RESTRICTED  
  
G/TBT/M/70  
 
 
17 February 2017  
(17-0977) Page: 1/77 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETI NG OF 10-11 NOVEMBER  2016  
CHAIRPERSON: MS ESTHER PEH  
Note by the Secretariat1 
1   ADOPTION OF THE AGEN DA ................................ ................................ ........................  1 
2   IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  ................................ . 1 
3   TECHNICAL COOPERATIO N ACTIVITIES  ................................ ................................ .... 66 
4   UPDATING BY OBSERVER S ................................ ................................ ........................  66 
5   REPORT (2016) OF THE  COMMITTEE ON TECHNIC AL BARRIERS TO TRADE  ...............  67 
6   DATE OF NEXT MEETING ................................ ................................ ............................  67 
ANNEX SUMMARY REPORT  OF EIGHTH SPECIAL ME ETING  ON PROCEDURES  FOR 
INFORMATION EXCHANGE  ................................ ................................ .............................  68 
1   ONLINE TOOLS  ................................ ................................ ................................ ..........  68 
2   FUNCTIONING OF ENQUI RY POINTS  ................................ ................................ .........  73 
3   TRANSPARENCY IN STAN DARD SETTING  ................................ ................................ .. 76 
 
1  ADOPTION OF THE AGEN DA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 6. 
2  IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  
2.1  Statements from Members under Article 15.2  
2.1.  The Chairperson  reminded the Committee of Members' notification obligation under 
Article  15.2 of the TBT Agreement and further informed the Committee that the latest list of 
statements on implementation submitted under this prov ision was contained in document 
G/TBT/GEN/1/Rev.15, issued  on 29 February 2016. She informed the Committee that since the 
last meeting in June 2016, Vanuatu, Burundi and Brunei Darussalam  had submitted statements . 
Japan had also submitted a revision to its  original statement. She further informed the Committee 
that since 1995, 135 Members had submitted at least one statement of implementation. 
Information on the list of statements is available at http://tbtims.wto.org .  
2.2  Specific Trade Concerns (STCs)  
2.2.1   Withdrawn concerns  
2.2.  The Chairperson  reported that the following STCs had been withdrawn from the agenda at 
the request of the concerned Member:  
                                                
1 This document has been prepared under the Secretariat's own responsibility  and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  G/TBT/M/70  
 
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  a. Peru — Draft Regulations implementing Legislative Decree No. 1222 on the optimiz ation 
of administrative procedures and strengthening of sanitary control over processed foods 
and fishery and aquaculture products  
2.2.2   New concerns  
2.2.2.1   Kazakhstan, Russian Federation — The amendments No. 2 to the Technical 
Regulation of the Customs Union on Safety  of Toys (TР МС 008/2011) G/TBT/N/KAZ/7 , 
G/TBT/N/RUS/73  (IMS ID 514)  
2.3.  The representative of Ukraine  expressed appreciation for the previous day's bilateral 
discussions with Kazakhstan , as a result of which certain agreements had been reached on  their 
notification . She nonetheless voiced concern that the conformity assessment procedure foreseen  in 
the Custo ms Union Technical Regulations "On safety of toys" (TR CU 008/2011) differed  
significantly from international practice  on declaration of conformity.  The re gulation indicated that 
stricter conformity assessment procedures were envisaged for all toys . Her delegation considered 
that Kazakhstan and the Russian Federation should justify such strict requirements for conformity 
assessment procedures with a  scientif ically substantiated clarification  and urged them to align with 
international practice and avoid causing  unnecessary technical barriers to trade.  
2.4.   The representative of the United States  expressed support for  the legitimate desire of the 
Eurasian Economic Commission  (EEC) to protect the em otional well -being of children and looked 
forward to discussions with EEC members to find a solution that did not unnecessarily restrict 
trade.  She flagged that her delegation would provide comments i f Armenia, Belarus, an d the 
Kyrgyz Republic intend ed to adopt this technical regulation . The US asked Russia and Kazakhstan 
to explain what criteria would  determine if toys were likely to result in the Article 4 risks to 
children, whether these criteria would be made public and  how long it would take to ma ke this 
determination.  Were domestic toys subject to the same evaluation? In addition, Russia was asked 
to clarify the age grading o f toys subject to this measure.  
2.5.  The representative of the European Union  thanked Russia for the ir bilateral meeting on the  
matter  and associated his delegation with the concerns of Ukraine and the US on the proposed 
requirement for the prevention of negative impact of toys on the developme nt and health of 
children. Whilst  fully support ing the object ive pursued by the Eurasian Economic Union (EAEU) of 
enhancing the safety of toys , the EU believe d that the requirement had  no scientific basis , bore no 
relation to toy safety, nor was there any global precedent on the matter. He formally registered his 
delegation's concerns and willingness to engage in future dialogue between the competent 
authorities of the EAEU , WTO Members and the toy industry . 
2.6.  The representative of Kazakhstan  emphasized that the questions regarding certification 
requirements and standa rds related to the provisions of Technical Regulation "On Safety of Toys" 
currently in force and which we re not being reviewed by the present draft amendm ents. The 
Technical Regulation "On Safety of Toys"  had been  adopted in September 2011 , entering into f orce 
on 1 July 2012.  To date , the competent authorities had  not received any information regarding 
problems in the applicati on of the technical regulation. She added that her delegation would be 
ready to answer all questions and comments upon receipt from Ukraine and other  interested 
parties in writing.  
2.7.  In response to questions from the US, she recalled that the draft amendments envisaged the 
establishment of requirements aimed at ensuring  the protection of children from possible negative 
impact on their d evelopment and mental health, preventing aggress ive behavior, fear and anxiety. 
Public consultation on the draft amendment had been announced o n 16 June 2016 with completion 
planned for 31 August 2016. Whilst t he draft amendments were under active  discuss ion, the public 
consultation had been  prolonged until 30  November 2016 , upon request of interested parties. She 
elaborated that t he rationale behind the amendments wa s that the domestic market had  been 
flooded by toys, predominantly dolls, inducing children  to aggressive behavior, instilling fear, and 
misconstruing the true anatomic al structure of the human body. Such toys, p sychologists warn ed, 
might  negatively affect children's mental health a nd development. Q ualified psychological and 
pedagogical expertis e of certain types of toys, taking  into account a possible psychological role in 
child development, had become  increasingly important in Kazakhstan . She clarified that a w orking 
group was in the process of discuss ing the types of toys to be subject to the expertise, as well as G/TBT/M/70  
 
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  the relevant criteria and methodology. Her delegation assured Members that all comments and 
constructive proposals could be sent either to its TBT Enquiry Point or to the EEC and would be 
taken into account as provided for by Article 2.9.4 of the TBT Agreement.  
2.8.  The representative of the Russian Federation  thank ed the EU and the US for their bilateral 
engagement on this issue. He expressed his delegation's support for the substance of the 
statement made by Kazakhstan and reiterated that  the period of public consultat ions on the draft 
amendments had  been extended until the end of November  2016. 
2.2.2.2   India — E-waste (Management) Rules, 2016  (IMS ID 515)  
2.9.  The representative of  the Republic of Korea  expressed concern that whilst E-waste rule 
(2016 ), rev ision of E -waste rule (2011), had been implemented from 1 October 2016, it had not 
been notified to WTO Members, preventing the submission  of comments at an appropriate stage, 
and causing Korean stakeholders to suffer from an insufficient period to a dapt to the regulation . In 
light of Article  2.9.2 of the TBT Agreement, his delegation therefore requested a 24 -month grace 
period for implementation . He further referred to the fact that the E -waste rule (2016) obliged 
manufacturers to collect 30% of e -waste as of  1 May 2017. However, waste electrical and 
electronic equipment  (WEEE) was frequently sold on the  Indian second -hand market. Moreover, 
95% of total e -waste in India was distributed via informal route s, according to a MAIT-GTZ report. 
Besides, it w as generally accepted that electrical and electronic equipment was used in India for 
more than 20 years according to the custom of using second -hand articles, while the average 
lifespan for electric equipment such as refrigerators and air -conditioners desc ribed in 
implementation guideline s was below ten years. All these factors made it difficult to accomplish the 
target collection rate of 2017 owing to the lack of WEEE collection. In regard  to Article 2.2 of the 
TBT Agreement which provides that Members sha ll avoid technical regulations creating 
unnecessary obstacles to trade , Korea suggested that India modify the estimation method for 
"expected e -waste generation" in consideration of the average lifespan of electrical and electronic 
equipment.  
2.10.   The represen tative of Japan  voiced support for the concerns raised by  Korea and urged 
India to provide a sufficient grace period and to review the target collection rate  based on actual 
market distribution and lifecycle  of electrical and electronic equipment in India.  
2.11.   The representative of United States  reported that US industry had  provided commen ts on 
several iterations of the regulation but that in the face of continued concern her delegation would 
shortly be  follow ing up with India.  
2.12.   The representative of India stated that the Ministry of Environment, Forest and Climate 
Change had issued the E -waste Management Rules, 2016 , in exercise of powers conferred by the 
Environment (Protection) Act, 1986. The rules laid down, inter alia , responsibilities of 
manufacturers, pro ducers, dealers, re -furbishers, bulk consumers, dismantlers, recyclers, etc. in 
the matter of e -waste management in India. For example, the rules asked a manufacturer in India 
to collect e -waste generated during the manufacture of any electrical and electr onic equipment 
and channel it for recycling or disposal. Likewise, bulk consumers were obliged to collect the items 
and hand them over to authorized recyclers. Various producers could have a separate Producer 
Responsibility Organisation (PRO) and ensure co llection of e -waste, as well as its disposal. Thus, 
the measure in question was primarily focused on collection and disposal of electronic waste in the 
country in an environmentally sound manner. In this light, India considered that the concern 
raised by t he delegation of Korea and supported by others did not seem to relate to any technical 
regulation, standard or conformity assessment procedures as defined under the TBT Agreement. 
India requested those delegations to reflect on whether the TBT committee wa s the appropriate 
forum for discussion. His delegation would nevertheless communicate the concerns raised to 
capital authorities for consideration.  
2.2.2.3   Ireland — Public Health (Alcohol) Bill 2015 G/TBT/N/IRL/2  (IMS ID 516)  
2.13.   The representative of Mexico  expresse d her delegation's concern with regard to the Public 
Health (Alcohol) Bill 2015, notified to Members in document G/TBT/N/IRL/2, the objective of which 
was "to reduce consumption to 9.1 litres of pure alcohol per capita and the harm caused 
by alcohol". Mexi co had submitted formal comments on this bill during the public consultation G/TBT/M/70  
 
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  process, based on the following considerations raised by domestic industry. Firstly the bill made  it 
illegal to sell or advertise alcohol products at a price below a set minimum p rice of 10  cents per 
gram of alcohol. Mexico considered that imposing a minimum price per gram on the sale of alcohol 
was in violation of  Article 2.2 of the TBT Agreement , since a less trade -restrictive measure could 
have been adopted to f ulfil the legitim ate objective. Moreover, there wa s no internationally 
recog nized justification which argued  that reducing the harmful consumption of alcohol could  be 
achieved by increasing market prices.  
2.14.   Secondly, the bill stated that l abels on alcohol products must cont ain warnings about the 
health risks of consuming alcohol, in particular during pregnancy . She added that the labels  must 
indicate the alcohol content per gram and give details of the Ministry of Public Health website, to 
be provided by Ireland's National H ealth Service, where information would  be available on the  
health  risks of alcohol consumption. Her delegation sought the scientific or technical justification 
for incorporating these items in the labelling of alcohol products, since Mexican industry argue d 
that the labels called for  by the Irish bill differ ed from the requirements commonly imposed on the 
entry of these goods into the EU, and as such could  be regarde d as unnecessarily restrictive.  
2.15.   Thirdly, she pointed out that the bill also provided  for al cohol to be displayed in separate 
areas in supermarkets and smaller outlets, to make it less visible to consumers in general. It was 
not clear whether there would be a limit on the space available for off -the-shelf sale or what the 
conditions would be in t he areas in which alcohol products would have to be displayed on the 
shelves of these points of sale, in accordance with the measure.  It was Mexico's view that the bill 
in this sense imposed  discriminatory treatment on the sale of alcohol products and sought to fulfil 
the legitimate objective pursued by means of a measure more trade -restrictive than necessary, 
again in  contravention of Article 2.2.  
2.16.   Mexico therefore requested an update on the present status of the bill , in particular  whether 
it had  already b een adopted and, if so, when it was expected to enter into force, and whether 
there was provision for a sufficient transition period to comply with the provisions of the law.   
2.17.   The representative of Guatemala , in expressing systemic concern about the measur e, in 
particular with harmonization, reiterated that his delegation recognized the legitimate objective  of 
protecting the health of the population but remained concerned about potential barriers the 
measure could establish.  
2.18.   The representative of the Europ ean Union  noted that i n parallel with t he WTO notification, 
Ireland had  also notified the measure to the European Commission in accordance with internal EU 
requirements for notification of draft national technical regulations under Article 5(1) of Directiv e 
(EU) 2015/1535.  Ireland had received comments from the Commission and detailed opin ions and 
comments from some EU m ember States on the draft measure within the framework of the 
internal notification procedure. These reactions  were currently being analyse d and considered by 
the Irish authorities.  As regards comments  that may be received under the WTO TBT notification 
procedure, he assured Members that these would  be equally examined and written replies 
provided in due course  by the EU . 
2.2.2.4   Bolivia — Technical regulations on the labelling of foods and products destined 
for human consumption that consist of, contain or derive from genetically modified 
organisms , G/TBT/N/BOL/3 , G/TBT/N/BOL/3/Add.2  (IMS ID 517)  
2.19.   The representative of Mexico  expressed support for Bol ivia's objectives of guaranteeing the 
right of users and consumers to information, for the pur pose of protecting human health, via 
provisions establishing a definition of Genetically Modified Organisms (GMOs) and providing for 
product labelling by means of  the use of words and symbols . Nevertheless, her delegation 
considered  that the measure could contravene Article 2.2 of the TBT Agreement , since it could 
prove to be more burdenso me than necessary to achieve this  legitimate objective . Moreover , 
further cla rification was requested with regard to the use of relevant international standards to 
support the technical content of the Bolivian measure, as domestic industry had  stated that it was 
not based on the Codex Alimentarius, since the latter did not suggest distinguishing food that 
contained  GMOs or using words or sy mbols to indicate such content. In this regard, n o 
internationally recognized scientific evidence existed to suggest that genetically modified food 
posed a risk to health. Mexican industry maintai ned that there was no difference between G/TBT/M/70  
 
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  genetically modified and conventional products with respect to their protein, nutritional, 
toxicological or allergenic composition, and as such should not receive different treatment.  
2.20.   Finally, with respect to the i mplementation of the regulations, Mexican industry noted  the 
technical and economic impracticability of establishing the system of segregation and traceability 
in the supply channels for basic agricultural products and in the subsequent stages of food 
manu facturing and marketing that would be necessary in order to comply with the proposed 
labelling. I ndustry  further pointed  out that complia nce with the provisions of the draft r egulations 
would require radical, expensive and unjustified restructuring of the supply and manufacturing 
systems. This would apply more particularly  to the supply chains and the basic agri-food industry, 
which would have an adverse effect on end consumer prices and ultimately on the basic food 
basket and a wide range of consumer produ cts.  
2.21.   Mexico therefore requested Bolivia: (i) t o consider eliminating the requirement  of a labelling 
scheme for foo d entering Bolivia that included  wording indicating the GMO content, in the absence 
of scientific basis for discriminating between convention al and genetically modified products ; (ii) to 
explain the grounds for this measure; and (iii) to arrange a video conference or meeting with the  
technical services responsible for drawing up the measure.  
2.22.   The representative of Guatemala  reiterated that his d elegation  recognized  the legitimate 
objective of protecting public health, but remained concern ed that these measures could  hinder 
trade. He express ed renewed concern over the lack of harmonization being generated across the 
region with regard to food labe lling as a result of the introduction of different measures in each 
country.  
2.23.   The representative of  the Plurinational State of  Bolivia  underlined that as an independent 
sovereign state his country  had the right to decide upon regulations according to  the ne eds of its 
population. Article 13 of the General L aw of  Consumer Rights stated that  reliable, comprehensive, 
relevant, easily accessible and timely product information  should be available to consumers. As 
such, the objective of the Bolivian standards was to guarantee those rights to consumers and 
therefore need ed no further scientific or technical justification . Bolivia maintained that there was 
no global precedent in the field of requirements for food for human consumption, whereby  labelling 
which indicate d GMO content  would be a technical barrier  to trade. To illustrate the point, he 
added that more than 60 Members currently used  different mechanisms to identify and label GMOs 
and their derivatives in order to safeguard public health . The thematic session on food labelling 
had highlighted that countries introducing such requirements were doing so with the objective of 
improving consumer information.   
2.24.   Regarding international standards he emphasized that Bolivia was a signatory to many 
international agreement s besides Codex, each with equal legal and constitutional value, in 
particular to the Cartagena Protocol on Biosafety,  Article 18.2 of which stated  that each party was 
to take measures to require the documentation and labelling of GMOs for human and animal  
consumption, for intentional introduction into the environment, and for contained use. To 
conclude, he stated that whilst Codex did not prescribe GMO labelling, neither did it deny the 
possibility of using it. Moreover, Codex document CAC/66/2011 recogniz ed the use of different 
approaches for labelling of foods derived from modern biotechnology.  
2.2.2.5   Korea — Amendment of the Notifications on Warning Messages on Smoking and 
Drinking , G/TBT/N/KOR/664  (IMS ID 518)  
2.25.   The representative of Mexico  expressed concern ra ised by domestic industry about two of 
the warning messages to be included in the labelling of alcoholic beverages, which point ed to a 
causal relationship between alcohol consumption and cancer by stating that: "alcohol is 
carcinogenic, so that excessive d rinking causes cancer of the liver and the stomach" and 
"excessive drinking is the cause of cancer". Mexican industry maintained  that there was no 
scientific evidence establishing  such a causal link , since epidemiological studies pointed to a wide 
range of  cancer risk  factors , including family history, genetics, lifestyle and environmental factors. 
Moreover, existin g scientific literature (studies carried out by the US Centers for Disease Control 
and Prevention in 2011 and the National Institute for Alcohol  Abuse and Alcoholism in 2013 ) 
stressed  that moderate consumption of  alcohol was also regarded as an important part of a 
healthy lifestyle. Accordingly, Mexico  considered that the messages required by the Korean G/TBT/M/70  
 
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  measure constitute d an unnecessarily burdens ome mechanism for ensuring the fulfilment of the 
legitimate objective of the measure, i.e. the protection of human health, in breach of Article 2.2, 
and that moreover they might not provide clea r information for the consumer. Her delegation also 
believed t hat the measure did not afford a sufficiently long  comment period during the 
international public consultation stemming from notification G/TBT/N/KOR/664, or an adequate 
transition period for the regulated sector to comply with the new labelling provisions , based on the 
provisions of Article 2.9 of the TBT Agreement . 
2.26.   Mexico therefore requested  Korea: (i) to take into account existing scientific literature with 
respect to the correlation between alcohol consumption and cancer and to consider el iminating or 
amending the above -mentioned warnings to avoid conveying unclear message s to consumer s; 
(ii) to hold a video conference with the Korean authorities responsible for the measure, in order to 
clarify the nature of the scientific and technical information consi dered in connection with its 
implementation and to examine industry's arguments concerning existing scientific literature; and 
(iii) to further extend the period for comments on the measure and to grant an additional period 
for its entry into force, accord ing to relevant Committee recommendations . 
2.27.    The representative of the United States  voiced support for Korea' s efforts to protect public 
health by informing consumers of the risks of excessive alcohol consumption.  Although Korea had 
notified the regulation  to the WTO, the US wa s troubled that Korea had finalized and adopted it 
prior to the end of the comment period.  She asked how Korea would take into account comments 
received from M embers and stakeholders after 31 August 2016 but before the end of the 
28 September 2016 comment period. A delay was requested in the adoption and implementation 
of the warning label requirements to allow  for significant dialogue with M embers which had not 
been provided under the norms of the C ommittee.  She asked w hen Korea would respond to their 
comments and those of US industry. If the regulation was already finalized, how would  Korea 
respond?  The US was disappointed that Korea had not allow ed for sufficient stakeholder input on a 
measure which would  increase costs and resources  for US  exporters to such a close trading 
partner.  Her delegation looked  forwa rd to further engagement with Korea on the  measure and, in 
the future, sufficient opportunities for input on regulations which would impact their trade.  
2.28.    The representative of New Zealand  expressed support for Korea's right to introduce new 
regulations to address specific public health concerns, specifically the harmful use of alcohol, in 
order to fulfil the legitimate public health objective in the notification a nd appreciated th at, in 
seeking to  address the harmful use of alcohol, the notification was directed towards achieving a 
legitimate public health objective. Her delegation looked forward to a prompt response to written 
comments submitted on 6 October 2016. She asked whethe r Korea had considered less trade -
restrictive alternatives when drafting this regulation, in accordance with the principles of the TBT 
Agreement and if so, what these alternatives were and the reasons for not selecting them. An 
official English translation  of the regulation was also requested, to ensure that Members could be 
certain as to the intent of the language in the regulation.  
2.29.    The representative of Australia  recognized Korea's right to take measures to protect 
consumer health and that health warning  labels for alcoholic beverages could address a legitimate 
public health concern. Her delegation, nevertheless, sought further information from Korea about a 
number of aspects to the changes to the National Health Promotion Act related to alcohol and wine 
labelling. She requested that Korea provide an official English translation of the proposed health 
warning statements, in view of the number of different translations available. Some available 
translations, she added, seemed to establish a direct link betw een alcohol consumption and certain 
diseases. Australia asked if this was the intent of the proposed warning statement and suggested 
that the label be drafted in a way that would reflect scientific consensus on the issue . Her 
delegation additionally reques ted confirmation that the regulation did not require a rotation in the 
use of the three health warnings and whether producers could choose between the three labels.  
She further asked Korea to confirm if the regulation had entered into force on 3 September 2016. 
Finally, Australia requested deferral of implementation  of the measure  in order to allow for a 
proper consultation period in accordance with Korea's obligations under the TBT Agreement as well 
as an extension of the post -consultation transition perio d to allow sufficient time for business to 
adjust.  
2.30.   The representative of Canada , whilst recognizing Korea's efforts to minimize the negative 
health impacts associated with excessive  alcohol consumption, echoed the concerns raised by G/TBT/M/70  
 
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  other Members, in part icular the fact that the measure came  into force before the end of the 
comment period and without providing an adequate time for exporter to adapt.  
2.31.    The representative of Japan  noted that it had submitted comments on the notification, 
requesting that appr opriate measures be taken, including the provision of a sufficient transition 
period  to avoid creating  unnecessary obstacles to foreign liquor exporters.   
2.32.    The representative of the Republic of Korea  recalled that it had received  comments from 
Member s on t he notification, and on consideration thereof had granted a grace period of 12 
months, as specified in Article 4 of the Regulations of the National Health Promotion Act.  With 
regard to specific points such as the scientific basis for the  regulation  and the  English translation of 
warning messages, his delegation was ready to consult bilaterally with concern ed parties.  He 
concluded by recalling Korea's conviction that controlling health hazards stemming from the 
excessive consumption of alcohol was a matter o f utmost  importance in his government' s duty to 
protect the health of the population  and therefore sought Members' understanding and support for 
the new regulation . 
2.2.2.6   Uganda — Alcoholic beverages specifications , G/TBT/N/UGA/434;  
G/TBT/N/UGA/435, G/TBT/N/UGA/ 437, G/TBT/N/UGA/438 , G/TBT/N/UGA/439, 
G/TBT/N/UGA/440 , G/TBT/N/UGA/441  (IMS ID 519)  
2.33.   The representative of the European Union  thanked Uganda for the replies it had provided to 
their comments on the notified drafts. His delegation nevertheless wished to hig hlight some 
unresolved issues. Firstly, the drafts required the date of manufacture to be indicated on some of 
the products. In this regard, he reiterated that Codex Standard, Labelling of Prepackaged Foods 
(CODEX STAN 1 -1985) did not require such a compul sory labelling indication. In addition, the EU 
considered that for alcoholic beverages the date of manufacture would have no added value since 
they were not perishable products and this could therefore mislead the consumer. Secondly, 
according to the notif ied drafts, imported products would have to indicate the name and address of 
the manufacturer. The EU noted that Codex Standard, Labelling of Prepackaged Foods (CODEX 
STAN 1 -1985) recommended indicating the name and address of the importer as a contact poi nt 
for consumers for any product -related question or issue and considered the approach of 
consumers contacting a person in the marketing country and in their own language easier than in 
the country of export.  
2.34.   Thirdly, his delegation requested clarification  of the meaning of some of the analytical 
requirements set out in some of the notified drafts such as, for example, those for total solids, 
volatile acids such as acetic acids, higher alcohols and furfural. He further asked for information on 
the rationale  of the need to fix such limits and on what basis those parameters had been fixed. 
Lastly, he reiterated that Codex Standard, Labelling of Prepackaged Foods (CODEX STAN 1 -1985) 
did not provide for the compulsory labelling of indications like "blending" for  blended products and 
"white rum" for rum that is not aged. The indication "blended" was required exclusively for some 
high quality products (e.g. some geographical indications) but not for basic whisky or wine spirits. 
On the basis of the above -mentioned issues, the EU recalled the provisions of Article 2.4 of the 
TBT Agreement on the use of relevant existing international standards. In summing up, the EU 
requested an update on the revision process of these technical standards. It was his delegation's 
understanding that the next meeting of the responsible technical committee of the East African 
Community would take place from 28 November to 2 December 2016; Uganda was therefore 
invited to ensure that the issues raised in the Committee would be transmitted t o this technical 
committee and be taken into account in the revision process.  
2.35.   The representative of the United States  voiced support for the EU's comments which 
resembled their own concerns to be raised on the STC 412 relating to Kenya  — East African 
Commu nity (EAC) alcoholic beverage standards . She urged Tanzania and Burundi to provide 
notifica tions if  they planned adopting similar measures.  
2.36.   The representative of Uganda  noted that comments received from the EU and other 
Members on these alcoholic beverage s standards had been answered. As the standards were, 
however, slated for review, he assured the EU that any remaining concerns would be considered at 
that time.  
                                                
2 See paras. 2.299.   - 2.301.   page 59. G/TBT/M/70  
 
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  2.2.2.7   Russian Federation — Medical devices , G/TBT/N/RUS/51, G/TBT/N/RUS/52, 
G/TBT/N/RUS/53, G/TBT/N/ RUS/55  (IMS ID 520)  
2.37.   The representative of the European Union  noted that, while the four drafts had been notified 
on 10 and 11 May 2016, the proposed date of adoption was 5 July 2016 and final date for 
comments was 5 June 2016. He asked why the normal comme nt period for notifications of at least 
60 days had not  been provided. In relation to G/TBT/N/RUS/51, the EU considered that the draft 
established an unduly long timeline for the review of dossiers presented in the framework of 
technical testing for medica l devices as part of their "expert evaluation", and believed that this 
would prevent the market from adequately keeping up with the pace of innovation. He questioned 
why the Russian authorities considered such a long review time as satisfactory  and necessa ry, 
pointing out that the timeline for expert evaluations in the EU was normally between 30 and 60 
days, compared with what seemed to be over 300 days in the notified draft. Concerning 
G/TBT/N/RUS/52, the EU noted the proposed date of adoption of the notif ied draft rules of 5 July 
and the proposed date of entry into force of 1 January 2017 and recalled that adequate transition 
times, in particular for registration procedures, were necessary to avoid disruption of market 
access. He stated that generally a tr ansition period of three  to five years was provided for such 
measures, ensuring a viable transition for the medical device sector, both because of the technical 
complexity involved in regulating the sector and the large number of medical devices involved. 
Furthermore, the use and recognition of international standards (especially those of ISO) and best 
practices (notably for the recognition of clinical information) were essential to ensure market 
access for medical technologies around the world and in this regard he recalled obligations under 
Article 2.4 of the TBT Agreement. The EU therefore urged Russia to consider a longer transition 
period as well as the use and recognition of international standards and best practices.  
2.38.   On G/TBT/N/RUS/53, the EU understo od that all relevant information regarding " safety and 
efficiency " of a medical device had to appear on its label and sought clarification regarding the 
scope of "labelling" information and "operational documentation" information . Finally, turning to 
G/TBT /N/RUS/55, the EU recognized  that, in addition to EAEU  registration procedures for medical 
devices, "recognition by expert reports" was required for each individual EAEU  member. The EU 
requested clarification as to whether such decisions of the Board of th e EAEU  regarding medical 
devices registered under the new rules could be fully and directly appli cable (and enforceable) in 
all members of the EAEU  without such additional "recognition by expert reports".  
2.39.   The representative of the United States  supported the comments made by the EU and said 
her delegation would follow up in writing directly with the Russian Federation.  
2.40.   The representative of t he Russian Federation  recalled that the Agreement on Common 
Principles and Rules of Medical Devices Circulation in t he EAEU  had been signed in December 
2014, for the implementation of which  a package of documents had been  developed. To date, all of 
these documents had been adopted by the EEC but would only  enter into force once all EAEU 
Members had ratified the Agreemen t. He reassured Members that overall the entry into force of 
this package of documents would not imply  dramatic changes in requirements or conformity 
assessment procedures, as the transitional period would last until 31 December 2021. In 
particular, previo usly issued certificates of registration of medical devices would  be valid during the 
transitional period.  
2.2.2.8   Russian Federation — Pharmaceutical products - Resolution 1314 of the 
Government of the Russian Federation on determining compliance of medicinal pro ducts' 
manufacturers with the requirements of Good Manuf acturing Practice (non -notified ); 
draft decisions of the Board of the Eurasian Economic Union  
G/TBT/N/RUS/54,/TBT/N/RUS/58, G/TBT/N/RUS/63  (IMS ID 521)  
2.41.   The representative of the European Union  raised concern regarding measures adopted by 
the Russian Federation introducing certification requirements for medicinal products, for both 
human and animal use.  Of most significant concern  to his delegation was  Resolution 1314 of the 
Government of the Russian Fe deration on determining compliance of medicinal products' 
manufacturers with the requirements of Goo d Manufacturing Practice (GMP), dated 3 December 
2015. He expressed concern that this resolution had apparently not been notified to the WTO  as it 
introduce d a requirement of inspection and certification of production sit es of medicines with 
regard to GMP , including foreign manufacturing sites, a pre -condition for obtaining  a marketing 
authorization in the Russian Federation. As the r esolution therefore had  a significant effect on G/TBT/M/70  
 
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  trade, his delegation considered that it should be subject to the obligation laid down in the TBT 
Agreement to notify draft measures for review by WTO Members. R egard ing entry into force, the 
EU was of the understanding that the meas ure, adopted on 3  December 2015, had started to 
apply to foreign manufact uring sites since 1  January 2016 w ith two concrete consequences: the 
GMP certifica tion requirement already applied to new  products without a pre viously accepted 
market authorization; and the renewal of marketing authoriz ation would  require GMP certificates 
as of 1 January 2017.  
2.42.   The EU considered that the interval of one month between the adoption of the measure and 
its entry into force fell short of the obligation under the TBT Agreem ent to provide  sufficient time 
to allow  manufacturers to adapt to new requirements . Moreover, it appeared that the measure 
foresaw  a timeline  for the examination of foreign manufacturing sites of up to 160 business days, 
much longer than the transition per iod. In addition, the number of foreign manufacturing sites 
supplying medicines to the Russian Federati on wa s very high. For each site manufacturing a new 
imported product without a curr ently existing marketing authoriz ation, or whenever curre ntly 
accepted  marketing authoriz ations expire d, an inspect ion by the Russian authorities wa s necessary 
as a condition for the requisite  GMP certification. Therefore, to ensure smooth and least -trade -
disruptive entry into force of the measure , substantial resources woul d need to be allo cated by the 
Russian Federation. It was his delegation's understanding,  however, that the inspection capacity 
made available by the Russian Federation would be far from the level required for such a smooth 
entry into force, especially when  the measure had  already been in force for almost one year.  
Moreover, for veterinary products, it a ppeared  that not only sites manufacturing final products 
need to be inspected , but also those manufacturing Active Pharmaceutical I ngredients (APIs), 
which would increase  the burden for industry and the requirements in terms of inspection capacity 
for the Russian Federation.  
2.43.   He reiterated that t he lack of notification and therefo re of transparency towards WTO 
Members, the absence of an appropriate transition p eriod a nd the mismatch between requisite  
inspection capacity and the resources allo cated by the Russian Government, result ed in a very 
difficult situation for industry which particularly affected foreign sites, due to the additional 
difficulties of the ins pection process abroad. This situation wa s already restricting imports of 
medicines into the Russian Federation and, unless additional mea sures we re taken, his delegation 
believed that the negative impact could become much more severe once currently accept ed 
marketing authorizations expire d. The EU t herefore  requested that (i) the measure be notified to 
the WTO, to allow for review by M embers with a view t o taking  into consideratio n their comments 
for the finaliz ation of the measure ; (ii) appropriate transi tion time and additional accompanying 
measures be taken , including in the area of organiz ation of inspections, so as to ensure that the 
GMP certification requirement could  be complied with by foreign manufacturers  in a timely fashion 
with no  negative impac t on their exports to the Russian Federation ; and (iii) the specific issue for 
veterinary products of double inspection of sites manufacturing APIs and final products be 
reconsidered by the Russian Federation . 
2.44.   He ended by expressing his delegation's hope t hat the development, adoption and entry into 
application of the measures contained in notifications G/TBT/N/RUS/ 54, 58 and 63 would be fully 
compliant with the obligations laid down in the TBT Agreement, in particular with regard to the 
need to provide suf ficient delay between the adoption of the measure and its entry into application 
so that manufacturers could  adapt to the requirements of the measure.  
2.45.   The representative of the United States  acknowledge d that Russia  had circulated the " Draft 
Agreement on C ommon Principles and Rules of Medicinal Products Circulation in the Eurasian 
Economic Union (E AEU)"  and its implementing acts to WTO Members in May 2016, providing  
stakeholders with less than a 60 -day comment period.  Regarding the implementing act  dealing 
with GMP requirements, her delegation  supported Russia' s objective to ensure that human and 
veterinary medicines on the ir domestic market were safe and effective, but had been informed by 
industry that the implementing acts might  result in trade disruption s, for example in the case of 
insufficient officials in Russia to conduct GMP inspecti ons of all the proposed sites.  A status report 
of such inspections was requested. Further, i ndustry and local stakeholders in Russia had report ed 
that they we re concer ned that the GMP requirement had  caused significant delays in the 
registration of new medicines. On the agricultural side, this requirement could lead to a shortage 
of veterinary medicines for livestock , which could in turn negatively impact Russia's goal  of 
increasing its food production. The US urged Russia to provide a transition period  so that Russian 
citizens would not lose access to innovative lifesaving medicines and so that Russian livestock and G/TBT/M/70  
 
