RESTRICTED  
  
G/TBT/M/82  
 
 
5 January 2021  
(21-0079) Page: 1/123 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 28-29 OCTOBER  2020  
CHAIR: MR LAURENCE SANDRAL  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ ........................  1 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................ . 1 
2.1   Specific Trade Concerns  ................................ ................................ ...............................  1 
2.2   Exchange of Experiences  ................................ ................................ ...........................  119 
2.3   Other Matters  ................................ ................................ ................................ ..........  123 
3   NINTH TRIENNIAL REVIEW  ................................ ................................ .....................  123  
4   TECHNICAL COOPERATION ACTIVITIES  ................................ ................................ .. 123  
5   UPDATING BY OBSERVERS  ................................ ................................ ......................  123  
6   ANNUAL REPORT (2020) OF THE COMMITTEE TO THE COUNCIL FOR  
TRADE IN GOODS  ................................ ................................ ................................ .........  123  
7   DATE OF NEXT MEETING ................................ ................................ ..........................  123  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 18. 
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
2.1.1   Withdrawn concerns  
2.1.  The Chair  reported that the following STCs had been withdrawn from the agenda at the request 
of the concerned Mem ber: 
• European Union - Amendments of UN Regulation No.22 
(ECE/TRANS/WP.29/2020/60_Protective helmets)  
• Thailand - Ministerial Regulations on Standards Marks and Rules/Procedures for 
Licenses for Industrial Products B.E. 2563 (2020)  
• United States - Guidance on Federal Conformity Assessment Activities (IMS ID 625)  
 
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/82  
 
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  2.1.2   New Specific Trade Concerns  
2.1.2.1   China - Provisions for Cosmetics Registration (Draft for Comments), 
G/TBT/N/CHN/1454  (IMS ID 6412) 
2.2.  The representative of Japan  provided the following statement.  Regarding China's draft of the 
"Provisions for Cosmetics Registration ", we appreciate that China provided the opportunity to 
comment on the WTO/TBT notification. As we have noted in the comment to the WTO/TBT 
notification, Japan would like to express the following concerns. First, r egarding information 
disclosure, in the context of protection of intellectual property, Japan requests that confidential 
corporate information specified by registrants or filers not be disclosed to the public. In case it is 
necessary to disclose such specified confidential information, registrants or filers should be given 
the opportunity to consult with the National Medical Products Administration ( NMPA ) in advance. In 
particular, Japan would like to request that confidentia l corporate  information  be protected in the 
following cases. Regarding disclosure of summary of evidence for efficacy claim to the public on the 
websites designated by NMPA, Japan requests that the scope of disclosure be clarified so as to 
exclude confiden tial corporate information. In addition, "Provisions for Cosmetics Registration " 
requires registrants or filers to indicate the source of the ingredients and their quality specification, 
to provide all manufacturing process information and to configure pro duct standards during 
registration or filing process. Furthermore, this provision and "Instructions for Cosmetic Registration 
and Notification Dossiers ", which had been out for public comment in August, provide to publish all 
or part of the submitted infor mation. Since the submitted information includes confidential corporate 
information, Japan would like to request to China that the scope of submitted information be 
minimized as much as possible and that confidential corporate information not be subject to  
disclosure and be kept it secret. Second, t he sales certifications proving that the products have been 
sold on the market in the country of production are imposed only on imported cosmetics. Products 
imported from the territory of any Member shall be acco rded treatment no less favourable than that 
accorded to like products of national origin.  
2.3.  Third, "Instructions for Cosmetic Registration and Notification Dossiers " provides cases where 
original registration or filing is cancelled and subsequent re -registra tion or re -filing is necessary, and 
cases where only changes of original registration or filing are required. Japan would like to request 
that it is not necessary to cancel original registration or filing if changes are not related to product 
safety or rel ated to a product's name. Fourth, r egarding testing laboratories, China's regulations do 
not accept 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 la boratories through internationally 
recognized practices such as ISO can be accepted. Fifth, a s "Cosmetics Supervision and 
Administration Regulation " and its implementing regulations will cause great change, a reasonable 
transition period is necessary to en sure business continuity. Japan would like to request that China 
provide an adequate grace period, at least one year after promulgation of all relevant regulations, 
in order to allow time for producers to adapt to a new cosmetic regulatory system.  
2.4.  The repr esentative of the United States  provided the following statement. The cosmetics 
industry is a bright spot in the growth of China's rising bilateral trade with the United States and 
indeed the world. From 2017 to 2019, Chinese imports of US cosmetics increa sed by an incredible 
69%, showing the value that Chinese consumers place on US products. Likewise, the United States 
is a significant consumer of Chinese cosmetics and many US cosmetics companies have significant 
investments in China that serve Chinese con sumers and manufacture products for export. Given 
projections that China's cosmetics market will more than double in the next ten years from USD 50 
billion to USD  100 billion, there is significant potential to drive growth via trade for the thousands of 
foreign and Chinese small and medium enterprises that operate in this industry. In the "Provisions 
for Cosmetics Registration" ( G/TBT/N/CHN/1454 ) China references vague requirements for 
companies' quality management systems. In the subsequent "Instructions for Cosmetics 
Registratio n and Notification Dossiers", which would implement the "Provisions for Cosmetics 
Registration", China continues its requirement for animal testing of imported products, if the 
importer cannot provide a Good Manufacturing Practices ( GMP) certification from  its national 
regulator. This requirement brings into question China's commitment to growing bilateral cosmetics 
trade, as it creates an unnecessary obstacle to international trade.  
 
2 For previous statements follow the thread under IMS ID  641 (under dates raised and references) . G/TBT/M/82  
 
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  2.5.  In the past year, the United States, other WTO Members and industry have a ll met with Chinese 
trade and NMPA officials to explain that regulator -issued GMP certificates are not available in some 
countries, but that third -party certification per the ISO cosmetics GMP standard (22716:2007) is 
available, if self -certification is in sufficient. The continued insistence by China for a regulator -issued 
certification, when one is not available in some countries and while viable alternatives exist, brings 
into question China's commitment to its obligations under the TBT Agreement. In addi tion, while the 
United States appreciates China's commitment to reduce the time required to receive approvals to 
market cosmetics products and new ingredients, we are concerned that NMPA's new filing and 
registration requirements may require more informati on than necessary to fulfil its objective of 
managing product safety in China's cosmetics marketplace.  
2.6.  US companies, in comments submitted to China, have raised concerns that the proposed 
documentation requirements are so extensive and prescriptive as to d iscourage innovation, while 
putting companies' intellectual property and CBI at risk. For example, G/TBT/N/CHN/1454  requires 
cosmetics companies to submit an enterprise standard, which specifies the step -by-step process and 
methods by which products are manufactured. The measure also requires, for market access, 
disclosures to third -party testing and registration agents of CBI and potential trade secrets in filings 
and registrations for cosmetics and cosmetics ingredients. US cosmetics companies are concerned 
that these requiremen ts will put their intellectual property at risk of unauthorized disclosure and will 
fail to protect their legitimate commercial interests. We also question the provision requiring 
companies to disclose on a public website CBI, including potential trade sec rets, about their 
ingredients, products and the analytical methods used to validate claims. This will not assist 
consumers in understanding product claims, but will be of interest to potential competitors. Given 
these concerns, we urge China to evaluate th e necessity of requiring such extensive documentation, 
particularly given its enhanced requirements for company testing of product and ingredient safety 
and NMPA increased investments in post -market monitoring. As will be expressed in our subsequent 
interv ention on Cosmetics Supervision and Administration Regulation (CSAR), we expect these 
measures to have a significant effect on trade and therefore ask that China notify all draft 
implementing measures to the WTO ahead of CSAR's January 2021 implementation.  
2.7.  The representative of the Republic of Korea  provided the following statement. Korea supports 
China's effort to adopt and reflect global trends in the regulation of the ingredients, mixing, labelling 
and advertisement of cosmetic products. Starting from th e preparation of the "Cosmetic Supervision 
and Administration Regulation " scheduled to take effect in January 2021, China has made various 
efforts including the revision and legislation of relevant subordinate regulations. We hope that such 
efforts come to  fruition through the cosmetics regulation currently under the process of legislation 
and revision. However, Korea would like to share a few trade concerns regarding the draft "Provisions 
for Cosmetics Registration " notified to the WTO in August 2020. Acco rding to Article 36 of the 
Provision, applicants applying for the approval or registration of cosmetics are required to clarify the 
source and quality specifications of all ingredients in the application. However, the scope of required 
documents on ingredi ents remains unclear. If the scope of the required documents includes the 
specifications of all ingredients, Korea believes that the Regulation is more trade restrictive than 
necessary to fulfil a legitimate objective. Applicants have already been submitti ng data on new or 
harmful ingredients as part of the safety evaluation report included in the application for approval. 
Furthermore, the source and quality data of all ingredients are considered as trade secrets. 
Therefore, Korea would like to request Chin a to consider revising the provision.  
2.8.  According to Article 43 on the efficacy data of cosmetics, a summary of cosmetic efficacy claims 
must be disclosed to the public at the dedicated website designated by the NMPA. However, even 
the minimal requirements t o be included in the summary contain a number of trade secrets that are 
critical to businesses. Thus, Korea calls on China to remove the disclosure provision. Under Article 
48 and 59, China requires applicants to withdraw the pre -existing product registrat ion or approval 
and newly apply for a registration or an approval when there are changes to the product name, 
applicant information, and the address of the domestic responsible agent. Since these are minor 
changes that do not have significant implications for the safety and efficacy of the product, Korea 
kindly asks China to require post -approval or post -registration changes instead of re -registrations 
or re-authorizations. Such practices would create an unnecessary trade barrier by costing time and 
imposin g administrative burden on the cosmetics industry. Fourth, Korea invites China to share 
information on the date of entry into force and status of the provision and grant reasonable transition 
period of at least one year for the industry to prepare to compl y with the new requirements according 
to the TBT Agreement's Article 2.12. Korea would like to recall Article 2.2 of the TBT Agreement, G/TBT/M/82  
 
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  according to which Members shall ensure that technical regulations are not prepared, adopted or 
applied with a view to o r with the effect of creating unnecessary obstacles to international trade.  
2.9.  The representative of Australia  provided the following statement. Australia notes that the 
primary focus of China's draft Provisions for Cosmetics Registration appears to be cosmet ics 
produced domestically in China. We would be grateful if China could clarify whether these proposed 
measures will apply to imported cosmetics. These provisions contain a number of references to 
requirements in other regulations, standards and technical specifications, for example: Article 42 
notes that people should follow the requirements of standards, technical specifications and 
registration inspection regulations; and Article 68 requests compliance with mandatory national 
standards and technical spec ifications. Australia requests that China provide further clarity and 
details on the requirement for filing imported cosmetic products. In particular, we request a copy of 
the standards, technical specifications, registration inspection regulations and man datory national 
standards that are mentioned in this draft. In line with our mutual WTO obligations, Australia 
requests that China notify the WTO and supply WTO Members with a copy of the mandatory national 
standards and other national laws, regulations, r ules and technical specifications mentioned in this 
draft. This will provide greater clarity and certainty for businesses and assist all WTO Members to 
better assess the potential impact of these measures on trade.  
2.10.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Japan, Korea, the United States, and Australia. The notified draft 
contains rules for the implementation of the new CSAR. The EU find s this implementing legislation 
clear and consistent with the CSAR principles. The EU is of the opinion that the clear steps outlined 
in the implementing rules can lead to a faster and more efficient registration and filing mechanism. 
In particular, the ob ligation for reviewers to identify mistakes and applicants to answer questions at 
once will avoid the current practice of repeated, time -consuming question -answer loops during 
applications. However, the EU would like to underline that certain requirements go beyond the CSAR 
principles in a way that they would create problems for the operation of cosmetic companies, 
including both domestic manufacturers and importers. Since the NMPA new filing and registration 
requirements are more extensive than what was re quired previously, the EU is concerned more 
information may be required than necessary (including disclosure of CBI) to access China's cosmetics 
marketplace. In addition, some requirements are not entirely clear from the notified text and the EU 
would appr eciate further clarification in particular on the concerns raised by the EU in its comments 
sent to the WTO on 19 October.  
2.11.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
China's endeavours to modernize its regulato ry system for cosmetics and also welcomes the 
opportunity to comment on China's proposed cosmetics measures notified under 
G/TBT/N/CHN/1454 . While we welcome the direction to improve safety and quality assurance, New 
Zealand would like to encourage China to ensure that facilitati on of trade is considered in the design 
of the regulations. New Zealand holds concerns, that we understand are shared by a number of 
countries, around issues such as having more detailed disclosure of formulas than is required in 
other markets, including s pecific sources of each ingredient, and not accepting certification that is 
accepted in other markets. New Zealand requests that China also provide further clarity on the 
proposed testing measures and encourages China to clarify in the regulation that test  reports can 
be accepted from accredited laboratories situated outside of China. We would also appreciate further 
clarification on what standards registered products should comply with. We respectfully remind China 
of its obligation to accept international  standards where appropriate, including aligning its national 
standards with relevant international standards. New Zealand looks forward to engaging further with 
China on this matter to better understand the requirements of the proposed measures. This will  
enable New Zealand and other WTO Members to assess in greater detail the potential impact on 
trade of these measures.  
2.12.   In response, the representative of China  provided the following statement. According to 
scientific researches, there are certain differen ces in skin texture between different people. In 
practice, Chinese competent authorities have also found significant differences between sunscreen 
index reports of sunscreen products issued by Chinese laboratories based on Chinese subjects and 
the ones iss ued by other Members' laboratories. In order to protect legitimate rights and interests 
of consumers and ensure the accuracy of inspection results, China has proposed the requirement 
that the efficacy inspection of special cosmetics should be completed at the cosmetics registration 
and filing inspection agencies. However, China has not prohibited foreign inspection agencies from 
being cosmetics registration and filing inspection agencies. At present, many laboratories from G/TBT/M/82  
 
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  foreign inspection agencies locate d in China have achieved China Metrology Accreditation (CMA) 
certification in the field of cosmetics and have undertaken cosmetics registration and filing 
inspections. Therefore, we hold the opinion that China has not placed discriminatory treatment in 
cosmetics inspection.  
2.1.2.2   China - Administrative Measures on Cosmetic Labelling (IMS ID 6423) 
2.13.   The representative of Japan  provided the following statement. Regarding China's draft of the 
"Administrative Measures on Cosmetic Labelling " published on 21 September 2020, Japan 
appreciates China's consideration of our concerns on "Cosmetics Supervision and Administration 
Regulation ". However, Japan would like to express the following concerns: Article 5 provides that 
the content of the added  Chinese labels, such as information regarding product safety and efficacy, 
shall be consistent with the original labels. However, the original labels are designed to comply with 
regulations in the country of production and it is natural that their content s do not always comply 
with China's regulations. Therefore, Japan would like to request China that such requirement does 
not apply to labelling contents required by regulations in the country of production, and that the 
requirement will not be more trade r estrictive than necessary to fulfil legitimate objectives.  
2.14.   Regarding Article 6, in order to avoid confusion for consumers, Japan would like to ask China 
that the label indicate a single responsible person ( "cosmetics registrants or filers " or in the case o f 
imported products, "responsible person in China"), and we consider that the label requirements 
regarding producers is not necessary. With respect to the rules for labelling of all ingredients in 
cosmetics, there is an internationally recognized listing p ractice that ingredients with a compounding 
amount of 1% or less are allowed to list in no particular order. However, Article 12 provides that 
only ingredients with a compounding amount of 0.1% or less are allowed to list in no particular 
order. Japan woul d like to request to China that the rules for labelling should follow the 
internationally recognized practice so as not to be more trade restrictive than necessary.  
2.15.   Article 19 provides that the indications as "evaluated and verified efficacy" could be put on 
products only if the efficacy is confirmed by the qualified testing laboratory in China. Japan would 
like to request to China that the requirement be removed, since all efficacy indications have been 
verified based on scientific evidence regardless of w hether they are confirmed by a testing laboratory 
in China or not. As "Cosmetics Supervision and Administration Regulation " and its implementing 
regulations will cause great change, reasonable transition time is necessary to ensure business 
continuity. Jap an would like to request that China provide an adequate grace period, at least one 
year after promulgation of all relevant regulations in order to allow time for producers to adapt to a 
new cosmetic regulatory system. In addition, Japan would like to reque st that products on the 
market could be sold until the expiration date for use even after the grace period.  
2.16.   The representative of the Republic of Korea  provided the following statement. Cosmetics 
labels play a crucial role in providing consumers with not o nly instructions and precautions for use 
but also the list of ingredients, net content and manufacturer or distributor information, among 
others. Recognizing the importance of managing cosmetic labels, China revised the Administrative 
Measures on Cosmetic Labelling in September 2020 to set the labelling requirements, and Korea 
expresses full support for the efforts. However, Korea echoes the comments by Japan and would 
like to share concerns over a few provisions in the draft revision that may create trade barriers. With 
respect to imported cosmetics bearing Chinese over -labels, the Regulation requires the information 
regarding product safety and efficacy claim on the over -labels to be consistent with that on the 
original label. Each country has its own rule s and regulations. The contents of the label required by 
the regulation of the country of origin could be prohibited under the revised measure for labelling 
regulation. To address this issue, Korea would like to ask China if it could allow indicating an 
explanation for the inconsistency on the over -label.  
2.17.   Regarding Article 12, Korea invites China to maintain its current regulation on the declaration 
of the ingredient list and colorants in cosmetics on the labels. The requirement under Article 12 
seems to be  inconsistent with the international practice. The rationale for such revision also remains 
unclear to Korea. For example, some ingredients may produce a significant effect even at a 0.1% or 
lower concentration. However, indicating the content of such ingr edients as "other ingredients in 
small amounts " may mislead a consumer to believe that the ingredients have no efficacy. Also, we 
request that China exempt the declaration of the substances added to a cosmetic during manufacture 
 
3 For previous statements follow the thread under IMS ID  642 (under dates raised and references) . G/TBT/M/82  
 
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  but present in the finished  cosmetic at an insignificant level and not having any technical or functional 
effect in that cosmetic. Article 14 stipulates that when cosmetics are marketed as multi -unit or multi -
component packages, the earliest expiration date of all units or component s should be declared on 
the label of the outer packaging. However, in some cases, expiration dates must be declared on the 
individual multi -unit or multi -component packages. Thereby, Korea requests China to allow the 
declaration of expiration date on the p ackaging of each unit or component. The regulation requires 
that efficacy claim evaluation reports contain information including the purpose of verification, 
verification method, results, and conclusion. We call for China to consider that such information 
include a number of trade secrets and exclude them from the scope of information for disclosure. 
According to Article 21, China prohibits the use of labelling or efficacy claims using terminology and 
mechanism that are not widely accepted in the scientific  field. We kindly ask China to provide the 
definition, objective and rationale for the measure. We request that China provide sufficient 
transition period for stakeholders to comply with the requirements in these regulations. According 
to our understanding , the regulations are currently under an internal commenting process. Korea 
urges China to notify them to the WTO at the earliest opportunity to allow the Members to submit 
comments.  
2.18.   The representative of Australia  provided the following statement. Austral ia understands that 
China has recently drafted new Administrative measures on Cosmetics Labelling. In line with our 
mutual WTO obligations, Australia requests that China notify the WTO and supply WTO Members 
with a copy of these new administrative measures . Australia also requests that China provide WTO 
Members with an opportunity to comment on the measures before they are finalized.  
2.19.   The representative of the United States  provided the following statement. The United States 
would like to support the delegat ions of Japan, Korea, the European Union, and Australia. The United 
States similarly requests that China promptly notify the draft Administrative Measures on Cosmetics 
Labelling to the WTO, allow reasonable time for stakeholders to comment, take such comme nts into 
account before the measures are finalized, and provide for a reasonable transition period after 
adoption.  
2.20.   The representative of the European Union  provided the following statement. The European 
Union would like to support the delegations of Japan,  Korea, the United States, and Australia. The 
EU welcomes the on -going efforts by the Chinese authorities to draft implementing legislations that 
will transform the principles of the new CSAR into practical, actionable requirements. The EU 
understands that  China has recently drafted new "Administrative Measures on Cosmetic Labelling ". 
In line with our mutual WTO obligations, the EU requests China to notify the WTO and to provide 
WTO Members with an opportunity to comment on the notified measures before they  are finalized. 
The EU would like to make already today some general remarks on these draft measures that were 
subject to a public consultation in China until 20 October 2020.  
2.21.   The EU welcomes the continued possibility to apply international practice to ove r-sticker label 
with a sticker. The proposed draft measures require "consistency " between the safety and efficacy 
information printed on the original packaging and the sticker added as the Chinese label. The 
interpretation of "consistency" is, however, not  entirely clear and could lead to difficulties in the 
practical application processes for new products. In particular for product claims, the EU considers 
important that the actual wording takes into account the cultural and linguistic background of the 
consumer. Certain product claims may be considered as important in the country of origin, but may 
not resonate with Chinese consumers. Therefore, "consistency" between the original label and the 
Chinese sticker should not necessarily equate a "verbatim trans lation". Obviously, such practice 
must not be used to circumvent labelling restrictions set under the Chinese legislation.  
2.22.   It is also important to remind that differences between the original label and the Chinese 
sticker are sometimes caused by different mandatory labelling requirements between the country of 
origin and China (e.g. different rules for expressing the results of UV protection tests as "SPF 
numbers" on the packaging). As regards the proposed requirement on printing of the hygiene permit 
numbe r on the inner packaging, the EU is of the opinion that this should not be necessary for product 
identification or traceability. For in -market control purposes and consumer information, it is sufficient 
that the information is available on the visible oute r surface of the product. To our knowledge, no 
major trade region in the world requires this type of labelling of the inner packaging and such 
requirement would bring China in a non -compatible situation with the rest of the world. The EU 
would therefore as k the Chinese authorities to consider removing the requirement to show the 
registration number and Chinese product name on the inner packaging.  G/TBT/M/82  
 
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  2.23.   Finally, yet importantly, the implementation of the new labelling rules will require significant 
adaptation by c ompanies. In order to ensure a smooth transition and avoid the disruption of supply 
of safe and efficacious products on the Chinese market, a sufficiently long transition period of 24 
months should be considered. A differentiated approach should also be co nsidered for products 
already on the market or currently undergoing registration or filing, and products newly introduced 
to the market. Experience from the EU shows that it is beneficial to have a certain period of time 
during which the old and the new re quirements run in parallel and companies can "phase in " their 
products according to their priorities and resource constraints. The EU would also like to know when 
the drafting process of this measure will be finalized and when the text of the "Administrati ve 
Measures on Cosmetic Labelling " will be notified to the WTO.  
2.24.   The representative of New Zealand  provided the following statement. New Zealand would like 
to join other Members in raising concerns regarding the notification of this measure. New Zealand 
respectfully asks that China notify this measure to the WTO TBT Committee, in accordance with WTO 
transparency obligations. Like others, New Zealand requests that a copy of the draft measures be 
made available to WTO Members and that a reasonable period of ti me be provided for Members to 
submit comments, before the measures are finalized.  
2.25.   In response, the representative of China  provided the following statement. At present, the 
competent authorities are preparing for notification of the "Administrative Measure s on Cosmetic 
Labelling" according to procedures. Members are welcomed to comment on that notification.  
2.1.2.3   Kingdom of Saudi Arabia, Kingdom of Bahrain, State of Kuwait, Oman, Qatar, 
Yemen, United Arab Emirates - Halal Feedstuff, G/TBT/N/ARE/474 , G/TBT/N/BHR/574 , 
G/TBT/N/KWT/532 , G/TBT/N/OMN/407 , G/TBT/N/QAT/570 , G/TBT/N/SAU/1134 , 
G/TBT/N/YEM/176  (IMS ID 6434) 
2.26.   The representative of the United States  provided the following statement. The United States 
requests clarification from Gulf Cooperation Council (GCC) members and Yemen on the recent 
notification of a Halal feed measure. The United States is unaware of any other country establishing 
technical regulations for Halal animal feed; thus, this regulation would set a precedent if 
implemented. The proposed regulation requires that Halal feedstuff must either come from 
vegetative sources or animals slaughtered in  accordance with Islamic Sharia law. The United States 
also notes that, based on analysis of trade data, most countries that supply animal feed to GCC 
Members are not Muslim countries with the national framework in place to meet these criteria. On 
10 July 2020, the United States submitted comments on this measure to notifying WTO Members. 
We look forward to receiving substantive replies to our comments.  
2.27.   The United States would like to emphasize the trade -restrictive nature of this notified draft 
measure on the impact of trade in feedstuffs. The United States requests that the GCC provide 
additional details on this measure. For instance, would meat and poultry producers be required to 
feed Halal feedstuff to their livestock? The national standards cited in th e proposed regulation are 
BRUNEI DARUSSALAM STANDARD HALAL FOOD PBD24: 2007 and MALAYSIAN HALAL STANDARD 
(MS1500:2004.) Can GCC members explain how these standards are relevant to the proposal or 
how the proposal intends to use these standards to cover fee dstuff? We ask that GCC member states 
provide greater clarity on the intended scope of this measure, as well as the type of oversight 
envisioned. How would the GCC member states and Yemen conduct oversight and apply control 
systems imported animal feed to ensure adherence to this draft technical regulation? Can GCC 
members explain the implementation schedule for this measure? Given the potentially trade -
restrictive nature of this measure, the United States encourages officials from the GCC member 
states and  Yemen to set up dedicated technical exchanges with all interested private sector 
stakeholders and trading partners prior to considering requirements and application of a measure 
on Halal feedstuffs.  
2.28.   The representative of the European Union  provided the fo llowing statement. The European 
Union would like to thank the GCC countries and Yemen for providing an opportunity to WTO 
Members to comment on the draft GCC Technical Regulation on Halal Feedstuff and refer to its 
written comments of 12 June 2020. The Eur opean Union would also like to thank to the Kingdom of 
Saudi Arabia for the recent reply to the EU written comments. The reply seems to confirm that the 
use of Halal feedstuff would be a condition for imports of animal products certified and labelled as 
 
4 For previous statements follow the thread under IMS ID  643 (under dates raised and references) . G/TBT/M/82  
 
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  Halal. In this regard, the European Union would like to ask the GCC countries and Yemen to abstain 
from requiring the use of Halal feedstuff for animals reared in non -GCC countries and Yemen as a 
condition for the imports into the GCC countries and Yemen of Halal-certified animal products for 
human consumption. Such condition would require an alteration to the feeding regime for food -
producing animals in the EU and would negatively affect EU exports. The European Union appreciates 
that the Kingdom of Saudi Ar abia in its recent written reply provided explanations on the planned 
oversight and control systems to ensure compliance with the standard and on applicable certification 
requirements. Following the analysis of the reply, the European Union might ask for f urther 
clarifications in this respect.  
2.29.   In response, the representative of the United Arab Emirates  provided the following statement, 
on behalf of  the Kingdom of Saudi Arabia, the Kingdom of Bahrain, the State of Kuwait, Oman, Qatar 
and Yemen. The Kingdom o f Saudi Arabia would like to thank the United States and the European 
Union for their valuable comments and is pleased to clarify the matter related to these comments. 
Our response to comments from the United States and the EU has been sent to their respec tive TBT 
Enquiry Points. To date, the draft is under review at the level of the GCC Standardization 
Organization (GSO) technical committee. Your comments will be taken into consideration. 
Furthermore, Saudi Arabia would like to invite interested Members to  discuss this matter bilaterally.  
2.1.2.4   China - Commercial Cryptography Administrative Regulations (IMS ID 6445) 
2.30.   The representative of the United States  provided the following statement. The United States 
has concerns regarding China's draft Commercial Cryptogr aphy Administrative Regulations, issued 
by the State Cryptography Administration on 20 August 2020 and we submitted comments to China 
in September 2020. The United States is concerned that this draft measure would impose potentially 
far-reaching, highly tr ade-restrictive cryptography -related constraints on foreign information and 
communication technology (ICT) products. Does China intend to notify this measure to the TBT 
Committee and allow for additional stakeholder comments? The provisions in the draft me asure may 
raise serious concerns under the WTO agreements, and appear to conflict with globally -accepted 
practices to assess encryption in commercial ICT applications. We understand that China has 
received numerous comments on this draft. We hope that Chin a will carefully consider the input 
from all stakeholders, including the US Government and our industry stakeholders, and make 
substantial changes and clarifications to the draft measure prior to implementation.  
2.31.   The draft measure would establish a licensing scheme for all imports and exports of 
commercial cryptography in instances where "social and public interests " are concerned. Can China 
explain how it plans to implement this scheme in line with its national tr eatment commitments? 
What steps is China taking to ensure the scheme will be not operated as an unnecessary obstacle to 
trade? Given China's TBT obligations in Article 5, what steps is China taking to ensure its 
cryptography accreditation, testing and cert ification system will operate in accordance with Article 5 
of the TBT Agreement? Specifically, how will China ensure that the conditions for foreign products 
are no less favourable than those accorded to domestic products? Although the draft measure 
ostens ibly encourages participation in "the development of international standards for commercial 
cryptography, " Articles 10 to 12 appear to mandate compliance with Chinese standards, which may 
diverge from international standards. In addition, the draft measure  includes a standards -setting 
process for commercial cryptography that appears to provide a different level of openness to 
domestic participants as compared to foreign participants. In the United States' view, China should 
adopt and use relevant internatio nal standards and harmonize its practices with relevant 
international best practices. We would appreciate any update you can provide today on the status 
of the draft measure, and how China intends to consider the public comments it received.  
2.32.   The representa tive of Canada  provided the following statement. Canada provided comments 
on 17 September 2020 to China's State Cryptography Administration, on the draft revised 
Regulations on the Administration of Commercial Cryptography promulgated on 20 August 2020. 
We look forward to receiving a response. As indicated in these comments, Canada would appreciate 
China's consideration of modifying the regulations to provide further clarity, transparency and 
predictability by: (i) defining what products involving "national  economy", "people's livelihood" and 
"the public interest" are; (ii) clarifying that international standards will be the basis for China's 
commercial cryptographic technical regulations; (iii) supporting the creation of equitable standards 
by indicating th at all stakeholders can participate in the creation of commercial cryptographic 
 
