RESTRICTED  
  
G/TBT/M/68  
 
12 May 2016  
(16-2625)  Page: 1/70  
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 9-10 MARCH 2016 
CHAIRPERSON: MS ALANA LANZA 
Note by the Secretariat1 
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 (S TCs) ................................................................................... 2  
2.2.1   Withdraw n concerns ................................................................................................ 2  
2.2.2   New Concerns  ........................................................................................................ 2  
2.2.3   Previously Raised Concerns ..................................................................................... 12 
2.3   Exchange of information ............................................................................................ 67 
2.3.1   Thematic Sessions ................................................................................................. 67 
2.3.2   GRP paper ............................................................................................................ 68 
3   TWENTY-FIRST ANNUAL REVIEW .............................................................................. 68  
4   TECHNICAL COOPER ATION ACTIVI TIES .................................................................... 69  
5   UPDATING BY  OBSERVERS ........................................................................................ 69  
6   ELECTION OF CHAIRPERSON ..................................................................................... 70  
7   DATE OF NE XT MEETING ........................................................................................... 70  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/TBT/3. 
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
2.1  Statements from Members under Article 15.2  
2.1.  The Chairperson reminded the Committee of Members' notification obligation under 
Article 15.2 of the TBT Agreement and further info rmed the Committee that the latest list of 
statements on implementation submitted under this provision were contained in document 
G/TBT/GEN/1/Rev.15, issued 29 February 2016. She informed the Committee that since the last 
meeting in November 2015, Kazakhstan had submitted its statement. She further informed the Committee that since 1995, 132 Members had submitted at least one statement of implementation. Information on the li st of statements is available at http://tbtims.wto.org .  
                                               
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to thei r rights and obligations under the WTO. G/TBT/M/68 
 
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  2.2.  The representative of South Africa informed the Committee that his delegation would soon 
submit a revision to its Statement on Implemen tation and Administration of the TBT Agreement.2 
2.2  Specific Trade Concerns (STCs) 2.2.1  Withdrawn concerns 
2.3.  The Chairperson reported that the following  STCs had been withdrawn from the agenda at 
the request of the concerned Member:  
a. European Union - Directive 2014/40/EU of the European Parliament and of the Council 
on the approximation of the laws, regulations and administrative provisions of the 
member States concerning the manufacture, presentation and sale of tobacco and related products  
b. Finland – Draft Government proposal to Par liament for a Tobacco Act and Acts amending 
certain related acts  
c. Colombia – Ministry of Health and Social Protection Resolution 3117 of 2015 
d. Kingdom of Bahrain, State of Kuwait, Kingdom of Saudi Arabia, Qatar - Motor Vehicles: 
General Requirements "No. GSO 42:2003" 
e. Brazil - Toys 
2.2.2  New Concerns 
2.2.2.1  China - Formula Registration Regulation for Infant and Follow-up Formula, 
G/TBT/N/CHN/1165 
2.4.  The representative of the Republic of Korea expressed concern about the above-mentioned 
measure, notified on 7 January 2016, whereb y infant formula products manufactured in, 
distributed in, or imported to China must be registered at the China Food and Drug Administration 
(CFDA). Article 10 of the regulation stipulated that an applicant should submit data, including formula composition, whilst Article 19 made on-sit e inspection, sample testing and expert review 
compulsory. Further, according to Article 12, one company should not register more than 3 series 
of products and 9 product formula. Whilst fully understanding the need for strict controls of infant formula products, the Republic of Korea remained concerned about the requirement to register at 
CFDA, as well as the limitation on the number of infant products allowed to be registered. He 
pointed out that all Korean exporting companie s had been audited by the Certification and 
Accreditation Administration of China (CNCA)  during the 2014 on-site inspection and that 
information including formula compositions had been submitted to obtain registration of export 
facilities, product types and individual produc ts. It was therefore considered that the new 
regulatory requirement of registration at the CFDA , including repeated submission of data and on-
site inspection, constituted a duplicate regulation. Concerning the quantitative limitation on 
product registration, various kinds of products with different formulas could be manufactured 
depending on nutrients, percentage of active ingredients (milk or grain), animal species (cow or goat), product types (liquid or solid), fortified substances, use of organic substances, and others. 
International standard-setting bodies, such as Codex, also provided requirements for substances, 
but without limiting the number of brands and formulas. Korea considered that new measures introduced in the regulation might restrict Chinese customers' rights as well as their freedom to select and purchase safe and healthy products. Furthermore, the additional cost and time 
constraint of duplicate registration would be a considerable burden to exporting companies, 
constituting a barrier to the WTO principle of free trade.  
2.5.  Accordingly, the Korean Government requ ested that China accept the following: (i) to 
recognize Korean formula products and compositions previously assessed by and registered at the 
CNCA in 2014, once the CFDA's new regulation came into effect; (ii) to simplify the registration 
process for new infant and follow-up formula product compositions, to ensure that on-site 
                                               
2 This document was circulated on 6 April 2016 with the symbol G/TBT/2/Add.60/Rev.2.  G/TBT/M/68 
 
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  inspection and expert review were not duplicated in the course of new facility registration at CNCA 
and formula composition registration at CFDA; and (iii) to allow registration of new formula products through scientific demonstration of ingredients and compositions without limitation on the number of brands or formula compositions, if obvious differences in ingredients were scientifically 
demonstrated. 
2.6.  The representative of the European Union associated himself with Korea's concerns, 
particularly on the limitation which would apply to each company setting a maximum of 9 recipes 
within 3 product lines, stressing the potentially serious negative impact on EU exports to China. 
The impact of such a limitation would be aggravated by the fact that the limitation would affect producers who would be deprived of the possibility of serving major brands of infant formula who 
currently rely on them as production partners for their products. Without modification of this 
article, the number of brands on the Chinese mark et would be reduced by an estimated 80%. The 
EU could see no justification to this limitation, neither on the basis of food safety nor on the basis of any other legitimate objective. The EU requested reconsideration of this limitation and flagged 
that written comments had been sent to China covering other serious concerns. 
2.7.  The representative of Japan shared the co ncerns of Korea and the EU. Japan understood that 
Article 12 of the measure limited the maximum nu mber of products for which manufacturers, 
including foreign companies, could obtain registration to 3 brands per manufacturer and 3 
products per brand, in other words, 9 products per manufacturer. It was Japan's understanding that the measure would be unnecessarily trade restrictive, as it would reduce manufacturers' sales opportunities. Japan accordingly asked China to eliminate the quantitative limitation on 
registration of products. 
2.8.  The representative of China committed to co nveying all comments and concerns back to its 
capital, since the substantive issues raised by Me mbers were brought to her delegation’s attention 
at very short notice. 
2.2.2.2  India - Draft Food Safety and St andards (Alcoholic Beverages Standards) 
Regulations, 2015, G/TBT/N/IND/51 
2.9.  The representative of the European Union stated that in January 2016 the EU had provided 
detailed comments on India's draft alcoholic beverages regulation (notified in December 2015) 
establishing the requirements and definitions appl icable to different types of alcoholic beverages 
(such as spirits, wines and beers), as well as labelling requirements. He outlined several concerns 
on the notified draft. It was considered that, if  adopted in its current form, the draft regulation 
would create a number of unnecessary barriers to trade, particularly in consideration of its inconsistencies with current international practices, notably the oenological practices and 
definitions set by the International Organisation of Vine and Wine (OIV), as well as inconsistencies 
with Codex.  
2.10.  Regarding wines, Chapter 3 of the notified draft limited alcohol content in wine at not more 
than 15.5% by volume; as the OIV did not provide for maximum alcohol strength, India was 
therefore encouraged to remove such a limit. Furt her, the draft did not foresee the blending of red 
and white wine in the production of red wine, whereas the OIV allowed such practice. Sugar content set in the notified draft for ''dry'', ''medium'' and ''sweet'' wine was also not in line with the 
OIV standard. Concern was raised about the requirement that sparkling wines be subject to a 
second fermentation, and other types of requiremen ts for speciality wines, as explained in its 
written comments. Regarding beers, he noted that a number of requirements in the notified draft 
would render exports of some EU beers to India impossible. The notified draft set a maximum level 
of 8% alcohol by volume whereas the maximum alcohol by volume level obtained with traditional brewing (i.e. without fortification) was in the rang e of 15-18%. The notified draft also limited the 
type of flavours that could be used in the prod uction of beers. His delegation recommended that 
both natural and artificial flavours be allowed. The notified draft included ''clarity'' as a requirement for beers whereas for many others cl oudiness was desirable. Regarding spirits, there 
was concern for the maximum alcohol content of 50% by volume for some distillates and for a 
number of definitions/requirements for products such as brandy, cognac, vodka, whisky and 
others, which were not in line with OIV standards and would render exports of these products to India impossible. He went on to note that a number of labelling provisions were not in line with the 
Codex standard for the labelling of pre-packag ed foods (CODEX STAN 1-1985) such as India's 
requirement for the indication of an expiry date . Moreover, concern was raised on the ''allergen G/TBT/M/68 
 
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  and health warnings'' suggested in the draft and India was requested to amend and clarify such 
provisions. Further, he suggested that in the current notified draft India explicitly refer to an extensive list of additives allowed in the producti on of alcoholic beverages, including all those set 
by Codex and the OIV.  
2.11.  He concluded by asking the Indian authorities to take on board his delegation's comments 
before publishing the draft text, and recommended th at a reasonable transition period be provided 
to implement any changes necessary to comply with the new provisions, whilst allowing the sale of 
products already present on the Indian market until exhaustion of stocks. 
2.12.  The representative of the United States, whilst supporting India's efforts to develop safe and 
effective standards for regulating alcoholic beverages, considered that there were a number of 
areas where India's proposed standards fell outside of widely accepted international standards, 
and may be more trade restrictive than necessary. Following up on the comments recently 
submitted by the US, the regulation set a number of compositional limits for which standards did not exist in Codex, for example, levels for many chemical contaminants in alcoholic beverages. 
Limits regarding pH, carbon dioxide, and sugar levels pertained to the quality of alcoholic 
beverages rather than safety. She asked whether India had considered her delegation's request to include a number of additives frequently used in winemaking in the list of permitted additives and 
whether it could provide a scientific justification for such limits. If India had relied on specific 
scientific studies in setting these limits, it was urged to share them with the US.  
2.13.  Her delegation was also concerned with the labelling requirements associated with the 
measure and asked India to clarify whether stickers would be allowed to be placed on alcoholic 
beverages at port before the items went through customs. She requested a response to other 
important concerns, including irregular serving size measurements, limits for alcohol by volume (abv) that would prohibit many ciders, wines, and distilled spirits from being exported to India, 
and several compositional requirements that were either unclear or a cause for concern. In 
conclusion, she asked when India planned on finalizing and implementing the measure and stressed the importance of the provision of an adequa te transition period to allow industry to come 
into compliance with the measure.  
2.14.  The representative of Japan echoed the concerns raised by the EU and the US. Japan had 
submitted technical comments to India, considering that part of the proposed regulations was not 
in accordance with the international standards and international practice. Japan encouraged India 
to take its comments into consideration by revising the regulations, but suggested that if they 
were implemented as currently proposed, that a reasonable transitional period be provided. 
2.15.  The representative of Australia welcomed India's consideration of its comments and looked 
forward to its response, recalling the obligation to ensure consistency with the TBT Agreement. 
2.16.  The representative of Chile echoed concerns raised the EU and the US, specifically the need 
for classification of these alcoholic beverages as not all such beverages were being considered and 
thus were not in line with OIV definitions with re gard to additives. He expressed interest in the 
further development of this regulation and pinpoint ed the transitional period as a key issue. Chile 
sought India's indulgence in extending the de adline for comments beyond the standard 60 days. 
2.17.  The representative of New Zealand expressed support particularly for the interventions 
made by the US and the EU, underlining her delegation's concern that the new requirements 
proposed by the draft regulations were unnecessarily trade restrictive as well as unclear. Specifically, her delegation believed that wine should be seen as a single ingredient product and 
noted that numerically based labelling requirements such as the numerical definitions of wine and 
categories failed to take into account seasonal and regional variances in wine production, thereby constituting an unnecessary burden on wine producers. She looked forward to working with India 
and to hearing how India would respond to the concerns of wine producers and importers. 
2.18.  The representative of Guatemala expressed her delegation's concern and interest in closely 
following discussions. 
2.19.  The representative of Canada echoed the comments made by the EU and the US as his 
delegation was following with interest the development of the proposed regulation. In doing so, he G/TBT/M/68 
 
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  encouraged India to ensure that the regulation was not more trade restrictive than necessary to 
meet its legitimate objectives and that it did no t discriminate among like products. He asked India 
to confirm whether its intention was for the proposed regulations to supersede existing standards for alcoholic beverages manufactured or sold in India. Further, with respect to the proposed 
limitation in the range of alcohol content of wh iskies from 36% to 50%, he questioned India's 
rationale for this, since some vari ations of whisky did exceed 50%. 
2.20.  The representative of India recalled that the Food Safety and Standards Authority of India 
(FSSAI) had published the "Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulation, 2015" on its website on 29 October 2015, seeking comments from all stakeholders, followed by its notification as document G/ TBT/N/IND/51, with a 60-day comment period. The 
draft measure was still under consideration by the Indian authorities pending finalization. A more 
detailed list of permitted food additives was expected to be finalized in due course, and comments 
of WTO Members and other stakeholders were being considered appropriately in finalizing the measure. 
2.2.2.3  South Africa - Amendment to Re gulations Relating to Health Messages on 
Container Labels of Alcoholic Be verages, G/TBT/N/ZAF/48/Rev.1 
2.21.  The representative of the European Union recalled the proposed amendments to the 
regulation that were of concern to his delegation. The requirement for seven different health 
warnings to be rotated during a twelve-month cycle constituted an excessive burden and a potential technical barrier to trade, especially for small and medium enterprises. Some beverages 
had a lifespan-after-labelling of many years and pr edicting which label had to be used imposed an 
unnecessary burden on industry. Also of concern we re different requirements on the size of the 
health warnings, which would be increased to at least one eighth of the total size of the container instead of the current one eighth of the total size  of the label. Recalling Article 2.2 of the TBT 
Agreement, the EU asked the South African auth orities to share scientific evidence on the 
relationship between these new requirements and the fulfilment of a legitimate objective (e.g. 
protection of human health) by reducing the harm ful consumption of alcoholic beverages. The EU 
requested an update from South Africa on the status of the proposed amendment as well as a 
written reply to its comments.  
2.22.  The representative of Canada, whilst expressing support for South Africa's policy objective 
of promoting healthy choices related to alcohol, including the use of warning labels, voiced concern 
regarding the costs for exporters - notably smaller shipments - which would result from the 
change to the regulation requiring labels to be ex hibited with equal regularity to each other within 
a twelve-month cycle. If a Canadian exporter were to send 4 shipments a year to South Africa, 
would the new regulation require each of the 7 labels to be distributed equally among those 4 
shipments? If an exporter sent 700 bottles of wine  a year would they require 100 bottles each with 
the 7 different labels? Would it be possible to consider adding an amendment for smaller producers 
to reduce the cost burden? 
2.23.  The representative of Guatemala flagged her delegation's systemic interest in the topic and 
the desire to follow discussions closely. 
2.24.  The representative of South Africa recognized the interest in health messages on alcoholic 
beverage containers, an issue raised frequently as  a specific trade concern in the context of the 
clarification of labelling requirements, and underlined the need for government intervention via warnings about the public health and safety concern of alcoholic beverage misuse and of 
alcoholism. He informed the Committee that the regulation had not yet been adopted by its 
Department of Health. He went on to recall the previous day's thematic session on Good Regulatory Practice, which had highlighted the impo rtance of regulatory impact assessment, public 
consultation and legal overview. In this light, af ter a thorough public consultation process taking 
into consideration all comments received, the Department of Health had now referred the draft regulation to the South African State Law Advisors for legal overview. He summed up by stressing his delegation's commitment to the Fifth Triennial Review's "follow-up" recommendation in 2009, 
whereby the Committee had agreed to stress the importance of making addenda when a proposed 
regulation is either adopted, published or enters into force and especially in cases where the G/TBT/M/68 
 
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  relevant dates have not been provided in the original notification or have been changed3 and in 
this light would notify the Committee when the draft regulation had been adopted. 
2.2.2.4  United Arab Emirates - Control scheme  to restrict the use of hazardous materials 
in electronic and electrical devices  
2.25.  The representative of the European Union stated that his delegation shared the objective of 
the notified draft of restricting, to the extent possi ble, the use of hazardous substances in electrical 
and electronic equipment, with a view to protecting human health and the environment. He 
nonetheless wished to raise some issues of concern to his delegation. The lists of exemptions in 
Annexes 3 and 4 of the notified draft did not includ e many relevant exemptions included in similar 
regulations on the restriction of the use of certain hazardous substances in electrical and electronic equipment, as was the case in the EU's own legislation on the matter. In particular, exemptions for 
the use of mercury and other substances currently used for the production of light sources, such 
as bis(2-ethylhexyl) phthalate (DEHP), butyl benz yl phthalate (BBP), dibutyl phthalate (DBP) and 
diisobutyl phthalate (DIBP), would be forbidden without appropriate transition, which would 
certainly disrupt trade in this area. Regarding the enforcement of the restrictions laid down by the 
notified draft, it was noted that Article 4.1 was unclear and did not specify whether the restrictions listed in Annex 2 only applied when the electrical and electronic devices were placed on the market 
for the first time or also to the following market ing stages. The EU therefore kindly invited the UAE 
authorities to clarify whether or not, and how, the restrictions listed in Annex 2 applied to electrical and electronic equipment already on the market . The re-use, refurbishment and extension of 
lifetime of products already on the market was bene ficial for the protection of the environment, for 
which spare parts would need to be available. He asked the UAE authorities whether exceptions 
could be considered for the repair of products placed on the market before the application of the notified draft. Additionally, he highlighted that in Article 9.4 of the notified draft, the list of 
exemptions in Annexes 3 and 4 was related to "products", instead of "applications in a product", 
whereas the headings of both annexes referred to "applications"; an explanation was requested with regard to the exact scope of application of the exemptions at hand. As for the procedure for 
conformity assessment, the notified draft referred in Article 5 to "Model A" and to a submission to 
the Emirates Authority for Standardization & Metrology (ESMA), in Article 6 to registration, and in Article 8 to an application. Clarification was soug ht on the exact procedure for the placing on the 
market of products following the assessment by the manufacturer and the drawing up of a 
Declaration of Conformity, and in particular on whether a prior authorization by the UAE 
authorities was required. 
2.26.  The Chairperson asked that the EU's concerns  be conveyed to the delegation of the United 
Arab Emirates. 
2.2.2.5  Russian Federation - Ru les of cement certification  
2.27.  The representative of the European Union raised concerns about the new mandatory 
certification requirements for cement in Russia, following the approval in September 2015 of a law 
on cement certification making it subject to mandatory certification. According to this law, applicable from 7 March 2016, all cement made available in Russia would have to be certified according to the new GOST standard P 56836-2016 ("Validation of conformity. Rules of cement 
certification"), valid from 1 February 2016. This GOST standard had been approved on 11 January 
2016 by a ruling of the Ministry of Trade an d Production, Federal Agency for technical 
requirements. According to the new certification procedure, cement would have to be certified 
every six months by an authorized laboratory, a frequency deemed by the EU to be 
disproportionate and unjustified. It also seemed that only a few certification bodies had been designated to undertake the certification with considerable costs for the producers. Furthermore, 
even more burdensome procedures applied to cement imports from third countries. Imported 
cement, although already certified, was to be subj ect to additional border controls, samples to be 
taken from each shipment for testing. Imported cement might be stopped at the border for 28 days until the results of the tested samples became available.  
2.28.  In this light, the EU asked Russia for the reasons for such requirements for imported 
cement; whether such requirements applied only to  imported cement; if so, what the differences 
in treatment with locally produced cement were, and their justification; and which countries were 
                                               
3 G/TBT/26, para 43(b) G/TBT/M/68 
 
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  considered as third countries. In addition, the EU requested further information from Russia on the 
meaning of shipment (whether it would mean each wagon, a whole train or the yearly production), by whom and how these samples would be taken from imported cement, how the tests would be performed, their length, and whether, after sampling and testing, the imported cement would be 
allowed to proceed further to the unloading point and/or to the end consumer or each time they 
were to be stopped at the border for 28 days. Russia was invited to provide further information on the health risks invoked in relation to certain imported cement products and on the reasons why 
each shipment of imported cement had to undergo testing. Finally, the EU asked Russia to 
suspend application of the measures in questi on pending their notification under the TBT 
Agreement, providing Members with the opportunity to comment on them. 
2.29.  The representative of Mexico shared the concerns raised by the EU on this regulation. 
Mexico would seek further clarification from Russia on some elements of the measure and asked 
that this measure be notified to the Committee. 
2.30.  The representative of the Russian Fede ration stated that Federal Law No. 184-FZ of 
27 December 2002 "On Technical Regulation" and the Treaty on the Eurasian Economic Union of 
29 May 2014 were the basis of the technical regulation. The Eurasian Economic Union currently lacked a technical regulation containing cement requirements. Federal Law requirements would 
apply until the Eurasian Economic Union technica l regulations were adopted. Pursuant to the 
requirements of the Federal Law, Government Resolution No. 982 of 1 December 2009 "On Approval of the Single List of Goods Subject to Mandatory Certification and Single List of Goods Subject to Conformity Confirmation Procedures by  means of Conformity Declaration" would apply. 
Government Resolution No. 930 of 9 September 2015 "On amendments of the Single List of Goods 
Subject to Mandatory Certification" added cement to the list, in response to a sharp decrease in cement quality in circulation in the Russian Fede ration and due to urgent problems of safety, 
health and environmental protection. His delegation was of the opinion that the measure would not 
have a significant effect on trade of other Members. He explained that the Russian Federation was a major exporter of cement and that domestic production covered more than 94% of total 
consumption, more than 50% of imports coming from countries (members of the Eurasian 
Economic Union) already having implemented the mandatory certification of cement. The draft government decree had been published on the official website of the Russian Federation 
Government on 13 March 2015.
4 Government Resolution No. 930 had been notified to the WTO in 
document G/TBT/N/RUS/48 in accordance with Article 5.7.1 of the TBT Agreement. He would bring 
other questions of the EU and Mexico to th e capital and would provide answers shortly. 
2.2.2.6  Hungary – Proposal for Government Decree on the amendment of Government 
Decree 39/2013 (of 14 February 2013) on the Manufacture, Placement on the Market 
and Control of Tobacco Products, Combined Warnings and the Detailed Rules for the Application of the Health-Prot ection Fine, G/TBT/N/HUN/31 
2.31.  The representative of Indonesia said that while Indonesia respected Hungary's intention to 
pursue a public health policy so as protect consumers from the negative effects of tobacco 
products, his delegation had concerns that this measure was more restrictive than necessary. The full statement is contained in the document G/TBT/W/440. 
2.32.  The representative of the Dominican Repub lic thanked Indonesia for raising this issue. Her 
delegation fully supported the concerns raised. The Dominican Republic along with Cuba, Honduras 
and Indonesia were currently examining the me asures on plain packaging implemented in 
Australia through the WTO Dispute Settlement System. She said these measures were inconsistent 
with WTO Members' commitments under the TBT and TRIPS Agreements. Experts had put forward extensive evidence and arguments to the panel including evidence related to how these measures 
actually worked in the three years since their adoption. The Dominican Republic believed that 
based on the arguments and evidence put forward,  the panel would conclude that plain packaging 
measures were an ineffective way of addressing tobacco control. Alternative, less trade restrictive, measures, such as increasing the minimum age for buying tobacco products or increasing tax on 
those products, would achieve the objective of  reducing tobacco consumption. These were 
particularly effective disincentives for youth consumption. The Dominican Republic encouraged 
                                               
4 http://www.regulation.gov.ru  
 G/TBT/M/68 
 
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  Hungary not to implement any plain packaging measures until the findings of the panel on the 
Australian measures were known. 
2.33.  The representative of Guatemala said her delegation was following this issue closely and 
aligned itself with the concerns expressed by other Members.  
2.34.  The representative of Cuba also thanked Indonesia for raising this issue and aligned her 
delegation with the statements made by Indone sia and the Dominican Republic. Plain packaging 
was an unnecessary barrier to trade that lacked any scientific evidence proving that it led to 
improved health. Less trade restrictive alternatives existed. Like the Dominican Republic, she 
urged Hungary not to publish the legislation until the DSB panel findings were made available. 
2.35.  The representative of Australia reiterated his delegation's strong support for other WTO 
Members' decisions to legislate for the mandatory plain packaging of tobacco products and 
congratulated Hungary on its recent notification of such measures. He said the important steps 
taken by Members in tobacco control demonstrated that efforts to delay the adoption of tobacco plain packaging measures had not been successful. Australia was of the firm view that Members 
had the right to implement measures necessary to protect public health, while complying with 
international treaty obligations including the TBT Agreement. Tobacco plain packaging was a legitimate measure, endorsed by leading pub lic health experts as well as by the WHO and 
supported by extensive peer reviewed research, reports and studies. Given that Australia's 
measure was currently the subject of dispute proceedings, it was not appropriate to comment further. Australia felt it was also inappropriate for complainants in WTO disputes to invoke those proceedings in an attempt to delay or discourage other Members from developing or implementing 
their own legitimate tobacco control measures. 
2.36.  The representative of Canada supported Australia's comments. As a trailblazer with regard 
to measures in this area, Canada believed that plain packaging was an essential element in 
regulating in favour of public health. He was inte rested to hear other Members' views with regard 
to the fair balance between regulation, international trade and public health. Canada was committed to introducing the plain packaging requirements and would follow with great interest 
developments in this issue. These measures were being examined to see how they might be 
applied in Canada where there could also be restri ctions on the use of colours of trademarks, logos 
and graphics on tobacco packaging. Any proposal would be notified to the WTO. 
2.37.  The representative of New Zealand supported comments made by others in backing 
Hungary's tobacco plain packaging measure. There was extensive and growing research that plain 
packaging and/or health warnings, as part of a comprehensive tobacco control programme, would contribute to improving public health. Additi onally, those Members who had implemented plain 
packaging measures showed that post-implementation, these measures were working as intended. 
The TBT Agreement recognized the fundamen tal right of Members to implement non-
discriminatory measures necessary to protect public health. New Zealand believed it was possible 
to implement plain packaging regimes that were consistent with all WTO obligations including 
those under the TBT Agreement 
2.38.  The representative of Norway supported the important steps taken by Hungary and other 
Members in tobacco control measures. As tobacco smoking was the leading single cause of early 
death and illness in Norway, there was strong support for tobacco control measures so as to 
achieve a tobacco free society in the long term. Norway had launched a public consultation on standardizing tobacco packaging in March 2015 and the preparation of the bill was now in the final 
stages. This bill would soon be sent to the parliament and most likely be adopted towards the end 
of 2016. 
2.39.  The representative of Uruguay said that given Uruguay's well-known position in support of 
tobacco plain packaging measures, the statements made by his delegation in previous meetings 
should be also be taken into  account on this measure.  
2.40.  The representative of Nigeria supported the concerns raised by other Members. While 
recognizing Hungary's right to take appropriate measures to protection public health, it was 
important for Members to question whether such me asures were consistent with the provisions of 
WTO Agreements. She requested that Hungary ta ke into account the comments of concerned G/TBT/M/68 
 
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  Members and reverse the decision to introduce this  measure. Her delegation would provide a full 
statement at the next meeting of the TBT Committee.  
2.41.  The representative of the European Union reiterated that tobacco products had recognized 
harmful effects on human health and Article 2.2 of the TBT Agreement included the legitimate 
objective of the protection of human health. It was recognized that any measure pursuant to this 
legitimate objective must not be more trade re strictive than necessary and create unnecessary 
obstacles to international trade. Article XX(b) of the GATT 1994 also emphasised the importance of 
public health by justifying measures "necessary  to protect human …health". The Hungarian draft 
decree aimed at protecting public health by introducing additional measures for tobacco control, targeted in particular at reducing smoking initiation among young people. In addition to the provisions implementing the EU Tobacco Products Directive, the draft included examples of plain 
packaging of tobacco products. This measure was the latest strand in a comprehensive range of 
tobacco control legislation already in place in Hungary aimed at decreasing tobacco consumption. Under existing legislation, there was already a ban on advertising of tobacco products, as well as 
sponsorship linked to tobacco products; a prohibit ion on smoking in enclosed public places and 
public institutions; the majority of tobacco products featured packaging bearing health warnings combining images and illustrations; tobacco products could only be sold in dedicated retail units 
and only to adults over the age of 18; and several tax increases on tobacco products, most 
recently in April 2015. In addition to the notified draft, Hungary had also made an impact assessment available which detailed the rationale of the measure and its expected economic and 
health impacts. Hungary had also notified the measure to the European Commission in accordance 
with internal EU requirements. Comments an d opinions had been made by the European 
Commission and some EU member States, which had been replied to by Hungarian authorities. No 
comments had yet been received from WTO Members under the WTO TBT notification procedure 
where the deadline for comments was 22 March 2016. 
2.2.2.7  France – Amendment 367 on Biodiversity Law  2.42.  The representative of Indonesia expresse d its concern with the consistency of Amendment 
367 with the WTO principles of national treatmen t and non-discrimination. Its full statement is 
contained in document G/TBT/W/441. 
2.43.  The representative of Brazil shared Indo nesia's concern and requested clarification on the 
nature of the amendment, as it appeared to refer to a tax measure concerning third-country 
environmental damage. 
2.44.  The representative of the European Union noted that the general objective of the French 
draft Biodiversity Law was the better protection of natural resources and ecosystems and agreed 
with Brazil that amendment 367 proposed by a group of French senate members did indeed 
provide for an additional tax on palm oil used in food. However, the draft measure did not fall 
under the scope of the TBT Agreement and as su ch the present Committee was not an appropriate 
forum in which to discuss it. In terms of the state of play of the adoption procedure, the draft law 
had been approved in the first reading by the Na tional Assembly and the Senate, and submitted to 
the National Assembly for a second reading on 27 January 2016. 
2.2.2.8  Russian Federation – Implementation plan related to excise tax on palm oil and 
soda products  
2.45.  The representative of Indonesia expre ssed its concern that the Russian Federation's 
implementation plan potentially violated GATT Arti cle III:2 on National Treatment as well as being 
inconsistent with the TBT provisions of non-discrimination and avoidance of unnecessary trade 
barriers. The full statement is contained in document G/TBT/W/442. 
2.46.  The representative of the Russian Federati on welcomed the opportunity to bring clarity to 
the list of products on which excise taxes are levied in order to avoid any future misunderstanding. 
His delegation considered that the matter was not covered by the TBT Agreement by virtue of the fact that the inclusion of certain products in a list of excisable goods did not relate to technical regulations, standards or conformity assessment pr ocedures. He indicated that the legal basis for 
excise taxation was set out in Chapter 22 of the Tax Code of the Russian Federation in which the 
corresponding list of products was also to be found. Any product listed, whether imported or G/TBT/M/68 
 
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  domestically produced, was subject to identical excise tax rates – and no changes had been made 
to the list in the previous five years. It was noted that discussions were currently underway in Russia concerning hypothetical changes to the lis t of excisable goods and underlined that these 
were broad public discussions, rather than a governmental plan. Different approaches were being 
discussed, including, inter alia, the inclusion of palm oil, tyres, soft drinks, and other products. It 
was expected that the discussions would result in the drafting of amendments to the Tax Code and that these would fully address the interests of stakeholders, consumers, whilst being in full 
compliance with WTO law. Proposals would be available for public comment on the website of the 
Government of the Russian Federation. Finally, attention was drawn to the requirements for palm oil and other oils established in Customs Union technical regulations "On oil and fat products"; these were in full compliance with the international standard CODEX STAN 210-1999 and with 
provisions of Article 2.4 of the TBT Agreement. 
2.2.2.9  Bolivia - Food Labelling and Advertising Law 2.47.  The representative of the United States  expressed support for Bolivia's public health 
objectives of reducing obesity and related non-communicable diseases. Given the potential trade 
impact of Law No. 775 "Promoting Healthy Eating" which was promulgated on 8 January 2016, the US asked Bolivia to notify the implementing regula tions of the law to the TBT Committee. Could it 
elaborate on the next steps in implementing the Healthy Eating Act, including the process for 
drafting its corresponding technical regulations? How would Bolivia be able to take into account further scientific information and research now that PAHO nutrient levels had been codified? She expressed her delegation's commitment to work ing with Bolivia on this important matter. 
2.48.  The representative of Guatemala expresse d her delegation's concern over the lack of 
transparency and compliance with notification requirements, which would normally allow for public 
consultations among Members prior to implementa tion of the measure. Guatemala acknowledged 
the legitimacy of the measure's public health ob jective of preventing diet-related diseases.  
However these requirements appeared to place th e blame solely on processed food. There were 
also concerns with the application and implementation period of the measure. Guatemala was 
closely following the development of discussions on this measure and urged Bolivia to notify its 
measure and to establish a period for public consultation. Moreover, Guatemala was concerned that the labelling regulations had not considered the Codex Alimentarius discussion. 
2.49.  The representative of the European Union echoed concerns raised by the US, in particular 
regarding the absence of notification of the measur e. Whilst fully supporting the final objective of 
this measure - the protection of human health - his delegation recalled the obligations established by the TBT Agreement on the notification of technical regulations in order to give other Members 
the opportunity to provide comments, and regretted Bolivia's lack of compliance with this 
obligation. As the EU was in the process of anal ysing the content of the measure, it requested 
Bolivia to suspend the application of the measure,  notify it to the WTO and provide enough time 
for Members to provide comments. 
2.50.  The representative of Canada, echoing the comments made by the US, Guatemala and the 
EU, expressed support for the objective of the pr otection of human health but urged Bolivia to 
notify the measure to the TBT Committee, at which time Canada would provide substantive 
comments through the enquiry point process and in the meantime requested Bolivia to suspend 
the measure.  
2.51.  The representative of the Plurinational State of Bolivia assured Members that concerns 
raised in an informal meeting between its focal point and the delegation of the US, as well as in 
the present meeting, would be dealt with by the a ppropriate bodies in capital. In the meantime, he 
informed Members that the Government of Bolivia had adopted Law No. 775 promoting healthy 
eating and that it was currently in the process of being developed as appropriate in consideration 
of the provisions of the TBT Agreement. He assu red Members that the regulation would be made 
available to Members as established in the TBT agreement when ready. 
2.2.2.10  Indonesia – Halal Prod uct Assurance Law No. 33 of 2014 
2.52.  The representative of the United Stat es, recognizing the importance for Indonesian 
consumers of knowing whether products are halal, expressed its commitment to work with G/TBT/M/68 
 