- 10 - 
 
  pets would not be  exposed to the risk of infectious disea ses. Confirmation was also sought that 
Russia would  no longer require that clinical trials for orphan drugs be conducted in Russia. The US 
encourage d Russia to discuss potential solutions to this issue with stakeholders such as patients, 
hospitals, and ind ustry, and assured that US  industry stakeholders stood  ready to help facilitate 
these discussions . 
2.46.   The representative of the Russian Federation  stated that Federal Law No. 429 -FZ of 
22 December 2014 amended Federal Law No. 61 -FZ of 12 April 2010 "O n the Ci rculation of 
Medicines" by  introduc ing a compulsory requirement whereby  the manufacture  of pharmaceutical 
products should comply with GMP provisions in order to adequately protect human life, health and 
safety. Resolution No. 1314 of the Government of the Russian Federation o f 3 December  2015 
approved the r ules of inspections  for manufacturers of pharmaceutical products in order to 
implement Federal Law No. 61 -FZ. This resolution set  out the fee for this service, and wa s equal 
for domestic and foreign manuf acture rs. The r ules of said inspections did  not contain provisions 
discriminating against foreign operators.  Moreover, t he schedule of inspe ctions of foreign 
manufacture rs was publically available on the official website of the Ministry of Industry and Tra de 
of the Russian Federation , listing  almost one hundred inspections in the second half of 2016. 
Accor ding to the r esolution, the Ministry of Industry and Trade (in respect of pharmaceutical 
products for human s) and the Federal Service for Veterinary and P hytosanitary Supervision 
("Rosselkhoznadzor") (in respect of pharmaceutical products for a nimals) we re authorized to 
control and monitor the application of the GMP conformity certification system  to pharmaceutical 
products. The quantity and frequency of in spections depend ed on the number of requests thereof . 
He reported that work on the Draft decisions of The Board of the Eurasian Economic Union  was still 
on-going  and that their adoption w ould require changes in legislation of the EAEU members. He 
neverthel ess guaranteed that previously issued certificates would  remain  valid for a certain 
transitional period.  
2.2.2.9   Mexico — Official Standard PROY -NOM -199-SCFI -2015: Alcoholic beverages - 
Designations, physicochemical specifications, commercial information and test  methods  
G/TBT/N/MEX/302  (IMS ID 522)  
2.47.   The representative of the European Union  asked Mexico how the comments the EU had 
submitted on 29  April 2016 relating to the notification were being taken into account. The concerns 
on Mexico's  draft technical regulati on raised in these comments relate d to the definition of several 
products, to some analytical parameters, to the definition of ethyl alcohol and to the existing 
maximum alcoholic strength for spirit drinks. In particular, the EU requested Mexico to align i ts 
technical regulation to the Recommendations of the International Organisation of Vine and Wine 
(OIV), including the International Code of Oenological Practices, as well as  to widely accepted 
international practices , in view of the provisions containe d in Article 2.4 of the TBT Agreement . 
She recall ed the TBT Committee Decision on the Timing of Entry into  Force of Technical 
Regulations  which determined that a "reasonable interval" should  normally constitute a period of 
not less than six months, except whe n ineffective in fulfilling the legitimate objectives pursued and 
urged Mexico to respect a minimum period of six months between entry into force and 
implementation of the measure . Lastly, she request ed an update on the state of play in the 
process of modi fication of this technical regulation.  
2.48.   The representative of Mexico  reported that t he final version of the draft regulation had  not 
yet been published in the Mexican Official Journal, since the Working Par ty responsible for drafting 
it wa s still evaluating  the comments received during the public consultation  period . The last 
meeting of the Working Party had been  held a month previously , at which point most of the 
comments received from the various interested parties had been incorporated. She nonetheless 
assured Members that the health and labelling conditions established i n Mexican Official Standard 
NOM-142-SSA1/SCFI -2014, "Alcoholic beverages. Health specifications. Health and commercial 
labelling" would  remain in force , supplement ing the content of Mexica n Official Standard NOM 199. 
Lastly she stated that whilst there wa s no estimated date for the publication of the final version of 
NOM 199, it was expected to take place in the first quarter of 2017.  
2.2.2.10   European Union – Country of Origin Labelling (IMS ID 52 3) 
2.49.   The representative of the United States  stated that a number of EU member States (France, 
Finland, Greece, Italy, Lithuania, Portugal, and Romania) were in the process of developing, and in 
some cases implementing, country of origin labelling  (COOL) sch emes for milk and meat, and G/TBT/M/70  
 
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  certain processed food products containing dairy or meat ingredients. She outlined that each 
member State's requirements and product coverage varied but that in general the measures 
appeared to require the labelling of pre -packa ged food products containing meat and dairy with 
the origin of each meat and dairy ingredient.  It appeared that in some cases, information on origin 
relating to place of birth, fattening, slaughter, milking, processing or packaging was required.  In 
some in stances, if all activities occurred within the EU, member States could permit a label stating 
"Origin: EU"; conversely, for activities occurring outside of the EU, the label could read "Origin: 
Outside EU". It also appeared that in some cases the measures also applied to certain primary 
products, for example, requiring the labelling of origin of fluid milk. She reported that US industry 
had raised serious concerns that the new country of origin labelling requirements in various EU 
member States could act as  a non -tariff barrier to trade. Her delegation encouraged the EU to 
notify the measures shortly as in the absence of notification by the Commission or the member 
States, US industry had been unable to obtain authoritative versions of the regulations, and n ot 
granted the opportunity to comment on them.   
2.50.   Furthermore, it would seem EU member States would not ha ve time to consider any 
comments. She recalled recent WTO findings on related issues in which the US was a party which 
her delegation believed should gi ve EU member States a significant  time period b efore finalizing 
these proposed measures.  In this regard, she suggested that soliciting and taking into account the 
feedback of trading partners and affected stakeholders would be prudent. Moreover, it appeare d 
that some of the member State measures were expected to enter into force on 1 January 2017, 
which would not allow for notice and comment or a reasonable interval between publication and 
entry into force. The US requested clarification on the proposed tim eline for moving forward with 
the COOL measures and questioned whether the EU and the member States were allowing a 
"reasonable interval" between publication and entry into force.   
2.51.   More generally, she noted that the member State labelling requirements rais ed a number of 
concerns because of differing treatment between EU versus non -EU origin products, as well as the 
potential amount of recordkeeping required to comply with the proposed measures.  Furthermore, 
she noted that some of the measures included a mut ual recognition clause which appeared to 
favour select countries by exempting processed foods originating in those countries from the 
requirements, and that the measures could create incentives for local food processers to use 
locally produced dairy and me at ingredients to the detriment of US exports.  She concluded by 
expressing her delegation's willingness to discuss these issues in detail with member States. Given 
the importance of these affected sectors in the US, the Commission was urged to intervene to  
ensure consistency with the relevant WTO obligations so that these regulations would not present 
barriers to US -EU trade.  
2.52.   The representative of New Zealand  voiced support for the concerns raised by the US, in 
particular in seeking a time -frame for notifi cation of the draft proposal as well as an update on the 
forward process.  
2.53.   The representative of the European Union , whilst recalling that this was the first instance of 
member State measures requiring country of origin labelling for food products being rai sed in the 
Committee, referred to the applicable EU regulatory framework as regards the adoption of member 
States' national measures in this field. Regulation (EU) 1169/2011 on the provision of Food 
Information to Consumers allowed member States to introdu ce measures concerning the 
mandatory indication of the country of origin or place of provenance for certain category of foods, 
following the specific notification procedure established for this purpose in the Regulation. 
Accordingly, member States who deem ed it necessary to adopt such national measures had to 
notify them to the Commission and the other member States, providing justification for them 
based on grounds specified in the Regulation, including consumer protection. In addition, member 
States neede d to provide evidence supporting their measures, for instance, that the majority of 
consumers in the member State concerned attached significant value to the provision of the origin 
indication. He pointed out that certain member States had recently notifie d draft national 
measures according to this procedure, some of which were currently under assessment by the 
Commission. His delegation remained available for further bilateral discussion.  G/TBT/M/70  
 
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  2.2.3   Previously raised concerns  
2.2.3.1   European Communities – Regulation on the Registration, Evaluation and 
Authorization of Chemicals (REACH)  (IMS ID 88)  
2.54.   The representative of Canada  reiterated  concern s about the significant negative impact of 
various aspects of REACH on small and medium -sized enterprises ( SMEs ), including the "Only  
Representative" (OR) and "Letter of Access" (LoA) p rovisions, and the  2018 registration deadline 
for substances manufactured or imported in quantities from 1 to 100 tonnes .  
2.55.   Canadian SMEs have expressed concerns about the exceedingly high cost for substan ce LoA 
relative to their volume of business. In one instance, the LoA cost to register eight substances 
exceeded EUR 200,000 for an enterprise doing CAD$2.5 million in annual business, and these 
costs could exceed EUR 500,000 for the remaining substances t hey would be required to register 
under REACH. He was  particularly concern ed that the requirement to register would not exist if 
substances were purchased in the EU, exported to Canada, and then re -imported to the EU in 
value -added products.  
2.56.   While Canada u nderst ood that EU manufacturers ha d already incurred registration 
compliance costs, he asked  the EU to explain why Substance Information Exchange Forums 
(SIEFs) were permitted to use the LoA  process to effectively freeze out non -EU SMEs or late 
entrants fr om the EU market. Canada recognized that the European Chemicals Agency did not own 
the data produced for the registration dossiers, however, it appeared that in practice a certain 
number of lead registrants and OR consultants were using the LoA and OR proc esses for economic 
advantage. Canada strongly urged  the EU to ensure that SIEFs were not permitted to use the LoA 
process to obt ain unfair economic advantages. Canada believe d that it was not just Canadian 
SMEs, but SMEs within Europe that were being negat ively affected by these prohibitive registration 
costs.  
2.57.   Canada requested that the  EU explain the process for appealing excessive LoA fees under 
REACH. He reported that Canadian SMEs had approached REACH helpdesks and would appeal LoA 
fees in due course. H owever, Canada was of the  view the EU should  do more to ensure that SMEs 
and late entrants to the EU market were not unduly affected by these administrative anti -
competitive practices , which in the view of Canada were not contributing to the health, safety  or 
environmental protection  objectives of the regulation . 
2.58.   Canada suggested that the EU consider extending the number of low -risk substances 
exempt from registration under Annex V of REACH, including substances for which the psycho -
chemical properties were  extremely well -known and traded in high volumes, such as citric acid and 
soda ash . Canada asked the EU what the process would be to nominate such substances.  
2.59.   Finally, Canada was encouraged that the  EU had initiated a " fitnes s check"  of REACH , which 
includ ed a review of support measures for SMEs, registration requirements for low tonnage 
substances, and the effect of the regulation on competitiveness of SMEs . Canada hope d the EU 
"fitness check " would  focus on burden reduction and simplification to address t he disproportionate 
costs to SMEs.  
2.60.   The representative of the European Union  reaffirmed his delegation's statements in past  TBT 
Committee meetings , and  bilateral meeting s with Canada , namely that the EU was taking 
measures to ensure that SMEs were not detrimentally affected by REACH requirements . An 
evaluation of REACH was ongoing, and  a public consultation  was open.  
2.2.3.2   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40, G/TBT/N/IND/40/Rev.1 (IMS ID 1 33)  
2.61.   The representative of the European Union  reiterated his delegation's concerns with the 
Indian measure at issue which introduced a certification procedure with a mandatory marking for 
tyres. The EU referred back to its previous statement at recent Comm ittee meetings concerning 
the ISI marking fee and the US$10,000 bank guarantee . India was requested to align its 
procedures to international practices and remove the obligation to pay a marking fee per marked 
tyre and to eliminate the discriminatory bank g uarantee requirement.  The EU had asked India to G/TBT/M/70  
 
- 13 - 
 
  provide information about the new Schedule of Testing Inspections (STI) 15633/5 of November 
2015. The new measure introduced the concept of "control unit", meaning 5,000 tyres of the same 
family.  It required testing of every tenth control unit for load and speed performance, endurance 
test, bead unseating resistance test and tyre strength test. During the recent bilateral meeting, 
the EU understood that the control unit was modified to 30,000 types of the same  family and his 
delegation asked for confirmation of this modification. The EU considered that these testing 
requirements were extremely burdensome and costly and asked what specific safety -related 
objectives India was pursuing.  During the last meeting of the Committee, India had said that the 
new measure might be further amended following the comments received;  the EU asked for an 
update on state of play in this regard and asked India to notify the measure.   
2.62.   The representative of Japan  voiced support for t he position of the EU regarding this issue. 
Regarding the increase in Conformity of Production (COP) test frequency, Japan expressed its 
appreciation with the improvement by the revised draft which came into force in July 2016. Japan 
expressed continued co ncern in regards of other points.  Japan considered that there were 
misunderstandings on the facts (e.g. the basis for calculation of marking fee) between her 
delegation and India. Consequently, Japan looked forward to bilateral meetings to reach mutually 
satisfactory solutions.  
2.63.   The representative of India said that concerns relating to the bank guarantee requirements 
were not new and had been responded to several times at previous meetings of the Committee. 
This was similarly the case for the marking fee. Therefore, the interested delegations were 
requested to refer to the statement made by India on these matters at previous meetings, 
particularly in the minutes of the meeting held in March 2015.3 Regarding the Scheme for Testing 
and Inspection as per STI/1 5633/ 5 Nov ember  2015, India refered to its statement of the meeting 
held in March 2016, in which it indicated that the matter was under further consideration of the 
authorities. Based on the feedback received, the STI for Pneumatic Tyres for passenger car  
vehicles had been revised as STI/15633/6 March 2016, which would enter into force in 20 July 
2016. In the earlier STI of November 2015, one control unit was defined as 5,000 tyres. However, 
in this revised STI one control unit had been defined as 30,000 ty res. In both of these STIs, a test 
had to be carried out on one sample of a family of tyres for every 10 control units. This test would 
be required to be carried out once for every 300,000 tyres, and not every 50,000 tyres since the 
control unit in the lat est STI was 30,000 tyres instead of 5,000 tyres. Consequently, the testing 
frequency was reduced six times .  
2.64.   Regarding the notification of the new STI, he said that Members were required to notify 
conformity assessment procedures that are not in accordance  with the relevant guides and 
recommendations issued by international standardizing bodies, as per Article 5.6 of the TBT 
Agreement. He indicated that the Bureau of Indian Standards ( BIS) Product Certification Scheme 
was based on the international standard  ISO/IEC 17067 (Type 4). He noted that acceptance and 
maintenance of the ST I was a condition for BIS licenc e and that it was applied without 
discrimination to domestic and foreign manufacturers.  
2.2.3.3   China - Provisions for the Administration of Cosmetics Appli cation Acceptance, 
G/TBT/N/CHN/82 1, G/TBT/N/CHN/937 (IMS ID 296)   
2.65.   The representative of Japan  reiterated its concerns regarding the "Guidance for Application 
and Evaluation of New Cosmetic Ingredients" in terms of speed of examination, safety evaluation 
requirements and information disclosure. Japan asked China to share details (schedule, content, 
etc.) on the planned revision contained  in "Regulations concerning Hygiene Supervision over 
Cosmetics ", and to resolve raised concerns. Concerning the latter regu lation, Japan asked China to 
provide a public comments process as foreseen in the TBT rules.  
2.66.   The representative of the European Union  asked China to explain the state of play of the 
new Chinese draft on Cosmetic Supervision and Administrative regulation a nd of China's plans to 
set up a differentiated approach between higher -risk priority cosmetic ingredients, requiring pre -
market registration and ordinary ingredients, requiring notification to competent Chinese 
authorities. The EU, welcoming this approach,  also asked China to share the planned timeframe for 
adoption of this change.  
                                                
3 G/TBT/M/65, paras. 2.41-2.43. G/TBT/M/70  
 
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  2.67.   The representative of China  thanked the EU and Japan for their continued interest and 
stated that no updates were available. The importance of the issue of new cosmetic ingredie nts 
and of carefully research ing it in communication with domestic and foreign business and industry 
organizations to find an effective resolution  was underscored.  A new classification system, 
applauded by the EU, was envisaged in the draft revision of the  Regulations Concerning the 
Hygiene Supervision over Cosmetics, published to the public by the legislation office of state 
council from 20 July  - 20 August 2016 for commenting and opinions. Further comments and 
suggestions would b e welcomed and processed b y the competent authority during further revision.  
2.2.3.4   India – New Telecommunications -related Rules (Department of 
Telecommunications, No. 842 -725/2005 -VAS/Vol.III (3 December 2009); No. 10 -
15/2009 -AS-III/193 (18 March 2010); and Nos. 10 -15/2009 -AS.III/Vol.II/ (Pt.)/(25 -
29) (28 July 2010); Department of Telecommunications, No. 10 -15/2009 -
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and 
Business Continuity Agreement" (IMS ID 274)  
2.68.   The representative of Canada  reiterated his delegati on's concerns with respect to India's in -
country test requirements for telecoms products, which would  hinder or possibly shut Canadian 
exporters out of the Indian market. Canada disagreed with India's blanket approach to testing in 
the telecoms sector, que stioning why Common C riteria ( CC) testing was not appropriate for India's 
telecoms framework, given that it was internationally accepted. Allowing accredited foreign 
conformity assessment bodies to test and certify to India's regulatory requirements would reduce 
testing costs and expedite foreign products entering the Indian market.   
2.69.   The representative of the European Union  requested that the requirements be postponed 
past the current date of 1 April 2017 pending clarification of the implementation modaliti es, and 
that until that time the status quo - meaning continued acceptance of foreign test results and 
suppliers being allowed to self -certify their products - would continue to apply. Testing modalities 
under the new requirement s was a crucial implementat ion issue. He asked whether Indian 
authorities would allow product -type testing rather than the excessively burdensome batch testing, 
which could cause importation delays and bottlenecks. The EU suggested that India consider a 
product -type testing based on  a prototype of the product being tested once. Concerning the 
applicable standards for testing purposes, the EU welcomed India's indication that relevant 
international standards would be relied upon when possible. On the requirement for in -country 
testing,  he failed to see how in this particular case, in -country testing would enhance the security 
of equipment or the networks. Foreign test results should continue to be accepted and flexibility 
should be provided for companies with a proven track record and w ho have consistently 
demonstrated over time the ability to self -certify products through adequately accredited and 
competent in -house laboratories. He welcomed India's confirmation that there would be no change 
to the continued acceptance of results of test results and certificates issued under assessments 
conducted under the Common Criteria Recognition Agreements (CCRAs) , and that Third 
Generation Partnership Project (3GPP) standards would be used for specific security aspects of 
telecom network equipment.  India was requested to refrain from developing home -grown specific 
standards, which would just add costs without increasing value in terms of enhanced security 
Finally, he urged India to continue to conduct the process in a transparent and inclusive manne r 
allowing interested stakeholders to provide input throughout the process.  
2.70.   The representative of the United States  said that while the postponement of the 
implementation of the in -country testing requirements had been helpful, there remained long -term 
uncertainty for India's trading partners. Several Members remained concerned that the 
telecommunications conformity assessment requirements could create an onerous and 
unnecessary trade barrier on companies, particularly SMEs. She asked that India issue a pu blic 
notice and notify the Committee of when the new in -country testing requirements would enter into 
force and the actual date producers would have to comply with them. While recognizing India's 
need to protect critical telecommunications infrastructure f rom spyware and malware attacks, 
other Members faced similar challenges and did not require in -country testing or MRAs. Globally 
known, innovative, and reputable companies were already developing innovative technology such 
as anti -spyware, anti -malware, se curity specialists, and private and international standards so as 
to secure networks from more and more sophisticated network attacks. What were the specific and 
unique circumstances in India that rendered such innovations inadequate? What specific inciden ces 
could be looked to in order to see India's justification for this regulatory approach? She requested 
that India provide more specific replies to these questions than had been provided in the past. In a G/TBT/M/70  
 
- 15 - 
 
  market where the most secure products were the mos t competitive, India's approach could 
discourage innovation and competitive technology development.  Another pending request related 
to India sharing the analysis on which the in -country testing requirement was based.  As stated in 
previous interventions, se curity testing that would potentially compromise companies' proprietary 
information such as source code and other intellectual property would potentially discourage 
companies from exporting high -quality telecommunications equipment to the Indian market, 
hurting India's trading partners unnecessarily and limiting Indian service providers from having 
access to the broadest possible range of network products and components. Finally, she 
encouraged India to accept international testing standards and schemes reg ardless of whether the 
tests were performed in India or at accredited labs outside of India.  
2.71.   The representative of Japan  expressed her delegation's support for the positions of the EU, 
US and Canada. Japan still had interests in the new Unified Access Serv ice License Agreement, and 
sought assurance that India's telecom regulations would not impede market access for foreign 
industries. Like other  Members , Japan was concerned that the testing modalities had yet to be 
finalized.  She asked that India clarify th e details and the development status of the 
implementation of in -country security testing as this was of interest to foreign industry.  
2.72.   The representative of India said that telecom networks were part of the Critical  
Infrastructure on which other critical i nfrastructures like power, transportation and defence also 
rode. The licenc e amendments dated 31 May and 3 June 2011 were mandated under on 
consideration of national security, and therefore required that the licensee shall induct only those 
network element s into the network, which had been tested as per relevant contemporary Indian or 
International Secur ity Standards such as IT and IT -related elements against ISO/IEC 15408 
standards, Information Security Management System against ISO 27000 series standards,  
Telecom and Telecom related elements against 3GPP security standards and 3GPP2 security 
standards, from any international agency or labs of the standards, for example Common Criteria 
labs in the case of ISO/IEC 15408 standards, until 31 March 2013. This h ad been extended up to 
31 March  2017. India would rely on the international s tandards to the extent possible. For IT 
products, testing carried out against CC Process under CCRA could be leveraged, although 
additional tests would be conducted if required in  the interests of national security. As had been 
previously clarified, CC was process based and used to certify the claims of the vendor on security 
features incorporated in the product, without certifying that the product had no vulnerabilities. The 
Commo n Criteria certification did not address National Concerns on the Security requirement of 
Telecom Networks. Telecom equipment was tested against 3GPP standards for operational 
requirements and did not have security standards per se for telecom equipment. The SA3 sub -
group had only been created in 2014 to work out the security standards for telecom equipment. 
3GPP, by its own admission , was in the process of developing security assurance requirements for 
Telecom Network elements and so far had only taken up one network element - MME.   
2.73.   In-country testing requirements had been incorporated only after wide consultation with 
various stakeholders such as  the Ministry of Home Affairs, s ecurity agencies and telecom service 
providers to address national security conc erns. In response to the suggestion that the new 
requirement should not apply to companies with a proven track record, it was noted that the 
guidelines were applied regardless of brand/size and geographical location, and were equally 
applicable to all manu facturers/vendors irrespective of the source of procurement and included 
domestic manufacturers. In response to the US request that the effective date be made available 
in a public notice, he said the effective date of 1 April 2017 had been issued and uplo aded onto the 
Department of Telecommunications website4 on 1 April 2016. Transition times  would also be made 
available there. Finally he said that these guidelines could not be considered a trade barrier as 
they were equally applicable to both domestic and  foreign manufacturers and vendors.  
2.2.3.5   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 -going revisio n and the Multi -Level Protection 
Scheme (MLPS) (IMS ID 294)  
2.74.   The representative of the European Union  reiterated his delegation 's systemic concerns 
about the Chinese regulatory framework on information security. This was a general concern – the 
EU intended to elaborate in more detail on specific sectoral implementation of these general 
                                                
4 http://www.dot.gov. in G/TBT/M/70  
 
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  provisions under the STCs 24 and 28 below5 concerning specific information security requirements 
in the banking and insurance sectors. China had developed a number of framewor k provisions on 
information security which had restricted the use of encryption products incorporating foreign 
technology in China. The existence of multiple, overlapping layers of regulation  impacting the 
same sectors created uncertainty about how all the  different pieces fit ted together. Therefore, 
industry still had a number of unaddressed questions on how to comply with these system 
requirements and their future implementation given that many of the requirements expressed in 
the general laws required fu rther implementation at a later stage. There were different pieces to 
this complex puzzle: the "old" OSCCA regulation on commercial encryption products which had 
been under revision for several years (an update of the state of play was requested); The Mult i-
Level Protection Scheme (MLPS), which introduced the notion of "critical infrastructure " and the 
classification of IT infrastructure in different levels with the consequence that as soon as a network 
was classified as critical infrastructure there were c ertain restrictions as to the type of equipment 
and technology that could be introduced  into the system , with a requirement for the use of 
products incorporating domestic technologies and whose intellectual property rights were owned 
by Chinese nationals.  
2.75.   More recently, the representative of the European Union noted, the National Security Law 
adopted on 1 July 2015  had introduced the notion of "secure and controllable" which meant that all 
key cyber infrastructure within China had to be secure and controll able. While this clarification was 
welcome (in the specific context of the STC dealing with information security in the insurance 
sector), questions remained about how this notion was going to be rolled out in practice and what 
its implications were in ter ms of hard ware and soft ware requirements in IT network equipment.  
2.76.   The most recent development concerned  the adoption by the National Peoples' Congress – 
on 7 November 2016 – of the new China Cyber Security Law which had a very broad scope of 
application a nd contained cross -references to the MLPS and the National Security Law, including to 
the concept of "secure and controllable". It applied to construction, operation, maintenance and 
use of networks and aimed inter alia  at protecting critical infrastructur e from cyberattacks. It 
contained some key provisions, for instance: regarding the introduction of a MLPS  for cyber 
security; on the need for products used in networks qualified as critical infrastructure to comply 
with mandatory requirements of relevant n ational standards; and, the need for critical equipment 
for cyber security to be certified by a qualified institution in China, with an indication that a 
catalogue of such critical equipment would be developed at a later stage. There were provisions for 
network operators of critical information infrastructure to be subject to direct government 
supervision and to obtain clearance from government for the products they used through a process 
which was qualified as a national security review to be conducted by the State -level Cyberspace 
Administration and there was provision for spot checks to be carried out by state level cyberspace 
administration for security risks of critical information and infrastructure. The cyber security law 
was intended for application from 1 June 2017.  
2.77.   The EU understood, based on bilateral consultations, that this law would require specific 
implementation and be a benchmark for future regulations in this area. Thus there could be 
implications for the on -going revision of the specific p rovisions in the insurance and banking sector 
and there was a need to understand how all the different pieces mentioned above (the OSCCA 
regulation, the MLPS, the National Security Law, the Cyber Security Law) would be applied in 
conjunction.  
2.78.   The EU had a lready mentioned several times the need for a transparent process and 
continued to urge China to notify under the TBT Agreement all relevant rules in this area. A good 
precedent had been set with the specific rules impacting the insurance sector and China was asked 
to extend this to any measure in this area. The EU regretted that neither the Cyber Security Law 
nor the National Security law had been notified in draft form under the TBT notification procedure.  
2.79.   Concerning standardization activities, China was urged to take into account relevant 
international standards and to allow for meaningful opportunities for foreign companies to 
participate in Chinese st andardization, notably through Technical C ommittee 260 which was of 
strategical importance in this area.  This technical committee had recently showed increased 
                                                
5 China — Banking IT Equipment Security Regulation (IMS ID 457) and China - Insurance Regulatory 
Commission (CIRC) Information and Communication Technology Regulation (IMS ID 489) , paras 
2.178.   2.184.   and 2.196.   - 2.211.   respectively,  below . G/TBT/M/70  
 
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  openness by allowing the participation of certain foreign stakeholders. The EU would welcome 
continued movement towards more inclusive participation of European stakeholders. Finally, the 
European Uni on could not emphasize enough the importance of international co -operation in this 
area. All countries faced global challenges in this field and it was in the general interest that 
regulations allowed the best technology available to be used globally in cr itical infrastructure for 
the purpose of enhancing security without, however, hindering trade in commercial encryption 
products.  
2.80.   The representative of Japan  supported the EU position. At the last meeting of the 
Committee, China had said that "the regulatio n on commercial encryption products had been listed 
in the 2016 legislation plan of the State Council of China and the draft was currently being 
prepared." In this regard, Japan asked China to explain the current situation and the future 
schedule of the re vision. In addition, some cryptography -related regulations were stipulated in 
"Banking IT Equipment Security Regulation " and "Insurance Regulatory Commission (CIRC) 
Information and Communication Technology Regulation " which had been notified to WTO. Japan 
asked if China could confirm whether or not IT Security Regulations such as OSCCA would be 
applied to these regulations. Moreover, with regard to the  cybersecurity law adopted on 
7 November 2016, Japan had submitted opinions during the public comment perio d of the first 
draft which had been published in July 2015 and for the second draft which had been published in 
July 2016.  
2.81.   The United States  supported the statements made by the EU and Japan.  
2.82.   The representative of China  noted that the new Cybersecurity L aw had been notified on 
7 November 2016 and would enter into force on 1 June 2017. This new law comprehensively and 
systematically defined the obligations and liabilities of various parts and bodies that constituted 
basic institutions in relation to equipm ent security, network operation security, network data 
security and network information security. This was a comprehensive, fundamental law in 
governing cyber security in China. Regarding specific measures, both the Regulation on 
Commercial Encryption Prod ucts and the MLPS would be revised and adjusted appropriately in line 
with the principles of cyber security newly published. In this process of revision, China would take 
into account its trading partners concerns and learn from their good practices so as to coordinate 
and advance work in both cyber security as well as trade development.  
2.2.3.6   Russia n Federation  – Draft Technical Regulation on Alcoholic Drinks Safety, 
G/TBT/N/RUS/2  (IMS ID 332)   
2.83.   The representative of the European Union  recalled the explanations p rovided by the Russian 
Federation at the previous meeting of the Committee on the procedure for adoption of technical 
regulations by the EAEU , in particular with regard to consultations within its member States, and 
invited Russia to update the Committee o n 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 into account 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 original text notified in 2012. The EU also r equested that sufficient time be 
provided for manufacturers to adapt their products to the requirements of the technical regulation.  
2.84.   The representative of  Guatemala  reiterated his delegation's interest in closely following the 
discussions on this measure.  
2.85.   The representative of the United States  indicated concern  regarding several other provisions 
contained  in the original draft  notified to the C ommittee in December 2012, s pecifically by the 
proposed definition of whiskies, in particular  the requirement that  they had to be aged for no less 
than three years. She remain ed concerned that alcoholic beverages were required to have an 
expiration date.  Additional concerns  regarded  the standards for production facilities and several 
conformity assessment procedures a nd their applicability to foreign manufactures. She request ed 
that Russia clarify that these requirements did not apply  to producers a lready subject to controls G/TBT/M/70  
 
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  by US  authorities.  She noted Russia's statement that the 2012 draft had been substantially 
modified in December 2013. She request ed that Russia re -notify  the latest draft of this t echnical 
regulation and provide  an additional comment period for stakeholder input prior to the effect ive 
date of the measure. She stated that this would enhan ce transpare ncy and mitigate any undue 
burden for exporters of alcoholic beverages to Russia . She sought clarification on whether 
voluntary standards for distilled spirits were to be applied as mandatory standards as well as  the 
mode of application  once finalized and implemented.  
2.86.   The representative of Ukraine  joined the concerns raised by the EU and US regarding the 
draft regulation. She reiterated that the costs on conformity assessment procedures should be 
equitable in relation to any fees chargeable for assessing th e conformity of like products of 
national origin as producers from other countries had to bear the costs associated with registration 
of legal entities on the territory of the Customs Union or enter into contracts with existing legal 
entities registered in  the territory of the Customs Union. She explained that the costs on 
conformity assessment procedures for those producers could be higher than the costs for 
producers from member States of the Customs Union. She requested that these concerns be taken 
into consideration to ensure that the requirements of the technical regulation were in line with the 
requirements of international practice .6 
2.87.   The representative of the Russian Federation  emphasized that the draft technical regulation 
had been elaborated in orde r to establish unified requirements for commercial circulation of both 
imported and domestically produced alcoholic products. He informed the Committee that the draft 
was still in development and that the Members of the EAEU had not agreed on a volume of 
consumer packaging for soft alcoholic drinks; restriction  of the use of sugar -containing products in 
the production of beer; use of restorative components, such as caffeine and taurine, in alcoholic 
beverages; prohibition on adding rectified ethyl alcohol i n wine; and form of confirmation of 
conformity of alcoholic beverages.  
2.88.   He said that Russia  could not provide detailed comment s on the points made by the US , but 
expressed interest in resuming bilateral discussions on those concerns. He reassured delegation s 
that all concerns had been taken into account as provided for under Article 2.9.4 of the TBT 
Agreement, and would continue to inform interested Members on further steps taken in this 
matter.  
2.2.3.7   Indonesia - Technical Guidelines for the Implementation of the  Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety, 
G/TBT/N/IDN/64 (IMS ID 328)  
2.89.   The representative of the European Union  reiterated the EU request for a substantive 
revision of the Toy Safety De cree No. 24. Given that the two-year implementation period had now 
passed (which was considered a pre -requisite to initiate such review), he urged the Ministry of 
Industry to proceed with a revision in an expeditious manner and asked what the timeline would 
be. There were some issues  of continued concern that the EU hoped could be addressed in the 
revision such as the removal of the discriminatory conformity assessment procedures for imported 
products compared to domestic products. The current practice was that imported products were 
subject to batch testing whereas domestic products were subject to production line sampling every 
six months. On testing , he asked that relevant tests be carried out outside Indonesia in an 
adequately accredited foreign laboratory. The two -year grace perio d that had been previously 
granted expired in April 2016 and industry was now experiencing delays and bottlenecks at the 
test facilities within Indonesia. He invited Indonesia to consi der a more flexible arrangement, o ne 
that required evidence of the compe tence of foreign labs to test toys while still providing the 
necessary flexibility for manufacturers to have tests carried out closer to their manufacturing 
facilities outside Indonesia. This could be achieved either by requiring adequate accreditation by a 
body which was an ILAC MRA signatory applying directly to the Indonesia authorities to be listed, 
or to allow subcontracting arrangements between Indonesian certification bodes and foreign labs. 
Neither of these su ggestions required a government -to-gover nment MRA. The participation of the  
KAN in the ILAC MRA established  trust between KAN and the other signatories and should 
therefore be a sufficient basis for the Ministry of Industry to accept test results from labs 
accredited by ILAC MRA signatories. He also urged Indonesia to ensure that the mandatory 
national standard for toy safety be fully aligned with the ISO standard on toy safety ISO 8124 of 
                                                
6 G/TBT/M/69, para.3.74  G/TBT/M/70  
 
- 19 - 
 
  2014 so as to eliminate any possible discrepancies regarding testing methods and certain limits 
that applied  with regard to the content of certain substances present in toys , in particular 
formaldehyde . The current limits of formaldehyde seemed to be based much stricter for infant 
clothing than for toys.  
2.90.   The representative of Japan  expressed her delegation's co ntinued support for the position of  
the EU. There were s erious delays in exports caused by a sequence of events such as sampling, 
testing, SNI certification and pre -shipment inspection . She invited Indonesia to revise the 
requirements as they appeared to b e more trade -restrictive than necessary . Like the EU, Japan 
had concerns regarding discrimination in testing frequency. Each and every imported shipment of 
toys was tested whereas domestic products were only tested once every six months. Regarding 
accredit ation requirements whereby only overseas laboratories in countries with an MRA with 
Indonesia were recognized, she said it appeared Indonesia had no such arrangements and 
therefore operators could not in fact use any foreign laboratories. Domestic laborato ries may not 
have the testing capacity to run smoothly and accurately. Therefore, Japan strongly requested that 
Indonesia reconsider the requirements and accept testing results from foreign laboratories. She 
asked that Indonesia update the C ommittee on the  current state of play.  
2.91.   The representative of the United States  said that despite years of bilateral discussions 
involving multiple government agencies and technical staff meetings with major US toy companies , 
no substantive progress had been made despite commitments to find a way to address US 
concerns. Were there further amendments envisaged and if so, what was the timeline and would 
this revision include recognition of ILAC -accredited laboratories? Would the revised regulation 
address the concerns on tes ting frequency, sampling documentation and substance restrictions? 
She affirmed US interest in working with Indonesia as it continued to revise this regulation and 
urged notification of the next draft at an early enough stage so that all stakeholders could  provide 
comments and for those comments to be taken into account.  
2.92.   The representative of Indonesia  noted that this concern had been raised in the Committee 
for some time. The national standard and conformity assessment procedures in question were still 
being reviewed.  As had been stated previously, all conformity assessment procedure schemes and 
parameters of chemical substances in toy safety were in line with international standards. She  
assured Members that Indonesia's policy was in alignment with the TBT  Agreement, and that it 
placed utmost importance on consumer protection. She reiterated h er delegation's openness to 
further discussion, including through bilateral mechanisms.  
2.2.3.8   Korea — Regulation on Registration and Evaluation of Chemical Material , 
G/TBT/N /KOR/305, G/TBT/N/KOR/305/Add.1, G/TBT/N/KOR/478, 
G/TBT/N/KOR/547, G/TBT/N/KOR/592  (IMS ID 305)  
2.93.   The representative of the United States  thanked  the Republic of Korea for its stakeholder 
engagement and receptiveness to input  and expressed her delegation's h ope for an ongoing, open 
and transparent dialogue, with Korea continuing to educate stakeholders on how to comply. She 
nonetheless reported that due to the significant burden of compliance, many US  chemical 
companies were considering withdrawing from the K orean  market, whic h would negatively impact 
Korea' s manufacturing sectors. The US  remain ed very concerned about the lack of transparency 
and regulatory consistency throughout the implementation , for example in light of regular 
complaints  about frequently c hanging guidance documents, many of which are not in English , 
which caused  difficulty given the large number of measures to be complied with.  Moreover, 
significant confusion and uncertainty existed  with respect to specific requirements and acceptance 
of notifications and registrations , especially for those using trace amo unts as inputs for production . 
To help increase transparency and compliance , her delegation suggested the setting up of a single 
portal or "window"  with a FAQ , which would  provide a single  location to access all relevant 
guidance/measures/amendments/regulations  and which could clarify any questions for industry. 
Recalling that Korea had  flagged in  the previous  two TBT meetings that it was preparing brochures 
in English , she welcomed the news  from their bilateral meeting that they would be  ready  by the 
end of the current year. 
2.94.   With respect to confidential business information  (CBI) and more specifically the plan of the 
Chemical Control Act (CCA) to disclose company -confidential chemical inform ation on the internet 
on 1 July 2016 , the US asked for confirmation that the Ministry of the Environment ( MOE) had 
issued a public notice on 30 May 2016 excluding non -hazardous substances. Her delegation further G/TBT/M/70  
 
