RESTRICTED  
  
G/TBT/M/81  
 
 
26 June 2020  
(20-4448) Page: 1/123 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETI NG OF 13-14 MAY 2020:  
WRITTEN PROCEDURE ON  SPECIFIC TRADE CONC ERNS  
CHAIR MAN: MR SUNG HWA JANG  
Note by the Secretariat1 
 
On 13 and 14 May 2020, the TBT Committee held, on an exceptional basis due to the COVID -19 
pandemic, its meeting by written procedure . This was not a virtual meeting; it was an exchange of 
statements on specific trade concerns (STCs) using eAgenda. R emaini ng regular agenda items  of 
the Committee (those other than STCs),  as well as the planned thematic sessions for May , will be 
reverted to at the Committee's next meeting, currently scheduled for 28 -29 October 2020. A timeline 
for the written procedure was ci rculated on 6 April 2020 in JOB/TB T/365 ; the Airgram was issued 
on 15 April ( WTO/AIR/TBT/17 ); and, the Annotated draft Agenda was circulated on 28 April 
(JOB/TBT/366 ). According to the timeline, the written procedure took  place over three phases:  
Annotated draft Agenda (Phase 1); Written Procedure (Phase 2); and, Statements and Minutes 
(Phase 3). The minutes of this meeting compile all statements  uploaded to eAgenda by 28 May 2020.  
 
 
1   SPEC IFIC TRADE CONCERNS  ................................ ................................ ........................  1 
1.1   Withdrawn Concerns  ................................ ................................ ................................ ..... 1 
1.2   New Specific Trade Concerns  ................................ ................................ .........................  2 
1.3   Previously raised concerns  ................................ ................................ ...........................  32 
 
1  SPECIFIC TRADE CONCE RNS 
1.1  Withdrawn Concerns  
1.1.  The following STCs were withdrawn from the agenda at the request of the concerned Member . 
a. Indonesia - Recommendations to Import Horticulture Products (RIPH)  
b. Brazil - Ministry of Agriculture, Livestock and Food Supply – MAPA Ordinance 79, of 13 
May 2019 establishing a public consultation to amend the Technical Regulation 67, 5 
November 2018 regarding the pr ocedures and requirements for export and import 
certification of beverages, fermented acetic, wines and wine and grapes derived products 
(ID 597)  
 
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/81  
 
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  1.2  New Specific Trade Concerns  
1.2.1   Bangladesh – Hazardous Waste (E -waste) Management Rules, 2019, 
G/TBT/N/BGD/3  (IMS ID 6202) 
1.2.  The delegation of Canada provided the following statement. Canada welcomes this opportunity 
to discuss its concerns on transparency and clarity regarding G/TBT/N/BGD/3 , Hazardous Waste ( E-
Waste) Management Rules, 2019 , which Bangladesh notified to WTO Members on 20 February 2020. 
In its initial comments submitted on 16 April 2020, as well as on two previous occasions in 
March  2020, Canada requested that Bangladesh extend the comment perio d of the notification to 
60 days and share the full regulatory text of the Management Rules  with Canada. Canada would like 
to take this opportunity to reiterate these requests and ask Bangladesh to share the full regulatory 
text with other WTO Members and stakeholders to foster greater transparency and clarity on the 
Management Rules . While Canada trusts that Bangladesh is currently giving due consideration to 
our comments, we nevertheless use this opportunity to highlight some of our questions and concerns  
on the Management Rules . Canadian stakeholders have voiced various concerns regarding the lack 
of clarity of the proposed Management Rules  and are requesting that Bangladesh provide additional 
supportive documentation on the new measure, which they consid er as challenging to understand. 
Additional explanations would be beneficial on the scope of the measure, the selection criteria for 
the substances identified as "hazardous ", and the rationale behind the determination of the threshold 
limits for each of th em. 
1.3.  Canada would further request that Bangladesh clarify specific aspects of the Management 
Rules , notably regarding the method and rationale Bangladesh has followed to elaborate the 
grouping in Schedule 3. Some of these groups contain a broad range of sub stances, each with their 
own level of risks and hazard profiles. Some of these may not require to be grouped under the same 
threshold limit or be included in Schedule 3 altogether. This includes, for example, the broad group 
of "Mineral Wool " or the joint entry for "Nickel and Cadmium/Cadmium oxide/Cadmium Sulphide ". 
We also understand that some substances serve a specific purpose in the design of electronic 
products, like the flame retardant Tetrabromobisphenol -A, and would like to know more on the 
rationa le for their inclusion in Schedule 3. Canada would also appreciate additional information on 
how Bangladesh will be approaching enforcement of the Management Rules . In light of the various 
requests for greater engagement on this issue, Canada asks that Ban gladesh delays the adoption 
and entry into force of the Management Rules , and takes the time necessary to provide greater 
transparency so that all affected parties may assess the potential impacts of the measure and 
provide substantial comments for Banglad esh's consideration in avoiding unnecessary impacts on 
trade. Canada would also strongly encourage Bangladesh to give due consideration to any additional 
inputs or scientific evidence provided by stakeholders to ensure that the Management  Rules  are not 
more trade restrictive than necessary to meet the objectives of Bangladesh, specifically with regards 
to the categories and threshold limits of Schedule 3. This would help ensuring that the new measure 
does not generate unnecessary complexity and uncertainty in global trade. Canada thanks 
Bangladesh for its future engagement on this specific trade concern (STC)  and looks forward to 
receiving written answers on our letter of comments sent on 16 April 2020.  
1.4.  The delegation of the United States  provided the follow ing statement. The United States thanks 
Bangladesh for providing notification of the Hazardous Waste (E -waste) Management Rules, 2019, 
including a summary, excerpted translation of two clauses, and a threshold limits schedule for the 
management of electron ic waste products. However, we note that because Bangladesh did not notify 
the entire draft text of the proposed e -waste rules, stakeholders cannot reconcile the changes from 
previous versions. We ask that Bangladesh notify the entire updated measure to th e WTO and 
provide a public comment period of at least 60 days. Bangladesh should consider stakeholders' 
comments in preparing revisions before implementing new e -waste rules. Can Bangladesh provide 
us with information as to when these draft e -waste rules c ome into force? Without additional 
information, we also remain concerned about the unintended consequences of this new policy as it 
may ban products ranging from television sets to life -saving medical devices and critical medical 
equipment such as lead shi elding for x -rays. Additionally, the import of used or refurbished electrical 
and electronic equipment also appears to be banned by this measure. There is no indication whether 
industry will be able to import refurbished and repaired electrical and electro nic equipment. This 
practice could extend the lifetime of millions of dollars of valuable equipment. We encourage you to 
speak with the relevant ministries to ensure that the rules accomplish the intended goals of 
 
2 For previous statements follow the thread under IMS ID  620 (under dates raised and references) . G/TBT/M/81  
 
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  protecting the health and welfare of Bangl adeshi citizens, while not restricting the access of 
consumers in Bangladesh to the global supply of goods and products.  
1.5.  The delegation of the Russian Federation  provided the following statement. On 20 February 
2020, Bangladesh notified its Hazardous Waste  (E-Waste) Management Rules, 2009 
(G/TBT/N/BGD/3 ) to the WTO. Following notification, on 10 March 2020, Russia sent comments to 
Bangladesh's TBT Enquiry Point. We thank Bangladesh for the opportunity to comment on its draft 
Rules. Although  Russia believes that our comments are being co nsidered and will be replied to soon, 
we would like to underline some of our concerns. Specifically, Schedule 3 of the draft Rules 
establishes a list of hazardous substances. No explanation is provided as to what criteria were used 
to identify substances a s hazardous. Schedule 3 also sets a threshold limit for each hazardous 
substance. Within five years from the enactment of the draft Rules, specified hazardous substances 
in electrical and electronic products shall be below threshold limits provided in the Schedule. The 
Russian Federation notes that Schedule 3 lists nickel metal as hazardous and includes it in a group 
with cadmium and two cadmium compounds. This grouping appears to be incorrect due to significant 
differences between nickel and cadmium in ter ms of substance identity and hazard profile. The 
maximum nickel and cadmium content for products that fall within the scope of the draft Rules is 
set at an extremely low level, namely at 0.1%. For this reason, the Russian Federation requests that 
nickel sh ould be considered separately and moreover should be entirely removed from the draft 
Rules.  
1.6.  Russia emphasizes that the draft Rules seem to effectively prevent the use of high -quality 
nickel -containing stainless steel, which enhances the longevity of electr onic equipment. Also, 
stainless steel plays an important role in medical equipment, as the material not only withstands 
corrosion, but is also easy to clean and to disinfect. The measure at issue may affect the use of 
nickel coatings, which play an essenti al role in many electrical and electronic products. The Russian 
Federation stresses that nickel is not classified by the International Agency for Research on Cancer 
and any major WTO Member as carcinogen, mutagen and reprotoxine (CMR) of categories 1A or 1 B 
substance and it has no other hazardous properties that would suggest singling it out in a short list 
of hazardous substances that should be avoided in electrical and electronic products. In case of 
adoption of the draft legislation, we note the contradi ction between the measure itself, and its 
declared objective to tackle the problem of e -waste. Without the use of nickel -containing stainless 
steel, the life span of many of the products that fall within the scope of Bangladesh's regulation 
would be shorte r, thus aggravating e -waste problem.  
1.7.  Russia considers the measure to be more trade restrictive than necessary, as the inclusion of 
nickel in the list is not scientifically justified and has the potential to create unnecessary obstacles 
to international tra de in a wide range of nickel -containing products. Besides, according to the 
notification ( G/TBT/N/BGD/3) , the period for comments in respect of the draft Rules was limited to 
March 2020, but the measure was notified on 20 February 2020. Russia kindly reminds Bangladesh 
that in accord ance with Article 2.9 of the TBT Agreement, Members should provide the period for 
comments on draft technical regulations not less than 60 days. Bearing all these factors in mind, the 
Russian Federation suggests that Bangladesh: (i) make a revision of the document to remove nickel 
from the Schedule 3 as it is not classified as CMR 1 A or 1B; (ii) provide Members of the WTO with 
the criteria used to include substances into the Schedule 3 in order to improve transparency and 
justification of the list; (iii) us e appropriate methodologies approved at the international level when 
forming the list of hazardous wastes, including a proper hazard and feasibility assessment; 
(iv) conduct socio -economic assessment for the consequences of the draft measure for Bangladesh 's 
and global economy; (v) take into consideration legitimate objectives when elaborating technical 
regulations, as well as conditions that require scientific justification under Article 2.2 of the TBT 
Agreement; (vi) follow the transparency provisions und er Article 2.9 of the TBT Agreement; and 
(vii) respond to the Russian comments sent to Bangladesh's TBT Enquiry Point in March 2020. We 
would like to emphasize that Russia remains open for bilateral consultations with Bangladesh on this 
issue.  
1.8.  The delegation of the European Union  provided the following statement. The European Union 
has concerns on the hazardous waste man agement rules. We sent written comments to Bangladesh 
in April 2020 and are looking forward to receiving written replies before the adoption of the notified 
drafts. Our main point is that the notified draft restricts use of substances that are not restrict ed by 
any existing international legislation and thus creates more restrictions to trade than necessary. The 
EU would be grateful if the above -mentioned comments could be taken into account and replied to 
before adoption of the notified draft.  G/TBT/M/81  
 
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  1.9.  In response,  the delegation of Bangladesh  provided the following statement. Bangladesh 
thanks Members for the concerns raised, which are still being reviewed by our competent authorities 
in capital. We will revert back once we have more detailed replies. Bangladesh ha s extended the 
comment period on notification G/TBT/N/BGD/3  until 30 June 2020, notified in 
G/TBT/N/BGD/3/Add.1 . 
1.2.2   Viet Nam – Draft Circular replacing the Circular No.05/2019/TT -BTTTT dated 9 July 
2019 specifying the list of products and goods with unsafe capability under management 
responsibility of Mini stry of Information and Communications, G/TBT/N/VNM/161  (IMS 
ID 6213) 
1.10.   The delegation of the United States  provided the following statement. The United States 
thanks Viet Nam for its recent notification of the draft Circular  "Regulations on list of products and 
goods liable to cause  unsafety under the governance of the Ministry of Information and 
Communications (MIC) " as G/TBT/N/VNM/161 . We understand this circular replaces Circular No. 
05/2019/TT -BTTT. The U S Information Technology Industry Council (ITIC) provided Viet Nam 
comments through MIC and the U S Enquiry Point on 23 March 2020. We received substantive 
responses on 17 March 2020. ITIC again responded on 27 April 2020. We appreciate the robust 
discussion of this measure through the enquiry points. Our understanding is the draft Circular will 
go into eff ect on 1 July 2020, less than two months after Viet Nam plans to release the final measure 
on 10 May 2020. This short transition period does not allow a reasonable interval for stakeholders 
to come into compliance with the requirements and will likely caus e significant delays to international 
trade of impacted products. We ask Viet Nam to implement at least a one -year transition period 
after the measure is finalized to allow stakeholders to adapt their products and methods of 
production to the new requireme nts. 
1.11.   We also understand that the draft Circular may invalidate existing Type Approval (TA) and 
Suppliers' Declarations of Conformity (SDoC) certificates. Can Viet Nam please confirm our 
understanding? We would request that Viet Nam continue to recognize th e validity of existing TA 
and SDoC certificates until their expiration. Invalidation of existing certificates would be costly and 
overly burdensome for companies that have already spent time and money on the required existing 
certifications for Viet Nam. O ur understanding from U S industry is that Viet Nam does not currently 
have any established laboratories qualified to test a number of products listed in the draft Circular. 
This situation would make compliance with the regulations impossible within the cur rent specified 
transition period and create a significant testing backlog. When does Viet Nam expect a majority of 
its existing approved laboratories to be qualified to conduct this scope of testing?  
1.12.   In response, the delegation of Viet Nam  provided the fol lowing statement. The draft Circular 
amending and supplementing a number of articles of Circular No.05/2019/TT -BTTTT was notified to 
WTO Members in notification G/TBT/N/VNM/161  with 60 days granted for comments. In this draft 
Circular, the list of goods liable to cause unsafety was  updated with the technical regulations QCVN 
86:2019/BTTTT, which was promulgated in November 2019 and shall enter into force on 1 July 2020. 
This national technical regulation was previously notified to WTO on 25 March 2019 in notification 
G/TBT/N/VNM/138  with 60 days granted for comments. Since then Viet Nam had not received any 
comment from WTO Members. Therefore, the enterprises have had more than six months from the 
date of promulgation of the above -mentioned technical regulation to prepare for applica tion and TBT 
Agreement Article 2.12 was met in this case. Viet Nam will follow and designate and recognize the 
competent testing labs under the new technical regulation before the date of its entry into force. 
After this date, directions will be given to s pecific cases where the competence of testing labs is not 
satisfactory. Meanwhile, Viet Nam has also recommended foreign testing labs (including those from 
US) to have them registered for recognition under a Mutual Recognition Agreement (MRA) . 
1.2.3   India – Draft Chemicals (Management and Safety) Rules, 2020 (IMS ID 6224) 
1.13.   The delegation of the United States  provided the following statement. The United States has 
repeatedly asked India to notify its Draft Chemicals (Management and Safety) Rules to the WTO. 
The fir st request was on 20 December 2019, and we again requested notification on 23 March 2020. 
When will India notify this measure? On 6 March, the US Enquiry Point submitted comments from 
the U S industry concerning this draft measure. The Indian Enquiry Point has acknowledged these 
 
3 For previous statements follow the thread under IMS ID  621 (under dates raised and references) . 
4 For previous statements follow the thread under IMS ID  622 (under dates raised and references) . G/TBT/M/81  
 
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  comments. We note industry's concerns that India has included in the Draft Rules a list of 750 
chemicals, classified as "Priority Substances, " without any public consultation. U S industry is also 
concerned about the potential trade d isruptions that may result from the criteria used by the Draft 
Rules' risk management system. It bases the identification of Priority Substances on the mere 
presence of certain chemicals, rather than on assessments of actual risk of chemical exposure to 
humans or the environment. We urge India to consider risk -based approaches in identifying and 
prioritizing chemicals for regulatory action. We note that the broad criteria of the Draft Rules' 
proposed risk management system could affect many products already  regulated in India under 
other relevant regulations, such as cosmetics, pharmaceuticals, and agricultural pesticides. Has 
India considered exemptions for other affected products (e.g. polymers) controlled under other 
regulations?  
1.14.   We request that India cla rify stakeholder engagement as outlined in Chapters II and III of the 
Draft Rules. For example, how will the Chemistry Division work with manufacturers to designate a 
chemical as a "Substance for Registration? " We also ask that India provide further clarif ication as to 
how it defines intermediates. Do the same registration and testing requirements apply to 
intermediates that are restricted in Schedule VI? We observe that when additional testing is required 
to fulfil data requirements for substance registrat ion, the Draft Rules mandate that such testing 
occur in India. We request India ensure that results of conformity assessment procedures conducted 
outside of India are also accepted to fulfil these data requirements. Industry notes that it needs a 
grace per iod of more than six months after final adoption of the Draft Rules in order to adapt products 
and methods of production to the new requirements. Additionally, due to the broad scope of the 
Draft Rules, we request that India consider launching its system i n phases, working with industry 
stakeholders to determine a reasonable timeframe for phased implementation.  
1.15.   In response, the delegation of India provided the following statement. India thanks the United 
States for their interest in India's Draft Chemicals (Management and Safety) Rules, 2020. India 
would like to inform the Members that the Draft Chemicals (Management and Safety) Rules 2020 is 
yet to be finalized. It has been circulated among the industry associations as part of extensive 
stakeholders' consul tation, which is completely an internal exercise. Once the draft is finalized, it 
will be notified to WTO TBT Committee for circulation to Members, providing them opportunities to 
comment within a reasonable time period.  
1.2.4   Colombia – Issuing the Technical Re gulation on rational energy -use labelling for 
certain types of electrical and gas end -use equipment, for marketing in Colombia, 
G/TBT/N/COL/212/Add.6  (IMS ID 6235) 
1.16.   The delegation of the Republic of Korea  provided the following statement. Korea would like to 
make some co mments regarding this regulation as follow. With regard to the amend ed provisions 
for air conditioners, Korea understands that the criteria which have been previously adopted 
separately by product group (Room air conditioner and Compact terminal equipment / Air 
conditioning equipment) will be integrated into one and slightly stronger criteria will be applied by 
the time frame . The first criteria will be applied from the date of entry (not determined) to 
31 December 2021 (hereinafter called "1st stage"), and stronger criteria will be applied from 
1 January 2022 (hereinafter called "2nd stage"). Air conditioner manufacturers and distributors have 
a concern regarding the application schedule of this regulation. As the effective date has not been 
determined yet, effective date of regulation is expected to be after the second half of 2020. In this 
case, the date of enforcement will be after the second half of 2021, thus the criteria of 1st stage will 
be applied in a short period of less than six months from the enf orcement date to 31 December 
2021. The new criteria will be applied after 1 January 2022. In such a case, the company might have 
an administrative and costly burden because of changing the label twice in a short period. Changing 
technical regulation twice in a short period is considered undesirable for the people of Colombia in 
terms of operating a stable system. Therefore, please let us know if the Colombian government has 
any information on the effective date of this regulation, and Korea would like to kn ow an alternative 
to this matter if the effective date is delayed as stated above.  
1.17.   The delegation of the United States  provided the following statement. The United States 
thanks Colombia for notifying its draft technical regulation on "Rational Energy Use Labelling for 
Certain Types of Electrical and Gas End Use Equipment, for Marketing in Colombia", as 
G/TBT/N/COL/212/Add.6 . We notice  that the draft resolution references "AHRI Standard 1360 " for 
 
5 For previous statements follow the thread under IMS ID  623 (under dates raised and references) . G/TBT/M/81  
 
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  the testing of the "Datacom Cooling " product. We applaud Colombia for referencing this international 
standard. However, we are concerned that the draft resolution lacks reference to the accepta nce of 
international standards, such as other AHRI standards, for other products covered in this resolution. 
We urge Colombia to revise the resolution to expand the acceptance of international standards and 
avoid duplicative testing and unnecessary delays to international trade. The United States is 
concerned that by not referencing the other international standards, products demonstrated to be 
of high efficiency and quality are either delayed or denied market entry, thus reducing consumer 
choices and compr omising Colombia's energy efficiency goals.  
1.18.   In response, the delegation of Colombia  provided the following statement. We should like to  
thank the Republic of Korea and the United States for the information and comments relating to the 
draft resolution amen ding labelling requirements and clarifying a number of requirements 
established in the general annex to the technical regulation s on energy efficiency labelling.  In this 
connection, the Colombian Ministry of Mining and Energy states that the draft amendmen t to the 
technical regulation s on labelling seeks to harmonize energy efficiency ranges for air conditioners, 
in order to facilitate compliance with technical requirements, and the entry into force of the new 
reference values has been set for 1  January  2022. As regards the concern raised by the Republic of 
Korea on the requirement of two labels for a single air conditioning product over a short period, 
Colombia states that, due to the health emergency caused by COVID -19 and other factors mentioned 
by the pa rties interested in updating the technical regulations on labelling, a date of issue for the 
regulatory amendment cannot be determined at this time. In response to the concerns of the 
Republic of Korea, the Ministry of Mining and Energy will evaluate the a lternative of amending the 
proposed dates for the change in energy efficiency ranges. Finally, we should like to clarify that the 
change in reference values does not necessarily mean that tests or other related procedures will 
have to be performed again to  demonstrate conformity. As  long as the conditions are the same as 
for the first label, the product may be reclassified (where applicable) using the same results 
according to the new energy efficiency ranges.  
1.2.5   Russian Federation; Kazakhstan; Kyrgyz Republic ; Armenia – Requirements for 
energy efficiency of energy related devices (IMS ID 6246) 
1.19.   The delegation of the Republic of Korea  provided the following statement. Korea would like to 
make some comments regarding this regulation as follow s. The Decision Nr 11 4, adopted by the 
Decision of the Council of Eurasian Economic Commission was released via the EAEU webpage on 
8 August 2019. WTO Member states, however, had no opportunity to submit their comments 
because Russia, Kazakhstan, Kyrgyz and Armenia failed to c omply with the obligation of the WTO 
TBT notification. Regarding the regulation, Korea has concerns over the compliance with the WTO 
TBT Agreement and specific regulations for a few devices, and would like to make requests as 
follows. The first is with reg ards to the WTO TBT Agreement. Four of the EAEU member States, 
which are also WTO Members, shall comply with the notification procedure to collect comments from 
all of the WTO Members under the WTO TBT Agreement. Therefore, in accordance with Article 2.9 
of the WTO TBT Agreement, we request a period of at least 60 days for the notification procedure, 
during which time the WTO Member stakeholders may express their opinions regarding the Decision.  
1.20.   The second concerns requests following a review by our side. K orea understands that the 
Decision reflects the previous version of internationally recognized EU standards and an amendment 
draft of the EU standards. In this regard, Korea is concerned that the level of some regulations by 
item is excessive or the timeli ne before the date of entry into effect is too tight. Therefore, Korea 
would like to make the following four (4) requests listed below:  
a. Televisions (Annex 4) : All types of television displays will enter into effect in September 
2021. However, manufacturers are having difficulties in complying with this Decision for 
products such as micro LED and high resolution (4K+) displays which is required very new 
technologies. The recently revised EU regulation will enter into effect from 2023 to 
encourag e the commercialization of micro LED display products. Therefore, in line with 
international standards, we ask for the date of enforcement to be no earlier than 2023.  
b. Standby mode electric power consumption (Annex 5) : The energy consumption of 
equipment in  standby mode is excessively higher than other major countries (e.g. 0.5  W 
in the US and EU countries) and applied discriminatively to different working mechanisms 
 
6 For previous statements follow the thread under IMS ID  624 (under dates raised and references) . G/TBT/M/81  
 
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  (0.1 W for automatic and 0.3  W for mechanical). We therefore ask for an explanation of 
the scientific grounds as to why the standby power criteria have been set higher than the 
international level (0.5  W). 
c. Vacuum cleaners (Annex 16) : As the test standard for vacuum cleaners is currently unclear 
and the international standard i s still in the stage of revision, no country has enforced any 
test standard for vacuum cleaners at the present time. It will be necessary to enforce this 
provision once the corresponding international standard has been released.  
d. Labelling : Although labelli ng shall be written in the Russian language, it is also required to 
be written in state language at the request of a member State. This could entail a burden 
for businesses. The EU and G CC Standardisation Organisation (GSO)  member States do 
not regulate th e energy label to be written in their local language. Korea therefore asks 
that a single unitary language for labelling within the EAEU member States.  
1.21.   Lastly, it would be appreciated if you inform us of any information regarding confirmation of 
the final version or any additions or changes to the procedures and timeline prior to enforcing the 
Decision.  
1.22.   In response, the delegation of the Russian Federation  provided the following statement. The 
Russian Federation as well as Kazakhstan, Armenia and Kyrgyz Rep ublic would like to thank Korea 
for its interest in the Eurasian Economic Union's requirements on energy efficiency for energy -using 
devices. The Technical Regulation "On requirements on energy efficiency for energy -using devices " 
was adopted on the 8 Augu st 2019 and enters into force upon adoption of the decision of EAEU 
Council setting labelling requirements for energy -using devices, but not earlier than 1 September 
2021. The technical regulation applies to energy -using devices, including refrigerators, T V sets, 
electric bulbs, household and office equipment, etc. The document has been drafted in close 
cooperation with the business community, including multinational companies producing these 
devices. Korean companies were also involved in this process. All  requests voiced by Korea will be 
conveyed to the Eurasian Economic Commission for proper consideration with the EAEU's member 
States. The Russian Federation as well as other members of the EAEU are open for consultations 
with the Korean delegation on thes e issues.  
1.2.6   United States – Guidance on Federal Conformity Assessment Activities, 
G/TBT/N/USA/1587  (IMS ID 6257) 
1.23.   The delegation of the European Union  provided the following statement. The European Union 
would like to signal its concerns with regard to the proposed revision to the G uidance on Federal 
Conformity Assessment Activities (15 CFR Part 287) by the National Institute of Standards and 
Technology (NIST), notified on 4 March 2020. Specifically, first, the language of the Guidance seems 
to suggest that agencies may deviate from the NIST Guidance on Federal Conformity Assessment 
Activities in the exercise of their regulatory competences. Could the US clarify if this assumption is 
correct? If so, could the US further clarify what type of actions NIST may take to ensure coherence 
on conformity assessment at federal level in case an agency decides to deviate from the NIST 
Guidance on Federal Conformity Assessment Activities? Secondly, the Guidance removes "the 
responsibility for NIST to collect and disseminate information on Federal, State and private sector 
conformity assessment activities ". The European Union considers that the use of multiple on-line 
sources might entail difficulties for domestic and overseas stakeholders in having access to and 
obtaining a comprehensive overview of  the different conformity assessment schemes that may exist 
at Federal, State and private levels in the US. The setting up of a single portal providing information 
on conformity assessment in the US would overcome these difficulties and better ensure 
transparency requirements.  
1.24.   Thirdly, the Guidance also removes "the standards and conformity assessment related 
organizational names as examples (§287.4).  The inclusion or exclusion of names may be perceived 
as endorsement or criticism. " This deletion concerns in particular the organizations named in 
§287.4(d) of current 15 CFR Part 287 that include among others "the International Organization for 
Standardization (ISO), the International Electrotechnical Commission (IEC), the International 
Telecommunications Uni on (ITU) and the Organization for Economic Cooperation and Development 
(OECD), the World Health Organization (WHO), and the Codex Alimentarius Commission. " In 
 
7 For previous statements follow the thread under IMS ID  625 (under dates raised and references) . G/TBT/M/81  
 
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  parallel, the notified draft measure refers, among others, to the NIST Special Publication 2000 -01 
"ABC's of Conformity Assessment " which acknowledges the role and relevance of the conformity 
assessment standards developed by ISO and IEC and further states that "The combination of 
geographical reach and a multi -stakeholder development approach creates  wide support and use of 
the CASCO toolbox. " (see page 6). The same applies to the NIST Special Publication 2000 -02 
"Conformity Assessment Considerations for Federal Agencies ", which repeatedly makes reference to 
the ISO/IEC conformity assessment standards  and encourages agencies to make use of them. As a 
consequence, the explanations included in the notified draft measure as regards this change seem 
to entail a contradiction as, on the one hand, the proposed revision removes names of relevant 
international  standard -setting organizations as their inclusion may be perceived as endorsement 
and, on the other hand, the proposed revision refers in parallel to other relevant NIST publications 
which expressly acknowledge and endorse the relevance of these organizat ions in setting up relevant 
international conformity assessment standards. The European Union therefore considers that an 
exemplary reference to ISO and IEC should be kept as relevant international standard -setting 
organi zations in the field of conformity assessment. The same approach should apply to the 
references to ITU, OECD, WHO, and Codex Alimentarius Commission that are proposed to be 
removed, given the relevance of these organizations in defining relevant international conformity 
assessment standards . 
1.25.   Fourthly, when it comes to the acceptance of conformity assessment results, the Guidance 
introduces further changes to "reflect that U.S. access to international markets is achievable through 
many mechanisms. (…) The revised language recognizes that othe r mechanisms (not just 
recognition) can facilitate acceptance of standards and conformity assessment results to increase 
market access for U.S. products and services. " However, the notified draft measure does not provide 
any further explanations on the oth er mechanisms that could facilitate the acceptance of US 
standards and conformity assessment results. Can the US further elaborate on these additional 
missing examples? Fifthly, in accordance with the Guidance, the new responsibilities of NIST include 
"(f) To the extent that resources are available and upon request by a state government agency, 
work with that state agency to reduce duplication and complexity in state conformity assessment 
activities. " The European Union considers that the above language doe s not sufficiently encourage 
or promote the mutual recognition of conformity assessment results at state level. To the contrary, 
it seems to suggest that each state retains broad discretion in not using or recognizing conformity 
assessment results of Federal agencies or other states. This entails a serious risk of fragmentation 
and duplication of conformity assessment activities, leading to unnecessary costs and time delays in 
placing products on the US market. In this regard, could the US explain how it intends to ensure 
that the selection and use of conformity assessment procedures by a state that does not accept or 
recogni ze conformity assessment results from Federal agencies or other states does not constitute 
an unnecessary duplication in conformit y assessment activities?  
1.26.   In response, the delegation of the United States  provided the following statement. The United 
States thanks the European Union for its comment on G/TBT/N/USA/1587  as received on 7 April and 
confirmed by the U S Enquiry Point. The guidance was notified for transparency as it will, in part, 
implement the U S obligations to the WTO Agreement  on Technical Barriers to Trade under Article 
15.2. The guidance is neither a technical regulation nor a conformity assessment procedure. Instead, 
it is a guidance for U S federal agencies to use as they rely on conformity assessment to meet agency 
requirements. Therefore, this measure is inappropriately listed as a specific trade concern in the 
WTO TBT Committee agenda. Substantive comments will be addressed when the final gu idance is 
published in the U S Federal Register. The final guidance will also be notified to the WTO. We would 
welcome bilateral discussion with the EU on this guidance if further information is needed.  
1.2.7   European Union – Revision of the Batteries Directive ( IMS ID 6268) 
1.27.   The delegation of Japan  provided the following statement. Japan recognizes that the EU 
intends to amend the Batteries Directive by October this year and is considering introducing 
regulations that cover not only in -vehicle batteries but all ba tteries, focusing on : (i) ethical sourcing 
of raw materials ; (ii) measuring the carbon footprint of battery manufacturing ; (iii) facilitating reuse, 
repurposing and recycling ; and ( iv) management of toxic substances in battery production, in the 
amendment of the directive. In the review process for the directive, the EU has proposed : 
(i) requiring extreme durability of in -vehicle batteries, for example, 10 years or more ; and  
(ii) requesting detailed information on batteries, etc. Japan requests that the EU ensure that any 
 
8 For previous statements follow the thread under IMS ID  626 (under dates raised and references) . G/TBT/M/81  
 
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  revision of the directive will not be more trade restrictive than necessary . Furthermore, in the Electric 
Vehicles and the Environment (EVE) informal group of the United Nations World Forum for 
Harmonization of Vehicle Regulations (WP29), t he participating countries and regions, including 
Japan and EU, are working together to discuss the development of international standards for in -
vehicle batteries. The group's proposal is expected to be finalized in June 2021. According to 
Article  2.4 of the TBT Agreement, where completion of relevant international standards is imminent, 
WTO Members shall use them as a basis for their technical regulations. Therefore, Japan asks the 
EU to consider taking the discussions in the UN/WP29 into account in the r evision of the Batteries 
Directive. In addition, since the EU is considering the short time frame  ending October of this year 
for the revision, Japan is concerned whether the comments or inputs from Member countries will be 
fully reflected in the revision o f the regulation. Japan requests that the EU ensure that the regulation 
will be amended in a transparent manner, including : (i) ensuring the opportunity for stakeholders 
to submit their comments; (ii) timely TBT notification that allows the comments from M ember 
countries to be taken into consideration ; and (iii) providing an adequate period between the 
publication of the revised directive and its entry into force.  
1.28.   In response, the delegation of the European Union  provided the following statement. The 
Europe an Union would like to thank Japan for its interest in the planned amendment of the EU 
Batteries Directive. The EU would like to clarify that the European Commission is currently working 
on a preparation of a proposal for a new regulatory framework repeali ng the Batteries Directive. If 
adopted by the Commission, the proposal would be submitted to the Council and the Parliament in 
the framework of the Ordinary Legislative Procedure. The decision -making process in the EU usually 
takes approximately 18 to 24 m onths from the submission of the Commission proposal. 
Differentiated deadlines and targets would be foreseen in the revised measure, which would provide 
sufficient time for economic operators to adapt.  
1.29.   The EU would like to note that the current Batteries D irective already covers all type of 
batteries, including those used in electric vehicles. The legislative proposal under preparation aims 
at an integrated and comprehensive approach covering the whole life cycle of batteries and the 
whole value chain. This  should include, inter alia , sustainability requirements related to the 
responsible sourcing of raw materials for battery manufacturing, and their associated carbon 
footprint, which would improve their overall environmental performance and sustainability in a non -
discriminatory manne r. The Commission is also considering to propose new end -of-life provisions 
for all types of batteries, provisions on durability of batteries and on adequate consumer information. 
The European Union would like to assure Japan that it is fully committed to the on -going  international 
efforts under the E VE informal group of the United Nations World Forum for Harmonization of Vehicle 
Regulations (WP29). Finally, the European Union would like to note that a stakeholder consultation 
took place as part of the prep aration of the Commission proposal. The European Union will comply 
with its transparency obligations under the TBT Agreement and will notify the Commission proposal 
to the WTO TBT Committee in due time, providing sufficient comment period to WTO Members.  
1.2.8   European Union – Non-renewal of the approval of the active substance mancozeb, 
G/TBT/N/EU/712  (IMS ID 6279) 
1.30.   The delegation of Colombia  provided the following statement. Colombia wishes to express its  
concern regarding the measure notified by the European Union in document G/TBT/N/EU/712  of 
17 April 2020 relating  to the non -renewal of the approval of the active substance mancozeb, given 
that this substance is vital to pest control for a wide variety of crops.  The EU has been adopting 
measures resulting in the non -approval of the use of plant protection products, w hich is affecting 
the exports of its trading partners. Measures on the suspension or non -approval of the marketing of 
numerous active substances and the subsequent reduction of their maximum residue levels (MRLs) 
to the minimum detection level are being ta ken without any sound scientific evidence and without 
proof that such measures are the least trade -restrictive means of achieving an appropriate level of 
protection for consumers . Mancozeb is a fungicide that has been registered since the 1960s. It has 
been used in more than 70  fruit and vegetable crops across the world to control over 400 
phytopathogenic fungi that severely attack the crops. However, the main use of mancozeb is to 
prevent the fungi from developing resistance to curative fungicides (by usin g it in combination with 
them), helping to ensure that these fungicides remain effective.  
 
9 For previous statements follow the thread under IMS ID  627 (under dates raised and references) . G/TBT/M/81  
 
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  1.31.   In Colombia, the use of the active substance mancozeb is essential in agricultural production 
for protecting banana crops against pests and diseases, such as Black Si gatoka, a devastating 
disease that attacks the foliar system and is caused by the fungus Mycosphaerella fijiensis. This 
fungus is extremely dangerous and is classed as very high risk by the scientific authorities (Fungicide 
Resistance Action Committee) due  to its ability to adapt rapidly to climatic changes and, above all, 
its inherent capacity to develop resistance to various chemical groups of fungicides.  This fungus 
currently shows resistance to three different chemical groups of fungicides used, which i s severely 
limiting the control of the disease. This is why the use of mancozeb is of such importance in 
banana -producing countries. Recently, the EU also banned the marketing of chlorothalonil, which is 
the main tool for controlling Black Sigatoka. In thi s regard, banning mancozeb (an alternative 
substance) would leave banana -producing countries without any phytosanitary tools to control this 
disease, resulting in significant economic losses in Latin American countries.  Such measures would 
be in disregard of Article 2.2 of the TBT Agreement, which provides that technical regulations shall 
not be more trade -restrictive than necessary to fulfil a country's legitimate objective. In this case, 
there is no known method for producing bananas that is more effectiv e than the method involving 
the use of the above -mentioned active substances to control Black Sigatoka.  
1.32.   In addition, due to the limited number of chemical groups of fungicides available/alternatives 
for the control of Black Sigatoka in banana crops, the ri sk of the fungus developing resistance is 
extremely high. Mancozeb has been used effectively, with no signs of resistance reported, which has 
reduced the amount and frequency of the applications of this substance on crops. There is evidence 
that the absenc e of mancozeb, combined with the lack of products having a similar effect, could 
cause the resistance shown by the fungus to increase to the point of no return, where phytosanitary 
management is difficult. This would have catastrophic consequences on banan a crops, as well as on 
the agricultural producers whose livelihoods depend on them.  Many regions across the world produce 
bananas and they are a key part of agricultural exports. In this regard, there must be appropriate 
technical phytosanitary management of the crop and it must be environmentally sustainable. The 
absence of any of these pillars could mean that banana production would no longer be viable.  
1.33.   A review of the EU's draft regulation shows that the scientific justification for the 
changes/amendment s to regulations on active substances is becoming less relevant. For example, 
the decision on the non -renewal of the approval of mancozeb has been taken using a hazard -based 
approach and applying the precautionary principle. This means that the lack of inf ormation and 
scientific studies in the EU required to make a risk - and science -based decision has been overlooked, 
contrary to the provisions of the WTO TBT Agreement.  The foregoing also constitutes a violation of 
Article 2.2 of the TBT Agreement, since, a s has been indicated, there is insufficient information to 
establish criteria for the acceptance or rejection of mancozeb. This is because, from a scientific point 
of view, its effect on health and the environment has not been clearly determined. It is the refore 
crucial for the EU to use a risk assessment approach in the analysis of this regulatory change, given 
that it lacks sufficient and conclusive scientific studies from EU member States to determine the 
various toxicological aspects that may affect hum an health. There are even preliminary findings that 
point to a safe use of mancozeb within the EU.  
1.34.   Furthermore, it should be noted that there are scientific opinions at the European level that 
indicate that mancozeb is not an endocrine disruptor. On that b asis, a scientifically sound evaluation 
would only be possible if sufficient time is granted to generate information from countries, in order 
to conduct a risk assessment of all scientific studies available that include the corresponding levels 
of exposure  for determining the safety thresholds for mancozeb.  In light of the above, Colombia 
considers that the draft technical regulation amending EU Regulation No.  1107/2009 (non -renewal 
of the approval of mancozeb) must take into account the scientific evidence  and banana production 
processes and methods in countries that may be affected by the implementation of the regulation, 
in order to avoid creating an unnecessary technical barrier to trade.  
1.35.   Moreover, with regard to the deadlines established in notification  G/TBT/N/EU/712  of 
12 May 2020, we would be grateful if the EU could provide greater clarity regarding the timeframe 
for the adoption of the measures. In this respect, we wish to recall that, in accordance with Article 
2.12 of the TBT  Agreement, Members shall allow a rea sonable interval between the publication of 
technical regulations and their entry into force in order to allow time for producers in exporting 
Members, and particularly in developing country Members, to adapt their products or methods of 
production to the requirements of the importing Member.  In addition to the above, the health and 
scientific authorities in all countries, including Colombia, have been forced to focus on addressing 
the situation that has arisen as a result of global COVID -19 health emergenc y. Similarly, key sectors G/TBT/M/81  
 
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  such as food producers, organizations and associations are making significant efforts to ensure 
biosecurity controls in the fruit and vegetable supply chain. This is reducing their ability to analyse 
draft regulatory measures and thus to adjust production methods accordingly, creating additional 
burdens on international trade in food products and hampering worldwide economic recovery efforts, 
particularly in developing countries.  
1.36.   In light of the arguments presented, Colombia reques ts the EU to renew the approval of 
mancozeb and maintain its MRLs as a risk management measure to guarantee the health of 
consumers in the EU and facilitate trade for its partners. It is worth highlighting that a potential ban 
and consequent reduction of M RLs in the EU for chlorothalonil and mancozeb (an alternative 
substance) would leave Black Sigatoka control programmes without any phytosanitary tools, 
resulting in highly regrettable consequences for the environment and the economic sustainability of 
banana crops in all banana -producing countries. Such countries would also see social consequences, 
bearing in mind that in Colombia, for example, over 35,000 people directly and some 120,000 
indirectly depend on the production of bananas exported to the EU for  their livelihoods.  
1.37.   The delegation of Brazil  provided the following statement. Brazil would like to raise a concern 
regarding the non -renewal of the approval of the active substance mancozeb, according to 
notification G/TBT/N/EU/712 . Mancozeb is a substance whose use is approved for many different 
crops by the Brazilian Health Regulatory Agency, including soy. MRLs for soybeans in Brazil are set 
in 0,3  mg/kg. Around 11% of the soy produced in Brazil is exported to the EU. Therefore, restrictions 
on mancozeb would significantly impact the income of Brazilian farmers. This is the reason why we 
have warned European delegates about the relevance of mancozeb in past bilateral meetings and 
tried to receive more information regarding the review process. However, the EU informed that 
before th e notification publication no comments would be taken into consideration. Therefore, we 
kindly ask the EU to indicate the early appropriate stage of the development of the technical 
regulation in which countries could present comments that EU would effecti vely take into 
consideration. Brazil remembers the TBT Agreement in Article 2 states the following: "Whenever a 
relevant international standard does not exist or the technical content of a proposed technical 
regulation is not in accordance with the technic al content of relevant international standards, and if 
the technical regulation may have a significant effect on trade of other Members, Members shall: 
publish a notice in a publication at an early appropriate stage, in such a manner as to enable 
intereste d parties in other Members to become acquainted with it, that they propose to introduce a 
particular technical regulation; without discrimination, allow reasonable time for other Members to 
make comments in writing, discuss these comments upon request, and  take these written comments 
and the results of these discussions into account. " 
1.38.   The availability of an alternative to mancozeb in the short and medium term is also limited by 
the fact that other substances of similar use have already been banned in the Eu ropean market, 
such as chlorothalonil. Mancozeb is an important tool for the management of fungicide resistance to 
control soybean rust, one of the most devastating diseases for this crop. It is used as a crop 
protection additive, intended to increase the effectiveness of other fungicides, minimizing resistance 
and prolonging the life cycle of other molecules, which would otherwise have an extremely short life 
cycle. Also, such crops cannot have their treatments changed in time for exportation to the EU 
market before late 2020. We also urge European authorities to consider establishing transition 
periods that are adequate to the production cycle of the affected crops. By refraining from changing 
its approach regarding assessment of endocrine disruptors, the EU will keep on imposing measures 
related to active substances that are more trade  restrictive than necessary to achieve its legitimate 
objectives under the TBT Agreement. The implementation of regulations with serious impacts on 
trade prior to a thorough risk analysis raises concerns about discrimination, transparency and due 
scientific evaluation. The Brazilian delegation was informed that the EU used as a basis for the non -
renewal of mancozeb a study from 1980 and, considering that more recent studies ar e available, we 
would like to hear from the EU delegation if that information is accurate and up to date.  
1.39.   In summary, Brazil kindly asks EU delegations to point out the following: (i) what are the 
most recent studies and assessments used for the re -evaluat ion of mancozeb? (ii) does the EU 
consider that the notification was made at an early stage in order to take other Members ' views into 
consideration? (iii) what other less trade -restrictive alternatives were considered in the development 
of said draft regu lation?  
1.40.   The delegation of Costa Rica  provided the following statement. Costa Rica supports the  
concern raised by Colombia, Brazil, Ecuador and the United States in relation to the draft G/TBT/M/81  
 
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  implementing regulation notified  by the European Union, under which approval for the use of 
mancozeb would not be renewed.  The use of this active substance is essen tial for Costa Rica's 
agricultural production process. Mancozeb is currently used for more than 20 crops that are grown 
for export and domestic consumption, and is therefore vital for ensuring the supply of food.  The 
COVID -19 pandemic faced by the world in  recent months has maximized the need to avoid the 
application of measures that could affect food suppl ies, particularly when such measures constitute 
restrictions that could conflict with multilateral obligations.  
1.41.   In Costa Rica there are currently no auth orized phytosanitary protection products that could 
be considered substitutes of, or that are similar to, mancozeb, which is used to combat pests of 
economic importance, particularly in banana production. Costa Rica is the world's second largest 
exporter o f bananas, and the first country to have obtained a geographical indication for this product.  
Foreign exchange revenue from banana exports totalled approximately USD 1 billion , representing 
around 2% of GDP and 38.6% of agricultural GDP . The banana sector  also generates 40,000 direct 
jobs and around 100,000 indirect jobs. The main destination for exports is the European Union, 
where over 50% of the fruit produced in Costa Rica is sent, which further illustrates the impact that 
would be generated by the ban on the use of m ancozeb and the subsequent reduction in maximum 
residue levels (MRLs) for this substance in bananas . The Costa Rican banana sector is currently 
assessing, in conjunction with the competent authorities, products that might be used as alternat ives 
to mancozeb . However, time is needed to complete the relevant tests and approval procedures .  
1.42.   Costa Rica recognizes that Members have t he right to determine the appropriate level of 
sanitary or phytosanitary protection needed  to protect human, animal or plant life or health,  and to 
establish measures to that end; in turn, may we remind Members that these measures must be 
science -based and should not create unnecessary barriers to trade, especially in these times of 
economic recovery faced by the global  market in light of the current pandemic . Costa Rica requests 
that the EU postpone the non -renewal process and subsequent reduction of MRLs for mancozeb, so 
as to give the national sanitary and phytosanitary authorities a reasonable period of time to respo nd 
to the numerous challenges posed by the COVID -19 pandemic and find an alternative substance so 
that Costa Rican farmers can continue to grow bananas and meet the demand of EU countries . 
1.43.   The delegation of the United States  provided the following statemen t. The United States 
thanks Brazil, Colombia, and Guatemala for raising this concern. The European Union's approach to 
pesticide regulation, which has led to the April 2020 Draft Commission Implementing Regulation 
concerning the non -renewal of the approval  of mancozeb, remains a continual concern. The United 
States is concerned the EU continues to ignore international standards and fails to provide adequate 
rationale of the risk of non -fulfilment to justify the non -renewal of substances. Mancozeb is one of 
several fungicides for which, along with its common metabolite ethylene thiourea (ETU), the United 
States has completed a rigorous risk assessment. Once that highly refined risk assessment was 
completed, the United States established maximum residue limits  (MRLs) for the use of mancozeb 
following its registration renewal in 2005. The substance is currently under re -evaluation. Codex 
Alimentarius has also established MRLs for mancozeb on many food crops based on full risk 
assessment and review of good agricu ltural practices, which facilitate trade while protecting 
consumer health. As repeated in prior WTO interventions on the EU's hazard cut -off criteria for 
possible endocrine disruptors, the United States is concerned that non -renewal  due to hazard 
potential  creates excessive uncertainty for agricultural trade.  
1.44.   The EU regularly suspends its risk assessments following identification of hazard criteria or 
data gaps. It has not finalized its consumer risk assessment of mancozeb. Mancozeb is used to 
protect many  fruit, vegetable, nut and field crops against a wide spectrum of diseases, including 
potato blight, leaf spot, scab and rust. It is also used for seed treatment of cotton, potatoes, corn, 
safflower, sorghum, peanuts, tomatoes, flax and cereal grains. Many  of these crops cannot have 
their treatments changed such that they can be harvested and shipped to the EU market before the 
third quarter of 2020. Others have few or no other options available and could suffer crop losses 
without access to mancozeb. The U nited States exported more than USD 3.3 billion in fruits, 
vegetables, and tree nuts to the EU in 2019. The trade loss resulting from any one MRL can be 
difficult to measure; however, the EU's systemic removal of MRLs for important crop protection tools 
increases costs and creates uncertainty for growers and traders, which damages trade. The United 
States asks the EU to maintain its current mancozeb MRLs while it completes a consumer health risk 
assessment. If MRLs are lowered, the United States requests th at the EU establish transitional 
measures that allow all foods, including those with long shelf lives, to go through the complete 
channels of trade before enforcement. The United States will be submitting comments to the WTO G/TBT/M/81  
 
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  regarding the non -renewal  of approval of mancozeb and requests the EU consider the comments 
and these interventions fully before making any decision on the final regulation. The United States 
looks forward to the EU's responses, in advance of the closing of the WTO comment period on 
16 June, on the additional clarification for the non -renewal, and when the EU will finalize its 
consumer risk assessment.  
1.45.   The delegation of Ecuador  provided the following statement. Ecuador wishes to express its  
concern regarding notification G/TBT/N/EU/712  on the non -renewal of the app roval of the active 
substance mancozeb . This substance is crucial for the management of various crops of export 
significance to our country that are also important to European consumers, such as bananas, cocoa, 
broccoli, dragon fruit, pineapples and roses . For Ecuador, it is vital that studies concerning the 
renewal of active substances be based on scientific evidence showing conclusive results and not on 
the precautionary principle . We refer to Article 2.2 of the WTO TBT Agreement, which states that 
"Membe rs shall ensure that technical regulations are not prepared, adopted or applied with a view 
to or with the effect of creating unnecessary obstacles to international trade. For this purpose, 
technical regulations shall not be more trade -restrictive than nec essary to fulfil a legitimate 
objective, taking account of the risks non -fulfilment would create. […] In assessing such risks, 
relevant elements of consideration are, inter alia : available scientific and technical information, 
related processing technology or intended end -uses of products ". Ecuador therefore urges the EU to 
take into consideration the relevant scientific information emanating from international specialized 
agencies recognised by the WTO, such as the Codex Alimentarius, which has i nformation relating to 
this substance, especially since, according to the EFSA risk analysis summary, the consumer risk 
assessment has not been completed . 
1.46.   In the study presented by the EU in the draft notification, Ecuador verified that the analysis 
was ca rried out specifically for tomatoes, potatoes, wheat and grapes . While this notification 
currently only mentions the marketing of this substance in the European Union, and not maximum 
residue levels (MRLs) for mancozeb, Ecuador takes this opportunity to ur ge the EU to review its 
decision to reduce all MRLs for mancozeb to the limit of detection. The MRL for this substance should 
be determined on a product -by-product basis, given that agricultural production varies according to 
region, and what works in Euro pe might not be appropriate in other climates and regions . 
Furthermore, for certain crops treated with mancozeb that are currently exported, there might not 
be any effective pest -control alternative, and this would heavily impact Ecuador's agricultural 
exports, which are already affected by the world health situation  (COVID -19). Ecuador therefore 
joins calls for the EU to base its measures on conclusive studies, to refrain from introducing definitive 
measures on the basis of the precautionary principle, and  to establish transition periods of at least 
36 months for the registration of alternative substances, in view of the current shortage of tools 
available to control pests.  
1.47.   The delegation of Paraguay  provided the following statement. The delegation of Parag uay 
would like to thank the delegations of Colombia, Brazil, Costa Rica, the United States and Ecuador 
for including this concern on the agenda. Mancozeb is an active substance in use for over 50 years 
and is still considered an important tool for controll ing phytopathogenic fungi worldwide, especially 
as part of resistance -combating programmes.  Mancozeb is a multisite, protective fungicide used on 
more than 70 crops such as vegetables, fruit trees, ornamentals, nuts, cereals, soya beans, maize, 
potatoes, b ananas, citrus fruit, grapes and turf. The substance is used to treat more than 400 
diseases, alone or blended with systemic fungicides, of species belonging to the four major fungi 
groups: PHYCOMYCETES, ASCOMYCETES, DEUTEROMYCETES, BASIDIOMYCETES; Phytoph thora, 
Botrytis, Alternaria, Michosphaerella, Septoria, Peronospora, Phoma, Pseudoperonospora, 
Cercospora, Venturia, Plasmopara, Monilia, Anthracnose, Puccinias, Uromyces, Ascochyta, 
Helminthosporium, Sphaceloma, Uncinula, Diplocarpon . It has become a stra tegic fungicide used to 
control the 10 major diseases worldwide, with more than a 95 % usage rate.  
1.48.   Paraguayan producers currently use mancozeb to control soybean rust which, due to 
resistance, cannot be tackled using other fungicides currently on the market . Given its multisite 
usage, mancozeb acts in various environments within the pathogenic organism that has become 
resistant to other fungicides. Consequently, withdrawing this product from circulation could 
potentially increase the use of other fungicides during the productive cycles, while simultaneously 
reducing their efficiency. This would hit the production output of a crop that is a mainstay of the 
Paraguayan economy.  There are very few multisite products like mancozeb. One such product is 
chlorothalon il, which is equally subject to a trade concern since the European Union (EU) is also 
phasing out its use. Mancozeb and chlorothalonil account for almost 90 % of multisite use in G/TBT/M/81  
 
- 14 - 
 
  Paraguay.  Besides soya bean crops, maize crops will be affected by this non -renewal, as mancozeb 
is used on maize to combat a disease caused by Phaeosphaeria maydis . This substance is currently 
the only commonly -used and effective alternative, offering producers a good price -quality ratio.  
1.49.   Over the last decade regulatory authorities  in several regions have reassessed mancozeb as 
a current active ingredient. Based on an extensive database, studies and regulatory guidelines on 
health and the environment, mancozeb has successfully completed the regulatory reassessment. In 
the last few y ears, products containing it have been re -registered in a number of countries, including 
in the EU.  When used in compliance with good agricultural practices that do not endanger human 
health or the environment, mancozeb is a substance with low environmenta l persistence, low levels 
of acute toxicity in mammals and little or no phytotoxicity.  Any reduction in mancozeb's maximum 
residue levels (MRLs) could have a significant impact on world trade, adversely affecting third 
country producers' market access.  
1.50.   As a landlocked developing country, the impact on Paraguay could be strong, affecting farmers 
and lessening or ending access to the European market. The negative impacts would be felt directly 
by agricultural producers and indirectly by those involved in the entire production and export chain 
of agricultural products, including in transport and logistics. Moreover, without an alternative product 
on the market to control the phytopathogen, food safety could be affected should Paraguay wish to 
export to one of i ts main trading partners.  We therefore urge the EU to:  (i) set measures supported 
by conclusive risk assessments based on criteria established by international standards and 
recommendations, in accordance with the provisions of the SPS and TBT  Agreements ; and (ii) 
maintain the EU's existing MRLs for mancozeb and do not set more restrictive levels, particularly in 
the aftermath of COVID -19, in acknowledgement of the issues raised in communications 
G/SPS/GEN/1778  and G/TBT/GEN/296 . We recall that, f or Paraguay, agriculture is crucial and a 
well-functioning agricultural sector is key to ensuring food security, agricultural producers being one 
of the main sources of domestic food and income, who rely on the availability of tools like mancozeb 
to effect ively combat attacks by pests.  
1.51.   The delegation of Guatemala  provided the following statement. We thank Colombia, Brazil,  
the United States and Costa Rica for including this trade concern on the agenda.  Guatemala shares  
the concern regarding the absence  of information on the scientific evidence of harm to human health 
caused by the  consumption of fruit and vegetables, particularly those produced in Latin America.  
The European Union has previously mentioned that it has identified potentially negative effects o n 
health. The EU has failed to  provide  countries affected with information on the contamination of 
products that ha ve been assessed  with the scientific information available. Moreover, the EU has not 
present ed any scientific evidence of the supposed danger  and harm ful nature  of mancozeb in the 
production and exportation of fruit and vegetables in Latin America.  The EU has notified the TBT 
Committee of the non -renewal of the  approval of the  active substance mancozeb . This will lead to a 
subsequent revision of the current permitted MRLs, which will have a direct impact on agricultural 
exports to the EU.  Mancozeb is key for the production of a number of strategic agricultural crops 
that are exported to the EU, such as fruit (banana s and plantain s, among others)  and vegetables, 
which would affect other countries in Latin America.  
1.52.   In terms of other types of agrochemicals, there are very few  alternatives with multi-site 
properties available for the control of fung i. Mancozeb, as a multi -site fungicide, attacks diff erent 
parts of the fungus and create s no resistance. In the case of plantains and bananas, mancozeb is 
essential given the absence of  alternatives offer ing the same effectiveness.  Black Sigatoka is caused 
by the fungus Mycosphaerella fijiensis , which invades and necrotizes the leaf tissue, causing leaf 
death in  perennial banana and plantain crops. Black Sigatoka is the disease that has the greatest 
economic impact on banana and plan tain crops worldwide and can only be successfully controlled 
with mancozeb.  The ban on the use of mancozeb will have an economic and social impact on 
Guatemala, given that both plantain and banana crops are a significant source of job creation , foreign 
exchange and food for the country. The growth of these crops creates over 280,000 direct and 
indirect jobs  and therefore  affect s over 1,12 0,000 Guatemalans.  Banana exports accounted for 30% 
of Guatemala's total exports of traditional products in 2018 and 11.2 % of total exports  from the 
customs territory . The banana is the world's most consumed and exported fruit  and, as a result, 
there has been a significant rise in the foreign exchange generated by this crop . Such earnings have 
been on the increase since 2018 , ranging from USD 800 million to USD 1 billion.  
1.53.   In light of the above, we request the EU to maintain the current MRLs for mancozeb so as to 
avoid affecting  the production and exports of Guatemala and other Latin American countries, G/TBT/M/81  
 
- 15 - 
 
  particularly given the economic and social impact that this type of measure will have on developing 
countries.  
1.54.   The delegation of Indonesia  provided the following statement. Indonesia thanks Colombia, 
Brazil, Costa Rica, the United States, and Ecuador for raising this issue and s hares the concern 
regarding EU regulation on non -renewal of the approval of the active substance mancozeb. Indonesia 
understands that the EU has considered the safety and health aspect of environmental whil e 
developing the Draft Commission Implementing Reg ulation concerning the non -renewal of the 
approval of the active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council concerning the placing of plant protection products on 
the market, and amendi ng the Annex to Commission Implementing Regulation (EU) No 540/2011. 
However, Indonesia is of the view that this measure is more stringent than necessary and has the 
potential to disrupt trade, specifically for developing countries who export horticulture and other 
agriculture products to the EU. Indonesia regrets the application of this measure and, therefore, 
urges the EU to ensure that this measure is not more stringent than necessary. In addition, Indonesia 
would also like to remind the EU to use the ri sk assessment approach that is internationally accepted 
based on appropriate data and scientific study. In developing this measure, EU only refers to risk 
assessment conducted by E uropean Food Safety Authority (EFSA) , which are clearly not in line with 
the recommendation of the FAO Manual on the development and use of FAO and WHO Specifications 
for Plant Protection Products, FAO Plant Production and Protection Paper No. 173, Rome 2002. In 
this paper, FAO acknowledges the use of mancozeb as the active substa nce for plant protection 
product. Indonesia, thus, requests the EU to review its policy regarding the non -renewal of the 
approval for mancozeb and to allow the use of mancozeb as active substances for plant protection 
product.  
1.55.   The delegation of Nicaragua  provided the following statement. The delegation of Nicaragua 
thanks the delegations of Brazil, Colombia, Costa Rica and the United States for including this 
concern on the agenda. This concern relates to the European Union notification contained in 
documen t G/TBT/N/EU/712 , in which i t notifies the non -renewal of the approval of the substance 
mancozeb. The active substance or compound mancozeb is a pesticide used extensively in 
agriculture. It belongs to the dithiocarbamates chemical group and is currently used to combat Black 
Sigatoka  disease in musaceae. Black Sigatoka is a leaf disease of bananas, which is caused by the 
ascomycete fungus Mycosphaerella fijiensis  Morelet and constitutes one of the crop's main 
phytopathological problems. The delegation of Nicaragua reiterates that the policy implemented by 
the EU concerning the approval of certain substances and the modification of MRLs could have a 
significant impact on trade in food and the agricultural economy in developing and least developed 
countries. While Nicaragua respects the rights of each Member to determine the appropriate level of 
protection, we reaffirm that Members' efforts should, as far as possible, be harmonized with the 
relevant international provisions.  
1.56.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks WTO Members for raising this issue. On 17 April 2020, the European Union  
notified to the TBT Committee a draft Commission Implementing Regulation concerning the non -
renewal of the approval of the  active substance mancozeb, in accordance with Regulation (EC) No 
1107/2009 on the placing of plant protection products on the market. Existing authori zations of plant 
protection products containing mancozeb will be withdrawn and such products cannot be pl aced into 
the market. The non -renewal of the approval is based on a scientific assessment conducted under 
Regulation (EC) No 1107/2009 by experts from the member States of the European Union and the 
EFSA. In order for an active substance to be approved in accordance with Regulation (EC) No 
1107/2009, it must be demonstrated that the substance is not harmful to human health, animal 
health or the environment. Specific criteria, listed in Article 4 of the Regulation (and further detailed 
in Annex II), must be met to enable approval. During the evaluation and peer  review of mancozeb, 
the following concerns were identified by EFSA . A reprotoxic potential of mancozeb, classified as 
Toxic for reproduction category 1B in accordance with the criteria set out in Commi ssion Regulation 
(EC) No 1272/2008. The non -dietary exposure estimates exceed the reference values for tomatoes, 
potatoes, cereals and grapevines. Moreover, endocrine disruptors criteria are met for humans and 
likely for non -target species. In light of the  above, EFSA concluded that mancozeb does not meet 
the approval criteria as outlined in Article 4 of Regulation (EC) No 1107/2009 and cannot be currently 
approved. EU member States must withdraw existing authori zations for plant protection products 
contain ing mancozeb at the latest by three  months from the date of entry into force of the 
Commission Implementing Regulation. The grace period in line with Article 46 of Regulation 
1107/2009 shall expire, at the latest, after six months from the entry into force  of the Implementing G/TBT/M/81  
 
- 16 - 
 
  Regulation. This decision only concerns the placing on the market of mancozeb and plant protection 
products containing it. Following non -approval and the expiry of all grace periods for stocks of 
products containing this substance, sep arate action will likely be taken on Maximum Residue Levels 
(MRLs) and a separate notification will be made in accordance with SPS procedures.  
1.2.9   European Union – Draft Commission Regulation amending Annex III to Regulation 
(EC) No 1925/2006 of the European P arliament and of the Council as regards botanical 
species containing hydroxyanthracene derivatives, G/TBT/N/EU/702  (IMS ID 62810) 
1.57.   The delegation of Mexico  provided the following statement. The delegation of Mexico is  
submitting this concern relating to the Draft Commission Regulation amending Annex III to 
Regulation (EC) No.  1925/2006 as regards botanical species containing hydroxyanthracene 
derivatives, of which the Members of the TBT Committee were notified in document 
G/TBT/N/EU/702 . The Government of Mexico is sending its comments on this draft regulation on 
2 May 2020 within the framework of the WTO public consultation process.  The delegation of Mexico 
recognizes the interest of the EU in establishing public health protection measures. However, it 
considers that the draft regulation may unnecessarily restrict trade in view of the legitimate objective 
pursued. Given that the draft  regulation would impose an absolute ban on the use of aloe and its 
extracts in food and beverage formulas, its implementation would adversely impact the Mexican 
industry that produces and exports to the European Union a variety of products for human 
consu mption containing aloin, a component naturally found in aloe vera.  
1.58.   It is considered that the draft regulation could violate the principle of proportionality 
(Article  2.2) and conformity with international standards (Article 2.4), and not allowing a reasona ble 
interval for the measure's entry into force (Article 2.12) of the WTO's TBT Agreement. These 
considerations are based on the following . The proposed amendments are based on a scientific 
opinion issued by the European Food Safety Authority (EFSA) on 22  November  2017, about which 
we should like to make the following comments . The EFSA's opinion does not differentiate between 
whole leaf preparations and aloe vera extracts which may contain minimum levels of 
hydroxyanthracene derivatives (HAD). In its risk assessment, the EFSA's scientific opinion does not 
include measures on the potential effects of other types of aloe containing minimum or zero levels 
of HAD for use in food products and preparations. The EFSA does not provide advice on a daily aloe 
intake that does not give rise to concerns about harmful effects to health, aside from improving 
bowel function. The EFSA's conclusions are based on studies performed on rats, rather than on 
humans. It is even recognized in those conclusions that the possible eff ects of aloe vera and its 
extracts on human health remain uncertain and that it would be inappropriate, therefore, to 
implement an absolute ban on consumption of the substance.  Neither the EFSA's opinion nor the 
documents shared with notification G/TBT/N/EU/702  indicate whether any i nternational standards 
were used as a reference for the proposed amendments. Yet the Codex General Standard for Food 
Additives (GSFA, CODEX -STAN -1995 (2019) ) recogni zes aloe vera as an additive that can be used 
under specific conditions for certain food ca tegories or certain food products.  The draft regulation 
was not notified as an urgent technical regulation. Therefore, the provisions of Article 2.12 of the 
TBT Agreement and Article 5.2 of the Ministerial Declaration adopted by the WTO Members on 
20 Novem ber 200111 relating to the reasonable interval for the entry into force of technical 
regulations must not be neglected.  
1.59.   The delegation of Mexico therefore respectfully submits the following requests to the 
delegation of the EU:  reconsider the proposed amend ment to Part A of Annex III of Regulation (EC) 
No. 1925/2006, on the basis of existing scientific evidence on the use of aloe vera or its extracts in 
consumer products, which does not reveal a threat to public health that would warrant a ban on 
these subst ances ; clarify whether the draft regulation also covers aloin naturally contained in food 
products ; align the draft regulation with the provisions of CODEX -STAN -1995 (2019), or explain why 
the European Commission is promoting the adoption of a measure that  deviates from this standard ; 
set a reasonable interval for the entry into force of the draft regulation ; and r eview and take into 
consideration the comments sent by Mexico on 2  May 2020 during the public consultation process.  
The delegation of Mexico than ks the delegation of the EU for giving consideration to this statement 
and the requests therein.  
 