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  Indonesia to ensure that this objective was achieved without creating any unnecessary barriers to 
trade. She reiterated her delegation's hope that  previously noted concerns would be addressed 
through implementing regulations. It was their under standing that the Ministry of Religious Affairs, 
in conjunction with a number of other governme nt ministries, was currently drafting the new 
implementing regulations and requ ested an update on their content and status, as well as on 
preparations to set up the new institution provided for in Presidential Decree 93/2015. During the development of the implementing regulations, Indo nesia was urged to ensure that the drafts were 
submitted to the TBT Committee prior to being finalized in order to allow for sufficient notice and 
comment from all stakeholders and to allow time  for those comments to be taken into account. 
2.53.  The representative of the European Union shared the concerns raised by the US. According 
to the information available, the scope of the law was very broad and extensive, affecting, among 
other sector, food and beverages, pharmaceutical and cosmetics. The law would be implemented 
gradually and enforced as from 2019. However, ce rtain Halal requirements had already been set 
out in separate regulations (e.g., for imports of carcasses and meat). His delegation considered 
that the lack of transparency on implementing  rules and this fragmented approach created 
uncertainty as to the requirements applicable at any point in time. The EU requested that Indonesia notify the law via the TBT notification system, as well as any subsequent implementing 
rules, and that reasonable time be allowed for Members to comment, in accordance with Article 
2.9 of the TBT Agreement. In particular, on Halal certification and labelling, the EU requested clarification as to whether the provisions on mandatory labelling would also apply to non-Halal products. It also welcomed information on any other potential trade restrictions that the law might 
bring to non-Halal products. 
2.54.  The representative of Brazil expressed his delegation's interest in following the matter 
closely, especially with regard to the obligation for non-discrimination between domestic and 
imported products under the WTO TBT Agreement. 
2.55.  The representative of Indonesia provid ed responses to the intervening delegations, 
contained in document G/TBT/W/443.  
2.2.2.11  Thailand – Milk Code – Draft Act on Controlling to the Marketing Promotion on 
Food for Infant and Young Children and Ot her Related Products BE, G/TBT/N/THA/471 
2.56.  The representative of the United States stated that while her delegation strongly supported 
efforts to ensure that marketing of infant formula did not negatively impact breastfeeding, it was 
nevertheless concerned with the clarity of the draft measure, and in this light urged Thailand to 
allow for sufficient time after publication of the final rule and before implementation and enforcement, for further bilateral technical disc ussions, allowing US industry to come into 
compliance with the measure.  
2.57.  She expressed concern that the regulatory approach outlined in the draft may be more 
trade restrictive than necessary. Following up on the comments previously submitted through the 
Enquiry Point, the US asked Thailand to provide a scientific explanation for its complete ban on 
marketing and advertising on follow-up formula intended for children up to 36 months of age. In particular, scientific explanation was requested for how a ban on health claims and trademark information on labels would help accomplish the desired goal of increasing and sustaining 
breastfeeding. Further, explanation was sought as to the lack of distinction in regulating the 
marketing of infant formula and follow-up formula. 
2.58.  She went on to note that the draft proposed treating violations of the advertising and 
marketing requirements as criminal offenses as well as imposing prison time for certain offenses. 
The US sought clarity on the reasons for the necessity of criminal penalties, as well as additional detail with respect to the procedures for prosecution. She also recalled the voluntary nature of the 
WHO's International Code of Marketing of Breast-Milk Substitutes in the US, complemented by 
similar codes developed by leading US medical pr ofessional societies on the marketing of these 
products. Finally, she enquired if Thailand had an estimated timeframe for the ratification of the measure and flagged her delegation's intention to deepen technical engagement with Thailand on 
how to achieve its health objectives without negatively impacting trade.  G/TBT/M/68 
 
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  2.59.  The representative of Thailand thanked the United States for its comments, which would be 
passed on to the Department of Health, under the Ministry of Public Health, for consideration. She 
informed the US that the draft act was in the process of being published in the Government 
Gazette and that it would only come into force 180 days following the date of publication. 
2.2.3  Previously Raised Concerns 
2.2.3.1  India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40,  G/TBT/N/IND/40/Rev.1 (IMS ID 133) 
2.60.  The representative of Japan expressed concern regarding this long-standing issue, dating 
back to 2011. He stressed four points in partic ular: (i) the ISI marking fee requirement on every 
tyre on which ISI mark was attached, regardless of the destination country; (ii) the high cost of the marking fee; (iii) the length of time needed fo r certification; and, (iv) the bank guarantee fee 
which was required only for tyre factories outs ide India. On the cost of the fee, Japan had 
repeatedly showed India the evidence that the ISI marking fee was expensive compared to other 
countries and requested India to reduce the fee.  
2.61.  Japan also requested that India review the increase in the Conformity of Production (COP) 
testing frequency, which had been announced at the end of November 2015. India had announced 
that the test frequency would become "once in three months" from current "once in two years", 
and furthermore, the frequency of some tests was "earlier one of every 10th control unit (50,000 
numbers) of a family or once in a year" and the frequency of the other tests was "every control unit (5,000 numbers) of a family". Although an annual frequency was feasible, adding the condition of per manufacturing number would make the frequency excessive. For example, if a 
tyre was manufactured by 300 thousands per year, the frequency of the former test would be 6 
times a year and the latter test would be 60 times a year. Management by manufacturing number was a complex requirement for the tyre industry that had never been seen in other countries 
before. Japan considered that it would be possi ble to ensure safety with the previous test 
frequency. Japan requested that the test freque ncy not be per number of manufacturer, but per 
period, or once a year. 
2.62.  The representative of the European Union reiterated his delegation's concerns about the 
Indian Quality Order on Pneumatic Tyres and Tubes for Automotive Vehicles, which introduced a 
certification procedure with a mandatory marking fo r tyres. The EU referred back to its statements 
concerning the ISI marking fee and the USD 10,000 bank guarantee. In particular, the EU 
requested India to align its procedures with inte rnational practices and remove the obligation to 
pay a marking fee per marked tyre as well as to eliminate the discriminatory bank guarantee requirement. During the last meeting of the TB T Committee, the EU had asked India to provide 
information about the frequency of the new COP testing on tyre varieties exported to India. Since 
that meeting, the EU had received information that further changes in the testing requirements had taken place. These were set up by the Scheme of Testing Inspections (STI) 15633/5 of 
November 2015. The new measure introduced the concept of a "control unit" (a control unit 
meaning 5,000 tyres of the same family). It required testing of every tenth control unit for load and speed performance, endurance test, bead unseating resistance test and tyre strength test. The EU considered these testing requirements ex tremely burdensome and costly and asked what 
specific safety-related objectives India was pursuing  by requiring such frequency in testing. Finally, 
as this requirement seemed to stem from a new measure, which had not been notified under the TBT Agreement, the EU asked India to notify the measure.  
2.63.  The representative of India noted that most of the issues raised were not new and had been 
sufficiently explained in previous meetings. He requested interested delegations to refer to 
previous minutes, particularly of the meeting held in March 2015.5 Regarding the frequency of 
testing STI (Scheme for Testing and Inspection),  the STI for Pneumatic Tyres for passenger car 
vehicles as per IS 15633 had been revised as STI/15633/5 in November 2015. One sample had to be tested for every 50,000 tyres compared to once in three months specified earlier in STI/15633/4. In case quantity of some varieties was less than 50,000 in a year, it was specified 
that they needed to be tested once a year. However, based on the feedback received, some more 
inputs had been sought from the manufacturers and BIS would review the STI frequency further on receipt of the information. 
                                               
5 G/TBT/M/65, paragraphs 2.41, 2.42 and 2.43. G/TBT/M/68 
 
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  2.2.3.2  China - Provisions for the Administ ration of Cosmetics Application Acceptance, 
G/TBT/N/CHN/821, G/TBT/N/CHN/937 (IMS ID 296) 
2.64.  The representative of Japan asked China to clarify how the "Guidance for Application and 
Evaluation of New Cosmetic Ingredients" would be updated (in particular with respect to the 
contents and schedule) in accordance with the revision of the "Regulations concerning Hygiene 
Supervision over Cosmetics". Regarding the current version of the "Guidance", he said that Japan remained concerned with the following three issues: the speed of examination, the safety 
evaluation requirement, and the information disclosure.  
2.65.  The representative of the European Union reiterated his delegation's concerns in relation to 
the pace of progress on the procedure for the authorization of new ingredients. The EU also 
welcomed plans to set up a differentiated approach  between priority ingredients, which were of 
higher risk, requiring a pre-market registration, and ordinary ingredients, which would only need 
to be notified to the competent Chinese authorities.  In this respect, the EU asked China to indicate 
the state of play and the planned timeframe for th e adoption of this change. The EU also asked 
China to explain the current state-of-play of th e new Chinese draft on Cosmetics Supervision and 
Administration Regulation. 
2.66.  The representative of China explained th at the provisions for the Administration of 
Cosmetics Application Acceptance had been notified on 8 July 2011. Since then, China's Food and 
Drug Administration (CFDA) had offered specialized training and guidance on the difficulties enterprises had met in the implementation of this measure. In addition to cooperation at the governmental level, CFDA had kept bilateral chan nel open and had formed several working groups 
on this issue with several Members. She also said that the CFDA had paid great attention to the 
approval of new cosmetic ingredients. The term  "new ingredients", she explained, referred to 
natural or synthetic materials that were used to ma ke cosmetics for the first time in China. Before 
a new ingredient was used, a registration had to be made to the relevant authority for approval. 
Previously, the determination of a new ingredient had been done solely by experts on the basis of their personal experience, in the ab sence of an objective criterion.  
2.67.  The representative of China noted that her delegation attached importance to this issue and 
was in communication with both domestic and foreign businesses and industry organizations to carry out research on this matter in order to find  effective ways to solve the problem. After three 
rounds of public consultations, a catalogue of 8, 783 cosmetic ingredients already used in China 
had been published on 30 June 2014. She said th at another deficiency hindering the registration 
process was the absence of a classification syst em for new ingredients. According to the draft 
revision of Regulations Concerning the Hygiene Supervision over Cosmetics, a new classification 
system would be set up for cosmetics. In the new system, she said, only higher risk substances 
such as aseptic, sun-screening agents, colouring agen ts, hair colorants, and skin lighteners require 
registration with the relevant authority, while lo wer-risk substances just needed to be filed. 
Moreover, different documentation requirements would apply to different substances to accelerate 
the authorization process in an efficient and predictable manner. China would keep the bilateral channel open and welcomed interested parties to continue to cooperate with China and put forward valuable inputs.  
2.2.3.3  India – New Telecommunications-related Rules (Department of 
Telecommunications, No. 842-725/2005-VA S/Vol.III (3 December 2009); No. 10-
15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.I II/Vol.II/(Pt.)/(25-
29) (28 July 2010); Department of  Telecommunications, No. 10-15/2009-
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) an d accompanying template, "Security and 
Business Continuity Agreement" (IMS ID 274) 
2.68.  The representative of Canada reiterated  concerns with India's testing requirements for 
telecommunications products, and supported the points made by the EU in the last meeting.6 He 
believed that India's in-country security testing regulations for telecommunications products would 
hinder, or possibly shut, Canadian exports out of the Indian market. Canada disagreed with the 
universal approach applied by India to testing in the telecommunications sector and did not understand why Common Criteria Recognition Arrangements (CCRA) testing was not appropriate 
                                               
6 G/TBT/M/67, para 2.75.  G/TBT/M/68 
 
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  for India's telecommunications framework, given that it was already internationally accepted. 
Authorizing accredited foreign conformity asse ssment bodies to test and certify to India's 
regulatory requirements would reduce testing costs and permit exporters to bring their products to 
the Indian market more quickly. Canada apprecia ted the explanation of India's approach provided 
at the previous meeting, but was still not convinced that deviation from CCRA testing would 
improve the security of these products. He reques ted that India provide a detailed explanation of 
the possible security improvements  of its alternative approach. 
2.69.  The representative of the European Union asked India whether the date of entry into force 
of the security testing requirements would be further postponed; the EU understood that the 
current date of entry into force was 1 April 2016. The EU also understood that the relevant testing 
infrastructure was not ready hitherto and that the Indian Ministry of Communications and 
Information Technology was therefore considering further postponement. He sought confirmation 
that pending entry into force of the new requirements, the status quo would continue to be applied 
and therefore foreign test results would continue to be accepted and suppliers would be allowed to 
self-certify their products. The EU reiterated its query regarding the value added of the new 
requirements for mandatory in-country testing and questioned whether such requirements would 
contribute to enhanced security. He appreciate d India's previous explanations regarding the 
reliance on and leveraging of test results and certificates based on the common criteria standards 
and issued under the CCRA as well as based on the Third Generation Partnership Project (3GPP) 
standards on telecom network equipment. The EU sustained the view that any Indian specific 
requirements would increase costs without enhancing security and urged India to rely on 
international standards and global practices. EU industry continued to request more clarity on the 
new security testing requirements; in particular, that testing should be based on product type 
testing instead of batch testing, as the latter would arguably create a bottleneck on importation 
creating supply change disruption. The EU urge d India to provide flexibility under the new 
requirements for companies with a proven track record, and deemed that when they have 
demonstrated the ability to self-certify products  through adequately accredited and competent in-
house laboratories, they should be allowed to do so under the new requirements. 
2.70.  The representative of the United States expressed gratitude for the postponement of the 
1 April 2016 entry into force date, and requested th at India formally notify this postponement 
through an addendum. The US also continued to request that India accept internationally accepted 
standards, such as 3GPP, and recognition of co nformity assessment through the CCRA. She also 
requested that India notify to the TBT Committee the proposed revised telecommunications security regulations of 30 May 2011, and provide Members and interested stakeholders adequate 
opportunity to comment. She continued to urge India to remove the in-country testing 
requirement from the proposed regulation because it was unnecessary, costly, more trade-restrictive than necessary, and contradicted the national treatment principle of conformity 
assessment bodies. The US asked India to provide the US TBT Enquiry Point with its risk analysis 
upon which the in-country testing requirement is based. Finally, she said security testing that 
would potentially compromise companies' proprietary information, such as source code or other intellectual property, would potentially discourage companies from selling high-quality 
telecommunications equipment on the Indian market. In turn, this would limit Indian service 
provider access to critical network products and components. 
2.71.  The representative of Japan supported the statements of other Members and confirmed 
Japan's continued interest and concern. She recalled India's statement at the June 2015 
Committee meeting that "IT product testing carried out against the CC process would be leveraged without necessarily repeat testing. However, some a dditional test could be conducted if required in 
the interest of nation".
7 Japan again requested that India clarify the concrete meaning of "interest 
of nation". Japan asked India to ensure its telecom regulations do not impede market access for foreign industries. She also requested that India confirm the date of entry into force of the in-country security testing requirements. 
2.72.  The representative of India reported no change in the status of this policy since the 
November 2015 Committee meeting and therefore invited interested delegations to refer to India's 
intervention at that meeting.8 He also informed the Committee that the date of entry into force of 
the in-country security testing through authorized and certified labs was likely to be extended. He 
                                               
7 G/TBT/M/67, para. 2.80. 
8 G/TBT/M/66, para. 3.79. G/TBT/M/68 
 
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  stated that India had mandated security certific ation of network elements before their induction 
because telecom networks are critical infrastructure upon which other important infrastructure (e.g. power, transportation and defence) depend. India disagreed with the arguments made by some Members that security testing would potentially compromise companies' proprietary 
information such as source code and would potentially discourage them from selling high quality 
telecom equipment in India. That argument, he po inted out, seemed to suggest that in-country 
security testing would tend to compromise compan ies' proprietary information, whereas security 
testing in a foreign lab would not. Regarding the feasibility of using 3GPP standards, India noted 
that 3GPP by its own admission was in the process of developing security standards and had taken up the MME as the first element, for which standards had not yet come out. India took note of the additional questions raised at this meeting, an d said these would be forwarded to capital for 
response.  
2.2.3.4  China – Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA ) 1999 Regulation on 
commercial encryption products and its on-goi ng revision and the Multi-Level Protection 
Scheme (MLPS) (IMS ID 294) 
2.73.  The representative of Canada was concerned that China's regime for regulating the 
information technology sector was overly burdensome and restrictive to international trade. While 
Canada recognized that China was seeking to address security concerns, avoiding duplication of conformity testing by recognizing foreign accreditation would significantly reduce the burden on industry, representing a net benefit for all parties. China's approach to regulating the IT security 
sector appeared to lack coordination and ran counter to well-established international best 
practices in the sector.  
2.74.  The representative of the European Union continued to be concerned about China's overall 
regulatory approach in the IT security sector; he reiterated the EU's request for an update on the 
status of the revision of the regulation on co mmercial encryption products by OSCCA. This had 
been on the agenda of the State Council for several years. Was there a more precise timeline for 
finalizing the process? And could a TBT noti fication be made of the final draft?  
2.75.  He said that the Multi-Level protection sch eme (MLPS) raised the more general question of 
what constituted "critical infrastructure"; the EU had already noted its concern about the overly extensive scope that had been given in the MLPS. Besides the MLPS, subsequently, a national 
security law had been passed according to which all key cyber infrastructure within China had to 
be secure and controllable. No definition of "sec ure and controllable" was available and it had been 
on this basis that the draft implementation guid elines concerning banking and insurance sectors 
(subject to discussion below) had been prepared. Overall this created uncertainty about what 
critical infrastructure was, and what requirements applied to companies operating such critical infrastructure and supplying equipment to networks that were defined or considered as critical 
infrastructure. In addition, in 2015, the National People's Congress had issued a first draft of a 
cyber security law that also elaborated on the notion of critical information infrastructure, operator of critical infrastructure, critical equipment for network related products for cyber security and again contained the notion of "secure and controll able". The European Union requested that this 
draft be notified under the TBT Agreement. Moreover, was a revised draft under preparation? If so, 
what was the timeline for progress on this file?  
2.76.  Regarding relevant standards, on a more positive note, the European Union had observed a 
recent opening by Technical Committee 260 (TC260) under the Standardization Administration of 
China. This technical committee dealt with information security standards and had recently allowed participation of foreign companies in China, including wholly foreign-owned companies. 
Nevertheless, this opening had been managed in a way that did not allow all potentially interested 
foreign companies to apply for being included so the EU requested that TC260 reopen the call for interest in order for European companies to also manifest their interest and be included among the 
participants in TC260; equal treatment needed to be granted to all companies in China regarding 
participation in Chinese standardization organizations.  
2.77.  The European Union stressed the importance of enhanced international cooperation in this 
field; he said that cyber security is a global issue. It needed a general commitment to develop 
compatible regimes that enhanced security without hindering trade in commercial encryption 
products – this was in the mutual interest of all Members. G/TBT/M/68 
 
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  2.78.  The representative of Japan supported the positions set out above. Japan was closely 
following Chinese regulation in this area. Duri ng the meeting in March 2015, China had made a 
statement that "the revision of OSCCA is listed in the legislation plan and opportunity for public comment is also going to be arranged." Howeve r, China had not said anything on the current 
status of the revision for which Japan requested more information.  
2.79.  The representative of the United States supported the above interventions.  
2.80.  The representative of China said that there were no further updates to be made and 
referred Members to the minutes of previous Committee meetings.9 
2.2.3.5  Russia – Draft Technical Regulation on Alcoholic Drinks Safety, G/TBT/N/RUS/2 
(IMS ID 332) 
2.81.  The representative of the European Union recalled the explanations provided by Russia at 
the previous meeting of the Committee on the proc edure for adoption of technical regulations by 
the Eurasian Economic Union, in particular with regard to consultations within its member States, and invited Russia to update the Committee on the status and timeline for adoption and 
implementation of the draft technical regulation  on alcohol products safety, which had been 
notified in 2012. Referring to the detailed comments submitted by the EU in writing to Russia in 2013 and the discussions in subsequent meetings of the TBT Committee, the EU representative 
recalled Russia's explanation that most of the EU comments regarding wine, spirit drinks and beer 
would be taken on board in the revised draft technical regulation. However, a revised text had neither been notified under the TBT Agreement nor published. The EU requested Russia to re-
notify the revised text to the TBT Committee as it would likely include substantial changes as 
compared to the text notified in 2012. The EU also  requested that sufficient delay be provided for 
manufacturers to adapt their products to the requirements of the technical regulation. 
2.82.  The representative of Guatemala indicated her delegation's interest in following discussions 
on this issue.  2.83.  The representative of the Russian Federati on indicated that since the previous Committee 
meeting, there had been no changes to the draft,  which was being developed with the purpose of 
establishing unified requirements for commercialization of alcoholic products, both imported and 
produced domestically. Although public hearings  on the draft technical regulation had been 
completed before Russia's accession to the WTO in December 2011, all engaged stakeholders had been invited to provide comments during a 60-day pe riod, in full conformity with the provisions of 
the TBT Agreement. In May 2015, the Eurasian Ec onomic Commission had sent an amended text 
of the technical regulation to member states of the Eurasian Economic Union (EAEU), including the more recently-acceded members Armenia and Kyrgyz Republic, taking into account comments and 
suggestions of stakeholders and WTO Members. He said that concerns of WTO Members were 
being taken into account during the on-going consultation process among the member states, which had some differences of opinion about the draft.  
2.2.3.6  Korea – Regulation on Registrati on and Evaluation of Chemical Material 
(IMS ID 305) 
2.84.  The representative of the United States thanked the Republic of Korea for its receptiveness 
to stakeholder input. The US intended to maintain an ongoing, constructive dialogue that was open 
and transparent. In particular, the US had appr eciated the Ministry of the Environment (MOE) 
opening the Ministerial Decree for amendments and public comments. The US industry had 
submitted very extensive comments. However, the US was very concerned about the 16 
November 2015 MOE announcement. The announcement had moved the implementation date up 
to 1 January 2016, despite promises to consider delaying implementation. The United States was especially concerned about the new requirement that submitted information be published on the 
Internet. The US reiterated its support for a strong definition of Confidential Business Information 
(CBI) that recognized the possibility of protecting specific chemical identity, composition, and uses. 
                                               
9 G/TBT/M/67, para 2.85; G/TBT/M/66, para.3 .83; and, G/TBT/M/65/Rev.1, para. 2.68.  G/TBT/M/68 
 
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  2.85.  There seemed to be a general lack of gu idance. Even though progress had been made, the 
US was constantly faced with new challenges when the regulation changed. Because of this, US industry continued to request detailed guidance documents to assist manufacturers, importers, suppliers, and stakeholders in ensuring accurate and consistent compliance with Korea REACH (K-
REACH). For example, the US reiterated its concern that it needed much more specific guidance on 
all products that would be classified under the biocides group. The guidance documents available had not been clearly communicated to all stakeholders, and they had also changed frequently. This 
had caused uncertainty among chemical manufacturers, as well as manufacturers of products that 
used trace amounts of chemicals as inputs of production. It was important for Korea to consult stakeholders closely, openly, and transparently, if it was to minimize the trade restrictiveness of K-REACH.  
2.86.  The United States was also concerned that the guidance documents had only been 
published in Korean. As a result, many stakeholders had to have these documents translated. This decreased the time available to come into compliance. To address this challenge, the US 
suggested that these significant documents be allowed more time for public comment. In this 
respect, there was also a lot of confusion about the respective requirements of K-REACH and the 
Chemical Controls Act (CCA) – especially since there was no English translation of the CCA.  
2.87.  The representative of the United States noted that registrants, especially foreign 
manufacturers, needed time to determine the substa nces covered by the regulation, identify Only 
Representatives, establish agreements for joint registration, conduct studies, and submit the necessary information to be in compliance. Due to the constantly changing requirements and lack 
of guidance already mentioned, registrants needed  additional time to implement such compliance 
activities. For example, while companies only had 2 years to conduct the necessary studies for registration, the US needed guidance on how to submit data, types of data accepted, etc. 
Chemicals also continued to be added or removed from the toxic substances list without proper 
notice, opportunity for comment, or reasoning for the changes. 
2.88.  With respect to CBI, the US respected the legitimate government interest in allowing the 
reporting of generic chemical names, and provid ing adequate hazard information to downstream 
users. Industry stakeholders were willing to disclose this information as long as there was 
reasonable assurance that their trade secrets would not end up leaked to their market competitors – especially since their products required a substantial amount of investment in highly competitive 
markets. The US repeated its request that the MO E allow registrants to declare specific-uses CBI 
for hazardous and non-hazardous substances. Similarly to the type of substance or chemical group, should the specific use of a substance be leaked, it would communicate information to 
competitors that may know its true value.  
2.89.  With respect to Data Acceptance and Articl e 13 of the Final Presidential Decree, the United 
States asked that the MOE confirm that it would accept qualitative or quantitative structure activity 
relationship models (QSAR) and read-across techni ques in order to reduce duplicative testing. 
When such data was submitted, the US suggested  that the MOE accept the scientific expert's 
statement and not require additional evidence for the waiving or omission. The United States had 
also received reports that the implementation was not running smoothly, such as that: the Help 
Desk and Authorities were difficult to reach an d provided poor responsiveness to stakeholder 
inquiries; notifications and registrations were taking much longer than the legal targets; and some Lead Registrants were operating on their own without consulting with other co-registrants. 
2.90.  The representative of Japan also expressed concern about the "Act on Registration and 
Evaluation of Chemical Substances"– on the threshold for reporting on new chemical substances. 
Japan asked Korea to adopt an exemption scheme for new chemical substances of small volume, 
as Japan had suggested at the meeting in October 2013 and November 2015. At the last meeting 
of the Committee, Korea had said that it had simplified report procedures, by revising the 
ministerial decree so that foreign manufactures could submit the report directly to MOE, lightening the burden to industries. However, a report obligation without a minimum threshold for new 
chemical substances remained a heavy burden for industries. In the case of existing chemical 
substances, reporting was required only on chemical substances that were manufactured, i m p o r t e d  o r  s o l d  a t  1  t o n n e  o r  m o r e  p e r  y e a r .  I n  t h e  c a s e  o f  n e w  c h e m i c a l  s u b s t a n c e s ,  n o  
minimum threshold had yet been set for quantity, so even at  1 gram, new chemical substances 
would need to be reported. Moreover, although ther e would be less risk for chemical substances of 
small volume, the annual reporting requirement impo sed too great a  burden on businesses. Japan G/TBT/M/68 
 
- 18 - 
 
  requested Korea to establish a minimum threshold for reporting on new chemical substances (such 
as more than 0.1tonne per year) as other countries had. 
2.91.  The representative of Australia supported the US and Japanese statements. While Australia 
supported the objective of reporting products which contained hazardous substances so as to 
protect consumers and the environment, it was also important to ensure regulatory quality in 
terms of predictability, transparency and clarity of regulatory guidelines – as well as adequate stakeholder consultation and a need to implement adequate checks and balances to protect 
commercial-in-confidence information from registration and evaluation processes. 
2.92.  The representative of the Republic of Korea said that before implementation of the 
regulation, Korea had interacted with stakeholders of domestic and foreign companies, and 
planned to keep gathering the opinions from stakeh olders closely, openly and transparently. From 
the early stage of the enforcement of the regula tion, Korea had provided detailed guidance and 
intended to provide additional material if needed . Korea also intended to strengthen promotion and 
training activities to facilitate the use of the document by foreign companies. With respect to the 
protection of CBI, Korea was protecting it at the international level, as mentioned during last 
Committee. It was noted that QSARs and read-across techniques could be submitted as registered data under K-REACH and if these were scientifically reliable, no additional data would be required. 
2.2.3.7  Indonesia - Technical Guidelines fo r the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety, G/TBT/N/IDN/64 (IMS ID 328) 
2.93.  The representative of the European Union re quested an update on the Ministry of Industry's 
on-going review of Toy Safety Decree No. 24, announced at the November 2015 meeting, which 
had been followed up by the establishment of a working group composed of representatives of 
domestic and foreign toy manufacturers, tasked with working alongside the Ministry on the review. 
A timeline for its completion as well as any information on likely amendments to the decree were 
welcomed. He recalled the EU's two main issues of concern. Firstly, the current discriminatory 
conformity assessment procedures differentiated, wi thout justification, between imported toys and 
domestic products: while the former are subject to batch testing, the latter are subject to testing 
based on samples taken from the production li ne every six months. Secondly, concerning the 
ability for foreign manufacturers to use foreign test results in the certification process, his delegation considered that Indonesia should allow test results issued by adequately accredited 
foreign labs, namely accredited by ILAC MRA signatories, as the basis for any certification issued 
by certification bodies approved by the Indonesian  Ministry of Industry. It was hoped that these 
two aspects would be carefully considered and addressed in the context of the on-going review 
and that a TBT notification of the revised draft decree would be made at the appropriate time.  
2.94.  Concerning the current situation, Indonesia was urged to prolong the two-year grace period 
for the acceptance of foreign test results beyond its 30 April 2016 expiry date pending the review 
of Decree No. 24, and in any event to consider as a permanent solution the EU proposal to use 
foreign test results as a basis for any certification issued by certification bodies approved by the Indonesian Ministry of Industry. The EU was awar e that consideration was being given to ensuring 
alignment between the Indonesian national standard for toys and the corresponding ISO standard. 
The review would also provide for a certain automatic alignment between the national and the 
international standards, in order to avoid any di screpancy between the two. His delegation invited 
Indonesia to urgently consider amending the current testing methods for formaldehyde, which it 
deemed erroneously based on limits that applied to infant clothing rather than toys, the former 
being much stricter due to the prolonged skin co ntact with clothing. He welcomed the opportunity 
for a future bilateral with Indonesia in order to advance discussions. 
2.95.  The representative of Canada recognized th e importance of enhancing toy safety to ensure 
appropriate protection of consumers. However, his delegation considered certain aspects of 
Indonesia's toy regulatory regime considerably more restrictive than necessary and at odds with internationally recognized practices in the sector. The provisions relating to laboratory 
accreditation, testing frequency, sampling, documentation, and substance restrictions were of 
particular concern and had not been adequately addressed despite repeated interventions from other Committee Members. Canada urged Indonesia to adhere to international best practices by 
allowing ILAC signatories and properly accredited ISO 17025 laboratories to test without requiring 
additional approval by the Ministry of Industry. The differences in sampling criteria for domestic G/TBT/M/68 
 