- 20 - 
 
  suggested  that CBI protection of composition  and volume under the CCA should be automatic , in 
other words that  manufacturers should not have to submit a request.  Moreover, t here could  be 
limited scenarios where CBI was released to a requestor, but it should be based on agreed 
processes. With respect  to K-REACH, she reiterated her delegation's support for strong CBI 
protection of specific chemical identities, uses, and compositions, and repeat ed its request that the 
MOE allow such protection for more substances qualify ing as hazardous . Concerning  K-REACH joint 
registration, her delegation considered that the consortium formation process had  not been 
transparent and that there had been  a lack of guidance , resulting, for example, in some companies 
being intentionally excluded from consortia.  
2.95.   On the issue of Data Acceptance for K-REACH registration and Article 13 of the Final 
Presidential Decree, the US delegation requested confirm ation that quantitative structure activity 
relationship ( QSAR ) and computational tools could be accepted in order to  reduce du plicativ e 
testing. It was suggested that w hen QSAR or read -across data was submitted , the MOE and the 
National Institute of Environmental Research ( NIER) accept scientific experts'  statements and not 
require additional evidence for the waiving or omission data. An update on this since it was first 
raised in March 2016 was requested, as well as written reconfirmation that MOE would  accept EU 
REACH datasets to reduce duplicative testing for toxicity and ecotoxicity.  Finally, on Only 
Representatives (ORs) , the US acknowledged Korea's efforts to streamline OR requirements, and 
asked Korea to continue working to make procedures work smoothly.  
2.96.   The representative of Australia  expressed its continued interest in the issue as it continued 
to monitor the implementatio n of the regulations , given the importance the registrati on of 
chemical substances incurred  to Australian industry. Australia encourage d Korea to take a risk -
based approach following international best practice to ensure that K -REACH provisions reach ed 
Korea's consumer protection objectives while not distorting trade unnecessarily. On a positive 
note, his delegation welcomed Korea's initiative  to release brochures for businesses in English by 
the end of the year  and sought clarification of a date for recept ion of said brochures. Australia 
expressed interest in receiving guidance materials or any further information from Korea on the 
nature of the recent changes to the regulations.  
2.97.    The representative of the Republic of Korea  reported that its website had be en updated in 
order to  improve  the smooth implementation of K -REACH , and would enable  stakeholder s, 
including foreign , to provide comments or questions online . For the benefit of foreign companies, 
Korea had published some guidelines in English such as "Guidance on compliance procedures of 
the act on registration and evaluation of c hemical substances " and was working on the  translation 
of a guidebook and detailed guideline s of related ordinance which would be distributed within the 
year. Regarding the issue of CBI , according to the " Revision of regulation for operation and 
examination  result of chemical substances " which had been  announced on 8 July 2016, information 
on the handling condition of chemical substances classified as low hazardous material was not 
available on  the website. However, such information could  be made available to selected 
individual s after deliberation on the necessity thereof, if release  of the information was requested 
under the official information disclosure act. His delegation fur ther confirmed that exporters could  
register chemical material by simply submitting QSAR results with internationally verified  reliability 
without additional evidence for omission of related test data. In add ition, full text or test 
summaries  specified on dataset s used for EU REACH registration would  be accepted.  Korea 
committed to holding bilateral consultations to resolve any further issues raised in writing . 
2.2.3.9   European Union – Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down  detailed rules for the application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/246, G/TBT/N/EU/2 46/Add.1 (IMS ID 345)  
2.98.   The representative of Argentina  reiterated concern on the European Union's unjustified 
delay and the various instances outside the regular procedure that had been used to avoid 
responding to this STC, which had been raised since 2009.  Argentina had repeatedly said that 
Regulations (EC) 479/08 and 607/09 were in violation of the TBT Agreement and seriously affected 
the image and prestige of Argentine wines destined for the European market. By restricting or 
prohibiting the rights to use  certain terms on their labels such as traditional expressions "reserva" 
and "gran reserva" caused unjustified disruption in the trade of Argentine wines. He urged the EU 
to submit the proposed amendment as soon as possible and to explain how those request s that G/TBT/M/70  
 
- 21 - 
 
  had already been approved under the current technical approval process would be treated. He 
requested the prompt conclusion of formalities under the current regime.  
2.99.   The representative of the United States  again requested more transparency regarding the 
EU's application process for traditional terms for wine. US wine industry had been waiting patiently 
for over six years for the EU to act on their applications while the EU had provided no update on 
the status of their applications. Despite repeated en quiries from stakeholders, there had not even 
been any justification on why the re had been a six -year delay. The US again asked that the EU 
provide a status update on the applications submitted by US wine industry and to expedite its 
process and decisions so that this critical trade was no longer blocked. She requested an update 
on the ongoing revisions to the application review system which she emphasized should not delay 
or negate any decisions on the pending applications.  
2.100.   The representative of South Afr ica joined the concerns expressed by Argentina and the US 
and requested an update from the EU on the process.  
2.101.   The representative of the European Union  repeated what had been said at the previous 
TBT Committee meeting, in that an internal assessment on trad itional terms had been carried out 
within the EU involving stakeholders and experts from EU member States (in accordance with 
Article 114(3) of Regulation (EU) No.  1308/2013 establishing a common organization of the 
markets in agricultural products). The a lignment 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 agricult ural 
products. Therefore, no proposals on traditional terms were expected shortly and precise deadlines 
could not be provided. The EU would continue to make all possible and necessary efforts to 
simplify its current policy on protection of traditional term s and their indication on the labels of 
wines, taking into account trade partners' concerns. The concerns raised were noted and she said 
these would be considered when carrying out the complex simplification exercise. The EU remained 
open to bilateral disc ussion with trading partners at expert level.  
2.2.3.10   Chile - Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/96, G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1, G/TBT/N/CHL/221, 
G/TBT/N/CHL/282 (IMS ID 370)  
2.102.   The representative of Mexico  recalled  concerns previously raised on Chile's Food Health 
Regulations, Supreme Decree No. 977/96, notified to WTO Members on 22 August 2014, and on 
its amendment, which was circulated to WTO Members on 9 July 2015. Mexico also referred to the 
Amendment to Article  1 of the Food Health Regulations, notified to WTO Members on 7 January 
2016, which had the purpose of taking into account the provisions of Law No. 20.606 and Law No. 
20.869 on the nutritional composition of foods and food advertising . These regulations entered into 
force the 27 June 2016  and mandated the Ministry of Health to issue implementing regulations on 
food advertising, among others. Mexico expressed appreciation for the recent bilateral meeting 
and elaborated several specific concerns. First, Mexi co considered that Chile may be contravening 
Article 2.4 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).  
2.103.   Second, Mexico considered the wording "hi gh in …" to convey a distinction that may cause 
consumer confusion  and to raise labelling costs. Recent amendments proposed the power of the 
Ministry of Health to determine which foods have high contents of calories, fats, sugars, salt or 
other ingredients . These foods would be labelled as "high in calories", "high in salt", among others , 
and it would not be possible to market, promote or advertise them in primary, basic or secondary 
educational establishments. Mexico highlighted that the Guidelines of the Codex Alimentarius 
stated that: (i) the labelling should not lead consumers to believe that there is exact quantitative 
knowledge of what individuals should eat in order to maintain health, but rather convey an 
understanding of the quantity of nutrients co ntained in the product; and that (ii) 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.  
2.104.   Third, she said that the Food Health Reg ulations prohibition to advertise with elements that 
attract the attention of minors under the age of 14 of food that contained quantities higher than 
those specifie d in Table No. 1 did not apply  to foods containing energy, sugars, sodium or G/TBT/M/70  
 
- 22 - 
 
  saturated fats  in a natural form. Finally, Mexico asked Chile for the scientific or technical evidence 
to prohibit this advertising  and stressed that public policies such as nutritional education could be 
adopted without employing concepts of "good" or "bad" foods, in a ccordance with the Codex 
Alimentarius Guidelines. Mexico also asked Chile: (i) to harmonize the regulation requirements 
with the General Guidelines on Claims of the Codex Alimentarius; (ii) to provide scientific or 
technical evidence to support the use of the label "high in"; and (iii) to modify the classification of 
foods, which made a distinction between solid and liquid foods, so as to take into account 
international parameters and ensure food would instead be classified according to the category to 
which it belonged.  
2.105.   The representative of Guatemala  reiterated concerns regarding the measure expressed in 
past Committee meetings.  While Guatemala recognized the legitimate objective of protecting 
public health, it was concerned that these measures could hind er trade. Also, his delegation 
renewed concern on the lack of harmonization on food labelling across the region as a result of the  
introduction of different measures in each country.   
2.106.   The representative of Costa Rica  echoed Mexico' s concerns. As expressed in past TBT 
Committee meetings, Costa Rica questioned the compatibility of this food regulation. His 
delegation considered it constitute d a technical barrier to trade, especially regarding the lack of 
scientific and technical evidence and the lack of basis  on international standards such as those of 
Codex Alimentarius. He urged Chile to adopt other less restrictive measures in order to safeguard 
the legitimate objecti ve of protecting its population' s health. He a lso asked for an update on: 
(i) the current s tate of this regulation, since his delegation was aware that the measure entered 
into force at the end of June; (ii) the preliminary results from the implementation; and (iii) the 
monitoring mechanisms that had been established to ensure compliance.  
2.107.   The r epresentative of Chile thanked Mexico, Guatemala and Costa Rica for their interest in 
Supreme Decree No.977/96. He referred to Chile' s statements made in previous TBT Committee 
meetings. He pointed out that this measure was adopted to address the alarming obesity rates in 
Chile by i nforming the population on food's  nutritional composition. He mentioned that during the 
thematic session on food labelling, Chile had been  able to explain its regulation in detail and clarify 
Members'  doubts. The regulation enter ed into force on 27 June 2016 and it was being 
implemented nationally in accordance with the progressive implementation policy contained in it. 
His delegation affirmed that Chile' s measure complied with the TBT Agreement and expressed 
willingness to contin ue bilateral discussions to solve any outstanding doubts.  
2.2.3.11   India - Electronics and Information 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)  
2.108.   The represen tative of the European Union  thanked India for their bilateral meeting whilst 
recalling its two main continued issues of concern with respect to the compulsory registration 
scheme for electronics. With respect to the streamlining of the registration proced ure, the EU 
recognized that the Ministry of Communication and Information Technology in India was 
considering possible improvements thereto. His delegation sought an update from India about the 
state of play of internal reflections on their main request fo r single product registration by brand 
owner for multiple factories. Regarding their second main concern, the EU recognized that foreign 
test reports were accepted for safety -critical components on condition that either the foreign 
laboratories were partic ipating in the IECEE CB Scheme or they were accredited to international 
standard ISO/IEC 17025 by an ILAC MRA signatory. He reiterated his delegation's request for India 
to improve reliance on these two paths for the acceptance of foreign test reports in o rder to 
increase their acceptability beyond safety -critical components. Of particular interest to the EU 
would be the possibility for foreign labs to qualify and his delegation sought information from India 
on any procedure at the level of the Ministry of Communication and Information Technology or of 
the BIS which could be explored for that purpose. Finally, the EU reiterated its request for a longer 
time validity of test reports for registration purposes (currently limited to 90 days), while there did 
not seem to be any reason for such time limitation.  
2.109.   The representative of the United States  thanked India for their bilateral meeting and 
informed that it had submitted comments that week on India's Compulsory Registration Order 
(CRO). Of particular concern w as that the CRO's FAQ expanded its scope and that it was extremely 
burdensome to continually check for potentially contradictory updates, additions, and changes to G/TBT/M/70  
 
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  existing requirements, creating confusion and a lack of predictability. The US welcomed that  the 
Department of Electronics and Information Technology (DeitY) was now accepting BIS -accredited 
labs and had requested further information thereto. Her delegation also remained concerned about 
whether power supplies  for servers must be registered  as, if so, industry would need more time to 
adapt. US industry maintained that power supplies and power adaptors were not designed in the 
same way, did not have the same safety risks, and were therefore not identical in function.  US 
industry also noted that it w as an internationally accepted practice to test and certify a "power 
supply" as a "critical component" of the server, not as a standalone device.  Therefore, if the 
replacement units were already tested and certified as "critical components", why did the 
standalone devices need to be registered?  Her delegation expressed disappointment that their 
request to add a Highly Specialized Equipment (HSE) exemption had not yet been granted. As a 
member of the IECEE CB Scheme, the US encouraged India to accept that sc heme, which, whilst 
voluntary, obliged its regulators to accept international conformity assessment systems. India was 
also urged to reduce the number of product samples from two units to one unit and to increase the 
required time for sample delivery to be tween 30 and 60 days.  In many cases the product involved 
was a custom, made -to-order product requiring more time for production than that allowed for 
sample delivery, preventing companies from guaranteeing prices and delivery times to Indian 
consumers, in many cases businesses.  Her delegation warned that ultimately the CRO may 
discourage, not promote, business activity in India.  
2.110.   The representative of the Republic of Korea  expressed appreciation for the efforts and 
cooperation of the Government of Indian to improve this regulation including via the exception  by 
exempt ion of BIS marking on cells and the provision of an  additional grace period for the 
observation of  IS 16046. Nevertheless, following up on an unresolved concern, Korea requested 
the Indian author ities to accept test reports which had been approved by the IECEE CB Scheme  on 
the basis of Article 5.1 of TBT Agreement , recalling India's obligation, a s a member of the scheme , 
to mutually accept test results  of member countries , according to  IECEE 02 "Rules of Procedure " 
Part I. Korea stated that such accept ance of  test results would alleviate the unnecessary burden to 
exporting companies and relieve technical barriers  to trade . 
2.111.   The representative of Canada  expressed support for the interventions of Kore a, the EU and 
the US and associated itself with the request for an update on the status of the entry into force of 
the BIS marking requirement, which was expected to be enforced on 30 June 2016.  
2.112.   The representative of India began addressing Members' concern s by stating that the re was 
no requirement for in -country testing. Rather, the regulation brought into effect the Compulsory 
Registration Scheme (CRS) under the BIS Act for notified goods, the sample of which had to be 
tested in any BIS -recognized laborato ry. He added that there was a provision for overseas labs to 
seek recognition from BIS, based on the qualification criteria. Secondly, his delegation reiterated 
that the CRO was fully WTO -compliant. The IECEE CB was a scheme of reciprocal acceptance 
betwee n the National Certification Bodies , and not the regulators.  Therefore it did not necessarily 
find approval amongst all regulators. Nevertheless, the Indian Conformity Assessment process 
under the CRO still accepted CB test reports on critical components i f they were not notified 
separately . 
2.113.   On the issue raised regarding the FAQ, India stated that FAQs were being updated and 
published so as to assist industry and not to expand the scope of CRO. A Technical Advisory 
Committee had been set up to resolve the t echnical issues for industry that may arise during 
implementation of the CRO. This committee issued clarifications in the form of FAQs to avoid 
repetition of replies to recurring questions. To illustrate this point, in the area of power supplies, 
FAQs had clarified that the detachable power supplies identical to power adaptors were covered 
under the CRO. He pointed out that Circular No. 1 of 2016 (dated 8 September 2016) issued in 
this regard had also been notified to the WTO via document G/TBT/N/IND/47/Add .3 on 7 October 
2016, in which the implementation date had been extended to 1 January 2017 in view of 
difficulties expressed by industry. The Order had separately notified "Power Adaptors for IT 
Equipment" and "Power Adaptors for Audio, Video and Similar E lectronic Apparatus" via gazette 
notification dated 13 November 2014. Consequent upon this notifi cation of power adaptors for 
IS 13252 and IS 616, power supplies identical to power adaptors should comply with the Order.  
2.114.   Regarding HSE, one delegation had ma de a request that a new criterion be added to the 
HSE exemption, i.e. if goods were intended for sale to medium -to-large enterprises and not 
available to normal consumers. Indian authorities believed that the HSE exemption criteria could G/TBT/M/70  
 
- 24 - 
 
  not be extended as  product safety issues would arise even for the medium -to-large enterprises. 
Concerning the request that BIS -recognized laboratories should only require a product sample for 
testing in case a suspected non -compliance issue could not be resolved through exc hanges 
between the Certification Body and the manufacturer, after due consideration India found that it 
did not qualify under the CRO process. Regarding the question raised on the unique circumstances 
in India requiring companies to retest to BIS standards , he pointed out a number of typical 
variations: Use of components for Indian environment like Plugs & Sockets; Tropical country 
testing; and Different series formation requirements for India.  
2.115.   India had been asked to reduce the number of product samples fr om two units to one unit 
and to increase the required time for sample delivery to between 30 and 60 days. He responded 
that at least one sample from the range of products covered in the scope of registration was used 
for testing. In addition to the sample sent for testing, another sample from the same batch or lot 
was also drawn, sealed and labe lled, and left with the registered user as a counter sample, for use 
in case of any subsequent dispute. A time period of ten days had been allowed for submission of 
samples for surveillance testing, however more time had been allowed for products which were not 
available in stock or on the market. On the issue of product registration to be required by brand 
owner rather than by each factory, India informed the Committ ee that the matter was under 
consideration by the authorities. On a question from the June 2016 meeting on the need for 
prescribing a validity period of 90 days for test reports , India considered that the time period of 90 
days was sufficient for filing th e test report along with the registration application, once the test 
report was available. He concluded by informing the Committee that the Orders and their 
amendments were regularly being notified to the WTO . 
2.2.3.12   Peru - Act to Promote Healthy Eating Among Chi ldren and Adolescents , 
G/TBT/N/PER/89  (IMS  ID 383)   
2.116.   The representative of Mexico  reiterate d the trade concerns previously raised with respect 
to Law 30021 "Act to Promote Healthy Eating among Children a nd Adolescents" published on 
17 May 2013 in the Offici al Journal El Peruano . She noted that t hese concerns had first been raised 
in this Committee in June 2014 and reit erated on subsequent occasions. She indicated that this 
matter had been the subject of a bilateral dialogue  with Peru which was  appreciate d by Mexico . 
She elaborated that 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", was published on 18 April 2015 along with the approv ed technical parameters in 
respect of the content of certain substances (sugar, salt and sat urated fats) in processed foods. 
She explained that Peru had  recently informed Mexico that in September of 2016 it had notified 
the Regulation s of Law No. 30021, on  which Mexico will be making pertinent comments.  She then 
express ed the following concerns  of her delegation.  
2.117.   She acknowledged the legitimate objective pursued by the Peruvian measure, namely, to 
protect its population from chronic non -communicable disease s (NCDs) . She enquired as to what 
was the precise scientific or technical justification for the contention that the Act to Promote 
Healthy Eating among Children and Adolescents and  Supreme Decree No. 007/15/SA did  not 
create unnecessary obstacles t o Member s' international trade. She stated that i t was believed that 
Peru could be in contravention of the principles of the TBT Agreement, specifically the requirement 
to base technical regulations on international standards, established in Article 2.4 of the TBT 
Agreement , since the provisions contained in the act were inconsistent with the General Guidelines 
on Claims of the Codex Alimentarius (CAC/GL 1 1979, 3.5).  As had already been mentioned; 
Mexico considered  that every food had inherent nutritional characte ristics, as each person had 
different nutritional needs, and no food could  therefore be characterized as "good" or "bad" in 
relation to its nutritional content. She explained that the use of the term "HIGH" on food labels 
could arouse fear in consumers by leading them to assume tha t non -transmissible diseases such 
as obesity were caused by the consumption of specific foods.  
2.118.   She explained that t he Guidelines of the Codex Alimentarius state d that labelling "should 
not lead consumers to believe that there is e xact quantitative knowledge of what individuals 
should eat in order to maintain health, but rather to convey an understanding of the quantity of 
nutrients contained in the product", since 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".  She requested that Peru provide Mexico with an update on the current 
status of preparation of the measures that would  implement the provisions on  labelling contained G/TBT/M/70  
 
- 25 - 
 
  in Law No. 30021 and 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.  
She requested that a time -frame be provided in which to receive and consider comments from the 
various Members in the preparation of these measures.  
2.119.   The representative of the United States  supported  Peru's public health objectives of 
reducing obesity and related NCDs  and expressed appreciation for the exten sive bilateral 
discussions held on Peru's proposed regulations to implement the Healthy Eating Act.  She stated 
that the US would support the objective of improving consumer awareness of nutritional 
information for food items to encourage healthy eating and  inform ed dietary choices.  She 
highlighted the concern about the trade impacts of the implementing regulation and the 
development of a list of food products with high content of sugar, salt and saturated fat.  She 
explained that the US was planning to submi t comments on the notification G/TBT/N/PER/89  in the 
near future . 
2.120.   The representative of Costa Rica  reiterated its concern on the  issue, request ing an update 
from Peru on the present status of the planned measure, in particular, the work of the multi -
sector al committee with regard to the implementation of this law 30021.  
2.121.   The representative of Guatemala  reiterated  the sentiments made at previous meetings of 
the Committee. Her delegation  recognized  the legitimate objecti ve of protecting public health but 
remai ned concerned that these  measures could  hinder trade. She also express ed renewed concern 
over the lack of harmonization across the region with regard to food labelling as a result of the 
introduction of different measures in each country.  
2.122.   The representativ e of Peru acknowledged the commitment to ensuring public health safety, 
especially for the more vulnerable population: children and young adults. With regard to 
international commitments, she explained that this law 30021 sought to reduce problems of 
obesity and chronic NCDs by promoting the consumption of healthy food for children and 
teenagers. She explained that Peru, through a multi -sectoral committee , had been working on the 
regulations that would complement and implement this law and these measures wh ich includes , 
inter alia , advertisements, nutritional education, implementation of a nutritional observatory and a 
study on weight and obesity. She informed the TBT Committee that on 17 June 2016 the multi -
sectoral committee had finished drawing up the reg ulations  for law 30021 and notification 
G/TBT/N/PER/89  had been  sent, with a deadline of 8 December for comments, to WTO and the 
Andean Community. She requested that all M embers examine this regulation and provide their 
comments by the deadline. She stated  that this draft regulation contain ed a new proposal on 
technical parameters which replaced those adopted by decree 007/SA which was based on the new 
recommendations from the Pan -American health organization. The entry into force of this law 
30021 would  be 180 days after its publication in the official gazette and so law 30021 established 
60 days for comments on the law and 120 days for compliance with all the advertisements related 
to these products which would  be counted on the basis of entry into force o f the regulation. She  
expressed firm support for the liberalization of trade without establishing unnecessary o bstacles as 
illustrated in Peru' s commitments to the TBT. S he concluded by expressing Peru' s willingness to  
hold bilateral discuss ions on  these s tandards.  
2.2.3.13   European Union — Revised Proposal for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment , G/TBT/N/EU/283 + 
Add.1, G/TBT/N/EU/384 and G/TBT/N/EU/384/ Add.1  (IMS  ID 393) 
2.123.   The representative of Argentina  once again raised concerns with the EU's approach to 
determining the criteria used in identifying substances with endocrine disrupting characteristics, 
given their broad scope and potential impact on sanitary regulations and trade in agricultural 
products. He asked if the EU had already completed its analysis of comments received on the 
modification of Regulation (EU) No. 528/2012 concerning the making available on the market and 
use of biocidal products notified in G/TBT/N/EU/384. He reiterated that the propos al should have 
been notified to the SPS Committee, as had been done on the phytosanitary products proposal, 
given that both proposals and objectives were substantially similar.   
2.124.   Argentina was also committed to enhancing protection of human health and the 
environment, but these objectives should be pursued in a manner consistent with WTO G/TBT/M/70  
 
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  Agreements, and in this case, Article 2.2 of the TBT Agreement. The EU had opted for a proposal 
that lacked adequate scientific basis that would restrict trade more than nec essary. This was 
despite the Impact Assessment circulated by the EU which indicated the existence of less 
restrictive alternatives. Despite repeated calls for the adoption of an approach that took into 
account a full risk analysis, t he EU was solely using a hazard -based approach which was 
inadequate for properly assessing which substances with endocrine disrupting properties posed a 
real and significant risk to human health and/or the environment. If adopted, this proposal would 
lead to the probation of saf e substances since there was no assessment of hazard characterization, 
exposure and risk characterization. The adoption of the proposal could mean that active 
substances contained in biocidal products that had already been approved following a strict risk 
assessment carried out by the European Food Safety Authority (EFSA) would henceforth be 
regulated in line with an approach based solely on hazard identification. Their approval could 
possibly be reviewed and their maximum residue limit be set by default at  the detection level of 
0.01 parts per million (ppm), without the relevant scientific back up and in a manner that 
contradicts the maximum residue limits (MRLs) recommended at the CODEX level.  
2.125.   The proposal was also incomplete as it did not include essentia l elements of hazard 
characterization, such as the strength, severity and reversibility of effects. This could lead to 
disproportionate and unnecessarily trade restrictive measures that were inconsistent with WTO 
obligations. He noted that the EU had not t aken into account the European Commission 
communication that recognized that "Generally, a risk based approach allows consideration of 
proportionality when taking regulatory […] decisions".  The conclusions of the Impact Assessment 
were also not taken into account as the EU had selected Option 2. According to this Impact 
Assessment, the same level of human health protection could be achieved with Options 2 to 4, 
while Option 4 was identified as that which would regi ster the lowest impact in socio -conomic 
terms, both in the agricultural sector and in international trade. By choosing Option 4, the EU 
could have maintained the same level of protection while avoiding unnecessary trade restrictions. 
Argentina was also concerned that this approach, based exclusivel y on hazard identification, could 
also influence other EU policy areas. Should the proposal be approved as it now stood, Argentina 
hoped that both the repeals and the import tolerances be applied in a transparent and non -
discriminatory manner. Finally, he requested the EU to notify any modifications during the course 
of the adoption process and indicate how comments were taken into account prior to formal 
adoption. Any additional information related to the proposal would also be appreciated.  
2.126.   The representat ive of Canada  expressed his delegation's continued concern with the EU's 
proposed approach for the categorization of compounds as endocrine disruptors, in particular with 
respect to the EU's implementation of a hazard -based approach for the regulation of p lant 
protection products. While hazard identification was an important first step in the scientific risk 
assessment framework, it was also imperative that the potential adverse effects be put into 
context with consideration of potency and the level of like ly human and environment exposure 
based on co nditions of use. Using a hazard -based approach in categorizing endocrine disrupting 
chemicals could unnecessarily restrict trade. Canada urged the EU to rec ognize the importance of 
a risk -based approach in its e valuation of biocidal and plant protection products and the setting of 
MRLs for these products. Finally he asked that the EU respond to comments submitted to the 
Enquiry Point on 31 August 2016.  
2.127.   The representative of the United States  expressed her delegat ion's appreciation for the 
extension of the comment deadline as the proposals involved complex issues with potential 
significant impacts on international trade.  She hoped these comments would be taken into account 
prior to finalization of the measure. She reiterated her strong support for strengthening public 
health and environmental protection by properly identifying, understanding, and regulating the use 
of plant protection products that may have endocrine disrupting properties. However the US 
remained co ncerned that the approaches outlined by the EU in identifying endocrine disruptors, 
the accompanying impact assessment and communication published on 15 June may lead to 
regulatory outcomes that imposed unnecessary trade restrictions, without improving pub lic health. 
This could have far -reaching detrimental consequences to global food and agricultural production. 
She asked the EU to provide the scientific evidence used to justify the regulation as neither 
Regulation 1107/2009 which mandated the establishmen t of criteria, nor the EU roadmap 
published in June 2014, nor the impact assessment published in June 2015 , identified the scientific 
evidence used by the EU in the development and selection of options to establish  cut-off criteria 
for endocrine -disrupting  substances. Without this evidence it was difficult to understand the basis 
on which the EU had drawn  its conclusions. According to the report provided to the SPS Committee G/TBT/M/70  
 
- 27 - 
 
  in G/SPS/GEN/1448, a policy change to establish definitive criteria to identify end ocrine disruptors 
was required.  
2.128.   The US believed that the proposal under the biocides regulation should also have been 
notified to the SPS Committee as biocides were commonly used in medicine, agriculture, forestry 
and industry. It was puzzling that the not ification sent to the SPS Committee disclaimed SPS 
obligations and indicated that it was done for "transparency purposes". The US presumed the EU 
knew the rationale behind the measure and trusted that it would recognize in good faith the 
applicability of t he appropriate WTO disciplines prior to its enactment. She welcomed the news 
that the Commission would soon produce a revised proposal clarifying questions related to the 
derogation process and the application of the WHO/IPC definition of endocrine disrupt ors. In 
particular, the US requested that the EU provide a definition of "negligible risk", include the 
important aspects of exposure and potency, and follow a risk -based approach under which all 
substances designated by WHO/IPC as endocrine disruptors be eligible f or registration provided 
they m et the "negligible risk" standard. Concerning clarification on the application of the WHO/IPC 
definition of endocrine disruptors, the US hoped these changes would address previous questions  
regarding substances that  triggered other cut -off criteria such as those classified as carcinogenic, 
mutagenic or toxic for reproduction. She noted two key questions that had previously been raised 
that had not yet been responded to by the Commission. Firstly, could the EU clarify  whether it was 
possible to file an application for an import tolerance for a product if a substance was designated 
as an endocrine disruptor but not authorized for use in the  EU? If so, would that tolerance be set 
on the basis of a risk assessment, as sti pulated in Regulation 396/2005? Secondly, she asked that 
the EU provide a list of substances that would be identified as endocrine disruptors under the 
WHO/IPCS definition, as well as specific information regarding when and how potency and 
exposure informa tion would be taken into consideration.  
2.129.   The representative of Ecuador  asked the EU for information on the scientific or technical 
basis underpinning the parameters for evaluating the list of priorities or whether these would be 
subject to a new assessment . Given the enormous impact these measures may have on trading 
partners ' imports, there remained a lack of clarity surrounding the scope of the products that 
might be affected, the scientific basis for the regulatory decisions regarding the measure, the 
process for renewing authorizations for products that were currently being used safely, and 
information on substitute products that might be used without causing new risks to health or the 
environment or posing risks to food safety.  
2.130.   The representative of Guatemala  shared the concerns expressed by other Members. 
Guatemala was following this matter closely and hoped the EU would take Members' concerns into 
account prior to approving of the regulation.  
2.131.   The representative of Chile reiterated concerns on how the m easure had generated 
uncertainty in their domestic industry. He thanked the EU for the presentation made at the SPS 
Committee meeting which gave a better understanding of the issue. He requested that the EU also 
inform the TBT Committee on progress being m ade with regard to the proposal.  
2.132.   The representative of Colombia  shared concerned raised by other Members on the possible 
negative impact this measure might have on international trade. Colombian stakeholders had 
indicated that this measure could affect €1. 3 billion in exports to the EU. Trade in bananas alone 
could be affected by over €700 million. This was an unjustified trade barrier. While appreciating 
the information session at the SPS Committee, he asked that the EU take into account all the 
concerns r aised and looked forward to further clarification.  
2.133.   The representative of Thailand  highlighted that the definition of "negligible risk" remained 
unclear, and that the criteria for determination of endocrine disr upting properties used a hazard -
based approach  which may not affect the actual risk. Without sufficient scientific justification, and 
proper criteria, the regulation would significantly disrupt international trade. The draft regulation 
should be risk -based with the potential of substances and export a ssessments taken into account. 
Thailand encouraged the EU to apply a risk based regulator y approach rather than a hazard -based 
approach and hoped that the EU would take comments into account so as to resolve the concerns 
raised.  G/TBT/M/70  
 
- 28 - 
 
  2.134.   The representative of New Z ealand  echoed concerns raised by others, and hoped that the 
final shape of the proposal was one which did not unnecessarily restrict trade. She encouraged the 
EU to take into account comments from trading partners and looked forward to receiving a 
compiled  reply to those comments. Future iterations of the proposal should stress the need for a 
risk- and science -based approach. New Zealand looked forward to continued constructive 
engagement and , like Chile, appreciated the exchanges of information, including the useful session 
held during the SPS week. She asked that the presentation be shared with the TBT Committee 
delegates.  
2.135.   The representative of the European Union  thanked Members for their ve ry active 
participation in the i nformation session that had taken  place on 26 October 2016  in Geneva, at the 
occasion of the SPS Committee meeting . The EU was well aware of trading partners concerns and 
was acting in a very transparent manner. During the impact assessment, the potential impact on 
trade had been  carefull y evaluated, together with the impact on agriculture, health, the 
environment and socio -economy. The new drafts setting the criteria for plant protection products 
and for biocides were notified under the TBT Agreement , as they concerned  approval of 
substan ces. The draft act on plant protection products had also been notified under the SPS 
Agreement , as it was expected to have an impact on the settings of MRLs.  
2.136.   The original deadlines for comments on the drafts were extended until the end of August  
2016 so as  to allow Members time to properly consider the notified texts. The EU would reply in 
writing to comments received. The scientific criteria proposed in the draft acts were based on the 
widely -agreed WHO definition of an endocrine disruptor and were identic al in both legislations 
(biocides and plant protection). The criteria also specified how the identification of an endocrine 
disruptor should be carried out using all relevant scientific ev idence  selected via systematic 
reviews, and analysed via a weight -of-evidence approach. The proposed criteria would allow the 
EU to take appropriate and proportionate decisions on endocrine disruptors, while complying with 
international obligations. To this end, the EU had proposed to adjust the current plant protection 
products' derogations so as to make best use of available scientific evidence, including information 
on hazard, exposure and risk. The two draft acts containing the criteria needed to be adopted 
under the relevant regulatory procedures, taking into account M embers ' comments. The plant 
protection measure would need to be voted on by EU member States ' delegations in the standing 
committee. The biocidal measure would need to be adopted by the Commission. Following these 
steps, the measures would be subject to sc rutiny in the European Parliament and the Council 
before their entry into force. The EU was committed to act in a fully transparent manner and would 
keep Members informed on further developments . 
2.2.3.14   Indonesia – Ministry of Health Regulation 30/2013 on the inc lusion 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)  
2.137.   The representative of the European Union  reiterated its concerns about Regulation 
30/2013 of th e Indonesian Ministry of Health issued on 16 May 2013, as modified by Regulation 
63/2015 , introducing a mandatory health warning message on sugar, salt and fat content on labels 
of all processed foods , whose date of application had  been postponed until 201 9. The EU asked for 
information on studies on total diet undertaken by the Indonesian Ministry of Health  and the 
timing of the adoption of implementing provisions and technical guidelines for the regulation. The 
EU also requested that measures could  be not ified to the TBT Committee while in draft form, to 
ensure that comments from Members can be taken into account. In addition, clarifications were 
requested  on (i)  the way of placing nutrition information and related health warning s, the testing 
methods for nutrition levels and the conduct of risk assessment related to NCDs ; (ii) w hether 
Indonesia could  accept test results issued by laboratories other than those accredited by KAN or by 
other competent institutions having a Mutual Recognition Arrangement (MRA) with KAN;  and 
(iii) the possibility to place stickers after importation, and before placing the products on the 
market – e.g. in customs warehouses – as an alternative to labelling in the country of origin.  If 
Indonesia is drafting a new regulation on foo d labelling and advertising, including general 
guidelines on health labelling, the EU would be interested in receiving  relevant information.  
2.138.   The representative of Guatemala  supported the legitimate objective of informing a 
population on food products and its ingredients, but shared the concerns raised by other Members.  G/TBT/M/70  
 
