RESTRICTED  
  
G/TBT/M/59  
 
8 May 2013  
(13-2438)  Page: 1/44  
Committee on Technical Barriers to Trade    
 
 MINUTES OF THE MEETING OF 6-7 MARCH 2013 
CHAIRPERSON: MR. SALIM LAHJOMRI 
NOTE BY THE SECRETARIAT1 
CONTENTS 
 
1   ADOPTION OF  THE AGENDA ........................................................................................ 1  
2   IMPLEMENTATION AND ADMINI STRATION OF THE AGREEMENT ................................. 1  
2.1   Statements from Me mbers under Article 15.2 ................................................................ 1  
2.2   Specific Trade Concerns.............................................................................................. 2  
2.2.1   New Concerns  ........................................................................................................ 2  
2.2.2   Previously Raised Specific Trade Concerns ................................................................. 16 
2.3   Exchange of Experiences ........................................................................................... 43 
2.3.1   Good Regu latory Pr actice ........................................................................................ 43 
2.3.2   Standards ............................................................................................................. 43 
2.3.3   Next Th ematic Sessions .......................................................................................... 43 
3   EIGHTEENTH ANNUAL REVIEW .................................................................................. 44  
4   TECHNICAL COOPER ATION ACTIVI TIES .................................................................... 44  
5   UPDATING BY  OBSERVERS ........................................................................................ 44  
6   DATE OF NE XT MEETING ........................................................................................... 44  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/4073. 2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
2.1  Statements from Members under Article 15.2  
2.1.  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 on e 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).  
                                               
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. 
2 http://tbtims.wto.org . G/TBT/M/59 
 
- 2 - 
 
  2.2  Specific Trade Concerns 
2.2.1  New Concerns 2.2.1.1  India - Electronics and Informat ion Technology Goods (Requirements for 
Compulsory Registration) Order, 2012 (G /TBT/N/IND/44 and G/TBT/IND/44/Add.1) 
(IMS ID 367) 
2.2.  The representative of Japan requested th at India postpone the enforcement date of the 
Electronics and Information Technology Goods (Requirements for Compulsory Registration) Order 
2012. He noted that Article 3 of the Order prohibited manufacturing, storing for sale, importing, 
selling or distributing products which did not conform to the Order after the enforcement date of  3 April 2013, which was six months from the date of  publication in the Official Gazette. However, 
Japanese industry estimated that it would take more than nine months to comply with all 
requirements in the Order. He additionally noted a la ck of testing laboratory capacity in relation to 
the Order; India had designated only four testing laboratories, all of which were located in India. 
For these reasons, the representative requested that India postpone entry into force to 12 months 
from the date of publication in the Official Gazette, at the earliest. 
2.3.  He requested that the Order apply only to products imported to India after the entry into 
force of the Order, and not to products imported prior the enforcement date. The representative 
noted that in many countries new rules are applied to only those products that are imported after 
the relevant enforcement date. Furthermore, he explained that Japanese exporters supplied "Goods" listed in the Order's "Schedule" to vari ous Indian dealers, and thus, it was nearly 
impossible to trace these complex supply chains. Should product stock in the market place be 
subject to the Order, it would place additional burdens on Japanese exporters and Indian dealers 
and retailers, namely: collecting products from markets; opening product packaging; replacing labelling affixed to the product; conducting qu ality control; and, repackaging the modified 
products.  He also requested India to accept certificates issued by Japanese Certification Bodies. 
According to the BIS Rule 16B (3), test reports were required from one of the four national testing laboratories designated by BIS. Given that In dia was a member of IECEE CB Scheme, he asked 
India to accept CB certificates issued by foreign certification bodies. 
2.4.  The representative of the United States  echoed the concerns expressed by Japan. She 
expressed confusion as to whether the Order was a proposed or final measure, given that the 
published measure included an entry into force timeframe and did not specify a final or revised 
measure being issued before then; the Order was published in the Official Gazette in September 
2012 with a public comment period until December 2012, and it was notified as G/TBT/N/IND/44 in October 2012. The representative further asked how comments would be taken into account 
given the April implementation date, and that this raised questions regarding India's 
implementation of its notification obligations under Articles 2 and 5 of the TBT Agreement. 
2.5.  Regarding testing, she noted that the BIS ha d identified only four recognized laboratories, 
each of those labs authorized to test only a small subset of products on the list. These laboratories 
did not appear prepared to handle the volume of products that would need to be tested, and she expressed concerns that this could lead to significant delays in placing products on the market. Moreover, it was unclear why in-country testing was required, and she asked why India deemed 
foreign labs inadequate to address product safety concerns. She understood that BIS was a 
signatory to the IECEE CB Scheme, and said that the four designated laboratories had no scheme 
categories in their scope for the office products regulated under the Order; moreover, it was not 
consistent with the CB Scheme requirement that si gnatories must agree a priori to accept reports 
of other signatories. 
2.6.  The representative said the scope of products subject to the Order remained unclear, and 
that the FAQs on the BIS website did not address concerns on this issue. In particular, the 
coverage of "automatic data processing machines" was unclear, and if this was intended to include large servers used by industrial consumers, her delegation questioned whether product safety concerns warranted in-country testing. Given, the confusion over many technical aspects of the 
Order, and testing issues, she strongly encouraged India to delay entry into force until such time 
as comments received from interested parties were fully taken into account in a revised final measure. G/TBT/M/59 
 
- 3 - 
 
  2.7.  The representative of the European Union supported the concerns raised by Japan and the 
US, and raised a further fundamental concern about the necessity and proportionality of the 
proposed compulsory registration system for the 15 types of electronic and information technology 
goods listed in the Annex to the Order. Mandatory third party testing by a laboratory approved by 
the BIS appeared excessively burdensome, and mo re strict than necessary, given the low risk 
nature of the products concerned. Examples of  covered products included laptops, printers, 
scanners, wireless keyboards, telephone answering machines, automated data processing 
machines, video game machines, CD/DVD players, and televisions, which were unanimously 
considered as very low risk products giving rise to a very low number of accidents.  
2.8.  He invited India to consider a lighter conformity assessment procedure that would rest on a 
supplier's declaration of conformity, without any mandatory third party intervention. This would 
provide manufacturers freedom of choice regarding the laboratory where any relevant test would 
be carried out, including the possibility to use in-house testing facilities at the manufacturing premises.  He reiterated concerns raised by other Members about delays and costs imposed by the 
Order and asked for clarification that the new rules would be applicable only to products placed on 
the market after the entry into force of the Order,  and those products already on the market would 
not be affected. Further, he requested confirmation that test reports and certificates issued by 
members of the IECEE CB schemes would be accepted, and likewise that applications from foreign 
conformity assessment bodies to carry out the te sting required by the Order would be accepted. 
He noted with appreciation bilateral discussion with  India prior to the meeting, and his delegation 
welcomed further formal confir mation on the points raised. 
2.9.  With respect to frequency of testing, the repr esentative of the EU said that the notified text 
required that testing be repeated every two year s even when the product had not been modified, 
which appeared excessively and unnecessarily burdensome. His delegation believed that testing 
should be repeated only if the product had been substantially changed in such a way that its safety 
properties were affected.  He also noted that In dian Standards were referenced for each product 
category listed in the Annex to the Order; compliance to these standards was mandatory. The 
representative understood that there were corresponding international IEC standards for each 
product category, and he asked about the relationship between the referenced Indian Standards and the corresponding IEC standards. 
2.10.  Regarding the registration procedure, he noted that the manufacturer would have to send 
the test reports to BIS for scrutiny, but it was not clear from the notified text how this procedure 
would be implemented, how long it would take, or if there was a time-limit within which BIS was required to give feedback to the manufacturer. Th is was important for providing predictability and 
legal certainty so that businesses could plan the time to market of their products. 
2.11.  The representative of Korea aligned his delegation with the concerns raised by other 
Members. He understood that this Order referred to  Indian Standards that were harmonized with 
relevant international standards. He also noted that the Order exempted manufacturers that adopt 
Supplier's Declaration of Conformity from on-site inspection by the competent Indian authorities, and he thanked India for reducing the compliance burden. His delegation respected the efforts of the Indian Government to protect consumer safety in respect of electronics and information 
technology goods. Korean companies, he said, would try to fulfil those requirements. 
2.12.  However, Korean companies were strugg ling with compliance due to a small number of 
designated testing labs as compared to the high demand for testing, and the resultant processing 
delays by designated laboratories. He further noted the need to register products with the Indian 
authorities after testing, and that it was impossible to complete these steps prior to 3 April 2013. He recalled that Article 2.12 of the TBT Agreement required Members to provide a reasonable time 
interval between the publication of technical regu lations and enforcement, and he requested India 
to provide a six month grace period. If the entry into force could not be postponed, he asked India to accept test report in accord ance with the IECEE CB Scheme. 
2.13.  The representative of Switzerland said his delegation shared the concerns of other Members 
regarding the Order. In particular, he encouraged India to clarify if the standards being used 
corresponded to international standards as per Ar ticle 2.4 of the TBT Agreement. Further, his 
delegation was not convinced that the conformi ty assessment procedure chosen was justified 
under Article 5.1 of the Agreement as necessary or proportional, since all the products mentioned 
in the Order were low-risk consumer electronics. He believed that a less burdensome system G/TBT/M/59 
 
- 4 - 
 
  based on Suppliers' Declaration of Conformity  could equally achieve the purposes of the 
legislation.  
2.14.  The representative requested that India treat registration as definitive, and thus that tests 
would be valid as long as products did not chan ge, which could reduce the burden on importers 
and avoid disruptions for products awaiting confirmation. In any case, he invited India to 
streamline the process by accepting conformity assessment according to the IECEE CB Scheme and other relevant international schemes for test results. 
2.15.  The representative of India stated that the Order would come into effect on 3 April 2013, 
and that a seven-month adaptation period had been provided from the date of publication of this 
order in the Official Gazette. He noted that ma ny of the queries raised by Members had been 
discussed with Indian authorities by the multinational companies representing concerned 
Members, and on this basis the Department of Electronics and Information Technology had 
prepared FAQs and guidelines for series approvals, and shared these on its website. The representative believed that many of the querie s raised by Members are answered in the FAQs, 
given these were the exact questions asked by the multinational companies during the 
consultation process. 
2.16.  He was of the view that this registration system was a more trade facilitating conformity 
assessment procedure than the previous third pa rty testing system. He asked Members to take 
into account the fact that most developing countries did not have well-developed post market surveillance systems, and that this registration sy stem helped to fill this gap. He said that the 
Order was only applicable for products manufactu red or imported after the Order's entry into 
force, as stated in the FAQs. Regarding testing ev ery two years, his delegation believed that this 
was a proven norm for ensuring compliance. He stated that the five testing laboratories recognized under the scheme would be able to handle the workload. The BIS was examining other 
applications from laboratories, including foreign laboratories. He observed that compliance should 
not be a problem for most exporters, since the Indian Standards were based on equivalent IEC standards. 
2.17.  Regarding the issue of international syst ems for conformity assessment and accreditation, 
he recalled a very healthy debate on this topic during the Sixth Triennial Review, and said this 
debate should continue. In his view, it was clear that Members with substantial imports and poor post market surveillance, especially developing countries, needed to develop their own testing 
laboratories. The registration system under discussi on fits with this purpose, because even under 
the current IEC CB Scheme, he noted that most of the laboratories were concentrated in developed countries. 
2.2.1.2  United Arab Emirates - Conformity  Assessment Procedure for Automobile Tyres 
(G/TBT/N/ARE/116) (IMS ID 368) 
2.18.  The representative of Japan expressed concerns about this measure, which entered into 
force on 1 September 2012. He noted that automobile tyres exported from Japan to the United 
Arab Emirates (UAE) had already satisfied the requirements of the Gulf Cooperation Council 
Standardization Organization (GSO) regulations, of which the UAE is a member. Under the GSO system, Japanese tyre manufacturers were requir ed to renew the GSO certification every year, 
and that this was one of the most stringent certification systems in the world. His delegation was 
of the view therefore that it was not necessary for the UAE to introduce a duplicative conformity 
assessment procedure in addition to the GSO sy stem, and he requested an explanation of the 
rationale and objectives behind this additional procedure. 
2.19.  The representative of the European Union echoed Japan's concerns, and said her delegation 
had sent written comments on this notification in October 2012 regarding divergences between the 
notified text and relevant requirements under UNECE Regulations. The UAE was asked to consider 
removing the ban on the importation of those retreated tyres which were certified as complying with UNECE Regulations 108 & 109, and to refrain from adopting a measure which would be disproportionate to the objective it aims to achieve. She requested that the products complying 
with UNECE Regulations for tyres be accepted on the market of the UAE, and requested an update 
on the state of play and the timeline for the revision of the measure. G/TBT/M/59 
 
- 5 - 
 
  2.2.1.3  Thailand - Certific ate Requirement and Administrative Measure Relating to 
Importation of New Pneumatic Tyres of Ru bber into the Kingdom of Thailand B.E. 
2555(2012) (G/TBT/N/THA/413)3 (IMS ID 369) 
2.20.  The representative of Japan voiced concerns on Thailand's import regulation for automobile 
tyres, published on 11 January 2013 and enteri ng into force on 12 January 2013. The measure 
obliged tyre importers to submit "Standard Assurance Certificates" and "Certificates of Origin" issued by the "competent author ity of exporting country", with the stated objective of the 
regulation to ensure economic stability and public safety. 
2.21.  He expressed four concerns; first, regarding the fact the regulation did not provide 
information on relevant standards. His delegation thus believed that this regulation was unnecessarily trade restrictive, and he requested that Thailand temporarily postpone entry into 
force. While his delegation had recently learned that Thailand was postponing entry into force until 
13 March 2013, he nevertheless believed this time frame was still insufficient to allow for adaptation to this new regulation.  Second, he expressed concerns about preparation of Standard 
Assurance Certificates for tyres, as Japan did not adopt technical regulation for tyres. Instead, he 
asked that Thailand accept a copy of a UNECE Re gulation Compliance Statement which was issued 
by a Designated Administrative Department of the United Nations. Third, he flagged concerns 
about application of the regulation to new tyres for research. According to the Article 6 of the 
regulation tyres for research were exempted. Howe ver, Thailand customs authorities have required 
Japanese industry to provide Standard Assurance Certificates and Certificates of Origin in respect of these tyres. His delegation requested Thaila nd to guide its customs authorities as to the 
exemption for new tyres for research. Fourth, he noted the date of entry into force of the 
regulation was just one day after the publication. This measure should have been notified by Thailand, and sufficient lead-time should have been  provided. He requested that Thailand at the 
very least take Japan's concerns into account in implementing the regulation, and respond 
promptly to Japanese industry enquires regarding the regulation. 
2.22.  The representative of the European Union supported Japan's concerns, and noted that this 
measure contained provision falling under the TBT Ag reement, but as it had not been notified WTO 
Members were denied the opportunity to analyse the draft and to comment. Moreover, the measure entered into force one day after publication, meaning that no transitional period was provided for implementation. She invited Thailand to notify the measure, and to postpone entry 
into force of the measure in order to allow sufficient time for exporters to adapt to the new 
requirements. 
2.23.  She noted that Article 4 of the Ministerial Announcement required Standard Assurance 
Certificates issued by the exporting country, an d she asked for clarification on the relevant 
standards subject to the required Standard Assurance Certificates. In particular, her delegation enquired as to whether certificates of compliance with applicable UNECE Regulations would be 
accepted by the Thai authorities. The represen tative expressed the view that the duties of 
importers outlined in Article 5 were unnecessarily burdensome, in particular, the storage requirements and monthly reporting obligation. She asked whether similar duties applied to 
domestic producers. Finally, she sought clarification from Thailand about the purpose of the 
measure and the legitimate objectives pursued. 
2.24.  The representative of Thailand explained that her country was facing problems due to 
importation of low standard tyres. Her authorities deemed it necessary to urgently establish a 
measure to solve problems arising from the import of the tyres which did not comply with the 
relevant standards, so as to avoid risks associated with loss of life and assets. This technical regulation of the Ministry of Commerce was considered as the means to solve these urgent safety 
problems. 
2.25.  However, she announced that the date of enforcement of this technical regulation would be 
postponed to 13 March 2013, and that in the meantime the measure had been notified to the TBT Committee. Her delegation offered to provide copies  of the technical regulation upon request. On 
the other concerns raised, she would consult with her capital for an appropriate response. 
                                               
3 Listed as "Thailand- Import Regulation for Automobile Tyres" in JOB/TBT/45. G/TBT/M/59 
 
- 6 - 
 
  2.2.1.4  Chile – Proposed amendment to the Food Health Regulati ons, Supreme Decree 
No. 977/96 (G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1) (IMS ID 370) 
2.26.  The representative of the United States ex pressed concerns with Chile's proposed regulation 
implementing Law No. 20,606 on nutrition and co mposition of food and its advertising. Her 
delegation was of the view that the draft regulation lacked critical information needed to assess 
trade impacts, such as: explanation of application to foods served in restaurants; application to existing commercial inventory; and, whether imports can comply through the use of supplemental 
labels or stickers. She noted that this measure addressed the definition of serving and portion size, 
and that this was related to nutrient limits – on which Chile had recently submitted a notification.  
2.27.  US industry had voiced concerns with this proposed measure: on its mandatory nature; 
stringent requirements for the critical nutrients; and, the large number of products that could have 
to bear front-of-pack (FOP) icons and undergo relabeling. Her delegation believed this was the 
most onerous proposed measure of its kind to date, and that it may constitute an unnecessary obstacle to international trade. She asked if Chile had considered less trade restrictive approaches 
to promoting healthy diets, and if Chile had fully considered the potential impact of the proposed 
labelling and related criteria on the range of foods affected. 
2.28.  The representative noted alternative approaches contained in Codex guidance, which 
provide consumers with information to make appropriate dietary choices and reduce their risk of 
diet-related Non-Communicable Diseases. She cited for example, the Codex Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997) and the Codex Guidelines on Nutrition Labelling (CAC/GL2-1985), which establish conditions for vol untary "low", "free", or "no added" claims in 
tandem with mandatory nutrition labelling. As a result of Codex work to implement the WHO 
Global Strategy on Diet, Physical Activity, and He alth, the mandatory list was recently expanded to 
include saturated fat, sodium, sugars (and consideration of trans fatty acids in countries where this 
nutrient is a public health concern).  
2.29.  Since Chile already maintained requirements for mandatory nutrition labelling, she 
suggested a further option of expressing the nutri ent content of a food as a percentage of food 
label daily intake reference values, which was common practice in other countries. She explained 
that this approach, in conjunction with mandatory nutrition labelling and nutrition education, helped consumers understand that all foods may be consumed in the context of a total diet, but those high in certain nutrients may need to be limited. Moreover, Codex had recognized the 
important role of Nutrient Reference Values (NRVs) for labelling purposes in implementing the 
WHO Global Strategy on Diet, Physical Activity, and Health, evidenced by recently proposed NRVs 
for sodium and saturated fat in the Codex Committee on Nutrition and Foods for Special Dietary 
Uses. 
2.30.  She referenced Codex Guidelines on Nutrition Labelling (CAC/GL2-1985), Section 5 
recommendations in on Supplemental Nutrition Information: "Supplementary nutrition information 
is intended to increase the consumer's understanding of the nutritional value of their food and to 
assist in interpreting the nutrient declaration. There are a number of ways of presenting supplementary nutrition information to consumers that may be suitable for use on food labels". Furthermore, she cited Codex Guidelines on Nutrition Labelling (CAC/GL2-1985): "The use of 
supplementary nutrition information on food labels should be optional and should only be given in 
addition to, and not in place of, the nutrient decl aration." She asked Chile to explain why existing 
mandatory nutrition labelling requirements did not meet its public health objectives, how a 
mandatory supplemental label would address la ck of understanding among consumers, and 
whether Chile had undertaken consumer studies to support their proposal. 
2.31.  On the current timetable for implementati on by July 2013, she said this did not leave 
sufficient time for industry compliance or discussion of trading partners' concerns. Her delegation 
requested that Chile delay finalization and implem entation of its regulation to allow: adequate 
dialogue and consideration of comments from stak eholders; a discussion of the rationale, details 
and potential impact of this proposed regulatory approach, as well as alternative approaches 
considered; and, Chile's assessment of the costs and benefits associated with the proposed 
mandatory labelling requirements. G/TBT/M/59 
 