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  products (every 6 months) and imported products (every shipment) adopted by Indonesia were 
deemed discriminatory towards imported products. Whilst his delegation recognized the difference in the volume of products to be tested, it was considered to be at odds with Indonesia's national treatment and MFN obligations. He invited Indonesia to provide additional information on the 
anticipated implementation date for the new formaldehyde test method. Currently, manufacturers 
had to conduct separate tests that were unique to the Indonesian market. Canada was also concerned that the 20ppm requirement was very close to existing feasible detection limits, making 
it difficult to conduct accurate tests, and in this light suggested that existing international 
standards and limits be used. 
2.96.  The representative of the United States  expressed concern at the lack of information 
available from the Indonesian government on the matter. Of particular concern were the 
acceptance of test results from accredited  laboratories, testing frequency, sampling, 
documentation, and substance restrictions, and the constraint of having a bilateral MRA in addition to the ILAC MRA requirements in place by the fast-approaching deadline of April 2016. In this 
regard, it invited Indonesia to ensure that the current transition period for acceptance of foreign 
lab tests would be extended until issuance of th e new regulation. She recalled her delegation's 
support of Indonesia's intentions to revise the regulation as part of President Jakowi's effort to 
reduce wait times at Indonesian ports, requesti ng an update on the status and content of the 
revisions. The US was keen to work with Indonesia in what it hoped to be a transparent revision, allowing for meaningful foreign stakeholder particip ation. The Ministry of Industry's creation of a 
Toy Industry Working Group was also welcomed. She urged Indonesia to notify the draft at an 
early enough stage to allow all stakeholders to provide comments and to allow them to be taken 
into account with adequate time for necessary ch anges to be made to the final measure. Summing 
up, she recalled her delegation's previous interv entions on the issue, hoping that the concerns 
raised would be addressed by the revisions.  
2.97.  The representative of Japan expressed her delegation's continued support for the positions 
of Canada, the United States and the European Unio n. She reported that serious delays in exports 
had been caused by a sequence of events such as sampling, testing, SNI certification and pre-
shipment inspection and in this light invited Indonesia to revise the requirements that her delegation considered to be more trade-restrictive than necessary. Regarding one particular issue of concern relating to the laboratory accreditation requirement, Japan understood that most toys 
imported to Indonesia had been tested by foreign laboratories. Regarding these toys, Japan 
considered that only using foreign laboratories located in countries with which Indonesia had an MRA and domestic laboratories would not ensure smooth and accurate testing. Japan strongly 
urged Indonesia to continue to accredit foreign laboratories located in countries not having an MRA 
with Indonesia. Could Indonesia confirm whether or not there were any countries with which Indonesia had an MRA at this stage? Japan requested an update on Indonesia's commitment in the 
November 2015 meeting to review its toy safety regulation and to provide an opportunity for 
Members to comment on the regulation. 
2.98.  The representative of Indonesia indicated that thus far there had been no further 
developments regarding the mandatory application of SNI Toys and recalled its responses in the 
June 2015 meeting.10 He flagged Indonesia's intention of conducting a review on the 
implementation of regulations on mandatory application of SNI Toys to ensure that it was running effectively and efficiently. His delegation welcomed any requests for further clarification that 
Members may have on the policy.  
2.2.3.8  India – Food Safety and Standard s Regulation – Food Labelling Requirements, 
G/TBT/N/IND/34, G/TBT/N/IND/43, G/TBT/N/IND/46 (IMS ID 298) 
2.99.  The representative of the European Unio n invited India to update the Committee on the 
latest developments regarding this measure. He fi rst raised concerns with draft Food Safety and 
Standards (Food Products Standards and Food Additives) Amendment Regulation 2015 (notified to the WTO SPS Committee under G/SPS/N/IND/108), wh ich covered a very wide range of products 
and could disrupt imports into India. His delegation believed the regulation set too restrictive 
"recommended maximum levels of additives" for use in all kinds of products. 
                                               
10 G/TBT/M/66, paragraph 3.95. G/TBT/M/68 
 
- 20 - 
 
  2.100.  He noted that the regulation did not acknowle dge that "the lack of reference to a particular 
additive or its usage in food does not imply the unsafeness or unsuitability of an additive or its usage in food", in line with the Codex General Standard for Food Additives (GSFA, Codex Stan 
192-1995). Furthermore, he said that the regulation did not take into consideration the adoption 
of standards by other international standard bodies  such as the World Vine and Wine Organization 
(OIV) or by other countries, which were set on the basis of science, of longstanding good practices, of technology needs and safety. The EU  asked India to take into consideration in the 
final version of the Regulation all comments sent by the EU and asked that India introduce a 
flexible and expeditious procedure to authorize new additives within a reasonable period of time. 
2.101.  Finally, he requested India to update the Committee on the process of amending specific 
parts of the Indian food standards in line with  Codex standards. The EU said this process was 
important to facilitate the imports of products such as olives, whole-wheat pasta, vinegar and 
mineral water, among others. 
2.102.  The representative of the United States sh ared concerns raised by the EU delegation and 
recalled her delegation's intervention from the previous meeting.11 She sought an update on the 
status of India's efforts to align domestic requirements with international standards and understood that India had expected to complete those efforts by the end of 2014. The US greatly 
appreciated the information provided by India regarding the issuance of two new SPS and TBT 
product-specific notifications on food additives and vegetable oils, respectively. She requested India to provide a timeline for the publication of the amended FSSAI Rules. The US was of the view that wholesale bags of agricultural commodities  should not need be labelled with consumer-
focused information upon arrival at Indian ports. This should not be deemed as a rectifiable 
labelling defect in the first place given that the end use of the product is not direct consumption. The US respectfully requested India to consider  the end use of the product as the determinant 
factor when assessing compliance with labelling requirements.  
2.103.  The representative of Australia reiterated her delegation's concern on India's delays in 
harmonizing with Codex standards and associated la belling requirements as this work was due to 
be finalized in 2014. She asked India to advise Members on when the process of harmonization 
with Codex standards would be finalized and expre ssed Australia's willingness to continue working 
with India towards completion of the Codex harm onization process. She recalled that India had 
agreed at the June 2015 TBT Committee meeting12 to forward queries from WTO Members to New 
Delhi and to send a response to interested dele gations in due course. As no response had been 
received, her delegation asked if India could ad vise on when a response would be provided.  
2.104.  The representative of Guatemala said that her delegation shared the legitimate objective 
of informing the Indian population about the food that they were eating, including information on 
ingredients therein, but Guatemala also shared the concerns which had been expressed by other 
Members and would follow the development of this discussion very closely.  
2.105.  The representative of India expressed gratitude to the other delegations for their continued 
interest in the matter and informed the Committee that the FSSAI had harmonized its standards 
on food additives with Codex, with effect from 23 December 2015. He said that his delegation took note of the new concerns and suggestions such as  that concerning labelling of wholesale food 
items, which would be forwarded to the capital for consideration. 
2.2.3.9  European Union – Draft Implementi ng Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for th e application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentati on of certain wine sector products, 
G/TBT/N/EU/246, G/TBT/N/EU/246/Add.1 (IMS ID 345) 
2.106.  The representative of the United States recalled previous concerns expressed at the last 
meeting: "…that this measure would severely restrict the ability of non-EC wine to use common or 
descriptive and commercially valuable terms, on the grounds that those terms are traditional to European wines."
13 This was a particular concern because some of these terms did not have a 
                                               
11 G/TBT/M/67, para 2.100. 
12 G/TBT/M/66, para 3.102. 
13 G/TBT/M/67, para. 2.107. G/TBT/M/68 
 
- 21 - 
 
  common definition across EU member States. Furthermore, she recalled her delegation's concerns 
about the enforcement of the regulation and ho w the Commission would ensure consistency of 
interpretation across EU member States,14 and requested an update from the EU on the status of 
the application that was submitted by the US wine industry four years ago. 
2.107.  She held that the continued lack of transparency and fulsome response to repeated 
requests and interventions on behalf of the US was unacceptable and considered this issue as a serious trade concern that negatively impacted bila teral trade without resolution for years. Indeed, 
many US suppliers were still unable to ship thei r products to the EU. The US failed to see why 
several other countries had already been granted permission to use various traditional terms, while other countries including the US continued to wait on their applications. The ongoing delay by the Commission continued to erode market access for US wines in EU member States, and the 
US asked what was the basis for the extend ed delay in approving US applications. 
2.108.  On the question of approving the applications, the US had been hearing for months that 
the EU would imminently make more information available about the status of the traditional 
terms of applications, as well as changes within the EU to the application review process. The US 
expressed disappointment that there was still no news on how this process was moving forward, as communicated by the EU at their most recent bilateral meeting. The US delegation said the 
consistent delay and lack of information about the process was completely unacceptable. While the 
US valued its close trading relationship with the EU, the sustained lack of responsiveness, transparency, and timely review of these pending applications put a strain on the ability of the US to work productively with the EU. 
2.109.  The representative of Argentina shared  the concern expressed by the United States 
regarding the modification of the EU wine regi me. Since the current amendment process was not 
transparent, there was no information whatsoever on  the regime that is to replace the current one 
and on how it will affect pending applications for registration such as those relating to the 
traditional terms "Reserva" and "Gran Reserva". In  this regard, Argentina asked whether the EU 
planned to consult interested third countries, whether it would conduct a public assessment of the 
impact of the proposal, and whether a tentative date had been set for circulation of the legislative 
reform proposal. 
2.110.  The representative of the European Union thanked the other Members for the interest in 
the EU's requirements on wine products. As noted at the last TBT Committee meeting, an internal 
assessment on traditional terms had been carried out within the EU involving stakeholders and 
experts from EU member States (in accordance with Article 114(3) of Regulation n° 1308/2013 
establishing a common organization of the markets in agricultural products).15 The alignment and 
simplification of wine labelling provisions and traditional terms rules, as well as the pending 
applications for traditional terms, were still under consideration in the context of the general reflection on the marketing rules for all agricu ltural products. Therefore, no proposals on 
traditional terms were expected shortly. The EU would continue to make the possible and 
necessary efforts to simplify its current policy on protection of traditional terms and their indication on the labels of wines, taking into account trade partners' concerns. The concerns raised by the other Members were noted and he said these would be considered when carrying out the complex 
simplification exercise. Finally, he informed that the handling of the pending applications (whether 
from EU member States or third countries) would be part of this process, and also expressed the EU's openness to hold bilateral discussion with trade partners at expert level. 
2.2.3.10  Chile - Proposed amendment to th e Food Health Regulations, Supreme Decree 
No. 977/96, G/TBT/N/CHL/219, G/TBT/N/ CHL/219/Add.1, G/TBT/N/CHL/221, 
G/TBT/N/CHL/282 (IMS ID 370) 
2.111.  The representative of Canada reiterated his delegation's concerns with this measure. He 
appreciated Chile's responses (from August 2015) to the concerns raised by several Members in 
the previous Committee meetings, and expressed Ca nada's support for the objective of promoting 
healthy dietary choices and reducing obesity and related non-communicable diseases. 
Nevertheless, Canada encouraged Chile to consider less trade-restrictive measures. His delegation 
was concerned that the regulations published on 26 June 2015 deviated from international 
                                               
14 G/TBT/M/46, paras. 310-311. 
15 G/TBT/M/67, para. 2.110. G/TBT/M/68 
 
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  standards, may not be based on scientific evidence, and may be more trade restrictive than 
necessary. He suggested that nutrient content limits based on actual serving sizes normally consumed at one sitting could provide an effective way of meeting the policy objective. 
2.112.  The representative of Mexico recalled concerns on Chile's Food Health Regulations, 
Supreme Decree No. 977/96, notified to WTO Members as a draft technical regulation on 
22 August 2014, in document G/TBT/N/CHL/282, and on its amendment, Decree No. 13 dated 
16 April 2015, which was circulated to WTO Members on 9 July 2015, as document 
G/TBT/N/CHL/282/Add.1. On 27 August 2015, Ch ile notified the replies to the comments 
submitted during the public consultation on this technical regulation. She noted that this concern had first been raised at the TBT Committee meeting of 6-7 March 2013 and had been reiterated on several occasions, and also noted that Mexico's previous statements had been circulated to 
Members.
16 
2.113.  Mexico elaborated several specific concerns. First, although the measure had 
characteristics of a technical regulation as provided for in Annex 1 to the TBT Agreement, Mexico 
considered that Chile had failed to comply with the transparency obligation set forth in Article 2.9 
of the TBT Agreement, preventing Committee Members from submitting comments. Second, Mexico considered that Chile may be contravening principles of the TBT Agreement, specifically the 
need to base technical regulations on international standards, as stipulated in Article 2 of the TBT 
Agreement, since these provisions were not consistent with the General Guidelines on Claims of the Codex Alimentarius (CAC/GL 1 1979, point 3.5). 
2.114.  Third, Mexico considered that every food possessed inherent nutritional characteristics, 
and no food could therefore be characterized as "good" or "bad" in relation to its nutritional 
content. The provisions of the amendment to the Re gulations, specifically the provision relating to 
the label "HIGH IN" (fats, sodium, sugar or calories), could arouse fear in consumers by leading 
them to assume that non-communicable diseases such as obesity are caused by the consumption 
of specific foods. Fourth, as already pointed ou t by Mexico on previous occasions, the Codex 
Guidelines on Nutrition Labelling stated that labelling "should not lead consumers to believe that 
there is exact quantitative knowledge of what indi viduals should eat in order to maintain health, 
but rather to convey an understanding of the quan tity of nutrients contained in the product", given 
that a "more exact quantitative delineation for individuals is not valid because there is no meaningful way in which knowledge about individual requirements can be used in labelling". Fifth, 
in light of the principle of proportionality established in Article 2.2 of the TBT Agreement, Mexico 
was of the view that the most recently notified measure required sound scientific and technical substantiation to ensure that the proposed la bel did not become more trade restrictive than 
necessary for pursuing the legitimate objective of Chile. 
2.115.  Sixth, the Food Health Regulations also stipulated that "foods or food products whose 
nutritional composition comprises energy, sodium, sugars or saturated fats in amounts higher than 
those specified in Table No. 1 of Article 120 bis, may not be advertised in the media or channels of 
communication, irrespective of location, that targ ets minors aged under 14 [...]". Mexico noted 
that this prohibition on advertising did not appl y to foods containing energy, sugars, sodium, or 
saturated fats in a natural form. Seventh, Mexico requested Chile to provide the scientific or 
technical evidence justifying the prohibition on advertising to minors aged 14 and under, as well as 
the exception established for products whose energy , sugar, sodium or saturated fat content is in 
a natural form. There were products on the market with a higher sugar, sodium or saturated fat 
content than natural foods; therefore, if the aim was for children below the age of 14 to refrain 
from eating foods high in sugars, sodium or sa turated fats, this requirement did not meet the 
legitimate objective of the Regulations. 
2.116.  Mexico requested that Chile submit the pr ovisions that had given rise to the amendments 
to the Food Health Regulations to public consultation. In addition, Mexico asked Chile to harmonize the requirements set forth in the Regulations with  the General Guidelines on Claims of the Codex 
Alimentarius (CAC/GL 1 1979, point 3.5). Mexico fu rther requested Chile to provide an explanation 
of the scientific or technical evidence supporting the use of labels bearing the term "HIGH IN", 
considering the legitimate objective pursued by the amendment to the Food Health Regulations. 
Finally, Mexico asked that Chile modify the classification of foods on the basis of a distinction 
                                               
16 G/TBT/W/406 (18-19 March 2015 TBT Committee meeting), G/TBT/W/428 (4-6 November 2015 TBT 
Committee meeting). G/TBT/M/68 
 
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  between liquid and solid foods and, in accordance with international parameters, to classify foods 
according to the category to which they belong. 
2.117.  The representative of the United States strongly supported Chile's public health objectives 
of reducing obesity and related non-communicable diseases, and appreciated the extensive 
bilateral engagement on Chile's nutrition labelling regulation and its associated WTO notifications. 
The US appreciated the inclusion of an implementa tion review mechanism in the final measure, but 
asked Chile to delay implementation in order to fully review and consider comments received from 
foreign stakeholders in the context of this mechanism. As raised in past meetings, the US 
encouraged Chile to evaluate the impact of the "warning" element of the icons, and the use of 100 gram and 100 ml portion sizes. She reiterated the US request for a two-year implementation window from the date that the final regulation was published in order to allow industry 
reformulation and compliance with the labellin g requirements based on nutrient thresholds. 
2.118.  In addition, the US emphasized five outstanding issues: first, whether concentrated fruit 
juice would be considered "sugar" and unflavoured sy rups used in baking such as corn syrup would 
be considered "syrup". Second, she asked how Chile  would verify the addition of sodium, saturated 
fats, sugar, and honey, amongst others. Chile indicated that, in addition to the ingredient list, it would consider technical specifications of the product or its ingredients, audits of production 
methods, chemical laboratory analysis, and possi ble other means. Third, she asked whether foods 
such as whole grain breakfast cereals, whole milk, yogurt, cooking oils, and cheese would be exempt from the measure. Fourth, the US requ ested Chile to develop guidance or otherwise 
provide transparency on these issues and to consul t with all stakeholders in doing so. Fifth, she 
asked Chile to confirm whether voluntary claims would be allowed when the claim was not related 
to a nutrient that exceeds the relevant threshold. 
2.119.  The representative of Guatemala reiterat ed concerns regarding the measure expressed in 
past Committee meetings. Her delegation shared Chile's concerns about childhood obesity and 
expressed deference to Chile's right to adopt appropriate measures to address these issues. Nevertheless, it was not clear to Guatemala how the establishment of nutrient content thresholds 
and labelling requirements could potentially reduce obesity since the level of a nutrient ingested by 
an individual depended on the habits of consumers. She said that any foodstuff had inherent nutritional characteristics and that it was not possible to decide what was good or bad solely on the basis of nutritional content. While her delegati on appreciated that Chile took into account some 
concerns that had been raised by other Members, she noted that the Chilean delegation did not 
answer Guatemala's question on how the measure would reduce obesity and why the measure as designed did not constitute an unnecessary obstacle  to trade. Guatemala said the measure should 
be based on Codex standards, and be based on science. 
2.120.  Guatemala requested consultations with the Chilean Ministry of Health of Chile regarding 
the conditions for labelling and asked whether the measure would enter into force on 26 July 2017. 
Guatemala also asked if there is a timeframe for products which were already on the market and if 
additional time would be given to these products to align with the labelling requirements. Finally, Guatemala expressed concerned about the converge nce problem in labelling requirements in the 
region. Her delegation did not believe that Codex standards were being taken into consideration, 
and that each Member was adopting different national measures to protect the health of their 
respective population, with the consequence of obstructing trade in foodstuffs. 
2.121.  The representative of Costa Rica supported the concerns voiced by Canada and Mexico. 
Costa Rica continued to question the compatibility of the measure with the provisions of the TBT 
Agreement, especially regarding the lack of scientific evidence to substantiate these measures as stated in the Codex Alimentarius. Costa Rica urged the Chilean government to adopt necessary 
measures to safeguard the legitimate objectives of protecting health, while taking these concerns 
into consideration. 
2.122.  The representative of Chile thanked Memb ers for their interest in the modification of 
Decree 977 of 1996 by the Chilean Ministry of He alth, Health Regulations Food, to fulfil the 
mandate set out in the Act 20,606 on Nutritional Composition of Food and Advertising. He first 
recalled Chile's statement at the November 2015 TBT Committee meeting.17 He stated that Chile 
had complied with the obligations of the TBT Agreem ent in terms of transparency by notifying to 
                                               
17 G/TBT/M/67, para. 2.116 G/TBT/M/68 
 
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  the WTO, as well as complying with recommendations of the Committee by responding to 
comments received from trading partners, and informing the general public via the website of the Ministry of Health. With respect to advertising, Chile doubted that such measures were covered by 
the TBT Agreement as stated on previous occasion s. Statistics showed that the prevalence of 
childhood obesity and related non-communicable diseases had increased in Chile, which is the 
reason why it had enacted this measure together with other related measures over time. Finally, he expressed Chile's willingness to hold consulta tions with concerned Members who needed further 
information regarding implementation of the measur e, bilaterally, in the Committee or elsewhere. 
2.2.3.11  India - Electronics and Informat ion Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IND/47 G/TBT/N/IND/47/Add.1, 
G/TBT/IND/47/Add.1/Corr.1 (IMS ID 367) 
2.123.  The representative of the Republic of Korea thanked India for the numerous bilateral 
meetings and their efforts to improve the Compulsory Registration Order on secondary cell 
batteries. While many of Korea's issues had been  resolved, Korean companies continued to have 
difficulties in complying with the regulation. First, as a member of the IECEE CB Scheme, India's 
certification bodies already had MRAs with other Members and should therefore accept test reports approved under the Scheme. Second, the Bureau of  Indian Standards (BIS) certification was only 
valid for two years whereas others, such as Chinese Taipei's BSMI and Korea's KC certification 
were valid for five years. In addi tion, it took approximately six months to receive BIS certification. 
Therefore Korea requested for a one- or two-year extension of BIS certification. 
2.124.  The representative of Canada said exporters continued to face challenges in gaining access 
to the Indian market due to delays in registration and testing. Recognition of foreign conformity 
assessment bodies accredited by signatories to the ILAC and IAF MLAs to test and certify to India's 
regulatory requirements would minimize the negati ve impact on companies wishing to export to 
India. This would also provide assurance to In dia that the recognized conformity assessment 
bodies were competent, and by allowing accredit ed foreign conformity assessment bodies to test 
and certify to India's regulatory requirements, th ey would reduce testing costs and allow exporters 
to bring their products to the Indian market more quickly. Canada also queried the rationale of the 
BIS requirement for an MRA in order to accept test results from non-BIS labs, even if they were ILAC, IAF accredited and produced test reports following the IECEE-CB scheme. Given the substantive amendments to the Order, Canada asked that the measure be notified to the TBT 
Committee and looked forward to continuing to work with India to address the outstanding issues.  
2.125.  The representative of the European Unio n associated his delegation with the comments 
made by Korea and Canada. He thanked India for providing some clarification regarding the 
various categories of products covered and for the recently notified addenda concerning changes in 
the date of entry into force. However, the EU continued to have concerns with the registration procedure and reiterated its request to consider a single registration for multiple factories where 
identical products were manufactured under the control of the same manufacturer, as had been 
reflected in the minutes of the previous two TBT Committee meetings. India had indicated that this 
matter was under active consideration by the Department of Electronics and Information Technology of the Ministry of Communication and IT . An update on this active consideration, and a 
shortening of the processing time for incoming applications, would be appreciated. On the issue of 
testing reports, the status quo was that India accepted test reports issued under the IEC CB scheme or by laboratories accredited to international standard ISO/IEC 17025 by an ILAC MRA 
signatory, but only for safety critical components. He reiterated the request for India to consider 
improving reliance on the IEC CB scheme as well as ILAC MRA so as to increase acceptability of test reports issued under the CB scheme by CABs accredited by an ILAC MRA signatory beyond the 
safety critical components. The EU also requested more flexibility concerning the validity of test 
reports which was currently limited to 90 days which was considered by industry to be overly restrictive.  
2.126.  The representative of the United States reiterated her delegation's appreciation for India's 
continued engagement with industry and the expansion of the list of products under the Highly 
Specialized Equipment (HSE) exemption. She urge d India to further broaden the list so as to 
include all products that were not destined for the commercial market such as servers, storage 
systems, and large-scale printing machines which were installed, operated, and maintained by 
trained professionals and therefore did not pose  any risk to the average consumer. The US 
encouraged India to modify FAQ No.18 to indi cate that HSE shall stand exempted from the G/TBT/M/68 
 
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  Compulsory Registration Order (CRO) provided that it is intended for sale to medium to large 
enterprises and requires the medium to large enterprise to order directly from the product vendor or through Business Partners representing the vendor, and was not available through consumer retail channels. 
2.127.  She asked that India explain why it was necessary for foreign products to be retested 
against a BIS standard when they had already been tested against an identical international safety standard (IEC 60950-1). On the MRA requirement, she asked why an additional MRA was 
necessary when, as a member of the IECEE CB Sc heme, India should provide reciprocal approval 
of tests performed at IECEE CB accredited labs ou tside of India. On the acceptance of lab test 
results, she reiterated the request that appointed labs should only require a product sample to conduct verification testing if the labs could not resolve a suspected non-compliance issue from 
information exchanges between the Certification Body issuing the CB Test report and/or the 
manufacturer. This would be of great assistance to manufacturers and allow India's labs to improve testing. The US also had concerns with the expiration of test reports after 90 days as this 
was not in line with international norms. As no other national certification agency had expiration 
dates on their test reports, she asked why India re quired this deviation from international practice. 
She questioned what risk factors this addressed and requested that India remove this constraint. 
Concerning brand-based certification, the US appreciated the shift to this type of certification. 
However the change was still insufficient in addressing concerns as the CRO process required registration of each factory rather than brand owner registration. The US asked that the BIS recognize global supply chain best practices whereby the brand owners were responsible for the 
safety and compliance of their products rather than individual factories, as laid out in IECEE 
Definitions, Edition 2.0 2014-06-04. The brand owners  had greater authority to act in a situation of 
an alleged or suspected safety issue and determ ine whether there was a risk to the consumer, 
whereas a factory could only understand the product design to the extent allowed under contract. 
They rarely had the engineering resources to conduct a safety analysis on their own. Making the brand owners responsible would therefore enable In dia to align the CRO with global supply chain 
models and reduce redundant testing and timelines. Concerning the CRO product registration and 
renewal process, the US requested that the product registration process at BIS be automated and a clear timeline from application submission to final approval be established. This would allow industry to comply with BIS standards and ensure  that consumers had access to the most recent 
ICT products. Finally, the US encouraged India to continue its collaborative consultations with 
stakeholders so as to bring its safety testing regime into line with international best practices.  
2.128.  The representative of India thanked delegations for their continued interest in the measure 
and invited Members to consult the minutes of the previous TBT Committee meeting as many of 
the issues raised (e.g. reliance of CB Scheme, recognition of foreign labs and accredited conformity assessment bodies, expiry period of test  results and validity period of registration) had 
already been responded to in that meeting.  On more recent developments, he informed the 
Committee that on 30 November 2015, the Government of India had further extended the implementation period of the Compulsory Registration Scheme for some products, such as for sealed secondary cells and batteries to 1 June 2016. India was making progress in harmonizing 
national standards with international standards and while it had done so in the case of IEC 60950-
1, there were requirements to deviate in some areas like the use of Indian plugs and issues such as environmental conditions. On the suggestion to automate the registration process, he said that 
this system had always been automated and the process time for registration was also clearly 
defined. Finally he assured Members that all th e comments and suggestions would be conveyed to 
capital for consideration. 
2.2.3.12  Peru - Act to Promote Healthy  Eating Among Children and Adolescents 
(IMS ID 383) 
2.129.  The representative of the United States ex pressed support for Peru's objectives of reducing 
obesity and other NCDs, however the US was conc erned that certain aspects of this measure 
lacked clarity on implementation and could unnecessarily disrupt trade. She appreciated the 
extensive bilateral engagement on the proposed regulation to implement the Healthy Eating Act 
and urged Peru to notify the Supreme Decree 007-201-SA as a revised notification of 
G/TBT/N/PERU/59, given that this Decree significantly differed from the originally notified text. 
She informed the Committee that the US had submitted a request through the Peru TBT Enquiry Point for notification of this measure on 24 April 2015. She asked whether Peru was still 
considering a re-notification and whether there was a timeframe for its submission. G/TBT/M/68 
 
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  2.130.  The US also reiterated substantive concerns about the technical parameters for labelling 
enacted in the Supreme Decree 007-2015-SA. First, the US was concerned that nutrition labelling was only mandatory when either a voluntary claim was made or the consumption warning was required. Nutrition panels could be regarded by consumers in a negative way if only the least 
healthy foods were required to display nutrition in formation. In this regard, the US asked whether 
Peru considered other less trade-restrictive alternatives. Second, the consumption warning expressed in this measure would apply to significantly more foods and non-alcoholic beverages 
than those specified in WTO notification G/TBT/N/ PER/59. The US requested Peru to explain why it 
decided to expand the scope of the foods subjec t to advisory nutrient labelling. Third, the 
proposed threshold for the amount of sodium and saturated fats that would require a consumption 
warning and nutrients facts panel was significantly lower than the Codex guidance. The US asked 
Peru to clarify the process for the establishmen t of these proposed limits, and the reasons for 
preferring them over the Codex nutrient reference values (NRV). Fourth, she asked Peru to provide clarification of the basis by which it established the per portion nutrient content limit for sugar, and 
how Peru determined that an across-the-boar d nutrient threshold based on 100 gram or 100 
millilitre amounts of large categories of food s was appropriate for the Peruvian population. 
2.131.  The representative of Mexico expressed concerns with regard to Law No. 30021, "Law to 
Promote Healthy Eating Among Children and Adolescents", published on 17 May 2013 in the 
Official Journal El Peruano. This concern was first presented to the Committee in June 2014, and had been reiterated on subsequent occasions. This matter had also been the subject of bilateral dialogue with Peru, which Mexico appreciated. Pe ru had indicated that the regulatory provisions 
that would implement the Law had not yet been issued. However, Supreme Decree No. 
007/15/SA, "Regulations establishing the technical parameters for sugar, sodium and saturated fat content in processed foods and non-alcoholic beverages", had been published on 18 April 2015, 
approving technical parameters in respect of the content of certain substances (sugar, salt and 
saturated fats) in processed foods. Specifically, the "Final Additional Provision" stipulated that these new provisions "shall enter into force within the time frame determined by the Regulations 
implementing Law No. 30021", and  Mexico therefore asked for an update on the progress on their 
preparation. 
2.132.  Mexico reiterated a number of previously expressed concerns. First, Mexico acknowledged 
the right of Peru to safeguard its legitimate intere sts, in this case, protecting its population from 
non-communicable diseases. It must be pointed out, however, that all public policies must have a 
scientific basis or be in accordance with international parameters in order to fulfil international commitments. Second, Law No. 30021 had characteristi cs of a technical regulation as provided for 
in Annex 1 to the TBT Agreement. Mexico consid ered that Peru had failed to comply with the 
transparency obligation set forth in Article 2.9 of  the TBT Agreement, preventing Mexico and other 
Members from submitting comments for consideration in the course of its preparation. 
2.133.  Third, Mexico considered that Peru may be contravening principles of the TBT Agreement, 
specifically the need to base technical regulations on international standards, as stipulated in Article 2.4 of the TBT Agreement, since the provis ions of the Law were not based on the General 
Guidelines on Claims of the Codex Alimentari us (CAC/GL 1 1979, point 3.5). Fourth, Mexico 
considered that every food has inherent nutritional characteristics, as each person has different 
nutritional needs, and no food can therefore be characterized as "good" or "bad" in relation to its nutritional content. Therefore, use of the term "HIGH" on food labels could arouse fear in 
consumers by leading them to assume that non communicable diseases such as obesity were 
caused by the consumption of specific foods. Fi fth, Mexico noted that the Codex Guidelines on 
Nutrition Labelling state that the label "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 nutrien ts contained in the product", given that a "more 
exact quantitative delineation for individuals is not valid because there is no meaningful way in 
which knowledge about individual requirements can be used in labelling". 
2.134.  Mexico therefore urged Peru to provide an update on the current status of preparation of 
the measures that will implement the provisions on labelling contained in Law No. 30021, as well as the time frame for entry into force of the technical parameters for processed foods and non-
alcoholic beverages, as set forth in Supreme Decree No. 007 2015 SA. Finally, in preparing these 
measures, she requested that Peru provide a time frame in which to receive and consider comments from other Members. G/TBT/M/68 
 
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  2.135.  The representative of Guatemala reiterated  concerns expressed in previous interventions 
and said that her delegation was looking forward to Peru's response to its comments. She said that 
Guatemala had submitted comments within the appropriate time-frame of the public consultation and had raised questions in the Committee. She argued that the impact of eating certain foods did 
not depend on the pre-established values of f ood but rather depended on the consumer. As a 
result, she expressed Guatemala's belief that the measure at issue was not supported by scientific or technical basis and expressed concern regarding the technical parameters of Supreme Decree 
007-2015-SA, which differed from the previously no tified measure. She emphasised Article 3 of 
the measure which referred to recommendations of the WHO and the Pan American Health Organization, in particular in terms of the application of the Profile Modelling Tool (PMT) of the act which contains parameters for measuring foodstuffs and beverages and their content in terms of 
sodium, saturated fat and sugar. Guatemala asked for further information on the measure and 
clarification on how Peru used the PMT. Finall y, Guatemala remained concerned about the new 
changes in the labelling requirements at the regi onal level, and expressed Guatemala's willingness 
to discuss the measure bilaterally. 
2.136.  The representative of Canada reiterated concerns about the lack of information regarding 
this measure. Canada supported Peru's objective of reducing obesity and other non-communicable 
diseases. However, his delegation was concerned that this measure potentially deviated from 
international standards and would be more trade restrictive than necessary. Noting that Peru's final technical parameters for sugar, salt and fat levels in food had been published on 18 April 2015, Canada asked whether it had considered a less trade-restrictive alternative to achieve its 
policy goals. He suggested that nutrient content limits based on actual serving sizes normally 
consumed at one sitting would provide an effective way of meeting the policy objective. Such an approach would be implemented in a manner consistent with international standards. Canada 
requested an update on when these regulations would come into force and encouraged Peru to 
p r o v i d e  a n  a d e q u a t e  t r a n s i t i o n  p e r i o d  t o  a l l o w  i n d u s t r y  t i m e  t o  a d j u s t  t o  a n y  n e w  l a b e l l i n g  requirements. 
2.137.  The representative of Costa Rica reiterated his delegation's concerns on this measure, and 
asked for an update on its implementation. 
2.138.  The representative of Peru stressed the importance of reducing levels of obesity and other 
non-communicable diseases amongst the vulnerable population, particularly children and 
adolescents, objectives this measure sought to a ddress. He stated that the legislative amendments 
adopted had the legitimate objective of protecting  public health as had been recognized by the 
other Members in their interventions.  He repo rted that Peru was working on a complementary 
measure which would allow implementation of the Law 3-21 with a multi-sectoral commission 
which aimed to establish and implement provisions on nutrition, overweight and obesity issues. He said that it was difficult to say when this law would come into force in the short term; however, 
Peru recognized that businesses needed a reasonable  length of time to allow them to adapt their 
production to new requirements. Finally, Peru reiterated its commitment to avoid creating unnecessary barriers to trade. 
2.2.3.13  European Union — Revised Proposal  for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment (IMS ID 393) 
2.139.  The representative of Argentina reiterated his delegation's concern with the revision 
process being undertaking by the European Union to define its criteria for identifying substances 
with endocrine disrupting properties. Argentina su pported the need to provide stronger protection 
for human health and the environment so long as this was done in way that was consistent with WTO Agreements, in particular the SPS and TBT Agreements. Argentina referred to the European 
Commission's statement with respect to the judgment of the EU General Court (Sweden vs the 
Commission) and underscored the Commission's reference on the fact that impact assessment was an essential tool to guide a future decision on identifying endocrine disruptors. He said that taking a rapid decision to achieve early finalization of the impact assessment could adversely affect the 
resulting legislative proposal, undermining its quality and scope. Argentina was concerned that in 
accelerating the roadmap deadlines, comment s submitted by the international scientific 
community, industry and third countries would not be taken into account in the final proposal. 
2.140.  Therefore, in order to avoid unnecessary ba rriers to trade, the future regulation to be 
adopted by the EU should rely on an effective risk assessment taking into the account the actual G/TBT/M/68 
 