- 29 - 
 
  2.139.   The representative of Indonesia  repeated that the implementation of the measure was 
postponed until 2019. Currently, Indonesia was still determining the categories of processed food 
results which would be mandatory. As for fast food products, the regulation would only be required 
for food provisions that had more than 250 outlets. The representative stated that testing reports 
from approved laboratories of other Members, based on a reciprocal  approach and in line with an 
international scheme, will  be accepted. In Indonesia, testing  mechanism s would  be in accordance 
with Indonesian rules and regu lations on  standardization and conformity assessment s. The 
labelling modalities related to including  sugar, fat and salt content and health messages were 
covered by government regulation 69/1999 on labelling and food adver tisement. This regulation 
stated  that labels should be readable, not separated from the package and not easily removed or 
damaged. The  objective was to give customers better health -related information. The modalities of 
the implementation of the regulation would  be defined by technical guidance currently being 
discussed. Indonesia said that the regulation would  be in line with WTO law an d indicated its 
availability  to discuss the regulation bilaterally.  
2.2.3.15   Ecuador – Resolution No. 116 of the Foreign Trade Committee of Ecuador of 19 
November 2013 and Technical Regulation of the Ecuadorian Standardization Institute 
RTE INEN 022 on the labelli ng of processed and packaged food products, 
G/TBT/N/ECU/19, G/TBT/N/ECU/19/Add.1 –Add.1 1 (IMS ID 411)  
2.140.   The representative of Mexico  reiterated the concern with respect to the labelling of 
pre-packaged foods under Ecuadoran Technical Regulation RTE INEN 022 o n the labelling of 
processed and packaged food  products. The objective of the regulations was "to regulate and 
control the labelling of processed foods for human consumption, in order to guarantee a person's 
constitutional right to timely, clear, accurate and non -misleading information concerning the 
content and characteristics of these foods, which enables the consumer to make the correct choice 
when purchasing and consuming them".  
2.141.   Mexico referred to Ecuador's latest notification G/TBT/N/ECU/19/Add.11 of 
18 December  2015, the subject of which ha d been a recurring feature of the meetings of the TBT 
Committee since 2014. Mexico appreciated Ecuador 's readiness to discuss Mexican industry  
concerns . However , concerns persisted in a few areas. Firstly, paragraph 5.5.4.  of the RTE INEN 
022 establishe d a graphic system of colour -coded charts for the labelling of processed foods, for 
the purpose of indicating the concentration ("high", "medium" or "low") of three components: total 
fats, sugars and salts. There was  no scientific support for this system based on the General 
Guidelines on Claims of the CODEX Alimentarius (CAC/GL 1 -1979, 3.5), which recommend ed not 
displaying or using labels or any di stinguishing device that employ  words, pictures or other 
graphics capabl e of arousing fear of consuming the food in the purchaser or consumer.  Secondly, 
the coloured bar system did not take into account Codex recommendations and could misl ead the 
consumer, since it tended  to stigmatize food products as "good" or "bad", based o n the 
concentration of their components. This could constitute an infringement of paragraphs 4 and 2 of 
Article 2 of the TBT  Agreement . Thirdly, Article 22 of t he Health Regulations stipulated  that "as 
described in the current Ecuadoran Technical Regulatio n RTE INEN 022 on the labelling of 
processed and packaged food products, any processed food for human consumption containing 
transgenic components must display the wording "CONTIENE TRANSGÉNICOS" 
(Contains  transgenics) on its labelling".  Industry had indicated that conventional products and 
GMOs  were, in principle, substantially equivalent, since there was no difference in their protein, 
nutritional, toxicological or allergenic composition. Therefore, the incorporation of this wording 
could be considered  more restrictive than necessary, thereby in contravention of Article 2.2  of the 
TBT Agreement . Fourthly, Article 3 of the Health Regulations and paragraph 3.1.2. of the RTE 
INEN 022 (1R) provide d for the incorporation of a definition of "N utritional claim", which differed  
from the framework definition of the Codex standard (CODEX STAN 1 -1985, 2). Mexico highlighted 
that in keeping with the provisions of Article 2.4 of the TBT  Agreement , the application of this term 
should conform with the provisions of the Gu idelines for use of nutrition and health  claims of the 
Codex Alimentarius (CAC/GL 23 -1997, 7).  Finally, Mexico considered that the measures on 
advertising, which prohibit ed the use of images of persons and animals, real or fictitious, in 
labelling could be  inconsistent with the provisions of Article 20 of the WTO  TRIPS  Agreement, since 
they might unjustifiably encumber the use of a trademark in the course of trade.  
2.142.   In view of the above, Mexico requested that Ecuador notify the Health Regulations on the 
labelling of processed foods for human consumption, in accordance with the transparency 
provisions of the TBT Agreement. Ecuador should also amend RTE INEN 022 so that concepts such G/TBT/M/70  
 
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  as "food" and "nutrition claim" would coincide with the definitions establishe d by the Codex 
Alimentarius and eliminate the difference betw een "food" and "processed food". An explanation 
should be provided on  the reasoning and the scientific evidence justify ing the use of the 
colour -coded graphic system for indicating the "high", "m edium" or "low" concentration of three 
components: total fats, sugars and salts, respectively. Mexico would also appreciate receiving 
information a bout the results of this scheme. Ecuador should also provide justification for or, if 
appropriate, envisage t he elimination of the requirement for the label to include the word 
"transgenics", where present; and finally, reconsider the restrictions on labelling advertising.  
2.143.   The representative of Guatemala  shared Mexico's concerns . Cert ain definitions did not 
match  with Codex regarding the lack of scientific grounds for these regulations. Guatemala 
expressed concern because it seemed that within the region there was not enough harmonization 
with regard to food labelling as evidenced by the different measures in each  country.  
2.144.   The representative of Costa Rica  echoed the concerns shared regarding this STC. In 
particular Costa Rica remained concern ed with the lack of scientific proof. Costa Rica asserted that 
Ecuador was steppin g aside from i nternational standards in the ir technical regulation INEN  022. 
Costa Rica invited Ecuador to consider other less trade -restrictive alternatives that were  in line 
with the principles of the TBT Agreement.  
2.145.   The representative of Ecuador  reiterated that Re solution No.  116 neither created  nor 
introduce d mandatory technical regulations, but rather incorporate d and withdre w subparagraphs 
subject to the Certificate of Recognition requirement. Ecuador highlighted that this was clearly an 
administrative measure for the purposes of customs contr ol. In short, this r esolution merely 
provided for the submission of a supporting document with the Customs Declaration as part of an 
internal administrative procedure and, consequently, was not a technical regulation. Ecuador noted 
that wit h regards to the  Regulation on Food L abelling and as previously indicated, Ecuador's 
Ministry of Health had conducted a national survey on health and nutrition in 2012, during which  it 
was discovered that Ecuador's epidemiological profile reflected an upward trend in the number of 
NCDs  affecting all segments of the population, regardless of age, place of residence or 
socio-economic level. He explained that this had inspired the Ecuadorian Government to develop 
policies geared towards the prevention of chronic diseases in a ccordance with international 
standards. Ecuador further elaborated that the Ecuadorian population had accessed appropriate, 
clear, accurate and non -misleading information on the content and characteristics of food. He 
concluded by stating that the Regulati on was duly notified pursuant to the TBT Agreement and at 
present, RTE No.  022 was being implemented, with both domestic industry and importers  
complying with its provisions without any problems.  
2.2.3.16   Russia - Safety of products for children and adolescents, G/ TBT/N/RUS/29 
(IMS ID 418)  
2.146.   The representative of the European Union  requested further information concerning the 
timeframe for the adoption and entry into force of the amendments notified under notification 
G/TBT/N/RUS/29. The EU asked whether the amendment s had been adopted since the last 
meeting of the TBT Committee, and if so, Russia was asked to clarify the date of adoption and the 
date of entry into force. Finally, the EU requested that Russia provide the final adopted text once 
available.  
2.147.   The represent ative of the Russian Federation  appreciated the comments from the EU on 
these draft amendment s, and referred to his delegation's previous statements on this issue at past 
Committee meetings. He noted that the regulation "On the development, adoption, amend ment 
and cancellation of technical regulations of the Eurasian Economic Union" did not fix time periods 
for inter -state discussions amongst EAEU m embers regarding draft technical regulations. Draft 
amendments to the technical regulation "On safety of produ cts for children and adolescents" were 
in the cou rse of discussion amongst EAEU m embers and the final date of adopt ion had not been 
defined. He stated that he hoped that these amendments would be adopted by April 2017, and 
that the Russian Federatio n would  continue to inform WTO Me mbers on this ongoing process.  G/TBT/M/70  
 
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  2.2.3.17   Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Alcoholic Beverages, issued under B.E. 
G/TBT/N/THA/437 (IMS ID 427)  
2.148.   The representati ve of the United States  reiterated its concerns about the continued lack of 
clarity regarding certain aspects of Thailand's measure dealing with alcoholic beverages control. 
The US stated that the measure should be suspended until clearer justification and  guidance could 
be shared, and asked for clarifications on the matter. The representative also requested relevant 
information on the scientific and technical information on which the measure had been  based. 
Thailand was asked to evaluate the impact of the measure after 18 months of implementation and 
to share results with trading partners. The US suggested work ing together with Thailand to identify 
unclear elements and improve and clarify guidance during the suspension. Finally the  US asked 
that concerns of  all Members be included in the minutes.  
2.149.   The representative of Canada  welcomed new developments regarding Thailand's 
regulations on alcohol, including interdepartmental working groups. He expressed hope that any 
new regulation would be developed in consul tation with stakeholders including importers. Results 
should be in line with the TBT Agreement, and any new regulations be clear and reduce 
uncertainty for wine and spirits exporters. Canada asked for the opportunity to review and 
comment on this process. Canadian wine labels were not intended to appeal to children or promote 
irresponsible consumption of alcohol. Canada emphasized the importance of informing consumers 
of the dangers of excessive consumption or abuse of alcohol.  
2.150.   The representative of the European Union  repeated its concern regarding the Regulation on 
Criteria, Procedures and Conditions for Labels of Alcoholic Beverages (B.E 2558/2015) , applicable 
since 19 October 2015. As had been stated in previous meetings and in - unanswered  - written 
comments submitted in December 2015, concerns deal t with the strict labelling requirements and 
lack of clarity of both the regulation and the technical guidelines on implementation . In particular , 
the EU had concerns with the lack of clarity of  provisions rel ating to messages permitted on the 
label, which could  lead to inconsistent interpr etations by economic operators ; and the impact the 
regulation could  have on specific terms commonly used in the EU linked to the ageing or 
maturation process and to the condi tions, quality or characteristics of the product.   
2.151.   The EU asked whether a working group had been set up to review and amend the 
regulation and technical guidelines and whether stakeholders would be consulted on modifications. 
The EU invited Thailand to giv e an update of the revision process as well as  clarification on 
whether the measure was currently being enforced. In addition, the EU asked Thailand to share 
information on the results of the consideration on graphic health warnings, and to notify the WTO 
of draft proposals on labelling of alcoholic beverages or graphic health warnings to allow for 
comments of Members to be taken into consideration . 
2.152.   The representative of Australia  noted that 15 April 2015 was the date of entry into force of 
the discussed re gulation , and that  manufacture rs and importers had  been required to comply since 
18 October 2015. Australian exporters, while keen on working together with the Thai Government 
to comply with the regulation, require d clear guidance to make this possible. Th ailand was 
encouraged to create clear guidance material for industry and trading partners, allowing 
stakeholders to use compliant labels rather than submitting labels for approval on a cas e-by-case 
basis, and to create imp lementation arrangements that did  not require products currently on the 
market to be removed.  
2.153.   The representative of New Zealand  expressed support for Thailand 's right to introduce new 
regulations to address specific public health concerns. New Zealand appreciated that in seeking to 
address  the harmful use of alcohol, the technical  regulation was directed toward s achieving a 
legitimate public health objective. New Zealand restated its concern that the labelling 
requirements were unnecessarily trade restrictive and that the regulation was unclear and 
unworkable. New Ze aland asked Thailand to update Me mbers on the meetings in Bangkok during 
which officials would draft amendments to the regulation and technical guidance. Could Thailand 
provide further information on these amendments and give an indication of when the updated 
draft would be notified to the Committee. Thailand was also asked to confirm whether 
amendments were being considered to both the regulation and the implementing guidance, and 
that the regulation would not be enforced until n ew amendments were made. She requested an G/TBT/M/70  
 
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  update on the proposal to implement a graphic health warning label system for alcoholic 
beverages, and in particular when the draft regulation would be notified to the WTO . 
2.154.   The representative of Japan  shared concer ns raised and asked Thailand to provide an 
update on the discussion on the revision of the measure.  
2.155.   The representative of Guatemala  was not  convinced that the discussed measure, 
establishing criteria for labelling of alcoholic beverages, would  be effective  in reducing 
consumption. She asked that  Thailand give a precise and detailed explanation of scientific 
evidence, or consideration that led to the conclusion that the measure actually reduce d 
consumption of alcoholic beverages without being more restrictiv e than necessary. Guatemala 
stated that the information, currently being banned, was not intended to stimulate consumption 
but to inform the costumers on the type of product in terms of quali ty-related characteristics. 
Additional information from Thailand on the measure would be most  welcome . Guatemala 
remained available for bilateral discussions if necessary.  
2.156.   The representative of Thailand  indicated that it had included  stakeholders in the 
development of the measure and would continue to do so, and that it  would share the scientific 
evidence on which the measure was based. The representative a lso stated that the measure did  
not address alcohol labelling in general, but rather prohibit ed certain practices also prohibited in 
many other countries. Thailand provided clarifi cation on several issues raised. She said the 
measure applied  equally to both locally produced and imported products. Effective communication 
channels between the Office of Alcoholic Beverages Control Committee and the industry have been 
estab lished to provide advice on implementation.  The measure allow ed the inclusion of information 
on quality and characteristics if sufficient evidence indicated  that the information is genuine.  The 
measure did  not overrule any intellectual property rights, whe ther copyright, trademark , or 
geographical. Thailand welcome d suggestions and deeper technical involvement from Members on 
how to improve public protection f rom alcohol harm while preserving free and fair  trade. The 
current measure did  not obstruct interna tional trade in alcohol and was in line with A rticle 2.2 of 
the TBT Agreement. The measure was fully enfo rced by October 2015. Cases had  been brought to 
court and no temporary protection had thus far  been granted. Whilst s uspension was not possible , 
an imp lementation evaluation was foreseen in due time and results would  be shared with 
Members . Thailand reiterated that it complie d with the principles of free trade while adhering to its 
responsibilities  to protect citizens from harm. The measure conformed to  international pr actices, 
laws and regulations on  alcoholic beverages control.  If a regulation on pictorial warnings was to be 
drafted, the WTO would be notified at an appropriate stage . 
2.2.3.18   China – Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022, G/TBT/N/CHN/1023, 
G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026, G/TBT/N/CHN/1029 
(IMS ID 428) 
2.157.   The representative of the Republic of Korea  reiterated concerns  raised on the Regulations 
for the Supervision and Administration of Medical Devices in previous TBT Committee meetings . 
China had not taken these concerns onboard , leading to unnecessary duplication of testing for 
imported medical devices that had already been tested, thus causing additional expenses and 
export delays. Korea reiterated its requests for China to recognize test reports issued by 
internati onally accredited laboratories. According to the written responses from China to Korea's 
questions with regard to the WTO Trade Poli cy Review, Article 57 of the Regulations stipulated that 
test reports issued by inspection institutes jointly accredited by the CNC A and the CFDA were 
recognized. Korea requested that China accredit international testing institutes including 
laboratories r ecognized by foreign regulating authorities and Accreditation Bodies of the ILAC, and  
laboratories that complied  with the OECD principles of Good Laboratory Practice for biological tests 
to avoid duplication of testing, additional cost and inspection delay .  
2.158.   The representative of Canada  drew the Committee's attention to the concerns raised in the 
last meeting .7 Canada requested an update from China on the progress of the regulation and 
restated its commitment to work  with a view to addressing these and othe r aspects of the 
regulation in a constructive manner.   
                                                
7 G/TBT/M/69 paras 3.183 -3.185  G/TBT/M/70  
 
- 33 - 
 
  2.159.   The representative of the European Union  acknowledged the bilateral meeting held with 
China in order to clarify certain matters . The EU reiterated concerns on the Chinese regulations 
notified under G/T BT/N/CHN/1022 -1026 and G/TBT/N/ CHN/1029. The comments had been  sent to 
the Chinese authorities on 23 June 2014 and raised subsequently in the TBT Committee  meetings . 
The EU refer red to its concerns raised during the last meeting of the TBT Committee in rel ation to 
the issue of the clinical trials required for the registration in China for Class II or Class III medical 
devices . China had clarified that Class I medical devices did not require this registration. The EU 
reiterated the concerns regarding the del ays with  this registration procedure, and the requirement 
to register the medical devices in the country of origin.  He highlighted the repeatedly raised 
concern with regard to the unnecessary duplicative clinical trials to be conducted in China. In the 
last meeting of the TBT Committee, the EU had requested confirmation from China that during the 
marketing approval of medical devices, manufacturers may present data obtained in clinical trials 
carried out abroad.  The EU had also asked whether 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 whether results of testing on Chinese populations living abroad or on 
non-Chinese population would not be accepted. As China was not in a position to fully answer 
these questions at that time , the EU again request ed further clarification on this issue, i n 
particular, on whether data  from clinical trials abroad were  sufficient for the registration certificat e. 
In the bilateral meeting with  China , the EU learnt that a new catalogue with 359 exempted 
products had been  publish ed in September 2016.  Furthermore, the EU requested that China accept 
test reports from foreign laboratories accredited by accreditation b odies that are members of ILAC, 
as an alternative to in -country electromagnetic compatibility testing in China. The EU further 
requested the exclusion from the registration certificate of the documentation on  product technical 
requirements  considered to be  confidential. Finally, the EU reiterated its request that China grant a 
transitional period of three years. Further guidelines detailing the relevant processes would be also 
welcome . 
2.160.    The representative of China  provided updates on two matters. Firstly, t he initial  update 
had occurred in August 2014 when  CFDA published the second and third catalogue on medical 
devices which could be exempted from clinical trials – this had been reported in previous 
meetings. In September 2016 CFDA published more medical de vices under both catalogues, 
including 267 items under the second catalogue and 92 items under the third catalogue so that the 
total number of medical devices exempted from clinical trials stood at 359.  China considered these  
development s to be progress .  
2.161.   Secondly,  in October 2016, CFDA published The Priority Approval Procedure for Medical 
Devices  which was  a regime similar to a fast -track procedure for 13 types of medical devices. He 
stated that this document established a priority approval procedure for t hose medical devices in 
Important National Science and Technology Projects and Important National Research and 
Development Plans. Those medical devices alleviating rare disease s, malignant tumors , ageing  
disease s, and  child disease s which satisfied  the urg ent need of clinical treatment  were also 
applicable.  
2.2.3.19   Ecuador – Proposed Motor Vehicle Safety Regulatory Requirements  
(RTE INEN 034), G/TBT/ N/ECU/32, G/TBT/N/ECU/32/Add.1 -11 (IMS ID 409)  
2.162.   The representative of Mexico  express ed concerns raised by domestic i ndustry with regard 
to the Fourth Revision of the Ecuadoran Technical Regulation RTE INEN 034 "Minimum safety 
requirements for motor vehicle parts", circulated on 31  October 2016 as document 
G/TBT/N/ECU/32/Add.11, despite having been published on the INEN website on 15 September of 
this year.  Mexico welcomed Ecuador's  efforts in heeding the request of Mexican industry to 
consider foreign standards as equivalent and to permit the submission of a manufacturer's own 
declaration as an import requirement.  Nevert heless, she underlined her delegation's continued 
concern , in particular with respect to its request that the  transition period for the new r egulation 
be extended to two years, with an entry  into force in April  2017, in order to allow full compliance  
with the new specifications contained in the measure , in accordance with Article 2.12 of the TBT 
Agreement . In spite of this request, she noted that it appeared that the measure had  already 
entered into force  and requested further clarifications from Ecuador. M exico further sought 
clarification with regard to what would be the standard or valid certification scheme for complying 
with the requirement to submit "an implemented comprehensive quality management system 
certificate". She specifically asked whether it would be ISO Standard 9001.  G/TBT/M/70  
 
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  2.163.   The representative of Ecuador  stated that the Fourth Revision provided  for acceptance of 
the standards of other countries as wel l as Blue Ribbon standards. Moreover, RTE INEN  034 was in 
force and applied  to domestic producers an d importers alike. Concerns raised during the present 
meeting would be addressed bilaterally in due course.  
2.2.3.20   Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial Council on 
the sale and marketing of energy drinks of 4 March 2014, (IMS  ID 442)  
2.164.   The representative of the European Union  shared concerns regarding the impact the 
measures being applied by the Kingdom of Saudi Arabia and other GCC countries were having  on 
trade in energy drinks . These largely discretionary restrictions could be imposed by lower level 
authorities , such as at a regional or local level making  it possible to create barriers on the ground, 
thereby  creating  regulatory uncertainty. As stated in comments submitted to Qatar and other GCC 
Members on 8 June 2016, the EU was also co ncerned about the lack of clear scientific 
substantiation of the statement to be included on energy drinks. The EU proposed that GCC 
authorities engage bilaterally on this matter and requested that Saudi Arabia provide an update on 
the measure.  
2.165.   The represe ntative of the United States  supported Saudi Arabia and GCC members in their 
efforts to develop a public health measure addressing caffeinated beverages. However the US 
share d concerns raised by other Member s and requested a status update  on the regulatory  
process. The US had submitted comments in April 2016 highlighting concerns with the required 
warning label on the product that must be larger than the ingredient statement; the 250 ml size 
requirement for ene rgy drinks; and  the limit of the recommended da ily consumption amount.  
There was also concern that the regional regulation would include national deviations on the look 
and placement of the label which could dilute the benefit of a regional measure.  
2.166.   The representative of Switzerland  remained concerned  with the mandatory statements that 
had to be placed on energy drink labels, as well as the restrictions on marketing. These measures 
appeared to be more trade restrictive than necessary. While sharing the objective of protecting 
public health and consumer  information, Switzerland questioned to what extent these measures 
would achieve those objectives. He looked forward to further engagement so as to ensure the 
proposed draft standard was in line with international standards. He asked that the questions 
submitted to the enquiry point be answered prior to the entry into force of the measure.  
2.167.   The representative of the Kingdom of Saudi Arabia , on behalf of GCC members, reiterated 
that the purpose of the measure was not to impede trade but rather to protect publ ic health. There 
had been positive bilateral discussion with interested trading partners so as to ensure the 
requirements did not create unnecessary obstacles and they looked forward to further bilateral 
engagement.  
2.2.3.21   Brazil — Draft Technical Resolution nº 6 9, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Composition, in Portuguese, in the Label of 
Personal Hygiene Products, Cosmetics and Perfumes G/TBT/N/BRA/608 ( IMS ID 443) 
2.168.   The representative of Mexico  reiterate d concern s with respe ct to Brazil's Draft Technical 
Resolu tion No.  69 of 9  September  2014. Her delegation considered  that by disregarding the 
existence of a widely accepted I nternational Nomenclature for Cosmetic I ngredients (INCI 
nomenclature) , the Draft Technical Resolution could contravene  the principles of the TBT 
Agreement and the Article 2.4 requirement to use int ernational standards as a basis. She added 
that INCI classification could be regarded as equivalent to the requirements of the Brazilian 
regulations for the purp ose of identifying the chemical composition of cosmetics and personal 
hygiene products, without the need for translation into Portuguese, since such translation would 
result in a measure more burdensome than necessary to fulfil the legitimate objective, in  
contravention of Article 2.2.  
2.169.   Further , Mexico was concerned that the distinction made between products from the 
European Union and those imported from other trading partners (specifically the Latin  American 
region), was in violation  of the principle of no n-discrimination contained in Article  2.1 of the TBT 
Agreement. Mexico therefore requested that Brazil share  information on the status of the 
regulations in question  and that their comments submitted on 19  January  2015 during the public G/TBT/M/70  
 
- 35 - 
 
  consultation reques ting the acceptance of the INCI nomenclature system as equivalent to the 
requirements of the Brazilian measure, be taken into consideration.  
2.170.    The representative of Brazil, whilst stressing that there were no updates to be provided 
since the last meeting, r ecalled that the measure in question was not yet in force and that 
comments received during the public consultation phase were still being reviewed by the Brazilian 
Health Regulatory Agency (ANVISA). He also recalled that the draft resolution had been deve loped 
in order to comply with a judicial decision establishing that labels of cosmetic products had to 
display information on the chemical composition of said products in Portuguese, in accordance with 
Brazil's code of consumer rights. However, this decisi on had been appealed, and its effects 
suspended until further decision by the Superior Court of Justice. He stressed that the draft 
measure did not prevent the use of the INCI; on the contrary, it created an additional 
requirement, applicable to all produc ts and regardless of their origin, that the chemical 
composition of cosmetics also be expressed in Portuguese. Brazil maintained that their position 
was justified and that the regulation was in full compliance with WTO rules . 
2.2.3.22   European Union – Common Criter ia for Information Technology Security 
Evaluation (Common Criteria) Certification in the EU (IMS ID 448)  
2.171.   The representative of China  said constructive dialogue on this matter had taken place 
during a bilateral meeting with the EU. China continued to remind  the EU that the CC regimes 
were within the scope of the TBT Agreement and in  particular, Art icle 8. China referred to the 
following obligations for Members in this regard: national treatment, avoidance of unnecessary 
obstacle to international trade, promp t acceptance of applications, expeditious undertaking and 
completion of conformity assessment procedures. China expressed concern with the refusal of EU 
member States' CC certification bodies to accept and process Chinese producers' applications, and 
about  the lack of opportunity for Chinese companies to join CC -related standard organizations 
such as JIL Hardware Attack Subgroup . The EU was urged to comply with its obligations under the 
TBT Agreement and to address the raised concerns in a timely manner.  
2.172.   The representative of the European Union  indicated that during the bilateral discussion his 
delegation clarified that, while remaining available for bilateral discussions, it did not consider the 
matter relevant under the TBT Agreement. As explained bilatera lly, China, according to the EU, 
failed to identify concrete measures, technical regulations or conformity assessment procedures, 
falling within the scope of the TBT Agreement. In the EU, there was no general mandatory 
requirement for certification of comm ercial encryption products, contrary to the situation in China 
which had led to several STCs  being raised in the Committee . Also, in the EU, companies were 
responsible for the secure transmission of data over system networks. The EU was of the view that 
regulatory approaches should not prevent authorities and IT system operators to use the best 
technology available, regardless of ownership of technology or location of equipment 
manufacturers. He clarified that while in China no foreign company had ever been  granted a 
license by OSCCA, some Chinese companies had obtained certification up to Evaluation Assurance 
Level (EAL) 4, which was high in the evaluation scale under the common criteria in international 
standards. He said that the JIL Hardware Attack Subgr oup was not a standards body, but a 
subgroup composed of EU member State experts set up under the Senior Official Group on 
Information Systems Security (SOG -IS). The SOG -IS comprised only nine member States along 
with Norway and dealt with information secu rity issues - those member States who were fully 
participating in the Common Criteria Recognition Agreement. While Chinese stakeholders could 
participate in the activities of European standardization bodies in information security, some 
European companies had difficulties in participating in the activities of Chinese standardization 
bodies, such as the Technical Committee 260 (TC260). The EU noted the shared interest in aiming 
for interoperable solutions using the best technology to  increase information sec urity and 
reiterated its willingness to discuss this further with China and any other interested parties. As 
cyber -attacks that threaten national security were a common challenge, the EU considered 
strengthening international cooperation in this area to be  of utmost importance and mutually 
beneficial. The EU invited China to continue to discuss these issues with the EU during existing 
bilateral dialogues on this matter as well as to engage more in cooperation and discussions with i ts 
main trading partners i n the field.  G/TBT/M/70  
 
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  2.2.3.23   China - Administrative Measure on Cosmetics Labelling (AMCL), 
G/TBT/N/CHN/1064 (IMS ID 456)  
2.173.   The representative of Japan  acknowledged the while the clarification provided by China  
that this measure would allow " over-labelling " on imported cosm etic products  was a positive step, 
there remained  three  concerns. Firstly, on manufacturer labelling, Articles 14 and 15 of the draft 
measures required, inter alia , labelling of the names and addresses of manu facturing 
subcontractors. This  could actually c ause consumer misunderstandings and market confusion. The 
manufacturer labelling should only present the name and address of the company with final legal 
responsibility for the quality and safety of the products concerned. Secondly, regarding the 
promotion al advertising of cosmetics efficacy claims, according to Article 19 and 20 of the draft 
measures, testing results issued by an "efficacy assessment testing organization" had to be 
disclosed. It was Japan's view, however, that since testing results could i nclude companies' know -
how, they should not be disclosed and that in addition, the "efficacy assessment testing 
organization" should not be limited to institutions inside China. Thirdly, Japan stated that in order 
to promote appropriate operation, it was i ndispensable that China provide clear guidance - detailed 
regulations - in addition to the draft measures themselves. Furthermore, as significant changes to 
existing labelling would be required to meet the conditions of the draft measures, and taking into 
consideration the negative influence on entry into the Chinese market, Japan  requested that China 
provide a sufficient transition period for the smooth implementation of the new labelling 
regulation. Japan asked China when the new implementation date would  be. Finally, Japan recalled 
that at the meeting in June, China mentioned that this draft AMCL  would be revised according to 
the contents of "Regulations concerning Hyg iene Supervision over Cosmetics"  which was the 
superior regulation to the draft measures . Japan requested that a public comment process be 
provided for the revision of "Regulations concerning Hygiene Supervision over Cosmetics " in 
accordance with TBT rules. In addition, Japan requested an explanation from China regarding the 
details of discus sion on manufacturer labelling and efficacy assessment testing in the studies of the 
reviewing process.  
2.174.   The representative of the European Union  reiterated the concerns raised during recent 
meetings of the TBT Committee, also sent to the Chinese authoritie s on 12 January 2015. In its 
written reply of 18 March 2015, China indicated that it would consider the comments received. The 
EU welcomed the possibility of labelling cosmetic products by means of stickers, but reiterated a 
number of issues included in th e notified draft . Firstly, the requirement for products to display the 
name and address of the manufacturer and of the subcontractors when part of the production was 
done by subcontractors. Secondly, the need to confirm that the efficacy assessment and the  
cosmetic claim verification could  be co nducted by any verifying organiz ation scientifically and 
technically competent to do so according to the criteria and guidance established by the China 
Food and Drug Administration (CFDA). The EU believe d that any re quirement for third party 
verification by a Chinese organization would be more trade restrictive than necessary.  Thirdly, the 
need to align the requirements regarding cosmetic claim substantiation with international best 
practices. The EU understood that t he process for the revision of the general legal framework for 
the placing on the market of cosmetics in China, i.e. the future Cosmetics Supervision and 
Administration Regulation, was on-going, and requested confirmation that the Administrative 
Measures f or Cosmetic Labelling be developed in parallel with this general framework and not 
enter into force prior to the Regulation. Furthermore, the EU reiterated a request for information 
on the implementation of the guidelines on the verification of efficiency of claims related to 
cosmetic products presented by CFDA at the technical meeting with their EU counterparts in March 
2015.  
2.175.   The representative of Australia  reiterated its interest in this issue  and supported the 
comments from Japan and the EU on labelling  requirements. Australia agreed that any 
requirements for third party verification by a Chinese organization would be more trade restrictive 
than necessary. Australia would welcome clearer guidance and longer implementation timeframes 
in order to allow tim e for industry to adjust to the significant changes. Australia emphasized the 
importance that domestic and foreign cosmetic manufacturers be treated equally with respect to 
product registration and approval. Australia noted that the regulations were still being drafted and 
welcomed clarification on these issues once finalized.  
2.176.   The representative of New Zealand  acknowledged the notification provided to the TBT 
Committee on this measure. New Zealand requested clarification on whether animal testing for the 
safety of cosmetic products would  continue to be required for imported cosmetic products if w idely G/TBT/M/70  
 
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  accepted alternatives beca me available and if all domestic and foreign manufacturers would  be 
treated equally with respect to product registration and approval . Finally, New Zealand joined the 
others in welcoming any updates on the timeline of adoption for these measures.  
2.177.   The representative of China  reiterated that c osmetic label ling was essential for consumers 
to understand basic information of cosmetic product s. China stated that labelling was one of the 
most important aspects of  cosmetic supervision for most M embers and indicated that the AMCL 
was still being drafted. China stated that CFDA would  follow international rules and give full 
consideration to valuab le inputs from interested parties to finalize AMCL, moreso, there was no 
timeline for this work thus far but the work was on-going. China concluded by stating that the 
CFDA actually foll owed up any reasonable comments from stakeholders. China explained tha t the 
original draft prohibited the modification or amendment of product(s) labelling where CFDA 
received a lot of comments and opinions on this requirement. China went on to state that after 
careful evaluation, CFDA improved this requirement and considere d to permit, to amend or end 
any Chinese language labelling for this imported product. China considered this to be an 
improvement.  
2.2.3.24   China - Banking IT Equipment Security Regulation (IMS ID 457)  
2.178.   The representative of Japan  remained concern ed about the Chine se banking IT equipment 
security regulation.  He asked China to provide update d information about the revision of "the 
Guideline for promoting  the Application of Secure and C ontrollable Information Technology in 
Banking Sector " as China had stated at the June 2016  Committee meeting that this was being  
review ed. Japan noted, in addition, that China had said that "opportunity to hear the comments of 
stakeholders is going to be arranged to issue the final draft " and asked for further clarification on 
this point . Regarding the requirement for source codes submission for risk assessment, Japan was 
concerned tha t, without clarifying the scope of data affected , it would be more trade restrictive 
than necessary in the light of the g uideline 's purpose. Therefore, Japa n asked China to revise the 
guideline not to be more trade restrictive than necessary in accordance with international common 
standards, ensuring transparency during the review process.  
2.179.   While the representative of Canada  underst ood China 's desire to minimi ze threats to its 
ICT infrastructure, Canada was of the view that China 's approach to "secure and controllable " ICT 
would decrease, not increase cyber security for China 's network and banking ICT infrastructure. 
Canada agree d with the concerns raised by Ja pan in this regard and emphasize d that, as drafted, 
China 's national cyber security regime and guidelines were far more trade restrictive than 
necessary to achieve their national security objectives.  
2.180.   The representative of the United States  had similar conc erns to those expressed above . 
Although China had suspended adoption of the ICT banking measure s, China appeared to be 
taking steps on adopting other measures for "secure and controllable " technology that raise d 
concerns over China 's commitments on nationa l treatment toward sectors that depend ed on ICT 
products.  For example, China was taking steps to impose  "secure and controllable " guidelines for 
ICT products in the insurance sector. The draft China Insurance Regulatory Commission 's ICT 
rules, which had be en notified to the TBT C ommittee in April  2016, replicate d much of the 
troubling language from the suspended ICT banking measure.  China was requested to inform the 
Committee of the status of the ICT banking measure s. The United States hoped that any draft 
measures  that China adopt ed and implement ed would  be transparent and consistent with China 's 
obligations  under the TBT Agreement.   
2.181.   The representative of the European Union  joined other delegations in raising concerns on 
this matter. While the European Unio n appreciated the suspension of the implementation of the 
banking guidelines, it was noted that there were other worrying developments on a system level in 
China, namely the adoption of the new Cyber Security Law raised under STC No. 58 – the EU 
hoped that  the on -going revision would address the concerns that had been raised by several 
delegations and their respective industries so far. To recall the EU's main concerns with respect to 
the earlier version of the banking guidelines: the disclosure of the sour ce code, the use of 
                                                
8 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-going revision and the Multi -Level Protection Scheme (MLPS) (IMS ID 294) , 2.74.  - 2.82.  above.  G/TBT/M/70  
 