- 7 - 
 
  2.32.  The representative of Mexico voiced her delegation's concerns with the measure.  These are 
contained in full in document G/TBT/W/361. 
2.33.  The representative of the European Union was concerned that the overarching Law No. 
20,606 on the Nutritional Composition of Foods and their Advertising had not been notified, and 
hence WTO Members did not have the opportunity to comment. Article 5 of the Law established 
that the Ministry of Health would determine catego ries of foods that would need to be labelled as 
"high in calories", "high salt" or an equivalent designation and would also determine the content, 
form, size, messages, signs or pictures used for the labels. 
2.34.  While her delegation fully shared Chile's public health concerns regarding the provision of 
adequate nutritional information to consumers, she expressed doubt that the approach taken in the notified draft was the best way to achieve these objectives; or moreover, if the approach was 
proportional to the aim pursued, which was to empower consumers to make informed dietary 
choices in order to foster effective competition and consumer welfare. She expressed that "high in" warnings, such as those proposed by the Chilean le gislation, should be avoided, as they are not 
foreseen by the applicable Codex guidelines on nut rition labelling, and they risk demonizing some 
foods whose consumption in moderation can be part of a healthy diet. The representative explained that Chile's approach would have a discriminatory effect on foreign manufacturers, 
which would need to adapt their packaging for the Chilean market only. Her delegation invited 
Chile to consider less trade restrictive information measures. 
2.35.  She noted that an obligation to provide nutritional information was already established by 
Article 2 of Law No. 20,606, and she thus enquired as to the rationale for imposing additional 
warnings, and to compatibility with Article 2.2 of the TBT Agreement. She recalled that Codex 
Guidelines on Nutrition Labelling (CAC/GL 2-1985) state 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". She noted that no nutrient thresholds have been established by Codex for the nutrients targeted by the Chilean legislation. 
Moreover, while her delegation recognized that for certain nutrients there was evidence of a 
positive association between intake and the risk of developing a disease or disorder, there was no scientific evidence suggesting an identifiable thre shold above which the risk exists. Rather, the risk 
increased continuously when the nutrient intake was above the levels recommended by 
nutritionists. 
2.36.  The representative said that with respect to portion sizes the EU was currently analysing 
Chile's recent notification, and it would submit comments in due time. Also, according to the 
notified draft amending food safety regulation, 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; be located in the upper right corner; and, have a size of at least 4 square centimetres. 
These burdensome requirements raised concerns  regarding the labelling of small packages; 
furthermore it was not clear if stickers would be accepted in order to comply with the regulation. Her delegation asked for clarification of these issues, and, should the additional warnings eventually be imposed, asked Chile to consider less restrictive size and placement requirements – 
the current proposal would entail re-design of the packaging of a large majority of products 
concerned by the warning sign. 
2.37.  Finally, she asked Chile to share information on the foreseen deadlines for the entry into 
force of these requirements; Law 20,606 was scheduled to come into force on 6 July 2013 
according to Article 11. She stressed that adaptation to the new requirements would require significant investment for manufacturers, and a redesign of the packaging for some categories of 
products which were not yet defined. Therefore, her delegation requested that Chile postpone the 
entry into force, and provide a reasonable implementation period in accordance with Article 2.12 of the TBT Agreement. For example, EU legislation on nutritional labelling was adopted in 2011, but 
would only come into force in 2014. 
2.38.  The representatives of Argentina and Colombia echoed concerns expressed by the US, 
Mexico and the EU; Argentina stressed in particular that the measures were not in line with Article 
2.2 of the TBT Agreement and would affect negatively the bilateral trade. Argentina announced 
that it would submit comments to the notified drafts. G/TBT/M/59 
 
- 8 - 
 
  2.39.  The representative of Guatemala, while sh aring Chile's objectives of providing consumer 
information and adequate health education to mitigate problems such as obesity, voiced serious 
concerns. He said that the measures in question would not fulfil their legitimate objectives, and that they thus constituted an unnecessary obstac le to international trade under Article 2.2. 
Additionally, he was concerned about transparency and opportunity to provide comments. Chile 
rejected two requests from Guatemala for an extension of the comment period, and Guatemala continued to have a number of questions, such as the international standards that were taken as 
the basis for the measure. He again asked Chile to reconsider the possibility of extending the 
comment period to give opportunity to his delegation to comment, and also that Chile re-examine the measures to ensure that they do not create unnecessary trade restrictions. 
2.40.  The representative of Canada was concerne d that this regulatory proposal would have a 
negative impact on Canada's significant food ex ports to Chile. In particular, she expressed the 
view that it had not been properly notified, deviated from international standards, had no apparent scientific basis, and was likely to be more trade restrictive than necessary. Her delegation 
supported Chile's policy objective of promoting healthy dietary choices and reducing obesity and 
related non-communicable diseases, but she encouraged Chile to consider a less trade restrictive alternative. Additionally, due to the lack of tr ansparency, the representative reiterated other 
Members' requests for an extension to the comment period. 
2.41.  The representative of Peru echoed concerns of other delegations, and requested that Chile 
reconsider her delegation's request for an extension of the comment period. Moreover, she was 
concerned about the upcoming entry into force of the measures, and asked Chile to reconsider the 
implementation timeframe. 
2.42.  The representative of Chile said that the proposed amendment to the Food Health 
Regulations, Supreme Decree No. 977/96 sought to solve intractable health problems. Her country 
was experiencing an obesity epidemic, especial ly amongst young people who consume a large 
amount of these food elements. She explained th e amendment would communicate specific health 
information and provide a warning that would be easily understandable for consumers, and guide 
them to the best consumption choices based on available information. Her delegation was holding 
meetings with public and private sector bodies on this matter, and she said that concerns of Members, especially regarding the time-frame for entry into force, would be communicated to her 
capital based authorities. 
2.2.1.5  Korea – Proposed SAR Values or EMF exposure in cell phones 
(G/TBT/N/KOR/393) (IMS ID 371) 
2.43.  The representative of the United States reported that American industry had submitted 
comments on Korea's proposed labelling regime for cell phones. She sought clarification as to the 
rationale for requiring two labelling categories for the Specific Absorption Rate (SAR) for cell phones, when both categories of products covered by the measure had already met Korea's safety 
requirements. Moreover, she was not aware of any scientific evidence or basis for differentiating 
between the two categories of products on health criteria. Finally, she noted that this regulation had not advanced in some time, and she asked for clarification about its current status, and whether her delegation's comments would be taken into account. 
2.44.  The representative of the European Un ion voiced concerns with Korea's "Proposed 
enactment of the rating of electromagnetic waves for mobile phones and radio stations". Her 
delegation had submitted comments on this noti fication on 14 November 2012, but had not yet 
received a reply. While her delegation fully shar ed the objective of better informing consumers of 
SAR, she believed that the requirement to la bel the SAR on the packaging of mobile 
communications wireless equipment, personal portable phone wireless equipment and portable 
wireless devices used in proximity to the ear, could be replaced by less trade restrictive measures 
such as user manuals or information websites. Th e representative enquired as to the scientific 
justification for classifying products as Level 1 or Level 2 on the basis of SAR value; her delegation was of the view that there was no need for specific labelling by levels since both fell below 
internationally accepted thresholds ensuring safe use of the products. 
2.45.  The representative of Korea explained th at its mandated SAR threshold for mobile phone 
was 1.6W/kg, which was identical to that of th e US. However, he noted that since the WHO had G/TBT/M/59 
 
- 9 - 
 
  pronounced in May 2011 that electromagnetic waves emitted from mobile phones had the 
potential to cause cancer, health concerns had significantly increased worldwide, including in Korea. He noted a consumer survey conducted by Korea Communications Commission, which showed that 82% of consumers were concerned about the dangers of electromagnetic waves. 
2.46.  In response, a proposed SAR Grading Sc heme was designed to help consumers better 
understand SAR values. His authorities did not intend to arbitrarily discriminate between products by grade, or to mislead consumers. He explai ned that mobile phones satisfying the 1.6W/kg 
threshold would have no problems accessing the Ko rean market. However, taking into account the 
concerns of interested parties, he said Korean authorities were reviewing this proposal, including the display methods and grace period. The representative would deliver other concerns raised to the competent authorities. 
2.2.1.6  Russian Federation – Alcoholic Be verages Storage Technical Conditions Order 
Number 59n (IMS ID 372) 
2.47.  The representative of the United States recalled her delegation's November 2012 
intervention on this measure4, and noted that American exporters were still encountering 
difficulties. She encouraged Russia to perform inspections and licensing of alcoholic beverage warehouses in a timely and transparent manner, with clear instructions available. Moreover, her 
delegation believed that businesses should be allowed to renew licenses well before expiration. 
She requested a response to US comments on th is measure, sent 28 August 2012. Finally, she 
hoped that Russia would act consistently with the TBT Agreement, and adopt measures that do not 
create unnecessary obstacles to trade. 
2.48.  The representative of the Russian Federation  explained that this Order set requirements for 
warehousing of alcohol products. The legislation was currently being finalized, in compliance with 
WTO rules. He said the comments of the US had been carefully examined, and additional 
clarifications and discussions could continue on a bilateral basis. 
2.2.1.7  India – Proposed Amendment to 2008 Hazardous Waste Law (IMS ID 373) 2.49.  The representative of the United States no ted that India's Ministry of the Environment and 
Forests was considering adopting a "Fifth Amendment" to its 2008 Hazardous Waste Rules, the 
draft of which was provided selectively to member s of the Indian industry for their input. Her 
delegation was disappointed that the previous four amendments to the Hazardous Waste Rules 
were not notified to the TBT Committee. She expressed regret for such an approach which, besides 
disadvantaging foreign competitors, was unlikely to help India meet the objectives underlying the 
Hazardous Waste Rules since the Indian market relied on imports for many of the products 
covered by these Rules, such as electronic and electrical equipment. She hoped the Fifth 
Amendment would be notified to the TBT Committee, giving stakeholders an opportunity to 
provide comments. 
2.50.  The representative of India replied that if India did proceed with an amendment to this law, 
it would be notified at the draft stage to the WTO. 
2.2.1.8  Ukraine - Amendment to Law on Adve rtising, Law of Ukraine No. 3778-VI of 16 
March 2012 (G/TBT/N/UKR/89) (IMS ID 374) 
2.51.  The representative of the United States thanked Ukraine for notifying this measure, which 
was commented on by the US industry through the Enquiry Point. She asked whether Ukraine 
planned to take into account the comments received. She also sought specific updates on, first, the implementation of the provisions of this me asure with respect to alcoholic beverages and, 
second, on the rational and objective of extend ing to alcoholic beverages the application of a 
measure that targeted primarily tobacco. 
2.52.  The representative of Ukraine explained that  the Ministry of Health of Ukraine had notified 
the new Law amending a number of advertisement la ws and regulations. The Law prohibited direct 
and indirect advertising, sponsorship and promotion of tobacco products. In addition, the Law also 
                                               
4 G/TBT/M/58, Page 26, paragraph 2.133.  G/TBT/M/59 
 
- 10 - 
 
  included some limited specific obligations relating to alcohol advertising. The comprehensive ban 
on tobacco advertising was a necessary element of Ukraine's tobacco control policies and confirmed Ukraine's commitment to the protection of public health in general and the reduction of smoking prevalence in particular. Advertisement bans for tobacco products have been adopted by 
many countries in the world and were supported by a body of evidence that they were able to 
genuinely contribute to the protection of public health. Ukraine's Law, however, drew an important 
distinction between advertising, on the one hand , and the legitimate use of validly registered 
trademarks on tobacco products to which they we re to be applied, on the other. Trademarks 
themselves, when used on the product or the packaging, were not advertising and were thus not affected by the Law. However, what was prohibit ed by the Law was advertising that used signs 
including trademarks to promote the product. For example, the Law banned indirect advertising by 
placing images of tobacco products or tobacco trademarks on consumer goods not related to the 
use of tobacco products. 
2.53.  The representative of Ukraine explained th at the Law protected the use of trademarks on 
tobacco products or their packaging, while ensuring that all direct and indirect forms of advertising 
for tobacco products were prohibited. Trademarks served the important function of distinguishing 
lawfully available products. They merit special prot ection in that function and are protected also 
under the Law (that was why the Law only prohibited the placement on tobacco products, or their 
packaging, of words, drawings or other images other than aspects of protected trademarks). The 
Ukrainian Law banning tobacco advertising was a le gitimate public health measure that balanced 
effective health protection, on the one hand, and appropriate protection for trademarks and 
market access rights, on the other. Therefore, Ukraine considered that this Law, unlike other 
tobacco control measures previously discussed in the TBT Committee or the TRIPS Council, did not act as an unnecessary obstacle to trade and was consistent with the TRIPS Agreement, thus 
complying with Ukraine's obligations under WTO law. Further, the few specific requirements 
relating to advertising for alcoholic beverages intr oduced by the Law were similarly consistent with 
Ukraine's obligations under WTO law. In fact, the alcohol-related requirements in the Law 
concerned advertising and were thus not subject to the disciplines of the TBT Agreement given 
that these advertising requirements did not relate to product characteristics or the labelling or packaging of alcoholic beverages. Additionally, the requirement that alcohol-related trademarks 
were not allowed to be placed on products that were not similar to alcohol, or not associated with 
alcohol, did not apply to an "identifiable product or group of products" but rather concerned a very 
broad range of widely diverse products and the pr ohibition on indirect advertising for alcohol was 
thus not a technical regulation. Incidentally, this  was the approach adopted by the WTO Appellate 
Body in EC Asbestos and EC Sardines: a technical regulation was a measure that applied to an 
identifiable group of products, for which it imposes certain product-related requirements compliance with which was mandatory (Appellate Body Report, EC – Sardines, Para. 176). Thus, 
the prohibition on indirect advertising for alcoholic products, which already existed in a less 
comprehensive form before the new Law, did not constitute an unnecessary obstacle to trade in non-alcoholic products. This requirement was ra ther an accepted way of curbing indirect 
advertising for alcohol products. The same reasoned justification that existed for banning indirect 
advertising for tobacco products - a measure that was widely accepted in the international 
community as an effective, proportionate and legitimate means of addressing a public health concern - would apply with equal force to indirect advertising for alcoholic products. 
2.2.1.9  Canada - Improved food insp ection model: The Case for Change 
(G/TBT/N/CAN/365, G/TBT/N/CAN/365/Rev.1, G/TBT/N/CAN/365/Rev.1/Add.1, G/TBT/N/CAN/365/Rev.1/Add.2) 
2.54.  The representative of China requested the Ca nadian authorities to base any changes in their 
measures on relevant international standards, such as Codex standards. His delegation looked 
forward to receiving the notification of this measure and the opportunity to send comments. 
2.55.  The representative of Canada explained that Canada was developing a more consistent and 
comprehensive inspection approach that could be applied across all foods. Canada was consulting 
with Members and Canadian stakeholders on ways that its site-based inspection system could be 
enhanced to best manage current food safety challenges and emerging trends. Canada had 
already provided two opportunities for Members to comment on items related to this initiative. The 
first opportunity, in June 2012, sought comments on the document called "The Case for Change" - which outlined the proposed core components of an improved inspection model in 
G/TBT/N/CAN/365. Canada thanked both China and all the other Members for reviewing and G/TBT/M/59 
 
- 11 - 
 
  considering this concept document and for providing comments. These comments were taken into 
account when developing the draft improved food inspection model. The second opportunity, in August 2012, sought feedback on the draft improved food inspection model in G/TBT/N/CAN/365/Rev.1. During this second roun d of consultations Canada received comments 
from various Members. Canada intended to notify a second draft of the improved food inspection 
model for comments shortly. 
2.2.1.10  Korea - Draft amendment of Ordinance and Regulation of Motor Vehicle Control 
Act (G/TBT/N/KOR/342 and G/TBT/N/KOR/342/Add.1) (IMS ID 375) 
2.56.  The representative of the European Unio n noted that Korea had not responded to comments 
on this notified draft sent by her delegation on  1 March 2012. This notified draft announced the 
introduction of a system of self-certification of certain car parts. The manufacturers or importers of 
these parts would have to: (i) be registered with the relevant Korean authority (the Ministry of 
Land, Transport and Maritime Affairs - MLTM); (ii) submit their products for testing by a testing facility designated by the MLTM; and then (iii) apply the self-certification mark on the product 
before placing it on the Korean market. However, there were no details as to how the registration, 
testing and self-certification procedures would be carried out, or as to the certification mark itself. She recalled that in its comments of March 2012, the EU requested that car parts certified as 
complying with UN Regulations, and marked with the "E-mark", be accepted on the Korean market 
on the basis of UN certification and marking, without the need for an additional Korea-specific mark, in accordance with Article 2.4 of the TBT Agreement. 
2.57.  She also noted that her delegation had lear ned that additional implementing legislation to 
the Motor Vehicles Control Act – MLTM Notice no. 2013-70 on "Guidelines for Motor Vehicle & 
Vehicle Parts Self-Certification" - had been publis hed by the MLTM on 22 February and entered into 
force on the same day. This Notice specified the details of the registration, testing and self-
certification procedure. It also stipulated that the products should be marked with the Korean KC 
mark in an indelible manner, and that stickers would only be allowed if the part was too small or if the engraving of the KC mark affected the parts'  performance. The EU requested Korea to notify 
these Guidelines to the TBT Committee, in accordance with its obligations under Article 5.6 of the 
TBT Agreement, and suspend their application unti l Members have had an opportunity to provide 
comments, which should be taken into account. It also requested Korea to provide a reasonable period - of at least six months - between the publication of the Guidelines and their entry into 
force. The EU reiterated its request for Korea to accept UN certification and marking as an 
alternative to the KC mark and, in the meantime, to  allow the affixing of the KC mark by means of 
a sticker in all cases (i.e. not only when the part was too small or its performance was affected).  
2.58.  The representative of Korea explained that the purpose of this measure, which was similar 
to those from other Members, including the EU, was to protect customers from low graded and 
defective products. Regarding the notification, he recalled that the EU had consistently requested 
Korea, according to the provisions of the EU-Korea FTA, to accept parts with E-mark which meet 
the safety standards instead of KC-mark. Howeve r, given that there was no provision regarding 
the recognition of E-mark, Korea was unable to accept this request. In order to ease the burden of automotive parts manufacturers, Korea allowed manufacturers not only to carve the KC mark on 
the parts but also to print it or mark it indelibly.  Moreover, in the case where the size of the parts 
was too small that self-certification could not be marked over 1.5mm of length, stickers were also allowed. A 3-month-grace time was also granted to give enough time to manufacturers to adapt. 
He also informed that the final regulation of self-certification for automotive parts was 
promulgated on 22 February 2013 and had since ente red into force. Furthermore, after notifying 
the regulation on December 2011, Korea believed that it had made significant transparency efforts 
with respect to this measure by: (i) informing domestic and international manufactures about the 
regulation; (ii) reflecting comments of other Memb ers for two years; (iii) granting a 3-month grace 
period so as to ease the burden of manuf acturers and give enough time to adapt. 
2.2.1.11  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/88) (IMS ID 377) 
2.59.  The representative of Nicaragua said that his delegation was concerned with the proposed 
directive. He wondered whether the high level of protection sought by the draft measure was 
proportional to the legitimate public health objectives and whether it was not more trade G/TBT/M/59 
 