5 For previous statements follow the thread under IMS ID  644 (under dates raised and  references) . G/TBT/M/82  
 
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  standards; and (iv) indicating whether, along with commercial cryptography, core and ordinary 
cryptography, as defined in China's Cryptography Law, will also be subject to new regulations. 
Canada expressed support for the substantive comments made by the US and the EU previously and 
would further encourage China to notify the measure to the WTO TBT Committee, providing WTO 
Members and stakeholders the appropriate time to review and comment on the measure.  
2.33.   The representative of the European Union  provided the following statement. The EU is also 
concerned about this partial implementation measure of the Cryptography Law and sent comments 
to the State Cryptography Administration of the People's Republic of China (SCA) in September. 
Specifically, our concerns relate to (i) the scope of the law; (ii) the lack of clarity of concepts and 
precision of procedures; (iii) the protection of intellectual property; (iv) the imposition of pre -market 
and export controls; (v) the requirements around testing and certification; (vi) the imposition of 
additional "national security reviews"; and (vii) the use of domestic standards, along with the lack 
of meaningful access to pertinent Chinese standards  development organizations. The EU urges the 
SCA to address these concerns in the further development of the draft regulations in order to ensure 
that legal and regulatory requirements are based on a non -discriminatory basis, do not favour 
specific technol ogies, do not limit market access and do not lead to forced transfer of intellectual 
property. Additionally, the EU encourages the SCA to open up, in practice, the "Cryptography 
Industry Standardization Technical Committee" (CISTC) to foreign -invested indu stry based in China. 
The EU would appreciate its comments being taken into consideration and invites the SCA to notify 
the draft regulations to the TBT Committee.  
2.34.   In response, the representative of China  provided the following statement. In order to 
implem ent the requirements of promoting administration in accordance with the law, and to deepen 
the reform of "streamline administration and delegate powers " in the field of commercial 
cryptography, China is revising the Regulations on the Administration of Com mercial Cryptography 
in accordance with the legislative spirit of the Law on Cryptography. The revision of the Regulations  
follows the principles of law -based, open, transparent and on a scientific basis. Besides, China will 
solicit opinions widely and ens ure the stakeholders' participation in legislative activities through legal 
means.  
2.1.2.5   Mexico - Decree amending, supplementing and repealing various provisions of the 
Regulations on Sanitary Control of Products and Services and the Implementing 
Regulations to the General Law on Health with Respect to Advertising, 
G/TBT/N/MEX/468 , G/TBT/N/MEX/468/Add.1 , G/TBT/N/MEX/468/Add.1/Corr.1  (IMS 
ID 6456) 
2.35.   The representative of the United States  provided the following statement. The United States 
appreciates Mexico's notification of its amendments to the Regula tions on Sanitary Control Products 
and Services and Implementing Regulations to the General Law on Health with Respect to 
Advertising, as notified in G/TBT/N/MEX/468 . The US Government and several US industry 
stakeholders provided comments to this notification by the comment deadli ne. We look forward to 
hearing responses to some of our questions from Mexico. While we support Mexico's efforts to reduce 
obesity and diet -related non -communicable diseases (NCDs), we are concerned that Mexico's 
proposed measure on nutrient fortification and advertising may be more trade restrictive than 
necessary to meet Mexico's legitimate objective, may not be based on robust scientific evidence, 
does not appear to consider the relevant international standards, and may limit the availability of 
fortifie d food options to meet consumers' dietary needs. Article 161 of the Decree appears to prohibit 
the voluntary nutrient fortification of "pre-packaged foods and non -alcoholic beverages with the 
nutrient profiles established for the front -of-pack warning labe lling" as defined under NOM -051 
(notified as G/TBT/N/MEX/178/Add.13) . On 10 September, CONAMER  (Comisión Nacional de Mejora 
Regulatoria ) published a revised version of this draft regulation that did not include Article 161 
fortification restrictions contained in the 3 June draft regulation. Can Mexico confirm that Article 161 
fortification restrictions will not be included in the final decree?  
2.36.   In addition, the proposed measure appears to have the effect of limiting certain types of 
positive claim labe ls on products required to carry a warning label under NOM -051. We urge Mexico 
to consider the potential impact of its proposal to ban these sorts of claims on products that carry a 
warning label and to clarify whether it intends to limit nutrient content claims or other positive health 
claims on packages carrying warning labels. The proposed measure also appears to require that 
 
6 For previous statements follow the thread under IMS ID  645 (under dates raised and references) . G/TBT/M/82  
 
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  advertising of pre -packaged food and non -alcoholic beverages that carry warning labels under NOM -
051 shall not include "characters , animations, cartoons, celebrities, athletes or pets, interactive 
elements, such as visual -special games or digital downloads, " that promote their consumption. 
Trademarks play an important role in commerce by allowing companies to distinguish their produc ts 
in the market and preventing consumer confusion. The United States notes that industry and a 
market research firm estimate the requirement of NOM -051 will apply to over 80% of food products 
on grocery store shelves in Mexico. It is our understanding tha t a wide variety of foods that the 
public may consume to reach their recommended daily intake of beneficial nutrients, such as 
yogurts, cereals, orange juice, bread, and canned beans, may be prohibited from voluntary 
fortification under this proposed measu re. Given the significant implications of this regulation for 
producers of packaged foods and beverages, and the complexity of each one of these additional 
restrictions on claims, advertising , and possibly fortification we request  that Mexico allow an 
extended implementation period for proposed changes to its fortification and advertising regulations 
to allow sufficient time for consultations with stakeholders and to fully consider comments from 
stakeholders, including trading partners.  
2.37.   The representative o f the European Union  provided the following statement. The European 
Union would like to thank Mexico for the possibility to send written comments on the notification 
G/TBT/N/MEX/468  and for the useful bilateral exchange. Firstly, the EU appreciates that the draft 
Article 161 was re moved in the revised version of the draft amendment to Regulations on Sanitary 
Control of Products and Services, submitted to public consultation on 10 September 2020. The 
removed draft Article 161 prohibited the addition of nutrients to unprocessed or fre sh foods, as well 
as to pre -packed foods and non -alcoholic beverages that meet the nutritional profiles established 
for the front -of-pack warning labels. The EU would like to ask Mexico to confirm that this provision 
will not be included in the final amend ment. Secondly, with regard to draft Articles 11 bis and 25 Bis 
3, the EU would like to ask Mexico to clarify the necessity of including precautionary indication on 
the label for additives and ingredients that are subject to the pre -market risk assessment and 
authorization, which should address the risks for consumers' health. In addition, the EU would like 
to ask Mexico to clarify the process and parameters for the determination of additives, ingredients 
or substances that would require a precautionary ind ication.  
2.38.   The representative of Colombia  provided the following statement. Colombia supports and 
shares Mexico's objective of informing consumers clearly and truthfully of the content of critical 
nutrients that present health risks if consumed to excess . However, we would like to express our 
support for the trade concern raised by the United States regarding the "Decree amending, 
supplementing and repealing various provisions of the Regulations on Sanitary Control of Products 
and Services and the Implementin g Regulations to the General Law on Health with Respect to 
Advertising ". Colombia submitted comments prepared by our industry on the draft measure through 
the information service . It regrets that no account of the comments made has been t aken in the 
final measure, a nd we therefore  reiterate the following concerns of our industry:  The health 
regulation  include s definitions on front -of-pack warning labels, critical nutrients and portion size.  
The Ministry of Health, in coordination with public and private research and higher education 
institutions, will establish food and non -alcoholic beverage portion  sizes as benchmarks. 
Pre-packaged food and non -alcoholic beverages should only include front -of-pack warning labels 
provided for in the corresponding regulation , with  no other labelling used . Nutrients may not be 
added to pre -packaged foods and non -alcoholic beverages that meet the nutritional profiles 
established for front -of-pack warning label ling except for those where there is a  requirement to do 
so. 
2.39.   Advertising of products with warning labels:  Must include the stamps and wording of NOM -51. 
May not include children's  animated or cartoon characters, such as special visual  games or digital 
downloads, aimed at enticing , promot ing or encourag ing children to consum e, purchase or ch oose 
the products  concerned. In this regard, Colombia considers that the above restrictions should not 
be established for the following reasons:  The inten tion is to establish legislative actions, going 
beyond  their purely regulatory purpose . They do not stem  from a higher regulation. They grant 
powers to the health authority  that should go to other authorities.  They violate the Mexic an free 
competition regime.  They infringe  the protection of intellectual property rights . The regulations are 
not a legal instrument from which rights must emanate or restrictions be created.  The scope of the 
regulations is unclear, causing considerable uncertainty for the inspection, surveillance and control 
proce ss. The authorizations granted by the State concerning  components, raw materials, ingredients 
and additives  are unknown . They constitute restrictions on the right of consumers to be well 
informed.  Significantly restricting the fortification of packaged foo ds could have unintended G/TBT/M/82  
 
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  consequences for the micronutrient intake of the population.  The voluntary fortification of food is 
internationally recognized by the World Health Organization as an effective contributor to public 
health . 
2.40.   They are more trade restr ictive than necessary to fulfil the objective  of improving public 
health , in violation of Article 2.2 of the TBT Agreement , which 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 obstacles to international trade . For this purpose, technical regulations shall 
not be more trade -restrictive than necessary to fulfil a legitimate objective ". In light of the above, 
Colombia respectfully requests Mexico to undertake a review of the regulation issued and to take 
into account the comments submitted in the framework of international public consultations a nd to 
grant a reasonable period of time in line with industry norms, to enable enterprises to make the 
adjustments in the production process that are required under the regulation, with a minimum of 
two years . 
2.41.   The representative of Chile provided  the following statement. Chile thanks Mexico for the 
information provided in notification G/TBT/N/MEX/468 , G/TBT/N/MEX/468/Add.1  and 
G/TBT/N/MEX/468/Add.1/Corr.1 . Also, concerning the publication in the Official Journal of the 
"Agreement establishing criteria for the implementation, verification, monitoring and conformi ty 
assessment of the Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -2010", this 
establishes that the use of adhesives or stickers should not be prevented , as long as they meet all 
the commercial and health information requirements stipulated in t he Amendment. This applies until 
31 March 2021. In other words, during phase one, from 1 October 2020 to 31 March 2021, adhesives 
or stickers may be temporarily used on product labels.  In this regard, I wish to reiterate that the 
use of adhesives is a matt er of ongoing interest, based on Chile's national and international 
experience, as regards the permanent application of this mechanism, with the single objective of 
complying, on the one hand, with the legitimate aims of public policy and, on the other, of  preventing 
an unnecessary barrier to trade. Chile reiterates its interest in Mexico considering the permanent 
use of adhesive stickers and transfers.  
2.42.   In response , the representative of Mexico  provided the following statement. The delegation 
of Mexico than ks the United States and the European Union for sharing their comments regarding 
the notification through which the Decree amending, supplementing and repealing various provisions 
of the Regulations on Sanitary Control of Products and Services and the Impl ementing Regulations 
to the General Law on Health with Respect to Advertising was amended, which was notified for public 
consultation on 6  July 2020 in document G/TBT/N/MEX/468 . With respect to the statements shared, 
I would like to make the following remarks.  As regards the conce rns relating to Article  161, the 
delegation of Mexico confirms that the amendment to this Article was removed. The amendment 
provided for the restriction on the addition of nutrients in those pre -packed food and non -alcoholic 
beverages that complied with t he nutritional profiles established for front -of-pack advisory labelling 
set out in NOM -051, which only applies to pre -packed food and non -alcoholic beverages with added 
sugars, fats or sodium.  However, it is worth underlining that the restriction on addin g nutrients to 
unprocessed or fresh food has been applicable in Article  161 since such regulations came into force; 
consequently, regardless of whether Article  161 is not amended as initially notified, the ban on 
adding nutrients to unprocessed or fresh fo od still stands.  
2.43.   Also, with regard to Articles  11bis and 25 bis 3, the inclusion of precautionary and warning 
messages is stipulated under Article  25 of the regulations in question as part of the mandatory health 
information that should be included in the l abelling of the products subject to those regulations. In 
this regard, the proposed amendment to Articles  11 and 25 bis 3 only seeks harmonization with this 
Article in order to achieve regulatory consistency.  Notwithstanding the above, as set out in Article  11 
and 25 bis 3, the corresponding technical regulations are those which would define the wording that 
must be included, depending on the type of product and on the basis of the ingredients or additives 
identified that may put at risk the health of consumers, for example:  NOM-201-SSA1 -2015. Products 
and services. Water and ice for human consumption, packaged and in bulk. Sanitary specifications; 
NOM-218-SSA1 -2011. Products and services. Non -alcoholic flavoured beverages, whether or not 
frozen, concen trated products for the preparation thereof, and beverages containing added caffeine. 
Sanitary specifications and provisions. Test methods; NOM -142-SSA1/SCFI -2014. Alcoholic 
beverages. Health specifications. Health and commercial labelling ; NOM -141-SSA1/SC FI-2012. 
Labelling of pre -packaged cosmetic products . Health and commercial labelling; 
NOM-189-SSA1/SCFI -2002. Products and services. Labelling and packaging for hygiene products for 
household use.  Lastly, and regarding the questions on advertising, it is important to clarify that such G/TBT/M/82  
 
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  provisions are set out in section  4.1.5 of the amendment to NOM -051 published in its final form on 
27 March of this year. Although this technical regulation came into force on 1  October  2020, as 
regards the system of front -of-pack labelling, the other sections, including 4.1.5 (advertising), will 
enter into force on 1  April 2021, which will provide approximately one year for its compliance.  
2.1.2.6   India - Phase II of the Mandatory Testing and Certification of Telecommunications 
Equip ment (MTCTE), implementing the Indian Telegraph Amendment, 
G/TBT/N/IND/158 , G/TBT/N/IND/159 , G/TBT/N/IND/160  (IMS ID 6467) 
2.44.   The representative of the United States  provided the following statement. The United States 
understands that a 23 June 2020 notification published by India's Ministry of Communications, 
Department of Telecommun ications (DoT) introduced Phase II of the MTCTE regime, effective 1 
October 2020. Phase II expands testing and certification to three additional product categories: 
transmission terminal equipment; passive optical network family of broadband equipment; and  
feedback devices. Considering the scope of test requirements under the MTCTE; the complexity of 
the newly included Phase II categories; and factors, including the COVID -19 pandemic, which may 
impact product testing and certification timelines, the United States respectfully requests that India 
provide a minimum of one year for in -country testing and certification from the date of any MTCTE 
phase notification, including Phase II, such that the effective date for Phase II is no earlier than 23 
June 2021.  
2.45.   US industry notes that several products within the scope of Phase II have already been 
manufactured and placed on the Indian market. The United States requests that India allow the 
fixture of logo stickers on product packaging of these products to meet MTCTE labelling 
requirements. US industry also notes that only two laboratories in India have the capability to test 
the technical requirements outlined in the Indian Telegraph (Amendment) Rules, 2017. To avoid 
unnecessary delays, the United States urges India t o continue issuing provisional certificates; 
providing a validity period of two years for these certificates; and accepting requests for exemption 
for the technical requirements until enough laboratories are established. The United States 
understands that,  according to a 24 June 2020 addendum from the DoT, India will not accept test 
results from laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) 
signatories beginning 1 October 2020. If this is accurate, please explain the b asis of and justification 
for no longer accepting such test results. The United States requests that DoT allow for the 
submission of ILAC test results for an initial one -year period from the date of publication of any 
future phase of MTCTE.  
2.46.   The representat ive of Canada  provided the following statement. Telecommunications exports 
to India are an important Canadian interest. Canada appreciates the clarification provided by India, 
on its MTCTE program, in response to statements made at the May meeting of the C ommittee. We 
wish to emphasize the importance of providing adequate notice to suppliers of changes to testing 
requirements, as they must produce the product for testing, ship it to India and then wait for the 
product to be tested. Canada notes that, on 23 June 2020, India's Telecommunications Engineering 
Centre issued a notification8 that additional products would need to meet its new testing 
requirements, as of 1 October 2020. We also note that India's WTO notifications ( G/TBT/N/IND/158 , 
G/TBT/N/IND/159  and G/TBT/N/IND/160 ) were issued on 12 August 2020 and on an urgent basis 
and, consequently, provided no time for comments. We seek India's clarification of why these 
measures, applicable to products that have been on the market for some time, needed to be 
implemented with three -months notice on an urgent basis. In addition, Canada w ishes to reiterate 
its concern regarding India's movement away from accepting testing, for telecommunications 
equipment, in ILAC -accredited labs outside India and the cost of duplicative in -country testing. We 
note that accepting foreign test results, in a ppropriately accredited labs, is the least trade -restrictive 
manner of achieving legitimate safety and security objectives and seek India's agreement to 
continue this widely -accepted practice.  
2.47.   In response, the representative of India provided the following  statement. Considering the 
factors like COVID -19, etc., Phase II of MTCTE was launched with only three low -impact products. 
For these products, test results in respect of technical parameters were acceptable from laboratories 
accredited by ILAC signatorie s up to 30 September 2020. Extension of acceptance of test results in 
respect of technical parameters from laboratories accredited by ILAC signatories beyond 30 
 
7 For previous statements follow the thread under IMS ID  646 (under dates raised and references) . 
8 https://www.tec.gov.in/pdf/MTCTE/MTCTE_Phase2_240620.pdf  G/TBT/M/82  
 
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  September 2020, is under consideration. To ensure that the existing supply chain is not disturb ed 
and business continuity is maintained, the requirement of labelling on MTCTE certified products is 
exempted as a relaxation for an initial period of six months with effect from the date from which 
testing and certification for that telecom product is ma de mandatory in India. Regarding the 
provision for exemption of few test parameters, due to the inadequacy of testing infrastructure and 
the issue of a provisional certificate with a validity period of two years, it may be noted; this provision 
already exi sts in the MTCTE scheme. The equipment manufacturers are utilizing this provision 
already. Further, if the testing capability for a particular test parameter does not exist in the country, 
the exemption for that test parameter is granted, and a provisional  certificate with a validity period 
of two years is issued.  
2.48.   It may also be noted; the MTCTE scheme provides for acceptance of test results from 
laboratories accredited by ILAC signatories, by way of relaxation, till the time sufficient test capability 
is developed in the country. Testing capacity for the requirements outlined in the Indian Telegraph 
(Amendment) Rules, 2017, is reviewed from time to time. As adequate in -country testing capability 
exists for EMI/EMC and safety -related test parameters, relaxat ion for acceptance of test results from 
laboratories accredited by ILAC signatories in respect of EMI/EMC and safety -related test parameters 
ceased to exist after 31 March 2020. For technical parameters, acceptance of test results from 
laboratories accredi ted by ILAC signatories was available up to 30 September 2020. As testing 
capability regarding technical parameters is still not considered adequate, relaxation for acceptance 
of test results from laboratories accredited by ILAC signatories is under consid eration for extension 
beyond 30 September 2020.  
2.1.2.7   Zimbabwe - Electricity (Minimum Energy Efficiency Performance of Domestic 
Electrical Appliances) Regulations, 2020, G/TBT/N/ZWE/2  (IMS ID 6479) 
2.49.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of Zimbabwe to introduce energy efficiency regulations with a view to protect the 
environment and conserve energy resources. Furthermore, Korean companies  are fully committed 
to comply with the regulations of the Zimbabwe. On 10 July 2020, Korea sent official comments to 
the Zimbabwe Enquiry Point regarding this regulation, but Korea has not yet received a response 
from the relevant authority. Therefore, Ko rea requests Zimbabwe to review the following difficulties. 
First, according to Schedule I (Appliances Listing) of the regulations describing energy performance 
testing standards by products, as a result of checking the test standards for household refrige rator 
and air conditioner, there appears to be a mistake as the corresponding standards are non -existent. 
Therefore, Korea asks Zimbabwe to consider making changes by reflecting our suggestions proposed 
in the table below. Also, regarding ZWS 1008:2016, wh ich is the standard for testing induction cook 
stoves, Korea asks Zimbabwe to confirm whether this standard is present and is harmonized with 
international standards, and if so, please inform us as to how we may access this standard.  
2.50.   Second, the regulation specifies only standards for testing methods related to each product, 
but it does not specify specific requirements by products such as energy efficiency rating 
requirements, label designs, etc. In addition, due to the lack of inform ation for locally designated 
testing laboratories, the conformity assessment process and information for complying with Article 
7(1) which requires registration to the Zimbabwe Energy Regulatory Authority (ZERA), many Korean 
companies are facing difficulti es when preparing for exports. Therefore, Korea requests Zimbabwe 
to provide detailed requirements by products, the status of designated testing laboratories, the 
conformity assessment process and the guidelines for information registration to the ZERA. Th ird, 
Zimbabwe has announced that these regulations are scheduled to take effect on 1 February 2021, 
but this date leaves insufficient time to prepare for exports due to the lack of essential information 
for regulatory compliance as mentioned above. Therefo re, Korea requests Zimbabwe to delay the 
implementation of the regulations for a period at least six months after correcting the regulations, 
and providing essential information necessary to comply with the regulations.  
2.51.   In response, the representative of Zimbabwe  provided the following statement. ZERA  is still 
checking on all standards with a view to replac ing all non-existent  ones. With regard to Standard 
ZWS 1008:2016 we are reporting that this standard is based on the American standard ASTM F2834. 
We w ill also look into  the specific requirements by products such as energy efficiency , including their  
rating requirements, and also label designs. We will submit the conformity regulations SI 124  which 
provide the due process and also the guidelines.  We are a lso reporting that the r egulations will not 
 
9 For previous  statements follow the thread under IMS ID  647 (under dates raised and references) . G/TBT/M/82  
 
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  be effective in Feb ruary  2021. This is mainly due to the COVID -19 pandemic challenges . We will 
advise a gazetting date after the pre-implementation phase.  We are ready to engage with Korea 
bilaterally on this iss ue.  
2.1.2.8   Mexico - Various State Measures Restricting Sale of Food and Drink Products to 
Minors (IMS ID 64810) 
2.52.   The representative of the United States  provided the following statement. The United States 
is concerned about new measures in the Mexican States of O axaca and Tabasco, which ban the sale 
of foods and beverages, carrying high-in sugar , fat or calorie nutrition label(s) to children 18 years 
of age or younger. These state measures prohibit packaged foods and beverages as those products 
sold with added sug ar, saturated fats, trans fats,  and sodium exceeding nutrient thresholds, in 
accordance to the corresponding federal technical regulation, Official Mexican Standard NOM -051 
SCFI/SSA1 -2010 "Labelling for pre -packaged food and non -alcoholic beverages – Comme rcial and 
Health Information, as Mexico notified in G/TBT/N/MEX/17 8/Add.13 . We request Mexico notify these 
state-level measures to the WTO (and USMCA ). We requested notification on 18 August, through 
the US WTO/USMCA TBT Enquiry Point, at an early and appropriate stage, to allow for Member 
comments, and to allow state go vernments to take Member comments into consideration in their 
final measures.  
2.53.   State Registers  published notice of these measures in Oaxaca and Tabasco in August. We 
understand the Governor of Oaxaca approved the measure on 8 September, and an implementatio n 
plan is under development. We also understand the measure in Tabasco is awaiting the governor's 
approval. What is the timeline for implementing these measures? Are there other steps these states 
will take before implementation? Given the number of small retailers and vendors in Mexico, how 
would these measures be enforced? While the United States continues to support initiatives that 
advance the goal of promoting healthy dietary choices and lifestyles to children, we urge Mexico to 
consider whether it can  attain its public health goals through the use of less trade -restrictive 
alternatives. Preliminary industry and market research firms estimate that more than 80% of the 
pre-packaged foods and non -alcoholic beverages in Mexico will have at least one warnin g sign, 
meaning they could not be purchased or provided to minors except by a parent or guardian. We are 
concerned that these measures restrict anyone under the age of 18 from purchasing common 
groceries such as cheeses, bread, and some meat products, whic h lead to possible food security 
concerns. Can Mexico explain how it proposes to enforce such a broad sales ban?  
2.54.   We would like to note that sustained, healthy changes to diet behaviour and consumer 
preferences take time. We understand that 24 of the 31 sta tes in Mexico, plus Mexico City, are 
considering enacting restrictions. In addition, we learned via communications through our respective 
Enquiry Points that Mexico does not believe that state -level measures should be notified to the WTO 
TBT Committee, and  therefore does not plan to do so. In the United States' view, these measures 
form part of a larger package of measures that include federal -level technical regulations, and 
therefore should be notified to the WTO. Can Mexico explain why it believes the me asures should 
not be notified? Also, we understand that a proposal for a federal -level ban was introduced before 
Mexico's Senate on 21 September. Can you provide more information on the status of this proposal?  
2.55.   The representative of Colombia  provided the f ollowing statement. Colombia wishes to register 
its interest in this matter and will carry out a detailed review of the re lated information . 
2.56.   In response, the representative of Mexico  provided the following statement. The delegation 
of Mexico thanks the del egation of the United States for sharing its comments on the draft regulatory 
amendments in some States, which seek to prohibit the sale of some food and non -alcoholic 
beverages to minors.  The proposed state -level measures are part of the national strategy  aimed at 
combating public health issues in the country such as obesity and excess weight, both in adults and 
minors.  According to UNICEF11, overweight and obesity in Mexico are a problem occurring in infancy, 
that is, between 0 and 5 years of age. At leas t one in every 20 children under the age of five is 
obese, which makes them prone to being overweight for the rest of their lives and puts them at risk 
of suffering from, inter alia, circulatory, heart and kidney diseases and diabetes. The proportion of 
children suffering from overweight or obesity has increased to one out of every three. The main 
 
10 For previous statements follow the thread under IMS ID  648 (under dates raised and references) . 
11 https://www.unicef.org/mexico/sobrepeso -y-obesidad -en-ni%C3  per centB1os -ni%C3  per centB1as -
y-adolescentes  G/TBT/M/82  
 
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  nutritional problem suffered by children aged between 6 and 11 years is the presence of both 
disorders, obesity and overweight. As a consequence, Mexico is one of  the countries with the highest 
rate of childhood obesity in the world.  Furthermore, UNICEF states that the main causes of obesity 
and overweight in children are the consumption of processed food with high levels of sugar, trans 
fats and salt, as well as s weetened beverages, which are readily available given their wide 
distribution, low cost and promotion in the mass media.  
2.57.   As regards the points made by the delegation of the United States, and following an analysis 
carried out by the relevant authorities of  the Government of Mexico, the legislative amendments 
that have been adopted, to date in two states of the Republic of Mexico (Tabasco and Oaxaca), are 
not considered to meet the terms that would make them verifiable as a technical regulation under 
the def inition in the WTO Agreement on Technical Barriers to Trade and, therefore, the notification 
requirements stipulated therein are not applicable.  The link between such state measures and 
NOM-051 on the commercial and health requirements for the labelling of  pre-packed food and 
non-alcoholic beverages only refers to the scope of application, that is, it aims to prohibit the sale 
to minors of food and non -alcoholic beverages to which the requirements of NOM -051 apply. Also, 
no secondary legislation has been is sued on the implementation of the measures concerned, and 
consequently there is no information to share in this regard at this time.  The Government of Mexico 
reiterates its commitment to complying with the international commitments set out in the Agreement  
on Technical Barriers to Trade and those relative to the Free Trade Treaties of which Mexico is a 
member. However, it also reiterates its commitment to safeguarding the health of the Mexican 
people.  
2.1.2.9   India - Indian standards and import restrictions in the automotive sector (Quality 
Control Orders): wheel rims, safety glass, helmets, G/TBT/N/IND/118 , 
G/TBT/N/IND/147 , G/TBT/N/IND/167  (IMS ID 64912) 
2.58.   The representative of the European Union  provided the following statement. Recently India 
adopted a number of measures in the automotive sector that raised important concerns across the 
EU industry. These recent Indian measures - Quality Control Orders - in the automotive sector regard 
mandatory  markings for wheel rims, new standards for safety glass, and Bureau of Indian Standards 
(BIS) compulsory certification for helmets for two -wheeler riders. All three notifications from India 
foresaw only 30 days for comments. The EU takes this opportunity to recall that according to Article 
2.9.4 of the TBT Agreement, Members shall, without discrimination, allow reasonable time for other 
Members to make comments on notified draft technical regulations. Furthermore, in its 
recommendation G/TBT/9  of 13 November 2000, the TBT Committee agreed that the  normal time 
limit for comments on notifications should be at least 60 days. One month commenting period has 
proven too short for the EU to react before the final date for comments. The EU would like to 
underline that all measures in question appear to hav e protectionist orientation and are sending very 
worrying signals not only to EU industry, but also to EU investors and EU Member States. Once these 
measures come into force, they will cause extra burden and economic cost to the EU industry that 
will have to undergo cumbersome procedures to obtain necessary permissions and/or licences 
without any added value or scientific evidence that these measures would actually contribute to 
improved safety beyond the UNECE  framework.  
2.59.   As regards the wheel rims, the draf t Quality Control Order (QCO) issued by the Department 
of Heavy Industries (DHI) would make mandatory Indian Standards Institution (ISI) marking on all 
automotive wheel rims and would generate additional costs for the European automotive 
manufacturers. As per Order dated 21 September 2020 issued in Gazette of India, it stated that the 
Automobile Wheel Rim Component (Quality Control) Order 2020 shall come into force after one year 
from the date of its publication in the Official Gazette. The European Union w elcomes this decision 
by the Indian Government. The EU would like to ask India to reconsider the introduction of this QCO 
– to repeal it or to waive its application to EU trustworthy manufacturers. The EU believes that BIS 
markings should be optional for c omponents which are already in compliance with the current 
marking requirements as notified by the Ministry of Road Transport and Highways under the Central 
Motor Vehicle Rules (CMVR), and are either installed on new vehicles in accordance with UN 
Regulati on 142 concerning the approval of motor vehicles with regard to the installation of their 
tyres or are type approved as replacement wheels according to UN Regulation 124 concerning the 
approval of wheels for passenger cars and their trailers.  
 