- 38 - 
 
  indigenous technology, the reliance on home -grown standards and domestic algorithms to meet 
encryption requirements and the uncertainty surrounding the concept of "secure and controllable".  
2.182.   The European Union understood that the adopti on of the Cyber Security Law would also 
have an impact on the content of, for example, the sectoral implementation of China's information 
security policies. China was requested to elaborate on the relationship between the sectoral 
developments and the fram ework laws, including the latest Cyber Security Law. In terms of the 
process, the EU – like others – requested that the next phases of the revision be done in a 
transparent and inclusive way and that the revised draft be notified to the TBT Committee, 
following the example of the insurance measures.   
2.183.   The representative of  Australia  echoed the concerns of other Members.  Australian 
businesses ha d expressed an interest in the measure and the potential for the regulations to be 
more trade restrictive than nece ssary.  Australia asked for further information from China on the 
status of the regulations , including whether they would  be permanently withdrawn.   
2.184.   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  suspended 
and under revision . China would  take comments from stakeholders in to consideration . There was, 
he said, at the time of the meeting, no timeline for the release of a finalized ver sion. 
2.2.3.25   Indonesia - MOI 69/2014 Article 3: LCR Requirements for LTE Devices - 
Requirement that Domestic Component Level (TKDN) of LTE TDD & FDD broadband 
services equipment, G/TBT/N/IDN/103 (IMS ID 472)  
2.185.   The representative of Canada  said his delegation contin ued to have concerns with 
Indonesia's local content requ irements laid out in its rules and  procedures for the calculation of 
local content requirements for handheld devices (regulation no. 65/2016). He thanked Indonesia 
for the productive bilateral meeting s and looked forward to intersessional contact with Indonesian 
officials in order to resolve remaining concerns.  
2.186.   The representative of  the Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu  raised concerns about Indonesia's local content requi rements for 4G smartphones. 
Indonesia's Ministry of C ommunications and Information Technology issued regulation no. 27  in 
July, requiring LTE  smartphones to increase the quantity of locally produced content for mobile 
phones and packaging  and Indonesia's Ministry of Industry  had released a domestic calculation 
method  in September 2015. This measure  appeared to be  in viol ation with Article  2.1 of the TBT 
Agreement, since smartphones from other Members were treated less favourably as they had  to 
comply with l ocal content require ments. Smartphone companies had  to purchase threshold  value 
of Indonesian produced components and packaging to obtain an import licenc e. Chinese Taipei 
requested  Indonesia to bring th e measure in line with the TBT A greement.  
2.187.   The repres entative of Australia  asked Indonesia to explain how local content requirements 
included in the revised regulation on LTE technologies, notified to the WTO on 17 March 2016, 
were consistent with national treatment obligations  under the TBT Agreement . Austr alia continued 
to have an ongoing interest in the issue.  
2.188.   The representative of Indonesia  indicated that the Ministry of I ndustry decree 68/2015 ha d 
already been notified to the WTO. The update of this decree, decree 65/2016 , was still under 
revision. The n otification process of th e latter decree would  start once the revision process was 
completed . The number of products covered by this decree was reduced, establishing a 
components calculation for mobile phones, handheld devices and tablet computers. Indones ia 
believed the  decree and its revisions were in line with WTO regulation s. Indonesia was willing to  
discuss  concerns  bilaterally .  G/TBT/M/70  
 
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  2.2.3.26   China - Registration Fees for Drugs and Medical Device Products (IMS ID 466)  
2.189.   The representative of Canada  repeated its conce rn about aspects of the regulation, as 
reflected in the minutes of last meeting.9 Canada looked forward to an update from China .  
2.190.   The representative of the Republic of Korea  reiterated its concerns regarding fees for 
medical devices. According to the notic e on the measure of the administration of charging 
standards for drug and medical registration , made public on 27 May 2015 , different prices were 
used for Chinese manufactures and importers for first registration, discriminating against foreign 
manufacture s. At the TBT Committee meeting in November 2015, China explained that fees for 
imported devices included administration costs. Korea, while understanding the additional cost of 
on-site inspection, believed that these costs should be separated to secure tr ansparency and once 
again requested China to separate the inspection cost and registration fee.  
2.191.   The representative of Australia  repeated it shared concerns raised by Canada and Korea 
regarding the fee structure and process requirements for domestic and im ported drug and medical 
device products. She asked that China explain 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 al lowances . Furthermore, Australia asked China to indicate 
what the provincial price was and how it was determined, as some of the domestic prices were 
based on this price, and whether the same testing process requirements applied to the provincial 
price. An other question concerned the waiving of registration fees for SMEs with an innovative 
medical device the first time registered, and how innovative products were defined: what were the 
criteria and could both domestic and imported products be considered inn ovative? While Australia 
understood that on -site inspections at foreign facilities might be more expensive, the related fees 
should be transparent, non -discriminatory and include industry consultation prior to 
implementation. Australia looked forward to he aring China's responses and considerations on all 
issues raised.  
2.192.   The representative of China  took note of the statements, indicated that no updated 
information was availa ble and that its position had  been made clear at previous meetings and in 
minutes thereof.  
2.2.3.27   Brazil - Draft Ordinance Act N o. 374, 27 November 2014 (Portaria SDA/MAPA 
374/2014  replaced by Portaria SDA/MAPA No. 43/2016 ) establishes Quality 
Requirements for Wine and Derivatives of G rape and Wine, G/TBT/N/BRA/613, 
G/TBT/N/BRA/675 (IMS ID 47 0) 
2.193.   The representative of the European Union  thanked  Brazil for opening public consultations 
on Ordinance N o 43, 18 May 2016, notified as G/TBT/N/BRA/675  revising draft Ordinance Act no. 
374 establishing quality requirements for wine and derivatives of grape a nd wine which had been 
notified under  G/TBT/N/BRA/613 . The EU appreciated the bilateral contact  during the revision of 
the Ordinance. She asked Brazil for an update on the current revision and whether the EU's 
comments given on 18 July 2016 had been taken into account.  
2.194.   The representative of the United States  raised concerns with Brazil's wine regulation 
related to proposed minimum and maximum content requirements for alcohol in table and fine 
wines versus sparkling wine, volatile acidity, chloride sodium  and ash content . These requirements 
had no stated or discernible rationale while presenting challenges for imported wines. The US 
asked Brazil to provide specific health and safety reasons for these criteria, which were more 
stringent than most major wine p roducing nations. The US also restated its concerns about the 
definition of "cooler", which allow ed for the use of sugar but no other sweeteners, and require d a 
minimum of  10% fruit juice by volume. The US found these  definitions to be unnecessarily 
restri ctive. Coolers were currently sold freely and safely in the US, as was wine with added flavors 
from the Brazilian market . She asked  that Brazil  explain the regulation's objective and  provide  
evidence for this restrictive definition.  
2.195.   The representative fro m Brazil  said that p ublic consultations had been  held from 18 May to 
18 July 2016. Neither the previous measure nor its successor  changed labelling and quality criteria 
                                                
9 G/TBT/M/69 , paras . 3.233 -3.237. G/TBT/M/70  
 
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  currently in force and in line with MERCOSUR wine regulations. Brazil d id not foresee this measure 
as causing any impact  on trade , but would bring the concerns raised to the attention of officials in 
capital . The Ministry of Agriculture intend ed to invite interested parties to a public hearing on the 
final text.  Brazil had given due consider ation to all comments received, but the delegate had  no 
information on how and if these had been reflected in the final text. A date had yet to be set for 
the publication of the final rule .  
2.2.3.28   China - Insurance Regulatory Commission (CIRC) Information and 
Communication Technology Regulation (IMS ID 489)  
2.196.   The representative of Canada  said it shared China's interest in taking measures that were 
clear and transparent and which conformed to relevant international standards. Canada 
appreciated that China had revise d its October 2015 draft rules on which Canada had previously 
submitted written comments. However, Canada remained concerned that many of the rules as 
drafted were unclear and would have a disproportionate effect on non -Chinese suppliers, perhaps 
effective ly shutting these suppliers out of the Chinese market. In this regard Canada had 
submitted (to China's Enquiry Point on 17 June 2016) a letter detailing concerns on China's Draft 
Supervision Rules on Insurance Institutions Adopting Digitalized Operations, and looked forward to 
a response.  
2.197.   The representative of the European Union  said that this was a specific (sectoral) illustration 
of the general approach to information security; indeed, the same points made with reference to 
the banking deadlines under th e STC  No. 2410 were also relevant in this context, including the 
need to better understand the relationship between the sectoral implementation and the general 
framework including the new Cyber Security Law. The European Union had submitted written 
comments  to China on 10 June 2016 reacting to G/TBT/N/CHN/1172 and a detailed statement had 
been made in June listing all the EU concerns. The main concerns referred to, first, the need to 
classify information systems in the insurance sector in accordance to the g rid provided in the 
MLPS , which meant that as soon as an insurance IT System was classified as critical infrastructure, 
this triggered severe restrictions or even the impossibility to use products incorporating foreign 
technology. According to the notified  draft, insurance institutions would have to progressively 
phase out non -domestic cryptographic products, with the unintended consequence of in fact 
weakening, rather than strengthening, information and network security. A second concern raised 
was about t he notion of secure and controllable hardware equipment and software products. The 
third concern was about the need for equipment suppliers to disclose the source code of the 
equipment to the insurance institutions and for the latter to obtain ownership of  the source code. 
The latter was, however, an essential asset for information security equipment manufacturers and 
they would not be able to comply with this disclosure requirement without putting at risk the whole 
viability of their business. The fourth c oncern was the need for products and technologies to 
comply with national standards and encryption requirements and thus the mandating of national 
cryptographic application requirements and the use of domestic algorithms.   
2.198.   The representative of the United States  remained very concerned about China's suite of 
measures that appeared to discriminate against foreign technologies and firms in the name of 
information security. Notably the US was concerned about China's cybersecurity law that had 
recently passed a nd draft insurance sector informatization rules. The US thanked China for 
notifying CIRC and noted that the review of the insurance sector rules revealed that some 
problematic provisions had been improved, including the requirement on indigenous IP and 
domestic algorithms. However, the United  States still found many draft provisions problematic. 
The recently passed cybersecurity  law remained similarly problematic. The United States 
understood that the implementation date was 1 July 2017 and that this final law did not address 
US stakeholders ' key concerns. The main concerns of US industry with the final law were: 
2.199.   Critical information infrastructure (CII): As in the third reading draft, the law provided 
more details than in past drafts on the definition of CI I which stated the ultimate scope of CII 
would be defined by the State Council at a later date.  
2.200.   Data flows: The final law stipulated that domestic storage of any personal information or 
important data may only cross borders for business reasons and if it had passed a (currently) 
undefined security audit.  
                                                
10 China - Banking IT Equipment Security Regulation (IMS ID 457)  paras 2.178.   - 2.184.   . G/TBT/M/70  
 
- 41 - 
 
  2.201.   Security r eview:  The final law maintained a reference to a cyber security review which 
critical network equipment and products had to meet in order to be sold in China. In addition, 
network operators had t o ensure compliance with a cyber security multi -level protection scheme. 
This cyber MLPS had to be based upon an existing MLPS framework which prohibited purchase of 
foreign technology at some risk levels.  
2.202.   Secure and controllable information: The  United St ates remained concerned over what 
seemed to be a widespread effort from China to impose secure and controllable requirements on 
companies using ICT products that unnecessarily disadvantage d foreign ICT firms. Such 
requirements ran foal of commitments made by their respective presidents and that had been 
restated in subsequent meetings of the Joint Commission on Commerce and Trade (JCCT) and 
Strategic Economic D ialogue.  While the requirement of indigenous R&D had been removed from 
the insurance rules, they s till seemed to require insurance institutions to give preference to 
products that were secure and controllable. The draft cyber security law introduced an equally 
undefined term "secure and trustworthy". The SIRC regulations on secure and controllable stat ed 
that these institutions needed to promote gradual implementation of the secure and controllable 
technologies. This was a major concern for US ICT companies given that "secure and controllable " 
was not clearly defined. The United States was concerned tha t since no further clarity had been 
provided on the meaning of secure and controllable and that it had been known and understood in 
the past to include references to domestic technology requirements, companies were already 
interpreting this language conser vatively meaning that they were required to procure only 
domestic goods. This was similar to trends seen in the banking and other industries in China that 
were deemed critical infrastructure. China was asked to publish a clear definition of secure and 
controllable; it was noted that some information had indeed been provide d in bilateral discussion s 
on the day of the meeting.  
2.203.   Domestic c ryptography: the United States was pleased that China had explicitly removed 
the mandate for domestic encryption in the draf t insurance rules; there was, however, still a 
reference to the "national implementation requirements on cryptography in the financial sector " 
without specifying what these requirements were. The United States was concerned that a 
domestic Chinese encrypti on standard would be mandated given that China 's national 
requirements on cryptography in the financial sector generally promoted all -around adoption of 
domestic algorithms.  For example, the January 2014 "national work plan for promoting application 
of cry ptography in financial sector " called for complete adoption of Chinese domestic cryptographic 
standards and related specifications by 2019 for products such as internet browsers, PCs, laptops, 
mobile phones, and servers. Although items that did not have cr yptography as their core function 
were still  able to be sold in China, the g uidelines from 2014 covered products including phones, 
servers, laptops, etc., which overlapped with non -core function items. China was asked to make 
more clear in Article 54 that domestic encryption was not required by these rules.  
2.204.   Multi-Level Protection Scheme: It was noted that the draft insurance rules also appeared 
to continue to discriminate against foreign providers by mandating that all insurance in stitutions 
within China fo llow the MLPS requirements that all products classified as security level 3 and above 
use domestic intellectual property (IP). The MLPS was inflexibly prescriptive and could restrict the 
ability for consumers to purchase technologies established as safe ev erywhere else in the world.  
Other Members had rules to ensure security of critical infrastructure, but China was now – without 
explanation – including non -critical infrastructure. Moreover, the draft Cybersecurity Law appeared  
to expand  the scope and appli cability of MLPS to cover "critical information infrastructure ", without 
providing a definition of critical information infrastructure. China was urged  to ensure that i t 
adopt ed an approach that was non-discriminatory and which focused on legitimate securi ty 
concerns within a clearly -defined category of critical information infrastructure.  
2.205.   Information Security System Certification:  The insurance rules also require d that 
information security system certification be accredited by China 's National Certificatio n and 
Accreditation Administration (CNCA), which could  unnecessarily raise costs or cause potential 
threats on their confidential information.  It was unclear what the specific requirements for 
certification would be, whether there were other options for ce rtification, and what kind of 
information would be requested from a company to ensure that it me t licensing requirements.  
China needed to  recognize relevant international certification results to remove unnecessary or 
duplicative requirements.  G/TBT/M/70  
 
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  2.206.   The represen tative of Japan  support ed the positions of Canada, US and EU regarding this 
issue.  In Japan 's view there were unclear articles regarding terms , definitions, concrete 
requirements for examination and evaluation, and the scope of regulation . Japan 's concern was 
that market access of foreign companies to China might be hampered depending on 
implementation. Japan request ed China to clarify the terms , definitions, the concrete contents of 
requirements and  the scope of regulation, and to ensure transparency.  
2.207.   As Japan had previously  explained , Article 25 in particular required insurance institutions 
to use technologies and products complying with national standards and encryption requirements. 
Those requirements could be implemented in a way which was  more trade restrictive than 
necessary upon import of relevant products. In addition, conformity assessment procedures of 
those requirements could be regarded as questionable, if they contained requirements of source 
code disclosure , etc. Japan asked China to clarify i n concrete terms which requirements or 
conformity assessment procedures were to be applied. It could be the case that foreign companies 
were disadvantaged compared with domestic counterparts, even if those requirements would be 
equally applied to foreign a nd domestic companies. Japan requested China not to apply those 
requirements. Moreover, Japan 's view was that the MLPS referred in Article 56  might cause 
discrimination of foreign companies by requiring Chinese intellectual property in core technologies 
or by requiring domestic certification in China. Japan asked China to clarify the implementation 
procedure of MLPS.  Japan also requested China to revise the draft regulation so that it would not 
to be more trade restrictive than necessary in accordance with international standards.  
2.208.   The representative of Australia  reiterated her delegation's concerns and echoed those 
expressed by other Members regarding the proposed Information Communication Technology 
Regulation  (CIRC) and the Cybersecurity Law.  While Austral ia understood China's desire to protect 
ICT infrastructure, Australia  question ed whether the proposed measures were necessary to 
achieve this objective. Australian businesses ha d expressed great interest in these measures and 
had raised concerns about the potential of the measures to limit their ability to operate in the 
Chinese market. While Australia appreciated that China had notified the measure and had 
amend ed certain aspects of it, there remained concerns about potential discrimination and 
unnecessary  barriers to trade . The representative of Australia sought further information about the 
objective of the requirement that certification be completed by bodies accredited by the 'CNCA '. 
Requiring domestic certification could  afford less favourable treatmen t to foreign suppliers, and 
might  not provide sufficient protection to commercial information.  It was suggest ed that China 
consider recognition of relevant international certification bodies, as outlined in Article 5 of the TBT 
Agreement.  
2.209.   In addition, Aus tralia noted that the regulation require d data from China to be stored in 
data centres located within China 's borders , and the design of the computing room conform to 
national standards.  Australia was concerned that these country -specific requirements could 
disproportionately impact international firms that r an their ICT systems as global platforms.  It was 
important to avoid onerous testing and certification requirements that would either be 
unnecessarily burdensome, discriminatory, include a review of sour ce code, or other sensitive 
business confidential information. Australia asked for further information from China about the 
details of the provisions, including the objectives, definitions of key terms in the certification 
requirements, and current status of the reforms, under both the Insurance Regulatory 
Commission 's ICT Regulation and the Cybersecurity Law. Australia was still awaiting responses to 
a number of questions r aised at previous TBT meetings – as well as to written comments – and 
suggested that  the implementation of the measures be delayed until there was further consultation 
and greater clarity on different aspects of implementation.  
2.210.   The representative of Mexico  supported delegations that had spoken and asked China to 
respect the principles ens hrined in the TBT Agreement.  
2.211.   The representative of China  said that the regulation was aimed at ensuring information 
security in the insurance sector which was essential to preserve  financial security in China. The 
rule had been drafted in a very transparen t way and would, he said, be applied in a non -
discriminatory manner. China was not of the view that it was discriminatory: regarding commercial 
encryption, the relevant regulations in China applied equally to domestic and foreign products. 
Dozens of foreig n companie s had obtained production licenc es in China and they did their business 
well. Thus, China's requirements regarding secure and controllable did not discriminate against 
foreign product services and technologies. In response to concerns about the t erm "secure and G/TBT/M/70  
 
- 43 - 
 
  controllable", it was explained that the criteria for the determination of what constituted "secure 
and controllable" were the following. First, a user's information system shall not be remotely 
controlled without their knowledge. Second, a  user's data and information should not be obtained 
without their prior consent. Third, the products of services provided using a user's information 
system should  not stop services without a justifiable reason. It was noted that the term "secure 
and contro llable" had not been  created by China, it was used outside of China as well. Finally, 
some Members ' concerns about "data residency " and "cross-border data transfer " seemed 
problematic to China since these issues went beyond the scope of the TBT Agreement  and, 
therefore, the TBT Committee was not the appropriate forum to discuss them in . 
2.2.3.29   Brazil - Toy Certification; Ordinance No. 489, No. 310 and draft Administrative 
Rule No. 321, G/TBT/N/BRA/612 (IMS ID 478)  
2.212.   The representative of the United States  said that her delegation continued to  monitor this 
measure  and expressed concern about the impact of these requirements on trade with Brazil in 
this sector, particularly INMETRO 's Object Registration S ystem which involved high costs  without 
comparable improvements i n safety. While recognizing  the objective of improving consumer 
information, she noted that it was unclear how the registration system and labelling requirement 
increased consumer safety beyond the current system.  The US expressed concern that many SMEs  
and developing country exporters may be forced to abandon the Brazilian toy market , which would 
reduce  consumer choice .  
2.213.   In particular, the requirements to register toys in a "family of products"  appeared to be 
unnecessarily burdensome. As noted in previous STC interventions, this approach was problematic 
when implemented for medical devices. Her delegation understood that the final ordinance was 
still under review despite expectations that final guidance would be made available to exporters by 
this point in the year. She asked for clarification on certain issues: (i) whether a final measure 
would be adopted in 2016; (ii) who would supply the sticker labels with the registration number; 
(iii) whether a company could print the registration number directly on th e packaging; 
(iv) whether the filming requirement would be removed; (v) whether the confidential business 
information required as part of the certification process requested to ensure inputs' traceability; 
(vi) whether other methods had been  considered tha t did not require the submission of sensitive 
information.  
2.214.   Concern ing the specific testing requirements for the migration of certain elements , she  
expressed the hope that the  final o rdinance w ould only require tests which w ere applicable based 
on the toy model and age rating. Also, the US was concerned that the certificates of conformity for 
testing models 2 and 5 would expire in three years, which wa s insufficient as most toys ha d a 
longer market life than that. The US  looked forward to  working bilaterall y with Brazil and remained 
open to discuss within the U.S.-Brazil Commercial Dialogue . 
2.215.   The representative of the European Union  supported the US intervention. The EU 
understood the intention behind the registration requirement, which was to improve traceab ility of 
toys, to enable a more effective enforcement of product recalls and to provide more information to 
consumers about the toys. This database would enable consumers to access and search the 
different toy products by their registration number. The EU invited Brazil to consider less 
burdensome alternatives, in particular on the narrow family concept of products which would be a 
determining criteria for registration. This narrow concept of family products was overly 
burdensome as it could result in unnec essary registrations for toys with substantially identical 
safety properties without comparable improvements in safety . 
2.216.   As mentioned previously concerning registration, t he EU reiterated its  toy industry 
proposal to use a registration system per each produ cer or importer combined with a requirement 
for toys manufacturers to have an internal traceability system capable of tracking relevant data on 
each toy, such as production line, date and batch number, to enable effective enforcement of any 
product recalls . The EU understood that INMETRO's regulatory process was reaching its final stage 
and the final version of Ordinance 489 could be adopted before the end of 2016. The EU urged 
INMETRO to take into account the comments submitted by regulatory authorities an d stakeholders 
in order to find a balance between the legitimate objectives pursued and the business realities in 
the toy sector. Furthermore, like the US, the EU requested confirmation that the filming 
requirement for  testing would be removed from Adminis trative Ru le 321 as Brazil had previously 
indicated.  G/TBT/M/70  
 
- 44 - 
 
  2.217.   The representative of Canada  thanked  Brazil  for its engagement on the toy safety 
measures.  She echoed the concerns raised by the US and the EU and said that in the previous TBT 
Committee meeting  Brazil had indicated that it expected to have a final rule by August 2016. 
Canada requested  an update on the status of Administrative Rule 321  and asked whether the final 
draft measure w ould be notified to the  WTO. 
2.218.   The representative of Brazil  said that the regula tion aimed at safeguarding the legitimate 
policy objective of protecting children 's health and safety,  one shared by all Members.  He said that 
the purpose of the measure was to create a direct link between INMETRO and the producers, as 
well as establishing  a registration procedure to facilitate access by consumers to certification 
information  through its website. This would improve the Brazilian framework of conformity 
assessment in terms of transparency and traceability . Brazil believed that the requiremen ts of the 
measure conformed to international best practices and were those that better address ed Brazil 's 
needs and circumstances . The registration system was a legal requirement established in Law 
12.545/2011 and in CONMETRO Resolution 5 of 2008, which ha d to be reflected in these 
regulations. He recalled that this registration system was implemented in other sectors in Brazil 
without difficulties .  
2.219.   Concerning the publication of the final rule , he expected to have a final rule by the end of 
December 2016. Regarding registration num bers, Brazil clarified that INME TRO had a sticker label 
to assess conformity with the product registration number, which was provided by a conformity 
assessment body hired by the producer. The sticker label had to be affixed to th e packaging if not 
already on the product and be visible to the consumer buying the product. On confidentiality of 
information, INMETRO maintained a strict policy which was consistent with ISO/IEC 17065. On the 
filming and recording requirements, serious c onsideration had been given to comments made in 
the Committee and in public consultation, but his delegation could not disclose at this point if the 
requirement would be excluded from the final regulation. He also stated that the measure would 
be a less bu rdensome approach for producers because products from the same family would 
acquire the same registration number. Finally, Brazil considered that the fast -moving nature of the 
industry justified  the requir ement for  a periodic renewal of certification.  
2.2.3.30   Kore a – Standards and Specifications for Wood Products, G/TBT/N/KOR/563 , 
G/TBT/N/KOR/599 (IMS ID 491)  
2.220.   The representative of the United States  thanked Korea for the bilateral discussion and 
asked whether Korea would reconsider enforcement of the glue and lamina ted timber and  oriented 
strand board standards until a suitable method was in place to allow conformity assessment to be 
conducted in the country of origin. The US appreciated that the Korea Forest Service (KFS) had 
accepted the US Department of Commerce ( DOC) PS 1 standard  for plywood. However, she 
highlighted three outstanding issues: (i) the US requested an update on the adoption of the 
Foreign Q uality Inspection Institute (FQII) Law; (ii) the US encouraged KFS to accept certified 
glulam that used  visual ly graded lumber in its core pursuant to provisions in the Korean glulam 
standard and test data provided that demonstrates that necessary strength properties have been  
met; and (iii) the US encouraged KFS to recognize the US DOC PS 2 sta ndard for oriented strand 
board.  
2.221.   The representative of Canada  appreciated Korea's efforts to work with Canadian trade and 
forestry officials to resolve issues related to a number of forest -product standards . Canada shared 
the concerns expressed by the United States, especial ly regarding oriented strand board. In this 
respect, Canada requested that KFS recognize CSA standard O325 , which was harmonized to the 
US DOC PS 2 standard for oriented strand board . He appreciated Korea's attention to Canada's  
concerns abou t its forest p roduct standards, and looked forward to resolving this issue in the near 
future.  
2.222.   The represen tative of the Republic of Korea , in response to comments regarding the 
designation of FQII, said that Korea n authorities had prepared an " Amendment of  law of 
susta inable use of wood" . However, the Korean National Assembly session had ended in May 2016, 
and the  KFS therefore planned  to resubmit the amendment draft to the  following National 
Assembly session. As soon as the amendment draft was approved, KFS would  initiate the process 
for FQII designation.  With respect to the Korean standard for oriented strand board, he explained 
that it covered not only uses for structural purpose s, but also  general purpose s such as interior or 
furniture manufacturing . Also, like the E U, the Korean standard for oriented strand board  adopt ed G/TBT/M/70  
 
- 45 - 
 
  the quality standard of the  ISO international standard.  The performance standard  for oriented 
strand board adopted by the  US and Canada was different from  the Korean standard . However,  he 
noted that  Korea already amended this regulation regarding the plywood standard to reflect 
comments from the US and Canada for 3-ply structural plywood, since they satisf ied Korea's  
bending strength requirement . Korea was therefore open to discuss outstanding concern s in a 
transparent manner with interested parties . 
2.2.3.31   China - Interim Measures for Quality Management of Commercial Coal, 
G/TBT/N/CHN/1057 (IMS ID 477)  
2.223.   The representative of Australia  thanked China for bilateral discussions on the coal 
standards conformity as sessment, notified as urgent in September 2014 and entered into force on 
January 2015. As concerns continued to exist, Australia asked for a formal written response from 
China on numerous queries raised through the Chinese TBT E nquiry Point and for an indi cation of 
the timing on when Australia could expect a response. China being  Australia's  second largest coal 
export market , the implementation and application of the measure was thus followed with interest 
by Australian industry and exporters. Production fr om Chinese coal mines was estimated to have 
dropped by 4.5 % in 2015, the global drop of imports accounting  for about 32%. Australia was 
committed to being a reliable supplier to China of high quality thermal and metallurgical coal with 
low levels of impuri ties, and supported China in its efforts to improve quality of coal used in the 
energy and industry sectors, but underscored the importance of implementing measures that 
enhance d trade in coal and international competition.  
2.224.   The GlobalC oal standard trading  agreement , on which China based its standards in the 
interim measure, was not recognized as a standard for testing coal quality. Australia asked China 
to explain why it did not use or recognize the relevant internationally recognized and accepted ISO 
standard, ISO 13909 . In addition, she asked China to explain how the GlobalCoal standard coal 
trading agreement applie d to domestic and imported coal.  
2.225.   On conformity assessment  procedures, Australia also urged China to accept test results of 
internationally ac credited facilities  based in  other countries , enabling tests to be undertaken in a 
more expeditious way, reducing duplication costs and preventing delays at point of import where 
test results had to be received prior to unload. Australia requested that China provide an update 
on any improvements to timeframes in testing imported coal and asked what type of interaction 
existed for testing authorities to discuss results obtained in China, whether these results differed 
from results obtained elsewhere, what re view or appeal process existed when Chinese test results 
differed from Australian or other countries' results and , in case of the latter , or when results 
differed between test at different Chinese ports on the same shipment, whether China had given 
conside ration to an independent review of appeal process. Australia raised concerns on how the 
3.6 billion ton nes of Chinese coal were being tested and how China ensured consistency between 
tests on imported and domestic coal. He asked  China to provide details of  authorities that 
undertook domestic testing, to indicate what happened with the results of domestic tests 
undertaken thus far, to explain what happened with domestic coal not meeting the quality criteria 
and how China ensure d testing across all ports into  China by sea, rail and road. Australia looked 
forward to the continued discussion with China on these issues.  
2.226.   The representative of China  said that his delegation had  replied to Members' concern in the 
Committee many times and emphasized that from Januar y 2015, domestic and imported coal 
needed to attain the same standards of Interim Measures for Quality Management of Commercial 
Coal. China took note of Australia's comments raised in the meeting and would study the written 
comments previously submitted an d address them at the next meeting of the Committee .  
2.2.3.32   India - The Stainless Steel Products (Quality Control) Order, 2015, 
G/TBT/N/IND/50 (IMS ID 486)  
2.227.   The representative of the European Union  reiterate d his delegation's previous concerns 
with this measure, and recalled written comments to this notification  sent by the EU on 23 October 
2015.  The notified draft was similar to other certification measures adopted by India for steel 
products, such as the Steel and Steel Products (Quality Control) Order, 2006  (notified as 
G/TBT/N/ IND/32 ). The notified draft  further extend ed the scope of the existing BIS mandatory G/TBT/M/70  
 
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  certification system to three additional  steel products, such as stainless steel plates, sheets and 
strips.  
2.228.   The EU was concerned that these measures could constitute an unnecessary barrier to 
trade.  He recalled  concerns about  the necessity and costs related to BIS mandatory certification 
requirements , and the re -testing by BIS -authoriz ed laboratories of the c overed steel products 
which had  already been tested against relevant international standards.  The EU again ask ed India 
to confirm that the standards referred in the notified draft were equivalent to the relevant 
international standards , and if so, requested that India refer to  those international standa rds in the 
text as well.  Finally, the EU reiterate d that the factory inspections required by the BIS certification 
system  would be of no added value for the EU steel mills which already had  put in place quality 
management system s (QMS)  as defined in ISO 90 01. 
2.229.   The representative of India first addressed concerns about the  necessity of the measure 
and the requirement of re -testing. In this regard, he stated that the BIS (Certification) Regul ations 
1988 require d evidence of conformity of the product to the rel evant Indian Standard through 
testing in a BIS or BIS -recognized laboratory, for the purpose of granting a BIS marks certification 
licenc e. He explained that s amples were drawn for testing in independent laboratories for 
assessing conformity to the relevan t Indian S tandard before granting  a licence. Indian Standards 
specif ied test method s, and the labs recognized by BIS carried  out tests as per the test methods 
and requirements defined in Indian Standards.  With respect to concern s about  the cost of 
certification, India stated  that testing charges for samples were part of an annual marking fee  for 
operating the licence. He submitted that t he cost of BIS certification was reasonable.  
2.230.   Concerning the question of equivalence with international s tandards, India informed 
Members  that the standards referred in Stainless Ste el (Quality Control) Order 2015 (namely, IS 
5522:2014;  IS 6911:1992 ; and IS 15997:2012 ) were  not harmonized with international standards 
because they ha d been developed tak ing into consideration ma nufacturing pr actices followed in 
the Indian m arket.  Moreover, there was no ISO standard equivalent to IS 15997 and  IS 5522. 
However, t he formulation of IS 6911:1992  had drawn upon ISO 683/13:1986, BS 1449 (Part 
2):1983 and AISI  standards . He noted that  IS 6911:1992  was currently under revision , and 
additional  international references were  being considered in the revision  version.  
2.231.   He expressed doubts as to the EU  suggestion that steel mills with ISO 9001 QMS be 
exempt from the requirement of factory inspect ions. India was of the view  that product 
certification was different from QMS certification. A visit to the factory premises , and verification 
and testing in the factory, was a part of the BIS conformity assessment scheme. On the other 
hand, ISO 9001 certi fication d id not cover factory t esting as per Indian Standards.  
2.2.3.33   European Union - Restriction on Polycyclic Aromatic Hydrocarbons (PAHs) in 
Tyres as specified in Anne x XVII of REACH, G/TBT/N/EEC/52 (IMS ID 480)  
2.232.    The representative of China  reiterated its c oncern about test method ISO 21461, 
referenced in Entry 50 of Annex XVII of REACH (1907/2006/EC) stating that it was not suitable for 
conformity assessments related to efforts to restrictions of PAHs, as it was an unusual and indirect 
quantitative method f or the determination of PAHs. GC -MS and HPLC, test  methods specified in 
technical regulations and international standards, were more accurate and more developed . 
According to China, using test method ISO 21461 was unscientific, inappropriate, could  cause 
misleading results and involved  significant costs for tyre manufacturers. China requested the EU to 
provide a scientific rationale for the test method, to conduct a timely review and make revisions 
accordingly.  
2.233.   The representative of the European Union  reiterated that the measure in question had 
been notified under the TBT Agreement on 21 January 2004 (G/TBT/N/EEC/52, so -called REACH 
regulation) and ha d been extensively discussed with WTO Members, economic operators and other 
stakeholders. The EU had been ap plying  the contested test method (ISO 21461), which was part 
of an international standard, since January 2010. The nuclear magnetic resonance spectroscopy, 
needed for this test, was an instrument typically available in specialized laboratories. The EU 
repeated its request for more information on validated chromatograph ic methods to which China 
referred . G/TBT/M/70  
 
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  2.2.3.34   India - Draft Food Safety and Standards (Alcoholic Beverag es Standards) 
Regulations, 2015, G/TBT/N/IND/51  (IMS ID 494)  
2.234.   The representative of the United Stat es, whilst expressing support for India's efforts to 
develop safe and effective standards for regulating alcoholic beverages, remained concerned that 
in a number of areas India had proposed standards that fell outside of widely accepted 
international norms  and standards and that consequently may restrict trade more than necessary 
than required to achieve India's objective. She observed that recently released revisions of the 
draft measures did not take into account comments submitted by the US in February 2 016. 
2.235.   She reiterated concerns regarding the standards set by India on a number of compositional 
limits for which standards did not exist in Codex Alimentarius, for example levels for chemical 
contaminants in alcoholic beverages.  In addition, India had set l imits with regard to pH, carbon 
dioxide, and sugar levels that seemed to pertain to the quality of alcoholic beverages rather than 
the safety thereof. The US requested scientific justification for these limits as well as the specific 
scientific studies bac king them up, as appropriate.  
2.236.   Her delegation requested an update on whether India would include a number of additives 
commonly used in distilled spirits manufacturing in the list of permitted additives and in particular 
requested a response to the specifi c additives authorization requests included in US comments on 
G/SPS/N/IND/108 and G/TBT/N/IND/51 (identical to G/SPS/N/IND/119), submitted the previous 
year. The US was also concerned with the labelling requirements associated with this standard and 
asked India to clarify whether stickers would be allowed to be placed on alcoholic beverages at 
port before these items passed through customs. She recalled the many other important issues 
and concerns noted in her delegation's comments of 1 February, including irregular serving size 
measurement, 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 concerning, and asked when  India would provide a response thereto.  
2.237.   In conclusion, she stated that the US would welcome the opportunity to discuss the 
process India had followed in creating this standard and asked whether India had considered 
existing regulations of other countries and international standards on alcoholic beverages. In this 
regard, her delegation would welcome dialogue to explain its own regulations and the rationale 
behind their formation. Asking when India would implement this measure, she urged that an 
adequate tr ansition period be provided to allow industr y to comply with this measure. Finally, she 
asked whether the revised draft Alcoholic Beverage Standard would be notified to the WTO.  
2.238.    The representative of Mexico  expressed its concerns with respect to India's Proposed Draft 
Food Safety and Standards – Alcoholic Beverage Standards – Regulations, 2015, notified to 
Members in document G/TBT/N/IND/51 on 1  December  2015 and published on 29  October  2015 
on the website of the Food Safety and Standards Authority  (FSSAI ) and on which Mexico had 
formally submitted comments on 18  December  2015, during the public consultation on the 
measure. Whilst grateful for a recent bilateral meeting, her delegation reiterated its concerns, 
which centred on the definition of Tequila in section 2.6 "Tequila" of the FSSAI regulations and, in 
particular, its subsections 2.6.1. to 2.6.6. Mexico considered that both the domestic production of 
Tequila and all Tequila exports were highly regulated and monitored, on the basis of both the 
applica ble Mexican technical regulations and the provisions of the Designation of Origin of Tequila 
concerning the regions of production of this distinctive drink. Mexico therefore urged the relevant 
Indian authority to take into consideration the definition of T equila contained in NOM -006, since 
until this definition was aligned on Mexican regulations, her delegation feared there would be 
obstacles to the entry of this type of product into India. Finally, Mexico requested an update from 
India on the status of the  review of their comments submitted during the public consultation on 
the measure and the holding of a video -conference with the technical services responsible for 
drawing up the measure on food safety and alcoholic beverages standards in India, in order t o 
settle on suitable language for the definition of Tequila in the Indian measure, which would make it 
possible to protect the Designation of Origin Tequila and ensure access to the Indian market for 
this type of product.  
2.239.    The representative of Canada  requested an update from India on a number of items 
discussed at the previous meeting including the status of the regulation, as well as a timeline for a 
further list of additives in alignment with OIV standards which had been approved by the Indian 
food autho rity and which, according to India, would be notified to the WTO in due course.  He also G/TBT/M/70  
 