- 12 - 
 
  restrictive than necessary to attain such goals. The EU imposed strict obligations with respect to 
disclosure of ingredients which must be met before a tobacco product can be marketed. The draft directive provided that manufacturers should not only provide all of the toxicological information with respect to the product concerned but also should present a report on the inclusion of such 
ingredients. Nicaragua asked the EU to explain the rational of such requirements. The draft 
directive also provided that Member states may require manufacturers or importers to carry out 
other tests to assess the health effect of substances bearing in mind the problems of addiction and 
toxicity. Nicaragua considered that the imposition of other non-specified tests was not in line with 
the goal of harmonizing legislation in the EU. Wh at were these "other non-specified tests"? Would 
the tests for addiction and toxicity impact, inter alia , what proof would be  necessary? How would 
the EU ensure that these other non-specified tests within EU member States not constitute 
arbitrary and unnecessary barriers to trade? With su ch obligation of disclosing ingredients, the EU 
would endanger industrial secrets and other confiden tiality of producers. In this respect, Nicaragua 
asked what was the public health objective pursue d by forcing manufacturers to provide internal 
and external studies on marketing and with respec t to other groups of consumers on ingredients 
and forcing manufacturers to provide volume sales for each product and for each member State.  
2.60.  Nicaragua also asked what scientific evidence  was used by the EU to justify the ban on all 
tobacco products with characteristic flavours as there seemed to be no indication anywhere that 
these products, in particular those with regular flavour, were harmful to health. Nicaragua also asked what would be the maximum levels of additives with respect to the preparation of a positive list of prohibited additives. Additionally, what scientific evidence was used as a basis to impose a 
strict ban on these specific additives, irrespectively of whether they impart a characteristic flavour? 
In fact, certain additives did not impart a characteristic flavour and there was no evidence that they increase the toxicity or dependence on the product. What was thus the basis for banning such 
additives? What was the reason for providing a similar prohibition for characteristic flavours of 
cigars, and other tobacco products, which were currently exempt from the measure? Would it simply be because the market quota for these particular tobacco products had increased by a 
given percentage? He also noted that the proposed directive, purportedly based on the Appellate 
Body report in US - Clove Cigarettes, covered a ll flavoured tobacco products, including "menthol" 
and "clove". He also noted that the analysis of the Appellate Body in that case, which led to a finding of de facto  discrimination under Article 2.1 of the TBT Agreement, were, however, based on 
the specific circumstances of the domestic market of tobacco products at issue.  
2.61.  With respect to the requirement for a health warning, he observed that the EU mentioned, 
as a basis, a 2009 report, which was commissioned by the EU itself. The EU proposed measure 
was also based on the experience of other countries that use major graphic health warnings. This 
however did not show if the use of such warnings had made a material and quantifiable contribution to the objective of protecting human health. Nicaragua asked the EU for other studies 
and evidence that, in the EU's view, would consti tute new scientific evidence to support a direct 
causality between the requirement for the warning and the objective of providing a high level of 
health protection. Additionally, Article 12 of the proposed directive prohibited any information in the labels and packaging of tobacco products that  promoted these products by means that were 
"false, misleading, deceptive or likely to create an erroneous impression about [their] 
characteristics, health effects, hazards or emis sions". However, the proposed directive did not 
define "misleading", what was particularly confusing and deserved a more precise definition. 
Further, with respect to the draft directive's proh ibition of symbols, marks or other signs in the 
packages of certain tobacco products, Nicaragua asked whether the EU had considered its obligations under the TRIPS Agreement when devising such obligation. More specifically, Nicaragua 
asked what "false, misleading and deceptive" me ant with respect to registered trademarks for 
tobacco products that include in them reference to the flavour of these products. Would the product prohibition ban in Article 12 of the prop osed directive apply in such cases? Another 
element of concern was the prohibition of "misleading colours" in Article 12(2) of the proposed 
directive. In this respect, Nicaragua asked the EU to clarify, first, how misleading and non-
misleading colours would be differentiated, and, second, to provide scientific evidence supporting 
the claim that banning the use of colours contribu ted to the achievement of the legitimate human 
health objective. Nicaragua also asked for the scientific evidence that supported the rule in Article 
12(2) of the proposed directive, according to wh ich "cigarettes with a diameter of less than 7.5 
mm shall be deemed to be misleading." Why did th is presumption applied only to slim cigarettes 
and not, for instance, also to cigars ("puros") with identical diameter? Nicaragua also asked the EU 
to explain the basis for requiring that cigarette packages be cuboid in shape. In Nicaragua's view, there was no evidence showing that the shape of  the package protected human health. Finally, G/TBT/M/59 
 
- 13 - 
 
  Nicaragua asked the EU for detailed information on the scientific evidence justifying the distinction 
made between, in one hand, cigarettes and "roll-your -own tobacco", and, on the other, cigars and 
other tobacco products. What was the scientific evidence showing that smoking cigars was less harmful than smoking cigarettes? 
2.62.  The representative of the Dominican Repu blic expressed serious concern about the impact 
of the measures proposed by the EU with respec t to their consistency with the TBT Agreement. 
The full statement is contained in G/TBT/W/358. 
2.63.  The representative of Indonesia associated his delegation with the concern expressed by the 
Dominican Republic and Nicaragua. Indonesia no ted that while the proposed measure exempted 
certain tobacco products, such as cigars, cigarillos and pipe tobacco, from some provisions (such as the prohibition of products with characterizing flavours), such exemptions shall be removed if 
there would be a substantial change of circumstance s in term of sales volume or prevalence level 
among young people. In this regard, Indonesia asked the EU to clarify what would be the amount of volume actually defined for these exemptions. 
2.64.  The representative of Guatemala stated that his delegation shared the policy objectives of 
the EU to improve public health by discouraging people from using tobacco products. However, it 
was not clear to Guatemala how the proposed EU measure would achieve the purported legitimate 
objectives. In any case, this measure appeared to  be more trade restrictive than necessary to 
achieve such objectives. The EU should therefor e consider less trade restrictive alternatives. 
2.65.  The representative of Malawi expressed se rious concern about the impact of the measures 
proposed by the EU with respect to their consis tency with the TBT Agreement. The full statement 
is contained in G/TBT/W/360. 
2.66.  The representative of the Philippines associated her delegation with the concern expressed 
by the Dominican Republic and Nicaragua. She noted that the proposed measure would ban 
certain tobacco products with a characterizing flavour and that there were exemptions to this ban. 
Like Indonesia, the Philippines sought clarification and further information on the criteria for the threshold to be used on the surge in the consumption of the exempted products. Further, with 
respect to the criteria for the regulation of ingredients pertaining to characterising flavours, 
particularly as it related to tobacco products currently exempted from the ban, she noted that 
cigarettes made of several types of tobacco contai ned several additives. Th ese additives, however, 
were not used to give characterizing flavour to th e product; rather, they were used as an essential 
component to mitigate the strong flavour, like in the case of burley tobacco, where natural sugars 
and flavours were destroyed by the curing process. 
2.67.  The representative of Honduras expressed her delegation's commercial interest in this 
matter, in particular the answers to the question s posed to the EU by the preceding delegations 
during this meeting. 
2.68.  The representative of Mexico asked for more clarification about the proposal's prohibition of 
misleading information in its Article 12, a rule linked to the use of trademarks. She also asked the 
EU for the scientific and technical justification to require that tobacco products be sold in packages of at least 20 units and that a unit packet of "roll-your-own" tobacco contain tobacco weighing at least 40g. She further noted that the proposed directive required that all cigarette packages and 
"roll-your-own" tobacco contain a single, EU-wide "tracking and tracing system" and a "common 
security feature". Mexico asked the EU to further explain the reason for such measures, including the costs for their implementation. Mexico was concerned that this proposed directive could be 
more trade restrictive than necessary within the meaning of Article 2.2 of the TBT Agreement since 
there could be other less burdensome means to achieve the legitimate objectives of protecting human health. In this respect, Mexico asked the EU for any scientific and technical evidence 
supporting the approach taken to deal with the attr action to the public of tobacco products when 
packaged. She recalled that Article 2.8 of the TB T Agreement provides that Members must base 
their technical requirements "in terms of performance rather than design or descriptive characteristics". This draft measure may not comply with such provision since it dealt with the 
packet itself rather than restricting the use of tobacco. G/TBT/M/59 
 
- 14 - 
 
  2.69.  The representative of Norway stated that public health and tobacco control were topics of 
particular interest to her delegation, and that Norway supported the EU in its efforts of combatting 
the tobacco epidemic. She praised the EU for having notified the proposed measure at such an early stage in the process. In Norway's view, it was within the right of each WTO Member to adopt 
measures which were necessary to protect public he alth, as long as they were consistent with the 
WTO Agreements. It was Norway's firm opinion th at the FCTC and the relevant WTO Agreements 
were mutually supportive, and that it was theref ore possible to implement measures intended to 
regulate the packaging of tobacco products in line with both sets of binding obligations. 
2.70.  The representative of New Zealand reiterated his delegation' view that Members had the 
right to regulate the protection of human health and safety, in particular in the important area of 
tobacco control. New Zealand trusted that the EU would regulate in a manner that would be 
consistent both with EU member States ob ligations under WTO Agreement and with their 
obligations under the FCTC.  
2.71.  The representative of Cuba stated that her capital was still reviewing the EU draft and 
reserved the right to intervene subsequently on this matter. 2.72.  The representative of Zambia stated that her delegation shared the concerns raised by the 
previous delegations. While Zambia shared the public health objectives outlined in the EU 
notification, it believed that the proposed measur es seemed to be excessive and could potentially 
have implications for the EU's obligation under the WTO Agreements. Zambia asked the EU to explain the draft measure's prohibition of additives and its relation with health benefits. She also asked whether there was a list of such prohibited additives and what measures and comparators 
EU intended to use in order to determine the degree of toxicity or addictiveness. 
2.73.  The representative of Nigeria stated that her delegation associate itself with the concerns 
raised by several delegations on this EU proposal with respect to the prohibition of tobacco 
products containing any additives as flavours to cigarettes.  
2.74.  The representative of Zimbabwe was concerned with EU proposed measure's restrictive 
effects on trade from, and negative impact on  tobacco producing of, developing countries.  
2.75.  The representative of Australia said that , according to the WHO, approximately one person 
died every six seconds due to tobacco. Tobacco killed nearly 6 million people each year. 
Unchecked, tobacco related deaths could increase to more than 8 million per year by 2030. Given these facts, Australia welcomed the EU's notification on tobacco products directive proposal. In 
addition to mandating increased graphic health warnings, under the proposal, Australia understood 
EU member States were allowed to implement plain packaging of tobacco products as far as compatible with the directive and EU law. The pr oposed EU directive was, in Australia's view, a 
legitimate measure designed to achieve a fundamen tal objective: the protection of human health, 
in particular the protection of young people against smoking initiation and uptake. Like Australia, the EU was a strong supporter of effective tobacco control and both shared common goals as 
parties to the WHO FCTC. In this respect, Australia noted that one of the objectives of EU proposal 
was precisely the implementation of the FCTC. Finall y, Australia was of the firm view that Members 
had the right to implement measures necessary to protect human health while complying with relevant international treaty obligations, including the TBT Agreement. 
2.76.  The representative of the European Unio n explained that the new proposal, which was put 
forward by the European Commission on 19 December 2012, was meant to replace the current 
Tobacco Products Directive 2001/37/EC. It had been notified to this Committee as notification 
G/TBT/N/EU/88 on 18 January 2013, and WTO Members were being provided 90 days to comment 
on the draft, i.e. until 18 April 2013. After this period, the proposal would go through the EU's legislative process, in which both the European Co uncil and the Parliament 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. 
2.77.  The representative of the EU explained th at, as its name suggested, the current applicable 
EU legislation, Directive 2001/37/EC, had been adopte d over 10 years ago. During this time, there 
had been various scientific and international developments in the area of tobacco control, as well G/TBT/M/59 
 
- 15 - 
 
  as changing trends in the market for tobacco prod ucts and in consumption patterns. Most notably, 
in the international context, the WHO Framewor k Convention on Tobacco Control (FCTC) had 
entered into force in 2005; the EU, as well as its member States, were parties to the FCTC, and committed to implement it in their legal fram eworks. There had been repeated calls from 
numerous EU stakeholders, as well as the European Parliament and Council, to strengthen tobacco 
legislation in line with these developments. At the same time, the EU was not only the world's leading importer of raw tobacco, but also the la rgest exporter of tobacco products. Growing and 
manufacturing of tobacco was an activity that, while decreasing in importance, still employed 
thousands of people in the EU. Social aspects were also duly considered, as well as the economic costs of tobacco addiction for private businesses and for the State. The European Commission had carefully balanced the need to put in place a comprehensive tobacco control policy, including the 
implementation of FCTC commitments, with economic  and trade considerations, on the basis of the 
Commission's assessment of the specific circumstances prevailing in the EU. Consistency with international rules had been ensured, including with regard to WTO provisions. The proposal was 
therefore the result of thorough consultations and in-depth analysis, and provided for a broad 
range of measures which were both non-discriminatory and proportionate to the legitimate health objectives pursued. The draft Directive was fully consistent with the EU's international 
commitments, including its obligations under the TBT Agreement, and throughout the legislative 
process, WTO aspects would be duly be taken into account.  
2.78.  The proposal 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 awareness of tobacco risks, reduce 
the appeal and attractiveness of tobacco products, and therefore contributed to a decrease in smoking rates and smoking initiation, particularly among youngsters. While the overall number of 
smokers in the EU had decreased in past decades, a significant number of EU Member States have 
witnessed an upward trend since 2008. At present, 28% of EU citizens were smokers, 70% of which had started before the age of 18. Tobacco consumption was the single most important 
avoidable health threat for EU citizens, and was responsible for 700,000 deaths each year in the 
EU. The Commission developed the new proposal ov er a long period of time, carefully balancing 
the interests of all stakeholders, and providing numerous consultation opportunities along the way. For instance, a public consultation, held in 2010, garnered over 85,000 submissions, while 
targeted discussions with stakeholders – such as consumer groups, non-governmental 
organizations, as well as tobacco growers, distributors, upstream suppliers, manufacturers, and pharmaceutical companies – had taken place throug hout the legislative development process. The 
impact assessment underpinning the Commission's proposal was also a very comprehensive 
exercise – for instance, several external studies had been commissioned to provide input into the Commission's own assessment, which had been complemented by two additional opinions by the 
EU's independent Committee on Emerging and Ne wly Identified Health Risks, on smokeless 
tobacco and, respectively, on additives.  
2.79.  The new proposal covered several policy areas, including ingredients, packaging and 
labelling, traceability, novel tobacco products, and cross-border distance sales. In the area of 
ingredients, the Commission had proposed a ban on cigarettes, "roll-your-own" and smokeless 
tobacco products with a characterizing flavour (in other words, a distinguishable aroma or taste other than tobacco, such as fruit, herb, candy, menthol or vanilla). The use of additives which 
were essential for the manufacture of tobacco products was not prohibited, as long as those 
additives did not result in a product with a characterizing flavour. As regards labelling and packaging, the proposal foresaw a mandatory comb ined warning (picture + text message) on 75% 
of the two main surfaces of cigarettes and "roll-your-own" products, as well as a ban on 
promotional and misleading elements. The proposal did not set limits on the use of trademarks or 
branding on the remainder of the pack – in other words, it did not mandate cigarettes to be sold in plain packaging. With regard to the concerns ex pressed by some delegates on the treatment of 
cigars, the she explained that that all tobacco products, including cigars, were covered by the 
p r o p o s e d  D i r e c t i v e ,  a s  w e l l  a s  u n d e r  t h e  c u r r e nt Tobacco Products Directive. However - unlike 
cigarettes and "roll-your-own" tobacco products, which accounted for over 95% of the tobacco 
market and were generally the products of choice for young people - cigars were considered niche 
products, which accounted for a fraction of the market and did not contribute to smoking initiation. Therefore, to ensure proportionality and avoid unnecessary burdens for SMEs both in the EU and 
abroad, the proposal placed less stringent requirements on these products – for instance, they did 
not have to display picture warnings, and cigars with characterizing flavours would not be banned. G/TBT/M/59 
 
- 16 - 
 
  2.80.  With respect to process, the representative  of the EU explained that the proposal would now 
go through the EU's legislative process, in whic h both the Council of the EU and the European 
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 EU 
was confident that the information provided in this meeting had been helpful in clarifying the context and various aspects of the proposal, and remained open to address any remaining 
questions bilaterally. The EU also invited Members to provide their comments in writing to the TBT 
notification by the deadline of 18 April 2013.  
2.2.1.12  Ecuador - Draft Technical Regula tion of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 080: "Labelling of  footwear" (G/TBT/N/ECU/94) (IMS ID 
378) 
2.81.  The representative of Colombia thanked Ecuador for responding to Colombia's written 
comments on this draft measure. However, his delega tion still had some questions, particularly the 
requirement for third-party conformity certificates for the labelling of footwear, which normally 
was a requirement found in technical regulations. Colombia requested more information on this requirement, including on how it related with Andean Community rules. 
2.82.  The representative of Ecuador informed that he would respond this concern together with 
the subsequent concern, also raised by Colombia. 
2.2.1.13  Ecuador - Labelling of articles of  apparel, household linen and clothing 
accessories (G/TBT/N/ECU/7, G/TBT/N/ECU/7/Add.1 G/TBT/ N/ECU/7/Add.2) (IMS ID 
379) 
2.83.  The representative of Colombia thanked Ecuador for responding to Colombia's written 
comments on this draft measures. Like the pr evious concern, Colombia requested more 
information on the requirement for third-party conformity certificates for the labelling of the 
products covered by this draft measure. 
2.84.  Replying to both concerns raised by Colombia, the representative of Ecuador expressed his 
delegation's concern that discussing this draft measure at the present TBT meeting was premature 
given that these drafts were still in the consulta tion phase, in accordance to the TBT Agreement 
and that responses had already been  sent to Colombia on 4 March. 
2.2.2  Previously Raised Specific Trade Concerns 
2.2.2.1.1  European Union - Registration, Ev aluation, Authorization and Restriction of 
Chemicals (REACH)5 (IMS ID 88) 
2.85.  The representatives of India, Australia and the Philippines reiterated concerns expressed at 
past meetings with respect to REACH. The representative of India, in particular, recalled the 
REACH Regulation's second deadline this year, and listed 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 
(SMEs); the cost associated with hiring an Only Representative (OR); and the request for merchant importers to directly undertake registration.  
2.86.  The representative of the European Union recalled replies to these questions provided at 
previous meetings. She informed Members that the Commission report on the review of REACH, 
adopted on 5 February 2013, had confirmed that it  was functioning well, but also identified the 
need to reduce its impact on small and medium -sized enterprises (SMEs). In view of the new 
registration deadline of 31 May 2013, all substances manufactured or imported at, or above, 100 
tonnes per year, would have to be registered. She referred to efforts made by the European 
                                               
5 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; and, G/TBT/W/208. G/TBT/M/59 
 
- 17 - 
 
  Chemicals Agency (ECHA) and the European Commi ssion to inform companies about their REACH 
obligations. ECHA had been offering a series of activities, including conferences, workshops, webinars and other training opportunities such as a workshop on the functioning of SIEFs and data 
sharing industries.  
2.2.2.1.2  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) 
2.87.  The representative of Japan enquired about the present status of Clause 10.2 of the revised 
"Agreement for the Grant of BIS Licence" (hereaft er BIS Agreement) that required only foreign 
tyre manufacturers to provide a bank guarantee fee of USD10,000. This clause appeared to reflect discrimination between Indian and foreign tyre manufacturers; it unfairly modified conditions of competition – it needed to be corrected so as to apply the same conditions to Indian and foreign 
companies. Furthermore, Japan called for a revision of the ISI Marking Fee calculation method that 
was calculated according to the total number of ISI marked tyres, including tyres destined for 
export from the Indian market. Japan was of the vi ew that these tyres should be exempted as the 
Indian Government need not guarantee the qua lity of products sold outside of India.  
2.88.  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 for tyres, including the requirement regarding the 
bank guarantee of USD10,000 for the payment of roya lty fees (contained in Article 10.2 of the BIS 
Agreement) and whether this was applied in the same way to domestic and foreign producers. She reiterated particular concern about the royalty fees to be paid on the total production of tyres 
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, as they were extremely burdensome and more trade-
restrictive than necessary in their current formulation.  
2.89.  The representative of Korea reiterated co ncerns regarding marking fees. He said that the 
manner in which marking fees were calculated – on the basis of the total number of tyres 
produced and marked with the ISI symbol – was unfair and needed to be reviewed; it needed to 
reflect the total number of ISI-marked tyres impo r t e d  t o  I n d i a .  C o m p a r e d  w i t h  s i m i l a r  m a r k s  
issued by other countries, fees were considerably  higher for the ISI system, and in general most 
countries did not charge marking fees for tyres.  Korea requested India to repeal the USD10,000-
Performance Bank Guarantee that was only required for foreign manufacturers outside India. He 
cited Article 5.1.1 of the TBT Agreement, stipul ating that conformity assessment procedures be 
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 originating in any other country. 
2.90.  The representative of India reiterated that  the marking fee and overall fees were equitable, 
in terms of the unit costs of tyres for both domestic and foreign manufacturers. The overall fee 
charged by India was comparable or even lower than those charged by other Members for similar 
schemes. The bank guarantee clause (Article 10.2)  under the Foreign Manufacturers Certification 
Scheme (FMCS) had been inserted to obviate any legal complications that might arise out of 
deletion of Article 6.3 of the BIS agreement th at had been removed at the request of some 
delegations. 
2.2.2.1.3  India – Mandatory Certificatio n 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) 
2.91.  The representative of the European Union voiced concerns in view of the entry into force on 
31 March 2013 – for certain steel products – of India's mandatory third party certification under 
the Steel and Steel Quality Products Order. The EU enquired about the implementation of 
mandatory third party certification, given that the European industry continued to report significant difficulties during the certification procedure, including long delays for issuing certificates, extensive and detailed information to be provided, the lack of feedback on reasons for 
refusal of applications, and the lack of recognition of test results carried out by foreign 
laboratories. The EU invited India again to take measures to ensure equal treatment for domestic and foreign manufacturers. She called on India to  institute a more expeditious procedure for the 
steel products submitted to third party certification including clear deadlines and possibilities to G/TBT/M/59 
 
