RESTRICTED  
  
G/TBT/M/77  
 
 
15 May 2019  
(19-3400) Page: 1/46 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETI NG OF 6-7 MARCH 2019  
INTERIM CHAIR PERSON : MR. JOSE MANUEL CAMP OS ABAD  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ ...........  1 
2   STATEMENTS FROM MEMBERS UNDER ARTICL E 15.2 ................................ ...... 1 
3   SPECIFIC TRADE C ONCERNS (STCS)  ................................ ..............................  2 
3.1   Reported resolutions  ................................ ................................ .......................  2 
3.2   Withdrawn concerns  ................................ ................................ .......................  2 
3.3   New concerns  ................................ ................................ ................................  2 
3.4   Previously raised concerns  ................................ ................................ .............  11 
3.5   Exchange of Experiences  ................................ ................................ ...............  45 
4   TWENTY -FOURTH AN NUAL REVIEW  ................................ .............................  46 
5   TECHNICAL COOPERATION ACTIVITIES  ................................ .......................  46 
6   UPDATING BY OBSE RVERS  ................................ ................................ ...........  46 
6.1   Pending requests  ................................ ................................ ..........................  46 
7   ELECTION OF THE CHAIRPERSON  ................................ ................................ . 46 
8   DATE OF NEXT MEETING ................................ ................................ ...............  46 
 
1  ADOPTION OF THE AGEN DA 
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 13. 
2  STATEMENTS FROM MEMB ERS 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 provision was contained in an annex to th e Annual Review of 
the Implementation and Operation of the TBT Agreement ( G/TBT/42), issued on 25 February 2019 . 
Information on the list of statements is available on the TBT Information Management System  (TBT 
IMS). 
2.2.  The representative of Canada  informed the Committee that Canada's  Cabinet directive on 
regulation had recently entered into force . This  document set out the G overnment's expectation and 
requirements in the development, the management and the review of federal regulations. The 
strength of Canada's regulatory system was recognized by the OECD and this new directive buil t on 
its strong foundation by emphasising a lifecycle approach to the development, management and 
                                                
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/77  
 
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  review of regulations. The principle of openness and transparency throughout the regulatory lifecycle 
was fundamental to GRP. Regulators had to engage stakeholders early, often and throughout the 
development, management and review of regulations in Canada. These requirements meant  that 
regulators work ed with the foreign ministry to notify trading partners of chan ges to regulations which 
could impact trade . The directive was also expected to help small business by lowering the 
administrative burden and cost. More rigorous  cost benefit analysis coming from the directive would  
ensure regulators d id seek to lower thos e costs and impacts on small businesses when developing 
regulations. The new policy require d that departments and agencies were to conduct a review of 
their existing regulatory stock to ensure that regulations continue d to meet their intended policy 
object ives sufficiently and effectively . Canada maintain ed a one -for-one rule which mean t that as 
new regulations were brought in, older ones which no longer met their intended objectives c ould be 
removed. Canada also s ought  regulatory cooperation be emphasised in this new policy so as to f oster 
international trade , to reduce trade barriers and to provide consumers with greater choic e. 
Therefore, when proposed regulations or standards were different from international practice , those 
of other jurisdictions  or trading partners, Canadian regulators were required to explain the difference 
and reasoning in the publicly available regulatory impact analysis statements which would 
accompany all regulatory proposals.  
3  SPECIFIC TRADE CONCE RNS (STCS)  
3.1.  The Chairperson  informed the Committee that lengthy statements would be prepared for 
circulation separately  and referred to in the minutes (see paragraph 3.4 below for an example) . He 
said that this was done because such statements were often technical and difficult to s ummarize 
without compromising accuracy and detail. At the last m eeting, 42 statements had been circulated  
this way; this had  significantly expedited the pre paration of the minutes. Prepared s tatements would 
be sent to delegations for check ing prior to  circulation.  
3.1  Reported resolutions  
3.2.  There were no reported resolutions.  
3.2  Withdrawn concerns  
3.3.  The Chairperson  reported that the following STC s had been withdrawn from the agenda at the 
request of the concerned Member:  
a. China IT banking equipment ;  
b. GCC handling of E nergy drinks . 
3.3  New concerns  
3.3.1   Israel - Bill on the Restriction on Advertising and Marketing of Tobacco Products 
(Amendment No.7, 5778 -2018)  G/TBT/N/ISR/730  (IMS ID 5732) 
3.4.  The representative of the Dominican Republ ic raised concerns with Israel's bill on the restriction 
on advertising and marketing of tobacco products . The full statement is contained in G/TBT/W/603 . 
3.5.  The representative of Canada  expressed interest in the ongoing international developments 
regarding tobacco control measures, and the interaction of such measures with both in ternational 
trade and public health. He said that tobacco use was a significant problem, in Canada and around 
the world. In Canada alone, 45,000 people died annually as a result of smoking – a leading cause 
of preventable death and disease. Tobacco product s were also the only good to be the subject of a 
legally binding health treaty, the World Health Organization Framework Convention on Tobacco 
Control. Tobacco packaging and the products they contain were powerful promotional vehicles. 
Research had shown th at plain tobacco packages reduced their appeal and attractiveness, especially 
among youth.  
                                                
2 For previous statements follow the thread under IMS ID 573  (under dates raised and references) . G/TBT/M/77  
 
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  3.6.  The Government of Canada committed to introduce plain packaging requirements for tobacco 
products, similar to those of Australia and the United Kingdom, publishing p roposed regulations in 
June 2018. These requirements were an expression of the right to regulate in the interest of public 
health in Canada. Canada supported the Panel Report findings in the Australia -Tobacco Plain 
Packaging  dispute, which, he said, confir med that WTO Members had regulatory flexibility to take 
legitimate public health measures, such as plain packaging measures for tobacco products. Indeed, 
many countries had implemented plain packaging requirements or were considering similar 
measures to pr otect the health of their citizens.  
3.7.  The representative of Israel  said that the Law proposal had been notified to the TBT Committee 
in January 2014 as notification G/TBT/N/ISR/730 . One of the major changes in the proposal was the 
change in the name of the law as well as in many of the paragraphs from referring only to "tobacc o 
products " to "tobacco and smoking products ". The proposal defined "smoking products " which also 
included cigars. Furthermore, in paragraph 11 of the Law proposal it was stated that the Minister of 
Health was allowed to set regulations on the design of pa ckaging of tobacco or smoking products. 
She recalled that at the time, Israel had received a letter from the Dominican Republic setting out 
their various concerns that the Law proposal would "…allow the Minister of Health to mandate a 
unified pack design f or tobacco products… ", including concerns over the removal of all design 
elements of trademarks and geographical indications from tobacco products and the risk that by 
"…eliminating the valuable differentiating role performed by trademarks and geographical  
indication… " it may result in a higher consumption and more illicit trade in tobacco goods. In addition, 
the Dominican Republic had urged Israel to delay the adoption of a plain packaging measure for 
tobacco products until the issuance of the final panel report to the parties in Australia — Tobacco 
Plain Packaging . The report had been circulated on 28 June 2018.  
3.8.  In light of  the above, her delegation was of the opinion that Israel had provided trading partners 
with the opportunity to transmit their concerns and comments regarding the packaging measures 
and that trading partners had availed themselves of this opportunity. Isra el had indeed taken into 
consideration the comments received and the recommendations of the Panel in the above -mentioned 
report, in finalizing the measure. The measure had recently been adopted and published, with a one -
year implementation period in order to allow trading partners to make the necessary adjustments.   
3.3.1.1   Trinidad and Tobago - Regulation related to the prohibition, of commercialization 
and importation of plastic products of polystyrene  (IMS ID 5743) 
3.9.  The representative of the Dominican Republic  said that on 27 July 2018, the Government of 
Trinidad and Tobago had announced the prohibition of the marketing and importation of polystyrene 
plastics, through the Minister of Planning and Development. The ban included cups and food 
containers, as well a s plates, drinking straws and other utensils, and would be implemented in 2019. 
It was her delegation's understanding that the measure could be defined as a technical regulation 
under Annex 1.1 of the TBT Agreement, as it laid down certain characteristics with which compliance 
was mandatory, by providing that exports of plastic products must not be made from polystyrene. 
The Dominican Republic considered the measure to be more restrictive than necessary, in 
contradiction with the provisions of Article 2.2 o f the TBT Agreement. Furthermore, the measure 
was deemed contrary to Article 2.1 of the Agreement, as it would have a harmful effect on imports 
of polystyrene products. She stated that in this regard the measure was inconsistent with the 
provisions of Arti cle III:4 of GATT 1994 and not justified by Article XX(g); rather, it was a disguised 
restriction on international trade. As the measure had not been notified to the TBT Committee, her 
delegation was also concerned that it contradicted the transparency pro visions established under 
the TBT Agreement. Trinidad and Tobago was asked to provide information on the stage reached in 
the preparation of the legislation, and to notify the measure, with adequate notice, in order to receive 
and take into account the com ments and concerns of the affected Members.  
3.10.   The representative of Trinidad and Tobago  stated that the notice was currently not in force 
and that the details were being finalized, including the scope of the ban. The proposed measure 
would be notified to the  WTO via the enquiry point once details were finalized. She said that the 
notification would include a proposed date of entry into force and that her delegation intended to 
provide trading partners with the necessary information once it was confirmed to en able them to 
adapt to the new legislation.  
                                                
3 For previous statements follow the thread under IMS ID 574  (unde r dates raised and references) . G/TBT/M/77  
 
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  3.3.1.2   European Union - Draft Commission Regulation laying down eco -design 
requirements for electronic displays pursuant to Directive 2009/125/EC of the European 
Parliament and of the Council, amending Commission Regulat ion (EC) No 1275/2008 and 
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes)"  
G/TBT/N/EU/609  (IMS ID 5754) 
3.11.   The representative s of China  and the United States  raised concerns with the EU's Draft 
Commission Regulation laying down eco -design requirements for electronic displays pursuant to 
Directive 200 9/125/EC of the European Parliament and of the Council, amending Commission 
Regulation (EC) No 1275/2008 and repealing Commission Regulation (EC) 642/2009 (and its 
accompanying annexes) . The full statement s are contained in G/TBT/W/616  and G/TBT/W/606 , 
respectively . 
3.12.   The representative of Japan  expressed appreciation for the EU's policy to improve the energy 
and resource efficiency of energy -related pr oducts. However, having watched closely the impact of 
the eco -design requirements of electronic displays on domestic industries, Japan was deeply 
concerned that the latest draft regulation contained significant changes not present in the draft 
regulation n otified to the TBT Committee in October 2018. Of particular concern was that the 
introduction of a ban of all halogenated flame retardants (HFRs) and the requirements on "Spare 
Part Availability and Delivery Time " to the latest draft which he said greatly impacted Japanese 
industries. His delegation requested that the EU notify the revised draft and consider opening a new 
comment period when there were significant changes from a notified draft regulation. He said that 
the new eco -design regulations would ha ve a major impact on trade in the electric and electronics 
products and therefore requested that the EU ensure that the regulations be established in a 
transparent process and not pose unnecessary trade barriers.  
3.13.    The representative of the European Union  noted that on 9 October 2018 the EU had submitted 
the notification in question allowing for a 60 -day comment period. Comments had been received 
from Japan, Korea and the US. The Ecodesign Regulatory Committee (ERC) had met on 18 December 
to discuss and vo te on the Commission proposal. He said  that in the context of comitology procedures 
set out in Regulation (EU) 182/2011 ("Comitology regulation"), committee members representing 
member States had the opportunity to suggest amendments to the Commission draf t and that the 
chair may present amended versions of Commission draft implementing acts, to endeavour to find 
solutions commanding the widest possible support within the committee. The Commission had done 
so on a number of ecodesign measures currently unde r discussion, including the partial restriction 
on the use of halogenated flame retardants. The text, as voted, was now in the scrutiny period. He 
stated that the regulation would repeal the previous Ecodesign legislation on televisions and TV 
monitors in force since 2010 and would extend the scope to other electronic displays, such as 
computer monitors. The review included, on top of energy efficiency requirements updated to the 
technology evolution, new "circular economy" requirements for increasing durab ility and improving 
reparability and for improving the efficiency of the recycling process and the yields of recoverable 
materials.  
3.3.2   China - Cosmetics Supervision and Administration Regulation (Draft) 
G/TBT/N/CHN/1310  (IMS ID 5765) 
3.14.   The representative of Japan  appreciated the classification with respect to new ingredient 
application procedures in the draft regulation but noted that other concerns had not been improved 
or clarified. First, the scope of disclosure for new ingredients in article 9 should explicitly exclude 
confidential company information. Second, article 15 rega rding online publication of the scientific 
basis of efficiency claims should be reconsidered, because efficacy evaluation materials contain 
confidential company information. In this context, she further requested that the text explicitly 
accept testing dat a from laboratories outside China or internal to the company. Third, article 38 's 
requirement of consistency between Chinese labels and original labels should be reconsidered, 
because the original labels were designed to comply with, often different, count ry of origin 
regulations. Fourth, she noted that whereas the draft regulation note d the responsibility for quality 
and safety of multiple stakeholders, such as "cosmetics producers and operators " and "cosmetics 
registrants or filers ", Japan requested that article 6 only require one responsible legal or natural 
person inside China and that label requirements regarding producers in article 39 should be 
                                                
4 For previous statements follow the thread under IMS ID 575  (under dates raised and references) . 
5 For previous statements follow the thread under IMS ID 576  (under dates raised and references) . G/TBT/M/77  
 
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  removed. Fifth, she noted that China 's current practice of requiring animal testing documentation 
only for i mported products amounted to discriminatory treatment according to the WTO rules, and 
that Japan requested for article 13 to reflect equal treatment of imported products. Lastly, Japan 
requested China to provide an adequate grace period of at least one yea r for implementation to 
avoid confusion in the market.  
3.15.   The representative of the Republic of Korea  expressed concern over article 15 of the draft 
regulation requir ing publication of evidence supporting efficacy claims on a website designated by 
the National Medical Products Administration (NMPA). Recalling Article 5.2.4 of the TBT Agreement, 
he stated that it was inappropriate to demand public access to evidence which may contain 
confidential business information and that the provision should therefore be amended to allow for 
direct submission of evidence to NMPA where necessary. In addition , he asked that article 38 be 
amended to deem over -labels in Chinese that were accurate and complete in content and compl ied 
with the Chinese cosmetics labelling requirements be sufficient. He expressed concern that requiring 
over-labels to be consistent with the original labels would be trade -restrictive and impose additional 
adminis trative burdens. Lastly, Korea asked China to provide enough transitional period and asked 
for other relevant information including the date of the draft regulation 's entry into force.  
3.16.   The representative of the United States  requested China, first, to clo se the gap on timing 
differences for market authorization for imported products versus domestic products. Second, she 
asked China to use international standards, including from ISO, ASTM International, and NSF 
International, and to consider ISO 22716:2007,  "Cosmetics - Good Manufacturing Practices (GMP) - 
Guidelines on Good Manufacturing Practices, " as well as ingredient, product safety and claims 
assessment. She noted that the draft regulation did not incorporate these standards by reference or 
demonstrate d their consideration. Third, she asked China to consider the principles and 
recommendations developed by the International Cooperation on Cosmetics Regulation (ICCR). 
Fourth, she requested more specific information on what product filing requirements and other 
administrative measures may demand the disclosure of CBI, including ingredient filings, product 
efficacy claims, and adverse events reporting. She noted that the provisions in the draft regulation 
indicated governmental publication of this informatio n, whereas regulators in the United States, 
European Union, and other markets generally did not require such full disclosure —only requesting 
additional information should there be an adverse event which companies were then required to 
provide, usually with in 72 hours, via their authorized in -country representative. Lastly, she thanked 
China for notification G/TBT/N/CHN/1311  of a draft measure providing information on testing and 
filing requirements for both imported and domestically produced cosmetics.  
3.17.   The representative of the European Union  welcomed the draft regulation b eing based on the 
principles of modern cosmetics legislation and aligning with global regulatory trends. She noted that 
the measure allow ed China to address some key concerns and barriers arising from the current 
legislation that Members ha d raised repeate dly in TBT discussions. These concerns include d the lack 
of approval of new cosmetic ingredients, the discriminatory management of imported versus 
domestic non -special products, a potentially mandatory Chinese packaging brought by a ban of over -
stickering of original labelling, as well as the mandatory requirement to carry out unnecessary animal 
tests on finished cosmetic products imported to China. She noted that the draft regulation aim ed to 
address these issues directly or at least provid ed the framework  to address them in ensuing 
implementing measures. In this context, the EU noted the importance of implementing measures to 
follow the draft regulation 's principles and intentions to ensure high compatibility with trading 
partners, high levels of consumer protection, and facilitation of industry development and 
international trade. Lastly, the representative asked China to explain the state of play of the new 
draft Cosmetics Supervision and Administration Regulation and to indicate the planned timeframe 
for its adoption.  
3.18.   The representative of China  stated that the purpose of the draft regulation, which had been 
notified, was to respond to developments in China 's cosmetics industry. She expressed the need to 
study Members ' concerns and respond at a later time . G/TBT/M/77  
 
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  3.3.3   Republic of Korea - Warning statement and graphic health warnings on alcoholic 
beverages  (IMS ID 5776) 
3.19.   The representative of the United States  expressed full support for the objective of managing 
the public health challenges related to drunk driving. However, her delegation was concerned by the 
lack of transparency in the development of the proposed amendments to Korea's Public Health 
Promotion Act. It was also noted that many aspects of the measure were currently unclear, including 
the timeline for implementation and the technical requirements for the new labels which could result 
in an unnecessary disruption to trade in US alcohol beverage prod ucts to Korea. In December 2018, 
the US had requested via the TBT Enquiry Point that Korea notify the revisions under consideration 
to its Public Health Promotion Act, including the details of its new graphic warning label requirements 
for beverage alcohol . She noted that Korea had not notified the amended measure and asked Korea 
to commit to doing so before adoption.  
3.20.    The representative of the Republic of Korea  reported that the preparation of the notification 
was in process and committed to keep consultin g with interested parties on the issue in a transparent 
manner.  
3.3.4   Uruguay – Labelling of Packaged Food  (IMS ID 5787) 
3.21.   The representative of Costa Rica  raised concerns with Uruguay's regulation on the labelling of 
packaged food. The full statement is contained  in G/TBT/W/613 . 
3.22.   The representative of the United States  thanked Uruguay f or their bilateral meeting and noted 
their support of Uruguay 's objectives of reducing diet related non -communicable diseases. She 
stated that the final decree as notified may, however, not be based on robust scientific evidence, be 
more trade restrictive than necessary to achieve a legitimate objective, did not appear to consider 
the relevant international standards, and may contribute to consumer confusion.  She further asked 
whether positive health claims would be allowed for foods such as yogurts, cereal s, or oatmeal which 
were required to carry the warning label but may also contain other nutrients, be fortified, or make 
other positive contributions to an overall diet.  In addition, she noted that the United States had not 
receive d a response to its 2017 comments on the draft decree and asked whether Uruguay had 
reviewed evidence -based international standards to determine if they would fulfil Uruguay 's public 
health objectives. Although the US had listed international standards in communication with 
Urugua y, the original draft document  did not mention Codex standards being utilized or evaluated, 
while the final decree only mention ed the Pan American Health Organization 's Nutrient Profile Model. 
The United States further asked whether Uruguay had considered that the required black and white 
octagonal "stop sign " symbols  and the new requirement that they contain the initials MPH in addition 
to the statement that the product was in "excess of " a spe cified nutrient may cause consumers to 
avoid products that could be part of a healthy diet . She asked whether studies in Uruguay had 
demonstrated that this interpretive approach was more effective than present ing nutrient and calorie 
information on labels based on serving size portions of the product , and whether Uruguay had 
evaluate d any alternative labelling schemes, or a voluntary approach.  
3.23.   The representative of the European Union  noted interest in this regulation and asked  for a 
written reply to the com ments the delegation would send.  
3.24.   The representative of Guatemala  reiterated concerns over the creation of divergen t labelling 
of packaged food without taking into account the Codex Alimentarius. She noted that this worked in 
favour of large firms with the capacity to create labels for different markets and consequently 
discriminated against MSMSEs and SMEs. While recognizing Members ' legitimate objectives in this 
domain, she highlighted that technical regulations should not be any more restrictive than nece ssary.  
3.25.   The representative of Uruguay  responded to the concerns raised. The statement is contained 
in G/TBT/W/614 . 
                                                
6 For previous statements follow the thread under IMS ID 577  (under dates raised and references) . 
7 For previous statements follow the thread under IMS ID 578  (under dates raised and references) . G/TBT/M/77  
 