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  exposure to risk, including the possibility of establishing maximum residue limits under the import 
tolerance approach, instead of classifications based on hazard identification, which will ultimately 
determine a default MRL detection level of 0.01 ppm for substances covered under that approach. He argued that a measure based solely on an approach that considers only the hazard and not the 
risk of its likelihood and severity, may lead to disproportionate and unnecessarily trade-restrictive 
measures that were inconsistent with WTO obligations. Moreover, he reiterated that the European Food Safety Agency (EFSA) had already stated that substances with endocrine disrupting 
properties could be dealt with on the basis of a risk assessment approach and not just a hazard 
identification approach. 
2.141.  Argentina requested that any measure adopted be applied in a transparent and non-
discriminatory manner, and not constitute an unnecessary restriction on international trade. He 
stated that the measure at issue would clearl y have extensive commercial and socio-economic 
impact, affecting countries that produce raw materials, particularly developing countries. Finally, Argentina requested the EU to provide the sched uled timetable for publication of the impact 
assessment, as well as any changes to the calendar included in the regulatory proposal 
presentation and whether the possibility of further public consultation was envisaged. 
2.142.  The representative of Canada reiterated concerns with the EU's proposed approach for the 
categorization of compounds as Endocrine Disruptors. Canada continued to be concerned with the 
implementation of a hazard-based approach for the regulation of plant protection products, as this 
could unnecessarily restrict trade. By focusing on the mere possibility of a hazard instead of the 
actual risk, a chemical found to pose an acceptable risk under the EU's own risk assessment 
process may not be authorized under the hazard-based approach. He noted that hazard 
characterization was an important step in the scientific risk assessment framework. However, it was also imperative that these adverse effects be put into context of the level of potential human 
and environmental exposure, based on conditions of use. Canada was interested in learning more 
about the EU's current approach and any evidence that would demonstrate how the EU's deviation from internationally accepted practices was safer for human health. Furthermore, he argued that 
using hazard-based screening criteria for the categorization of compounds as endocrine disruptors 
could deprive EU and Canadian producers and farmers from taking advantage of valuable and safe crop protection products. Canada was concerned that the options presented in the EU's Roadmap did not include a risk-based approach. 
2.143.  Canada said that the EU's hazard-based approach could unnecessarily disrupt trade in food 
and feed without appreciably increasing the safety of consumers in their markets. Canada strongly 
believed the EU's regulatory shift only served to undermine international trade in agriculture and 
contravened the fundamental principle of the WTO SPS agreement, which was to base measures 
on scientific risk assessments and to not maintain them without scientific justification. As the EU was a global leader in agricultural trade, Canada urged the EU to play a leadership role in 
demonstrating to other trading nations that it was both possible, and important, to use sound, 
science-based and trade-consistent measures to protect the safety of consumers. Canada was actively monitoring these measures, and sought further clarifications on the interplay between Regulation 1107/2009 (Placing of plant protection  products on the market and repealing council 
directives 79/117/EEC and 91/414/EEC) and Regu lation 396/200 (Maximum Residue Limits of 
Pesticides in or on Food and Feed of Plant and An imal Origin). Canada asked the EU to reconsider 
the hazard-based approach which would not make consumers safer, but would have a negative, 
unnecessary and unjustified impact on trade. Finally, Canada requested that the EU provide 
information on the upcoming impact assessments to be released in the summer.  
2.144.  The representation of the United States st rongly supported strengthening public health and 
environmental protection by properly identifying,  understanding, and regulating the use of plant 
protection and biocidal products that may have endocrine-disrupting properties. She emphasized that for several years the United States had been raising concerns with the EU process for identifying endocrine disruptors. For example in  January 2015, the US had submitted extensive 
comments regarding the possible impact of this dr aft proposal on billions of dollars of trade 
worldwide. The US remained concerned that a large number of substances, and the products that contain them, could be affected by the new categories and could be withdrawn from the EU market 
as a result. Given the high level of uncertainty that this issue was causing for global trade, the US 
urged the EU to adopt an evidence-based approach  that considered risk from exposure. The US 
also asked the EU to provide timely updates on the status of this issue and to follow a process G/TBT/M/68 
 
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  which would allow for broad public participation. The US looked forward to working with the EU to 
ensure that the approach followed was risk-bas ed and the least trade restrictive possible.  
2.145.  The representative of Colombia shared the concerns expressed by other Members with the 
proposal by the EU to introduce categorization of  compounds of Endocrine Disruptors under the EC 
07/2009. Colombia also shared the legitimate concerns of the EU with regard to the possible 
effects on public health of these substances which can affect the endocrine system. However, Colombia stated that any measure adopted by the EU needed to respect WTO agreements. He 
noted that the EU proposal to regulate products (commonly called agrochemicals) should be based 
on risk assessment and techniques established by competent international authorities to consider the level of danger involved. Instead, the EU approach meant that any agricultural product containing minimum risk levels or that had been treated by any of the endocrine disruptors falling 
into these categories would not be allowed into the EU market. 
2.146.  According the calculations undertaken by various authorities, it was estimated that the 
impact on Latin American products to the EU mark et could be significant. Considering only one of 
seven categories of products which would be included in this risk assessment according to the 
2009 regulation, potentially up to 1.3 billion Euros in trade per year could be affected. Colombia believed that it was important for the EU to undertake a regulatory impact assessment to look at 
the possible consequences of this regulation. He expressed his delegation's concern that it would 
be very difficult to limit the number of components falling into each category  for defining endocrine 
disruptors and that many substances, synthetic or natural, can interact with the endocrine system, including phytochemicals, alkaloids such as caffeine, foods, medicines, cosmetic products and 
plastic products. For this reason, Colombia was of the view that the regulation should be 
accompanied by a regulatory impact assessment taking into consideration scientific evidence, processes and production methods, relevant insp ection methods, testing, and ecological and 
environmental standards, in order to avoid barriers to trade.  
2.147.  The representative of Chile supported the interventions of other Members. He shared the 
view that a full analysis should be carried out wi th regard to the risk based on scientific evidence, 
and that any measure adopted by the EU should be based on such evidence, and accompanied by 
a full impact assessment on the implications of the measure. 
2.148.  The representative of the European Union informed the Committee – as explained in 
previous meetings – that the European Commission would be carrying out a comprehensive impact 
assessment analysing different options on defining  criteria for the identification of endocrine 
disruptors and their corresponding health, socio- economic and environmental effects in the EU 
legislation. Detailed information about the impact assessment, including the analytical report of 
the responses to the public consultation of 24 July 2015, was published on the website of DG 
Health and Food Safety. With regard to the impact assessment, he stated that the Commission had organized several roundtables and a public conference on 1 June 2015 informing EU member 
States, MEPs, third countries and stakeholders about the on-going impact assessment. He also 
said that a technical meeting on the Joint Resear ch Centre Methodology held on 6 November 2015 
supported the impact assessment and estimated which chemicals would fall under the different criteria to identify endocrine disruptors as outlined in the roadmap. He said that the impact 
assessment was now entering its final stage and the Commission would present proposals for the 
new criteria to identify endocrine disruptors in the EU's plant protection products regulation and biocidal products regulation before summer 2016. He informed the Committee that the EU would 
notify the new proposal to the WTO, in full transparency, to allow interested parties' comments to 
be taken into account. 
2.2.3.14  Indonesia – Ministry of Health Re gulation 30/2013 on the inclusion of sugar, 
salt and fat content information, as well as  health messages on the label of processed 
foods, G/TBT/N/IDN/84, G/TBT/ N/IDN/84/Add.1 (IMS ID 389) 
2.149.  The representative of the European Unio n reiterated concerns with Regulation 30/2013, 
which introduced a mandatory health warning message on sugar, salt and fat content on the label 
of all processed food products. The EU noted that Regulation 30/2013 had been amended by 
Regulation 63/2015, which postponed the date of application until 2019. However, Regulation 63/2015 did not alter the substance of Regulation 30/2013. He asked for information about the 
results of any study undertaken by the Indonesian Ministry of Health to determine types of food 
included in the high risk and low risk classifica tions. The EU looked forward to the issuing of G/TBT/M/68 
 
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  implementing provisions for this Regulation addressing product coverage in detail, as well as of 
guidelines including further details. He requested that both measures be notified to the TBT Committee while still in draft form, so that Members were provided with sufficient time for comments. 
2.150.  The EU reiterated its previous request for clarification and detailed information on three 
issues: (i) how nutrition information and related heal th warnings would be placed on the label, the 
testing methods for nutrition levels and the conduct of risk assessment related to non-
communicable diseases (NCDs); (ii) the possibility for Indonesia to accept test results issued by 
laboratories other than the ones accredited by the Indonesian National Accreditation Body (KAN) or by other competent institutions having a Mutu al Recognition Arrangement (MRA) with KAN; and 
(iii) the possibility to place stickers after importat ion, and before the placement of the products on 
the market in Indonesia, for instance, in customs warehouses, as an alternative to labelling in the 
country of origin.  
2.151.  The representative of Canada expressed su pport for Indonesia's objective of reducing the 
risk of non-communicable diseases and apprecia ted Indonesia's transparency on this issue. 
Nevertheless, Canada was concerned about the potential trade impact of Indonesia's regulatory proposals requiring labels of all processed and fast foods to bear a health warning regarding 
content of sugar, salt and fat. She appreciated that the entry into force of the measures was 
delayed until 2019, and hoped this delay would give Indonesia further opportunity to take into account Members' concerns. She recalled come of these concerns, for example, whether Indonesia's requirement to include a message identifying certain risks in relation to the quantity of 
sugar, fat and salt ingested per day would be necessary to achieve Indonesia's policy objective. 
Canada requested Indonesia to provide scientific evidence supporting the use of these measures and to provide reference to the international standards on which the measure was based. In 
addition, Canada requested that Indonesia provide, in due course, an update on the acceptance of 
test results from accredited laboratories that use internationally recognized and appropriate methodologies. Finally, Canada encouraged Indo nesia to notify further amendments to this 
regulation. 
2.152.  The representative of Guatemala expressed support for the legitimate objective of 
informing the population about foods and their ingredients. Nevertheless, she said that Guatemala 
shared concerns expressed by other Members and would follow the development of the discussions 
on this measure carefully. 
2.153.  The representative of Australia recognized Indonesia's right to implement measures which 
would provide consumers with information to make appropriate dietary choices and reduce the risk 
of diet-related non-communicable diseases. However, she stressed that such measures should be 
no more trade restrictive than necessary to achieve legitimate objectives. Australia sought further clarification on why Indonesia considered a mandatory health message on processed foods was 
necessary to achieve Indonesia's public health and consumer information objectives. Finally, 
Australia reminded Indonesia of the obligation to  notify the WTO of any proposed regulatory 
changes and to take into account comments received from Members. 
2.154.  The representative of Indonesia responded to concerns raised by other Members. 
Indonesia's full statement is contained in document G/TBT/W/445. 2.2.3.15  Ecuador – Resolution No. 116 of th e Foreign Trade Committee of Ecuador of 19 
November 2013 and Technical Regulation of the Ecuadorian Standardization Institute 
RTE INEN 022 on the labelling of proc essed and packaged food products, 
G/TBT/N/ECU/19, G/TBT/N/ECU/19/Add.1–Add.10 (IMS ID 411) 
2.155.  The representative of Canada expressed concern with regard to the burdensome nature of 
the conformity assessment procedures for this regulation. Canada had received industry 
complaints on the requirement to provide a verification checklist to demonstrate compliance on a per shipment basis. Adequate data management, coupled with periodic audits, was a less burdensome method of achieving the same objective. Canada was of the view that the measure 
was already having an impact on trade and was more trade restrictive than necessary. The process 
of providing samples to an Ecuadorian Accreditation Organization, in addition to self-certification, suggested this conformity assessment was duplicat ive, redundant and trade restrictive. Finally, G/TBT/M/68 
 
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  Canada asked Ecuador to explain this measure, and what efforts were undertaken to improve the 
product certification process.  
2.156.  The representative of the European Union shared Canada's concerns with RTE INEN 022 on 
the labelling of processed and packaged food  products. He recalled the EU's previous 
interventions18, in particular regarding the lack of proportionality of the measure, its departure 
from Codex guidelines and the use of "high in" warnings. 
2.157.  The representative of Mexico limited her remarks to Ecuadorian Standardization Institute 
Technical Regulation (RTE INEN) No. 022 on th e labelling of processed and packaged food 
products. She noted that this concern had first been raised at the 5-6 November 2014 TBT Committee meeting, and reiterated at the March and June 2015 Committee meetings. At the 4-6 November 2015 TBT Committee meeting, Mexico once again expressed concern regarding this 
measure.
19 Mexico remained concerned about notifica tion G/TBT/N/ECU/19/Add.11, circulated on 
18 December 2015, which related to Corrigendum 1 to the second revision of RTE INEN No. 022. Mexico still had concerns in this respect, as the amendments only provided that labelling was 
mandatory not only on the front but also on the back of the packaging. 
2.158.  Mexico appreciated the bilateral dialogue held with Ecuador to address this issue. She 
noted communications at Vice-ministerial level, which enabled Mexico to reiterate its concerns with 
regard to the labelling scheme set out in RTE INEN No. 022, and to request evidence justifying 
how the measures meets its legitimate objective. In this respect, Ecuador had informed Mexico that it based the Regulation on the results of th e National Health and Nutrition Survey (ENSANUT), 
taking into account consumer health, state disease reduction policies and the PAHO Plan of Action 
for the Prevention of Obesity in Children and Ad olescents, which advocated the establishment by 
countries of requirements "for front of package labe lling that allow for quick and easy identification 
of energy dense nutrient poor products and sugar sweetened beverages, which take into 
consideration Codex norms". Mexico was also informed about the reference to non-caloric 
sweetener content, based on United States Fo od and Drug Administration (FDA) provisions, 
without any explanation, however, as to the technical or scientific basis justifying a reference to 
the transgenic content of foods. 
2.159.  Mexico reiterated a number of specific concerns. First, although the regulatory provision 
forming the basis of the draft revision of PR TE INEN No. 022 (Sanitary Regulations for the 
Labelling of Processed Foods for Human Consumption) had characteristics of a technical regulation 
as provided for in Annex 1 to the TBT Agreement, Mexico considered that Peru had failed to 
comply with the transparency obligation set forth in Article 2.9 of the TBT Agreement, preventing 
Mexico and other interested Members from submit ting comments. Second, Mexico considered that 
the system of colour-coded charts may contravene the provisions of Article 2.4 of the TBT 
Agreement, as it was not based on international standards such as the General Standard for the Labellin g of Pre Packaged Foods of the Codex Alim entarius (CODEX STAN 1 1985, point 2). 
2.160.  Third, it should be emphasized that the General Standard for the Labellin g of Pre Packaged 
Foods of the Codex Alimentarius did not stipulate a system of colour-coded charts (showing "high", "medium" and "low" concentration of total fats, sugars and salts); scientific evidence was therefore requested to demonstrate that the system complied with Article 2.2 of the TBT Agreement, by not 
constituting the least-restrictive alternative necessary to fulfil the desired legitimate objective. She 
reiterated Mexico's concern that this system could arouse fear in the consumer. Fourth, scientific or technical evidence is also requested to justify the requirement of transgenic content 
specification on the label. Fifth, Mexico considered that the measures on advertising, which 
prohibited the use of images of real or fictitious persons and animals in labelling, may be contrary to the provisions of Article 20 of the WTO Ag reement on Trade Related Aspects of Intellectual 
Property Rights, as they may unjustifiably encumb er the use of a brand name in the course of 
trading. 
2.161.  Finally, she reiterated Mexico's previous requests to Ecuador with respect to this measure. 
First, Ecuador was requested to notify the Sanitary Regulations for the Labelling of Processed 
Foods for Human Consumption, in accordance with the provisions of the TBT Agreement, so that 
comments and observations on the regulations could be submitted. Second, Mexico requested that 
                                               
18 G/TBT/M/67, para. 1.148. 
19 G/TBT/W/430. G/TBT/M/68 
 
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  PRTE INEN No. 022 be amended so that concepts  such as "food" and "nutritional claim" would 
coincide with the provisions of the Codex Alimentarius, and that the difference between "food" and "processed food" be eliminated. Third, Mexico asked for an explanation of the justification and scientific evidence for using the system of colour-c oded charts specifying the "high", "medium" or 
"low" concentration of three components: total fats, sugars and salts. Mexico also asked Ecuador 
to provide information on the results achieved by this system. Fourth, Mexico requested that justification be provided or, if appropriate, consideration be given to eliminating the requirement of 
including the term "transgenic" on the label, in case  of transgenic content. Fifth, Mexico asked that 
the restrictions on advertising in labelling be reconsidered. 
2.162.  The representative of Guatemala reiterated concerns regarding the lack of transparency in 
terms of complying with TBT Agreement notification obligations and the lack of public consultation. 
Guatemala said the measure had a negative impact on trade, and was more restrictive than 
necessary. Although Guatemala did share the legiti mate objective of combatting obesity, she was 
not convinced that the regulation would achieve this  objective, and said it would rather create an 
unnecessary obstacle to trade. She recalled that Ecuador had stated at the last meeting that the 
labelling requirements were in line with the PAHO provisions and the Codex guidelines. Guatemala asked Ecuador to share scientific information on  which the measure was based. She expressed 
concern about the changes in labelling requirements in the region, and stressed that Codex 
guidelines were not being taken into consideration. As a result, a range of different measures were being taken by Members to safeguard the legitimate  objective of protecting public health, which 
was creating obstacles to trade.  
2.163.  The representative of Costa Rica echoed concerns expressed by other delegations, in 
particular with regard to the lack of scienti fic evidence and the departure from relevant 
international standards. She asked Ecuador to consider less trade-restrictive measures which were 
aligned with the principles of the TBT Agreement. 
2.164.  The representative of Ecuador noted that Resolution No. 116 was related to certification 
requirements corresponding to an administrative measure. She said that RTE INEN No. 022, in 
force since 23 December 2014, was based on the 2012 Ministry of Health's study on health and 
nutrition, which concluded that Ecuador's epidemiological profile reflected an upward trend in the number of non-communicable diseases across the population, regardless of age or socio-economic status. She noted that Ecuador also encouraged other strategies with regard to nutrition such as 
promoting maximum levels of fat and sugar and encouraging exercise. She said that the 
requirements of foodstuff labelling was in line with Article 12 of the TBT Agreement to guarantee 
the right of consumers to relevant, clear and precise information about the content and 
characteristics of the foodstuffs in order to make informed choices. In addition, Ecuador was 
complying with paragraph 3.3.1 of the PAHO "Actio n Plan for the Prevention Obesity in Children 
and Adolescents", which established rules that take into consideration Codex norms in place for 
front-of-package labelling that allow for quick and easy identification of energy-dense, nutrient-
poor products and sugar-sweetened beverages. She confirmed that the comments made by Members with respect to the procedures for assessing compliance with RTE INEN No. 022 and for obtaining sanitary registration had been reassesse d by both INEN (the Ecuadorian Standardization 
Service) and ARCSA (Sanitary Regulation and Control Agency) and that the processing time had 
been substantially reduced. With regard to sweet eners, although some had been considered as 
safe by the FDA, Ecuador decided to inform consumers given that some suffer from metabolic 
difficulties, unable to metabolize sweeteners. Ec uador informed the Committee that RTE INEN No. 
022 was being properly implemented, and that both  industry and importers were complying with 
the regulation. Finally, she noted that the refe rence standards for RTE INEN No. 022 were adapted 
to Codex standards. 
2.2.3.16  Russia - Safety of products fo r children and adolescents, G/TBT/N/RUS/29 
(IMS ID 418) 
2.165.  The representative of the European Union requested further information on whether the 
amendments notified under G/TBT/N/RUS/29 had been  adopted and, if so, when they would enter 
into force. In addition, the EU wished to receive the final adopted text once available. 
2.166.  The representative of the Russian Fede ration thanked the EU for comments on draft 
amendments to the Customs Union's Technical Regulation on "Safety of products for children and G/TBT/M/68 
 
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  adolescents." Recalling Russia's statement from the previous meeting20,  h e  s a i d  t h a t  t h e  
"Regulation on the development, adoption, amendmen t and cancellation of technical regulations of 
the Eurasian Economic Union" did not impose time limits for internal EAEU member state discussions and that the exact adoption date of the amendments could not be predicted. Russia 
would continue to share information with Members on the ongoing process. 
2.2.3.17  India – Labelling Regulations for Canola Oil (IMS ID 413) 2.167.  The representative of Canada reiterated concerns relating to the Food Safety and 
Standards Authority of India's (FSSAI) advisory re-affirming the position that the product in 
question must be labelled and marketed as "Imported Rapeseed - Low Erucic Acid Oil (Canola Oil)", which directly affected exports, marketing and sales of canola oil in India. Canada was concerned that the regulation was more trade restrictive than necessary to achieve India's 
legitimate objective and strongly encouraged India to accept "canola oil" as a synonym for 
"rapeseed - low erucic acid oil," consistent with India's past practice, the existing Codex standard for naming of vegetable oils, as well as with India's application of the Codex standard to other 
vegetable oils (i.e. maize and arachis). Noting that the Supreme Court of India had ruled against 
the FSSAI's interpretation of the regulation and that the decision had been sent to the Bombay 
High Court for final ruling, he asked when a rulin g on the issue was expected. Canada encouraged 
India to consider an alternative measure regarding labelling requirements for canola oil that did 
not unnecessarily create a barrier to trade.  
2.168.  The representative of Australia said that her delegation remained concerned that India's 
Food Products and Food Additives Regulation only  allowed canola oil to be used as a secondary 
term, which was not consistent with the Codex Standard for named vegetable oils, which 
permitted the use of synonym descriptors for "rapeseed oil", including canola oil. This was an unnecessary labelling burden for Australian exporters of refined canola oil to India while it was 
their understanding that the term canola oil was often used to describe domestic products that 
were available for local sale in India. 
2.169.  The representative of India replied that there had been no change in the regulatory status 
since the previous meeting held in June 2015 and referred interested delegations to India's 
intervention from that meeting.21 
2.2.3.18  Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Al coholic Beverages, issued under B.E. 
G/TBT/N/THA/437 (IMS ID 427) 
2.170.  The representative of the European Union reiterated his delegation's concerns regarding 
the Regulation on Criteria, Procedures and Conditions for Labels of Alcoholic Beverages (B.E. 
2558/2015), which had entered into force on 22 Ap ril 2015 and was applicable as from 19 October 
2015. As expressed in previous Committee meetings22, the EU welcomed the technical guidelines 
on the implementation of the Regulation issu ed by Thailand on 30 September 2015 and also 
acknowledged Thailand's reply to the EU letter of 13 October 2015 expressing concerns on the 
strict labelling requirements. In December 2015, the EU had submitted further comments on the Regulation, focusing in particular on the following points: the need for definitions to comply with international standards (i.e. "label" and "container"); the lack of clarity of the provisions relating to 
the messages permitted on the label, which might le ad to inconsistent interpretation by economic 
operators; the potential risks that the Regulation might bring to specific terms commonly used in the EU linked to the ageing or maturation process,  to the conditions, quality or characteristics of 
the product; the need to allow the sale of all products covered by the Regulation already placed on 
the market until exhaustion of stocks; and the ne ed to clarify the scope of the exemption related 
to alcoholic beverages manufactured or imported for export and not for commercial purposes in 
Thailand. The EU sought confirmation of information received that the Thai Regulation and the 
technical guidelines would be amended in the near future in order to clarify their provisions and that enforcement would be delayed. The EU also requested an update on the outcome of considerations on graphic health warnings and invi ted Thailand to notify any draft proposal to the 
TBT Committee so that Members had the opportunity to comment on it. 
                                               
20 G/TBT/M/67, paras. 2.153-2.154. 
21 G/TBT/M/66, para 3.167. 
22 G/TBT/M/67, paras. 2.158-2.159; G/TBT/M/66, paras. 3.171-3.172. G/TBT/M/68 
 
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  2.171.  The representative of the United States said that her delegation supported Thailand's 
efforts to address its valid public safety and health concerns related to excessive alcohol 
consumption but requested the opportunity for further consultations to address these concerns without unnecessarily restricting trade. The US was disappointed with Thailand's continual lack of 
responsiveness to questions on this measure as it was still unclear what was, and was not allowed 
on labels and how this measure was being enforced. The US had not received a response to questions submitted to Thailand via the WTO comment process, during the previous three TBT 
Committee meetings
23 and also bilaterally. As stated pr eviously, the lack of enforcement 
procedures, the lack of clarity on how labels would be determined to "directly or indirectly persuade consumption or make claims on the benefit or quality of an alcoholic beverage", and the lack of definition for terms such as "immoral" and "exaggerated statements" were all very 
troubling, as also indicated by other Members. The long-promised technical guidelines had been 
expected to answer these questions, but the guidel ines recently published failed to provide further 
clarity on the requirements, without which it was impossible for companies to comply with the 
regulation. The US and its alcoholic beverage industry were very concerned that a significant 
amount of trade would be disrupted as a result of the pending implementation. Furthermore, basic 
questions as to the scientific basis and rationale for the measure had still not been answered. The 
Thai government had previously alluded to scientific studies that had informed this policy, but had 
not yet responded to requests to provide that study. She asked that Thailand provide the scientific evidence it referenced as well as clarifications to questions posed as soon as possible. The US was planning to monitor the impact of Thailand's requirements on US alcoholic beverage exports and 
was wondering whether Thailand was considering an evaluation of the regulation after 18 
months. If so, Thailand was invited to explain the evaluation process and whether evaluation results would be shared with trading partners. The US continued to have serious concerns that this 
measure unnecessarily restricted trade and looked forward to deeper engagement with Thailand 
on this issue. 
2.172.  The representative of Canada thanked Thailand for the meeting held that day with several 
delegations to go through some of the joint issues raised. Canada also welcomed new 
developments regarding Thailand's regulations on alcohol, as his delegation had serious concerns 
with the existing version as explained during previous TBT Committee meetings24 and through a 
letter sent to Thailand's Enquiry Point in May 201 4. He understood that the new regulations would 
be developed in consultation with relevant stakeholders including importers. Canada looked 
forward to reviewing and commenting on this proce ss and hoped that the results would be in line 
with the TBT Agreement and would take into account the fact that Canadian wine labels were not 
intended to appeal to children or promote irresponsible alcohol consumption. Similarly, Canada 
had not witnessed any correlation between the sale of products labelled with sport figures or cartoon-like images with an uptake in youth or irresponsible drinking. Canada hoped that new 
regulations would be clear and reduce uncertainty for wine and spirits exporters. Canada was also 
interested in knowing more about the use of graphic warning labels, which Thailand was considering. 
2.173.  The representative of Mexico indicated that this concern had first been raised at the 
June 2014 TBT Committee meeting and then reiterated during several subsequent meetings. 
Mexico's statements from the March and November 2015 TBT Committee meetings had been circulated on 11 May 2015 and 19 January 2016 in documents G/TBT/W/408 and G/TBT/W/431, 
respectively. Mexico's concerns related to Thailand's notification of the date of adoption and entry 
into force of the "Notification of the Alcoholic Beverages Control, Re: Rules, Procedures and Condition for Labels of Alcoholic Beverage s" in document G/SPS/N/THA/221/Add.1 of 
15 April 2015 and also to notifications in documents G/TBT/N/THA/437 and 
G/TBT/N/THA/437/Add.1, the latter of which was notified on 27 April 2015, regarding the adoption and entry into force (on 22 April 2015) of the draf t notification of the Alcohol Control Committee, 
Department of Disease Control, under the title "Notification of the Alcoholic Beverages Control, 
Regarding Rules, Procedure and Condition for Labels of Alcoholic Beverages". A few days earlier, 
Mexico had received an update on ongoing discussions within the Thai Government concerning the content of the measure and its consistency with international commitments at the World Trade 
Organization and had been told informally that efforts were under way to promote the consistency 
of the measure with the WTO principles, specifically as regards technical barriers to trade. Mexico 
                                               
23 G/TBT/M/67, paras. 2.163-2.164; G/TBT/M/66, paras. 3.173. 
24 G/TBT/M/67, paras. 2.161-2.162; G/TBT/M/66, paras. 3.168-3.169. G/TBT/M/68 
 
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  welcomed an update from Thailand in this respect and asked whether they could confirm the 
informal update received. 
2.174.  The representative of Guatemala said that her delegation supported efforts to protect 
consumer health and acknowledged the legitimate objective that Thailand was pursuing to reduce 
the level of consumption of alcohol among its population. However, Guatemala was not convinced 
that the measure establishing certain criteria with regard to labelling requirements for alcoholic beverages would be effective in reducing consumption. Guatemala thanked Thailand for the 
detailed explanation, including scientific information, which had led Thailand to conclude that the 
measure in question would indeed reduce the consumption of alcoholic beverages without being more trade restrictive than necessary to achieve its legitimate objective. However, the prohibitions referred to not only endangered the acknowledgement  of the quality of certain products but could 
also undermine registered intellectual property rights. Guatemala looked forward to receiving 
further information from Thailand and was available for bilateral discussions if necessary. 
2.175.  The representative of New Zealand thanked Thailand for the meeting held that day and 
acknowledged and supported Thailand's right to introduce new regulations to address this specific 
public health concern. However, as previously raised, New Zealand was concerned that the new labelling requirements were unnecessarily trade re strictive and unclear. She joined the delegations 
of the US and Canada in seeking confirmation on in dications by the Thai Ministry of Public Health 
that the regulation would be amended to address these concerns. New Zealand thanked Thailand for the guidelines that had been published in September but remained concerned that the regulation was still subject to and open to interpretation, which might lead to uncertainty for 
manufacturers and importers and have a disproportionate impact on trade. In particular, she 
sought further clarification around terms such as cartoon and on what constituted overstating of the properties, benefits or quality of a product.  Furthermore, she sought information on whether 
there was an appeal process. New Zealand encouraged  the Thai Ministry of Public Health to settle 
outstanding questions on this regulation and give n that the guidelines on implementation were 
only published at the end of September, requested that the transitional grace period be extended 
in order to provide industry with sufficient time  to ensure that their products could meet this 
regulation. She also sought an update on whethe r Thailand was intending to introduce mandatory 
graphic health warnings on alcohol labels and if so , when the draft regulation would be notified to 
the WTO. 
2.176.  The representative of South Africa support ed the statements and trade concerns raised by 
other delegations and recalled its st atement from the previous meeting.25 South Africa had also 
sent comments to Thailand, asking for certain clarif ications on the regulation but unfortunately had 
not received any response thus far. Therefore,  South Africa requested that Thailand provide 
responses to their questions as well as any updates or revisions to the regulation. 
2.177.  The representative of Japan said that his delegation continued to have concerns, similar to 
those already raised by other delegations, regardin g the regulation and its guidelines notified on 
28 March 2014 (G/TBT/N/THA/437) and 30 September 2015 (G/TBT/N/THA/437/Add.1), respectively. Japan understood the intention of Thailand to restrict false, exaggerated or 
overstating messages on alcoholic beverages; however, prohibiting accurate information would be 
more trade restrictive than necessary to fulfill a legitimate objective. Therefore, Japan hoped that 
Thailand would take comments from Japan and other Members into consideration and reconsider the examples listed in the guideline. 
2.178.  The representative of Chile echoed the co ncerns expressed by other delegations and also 
thanked Thailand for the meeting held that day. He hoped that they would be able to continue 
working together to support Thailand in pursui ng their public policy objectives and adopting 
measures which were proportionate and which did not impose unnecessary barriers to trade. He 
welcomed the fact that there might be some amen dments to the current measure, even though it 
was not quite clear what form these would take. He also indicated Chile's interest in the status of proposed graphic health warning on alcohol labels. 
2.179.  The representative of Australia said that  they understood from talking to industry in 
Bangkok that the Ministry of Public Health (MoPH) intended to draft amendments to clarify the 
current alcohol labelling and implementing guidance document and sought confirmation that this 
                                               