- 18 - 
 
  challenge the refusal of the application. The representative asked India to consider suspending 
implementation beyond 31 March 2013 to allow already submitted applications to be processed. She reiterated the EU view that third party certification was inappropriate and too burdensome for intermediate steel producers. 
2.92.  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, and the objective of securing consumer's health safety should be 
achieved by safety regulations for final products. Second, Japan restated concerns about the 
undefined scope of the technical regulation, and as ked India to clarify the covered products. If put 
into effect as scheduled, this would create unne cessary obstacles for customs procedures, disrupt 
Japanese high-quality steel supply, and could cause a negative impact on the Indian 
manufacturing sector. Japan asked India to postpone the commencement of operation and 
implementation of the regulation until its scope of application was clarified.  
2.93.  The representative of the China also reiter ated previously stated concerns related to this 
measure, and asked in particular for a clarification on the scope of products subject to the 
certification scheme.  
2.94.  The representative of India reiterated that the regulation on nine steel products, initially 
subject to mandatory BIS certification under the quality order of 2012, had been amended on 
February 15 leading to the situation where the date of entry into force for some of these products 
had been extended from 12 September to 31 March 2013. In terms of product coverage (the nine steel products covered) the HS codes, titles and Indian standard numbers had been provided. 
Regarding the measure's applicability to intermediate products, it was noted that the regulation 
applied to intermediate products because this affected the performance of the final product.  
2.2.2.1.4  United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518, G/TBT/N/USA/518/A dd.1, G/TBT/N/USA/518/Add.1/Corr.1) 
(IMS ID 262) 
2.95.  The representative of the European Union welcomed the second addendum to notification 
G/TBT/N/USA/518 of 16 January 2013, which indi cated that the 2013-2014 ICAO Technical 
Instructions had now been implemented by the US. The EU sought confirmation that a shipment of lithium batteries in compliance with the 2013-2014 ICAO Technical Instructions could be transported to the US without any further unilatera l requirements. Moreover, with regard to the US 
second addendum on whether to provide shippers and carriers with the flexibility to choose the 
most appropriate method of compliance for the transportation of lithium batteries, her delegation enquired on requirements that could possibly be imposed by shippers and carriers other than the 
ones laid down in the 2013-2014 ICAO Technical Instructions.  
2.96.  The representative of the United Stat es recalled that, as of 7 January 2013, the US 
regulations authorized the use of the 2013-2014 ICAO  Technical Instructions for transportation of 
hazardous materials to, from, or within the US as an alternative to the US Hazardous Materials 
Regulations (HMR). Lithium batteries prepared in  accordance with the 2013-2014 ICAO Technical 
Instructions could be offered, accepted and transported. Specific to lithium batteries, a difference from the ICAO Technical Instructions (USG 2) was maintained in that lithium metal batteries 
(UN3090) were forbidden for transport aboard passenger carrying aircraft. Apart from this 
exception, the provisions contained in the 2013- 2014 ICAO Technical Instructions applicable to 
lithium batteries were in most cases more stringent than the current HMR. On 11 January 2013, 
the US had notified WTO Members that PHMSA
6 had issued a Notice of Proposed Rulemaking 
soliciting additional comments on the positive or negative impacts of adopting the 2013-2014 
ICAO lithium battery provisions. PHMSA was currently evaluating the impacts of amending the 
appropriate sections of the HMR consistent with the 2013-2014 ICAO Technical Instructions, 
which, if adopted, would have the practical effect of enacting the ICAO Technical Instructions for domestic transport of lithium batteries. No amendments more restrictive than the current ICAO Technical Instructions were being considered. 
                                               
6 Pipeline and Hazardous Mate rials Safety Administration. G/TBT/M/59 
 
- 19 - 
 
  2.2.2.1.5  Turkey – Conformity Assessment Procedures for Pharmaceuticals, Circular 
issued by the Directorate Gene ral of Drugs and Pharmacy of  the Ministry of Health re 
"Important Announcement regarding GMP Certificates" (IMS ID 264) 
2.97.  The representative of the United States reca lled previously raised concerns on this issue in 
2010, 2011, and 2012. The US thanked Turkey for alleviating the growing backlog of inspections 
by allowing for a parallel submission process. She referred to her delegation's request for additional steps to be taken by Turkey to addre ss the backlog, such as as the recognition of GMP 
(Good Manufacturing Practices) inspections cond ucted by FDA or other members of the PIC/S 
(Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme), as well as opportunities to discuss the trade concerns in more detail and to establish targets for reducing inspection delays.  
2.98.  The representative of Turkey said that Turkey's GMP certification process for 
pharmaceuticals had been explained in detail during previous meetings. He said that there was no 
comparative numerical data proving that backlogs  claimed to occur during the GMP certification 
process in Turkey exceeded those in other WTO Members. Nonetheless, he informed the 
Committee that the Turkish Ministry of Health (MOH) was working on a method that would enable simultaneous acceptance of GMP inspection and license applications. He said that Turkey was 
ready to work constructively with interested Members.  
2.2.2.1.6  Brazil - Health Products Good Ma nufacturing Practices (GMP) Requirements 
for Health Products (G/TBT/N/BRA/328) (IMS ID 233) 
2.99.  The representative of the United States reca lled previously raised concerns on this issue in 
2010, 2011, and 2012. She noted the National Health  Surveillance Agency's (ANVISA) work with 
other regulatory agencies such as the US FDA (F ood and Drug Administration) to develop a single 
auditing programme to help address the backlog through work-sharing and developing criteria for 
accreditation of third parties that would be implemented in 2014. As the inspection backlog 
continued to grow, her delegation had requested that ANVISA work with trading partners to develop interim steps. Recently, the US had noted that ANVISA had developed and published a 
strategy for 2013-2016 expanding its focus from health, safety, and cost effectiveness to also 
considering domestic market and industry impact for suppliers for medical products. She requested further information on this proposed change and voiced concerns about the potential impact on trade. 
2.100.  The representative of the European Unio n asked Brazil to provide an update on the 
situation as regards the Good Manufacturing Practices (GMP) inspections for medical devices and 
noted that a number of measures had been taken to accelerate inspection capacity. The EU asked 
if those measures were reflected in a concrete reduction of the backlog and if ANVISA was now in 
a position to guarantee that inspections were carried out within three months after the request had been filed. In case reasonable inspection deadlines could not be complied with, the EU invited 
ANVISA anew to rely on and take into account quality management system audits conducted by 
accredited auditing bodies such as EU Notified Bodies, and to consider accepting products authorised in the EU or in other major markets,  pending the completion of ANVISA inspections. 
She invited ANVISA to consider subcontracting overseas inspections to accredited auditing bodies 
such as EU Notified Bodies, which would inspect EU facilities on behalf of ANVISA and allow for a 
reduction of the current backlog. The EU enquired  if Brazil was considering these suggestions. 
2.101.  The representative of Brazil said that several measures had been adopted to improve the 
inspection capacity of ANVISA, such as the augmentation in the number of GMP inspectors. 
Measures included the relocation of experts fr om other areas of the agency, the enabling of 
experts from state and/or municipal level to act as international inspectors, and the publication of 
draft resolution No. 2 of 8 January 2013, still under public consultation, which aimed at, inter alia , 
optimising conditions for the concession of GMP certificates. To his knowledge, there had been no case of interruption of trade caused by the proce ssing of GMP certification. He recalled that Brazil 
had joined the International Medical Device Regulators Forum (IMDRF). Brazil had taken note of 
the suggestions made by the EU with a view to finding a temporary solution – but these did not 
seem feasible in the context of the legal framework of Brazil, which required GMP certificates to be issued by ANVISA. In this sense, the representati ve of Brazil invited the EU and other Members to 
consider an alternative previously suggested by  Brazil: the confidentiality agreements between 
health agencies in Brazil and other Members to exchange inspection reports. G/TBT/M/59 
 
- 20 - 
 
  2.2.2.1.7  European Union - Directive 20 04/24/EC on Traditional Herbal Medicinal 
Products (THMP) (IMS ID 265) 
2.102.  The representative of India said that despite repeatedly raising this issue in past 
Committee meetings, it remained unresolved. He briefly restated his delegations core concerns, 
including: non-notification to the WTO; the need for review of the Common Technical Document 
(CTD), which was not appropriate for multi-component traditional medicinal formulations; expansion of the definition of herbal medicinal products to include non-herbal biological and non-
biological ingredients; and the need for references to national pharmacopeia for all compliances on 
specification. Due to impediments in the Directive, India had hardly undertaken any exports under the scheme. 
2.103.  The representative of the European Union noted that extensive technical clarifications had 
been provided in previous meetings of the Co mmittee. She reported that a number of meetings 
between EU and Indian experts had been held, nota bly to discuss: issues of eligibility criteria, 
scope of the Directive, registration procedures and documentation to be provided. Her delegation 
remained open to discuss any further issues bilaterally at expert level.  
2.2.2.1.8  India – Telecommunications Related Rules (IMS ID 274) 2.104.  The representative of the United States noted improvements in India's telecommunications 
related regulations, such as the May 2011 amendment that removed the source escrow 
requirement. However, she raised three concerns: (1) the requirement for telecommunications equipment vendors to test all imported network elements in India; (2) the requirement to allow the telecommunications 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 (3) the imposition of  strict liability and possible blacklisting of a 
vendor for taking inadequate precautionary securi ty measures. The US also reiterated concerns 
with respect to the requirement that foreign firms bear additional costs of in-country testing, and 
with respect to the 1 April 2013 entry into force of the measures. 
2.105.  The representative the European Union echoed the concerns raised by the US. In 
particular, the representative of the EU raised co ncerns about the deadline for the entry into force 
of the measures, and for the absence of any appointed laboratory to process the testing applications. Additionally, he expressed concerns for the absence of final guidelines on the applicable standards and for the actual scope of testing, which he suggested be limited to critical 
elements only. He also reiterated the EU request to  maintain the current level of acceptance of test 
results and certificates issued by foreign laboratories approved under the Common Criteria Recognition Arrangement (CCRA). With regards to the testing methods, he reiterated the EU 
request that relevant international standards for information security be referenced in the final 
guidelines. Moreover, he requested clarification on the relationship between the draft guidelines on the certification of telecommunications equipment, which had been put out for public consultation 
in the spring of 2012, and the security clearance requirements to enter into force on 1 April 2013. 
Finally, he underlined the need for economic oper ators to rely on a predictable framework that 
provided legal certainty and allowed other adequa te planning for the marketing of products, and 
invited India to consider any measures that may be necessary in order to avoid any market 
disruption. 
2.106.  The representative of Japan was also concerned that the Indian regulation might not be in 
accordance with the CCRA, since only network elements approved by Indian certification agencies 
would be allowed in the market. He noted that India had accepted the CCRA scheme, and hoped 
India would ensure the regulations did not impede market access for foreign companies. 
2.107.  The representative of India said that ther e was no intention of not recognizing the process 
based conformance tests conducted by the laboratories under the CCRA, but that for security 
considerations, testing had to be conducted in the designated laboratories. G/TBT/M/59 
 
- 21 - 
 
  2.2.2.1.9  China – Requirements for info rmation 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) 
2.108.  The representative of the United States recalled previous statements in the Committee and 
noted China's commitment to the obligations of the TBT Agreement's Code of Good Practice, in 
particular, to the requirement for a 60-day public comment period. 
2.109.  The representative of the European Union also recalled previously raised concerns on this 
issue. He emphasized the need for increased tran sparency in the development of regulations and 
standards, including access by foreign stakeholders - that needed to be treated on equal terms as 
Chinese companies when established in China. He echoed the concerns of the US with respect to compliance with the Code of Good Practice by Chinese central government bodies in charge of 
developing the relevant standards. The EU also requested an update on the regulation on 
commercial encryption products managed by th e Office of State Commercial Cryptography 
Administration (OSCCA), on the six informatio n security standards developed by the China 
Electronic Standardisation Institute (CESI), and on the standard for radio frequency based mobile 
phone payments developed by the China National Information Technology Standardization (NITS) 
Technical Committee. The latter standard raised issues  of accessibility of the encryption algorithm, 
whose content and licensing conditions were for the OSCCA to determine. The EU representative 
requested that the algorithm be accessible fairly to all interested companies. In addition, he recalled previous concerns on the Multi-Level Protection Scheme (MLPS). Finally, the EU also raised a new concern regarding an announcement by  the People's Bank of China that all banking 
financial payment systems would need to integrate Chinese algorithms. In this respect, the OSCCA 
had published 14 standards on its website related to the implementation of this policy. He inquired whether these algorithms would be mandatory and, if so, under which conditions they would be 
available to non-Chinese information security product suppliers to the banking systems. 
2.110.  The representative of Japan echoed the concerns of the US and the EU. In particular, he 
expressed concerns over the encryption of the OSCCA regulations and the Multi-Level Protection 
Scheme (MLPS), and requested China to provide information on how to introduce these measures. 
2.111.  The representative of China reported that the regulation on commercial encryption 
products had been listed in the 2013 legislative work  plan of the State Council of China, and that it 
was being drafted in line with the Legislation Law and Rules on Formulation of Administrative Laws 
of China. She stated that OSCCA would undertake scientific evaluation and public consultation to 
ensure openness in the legislation process. She also explained that the essence of the MLPS aimed at safeguarding the information network and important information systems, to ensure national 
security, and to protect public interest. China had attached great importance to the security of 
information systems in banking, education, health care, transportation and other public utilities, 
due to their close relationship with citizen welfar e. Therefore, she explained, the importance of 
information systems was not necessarily decided by  the sensitivity of that industry, but by the 
possible damage it could cause to national securi ty, social order, economic development and the 
public interest. In addition, it was noted that these systems would only cover a very limited portion of all information systems in China. Therefore, it was very unlikely that the regulations would have 
a significant effect on international trade. China had repeatedly stated that, in terms of intellectual 
property protection and government procurement,  all enterprises within China would be treated 
equally in accordance with the non-discrimination principle of the TBT Agreement.  
2.112.  The representative of China welcomed the relevant technical suggestions from other 
foreign enterprises in developing the information security standards promulgated on 31 December 
2012 by SAC. With respect to the five standards on radio frequency based mobile payment, he 
stated that they were voluntary and that algorithm E was only a symbol for text description. As for 
the new concern of the EU regarding the 14 standa rds, the representative said she would bring 
this issue to her authorities. 
2.2.2.1.10  China – Provisions for the Ad ministration of Cosmetics Application 
Acceptance (G/TBT/N/CHN/821; G/TBT/N/CHN/937) (IMS ID 296) 
2.113.  The representative of Japan noted that more than three years had passed since this 
regulation had been published in November 2009, and that he was aware of only three 
applications for a new ingredient which had been ap proved over this period. He requested China to G/TBT/M/59 
 
- 22 - 
 
  speed up the examination and to provide more specif ic guidelines on the review process. He also 
noted that many applications for registration of new plant extracts and ferments by the Japanese industry had been rejected because safety evaluations had not been carried out on a single substance. These new ingredients, already found in  products in the Japanese market after safety 
evaluation clearance, had not caused any problems for consumer safety. Japan was of the view 
that some plant extracts and solvents could not be isolated, and that due to the nature of the isolation process, even if isolation was feasible, the isolated substance could have different 
properties from the one contained in the original substances. Therefore, he was of the view that 
the best way to evaluate the safety of such substances was to carry out testing of the substances as used in the final products. 
2.114.  Japan also raised a new concern with regard to the labelling requirement notified on 
21 December 2012. He stated that pursuant to this labelling requirement, the manufacturer's 
name, address, hygiene license number, cosmetic product approval document number, or filing 
number were required. This information was already required by AQSIQ Ordinance No. 100. 
Therefore, it appeared that the implementation of  the labelling requirement would bring a situation 
of duplicative regulations that was not necessary to fulfil the Chinese regulatory objective. 
2.115.  The representative of the European Union expressed appreciation for the constructive 
regulatory dialogue between the European Commiss ion services and China's State Food and Drug 
Administration (SFDA). She said that this dialogue had contributed to progress on a number of issues of bilateral interest. However, she also stated that the approval of new ingredients and of products with new ingredients continued to pose difficulties for European companies operating in 
China. She hoped that the SFDA's efforts to make  the registration scheme more operational would 
deliver results soon. She hoped that the on-going revision process of the Chinese Cosmetics Hygienic Management Rules would provide a more systemic solution to these issues, and bring 
Chinese legislation closer to international standards. Like Japan, the EU was concerned about 
G/TBT/N/CHN/937 which stipulated labelling requirements for cosmetics; she requested the Chinese authorities to coordinate with one another in order to ensure that there was no duplication 
or conflict between the requirements. Furthermore,  the representative considered that the three-
month period foreseen between adoption and implementation of the new rules was too short for industry to comply. The EU had submitted comments to China on this notification, and she invited 
China to provide a written reply. 
2.116.  The representative of the United States supported the comments made by Japan and the 
EU. She also encouraged China to consider approaches that were less burdensome and more 
commensurate with the risks involved in cosmetic products, such as post-market surveillance and 
internationally recognized good manufacturing practices. She requested clarity on the lists of 
approved substances SFDA had recently published and on how they related to SFDA approval requirements. 
2.117.  The representative of China noted that China had been cooperating closely with their 
trading partners in the implementation of the re gulation. She said there was a bilateral meeting 
going on in Beijing between China and the EU on this issue, and that China had provided various training and information sessions to the industry. With regards to the labelling requirement, she 
said China was processing and analysing the commen ts received by Members, and that due to the 
considerable amount of comments, the proposed date of adoption and of entry into force of the regulation might be postponed. 
2.2.2.1.11  France – Loi No. 2010-788: The National Commitment for the Environment 
(Grenelle 2 Law) (IMS ID 306) 
2.118.  The representative of India reiterated concerns about the lack of transparency and 
predictability of the Grenelle 2 Law. In particular, he expressed concerns about: the absence of a 
TBT notification; the lack of clarity on the international standard on which the measure would be based; the scope of the measure; the methodolog y for computation of the carbon footprint; the 
lack of a risk assessment analysis; and, the work on consultations carried out with developing 
countries. He also said that there was still no ISO standard on carbon footprint. G/TBT/M/59 
 