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  3.3.5   European Union - Chlorothalonil (pesticide active substance) G/TBT/N/EU/625  
(IMS ID 5798) 
3.26.   The representative s of the United States  and Colombia  raised concerns with the EU's measure  
on chlorothalonil . The full statement s are contained in G/TBT/W/607  and G/TBT/W/600 , 
respectively.  
3.27.   The representative of Guatemala  expressed  concern with respect to the measure  notified in 
G/TBT/N/EU/625  of 4 December  2018, with respect to the non -renewal of the approval of the active 
substance chlorothalonil , a substance generally used by some agricultural producers as a fungicide 
to control  certain pests.  Her delegation  reiterated its belief that the EU should take a risk -assessment 
approach base d on sufficient scientific evidence in determining control levels, particularly those 
established in the Codex Alimentarius.  Guatemala considered that changes to agricultural practice 
require d a more extensive process  and that it was important to be adapta ble in seeking alternatives 
as regards the use of pesticides. She pointed out that as t hese processes were lengthy, transitional 
periods should  be set accordingly.  
3.28.   Guatemala associate d itself with Colombia's request to maintain the approval of chlorothalonil  
in the EU, and with the concerns previously expressed by other Members. She also called upon the 
EU to offer solutions and alternatives for tropical countries in respect of  their ability to adapt in this 
area. Referring to the indication in the EU's notification that the maximum residue levels (MRLs) for 
pesticides containing chlorothalonil may be revised in the future , clarification and information about 
the work plan envisaged was requested, as well as the arguments being put forward  in tha t regard.  
3.29.   The representative of Brazil  shared Colombia's concerns, in particular the fact that the EU's 
decision was founded only on a hazard -based approach, without a proper risk analysis. The non -
renewal of approval for chlorothalonil by the EU did not t ake into consideration that it was currently 
authorized in 109 countries, and that the MRLs allowed by Codex could reach up to 70 mg/kg, 
depending on the product. In this context, he reiterated Brazil's concerns with the fact that some 
analyses conducted b y the European Food Safety Agency (EFSA), whose results on the genotoxicity 
of substances were founded on a hazard -based approach, had led to the non -renewal of certificates 
and subsequently to the reduction of MRLs. The case of chlorothalonil, he said, ha d a negative impact 
on Brazil's trade of agricultural products, such as banana, coffee, citrus fruits, papaya, watermelon, 
among others, which used this substance for pest control. He recalled that for all those commodities, 
Brazil adopted MRLs below those  established by Codex, in line with concerns related to consumer 
safety.  
3.30.   Finally, Brazil reiterated its systemic concern with the fact that issues relating to the non -
renewal of agricultural pesticides were being dealt firstly in the TBT Committee. He said  that in many 
cases the communication of non -renewal of approval of important substances for trade of agricultural 
commodities was notified in the TBT Committee as an announcement of the future reduction of MRLs 
in the SPS Committee. In this context, Brazi l asked the EU about the eventual next steps regarding 
the possible reduction of MRLs for chlorothalonil and that this be notified to the SPS Committee as 
soon as possible.  
3.31.    The representative of Panama  reiterated his delegation's continuing concern, alrea dy 
expressed in the TBT Committee as well as the SPS Committee, on measures being taken by the EU 
which appeared to go beyond Codex Alimentarius scientific evidence.  
3.32.   The representative of Paraguay  expressed concern with the measure as in Paraguay, 
chloroth alonil was classed as a low -risk pesticide and sold freely. It was used for several key products 
exported from Paraguay, such as corn, wheat, rice and soya and whilst not the main input of 
phytosanitary products for the pest control of such crops, it was c onsidered as a component in the 
rotation of these products to address handling shortfalls and prevent resistance to other active 
substances. Her delegation deemed that the categorization of chlorothalonil as carcinogenic, carried 
out by the EFSA, was based  on inconclusive claims. The proposal to eliminate the use of this active 
substance had once again been based on a hazard assessment rather than a consumer risk 
assessment, and, once again, did not comply with relevant international standards. It was felt that 
                                                
8 For previous statements follow the thread under IMS ID 579  (under dates raised and references) . G/TBT/M/77  
 
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  rather than providing a genuine solution or fulfilling the objective of health protection, this situation 
would  result in unnecessary barriers to trade.  
3.33.   Paraguay also expressed concern with the  pattern of action taken by the EU, start ing with the 
prohibition of the marketing of a substance and then mov ing to the amendment of the MRLs for that 
substance. Her delegation believed that s uch amendments establish ed levels that were equivalent 
to a prohibition  of the use of the substance and did not ensure import tolerances.  The EU was urged 
to comply with the international commitments that it ha d undertaken in the WTO , and to carry out 
risk assessments rather than hazard assessments when making this type of decision.  
3.34.   The representative of Canada  thanked Colombia for bringing the issue to the attention of the 
Committee as chlorothalonil  was registered for use in field and orchard crops in Canada. She said 
that a growing number of active substances were not being renewed in the EU due to incomplete  or 
insufficient information to complete a risk assessment and excluded health and environmental 
concerns. Canada considered this a worrisome trend that may affect agriculture and food imports in 
the EU given the lack of clarity on how import tolerances wo uld be established following a non -
renewal decision due to lack of such information. Her delegation encouraged the EU to indicate what 
information was needed to complete and conclude its risk assessment.  
3.35.   The representative of Ecuador  was aware that th e decision currently only mention ed the 
placing of th e substance on the market and not of an MRL for this product. Her delegation 
nevertheless express ed concern over the fact that specific measures could be taken regarding the 
MRLs and that such measures could be very restrictive. In Ecuador , she said, active chlorothalonil 
registers were kept for several agricultural products, but the substance was especially used as a 
technological tool to help control Black Sigatoka in bananas. The EU was request ed to take into 
consideration the fact that Ecuador's banana exports account ed for 2% of overall GDP and 
approximately 35% of agricultural GDP. According to registers of the  Ministry of Agriculture and 
Livestock (MAG), about 162,236 hectares had been cultivat ed with bananas , representing  
4,473  banana producers (small (3,480), medium -size (800) and large (193) ). Ecuador therefore 
urged that, before a final decision was taken on implementing the measure and another on possible 
assessment of the MRLs, the Europea n Commission consider all existing data, as well as comments 
submitted to it, with due regard for the implications on the food -producing sector of developing 
countries.  
3.36.   The representative  of Costa Rica  raised concerns with the EU's measure  on chlorothaloni l. The 
full statement is contained in G/TBT/W/612 . 
3.37.    The representative of Honduras  expresses its trade  interest in the issue and asked the EU for 
more information on the criteria used for the implementation of the measure.  
3.38.   The representative of the European Union  responded to the concerns raised. The full 
statement is contained in G/TBT/W/625 . 
3.3.6   European Union - Transitional periods for MRLs and interna tional consultations 
(IMS ID 5809) 
3.39.   The representative of Colombia  raised concerns with the EU's transitional periods for MRLs 
and international consultations . The full statement is contained in G/TBT/W/601 . 
3.40.   The representative of Guatemala  reiterate d the importance of us ing a risk -assessment 
approach as a frame of reference, to avoid the creation of measures generat ing unnecessary 
barriers, and the need for such measures to be based on scientific evidence . She recalled that her 
delegation had said repeatedly that products  from tropical countries, where climatic conditions were 
different, and farmers must contend with challenges not faced by European producers, were placed 
at a disadvantage by measures of this kind.  This was consistent  with the provisions of the TBT 
Agreeme nt that such measures should not be more trade -restrictive than necessary.  She said that 
producers and exporters were trying to comply with the established conditions to continue 
responding to market demand and fulfilling contractual obligations . Periods a llowed , however,  were 
short, making it harder to find alternatives . Guatemala support ed the requests made to create a 
                                                
9 For previous statements follow the thread under IMS ID 580  (unde r dates raised and references) . G/TBT/M/77  
 
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  space in the WTO for technical discussion and evaluation of the transition periods allowed for the 
implementation of changes to regulations  and propose d an extension of at least six additional 
months for the entry into force of the provisions concerning buprofezin.  
3.41.   The representative of the United States  associate d itself with  and expressed support for the 
concerns of Colombia abou t the EU system .  
3.42.   The representative of Paraguay  was concerned that the  length of the transition period granted 
for the implementation of amended MRLs was not sufficient for the competent domestic institutions 
to revise and potentially amend national regul ations, and for producers to adapt to the new 
requirements established by the importing party. It is also worrying that the concerns raised, and 
comments made during  international consultations had not been  taken into account by the European 
authorities wh en adopting these amendments.  
3.43.   The representative of Brazil  expressed support for the concerns raised by Colombia. His 
delegation emphasised the importance of Article 2.12 of the TBT Agreement, as relates to the 
provision of a reasonable interval between th e publication of technical regulations and their entry 
into force, except in cases of urgent problems of safety, health, environmental protection or national 
security. Also highlighted was the WTO Ministerial Decision of November 2001, on "Implementation -
Related Issues and Concerns ", which said that a "reasonable interval" should be understood to 
normally mean a period of not less than six months, except when this would be ineffective in fulfilling 
the legitimate objectives pursued. His delegation believe d that it was important to guarantee 
adequate intervals of transition, especially for those cases in which the scientific opinions of the 
European Food Safety Authority on the toxicity of substances were "inconclusive" or only indicated 
a "suspected risk". H e reiterated Brazil's concern that in some of these cases, also founded on a 
hazard -based approach, the EU was deciding to reduce the MRLs of certain substances.  
3.44.   The representative of Ecuador  shared Colombia's concern that these periods were too short 
and did not give time to find alternatives which could lead to a blockage of exports to this important 
market. She added that it would have a deep impact on producers, many of whom were low -income 
SMEs, without access to other sources of income.  
3.45.   The representa tive of Costa Rica  joined Colombia in request ing an exten sion of  the time -limit 
for compliance with the new tolerance established for buprofezin, due to its major impact on exports 
of Costa Rican bananas to the European market.  His delegation  was greatly concerned by the 
European Union's revision of the tolerances for different substances used in agricultural production. 
He echoed Colombia in explaining that  it was impossible for agricultural production to adjust to new 
requirements and tolerances within six  months, when the registration alone of new molecules must 
undergo a full evaluation lasting much longer than this time -limit. Costa Rica urged the EU to 
establish a dialogue with the countries exporting agricultural products that were seriously affected 
by the amendments made unilaterally to MRLs by a trading partner. It was hoped that these studies, 
analyses and decisions be adopted multilaterally in the framework of the Codex Alimentarius, in  line 
with the spirit of WTO rules . 
3.46.    The representati ve of Panama  joined other Members in calling for dialogue on the new MRL 
levels that had been assessed for different chlorates and other substances, as well as an extension 
of the deadline to allow less trade -restrictive alternatives to be found.  
3.47.   The repre sentative of the European Union  stated that as a matter of principle, the EU 
considered concerns on the setting of MRLs for pesticides – and any details regarding their 
implementation – to be a matter for discussion at the SPS Committee, rather than at the  TBT 
Committee. He said that the EU fulfilled all its obligations under both the TBT and the SPS 
Agreements, including notifying its trading partners of planned measures falling within the scope of 
either of the agreements. Information and comments receive d in response to these notifications 
were duly considered and taken into account before a final decision was taken. This was clearly and 
extensively explained in each EU reply to those trading partners that submitted comments.  
3.48.   As regards possible transitio nal periods when MRLs were lowered, the EU informed the 
Committee about two key provisions of such measures. First, following the formal adoption, 
publication and entry into force of an act lowering MRLs, a deferred date of application was set. The 
date of  application was the date from which the new/lower MRLs were effectively enforced. The G/TBT/M/77  
 
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  length of the deferral was six months after entry into force, in the vast majority of cases. This 
deferral of the application date permits, inter alia , third countries a nd food business operators to 
prepare to meet the new requirements resulting from the modification of the MRLs. Second, products 
produced in the EU or imported into the EU before the aforementioned application date may continue 
to benefit from the old/high er MRLs and remain on the market, if information showed that a high 
level of consumer protection was maintained. This was regularly not the case where MRLs were 
lowered because the safety of consumers could not be demonstrated.  
3.3.7   Jamaica - Regulations Bannin g Single -Use Plastic Products  (IMS ID 58110) 
3.49.   The representative of the Dominican Republic  raised concerns with the Jamaica's measure on 
the prohibition of plastic packaging materials . The full statement is contained in G/TBT/W/611 . 
3.50.    The representative of Jamaica  advised the Committee that the observations raised by the 
Dominican Republic had been duly noted in capital and that her delegation would revert on the issue.  
3.3.8   Republic of Korea - Regulation on Energy Efficiency Management Equipment  
G/TBT/N/KOR/772  (IMS ID 58211) 
3.51.   The representative of China  raised concern that Korea had notif ied this regulation to the WTO 
on 28 May 2018, with a proposed enforcement date of 1 July 2018, only providing Members with a 
one-month transitional period. Not only was this period less than the six months recommended by 
the TBT Committee, but also less t han the transitional period provided for domestic enterprises. 
According to relevant provisions of TBT Agreement, China suggested that Korea provide national 
treatment for other Members and extend the transition period to six months. The regulation 
establi shed different cleaning ratio requirements for pulsator washing machines and roller washing 
machines under the cold -water washing mode; in light of this, his delegation also suggested that 
Korea establish es technical requirements based on product performan ce and use s the same 
requirement for both kinds of washing machine.  
3.52.    The representative of the Republic of Korea  committed to respond to China's concerns after 
consulting with relevant authorities, and to keep consulting with interested parties on the iss ue in a 
transparent manner.  
3.3.9   Kingdom of Saudi Arabia – Technical Regulation for plastic products OXO – 
biodegradable  (IMS ID 58312) 
3.53.   The representative of the European Union  raised concerns with the Kingdom of Saudi Arabia's 
technical regulation for oxo -degradable plastic products. The full statement is contained in 
G/TBT/W/626 . 
3.54.   The representative of the United States  expressed support for t he EU in raising this concern.  
3.55.    The representative of the Kingdom of Saudi Arabia  announced that it would delay the 
implementation of stage 2 and 3 of this technical regulation until September 2019. In the meantime, 
he reported, a national study had been l aunched to investigate the claim of the adverse impact of 
the oxo -degradable on the environment, taking into account climatic conditions in Saudi Arabia. His 
delegation requested the EU for any recent research on the matter and flagged that a bilateral 
meeting would be held with the EU to discuss the issue.  
                                                
10 For previous statements follow the thread under IMS ID 581  (under dates raised and references) . 
11 For previous statements follow the thread under IMS ID 582  (under dates raised and references) . 
12 For previous statements follow the thread under IMS ID 583  (under dates raised and references) . 
 G/TBT/M/77  
 
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  3.4  Previously raised concerns  
3.4.1   Indonesia — Technical Guidelines for the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety, G/TBT/N/IDN/64 , 
G/TBT/N/IDN/64 /Add.3 (IMS ID 32813) 
3.56.   The representative of the European Union  raised concerns with Indonesia's  recent amendment 
to Regulation of Minis ter of Industry No. 24/2013 on the mandatory implementation of the Indonesia 
national standard (SNI) for Toys introduced by Regulation of the Minister of Industry on 29 
November 2018 and notified on 30  November  2018 ( G/TBT/N/IDN/64/Add.3 ). The full statement is 
contained in G/TBT/W/627 . 
3.57.    The representative of the United States  noted that dialogue on  Indonesia's toy standard 
dated back to 2012.  It was her delegation's understanding that Indonesia's Ministry of Industry 
(MOI) had been working with stakeholders to address outstanding issues and it was hoped that this 
would lead to resolution of long -standing concerns. It was also the understanding of the US that 
Indonesia had revised MOI Regulation 24/2013 "on the Mandatory Implementation of Indonesian 
National Standard (SNI) for Toys", through issuance of MOI Regulation 29/2018, and had notified it 
to the WTO. It was noted, however, that the notification had come after the regulation had been 
issued and in force and therefore requested an update on the timeline for issuance of implementing 
measures to the regulation.  
3.58.   The US reiterated previously raised concerns about conformity assessment, noting that the 
requirement for a Mutual Recognition Agreement (MRA) with Komite Akreditasi Nasional (KAN) in 
order to recognize labs for the testing of toys outside Indonesia remained in Regulation 29/2018. 
Her delega tion urged Indonesia to accept any ILAC -accredited laboratory on a permanent basis, 
without requiring a government -to-government MRA. Indonesia was requested to draft 
implementing measures to address Members' concerns, including easing strict conformity 
assessment procedures for imported products, eliminating domestic testing requirements not 
acknowledging ILAC -accredited laboratories, and changing the incorporation by reference from the 
old SNI 7617:2010, rather than the new SNI 7617:2013, which, in the vi ew of the US, was in greater 
alignment with international standards for formaldehyde testing.    
3.59.    The representative of Japan  expressed support for the EU's position and welcomed the fact 
that Indonesia had revised its toy regulation, responding to the requ ests from the EU, Japan and 
other Members. She expressed particular appreciation for the introduction of a new scheme 
incorporating a quality management system in the production process as an option for toy 
certification procedures. In order to avoid unnec essary technical barriers to the toy trade in 
Indonesia, Japan considered the implementation of rules, such as procedures for factory audit, 
essential to making this new toy certification scheme useful. In this regard, Japan encouraged 
Indonesia to make co ntinued efforts to develop implementation guidelines consistent with WTO 
rules. Her delegation remained concerned that the revised regulation still contained unnecessary 
trade -restrictive measures such as the testing requirement for "each -and-every import shipment", 
the existing certification scheme, and the overseas laboratory accreditation requirement. Indonesia 
was asked to revise these discriminatory requirements to be consistent with its WTO TBT obligations.  
3.60.    The representative of Canada  supported the interventions made by other delegations and 
requested the use of non -discriminatory requirements that were the least trade restrictive as 
possible and to permit the use of foreign accreditation bodies. Canadian stakeholders had expressed 
concerns regarding  the revised safety requirements of the measure, namely that domestic products 
continued to enjoy a more favourable testing frequency, that certification was permitted in only a 
limited number of Indonesian labs and that the requirements were overly burden some. At the 
November 2018 Committee meeting Indonesia had noted that a review of the requirements was 
nearing completion and that the new sampling method would be more flexible. Indonesia was asked 
to update the Committee on how the review had met this go al. 
                                                
13 For previous statements follow the thread under IMS ID 328  (under dates raised and references) . G/TBT/M/77  
 
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  3.61.   The representative of Indonesia  informed Members that the revision process had finally 
concluded by the issuance of Regulation of Minister of Industry Number 29/2018 and that the 
drafting of implementing guidelines thereto was currently in process.  
3.4.2   European Union — Draft Implementing Regulatio ns amending Regulation 
(EC) No. 607/2009 laying down detailed rules for the applicatio n of Council Regulation 
(EC) No  479/2008 as regards protected designations of origin and geographical 
indications, traditional t erms, labelling and presentation of certain wine sector products , 
G/TBT/N/EEC/264 , G/TBT/N/EEC/264/Add.1 , G/TBT/N/EU/571  (IMS ID 34514) 
3.62.   The representative of Argentina  raised concerns with the EU's regulati ons on protected 
designations of origin and geographical indications, traditional terms, labelling and presentation of 
certain wine sector products. The full statement is contained in G/TBT/W/605 . 
3.63.   The representative of the United States  reiterated previously raised concerns regarding the 
EU's delay in resolving this specific tra de concern.15 
3.64.   The representative of Brazil  supported the concerns raised by Argentina and the US . As stated 
in previous meetings, the terms contained in the regulation also affect ed Brazilian wine producers , 
and the fact  that the EU was still analysing this case after over a decade show ed that this measure 
was a non -tariff barrier and does not  pursue any legitimate objective under the TBT Agreement . 
Brazil ask ed if the EU could share any updated information and the estimated time -frame r elated to 
the use of regulated terms for wines exported to the EU in Regulation (EC) No. 607/2009, Council 
Regulation (EC) No 479/2008 and revised regulations notified under G/TBT/N/EU/570  and 
G/TBT/N/EU/571 . 
3.65.   The representative of the European Union  recalled that the EU had undert aken a revision of 
its legislation on wine, including on traditional terms (see G/TBT/N/EU/571 ), as explained in previous 
TBT Committee meetings . This process resulted in the adoption of C ommission Implementing 
Regulation (EU) 2019/34 of 17 October 2018 laying down rules for the application of Regulation (EU) 
No 1308/2013 of the European Parliament and of the Council (as regards applications for protection 
of designations of origin, geograp hical indications and traditional terms in the wine sector, the 
objection procedure, amendments to product specifications, the register of protected names, 
cancellation of protection and use of symbols ), and  of Regulation (EU) No 1306/2013 of the European 
Parliament and of the Council (as regards  an appropriate system of checks ). She said t he European 
Commission will now undertake the examination of pending applications for traditional terms , and 
that no precise timeline can be provided at this stage . 
3.4.3   Europ ean Union — Quality Schemes for Agricultural Products and Foodstuffs, 
G/TBT/N/EU/139 , G/TBT/N/EU/139/Add.1  and G/TBT/N/EU/593  (IMS ID 51216) 
3.66.   The representatives of Argentina  and the United States  raised conc erns with the European 
Union's Quality Schemes for Agricultural Products and Foodstuffs. The full statements are contained 
in G/TBT/W/604  and G/TBT/ W/608 , respectively.  
3.67.   The representative of Uruguay  referred to previous statements made in both the TBT 
Committee17 and in the Council for Trade in Goods. He said that his delegation continued to have 
concerns regarding the protection and registration of th e term "danbo" as a protected geographical 
indication by the European Union. "Danbo", it was stressed, was a generic term and was therefore 
not eligible for registration as a geographical indication and could not have any limitations placed on 
its use. Ind eed, a reading of point 7 of the standard CODEX STAN 264, adopted in 1966 and updated 
several times with the participation of the European Union and its member States, showed that 
Members recognized "danbo" as a generic term used for referring to a good th at could be produced 
in various locations as long as it satisfied the requirements set forth in the standard. The 
representative of Uruguay regretted the position taken by the European Union that the matter 
concerned intellectual property and therefore cou ld not be addressed in the TBT Committee. He 
reminded the EU delegation that the regulation granting these rights had been correctly notified by 
                                                