- 48 - 
 
  referred to his delegation's previous comments concerning the draft regulation's maximum alcohol 
content limits for whiskies and requested an update on this issue.  
2.240.   The representative of the European Union  noted that India had been interested in the EU 
position during the preparation of the draft measure and thanked India for the bilateral meeting 
held at the margins of the ongoing TBT Committee. She recalled concerns ra ised at the June 2016 
Committee meeting11 as well as detailed written comments on the notified draft in January 2016. 
She expressed concern that India had not notified a new draft to the Official Gazette (Draft Food 
Safety and Standards, Alcoholic Beverages  Standards, 2016), published by the Food Safety and 
Standards Authority of India (FSSAI) on 6 September 2016 and reminded India of the 
transparency obligations contained in the TBT Agreement. In addition, the list of food additives 
permitted in alcoholic b everages had been recently adopted by the competent Indian authorities 
and notified to the WTO on 22 September 2016 , but only via the WTO -SPS notification system, 
and not TBT. She therefore reminded India of its obli gation to notify the new draft r egulatio ns 
under the TBT Agreement and to allow a reasonable time for comments befo re the entry into force 
of the r egulation.  
2.241.   Regarding  the new draft r egulations, the EU underlined that most of its concerns 
expressed in its comments sent in January 2016 still rem ained. In particular, her delegation 
reiterated its concerns regarding a number of inconsistencies between the new text and current 
international practices (i.e. the oenological practices and definitions as set by the OIV and Codex) 
and therefore urged Ind ia to align itself with them in order to be fully in line with Article 2.4 of the 
TBT Agreement. Finally, the EU urged India to provide a reasonable transition period for 
manufacturers to comply with the new provisions and to allow the sale of products alr eady present 
on the Indian market until exhaustion of stocks.  
2.242.    The representative of Switzerland  asked for an update on the extent of the scope of 
validity of India's labelling standards. He also reiterated his delegation's view that by accepting 
elements that were simple translations of internationally standardized labelling elements by means 
of supplementary labels, i.e. stickers, India could address its issues regarding consumer 
information.  
2.243.   The representative of Guatemala  reiterated its systemic interes t in this issue.  
2.244.    The representative of Japan  voiced support for the concerns raised by the US, Mexico, 
Canada and the EU. He requested an update on the status of the revision of the regulations and a 
timeline for adoption in light of India's statement at the previous meeting that the measure would 
probably be finalized within the year, after due consideration of comments by all Members and 
stakeholders.  
2.245.   The representative of South Africa  welcomed bilateral discussions held on this trade 
concern and encour aged India to follow the well -respected Codex and OIV standards in developing 
their standard.  
2.246.   The representative of New Zealand  reiterated her  belief that wine should be seen as a 
single ingredient product, and noted that numerically -based labelling requir ements, such as the 
numerical definitions of wine categories, failed to take into account seasonal and regional 
variances in wine production, thereby constituting an unnecessary burden on wine producers. In 
this light, her delegation looked forward to hear ing how India would respond to the concerns of 
wine producers and importers.  She also requested information on how comments made by 
Members had been taken into account and when an updated version of the regulation would be 
notified to the TBT Committee.  
2.247.    The representative of Australia  reiterated his delegation's previously -raised concerns, in 
particular that India had not fulfilled its notifications requirements . Australia also noted India's  
steps to adopt  certain wine additives consistent with OIV, of whi ch both Australia and India were 
members , as a positive step . 
                                                
11 G/TBT/M /69, paras 3.309 -3.310.  G/TBT/M/70  
 
- 49 - 
 
  2.248.   The representative of India recalled that the Draft Food Safety and Standards (Alcoholic 
Beverages Standards) Regulation, 2015 had been notified via G/SPS/N/IND/119 and 
G/TBT/N/IND/51, both with  a 60-day comment period. After consideration of the comments and 
feedback from Members and other stakeholders, the Food Safety and Standards Authority of India 
(FSSAI) had published, on 5 September 2016, another draft regulation, namely the Draft Food 
Safety and Standards (Alcoholic Beverages Standards) Regulation, 2016, which had been uploaded 
onto the FSSAI website on 9 September 2016. The matter was presently under consideration of 
the authority, and the comments received from WTO Members as well as dom estic stakeholders 
were being examined. He went on to confirm that a transition period would be provided for 
industry to comply with these measures once the matter was finalized, in line with suggestions by 
several delegations.  
2.249.   On the issue raised that th e revised draft regulation of September 2016 should also be 
notified to the WTO, India stated that it had been published on the website of the Food Authority, 
seeking comments of stakeholders, in compliance with specific provisions of the FSSAI Act, and  
that regarding the notification requirements of the TBT Agreement, the draft measure had already 
been notified once in December 2015. On the issue raised by some Members that the draft 
regulations may deviate from internationally agreed norms, he said that t he Indian authorities 
believed that there were no Codex standards prescribed for alcoholic beverages, except for the 
provisions on additives.  
2.250.   Regarding additives, he recalled that India had notified its draft regulations on food 
additives in G/SPS/N/IND/1 08, wherein the provision of additives for the category o f wine had  
been adopted from Codex GSFA (General Standard for Food Additives). Subsequently, another 
notification had been  filed in the SPS Committee (G/SPS/N/IND/157) seeking comments from 
Members i n the matter of additional additives, enzymes and processing aids for use in alcoho lic 
beverages including alcohol -free and low -alcoholic counterparts. Based on the suggestions 
received from Members, a further list of additives in alignment with OIV standa rds had  been 
approved by the Food Authority. Accordingly, the Draft Food Safety and Standards (Food Products 
Standards and Food Additives)  Amendment Regulations, 2016 had  been uploaded on the FSSAI 
website on 1 November 2016, seeking comments and suggestio ns of persons likely to be affected  
2.2.3.35   China - Formula Registration Regulation fo r Infant and Follow -up Formula,  
G/TBT/N/CHN/1165 (IMS ID  493)  
2.251.   The representative of the European Union  share d the objective of China to ensure the 
highest level of protection in the area of infant and follow -up formula.  However, as conveyed in 
written comments and during the latest TBT Committee  meeting , the EU was very concerned 
about some aspects of the draft measure . In particular, the limitation of each manufac turing 
company t o a maximum of nine registered recipes within three  product lines  would have serious 
and unnecessarily negative trade impact on the current exports from the EU to China. Different 
major brands of infant formula currently relied  on a lesser number of produc tion partners for the 
manufacture of their products.  It was estimated that, without modification of this restriction, the 
number of brands on the Chinese market would be reduced by 80%. The EU did not find a 
justification to this limitation, neither on the  basis of food safety nor on the basis of any other 
legitimate objective, and therefore the EU kindly requested that it be  remove d; in any case it 
needed to be possible for the recipe owner to be the applicant for registration. The EU also 
consider ed that the new registration and approval procedure require d appropriate time for 
transition from the current system in order to avoid disruption of trade, such as a period of 18 
months.  It was noted that at the latest Committee meeting, China had  indicated that a  slightly 
revised CFDA measure, without modification of the limitation of the number of recipes for 
manufacturing companies, would become applicable on 1  October 2016.  The EU request ed China 
to confirm the status of the measure  and to provide inform ation a bout any additional transition 
measures.  
2.252.   The representative of the United States  sought to ensure that trade would  not be 
unnecessarily disrupted as a result of Decree 26, and asked for more clarification of the measure, 
its basis, and the process China foresaw  with respect to its development and implementation.  In 
particular, the United States request ed that China explain the basis for limiting the number of 
infant formula products that companies could  place on the market.  Had CFDA determined any 
health or  food safety risk that would be mitigated by limiting the registration of infant formula ? If 
so, on what basis and evidence had that determination been made?  In particular it would be G/TBT/M/70  
 
- 50 - 
 
  helpful if China could address why  the limitation was necessary if CFDA determine d the specific 
infant formulas registered with it were determined to be safe and effective.  The US representative 
also noted that US infant formula production facilities already ha d to comply with CNCA inspection 
requirements under Decree 145. So, she asked, u nder what circumstances would additional 
inspections need to be done by CFDA?  Could the Government of China please clarify how this 
regulation and Decree 145 would operate together?  
2.253.   The representative of the Republic of Korea  express ed his del egation's concerns about  
China's Registration Regulation for Infant and Follow -up Formula which had been  notified to the 
WTO TBT Committee on 7 July 2016 under G/TBT/N/CHN/1165.  CFDA had announced on 6 June 
2016 that the Regulation would go into effect 1 October  2016. At the previous Committee meeting, 
Korea had asked China to provide a grace period  and China had decided on 30 September  2016 to 
give a 15 -month grace period on one of the sub -regulations. Korea also appreciate d the transition 
period to allow products manufactured in China or imported to China before 1 January  2018 to be 
distributed in the Chinese market until production expiration dates.   
2.254.   While the Korean Government fully underst ood the need for strict control of infant formula 
products , conce rns remained regarding duplication of site inspection by the CNCA (Certification 
and Accreditation Administration of the People's Republic of China) and the CFDA.  On 
12 August  2016, CFDA had published the new draft regulation for formula registration of in fant 
formula milk powder for public comment. The draft regulation had included requirements on 
registration dossier and on -site inspection. Korea had submitted its opinion and suggestions. 
However, the requirements on registration dossier and on -site inspe ction had not  yet been notified 
to the WTO TBT Committee.  Korea requested that China notify the draft regulation to the WTO TBT 
Committee so that stakeholders could  provide input  in order to reduce business risks associated 
with the Regulation in a predict able and transparent manner.  Korea also asked China not to 
duplicate registration process for Korean formula recipes and establishments ; it was hoped that 
China would exempt the Korean establishments which had already been assessed by and 
registered at the  CNCA in 2014 from site inspection . China was asked to simplify the process to 
register products already being exported to China.   
2.255.   The representative of Japan  share d the concern raised by Korea, the US and the EU.  As 
the EU had pointed out in previous meet ing, this measure would drastically reduce the number of 
brands on the Chinese market.  Japan did not see any justification for the limitation on the basis of 
legitimate objectives.  China was hence asked to reconsider the measure, also taking into account 
the concerns raised by other Members . 
2.256.   The representative of New Zealand  noted that China was a major export market for New 
Zealand, including for infant formula. New Zealand industry ha d undertaken a lot of work to 
prepare for the new regulatory environment  and, as the application process continue d to be 
developed, New Zealand hoped that this would result in simplification.  As applications were not yet 
being accepted , China was invited to consider extending the transition period.  New Zealand w ould 
continue t o work with CFDA to ensure a smooth transition to the new regulatory environment for 
imported products.  
2.257.   The representative of China  said that his delegation attache d great importance to the 
safety of infant formula milk powder quality. Infant formula milk powder ha d always been the most 
stringently regulated food in China. The situation in China was quite unique : there was great 
market demand and rapid development, while at the same time  there were problems on the 
market such as consumer confusion caused by  too many brands and formula s. The regulation at 
issue would further regulate China 's market to ensure high quality of milk powder  and this would 
be beneficial for relevant enterprises, including foreign companies .  
2.258.   It was noted that b efore drafting this r egulation, China had  carried out research in infant 
formula milk powder. Theoretically, infant formula milk powder should only be a nutritional 
supplement to breastfeeding. Therefore, the composition of infant formula milk powder needed to  
be similar to br east milk and there could not be too many recipes . Data from research showed  that 
large foreign infant formula milk powder manufacture rs had, normally,  no more than three brands 
in production and sale . To address Members ' concerns regarding  on-site inspect ion, China wished 
to clarify that the on -site inspection mainly focuse d on the R&D data of milk powder formulas and 
manufacturer 's capacity to turn formu las into production. The focus of the on -site inspection 
differed from the past one. China  had also taken note of M embers ' concerns about possible G/TBT/M/70  
 
- 51 - 
 
  duplicative inspections ; such duplication would be avoid ed through more internal communication.  
The representative of China stressed that the regulation applie d in a non -discriminatory manner to 
both domestic and  foreign manufactures.  
2.2.3.36   Indonesia — Halal Product Assurance Law No. 33 of 2014  (IMS ID 502)  
2.259.   The representative of the United States  thanked Indonesia for the bilateral meetings that 
had taken place. The US wanted to work with Indonesia to ensure the law was  implemented so as 
to achieve the objective of ensuring that consumers knew whether products were halal without 
creating unnecessary barriers to trade. The US strongly supported providing consumers with the 
necessary information to make informed decisions but remained concerned on the requirement 
that both halal and non -halal products be labelled as such as this could cause confusion for 
consumers and be costly and challenging to implement. On the new registration requirement for 
foreign halal certificates,  there were concerns that the requirements were cumbersome and 
duplicative and it was unclear what the registration requirements were for local products. She 
requested that Indonesia modify the registration requirements to reflect that foreign halal agenci es 
issuing halal certificates for imported goods had already been verified by BPJPH . She further 
requested an update on the official status of the revision of the September draft that the Ministry 
of Religious Affairs had prepared, including the timeline r egarding the issuance of the final 
regulations. The US again requested that the draft implementing regulations be notified to the 
WTO prior to being finalized so as to allow time for comments from stakeholders and for those 
comments to be taken into accoun t. Finally she requested clarification on where the official draft 
would be made available and how it would be disseminated.  
2.260.   The representative of the European Union  expressed concern with Law 33 of September 
2014 which had a very broad scope, affecting, inter alia , food and beverages, pharmaceuticals, 
chemical and biological products, all consumer goods and cosmetics, as well as related services. It 
required mandatory halal certification and labelling for the products within its scope in order to be 
placed  on the Indonesian market. In particular, Article 4 of the law provided that products that 
entered, circulated and traded in the territory of Indonesi a must be Halal certified. The l aw would 
be implemented gradually in three stages and fully enforced as fr om 2019. It appeared that, f rom 
then on, non -halal products (not certified and l abelled in accordance with the l aw) could not be 
placed on the Indonesian market. This represented a total ban on the importation of non -Halal 
products. The EU invited Indonesi a to clarify whether non -Halal products could be placed on the 
Indonesian market and whether they would be subject to mandatory labelling or any other 
restrictio n for international trade. The l aw did not specify the requirements that had to be fulfilled 
by exporters, and certain halal requirements had already been set out in separate regulations (i.e., 
for imports of carcasses and meat). The EU considered that the lack of transparency on 
implementing rules and the fragmented approach created uncertainty as to which requirements 
were applicable at any point in time.   
2.261.   According to recent information received by the EU, a draft implementing regulation was 
being developed , but had not yet been adopted. The EU asked for an update on any developments 
in this resp ect and on the time frame for the adoption of the said implementing regulation. She 
reminded Indonesia that measures should not be more trade restrictive than necessary and  that 
the non -discrimination principle should be taken into account, as well as tran sparency provisions. 
She further noted the EU's request that in accordance with Article 2.9 of the TBT Agreement, 
Indonesia notify the law, and any subsequent implementing rules, while still in draft form , allowing 
reasonable time for Members' comments to be taken into consideration. Additionally, as laid out in 
Article 2.12, Indonesia should allow for a reasonable interval of time between the publication and 
the enforcement of the measure, in order to allow time for producers in exporting Members to 
adapt their products or methods of production to Indonesian requirements.  
2.262.   The representative of Australia  raised concerns regarding the possible trade restrictiveness 
of the proposed measures. Australia had on -going discussions with Indonesia and recognized the  
importance of halal product assurance. She welcomed the delay in introducing the regulations until 
November 2019 and, like other delegations, reminded Indonesia of their transparency obligations 
under the TBT Agreement. On the content, status of implement ation and the expected consultation 
process, she put the fol lowing questions to Indonesia: w hat were the standards for halal products 
that were not subject to certification under the current arrangement, such as leather belts? What 
were the labelling requi rements for non -halal products? Could Indonesia explain the objective it 
sought to achieve through the labelling of non -halal products? Would the relevant halal registration G/TBT/M/70  
 
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  authority grant mutual recognition to halal product certificates issued by foreign  halal agencies, 
and what was the process for foreign agencies to be recognized? Finally Australia reiterated their 
support for measures that achieve legitimate policy objectives but it was important to ensure they 
were not more burdensome than necessary a nd could result in cost increases for both producers 
and consumers.  
2.263.   The representative of New Zealand  said her delegation was closely following this regulation 
and like others requested that Indonesia provide an update on the development of the draft and 
that it be notified to the WTO.  
2.264.   The representative of Indonesia  referred the Committee to the minutes of previous 
meetings12 where answers had been provided to Members' questions. Indonesia would notify the 
Committee with any updates of the law.  
2.2.3.37   Russian Fede ration — Rules of cement certification G/TBT/N/RUS/48, 
G/TBT/N/RUS/49 (IMS ID 497)  
2.265.   The representative of the European Union  informed the Committee that t he EU ha d already 
raised this issue during previous meetings of the TBT Committee  and that  following th ose meetings  
the Russian Federation had notified, on 8 March 2016 , the Gov ernment Resolution No. 930 of 
3 September 2015 "On A mendments of the Single List of Goods Subject to Mandatory 
Certification" adding cement to the list of goods subject to mandatory certification  
(G/TBT/N/RUS/48). Russia had also notified the Order of Federal Agency for Technical Regulation 
(Rosstandart) No. 1 -st of 11 January 2016 "Conformity assessment. Rules of cement certification" 
(GOST standard 56836 -2016), on 12 April 2016  (G/TBT/N/RUS/49 ), setting out the relevant rules 
for cement certification.  However, both measures had already  been adopted and were in force at  
the time of their notification . The EU therefore reiterated its request to  Russia to suspend the 
measures and re -notify them to the WTO  at a draft stage, allowing Members' comments to be 
taken into account.  On the content of the measures, the EU raised several concerns . 
2.266.   Section 8.2 of the notified GOST  standard provided that for imports from third countries 
the certific ation body should conduct additional inspection controls of each batch of cement. This 
included sampling at the border, as well as the testing and control of all characteristics set out in 
the standard according to which the certificate of conformity had b een granted.  On the basis of the 
results, the certification body had to make a decision as to whether to confirm, suspend or 
terminate the certificate of conformity. It was the EU's understanding that this provision set a 
requirement for "additional inspec tion control" of each cement batch arriving in Russia from third 
countries, including sampling at the border, testing and checking according to the standard. The 
EU asked Russia for the reasons and justification for such a requirement and underlined that t he 
presence of additional requirements for conformity assessment affecting only imported products 
might contravene both Articles 5.1.1 and 5.1.2 of the TBT Agreement.  
2.267.   In relation to the additional inspection controls, the EU raised further questions: (i) what 
was the meaning of shipment (whether it would mean each wagon, whole train or yearly 
production); (ii) by whom and how would these samples be taken from imported cement; (iii) how 
would the tests be performed, their length and whe ther after sampling a nd testing  the imported 
cement would be allowed to proceed further to the unloading point and/or to the end consumer, or 
whether the imported cement would be held at the border until the results of the testing were 
known and a decision on the certificate o f conformity was taken (wh ich the EU understood to take 
on average 28 days).  
2.268.   The EU again requested clarification on the following issues. Firstly, confirmation that the 
certificates issued by a certification body had to be registered with Rossacreditatio n. If this was the 
case, Russia should clarify why such a registration might be refused or delayed. Secondly, the EU 
asked Russia to clarify whether the certification bodies had to be registered with, and empowered 
by, Rossacreditation to issue certificate s of conformity under the notified GOST standard.  The EU 
understood  that many EU manufacturers were granted certificates during  the summer, which were 
withdrawn after an audit by Rossaccreditation . What were the reasons for such withdrawals ? 
                                                
12 G/TBT/ W/443 and G/TBT/M/69 para s 3.325 -3.327.  G/TBT/M/70  
 
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  2.269.   The representa tive of  Ukraine  echoed the position of the European Union. Her delegation 
considered that the provisions of cement certification placed  on domestic and foreign suppliers  to 
be unequal. She asked Russia to take into consideration these concerns so as to ens ure that the 
notified measures were in line with the requirements of international practice and did  not create 
unnecessary barriers to trade.  
2.270.   The representative of the Russian Federation  recalled tha t the Government Resolution 
No. 930 of 9 September "On A mendments to the Single List of Goods Subject to Mandatory 
Certification" had added cement to the above -mentioned list. He further stated that the resolution 
had been notified to the WTO. The relevant new standard GOST -R was adopted by the Federal 
Agency f or Technical Regulation and Metrology and was also notified to the WTO. The necessity for 
inclusion of cement in the list of goods subject to mandatory certification had been determined by 
a sharp decrease in cement quality in Russia and urgent problems of  safety, health and 
environmental protection. In particular, state supervision at construction sites revealed serious 
problems caused by low -quality cement, with four main issues: (i) hazardous content in cement of 
carcinogenic hexavalent chromium (CrVI); (ii) high alkali content in cement leading to early -age 
cracking in concrete and negative impact on the metal support structure; (iii) low compressive 
strength; and (iv) insufficient frost resistance. These urgent problems constituted a danger to life 
and health directly because of the content of a carcinogen and indirectly due to the quality and 
reliability deterioration in construction. The lists of certification bodies and of issued certificates 
were available on the website of the Federal Accreditation Body. He noted that since 8 March 2016 
294 certificates for different types of cement had so far been issued, including 51 certificates for 
cement imported to Russia from WTO Members. He said that the list of documents and tests 
required to obtain a certif icate for cement and the GOST -R requirements were equal for all 
manufacturers. Regarding inspection control for cement, the GOS T-R provided for two forms: 
(i) inspection control at a production site; and (ii) inspection control of the products on the borde r. 
While inspection control at a production site presumed a complex control of production conducted 
once every six months and with additional unscheduled inspections, the control of products was a 
simpler and less costly procedure. Russia had taken note of  concerns raised and would continue to 
work with interested Members on this matter.   
2.2.3.38   United Arab Emirates — Control scheme to restrict the use of hazardous 
materials in electronic and electrical devices (IMS ID 496)  
2.271.   The representative of the European Union  thanked the United Arab Emirates (UAE) for 
notification of this measure, and said that her delegation shared the UAE's objective of protect ing 
human health and the environment. Nonetheless, she raised a number of  issues of concern with 
the measure. First,  regarding the lists of exemptions in Annexes 3 and 4 of the notified draft, the 
EU noted that they did  not include many relevant exemptions included in similar regulations on the 
restriction of the use of certain hazardous substances in electrical  and ele ctronic 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 benzy l phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl 
phthalate (DIBP) , would be forbidden without appropriate transition, which would certainly disrupt 
trade in this area.  
2.272.   Second , regarding the enforcement of the restrictions laid down by the notified  draft, the 
EU noted that Article 4.1 was unclear and did not specify whether the restrictions listed in Annex 2 
only applied when the electrical and electronic devices were placed on the market for the first time 
or also to the following marketing stages.  Therefore, the EU requested the UAE authorities to 
clarify whether and how the restrictions listed in Annex 2 applied to electrical and electronic 
equipment already on the market.  Third, she stated that  re-use, refurbishment and extension of 
lifetime of p roducts already on the market were beneficial for the protection of the environment. 
Spare parts therefore needed to be available. In this respect, the EU asked the UAE authorities 
whether exceptions for the repair of products placed on the market before t he application of the 
notified draft could be considered.  Fourth, the EU highlighted that in Article 9.4 of the notified draft 
the list of exemptions in Annexes 3 and 4 related to "products", instead of "applications in a 
product", whereas the headings of Annexes 3 a nd 4 referred to "applications". In this respect, the 
EU asked the Emirati authorities  to explain  the exact scope of application of the exemptions at 
hand.  Fifth, regarding the procedure for conformity assessment, the notified draft referred in 
Article 5 to "Model A" and to a submission to the Emirates Authority for Standardization and 
Metrology (ESMA); in Article 6 to registration; and in Article 8 to an application.  Clarification was G/TBT/M/70  
 
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  sought on the exact procedure for the placing on the market o f 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.  
2.273.   The EU representative noted that it  was not possible for the UAE to provide a response to 
EU comments at the two previous TBT Committee meetings. In the course of bilateral contacts, the 
UAE indicat ed that EU comments would be given full consideration. However, to date no amended 
draft measure ha d been made availabl e. The EU sincerely hope d that the UAE could  provide a 
response to its comments, and kindly request ed an update on the status of the measure.  
2.274.   The Chairperson  took note of the EU's statement and asked that their concerns be brought 
to the attention of the U AE. 
2.2.3.39   Thailand — Milk Code - Draft Act on Controlling to the Marketing Promotion on 
Food for Infant and Young Children and Other Related Products BE ( IMS ID 503)  
2.275.   The representative of the United States , whilst strongly supporting  the public health 
objective  of promoting  breast feeding, expressed continued concern  regarding Thailand's proposed 
measure. Her delegation was of the understanding that a new draft of the  measure would  be 
notified  and requested a timeframe for this notification.  She asked how the re vised draft, 
"Marketing Control on Food for Infants and Young Children Act ", would interact with the Thai Food 
Law and the Thai Food Label ling Regulation and whether  either of these measures would need to 
be revised in order to e nforce the Marketing Contro l Act. Recalling the various  Codex standards 
relevant to this measure, including the Standard on Infant Formula and Formulas for Special 
Medical Purposes Intended for Infants, Standard on Follow -up Formula, Canned Baby Foods, and 
Processed Cereal -based Foo ds for Infants and Young Children, as well as the Codex Guidelines for 
Nutrition and Health Claims, her delegation asked Thailand how it had  considered these standards 
and any deviations therefrom  in certain areas.   
2.276.   Regarding  the un-notified draft entitled  "Draft Marketing Control on Food for I nfants and 
Young Children Act B E", the US asked Thailand to  clarify if they we re defining suppl ementary or 
complementary foods.  She noted that Section 15.2 in the un -notified draft stated that  importers 
must provide w arnings against inappropriate preparation or use of the Food for Infants and Young 
Children  and in this regard asked what inappropriate use wa s, and what type s of warnings would 
be required. In particular, the US  was concerned that the new draft did not ap pear to take into 
account the Codex Guidelines for Nutrition and Health Claims, although resolution WHA 63.23 on 
Infant and Young Child Nutrition, noted in  the draft Thai Code, referenced  the Codex.  Thailand was 
asked to explain how the provisions regardin g nutrition and health claims reflect ed the Codex 
Guidelines.   
2.277.   The US reiterated  that the WHO 's Guidance on Ending the Inappropriate Promotion of 
Foods for Infants and Young Children was not an international standard according to the criteri a 
established b y this Committee and asked whether Thailand also recognize d this fact. She reminded 
Members that in the US , adherenc e to the application of the WHO' s International Code of 
Marketing of Breast -Milk Substitutes was voluntary, and complemented by simil ar code s developed 
by leading US  medical professional s ocieties on the marketing of tho se products.  Her delegation 
expressed hope for deeper technical engagement with Thailand on how to achieve its health 
objectives without unnecessarily impacting trade in produc ts appropriate for infants and young 
children  and requested that a reasonable interval for implementation be provided after notification 
of this measure  to the TBT Committee.  
2.278.    The representative of the European Union  joined the US in its interest in this measure and 
thanked Thailand for the reply to written comments. She reminded the Thai authorities of the need 
to ensure that the draft Milk Code was aligned with relevant international standards and therefore 
the need to take into consideration the ongoing  revision taking place within the Codex Alimentarius 
of the Standard on Follow -up Formula. She also recalled that, a s stated in Article 2.2 of the TBT 
Agreement, the Thai draft Milk Code should not be more trade restrictive than necessary. Further, 
and i n accordance with Article 2.12 of the TBT Agreement, Thailand was urged to allow for a 
reasonable interval of time between the publication and enforcement of the measure, in order to 
allow time for producers in exporting Members to adapt their products or me thods of production to 
the Thai requirements. She noted that her delegation would be following closely the developments G/TBT/M/70  
 
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  on the draft, in order to ensure that its concerns were taken into account , and looked forward to 
receiving  information on the timing fo r its adoption . 
2.279.   The representative of Australia , whilst recognizing Thailand's right to take measures to 
address a legitimate public health concern, said that as a supplier of high quality dairy products to 
Thailand, his delegation encouraged them to imple ment standards for the marketing of food for 
infants and young children in a manner that was as trade facilitating as possible. His delegation 
supported transparent and flexible implementation of regulations to minimize disruptions to trade 
and which would  provide opportunities to allow traders to comply with new regulations.  
2.280.   The representative of New Zealand  said that her delegation was of the understanding that 
the draft legislation had been revised and requested that the revised draft be promulgated to g ive 
Members adequate opportunity to comment. Recalling New Zealand's continued concerns about 
the intended application of the draft legislation and its potential impact on trade, she said whilst 
the draft regulation pert ained to infant formula, follow -up formula and growing up milk, her 
delegation sought clarification on the application of the draft regulation to other food products 
consumed by young children defined in the act as between 12 months and 3 years. Additionally, 
clarification was sought on the product labelling restrictions for food products covered by the draft 
legislation.  
2.281.    The representative of Thailand  reported that c omments submitted previously from 
Members had been  taken into account in the revision of the draft by the Ministry of Public H ealth 
and ensured continued involvement of stakeholders , the provision of Mem bers with sufficient 
opportunity to comment on the draft  as well as a sufficient transition period before 
implementation. In response to specific concerns, he confirmed that Thail and stood by Codex for 
relevant product s. However, for sales promotion not covered by  Codex, Thailand used other 
international standards and relevant documents.  Second ly, he explained that the draft Milk Code 
Act had been  developed with strict observance o f Articles 2.2 -2.6 of the TBT Agreement  and in line 
with the international code of marketing of breast milk substitutes and relevant documents.  
Thirdly, he explained that it wa s necessary to regulate marketing promotion of breast -milk 
substitutes for children up to the age of three  years  given evidence  showing that marketing 
promotion of milk products for children of 12 months and above was erroneously  used for children 
of a younger age.  Fourth ly, he stated that the revised draft of the Milk Code did not co ntain a 
section on labelling , as suggested  by M embers.  Lastly, he welcome d the deeper technical 
involvement of experts from M embers in order to improve their practices.  
2.2.3.40   Egypt — Manufacturer Registration System (Decree No. 43/2016 and Decree 
No. 992/2015) G/TBT/N/EGY/114 and G/TBT/N/EGY/115  (IMS ID 505)  
2.282.   The representative of Turkey  reiterated its concerns on Egypt's Decree No. 43/2016 
regarding the amendment of the rules organizing the Registration of the Factories Qualified to 
Export Products to Egypt. Tur key considered that the requirements of Egypt's registration system 
were burdensome and created unnecessary obstacles to international trade and were thus 
inconsistent with Article 5.1.2 of the TBT Agreement which stated that conformity assessment 
procedur es (CAP) should not be more strict, or be applied more strictly, than necessary to give the 
importing Member adequate confidence that products conformed with the applicable technical 
regulations or standards, taking account of the risks non -conformity woul d create. Turkey 
remained of the view that the objective behind the registration system was not well defined, that 
products selected for registration purposes did not share common characteristics or belong to 
certain clusters, and above all that required d ocumentation did not provide information or ensure 
the quality and safety of the products. It was also unclear whether equivalent documents, notably 
quality certificates, were required for Egyptian companies.  
2.283.   She recalled that during the previous Committee  meeting Egypt had explained that it had 
provided a number of facilitating measures including the consideration of registered companies in 
GOEIC, according to Article 94 of Ministerial Decree No. 770/2005, and its amendments issuing the 
Executive Regulatio n to Implement the Import and Export Law "White List", as meeting the 
requirements of Ministerial Decree No. 43/2016. Her delegation expressed disappointment that 
apparently even this measure was no longer in place. Turkey understood that Annex 3 of 
Minist erial Decree No. 770/2005 had been enlarged by Ministerial Decree No. 961/2012. Moreover, 
the scope of the product list had been widened with the Ministerial Decree No.  991/2015. Decrees 
961/2012 and 991/2015 conveyed alternatives for importing the product s listed therein, one of G/TBT/M/70  
 
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  which was the registration of economic operators to GOEIC to be included in the Visual Inspection -
White List, meaning that most products subject to White List overlapped with products in Decree 
No. 43/2016. Turkey deemed this to be  a duplication of product implementation since there was 
already a registration system or pre -shipment inspection in place and questioned the purpose and 
necessity behind establishing a second registration system that would be costly for economic 
operators . Notwithstanding Egypt's statement that White List required producers to provide 
document ation proving that production was  carried out according to one of the relevant Egyptian 
standards, Turkey urged Egypt to find a less trade -restrictive measure than du plication of an 
already established registration system.  
2.284.   Turkey considered that the implementation process also resulted in obstacles to trade as 
the preparation of the large number of documents necessitated long and varying legalizing, 
translating and ap proval procedures, some of which at significant cost and loss of time which 
would impact negatively on the competitiveness in the Egyptian market. Moreover, she highlighted 
that the practicalities of application for registration had not been clarified. It was challenging to 
obtain information about the companies that had completed the registration procedure, since the 
list of applicant companies was not provided by the Egyptian authorities or made publicly 
available. Companies who had already completed the application procedure had been waiting a 
long time without receiving feedback on the status of their application. These difficulties made the 
system much more burdensome for economic operators in terms of time and high costs and led 
Turkey to deem that imp lementation was not transparent.  
2.285.   In response to an invitation from Egypt in the margins of the previous Committee meeting, 
Turkey had transferred the list of companies still awaiting news of their registration applications to 
the Egyptian authorities thro ugh various official channels. However, despite Egypt's assurance that 
manufacturing plants and companies owning trademarks were duly informed of their registration, 
all formal requests by Turkish authorities on the status of registrations had remained for  over four 
months. It was Turkey's view that the registration process, claimed as simple by Egypt, took at 
least five to six months and was therefore a burden on economic operators. On the issue of 
validity of submitted documents contained in Article 2, pa ragraph 3, of Decree No. 43/2016, Egypt 
had stated that the validity of documents was subject to objective visual and material evidence. In 
this regard, as most of the required documents were subject to Turkish Commercial Law, Turkey 
requested further info rmation as to what kind of company or factory inspection would be carried 
out. 
2.286.   In conclusion, Turkey remained of the view that the manufacturer registration system 
constituted a genuine hindrance to market access and therefore requested Egypt to explore le ss 
trade -restrictive alternatives and to bring its legislation and implementation in compliance with the 
principles and rules of the WTO and TBT Agreement.  
2.287.   The representative of the European Union  thanked Egypt for the bilateral meeting held in 
the margin s of the TBT Committee. She reiterated its concerns expressed in written comments to 
Egypt, to which it had already received replies, in particular with regard to the entry into force of 
the legislation. The EU urged Egypt to suspend the application of the  measures, to review them in 
light of the principles and obligations laid down in WTO law, and to re -notify them under the TBT 
Agreement. In addition, the EU was concerned by the possible duplication of procedures and the 
lack of clarity of the requirement s to be fulfilled by European economic operators. She noted that 
the application of the Egyptian decrees was currently creating unnecessary obstacles to trade. 
Industry had reported serious difficulties resulting from the two measures, in particular, compa nies 
were facing long delays in the registration process, in some cases extending for months before a 
confirmation of registration was issued by the Ministry of Trade. Moreover, she said, the 
registration process lacked transparency, as the list of registe red companies had not been made 
available to the public, and not even to the companies involved.  
2.288.    The representative of the United States  said that whilst Egypt had provided further 
guidance on its website on how to comply with Decrees 43/2016 and 991/201 5, her delegation 
remained concerned over Egypt's level of transparency during the adoption and enforcement of 
these measures and the burdensome nature of the requirements. She drew particular attention to 
Egypt's written response to her delegation's conce rn about the inadequate period of time to 
consider stakeholder comments submitted in response to its WTO notification, in which Egypt had 
responded that the registration requirements were administrative in nature and did not impose 
further burdens on produ cers or companies in the exporting markets. She maintained that one of G/TBT/M/70  
 