12 For previous statements follow the thread under IMS ID  649 (under dates raised and references) . G/TBT/M/82  
 
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  2.60.   The European Union would like to thank Indian authorities for the decision to postpone the 
introduction of the mandatory ISI marking for automotive Safety Glasses to April 2021. According 
to the new QCO, originally scheduled to enter into force on 16 September 2020, au tomotive glass 
not mounted in vehicles (loose or spare parts) sold in India would have to obtain a new national 
licence and marking. Despite the much welcome delay of the entry into force, the European 
companies still face difficulties and delays in their preparation for the new certification system. Not 
all rules are clear in the new scheme, and the prohibition to travel from and to India due to the 
COVID -19 restrictions make this new scheme more difficult to implement, and there are still 
problems of dela ys due to the pandemic. While acknowledging the purpose of BIS licensing to 
guarantee the quality of safety glasses used in transport vehicles, in view of the current situation 
concerning the outbreak of COVID -19, it would be difficult for EU companies to comply with the new 
requirements within the deadlines set by the QCO. Furthermore, the new requirements may generate 
additional costs to EU automotive glass manufacturers, as they would require complex procedures 
such as audits, tooling changes, etc.  
2.61.   The E uropean Union would like to ask India to further delay the entry into force of this 
measure, so that the EU industry may fully comply with the Order. This would allow the EU 
companies to meet the requirements and to continue supplying customers in India. T he QCO on 
Protective Helmets for Two -Wheeler Riders is set to come into force on 1 March 2021. The EU would 
like to request India to keep the BIS marking as optional for components, which are type approved 
according to UN Regulation 22 concerning the appro val of protective helmets and of their visors for 
drivers and passengers of motorcycles and mopeds. The European Union finds these measures to 
be unproportionate and cause obstacles to trade. The European Union would very much appreciate 
if India could rec onsider the mandatory introduction of QCOs on the wheel rims, automotive safety 
glass, and helmets.  
2.62.   The representative of the United States  provided the following statement. The United States 
is aware that India recently adopted a number of QCOs in the aut omotive sector, which concern 
mandatory markings for wheel rims, new standards for safety glass, and compulsory certification 
with the BIS for helmets for two -wheeler riders. The United States supports the request that India 
provide at least 60 days for in terested stakeholders to provide comments on these QCOs, and that 
India take submitted comments into account before finalizing these QCOs.  
2.63.   In response, the representative of India provided the following statement. India wishes to 
inform the Members that th e testing and certification system for wheel rims in India is in line with 
the global regime. Component certification is an essential pre -requisite of Whole Vehicle Type 
Approval, and the two are complementary. This practice is well established worldwide a nd quite 
harmonized under Whole Vehicle Type Approval. In the European Union, wheel rim is not identified 
as a separate safety -critical component in UNECE. But in India, it is recognized as an individual 
safety component under CMVR, given the local road in frastructure, a variety of tyres used, and 
driving behaviour. Because of its crucial role in driving safety, Indian standards are prepared to 
ensure quality, reliability, and wheel rims consistency. These standards prescribe the general and 
performance req uirements of wheel rims intended for use on two, three, and four -wheeled motor 
vehicles. The QCO (automotive wheel rims) is non -discriminatory, both at the original fitment level 
of automobiles and after sales/repair service. It aims to ensure that the sup ply of only quality 
products in the Indian market is duly certified and approved by the Indian implementing agency. 
The QCO also provides market surveillance to check the entry of substandard products into the 
Indian market. The QCO was issued after due co nsultation with stakeholders. Further, as desired by 
the stakeholders, a sufficient lead time of one year from the date of publication of the Gazette 
Notification of the QCO has been provided for the industry to prepare itself. In reference to safety 
glass it submitted, the QCO in Safety Glass was issued on 12 March 2020, with 16 September 2020 
as the implementation date. On request, this date is now extended to 1 April 2021. Additionally, the 
order is amended on 18 September 2020, which currently states th at safety glass used in the vehicle 
imported in India by vehicle manufacturer under the provisions of rule 126 of "Central Motor Vehicle 
Rules, 1989" is not covered under QCO of safety glass. It may also be noted; there is no proposal 
to further extend the  QCO on safety glass beyond 1 April 2021.  
2.64.   As regards the helmets, India is the largest two -wheeler market in the world. Around 15 
million two -wheelers are sold in the country every year. Also, the fatalities due to road accidents, 
i.e., around 150,000 per year, are the highest in the world, about 11% of the total global road 
accident fatalities. And further, the deaths involving two -wheelers are a significant number, and 
deaths without helmets or with helmets of low quality are also very high. The Governmen t and the G/TBT/M/82  
 
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  Apex Court, i.e., the Supreme Court, focus hard on policies and measures to make people wear 
proper helmets while riding two -wheelers. In this regard, there was a move to reduce the maximum 
weight of the helmets so that people should use helmets,  and BIS, the Indian certification standard 
organization, had issued the notification in this regard, which has prescribed the maximum weight 
of helmets to 1,200 grams from earlier 1,500 grams. But due to the demand from the foreign helmet 
importers, the c ap on weight from 1,200 was extended to 1,500 grams. Now there is a proposal for 
including the helmet in the compulsory certification regime. This will ensure that the helmets are 
manufactured or imported only with the BIS standard specifications and would  ensure good quality 
helmets, which would provide adequate protection and cause fewer deaths. The BIS provides a 
mechanism for foreign manufacturers to obtain BIS certification, enabling them to sell in India. 
Considering India's road safety scenario above , which is quite different from any European country, 
certified helmets' requirements are a high priority.  
2.1.2.10   Russian Federation - Federal Law n° 468 on wine making and wine growing in 
the Russian Federation (IMS ID 65013) 
2.65.   The representative of the European U nion provided the following statement. Russia has 
adopted a measure "Federal Law Nº 468 of 27.12.2019 on wine making and wine growing in the 
Russian Federation". This measure has not been notified to the WTO. The Law entered into force on 
26 June 2020, onl y six months after its adoption, despite requests to postpone this date, including 
a joint letter by the EU, Australia, Switzerland and the US. We understand that the Ministry of 
Agriculture has very recently been appointed by decree as the supervising aut hority to oversee the 
implementation of this law. We are grateful to this Ministry for the technical meeting that took place 
on 14 October with the EU Delegation in Moscow. We hope that the Ministry will be able to engage 
actively with foreign stakeholders , who remain very concerned and provide the clarifications they 
need. The Law is already in force, but amendments to the Law (the so -called Bakharev's proposal) 
are being discussed by the Duma, which adds new uncertainties for foreign businesses who need t o 
adjust to the new regulatory environment.  
2.66.   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. inconsistency with 
International Organisation of Vine and Wine (OIV) labelling and winemaking rules, inspection of EU 
facilities by Russian officials, disqualification of wine -based products, use of EU Geographical 
indication names to define categories of wines in the law, such as Champagne and Cognac , by 
Russian domestic producers etc). We note the presence of a stock -exhaustion clause which only 
concerns products already in Russia before 26 June 2020 and wonder why it is linked to cumbersome 
rules to display products separately in shops. The EU is ve ry concerned that the Law will have a 
strong impact on import of foreign wines. We also note statements by the Russian Wine Federation 
that the declared objective is to drastically reduce imports in order to favour the development of the 
Russian wine secto r. In addition to the issues posed by the Federal Law itself, some of its 
requirements do not coincide, or even contradict, with the technical requirements set out in the 
EAEU Technical Regulation (TR) on safety of alcohol products, contributing to regulat ory uncertainty. 
For example the Federal Law states that for wine the content of ethyl alcohol must be between 7.5 
to 18%, whereas the EAEU TR sets the range between 8.5 to 18%. Our first question relates to the 
date of the entry into force of the EAEU TR in Russia. We understand from the EU Delegation that 
the date of implementation of the TR will be postponed by one year; could you please confirm? 
Secondly, we understand that the Ministry of Finance in cooperation with the Ministry of Agriculture 
will, ov er the coming months, work at harmonizing the Russian Law and the EAEU TR; is it correct? 
How will it work in practice to ensure that the two documents are in line? Will modifications be done 
only in the TR, only in the law or in both documents? Could this  harmonization phase be a good 
opportunity to correct also divergences with the international standards produced by OIV?  
2.67.   Discrepancies between the Russian Law and OIV provisions, on -going adoption of an 
amendment at the Russian Duma, discrepancies between provisions of the Russian Law and of the 
EAEU TR, postponement of the entry into force of the EAEU TR, work of the Ministries of Finance and 
Agriculture to remove discrepancies between the Russian Law and the EAEU TR; the dimensions  of 
regulatory uncertain ty are many, with significant impact on foreign producers. 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 me asure to the Council 
for Trade -related Aspects of Intellectual Property (TRIPS). The EU invites Russia to notify the new 
 
13 For previous statements follow the thread under IMS ID  650 (under dates raised and references) . G/TBT/M/82  
 
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  wine measure, under the TBT Agreement as well as under the TRIPS Agreement. Meanwhile, the 
European Union would like to ask Russia to p ostpone further effective implementation of the law 
pending these clarification  exercise, and to take these comments into consideration during the on -
going amendment  procedure.  
2.68.   The representative of Australia  provided the following statement. Australia und erstands 
Russia has adopted "Federal Law Nº 468 of 27.12.2019 on wine making and wine growing in the 
Russian Federation", which entered into force on 26 June 2020. The Federal Law poses several 
barriers to the importation of wine into Russia, which coupled  with the short timelines for the law's 
implementation, are of concern to the Australian wine industry. A key concern is the mandatory 
declaration of vintage and variety required under the new law. This does not reflect OIV practices, 
of which Russia is a member. Article 18 of Russia's Federal  wine law stipulates the start date of the 
wine ageing process as 1 January of the year following harvest, which puts Australian and other 
southern hemisphere producers at a distinct disadvantage given that the grape h arvest for these 
regions relies on a different biological growing season and harvest. That is, 1 January in the northern 
hemisphere is winter, whereas Australian and New World grapes are harvested early in the year, 
after 1 January. In relation to the agei ng process, Article 18 includes a category referred to as 
"brand " wine, which requires 18 months ageing following 1 January in the year following harvest. If 
this means wine cannot be given a brand unless it has been aged for 18 months, only Australian 
wine from 2018 and earlier would be permitted to carry a brand in Russia.  
2.69.   Article 24 prohibits the addition of water in wine, which poses a significant barrier to trade for 
New World growers. Australian food regulations permit the addition of water to dilute high sugar 
musts to aid fermentation. Minimal additions of water aids fermentation during periods of difficult 
seasonal conditions, including drought. Russia's Federal  wine law includes provisions covered by the 
Agreement on TRIPS, including geographical i ndications. Australia invites Russia to notify the 
measure to the Council for TRIPS accordingly. Additionally, Australia notes several obligations within 
the federal wine law are inconsistent with the Eurasian Economic Union Technical Regulation 
047/2018 "On safety of alcohol products ", which is expected to enter into force in January 2021. 
Australia seeks further clarification from Russia on how this regulation and Federal Law Nº 468 will 
be implemented once entered into force. Australia encourages Russia to take into account these 
concerns when reconsidering the implementation of the new Federal  wine law and we look forward 
to Russia notifying the WTO accordingly as soon as possible.  
2.70.   The representative of the United States  provided the following statement. The United States 
supports the request that Russia notify implementing measures to the WTO TBT Committee, provide 
at least 60 days for interested stakeholders to provide comments on the measure, and that Russia 
take submi tted comments into account before finalizing the regulations.  
2.71.   The representative of Chile provided the following statement. Chile would like to echo the 
comments made by the EU, Australia and the United States concerning this new Federal Law on 
wine. It re quests that Russia postpone the entry into force of the Law and that, in this regard, it 
submit the relevant notification to the WTO TBT Committee, so that comments may be submitted 
during a period of at least 60 days.  
2.72.   In response, the representative of th e Russian Federation  provided the following statement. 
We took note of the statements made by the EU, Australia, the US and Chile on this agenda item. 
Statements will be forwarded to the capital for consideration. Federal Law  on wine making and wine 
growin g was passed to develop wine making and wine growing industries taking into account 
obligations of the Russian Federation in the WTO. The requirements of this law are applied equally 
to both Russian and foreign products. On some of the specific issues rais ed today we have the 
following comments. With regards to EU's claims that the Federal Law uses cognac and champagne 
names to define categories of drinks, we would like to note that the Federal Law doesn't use the 
term "cognac" in its text. The term "champa gne" is used by the Federal Law only in a word collocation 
"Russian champagne " which denotes a subgroup of Russian wines. The term is applicable only to 
Russian wines produced in a special way and is not associated to the EU's Geographical Indication 
(GI) name. As explained on numerous occasions, champagne transformed into generic name in 
Russia and is not associated with the GI due to a long history of the use of this term in Russia. All 
wine producers have full range of rights that are not limited by the Federal Law to register their GIs 
and Appellations of Origins in the Federal Service for Intellectual Property and they are always 
welcome to do that. With regards to invitations to notify the Federal Law in TRIPS Council, we fail 
to see grounds set out in  Article  63 of the TRIPS Agreement for notification of the Federal Law. On G/TBT/M/82  
 
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  the claims of inconsistency of the Federal Law provisions with OIV labelling requirements, we note 
that we commented on some of them over previous TBT Committee meetings under agend a item 
"Russian Federation - Draft technical regulation on alcohol drinks safety ". So, on this we would refer 
to our statements made during November 2019 and February 2020 Committee meetings.  
2.1.2.11   India - Order related to requirement of Non -GM cum GM -free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (IMS ID 65114) 
2.73.   The representative of the United States  provided the following statement. The United States 
has serious concerns with India's new measur e mandating a "non-GM (genetically modified) origin 
and GM -free certificate " for certain agricultural imports to India, notified (as final) on 2 September 
2020 as G/TBT/N/IND/168 , with a proposed entry into force date of 1 January 2021. While we 
appreciate India's notification of t his measure to the TBT Committee, we note that there is a lack of 
clarity regarding the legitimate objective and scope of the measure, how the measure will be 
implemented or enforced, and how the measure fulfils the legitimate objective. India appears to b e 
implying that genetically modified foods are less safe than their conventional counterparts. India 
states in its notification the requirement of GM -free certificates is needed "to ensure that only non -
GM foods are imported into India ", and India's order explains the need for GM -free certificates in 
terms of "ensuring the safety and wholesomeness of article of foods imported into India ". The United 
States notes its concern regarding this justification and invites India to clarify these objectives. The 
certification requirements, contrary to India's claims, do not contribute to "ensuring the safety " of 
food imported into India. Many foods in global commerce have been evaluated in multiple countries 
with each country reaching the same conclusion of safety.  
2.74.   The United States notes that India's measure does not align with science - and risk -based 
decision making, creates certification requirements with which relevant national authorities may be 
unable to comply, and does not appear to consider relevant economic f actors, such as costs of 
compliance, or potential trade disruptions. The Government of India's requirements appear to apply 
to imports of all listed products, regardless of whether GM varieties of those products are in 
commercial production in the country of export. All Members exporting to India may encounter 
additional burdens to trade for those crops listed under Annex I of India's order. The Government of 
India has not clarified in writing whether the order applies only to imports intended for human 
consumption and whether the order applies only to raw, unprocessed products. The Government of 
India has also not laid out a process for relevant Indian authorities to make determinations regarding 
whether imported shipments are subject to the order. Given th e substantial uncertainty and the 
potential for significant disruptions to trade, we request that India withdraw this requirement and 
consider alternative approaches that are consistent with approaches of other Members to avoid 
creating unnecessary obstacl es to international trade. If India is unable to withdraw this 
requirement, we request that India explain the justification for the measure and provide any relevant 
international norms on which this measure is based.  
2.75.   The representative of Brazil  provided t he following statement. Brazil strongly supports India's 
commitment to ensuring high standards of health and safety for its population. Nonetheless, we 
would like to express concerns related to its recent order setting requirements of non -GM cum GM -
free ce rtificates accompanied by imported food consignments, notified as G/TBT/N/IND/168 . This 
regulation applies to 24 crops and requires official certification to attest that imported products are 
not genetically modified. Besides, certification must be issued for each cargo individuall y. The text 
of the regulation presents a template for the certificate to be issued by the competent authority of 
each country. India has not yet published any regulatory impact assessment, risk analysis, or 
technical document that presents the link between  said regulation and the legitimate objectives it is 
willing to safeguard. The lack of information regarding the scientific grounds for this regulation raises 
concerns about transparency in the regulatory process undertaken by Indian authorities. Neither h as 
India explained how this regulation relates to any relevant international standards for food safety 
and genetically modified organisms (GMOs), differing from obligations set under Article 5.12 of the 
TBT Agreement. The Indian regulation is expected to b e particularly harmful to Brazilian exporters 
of apples, cowpea beans, tobacco, sugar cane, and corn. Besides, the order establishes overly 
burdensome requirements for the so -called Competent National Authority, which would have to issue 
a certificate for every single consignment of the food products listed in the Annex. Despite providing 
a period for comments, the Indian Government has already set a date for entry into force of the 
regulation (1 January 2021), which raises concerns about India's compliance  with Article 2.9.4. of 
 
14 For previous statements follow the thread under IMS ID  651 (under dates raised and references) . G/TBT/M/82  
 
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  the TBT Agreement and about its willingness to actually take into account timely submitted 
comments. In light of the above, Brazil believes that regulation G/TBT/N/IND/168  is more trade 
restrictive than necessary to fulfil any legitimate objective under the scope of the TBT Agreement. 
We kindly ask India to reassess this draft measure. Moreover, could India please indicate the studies 
and the relevant international studies it relied upon in order to draft this regulation?  
2.76.   The representative of Colombia  provid ed the following statement. Colombia wishes to support 
the trade concern raised by Brazil and the United States regarding th e Order adopted on 
12 October  2020 by the Food Safety and Standards Authority of India  (FSSAI) , which is part of the 
country's Minis try of Health, which stipulates the requirement for a certificate demonstrating that 
imports of a list of 24 fresh fruit, vegetable and grain products are free from genetically modified 
organisms (GMO) . The certificate must be issued by the relevant  nation al authority of the exporting 
country.  We consider that the measure could restrict exports of certain fresh fruit s, vegetable s and 
grains to that market, as there is no clarity with respect to the legitimate objective pursued, its 
scope and the new require ments required by India . Furthermore, currently not all analytical 
techniques to check for genetically modified foods have been developed or certified, meaning that 
the measure may become an unnecessary obstacle to trade, violating Article 2.2  of the TBT 
Agreement, which 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 obstacles to 
international trade".  
2.77.   Moreover, regarding the time limits set out in notification G/TBT/N/IND/168  of 
2 September  2020, India stipulates in its regulation that the measure would enter into force on 
1 January  2021. In this respect, we wish to recall that, in accordance w ith Article 2.12 of the TBT 
Agreement, "Members shall allow a reasonable 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". This ensures  that both the relevant national authority and 
the productive sector may increase their technical capacity and make the corresponding 
docume ntary adjustments to implement a new procedure for the issuance of GMO -free certificates, 
which will certainly incur an additional cost for exporters . Such a situation creates uncertainty and 
possible major disruptions to trade . We support the requests for  India to withdraw this requirement 
and to consider other alternatives to avoid the creati on of unnecessary obstacles  to international 
trade.  Finally, Colombia thanks India for the opportunity to express its concerns on this issue.  
2.78.   The representative of Argentina  provided the following statement. Argentina would like to 
express its concern regarding the new Order issued by the Food Safety and Standards Authority of 
India (FSSAI) requiring imports of food products to have a certificate of Non -GM product orig in, 
which was notified in document G/TBT/N/IND/168 . It is important to highlight that, under the WTO 
Agreements, any standard of this type must be based on scientific principles.  In this case, we wish 
to stress that scientific evidence shows that genetically modified products are a s safe as their 
conventional equivalents, have been marketed safely and harmlessly for decades and have 
undergone rigorous scientific examination to prove so. In light of the above, there is no justification 
for discriminating between one or the other.  We therefore consider that the standard notified by 
India is disproportionate and creates unnecessary barriers to international trade. We have already 
submitted more detailed comments and specific questions through the TBT Focal Point and hope 
that these will  reviewed by the Indian authorities in order to safeguard the normal flow of trade in 
agri-food products.  
2.79.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and supports measures that focus on legitimate objectives, including the protection 
of human health and safety. However, New Zealand respectfully requests clarification from India 
regarding the sp ecific intent and objective of the proposed measures. New Zealand is concerned that 
India's proposed requirements regarding non -GM certification for specific foods will actually impose 
further restrictions and costs on existing trade due to the requirement  to provide consignment -based 
non-GM certification. New Zealand would appreciate clarification regarding what consideration India 
has accorded to less trade -restrictive alternatives for those countries that have not approved the 
release of any genetically modified crops into the environment. New Zealand notes the measures 
appear to be implemented under food safety legislation. If the protection of human health is the 
objective, in whole or in part, can India advise whether they intend to also notify the pro posed 
measures to the SPS Committee, given its relevance to provisions within the SPS Agreement, 
particularly Codex Alimentarius? Subsequent to India's responses, New Zealand looks forward to G/TBT/M/82  
 
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  sharing its concerns in greater detail, including by way of writ ten submission on India's notification 
G/TBT/N/IND/168 . 
2.80.   The representative of Japan  provided the following statement. Japan shares the concerns on 
India's new measure obligating a "non-GM origin and GM -free certificate " for 24 agricultural products 
imported to India. Japan has been  concerned that the India's proposed measures would create 
unnecessary trade barriers and have negative impacts on agricultural trade between India and WTO 
Members. There is a lack of clarity regarding the justification for the measure and how the measure 
will be implemented. Especially Japan would like India to explain the rationale for requiring the GM -
free certificate , for which there are no established  detection methods on GMO(s) from the GM crop , 
and how to inspect such products with the non-GM certif icate at the border in India.  Japan would 
also like India to clarify the necessity of the non -GM certificate if the production and importation of 
such GM crops are prohibited in the domestic regulations of exporting countries. Japan would like to 
ask India  to address the concerns raised by Member countries and as long as the proposed regulation 
has the substantial uncertainty and the potential negative impact on international trade, Japan would 
kindly ask India to reconsider the implementation of the propos ed measures.  
2.81.   The representative of Canada  provided the following statement. Canada recognizes India's 
sovereign right to implement measures it deems appropriate to fulfil a legitimate objective, such as 
protecting human health and safety or protecting the environment. However, Canada is concerned 
that India's non -GM import certification requirement will disproportionately impact the ability of GM -
producing countries to export to India and unnecessarily restrict international trade. Countries 
around the worl d have developed effective regulatory frameworks to assess the risks of GM food 
products prior to their approval and commercialization. In Canada, all novel products, including those 
derived from genetic modification, have undergone rigorous scientific saf ety assessments according 
to international guidance and standards, to ensure they are as safe and nutritious as their 
conventional counterpart. A novel plant product is authorized for commercialization only once it has 
received appropriate safety approvals . 
2.82.   India's new requirement will be particularly challenging for countries like Canada where the 
National Competent Authority assesses the safety of GM products prior to their release on the market 
and therefore, does not issue any import certification for t hese products. In an effort to better 
understand the health and/or safety concerns India's measures is looking to address, we respectfully 
request that India share the available scientific information and/or justification that would support 
the rationale b ehind India's non -GM certification requirement. We also strongly encourage India to 
delay the imminent implementation of this measure to provide trading partners with sufficient time 
to engage with India and have concerns taken into account. In fact, Canad a has submitted comments 
through India's TBT Enquiry Point detailing its concerns. We look forward to India's response and 
remain available to pursue further discussions on this issue in a bilateral setting.  
2.83.   The representative of Australia  provided the fol lowing statement. Australia recognizes the 
right of the Indian Government to take measures necessary to protect public health. Australia wishes 
to emphasize the importance of compliance with its WTO obligations, in particular the requirements 
that measures  be implemented in a non -discriminatory manner and in a way that is no more trade 
restrictive than necessary. This is particularly important during COVID -19 as trade facilitates food 
security around the globe. Australia is considering India's draft amendme nts to its Food and Safety 
Order related to "requirement of Non -GM cum GM -free certificate accompanied with imported food 
consignment " and intend to provide written submission within the TBT notification comment period. 
Australia welcomes India's considera tion of our comments and looks forward to India's response and 
engagement on the issue.  
2.84.   The representative of Chile provided the following statement. The Republic of Chile welcomes 
the opportunity to comment on the "Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment", communicated to the World Trade Organization by 
means of notification G/TBT/N/IND/168  and reported on 2 September 2020.  We wish to provide the 
following comment for your consideration, as regards issuing a certific ate for non -transgenic or non -
GM products:  According to the information provided, this notification will enter into force on 1 
January 2021, at which time food consignments listed in Annex 1 of the regulation referred to in this 
notification must comply wi th the issue of a certificate (Annex 2) establishing that the exported 
products are not genetically modified or transgenic.  In this regard, we wish to state that under 
Chilean law (Exempt Resolution N° 1523 of 2001), the use of genetically modified product s for 
domestic food production is not authorized. Their use is only authorized for sowing for trial purposes G/TBT/M/82  
 
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  or seed multiplication for export purposes. In this respect and to date, Chile has not authorized any 
fruit species, whether for domestic or export  use. In light of the above, it considers that requesting 
this type of certificate is establishing an unnecessary requirement.  Therefore, consignments should 
only be accompanied by the plant health certificate in the framework of the International Plant 
Protection Convention (IPPC).  Lastly, Chile thanks India for responding to such comments and for 
adopting measures aimed at strengthening international trade, and hopes to continue to collaborate 
on safe trading relations between both countries.  
2.85.   The represen tative of Paraguay  provided the following statement. We will be following the 
matter closely, as the regulation is still being analysed in our capital. We will be in contact with our 
colleagues from India, if necessary, once this analysis is complete. Like  our colleagues from other 
delegations that have spoken before us, we would welcome greater clarification on the scope of the 
measure and its scientific justification.  
2.86.   In response, the representative of India provided the following statement. In response, India 
would like to state that the Order  dated 21 August 2020 regarding the requirement of Non -GM cum 
GM-free certificate accompanied by imported food consignments was notified on 2 September 2020 
for comments from WTO TBT Member countries. The 60 -day time  to receive comments ends on 
31 October 2020. Food Safety and Standards Authority of India (FSSAI) is accepting comments on 
the said notification, which will be examined after 31 October 2020.  
2.1.2.12   Republic of Korea - Revision of Safety Conformation Criteria fo r Textile Products 
for Infants, G/TBT/N/KOR/678  (IMS ID 65215) 
2.87.   The representative of the European Union  provided the following statement. The EU would 
like to raise its concerns with regard to Korea's requirements for conformity testing of textile 
products for infants. In February 2018, Korea introduced new safety requirements for infant clothing, 
which cha nged the testing and certification procedures of these products. The EU believes that infant 
clothing has a very low human risk exposure, unlike infant humidifiers or hand warmers. Therefore, 
the EU does not have such stringent testing and certification re quirements for the safety of infant 
clothing as we believe that extra testing would be more trade restrictive than necessary to fulfil a 
legitimate objective, i.e. not in line with Article 2.2 of the TBT Agreement. It is our understanding 
that other major markets also do not have such stringent regulations on infant clothing. As a result 
of the measure, the testing and certification costs have increased substantially for European 
manufacturers. As an example, one manufacturer's average monthly costs more th an doubled in 
2018 compared to the 2017 monthly average and increased by eight times in 2019 compared to the 
2017 monthly average. Additionally, there are reports from EU industry that the testing is not been 
carried out on an equal basis between domestic and foreign producers, to the detriment of importers. 
The EU has had multiple meetings with the relevant Korean authorities in order to resolve the 
situation. The Korean Agency for Technology and Standards (KATS) has recognized that infant 
clothing is not a hazardous product, and was included in the regulation due to a separate problem 
with humidifiers. However, they are unwilling to rectify the situation despite not knowing how 
compliance has changed as a result of the measure. Compliance rates of some EU companies in 
textiles had already been more than 98.5%. Therefore, the EU would like the Korean authorities to 
take the necessary steps to remove this trade barrier.  
2.88.   In response, the representative of the Republic of Korea  provided the following statement.  
Korea appreciates the interest of EU member States in Korea's requirements for textile products for 
infants. Korea would like to deliver the official response from the regulatory authority. On 27 October 
2020, representatives of the EU in Korea and Korean  relevant authority held a meeting regarding 
this STC and discussed the concerns raised by the EU in detail. Today's answer from Korea will be 
the same as what we explained at the meeting yesterday. The EU has raised concerns regarding 
specific textile pro ducts used by or for infants less than 36 months of age, specifically, that the 
requirements are too strict given that the EU believes that infant clothing has a very low human risk 
exposure. However, a risk assessment on textile products for infants in Ko rea found that such a risk 
was high in infants, especially due to damages caused by strings, cords, harmful substances, and 
others. The safety of infant clothing products must be verified through product inspection. Korea 
also notes that the diversity and complexity of risk assessments may result in differences in the level 
of risk for infant clothing between Korea and the EU.  
 
15 For previous statements fo llow the thread under IMS ID  652 (under dates raised and references) . G/TBT/M/82  
 
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  2.89.   Regarding the EU's concerns about a substantial increase in testing and certification costs for 
European manufacturers in 2018 and 2 019 due to amended requirements for textile products for 
infants, Korea notes that period -specific EU manufacturers  had attempted to expand their sales in 
the Korean market, and the increase in the costs of testing are likely to be on a one -time basis. It 
is not likely that the increase in the costs of testing can be attributed solely to the amendment of 
the requirements. EU also claimed that testing has not been carried out on an equal basis between 
domestic and foreign producers for infant clothing. Howev er, the relevant act, the "Special Act on 
the Safety of Children's Products", certainly ensures equal treatment between domestic and foreign 
manufactures with respect to national treatment in the context of goods and manufacturers. Korea 
also notes that on  no occasion have other countries made a similar complaint in this respect. 
Furthermore, EU manufacturers stated that the compliance rate of infant clothing stands at 98.5%, 
but Korea has not found any basis for this claim. Korea very much hopes to resolve  the EU's concerns 
at this TBT Committee in a mutually beneficial manner.  
2.1.2.13   United States - Appliance Efficiency for Sprinkler Bodies, G/TBT/N/USA/1489  
(IMS ID 65316) 
2.90.   The representative of China  provided the following statement. China appreciates the efforts 
of the US to improve th e performance of sprinkler bodies. However, China still requests the US:  (i) 
to further clarify the application scope of sprinkler products;  (ii) to clarify the accuracy requirements 
of the pressure level test points in 1(c), 3(b) and 3(f) of Appendix B of  Water Sense (r) Specification 
for Spray Sprinkler Bodies. Since the requirements of test methods in ISO 15886 -3:2012 5.1 have 
been accepted and used globally, we suggest the US to be consistent with ISO standard;  (iii) to 
clarify the distance between the needle valve and the outlet pressure sensor in Appendix B, 3(c).  
2.91.   In response, the representative of the United States  provided the following statement. China 
did not submit comment to the United States through the USA WTO TBT Enquiry Point, and its 
questions came to us just this week, which is late in terms of our ability to liaise with California to 
prepare a response. We will take the concerns back with us and engage the State of California, 
accordingly. If we are able, we will post replies back to the eAgenda by 3 November or reply to China 
bilaterally after the meeting.  
2.1.2.14   Chile - Technical specifications for the design of energy efficiency labels for 
washing machines, G/TBT/N/CHL/297 , G/TBT/N/CHL/325  (IMS ID 65417) 
2.92.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to make some comments regarding this regulation as follows. Regarding the regulation on 
washing machine energy -efficiency label in Chile, Korea received official comments from the Chile 
TBT Enquiry point in July and October 2020. However, Korea has not yet received a clear response 
from Chile regarding our requests, so Korea again requests the Chilean authorities to re view the 
following concerns. According to Number 9 of Table A (Resolución Exenta N°70 de fecha 30.12.2014 
-Ministerio de Energía), the tolerance of energy consumption is ± 11% and the tolerance of water 
consumption is ± 4%. If negative tolerance is applied , it might result in failure in follow -up testing 
even though the product has better energy efficiency. Therefore, in Europe and the majority of 
countries including Korea and Peru, neighbo uring country of Chile, the tolerance of energy 
consumption and wate r consumption is less than +10 %. Thus , Korea requests Chile to modify the 
tolerance of energy consumption and water consumption on the energy efficiency label to less than 
+10%.  
2.93.   In response, the representative of Chile provided the following statement. Chile wishes to 
inform this Committee that these measures were notified in 2015, on 2 February and 2 October, 
respectively.  On both occasions, Chile allowed time for comments in this TBT Committee, pursuant 
to the provisions on transparency established by th e Agreement, and did not receive comments from 
Korea on either occasion.  The information received at this meeting will be submitted to the Ministry 
of Energy in due course in order to provide the delegation of Korea with a proper reply.  
 