14 For previous statements fo llow the thread under IMS ID 345  (under dates raised and references) . 
15 G/TBT/M/76 , para. 3.55.  
16 For previous statements follow the thread under IMS ID 51 2 (under dates raised and references) . 
17 G/TBT/M/76 , para. 3.127; and G/TBT/M/75 , para . 4.140 and G/TBT/W/543 . G/TBT/M/77  
 
- 13 - 
 
  the European Union itself to the TBT Committee on 18 November 2013 in document G/TBT/N/EU/139  
precisely because it had TBT -related implications for matters such as labelling and rele vant 
international standards. Therefore, Uruguay urged the European Union to reconsider its measure to 
avoid unnecessary restrictions to trade, while duly taking into account the international standards 
established by the Codex.  
3.68.   The representative of New Zealand  remained concerned that the European Commission had 
chosen to register the term Danbo, despite having previously agreed to a Codex standard in which 
the European Commission and Denmark both acknowledged "the country of origin statement 
preserves it s generic nature ". Such actions would negatively affect producers outside Denmark who 
had invested with the legitimate expectations that they could use the standard. These actions 
showed disregard for the integrity of the international standards setting sy stem that promoted 
reliability and consistency in international trade rules - which New Zealand expected the EU to 
support.  
The representative of the European Union  repeated the response provided in previous TBT 
Committee meetings.18 
3.4.4   The Separate Customs Te rritory of Taiwan, Penghu, Kinmen and Matsu – Draft of 
the Organic Agriculture Act, G/TBT/N/TPKM/225 , G/TBT/N/TPKM/225/Add.1 -2; 
G/TBT/N/TPKM/346 , G/TBT/N/TPKM/347  and G/TBT/N/TPKM/348  (IMS  ID 51119) 
3.70.   The representative of the European Union  reiterated previously raise d concerns.20  
3.71.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
stated that his delegation had notified three draft implementation regulations to the WTO on 7 
January 2019 ( G/TBT/N/TPKM/346 , 347 and 348) that explained the administrative processes for 
the management of imported organic agricultural products. Chinese Taipei welcomed c omments 
from the EU and would maintain close contact to address those concerns. Furthermore, a bilateral 
working level video confe rence had been  held on 14 December 2018 including  discussions on the 
procedures for accrediting certification bodies in the EU. Certification bodies in the EU were welcome 
to apply for recognition upon the adoption of the notified regulations. Chinese Taipei had high 
expectations to reach consensus on bilateral organic equivalence with the EU as it was the most 
convenient way to export organic products to Chinese Taipei. He concluded that Chinese Taipei 
already extended the transition period for  Members and urged the EU to start negotiating the 
bilateral organic equivalence agreement.  
3.4.5   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 50921) 
3.72.   The representative of the European Union  again referred to concerns raised in previous 
meetings. In light of the on -going reform of the standardization system in China, she asked when 
the new consolidated standards would be finalized, notified to the WTO, and when they would enter 
into force. To help facilitate implementation, the EU needed to know whether the announced 
consolidation of the standards would replace the previous ones contained in G/TBT/N/CHN/1094 -
1095-1096, and whether the outcome would be a development of one new s tandard replacing the 
previous ones. The EU also needed to receive information concerning the scope of consolidation and 
whether it would concern the same furniture product groups as the previous standards or would it 
be either broader or cover fewer furni ture product groups. The EU also asked what limits of harmful 
substances would be covered by the consolidation. She asked if China considered it timely and 
relevant to consider exploring the possible use of ISO standards, either those existing or those sti ll 
in development. She asked for clarification on which body would be responsible for the development 
of the new standard and if it was to be the body dealing with environmental standards. The EU 
remained open to hold technical discussions in Brussels on issues relating to furniture standards, as 
                                                
18 G/TBT/M/76 , para. 3.128; and G/TBT/M/75 , para . 4.142 and G/TBT/W/501 . 
19 For previous statements follow the thread under IMS ID 511  (under dates raised and references) . 
20 G/TBT/M/76 , para. 3.129; G/TBT/M/75 , para. 4.145 –4.146; G/TBT/M/74 , para. 2.169 and 
G/TBT/W/502 . 
21 For previous statements follow the thread under IMS ID 509  (under dates raised and references) . G/TBT/M/77  
 
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  originally proposed by China in June 2017 , and requested that China designate its contact point for 
the organi zation of such a meeting.  
3.73.   The representative of China  informed the Committee that in 2016 under the six measures of 
"Deepening the Reform Programme of Standardization work", China had simplified and integrated 
all the mandatory standards, including those in the furniture industry. On 14 January 2017, the 
China National Standardization Administration Committe e published the "Notification of the issuance 
of conclusion of the simplifying and integrating of Chinese mandatory standards" (No.4 document of 
SAC in 2017). In this conclusion, the above three standards needed to be integrated before they 
could be releas ed. As a result, these three standards had not yet been published and implemented. 
The relevant requirements of "Notification of completing the follow -up work for the conclusion of the 
simplifying and integrating of mandatory standards" (No. 464 document o f the Department of 
Science and Technology, Ministry of Industry and Information Technology in 2017), the standards 
development work was ongoing, and the mandatory standards project proposal "Limit of hazardous 
substances in furniture" had been raised and published online in accordance with the relevant 
procedures. It was now in the process of soliciting public opinion.  
3.4.6   European Union — Titanium dioxide: Regulation (EC) No 1272/2008 (CLP 
Regulation), Annex VI, G/TBT/N/EU/629  Part 2 (IMS ID 53922) 
3.74.   The representative s of the United States  and Mexico  raised concerns with the European 
Union's Titanium dioxide regulation.  The full statement s are contained in G/TBT/W/609  and 
G/TBT/W/619 , respectivel y. 
3.75.   The representative of Japan  raised concerns with the provisions for titanium dioxide and 
mixtures containing titanium dioxide contained in the EU's 14th adaptation to technical progress 
(ATP) proposal to CLP regulation. Japan asked the EU to ensure that  the regulation would not be 
more trade -restrictive than necessary.  
3.76.   The representative of Canada  noted the concerns raised by other delegations about the EU's 
proposed changes to the regulations and voiced particular concern about the potential impact on 
trade in products containing titanium dioxide or cobalt and the process that the EU had followed to 
arrive at the proposed amendments to the CLP Regulations. His delegation considered that changing 
the classification of titanium dioxide and cobalt under the  CLP Regulations could result in stricter 
requirements under other regulations, beyond simple labelling requirements, which could in turn 
have a significant impact on trade from Canada. Cobalt, for instance, was present in small amounts 
in nickel. Canada e xported $1.1 billion in various types of nickel to the EU in 2017, representing 
29% of Canada's total nickel exports. As a result, any fluctuations in the EU's demand for nickel or 
downstream products, such as stainless steel, would have very significant i mplications for Canada's 
nickel industry.  
3.77.   The EU was asked to explain the next steps in its process to consider the proposed changes, 
including any relevant timelines. In addition, an explanation of how products contain ing titanium 
dioxide or cobalt would  be treated under the entire EU regulatory framework as a result of the 
proposal was requested. Furthermore, Canada suggested that the EU conduct a Better Regulation 
Impact Assessment in order to ascertain the full range of economic and health and safety i mpacts 
that may result from the proposal.  
3.78.    The representative of Australia  recognized the EU's right to regulate for public and 
occupational health and safety, also recognizing that appropriate classification and labelling for 
hazardous substances and mixt ures could address legitimate public and occupational health 
concerns. His delegation raised the possible implications of classification of Titanium Dioxide (TiO2) 
as a carcinogen as, according to Australia, it may create unnecessary obstacles to internati onal trade 
for TiO2 and products containing TiO2. In this context, Australia suggested that alternative 
regulatory measures were available to address the EU's concerns that would more directly address 
the potential health hazards of TiO2 without affecting trade.  
3.79.   The Australian industrial chemicals regulator, the National Industrial Chemicals Notification 
and Assessment Scheme (NICNAS) had undertaken recent assessments on the risks of TiO2 
                                                
22 For previous statements follow the thread under IMS ID 539  (under dates raised and references) . G/TBT/M/77  
 
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  (excluding nano particles of TiO2), and found that: (i) exposure to T iO2 in a finished product through 
dermal, inhalation and oral routes presents limited risks to human health; and that (ii) appropriate 
work health and safety controls were adequate to protect public and workers' health and safety in 
relation to TiO2 inhala tion exposure. The NICNAS information sheet on nanoparticles of TiO2 stated 
that there was some evidence that breathing in large quantities of TiO2 nanoparticles over a long 
period of time may cause toxic effects due to impairment of normal lung clearance mechanisms but 
the studies available (up to 2012) did not provide sufficient evidence to conclude that TiO2 caused 
lung tumours in humans.  
3.80.   Australia suggested that if a classification was proposed for TiO2, it should be limited to 
nanoparticles of TiO2 (<1 00 nm in size) and only through the inhalation route. He added that there 
should be clear evidence that the carcinogenicity was from TiO2 and not from the insoluble nature 
of TiO2 nanoparticles causing lung overloading. TiO2 was a premium pigment used in t he 
manufacture of a wide range of products, most commonly paint and coatings and it was stressed 
that as per TBT Agreement commitments the EU must ensure that any regulation to address 
concerns about the possible carcinogenicity of TiO2 when inhaled was no  more trade restrictive than 
necessary and did not unduly impact trade in goods containing TiO2.  
3.81.   The representative of the European Union  responded to the concerns raised. The full 
statement is contained in G/TBT/W/628 . 
3.4.7   Israel — Addendum to the Pharmacist Regulations (Cosmetics 5778 -2018) 
G/TBT/N/ISR/709/Add.2  (IMS ID 55223) 
3.82.   The representative of the European Union  raised concerns with Israel 's Addendum to the 
Pharmacist Regulations (Cosmetics 5778 -2018). The full statement is contained in G/TBT/W/629 . 
3.83.    The representative of the Republic of Korea  expressed its continued interest in the Addendum 
to the Pharmacists Regulations notified by Israel on 23 January 2018, and voiced concern that the 
requirement for GMP certi fication from a health authority for cosmetics was not in line with 
international standards and would cause unnecessary obstacles to international trade. Also, it was 
considered that requiring the submission of quarterly reports for every single product wo uld impose 
substantial administrative burdens on industries. He enquired when the draft would be finalized and 
urged Israel to notify the revised regulations reflecting Members' comments to the TBT Committee.  
3.84.    The representative of Israel  stated that the process to align its cosmetics regulations with 
international best practice had started in 2013. The most recent notification on this measure had 
been made on 23 January 2018 when Israel notified its amended regulations to the TBT Committe e 
in G/TBT/N/ISR/709/Add.2  to which the EU had provided comments  on 14 February 2018. Israel 
had responded in writing to these comments on 26 February 2019 whilst at the same time providing 
Korea with a written response to their concerns raised in the Committee. He said that with regards 
to the notion of Responsible Pe rson, the origin of the requirement that a responsible representative 
must not be a corporation, was embodied in Article 55.A.6 of the Pharmacists' Order (New Version), 
5741-1981 (hereafter – "The Order") and not in the Pharmacists' Regulations (Cosmetics) , 5779 -
2018 (hereafter "The Regulations "). Similarly, the source of the requirement for a report by the 
responsible representative lay in the main legislation. In view of the normative standing of The 
Regulations it was not possible to incorporate an artic le that contradicted an element of the main 
legislation, however the Ministry of Health was examining the possibility of revising The Order.  
3.85.   With regards to the concerns over the Product Notifications, the Good Manufacturing Practice 
Certificate, Parallel  Imports and Nano Notifications, Israel was currently re -examining the text of the 
Regulations and the need to revise them. During this process all the comments submitted would be 
examined, including those of the EU and Korea, and the remarks would be born e in mind as the 
Regulations were processed by Israel's parliament (the Knesset). Regarding the Product Information 
File (PIF), the provisions of Article 23 in the Draft Regulations allowed for the digital storage of the 
Cosmetics File. The Draft Regulatio ns did not require that the Cosmetics File be held physically in 
the company offices. Similarly, with respect to the EU's comments regarding the maintenance of 
documentation and its presentation for examination by the Ministry of Health, as part of the 
development of the Regulations, Israel would examine the comments and take them into account. 
                                                
23 For previous statements follow the thread under IMS ID 552  (under dates raised and references).  G/TBT/M/77  
 
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  Finally, with respect to the Implementation Period, Regulation 70 of the Draft Regulations 
determined an initial requirement which would become effective within a ye ar of their publication.  
3.4.8   Brazil — Draft Technical Resolution n° 51, 7 April 2017 on labelling of beverages, 
wine, and grape derivatives, G/TBT/N/BRA/719  and G/TBT/N/BRA/719/Add.1  (IMS ID 55724) 
3.86.   The representative of the European Union  referred to the written comments of 16 August 
2017 and the previous statements made at previous TBT Committee meetings. The EU stressed the 
importance for p roducers of clear and proportional requirements on labelling and asked that Brazil 
clarify how this draft related to other regulations, including general rules on consumer protection 
and specific regulations on wine, as they appeared to overlap. The EU enc ouraged Brazil to apply to 
the greatest possible extend international standards adopted by the OIV. Given the time that had 
elapsed since the notification and submission of comments, the EU asked what was the state of play 
of the adoption procedure. She in vited Brazil to take the EU concerns into account when preparing 
the final resolution and to reply to the EU written comments.  
3.87.   The representative of Brazil  informed the Committee that the process of draft TR No. 51 was 
still in progress and Brazil was the refore not in a position to provide replies to the comments 
submitted by the EU. The comments were still being analysed by the Ministry of Agriculture. He 
informed the Committee that new consultations and a public hearing were being organized in 2019, 
where interested parties would again be able to express their views on the draft regulation.  
3.4.9   European Union — Regulation of the European Parliament and of the Council laying 
down rules and procedures for compliance with and enforcement of Union harmonization 
legislation on products and amending relevant regulations  G/TBT/N/EU/542  (IMS ID 
56525) 
3.88.   The representative of China  raised concerns about the EU's Regulation of the European 
Parliament and of the Council laying down rules and procedures for compliance with and enforcement 
of Union harmonization legislation on products and amending relevant regulations. The full 
statement is contained in G/TBT/W/617 . 
3.89.   The representative of the United States  noted that it also ha d concerns and had requested 
the EU to re -notify.  
3.90.   The representative of the European Union  said that safety and compliance of products was an 
import ant matter for consumers. Public authorities in EU member States had to be able to check 
that products on their home market were safe for their citizens. The market surveillance authorities 
in the EU faced difficulties in checking compliance of goods origi nating outside the EU. Therefore, 
the EU proposal for a Regulation contained a requirement that there should be a person in the EU 
responsible for compliance information on products. It was also recalled that this was not a new 
approach. A significant numb er of EU laws on products had similar provisions but they did not achieve 
the desired effect due to new types of e -commerce supply chains. Negotiations between the 
European Parliament and the Council had resulted in a political agreement on the Regulation in 
February. This agreement still needed to be formalised, but the details were already available.  
3.91.   Regarding the provision for an interlocutor in the EU, the main change was with respect to 
product scope. It would only apply to 18 EU laws on products, ins tead of 66 as foreseen in the initial 
proposal. It would apply to product categories such as electronic and electrical equipment, machinery 
and toys, but not to product categories which had been initially considered, such as batteries, paints, 
textiles and  footwear. The interlocutor would have to provide information to the authorities on 
request and cooperate with them but would not be liable for non -compliance of the product. This 
liability for non -compliance would remain on the manufacturer in accordance with the current 
applicable regulatory framework in the EU.  
3.92.   The representative of the EU went on to note that exceptions based on the type or size of 
economic operators could not be justified because this would fail to address the problem and create 
unfair  competition between economic operators. However, for offers for sales online, the EU 's 
                                                
24 For previous statements follow the thread under IMS ID 557  (under dates raised and references).  
25 For previous statements follow the thread under IMS ID 565  (under dates raised and references) . G/TBT/M/77  
 
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  requirements would only apply if sales were targeted at EU end -users. The Regulation would also 
streamline the powers of market surveillance authorities that would be b ound by the principle of 
proportionality in the exercise of their duties. It would, as of mid -2021, give sufficient time to 
implement the new requirement for products where there was not yet any such interlocutor in the 
EU. Once the legislative procedure w as finalised, the European Union would keep Members duly 
informed about the adoption of the final measure.  
3.4.10   Chile — Public Consultation for draft legislation setting out rules on the 
preparation, description and labelling of milk products deriving from milk, 
G/TBT/N/CHL/442  (IMS  ID 56626) 
3.93.   The representative of the European Union  reiterated previously raised concerns.27 
3.94.   The representative of New Zealand  said that her delegation ackno wledged and supported 
Members' right to regulate to achieve legitimate health objectives,  including Chile's efforts to protect 
the health of consumers. However, New Zealand considered that Chile's specific proposed legislation 
was not consistent with CODEX  Standards and, consequently, that it constituted an unnecessary 
barrier to trade. New Zealand urged Chile to correct such inconsistencies. In New Zealand's view, 
Chile's proposed measure was inconsistent with CODEX standards for the following reasons:  
a. It did not allow cheeses made from milk powders, or from other products obtained from 
milk, to be labelled as "cheese" but only as "milk product similar to cheese". This would 
mean that cheese made from products other than milk, such as milk powders, would n ot 
be allowed to be commercialised as "cheese", which was inconsistent with Codex General 
Standard for Cheese, CODEX STAN 283 -1978. According to CODEX STAN 283 -1978 
raw materials for cheese manufacture should be "milk and/or products obtained from 
milk". T his Codex Standard placed no restriction on the use of milk powders and/or other 
products obtained from milk as raw materials for cheese production.  
b. It contained unclear definitions for "milk" and "reconstituted milk". It also included new 
terms that were  not, however, defined, such as "liquid milk" or "milk enhanced with 
reconstituted powdered milk". Furthermore, the proposed definitions did not align with 
CODEX STAN 206 -1999 (Codex General Standard for the Use of Dairy Terms).  
3.95.   The representative of Chile stated that this draft was currently still being considered by the 
legislative congress. Chile would keep Members informed on the progress of this piece of legislation 
currently under discussion in its congress.  
3.4.11   Kingdom of Bahrain, State of Kuwait, Qatar , Kingdom of Saudi Arabia, Oman, 
United Arab Emirates, Yemen — GCC Technical Regulations for the Restriction of the use 
of certain Hazardous Substances in electrical and electronic equipment (IMS ID 57228) 
3.96.   The representative of the United States  thanked GCC members for acknowledging receipt of 
US industry comments submitted on 25 May 2018 and for confirming that they were being taken 
into account. The US was still awaiting acknowledgement that the appropriate authorities had 
received the US Gover nment comments of October 2018 and asked for confirmation that the 
regulation was still undergoing review and revision. She reiterated the concerns raised in the 
previous meeting.29 
3.97.   The representative of the European Union  supported the comments made by the  United 
States. In March 2018, the GSO had notified the draft of GCC Technical Regulations for the 
Restriction of the use of certain Hazardous Substances in electrical and electronic equipment. The 
EU had commented on the draft text, to which the GSO had r esponded in July 2018. However, there 
remained uncertainties in terms of requirements as well as timing of adoption and entry into force.  
Firstly, there was uncertainty about the process and timelines to transpose requirements into 
national legislation. Th e EU sought clarification on when the measure would be transposed in each 
individual country and whether it would replace existing regulation. Second, a longer transition 
                                                
26 For previous statements follow the thread under IMS ID 566  (under dates raised and references) . 
27 G/TBT/M/76 , paras. 3.9 -3.10. 
28 For previous statements follow the thread under IMS ID 572  (under dates raised and references) . 
29 G/TBT/M/76 , paras. 3.28 -3.29. G/TBT/M/77  
 