- 23 - 
 
  2.119.  The representatives of Argentina, Brazil and China echoed India's concerns. Argentina and 
China requested more information about the results and current status of the "pilot stage"; and 
Brazil requested the EU to notify the Grenelle 2 Law to the TBT Committee. 
2.120.  The representative of the European Union reiterated that the Grenelle 2 Law did not 
contain technical regulations but provided only for an experiment concerning environmental 
labelling. She invited concerned Members to refer to  the minutes of previous meetings with regard 
to the objective and scope of the experiment. She also said that the results of the experiment 
would be shared once evaluated. 
2.2.2.1.12  Indonesia - Technical Guidelines for 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) 
2.121.  The representative of the United States expressed appreciation for the discussion on the 
issue that had taken place at the November meet ing, but noted that the US industry was still 
seeking clarifications from Indonesia on a numbe r of issues, including whether the decree would 
only apply to products placed on the market or imported after the date of entry into force. She 
requested a written response and a delay on the adoption of the toy safety certification 
programme until the specific testing requirements were clarified. 
2.122.  The representative of the European Unio n also expressed appreciation for the discussions 
in November 2012 but noted that no progress had been made in finalizing the technical guidelines 
for implementation, which were supposed to clarify how compliance with the mandatory SNI toy 
safety standards had to be demonstrated by manufacturers (e.g. testing methods, sampling 
procedures, etc.). He also stated that no labora tory had been appointed, and urged Indonesia to 
consider postponing the entry into force and to allow further discussion with foreign industry. The 
EU also raised concerns about the level of acceptance of test reports issued by foreign 
laboratories, the modalities for the affixing of the marking of compliance, the validity of the certificates of compliance, and the acceptance of ISO 9001 certificates as proof of compliance with 
Indonesia’s Quality Management System requirements. 
2.123.  The representative of Indonesia informed the Committee that inputs from all Members had 
been consolidated by the Ministry, and that information on the requirements for azo dyes, 
formaldehyde and phthalates, as well as information on the certifications, would be accommodated 
in the technical guidance for the implementation of the ministerial decree, which was being 
drafted. 
2.2.2.1.13  Russian Federation – Draft Technical Regulation of the Customs Union on 
alcoholic products safety (G/TBT/N/RUS/2)7 (IMS ID 332) 
2.124.  The representative of the United States no ted that the notification of the Eurasian Customs 
Union's Technical Regulation on Alcohol Product Sa fety designated a date for the comment period 
which occurred a year prior to the notification. She underlined the importance of the consultation 
process in transparency commitments to the WTO and recalled that this included a reasonable 
comment period. The US was also concerned about the technical regulation itself, including with respect to the requirement that whiskies be aged for three years and that alcoholic beverages had 
to indicate an expiration date. She explained that  these requirements would have an impact on US 
producers and asked Russia to reconsider them.  
2.125.  The US understood that Russia, along with the other Eurasian Customs Union members, 
was revising the alcoholic beverages technical regulation – and that this revision required a 
circulation registry procedure for alcoholic beverages. She recalled that on 30 December 2012 Russia had signed Amendment SF171 (via the passa ge of Amendments to the State Regulation 
Law for Alcohol #286-FZ) into Russian Federal law, which created an additional circulation 
procedure outside of the Custom Union. She said that this additional circulation procedure under 
law SF 171 appeared to be duplicative to the circulation procedure in the draft Customs Union 
                                               
7 Listed as " Russian Federation – Draft on Technical Regulation of Alcohol Drinks Safety (published on 
24 October) Eurasian Customs Union Technical Regula tion on the Safety of Alcoholic Beverages)" in 
JOB/TBT/45. G/TBT/M/59 
 
- 24 - 
 
  Technical Regulation. Moreover, the circulation procedures appeared to be additional to other 
numerous and duplicative registration requirements  for alcoholic beverages, which included State 
Registration and a Declaration of Conformity. As the regulation was scheduled to go into effect on 1 March 2013, the US requested Russia to post pone the implementation of SF171 – that the 
process be clarified, and, where possible, streamli ned in the next draft technical regulation. The US 
looked forwards to receiving replies to comments sent in December 2011 and on 13 February 2013. 
2.126.  The representative of Australia acknowledged the Russian Federation's efforts to establish 
technical regulations for alcoholic products that ensured free circulation of these products in the 
single market of the Customs Union. He emphasized that Australia and Russia shared a commitment to adopt internationally accepted standards for alcoholic products as set out by the 
International Organisation of Vine and Wine (OIV) which helped to avoid the creation of 
unnecessary obstacles to trade in wine. Australia appreciated Russia's decision to notify to the TBT Committee its technical regulation on the safety of alcoholic products. On 6 February 2013, 
Australia had submitted comments on the notification of Russia's technical regulation on the safety 
of alcoholic products.  
2.127.  First, on the regulation of the use of addi tives, the representative of Australia said that a 
number of commonly used additives and processing  aids, as set out by the OIV, which did not 
affect the safety of the alcoholic product, would either have restrictions placed on their use or would not be permitted for use in wines sold in the Customs Union in accordance with Russia's technical regulation. Second, Australia underlined that restricting the use of – or banning – these 
oenological practices would limit Australia's ability to continue to provide quality wine to the 
Customs Union. Third, in the light of this, Aust ralia suggested that Russia consider adopting the 
OIV list of approved additives and processing aids , as set out in the "International Oenological 
Codex" and the "International Code of Oenological Practices". In addition, Australia sought 
clarification about the legal status of wines which conformed to the health warning statement under the previous legislation, and were in circulat ion at the time the draft regulation entered into 
force. If such wines were to be affected, he suggested that Russia would introduce a six-month 
transition period for these products to enable industry sufficient time to implement the stated labelling requirements. Finally, Australia asked that the requirement for nominated storage conditions be removed from the draft technical regulation, noting that the storage conditions of a 
wine did not affect health and safety. The representative concluded by welcoming Russia's 
consideration of these comments and those of  other WTO Members and looked forward to 
receiving a written response to its comments. 
2.128.  The representative of the European Union expressed her delegation's concerns regarding 
the procedure of notification of alcoholic products. The information that would be requested for this 
procedure was duplicative as regards the inform ation that was already provided to Russian 
authorities to fulfil requirements linked to other administrative procedures such as the 'state 
registration', the 'declaration of compliance', the system for 'excise stamps' and the 'customs 
clearance'. In addition, she noted that the circulat ion of alcoholic beverages would be allowed only 
after the reception of a notification by an authoriz ed body of a member of the Customs Union. This 
amounted to a prior authorization for the release of the products on the market with no added 
value for health and safety. Therefore, the EU requ ested the withdrawal of the notification system 
from the draft technical regulation.  
2.129.  The EU requested confirmation that the production control procedures and conformity 
assessment procedures suggested in the draft technical regulation would not be applicable to EU production sites as those had already been subjected to production controls by EU authorities. 
Third, she stated that the labelling requirements  were excessive and in some cases could mislead 
the consumer. For instance, the size and content of the health warnings and the requirement to indicate date of bottling or storing conditions for all types of drinks could be problematic. Regarding wines, she furthermore noted that according to the draft text, the use of 'concentrated 
must' and 'concentrated rectified must' was banne d in wine production for all types of wines 
except for so-called "table wines". As many EU quality wines were enriched with 'concentrated must' or 'rectified concentrated must', they would need to be classified as 'table wines' when 
exported to Russia. This was a designation with a certain depreciative connotation. This was valid 
for the ban on enrichment with sucrose for all wines including wines with geographical indication and "table wines". This would exclude a large number of EU wines from the Russian market unless 
they were labelled as "wine drinks". She noted that  enrichment with concentrated must or rectified G/TBT/M/59 
 
- 25 - 
 
  concentrated must or sucrose was an oenological practice that was widely accepted at 
international level.  
2.130.  In addition, the EU noted that according to the draft, wines with protected geographical 
indications and with protected designation of origin  would have to be bottled at their origin. Russia 
was recommended to take a more flexible approach as regards bottling of wines with protected 
geographical indications or protected designation of origin and spirit drinks with geographical 
i n d i c a t i o n  a s  s o m e  o f  t h e m  w e r e  t r a n s p o r t e d  i n  b u l k  a n d  w e r e  b o t t l e d  a t  t h e  c o u n t r y  o f  
destination. Moreover, regarding beers, while the EU welcomed the decrease of the compulsory 
malt content from 80% to 50% which was more in line with international practices, Russia was requested to remove the limit on sugar content of beers to allow for the use of fruits in beers, and to clarify if the use of additives was allowed. Furthermore, there were a number of alcoholic drink 
definitions missing in the draft or requiring adap tations such as vodka, gin, liqueur, brandy and 
vermouth. The EU had made concrete proposals for those definitions and stood ready to cooperate with Russia at a technical level. The EU also asked Russia to take measures to adequately protect 
EU geographical indications such as 'Cognac', 'Calvados' and 'Champagne' in accordance with WTO 
TRIPS rules. Finally, the representative of the EU recommended that Russia removed the ban on PET packaging from the draft technical regulation. She hoped that the concerns and suggestions of 
the EU would be taken into account before the final technical regulation on alcoholic drinks was 
adopted. 
2.131.  The representative of Mexico endorsed the comments made by the US, Australia and the 
EU. It was noted that despite exchanges of inform ation with the Russian authorities, many of the 
concerns had not been taken into account by Russia in the draft regulation. Mexico asked Russia to 
clarify a number of points, including: to provide information regarding the category for tequila and mescal when entering the Customs Union; clar ify the way in which one could register a 
denomination of origin; whether drinks could be bottled with the name of the category to which 
they belonged followed by the specific name of the product; and, whether manufacturers would have to register their products in each country. 
2.132.  In addition Mexico was of the view that  the procedure for certification appeared to be 
incompatible with Art. 5.1.2 of the TBT Agreement.  With respect to labelling, Mexico noted that 
certain requirements to specify information on labels were very restrictive, in particular the requirement to present a sentence "excess consumption of alcohol is harmful to health", which 
covered 20% of the surface area of the label. Mexico had also questioned the requirement to 
include the amount of methanol alcohol as well as the total amount of alcohol, which could create confusion for consumers. She said that during m eetings of the working group on tequila between 
Mexico and Russia, held in August 2011, Mexico had asked Russia to take into account the physical 
chemical aspects of standard 0075 2005 for alcoho lic beverages in particular - as well the Mezcal 
57SFI 94 standard. Mexico had requested that the levels of methanol be adapted to bring them 
into line with the tequila and mezcal standards. Finally, Mexico appreciated Russia's withdrawal of 
the definitions of tequila and mezcal from the draft document. 
2.133.  The representative of Argentina explained that competent authorities in Argentina were 
still looking at measures which remained of concern, particularly with respect to the lack of 
transparency (notification). In accordance with the statements made by the US, he noted that the 
time period given for comments by Russia had al ready expired when the notification of the 
measure had taken place. A period should have been given for Members to provide their 
comments. He also underlined that it was important to respect the standards set by relevant 
international bodies, for example with respect to the use of concentrated must and concentrated 
rectified must in wine production. 
2.134.  The representative of New Zealand associated his delegation with the comments made by 
others and noted that comments had been submitted directly to Russia. He noted that the 
notification procedure did not appear to provide authorities with any additional information that 
could enhance consumer safety but rather duplicated requirements already found elsewhere. For 
instance, separate conformity declarations and cert ification steps were already provided for in the 
regulations, as was a list of information points to be specified on labels and shipments. He therefore suggested that the notification proc edure be reviewed and duplicative elements 
removed. G/TBT/M/59 
 
- 26 - 
 
  2.135.  The represen tative of the Russian Fede ration explained that th e draft was still undergoing 
inter-governmental procedures that had not yet been  completed. As indicated in the notification of 
the draft, a public hearing had been completed in December 2011, but, at that time, Russia was not a WTO Member. Nevertheless, interested parties had been able to provide their comments 
within a period of 60 days. He further noted that a number of WTO Members did provide Russia 
with their comments on the draft technical regulation, and, in addition, Russia had held a series of bilateral consultations, some of which had resulted in solutions covering many issues. In February 
2013, Russia had received additional comments from the US and New Zealand which would be 
examined. He also explained that comments provided by the EU would also be taken into account when received. Finally, he reiterated Russia's willingness to be engaged in bilateral consultations with interested WTO Members, including detailed consultations among technical experts in 
Moscow.  
2.2.2.1.14  European Union - Directive 2009/28/EC, Renewable Energy Directive  
(EU - RED) (IMS ID 307) 
2.136.  The representative of Argentina reiterated concerns raised at previous meetings of the 
Committee with respect to certain specific aspects of Directive 2009/29/EC as it affected exports of 
biodiesel from Argentina to the EU. He highlighted that the Directive required compliance and 
certification with sustainability criteria and emission reduction values which had both been 
imposed unilaterally. He also stated that the default value for emission reduction of greenhouse gases in Annex V of the Directive for soya biodiesel had been established without a solid scientific basis and without consideration of technology, practices or local conditions of production in 
producing countries. He underlined that the Directive ascribed different values to each type of 
biofuel which was discriminatory as the products considered were similar. As it did not take into account the real productive practices of producing countries, it did not ensure compliance with a 
legitimate objective. Argentina had approached the EU several times and provided relevant 
technical information seeking an amendment of the value of greenhouse gas reductions provided for soya biodiesel in Annex V that reflects a specific GHG emission reduction value of soya 
produced in Argentina under the system of direct seeding. However, no progress had been made. 
He furthermore underlined that the Directive foresaw a review by the Commission, but more than three years after coming into force, there had been no such review despite the fact that the Joint Research Centre of the EU had already provided the Commission with revised values based on the 
analysis of additional information, part  of which was submitted by Argentina. 
2.137.  Regarding the requirements for certification of sustainability criteria imposed unilaterally 
by the EU, Argentina said that the EU had di scouraged recognition of the requirements and 
national systems for sustainability which were equivalent to those of the EU despite the fact that 
the Directive itself contemplate this possibility. As a result, the private sector in Argentina presented a voluntary certification scheme but its approval by the European Commission had been 
delayed. The procedure was still being analysed despite the fact that recently various voluntary 
certification schemes had been approved for EU and non-EU countries. This created a situation of uncertainty, imbalance and discriminatory treatment with respect to Argentine biofuel suppliers.  
2.138.  Argentina was also concerned about a presentation made in October 2012 by the European 
Commission to the Parliament and the Council of a proposal for amendments to Directive 2009/28 
and 98/70. He stated that the presentation did no t take into account comments by third countries 
and other actors regarding the lack of scientific evidence supporting the implementation of policies 
and actions of the so called Indirect Land Use Ch ange impacts of biofuels (ILUC). Argentina was 
concerned that the proposal contemplated that an estimation of ILUC emissions be included in the 
report of emissions. This represented a negative future signal for the biofuel industry since the 
ILUC factor could be included in the content of  emissions for 2020. The values for greenhouse gas 
emissions caused by ILUC with respect to other bi ofuels could therefore be estimated on the basis 
of theoretical models which did not take into account scientific evidence and the technologies, practices and local conditions in countries of production. Argentina requested the EU to take into 
account its comments to eliminate the uncertainty in the biofuel market and to avoid the 
implementation of measures that result in ne w unnecessary obstacles to international trade.  
2.139.  The representative of the European Union explained that these concerns fell outside the 
scope of the TBT Agreement. The EU therefore considered that the TBT Committee was not an 
appropriate forum for the discussion. She nonetheless stated that the EU remained open to further bilateral exchanges. G/TBT/M/59 
 
- 27 - 
 
  2.2.2.1.15  Viet Nam – Decree regulating the Implementation of Some Articles of Food 
Safety Law Decree 38 implementing th e Food Safety Law (G/TBT/N/VNM/22, 
G/TBT/N/VNM/22/Suppl.1) (IMS ID 356) 
2.140.  The representative of Australia noted that his delegation had been following the 
development of the implementing decree for Vietnam's Law on Food Safety (Decree 38) closely. 
While Australia supported Vietnam's right to implement measures to protect the health of its consumers, it was important that such measures were no more trade restrictive than necessary. 
He noted that Decree 38 had formally entered into force on 11 June 2012 but that there was a lack 
of clarity as to how Decree 38 would operate. Australia encouraged Vietnam to delay full implementation of Decree 38 until the arrangements for implementation had been fully considered 
and clearly communicated to trading partners. He explained that Australia appreciated Vietnam's 
notification and encouraged Vietnam to continue to notify the WTO of any technical circulars 
guiding the operation of the Law on Food Safety. Australia looked forward to working constructively with Vietnam to ensure trade was not disrupted. 
2.141.  The representative of the European Union recalled concerns about the measure at issue. 
She noted that Vietnam's notification had been issued seven months after the adoption of the 
Decree, and six months after its implementation. The EU therefore continued to urge Vietnam to 
suspend the application of the Decree until concerns of WTO Members had been adequately 
addressed, and producers had sufficient time to comply with the requirements. She also reiterated concerns on the complexity and unnecessary burden that this Decree would cause due to the multiple declarations of conformity and related do cuments that had to be submitted to Vietnamese 
authorities prior to importation, as well as the number of different ministries involved. The EU 
remained concerned about the impact of this Decr ee on imports into Vietnam, due to the lack of 
clarity on the applicable requirements, scope of products covered, and authorities responsible for 
implementation.  
2.142.  The EU also wished to point at some specific concerns; for instance, the difference 
between 'expiry date' and 'use by' date, the overly  prescriptive requirement that the font of the 
name of the product be at least 3 times that of the other information on the label, or the labelling 
requirements for 'functional foods' and 'foods en riched with micronutrients'. Furthermore, the 
requirement to provide notarized copies (or copies  legalized by the Vietnamese consulate) of the 
conformity assessment documentation was also of concern. The EU asked Vietnam to eliminate 
this requirement, which significantly increased compliance costs without having any positive 
impact on food safety. She also underlined that the EU had submitted comments to Vietnam under the TBT notification procedure on 25 February 2013 , and that the EU looked forward to Vietnam's 
reply.  
2.143.  The representative of New Zealand endors ed the statements made by Australia and the 
EU. Given his delegation's requests at previous meetings to notify implementing circulars, he 
thanked Viet Nam for notifying to Members the draft circular regulating state control of food safety 
within responsibility and authority of the ministry of industry and trade G/TBT/N/VNM/23 which would give effect to part of Decree 38. He explained that New Zealand would submit comments on this draft through the appropriate channels. He encouraged Viet Nam to notify the Members all 
other draft circulars and instruments.  
2.144.  The representative of Viet Nam stated that before being notified in accordance with the 
TBT Agreement, draft Decree 38 had been notified to the SPS Committee on 25 March 2011 
(G/SPS/N/VNM/27) and the final adopted decree had been notified on 11 May 2012 
(G/SPS/N/VNM/27/Add.1). At the request of several Members, Viet Nam had notified the Decree to the TBT Committee in November 2012 under Article 2.10.1 and comments received would be 
considered and replied to as soon as possible. 
2.2.2.1.16  European Union – Directive 2011/62/ EU 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 Medi cinal Products (IMS ID 334) 
2.145.  The representative of India raised concerns  regarding the absence of a notification of the 
implementation of the EU Directive; the definition of falsified medicine products which did not G/TBT/M/59 
 
- 28 - 
 
  include the parameters of quality, safety and effi cacy; as well as the need for an adequate time 
period for compliance for the industry sector. He noted that one of India's primary concerns which had been raised at the last TBT Committee meeting, was about the certification by Indian authorities of the GMP compliance of the EU. He explained that India believed that the EU had 
changed the format in its new regulation, and requested an update about this, and whether the 
WHO GMP equivalence would be acceptable by the EU. 
2.146.  The representative of Brazil noted that hi s delegation shared some of the concerns raised 
by other delegations on this issue and he thanked the EU delegation for having provided 
information on this matter on a bilateral basis. Brazil had applied to be included in the list of countries exempted from issuing a certificate of conformity with the EU requirements. This list 
considered Members where their regulatory framework was equivalent to those of the EU. He 
noted that Brazil was concerned that the procedures to be implemented were too restrictive and 
that the established timelines and procedures to  be followed were not sufficiently flexible.  
2.147.  The representative of the European Unio n explained that this subject had already been 
extensively discussed at previous meetings of the TBT Committee and at a bilateral level. The 
Directive provided that imported active substances had to be manufactured in accordance with Good Manufacturing Practices so as to ensure protection of public health at a level 'at least 
equivalent' to the one applied in the EU. She noted that the World Health Organisation (WHO) GMP 
guidelines for active substances were considered to be equivalent to the EU ones. To comply with the Directive's provisions, competent authorities of  exporting countries needed to issue a 'written 
confirmation' that the standards of good manufacturing practice applicable to the plant 
manufacturing the active substance were at least equivalent to those in the EU. The written 
confirmation was a simple system building on mutual trust between competent authorities worldwide. A template for the written confirmation , fully in line with the WHO-formatted API GMP 
certificate, had been shared with key trading partners. In addition, a questions-and-answers-
document had been made available for market operators and competent authorities. Some countries had now confirmed that they were ready to issue the written confirmation. Other 
countries had asked to be listed by the Commission on the list of countries for which the written 
confirmation was waived. She furthermore noted that all relevant information was publicly available and that the European Commission expe cted a smooth implementation of the rules by 
July 2013.  
2.2.2.1.17  China – Testing and Certificat ion Requirements for Medical Devices  
(IMS ID 143) 
2.148.  The representative of the European Union recalled concerns about the on-going revision of 
China's Order 276 on Medical Devices, covering, inter alia , requirements related to 
standardization, product classification and conf ormity assessment. The EU remained concerned 
about the fact that medical devices imported into  China were subject to duplicative regulatory 
controls due to the overlapping responsibiliti es of two Chinese authorities: the General 
Administration for Control Supervision, Inspection and Quarantine (AQSIQ) and the State Food and Drug Administration (SFDA) in the conformity a ssessment procedure, pre-market registration and 
re-registration. She noted that this significantly increased compliance costs for companies without 
any additional safety benefit. She asked China to clearly indicate in the Order the single  competent 
authority in China responsible for the approval of  medical devices (which should be the SFDA) and 
that any check of medical devices at the time of importation would be limited to a verification of 
the conformity assessment documentation issued in the SFDA approval procedure, without the 
need for duplicative testing, certification or inspection at the customs clearance stage.  
2.149.  The representative of the EU also stre ssed the need for greater convergence of China's 
applicable mandatory standards to international ones, as well as more flexibility in accepting 
medical devices on the Chinese market which had been made in compliance with the latest series of international standards. Furthermore, she invited China to provide a sufficient transitional period between the application of a new standard and the abolition of older standards; for example, in the 
EU, during the transitional period both versions of  the standard could be used, allowing industry to 
adapt more easily. She further requested that China provide for greater acceptance of foreign clinical trial data and foreign test results. She recalled concerns regarding the need for approval of 
the products in the country of origin or country of manufacture, or the burdensome procedures for 
re-registration.  G/TBT/M/59 
 