10 For previous statements follow the thread under IMS ID  628 (under dates raised and references) . 
11 Ministerial Declaration of 20 November 2001, available at: 
https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.htm . G/TBT/M/81  
 
- 17 - 
 
  1.60.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks Mexico for raising this issue. The proposed draft  measure is based on the 
scientific advice of the E FSA and on extensive consultations with member States and all interested 
parties. The draft measure aims to ensure a high level of safety, as well as proportionality, by 
prohibiting the use in foods of the  substances whose harmful effect on health has been established, 
while placing under Union scrutiny the substances for which scientific uncertainties remain according 
to the EFSA opinion. Under the scrutiny period, interested parties will have the possibil ity to submit 
data demonstrating the genuine safety of the substances in question. In the scientific opinion of 
EFSA of 22 November 2017, certain hydroxyanthracene derivatives – HADs – (such as emodin, aloe -
emodin and danthron) and aloe extracts containing  HADs were found to be genotoxic and/or 
carcinogenic based on the data obtained from in vitro  and in vivo  clinical studies. The EFSA Panel 
further considered that there is a safety concern for certain extracts containing HADs (such as 
Rheum, Cassia and Rha mnus extracts), although scientific uncertainty persists. Considering that the 
EFSA Panel noted that there was some evidence of genotoxic effects of aloe extracts depleted of 
HADs, and that it could not advi se on a daily intake of HADs that does not give r ise to concerns for 
human health, no safety limit could be set in the measure to distinguish between the different aloe 
preparations with a range of HAD levels.  
1.61.   The proposed measure is in accordance with the procedure under Article 8 of Regulation (EC) 
No 1925/2006 on the addition of vitamins and minerals and of certain other substances to food. The 
mentioned procedure allows the Commission to prohibit, restrict or place under Union scrutiny the 
use of a substance other than vitamins or minerals in foods, o r of an ingredient containing it, if that 
substance is associated with a potential risk to consumers. Article 2 of the Regulation defines a 
substance other than a vitamin or a mineral as a substance that has a nutritional or physiological 
effect. The draft  measure is therefore applicable to the substances when added to food for nutritional 
or physiological purposes without regulating other possible uses, such as the addition of the 
substances for technological purposes as food additives. Besides the TBT not ification, the draft 
measure was published for a seven -week consultation period to ensure the possibility of providing 
feedback to all interested parties. During that consultation, a number of comments were submitted 
by different stakeholders, such as busi ness associations, companies, NGOs, academic and research 
institutions, as well as citizens. The European Commission is currently analysing all the comments 
received and will consider possible amendments to the draft measure in order to ensure that the 
most appropriate risk management decision is taken on this matter.  
1.2.10   New Zealand – Consumer Information Standards (Origin of Food) Regulations 
2019, G/TBT/N/NZL/93  (IMS ID 62912) 
1.62.   The delegation of Canada  provided the following statement. Canada would like to thank New 
Zealand for its bilateral engagement on this issue and for providing preliminary responses to 
Canada's comments submitted on 7 February and 20 March through New Zeala nd's Enquiry Point. 
Canada acknowledges New Zealand's legislative requirement to establish a consumer information 
standard for the disclosure of a regulated food's country or place of origin. We also recognize New 
Zealand's objective to provide consumers w ith accurate country -of-origin information for certain 
single -ingredient, minimally processed foods. However, Canada is concerned with the proposed 
requirements for meat and cured pork that require labels to contain information on where the animal 
was rais ed. Given the highly integrated nature of the North American supply chain for meat and 
livestock, producers and slaughterhouses would need to implement costly segregation and 
traceability measures throughout the production chain in order to comply with New  Zealand's 
proposed labelling requirements. Canada's experience with similar measures imposed by another 
WTO Member in the recent past is well  known. In fact, Canada was successful in demonstrating that 
this measure resulted in the discriminatory treatment  of trade from Canada and was in violation of 
international trade obligations.  
1.63.   Canada respectfully requests that New Zealand consider using relevant international 
standards, such as the Codex Standard for the Labelling of Prepackaged Foods (CODEX STAN 1 -
1985) for its proposed COOL requirements for meat products. This standard states that "[w]hen a 
food undergoes processing in a second country which changes its nature, the country in which the 
processing is performed shall be considered to be the country of origin for the purposes of labelling ". 
Doing so would meet the objective of providing consumers with accurate and useful information 
pertaining to the food they purchase without requiring unnecessary restrictive traceability or 
 
12 For previou s statements follow the thread under IMS ID  629 (under dates raised and references) . G/TBT/M/81  
 
- 18 - 
 
  segregation measures that im pact trade. We remain open and willing to continue our engagement 
with New Zealand.  
1.64.   In response, the delegation of New Zealand  provided the following statement. The Consumer 
Information Standards (Origin of Food) Regulations will prescribe requirements for  the disclosure of 
where a regulated food was grown, harvested, caught or raised, rather than where the food was 
merely packaged, manufactured or processed. Due to COVID -19, the regulations will be made by 
June 2021, instead of June 2020. We note in partic ular that where it is challenging to trace the 
supply chain of a product, the regulations allow for multiple relevant countries to be included on the 
label to indicate the country of origin. In drafting the Regulations, New Zealand took steps to ensure 
their consistency with WTO TBT Agreement obligations. New Zealand also considered all comments 
received during the open consultation period, including those received in response to the 2018 TBT 
notification G/TBT/N/NZL/84 . New Zealand notes that the regulations will be non -discriminator y. 
They will apply to both domestic and imported products equally. New Zealand thanks Canada for its 
comments and remains open to further discussion on this matter if necessary.  
1.2.11   India – Quality Control Orders for Chemical and Petrochemical Substances, 
G/TBT/N/IND/116 , G/TBT/N/IND/122 , G/TBT/N/IND/124  (IMS ID 63013) 
1.65.   The delegation of Canada  provided the following statement. Canada welcomes this 
opportunity to discuss a series of 22 individual "Quality Control Orders " on chemicals and 
petrochemicals substances notified by India since November 2019. These prospective measures 
would make mandatory the use of Indian Standards on the notified substances. Canada submitted 
its initial comments on these prospective measures on 31 March 2020 and would like to seize this 
opportunity to highlight some of its concerns with regards to the various no tifications. Firstly, Canada 
requests additional explanations from India on the rationale for enforcing mandatory Indian 
Standards on those chemicals and petrochemicals substances. Canada noted that each of the 22 
notifications published by India did not c ontain any justifications for the new measures, except that 
"the Central Government […] is of the opinion that it is necessary or expedient so to do in the public 
interest ". Can India elaborate on the necessity for these mandatory Bureau of India Standards  to 
safeguard public interest, and why international standards or other type of voluntary standards were 
deemed not sufficient to achieve the same objectives? Secondly, Canada is concerned with India's 
approach to these notifications, and would request cla rifications as to why India notified these new 
standards individually and without supporting documentation that would clarify the stated objective 
of the proposals, i.e., to ensure "health, safety and environment for prevention of deceptive practices 
and n ational safety ", and how these new regulatory requirements are not more trade restrictive than 
necessary to achieve this objective. What process, research, and assessment has India performed 
on these substances to arrive at this conclusion? Can India share  those documents with WTO 
Members? What are the risks to health, safety, environment, and – specifically – "national safety "? 
1.66.   Thirdly, Canadian stakeholders are concerned that these new measures could seriously 
undermine the ability of foreign chemical man ufacturers to access the Indian market. The new permit 
requirements will add a significant level of bureaucracy for both industry and Indian regulators and 
could reasonably result in significant delays in the import process. Moreover, Canada understands 
that the certification period will be limited to one year, which would accentuate the pressure on the 
administrative body to review, deliver and/or renew new permits on a constant basis. What steps 
has India taken to ensure the capacity of its administrative  authorities to effectively implement the 
new measures and deliver the new permits in a timely manner? Has India considered extending the 
certification period beyond one year? Fourthly, could India confirm if it will accept quality control 
assessments cond ucted by foreign firms and laboratories? If third -party assessment will not be 
accepted, Canada would request that a rationale be provided on this decision. Finally, Canada would 
request clarifications on how the new mandatory standards will be enforced fo r: (i) domestic 
manufacturers; and (ii) foreign producers and importers. Specifically, Canada would seek 
clarifications on the steps taken by India to ensure that the new measures will not discriminate 
foreign products to the benefit of domestic manufactur ers. As all 22 notifications provided limited 
information on the process and rationale for the new measure, Canada looks forward to further 
engaging with India on this issue in order to ensure transparency, avoid unnecessary impacts to 
trade, and better un derstand the objectives sought by India. Canada would also request that the 
entry into force of the new mandatory standards be delayed until further clarifications have been 
 
13 For previous statements follow the thread under IMS ID  630 (under dates raised and references) . G/TBT/M/81  
 
- 19 - 
 
  provided to all interested parties. Canada also look forward to receiving written answers from India 
on the letter of comments it sent on 31 March 2020.  
1.67.   The delegation of the European Union  provided the following statement. The European Union 
has concerns on these draft regulations. We sent written comments to India on G/TBT/N/IND/116  
in February 2020 and on G/TBT/N/IND/12 2 in April 2020 and are looking forward to receiving written 
replies before the adoption of the notified drafts. The EU understands that the authorities of India 
are proposing to make 72 chemical/ petrochemical standards from the Bureau of Indian Standards  
(BIS) mandatory by introducing a permitting system and that the two notified drafts are part of this 
legislative package. The EU would like to remind the authorities of India that in accordance with the 
TBT Agreement, standards are considered voluntary, w hereas mandatory standards are considered 
as technical regulations. The EU would be grateful if the above -mentioned comments could be taken 
into account and replied to before adoption of the notified draft.  
1.68.   The delegation of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to thank India for providing the opportunity to comment on the draft Orders 
concerning mandatory requirement s for chemical and petrochemical substances, which basically 
involve the bearing of the Standard Mark under a licence from the B IS. We sent our comments on 
the measure notified by G/TBT/N/IND/124  regarding Terephthalic Acid on 31 March 2020. As the 
information currently available i s insufficient to allow Members to assess the relevant impact, we 
asked India to clarify the following. Firstly, t he practices of requiring a chemical substance, such as 
Terephthalic Acid, to be certified by a product safety scheme, such as Standard Mark o f BIS, are 
unusual in international practices. We ask India to provide further explanation about the reasons 
and purposes for introducing the new regulation, namely requiring Terephthalic Acid to be subject 
to mandatory inspection, and whether relevant int ernational standards are adopted. Secondly,  we 
look forward to the publishing of further information on relevant laws or regulations to implement 
this draft Order by India as soon as possible, including the testing and inspection procedure, the 
timeframe  required to complete testing and inspection, and acceptance of test reports issued by 
laboratories outside India. Given the technical complexity of the issues involved, a separate 60 -day 
comment period should be provided after revealing further information.  We also call for India to take 
note and observe the principles of national treatment (NT) and necessity as provided for in the TBT 
Agreement when developing such regulations.  
1.69.   Thirdly, i f no other implementing laws or regulations will be published, we woul d like to better 
understand how the Standard Mark system applied specifically to Terephthalic Acid. Again, answers 
to the questions concerning testing and inspection procedure, the time frame , acceptance of test or 
inspection reports, are needed for assessi ng the impact. Fourthly,  where test reports from testing 
laboratories are not accepted, we call for India to consider providing opportunities for testing 
laboratories and relevant inspection bodies from other WTO Members to participate in the intended 
conformity assessment process with the view of reducing the impact. Due to the potential impact 
that is likely to occur, we urge India to observe the spirit of the notification mechanism and refrain 
from enacting the new regulation before WTO Members can fully  assess the impact and express their 
comments. We would be grateful if the above -mentioned comments could be taken into account and 
replied to before adoption of the notified draft.  
1.70.   In response, the delegation of India provided the following statement. Ind ia welcomes the 
comments made by the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu, Canada 
and the European Union on India's Quality Control Orders for Chemical and Petrochemical 
Substances. India would like to inform the Members that the said regulation has been notified 
keeping in view the health, safety and environment and for prevention of deceptive practices. As 
mentioned in the notification, Indian standard 15030:2001 has been proposed for adoption. On the 
procedure, testing requireme nts, guidelines for issuance of licence , etc., Members are informed that 
the conformity assessment requirements will be governed as per Scheme -I of Schedule -II of BIS 
(Conformity Assessment ) Regulations, 2018 that have been notified with regulation to the  WTO 
(G/TBT/N/IND/124) . In this regard, Members may refer to the standard IS 15030:2001 mentioned G/TBT/M/81  
 
- 20 - 
 
  in the Regulation. Such information is also available in the public domain and can be accessed from 
the B IS website at the following weblinks.14  
1.71.   Hence, as of now, India does not envi sage issuance of any additional notification to WTO, 
laying down any separate conformity assessment requirements. On the feasibility of allowing 
extension of the date of entry into force of the measure, India considers that sufficient time period 
has been provided for Members to comment upon the new measure and there will not be need for 
any further extension for its implementation. Similarly, the certification period has been prescribed 
in the BIS (Conformity Assessment) Regulations, 2018 and would not be feasible to change. Further, 
Members are informed that the BIS is the certifying body for the purpose of conformity assessment 
of the product mentioned in the aforesaid draft Quality Control Order. Under the provisions of 
Scheme -I of Schedule -II of BIS (Co nformity Assessment) Regulations, 2018, the testing of samples 
drawn during the factory inspection is carried out in third -party laboratory. It has been stated therein 
that the "Third party laboratory " is "a laboratory established, maintained or recognized  by the Bureau 
or Government laboratories empanelled by the Bureau or any other laboratory decided by the 
Executive Committee of the Bureau ". On the use of the national standard i.e., the BIS standard 
instead of relying on international standard for the pu rpose, it is informed that because there is no 
ISO standard available on the subject , IS 15030 and the said standard has thus been formulated 
taking into account the inputs from the relevant Indian stakeholders. On the concerns raised on the 
possible discr iminatory treatment to foreign products under the measure, it is informed that the new 
measure does not envisage the same and will not discriminate foreign products to the benefit of 
domestic manufacturers. India will also be willing to discuss bilaterally  any other issue Members may 
have on this measure.  
1.2.12   India – Food Safety and Standards Act, 2006 dated 27 January 2020 regarding 
operationalization of Food Safety and Standards (Food Products Standards and Food 
Additives) Amendment Regulations, 2020, G/TBT/N/IND/145  (IMS ID 63115) 
1.72.   The delegation of the United States  provided the following statement. The United States is 
very concerned with India's new directive on animal feed, which went into effect on 27 January 
2020, part of which was notified to the TBT Committee as G/TBT/N/IND/145  on 27 February 2020. 
We anticipate that it will have a significant impact on trade for feed ingredients, and possibly on 
meat and dairy products derived from livestock that is fed in another country and imported into 
India. The measure of concern was published by the Food Safe ty and Standards Authority of India 
(FSSAI) in January 2020 in two parts. Part one, entitled "Direction under 16(5) of Food Safety and 
Standards Act, 2006 regarding compliance of commercial feeds/feed materials intended for food 
producing animals with the relevant BIS standards " is available on the FSSAI website.16 We note 
that FSSAI initially issued part one on 10 December 2019, and then issued a revised version on 
27 January 2020. Neither of these versions has been notified the WTO. Part two of this measur e, 
entitled "Direction under 18(2)(d) read with section 16(5) of Food Safety and Standards Act, 2006 
regarding operationali zation of Food Safety and Standards (Food Products Standards and Food 
Additives) amendment Regulations, 2020 " is also available on th e FSSAI website.17 The United 
States notes that the directive states it will come into force after six  months from the date of issuance 
on 27 January 2020. We note that this timeframe is insufficient for comments and review in addition 
to the need for expor ters to adjust to supply changes. We urge India to delay implementation of this 
 
14 For Indian Standard  (IS 15030): www.bis.gov.in  >>Standardization>>Published Standard; For BIS 
(Conformity Assessment) Regulations, 2018: www.bis.gov.in   >> About BIS >> BIS Act, Rules & Regulations 
>> The Bureau of Indian Standards (Conformity Assessment) Regulations, 2018; For Guidelines for Grant of 
License: www.bis.gov.in   >>Conformity Assessment >> Product Certification >> Certification Process.  
15 For previous statements follow the thread under IMS ID  631 (under dates raised and references) . 
16 See: 
https://fssai.gov.in/upload/advisories/2019/12/5def78627ba0eDirection_Feed_Animal_BIS_10_12_2019.pdf . 
See also:  
https://fssai.gov.in/upload/advisories/2020/01/5e313047e761aDirection_Meat_Milk_Feed_29_01_2020.pdf . 
And: 
https://www.fssai.gov.in/upload/advisories/2020/01/5e32c60fd8801Corrigendum_Direction_Meat_Milk_Feed_3
0_01_2020.pdf . 
17 
https://www.fssai.gov.in/upload/advisories/2020/01/5e31306a72882Direction_FSS_Product_Animal_Feed_29_
01_2020.pdf . 
 G/TBT/M/81  
 
- 21 - 
 
  directive until it is fully notified, and to provide the opportunity for Member countries to offer 
comprehensive feedback.  
1.73.   Part one of the measure appears to make mandatory a guidance document from 2009 
entitled, "Indian Standard, Compounded Feeds for Cattle - Specification. " According to this 2009 
document, India only allows for import of those feed types listed in the document. This list, which 
appears not to have been update d for many years, omits many commonly used feed ingredients and 
several types of essential supplemental vitamins. It is unclear whether there is a process by which 
certain types of feed can be added; we request that India document that process. We request that 
India clarify if it has consulted with its domestic feed industry when formulating this regulation. The 
United States understands that India's commercial feed industry representatives have stated that 
they cannot comply with the current regulation as amended because the regulation excludes so 
many commonly used feed ingredients. We request that India clarify if this regulation will also apply 
to domestic farms manufacturing their own feed, and, if so, how Indian regulators will monitor and 
enforce such  requirements. Turning to part two of the directive, we note that the 27 January directive 
includes language that amends requirements for meat and meat products and dairy products as 
detailed in the 2011 FSSAI Food Product Standards and Food Additives regu lations. We are 
concerned that India is and has been amending this regulation without notification to the WTO. We 
note that the last Food Additive compendium is dated 29 March 2019 and includes the text in Part 
2, notified to the WTO on 27 February 2020. W e ask that India take steps to ensure that any changes 
to its FSSAI Food Additive requirements that could impact imported products be notified to the WTO 
at an early and appropriate stage. Finally, we request that India clarify if other countries will be a ble 
to export meat to India if that meat is derived from livestock fed with feed ingredients not yet listed 
as approved ingredients for compounded cattle feeds and, if so, that India explain how it intends to 
monitor and enforce such requirements.  
1.74.   In resp onse, the delegation of India provided the following statement. India would like to 
appreciate the comments made by the United States seeking clarity on the Measure. India would 
like to inform the Members that the direction under 18(2)(d) read with section  16(5) of Food Safety 
and Standards Act, 2006 was issued by the FSSAI on 27 January 2020 vi a File No. 1 -
95/Std/Misc/SP(L&C/A)/FSSAI -2015-Pt-2 to operationalize with immediate effect the amendment in 
the Food Safety and Standards (Food Product Standards and  Food Additives) regulation, specifying 
certain requirements in respect of feed meant for meat and milk producing animals. It was duly 
notified to WTO so as to enable interested Members to become acquainted with it. The amendment 
regulations as per the dir ection vi a File No. 1 -95/Std/Misc/SP(L&C/A)/FSSAI -2015-Pt-2 dated 
27 January  2020 was notified to WTO via notification G/SPS/N/IND/249  dated 26 February 2020 
and G/TBT/N/IND/145  dated 27 February 2020. Pursuant to this amendment regulation, another 
direction was issued by FSSAI on 27 January 2020 via File N o. 1-95/Std/Misc/SP(L&C/A)/FSSAI -
2015-Pt-1, specifying the mandatory requirement for commercial feeds intended for cattle to comply 
with the B IS specifications for Compounded Feeds for Cattle (IS 2052:2009). This direction, 
superseding the earlier directio n of 10 December 2019 (which was issued in similar context) will 
come into force after six months from the date of its issuance. Hence a time period of six months 
has already been provided to all stakeholders to comply with the same. However, on request, F SSAI 
may consider the feasibility of any further extension of this time period in view of the current 
COVID -19 pandemic and its impact on the preparedness of all stakeholders including WTO Members.  
1.75.   It is further informed that IS 2052:2009 is the fourth rev ision of the standard which was 
published in 2009 and having subsequent amendments to it issued in 2010 and 2016. The standard 
is reviewed periodically. It was last reaffirmed in 2019. However, in case, the US has any specific 
inputs on the additional feed  ingredients, the US may make it available to BIS along with justification, 
for their consideration. The amendment in Food Safety and Standards (Food Product Standards and 
Food Additives) Regulations, 2011 is an enabling provision based on which orders wil l be issued from 
time to time for the compliance of feed with the relevant BIS standards, as required, based on 
consultation with the stakeholders including industries. BIS standards are developed by its Technical 
Committees with a wider membership of stak eholders. On the issue of the possibility of any 
differential treatment to imported products, Members are informed that the said measure will be 
applicable to all commercial feeds intended for cattle, whether manufactured domestically or 
imported into Indi a as envisaged in the aforesaid direction. Moreover, so far as compounded feeds 
are concerned, the said direction is in the context of feed for food producing animals and shall be 
specifically applicable to commercial compounded feeds for cattle whether pr oduced domestically or 
imported into India.  G/TBT/M/81  
 
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  1.2.13   India – Toys (Quality Control) Order, 2020 (IND/131); Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(IND/143), G/TBT/N/IND/131 , G/TBT/N/IND/143  (IMS ID 63218) 
1.76.   The delegation of the United States  provided the following statement. The United States has 
been raising concerns with India's treatment of imported toys since 2017. With each new 
requirement, India has made it more difficult for exporters to successfully bring legitimate and safe 
toys to m arket. The Quality Control Order for toys was notified on 7 February 2020, with only a 15 -
day comment period. The United States requested an extension of the comment period to 60 to 90 
days, but India rejected that request citing concerns "related to natio nal security, health, safety, 
environment, and deceptive trade practices ". Can India please explain in detail the nature of the 
urgent problems underlying India's assertion that this exception to India's TBT obligations is 
warranted for the proposed Qualit y Control Order? Nonetheless, the United States industry 
submitted comments to G/TBT/N/IND/131  on 2 February 2020 and to G/TBT/N/IND/143  on 23 April 
2020. U S industry has also noted numerous concerns in their comments and letters regarding 
Schedule 2, Scheme 1 of the BIS Compulsory Assessment Regulation of 2018 required by the QCO. 
Most notably, U S industry understands that in order to obtain the licence to apply the Indian 
Standard Mark, manufacturing facilities will be required to undergo audits overseen by BIS. Industry 
further reports that importers will  face multiple fees and registration requirements and be required 
to retain an Indian in -country representative, obtain bank guarantees, and provide an indemnity 
bond. The United States shares U S industry's belief that requiring a facility audit, on -site o r 
otherwise, is unnecessary and inconsistent with international product safety practices. Many 
governments have adopted regulations to ensure that products meet harmonized safety 
requirements by requiring product testing by a laboratory accredited to ISO 1 7025 for the relevant 
tests. Furthermore, international travel restrictions may still be in place in some countries when the 
QCO enters into force in June, making it impossible for exporters to obtain factory audits and 
effectively halting toy imports.  
1.77.   The United States urges India to revise the measure to allow toy importers to rely on Schedule 
2, Scheme 2 of the BIS Compulsory Assessment Regulation, which allows for exporters to use self -
declaration of conformity. In addition to the QCO, importers are su bject to new random import 
sampling requirements under Notification 33. Toys already tested to the Indian standard by 
manufacturers in compliance with the QCO can now be subject to random compliance sampling upon 
importation. Major industry concerns includ e: uncertainty about who pays for the sampling; the 
possibility that goods already deemed in compliance with the Indian standard via the QCO may now 
be denied entry with no recourse for manufacturers; and a delay in goods getting to the point of 
sale. The United States does not understand the need for this additional testing. Many U S companies 
use harmonized international toy safety standards such as ISO 8124, ASTM F963, and/or EN 71, 
and conduct product testing at laboratories accredited by the Internation al Laboratory Accreditation 
Cooperation. The United States urges India to reconsider the full scope of requirements for toys that 
it is now implementing. The combined burdens of the QCO and Notification 33 may discourage many 
companies from exporting toys to India. The difficulty complying with both measures is likely to 
result in an increase in counterfeit and poor -quality toys in the Indian market.  
1.78.   The delegation of the European Union  provided the following statement. The European Union 
is strongly concer ned about India's Toys (Quality Control) Order, 2020 (QCO), and the Amendment 
in Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy). The EU 
outlined its concerns already during bilateral talks with India in the margins of the TBT Committee 
in February 2020 and submitted written comments on 30 March 2020 and 31 March 2020, 
respectively. The EU would be grateful if India could respond directly to the concerns referenced 
below, which are also found in the EU written comment s. 
1.79.   Complex Scheme -I: The new QCO obliges conformity assessment by Indian authorities under 
Scheme -I of Schedule -II of the B IS (Conformity Assessment) Regulations, 2018, which mandates 
compliance of all toy products with Indian Standard (IS) 9873 /IS 15644.  This requirement has been 
applicable to all imported toys since September 2017 through Policy condition No. 2 to Chapter 95 
of ITC(HS), 2017 – Schedule – 1 (Import Policy), notified by India to the TBT Committee through 
Notification no. G/TBT/N/IND/68  on 7 December 2017. Compliance with these standards is tested 
by Indian laboratories accredited by the National Accreditation Boards for Testing and Calibration 
Laboratories (NABL), i.e. laboratories designated for testing such conformity by the Government of 
 
18 For previous statements follow the thread under IMS ID  632 (under dates raised and references) . G/TBT/M/81  
 
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  India. In addition, as of D ecember 2019, according to the Directorate General of Foreign Trade 
(DGFT) Notification 33/2015 -20, customs officials collect samples on a case -by-case basis from each 
consignment of imports of toys and send them to NABL accredited laboratories for testing  the 
conformity with the applicable Indian standards. The EU would like to point out that the proposed 
new measure introduces new burdensome requirements to those already existing as well as a very 
onerous system, which would seem almost impossible to comp ly with as further explained below.  
1.80.   Grant of Licen ces: According to Scheme -I of Schedule  II of BIS (Conformity Assessment) 
Regulations, 2018, manufacturers shall obtain a licence for every factory they own, undergo a factory 
audit by the BIS and provide a list of all machinery, testing equipment and quality control processes 
to the BIS. In this context, the EU would like to point out, that:  
a. The toy industry is mainly comprised of small and medium scale manufacturers. As 
compliance under the proposed QCO ent ails mandatory factory inspections by the Indian 
authorities before a licence is granted, complying with Scheme 1 would require extra time 
and eventually lead to a disruption of the production, with a consequential halt of the 
exports to India;  
b. It seems th at the requirements envisaged under the proposed QCO do not entirely take 
into account the business reality of the toy industry, i.e. the seasonal character of the 
sector, with over half a million different stock -keeping units (SKUs) and multitudes of new 
SKUs being generated every few months. For the time being, the EU points out that it 
remains unclear how licen ces can be obtained, i.e. whether the same licen ce will be per 
item, SKU or category. The EU would therefore like to kindly request the Indian aut horities 
to ensure that the licensing requirements are imposed in a way that a single licence, valid 
also for products newly manufactured during the tenure of the licence, is required per 
factory for all manufactured products (in compliance with IS 9873);  
c. The costs associated with obtaining a licence and, in particular factory audits, will be 
extremely high for smaller manufacturers. In addition, several of them will not be able to 
provide the information required;  
d. In light of the significant number of SKUs  yearly produced by the industry, every six 
months, the BIS will have to audit and review licence applications of thousands of factories, 
both in India and elsewhere. The EU would like to express its concerns to the Indian 
authorities regarding the BIS' re sources needed to ensure a smooth implementation of the 
audits;  
e. The costs associated with licensing could dampen the number of SKUs brought to the 
Indian market, consequently affecting children's access to toys and the growth of the toy 
retail sector;  
f. The requirements set forth in the notified draft are redundant with the international 
standards on safety and quality management systems manufacturers already comply with 
(ex: ISO 9001 for quality management system, ISO 9001 & 14001 for activities required 
for certification).  
1.81.   Taking the above -mentioned considerations into account, the EU would like to kindly request 
India to apply Scheme II of Schedule -II of BIS (Conformity Assessment) Regulations 2018 and 
extend the benefit of self-certification set forth in Scheme II also to toy manufacturers, as it was 
done for the electronic industry under the Electronic and Information Technology Goods 
(Requirement for Compulsory Registration) Order. Should Scheme -I be implemented, manufactu rers 
with an ISO 9001 certification should be exempted from factory audits, allowing them to submit a 
copy of their certification. The EU would also kindly ask the Indian authorities to consider the 
extension of the validity of licence to up to five years as well as remove the requirement for lists of 
machinery and equipment. Moreover, the EU would like to point out that, despite the lack of 
information regarding the Government's timeline to implement the measure, the complexity of the 
Scheme and the number  of licen ces to be granted make it unlikely that the six -months transition 
period indicated will be sufficient. An insufficient transitional period may drain the resources of the 
BIS and lead to significant delays in products to market. To our knowledge, there are also no 
guidelines yet available in respect to e xisting stocks and SKUs already in -market. As a consequence, G/TBT/M/81  
 
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  both an appropriate extension of the transition period and relevant guidelines should be considered 
by the Indian authorities.  
1.82.   Bank Guarantee : According to Article 5.2.5 of the TBT Agreement: "any fees imposed for 
assessing the conformity of products originating in the territories of other Members are equitable in 
relation to any fees chargeable for assessing the conformity of like products of national origin or 
originating in any other country, t aking into account communication, transportation and other costs 
arising from differences between location of facilities of the applicant and the conformity assessment 
body". The EU would like to point out that the fee structure under the proposed QCO does  not comply 
with the above -mentioned provision of the TBT Agreement inasmuch as, while foreign manufacturers 
are required to provide a bank guarantee of USD 10,000, no such requirement is applicable to 
domestic manufacturers. As Scheme -I is factory specifi c and the various components of a product 
are often manufactured in multiple factories, prompt compliance with the requirements will be 
virtually impossible, not only for the industry but also for the BIS. This may also create significant 
cash flow issues for Member companies operating in the toy industry in India. Additionally, according 
to Article 5.1.1 of the TBT Agreement Members shall ensure that "conformity assessment procedures 
are prepared, adopted and applied so as to grant access for suppliers of like products originating in 
the territories of other Members under conditions no less favourable than those accorded to suppliers 
of like products of national origin or originating in any other country, in a comparable situation ". 
However, despite this pr ovision, the new measure introduces a clear discriminatory element as it 
only requires the bank guarantee to foreign manufacturers. Therefore, the EU would like to kindly 
ask the Indian authorities to remove the requirement for a bank guarantee for foreign  
manufacturers.  
1.83.   Fees: Besides a fee for obtaining a licence and bearing the expenses for Indian authorities to 
travel to the manufacturing facilities for inspection, manufacturers are required to pay a "marking 
fee", whose amount has not been determined ye t, based on the products on which the standard 
mark is affixed. In this respect, the EU would like to kindly suggest the Indian authorities to introduce 
an annual marking fee subscription system as an option for the use of the IS standard marks. This 
would  allow for an unlimited usage of the IS standard marks and would reduce the cumbersome 
administrative procedures for companies to verify and keep records of the number of IS standard 
marks used. On a final note, the EU would kindly like to ask India to con firm whether the D GFT 
Notification 33/2015 -20 requirements (notified to the TBT Committee under reference 
G/TBT/N/IND/143)  would be fully replaced with the QCO licensing scheme once implemented.  
1.84.   The delegation of Canada  provided the following statement. Canada wishes to reiterate  the 
importance Canada places on toy regulations that protect the health and safety of children and 
supports WTO Members that put in place measures to achieve this objective. While India did notify, 
on 7 February 2020, its new Toys (Quality Control) Order,  2020, Canada was very disappointed that 
India provided WTO Members with only 15 days, instead of the normal minimum 60 days, to review 
the new measure, consult with relevant stakeholders, and provide comments. It remains unclear to 
Canada what rationale I ndia used to allow only two weeks for Members and stakeholders to review 
the new Order, on the grounds that it was addressing concerns "related to national security, health, 
safety, environment, and deceptive trade practices ". While Canada requested an ext ension of the 
comment period to India,  which was not fulfilled, Canada still provided comments to India on 6  April 
2020, and looks forward to receiving a response from India.  
1.85.   Canada kindly requests that India provide specific examples of the precise (i) le gitimate 
objectives supporting ; and (ii) rationale for the following aspects of the measures: extensive in -
country testing and marking that require separate applications for products in the same family, 
special packaging and/or labelling, and the segregati on of products for the Indian market; and the 
use of technical regulations based on domestic standards, even though India's domestic standards 
are aligned with international toy safety standards. Can India please specify how consistency with 
non-discrimina tory treatment for imported toys relative to domestically produced toys is maintained 
under the new requirements, according to which foreign manufacturers must: nominate and retain 
an in -country Indian representative; obtain a performance bank guarantee; a nd provide an 
indemnity bond? Canada looks forward to further engagement from India on this important issue.  
1.86.   In response, the delegation of India provided the following statement. India would like to 
thank the United States, the European Union and Australi a for their continued interest in the matter. 
On various issues raised by the Members in their written submissions, India would like to state that 
Toys (Quality Control) Order, 2020 has been issued under the provisions of BIS Act, 2016 and Rules G/TBT/M/81  
 
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  and Regula tions framed thereunder, which envisages conformity assessment Scheme -I of BIS 
(Conformity Assessment) Regulations , 2018. Scheme -I has been chosen for the purpose of ensuring 
stricter monitoring of quality of goods as the objective of the conformity asses sment measure 
(licensing) is to primarily ensure safety of toys for use of children and BIS keeps the same under 
focus with minimum possible costs involved. The Quality Control Order is equally applicable to 
foreign manufacturers exporting toys to India as  well as the domestic manufacturers. As per the 
Toys (Quality Control) Order, 2020, every toy shall conform to corresponding Indian Standards 
specified therein and shall bear the standard mark under the licence from BIS as per Scheme -I of 
BIS (Conformity A ssessment) Regulations, 2018. In this context, it is worth mentioning here that 
the Indian standard IS 9873 is a revision of standard ISO 8124.  
1.87.   On the query related to application of international standard, India would like to state that 
ISO 9001 stipulat es only the requirements for Quality Management Systems (QMS). The conformity 
assessment scheme (Scheme -I) of BIS specified in the QCO is focused at product conformity to the 
relevant standard (in accordance with type 4 certification scheme of ISO/IEC 1706 7) through third -
party lab testing and verifying requisite quality assurance measures put in place by the manufacturer 
for regular production to ensure continual conformity of the product through factory inspection. The 
requirement of list of machinery and  test equipment is a part of the evaluation system as per 
Scheme -I of BIS (Conformity Assessment) Regulations, 2018. Similarly, the packaging requirements 
are mentioned in the standard itself.  
1.88.   The date of implementation of the Toys (Quality Control) Order , 2020 is 1 September 2020, 
as per DPIIT's notification dated 25 February 2020. BIS is working to ensure the implementation of 
the order. Having said so, based on the facts and data, industry, if required, can always make a 
request to the Government of Ind ia, taking into account the progress made and assessment of need 
for extension. Under this scheme, BIS licence will be granted to a manufacturer of toys as per the 
Indian Standard and all varieties (items/models/SKU , etc.) of toys covered in the standard w ill get 
covered under the same licence. To cover all the varieties in a standard under the licence, BIS will 
be issuing grouping guidelines shortly with an aim to specify a minimum number of varieties of toys 
to be tested, to consider covering a larger num ber of varieties in the scope of the licence. This will 
be with an aim of optimum testing to achieve the objective of ensuring safety of all toys for children. 
BIS has already shared the draft grouping guidelines with stakeholders and sought their inputs 
before finalizing such requirements.  
1.89.   As per Scheme -I of BIS (Conformity Assessment) Regulations, 2018, the manufacturers of 
Toys shall be required to take BIS licence for each factory (manufacturing premises). However, the 
scheme does not specify any provi sions which are likely to have the compliance and cash flow issues 
expressed by these Members. So far as the validity of such licences under the provisions of Scheme -
I of BIS (Conformity Assessment) Regulations, 2018 is concerned, the licence can be grante d for a 
period of minimum one but up to two years and subsequently can be renewed for a period of 
minimum one but up to five years. BIS is already operating product certification scheme as per 
Scheme -I for more than 970 products as per BIS (Conformity Asse ssment) Regulations. It may be 
mentioned that out of more than 36,000 licences granted by BIS, more than 80% of manufacturers 
who have taken BIS certification licence, are from the Indian MSME sector. This includes about 60% 
of licences on voluntary basis.  Further, the BIS, on a continual basis, analyses the resources required 
from time to time and ensures appropriate measures.  
1.90.   Members have also sought to know the reason for the need of Performance Bank Guarantee 
(PBG) from foreign manufacturers. In this r egard, India would like to inform the Members that PBG 
is required after Grant of BIS licence through signing of an agreement between BIS and the Foreign 
manufacturer. The need for PBG from a foreign manufacturer is to ensure that in case of any violation 
of the BIS Act, Rules and Regulations including non -payment of marking fee dues and breach of 
terms and conditions of the licence, BIS would be able to enforce the PBG. On the other hand, in 
case of domestic manufacturers, BIS can approach and seek compens ation through domestic courts. 
PBG will be invoked only when there is any breach and covers civil liability and loss of revenue, if 
any, that may arise during the tenure of the licence or thereafter. The amount shown against bank 
guarantee  remains with the  concerned bank in the form of refundable security and it should not be 
construed as expenditure. Hence submission and maintenance of PBG by foreign manufacturers 
should not be construed as discrimination between domestic and foreign companies. Moreover, bank 
guarantees  are also common in international trade with regard to performance of contracts.  G/TBT/M/81  
 
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  1.91.   On DGFT Notification No. 33/2015 -20 (notified to the TBT Committee under reference 
G/TBT/N/IND/143)  referred by Members in their written comments, India would like to mention that 
the Guidelines on sampling requirements are as per the instructions issued by the competent 
authority, in particular, the Customs  authority, under Customs Act, 1962 and Regulations fram ed 
thereunder. Any denial of entry of goods including toys in India is governed by such provisions with 
appropriate appeal provisions. It is also informed that the requirements under this DGFT notification 
would be fully replaced with the QCO licensing sch eme, once implemented.  
1.2.14   India – FSSAI's Food Safety and Standards (Food Products Standards and Food 
Additives) Regulations, 2011 and the new implementing veterinary certificate for dairy 
products (IMS ID 63319) 
1.92.   The delegation of the European Union  provided t he following statement. India has in 
December 2019 adopted a new veterinary import certificate for milk and milk products based on 
Food Safety and Standards Regulation 2011, that is of great concern to the EU. The provisions of 
FSSAI's Regulation defines c heese as a "product produced from non -animal rennet or another 
suitable coagulating agent, which applies equally to both domestic and imported foods " (as reflected 
in the notification G/SPS/N/IND/236) . It was , however , still possible for cheese -containing animal 
rennet to access the Indian market provided that it was correctly labelled. The new veterinary 
certificate requires that milk products have not been manufactured using animal rennet. As most 
European cheese is traditionally made with animal rennet, this means that there is  a de facto  ban 
for European cheese entering the Indian market. While the EU fully supports the importance of 
labelling the presence of animal rennet, the EU considers that this new certificate is not proportionate 
and not in line with the TBT Agreement. V eterinary certificates are to address sanitary (human or 
animal) health issues. There is no scientific evidence that cheese produced with animal rennet is 
harmful to health, or more harmful than cheese produced with artificial/vegetal rennet. We therefore 
would ask India to change the provisions of that veterinary certificate and allow for a label clearly 
indicating the presence of animal rennet in the cheese, as it was previously the case. This label 
would allow consumers to make an informed choice.  
1.93.   In res ponse, the delegation of India provided the following statement. India would like to 
thank the European Union for their continued interest in the matter. India would like to state that 
the provision of use of non -animal rennet in the manufacture of cheese has been there in India's 
Food Safety and Standards Regulations (FSSR) notified in 2011 and the erstwhile Prevention of Food 
Adulteration Rules as well. Hence this provision is not a new provision. During a recent revision of 
the milk and milk product stan dards in FSSR, these provisions were retained as such and continue 
to be a specified requirement regulation therein. The Department of Animal Husbandry and Dairying 
had already mandated the need for veterinary certificate for importers of milk and milk pro ducts in 
India. Hence , FSSAI seeking a copy of the veterinary certificate should not be construed as a new 
requirement introduced by FSSAI. Moreover, the Department of Animal Husbandry and Dairying in 
the Government of India has recently aligned the Veteri nary certificate with India's FSSR in respect 
of the prohibition on the use of animal rennet.  
1.2.15   European Union – EU Commission Regulation (EU) 2019/2013 for Energy Labelling 
of Electronic Displays, G/TBT/N/EU/610  (IMS ID 63420) 
1.94.   The delegation of China  provided the following statement. C hina appreciates that the EU has 
notified the regulation and supports the EU's efforts to provide customers with transparent and 
objective information on the energy efficiency of electronic displays. However, China notes that the 
implementation time of the  regulation has brought unnecessary trade barriers to manufacturers. 
According to the Regulation (EU) 2019/2013, it shall be implemented from 1 March 2021. However, 
point 1(a) of Article 3 shall be implemented from 1 November 2020. Since the new label regu lation 
EU 2019/2013 has not been comprehensively implemented, detailed test methods and cases have 
not been given . In the time period between 1 November 2020 and 1 March 2021, manufacturers 
can only use the test standards and methods specified in the forme r labelling regulation EU 
1062/2010 for testing, while determin ing the new energy efficiency level according to the calculation 
formula specified in EU 2019/2013. The switching time for the old and new regulations is not 
reasonable, which will result in si gnificant discrepancies between the energy efficiency level on the 
energy efficiency label attached by the manufacturer and the actual energy efficiency level of the 
 
19 For previous statements follow the thread under IMS ID  633 (under dates raised and reference s). 
20 For previous statements follow the thread under IMS ID  634 (under dates raised and references) . G/TBT/M/81  
 
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  product. It will mislead consumers. Therefore, China suggests the implementation time of p oint 1(a) 
of Article 3 be consistent with the implementation time of the EU 2019/2013 regulation, the relevant 
test guidelines should be issued as soon as possible , and the test standards as well as test cases 
should be given in due course.  
1.95.   In response, th e delegation of the European Union  provided the following statement. Both 
Regulations on electronic displays, Ecodesign Regulation (EU) 2019/2021 and Labelling Regulation 
(EU) 2019/2013, already entered into force. They generally start applying from the sa me date, i.e. 
1 March 2021. However, in accordance with Article 11 of Regulation (EU) 2019/2013, Point 1(a) of 
Article 3 already applies as from 1 November 2020. This provision refers to the obligation of suppliers 
to provide the new label for a period of four months in advance of the start of application of the 
regulation. This is to allow retailers to already display the new label in shops as from 1 March 2021. 
This indeed means that all test results in principle need to be available about four months in advance 
of the start of application date, i.e. 1 March 2021. As the new label may only be displayed from 
1 March, we do not believe that it will mislead consumers. To this end, an information campaign is 
also foreseen to explain to consumers the transition  to the new labels (a new label will be used for 
five additional products, from that same date) around the time they are set to appear in shops and 
in advertisements.  
1.96.   Notwithstanding the above, we recogni ze that the deadline of 1 November may turn out to 
be difficult to meet for some suppliers in a situation where widespread lockdowns due to the 
COVID -19 emergency has significantly affected production chains and testing activities in many 
countries. Whereas the EU's regulatory process would not allow change s in the legal timeframe to 
be formally adopted, as proposed by China, we agree that there may be a need for additional 
flexibility in light of the current exceptional circumstances. We are therefore currently seeking 
political approval to issue a formal C ommission Notice inviting national market surveillance 
authorities in EU member States to duly consider the principle of proportionality and the exceptional 
circumstances when they exercise their discretion on how to enforce the obligations related to the 
supply of a rescaled label applicable as of 1 November 2020. In practice, such an approach might 
provide manufacturers with up to four additional months to comply with their obligations, as long as 
they still comply with the requirement in point 1(a) menti oned above no later than by 1 March 2021. 
Any such Notice would be published in the Official Journal of the EU.  
1.2.16   Kingdom of Saudi Arabia – SASO 2663 Air Conditioner Minimum Energy 
Performance, labelling and testing requirements for low capacity window type and single -
slit, and related certifications, G/TBT/N/SAU/526  (IMS ID 63521) 
1.97.   The delegation of China  provided the following statement. The discrepancy in the results of 
conformity a ssessment : The room air conditioners (hereinafter referred to as air conditioners) 
exported to Saudi Arabia from China have all passed the tests of the relevant Saudi Arabia and 
international standards, i.e., SASO IEC 60335 -2-40 and SASO 2663, and obtained  the S tandards, 
Quality, and Metrology Organization (SASO)  certification of SGS/TUV/BV. However, the results of 
sampling tests on the refrigerating capacity and energy efficiency ratio of the air conditioners 
conducted by Saudi Arabian Customs were quite d ifferent from testing results of institutions 
authorized by SASO in China, generally 3  to 5% lower. Several brands of major air  conditioner 
manufacturers in China encountered similar problems. As Saudi Arabia side failed to provide further 
information as t esting reports or data other than a simple non -conformity result, the export 
enterprises could not find out the reasons of non -conformity. The testing reports and sufficient data 
are needed for finding out the reason causing the discrepancy, and hereby cor recting the non -
conformity. China suggests that Saudi Customs carry out the test comparison with China Customs 
Air Conditioner Laboratory to study the deviation of test data.  
1.98.   Insufficient sampling in random checks : Saudi Arabia Customs only selected one sa mple for 
random checks to determine whether the whole batch of products are qualified or not. In accordance 
with international practice, when the first test fails, two  to three more samples shall be taken to 
make a reliable judgment. The Saudi Arabian appr oach seems to be inconsistent with these 
international practices. According to Article 2.4 of the TBT Agreement, China suggests that the Saudi 
Arabian side adopts the internationally accepted rules for the random checks.  
 
21 For previous statements follow the thread under IMS ID  635 (under dates raised and references) . G/TBT/M/81  
 
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  1.99.   Lack of a complaint review procedur e: Saudi Arabian Customs did not accept re -testing 
applications, the enterprises found it very difficult to identify the problems. Article 5.2.8 of the TBT 
Agreement provides that "... Members shall ensure a procedure exists to review complaints 
concerning  the operation of a conformity assessment procedure and to take corrective action when 
a complaint is justified. " Therefore, China strongly recommends the Saudi Arabian side establishes 
a complaint review procedure for re -testing the unqualified products.  
1.100.   Time limit for the renewal of Energy Efficiency Certification : The Saudi official registration 
system provides SASO 2663 energy efficiency certificates one -year validity and the renewal 
application can only be submitted no more than one month prior to the expiry of these certificates. 
The short validity of certification and the short period of time allowed for renewal processing greatly 
hinder the manufacturers from continuous supply, resulting in unpredictability of trade. According 
to Article 5.1.2 of the TBT Agreement, China suggests that Saudi Arabia extends the validity period 
for the relevant certificates and revise application period for renewal of the certificates, so that the 
air conditioner suppliers could meet the requirements of Saudi Arabia and avoid the negative effect 
on bilateral trade. China thanks once again the attention from the Saudi Arabian delegation and 
looks forward to an opportunity to work this out in the very near future.  
1.101.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement. 
Saudi Arabia thanks China for raising these concerns regarding SASO 2663/2018 "Air conditioner 
Minimum Energy Performance – labelling and testing requirements" by mentioning the differences 
between the testing results issue d by the certification body (accepted by SASO) in China and the 
testing conducted by the accredited labs in Saudi Arabia, among other issues. The Saudi standard 
for air conditioners allows 5% tolerance based on the values declared by manufacturer which com ply 
with international practices, taking into consideration, the variation in test results between 
laboratories as well as the production process. It is worth mentioning that all products that are 
granted a certification from Saber platform can access the Saudi market easily without any obstacles. 
However, the custom agency entitled to conduct a random check at ports for certain shipments, 
which aligned with international practices. The supplier or the agent of the manufacturer in Saudi 
Arabia has the right  to obtain detailed data related to the testing report which included the reasons 
for non -conformity. In case there is any complaint regarding these reports, the competent 
authorities in Saudi Arabia have a process to tackle the complaint in a bias -free ma nner. In terms 
of the time limit for the renewal of Energy Efficiency Certification, SASO allowed the renewal process 
of the certificate three months prior to the expiry date which gives the importer sufficient time to 
conduct these processes. SASO welcome s the suggestion of inter -comparisons of test results 
between the factories and international laboratories located in China with the SASO's laboratories 
and other accredited labs in Saudi Arabia.  
1.2.17   Australia – Maturation requirements for imported alcohol (IM S ID 63622) 
1.102.   The delegation of Brazil  provided the following statement. Brazil fully supports Australia's 
legitimate objective to pursue high quality standards for the commercialization of alcoholic 
beverages in its domestic market. However, we would like to  raise concerns about technical 
requirements for imported alcohol that are more trade -restrictive than necessary to achieve any 
legitimate objective under the framework of the TBT Agreement. Currently, the Australian Customs 
Notice Nº 2007/19, following up  on Section 105A of the Customs Act 1901, requires that some 
alcoholic beverages must be matured in wood for a minimum of two years before delivery from 
Customs control. This covers all beverages under tariff classifications 2208.20.10, 2208.30.00 and 
2208.40.00. Even though said Notice only refers directly to brandy, rum and whisky, it encompasses 
tariff line 2208.40.00 (rum and other spirits obtained by distilling fermented sugar -cane products), 
under which cachaça is classified in Australia. By granting the same treatment to cachaça and rum, 
the Australian Government does not allow imports of cachaça that are not matured for at least two 
years in wood. Such a requirement does not relate to any quality standard or sanitary requirement 
applicable to cachaça . 
1.103.   In late 2019, Australian Border Force (ABF) opened a public consultation process to review 
some provisions related to Customs Act 1901. According to the webpage for the public consultation, 
it is also our understanding that the final regulation that will  follow the public consultation is likely 
to have implications in terms of labelling requirements. Brazil welcomes Australia's willingness to 
update its requirements and thanks the opportunity that was granted for our private sector to 
 
22 For previous statements follow the thread under IMS ID  636 (under dates raised and references) . G/TBT/M/81  
 
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  provide comments. We  also thank Australia for the clarifications provided during the last couple of 
meetings we had on this matter. We encourage Australia to consider properly notifying this public 
consultation and the next steps of the regulatory process. In light of this co ncern, could Australia 
please explain the rationale for the establishment of such maturation requirements applicable to 
cachaça? In terms of labelling requirements for products other than rum, brandy and whisky, what 
will the implications of the new regula tion be? Could Australia provide timeframes for the publication 
of the final text? Will Brazilian comments be taken into account? We look forward to continuing our 
bilateral engagements with Australia on this matter.  
1.104.   In response, the delegation of Australi a provided the following statement. Australia is 
reviewing its legislative and tariff classification framework for the import of unmatured alcohol 
products. Australia currently applies equivalent requirements on domestic manufactured products 
and imported products that are classified as whisky, brandy or rum to be matured in wood for a 
period of at least two years. Australia's review process is considering an appropriate pathway to 
enable imports of unmatured spirits such as cachaça without breaching this m aturation requirement. 
Australia acknowledges Brazil's bilateral engagement on the review of Australia's maturation 
requirements for alcohol. Representatives from the Brazilian Embassy participated in consultation 
sessions on the review process led by the ABF. The issues raised in those sessions, as well as written 
submissions, will inform the proposed legislative amendments. The timeframe for the proposed 
legislative amendments has been impacted by changes to Australia's Parliamentary sitting calendar 
due to COVID -19. Australia is committed to progressing these amendments as quickly as possible. 
The ABF will release an exposure draft of proposed amendments for public comment when available.  
1.2.18   Russian Federation – Regulation on safety of alcoholic beverages, Technical 
Regulation TR EAEU 047/2018 (IMS ID 63723) 
1.105.   The delegation of Mexico  provided the following statement. Eurasian Economic Community  
Technical Regulation EAEU  047/2018 on safety of alcoholic beverages.  The delegation of Mexico 
refers to Eurasian Economic Community Technical Regulation EAEU  047/2018 on safety of alcoholic 
beverages, adopted on 20  November  2018, and which will enter into force in 2021.  During the 
February  2020 meeting of the TBT  Committee, Mexico held a bilateral meeting with the delegation 
of the Russian Federation in order to share concerns about this technical regulation, specifically 
about its scope of application with respect to beverages such as tequila. There has also been  an 
exchange of information with the Eurasian Economic Commission. However, it has not been possible 
to confirm whether it applies to tequila.  Should the technical regulation apply to tequila, Mexico 
would be interested in beginning a bilateral dialogue wi th the relevant authorities in the Russian 
Federation in order to allow it to consider the analysis of the Mexican technical regulation applicable 
to that product, Mexican Official Standard NOM -006-SCFI-2012: Alcoholic 
Beverages  - Tequila  - Specifications,  on the following topics . Definition of tequila : The Eurasian 
Economic Community's technical regulation only considers two categories of products and in neither 
of those categories could tequila be included because of its physico -chemical characteristics . 
Consideration of physico -chemical characteristics : Should the technical regulation apply to tequila, 
and given that the Russian Federation has recognized tequila as a Designation of Origin since 2012, 
it would be important to consider the physico -chemical characteristics of tequila set out in 
NOM-006-SCFI-2012, especially regarding methanol levels. The levels of methanol proposed in the 
Eurasian Economic Community's technical regulation are below the levels established for tequila in 
the applicable Mexican regulations.  
1.106.   During the February  2020 meeting of the TBT Committee, the delegation of the Russian 
Federation stated that the technical regulation was currently planned to enter into force in 2021, but 
this could change and be subject to comments and adjust ments. In light of the above, the delegation 
of Mexico respectfully requests the delegation of the Russian Federation to provide the following . 
Official confirmation of the scope of the measure . We request that it be formally confirmed whether 
Technical Re gulation EAEU  047/2018 applies to tequila. Should it not be possible for you to respond, 
we request to be advised of a person with whom we can communicate within your relevant authority 
to obtain a response to this request . Follow -up information . The deleg ation of Mexico would 
appreciate receiving updated information on the date of entry into force of Technical Regulation 
EAEU  047/2018, as well as on the next steps to be taken and the process of implementation.  The 
 
23 For previous statements follow the thread under IMS ID  637 (under dates raised and references) . G/TBT/M/81  
 
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  delegation of Mexico thanks the delegation  of the Russian Federation for considering this statement 
and the requests made therein.  
1.107.   In response, the delegation of the Russian Federation  provided the following statement. The 
Russian Federation would like to thank Mexico for its interest in the Techn ical Regulation on safety 
of alcoholic beverages. We can confirm that the Technical Regulation covers all alcohol products 
including Tequila. It enters into force on the 9 January 2021 with the transition period till 2024. 
During the transition period cert ificates of conformity issued before entry into force will be valid until 
2024. All comments made by Mexico regarding technical characteristics of Tequila as well as request 
for bilateral meeting will be to the responsible authorities for consideration. We  remain open for 
discussions in any format on this issue.  
1.2.19   Colombia – SIC External Circular 002 on Notices for Mobile Device Packaging (IMS 
ID 63824) 
1.108.   The delegation of the United States  provided the following statement. We learned from U S 
industry that Colom bia's Superintendency of Industry and Commerce (SIC) recently adopted 
External Circular 002 on Notices for Mobile Device Packaging, which requires producers, suppliers, 
or retailers of mobile devices to affix mandatory notices to mobile device packaging. T hese notices 
must indicate the cellular network supported by the mobile device (2G, 3G, 4G, or 5G), and must 
be no smaller than 7  cm wide by 3  cm tall. This label size is unique to the Colombian market, and 
US industry has raised concerns that such labels are unnecessarily large. We ask though the U S 
Enquiry Point on 27 February, 12 March, and 17 April 2020 that Colombia notify External Circular 
002 to the WTO as soon as possible, provide for a reasonable perio d for comments, and consider 
any comments received for potential amendment of the measure before implementation. To date, 
we have only received automated responses that the requests have been received and the request 
has been received and sent to the regul atory authority. We understand that during the brief public 
consultation on this measure, both U S and Colombian industry expressed that the labelling 
requirement is overly burdensome, is not directed to any perceived market failure, and would not 
provide a  clear benefit to consumers. Can Colombia please explain its objective in issuing mobile 
device labelling requirements that include information on the cellular networks supported by each 
device? Did SIC conduct any studies or impact assessments prior to is suing the measure? Can 
Colombia please explain the basis for the unusually large size requirements of the notification label? 
US industry has also expressed concerns regarding the lack of an adequate transition period for 
compliance. We understand that the se requirements will enter into force on 20 May 2020. We 
request that Colombia delay implementation by at least six additional months from the date of the 
finalization of the measure after a public comment period and consideration of those comments to 
allow time for producers, suppliers, and retailers of mobile devices to adapt their products or 
methods of production to these new requirements.  
1.109.   In response, the delegation of Colombia  provided the following statement. We thank the  
United States for the inform ation submitted relating to Circular 002 of 7  November  2019, which 
incorporates Point 2.19 into Title II, Chapter 2, of the Single Circular of the Colombian Supervisory 
Authority for Trade and Industry in order to establish labelling requirements for mobil e devices.  In 
this connection, we advise that the Supervisory Authority for Trade and Industry is still reviewing 
and analysing the comments submitted by the United States.  Once we have any developments or 
information in this regard, we will be able to pas s these on. As some decisions of our government 
authorities have been delayed because of the COVID -19 health emergency, with attention currently 
focused on this situation, your understanding on this matter would be appreciated.  
1.2.20   India – Expansion of BIS Cer tification to plugs, socket outlets and power cords 
(IMS ID 63925) 
1.110.   The delegation of China  provided the following statement. The Ministry of Commerce and 
Industry of India specified that the plugs and socket  outlets and related products, shall bear the 
standard mark under a licence from the B IS. The new order shall come into effect from 1 June 2020. 
China finds that the expansion of BIS is not consistent with the WTO rules and negatively impacts 
Chinese exporters. China thanks India for providing an adaptati on period. However, due to the 
COVID -19, manufacturers need a longer period of time to comply with the new requirements. As 
 
24 For previous statements follow the thread under IMS ID  638 (under dates raised and references) . 
25 For previous statements follow the thread under IMS ID  639 (under dates raised and references) . G/TBT/M/81  
 
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  compliance with this order involves lots of efforts, such as to go through certifications, refit their 
facilities and equipment in a dvance, Chinese enterprises are unable to organize production, deliver 
goods before the scheduled effective date of this June, which will result in substantial negative 
impacts on the enterprises and the relevant international trade. In light of the above -mentioned 
situation, we suggest India postpone the implementation for one year so that the importers and 
exporters are able to cooperate to comply with the new requirements. According to Articles 5.2 and 
5.6 of the TBT Agreement, we suggest India to notify  the new requirements of BIS certification to 
WTO/TBT Committee, and clarify the assessment procedures, relevant costs and relevant policies.  
1.111.   In response, the delegation of India provided the following statement. India would like to 
thank China for their c omments on this issue. In this regard, India would like to mention that the 
QCO on Plugs and Socket  Outlets and Alternating Current Direct Connected Static Prepayment 
Meters for Active Energy (Quality Control) Order, 2019 was prepared by  the Department for  
Promotion of Industry and Internal Trade (DPIIT)  in the Government of India after consultations 
with several stakeholders including the BIS. Thereafter the draft QCO was notified to WTO 
(G/TBT/N/IND/86  dated 18 December 2018) and was available to Members for six months, for their 
comments. DPIIT got no adverse comments from WTO Members. Pursuant to this, it was gazette 
notified vi a S.O. 4353(E) dated 4 December 2019 with implementation date with effect from 1 June 
2020. The purpose of this QCO is safety of public, environment protect ion and to stop deceptive 
trade practices as well as sub -standard products. On account of the difficulties in implementation 
due to COVID -19 pandemic, DPIIT has extended the implementation date of said QCO for a period 
of six months, beyond 1 June 2020, af ter consultation with the stakeholders including the industry, 
the Consumer Electronics and Appliances Manufacturers Association (CEAMA), Confederation of 
Indian Industry (CII)  and BIS. Now the implementation date will be 1  December  2020. This has been 
notified in official gazette dated 18 May 2020 and is available on the website of DPIIT.  
1.2.21   Myanmar – Regulation on importation of alcoholic beverages (IMS ID 64026) 
1.112.   The delegation of Mexico  provided the following statement. The delegation of Mexico refers  
to the draft procedures on the importation of spirits conveyed by the Government of Myanmar to 
the Asia Pacific International Wines and Spirits Alliance on 20 June 2019.  The Government of Mexico 
sent official communication 523/01/058/20.IX.2019 on 20  September  2019 to the National 
Standards and Quality Department of Myanmar and held a bilateral meeting during the November 
2019 TBT meeting. The Government of Mexico's main concern relates to the 12 -year ageing 
requirement contained in the draft procedures. T his requirement implies that the importation into 
Myanmar of alcoholic beverages aged less than 12 years will not be permitted. This requirement 
would represent a barrier to imports of tequila, as none of the types of tequila  that are produced 
under the co rresponding technical regulation (Mexican Official Standard NOM -006-SCFI-2012: 
Alcoholic Beverages -Tequila -Specifications) would be able to meet such a requirement. It is also 
important to mention that, should this requirement be linked in some way to the quality of the 
beverages subject to the measure, in the case of tequila, quality is not strictly related to years of 
ageing.  The official communication sent by the Government of Mexico in September 2019 contains 
further details on this matter.  
1.113.   The delegati on of Mexico would also like to reiterate its concern over Myanmar's failure to 
comply with the transparency commitments contained in Article 2.9 of the WTO Agreement on 
Technical Barriers to Trade (TBT Agreement).  The draft procedures on the importation o f spirits 
establishes mandatory specifications that must be met for products to be imported into that country, 
which is why it constitutes a "technical regulation" under the terms of the TBT Agreement and must 
be notified to the Members of the TBT Committe e under the provisions of Article 2.9 of the TBT 
Agreement. In light of the above, the delegation of Mexico kindly reiterates the following requests 
to the delegation of Myanmar: (i) it requests a response to official communication 
523/01/058/20.IX.2019 or , failing that, follow -up information on the consideration being given to 
that communication; (ii) it requests clarification on the scope of application of the measure, 
specifically if it applies to imports of tequila or if it is limited to some categories  of alcoholic beverages 
or spirits; and (iii) it requests that the Members of the WTO's TBT Committee be notified of the draft 
procedures, and that information be provided on their entry into force, the next steps to be taken 
and the process for their impl ementation. The delegation of Mexico thanks the delegation of 
Myanmar for considering this statement and the requests made therein.  
 