16 For previous statements follow the thread under IMS ID  653 (under dates raised and references) . 
17 For previous statements follow the thread under IMS ID  654 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.2.15   European Union - Information requirements in SCIP Database (IMS ID 65518) 
2.94.   The representative of China  provided the following statement. The (EU) Directive 2018/851 
amending Directive 2008/98/EC was officially published on 14 June 2018, and came into force 20 
days later. Arti cle 9(1)(I) of (EU) 2018/851 requires that any supplier of an article shall provide 
product information as required by Article 33(1) of Registration, Evaluation, Authorization, and 
Restriction of Chemicals (REACH) (EC 1907/2006) before 5 January 2021. Arti cle 9(2) stipulates 
that European Chemicals Agency (ECHA) shall establish a database by 5 January 2020 to collect 
relevant information related to Article 33(1) of REACH. This database was defined by ECHA as the 
SCIP Database. China supports EU's management  of waste, but still remains concerned about the 
SCIP Database, and requests EU to postpone the notified deadline of 5 January 2021 to at least 12 
months after the finalization of the database. ECHA has not finalized the database for notification 
before 5 January 2020 as required by (EU) 2018/851. According to the information from ECHA, the 
final version of SCIP Database will not be available until the end of October 2020. There are only 
two months left for the suppliers to develop and test their own system s to adapt to this SCIP 
Database and prepare all information for notification. Obtaining the required information from 
international supply chains, and making validation and notification to SCIP system, are quite time 
consuming for suppliers.  
2.95.   (EU) 2018/851  stipulates that member States shall bring into force their own laws, regulations 
and administrative provisions necessary to comply with this Directive by 5 July 2020. However, to 
date, many EU member States haven't yet transposed this Directive into their  national legislation, 
which would affect the effective and consistent application of the Directive. REACH 33(1) only 
requires the suppliers to provide the recipient of the article with sufficient information to allow safe 
use of the article including, as a minimum, the name of that substance. However, the current SCIP 
Database requires more data to be notified, i.e., among others, Primary Article Identifier, Article 
category, Production in European Union, Linked Article, and Material category. It is recomm ended 
that ECHA assesses the proportionality, necessity and impact of data required other than those 
specified by REACH 33(1), and launches an industry -wide consultation process for the extra 
requirements. The notification of the articles containing SVHCs above 0.1% via SCIP Database is a 
legal obligation defined in (EU) 2018/851, the delayed submission of such information will definitely 
create compliance risks for the suppliers who provide the products on EU market. China respects 
the EU's efforts to prom ote a circular economy but hopes that EU can provide the industry with a 
sufficient transitional period to better implement these new regulations.  
2.96.   In response, the representative of the European Union  provided the following statement. The 
SCIP Database is an important step to ensure traceability of Substances of Very High Concern in 
materials and products. It will bridge the current gap in the information flow to support waste 
operators to improve their waste separation and recycling techniques and processe s. This will benefit 
both the circular economy and the objective of a toxic -free environment. As provided for in the 
revised WFD, from 5 January 2021 onwards EU suppliers have the responsibility of fulfilling the 
obligation of providing information to the ECHA on substances of very high concern in articles and 
products. EU suppliers include EU producers and assemblers, EU importers, and EU distributors of 
articles and other actors who place articles on the market. Companies outside of the EU are not 
subject  to this obligation and are not allowed to submit SCIP notifications. However, importers of 
articles in the EU need to turn to their non -EU suppliers and request information that they need to 
provide to the SCIP Database.  
2.97.   The European Union understands the  diversity and complexity of supply chains of industries, 
as well as the challenges that businesses are facing in fulfilling the obligation mandated by Article 9 
of the WFD. In this context, the European Union would like to note that certain information sh ould 
already be communicated to EU suppliers for them to fulfil their obligation under Article 33 of the 
REACH Regulation. Therefore, the Commission expects that, to a certain extent, suppliers can build 
on arrangements put in place to comply with the exis ting obligation under Article 33 of the REACH 
Regulation to provide information on the presence of substances of very high concern in articles. 
The support and collaboration of non -EU suppliers is important to ensure the achievement of the 
objectives of th e SCIP Database. The European Union encourages non -EU suppliers to support their 
EU customers by providing them the necessary information about the presence of Candidate List 
substances in their supplied articles. The Commission and ECHA have put all effor ts to ensure 
compliance with the legal obligation within the prescribed two years. Over the last 21 months, ECHA 
 
18 For previo us statements follow the thread under IMS ID  655 (under dates raised and references) . G/TBT/M/82  
 
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  has been developing the database in close consultation with the Commission services, the member 
States and the stakeholders with the objective to meet the legal deadline. ECHA has published the 
"Detailed information requirements for the SCIP Database"19 and in its SCIP format20 already in 
autumn 2019. ECHA has also provided extensive information for guidance and assistance to duty 
holders on its dedicated SCIP webpages.21 
2.98.   ECHA made the first version of the SCIP Database available in February 2020, nearly one year 
in advance of the deadline, to allow industry to get familiar with the technical functions of the 
database and test it in a "live" situation. ECHA announced that, on 28 October 2020, the SCIP 
Database will be formally opened up for submitting notifications to comply with the legal obligation, 
two months in advance of the entry into application date of the legal duty. A new manual on 
information requirements has been  published on 23 October 2020. The manual assists users in 
complying with their obligations, to identify the duty holders and the articles within the scope of the 
notification and explains the information required in a SCIP notification. The obligations of  the 
revised WFD need to be transposed into the national law of EU member States and will be enforced 
by EU member States. The Commission is monitoring the transposition of Directive 2018/851 by EU 
member States including verification of the conformity of the national transposition measures once 
notified to the Commission. The European Union remains available to provide replies with regard to 
the SCIP Database to interested Members.  
2.1.2.16   Tajikistan - Additional inspection control of imported food products for pa lm oil 
content (IMS ID 65622) 
2.99.   The representative of the Russian Federation  provided the following statement. Russia 
expresses its concern regarding Government Resolution of Tajikistan № 260 of 1 May 2020 that 
introduced a ban on imports of palm oil and ins tructs Tajikistan's authorities to conduct laboratory 
inspection control of imported food products to identify if they contain palm oil as an ingredient. We 
recognize Tajikistan's right to protect public health. However, this protection shall be in line wi th 
Tajikistan's international obligations, specifically, WTO provisions. In this regard we would like to 
highlight the following points. Firstly, the Resolution in question introduced mandatory laboratory 
inspections. Such requirements represent conformity  assessment procedures and should be notified 
to the WTO under Article 5.6 of the TBT Agreement to allow interested Members to submit 
comments. Secondly, Tajikistan should have provided the transition period for adaptation to new 
requirements of not less t han six months after publication of new requirements. Unfortunately, 
neither notification nor reasonable period of time to adapt have been provided by Tajikistan. Thirdly, 
the Resolution does not contain similar requirements for domestic manufacturers. In this regard, 
Tajikistan seems to act not in compliance with national treatment obligation of Article 2.1 of the TBT 
Agreement. Fourthly, the Resolution does not specify schemes and procedures for laboratory 
inspection control upon importation which creates  uncertainties for exporters for all kinds of food 
products containing edible oil. Russia requests to suspend the Resolution, notify it under the TBT 
Agreement, consider the comments of the WTO Members and take them into account. We urge 
Tajikistan to elim inate all discriminatory provisions of the Resolution and bring it in conformity with 
WTO rules. Russia remains open for bilateral engagement with Tajikistan on this and other issues.  
2.100.   In response, the representative of Tajikistan  provided the following sta tement. I would like 
to thank the Russian Federation for their interest and exchange of views well ahead of this meeting.  
While the issue is being reviewed by the capital I want to share the following updates. According to 
Item 1 of the Resolution № 260 da ted 1 May 2020  the import of all types of palm oil, with the 
exception of its import as a raw material for industrial processing and production of final products 
are prohibited into  the territory of the Republic of Tajikistan.  Accordingly based on Paragrap h 2 Item 
3 of the Resolution  the Committee  for Food Security  was instructed, together with the ministries of 
industry and new technologies, health and social protection of population, the Agency for 
Standardization, Metrology, Certification and Trade Inspe ction within two months  bring normative 
and technical documentation on food products, in the production of which the use of palm oil is 
envisaged  in compliance with the requirements of this regulation.  Based on scientific evidences palm 
 
19 
https://echa.europa.eu/documents/10162/28213971/scip_information_requirements_en.pdf/9715c4b1 -d5fb-
b2de-bfb0-c216ee6a785d   
20 https://echa.europa.eu/scip -format   
21 https://echa.europa.eu/scip -database   
22 For previous statements follow the thread under IMS ID  656 (under dates raised and references) . G/TBT/M/82  
 
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  oil is a harmful pr oduct, the consumption of which increases the level of cholesterol in the human 
body, causes heart disease, stroke, gastrointestinal tract, diabetes and obesity, as well as adversely 
affects human genetics, leading to cancer and infertility.  
2.101.   According to t he norms set by the World Health Organization, the daily intake of non -dietary 
fats, including palm oil, should not exceed 1 %. Currently palm oil is widely used in the production 
of baby food, confectionery and dairy products.  In particular, there are case s of adding palm oil to 
the composition of ice cream, sour cream, cream, butter, confectionery and other foodst uff in the 
food industry of the country . Unfortunately, most foreign and domestic manufacturers do not provide 
the necessary information on the u se or existence  of palm oil in the packaging or label of the product, 
which contradicts the relevant provisions of the TBT Agreement. Please note that the Resolution is 
in compliance with WTO rules particularly with Article XX of GATT (General Exceptions) sub-
paragraph (b) necessary to protect human, animal or plant life or health.  According to available 
information at present due to harmful effects of palm oil on human health, its import and use is 
restricted in some countries, and the legislation of some countries including the Russian Federation 
impose s additional customs duties on its import.  Finally, my delegation stands ready to discuss the 
issue bilaterally.  
2.1.2.17   France - New legislative requirements about index of repairability of electrical 
and electroni c equipment (IMS ID 65723) 
2.102.   The representative of China  provided the following statement. China supports France's 
efforts to fight against waste and boost the circular economy and looks forward to the consideration 
of replies to our concerns. With the wide scope of electronic and electrical equipment, the mandatory 
requirements may have a significant impact on the design, production and sales of electronic and 
electrical equipment for manufacturers. China requests France to notify the contents relating to 
article L541 -9-2 of France Environmental Code as well as a draft decree in the Council of France 
relating to the method of calculation and the information signage for consumers of the obligatory 
reparability index for electrical and electronic products sold in France, so that other WTO Members 
can comment. It is recommended that France provides a reasonable transition period for the 
implementation of article L541 -9-2 of the France Environmental Code. Article L541 -9-2 of the France 
Environmental Code will take  effect on 1 January 2021. However, key elements such as the products 
that are subject to the new requirements, the testing methods and standards, and the conformity 
assessment methods necessary for the implementation of the new requirements are not releas ed. 
The COVID -19 epidemic also added difficulties for the enterprises to adapt to the new requirements. 
According to Article 2.12 of the TBT Agreement, China requests France to postpone the application 
of this requirement to at least one year after the pub lication of the list of relevant equipment, the 
standards, calculation methods and compliance methods of the index of reparability, or provide 
different transition periods according to the complexity of the structure of electrical and electronic 
equipment.  
2.103.   In response, the representative of the European Union  provided the following statement. 
France has notified this draft decree to the WTO, as well as the related draft orders, on 23 October 
2020, the day after the above -mentioned draft texts had completed their intra -EU assessment. 
These notifications  are currently being processed by the WTO Secretariat . French Law n ° 2020 -105 
of 10 February 2020 relating to the fight against waste and the circular economy provides in Article 
130 for the entry into force o n 1 January 2021 of the provisions provided for in Article 16 relating to 
the implementation of a reparability index on electrical and electronic equipment. However, the 
checks and penalties for failure to make the reparability index available to consumers  or for incorrect 
calculations will only be applicable from 1 January 2022, in accordance with the provisions of the 
same article 130 of the law. This provision reflects the consideration of the need for economic actors 
for an adaptation period for the dep loyment of the measure in the first year of implementation.  
2.1.2.18   European Union - Waste Framework Directive (IMS ID 65824) 
2.104.   The representative of India provided the following statement. The Republic of India 
understands and supports the EU's efforts on waste man agement but is strongly concerned about 
EU's Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 
(Amendment to 2008 WFD) which adversely affects the Indian exporters to the EU. India would 
 
23 For previous statements follow the thread under IMS ID  657 (under dates raised and references) . 
24 For previous statements follo w the thread under IMS ID  658 (under dates raised and references) . G/TBT/M/82  
 
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  appreciate if the EU could respond  to this concern in writing. The Scheme : The revised EU WFD 
obliges suppliers to provide, starting from 5 January 2021, details of articles placed in the EU, to 
ECHA. This Directive seeks information on substances of very high concern from the Candidate Li st 
that is maintained with REACH which are present in the supplied articles. Furthermore, while this 
information can be supplied directly by the manufacturers based in Europe, the same is not possible 
for the manufacturers from outside of the EU, who have to engage an intermediary (i.e. Only 
Representative) to provide the information.  
2.105.   Negative impact : This measure bears the following effects on the exporters of articles to the 
EU. It increases the administrative burden on the business operators and the industry. It imposes 
additional costs. Its negative impact on the Micro, Small and Medium -sized Enterp rises (MSMEs) will 
be detrimental. For non -EU Members, it increases additional barriers. As per the Directive, the 
responsibility for fulfilling the requirements of ECHA in line with REACH lies with the importers 
established in the European Union. Since ma nufacturers or exporters cannot directly provide the 
information to ECHA, they will be forced to contract a representative established in the European 
Union to undertake the required registration process. This requirement is applicable to all 
manufacturers , exporters, and distributors, regardless of the quantity of article placed in the EU. 
This will add to the increase in costs and also act as a barrier to trade for non -EU countries, 
particularly because: suppliers who place less than 1 -tonne quantity of t he article annually are also 
required to engage a representative, which they were previously not required to do if the article 
contained SVHCs; distributors, etc., also have to comply with this obligation, which creates duplicity 
of notification requiremen ts, since the manufacturer may already have provided the relevant 
information to the ECHA.  
2.106.   WTO Agreement Violation : Under the Transparency and Notification obligations of the TBT 
Agreement, Members are required to notify all new measures. It is observed th at no notification has 
been made by the EU or the EU member States to the WTO before they transpose and implement 
this legislation. Action Sought from EU : Given the above, India would like to request the EU to: 
notify this measure to WTO; and defer implementation of this measure until the comments are 
received from the Members.  
2.107.   The representative of the United States  provided the following statement. We appreciate the 
opportunity to raise this new concern regarding Directive (EU) 2018/851 of the Euro pean Union and 
of the Council of 30 May 2018 amending Directive 2008/98/EC on waste. Specifically, we are hearing 
concerns from industry regarding the information reporting requirements associated with the new 
Substances of Concern In articles as such or i n complex Products (SCIP) Database (SCIP) chemicals 
database being created by ECHA. We appreciate that ECHA has been working with industry over the 
last two years on the development of the database, including holding several stakeholder workshops. 
However,  there are several remaining concerns. We are aware that there have been several delays 
in the roll out of the database and now there will be a very short timeframe between when the 
database is expected to be finalized in October and when companies have to  fully comply with the 
reporting requirements in January 2021. We also understand that the reporting requirements for 
substances of very high concern (SVHC) have been greatly increased, expanding the number of 
mandatory elements from two to seven and inclu ding additional information elements. Furthermore, 
we are hearing concerns from industry about the protection of their intellectual property as the 
database will be public. We understand that these concerns are shared by European, Asian, and 
North and Sout h American industries and that industry has asked for a one -year delay to work out 
the remaining implementation issues with the database and to provide time for companies to obtain 
the information from their suppliers. How do you intend to address these co ncerns? Are you 
considering a delay? In your view, is just over two months really enough time for industry to be able 
to get up to speed on a new system for reporting on additional elements for what is sometimes 
thousands of product components? What happen s if member States have not transposed the 
requirements into their legislation by January 2021?  
2.108.   The representative of Canada  provided the following statement. Under Article 9.2 of the 
WFD, the ECHA was under the legal obligation to establish the SCIP Datab ase by 5 January 2020. 
However, despite a recently announced date for the formal launch of the database of 28 October 
2020 – which is today - the legal obligation for importers and suppliers to input data into the 
database remains unchanged, and legal enfo rcement will apply from 5 January 2021, which is only 
two months away. Operators have lost the expected transition period built in the Directive to assess, 
prepare, and input the information in the SCIP Database. This has caused significant concern among 
Canadian industry stakeholders, who, despite their best efforts at preparing for this change, now G/TBT/M/82  
 
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  fear they may lack the time required to have their data recorded in the database. Complex products 
will require numerous notifications, whose parameters, detai ls and format have only been confirmed 
and finalized by ECHA in past weeks. The EU borders will be a clear checkpoint for enforcement of 
the Directive  on foreign goods entering the EU, and Canada is concerned that the various degree of 
independence in memb er States' enforcement mechanisms will affect the homogenous application 
and enforcement of the database across the EU as of 5 January 2020. In light of this, Canada 
respectfully requests that the EU delay the entry into effect of the SCIP Database for at least one 
year to give operators and member States the time to further comply with the requirements.  
2.109.   In response, the representative of the European Union provided the following statement. 
The EU refers to its statement under item 2.1.2.15   .25 I am aware that this measure causes concern 
among importers to the EU, so the EU is open to bilateral contact provided they are available to 
reply bilaterally to Members. I suspec t that this point will stay in the Committee for a while so I 
would ask Members to put everything in one point. I simply note that this is the same issue as STC 
17. 
2.1.2.19   European Union - Wine labelling requirements – listing of importers for multiple 
destinatio ns (IMS ID 65926) 
2.110.   The representative of Australia  provided the following statement. Australia understands that, 
following the end of the Brexit transition period, the UK intends to roll over existing EU wine laws 
and regulations. As the EU would be aware, this will mean that from 1 January 2021, wine imported 
into in the UK, either in bulk or in bottles, and sold in the UK will require the name and address of a 
UK-based importer on the label. We understand that this will be the same as the requirement that 
currently applies, and will continue to apply to bottled wine sold in the EU market. Given that wine 
is regularly exported to the EU through the UK, it would be logical for wine to give details of both 
EU and UK importers on a single label; and ensure trad e can continue uninterrupted and without 
additional expense to wine producers. Under EU regulation, we understand that an indication of the 
"importer" is a compulsory indication for wine imported into the EU (under Regulation No. 1308/2013 
and Delegated Re gulation 2019/33) to identify the natural or legal person or group of persons 
importing the wine into the EU. We are supportive of the EU's objective of clearly identifying the 
business food operator, i.e. the person assuming responsibility for bringing th e wine into circulation 
in the EU, and not misleading consumers.  
2.111.   However, we are requesting that the EU ensure its labelling requirements are no more trade 
restrictive than necessary to achieve the EU's objectives. We believe that the EU allowing an 
"optio nal particular" on labels to cover importers in other third countries would be consistent with 
the EU's objectives, while still clearly identifying the EU importer and person assuming responsibility, 
for example: "For the EU, imported by:" and "For the UK,  imported by:". Australia is seeking clarity 
from the EU whether under current EU regulation it is possible to list importers for multiple 
destinations on the same wine bottle label. Further guidance and clarity are important to provide 
certainty to trader s and ensure no interruptions to trade occur at the end of the Brexit transition 
period. We look forward to working closely with the EU on this issue in coming weeks to ensure a 
mutually satisfactory outcome by the end of the Brexit transition period and w e are continuing similar 
discussions with the UK to resolve this issue for wine imported into the UK.  
2.112.   In response, the representative of the European Union  provided the following statement. 
The EU points out that the indication of the "importer" is a compu lsory indication for wine imported 
into the EU and that the importer is a natural or legal person or a group of such persons established 
in the EU. Any other indication on the label mentioning the entity that brought the wine into another 
third country bef ore import into the Union could be only acceptable as an optional particular, 
provided it does not appear in combination with the words "importer" or "imported by (…)" and is 
not misleading for consumers as regards the business food operator (i.e. the pers on assuming 
responsibility for bringing the wine into circulation in the EU).  
 
25 European Union - Information requirements in SCIP Database (IMS ID 655).  
26 For previous statements follow the thread under IMS ID  659 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.2.20   India - Phthalic Anhydride (Quality Control) Order, 2019, G/TBT/N/IND/116  
(IMS ID 66027) 
2.113.   The representative of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following sta tement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to express our concerns over the Order of India's Ministry of Chemicals and 
Fertilizers on Phthalic Anhydride, published on 23 April 2020. The draft measure was notified by 
India to the TBT Committee as G/TBT/N/IND/116  on 25 November 2019. The Order came into force 
on 23 October 2020. Given this Order is part of a series of 22 orders on chemicals notified by India 
since 2019, our concerns expressed in item 2.1.3.10   28 will also apply to this measure except that 
we would like to focus on three points of concerns here. Firstly, the annual factory visit requirement 
remains as our major concern over the Order. Impl ementation of such requirement creates 
additional costs and extra burden for manufacturers located outside India. The COVID -19 pandemic 
makes the situation even worse for foreign manufacturers because the access of their products to 
Indian market is tantam ount to a factual denial when arrangement for a factory inspection visit is 
not possible due to the restrictions of cross -country travel. Moreover, it is hard to be optimistic that 
the travel restrictions will be lifted at any time soon as the confirmed ca ses are still rising. This 
makes it more difficult, if not impossible, for foreign manufacturers to comply with the said 
requirement even if they are willing to do so. We thank India for giving another 90 days to postpone 
the effective date of this measure  to 17 January 2021, which however in our view is still difficult for 
our manufacturers to complete the required procedures. To this end, we take this opportunity to 
recommend that the Indian Government consider a suspension of or a temporary exemption fro m 
the on -site factory visit requirements for foreign manufacturers during the period of COVID -19 
pandemic.  
2.114.   If India still considers on -site visit necessary, we suggest that the Indian authorities consider 
alternative measures temporarily adopted in respons e to the severe circumstance of pandemic, such 
as authorizing or commissioning qualified inspection bodies located in the exporting Members (e.g. 
inspection bodies accredited under the ILAC -MRA framework) to perform on -site factory visits on its 
behalf at least during the COVID -19 pandemic to mitigate the severe difficulties faced by foreign 
manufacturers. In this case, the Indian inspection agency can still participate remotely through video 
conference and/or supplementary document reviews. Similar approac hes, i.e. alternative procedures 
to enable compliance to be checked by remote or electronic means, have also been adopted by some 
WTO Members as indicated in the document "Standards, Regulations and COVID -19 – What Actions 
Taken by WTO Members? " prepared b y the WTO Secretariat. We would like to urge India to take 
these alternative procedures into consideration so that the impact of COVID -19 on trade in goods 
can be reduced. My government adopted temporary measures to assist foreign manufacturers in 
meeting the requirements for factory visit/inspection in response to the impact of COVID -19 
pandemic. The inspection is performed remotely, following the practices stated in IAF MD4:2018 
"IAF Mandatory Document for the Use of ICT for Auditing/Assessment Purposes " and supported by 
document review. An on -site visit/inspection shall be arranged within six months after the travel 
restriction is lifted. If India is interested in detailed practices of our approach, we will be pleased to 
share our experiences. We would be  grateful if India would take the above -mentioned comments 
into account and reflect in the implementation of the Order accordingly.  
2.115.   In response, the representative of India provided the following statement. We thank the 
Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu for their interest in the matter. 
The concern raised is noted, and the matter is under examination.  
2.1.2.21   Viet Nam - Decree No.17/2020/ND -CP, G/TBT/N/VNM/116/Add.2  (IMS ID 
66129) 
2.116.   The representative of Thailand  provided the following statement. Thailand would like to 
thank Viet Nam for amending Decree 116/2017/ND -CP which has been promulgated in Decree 
No.17/2020/ND -CP. We are glad to learn that Viet Nam took Thailand' s requests and accepted ISO 
9001 certificate and IATF 16949 certificate, prescribed in document no. 8753/BGTVT -KHCN dated 
4 September 2020, as documents to ensure conformity of production. However, there are some 
remaining difficulties which our manufactur ers and exporters have faced, as a result of Decree 
 
27 For previous statements follow the thread under IMS ID  660 (under dates raised and references) . 
28 India - Quality Control Orders for Chemical and Petrochemical Substances (IMS ID 630).  
29 For previous statements follow the thread under IMS ID  661 (under dates raised and references) . G/TBT/M/82  
 
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  17/2020/ND -CP implementation and some required practices, regarding emission test for type 
assessment and additional documents required by Viet Nam authorities during COVID -19 epidemic. 
First, Viet Nam ma ndates every model in each type of vehicles is subject to  the emission test  for 
type assessment which is not in compliance with international practices. We would like to remind 
Viet Nam that the  TBT Agreement requires that technical regulations  shall be no t more trade 
restrictive than necessary to fulfil a legitimate objective and not create unnecessary obstacles to 
international trade. Therefore, we request Viet Nam to test only one vehicle that is the representative 
of the type with the highest emission l evel to ensure all other models in that type will meet the 
emission requirement.  
2.117.   Secondly, during the COVID -19 pandemic, Viet Nam authority allows importers to submit 
COP certificate, ECE certificate or UNECE  certificate, instead of testing facility. We fo und that Viet 
Nam requires Thai importers to submit additional document after submitting COP certificate, ECE 
certificate such as list of equipment and instrument used in production process including detailed 
information of its numbers and manufacturing da tes. We consider that the additional document 
requirement may cause difficulties and create unnecessary obstacles to trade between Thailand and 
Viet Nam. In this regard, we would like to request Viet Nam if Viet Nam could possibly waive the 
mentioned addit ional document in order to facilitate trade between us. Lastly, we  would be grateful 
if Viet Nam takes our concerns into consideration and amends the above -mentioned issues which 
are also found in our written comments.  
2.118.   The representative of Japan  provided  the following statement. Japan would like to share 
concerns regarding Decree No.17/2020 expressed by Thailand. We welcome the amendment of the 
Degree 116/2018 by the Decree 17/2020. Japan would like to request that Viet Nam ensure that 
the operation of th ese revised regulations will not be more trade restrictive than necessary.  
2.119.   In response, the representative of Viet Nam  provided the following statement. Viet Nam 
would like to thank Thailand and Japan for conveying your concerns on the implementation of De cree 
17/2020/ND -CP of Viet Nam. Decree 17/2020/ND -CP was notified to WTO Members on 28 April 2020 
in notification G/TBT/N/VNM/116/Add.2 , which clearly indicated that the amended and 
supplemented provisions of Decree 116/2018/ND -CP came into force on 5 February 2020. Dec ree 
No. 17/2020/ND -CP also requires COP assessment at the relevant foreign facility to ensure the 
conformity of production in a non -discriminatory manner. However, on -site COP assessment of a 
foreign facility is impossible in the COVID -19 pandemic. To avoi d disruption of trade, Viet Nam has 
temporarily postponed the requirement and just accepted ECE, EC, or IATF16949 certificate as 
evidence of conformity of production. The on -site COP assessment will be resumed onward and 
retroactively when a respective exp orting country declares free from COVID -19. For the purpose of 
the on -site assessment, an "Information Sheet" is provided for manufacturers to fill in the necessary 
information. Please note that this form is applicable to both domestic and foreign manufact urers. 
Since on -site assessment of a foreign facility cannot be made during this COVID -19 pandemic, the 
importers are only asked to provide general information about the manufacturer and its products. 
The remainder of the form will need to be filled in aft er the on -site COP assessments are performed. 
Having explained that, we would like to emphasize that Viet Nam is open, flexible to facilitate trade 
and address any concerns. We are ready to provide additional information or explanation to Thailand 
and Japa n if they so wish through bilateral consultations.  
2.1.2.22   Panama - Onions and Potatoes Harvest Life and Sprouting Requirements, 
G/TBT/N/PAN/86 , G/TBT/N/PAN/102 , G/TBT/N/PAN/102/Add.1  (IMS ID 66230) 
2.120.   The representative of the United States  provided the following statement. In 2016 and 2019, 
Panama notified its onion and potato regu lations, respectively, to the TBT Committee, establishing 
a harvest date requirement, a sprouting limit, and temperature and storage criteria. We commented 
on both measures, and the US Embassy in Panama discussed our concerns with Panamanian officials 
many  times. Our concerns were not addressed. We thank Panama for delaying implementation of 
the potato regulation until 2 January 2021. We request that Panama postpone the harvest date and 
sprouting requirements from both regulations and notify the TBT Committ ee of these regulatory 
changes. The harvest date requirement and sprouting limit for potatoes and onions are unnecessary 
and are not commercially viable. Panama has not provided scientific justification for these 
requirements. For both products, the retail er and the consumer visually inspect the product before 
 
30 For previous statements follow the thread under IMS ID  662 (under dates r aised and references) . G/TBT/M/82  
 
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  purchasing. Quality defects such as sprouting and rot are easy to see, and the consumer has the 
choice of whether to buy the product.  
2.121.   Panama has provided no scientific assessment of the adverse health  effects from consuming 
sprouts – most consumers simply cut them off or choose not to buy them. To be clear, we are not 
asking Panama to remove the restriction on rotten vegetables. The United States is not aware of 
any shipments of rotten vegetables to Pa nama. Panama's measures also deviate from the relevant 
international standard in the Codex Alimentarius. The relevant Codex standard specifically excludes 
fruits and vegetables from "best by " labelling. What is the justification for Panama's deviation from  
this standard? US onion exports have already been negatively impacted. In February, Panama 
detained a number of shipments and destroyed US onions for non -compliance with the harvest date 
requirement. US onion exports to Panama have dropped 72% compared to  last year. US potato 
shipments will also be unable to comply with the harvest date requirement. We also ask Panama to 
clarify the purpose of the temperature and storage requirements. If they are for SPS -related reasons, 
Panama should suspend this part of the regulations until it has notified them to the SPS Committee 
and considered comments submitted.  
2.122.   In response, the representative of Panama  provided the following statement. We have 
maintained contact with both the delegation of the United States and our capital so as to address 
this concern . We will continue such efforts. In the meantime, we take note of the comments made 
today, which I will  forward to my Ministry . We hope that we will soon have some information to 
share with this Committee . 
2.1.2.23   United Kingdom - Wine labelling and documentation requirements at the end of 
the Brexit transition period (IMS ID 66331) 
2.123.   The representative of Australia  provided the following statement. Australia would like to seek 
clarification on the labelling and paperwork requirements that will apply to wine imports into the 
United Kingdom after the Brexit transition period. Our wine in dustry is concerned with the current 
lack of clarity around the requirements despite the Brexit transition period scheduled to finish at the 
end of year. Australia understands that, following the UK's exit from the European Union, the UK 
intends to roll ov er existing EU wine laws and regulations. However, it is still not clear what labelling 
requirements will apply to agri -food products exported from the UK to the EU, including, for example: 
Australian bulk wine bottled in, and then re -exported from the UK;  as well as bottled wine exported 
to the UK, some of which may be transhipped to other markets. We are interested in ensuring there 
is the flexibility to allow the listing of importers for multiple destinations on the label on wine bottles 
imported into th e UK. We believe it is possible to include a UK importer, as well as importers in other 
third countries and still meet regulatory objectives post -Brexit transition period, for example: "For 
the UK, imported by:" and "For the EU, imported by:". Our industry  is also concerned with the lack 
of clarity on the documentation requirements for imported wine following the Brexit transition period. 
It isn't clear whether a VI -1 form, or its equivalent, will be required to import into the UK, and then 
whether a separa te, additional, VI -1 form will then be needed to export from the UK to the EU; and 
whether similarly an additional VI -1 form is needed if wine is exported to the EU and then exported 
to the UK. Australia recognizes the United Kingdom's right to regulate, b ut we would like to seek the 
UK's assurance that the certification paperwork and labelling requirements required for the UK 
market will not be overly burdensome and create undue delay and costs. We want the UK to ensure 
any labelling and paperwork requirem ents are no more trade restrictive than necessary to achieve 
their objectives and look forward to working closely with the UK on this issue to ensure a mutually 
satisfactory outcome by the end of the Brexit transition period.  
2.124.   The representative of Uruguay  provided the following statement. Our delegation has 
indicated to our peers in the United Kingdom, in various forums, its interest in understanding the 
regulatory requirements and conditions that will apply to various agricultural  exports from Uruguay 
once the transition period established in the Agreement on the  United Kingdom's withdrawal from 
the European Union has expired . In that regard, since the United Kingdom has been the main 
destination for Uruguayan wine exports  to the European Common Market in r ecent years, our 
delegation wishes to express its interest in receiving detailed information on the regulatory 
requirements and conditions, including  for documentation and labelling, that will apply to wine 
imports to this Member's market as of 1 January 2 021. 
 