- 29 - 
 
  2.150.  On procedural matters, the EU understood that Chinese authorities would adopt and 
publish this order in the near future. In this regard, she highlighted the need for China to notify this comprehensive legislation to the TBT Committee and allow WTO Members a reasonable time to provide comments. She also urged China to take Members' comments into account in 
accordance with China's obligations under the TBT Agreement and its commitment to do so in the 
context of the 2012 Trade Policy Review. Moreover , the EU underlined the need for an adequate 
implementation period of at least one year, betwee n the publication of the order and its entry into 
force. She said that the EU was grateful for the good bilateral cooperation with China in this area, 
and looked forward to the upcoming meeting of the EU-China Working Group on medical devices. 
She noted that the EU hoped that these expert ex changes would lead to satisfactory solutions to 
EU industry market access problems in China. 
2.151.  The representative of Japan expressed general support for the concerns about China's 
testing and certification requirement for medical devices delivered by the EU – in particular with 
the burdensome processes. According to Japane se industry, certain tests and documents that 
would not be required in other countries were required during the process for marketing 
authorization in China; including, for example, a test which required that the actual equipment be 
at the examination center. The representative also recalled that some mandatory standards for 
medical devices, for instance the standard for CT, were unique in China and not in line with 
international standards. Thus, Japan requeste d China to harmonize the test methods and 
documents required for marketing authorization with international practices, specifically, to eliminate the unnecessary tests and documents th at were not required in other countries.  
2.152.  The representative of Japan also reiterated concerns about the need for certification for 
marketing authorization in the exporting countries. For Japanese industry, a certification for the marketing authorization in the countries of origin was required in China. Even medical devices 
solely for export needed to obtain marketing auth orization in exporting countries, even in the case 
that they were not intended to be sold in their countries of origin. Since the SFDA could evaluate 
efficacy and safety of medical devices, Japan requested China to abolish the requirement of 
certification for marketing authorization in the countries of origin. Japan was also concerned about 
the burden of renewal of registration: there wa s a requirement to renew the registration of 
medical devices every four years – this imposed a heavy burden on manufactures. Japan invited 
China to extend the renewal period. 
2.153.  The representative of the United States associated her delegation with the concerns raised 
by the EU and Japan and again noted that China had not notified the WTO of Decree 276, first 
promulgated in 2000, and then significantly amended in 2007, 2010 and again in 2012. She 
reminded China of its notification obligations an d associated her delegation with many of the 
technical difficulties found in the most recent amendment, including the problematic application of end-product type testing to ensure safety and quality of devices, as well as the burdensome 
requirements for product re-registration. She nonetheless noted that improvements had been 
made in the 2012 revisions, such as China's waiver of in-country clinical trials for Class 1 devices or the extension of registration period from 4 to 5 years. 
2.154.  The representative of Brazil thanked China for its bilateral collaboration on the margins of 
the last TBT Committee meeting which had led to greater knowledge of China's Order 276 on 
medical devices. Notwithstanding, he stressed the fa ct that the Order had not been notified to the 
TBT Committee, which had resulted in a lack of opportunity to provide comments. He invited China 
to notify this measure so that the Brazilian companies which imported medical devices to China 
could be aware and participate with valuable inputs on this issue. 
2.155.  The representative of China noted that the revision 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. During this period China had received comments from various organizations and the Legal Affairs Office of the State Council was still revising this regulation while taking into account comments received from stakeholders.  G/TBT/M/59 
 
- 30 - 
 
  2.2.2.1.18  New Zealand - Proposal to Introduc e Plain Packaging of Tobacco Products in 
New Zealand (G/TBT/N/NZL/62) (IMS ID 361) 
2.156.  The representative of the Dominican Republic expressed serious concern about the impact 
of the measures proposed by New Zealand with respect to their consistency both with the TRIPS 
and TBT Agreements. The full statem ent is contained in G/TBT/W/359. 
2.157.  The representative of Guatemala shared Ne w Zealand's public health objective of reducing 
the appeal of tobacco products and smoking, partic ularly for young people as well as discouraging 
them from smoking or using tobacco products. Guatemala was nevertheless concerned with the 
proposed regulation as it was unclear how New Zealand would reconcile its obligations under the WTO Agreement with the legitimate public health objectives. Also unclear was how this measure would attain such objectives.  
2.158.  The representative of Honduras associated herself with the statements made by the 
Dominican Republic. While Honduras shared New Zealand's public health objectives, it was 
nevertheless concerned with the compatibility of the proposed measure with the obligations under 
WTO Agreements, in particular the TBT and TRIP S Agreements. Article 2. 2 of the TBT Agreement 
required all Members to ensure that technical regulations were neither drafted, adopted nor 
applied so as to create unnecessary trade barrier s. Article 12.3 of the TBT Agreement required 
Members to ensure that their technical regulations did not create unnecessary obstacles to exports 
from developing country Members. Given the disp utes currently before the DSB, Honduras hoped 
that the drafting of similar legislation would wait until the conclusions and guidance from those disputes were available. In this vein, Honduras was pleased with the statement from New 
Zealand's Prime Minister that the implementati on of its plain packaging measure would only 
commence after the final decisions of those disputes.  
2.159.  The representative of Nigeria stated that while her delegation acknowledged New 
Zealand's efforts to take appropriate measures to protect its citizens' health and welfare, it was 
nevertheless concerned with the compatibility of those measures with WTO disciplines, in particular the TBT Agreement. She asked New Zealand to provide the scientific and technical 
information demonstrating that plain packaging woul d reduce the number of smokers as well as to 
explain how the measure would comply with the Ar ticles 2.2 and 2.4 of the TBT Agreement. She 
urged New Zealand to take in account views and concerns raised by Members so as to come up with WTO-compliant alternatives. 
2.160.  The representative of Nicaragua associat ed himself with the concerns expressed by the 
Dominican Republic and other delegation. Nicaragua supported the legitimate right of New Zealand 
to adopt health measures concerning tobacco products provided that such measures were 
compatible with WTO obligations (in particular the TBT and TRIPS Agreements) as well as other 
international agreements. Since there was no scientific proof that plain packaging would influence the behaviour of consumers, or reduce tobacco consumption among young people, the adoption of 
such measures would unfairly restrict trade and would not contribute to achieving the stated 
objectives. Such measure would thus be trade restrictive and negatively impact the competitiveness of countries such as Nicaragua in international trade. In particular, New Zealand's proposed measure would undermine the economic rise of small countries like Nicaragua, which 
depend on the manufacture of tobacco products as  a key tool for poverty reduction by generating 
direct and indirect jobs. Finally, Nicaragua welcomed the fact that New Zealand's government had recently decided to wait for the ruling on the disputes currently being litigated in the WTO 
concerning tobacco before adopting or impl ementing its own plain packaging measure. 
2.161.  The representative of Kenya said that his delegation supported New Zealand's proposed 
plain packaging measure, which it considered to be  in line with Article 2.2 of the TBT Agreement, 
which stated that the protection of human and health and safety was a legitimate objective. 
2.162.  The representative of Australia stated that WTO Members had to confront the global 
tobacco epidemic. He recalled that the joint WT O-WHO-WIPO study "Promoting Access to Medical 
Technologies and Innovation", launched in February by Director General Pascal Lamy, and his 
WHO and WIPO counterparts, confirmed that tobacco  use was the second highest global risk for 
mortality in the world (behind high blood pressure) and was also responsible for the deaths of almost one in ten adults worldwide. Australia welcomed New Zealand's decision to legislate for G/TBT/M/59 
 
- 31 - 
 
  tobacco plain packaging, thus being on track to become the second country in the world to 
legislate for tobacco plain packaging. Tobacco plai n packaging was a legitimate measure, designed 
to achieve a fundamental objective: the protecti on of human health. Australia appreciated New 
Zealand's consistently strong support for Australia's measure, including in TBT Committee 
meetings. Australia looked forward to supporting New Zealand's on-going development of its own 
measure. Australia's world first tobacco plain packaging measure had now come into full effect across the country. There were already anecdotal reports indicating that the plain packaging 
measure was working. The tobacco plain packaging measure was a long term public health 
investment and the effects of the measure would be seen over the long term. He recalled that 
Australia and New Zealand were both parties to  the WHO FCTC, which recommended the adoption 
of tobacco plain packaging in the guidelines for the implementation of Articles 11 and 13 of the 
Convention. Tobacco plain packaging measures were endorsed by leading public health experts as 
well as the WHO and were supported by extensive research reports and studies. Australia was of 
the firm view that Members had the right to implement measures necessary to protect human 
health, while complying with relevant international treaty obligations. 
2.163.  The representative of Ukraine recalled that in previous meetings of this Committee her 
delegation had raised concerns about Australia's unnecessarily trade-restrictive and WTO-
inconsistent plain packaging measures that appear to violate Australia's WTO obligations. She also 
recalled that the Australian measure was currently  subject to a WTO dispute settlement challenge 
by Ukraine. New Zealand's proposed plain packaging measure was very similar to the one adopted by Australia Ukraine welcomed New Zealand's decision to wait the outcome of that dispute before 
proceeding with the adoption of its own proposed plain packaging measure. This was indeed an 
appropriate way of taking into consideration the concerns expressed by many Members in respect of Australia's plain packaging measure. In terms of the substance of the proposed measure, her 
delegation requested that New Zealand explain the evidence relied upon in its design of this 
measure. For example, how did New Zealand's evidence differ from that relied upon by Australia? Had New Zealand examined any alternative, less trade-restrictive measures that would support its 
public health goals without resulting in the removal of all trademarks and the standardization of 
the products and their packaging? If such alternatives were examined, could New Zealand indicate why such alternative measures were not preferred? Did New Zealand conduct any study addressing the likely unintended consequences of the plain packaging measure in terms of its 
impact on prices and on illicit trade? She said that Ukraine was concerned that plain packaging 
measures, like the ones adopted by Australia an d proposed by New Zealand, were more trade 
restrictive than necessary to fulfil their stated objectives and may thus be inconsistent, among 
others, with the obligation under Article 2.2 of  the TBT Agreement. Ukraine also had serious 
concerns over the lack of consistency of a pl ain packaging measure with Members' obligations 
under the TRIPS Agreement. Ukraine supported New Zealand's public health concerns, and Ukraine 
had also adopted stringent tobacco control measures that seek to effectively reduce smoking 
prevalence rates in Ukraine. However, Ukraine considered that any such measures must comply with obligations under relevant WTO Agreements, including the TBT Agreement, and should thus be lawful, appropriately effective and not disproportionate. 
2.164.  The representative of Cuba stated that her delegation had always recognized the right of 
Members to address public health problems. However, Cuba had consistently stressed its 
preoccupation with the economic impact that plain packaging measures could cause in developing 
country producers of tobacco products. The measure would affect trademarks and geographical 
indications, the value of which had been built up over many years, even centuries. Such measure 
could also have a negative impact with respect to the illegal trade of tobacco products. She 
recalled that Cuban cigars have been subject of falsification throughout the years, forcing the 
Cuban industry to develop various measures to minimize the counterfeiting of these products. These measures would be voided with the introduc tion of plain packaging. Cuba was also of the 
view that such measures would be incompatible with the TBT Agreement, in particular Article 2.1 
as well as the TRIPS Agreement, in particular its Article 20 and Article 10bis of the Paris 
Convention, as incorporated in the TRIPS Agreem ent. She also recalled that in the TBT Committee 
session of November 2012, Cuba read out and then sent in writing a series of questions to New 
Zealand asking New Zealand to show the scientifi c evidence proving the relationship between the 
measure and the specific results to be achieved for health purposes. 
2.165.  The representative of Norway stated that public health and tobacco control were topics of 
particular interest to her delegation. Each WTO Member, including New Zealand, had the right to 
adopt measures which were necessary to protect pu blic health as long as they were consistent G/TBT/M/59 
 
- 32 - 
 
  with the WTO Agreements. She noted that plain packaging of tobacco products was a 
recommended measure under the FCTC. It was Norw ay's firm opinion that the FCTC and the WTO 
agreements were mutually supportive and that it was possible to implement measures intended to 
regulate packaging of tobacco products in line with both sets of binding obligations. 
2.166.  The representative of the Philippines stated that while her delegation shared New 
Zealand's public health objectives, it also expressed interest in the issue of the relationship 
between plain packaging's public health objectives and the obligations of Members under the 
TRIPS and TBT Agreements. 
2.167.  The representative of Canada said that all Members can benefit from the information that 
New Zealand provided and its experience with plain packaging would help WTO Members gain a 
better understanding of the complex issues at stake. 
2.168.  The representative of Zimbabwe said that her delegation shared the same concerns 
expressed by the Dominican Republic and other de legations regarding the proposed measures as 
they could be incompatible with the TBT and TRIPS Agreements. She noted that Tobacco farming 
had become a major source of livelihood for many farmers in developing countries. In Zimbabwe, 
over 200,000 families rely on tobacco farming. Tobacco contributed significantly to the country's GDP and was a major export good. New Zealand's measure would therefore impact negatively on 
employment and economic performance and poverty alleviation efforts. While there was no 
scientific evident that the measures would influence the behaviour of consumers or reduce smoking amongst youth, it was evident that the measures would result in higher poverty levels and this would compound health challenges that de veloping countries already face. It was in light 
of the restrictive effect of the measures on trade and the negative impact on tobacco producing 
developing countries that Zimbabwe requeste d New Zealand to consider its concerns.  
2.169.  The representative of Uruguay stated that his delegation supported New Zealand's 
proposed measure, which simply implements the FCTC's recommendation on plain packaging 
contained in its Article 11. These plain packaging measures were not more trade restrictive than necessary to protect public health and constituted the next logical step following a ban on all 
tobacco advertising. Indeed, the packages were today the last place available for tobacco 
marketing, where trademarks and colours are used to attract consumers and distract them from the impact the health warning on these packages. In  this context, he recalled that the according to 
the 2010 "Punta del Este Declaration", measures to protect public health, including measures 
implementing the FCTC and its guidelines, fell within the power of sovereign States to regulate in 
the public interest, which includes public health. 
2.170.  The representative of the WHO restated th e information provided at the previous meeting 
of the Committee.8 She noted that in light of concerns expressed at this meeting regarding illicit 
trade in tobacco products, Members might find it useful to hear that the first Protocol to the WHO FCTC – the Protocol to Eliminate Illicit Trade in Tobacco Products 5 - was adopted recently. It was 
opened for signature on 10 January 2013 and had 14 signatories to date. 
2.171.  The representative of the Dominican Republic thanked the WHO for the information 
provided on global tobacco control efforts. Domestically, the Dominican Republic had also made 
use of various tools to convince people to spontaneously stop smoking, such as educational 
campaigns, high taxes and restrictions in public spaces. This demonstrated that there were various 
ways to restrict the use of tobacco without affecting countries' international obligations. However, the Dominican Republic could not accept any attempt to force countries to impose restrictions 
which would eliminate the application of the WT O agreements. He expressed concern with the 
double-standard professed by certain countries which in one hand promote measures banning smoking, but on the other advocate the legalizati on of the use of marijuana. Another source of 
concern was that certain international organisations were adopting positions that could become a 
new type of "inquisition" against trade. He crit icized the purported link these organizations were 
making between tobacco and illness like diabetes as well as between tobacco and poverty. He was concerned that this line of argument could easily extrapolate tobacco and be also used with 
respect to other products like alcohol, fast food or red meat. 
                                               
8 G/TBT/M/58, Paras 2.22 - 2.25. G/TBT/M/59 
 
- 33 - 
 
  2.172.  The representative of New Zealand stated that the decision to work towards the 
introduction of a plain packaging regime was taken to advance New Zealand's public health 
objectives, and followed a comprehensive and transparent public consultation process, closed on 5 October 2012, which was notified to this Committee in July last year (G/TBT/N/NZL/62). The public 
consultation process was conducted on the basis of two main documents: (i) the consultation 
document, entitled "Proposal to Introduce Plain Packaging of Tobacco Products in New Zealand", 
and (ii) the "Regulatory Impact Statement", which was a domestic legal requirement for new laws. 
Both of these documents were available on the Ne w Zealand Ministry of Health's website and links 
to them, and other relevant information, were also found in the Room Document which was available to Members during the meeting.
9 The public consultation process generated a substantial 
number of submissions from interested parties within New Zealand and around the world. The 
consultation document specifically sought the views of tobacco manufacturers and exporters, 
including those within developing countries, on th e impact of plain packaging of tobacco products. 
Several WTO Members submitted comments on the proposal, including developing countries with 
small economies.  
2.173.  He explained that the submissions received through the consultation process were used to 
inform the Government's decision to work towards the introduction of a plain packaging regime for 
tobacco products. The consultation document and the "Regulatory Impact Statement" outlined the 
Government's policy objectives and analysed the various different regulatory options to achieve 
those policy objectives. They also referenced the scientific evidence regarding the effectiveness of plain packaging and summarise the submitted views by  both thematic area and the category of the 
submitter. The Ministry of Health website also fe atured the submission that was considered by the 
New Zealand cabinet, and the minutes of the decisi on made by Ministers. He explained that this 
decision was part of a long policy development process that would continue for some time yet. This 
year New Zealand officials would commence the pr ocess of developing draft enabling legislation 
providing for a plain packaging regime. Detailed regulations to implement the regime would be developed subsequently. There would be opportunities during this process for interested parties to 
express their views on the design of the measure. New Zealand would notify this Committee at an 
appropriate time in order to facilitate such input. New Zealand considered that making all the above information freely and widely available, demonstrated its commitment to a transparent and robust process that was in full compliance with WTO obligations. 
2.174.  As to the substance of the proposed measure, he first recalled that his delegation had 
already responded to many of the points raised  on this issue at the present meeting at the 
previous meeting, in November 2012. Therefore, rather than repeating the statement made at that 
occasion, he referred Members to page 7 of the minutes of the November 2012 meeting in 
document G/TBT/M/58. New Zealand also remained ready to meet bilaterally with Members to further discuss the proposed measure, and in that regard he noted that his delegation was 
delighted to meet with Cuba just before the meeting to discuss the questions they had raised in 
their communication in G/TBT/W/356.  
2.175.  He stressed that New Zealand's decision to go ahead with this proposed measure was 
made in order to protect public health. Smoking was the single largest cause of preventable death 
and disease in New Zealand, with approximately 5,000 New Zealanders dying each year from 
smoking or exposure to second-hand smoke. In particular, New Zealand's indigenous people, the Māori, are overrepresented in all negative smoking statistics, with the prevalence of smoking 
among Māori almost double that of the general population. New Zealand was determined to 
continue tackling this tobacco epidemic, and took th erefore the negative impact on public health of 
tobacco consumption very seriously. For this reason, in 2010, the New Zealand government 
adopted the goal of making New Zealand essentially smoke free by 2025, in order to protect and 
promote public health. New Zealand believed that there was strong evidence that plain packaging, 
as part of a comprehensive tobacco control programme, would contribute to the objective of improving public health. Details of this evidence were set out in the "consultation package", and 
interested Members were encouraged to examine it. 
2.176.  Turning to issues of legal compliance, he underlined New Zealand's commitment to all its 
international obligations. In developing its policy on plain packaging, New Zealand had closely 
examined the consistency of its policy with its obligations under the WTO Agreements, including 
the TBT Agreement. New Zealand would ensure th at the development and implementation of a 
                                               