26 For previous statements follow the thread under IMS ID  640 (under dates raised and references) . G/TBT/M/81  
 
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  1.114.   The delegation of Myanmar  did not provide a response to the concerns raised. These 
concerns were subsequently transmitted to  the relevant authorities.  
1.3  Previously raised concerns  
1.3.1   China – Requirements for information security products, including, inter alia , the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and it s on-going revision and the Multi -Level Protection 
Scheme (MLPS) ( IMS ID 29427) 
1.115.   The delegation of the European Union  provided the following statement. Regarding the M LPS, 
the EU would like to refer to its previous comments regarding the draft "Guidelines fo r grading of 
classified cybersecurity protection". Together with the wide scope of application of protection Level 
3 and above, under the established MLPS, this has led to unwarranted and significant market entry 
restrictions. The EU's main concerns with r egard to the Guidelines are (i) the further extension in 
scope of protection level three and above; (ii) the nature of the expert review that the Guidelines 
prescribe; and (iii) a lack of clarity in certain definitions. The EU calls for enhanced proportion ality 
and transparency in the implementation of the Cyber -MLPS, instead of introducing burdensome 
requirements and broadening the scope of Level 3 networks. The lack of access to relevant Chinese 
standards developing organizations  becomes particularly pres sing with regard to the Cyber -MLPS, 
which will draw heavily on a number of mandatory and recommended standards developed by these 
standardi zation bodies. The EU notes the recent positive developments in accessing Working Group 
3 on encryption of the TC260 standards development organi zation. However, no semiconductor 
companies have yet been admitted. We continue to monitor the developments closely. The related 
industry -level standardi zation body, the Cryptography Standardisation Technical Committee (CSTC), 
has only one single foreign industry participant. The EU therefore calls once again for the State 
Cryptography Administration to make information accessible to all industry stakeholders, including 
EU-invested enterprises registered in China, which should al so be able to participate in the 
formulation of said standards and specifications on an equal basis. We would also like to request 
that stakeholders be informed in advance about the entering into force of these measures.  
1.116.   Moreover, the EU also notes that, l ast May, the State Administration for Market Regulation 
released core MLPS 2.0 series of national standards, which took effective last December. To comply 
with the Cyber -MLPS regulation, these MLPS 2.0 series of standards broadly extend their scope from 
traditional information systems to network infrastructure, critical information systems, websites, big 
data centres, cloud computing platforms, mobile internet and other areas. We therefore call on 
relevant Chinese authorities, including SAMR and relevant st andardi zation bodies, to officially specify 
the scope of those standards and avoid further unnecessary burdens on foreign industry. We 
understand that the draft Cyber -MLPS is expected to replace/upgrade the administrative regulations. 
We hope that our comm ents will be useful in further developing the draft. In particular, we would 
like to see the key concepts clarified, relevant standards specified and responsible authorities defined 
so that complexity, costs and compliance risks can be mitigated. The EU en courages cross -ministerial 
coordination on cybersecurity legislation and standardi zation. Finally, we ask that China confirms 
whether the revised draft will be notified to the WTO for comments to allow for adequate participation 
of interested parties.  
1.117.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding the China's "Regulation on the Administration of Commercial Cipher Codes " and "Cyber 
Security Multi -Level Protection Scheme. " Japan would like to refer to the previous statement we 
made at the last TBT Committee in February 2020. Japan would like to request that China provide 
relevant information regarding the current revision process and that the regulations would be 
implemente d transparently.  
1.118.   In response, the delegation of China  provided the following statement. In order to implement 
the requirements of promoting administration in accordance with the law, and to deepen the reform 
of "streamline administration and delegate power s" in the field of commercial cryptography, China 
is revising the Regulations on the Administration of Commercial Cryptography in accordance with 
the legislative spirit of the Law on Cryptography. The revision of the Regulations follows the 
principles of l aw-based, open, transparent and on a scientific basis, besides, China will solicit 
opinions widely and ensure the stakeholders' participation in legislative activities through legal 
 
27 For previous statements follow the thread under IMS ID  294 (under dates raised and references) . G/TBT/M/81  
 
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  means. Now, the revision of the Regulation is still under study, it will b e open for public comments 
in due course. Regarding the MLPS, with technological developments, in response to more 
complicated cybersecurity issues, information security multi -level protection scheme needs to be 
improved. Based on experiences in past years  and responding to new development, cybersecurity 
law requires China to carry out the cybersecurity MLPS, which is completing and improving on 
information security MLPS. Now, cybersecurity MLPS regulation is under drafting, which will replace 
the former ad ministrative measures on information security MLPS. This MLPS regulation was open 
for comments in June 2018.  
1.3.2   European Union – Draft Implementing Regulations amending Regulation (EC) No. 
607/2009 laying down detailed rules for the application of Council Reg ulation (EC) No 
479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/44 , G/TBT/N/EEC/264 , G/TBT/N/EEC/264/Add.1 , G/TBT/N/EU/570 , 
G/TBT/N/EU/571  (IMS ID 34528) 
1.119.   The delegation of the United States  provided the following statement. It is very disappointing 
that the United States must again raise its concerns with the EU's revisions to its draft regulation on 
geographical indications and traditional terms for wine; and specifically, our industry's pending 
applications for traditional terms. The EU's persistent failure  to provide any information leaves us no 
choice. Since the June 2018 TBT Committee meeting, the EU has been saying that the pending 
applications for traditional terms were still under consideration, but that it could not provide a precise 
timeline for appr oval. Why is the EU still unable to provide any estimate or tell us where in the 
process these applications are after nearly two years? As we indicated at the November 2019 and 
February 2020 TBT Committee meetings, it would be helpful if the EU could provi de some 
transparency about the status of other applications so that we can see how our applications compare. 
As requested during the February 2020 TBT Committee meeting, please tell us the following: how 
many applications for traditional terms have been lo dged over the last 10 years; how many of those 
applications have been approved, rejected, or remain pending; what is the average time between 
application and a final decision; for pending applications, how long have they been waiting; and how 
many of the a pplications have come from member States. We also remain concerned about the EU's 
efforts to restrict the ability of our producers to use common descriptive tools for labelling and 
marketing their products, such as restricting the use of the term "barrel a ged" and certain bottle 
shapes, to wines with geographical indications. Now that the EU has notified the revised draft 
regulation, the United States once again requests the EU to move expeditiously to approve our 
industry's applications so that we can remo ve this long -standing  item from this Committee's agenda, 
as well as the agenda of the WTO Council on Trade in Goods. Lastly, can the EU confirm how the 
processing of these applications has changed, if at all, over the last year following the most recent 
Parliamentary elections? The United States asked for clarification on this point during the November 
2019 and February 2020 TBT Committee meetings but did not receive clarification from the EU.  
1.120.   The delegation of Argentina  provided the following statement. We wish to thank the United 
States  for including this specific trade concern on the Committee's agenda. It is one that we share.  
Argentina reiterates the concerns expressed at previous meetings of this Committee regarding the 
discrimination suffered by national wines, which are prevented from using the traditional terms 
"Reserva" and "Gran Reserva" on their labels. It should be recalled that Argentina duly complied 
with the substantive procedure provided for in EU regulations for the registration of thes e traditional 
terms between 2009 and 2012. However, the EU never sought formal approval, nor did it provide a 
legal basis for this deliberate omission.  In line with previous statements given by our country in the 
TBT Committee, we once again urge the EU to  activate all applications for the registration of 
traditional terms filed by third countries such as Argentina, which have come to a standstill without 
any legal justification, thereby constituting a technical barrier to trade.  
1.121.   The delegation of Brazil  provided the following statement. Brazil would like to once again 
second the concerns raised by the US and Argentina and refer to our past statements on this STC. 
We kindly ask the EU to share any updated information related to the  use of regulated terms for 
wines exported to the EU in Regulation (EC) No. 607/2009 and Council Regulation (EC) No 479/2008.  
1.122.   The delegation of New Zealand  provided the following statement. New Zealand supports 
concerns raised by other Members.  New Zealand  recogni zes that Members have the right to protect 
 
28 For previous statements follow the thread under IMS ID  345 (under dates raised and references) . G/TBT/M/81  
 
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  their consumers from deceptive practices in line with their obligations under the WTO. New Zealand 
asks that the European Union takes into consideration concerns raised by Members relating to the 
scope and  application of the system of traditional terms, as well as transparency, process, and 
timelines relating to applications by third countries who wish to use traditional terms in the European 
Union.  
1.123.   In response, the delegation of the European Union  provided  the following statement. The EU 
understands the continued interest of the United States and other Members in this issue. The EU 
has completed the revision of its internal legislation on traditional terms which was discussed in 
previous TBT Committees (Com mission Delegated Regulation (EU) 2019/33 and Commission 
Implementing Regulation (EU) 2019/34). The EU believes that its internal legislation offers a 
meaningful and transparent system of protection to traditional terms used on wine products from 
the EU, a s well as on products from third countries. In the past, the EU has demonstrated its ability 
to address specific Members' concerns in this area either via its internal legislation or via bilateral 
agreements.  
1.3.3   European Union – Hazard -based approach to plant  protection 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/TBT/N/EU/166 , G/TBT/N/EU/166/Add.1 , 
G/TBT/N/EU/166/Add.1 , G/TBT/N/EU/263 , G/TBT/N/EU/495  (IMS ID 39329) 
1.124.   The delegation of Costa Rica  provided the following statement. Costa Rica would again like  
to reiterate its support for the trade concern raised by the United States, Panama, the  
Dominican  Republic and Ecuador.  As we have stated on numerous occasions during this Committee's 
previous meetings, we are concerned about the hazard -based approach tak en by the European Union 
(EU). We again urge the EU to ensure that the implementation of its regulations is based on the use 
of risk assessments through the application of criteria supported by sufficient scientific evidence, in 
line with the commitments e stablished in the Technical Barriers to Trade (TBT) Agreement.  
1.125.   The delegation of the United States  provided the following statement. The United States 
reiterates concerns on endocrine disruptors, which many WTO Members have expressed at previous 
TBT Commit tee meetings without any satisfactory response from the E U. The EU has stated that it 
will conduct risk assessments for MRLs and import tolerances for substances triggering its hazard 
criteria; however, this does not appear to be the case. The E FSA does no t set risk endpoints even 
for substances for which other authorities, including C ODEX , have successfully completed risk 
assessments and set MRLs. Through its hazard -based approach, the EU continues to restrict the use 
of pesticides and to lower MRLs to tra de-restrictive levels. The EU has stated its commitment to 
transparency, but it has yet to clarify the legitimate objective that the EU is seeking to achieve or 
its relationship to the risk of non -fulfilment. As we conveyed previously, we have serious conc erns 
about the scientific underpinnings, non -discrimination, transparency, and predictability in application 
of the EU's process. We ask the EU for a date when it will respond to our questions, with clarity and 
specificity, so that this Committee might gai n a better collective understanding of how the EU is 
regulating pesticides and establishing MRLs in a manner consistent with its WTO obligations.  
1.126.   The delegation of Panama  provided the following statement. Article 2.2 of the TBT 
Agreement clearly states tha t: "Members shall ensure that technical regulations are not prepared, 
adopted or applied with a view to or with the effect of creating unnecessary obstacles to international 
trade. For this purpose, technical regulations shall not be more trade -restrictive  than necessary to 
fulfil a legitimate objective, taking account of the risks non -fulfilment would create." We note 
however that the EU's measures surpass the requirements for fulfilling its purposes, especially where 
they deviate from the guidelines set b y the Codex  Alimentarius and other international organizations 
under the premise that the studies were inconclusive.  Paragraph 7.3 of notification G/TBT/N/EU/625  
on the non -renewal of chlorothalonil states that no conclusive results could be reached. Rather than 
using the principle o f risk, as required by the Sanitary and Phytosanitary (SPS) Agreements, this is 
clearly using the principle of hazard. The principle of hazard has also been used in the EU's other 
notifications submitted to the SPS and TBT  Committees with reference to othe r substances. We 
should like to recall that Article 3 of the SPS Agreement states that Members must endeavour to 
harmonize their measures to improve the predictability of trade. Article 3 .4 also states that they 
must rely on the relevant international organizations.  While every Member is free to take the 
necessary precautions to ensure the safety of its citizens, such measures must not be so needlessly 
 
29 For previous statements follow the thread under IMS ID  393 (under dates raised and references) . G/TBT/M/81  
 
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  stringent that they adversely affect trade. In addition, conclusive scientific evidence must be used 
as a basis, as stipulated in Article 5 of the SPS  Agreement. We are concerned that the EU's studies, 
which proved inconclusive, have led to the restriction on active substances, whose use is permitted 
and regulated by international bodies and is essential in the rest of the world.  
1.127.   The substance, chlorothalonil, is an organic compound that is crucial to fighting diseases in 
plantain and banana crops such as black Sigatoka, caused by the Mycosphaerella fijiensis  (Morelet) 
fungus. Black Sigatoka v isibly attacks the banana and plantain plants, presenting as black spots on 
the leaves. It later halves plant production, and then in most cases, destroys 100 % of sales of the 
fruit. The disease is aggravated by global warming and by rain and humidity, cli matic phenomena 
observed all year in tropical countries; quite different from the climates of Stockholm or Madrid. 
Panama has already had to fight this fungus in the past, insomuch as black Sigatoka was known as 
the "Panama disease" in many parts of the wo rld. We should like to point out that it first appeared 
in Fiji, however. Phytosanitary measures enabled us to fight it successfully. Nevertheless, we are 
again under threat in 2020, with the beginning of restrictions on inputs and the highest recorded 
temperatures worldwide.  Alternatives to chlorothalonil are substances such as mancozeb, which the 
EU also announced as non -renewable in notification G/TBT/N/EU/712 . That notification specifically 
cited studies on tomatoes, potatoes, cereals and grapevines - fruits with flesh less thick than that of 
bananas. The substance was again restricted despite a lack of scientific evidence on all the products. 
Let us recall that, unlike tomatoes, grapes and potatoes, banana peels is not to be consumed. 
Separate studies should therefore be conducted  on this type of product taking account of its 
differences. The fruit is also carefully washed and sanitized in Panama's banana packing plants in 
line with safety protocols.  
1.128.   These EU measures could seriously harm the well -being and employment of  thousands of 
families belonging to the Ngäbe Buglé indigenous people, the main source of labour for the banana 
plantations of Changuinola and Puerto Armuelles. In 2017, the trade in bananas between Panama 
and the European Union exceeded 17  million boxes, equivalent to USD 180 million, bananas being 
the main income -producing product in the region. Should this activity be affected it would also set 
back the country's struggle to improve its production and combat climate change.  In terms of 
transition periods, the EU re fers to six -month periods. However, banana production typically takes 
between 9 and 12 months, besides the fruit's transit time from origin to destination and finally to 
the point of sale. To put it another way, the process to adjust the crop to the new me asures could 
lead to over a year's losses in production.  
1.129.   On 12  May 2020, Panama and a dozen other Members presented document G/TBT/GEN/296 , 
requesting Members to suspend the entry into force of the new MRLs for plant protection products 
during the coronavirus disease (COVID -19) pandemi c. We would be grateful to the EU for showing 
solidarity and addressing this request on a temporary basis. Meanwhile, we can continue our 
dialogue on how the EU can implement health measures in compliance with the SPS and 
TBT Agreements, without unjustifia bly preventing international trade. Nonetheless, we choose to 
seek solutions that enable all Members to assist each other with the harmonization of our legislation, 
in order to safeguard human, animal and plant health, without imposing unnecessary and unil ateral 
trade barriers.  
1.130.   The delegation of the Dominican Republic  provided the following statement. 
The Dominican  Republic thanks the United States for including this agenda item once again, and we 
agree with the other delegations' statements on this matter.  We should again like to express our 
concern concerning the EU's ongoing measures, since this concern is both trade -related and 
systematic. The EU has chosen to base these measures on potential hazard rather than on 
science -based risk assessment, in restri cting the use of pesticides and reducing MRLs for import 
tolerances.  These measures are having serious socio -economic consequences in the region, given 
their impact on the production of agricultural products that producing countries export to the EU. 
Reduc ing MRLs to restrictive levels generates negative and unnecessary effects on international 
trade.  We therefore request the EU to avoid implementing this type of unnecessary trade barrier, 
particularly given the importance of the EU's market to developing c ountries, including 
the Dominican Republic, and that such regulations be applied on the basis of sound scientific 
evidence.  
1.131.   The delegation of Ecuador  provided the following statement. Ecuador notes with concern the  
EU's continued reduction in the number of  plant protection substances authorized in its territory, 
solely based on the hazard criteria established in its legislation on endocrine disturbers, and without G/TBT/M/81  
 
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  a risk assessment to establish appropriate MRLs for those substances.  During the MRL review 
process, the European Food Safety Authority (EFSA) published inconclusive reasoned opinions, 
based on a lack of information. Despite this lack of information, the EU is reducing MRLs to the 
minimum detection levels, definitively rather than provisionally, wh ich is bringing about a restrictive 
effect on trade.  Consequently, it is necessary to request that the EU ensure its adopted measures 
are grounded on conclusive scientific findings, in line with the WTO Agreements, thereby providing 
its trading partners wi th more predictability and transparency throughout the process.  Where 
information is lacking, we would again request the EU to ensure the EFSA does not issue any MRL 
recommendations and that the current level be maintained to avoid affecting trade, wheneve r 
decisions on regulatory measures are to be supported by conclusive risk assessments that genuinely 
offer health protection, and avoid creating unjustified technical barriers to trade.  
1.132.   The delegation of Colombia  provided the following statement. Colombia thanks the  
delegations that have included this item on the agenda and again reiterates its concern with respect 
to the EU's approach to identifying substances with endocrine -disrupting and carcinogenic 
properties.  We highlight the need to use risk assessme nt as a methodological tool for making 
decisions under its three components of assessment, management and communication. A review of 
the EU's proposal shows that risk assessment is losing ground, with the decision to accept or allow 
the use of substances b eing made under a hazard -based approach and neglecting the conditions of 
use that can define risk scenarios and lead to scientifically -based decisions.  In light of the above, 
Colombia considers that the EU proposal must take into account scientific evidenc e, production 
processes and methods, the international recommendations of the Codex  Alimentarius, and the 
relevant ecological and environmental conditions in countries that may be affected by the 
implementation of the measure, in order to avoid creating an  unnecessary technical barrier to trade.  
1.133.   The delegation of Paraguay  provided the following statement. The delegation of Paraguay  
wishes to express its support for the trade concern raised by various delegations under this item.  It 
is truly concerning that the European Union has taken a series of decisions not to renew the approval 
of substances and to amend the MRLs of those substa nces, without considering risk assessments or 
ensuring compliance with the Codex Alimentarius standards, especially since, due to the lack of 
assurance as to import tolerance, we are facing a situation in which the EU would appear to be 
effectively imposin g the adoption of its standards on its trading partners.  As we stated at the last 
session of this Committee, and in the SPS Committee, we consider that the use of a hazard -based 
approach for the regulation of these substances will result in unnecessary bar riers to trade and will 
adversely affect our producers. Conservative estimates put the trade damage for my country at over 
EUR 850 million, due to the effective or probable non -renewal of several substances that have 
already been or are about to be reviewe d by the EFSA. This economic damage will adversely 
affect  thousands of small producers whose livelihoods depend on agriculture and who already face 
numerous barriers and difficulties as a result of other protectionist measures and distortions in 
agricultur al trade, climate change and the price depression on the international market.  In addition 
to these problems are the negative economic impacts of the COVID -19 pandemic, which will 
particularly affect developing countries, which have fewer resources to prov ide stimuli to help our 
economies recover and for most of whom agriculture is the main economic driver.  We again urge 
the European Union to perform full risk assessments, avoid unnecessary trade restrictions, and 
provide reassurance for Members regarding t he policy on import tolerances that will be applied.  
1.134.   The delegation of Guatemala  provided the following statement. We thank Costa  Rica, 
the United  States, Panama and the Dominican Republic for including this item on the agenda. 
Guatemala reiterates its con cern regarding the matter of endocrine disrupters and the hazard -based 
approach. The importance of the risk analysis framework needs to be recognized. This includes risk 
assessment, risk management and risk communication.  The precautionary principle is jus tified when 
potentially negative effects are identified, the available scientific data is assessed and scientific 
uncertainty grows.  We would like to reiterate the importance of using risk analysis for import 
tolerances, particularly for tropical developin g countries, whose climatic conditions differ from those 
of the EU in that we do not have a harsh winter to help control pests.  Geographical location, namely, 
the distance and time needed to export a product to the EU, is another factor that should be take n 
into consideration to avoid applying measures that unnecessarily restrict trade.  
1.135.   The delegation of Brazil  provided the following statement. Brazil would like to refer to its 
past statements regarding STC ID 393. The  EU has systematically refused to take into account 
concerns raised by many WTO Members regarding notifications G/TBT/N/EU/383  and 
G/TBT/N/EU/384 . We emphasize that regulations on endocrine disruptors should be established G/TBT/M/81  
 
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  according to sound scientific principles, taking all available data into consideration. Serious 
evaluations must be able to sepa rate chemicals that have the potential to cause harm due to their 
endocrine mode of action from those substances that do not pose a threat to human health. The 
European approach to limit the use of pesticides is more trade restrictive than necessary to ful fil its 
legitimate objectives under the TBT Agreement. It also disregards risk analyses in the setting of 
regulatory measures that may have serious impact on trade.  
1.136.   The delegation of Uruguay  provided the following statement. Uruguay would like to thank  
the United  States, Panama, Costa Rica and the Dominican Republic for again including this specific 
trade concern on the Committee's agenda.  We would like to support the other Members' comments 
and reiterate our trade and systemic concern relating to the EU's use of a hazard -based approach, 
instead of full scientific risk assessments, when making its regulatory decisions concerning 
phytosanitary products and when setting import tolerances for substances that meet the cut -off 
criteria.  As we have stated previously, evidence based on the assessment of the actual risks 
associated with phytosanitary products must play a key role in regulatory decision -making. If not, 
some of these products might be withdrawn despite their safe use as components of the pest 
management system. An approach based on hazard rather than on actual risk could have a negative 
and disproportionate impact on sustainable agricultural production, food security and international 
trade in food products, contributing little or nothing to the  cited aim of protecting public health.  
Uruguay continues to support any multilateral work undertaken by the Codex Alimentarius to 
develop a harmonized, risk -based approach for substances with endocrine -disrupting properties that 
ensures the protection of health while facilitating international trade in food products. In the 
meantime, we once again urge the EU to give due consideration to the concerns expressed and to 
reconsider its regulatory approach, with a view to preventing the unjustified proliferatio n of barriers 
to international trade in agricultural products and the serious social and economic consequences of 
such an approach for other Members, in particular developing and least developed countries, for 
whom this is an important market.  
1.137.   The delegati on of Canada  provided the following statement. Today more than ever, safe and 
sustainable agricultural practices, including the use of plant protection products, must not be 
overlooked as an effective way to achieve food security. Ensuring access to safe a nd nutritious food, 
especially during these uncertain times, is paramount. As stated during past TBT Committees, 
Canada is concerned with the EU's approach to decision -making for plant protection products, and 
particularly the impact of these decisions on trade of agricultural commodities and setting of import 
tolerances. Canada is keen to understand how the procedures laid down in Regulation (EC) 
No. 396/2005 will be implemented to manage import tolerance requests for active substances falling 
under the ha zard-based cut -off criteria. It also remains unclear whether the EU will take into 
consideration assessment techniques developed by relevant international organizations. We 
welcome the EU's commitment to host seminars with third countries and stakeholders.  We recognize 
that timelines to hold these sessions may have been temporarily disrupted due to the current global 
pandemic, but we look forward to participating in this information exchange when circumstances 
permit. We trust that these events will provide  sufficient detailed information to clarify and address 
our concerns.  
1.138.   In the meantime, Canada would welcome any additional information that will help ensure 
predictability of trade, as non -renewal decisions are currently in the process of being implemented  
by the EU. Until a clear and predictable process for setting import tolerances is implemented, MRLs 
for active substances, which are not re -authorized in the EU, should be maintained at existing levels 
to allow trade to continue. Finally, Canada looks for ward to learning more about the EU Farm to Fork 
and Biodiversity strategies, which we understand will be made public on 20 May, with implementing 
measures over the course of the next year. We look forward to continuing our engagement with the 
EU and hope t hat regulatory changes arising from any new policy will be implemented in a coherent 
and transparent way that will minimize unnecessary barriers to trade and provide sufficient time to 
allow producers and exporters to make timely business decisions.  
1.139.   The de legation of Australia  provided the following statement. Australia reiterates its position 
from previous meetings about the importance of adopting a science and risk -based approach for 
regulating plant protection products rather than considering only the po tential for harm (hazard) 
due to the intrinsic properties of a chemical. Australia notes that the European Union has recently 
made several pesticide non ‑renewal decisions and subsequent changes to relevant MRLs which are 
impacting Australia's and others ' trade with Europe. Australia is concerned about the significant 
uncertainty surrounding the mechanisms for setting import tolerances, including for substances G/TBT/M/81  
 
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  falling under the hazard cut -off criteria of Regulation (EC) No 1107/2009. We understand that the 
European Commission is currently in the process of updating its procedures for handling requests 
for import tolerances and would appreciate any updates on the timeframe for the finali zation of such 
work.  
1.140.   Australia would welcome the release by the EU of gui dance material on the procedures for 
handling requests for import tolerances and information sessions with third countries and 
stakeholders providing details on the import tolerance setting process. These initiatives should be 
implemented as a matter of pr iority to provide trading partners with clarity and predictability about 
the outcomes of their requests for import tolerances. Until a clear and predictable process for setting 
import tolerance is implemented, Australia requests that MRLs for active substa nces which were not 
renewed in the EU be maintained at existing levels to minimize trade disruption and allow producers 
and exporters to make timely business decisions. Alternatively, Australia requests the setting of 
temporary MRLs in order to allow any s cientific studies necessary for supporting an MRL to be 
undertaken and evaluated. We thank the EU for its on -going  engagement with Australia on these 
issues and look forward to continuing our constructive engagement.  
1.141.   In response, the delegation of the European Union  provided the following statement. The 
European Union would like to thank the WTO Members for their interest in the on -going  work in the 
EU on identifying endocrine disruptors for plant protection products. As informed in previous TBT 
Committee m eetings, the scientific criteria to identify endocrine disruptors for plant protection 
products based on the WHO definition are applicable since 10 November 2018 onwards and included 
in Regulation (EU) No 2018/605. The European Union is aware of general co ncerns on the EU policy 
on plant protection products for the definition of scientific criteria to identify endocrine disruptors. 
The European Union is also aware of more specific concerns, in particular, on whether import 
tolerances can be established for substances that are not authori zed in the EU, due to the so -called 
"cut-off" criteria in Regulation (EC) No 1107/2009.  
1.142.   After having examined the different policy options and taking into account the concerns 
raised by stakeholders, member States and third c ountries, the European Union confirms that it has 
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. These 
procedures include a risk assessment by an evaluating EU member State and a scientific opinion by 
the E FSA. The granting of the import tolerance will then be considered in line with risk analysis 
principles on a case -by-case basis and taking into account all relevant  factors. The EU reiterates its 
commitment to act in full transparency and will keep Members duly informed about further 
developments.  
1.3.4   China – Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1313  (IMS ID 42830) 
1.143.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as follows. As mentioned during the previous TBT 
Committee meeting, Korea requests that China: (i) recognize intern ationally accredited laboratories 
or overseas laboratories as certified laboratories for medical devices; and (ii) provide equal 
treatment to domestic and imported products in terms of the importation and sales of used medical 
devices. Furthermore, we hope  to soon receive replies to our comments and request China to share 
the expected timeline for the implementation of the regulation and provide a sufficient transition 
period to avoid creating confusion among medical device exporters.  
1.144.   In response, the deleg ation of China  provided the following statement. The Regulation for 
the Supervision and Administration of Medical Devices, which was adopted in 2014, has further 
simplified the requirements for registration of medical devices. Firstly, to set up and improv e the 
classification management system. Based on the different levels of risks, the medical devices are 
divided into three categories. The requirements for low -risk products are further streamlined. 
Secondly, to lower the requirements on clinical trials. C ertain products are exempted from clinical 
trials. Thirdly, to simplify the re -registration requirements. In an implementation notice following 
the Regulation, one -year transition period and some other transitional measures have been 
provided. In September  2018, National Medical Products Administration published a new revised list 
for medical devices exempted from clinical trials; in total, 1 ,248 medical devices are exempted from 
 
30 For previous statements follow the thread under IMS ID  428 (under dates raised and references) . G/TBT/M/81  
 
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  clinical trials. For the repeated testing problem raised by Members, China Food and Drug 
Administration released the Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical 
Devices in January 2018. The Guidelines provide guidance for accepting overseas clinical trial data 
as clinical evaluation materials.  It helps to avoid and decrease the repetition of clinical trials, 
accelerating the market access of medical devices.  
1.3.5   China – Cyberspace Administration of China – Draft implementing measures for the 
Cybersecurity Review of Network Products and Services ( IMS ID 53331) 
1.145.   The delegation of the European Union  provided the following statement. The EU has raised 
the Security Review of Ne twork Products and Services, including the Cybersecurity Review Measures, 
in this Committee on several occasions, stressing our concerns related to these measures. The EU 
also submitted written comments last year to the public consultation. We understand t hat these 
Review Measures will now enter into force on 1 June. We remain concerned that the measures are 
quite general and very broad discretionary powers are left to the authorities in charge of the security 
review, raising concerns for foreign ICT operat ors. The EU urges China to ensure the clarity, 
transparency and objectiveness of the security review so that the measure does not  become a new 
market access barrier. The EU is concerned that the Measures do not specify methodologies and 
standards to be use d during the review. Critical Information Infrastructure (CII) operators will be 
obliged to conduct a preliminary risk assessment and form a report when purchasing network 
products and services, and to apply for a cybersecurity review under circumstances a ffecting national 
security, however some of the elements appear to be quite wide in scope and open -ended. We also 
note that the non -technical factors among the cybersecurity review have been retained in the final 
version and would be interested in understa nding how China plans to assess these factors, bearing 
in mind that, from a business perspective, predictability is very important.  
1.146.   We note Article 16 ensuring confidential business information protection, but at the same 
time, Article 18 stresses oversigh t by the Review Office through reports and other means. We 
reiterate the importance that the EU attaches to the protection of all IPR and confidential business 
information in this review process and its follow -up steps. Finally, the EU would like to unders tand 
how the cybersecurity review will validate new contracts. The measure appears to make the 
cybersecurity review a market access condition, to a certain extent. For network product and service 
procurement activities that need to undergo the cybersecurit y review, the CII operators should 
specify, in the procurement documents or the contracts or via other binding means, the obligation 
of the product and service providers to cooperate with the cybersecurity review, and that contracts 
should only take effect  after the cybersecurity review is passed (Article 6). We would appreciate 
clarifications to these and to our previous questions from the Chinese delegation in order to make 
sure that we have the correct reading of the situation.  
1.147.   The delegation of Japan  provided the following statement. Japan has its interest in and 
concern with regard to the Cyber Security Review Measures and would like to refer to the previous 
statement we made at the last TBT Committee in February 2020. We recognize that the measures 
will entry into force on 1 June 2020. Japan would like to request China that the measures would be 
implemented transparently and in full consideration of the comments and concerns raised by Japan 
and other Member s. 
1.148.   The delegation of Canada  provided the follow ing statement. Canada notes that the final 
Measures for Cybersecurity Review were promulgated on 13 April 2020, will enter into force 49 days 
later on 1 June 2020 and that a 2001 WTO Ministerial Decision set this period at six months, unless 
this would be ineffective in fulfilling the legitimate objectives pursued by the measure. Canada kindly 
requests China provide a rationale for the 49 -day entry into force period. Canada's understanding is 
that the cybersecurity law, that the measure implements, defines CII as: public communications and 
information services, power, traffic, water, finance, public service, electronic governance and all 
other information infrastructure which, if destroyed, damaged or subjected to data leaks, could 
endanger national security , national welfare and the people's livelihood, or the public interest. As 
the measure applies to operators of this infrastructure, but does not further define it, could China 
please provide more information on what CII is so that the legitimate objective of the measure can 
be clarified and operators can be provided with more certainty?  
 
31 For previous statements follow the thread under IMS ID  533 (under dates raised and references) . G/TBT/M/81  
 
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  1.149.   The final version of the measure requires operators of CII to create a report on the potential 
security threat of a planned purchase of a good or service, however, the crite ria they are to use in 
assessing security, that were in previous versions of the measure, have been removed instead of 
clarified. Could China please describe the criteria operators are to use in assessing a security threat 
and how they relate to legitimate  objectives under the TBT Agreement?  Article 3 of the measure 
sets out its broad objectives. Would it be possible for China to add the following TBT Agreement 
obligations: National Treatment, MFN treatment and the use of international standards? In Article  4, 
the measure states that: "The cybersecurity review office, which will be established at the 
Cyberspace Administration of China, will be responsible for formulating the relevant systems and 
norms for cybersecurity reviews … " Could China please explain w hen these norms will be published 
and notified to the TBT Committee?  
1.150.   In response, the delegation of China  provided the following statement. To adapt to the 
increasingly severe network security situation, protecting national network security, especially 
supply security of critical information infrastructures, drawing on international practices, 
Cybersecurity law requires to set up a cybersecurity review mechanism. Cybersecurity Review 
Measures is to implement Cybersecurity law and will enter into force on 1 June 2020. Measures for 
security review of network products and services will be abolished. Cybersecurity review mechanism 
is not to restrict nor discriminate against foreign products and services. Opening  up is one of China's 
basic state policies, China w elcomes foreign products and services to enter Chinese market on the 
premise of observing Chinese laws.  
1.3.6   European Union – Transitional periods for MRLs and international consultations 
(IMS ID 58032) 
1.151.   The delegation of the United States  provided the following statement. The United States 
thanks Colombia for again raising this issue. We share the concern that the EU's transition measures 
do not provide adequate time for producers to modify their pest management program mes to clear 
the channels of trade. Furtherm ore, the EU's policies appear to establish arbitrary differences in the 
treatment of domestic and imported products, and do not appear to account for obstacles posed to 
imported products compared with generally non -existent risks of non -fulfilment with the ir described 
legitimate objectives of human health and safety. Since the last meeting of the TBT Committee, the 
EU has begun to notify its active substance non -renewal  decisions to both the TBT and SPS systems. 
However, this does not adequately address the  inherent problems with the EU's approach to 
regulating crop protection products and establishing MRLs.  
1.152.   Trading partners still do not know with certainty the impact of the non -renewal  decision on 
future MRLs, nor can foreign growers make informed decision s on their food production practices in 
the present. Foreign growers who comply with existing EU MRL standards at the time of production 
continue to face possible rejection at EU borders – a damaging prospect that EU growers do not face 
under the current r egulatory provisions. The EU has acknowledged that non -EU countries have a 
shorter time to comply with new MRLs compared to EU member States, but it has not clarified how 
such shorter timeframes do not arbitrarily or unjustifiably discriminate between its own territory and 
that of other Members. Once again, the United States reiterates our request that the EU conduct full 
risk assessments prior to resetting MRLs, and we ask that the EU extend its MRL transitional 
measures to account for realistic production  and processing times for food and agricultural products.  
1.153.   The delegation of Panama  provided the following statement. Through this communication, 
Panama will address the concerns about STC ID 393: Hazard -based approach to plant protection 
products and setting of import tolerances; STC ID 580: European  Union - Transitional periods for 
maximum residue limits (MRLs) and international consultations; and STC ID 579: European  
Union - Chlorothalonil (pesticide ac tive substance). Article 2.2 of the TBT Agreement clearly  states 
that "Members shall ensure that technical regulations are not prepared, adopted or applied with a 
view to or with the effect of creating unnecessary barriers to international trade. For this purpose, 
technical regulations shall not be more trade -restrictive than necessary to fulfil a legitimate 
objective, taking account of the risks non -fulfilment would create". However, we note that the 
measures taken by the European Union go beyond what is n ecessary to achieve their aims, especially 
when these deviate from the guidelines of Codex and other international organizations under the 
premise of inconclusive studies.  
 
32 For previous statements follow the thread under IMS ID  580 (under dates raised and references) . G/TBT/M/81  
 
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  1.154.   In its notification G/TBT/N/EU/625  for the non -renewal of chlorothalonil, paragraph 7.3 
states that no conclusiv e results were found. This is clearly the use of the principle of hazard, rather 
than of risk, as is required in the SPS Agreements. Similar cases of the use of the principle of hazard 
have appeared in other EU notifications of other substances submitted t o the SPS and TBT 
Committees. We take this opportunity to recall that Article 3 of the SPS Agreement states that 
Members should try to harmonize their measures to improve the predictability of trade and, pursuant 
to Article 3.4, they should draw on the sup port of the relevant international organizations.  While 
every Member is free to take necessary precautions for the safety of its citizens, these measures 
should not be unduly strict to the point of adversely affecting trade. In addition, there must be 
conclusive scientific evidence, as stipulated in Article 5 of the SPS Agreement. It is of concern to us 
that inconclusive European Union studies have resulted in the blocking of active substances, the use 
of which is permitted, regulated by international insti tutions and essential in the rest of the world.  
1.155.   The substance chlorothalonil, specifically, is an essential organic compound for fighting 
disease in plantain and banana crops, such as black sigatoka, caused by the fungus Mycosphaerella 
fijiensis Morelet . Black sigatoka initially attacks plantain and banana plants visibly, presenting as 
black spots on the leaves; it later halves plant production, and then in most cases it destroys 100 % 
of sales of the fruit.  This disease worsens with global warming, rain and  humidity, which are climatic 
events observed 365 days of the year in tropical countries, a climatic situation that is quite different 
from that found in Stockholm or Madrid. Panama has already had to fight this fungus before, to the 
point where in many pa rts of the world black sigatoka was known as the Panama disease, although 
we always point out that it first appeared in Fiji. It was thanks to phytosanitary measures that we 
were able to fight it successfully; however, we are again at risk in 2020, with in puts in use beginning 
to be blocked and the Earth's highest temperatures being recorded.  
1.156.   Alternatives to chlorothalonil are substances such as mancozeb, the non -renewal of which 
the EU also declared in its notification G/TBT/N/ EU/712. Studies involving tomatoes, potatoes, 
cereals and  grapes, and all fruit with pulps of lesser thickness than bananas, are specifically 
mentioned in this notification. Yet again, without obtaining scientific evidence on all products, the 
substance has been blocked. We recall that, unlike with tomatoes, gra pes and potatoes, the peel of 
a banana is not consumed; individual studies should therefore be made into this type of product, 
taking account of its differences. Furthermore, in Panama's banana packing plants, this fruit is 
carefully washed and sanitized f ollowing food safety protocols.  
1.157.   The European Union measures could cause heavy losses and threaten the well -being and 
employment of  thousands of families belonging to the Ngäbe Buglé ethnic group, who are the main 
source of labour for the banana plantations  of Changuinola and Puerto Armuelles. In 2017, the trade 
in bananas between Panama and the European Union exceeded 17  million boxes, equivalent to 
USD 180 million, bananas being the main income -producing product in the Ngäbe Buglé region. 
Moreover, any imp act on this activity would mean a step backwards in the country's struggle to 
improve its production and combat climate change.  In reference to transition periods, the European 
Union talks of periods of six months. However, banana production typically last s from 9 to 12 
months , without taking into account the transit time for fruit from origin to destination and finally to 
the point of sale. In other words, during the process of adapting cultivation methods to the new 
measures, losses amounting to more than  a year's production could be generated.  
1.158.   On 12 May 2020, Panama, together with a dozen other Members, submitted document 
G/TBT/GEN/296 , requesting Members to suspend the entry into force of the new maximum residue 
limits for plant protection products during the COVID -19 pandemic. We th ank the European Union 
for being supportive and responding to this request on a temporary basis. During this time, we can 
continue discussions on how the EU can take health measures in line with the SPS and 
TBT Agreements without unduly interrupting intern ational trade. However, our choice is to seek 
solutions that would allow all Members to support each other in harmonizing our legislation, with the 
aim of safeguarding human, animal and plant health without imposing unnecessary unilateral 
barriers to trade . 
1.159.   The delegation of Costa Rica  provided the following statement. As in previous meetings,  
Costa  Rica associates itself with the concern raised by the United States, Colombia, the 
Dominican  Republic, Ecuador and Panama, as well as with the request for extension of the period 
for compliance with the new tolerances that are being established for various substances, in view of 
the serious impact that they have on the agricultural production of our countries.  The EU's review 
of the tolerances for various su bstances used in agricultural production is a source of huge concern G/TBT/M/81  
 
- 42 - 
 
  for Costa Rica. As previously stated, it is impossible for agricultural production to adjust to new 
requirements or tolerances within six months, when the registration of new molecules al one must 
undergo a complex assessment process lasting much longer than that period.  
1.160.   Furthermore, in the current historical context in which the international community finds 
itself due to the COVID -19 crisis, the implementation of certain sanitary and phyt osanitary measures 
that create additional restrictions or burdens on international trade in animals, plants or plant 
products constitutes a challenge that is hampering worldwide economy recovery efforts, especially 
in developing countries.  In this regard, we would like to reiterate the request made in document 
G/SPS/GEN/1778  and G/TBT/GEN/296  – Request  for the Suspension  of the Processes and Entry Into 
Force of Reductions of Maximum Residue Levels (MRLs) for Plant Protection Products in Light of the 
COVID -19 Pandemic . 
1.161.   The delegation of the Dominican Republic  provided the following statement. The 
Dominican  Republic wishes to reiterate its concern with respect to this agenda item and associates 
itself with the statements of other countries regarding international consultation processes and the 
transition periods gran ted by the European Union prior to the entry into force of provisions under 
which the EU no longer approves the marketing of certain pesticide substances and amends 
maximum residue limits (MRLs).  In view of harvest times and the time needed to establish 
molecules, it is virtually impossible for farmers to be able to find control measures that are reliable 
enough to replace the molecules, owing to the long process required to obtain substitutes. For this 
reason, these measures will not provide enough time to  amend pest management programmes.  This 
results in significant losses for producers, leading to a direct impact on exports from countries like 
the Dominican Republic to the EU, especially in cases where even more time is needed to fine 
alternative substanc es, when it is normally necessary to wait for ideal production cycles to apply and 
adapt to measures.  We request the EU to extend its transition periods and to consider the need to 
use risk analysis as a methodological tool for developing standards in orde r to facilitate international 
trade, taking into account a more realistic approach to agricultural production times, closely following 
crop production stages.  
1.162.   The delegation of Colombia  provided the following statement. Colombia wishes to reiterate  
its gra ve concern regarding international consultation processes adopted and the transition periods 
granted by the European Union prior to the entry into force of provisions under which the EU no 
longer approves the marketing of certain plant protection substance s and amends maximum residue 
limits (MRLs).  These concerns are being reiterated because, to date, there is no alternative that 
would help resolve the problems that short transition periods cause for fruit and vegetable producers 
in Latin America. In this c ontext, we reaffirm the arguments put forward and compiled in document 
G/TBT/W/695  of 13  November  2019.  In accordance with the provisions of Articles 2.5 and 2.12 of 
the TBT Agreement, Colombia considers that there should be further discussions at the technical 
level, with the participation of the Members concerned and taking into consideration the arguments  
and technical, scientific and economic evidence, to review the time periods for bringing into force 
the regulatory changes to MRLs, taking into consideration international consultation forums, in order 
to prevent them from becoming unnecessary barriers to  trade.  
1.163.   The uncertainty faced by agricultural producers related to short transition periods raises 
concern. These measures create additional burdens for producers, who need to make decisions on 
the use of crop protection products a year or more before the final product arrives on the European 
market.  This is particularly complex for products with long production, harvest, storage and 
distribution cycles. The same challenges arise in processed and frozen foods. For such products, 
short transition periods can  create situations in which imported products are discriminated against 
in favour of domestic products, as goods produced in accordance with the EU standards in force at 
the time of production may no longer be eligible to enter the EU by the future date on  which they 
arrive at the border.  Moreover, the situation arising from the COVID -19 global health emergency 
has forced the health and scientific authorities of all countries, including Colombia, to focus attention 
on that crisis. By the same token, key sec tors such as food producers, organizations and associations 
are having to make significant efforts to ensure biosecurity controls in the fruit and vegetable supply 
chain. This is reducing their capacity to analyse draft regulatory measures and adjust produ ction 
methods, creating additional burdens on international food trade, which is hampering worldwide 
economy recovery efforts, especially in developing countries.  
1.164.   In line with the statements made in communication G/TBT/GEN/296  of 12 May,  we request 
the EU to suspend for a period of 12 months all review processes of market approvals for plant G/TBT/M/81  
 
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  protection substances, the processes currently under way to establish new MRLs, and the entry into 
force of regulations in these areas, planned for 2020.  Furthermore, Colombia maintains that 
notific ation of transition periods or MRLs to the WTO should not be conducted as a simple formality 
within the regulatory process, but should provide a real forum for Members to submit substantive 
observations and comments for genuine consideration by the Committ ee that could lead to 
adjustments to proposed regulations.  Therefore, within the framework of this Committee, we do not 
believe it is enough for the European  Union to state that as soon as the EFSA recommendation and 
PAFF Committee opinion are known, count ries should be able to "predict and make the relevant 
adjustments", given that this information has not been notified to the WTO and therefore the public 
consultation period has not expired.  Colombia once again welcomes the opportunity to express its 
conce rns on this issue and looks forward to a response from the European Union.  
1.165.   The delegation of Ecuador  provided the following statement. Ecuador reiterates its concern  
about the transition periods granted by the EU for implementing its measures relating to t he 
non-renewal of the use of substances and the reduction of MRLs, as they fail to provide sufficient 
time for producers to adapt without affecting their access to the European market . Farmers need 
more time to adapt to MRL requirements because it takes 36 months  on average to develop a new 
phytosanitary pest control product.  In order to establish reasonable transition periods, it is also 
necessary to consider harvesting periods and the times when agrochemicals need to be applied to 
ensure they are effectiv e. In addition, the time it takes from the time producers plan their harvest 
to the time it reaches European borders must be considered.  Our farmers are making the necessary 
efforts to comply with the EU's requirements because they cannot afford to lose th eir access, but it 
is physically impossible in such a short period of time. This is particularly true in the context of the 
COVID -19 pandemic, which has had a devastating impact on Ecuadorian society and has depleted 
the resources of our producers, especia lly the smallest producers.  We therefore once again urge the 
European Union to consider a period of at least 36 months, which would be a more suitable period 
to make the necessary adjustments in production and would enable developing countries to ensure 
compliance with the conditions laid down in the European regulations.  
1.166.   The delegation of Paraguay  provided the following statement. We wish to thank the 
delegations that included this topic in the agenda and express our support for this trade concern. In 
this regard, we consider that the length of the transition period granted for the implementation of 
amended MRLs is not sufficient fo r our producers to adjust production methods in order to adapt to 
these new standards, which we also consider run counter to harmonization because they do not 
conform to international standards. We are concerned that the European Union has been continuing 
with the process of reviewing substances with the consequent reductions of MRLs to the limit of 
detection in recent months, during which all Members have been affected by extraordinary 
circumstances that have affected our capacity to monitor and respond to  these measures, including 
being able to take part in the international consultation process, due to national efforts being 
primarily focused on fighting the COVID -19 pandemic. In this connection, Paraguay, together with 
12 other Members, circulated a comm unication addressed to the EU, but extended to all Members, 
requesting the suspension of the processes for reviewing and amending MRLs for plant protection 
products for a period of 12 months. This request was circulated under document symbols 
G/SPS/GEN/1778  and G/TBT/GEN/286 , and has arisen from the lack of capac ity at present to 
monitor the measures and exercise our rights effectively because, in addition to response capacity, 
the meetings and work of the delegations in Geneva have also been affected by the suspension of 
WTO meetings. We would greatly appreciate it if the EU would consider this request, in light of the 
extraordinary circumstances that all Members are experiencing and which we will continue to face 
in the post -pandemic recovery period.  
1.167.   The delegation of Guatemala  provided the following statement. We thank the United States,  
Panama, Costa Rica, the Dominican Republic and Colombia for including the topic in the agenda.  
Guatemala wishes to reiterate the importance of the European Union granting transition periods that 
closely follow the stages of crop production, in particular for crops grown in tropical countries. The 
productive sectors require a longer adaptation time, in particular to look for alternative substances, 
which in some cases means having to wait for suitable cycles in production to commen ce application 
and testing.  We are concerned that our ideas for discussions on finding solutions have not been 
heard and accepted. The trade concern on this issue focuses on safeguarding agricultural producers 
and exporters exporting to the European Union,  which will be affected by the European Union's 
change in conditions.  We would be grateful if the European Union could: (1) establish genuine 
dialogue to discuss this issue; (2) extend the transition period, with a view to ensuring that trade is 
not obstru cted any more than is necessary and giving time for tropical developing countries to adapt; G/TBT/M/81  
 
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  and (3) provide clarification on why our comments on this process in the WTO are not taken into 
account within the regulations.  
1.168.   The delegation of Uruguay  provided the following statement. Uruguay wishes to thank the  
United States, Colombia, Panama, Costa Rica and the Dominican Republic for including this item in 
the Committee's agenda.  In this regard, there is agreement that, in view of harvesting periods,  the 
stages at which plant protection products are applied, and the time required for the development 
and registration of alternative substances, the transition periods granted by the European Union in 
the provisions amending maximum residue limits (MRLs) for active substances do not give enough 
time to make the necessary adjustments to production and ensure that agricultural products comply 
with the new MRLs; even more so in the case of processed or frozen products.  Uruguay once again 
calls on the European  Union to adopt regulatory decisions based on internationally accepted 
standards or to provide conclusive scientific evidence when it is strictly necessary to depart from 
these standards in order to meet its legitimate objectives, as provided for in the re levant WTO 
Agreements.  Even in cases where the European Union decides, based on a comprehensive risk 
analysis, that it is necessary to reduce the MRLs for active substances used in the agricultural 
production of other Members, we encourage it to take into consideration the concerns expressed by 
various delegations regarding the insufficient length of the transition periods granted to make the 
relevant adjustments.  
1.169.   The delegation of Brazil  provided the following statement. Once again, Brazil would like to 
support the concerns raised by the U nited States, Colombia, Panama, Costa Rica and the Dominican 
Republic. We respectfully bring to the attention of the EU its obligations under Article 2.12 of the 
TBT Agreement, which relate to the establishment of a reason able interval between the publication 
of technical regulations and their entry into force, except in cases of urgent problems of safety, 
health, environmental protection or national security. It is of utmost importance to guarantee 
adequate intervals of tr ansition, especially for those cases in which the scientific opinions of the 
EFSA on the toxicity of substances are "inconclusive" or only indicate a "suspected risk". Last year, 
for instance, the EU defined a grace period of three months for accepting the  presence of MRLs for 
chlorpyrifos in the EU, following on TBT notification G/TBT/N/EU/682 . Such period is incompatible 
with the production period of an orange crop, when plants have already been sprayed with 
chlorpyrifos. It is also incompatible with the production process, given th at a significant part of the 
juice is exported frozen. This issue is especially important to small farmers, which had already used 
chlorpyrifos complying with EU regulations in force. In bilateral meetings, we have consistently tried 
to expand the transiti onal period for chlorpyrifos MRLs, but no progress has been achieved. 
Therefore, we urge the EU to provide a transitional period of at least six months, following on past 
decisions of this Committee.  
1.170.   The delegation of Canada  provided the following statemen t. Canada would like to reiterate 
its concern with the EU's transition periods for MRLs. Currently, transition periods do not apply to 
third countries, making it very difficult for exporters to adapt to the new requirements.  The current 
approach does not a cknowledge the reality of agricultural supply chains such as multi -year inventory 
and extensive shelf life, including in foreign countries.  At a time when ensuring food security is 
paramount, the EU's transition periods for MRLs must take into account the need for exporters to 
adapt to new requirements, as it has done for its domestic producers.  
1.171.   In response, the delegation of the European Union  provided the following statement. The EU 
thanks the WTO Members for raising this issue. As clarified in previous T BT Committees, as a matter 
of principle, the EU considers 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. Further to req uests by some Members, and in the interest of transparency, 
the EU has decided to notify all draft measures on pesticide active substances that are relevant for 
the TBT Committee additionally also to the SPS Committee. In practice, it means that future dra ft 
acts on the non -approval or restriction of approval of an active substance will be notified to both 
Committees. However, in the interest of efficient proceedings in both Committees, and in line with 
the respective Agreements, the EU continues to conside r that matters on approvals of active 
substances should be discussed exclusively in the TBT Committee and matters on the setting of 
MRLs for pesticides should be discussed exclusively in the SPS Committee.  
1.172.   The EU fulfils all its obligations under both the TBT and the SPS Agreement, including 
notifying its trading partners about planned measures that fall within the scope of either of these 
agreements. Information and comments received in response to these notifications are duly G/TBT/M/81  
 
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  considered and taken into acc ount before final decisions are taken, as explained in EU replies to 
trading partners. As regards possible transitional periods when MRLs are lowered, the EU would like 
to remind 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 is 
set. The date of application is the date from which the new/lower MRLs are effectively enforced. The 
length of the deferral is six months after en try into force, in the vast majority of cases. This deferral 
of the application date permits , inter alia , third countries and food business operators to prepare 
themselves to meet the new requirements that will result from the modification of the MRLs. Sec ond, 
products produced in the EU or imported into the EU before the aforementioned application date 
may continue to benefit from the old/higher MRLs and remain on the market, if information shows 
that a high level of consumer protection is maintained. This  is regularly not the case where MRLs 
are lowered because the safety of consumers could not be demonstrated.  
1.3.7   India – Air Conditioner and its related Parts (Quality Control) Order, 2018, 
G/TBT/N/IND/74 , G/TBT/N/IND/110  (IMS ID 59833) 
1.173.   The delegation of the United States  provided the following statement. On 28 October 2019, 
India notified its Air Conditioner and its related Parts, Hermetic Compressor and Temperature 
Sensing Control (Quality Control) Order, 2019 (Air Conditioners QCO) to the WTO. U S industry 
submitted comm ents on 22 November 2020 through the United States Enquiry Point to the Indian 
Enquiry Point. We have received no acknowledgement that the comments were received. The 
proposed measure requires exclusive use of Indian standards for air conditioner (A/C) ene rgy 
efficiency; applies separate energy efficiency requirements to component parts; and requires 
certification by the B IS. Can India state whether the Indian standards in the Air Conditioners QCO 
are based on existing international standards? The United St ates notes that the TBT Agreement 
makes clear that more than one relevant international standard can serve as the basis for a technical 
regulation. Many U S companies use relevant international standards developed by the Air-
Conditioning, Heating and Refrig eration Institute  (AHRI) to verify the energy efficiency of their 
products, which are accepted in foreign markets and used extensively by the heating and cooling 
industry. The United States suggests that, to expedite availability of A/C equipment with docu mented 
verification testing records, BIS should also recognize, without further testing, equipment for which 
AHRI's Product Performance Certification Program has verified energy efficiency. The United States 
notes that AHRI standards can provide greater sp ecificity in energy efficiency evaluation than the 
comparable ISO standards for energy efficiency calculations. For example, AHRI standards define a 
specific testing approach related to test set -up and execution. By comparison, the ISO standards 
testing ap proach is less specific, which can cause testing results to vary widely due to variations in 
test set -up.  
1.174.   The United States also notes that applying separate energy efficiency requirements to A/C 
component parts, including temperature sensors and hermetic  compressors, does not accurately 
measure the energy efficiency of A/C systems. Fully -assembled A/Cs are designed to work as 
integrated systems to achieve energy efficiency targets, with the performance of each component 
impacting the performance of the ot her components, as well as the energy efficiency of the overall 
system. Thus, the stand -alone energy efficiency rating is not an accurate indicator of a component's 
energy efficiency when part of the overall A/C system. The United States understands that t he choice 
of components in finished products is already a major consideration for manufacturers when 
designing products to meet energy efficiency requirements. Further, according to U S industry, no 
other markets or relevant international standards apply se parate energy efficiency requirements to 
component parts as a method of energy efficiency evaluation. Finally, the United States reiterates 
its support for a six -month grace period to comply with the requirements for A/C systems, 
particularly given concern s that there may not be enough laboratories to complete the testing in 
India before the deadline. Additionally, if India continues to apply separate requirements to 
component parts, the United States requests that India provide a one -year grace period to c omply 
with the requirements for component parts.  
1.175.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as follow s. This regulation will be enforced after 
1 June 2020; a finished product of air conditioners as well as the related parts will be obligated to 
comply with the BIS standards and place the BIS certification mark. According to the regulation, 
manufacturers operating manufacturing facilities in India should take the BIS certification mark and 
 
33 For previous statements follow the thread under IMS ID  598 (under dates raised and references) . G/TBT/M/81  
 
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  the products must be tested by the designated laboratories in India. However, manufacturers are 
having difficulties in complying with this regulation due to the absence or insufficiency of designated 
testing laboratories. The cur rent status of designated testing laboratories in India as of 25 May 2020, 
for three types of air conditioning finished products, it is confirmed that only one test laboratory has 
been designated for "unitary" and "split" type, and that a test laboratory f or "package" air 
conditioners is still absent. In the case of air conditioning parts, the "temperature sensing control 
devices" can be tested at two designated laboratories, but the laboratory for the "hermetic 
compressor" and "heat exchanger" is not desig nated.  
1.176.   The Korea has raised the issue of compliance with this regulation during regular meetings 
and bilateral meetings through two WTO TBT Committee Meetings (the third WTO TBT Committee 
meeting in 2019, the first WTO TBT Committee meeting in 2020) . The Indian government has 
answered to convey our opinion to the relevant authority at the first regular meeting of the WTO 
TBT Committee in 2020, however Korea has not received any response so far. In this regard, once 
again, Korea would like to request the Indian government as follow s. First, Korea would like to 
request the relevant authority to designate testing laboratory for all area s of finished product and 
related parts and guarantee their capacity for the testing and certification, as well as to  ask to gr ant 
a sufficient grace period after testing laboratories are operational.  
1.177.   Second, if the sufficient number of testing laboratories are not designated or operational 
before the enforcement date, please provide alternative measures such as accepting the 
internationally recognized test reports. In addition, since the regulation stipulates that 
manufacturers should use certified parts in order to take the certification for the finished product, 
more sufficient grace period is required for finished products. Fur thermore, Korean companies have 
recognized that the implementation date has been postponed to January 2021 for related parts and 
July 2021 for finished products, as announced by the competent authority, the D PIIT, through 
attending a public meeting hosted by the Indian C EAMA ; however, there is no official relevant 
information available. Accordingly, Korea would like to ask for India to provide an environment that 
will make it easier for companies to comply with this regulation and to take an official positi on on 
our request above.  
1.178.   In response, the delegation of India provided the following statement. India would like to 
thank the United States and the Republic of Korea for their continued interest in the Air Conditioner 
and its related Parts (Quality Control ) Order, 2018. As regard s availability of laboratories for the 
products mentioned in the QCO, it is informed that recognition of Labs under Laboratory Recognition 
Scheme (LRS 2018) is a continuous and on -going  process. At present, one OSL (Outside Laborato ry) 
has been recognized by BIS under its laboratory recognition scheme (LRS 2018) for testing as per 
IS 1391 (Part 1): 2017 Room Air Conditioners and IS 1391 (Part 2): 2017 Room Air Conditioners: 
Part 2 Split Air Conditioners. Two OSLs have been recognized  for IS 60730 Part: 2 Sec: 9 Year: 11 
– Automatic Electrical Controls for Household and Similar use Pt -2 particulars requirements Section 
9 Temperature sensing controls. The recognition of foreign laboratories will be carried out on a 
reciprocal and mutual ly beneficial basis. Details of the OSLs are available in BIS website. Under the 
provision of BIS (Conformity Assessment) Regulations, 2018, the conformity of the product to 
relevant Indian Standards can also be verified through testing in factory and BIS licence s can also 
be granted on factory -testing basis. Therefore, there is no lack of necessary testing facility, as 
alleged.  
1.179.   DPIIT  has issued Air Conditioner and its related Parts, Hermetic Compressor and 
Temperature Sensing Controls (Quality Control) Order, 2019 under the provisions of BIS Act, 2016 
which envisages Conformity Assessment Scheme -I of Schedule -II of BIS (Conformity Ass essment) 
Regulations, 2018. Inspection at factory premises and testing of product in factory as well as in 
third-party BIS -recognized laboratory are mandatorily requirements of Scheme -I. The testing of 
samples drawn during the factory inspection is carried  out in third -party BIS -recogni zed laboratory. 
However, under the provisions of BIS (Conformity Assessment) Regulations, 2018, the conformity 
of the product to relevant Indian Standards can also be verified through testing in the factory 
provided the manuf acturer has complete in -house testing facility as per relevant Indian Standard. 
IS 1391 (part 1 and 2) are based on ISO 5151 Non -ducted air conditioners and heat pumps — 
Testing and rating for performance. IS 8148 is based on ISO 13253: 2017 Ducted air  conditioners 
and air -to-air heat pumps — Testing and rating for performance and ISO 16358 (Part 1 ): 2013 
Testing and calculating methods for seasonal performance factors of air -cooled air conditioners and 
air-to-air heat pumps — Part 1: Cooling seasonal perf ormance factor. In IS 10617 considerable 
assistance has been taken from IEC 60335 -2- 34: 2012 Household and similar electrical appliances G/TBT/M/81  
 