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  period to adapt would ensure a smoother implementation for economic operators. Third,  there 
remained uncertainty regarding the requirements for declaration of conformity. The proposal 
appeared to include a mandatory third -party conformity assessment, which would deviate from 
common international practice. The EU therefore urged GCC members  to accept conformity 
assessments already done in the EU for these products, in order to avoid the administrative burden 
and costs of approval by third party assessments. Fourth, the EU sought clarification on whether 
conformity assessments approved for on e GCC member state would be recognized in others.  If this 
was not already the case, the EU urged the GCC to ensure that this would be possible. Finally, the 
EU was concerned by the lack of clarity regarding the scope. Annex 1 seemed to provide an 
exhaustiv e list, but this had not been confirmed. The EU asked that GCC members clarify these 
uncertainties as soon as possible.  
3.98.   The representative of Oman , speaking on behalf of GCC member states, said that the measure 
was intended to regulate electrical and elec tronic equipment with a view to contributing to the 
protection of human health and the environment, including the environmentally sound recovery and 
disposal of waste. It was also intended to harmonize the GCC approach to hazardous substances in 
electrical  and electronic equipment. Since the notification of the draft regulation in March 2018, the 
GCC had been receiving a series of questions, most recent of which was from the US in October 
2018. He acknowledged that more time would be required to review the responses that they had 
just submitted that day. Regarding the questions and comments posed by the EU, he asked that 
they be provided in written form so that they could be transmitted to the GSO for their consideration. 
He reiterated their readiness to dis cuss any further questions bilaterally.  
3.4.12   China - Insurance Regulatory Commission (CIRC) Information and Communication 
Technology Regulation  (IMS ID 48930) 
3.99.   The representative of the European Union  referred to the comments made in previous TBT 
Committee meetin gs and reiterated the concerns raised in the November 2018  meeting .31  
3.100.   The representative of the United States  said her delegation remained very concerned with 
China's suite of measures that appeared to discriminate against foreign technologies and companie s 
in the name of information security. These included the Cybersecurity Law and the draft Insurance 
Sector Informatization Rules, amongst others. The US shared the concerns of the EU and looked 
forward to continued discussion on this important issue with C hina.  
3.101.   The representative of China  informed the Committee that following the merger of the former 
CBRC and CIRC, it was necessary to draft the Information and Communication Technology 
Regulation . China always abided by its WTO commitment and was open and t ransparent when 
drafting information technology measures in the banking and insurance sectors, where domestic and 
foreign companies were treated equally.  
3.4.13   Indonesia — Halal Product Assurance Law No. 33 of 2014 (IMS ID 50232)  
3.102.   The representative of the United States  reiterated concerns raised in the previous TBT 
Committee meeting.33 
3.103.   The representative of the European Union  raised  concerns regarding the Indonesian Halal 
Product Guarantee Law No 33 of September 2014 . The full statement is contained in G/TBT/W/630 . 
3.104.   The representative of Brazil  reiterated concerns raised in the pre vious TBT Committee 
meeting.34 He express ed his delegation's  interest in participat ing in any future public consultations 
regarding this issue.  
3.105.   The representative of New Zealand  requested that Indonesia update the Committee on the 
implementation of the Mand atory Halal Law. Regarding the implementation timeframes, New 
Zealand request further information on the phased implementation across different products for 
                                                
30 For previous statements follow the thread under IMS ID 489  (under dates raised and references) . 
31 G/TBT/M/76 , para. 3.41 and G/TBT /W/567 . 
32 For previous statements follow the thread under IMS ID 502 (under dates raised and references) . 
33 G/TBT/M/76 , para s. 3.108 -3.110 . 
34 G/TBT/M/76 , para . 3.11. G/TBT/M/77  
 
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  when certification w ould become mandatory. Further information on the timeframe for the transition 
of responsibilities to Indonesia 's Halal Product Assurance Agency (BPJPH) and the steps taken to 
ensure continued recognition of foreign halal certification  was also requested . New Zealand would 
welcome any updates on the discussions that were ongoing amon gst government institutions 
regarding the inclusion of information on non -halal products . 
3.106.   The representative of Australia  said it was understood that Indonesia 's Halal Product 
Assurance Law No.33 of 2014 would take effect from 17 October 2019, with a likel y phased 
implementation period of between five to seven years. Australia recogni zed the importance of halal 
product assurance to many Indonesian consumers and requested the most recent version of the 
Halal Law be provided in advance of its implementation t o ensure all trading partners had time to 
prepare and adjust to the changes. Australia encouraged Indonesia to establish an open dialogue 
with trading partners to ensure foreign businesses and their valued Indonesian importers remained 
adequately informed of new requirements under the Halal Law. Australia looked forward to joint 
cooperation to ensure a smooth implementation of the Halal Law and minimise any disruptions to 
existing trade. Australia welcomed Indonesia's statement at the previous TBT Committee  meeting 
that the proposed regulation would be in line with the TBT Agreement and would take into account 
trading partners ' concerns to ensure the requirements were not more trade restrictive than 
necessary.  
3.107.   The representative of Canada  said that Canada w as also following developments regarding 
the implementation of the Halal product assurance law and thank ed Indonesia for the bilateral 
meetings . He reiterate d, like other Members, Canada's  interest in a clear operating environment for 
exporters and asked what the timeline for implementation of the law and for the phase -in was. 
3.108.   The representative of Indonesia  emphasized that this law was to provide certainty to 
Indonesian society about halal products, rather than prohibiting the sale and circulation o f non-halal 
products. As the country with the largest Muslim population in the world, it was necessary for product 
information to be sufficient to ensure halal integrity. As the implementation provision of Law No 
33/2014, implementing and technical regulat ions under that Law were currently under discussion 
and/or finalisation. The technical regulation would include the scope of halal -mandatory products, 
the transition process, labelling of halal products and Mutual Recognition Arrangements (MRAs) for 
halal certification scheme. Indonesia believed that in fulfilling halal certification, mutual recognition 
and acceptance were necessary between interested parties so as to reduce any unnecessary 
technical barrier. Thus, Indonesia was fully committed to applying the principles of mutual 
recognition and acceptance of the certification process carried out by certification bodies outside 
Indonesia with the proviso that the certification bodies outside Indonesia were either accredited by 
accreditation bodies with an M RA with KAN (Indonesia Accreditation Body) or had signed a mutual 
acceptance cooperation with the Indonesian Government based on mutual reciprocity principles.  
3.109.   To provide enough information for the consumer, Indonesia need ed to ensure that all halal -
manda tory products complied with the required halal labelling. Nonetheless, to reduce any 
unnecessary cost and barrier for imported products, Indonesia would allow the use of halal -labels 
from certification bodies that were mutually recognized and accepted by I ndonesia as long as a 
registration number from BPJPH was included in the products. Products containing non -halal 
ingredients could still circulate, enter, and trade in Indonesia by including non -halal information 
complying with the regulation of The Head o f National Agency for Drug and Food Control Republic 
of Indonesia No. HK.03.1.23.06.10.5166 Year 2010 concerning inclusion of the Information on 
Particular Substances, Alcohol Content and Expired Date on The Label of Drug/Medicine, Traditional 
Medicines, C omplementary Medicines, and Food. Indonesia assured the Committee that the 
implementation of the Law would not limit people's freedom to choose their desired products.   
3.4.14   Russian Federation – Rules of cement certification, G/TBT/N/RUS/48 , 
G/TBT/N/RUS/49  (IMS ID 49735) 
3.110.   The representative of the European Union  continued to raise concerns with the Russian 
Federation's measures on rules of cement certi fication. The full statement is contained in 
G/TBT/W/631 . 
                                                
35 For previous statements follow the thread under IMS ID 497  (under dates raised and references).  G/TBT/M/77  
 
- 20 - 
 
  3.111.   The representative of Ukraine  shared the EU's concerns and repeated its statement made in 
previous Committee meetings with regard to the clearly overly restrictive certification requirements 
for cement. Her delegation asked the Russian Federation to take t he concerns expressed into 
consideration to ensure that the requirements and rules were in line with Russia's obligations under 
the TBT Agreement and did not cause unnecessary obstacles to trade.  
3.112.   The representative of Mexico  recalled her delegation's syste mic interest in the issue.  
3.113.    The representative of the Russian Federation  stated that amendments to GOST -R "Rules of 
cement certification" abolishing additional border inspection were currently being discussed 
internally between different Russian authorities but that precise timeline for the outcome of the 
discussions could yet  be provided. He indicated that a notification would be made to the WTO and 
that his delegation was ready to discuss the issue bilaterally.  
3.4.15   China — Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Pro ducts and Services  (IMS  ID 53336) 
3.114.   The representative s of Japan  and the United States  reiterated previously raised concerns .37 
3.115.   The representative of the European Union  reiterated previously raised concerns.38 
3.116.   The representative of China  informed the Committee that the measure which established 
the review mechanism of cyber security had been  released in May 2017 to improve the secure and 
controllable level of network products and services, prevent the security risk of the supply chain, 
safeguard national cyber s ecurity and protect the interest of the people. China clarified that the 
system was also conducive to increas ing the confidence of the market and the consumers on 
products and services of the information technology. Moreover , not all products and services 
required review, the focus was on those that would affect national security applied in critical 
information infrastructures and important information systems. As such, he stated that the security 
review would  not violate the intellectual property right of enterprises as the Chinese government 
attached great importance to IPR protection and protect ed IPR in accordance with the law. He 
remarked that great efforts ha d been made to ensure that there were no violations of enterprise IPR 
in any form and as such t he review would not damage commercial secrets of enterprises as well as 
the IPR. China concluded by stating that there were no national differences in the review and it could 
help increase the confidence of consumers in the products and expand the market s pace of the 
enterprises.  
3.4.16   China — Draft revised Encryption Law of the People's Republic of China by the 
Office of State Commercial Cryptography Administration (OSCCA) (IMS ID 53439) 
3.117.   The representative of the United States  reiterated previously raised concern s.40 
3.118.   The representative of the European Union  reiterated  previously raised  concerns with China's 
draft revised Encryption Law .41  The full statement is contained in G/TBT/W/632 . 
3.119.   The representative of Japan  requested China to update Members o n the status of revision to 
the draft Encryption Law, and in addition, to clarify whether the following four points pointed out by 
her delegation in previous meetings were reflected in the revised draft.42 First, to clarify the 
definitions of terms, the con crete requirement for review and the scope of regulation. Second, to 
clarify the relevance of this Encryption Law to existing security regulations such as the "the 
Cybersecurity Law". Third, to ensure that foreign company market access in China dealing in 
cryptography -utilizing products would not be hampered and that confidential technology would not 
                                                
36 For previous statements follow the thread under IMS ID 533  (unde r dates raised and references) . 
37 G/TBT/M/76 , para. 3.161.  
38 G/TBT/M/76 , para. 3.162 and G/TBT/W/593 . 
39 For previous statements follow the thread under IMS ID 534  (under dates raised and references) . 
40 G/TBT/M/76 , paras. 3.166 –3.167.  
41 G/TBT/M/76 , para. 3.165 and G/TBT/W/593 . 
42 G/TBT/M/76 , para. 3.165; G/TBT/M/75 , para. 4.183; G/TBT/M/74 , para. 2.218 and G/TBT/M/73 , 
paras. 2.19 –2.21.  G/TBT/M/77  
 
- 21 - 
 
  be leaked. Fourth, to ensure that the development of relevant regulations and procedures were 
consistent with international standards and practices.  
3.120.   The repres entative of China  said that China w ould press forward with the legislation of the 
Law on Cryptography in accordance with the Legislative Law and adhere to the principles of law -
making in a well -conceived and democratic way and in accordance with law. China  would carry out 
scientific verification and public consultation to ensure stakeholders participate in the legislative 
activity through legal channels . The Law on Cryptography (Draft for consultation) ha d been released 
in April 2017 for public consultation . Domestic and foreign parties ha d provided many constructive 
suggestions. China was actively researching and adopting the relevant suggestions from all parties 
and pressing ahead with further revision of the Draft, which w ould further reduce the number of  
administrative licenses and regularize market access . 
3.4.17   European Union — Amendments to the Directive 2009/28/EC, Renewable Energy 
Directive (IMS ID 55343) 
3.121.   The representatives of Indonesia , Colombia  and Malaysia  raised concerns with the European 
Union's Renew able Energy Directive. The full statements are contained in G/TBT/W/615 , 
G/TBT/W/602  and G/TBT/W/598 , respectively.  
3.122.   The representative of Ecuador  supported the posit ion of Indonesia, Colombia and Malaysia, 
and welcomed the analysis conducted. Ecuador acknowledged  that the EU was seeking to meet its 
climate -related goals, along with all signatories of the Paris Agreement, working as they were in 
accordance with their o wn national agendas to eliminate deforestation from supply chains, as part 
of their commitment to, and support for, mitigating the effects of climate change. However, the rural 
development capacities of a predominantly agricultural country should not be li mited, and the 
restriction of trade through the extrajudicial application of national agendas based on 
non-consensual measures was not justified by a legitimate environmental objective.  
3.123.   Like Colombia, Ecuador consider ed that the criteria established would directly affect palm  oil 
but not fuels produced from other types of vegetable oil . This was inconsistent with the obligation 
contained in Article 2.1 of the TBT Agreement and Article  I:1 of GATT  1994. Furthermore, since the 
proposal favour ed vegetable oils  produced in the E U, it also violate d the principle of national 
treatment contained in Article 2.1 of the TBT Agreement and Article III:4 of the GATT  1994.  
3.124.   The act, established pursuant to Article 26 of the Directive, provide d for specific standards 
on bio fuels, bioliquids and biomass fuels produced from food or feed crops, to address emissions 
produced by indirect land -use change (ILUC). This methodology and the characterizations applied 
through the establishment of general, specific and additionality crit eria for the certification of 
biofuels, bioliquids and biomass fuels were not subject to multilateral negotiations within the 
framework of the Paris Agreement, which was the source of the main commitments of the European 
Directive.  
3.125.   The ILUC methodology was not extensively discussed at the international level. The 
methodology was unclear and ha d not been endorsed by international experts or sufficiently 
disseminated, and therefore was considered as a new technical requirement that would covertly 
affect palm  oil production and marketing processes. Ecuador requested that the EU comply with the 
WTO principles of transparency and harmonization.  
3.126.   To date, the European Commission ha d not included the ILUC methodology in its calculations 
of greenhouse gas emissions, and therefore fail ed to comply with the principle of national treatment. 
She said t hird countries should not be  expected to apply a methodology that provide d no certainty 
regarding the hypotheses used, benchmarks for palm  oil plantations, estimates of gree nhouse gas 
emissions in the production of palm oil, or projections concerning the types of land to be used for 
the expansion of palm oil crops.  
3.127.   Lastly, it was important to underscore the significant progress Ecuador had made  in reducing 
emissions and  was currently a leader in the implementation of actions and measures for reducing 
emissions from deforestation and forest degradation (REDD+). This commitment had already  been 
                                                
43 For previous statements follow the thread under IMS ID 553  (under dates raised and references).  G/TBT/M/77  
 
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  made by the Ecuadorian palm -growing sector, which signed an agreement to move towar ds 
deforestation -free production, with clear zero -deforestation goals and commitments.  
3.128.   Ecuador was second globally in meeting  the requirements established by the UN Framework 
Convention on Climate Change to gain access to performance -based payments. It was therefore 
fundamental that such achievements made in the context of international agreements be taken into 
consideration when establishing this type of restriction.  
3.129.   Ecuador had set itself the goal of reducing emissions from deforestation and ha d achieved 
it. Its average gross annual rate of deforestation was 94,353 hectares in the period 2015 -2016, 
compared with 129,943 hectares in the period 1990 -2000, representing a decrease of 27%, and a 
reduction of over 29  million tonnes of CO² equivalent between 2009  and 2014.  She requested that 
the EU pursue dialogue with palm -oil producing countries, so as to take into account the efforts that 
had been made and ensure these efforts were reflected in legislation.  
3.130.   The representative of Costa Rica  supported the concern s raised by Colombia, Indonesia and 
Malaysia regarding the amendments to Directive 2009/28/EC on renewable energy. He expressed 
concern regarding the proposed criteria for determining indirect land use change and identifying a 
low risk of indirect land use  change with regard to biofuels. He underscored that Costa Rica was a 
pioneering and committed country in the field of environmental protection. It was one of the few 
countries that had been able not only to carry out reforestation, but also to reverse the  trend of 
deforestation. Costa Rica had one of the few coal -free electrical systems in the world. In 2017, 
99.5% of electricity in Costa Rica was generated without using fossil fuels, which was the highest 
percentage in 30 years. While Costa Rica clearly w elcomed the efforts of the European Union to 
establish an appropriate policy on the use of renewable energy, such efforts should not be allowed 
to damage the marketing conditions for products based on criteria that lacked scientific 
substantiation. Based o n the introduction of the concept of biofuels with a low risk of causing indirect 
land use change, the EU would be able to recognize the singularity of palm oil cultivation in Costa 
Rica and other areas in Latin America.  
3.131.   The representative of Guatemala , as a palm oil -producing country supported the concerns 
raised by other delegations. While this measure did not limit the use of palm oil, it did discourage 
its use, thereby discriminating against palm oil as opposed to other vegetable oils and in particular 
oils produced by the European Union, putting palm oil at a disadvantage. In 2017, palm oil was 
Guatemala's sixth main export. The EU was one of its main markets for palm oil and these new 
measures would have a major impact on bilateral trade. The palm oil agro-industry in Guatemala 
accounted for some 28,000 direct jobs, particularly in rural areas, and 85,000 families within the 
country benefitted from its production.  
3.132.   The production sector was making the necessary efforts to generate sustainable production, 
implementing policies at the private sector level and estimating greenhouse gas (GHGs) emissions 
in palm oil production, thus demonstrating the priority given and it s commitment to these issues. 
Furthermore, Guatemala thought it necessary to differentiate between palm oil production and 
production conditions. The global production of palm oil could not be condemned and along with it 
the many families whose daily livel ihood depended on this crop. Guatemala reiterated its 
commitment to meeting the UN SDGs, and its support for sustainable palm oil certification with a 
view to meeting the Millennium Goals . 
3.133.   The decision made by the Trilogue (European Commission, European Pa rliament and Council 
of Europe) and its final approval in 2019 was worrying, especially as some palm oil -producing 
countries had requested a hearing with the Presidents of the Trilogue but had not received a positive 
reply in writing to enter into dialogue . Guatemala was concerned about the negative impact of these 
measures and the lack of transparency in the process. Guatemala would continue to participate 
actively in the TBT Committee and in Brussels on this measure so as to prevent the establishment 
of discriminatory measures, in accordance with WTO principles . 
3.134.   The representative of Thailand  once again registered interest in this matter and called for 
equitable treatment of palm oil to other oil crops. Thailand appreciated receiving the EU's updated 
information and looked forward to further clarification on the questions raised by Members.  G/TBT/M/77  
 
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  3.135.   The representative of the European Union  noted that the revision of the Renewable Energy 
Directive had also been discussed in several bilateral meetings among experts. T he official text of 
the revised RED had been  published on 21 December 2018, providing further clarity on concerns 
raised, notably on the fact that the Directive did not impose a ban on, or otherwise single out, any 
specific biofuel. In this regard, and as stated on many occasions, the RED as such did not appear to 
fall within the scope of the TBT Agreement. In line with the RED, the Commission had prepared a 
draft Delegated act to supplement the Directive as regards the determination of high indirect land -
use change -risk feedstock for which a significant expansion of the production area into land with 
high carbon stock was observed and the certification of low indirect land use change -risk biofuels, 
bioliquids and biomass fuels. The draft Delegated Act conta ined further details regarding the 
determination of ILUC. A public consultation was currently ongoing on the draft Delegated Act and 
was open for feedback until 8 March 2019.The EU remained available for discussions through the 
appropriate bilateral channe ls. 
3.4.18   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 Tel ecommunications, No. 10 -15/2009 -
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and 
Business Continuity Agreement") , G/TBT/N/IND/66  (IMS ID 27444) 
3.136.   The representative of the European Union  expressed her appreciation for the clarifications 
and explanations provided by India at previous meetings. She asked for clarification on the effective 
date of entry into force of the testing requirements. India had published several notifications that 
specified products for which in -country testing and certification would be made mandatory. The EU 
stressed the need to allow adequate time before the entry into force of these requirements in order 
for affected stakeholders to have an opportunity to review t he final requirements, including any 
applicable standards and procedures. The EU was concerned about an announcement regarding the 
extension of the requirement of in -country testing/certification to all equipment to be connected to 
Indian networks, beyond the telecom network elements. She asked whether India could confirm this 
information and if so, indicate the relevant international standards and how legal predictability would 
be ensured in the meantime. On the recognition of test results carried out outs ide India, the EU 
reiterated its concerns that mandatory in -country testing did not appear to add any value in terms 
of safety of the covered equipment. A delegation from the Indian Department of Telecommunications 
was expected to visit the EU during the l ast week of March to see the operation of the EU system 
and discuss possible recognition instead of in -country testing.  
3.137.   The representative of the United States  referred the Committee to the statement made at 
the November 2018 meeting.45 
3.138.   The representative o f Canada  indicated that his delegation  continue d to have concerns about 
India's in-country security testing requirements. The ongoing delays in implementing the measure 
demonstrate d that the Indian government was aware of the supply chain problem this requ irement 
could create.  He asked whether  India would reconsider its approach and adopt the international best 
practice of using international common criteria and accepting products tested in any accredited lab, 
whether located in India or elsewhere . 
3.139.   The repr esentative of Japan  reiterated concerns raised in previous TBT Committee 
meetings.46 
3.140.   The representative of India responded to the concerns raised. The full statement is contained 
in G/TBT/W/621 . 
                                                
44 For previous statemen ts follow the thread under IMS ID 274  (under dates raised and references) . 
45 G/TBT/M/76 , para . 3.36. 
46 G/TBT/M/76 , para. 3.37. 
 G/TBT/M/77  
 