9 This document was subsequently circulated  with the symbols G/TBT/W/363; IP/C/W/586. G/TBT/M/59 
 
- 34 - 
 
  regime for plain packaging would be consistent with the obligations under the TBT Agreement and 
other relevant WTO Agreements. Additionally, implementing plain packaging measures would assist New Zealand to meet its obligations under the WHO's Framework Convention on Tobacco Control ("FCTC"), including Articles 11 and 13 of the FCTC. In this regard, he recalled that the 
Conference of the Parties to the FCTC had agr eed on guidelines for the implementation of 
Articles 11 and 13 of the FCTC and those guidelines recommend that Parties consider adopting plain packaging requirements for tobacco products. New Zealand did not think it was relevant, or 
helpful, to compare New Zealand's tobacco control measures with the regulation of other products. 
Tobacco products were unique from both a health and regulatory perspective. As the WHO had said: "tobacco is the only legal consumer product that kills up to half of those who use it as intended and recommended by the manufacturer". 
2.177.  He concluded by noting that New Zealand was a third party in three WTO challenges to 
Australia's plain packaging measures by Ukraine, Honduras and the Dominican Republic. New Zealand would continue to support Australia in its defence of plain packaging at the WTO. In 
making its decision to work towards the introduction of a plain packaging regime, the Government 
of New Zealand had noted that, if necessary, enactment of New Zealand's legislation and/or regulations could be delayed pending conclusion of the Australian cases. 
2.2.2.1.19  Israel - Warning Regulations on Alcoholic Beverages (G/TBT/N/ISR/609) 
(IMS ID 364) 
2.178.  The representative of the United States reiterated concerns regarding Israel's proposed 
changes of the placement of warning labels on co ntainers of alcoholic beverages. She especially 
expressed concerns regarding the outcome of Sect ion 2 of the draft amendment, which proposed 
to create two distinct warning labels for alcoholic beverages. In accordance with Israel's underlying law, products that contained more than 15.5% alcohol by volume would need to carry a distinct 
and stronger warning statement. She understood that this would be discussed under the new 
Knesset and requested an update on this regulation.  
2.179.  The representative of the European Union had similar concerns with the Israeli draft 
legislation on the Restriction on Advertising and Marketing Alcohol Beverages (Warning Mark) 
Regulations, 5772-2012. She underlined that the EU had submitted comments to the Israeli notification on 17
 September 2012 to which no reply had been received. She therefore reverted to 
concerns regarding this measure and requested a written reply. The EU remained concerned about 
the establishment of two different types of wa rnings for alcoholic consumption dependent on 
alcohol content. According to scientific studies, it was the excessive consumption of alcohol that 
was harmful for health, regardless of the type of  alcoholic beverage. The differentiation between 
strong intoxicating liquors and intoxicating liquors in the warning message could mislead 
consumers; they might conclude that some alcoholic beverages were more harmful than others. She thus invited the Israeli authorities to consider providing only one form of warning statement 
against excessive consumption of alcoholic beverages.  
2.180.  The EU also sought clarification about where, exactly, the warning message would have to 
be affixed and whether the Israeli authorities would accept additional labels or stickers containing 
the requested warning to be added in the distri bution phase. If the warnings and information 
would have to appear on the front label, the EU drew the attention of Israeli authorities to the fact 
that such an obligation would have a burdensome and costly impact on imports as EU producers would be obliged to produce front labels for the Israeli market only. Information for the consumer 
could be provided with less restrictive requirements; strict provisions related to the colour of the 
text or to the inclusion of a black frame did not seem justified.  
2.181.  The representative of Israel said that there was no further information to add to that that 
was provided at the previous Committee meeting and that he would send the comments made by 
the US and EU to his capital.  G/TBT/M/59 
 
- 35 - 
 
  2.2.2.1.20  European Union – Draft Commissi on Regulation implementing Directive 
2009/125/EC of the European Parliament and of the Council with regard to Ecodesign Requirements for Directional Lamps, Light emitting Diode Lamps and related Equipment 
(G/TBT/N/EU/34) (IMS ID 365) 
2.182.  The representative of China was concerne d about the EU eco-design Directive on certain 
kinds of lamps. Although appreciative for bilateral contacts, China regretted that the EU had not 
considered comments provided. For example, Chin a had asked the EU to change the number of 
samples for testing from 20 to 10 so as to reduce unnecessary burdens for the manufacturer and 
also to bring the Directive in line with current practice. He also asked for a longer transactional period for developing Members to adapt to the ne w requirements of the EU Directive. In this 
regard, he noted that in the final regulation, the original envisioned time frame had to change. He 
also underlined that his delegation had been informed  by the EU that it would revise the regulation 
no later than three years after its implementation.  
2.183.  The representative of Korea reiterated conc erns about the EU Directive. He underlined that 
the Korean Government respected the efforts of the EU and its member States to conserve energy. 
Nonetheless, Korea was particularly concerned about the requirement that specified that " the 
luminous intensity in any direction around the tube axis does not deviate by more than 25% from 
the average luminous intensity around the tube" . At the last TBT Committee, the EU had explained 
that the requirement specified that a LED tube could be claimed to be equivalent with a fluorescent tube of a particular wattage only if certain conditions were fulfilled. If the conditions were not fulfilled, the LED tube could still be placed on th e EU market, provided that the equivalence claim 
did not refer to particular wattages of fluorescent tubes.  
2.184.  In Korea's view, the claim that a LED tube was equivalent with a fluorescent tube of a 
particular wattage could have a significant impact on consumer selection of products. Considering 
the characteristics of LED tubes, which generate d a lot of heat but were influenced in their 
performance by the temperature, heat emitting f unction was essential for LED lamps. Accordingly, 
LEDs had heat sinks mounted on their upper side wh ere it did not need to emit light. However, to 
comply with the requirements of the EU directive, LEDs would need to emit light in all directions. 
As a result, this made it difficult to place a heat sink on its upper side. Consequently, this could seriously reduce the longevity of an LED tube due to its reduction of heat emitting performance. The Korean delegation was, therefore, of the opinion that it was technically difficult to comply with 
the requirement. Korea thus asked the EU to provide data on the possibility of technical 
implementation of this requirement. 
2.185.  The representative of the European Unio n thanked the Chinese and Korean delegations for 
their interest in Commission Regulation (EU) No 1194/2012, which had been adopted on 12 
December 2012 and published in the Official Jour nal of the EU on 14 December 2012. The EU did 
not consider it necessary to extend the deadline for application of Stage 2, as it considered that 
two years was enough to adapt to the new requirements. The representative informed China that 
the Commission would review the Regulation within three years in accordance with Article 7. Regarding the number of samples to be tested, she stated that 20 was the number of samples required by other EU regulations and standards already in force. She underlined that the EU 
believed that a lower sample size might not provide a good representation of the normal unit to 
unit variation in lamp manufacturing. However, for certain parameters, Annex IV allowed for 
testing fewer lamps than 20. With regard to the suggestion that the parameter for setting the 
requirement on the energy efficiency of non-directional and directional LED lamps should be 
unified, the EU agreed with the Chinese authorities that a unification would be desirable in order to simplify the implementation of the Regulation  244/2009 and the currently planned Regulation. The 
EU was likely to propose an amendment of Re gulations 244/2009 and 245/2009 to that effect 
during the next review of the two regulations.  
2.186.  Regarding the Korean concerns on the requ irement specifying that a LED tube could only 
be claimed to be equivalent with a fluorescent tube of a particular wattage if certain conditions 
were fulfilled, she re-iterated that this requirement only referred to affixing the claim of 
equivalence on the product and in no way hinder ed the placement on the market of those lamps 
not complying with the conditions imposed to make such a claim.  G/TBT/M/59 
 
- 36 - 
 
  2.2.2.1.21  Australia – Joint Governments' Re sponse to the 2010 Independent Review of 
the Water Efficiency Labelling and Standard s Review (G/TBT/N/AUS/71) (IMS ID 366) 
2.187.  The representative of Korea expressed concern regarding Australia's consultation paper 
about the Joint Response of the Australian Government, States and Territories to the 2010 
Independent Review of the Water Efficiency Labelling and Standards (WELS) scheme. He 
underlined his government's respect for the efforts of the Australian Government to preserve water resources by reducing water consumptio n. The Korean Government agreed with, and 
supported the purpose of the WELS scheme for the protection of water resources. 
2.188.  Korea recalled that Australia had stated that one of the WELS scheme's objectives (as 
notified in G/TBT/N/AUS/71) was to improve cost  recovery for the operating system. While Korea 
had not objection to the additional cost that companies pay for the operating system, Korea was 
nonetheless concerned about the additional burdens implied by the annual registration 
requirement. The target products of the scheme included several products which had different 
product life cycles – and this needed to be take n into account in setting registration periods. 
Therefore, Korea had requested the Government of Australia to set the renewal period to be no 
less than three years for washing machines and dishwashers. If the Australian government could not accept the Korean proposal to set up another registration period for each product, Korea 
requested the Australia to amend the registration procedure to allow companies to choose either 
annual registration or registration according to the desired time period and pay registration fees in bulk.  
2.189.  The representative of Australia underlined that the changes to the WELS scheme had been 
implemented to enable it to recover 80% of its costs. Cost recovery was consistent with Australia's 
WTO obligations. Moreover, registering products annually meant that registrants would benefit from only paying for the period of registration  they needed. The rest of the changes had been 
designed to make the scheme more efficient and si mple. A significantly simplified process was now 
in place (as of 22 January 2013), and once the transition process was fully completed it would deliver substantial efficiency benefits. Feedback from registrants on the process changes had been 
very positive. Industry feedback, from domestic and international registrants, indicated that the 
new system had considerably reduced the administrative burden of registering products. The annual re-registration process had been made particularly simple. Businesses were only required to choose the models they wished to renew, indica te any relevant changes to certification, pay the 
fee, and declare that the information provided was correct. A renewal application did not have to 
be accompanied by previous certificates of conformity, as so long as those previously provided remained valid. Additionally, only one form was required and covered all the product renewals a 
business might wish to make in any given year.  
2.190.  The representative of Australia said that there might have been some misunderstanding 
that test certificates for products were previously  synchronised with the WELS 5-year registrations, 
which had never been true for all products. The new WELS system relied on a simple process 
whereby certificates provided at the time of registration were taken into account in applications for renewal, as long as the certificate remained current. Under the old arrangements it was possible for a certificate to lapse early in a five year registration period. In response to comments from 
Korea, the current system applied equally to all WELS products. It would be administratively 
burdensome and could be perceived as inequitable for different classes of products to be registered under different arrangements.  
2.2.2.1.22  Brazil – Draft ANVISA Resolution on Used, Refurbished, Rented and Lent 
Medical Devices (G/TBT/N/BRA/440) (IMS ID 362) 
2.191.  The representative of the European Union reiterated concerns regarding the ANVISA draft 
resolution on used, refurbished, rented and lent medical devices (G/TBT/BRA/440). The draft 
resolution prohibited the importation of medical equipment reconditioned overseas and whose last place of installation, before reconditioning, was not Brazil. At the latest TBT Committee meeting, Brazil had informed the Committee that a final draft was not yet available and that a public 
hearing would be organised. The EU wished to have  an update on the situation. The EU was of the 
opinion that any reconditioned equipment, independent of its place of first installation, should be allowed for importation in Brazil as long as it  complied with the health and safety performance 
requirements established in the Resolution. She al so reiterated that several developed countries 
such as the EU, US and Japan, which also had hi gh health and safety standards, accepted and G/TBT/M/59 
 
- 37 - 
 
  used refurbished medical devices. The EU invited Brazil to reconsider its Resolution and find other 
less trade restrictive means to fulfil its legitimate objectives.  
2.192.  The representative of Brazil stated th at the subject had already been discussed; he 
recalled that in July 2011, Brazil had notified th e public consultation 34/ANVISA of the Brazilian 
Health Surveillance Agency. A sixty day period ha d been opened for interested parties to provide 
their comments on the draft measure. During that period a significant number of comments had been received and they were still being examined and consolidated. He said that one of the main 
objectives of the draft measure was to avoid th e use of medical equipment being exported to 
Brazil as a means of final disposal of those products. He underlined that another important objective was obliging producers of medical equipment to be responsible for the appropriate disposal of medical equipment. He stated that a public hearing on this issue would be organized so 
that stakeholders would be able to participate in  an open and transparent exchange of views with 
the Brazilian regulators on this proposed measure which had not yet been implemented.  
2.2.2.1.23  Korea – KS C IEC61646:2007 Standa rd for Thin-film Solar Panels (IMS ID 
271) 
2.193.  The representative of the United States stated that her delegation had raised the issue of 
the Korean standard for thin film solar panels at every TBT Committee since June 2010, except for 
in November 2012. Korea required solar panels to be certified by the Korea Management Energy 
Corporation (KEMCO) to be eligible for government subsidies, which de facto  limited the Korean 
market to certified panels. KEMCO's certification standards prevented certain types of thin-film solar panels manufactured by US industry from entering the Korean marketplace. The US had 
consistently pressed Korea to adopt the relevant international standard: IEC 61646 in its entirety, 
without limiting its application solely to the type of thin-film solar panel its industry produced. In response to US concerns, the Korea Testing La boratory (KTL) had conducted an environmental 
impact review on the use of cadmium in solar panels. KTL released this review to the public at the 
end of June 2012 and Korea had provided a summary  of the study's results at the June 2012 TBT 
Committee meeting.  
2.194.  The US had reviewed the KTL study and had significant concerns. The global norm was to 
set regulatory limits for classifying waste based on standard waste characterization testing. The US observed that non-standard test results, such as those from availability testing in the KTL, should 
not be used to classify waste. Specifically, the avai lability test's use of finely ground material and 
multiple extraction cycles more closely mimicked the recycling process for CdTe PV modules – 
which had the explicit objective to separate and then recover and reuse metals from end-of-life modules – than the impact on any environmental conditions. The US was also concerned that KTL 
did not conduct availability testing on all PV tec hnologies (including those that had been certified 
against KS IEC 61646 and KS IEC 61215 and were sold in Korea) even though previous availability 
testing in Europe yielded levels of heavy metals (lead) comparable to KTL's availability testing on 
CdTe PV modules (cadmium). It was not scientific practice to compare results from leaching tests 
directly against health screening levels (e.g., drin king water levels) without first conducting Fate 
and Transport Analysis to evaluate the chemical tr ansformations and dispersion of chemicals in the 
environment in moving from the point of emissi ons to the point of exposure. Further, many 
scientific studies on Fate and Transport Analysis had found potential worst-case leaching impacts 
to be well below health screening levels and background levels in soil, air, and groundwater. Hence, the US reverted to and reiterated the concerns expressed at previous meetings of the 
Committee.  
2.195.  The representative of the European Union supported the US concerns and asked Korea for 
a n  u p d a t e  o n  i t s  w o r k  o n  s e t t i n g  u p  a  c e r t i f i c ation system for CIGS modules. According to the 
information provided by Korea at the June 2012 TBT Committee meeting, this process would take 
approximately two years, therefore allowing CIGS modules to be certified for the Korean market by mid-2014. However, according to information at the EU's disposal, the certification system might be made available sooner.  
2.196.  The representative of Korea underlined his delegation's sympathy for the concerns raised 
about CdTe modules by the US. He reiterated that the related certification system for thin film 
solar panels was not mandatory but voluntary, thus there were no restrictions in entering into the 
Korean market without the certification. Also, as had been explained at the previous TBT meeting, 
the Korean Government had conducted a two-year, comprehensive feasibility study which involved G/TBT/M/59 
 
- 38 - 
 
  Korean test methods for domestic waste as well as US EPA Method 1311 and the EU EN 12457 
method. The result of the study showed that wh en cadmium telluride modules were damaged or 
discarded, a significant amount of cadmium could be leached into the surrounding environment. The concentration of cadmium leached from thes e modules was much higher than the allowable 
levels specified in various national environmental standards. Therefore, Korea did not intend to 
adopt a certification system for CdTe modules. Korea had decided to adopt a certification system for CIGS modules that satisfied the national en vironmental standards and was working on setting 
criteria as well as installing necessary facilities for the certification. These preparations were 
expected to be completed by the end of 2014. Taking into account the interest of the WTO 
Members in the certification system, Korea was ma king attempts to shorten the period of these 
preparations so as to issue certifications  for CIGS modules as soon as possible.  
2.2.2.1.24  Colombia – Commercial Truc k 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) 
2.197.  The representative of Japan expressed two concerns regarding the "Commercial Truck 
Diesel Emission Regulation", notified on 14 December 2012 entering into force in September 2013. 
First, Japan requested Colombia to postpone the enforcement of the regulation. According to the 
draft regulation, Colombia would adopt the diesel emission regulation that was equivalent to EURO 
4 for light-duty vehicles and trucks and EURO IV  for heavy-duty vehicles . Currently, Colombia's 
diesel emission level was equivalent to EURO 2, EURO II, US Tier 1, US 94, etc. Thus, in order to comply with the proposed regulations, vehicle manufactures would need sufficient time to: (i) 
redesign and remodel cars; (ii) prepare manufacturing ; and, (iii) to get certification. According to 
the Japanese industry, it was estimated that it wo uld take more than 18 months to comply with all 
requirements in the new regulation. Therefore, Ja pan requested Colombia to ensure that the new 
regulation would enter into force 18 months from the date of publication in the Official Gazette at 
the earliest. Japan also asked Colombia to clarify the timing of the application of the proposed regulation. Japan requested that the proposed regulation should apply only to products imported in 
Colombia after its entry into force.  
2.198.  The representative of the United States noted that both the US Government and US 
industry had provided written comments to the amendment of Resolution No. 910 
(G/TBT/COL/185). The US requested a discussion of these comments prior to adoption of the final 
regulation since the US had serious concerns about the short implementation date of this 
regulation, particularly when normal implementation time frames for vehicle regulations were two to four years. The US therefore strongly urged Co lombia to extend its implementation period and 
reminded Colombia that it had acknowledged a temporary equivalence between Euro IV and EPA 
2004. Colombia was also asked to reconsider a permanent equivalency determination between the two standards, similar to Chile's example. She noted that fuel to meet the EURO IV standard would 
not be commercially available throughout Colombia for many years, which would result in 
equipment damage and a failure to meet environmental objectives associated with this measure.  
2.199.  The representative of Mexico reiterated concerns regarding Colombia's proposed 
modifications to Resolutions 910 of 2008 and 260 4 of 2009 on pollutant emissions from heavy 
vehicles with diesel engines. The full statement is contained in G/TBT/W/362. 
2.200.  The representative of Colombia explained that the standards at issue, particularly those 
currently notified to the WTO under G/TBT/N/COL/185 and G/TBT/N/COL/186, were aimed at 
achieving the legitimate objectives of protecting human health and life as well as the environment. 
The problem of public health caused by air pollution in Colombia was mainly associated with emissions from internal combustion engines and diesel emissions. According to a World Bank study 
in 2012, that had been requested by the Ministry  for Environment of Sustainable Development in 
Colombia, the cost of particular matter pollution  had increased from 0.8% GDP in 2004 to 1.1% 
GDP in 2009. Thus, there was a need to implement a strategy in order to achieve an effective reduction of particular emissions.  
2.201.  In light of this, Colombia had taken action to implement an overall public policy to improve 
fuels and vehicles to mitigate the negative effects of emissions in order to protect the environment and human health. In 2008, laws had been enacted with the effect that from 31 December 2012 
onwards, diesel would have a maximum content of 50ppm of sulphur when distributed in 
Colombia. In order to comply with the new regulations, investments of a sum of $8.5 billion to G/TBT/M/59 
 