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  the key points of stakeholder comments was to understand what burdens might exist and how 
they could be mitigated in a manner that would still allow the Member to fulfil its objective. Egypt 
had further stated that a two -month transitional period was enough to carry out the registration 
process and that there had been over a thousand registrations.  The US, however, had received 
complaints from companies which had submitted all required d ocumentation but had nonetheless 
experienced serious difficulties registering. Moreover, it appeared that some 18,000 requests were 
pending approval with the Ministry of Trade and that overall US exports to Egypt for the most 
products covered by the decree  were down 32% for the January –August 2016 period.   
2.289.   In this context, the US reiterated that had Egypt notified the first draft of the measure for 
a 60-day comment period, Egypt could have reflected on the comments received and made any 
necessary changes to  the draft accordingly. Additionally, upon publication of the measure, Egypt 
should have allowed an adequate time – at least six months - for producers to adapt to the new 
requirements which would have allowed enabled Egypt to process documentation whilst avoiding 
backlogs and unnecessary disruption in trade for foreign importers already registered with the 
Trade Ministry and other relevant ministries.  
2.290.   Recalling that the measure in question specifically targeted imports, the US again asked 
Egypt how it had ensured that it was consistent with its national treatment commitments. Further, 
as a result of Egypt's immediate implementation and lack of transparency, whilst some US 
companies reported total withdrawal from the Egyptian market, others continued to indi cate 
confusion about the documents and certifications which would be accepted to demonstrate 
compliance, as well as the backlog of applications preventing approvals or serious difficulties 
registering.  
2.291.   In light of the above, the US requested the following , as a matter of priority: (i) that Egypt 
suspend implementation of the measure until all stakeholder comments had been taken into 
account; (ii) that Egypt change its approach from a horizontal one that impos ed the same 
requirements across many industries to one that takes into account the various global norms, risk 
factors, and practices across different industries and commodities; (iii) that regarding the 
requirement for a Quality Management System certification, Egypt recognize that international 
standar ds and best practices to control for quality differ by industry; (iv) that Egypt consider how 
this new requirement which is duplicative of existing requirements for registration and certification, 
including those implemented by other ministries, may meet t he objectives of the proposed quality 
certificate requirement; (v) that Egypt continue to engage with the US and other trading partners 
to address these concerns; and (vi) that Egypt continue working with all stakeholders to ensure an 
approach not more tra de restrictive than necessary to accomplish its regulatory objective.  
2.292.    The representative of Switzerland  reiterated concerns raised during the previous 
Committee meeting regarding Decree No. 43/2016, in particular its entry into force before the end 
of the  notified comment period. He recalled that Decree No. 43/2016 provided for the registration 
of foreign factories and trademark owners of products imported into Egypt and that this procedure 
required, inter alia , a certificate testifying that a quality cont rol system had been reviewed by a 
third party. Switzerland encouraged Egypt to consider a less trade -restrictive approach, bearing in 
mind that in most markets, several products covered by the decree were not subject to third -party 
quality control. Moreove r, in Switzerland, third -party quality control was required for certain 
products presenting risks even if the absence of third -party production certification did not 
necessarily mean that a product was unsafe. He reported that Swiss enterprises that had no t 
implemented a quality management programme or had chosen to ensure quality management 
independently, were finding it difficult to adapt quickly and to understand the requirements 
established by Egypt. His delegation was concerned about how Decree No. 43/ 2016 would 
contribute to the objectives of protecting public health and the environment, and the extent to 
which third -party certification had been generalized to cover 25 very diverse product sectors. He 
requested an update on the implementation of proced ures and on the future of the "white list" 
mentioned during the June meeting.  
2.293.    The representative of Ukraine  voiced support for the positions of the EU, US and Turkey. 
She said that reports from domestic producers indicated that the Egyptian measures creat ed 
unequal conditions due to the costs incurred by the additional requirements for legalization of 
product certificates. Ukraine was of the view that the measures might not be in line with WTO 
commitments and to illustrate their position cited the inspecti on and verification of certificates' 
conformity with Egyptian standards, as well as customs processing of products being subject to G/TBT/M/70  
 
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  random checks by the GOEIC. In addition, Ukrainian businesses had been given very little time to 
adapt to the requirements o f the decrees due to the short timeframe between their adoption and 
entry into force, leading to the creation of unnecessary trade barriers between Ukraine and Egypt. 
Ukraine therefore asked Egypt for further explanation as to the grounds for such swift 
implementation and the choice of measures which appeared to be unnecessarily trade restrictive. 
Egypt was urged to suspend implementation of the decrees and to re -notify when the effects had 
been analys ed and a revised proposal made.  
2.294.    The representative of South Africa  said that his delegation remained concerned about the 
measure, and expressed interest in a speedy resolution to the matter that would facilitate trade 
rather than hampering it, as was currently the case.  
2.295.    The representative of Australia  voiced support for the concerns raised by other Members 
on Egypt's proposed manufacturing registration system which her delegation deemed more 
restrictive than necessary to achieve its objectives. Australian businesses were already feeling the 
effects of the regu lations and had raised several concerns to the Australian Government that the 
new registration and certification requirements created an unnecessary barrier to trade. Her 
delegation encouraged Egypt to take a risk -based approach to certification and confor mity 
assessment requirements in consideration of international standards for product quality assurance.  
2.296.    The representative of Canada , echoing the issues raised by other Members, expressed 
concern with these measures, the development of which they would c ontinue to monitor.  
2.297.   The representative of Egypt  referred to their response from the previous Committee 
meeting, and highlighted some specific points regarding implementation.13 First, he reiterated that 
notification G/TBT/N/EGY/114 referred to a different i ndependent ministerial decree and did not 
require double registration. Decree No. 43/2016 required registration for the manufacturing plants 
and trademark owners of products imported into Egypt whilst Decree No. 991/2015 dealt with 
preshipment inspection t o ensure product conformity with relevant Egyptian standards. Second, he 
assured Members that since the adoption of the new decrees, the Ministry of Trade and Industry 
had concentrated all its efforts on accelerating the registration process and handling a ny obstacles 
faced by individual companies, as reflected in the increasing number of companies registered to 
date. Third, on quality certification, Egypt confirmed that any certificate issued from an accredited 
entity would be accepted. He added that a cop y of the certificate would equally be accepted if 
Egyptian authorities could access an electronic version on the database on accredited certification 
service providers. This flexibility was intended to facilitate registration. Fourth, on the power of the 
ministers to exempt  manufacturing plants and trademark owners from the registration 
requirement, Egypt confirmed that this exemption would only be applied in emergency situations 
and to date had not been invoked. Finally, his delegation confirmed that Egypt ian manufacturing 
plants and companies were also subject to registration surveillance and inspection requirements by 
numerous Egyptian regulatory authorities to ensure compliance with relevant regulations.  
2.298.   Egypt reiterated its belief that the registration  requirement under Decree No. 43/2016 was 
not more trade restrictive than necessary and confirmed its commitment to being in full 
compliance with all articles of the TBT Agreement. Nonetheless, he invited delegations to initiate 
bilateral contact in case o f any registration obstacles or delays.  
2.2.3.41   Kenya — East African Community (EAC) alcoholic beverage standards  (IMS ID 
510)  
2.299.   The representative of t he European Union  reiterated support for Kenya and other Members 
of the East African Community in their efforts to achieve their legitimate objectives while 
respecting their WTO obligations. At the last TBT Committee  meeting , the EU asked Kenya to 
notify a set of new technical regulations that had been adopted without prior notification to the 
WTO. These  were causing significant problems to EU exporters of alcoholic beverages. Following 
that request, Kenya had notified these me asures to the WTO and the EU  had submi tted comments  
on some of them. While not going into detail  on the content  of the nine sets of comments on the 
different technical regulations, she highlight ed a common request that technical regulations for 
alcoholic drinks be aligned to the Recommendations of the OIV, including the International Code of 
Oenological Practices, and to the CODEX standard on Labe lling of Prepackaged Foods (CODEX 
                                                
13 G/TBT/M/69, paras. 3.25 -3.28. G/TBT/M/70  
 
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  STAN 1 -1985). The EU believed  that widely accepted international standards and practices 
correctly address ed Kenyan legitimate objectives. Based on the above -mentioned elements, the 
EU reiterated the provisions contained u nder Article 2. 4 of the TBT Agreement . The EU requested 
that Kenya provide an update on the revision process of these technical standards. The EU noted  
the next meeting of the responsible technical committee of  the East African Community would  take 
place on 28 November  - 2 December 2016 . She requested that Kenya ensure  that the comments 
provided were transmitted to this technical committee so as to be  taken into account in the 
revision process.  
2.300.   The representatives of the United States strongly s upport ed the EAC's desire to protect its 
citizens and reduce the consumption of ad ulterated alcoholic beverages. The US recognize d the 
importance to public health which these measures were intended to address and wish ed to 
collaborate with the EAC in the achievement  of these goals through its own experience in the  US. 
The US acknowledged the notification of the EAC alcohol standards in response to their request at 
the last TBT committee meeting in June. She thanked  Uganda for the response to their written 
comments  and urged Tanzania and Burundi to also notify these alcohol standards to the WTO . The 
US welcome d the news that several standards would  be considered for  possible revisi on during the 
next EAC review. However, the US request ed continued technical engagement on  the remaining 
standards which Uganda noted they did not intend to adjust. These standards were not in line with 
international practices . The US requested that the EAC Members provide the scientific rationale on 
which these regulations were based.  Furtherm ore, the US requested that member countries 
consider  regulatory approaches of other we ll-established trading partners. The US welcome d 
discussions with EAC members on finding a solution that could  fulfil their legitimate objectives 
without unnecessarily re stricting trade, such as greater alignment with sta ndard international 
practices. If Tanzania, Kenya, and Burundi intend ed to adopt EAC standards on alcoholic 
beverages, the US asked for the opportunity to provide comments prior to finalization of the 
standards . The US has previously submitted comments to Uganda, Rwanda, and Kenya expressing 
the unnecessarily trade -restrictive impact of these standards. The US welcome d a response to 
their comments submitted to Kenya in August. She requested  that a date or t imeline be provided 
as to when the EAC would  next meet to discuss revisions to the alcohol standards. The US 
reiterated its interest in the discussions as well as  collaboration on standards and conformance 
through technical exchange and further discussions . The US urged EAC member states to notify 
new trade restrictive regulations while still under development in the EAC and prior to 
implementation to allow for meaningful consultation with trading partners in keeping with WTO 
commitments. She reiterated US interest  in discuss ing Kenya' s, Tanzania 's and other EAC 
members ' plans to implement alcohol standards.  
2.301.   The representative of Kenya  stated that i n July 2016, the Regional Harmonized Alcoholic 
Beverage Standard was notified the WTO . Subsequent ly Kenya had received comments from the  
delegations of the EU and US. Kenya  explained that th e EAC Alcoholic Beverage Standards were 
regional harmoniz ed standards . Kenya had brought this STC and the comments provided  by the 
EU and US to the a ttention of the EAC Secreta riat. Kenya continued to explain that t he EAC 
Alcoholic Beverage Standards were due for review. Conseq uently, the EAC Secretariat would  soon 
be convening a Joint Regional Technical Committee meeting to discuss and share the comments 
that ha d been raised on  the EAC harmonized Alcoholic Beverages Standards. At the national level, 
the Technical Committee on Alcoholic Beverage Standards would  meet on 16 November 2016 to 
consider the comments raised by the EU, US and other Members of this Committee. The outcome 
of this national process would  feed into the EAC consultative review process.  Kenya was available 
for further discussions with the delegations of the EU, US and any other interested delegations so 
as to address their concerns.  
2.2.3.42   European Union - Quality Sche mes for Agricultural Products and Foodstuffs 
(IMS ID 512) 
2.302.   The representative of the United States  noted that Denmark had applied for the 
registration of the name "danbo" and "havarti" as protected Geographical Indications (GIs) for 
cheese through the EU Qu ality Schemes for Agricultural Products an d Foodstuffs. However, Codex 
had well-established and long -standing standards for these two cheeses – 50 years ago, in the 
case of "danbo", and 30 in the case of "havarti". Sh e said these standards recognized  these  were 
common types of cheese that were traded internationally.  The Codex standards had been adopted 
to facilitate quality and uniformity of these cheeses in the various countries producing them.  G/TBT/M/70  
 
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  2.303.   Although both applications were still pending, the US was con cerned that, if granted, these 
GI registrations would result in the prohibition of the use in the EU of the two names for any 
cheese produced outside of Denmark. Accordingly, the US was concerned that approval of the 
applications under the Quality Schemes for Agricultural Products and Foodstuffs would  effectively 
ban from  the European market any common -name cheeses using the international compositional 
standards established by Codex. The US first enquired as to whether the applications related to 
these two names were approved within the EU.  Second, she asked if the EU would seek to use 
international treaties to prohibit cheeses being sold in other markets from using the Codex -
standardized terms on the products' labels, even if those cheeses conformed to th eir respective 
Codex standards.  
2.304.   Finally, her delegation understood the EU had con sidered and rejected less trade -
restrictive means of implementing regulations pertaining to "danbo" and "havarti". For instance, 
the US said the EU could require the application s to be amended to cover only "Danish Danbo" or 
"Danish Havarti", while providing accompanying clear statements that products produced and 
labelled in accordance with the Codex standards for "danbo" and "havarti" could  continue to be 
sold in the EU market.  She requested that the EU explain its Quality Schemes for Agricultural 
Products and Foodstuffs as it related to the se products, and clarify why tho se alternatives did not 
meet the EU's objective in this case.  
2.305.   The representative of the European Union  expla ined that the procedure for granting of 
protection to the terms "Danbo" and "Havarti" as GIs in the European Union had not yet been 
finaliz ed, as already indicated to the US bilaterally. Therefore, the EU had no further comments on 
this issue. Furthermore,  the EU noted that the elements raised by the US delegation pertain ed to 
intellectual property rights, in particular to GIs. The EU believed that any issues concerning 
intellectual property rights would be more appropriate for discussion in the relevant Co mmittee 
responsible for intellectual property, notably  the TRIPS Council. In any case, the EU remained open 
to discuss this issue bilaterally with the US.  
2.306.   The representative of the United States  recalled that the EU had notified this measure to 
the TBT Com mittee, which was the reason her delegation had raised this issue in the TBT 
Committee and not the TRIPS Council.  
2.307.   The representative of the European Union  stated that  this regulation had been  notified to 
the TBT Committee because it included elements in ad dition to GIs, elements which were covered 
by the TBT Agreement.  
2.308.   The representative of the United States  said the measure covered  GIs, but also Codex 
standards which were pertinent to the work of the TBT Committee. The US stressed that Codex 
standards were  relevant for the EU determination of whether to grant these GIs, which  was why 
her delegation had ch osen to raise this STC in the TBT Committee.  
2.2.3.43   European Union — Directive 2014/40/EU on the approximation of the laws, 
regulations and administrative provisi ons of the member States concerning the 
manufacture, presentation and sale of tobacco and related products and repealing 
Directive 2001/37/EC (IMS ID 5 13) 
2.309.   The representative of Indonesia  requested  that the EU respond to its written enquiry sent 
the EU TBT Enquiry Point on 25 June 2016. EU member States were required to implement the EU 
Tobacco Directive into  their local laws by 20 May 2016, and  the majority had notified its national 
implementation measures to the E U Commission . Article 7(1) prohibit ed membe r States from 
placing tobacco products with a "charac terizing flavour" on the market. T he European Commission  
had adopted Implementing Decision 2016/786 o n 18 May 2016 (the "Implementing Decision") to 
lay down the procedure for the establishment and operat ion of an independent advisory panel 
tasked with assisting EU member States and the E U Commission in determining whether tobacco 
products ha d a "characterizing flavour ". Implementing regulation 2016/799 of 18 May 2016, 
issued by the European Commission, es tablished  uniform rules for the procedure to determine 
whether tobacco products ha d a characterizing flavour  (the "Implementation Regulation").  
2.310.   Kretek, a traditional tobacco product, was an important Indonesian export product, with an 
export value of abou t USD 600 million a year. While Hungary had already taken  steps to ban  the G/TBT/M/70  
 
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  sale and import of Kretek into their territory claiming it was a tobacco product with characterizing 
flavour, the above -mentioned advisory panel ha d not yet been set up and the proc edure to define 
what should be considered a characterizing flavour, set out in regulation 2016/799, ha d not been 
followed. For example, Article  4 request ed that m ember States implementing the directive should  
inform manufacture rs and importers that the con cerned tobacco product was considered to have a 
characterizing flavour, initiating a dialogue on the product. In case of dispute,  a referral  of the 
information  should be made to an advisory panel (Article  6 and 7 ). To the Indonesian 
Government's knowledge,  no Indonesian manufacturer importing Kretek in the EU ha d been 
contacted by a member State or the EU Commission. The representative requested the EU to 
explain the legal basis for the ban on  Kretek established by some EU m ember States.  
2.311.   Indonesia pointed out that Article 7.14 of directive 2014/40/EU stipulate d that tobacco 
products with characterizing flavour whose EU -wide sale volumes represent ed 3% or more in a 
particular product category would only be subject to application of the Article 7(1) prohibiti on as of  
20 May 2020. Indonesia believed  this measure was tailored to menthol cigarette 
producers/importers. The vast majority of menthol cigarettes sold in the EU was produced 
domestically. Based on these facts, Indonesia stated its opinion that Article 2 .1 of the TBT 
Agreement applied to A rticle 7.14 of directive 2014/40/EU, as t he measure, in practice, exempted  
menthol cigarettes from the prohibition discussed in Article  7.14. Therefore i mported Kretek was 
treated less favourably  than domestic menthol ci garettes. Indonesia referred to the dispute 
DS406, in which the DSB concluded that a similar measure introduced in the US, prohibiting 
imported clove cigarettes while not prohibiting domestically produced  menthol cigarettes, was 
inconsistent with the no le ss favourable treatment obligation in Article 2.1 of the TBT A greement.  
2.312.   Similarly, Indonesia believed that Article 9 of the Implementing Decision was also 
inconsistent with Article 2.1 of the TBT Agreement. Article 9 impose d a specific methodology to 
determine " characterizing flavour", which was to be based on a comparison of the smelling 
properties of the test product with those of reference products. Indonesia considered that by 
restricting the methodology to s melling properties, and excluding tasting me thodology properties, 
this provision inherently discriminated against Kretek . Kretek was , according to Indonesia, a 
different tobacco product category,  typically composed of up to 40% clove . Clove was thus a 
fundamental part of the kretek cigarette. Regula r cigarettes consumed in the EU  could not  be used 
as reference product  to determine whether Kretek had  a characterizing flavo ur.  
2.313.   The representative of the European Union  stated that written comments received from 
Indonesia on this issue are currently unde r analysis and a reply on specific concerns on Kretek 
would be provided. The EU stated it preferred to discuss the Indonesian concerns at bilateral level 
and remained available for bilateral contacts.  
2.2.3.44   Chinese Taipei — Draft  of the Organic Agriculture Act,  G/TBT/N/TPKM/225, 
(IMS ID 511)  
2.314.   The representative of the European Union  thanked Chinese Taipei for notifying the Draft of 
the Agriculture Act on which it had sent comments on 2 February 2016. In these comments, the 
EU considered that clarity was needed on  the scope of the proposed measure with respect to both 
its product coverage and process stage coverage. The EU also considered that the draft measure 
needed to include production and control rules on organic farming.  In the EU's view, the most 
critical el ement of the proposed measure was Article 37, which stated that countries that had been 
recognized as having equivalence regarding organic imports before the notified draft was 
implemented would have to re -apply for recognition and that a new bilateral pro tocol or agreement 
would then have to be signed within one year of the implementation of the notified draft. If the 
one-year timeframe for signature was not respected, then the bilateral protocol or agreement with 
the third country concerned would be revok ed by Chinese Taipei. The EU thus considered that the 
implementation period of one year did not allow trading partners sufficient time to re -apply for 
recognition and to conclude the required ratification process of the new bilateral protocol or 
agreement.  In addition, the EU considered that the penalty imposed for exceeding the one -year 
timeframe was too strict. The draft measure  in its current form would be more trade restrictive 
than necessary.  
2.315.   She noted that at the previous TBT Committee meeting, Chine se Taipei had not refer red to 
a specific time -frame for the adoption of the measure and that at bilateral meetings it indicated 
that the measure could be adopted in the first half of 2017. The EU understood that the measure G/TBT/M/70  
 
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  was still under development and therefore renewed its request to Chinese Taipei to consider EU 's 
comments and the possibility of a reasonable extension of the timeframe to re -apply for 
equivalence.  In similar circ umstances the EU granted a five -year extension . The EU asked  how 
Chinese Ta ipei intended to take into account the comments and  for an update on the current 
status and timeline for adoption of the notified measure. She also requested a written response to 
the submitted  comments.  
2.316.   The representative of Chinese Taipei  said that the draft was proposed to establish  a 
specialized law for the management of organic agricultural products and to make the legislative 
framework clear and easy to understand. The draft was designed to address: (i) challenges arising 
from rapid changes to the do mestic production environment of organic agricultural  products; 
(ii) consumers'  heightene d expectations; and (iii) cross -border trade problems of Chinese Taipei 
organic agricultural products. He stated that the draft did not af fect the implementation detai ls; 
these were currently specified in the regulation entitled "management regulations for certifying 
organic agricultural products and organic agricultural processed products ". He indicated that the 
coverage of products and process stages were prescribed i n the regulations and he expressed 
willingness to provide a copy for EU' s reference. He stated that the draft was under administrative 
review and his delegation currently had no update. The comments on the extension of the 
timeframe for concluding new bila teral equivalency agreements and others would be carefully 
considered. Chinese Taipei would continue bilateral discussions and consultations with interested 
Members on equivalency so that trade in organic agriculture products could benefit from the 
arrange ments immediately after the adoption of the act.  
2.2.3.45   Colombia — Draft Resolution of the Ministry of Health and Social Welfare and 
the Ministry of the Environment and Sustainable Development adopting the Technical 
Regulation establishing the maximum levels of phosphorus and the biodegradability of 
surfactants in detergents and soaps, and introducing other provisions , 
G/TBT/N/COL/214 and G/TBT/N/COL/214/ Add.1,  (IMD ID 506) 
2.317.   The representative of Mexico  was concerned with certain aspects of the Colombian 
measure  notified on 12 May 2016 . She noted that Article 7 of the measure required the la boratory 
testing of surfactants' biodegradability contained in detergents and soaps, which could only be 
carried out in laboratories accredited by Colombia . Currently no laborat ory had been accredited 
and this was not a practicable option for Mexico where approved laboratory tests were not 
designed to be conducted on the finished product. She also indicated that these requirements on 
testing surfactants ' biodegradability of deter gents as an end product were more restrictive than 
necessary to fulfil the measure 's legitimate objective. As surfactant agents were the main 
component of detergents, in addition to an organic compound, this implied that the surfactants 
were also biodegrad able substances and therefore the tests would be a redundant conformity 
assessment procedure.  
2.318.   Given the foregoing reasons, Mexico requested that Colombia reconsider the relevance of 
performing laboratory tests on soaps and detergents to determine the permi tted biodegradability 
limits of surfactants, or allow for the recognition of tests that had been performed in other 
countries. Mexico also asked for an update on the status of the measure, since a version published 
in the Colombian  Official Journal extende d the scope to include cosmetic and hospital soaps and 
detergents in addition to the domestic and industrial products already covered. Mexico considered 
this version to be inconsistent with the Addendum 1 notified to the WTO. Finally, Mexico asked 
Colombia  for a bilateral meeting to clarify the incompatibility of their regulations.  
2.319.   The representative of Colombia  noted that Mexico had not informed its TBT contact point 
that it intended to raise this STC during this meeting. During the public consultation, Colombia had  
received comments from the Chamber and Association of the Industry of Personal Care and Home 
Care (CANIPEC), but not from Mexico. As the TBT Committee was an intergovernmental forum, 
Colombia asked comments to be made directly by Mexico. She no ted that these comments had 
been transmitted to the Ministry of Environment and Sustainable Development and that this 
authority had published on its website a compendium of the replies to comments from the national 
and international public consultations .14 The Administrative Decision had entered into force in 
                                                
14 http://www.minambiente.gov.co/index.php/at encion -y-participacion -al-ciudadano/consultas -
publicas#comentarios  
 G/TBT/M/70  
 
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  November and had been  notified to the WTO. Colombia therefore asked other delegations to 
review this document and to submit comments on the measure through official channels .  
2.320.   This technical regulation had been  developed on the basis of the National Quality 
Subsystem guidelines under which conformity assessment processes differ ed in complexity and 
cost depending on the risk they sought  to mitigate. The draft standard selected first -party 
conformity asses sment, which did  not require a certifier or a third guarantor. Therefore, economic 
operators could produce evidence in their own laboratories or where they deemed appropriate. She 
explained that the technical regulation applied in Colombia to prevent the e nvironmental and 
health impacts  of non-biodegradable surfact ants in detergents and soaps by ensuring  that these 
products d id not exceed  the maximum limits of phosphorus and polluting substances that were not 
easily biodegradable . This measure had been  agreed in consultation with producers and importers 
and she said that it had not been considered to be an unnecessary barrier to trade during 
consultations at the WTO.  
2.321.   Soaps only containing surfactants obtained from natural sources through saponification or 
neutralization of fats, oils, waxes, rosin or their acids of organic or inorganic bases were exempted 
from the biodegradability requirement, in accordance with the paragraph of Article 6 of Resolution 
689 of 2016. With regard to the request to include the te st methods listed in NMX Q 901 CNCP of 
2015, Colombia could consider  this proposal when Members agree d to work on  bilateral or 
harmonization  of sub -regional technical regulations . She highlighted that when the notified draft 
was revised and compared with R esolution 689 of 2016, no substantial differences were found and 
there was no extension of the scope of application. The tariff headings were the same and referred 
to all soaps and detergents with surfactants that pollute and exceed the maximum levels of 
phosphorous, regardless of their use.  
2.322.   She said that the measure was in harmony with European guidelines and that the Ministry 
of the Environment and Sustainable Development had received comments from domestic industry. 
Her delegation considered that these products had a global trend towards standards of hygiene 
and cleanliness associated with developed regions such as Europe. Also, consumers preferred 
products of plant origin because of concerns for the preservation of health and the environment. 
Colombia invited  Mexico to review the measure and submit comments through official channels.  
2.2.3.46   China — National Standards on Limits of Volatile Organic Compounds for 
Furniture , G/TBT/N/CHN/1094 , G/TBT/N/CHN/1095 , G/TBT/N/CHN/1096 , (IMS ID 
509)  
2.323.   The representative of th e European Union  thanked China for having notified these three 
standards which, because they were intended to become mandatory, were akin to technical 
regulations. The EU continued to have a number concerns, of which the most important were 
(i) the propose d "mandatory  standards " include d unnecessary deviations from well -known, 
international ISO standards. In case such standards became mandatory, products which were 
currently assessed on the basis international standards would have to be assessed for the Chi nese 
market on the basis of specific tests ; (ii) some of these specific tests require d a complex and 
costly assessment, such as multiple test chambers and a new test chamber for mattresses ; and 
(iii) there were significant doubts among industry about the r elevance of the tests with regard to 
the presence of harmful elements to be measured – Total Volatile Organic Compound (TVOC) 
measure d a sum of harmful and harmless substances - and also about the replicability of the tests.  
2.324.   It was noted that at the previo us Committee meeting, China had indicated that deviations 
from international standards would be justified by realistic conditions of use. It was the EU 
understanding that the notified standards were still under development. The EU appreciated the 
openness of China in engaging with the relevant stakeholders with a view to revise the draft 
standard.  
2.325.   The EU understood that TVOC  requirements would be applied on a voluntary basis and 
sought confirmation of this, as well as clarification about which parts of the  standard would remain 
voluntary and which would be mandatory. In particular, the EU wished to know whether either the 
TVOC limits set out in the standards, or the testing methods and their annexes would be 
considered as voluntary, or both. Moreover, would  this differentiation apply to all three notified 
draft standards? The EU also asked for information from the Chinese authorities about t he G/TBT/M/70  
 
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  intended status, voluntary or  mandatory, of the other limits and requirements included in the 
notified drafts (e.g. formaldehyde emissions).  
2.326.   The EU encouraged the Chinese authorities to accept equivalent international standards, in 
particular ISO standards, for the product categories covered by the notified drafts. Should China 
consider that the relevant ISO standards c ould be improved, the EU invited China to bring its 
proposals for discussion to the ISO as this would enable improvements to be considered without 
creating differences between Chinese and international standards and would thus avoid 
unnecessary barriers to  trade. The EU also asked for a timeline for the adoption of the notified 
drafts.  
2.327.   The representative of China  said that the EU's concerns appeared mainly to be on technical 
aspects, such as testing methods. Chinese experts had prepared the technical detail s on the 
procedure for how testing methods were determined, and, in bilateral meetings during the 
previous day, these had been conveyed to the EU delegation. It was stressed that the Chinese 
standards adopted the testing methods mainly based on internation al standards; they did not vary 
from international standards. There were several points in Chinese testing methods that could 
differ from international standards, but these were all designed to simulate realistic conditions for 
use so that the testing resu lts would be more scientific. China had notified the three standards to 
the WTO in July 2015 and provided 60 days for comment. At the request of the EU, China had 
extended the comment period for one more month and had studied the EU comments carefu lly 
upon receipt. A s stated above, answers had been conveyed and further discussions could be 
undertaken on a bilateral basis.  
2.2.3.47   Peru — Implementing Regulations of 14 November 2012 for Moratorium on 
Planting Genetically Engineered Crops  (IMS ID 392)  
2.328.   The representati ve of Mexico  referred to the Peruvian L aw establishing a ten -year 
moratorium on the entry into and production of living modified organisms on the national territory 
(Law No.  29811) that had been published in the Official Journal El Peruano  on 9 December  2011. 
This law established a moratorium on the introduction into – and production of – Living Modified 
Organisms (LMOs) for the purposes of cultivation or breeding, including aquatic organisms, for 
release into the environment. The Regulation implementing th is law had been published in the 
Official Journal El Peruano  on 14  November  2012. In addition to preventing the entry, production 
and release of LMOs, the objective of Law No.  29811 included building national capacities, 
developing infrastructure and gener ating basic guidelines that allowed for the proper assessment, 
prevention and management of the potential impact of the release of living modified organism s 
(LMOs)  into the environment. In this respect, the Mexican industry that produced hybrid maize 
(corn ) had a number of concerns.  
2.329.   First, Article 4 "Accreditation" of the Law stated that "all genetic material that enters the 
national territory […] must be accredited as not being a LMO. If the material analyzed is shown to 
be an LMO, the Competent National A uthority shall proceed to seize and destroy it and apply the 
appropriate sanctions". The Mexican seed industry had t ested the fitness of seeds by means of 
production processes based on good management practices, quality assurance, and quality control 
systems, so as to ensure varietal purity and so as to facilitate the international seed trade. 
However, because of the very nature of the biological system, low -level unintended genetic 
impurities, including genetically modified events, could occur. At the same  time, existing detection 
techniques had a certain margin of error that could produce false positives or false negatives.  
2.330.   The internationally recognized seed quality standards for identity and varietal purity were 
those established under the OECD and Assoc iation of Official Seed Certifying Agencies  (AOSCA ) 
seed schemes. Considering that a conventional seed might contain unintended low levels of 
genetically modified events (less than 2%), Mexico was concerned about the zero tolerance 
established in the regul ations in question and the consequences of the unintended low -level 
presence of genetically modified events being detected in conventional seed, with the possibility of 
its being deemed to be an LMO and the shipment seized and destroyed or sanctions – which could 
amount to several  million US dollars – being imposed on the exporter.  
2.331.   Mexico considered that this could constitute non -compliance with the provisions of Articles 
5.1.2 and 5.2 of the TBT Agreement, since the conformity assessment procedure set out in the G/TBT/M/70  
 
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  Law represented an unnecessarily restrictive obstacle for the Mexican export industry – particularly 
because of the penalties that did not allow for the taking of corrective measures if the seed 
shipment was found to contain LMOs. In addition, estab lishing a zero tolerance for the 
identification of genetically modified events during the assessments carried out as a prerequisite 
for entering Peru meant disregarding the existence of less trade -restrictive alternatives which did 
not affect the fulfilmen t of the legitimate objective, such as the imposition of a threshold of 2% of 
genetically modified events. In view of the a bove, Mexico requested the following: (i) that Peru 
recognize the OECD and AOSCA  purity standards and their certification as equivale nt to the 
requirements imposed by the Law in question, in order to avoid GMO  inspections at the border;  
(ii) where appropriate, consider recognizing non -LMO certificates issued by third –party laboratories 
that were certified by a recognized authority and a ccepted, by the standards of the Peruvian 
authorities, at the port of loading, instead of subjecting shipments to inspections at the border;  
(iii) promote bilateral dialogue with regulatory bodies that were studying the question of low LMO 
levels in batche s of conventional seed, together with the determination of thresholds and detection 
technologies;  and (iv) take into account the position of the Mexican seed industry and the 
positions of the other countries affected by the considerations of this conformit y assessment 
procedure.  
2.332.   The representative of Peru said his country was considered to have a rich biodiversity with 
wide-ranging ecosystems and genetic resources. With regard to the trade concern expressed, Peru 
reiterated that the establishment of a morat orium on genetically engineered crops had been for a 
period of ten years. The regulation at issue was considered to be an environmental measure and 
therefore it did not need to be notified to the WTO under TBT Agreement's requirements – this 
was, he said, a law intended to protect biodiversity.  
2.2.4   Exchange of Experiences  
2.333.   The moderators for the thematic sessions made the following reports:  
a. Mr. Tim Ward (Australia) on technical assistance  (G/TBT/GEN/205 ); 
b. Mr. George Opiyo (Uganda), Ms Siti Mariam Mohd Din  (Mala ysia) and Mrs Jo -Anne 
Beharry (Trinidad and Tobago)  on regulatory cooperation between Members ( Food 
Labelling ) in G/TBT/GEN/205; and,  
c. Ms Esther Peh (Singapore, Chairperson) on the Information Exchange Meeting, including 
the thematic session on transparency  (G/TBT/GEN/2 06).15  
2.2.4.1   Topic of the next Thematic Session  
2.334.   The representative of Chinese Taipei  suggested that the Committee organize a thematic 
session on the topic of Risk Assessment. The full proposal is contained in document JOB/TBT/211.  
2.335.   The representative  of Indonesia  proposed for following for the March  Thematic Sessions:  
a. to highlight the implementation of standards by SMEs;  
b. a discussion on forestry issues, especially issues related to "timber legality" often used 
as an un necessary barrier to trade. Thes e barriers were caused by high standards and 
technical requirements aimed at reducing illegal logging and protecting the environment; 
and,  
c. regulatory reform under the framework of good regulatory practices.  
2.336.   The representative of South Africa  proposed that  the Committee follow the same schedule 
of topics that had been proposed for the March 2016 meeting, that is: one thematic session  on 
GRP and one on Conformity Assessment. With regard to GRP, South Africa welcomed Chinese 
Taipei's proposal and support ed further discussions on risk assessment.  
                                                