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  3.4.19   China — Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administratio n (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS)  (IMS ID 29447) 
3.141.   The representative of Japan  reiterated concerns raised at the previous TBT Committee 
meeting.48 In addition, Jap an requested that China notify the draft to the WTO in order to allow 
Members the opportunity to comment.  
3.142.   The representative of the European Union  reiterated concerns on China's new Cybersecurity 
Law for the existing rules, notably the Multi -Level Protecti on Scheme ('MLPS'). The full statement is 
contained in G/TBT/W/633 . 
3.143.   The re presentative of Australia  reiterated concerns raised in previous TBT Committee 
meetings.49 Australia understood China's desire to protect ICT infrastructure but continued to 
question whether the proposed measures were not more trade restrictive than necessary.  
3.144.   The representative of China  informed the Committee that China was organizing the rev ision 
of the Regulations on Commercial Cryptography to further reduce the administrative licenses and 
strengthen supervision in the whole process so as to implement the requirements of promoting 
administration according to law, deepen the administrative re form and transform government 
functions in the domain of commercial cryptography. The revision of the Regulations on Commercial 
Cryptography had not yet been finalized. After the promulgation of the Law on Cryptography, China 
would continue to revise the R egulations on Commercial Cryptography according to the Law on 
Cryptography and release the regulations for public consultation at an appropriate time. As IT 
developed, information security multi -level protection schemes needed to be improved to meet the 
increasingly complicated cyber security circumstances. Based on experiences over the previous 
years and responding to new development, the Cybersecurity Law stipulated that China would carry 
out the cybersecurity MLPS, which was based on the information secu rity MLPS. To fulfil the 
requirements in the Cybersecurity Law, regulations on the cybersecurity MLPS were being drafted, 
which would replace the former administrative measures on the information security MLPS. When 
completed, the regulation would be open for comments . 
3.4.20   Russian Federation — Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011) , G/TBT/N/RUS/2  (IMS ID 33250) 
3.145.   The representative of the European Union  reiterated concerns on  the Russian Federation's 
technical regulations on alcohol products safety . The full statement is contained in G/TBT/W/634 .  
3.146.   The representative of Ukraine  reiterated its request that this meas ure be adjusted so that it 
complies with the TBT Agreement transparency requirements and in in line with international 
practices.  
3.147.   The representative of the Russian Federation  informed the Committee that the Technical 
Regulation had been  adopted on 5 December 2018 and  would enter into force on 5 January 2021. 
Alcohol Drinks Safety Technical Regulation s were not uniform across the alcohol sector . Some 
international companies including those based in Europe , specifically in the beer sector, publicly 
supported the new regulation as it would make alcohol companies in Russia more flexible. Companies 
would be  able to offer more types of products and better satisfy consumer needs. With regards to 
concerns raised about inappropriate use of EU Geographical indi cations, he stressed that  this 
technical Regulation d id not confine the  rights to register geographical indicat ors in the Russian 
Agency of Intellectual Property and their consequential use . He questioned the relevance to the TBT 
Agreement of the EU concer n on the non -recognition of EU production practices . Russia looked 
forward to continue d constructive engagement  with interested Member s and the comments and 
concern s raised would be conveyed to the regulatory authorities in Moscow.  
                                                
47 For previous statements follow the thread under IMS ID 294  (under dates raised and references) . 
48 G/TBT/M/76 , para. 3.40. 
49 G/TBT /M/76 , para. 3.43; G/TBT/M/75 , para. 4.47; G/TBT/M/74 , para. 2.68; G/TBT/M/73 , para . 2.22; 
G/TBT/M/72 , para. 3.75; G/TBT/M/71 , para. 2.162; and G/TBT/M/71 , para. 2.175.  
50 For previous statem ents follow the thread under IMS ID 332  (under dates raised and references) . G/TBT/M/77  
 
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  3.4.21   India — Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IND/44 , G/TBT/N/IND/44  Add.1 -5, 
G/TBT/N/IND/47 , G/TBT/N/IND/47/Add.1 -3, G/TBT/N/IND/47/Add.1/Corr.1  (IMS  ID 36751) 
3.148.   The representative of the United States  referred the Comm ittee to statements delivered in 
previous TBT Committee meetings.52  
3.149.   The representative of Canada  supported the concerns raised by others and sought 
clarification as to whether it was now the case that only the Indian company importing the good, 
not any Ind ian company, could apply for registration. Given that India had indicated that it was open 
to MRAs with foreign labs, he asked how many MRAs had been signed by the BIS.  
3.150.    The representative of India responded to the comments made. The full statement is 
contained in G/TBT/W/622 . 
3.4.22   European Union — Hazard -based approach to plant pro tection products and setting 
of import tolerances G/TBT/N/EU/383 , G/TBT/N/EU/383/Add.1 , G/TBT/N/EU/384 , 
G/TBT/N/EU/384/Add.1 , G/SPS/N/EU/166 , G/SPS/N/EU/166/Add.1  (IMS ID 39353) 
3.151.    The representative from Canada  reiterated previously raised concerns54 and stated that her 
delegation remained concerned with the trade implications of the hazard -based approach taken b y 
the EU on the regulation of active substances in plant protection products. Canada recognized 
Members ' right to implement measures to achieve legitimate policy objectives, such as the protection 
of human health and safety, or protection of the environmen t, provided such measures are no more 
trade restrictive than necessary. Finally, Canada requested the EU to provide any available 
information indicating how the EU planned to work with trading partners to avoid unnecessary 
disruptions to trade.  
3.152.   The representative of Argentina  referred the Committee to concerns raised at previous 
sessions regarding Commission Regulation (EU) 2018/605 (criteria for the determination of 
endocrine disrupting properties).55 The representative of Argentina requested the  Commission, in 
regard both to substances with endocrine disrupting properties and to any other substance coming 
under the cut -off criteria, to maintain MRLs and the application of import tolerances on the basis of 
risk assessments, having regard to the pr ovisions of Regulation No. 396/2005 because otherwise, 
this measure would lead to the creation of more significant, unnecessary and disproportionate 
barriers to international trade in agricultural products, without any scientific justification.  
3.153.   The represe ntative of the United States  reiterated concerns raised in previous meetings56 
and noted that the EU ha d proceeded with implementing the regulations despite 15 interventions by 
WTO Members at previous Committee meetings. The US remained concerned with the E U's hazard -
based approach to pesticide regulation, its implementation of criteria for identifying and 
subsequently banning endocrine -active substances and with the EU 's opaque process for managing 
import tolerances for substances that triggered the hazard -based cut -off criteria. In light of the 
concerns raised, the representative of the US requested the EU to explain its objectives as identifying 
hazards without identifying ascertainable risks or considering reasonable methods for managing risk 
raised conce rns that could be more trade -restrictive than necessary.  
3.154.   The representative of Paraguay  raised previously raised concerns and stated that her 
delegation remained concerned with the series of decisions taken by the EU not to renew the 
approval of substance s and to amend the MRLs of these substances, without considering risk 
assessments or ensuring compliance with the Codex Alimentarius standards. Moreover, Paraguay 
was further concerned by the fact that the European Food Safety Authority (EFSA) did not obta in 
conclusive results regarding the risk assessment of certain substances because the data in the 
dossier was insufficient, which implied that the result was not decisive. The representative of 
Paraguay reiterated concerns raised in the last session of the  Committee, and in the SPS Committee, 
                                                
51 For previous statements follow the thread under IMS ID 367  (under dates raised and references) . 
52 G/TBT/M/76 , para. 3.59; G/TBT/M/75 , para.  4.67; and  G/TBT/M/74 , para.  2.89. 
53 For previous statements follow the thread under IMS ID 3 93 (under dates raised and references) . 
54 G/TBT/M/76 , para. 3.62 and the full statement contained in G/TBT/W/588 . 
55 G/TBT/M/76 , para. 3.62 and the full statement contained in G/TBT/W/563 .  
56 G/TBT/M/76 , para. 3.63; and G/TBT/M/75 , para . 4.71 and  full statement contained in G/TBT/W/541 . G/TBT/M/77  
 
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  regarding the use of a hazard -based  approach to regulate these substances because it would result 
in unnecessary barriers to trade and would  adversely affect producers. Her delegation noted that at 
the last meeting of the Committee, this STC had been raised by 15 delegations, and in the Committee 
on SPS Measures held in November 2018, 21 delegations had expressed concern about  the matter, 
howe ver, the EU was yet to provide a response. Paraguay requested the EU to perform full risk 
assessments, avoid unnecessary trade restrictions, and provide reassurance to Members regarding 
the policy on import tolerances.  
3.155.   The representative of Costa Rica  supported the concerns raised by other Members and 
reiterated his continuing  concern with the approach taken by the EU to implement Regulation (EC) 
No. 1107/2009, which led to the adoption of a hazard -based  decision criterion. Cost a Rica requested 
the EU to en sure that the implementation of this Regulation was based on the use of risk 
assessments for the identification and regulation of endocrine disruptors, through the application of 
criteria supported by sufficient scientific evidence, in line with the commit ments established in the 
TBT Agreement .  
3.156.   The representative of Brazil  reiterated previously raised concerns.57 
3.157.   The representative of India reiterated previously raised concerns .58 In addition, India 
requested the EU to withdraw the hazard -based measure or co nsider other options available within 
the WTO SPS framework.  
3.158.   The representative of Thailand  reiterated previously raised concerns and stated that 
although her delegation supported the EU 's right to take necessary measures to protect human 
health and the en vironment, such measures should be based on risk assessment and harmonized 
with relevant international standards. Thailand remained concerned with the implementation of the 
hazard cut -off criteria for identifying substances having endocrine disrupting prop erties might affect 
the MRLs of previously authorized substances, which would constitute a disguised restriction on the 
international trade.  The representative of Thailand therefore requested the EU to establish the MRLs 
and import tolerance of endocrine d isrupting substances according to the principle of risk assessment 
to adopt the existing international standard MRLs to minimize the adverse impact on trade. 
Furthermore, Thailand requested the EU to expedite the drafting process of the criteria for deroga tion 
by determining the meaning and criteria for negligible risk and notify it to WTO for comments.  
3.159.   The representative of Uruguay  supported the concerns raised by other Members and stated 
that his delegation remained concerned with the use of a hazard -based approach by the EU which 
did not respond to scientific evaluation of the risk-based  methodology.  
3.160.   The representative of Colombia  supported the concerns raised by other Members and 
reiterated previously raised concerns.59 Colombia also highlighted the imp ortance of performing a 
risk analysis, a methodological tool for decision making with three main components: assessment, 
management and communication, with regard to pesticide use, in order to protect public health and 
the environment, and as a means of fa cilitating international trade in agricultural products. Her 
delegation argued that upon examination of the proposal by the EU, it appeared that a risk 
assessment was deemed irrelevant, and instead a hazard -based  approach had been  adopted with 
regard to th e decision to accept or allow the use of substances, which meant that the conditions of 
use that may identify risk scenarios and allowed for science -based  decisions to be made had been  
overlooked. The representative of Colombia requested the EU proposal to  take into account scientific 
evidence, production processes and methods, the international recommendations of the Codex 
Alimentarius on MRLs, and the relevant ecological and environmental conditions in countries that 
may be affected by the implementation of the measure, in order to avoid creating unnecessary 
technical barriers to trade. The representative of Colombia also stated that her delegation remained 
concerned that these measures encourage d the gradual extension of the approach to other areas of 
sanitary regulation, which would have a significant and widescale impact on international trade in 
agricultural products and  would entail a greater degree of restriction on trade than necessary to 
achieve the appropriate level of sanitary protection sought by  the EU.  
                                                
57 G/TBT/M/76 , para. 3.67. 
58 G/TBT/M/76 , para. 3.75.  
59 G/TBT/M/76 , para. 3.66.  
 G/TBT/M/77  
 
- 27 - 
 
  3.161.   The representative of Guatemala  reiterated previously raised concerns60 about the EU 's 
policy for identifying endocrine disruptor criteria, particularly because it lacked any scientific basis, 
and requested the EU to clarify the options under consideration to avoid blocking trade and 
agricultural exports.  
3.162.   The representative of Australia  reiterated previously raised concerns61 regarding the 
importance of adopting a risk -based approach for regulating endocrine disrupting chemicals (EDCs) 
rather th an considering only the potential for harm due to the intrinsic properties of a chemical.  
3.163.   The representative of Panama  recalled  previously raised concerns62 regarding the 
unnecessarily trade restrictive measures that were hazard based and not risk assessed . His 
delegation requested the EU to align the measures with the Codex so that it would  not unnecessarily 
obstruct trade.  
3.164.   The representative of the European Union  repeated responses provided in the previous 
Committee meeting63 and stated that his delegation  was aware of concerns regarding the EU policy 
on plant protection products for the definition of scientific criteria to identify endocrine disruptors 
and other, more specific concerns, on whether import tolerances could be established for substances 
not a uthori zed in the EU, due to the so -called "cut-off" criteria in Regulation (EC) No 1107/2009. 
After examin ing the different policy options and taking into account the concerns raised by 
stakeholders, member States and third countries, the EU informed Membe rs that it had decided to 
follow the procedures laid down in Regulation (EC) No 396/2005 for the management of import 
tolerance requests concerning active substances falling under these cut -off criteria. According to his 
delegation, these procedures includ ed a risk assessment by an Evaluating EU member State and a 
scientific opinion by the European Food Safety Authority (EFSA). The granting of the import tolerance 
would  then be considered in line with risk analysis principles on a case -by-case basis and tak ing into 
account all relevant factors. The EU reiterate d its commitment to act in full transparency and would  
keep Members duly informed about further developments.  
3.4.23   Russian Federation — Safety of products for children and adolescents , 
G/TBT/N/RUS/29  (IMS ID 41864) 
3.165.   The representative of the European Union  reiterated concerns raised in the previous TBT 
Committee meeting .65 The EU pointed out that Amendment 2 of the measure prohibit ed the use of 
"artificial leather " in insoles for children 's shoes and relate d to the EAEU standard that provide d 
definitions of "artificial leather",  "synthetic leather" and "composition leather". In this respect, the 
EU wanted to know whether Amendment 2 prohibited all three notions listed in the EAEU standard: 
"artificial leather ", "synthetic leather" and "composition leather". The EU was concerned a bout these 
definitions as they deviate d from international standards and practices (ICT, ISO and CEN) and were 
likely to create confusion between genuine leather and textile products, notably considering that the 
definition of "artificial leather " in the E AEU standard seem ed to correspond to synthetic textiles. The 
prohibition of the use of such materials in insoles for children 's shoes would mean a ban on the use 
of synthetic or artificial materials, regardless of their chemical content and without any jus tified 
pursued health or safety objectives.    
3.166.   The representative of the Russian Federation  recalled its statement made in the previous 
TBT Committee.66 For public health reasons, the September 2018 amendments to the Technical 
Regulation prohibited the use of artificial leather in lining and insoles of children 's shoes. Artificial 
leather was defined by EAEU legislation as fabric coated or impregnated with polymer or composition 
of polymers. Use of artificial materials including textile materials except for artificial leather was 
allowed. Statistics showed that the measure had not  negative ly impact ed on Russia's shoe imports. 
                                                
60 G/TBT/M/76 , para. 3.69. 
61 G/TBT/M/76 , para. 3.64. 
62 G/TBT/M/76 , para. 3.70  
63 G/TBT/M/76 , para. 3.76.  
64 For previous statements follow the thread under IMS ID 418  (under dates raised and references) . 
65 G/TBT/M/76 , para . 3.77. 
66 G/TBT/M/76 , para. 3.78. 
 G/TBT/M/77  
 
- 28 - 
 
  In fact, Russia 's shoe imports had increased both from the EU and internationally in the fourth 
quarter of 2018 as compared with the pr evious two quarters.  
3.4.24   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 
42867) 
3.167.   The representative of the Republic of Korea  reiterated concerns raised in the previous TBT 
Committee meeting .68 
3.168.   The representative of China  said that in January of 2018, China's  Food and Drug 
Administration (CFDA) released guideline s on instructions for t he work on the acceptance of overseas 
clinical trials results as clinical evaluation materials for medical devices. Th ese guideline s would  
reduc e the duplication  and speed up the marketing process. The Regulation for the Supervision and 
Administration of Medical Devices adopted in 2014, ha d further simplified the requirements for 
registration . Firstly, they were set up to improve the classificatio n management system. Based on 
level of their risks, the medical devices fall into 3 categories as class  1, class 2 and class 3. The 
requirements for low risk products were further streamlined.  Secondly, to reduce the requirements 
on clinical trials, certa in products were exempted from clinical trials. Thirdly, to simplify the re -
registration’s requirements , following this regulation, former CFDA published an implementation 
notice, providing one -year transition period, and offering some transitional measure  for registration.  
In September of 2018, the National Medical Products Administration ha d published the new revised 
list for medical devices exempted from clinical trials,  and 1248 medical devices are exempted from 
clinical trials, including 855 medical de vices products and 393 in vitro diagnostic reagents (IVD 
reagents). 84 medical devices products were added while 277 IVD reagents were added.  
3.4.25   China – Registration Fees for Drugs and Medical Device Products  (IMS  ID 46669) 
3.169.   The representative of the Republic o f Korea  continued to have concerns with the higher 
registration fees imposed on imported medical devices compared to domestically manufactured 
ones. Such a measure was discriminatory and lacked clarity and transparency. China had responded 
that that higher  registration fees for imported medical devices were due to the on -site inspection of 
facilities overseas. However as on -site inspection of manufacturing facilities for imported medical 
devices was not mandatory, it was unreasonable to include on -site insp ection costs in the registration 
fees for all imported medical devices. Korea requested that China provide justification for its 
registration fee structure for imported medical devices, or, that China establish a fair and non -
discriminatory registration fe e framework for both domestic and imported medical devices.  
3.170.   The representative of China  informed the Committee that following the merger of the former 
CBRC and CIRC, the former CIRC ’s Information and Communication Technology Regulation  was 
drafted in respo nse to the new circumstances . China always abided by its WTO commitment and 
was open and transparent when drafting information technology measures in the banking and 
insurance sectors, where domestic and foreign companies were treated equally.  
3.171.   The represe ntative of China  said that c ollecting registration fees for drugs and medical 
devices was common practice internationally  and the 624,000 RMB Yuan  registration fee was  much 
lower than other Members. The registration fees in China were calculated on the basis of costs of 
conformity assessment works, which reflected the different workloads and pricing levels.  
3.4.26   China — Interim Measures for Quality Management of Commercial Coal 
(IMS  ID 47770) 
3.172.   The representative of Australia  said that Australia was a reliable, long -term supplier of high -
quality coal to China and that China was Australia 's second largest coal export market. Australia had 
played an enduring role in contributing to energy security and industrialisation in China and 
respected China 's right to ensure the use of coal within China met environmental standards. The 
                                                
67 For previous statements follow the thread under IMS ID 428  (under dates raised and references) . 
68 G/TBT/M/76 , para. 3.85; and G/TBT/M/75 , para. 4.94.  
69 For previous statements follow the thread under IMS ID 4 66 (under dates raised and references) . 
70 For previous statements follow the thread under IMS ID 477  (unde r dates raised and references) . G/TBT/M/77  
 
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  quality of Australian coal was amongst the highest in the world. Australia had noted reports of 
increased disruptions to imports of Australian coal at Chine se ports since November 2018, including 
delays of up to 40 days for Australian coal to be unloaded, compared to 20 days prior to November 
2018. He asked China to confirm in writing whether recent disruptions to coal imports were related 
to the Interim Meas ures for Quality Management of Commercial Coal, notified on 18 September 
2014. If the reported disruptions were a result of new measures, he asked  China to provide written 
copies of the measures to Australia and notify them to the TBT Committee or other re levant WTO 
committee. Australia welcomed the opportunity to comment on any new measures and would be 
seeking to ensure that any measures regarding coal quality standards or testing were consistent 
with WTO rules and were non -discriminatory, applying to all  imports as well as domestically produced 
coal. He noted that both China and Australia were signatories to the International Laboratory 
Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) and that under this 
agreement, coal could be tested prior to leaving Australian ports. Australian testing facilities were 
equipped to accurately test against China's coal quality standards and Australian coal was exceeding 
these high standards. Australia encouraged China to accept coal test results by indep endent test 
laboratories in Australia, as other coal importing countries did. Australia looked forward to continuing 
dialogue with China to ensure that legitimate environmental policy objectives could be met through 
WTO-consistent measures, which were not more trade restrictive than necessary.  
3.173.   The representative of China  said that since the entry into force of the Interim Measures for 
Quality Management of Commercial Coal in 2015, both imported coal and domestic coal were treated 
equally. For inspection, bo th Chinese and international methods could be adopted and the 
consistency of inspection method ensured the consistency of results. According to China 's laws and 
regulations, the imported goods were subject to the inspection of China 's Entry -Exit Inspection  and 
Quarantine Bureau. The statutory inspection could not be replaced by third -party inspection. The 
goods in bulk needed to be inspected at port of unloading and statutory inspection in the port of 
entry could not be replaced by pre -shipment inspection.  
3.4.27   India — The Stainless  Steel Products (Quality Control) Order, 2015 , 
G/TBT/N/IND/50  (IMS  ID 48671) 
3.174.   The representative of the European Union  raised concerns on India's Stainless Steel Products 
(Quality Control) Order, 2015 . The full statement is contained in G/TBT/W/635 .  
3.175.   The representative of India provided responses to the concerns raised. The full statement in 
contained in G/TBT/W/623 . 
3.4.28   India — Draft Food Safety and Standards (Alcoholic Beverages St andards) 
Regulations, 2015 , G/TBT/N/IND/51 , G/SPS/N/IND/119  (IMS ID 49472) 
3.176.   The representative of the European Union  reiterate d its concerns re garding th e measure. 
The EU welcome d the publication of the regulation on additives for alcoholic beverages in the Gazette 
in August 2017, although she said that not all their concerns had been taken on board. The regulation 
had been  published in April 201 8. Enforcement of the regulation published in April 2018 would  start 
in April 2019. She said that w hile th e regulation answer ed some of the concerns raised by the EU, 
some issues of concern remain ed. The EU recall ed transparency obligations contained in the TBT 
Agreement , pointing out that  the list of food additives permitted in alcoholic beverages adopted by 
the competent Indian authorities had been  notified to WTO on 22 September 2016 , but only via the 
SPS notifica tion system. India was invited to notify the regulation also to the TBT Committee and to 
allow a reasonable time for comments before entry into force.  
3.177.   Whilst India had taken most comments into account, her delegation requested that the lack 
of stock -exhaus tion clause  be addressed  so as to allow the sale of products already present on the 
Indian market until exhaustion of stocks in order to minimi ze the impact for economic operators.  
Also still of concern was t he presence of some technical specifications (e. g.: maximum alcohol 
content, sugar content) that in the EU's view may not be in line with international standards or with 
international widely accepted practices and could adverse ly impact international trade , prevent ing 
some EU wines, spirits or beers from enter ing the Indian market. Some labelling requirements were 
considered excessive (e.g.: residues of additives in the final product) and could  potentially trigger 
                                                