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  — Safety — Part 2 -34: Particular requirements for motor compressors. IS 11329 for heat exchanger 
is an indigenous stan dard. There are no Energy Efficiency requirements mentioned in the Indian 
standards. The standards deal with the evaluation needed to confirm the specification published by 
the manufacturer for performance and safety. The fact that system standards may not  be able to 
cover evaluation of individual components for performance and safety, countries have published 
performance/safety standards for critical components like compressor s, heat exchangers , etc. for 
the air conditioner.  
1.180.   Members are informed that taki ng into account the request made by certain Members and 
other stakeholders to extend the implementation date of Air Conditioner and its related Parts, 
Hermetic Compressor and Temperature Sensing Controls (Quality Control) Order, 2019, DPIIT in the 
Governme nt of India has extended the implementation date by seven months beyond the schedule 
date of 1  June 2020. Hence the said QCO will come into force with effect from 1  January 2021. This 
has been notified in official gazette dated 18 May 2020 and is available  on the website of DPIIT. For 
any other additional clarity required by the interested Members, India is ready to discuss the issues 
bilaterally.  
1.3.8   Turkey – Draft Amendment of the Regulation on Cosmetics (IMS ID 60334) 
1.181.   The delegation of the United States  provided the following statement. Since May 2019, the 
US Government has engaged with Turkey, via the US Embassy in Ankara, as well as the TBT 
Committee, noting concerns with the Draft Amendment of the Regulation on Cosmetics. U S industry 
is concerned that betwe en 2017 and 2018 the Ministry of Health (MoH) introduced new requirements 
for cosmetics products via changes to the requirements for submission of product registrations in 
the new online filing system. Turkey introduced the filing system at the end of 2017 . These new 
requirements are highly disruptive to trade and put companies' Confidential Business Information 
(CBI) at risk. We understand that Turkey has not published these new requirements as final 
measures, nor did Turkey notify these new requirements t o the WTO. In December 2018, Turkey 
held a domestic public consultation in Turkey on a Draft Amendment to the Cosmetics Regulation, 
which included most of these new requirements, but the Draft Amendment was never published as 
final, nor did Turkey respond to comments submitted by the Personal Care Products Council via the 
domestic consultation. In June 2019, Turkey indicated to the US Government that it would notify 
the Draft Amendment to the WTO, with a 60 -day comment period, but it still has not done so. When 
does Turkey intend to notify the Draft Amendment and the other new requirements? We hear from 
US industry that exporting cosmetics products to Turkey has become even more challenging since 
we first raised these concerns with Turkey. US companies repor t Turkey subjects products to 
additional inspections and other requirements, if the companies do not provide all the information 
requested in the new online filing system. We urge the MoH and Ministry of Trade (MoT) to issue an 
official statement suspendin g implementation of any new, unpublished requirements for cosmetics 
until Turkey notifies the measure to the WTO. Turkey needs to conduct an additional public 
consultation for all of the new requirements since 2017 for at least 60 days following that notif ication, 
and adopt a final rule taking into account comments received during the public consultation. Further, 
we request that the MoH and MoT also meet with US industry and the US Embassy staff in Ankara 
to discuss industry's concerns. Turkey's cosmetics exports to the US are growing, up 66% from 2017 
to USD 42.7 million in 2019. However, since 2017 when these new requirements were first 
introduced, US cosmetic exports to Turkey have dropped by 39% ( change in US exports from 2017 
through 2019).  
1.182.   In response , the delegation of Turkey  provided the following statement. Turkey would like 
to thank the United States for its comments on the draft amendment of the regulation on cosmetics. 
We would like to inform the Committee that we have an on -going  internal coordi nation on the draft 
regulation taking into consideration the raised concerns by our trade partners. As we have stated 
previously, the Cosmetic Regulation of Turkey is one of the areas where harmonization with the EU 
legislation is continuing as a requireme nt of the EU -Turkey Customs Union Agreement. Therefore, 
both the M oT and the Ministry of Health have been evaluating the EU Commission's comments on 
the draft Cosmetic Regulation. In this regard, the Turkish authorities have been working on the 
regulation being in line with EU legislation and do not intend to create unnecessary barriers to trade. 
In addition, Turkey is planning to make an official TBT notification allowing a 60 -day comment period 
to WTO Members after re -drafting the amendment. Turkey would like to reiterate its willingness to 
 
34 For previous statements follow the thread under IMS ID  603 (under dates raised and references) . G/TBT/M/81  
 
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  communicate and work together with the interested Members, as in the past, to address any specific 
concerns they may have on Turkey's Cosmetic Regulation.  
1.3.9   United States – Modernization of the Label ling and Advertising R egulations for 
Wine, Distilled Spirits, and Malt Beverages, G/TBT/N/USA/1429 , 
G/TBT/N/USA/1429/Add.2  (IMS ID 60135) 
1.183.   The delegation of the European Union  provided the following statement. Referring to the 
detailed written comments sent on 26 June 2019 as regards the draft Modernization of the Labelling 
and Advertising Regulations for Wine, Distilled Spirits, and Malt Beverages, the EU would like to 
welcome the Final Rulemaking of the Alcohol and Tobacco Tax and Trade Bureau (TTB) notified as 
an addendum to the original notification on 3 April 2 020, which addresses some of the comments. 
The EU also welcomes the decision of the TTB as regards not to adopt certain proposals pertaining 
to spirits. The EU would like to draw attention to its remaining concerns , notably important questions 
regarding th e labelling of wines, labelling of spirits, use of the term organic and provisions that relate 
to appellations of origins and names of geographic significance that may be covered by Chapter 3 of 
the TRIPS Agreement. The EU would like to ask the US for clar ification as regards the expected 
timeline for these specific concerns, as well as confirmation that the US will notify its Regulation to 
the Council for TRIPS, in accordance with the undertaking in Article 63 of the TRIPS Agreement.  
1.184.   The delegation of Japan provided the following statement. While initially supporting the 
concerns raised by the European Union during Phase 2 of the Written Procedure, Japan subsequently 
said it withdrew from supporting these concerns during Phase 3 of the Written Procedure.  
1.185.   In response, the delegation of the United States  provided the following statement. The 
United States thanks the European Union for its interest in its proposed rulemaking concerning the 
modernization of its alcohol beverage labelling regulations. On 3 April 2020 the United States 
submitted an addendum t o its original notification as G/TBT/N/USA/1429/Add.2 , which announced 
the final rule. TTB has finalized certain liberalizing and clarifying changes that were proposed, and 
that could be implemented quickly and provide industry members greater flexibility. TTB has als o 
identified certain other proposals that will not be adopted, including the proposal to define an "oak 
barrel" for the purposes of aging distilled spirits, the proposal to require that statements of 
composition for distilled spirits specialty products lis t components in "intermediate" products and list 
distilled spirits and wines used in distilled spirits specialty products in order of predominance, and 
the proposal to adopt new policies on the use of cross -commodity terms. TTB continues to consider 
the re maining issues raised by comments it received that are not addressed in this document. TTB 
plans to address those issues in subsequent rulemaking documents. The regulatory amendments in 
this document will not require industry members to make changes to alc ohol beverage labels or 
advertisements and instead will afford them additional flexibility to make certain changes if they 
wish.36 
1.3.10   Ecuador – Energy Efficiency Requirements for Clothes Dryers for Domestic Use , 
G/TBT/N/ECU/439 , G/TBT/N/ECU/439/Rev.1 , G/TBT/N/ECU/439/Rev.1/Add.1  (IMS 
ID 59937) 
1.186.   The dele gation of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as follow. First of all, thank you for agreeing with 
us about requests raised by Korean side in the last WTO TBT Committee me eting and for the decision 
to review the draft. To remind Korea's request in the last WTO TBT Committee, according to the 
Ecuador's energy efficiency requirements for clothes dryers, a range of energy efficiency classes for 
sale of dryers is limited to A a nd B. Including international standards for IEC 61121 that applied by 
your country, countries around Latin America such as Chile and Peru have no restrictions on sales 
as per minimum energy classes. In addition to this, A and B classes, which restrict the sales in your 
country, are too high to meet the standards. Thus, it is estimated that it may be difficult for all 
dryers to enter into the Ecuadorian market. This is because the class for all dryers that are currently 
sold globally are estimated to be Clas s C or lower under this amendment. In this regard, Korea would 
 
35 For previous statements follow the thread under IMS ID  601 (under dates raised and references) . 
36 The full text of the final measure and substantive replies to comments can be found here: 
https://www.govinfo.gov/content/pkg/FR -2020-04-02/pdf/2020 -05939.pdf . 
37 For previous statements follow the thread under IMS ID  599 (under dates raised and references) . G/TBT/M/81  
 
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  like to ask once again Ecuador to withdraw the clause for the minimum allowable classes for sale in 
this regulation and to share the timeline of the amendment process.  
1.187.   In response, the delegati on of Ecuador  provided the following statement. With regard to the  
trade concern raised by the Republic of Korea concerning the revision of Technical Regulation 
RTE INEN 111, which has been in force since 2015, Ecuador wishes to reiterate its comments from  
the previous meeting of this Committee . The draft revision of this Technical Regulation was notified 
to the WTO on 20  May 2019, giving a period of 60 days for Members to submit comments, as 
required by the Agreement on Technical  Barriers to Trade.  The dra ft revision was subsequently 
amended in light of the comments made by interested parties. Furthermore, as a result of the 
meeting requested by the Republic of Korea on 16  December  2019, Ecuador explained the process 
for updating the Regulation and reported  that no comments had been received from Korea during 
the official comment period.  It should be noted that in order to avoid creating unnecessary obstacles 
to trade, Ecuador established a new comment period running until 5  January  2020.  For its part, the 
Republic of Korea sent its comments on 3  January this year. Following the respective review and 
analysis by the competent authority, it was decided that it would be necessary to request additional 
information.  
1.188.   Therefore, on 30  April this year, additional documents were requested from the contact point 
of the  Republic of Korea. We are still waiting for these documents in order to continue our technical 
analysis.  This matter aside, Ecuador wishes to point out that its energy efficiency policy seeks to 
increase the efficient use of energy throughout the supply chain and by end users. The policy is in 
line with the country's international commitments, which include those under the Paris Agreement 
and the 2030  Agenda for Sustainable Develop ment. This responds to the need to provide the country 
with energy security and sufficiency, while reducing greenhouse gas emissions; indeed, energy 
efficiency is considered the most cost -effective way of mitigating climate change and protecting 
non-renewa ble natural resources.  Lastly, Ecuador reiterates it s commitment to addressing in a 
timely manner Members' concerns and comments regarding its various draft technical regulations. 
Proof of this is our flexibility regarding the amount of time given for Memb ers and, in particular, the 
Republic of Korea, to submit their comments.  
1.3.11   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 , 
G/TBT/N/BHR/518 , G/TBT/N/KWT/400 , G/TBT/N/OMN/350 , G/TBT/N/QAT/517 , 
G/TBT/N/S AU/1048 , G/TBT/N/ARE/407 , G/TBT/N/YEM/120  (IMS ID 57 238) 
1.189.   The delegation of the United States  provided the following statement. The United States 
understands that GCC members are reviewing the GSO draft "Technical Regulation for the Restriction 
of the use of certain Hazardous Substances in Electrical and Elec tronic Equipment " and plan to 
approve the final regulation in May 2020 with a one -year transition period. Since receiving the GCC's 
reply to U S comments on the measure in March 2019, the United States and U S industry still have 
concerns that the two levels  of conformity assessment procedures are overly burdensome, as they 
include a self -declaration of conformity and an additional pre -market testing and model inspection 
certification scheme that must be updated annually. This approach would be a significant deviation 
from and significantly more burdensome than common international practice in other markets to 
rely on self -certification for Restriction of Hazardous Substances (RoHS) regulations.  
1.190.   US industry would support the GCC and GSO aligning the conformity  requirements to the 
widely used EN 50581/IEC 63000 standard. Following the associated conformity and risk assessment 
process identified in that standard would significantly reduce the scope, and thus the added burden, 
of the proposed requirement for manda tory annual testing. The GCC clarified in response to U S 
comments that producers are responsible for registering and label ling products with the GCC Mark. 
However, U S industry remains unsure which entity in the supply chain bears responsibility to affix 
the GCC Mark to the product. To definitively resolve such uncertainty, we request that this 
responsibility be clearly stated in the regulation as the producer's obligation. Additionally, U S 
industry requests that the GCC not require product -specific QR codes , which could impede the time 
to market or product availability.  
 
38 For previous statements follow the thread under IMS ID  572 (under dates raised and references) . G/TBT/M/81  
 
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  1.191.   The United States also requests information on how the GCC and GSO plan to harmonize 
the acceptance of the same test results across each GCC member state. U S industry is concerned 
that the United Arab Emirates and Oman are already taking different approaches in preparing to 
implement the regulation of hazardous substances, and that GCC member states may vary in 
accepting or rejecting the identical test results  despite the GCC's stated intention for a harmonized 
technical regulation and conformity assessment procedure. The United States also asks that GCC 
members re -notify this measure to the WTO in the future if there are any substantive updates to 
the regulati on or to the implementing guidelines for the conformity assessment procedures according 
to the TBT Committee Recommendation on Coherent Notification Formats ( G/TBT/35) . 
1.192.   The delegation of the European Union  provided the following statement. The European Union 
would like to express support to th e comments made by the United States. The EU would like to ask 
about the status of the draft GCC Technical Regulations for the Restriction of the use of certain 
Hazardous Substances in electrical and electronic equipment, notified to the TBT Committee in M arch 
2018, and the expected timeframe for its adoption. The European Union commented on the draft 
text, to which the GSO responded in July 2018. However, there are still uncertainties in terms of 
requirements as well as timing of adoption and entry into fo rce. These include: uncertainty about 
the process and timelines to transpose requirements into national legislation. The EU would like to 
know when the measure would be transposed in each individual country, and whether it would 
replace existing regulation  and how the uniform application of the regulation would be guaranteed.  
1.193.   The EU would like a clarification on whether conformity assessment results accepted in one 
GCC member state would also be recognized in other GCC countries. If this were not the case, the 
EU would invite the GCC to ensure the mutual recognition of conformity assessment results in GCC 
countries. The EU would like to ask for a sufficiently long transition period that would ensure a 
smooth implementation and adaptation for economic operato rs. There remains uncertainty regarding 
the requirements for the declaration of conformity. The proposal appears to include a mandatory 
third-party conformity assessment, including pre -market testing model certification. This would 
deviate from common inte rnational practice, followed also by the European Union, that relies on 
self-declaration of conformity. The EU therefore urges GCC members to consider limiting the 
conformity assessment requirements to self -declaration of conformity, in order to avoid the 
administrative burden and costs of approval by third -party assessments. Finally, we are concerned 
by the lack of clarity regarding the scope. Annex 1 seems to provide an exhaustive list but this has 
not been confirmed. The European Union would like the GCC  members to clarify these uncertainties 
as soon as possible. We would also to invite GCC members to notify any potential substantive 
amendments to this measure in the future.  
1.194.   In response, the delegation of the United Arab Emirates , on behalf of the Kingdom  of 
Bahrain, the State of Kuwait, Oman, Qatar, Kingdom of Saudi Arabia and Yemen,  provided the 
following statement. The delegation of the United Arab Emirates, in its capacity as the current 
coordinator of the GCC countries, would like to submit the follow ing response on behalf of the 
Kingdom of Saudi Arabia.  Saudi  Arabia thanks the United States and EU for raising this concern 
regarding the technical regulation to ban hazardous substances in electrical appliances and 
equipment. Since this technical regulat ion is still at the commenting stage, we will discuss these 
comments deeply along with other GCC members. We would also like to strongly advise the US and 
the EU to raise these concerns to GSO, which is the common platform for all GCC countries.  
1.3.12   China – Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods (IMS ID 61139) 
1.195.   The delegation of the United States  provided the following statement. The United States is 
very concerned with China's draft "Administrative Measures for Reg istration of Overseas Producers 
of Imported Foods " (Administrative Measures) and urges China to reconsider putting in place such 
a restrictive and burdensome regulation. The measure appears to affect all food products, including 
both low -risk products and products that are already accompanied by health and safety certificates 
issued by US authorities. Furthermore, the measure requires foreign competent authorities to 
confirm that manufacturers are in continuous compliance with China's laws, regulations, and  
standards. Such requirements may impose additional burdens on foreign competent authorities that 
exceeds the resources and expertise available.  We anticipate that the draft measure, if implemented, 
would likely create major trade disruptions for every cou ntry that exports food and agricultural 
 
39 For previous statements follow the thread under IMS ID  611 (under dates raised and references) . G/TBT/M/81  
 
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  products to China, including for developing countries whose competent authorities may have limited 
capacity to meet China's proposed requirements. During the February TBT Committee meeting, 
China indicated that it wo uld notify the measure to the WTO SPS and TBT Committees, respectively, 
to allow for comprehensive feedback from China's trading partners, but has not done so thus far. 
Does China have a timeline for notifying this measure to the WTO? Further, we request t hat China 
seriously consider the concerns expressed in feedback submitted during the domestic comment 
period.  
1.196.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as foll ows. China's draft "Administrative Measures 
for Registration of Overseas Producers of Imported Foods " (Administrative Measures) announced in 
December 2019 stipulates that all overseas producers of imported foods shall report to the Chinese 
government and r equires those of high -risk products to submit dossiers such as an annual audit 
report. We share China's deep concerns and deliberations regarding the safety of imported foods. 
However, the measure appears to impose an unnecessary burden on exporters to Chi na and 
constitute trade barriers for several reasons, which include the following: (i) the delay in the 
registration process caused by the expansion of registration scope; and (ii) the ambiguity of the 
registration process and the regulation. Furthermore, we believe that the measure should be 
carefully reviewed since it could place an enormous administrative burden on competent authorities 
of exporting countries. Korea delivered its comments on the measure through the Korean Embassy 
in China in December 201 9. In the comments, Korea requested a reply from China, including 
information on the measure's scope of application, registration standards and requirements, detailed 
processes. Hence, we would like to enquire about the assessment results of the measure, s ubsequent 
developments, and the timeline for its notification. We also look forward to China's reply to Korea's 
comments made on 24 December 2019.  
1.197.   The delegation of Switzerland  provided the following statement. Switzerland would like to 
reiterate its conce rns made previously in this Committee and in writing to the competent Chinese 
authorities regarding the proposed registration of overseas manufacturers of imported food. 
Switzerland understands and supports China's objective to ensure that only safe food i s imported. 
However, we regret that China has not taken the opportunity to respond to our questions and 
comments. Hereby, we would like to raise our concerns once more over the potential impact for 
Swiss businesses and their exports to China. First, the Ad ministrative Provision proposes to expand 
the registration of overseas manufacturers to include all food categories irrespective of their risk -
profile. Without further justification or explanation, the measure seems to restrict trade more than 
necessary an d thereby to contradict the TBT Agreement. Second, the measure may create significant 
trade disruptions at a time when the coronavirus  pandemic is already putting supply chains under 
considerable strain and causing significant challenges to businesses arou nd the world. Delays in the 
evaluation procedure of overseas food manufacturers are likely to occur, thereby negatively affecting 
the availability of imported products in China. Third, the measure will put foreign exporters at a 
disadvantage over their Chi nese competitors, since the measure is directed exclusively to overseas 
manufacturers, raising concerns over China's obligation to bestow "no less favourable " treatment to 
like products irrespective of their origin (under Article 2 .1 of the TBT Agreement). We call on China 
to consider other ways and means on how to ensure the importation of safe food products. We stand 
ready to engage with China on this matter and look forward to receiving detailed answers to our 
questions and comments.  
1.198.   The deleg ation of Mexico  provided the following statement. The delegation of Mexico  
hereby  refers to the draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods that were published by the General Administration of Customs of China (GA CC) on 
26 November 2019 (hereinafter "draft measures").  The administrative measures seek to replace 
Decree No. 145 on "a dministrative measures for registration of overseas producers of imported 
foods", issued by China's General Administration of Quality Su pervision, Inspection and Quarantine 
(AQSIQ).  The measures in question establish registration requirements for producers and importers 
of food and food products, including a  recommendation by the competent authority in the country 
of origin, a risk assessm ent of the products to be imported,  and possible onsite visits or inspections 
of exporting enterprises .  
1.199.   Mexico's concerns are based on the following : (i) Definition of scope : The scope of the draft 
measures is unclear . The measures do not establish any ca tegories or include a list of the products 
covered; (ii) Labelling requirements : The draft measures also include labelling requirements for a 
"minimum sales package", but do not specify the scope of the products covered or explain the G/TBT/M/81  
 
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  meaning of "minimum s ales package"; and (iii) Additional procedures for competent authorities in 
countries of origin : The draft measures require the competent authorities in the country of origin to 
follow an additional certification procedure in order to ensure compliance wit h Chinese regulations . 
This would represent an additional procedure for the Mexican authorities and for exporters, who 
would have to certify their products twice . The first procedure would involve ensuring compliance 
with the export requirements contained in domestic regulations, while the second would involve 
ensuring compliance with requirements for exports to China . This procedure would impose 
burdensome workloads on exporters and the Mexican authorities, and may therefore contravene the 
principle of pro portionality provided for in Article 2.2 of the WTO Agreement on Technical Barriers 
to Trade (TBT Agreement ) by constituting an unjustified measure that would affect trade . Risk 
assessment : the draft measures require that a specific risk assessment be carried out for the product 
before importers may be registered , but include no information on the scientific or technical basis 
for the determination of the proposed assessment . China needs to i dentify whether the required risk 
assessment is based on an international standard . Transparency : the draft measures were not 
notified to the members of the WTO TBT Committee. This prevents the effective implementation of 
Article 2.9 of the TBT Agreement, particularly in terms of providing TBT Committee members with 
the opportunity to make comments and participate in the development of the measures concerned . 
1.200.   In light of the foregoing , the delegation of Mexico kindly requests the delegation of China to 
clarify the scope of the draft measures, and the labelling requirements covered by these measures . 
If alcoholic beverages are covered by these regulations, Mexico would be interested in engaging in 
bilateral dialogue with the Chinese authorities to discuss a l ess restrictive procedure for tequila 
imports, and would like to propose the acceptance of a certificate of authenticity . Explain how the 
proposed measures are effective and proportionate in terms of meeting China's legitimate food 
safety objective . Share the technical and scientific information and international standards on which  
these measures are based . More specifically, we would like to know the justification for requesting 
risk assessments for the products covered . Notify the measure to the WTO TBT C ommittee so that 
Members can participate in the public consultation process . Also, provide information on the date 
set for entry into force, subsequent steps , and the implementation process . The delegation of Mexico 
thanks the delegation of China for givin g its consideration to this statement and to the requests 
made therein . 
1.201.   The delegation of the European Union  provided the following statement. The EU is also very 
concerned about this measure as this will have a serious impact on importers into China. The 
delegation of the EU in China commented extensively on the proposals in December 2019. We 
understand that China Customs received many comments similar to ours. As presented, the measure 
would bring substantial additional administrative burden for companies , competent authorities 
including China Customs. The already long and time -consuming registration process will be further 
extended. The EU shares China's concerns as regards to food safety. Nevertheless, measures have 
to avoid unnecessary constraints. They  should be in conformity with WTO Agreements and Codex 
Alimentarius guidelines.40 Accordingly, inspection systems should be applied to particular 
commodities and processing methods in proportion with the associated risks. The measure covers 
all food and bev erages imported into China. This suggests that the rules proposed are applicable 
regardless of the risk associated with the products concerned. It will thus have a serious impact on 
the transaction costs of our trade, and very little impact, if any, on its  safety. In other words, this 
measure appears highly disproportionate for products that are currently traded under a self -
registration regime. The EU kindly requests China to explain the objective of this proposal and stands 
willing to discuss any legitima te concerns in order to find consensual solutions. The first step towards 
such a dialogue would be an official notification by China through WTO channels in order to frame 
our discussions.  
1.202.   The delegation of Japan  provided the following statement. Japan sha res the concerns on 
China's draft administrative measures for registration of overseas producers. Japan has been 
seriously concerned that the China's proposed measures would create unnecessary trade barriers 
and have negative impacts on food trade between China and WTO Members. The measures would 
require foreign competent authorities to inspect and supervise manufacturing companies in 
accordance with Chinese laws and regulations, and confirm their compliance with the Chinese laws 
and regulations, covering a ll food products imported into China. However, China has not provided 
 
40 i.e. CAC/GL 20 -1995 on principles for food import and export inspection and certification . G/TBT/M/81  
 
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  any scientific assessment to rationalize the scope of the measures, in terms of the risks of each food 
product. The measures could be overly trade  restrictive without scientific evidence . 
1.203.   If the measures are implemented, the range of overseas manufacturers required to register 
will be expanded, which will increase the costs, including labo ur and time, and cause negative 
impacts on Chinese consumers due to cost pass -throughs. In addition, since the information 
disclosure standards in China are unclear, China's competent authorities may perform arbitrary 
operations, which may result in a barrier to entry for foreign manufacturers. Japan requests that 
China's proposed measures be suspended. J apan would like to request China to notify the measure 
in question to the WTO TBT and SPS Committee s in a timely manner, provide relevant information 
on this matter as appropriate, and properly address the concerns of the WTO Members.  
1.204.   The delegation of Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to thank China for confirming, at the previous meeting, that a draft of the 
administrative measure will be notified to the Committee when it is ready. We are interested in 
knowing the current status of the draft and the timeline of its legislative work. We look forward to 
the opportunity of commenting on the draft measure again.  
1.205.   In response, the delegation of China  provided the following statement. We would like to 
thank the relevant WTO Members for their attention to China's revision of the "Administrative 
Measures for Registration of Overseas Producers of Imported Foods ". The imp lementation of 
registration of overseas producers of imported food is based on the requirement of the Food Safety 
Law of the People's Republic of China. With China's further opening up, both the trade volume of 
imported food and the number of foreign food production enterprises registered are growing 
significantly, the former registration administrative measures can no longer meet the requirement 
of the current situation. Therefore, China is revising the "Administrative Measures for Registration 
of Overseas  Producers of Imported Foods ", with the aim of effectively implementing the legal 
provisions and improving the management system. The revision follows the principle of classified 
management on the basis of risk analysis, the core of which is to further opt imize the registration 
procedures, clarify the responsibilities of all relevant parties and facilitate the registration and trade. 
At present, the revision of the "Administrative Measures for Registration of Overseas Producers of 
Imported Foods " is still a t the drafting stage. Once the drafting is completed, China will make 
notification to WTO according to the relevant notification procedures and will welcome comments 
and suggestions from all Members.  
1.3.13   France – Mandatory Labelling of SAR Radio Equipment , G/TBT/N/FRA/184 , 
G/TBT/N/FRA/185  (IMS ID 61741) 
1.206.   The dele gation of China  provided the following statement. China thanks France for notifying 
the Draft decree on the displaying of the specific absorption rate of radio terminal equipment and 
Draft order on consumer information regarding radio terminal equipment ( G/TBT/N/FRA/184 , 
G/TBT/N/FRA/185)  on 3 April 2018. Although we fully respect the EU's legitimate objective of 
protecting human health and safety, the measures are more trade  restrictive than necessary in view 
of the risk of non -compliance and therefore in contravention of Article 2.2 of the TBT Agreement. 
China sent our comments to the French TBT Enquiry Point on 28 May 2018 ; unfortunately we have 
not received a reply till today. However, we learn ed that the act would take effect on 1 July 2020. 
Since our concerns have not  been resolved, we have to reiterat e our comments as follows. Firstly, 
we suggest France to cancel the requirement of displaying the values of the specific absorption rate 
(SAR). Under the European Union's Radio Equipment Directive (RED), which has been transposed 
into French law, one of th e mandatory requirements is adherence to the SAR limits. If a RED -
compliant device obtains the CE mark , it means that the product complied with the SAR limits and 
deemed to be safe for people. Therefore additional displaying of the SAR values is unnecessar y and 
will add extra cost to manufacturers. In addition, whether the SAR value tested according to the 
relevant EU standards is "the lower, the better for consumers", is still controversial. The measures 
may mislead the consumers to think the marked value to be the electromagnetic radiation injury 
value to human body.  
1.207.   Secondly, if the requirements cannot be cancelled, it is recommended that relevant specific 
guidance documents be issued as soon as possible and the implementation be postponed for 12 
 
41 For previous statements follow the thread u nder IMS ID  617 (under dates raised and references) . G/TBT/M/81  
 
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  months b ecause the transitional period is too short for the manufacturers to perform relevant 
compliance tests with the proposed requirements. On one hand, the relevant test methods are 
incomplete. The current EU SAR test standards currently do not have limb s SAR test method for 
handheld devices in addition to limbs SAR test method for wearable devices. On the other hand, an 
implementing guidance seems to be necessary. According to the new requirements ，SAR values of 
head, body and limbs must be marked. However, the  acts do not specify whether all products need 
to be marked with all the SAR values, nor do they provide any guidance to manufacturers by quoting 
regulations or standards. Manufacturers' understanding in accordance with the testing practices and 
product ch aracteristics is that not all products need to display all the SAR values, which has caused 
confusion for manufacturers. Lastly, we would like to highlight again that the final version was 
published on 17 November 2019 and will take effect on 1 July 2020. Such a short transitional period 
will bring great difficulties to manufacturers especially when the relevant test method is still 
incomplete.  
1.208.   In response, the delegation of the European Union  provided the following statement. Thank 
you to the delegation of China for its comments on the mandatory labelling for SAR radio equipment 
notified by France to this Committee on 3 April 2018 under the reference s G/TBT/N/FRA/184  and 
G/TBT/N/FRA/185 . Although Directive 2014/53/EU on the harmoni zation of the laws of the m ember 
States relating to the making available on the market of radio equipment does not impose 
compliance with specific technical specifications, Article 17 thereof provides that "the manufacturer 
shall perform a conformity assessment of the radio equipmen t with a view to meeting the essential 
requirements set out in Article 3 ", in order to be able to place it on the market. These essential 
requirements include the SAR limit values given in the harmoni zed standards, resulting from the 
Council recommendation  of 12 July 1999 on the limitation of exposure of the general public to 
electromagnetic fields, which recommends that the member States should aim to achieve compliance 
with the basic restrictions featured in Annex II. For the 100 kilohertz to 10 gigahertz  frequency band, 
these basic restrictions are expressed as SAR values.  
1.209.   In France, the values set out in the recommendation were included in Decree No 2002 -775 
of 3 May 2002 on the limit values for exposure of the general public to electromagnetic fields em itted 
by equipment used in telecommunication networks or by radio installations and in the Order of 
8 October 2003 establishing the technical specifications applicable to radio terminal equipment. The 
notified draft decree and order are therefore not liabl e to create any legal ambiguity or insecurity. 
The objective of the decree is to inform the consumer of the value of the SAR, the measurement of 
which is provided for by the aforementioned texts. In addition, Decree No 2010 -1207 of 12 October 
2010 on displ aying the SAR of radio terminal equipment and the Order of 12 October 2010 on 
displaying the specific absorption rate of radio terminal equipment have been in force since 2011. 
The application of these regulations has not prompted any response from telepho ne manufacturers 
and importers, who have not reported any obstacles to placing the equipment in question on the 
market.  
1.210.   In France, consumer associations and individuals regularly ask the national authorities about 
public exposure to radio frequencies parti cularly because radio equipment is becoming increasingly 
numerous and because authorities need to respond to public concerns related to future 5G networks. 
In its opinion s, the French Agency for Food, Environmental and Occupational Health and Safety 
(Anses ) has recommended improving public information and making it compulsory to display the 
SAR: expert appraisal "Radio frequencies and Health ", 201342 and expert appraisal "Exposure to 
radio frequencies and child health ", 2016.43 In addition, with regard to the  remark on the need for 
a guidance to manufacturers, France would like to point out that, as of 18 March 2020, the French 
National Agency of Frequencies issued guidelines on the SAR in both English and French.44 Finally, 
on the point of the requested transi tional period, France would like to recall that the entry into force 
of both the order and draft decree are set for 1 July 2020.  
 
42 https://www.anses.fr/fr/system/files/AP2011sa0150Ra.pdf . 
43 https://www.anses.fr/fr/system/files/AP2012SA0091Ra.pdf . 
44 The guidelines can be found at: https://www.anfr.fr/controle -des-frequences/exposition -du-public -
aux-ondes/le -das/le -controle -du-das/. 
 G/TBT/M/81  
 
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  1.3.14   Russian Federation – Law No. 425 – on Amending Article 4 of Russian Federation 
Law "On Protecting Consumer Rights" (IMS ID 61245) 
1.211.   The delegation of the United States  provided the following statement. We are again raising 
our concerns about the recently adopted amendment to Russia's "Law on Protection of Consumer 
Rights, " which requires pre -installation of Russian software on "technically complex goods " (TCGs ) 
sold in Russia. Since the last TBT Committee meeting, Russia has issued a draft regulation providing 
some additional information on implementation of the law, including the types of consumer 
electronics covered by the term "technically complex goods " and certain categories of software that 
must be pre -installed. We also recognize that Russia has postponed the implementation deadline 
until 1 January 2021, due in large part to the coronavirus pandemic. Nevertheless, many concerns 
and questions remain. We pr esented some of these questions to Russia in writing in March, but have 
not yet received a response. When we raised this issue in the February meeting, Russia asserted 
that the measure is not a technical regulation. However, the TBT Agreement provides that  a technical 
regulation is any document "which lays down product characteristics and production methods, 
including the applicable administrative provisions, with which compliance is mandatory. " The 
measure mandates product characteristics and production me thods for TCGs sold in Russia,  namely 
that these devices must contain certain software which must be pre -installed. Law No. 425 -FZ 
therefore certainly appears to meet the definition of a technical regulation. If Russia does not agree, 
please explain why th e requirement is not a technical regulation.  
1.212.   In addition, it remains unclear what legitimate objective Russia is trying to achieve with 
these requirements. An Explanatory Note issued by Russia's Federal Antimonopoly Service (FAS) 
stated the need to ensure  non-discriminatory access of Russian software developers to electronic 
devices. Many of the technically complex goods targeted by this technical regulation already feature 
software from Russian developers and include app platforms which encourage particip ation by 
Russian companies. Does Russia have evidence that Russian developers are being denied access to 
develop software for technically complex goods? We ask Russia to explain how the requirement is 
not more trade restrictive than necessary and does not create unnecessary obstacles to trade. We 
also ask Russia to explain how this measure does not discriminate against foreign software products. 
As we have stated before, we urge Russia to notify these implementing regulations to the TBT 
Committee, to allow reasonable time for stakeholders to make comments in writing, to discuss these 
comments upon request, and to take these written comments and the results of the discussions into 
account before finalization and implementation. Finally, we request that Russia  provide a reasonable 
period of at least six months between publication of the final regulation and its entry into force. Even 
the extension of the implementation deadline until 1 January 2021 may not give industry a 
reasonable interval to adapt to the new  requirements.  
1.213.   The delegation of Japan  provided the following statement. Japan would like to share concerns 
regarding this measure expressed by the US. This proposed measure includes unclear articles 
regarding definitions of terms, concrete requirements fo r review and evaluation, and the scope of 
regulations including covered software list. Japan's concern is that the measures may hamper 
market access for foreign companies in Russia, depending on the concrete details of rules governing 
its implementation. T herefore, Japan would like to ask Russia to implement this measure in a non -
discriminatory manner and not to make it more trade  restrictive than necessary in line with the TBT 
Agreement. Japan would like to request that Russia notify this measure and the r elevant regulations 
to the TBT Committee to ensure transparency of the procedure.  
1.214.   The delegation of the European Union  provided the following statement. The European Union 
has concerns on amending article 4 of the Russian Federation Law "On Protecting Cons umer Rights ". 
These concern mainly certain discriminatory aspects as well as the proportionality of the measure. 
On 1 April 2020 the law was postponed from 1 July 2020 to 1 January 2021. We call on Russia to 
comply with its WTO obligations and notify the m easure to the TBT Committee.  
1.215.   In response, the delegation of the Russian Federation  provided the following statement. 
Thank you for the continued interest in the policy conducted by the Russian Federation. The Russian 
Federation reiterates its statement mad e at the previous meeting of the TBT Committee.  
 
45 For previous statements follow the thread under IMS ID 612 (under dates raised and references) . G/TBT/M/81  
 
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  1.3.15   United States – Act to amend the environmental conservation law, in relation to 
regulation of toxic chemicals in children's products (State of New York – Senate Bill 
501B/Assembly Bill 6296A) , G/TBT/N/USA/1581  (IMS ID 61046) 
1.216.   The dele gation of the European Union  provided the following statement. The European Union 
would like to acknowledge the bilateral dialogue held until now with the US, leading to the notification 
in accordance with the TBT Agreement of the State of New York Act to amend the environmental 
conservation law, in relation to regulation of toxic chemicals in children's products. On a general 
note, the EU welcomes initiatives that increase the knowledge about hazardous chemicals in products 
targeted to consumers, and in pa rticular to vulnerable groups like children. However, the EU is 
concerned because the Act introduces a further layer of regulation in addition to the regulations on 
toys that are already in force at Federal and different States' levels. This proliferation of rules and 
requirements on toys leads to a regulatory fragmentation that renders more burdensome and 
complex the sales and imports of toys in the United States.  
1.217.   The EU submitted written comments to the US on 31 March 2020 and have referenced these 
comme nts below. Specifically, the European Union notes that the procedures foreseen for the listing 
of chemicals by the Act are not fully in line with good regulatory practices. The measure does not 
provide for the ability of stakeholders to participate and be heard in the procedure leading to the 
listing of chemicals of concern. Could the United States confirm how will stakeholders and industry 
views be effectively taken into account during this process? Another concern is that the criteria that 
the newly -created children's product safety council will use to recommend to the department the 
listing of high -priority and prohibited chemicals are not defined. Moreover, the Act does not clearly 
establish whether the department will be able to deviate from the recomme ndations made by the 
council and, if so, on which basis and under which criteria. Similarly, the Act does not provide for 
transitional periods for the industry to adapt when new chemicals are to be listed or when such 
listings are reviewed and updated annu ally. Will that happen in practice?  
1.218.   Other than the above procedural issues, the Act also raises a number of concerns on 
substance. The Act provides for a prohibition of chemicals, which excludes chemicals present as a 
trace contaminant. The Act defines "trace contaminant " as a trace amount of a chemical that is 
incidental to manufacturing. However, there is no guidance as to how this "incidental " feature will 
be quantified and measured, which entails a lack of legal certainty for manufacturers as to whether  
the presence of a trace contaminant is allowed or not. Manufacturers have to report to the 
department the use of listed chemicals of concern and high -priority chemicals at the practical 
quantification limits (PQLs). However, there are no indications or gu idance on how high the PQLs for 
the listed chemicals are. They could therefore vary and differ depending on the testing method or 
testing facility used, making them a moving target. The European Union considers therefore that 
these aspects should be fully clarified in the Act or at least that the children's product safety council 
should provide guidance on the notions of trace contaminants and PQLs in order to ensure clarity 
and predictability in the implementation of the measure. Finally, the EU expects th at any future 
proposal for the listing of chemicals of concern, high -priority chemicals or prohibited chemicals by 
the State of New York will be duly notified in accordance with the TBT Agreement, so as to allow 
WTO Members to comment on the proposed listi ng within a 60 -day comment period.  
1.219.   In response, the delegation of the United States  provided the following statement. Thank 
you for your continued interest in this state measure. We have been working with New York State 
and have notified this  as G/TBT/N/USA/1581 . Thank you for your 31 March 2020  comments . The bill 
at issue, entitled "An Act to amend the environmental conservation law, in relation to regulation of 
toxic chemicals in children's products, " was signed by the New York State Governor on 7 February. 
Prior to signing the bill, the Governor's office reached agreement with the New York state legislature 
to make changes to the bill and the bill was signed conditioned upon passage of a new bill that 
incorporates those agreed upon changes. It is our understandin g that based on the agreement 
between the Governor and the Legislature, that the bill will be substantially changed, due in part to 
the concerns raised by stakeholders.  
 
46 For previous statements follow the thread under IMS ID  610 (under dates raised and references) . 
 G/TBT/M/81  
 
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  1.3.16   Colombia – Food Prioritized for its Sodium Content, Certification Requirements , 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1  (IMS ID 60947) 
1.220.   The delegation of the United States  provided the following statement. The United States 
appreciates the opportunity to share our concerns with Colombia's new sodium level requirements 
for various agriculture products notified to the TBT Committee as G/TBT/N/COL/238  and reques ts 
an update on the status of this proposed regulation. The United States supports Colombia's efforts 
to reduce hypertension and related non -communicable diseases. As you may be aware, the United 
States has a similar goal of reducing overall dietary sodium  intake. A key concern is that the 
proposed regulation may not fully consider the technical and the functional role of sodium and 
relevant international commodity standards. U S stakeholders have indicated that they may not be 
able to feasibly reformulate p roducts while still maintaining shelf -life stability, product safety and 
palatability for consumers in the timeline proposed in G/TBT/N/COL/238 . Therefore, the United 
States requests detailed information on the sanctions Colombia plans to place on products that 
exceed the sodium co ntent level. We would also note that Colombia could begin with less restrictive 
targets as a first phase of sodium reduction for its population. This could result in significant public 
health gains while industry has time to develop the needed technologies  to enable further reductions 
and consumer taste preferences adapt.  
1.221.   Another key concern for the United States is the addition of the Certificate of Conformity for 
nutritional declarations. The United States requests details on the frequency these certific ates will 
need to be issued and information on the inspection and confirmation process of these certificates. 
Last, the United States would like to learn how this process will be replicated for domestic products 
in Colombia. We reiterate our interest in ha ving an open dialogue with your Ministry of Health, where 
we can learn and share information regarding ways to develop evidence -based programs to address 
Colombia's public health objectives while minimizing negative economic impact.  
1.222.   The delegation of Ecuad or provided the following statement. Ecuador is grateful for its  
bilateral discussions with Colombia on the draft regulations establishing a maximum sodium limit in 
prioritized processed foods, and welcomes the replies of the Colombian Ministry of Health t o its 
comments.  However, there are still several points of disagreement that lead us to associate 
ourselves with this concern.  The Colombian authority states that the "ban on the sale" of products 
is not really a ban, but that if a product fails to comply with the established parameters, the 
responsible company will be penalized. If we analyse this measure adopted by Colombia, it is clear 
that it will lead to a sales ban, as industries will not want to market products that will result in a 
penalty every tim e the established parameters for sodium are not met. There is no ban on marketing, 
but there will be a penalty: this criterion is considered an obstacle to trade, as it is contradictory.  
1.223.   The Colombian health authority also mentions that a study was conduct ed using statistical 
methods and theories and disseminated throughout the sector.  Thanks to information obtained from 
Colombian manufacturers that export to our country, Ecuador is aware that when this policy to 
reduce sodium was first drawn up, it was sup posed to be voluntary; then the Colombian Ministry of 
Health requested that it become a mandatory regulation and it was submitted for public consultation 
for the first time in 2017. In 2019, the draft was once again submitted for public consultation with 
minor changes and a regulatory impact analysis, but there is no evidence to suggest that it was 
widely disseminated among the manufacturing sector or foreign industry stakeholders.  Colombia 
must disseminate and share this type of draft, with the appropriate technical backing, not only with 
stakeholders from the Colombian industry, but also with the foreign industry that markets products 
in Colombia. In addition, the policy established by Colombia should be backed by technical references 
to other s tandards, such as those in the Codex Alimentarius, in order to establish values that do not 
create barriers to trade while protecting people's health.  Lastly, Colombia has indicated that the 
sodium limit established only refers to added sodium and not to t he total amount of sodium in the 
product. Ecuador requests that this be clarified throughout the document, as the distinction is not 
made in the Colombian draft.  
1.224.   The delegation of Costa Ri ca supported  concern s on this measure.  
1.225.   The delegation of Guatemala  provided the following statement. Guatemala wishes to thank  
the United States for including this item on the agenda. We recognize the legitimate objective of the 
Colombian authorities to ensure human health and, in accordance with the technical regulations 
 
47 For previous statements follow the threa d under IMS ID  609 (under dates raised and references) . G/TBT/M/81  
 
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  notified, to establish a maximum sodium content for certain processed foods.  However, we share 
this concern for the following reasons . Firstly,  with regard to conformity assessment, the submission 
of first party declarations of conformity will no longer be  possible as from the date of publication of 
the accreditation of the first body certifying the analytical method, under Article 8.2 of the notified 
draft regulations. Article 8.1 provides that for imported products, the certificate of conformity must 
be attached to the import licence or registration. We consider this to be a rather restrictive measure 
on international trade.  Secondly,  as to the February meeting, Colombia has clarified that the sale of 
food exceeding the maximum content for year 1 and year 3 will not be prohibited. Article 11 provides 
that penalties will be established following the procedure set forth under the law. Such penalties will 
result in the inability to sell food, as they will prevent the company from continuing to operate 
normally . Guatemala thus reiterates its concern at this measure.  Thirdly,  for small economies such 
as Guatemala's, the lack of harmony among provisions of standards and regulations at the 
international level, compounded by the lack of measures to facilitate intern ational trade, hinders the 
ability of small and medium producers to enter the international market.  
1.226.   The delegation of the European Union  provided the following statement. The European Union 
would like to thank Colombia for its reply of March 2020 to the EU  written comments of November 
2020 and would appreciate any updated information on the status of the draft regulation. The 
objective pursued by Colombia to reduce overall sodium intake in an attempt to contribute to the 
reduction of high blood pressure and  other associated diseases is one the EU fully supports and 
shares. The European Union would like to ask Colombia for some clarifications with regard to the 
Certificate of Conformity for nutritional declarations and more specifically on the period of valid ity 
and the verification process for said certificate. The EU also notes that the certificate can only be 
issued by certain bodies and that sodium content can only be determined by laboratory analysis. 
The European Union would like to ask Colombia under wh ich conditions certificates issued by foreign 
laboratories would be recogni zed. Furthermore, the EU would welcome clarifications as to the type 
of sanctions that would be imposed following the date of entry into force of the regulation to products 
that wou ld not comply with the technical specifications stipulated therein.  
1.227.   In response, the delegation of Colombia  provided the following statement. We would like to 
thank the United States for its comments, as well as several Members for their active participati on 
and interest in this regulatory process.  The Colombian Ministry of Health and Social Protection has 
submitted the latest draft of the draft regulations, which takes into account the comments and 
concerns expressed during the international public consult ation.  These draft regulations are the 
result of a public health measure and are part of a comprehensive strategy called the National 
Strategy for the Reduction of Sodium/Salt Consumption 2012 –2021, which covers not only sodium 
content in processed foods, but also other sources of sodium, such as the salt added to preparations 
in restaurants, at home and in institutions.  The strategy seeks to reduce mortality attributable to 
high blood pressure and cardiovascular disease by gradually reducing salt consumpti on from food 
sources until the WHO recommendation for 2021 has been achieved: 5 grams of salt or 2 grams of 
sodium per person per day.  
1.228.   With regard to concerns about the technical and functional role of sodium in the production 
of prioritized foods, Colombi a wishes to reiterate that this was analysed at all of the technical 
meetings for the 12 categories of food, involving industry, academic and government 
representatives, leading to an agreement and dissemination of the draft regulations. Moreover, the 
penalties envisaged in the draft regulations are those contained in Article 577 of Law No.  9 of 1979.  
As to the deadlines and levels prescribed in the draft regulations, these are based on the 
recommendations of the World Health Organization (WHO) regarding th e establishment of gradual 
targets. The draft regulations established two targets, each spaced by two years, for a total period 
of five years, which should give the industry enough time to develop technologies needed to reduce 
sodium content and consumers'  tastes to adapt.  However, with regard to the concern about the 
addition of the certificate of conformity for nutrition claims, it should be noted that the certificate of 
conformity is not about nutrition claims, but about compliance with technical regulat ions. It should 
also be noted that this document is the same for domestic and international companies. As to time -
frames for issuance, inspection and confirmation, these are established by the certification body and 
are not laid down in the technical regul ations.  
1.229.   Foods were prioritized using a set methodology based on:  eating habits;  the frequency of 
consumption increases the level of salt intake, according to data obtained from domestic food and 
nutrition surveys, such as ENSIN  2010;  sodium content, based on information provided by 
companies on nutrition labels;  high-consumption foods among vulnerable groups of the population, G/TBT/M/81  
 
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  especially children;  foods that are consumed frequently, even when their sodium content per serving 
is not very high (such as bread); and  foods that are marketed as ingredients in premixed products 
used by the baking industry to make bread, baked goods and soup bases for restaurants.  As part of 
the technical meetings, producers sent information on the addictive elements, ingredie nts and 
formulation associated with the technological conditions that make it difficult to meet the target and 
the production stage that is critical for this addiction. Therefore, Colombia requests that they indicate 
which foods, which could undermine the meeting of targets, should be analysed and the technological 
grounds for each, so that the technical team can analyse the difficulties.  Similarly, during the 
preparation of these draft regulations, a regulatory impact analysis was conducted, taking into 
consideration the commercial and economic effects of the regulations, the costs for the industry and 
the costs for government. This analysis involved a wage range of stakeholders and showed that the 
benefits in terms of public health outweigh the associated costs of implementation.  
1.3.17   China – Draft revised Encryption Law of the People's Republic of China by the 
Office of State Commercial Cryptography Administration (OSCCA) ( IMS ID 53448) 
1.230.   The delegation of the European Union  provided the following statement. The E U would like 
to reiterate its concern on the Cryptography Law published by the O SCCA . We understand that the 
new Cryptography Law has entered into force from the beginning of this year. The EU remains 
concerned about the wide scope of the law, in conjuncti on with the lack of clarity of a number of 
foundational concepts as well as administrative procedures described in the text. Both of these 
factors will negatively impact business confidence. The EU notes with concern that the new law does 
not recogni ze China's previous commitment made in 2000 that the cryptography -related regulation 
would only apply to products whose core function is that of providing encryption – the so -called 
"Year 2000 Clarification" by the SCA.  
1.231.   The EU calls on China to ensure that legal  and regulatory requirements are based on a non -
discriminatory basis, do not favour specific technologies, do not limit market access and do not lead 
to a forced transfer of intellectual property. Regulatory procedures related to products containing 
crypto graphic components should be transparent, predictable and consistent with international 
practices. The EU urges China to guarantee the possibility for foreign invested enterprises  (FIEs) to 
participate on an equal footing with domestic companies in the pro duction, research, development 
and sale of cryptography products on its market. In this context, the EU would like to draw attention 
to the World Semiconductor Council (WSC) "Encryption Principles" and the exchanges between the 
EU and China in the related "Government/Authorities Meeting on Semiconductors" (GAMS). The EU 
also invites China to notify the draft Cryptography Law to the TBT Committee, as set out in Article  2.9 
of the WTO's TBT Agreement. We would be interested in learning whether China plans to issue any 
implementing regulations to support this law and if so, what is the timetable for these.  
1.232.   The delegation of the United States  provided the following statement. The United States 
would like to support the concerns of the EU and Japan. We outline ou r concerns for this measure 
in our intervention on China's Cybersecurity Law (STC  ID 526). 
1.233.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding the China's "Encryption Law " that entered into force on 1 January 2020 and would like to 
refer to the previous statement we made at the last TBT Committee in February 2020. Japan  would 
like to request that China consider comments from Japan and other Member countries when drafting 
related regulations and that China's regulation not hamper foreign companies' activities or market 
access to China.  
1.234.   The delegation of Canada  provided th e following statement. Canada would like to refer to its 
statement made at the November 2019 TBT Committee meeting, as recorded in paragraph 2.90 of 
document G/TBT/M/79 . Canada continues to kindly ask China to confirm whether the implementing 
regulations will be notified to the TBT Committee  and improve upon the law by ensuring: adherence 
to TBT obligations, including those related to legitimate objectives, transparency and the use of 
international standards; and the scope of application is limited to goods involved in cryptology.  
1.235.   In response , the delegation of China  provided the following statement. The Law on 
Cryptography of China took effect on 1 January 2020. The Law clearly stipulates that the 
governments at all levels and relevant departments shall follow the principle of non -discriminat ion, 
 
48 For previous statements follow the thread under IMS ID  534 (under dates raised and references) . G/TBT/M/81  
 
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  and treat all the organizations equally including foreign -invested enterprises that engage in 
commercial cryptography research, production, sales, service, importation and exportation , etc. The 
State encourages commercial cryptography technical cooper ation based on voluntary principle and 
commercial rules in the process of foreign investment. Administrative agencies and their staff are 
prohibited to force any transfer of commercial cryptography technology by means of administrative 
measures.  
1.3.18   Viet Nam – Decree 116/2017/ND -CP on business requirements for manufacturing, 
assembly and imports of automobiles, automobiles warranty and maintenance services , 
G/TBT/N/VNM/116 , G/TBT/N/VNM/116/ Add.1 , G/TBT/N /VNM/116/Add.2 , 
G/TBT/N/VN M/140  (IMS ID 54949) 
1.236.   The delegation of the European Union  provided the following statement. Due to recent 
developments concerning Decree 116, the EU does not consider this as a specific trade concern any 
longer. The EU would like to express its appreciation  for the efforts of the authorities of Viet Nam to 
solve this issue. The EU will continue to follow this matter closely.  
1.237.   The delegation of Thailand  provided the following statement. Thailand would like to reiterate 
concerns raised in the previous TBT Commi ttee meeting regarding the Decree 116 including its 
revision as Decree 17. Despite the fact that Viet Nam has implemented the Decree 17 in order to 
ease the restrictive procedures for imported cars, some of its conformity assessment requirements 
still leav e negative impact on foreign importers. For instance, Viet Nam should accept UNR or other 
internationally accepted COP as alternatives to certificate based on Vietnamese requirements and 
inspection which impose additional costs to exporting countries. At t he last meeting, Viet Nam 
explained that it was in the process of notifying the Decree 17 to the TBT Committee. Nevertheless, 
Thailand is still concerned that, up to now, Viet Nam has not yet notified the Decree 17 as well as 
its implementing circulars whi ch did not compl y with the transparency provisions established under 
the TBT Agreement. In light of concerns raised, Thailand wishes to remind Viet Nam of its obligations 
under Article 5.6 of the TBT Agreement to notify other Members of its proposed confor mity 
assessment procedures at an early appropriate stage when comments can be taken,  and 
amendments can be made. Furthermore, particularly under Article 5.9, Viet Nam shall allow a 
reasonable grace period for exporting Members to adapt their products or me thods of production to 
introduced requirements. Thailand, moreover, would like to respectfully ask Viet Nam to share any 
updated information on the raised concerns.  
1.238.   The delegation of Japan  provided the following statement. Japan would like to share concern s 
regarding Decree 116 expressed by Thailand and the EU. We welcome the amendment of the Degree 
116/2018 (the Degree 17/ 2020) and Circular 3/2018. Japan would like to request that Viet  Nam 
ensure that operation of these revised regulations will not be mor e trade  restrictive than necessary.  
1.239.   In response, the delegation of Viet Nam  provided the following statement. Since the 
implementation of Decree 116/2018/NĐ -CP and Circular 03/2018/TT -BGTVT, Viet Nam Government 
had received many comments from foreign insti tutions and seriously took them into consideration 
for making appropriate adjustments. Accordingly, we have shortly amended and promulgated 
Decree 17/2020/NĐ -CP and Circular 05/2020/TT -BGTVT in order to remove difficulties for importers. 
The Decree 17/2020 /NĐ-CP was notified to WTO Members on 28 April 2020 in notification 
G/TBT/N/VNM/Add.2 , which clearly indicates that the amended and supplemented provisions of 
Decree 116/2018/NĐ -CP shall enter into force from 5 February 2020. For detailed guidance and 
implementation of provisio ns on technical safety and environmental inspection for imported and 
domestically assembled and manufactured automobiles, WTO Members are advised to refer to 
Circular 05/2020/TT -BGTVT of 26 February 2020. Currently, UNECE certificates are recognized under 
Decree 116/2017/NĐ -CP and Circular 25/2019/TT -BGTVT. The specific guidance for recognition of 
imported car parts with these certificates are provided in Item đ  Clause 2 Article 6 of Circular 
25/2019/TT -BGTVT. In near future where EVFTA is officially implem ented, car parts manufactured 
in EU countries and imported with UNECE certificates shall be considered for recognition without 
testing under the provisions as signed by EU and Viet Nam.  
 
49 For previous statements follow the thread under IMS ID  549 (unde r dates raised and references) . G/TBT/M/81  
 
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  1.3.19   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 introduction of the 
mandatory labelling ( IMS ID 56750) 
1.240.   The delegation of the European Union  provided the following statement. On 28 April 2018 
the Russian Government adopted decision № 792 -R, listing goods which will be subject to mandatory 
marking, along with the dates of introduction of these labelling requirements for each product 
category. I t will cover tobacco, perfumes, tyres, different categories of clothing, footwear, cameras, 
dairy, and pharmaceutical products. The EU has very serious concerns on the proportionality of the 
measure: individual labelling and registration creates significan t burden and cost, well beyond the 
cost of the individual labels. This may be justified for some products of high value and with a high 
record of counterfeit or tax evasion, such as tobacco products or furs. However, it seems more trade  
restrictive than ne cessary in the case of lower value products without such a negative record, such 
as towels, bed linen or tyres. Therefore , the EU requests that Russia reviews the scope of products 
covered by the measure so that this focuses on high -value products for whic h there is evidence of a 
high level of counterfeit and/or tax avoidance.  
1.241.   Though we commend the Russian government in its efforts to tackle counterfeiting, this 
measure includes technical regulations and will have a significant impact on imports from the EU  
and from other WTO Members to Russia. According to the Decision of 1995 of the TBT Committee, 
"Members are obliged to notify all mandatory labelling requirements that are not based substantially 
on a relevant international standard and that may have a sig nificant effect on the trade of other 
Members ". Therefore, this measure should have been notified under the TBT Agreement before its 
adoption to give the opportunity to other WTO Members to provide their comments and allow 
sufficient time for industry to a dapt. The European Union would therefore like to urge the Russian 
Federation to notify this measure in accordance with the TBT Agreement. Furthermore the European 
Union would like to request the Russian Federation authorities to prepare a comprehensive gui deline 
providing exhaustive information on technical details such as: timetable of goods to be labelled until 
2024, deadlines, references to legislation, information contact points, Q&A part where the most 
frequent issues would be explained, etc. Such a gu ideline would significantly facilitate situation for 
majority of economic operators, both European and Russian.  
1.242.   The Russian government adopted Resolution No 515 on 26 April 2019 on the "marking of 
goods subject to mandatory labelling by means of identifica tion". Of course, this measure also falls 
within the scope of the TBT Agreement and needs to be notified to the WTO, to open the period for 
comments. In accordance with the TBT Agreement, sufficient time shall be provided to industry to 
adapt to the requir ements necessary for placing products on the market of the Russian Federation, 
which is in general 6 months. Taking into account that such requirements are still being developed, 
the European Union requests an adaptation of the deadlines for implementation , especially for 
products supposed to be labelled very soon. Some deadlines have been postponed, but an unclear 
situation remains on the ground. Current deadlines seem to be the following: Footwear – 1 July 
2020; Medicines - 1 July 2020; perfumes and eau de  toilette – 1 October 2020 ; photo cameras – 
1 October  2020; tyres – 1 November 2020; textiles – 1 January 2021; dairy - 20 January 2021 and 
1 October 2021. These postponements for different categories seem to be largely linked to the 
system not yet being op erational. Operators need additional time to ensure that all products to be 
placed on the market of the Russian Federation can comply. It can take long for a product to reach 
its final consumer, meaning that companies have to introduce necessary changes al ong their chain 
of production months before the date of implementation, which is a particu lar concern for current 
stocks. In addition, introducing these changes in the production cycle ahead of the implementation 
date is difficult, as crucial information o n the exact requirements is still lacking. Moreover, the 
manufacturers have recently been considerably affected by the outbreak of the COVID -19 and all 
corresponding consequences, such as lockdowns, availability of employees, transport disruptions, 
etc. Th erefore, especially for footwear and medicines, label ling of which is supposed to start on 
1 July, further postponement would enable manufacturers to prepare properly for the exercise. We 
ask the Russian Federation to take into consideration the European U nion's comments, to ensure 
that the implementation of this measure is not unecessarily trade  restrictive, in accordance with the 
WTO TBT Agreement.  
 