- 39 - 
 
  update and modernise Colombia's refineries and reduce the content of sulphur in diesel from 
4500ppm to only 50ppm had been made. The repres entative nonetheless noted that Colombia's 
efforts would be diminished if emission standards were not adopted to take full advantage of the new diesel fuel. For this reason, Colombia be gan to update its emission standards and the 
technology required for local and imported diesel vehicles in 2011. When determining the 
appropriate emission standards in Colombia, the decisive criterion was a standard which would allow for a more efficient use of the new 50ppm sulphur diesel. Following a technical review and in 
accordance with international regulations in this area, the conclusion had been reached that the 
only standard which sufficiently met the legitimate policy objective to reduce particular emissions and where 50ppm sulphur diesel could be used, was standard EURO 4. Vehicles that complied with standard EURO 4 emitted up to 87% less particular matter than those vehicles that comply with 
current standards used in Colombia, such as the EPA 4.  
2.202.  The representative of Colombia acknowledged the considerable differences between 
standards and the possible adjustment cost that this measure could have on the market and for 
importers. The new modifications nonetheless provided an adaption period up to 31 December 
2014 for truck and tractor importers. Concerning Mexico's request, the representative noted that there would be a review of conformity assessment procedures.  
2.2.2.1.25  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) 
2.203.  The representative of the United States requested an update from Peru on the status of 
the proposed labelling requirements for foods containing ingredients made from genetically 
engineered (GE) crops. It was noted that the US and other Members had provided comments to Peru on the proposal, highlighting concerns about the potential impacts of the measure on trade. 
She noted that a mandatory labelling requirement for GE foods that were substantially equivalent 
to conventional foods could give the false im pression that the labelled food or feed was 
substantively different from, or less safe than, the conventional equivalent. In addition to 
misleading consumers, labelling would likely al so increase costs to industry, consumers, and 
government authorities. Rather than a mandator y labelling requirement, the US believed that a 
voluntary approach to GE labelling would allow for consumer choice at a lower cost and with less disruption to international trade. She asked Peru to clarify how it was taking the comments of 
other Members into account in finalizing the measure. In addition, she requested that, if Peru 
decided to move forward with implementation of this regulation, it provide clarity on the scope of the requirements as well as the implementing mechanism for monitoring, supervision, and 
verification of compliance to the labelling regulation. In addition, she asked that the 
implementation period be extended beyond the cu rrently envisioned 180 days in order to provide 
sufficient time for industry to adapt to the new requirements. 
2.204.  The representative of Chile reiterated concerns regarding Peru's draft technical regulation. 
These concerns had been submitted during the pub lic consultation process; they pointed at the 
need for interested stakeholders to find out mo re about the specific requirements found in the 
regulation, whether the measure allowed certification by foreign producers; and, whether there 
was a list of approved Peruvian accreditation laboratories. Chile noted that it was important to 
know the current status of the measure.  
2.205.  The representative of Colombia referred to the comments submitted by the US and Chile 
and also recalled that Colombia too had, on a number of occasions, expressed concerns to Peru 
about this issue. Peru was requested to  reply to the questions submitted.  
2.206.  The representative of Peru underlined that the concerns raised by the US, Chile and 
Colombia had been addressed at previous TB T Committee meetings. The draft regulations had 
been notified in June 2011 and Peru was aware of the concerns that had been expressed by these 
countries. Peru was currently assessing this matter to ensure that the measure was consistent with WTO rules, and in particular with the TB T Agreement. Peru was currently assessing the 
comments that had been received to see how they could be taken into account in the draft 
regulation. There was no specific date for adoption of the final technical regulation.  G/TBT/M/59 
 
- 40 - 
 
  2.2.2.1.26  European Union - Issue with Re spect to Honey Containing Pollen from 
Genetically Modified Maiz e MON810 (IMS ID 322) 
2.207.  The representative of Argentina reiterated concerns regarding the European Court of 
Justice Decision (EJC) of 6 September 2011(Case C-442/09) on honey containing pollen with 
traces of DNA from the genetically modified maiz e MON 810. Argentina believed that this decision 
had created a situation of clear inconsistency with the TBT Agreement as it re-interpreted the scope of regulation EC 1829/2003 on genetic modified foods and feed without technical or 
scientific justification. According to the ruling, pollen was an ingredient of honey and not a natural 
component for honey which was in contradiction with Codex standard 12/1981 on revision 2001 and the EU legislation (Annex II of Directive 2001/110 EC and Article 6 subparagraph 2 c) of Directive 2000/2013). In September 2012, the Euro pean Commission had presented a proposal to 
amend the Directive 2001/110 on honey in accordance with the ECJ ruling. This would be 
discussed at the Environmental Committee of the European Parliament and, at the same time, in the Council of Ministers. In this context it had been mentioned that there was a need for an impact 
assessment of this proposal, which would actually delay the resolution of this issue for an 
additional period of 6 months to one year. This situation had generated more concern in Argentina because the current legal uncertainty and its impa ct on trade would be aggravated and extended 
in time. Considering that a year and a half had passed since the ECJ ruling, Argentina requested 
the EU to update the Committee on the current  situation and the following programmed steps 
within the organizational structure of the Community and to promptly adopt all necessary measures to dispel the uncertainties resulting from the ECJ decision so as to eliminate their 
negative impact for honey exports to the EU, thus avoiding that the implementation measures of 
the ruling lead to honey export restrictions. 
2.208.  The representative of Brazil expressed an  interest in following the development of this 
discussion. Brazil was also concerned that the decision of the ECJ introduced legal uncertainty. 
This ruling established that honey containing pollen from genetically modified maize MON810 was a food product obtained from genetically modified organisms and, by consequence, subject to 
regulation 189/2003 on GMOs. This ruling seemed to  be contrary to Codex standards and also the 
European Regulation on the subject.  
2.209.  The representative of Canada expressed co ncerns regarding the impact of the ECJ ruling 
on GM pollen and honey. He understood, subsequent to bilateral meetings, that it would be 
clarified that pollen was a natural component of honey, not an ingredient.  
2.210.  The representative of Uruguay supported the concerns that had been expressed by other 
delegations. He urged the EU to take into consideration the economic impact which the measure 
could have on small family producers. He said that the measure was not scientifically justified and 
should thus be rejected on its merits and because of its damaging impact on the global food and security situation. In order to meet the challenges  of food security in the future there was a need 
for a competitive and environmentally responsible agriculture – barriers without scientific 
justification needed to be removed. He concluded that the application of private standards and measures which had an effect on trade and food production raised serious questions about the capacity to respond to the food shortages in the world.  
2.211.  The representative of the United States supported Argentina and other interested parties 
on the issue of restrictions towards GE pollen in honey. The US agreed that this ruling appeared to 
be a serious barrier to trade. This situation de monstrated that the EU GE approval process was 
overly lengthy and restrictive. Given the scient ific data available through numerous food and 
environmental safety authorities, it was not clear why the process was so laboured. She encouraged the EU to take expeditious action to resolve this trade disruption. In particular, the EU 
was urged to remove the trade obstacle of treating pollen as an ingredient, as this would be 
inconsistent with the Codex Alimentarius standard, upon which Directive 2001/110/EC was based - which did not treat pollen as an ingredient.  
2.212.  The representative of Mexico reiterated co ncerns regarding the ruling of ECJ in September 
2011 concerning honey containing pollen with traces of DNA GE modified maize MON810. She 
stated that this ruling contradicted what was established in the Codex and the EU standards in Annex II of Directive 2001/EEC and in Article 6 2C of Directive 2013. The prolonged legal 
uncertainty was affecting honey producers as they could not export their products to the EU.  G/TBT/M/59 
 
- 41 - 
 
  2.213.  The representative of the European Union stated that a detailed explanation on the 
background and implications of this ruling had been provided at previous meetings of the TBT 
Committee. In March 2012, Monsanto had submitte d an application for the authorization of MON 
810 pollen in food and feed and an authorization for the use of genetically modified pollen in 
honey. The application had been assessed by the European Food Safety Authority and a positive 
opinion had been issued on December 2012. The decision on the authorization of MON 810 pollen in honey was expected to be taken in April/May 2013. The EU underlined that the Commission had 
actively worked to ensure the proper implementation of the ruling without unnecessarily causing 
any disruption to the supply of honey to EU consumers, be it from domestic or imported production.  
2.214.  In September 2012, the European Commission had adopted a proposal to amend the 2001 
Directive on honey in order to clarify the true nature of pollen following the ECJ ruling. The 
proposal defined pollen as a natural constituent of honey and not as an ingredient. She furthermore noted that the proposed amendment wo uld have two key impact s. First, there would 
be no need to label pollen as an ingredient of honey as pollen was defined as a natural constituent 
of honey. Second, as pollen would no longer be considered an ingredient but a natural constituent, the amount of genetically modified pollen would be calculated in relation to honey and not to total 
pollen. The proposal was now being discussed at the European Council where the majority of 
member States supported the need to clarify th at pollen was a natural constituent of honey and 
not an ingredient. A vote at the European Parliament was expected during spring 2013.  
2.2.2.1.27  European Union – Draft Implementi ng Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for th e application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentati on of certain wine sector products 
(G/TBT/N/EEC/264, G/TBT/N/EEC/264/Add.1) (IMS ID 345) 
2.215.  The representative of the United States recalled previous concerns raised against the 
above-mentioned EU measure and requested information about the status of the applications that 
had been submitted by the US wine industry on  19 June 2010. The application process had taken 
over two and a half years for certain traditional terms and affected suppliers were unable to ship their products. In this context she again stresse d that the EU had granted approval to use the 
terms through bilateral agreements with other countries. She noted that the European Commission 
was to vote soon on the terms "chateau" and "clos" and would like an update on the applications.  
2.216.  The representative of Argentina reiterated concerns regarding EC regulations 479/2008 
and 607/2009 as they grant the EU Members the exclusive right to use certain traditional 
expressions in their own languages. He underlined that these rules restricted the rights of third 
parties to use those definitions on their wine labels, effectively also restricting wine exports from Argentina to the EU. He noted that Argentina believed that this legal regime was not consistent 
with obligations stemming from the TBT Agreement.  These traditional expressions only constituted 
indications of quality that fell within the scope of the TBT Agreement and not the TRIPs, thus neither registration nor the granting of exclusive rights over these terms was appropriate. He was concerned about requiring said registry when  there are diverging definitions of those 
complementary quality mentions at the European Community level, therefore failing to provide 
clear, objective and transparent quality parameters  for the use of said terms. He also expressed 
the concern that the EU had given, through bilateral trade agreements, other countries the use of 
these terms without a registration requirement which amounted to discrimination against the rest 
of countries with whom the EU had not had bilateral agreements. Nevertheless, for the last 4 years Argentina had engaged in discussions with the European authorities to overcome the obstacles of 
their regulations so as to continue to use the expressions "reserva" and "gran reserva" in the 
labeling of argentine wine to the EU. Finally, in March 2012, the dossier submitted by Argentina was approved by the Management Committee for the Common Organization of Agricultural Markets. However, there had already been an unjustified and unexplained one-year delay in 
including this subject in the agenda of the Co llege of Commissioners. Given that this issue 
remained unresolved for this additional delay, he again requested the EU to eliminate the unjustified restrictions that harm the argentine wine industry by including this topic in the agenda 
of said authority and by publishing the relevant regulatory act in the Official Journal.  
2.217.  The representative of the European Union reiterated that two applications submitted by 
two American wine associations in 2010, on the te rms 'Classic' and 'Cream', had been accepted in G/TBT/M/59 
 
- 42 - 
 
  the summer of 2012 and implementing European Commission Regulations had been published to 
that effect. She noted that the EU was still in the process of examining the other applications filed by US industry for the use of traditional terms and was updating the US on the status of these 
applications on a regular basis. As for the two ap plications from Argentina, they had been voted 
upon by the Single Common Agricultural Market Management Committee, and formal adoption by 
the Commission was pending .  
2.2.2.1.28  China - Draft Mobile Smart Termin al Administrative Measure, Ministry of 
Industry and Information Technology (MIIT), 10 April 2012 Strengthening the Administration of Network Access of Smart Mobile Terminals (G/TBT/N/CHN/928) (IMS 
ID 358) 
2.218.  The representative of Japan expressed three concerns on "Notification on Strengthening 
the Administration of Network Access of Smart Mobile Terminals" (notified on 21 November 2012). 
Several industries in Japan had submitted comments to China in January 2013. First, China was 
requested to clarify the definitions found in the draft: what goods were covered within the term 
"Smart Mobile Terminals"? What constituted "significant" in the context of Article 5 of the regulation named "Notification Regarding Strengthening Network Access Management for Mobile 
Smart Terminals"? Second, China was requested to relax its requirement of conditions for filing. 
Article 5 of the regulation stated that if a Sm art Mobile Terminal operating system (OSs) had 
significant changes in functionality or if new software applications were pre-installed, these changes needed to be filed with the Ministry of  Industry and Information Technology. Japan was 
concerned that such a requirement was more restrictive than necessary to fulfill the objective of 
securing personal information. While Japan understood that it was necessary to cope with security problems quickly, this requirement could impede timely responses – it needed, therefore, to be 
removed. Third, Japan was of the view that disclos ure and analysis of source code should not be 
required for the assessment of application software. The relevant document named "Test Methods for Security Capabilities of Smart Mobile Termin als" required source code analysis by testing 
bodies. In order to assess application software, these testing bodies had to be designated by the 
Chinese authorities. This requirement would make Japanese industries disclose source code for Smart Mobile Terminals, which could result in leaking confidential business information. 
2.219.  The representative of the United States appreciated the good work done on this measure, 
including bilateral engagement with China in April and May of 2012; the subsequent 21 November 
2012 TBT notification (G/TBT/N/CHN/928); and, Chin a's earlier action of publishing the draft 
measure on a Chinese government website soliciting comments. The US appreciated China's 
bilateral statement at the December 2012 US-China JCCT dialogue that it would modify and 
improve the notice based on a full consideration of  the views of all stakeholders. However, the US 
was still concerned about the apparent imposition of numerous new obligations, technical 
mandates, and testing requirements on information technology and telecommunications hardware, 
operating systems, applications, app stores, and other related services. The scope and mandatory 
nature of these requirements appeared unprecedented among the major global markets for mobile smart devices. Consistent with commitments made in the JCCT the US respectfully requested that 
China fully consider the views of Members before it finalized these regulations. 
2.220.  The representative of the European Union recalled concerns of a more systemic nature on 
the development of requirements of the MIIT in the ICT sector. He stated that this notification was 
a good example since it compounded a number of issues that had given rise to concerns of the EU 
in the past. It laid down additional requirements  in the procedure of acquiring a network access 
license and affected smart mobile terminals (SMT). On a positive note, the EU welcomed the 
improved transparency of the process, the pub lic consultation in April-May 2012, and the TBT 
notification, and hoped that this path would be fo llowed in the future. Nonetheless, the measure in 
of itself was overly prescriptive, and had a potential chilling effect on innovation. It also imposed burdensome test requirements, relied on so-called voluntary standards – i.e. industry standards – 
but which were mandated through certification procedures. These standards appeared to have 
been developed by the China Communication Standa rdisation Association. The EU therefore asked 
if this standards body, which appeared to operat e under the supervision of MIIT, applied the Code 
of Good Practice. The measure also included extensive disclosure requirements in terms of 
potentially requiring operators to disclose source codes of their operating system – this was sensitive confidential information so this requirement raised IPR concerns. In conclusion, he 
underlined that too prescriptive and burdensome  requirements might not improve smartphone G/TBT/M/59 
 
- 43 - 
 
  security, but would, on the other hand, stifle innovation and prevent timely and effective 
responses to security threats from malicious software.  
2.221.  The representative of China underlined that China already became the biggest consumer 
market of smart mobile terminals. In January 201 3, the total number of smart phones and tablet 
PCs was nearly 221 million. He underlined that Ch ina enjoyed the convenience which they brought, 
but also faced serious problems of leakage of user information. In order to protect user information security and personal privacy, China had developed this method according to relevant 
Chinese rules and international experience in the field. Based on the Chinese situation, network 
access management was a proper and effective measure to protect personal privacy, and the purpose was not to establish a new management ru le for telecom devices. During the process of 
developing the measure and the two relevant st andards, China had solicited suggestions from 
relevant domestic and foreign stakeholders.  
2.222.  In accordance with the TBT Agreement an d transparency obligations, China had notified 
the measure and the two standards to the WTO (G/TBT/N/CHN/928) on 21 November 2012. China 
had also several times communicated face to face with foreign relevant associations and clarified 
relevant information which they were concerned about. As regard to the scope of smart mobile terminal, it mainly included smart phones and tablet PCs which contained the mobile 
telecommunication module. The measure would not require disclosure of patent source code and 
other sensitive information and they would not prolong the approval of time for network access.  
2.3  Exchange of Experiences 2.3.1  Good Regulatory Practice 
2.223.  Pursuant to the recommendation in the Sixth Triennial Review, the Committee held a 
thematic discussion on Good Regulatory Practice on 5 March 2013. The Moderator of that Thematic 
Session provided an oral summary report of the presentations and discussion (G/TBT/GEN/143). 
2.3.2  Standards 
2.224.  Pursuant to the recommendation in the Sixth Triennial Review, the Committee held a 
thematic discussion on Standards on 5 and 6 Marc h 2013. The Moderator of that Thematic Session 
provided an oral summary report of the presentations and discussion (G/TBT/GEN/144). 
2.3.3  Next Thematic Sessions 2.225.  The representatives of Cuba, Ecuador and El Salvador stressed the importance of 
addressing the topic of special and differential treatment in a future thematic session. Ecuador 
proposed that a thematic session on both technical assistance and special and differential 
treatment take place in the October 2013 meeting of the Committee. 
2.226.  The representative of the United States  supported additional discussions on standards – 
and stressed that submissions from Members would be helpful to focus the discussion, particularly 
because the discussion during the thematic sess ion had been quite broad. Moreover, the US 
supported additional work on GRP in June, noting that there appeared to be momentum in that 
area. For October, the US would support discussions on technical assistance and capacity building. 
2.227.  The representative of European Union confirmed support for discussions on GRP 
considering the momentum and noted that the Committee had already agreed on specific follow-
up during the current meeting, so further work on GRP in June was appropriate. The EU was 
comfortable with a combined discussion of th e topics technical assistance and special and 
differential treatment in October. If other submissions were received from Members there was also the possibility of allowing smaller windows during the thematic sessions to address other topics if 
supported by analytical papers. At this stage there was sufficient substance to justify the 
discussions agreed. 
2.228.  The Chairman concluded that for the June meeting, the Committee would continue to 
discuss in thematic mode the topic of GRP, leaving open the possibility of discussing other matters G/TBT/M/59 
 
- 44 - 
 
  depending on submissions from Members. In Oc tober, the Committee would discuss: (i) technical 
assistance and special and differential trea tment, and (ii) conformity assessment.  
3  EIGHTEENTH ANNUAL REVIEW 3.1.  The Committee adopted the Eighteenth Annua l Review of the Implementation and Operation 
of the TBT Agreement as contained in G/TBT/ 33 and G/TBT/33/Corr.1. Relevant lists of 
standardizing bodies that have accepted the Code of Good Practice (in line with Annex 3 of the TBT Agreement) are contained in documents G/TBT/CS/1/Add.17 and G/TBT/CS/2/Rev.19.  
4  TECHNICAL COOPERATION ACTIVITIES 
4.1.  The Secretariat provided a document containing information on its technical assistance 
activities.
10 
5  UPDATING BY OBSERVERS 
5.1.  The representatives of IEC11, UNECE12 and the ITC13 updated the Committee on their 
activities. The representative of the BIPM,14 attending the Committee meeting as an observer for 
the first time, provided information on their activities relevant to the work of the TBT Committee. 6  DATE OF NEXT MEETING 
6.1.  The next meetings of the TBT Committee will take place in the week starting Monday, 
17 June 2013 and ending on Thursday, 20 June. The Seventh meeting on Procedures for 
Information Exchange will take place on 18 June 2013.  
 
 
__________  
                                               
10 G/TBT/GEN/149. 
11 G/TBT/GEN/145. 
12 G/TBT/GEN/146. 
13 G/TBT/GEN/147. 
14 G/TBT/GEN/148.