71 For previous statements follow the thread under IMS ID 486  (under dates raised and references) . 
72 For previous statements follow the thread under IMS ID 494  (under dates raised and references) . G/TBT/M/77  
 
- 30 - 
 
  additional technical controls that might result in unjustified barriers to trade.  Finally, she said that 
the regulation also include d the need to satisfy excessive analytical parameters that would result in 
additional technical controls (residual extracts, higher alcohol, iron …) , which might once again result 
in unjustified barriers to trade.  
3.178.    The representative of Jamaica  noted the implementation of the revised Indian standard for 
alcoholic beverages had come into force on 1 April 2019 and which provided for a specification for 
rum. He said that the Caribbean was widely regarded as the region w here the product distilled from 
sugar cane materials (juice, syrup or molasses) had first come to be known as "rum". The Caribbean 
had a long tradition of rum production from sugar cane -based raw materials. Jamaica applauded the 
efforts of the Indian autho rities to improve several aspects of the standard.  It was noted that the 
standard provided for age statements to reflect the youngest spirit in the blend and that the only 
colouring must be obtained from caramel.  His delegation considered these to be impor tant 
international practices deserving endorsement.  
3.179.    However, Jamaica pointed out that internationally, rum was recognized as the product 
obtained from the fermentation and distillation of sugarcane materials – fresh cane juice, syrup, 
molasses. This under standing was clearly outlined in the Harmonised System agreed by members 
of the World Customs Organisation and in virtually all beverage alcohol standards around the world. 
In this sense the Indian specification which said "rum…may also be prepared from ne utral, rectified, 
distilled spirit of agricultural origin", would appear to be at variance with international practice and 
conventions. Due to cost advantages afforded by non -specific raw materials, the permission granted 
by these provisions may inadverten tly result in an unfair advantage to Indian producers in the 
national market and potentially in international commerce. Internationally the product "rum" was 
widely understood to originate from a sugarcane distillate and to use any other raw material may 
give rise to the perception of consumer deception. Jamaica was encouraged by the steps being taken 
by India and urged the Indian government to re -examine its regulation with a view to enhancing the 
transparency element of the regulation and the authentic sp ecification for the product "rum".  
3.180.   The representative of India provided responses to the concerns raised. The full statement in 
contained in G/TBT/W/620 . 
3.4.29   China — Formula Registration Regulation for Infant and Follow -up Formula, 
G/TBT/N/CHN/1165  (IMS ID 49373)  
3.181.   The representative of the United States  support ed other Members ' previous interventions on 
this issue. The United States remain ed concerned with regard to implementation requirements for 
registration of infant formula. The US looked forward to receiving an update on the measures, as 
had been in dicated by China at the previous TBT Committee meeting.  
3.182.    The representative of Switzerland  supported the previous comments made by other 
Members. While Switzerland shared and supported China 's desire to protect public health, there 
were concerns about the impact these measures might have on trade. A number of issues still 
remained unclear in relation to the registration process of new infant and follow -up formulae, 
particularly circumstances under which inspections were needed to achieve the legitimate obje ctives 
pursued. Establishments in Switzerland operated under mandatory self -controls and official controls 
by the competent Swiss authorities. Inspections by the competent Chinese authorities should be 
limited to cases where significant changes to the prod uction were made. Switzerland welcomed 
China's engagement with Members to avoid unnecessary obstacles to trade and thanked China for 
the bilateral exchanges and looked forward to further cooperation.  
3.183.   The representative of China  provided further information  on the measure. In 2016, the 
Formula Registration Regulation s for Infant and Follow -up Formula Milk Powder had been  issued. In 
2017, the guidelines to implement the regulation (CFDA175) had been  issued : Application 
Documents and Requirements for the Formu la Registration of Infant Formula Milk Powder ; and Site 
Checklist and Criteria for the Formula Registration of Infant Formula Milk Powder. She said that bo th 
domestic and foreign companies were treated equally.  
                                                
73 For previous statements follow the thread under IMS ID 493  (under dates raised and references).  G/TBT/M/77  
 
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  3.4.30   Egypt — Manufacturer Registration System (Dec ree No. 43/2016 and Decree No. 
992/2015) , G/TBT/N/EGY/114 , G/TBT/N/EGY/115  (IMS ID 50574) 
3.184.   The representative of the European Union  noted that the recent Decree no 44/2019 of 15 
January 2019 extended the coverage of the mandatory registration of importers established by two 
ministerial Decrees (No. 991/2015 and 43)  to four new product groups. However, this decree had 
been notified to th e TBT Committee only after its adoption on 14 February 2019, and WTO Members 
had not ha d an opportunity to submit their comments. The EU appreciated the exchange of 
information in the TBT Committee concerning the state -of-play of the registration of EU com panies. 
Nevertheless, EU industry and especially small and medium -sized companies, continued to report 
serious difficulties with regard to the duplication of procedures and, in particular, long delays in the 
registration process. She stated that ceramic se ctor companies were particularly affected. The EU 
requested that all the companies which submitted complete documentation be registered without 
further delay. The EU also requested that Egypt provide a list of EU companies to which registration 
had been re fused. The EU reiterated its invitation to Egypt to suspend or substantially improve the 
registration process and recalled the details provided in the EU's previous statements of the past 
TBT Committees. Finally, the EU invited the Egyptian authorities to inform the Committee on the 
steps taken to facilitate compliance with the registration requirements by companies.  
3.185.   The representative of Brazil  shared concerns expressed by the EU and reported that certain 
Brazilian companies of tableware glass and ceramic articles, cosmetics, and food products had 
reported serious difficulties stemming from long delays in the registration process, in some cases 
extending for almost two years. Brazil said that requirements established by Decree 43/2016 for 
manufacturer regis tration were adding costs and creating unnecessary obstacles to trade and were 
not in line with commitments under the TBT Agreement. Furthermore, significant decreases in 
exports of affected Brazilian goods to Egypt had also been reported. He noted that Br azilian 
authorities had been in continuous contact with Egyptian authorities in Cairo and in Geneva to 
express these concerns, which were preventing bilateral trade from growing and diversifying. This 
situation was particularly worrying given the fact that  the Mercosur -Egypt FTA was already in force 
since September 2017. Brazil requested Egyptian authorities to implement changes to simplify the 
registration requirements established by Decree 43/2016.  
3.186.   The representative of Thailand  reiterated interest in thi s measure and recalled that last year 
Thailand joined other Members to encourage Egypt to facilitate the registration process in a 
transparent and timely manner in order to avoid disruption. However, several Thai companies were 
currently still awaiting fin al approval, despite submitting applications and documents to the General 
Organization for Export and Import Control (GOEIC)  in 2016. Despite communication with competent 
authorities, no responses had been provided in this regard. Thailand appreciated good  cooperation 
and bilateral meeting in the past with Egypt and welcomed any further progress in this matter.  
3.187.   The representative of Egypt  appreciated requests from a few delegations for bilateral 
meetings on this matter; she believed that useful and fruitful  bilateral exchanges among Members 
was the only way to clear misunderstandings and reach resolutions. Egypt had asserted in a number 
of previous Committee meetings that Decree 43 had been  adopted as a tool for market surveillance 
solely, and that no restri ction on trade ha d resulted from it. She said this argument was strongly 
supported by the fact that Egypt 's imports in 2017 had witnessed an increase of almost 14% 
compared to the previous year. Similarly, the period January -October 2018 had witnessed more  
than 19% increase in trade to reach 57.7 billion USD compared to 48.5 billion USD in the same 
period of 2017.  As highlighted during previous meetings, Egypt reiterated that the sole purpose of 
Decree 43 was monitoring the Egyptian market and protecting Eg yptian consumers from 
counterfeited products, and that full consideration had been given to ensure Decree 43 was not more 
trade restrictive than necessary. In addition, Egypt said full consideration had been given to ensuring 
the simplicity of the required  documentation and procedures so that no extra burden would be 
imposed on trading partners, and that the confidentiality of data provided by companies was 
preserved. Egypt noted that no application from a company had been rejected to date. She noted 
all th e comments and concerns raised and urged Members to convey problems faced by their 
companies with registration, so that her delegation could investigate the means of addressing these 
problems.  
                                                
74 For previous statements follow the thread under IMS ID 505  (under dates raised and references) . G/TBT/M/77  
 
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  3.4.31   Ireland  — Public Health (Alcohol) Bill 2015, G/TBT/N/IRL/2  (IMS ID 51675) 
3.188.   The representative of Argentina  reiterated his delegation's concerns regarding the Republic 
of Ireland's Public Health (Alcohol) Bill, adopted in 2018, which established additional labelling and 
marketing specifications and in particular the inclusion on labels of warnings concerning th e direct 
connection between alcohol and fatal cancer. Argentina referred to the comments and objections 
made at previous meetings, in which Argentina had highlighted the importance of adopting 
appropriate measures to protect human health without creating a n unnecessary barrier to 
international trade.76 Bearing in mind that the Public Health Bill had been promulgated in October 
2018, Argentina requested the European Union to indicate what evaluations had been carried out 
regarding this measure and, in particu lar, whether Ireland had made the corresponding notifications 
to the Commission through the Technical Regulations Information System (TRIS). Ireland was also 
requested to provide a tentative schedule for the implementation of this Bill and the EU Commissio n 
was requested to notify this measure and ensure its consistency with all applicable WTO obligations.  
3.189.   The representative of the United States  supported Ireland 's objective of managing the public 
health challenges of excessive alcohol consumption. At the N ovember 2018 TBT Committee meeting 
the United States had repeated its request for Ireland to notify the amendments made to its Public 
Health (Alcohol) Bill 2015. At that meeting Ireland had indicated that, due to public health concerns, 
it had been forced to enact the bill as soon as possible. Ireland further indicated in November that 
the labelling provisions would require secondary legislation that these would need to be notified 
(first) to the European Commission and that Ireland would then notify these provisions to the WTO 
TBT Committee. Also, Ireland had confirmed at the November 2018 meeting that the secondary 
legislation and the primary law would not become operational for three years. The United States 
asked if Ireland could clarify its regulatory p rocess for the forthcoming secondary legislation, and 
provide an expected timeline for notification to the TBT Committee . As the US had previously noted, 
there was concern about the impact of labelling provisions on US producers, including on their ability  
to reallocate products in the EU 's internal market. Would Ireland continue to accept product that 
had already been labelled for other EU markets?  Alternatively, was Ireland proposing that producers 
would have to re -label any product that first entered ano ther EU member State that they 
subsequently wished to send to Ireland for sale?  
3.190.   The representative of New Zealand  supported Ireland 's right to introduce new regulations to 
address legitimate public health objectives and noted the EU response that the prop osed labelling 
and health warning provisions of Ireland 's Public Health Alcohol bill 2015 had not been implemented 
by Ireland on the passing of the bill domestically on 17 September 2018, and that, at the date of 
the November 2018 Committee meeting, these proposed measures for labelling and health warnings 
on alcohol were still to be submitted by Ireland to the European Commission for consideration before 
implementation. New Zealand recalled that the EU had advised the Committee in November 2018 
that once t hese labelling and health warning measures were submitted to the European Commission 
by Ireland, the EU would notify these measures to the Committee. New Zealand requested an update 
on the status of proposed health and warning label measures for alcohol to  be sold in Ireland. New 
Zealand also requested that the Committee be advised of the expected date that the proposed health 
and warning label measures for alcohol to be sold in Ireland would be notified to WTO Members, and 
when the content of the proposed measures would be available for review.  
3.191.   The representative of Mexico  thank ed the EU for the bilateral discussions and reiterate d its 
request to Ireland and the EU to notify as soon as possible the secondary legislation that the Ministry 
of Health was plann ing for this law and allow for a time -frame for this to be reviewed.  
3.192.   The representative of Australia  recogni zed the right of governments to take measures 
necessary to protect public health and appreciated the Republic of Ireland's   efforts  to address a 
legitimate public health concern. It was noted that Australia was currently reviewing responses 
provided by the EU to Australia 's comments. Noting that the implementation time frames for 23 of 
31 sections the Public Health (Alcohol) Act 2018,  Australia sought clarification on the details and 
implementation of the remaining eight sections, in particular Section 12 on Labelling. Australia also 
sought clarification on the process with regards to clearance at EU level. Australia asked for advice 
on the expected timing for implementation of the new requirements and welcomed the information 
that policy implementation would include a transition period to enable businesses time to prepare 
                                                
75 For previous statements follow the thread under IMS ID 516 (under dates raised and references) . 
76 G/TBT/M/76 , para. 3.133.  G/TBT/M/77  
 
- 33 - 
 
  for the new requirements. Australia also welcomed clarification as to whether alcohol importers and 
exporters had participated in consultations on the impact of the requirements and sought further 
clarification as to the evidence on which the draft legislation and labelling requirements had been 
based, and how the prop osed measures would contribute to public health objectives. Noting that 
significant amendments had been made to the Act since it had been notified to the WTO, Australia 
encouraged Ireland to re -notify the new Act through a TBT notification procedure, to al low trading 
partners to comment on the revised proposal.  
3.193.   The representative of Chile supported the interventions made by other delegations.  
3.194.   The representative of the European Union  thanked delegations for their statements on the 
Irish "Public Health (Alc ohol) Bill 2015" notified to the TBT Committee on 9 June 2016 under 
G/TBT/N/IRL/2 . As had been mentioned at the previous TBT Committee meeting77, because of the 
severe public health implications of this issue , the Government of Ireland had been obliged to enact 
the primary legislation at the earliest possible date. The Bill had  been signed into law on 17 October 
2018 and a copy was available online.78 The labelling provisions of Health Bill required secondary 
legislation; these implementing regulations would have to be notified to the European Commission 
under Regulation (EU) 116 9/2011 and would also be notified to the TBT Committee. It was noted 
that the three -year lead -in time before the provision became operational would not commence until 
the notification processes at EU and WTO level had been completed to allow businesses the  full three 
years to prepare for and to make the necessary changes to comply with the new measures. With 
respect to comments received from WTO Members under the WTO TBT notification procedure, these 
had been examined and replies had been sent to relevant M embers the previous week.  
3.4.32   Russian Federation, Kazakhstan, Kyrgyz Republic — Pharmaceutical products - 
Resolution 1314 of the Government of the Russian Federation on determining compliance 
of medicinal products' manufacturers with the requirements of Good M anufacturing 
Practice (non -notified); draft decisions of the Board of the Eurasian Economic Union,  
G/TBT/N/RUS/54 , G/TBT/N/RUS/58 , G/TBT/N/RUS/63  (IMS  ID 52179) 
3.195.   The representative of the European Union  raised concerns regarding measures adopted by 
the Russian Federation introducing certification requirements for medicinal products. The full 
statement is contained in G/TBT/W/636 . 
3.196.   The representative of Ukraine  echoed the concerns raised by the EU and register ed her 
delegation's  interest in t he issue.  
3.197.   The representative of the Russi an Federation  informed the Committee that the System of 
Good Manufacturing Practice for pharmaceutical products was fully based on international standards 
and recommendations in this sphere. On the concern regarding lack of inspection capacities in the 
Russian Federation, also raised previously, he reported that during the period from 2016 to 2018 
inspection capacities had increased four -fold. 85% of inspectors were responsible for conducting 
inspections abroad and these regularly participated in experience -sharing activities with their foreign 
counterparts and advanced training courses including those approved by the WHO. For the period 
2016-2018, the Ministry of Industry and Trade of the Russian Federation had received 2,110 
applications for GMP certificat ion from foreign entities, 1,452 inspections were conducted, 1,393 
inspection reports were submitted to the Ministry of Industry and Trade, 1,007 foreign entities were 
certified and 410 applications were declined.  
3.198.   He also noted that in accordance with para graph 16 of the Rules of Good Manufacturing 
Practice, if the period of validity of the issued certificate or the location of manufacturer or scope of 
pharmaceutical products manufactured on that production site were changed, the authorized body 
had the opp ortunity to decide whether to issue the certificate without re -inspection. Recently passed 
legislation, specifically the amendments to the Federal Law "On the circulation of medicines" that 
had entered into force on 15 June 2018, allowed parallel conductio n of GMP inspections and 
registration of pharmaceutical products. New rules significantly reduced the period for release of 
                                                
77 G/TBT/M/76 , para. 3.139.  
78 http://www.irishstatutebook.ie/eli/2018/act/24/enacted/en/html . 
79 For previous statements follow the thread under IMS ID 521  (under dates raised and references) . G/TBT/M/77  
 
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  pharmaceutical products. Russia remained open to consideration of all comments and questions on 
the issue and to engage in construct ive dialogue with WTO Members.  
3.4.33   China — Cybersecurity Law (IMS ID 52680) 
The representative of Japan  reiterated previously raised concerns81 and requested China to 
provide information on the situation of "Security Assessment Measures for Cross -Border Transfer  of 
Personal Information and Important Data", which was subject to public comment in April 2017 and 
was scheduled to enter into force from the end of last year.  
3.200.   The representative of the European Union  reiterated previously raised concerns.82 The full 
statement is contained in G/TBT/W/637 . 
3.201.   The representative of the Republic of Korea  supported the concerns raised by other Members 
and reiterated previously raised concerns, particularly regarding the need to clarify the meaning of 
"high level of safety risks ". It was also noted that since the implementation of the Cyber Security 
Law on 1 June 2017, Korean companies were having difficulties complying with the law, as the 
specific content such as the relevant decree, rule, and standard had not yet been announced. As a 
result, China was requested to provide a timeline of the announceme nt and enforcement, and 
further, to publish a security assessment guideline, containing detailed examples and case studies 
of "data with high level of safety risks ". In addition, China was urged to provide a grace period of at 
least six months after the an nouncement of the final document since exporting companies needed 
reasonable time to comply with the regulation.  
3.202.   The representative of the United States  referred the Committee back to its previous 
statement delivered in November 2018.83 
3.203.   The representative of Australia  supported the concerns raised by other Members and 
reiterated previously raised concerns regarding China 's Cyber Security Law and related laws 
including the recent draft Provisions on Internet Security Supervision and Inspection.84  
3.204.   The represe ntative of China  said the Cyber Security Law was a fundamental and framework 
law in the field of China’s cyber security, which ha d marked a milestone in the history of national 
cyber security cause. The release and implementation of the Cyber security law  was aimed not only 
at protect ing the interest of those using  cyber space and effectively safeguard national sovereignty 
and security in cyber space by legal means, but also to promote the application of information 
technology and put into  play the huge potential of the internet.  Opening up w ould remain the basic 
policy of China and w ould continue to become even more open . It was a principle that China would  
continue to open to the outside world and maintain cyber security in an open environment. The 
purpose of the law was to safeguard national sovereignty in cyber space, national security and public 
interest, and protect the rights and interests of citizens, legal persons and other organizations in 
China. It was by no  means meant to restrict market access  of foreign enterprises, technologies and 
products in China, nor would it  restrain the orderly, free  flow of the data in accordance with the law.  
3.4.34   European Union — Organic production and labelling - Maté (erva -mate) (IMS  ID 
52485) 
3.205.   The representative of Brazil recalled  concerns raised at previous meetings.86 Brazil welcomed 
that EU Regulation 2018/848 now included "erva mate" in its list of organic products. Brazil, 
however, was still concerned with the long waiting period until the date this measure would ente r 
into effect on 1 January 2021. During this period Brazilian "erva mate" producers would not be able 
to have access EU organic labelling, as provided under this regulation. He recalled that in previous 
meetings Brazil had argued that not including "erva -mate" in the organic product list without any 
technical or scientific justification was discriminatory and more trade -restrictive than necessary, and 
                                                
80 For previous statements follow the thread under IMS ID 526  (under dates raised and references) . 
81 G/TBT/M/76 , para . 3.153; G/TBT/M/75 , para. 4.172 and G/TBT/M/74 , para. 2.196.  
82 G/TBT/M/76 , para. 3.155  and the full statement contained in  G/TBT/W/509 .  
83 G/TBT/M/76 , para. 3.156 . 
84 G/TBT/M/76 , para . 3.157 and G/TBT/M/75 , para. 4.175.  
85 For previous statements follow the thread under IMS ID 524  (under dates raised and references) . 
86 G/TBT/M/76 , para. 3.159; and G/TBT/M/75 , para. 4.177.  G/TBT/M/77  
 