50 For previous statements follow the thread under IMS ID  567 (under dates raised and references) . G/TBT/M/81  
 
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  1.243.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some comm ents regarding this regulation as follow. This regulation stipulates to attach 
traceable special labels to the products in order to prevent the manufacture of counterfeit goods and 
to protect consumers in Russia. However, the compulsory labelling scheme is  subject to WTO TBT 
notification, but Russian Federation did not comply with the obligation of the WTO TBT notification. 
In this regard, the Korea has requested the WTO TBT notification procedure through the 1st WTO 
TBT Committee meeting 2020, and implemen tation date of footware item has been postponed to 
September 2020. Korea is grateful for the measures Russia has taken, however, with regard to this 
regulation Korea would like to request Russia to take measures to make sure of the compliance with 
the noti fication procedure in accordance with Article 2.9 of the WTO TBT Agreement, so that 
comments can be fully collected from the WTO Member states including Korea.  
1.244.   In response, the delegation of the Russian Federation  provided the following statement. The 
Russian Federation reiterates its statements made during the previous meetings of the TBT 
Committee and sticks to the position that the measure at issue cannot be considered as a technical 
regulation due to the fact that the system does not meet the requiremen ts stipulated in the TBT 
Agreement for technical regulations. The label ling requirements in technical regulations refer to 
fulfilling the technical requirements indicated in technical regulations, i.e. if the product does not 
comply with the requirements o n any indication the relevant label will not be put on it and its 
supplying will not be allowed. We emphasize that the track and trace  (T&T) system is not aimed at 
fulfilling  the requirements stipulated in the relevant technical regulations. Besides, the l abelling 
requirements under the technical regulations should contain the information about the product 
characteristics in a form of inscriptions or the uniform labels as "EAC" or "CE". T&T does not apply 
to the product characteristics or their related processes and production methods. The legislation and 
comprehensive guidelines regulating the T&T, whether effective or drafts, are publicly available in 
the information system of "Chest niy Znak" as well as the information about planned pilots and the 
volume of issued data -matrix code in respect of each type of products covered by the regulation. 
The system is transparent and information on it is available for all stakeholders in the Russian an d 
English languages.  
1.245.   Moreover, we do not consider the system as disproportionate or burdensome as the concept 
in respect of each type of products has been elaborat ed in collaboration with the companies involved 
in manufacturing, supplying and importing the  products covered. In this regard, the mechanism of 
the system should be approved by the business before entry into force. In addition, the price of one 
data-matrix code is approximately half of a ruble which  is less than one US cent. For this reason, 
the measure will not cause additional costs. In addition, according to the statistics made by the 
Operator of the System approximately 10 billion codes have been issued for tobacco products, 2 
billion codes for shoes, 900 million for pharmaceuticals, about 3 .5 million codes for textiles. Taking 
into account these figures, we state that market participants adapted to the system, its functioning 
is stable, for this reason all the negative forecasts in respect of disruption of traditional trade flows 
due to the T&T System are not confirmed. Moreover, the great volume of smuggled tobacco products 
has been recorded in the internal market of the Russian Federation. The relevant analytical 
companies considering the data from 600 ,000 online cash registers made a conclus ion that the illicit 
market of cigarettes is developed in many regions of the Russian Federation. The average price of 
smuggled cigarettes is lower and the circulation of such products is not surveilled. This situation 
causes the negative impact on both co nsumers, and faithful suppliers, due to the fact that smuggled 
products have the relevant competitive price advantages that increase demand on such cigarettes. 
The T&T  System is aimed at eliminating such kind of practice and encouraged to clean the market.   
1.246.   We note hereby the current timeline of entry into force of T&T for next products: for shoes 
T&T enters into force from 1 July 2020; for pharmaceuticals the system enters into force from 1 July 
2020; for cameras the date of entry into force is 1 October 2 020; for tyres the System is supposed 
to enter into force since 1 November 2020; for textiles the T&T is currently supposed to enter into 
force from 1 January 2021; for perfumes from 1 October 2020. Till 30 September 2021 the stocks 
should be coded; dairy products from 20 January and 1 October 2021. We note hereby that the 
guidelines for each type are available on "Chestniy Znak ". As for challenges faced by small 
enterprises, we note hereby that importers ensure appliance T&T in respect of products either a t 
any stage of supply chain from production to imports or at the customs warehouse when products 
are placed under the customs procedures. In this regard, importers and exporters of products to the 
territory of Russia determine the mechanism of application of the System.  G/TBT/M/81  
 
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  1.3.20   European Union – Chlorothalonil (pesticide active substance) , G/TBT/N/EU/625  
(IMS ID 57951) 
1.247.   The delegation of Costa Rica  provided the following statement. Costa Rica reiterates the  
request raised in documents G/SPS/GEN/1778  and G/TBT/GEN/296  – Request  for the Suspension 
of the Processes and Entry Into Force of Reductions of Maximum Residue Levels (MRLs) for Plant 
Protection Products in Light of the COVID -19 Pandemic . 
1.248.   The delegation of Panama  provided the following statement. Through this communication, 
Panama w ill address the concerns about STC ID 393: Ha zard-based approach to plant protection 
products and setting of import tolerances; STC ID 580: European Union - Transitional periods for 
maximum residue limits (MRLs) and international consultations; and STC ID 579: European Union - 
Chlorothalonil (pesticide active substance).  Article 2.2 of the TBT Agreement clearly states that 
"Members shall ensure that technical regulations are not prepared, adopted or applied with a view 
to or with the effect of creating unne cessary barriers to international trade. For this purpose, 
technical regulations shall not be more trade -restrictive than necessary to fulfil a legitimate 
objective, taking account of the risks non -fulfilment would create". However, we note that the 
measur es taken by the European Union go beyond what is necessary to achieve their aims, especially 
when these deviate from the guidelines of Codex and other international organizations under the 
premise of inconclusive studies.  
1.249.   In its notification G/TBT/N/EU/625  for the non -renewal of chl orothalonil, paragraph 7.3 
states that no conclusive results were found. This is clearly the use of the principle of hazard, rather 
than of risk, as is required in the SPS Agreements. Similar cases of the use of the principle of hazard 
have appeared in oth er EU notifications of other substances submitted to the SPS and TBT 
Committees. We take this opportunity to recall that Article 3 of the SPS Agreement states that 
Members should try to harmonize their measures to improve the predictability of trade and, p ursuant 
to Article 3.4, they should draw on the support of the relevant international organizations.  While 
every Member is free to take necessary precautions for the safety of its citizens, these measures 
should not be unduly strict to the point of adverse ly affecting trade. In addition, there must be 
conclusive scientific evidence, as stipulated in Article 5 of the SPS Agreement. It is of concern to us 
that inconclusive European Union studies have resulted in the blocking of active substances, the use 
of which is permitted, regulated by international institutions and essential in the rest of the world.  
1.250.   The substance chlorothalonil, specifically, is an essential organic compound for fighting 
disease in plantain and banana crops, such as Black Sigatoka, cause d by the fungus Mycosphaerella 
fijiensis Morelet . Black Sigatoka initially attacks  plantain and banana plants visibly, presenting as 
black spots on the leaves; it later halves plant production, and then in most cases it destroys 100% 
of sales of the fruit.  This disease worsens with global warming, rain and humidity, which are climatic 
events observed 365 days of the year in tropical countries, a climatic situation that is quite different 
from that found in Stockholm or Madrid. Panama has already had to figh t this fungus before, to the 
point where in many parts of the world Black Sigatoka was known as the Panama disease, although 
we always point out that it first appeared in Fiji. It was thanks to phytosanitary measures that we 
were able to fight it successfu lly; however, we are again at risk in 2020, with inputs in use beginning 
to be blocked and the Earth's highest temperatures being recorded.  
1.251.   Alternatives to chlorothalonil are substances such as mancozeb, the non -renewal of which 
the EU also declared in its  notification G/TBT/N/ EU/712. Studies involving tomatoes, potatoes, 
cereals and grapes, and all fruit with pulps of lesser thickness than bananas, are specifically 
mentioned in this notification. Yet again, without obtaining scientific evidence on all products, the 
substance has been blocked. We recall that, unlike with tomatoes, grapes and potatoes, the peel of 
a banana is not consumed; individual studies should therefore be made into this type of product, 
taking account of its differences. Furthermore, in Panama's banana packing  plants, this fruit is 
carefully washed and sanitized following food safety protocols.  
1.252.   The European Union measures could cause heavy losses and threaten the well -being and 
employment of thousands of families belonging to the Ngäbe Buglé ethnic group, who a re the main 
source of labour for the banana plantations of Changuinola and Puerto Armuelles. In 2017, the trade 
in bananas between Panama and the European Union exceeded 17  million boxes, equivalent to 
USD 180 million, bananas being the main income -produci ng product in the Ngäbe Buglé region. 
 
51 For previous statements follow the thread under IMS ID  579 (under dates raised and references) . G/TBT/M/81  
 
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  Moreover, any impact on this activity would mean a step backwards in the country's struggle to 
improve its production and combat climate change.  In reference to transition periods, the European 
Union talks of periods o f six months. However, banana production typically lasts from 9 to 12 
months, without taking into account the transit time for fruit from origin to destination and finally to 
the point of sale. In other words, during the process of adapting cultivation met hods to the new 
measures, losses amounting to more than a year's production could be generated.  
1.253.   On 12 May 2020, Panama, together with a dozen other Members, submitted document 
G/TBT/GEN/296 , requesting Members to suspend the entry into force of the new maximum residue 
limits for plant protection products during the COVID -19 pandemic. We thank the European Union 
for being supportive and responding to this request on a temporary basis. During this time, we can 
continue discussions on how the EU can take health measures in line with the SP S and 
TBT Agreements without unduly interrupting international trade. However, our choice is to seek 
solutions that would allow all Members to support each other in harmonizing our legislation, with the 
aim of safeguarding human, animal and plant health wi thout imposing unnecessary unilateral 
barriers to trade.  
1.254.   The delegation of El Salvador  provided the following statement. El Salvador shares the views  
expressed by other delegations regarding the negative impact that this measure will have on exports 
of Sal vadorian agricultural products and those of many developing countries to the European market . 
We would also like to register our concern about the various European Union draft technical 
regulations  on maximum residue limits . We urge the  EU to ensure that t hese are based  on technical  
evidence and do not result in unjustified restrictions on trade . Lastly, we refer to the communication 
that has been circulated as document  G/TBT/GEN/296 , sponsored by the delegations of C osta Rica, 
Guatemala, the Dominican Republic, Colombia, Argentina, Pan ama, Ecuador, Paraguay, Per u, 
Nicaragua, Honduras, Israel and El Salvador, in which the European Union is requested to suspend, 
for a period of 12 months, MRL review processes under way  and the entry into force of all reductions 
of MRLs planned for 2020.  
1.255.   The delegation of the Dominican Republic  provided the following statement. The 
Dominican  Republic wishes to reiterate its concern and add to the statements of other Member 
States on this item of the agenda , on the measure notified by the European Union thro ugh document 
G/TBT/N/EU/625 , relating to the non -renewal of the authorization for the active substance 
chlorothalonil.  These measures will cause serious problems for our exports, mainly for banana, 
mango and avocado exports, which represent around 20% of total annual food exports, wi th the 
countries of the European Union being their main market . These types of measures have a direct 
socioeconomic impact not only in the Dominican Republic but throughout the region . We consider 
that this measure was adopted without taking into account t hat this substance is used in many of 
the producing countries and the European Union has so far been unable to produce conclusive 
scientific evidence to demonstrate  that chlorothalonil represents any risk to health or the 
environment , contra ry to the provi sions of Article 2 of the TBT Agreement . It must be remembered 
that the WTO 's TBT Agreement provides that any measure introduced  by a Member  State  cannot be 
more trade -restrictive than necessary and must not become an unnecessary barrier  to trade. It is 
for these reasons that we request the EU to maintain the registration of chlorothalonil . We request  
the EU to re -establish the registration of this substance and to carry out an a ppropriate  risk 
assessment to demonstrate its true effects on public health, or  to abide by the provisions of Codex 
Alimentarius, which establishes MRLs for chlorothalonil for various  agricultural practices.  
1.256.   The delegation of Colombia  provided the following statement. Colombia wishes to reiterate  
its concern regarding the measure notified by the E uropean Union in document G/TBT/N/EU/625  
relating to the  non-renewal of the approval of the active substance chlorothalonil. This substance is 
key to pest control for a wide variety of crops, particularly bananas, since it is used for the control 
of Black Sigatoka, a  fungus that devastates banana crops.  The EU has been adopting measures 
leading to the non -approval of the use of products for plant protection that is affecting the exports 
of its trading partners.  The m easures for the suspension or non -approval of the marketing  of a 
number of  active substances , and the subsequent reduction of their MRLs to the minimum detection 
level, are being taken without  any solid scientific evidence and without demonstrating  that they are 
the least trade -restrictive means of achieving an appropriate  level of protection for cons umers.  In 
Colombia, the use of certain active substances  such as chlorothalonil is indispensable in agricultural 
production for the protection of crops against pests and diseases, and for maintaining the quality 
and safety of products during storage, trans port and distribution, before they reach consumers on 
the European market.  G/TBT/M/81  
 
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  1.257.   It is important to note that, regarding the review of substances , EFSA has published, as it 
has done more and more frequently, reasoned opinions stating that, owing to insufficient  
information, the risk assessment for active ingredients is inconclusive. This situation has been 
wrongly interpreted by the European Commission (DG SANTE), which, as a precaution, has not 
renewed the marketing permits for the substances . Contrary to the p rovisions of the WTO 's TBT 
Agreement, the EU's decisions are not provisional and do not demonstrate any effort to obtain the 
further information necessary to conduct a more objective risk assessment.  The foregoing 
constitutes a violation of Article 2.2 of the TBT Agreement, which stipulates that "technical 
regulations shall not be more trade -restrictive than necessary to fulfil a legitimate objective ". As 
indicated, there is insufficient information to establish criteria for acceptance or rejection of the 
chlorothalonil compound, given that, from a scientific point of view, its effect on health has not been 
clearly determined.  
1.258.   We reiterate that it is essential for the EU to use a risk -assessment approach in decision -
making to determine marketing approvals for active substances , as the EU has stated in a similar 
context, given that  there is insufficient scientific evidence to identify  the various toxicological aspects 
that may affect hum an health , or the environment in the case of chlorothalonil . Any measures 
adopted must be  based on scientific evidence and international standards and take account of the 
biodiverse agriculture of countries such as Colombia, which cannot be compared with t hat of 
European latitudes, where the climatic conditions and seasons are very different. This is in 
accordance with the terms of the WTO's TBT Agreement, which provides that any measures 
established should  not be more trade -restrictive than necessary or cr eate unnecessary barriers  to 
trade.   
1.259.   In May , in compliance with the standard published by the EU , the transition period for the 
marketing of the substance ch lorothalonil  expires , and can no longer be used , despite the fact that 
various Members have been ra ising concerns in this Committee  for over a year, to which we have 
received no response from the EU . Moreover, the situation arising from the COVID -19 global health 
emergency has forced the health and scientific authorities of all countries, including Colo mbia, to 
focus attention on that situation . By the same token, key sectors such as food producers, 
organizations and associations are having to make significant efforts to ensure biosecurity controls 
in the fruit and vegetable supply chain. This is reducin g their capacity to analyse draft regulatory 
measures and adjust production methods, creating additional burdens on international food trade, 
which is hampering worldwide economy recovery efforts, especially in developing countries. In line 
with the statem ents made in document  G/TBT/GE N/296  of 12 May, we request the EU to suspend 
for a period of 12 months all review processes of market approvals for plant protection substances, 
and the entry into force of regulations in this area, planned for 2020, including the non -renewal of 
the activ e substance chlorothalonil . 
1.260.   The delegation of Ecuador  provided the following statement. We would like to refer Members  
to documents G/TBT/W/649 , G/TBT/W/688  and G/TBT/W/717 , which contain the statements made 
by Ecuador on this matter du ring the meetings of this Committee held in June and November 2019 
and February 2020. As has previously been stated , the non -renewal of the approval of the active 
substance chlorothalonil in the European market, as well as the subsequent reduction of maxim um 
residue levels (MRLs) for this product, will have  a serious impact on the production and marketing 
of bananas. Despite agribusiness being considered a strategic sector of the economy that can 
continue its operations in Ec uador, the health emergency has had an impact on  the banana sector. 
In addition to the high number of people who have become ill  and been hospitalized by COVID -19, 
government measures imposing  mandatory confinement and restriction s on movement to reduce 
the number of infections also create complications across  the logistics chain due to staff shortages , 
and have an impact on production and export volume. All of this has had an economic impact , 
causing  cash-flow problems for some producers and exporters. It is worth noting  that 78.5% of th e 
Ecuadorian banana sector is made up of small producers, wh ich have been more heavily affected by 
the emergency.  
1.261.   EU measures limit ing the use of key phytosanitary tools such as chlorothalonil pose an 
additional challenge  to existing difficulties caused b y the coronavirus . It is a problem that falls on 
producers and exporters, putting at even greater risk their ability to maintain levels of production, 
comply with delivery program mes as per c ontracts, guarantee the supply of fruit in the different 
markets and ensure employment  in the sector.  This month, the transition period for the marketing 
of chlorothalonil in the EU comes to an end, and it will no longer be possible to use the substance . 
In the context  of the health emergency , the process of looking for replacements for chlorothalonil G/TBT/M/81  
 
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  will take longer  because field tests are being hampered by infection prevention protocols . Given that 
there is currently no effective alternative, this could potentially lead to a 10 -15% wastage in fruit 
due to pests . 
1.262.   Ecuador submitted comments on EU notifica tion G/TBT/N/EU/625 . In its reply, dated 
5 February  2019, the EU indicated that the assessment conducted by EFSA did not provide 
conclusive scientific data showing that metabolites of  chlorothalonil will contaminate groundwater or 
have genotoxic effects on consumers. As a result, and to avoid unnecessarily disrupting food 
production in developing countries, Ecuador once again requests that the EU, prior to making a 
decision to reduce M RLs for any plant protection product, including for chlorothalonil, conduct a risk 
assessment in accordance with the provisions of the Agreement on Sanitary and Phytosanitary 
Measures and maintain current MRLs until there is full scientific data to support  the setting of MRLs 
different from those established by Codex Alimentarius. We also reiterate the content of the joint 
statement that was circulated to this Committee and to the SPS Committee as document  
G/TBT/GEN/296  on 12 May, through  which a group of developing Members urged  the EU to suspen d 
for a period of 12 months its measures under way to restrict the use of plant protection substances, 
including chlorothalonil.  
1.263.   The delegation of Nicaragua  provided the following statement. The delegation of Nicaragua  
associates itself wi th the concern raised by other Members regarding the measure notified by the 
European Union in document  G/TBT/N/EU/625 , of 4 December  2018, referring to the non -renewal 
of the approval of the active substance chlorothalonil. This substance is used by farmers as a 
fungicide to control  certain pests that have a significant impact on food production.  Nicaragua 
recognizes the right of a ny Member to determine the appropriate level of sanitary or phytosanitary 
protection necessary to protect the health and lives of human s, animal s or plant s. In this regard , 
priority and impetus should be on the establish ment of measure s that are  science -based and do not 
create unnecessary barriers to trade. Nicaragua also reitera tes the r elevanc e of Codex  Alimentarius 
as the relevant body for a fair and safe  food trade . It therefore urges the European Union to ensure 
that the measures established are based on scientific evidence and international standards,  in 
accordance with the WTO's TBT Agreement . 
1.264.   Nicaragua associates itself with the request to maintain the approval of chlorothalonil in the 
European Union and with the other concerns previously expressed by other M embers. The 
implementation of these measures will have a negative impact on national production sectors , which 
would face difficulties if the authorization for chlorothalonil was not renewed , and it would also affect 
the export of products to the European Union. In addition , we co -sponsored with other Members 
document G/TBT/GEN/296  "Request for the suspension of the processes and entry into force of 
reductions of maximum residue levels (MRLs) for plant protection products in light of the COVID -19 
pandemic ". Through this document, we respectfully request the European Union to suspend for a 
period of 12 months the application of its new MRL regulation(s) , taking into account the negative 
impact  that the current pandemic has had on global supply chains, food production and the 
econom ies of farmers in developing economies . 
1.265.   The delegation of Paraguay  provided the following statement. We would like to thank the  
delegations that included this topic in today's agenda and to reiterate our concern . As we have 
already stated on previous occasions, in my country , chlorothalonil is classed as a low -risk pesticide 
and is sold freely. It is used in  several  key export products as part of the rotation of substances to 
avoid resistance to other main substances. One of the alternatives currently available to replace 
chlorothalonil is mancozeb, which is the subject of another specific trade  concern today because the 
EU has decided to treat it in the same way as  chlorothalonil.  We do not share the EU's criteria for 
not renew ing the of use of substance s because studies are inconclusive , and we urge the EU to 
complete such studies and carry out  a risk assessment, in accordance with international principles 
and standards on the subject. Furthermore , we once again  urge the European Union to comply with 
the international commitments that it has undertaken within this Organization and to ensure import 
tolerance s. 
1.266.   The delegation of Guatemala  provided the following statement. We would like to thank  
Costa  Rica, Panam a, El Salvador, the Dominican Republic and Colombia for including the topic in the 
agenda . Guatemala wishes to express its support for the concern , especially because there is no 
information on the scientific evidence of the damage caused to human health as a consequence of 
consum ing fruits and vegetables produced in particular in Latin America , and that is why it is 
important to carry out a risk analysis. The European Union has previously mentioned that it has G/TBT/M/81  
 
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  identified potentially adverse health effects of the substance. However, the European Union has not 
sent to the countries concerned information on the contamination of imported products  that have 
been assessed  using  available scientific information.  
1.267.   We wish to make clear that our concern over the substance is not because we are producers 
of the substance.  Our concern is about the use of the substance for the control of fungal diseases. 
There is no other fungicide on the market that is as effective in fungi control, in particular for the 
control of Ascochyta, Anthracnosis, Black Sigatoka, brown spot and leaf  spot, downy mildew, early 
blight, late blight, grey mould and fruit rot, which affect the production of snow peas, bananas, 
coffee, melons, cucumbers and tomatoes.  We would therefore appreciate it if the European Union 
would consider the particular circum stances of tropical countries when implementing measures , until 
it has conclusive studies and has aligned itself with the provisions of Codex.  
1.268.   The delegation of Brazil  provided the following statement. Brazil would like to support this 
STC and refer to its  past statements on the issue. We oppose the EU's decision to base measures 
on a hazard -based approach, without an adequate risk analysis and with no compliance with long -
standing scientific principles. The non -renewal of approval for chlorothalonil by the  EU did not duly 
consider that it is currently authorized in more than 100 countries, and that the MRLs allowed by 
CODEX  could reach up to 70  mg/kg. In light of this, we reaffirm our concerns with the fact that some 
hazard -based analyses conducted by the E FSA led to the non -renewal of certificates and 
subsequently to the reduction of MRLs limits. The Brazilian National Health Agency has set MRLs for 
this substance for more than 30 different crops. The case of chlorothalonil affects Brazil' s exports of 
agricultural products, such as banana, coffee, citrus fruits, papaya, watermelon, among other crops 
that use this substance for pest control.  
1.269.   In response, the delegation of the European Union  provided the following statement. The EU 
thanks WTO Members for raisi ng this issue. As explained at previous TBT Committee meetings, the 
EU proposed not to renew the approval of chlorothalonil and notified third countries of the draft 
Regulation via the TBT procedure. The measure did not lead to immediate disruptions in tra de, as it 
does not amend the M RLs and provides for a grace period. The possibility for granting transitional 
measures will be considered when proposing any changes to existing MRLs, which will not take place 
before expiry of the grace period. Furthermore, it is important to reiterate that any action to reduce 
MRLs in the future will be subject to a separate notification under the WTO/SPS procedure. As 
previously explained, chlorothalonil was evaluated in accordance with Regulation (EC) No 1107/2009 
on the p lacing of plant protection products on the market52. The conclusion53 by the E FSA on 
chlorothalonil, following assessment by the "rapporteur " member State and an extensive peer review 
process, was published in January 2018. During this peer review process, t he approval criteria 
provided for in Article 4 of the Regulation were not satisfied with respect to one or more 
representative uses of at least one plant protection product.  
1.270.   During the assessment: a critical concern was identified by the authority  in relat ion to the 
contamination of groundwater by certain metabolites of chlorothalonil54, the authority could not 
exclude a genotoxicity concern for residues to which consumers will be exposed and identified a high 
risk to amphibians and fish for all the uses eva luated, several areas of the risk assessment could not 
be finali zed due to insufficient data in the dossier, and it was noted that chlorothalonil is classified 
as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council, while the conclusion of the Authority indicated that chlorothalonil 
should be classified as carcinogen categ ory 1B. In light of the above, the EU proposed not to renew 
the approval of chlorothalonil in accordance with Article 20(1)(b) of the plant protection products 
Regulation. On 29 April 2019, the Commission adopted Implementing Regulation (EU) No 
2019/67755 concerning the non -renewal of the approval of the active substance chlorothalonil. Grace 
periods shall not be set beyond 20 May 2020. Import tolerance requests however remain possible 
 
52 http://eur -lex.europa.eu/legal -conte nt/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107 . 
53 EFSA 2018 Conclusion on the peer review of the pesticide risk assessment of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126 : http://www.efsa.europa.eu/en/efsajournal/pub/5126 . 
54 In particular, metabolites R417888, R419492, R471811, SYN507900, M3, M11, M2, M7 and M10 are 
predicted to occur above the parametric value of 0.1 μg/L in all pertinent scenarios for all proposed uses of 
chlorothalonil.  
55 OJ L 114, 30.4.2019, p. 15.  
 G/TBT/M/81  
 
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  and will be assessed on a case -by-case basis by the "rapporteur " member S tate and the E FSA. Such 
requests would have to be supported by substantial new data addressing the concerns.  
1.3.21   China – Cosmetics Supervision and Administration Regulation (Draft) and 
Regulation for Notification of Non -special Cosmetics (Draft) , G/TBT/N/CHN/1310 , 
G/TBT/N/CHN/1311 , G/TBT/N/CHN/1331  (IMS ID 57656) 
1.271.   The delegation of the United States  provided the following statement. We understand that 
the State Council passed the C osmetics Supervision and Administration Regulation (CSAR)  draft in 
January 2020. Our industry is pleased that China has chosen to modernize its cosmetics r egulations 
as they believe the resulting reforms could promote the rapidly growing cosmetics trade between 
the U S and China. When do you anticipate that the State Council will publish the Regulation? As 
China develops the CSAR implementing measures, we wou ld appreciate that China continue to notify 
all draft and final measures to the WTO and engage with U S industry. This will help to ensure that 
CSAR promotes innovation and trade while meeting the National Medical Products Administration's 
(NMPA) mandate to  ensure safe products. We understand that the Draft Measures for the 
Registration and Filing of Cosmetics, notified in G/TBT/N/CHN/1311 , may have been amended, 
without notification, to require that certain special -use cosmetics undergo testing in China, even 
when there is test da ta available from international labs that follow good laboratory and clinical 
practices. We ask that China notify these proposed amendments to the WTO and avoid adopting 
duplicative testing and other requirements that may be more trade restrictive than nec essary.  
1.272.   We also trust that China is considering the concerns US  Government  and U S industry have 
raised regarding China's proposed conformity assessment requirements for imported non -special -
use cosmetics notified in G/TBT/N/CHN/1331  and will take these comments into account when 
finalizing the measure. We would welcome a discussion that brings together NMPA, the State 
Administration for Market Regulation, and the Ministry of Foreign Trade and Commerce with US  
Government  officials and  US industry to better understand China's concerns and to find a solution 
that is not more trade restrictive than necessary. The success of China's cosmetics and personal 
care industry is important to the United States given both the number of Chinese prod ucts used 
daily by American consumers, as well as the economic opportunity China represents to U S companies 
seeking to serve China's growing consumer base. The industry provides an example of the potential 
for the expansion of our bilateral trade, given ro bust exports from both countries.  
1.273.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as follows. Korea supports China's objectives of 
assuring the quality and safety of  cosmetics through the revision of this measure. However, Korea 
remains concerned that some of the provisions within the regulations being drafted could create 
unnecessary obstacles to trade. The concerns from our industry are as follows. First, Korea has 
continuously been requesting China to reconsider the disclosure requirement that mandates 
companies to publish evidence for efficacy claims, which includes CBI. However, we found that our 
comments have still not been reflected in the recently drafted regul ations. Thus, Korea would like to 
request China to allow companies to submit evidence for efficacy claims to the Chinese regulatory 
authority only when necessary, or to grant exemption from the disclosure requirements. Second, 
the proposed revision require s over -labels in Chinese to be consistent with the original labels. Korea 
therefore would like to ask China that its labelling requirements be aligned with international 
practices as under the current practice which requires compliance with the labelling r equirements of 
the exporting country.  
1.274.   Third, the regulation stipulates that test results required for the registration of cosmetic 
products must be issued by testing laboratories that have obtained CMA in compliance with the 
regulation. However, only labor atories in China are known to have obtained CMA. Thus, Korea would 
like to request China to offer flexibility to foreign laboratories in granting CMA and to recognize test 
results issued by foreign laboratories or internationally recognized laboratories, i ncluding test reports 
submitted for the registration of cosmetic products. Fourth, under the draft of "Cosmetics 
Supervision and Administration Regulation, " the licen ce for special -use cosmetics has validity 
periods. The licen ce issued by most of the count ries including Korea, the U S, and European states 
do not have a determined validity period. To harmonize cosmetics regulations, Korea requests that 
China reconsider setting the validity periods of the licen ce for special -use cosmetics. Korea invites 
China to give full consideration of our comments in reviewing the draft regulations and looks forward 
 
56 For previous statements follow the thread under IMS ID  576 (under dates raised and references) . G/TBT/M/81  
 
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  to China's response on this matter. We also would like to ask China to share with us the enforcement 
date of this proposed regulation and provide sufficient tra nsition period to allow time for the Korean 
industry to prepare for the new regulation. Lastly, we understand that the revised regulation was 
adopted by China's State Council on 3 January 2020 and request the information about when the 
regulation will be p ublished.  
1.275.   The delegation of Australia  provided the following statement. Australia reiterates that we 
would welcome an update from China on the C SAR. We would particularly welcome details with 
respect to the status of the CSAR, timelines for implementation and how it would work in practice. 
We have seen reports that China's State Council formally passed the CSAR on 3 January 2020. Could 
we please see a copy of the latest text of the CSAR and will China publish and formally notify WTO 
Members prior to publica tion of the CSAR? Does it remove, or provide an alternative to, the 
requirement for imported cosmetics to be tested on animals? What certification requirements does 
China envisage for imported cosmetics? We are interested in knowing more about the concept of 
mutual recognition as mentioned by China at the November 2019 TBT Committee meeting. China 
should provide equal treatment for Chinese and foreign cosmetics products, and be no more trade 
restrictive than necessary when implementing any measures to ensur e the safety of cosmetics. We 
would urge China to notify the final version text of the CSAR through the WTO, noting particularly 
our interest in understanding any new measures that other WTO Members would be required to 
comply with. We would welcome the op portunity to engage bilaterally in discussion on cosmetics 
regulation and alternatives to animal testing.  
1.276.   The delegation of Japan  provided the following statement. With respect to China's proposed 
amendments to "CSAR" and related detailed regulations, we c ontinue to have the following concerns. 
Regarding disclosure of new ingredients and efficacy testing materials, Japan requests that the scope 
of disclosure be clarified so as to exclude confidential corporate information. Regarding the labelling 
content re quirements, it is provided that the information written on added Chinese labels shall be 
consistent with the original labels. However, the original labels are designed to comply with 
regulations in the country of origin and it is natural that their content s do not always comply with 
China's regulations. In the draft, multiple stakeholders, such as "cosmetics producers and operators " 
and "cosmetics registrants or filers ", are noted as the persons responsible for quality and safety of 
cosmetic products. In or der to avoid confusion, Japan requests that the amended regulation clearly 
establish only one legally responsible person (a legal or a natural person) and considers that the 
label should indicate a single responsible person.  
1.277.   Furthermore, Japan still has co ncerns related to the "Regulation on Cosmetic Inspection in 
Registration and Filing ". We would like to reiterate the following three points. Regarding testing 
laboratories China's regulations do not recognize test results obtained by in -house or foreign 
laboratories. Japan requests a more flexible framework in which test results obtained by in -house 
or foreign laboratories through internationally recognized practices such as ISO can be accepted. As 
for the efficacy evaluation, China has not provided detaile d information regarding test methods 
required for whitening products. Since whitening tests take a long time to complete, Japan requests 
that test results obtained by in -house or foreign laboratories be accepted and the grace period be 
adequately extended.  As we mentioned at the last TBT meeting, in terms of requirements for animal 
testing, there are conflicting descriptions between "Regulation on Cosmetic Inspection in Registration 
and Filing " and "Regulation for Notification of Non -special Cosmetics ". Japan requests that China 
ensure consistency between those regulations.  
1.278.   Moreover, regarding "Interim Measures on the Administration of Overseas Inspections of 
Cosmetics ", Japan would like to continue to express concerns on the following three points. The draf t 
measures appear to lack a concrete legal basis and a specifically stipulated purpose for overseas 
inspections. Japan would like to request that China clarify which laws and regulations authorities are 
to use to determine conformity and specific purposes for conducting inspections. Japan also asks 
that China ensure that inspections will not be more trade restrictive than necessary, ensuring that 
the legitimate objectives under the TBT Agreement are fulfilled. The coverage of the inspection 
including produc t development stage is broader than necessary. In Article 10 and Article 32 of this 
draft, the main purpose of the inspection seems to be to ensure product safety. Information related 
to research and development is not necessarily essential for product saf ety assurance, while it is the 
most confidential information for companies and therefore Japan requests that the scope of this 
information be limited to essential items. In addition, extensive inspections with unclear objectives 
can place unnecessary burde ns on companies, since various companies are involved in the process 
from research and development to sales. Therefore, R&D departments of companies should be G/TBT/M/81  
 
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  excluded from the coverage of overseas inspections. Furthermore, inspections for Chinese domestic  
companies are only conducted on production sites. Japan would like to request that China provide 
equal treatment to both domestic and overseas companies. Japan requests that China ensure that 
confidential information will not be disclosed to anyone other than those who are necessary for the 
legitimate purpose of the inspection, since production sites also contain the confidential information 
of companies.  
1.279.   Finally, we would appreciate it if China could provide the detailed timeline for these revision 
proce sses. Japan requests that China provide an adequate grace period of at least one year for 
implementation of these regulations and the related detailed regulations to avoid confusion in the 
market. We also hope that China will notify the latest revised regu lation to the TBT Committee as 
China stated at the previous meeting that they had made some adjustments to the draft regulation 
taking into account WTO Member comments.  
1.280.   In response, the delegation of China  provided the following statement. The C SAR aims to 
ensure the quality and safety of cosmetics, safeguard the customers' health and promote the 
development and innovation of this industry by regulating cosmetic production and operation 
activities, strengthening the administration and supervision of  cosmetics management. This 
regulation was notified to WTO in December of 2018 and has been adopted by China State Council 
on 3 January 2020. Regarding the Regulation of Notification of Non -special Cosmetics, the technical 
requirements and safety standards  are the same on imported and domestic products, both are 
subject to consistent supervision management. Since 10 November  2018, the method of approval 
administration of the imported non -special cosmetics has been adjusted to recordation 
administration. Chi na will further strengthen information exchange and cooperation with Members 
and improve the cosmetics supervision system.  
1.3.22   Qatar – Ministry of Public Health Circular regarding shelf life for cheese (IMS ID 
60257) 
1.281.   The delegation of the European Union  provided the following statement. The European Union 
would like to recall its concerns with regard to the Qatar Ministry of Public Health  Circular of 30 May 
2019 establishing new import requirements for UHT milk and white cheese that entered into force 
the following day, on 1 June 2019. The EU regrets that Qatar did not notify these requirements to 
the WTO under neither the TBT nor the SPS Agreements. The implementation of these rules is 
causing serious disruptions to EU exporters as compliance with these requirements is not feasible 
for certain cheeses and milk products. As a consequence, EU products covered by the measure 
cannot be exporte d to Qatar anymore. The EU is particularly concerned about the stringent 
restrictions on the shelf  life that disadvantage imported products in comparison to local products, 
but also about certain product characteristics for UHT milk and white cheeses, in p articular obligatory 
addition of vitamins to milk and low -fat-only requirement for certain white cheeses.  
1.282.   These requirements are not in line with C odex Alimentarius relevant international standards, 
are not science -based and do not guarantee the safety of imported products. The measures therefore 
appear to be more restrictive than necessary to fulfil the legitimate objective of public health 
protection. In this context, the EU would like to refer to Articles 2.1, 2.2 and 2.4 of the TBT 
Agreement. The EU wou ld like to invite Qatar to suspend the application of the measure without 
further delay, align it to the WTO rules and comply with its notification obligations. The EU would 
like to thank Qatar for bilateral exchanges during the past months, which unfortun ately have not yet 
resulted in an effective solution. The EU is prepared to continue to work constructively with Qatar to 
resolve this important issue.  
1.283.   The delegation of the United States  provided the following statement. The United States 
remains concerne d over Qatar's dairy product regulation, published by the Ministry of Public Health 
on 30 May 2019, which restricts the reconstitution of milk and shelf life of cheeses, among other 
things. The United States is also concerned with Qatar's adoption of this measure without notifying 
it to the W TO, providing trading partners the opportunity to comment, or a reasonable 
implementation period. The United States understands that the measure may in fact be considered 
a temporary measure. In light of this new inform ation as well as the U S request to suspend or amend 
the measure, can Qatar provide additional details regarding the plans to withdraw or update the 
measure, including any plans Qatar has to notify it to the WTO? Despite Qatar's willingness to meet 
 
57 For previous statements follow the thread under IMS ID  602 (under dates raised and references) . G/TBT/M/81  
 
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  with the  United States bilaterally, U S exporters continue to face market uncertainty due to the 
enforcement of this measure, indicating that they are unable to obtain future contracts and are 
expecting to lose their business in Qatar as soon as current contracts a nd supplies end. The United 
States therefore reiterates our request for Qatar to continue its engagement with the United States 
on this measure and work to immediately resolve the market uncertainty this non -notified measure 
has created.  
1.284.   The delegation of Canada  provided the following statement. Canada would like to join the 
United States and the European Union to reiterate its concerns with Qatar's shelf -life requirements 
for identified milk and cheese products established by the Ministry of Public Health on 30 May 2019. 
As stated in the previous TBT Committee meeting, Canadian exporters of paneer cheese are unable 
to fulfil existing contracts with Qatar importers due to the overly restrictive shelf -life requirements 
for paneer cheese. The 50 -55 day ocean t ransit from Canada to Qatar effectively makes it impossible 
to comply with these new 45 -day shelf -life requirements. We remain concerned that these stringent 
shelf-life requirements effectively encourage the domestic or close proximity sourcing of these 
products which potentially leads to the discriminatory treatment of imported products.  
1.285.   Canada once again encourages Qatar to notify this measure to the WTO, pursuant to the 
WTO's transparency obligations, in order to provide trading partners with the opport unity to 
comment. Until then, we respectfully request that Qatar suspend its implementation. Subsequent to 
the last TBT Committee held in February 2020, Canada submitted its detailed questions through 
Qatar's Enquiry  Point on 26 March 2020 to obtain additi onal clarifications on the measure and to 
highlight our specific concerns. We recognize that existing processes could be temporarily disrupted 
due to the current global pandemic. When circumstances permit, we would appreciate if Qatar could 
acknowledge rec eipt of our questions and inform when a response can be expected. In the 
meantime, Canada will continue to follow these discussions closely, and looks forward to continued 
engagement with Qatar.  
1.286.   In response, the delegation of Qatar  provided the following s tatement. Qatar has taken note 
of the continued concern of the United States, the European Union, and Canada regarding Qatar's 
Ministry of Public health circular on shelf life for cheese and thanks them for their interest. We are 
following this matter with  the competent authorities in Doha. We would like to take this opportunity 
to reconfirm that these measures have been adopted to ensure the quality of products available in 
Qatar, and that the protection of consumers is of primary importance to the Governm ent of the State 
of Qatar with its international obligations under the WTO Agreements,  including the TBT Agreement. 
Also, we would like to assure Members that the relevant measures apply equally to domestic and 
imported products and are therefore non -discriminatory in nature. Furthermore, any impact that 
such regulations may have on trade will not be more than necessary to contribute to the fulfil ment 
of the legitimate objective of protecting consumers. In this respect, we would like to emphasize that 
produ ct-specific requirements applied in the State of Qatar do not prevent the importation and sale 
of any products that meet quality standards and thus do not have a significant effect on trade. This 
being said, we will share the concerns expressed here with o ur capital and will provide replies to the 
questions we have received as soon as possible. Also, we remain available to continue our 
constructive discussion with the interested members to provide additional explanation where 
necessary.  
1.3.23   Mexico – Draft Amend ment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic 
beverages , G/TBT/N/MEX/178/Add.9 , G/TBT/N/MEX/178/Add.10 , 
G/TBT/N/MEX/17 9/Add.11  (IMS ID 60858) 
1.287.   The delegation of the United States  provided the following statement. The United States 
supports Mexico's public health objective of reducing diet -related non -communicable  diseases and 
appreciates Mexico's notification of NOM -051, "General Label ling Specifications for Pre -Packaged 
Foods and Non -Alcoholic Drinks – Commercial and Health Information. " We appreciate the bilateral 
discussions we have had with Secretary of the Economy, Undersecretary de la Mora, her staff, and 
the authoriti es of the Dirección General de Normas (DGN), Comision Nacional de Mejora Regulatoria 
(CONAMER), and Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). We are 
very concerned that phase one of implementation for these requirements is c urrently scheduled to 
begin on 1 October 2020, approximately six months after the final regulation was published. We 
 
58 For previous statements follow the thread under IMS ID  608 (under dates raised and references) . G/TBT/M/81  
 
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  request that Mexico allow for a transition period of at least two years prior to initiating phase one of 
implementation. We emphasize the n eed for an extended transition period in light of the COVID -19 
global pandemic, which has placed significant pressure on the food and beverage industry to 
maintain supply of safe and affordable food and manage complex global supply chains. More 
flexibility  in food production and label ling is needed at this time rather than diverting critical 
resources to comply with label ling rules aimed at longer term public health goals. A delay in the 
implementation of these rules to allow a two -year transition period wo uld enable the industry to 
remain focused on manufacturing during this crisis.  
1.288.   The United States Government and nine trade associations provided comments on the draft 
regulation through the United States Enquiry Point. We were disappointed to see that the US 
government's concerns were not addressed in the final revised measure. The United States remains 
concerned that the revised regulation, intended to address public health, may be more trade 
restrictive than necessary to meet Mexico's legitimate health ob jectives, may not be based on robust 
scientific evidence, does not appear to consider the relevant international standards, and may 
contribute to consumer confusion. Among our many concerns for this measure, we would like to 
highlight some of them today . We continue to be concerned that Mexico has chosen more stringent 
nutrient thresholds than the thresholds set by other countries. For example, the proposed threshold 
for sodium is lower than the thresholds set by Uruguay and Chile. Mexico has derived its th resholds 
from the World Health Organization's Population Nutrient Intake Goals to Prevent Obesity and 
Related Non -Communicable Diseases. The WHO goals relate to an individual's total diet. When 
applied to individual foods the threshold may be more conserva tive than necessary. This application 
may discourage intake of food groups important to recommended diet patterns, which may lead to 
skewed dietary patterns and potentially lead to deficiencies of essential nutrients.  
1.289.   We understand that per Chapter 9 of th e regulation, while products must comply with the 
regulation and standards, conformity assessments will be voluntary. Can Mexico please confirm that 
label approval and conformity assessment of all products subject to the regulation is intended to be 
volunt ary? We note that Mexico's definition of dietary fib re in this measure includes non -digestible 
carbohydrate polymers (including those that are synthetic or that have been isolated or purified from 
food raw material) which "have been shown to have a benefic ial physiological effect on health 
through generally accepted scientific evidence. " Can Mexico clarify whether the definition of dietary 
fibre in NOM -051 is intended to include non -digestible carbohydrate polymers that show a beneficial 
physiological effec t with between three and nine monomeric units, or only non -digestible 
carbohydrate polymers with 10 or more monomeric units? Given that this measure could affect up 
to USD 3.4 billion in trade from the United States to Mexico, we hope you continue to consi der 
government and stakeholder input before implementing the regulation.  
1.290.   The delegation of Costa Rica  provided the following statement. Costa Rica wishes to support  
the trade concern raised by the European Union , the United States, Switzerland and  El Salva dor 
regarding Mexico's proposed front -of-pack nutrition labelling for food products . In recent years , 
Costa Rica ha s very much believed in, and defended, the importance of the work carried out within 
the Codex Alimentarius framework,  and has given equal im portance to scientific justification for the 
measures adopted by each country, whether they be based on the Codex itself or on other technical 
or scientific evidence, as required by the Agreement on Technical Barriers to Trade . Given that the  
Codex Aliment arius is currently developing working materials on front -of-pack nutrition labelling , 
Costa Rica wishes to request once again that the Mexican delegation clarify its position regarding 
the work carried out in the Codex in this area . 
1.291.   With regard to the measure itself, and bearing in mind that the classification parameters 
according to which a product is considered to contain excessive calories, sugar, saturated fats, trans  
fats or sodium are not Codex -based , we reiterate the request made to the Mexican d elegation at 
this Committee's previous meeting, to indicate the scientific basis or international reference standard 
used to define the key parameters for Mexico's classification  and to provide relevant justification for 
the use of the front -of-pack warnin g sign as supplementary nutrition information . Regarding the 
consumption by children of products containing added caffeine or sugar substitutes , Costa Rica 
requests the delegation of Mexico to refer to the international reference standard used, or the risk  
analysis, which establishes the risk posed to children by the consumption of products containing 
these ingredients . Costa Rica believes that the measure adopted by Mexico could generate 
inconsistencies with TBT  Agreement obligations, in particular those e stablished in Article  2.2 and 
2.4. It is Costa Rica's view that as things currently stand worldwide in light of the COVID -19 
pandemic, the implementation of certain sanitary and phytosanitary measures that create additional G/TBT/M/81  
 
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  restrictions or burdens , without  prejudice to the power that Members have to adopt them if 
considered necessary , constitutes a challenge that hampers econom ic recovery efforts , especially in 
developing countries like ours. In light of the foregoing, we would be grateful if the Mexican 
delegation could inform us about the progress of this regulatory draft . 
1.292.   The delegation of the European Union  provided the following statement. The European Union 
would like to thank Mexico for the opportunity to send written comments on the notification 
G/TBT/N/MEX/178/Ad d.9 Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic beverages. The 
EU notes that the final measure was published on 27 March 2020 and appreciates the publica tion of 
the reply to the comments received on the draft amendment. The European Union supports and 
shares the objective of Mexico to inform the consumers clearly and truthfully of the content of critical 
nutrients presenting health risks in excessive consu mption. However, to minimi ze negative impact 
on trade, the European Union would like to reiterate its main concerns. The EU notes that phase one 
of implementation of the measure should begin on 1 October 2020. EU food producers report that 
this period woul d not be sufficient to adapt their production and labelling practi ces to the new 
requirements. The European Union would like to ask Mexico to consider allowing for a longer 
transition period of at least two years prior to initiating phase one of implementa tion. 
1.293.   The definition of "dietary fibre " mentioning "three or more monomeric units " is not fully in 
line with the definition in section 2 of the Codex  Guidelines on Nutrition Labelling mentioning "ten or 
more monomeric units ". Therefore, the EU proposes to bring the definition in line with the C ODEX  
guidelines. Furthermore, section 4 of the notified draft provides specific requirements concerning 
the indication of sugars in the list of ingredients. These requirements do not provide the same 
flexibility as se t out in the Codex General Standard for the Labelling of Prepackaged Foods (CXS 1 -
1985). The sugar content is also indicated in the mandatory nutrition declaration required by the 
notified draft. The EU would suggest that Mexico maintains the flexibility p rovided for in the C ODEX  
standard to list the ingredients in descending order of weight, without introducing further specific 
requirements for the indication of sugars in the list of ingredients.  
1.294.   The notified draft also provides that substitute products mu st add the statement 
"SUBSTITUTE PRODUCT " to the upper left of the main surface of the label. In the EU, a different 
approach has been taken to ensure that the consumers are properly informed, while at the same 
time leaving a certain flexibility for the operators. Regulation (EU) No 1169/2011 on the provision 
of food information to consumers59 requires that "In the case of foods in which a component or 
ingredient that consumers expect to be normally used or naturally present has been substituted with 
a different component or ingredient, the labelli ng shall bear – in addition to the list of ingredients – 
a clear indication of the component or the ingredient that has been used for the partial or whole 
substitution: (a) in close proximity to the name of the product; and (b) using a font size which has 
an x-height of at least 75% of the x -height of the name of the product and which is not smaller than 
the minimum font size required in Article 13(2) of this Regulation. " The EU would like to ask Mexico 
to align the nutrients to be declared to the Codex Gui delines on Nutrition Labelling. The C ODEX  
guidelines do not foresee the mandatory declaration of added sugars, trans -fat and dietary fibre.  
1.295.   With regard to the proposed mandatory requirement to indicate the added sugars content 
on the label, and the propose d definition of "added sugars ", the EU would like to invite Mexico to 
provide clarification regarding the rationale for this mandatory requirement and for choosing this 
definition. With regard to the proposed mandatory requirement to indicate the trans-fat content on 
the label, please be informed that the EU does not impose such indication in the nutrition declaration. 
Instead, establishing a legal upper limit for the content of industrial trans-fat in food appears to be 
the most effective measure in terms of public health and consumer protection. Therefore, in the EU, 
Commission Regulation (EU) 2019/649 lays down maximum limits for the content of trans -fat in 
food. The content of trans -fat, other than trans-fat naturally occurring in fat of animal origin, i n food 
intended for the final consumer and food intended for supply to retail, shall not exceed 2 grams per 
100 grams of fat.  
1.296.   The notified draft sets out a mandatory front -of-pack nutrition labelling system indicating 
that the products are in "Excess" of c ertain nutrients for prepacked foods whose content of energy, 
sugars, saturated fats, trans -fats and sodium exceed certain parameters. The EU recogni zes the 
 
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  importance of the close relationship between diet and health and acknowledges that providing the 
most important elements of the nutrition information front -of-pack can be a useful tool for 
consumers to assist them to see the essential nutrition information when purchasing foods. 
Notwithstanding this, the EU has taken a different approach to empower cons umers to make 
informed choices when adopting Regulation (EU) No 1169/2011 on the provision of food information 
to consumers, which came fully into application at the end of 2016. This Regulation imposes an 
obligation to provide nutrition information. Howev er, its placing on the front -of-pack is not 
prescribed. In order not to confuse consumers, Regulation (EU) No 1169/2011 clarifies which 
particulars of the nutrition declaration may be repeated on the front -of-pack (on a voluntary basis), 
either the energy value alone or the energy value together with the amounts of fat, saturates, sugars 
and the sodium content expressed as salt.  
1.297.   Regulation (EU) No 1169/2011 notes the recent developments through the use of graphical 
forms or symbols and acknowledges that suc h additional forms of expression and presentation may 
help consumers to better understand the nutrition declaration and allows for different forms to be 
developed on the basis of criteria established in the Regulation itself. Among these criteria are the 
requirements that the additional forms are based on sound and scientifically valid consumer research 
and do not mislead the consumer; that they aim to facilitate consumer understanding of the 
contribution or importance of the food to the energy and nutrient  content of a diet; that they are 
supported by scientifically valid evidence of understanding of such forms of expression or 
presentation by the average consumer; and that they are objective and non -discriminatory.  
1.298.   The EU considers that individual warning s such as "Excess calories", "Excess sugars ", 
"Excess saturated fats ", "Excess trans fats " and "Excess sodium " do not reflect the objective of front -
of-pack nutrition labelling as described in Section 5 of the Codex Guidelines on Nutrition Labelling, 
i.e. "to increase the consumer's understanding of the nutritional value of their food and to assist in 
interpreting the nutrient declaration ". Indeed, such individual warnings do not allow the consumer 
to understand the complete nutritional status of the food p roduct, but only to draw the consumer's 
attention to (a) single nutrient(s) in high quantity. In this context, the EU would like to recall 
Article  2.2 of the TBT Agreement, which states that: "Members shall ensure that technical regulations 
are not prepare d, adopted or applied with a view to or with the effect of creating unnecessary 
obstacles to international trade. For this purpose, technical regulations shall not be more trade 
restrictive than necessary to fulfil a legitimate objective, taking account of  the risks non -fulfilment 
would create ". 
1.299.   The EU would also like to recall Article 2.4 of the TBT Agreement which states that, "where 
technical regulations are required and relevant international standards exist or their completion is 
imminent, Members shal l use them, or the relevant parts of them, as a basis for their technical 
regulations". While it is the EU's understanding that the proposed measure would apply without 
difference to domestic and foreign producers, the impact will be particularly strong fo r foreign 
operators, which would have to adjust their production and labelling practices to comply with the 
draft resolution. At the 44th session of the Codex Committee on Food Labelling (CCFL44) of October 
2017, the Committee agreed to start new work to d evelop guidelines on the use of front -of-pack 
nutrition labelling. Work is ongoing  under the leadership of Costa Rica and New Zealand. The EU 
considers that it would be more appropriate for Mexico to await the outcome of further discussions 
in Codex before  considering the mandatory front -of-pack nutrition labelling model proposed in the 
notified draft.  
1.300.   The delegation of Switzerland  provided the following statement. Switzerland would like to 
reiterate its concerns regarding the amendment of the Mexican Offic ial Standard NOM -051-
SCFI/SSA1 -2010 "General specifications for the labelling of pre -packaged food and non -alcoholic 
beverages - Commercial and health information ", which was notified to the WTO TBT Committee on 
14 October 2019 and published in the Officia l Journal on 27 March 2020 as a final measure. The on -
going  coronavirus pandemic has further amplified our concerns. The coronavirus pandemic is putting 
integrated supply chains under considerable strain and causing significant challenges to businesses 
around the world. Changes to the national labelling requirement will only add to these challenges at 
a time when producers, importers and retailers are trying to ensure the uninterrupted supply of food 
and beverages to the Mexican market. It is therefore with  some urgency that we call on the Mexican 
authorities to delay the entry into force of the amendment of the Mexican Official Standard NOM -
051-SCFI/SSA1 -2010 to a later date.  G/TBT/M/81  
 
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  1.301.   Switzerland welcomes the detailed written responses by the Mexican authorities, wh ich were 
circulated in document "Respuestas PROY NOM 051 SCFI SSA1 2010 " on 1 April. There remain, 
however, some aspects where further clarifications are welcomed . Despite Mexico's efforts to explain 
that the amendment is in line with international guideli nes, we do not see how this can be the case 
since the C odex Guidelines on Nutrition Labelling do not foresee the use of warning labels as 
proposed by the amendment. We also note that no explanation is given regarding the second part 
of our question concern ing the motivation behind choosing a label with warnings such as "exceso 
en". As mentioned previously, consumers may come to believe that these foods should be avoided 
altogether, while they can be part of a balanced diet. It remains unclear whether the Me xican 
authorities have considered alternative, less  trade -restrictive measures. We therefore would like to 
reiterate our call to consider a voluntary approach that would bring on board the food and beverage 
industry. In the case of Switzerland this has pro ven to be a workable approach that has yielded 
positive outcomes.  
1.302.   Switzerland looks forward to engage further with the Mexican authorities and to deepen its 
bilateral cooperation in line with Article 10 (2) of the EFTA -Mexico Free Trade Agreement, which ca lls 
on the Parties to "strengthen their co -operation in the field of technical regulations " and "to facilitate 
the mutual exchange of information and assistance in this field and cooperate  during the 
development of standards, technical regulations or conformity assessment procedures. " In light of 
these comments, Switzerland encourages Mexico to review  the amendment of the Mexican Official 
Standard NOM -051-SCFI/SSA1 -2010 and to delay its entry into force to a later date in order to 
ensure an adequate supply of food and beverages to the Mexican market during the COVID -19 
pandemic.  
1.303.   The delegation of El Sa lvador  provided the following statement. El Salvador wishes to  
express its concern regarding Mexico's notification in document G/TBT/N/MEX/178/Add.9  of 
14 October  2019, which concerns an amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specificatio ns for the labelling of pre -packaged food and non -alcoholic beverages - 
Commercial and health information, published on 5 April 2010 . The amendment was subject to public 
consultation for 60 calendar days until 10 December 2019. El Salvador submitted a numb er of 
comments  on the amendment to the above -mentioned Standard, pointing out that while one of the 
aims of the amendment, according to Mexico, is to prevent and control obesity , there is, to date, 
and in El Salvador's view, no technical and scientific pro of of a direct link between the establishment 
of a warning label and a reduction in, or the control of, this disease. It is therefore questionable 
whether these measures would achieve any legitimate health -related objective . In addition to this, 
there are other factors, such as sedentariness, which play a more prominent role in obesity . The 
warning label is not a comprehensive solution to the problem and would have serious implications 
for trade . 
1.304.   El Salvador recognizes that another of Mexico's objectives is  to provide consumers with 
accurate information so that they can make good nutritional decisions with a view to preventing 
non-communicable diseases  such as obesity . Nevertheless , El Salvador considers that the use of 
front-of-pack labelling will not neces sarily help consumers to make good choices regarding what 
they consume . On the contrary , such choices are linked, in many cases, to consumers' socio -
economic standing and level of education . We therefore reiterate that warning labels lack a  sound 
scientifi c basis  for meeting the legitimate objective pursued, and diverge from applicable 
international standards in this area , in particular the Codex Alimentarius . El Salvador is also 
concerned to see that the front -of-pack labelling system proposed by Mexico is  based largely on the 
Pan American Health Organization's Nutrient Profile Model , which lacks the appropriate scientific 
basis to be used as a suitable document for setting maximum nutrient parameters for the specific 
diet of the Mexican population  and does not reflect international standards and guidelines, thus not 
ensuring the promotion of more healthy diets . Furthermore, Mexico's proposed front -of-pack 
labelling system covers only processed products, and excludes non -processed products , which are 
produced domestically, thereby implying clear discrimination . 
1.305.   El Salvador recognizes the efforts made by the Government of the Republic of Mexico to 
gather together all the comments on the above -mentioned Standard and to respond to them in the 
document notified in G/TBT/N/MEX/178/Add.10  of 16 March  2020. However, given the length of that 
document, it is quite difficult to identify the individual responses to each of the comments made . 
El Salvador therefore requests that, in accordance with Article 2.9.4 of the TBT Agreement , Mexico 
provide it with the specific responses to the comments made, so that it has greater clarity and can 
convey the responses to the national production sector . For this and other reasons , El Salvador G/TBT/M/81  
 
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  considers it appropriate to discus s this Mexican Standard at the next TBT Committee meeting and 
believes that such discussion should take into account the scientific rationale provided by relevant 
international bodies and forums . 
1.306.   The delegation of Guatemala  provided the following statement. We thank the United States,  
Costa Rica, the European Union , Switzerland  and El Salvador for including this item on the agenda . 
We recognise Mexico's legitimate objective to protect the health of its population and to prov ide 
information to consumers . Nevertheless , we reiterate that, pursuant to Article 2.2 of the 
TBT Agreement, measures must not be more trade -restrictive than necessary to fulfil that objective . 
Guatemala submitted comments in December 2019 during the publi c consultation period . Having 
reviewed the new version of Mexican Official Standard NOM-051-SCFI/SSA1 -2010, as notified, 
Guatemala wishes to make a number of comments, including the following. The limits set for 
nutrients on labels reflect  the thresholds e stablished by the WHO on the basis of the global daily diet 
of an individual, a parameter that was transferred proportionally to the specific product, when it is 
not a parameter established within the Codex Alimentarius framework. It should be taken into 
account that each food product brings different nutrients to a diet, i.e. a food product may contain 
one specific nutrient, but not another. The values established in the WHO criteria should not 
therefore define a characteristic of a specific food or bevera ge. 
1.307.   The new labelling regulations refer to when a product is an "imitation" . In Guatemala, we 
consider this measure to be inconsistent with the Codex Alimentarius, which establishes adequate 
provisions for ensuring that consumers are properly informed about the true nature of a product . 
Furthermore , we believe that establishing typographical characteristics for the denomination 
"imitation" constitutes an unnecessary restriction on international trade . Regarding the warning  
"Contains sweeteners,  avoid consumption by children", it is considered, from a toxicological 
viewpoint, that CODEX  STAN  192-1995 establishes an acceptable daily intake based on the scientific 
assessment of the  Joint FAO/WHO Expert Committee on Food Additives  (JECFA), and it is  therefore 
deemed that this warning does not have the scientific backing  to prove that the product does indeed 
harm children over the age of three . 
1.308.   The restriction on the use of children's characters limits the use and enjoyment of an 
intellectual or indus trial property right (e.g. mark, caricature, cartoon) and not only inhibits the 
intellectual development of creators, but also prevents any contribution to ensuring distinctive 
elements between products for consumers, as provided for in the WTO Agreement o n Trade -Related 
Aspects of Intellectual Property Rights (TRIPS) . We also wish to express our concern regarding the 
discontinuation of the use of adhesive labels in order to ensure compliance  with the requirements 
set out in the Mexican Official Standard fo llowing the transition period . Paragraph 8.2.1 of Codex 
Standard CXS 1 -1985: General Standard for the Labelling of Prepackaged Foods, states that "If the 
language on the original label is not acceptable, to the consumer for whom it is intended, a 
supplemen tary label containing the mandatory information in the required language may be used 
instead of relabelling ", while paragraph  8.2.2 states that "In the case of either relabelling or a 
supplementary label the mandatory information provided shall […] fully a nd accurately reflect that 
in the original label ". With the provision established in the current Standard, Mexico is departing 
from the international reference standard . 
1.309.   It is important to note, within the Codex Alimentarius  framework , that at the 44th Session of 
the Codex Committee on Food Labelling  in October 2017, the Committee agreed to begin new work 
to develop a guide to the use of front -of-pack nutrition labelling. This work is coordinated by Costa 
Rica and New Zealand . For small economies like ours,  new regulations containing labelling 
requirements generate concern because they create a lack of harmonization among such provisions 
worldwide , making it difficult for small and medium -sized producers to gain access to the 
international market  because of different labelling requirements and restrictions . We request Mexico 
to cancel the  discontinuation of the use of adhesive labels, as this measure  is more trade -restrictive 
than necessary . We reiterate that consideration must be given to the provisions of t he Codex 
Alimentarius  and to respect for the evidence provided by the relevant scientific bodies . The aim of 
the Codex Alimentarius is to ensure international harmonization and the elimination of trade barriers . 
1.310.   The delegation of Canada  provided the following statement. Canada thanks Mexico for its 
1 April 2020 addendum to notification G/TBT/N/MEX/178  informing Members that the amendment 
to Mexican Official Standard NOM -051 SCFI/SSA1 -2010 has been published. Canada appreciates 
that Mexico has kept Members informe d through each step of its process to amend NOM -051. Mexico 
has demonstrated that it takes its transparency obligations under the TBT Agreement seriously. G/TBT/M/81  
 