31 For previous statements follow the thread under IMS ID  663 (under dates raised and references) . G/TBT/M/82  
 
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  2.125.   In response, the representative of the United Kingdom  provided the following statement. 
The United Kingdom would like to thank Australia and Uruguay for their interest in our wine labelling 
and documentation requirements following the end of the Unite d Kingdom -European Union transition 
period. We would also like to thank Australia for the constructive engagement we have had on this 
topic bilaterally. We look forward to reviewing Uruguay's comments in due course. As detailed in the 
United Kingdom's stat ement of the 26 February 2020 under Article 15.2 of the TBT Agreement, 
(contained in document G/TBT/2/Add.128 , the United Kingdom ceased to be a member State of the 
European Union on 31 January 2020. The United Kingdom and the European Union agreed to a 
transition period, due to en d on 31 December 2020, during which the large majority of European 
Union law continues to apply in the United Kingdom. The European Union Withdrawal Act 2018 
preserves and incorporates into our domestic law, those elements of European Union law which will 
apply in the United Kingdom at the end of that transition period. The United Kingdom Government 
announced on 14 October 2020 measures setting out requirements for importer details and wine 
product labels for products to be marketed up until 1 October 2022.  Until that date, wine marketed 
in Great Britain can show either a United Kingdom or a European Union importer on the label. If 
there are later changes after that date, we will notify interested parties. From the 1 January 2021, 
the United Kingdom will con tinue to accept European Union wine import certificates (VI -1). These 
arrangements are set out in the Common Organization of the Markets in Agricultural Products and 
Common Agricultural Policy (Miscellaneous Amendments) (EU Exit) Regulations 2019.  
2.126.   Provisio ns relating to the operation of United Kingdom VI -1 arrangements, including the pro -
forma of the United Kingdom VI -1 form, are contained in the Agricultural Products, Food and Drink 
(Amendment etc.) (EU Exit) Regulations 2020 and The Food and Drink, Veteri nary Medicines and 
Residues (Amendment etc.) (EU Exit) Regulations 2019 as read in parallel with the appropriate 
retained European Union law. Further details of the labelling and certification measures being 
introduced will soon be available on the UK Gove rnment website.32 Arrangements  relating to imports, 
exports and movement of wine will all be subject to simplified procedures as set out in the United 
Kingdom/Australia Agreement on Trade in Wine upon its entry into force. From the 1 January 2021, 
wine bot tled in the United Kingdom and re -exported to the European Union will continue to be subject 
to European Union rules. The United Kingdom takes note that Australia has sought assurances that 
our processes will not be overly burdensome. We will work closely with the industry to ensure a 
streamlined system is developed, ensuring that any labelling and documentation requirements are 
no more trade restrictive than necessary to achieve our policy objectives. The United Kingdom 
welcomes further bilateral engagemen t with Australia and Uruguay if additional clarification is 
necessary.  
2.1.2.24   United States - Revised Origin Marking Requirement for Goods Produced in Hong 
Kong (IMS ID 66433) 
2.127.   The representative of Hong Kong, China  provided the following statement. Hong Kong, Chi na 
would like to express its strong objection to the revised requirement promulgated by the United 
States Customs and Border Protection (USCBP) that affects goods produced in Hong Kong and 
imported into the US. On 11 August 2020, the USCBP published a noti ce that, after 25 September 
2020, goods produced in Hong Kong must be marked to indicate that their origin is "China " for the 
purposes of the origin marking requirement set forth in Section 304 of the Tariff Act of 1930, 19 
U.S.C. § 1304. By a subsequent n otice, the USCBP extended the date for compliance with this 
requirement to 9 November 2020. The US' measure arbitrarily dictates the name to be used on the 
origin marking without regard to the facts, prevailing commercial practices and relevant WTO rules. 
It in effect deprives the rights of Hong Kong products being marked "Hong Kong " in their origin 
markings. The US' measure constitutes a "technical regulation " under the TBT Agreement and such 
technical regulation is inconsistent with the TBT Agreement as t he US does not accord to products 
imported from Hong Kong treatment no less favourable than the treatment that it accords to like 
products originating in other countries. In mid -September, Hong Kong, China wrote to request the 
US to withdraw such measure w ith immediate effect and sought bilateral discussions with the US 
with a view to resolving the matter in our mutual interests. We also took the opportunity at the 
General Council meeting on 13 October and the Committee on Trade Facilitation meeting on 20 
October to register our concerns. Regrettably, the US has so far not withdrawn the measure. As a 
result, earlier today, Hong Kong, China filed a request for consultations with the US in accordance 
with the rules and procedures of the WTO dispute settlement mechanism and relevant provisions in 
 
32 https://www.gov.uk/  
33 For previous statements follow the thread under IMS ID  664 (under dates raised and references) . G/TBT/M/82  
 
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  the WTO agreements. We urge, again, the US to honour its commitment under the TBT Agreement, 
take necessary actions to ensure its compliance with the Agreement as well as other rules under the 
WTO, and withdraw immediat ely its revised origin marking requirement on Hong Kong products.  
2.128.   In response, the representative of the United States  provided the following statement. The 
United States has no comment.  
2.1.3   Previously raised concerns  
2.1.3.1   China - Requirements for information secur ity products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (IMS ID 29434) 
2.129.   The representati ve of Japan  provided the following statement. Japan continues to have 
concerns regarding 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 
which we made at the last TBT Committee in May 2020. With respect to "Regulation on the 
Administration of Commercial Cipher Codes ", we recognize that the public consultation was 
completed on 19 Septembe r 2020. Since Japan provided comments primarily concerning the 
following points, Japan would like to request that China consider these points and reflect them in 
the regulation. Japan requests China to clarify the definitions of terms, the concrete require ment for 
review, and the scope of the regulation. Japan asks China to make certain that foreign companies' 
market access to China will not be hampered and that confidential technology will not be leaked. 
Japan requests China to ensure that the development of relevant regulations and procedures be 
consistent with international standards and practices. Japan would like to request that China provide 
relevant information regarding the current revision process and that the regulations would be 
implemented transp arently.  
2.130.   The representative of the European Union  provided the following statement. Regarding the 
MLPS, the EU would like to refer to its comments and points raised in its statement at previous TBT 
Committee meetings, namely concerns around (i) the further  extension in scope of protection Level 
3 and above; (ii) the nature of the expert review that the guidelines prescribe; and (iii) a lack of 
clarity in certain definitions, and subsequent unwarranted and significant market entry restrictions. 
The EU calls for enhanced proportionality and transparency in the implementation of the Cyber -
MLPS, instead of introducing burdensome requirements and broadening the scope of Level 3 
networks. The EU also asks China to confirm whether the draft will be notified to the WTO for 
comments, to allow for adequate participation of interested parties.  
2.131.   In response, the representative of China  provided the following statement. Regarding the 
Multi-Level Protection Scheme (MLPS ), as technology develops, in response to more complica ted 
cybersecurity circumstances, information security MLPS needs to be improved. Based on experience 
in past years and responding to new development, Cybersecurity Law stipulates that China will carry 
out the cybersecurity MLPS, which is based on informati on security MLPS. To fulfil the requirements 
in Cybersecurity Law, regulations on cybersecurity MLPS is under drafting, which was published for 
comments in June 2018 and will replace the former administrative measures on information security 
MLPS.  
2.1.3.2   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1313  (IMS ID 42835) 
2.132.   The representative of the Republic of Korea  provided the following statement. Korea thanks 
China for engaging in -depth discussions and provi ding replies on the recognition of internationally 
accredited laboratories through bilateral and the multilateral channels including the WTO Committee 
meeting. We note China's reply that "qualified laboratories " under the draft revision of the regulation 
means testing organizations certified by the NMPA. However, we regret that China has not taken the 
opportunity to respond to our question on whether internationally accredited laboratories would also 
be recognized as NMPA -certified laboratories in China. Wi thout China's reply to this question, Korea 
is led to believe that China will not recognize internationally accredited laboratories. Thus, Korea 
 
34 For previous statements follow the thread under IMS ID  294 (under dates raised and references) . 
35 For previous statements follow the thread under IMS ID  428 (under dates raised and references) . G/TBT/M/82  
 
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  urges China to respond specifically and clearly on whether the NMPA will recognize test results from 
internatio nally accredited or overseas laboratories. Korea also requests China to share related 
procedures if it plans to recognize the results from the overseas laboratories. If not, we invite China 
to consider recognizing results from internationally accredited or  overseas laboratories through 
NMPA certification. This would reduce time and costs needed for the industry to prepare for the 
registration or authorization in China and help to facilitate trade. Lastly, we kindly ask China to share 
the information on the date of entry into force of the revised regulations currently under review by 
the judiciary branch once the timeline becomes finalized.  
2.133.   In response, the representative of China  provided the following statement. At present, the 
competent authority is revisi ng the "Regulations on the Supervision and Administration of Medical 
Devices" and will promptly announce to the public when the procedures are over.  
2.1.3.3   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Ne twork Products and Services (IMS ID 53336) 
2.134.   The representative of Japan  provided the following statement. Japan has concerns regarding 
the Cybersecurity Review Measures and would like to refer to the previous statement which we made 
at the last TBT Committe e in May 2020. At the last TBT Committee, China explained that the 
Cybersecurity Review of Network Products and Services is not to restrict nor discriminate against 
foreign products and services, and China welcomes foreign products and services to enter th e 
Chinese market. Japan would like to request that China provide relevant information regarding the 
current revision process and that the regulations be implemented transparently.  
2.135.   The representative of the European Union  provided the following statement. T he EU has 
raised the Security Review of Network 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 to the publ ic consultation. We understand that these 
Review Measures entered into force 1 June 2020. 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 conc erns for foreign ICT operators. The measures are directed towards the 
purchasing activity of Critical Information Infrastructure (CII) operators by encouraging operators 
to apply for reviews in the case that they deem their purchase or procurement might po se a risk to 
the Chinese national security. Most European companies established in China would become 
suppliers or sub -suppliers of these operators, and therefore would also be affected by the reviews. 
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. For its specific comments, the EU 
refers to its statement at previous TBT Committee meetings and we would appreciate clarifications 
to our previously  raised questions. Can China also please provide an update of this measure?  
2.136.   The representative of Canada  provided the following statement. Canada would like to echo 
the points made by the European Union and Japan. Canada remains concerned by the absence of 
the following in the Implementing Measures for the Cybersecurity Review, which we understand 
were broug ht into force on 1 June without revision: clarity regarding what constitutes CII; defined 
criteria operators of CII are to use in assessing a security threat; and a clear commitment to national 
treatment, MFN treatment and the use of international standard s. 
2.137.   In response, the representative of China  provided the following statement. Cybersecurity 
review is an important system established by all Members. The main purpose is to strengthen supply 
chain security, to improve the security and controllability of CI I, and to protect national security. 
This is also a common practice by many Members. The "Cybersecurity Review Measures" were 
implemented on 1 June 2020, and the "Cybersecurity Review of Network Products and Services" was 
repealed at the same time. This ne w measure is formulated based on summarization of years of 
working practices, on the experiences of relevant systems designed in developed Members, and on 
rounds of solicitation of opinions of all stakeholders. It is not aimed at specific Members or specif ic 
enterprises.  
 
36 For previous statements follow the thread under IMS ID  533 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.4   European Union - Amendments to the Directive 2009/28/EC, Renewable Energy 
Directive (IMS ID 55337) 
2.138.   The representative of Colombia  provided the following statement. Colombia wishes to 
reiterate its ongoing concern regarding Directive (EU) 20 18/2001 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 l and use change (ILUC) shall have their contribution to the renewable energy share 
gradually reduced to 0 % by 2030.  In Colombia's view, these provisions are inconsistent with the 
national treatment and MFN obligations set out in the G ATT 1994 and Article s 2.1 and 2.2 of the 
WTO TBT Agreement.  We therefore reaffirm the arguments that have been presented at the TBT 
Committee meetings concerning this matter, 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 would be grateful if the EU could share further information on the 
internal process to review the delegated act. We once again welcome the opportunity to comment 
on this matter and note that we understand that this matter is being addressed under the WTO 
dispute settlement procedures.  
2.139.   The representative of Guatemala  provided the following statement. The systemic conce rn 
regarding this measure has been noted and will be followed up accordingly.  
2.140.   The representative of Ecuador  provided the following statement. My delegation reiterates its 
concern regarding this measure. As a signatory to the Paris Agreement, Ecuador commen ds all 
efforts to meet climate targets. This involves incentivizing the use of raw materials that are both 
more efficient and environmentally friendly. We are of the view that palm oil, when obtained in 
accordance with sustainability criteria, can meet thi s goal. For this reason, we believe that the draft 
European Directive may not effectively ensure that the targets for cutting greenhouse gas emissions 
are met and, in its current form, will have a direct effect on oil palm. Any environmental measure 
for fu lfilling the European climate agenda must be compatible with the multilateral trading system 
and should not be a means of arbitrary or unjustifiable discrimination, or a disguised restriction on 
international trade. Moreover, Ecuador continues to have conc erns regarding the ILUC methodology 
and the characterizations based on general criteria used by the EU for the certification of biofuels, 
bioliquids and biomass fuels. We are concerned that, in terms of trade, the measure favours 
vegetable oils produced in  the EU, which could contravene the principle of national treatment. For 
this reason, we would like to know on the basis of which criteria Annex V has been established. We 
are particularly concerned that the methodology in question may have a restrictive o r even 
discriminatory effect.  
2.141.   Lastly, I would like to stress that Ecuador has made significant progress in meeting its 
national targets and commitments for mitigating and adapting to climate change. It is currently a 
world leader in the implementation of p olicies, measures and actions to reduce emissions from 
deforestation and forest degradation. This national commitment has also been taken on by the 
Ecuadorian palm -growing sector, which signed an agreement aimed at moving towards sustainable, 
deforestation -free oil palm production, with a roadmap setting out concrete actions to achieve zero -
deforestation. Ecuador is the second country in the world to have met the requirements established 
by the United Nations Framework Convention on Climate Change to gain a ccess to performance -
based payments for reducing emissions from deforestation and forest degradation. Furthermore, 
this measure could have a negative socio -economic impact on the Ecuadorian palm -growing sector, 
which produced approximately 455,000 tonnes o f crude palm oil in 2019. Crude palm oil accounts 
for 3.5% of the country's agricultural GDP, representing over USD 194.34 million.  There are 
approximately 6,568 palm oil producers, of whom 88% are small producers with less than 50 
hectares under productio n and 51% are small producers in small -scale family farming with less than 
10 hectares under production. The importance of this sector lies in its socio -economic contribution 
to the country, with foreign exchange earnings from exports of around USD 216 mil lion per year, 
according to the figures for 2019. The sector accounts for some 120,000 direct and indirect jobs 
throughout the production chain.  
2.142.   In response, the representative of the European Union  provided the following statement. As 
indicated in many pr evious meetings, this issue of amendments to the EU Renewable Energy 
 
37 For prev ious statements follow the thread under IMS ID  553 (under dates raised and references) . G/TBT/M/82  
 
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  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 preserve the integ rity of such 
proceedings, the European Union will defer all discussions to that forum and accordingly refrain from 
discussing this matter in this Committee.  
2.1.3.5   India - Air Conditioner and its related Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/110  (IMS ID 59838) 
2.143.   The representativ e of the United States  provided the following statement. The United States 
remains concerned with the exclusive use of Indian standards for air conditioner (A/C) energy 
efficiency, application of separate energy efficiency requirements to component parts, and 
certification requirements by the BIS set forth in India's Air Conditioner and its related Parts, 
Hermetic Compressor and Temperature Sensing Control (Quality Control) Order, 2019 (Air 
Conditioners QCO). Many US companies use relevant international sta ndards developed by the Air -
Conditioning, Heating and Refrigeration 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 sugges ts that, to expedite availability of A/C equipment with documented 
verification testing records, BIS should also recognize, without further testing, equipment for which 
AHRI's Product Performance Certification Program has verified energy efficiency.  
2.144.   The Un ited States notes that AHRI standards can provide greater specificity 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 approach is less specific, which can cause testing results to 
vary widely due to variations in test set -up. 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 
perfor mance of each component impacting the performance of the other 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 t he overall A/C system. The 
United States understands that the choice of components in finished products is already a major 
consideration for manufacturers when designing products to meet energy efficiency requirements. 
Further, according to US industry, no  other markets or relevant international standards apply 
separate energy efficiency requirements to component parts as a method of energy efficiency 
evaluation. Additionally, if India continues to apply separate requirements to component parts, the 
United States requests that India provide an additional one -year grace period to extend the 
implementation date for compliance with the requirements for component parts to 1 January 2022.  
2.145.   The representative of the Republic of Korea  provided the following statemen t. Korea is 
grateful for suspending implementation of the regulations for seven months and accepting Korea's 
comments. However, due to corporate difficulties regarding this regulation, Korea would like to 
request the following from India. Korean companies have their manufacturing facilities not only in 
India but also in other countries to sell air conditioners to India. The factory inspection within India 
of BIS certification appears to be gradually resumed. However, the factory inspection within other 
countries from BIS was not conducted during the grace period, so the factories within other countries 
of Korean companies have faced difficulties in compliance with India regulations. Therefore, Korea 
would like to request for India to provide an additional si x-month grace period or an exemption from 
factory inspection within other countries for BIS certification until BIS certification bodies could 
perform normal duties.  
2.146.   In response, the representative of India provided the following statement. India wishes to  
inform the Members that this STC was raised in the last three meetings. A detailed reply to the 
points raised was given in the earlier response in May. However, we would like to add that the 
request to provide a grace period was already agreed. A seven -month grace period was extended. 
The said QCO, Air Conditioner, and its related Parts (Quality Control) Order, 2018, now comes into 
force from 1 January 2021. There is no plan for further extension.  
 
38 For previous statements follow the thread under IMS ID  598 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.6   Kingdom of Saudi Arabia - Electrical Clothes Dryers Energy Performance 
Requirements and Labelling, G/TBT/N/SAU/987  (IMS ID 60539) 
2.147.   The representative of the Republic of Korea  provided the following statement. Korea is 
thankful for your responses to positive reviews of our comments in the May 2020 WTO TBT 
Committee Meeting that electrical cl othes dryer energy efficiency standard (Saudi Standards, 
Metrology and Quality Organization (SASO) 2883) will be revised by the end of 2020. However, since 
that meeting, it has not been confirmed whether or not the standard has been revised. Korea would 
like to ask Saudi Arabia to share the timeline of the amendment process.  
2.148.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia thanks Korea for raising this concern and we would like to point out that 
the SASO 2883:2017/AMD2:2020 "Electrical Clothes Dryers - Energy Performance Requirements 
and Labelling " has been revised and approved by SASO board on 9 July 2020. This amendment was 
published in the Official Gazette on 4 September 2020 and reflected on th e Energy Efficiency 
Registration system (SLS).  
2.1.3.7   China - Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods (IMS ID 61140) 
2.149.   The representative of the United States  provided the following statement. The United States 
remains concerned with China's draft "Administrative Measures for Registration of Overseas 
Producers of Imported Foods " (Administrative Measures) and urges China to reconsider putting in 
place such a res trictive and burdensome regulation. The measure appears to affect all food products, 
regardless of risk or whether foods are already subject to additional import certification 
requirements, such as seafood and dairy products exported to China. Furthermore,  the draft 
measure requires foreign competent authorities to confirm that exporting manufacturers are in 
continuous compliance with China's laws, regulations, and standards. Such requirements would 
impose additional burdens on foreign competent authorities  without regard to exporting country's 
regulatory resources and legal authority. We anticipate that the draft measure, if implemented, 
would likely create major trade disruptions for every country that exports food and agricultural 
products to China, inclu ding for developing countries whose competent authorities may have limited 
capacity to meet China's proposed requirements. During the May TBT Committee meeting, China 
indicated that it was still drafting this measure. Can China provide any updates to its t imeline for 
completing the draft and notifying the measure to the WTO?  
2.150.   The representative of Brazil  provided the following statement. On top of complexifying the 
registration and supervision of high -risk food products exported to China, the draft measure a lso 
expands the scope of products subject to registration procedures. If adopted, all Brazilian food 
producers who intend to export to China would need to provide pre -export registration following 
stricter requirements. The measure also creates new burdens ome requirements related to food 
labelling. Our private sector estimates that, if applied as presented in the initial draft, the regulation 
could affect exports of meat, fish, milk, soy, sugar, animal and vegetable oil, coffee, fruits, 
vegetables, cereals,  and cocoa, with the potential to also impact beverages.  As far as we can 
ascertain, China has not published any regulatory impact assessment, risk analysis or technical 
document that presents the link between said regulation and the legitimate objectives it is willing to 
safeguard. The lack of information regarding the scientific grounds for this regulation raises concerns 
about transparency in the regulatory process undertaken by Chinese authorities. On top of that, by 
refraining from notifying the draft measure, China did not abide by its transparency obligations under 
either TBT or the SPS Agreements.  
2.151.   The Draft Administrative Measures for Registration of Overseas Producers of Imported Foods 
seems to grant discriminatory treatment towards imported food pr oducts in relation to those 
produced in China, which are not subject to the rules of such an onerous registration process. These 
procedures are more trade restrictive than necessary and they pose a great burden on producers 
and on the competent authorities  of the exporting countries, without clearly demonstrating the gains 
in terms of food safety and health promotion. We kindly urge China to consider less trade -restrictive 
alternatives that could properly address its legitimate concerns. The proposed measur e also departs 
from a relevant international standard, notably the Codex CAC / GL 38 -2001 standard "Guidelines 
 
39 For previous statements follow the thread under IMS ID  605 (under dates raised and referen ces). 
40 For previous statements follow the thread under IMS ID  611 (under dates raised and references) . G/TBT/M/82  
 
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  for Design, Production, Issuance, and Use of Generic Official Certificates ", by adopting a different 
registration model that is more costly than that contained in said standard. Therefore, we 
respectfully ask China to provide further details regarding how it plans to implement new 
burdensome requirements such as annual reports and inspections. We also urge China to consider 
defining reasonable tran sitional periods for producers and exporters to adapt to the regulation. We 
would deeply appreciate if China could present the scientific studies and risk analyses that supported 
the development of the draft measure, as well as the reasons and the technica l basis for outsourcing 
inspection responsibility to the competent national authorities. For a greater certainty, we also ask 
China to present the exact coverage of the measure, elucidating to which products the measure shall 
apply. Finally, could China al so commit to notify to the TBT Committee all of the next steps in the 
development of this regulation? Would China be able to provide time frames for the publication of 
the final regulation and its entry into force?  
2.152.   The representative of the Separate Custom s 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 updating the status of the proposed administrative measures at 
the previous m eeting. We share the same concerns expressed by other Members. As the proposed 
measure would create impacts on a very broad scope of food products and enormous burden on 
foreign competent authorities, we would like to request China to provide further infor mation on 
progress of the draft and the timeline for notifying it to the WTO TBT and SPS Committees.  
2.153.   The representative of the Republic of Korea  provided the following statement. Korea supports 
concerns raised by other Members on the draft administrative m easure. The revised administrative 
measure requires the registration of overseas producers of all imported food products. Such 
requirements would impose an enormous administrative burden and incur excessive time and cost 
on importing and exporting parties.  Although Korea supports China's legitimate purpose, "food 
safety ", applying the measure on all imported foods without scientific evidence or clear stipulation 
of processes would be more trade restrictive than necessary. Therefore, Korea believes that the 
measure should be carefully reviewed. During the last TBT Committee meeting, China mentioned its 
plan to notify the measure following the finalization of the revision to the TBT Committee. Thereby, 
Korea requests China to share the information on current r evision status and the timeline for its 
notification.  
2.154.   The representative 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 submitted extensive comments informally on the proposal and we 
would expect a revised version to be notified through WTO channels for formal consultation with 
trade partners before China undertakes any steps towards the adoption of such a f ar-reaching 
measure. As presented, the measure would bring substantial additional administrative burden for 
companies and 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 
food safety. Nevertheless, measures have to avoid unnecessary constraints. They should conform 
to WTO agreements and Codex Alimentarius guidelines.41 
2.155.   Accordingly, inspection systems should be applied to particular commodities and processing 
methods, in proportion with the associated risks. The measure covers all food and beverages 
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 -registratio n regime. The EU 
kindly requests that China explains the objective of this proposal and stands willing to discuss any 
legitimate concerns in order to find consensual solutions.  
2.156.   The representative of Mexico  provided the following statement. The delegation o f Mexico 
refers to the Draft Administrative Measures for Registration of Overseas Producers of Imported 
Foods, published by the General Administration of Customs of China (GACC)  on 26  November  2019. 
These draft 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 
Supervision, Inspection and Quarantine (AQSIQ).  Mexico submitted its concerns through the written 
procedure of the WTO TBT  Committee in May  2020, which in general refer to the following:  The 
 
41 i.e. CAC/GL 20 -1995 on principles for food import and export inspection and certification  G/TBT/M/82  
 
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  scope of the draft measures is unclear. The measures do not establish any categories or include a 
list of the products covered.  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 meaning of this 
reference (minimum sales package).  The draft measures require the competent authorities in the 
country of origin to follow an additional certific ation procedure in order to ensure compliance with 
the regulations of the Government of China.  This would represent an additional procedure for the 
Mexican authorities and for exporters, who would have to certify their products twice. The first 
procedure w ould 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 th e Mexican 
authorities and may therefore contravene the principle of proportionality provided for in Article  2.2 
of the WTO TBT Agreement.  
2.157.   The draft measures require that a specific risk assessment be carried out for the product 
before importers may be regi stered, but include no information on the scientific or technical basis 
for the determination of the proposed assessment. China also needs to identify whether the required 
risk assessment is based on an international standard.  The draft measures were not n otified to the 
members of the WTO TBT Committee, which contravenes the transparency requirements set out in 
Article  2.9 of the TBT Agreement by not allowing TBT  Committee Members to submit comments and 
take part in the process of developing the draft measu res. During the written procedure of May  2020 
of the TBT Committee, the delegation of China indicated that the measure was at the development 
stage and would be notified once it was ready.  In light of the above, the delegation of Mexico kindly 
requests the  delegation of China to:  Provide information on the current status of the measure, as 
well as on a possible date for its entry into force, the next steps to be taken or any update thereof.  
Clarify the scope of the draft measures, as well as the labelling r equirements set out therein. If 
alcoholic beverages are included in the products covered by these regulations, Mexico would be 
interested in engaging in bilateral talks with the Chinese authorities to discuss a less restrictive 
procedure with respect to im ports of certain products, such as tequila, and would like to propose the 
acceptance of a certificate of authenticity for export.  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 the development of these 
draft measures is based. More specifically, we would like to know the justification for requesting risk 
assessments for the products covered.  Comply with the transparency commitments of the TBT 
Agreement and allow for a period of public consultation for submitting comments on the draft 
measures.  The delegation of Mexico thanks the delegation of China for giving its consideration to 
this statement a nd to the requests made therein.  
2.158.   The representative of Japan  provided the following statement. Japan also shares the 
concerns on China's draft administrative measures for registration of overseas producers. Japan has 
been seriously concerned that China's p roposed measures would create unnecessary trade barriers 
and have negative impacts on food trade between China and WTO Members. The measures would 
impose an obligation on foreign competent authorities to inspect and supervise manufacturing 
companies in acc ordance with Chinese laws and regulations, and to confirm them to the Chinese 
Government. In addition, the measures would cover all food products imported in China. However, 
it is not clearly explained by China yet that the scope of the measures is set on a scientific 
assessment of the risks of each food product. The measures could be overly trade restrictive without 
scientific evidence. Japan would like to request China to submit the notification in timely manner, 
provide relevant information on this matte r as appropriate, and properly address the concerns of 
the WTO Members.  
2.159.   The representative of Switzerland  provided the following statement. Switzerland maintains 
its concerns regarding the proposed registration of overseas manufacturers of imported food an d 
would like to thank the United States, Brazil and Chinese Taipei for keeping this item on the agenda. 
We refer to previous statements for more detailed comments and call on China to consider other 
ways and means to ensure the importation of safe food pro ducts. We stand ready to engage with 
China on this matter and look forward to receiving detailed answers to our questions and comments 
submitted previously.  
2.160.   In response, the representative 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 implementation of 
registration of over seas producers of imported food is based on the requirement of the Food Safety G/TBT/M/82  
 