25 G/TBT/M/67, paras. 2.167-2.168. G/TBT/M/68 
 
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  was the case. Clarification of the guidance documents would be greatly appreciated. Australian 
exporters were keen to work with the Thai Government and their importers to comply with the new requirements. She requested that the Thai government submit an official translation of the technical guidance to the TBT Committee in  one of the official WTO languages. 
2.180.  The representative of Thailand thanked delegations for their comments and continued 
interest on this measure and indicated that all comments would be forwarded to the Department of 
Disease Control, Ministry of Public Health, for consideration.  
2.2.3.19  Ecuador – Draft Technical Regula tion of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 189: "Labelling of  Alcoholic Beverages", G/TBT/N/ECU/243 
(IMS ID 433) 
2.181.  The representative of the European Union recalled his delegation's concerns about 
Technical Regulation 189 on the labelling of alcoholic beverages, already expressed in previous 
Committee meetings26, in particular on (i) the obligation to state the name of the importer in the 
front label, (ii) the requirement that the labelling of alcoholic products be done in the country of 
origin, not allowing labelling or relabeling in a primary customs area, and (iii) the need to undergo 
certification by a conformity assessment body in order to verify compliance with labelling requirements. In November 2015, Ecuador had informed the Committee that they were still in the 
process of analyzing the comments received from Members and the EU wished to know the status 
of this process. The EU was looking forward to receiving a reply to the comments they had 
submitted on 1 July 2014. The EU also sought clarification on the relation between the proposed technical regulation and resolution SENAE DGN 2013 0300 RE. 
2.182.  The representative of the United States supported other Members' interventions and raised 
concerns, particularly with Ecuador's requiremen t that the name of the importer of alcoholic 
beverages be placed on the exported product in the country of origin, with no flexibility for 
placement in customs bonded warehouses via the use of supplementary labels (stickers). During 
the previous TBT Committee meeting, Ecuador had no ted that it was suspending this regulation, 
which would be deeply appreciated. The United  States requested that Ecuador confirm the 
suspension through a notification to the WTO and also asked for an update on Ecuador's efforts to 
align the suspension with customs regulations. 
2.183.  The representative of Mexico reiterated her delegation's concerns with respect to 
Ecuadorian Draft Technical Regulation No. 189, "Lab elling of Alcoholic Beverages", notified to WTO 
Members in document G/TBT/N/ECU/243, on which concerns had been first raised at the 
November 2014 TBT Committee meeting and thereafter at the March, June and November 2015 meetings.
27 One of Mexico's main requests was that the requirement for labelling in the country of 
origin with the name of the importer in Ecuador be eliminated or made more flexible so that 
elements that were necessary solely for marketing purposes in Ecuador did not have to appear on the label at the point of origin of the product. It was important to have scientific and technical 
justification for the labelling requirement in light of the legitimate objective of the measure. Mexico 
had also requested that the definition of Tequila, as contained in Ecuadorian Technical Standard NTE INEN No. 338, be adjusted so that it did not run counter to the definition in Mexican Official Standard NOM-006-SCFI-2012. Alternatively, Mexico had asked for the procedure to follow in 
order to request Ecuador to make this amendment and was willing to work with Ecuador on this 
point. Mexico requested an update regarding the issuance of the final version of Technical Regulation RTE INEN No. 189 since they had been informed that the formal adoption process had 
been suspended pending the review of Ecuadorian technical regulations relating to alcoholic 
beverages. Mexico also requested further details on the other requirements on Mexican industry for importing into Ecuador, as regards the labelling at origin provisions laid down in Resolution 
SANAE-DGN-2013-0300-RE on labelling of alcoholic beverages.  
2.184.  The representative of Canada said that his delegation remained concerned that Ecuador's 
customs regulation (SENAE-DGN-2013-0300-RE), first published in their official registry No. 86 on 
23 September 2013, along with the related technical regulation notified on 8 April 2014, were 
more trade restrictive than necessary when it came to labelling requirements. Ecuador's 
requirement that the labelling of products be done in the country of origin was a concern for 
                                               
26 G/TBT/M/67 para. 2.174. 
27 Mexico's statement from the November 2015 meeting is available in document G/TBT/W/432.  G/TBT/M/68 
 
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  Canada. Standard practice in the internationally traded spirits industry was to apply, in the country 
of production, generic front labels providing mandatory information. All country-specific information was then affixed on the back or secondary label in customs bonded warehouses located in the importing country. Ecuador had indi cated at previous TBT Committee meetings that 
the competent authorities were looking at revising the measure in view of the comments received. 
He invited Ecuador to provide an update on wh ether the comments had been taken into account 
and on whether Ecuador would be notify ing any amendments to the regulation. 
2.185.  The representative of Chile echoed the co ncerns expressed by the US and the EU on the 
regulation on the labelling of alcoholic beverages and indicated that Chile was also awaiting 
responses to its comments. 
2.186.  The representative of Guatemala said that  her delegation recognized the importance of 
reducing alcohol consumption levels but questioned whether the regulation in question was based 
on evidence demonstrating that it would in fact reduce consumption without being more trade restrictive than necessary in order to achieve this legitimate objective. Guatemala would follow 
closely the discussions on this measure. 
2.187.  The representative of Ecuador said that dr aft regulation INEN 189 on labelling of alcoholic 
beverages had been notified in 2014 and that its entry into force remained suspended until the 
completion of the revisions of Ecuadorian Technical Regulation 33 on labelling of alcoholic 
beverages, INEN 338 on alcoholic beverage definitions and other standards and requirements for alcoholic beverages. These standards would be open  for public consultation shortly and would then 
be considered for approval. 
2.2.3.20  China – Regulations for the Supervis ion and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022, G/TBT/N/CHN/1023, 
G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026, G/TBT/N/CHN/1029 
(IMS ID 428) 
2.188.  The representative of Canada understood that China had made a number of commitments 
on certain aspects of the above-mentioned regula tion. Canada welcomed these new developments 
but remained concerned about other important aspect s of the regulation and on the general lack of 
clarity and transparency regarding the measure. Canada continued to be concerned at China's Medical Device Registration Fee Schedule that had been published on 27 May 2015. This new fee schedule had been put into force without any notification to the WTO, failing to give Members a 
"reasonable interval between the publication of requirements concerning conformity assessment 
procedures and their entry into force", as per Members' obligation under the TBT Agreement. As had been already mentioned at the November 2015 TBT Committee meeting, Canada was 
concerned with China's approach of combining registration fees with on-site inspection fees for 
foreign manufacturers. Further, Canada continued to be concerned about the lack of transparency regarding the registration fees for domestic products which were to be levied by China's provinces. 
In order to enhance transparency, Canada would be grateful if China could publish the on-site 
inspection fees separately from the registration fees for foreign manufacturers. In addition, could 
China publish the registration fees to be levied by China's provinces on domestic manufacturers? 
Canada strongly suggested that China separate the registration fees with on-site inspection fees 
for foreign manufacturers so that it was clear what manufacturers were being charged, and for 
which services. This was important to ensure that a) the registration fees conformed with China's WTO national treatment obligations, and b) the on-site inspection fees corresponded to 
international averages.  
2.189.  With regards to the accelerated service being offered by the CFDA to fast-track 
applications for drugs and medical devices, Canada understood that foreign drugs and medical 
devices considered "innovative" could be eligible for fast-track evaluation and that China had also 
made efforts to accept more submissions. Canada welcomed China's initiative to expand the scope of the fast-track program and for providing guidelines on what constitutes an "innovative product." Nevertheless, Canada would like China to confirm this commitment and whether domestic and 
foreign firms would be charged the same fast-track fee, in line with National Treatment provisions. 
2.190.  Finally, Canada had recently taken note of China's WTO notification (G/TBT/N/CHN/1169), 
issued on 26 February 2016, regarding new registration categories of chemical drugs and would G/TBT/M/68 
 
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  appreciate receiving additional information concerning the changes. In particular, Canada would be 
interested to receive an explanation from China as to the rationale for the changes to the drug 
registration categories. Regarding registration categories 1-5 for chemical drugs, was it China's intention to charge different registration fees fo r these categories and would this result in drug 
registration fees that differ from those China announced on 27 May 2016? With respect to the 
description of the categories, how did China define "innovative drugs" and "new improved drugs"? Did "imitation of drugs" mean generic dr ugs? What was the difference between Category 3 
(Imitation of drugs that are marketed overseas but unavailable domestically) and Category 5 
(Application for the domestic marketing authorization of drugs marketed overseas)? 
2.191.  The representative of the European Union reiterated his delegation's concerns regarding 
the Chinese regulations for medical devices, no tified under G/TBT/N/CHN/1022 to 1026 and 1029, 
as sent to the Chinese authorities on 23 June 2014 and subsequently raised in the last TBT 
Committees. In particular, the EU referred to its concerns raised during the last meeting of the Committee in relation to the issue of the clinical trials required for the registration in China for 
Class II or Class III medical devices, the delays in this registration procedure, and the requirement 
to register the medical devices in the country of origin. The EU had repeatedly raised concerns with regard to the unnecessary duplicative clinical trials to be conducted in China. During the last 
meeting of the TBT Committee, China had confirmed that according to the CFDA (China Food and 
Drug Administration) Technical Guideline for Clinical Evaluation of 19 May 2015, manufacturers may present during the marketing approval of medical devices data obtained in clinical trials carried out abroad. However, in the meantime, the EU had received information according to which 
clinical trials would have to be performed for Class II and III in-vitro diagnostic medical devices on 
Chinese populations living in a Chinese mainland environment, and results of testing on Chinese populations living abroad or on non-Chinese po pulations would not be accepted. The EU asked 
China to clarify this issue. The EU also asked China to accept test reports from foreign laboratories 
accredited by accreditation bodies that were members of ILAC as an alternative to in-country electromagnetic compatibility testing in China and to exclude from the registration certificate the 
documentation on product technical requirements, which might be confidential. China was also, 
once again, requested to grant a transitional period  of three years. Further guidelines detailing the 
relevant processes would be also welcome. 
2.192.  The representative of Korea shared the concerns expressed by previous speakers. In 
particular, Korea emphasized the importance of acce pting test reports issued by the internationally 
accredited laboratories.  
2.193.  The representative of China said that the Regulations for the Supervision and 
Administration of Medical Devices divided medical devices into three categories according to the 
level of risk: Class I, II, III – from low to high risk. These were regulated differently: Class I medical devices only needed to be filed while Class II and III had to go through registration. On 
manufacture, Class I medical devices only need to be filed, while Class II and III needed to be 
examined and approved by CFDA. Regarding business operation, there were no special limits set by CFDA on Class I medical devices while Class II medical devices need to be filed, and Class III medical devices had to be licensed. The medical devices not listed in the catalogue could also 
apply for exception if relevant materials could be provided when registered to prove the security 
and effectiveness of the medical devices. CFDA had received many comments on market approval 
from the country of origin. It was stressed that the requirement was important to ensure the 
security and effectiveness of medical devices an d to protect the health of Chinese consumers. 
CFDA would continue to communicate with relevant enterprises and associations – both foreign and domestic – on these measures and would full y considered comments received from Members. 
2.2.3.21  Peru — Implementing Regulation s of 14 November 2012 for Moratorium on 
Planting Genetically Engineered Crops (IMS ID 392) 
2.194.  The representative of Mexico thanked Peru for the on-going bilateral dialogue on Law No. 
29811. While Mexico recognized the right of each  Member to regulate so as to protect the 
environment, there were concerns with some provisions of the Peruvian measure. On the access 
for conventional seed to Peru, the requirement for absolute zero presence of GM events in seeds 
was considered neither possible nor commercially practical and could therefore infringe on Article 
5.1.2 and 5.2 of the TBT Agreement. Absolute zero did not exist in the setting of thresholds for GM 
vegetable material as the biological product passed through various stages in production where all existing detection technologies had a margin for error which could product false positives and false G/TBT/M/68 
 
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  negatives. The most widely recognized quality stan dards for varietal identity and purity established 
by OECD and AOSCA28 r e c o g n i z e d  t h a t  t h e r e  w a s  s o m e  d e g r e e  o f  v a r i a b i l i t y  i n h e r e n t  i n  a n y  
biological reproduction system and achieving 100% varietal purity was practically impossible and economically unviable. Mexico believed that Peru could be in breach of Article 2.4 of the TBT 
Agreement as this provision did not appear to be  based on an international standard. Therefore, 
Mexico requested that Peru: (i) recognize the OECD and AOSCA purity standards and certification; (ii) consider recognizing non-GMO certification issued by third party laboratories that were certified 
by a recognized authority and accepted by the standa rds of the Peruvian authorities, at the port of 
loading, rather than subjecting shipments to border inspections; (iii) promote bilateral dialogue with regulatory bodies studying low GMO levels in batches of conventional seed, as well as the determination of thresholds and detection technologies; and (iv) take into consideration the 
position of seed industries in other countries when analyzing national regulatory measures. Finally, 
she said that Mexico was aware that the Ministry of Agriculture and Irrigation of Peru had instructed the National Agricultural Research Inst itute of Peru to draft a proposed amendment to 
the regulations implementing Law No. 29811, allowing GMO tolerance limits in imports of 
conventional seed. She asked for an update on how this was progressing. 
2.195.  The representative of Peru said that the la w establishing the moratorium on the planting of 
GMO crops in Peru was contained in an environmental regulation – it was not a specific technical 
regulation. Hence, Peru was not required to notify the measure to the WTO because it was not a technical regulation under the TBT Agreement. 
2.2.3.22  Ecuador – Proposed Motor Vehicl e Safety Regulatory Requirements  
(RTE INEN 034), G/TBT/N/ECU/32, G/TBT/N/ECU/32/Add.1-6 (IMS ID 409) 
2.196.  The representative of Mexico recalled that formal comments had been submitted to 
Ecuador on 12 November 2013 and concerns had been reiterated bilaterally, including at the vice-
ministerial level. Nevertheless, some concerns remained regarding Ecuadorian Standardization 
Institute Technical Regulation RTE INEN No. 034 on motor vehicle safety parts.29 The concern had 
first been raised at the Committee meeting of 5 and 6 November in 2014 and reiterated in March 
2015. Likewise, on 8 May 2015 Mexico had circulated the "Statement by Mexico to the 18-19 
March 2015 meeting of the Committee on Technical Barriers to Trade", circulated on 11 May as document G/TBT/W/410. Mexico's concerns relate to the following points. First, regarding the transition period for the entry into force of the Regulation, a period of 180 days (six months) had 
initially been established. Mexico requested that the deadline be extended in order to provide 
suppliers with sufficient time in which to comply with the measures imposed. Although the latest amendment provided for implementation by October 2016, thereby granting a transition period of 
one and a half years, Mexico believed that th e deadline needed to be extended until April 2017, 
which would provide a period of two years in which to offset the business losses of the Mexican automotive export industry. Second, Mexico had been informed that the provisions of Technical 
Regulation RTE INEN No. 034 (1R) might be changed in order to recognize foreign standards that 
could be considered equivalent to those of the United Nations Economic Commission for Europe (UNECE). While Mexico appreciated this, Mexico reiterated that it would like Suppliers Declaration of Conformity (SDoC) not to be excluded as one of the options for complying with this technical 
regulation. 
2.197.  Mexico thus requested Ecuador to extend to two years the transition period for 
implementation of the changes envisaged in the technical regulation, as from the date of its 
publication, and to provide information regarding the current state-of-play concerning acceptance 
of the results of the assessment of conformity as  regards compliance with foreign standards, and 
whether this would include acceptance of self-certification (SDoC) as a demonstration of 
producers' compliance with the technical regulation.  
2.198.  The representative of the United States supported the comments from Mexico. 
2.199.  The representative of Ecuador said that, as  had been indicated on previous occasions, the 
requirements established in Regulation No. 034 we re consistent with international standards (UN 
standards) developed through a system supported by the World Forum for Harmonization of 
                                               
28 Association of Official Seed Certifying Agencies. 
29  Notified in document G/TB T/N/ECU/32 and its most recent  amendment, circulated in 
G/TBT/N/ECU/32/Add.9 on 27 November 2015. G/TBT/M/68 
 
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  Vehicle Regulations (WP.29) which provided the gu arantees needed to regulate the safety of 
vehicles and to protect its citizens. The system ensured that vehicles were produced in such a way as to provide safety throughout the production l i f e  c y c l e  o f  e a c h  m o d e l .  W i t h  r e g a r d  t o  t h e  
transition periods established for the implementation of RTE INEN No. 34, the Ecuadorian 
authorities had once more extended the time frame for the entry into force of the Regulation, this 
time until October 2016. The declaration issued by  the manufacturer would be accepted during this 
period. Under NTE INEN No. 1155, daytime running lights (front and rear fog lights) were optional; 
however, where present, they had to comply with the provisions of this Ecuadorian Technical 
Standard. The conformity assessment procedure established in RTE INEN No. 034 (3R), which was based on standards equivalent to those of the United Nations Economic Commission for Europe (UNECE) referred to in this Regulation, was bein g examined by the competent national authority 
and the other Ecuadorian regulating entities concerned. 
2.2.3.23  Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial Council on 
the sale and marketing of energy dr inks of 4 March 2014, G/TBT/N/SAU/669, 
G/TBT/N/ARE/262, G/TBT/N/QAT/389, G/TBT/N/SAU/910, G/TBT/N/SAU/912 
(IMS ID 442) 
2.200.  The representative of Switzerland noted that his delegation had already voiced concern 
about the above-mentioned Decree (N°176) of 4 March 2014, notified in G/TBT/N/SAU/669. 
Comments had also been issued regarding the draft GSO standard on handling of energy drinks, notified under G/TBT/N/ARE/262, and recently under N° 910 and 912, on behalf of Saudi Arabia and of the Gulf Cooperation Council (GCC) members. These technical regulations required 
mandatory statements on the product for "energy drinks", as well as restrictions on marketing. 
The mandatory statement for "energy drinks" had hardly been modified since the last draft. The latest version, notified on 28 January 2016 required a mandatory statement aimed at people with 
high blood pressure, youth under 16 years of age, or athletes during sport, to the effect that these 
groups should not drink the beverages. The latest notification included a specific Saudi annex with stronger statements to be put on the products: "w arning"; "this product has no health benefits"; 
"drinking more than 2 cans per day may harm your health". These measures differed from Codex 
standards on claims and on nutrition, including the principle whereby declarations on products 
should not lead consumers to believe that th ere is exact quantitative knowledge of what 
individuals should eat in order to maintain health, but rather convey an understanding of the 
quantity of nutrients contained in the product. According to the most recent scientific studies 
reviewed by Switzerland, there were grounds to mention caffeine content, and to raise awareness to pregnant or breastfeeding women, and children. No rationale to warn other groups could be 
found. The representative of Switzerland also noted restrictions to sales to people under the age of 
16 and the prohibition of mixing these drinks with non-alcoholic beverages such as juices as examples of trade restrictive practices. It was unclear what health impact Saudi Arabia and GCC 
countries expected from these unique measures, ho w the public reacted to such warnings, and if 
alternatives had been considered. Switzerland shared the legislators' intents regarding public health and consumer information. However, the measures appeared to be more trade restrictive than necessary. While Switzerland appreciated the notification from GCC countries, and their 
openness to dialogue, answers were still needed to questions on the draft standard. Switzerland 
hoped that these would be clarified before entry into force and that the draft standard would be 
less costly to implement and more in line with international standards. 
2.201.  The representative of the United States noted that although the present concern was 
directed towards Saudi Arabia, it was a GCC-wide technical regulation so the US comments were 
directed towards all of the Members of the GCC.  While the United States supported efforts to 
promote public health through increased consumer information, the US remain concerned about 
the scientific and other technical evidence used to support this regulation. As had been stated in US comments submitted in August, the US requested further information regarding the rationale for, as well as any research or data supporting the regulation, including size and total acidity 
limits, and the need for multiple health warnings. It was noted that at the Committee's last 
meeting, it had been said that there were consultations underway – however, the United States still had not received a response to its concerns. Could the GCC members provide an update on 
the status of these consultations? In addition, the United States would also like to again formally 
request a response to the comments submitted earlier.  
2.202.  The United States was concerned that the GCC's approach, particularly with regard to the 
ban on advertising and sponsoring events, whic h went beyond the approach that many other G/TBT/M/68 
 
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  countries had adopted, might unnecessarily restrict trade without improving public health 
outcomes. Could the GCC provide a timeframe in which it planned to respond to concerns raised, and could they explain when they expect ed the rulemaking process to progress? 
2.203.  The representative of the European Unio n supported the points made by Switzerland and 
the US. In particular, the EU shared concerns regarding the large discretionary restrictions which, 
on the basis of the notified draft, could be impose d on the marketing of these products by regional 
or local authorities. Such an approach made it possible for lower level authorities to create barriers 
to trade and as such was a source of regulatory  uncertainty. The EU was also concerned about the 
lack of clear scientific substantiation of the stat ement to be included on energy drinks. The EU 
reiterated its proposal to Saudi Arabia to engage bilaterally in a dialogue. 
2.204.  The representative of the Kingdom of Saudi Arabia thanked delegations for their 
comments. As had been explained at the previous meeting, held in June 2015, Saudi Arabia had 
already explained the reason for the implementation of this measure.30 Regarding the draft 
regulation which had been notified on 28 January, the GSO TBT Committee was still receiving 
comments from Members and questions would be replied to in due time; about 20 days still 
remained to complete  the comment period. 
2.2.3.24  Brazil – Draft Technical Resolutio n nº 69, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Co mposition, in Portuguese, in the Label of 
Personal Hygiene Products, Cosmetics and Perfumes, G/TBT/N/BRA/608 (IMS ID 443) 
2.205.  The representative of Mexico said that by failing to consider the existence of a widely 
accepted international nomenclature for the ingredients of cosmetic products (INCI nomenclature), 
the proposed measure might not be in line with Ar ticle 2.4 of the TBT Agreement. Mexico was also 
concerned with the distinction that the draft made between products from the European Union and imports from Brazil's other trading partners (speci fically those of the Latin American region), in 
violation of the non-discrimination principle in Arti cle 2.1 of the TBT Agreement. It was also noted 
that, in view of the foregoing, on 19 January  2015 Mexico had submitted formal comments to 
Brazil about the non-reliance on the INCI nomenclature system. Mexico had also requested an 
explanation of – or justification for – the benefits  of translating the names of product ingredients 
into Portuguese, since these use a large number of raw materials with highly complex technical names. In response, Brazil had said that the matter was subject to domestic judicial proceedings. Mexico therefore requested Brazil to inform  Members of the state of progress of the 
aforementioned judicial proceedings and, if appr opriate, whether the comments made in regard to 
compliance with Article 2.1 and 2.4 of the TBT Agreement could be taken into consideration. 
2.206.  The representative of Brazil explained that the measure at issue was not yet in force and 
was still under a process of public consultation. The draft resolution was developed by Brazil's 
competent agency in this field - ANVISA - in order to comply with a judicial decision. This decision established the obligation for producers of cosmetics to display on the label the chemical 
composition in Portuguese. This judicial decision, which was based on Brazil's consumer rights law, 
had been appealed and its effects suspended until further decision of a higher court. He also 
explained that ANVISA had held consultations on the draft measure and that all comments received were still under technical analysis. Therefor e, the final draft may still be changed. He also 
said that the draft measure did not prevent the use of the INCI (the International Nomenclature of 
Cosmetic Ingredients). INCI would create an additional obligation to translate into Portuguese the chemical composition of cosmetics. Brazil believed  that the draft measure should only be applied 
after the resolution of this judicial process and that it would be consistent, both with Brazil's 
internal laws and regulations, as well as with the TBT Agreement. 
2.2.3.25  Ecuador - (PRTE INEN) No. 111: Ener gy efficiency. Clothe s dryers. Labelling, 
G/TBT/N/ECU/152, G/TBT/N/ECU/152/Add.1, G/TBT/N/ECU/87, 
G/TBT/N/ECU/87/Add.1-4 (IMS ID 455) 
2.207.  The representative of Mexico said that the Mexican industry continued to be concerned 
about the marketing of products of energy efficien cy classes "A" and "B". The industry maintained 
that while in principle, the technical regulation re cognized both classes, in practice only energy 
efficiency class "A" washer-dryers were permitted. Moreover, it had emerged from bilateral 
                                               
30 G/TBT/M/67, para 2.196. G/TBT/M/68 
 
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  communications with Ecuador that Technical Regulation RTE INEN No. 111 was currently being 
revised and studied in order to consider the equivalence of UL standards and IEC or European standards. She said that if the products were to be assessed as being in conformity with IEC, EN, 
or UL standards, the results of the analysis under way would be accepted. 
2.208.  Given the foregoing, Mexico requested Ecuador, with respect to Technical Regulation RTE 
INEN No. 111: (i) to provide an update on the revisi on of this measure, in terms of the recognition 
of foreign standards; (ii) to provide technical or scientific justification for the requirements of this 
measure concerning authorization for energy efficiency class "A" washer-dryers. On this particular 
point, Mexico expressed its view that Ecuador may be contravening the proportionality principle established in Article 2.2 of the TBT Agreement by  defining excessively high ranges of energy 
efficiency in relation to the legitimate objective pursued, which would unnecessarily limit the 
access of products to the Ecuadorian market; and (iii) to provide information regarding the risk 
that might arise from not achieving the measure's legitimate objective, by adopting the restriction laid down in Article 10.4 of the measure. 
2.209.  With regard to Ecuadorian Technical Regulation RTE INEN No. 072, "Energy efficiency of 
ductless air conditioners", she recalled that Mexico had asked Ecuador whether it based this measure on International Standard ISO 5151:2010 ("Non-ducted air conditioners and heat pumps 
- Testing and rating for performance") . Regulation No. 072 stipulated that tests must be carried 
out in conformity with Ecuadorian Technical Standard NTE INEN No. 2495, section 7 (Test Method). This Technical Standard provided for the application of the "test method established in Standard ISO 5151", which established the conditions specified under this standard that were 
most representative for the country. 
2.210.  Further, as to the specific concern related to the application of International Standard ISO 
5151 to types of air conditioner known as "inverter" air conditioners, she said that, according to 
conformity assessment experts in Mexico, these types of air conditioners were units equipped with 
a variable speed compressor, with a variable flow rate. She also said that testing has demonstrated that the method was not designed  for this type of technology. Additionally, 
follow-up testing has shown that it may not comply because of the actual functioning of the unit. 
In this regard, Mexico asked whether this type of product may be exempted from compliance with ISO 5151.  
2.211.  Finally, she expressed the Mexican indust ry's view that one of the ongoing problems 
concerning Ecuadorian technical regulations on household electrical goods was that amendments 
were applied almost immediately without allowi ng a reasonable period of time for their 
implementation. She thus asked Ecuador to take this comment into account when adopting or 
amending measures in the future. 
2.212.  The representative of Ecuador explained that since 2013, Ecuador had been developing a 
number of policies seeking to improve the quality of products marketed in the country. In this 
context, INEN ( Servicio Ecuatoriano de Normalización ), together with the regulatory body, the 
Ministry of Electricity and Renewable Energy  (MEER), had prepared Ecuadorian technical 
regulations on the marketing of energy-efficient pr oducts, whereby ranges had been established in 
accordance with product characteristics. Keeping in mind the legitimate objective of promoting 
energy efficiency, Ecuador had carried out an analysis and considered it appropriate for the 
country to adopt the criteria established in IEC international standards and European standards. The inclusion of UL standards was currently being reviewed, as reported to Mexico at the bilateral 
level. 
2.2.3.26  European Union – Common Criteria for Information Technology Security 
Evaluation (Common Criteria) Certif ication in the EU (IMS ID 448) 
2.213.  The representative of China reiterated her delegation's concerns with the refusal of the CC 
certification bodies of EU member States to accept and process the applications of Chinese 
producers for CC certification and the lack of opportunity for Chinese companies to join CC-related standard organisations, such as JIL Hardware A ttack Subgroup. She also repeated China's request 
for the EU to provide additional CC-related information to China and take a constructive approach 
to address the concerns of the Chinese industry. To date, the EU's sole response to these questions and concerns had been to claim that CC certification did not fall within the scope of the G/TBT/M/68 
 
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  TBT Agreement. In this respect, China believed that depending on the nature of CC certification 
bodies of EU member States, either Article 5 ("A ssessment of Conformity by Central Governmental 
Bodies" or Article 8 ("Assessment of Conformi ty by Non-governmental Bodies) of the TBT 
Agreement would apply. Further, in the case of a central governmental body, then both articles 
would apply. She noted that TBT obligations imposed on Members in this regard included: national 
treatment, avoidance of unnecessary obstacles to  international trade, prompt acceptance of 
applications, expeditious undertaking and comp letion of conformity assessment procedures, 
publication of the standard processing period of each conformity assessment procedures or 
communication of the anticipated processing period. Moreover, the EU had mentioned that EU companies received discriminatory treatment under China's regulatory framework. However, according to Chinese statistics, dozens of foreign companies had received production permits in 
China. For example, Giesecke & Devrient, from Ge rmany, received not only a production permit, 
but also sales permission for a cryptogram product.  
2.214.  The representative of the European Union said that, so far, China had failed to identify 
concrete specific measures (technical regulations or conformity assessment procedures) in this 
area which would fall within the scope of the TBT Agreement. Instead, China's claims had been made in a rather generic manner. He also explained that in the EU there were no general 
mandatory requirements for certification of commercial encryption products and that this was 
quite different from the situation observed in China.  He also expressed his delegation's belief that 
this was a very specialized field where there was a genuine need for exchanges at expert level. In the field of information and cyber security all interested parties faced similar challenges, where all 
systems were exposed to the same type of cybe rattacks. There was therefore a need for these 
systems to be able to use the best technology av ailable on the market in order to harness their 
protection and the protection of the data of info rmation exchanged. The EU therefore invited China 
to engage more in cooperation and discussions with its main trading partners in this field and 
avoid developing home-grown solutions which coul d prevent operators in China from procuring the 
best technology available on the market. 
2.2.3.27  China - Administrative Me asure on Cosmetics Labelling (AMCL), 
G/TBT/N/CHN/1064 (IMS ID 456) 
2.215.  The representative of Japan welcomed the clarification made by China in previous 
meetings that this measure would not entail "over-labelling" on imported cosmetic products. She 
said that, nonetheless, Japan was still concerned with Articles 14 and 15 of the draft measures, 
which required, inter alia, labelling of the names and addresses of manufacturing subcontractors. Japan considered that this requirement could cause consumer misunderstandings and market 
confusion. Instead, the manufacturer labelling sh ould only present the name and address of the 
company with final legal responsibility for the qual ity and safety of the products concerned. Japan 
was also concerned with the promotional advertising of cosmetics efficacy claims. According to 
Articles 19 and 20 of the draft measures, results from tests by an "efficacy assessment testing 
organization" had to be disclosed. However, she said, since testing results could include companies' know-how, they should not be disclosed. In addition, the "efficacy assessment testing organization" should not be limited to institutions inside China.  
2.216.  She also said that the measure needed to be accompanied by clear guidance. Japan asked 
China to provide an implementation plan, including a two-year transition period, for the smooth implementation of the new labelling regulation. Since the old implementation date (1 July 2015) 
had already passed, she asked China to explain what the new implementation date would be. She 
also asked China to clarify whether or not a public comment period would be established. It was recalled that at the last Committee meeting in November 2015, China had mentioned that this 
draft AMCL would be revised according to the contents of "Regulations concerning Hygiene 
Supervision over Cosmetics", which was a superior regulation to the draft measures. In this regard, Japan asked China whether it would revi se requirements for manufacturer labelling and 
efficacy assessment testing. 
2.217.  The representative of Canada noted the si gnificant time needed for industry to adapt and 
comply with the measures. He asked China to prov ide for longer timelines to manufacturers before 
the measures entered into force. Canada also asked whether manufacturers would be required to 
change their non-Chinese product names and sublines to comply with the Administrative Measures 
and be required to re-register their products in Ch ina. If this were the case, Canada further asked 
how much time companies would have to sell thro ugh products that were already placed on the G/TBT/M/68 
 