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  Canada also notes that Mexico has taken a phased approach to the application of the changes to 
NOM-051. The first stage of enforcement is from 1 October 2020 to 30 September 2023. A 1 October 
2020 enforcement date provides producers six months to comply with the amended measure. While 
this six -month coming -into-force period is recognized and applied as th e minimum reasonable 
interval between the final publication of a measure and its entry into force, it will be very difficult 
for Canadian producers to fully comply with the new labelling requirements by October 2020 due to 
the significant nature of the cha nges. This difficulty is further exacerbated by the current situation 
as a result of COVID -19. Consequently, Canada respectfully asks Mexico to consider delaying the 
coming into force period for Stage 1 of the amendments to NOM -051 by at least 12 months to  
provide operators additional time to comply with the changes.  
1.311.   In response, the delegation of Mexico  provided the following statement. Mexico thanks the 
delegations of Canad a, Costa Rica, El Salvador, the United States , Guatemala, S witzerland  and the 
Europ ean Union for their comments, submitted through the TBT Committee's written procedure,  on 
the final amended version of Mexican Official Standard NOM-051-SCFI/SSA1 -2010: General 
specifications for the labelling of pre -packaged food and non -alcoholic beverag es - Commercial and 
health information  (hereinafter NOM -051),  published in the Mexican Official Journal ( Diario Oficial 
de la Federación ) on 27 March  2020 and notified to WTO Members on 1 April 2020 in document  
G/TBT/N/MEX/178/Add.11 . The amendments to NOM-051 seek to  provide Mexican consumers with 
clear, truthful and accurate information on critical nutrient content and commercial information via 
the labelling of pre-packaged food and non -alcoholic beverages , with a view to helping them make 
better informed decisions . The amendments to NOM-051, which are based on the Regulatory Impact 
Analysis presented before the National Commission on Regulatory Improvement, constitute one of 
the most important elements of the comprehensive strategy developed by the Government of Mex ico 
to address health problems related to non -communicable diseases such as obesity and excess weight 
gain. 
1.312.   At present , labels attached to pre-packaged food and non -alcoholic beverages marketed in 
Mexico must adhere to the Guideline Daily Amount -based  front-of-pack labelling system. This 
labelling system has not had the desired impact in terms of the Mexican population's understanding 
of information concerning critical nutrient content . The amendments to  NOM-051 therefore seek to 
ensure the  fulfilment of legitimate public health objectives and to prevent consumers from being 
misled . Details of the technical and scientific evidence that underpins NOM-051 can be found in 
Chapter 11 of the Standard (Bibliography), which lists the 157 bibliograp hical references used for 
the final version of this technical regulation . Given that no existing international standard covers the 
aspects that the amendment s to NOM-051 seek to address , the Government of Mexico has devised 
and adopted the measures that it  considers appropriate for ensuring the fulfilment of its legitimate 
objectives in light of current public health challenges . On the basis of the above, Chapter 10 of the 
amended version of NOM-051 ( Concordance with international standards ) states that the  Standard 
is not equivalent to the Codex Alimentarius standards cited therein . 
1.313.   Following an analysis of the international standards linked to the objectives of NOM-051, it 
was concluded that some of the concerns leading to the amendment of NOM-051 were not  addressed 
by international standards, particularly in respect of the following : imitation products; product 
names; sugar and allergen declarations in the list of ingredients ; the use of images , characters , 
drawings and other elements aimed at children in products containing excess critical nutrients ; the 
use of recommendations from professional associations that promote the consumption of products 
without  an analysis of the health characteristics thereof ; and the us e of nutritional and health 
properties  of products containing excess critical nutrients . Furthermore, and given that existing 
international standards do not address  matters pertaining to "substitute" or "imitation" products, 
and in view of the Government of Mexico's aim to provide consumers with clear, truthful and accurate  
information , it is considered appropriate to include wording that informs consumers when a 
component or ingredient normally used or naturally present in the end product has been substituted . 
1.314.   Transitional articles provide for a phased entry into force of NOM-051. Phase  1 relating to 
the front -of-pack labelling system (stamps and warnings ) will enter into force on 1 October 2020, 
more than six months after the publication of the measure in the Mexican Official Journal  (DOF). 
From 1 October  2020 to 31 March  2021,  the requirements of the front -of-pack labelling system may 
be met by using stickers or any other form of adhesive label that can be attached to the existing 
product label . The use of adhesive labels is a temporary measure to facilitate transition to the 
requirements of the newly amended NOM -051. However, by  1 April 2021, labelling must comply 
with all the established requirements . This means that the parties concerned have more than a year G/TBT/M/81  
 
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  from when the final version of NOM -051 was published in the DOF, to  fully comply with all of its 
provisions . Regarding the comments received during the public consultation process, which ran from 
12 October to  10 December  2019,  all the comments received, from both within Mexico and abroad, 
were examined and given equal co nsideration . As a result of that review , the relevant changes were 
made to the draft amendment to NOM-051. 
1.315.   In view of the fact that there is currently no international standard on nutritional profiles and 
consumption limits for a healthy diet, the nutritio nal profile set out in the amendment to  NOM-051 
is based on technical and scientific elements compiled by the Pan American Health Organization, and 
deemed appropriate for contributing to the strategy to address the public health challenges currently 
faced by the Mexican population and for informing consumers about excess critical nutrients 
commonly linked to excess weight gain and obesity . Paragraph  3.22 of the final version of the 
amendment to NOM-051 defines dietary fibre as carbohydrate polymers with ten or more monomeric 
units, which are not hydroly zed by endogenous enzymes in the small intestine . In this light , the 
specification regarding the monomeric units that carbohydrate polymers need in order to be 
considered as dietary fibre applies to the three categories listed in paragraphs  3.22(a), (b) and (c) 
of the final version of the amendment to NOM-051. 
1.316.   The inclusion of warnings concerning the use of sweeteners and caffeine  is considered 
necessary given that the products covered by NOM-051 may be consume d by vulnerable population 
groups, such as children . In the specific case of sweeteners, their inclusion was based on the 
technical and scientific evidence included in Chapter 11 (Bibliogra phy), which ranks Mexico as one 
of the countries with the highest r ates of excess weight gain and obesity in children in the world . 
Furthermore, it should be made clear that in the specific case of warnings concerning sweeteners, 
they are included not for toxicological purposes, but simply for informative reasons . Regardi ng 
caffeine , the technical and scientific information included in Chapter 11 (Bibliography) of the final 
version of the amendment to NOM-051 bases the inclusion of this additive on the effects that  it can 
have on children . As noted by several of the members of this Committee in their statements, there 
is currently no international reference standard that may be used as a basis for establishing front -
of-pack labelling. Discussions are, however, taking place within the Codex Alimentarius framework . 
Lastly, Mexico's position regarding the work currently under way in that forum was expressed at the 
45th Session of the Codex Committee on Food Labelling , held from 13 -17 May 2019 in Ottawa, 
Canad a. At that meeting, the delegation of Mexico expressed its suppo rt for work on the paper on 
"criteria for the definition of 'high in'  nutritional descriptors for fats, sugar and sodium ". 
1.3.24   Peru – Supreme Decree No. 015 -2019 -SA, which amends the Manual of Advertising 
Warnings approved by Supreme Decree No. 012 -2018 -SA (IM S ID 61860) 
1.317.   The delegation of Costa Rica  provided the following statement. Costa Rica wishes to reiterate 
its concern about the Peruvian regulations included in Supreme Decree No.  015-2019-SA, which 
amends the Manual of Advertising Warnings approved by Supr eme Decree No.  012-2018-SA. Under 
the proposed amendment to the Manual of Advertising Warnings, the use of stickers or adhesive 
labels to meet the Manual's labelling requirements for advertising warnings will no longer be 
permitted in Peru as of June  2020.  We would like to reiterate what our food industry has said about 
the negative repercussions that such provisions have on trade, as purchases of products not 
permanently labelled at origin have already decreased to ensure that there will be no stocks when 
the use of adhesive labels is banned.  It should be noted that the use of adhesive labels is widely 
recognized internationally, as such labels achieve the same public health protection and consumer 
information purposes achieved by permanent labels.  At the C ODEX level, for example, Articles 8.1.1 
and 8.2.1 of CODEX -STAN  1-1985,  General Standard for the Labelling of Prepackaged Foods, permit 
the use of supplementary or adhesive labels, as long as it is guaranteed that they will not become 
separated from the co ntainer, or in cases where the language on the original label is not acceptable 
to the consumer for whom it is intended . 
1.318.   Furthermore, we note that countries with labelling schemes requiring the use of high fat, 
sodium or sugar content warnings, similar to Peru's, have considered supplementary labelling using 
stickers, which not only provides the required level of protection, but also makes it easier for 
exporters to comply with non -harmonized international requirements.  Peruvian food products sent 
to the Co sta Rican market are able to comply with domestic labelling requirements through the use 
of supplementary adhesive labels, instead of having affix permanent labels in the country of origin, 
 
60 For previous statements follow the thread under IMS ID  618 (under dates raised and references) . G/TBT/M/81  
 
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  exclusively for the Costa Rican market. This undoubtedly fosters t rade and is proportionate to the 
level of protection sought. We therefore ask for reciprocity of treatment.  Moreover, other Peruvian 
instruments, such as Supreme Decree No.  007-98-SA adopting the regulations on sanitary 
surveillance and control of food and  beverages, permit the use of stickers to meet labelling 
requirements, given that this is an appropriate means for the fulfilment of the proposed legitimate 
objectives.  The fact that Peruvian legislation, in other instruments, permits the use of an adhesiv e 
or additional label no doubt shows that there are less trade -restrictive measures through which it is 
possible to fulfil the proposed legitimate objectives, in accordance with the obligations regarding 
technical barriers to trade established in the relev ant World Trade Organization Agreement and in 
the existing Agreement between our countries.  
1.319.   With regard to the commitments made by Peru under the Agreement on Technical Barriers 
to Trade, we note that the measure giving rise to this trade concern does not appear to have been 
notified. We therefore ask the Peruvian delegation to confirm whether the notification was made in 
accordance with the provisions of this Agreement. We are also of the view that, in light of the 
foregoing, the measure in question may in compatible with the obligations assumed by Peru under 
Articles  2.2, 2.4 and 2.9 of the TBT Agreement.  Lastly, Costa Rica would like to emphasize once 
again, as it has already done before this Committee, that in light of the current situation faced by 
the world as a result of COVID -19, international cooperation in all areas is crucial for tackling the 
crisis and laying the groundwork for a swift economic recovery post -pandemic, through the 
promotion of trade -facilitating measures, as opposed to measures  that might create technical 
barriers to trade and hinder economic recovery.  For all of the reasons above, we respectfully request 
that the Peruvian authorities amend the provisions of the Manual of Advertising Warnings to allow 
the use of adhesive labels with no time -limit. 
1.320.   The delegation of Brazil  provided the following statement. Brazil supports Peru's pursuit of 
higher health standards through technical regulations that help better inform consumers. However, 
Brazil would like to manifest its concerns re garding labelling requirements expressed in the Manual 
of Advertising Warnings approved by Supreme Decree No. 012 -2018-SA (G/TBT/N/PER/97/Add.1)  
and amended by Supreme Decree No 015 -2019-AS (unnotified). According to the current 
requirements, as of June 2020, stickers a nd adhesive labels will no longer be permitted for foods 
and beverages under the scope of said Manual. Foreign companies will then have to produce a 
specific label according to the requirements of the Peruvian legislation, which will unnecessarily 
impose g reater costs to producers and consumers. The use of adhesive labels is common practice 
at the international level, as it does not affect the provision of reliable information to consumers. In 
fact, Codex standard CODEX -STAN 1 -1985 for pre -packaged goods, A rticles 8.1.1 and 8.2.1, 
explicitly allow for the possibility of using additional or adhesive labels, as long as they are attached 
to the packaging and if the language of the original label is not necessarily that of the consumer for 
whom it is intended.  
1.321.   Since such regulation was first brought to our attention, Brazil sought to solve our concerns 
bilaterally. We acknowledge Peruvian concerns with deceptive practices that could be related to 
adhesive labelling. Yet, advances in labelling technologies allow f or safe affixation of labels. Brazil 
would be willing to share with Peru its regulatory experience related to such labelling requirements. 
In early 2020, our private sector warned that global companies that export to Peru were already 
facing the negative i mpacts as of a consequence of these burdensome and unnecessary 
requirements. In our bilateral meetings, Peru failed to provide a time frame  for possible amendments 
to the regulation, which creates greater uncertainty for our private sector to take on inform ed market 
decisions. Brazil would like to respectfully ask Peru to align its labelling requirements with current 
international standards established under the Codex and withdraw the prohibition of adhesive 
labelling for products under the scope of the Manu al of Advertising Warnings. We also urge Peru to 
notify any further update to this regulation, following its obligations under Articles 2.1, 2.4 and 2.9 
of the TBT Agreement.  
1.322.   The delegation of the United States  provided the following statement. The United States 
supports the interventions of Costa Rica and Brazil. Can Peru provide an update on when it will 
modify the provisions established in the Manual, so as to allow compliance with labelling 
requirements through an extended use of stickers? Peru confirme d it would continue to allow stickers 
for front -of-pack food label ling at the February 2020 WTO TBT Committee, but we have not seen an 
updated TBT notification or addendum confirming stickers can continue to be used.  G/TBT/M/81  
 
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  1.323.   The delegation of Ecuador  provided the following statement. Ecuador shares and expresses 
concern about Peru's intention to no longer permit, as of 15  June 2020, the use of stickers on 
packaged products for the advertising warnings prescribed by the Manual of Advertising Warnings. 
This ban on st ickers is of concern to the Ecuadorian industry, as it would significantly affect trade 
with the Republic of Peru.  My country's industry has submitted the following comments on this 
measure . (i) Factories ship a small volume of between 0.02 % and 8.8 % of their total production for 
the Latin American region to Peru. As of 15  June, these enterprises will not be able to bear the cost 
of producing special packaging, which already includes warnings, for Peru, due to the small volume 
of production. (ii) Other coun tries in the region permit the use of adhesive labels under their labelling 
requirements for foods and pre -packaged products. (iii) In Peru, the use of stickers to indicate the 
name of the product, the business name and the address of the importer is alrea dy permitted under 
Supreme Decree No.  007-98-SA adopting the regulations on sanitary surveillance and control of 
food and beverages. (iv) In Peru, enterprises are already obliged to ensure that stickers are legible 
at the point of sale, under the supervisi on of INDECOPI, in accordance with Article 10.2 of the 
Consumer Protection Code (Law No.  29571).  Ecuador therefore proposes the following wording in 
paragraph 8.3 of the Manual of Advertising Warnings approved by Supreme Decree 
No. 012-2018-SA: "All food a nd beverages must contain advertising warnings, where appropriate. 
The use of indelible and permanent stickers with advertising warnings is permitted as from the entry 
into force of this Manual."  The Ecuadorian food industry considers this proposal appropr iate because:  
it does not distort the purpose of Law No.  300213, as the warning requirement is upheld;  the current 
Peruvian regulations already permit the use of stickers; and  permitting the use of labels for warnings 
is the least trade -restrictive measure  and allows Peru to fulfil its desired objective.  
1.324.   The delegation of Colombia  provided the following statement. Colombia welcomes and 
appreciates the Peruvian Government's desire to adopt a public policy measure that seeks to 
effectively promote and protect  the right to public health, human growth and sound development, 
through educational activities, the strengthening and promotion of physical activity, and the 
monitoring of advertising, information and other practices related to food and non -alcoholic 
beverages aimed at children and adolescents, in order to reduce and eliminate diseases linked to 
excess weight or obesity and chronic non -communicable diseases.  However, Colombia wishes to 
reiterate its concern regarding the provisions of Article  2 of Supreme  Decree No.  015-2019-SA, 
which amends the Manual of Advertising Warnings approved by Supreme Decree No.  012-2018-SA, 
as it considers that they are more restrictive than necessary and may become an unnecessary 
obstacle to trade, violating Article 2.2 of the Agreement on Technical  Barriers to Trade (TBT 
Agreement), which states: "Members shall ensure that technical regulations are not prepared, 
adopted or applied with a view to or with the effect of creating unnecessary obstacles to international 
trade. For this purpose, technical regulations shall not be more trade -restrictive than necessary to 
fulfil a legitimate objective, taking account of the risks non -fulfilment would create."  
1.325.   It should be noted that Article 2 of Supreme Decree No.  015-2019-SA stipulate s that the 
use of stickers with advertising warnings is to be permitted for one year, a period that will expire in 
June 2020. Therefore, as of June  2020, processed foods will no longer be able to enter the Peruvian 
market by using stickers to comply with l abelling requirements. Colombia considers that allowing 
the use of stickers does not distort the purpose of the Healthy Food Law No.  30021, its implementing 
regulations (Supreme Decree No.  017-2017-SA) or the Manual of Advertising Warnings 
(Supreme  Decree No. 012-2018-SA), as the warnings, whether included on stickers or printed 
directly on the packaging of the products, will continue to be clear, legible, prominent and 
comprehensible, as required by the regulations.  A technical measure on labelling  that is  so specific 
to a particular country, which must be implemented at the country of origin and does not allow the 
use of stickers with the required information, is a technical barrier to trade, and constitutes a major 
barrier to access for producers in count ries such as Colombia, especially for enterprises whose 
current and projected sales volumes in Peru cannot justify the expense of making a "factory" label 
designed specifically to comply with the regulation. Peru engages in international trade with many 
trading partners and enterprises with different economies of scale; the enterprises whose economies 
of scale and volumes of trade do not warrant the increased expense of developing special packaging 
for trade with a country that imposes an unnecessary barrie r of this nature will be most affected.  
1.326.   Furthermore, imposing this type of unnecessary trade -restrictive measure runs counter to 
international labelling practice and the Codex Alimentarius, such as Article 8 on Presentation of 
Mandatory Information of CODE X-STAN  1-1985 (Revised in 2018), General Standard for the 
Labelling of Prepackaged Foods. It also runs counters to Article 2.4 of the TBT Agreement, which 
refers to the preparation, adoption and application of technical regulations and reads: "Where G/TBT/M/81  
 
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  techni cal regulations are required and relevant international standards exist or their completion is 
imminent, Members shall use them, or the relevant parts of them, as a basis for their technical 
regulations except when such international standards or relevant parts would be an ineffective or 
inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of 
fundamental climatic or geographical factors or fundamental technological problems."  In light of the 
above, Colombia once again requests that Peru allow the use of stickers with warning icons and 
messages on food packaging to avoid creating an unnecessary technical barrier to trade such as the 
one envisaged in the Supreme Decree.  
1.327.   The delegation of Guatemala  provided the following statement. Guatemala wishes to thank  
Costa Rica, Brazil and the United States for including this item on the agenda.  As of June  2020, 
processed foods with advertising warnings will no longer be able to enter the Peruvian market with  
adhesive labels.  This means that food and beverages must be labelled in accordance with the 
requirements in the country of origin, increasing costs and thus preventing small and medium -sized 
enterprises from exporting to the market, as it would be difficu lt for them to provide different labels 
for each market. Adhesive labels offer a solution and enable compliance with the necessary 
information requirements.  Article  8.2 of CODEX CXS  1-1985, General Standard for the Labelling of 
Prepackaged Foods, states th at a supplementary label containing the mandatory information in the 
required language may be used and shall fully and accurately reflect the information in the original 
label.  
1.328.   Guatemala reiterates its concern over the growing lack of harmonization of fron t package 
labelling, at the global level, and the associated nutrient profiles. For small and medium -sized 
enterprises trying to internationalize their operations, these are complex measures that limit trade.  
While we recognize Peru's legitimate objective of protecting human health and providing consumer 
information, we consider the measure to be more restrictive than necessary . We reiterate that the 
provisions contained in the CODEX should be taken into consideration, such as the General Standard 
for the L abelling of Prepackaged Foods, which allows the use of supplementary labels, as other 
trading partners have done.  We request that adhesive labelling be permitted to prevent the creation 
of unnecessary barriers to trade.  
1.329.   The delegation of the European Union  provided the following statement. The E U would like 
to support the other Members in raising the Peru measure on labelling requirements for processed 
foods. The proposed measure is causing concerns also for the European Union and it would cause 
an unnecess ary obstacle to trade for EU importers. The EU would like to invite Peru to allow stickers 
for the purposes of compliance with the label ling requirements for the products concerned. We are 
committed to working with Peru on this issue and we are confident t hat a solution can be found.  
1.330.   In response, the delegation of Peru provided the following statement. The delegation of Peru 
would like to thank the delegations of Costa Rica, Brazil, the United States, Ecuador, Colombia, 
Guatemala and the European Union for raising this trade concern once again.  As mentioned at the 
meeting of the previous Committee, Peru wishes to reiterate that it is committed to fulfilling the 
legitimate objective of protecting the public health of its citizens, particularly the health of i ts most 
vulnerable groups, such as children and adolescents, in accordance with its international trade 
commitments in this domain.  Peru seeks to ensure that the information contained in the Manual of 
Advertising Warnings reaches consumers clearly and effe ctively, so that they can make informed 
choices. Despite the current health emergency that has been demanding our attention, Peru, taking 
into account the trade concerns expressed by some partners, is analysing alternatives that would be 
suitable for fulfi lling the objective of information being pursued.  Lastly, we would like to emphasize 
once again that Peru wishes to honour its WTO commitments and therefore reaffirms its commitment 
to not preparing, adopting or applying technical regulations that may crea te unnecessary barriers to 
international trade, as established in the Agreement on Technical Barriers to Trade.  
1.3.25   Kingdom of Saudi Arabia – Electrical Clothes Washing Machines – Energy and 
Water performance Requirements and labelling (IMS ID 61961) 
1.331.   The delega tion of the Republic of Korea  provided the following statement. Korea would like 
to make some comments regarding this regulation as follow s. Saudi Arabia has publicly issued a 
notice  using a "pop-up" form in the SASO  homepage on 14 Janua ry 2020. Korea has delivered our 
concerns on this regulation through a bilateral meeting between Korea and Saudi Arabia and in 
 
61 For previous statements follow the thread under IMS ID  619 (under  dates raised and references) . G/TBT/M/81  
 
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  discussions on STCs during the 1st WTO TBT Committee meeting  in 2020. In this regard, Saudi 
Arabia responded  that "the notification is easing the required conditions a little bit" through a letter 
on the bilateral meeting at the 1st WTO TBT Committee meeting on 27 February 2020, and we 
understand that Saudi Arabia has expressed its position that this issue is no t subject to a WTO TBT 
notification. Against this backdrop, Korea would like to outline the hardship this notice is causing for 
washing machine manufacturers as well as the rationale for requiring a WTO TBT notification.  
1.332.   First of all, the minimum water te mperature condition stipulated in the notice is used as a 
basis for measuring energy efficiency as well as washing performance. In general, washing at high 
temperatures is advantageous in terms of washing performance provided the maximum temperature 
is not  exceeded. However, the energy efficiency rating is calculated by measuring the amount of 
energy used at the same time. Because both washing performance and energy efficiency are 
measured in one test, manufacturers have to design separately manufacturer's unique optimized 
washing programmes based on International Standards (IEC 60456) to achieve the best result for 
both tests. For this reason, many global manufacturers try to test washing machines by optimizing 
other conditions such as water usage, washing time, etc. at lower water temperature rather than 
raising the water temperature during the washing cycle in order to achieve the best results for both 
tests. In these circumstances, the notice effectively constrains the manufacturer's autonomous 
washing pr ogramme design. This may result in forcing a significant change to the energy efficiency 
rating of existing products. Therefore, the notice is not "easing " the required conditions, as Saudi 
Arabia has claimed, but instead makes them "severely stricter ". In addition, not only the 
International Standard (EN, IEC 60456) cited in this regulation, but also on a global scale no country 
restricts the minimum temperature while stipulating a maximum temperature under the conditions 
for the washing test. For this rea son, in accordance with Article 2.9 of the WTO TBT Agreement, 
Korea request s to notify the changes to the WTO TBT Committee and proceed in accordance with 
the notification procedure.  
1.333.   Korea would like to request if by any chance the relevant authorities can  provide a 
reasonable background of its implementation and scientific grounds in relation to the minimum water 
temperature conditions. In addition, as the notice requires that manufactures include additional data 
on the instruction sheet or user manual, th is change is also subject to the WTO TBT Notification in 
accordance with Article 2.9 of the WTO TBT Agreement. The Korea respects the efforts of the Saudi 
Arabian government to provide information and to protect the environment, though Korea would 
like to ask Saudi Arabia to review our request positively so that the manufactures can comply with 
this regulation.  
1.334.   The delegation of Mexico  provided the following statement. The delegation of Mexico refers 
to the communication from the Saudi Standards, Metrology and Quality Organization (SASO), 
circulated on 14 January 2020, giving notification of significant technical amendments to technical 
regulation SASO  2885/2018 relating to energy efficiency of washing machines. Although the 
Government of Saudi Arabia circul ated this communication, the amendments have not been notified 
to the Members of the WTO's Committee on Technical Barriers to Trade (TBT Committee).  
1.335.   Mexico wishes to express the following concerns . Temperature -related changes in the drum : 
the amendments re fer to the temperature measuring requirement for washing machines that do not 
have a water heater feature.  In general terms, the requirement is for top -loading washing machines 
without a water heater feature to be assessed at higher temperatures (60°C - 40°C). The previous 
requirement for temperature measurement was between 60°C and 15°C.  By amending the 
temperature measurement requirement in this way, the Kingdom of  Saudi  Arabia would appear to 
be indirectly limiting its imports of washing machines by allo wing only front -loading washing 
machines to meet these new criteria. Without a scientific and technical basis for these changes, this 
measure would appear to constitute an unjustified barrier to trade under Article 2.2 of the WTO 
Agreement on Technical Bar riers to Trade (TBT  Agreement).  
1.336.   Coexistence of energy efficiency classes : countries have allowed technologies to coexist in 
their technical regulations on these products in order to address the differences between existing 
systems. However, with this propo sed change, the Kingdom of Saudi Arabia would seem to be 
preventing this coexistence that was previously permitted under its technical regulations. It is 
important to know whether the Kingdom of Saudi Arabia has a specific concern that justifies the ban 
on the coexistence of different systems or whether this change is due to a problem that arose during 
the regulatory regime that allowed for the coexistence of technologies.  Use of international 
standards : in line with Article 2.4 of the TBT Agreement, the ba sis on international standards of the G/TBT/M/81  
 
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  proposed amendments or reasons for choosing to deviate from the relevant international standards 
must be known.  Principle of transparency : the content of the measure in question makes it 
compatible with the TBT Agreeme nt's definition of "technical regulation" and it must therefore 
comply with Article 2.9 of that instrument. However, no notifications have been identified relating 
to these latest amendments to technical regulation SASO  2885/2018.  Entry into force : Mexican  
industry informed us that the proposed amendment entered into force the day immediately after its 
publication. Should this be the case and considering that the measure does not constitute an 
emergency technical regulation, the measure could violate Articl e 2.12 of the TBT Agreement and 
Article 5.2 of the Ministerial Declaration adopted by WTO Members on 20 November 2001, regarding 
the reasonable interval for the entry into force of technical regulations.  
1.337.   The delegation of Mexico therefore submits the follo wing requests to the delegation of the 
Kingdom of Saudi Arabia: (i) s hare the technical and scientific rationale behind the amendments 
made to technical regulation SASO  2885/2018 on washing machines and energy efficiency. In the 
absence of this information , it is requested that the amendments be reconsidered, given that this 
measure would constitute an unjustified barrier to trade of the products covered ; (ii) i ndicate the 
alignment of this measure with the relevant international standards ; and (iii) n otify the measure in 
accordance with the transparency obligations contained in the TBT Agreement, and provide for a 
reasonable interval for its entry into force.  The delegation of Mexico thanks the delegation of the 
Kingdom of Saudi Arabia for giving its consideration to this statement and the requests therein.  
1.338.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement. 
Saudi Arabia thanks Republic of Korea and Mexico for raising this concern regarding SASO2885/2018 
"Electr ical Clothes Washing Machines – Energy and Water performance Requirements and labelling ". 
Saudi Arabia always committed to transparency as one of the main principles of WTO/TBT 
Agreement, which is clearly shown through numbers of notification that have bee n raised via our 
national TBT Enquiry Point. SASO would give information about SASO 2885/2018 – as requested in 
the above concerns  – especially regarding the temperature condition, as per in clause A.2, the testing 
conditions at full load is 60°C and  for half load is both 60°C and 40°C. However, the notification 
which has been published recently is relaxing this condition that applied for washing machines 
without heaters. Please see the table below which illustrates how to calculate the required 
temperature s. 
 Unit Cotton 40 ℃ ½ Cotton 60 ℃ ½ Cotton 60 ℃ 
Cold water consumption during man 
wash L 30.00  10.00  10.00  
Hot water consumption during man wash  L 30.00  50.00  50.00  
Supply cold water inlet temperature  ℃ 15.0 15.0 15.0 
Supply hot water inlet temperature  ℃ 60.0 60.0 60.0 
Water temperature calculated  ℃ 37.50  52.50  52.50  
Minimum allowable temperature  ℃ 25 45 45 
 
1.3.26   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 Telecommunicat ions, 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 27462) 
1.339.   The delegation of the European Union  provided the following statement. The European Union 
appreciates the clarifications and explanations given by India at previous meetings. We note that 
mandatory testing and certification of telecom equipment entered into force on 1 October 2019 for 
a limi ted range of products and also a limited range of tests. We also note that a one -year exemption 
from submission of test reports for specific parameters has been granted. Could India provide 
 
62 For previous statements follow the thread under IMS ID  274 (under dates raised and references) . G/TBT/M/81  
 
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  additional information on the next steps? India had published seve ral notifications that specify 
products for which in -country testing and certification will be made mandatory. The European Union 
stresses 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 the final requirements, including any 
applicable standards, specifications, testing methods and procedures. On the recognition of test 
results carried out outside India, the European Union would like to reiterate its concer ns that 
mandatory in -country testing means duplication of testing/certification processes on products. Other 
WTO Members accept products through mechanisms such as the declaration of conformity or ILAC -
accredited labs, as has India up to now. These mechani sms are less trade -restrictive means of 
achieving India's legitimate objectives of both safety and security , objectives which are shared by 
the EU. We would note that all equipment tested in the EU meets the highest standards in terms of 
safety and electro -magnetic  radiation according to the legal framework in place in the EU.  
1.340.   While we appreciate the previous announcement by India that it would continue to recogni ze 
foreign ILAC -accredited laboratory results, which was only until end of March 2020 , we woul d like 
to know the current status of recognition. We want that the recognition continues for products 
accredited by ILAC -certified laboratories. In any case, we want to stress the importance of a 
permanent recognition. Furthermore, the timeline of extensio n of testing and certification process 
for telecom equipment is unclear. We would like to know about the current status. Moreover, we 
have also learnt that India is soon going to introduce security testing for the equipment as well. We 
would like to know a bout the timeline of security testing and about any evaluation done about its 
possible impact on the supply chain.  
1.341.   The delegation of Canada  provided the following statement. Canada notes that, as per 
Telecommunications Engineering Centre Procedure no. TEC/ 10/2018 -TC Pt. dated 5  July 2019, ILAC -
accredited laboratory results were to be accepted up to 31 March 2020. Canada kindly requests that 
India indicate the current status of procedure no. TEC/10/2018 -TC Pt. Canada continues to seek the 
replacement of in -country testing requirements, under the "Mandatory Testing and Certification of 
Telecom Equipment " procedures, with the acceptance of appropriately accredited foreign test 
results.  
1.342.   In response, the delegation of India provided the following statement. India  would like to 
thank the European Union and Canada for their continued interest in this measure. India had 
provided detailed response to various queries raised by the Members on this issue during previous 
TBT Committee meetings and hence would not repeat t he same here. However, India would like to 
provide certain additional information to the Members for further clarity. Taking into consideration 
the concerns of the industry, MTCTE scheme is being implemented in a phased manner. Certification 
for the produc ts covered under Phase -I was made mandatory from 1 October 2019 (date of entry 
into force for MTCTE Phase -I). Proposal for launch of Phase -II of MTCTE is under consideration. It is 
reiterated that adequate time would be given before certification for produ cts covered under MTCTE 
Phase -II becomes mandatory (date of entry into force for MTCTE Phase -II). Test results from ILAC -
accredited labs were acceptable up  to 31 March 2020. Considering the fact that sufficient in -country 
testing infrastructure is now avai lable in respect of Equipment Safety and EMI/EMC related test 
parameters, the proposal for extension of acceptance of test results from ILAC -accredited labs 
beyond 31 March 2020 is under consideration only in respect of technical test parameters. 
Departmen t of Telecommunications (DoT)/TEC has an MRA scheme for mutual recognition of labs. 
To avoid duplication of testing as well as to facilitate trade, DoT/TEC would be willing to enter into 
MRA agreement with countries for mutual recognition of labs. The peri od of exemption from 
submission of test reports for specific parameters had been modified from one year to two years vi a 
Notification dated 5 July 2019 for Revision of MTCTE Procedure. For any other additional clarity 
required by the interested Members, In dia is ready to discuss such issues bilaterally.  
1.3.27   Russian Federation – Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011) , G/TBT/N/RUS/2  (IMS ID 33263) 
1.343.   The delegation of the European Union  provided the following statement. In 2012, the Russian 
Federation n otified a draft technical regulation on alcohol products safety. The EU submitted detailed 
comments to Russia and has since asked for updates on the status of the measure and whether the 
EU's comments had been taken into consideration. Despite these reques ts, Russia did not inform us 
of any developments on the measure, until it officially announced in December 2018 that a new 
 
63 For previous statements follow the thread under IMS ID  332 (under dates raised and references) . G/TBT/M/81  
 
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  version, in a form of a technical regulation of the Eurasian Economic Union, of the measure had been 
adopted. In light of transparenc y and considering the trade implications of this regulation, we would 
like to ask Russia to notify the revised text to the TBT Committee, in line with the TBT Agreement 
and relevant TBT Committee decisions and recommendations.64 The technical regulation also 
contains provisions covered by the Agreement on trade -related aspects of intellectual property 
rights. The EU would like to invite Russia to notify the regulation t o the Council for TRIPS, in 
accordance with Article 63.2 of t he TRIPS so that the discussion can take place there, as some of 
these provisions, in particular impacting geographical indications, raise serious concerns for the EU.  
1.344.   The European Union would like to express the following concerns with the new version of 
the measure. Physical and chemical requirements laid down in the regulation in some cases contain 
more stringent limits than those set in the recommendations of the OIV, of which Russia is Member. 
The application of these diverging requirements would repre sent an obstacle for the importation of 
these products. The EU is concerned by the mandatory labelling requirements set out in the 
regulation, which are not in line with international practice, by requiring for example, information 
such as date markings an d storage conditions The EU would like to ask Russia to refer to CODEX 
standards as regards the indication of date markings and storage conditions, which are strictly linked 
to each other. Could Russia confirm that the use of stickers is allowed, according  to CODEX STAN 1 -
1985?  
1.345.   Finally, alcoholic beverages must prove conformity with the rule set out in the regulation in 
order to be marketed in the EAEU territory. The conformity assessment is conducted by a state 
entity and covers a wide range of requirement s such as documentation and laboratory analysis, 
which represents a disproportionate burden and cost for producers. Could you please confirm that 
the conformity procedure will apply to imported products and that EU accompanying documents will 
be considered  as sufficient to establish the compliance of EU products with the notified technical 
regulation? Moreover, it appears that Russia has adopted a measure "Federal Law Nº 468 of 
27.12.2019 on wine making and wine growing in the Russian Federation" . This meas ure has not 
been notified to the WTO.  
1.346.   This Federal law contains several provisions that amount to obstacles for the importation of 
wine and wine -based products into the Russian Federation territory (i.e. prohibition to use imported 
bulk wine for further  processing, inconsistency with OIV labelling and winemaking rules, inspection 
of EU facilities by Russian officials, disqualification of wine -based products, etc). This is coupled with 
an extremely short deadline impossible to meet, lack of any transitional period nor stock -exhaustion 
clause as well as a successive legislative change in a short period of time. The EU is very concerned 
that wine business operators may have to simply stop marketing their products in the Russian 
Federation as from its entry into  force in June 2020. In addition to the issues posed by the Federal 
law itself, some of its requirements coincide with the technical requirements set out in the EAEU TR 
on alcoholic products, but some do not. For example , the federal law states that for wi ne the content 
of ethyl alcohol must be between 7.5 to 18%, whereas the EAEU TR sets the range between 8.5 to 
18%. Therefore the EU would like to ask how the Russian Federal Law and the EAEU TR relate with 
regard to mandatory technical requirements applica ble to wine; whether discrepancies between the 
EAEU TR and the Russian Federal Law are intended or accidental; whether the EAEU TR is directly 
applicable in Russia or not and, if not, whether Russia intends to adopt similar national measures 
applicable to other alcoholic products than wine covered by the EAEU TR but not by the above 
referenced Federal Law.  
1.347.   Lastly, it seems that the Federal Law also contains provisions covered by the Agreement on 
trade -related aspects of intellectual property rights. The EU would like to invite Russia to notify the 
measure to the Council for TRIPS. In view of these inconsistencies, the EU asks the Russian 
authorities to postpone the entry into force of this measure (planned for 26 June 2020) by at least 
one year, and grant a transitional period to further discuss the standards and explore whether 
business operators can progressively adapt them. The European Union would like to ask Russia to 
take these comments into consideration and to renotify the new version of the measure a s well as 
to notify the new wine measure, under the TBT Agreement as well as under the TRIPS Agreement.  
1.348.   In response, the delegation of the Russian Federation  provided the following statement. The 
Russian Federation would like to thank the European Union fo r its continued interest in the Technical 
 
64 See notably G/TBT/1/Rev.10  and G/TBT/35 , Coherent Use of Notifications Formats, Re commendation 
of the Committee on Technical Barriers to Trade Adopted at the meeting of 18 -19 June 2014.  G/TBT/M/81  
 
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  Regulation of the EAEU on safety of alcoholic beverages. The Technical Regulation has been adopted 
in December 2018 and enters into force on 9 January 2021. As for notifying the adopted text of the 
technical regula tion, the Russian delegation notes that the WTO transparency provisions require to 
notify draft technical regulations and conformity assessment procedures which Russia did. As for 
notification in the Council for TRIPS, we note that Article 63 of the Agreem ent on TRIPS requires 
notifications of the legislation in a sphere of intellectual property protection. The technical regulation 
as defined by the Annex I of the TBT Agreement cannot be referred to such kind of legislation. 
Technical Regulation on safety o f alcoholic beverages do not restrict right holders to register and 
use their GIs in Russia. As for physical and chemical requirements, we note mostly these 
requirements are already incorporated in the Russian national legislation and therefore would not 
represent something new for market players of the Russian alcohol market. Meanwhile, we would 
appreciate it if the European Union specify what particular physical and chemical requirements are 
of concern.  
1.349.   With regards to mandatory labelling requirements, we  reiterate statement s made over 
previous meetings of the TBT Committee. Requirements to inform consumers on the storage 
conditions and date of marking and bottling are used for consumer safety to avoid alcoholic 
intoxication or even fatal outcome. Stickers  are not prohibited by the Technical Regulation. 
Conformity assessment procedures are set in the Technical Regulation and applied to all alcoholic 
beverages both domestic and foreign. Mostly conformity assessment procedures do not change 
comparing to the o ne that are currently in place in Russia. As for the Federal Law № 468 of 
27 December 2019 on wine making in Russia, we note that according to the paragraph 2 of article 
52 of the Treaty on the EAEU, the technical regulations of the EAEU are directly appli cable in the 
territories of its member States. In this regard, product characteristics or their related processes 
and production methods with which compliance is mandatory as well as conformity assessment 
procedures are set by the Technical Regulation of t he EAEU on safety of alcoholic beverages.  
1.3.28   India – Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012 , G/TBT/N/IND/44 , G/TBT/N/IND/44/Add.1 , 
G/TBT/N/IND/44/Add.2 , G/TBT/N/IND/44/Add.3 , G/TBT/N/IND/44/Add.4 , 
G/TBT/N/IND/44/Add.5 , G/TBT/N/IND/44/Add .6, G/TBT/N/IND/ 44/Add.7 , 
G/TBT/N/IND/47 , G/TBT/N/IND/47/Add .1, G/TBT/N/IND/47/Add.1/Corr.1 , 
G/TBT/N/IND/47/Add.2 , G/TBT/N/IND/47/Add.3 , G/TBT/N/IND/58  (IMS ID 36765) 
1.350.   The delegation of the United States  provided the following statement. We understand that 
India's Ministry of Electronics and Information Technology (MeitY) has expanded the product scope 
covered under the Electro nics and Information Technology Goods (Requirements for Compulsory 
Registration) Order (CRO) to include an additional  12 new items as part of its CRO Phase IV. We 
recognize and appreciate India's 22 April 2020 notification to the WTO regarding the addition al 12 
items as part of CRO Phase IV ( G/TBT/N/ IND/44/Add.7) . The United States requests that India 
provide a stakeholder comment period of at least 60 days. The United States understand that the 
BIS is developing an Indian Standard based on IEC 62368 -1 and seeks to migra te to IEC 62368 -1 
by the end of 2020. To avoid duplication of compliance efforts and minimize burdensome compliance 
costs, the United States requests that India defer the rollout of CRO -IV until India adopts new 
standards based on IEC 62368 -1. The United S tates also requests that India share an update on its 
timeline and its plans to finalize the expanded product scope. India's CRO requirements continue to 
raise additional concerns, including the requirement that product testing be done only by Bureau of 
Indian Standards -accredited labs located within India; and the failure to recognize test results from 
internationally accredited labs.  
1.351.   The delegation of Canada  provided the following statement. Canada appreciates India's 
notification G/TBT/N/IND/44/Add.7  of 22 April 2020 in dicating the addition of 12 new products to 
the list of goods covered by the Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012. Canada seeks India's assurance that 60 days will be afforded 
to Members to com ment on this modification to the measure. Canada continues to seek: the use of 
international standards (e.g. ISO/IEC 17025 and ISO/IEC 17065); and the recognition of conformity 
assessment bodies accredited to international standards, except in specific cir cumstances where 
MRAs are needed to address particular risks, such as radio interference, before international 
conformity assessment bodies can be recognized.  
 
65 For previous statements follow the thread under IMS ID  367 (under dates raised  and references) . G/TBT/M/81  
 
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  1.352.   In response, the delegation of India provided the following statement. India would like to 
thank the United States and Canada for their continued interest in the matter. India had provided 
response to various queries raised by the Members on this issue during previous TBT Committee 
meetings and hence would not repeat the same here. However, India would like to provide certain 
additional information to the Members for further clarity. The "Electronics and Information 
Technology Goods (Requirement for Compulsory Registration) Order, 2012 " manda ting Indian safety 
standards for the notified goods has been notified for the safety of the consumers. Product categories 
are added to the Schedule of the Order in a phased manner following due consultation with the 
stakeholders. Recently, 12 additional pr oduct categories have been notified under the schedule of 
the "Electronics and Information Technology Goods (Requirement for Compulsory Registration) 
Order, 2012 " vide Gazette Notification No. S.O. 1236(E) dated 01.04.2020. The Order has also been 
notified  to the WTO TBT Committee. There is no change in the provisions of the Compulsory 
Registration Scheme and the Compulsory Registration Order. Further, minimum six months' time 
period has been given to the industry for compliance to the provisions of the Ord er from the date of 
publication of the regulation in the official gazette. It was published on 1 April 2 020. 
1.3.29   China – Registration Fees for Drugs and Medical Device Products ( IMS ID 46666) 
1.353.   The delegation of the Republic of Korea  provided the following statem ent. Korea would like 
to make following comments with respect to this regulation. Korea has continuously expressed its 
concerns over China's registration fees for medical devices. According to China's response from the 
previous TBT Committee meeting in Feb ruary 2020, it has incurred higher registration fees on 
imported medical devices due to the on -site inspection of foreign establishments. However, under 
Chinese laws, on -site inspection is not required for all overseas establishments of medical products. 
China's authorities also claimed that registration fees were determined mainly by the cost of 
conformity assessment, along with minor differences in the cost of manufacturing, workload, and 
the various price levels of the labour sector. According to our und erstanding, this does not explain 
why registration fees for imported products are roughly twice as high as those of domestic medical 
devices. During China's trade policy review in 2016, China mentioned that the registration fees are 
adjusted every five yea rs based on re -evaluation results. Since five years have passed since the last 
adjustment, Korea anticipates seeing substantial progress on this matter this year. We kindly request 
China to take our comments into account during the revision process, share information on revision 
plans, and notify the revision to the WTO. Further, we request that China share any information 
pertaining to the revised implementation rules.  
1.354.   The delegation of Australia  provided the following statement. Australia maintains an on -
going interest in developments in China's regulation of drugs and medical devices. Australia 
continues to look forward to constructive bilateral discussions with China on a range of health 
technology topics of interest to both sides, and to further coopera tion and information exchanges. 
The Australian Government welcomes the opportunity to build its relationship with the N MPA and 
the Pharmaceuticals Division of the Chinese Ministry of Industry and Information Technology (MIIT).  
1.355.   In response, the delegation o f China  provided the following statement. The registration fees 
for drugs and medical devices were determined mainly by the cost of the conformity assessment. 
The minor difference in the registration fees between imported and domestic products was due to 
the different costs of manufacturing.  
1.3.30   Indonesia – Halal Product Assurance Law No. 33 of 2014 , G/TBT/N/IDN/123  (IMS 
ID 50267) 
1.356.   The delegation of the European Union  provided the following statement. The European Union 
would like to reiterate its serious concerns on the Indonesian Halal Product Guarantee Law No 33 of 
September 2014, which requires mandatory Halal certification and labelling for the products under 
its very wide scope to be placed in the Indonesian market. The European Union stresses that, 
contrary to Article 2.9 of the TBT  Agreement, neither the Halal Law nor the first Implementing 
Regulation PP No 31 of 2019 were notified to the TBT Committee. We acknowledge the notification, 
on 14 October 2019, of a draft second Implementation Regulation and thank the Indonesian 
authoriti es for their reply of 13 March 2020 to our comments of 6 December 2019. We have 
expressed further concerns in our follow -up comments of 27 April 2020. In December 2019, 
 
66 For previous statements follow the thread under IMS ID  466 (under dates raised and references) . 
67 For previous statements follow the thread under IMS ID  502 (under dates raised and references) . G/TBT/M/81  
 
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  Indonesia notified to the TBT Committee a Regulation on Processed Food Labelling, relev ant for the 
implementation of the Halal Law. The EU would like to stress that the proposed Halal measures 
would have a restrictive impact on trade flows and firmly calls upon Indonesia to reconsider its 
approach and keep Halal certification and labelling v oluntary, limiting its effects to the legitimate 
objective of ensuring reliable information. In accordance with the relevant provisions on 
transparency in the TBT Agreement (Article 2.9), the EU invites Indonesia to notify to the TBT 
Committee any measures  adopted for the proper implementation of the Halal Law, for instance on 
the certification fee, and to allow reasonable time for comments, as well as a reasonable interval 
between their publication and enforcement.  
1.357.   Regarding substantial aspects, we would l ike to refer to several points. In line with 
Implementing Regulation PP No 31 of 2019, all products produced, imported and distributed in 
Indonesia claiming to be Halal must be Halal  certified. The European Union acknowledges the 
possibility to place "non-Halal" products in the Indonesian market and, in this respect, the fact that 
there is no obligation for "non-Halal" products to be certified. However, neither the Halal Law nor 
the implementing provisions specify clearly the list of Haram products. Moreove r, the EU considers 
that the requirement for "non-Halal" information is unnecessary and unpractical and creates an 
excessive burden for operators. In the absence of a Halal claim from the producer, no 
labelling/information obligations are justified. The EU  insists that there should be also coexistence 
of "Halal" and non -"Halal" products without a time limitation for medicines, biological products and 
medical devices.  
1.358.   Since 17 October 2019, the Halal Law is in its first stage of application, under which foo d 
and beverages derived from animal raw materials, including fresh and processed food, are required 
to obtain Halal certification and labelling. The EU considers that the grace period of five years 
expiring on 17 October 2024 for food and beverages to comp ly with the Halal Law is a huge challenge 
for economic operators and certification bodies, taking into account the operations involved (i.e. 
auditing, storage, transport) and would like to ask for an extension. The European Union invites 
Indonesia to respe ct the provisions included in the "Codex Alimentarius Guidelines" for the use of 
the term "Halal" in food labelling, which permit the processing of "Halal" and non -"Halal" products 
within the same premises and their transport in the same facilities, provided that appropriate 
cleaning measures are taken to prevent any contact between them. In addition, the European Union 
is of the view that the extension of Halal requirement s to products other than food and beverages 
would be disproportionate. In any case, we would be interested in having further practical 
information on the gradual implementation of the Halal Law for the different sets of products covered 
and on the "Memoran dum of Understanding " recently signed by the Indonesian authorities on 
enforcement.  
1.359.   The EU takes note that products with recogni zed foreign Halal product certification and 
distribution permits in Indonesia do not need to re -register for new Halal certifica tion until expiration 
of the existing certificates. However, the requirement to have a cooperation agreement between 
foreign Halal certification bodies and the Indonesian Halal Products Assurance Agency (BPJPH) – as 
a pre -requisite for recognition of Halal  certificates – is cumbersome and not proportionate. The EU 
also regrets that, in the absence of this cooperation agreement, manufacturers need to go through 
the full Halal certification process in Indonesia, which for a foreign company is excessively 
burdensome in terms of duration and administrative effort. The additional registration requirement 
with BPJPH for Halal certifications issued by foreign bodies appears to be duplicative, time consuming 
and impractical and the EU invites Indonesia to consider l ess cumbersome and non -discriminatory 
practical solutions to allow products certified Halal by foreign bodies to enter and circulate in the 
Indonesian market. The EU insists that Indonesia accepts test reports from EU laboratories 
accredited by an accredit ation body member of the international arrangements for mutual 
recognition of the International Laboratory Accreditation Cooperation (ILAC) and the International 
Accreditation Forum (IAF).  
1.360.   The delegation of the United States  provided the following statemen t. The United States 
recognizes the importance for Indonesian consumers to know whether products are halal. We want 
to work with you to ensure that the law achieves your objective without creating any unnecessary 
barriers to trade. We thank Indonesia for i ts response to the U S Government and U S industry 
comments on the Ministry of Religious Affairs (MORA) Regulation on Implementation of Halal Product 
Assurance, which it notified to this Committee in G/TBT/N/IDN/123 . We understand, however, that 
Indonesia finalized and issued another  implementing regulation of the Halal Law in early May, 
Government Regulation 31 of 2019 on "Implementation Provisions of Law 33/2014 regarding Halal G/TBT/M/81  
 
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  Product Assurance, " which Indonesia has not notified to this Committee. We again ask that Indonesia 
notify  this measure, and any additional implementing measures, to the Committee. Furthermore, 
we understand that the Halal Product Assurance Agency is starting to develop implementing 
measures and guidance for specific product categories. Can you confirm the fol lowing list of products 
are in the scope and the envisioned timeline for the requirements to go into force: October 2024 for 
"food and beverage products "; October 2026 for "traditional medicine and health supplements, " 
"cosmetics, chemical product and gene tically engineered products, " "clothing, headgear and 
accessories, " "household appliances, Muslim worship equipment, stationery and office equipment, " 
and "goods for medical devices risk class A "; October 2029 for "medicines " and "goods for medical 
devices  risk class B "; October 2034 for "prescription drugs, excluding psychotropic " and "goods for 
medical devices risk class C "? 
1.361.   We also await clarification about the status of proposed legislation connected with the 
following category: "Medicinal product, biol ogical product and medical equipment made from non -
Halal raw material or non -Halal processing, " as listed in the notification to this Committee. We ask 
that Indonesia specify what is the envisioned process and timeline for notifying and soliciting public 
comment on the implementing measures regarding the certification, packaging, and labelling 
requirements for each of these product categories. In developing these requirements, we ask that 
Indonesia consider the comments we submitted expressing concerns as to the feasibility and 
necessity of requiring that all categories of covered products have separ ate manufacturing, 
processing, storage, packaging, distribution, and sale facilities for Halal versus non -Halal products. 
We remain concerned by Indonesia's explanation at the February 2020 TBT Committee meeting that 
"naturally Halal" food and beverage pro ducts considered exempt from the new Halal Law did not 
include fresh fruits and vegetables that had been frozen. Can Indonesia explain why the process of 
freezing would require a Halal certification? Further, we continue to seek clarity on the status of bu lk 
shipments.  
1.362.   We request further information regarding Indonesia's response to U S Government comments 
regarding required label ling for non -Halal products. Can you refer us to the applicable laws and 
regulations from Indonesia's National Agency of Drug and Food Control (BPOM/NADFC) that are 
referenced in Indonesia's response? As that refers to requirements for food and cosmetic products, 
what will be the requirements for other product types? We request that Indonesia provide sufficient 
transition time for st akeholders to understand and comply with the requirements in these 
regulations. We understand that the MORA implementing regulation will allow for phased 
implementation of mandatory Halal certification requirements and that Indonesia will continue to 
allow the sale of non -certified products. Can Indonesia confirm our understanding? We would like to 
thank Indonesia for extending the recognition of foreign Halal certification bodies so that halal -
certified agricultural products can continue to enter Indonesia  uninterrupted during this transition 
time. For the United States, the current recognition of our five U S-based Halal certifiers will begin 
expiring on 5 June 2020. To ensure the continuation of trade, we request that Indonesia extend 
recognition of the cu rrent five U S-based Halal certifiers for two years to prevent trade disruptions 
for Indonesian industry while the Halal Product Assurance Agency (BPJPH) streamlines its recognition 
application process. We understand these five certifiers have started the a pplication process but 
received minimal feedback on their applications.  
1.363.   We remain concerned with the mandatory requirement that both "Halal" and "non-Halal" 
products be labelled. Mandating labels for both Halal and non -Halal information will create confusion 
for consumers and will be costly and challenging for companies, both foreign and domestic, to 
implement. We understand there is also a registration requirement for each foreign Halal certificate 
included in the implem enting regulations, including a requirement that the certificate registration 
numbers be included on the product label. As written, the registration requirement for importers is 
cumbersome, duplicative, and has the effect of restricting trade. Further, we do not see how the 
same registration requirements would apply to local products. We request that Indonesia modify 
this registration requirement to reflect the fact that Indonesia's Halal Product Assurance Agency 
("BPJPH ") will already be conducting verific ations of foreign Halal agencies issuing Halal certificates 
for imported goods. We ask that Indonesia provide greater specificity as to which medical devices 
will be subject to the Halal Law's implementing regulations. We also ask Indonesia to clarify thei r 
response to the U S medical device industry request to exclude in-vitro diagnostic products made of 
animal material, which are not exposed to the human body from the scope of the Halal Law. We are 
encouraged by Indonesia's notification of the MORA regulat ion and urge Indonesia to notify all 
previous and forthcoming implementing regulations in their draft form prior to their finalization and G/TBT/M/81  
 
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  again request transparency as these rules are developed to provide adequate transition time, and 
an opportunity for s takeholder comments.  
1.364.   The delegation of Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. Indonesia implemented the Halal Product Assurance Law on 17 
October 2019. Although Indonesia has fulfilled its obligatio n to notify the TBT Committee, it has not 
yet announced detailed implementation rules. The Separate Customs Territory of Taiwan, Penghu, 
Kinmen and Matsu stakeholders and certifying bodies hope to be informed so that they can respond 
accordingly. We are eq ually interested in this case along with other Members and would like to 
request Indonesia to provide information on the mechanism of mutual recognition between 
Indonesian Halal Product Assurance Organizing Agency (BPJPH) and foreign halal institutions so that 
our Halal products can successfully enter the Indonesian market.  
1.365.   The delegation of Canada  provided the following statement. Canada would like to thank 
Indonesia for its engagement on this issue. However, we would like to reiterate that Canadian 
export ers still require additional information on how the Halal Product Assurance Law will be 
implemented in order to successfully comply with its requirements. We appreciate receiving 
confirmation that fresh plant ingredients, such as grains, fruits and vegetab les, will not need to be 
certified under the Halal Product Assurance Law unless as they are considered "toxic" to people who 
consume it. Canada looks forward to receiving additional clarification from Indonesia on what the 
term "toxic" means. We would like to reiterate our concern regarding the mandatory requirement 
for the labelling of Halal and non -Halal food, which, in our view, could be confusing for consumers 
and difficult for manufacturers to implement.  
1.366.   Canada is still waiting fo r clarification of how this law will apply to frozen food. It is our 
understanding that fresh seafood is exempt from the Halal certification and labelling requirements 
but that frozen plant products and seafood are considered "processed " under the regulati on and will 
therefore require Halal certification and labelling. Canada is concerned that fresh crabs exported to 
Indonesia will not need to be Halal certified but if those same crabs are frozen certification will be 
required. Canada understands that this certification applies to all frozen single -ingredient products 
like fruit and vegetables. This requirement could disadvantage imported products that must be 
frozen in order to maintain freshness during transport and cause confusion among consumers. 
Canada exported almost C AD 43 million worth of frozen crabs to Indonesia in 2019. Can Indonesia 
explain how the freezing process makes a crab or blueberry non -Halal? 
1.367.   The product accreditation process for foreign Halal certifying organizations also remains 
unclear . Does Indonesia intend to publish further guidance on the Halal certification process 
certifying organizations must follow before the Halal Product Assurance Law and implementing 
regulations are fully in force? Can Indonesia explain why the Halal Products  Assurance Agency will 
require a cooperation agreement? This requirement would be difficult for countries that do not have 
a mandate for Halal food. Is Indonesia taking this into consideration as further implementing 
measures area put in place? Will furthe r guidance be notified to the TBT Enquiry Point? Will a public 
comment period be provided? Canada encourages Indonesia to provide timely information as further 
implementing regulations are developed to provide trading partners with sufficient time to comme nt 
and seek clarifications as needed.  
1.368.   On the accreditation of foreign certification bodies, we understand that Indonesia has 
extended the recognition of foreign bodies whose recognition was still valid but has a future expiry 
date. However, this does not a pply to foreign bodies whose recognition has already expired. Can 
Indonesia confirm that the outstanding applications of certification bodes whose recognition has 
expired will be processed as soon as possible? Canada would like to express serious concern o ver 
this long outstanding issue as the application of a Canadian certification body has been outstanding 
since 2016. As a result of this delay a shipment of certified halal beef was rejected on 3 February 
2020.  
1.369.   The delegation of New Zealand  provided the fo llowing statement. New Zealand supports 
concerns raised by other Members. New Zealand would again like to thank Indonesia for the timely 
and informative response to our enquiries on the draft regulation of M ORA regarding the 
implementation of Halal Product  Assurance notified under G/TBT/N/IDN/123 . In reference to Article 
29 para (2), New  Zealand continues to seek further guidance on the timeframe for release of the 
draft ministerial decree that will stipulate the type of products that must be Halal certified. We ask 
for some clarity  on the status of Halal Certification Organisations whose certification will soon expire G/TBT/M/81  
 
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  or has already expired with MUI, and whether there are any transitory arrangements in place for 
them to continue to certify before the release of the ministerial decre e noted above and the 
conclusion of Mutual Recognition Arrangements or other agreements. We appreciate any further 
information from Indonesia as to whether there are any other regulations relating to Halal under 
development, in addition to the Minister of Religious Affairs' regulation noted in your response. We 
understand that the Halal certification fees will need to be set in a Ministry of Finance regulation and 
welcome any further clarification on this. We also understand that the latest version of the O mnibus 
Bill on Job Creation may include revisions to the Halal Law 33/2014. Can Indonesia provide any 
further guidance on what these proposed changes may include and how they will affect the proposed 
Halal Assurance system.  
1.370.   The delegation of Brazil  provide d the following statement. Brazil supports the concerns raised 
by the EU, Canada, the US and Chinese Taipei. In the process of implementing Halal Product 
Assurance Law 33 of 2014, Brazil encourages Indonesia to fully comply with its transparency 
obligation s under the TBT Agreement. For instance, regulation 31 on "Implementation Provisions of 
Law 33/2014", which came into force in May 2019, has not yet been duly notified to the WTO. Could 
Indonesia please confirm if it intends to notify new measures related to Halal Product Assurance Law 
33 of 2014? As far as we can ascertain, Indonesian regulations have not yet established the list of 
international certifiers authorized by the Indonesia's Halal Product Assurance Organizing Agency 
(BPJPH). Neither have the y defined certification requirements for specific types of products. Until 
there is a clear definition of such requirements, we understand that Law 33 and its subsequent 
regulations will not be implemented. Can Indonesia either confirm or deny this understand ing? We 
would also like to ask Indonesia to provide a time frame  for the publication of future regulations 
related to Halal certification, as well as to notify such measures to the WTO accordingly. Finally, 
Brazil thanks again Indonesia for having partially  clarified that "non -Halal" labelling for products 
containing "non -Halal" substances would not be necessary. We kindly ask Indonesia to further clarify 
this understanding on its new legislation, as well as the possibility of coexistence of Halal and non -
Halal products.  
1.371.   The delegation of Australia  provided the following statement. Australia thanks Indonesia for 
the positive exchange to date. We are looking forward to continuing collaboration with Indonesia on 
the implementation of its new Halal Law.  
1.372.   In respo nse, the delegation of Indonesia  provided the following statement. Indonesia thanks 
the USA, the EU, Canada, Chinese Taipei, Brazil, and New Zealand for raising the issue on Halal 
Product Assurance Law No. 33 of 2014. Indonesia stresses that Halal certification aims to guarantee 
the integrity of Halal products circulating in Indonesia to enable consumers to make informed 
decision on dietary choices based on religious believe. This is also based on consideration that 
Indonesia has the largest Mu slim population in the world. Indonesia would like to reiterate its last 
statement in February meeting that the Halal law will not either ban the sale of non -Halal products 
in Indonesia nor require non -Halal products to be certified. Non -Halal products are  only required to 
provide information of its non -Halal ingredients in the package of the product.  
1.373.   As mentioned in the draft of the implementing regulation (Draft Decree of Minister of 
Religious Affairs regarding The Implementation of Halal Product Assuranc e, notified in 
G/TBT/N/I DN/123) , products that use ingredients from and/or containing pork must be separated 
from products that will undergo Halal certification process. In the situation where products that want 
to be Halal certified use the same production facilities with produc ts that do not require Halal 
certificate and do not contain pork and/or its derivatives then it can provide the following documents: 
name and type of the products, list of products and materials used, product processing and washing 
or tanning at production  facilities that are used together.  
1.374.   Provisions on Halal labelling and non -Halal information for pre -packaged food are subject to 
the Regulation of National Food and Drug Agency of Indonesia as notified in G/TBT/N/IDN/124 . 
Indonesia reaffirms its openness to international cooperatio n with foreign halal institutions or 
authorities. Cooperation with foreign Halal institutions will prioritize the principle of mutual 
recognition and mutual acceptance in accordance with international regulations and practices. The 
implementation of this c ollaboration will begin with government  to government  cooperation. 
Indonesia acknowledges Halal certificates issued by foreign Halal certification bodies that have 
cooperated with BPJPH, meaning that all Halal certificates issued by those foreign Halal cer tification 
bodies can be accepted as compliance with Halal requirements in Indonesia. All Halal certificates 
from foreign Halal certification bodies must be registered to BPJPH before the products are G/TBT/M/81  
 