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  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 a re 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 core of revision is to further optimize the 
registration procedures, clarify the responsibilities of all relevant parties and facilitate the 
registration and  trade. Without repeating our statement at last meeting, I would like to refer to the 
feedback given during that meeting. I just want to highlight one point: At present, the revision of 
the "Administrative Measures for Registration of Overseas Producers of  Imported Foods " is still at 
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.  
2.1.3.8   Colombia - Food Prioritized f or its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1  (IMS ID 60942) 
2.161.   The representative of Costa Rica  provided the following statement. Costa Rica appreciates 
the opportunity to express concern regarding the proposed Colombian Technical Regulation 
establishing  the maximum sodium content for a prioritized list of a broad range of foods, such as 
tuna, chicken sausages, chorizo, salted biscuits, ham, peanuts, butter, mayonnaise, breads, pastas, 
wheat flour products, cream cheese, soups, sauces and sausages. Costa Rica agrees with Colombia's 
reasoning that it is necessary to implement strategies aimed at protecting public health through the 
reduction of arterial hypertension and related non -communicable diseases. However, it is concerning 
that the proposed maximum s odium levels for the selected products are neither substantiated by 
scientific evidence nor based on the international reference standards established under the Codex 
Alimentarius. We call on Colombia to share with Costa Rica the scientific basis and risk assessment 
supporting the sodium levels established for each product, so as to facilitate our analysis of the 
legislation. Ultimately, we are seeking compliance with the main pillar of the TBT Agreement, which 
is based on the prevention of unjustified barr iers to trade. This is particularly relevant at a time 
when our countries' economic and social recovery hinges on a guaranteed and uninterrupted flow of 
safe and affordable food.  
2.162.   The representative of the United States  provided the following statement. The  United States 
appreciates Colombia's continued engagement with the United States on their new sodium level 
requirements for various agriculture products, notified to the TBT Committee as G/TBT/N/COL/238 . 
The United States continues to support Colombia's efforts to reduce hypertens ion and related NCDs. 
However, we are concerned that the implementation of the sodium regulations appears imminent 
despite the numerous concerns raised by both WTO Members and industry stakeholders. The United 
States respectfully requests that Colombia con sider ways to incorporate our comments into the draft 
regulation. We also request that Colombia publish revision for domestic and international 
consultations prior to implementation. Studies indicate that the reformulation and product 
development cycles ge nerally take three years ahead of market readiness and required reductions 
may take two or more development cycles to maintain functionality, lifespan, and enable adaptation 
of consumer taste. Under the timelines in the currently proposed regulation, some US processed 
foods would likely be unable to meet the requirements to be sold on the Colombian market. Despite 
Colombia's responses from previous WTO TBT Committee meetings and responses to US 
Government comments, the United States still seeks clarificatio n on how Colombia will apply 
sanctions for processed foods that do not comply with the mandatory sodium reduction levels.  
2.163.   Another key concern for our stakeholders is the addition of the Certificate of Conformity to 
demonstrate compliance with the food labe l statement requirements in Colombia's technical 
regulations. Can Colombia elaborate on its response to the United States' comments in August 2020 
and provide more information on the two different certificate schemes it referenced for companies 
to demonstr ate conformity at the port of entry? The United States is concerned that provision of lot -
by-lot certificates of conformity is burdensome and costly for importers. Specifically, there are two 
areas of concern both in the duplicative nature of requiring bot h registration and certification, and 
that the new certificate requires certification lot -by-lot. The United States again requests details on 
the frequency with which these certificates will need to be issued and information on the inspection 
and confirmat ion process for these certificates. We reiterate our interest in having an open dialogue 
with your Ministry of Health, where we can learn and share information regarding ways to develop 
 
42 For previous statements follow the thread under IMS ID  609 (under dates raised and references) . G/TBT/M/82  
 
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  evidence -based programs to address Colombia's public health objectives  while minimizing negative 
economic impact.  
2.164.   The representative 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 2019 and would appreci ate any updated information on the status of the draft regulation. 
The European Union would like to note that it fully supports and shares the objective pursued by 
Colombia to reduce overall sodium intake in an attempt to contribute to the reduction of hig h blood 
pressure and other associated diseases. In the last TBT Committee meeting, Colombia replied, with 
regard to EU questions on certificate of conformity for nutritional declarations, that time frames for 
issuance, inspection and confirmation for these  certificates are not provided for in the draft 
regulation and will be established by the certification body. The EU notes that this information is 
essential for importers who need to be aware well in advance of the means to comply with the 
regulation. The refore, the EU would like to ask Colombia again for information on the period of 
validity and the verification process for the certificate. The European Union would also like to ask 
Colombia whether and under which conditions certificates issued by foreign  conformity assessment 
bodies and test results for sodium content issued by foreign laboratories would be accepted. 
Furthermore, the EU would welcome clarifications as to the type of sanctions that would be imposed 
to non -compliant products following the d ate of entry into force of the regulation.  
2.165.   The representative of Guatemala  provided the following statement. The technical regulation 
seeks to establish the maximum sodium content for the food prioritized under the National Strategy 
for the Reduction of So dium Consumption, with the aim of contributing to the reduction of arterial 
hypertension and related non -communicable diseases, and with the legitimate objective of 
protecting the health of the Colombian population.  Guatemala wishes to thank Costa Rica, th e United 
States and the European Union for including this item on the agenda . We recognize the legitimate 
objective of the Colombian authorities to ensure human health, and the efforts made to reduce 
hypertension . The notified technical regulations establi sh a maximum sodium content for certain 
processed foods.  Guatemala remains concerned about the conformity assessment proposed in the 
draft regulation . The pre -packaged food industry, whether products are domestic or imported, 
complies with a significant nu mber of technical regulations and is constantly monitored by the 
Colombian Government, including in respect of the sanitary registration and distribution of products . 
Certificates can only be issued by certification bodies, and sodium content can only be d etermined 
through a laboratory analysis . This "third -party conformity certificate" requirement is considered to 
be a barrier to international trade . Furthermore, the tolerance established in the draft technical 
regulation is very low, and Guatemala therefo re hopes that the limits for various foods will be 
reconsidered.  
2.166.   Guatemala is also concerned about the lack of harmonization of the limits with other public 
policy instruments, such as the nutritional information that must be displayed on the labels of 
pre-packaged foods . The maximum sodium content must be consistent with front -of-package 
advisory labelling thresholds.  At the TBT Committee meeting in May this year, Colombia once again 
made it clear that the sale of products exceeding the established maximum  sodium content was not 
banned, since the companies responsible for such non -compliance would be punished . However, if 
the measure is analysed, it can, in practice, be considered a sales ban, as companies will not want 
to receive a penalty every time non -compliance is reported.  We wish to reiterate that this is a matter 
of concern for economies such as Guatemala's . The lack of harmonization of the trade regulations 
issued by Colombia, together with the lack of clarity regarding the country's international trade 
facilitation measures, limits the ability of small and medium -sized Guatemalan producers to access 
its market.  
2.167.   In response , the representative of Colombia  provided the following statement. Our 
authorities have received various comments and observations from several  trading partners, w hich 
are being reviewed . We have also been in close contact  and shared information with a number of 
delegations and industry re presentatives . We can report that the draft regulation on maximum 
sodium content  in processed foods has not ye t entered into force and the conten t of the standard is 
still being assessed in capital by the various competent authorities.  G/TBT/M/82  
 
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  2.1.3.9   Russian Federation - Law No. 425 - on Amending Article 4 of Russian Federation 
Law "On Protecting Co nsumer Rights" (IMS ID 61243) 
2.168.   The representative 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 -installati on of Russian software on "technically complex 
goods " (TCGs) sold in Russia. While we recognize that Russia has postponed the implementation 
deadline until 1 January 2021, due in large part to the coronavirus pandemic, many concerns and 
questions remain. W e presented 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 productio n methods for TCGs sold in Russia – namely 
that these devices must contain certain software which must be pre -installed. Law No. 425 -FZ 
therefore appears to meet the definition of a technical regulation. If Russia does not agree, please 
explain why the req uirement is not a technical regulation.  
2.169.   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 TCGs targeted by this technical regulation already feature software from 
Russian developers and include app platforms which encourage participation by Russian companies.  
Does Russia have evidence that Russian developers are being denied access to develop software for 
TCGs? 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 a sk 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 comment s 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 mon ths 
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.  
2.170.   The representative of the Europea n Union  provided the following statement. The European 
Union has concerns on amending article 4 of the Russian Federation Law "On Protecting Consumer 
Rights". These concern mainly certain discriminatory aspects as well as the proportionality of the 
measure . We call on Russia to comply with its WTO obligations and notify the measure to the TBT 
Committee. We are also looking forward to receiving the answers to the questions raised by the US 
delegation.  
2.171.   The representative of Japan  provided the following statem ent. 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 for review and evaluation, and the 
scope of regulations including cove red 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. Therefore, 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 relevant 
regulations to the TBT Committee to ensure transparency of t he procedure.  
2.172.   In response, the representative of the Russian Federation  provided the following statement. 
Russia reiterates its statements made during the previous meetings of the Committee on TBT. We 
do not consider this measure to be a technical regulati on as it does not comply with the definition 
provided in the Annex 1 of the TBT Agreement. The measure does not set any prohibitions or 
restrictions for installation of foreign software, nor does it impart or establish  any requirements on 
de-installation o f any pre -established software, whether Russian or foreign, and applies equally to 
both Russian and foreign TCGs.  
 
43 For previous statements follow the thread under IMS ID  612 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.10   India - Quality Control Orders for Chemical and Petrochemical Substances, 
G/TBT/N/IND/116 , G/TBT/N/IND/121 , G/TBT/N/IND/122 , G/TBT/N/IND/123 , 
G/TBT/N/IND/124 , G/TBT/N/IND/125 , G/TBT/N/IND/126 , G/TBT/N/IND/127 , 
G/TBT/N/IND/128 , G/TBT/N/IND/129 , G/TBT/N/IND/130 , G/TBT/N/IND/132 , 
G/TBT/N/IND/133 , G/TBT/N/IND/134 , G/TBT/N/IND/135 , G/TBT/N/IND/136 , 
G/TBT/N/IND/137 , G/TBT/N/IND/138 , G/TBT/N/IND/139 , G/TBT/N/IND/140 , 
G/TBT/N/IND/141 , G/TBT/N/IND/142 , G/TBT/N/IND/144 , G/TBT/N/IND/150 , 
G/TBT/N/IND/151 , G/TBT/N/IND/152 , G/TBT/N/IND/153 , G/TBT/N/IND/154  (IMS ID 
63044) 
2.173.   The representative of the United States  provided the followi ng statement. We understand 
that on 22 October 2019, the Ministry of Chemicals and Fertilizers (MoCF), Department of Chemicals 
and Petrochemicals circulated a notice that invited industry stakeholders to discuss with MoCF its 
proposed plan to make BIS stan dards mandatory for 72 identified chemicals and petrochemicals. 
We are also aware that, beginning in November 2019, India's MoCF has notified 27 QCOs in 27 
separate notifications to the WTO TBT Committee. We greatly appreciate India's notification of these  
27 QCOs to the WTO TBT Committee, and we thank India for providing stakeholders with the 
opportunity to submit comments in response to these QCOs. We are aware that each QCO appears 
to identify substances that correspond to or fall under one of the 72 sub stances identified in the 
October 2019 meeting notice, and that each QCO proposes to mandate compliance to BIS standards 
for the identified substance. We kindly request that India provide links to how WTO Members can 
access these BIS standards identified  in the 27 notified QCOs.  
2.174.   We also request that India include links to standards as posted to the BIS site identified in 
any future QCO that India plans to notify as part of its efforts to mandate conformity to BIS standards 
for chemicals and petrochemicals. Because the notified QCOs do not currently include text or links 
to available BIS standards that they propose to mandate, interested parties, including industry 
stakeholders, have no consistent way to access and are unable to become fully acquainted with t he 
QCOs. Furthermore, the referenced standards are not often posted to the BIS website. We encourage 
India to notify and provide opportunities for public comment for any future QCO that India plans to 
notify as part of its efforts to mandate BIS standards for chemicals and petrochemicals. We 
encourage India to provide an update on how it intends to use Government orders to mandate 
conformity with the BIS standards as part of India's standards and conformity assessment regime. 
We request that India explain h ow it will engage with international stakeholders in developing its 
mandatory technical requirements as part of its conformity assessment regime. We encourage India 
to consider existing international standards when revising BIS standards and to recognize r elevant 
international standards, where they exist, as a basis for meeting Indian requirements. Are any of 
the QCOs notified now final? We encourage India not to adopt final measures until it has notified 
any revisions to the draft measures to the WTO TBT C ommittee and taken into account comments 
from interested parties.  
2.175.   The representative of the European Union  provided the following statement. The European 
Union would like express its concern over the visible trend towards mandatory domestic standards 
in India that deviate from international ones in a growing number of sectors. In this case, they 
pertain to a w hole range of chemical products under the HS chapters 28 and 29. Within less than a 
year (i.e., between April 2019 and July 2020), India has made to the WTO 29 notifications concerning 
chemical products. Of these, 20 are covering petrochemicals (Combined N omenclature (CN) chapter 
29), including such important mass products like methanol, toluene, styrene, ethylene glycol, acetic 
acid, terephtalic acid, acetone and melamine, and another nine deal with inorganic chemicals (CN 
chapter 28). The EU would like to  remind the authorities of India that in accordance with the TBT 
Agreement, standards are considered voluntary, whereas mandatory standards are considered as 
technical regulations. The EU notes that for practically all the chemicals concerned by these 
notifications, there are neither international standards, nor technical regulations imposed in other 
countries. Furthermore, the Indian standards which are being rendered mandatory had already been 
in place for long periods (sometimes even for decades), which makes it difficult to understand the 
reason for changing their status, all at once, within such a short period of time. The EU fears that it 
will be easier to enforce the requirements on imports than on local manufactured products and thus 
the measure coul d potentially be discriminatory in nature.  
 
44 For previous statements follow the thread under IMS ID  630 (under dates raised and references) . G/TBT/M/82  
 
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  2.176.   The EU would like to recall Article 2.2 of the TBT Agreement, according to which Members 
shall ensure that technical regulations are not prepared, adopted or applied with a view to or with 
the effect of creating u nnecessary obstacles to international trade. The EU would like to encourage 
India to align the BIS standards with international approaches. The Indian Government is already a 
leader in promoting harmonized application of the United Nationals Globally Harmo nized System of 
Chemical Classification and Labelling (GHS). Best practices could be leveraged in working with key 
trading partner countries, to coordinate an inclusive and efficient development of new chemical 
management rules. It is also of critical impo rtance to ensure the mutual recognition of data 
generated under different regulatory schemes in other jurisdictions and avoid unnecessary animal 
testing. This is in alignment with the OECD MAD (Mutual Acceptance of Data) Agreement, to which 
India is a sign atory, which states that there should be no requirements for test laboratories to be 
certified by a government agency nor for laboratories to perform tests in the country of registration.  
2.177.   The representative of Canada  provided the following statement. Canad a reiterates the 
concerns it raised at the May 2020 Committee meeting concerning all "QCOs " on chemical and 
petrochemical substances notified by India since November 2019. These prospective measures 
would make mandatory the use of Indian Standards on the n otified substances. Acknowledging the 
offer made by India in this Committee to discuss, bilaterally, any other issue Members may have on 
this measure, Canada reached out to India's Enquiry Point to seek to advance discussions on this 
STC. To date, its requ est for clarification remains unanswered. Nevertheless, on account of the 
nature of its concerns with India's proposed measures, Canada thinks that open and transparent 
discussions on this STC at the TBT Committee would better serve the interests of intere sted WTO 
Members and stakeholders. The approach followed by India in notifying the measures generates 
significant concerns vis -à-vis the obligations of the TBT Agreement, notably Articles 2.2 and 2.5, as 
they avoid providing interested parties and stakehol ders a genuine consultation period to review the 
measures and provide comments. The notifications lacked any attempts to explain the new 
measures, except for the statement that "the Central Government […] is of the opinion that it is 
necessary or expedient  so to do in the public interest ". As per Article 2.5 of the TBT Agreement, can 
India explain to WTO Members the justification behind this "opinion […] in the public interest " and 
its link to the new measures?  
2.178.   The notifications also lacked supporting docum entation that would explain the stated 
objectives of the proposals, i.e., to ensure "health, safety and environment for prevention of 
deceptive practices and national safety ". As per Articles 2.2 and 2.5 of the TBT Agreement, can India 
explain to WTO Membe rs: (i) how its previous regulatory environment was lacking with regard to 
health, safety, environment, and – specifically – "national safety "; (ii) how the proposed measures 
will meet the above -mentioned objectives; and (iii) how India's proposed approach  is not more trade 
restrictive than necessary to achieve these objectives, including the risk of non -fulfilment? 
Declarations of the new mandatory nature of the Indian Standards were made without facilitating 
stakeholders' access to any related information  on them, including direction on where one could find 
the latest official version of the Standards, some of which are decades old. Has India conducted a 
comprehensive review of those standards prior to ensure they reflect current methods of production 
before seeking to make them mandatory? Canadian stakeholders are concerned that these new 
measures and the lack of clarity surrounding them could seriously undermine the ability of foreign 
chemical manufacturers to access the Indian market. The new permit requ irements will add a 
significant level of bureaucracy for both industry and Indian regulators, and could reasonably be 
expected to result in significant delays in the import process. India previously confirmed that the 
"certification period [of 1 year] has been prescribed in the Bureau of Indian Standards (Conformity 
Assessment) Regulations, 2018 and would not be feasible to change. " Canada, again, requests 
additional clarification on the steps India has taken to ensure the capacity of its administrative 
authorities to effectively implement and enforce the new measures, as well as deliver the new 
permits in a timely manner.  
2.179.   Canada has serious concerns with the opaque method of notification followed by India, which 
has been repeated a number of times in all "QCOs" notified since November 2019. Canada recognizes 
and strongly supports Members' right to regulate. However, Members must ensure that such actions 
do not create unnecessary obstacles to international trade, and follow internationally agreed -upon 
rules a nd processes to ensure a level playing field and the viability of the international trading 
system. The lack of transparency, justification, and overall clarity displayed here goes against this 
international regime.  G/TBT/M/82  
 
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  2.180.   The representative  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 responding positively to our concerns at the previous meeting 
on the draft orders regarding the mandatory requirements for a number of chemical and 
petrochemical substances, which basically involve the bearing of the Standard Mark under a license 
from the BIS. Among the notified measures, we are particularly concerne d about the one for 
Terephthalic Acid (notified in G/TBT/N/IND/124  on 31 March 2020). We would like to seek 
elaboration and clarification from India on issues that are still of our concern, which mainly involve 
the obligations stated in Articles 5.1.1 and 5.1.2 of the TBT Agreement  that conformity assessment 
procedures shall be non -discriminatory and shall not be more strict or be applied more strictly than 
is necessary. As the new mandatory certification unavoidably increases trade cost and uncertainty, 
we are still concerned about  the necessity of this draft order. India indicated in its notification 
(G/TBT/N/IND/124 ) and response that the objective of the new Order is to "keeping in view the 
health, safety and environment for prevention of deceptive practices and national safety. " We would 
like to ask Indi a to elaborate on the reasons for changing the voluntary certification to mandatory, 
in particular information on the risk assessment that supported such a change.  
2.181.   The likely discrimination against imported products and/or foreign manufacturers of this 
draft Order is of concern to us. According to Scheme -I of Schedule -II of India's BIS Conformity 
Assessment Regulations 2018, some of the requirements will significantly increase the burden and 
costs for foreign products vis -à-vis their domestic Indian counter parts. Firstly, the certification 
requires product testing and annual factory visit. The certification/licence is valid only for one year 
for initial application, and one to five years for renewals. We are concerned over the very short 
validity of the cert ification that will make it more difficult, if not impossible, for foreign manufacturers 
to apply for a renewal only 12 months after the issuance date. We seek India's clarification of the 
rationale behind this design and how this requirement can be applie d to both domestic and foreign 
applicants on a non -discriminatory basis taking into account the practical difficulties faced exclusively 
by foreign manufacturers. Secondly, according to India's response, BIS does not recognize nor 
accept third -party testin g reports from laboratories outside India. As this creates a significantly 
higher burden for manufacturers located outside India, we seek India's reasons for this non -
recognition/non -acceptance. To this end, we once again call for India to consider providi ng 
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.  
2.182.   Thirdly, we are highly concerned with the requirement for ann ual "on-site" factory 
visit/inspection, a costly requirement to fulfil especially for manufacturers located outside India. As 
the BIS Conformity Assessment Regulations 2018 stipulates that "the need for carrying out the 
inspection shall be decided keeping in view the risk associated with ", we seek further information 
from India on the risk assessment underpinning the new Order's decision that there is a need to 
carry out annual factory visit/inspection no matter whether it applies to initial application or renewal 
proceedings. In particular, we call for India to share with Members the risk factors and other reasons 
that prevent India from adopting less trade -restrictive alternative approaches. Another point we 
would like to bring to India's attention is the impact of COVID -19 on the implementation of the BIS 
Conformity Assessment Regulations 2018 especially for the requirement of factory visit or on -site 
inspection. As more countries are expected to impose travel bans or restrictions to control the spread 
of COVID -19, this pandemic will amplify the challenges for foreign producers to comply with the said 
Regulations. We would like to suggest that the Indian authorities consider temporary measures to 
authorize qualified inspection bodies located in the exportin g Members (e.g. inspection bodies 
accredited under ILAC -MRA framework) to facilitate factory inspections in lieu of Indian delegation 
to mitigate the problem. The India inspecting agency can still participate remotely through video 
conference and/or supple mentary document reviews. In summary, we urge India to inform other 
Members how the non -discrimination principle is observed and the necessity of this requirement in 
accordance of Articles 5.1.1 and 5.1.2 of the TBT Agreement. In particular, we call for In dia to share 
with Members the risk factors and other reasons that prevent India from adopting less trade -
restrictive alternative approaches. We would be grateful if the above -mentioned comments could be 
taken into account and replied to before adoption of the notified draft.  
2.183.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to make some comments regarding this regulation as follows. First of all, Korea thanks India for 
the six -month suspension of the Acetone QCO,  which resolved the difficulties of Korean enterprises. 
In addition, Korea is pleased to hear the announcement from India regarding the document to be G/TBT/M/82  
 
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  uploaded to the official website soon in response to item 2.1.2.20   45 regarding Phthalic Anhydride  
QCO. However, Korea would like to make requests as Korean companies have the following difficulty 
with regard to the enforcement date of Potassium Carbonate QCO, 2020 of Ind ia. Although the 
enforcement date of Potassium Carbonate QCO is scheduled to take effect in December 2020, Korean 
companies have completed the application for certification, but the acquisition of certification 
including factory inspection has been delayed  because COVID -19 has made it difficult for BIS to 
perform their duties normally. Therefore, Korea requests India to postpone the implementation of 
Potassium Carbonate QCO for more than three months in consideration of the delay in certification 
process du e to COVID -19. 
2.184.   The representative of Singapore  provided the following statement. Singapore would like to 
register its concerns over India's notified QCOs relating to chemical and petrochemical substances. 
The QCOs would make mandatory the conformity of a s eries of chemicals and petrochemicals to 
Indian Standards. Singapore is concerned that some of the QCOs appears to be more trade 
restrictive than necessary and could undermine foreign chemical manufacturers' access to the Indian 
market. There are technical  specifications and testing requirements that appear to be unique to 
India. Singapore encourages India to consider referencing available international standards in its 
requirements. Singapore also notes that on -site factory visits and inspections are requi red as part 
of the certification process. Given the on -going COVID -19 pandemic, there would be limitations in 
arranging for on -site visits, particularly for factories that are located outside of India. In light of the 
above, Singapore seeks India's reconsi deration on the application of mandatory certification to BIS' 
standards for chemicals and petrochemicals. If that is not possible, Singapore would like to request 
for India to delay the entry into force of the QCOs, to allow for an appropriate transitiona l period 
and to avoid unnecessary impacts to trade. Singapore looks forward to having a bilateral discussion 
on the matter.  
2.185.   The representative of Japan  provided the following statement. Japan shares the concerns 
regarding "QCOs for Chemical and Petrochemic al Substances " expressed by the US, EU, Canada, 
Chinese Taipei and Republic of Korea. Japan understands that India will make 72 chemicals and 
petrochemicals standards into technical regulations by introducing a permit system. Japan would 
like to request th at India ensure that these technical regulations are to be introduced in a manner 
consistent with the TBT Agreement, especially in terms of not being more trade restrictive than 
necessary to fulfil its legitimate objectives.  
2.186.   In response, the representative  of India provided the following statement. India issuing 29 
QCOs for chemicals and petrochemicals of HS chapters 28 and 29 is not a deviation from 
international practices. As per Article 2.2 of the TBT Agreement, Members are allowed to formulate 
Technical  Regulations. The standards are made mandatory for products of mass consumption, 
including the downstream industries, to fulfil legitimate objectives of: national security requirements, 
prevention of deceptive practices, protection of human health and safe ty protection of animal and 
plant life and preservation of the environment. As per the laid down procedure, the draft QCO has 
been displayed on the WTO  TBT website, giving enough and open opportunity to the Members to 
share their objections within 60 days.  It is pertinent to note that even if other countries have not 
formulated TR's for such chemicals, the number of TRs of chemicals and petrochemicals in India is 
less than in other nations. For a long time, the Indian standards of chemicals and petrochemica ls 
were voluntary. The trade of chemicals and petrochemicals usually occurs as per the specifications 
settled between the manufacturer and buyer irrespective of the specifications stipulated in the BIS 
standard, which sometimes resulted in dumping inferior  quality chemicals into India. Many chemicals 
are toxic and hazardous. The impurities such as heavy metals, cyanides, isocyanates, halides, etc. 
enter the human and plant chain, thereby harming human and animal life. Under mandatory 
standards regime, safe,  reliable, and quality chemicals will be available.  
2.187.   TRs for chemicals and petrochemicals are formulated not to create unnecessary obstacles to 
international trade. It is pertinent to mention that the TBT Agreement permits making the standards 
mandatory, an d other countries are also following this practice. Both domestic and foreign 
manufacturers should comply with the provisions of the BIS Act, 2016. To align with the international 
standards, the BIS studied the available international standards before fina lizing the Standards  
under discussion. The aspect of unnecessary animal testing and the element of Mutual Acceptance 
of Data is being looked into under India's current Chemicals (Management and Safety) Rules 
formulation process. The request for postponemen t of the enforcement date of QCO of Phthalic 
 
45India - Phthalic Anhydride (Quality Control) Order, 2019 (IMS ID 660).  G/TBT/M/82  
 
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  Anhydride, and Potassium Carbonate is under examination. India is keen to keep transparency in 
the matters relating to the issuance of QCOs. India has notified 22 QCOs on WTO TBT site. It is 
possible that India may make more standards of chemicals and petrochemicals mandatory. However, 
it is not possible to provide an indicative list of chemicals and petrochemicals proposed to be covered 
under mandatory standards in the future.  
2.188.   India has formulated an individual standard of specific chemical indicating discreet  and 
separate numbers under the BIS Act, giving technical characteristics and details of testing methods. 
Since each chemical has a different BIS standard number, possesses other characteristics and other 
testing methods, India has not preferred to file a single comprehensive mandatory notification. 
Standards are made mandatory after having a consultation with manufacturers, consumers of 
chemicals, and petrochemicals. WTO Members are informed through the disp lay of notification on 
the TBT site. The Department of Chemicals and Petrochemicals (DCPC) has notified the draft QCOs 
on chemicals and petrochemicals under the provisions of the BIS Act 2016 and Rules and Regulations 
framed thereunder, which envisages con formity assessment Scheme -1 of BIS (Conformity 
Assessment) Regulation 2018. As per draft QCOs, the product specified therein shall conform to the 
corresponding Indian Standard and shall bear the standard mark under the BIS's licence as per 
Scheme -1, mentio ned above. This QCO is equally applicable to domestic and foreign manufacturers 
who intend to export their products in India. Under the provisions of the BIS Act 2016, no person 
shall manufacture, import, distribute, sell, hire, lease, store, or exhibit fo r sale chemicals and 
petrochemicals notified in the QCO without a standard mark, except for a valid licence. For persons 
selling these chemicals without a requisite certificate (licence), penal provisions of the BIS Act 2016 
shall be applicable. The violat ors shall be prosecuted as per the Act and are punishable with fine or 
with imprisonment also. The requirement for the use of Standard Mark as per Scheme -1 is given in 
BIS (Conformity Assessment) Regulations 2018. A copy of the same is available on the BI S website 
(www.bis.gov.in ). 
2.189.   The BIS is already providing its services under Foreign Manufacturers Certification Scheme, 
and more than 1,000 licences have been granted, which are operative in 50 countries. Under the 
provisions of Scheme -1 of BIS (Conformity Assessment) Regulation 201 8, the licence can be granted 
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. Under the provisions of Scheme -1 of BIS (Conformity 
Assessment) Regulation 2018, BIS grants a ma nufacturer a licence based on a successful 
assessment of a manufacturer's manufacturing infrastructure, production process, quality control, 
and testing capabilities via a visit to its manufacturing premises. The  conformity of the product to 
the relevant s tandard is also established through third -party laboratory testing located in India or 
testing in the manufacturing premises or a combination of both. There is no provision under Scheme -
1 of BIS (Conformity Assessment) Regulation 2018, to accept quality co ntrol assessments conducted 
by foreign firms and laboratories. As per QCOs on chemicals and petrochemicals, every product shall 
conform to corresponding Indian standards specified there and shall bear the standard mark under 
BIS's licence as per Scheme -1 of BIS (Conformity Assessment) Regulation, 2018. The BIS reviewed 
the standards of chemicals and petrochemicals which were notified by DCPC, and due consideration 
was given to international standards like ISO/ASTM, where available.  
2.1.3.11   India - Draft Chemicals ( Management and Safety) Rules, 2020 (IMS ID 62246) 
2.190.   The representative of the United States  provided the following statement. The United States 
appreciates India's efforts to engage with both the US Government and US industry on the Draft 
Chemicals (Manageme nt and Safety) Rules ( "Draft Rules "). We thank India for its 26 December 2019 
response letter in which the MoCF committed to notify the Draft Rules, provide stakeholders at least 
60 days to submit comments, and to take comments into account before finalizi ng the measure. The 
United States respectfully requests that India provide an update clarifying when the Draft Rules will 
be notified to the WTO TBT Committee. We ask that India also notify any subsequent versions of the 
Draft Rules that contain substantiv e changes, as well as any related implementing measures, 
including those pertaining to the process for public consultation and appeals of substance 
classifications. We strongly encourage India to evaluate risk -based approaches to identify and 
prioritize ch emicals for regulatory action, and we echo industry's concerns about the Draft Rules' 
inclusion of 750 chemicals, classified as Priority Substances, without public consultation on either 
the inclusion of these substances or the methodology used to identify  them.  
 