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  market in China. Canada was particularly concerned that such measures could negatively impact 
the cosmetics industry by forcing existing produc ts off the market and delaying exports of new 
products into China. Canada also asked China to confirm that product names that were registered as trademarks in English, or other foreign languages, would be subject to the Administrative 
Measures. Canada was concerned that if manufactur ers were required to create a different English 
name, or remove the English name from products sold in China, it would create significant confusion among Chinese consumers and opportunities for the production of counterfeit goods, 
causing severe disruptions on the market. 
2.218.  With respect to over-labelling, the representative of Canada said that, while China's 
willingness to allow over-labelling to apply Chinese language on product packaging was commendable, Canada would nonetheless need more  clarification regarding the widely accepted 
practice of "global packaging variant". Global pa ckaging variant allowed manufacturers to create 
one package featuring several regulatory warnings and claims complying with multiple markets. It also allowed manufacturers to only over-label a smaller portion of the packaging. Canada was 
therefore concerned that if over-labelling could not be utilized in this manner, it could affect a 
manufacturer's ability to sell in the Chinese market given the significant extra costs for supporting a China-only packaging variant for all products. 
2.219.  With respect to the December 2014 draft of the Administrative Measures, Canada was 
concerned that Chinese language was required on the primary and secondary packaging as well as on the leaflet. Canada was of the view that, given that consumers would be only able to view the outermost packaging at the point of sale, it should be acceptable to include the mandatory 
information (such as warnings and usage instructions) on the secondary leaflet in Chinese and not 
on the primary packaging. Otherwise, these requirements would place China at odds with international practices, and it would also create additional burden for industry to over-label the 
primary packaging. Canada was further concerned about the Administrative Measures' 
requirements according to which a formula must be sold in the country of origin before it could be sold in China. This requirement would make China the only major market in the world with such a 
requirement. Canada believed that this would fundamentally interfere with the launch of innovative 
new products in the Chinese market. Finally, Canada asked China to confirm whether, and when, a new draft of the Cosmetics Supervision and Admi nistration Regulation would be released.  
2.220.  The representative of the European Union welcomed the possibility of labelling cosmetic 
products by means of stickers. His delegation was, however, still concerned with the following 
issues included in the notified draft, namely: (i ) the requirement for the products to display the 
name and address of the manufacturer and of the su bcontractors when part of the production was 
done by subcontractors; (ii) the need to confir m that the efficacy assessment and the cosmetic 
claim verification could be conducted by any verifying organization that was scientifically and technically competent to do so according to the criteria and guidance established by the China 
Food and Drug Administration (CFDA) – on the latter, the EU believed that any requirement for 
third party verification by a Chinese organization would be more trade restrictive than necessary; and (iii) the need to align the requirements regarding cosmetic claim substantiation with international best practices. 
2.221.  The EU understood that the process for the revision of the general legal framework for the 
placing on the market of cosmetics in Chin a (i.e. the future Cosmetics Supervision and 
Administration Regulation) was still ongoing. He therefore asked China to confirm that the AMCL 
would be developed in parallel with this general framework and would not enter into force before 
the Regulation. He also asked China for information on the implementation of the guidelines on the verification of efficiency of claims related to cosmetic products presented by CFDA at the technical 
meeting with their EU counterparts in March 2015.  
2.222.  The representative of Australia asked China to clarify its current transparency practice to 
ensure Australian businesses had full information about the regulatory measures. In this respect, 
he asked China to confirm: (i) that animal testing for the safety of cosmetic products was not 
required when widely accepted alternatives were available; and (ii) whether all cosmetic 
manufacturers were treated equally with respect to product registration and approval. 
2.223.  The representative of China said that, in most markets, cosmetic labels in particular were 
essential for consumers to understand basic information on these products. Currently, AMCL was G/TBT/M/68 
 
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  still under drafting. She stated that CFDA would follow international rules and give full 
consideration to valuable inputs from interested parties before finalizing this measure. 
2.2.3.28  China - Banking IT Equipment Security Regulation (IMS ID 457) 2.224.  The representative of Japan asked China to provide updated information about the revision 
of the "Guideline for Promoting the Application of  Secure and Controllable Information Technology 
in Banking Sector (2014-2015)", issued in December 2014. He said that his delegation still had concerns that some points of the measure would be more trade restrictive than necessary, such as 
requiring source code submission without clarifyi ng the range of data scope. Therefore, Japan 
requested China to revise the Guideline in accordance with international standards, ensuring transparency during the review process. In  addition, he noted that Fact Sheet of 26
th Session of 
the US-China Joint Commission on Commerce and Trade, held in November 2015, stated that 
China would revise these Guidelines, and Japan as ked for further information in this respect.  
2.225.  The representative of Canada welcomed  the opportunity to discuss China's proposed 
national security regime and the related bankin g security guidelines. While Canada understood 
China's desire to minimize threats to its ICT infrastructure, he was of the view that China's 
approach to "secure and controllable" ICT would decrease – instead of increase – cyber security for China's network and banking ICT infrastructure. Canada agreed with the concerns raised by other 
Members and emphasized that the drafting of the measure at issue was more trade restrictive 
than necessary to achieve China's national security objectives. In Canada's view, China's insistence on requirements to divulge and revi ew source code, local content requirements for 
hardware, software and intellectual property, and mandatory adoption of Chinese encryption 
processes would not be consistent with China's national treatment obligations under Articles 2 and 
5 of the TBT Agreement. Canada understood that China had suspended the implementation of its 
banking security guidelines as of June 2015, and asked China to elaborate on whether the 
suspension was definitive or whether there was a timeline for revision.  
2.226.  The representative of the European Union supported the statements of other Members, 
and asked for an update on the ongoing review of  the banking guidelines. He requested China to 
address the concerns voiced by Members and industry, and to ensure that this process would be 
transparent and inclusive. He said that further revisions to the guidelines should be notified to the TBT Committee in order to provide Members an d their interested parties with adequate 
opportunities to comment. 
2.227.  The representative of the United States supported the interventions made by the other 
delegations on this issue. 
2.228.  The representative of Australia said that his delegation continued to monitor progress on 
this issue as Australian industry and businesses were interested in any potential regulations that 
could impact their ability to operate in the Chines e market. As noted at the last meeting, Australia 
was aware that the regulations had been suspen ded and requested further information on their 
status, including any TBT notification of the regulations.  
2.229.  The representative of China said that the "Guideline for Promoting the Application of 
Secure and Controllable Information Technology in Banking Sector (2014-2015)" was currently 
under revision and that China would take commen ts from stakeholders into consideration. She 
informed the Committee that there was currently no timeline for the release of a finalized version. 
2.2.3.29  Indonesia - Regulation of the Mini ster of Agriculture No. 139/Permentan/PD.4, 
10 December 2014, concerning Importation of  Carcass, Meat and/or Processed Meat 
Products into the Territory of the Republic of Indonesia, and Regulation of the Minister 
of Agriculture No. 02/Permentan/PD.4, 10 January 2015, concerning the Amendment of 
the Regulation of the Minister for Agri culture No. 139/Permentan/PD.4, 10 December 
2014, G/TBT/N/IND/98, G/TBT/N/IND/98/Add.1 (IMS ID 461) 
2.230.  The representative of Canada said that his delegation remained concerned with Indonesia's 
measures notified under G/TBT/N/IDN/98, and was currently assessing the amendments notified 
on 11 January 2016 under the draft Regulati on of the Minister of Agriculture No. 
58/Permentan/PK.210/11/2015 concerning Importation of Carcass, Meat and/or Processed Meat G/TBT/M/68 
 
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  Products Into the Territory of the Republic of Indonesia. Canada remained concerned with the 
broad product coverage of the regulations and the lack of clarity about their intended objectives. 
Canada added that the proposed measures could be unduly trade restrictive and inconsistent with national treatment obligations of the TBT Agreement and the GATT. He urged Indonesia to provide 
more clarity regarding the proposed measures, specifically with regard to how these measures fell 
within the scope of the TBT Agreement and how they  would be consistent with Indonesia's national 
treatment obligations. 
2.231.  The representative of Australia expressed continued concern with Indonesia's regulations 
on the importation of meat and meat products. Sh e noted that Indonesia had replaced Minister of 
Agriculture Regulations Number 139/2014 and Number 2/2015 with Minister of Agriculture Regulation Number 58/2015, which entered into force on 7 December 2015. She said that 
Indonesia's notification of this amendment in Addendum G/TBT/N/IDN/98/Add.1 was not issued 
until 11 January 2016, after the new regulation entered into force. Furthermore, the new regulation did not address the concerns previously raised by Australia and other WTO members, 
and retained trade-restrictive provisions which were inconsistent with Indonesia's WTO obligations. 
She stressed that the new regulation imposed additional restrictions on imports of meat and meat products, including new restrictions on how long meat products can be st ored before arrival to 
Indonesia. Australia was particularly concerned that the new regulation continued to only allow 
State Owned Enterprises (SOEs) and Regional State Enterprises to import secondary beef cuts and carcasses, and only then in limited defined circumstances at the direction of Government Ministers, in volumes determined by Ministers in a 'coordination meeting'. The new regulation maintained 
additional packing, labelling and purpose-of-use re quirements on imported meat products that did 
not apply to domestic products and continued to prohibit the importation of a range of meat products and cuts, including certain types of offal. Australian offal was produced for human 
consumption and was regulated under the same food health standards and legislation as meat for 
human consumption. Australian beef and offal had a reputation for quality, safety and reliability. Finally, Australia asked to Indonesia for further information on how its new regulation was 
consistent with its WTO obligations and offered further constructive bilateral discussions on this 
issue. 
2.232.  The representative of the European Union supported concerns of other Members with the 
Regulation of the Minister of Agriculture No. 139/Permentan/PD.4, of 10 December 2014 on 
Importation of Carcasses, Meat and/or Its Processe d Products Into the Territory of the Republic of 
Indonesia, as amended. He reported that on 1 February 2016, the EU provided written comments to Indonesia on the latest amendment to this Regulation, which was notified after the measure 
entered into force. He asked for a written reply to these concerns, in particular on the 
requirements for production premises and transportation of Halal products, which should be aligned with relevant standards. 
2.233.  The representative of Brazil endorsed the Australian and Canadian concerns about the 
restrictive measures enacted by Indonesia on the importation of bovine meat and related products. 
His delegation noted three specific concerns with  the Minister of Agriculture Regulations Number 
139/2014, namely: (i) the measure established the purchase of a certain amount of domestic beef 
as a condition for the importation of bovine meat; (ii) the importation of beef would only be 
allowed in some specific and limited end-uses, such as for hotels, restaurants, catering and special needs, among others; and, (iii) one of the licensi ng requirements for importation was subject to 
short time periods and strict deadlines.  
2.234.  Although Minister of Agriculture Regula tion Number 139/2014 was recently replaced by 
Minister of Agriculture Regulation Number 58/2015 as mentioned in previous interventions, 
Indonesia continued to impose prohibitions and restrictions on international trade in violation of its 
commitments under the WTO agreements. Brazil ther efore invited Indonesia to bring its measures 
into conformity with its WTO obligations; however, if this situation persisted, Brazil would be ready to exercise its rights before the WTO Dispute Settlement system. 
2.235.  The representative of Indonesia replied to the concerns raised. Indonesia's full statement 
is contained in document G/TBT/W/444. G/TBT/M/68 
 
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  2.2.3.30  Ecuador - Emergency Technical Re gulation (RTE) No. 088: "Surface tension 
agents" of the Ecuadorian Standardizat ion Institute (INEN), G/TBT/N/ECU/117, 
G/TBT/N/ECU/117/Add.1-2, G/TBT/N/ECU/ 106, G/TBT/N/ECU/106/Add.1-3 (IMS ID 
458) 
2.236.  The representative of Mexico reiterated her delegation's concern with respect to this 
measure, originally notified to WTO Members as an Emergency Technical Regulation on 
22 November 2013, in document G/TBT/N/ECU/117 and its addenda. This concern had first been 
raised at the March 2015 Committee meeting and reiterated at the June 2015 meeting, and 
Mexico's statements at those meetings had been circulated to Members.31 
2.237.  She reported that the bilateral exchange between the two countries had clarified Mexico's 
doubts concerning the amendments made to this technical regulation. Mexico asked Ecuador to 
explain the mechanism under which the Ecuadorian Accreditation Service (SAE) would accredit 
first-party certificates as stipulated in Article 10.2.4, which provided: "the first-party conformity certificate shall be accepted until such time as there are product certification bodies and 
laboratories, accredited or designated in the country of destination, or accredited in the country of 
origin, whose accreditation is recognized by the SAE". Finally, she observed that this measure had been notified to Members in various document symbols on different dates. Mexico reiterated the 
importance of ensuring that notifications concerni ng the same measure preferably be submitted as 
addenda to the original notification, facilitating the notification follow-up process. 
2.238.  The representative of Ecuador said that the Amendments Nos. 1 and 2 to RTE INEN 
No. 088: "Surface tension agents" were published in Official Journal (Registro Oficial) No. 655 of 
23 December 2015, and the Supplement to Official Journal No. 660 of 31 December 2015, 
respectively. These amendments modified certain provisions relevant to the application of this Regulation. The Regulation was based on the Andean Community (CAN) Decision No. 706 of 
10 December 2008 on the harmonization of legislation on domestic hygiene products and 
absorbent personal hygiene products. Finally, she informed the Committee that the Ecuadorian Ministry of Foreign Trade had formally responded to the trade concerns submitted on various 
occasions by the Mexican delegation in Official Communication No. MCE-VNIDC-2016-0060-0 of 
27 January 2016, and in bilateral meetings. 
2.2.3.31  European Union - Proposed modi fication of Regulation (EC)1829/2003 
referring to genetically modified organisms, G/TBT/N/EU/284 (IMS ID 464) 
2.239.  The representative of Canada reiterated his delegation's concerns on this proposal, 
including those expressed at the last two TBT an d SPS meetings held in the latter part of 2015.32 
Canada thanked the EU for the August 2015 repl y to their comments on this notification. He 
restated Canada's questions about the consistency of this proposal with the WTO commitments 
and internal market rules of the EU. He referred to the recent opinion of the European Council's Legal Service which echoed Canada's view. His de legation was still concerned that EU member 
State measures taken under this proposal could cause serious trade disruptions and uncertainty 
for the EU's international trading partners with respect to food and feed imports to the EU. He asked for an update on the progress of this proposal and whether the EU intended to present an alternative proposal. He said that Canada would continue to closely monitor the proposal as well as 
its potential impacts on trade. 
2.240.  The representative of Argentina shared the concern expressed by Canada with the 
proposal enacted by the EU and reiterated his particular concerns on account of its inconsistencies 
with the EU's WTO commitments and the EU's own regulations. Argentina reiterated that EU 
member States already had the option of adopting emergency measures to prohibit or restrict the marketing and imports of biotechnological products based on scientific evidence of serious risk to 
human, animal health or the environment. Argentin a found it difficult to comprehend the objective 
of the notified proposal by the EU and requeste d the withdrawal of the current proposal, and the 
implementation, in a timely and proper manner, of current EU legislation on the approval and 
authorization of GMOs throughout EU territory. He argued that the measure in its present form 
would create a high level of unpredictability in international commodity markets and would 
unjustifiably impact producers in the EU and thir d countries. Further, he asked the EU delegation 
                                               
31 G/TBT/W/405 and G/TBT/W/439. 
32 G/TBT/M/67, para. 2.220 and G/TBT/M/66, para. 3.10. G/TBT/M/68 
 
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  to advise about the next steps to be taken in respect of this dossier, in particular: whether the 
EC's legal services had finished preparing their opinion; whether amendments to the proposal were under discussion; or whether the Commission was considering putting forward a new proposal or withdrawing the proposal altogether, as had been requested by third countries and EU institutions. 
Finally, Argentina insisted that the EU should no tify any proposal to the WTO SPS Committee, the 
appropriate forum for discussing  measures of this nature. 
2.241.  The representative of the European Union provided an update on the proposal for a 
Regulation of the European Parliament and of the Council amending Regulation (EC) No 1829/2003 
as regards the possibility for member States to restrict or prohibit the use of genetically modified food and feed on their territory. He stated that, on 28 October 2015, the Commission proposal had been rejected in the European Parliament through the adoption of a Legislative Resolution, which 
called on the Commission to withdraw the proposal and propose a new one. Nevertheless, the 
Commission had informed the European Parliament that it maintained the existing legislative proposal. Discussions at the Council of Ministers, which was co-legislator together with the 
European Parliament, were still on-going and the legislative process would continue. Finally, he 
noted that the Commission would continue enforcing the existing legislation on GMO food and feed, and informed the Committee that the EU had replied to comments received on notification 
G/TBT/N/EU/284. 
2.2.3.32  Indonesia - MOI 69/2014 Article 3:  LCR Requirements for LTE Devices - 
Requirement that Domestic Component Le vel (TKDN) of LTE TDD & FDD broadband 
services equipment, G/TBT/N/IDN/103 (IMS ID 472) 
2.242.  The representative of Canada expressed concerns with respect to Indonesia's intention to 
introduce local content requirements for smartphones using 4G/LTE technology, which were in 
addition to other Indonesian local content requ irements, whereby telecom service providers and 
telecommunication operators were forced to allocate 50% of capital expenditures to local 
companies. He sought clarification on whether these new local content requirements had been notified to the WTO and whether Indonesia planned to take Members' concerns into account when 
finalizing these draft regulations, as per their ob ligation under Article 2.9.2 of the TBT Agreement. 
By providing treatment that was less favourable to foreign firms than that accorded to like products of national origin, Indonesia's approach was at odds with the provisions of Article 2.1 of the TBT Agreement. He requested that Indonesi a provide a justification for the approach and 
indicate the legitimate objective pursued. He also asked whether Indonesia had considered less 
trade-restrictive means given the objective of the regulation and what the consequences would be for a foreign company if it were to sell 4G-enabled equipment that did not meet the local content 
threshold in Indonesia. Finally, he asked when KOMINFO was planning to finalize the regulation. 
He also noted that there were many competent telecoms test labs worldwide and associated itself with previous comments of the EU and US in recommending that Indonesia accept test results 
from duly accredited labs regardless of their location.
33 He sought clarification as to whether local 
testing of software might count towards the local content requirements and welcomed any additional information from Indonesia that could provide clarification on the nature of the draft 
regulation. 
2.243.  The representative of the United States jo ined Canada in continuing to express concerns 
about the regulation that contained both technical requirements and conformity assessment 
procedures. First, these significant measures had not been notified to the TBT Committee prior to 
adoption, limiting the opportunity for other Memb ers to provide meaningful and useful comments, 
nor had Indonesia explained what circumstances ha d prevented notification. While recognizing and 
appreciating Indonesia's notification of KOMI NFO Regulation 27/2015 in February 2016 for public 
comment, she wondered how comments received wo uld be taken into account given that the 
regulation had already been published and entered into force. Second, she was concerned that the requirements, including the testing and conformity assessment procedures had gone into effect without providing for a reasonable interval between adoption and entry into force to allow 
companies time to adjust to the new requirements. In sum, she noted her delegation's 
disappointment that Indonesia had proceeded with th is regulation despite concerns received from 
several Members. 
                                               
33 G/TBT/M/67, paras. 2.230 and 2.232. G/TBT/M/68 
 
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  2.244.  The representative of Australia said that his delegation was monitoring the status and 
implementation of the regulation, thanked Indonesi a for notifying the WTO of previous regulations, 
such as No.5/2013 and No.18/2015, and invited Indo nesia to notify all current regulations for LTE 
devices to ensure that Members' concerns could be considered during the proposal and 
implementation phases. He sought information on  the expected impact that the requirement for 
local testing and certification was likely to have on the compliance of LTE equipment. Further, he sought clarification on Indonesia's previous statement: "in principle, Indonesia accepted the test 
results issued by foreign test institutions, which were accredited internationally" as it was unclear 
what "in principle" meant in practice. 
2.245.  The representative of Indonesia said that Indonesia had notified the Ministry of 
Communication and Information Technology Regulation No.27 of 2015 concerning Technical 
Requirements for Long Term Evolution Technolo gy (4G LTE) based Telecommunication Devices 
under G/TBT/N/IDN/103. With respect to concerns regarding local content calculation, he suggested that the concerned Members submit thei r enquiries to the Indonesia TBT Enquiry Point 
as the two-month comment period was open until April 2016.  
2.2.3.33  Chinese Taipei - GMO Labelling, G/TBT/N/TPKM/168, 
G/TBT/N/TPKM/168/Add.1, G/TBT/N/TPKM/168/Rev.1 (IMS ID 467) 
2.246.  The representative of Canada said that while recognizing and supporting Chinese Taipei's 
right to implement regulations that provided consumers with adequate information to make 
informed choices in the marketplace, Canada believ ed that this objective could be best achieved 
through voluntary, industry-led market-driven init iatives, as these were less trade restrictive. 
Voluntary standards could also help ensure that labelling claims were truthful and not misleading. 
Mandatory labels should only be used to convey important information about the health and safety of a product, where there were health risks such as allergens, or significant nutritional changes 
that could be mitigated through labelling. Products of biotechnology that had been assessed as 
safe and had been authorized for sale did not pose any risk to human health and safety, and 
therefore should not require labelling. He reiterated Canada's concern that, in the absence of 
identified safety risks, mandatory GMO labelling could be misleading to consumers, as it implied 
that there might be "issues" with the product, where in fact there were none. Implementing disproportionally trade-restrictive measures could be counterproductive to Chinese Taipei's efforts to modernize its food regulations. Canada continued to be concerned with what seemed to be a 
developing trend, whereby TFDA pre-empted potential political or public reactions through trade-
restrictive regulations. 
2.247.  The representative of the United States said that her delegation continued to question the 
science- and risk-based justification for Chinese Taipei to increase the stringency of its genetically 
engineered (GE) labelling requirements. Such labels implied an inherent difference for GE foods in relation to conventional food products where no such difference existed and were often taken by 
the consumer to imply a greater safety/health hazard. Although mandatory labelling might be 
proposed to ensure "consumer choice", economies with overly restrictive mandatory GE labelling requirements actually experienced reduced consumer choice as companies usually sourced non-biotech ingredients rather than using a label. She noted the US comments on the measure dated 
16 April 2015 and 27 July 2015 as well as concerns ex pressed in letters to the Ministry of Health 
and Welfare from the Office of the United Stat es Trade Representative in March 2015 and the US 
Department of Agriculture in May 2015. In particular , as the presence of authorized GE ingredients 
in food products did not pose a greater human heal th risk in comparison with conventional foods 
on a categorical basis, there was no scientific basis for these amendments and they might raise 
unjustified food safety concerns among the public. Overall, more restrictive mandatory labelling 
requirements would have a negative impact on  Chinese Taipei's domestic food processing 
industries, increase administrative burden as well as potential for corruption, and limit consumer choice, while not improving food safety. In additi on, these requirements could significantly disrupt 
US agricultural exports to Chinese Taipei, especially as enforcement and traceability requirements 
were unclear. Overall, there was likely to be an additional burden on food producers, exporters, 
and importers, increased costs to consumers and pressure for affected companies to exit the Chinese Taipei market. 
2.248.  Furthermore, she asked how the labelling requirements would be applied and enforced, 
including with respect to refined products that did not contain genetically engineered protein or DNA. Additionally, she asked what the intent was of the proposed traceability system for GE and G/TBT/M/68 
 
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  other agricultural products, as notified on 17 August 2015 under G/TBT/N/TPKM/207/Add.1, and 
how it would work. She also requested that Chinese Taipei notify details to the WTO so that Members could have an opportunity to review an d provide comments. Given that the enforcement 
and traceability requirements were unclear, the new regulations could not be implemented on a 
fair and transparent basis. Therefore, the US requ ested that Chinese Taipei revise its decision to 
implement regulatory changes on biotech label ling and continue with previous GE labelling 
requirements of a 5.0% threshold for labelling of food, where introduced protein and DNA may be 
present, since they had sufficiently addressed consumer choice for many years. 
2.249.  The representative of Australia thanked Chinese Taipei for responding to their comments 
on the proposed draft labelling requirements for food containing Genetically Modified Organisms. 
While recognizing Chinese Taipei's right to implement measures to provide consumers with 
information to make informed food choices, Australia asked Chinese Taipei to reconsider the 
proposed requirement to label food products with no altered characteristics and no discernible GM 
material since there was no scientific methodology to test highly refined food products derived 
from GM ingredients and since complying with the proposed changes would be costly for 
producers. She also requested an update from Chinese Taipei on the timeframe for implementation. 
2.250.  The representative of New Zealand welcomed Chinese Taipei's engagement both bilaterally 
and in the Committee on the regulations on pre- packaged food, food additives and unpackaged 
food containing ingredients of GMOs. New Zealand considered that the labelling requirements promulgated through the regulations could be confusing to consumers, resulting in unjustified 
concerns. When applied to food that was highly refined, where processing removed all transgenic 
DNA and transgenic proteins, the labelling requirements could raise unnecessary consumer concern and potentially desensitize them to labelling regarding GMOs. Consumers might not 
readily appreciate the difference between food derived from GMOs that no longer contained 
transgenic DNA or transgenic protein and food that did not contain transgenic DNA or transgenic protein. Food or food ingredients containing GMOs that were highly refined or where the 
processing removed all transgenic DNA or transgenic proteins had the same composition and 
characteristics as non-GMO food. There was no food safety concern for the consumer. Therefore, New Zealand encouraged consideration of an exemption in the regulation for foods and/or ingredients produced using GMO, where the final product did not contain transgenic DNA and 
and/or transgenic proteins and for highly refined ingredients. 
2.251.  The full response of the representative of Chinese Taipei is contained in G/TBT/W/466. 
2.2.3.34  China - Registration Fees for Drug s and Medical Device Products (IMS ID 466) 
2.252.  The representative of Canada thanked China's initial response provided at the November 
2015 TBT Committee meeting regarding registration fees for drugs and medical device products. 
Since then, Canada understood that China had made a number of commitments on certain aspects 
of the regulation. Canada welcomed these new developments but remained concerned about other 
important aspects of the regulation and on the ge neral lack of clarity and transparency regarding 
the measure. In particular, Canada continued to have concerns regarding China's new Medical Device Registration Fee Schedule published on 27 May 2015, which had entered into force without 
any notification to the WTO, failing to give Members a "reasonable interval between the publication 
of requirements concerning conformity assessment procedures and their entry into force", as per Members' obligation under the TBT Agreement. As  already mentioned at the previous Committee 
meeting, Canada was concerned with China's approach of combining registration fees with on-site 
inspection fees for foreign manufacturers and with respect to the lack of transparency regarding the registration fees for domestic products, which we re to be levied by China's provinces. In order 
to enhance transparency, Canada asked that China publish the on-site inspection fees separately 
from the registration fees for foreign manufacturers as well as the registration fees to be levied by China's provinces on domestic manufacturers so that it was clear what manufacturers were being charged and for which services, with a view to ensuring that the registration fees were in 
conformity with China's WTO national treatment ob ligations and that the on-site inspection fees 
corresponded to international averages. 
2.253.  With regards to the accelerated service being offered by the CFDA to fast-track 
applications for drugs and medical devices, Canada understood that foreign drugs and medical 
devices considered "innovative" could be eligible for fast-track evaluation and that China had also G/TBT/M/68 
 
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  made efforts to accept more submissions. Canada welcomed China's initiative to expand the scope 
of the fast-track programme and for providing guidelines on what constitutes an "innovative product." Nevertheless, Canada asked China to  confirm this commitment and clarify whether 
domestic and foreign firms would be charged the same fast-track fee, in line with national 
treatment provisions.  Finally, Canada had recently taken note of China's WTO notification 
G/TBT/N/CHN/1169, issued on 26 February 2016, regarding new registration categories of chemical drugs and sought additional information concerning the changes, in particular regarding 
the rationale for the changes to the drug registration categories. Regarding registration categories 
1 to 5 for chemical drugs, Canada asked whether China was going to charge different registration fees for these categories and whether this would result in drug registration fees that differed from those announced on 27 May 2016. With respect to the description of the categories, Canada also 
asked how China would define "innovative drugs" and "new improved drugs", whether "imitation of 
drugs" meant generic drugs and what the differenc e was between Category 3 (Imitation of drugs 
that are marketed overseas but unavailable domestically) and Category 5 (Application for the 
domestic marketing authorisation of drugs marketed overseas). 
2.254.  The representative of Australia said that businesses and industry organizations had raised 
concerns with the Australian Government regard ing the introduction of the new fee schedule and 
resulting processes. Australia thanked China for its response to their query through the TBT 
Enquiry Point; however, it continued to have concerns with the measure. The fee structure and the registration process was a technical regulation, which might not be based on international best 
practice and as such Australia asked that China notify the measure to the TBT Committee in 
accordance with Article 2.9 of the TBT Agreement.  Australia also wished to understand how China's 
notification G/TBT/N/CHN/1169, circulated on 26 February 2016, regarding changes to its Work 
Programme for the Reform of Chemical Drugs Regist ration Category, related to this specific trade 
concern and whether the notification changed any of the registration and fees for drugs and 
medical devices. Australia was concerned that  the implemented fee structure and process 
requirements provided for different fees for domestic and imported drug and medical device 
products and asked China to outline how the fee structure and process requirements for imported 
products were proportionate to the testing process requirements, including for the costs of transportation, accommodation and allowances. He asked whether domestically produced drugs and medical devices were subject to the same testing process and registration requirements, 
t h o u g h  a t  d i f f e r e n t  f e e s .  S o m e  o f  t h e  d o m e s t i c  p r i c e s  w e r e  b a s e d  o n  w h a t  w a s  t e r m e d  a  
"provincial price". He asked China to confirm what the provincial price was, how it was determined and whether the same testing processes and requ irements applied for the provincial price. 
Australia understood that the regulations allowed for small and micro business with an innovative 
medical device to have their registration fees waived for the first time registration and asked for additional information on how innovative products were defined, what the criteria were and 
whether domestic as well as imported products could be considered as innovative. Australia 
acknowledged that on-site inspections were necess ary to promote public health and ensure that 
products were safe and effective and also that inspections at foreign facilities might be more expensive. However, fees associated with foreign inspections needed to be transparent and non-
discriminatory and include industry consultation prior to implementation. 
2.255.  The representative of Korea drew attention to the unreasonably high level of fees for 
foreign companies, even if it took into account the on-site inspection costs. Therefore, Korea asked 
China for more transparency on how fees were dete rmined and calculated with a view to securing 
fairness in the level of fees for foreign companies. 
2.256.  The representative of China said that China had issued a new measure on registration fees 
for drugs and medical device products in May 2015. Prior to this new measure, the rule of 
registration fees for drugs and medical device products, set in 1995, had not included charges for the registration of medical device products. A standard dating back 20 years was not suitable for today's market. Even with the new standard, the registration fee charged in China was still far 
lower than the international level. Many Members were concerned that domestic and foreign drug 
and medical device registration charges differed; however, the gap only reflected costs related to foreign on-site inspection, transportation, accommo dation, meals and public charges. Article 5.2.5 
of the TBT Agreement required Members to ensu re that any fees imposed for assessing the 
conformity of products origination in the territories of other Members were equitable in relation to any fees chargeable for assessing the conformity of like products of national origin or originating in 
any other country, taking into account communication, transportation and other costs arising from 
differences between location of facilities of the applicant and the conformity assessment body. G/TBT/M/68 
 
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  Furthermore, differences in domestic and foreign fees were international common practice for 
partial product inspections. For example, in the United States, according to FDA prescription drug production facility inspection fees, foreign companies paid US$15,000 more than domestic companies. Regarding transparency, according to  Article 5.6 of the TBT Agreement, Members 
needed to notify to WTO "whenever a relevant gu ide or recommendation issued by an international 
standardizing body does not exist or the techni cal content of a proposed conformity assessment 
procedure is not in accordance with relevant guides and recommendations issued by international 
standardizing bodies." However, in this case, the fee system did not belong to the "technical 
content" of a conformity assessment procedure and therefore China had no obligation to notify it. 
In fact, China had not found any notifications to the WTO by other Members of similar fee structures. 
2.2.3.35  Colombia - Draft Ministry of Commerce, Industry and Tourism Decree 
"Restructuring the National Quality Subs ystem and amending Decree No. 2269 of 1993", 
G/TBT/N/COL/201 (IMS ID 432) 
2.257.  The representative of Canada said his delegation appreciated Colombia's initiative to 
ensure that Colombian consumers have access to safe products with high quality standards. 
Nevertheless, Canada sought clarifications from Co lombia on the intention behind the restructuring 
of Decree No. 2269 of 1993. Canada was concerned that the regulation, as modified by Decree 
1595, might create unnecessary barriers to trade and affect exports to Colombia. The requirement to obtain local conformity assessment for "medium- and high-risk" products, unless there was a mutual recognition of Colombia's certifications, could potentially discriminate against products 
exported to Colombia as well as constitute unnecessary barriers to trade. In particular, Canada 
was concerned that having to recertify products in Colombia could delay exports to the country - even if Colombia was not obliged to accept certificates from recognized accreditation organizations 
such as the ILAC or the IAF. With respect to the parameters for defining risk, not defining the risk 
level of products and allowing regulators themselves to determine risk levels could make requirements for exports unpredictable. He asked whether Colombia was planning to define what 
was considered medium and high risk. 
2.258.  Furthermore, Canada sought clarification on how the restructuring of the National Quality 
Subsystem and the new local certification requirement would affect products exported to Colombia. It was their understanding that technica l regulations were updated every five years and 
that local certifications would be required for new technical regulations. In its formal response 
following the November 2015 TBT Committee, Colombia had stated that "Decree No. 1595 of 2015 does not modify technical regulations that were already in effect before its entry into force…" 
Therefore, he asked whether updates to technical re gulations that were alread y in effect before the 
entry into force of Decree 1595 would incorporate local certifications. It had been brought to Canada's attention that some sectors might have favoured EU-based standards and certification 
bodies over others. Canada was concerned that most-favoured-nation and national treatment 
provisions might not be respected for all products imported into Colombia and sought clarification on the treatment of internationally-recognized standards and bodies. Finally, Canada was also concerned that amendments to Decree 1471 had not been notified to the WTO.  
2.259.  The representative of Colombia said that, in an effort to save time and be efficient, he 
would refer to some sections of Colombia's extensive statement circulated as G/TBT/W/438 in 
November 2015. Decree No. 1595 of 5 August 2015 had been drafted in an effort to update rules 
pertaining to the Colombian quality system and sought not only to organize and clearly define the 
functions of the various actors concerned, but to implement best practices for technical regulations. In this context, Colombia was in line with the recommendations heard during the 
thematic session held that week. Decree No. 159 5 had been notified to the TBT Committee under 
Article 15.2 of the TBT Agreement as G/TBT/2/Add. 18/Rev.1/Suppl.2 and was indeed an update of 
Decree 1471 notified as G/TBT/N/COL/201 on 7 Feb 2014, on which comments had been received through an exercise of voluntary transparency. It was fundamental for Colombia to undertake this 
update because it implemented best practices for regulations and standards, complied through 
various sources, including through the TBT Committee. Decree 1595 would have large-scale effects in guaranteeing free trade policies of Colombia. Colombia was interested in maintaining an 
open channel of communication and explaining in greater depth the implications of the Decree for 
both parties. G/TBT/M/68 
 