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  distributed in Indonesia. This procedure is a requireme nt that must be met as compliance to import 
process.  
1.3.31   Russian Federation – Rules of cement certification , G/TBT/N/RUS/48 , 
G/TBT/N/RUS/49  (IMS ID 49768) 
1.375.   The delegation of the European Union  provided the following statement. The EU would like 
to refer to its previous statements in the TBT Committee on this issue. Both Russian notifications 
G/TBT/N/RUS/48  and G/TBT/N/RUS/49  referred to measures that were already adopted and had 
entered into force at the time of their notification. This is not in li ne with the provisions of the TBT 
Agreement (Article 2.9). The EU would like to highlight that its comments on these two measures 
sent to the Russian Federation in May and June 2016 were never replied to. The EU deeply regrets 
that Russia continues to adop t restricting measures in the area of cement certification that are 
disproportionate, unjustified and not notified to the WTO before their entry into force. Since the 
introduction of the mandatory certification for cement, EU exports of cement to the Russi an 
Federation are practically blocked , with the exception of white cement, necessary for Russian 
industry. In light of the above, the EU welcomed the announcement of the Russian authorities 
declaring that the standards on cement certification would be revi sed and a new standard eliminating 
additional inspection procedures would be notified to the WTO at a draft stage. In the margins of 
the TBT Committee in November 2019 the Russian authorities confirmed that the new standard on 
cement would soon be notified  in accordance with the TBT Agreement. Given the lack of the 
notification to this day, the EU would like to ask the Russian Federation to share the updated timing 
for this notification.  
1.376.   In response, the delegation of the Russian Federation  provided the fol lowing statement. The 
Russian Federation would like to thank the European Union for its continued interest in the rules of 
cement certification. The measure at issue is aimed at fighting illicit trade in cement and building 
materials and ensuring the stren gth of building materials which is of paramount importance for the 
durability of buildings. Currently, the amendments to GOST – R "Rules of cement certification " are 
being discussed internally among the relevant Russian authorities and the cement industry.  
Unfortunately, no precise timeline for the outcome of the discussion can be provided at this stage.  
1.3.32   India – Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulations, 2015 , G/TBT/N/IND/51  (IMS ID 49469) 
1.377.   The delegation of the European Union  provided the following sta tement. The EU would like 
to reiterate its concerns regarding this measure. The EU welcomes the publication of the regulation 
on additives for alcoholic beverages in August 2017, though not all our concerns were taken on 
board. The regulation covering stan dards for alcoholic beverages was published in April 2018, and 
is being implemented since April 2019, with the exception of the parameter for yeast in various 
categories of beer and the modification of certain specific provisions, for which an extension of  six 
months had been announced. The EU also welcomes the notification to WTO in July 2019 of a number 
of amendments to the standards ( G/TBT/N/IND/104) . The EU sent comments on 26 November 2019 
and would welcome a reply.  
1.378.   We would like to thank India for having taken most of our co mments into account, and for 
the six -month extension of the deadline for certain provisions to enter into force. However, we still 
have some concerns with this Regulation. We notably request Indian authorities to consider 
alignment with OIV standards. In p articular, we would appreciate if India could take into account 
the following. The lack of stock -exhaustion clause (to allow the sale of products already present on 
the Indian market until stocks are exhausted in order to minimi ze the impact for economic o perators) 
and transition period. The presence of some technical specifications (maximum alcohol content, 
sugar content, some wines' definitions) that may not be in line with international standards or with 
international widely accepted practices and could result in an adverse impact for international trade. 
This would prevent some EU wines, spirits or beers to enter the Indian market. Some labelling 
requirements are excessive (residues of additives in the final product) and will potentially trigger 
addition al technical controls that might result in unjustified barriers to trade. The Regulation also 
includes the need to satisfy excessive analytical parameters that would result in additional technical 
 
68 For previous statements follow the thread under IMS ID  497 (under dates raised a nd references) . 
69 For previous statements follow the thread under IMS ID  494 (under dates raised and references) . G/TBT/M/81  
 
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  controls (residual extracts, higher alcohol, iron). These a dditional technical controls might result in 
unjustified barriers to trade.  
1.379.   A meeting of the Scientific Panel of FSSAI took place in March 2019 to discuss the most 
important outstanding EU concerns and rejected most of our requests. Another meeting of the 
scientific panel took place in the autumn 2019 and discussed the EU request on food 
additives/colorants used for Campari and Aperol. According to oral information, the panel accepted 
the colorants but concluded on lower quantities as permitted in the EU. W e would welcome to receive 
confirmation from the Indian authorities that the food additives to be used in Campari and Aperol 
have indeed been approved by the scientific panel. We would also welcome to learn about the 
timeline for the entire approval proced ure until its final publication in the Gazette. We expect that 
the EU (and other Third Countries) will have the possibility to comment on the draft legal proposal. 
We hope that we can continue our discussion and find an acceptable solution to the outstandi ng 
issues.  
1.380.   The delegation of Australia  provided the following statement. Australia recogni zes the right 
of the Indian Government to take measures necessary to protect public health compliance with WTO 
obligations. Australia thanks India for the on -going  bilateral engagement on the proposed 
amendments to its F SSR, and appreciates advice from the F SSAI that the proposed amendments 
have been revised to address our comments. Australia considers India's proposed amendments to 
the regulations in relation to alcoh olic beverages would restrict the ability of winemakers to adapt 
to warming climates, both in Australia and India. As noted at the previous TBT Committee meeting, 
wine producers in Australia are permitted under the Australia New Zealand Food Standards Code  to 
add water to dilute high sugar musts to aid in fermentation. The addition of water is done in minimal 
circumstances, for technical necessity, in small volumes to aid fermentation.  
1.381.   Australia continues to encourage India to permit the addition of limited  amounts of water to 
facilitate fermentation to enable winemakers to effectively respond to "stuck fermentations ". 
Australia thanks FSSAI for inviting Australia to provide alternative wording for the regulations to 
enable this outcome. Australia also notes  the proposed amendment wording to "…declare the range 
of sugar as specified under these regulations ", and is concerned this wording may cause confusion 
as to whether winemakers should state the sugar content or provide a statement such as "brut", 
"dry" or "sweet ", as proposed in another section of the regulations. Australia would appreciate 
clarification regarding the above wording, requests confirmation the proposed amendments have 
been revised to address our comments, and encourages India to re-notify  WTO Members of the 
changes. We thank India for its on -going  engagement with Australia on these issues and look forward 
to continuing our constructive engagement.  
1.382.   In response, the delegation of India provided the following statement. India would like to 
thank the European Union and Australia for their interest in the matter. On the issues raised for this 
measure, India would like to mention a few points as indicated below. The Food Safety and Standards 
(Alcoholic Beverages) Regulation, 2018 was gazette noti fied on 19  March 2018. As per this 
notification, a transition period up to 1 April 2019 was allowed to the Food Business Operators to 
comply with these regulations. Additionally, as per Direction under section 16 (5) of FSSA Act, 2006 
dated 29  March  2019, a time period of six months was given for use of old unused labels and printed 
cans. Moreover, the alcoholic beverages manufactured prior to 1 April 2019 could be sold in the 
market up to 31 March 2020 or until the finalization of the amendment regulations  incorporating 
modification mentioned, whichever is later. Further, one -time relaxation by the respective State/UT 
Governments for fee charged for registration of new/change in label, as required under Excise Act, 
was also provided.  
1.383.   So far as clarification  sought on issues related to wines are concerned, it is informed that 
the definitions with respect to  wines are being considered for suitable amendment. On the issue 
related to declaring the sugar range in wine, it has been kept as a part of consumer aware ness. 
Instead of actual sugar content, the range given for different types of wines , i.e. dry, sweet , etc., 
has to be provided. A clarification in this regard has been uploaded on the FSSAI Website in the form 
of FAQs on Gazette notified Alcoholic Beverage s Regulations, 2018. Further, it is informed that the 
limit of addition of water in wine has been revised and harmonized with FSANZ . The alcoholic 
beverages shall conform to all the requirements specified in the Food Safety and Standards (Alcoholic 
Beverag es) Regulations, 2018 and the labelling requirements are to be followed as specified in this 
Regulation. India does not consider it necessary to renotify WTO Members of the changes in the said 
Regulation as the draft Notification on Food Safety and Standar ds (Alcoholic Beverages) Amendment G/TBT/M/81  
 
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  Regulations, 2019 was uploaded on FSSAI website and notified to WTO TBT Committee in July 2019. 
If there are any additional issues, India is ready to discuss the same bilaterally for providing further 
clarity in the matte r. 
1.3.33   Egypt – Manufacturer Registration System (Decree No. 43/2016 and Decree No. 
992/2015) , G/TBT/N/EGY/114 , G/TBT/N/EGY/115  (IMS ID 50570) 
1.384.   The delegation of the European Union  provided the following statement. The EU would like 
to reiterate its concerns with regard to the Egyptian requirements on registration  of manufacturers 
and importers. The EU would like to thank the Egyptian authorities for their efforts to make the 
registration function more efficiently and for the communication dated 12 February 2020 on the 
status of EU pending registration requests. Ne vertheless, the EU regrets that many pending 
registration cases known to the EU have not been successfully processed due to expired application 
documents. According to the understanding of the EU, this concerns quality control system 
certificates with one-year validity, which expired due to the failure of the General Organization of 
Export and Import Control (GOEIC) to register the companies within reasonable time limits. As a 
result, the European companies are now confronted with additional costs and admin istrative burden 
of updating their registration applications. Moreover, the EU finds it very worrisome that more than 
half of the non -registered companies happen to be active in the sector of ceramics, and in particular 
ceramic tiles. The EU ceramics secto r has been disproportionately affected by the discretionary 
application of Decree 43/2016, with practically no registrations taking place since the introduction 
of the Decree in 2016. The EU would appreciate if all the companies, which submit updated quali ty 
control system certificates and complete in this way their application documents, are registered 
without any further delay.  
1.385.   While the EU appreciates as improvement the creation of the registration committee in the 
Egyptian Ministry of Trade, this does n ot resolve the structural problems related to the Decree 
43/2016, like the lack of transparency of the registration process, lack of clear deadlines for 
processing the requests and lack of a clear appeal procedure. The EU would therefore like to repeat 
its invitation to Egypt to suspend or further substantially improve the registration process with a 
view to liberali zing trade and to refer for details to the statements of the past TBT Committees. 
Finally, the EU would like to ask Egypt to temporarily suspen d the requirement to stamp and legalise 
documents submitted for registration of exporting factories under Ministerial Decrees 43/2016 2016 
and 44/2019, due to the exceptional circumstances caused by the COVID -19 pandemic.  
1.386.   The delegation of the Russian Fede ration  provided the following statement. The Russian 
Federation remains concerned with the Egyptian registration procedures under the Decree 
№ 43/2016 and reiterates the statements made during the previous meetings of the Committee on 
TBT and the Council f or Trade in Goods. We continue to receive messages from Russian exporters 
that the registration procedure is burdensome, time consuming, untransparent and represent s a 
discriminative barrier for trade. Stark example of these words is the case of a Russian exporter of 
steel reinforcement bars. The company has been trying to get registered since 2016. The damage 
to the company due to denied market access is estimated at USD 100 million  annually which makes 
compound damage to date up to USD 0.5 bi llion. Given so lengthy a procedure some of the submitted 
documents expire. In the case of the particular exporter quality management certificate, 
environmental management certificate as well as  trademark certificate had to be renewed. In this 
regard, we urge Egypt to provide Russian companies with the market access as per Egypt's 
commitments in the WTO.  
1.387.   The delegation of Turkey  provided the following statement. We would like to thank Egypt for 
continuing bilateral discussions on this issue. However, we continue to hear from Turkish exporters 
that exporting Turkish products to Egypt has become more challenging. According to the recent 
information, General Organization for Import and Export Control  (GOEIC) of Egypt suspended the 
registration of 672 companies in total and halted export of goods due to expired application 
documents. We have also been informed that 123 of these companies are Turkish companies. In 
other words, one of every four companie s whose exports are suspended is a Turkish company. While 
GOEIC has suspended the registration due to the out -of-date documents, the Egyptian authorities 
have not given any additional information regarding the details of the deficiencies. In addition to 
this, we have been informed that if the deficiencies are not completed by 31 May 2020, which is a 
 
70 For previous statements follow the thread under IMS ID  505 (under dates raised and references) . G/TBT/M/81  
 
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  short period of time, the exporting companies have to apply to GOEIC with a new application file 
starting from very first step of the registration process.  
1.388.   Besides the suspension of the registrations, there are many companies still awaiting approval 
since the introduction of Decree 43/2016. Although there have been some progress, around 160 
Turkish companies applied for the registration are still waiting for their application to be approved. 
The list of the companies has been submitted to the Egyptian side on various occasions, but no 
meaningful progress was achieved. We have repeatedly stated in the previous Committee meetings 
that the application process is not transparent, and it is still unclear how the applications are 
evaluated, and whether the completion of the process is subject to any time limits. In addition, no 
notification is made to companies on the status of their application whether it is approve d or not. 
Therefore, Turkey still remains concerned with this non -transparent registration process. Further, 
we have also not received any contact information for the new Committee that was established by 
the Egyptian side for the registration system. In t his regard, we expect an improvement and tangible 
steps from Egyptian side to move ahead.  
1.389.   In response, the delegation of Egypt  provided the following statement. We thank the 
European Union and Russia for maintaining this item on the agenda, and we would al so like to 
express our appreciation for the bilateral exchanges we have had with a couple of delegations in this 
respect. Further transparency in the application of the registration system was one of the main 
concerns raised by our trading partners with re gard to Egypt's decrees 43/2016 and 44/2019. And 
it is in this vein that the G OEIC of Egypt has published on the 22 April on its website a full list of the 
companies whose registration is suspended due to the incompletion of the required documents, 
grantin g these companies a grace period until 31 May to fulfil the needed documentation in order to 
avoid the need to file a new application. And with regard to the developments of the number of 
registered companies as well as the company -specific problems convey ed to us by the concerned 
delegations in Geneva, we are currently following up with Cairo in this respect, noting that the 
lockdown in our capital as well as the restrictive measures taken by Egypt to contain the COVID -19 
pandemic have made the coordinatio n among the different governmental authorities as well as with 
the mission in Geneva more challenging. Therefore, we would like to thank the Members who 
conveyed to us the details of the problems faced by their companies, and we shall revert to them 
bilate rally upon receipt of the feedback on these cases from the capital.  
1.3.34   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 50971) 
1.390.   The delegation of the European Union  provided the following statement.  The EU would like 
to refer to concerns r aised in our several previous statements in the Committee concerning these 
notifications. The EU understands that there will be one new mandatory standard pertaining to plastic 
furniture. The EU would like to underline to China the need to notify this stan dard in accordance with 
the TBT Agreement. In addition, the EU would like to receive a confirmation from China what, if any, 
relationship this announced mandatory national standard "Limits of Dangerous Substances for Plastic 
Furniture " (GB 28481 -2012) woul d have to the standards previously notified to the WTO 
(G/TBT/N/CHN/1094 , G/TBT/N/CHN/1095  and G/TBT/N/CHN/1096 ). To help further facilitate the 
timely implementation of furniture -related standards, the EU would also like to know whether the 
new standard would have implications for any other furniture groups, besides plastic furniture. The 
EU would like to reiterate that it r emains open to hold technical discussions in any suitable manner 
on issues pertaining to these and any other relevant furniture standards, as originally proposed by 
China in June 2017. To this end, the EU renews its request for China to designate its conta ct point 
for the organi zation of such meeting. The EU once again would like to respectfully remind China to 
notify the announced standard in accordance with the TBT Agreement.  
1.391.   In response, the delegation of China  provided the following statement. The stand ard is still 
under the process of drafting, which is under the responsibility of the M IIT of China. MIIT is expected 
to complete the preparation of the draft standard in the first half of 2021 and then will be submitted 
to the Standardization Administratio n of China for approval. During the developing process of the 
standard, we will adhere to the principle of open and transparent, take ISO standards into account 
and solicit opinions and comments from all sectors of society, including opinions from foreign -
invested enterprises and experts.  
 
71 For previous statements follow the thread under IMS ID  509 (under dates raised and  references) . G/TBT/M/81  
 
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  1.3.35   China – Cybersecurity Law ( IMS ID 52672) 
1.392.   The delegation of the European Union  provided the following statement. The EU would like 
to refer to the comments it has made in previous TBT Committees with regard to the Cybersecur ity 
Law. The scope of the requirements is unclear, as key terms have not been specified in sufficient 
detail. Concepts such as "critical information infrastructure" and "secure and trustworthy products" 
are not sufficiently clarified. The EU maintains its concerns about the revised methodology. While 
references to "source code " have been removed, the mere requirement of providing "relevant 
materials " to verify the security and controllability of products, could imply source code disclosure. 
The EU recalls t he importance of international standards and notes that the law only makes 
references to national standards. This could lead to lack of interoperability with international 
standards. In the development of national standards, it would be appropriate to buil d on existing 
international standards and to involve all relevant stakeholders, including foreign invested and 
wholly -foreign owned enterprises, in a non -discriminatory manner in the relevant Technical 
Committees.  
1.393.   The EU would like to request more clarity regarding several of the implementing measures 
following China's Cybersecurity Law. For example, the Cyberspace Administration of China's Cross -
Border Data Transfer Measures continue to raise concerns about the broad scope of these 
regulations, regarding w hat is considered as Critical Information Infrastructure and which kinds of 
cross-border data transfers are affected. A definition of critical information appears to cover many 
commercial activities and whole sectors that have no bearing on national securi ty. Moreover, the list 
of what is considered important data is open  ended. As a result of the data locali zation and security 
assessment requirements, foreign companies operating in China could find themselves in a less 
competitive situation compared to dom estic operators.  
1.394.   As regards the certification and security requirements on Critical Information Infrastructure, 
the EU is concerned that such requirements lead to a de facto  ban on products and services from 
foreign -invested enterprises providing products and services to businesses falling under the notion 
of "critical information infrastructure". The EU is also concerned about the wide scope of the 
measure. The EU calls on China to implement these provisions in a non -discriminatory manner, 
respecting the p rinciples of proportionality, necessity and technology neutrality, and ensuring 
adequate protection of intellectual property (IP). Moreover, the EU would like to repeat its previous 
requests for clarifications on the relationship with existing Multi -Level Protection Schemes and the 
expected implementation timeline. The EU notes with concern that the Cybersecurity law already 
applies and is enforceable (including possible fines and sanctions), while the implementing measures 
that would clarify its implementa tion are still not in place. This creates significant uncertainty for 
economic operators. Could China inform the Committee when implementing measures will be 
adopted? The EU requests that China notifies draft measures concerning any sectoral 
implementation  to the TBT Committee in order to give adequate opportunity for WTO Members and 
their stakeholders to comment on any subsequent developments.  
1.395.   The delegation of the United States  provided the following statement. The United States 
remains very concerned abo ut China's suite of cybersecurity and cryptography measures. As we 
have said in prior TBT Committee meetings, this is a major concern for U S companies, given China's 
intertwined requirements for conformity assessment systems for security testing, technical  
regulations, and a multi -level classification scheme laying out requirements including mandatory 
standards and testing for the purchase of ICT goods across a wide range of commercial sectors. 
China's Cybersecurity Law entered into force on 1 June 2017, in  spite of serious and long -standing 
concerns from the United States and many other international stakeholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
sometime general in scope, and sometimes sector -specific.  
1.396.   We have many concerns regarding China's Cybersecurity Law and related measures, which 
impose far -reaching, highly trade -restrictive conditions on foreign ICT products through "secure and 
controllable " requirements, enforced by c ybersecurity review regime checks. Such requirements are 
largely based on a planned update and expansion of the Ministry of Public Security's M LPS. As one 
example, China's 25 January 2018 draft measure, "Information Security Technology – Guidelines for 
Grading of Classified Cybersecurity Protection, " appears to repeat and elaborate upon China's MLPS. 
The United States and other Members at prior Committee meetings have laid out numerous other 
 
72 For previous statements follow the thread under IMS ID  526 (under dates raised and references) . G/TBT/M/81  
 
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  concerns in prior interventions. Additionally, t he United States reiterates its serious concerns 
regarding China's Office of State Commercial Cryptography (OSCCA) draft Cryptography Law of the 
People's Republic of China and submitted comments to China in May 2017. The United States is 
concerned that thi s law would codify potentially far -reaching, highly trade -restrictive cryptography -
related constraints on foreign ICT products. Because these issues are technically complex and 
China's approach appears to be both novel and would have a potentially widespre ad impact in the 
commercial sector, the United States requests that China undertake in -depth consultations with the 
US Government, other WTO Members, and global stakeholders.  
1.397.   We also request that China afford subsequent opportunities for interested parties  to submit 
comments on revised iterations of draft standards and all other implementing measures related to 
the Cybersecurity Law. Given the broad potential impact of these standards and measures and the 
serious concerns they have raised, it is critical th at China act deliberately to collaborate with all 
interested parties, and take their comments into account before adopting the drafts as written. We 
will continue to carefully monitor China's implementation of the Cybersecurity law and related 
measures, as  well as movement on the draft Cryptography Law. We look forward to continuing this 
important dialogue with you.  
1.398.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding China's "Cybersecurity Law " and would like  to refer to the previous statement we made 
at the last TBT Committee in February 2020. Japan is concerned with related enforcement regulation 
as well. Japan would like to request that China provide notification of the enforcement regulations 
to the TBT Co mmittee and consider comments from stakeholders. In addition, Japan would like to 
request that China provide adequate lead time from completion of these regulations until their 
enforcement, and to implement these measures in a transparent manner.  
1.399.   The deleg ation of Canada  provided the following statement. Canada wishes to reiterate the 
same statement made by Canada on the other related STC to China's cybersecurity measures 
namely Cyberspace Administration of China – Draft implementing measures for the Cybers ecurity 
Review of Network Products and Services ( STC ID 533).  
1.400.   The delegation of Australia  provided the following statement. Australia reiterates our 
previous position regarding China's Cyber Security Law and related laws, including the Provisions on 
Intern et Security Supervision and Inspection by Public Security Organs. Australia respectfully 
reiterates our concerns that many details about the Cyber security Law remain unclear. Australia 
notes that, consistent with the TBT Agreement, the measures should be i mplemented in a non -
discriminatory manner and in a way that is no more trade restrictive than necessary. Australia urges 
China to consider less trade -restrictive alternative measures that are reasonably available to achieve 
its objectives. Australia notes the entry into force of China's Cryptography Law on 1 January 2020, 
and would value on -going  discussion with China on implementation of the Cryptography Law and 
other related cyber laws.  
1.401.   In response, the delegation of China  provided the following statement . The drafting and 
implementation of Cyber security Law have fully drawn on common international practices ; the 
purpose of the law is to safeguard national sovereignty in cyber space, national security and public 
interests, to protect the rights and interes ts of the citizens, the legal persons and other organizations 
in China. It is also conducive to the application of information technology and the development of 
the great potential of the Internet. While it is by no means to restrict the market access of f oreign 
enterprises, technologies and products in China, nor to restrain the orderly free flow of the data in 
accordance with the law. Unlike China's practice ，we noticed that some Members' cybersecurity 
regulation and risk assessment criteria determine the risk of the vendor in accordance with its 
ownership and operating location. This approach has constituted de facto , non-necessary restriction 
to the market access of products produced by foreign enterprises, which violated the non -
discriminatory principles  of WTO.  
1.3.36   European Union – Regulation (EC) No 1272/2008 (CLP Regulation) ( IMS ID 53973) 
1.402.   The delegation of the Russian Federation  provided the following statement. The Russian 
Federation would like to thank the EU for its active work on the gastric fluid bioe lution protocol (i.e. 
 
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  EURL ECVAM submission to OECD) and its commitment to incorporate it into the Article 12 of the 
CLP Regulation (i.e. DG Envi and DG Grow now convening a bioelution expert group under CARACAL 
to discuss the incorporation of bioelution t est data into regulations). We do believe that this approach 
will be helpful in limiting the negative impact of the current unjustified classification of the cobalt 
metal on a wide range of cobalt -containing products. At the same time, the Commission has f ailed 
to adopt bioelution at the level of OECD. In this regard, application of bioelution and mitigating the 
negative consequences of such a strict classification of cobalt on alloys and compounds appear to 
be problematic. Therefore, the measure at issue s eems to be more trade restrictive than necessary 
and will have the negative impact on manufacturing and trade in a wide range of cobalt -containing 
products upstream and downstream as well as distort the global value added chains.  
1.403.   The 14th adaptation to tec hnical progress (ATP)  was adopted on 18 February 2020 and 
applies from 1 October 2021. The European Commission rushed this classification without full 
scientific justification and necessary assessment of its economic consequences, ignoring the 
comments mad e by the WTO Members and even disregarding deep concerns raised by the member 
States of the EU itself. Moreover, the Commission has chosen to ignore the concerns of the global 
and even its own European industries, which are involved in manufacturing, use, and disposal of the 
products containing cobalt and titanium dioxide. In this regard, the 14th ATP is yet another example 
of a highly inappropriate implementation of the CLP Regulation by the Commission as it contradicts 
the Commission's own communication o n the precautionary principle's application. In accordance 
with COM (2000) 1, section 6.1, item 16 (I quote) "the implementation of the approach based on 
the precautionary principle should begin with a scientific evaluation, as complete as possible, and 
where possible, identifying at each stage the degree of scientific uncertainty " (the end of the quote). 
Indeed, the precautionary principle should be applied in cases where it is not possible to complete a 
comprehensive risk assessment because there is no su fficient data, and where the regulator 
therefore makes conservative assumptions about potential hazards of certain chemical. 
Nevertheless, the precautionary principle can still only be invoked once a full scientific assessment 
has been made. In the case of  cobalt classification, the Commission admits that it has not made a 
full scientific assessment, as there has been absence of complete scientific data (e.g. oral 
carcinogenicity study considered together with existing epidemiological data), therefore under  the 
circumstances, any scientific assessment is simply impossible. As a result, the current classification 
of cobalt for all routes of exposure is not based on a complete set of scientific facts, and has been 
adopted in direct contradiction to the Commiss ion's own guidelines on the proper application of the 
precautionary principle. We note hereby that the provisions of the Agreement on TBT explicitly 
require scientific justification when elaborating, adopting, and applying technical regulations.  
1.404.   The statem ent of the Commission that any negative consequences will be largely mitigated 
by the application of the Generic Concentration Limit (GCL) of 0 .1 % is factually incorrect. Firstly, 
the average content of cobalt impurity in stainless steel is several times higher than that and even 
in some cases of carbon steel and some alloys, can still be problematic. Secondly, the current GCL 
of 0.1 % is being set temporarily only and if it is to be revised in favo ur of the initially proposed 
Specific Concentration Limit,  which was even more stringent than the current GCL by an order of 
magnitude, the consequences would be even more dire. Moreover, the Commission further admits 
that the methodology behind the derivation of the concentration limits (I quote) "was considered 
questionable " (the end of the quote). Besides, the EU notified to the WTO the draft regulation 
amending Annex XVII to REACH Regulation ( G/TBT/N/EU/714) . According to the document, cobalt 
metal was included in the list of CMR category 1 B in order to prevent contacts of t he general 
population with it. We note hereby that the draft legislation does not provide any exemption and 
steel articles will be covered by these restrictions as the Commission was not able to adopt the 
gastric bioelution protocol at the OECD, which resu lted in it remaining in uncertainty.  
1.405.   As for economic implications, the adopted cobalt classification will have a significant negative 
impact on manufacturing, supplying, and recycling of a wide range of products. Apart from cobalt 
itself, this non -scientif ic classification directly affects the markets for copper, nickel, alloys, steel, 
and stainless steel, as these materials contain traces of cobalt. In practical terms, it also makes it 
impossible to recycle these materials efficiently, which renders ineffe ctive the EU own policies on 
resource efficiency, energy efficiency, recycling, circular economy, and reduction of waste. The 
examples of the negative implications of this classification are numerous and they have been 
provided within the meetings of the C ommittee on TBT and the Council for Trade in Goods as well 
as bilaterally by Russia and the industry itself, including the Cobalt and Nickel institutes. However 
all the presented data have never been considered, nor taken into account, nor even commented 
on. Basically, data have remained ignored and concerns have remained not addressed.  G/TBT/M/81  
 
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  1.406.   We urge the EU to revoke the measure and rely on available scientific data and arguments 
made by Russia and European and global industries. Currently it is possible to class ify cobalt as 
carcinogen for inhalation route of exposure only. It is necessary to anticipate the results of the study 
initiated by the Cobalt Institute on carcinogenicity of cobalt for oral route of exposure, not to classify 
cobalt for all routes of expos ure by default, not to create unnecessary obstacles to trade that have 
a potential to distort global supply of a wide range of products and creation of global value added 
chains, to postpone amendments to REACH until the issue with bioelution is solved in the EU and 
the relevant scientific information on carcinogenicity of cobalt is available. Russia stresses that 
bioelution protocol has been blocked and it makes impossible for the EU to mitigate the vast majority 
of the negative consequences of the current  classification of cobalt, including those directly distorting 
international trade.  
1.407.   The delegation of Brazil  provided the following statement. Brazil would like to support this 
STC raised by Russian Federation. In the 14th review of ATP for Regulation (EC)  No 1272/2008, the 
reclassification of cobalt as a carcinogenic level 1B was approved. The classification of cobalt as a 
carcinogenic product generates a great potential negative impact on nickel production in Brazil, since 
cobalt is also found in trace am ounts within nickel production. Restrictions on the commercialization 
of cobalt would therefore negatively impact nickel production in Brazil. Brazil is the primary nickel 
producing country in South America, exporting around 70 thousand ton nes of nickel, a ccording to 
2017 figures. According to industry estimates for the same year, the total value of nickel production 
reaches US D 12,350 million. Around 56% of the nickel mine production in Brazil is at risk with 
limitations on the trade of cobalt. In light of  this concern, we kindly ask the EU to consider revising 
restrictions on the use of cobalt, while relying on sound scientific analyses to support its technical 
regulations with significant impact on trade.  
1.408.   The delegation of Australia  provided the following  statement. As previously noted in this 
Committee, Australia recogni zes the E U's right to regulate for public and occupational health and 
safety. We also recogni ze that appropriate classification and labelling for hazardous substances and 
mixtures can addr ess legitimate public and occupational health concerns. However, Australia and 
other WTO Members have raised concerns on multiple occasions in this and other for a that these 
measures are more trade  restrictive than necessary. Our concerns have focused on t he potential of 
these regulations to create unnecessary obstacles to international trade in products containing 
titanium dioxide and cobalt, as well as the raw materials themselves. While the EU has provided 
some information on the downstream consequences for TiO2, we have yet to receive a clear response 
to our concerns regarding products containing trace amounts of cobalt. Despite concerns raised by 
Australia and other Members, the EU has retained the classification of cobalt as a carcinogen through 
all routes of exposure, rather than limiting the classification to inhalation only. This means a larger 
number of products are potentially affected by the regulation, and there is therefore a greater risk 
of unintended downstream consequences. For example, stain less steel is a common product which 
may contain trace amounts of cobalt in concentrations greater than the generic limit of 0.1 % applied 
in the regulation. We continue to urge the EU to ensure that regulations to address concerns about 
the possible hazard s associated with TiO2 and cobalt are no more trade restrictive than necessary.  
1.409.   In response, the delegation of the European Union  provided the following statement. Thank 
you to the delegation of Russia for its comments on the classification of cobalt inclu ded in the 14th 
ATP of the Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances 
and mixtures (CLP Regulation). After its adoption by the Commission, the Commission Delegated 
Regulation was sent to the Council and the Eu ropean Parliament. These two EU institutions did not 
object to the measure and the motion for a resolution tabled by the European Conservatives and 
Reformists was rejected by the European Parliament. Thus, the Commission Regulation was 
published in the Off icial Journal of the EU in the beginning of 2020 and the classification of cobalt 
will become applicable as of 1 October 2021. We would like to reiterate that, in line with the UN GHS 
(UN Globally Harmonized System of Classification and Labelling of Chemic als), the classification of 
any substance is based on a hazard assessment and not on risk assessment.  
1.410.   With regard to the classification of cobalt for all routes of exposure, the Commission would 
like to confirm that it is in line with the UN GHS. UN GHS st ipulates the following in Table 3.6.2: 
"state route of exposure if it is conclusively proven that no other routes of exposure cause the 
hazard ". In the case of cobalt, such evidence was not available and a potential re -examination of 
the classification as regards routes of exposure can only be considered if new and relevant data from 
scientific studies, demonstrating absence of carcinogenic effects from oral or dermal routes of 
exposure, become available. In fact, the Commission services have already been i nformed of the G/TBT/M/81  
 
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  industry plans to conduct an oral carcinogenicity test for cobalt under REACH, so that new evidence 
can be generated. In any case, in view of the time needed for such test results to become available, 
there was no scientific and legal justif ication at this point in time to exclude the oral route. In case 
new scientific information becomes available in the future, an amendment could only be envisaged 
following a revised Risk Assessment Committee (RAC) opinion.  
1.411.   It should also be noted that clas sification under CLP is based only on the scientific 
assessment of the hazards derived from the intrinsic properties of a substance and not on its uses, 
while potential downstream legal or socio -economic considerations are not part of the principles for 
hazard classification. Nevertheless, the classification under the CLP Regulation does not in itself 
restrict the placing on the market of cobalt or cobalt -containing products. When a substance is 
subject to harmoni zed classification, only labelling and packa ging obligations are triggered for that 
substance and any mixture containing it, but not for articles (e.g. cutlery or other stainless steel 
articles). Moreover, it should be taken into account that the Commission considered that the method 
used to determi ne the Specific Concentration Limit of 0.01% should be assessed in order to discuss 
if the method is relevant for inorganic compounds like cobalt. The entry in Annex VI to CLP for cobalt 
is without such specific limit and the generic limit of 0.1% will the refore be applied.  
1.412.   Finally, with regard to the transparency of the adoption procedure, the Commission would 
first like to point out that all comments sent to the TBT Committee by WTO Members were distributed 
to member States and they were duly taken into a ccount by the Commission and member States in 
the decision -making process. Moreover, ECHA's RAC committee took into account in its scientific 
assessment all available data, including the information submitted during the public consultation 
period. As far a s information on meetings of the REACH Committee is concerned, it should be noted 
that REACH Committee discussions and documents submitted to it are confidential since it is a 
comitology committee, unless access to documents is granted pursuant to Regulati on (EC) No 
1049/2001. On the other hand, since 2019 the ATPs of the CLP Regulation are discussed in meetings 
of the CARACAL expert group, in the framework of which all documents and position papers on CLP 
are made publicly available.  
1.3.37   China – Catalogue of Solid Wastes Forbidden to Import into China, 
G/TBT/N/CHN/1211 , G/TBT/N/CHN/1212 , G/TBT/N/CHN/1223 , G/TBT/N/CHN/1224  
(IMS ID 54574) 
1.413.   The del egation of the United States  provided the following statement. The United States 
would like to reiterate its concerns, as expressed during our last meeting in February 2020, regarding 
the negative trade and environmental impacts resulting from China's impo rt ban, and accompanying 
measures, on certain recovered materials. China has made certain references to environmental 
concerns and has invoked an objective of environmental protection as the rationale for the measures. 
Yet, China has provided no details as  to what specific environmental concerns it is hoping to address, 
much less how these restrictive measures – including a full ban – are intended to alleviate any such 
environmental concerns. China's current approach appears to have the opposite effect. The  most 
likely outcome of the ban is that reusable materials will be redirected from productive purposes, 
such as recycling, to the waste stream.  
1.414.   We have repeatedly requested meetings with experts from China's Ministry of Ecology and 
Environment (MEE) to und erstand the environmental concerns China has and why these measures 
are necessary to address those concerns, and to work cooperatively to ensure that valid 
environmental concerns are met in the least trade -restrictive manner possible. China has declined 
all such requests. Instead of attempting to explain its environmental objectives and working 
constructively to minimize trade restrictions, China moved forward with the implementation of these 
measures and even expanded the scope of restricted materials. In July 2018, and again in July and 
December 2019, China released draft revisions to the Law on Prevention and Control of 
Environmental Pollution by Solid Wastes. As currently written, this draft Law appears to ban the 
import of all recyclable materials into China. The United States is very concerned with the overly 
broad scope of "solid waste ", which can effectively result in an import ban on recyclable materials. 
The United States is also concerned with what appear to be possible different requirements for 
foreign and domestic commodities.  
 
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  1.415.   Recyclable materials ( i) have been separated from the waste stream for recycling as a raw 
material and ( ii) are saleable items traded within a distinct global marketplace (i.e., they have an 
underlying economic value). Thes e qualities make the classification of recyclable materials as 
"waste " inaccurate. The United States urges China to provide clarification and more precisely define 
and distinguish recyclable materials and scrap from "waste " in its laws and measures. Additi onally, 
these policy measures appear to be contrary to the pro -circular economy narrative that China is 
promoting in the WTO as well as internationally.  Specifically, a resource -efficient circular economy 
requires supply chains to work in reverse, channell ing end-of-life products toward s recycling. It is 
this process of recycling – from collection to recycling into scrap materials and finally manufactured 
into recycled commodities – that closes the loop on waste and creates a "circular economy ". The 
product s and intermediaries that move along the reverse supply chain must be sourced from a 
diffuse customer base and thus need trade policies that facilitate rather than impede their 
movement. However, as the world's largest processor of scrap materials, these m easures hinder 
China's aspirations to transition to a more resource -efficient, global circular economy by directly 
impacting global recycling networks with its effective ban.  
1.416.   While China has asserted that it is up to the importing countries to adjust their  domestic 
recycling processes to meet China's import parameters, the United States would like to underscore 
that for a vast number of materials outlined in China's ban and import control standards, China has 
no mandatory commensurate domestic standard in p lace. Also concerning is the lack of notification 
of new measures related to the trade in scrap materials, including providing a reasonable interval 
for notice and comment between adoption, implementation, and entry into force of the final 
measure. We reit erate our request that China immediately halt implementation of its ban and revise 
the relevant measures in a manner consistent with existing international standards for trade in scrap 
materials, which provide a global framework for transparent and environ mentally sound trade in 
recycled commodities.  
1.417.   The delegation of New Zealand  provided the following statement. New Zealand 
acknowledges and supports the right of all WTO Members to regulate to achieve legitimate domestic 
health and environmental objectives.  New Zealand applauds China's stated proactive policy 
objectives in relation to sustainable development, and encourages valid actions to limit harmful 
environmental impacts from contaminated waste inside its borders. New Zealand in no way seeks 
to question  China's right to regulate to protect its environment. However, New Zealand remains 
concerned that vanadium slag is included in China's catalogue of banned imports under this measure. 
We reiterate our view that vanadium slag is a purposefully produced co -product with a purposeful 
end use in production of specific forms of steel. It is not a waste product, and so should not fall 
under measures for solid waste. New Zealand recalls that China itself is the largest global producer 
of vanadium slag, with approxi mately 500,000 tonnes annual production generated as a co -product 
from steel mills.  
1.418.   New Zealand would appreciate clarification on how China has ensured that the rules that 
apply to foreign products are no less favourable than those accorded to domestic pro ducts. We would 
be interested also to hear a further explanation from China on how it has ensured that the import 
ban on vanadium slag is not more trade restrictive than necessary to achieve China's environmental 
and health protection objectives. New Zeala nd thanks China for the recent discussion on this issue, 
and looks forward to further constructive engagement on this topic to better understand China's 
approach to distinguishing between waste and non -waste materials.  
1.419.   The delegation of Canada  provided the  following statement. Canada supports China's 
willingness to protect the environment, including by limiting harmful impacts resulting from 
contaminated waste material. However, we want to raise concerns over the inclusion of wood pellets 
on the list of ban ned products. Canadian wood pellets are not contaminated. They are made from 
pure forest fibre, such as logging residuals (small diameter stems and branches) and residues 
(sawdust) from logs being converted into lumber in sawmills. Wood pellets are benefic ial for the 
environment and can contribute to China's goal of enhancing environmental protections. Wood 
pellets are a renewable, low -carbon resource and switching from coal to wood pellets reduces GHG 
emissions significantly. In this context, we ask China how it has ensured that its ban on wood pellets 
is not more trade restrictive than necessary to meet China's environmental and hea lth protection 
objectives. We urge China to consider other mechanisms to address the very specific problem of 
contaminated mat erials, while ensuring that mutually beneficial trade can continue in a predictable 
manner and fulfilling environmental protection goals.  G/TBT/M/81  
 
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  1.420.   In response, the delegation of China  provided the following statement. China has been 
pushing for ecological progress,  pro-actively practi sing the values of "sustainable development" and 
"green development" in order to meet the Chinese people's ever -growing need for a beautiful eco -
environment and aiming to solve significant outstanding environmental problems. Advancing t he 
reform of the solid wastes import administration regime is one of the most important steps that the 
Chinese government has taken to implement the New Development Ideas and to safeguard the eco -
environment safety and people's health. In accordance with i nternationally recognized principles, 
each Member has the obligation to handle and dispose of the wastes it has generated on its own. 
China, as a developing Member with the largest population, must make the inevitable choice of 
restricting and prohibiting imports of solid wastes while improving its own domestic solid wastes 
treatment and disposal. Current scientific studies indicate that the residues resulting from the 
recycling and disposal of solid wastes and their carried wastes may pose various risks to  human, 
animal, and plant life and health, as well as to the environment. Since solid wastes have already 
significantly increased the burden on China's eco -environment and had huge negative impacts on 
human, animal, and plant life and health, China conside rs that merely reforming the domestic 
regulation of solid wastes would not be sufficient for achieving our purpose of safeguarding the 
ecological safety and population health to the maximum extent possible.  
1.421.   In the process of adjusting the relevant policies , the Chinese government has adequately 
taken into account voices at home and abroad, and adjusted the Import Waste Management 
Catalogue in different batches. China has also set a sufficient transition period for the relevant 
industries and has fulfilled o ur transparency obligations under the WTO rules. Meanwhile, China 
allows solid wastes processed into raw materials that meet the relevant national quality standards 
to enter the country by trade. Over the past decades, enterprises from other WTO Members ha ve 
exported large quantities of solid wastes to China and derived huge financial gains. We earnestly 
hope that these Members could also actively fulfil their international social responsibility and make 
contributions to global environmental protection. At present, not only China, but also every Member 
should follow the fundamental principle of disposal and absorbing the wastes it has generated on its 
own. Only on the basis of this principle can we reach a better consensus on managing solid waste 
pollution and search for a solution to this problem. At the same time, abiding by this principle will 
also contribute to the promotion of the global green low -carbon circular development, and the 
creation of a clean and beautiful world.  
1.422.   First of all, China still allows the trade of raw material processed from solid wastes which 
meet China's quality and safety standards. Second, over the past decades, enterprises fr om some 
WTO Members have exported large quantities of harmful solid wastes to China and derived huge 
financial gains. Third, scientific studies indicate that the residues resulting from the recycling and 
disposal of solid wastes and their carried wastes ma y pose various risks to human, animal, and plant 
life and health, as well as to the environment. Fourth, in accordance with internationally recognized 
principles, each Member has the obligation to handle and dispose of the wastes it has generated on 
its ow n. At present, every Member, not only China, should follow this fundamental . Only on the basis 
of this principle can we reach a consensus on managing solid waste pollution and find a solution to 
this problem. Last, we earnestly urge the Members especially those who are still exporting harmful 
solid wastes could also actively fulfil their international social responsibility and make contributions 
to the global environmental protection.  
1.3.38   Viet Nam – Cybersecurity Measures ( IMS ID 54475) 
1.423.   The delegation of the United States  provided the following statement. We are deeply 
concerned with Viet  Nam's Law on Cybersecurity. We are also disappointed that Viet  Nam failed to 
notify the Law to the WTO for a formal notification and comment period while it was still in draft 
form. We urge Viet  Nam to immediately notify the Law and the draft implementing measures that 
were published on 2 November 2018 to allow all interested parties to provide input. We also urge 
the Government of Viet  Nam to carefully review and consider stakeh older comments when finalizing 
these measures. We also urge the Government of Viet  Nam to work with the US  and other 
stakeholders to resolve concerns with the Law on Cybersecurity and its implementing decree. We 
encourage Viet  Nam to consider using a risk -based approach to cybersecurity that draws from 
industry best practices, widely accepted definitions, and international standards. We request that 
 
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  you consider the Common Criteria Recognition Arrangement (CCRA) certification process when 
finalizing the dra ft implementing measures for the Law.  
1.424.   The delegation of the European Union  provided the following statement.  The European Union 
shares the Member's concerns on the Vietnamese Cyber security law, which applies as of 1 January 
2019, and expresses concern as r egards the potential economic impact of this legislation and the 
compatibility with Viet  Nam's commitments under the WTO. The European Union would like to have 
an update on the adoption of the draft Implementing Decree on Cybersecurity. The European Union 
hopes that the Vietnamese Government will seriously consider the concerns expressed by the 
European Union on the Decree and will continue the dialogue with us to ensure it aligns to 
international best practices. We would also appreciate obtaining some indi cations on the intentions 
of the Vietnamese Government as regards further implementing measures and on the plans for 
taking into consideration comments from interested parties, including industry and stakeholders. 
The European Union kindly requests that Vi et Nam notifies the draft Implementing Decree, as well 
as any other planned implementing measures, to the TBT Committee in accordance with Article 2.9 
of the TBT Agreement, so that WTO Members can provide comments within a reasonable time limit. 
The Europe an Union encourages Viet  Nam to develop and implement the Cyber security law and any 
implementing measures in full respect of WTO principles, such as non -discrimination and 
proportionality and to take into consideration available international standards and  best practices.  
1.425.   The delegation of Canada  provided the following statement. Canada recognizes the 
importance of cybersecurity and appropriate measures to preserve it, and appreciates the efforts 
Viet Nam is undertaking to perfect the measures implementing its Cybersecurity Law. Nonetheless, 
Canada continues to have concerns regarding the compatibility of Viet  Nam's measures with its WTO 
commitments. In line with our previous statements, Canada continues to seek: Viet  Nam's 
recognition that, as currently dra fted, the law and implementing decree could have very extensive 
product coverage; notification of the law and implementing decree to the TBT Committee; the use 
of international standards and conformity assessment frameworks including the C CRA certification  
process; and clarification that this matter does not apply to the private sector. Could Viet  Nam please 
update the Committee on the status of the implementing decree and what steps it plans to take 
next?  
1.426.   The delegation of Australia  provided the following statement. Australia supports the concerns 
raised by others on this measure and reiterates its previous statement in the TBT Committee. 
Australia welcomes an update from Viet Nam in relation to the draft Decree being considered for 
adoption, and next steps . 
1.427.   In response, the delegation of Viet Nam  provided the following statement. The Vietnamese 
Law on Cybersecurity and the draft Decree for implementing certain articles of this Cybersecurity 
Law have not regulated technical requirements with regard to inform ation technology products or 
equipment. The process through which the Law and its draft Decree were formulated and/or to be 
enacted has been very open, transparent and fully complies with requirements prescribed in the Law 
on promulgation of legal document s in Viet Nam. In fact, Viet Nam published all draft legislation in 
this subject matter on respective government portals to enable all individuals, organizations, 
domestic and foreign stakeholders to access and provide comments. The draft Decree for 
implem enting certain articles of this Cybersecurity Law has been amended and supplemented to be 
flexible, suitable to reality, and creates the most favourable conditions for foreign enterprises 
operating in Viet  Nam, without hindering the development of the Digi tal Economy. It is currently 
being reviewed for approval by the Prime Minister.  
1.3.39   European Union – Amendments to the Directive 2009/28/EC, Renewable Energy 
Directive ( IMS ID 55376) 
1.428.   The delegation of Colombia  provided the following statement. Colombia wishes to reiterate 
its ongoing concern regarding Directive (EU) 2018/2001 of the European Parliament and of the 
Council, which establishes that, as from 2021, first generation biofuels shall account for a share of 
no more than 7 % in the transport sector, and that first generation biofuels posing a high risk of 
indirect land use change (ILUC) shall have their contribution to the renewable energy share gradually 
reduced to 0 % by 2030.  In Colombia's view, these prov isions are inconsistent with the national 
treatment and MFN  obligations set out in the GATT  1994 and Article 2.1 and 2.2 of the WTO TBT 
 
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  Agreement.  We therefore reaffirm the arguments that have been presented at the TBT Committee 
meetings concerning this ma tter, which appear in document G/TBT/W/714  dated 2  March  2020.  
Colombia once again requests the EU to conduct a thorough review of the delegated act in 2021, in 
order to adopt an approach that enables sustainable palm oil to contribute to the EU's renewable 
energy targets.  We once again we lcome the opportunity to comment on this matter and request the 
EU to clarify how it reconciles this discriminatory treatment against palm oil producing countries with 
its WTO  obligations concerning national and MFN treatment. We look forward to the EU's r esponse 
to the concerns raised.  
1.429.   The delegation of Malaysia  provided the following statement. Malaysia regrets having to 
continue raising our concern on the Directive (EU) 2018/2001 of the European Parliament and of the 
Council of 11 December 2018 on the pr omotion of the use of energy from renewable sources and 
the Commission Delegated Regulation (EU) 2019/807 of 13 March 2019 which have negatively 
impacted the oil palm industry and Malaysia's trade interest. The European Union continues to 
reiterate that th e legislation does not represent an import prohibition of biofuels and bioliquids 
produced from palm oil. However, this is tantamount to a barrier and de facto  ban of the use of palm 
oil as feedstock for the production of biofuels and bioliquids for use in  the European Union. The 
development of such regulation has negatively impacted the oil palm industry and Malaysia's trade 
interest. This has resulted in several countries to enforce legislation to discriminate biodiesel 
produced from palm oil against biod iesel produced from other vegetable oils in terms of fiscal 
incentives without substantiated by scientific evidence.  
1.430.   The measure is believe d to have culminated into a technical barrier to trade that distorts the 
market and pricing system. This is a measure  which is against the principle of free trade that is 
unfavourable to palm oil. We remain troubled as this creates the arbitrary or unjustifiable 
discrimination disguised restriction on international trading of palm oil and its products. This is taking 
into consideration that the delegated regulation creates unnecessary obstacles which are more trade 
restrictive than necessary and more burdensome for producers of palm oil -based biofuels and 
bioliquids including Malaysia. We have been engaging with the Europ ean Union in all possible fora 
to provide scientific evidence, facts and information as well as to exchange views to find a mutually 
beneficial and mutually acceptable way forward to ensure continued market access for Malaysian 
palm biodiesel.  
1.431.   Although we appreciate the European Union for their willingness for open discussion and 
dialogue, the continuous engagements have not translated in a fair treatment for palm oil produced 
in Malaysia. We urge the European Union to observe the principles of fairness, ju stice, openness, 
transparency and non -discrimination in conducting international trade. We also urge the European 
Union to provide an equitable treatment across all oil crops biofuels and bioliquids in line with the 
principle of non -discrimination which st ipulates that a Member shall not discriminate between "like" 
products from different trading partners. Malaysia is committed to realising the 2030 Agenda for 
Sustainable Development and its 17 Sustainable Development Goals. The Sustainable Development 
Goals are a universal call to action to end poverty, protect the planet and ensure that all people 
enjoy peace and prosperity. In this context, the oil palm industry plays a very important role in 
contributing positively and constructively towards achieving th e Sustainable Development Goals.  
1.432.   Apart from that, in March 2019, the Government of Malaysia had agreed with the new policy 
in ensuring that Malaysian oil palm is cultivated in a sustainable manner. The measures included to 
cap oil palm cultivated area to 6 .5 million hectares; to put a stop on conversion of permanent forest 
reserved area; to halt planting of oil palm in the new peatland area and further strengthen 
regulations with regard to existing oil palm cultivated on peat; and to make available oil palm  
plantation maps for public access that demonstrate further transparency in the supply chain. 
Malaysia wishes to emphasi ze that the Malaysian oil palm industry is committed to produce palm oil 
in accordance with sustainable principles and criteria under th e Malaysian Sustainable Palm Oil 
(MSPO) certification scheme, which has been implemented on a mandatory basis since 1 January 
2020.  
1.433.   Malaysia reiterates its commitment made at the Rio Summit in 1992 to retain at least 50% 
of the land area under forest cover  and has put in place policy framework and legislation to ensure 
sustainable development balancing the protection of the environment and socio -economic  
development. This is evident through the implementation of various programmes and initiatives for 
conser vation and preservation of forests and biodiversity including among others : G/TBT/M/81  
 
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  a. The Central Forest Spine covers 5.3 million hectares in Peninsular Malaysia and the Heart 
of Borneo is a trilateral cooperation between Brunei, Indonesia and Malaysia covering an 
area of over 20 million hectares. These initiatives help to strengthen the world's resilience 
to climate change by conserving carbon sinks and creating a huge green lung for the world 
while at the same time protecting the livelihoods for the forest dependen t communities;  
b. A survey project that aims to undertake a new population survey of the orang -outan and 
pygmy elephants in Sabah. This survey will bring together wildlife experts, scientists and 
researchers to take part in an extensive study on the populatio n of the state's iconic 
wildlife; and  
c. Replanting of one million forest tree species within the next 10 years particularly in 
degraded lands as well as protecting the wildlife population which the projects will be 
sponsored primarily by the palm oil industry players. On the other hand, Malaysia is now 
in the midst of setting up a specific fund for green initiatives, especially for tree planting 
and wildlife conservation.  
1.434.   We urge the European Union to acknowledge and recogni ze the efforts and commitmen t in 
sustainable production of Malaysian palm oil as well as our contributing towards protection and 
conservation of forest and biodiversity. We remain fully open and committed to negotiating in a 
sincere and constructive manner in ensuring a non -discrimin atory treatment against palm products 
and to prevent the unnecessary barrier for market access of palm products into the European Union. 
Malaysia will continue to monitor the development and we look forward to the response from the 
European Union.  
1.435.   The dele gation of Ecuador  provided the following statement. We wish to refer Members to  
documents G/TBT/W/650  and G/TBT/W/718 , which contain the statements made by Ecua dor on this 
matter during the meetings of this Committee held in June and November  2019 and in 
February  2020.  My delegation is compelled to reiterate its concern regarding this European Union 
(EU) regulation and the methodology for calculating indirect lan d use change (ILUC) upon which it 
is based, which lacks solid scientific grounds.  The EU claims that this regulation is not a ban on the 
import of palm oil or palm oil based biofuels. However, even if there is no explicit ban, the regulation 
is designed in  such a way that there effectively is one.  On the one hand, it leads to arbitrary 
discrimination between like biofuels, some of which are produced from crops such as rapeseed and 
sunflower that are less productive per hectare than oil palm, yet are not con sidered to present a 
high ILUC risk. This could be inconsistent with obligations under Article 2.1 of the TBT Agreement 
and Article I:1 of the GATT  1994.  On the other hand, it favours the use of raw materials of European 
origin, which would violate the pri nciple of national treatment contained in Article 2.1 of the TBT 
Agreement and Article III:4 of the GATT  1994.  Any environmental measure for fulfilling the European 
climate agenda must be compatible with the multilateral trading system. In other words, the  
measure must not constitute a means of arbitrary or unjustifiable discrimination, or a disguised 
restriction on international trade.  
1.436.   The delegation of Guatemala  provided the following statement. We would like to thank 
Colombia for including this item on t he agenda. The systemic concern regarding this measure has 
been noted and will be followed up accordingly.  
1.437.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks various Members for raising this issue.  The European Union notes that the 
issue of amendments to the EU Renewable Energy Directive is now subject to WTO dispute 
settlement proceedings, notably under DS593 ( EU – Certain measures concerning palm oil and oil 
palm-based biofuels ). In order to prese rve the integrity of such proceedings, the European Union 
will defer all discussions to that forum and accordingly refrain from discussing this matter in this 
Committee.  G/TBT/M/81  
 
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  1.3.40   Thailand – Certificate of Analysis for the import of alcoholic beverages , 
G/TBT/N/THA/524 , G/TBT/N/THA/548 , G/TBT/N/THA/549  (IMS ID 55677) 
1.438.   The delegation of the European Union  provided the following statement. The European Union 
would like to thank Thailand for the reply of 24 April 2020 to the comments submitted in December 
2019 as regards the notifications G/TBT/N/THA/548  and G/TBT/N/THA/ 549 notified on 18 Jun e 2019. 
The European Union welcomes the information concerning the consultation with stakeholders and 
the meetings held with embassies, including the delegation of the EU in Thailand, prior to the entry 
into force of the concerned regulations. However, suc h public consultation does not preclude 
Thailand from the obligation to notify the draft regulations to the TBT Committee at an early 
appropriate stage providing a reasonable commenting period to the Members in line with Articles 
2.9.2 and 2.9.4 of the TBT  Agreement. The European Union understands that Thailand recogni zes 
OIV methods of analysis as "equivalent test methods" for Wine and Sparkling wine made from grapes 
and fermented liquor insofar as the issuing authority can confirm that the amounts of subs tances in 
the products do not exceed the limits set by the Excise Department. If it is not the case, the importer 
shall submit samples of the wine to the Excise Department laboratory, a Government laboratory or 
a private accredited laboratory in Thailand. The same reasoning applies for the acceptance of the 
"EU wine export certificate " in order to show compliance with the new Thai standards. As for the 
recognition of other "equivalent test methods ", the European Union would like to seek further 
clarificatio n regarding the principles applied by Thailand for the acceptance of test methods 
accredited according to the ISO/IEC 17025 standards.  
1.439.   The European Union fully concurs with Thai authorities in the protection of consumer health 
as the main driver for the es tablishment of maximum level of substances for liquors. In this respect, 
the European Union reiterates the recommendation to adopt scientifically based international 
standards and test methods such as, for wine, those of the International Organisation of V ine and 
Wine (OIV) that protect consumers' health while avoiding unjustified trade barriers. In particular, 
we would highlight the specific burden that the analysis of non -typical parameters would represent 
for small export volumes. The European Union reit erates its willingness to work with Thailand on the 
review of the Thai standards with the objective of ensuring their alignment with international 
standards. The on -going  work by the OIV on the update of the international standard for certificates 
of analy sis should also be taken into account in this respect. The European Union considers that it 
is crucial to address the differences between the standards of the Excise Department and 
internationally accepted practices, which may be an obstacle for future tra de flows of safe alcohol 
products.  
1.440.   The delegation of New Zealand  provided the following statement. New Zealand supports 
concerns raised by other Members. New Zealand acknowledges and supports Thailand's right to 
introduce new regulations to address specifi c public health concerns. New Zealand appreciates that 
in seeking to address the harmful use of alcohol, the technical regulation is directed toward s 
achieving a legitimate public health objective. However, New Zealand exporters continue to face 
uncertaint y with regards to certification requirements and have concerns about the impact of the 
additional testing requirements on their ability to gain timely certification for exports. New Zealand 
would appreciate an update as to whether Thailand has given any fu rther consideration to accepting 
other recogni zed industry certification that achieves the stated objectives? New Zealand remains 
eager to work with the Thai Government to ensure New Zealand exporters meet Thailand's objectives 
under these regulations thro ugh the least trade -restrictive means.  
1.441.   The delegation of Japan  provided the following statement. Japan also has concerns on this 
issue raised by the European Union. Japan understands that requesting a Certificate of Analysis 
when importing liquors to Thail and is a necessary measure to ensure the health and safety of  
consumers in Thailand. However, some of the items required in the certificate include those that are 
not generally analy sed in Japan. Also, submitting a sample to Thailand's Excise Department wh en 
applying for importation is a burden on exporters, etc. , in terms of costs and procedures, which 
leads to trade obstacle. Japan requests Thailand to review the measure in the future, taking into 
account the concerns submitted from the WTO Members, so th at exporters can trade with minimal 
restrictions.  
1.442.   The delegation of Canada  provided the following statement. Canada appreciates the bilateral 
dialogue with Thailand at the last TBT Committee where Canada had an opportunity to share with 
 
77 For previous statements follow the thread under IMS ID  556 (under dates raised and references) . G/TBT/M/81  
 
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  Thailand the existi ng limit differences of some substances between the Certificate of Analysis 
requirements established by Thai Excise Department and those accepted in Canada. Canada remains 
very interested in Thailand's consideration of amending the threshold limits of thos e substances that 
are difficult to match as currently established in the Thai Certificate of Analysis. Canada strongly 
encourages Thailand to consider harmonization of Thai's Certificate of Analysis requirements with 
scientifically based internationally re cognized standards to avoid unnecessary and unjustifiable 
barriers to trade. In particular, Canada is interested in knowing whether Thailand would consider 
accepting other foreign recognized Certificate of Analysis issued by accredited laboratories such as  
those accepted in Canada without having to demonstrate that all substance levels match those of 
Thailand. Canada would like to thank Thailand for the bilateral engagement to date and is keen to 
continue to work with Thailand to facilitate trade of alcohol ic beverages to Thailand for the Canadian 
industry.  
1.443.   In response, the delegation of Thailand  provided the following statement. Thailand 
appreciates the comments from the European Union, Canada, Japan and New Zealand that 
expressed their concerns on Thai liq uor analysis standard. In this regard, Thailand would like to 
inform the WTO Members that the substances specified in Thai liquor analysis standard have 
previously been found in the imported and domestically produced liquor products in the last five 
years. In addition, those substances have been tested and the results have been shown that these 
substances have some adverse effects on Thai people's health. Therefore, to protect Thai people's 
health and safety, it was deemed necessary to establish the maximum limits for the additives and 
contaminants based on Codex Standards and maximum limit for the other chemical substance 
attributes were set according to the Acceptable Daily Intake (ADI) at the level that are suitable for 
Thai people.  
1.444.   As Canada and N ew Zealand expressed their concerns on the acceptance of other recognized 
industry certification and the Certificate of Analysis issued by the accredited laboratories, Thailand 
would like to inform that the test method for each individual substance specifi ed in the Certificate of 
Analysis must be accredited according to ISO/IEC 17025 or recognized by International Organization 
Standards or Regional Organization Standards. In case of other test methods that are not considered 
as the equivalent test method ba sed on the above -mentioned  standards, the importers can submit 
the test methods to the Development of Analytical Standard on Excisable Products Committee set 
up by the Excise Department to consider whether such test methods are equivalent to or can be 
recognized as the test methods mentioned in the Ministerial Regulation on Liquor Importation 
Permission and the Notification of Excise Department, which has been amended on 5 June 2019. 
Finally, Thailand stands ready to work with all WTO Members in order to pr omote international trade 
and maintain mutually beneficial trading relationships.  
1.3.41   Brazil – Technical Regulation 14, 8 February 2018, to set the additional official 
identity, quality standards for wine and derivatives 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/956  (IMS ID 
56878) 
1.445.   The delegation of the European Union  provided the following statement. The European Union 
would like to thank Brazi l for their constructive approach, which resulted in the simplification of the 
list of certification parameters for imported wine, in particular the removal of some burdensome 
parameters, sweeteners and colours (adoption of Technical Regulation 75 of 31 De cember 2019, 
notified to the TBT Committee as G/TBT/N/BRA/956) . Nevertheless, the European Union would like 
to recall some of the concerns raised in EU written comments and in previous meetings of this 
Committee that remain relevant. With regard to the list of certification param eters for imported 
wine, the EU would like to ask Brazil for the reasons for systematic analysis of methanol, which 
makes imports of small volumes of wine very difficult. Methanol is naturally produced in wine during 
the alcoholic fermentation and accordin g to scientific studies performed by the E FSA, it does not 
represent a food safety concern.  
1.446.   As noted previously, several content limits required by the Brazilian technical regulations are 
not aligned to the OIV recommendations, in particular maximum limits  for total acidity. Other limits, 
for example for chlorides and ashes are not covered by OIV recommendations. In addition, the OIV 
non-compliant limits for alcoholic degree would not cover, for example, EU wines covered by 
 