- 35 - 
 
  thus inconsistent with Articles 2.1 and 2.2 of the TBT Agreement. The approval of EU Regulation 
2018/848 wi thout any transitional measures for allowing "erva -mate" to enjoy organic labelling as 
soon as possible  - rather than waiting until January 2021  - seemed to indicate, in Brazil's view, that 
the EU had not take n into consideration its early arguments about possible inconsistencies of this 
EU Regulation with certain TBT Agreement provisions.  
3.206.   The representative of the European Union  repeated the responses provided at the previous 
TBT Committee meeting.87  
3.4.35   European Union — Regulation (EC) No 1107/2009 - non-renewal of approval of 
the active substance picoxystrobin G/TBT/N/EU/437  (IMS ID 53588)  
3.207.   The representative of Brazil  raised concerns regarding the European Union's regulation on 
the non -renewal of approval of the active substance picoxystrobin. The full statement is contained 
in G/TBT/W/624 . 
3.208.   The representative of Canada  said that picoxystrobin was a key active substance used for 
grain and oilseed pr oduction in Canada. A growing number of active substances were not being 
renewed in the European Union due to incomplete or insufficient information to complete a risk 
assessment and exclude health and environmental concerns. However, given that picoxystro bin was 
approved in 65 countries, Canada encouraged the EU to indicate what information was needed to 
complete and conclude its risk assessment.  
3.209.   The representative of Panama  supported Canada's intervention and reiterated his 
delegation's previous concern t hat this EU measure constituted an unnecessary barrier to trade. As 
a tropical country, Panama depended on the use of these types of active substances in order to 
protect itself from fungi, from insects and other items that were not present in the EU.  
3.210.   The representative of Paraguay  reiterated her delegation's previous concern with  the EU 
decision not to renew the approval of picoxystrobin because the EU had not based this decision on 
scientific criteria, ignored international consensus, and the opinion of specialized agencies on non -
toxicity in the use of these substances. This decision, as well as the new MRLs for this substance 
notified to the SPS Committee , would have a negative impact on Paraguayan exporters by restricting 
trade unnecessarily.  She no ted that at the last SPS Committee meeting, 15 Members had also 
expressed concerned with these new MRLs  established by the EU. In her delegation's view in this 
other body, showed that these EU measures could adversely affect several WTO Members. Despite 
these many expressions of concern, the EU had nonetheless decided to approve the amendment of 
the MRLs for this substance in January 2019, as notified in G/SPS/N/EU/264/Add.1 . 
3.211.   The representative of Colombia  expressed her delegation's interest in following these topics 
and discussions, as they progress both at the TBT and SPS Committees.  
3.212.   The representative of the European Union  reiterated responses provided at previous 
TBT Committee meetings.89 He provided a further update on the draft measure lowering the MRLs 
for picoxystrobin to the limit of quantification (LOQ), which w as prepared and presented to the 
Standing Committee on Plants, Animals, Food and Feed. The EU had notified third countries of the 
draft Regulation via the SPS procedure. Comments received from non -EU countries and stakeholders 
were available to the Standin g Committee, where a summary of the key points raised had been  
presented. The Standing Committee had given a favourable opinion on the draft. The European 
Commission had formally adopted the revised MRLs in January 2019. The revised MRLs were set to 
apply as from 13 August 2019. The EU also clarified that import  tolerance requests however 
remained possible and would be assessed on a case -by-case basis by EFSA. Such requests would 
have to be supported by substantial new data addressing the conc erns. 
                                                
87 G/TBT/M/76 , para. 3.160.  
88 For previous statement s follow the thread under IMS ID 535  (under dates raised and references) . 
89 G/TBT/M/76 , para. 3.176 and G/TBT/M/75 , para. 4.188 . 
 G/TBT/M/77  
 
- 36 - 
 
  3.4.36   China — Certification requirements for processed foods , G/TBT/N /CHN/1209  (IMS 
ID 54790) 
3.213.   The representative of the United States  reiterated concerns raised in the previous TBT 
Committee meeting.91 
3.214.   The representative of the Republic of Korea  reiterated concerns raised at the previous TBT 
Committee meeting92 and requested sufficient scientific evidence for this measure. Korea noted that 
this measure was inconsistent with Codex guidelines and principles. This requirement, which was 
not based on scientific risk assessment was more trade restrictive than necessary. Given the sh ort 
transitional period until its entry into force in October 2019, China was asked to share the revised 
draft measures reflecting WTO Members' comments in a timely manner.   
3.215.   The representative of Guatemala  thanked China for its willingness to change the da te of 
entry into force of the measure to October 2019, giving the industry the necessary time to adapt to 
the new measures. However, she sought confirmation that the certification requirement had been 
eliminated. She also requested more clarity about the n ew structure in the customs office, 
corresponding to the changes to be made in the regulations. She asked whether China would notify 
the new structure and processes.  
3.216.   The representative of Mexico  said that her delegation followed with great interest the 
developments regarding China's certificates. She thanked China for the bilateral meetings, which 
had taken place over the previous few days and looked forward to receiving responses.  
3.217.   The representative of China  thanked delegations for their comments, which we re very useful 
for understanding trade partners ' thoughts and assess effects of the proposed regulation. As 
explained on various occasions, the objective of the regulation was not to restrict trade, but to 
ensure safety and improve traceability through str engthening supervision responsibilities of 
exporting parties ' authorities. China was still considering the many comments received from 
Members following the notification of the draft. While a final decision had not been reached, he 
reassured Members that t he measure would not affect existing trade after October, even when 
Members could not provide certificates for processed food, until a mutually agreed solution was 
found.  
3.4.37   Viet Nam — Decree on the regulation on conditions for automobiles manufacturing, 
assembling importing and automotive warranty & maintenance services (IMS ID 54993) 
3.218.   The representative of Thailand  reiterated previously raised concerns regarding the 
requirements contained in Decree 116.94 The lot -by-lot testing requirements for imported vehicle s 
would be especially onerous for Thailand's automobile exporters adding additional testing costs and 
serious delays in imports. Viet Nam  had stated at the previous meeting that automobile enterprises 
had been consulted and that imports had since recovered . However, testing for imported cars still 
had to be conducted lot -by-lot which differed from Vietnamese domestic cars. There was evidence 
that Thailand 's car export rate to Viet Nam  had decreased by 10%. Moreover, it took two months 
more to complete the i mportation process into Viet Nam  compared with prior to  entry into force of 
Decree 116. In order to  remove this technical barrier to trade, Thailand requested that Viet Nam  
revise the lot -by-lot testing requirements , to test only once, applying the results  to all cars covered 
by the same production series , and to accept the VTA certificate conducted by exporting countries 
without additional conditions. Thailand was monitoring Viet Nam's automobile regulations closely 
and was aware that Viet Nam was going to  adopt a new circular on the technical safety, quality 
inspection and environmental protection in manufacturing and assembling motor vehicles including 
the auto parts; which would enter into force in  April 2019. He asked that Viet Nam notify the referred 
draft circular, circular No.03 and any implementing circulars for Decree 116 to the Committee so 
                                                
90 For previous statements follow the thread under IMS ID 547 (under dates raised and references).  
91 G/TBT/M/76 , para. 3.185.  
92 G/TBT/M/76 , para. 3.182 . 
93 For previous statements follow the thread under IMS ID 54 9 (under dates raised and references).  
94 G/TBT/M/76 , para. 3.203 . 
 G/TBT/M/77  
 
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  that Members could comment  and allow time for industry to become acquainted with the new 
requirements.  
3.219.   The representative of the European Union  reiterated conce rns raised at the previous TBT 
Committee meeting.95 In addition she raised concerns with a new circular within the framework of 
Decree 116  where  Viet Nam  was also considering no longer allow ing for the recognition of UN 
certificates  for car parts  and would require all imports to undergo local testing. This was clearly 
against the EU -Viet Nam  Free Trade Agreement . Viet Nam  should  recogni ze EU parts and equipment 
complying with UN regulations without further testing and certification. The same should apply to 
passenger cars.  
3.220.   The representative of the United States  reiterated the concerns raised in the previous TBT 
Committee meeting.96 
3.221.   The representative of Japan  shared the concerns raised by other Members regarding Decree 
116. According to the Decree, imported automobiles were required to have a copy of vehicle type 
approval issued by overseas authorized agencies . Domestic automobiles were only required to have 
vehicle type approval issued by Vietnamese authorities . Imported automobiles were subject to 
inspectio ns in each shipment. Japan requested that Viet  Nam treat imported automobiles and 
domestic automobiles in an equitable manner.  
3.222.   The representative of Viet Nam  informed the Committee that under the Law on Investment 
enacted in 2014, automobiles manufacturing , assembling, import and related services such as 
guarantee and maintenance are business and investment operations and must meet prerequisite 
conditions for the sector. Automobile products required strict inspections to ensure they met quality 
standards as  they posed a high risk to people's safety and the environment. Government Decree 
116 2017 ensured technical safety and environment protection while upholding customers rights on 
the basis of the fair competition principle. According to Vietnamese  customs statistics , automobiles 
from different originating markets ha d been imported into Viet Nam. Feedback from importer 
representatives had been that the process took time to get acquainted with and adjust to 
successfully, including the VTA and lot -by-lot inspections. Examination of complaints by importers 
concluded that compliance was not too complicated or costly. The lot -by-lot testing on imported 
automobiles had been carried out in accordance with Circular No. 3 2018, guiding implementation 
of Decre e 116 2017. It was one of the quality control measures applied in accordance with Viet 
Nam's Law on Goods Quality in Compliance with International Standards and Practice. This was the 
most appropriate when product manufacturing process could not  be control led. The testing fee was 
based on actual costs of services. The fee construction methodology was popular in the ASEAN region 
and the fee much lower than in developed countries, due to lower labour costs. Testing times mostly 
depended on how well importers or manufacturers made the sample ready for testing in accordance 
with clear guidance.  
3.4.38   Viet Nam — Cybersecurity Measures (IMS ID 54497) 
3.223.   The representative of Japan  reiterated previously raised concerns regarding Viet Nam 's 
Cybersecurity Law, and noted that a t the last meeting, Japan had requested that Viet Nam notify 
the Decree to the TBT Committee and to consider comments from Members. The Decree ha d not yet 
been notified even though the draft Decree had indicated the date of entry into force on 1 January 
2019. Japan therefore requested Viet Nam to provide updated information on the status of entry 
into force of both the Cybersecurity Law and its Decree as it would be regrettable if the Decree came 
into force without TBT notification. Japan also requested Vie t Nam to provide the details of the term 
"cybersecurity condition " and the procedures in legal forms. Moreover, Japan remained concerned 
with the entities that would be obliged to comply with the requirement to store data locally and to 
open up a branch or  a representative office in Viet Nam as stipulated in articles 24 and 25 of the 
Decree.  
3.224.   The representative of the United States98 stated that her delegation was disappointed that 
Viet Nam had failed to formally notify the Law to the WTO while still in draf t form. The US requested 
                                                
95 G/TBT/M/76 , para. 3.205 . 
96 G/TBT/M/76 , para. 3.206.  
97 For previous statements follow the thread under IMS ID 54 4 (under dates raised and references).  
98 G/TBT/M/76 , para . 3.211.  G/TBT/M/77  
 
- 38 - 
 
  Viet Nam to notify the Law and the draft implementing measures that were published on 2 November 
2018 and to allow all interested parties to provide input.  Moreover, Viet Nam was asked to consider 
using a risk -based approach to cyb ersecurity that drew from industry best practices, widely accepted 
definitions, and international standards, including the Common Criteria Recognition Arrangement 
(CCRA) certification process when finalizing the draft implementing measures for the Law.  
3.225.   The representative of the European Union  supported the concerns raised by other Members 
and recalled  previously raised concerns regarding  the potential economic impact o f that  legislation 
and the compatibility with Viet  Nam's commitments under the WTO.99 Her delegation welcomed 
public consultation s on the Draft Implementing Decree on Cybersecurity that ha d allowed the 
European Commission and the European External Action Service to provide to the Vietnamese 
authorities comments on the draft legislation. According to recent information, the implementing 
decree, which set  out further details for some articles of the  Cyber Security law, had not yet been 
adopted  and therefore her delegation requested that Viet N am notify  the draft decree to the TBT 
Committee for general transparency purposes and in accordance with Article 2.9 of the TBT 
Agreement. This notificati on would provide to WTO Members the opportunity to analyse the draft 
decree in depth and to provide comments within a reasonable time limit.  
3.226.   The representative of Canada  also supported the concerns raised by other Members , noting 
the importance of WTO noti fications as well as the use of international standards and conformity 
assessment schemes. Canada noted that common information technology products entering Viet 
Nam were already subject to in -country testing even when international standards ha d been met.  
3.227.   The representative of Australia  reiterated previously raised concerns100 and noted that this 
measure could affect Viet Nam 's reputation as an open economy and impact its ability to benefit 
from the digital economy and Industry 4.0. Australia understood that  Viet Nam was currently 
preparing a second draft of the decree implementing the new law and requested Viet Nam to provide 
a period for public consultation on the second draft.  
3.228.   The representative of Viet Nam  responded that the Cyber Security Law had been  adopted 
by the national assembly on 12 June 2018 to ensure that activity in cyber space would  not harm 
national security, social order and safety, legitimate rights of organizations and individuals. Viet Nam 
clarified that the law would provide a full and s trict legal framework for authorities to effectively 
protect national security and at the same time, secure a safe and secure cyber space for the public, 
creating favourable conditions for domestic and foreign IT, telecommunications and internet 
enterprise s to do business in Viet Nam. The representative of Viet Nam noted that Art. 10 of the 
Cybersecurity Law set out conditions applied to national security, critical information systems and 
stated that information systems that belonged to the state agency in the area of critical national 
security and of confidential nature. She explained further that that article did not apply to systems 
that were not national security critical information systems, including information systems of 
domestic private sector and o f enterprises from other countries investing in Viet Nam. In order for 
the Decree to guide implementation of the cyber security law, Viet Nam had already published the 
draft to enable all individual, organization and domestic and foreign enterprises to ass ess and give 
comments. Finally, Viet Nam had taken into consideration all the comments and had worked with 
foreign representative organizations and enterprises for continued improvement of the draft. The 
draft decree was expected to be finalized and submit ted to the government at the end of March 
2019.  
                                                
99 G/TBT/M/76 , para. 3.213.  
100 G/TBT/M/76 , para. 3.212.  
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  3.4.39   China — Catalogue of Solid Wastes Forbidden to Import into China, 
G/TBT/N/CHN/1211 , G/TBT/N/CHN/1224 , G/TBT/N/CHN/1225 , G/TBT/N/CHN/1226 , 
G/TBT/N/CHN/1227 , G/TBT/N/CHN/1228 , G/TBT/N/CHN/1229 , G/TBT/N/CHN/1230 , 
G/TBT/N/CHN/1231 , G/TBT/N/CHN/1232 , G/TBT/N/CHN/1233 , G/TBT/N/CHN/1234  (IMD ID 
545101) 
3.229.   The representative of Australia  reiterated previously raised concerns102 and requested China 
to reconsider the measures, and to facilitate global environmental outcomes by allowing for 
commercially meaningful trade in quality  recyclable inputs.  
3.230.   The representative of the United States  reiterated previously raised concerns regarding 
China's import ban.103 The full statement is contained in G/TBT/W/610 . 
3.231.   The representative of New Zealand  reiterated previously raised concerns regarding the 
inclusion of vanadium slag in China 's catalogue of banned imports under that measure104 and 
supported the concerns raised by other Members on the short comment timeframe and 
implementation period for the measure.  
3.232.   The representative of Canada  supported the concerns raised by other Members and 
reiterated previously raised concerns regarding China 's restrictions on solid waste.105 Canada 
encouraged China to consider other mechanisms to address the very specific problem of 
contaminated materials while ensuring that mutually beneficial trade could  continue in a predictable 
manner.  
3.233.   The representative of China  responded to concerns raised.106 The full statement is contained 
in G/TBT/W/618 . 
3.4.40   India — Amended regulation on toy imports, G/TBT/N/IND/68  (IMS ID 546107) 
3.234.   The representative of the United States  reiterated previously raised concerns.108 The US 
understood that India may be replacing the existing measure with a new regulation that would apply 
to all toy producers, both domestic and foreign. The US would expect a revised measure to apply 
equally to both foreign and domestic producers by req uiring compliance with the same testing 
requirements. If India did proceed with this replacement, the US requested that India notify any 
new measures while still in draft form and ensure adequate time and opportunity for interested 
parties to review the dr aft, submit comments, and have those comments taken into account prior 
to finalizing the measure.  
3.235.   The representative of the European Union  supported the comments made by the United 
States.  The EU reiterated  concerns regarding the obligation for toys import ed into India to be tested 
by a test laboratory accredited by NABL.  He explained t his was costly and time -consuming, especially 
for producers in exporting countries who were, as a result, obliged to duplicate testing with very 
limited or no added value in terms of safety.  This third -party testing obligation replace d the earlier 
requirement according to which imported toys had to conform to international standards (such as 
ISO 8124) and testing had to be done by laboratories accredited under ILAC MRA.  The EU  continue d 
to urge India to consider allowing conformance to the relevant international standards as an 
alternative to the BIS standards.  
3.236.   The EU also remained concerned with the implementation of the amended regulation. He 
reported difficulties and delays faced by international laboratories in getting accredited by NABL led 
to a situation in which the amended regulation corresponded to a de facto in -country testing 
requirement. The EU was aware that applications from foreign laboratories from outside India had 
                                                
101 For previous statements follow the thread under IMS ID 545  (under dates raised and references).  
102 G/TBT/M/76 , para. 3.191.  
103 G/TBT/M/76 , para. 3.193 and the full statement contained in G/TBT/W/574 . 
104 G/TBT/M/76 , para. 3.192; G/TBT/M/75 , para. 4.193; and G/TBT/M/74 , paras. 2.236 -2.237.  
105 G/TBT/M/76 , para. 3.196.  
106 G/TBT/M/76 , para. 3.197  and full statement contained in G/TBT/W/579 .  
107 For previous statements follow the thread under IMS ID 54 6 (under dates raised and references).  
108 G/TBT/M/76 , para. 3.200 and G/TBT/M/75 , paras. 4.205 -4.206.  
 G/TBT/M/77  
 
- 40 - 
 
  been received by NABL but there was no certainty as to whether and when a final decision would be 
taken. In this context, the EU requested India to clarify the status of these applications and whether 
ILAC accredited laboratories situated anywhere in t he world could receive NABL accreditation.  
3.237.   The representative of India repeated responses provided in previous TBT Committee 
meetings.109 On the question from the US on any new regulation, he said he would refer this back 
to capital for consideration.  
3.4.41   Europe an Union — Application of Regulation No. 1169/2011 and Regulation (EC) 
No 1924/2006 as regards the labelling of food products, in not prohibiting or examining 
the use of "palm oil free" labels (IMS ID 555110) 
3.238.   The representative of Indonesia  reiterated her de legation 's concerns on the use of "Palm Oil 
Free" labelling by several food -producing companies in the EU. Food products with palm oil free 
labelling had also been exported to other countries including Indonesia. This was of great concern 
to Indonesia as t he major CPO producer with exports to several countries including the EU.  
3.239.   "Palm Oil Free" labelling led to consumer confusion and misunderstanding on the impact of 
food products containing palm oil. Allowing food exporters to apply this labelling in the a bsence of 
scientific evidence created unfair and unnecessary barriers to trade. Indonesia encouraged the EU 
to be consistent with EU Regulation 1169 Chapter V Article 36 point 2, which stated that voluntary 
labelling should  not mislead and be ambiguous for  consumer s and where necessary should  be 
provided with scientific evidence. The EU did not allow food producers to educate consumers on 
carotenes contained in palm oil due to the fact of the insufficient scientific evidence. This was 
contrary to the curren t situation where EU allowed food producers to use "Palm Oil Free" labelling 
without scientific justification. She emphasized the International Codex standards related to general 
food labelling (General Standard for the Labeling Of Prepackaged Foods CXS 1 -1985), especially 
regarding the basic principles that labelling is not misleading and not related to other products that 
confuse consumers.  
3.240.   She urged the EU to apply the principle of non -discrimination on the treatment given to palm 
oil compared to other vegetable oils (sunflower, soybean, rapeseed oil) and the importance of 
providing scientific evidence related to the impact of palm oil in food products on human health 
compared to other vegetable oils. So as to ensure consistency with the Article 2.1 of t he TBT 
Agreement on non -discrimination and Articles 3.4 and 3.5 on measures by local governments and 
NGOs, Indonesia urged the EU to take necessary action to ensure that their NGOs and local 
governments applied measures consistent with the TBT Agreement.  
3.241.   The representative of Colombia  reiterated concerns with the EU's regulations about the use 
of "Palm Oil Free" labelling. The full statement is contained in G/TBT/W/599 . 
3.242.   The representative of Costa Rica  reiterated previously raised concerns. Allowing for this 
additional labelling constituted a failure to comply with the principles  and legitimate objectives of 
the TBT Agreement.  
3.243.   The representative of Ecuador  supported the concerns raised by Colombia and Indonesia on 
the practice of labelling food products "Palm Oil Free", thus generating a negative campaign against 
this specific pro duct, without any technical or scientific basis. This label was misleading as it gave 
consumers the impression that products with this label had nutritional or environmental properties 
that similar products did not. From a nutritional perspective, this lab el represented a negative and 
unfounded generalization implying that palm oil was somehow dangerous to one's health or 
nutritionally inferior to other similar vegetable oils. There was no scientific basis for such an 
implication and moreover, it was not in cluded in the Annex to Regulation (EC) No. 1924/2006 of the 
European Parliament and of the Council on nutrition and health claims made on food, list ing 
permitted nutrition claims.  
3.244.   From an environmental perspective, the label implied that palm oil per se wa s less 
environmentally friendly or sustainable than other similar vegetable oils, without considering the 
                                                