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  2.2.3.36  Turkey - Toy Communiqué 01/2015 (IMS ID 473) 
2.260.  The representatives of the United States and Canada thanked Turkey for their information 
that that verifications of toy imports at the border would cease in 2016. However, they also 
expressed concern with the fact that toys with CE marking were still being tested at three border 
points. 
2.261.  The representative of Turkey explained th at, after a comprehensive domestic consultation 
process, all verifications of toy imports at the bord er had ceased as of 2016 (including with respect 
to all verifications that have started in 2015). Besides, according to Communiqué 2016/10 of the 
Ministry of Economy, toys to be imported to Turkey were subject to risk analysis under the Risk Based Trade Control System (TAREKS). According to the Communiqué, import controls for toys through TAREKS were carried out electronically and on a risk basis. In other words, only products 
presenting a risk would be subject to safety and conformity checks. In this regard, he said that 
inspections were conducted as physical checks and controls, including document/marking checks. Products would be sent to accredited laboratories for testing only when there was doubt 
concerning product safety with respect to the framework given by the mentioned Communiqué. It 
was also noted that TAREKS took into consideration past performance and relevant data of the firms and products in the scope of risk assessmen t, as had been previously requested by the US. 
Turkey did not foresee any change to the risk-based implementation of the measure. 
2.2.3.37  Brazil - Draft Ordinance Act Nº. 374, 27 November 2014 (Portaria SDA/MAPA 
374/2014), G/TBT/N/BRA/613 (IMS ID 478) 
2.262.  The representative of the European Un ion noted that the Brazilian authorities were 
currently preparing a revised draft of the measure at issue, establishing quality requirements for 
wine and derivatives of grape and wine. The EU in vited the Brazilian authorities to take the EU 
comments from previous meetings into account during the revision process of the draft Ordinance, 
and in particular to consider aligning the draft Ordinance to international standards. In addition, 
the EU asked Brazil about the state-of-play of  the revision and whether the revised draft 
Ordinance, which would presumably undergo substantial changes, would be notified under the TBT 
Agreement and what the timeline for this notification would be. 
2.263.  The representative of Brazil noted that the measure was related to quality and identity 
standards on wine and other bi-products of grape. The measure, however, did not change the 
labelling and quality criteria currently in force, which were in accordance with MERCOSUR rules. 
The Brazilian Ministry of Agriculture had held a pu blic consultation about the measure at the end of 
2014, during which it reviewed all comments received from governments, the private sector and other interested parties (including from the EU). The results, he said, would be the object of a 
public hearing. Brazil did not believe the measure would have, or was intended to have, any 
impact on trade flows in wine between Brazil and its trading partners. Brazil was reviewing the EU comments that the standards regarding sugar conten t in wine also had some degree of flexibility 
with regard to OIV standards. Brazil also considered that the measure was aligned with 
international standards given the flexibility that such standards allowed in this area. Finally, he said that if there would be a need for a new notification, Brazil would submit one. 
2.2.3.38  China - Insurance Regulatory Commission (CIRC) Information and 
Communication Technology Regulation (IMS ID 489) 
2.264.  The representative of the United States recalled that her delegation had raised concerns in 
the previous TBT Committee meeting, with what seem ed to be a pattern on the part of the Chinese 
Government to impose "secure and controllable" requirements on ICT producers and service 
providers. These controls created disproportionate disadvantages for foreign ICT firms. Many relevant measures were not developed in a tran sparent manner nor gave sufficient opportunity for 
stakeholders to provide comments. Despite assurances to the contrary, China appeared to be 
working towards extending the "secure and controllable" policy to more and more sectors. She highlighted the importance of good communication and dialogue so as to ensure all measures in 
this area were adopted in an open and transpar ent manner. These measures should truly address 
the objective of the regulation, be aligned with international standards, and be no more trade 
restrictive than necessary. She requested China to limit its "secure and controllable" policies and related regulations to those areas where national security regulatory oversight was critical and G/TBT/M/68 
 
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  that those regulations be prepared in a transp arent manner where stakeholders were given at 
least 60 days to comment, and any comments be taken into account by the relevant agencies. Should such measures deviate from internationa lly accepted cryptography algorithms or other 
standards, she asked that they be notified to  the WTO. Concerning testing and certification 
requirements for encryption technology, she emphas ized the importance of avoiding testing which 
could be unnecessarily burdensome, discriminatory, or include a review of source code, or other sensitive business confidential information. Finally, she asked when China was planning to notify 
the Insurance Regulatory Commission's draft regulation on "the Informatization of Insurance 
Institutions" to the TBT Committee.  
2.265.  The representative of Canada supported the concerns raised by the United States and 
reiterated the concerns raised by Canada in the previous TBT Committee meeting to which 
responses were still being awaited. It was Canada's view that China's approach to "secure and 
controllable" ICT would decrease, rather than increase, the cybersecurity of China's network and insurance ICT infrastructure. With respect to the Draft Supervision Rules on Insurance Institutions 
Adopting Digitalized Operations, he requested furt her information on: (i) the definition and scope 
of what constituted "core systems" and how "national security" was defined in that context, and clarification on how this article would function in relation to the MLPS; (ii) how the provisions 
related to testing by third party institutions would be operationalized in Article 22; and (iii) if China 
could clarify whether Article 25(2) which described the security management mechanism requirements, including the use of technologies and products that complied with national standards and encryption requirements, was referencing other existing legislation or if the terms 
would be uniquely defined for those rules.  
2.266.  Canada also had concerns that the requirements in Article 31 could be overly restrictive for 
the intended purposes. This article indicated that when data was from within the territory of China, 
the data centres handling the information should be located within China. It also required that the 
design of the computing facility comply with nation al standards as well as the requirements of the 
China Insurance Regulatory Commission (CIRC). He sought clarification as to why these measures 
were thought to be necessary for the insurance sector in China. On Article 53 which provided 
guidelines as to the type of equipment and software that insurance institutions should consider purchasing (i.e. secure and controllable hardware  equipment and software products), he asked 
that China clarify whether foreign-made software and equipment would qualify under these draft 
regulations, and if not, could China explain why it was necessary to impose such limitations.  
2.267.  Article 54 highlighted the objective to work towards an "all-round application of domestic 
cryptography in the electronic insurance policy and insurance sector". Canada asked how this 
would work in practice and for any additional information about the objective. He requested 
clarification on the meaning of "indigenous IP protection" in Article 55, as well as information on CIRC's associated expectations regarding the implem entation and interpretation of this Article. On 
Article 56, he asked that China provide additional information on what level of security might be 
required, as it appeared to reference MLPS secu rity requirements but was non-specific, and could 
China indicate how this article would function in relation to Article 20, which also appeared to set out security requirements. Finally he requested China to provide additional information on the 
"security certification" process and asked whether China would be adhering to international 
standards of accepting third party test reports in this regard.  
2.268.  The representative of the European Union welcomed the statements made by the United 
States and Canada and in particular the requ est for an update on the ongoing review of 
stakeholders' comments. He requested that China carry out a substantive review of the draft guidelines in view of the comments received. On specific aspects of the draft, the EU fully 
concurred with the analysis made by the US and Ca nada in requesting an update on the timeline, 
the availability of the revised draft, and the notifi cation of such drafts. The EU continued to be 
interested in further bilateral engagement with China on this matter. 
2.269.  The representative of Australia said that  Australian industry and enterprises had a great 
interest in any potential regulations that might impact their ability to operate in the Chinese 
market. ICT and cybersecurity were global issues and to be most effective, required globally consistent solutions. Australia encouraged the use of internationally accepted approaches to 
encryption and ICT security, thereby minimizing conflicts across systems and ensuring best 
practices globally. He requested further information on the status of the regulations and specifically, on whether they would be notified to  the TBT Committee. He also sought clarification G/TBT/M/68 
 
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  on the definition of "secure and controllable ICT" in Article 53 as it was unclear what was expected 
of ICT systems so as to fulfil this criterion. 
2.270.  The representative of Japan supported the positions of previous speakers on this issue. 
She requested that China clarify the unclear articles such as terms definitions, concrete 
requirements for examination and evaluation. She asked what was the scope of the regulation and 
that China ensure transparency so that market access for foreign companies would not be hampered. The requirement to use Chinese national standards should be consistent with the 
principles of non-discrimination and should not be more trade restrictive than necessary. Like 
others, Japan asked for an update on the current status of the regulation in view of the requests by Members that their concerns be addressed in  the preparation of the regulation. Japan also 
asked when China would be notifying the measure to the TBT Committee.  
2.271.  The representative of China said that th e rapid development of information technology had 
led to new challenges in information security. Since 2013, cybersecurity had been strengthened 
globally including in China. The measures in question were developed so as to protect and 
maintain stable development of Chinese cybersec urity. She assured Members that the drafting 
process would be carried out in a transparent manner and that comments would be taken into consideration. 
2.2.3.39  Brazil - Toy Certificat ion; Ordinance No. 489, No. 310 and draft Administrative 
Rule No. 321, G/TBT/N/BRA/612 (IMS ID 478) 
2.272.  The representative of Canada considered that the above-mentioned measures imposed 
unjustified costs and delays to the toy industry without resulting in any measureable increase in 
consumer safety when compared to internationally recognized and robust certification systems 
already in place for toys. He urged Brazil to consider reviewing the ordinance where currently-valid registration numbers would not be terminated and permit a suppliers' declaration of conformity or 
sampling by any International Laboratory Accreditation Cooperation accredited laboratories. In this 
respect, he asked Brazil to clarify the purpose of the recently amended Administrative Rule 321, which required laboratories to document on film the actual testing of toys and make this video a 
mandatory requirement of the registration process. He also asked how the information storage and 
retention requirements (for example, keeping records for a minimum of five years) would enhance consumer safety. It was Canada's position that these requirements were unnecessary, overly burdensome, and would increase costs to exporters and consumers with no tangible benefits. 
2.273.  The representative of the European Union noted that draft Ordinance 489 aimed to 
consolidate all existing rules on conformity assessment, while Ordinance 310 dealt with the 
technical regulation part and aimed in particular to define the testing requirement for toys. With 
respect to the timeline, it was the EU's understanding that INMETRO was currently reviewing the 
comments received, including the representations made at the public hearing held on 4 August 2015 and the timeline for final adoption of both  ordinances was May/June 2016. The EU asked 
Brazil to confirm these understandings and also to indicate whether a final draft would be 
published with opportunities for stakeholders to provide feedback and comments before final adoption by INMETRO so that changes made to th e original draft could be properly assessed. He 
said that this would be necessary if certain comments were not taken into account in the final 
draft.  
2.274.  Regarding specifically draft Ordinance 489,  the EU was concerned with new requirements 
for registration of each toy model for traceability purposes. The EU wished to better understand 
the relationship between this new registration requirement and the actual conformity assessment 
process. In particular the following: who would be responsible for the registration? How long would it take for INMETRO to issue a decision or whatever other form of authorization that would be 
needed for the toy to be placed on the market? Why this type of registration was considered more 
adequate than a registration that would apply only for each producer and importer? This latter alternative, he said, could be coupled with a gene ral requirement for toy manufacturers to have an 
internal traceability system capable of tracking relevant data supply information, such as date and 
place of production and batch number, while leaving it to the manufacturer to decide which 
traceability methods would be most adequate for its business and product. This was the approach that had been adopted in the EU under the EU To y Safety Directive. The EU would be happy to 
provide further insight into the operation of the EU toy safety legislation in this area.  G/TBT/M/68 
 
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  2.275.  With respect to the draft amendment to Administrative Rule 321 of 2009, concerning the 
filming of toy testing, the EU asked Brazil to confirm if it was true that this requirement would be dropped. Finally, on the draft Ordinance 310, the EU requested Brazil to ensure coherence and no 
discrepancy between the testing criteria as define d in this Ordinance and that in the Mercosur 
MM300 series of standards for toy safety. 
2.276.  The representative of the United States aske d Brazil to explain why, rather than continuing 
with the current system, it had instead opted for an overly burdensome requirement for companies 
to register toys in a "family of products". She also asked Brazil to clarify: (i) whether the testing 
for new products would only have to be done to get certification; (ii) whether market samples would only be taken as a follow-up once products were on the market; and (iii) when the operator would eventually need recertification. She further asked if such issues were reflected in the 
different requirements for original sample testing versus maintenance testing. She also noted that, 
according to the Toy Industry Association, subjecting toys to INMETRO'S Object Registration System may increase costs for toy manufacturers. It was nonetheless unclear how these new 
requirements would yield increased consumer safety beyond the current system. One result might 
be a reduction in consumer choice in the market as many small and medium-sized enterprises and developing country exporters may be forced to abandon the Brazilian toy market altogether.  
2.277.  She said that the US was also concerned that the Ordinance would require manufacturers 
to release confidential business information to INMETRO. In this respect, she asked Brazil to explain why the additional documents were necessary and what confidentiality protections would apply. The combination of new requirements under Ordinance 489 imposed disproportionately 
severe costs and burdens on the toy industry beca use of the sheer number of products. The US did 
not understand how the proposed changes would result in any improvement in safety over the robust certification system currently in place for toys. 
2.278.  The representative of Brazil said that his country took children's safety issues very 
seriously. The measures had been in place for se ven years already. According to good regulatory 
practice, this was an appropriate time-frame for re vision and update of measures. He recalled that 
INMETRO had held a public consultation on the Ordinances in 2014 and was currently considering 
the inputs it had received, including some related to the points raised on this meeting, in order to prepare a final rule. He explained that the purpos e of the measure was, through the establishment 
of a registration procedure, to create a direct link between INMETRO and the producers as well as 
to facilitate access by consumers to certification information. This would, in turn, improve the 
Brazilian framework of conformity assessment in te rms of transparency and traceability. In this 
context, although practices differ from one country to another (e.g. the EU in its intervention has 
presented its system, an approach that was also of concern to Brazil), Brazil believed that the 
requirements of the measure conformed to international best practices.  
2.279.  Regarding the US concerns with the confid entiality of information submitted to INMETRO, 
he stated that this agency maintained a strict policy which was consistent with international 
standards, in particular ISO/IEC 17065 item 4.5. On the other specific comment related to registration, he said that in Brazil it was a legal requirement. Thus, the regulatory process was just reacting to such legal requirements, i.e. law 12.545/2011 and Decision 05/2008  by CONMETRO 
(the inter-ministerial council in charge of deliberating such issues). The toy sector was the last 
sector to adopt this system of registration, which had already been applied, without any difficulties, to other sectors in Brazil for some time.  
2.280.  On the US issue of sampling that was used in the process of conformity assessment, he 
explained that, as a member of the International Accreditation Forum (IAF), Brazil strictly followed IAF model No. 5. With respect to the filming and recording requirements, he said that while Brazil 
considered that such requirements enhanced consumer safety, it was also giving serious 
consideration to the comments that were made both in this Committee and in the public consultation process. Although Brazil could not ascertain the outcome of the ongoing regulatory process, he confirmed that Brazil was in this process of redrafting the rule towards a final rule 
giving very careful consideration to the comments and concerns presented in this forum. He also 
confirmed the EU's understanding on how this new regime of regulations was structured, i.e. whether these two rules would address different issues. In other words, Ordinance 489 would 
consolidate conformity assessment rules, while Ordinance 310 would cover testing requirements 
and technical regulations.  G/TBT/M/68 
 
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  2.281.  As regards the timeline for a final rule, he said that, while Brazil could not give a definitive 
answer, it expected to have a final rule by the mo nth of June 2016. In this regard, he also clarified 
that, in principle, his delegation did not believe it was necessary to issue a new draft before the final rule. This was because Brazil had already sign ificantly advanced in the regulatory process. A 
public audience after consideration of the written submissions in the course of the consultation 
process had already been conducted.  
2.282.  Finally, regarding the registration process, at this stage Brazil could only share with 
Members the assessment from the experience of other products and other sectors that there had 
not been any problems and that the benefits of this new system would far outweigh any eventual 
costs. Further, there had been neither delays no r any complaints from the experience of other 
sectors. Brazil committed to verifying this informat ion and to providing a more precise answer at a 
later stage. On the EU question regarding the syst em of certification by company or by kind of 
product, which was the approach that Brazil was adopting, he acknowledged the differences in approach from one country to another. Brazil beli eved that a system adopted by the EU worked for 
the EU. Brazil however also believed that it was right to follow in this case its own approach, which 
it considered would better serve its interests and needs in this area both in terms of transparency and traceability. 
2.283.  The representatives of the United States and Canada said that there had been significant 
problems with the registration system when it came to the medical device sector. Indeed, this had 
been discussed in the TBT Committee for quite some time. This was part of the reason the same issue was being raised with respect to toys.  
2.284.  The representative of Brazil said that with respect to certification procedures conducted by 
INMETRO there had been no complaints or difficulties in the registration mechanism.  
2.2.3.40  Colombia - Testing Requirements to be met by Toys and their Components and 
Accessories, G/TBT/N/COL/109, G/TB T/N/COL/109/Add.1 (IMS ID 479) 
2.285.  The representative of Canada expressed his delegation's concerns with the provisions 
contained in Article 12 of Resolution 3388 of Colomb ia's Ministry of Health and Social Protection. 
Canada was of the view that local testing and certification requirements for toy imports were 
discriminatory and at odds with Colombia's MFN and National Treatment obligations. This was particularly so given that Colombia was not accepting test results from overseas laboratories accredited by ILAC. Canada also believed that the proposed 50 ppm total lead limit was unrealistic 
and was not aligned with currently accepted international standards. By way of comparison, 
requirements of other leading jurisdictions varied from 90 to 600 ppm. Canada believed that achieving 50 ppm would be difficult given that le ad was a naturally-occurring element, which was 
also present due to erosion. Scientific evidence indicated that even the purest soil in wilderness 
areas contained approximately 40 ppm of lead and several hundred ppm  was not uncommon in urban areas. Canada also believed that the labelling provision would lead to unnecessary consumer 
concerns and would add costly processing steps for companies selling products which did not pose 
a risk from lead. Canada thus recommended that Colombia adopt a lead limit aligned with international standards. 
2.286.  The representative of Mexico said that, wh ile her delegation supported the right to protect 
consumers through regulatory instruments, it al so believed that there were alternate ways to 
attain this objective through less costly processes. Under the proposed amendments, before the marketing and inward clearance of toys, as well as their components and accessories, domestic 
producers and importers of these items must obta in the corresponding certificate of conformity. 
Article 12 provided three alternatives for obtaining the certificate of conformity, all of which, in Mexico's opinion, contravened Article 5.1.2 of  the TBT Agreement. This was because these 
alternatives imposed additional costs, arising, for example: (i) from having to take a certifier to 
the place where the tests were to be conducted; (ii) from having to translate the certificates into Spanish under certain circumstances; and (iii) from admitting that there may be a low level of certainty regarding certification using standards that would appear to be considered equivalent. 
Broadly speaking, she said, the foregoing entailed the submission of "third-party" certificates of 
conformity for toy industry products. This caused considerable delays in the import process. In light of the foregoing, she requested Colombia to provide the scientific and technical justification 
for the adoption of this certification requirem ent and to consider amending Decree No. 1471 of 
2014 or exploring mechanisms for concretely determining conformity alternatives.  G/TBT/M/68 
 
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  2.287.  In additional to the above considerations, Mexico also had the following three points of 
concern: (i) with respect to Article 2.2.1.7.6.6 ( Risk Levels ), she noted that, previously, there 
were three different levels of risk. However, the fact that there were currently two risk levels 
increased the likelihood of a third-party conformity certificate being required; (ii) with respect to 
Article 2.2.1.7.9.2 ( Procedure for Assessing the Conformity of Products ), she stated that this 
provision still left scope for discretion entailing costs and giving rise to uncertainty for economic operators; and (iii) with respect to Article 2.2.1.7.9.5 ( Laboratory Testing ), she stated that, in her 
delegation's view, the conclusion to be drawn from this provision was that, sooner or later, all 
tests would have to be conducted in Colombia. Mexico therefore asked Colombia to provide some justification for this requirement. 
2.288.  The representative of the United States requested Colombia to notify the measure at issue 
to the TBT Committee, and allow interested parties an opportunity to comment, as had been 
previously indicated by Colombia. She called Colombia's attention to the fact that ILAC signatories committed to accept test results from ILAC accredited laboratories, regardless of location. 
Therefore, given that ONAC ( Organismo Nacional de Acreditación de Colombia ) was now an ILAC 
signatory, Colombia should consider the acceptance of test results from ISO/IEC 17025 accredited 
laboratories for toy safety testing. She recalled that during the US-Colombia bilateral meeting in 
December 2015, Colombia had noted that in-country testing requirements stemmed from a lack of confidence in foreign third-party certification bodies. She asked Colombia whether US' further explanation of how its accreditors participate in ILAC had alleviated those concerns that had been 
voiced bilaterally. She also noted that other WTO Members that had also been subjected to similar 
in-country testing requirements to toy imports had faced severe delays for imported products. As toys from compliant companies become more expensive, consumers may look for alternatives in 
the grey market, including illegal imports. This, she said, could result in safety risks.  
2.289.  The representative of Colombia thanked Mexico and the US for the opportunity of 
explaining bilaterally the measures that Colombia took in relation to Resolution 3117 of 2015, 
adopted by the Ministry of Health and Social Protection. He explained that Resolution 3117 
modified Resolution 3388 of 2014, which had alread y been notified to the WTO and that another 
new technical regulation would be notified within the coming days. This new draft measure would derogate from Resolution 3117 by granting 90 days for comments. These comments would then be 
considered by the regulatory authority. 
2.2.3.41  Korea - Standards and Specificat ions for Wood Products, G/TBT/N/KOR/563, 
G/TBT/N/KOR/599 (IMS ID 491) 
2.290.  The representative of the United States  said that there was growing concern among US 
wood product manufacturers and exporters that Korea's standards would effectively close US 
products out of the market unnecessarily. Would Korea accept product certification by an ISO 
17025 accredited body? There was also growing concern that even if US companies could 
eventually comply with the new Korean standards, there was no mechanism to certify to the Korean standards outside of Korea. Could Korea explain how it would allow conformity assessment to be conducted in the territories of other WTO Members?  
2.291.  The US representative was also concerned that since the new standards were not 
performance-based, it would mean that higher-performing products would become too expensive for Korea's construction industry. For example, without a specific performance standard for 
Oriented Strand Board (OSB) that was meant for structures, construction firms would be 
incentivized to buy the lower priced OSB and create buildings that could unnecessarily endanger Korean consumers. In previous interventions, th e United States had made general requests, such 
as on performance-based standards and consideration of less trade-restrictive measures. However, 
in order to help Korea understand what it entailed to prevent unnecessary trade barriers, and address Korea's consumer safety concerns, the United States now made the following specific requests: (i) that the Korea Forest Service reco gnize the U.S. Department of Commerce (DOC) PS 
1 standard grade with the Korea Forest Research Institute structural plywood standard and did not 
require on-going testing on a per lot basis at the port of entry in Korea when the products have been marked in accordance with PS 1 by a recogn ized US certification body; (ii) that the Korea 
Forest Service recognize American National Standards Institute (ANSI) grade with the Korea Forest 
Research Institute structural glulam standard an d did not require on-going testing on a per lot 
basis at the port of entry in Korea when the products had been marked in accordance with the 
ANSI glulam standard by a recognized US certification body; (iii) that the Korea Forest Service G/TBT/M/68 
 
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  recognize U.S. Department of Commerce (DOC) PS 2 standard within the Korea Forest Research 
Institute oriented strand board standard, recognize grades and span ratings for construction applications, and did not require on-going testing on a per lot basis at the port of entry in Korea when the products had been marked in accordance with PS 2 by a recognized US certification 
body; (iv) that the Korea Forest Service recognize the voluminous data already gathered related to 
negligible formaldehyde emissions for the above pr oducts and did not require on-going testing on 
a per lot basis at the port of entry in Korea when the products had been marked in accordance 
with PS 1, PS 2, or the ANSI glulam standard by  a recognized US certification body; (v) that the 
Korean government pass the Foreign Quality Inspection Institute Law and grant US entities having appropriate credentials (such as ISO 17065) FQII status; and (vi) that Korea delay implementation of all mandatory standards until there was an effective method of recognizing conformity 
assessment conducted outside of Korea.  
2.292.  The representative of Canada noted Korea' s ongoing efforts to work with Canadian trade 
and forestry officials to resolve issues related to a number of forest-product standards and said 
that Canada had similar concerns related to the standards mentioned by the US, the new standard 
for OSB in particular. Korea was basing its new OSB standard on an ISO standard that was explicitly indicated not to be used for structural design, and which was based upon property 
testing rather than performance testing. The representative of Canada asked Korea to take into 
the account the fact that OSB in Korea was primarily used for structural applications. Canada asked Korea to reconsider its new standard to address the performance requirements of OSB used for structural purposes and recognize that the North American OSB, which encompassed the 
majority of the product in this market, should continue to be allowed in Korea based upon its well-
known quality, safety and reliability. He also aske d that Korea continue to accept OSB tested and 
graded in North America in accordance with Cana da's rigorous and time-tested quality assurance 
systems. It was Canada's understanding that the new regulation's requirement to test and inspect 
this product in Korea would lead to lengthy and expensive delays given that similar quality-assessment systems were not currently in place in Korea.  
2.293.  The representative of the Republic of Korea stressed that Korea had attempted to collect 
opinions from stakeholders and experts during the development course of quality standard of wood 
product to secure transparency. Korea was currently preparing a procedure for the designation of Foreign Quality Inspection Institute (FQII) for the acceptance of test report issued by foreign 
testing bodies. Regarding the OSB test criteria issues, and the recognition of the US domestic 
standards issues, Korea would convey these concerns to the relevant ministry in capital for consideration. 
2.2.3.42  European Union - Proposal for a Dire ctive of the European Parliament and of 
the Council on the Cloning of Animals of the bovine, porcine, ovine,  caprine and equine 
species kept and reproduced for farming purp oses (197) and Proposal for a Directive of 
the European Parliament and of the Council on the Cloning of Animals of the bovine, 
porcine, ovine, caprine and equine specie s kept and reproduced for farming purposes 
(198), G/TBT/N/EU/197, G/TBT/N/EU/198 (IMS ID 492) 
2.294.  The representative of the United States expressed concern regarding the cloning measures 
currently under consideration by the European Union as they could be more trade restrictive than 
necessary and might not fulfil any legitimate objective the EU may have. She said that the amendments adopted by the European Parliame nt expanded the scope of the Commission's 
original proposals, as notified in G/TBT/N/EU /197 and G/TBT/N/EU/198, to include all farmed 
animals, including poultry and fish. It also sought to make the restrictions permanent rather than temporary. There were substantial trade implications for imposing bans or labelling requirements 
on animal clones, their genetics, their sexual ly-reproduced offspring and descendants, and the 
edible food products derived from such animals. Further, there did not appear to be any scientific 
or other legitimate rationale for the EU to impose restrictions on food from cloned animals, let alone on food or products from the descendants of cloned animals. Both the US Food and Drug 
Administration (FDA) and the European Food Safety Authority (EFSA) had concluded that meat and 
milk from cow, pig, and goat clones and the offspring of any livestock clones presented no food safety risk. Indeed, EFSA had also explicitly noted that there was also no scientific evidence that 
suggested a risk to genetic diversity, biodiversi ty, or the environment from farmed clones in 
comparison to conventionally farmed animals. G/TBT/M/68 
 
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  2.295.  In addition, she noted that the Internatio nal Embryo Transfer Society (IETS) had published 
guidelines for the health assessment and care for animals involved in the cloning process. This guidance detailed the recommended care for cattle, swine, goat, and sheep clones and surrogates to protect the welfare of the animals. These guide lines for the protection of animal welfare were 
met or exceeded by the cloning industry in the Un ited States. The United States also stressed that 
this issue was not limited to the US, but a world-wide one. Descendants of clones were almost certainly in every country that imported genetics.  US trusted the EU recognized that their own 
herds were not free of descendants of clones – and it was critical that EU measures did not unfairly 
disadvantage imports.  
2.296.  The US noted the potential burden that would be imposed if the European Parliament's 
amendments became law. It was not possible to test if an animal was descended from a clone as 
cloning left no genetic signature that allowed th ese animals to be distinguished from descendants 
of the original, thus creating the need for extensive traceability requirements that did not exist in many countries today. The United States hoped that the EU would be able to address US concerns 
by avoiding measures that failed to recognize the relevant science, that discriminated against 
imports, and that were unlikely to fulfil any legitimate objective. 
2.297.  The representative of Brazil said that it  was currently reviewing the proposed EU Directive 
but at this point it associated itself with the concern just raised by the US.  
2.298.  The representative of the European Union noted that the draft proposals had been adopted 
by the Commission late in 2013 and had been no tified to the TBT Committee in March 2014. The 
first Directive (Proposal for a Directive of the European Parliament and of the Council on the 
Cloning of Animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced 
for farming purposes (197)) would prohibit the use of the cloning technique in the EU for 5 species likely to be cloned for farming purposes and the import of live clones produced in third countries. 
The second Directive (Proposal for a Council Directive on the placing on the market of food from 
animal clones (198)) would prohibit the placing on the market of any food from clones. It was also mentioned that upon completion of the first read ing on the first Directive in September 2015, the 
European Parliament proposed to merge both proposals and to extend the aggregate ban to 
reproductive material from clones, descendants of clones and products thereof. In addition, a traceability system that would extend to third-country trade partners was requested. The European Commission maintained its proposals. The next procedural step was the Council 
Common Position. 
2.2.3.43  China - Interim Measures for Quality Management of Commercial Coal, 
G/TBT/N/CHN/1057 (IMS ID 477) 
2.299.  The representative of Canada said that while his delegation appreciated China's objective 
of decreasing air pollution, he remained deeply concerned about China's interim measures for 
quality management of commercial coal. It was important to ensure that China's coal testing 
procedures were consistent with its international trade obligations. In order to treat both domestic 
or foreign coal producers equally, Canada urged China to reconsider its position with respect to requiring testing to be performed in China as  both Canada and China were members of the 
International Laboratory Accreditation Cooperation (ILAC) and trusted the expertise of ISO 
accredited inspection services and test labs, which were recognized worldwide. China did not 
currently recognize the results of ISO 17025 accred ited testing labs and independent third party 
ISO 17020 accredited inspectorate services at the ports of loading in foreign coal producing 
countries. Canadian coal companies already used internationally recognized coal inspectorate 
services. If pre-inspection in Canadian ports of loading was accepted by China, it would not only avoid duplication of testing in Canada and in China, but would also alleviate the burden on Chinese 
inspectorate services and significantly reduce delays in clearing shipments in Chinese ports, which 
was a net benefit for all parties. Accepting pre-shipment results would permit China to more effectively implement and assess its air pollution reduction measures. In addition, Canadian stakeholders had questioned whether Chinese dome stic coal was subject to the same inspection 
procedures as imported coal. Therefore, addition al information with respect to China's testing 
procedures for domestic coal versus imported coal was requested to help manage Canadian stakeholders' concerns. The representative of Canada welcomed China's consideration to allow coal 
pre-inspection in some foreign ports of loading and encouraged China also to allow third-party 
testing in all coal exporting countries. In addi tion, Canada requested some clarification with 
respect to China's comments from the November 2015 TBT Committee meeting on its G/TBT/M/68 
 