78 For previous statements follow the thread under IMS ID  568 (under dates raised and references) . G/TBT/M/81  
 
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  geographical indication with alcoholic limits that can go down to 4 .5% volume. Finally , as repeatedly 
raised by the EU, the sugar content limits diverging from OIV are causing long -standing  problems 
for imports of EU sparkling wines. The EU wine importers point out to the lengthy and cumb ersome 
customs procedures in Brazil, including counter -analysis of certification parameters. The divergence 
of test methods from OIV standards also causes difficulties for imports, as the results may differ 
from the results in the Certificate of Analysis i n origin. The EU would like to ask Brazil for the reasons 
behind these requirements, which would seem disproportionate for low -risk products such as wine. 
In conclusion, the European Union would also like to reiterate the invitation to make use to the 
maximum extent possible of the recommendations of the OIV when revising the relevant technical 
regulations and to consider accepting imported wines made according to oenological practices 
authori zed by the OIV. The European Union is prepared to work bilaterall y with Brazil in this respect.  
1.447.   The delegation of the United States  provided the following statement. During the February 
2020 TBT Committee meeting Brazil asserted that the requirements outlined in Normative 
Instruction No. 75 were previously in force purs uant to Technical Regulations 14, 48, and 67. 
Further, Brazil indicated during that meeting that it finds the revised requirements to be trade 
facilitating rather than restricting because the new requirements constitute a reduction from 15 to 
7 analytes. T he United States thanks Brazil for this reduction in analytical requirements but notes 
the challenges that exporters continue to face satisfying the existing requirements. The analyses 
required concerning ash content and methanol, in particular, are unnece ssary and cost prohibitive 
for exporters. The United States notes that the analysis of ash content is uncommon and has become 
an inherent barrier to trade. Further, it is our understanding that Brazil will require both a Certificate 
of Analysis and an "Import Inspection Pre -Certification Report " ("Laudo Pre Certificado de Inspeção 
de Importação ") containing several additional analyses apart from those required in the Certificate 
of Analysis. The Import Inspection Pre -Certification Report would be generated by a Brazilian 
laboratory upon importation. The United States is not aware of any other market that requires 
laboratory analysis, and corresponding certification, in both the exporting and importing countries 
for a single shipment. Can Brazil please explai n the rationale for these seemingly burdensome 
requirements that are likely to restrict trade? Are both certificates always required for all wine 
imports? We hope for the opportunity to continue to discuss these requirements with you bilaterally 
so that tr ade in wine is not disrupted.  
1.448.   The delegation of New Zealand  provided the following statement. New Zealand refers to our 
previous statements on this STC, which continues to significantly affect New Zealand wine exporters. 
New Zealand thanks Brazil for the b ilateral engagement on this matter.  
1.449.   In response, the delegation of Brazil  provided the following statement. Brazil thanks New 
Zealand, the EU and the US for their comments. Brazil acknowledges that, upon raising this STC, 
Members have also referred to Technical Regulation 75, published on 31 December 2019 and notified 
to the Committee on 14 January 2020 under document G/TBT/N/BRA/956 . Brazil considers that the 
above -mentioned  technical regulations (TR 14, 48 and 75) are necessary to guarantee the qua lity 
of wines consumed in national territory. Technical Regulation 75, which came into force on 2 January 
2020, defines the criteria and analytical parameters to be used in the inspection and control of 
national and imported wine and derivatives of grape a nd wine products. In this context, it is 
important to remember that Technical Regulations 14 and 48 defined, for both domestic and foreign 
producers, physical -chemical analytical parameters for wine and derivatives of grape and wine 
products. With subseque nt Technical Regulation 67, notified as G/TBT/N/ BRA/853, the models of 
certificates and related documents required for certification for the export and import of drinks, 
acetic fermented wines and grape and wine derivatives were approved. Among other elements, 
Technical Regulation 67 requires the presentation of analysis results for the parameters defined in 
Technical Regulations 14 and 48. It is important to highlight, with regard to these Technical 
Regulations, that Brazil provided a grace period of 365 days for countries to adapt  to the new 
requirements.  
1.450.   Technical Regulation 75, on the other hand, establishes the analytical parameters that must 
be included in the laboratory reports used in the inspection and control of imported and national 
beverages. These analytical parameters a re set out in Operational Standard No. 1, of 24 January 
2020. Therefore, the number of parameters is reduced to seven, in comparison with the 15 
parameters contained in the provisions of Technical Regulations 14 and 48. TR 75 does not pose 
new requirements . The practical effect of such measures, by decreasing the ratio of physical -
chemical parameters required by Technical Regulations 14 and 48, is to make the technical criteria 
for imported wine less trade restrictive. It is our understanding that Technical  Regulation 75 is a G/TBT/M/81  
 
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  trade -facilitating measure when compared to past regulations. Brazil is a growing wine consumer 
and producer, a condition that entails regulatory action for the sector. When developing new 
regulations on wine, Brazil will continue to ab ide by WTO rules.  
1.3.42   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 Regulation (EC) No 1275/2008 and  
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes) , 
G/TBT/N/EU/609  (IMS ID 57579) 
1.451.   The delegation of China  provided the following statement. The EU notified the draft 
regulation (Draft Commission Regulation laying down ecodesign requirements for electronic di splays 
(G/TBT/N/EU/609))  on 9 October 2018 . After the comment period, the European Commission 
revised the R egulation and announced a new version on 8 May 2019. On 25 December 2019, EU 
published the Regulation in the Official Journal (OJ), which was scheduled to take effect on 1 M arch 
2021. Compared with the original one, the latest version added new requirements, especially for 
prohibiting using halogenated flame retardants ; such new requirements have not been notified to 
WTO. We suggest EU to notify such new requirements to WTO a nd allow reasonable time for other 
Members to make comments.  
1.452.   China raised concerns at the 78th, 79th, 80th, 81st and this TBT Committee meetings, 
proposing EU to delete the provisions on the prohibition of halogen flame retardants and reduce the 
requiremen ts on the energy efficiency limit of OLED displays. At the 81st meeting, the European 
Union replied that  "the requirement aims at increasing the yield of recycled plastics once the 
displays, at their end of life, are treated at recycling plants, because cu rrently the plastics containing 
any of the halogenated compounds are systematically incinerated. " For the concerns about reducing 
the energy efficiency limit of OLED TV displays , the EU did not respond. We thank EU for reply , but 
after a careful study of the EU's treatment flow of WEEE  plastics, we believe that the reasons given 
in the reply are not tenable. Based on this and other unresponsive matters, we present the following 
comments.  
1.453.   Exempt "LED displays" from the scope of the Regulation : According to (EU) 2019/2021 
Article 2(5), digital signage display shall include five features, however, RJ45 network cable 
transmits video signals for the LED display, not the network signal. Therefore, it is not completely 
consistent with (C) of five features, and LED display should not be judged as a digital signage display. 
If the LED display is included in the digital signage display for management, it shall conform to the 
requirements of table 2 in (EU) 2019/2021 C of ANNEX II, that is,  off mode 0.3W, standby mode 
2.2W, network standby mode 7.7W. However, due to the product characteristics, the single power 
consumption of the LED display plus the self -power consumption of the receiving card far exceeds 
the maximum requirement (7.7W), and  the current international advanced level can only reach 15W. 
Existing products and the technology can not meet the requirements of the regulation, which will 
impede the LED display from entering the EU market, thereby affecting the use of LED display in 
various application scenarios such as stage, billboard, touring, etc., and undermine the interests of 
EU end customers. In addition, the EU's energy efficiency requirements for digital signage display 
are much higher than international standards. For example , the United States and Japan do not lay 
down energy efficiency standards for LED display and digital signage display. Therefore, it is 
recommended that the EU exempt "LED displays" from the scope of the Regulations.  
1.454.   Reduce the energy efficiency limit for OLED displays : We did not receive any reply on this 
problem at previous TBT Committee meetings. In the Regulation, although the correction parameter 
is revised to 10 considering the technical characteristics of OLED displays, the standard for 
calculating t he EEI value (energy efficiency index) of OLED displays is still higher than the 
requirement of most Members, such as the United States and Japan. According to Article s 2.2 and 
2.5 of the TBT Agreement, we recommend the EU to further reduce the energy effi ciency limit for 
OLED displays or explain the rational e for the limit.  
1.455.   Delete the ban of halogenated flame retardants in D4 Annex II : The restriction for halogen 
flame retardants in Annex II D of the Regulation was a significant change that would affect gl obal 
chemical sectors. According to Article 2.9 of the TBT Agreement, we would like to suggest EU to 
notify this requirement. Secondly, EU replied at the 81st TBT Committee meeting that the 
 
79 For previous statements follow the thread under IMS ID  575 (under dates raised and references) . G/TBT/M/81  
 
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  requirement aims at increasing the yield of recycled plastics beca use currently the plastics containing 
any of the halogenated compounds are systematically incinerated. However, in accordance with Page 
2 of Responsible Recycling of WEEE Plastics Containing Brominated Flame Retardants80, WEEE 
plastics containing bromine le ss than 2000 pm are recycled in EU. As to WEEE plastics containing 
bromine more than 2000 pm, 92% still can be recycled and only 8% containing restricted BFRs are 
incinerated , and it also gives the name and thresholds of the restricted BFRs. The treatment flow 
demonstrates that EERA can soundly treat WEEE plastics containing BFRs in accordance with EN 
50625 -1 General Treatment and Depollution Standard, which is not all incinerated as mentioned in 
the reply. Thirdly, the plastics with halogen flame retardant s have the unique advantage according 
to the mechanic process for plastics. ABS plastics added with halogen flame retardants can maintain 
their original fire safety after four or five times of recycling. This is exactly in line with the aim of the 
Circular  Economy Strategy. In addition, there has never been no international practice as restriction 
on all halogen flame retardants. Therefore, according to Articles 2.2 and  2.4 of the TBT Agreement, 
we recommend the EU to reconsider the restrictions for all hal ogen flame retardants according to 
scientific basis and delete the requirement of D4 Annex II. If it cannot  be deleted, please give the 
specific names and clarify the thresholds of the restricted halogenated flame retardants.  
1.456.   Exempt "status displays and co ntrol panels" from the scope of the regulation, consistent with 
the notification G/TBT/N/EU/609 : We have not yet received any response to this concern from the 
EU at 79th -81st TBT Committee meetings  and a specific reply from the EU side will be highly 
appreciated.  
1.457.   The delegation of Brazil  provided the following statement. Brazil would like to second some 
of the concerns raised by China with regard to this STC. We have received complaints from our 
private sector, which will be particularly affected by the prohibition  on the use of halogenated flame 
retardants in the enclosure and stand of electronic displays, according to The New Version Annex II 
D, related to "materials efficiency". As mentioned in our statement in the TBT meeting of last 
November, we understand that  such requirements are not even in line with the REACH Regulation 
and the R oHS Directive. The potentially conflicting regulatory requirements between those measures 
and the Eco -design Directive raise questions about transparency in regulating these product s. We 
acknowledge the EU concerns with the fact that HFRs in enclosures and stands of electronic displays 
could hinder recycling of WEEE plastics. However, our private sector has indicated that the recycling 
of brominated flame retardants, for instance, is  being well managed by innovative plastics and 
polymer recyclers. Therefore, Brazil asks the European Union to consider withdrawing such 
burdensome and trade -restrictive requirements.  
1.458.   In response, the delegation of the European Union  provided the following  statement. The 
European Union thanks China and Brazil for raising this issue. As regards China's points. Point 1: 
The Commission confirms that the WTO TBT notification of 8 October 2018 presented the final draft 
that the Commission proposed to the represe ntatives of member States and that draft represented 
the Commission position. Comments received within the deadline were examined and taken into due 
consideration. Points 2.1, 2.2 and 2.4: On 8 October 2018, the Commission notified the draft 
Regulation and  two months were provided for comments. The comments received in due time were 
considered, the draft requirements amended where relevant, the final Regulation text voted by 
member States, the Draft Regulation adopted by the Commission and finally published  in the Official 
Journal of the European Union on 5 December 2019. Although the Commission understands that the 
Regulation may give rise to new and different views and opinions, no further modification is possible 
at this stage; this would require a restar ting of a regulatory process. With respect to the higher 
ambition of EU regulations compared to other administrations, this is in line with the legitimate policy 
objective of the EU to mitigate climate change and become a carbon neutral continent no later than 
2050.  
1.459.   However, in respect to the specific issues raised. Point 2.1: The Commission recalls that 
industry representatives are deeply involved in the preparation and discussion of requirements. No 
concerns have been expressed by industry, including the biggest worldwide display manufacturers, 
on the feasibility of requirements that China is mentioning. Point 2.2: A careful reading of the 
Regulation can reveal that OLED displays get a correction factor, discounting the minimum 
requirements for OLED displa ys to be placed on the EU market, until 28 February 2023 (Annex II, 
point A.1.). Point 2.4: Status displays and control panels are only in scope for material efficiency 
 
80 https://www.eera -recyclers.com/publications . 
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  requirements. Displays that are components or subassemblies are out of scope. Point 2.3 : The 
Commission consulted EERA and asked confirmation of the understanding of the documentation that 
China signalled. We confirm, once more, that the EERA documentation81 indicates that 8% of plastics 
are incinerated because they contain BFR; the 8% fraction is an average for different products 
(higher for televisions and other displays) and represents the fraction of plastics containing 
halogenated flame retardants (generally 10 to 25% in weight for electronic displays such  as TVs). 
As China correctl y notes, WEEE plastics containing residual bromine (i.e. less than 2000  ppm), 
represent, on average, 92% of plastics yield and can still be recycled. However, 8% on average (but 
far more for displays) of plastics, containing any BFR (restricted or not), ar e all incinerated. We 
kindly invite you to more carefully analyse the drawing on page 2 of the document of EERA to which 
you refer.82 Consequently, the rationale for the restriction of HFRs in the enclosure and stand, and 
all evidence collected and summaris ed in the Impact Assessment , is perfectly in line with the 
documentation from the recycling industry association that China signalled. Moreover, "possible " 
presence of HFRs requires a costly selection process that would be otherwise avoided, should the 
enclosure and stands be HFR -free by design. Thus, the restriction will have the further side effect, 
in the future, of streamlining the plastics treatment and reducing plastics selections costs.  
1.460.   With respect to the request of thresholds for residual content, we are pleased to confirm that 
draft Guidelines are being discussed with relevant stakeholders. In accordance with the limits that 
RoHS sets for placing plastics in the EU market, including the recycled plastics resulting from 
treatment of future electroni c displays, once at their end of life, we confirm that a threshold of 
1000 ppm (or 0 .1% in weight for homogeneous materials) is considered, for any halogenated flame 
retardant, in line with RoHS legislation in force.  
1.461.   As regards Brazil's points: The Ecodesi gn requirement in the above -mentioned regulation, 
in respect to the restrictions on the use of halogenated flame retardants, is complementary and not 
overlapping with RoHS, REACH and WEEE legislation. Maximum concentration values tolerated of 
halogenated f lame retardants in the enclosure and in the stand of displays are in line with RoHS 
limits, i.e. 0.1% (1000  ppm) of any halogenated flame retardant for each homogeneous material 
part. This requirement has been introduced to streamline the selection process  by the WEEE 
recycling industry in the EU for electronic displays in the future and to avoid that a relevant fraction 
of these plastics (i.e. all those where the content of halogenated flame retardants cannot be reliably 
and consistently measured below the  1000 ppm threshold) is incinerated, as currently commonly 
done.  
1.3.43   European Union – Medical Device Regulation (MDR) and In Vitro Diagnostic 
Medical Devices Regulation (IVDR) , G/TBT/N/EU/71/Add.1 , G/TBT/N/EU/72 , 
G/TBT/N/EU/72/Add.1  (IMS ID 59483) 
1.462.   The delegation of the United States  provided the following statement. The Unite d States 
supports the development and enforcement of a well -defined medical device regulatory system that 
assures the safety and performance of medical devices especially now given the global health crisis 
we are facing. However, we continue to have seriou s concerns regarding the implementation of the 
MDR and IVDR, and our industry remains worried about its continued access to the EU's USD 125 
billion medical device market, USD 20 billion of which  is supplied by U S products. We have been 
articulating two major concerns: first, there remains an insufficient number of Notified Bodies 
designated to perform certification activities under the MDR/IVDR; second, the EU has drafted an 
insufficient number of the implementing  acts needed to provide detailed guidance about how 
industry can ensure their products comply with the new product standards. Given the one-year delay 
in implementation approved last month due to the global pandemic, what steps does the EU foresee 
taking t o address these concerns to ensure that we are not facing the same difficulties a year from 
now and there is not a market shortage of medical devices?  
1.463.   The delegation of the Republic of Korea  provided the following statement. Korea would like 
to make some c omments regarding this regulation as follows. Korea supports the legislative 
objectives of the regulation which is to ensure the safety and quality of medical devices in the EU 
market. We also appreciate the European Commission's decision to postpone the i mplementation of 
 
81 https://www.eera -recyclers.com/files/eera -bfrs-folder -online -2.pdf. 
82 https://www.eera -recyclers.com/files/eera -bfrs-folder -online -3-may-2020.pdf   i.e. https://www.eera -
recyclers.com/publications . 
83 For previous statements follow the thread under IMS ID  594 (under dates raised and references) . G/TBT/M/81  
 
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  the MDR for one year in order to allow member States, health institutions and economic operators 
to focus on responding to the global pandemic. However, we would like to reiterate several concerns 
from the Korean industry that has not yet been addressed regarding the implementation of the 
regulation. According to our understanding, only 12 Notified Bodies have been designated to perform 
CE certification activities under the MDR as of now. Considering that there remains an insufficient 
numbe r of Notified Bodies designated to perform the certification activities in accordance with the 
MDR, we are concerned whether the demands of exporters could be met. The European Commission 
has been drafting the implementing acts and guidelines aimed to unde rpin the implementation of 
the MDR. However, their provision has been delayed, hampering the Korean industry's effort to 
prepare for the implementation of the new regulation. Given these concerns, Korea would like to 
request the EU to designate sufficient number of Notified Bodies as soon as practicable and share 
any updated information such as the list of newly designated Notified Bodies in order to facilitate 
the implementation of regulation. Furthermore, we kindly ask the EU to provide a meaningful 
transition period for Korean exporters to comply with the MDR.  
1.464.   The delegation of Japan  provided the following statement. Japan would like to express its 
support for the development of medical device regulations setting high standards of quality and 
safety for m edical devices. In addition, Japan welcomes that the adoption of the proposal by the 
European Parliament and the Council to postpone the date of application of M DR until 26 May 2021 
in order to focus on the fight against the coronavirus pandemic. Japan rec ognizes that the majority 
of Notified Bodies (NBs) have not yet performed conformity assessment activities under the MDR in 
Japan. Therefore, regarding the postponement, Japan would like to request that the EU ensure that 
manufacturers can place new or imp roved products with new functions on the EU market in 
accordance with Medical Device Directive until the newly stipulated date of MDR application. 
Furthermore, Japan continues to request that the EU : (i) ensure that NBs have sufficient capacity to 
issue ce rtifications in a timely manner, including commencement of evaluation by NB's branch offices 
in Japan;  (ii) issue necessary MDCG guidance quickly ; and  (iii) share information regarding the 
legislation plan for implementation laws, so as to enable Japanese manufacturers to ensure 
compliance with MDR before the revised application date.  
1.465.   The delegation of China  provided the following statement. The EU notified the Proposal for 
a Regulation of the in vitro  diagnostic medical devices ( G/TBT/N/EU/72)  on 23 October 2012, and 
notified the fir st reading of the revision of the regulation ( G/TBT/N/EU/72 /Add.1)  on 23 March 2017. 
On 5 May 2017, the EU issued the regulation (EU) 2017/746 on in vitro  diagnostic medical devices 
(IVDR), repealed Directive 98/79/EC (IVDD) and Commission Decision 2010/227/EU, which shal l 
apply from 26 May 2022. China raised concerns at the 80th TBT Committee meeting, proposing EU 
to speed up the authorization of testing agencies, simplify the certification process and postpone the 
implementation time. The EU replied that "Based on curren t information available, estimates indicate 
that approximately 20 Notified Bodies might be designated under the Medical Devices Regulations 
by the end of the year. Notified Bodies have increased their resources by an average of 50% for the 
assessment of me dical devices and by up to 200% for the assessment of IVDs ". For the concern 
about simplification of the certification process ，the EU did not respond. We appreciate EU for the 
reply, but after a careful study for the number of N Bs, we believe that it is no t enough for 
manufacturers to quickly obtain CE certification.  
1.466.   Therefore, we present the following comments. Postpone the implementation of IVDR for 2 
years : According to estimates, about 85% of the in vitro  diagnostic medical devices entering the EU 
market must be assessed by Notified Body to obtain a CE certificate for the purpose of compliance 
with IVDR regulations, rather than in the form of "self -declaration" ，while the proportion is only 
15% for compliance with IVDD regulations. Even a large number of  in vitro diagnostic devices have 
obtained valid IVDD  certificates, they still need to be re -certified according to the requirements of 
new products. However, at present, the EU has announced only three  NBs, and has neither issued, 
nor updated the list of EU harmonized standards, nor the more detailed certif ication guidelines, and 
no laboratory has been authorized by the EU reference laboratory yet. If such a situation continues, 
it will be difficult for manufacturers to rectify according to the list of harmonized standards, as well 
as to conduct tests in aut horized laboratories and obtain certificates issued by the notified body in a 
timely manner. Therefore, we propose to postpone the implementation of IVDR from May 2022 to 
May 2024.  
1.467.   Provide a simplified certification for devices that have been CE certified : Products (with List 
B and above risk) that have been on the market or have been in use for many years, have continuous 
quality and safety assurance, as they have been CE certified according to the IVDD regulations. For G/TBT/M/81  
 
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  these products, in light of continui ty of IVDD and IVDR regulations, we suggest EU to provide a 
simplified certification so as to ensure a smooth transition of regulations. Expedite the announcement 
of laboratory authorization and preparation : According to the classification requirements of the IVDR 
regulations, in addition to applying for a CE certificate for exporting high -risk products to the EU, 
inspection at an authorized laboratory is also required. Therefore, manufacturers need to consider 
the laboratory resources in advance while appl ying for product certification. However, the EU has 
not announced any laboratories that have been authorized. As the certification of high -risk products 
takes a relatively long time, manufacturers can't choose the suitable laboratory and make 
corresponding  preparations, which will make it more difficult to be certified. Accelerate the 
establishment of the EUDAMED medical device database : According to the requirements of the IVDR 
regulations, all medical device manufacturers that export to the EU need to app ly for SRN (Single 
Registration Number) in EU medical device database before obtaining the CE certificate. At present, 
the EU has not confirmed the medical device database and the relevant SRN guidelines for 
application, which has made medical device manuf acturers unable to properly prepare application 
materials and complete the preparatory work for CE certification.  
1.468.   The delegation of Mexico  provided the following statement. The delegation of Mexico  
reiterates its support for the development and improvement  of regulatory frameworks that promote 
product quality. However, it is important that such regulatory frameworks and any changes thereto 
do not generate unnecessary obstacles to trade.  The delegation of Mexico therefore rei terates its 
request for updates o n the implementation of the new regulatory framework for medical devices and 
in vitro diagnostic medical devices (IVDs). The European Union notified this new regulatory 
framework on 23 October 2012 and on 22 March 2017 in documents G/TBT/N/EU/72 , 
G/TBT/EU/N/71/Add.1  and G/TBT/EU/N/72/Add.1 . Mexico's interest in this matt er is based on its 
concern that the time frames, infrastructure and number of certified bodies may be insufficient and 
affect Mexican exporters.  We thank the European Union for giving its attention to this matter and 
look forward to receiving the informati on and updates requested.  
1.469.   In response, the delegation of the European Union  provided the following statement. Thank 
you to the WTO Members for their comments on the M DR and IVDR. The new legislation on medical 
devices was adopted by the Council and the Eur opean Parliament in April 2017. This new framework 
sets high standards of quality and safety for medical devices and aims at ensuring the smooth 
functioning of the internal market. The new provisions were scheduled to apply from 26 May 2020 
for medical dev ices and 26  May 2022 for in vitro  diagnostic medical devices. In view of the 
exceptional current circumstances of the COVID -19 crisis and, with patient health and safety as a 
guiding principle, the date of application of the MDR has been postponed until 26  May 2021. This 
postponement takes the pressure off national authorities, Notified Bodies, manufacturers and other 
actors so they can focus fully on urgent priorities related to the COVID -19 crisis. The IVDR's84 
corresponding date of application remains the same (May 2022). The Commission continues to 
monitor the impact of the COVID -19 crisis with regard to this application date.  
1.470.   The Commission and member States are continuing the work on implementing acts and 
guidelines under the current circumstances. The new legislation contains about 80 empowerments 
for different types of implementing acts, but only a few such acts are necessary for rendering the 
legislation operational. To date, there have been over 45 publis hed guidance documents and several 
key and much awaited guidance on clinical requirements has been published recently. In addition, 
the date for the launch of expert panels, as well as the registration module of the E UDAMED  
database, have been adapted to t he new application date and will be in place well before May 2021. 
The other parts of the E UDAMED  database will be made gradually available. The legislation provides, 
in the meantime, for alternatives to the E UDAMED  use. 
1.471.   To date, there have been 18 designa tions of Notified Bodies under the two new regulations, 
15 under the MDR and three  under the IVDR. Notified Bodies designated under the MDR reportedly 
hold a significant share of the market and have already accepted above 750 applications. The 
Commission i s also expecting a significant increase in the course of this year. Additionally, the grace 
mechanism to smoothen the transition will remain in place. The new MDR thus continues to 
recogni ze, under certain conditions, the certificates issued in accordance with the current EU's 
Medical Device Directive through the MDR's transition period (i.e. until May 2024), provided the 
 
84 Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 on in -
vitro diagnostic medical devices and rep ealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 
117, 5.5.2017, p. 176).  G/TBT/M/81  
 
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  certificate has not reached its expiry date. We understand that a majority of manufacturers intend 
to make use of this transitional tool and have renewed their existing certificates to that purpose. As 
a final resort (in duly justified cases and in the interest of public health or patient health or safety), 
national competent authorities may authori ze within their territory the placing on t he market of 
specific devices which have not fulfilled the conformity assessment requirements. In exceptional 
cases, the Commission may decide to extend those national measures to the territory of the Union 
for a limited duration. The EU is fully committed  to ensure that the new system provides a higher 
level of patient protection.  
1.3.44   European Union – Concerns on regulations with regard to eco -design requirements 
for various products in EU , G/TBT/N/EU/606 , G/TBT/N/EU/607 , G/TBT/N/EU/615  (IMS 
ID 59285) 
1.472.   The delegation of China  provided the following statement. China would like to reiterate our 
concerns on EU eco -design requirements on light sources, and household washing machines. For the 
eco-design requirements for light sources, in accordance with Article 2.4 of the TBT Agreement, we 
recommend EU use IEC standards for colour consistency and cal culation of lumen maintenance factor 
of LED lights. We suggest that EU clarify the test method for the "Pst LM " value of "Flicker for LED 
and OLED MLS " and "SVM" value of "Stroboscopic effect for LED and OLED MLS ". For the testing of 
verification tolerance s, we recommend EU use the current international standards such as 
IEC62717:2014+AMD1:2015 and IEC62612:2013+AMD1:2015+AMD2:2018. We also recommend 
EU to cancel the tolerance requirement of the "related colour temperature [K] " to avoid unnecessary 
obstacle s to trade. Comparing the light efficiency parameters set by the eco -design requirements 
and the energy labelling regulation ( G/TBT/N/EU/607) , there is a major discrepancy. Light sources 
with the best available technology in terms of efficacy according to the eco -design requirement s 
could only meet the energy efficiency class D of the energy labelling regulation. We therefore 
strongly recommend EU to adjust energy efficiency rating in the energy labelling regulation.  
1.473.   We suggest EU give a clearer definition on products subject to the  eco-design requirements 
on washing machines and washer dryers, and clarify whether washing machines without heating 
function are subject to the regulation. In the notified eco -design requirements on household washing 
machines, there is a provision that "manufacturers or importers shall deliver the necessary spare 
parts for household washing machines and household washer dryers to professional repairers within 
15 working days after having received the order ". There is a similar provision in the ecodesign 
requirements for household dishwashers. As spare parts delivery is a pure business practice, such 
requirements would be very difficult for oversea s manufacturers, and we strongly recommend EU 
revoke such requ irements so as to avoid unnecessary barriers to trade.  
1.474.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks China for raising this issue. As regards household washing machines, from 
the consultation of stakeholders, 15 working days was considered a balanced compromise between 
the time required for providing spare parts and the time acceptable for a consumer to wait in order 
to have a fully -functioning product. In our view, this provision does not crea te unnecessary barriers 
to trade given the supply chains of manufacturers and the possibility of using intermediary storage 
facilities. The ecodesign regulation definition is: "household washing machine" means an automatic 
washing machine which cleans and rinses household laundry by using water, chemical, mechanical 
and thermal means, which also has a spin extraction function, and which is declared by the 
manufacturer in the declaration of conformity as complying with Directive 2014/35/EU of the 
European Pa rliament and of the Council or with Directive 2014/53/EU of the European Parliament 
and of the Council.  
1.475.   As regards lighting and the use of standards, neither the ecodesign regulation, nor the 
energy labelling regulation describe or prescribe any testing me thods. Furthermore, Annex II of 
Regulation 2019/2020 and Article 6 of Regulation 2019/2015 provide that measurements and 
calculations shall be made using "reliable, accurate and reproducible methods, which take into 
account the generally recognised state o f the art ", as long as the standards used are specified in the 
technical documentation. Thus, the regulations are flexible in their approach to testing methods, and 
do not restrict them to the use of European harmoni zed standards that are referenced in the  Official 
Journal of the European Union. Other state -of-the-art test standards could be used, provided that 
they are suitable for measuring the parameters that are regulated. With regard to the use of 
 
85 For previous statements follow the thread under IMS ID  592 (under dates raised and referen ces). G/TBT/M/81  
 
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  tolerances in lighting, the ecodesign regulation is con sistent with the regulations for other product 
groups and all take a unified approach under the EU ecodesign framework. All tolerances to be used 
for market surveilance in the EU are included in the applicable ecodesign regulations. It should be 
noted that  these tolerances refer only to the verification of product parameters carried out by EU 
member State authorities. They do not refer to other tolerances described in some measurement 
standards, e.g. tolerances on test conditions or manufacturing tolerances . 
1.476.   With regard to the energy efficiency index, the energy labelling requirements for light 
sources were established based on the provisions of the Energy Labelling framework regulation ((EU) 
2017/1369). Article 11 lays down the procedure for the introductio n and rescaling of labels. Point 
(9) of that article requires that, for technologies that are expected to develop more rapidly, 
requirements shall be laid down so that no products would be expected to fall into energy classes A 
and B at the moment of the i ntroduction of the label. Furthermore, the estimated time within which 
a majority of models are expected to fall into class A should be of at least 10 years (point 8, same 
article).  
1.477.   The studies completed for supporting the adoption of the new ecodesign and  energy labelling 
regulations for light sources showed that a limited number of products comply currently with the 
requirements of the energy class C. Furthermore, due to technology advances, it is expected that 
more products would comply with the requirem ents applicable to class C by the time these new 
requirements will start to apply, i.e. 1 September 2021.  
1.478.   Background on Lighting : Commission Regulation (EU) 2019/2020 of 1 October 2019 laying 
down ecodesign requirements for light sources and separate contr ol gears pursuant to Directive 
2009/125/EC of the European Parliament and of the Council and repealing Commission Regulations 
(EC) No 244/2009, (EC) No 245/2009 and (EU) No 1194/2012 was published in the Official Journal 
of the European Union on 5 December  2019.86 Commission Delegated Regulation (EU) 2019/2015 
of 11 March 2019 supplementing Regulation (EU) 2017/1369 of the European Parliament and of the 
Council with regard to energy labelling of light sources and repealing Commission Delegated 
Regulation (EU ) No 874/2012 was published in the Official Journal of the European Union on 
5 December 2019.87 The full impact assessment accompanying the two regulations was published 
on the EUR -LEX portal at the same date.88 
1.3.45   Pakistan – Amendment to Pakistan's Imports and  Exports (Control) Act, 1950: 
Statutory Regulatory Order (SRO) 237 on label ling, shelf  life, and halal certification , 
G/TBT/N/PAK/119  (IMS ID 60789) 
1.479.   The delegation of the United States  provided the following statement. As our previous 
statements in November 2019 and February 2020 in dicated, the United States requests that Pakistan 
suspend implementation of its measure on Halal labelling, shelf life and Halal certification and notify 
the WTO TBT Committee. Please allow 60 -90 days for other WTO Members to submit comments and 
take into account those comments. The United States has also enquired about the additional 
guidance issued on 31 July by the Pakistani Ministry of Commerce. The memorandum states that 
raw and semi -processed agricultural products "may not " require Halal certification . We have not yet 
received clarification on the meaning of "may not " and the exact scope of products that might be 
exempt from Halal certification. Further, despite requests from the European Union and the United 
States, Pakistan has yet to make any changes to its policy to allow the use of stickers or 
complimentary labels, which would make the requirements less burdensome. Finally , we continue 
to seek clarity on whether Pakistan will exempt products weighing more than three kilograms from 
Halal certification to enable Pakistan's foodservice sector to access critical inputs. We look forward 
to continued engagement with Pakistan and to resolution of our concerns.  
1.480.   The delegation of the European Union  provided the following statement. The European Union 
would like to signal its concerns regarding Pakistan's order on labelling, shelf  life, and Halal 
certification. The EU regrets that reg ulations establishing import requirements for foodstuff have 
been adopted without prior notification to the WTO TBT or SPS Committee. The EU stresses the 
 
86 https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=uriserv:OJ.L_.2019.315.01.0209.01.ENG . 
87 https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2019.315.01.0068.01.ENG&toc=OJ:L:2019:315:TOC . 
88 https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex:52019SC0357 . 
89 For previous statements follow the thread under IMS ID  607 (under dates raised and references) . G/TBT/M/81  
 
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  importance to notify any future revisions to the WTO in the draft stage, providing WTO Members 
with op portunity to comment. The conditions laid out with regard to labelling are discouraging for 
EU importers especially given that the use of stickers, overprinting, stamp or scratched labelling is 
prohibited. Given the lack of sufficient transitional period, these requirements considerably delay 
approvals of imported products for Pakistani market and the fact that no change was introduced 
with regard to labelling and certification clauses in the subsequent Rule i.e. SRO 438 (dated 9 April 
2019). Could Pakistan  kindly consider suspending the implementation of SROs 237 for at least 
18 months to allow adaptation period for the EU exporters?  
1.481.   In response, the delegation of Pakistan  provided the following statement. Pakistan would 
like to thank the US and other Membe rs for their continued interest in this issue. Discussions in the 
TBT Committee have permitted Members to comment on earlier versions of SRO 237, and Pakistan 
has taken into consideration all those comments and observations. The subject SRO 237 has been 
notified to the TBT Committee on 1 3 May 2020 circulated by the Secretariat in document number 
G/TBT/N/PAK/120 . Pakistan would like to reconfirm that the welfare of consumers has been the 
prime objective of these regulatory measures, i.e. to ensure healthy, safe and Halal food product s 
in the market. The measures were introduced after detailed discussions and agreement among all 
public and private sector stakeholders including FMCG importers. The labelling requirements help 
consumers to make informed choices about their dietary decisio ns. The system of Halal certification 
provides a traceable mechanism of the Halal character of food products.  
1.482.   The measures are implemented in a completely non -discriminatory manner. They are applied 
on MFN basis and guarantee National Treatment by equal enforcement on domestic producers as 
well. Furthermore, to provide sufficient time to overseas manufacturers and suppliers to adjust to 
the import conditions of the SRO 237, the operation of the SRO was postponed for more than 
120 days. SRO 237 was o riginally enforced on 19 February 2019. However, after expiry of the sunset 
period (suspension), it was fully implemented from 1 July 2019 through SRO 438(I)/2019 dated 
9 April 2019. To further facilitate exporting enterprises to comply with the requiremen ts of the SRO, 
the operation of clause -iii-d was postponed until 30 April 2020 through SRO 258(I)/2020 dated 
26 March 2020.  
1.483.   To address questions regarding the date of implementation, scope and interpretation of 
different provisions, the Ministry of Commerc e issued three clarifications on 19  March 2019, 31  July 
2019 and 10  March 2020. Briefly, the clarifications state that SRO 237 will not apply to those import 
shipments which were in the pipeline before 19 Feb ruary  2019. The clarifications also address the 
application of the SRO on agriculture products, labelling requirements for consumer and bulk 
packaging, translation of scientific terms on labels, and lastly that, the SRO does not apply to 
"diabetic food products intended for special medical purposes ". 
1.484.   Concerning the clarifications sought on the requirement of Halal certification it is clarified 
that it is not required for agricultural products in raw and semi -processed form, i.e. fresh fruits and 
vegetable, and dried fruits and vegetables (semi processed) . However, all edible products and by -
products of "animal origin " do require Halal certificate. It is also clarified, as requested, that the 
condition of an accompanying Halal certificate applies equally (except agricultural products in raw 
and semi -proces sed form as explained earlier) regardless of size, weight, or type of packaging. Bulk 
packaging meant for industrial consumers is exempt ed only from other labelling requirements. 
Lastly, the proposal for the use of stickers or complimentary labels was cons idered but was found to 
be impracticable at this stage being prone to misuse, and resultantly affecting health and wellbeing 
of Pakistani consumers. Pakistan hopes that the above notes and clarifications would adequately 
address the concerns of Members. We  remain open to engaging further with concerned Member(s) 
to address any issues.  
1.3.46   Republic of Korea – Ballast Water Management Act (IMS ID 60690) 
1.485.   The delegation of the European Union  provided the following statement. I take this 
opportunity to recall that in previous Committee  meetings  the EU raised its concerns with regard to 
South Korea's requirements on the certification of ballast water treatment systems (BWTS) 
manufactured by EU companies for vessels registered under the Korean flag, in particular, regarding 
the fees requested and the time needed to review tests already performed. South Korea has 
confirmed that the Ballast Water Management Act of 2017 does not discriminate between  foreign 
 
90 For previous statements follow the thread under IMS ID  606 (under dates raised and references) . G/TBT/M/81  
 
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  manufacturers and domestic producers as regards procedures and costs. However, with reference 
to Articles 5.1.2 and 5.2.3 of the TBT Agreement on conformity assessment procedures, we note 
that the measure is acting as a trade barrier for EU compan ies and the fees appear disproportionate. 
We take note of the recent information received from the South Korean authorities according to 
which the European company's application is currently under review, together with other six Korean 
manufacturers, and s hould be completed soon. We are looking forward for a swift issuance of the 
BWMS certificate to the European company.  
1.486.   In response, the delegation of the Republic of Korea  provided the following statement. Korea 
would like to thank Member countries' interes t on this regulation. In response to them Korea want 
to express the regulatory authority's opinion briefly. The Ministry of Oceans and Fisheries (MOF), 
which is in charge of addressing maritime -related laws and regulations, has thoroughly reviewed the 
concerns raised by the EU on its Ballast Water Management Act. In its understanding, the EU is 
concerned that Korean Administration type approval process takes more costs and time compared 
to those of the EU. Due to different circumstances in each country, typ e approval process, including 
costs and time, is varying from country to country. The Korean government applies its regulations 
to domestic and foreign manufactures in the same manner. It goes the same for the EU 
manufacturers. Korea would like to reiterat e that there is no trade barrier to particular areas in 
applying the regulations in the Korea. However, as we have done thus far, Korea will continue to 
make efforts to facilitate the improvement of the type approval process. Any comments or inquiry 
will be received by MOF, the competent authority of Korea.  
1.3.47   Kingdom of Saudi Arabia – Electrical Clothes Dryers Energy Performance 
Requirements and Labelling , G/TBT/N/SAU/987  (IMS ID 60591) 
1.487.   The delegation of the Republic of Korea  provided the following statement. The Korea would 
like to re place our requests to the one mentioned at the last regular meeting of the WTO TBT 
Committee. In relation to this issue, Saudi Arabia has informed that Saudi Arabia agreed with our 
requests and decided to amend the regulation for our proposal by the end of  2020. The Korea would 
like to thank you for your efforts to harmonize with the international standard and hope s for this 
regulation to be modified as soon as possible. And Korea would like to ask relevant authority to 
share the timeline of the amendment p rocess.  
1.488.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement. 
Saudi Arabia thanks the Republic of Korea for raising this concern and Saudi Arabia as we mentioned 
in our last response to this specific concern agreed to  modified SASO 2883 based on the suggestion 
provided from the Korea side. Thus, tolerance ratios have been modified in the standard to match 
the tolerance in SASO  IEC 60335 -1 and the modification draft has been prepared and will be 
announced soon.  
1.3.48   Kingdom of Saudi Arabia – Saber Conformity Assessment Online Platform / Saleem 
Product Safety Program (IMS ID 61592) 
1.489.   The delegation of the European Union  provided the following statement. The European Union 
remains concerned by the difficulties related to the imple mentation of the electronic certification 
system Saleem through the web -portal Saber that was recently launched by the Kingdom of Saudi 
Arabia. These difficulties have a major negative impact on the imports of several products from the 
European Union to Sa udi Arabia. Toys and ceramics are particularly affected, but the system is being 
gradually extended to other products, many of them exported by EU companies. While the 
conformity assessment requirements differ depending on the sector, several EU industries  coincide 
in reporting their overly costly, burdensome and time -consuming nature. Notably, EU toy 
manufacturers continue to report difficulties related to obtaining a GCC Conformity Tracking Symbol 
(so-called GCTS) from notified bodies authori zed by SASO. This requires sending a wide range of 
technical documentation and payment of duplicated fees – not only to the notified body but also to 
the G SO that issues the GCTS. Additional administrative steps, requiring further documentation 
submissions and fees, in clude the online registration of each shipment and the request of a Shipment 
Certificate of Conformity (SC oC), and a Product Certificate of Conformity (PC oC) for each HTS code.  
 
91 For previous statements foll ow the thread under IMS ID  605 (under dates raised and references) . 
92 For previous statements follow the thread under IMS ID  615 (under dates raised and references) . G/TBT/M/81  
 
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  1.490.   According to the reports from EU exporters further delays are caused by the lac k of sufficient 
resources and internal guidelines for the processing of applications for GCTS. The European Union 
respectfully urges Saudi Arabia to simplify the requirements of the new system in order to address 
in particular the specificities of the toy sector. This should include allowing for an efficient system of 
grouping several SKUs with similar characteristics under one GCTS, as well as a possibility of adding 
new products to an existing GCTS covering a similar group. Moreover, requests for document ation 
during the GCTS certification process should be kept to the minimum necessary to assess the safety 
of products. No additional certificates of conformity, such as PC oC, should be requested, when the 
GCTS had already been issued. The registration and r enewal costs for GCTS should also be minimi zed 
and proportionate to the service provided. There is no justification for the GCTS renewal costs since 
this is just a formal process, executed online by the manufacturer.  
1.491.   The European Union would also like to a sk the Saudi authorities to ensure the confidentiality 
in the process. Currently the GCTS public website shows pictures of all products, including products 
before their release, revealing therefore very sensitive business information to competitors. The 
ceramic sector is also very significantly affected by recent introduction of significantly stricter 
conformity assessment requirements by Saudi Arabia that require complex certification by 
conformity assessment bodies of products that are in their majority c onsidered low  risk. EU 
companies are facing long delays with regard to their on -going  applications for the Saudi Quality 
Mark, reporting difficulties related to communication with authori zed conformity assessment bodies 
and with the Saudi administration, u nclear requirements regarding documents to be submitted and 
disproportionate fees. This has caused in the past several months a de facto paralysis of EU exports 
of ceramics to Saudi Arabia.  
1.492.   On a more positive note, with regard to ceramic products, the Euro pean Union would like to 
appreciate the fruitful bilateral contacts with the Saudi authorities. The European Union suggested 
several ways to improve the situation, including , inter alia , authori zation of higher number of 
conformity assessment bodies established in the EU. The EU would like to express hope that these 
discussions will lead to satisfactory solution for EU exporters, and that imports of high -quality EU 
ceramic products to Saudi Arabia will soon return to normal. In addition, the EU would like to ask 
Saudi Arabia for a clarification whether it would be obligatory for importing companies to have a 
legal representative established in Saudi Arabia and if yes, which would be the legal requirements 
and obligations of such representative. In conc lusion, the European Union would like to kindly invite 
the Kingdom of Saudi Arabia to ensure efficient and less costly procedures for all products included 
in the new conformity assessment system and looks forward to further cooperation with the Saudi 
authorities for this purpose.  
1.493.   The delegation of the United States  provided the following statement. Can the Saudi Arabia 
SASO provide the list of products (using complete HS Codes having 10 digits) for which SASO will 
require third -party certification and new certificates of conformity instead of self -declarations? 
Companies are reporting that a significant number of their manufactured products are not certified 
every year, and therefore, SASO's requirement for valid certificates of conformity within the last 1 2 
months is difficult and costly to meet, creating unnecessary obstacles to international trade. Under 
Saleem Saber, companies have reported that SASO has imposed additional test requirements for 
products to enter the Saudi market that were previously not required. One US textile company has 
reported that the number of tests required increased from one per year to 10 or more per year. US 
companies have also indicated that their manufacturers and importers have been required to provide 
accreditation to ISO 1 7025, a standard for testing labs, as part of the Certificate of Conformity 
process, even when they use third -party labs for testing rather than their own facilities and are not 
required to provide this type of documentation in other markets. Would SASO co nsider exempting 
companies from this requirement if they use ILAC -accredited third -party labs for testing?  
1.494.   The United States thanks SASO and the GCC Standardization Organization for working with 
industry stakeholders to adopt a more effective process for g rouping toys. Industry proposals 
included: ( i) allowing one GC TS registration number for a range of similar toys, meaning toys of the 
same type or HS code, toys covered by the same standards and age range, and when similar toys 
are produced by the same man ufacturer in different countries; ( ii) implementing an efficient and 
inexpensive process that limits the number of documents Notified Bodies need to review for GCTS 
"groups "; and ( iii) making groupings as wide as possible with no limit on the number of S KUs. 
1.495.   The delegation of Switzerland  provided the following statement. Switzerland would like to 
reiterate its concerns over the implementation of the Saleem Product Safety Programme on the G/TBT/M/81  
 
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  Saber Conformity Assessment Online Platform. Our industry, in particul ar the textiles and machinery 
sector, raised concerns regarding the implementation of the registration and certification process. 
The requirements of the new system create uncertainty, lack clear and transparent guidelines and 
seem to be applied differentl y by the authorities. It also remains unclear for which products a Product 
Certificate of Conformity (PCoC) needs to be issued. The registration and certification process is 
costly and burdensome for our exporters. The manner of "grouping " individual produ cts, in some 
cases under several HS codes, leads to disproportionate costs and documentation requirements 
which may be prohibitive to enter the market, especially for companies exporting quality and luxury 
products in small quantities. Moreover, the certif icates of conformity are valid only for 12 months, 
which creates additional burdens to the industry. Switzerland calls on the Kingdom of Saudi Arabia 
to simply the registration and certification process, to implement clear and transparent guidelines 
and to  ensure that the requirements are applied in an equal and uniform manner. The documentation 
and certification requirements, as well as registration and certification fees should be kept to what 
is necessary to assure an effective implementation of the requ irements. Switzerland looks forward 
to further cooperation on this topic and would appreciate if the Kingdom of Saudi  Arabia could take 
these comments into account.  
1.496.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement . 
Saudi Arabia thanks the European Union, United States and Switzerland for raising concerns 
regarding Saber Conformity Assessment Online Platform / Saleem Product Safety Program. S aleem  
programme works through the development of an integrated systems of r egulations and standards 
that conform to internationally recognized professional practices by developing a highly efficient 
system for measuring product safety indicator in the market through mechanisms and procedures 
that comply with the technical regulat ions of each product, especially essential requirements for 
health of human and animals, environment protection, and rationalization of energy and water 
consumption, as well as the compatibility of products with societal and religious values and ethics, 
and ensure the effectiveness of the services provided by legislative and regulatory bodies to achieve 
safety by conformity of those products to SASO Standards. Saber platform was created to ease 
traceability and to ensure product compliance. Multiple organiz ations are involved in the process and 
linked to the S aber platform to assure ease of communication and to improve the services provided 
to the consumer. Registering in Saber is only for the suppliers and local manufacturers who have 
Saudi commercial regis ter and the cost of reviewing the technical file and issuing the Certificate of 
Conformity and the shipment certificate are fixed and known by all certification bodies.  
1.497.   The validity of the certificate is one year for the Certificate of Conformity and three  years for 
the Saudi quality mark as well as the G -Mark. However, the test report can be valid for three to five 
years if nothing has been changed in the production line or the composite of the product. In Saber 
platform, clients can search by six digits s elect from the results for the nearest description of their 
product. In terms of GSO toy regulation, GCTS tracking symbol must be issued through GSO 
platform . Once the GCTS is obtained, the shipment certificates can be easily issued through Saber 
platform.  We strongly advise all toys industries to contact the notified bodies according to the GSO 
Technical Regulation for Toys scheme (listed in Saber platform) for detailed explanations regarding 
the test report and GCTS requirements.  
1.3.49   Mongolia – Mandatory Requ irement for Enrichment of Agricultural Products with 
Vitamins (IMS ID 61693) 
1.498.   The delegation of the Russian Federation  provided the following statement. In 2018 Mongolia 
adopted a Law on the Enrichment of Food Products, which entered into force in December 2 019. 
Mongolia declared that this Law was intended to protect human health and to prevent humans from 
vitamin and mineral compounds deficiency. The list of products subject to mandatory vitaminization 
entered into force only in December 2019. And only at th e end of December 2019 Mongolia issued 
a standard on wheat flour enrichment, which defines the complex of vitamins and mineral 
compounds for the product. According to the standard wheat flour shall be enriched with vitamins B 
and D, folacin, ferrum and zin c. In light of this, the Russian Federation would like to express its 
concern with regard to the date of entering the standard into force. The timeframe for producers 
and exporters of wheat flour to adapt their products or methods of production to new requ irements 
was just one day. Thus, by the absence of prior publication and the failure to provide reasonable 
 
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  timeframe for adaptation Mongolia acted inconsistently with its obligations under the TBT 
Agreement, in particular, Articles 2.9, 2.11 and 2.12.  
1.499.   Due to the fact that the W HO recommendation (that Mongolia had been referring to) uses 
different methodology with respect to the dosage of vitamins and mineral compounds, the Russian 
Federation is seeking further clarification on whether the current technical regulation conforms to 
the relevant international standard. In view of this, we would also like to make a point that the rules 
for production, storage and transportation of enriched food products and labelling requirements, 
including a particular sign indicating the vitaminizatio n of food products, were put into force only on 
30 January 2020 , making the following the technical regulation from the day it entered into force 
impossible. Moreover, it becomes clearer that even now there is no wheat flour with a special 
vitaminization s ign on Mongolian market.  
1.500.   In this regard, the Russian Federation expresses concern with respect to capability of 
national producers of wheat flour to follow the vitaminization requirement. The fact that Mongolian 
producers have the right to sell their unenr iched flour, while import of the same product is not 
allowed, in fact accords less favourable treatment for imported flour and thus contravenes Article  2.1 
of the TBT Agreement. Moreover, Russia raises doubts about the proportionality of this measure and 
considers it might be more trade restrictive than necessary to fulfil legitimate objectives under 
Article  2.2 of the TBT Agreement. In this regard, we kindly ask Mongolia to give substantive 
clarifications on necessity for applying additional mandatory requ irements in respect of wheat flour. 
Taking into account all the above, the Russian Federation is looking forward to get ting further 
clarifications regarding the issues raised in our statement today. We will continue to carefully monitor 
the implementation of this measure in order to examine its compliance with the WTO rules.  
1.501.   The delegation of Mongolia  did not provide a response to the concerns raised. These concerns 
were subsequently transmitted to the relevant authorities.  
1.3.50   European Union – Regulation (EC) No 1107/2009 – non-renewal of approval of the 
active substance picoxystrobin , G/TBT/N/EU/437  (IMS ID 53594) 
1.502.   The delegation of Brazil  provided the following statement. In yet another opportunity, Brazil 
would like to express concerns regarding the EU's non -renewal of picoxystrobin regi stries. In January 
2017, the EU notified to the TBT Committee that the approval of picoxystrobin was not renewed, 
according to its TBT notification G/TBT/N/EU/ 437. In January 2019, the EU decided to establish very 
restrictive M RLs for seven substances, including picoxystrobin and bup rofezin, which are important 
for Brazil's exports of agricultural commodities. We consider that the transitional period provided for 
producers to adapt to the new MRLs was unreasonable, given that studies conducted by E FSA were 
inconclusive, not based in d ue risk  analysis and inconsistent with CODEX guidelines. Council Directive 
91/414/EEC of the European Commission declared that picoxystrobin was not toxic, the report of 
the E FSA claimed that it was not possible to deliver final conclusions on the genotoxi c potential of 
picoxystrobin based on the available data. The Food and Agriculture Organization and the W HO 
specialists had also concluded that the substance was not genotoxic. This substance is used in more 
than 65 countries and has been approved by many bodies, such as the US Environmental Protection 
Agency, the Canadian Management Regulatory Agency, the Japanese Agency and the Brazilian 
Health Regulatory Agency. Our delegation considers that the MRLs for picoxystrobin was already 
very low – for instance,  for soybeans the default was set on 0.01  mg/kg. Therefore, we kindly ask 
the EU to consider aligning its decision on renewal of approval of active substances with scientific 
consensus regarding the safety of substances and their use to protect crops.  
1.503.   The delegation of Paraguay  provided the following statement. We thank the delegation of 
Brazil for once again including this item on the agenda. My delegation reiterates its concern about 
the decision made by the European Union not to renew the approval of picoxystrobin, and the cr iteria 
used to make this decision. We wish to refer to our previous statement concerning this agenda item 
made during the March 2019 TBT Committee meeting, as follows. 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, a s 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 noted that at the 
 
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  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 . 
1.504.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks WTO Members for raising this issue. As explained in detail at previous TBT 
Committees, the European Commission decided not to renew the approval of picoxystrobin through 
Commission Implementing Regulation (EU) 2017/1455. Authori zations for plant protection products 
containing picoxystrobin in the EU were required to be withdrawn b y 30 November  2017. Member 
States were permitted to allow for a grace period until 30 November 2018 at the latest. The European 
Union notified third countries of the draft Regulation via the TBT procedure. The measure did not 
lead to immediate disruptions in trade, as the measure itself does not amend the M RLs and provides 
for a grace period for use of products containing picoxystrobin. Given the issues identified by the 
EFSA, the existing MRLs were reviewed in a separate measure in view of their safety to consumers.  
1.505.   A draft measure lowering the MRLs for picoxystrobin to the limit of quantification (LOQ ) was 
prepared and presented to the Standing Committee on Plants, Animals, Food and Feed. The 
European Union notified third countries of the draft Regulation via the SPS procedure. Comments 
received from non -EU countries and stakeholders were available to the Standing Committee, where 
a summary of the key points raised was presented. The Standing Committee gave a favourable 
opinion on the draft. The European Commission formally adopted the revised MRLs in January 2019. 
The revised MRLs are applicable since 13 August 2019. Import tolerance requests however remain 
possible and will be assessed on a case -by-case basis by EFSA. Such requests would have to be 
supported by substantial new data addressing the concerns.  
1.3.51   Republic of Korea – Package Recycle Classifica tion Regulation , 
G/TBT/N/K OR/843 , G/TBT/N/KOR/844 , G/TBT/N/KOR/857 , G/TBT/N/KOR/857/Add.1  
(IMS ID 58895) 
1.506.   The delegation of Canada  provided the following statement. Canada wishes to reiterate its 
concerns with the Republic of Korea's Package Recycle Classification Regulation, notified under 
G/TBT/N/KOR/843 , G/TBT/N/KOR/844  and G/TBT/N/KOR/857 . Korea has already  adopted the new 
regulation, yet the questions sent by Canada via the Korean Enquiry Point in November 2019 remain 
unanswered. This lingering situation does not foster transparency on, and understanding of, the 
regulation by interested Canadian stakeholder s. Can Korea provide us with an update on when 
Canada should expect to receive answers to its questions? It is still unclear for us as to why 
packaging is treated differently based on its use, and not the material from which it is made. A glass 
bottle cont aining soju or whisk y should have the same degree of recyclability than another bottle – 
made of the same material – containing a different substance. Can Korea explain why it selected an 
approach based on the "function " of the packaging rather than on the  material itself? What risks of 
non-fulfilment would Korea face if it were to allow all glass -made containers to be easily recyclable?  
1.507.   Canada still believes that there were international standards which Korea could have relied 
upon to achieve the same poli cy objective and minimize potential trade distortions, and continues 
to ask if Korea has taken international standards into account in the development of its measure, 
namely in its distinction of products that are "easy" or "difficult " to recycle. Canada w ould also note 
that, at the last Committee meeting, Korea committed to share with all Members the final version 
of this regulation, including the Package Recycling Classification Regulation. Canadian stakeholders 
are looking forward to seeing this final ve rsion. Can Korea provide an update on when the documents 
will be shared with all WTO Members? Canada looks forward to receiving written answers from Korea 
on our letter of comments sent on November 2019, and thanks Korea for its continued engagement 
on thi s STC.  
1.508.   The delegation of New Zealand  provided the following statement. New Zealand supports 
concerns raised by other Members.  New Zealand supports measures that focus on legitimate 
objectives, including those that produce positive environmental outcomes, s uch as encouraging 
recycling and reducing waste. However, as an exporter of food and beverage products, New Zealand 
is interested in understanding how Korea's proposed measures are no more trade restrictive than 
 
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  necessary. We encourage Korea to consider ho w their measures will impact a wide range of products, 
including consideration of potential exemptions and flexibility in the scheme. We respectfully request 
that Korea ensures that transparent and clear guidelines are published on how exporters can comply  
with these measures. In particular, we ask that such guidelines set out what is and is not classified 
as "recycle friendly " and the consequences of such classification, to ensure traders can easily comply 
with the regime and not incur unnecessary barriers  or costs to trade.  
1.509.   The delegation of Mexico  provided the following statement. Mexico supports the specific 
trade concern of Canada and New Zealand regarding the amendment made by the Republic of Korea 
to the Sub Act on the Promotion of Saving and Recyclin g of Resources, notified to members of the 
Committee on Technical Barriers to Trade (TBT Committee) in documents G/TBT/N/KOR/857  and 
G/TBT/N/KOR/857/Add.1  dated 9 September 2019 and 11 November 2019, respectively.  At the TBT 
Committee meeting in February 2020, the delegation of the Republic of K orea gave a statement 
regarding this specific trade concern, which indicated the following : Wine and  whisky bottles – 
consider ed products difficult to recycle – will be excluded from the obligation to indicate "difficult to 
recycle" on their labels . The fi nal version of this regulation, including the Package Recycling 
Classification Regulation, would soon be shared with the m embers  of this Committee . Only those 
products graded the "lowest " as "difficult to recycle" were obliged to indicate the recyclability  class 
on their labels . 
1.510.   From what was said at the meeting in February 2020, it is difficult to identify the criteria 
used by the Korean authorities to exclude certain alcoholic beverages from the obligation to indicate 
the recyclability class on their labels . In the specific case of Mexico, bottles containing tequila that 
are exported to the Republic of Korea are made from various  materials, not all of which could be 
classed as "difficult to recycle". This complicates our understanding and makes it uncl ear as to 
whether the measure would apply to bottles of tequila or whether, in some way, it could be 
established that tequila is excluded from the obligation to indicate the applicable recyclability class 
on its labels . In light of the foregoing , Mexico requests the delegation of the Republic of Korea to : 
confirm whether bottles of tequila would be covered by this regulation or whether they might be 
excluded from the labelling obligation, like wine and whisky; share the criteria used to determine 
the exclus ion of certain alcoholic beverages from compliance with the labelling requirement; and 
circulate the final version of the regulation, including the Package Recycling Classification Regulation . 
Mexico thanks the delegation of the Republic of Korea for givin g its consideration to this statement 
and to the requests made therein . 
1.511.   The delegation of Australia  provided the following statement. Australia recogni zes the 
Republic of Korea's right to implement regulations that promote the reduction of waste and the 
production of easily recyclable packaging materials. Australia thanks Korea for providing an exclusion 
from displaying recyclability evaluation results on wine bottles ( "labelling exemption "). Australia 
seeks clarification on whether an exemption similar to the labelling exemption will be provided to 
wine bottles for the environmental fee attached to products categori zed as "difficult " to recycle.  
1.512.   In response, the delegation of the Republic of Korea  provided the following statement. Korea 
appreciates the inte rest of the Member s in Korea's regulation on packaging materials. The official 
response from the regulatory authority is as follows. Recently in Korea, public interest in recycling 
has increased due to limited landfill space and emerging waste disposal iss ues. A government -led 
study by an expert group was conducted to establish a clear set of standards for determining 
recyclability of packaging materials. The standards have been further improved through the 
consultation process involving more than a hundred  relevant industries and professionals from April 
to June 2019 and this revision work was completed in December 2019. In revising the existing 
standards, overseas cases and standards of EU (EPBP), UK, Japan and other major countries were 
taken into conside ration.  
1.513.   The recyclability of packaging could vary depending on their colours and use of detachable 
connections even if they use same materials. For instance, transparent, green and brown -coloured 
glass bottles have recycling demands, but other colours are rarely recycled in Korea and mostly 
discarded resulting in an increase in wastes. Based on observations of the U S and European cases, 
mixed colour glasses were found to have a significantly lower recycling value than those with single 
colour. Most mixed co lour glass bottles end up being recycled only once instead of being continuously 
reused as bottles. However, as new recyling methods continuously develop and circumstances 
evolve, the standards could be further revised to accommodate changing reality.  G/TBT/M/81  
 
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  1.514.   We understand that Member countries are concerned about discrimination between domestic 
liquor bottles (such as soju) and other glass bottles (such as wine). However, this is not a policy to 
discriminate against a certain industry, and does not actually act as  a discriminatory factor. The new 
recyclability classification for packaging materials is the result of a full consideration of the comments 
from Member s. For example, although glass bottles of wine and whisky products are indeed difficult 
to recycle in Ko rea, they are to be excluded from the obligation to indicate "difficult to recycle " on 
their labels. Such additional clause was concluded on 17 February 2020 taking into account that 
packaging of certain types of products has few available alternatives. Th e final version of this 
regulation including the Package Recycling Classification Regulation will soon be notified to the 
Membe rs. Full information on this final version of the regulation is now open to public and available 
on Korea's legislation informati on system.  
1.515.   Korea's extended producer responsibility (EPR) scheme imposes product manufacturers the 
obligation to collect and recycle the wastes derived from their products. More detailed evaluation 
guidelines were provided directly to all affected companie s that paid allotted charges of EPR in Korea. 
And specific details on the EPR allotted charges for the "difficult to recycle" grade will be made in 
this year, and will be shared with all affected companies. After the entry into force of this regulation, 
a two-year grace period in total – nine months for classification assessment (from 25 December 
2019 to 24 September 2020) and 15 months for label ling (from 25 September 2020 to 24 December 
2021) – will be given to ensure the industry is prepared for changing regulatory circumstances. In 
addition, only those products that are graded the lowest as "difficult to recycle " are obliged to 
indicate the recyclability class on their labels. Korea will remain accountable and transparent in 
implementing this recycling regulation.  
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