15 A full summary report of this meeting is annexed to this report.  G/TBT/M/70  
 
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  2.337.   The representative of Canada  supported Indonesia both with respect to a discussion on 
SMEs and standards as well as an examination on national forest management frameworks – the 
latter could be useful in exploring diff erent ways Members achieve environmental objectives in the 
forestry sector.  
2.338.   The representative of China  was open to discuss the issues mentioned; however, he noted 
that the TBT Code of Good Practice had been discussed less in the Committee and proposed mor e 
discussions with an emphasis on the Code and its acceptance by non -governmental standardizing 
bodies, pursuant to para 2.10.c of the S eventh Triennial review and para 7(a) of the Sixth 
Triennial Review.  
2.339.   The Chairperson  noted that her intention had been to get a sense of the topics Members 
had an interest in , and not to come to any decision at the current meeting. She took note of the 
ideas expressed and announced her intention to make herself available for consultation with 
interested Members.  
2.2.4.2   Other  
2.340.   The representative of South Africa  requested that the Secretariat update document 
G/TBT/1/Rev.12 to include the recent decisions and recommendations.  
3  TECHNICAL COOPERATIO N ACTIVITIES  
3.1.  The representative of ISO informed the Committee that the Actionplan for Developing 
Countries 2016 -2020 was now being implemented. There were currently over 20 regional 
activities , to expand to 30 in 2017. There had been significant cooperation with the WTO 
secretariat and a number of other international organizations. A workshop  on the theme of 
standardization and public policy in Singapore had been very well received. He thanked the WTO 
Secretariat which had given  a very important contribution. The next event would take place in 
Uruguay where the WTO Secretariat would also contr ibute. Further details were available  on the 
ISO website.16 He further informed the Committee that a t the September ISO General Assembly, 
one of the key themes was the SDGs and the role of standards. There was much focus on the 
cooperation with internationa l organizations in achieving these objectives. For the first time, t he 
World Bank gave the keynote speech in the DevCo meeting where they addressed the role of 
standards in support of SDGs in developing countries.  
3.2.  The representative of the IEC informed the  Committee that the IEC Regional Centre for Africa 
had visited a number of IEC members and affiliate countries providing support to the national 
committees of Cameroon,  Benin, Burundi Mali, Mauritania, Niger, Democratic Republic of the 
Congo , Rwanda, Tanza nia, Togo, and Uganda. The Latin American  Regional Centre ha d visited 
Chile and Peru to offer training to technical experts and government authorities. On C onformity 
Assessment , the IEC in collaboration with COPANT (the Pan -American standards commission) P TB 
(the German national metrology institute) and INTECO (the Costa Rican n ational standards 
institute ) would  hold a workshop at the end of November on the topic of IECEE conformity 
assessment  schemes increasing participation in international standardizatio n, and electrical 
installation codes . This  event was targeted towards regulators, standardization and certification 
bodies in the region.   
3.3.  The S ecretariat made available a document on the TA activities contained in G/TBT/GEN/ 212.  
4  UPDATING BY OBSERVER S 
4.1.  The representatives of UNECE , OECD , CROSQ , IEC, and OIML updated the Commi ttee on 
their activities. 17 
4.2.  The representative of ISO reminded the Committee of the importance of the role of standards 
in supporting the SDGs. Some recent developments in this area inc luded ISO TC 268 on 
Sustainable Cities and ISO TC 282 on water re -use. Recently published standards included those 
                                                
16 http://www.iso.org/iso/iso_action_plan_2016 -2020_en_ld.pdf  
17 G/TBT/GEN/207, G/TBT/GEN/208, G/TBT/GEN/209, G/TBT/GEN/210, G/TBT/GEN/211  G/TBT/M/70  
 
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  on Evaluation of Energy Savings and Anti -bribery Management Systems. A standard on 
Sustainable Procurement Guidelines (ISO 20400) would be pu blished in early 2017. He highlighted 
the Industry Workshop Agreement (IWA) which had proven to be a very important instrument in 
the early stages of development of a standard. He gave the example of IWA 11 on Clean Cook 
Stoves which had evolved in to the ISO TC  220. A US initiative on next generation toilets in IWA 24 
had also evolved in to ISO TC 305: Sustainable Non -sewered Sanitation System. Finally he 
mentioned a document under development in IWA 20 on understanding and applying drip 
irrigation for susta inable agriculture which was supported by Israel and Sweden.  
4.3.  The representative of South Africa  encouraged Members to review the list of pending 
observer requests as contained in the document G/TBT/GEN/2/Rev.12.  
5  REPORT (2016) OF THE  COMMITTEE ON TECHNIC AL BARRIERS TO TRADE  
5.1.  The Committee  adopted its 201 6 Report to the Council for Trade in Goods (G/L/11 67). 
6  DATE OF NEXT MEETING  
6.1.  The next regular meeting of the Committee is scheduled for 29-30 March 2017 . The full 
schedule of meetings is contained in JOB/TBT/ 212, issued on 25 November 2016. 
__________G/TBT/M/70  
 
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ANNEX  
SUMMARY REPORT OF EIGHTH  SPECIAL MEETING  
ON PROCEDURES FOR IN FORMATION EXCHANGE  
Pursuant  to its decision to hold, on a biennial basis, "regular meetings of persons responsible for 
information exchange, incl uding persons responsible for enquiry points and notifications"1, the TBT 
Committee held its Eighth  Special Meeting on Procedur es for Information Exchange on 
8 November  2016.2 The Special Meetings are organized to provide Members with an opportunity to 
discuss issues relating to information exchange and to review periodically the functioning of 
notification procedures and the operation of enquiry points. The m eetings are also used to follow 
up on decisions and recommendations agreed by the TBT Committee dur ing its triennial reviews. 
The Eighth  Special Meeting was organized in three panel sessions dealing with (i)  online 
tools;  (ii) functioning of enquiry points;  and (iii)  transparency in standard setting .3  
These  panel sessions were preceded by the official launch of ePing, a new global alert mechanism 
for TBT and SPS notifications, put together jointly by the WTO, ITC and UNDESA. This notification 
alert mechanism originated in the mandate given to this Committee in the 7th Triennial Review4, 
and responded to  a need to facilitate businesses, especially SMEs, in complying with TBT and SPS 
requirements by enhancing transparency. At the launch, the representative of UNDESA5 focused 
on the need to invest in sustaining the ePing initiative and further strengthening  the tripartite 
cooperation. He underscored the importance of ePing in light of the Sustainable Development 
Goals (SDGs), especially SDG 17 on global partnerships. The representative of the WTO6 
emphasised how enhanced transparency of SPS and TBT regulatio ns could help foster inclusive 
trade and the contribution that ePing would make to that goal. The representative of the ITC7 
highlighted the significance of ePing in light of the increasing number of SPS and TBT regulations 
disproportionally affecting SMEs . All three representatives underscored the successful and 
productive cooperation between the three organizations and the importance to keep working 
together  to make sure that ePing reached  its full potential.   
1  ONLINE TOOLS  
1.1  Tracking, respon ding and involvi ng stakeholders  
1.1.  The representative  of the Secretariat  introduced the newly -launched ePing system by 
recalling that this online tool facilitated the dissemination of SPS and TBT notifications from the 
WTO to the public and private sector and provided commun ication tools, at the domestic and 
international level.  The system aimed to enhance the awareness and understanding of SPS and 
TBT measures and to foster or increase cooperation among stakeholders, ultimately facilitating 
market access and avoiding trade d isruption. She highlighted the most prominent feature of ePing, 
notably the email alert service, which enabled stakeholders to subscribe to receive daily or weekly 
email alerts listing notifications targeting products and/or markets of interest, rather tha n having 
to browse all SPS and TBT notifications. Other features of the system were explored, including the 
easy-to-use search table, the possibility to download word versions of notifications as well as full 
texts of regulations or translations, export se arch results to an excel file, and save search filters. 
The system included both SPS and TBT notifications, and was available in the three official working 
languages of the WTO. An additional element of ePing was the Enquiry Point Management tool 
which aff orded Enquiry Point officials access to an additional set of functions allowing them to 
monitor national activity and to customize several features. Features of interest included: access 
to a list of all domestic subscribers; creation of contact groups; po ssibility to activate or deactivate 
domestic fora and the file sharing option at national level. The Secretariat representative  then 
                                                
1 G/TBT/1/Rev.10, page 35.  
2 The programme for the Special Meeting is contained in JOB/TBT/207/Rev.1 . 
3 Presentations made during the sessions are available on the TBT gateway page on the WTO website: 
https://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm  
4 On on -line tools, Members agreed to "request the Secretariat to explore the development of an e xport 
alert system for TBT notifications, in cooperation with other organizations" (G/TBT/37, para. 5.12).  
5 Mr. Lenni Montiel, UN Assistant Secretary -General.  
6 Mr. Karl Brauner, WTO Deputy Director -General.  
7 Ms. Arancha González , ITC Executive Director . G/TBT/M/70  
 
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  underlined that ePing was globally available and free of charge but that training and capacity 
building should be promoted at the domestic level to ensure that it could reach its full potential. In 
this context, the three organizations participating in this initiative, the UN, the WTO and ITC, had 
already committed to including ePing training in existing capacity building acti vities, and, 
depending on available funding, additional activities would be set up. She concluded by underlining 
that the cooperation between the three organizations had been formalized through a Memorandum 
of Understanding, signed at the highest level, an d subject to review within five years.  
1.2.  She proceeded to introduce the TBT -IMS modernization project currently being undertaken 
by the Secretariat, the TBT -IMS being a comprehensive database including all TBT notifications 
and TBT -related documents. The pro ject focused on two objectives: making the system more user -
friendly and creating more linkages between different sources of information. Amongst new 
improved features was the function of searches now being able to retrieve all related notifications, 
corresponding addenda, corrigenda and STCs. In addition, users could now search STCs by 
meeting and year; search full documents using keywords; and benefit from improved and more 
intuitive navigation buttons. She reported that a pilot version of the updated TBT -IMS was 
currently available and in a testing phase. Members were invited to use the test website and to 
share comments by the end of November in advance of the replacement of the current system 
scheduled for December.  
1.2  Piloting  and ongoing i mplementation of the WTO TBT/SPS Notification Alert System 
(ePing) in Uganda  
1.3.  The representative  of Uganda8 presented his delegation's experience as part of the ePing pilot 
project. He first recalled the mechanism to disseminate notifications prior to the introduction of  the 
ePing system. He underlined the main challenges of the old notification system, notably the weak 
communication link between members of national TBT/SPS Committee and stakeholders in 
relevant sectors, as well as the difficulty of accessing pertinent no tifications. He then outlined the 
phases of transition from the current notification system to implementation of the ePing system. 
He presented an overview of all the ePing -related events attended by Uganda and emphasized the 
lessons learnt from piloting a nd ongoing implementation of ePing, such as the need to address 
long-term sustainability and the need for more time to cover all ePing -related topics. Finally, he 
announced Uganda's proposals for promoting ePing, such as the introduction of an agenda item on 
ePing in regular meetings of national TBT/SPS Committee and the need for more training, 
promotion and awareness after the launch of the ePing system by the WTO Secretariat.  
1.3  The TBT IMS and ePing in Korea  
1.4.  The representative of the Republic of Korea9 outlined the structure of its TBT enquiry point, 
the Korean Agency for Technology and Standards regarding TBT issues ("KATS"), the hub of which 
is the Korean Information Management System for TBT Notifications known as Korean Network on 
World TBT ("KNOWTBT"). KNOWTBT mainly acted  as a comprehensive channel including support 
services for stakeholders to track and respond to TBT notifications. She summarized the role of 
related public and private actors, focusing on the Korean procedure for its response system to  TBT 
issues.  
1.4  Enhancing  business and government engagement through information exchange  in 
Australia  
1.5.  The representative  of Australia10 stressed the need to address non -tariff barriers (NTBs) as a 
matter of priority. She underlined the benefits of ePing in te rms of improved transparency, 
consultation and  accountability, all of which facilitated trade and which benefitted public agencies 
and private stakeholders alike. She described how the Australian Government was promoting 
ePing via various tools and events during which its benefits were stressed (e.g. enhanced 
informa tion about product requirements and the contribution  to the regulatory development 
process ). Finally, she referred to the Australian multi -stage approach towards NTBs and flagged 
some ideas to f urther enhance information exchange among Members.  
                                                
8 Mr. George Opiyo, TBT Enquiry Point.  
9 Ms Changin Ha, TBT Unit, Korea Conformity Laboratories . 
10 Ms Sophia Vincent, Departme nt of Foreign Affairs and Trade.  G/TBT/M/70  
 
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  1.5  The EU's experience in relation to involving stakeholders (private and public sector) 
in the processes of tracking and responding to TBT  notifications of other Members  
1.6.  The representative of the European U nion11 started off by showing the extensive involvement 
of stakeholders in TBT issues and the increasing number of notifications in the last decade. He 
outlined how the EU had dealt with this increase, presenting the motives for and the objectives of 
the ad  hoc TBT web platform (EC -TBT website). He explained in detail how the platform works and 
how the system had been made known to stakeholders. Finally, he focussed on third country 
notifications, highlighting the comments procedure and the tight cooperation  between the 
European Commission and stakeholders.  
1.6  Transparency and the Philippines  
1.7.  The representative of the Philippines12 underlined the importance of the "Philippine National 
Trade Repository" in its government's trade facilitation strategy. This web -based portal contributed 
to a more transparent trade environment , which would allow businesses easier access to 
information as well as the facilitation of compliance with prescribed regulations. Underscoring the 
importance of Good Regulatory Practice (GRP), s he outlined ongoing act ions engaged by the 
Philippines , such as the creation of an  oversight body that would review regulatory impact 
assessments. Finally, she took the example of the Philippine food sector to show how the use of 
technology could facilitat e transparen cy in this area of regulation.  
1.7  Experience of the USA TBT Enquiry Point Using a Notification Alert Service to 
Engage with Domestic Stakeholders  
1.8.  The representative of the United States13 outlin ed the various functi ons of the US TBT 
Enquiry Point a nd spoke about the benefits of the web -platform "Notify US" (i.e. receiving e -mail 
notifications of drafts or changes to technical regulations from WTO Members) . She u nderlined the 
extensive use of the alert service throughout the US  and concluded by refer ring to the new ePing 
alert service and suggested that as usage inevitably increased, challenges to stakeholders could be 
addressed by, inter alia , providing the full texts of new technical regulations when notified.  
1.8  Discussion  
1.9.  The representative of Malays ia asked how long it had taken Australia to fully transition from 
the old system to ePing.  
1.10.   The representative of Australia  replied that since the inception of the pilot phase, it had 
taken 12 months before being able to stop using the IMS system in a manua l way to alert 
stakeholders. The relatively long timeframe was attributable to the challenges faced in not leaving 
anyone behind  during this transition phase.  
1.11.   The representative of Trinidad and Tobago  noted that when they submitted notifications, 
they gene rally sent a link to the full text but despite this were always then asked to send the full 
text separately. She asked whether there was an advantage to the latter and whether there were 
any implications for copyright.  
1.12.   The representative of the United Stat es remarked that their enquiry point also received 
numerous requests for full text notifications, which often led them to think that they had forgotten 
to include the relevant link. She suggested that it would be worthwhile checking that these links 
did in  fact work and pointed out that any documents provided to the Secretariat would then be 
permanently available. She then noted that sometimes Members cited international standards 
which were indeed copyright protected and that in such cases, it would be adv isable to add a note 
to that effect, to name the standard, and, where possible, provide a link to where it could be 
purchased.  
                                                
11 Mr. Alessandro Polito, European Commission – Directorate -General for Internal Market, Industry , 
Entrepreneurship and SMEs . 
12 Ms Ann Claire Cabochan, Director of Bureau of International Trade Relations.  
13 Ms MaryAnn Hogan, U.S. Inquiry Point, National Institute of Standards and Technology.  G/TBT/M/70  
 
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  1.13.   The representative of the Secretariat  confirmed that two scenarios were current practice: 
the notification either contained a lin k to the full text on a server in the Member country, or to a 
WTO server, when a pdf copy of the full text had been provided.  
1.14.   The representative of Australia  noted with interest how different Members operated their 
enquiry points. She asked if the US Enqui ry Point operated with its trade ministry in matters 
relating to notifications and comments, as was the case in Australia, or whether these matters 
were dealt with solely within the enquiry point itself.  
1.15.   The representative of the United States  responded t hat its enquiry point was essentially a 
facilitator of communications, ensuring that everything that needed to be notified was notified and 
that on receipt of a foreign comment, all interested parties were made aware. The US Enquiry 
Point made information available to both industry and government but did not coordinate with the 
trade agencies on developing comments unless specific technical questions could be addressed. 
Based on information received from the US Enquiry Point, USTR was then able to coordinat e with 
industry to develop positions for WTO TBT Committee or for bilateral engagements.  
1.16.   The representative of Uganda , referring to the need for links to full texts, noted that his 
enquiry point was in the habit of sending a draft text to the Secretariat, who would provide a link 
to the text on disseminating the notification. On dissemination, his enquiry point would then check 
to confirm that the link was working. In spite of this, his enquiry point received frequent requests 
for the full text. He therefor e suggested that domestic stakeholders should be encouraged to check 
links contained in notifications in order to obtain draft text, in the absence of which an enquiry 
point or notification authority should then be contacted.  
1.17.   The representative of Brazil recalled that Uganda's presentation had nicely summed up the 
definition of a relevant notification: a combination of relevancy of product and of export 
destination. He therefore asked the Secretariat whether ePing allowed for cross -referencing of HS 
codes a nd trade data either from national databases or directly from the WTO.  
1.18.   The representative of the Secretariat  confirmed that upon registration, ePing allowed 
subscribers to identify HS and ICS codes and free text products, as well as markets of interest. 
Henceforth, whenever a notification matched either one or both of those criteria, it would be sent 
to the user via the email alert system.  
1.19.   The representative of CARICOM Regional Organization for Standards and Quality (CROSQ)  
asked what challenges SMEs encoun tered in reacting to notifications and how these challenges 
were overcome to enable to better participation in the multilateral trading system.  
1.20.   The representative of Uganda  observed, in this respect, that there seemed to be certain 
gaps in terms of the ca pacity of SMEs to analyse some of the technical texts referenced in 
notifications. He suggested helping these SMEs to build capacity in order to be able to perform this 
sort of analysis, or to bring trade lawyers on board on a needs basis in order to provi de comments 
on notifications.  
1.21.   The representative of Australia  underlined that SMEs constituted a major part of its 
domestic market – over 95% of all businesses – and were therefore of prime importance in the 
development of trade policy. To ease the burden that SMEs may face in participating in, and 
tracking, government and consultation processes, she suggested two adjustments: (i) to start 
including ePing in training programmes to increase awareness; and (ii) to use industry associations 
such as the Export Council of Australia to alleviate some of the burden by analysing trade barriers 
on behalf of SMEs.  
1.22.   The representative of the ITC voiced support for the positions of Australia and Uganda that 
access to information was a problem and suggested that in this r egard ePing could be beneficial. In 
addition, understanding the information itself could also prove difficult. He noted that not only was 
the absence of linguistic translations sometimes a problem, but also the translation of the legal 
language of notifica tions into business language that would make sense to SMEs. His suggestion 
was that SMEs could work with enquiry points in this respect and that business associations should 
also contribute to such capacity building.  G/TBT/M/70  
 
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  1.23.   The representative of Canada  acknowledg ed the positive aspects of ePing, to which it had 
registered, which included the user -friendly interface, the logical placement of icons, and the 
rapidity of becoming acquainted with the system. She considered the automatic email alert of 
utmost use, espec ially the possibility to customize it by product and export market, as pointed out 
by Uganda. She also welcomed the very efficient search filters, which she deemed superior to 
other engines used to search SPS and TBT -related material.  
1.24.   The representative o f Senegal  asked whether the US Enquiry Point submitted notifications 
on behalf of the US or whether it was the Notification Authority. He envisaged a potential problem 
of coordination and sought information on the situation in the US between the two bodies .  
1.25.   The representative of the United States  replied that the US Enquiry Point and Notification 
Authority happened to be in the same place and staffed by the same people and therefore 
coordination was not an issue. In cases of borderline measures, contact wa s made with the office 
of USTR to review the measure but no formal coordination was needed.  
1.26.   The representative of Trinidad and Tobago  added to Senegal's query by explaining that its 
enquiry point was housed at the Bureau of Standards. The enquiry point was  charged with 
preparing notifications, and then sending it through its notification authority, the Ministry of Trade 
and Industry, who in turn submitted it to the WTO via the Geneva -based mission. This process 
posed a problem in that once the notification left the enquiry point, it was hard to know when it 
would be submitted to the WTO and could sometimes take 28 days, in turn hampering the 60 -day 
comment period. In this respect, the newly developed NSS removed such time constraints as 
notifications were se nt directly to the WTO.  
1.9  Submission of notifications  
1.27.   The representative of the Secretariat  updated the Committee on the TBT Notification 
Submission System (TBT NSS), the online platform for Members to prepare and submit TBT 
notifications to the WTO. He not ed with pleasure that Members' use of the TBT NSS had increased 
every year since the end -2013 launch of the system. To illustrate this point, he reported that in 
2014, 35% of all TBT notifications were submitted through the TBT NSS, and from 23 Members; in  
2015, figures were up to 52% of notifications, by 26 Members; and in 2016, 61% of notifications 
for 33 Members. Whilst a total of 38 Members had already signed up to use the system, it was 
hoped that this number, as well as the share of notifications rece ived via the TBT NSS, would both 
further increase. The benefits of such an increase would be two -fold: from the Secretariat's point 
of view, the use of the NSS facilitated the processing of notifications, in terms of speed (four times 
faster, with obvious implications for respecting the comment period) and accuracy; for Members 
using the system, feedback had shown that the tool helped towards the organization and tracking 
of submitted notifications, also facilitating coordination between ministries. He conc luded by urging 
more Members to sign up to this online system.  
1.28.   The representative of Canada  reported that its enquiry point had been using the NSS for 
three years and recognized the value and reliability of the tool. She outlined the benefits in terms 
of faster processing of notifications by the Secretariat, which in turn gave Members more time to 
become informed and for interested parties to submit comments. Canada's specific situation as a 
bilingual country with two official languages was adequately conte mplated by the system. There 
were, nonetheless, some disadvantages, such as the rejection by the system of certain characters 
as well as the absence of a mechanism to withdraw a notification in case of errors or omissions. 
Her delegation looked forward to continued improvements to the system based on feedback from 
interested parties.  
1.29.   The representative of the United States  highlighted the benefits of the NSS over the old 
method of emailing word documents to the Secretariat. Responding to concerns raised by  Senegal, 
as well as by Uganda in the past, she addressed the issue of coordination between one or two 
agencies before notifying. In this respect she noted the possibility of applying for more than one 
password to allow for coordination between multiple ag encies. In effect, templates could be put on 
hold, allowing another agency to review prior to submission.  
1.30.   The representative of the European Union , despite a general view that the system worked 
well, expressed a few reservations. He said that when texts w ere too long, or contained many G/TBT/M/70  
 
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  images, they had to be sent in parallel, by email. He also requested that the Secretariat inform 
Members in advance on which days the WTO would be closed in order to plan ahead and respect 
60-day transparency obligations.  
1.31.   The representative of Kenya welcomed the faster and reliable NSS system. On the issue of 
coordination, he stated that once the enquiry point had completed the preparation of the 
notification, their notification authority was alerted that they could notify im mediately, thus 
removing the challenge of delays to processing.  
1.32.   The Chairperson  wrapped up the session on online tools by encouraging Members to: (i) 
test the modernized TBT -IMS; (ii) start using ePing and the NSS; and (iii) look at the job 
document overv iewing online tools.14 
2  FUNCTIONING OF ENQUIRY POINTS 15 
2.1  Internal coordination and handling of comments  
2.1.  In the Seventh Triennial Review, the Committee had recommended continuing discussions on 
the role of enquiry points in facilitating internal coordination a nd in the handling of comments and 
exploring ways to improve their functioning.16 
2.1.1   The EU's experience in relation to the role of enquiry points in facilitating internal 
coordination and in the handling of comments  
2.2.  The representative of the European Union17 presented the functioning of the TBT notification 
procedure within the EU. He outlined the internal procedure within the European Commission 
services for the notification of new EU draft technical regulations, also recalling the obligations of 
EU member Sta tes when notifying new national technical regulations to the Commission. He 
concluded by pointing out that in case of comments from third countries the reply would come 
directly from the EU, as per the European common external trade policy.  
2.1.2   Chinese Taipei : Building Constructive Working Relationship with Regulators  
2.3.  The representative of Chinese Taipei18 outlined the objectives of its national TBT Enquiry 
Point. She then indicated the various regulatory authorities involved in the notification process, 
and the  ways its Enquiry Point maintained connections between them via preparatory work before 
WTO TBT Committee Meetings (e.g. overviews of STCs or the review of notifications already 
submitted) and the delivery of seminars on transparency. Finally, she highligh ted how the national 
Enquiry Point enhanced coordination among regulators.  
2.1.3   Discussion  
2.4.  The representative of Switzerland  said that having a unit within its administration screening 
all legislative projects, assessing relevancy for trade and TBT, and ensurin g notification took place, 
was equally possible in the European Commission and Switzerland. He asked whether other 
Members had something similar in place to ensure consistency with TBT notification obligations.  
2.5.  The representative of South Africa  said that a list of contact persons in different regulatory 
departments should be maintained. He asked whether Chinese Taipei maintained a contact list 
presenting just one contact person, or the contact point of each regulatory division in that 
department.  
2.6.  The repr esentative of the United States  asked what would happen if ever a regulator did not 
want to notify a measure, for example if there was low awareness. She asked whether in such a 
case Chinese Taipei would provide assistance.  
                                                
14 JOB/TBT/210.  
15 G/TBT/37, para. 5.12. 
16 G/TBT/37, para. 5.1 2.a.i. 
17 Mr. Alessandro Polito, European Commission – Directorate -General for Internal Market, Industry, 
Entrepreneurship and SMEs . 
18 Ms Chuan -Shu Cha, Bureau of Standards, Metrology & Inspection . G/TBT/M/70  
 
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  2.7.  The representative of Uganda  added that it was a challenge to empower notification 
authorities and enquiry points to be able to identify draft regulations that probably met notification 
requirements.  
2.8.  The representative of Malaysia  asked whether Chinese Taipei had encountered instances of 
duplication of a regulation, or whether there was ever a "no -man's land" with no regulation 
regulating that area.  
2.9.  The representative of Australia  asked whether in workshops and seminars, regulators were 
educated in following, receiving, and making comm ents on notifications. She was interested in 
knowing to what extent regulators became involved in the comment -making process and whether 
most comments came from regulators, stakeholders or from ministries.  
2.10.   The representative of South Africa explained thei r system of coordination. A domestic TBT 
committee brought regulators and technical quality infrastructure bodies together to share 
experiences, normally just prior to TBT Committee meetings in order to discuss the annotated 
agenda and STCs. For the notifi cation of draft regulations, regulators always mentioned that their 
mandate was under a specific act of parliament or legislation. The response of South Africa would 
always be that a notification authority was a country and therefore a Member of WTO, and a s such 
all regulators were indirectly WTO Members, having to comply with TBT obligations.  
2.11.   The representative of Canada  underlined the importance for trading partners of the work of 
enquiry points in collecting and disseminating information. This ensured t hat observations made by 
Members on notifications were dealt with efficiently. She then outlined the process of dealing with 
comments within the Canadian authorities.  
2.12.   The representative of Chinese Taipei  in response to South Africa said that they had 15 
regulatory authorities and just one contact person for each regulator, the person responsible for 
internal coordination (so 15 contact persons). On resistance to notify, she said that in such cases 
they would give assistance by showing the regulator similar notifications made by other Members 
to help persuade them of the necessity to notify. On possible duplication of notifications, she 
answered that when regulators notified, they would know if there was any duplication or not and 
therefore there were no such  cases. Nor were there any cases of areas with no regulations in 
place. On Australia's question, she replied that all regulators participated in seminars during which 
they would be provided with samples of formats for commenting. She confirmed that most 
comments came from regulators.  
2.2  Capacity Building and Training  
2.13.   In the Seventh Triennial Review, the Committee had recommended exploring ways to 
improve the functioning of the Enquiry Points by addressing capacity building needs of developing 
Members.19 Member s had also requested the Secretariat to prepare a guide on best practices for 
enquiry points based on experiences shared by Members and for the purposes of training and 
capacity building.20 
2.14.   The representative of the Secretariat  updated the Committee on the status of the Enquiry 
Points guide, which was being developed in response to the mandate of the Seventh Triennial 
Review.21 She recalled that an online survey of enquiry points had been developed, which would 
be used to gather information to assist in the p reparation of the guide, scheduled for conclusion 
during 2017, and that it was available online for completion by Members' Enquiry Points. 
Information on how to participate in the survey was available in the room document on TBT Online 
Tools.22 She reported  that to date, 32 Members had requested their password for the survey, 10 of 
whom had completed it. The Secretariat looked forward to greater participation from Members, 
and encouraged those who had not done so to complete the survey.  
                                                
19 G/TBT/37, para. 5.12.a.i.  
20 G/TBT/37, para. 5.12.a.i i. 
21 G/TBT/37, para. 5.12(a)(ii).  
22 JOB/TBT/210 . G/TBT/M/70  
 
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  2.2.1   US Technical Assista nce to TBT Enquiry Points and Notification Authorities in 
Africa  
2.15.   The representative of the United States23 presented the African countries benefitting from 
technical assistance provided by Standards Alliance, explaining the main focus as being capacity 
building for enquiry points and notification authorities. The development of customized action 
plans was aimed at improving the effectiveness of these bodies, mainly in terms of enhanced 
communication with stakeholders and promotional events. Finally, she deta iled the key elements 
of subsequent on -site training.  
2.2.2   Discussion  
2.16.   The representative of Australia  asked whether capacity building events included SPS enquiry 
points and how other donors of technical assistance explained the differences between SPS and 
TBT.  
2.17.   The representative of Kenya  expressed appreciation for the in -depth training received from 
the Standards Alliance which had enabled them to set up a notification alert system similar to 
ePing.  
2.18.   The representative of South Africa  pointed out that its TBT e nquiry point officials had a wide 
range of backgrounds, from lawyers to librarians to administrators, and asked the US what they 
considered an appropriate qualification for such a task. On this point, the representative of 
Australia shared their experience  that attention to detail and document management were critical, 
as well as knowing who and how to consult so that all relevant experts could provide input.  
2.19.   The representative of Brazil  asked whether capacity building activities only covered 
assistance in  preparing notifications or whether it also helped countries to understand and 
comment on third party notifications.  
2.20.   The representative of Senegal  commented on the elaborate nature of the action plans 
described by the US in their presentation and asked wh at the deadlines and timing were in 
drawing them up.  
2.21.   The representative of Malawi , a beneficiary of the Standards Alliance programme, said that 
the activity had improved awareness of TBT to stakeholders in both private and public sectors. In 
particular th ey had realised that an enquiry point could be run by relatively few people, an 
important point for a smaller economy like Malawi.  
2.22.   The representative of Canada  informed the Committee of its intended capacity building 
activities with a standards -setting bod y in Trinidad and Tobago which would consist of 
representatives visiting the Canadian notification authority and enquiry point to observe operations 
in order to boost transparency, conformity and good regulatory practices. Other elements of 
training would examine the national quality infrastructure, the development of technical 
regulations, and conformity assessment procedures.  
2.23.   he representative of Canada  informed the Committee of its capacity building activities with a 
standards -setting body in Trinidad an d Tobago which would consist of representatives visiting the 
Canadian notification authority and enquiry point to observe operations in order to boost 
transparency, conformity and good regulatory practices. Other elements of training would 
examine, inter a lia: legislation, legal documentation required to implement technical regulations, 
calculation of costs and benefits of technical regulations, and conformity assessment procedures.  
2.24.   The representative of the United States  replied that the scope of their agr eement only 
covered TBT -related assistance but that future events would target SPS enquiry points. On the 
question related to appropriate qualifications for working in an enquiry point, she said that she was 
herself a librarian by training and that this se rved well in dealing with the documents and 
metadata involved. On the scope of capacity building activities, she replied that the bulk of 
activities were related to the preparation and submission of notifications but that an equally 
                                                
23 Ms Leslie McDermott, Director, International Development, American National Standards Institute.  G/TBT/M/70  
 
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  important element was t he discussion of stakeholder engagement and national coordination, as 
was preparing support for national level committees. During these activities, best practices were 
shared in order to produce effective comments. On Senegal's question on action plans, sh e replied 
that timelines were relatively short as they were developed in one to two months, followed by 
onsite training as soon as possible after conclusion. This timeline could vary depending on levels of 
coordination and communication.  
2.25.   The Chairperson un derscored the importance of education and training in raising awareness 
and in enhancing the functioning of enquiry points.  
3  TRANSPARENCY IN STANDARD SETTING24 
3.1.  In the Seventh Triennial Review, consistent with paragraphs J and L of the Code of Good 
Practice, the Committee had encouraged Members' central government standardizing bodies and 
non-governmental bodies which had accepted the Code to (i) publish their work programmes on 
websites and notify the specific website addresses where the work programmes are p ublished to 
the ISO/IEC Information Centre; and (ii) share information about the publication of a notice 
announcing the period for commenting on a draft standard.25 The Committee had also 
recommended discussing ways of improving Members' access to the infor mation on the above -
mentioned points concerning transparency in standard setting.26 
3.1  Japan's Action following the 7th triennial review -Transparency in standard -setting  
3.2.  The representative of Japan27 highlighted some problems encountered in using the "WTO TBT 
Standards Code Directory". He then recalled some of the outcomes of the 7th triennial review, 
such as the recommendation to share information about the publication of notices announcing the 
comment period on a draft standard, or discussion on ways of impro ving Members' access to 
relevant information. He then explained how the Japanese Industrial Standards Committee 
planned to implement those recommendations, in particular the possibility offered by the new 
system to notify the specific website addresses whe re the work programmes were published to the 
ISO/IEC Information Centre.  
3.2  WTO -ISO Standards Information Gateway  
3.3.  The representative of the Secretariat  updated the Committee on the WTO's collaboration with 
the International Standardization Organization (ISO) on the WTO -ISO Standards Information 
Gateway. He recalled that in pursuance of a recommendation made by Ministers in a 1994 
Marrakesh Ministerial Decision, in 1995 the Secretariats of the WTO and ISO had entered into a 
MoU establishing the "WTO Standards I nformation Service" to be operated by the ISO Central 
Secretariat. This service was intended to provide information about: standardizing bodies that had 
accepted or withdrawn from the Code of Good Practice28; and the work programmes these bodies 
must publis h at least every six months.29 Specific notification templates had been drawn up both 
for notifications of standards to the ISO directly, but also to the WTO. ISO had since published 
information annually on this, regularly noted by the Committee at its Marc h meetings.  
3.4.  He stated that in retrospect, while the notification requirements for technical regulations and 
CAPs had functioned very well, in general less information about standards  was available. This 
could be attributable to the difference between noti fication requirements for technical regulations 
(and CAPs ) and those for standards . In this respect, he highlighted three recommendations 
currently before the Committee with respect to transparency on standard -setting contained in its 
7th Triennial Review:   
a. encourage Members' central government standardizing bodies, and non -governmental 
bodies that have accepted the Code, to publish their work programmes on websites and 
                                                
24 G/TBT/37, para. 4.10.  
25 G/TBT/37, paras. 4.10.b .i and 4.10.b.i i. 
26 G/TBT/37, para. 4.10.b.iii.  
27 Mr. Takatoshi Yamamoto, Office for Economic Partnership for Standards and Conformity Assessment 
& JISC Secretariat, Ministry of Economy, Trade and Industry . 
28 TBT Agreement , Annex 3, Para. C . 
29 TBT Agreement , Annex 3, Para. J . G/TBT/M/70  
 
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  notify the specific website addresses where the work programmes are published to the 
ISO/IEC Information Centre (paragraph J);  
b. encourage Members' central government standardizing bodies, and non -governmental 
bodies that have accepted the Code, to share information about the publication of a 
notice announcing the period for commenting on a dr aft standard (e.g. title and volume 
of publication, website address) (paragraph L);  
c. to discuss ways of improving Members' access to the information mentioned in the above 
paragraphs.  
3.5.  He announced that as part of this process, and spurred by these recent recommendations, 
discussions with the ISO Secretariat had been set in motion on how to enhance the service to 
Members. To this effect, a new gateway for this information had been developed by the ISO30, 
setting out information on standardizing bodies that h ad accepted the Code of Good Practice and, 
where available, their work programmes. It also contained the WTO forms for the acceptance, 
withdrawal and notification of work programmes. With respect to hyperlinks to the source of this 
information, it had beco me apparent that it was often too general (i.e. link solely to homepage) or 
outdated (pdf files); moreover, sometimes links were broken. Members' central government 
standardizing bodies and non -governmental bodies were therefore encouraged to review 
inform ation about their work programmes and to provide any corrections directly to the ISO.31 
3.6.  The representative of the United States  reported issues with ISONET with respect to the 
working of the website as ANSI had not been able to notify to ISONET for several years due to, 
inter alia, broken links. She asked if other Members had encountered similar problems, and if so, 
how they were submitting their work programmes to the information centre.  
3.7.  The representative of ISO expressed his organization's satisfaction wi th the collaboration with 
WTO. He reported on the joint -resource database that had recently been developed to enhance the 
sharing of information on standards : https://tbtcode.iso.org/ . His organization made themselv es 
available to the standardization community for any support necessary in the use of this service.  
 
 
__________  
                                                
30 https://tbtcode.iso.org  
31 tbtcode@iso.org