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  methodology for assessing the effectiveness of the human health and environmental safety 
aspects of the commercial coal testing regime. 
2.300.  The representative of Australia noted that China was Australia's second largest coal export 
market and there continued to be great interest from the Australian industry and exporters 
regarding the implementation and application of this measure. Australia further expressed support 
for the environmental objective of improving air quality and promoting the efficient and clean use of coal, and Australia remained committed to being a reliable supplier of high quality thermal and 
metallurgical coal to China by supporting China's efforts to improve the quality of coal used in 
China's energy and industry sectors.  
2.301.  Nevertheless, Australia noted some concerns  with the regulation in the following areas. 
First, regarding the time-frame – what was the reason for notifying the measure to the TBT 
Committee as "urgent" under Article 2.10 of the TB T Agreement, and was the measure still interim 
as had been stated in the notification? Second, on standards: China had based the standard in the interim measure on globalCOAL's Standard Coal Trading Agreement. However, Australia requested 
China to consider using existing international standards such as ISO 13909. Australia requested 
the reason for using the globalCOAL standard Coal Trading Agreement standard rather than the ISO standard. Further details of the globalCOAL's Standard Coal Trading Agreement and its 
application to domestic and imported coal were also requested. 
2.302.  Third, on conformity assessment procedures, Australia urged China to accept test results 
undertaken in other countries at internationally accredited testing facilities to reduce duplication and enable tests to be undertaken in a more expeditious manner. The information about 
interaction between national accredited testing authorities to discuss test results obtained in China 
where those test results differ from results obtained elsewhere was requested.  
2.303.  Fourth, Australia raised some concerns ab out the review or appeal process to question 
cases of Chinese test results differing from Australian or other countries' test results. Australia 
wanted to know whether China gave any consideration to an independent review or appeal process in the case of differences in results between tests conducted outside China and at Chinese ports, 
or different results between test s at different Chinese ports, on the same shipment of coal.  
2.304.  In addition, Australia expressed the following further concerns: (i) on the testing procedure 
of Chinese domestic coal and on consistency between testing conducted on imported coal and domestic Chinese coal; (ii) on the results of the tests conducted for domestic coal which had been 
undertaken so far; (iii) on what happens to domestic coal that did not meet the quality standard; 
and, (iv) on the consistency of testing across all of the import ports. Australia also requested an update on any improvements to timeframes and capa city for testing imported coal after arrival in 
China. Finally, Australia asked when it could expect a formal response to its comments on the 
measure to China's TBT enquiry point that had been set forth at the last meeting of the Committee.  
2.305.  The representative of China stressed that the interim measures for quality management of 
commercial coal had been adopted in response to the severe air pollution situation in China. It was 
noted that just last week China had suffered four days of serious haze in Beijing. The main cause of the haze was the excess of PM 2.5 which had a direct connection to the increase of coal 
consumption in China. As China did not have further information to respond to Members' concerns 
it invited Members to refer to the minutes of the November 2015 meeting. 
2.2.3.44  China - Guidance for Notificati on and Registration for New Chemicals, 
G/TBT/N/CHN/1170 (IMS ID 490) 
2.306.  The representative of the United States thanked China for their bilateral meeting as well as 
the recent notification to the TBT Committee but also indicated that her delegation continued to 
have concerns regarding the Notification and Registration of New Chemicals in China. The US 
urged China to take all stakeholder comments into consideration and the Solid Waste and Chemical Management Technology Center (SCC-MEP)  to continue seeking stakeholder input as it 
further developed China's chemical registration requirements. The chemical registration 
requirements, which came into effect in October 20 10, were in many cases difficult to understand 
and imposed very significant administrative and compliance burdens. While the Guidance was a G/TBT/M/68 
 
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  welcome effort to address these issues, the Guidance itself raised a series of troubling concerns. In 
particular, the new language in Chapter I(1)2.4 on articles exempted from the New Chemical Notification (NCN) Guidance implied that any new chemical substance in an article, potentially having exposure to humans or the environment, wo uld be subject to the full NCN obligations as 
per Decree Number 7. Specifically, this requirement would be applicable to all articles and their 
subcomponents, even if there was extremely low r i s k  o f  h a z a r d  o r  e x p o s u r e  t o  h u m a n s  o r  t h e  
environment and would not only impose significant administrative and compliance burdens on 
industry, but also impose a new administrative burden on the SCC-MEP itself, significantly 
increasing the number of applications it would have to review. US industry recommended that SCC-MEP maintain the previous version of the Article Exemption, under which articles and substances used in or released by articles, were exempt as they posed negligible risk to human 
health or the environment. Otherwise, the provis ion could potentially place an undue burden on 
manufacturers in China, as well as importers into China. Global suppliers to Chinese importers would be required to proactively inform their Chinese customers of substances new to China that 
may be contained in or released from their manuf actured articles, placing a significant burden on 
manufacturers since they would have to ensure that substances were notified, resulting in 
amplified implications throughout the global supply chain, including on Chinese companies. 
Further, such requirements could impact global suppliers' future decisions to export substances 
and articles to China due to the increased administrative burden as well as the possibility of disclosing sensitive Confidential Business Information to customers.  
2.307.  The representative of China said that th e revision of the Guidance for Notification and 
Registration for New Chemicals had begun in January 2014 and that the public consultation had 
taken place between 25 June and 31 July 2015. China had already introduced some changes to the Guidance, notified as G/TBT/N/CHN/1170, based on Members' comments and would continue to 
take Members' comments into consideration. 
2.2.3.45  Saudi Arabia - Draft for update  of the Technical Regulation No. SASO 
2857:2014 "Vehicle Tires Rolling Resistan ce and Wet Grip Requirements", 
G/TBT/N/SAU/835 (IMS ID 488) 
2.308.  The representative of Korea said that his delegation appreciated the active attempts by 
Saudi Arabia to improve the draft for update of the technical regulation on vehicle tyres rolling 
resistance and wet grip requirements; however, Korean companies continued to have difficulties in 
observing the regulation. First, the regulation specif ied that the validity period for the energy label 
was one year, putting financial and administrative burden on Korean companies to renew the label annually. Saudi Arabia was the only country requiring the renewal of the energy label when 
compared to other countries such as Europe, Brazil, Korea, etc., which enforced energy efficiency 
labelling requirements for tyres. Referring to Ar ticle 2.2 of the TBT Agreement, which specified 
that "…technical regulations are not prepared, adopted or applied with a view to or the effect of 
creating unnecessary obstacles to international tr ade", Korea requested Saudi Arabia to withdraw 
the validity period for energy labels. 
2.309.  Second, Korea requested Saudi Arabia to improve on the procedures, which required 
companies to go yet again through the registration procedure, obtain a new certificate and pay 
fees when they modified basic information, such as model name. Lastly, since the certification 
system was divided into two stages, namely application for registration and issuance of label, Korean companies had to pay fees at each stage and go through local branches in Saudi Arabia to 
pay these fees since it was not possible to pay thro ugh direct wire transfers from Korea. In this 
context, Korea requested Saudi Arabia to improve the process of certificate registration and support the oversea remittance procedure so that companies could remit total acquisition fees 
from foreign countries at one time.  
2.310.  The representative of the European Union said that his delegation had raised concerns 
about this draft, both when it was first notified  as G/TBT/N/SAU/835 and also when notified in a 
revised version as G/TBT/N/SAU/907. The EU had submitted written comments to Saudi Arabia on 
both notified drafts and had also raised the issue during the previous meeting of the TBT 
Committee.34 This time, the EU wished to raise both some new concerns arising from the version 
notified under G/TBT/N/SAU/907 as well as some which persisted since the earlier notification. 
Regarding the new version of the text, the EU noted that several of its provisions were not in line 
                                               
34 G/TBT/M/67, para. 2.49. G/TBT/M/68 
 
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  with relevant international standards and asked Saudi Arabia to fully align the notified draft with 
international standards, especially with UNECE Re gulation 117. The EU also noted that the label 
specified in the latest version of the notified draft as "Tire Rolling Resistance and Wet Grip Label Dimensions and Color Scale" contained changes and sought confirmation that the new version of 
the label would be the applicable one. Regarding issues the EU had already raised in the past, the 
EU highlighted that the notified draft defined the timeline for compliance with phase I maximum limits for C1 and C2 tyres as November 2015. Th e EU asked whether this requirement was already 
in force and whether its time-frame could be aligned with the one set for C3 tyres, namely 
November 2016. Furthermore, as C3 tyres were normally used by professional users, the EU asked Saudi Arabia to consider exempting them from the requirement to be labelled in the form of stickers on tyres.  
2.311.  The EU had also been informed about a new Gulf Cooperation Council (GCC) measure 
concerning tyre labelling. In this respect, the EU sought clarification on the existence and application of such a scheme in Saudi Arabia, on whether both the labelling obligation of the 
notified draft and that of the GCC measure were applicable and mandatory in Saudi Arabia and on 
whether there were concrete plans for a transition towards a unique GCC tyre labelling system. Finally, the EU asked Saudi Arabia to notify all implementing measures, including the recent 
"Regulation for procedure of data registration and issuance of the energy efficiency labels in 
vehicles and tires". In relation to this measure, the EU also inquired about the reasons and justification as to why the licence to print and use the labels was only valid for one year even if the tyre model had not undergone any change in the meantime. 
2.312.  The representative of the Kingdom of Saudi Arabia thanked the EU and Korea for the 
bilateral meeting and asked for the comments to be  provided in writing so that they could be 
forwarded to the capital for follow up. 
2.2.3.46  European Union - Restriction on Po lycyclic Aromatic Hydr ocarbons (PAHs) in 
Tyres as specified in Annex XVII of REACH (IMS ID 480)  
2.313.  The representative of China said that his delegation was mainly concerned about the test 
method ISO 21461 (Rubber — Determination of aromaticity of oil in vulcanised rubber 
compounds), which was referenced in Entry 50 of Annex XVII of REACH (1907/2006/EC). ISO 21461 was testing aromaticity of oil and was not specific to BaP and the 8 listed PAHs. The conformity assessment method referred to in this Entry specified that bay protons should not 
exceed the limit of 0.35 % as tyres measured and calculated by ISO 21461. There was no specific 
scientific correlation between Bay protons not exc eeding 0.35% of tyres on the one hand and BaP 
not more than 1 mg/kg, 8 listed PAHs not more than 10 mg/kg of extender oils, on the other. 
Therefore, it was not suitable for accurate quantita tive testing of BaP and 8 listed PAHs in extender 
oils. According to research by relevant Chinese institutes, tyres were produced from various raw 
materials and consisted of diverse and complicated substances. The influencing factors on ISO 
21461 testing results were far beyond extender oils and far beyond BaP and 8 listed PAHs. China's 
concern was neither the limits of PAHs nor the international standard ISO 21461 but rather that ISO 21461 was not suitable for use in conformity assessment of Entry 50 as it was an unusual and indirect quantitative method for the determinatio n of PAHs. By comparison, GC-MS and HPLC, test 
methods specified in several technical regulations and international standards, were more accurate 
and mature methods to determine PAHs. For these reasons, the use of the test method ISO 21461 
was unscientific, inappropriate and could cause misl eading test results. In fact, there had been 
several cases of Chinese tyres found non-compliant  with REACH, after being tested according to 
this standard. But they were compliant tyres if tested according to other more accurate, mature and commonly used test methods such as GC-MS and HPLC. Furthermore, China was very 
concerned about the huge costs of the test method to tyre manufacturers as it required testing 
laboratories to be equipped with very expens ive and unusual instruments such as the 200 MHz 
NMR spectrometer. China requested the EU to prov ide the scientific rationale for the test method 
ISO 21461, conduct a timely review and make relevant revisions accordingly. 
2.314.  The representative of the European Union indicated that the measure in question had been 
notified under the TBT Agreement on 21 Ja nuary 2004 as G/TBT/N/EEC/52 (so called REACH 
regulation) and that it had been extensively discu ssed with the WTO Members, economic operators 
and other interested stakeholders. Concerning the me thod for determination of aromaticity of oil in 
vulcanised rubber compounds (ISO 21461), he pointed out that the EU had been applying this method – an international ISO standard - since January 2010. Furthermore, the equipment needed G/TBT/M/68 
 
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  (nuclear magnetic resonance spectroscopy) was an instrument typically available in specialized 
laboratories. 
2.2.3.47  India - The Stainl ess Steel Products (Qualit y Control) Order, 2015, 
G/TBT/N/IND/50 (IMS ID 486) 
2.315.  The representative of the European Union informed the Committee that his delegation had 
submitted written comments on the draft Stainless Steel Products (Quality Control) Order on 23 
October 2015. He reiterated the statement made at the previous meeting.35  
2.316.  The representative of India thanked the EU for their continued interest in the draft 
Stainless Steel Products (Quality Control) Order. This draft order was published on the Ministry of 
Steel website and notified to the WTO on 25 August 2015, giving 60 days for comment. Several representations had been received from domestic and foreign producers, associations and other 
stakeholders, both in support of, and against the measure. The Ministry for Steel was currently 
examining all comments, on their merit, and would accordingly take those comments into consideration before making a final decision on the draft Order. 
2.2.3.48  Russian Federation – Measure affect ing import of Ukrainian wallpaper (IMS ID 
476) 
2.317.  The representative of Ukraine reiterated his delegation's concerns with regard to the ban 
on import of Ukrainian wallpaper to the Russian Federation (Russia). He noted that Russia had 
stated that Ukrainian products were non-compliant with Russian sanitary and hygienic technical regulations for emission of formaldehyde and styrene. He argued that the measure was applied in a non-transparent and unpredictable manner because it did not provide any evidence for the 
alleged inconsistency with Russia's requirements. Ukraine emphasized that the ban affected 80% 
of Ukrainian wallpaper producers who exported more  than 70% of their production to the Russian 
market. Moreover, Ukrainian producers had provided the Russian authority (Rospotrebnadzor) with 
all necessary documents and results of the tests carried out in Russian and Ukrainian laboratories 
qualified by the Russian Federation accreditation body, which confirmed the compliance with relevant technical regulations, including the requirements for emissions such as formaldehyde and 
styrene.  
2.318.  His delegation believed that the import ban was discriminatory as it treated Ukrainian 
wallpaper less favourably than like products of national origin as well as like products originating from other countries. Ukraine reiterated that the measure was inconsistent with provisions of 
Articles 2.1, 2.2 and 5.1 of the TBT Agreemen t, and in no way justified and created an 
unnecessary obstacle to trade. Consequently, Ukra ine requested the Russian Federation to provide 
official detailed clarification and justification of the measure and its compliance with the provisions 
of the TBT Agreement. He stressed that no test reports – which would confirm the wallpaper safety 
discrepancy with requirements – had been provided  to Ukraine by Russia, including in the letter 
received from Rospotrebnadzor. Moreover, no de ficient test reports had been provided to the 
Ukrainian manufacturers, making it hard or im possible to undertake, if necessary, corrective 
action. Ukraine called upon Russia to immediately withdraw the ban and bring this measure in line with the TBT Agreement and the accession commitments made by Russia. 
2.319.  The representative of the Russian Federation regretted to report that no progress had been 
made in the resolution of this matter. He said that no actions had been taken by Ukrainian 
authorities since the previous TBT Committee meeting to resolve this issue in a constructive manner. He referred to Russia's previous statements which clarified the legal basis for introducing 
this measure, its legal nature, and further steps th at were necessary for removing the measures at 
issue. First, he recalled that the import suspension of Ukrainian wallpaper had been introduced by the Russian Federation in April 2015, due to violatio n of the hygienic requirements on migration of 
formaldehyde and sterol into air. He underscored that measures were introduced with respect to 
products of a limited number of Ukrainian entiti es, and were temporary in nature. Accordingly, 
Russia informed the Sanitary and Epidemiological Service of Ukraine and the interested enterprises about the need to provide additional materials in the Russian language. Moreover, two bilateral 
meetings with Ukrainian producers concerning this  matter were held in June and September 2015, 
                                               
35 G/TBT/M/67, para. 2.40. G/TBT/M/68 
 
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  but until now Ukraine had failed to provide the Russian authorities with the required 
documentation. 
2.320.  Second, with respect to provision of test re sults, he informed that in accordance with Law 
№ 294-FZ of 26 December 2008, this information could not be delivered to any private person or 
legal entity with exception of those entities which were under inspection, in order to protect the 
commercial interests of such entities. Neither Russian, nor foreign, producers could receive this highly sensitive information. Taking into account that the inspections took place in respect of 
Ukrainian wallpaper traders, only they had the right to receive these results. Finally, he noted that 
his delegation responded to the Ukrainian reques t of July 2015 regarding this matter, received 
through the Ukrainian TBT enquiry point. Russia reaffirmed that these measures were in full compliance with the commitments of the Russian Fe deration and with Articles 2.1 and 2.2 of the 
TBT Agreement, and that the requirements on mi gration of chemicals into air were based on 
relevant scientific and technical information. 
2.2.3.49  United Kingdom – Proposal to intr oduce plain packaging of tobacco products, 
G/TBT/N/GBR/24 (IMS ID 424) 
2.321.  The representative of Indonesia appreciate d the United Kingdom's (UK) notification on the 
proposal to introduce plain packaging of tobacco products and for their written response from the 
previous meeting, which was sent to the Indone sian TBT enquiry point. Indonesia agreed with 
what was mentioned in the written letter that in order to protect public health, WTO Member may introduce provisions on standards. However, Indo nesia was of the view that the plain packaging 
policy requirements were inconsistent with the respective countries' obligation under the WTO TBT 
Agreement and TRIPS Agreement. The proposal for plain packaging policy for tobacco products as 
introduced by the UK should be undertaken in a manner that was not more trade-restrictive than necessary, as it could subsequently create unnecess ary barriers to trade. As Members were aware, 
plain packaging measures to pursue the public health objective of a certain Member were now 
being challenged by Indonesia and several other Members in the DSB. Therefore, Indonesia urged 
the UK and other Members in the process of introducing similar measures to reconsider their 
intentions until the dispute was solved. Indonesia requested that other Members evaluate 
alternative measures which were more effective in achieving the health objective, and more importantly, consistent with WTO rules. Indonesi a appreciated the opportunity to present its views 
on plain packaging regime and its consistency with the TBT Agreement. 
2.322.  The representative of the Dominican Repu blic shared the concerns of Indonesia. She 
requested that Members considering introducing plain packaging for tobacco products wait for the 
dispute to be resolved, as Dominican Republic and other developing Members had lodged this 
before the DSB against Australia on similar measures. 
2.323.  The representative of Guatemala shared th e objectives related to the control and reduction 
of tobacco consumption. Nevertheless, Guatemala also shared the concerns of other Members with 
regard to how this measure could fulfil the legitimate objective of reducing tobacco consumption 
without being more trade-restrictive than necessary to achieve that objective. She said that Guatemala followed with great interest the discussion about this measure. 
2.324.  The representative of Cuba agreed with Indonesia and the Dominican Republic in asking 
other Members to wait for the results of the pa nel with regard to the case lodged by many 
developing countries. 
2.325.  The representative of Australia reiterated its strong support for the decision by other WTO 
Members to legislate for the mandatory plain packaging of tobacco products. In particular, he 
welcomed the passage of legislation to implemen t tobacco plain packaging in the UK which would 
come into force later this year. The important steps made by these WTO Members in tobacco 
control demonstrated that efforts to delay the adoption of tobacco plain packaging measures in 
these countries had not been successful. He stat ed that Australia was of the firm view that 
Members had the right to implement measures necessary to protect public health, while complying with relevant international treaty obligation s, including the TBT Agreement. Tobacco plain 
packaging was a legitimate measure, designed to achieve a fundamental objective – the protection 
of human health. The tobacco plain packaging measure was endorsed by leading public health experts as well as the World Health Organization and was supported by extensive peer-reviewed G/TBT/M/68 
 
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  research, reports and studies. Australia further no ted that Members were making reference to the 
case currently before the DSB. It was inappropriate in Australia's view for complainants in WTO disputes currently under way against Australia to invoke these proceedings as an attempt to delay or discourage other Members from developing or implementing their own legitimate tobacco 
control measures.  
2.326.  The representative of Canada reiterated his delegation's statement under new STC no. 6. 
He said Canada was a pioneer in package labelling requirements for tobacco products and he 
considered these requirements to be a core compon ent of the right to regulate in the interest of 
the Canadian public. Tobacco use was a significant concern in Canada and worldwide, and in Canada alone 37,000 people died annually from tobacco use. It was a leading cause in Canada of preventable death and disease. Tobacco products were also the only good that was subject to a 
legally binding health treaty – the WHO FCTC. The Government of Canada had undertaken to 
introduce restrictions on the packaging of tobacco products very similar to those that the UK was proposing to adopt and Canada was considering measures implemented elsewhere in the world 
and their potential application in Canada. 
2.327.  The representative of Norway signalled No rway's continued strong support to the UK in 
their efforts to combat the tobacco epidemic. She also echoed the comments made by Australia 
and Canada and reiterated her delegation's statement under new STC no. 6. As tobacco smoking 
was the leading single cause of early death and illness in Norway, there was strong support for tobacco control measures so as to achieve a tobacco-free society in the long term. Norway had launched a public consultation on standardiz ing tobacco packaging in March 2015 and the 
preparation of the bill was now in the final stages. This bill would soon be sent to the parliament 
and most likely be adopted towards the end of 2016. 
2.328.  The representative of Uruguay said that given Uruguay's well-known position in support of 
tobacco plain packaging measures, the statements made by his delegation in previous meetings 
should be also be taken into account on this measure, including Uruguay's statement in the March 2016 Committee meeting.
36  
2.329.  The representative of the European Union thanked Members for their continuing interest in 
the United Kingdom Standardised Packaging of Tobacco Products Regulations 2015, notified in 
draft form under G/TBT/N/GBR/24. The EU informed  that the Standardised Packaging of Tobacco 
Products Regulations 2015 would come into force on 19 May 2016, the same day as the EU 
Tobacco Products Directive, and would apply to the whole of the UK.  
2.330.  As already noted in previous meetings, the EU reiterated that tobacco products had 
recognized harmful effects on human health. In this sense, Article 2.2 of the TBT Agreement 
included the protection of human health as a legitimate objective. It was recognized that any 
measure pursuant to this legitimate objective must not be more trade restrictive than necessary nor create unnecessary obstacles to international trade. It should also be noted that Article XX(b) 
of the GATT 1994 emphasizes the importance of pub lic health by justifying measures "necessary to 
protect human health". 
2.331.  The UK Standardised Packaging of Tobacco Products Regulations 2015 aimed at restricting 
the promotion of tobacco products to further redu ce the prevalence of smoking in the UK by: (i) 
discouraging uptake of tobacco use by young people; (ii) encouraging and supporting tobacco 
users who wanted to quit; and (iii) reshaping social norms and attitudes around tobacco use to promote health and wellbeing. 
2.332.  The measure formed the latest strand of a comprehensive range of tobacco control 
legislation already in place in the UK aimed at decreasing tobacco consumption. Under existing legislation, there was already a ban on advertising tobacco products to the general public, a ban of 
tobacco sponsorship to sports and cultural events, and companies were forbidden to give out free 
samples of tobacco. Picture warnings on tobacco products were required in the UK. The sale of tobacco products from vending machines and tobacco displays in all shops was prohibited.  
                                               
36G/TBT/M/65, paras. 2.171 and 2.136. G/TBT/M/68 
 
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  2.333.  In addition to the notified draft, the UK made available to the Members through the TBT 
notification an explanatory memorandum that detailed the rationale of the measure and its 
expected health impacts, an impact assessment and several scientific studies on the impact of 
plain packaging on smoking prevalence.  
2.334.  In parallel with the WTO notification, the UK  had also notified the measure to the European 
Commission in accordance with internal EU requirements for notification of draft national technical regulations under Article 8 (1) of Directive 98/34/EC. The UK had received detailed opinions from 
some EU member States on the draft measure with in the framework of the internal notification 
procedure. These had been analysed, considered an d replied to by the UK authorities. As regards 
comments received from WTO Members under the WTO TBT notification procedures, these had been equally examined and written replies provided. 
2.3  Exchange of information 
2.3.1  Thematic Sessions 2.335.  The Chairperson reported on the thematic sessions held on 8 March 2016. An advance 
copy of her report had been made available to Members in the room.37 She thanked the 17 
speakers who had shared their experiences in the areas of conformity assessment and good 
regulatory practice. 
2.336.  The representative of Australia said that his delegation would like to participate in the June 
thematic session on standards. Australia intended  to provide further information with regard to 
Australia's regulatory reform agenda which encouraged Australian regulators to use international standards wherever possible. While Australia would submit a formal proposal in writing, its 
participation was likely to focus on the process Australia had gone through to develop the 
regulatory reform agenda, and processes underta ken by regulators to determine the use of 
international standards. Specific topics could include the Australian standard-setting body and how 
it encouraged the use of international standards; the experience of the Australian regulators and 
policy makers in implementing policy; experiences from the context of business industry or consumers; and the benefits to these groups from the use of international standards by regulators. 
2.337.  The representative of Brazil asked for more  clarity on the structure and organization of the 
thematic sessions. 
2.338.  The Secretariat said that specific topics had been agreed in the context of the triennial 
review and these were set out in a work programme stretching to 2018.38 In June, one topic would 
be standards and another regulatory cooperatio n between Members; the latter would focus on 
energy efficiency.39  
2.339.  The representative of Canada said that th ere was a need to look at alternative formats for 
the thematic sessions that would engender a more meaningful engagement from Members. One 
possibility was panel discussions where technical experts could participate and answer questions 
from Members. 
2.340.  The US agreed with Canada. There had been too many presentations in too short a time, 
limiting the time for questions from the floor. It was important to give experts time to present and 
delegations time to discuss. For instance, on energy  efficiency standards, it would be important to 
bring in the right expertise to have a useful dialogue.  
2.341.  The representative of China said that they had proposed clarification on the rules for 
thematic sessions. How, for instance, could international organizations such as the ISO and IEC 
participate in the thematic sessions, and how about the private sector? 
                                               
37 This report was subsequently circulated as two separate reports and are co ntained in G/TBT/GEN/190 
(Thematic Session on Conformity Assessment) and G/ TBT/GEN/191 (Thematic Sessio n on Good Regulatory 
Practice). 
38 G/TBT/37, para. 8.3. 
39 More background was provided in a fax from the Ch airperson circulated subsequent to the meeting on 
17 March 2016. G/TBT/M/68 
 
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  2.342.  The representative of the United States said that the Committee had already clarified that 
observer organizations were welcome to participate in the thematic session; indeed, the 
representative of the OECD (an observer to the Committee) had made a presentation during the current week on the proposal from Mexico. And on the private sector, the US had proposed one 
particular speaker (for the thematic session on CAP) who had also spoken during the thematic 
session. What was needed was a better format for the discussions. 
2.343.  The representative of Chile agreed with the United States and Canada on the need for a 
better discussion on topics of interest. It would be  important to include experts from capital, but 
this also had resource implications; perhaps the Committee could look at financing speakers from developing countries.  
2.344.  The representative of Mexico said that th e thematic sessions had, in her delegation's view, 
been a very good experience. She supported the comments from the US, Canada and Chile. 
2.345.  The representative of the European Union stressed that the thematic sessions did not need 
to stick to a single model. The Committee had to be flexible, to adapt the format to the topic. 
There were topics like GRP where probably most presentations naturally came from Members 
because each delegation told a story about its own experience. For other topics there was actually a need to involve other types of actors from international organizations, maybe also from 
academia. What was needed – what all were lookin g for – was a good learning exercise. Perhaps, 
in view of the topics for the next thematic session, delegations could approach this with creativity; each delegation could make a proposal on th e format and who, in their view, should be 
intervening. If more time was needed, the Committee could consider extending the meeting. On 
the participation in the thematic sessions it was important not to stick to whether an organization 
had formal observership status or not. Expertise was essential. For the private sector, the practice so far had been for Members to involve private sect or as part of their delegation when this would 
bring added value.  
2.346.  The thematic sessions could also simply be an exchange of experiences where Members 
presented their own views on something – for in stance on a document the Committee wanted to 
develop. This is what had happened in the area of GRP: discussion had started from an exchange 
of experiences and this had turned into something else. It needed to be an open discussion; there was no one model. He suggested that the Committee reflect on what model could best fit the 
topics for the June sessions. 
2.347.  The Chairperson thanked delegations for their useful suggestions and said that she would 
consult with the incoming chairperson prior to the June sessions, as there was clearly a need to 
examine this issue further. 
2.348.  The representative of China said that his delegation had benefited a lot from the 
presentations both by the government representatives as well as representatives from the relevant 
international organizations, as well as the private sector – China was open to the participation of 
interested stakeholders as long as their expertise was relevant to the topic of the thematic session. 
2.3.2  GRP paper  2.349.  The Chairperson read out her report on the informal discussions on Good Regulatory 
Practices held on Monday, 7 March 2016. Her full report is contained in G/TBT/GEN/192.  
2.350.  The representative of Brazil stressed that some Members were of the view that a 
disclaimer would not at all be necessary; it was not necessarily the case that all Members had 
accepted, in principle, to have a "simple" discla imer. Brazil would continue to explore options on 
how to bring this work forward with the rest of the membership.  
3  TWENTY-FIRST ANNUAL REVIEW 3.1.  The Secretariat drew the Committee's attentio n to some proposed changes to the information 
contained in Annex A of the Review.40 The Committee also took note of document 
                                               
40 A revision to the original report was su bsequently circulated in G/TBT/38/Rev.1. G/TBT/M/68 
 
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  G/TBT/CS/2/Rev.22 containing a list of those standa rdizing bodies that have accepted the Code of 
Good Practice since 1 January 1995. 
4  TECHNICAL COOPERATION ACTIVITIES  4.1.  The representative of Paraguay thanked Mexi co and ALADI for the workshop on the Impact of 
Standards, Technical Regulations and Procedures for Conformity Assessment in international trade 
that had taken place in October 2015. This important activity which brought together representatives of public and private sector was pa rt of the project to build capacity of national 
technical committees within ALADI.  
4.2.  The representative of ISO emphasised the im portance of developing country participation in 
international standardization so as to ensure global relevance of international standards. The ISO 
Action Plan for Developing Countries had been published in January 2016 where the focus was on 
strengthening national quality infrastructure.41 
4.3.  The representative of the IEC updated the Co mmittee on recent activities relative to the TBT 
Committee. The full report is available on the IEC website.42  
4.4.  The Secretariat referred delegates to the te chnical assistance section of the Annual Review 
document G/TBT/38 for an overview of activities undertaken by the Secretariat over the past year. 
She explained that the participants of the March 2015 advanced TBT course were back in Geneva 
for a follow-up course to share experiences regard ing the implementation of action plans they had 
developed to address TBT-related challenges in their countries. She congratulated the participants for their commitment and very encouraging results. 
4.5.  The representative of the Kingdom of Bahrai n, one of the course participants, said that the 
course was a large step forward in terms of how technical assistance activities were run. All 
participants, with the help of their coaches, ha d been engaged in applying their action plans 
throughout the year. Strengthening the capacity of the course participants had had a multiplier 
effect. She was highly motivated after the March 2015 course to spread awareness on TBT matters 
and had done so through intensive courses for colleagues, lectures at schools and universities, and outreach to customs officials. She would continue  to share the knowledge and skills gained upon 
her return to Bahrain.  
5  UPDATING BY OBSERVERS 5.1.  The representative of ARSO made a comprehensive statement on TBT-related work.
43 
5.2.  The representative of the ACP said that the ACP Group had long recognized the enormous 
significance of non-tariff barriers, and TBT in particular. There was increased activity in TBT-
related issues in regional economic communities as well as organizations dealing with quality infrastructure. The presence of ARSO in the Committee was a testimony to this. As part of this 
increased attention and effort, the ACP Group in Geneva had benefitted greatly from technical 
assistance, most notably through an expert operating under the ACP EU TBT Programme.
44 The 
ACP Group hoped to contribute further to the work of the TBT Committee as well as in ACP 
countries' TBT-related work. He thanked the ACP EU TBT Programme for its most valuable 
assistance to projects in capitals, at the regional level and in Geneva. He hoped the important work of this programme would continue beyond the current term and assured the Committee that the ACP secretariat for its part would continue to contribute to the work of the Committee as TBT 
was a matter of great importance to the ACP Group. 
5.3.  The representatives of the IEC
44, UNECE, WHO, OIML and Codex45 updated the Committee on 
relevant work.  
                                               
41 http://www.iso.org/iso/iso_strategy_2016-2020_en_-_lr.pdf  
42 http://www.iec.ch/about/globalreach/partners/international/pdf_wto/iec_wto_2016_03_en_iec.pdf  
43 G/TBT/GEN/193. 
44 http://www.acp-eu-tbt.org/  
45 These statements were circulated in the documents G/TBT/GEN/194, G/TBT/GEN/195, 
G/TBT/GEN/196, G/TBT/GEN/197. G/TBT/M/68 
 
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  5.4.  The representative of Uganda noted that many of the outstanding requests for observership 
status had been pending for a number of years. He asked that the Committee make a decision on 
those long-standing applications by accepting those organizations that met the criteria and rejecting those that did not.  He welcomed the views of other Members on this matter. 
5.5.  The Secretariat explained that those organiza tions requesting observership needed to gather 
support among the Membership, as ARSO and IGAD had recently done, and then raise the issue in 
the Committee. Should any Member require historical information and background on the 
applications pending, he invited them to contact the Secretariat.  
6  ELECTION OF CHAIRPERSON  6.1.  The Chairperson informed the Committee that consultations were currently ongoing in the 
Committee on Trade in Goods. This agenda item was therefore suspended and would be reverted 
to at the next formal Committee meeting. 
7  DATE OF NEXT MEETING 7.1.  The next regular meeting of the Committee is scheduled for 15-16 June 2016. Two thematic 
sessions will be held on 14 June. 
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