46 For previous statements follow the thread under IMS ID  622 (under dates raised and references) . G/TBT/M/82  
 
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  2.191.   We welcome India to consult with our agency of competency, the US Environmental 
Protection Agency (EPA), on matters of interest (for example, the matters highlighted by US industry 
stakeholders in their comments). We note that the broad criteria use d by the proposed risk 
management system could affect many products, such as cosmetics, pharmaceuticals, toys and 
agricultural pesticides, which are already regulated in India under other relevant regulations. For 
example, the safety of cosmetics and their  ingredients is regulated by the Central Drug Standards 
Control Organization, in coordination with the Bureau of Indian Standards. Can India confirm that 
current approvals/registrations (for products including cosmetics, pharmaceuticals, toys, and 
agricult ural pesticides) under existing Indian regulatory frameworks will remain valid? Can India 
clarify how the Draft Rules' notification requirements apply to downstream users and whether 
exemption of certain sectors or products from the Draft Rules would apply  to all the requirements 
(registration, notification, authorization, labelling, etc.)? The Draft Rules appear to exempt 
substances in articles which are produced at levels below a certain number of tonnes per annum, 
but do not specify this de minimis threshold (described in Section 3(4)(a) as "[tons per annum").  
Can India provide the number of tonnes per annum below which exemptions will be granted? How 
is this threshold calculated?  
2.192.   The representative of Canada  provided the following statement. Canada under stands that 
the Draft Chemicals Rules are now in their fourth and "final" iteration, and have only been shared 
with a select group of stakeholders and business associations so far. This situation creates a major 
asymmetry between those who have had access to the Draft Chemicals Rules and were able to 
influence their development, and those who will discover the extent of the Draft Chemicals Rules 
only once they are published. Canada urges India to notify the draft rules as soon as possible in 
order to ensure  that all interested parties are given sufficient time to review and provide comments, 
and ensure that sufficient time is allowed after the consultation period for Indian authorities to give 
due consideration and responses to those comments. Is India in a position to share with the 
Committee a timeline for the publication and consultation period of the Draft Chemicals Rules?  
2.193.   Due to the novelty and complexity of the Draft Chemicals Rules, and their potential to disrupt 
trade, Canada also supports a long tran sition period to give stakeholders the time they need to 
prepare. This will be essential, considering that some stakeholders have been given an advantage 
by being consulted on four iterations of the Draft Chemicals Rules, while the intricacies of the new 
rules remain unknown to the rest of the world. Stakeholders will need time, resources and capacity 
to implement the new rules appropriately, and a phased implementation period could help ease the 
transition. Canada urges India to make its regulatory process  more open, transparent and 
collaborative, and to take the necessary time to work with all stakeholders and all WTO Members to 
assist them in understanding the full impact of the Draft Chemicals Rules.  
2.194.   In response, the representative of India provided the following statement. India would like 
to thank the US and Canada for its interest in the matter. India would like to inform the Members 
that the Draft Chemicals (Management and Safety) Rules 2020 is still under circulation among the 
industry associations f or extensive stakeholders consultation, which is entirely internal. Once the 
draft gets finalized, it will be notified to WTO TBT Committee for circulation to Members, providing 
them the opportunity to comment within a reasonable time.  
2.1.3.12   European Union - Draft Commission Regulation amending Annex III to 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards 
botanical species containing hydroxyanthracene derivatives , G/TBT/N/EU/702  (IMS ID 
62847) 
2.195.   The representative of Mexico  provided the following statement . The delegation of Mexico 
refers to the concern regarding the Draft Commission Regulation amending Annex  III to Regulation 
(EC) No  1925/2006 of the European Parliament and of the Council as regards botanicals species 
containing hydroxyanthracene derivativ es, which was notified to TBT Committee Members in 
document G/TBT/N/EU/702 . The delegation of Mexico thanks the European Union for the comments 
received in reply to the observations submitted in the public consultation process.  Notwithstanding 
the replies received, the delegation of Mexico reiterates the concerns it has raised in this forum 
regarding the proportionality of the measure and its potential impacts on the trade of products 
containing or derived from aloe or aloin.  The draft regulations proposed by the EU might prove to 
be a measure more restrictive than necessary in view of the legitimate objective pursued, 
 
47 For previous statements follow the thread under IMS ID  628 (under dates raised and referen ces). G/TBT/M/82  
 
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  considering that it would involve an absolute ban on the use of aloe and its extracts in food and 
beverage formulas. The implementation of this measure would adversely i mpact the Mexican 
industry that produces and exports to the European Union a variety of products for human 
consumption containing aloin, a component naturally found in aloe vera.  In addition to reiterating 
our concern, we request that the European Union re consider the need to implement such a measure, 
until such time as it is supported by sufficient scientific evidence.  The delegation of Mexico thanks 
the delegation of the European Union for giving its consideration to this statement and to the 
requests mad e therein.  
2.196.   The representative of the Dominican Republic  provided the following statement. The 
European Union has submitted draft legislation amending Annex III to Regulation (EC) 
No. 1925/2006 of the European Parliament and of the Council as regards botanical species containing 
hydroxyanthracene derivatives (HAD s), a substance that occurs naturally in aloe vera. This  draft 
legislation could have a negative impact on export s of aloe ver a by-products or industrialized 
products containing aloe vera exported by the Dominican Republic to the European market . The 
Dominican Republic wishes to take this opportunity to voice its concern that the E uropean Union has 
failed to notify the draft in q uestion to the WTO Committee on Sanitary and Phytosanitary Measures . 
It was, however, notified to the Committee on Technical Barriers to Trade in 
document  G/TBT/N/EU/702 . Article VII of the Agreement on Sanitary and Phytosanitary Measures 
requires  Members to notify their provisions in order to ensure transparency.  There are t wo major 
aloe vera produc ing firms , Sábila SRL and Universal Aloe SAS (Forever Living), operat ing in the 
Dominican Republic  under the free zone regime. In 2019, the  total value of their  exports reached  
USD 8,805,4 31, while this figure was USD 4,851,466 for the  period  from January to August 2020. 
The two firms' cumulat ive investment stood at  USD 9,226,800 in 2019. Furthermore , according to 
trade statistics from firms in the country's free zone, 83% of aloe vera prod ucts that are exported 
go to the European market.  
2.197.   The US firm Universal Aloe SAS (Forever Living) is considered to be the global market leader. 
For over 30 years, it has owned approximately 3,000 hectares of land, with over 20 million aloe vera 
plants , located within  the Dominican Republic 's border area. The firm has been the economic 
backbone  of a marginalized and deprived area of the country . It has created 550 direct and 
some  3,000 indirect jobs, thereby having a positive impact on more than 800 families. The firm 
exports aloe vera gel to the United States for processing and re -export to 150 countries . Fourteen 
containers are currently exported each week for an approximate value of USD 12 mill ion per year. 
The European Union is the main market for the parent company , Forever Living.  The legislation 
amending Annex III to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council 
as regards botanical species containing hydroxyant hracene derivatives  states that : "In its Scientific 
Opinion of 9 October 2013 on the scientific substantiation of a health claim related to 
hydroxyanthracene derivatives and improvement of bowel function, the European Food Safety 
Authority  (EFSA)  concluded  that hydroxyanthracene derivatives in food can improve bowel function, 
but advised against long -term use and consumption at high doses due to potential safety concerns 
such as the danger of electrolyte imbalance, impaired function of the intestine and dep endence on 
laxatives . Plants containing hydroxyanthracene derivatives […] are widely used in food supplements 
and herbal medicinal products for their laxative effect ." 
2.198.   Based on the information provided, the Dominican Republic requests that the following 
factors be taken into consideration : Parts of the plant containing HAD s: Aloe vera  leaves are 
composed  of three layers : (i) a thick , green outer rind; (ii) a thin layer of yellow latex containing 
HADs; and (iii) an inner layer of clear, thick, and moist gel containing nutrients.  Therefore, the part 
of the plant with the lowest concentration of the substance under  investigat ion by the EFSA  is the 
aloe vera gel, which is  the part used by the firm Universal Aloe. The HAD s are found in the yellow 
latex, which  is used to produce laxatives.  Production processes: Some companies use the yellow 
latex to produce laxative medicines or food supplements, while others, such as Forever Living , use 
only the inner gel for its juice . In other words, it is possible to adopt prod uction processes that 
involve removing the outer green rind and the yellow latex, thereby reducing the HAD content to a 
level even lower than that found in common vegetables such as cabbage and rhubarb . A cheaper 
alternative process also exists, which involves grinding and then filtering the entire aloe vera plant. 
While filtering is necessary because the entire plant, including the parts containing HADs, is crushed, 
the process does result in a reduction in nutrient content . Annex III to Regulation (EC ) No. 
1925/2006 of the European Parliament and of the Council on the addition of vitamins, minerals and 
certain other substances to food comprises three parts : Part A: Prohibited Substances;  Part B: 
Restricted substances; and Part C: Su bstances under commu nity scrutiny . G/TBT/M/82  
 
- 50 - 
 
  2.199.   Given that certain parts of the plant contain minimal HAD levels, which are  even lower than 
those found in some vegetables, and that it is possible to use only part of the plant in the production 
process, we are of the view that the ban is a  disproportionate measure . This is especially the case, 
since EFSA studies show that scientific uncertainty persists. In other words, there is no evidence of 
scientific value to support or justify the ban that the European Union is seeking to impose. For t his 
reason, the amendment to the Regulation is more restrictive than necessary and constitutes a barrier 
to trade . The Dominican Republic considers that, in the absence of risk -based scientific studies from 
the European health authorities, a thorough analy sis of hydroxyanthracene tolerances in aloe vera 
gel is needed. Moreover, a scientific investigation should be conducted to test for and confirm any 
harmful impact on DNA and potential carcinogenic effects . Furthermore, it is necessary to define and 
make a  distinction between the terms "extract" and "juice". Certification should be available for 
juices that meet international standards. A longer transition period of at least three years is also 
required so that national productive sectors can adjust and ada pt. As aloe vera and its by -products 
form part of our country's exportable supply and these products enter the European market with 
tariff preferences granted under the Economic Partnership Agreement between the European Union 
and CARIFOR UM, the implementa tion of this ban would have significant adverse effects, which would 
not be limited to reducing the Dominican Republic's exports to the European market . 
2.200.   The Dominican Government is of the view that, given the international COVID -19 pandemic, 
it is not the right time to change market dynamics and requirements. The pandemic has had a severe 
negative impact on industries, which are operating with fewer staff and at reduced capacity, resulting 
in a fall in sales and revenue . The Dominican Republic recognizes th e European Union's right to apply 
measures to protect human health. However, we recommend considering equally effective 
alternative provisions, such as inspections of production sources, with a view to confirming the 
existence of products developed without  hydroxyanthracene derivatives  and establishing maximum 
levels for this substance in the development of aloe vera based products . Lastly, the measures that 
the E uropean Union is seeking to implement constitute provisions subject  to the Agreements  on 
Techni cal Barriers to Trade (TBT) and Sanitary and Phytosanitary Measures (SPS). They w ould thus 
run counter to  a number of provisions under these Agreements, specifically Articles  5.1.2, 2.1 and 
2.2 of the TBT Agreement and Article VII of the SPS Agreement , amo ng others . 
2.201.   In response, the representative of the European Union  provided the following statement. As 
explained in detail at the TBT Committee meeting in May, the proposed draft measure is based on 
the scientific advice of the European Food Safety Authorit y (EFSA) and on extensive consultations 
with member States and all interested parties. The 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. Besides the TBT notification, the draft measure was published for 
a seven -week consultation period. The EU has carefully analyzed all the comments received. The 
measure has been revised to clarify that it is possible during manufacturing to remove  HADs from 
the botanical extracts, but impurities of these substances may still be present. In this context, the 
EU Reference Laboratory on mycotoxins and plant toxins (EURL) was asked for assistance in 
establishing a validated analytical method and its li mits of quantification for HADs in different 
botanical preparations, including Aloe preparations. On the basis of the report of the EU Reference 
Laboratory, the European Commission held a technical discussion with member States on 28 
September 2020. The Co mmission presented the results of that discussion and of a targeted 
stakeholder consultation to member States at the last meeting of the Standing Committee on Plants, 
Animals, Food and Feed. The Committee agreed on harmonized limits of quantification for H ADs, 
including aloins , to address industry concerns regarding impurities and ensure a harmonized 
enforcement of the future rules.  
2.1.3.13   European Union - Organic production and labelling - Maté (erva -mate), 
G/TBT/N/EU/738  (IMS ID 52448) 
2.202.   The representative of Brazil  provided the following st atement. Brazil regrets having to raise 
STC 524 again. Brazil had raised this STC for the last time in the TBT Committee meeting of 
November 2019, in which the European Union stressed that erva -mate was not within the scope of 
the current organic Regulatio n (Regulation (EC) 834/2007) and there was no possibility to modify 
this. However, the EU noted that, as proposed by the European Commission, the new Regulation 
(EU) 2018/848 on organic production and labelling adopted on 30 May 2018 by the European 
Parlia ment and the Council included Maté under its scope. The new regulation would enter into force 
 
48 For previous statements follow the thread under IMS ID  524 (under dates raised and references) . G/TBT/M/82  
 
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  on 1 January 2021. In September 2020, the EU notified a proposal for a regulation of the European 
Parliament and of the Council amending Regulation (EU) 2018/848 on organic production as regards 
its date of application and certain other dates ( G/TBT/N/EU/738 ). Following its adoption, instead of 
entering into application on 1 January 2021, Regulation (EU) 2018/848 will enter into application on 
1 January 2022. The postponement of the entry into force of Regulation (EU) 2018/848 shows the 
EU's disregard towards the matters presented by Brazil under this long -standing STC. As we have 
stated in previous meetings, not including erva -mate in the organic product list without any technical 
or scientific justification was discriminatory and more trade restrictive than n ecessary, and thus 
inconsistent with the TBT Agreement. Until January 2022, provided that no further postponements 
will be enacted, Brazilian producers will be denied access to EU markets on an equitable basis, and 
their losses are not expected to meet any  sort of compensation.  
2.203.   In response, the representative of the European Union  provided the following statement. 
The European Union notes that it has replied to Brazil on this issue in previous TBT Committee 
meetings, as well as bilaterally. As previously ex plained, Erva -Mate is not within the scope of the 
current EU Regulation on organics (Regulation (EC) 834/2007) and there is no possibility to modify 
this. However, as proposed by the European Commission, the new Regulation (EU) 2018/848 on 
organic producti on and labelling adopted on 30 May 2018 by the European Parliament and the 
Council includes Erva -Mate under its scope. The new organics Regulation was due to enter into 
application on 1 January 2021. Nevertheless, following the on -going COVID -19 crisis, th e organic 
sector needed additional time to adapt to the new rules on production, controls and trade. For this 
reason, the EU recently notified to the TBT Committee a draft Regulation , for adoption and 
publication before the end of 2021, postponing the entr y into application of the organics Regulation  
by one year ( G/TBT/N/EU/738 ). The European Union acknowledges Brazil's written comments on 
this TBT notification. The new organic rules will enter into application on 1 January 2022.  
2.1.3.14   European Union - Hazard -based approach to plant protect ion products and 
setting of import tolerances, G/TBT/N/EU/383 , G/TBT/N/EU/384 , G/SPS /N/EU/166 , 
G/SPS /N/EU/166/Add.2  (IMS ID 39349) 
2.204.   The representative of Costa Rica  provided the following statement. As on previous occasions, 
Costa Rica would again like to reiterate its support for the trade concern raised by the United States, 
Canada and Australia. As we have stated on numerous occasions at this Committee's previous 
meetings, we are concerned about the hazard -based approach adopted by the European Union (EU). 
In our view, under the obligations of the multilateral system, all technical requirements must be 
based on the relevant international reference standard or a risk assessment providing the scientific 
evidence to support the measure. We once again urge the EU to ensure that the implementation of 
its regulations is based on the use of risk assessments thr ough the application of criteria supported 
by sufficient scientific evidence, in line with the commitments established in the TBT Agreement.  
2.205.   The representative of the United States  provided the following statement. The United States 
takes the floor to reit erate concerns on endocrine disruptors, which many WTO Members have 
expressed at previous TBT Committee meetings without any satisfactory response from the EU. The 
EU has stated that it will conduct risk assessments for maximum residue levels (MRLs) and im port 
tolerances for substances triggering its hazard criteria; however, this does not appear to be the 
case. The EFSA does not set risk endpoints even for substances for which other authorities, including 
Codex, have successfully completed risk assessments  and set MRLs. The EU's hazard criteria, 
including its endocrine disruptor criteria, have been in place since November 2018. Since that time 
the EU has not renewed approval of active substances without completing a consumer dietary risk 
assessment, pointin g to the potential of the substance to fit in its hazard criteria. As we conveyed 
previously, we have serious concerns about the scientific underpinnings, non -discrimination, 
transparency, and predictability in application of the EU's process. We are troub led that these 
concerns have gone so long unaddressed and ask the EU when it will respond to our questions, with 
clarity and specificity.  
2.206.   The representative 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 and nutritious food, 
especially during these uncertain times, is paramount. As stated during past TBT C ommittees, 
Canada is concerned with the EU's approach to decision making for plant protection products, and 
 
49 For previous statements follow the thread under IMS ID  393 (under dates raised and references) . G/TBT/M/82  
 
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  particularly the impact of these decisions on trade of agricultural commodities and setting of import 
tolerances. Canada is keen to understand how d ecisions by the European Commission to cancel the 
authorization of a plant protection product, that is deemed to meet the hazard -based cut -off criteria, 
will affect import tolerance (IT) requests made in accordance with the procedures laid down in 
Regulati on (EC) No. 396/2005. It also remains unclear how the EU will take into consideration risk 
assessment techniques developed by relevant international organizations when a plant protection 
product has already been determined to meet the hazard -based criteria  for the purpose of ITs. 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 t o participating in this information exchange when circumstances 
permit. We trust that these events will provide sufficient detailed information to clarify and address 
our concerns.  
2.207.   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, 
maximum residue limits for active substances whic h are not re -authorized in the EU should be 
maintained at existing levels to allow trade to continue. We look forward to continuing our 
engagement with the EU and hope that regulatory changes arising from any new policy will be 
implemented in a coherent an d transparent way that will minimize unnecessary barriers to trade 
and provide sufficient time to allow producers and exporters to make timely business decisions.  
2.208.   The representative 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 potential for harm (hazard) 
due to the intrinsic properties of a chemical. Australia thanks the EU for its comments at the previous 
TBT meeting and would welcome any updates on the procedures for handling requests for import 
tolerances for active substances falling under the "cut-off" criteria in Regulation (EC) No 1107/2009.  
2.209.   The represent ative of Brazil  provided the following statement. Brazil would like to refer to 
its previous statements regarding STC 393. As  many WTO Members have pointed out, the EU has 
systematically refused to take into account concerns raised by many WTO Members rega rding 
notifications G/TBT/N/ EU/383  and G/TBT/N/EU/384 . We emphasize that regulations on endocrine 
disruptors should be established according to sound scientific principles, taking all available data 
into consideration. Serious evaluations must be able to separate 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 fulfil 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.  
2.210.   The representative of Colombia  provided the following statement. Colombia once again 
shares the concern raised regarding  the approach taken by the EU for identifying substances with 
endocrine -disrupting or carcinogenic properties.  As we have stated across different items on  various 
occasions in this Committee, we reiter ate the need to use risk analysis and scientific evidence as 
methodical tools for making decisions under the three components of assessment, management and 
communication.  The EU's action shows that risk assessment is losing ground, with its decision s to 
accept or allow the use of substances being taken  using  a hazard -based approach , disregarding  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 evidence, 
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 m easure, in order to avoid creating an unnecessary technical barrier to trade.  
Given that this specific trade concern has been raised repeatedly on numerous occasions in this 
Committee, we would respectfully like to ask how these observations are being take n into account , 
and would appreciate receiving further information fro m the EU on how decisions on the approval of 
the use of plant protection substances are taken and how maximum residue limits for products are 
defined.  
2.211.   The representative of Guatemala  provided the following statement. Guatemala reiterates its 
concern regarding the matter of endocrine disruptors and the hazard -based approach . The 
importance of the general risk analysis framework needs to be recognized (this includes risk 
assessment, risk ma nagement and risk communication).  The precautionary principle is justified G/TBT/M/82  
 
- 53 - 
 
  when potentially negative effects are identified, available scientific data is assessed and there is 
growing scientific uncertainty.  We would like to reiterate the importance of usi ng risk analysis for 
import tolerances, particularly for tropical developing countries, where climatic conditions differ from 
those in the EU, in that we do not have a harsh winter to help control pests.  We urge the European 
Union to establish measures tha t do not unnecessarily restrict trade.  
2.212.   The representative of Ecuador  provided the following statement. We thank Australia, 
Canada, Costa Rica and the United  States for once again including this specific trade concern on the 
Committee's agenda. We echo their concerns and refer to our previous statements on this matter. 
We w ish to once again reiterate our trade and systemic concern relating to the EU's use of a hazard -
based approach, instead of risk assessments with criteria supported by sufficient scientific evidence, 
in line with the commitments set forth in the TBT Agreeme nt. 
2.213.   The representative of Uruguay  provided the following statement. We wish to support the 
comments made by the preceding Members and reiterate our trade and systemic concern relating 
to the European Union's use of a hazard -based approach, instead of an ap proach based on full 
scientific risk assessments, when making regulatory decisions concerning the authorization of active 
substances used in plant protection  products and when setting import tolerance levels for substances 
that meet the cut -off criteria in  its corresponding regulations.  We firmly believe that regulatory 
decisions should be based on evidence from an assessment of the actual risks associated with plant 
protection products, taking into account their exposure. Otherwise, such products may be wi thdrawn 
despite their safe use and significant role in pest management systems. 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.  In this regard, we concur with Canada that now 
more than ever we should ensure and facilitate people's access to safe and nutritious food, produced 
in acc ordance with good agricultural practices.  
2.214.   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 o f health while facilitating international trade in food products. In the 
meantime, we once again urge the E uropean Union to give due consideration to the concerns 
expressed and to reconsider its regulatory approach, with a view to preventing the unjustifie d 
proliferation of barriers to international trade in agricultural products and the serious soci o-economic 
consequences of such an approach for other Members, in particular developing and least developed 
countries, for whom t he European Union  is an importa nt market . Like other Members, we are still 
waiting for the European Union to announce that it will hold the seminars and information sessions 
that it has promised, at an appropriate time and in an appropriate format given the current situation, 
to continu e exchanging information on this matter . 
2.215.   The representative of Paraguay  provided the following statement. In the interest of time, 
this statement will cover five trade concerns, which we consider to be linked:  No. 40 – EU: 
Precautionary principle ; No. 43 - EU: Transitional periods50; No. 44 – EU: chlorothalonil51; 
No. 47 - EU: mancozeb52; and  No. 58 - EU: Picoxystrobin53. The hazard -based approach adopted by 
the European  Union (EU) is the source of these concerns, which we will address jointly here in a 
single statement. The lack of risk assessment continues to increasingly limit the use of plant 
protection products and reduce MRLs to trade -restrictive levels, the argument being that it is 
impossible to determine whether the use of many substances is safe du e to a lack of conclusive 
scientific evidence, even in cases where the Codex Alimentarius has identified certain substances as 
being safe.  At the same time, there is still a lack of clarity over the import tolerance procedure, even 
though the EU has indica ted on many occasions that the procedure will be conducted on a 
case-by-case basis and that "other legitimate factors", which have yet to be defined by the EU, will 
be taken into consideration. Moreover, the EU has announced in its Farm to Fork Strategy th at 
environmental factors will be taken into account when considering such tolerances, yet when faced 
 
50 European Union - Transitional periods for MRLs and international consultations (IMS ID 580)  
51 European Union - chlorothalonil (pesticide active substanc e) (IMS ID 579)  
52 European Union - Non-renewal of the approval of the active substance mancozeb (IMS ID 627)  
53 European Union - Regulation (EC) No 1107/2009 - non-renewal of approval of the active substance 
picoxystrobin (IMS ID 535)  G/TBT/M/82  
 
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  with requests for information on how this will be done, it has failed to provide the necessary 
information.  
2.216.   In addition, the EU's transitional period does not allow enough time for the adaptation of 
entire production systems and, in practice, allows more time for EU producers than for producers in 
the EU's trading partners. We have heard the EU turn down repeated requests to extend the 
transitional peri ods, claiming that this would compromise its level of protection and the health of its 
consumers. However, since the implementation of these regulations began, emergency 
authorizations allowing European producers to continue using these substances in spite  of the ban 
have increased exponentially, according to the EU's own data. We wonder how to reconcile these 
concerns, which, on the one hand, do not allow a few more months to be provided  to foreign 
producers , yet, on the other, do allow already banned prod ucts to continue being used, for up to 
three months for each emergency approval, with no cap on the number of times that such approvals 
may be renewed.  With regard to the specific substances on various items of today's agenda, we 
would like to reiterate th e following:  As we stated in the written procedure that was carried out at 
the end of May, mancozeb is an active substance that has been in use for over 50 years and continues 
to be considered an important tool in controlling certain types of fungi through out the world. 
Mancozeb is used on more than 70 types of crops and for controlling over 400 diseases. Producers 
in my country use it to control soybean rust, which affects soybeans. Withdrawing this product from 
circulation, given the lack of substitutes w ith the same properties, we run the risk of not only 
increasing the use of other fungicides during productive cycles, but also of reducing their efficacy. 
This would negatively impact production yields in my country, which, unlike other countries, does 
not subsidize farming or have the resources to compensate farmers for their losses.  
2.217.   We recall that the most common substitute for mancozeb is chlorothalonil, a low -risk 
substance sold freely in Paraguay. It is used on various exports, as part of the rotation of substances 
to avoid pest resistance, and has suffered the same fate as mancozeb, despite both substances not 
posing any risks to human health or the environment if used in accordance with good agricultural 
practices.  Picoxystrobin, which is also used on  various export crops, is another tool used in the 
rotation of plant protection products that we will also have to withdraw due to further implementation 
of decisions that do not take into account the risk factor. In total, out of the approximately 350 
substances that have been or are currently being reviewed, 116 are used as the main or 
complementary tool in fighting pests in Paraguay, a country whose climatic conditions, and therefore 
pest-pressure levels, are very different to those of the EU.  Although we share the objectives that 
the EU seeks to achieve with these policies, we do not agree with the method used to achieve them, 
as it is not based on scientific evidence.  
2.218.   Consequently, we deeply regret the EU's lack of openness to dialogue, as sh own by the 
following:  (i) The continued inclusion of such trade concerns on the agenda and the proliferation of 
new concerns in response to the pursuance of such policies;  (ii) The refusal to delay the amendment 
and revision of MRLs for plant protection pr oducts, contained in communication 
G/TBT/GEN/296/Rev.4 ; (iii) The avoidance of concrete answers to direct questions raised in the SPS 
and Agriculture  Committees and during trade policy reviews;  (iv) The response that we received 
from the Permanent Representation of the Euro pean Union to our request to establish broad and 
comprehensive dialogue to address these and other trade concerns in various WTO Committees; 
and lastly,  (v) The fact that the EU submitted all its answers to these concerns yesterday, without 
first listening  to Members' statements today.  The pursuance of such policies will cause significant 
trade damage to the economies of developing countries and jeopardize their ability to achieve 
sustainable development goals, including those related to food security.  We urge the EU to reassess 
its approach in these exchanges; base its decisions on conclusive scientific evidence and real risk 
weights, in accordance with the relevant international principles and standards; ensure import 
tolerances and, where necessary, provi de adequate transitional periods.  
2.219.   In response, the representative of the European Union  provided the following statement. 
The European Union thanks the WTO Members for their interest in the on -going work in the EU on 
identifying endocrine disruptors for pl ant protection products. As informed in previous TBT 
Committee meetings, the scientific criteria to identify endocrine disruptors for plant protection 
products based on the World Health Organization (WHO) definition are applicable since 10 November 
2018 on wards and included in Regulation (EU) No 2018/605. The European Union is aware of general 
concerns on the EU policy on plant protection products for the definition of scientific criteria to 
identify endocrine disruptors. We are also aware of concerns on th e establishment of import 
tolerances for substances that are not authorized in the EU, due to the so -called "cut-off" criteria in G/TBT/M/82  
 
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  Regulation (EC) No 1107/2009. As previously explained, the European Union decided to follow the 
procedures of 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 EFSA. 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 abou t further developments.  
2.1.3.15   Indonesia - Halal Product Assurance Law No. 33 of 2014, G/TBT/N/IDN/123  
(IMS ID 50254) 
2.220.   The representative of the United States  provided the following statement. 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 its response to the US Government and US 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 
in May 2019 Indonesia finalized and issued Government Regulation 31 of 2019 on "Implementation 
Provisions of Law 33/2014 regarding Halal P roduct Assurance " related to the Halal Law, which 
Indonesia has not notified to this Committee. We understand that the MORA has also issued Decree 
no. 464, a positive list for products requiring halal certification. In October 2020, the United States 
sent a request to Indonesia's Enquiry Point requesting that Decree no. 464 be notified to this 
Committee as an addendum to G/TBT/N/IDN/123 . We ask that Indonesia respond to that request 
and reiterate our previous request that Indonesia notify all implementing measures related to the 
Halal Produce Assurance legislation to the Committee.  
2.221.   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 following 
list of products are in the scope and the envisioned timeline for the requirements to enter into force? 
October 2024 for "food and beverage products "; October 2026 for "traditional medicine and health 
supplements ", "cosmetics, chemical product and genetically engineered pr oducts ", "clothing, 
headgear and accessories ", "household appliances, Muslim worship equipment, stationery and office 
equipment ", and "goods for medical devices risk class A "; October 2029 for "over-the-counter (non -
prescription) medicines " and "goods for medical devices risk class B "; October 2034 for "prescription 
medicines, excluding psychotropic " and "goods for medical devices risk class C"; and there is  
currently no date specified for biological vaccines and goods for medical devices risk class D. We 
also await clarification about the status of proposed legislation connected with the following 
category: "Medicinal product, biological product and medical equipment made from non -halal raw 
material or non -halal processing, " as listed in the notificatio n 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 pro duct categories.  
2.222.   We understand that on 5 October, Indonesia finalized an Omnibus Job Creation Bill that 
modifies the original Halal Law. Will there be further implementing guidance forthcoming based on 
these changes? We request further information regardin g Indonesia's response to US Government 
comments regarding required labelling for non -halal products. Can you refer us to the applicable 
regulations for food and cosmetics from Indonesia's National Agency of Drug and Food Control 
(BPOM/NADFC) that are refe renced in Indonesia's response? We also ask that the aforementioned 
BPOM/NADFC regulations for cosmetics be notified and opened up for comment, if they will result in 
new labelling requirements not currently in force for US cosmetics imported into Indonesi a. In 
developing these requirements, we ask that Indonesia consider the industry and US Government 
comments previously submitted expressing concerns as to the feasibility and necessity of requiring 
that all categories of covered products have separate manu facturing, 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 products co nsidered 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 bulk shipm ents. 
 