109 G/TBT/M/76 , para. 3.202 and G/TBT/M/75 , para s. 4.209 -4.210.  
110 For previous statements follow the thread under IMS ID 555  (under dates raised and references).  G/TBT/M/77  
 
- 41 - 
 
  specific conditions of African palm producing countries such as Ecuador, where palm oil was produced 
in a responsible and sustainable manner. Ecuador joined others in requesting that the EU improve 
how it regulated this type of negative labelling under its existing legislation. Anti -competitive private 
practices such as this were harmful to the palm oil industry, not only to exporters but also to 
Europe an food producers who used this oil as an input, as well as European consumers who were 
being targeted by these marketing strategies.  
3.245.   The representative  of Guatemala  said that as a palm oil producer, Guatemala supported  the 
concerns raised by other delegations. While this measure did not limit the use of palm oil, it did 
discourage its use, thereby discriminating against palm oil as opposed to other vegetable oils and,  
in particular, oils produced by the EU, putting palm  oil at a disadvantage. In 2017, palm oil was 
Guatemala's sixth main export. These new measures would have a major impact on bilateral trade, 
as the EU was one of Guatemala's main trading partners in this product. The palm oil agro -industry 
in Guatemala ac counted for 28,000 direct jobs, particularly in rural areas, and 85,000 families within 
the country benefited from its production.  
3.246.   The production sector was making the necessary efforts to generate sustainable production, 
implementing policies at the priva te sector level and estimating greenhouse gas (GHGs) emissions 
in palm oil production, thus demonstrating the commitment to these issues. Furthermore, Guatemala 
considered it necessary to differentiate between palm oil production and production conditions.  
Condemning the global production of palm oil and along with it the many families whose daily 
livelihood depended on this crop was simply not an option. Guatemala reiterated its commitment to 
meeting the UN SDGs, and support for sustainable palm oil certif ication with a view to meeting the 
Millennium Goals . 
3.247.   The decision made by the Trilogue (European Commission, European Parliament and Council 
of Europe) and its final approval in 2019 was worrying, especially as some producing countries had 
requested a hear ing with the presidents of these three bodies and had not yet received a positive 
reply in writing to have a space for dialogue. Guatemala was concerned by the negative impact of 
these measures and the opacity of the process.  Guatemala would continue to pa rticipate actively in 
the TBT Committee and in Brussels, with the aim of preventing the establishment of discriminatory 
measures, in accordance with the principles of the WTO . 
3.248.   The representative of Thailand  shared the concerns raised by other delegations. He 
encouraged the EU to provide scientific justification for the use of "Palm Oil Free" labels and to 
ensure that this label would not be used to misguide consumers nor cause discrimination against 
palm oil. Thailand would continue to monitor the developme nt of this concern in the TBT Committee.  
3.249.   The representative of Malaysia  said that her delegation shared the concerns raised on palm 
oil free labelling and would continue to monitor the development of this issue in this Committee.  
3.250.   The representative of Honduras  reiterated its concern on this measure. Members had the 
legitimate right to protect human health but these measures must be compatible with the WTO 
Agreements and should not restrict trade in an unnecessary manner. Honduras was closely following 
developments on this issue in the TBT Committee.  
3.251.   The representative of the European Union  repeated responses provided in previous TBT 
Committee meetings.111 The statement "palm oil free" per se/alone was not considered as a nutrition 
claim within the meaning of Regulation (EC) No 1924/2006 on nutrition and health claims.  EU 
member States were responsible for enforc ing, monitor ing and verify ing that relevant EU food law 
requirements were fulfilled by food business operators.  
3.4.42   Thailand — New certification requireme nts under the Thai Ministry of Finance's 
Ministerial Notification on Importation of Spirits into the Kingdom of Thailand (B.E 2560) 
G/TBT/N/THA/524  (IMS ID 556112) 
3.252.   The representative of the European Union  welcomed the notification by the Thai authorities, 
on 15 November 2018, of the Ministerial Regulation entitled "Liquor Importation Permission" (B.E. 
                                                
111 G/TBT/M/76 , para. 3.231; G/TBT/M/75 , para. 4.256; G/TBT /M/74 , para. 2.46 and full statement 
contained in G/TBT/W/476 . 
112 For previous statements follow the thread under IMS ID 556  (under dates raised and references).  G/TBT/M/77  
 
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  2560 (2017)). The EU was currently examining the Regulation in detail, with a view to providing 
comments. The full statement is contained in G/TBT/W/638 . 
3.253.   The representative of New Zealand  acknowledged and supported 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 
achievi ng a legitimate public health objective. However, New Zealand exporters remained uncertain 
on certification requirements.  She asked that Thailand advise whether acceptance of other 
recogni zed industry certification, which achieved the objective of these me asures, was being 
considered. New Zealand remained keen to work with the Thai Government to ensure New Zealand 
exporters met Thailand 's objectives under these regulations through the least trade restrictive 
means.  
3.254.   The representative of Australia reiterated  previously raised concerns.113 
3.255.   The representative of Mexico  urged Thailand to clarify the issues raised and to notify any 
changes to the TBT Committee.  
3.256.   The representative of Thailand  informed the Committee that the Excise Department, the 
responsible regulatory body, was in the process of revising the Ministerial Regulation on Liquor 
Importation Permission B.E. 2560 (2017) and related laws. This was to ensure that the liquor quality 
examination and analysis were suitable for Thai society and in line with international practice by 
gathering information and opinion from experts in various fields including international organizations 
and embassies. As a result, progress might take some tim e to process properly and accurately. 
Thailand took note of all comments from members and would convey them to the regulatory 
authority in capital.  
3.4.43   China — Chinese Environmental protection control standards for imported solid 
waste as raw materials (IMS ID  551114) 
3.257.   The representative of Australia  reiterated previously raised concerns.115 A range of materials 
impacted by China 's measures were valuable inputs to recycling supply chains rather than "waste ". 
Trade in these products allow ed for the recovery of materi als which could  otherwise end up in landfill 
or the oceans.  
3.258.   The representative of China  repeated responses provided in previous TBT Committee 
meetings.116  
3.4.44   India — Testing and Certification of telegraph (The Indian telegraph (Amendment) 
Rules, 2017), G/TBT/N/IND/66  (IMS ID 558117) 
3.259.   The representative of the United State s recalled concerns expressed at the  November 2018 
meeting with the provisions contained in rules governing telecommunications -related equipment. 
Namely, the US was concerned that the proposed certification procedures would produce overlapping 
and conflicting  testing requirements through the Telecommunications Engineering Center (TEC) and 
under the Compulsory Registration Order (CRO) that were expected to result in unnecessarily 
burdensome costs for foreign companies selling telecommunications equipment in the  Indian 
market. The US recognized India 's desire to ensure the integrity and security of the country 's 
communications network. However, the US urged India to reconsider implementing domestic testing 
requirements, and to continue following standard internat ional best practices, including the 
acceptance of ILAC -accredited lab results.  She reported that t he TEC ha d announced that the 
enforcement date of the testing and certification requirements ha d been postponed with no new date 
of enforcement having been an nounced. The US asked if  India could confirm the postponement  and 
                                                
113 G/TBT/M/76 , paras. 3.241 -3.242.  
114 For previous statements follow the thread under IMS ID 551 (under dates raised and references).  
115 G/TBT/M/76 , para. 3.245 . 
116 G/TBT/M/76 , para. 3.248 and G/TBT/W/580 . 
117 For previous statements follow the thread under IMS ID 55 8 (under dates raised and references).  
 G/TBT/M/77  
 
- 43 - 
 
  asked if  TEC would continue to accept test results from international ILAC accredited labs past the 
stated  deadline of  31 March 2019 . 
3.260.   The representative of India repeated the responses provi ded at previous TBT Committee 
meetings.118 
3.4.45   United States — TSA Certification on security screening equipment 
G/TBT/N/USA/1132  (IMS ID 559119) 
3.261.   The representative of China  raised concerns with the unequal treatment of Chinese 
companies in the conformity assessment procedure performed by TSA since 2018. Firstly, in the 
process of certification, TSA had failed to inform Chinese companies of the deficiencies and results 
in a p recise and complete manner giving Chinese companies no chance to make corrections. This 
was not in compliance with Article 5.2.2 of the TBT Agreement. Secondly, China hoped that the US 
would notify the TSA certification to the TBT Committee giving Members the opportunity to provide 
comments, and thereby fulfilling the transparency requirements in TBT agreement. Thirdly, Article 
5.1.2 stipulated conformity assessment procedures were not prepared, adopted or applied with a 
view to or with the effect of creati ng unnecessary obstacles to international trade. She said TSA 
certification was undertaken in an unpredictable, unclear manner, which had negative impacts on 
trade and created unnecessary obstacle to international trade. She hoped that the US would follow 
the relevant rules laid out in the TBT Agreement by notifying this certification, treating Chinese 
companies and products equally as domestic or other members ', and not creating unnecessary 
obstacles to trade.  
3.262.   The representative of the United States  said t hat the only evidence provided by China had 
been related to government procurement which was not covered under the TBT Agreement. The US 
encouraged China to engage bilaterally as it was not a matter for discussion under the TBT 
Agreement.  
3.4.46   Egypt — Halal req uirements for Poultry Parts and Offal (IMS ID 571120) 
3.263.   The representative of the United States  reiterated previously raised concerns.121 The US 
noted that at the November 2018  meeting , Egypt had responded that it did not impose any 
restrictions on the importati on of poultry.  Egypt reported that under HS code 0207, US poultry 
exports to Egypt had increased 28 % in 2017 compared to 2016, and that there was an  almost 
3,500  % increase in 2017 compared to the average imports of the five preceding years.  The US had 
conducted its own analysis but was unable  to verify these figures and she therefore request ed further 
information from Egypt on the data sources used for these claims.  Also at the November meeting, 
Egypt had cited challenges in verifying the source of all im ported parts, the compliance of 
slaughtering houses, and difficulty in differentiating between poultry parts and raptors. However, 
she noted that Egypt 's General Organization for Veterinary Services  (GOVS) had  inspected and 
confirmed that 22 US producers i nterested in exporting to Egypt conform ed with Egyptian halal and 
food safety standards, including the traceability system.  In light of the GOVS' s existing verification , 
she request ed Egypt to remove these unjustified barriers to trade.  
3.264.   The representative of Egypt  thanked the US for the continuous interest and bilateral 
exchanges on this issue, both in Geneva and at expert -level in capital. As underscored at the 
November 2018  meeting , the importance Egypt place d on halal requirements could not  be 
emphasized enough. She said this position was fully justified by the structure and religious beliefs 
of Egyptian society. In addition, the rationale for Egypt 's halal requirements ha d been explained at 
the previous  meeting, and clarification had been  provided on how these requirements were essential 
to safeguard the values and beliefs of Egyptian  people, and consumer health . She emphasized that 
the requirements did not constitute any barrier to trade and were not applied in a discriminatory 
manner. Fina lly, she reiterated that only whole poultry was considered to be in compliance with halal 
requirements upon the verification of the concerned authorities in Egypt. In response to the question 
from the US, she said the source of the trade data used was that  notified to the Trade Map.  
                                                
118 G/TBT/M/76 , para. 3.257 . 
119 For previous statements follow the thread under IMS ID 55 9 (under dates raised and references).  
120 For previous statements follow the thread under IMS ID 571  (under dates raised and references) . 
121 G/TBT/M/76 , para. 3.26.  G/TBT/M/77  
 
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  3.4.47   Russian Federation — Federal law No 487 -FZ, providing a framework for 
comprehensive use of special labelling and traceability of goods and Decision No. 792 -r 
specifying the goods to which labelling will apply and the dates of in troduction of the 
mandatory labelling (IMS ID 567122) 
3.265.   The representative of the European Union  raised concerns on the Russian Federation's 
Decision № 792 -r, listing goods which would  be subject to mandatory marking, along with the dates 
of introduction of th ese labelling requirements for each product category. The full statement is 
contained in G/TBT/W/639 . 
3.266.   The representative of the Russian Federation  reiterated that his delegation did not consider 
the Decision of the Government № 792 -r to be a technical regulation since the decision did not meet 
relevant requirements stipulated in  the TBT Agreement. He reiterated that the adopted measure had 
been elaborated to enhance the protection of sensitive products against counterfeiting and to ensure 
the payment of all taxes. He stated that the measure fell under the purview of Article XX pa ragraph 
(d) of the GATT 1994. The Decision of the Government listed goods which would be subject to 
marking that would allow traceability of the product to tackle illicit trade. The traceability system 
had been developed in collaboration with and on the in itiative of international companies including 
European ones. The measure would enter into force for tobacco products as of 1 July 2019, until 
which time tobacco producers and importers had to register in the system. For other products, 
timelines were curre ntly being discussed between business and Government. Russia remained 
available for constructive discussions on the issue.  
3.4.48   Brazil — Technical Regulation 14, 8 February 2018, to set the additional official 
identity, quality standards for wine and derivative s of grape and wine products as well as 
the requirements to be acquainted and Technical Regulation No. 48, 31 August 2018 
published in the Official Gazette on 10 September 2018, G/TBT/N/BRA/613  (IMS ID 568123) 
3.267.   The representative of the European Union  noted that the EU wine industry exporting to Brazil 
continued to be concerned  about disruptions to trade due to the long list of analytical parameters 
and their divergences with the OIV recommendations in Technical Regulation 14 of 8 February 2018, 
which set the additional official identity, quality standards for wine and derivativ es of grape and wine 
products. The EU reiterated its invitation to the Brazilian authorities to make use, to the maximum 
extent possible, of the recommendations of the OIV when preparing its regulations on wine and to 
consider accepting imported wines made  according to oenological practices authorised by the OIV. 
The EU was prepared to work bilaterally with Brazil regarding this issue.  
3.268.   The representative of New Zealand  supported comments by the EU and encouraged Brazil 
to apply the international standards a dopted by the OIV for testing requirements and certificates of 
analysis for wine imported into Brazil. The requirements for the certificate of analysis for wine 
exported to Brazil set out in Normative Instruction 14 (IN14) 2018 posed a significant barrier to 
trade for New Zealand wine exporters. Since parameters such as total sulphates expressed as 
potassium sulphate, total chlorides expressed as sodium chloride, ash and methyl alcohol were not 
required by other markets and were at variance with parameters set by the OIV, official laboratories 
in New Zealand did not test for them. Considering Brazil 's obligations under the TBT Agreement, 
New Zealand asked Brazil how it ensured that the certificate of analysis requirements were  not more 
trade restrictive than necessary to achieve Brazil 's objectives and what the rationale was for 
departures from conformity with OIV -adopted standards.  
3.269.   The representative of Brazil , recalling to the comments made in the previous TBT Committee 
meeti ng124, reaffirmed that neither this regulation nor any other Brazilian legislation concerning the 
wine sector represented an obstacle to exports of wine from the EU to Brazil. The EU was the biggest 
seller of wine to Brazil, corresponding to around 40% of Br azil imports, ahead of Chile and Mercosur 
partners. The exports of wine to Brazil from the EU, Chile and Mercosur member states reached 367 
million dollars in 2018, with 157 million dollars allocated to the EU, attesting to the openness of the 
Brazilian ma rket and showing that Brazil did not impose unnecessary obstacles to trade and acted 
in a transparent manner regarding its commitments to developing regulations in this sector.  
                                                
122 For previous statements follow the thread under IMS ID 567  (under dates raised and references) . 
123 For previous statements follow the t hread under IMS ID 568  (under dates raised and references) . 
124 G/TBT/M/76 , para. 3.16 and the full statement contained in G/TBT/W/561 . G/TBT/M/77  
 
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  3.5  Exchange of Experiences  
3.5.1   Good Regulatory Practice  
3.270.   The Moderator's  report is contained in G/TBT/GEN/256 .  
3.5.2   Conformity Assessment Procedures   
3.271.   The Moderator's  report is contained in G/TBT/GEN/257 . 
3.272.   The representati ves of Canada  and the European Union  stressed the usefulness of sharing 
experiences, and that this was an important way of hearing different perspectives. The moderator's 
summary was a very useful source of information to bring back to capitals. In additio n, the European 
Union said that the discussion had been fully in line with what had been foreseen in the 8th Triennial 
Review , in particular on conformity assessment. This would enable delegations to draw some general 
elements and principles regarding work  on post -market controls which could be reflected in the 
future guidelines on which the Committee was about to start work.  
3.273.   The representative of South Africa , as one of the Members that had requested the session, 
said that the session had met all expectations. The information shared was very useful and would 
provide many valuable  ideas that could be followed  up on and implemented in capital.  
3.5.3   Follow -up on Commi ttee Decisions and Recommendations ( G/TBT/41 ) 
3.274.   The Chairman  said that delegati ons' key points arising during the Committee's informal 
discussions on follow -up to the 8th Triennial Review were contained in the "Aide -Memoire" document 
(JOB/TBT/273/Rev.2 ). This document was regularly updated by the Secretariat. In brief, based on 
consultations, Members saw merit to begin follow -up work in two specific streams of work , namely 
transparency and conformity assessment procedures .  
3.275.   On transparency , the Committee would hold a thematic session in June. It was proposed 
that this thematic session be webcast  (as had been those reported on above) and that Committee  
dedicate one and a half days  to the transparency thematic session (meaning that the thematic 
session would be extended from one day to one day and a half). Delegations so agreed .  
3.276.   On conformity assessment , the Chairman proposed that the Committee also use  the June 
meetings to start discussion on the topic of conformity assessment guidelines, without prejudice to 
any other areas of work that Members may wish to embark on in follow -up to the 8th Triennial 
Review,  or in response to any past  recommendations from previous triennial reviews ( contained in 
G/TBT/1/Rev.13 ). In view of this, it was suggested that the Committee set aside  time for a dedicated 
informal discussion  during the June meeting week.  In making this suggestion, the Chairman was 
mindful of the point made by some delegations at the February informal meeting that ti me was also 
needed for bilaterals. The Chairman therefore suggested the following change in schedule for the 
June meetings:  
Mon, 17 June:   No formal meeting (time left for bilaterals)  
Tue, 18 June:   Dedicated informal on CAP guidelines (am), and  
Thematic  Session on transparency (pm)  
Wed, 19 June:   Thematic Session Transparency (am and pm)  
Thu, 20 June:   Regular meeting  
Fri, 21 June:   Regular meeting  
 
3.277.   It was so agreed .125  
3.278.   The Secretariat  provided an update in respect of the validation of enquiry point 
information .126 The full statement is contained in document G/TBT/GEN/262 . 
                                                
125 The revised schedule of meetings for 2019 was subsequently circulated in JOB/TBT/262/Rev.1 .   
126 G/TBT/41 , para. 6.19 (a.i).  G/TBT/M/77  
 
- 46 - 
 
  4  TWENTY-FOURTH ANNUAL RE VIEW  
4.1.  The Secretariat  introduced document G/TBT/42 . The Committee  took note of the Report.  
5  TECHNICAL COOPERATIO N ACTIVITIES  
5.1.  A number of Members reported on technical assistance activities. The representative of 
Guatemala  informed the Committee that a National Workshop on the TBT Agreement had taken 
place in Dec ember 2018 and the representative of the United States  provided an updated on the 
work of the Standards Alliance. The full statement is available in G/TBT/W/597 . The representative 
of Chile thanked the WTO Secretariat for the 20 -22 November 2018 workshop on ePing. Three 
seminars had taken place, with officials from the governmen t, with industry, and in a regional setting 
– this was with the aim of increasing access and use of ePing. The activity had been valuable for all 
participants involved.   
5.2.  The Secretariat  provided an update on technical assistance and on ePing. The full stat emen t is 
contain ed in document ( G/TBT/GEN/ 262).  
6  UPDATING BY OBSERVER S  
6.1.  The representatives of Codex , UNECE, OIML , UNIDO127, BIPM and IEC updated the Committee 
on TBT related activities . 
6.2.  The representative of ISO informed the Committee that revision of ISO guide 59 , now called 
ISO IEC draft Guide 59 recommended practices for standardization by national bodies of ISO and 
IEC, was under way and WTO Members could comment o n the draft guide during th e enquiry stage 
through the ISO and IEC members . This consultation stage was open until 15 March 2019. Following 
that, the joint working group members developing th e guide w ould convene so as to address all 
comments received and agree on the next action s. 
6.1  Pending requests  
6.3.  The representative of South Africa  recalled his delegation's submission in the context of the 
8th Triennial Review that the Committee was encouraged to make quick decisions on pending 
observer status requests. H e urged delegations to consider these pending requests.  
7  ELECTION OF THE CHAI RPERSON  
7.1.  This agenda item was suspended until the next formal meeting.  
8  DATE OF NEXT MEETING  
8.1.  The next regular meeting of the Committee is scheduled for 20 -21 June 2019. It will be 
preceded by a dedicated informal meeting on approaches to conformity assessment procedures (18 
June am) and the thematic session on transparency on 18 (pm) and 19 June .  
 
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127 G/TBT/GEN/258 , G/TBT/GEN/259 , G/TBT/GEN/260 , G/TBT/GEN/261 .