54 For previous statements follow the thread under IMS ID  502 (under dates raised and references) . G/TBT/M/82  
 
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  2.223.   We request that Indonesia provide sufficient transition time for stakeholders to understand 
and comply with the requirements in these regulations. We understand that the MORA implementing 
regulation will allow for phased implementation of mandatory H alal certification requirements 
between 2024 and 2034 and that Indonesia will continue to allow the sale of non -certified products 
until the deadline for each category is reached. Can Indonesia confirm our understanding? We would 
like to thank Indonesia fo r previously extending the recognition of foreign Halal certification bodies 
so that Halal -certified agricultural products can continue to enter Indonesia uninterrupted during 
this transition time. However, while all five US -based Halal certifiers have sta rted the application 
process to renew recognition of their Halal certifications, they have received only minimal feedback 
on their applications. Meanwhile, recognition of one of the five certifiers expired on 5 June 2020. To 
ensure the continuation of trad e, we request that Indonesia again extend recognition of all five US -
based Halal certifiers for another two years to prevent trade disruptions for Indonesian industry 
while the Halal Product Assurance Agency (BPJPH) streamlines its recognition application process. 
We understand there is also an online registration requirement for each product certified by a foreign 
Halal certification body, including a requirement that the certificate registration numbers be included 
on the product label. We request that In donesia remove or modify this requirement to reflect the 
fact that Indonesia's Halal Product Assurance Agency ( "BPJPH ") already conducts verification audits 
of those foreign Halal certification bodies.  
2.224.   As written, the registration requirement for importers  is also cumbersome and duplicative. 
Could this online registration be done by foreign Halal certification bodies instead of by importers? 
Would you confirm that products that received their Halal certification inside of Indonesia would 
already be register ed as part of the domestic Halal certification process and therefore would not 
need to use the online registration system? We ask that Indonesia provide greater specificity as to 
which medical devices will be subject to the Halal Law's implementing regulat ions. We also ask 
Indonesia to clarify their response to the US medical device industry request to exclude from the 
scope of the Halal Law in -vitro diagnostic products made of animal material which are used to test 
human blood, saliva and tissue samples th at are not subsequently returned to the human body. We 
are encouraged by Indonesia's notification of the MORA regulation and urge Indonesia to notify all 
previous and forthcoming implementing regulations in their draft form prior to their finalization and 
again request transparency as these rules are developed to provide adequate transition time, and 
an opportunity for stakeholder comments. Would you confirm that haram (non -Halal) vaccines will 
be permitted as long as there is no equivalent Halal vaccine av ailable for the same medical condition 
with comparable safety, efficacy and quality profiles? What will the process be to ensure this?  
2.225.   The representative 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 and its implementing provisions, which require mandatory Halal certification 
and labelling for a very wide range of products to be placed on the Indonesian market. The EU 
regrets that, contrary to Article 2.9 of the TBT Agreement, Indonesia failed to notify the Halal Law 
and Implementing Regulation No 31/2019 to the TBT Committee. The EU acknowledges the TBT 
notification of Implementing Regulation 26/2019 on the Facilita tion of Halal Product Assurance and 
Regulation 31/2018 on Processed Food Labelling and invites Indonesia to reply to the comments 
submitted, respectively, on 27 April and 12 May 2020. The EU is aware that Indonesia is in the 
process of adopting the Omnibus  Bill on Job Creation, including provisions on the Halal certification 
process and invites Indonesia to notify the Bill to the WTO. The EU refers to its statements in previous 
TBT Committees stressing the excessive restrictive impact on trade of the propos ed Halal measures 
and firmly calls upon Indonesia to reconsider its approach and keep Halal certification and labelling 
voluntary, limiting its effects to the legitimate objective of ensuring reliable information.  
2.226.   In particular, the requested "non-Halal" information for non -Halal products, the extension of 
Halal requirements to products other than food and beverages or the need for a cooperation 
agreement between foreign Halal certification bodies and the Indonesian Halal Products Assurance 
Agency (BPJPH) a s a pre -condition for recognition of Halal certificates represent an excessive burden 
for economic operators. The additional registration requirement for Halal certifications issued by 
foreign bodies appears to be duplicative and time consuming. The EU ins ists that Indonesia accepts 
test reports from EU laboratories accredited by a body member of the international arrangements 
for mutual recognition of the ILAC and the International Accreditation Forum (IAF). The EU calls 
Indonesia to consider less -restrict ive measures and to inform Members on the status of Halal 
implementing provisions.  G/TBT/M/82  
 
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  2.227.   The representative of Canada  provided the following statement. Canada would like to thank 
Indonesia for its engagement on this issue. However, we would like to reiterate tha t Canadian 
exporters still require additional information on how the Halal Product Assurance Law will be 
implemented in order to successfully comply with its requirements. Canada looks forward to 
receiving additional clarification from Indonesia on what th e term "toxic" means vis -à-vis grains, 
fruits and vegetables that must be certified Halal if they are "toxic". Canada appreciates Indonesia's 
assurances that the Halal law will not ban the sale of non -Halal products in Indonesia nor require 
non-Halal produ cts to be certified. In our view, it would be beneficial for importers to have this 
specification made clear in the implementing regulations for the Halal Product Assurance Law. We 
remain concerned with the mandatory requirement for providing information o f non-Halal ingredients 
on product packages. In our view this could be difficult for manufacturers to implement. Canada 
would appreciate if Indonesia could clarify the type of information that will be required on non -Halal 
food packages. If a food does not  display a mark for Halal it should be assumed to be non -Halal. 
Canada has yet to receive the requested 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 
regulation and will therefore require Halal certification and labelling.  
2.228.   This requirement could disadvantage imported products that must be frozen in order to 
maintain freshness during transport and cause confusion among consumers. Canada exported close 
to CDA$43 million  worth of frozen crabs and other frozen seafood to Indonesia in 2019. Can 
Indonesia explain how the freezing process makes a crab or blueberry non -Halal, based on its 
certification standards? Is there any form of freezing that can be undertaken that keeps a crab or 
blueberry Halal, and if so, could Indonesia explain what modifications to the process or other 
requirements are necessary? While we note that Indonesia remains open to international cooperation 
with foreign Halal institutions or authorities, the product accreditation process for foreign Halal 
certifying organizations 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? Will further guidance be notified to the TBT 
Enquiry Point and, if so, will a public comment period be provided?  
2.229.   Canada encourages Indonesia to provide timely information as further implementing 
regulations are developed to provide trading partners with sufficient time to comment and seek 
clarifications as needed. We understand that the outstanding applicat ion of a Canadian certification 
body that we raised during the last Committee meeting is being processed. Canada would like to 
thank Indonesia for moving ahead with the review of this application. However, this process 
reinforces a concern that Canada has previously raised – how will Indonesia engage with countries, 
such as Canada, that rely on successful non -governmental accreditation organizations to oversee 
Halal certification? The Regulation of the Minister of Religious Affairs of the Republic of Indone sia 
concerning the Operation of the Halal Product Guarantee Article 24 states that it is possible for 
accreditation institutions in other countries that have gained recognition in regional or international 
accreditation organizations to accredit a Canadian  certification body. What is the acceptable 
alternative to a proof of accreditation from a local standards agency?  
2.230.   The representative of Brazil  provided the following statement. Brazil would like to thank 
Indonesia for the clarifications provided in its st atement regarding STC 502 in the previous TBT  
meeting. Brazil attaches great importance to the regulatory process aiming to implement Halal 
Product Assurance Law 33 (2014). We will continue to support this STC so as to keep track of any 
upcoming regulatory  progress on the subject.  
2.231.   The representative of Australia  provided the following statement. Australia welcomes on -
going discussions on the Indonesian Halal Product Assurance Law no.33 of 2014 (Halal Law), and 
continues to seek for the law to be implemented  transparently and in close communication with 
businesses and trading partners. We encourage Indonesia to continue to facilitate an open dialogue 
with trading partners to allow foreign businesses and their valued Indonesian importers to remain 
adequately i nformed of Halal Law implementation regulations. Australia welcomes further dialogue 
on the Halal Law to ensure its implementation is no more trade restrictive than necessary.  
2.232.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank Indonesia for its on -going engagement to date regarding this matter. In reference to 
Article 29 paragraph (2), New Zealand continues to seek further guidance on the timeframe for 
release of the ministerial decree that will stipulate the  type of products that must be Halal certified. G/TBT/M/82  
 
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  We ask for some clarity on the status of Halal Certification Organizations whose certification will 
soon expire or has already expired with Majelis Ulama Indonesia (MUI), and whether there are any 
transitory arrangements in place for them to continue to certify before 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 d evelopment, 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 unde rstand that the Omnibus Bill will require regulatory amendments 
under 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.  
2.233.   In response, the re presentative of Indonesia  provided the following statement. Indonesia 
would like to reiterate its previous statement that the implementation of Halal certification is effective 
in accordance with the article 33 of the Draft of MORA as notified previously i n this Committee. In 
preparing the implementation of the Halal certification, which will take effect in 2024 for the first 
stage, implementing provisions are currently being developed and reviewed, taking into account 
comments and inputs from stakeholders.  In addition, the Draft of MORA that has been notified 
through G/TBT/N/IDN/123  as one of the implementing provisions of Halal Law is yet to be enforced 
as the draft also undertakes review process at this time. Another implementing provision of the Halal 
Assurance Law is the Decree of MORA 464 which regulates all type of products that are mandatory 
to be halal certified. This Decree is also currently under review to consider comments and inputs 
from stakeholders. Hence, this regulation is also yet to come into effect.  
2.234.   In accordance w ith Law No 33 of 2014 Chapter III on Halal Product Materials and Processes, 
materials used in halal process consist of raw materials, processed materials, additives, and auxiliary 
materials. The aforementioned materials may come from animals, plants, micro bes; or materials 
produced through chemical processes, biological processes, or genetic engineering processes. 
Materials derived from animals are basically Halal, except those that are prohibited according to the 
Islamic Sharia Law. Based on this, the mate rials used for Halal products must be free from haram 
contaminants in accordance with Islamic Sharia law and should not cause harm to human health. 
Indonesia reaffirms its openness to international cooperation 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. 
Product registration is a common procedure applied in many countries for alm ost all products. This 
procedure aims to ensure traceability and facilitate supervision of the circulation of Halal products. 
For more detailed concerns and enquiries, we invite Members of this committee to make all 
necessary communications through Indones ia's WTO TBT Enquiry Point.  
2.1.3.16   China - Draft revised Encryption Law of the People's Republic of China by the 
Office of State Commercial Cryptography Administration (OSCCA) (IMS ID 53455) 
2.235.   The representative of Japan  provided the following statement. Japan cont inues to have 
concerns regarding China's "Encryption Law " that entered into force on 1 January 2020 and would 
like to refer to the previous statement which we made at the last TBT Committee in May 2020. Japan 
would like to request that China's regulation n ot hamper foreign companies' activities or market 
access to China.  
2.236.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate its concern on the Cryptography Law that came into force on 1 January 2020. The 
EU remains concerned about the wide scope of the law, in conjunction 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. Th e EU notes with concern that the new 
law does not recognize 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 Clarif ication" by the SCA. 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 proper ty. Regulatory 
procedures related to products containing cryptographic components should be transparent, 
predictable and consistent with international practices. The EU urges China to guarantee the 
possibility for foreign invested enterprises (FIEs) to par ticipate on an equal footing with domestic 
 
55 For previous statements follow the thread under IMS ID  534 (under dates raised and references) . G/TBT/M/82  
 
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  companies in the production, research, development and sale of cryptography products on its 
market.  
2.237.   The representative of the United States  provided the following statement. The United States 
supports the other Me mbers raising this STC, and we refer to our previous statements on this 
measure. We continue to be concerned about the implementing regulations on Encryption Law for 
China and we hope that China will notify any implementing measures.  
2.238.   The representative of Canada  provided the following statement. Canada would like to refer 
to its statement made at the November 2019 TBT Committee meeting, as recorded in paragraph 
2.95 of document G/TBT/M/79.  
2.239.   In response, the representative 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-discrimination, 
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 cooperation 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 
meas ures. 
2.1.3.17   European Union - Transitional periods for MRLs and international consultations 
(IMS ID 58056) 
2.240.   The representative of Costa Rica  provided the following statement. As in previous meetings, 
Costa  Rica associates itself with the concern raised by the Unit ed States, Colombia and Indonesia, 
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 substances 
used in agricultural production is a source of huge concern for Costa Rica. As previously stated, it is 
impossible for agricultural production to adjust to new requirements or tole rances within six months, 
when the registration of new molecules alone must undergo a complex assessment process lasting 
much longer than that period. Furthermore, in the current historical context in which the 
international community finds itself due to t he COVID -19 crisis, the implementation of more 
restrictive measures or additional burdens on international trade in agricultural products constitutes 
a challenge that is hampering worldwide economic recovery efforts, especially in developing 
countries. In this regard, we would like to remind the EU of the request made 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.  
2.241.   The representative of the  United States  provided the following statement. We share the 
concern that the EU transition measures do not provide adequate time for producers to modify their 
pest management programmes to clear the channels of trade. We recall previously raised concerns  
that trading partners do not know with certainty the impact of the non -renewal decision on future 
MRLs, nor can foreign growers make informed decisions on their food production practices in the 
present. Foreign growers who comply with existing EU MRL stan dards 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 regulatory provisions. Once again, the United States reiterates its request 
that the EU conduct full risk assessments prior to setting new 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.  
2.242.   The representative of Colombia  provided the following statement.  Colombia wishes to 
reiterate its grave 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 substances 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 
 
56 For previous statements follow the thread under IMS ID 580 (under dates raised and references) . G/TBT/M/82  
 
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  producers in Latin America n countries . In this context, we reaffirm the arguments put forward and 
compiled in document G/TBT/W/695  of 13 November  2019. The uncertainty faced by agricultural 
producers related to short transition periods raises concern . These measures create additional 
burde ns for agricultural 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  and harvest  cycles as, while complying with European 
standards at the time of sowing , they may face regulatory changes that prevent exports at the time 
of harvest and distribution of the product . The same challenges arise in processed and frozen foods . 
For such products, short tr ansition 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 b y the future 
date on which they arrive at the border.  
2.243.   Moreover, the situation that has arisen as a result of 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 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 reducing their ability to  analyse draft regulatory measures and adjust production 
methods accordingly, creating additional burdens on international trade in food products, which is 
hampering worldwide economy recovery efforts, especially in developing countries.  In line with the 
statements made in communication G/TBT/GEN/296/Rev.3 , currently supported by 39 Members, we 
request the EU to temporarily suspend review processes of market approvals for plant 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 notification 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 Committee that could lead to changes or 
adjustments to proposed regulations.  
2.244.   Therefore, within the framework of this Committee, it cannot be acceptable for the Eur opean 
Union to  state that , as soon as the EFSA recommendation and PAFF Committee opinion are known, 
countries should be able to "make the relevant adjustments", given that this information has not 
been notified to the WTO and therefore the public consultat ion period has not expired.  In accordance 
with the provisions of Articles 2.5 and 2.12 of the TBT Agreement, Colombia considers that there 
should be further technical discussions , taking into consideration the arguments and technical, 
scientific and econom ic evidence  submitted by the Members concerned , to review the time periods 
for bringing into force the regulatory changes to MRLs, in order to prevent them from becoming 
unnecessary barriers to trade.  Colombia once again welcomes the opportunity to express  its 
concerns on this issue and looks forward to a response from the European Union.  
2.245.   The representative of Indonesia  provided the following statement. Indonesia thanks Costa 
Rica, the United States, Colombia, Brazil, Guatemala, Uruguay, Ecuador, El Salvado r, Panama, and 
Paraguay for raising this issue and shares the same concern regarding EU regulation on Transitional 
Periods for MRLs and International Consultations. However, Indonesia is of the view that this 
measure is more stringent than necessary and ha s 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 less  restrictive than necessary. Furthermore, Indonesia urges EU to align with the existing 
internationally accepted risk assessment approach as stated in Article 2.4 of TBT Agreement in order 
to remove the obstacles to trade. Indonesia as a developing country  establish es the standard s and 
regulation s based on Codex MRLs for pesticides that  has been approved by all the member countries. 
Indonesia would also like to request the EU to provide a sufficient transition period especially for 
developing countries to a dapt to the EU policy on MRLs of pesticides.  
2.246.   The representative of Brazil  provided the following statement. Brazil supports the concerns 
raised by the US, Costa Rica, Colombia and Indonesia, and we would like to refer to our previous 
statements regarding STC 580. 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 reasonable 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 an adequate transitional period, especially for those cases in which the scientific 
opinions of the EFSA on the toxicity of substances are "inconclusive" or only indicate a "suspected G/TBT/M/82  
 
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  risk". In 2019, 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 that a significant part of 
the juice is exported frozen. This issue is even more worrisome to small farmers which had already 
used chlorpyrifos early in their production process.  
2.247.   The representative of Guatemala  provided the following statement. Guatemala wishes to 
reiterate the importance of the European Union granting transition perio ds that closely follow the 
stages of crop production, in particular for crops grown in tropical countries . The productive sectors 
require more time to adapt and, in particular, find alternative substances, which in some cases 
means having to wait for suita ble production cycles to commence application and testing.  We are 
concerned that our ideas for discussions on finding solutions have not been heard and accepted . The 
trade concern regarding this issue focuses on safeguarding agricultural producers and expo rters 
exporting to the European Union, who will be affected by the European Union's change in conditions.  
We would be grateful if the European Union could : (i) establish genuine dialogue to discuss this 
issue; (ii) extend the transition period, with a view  to ensuring that trade is not obstructed any more 
than is necessary and giving time for tropical developing countries to adapt ; and (iii) provide 
clarification on how our comments on this process in the WTO are taken into account within the 
regulations.  
2.248.   The representative of Uruguay  provided the following statement. Our delegation welcomes 
the information provided by the European Union at the Committee's previous meetings, including in 
May of this year, at which time it indicated, inter alia,  that the effe ctive application of the reduced 
maximum residue levels (MRLs) is usually deferred by six months following the entry into force of 
such changes . However , in view of harvesting periods , the stages  at which plant protection products 
are applied, and the time  required to develop and register  alternative substances, in practice, the 
transition al periods granted by the European Union in the provisions amending MRLs for active 
substances do not provide  enough time to make the necessary adjustments to production a nd ensure 
that agricultural products , especially processed or frozen products,  comply with the new , lower  MRLs. 
Uruguay once again calls on the European Union to adopt regulatory decisions based on 
internationally accepted standards or to provide conclusiv e scientific evidence when it is strictly 
necessary to depart from these standards in order to meet its legitimate objectives, as provided for 
in the relevant WTO Agreements . Even in cases where the European Union decides, based on a full 
risk assessment , 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 al periods that are usually 
granted to make the relevant adjustments . 
2.249.   The representative of Ecuador  provided the following statement. Ecuador shares the 
concerns raised by Colombia, Costa Rica, Indonesia and the United States. We echo our previous 
statements on this specific trade concern. Ecuador once again reiterates its concern regarding the 
transiti onal periods granted by the EU for implementing its measures relating to the non -renewal of 
the use of substances and the reduction of MRLs. These periods fail to provide sufficient time for 
producers to adapt so as to prevent their access to the European market from being unnecessarily 
affected. We therefore urge the European Union to provide a period of at least 36 months, which is 
the time needed to develop a new phytosanitary pest control product. Ecuadorian farmers are, even 
against the backdrop of COV ID-19, making every effort to comply with the EU's requirements. 
However, it is impossible to do so in such a short period of time. A period of at least 36 months 
would be more appropriate for making the necessary adjustments in production and would enable  
producers to ensure compliance with the conditions laid down in the European regulations.  
2.250.   The representative of El Salvador  provided the following statement. El Salvador shares the 
views expressed by other delegations regarding the various European Union draft technical 
regulations on maximum residue levels. We urge the  EU to ensure that these are based on technical 
evidence and do not result in unjustified restrictions on trade.  Furthermore we would like to refer to 
the communication circulated in G/TBT/GEN/296  and its revisions, by C osta Rica, Guatemala, the 
Dominican Republic, Colombia, Argentina, Panama, Ecuador, Paraguay, Peru, Nicaragua, Honduras, 
El Salvador and others, in which the EU is requested to suspend for 12 months the review processes 
of MRLs as well as the entry into fo rce of all regulations in this area planned for 2020.  G/TBT/M/82  
 
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  2.251.   The representative  of Panama  provided the following statement. Like other delegations, 
Panama still has concerns regarding the potential EU regulations. These concerns have been 
expressed at previous me etings. Therefore, in order to be brief, and given that we have an extensive 
list of specific trade concerns,  I wish to refer to previous statements we have made on the subject . 
2.252.   The representative of Paraguay  provided the following statement. Paraguay refe rs to its 
statement under European Union - Hazard -based approach to plant protection products and setting 
of import tolerances (IMS ID 393 ), para. 2.215.    
2.253.   The representative of Chile provided the following statement. The delegation of Chile echoes 
the trade concern raised by the United States and supported by Costa Rica, Colombia, Indonesia, 
Brazil and the other delegations that took the floor before m e concerning the new maximum residue 
levels for various agricultural products set out by the European Union.  
2.254.   The representative of Canada  provided the following statement. Canada would like to 
reiterate its concern with the EU's transition periods for maxi mum residue limits. 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 acknowledge 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 must consider transition periods for MRLs taking into 
account the need for exporters to adapt to new requirements, as it has d one for its domestic 
producers.  
2.255.   In response, the representative of the European Union  provided the following statement. As 
clarified in previous TBT Committees, as a matter of principle, the EU considers that concerns on the 
setting of MRLs for pesticides – and any details regarding their implementation – should be an issue 
for discussion at the SPS Committee, rather than at the TBT Committee. Further to requests by 
some Members, and in the interest of transparency, the EU decided to notify all draft measur es on 
pesticide active substances that are relevant for the TBT Committee additionally also to the SPS 
Committee. In practice, future draft acts on the non -approval or restriction of approval of an active 
substance will be notified to both Committees. Howe ver, in the interest of efficient proceedings in 
both Committees and in line with the respective Agreements, the EU considers 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. The EU 
provided detailed information to Members as regards possible transitional periods when MRLs are 
lowered at the previous TBT Committee meeting last May.  
2.1.3.18   European Union - chlorothalonil (pesticide active substance), G/TBT/N/EU/625 , 
G/SPS/N/EU/394  (IMS ID 57957) 
2.256.   The representative of Costa Rica  provided the following statement. Costa Rica fully supports 
the comments made by Colombia and reiterates its concern regarding the measure notified by the 
European Union i n document G/TBT/N/EU/625  relating to the non -renewal of the approval of the 
active substance chlorothalonil. Costa Rica has repeatedly raised its concern over the lack of 
conclusive scientific evidence and the application of a precautionary approach in the processes to 
renew the mar keting permits, which then affect the establishment of MRLs. This is the case for 
chlorothalonil, with the Regulation relating to this substance entering into effect in May 2020 despite 
the many concerns raised in various WTO bodies at both the bilateral a nd regional level, at an 
extremely difficult time for tropical agricultural exporting countries such as Costa Rica, which 
continue to feel the adverse effects of the pandemic. In this respect, we support the call made by 
Costa Rica, Colombia and 37 other W TO Members in document G/TBT/GEN/296/Rev.3  for the EU to 
temporarily suspend all review processes of market approvals for plant protection substances, as 
well as the entry into force of regulations in this area planned for 2020, including the non -renewal 
of the active subst ance chlorothalonil.  
2.257.   The representative of Indonesia  provided the following statement. Indonesia shares the 
concern of Costa Rica, Colombia, Brazil, Guatemala, El Salvador and Ecuador regarding EU regulation 
on chlorothalonil . Indonesia has great interest in this matter as we are exporting agriculture products 
such as fruits, onion, peanut, and chili to the EU region. In addition, in ensuring Maximum Residue 
Limits of chlorothalonil, Indonesia refers to the international standard of Codex MRLs for Pesticide s 
 
57 For previous statements follow the thread under IMS ID  579 (under dates raised and references) . G/TBT/M/82  
 
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  as reflected in Ministry of Agriculture Regulation No.55 of 2016 regarding Food Safety Supervision 
Against Importation of Plant -Originated Fresh Food. Indonesia is of the view that the EU's measure 
on chlorothalonil is more stringent than necessary and h as the potential to disrupt trade, specifically 
for developing countries which export horticulture and other agriculture products to the EU. In this 
regard, Indonesia would like to request the EU to use an internationally accepted risk assessment 
approach,  based on realistic appropriate data and scientific study as stated in Codex MRLs for 
Pesticides which permitted the use of this substance in various plant products. Indonesia would also 
like to remind the EU that Article 2.4 of the TBT Agreement requests Members to  use existing 
international standards, or the relevant parts of them, as a basis for their technical regulations. We 
are of the view that trade disruption could not be avoided if Members arbitrarily start to disregard 
any international standards in their technical regulations.  
2.258.   The representative of Colombia  provided the following statement. Colombia reiterate s its 
concern regarding the measure notified by the European Union in document G/TBT/N/EU/625  
relating to the non -renewal of the approval of the active substance chlorot halonil.  Despite the many 
comments and requests for a longer transition period to adapt production processes, which in the 
agricultural sector are particularly complex, this regulation  entered into force in M ay, without the EU 
taking into account the conce rns raised by various  members in this Organization and in other 
settings . This substance is key to pest control for a wide variety of crops, particularly bananas, as it 
is used for the control of Black Sigatoka, a fungus that devastates banana crops.  Beyond this 
particular case, the EU has been adopting  measures under which approval for the use or marketing 
of plant protection products is not being renewed , which has an impact on the exports of its trading 
partners . Subsequently added to these measures  was the reduction of the MRLs to the minimum 
detection level , further hindering sales of certain agricultural products . These measures have been 
taken without any sound scientific evidence and without any proof that they effectively constitute 
less trade -restrictive measures to ensure an appropriate level of protection for consumers.  
2.259.   In Colombia, the use of plant protection  substances  – such as chlorothalonil – is essential  in 
agricultural production for the protection of crops against pests and diseases, and for maintaining 
the quality and safety of products during storage, transport and distribution, before they reach 
consumers in the European market.  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 . We consider 
that the European Commission (DG SANTE) has wrongly interpreted these opinions and thus , as a 
precaution, has not renewed the marketing permits for the substances.  Contrary to the provisions 
of the WTO 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 i nsufficient 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.  
2.260.   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 af fect human 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  tropical countries such as Colombia. Moreover, the situation 
that has arisen as a result of  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 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 
reducing their ability  to analyse draft regulatory measures and adjust production methods  
accor dingly , creating additional burdens on  international trade  in food products , which is hampering 
worldwide economy recovery efforts, especially in developing countries.  In line with the statements 
made in document G/TBT/GEN/296/Rev.3 , signed by 39  Members, we request the EU to temporarily 
suspend review processes of market approvals for  plant protection substances, and the entry into 
force of regulations in th is area, planned for 2020 , including the non -renewal of the active substance 
chlorothaloni l. G/TBT/M/82  
 
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  2.261.   The representative of Brazil provided the following statement. Brazil supports STC 579 and 
refers to its previous statements on the matter. We respectfully differ from the EU's decision to base 
measures on a hazard -based approach, without an adequate risk analysis and with  no comp liance 
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. We st ress our systemic concern with the fact that 
some hazard -based analyses conducted by the EFSA led to the non -renewal of approvals of some 
substances and subsequently to the reduction of their MRLs. The Brazilian National Health Agency 
has set MRLs for chlo rothalonil applied to more than 30 crops. The case of chlorothalonil affects 
Brazil's exports of banana, coffee, citrus fruits, papaya, watermelon, among others.  
2.262.   The representative of Guatemala  provided the following statement. Guatemala shares the 
concern regarding the entry into force of this regulation last month, especially because we still have 
no information on scientific evidence of the damage to human health caused by consuming fruits 
and vegetables, particularly those produced in Latin America . This is why it is important to request 
a risk analysis.  Chlorothalonil is used in the production of bananas, snow peas, sugar snap peas, 
French beans and coffee . It is a compound used as a broad -spectrum and fast -acting contact 
fungicide.  No other molecule on the market is currently as effective for controlling the Ascochyta 
fungus, above all in vegetables . Guatemala's climatic conditions provide this fungus with the ideal 
environment to reproduce,  affecting crops and seriously harming Guatemalan producers and 
exporters and the economy.  Substances such as mancozeb, azoxystrobin, pyraclostrobin, sulphur 
and difenoconazole can be used to substitute chlorothalonil . The registration of four of these 
alternative substances was not renewed for marketing in the European Union, and, as a result, 
maximum residue levels have been reduced to almost zero tolerance, leaving Guatemalan 
agricultural production with no options that can effectively combat diseases of  fungal origin.  
2.263.   Guatemala is geographically located in the tropics, where, unlike Europe, there are only two 
seasons, one rainy and one dry . This provides an ideal climate for pests and diseases to spread 
throughout the year and stimulates the growth of fu ngi, which can damage crops . The country is 
one of the world's leading producers of non -traditional vegetables and produced 70  million pounds 
of peas and 65  million pounds of green beans in 2019, making it one of the main exporters of these 
crops to the Eu ropean Union.  In Guatemala, the dynamics and growth of the sector have helped 
improve the quality of life of more than 60,000 families in some 200 rural communities that make 
up the sector's production base, generating around 20,000 jobs.  Guatemala's banan a exports 
accounted for 30 % of 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 . Banana 
production has directly and indirectly created over 280,0 00 jobs, and any changes to the production 
cycle resulting from an increase in disease due to a lack of alternative substances would affect over 
1,120,000 Guatemalans (Independent Banana Producers' Association, APIB, 2019).  
2.264.   We would therefore be grateful if the European Union would consider the particular 
circumstances of tropical countries when implementing the measures, until it has conclusive studies 
and has aligned itself with the provisions of the Codex . Accordingly, we request it to:  (a) consider 
the risk assessment approach and scientific evidence;  (b) set maximum residue levels (MRLs) that 
also correspond to the reality of tropical countries . These countries cannot be expected to have the 
same climatic conditions as European countries ; this is just not feasible . We therefore request that 
the MRLs for chlorothalonil be reviewed, taking into account that no chemical substance on the 
market can replace chlorothalonil and effectively control the Ascochyta fungus ; and (c) provide 
scientifically -based information showing that vegetables and fruit exported from Guatemala or third 
countries are harmful to the health of European consumers.  
2.265.   The representative of El Salvador  provided the following statement. Our delegation is 
concerned about the negativ e impact that this measure will have on exports of Salvadorian 
agricultural products and those of many developing countries to the European market.  
2.266.   The representative of Ecuador  provided the following statement. Ecuador wishes to reiterate 
its concern in r elation to notification G/TBT/N/EU/625  on the non -renewal of the use of the active 
substance chlorothalonil and document SANTE/10186/2018 Rev 1, through which the EU confirms 
the non -renewal of the use of the substance. Chlorothalonil is the main tool for controlling Black 
Sigatoka i n bananas due to its effectiveness, low cost and multisite mode of action, meaning that 
the risk of resistance is low. It is available in a wide range of products, through many suppliers, and 
is widely available in the country. Our concern stems from the f act that the non -renewal of the use G/TBT/M/82  
 
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  of chlorothalonil has resulted in the notification of document G/SPS/N/EU/394  on 15 June 2020 
concerning the draft Regulation on the existing MRLs for carbon tetrachloride, chlorothalonil, 
chlorpropham, dimethoate, ethoprophos, fenamidone, methioca rb, omethoate, propiconazole and 
pymetrozine. This proposes reducing the MRL for chlorothalonil in bananas from 15 ppm to 0.01 
ppm. Changing the MRL to the default level will affect our country's banana production.  
2.267.   Ecuador is a major banana -producing count ry, meaning that any negative impact on this 
sector will have significant repercussions for social development and especially for the economy of 
small, medium and large producers in the country. No substitute or similar phytosanitary products 
with the same  environmental or toxicological profile are available, since similar questions have been 
raised about the environmental and health effects of the alternatives to chlorothalonil (mancozeb, 
metiram, folpet, propineb). The productive banana sector provides jo bs for 2.5 million people. Every 
year, 300 million boxes of bananas leave Ecuador to be consumed around the world. These exports 
generate 2.1 billion in revenue for the country, accounting for 2% of GDP and 35% of agricultural 
GDP. Farms manage the use of agrochemicals in banana crops very well and maintain a culture of 
prevention in their operations and on the farm itself. Ecuador is requesting that, before a final 
decision is taken on implementing this measure and modifying MRLs, the European Commission 
consider all existing data, with due regard for consumer health and the potential effects on the food 
producing sector. Ecuador urges the EU to take into consideration the existing scientific information 
from international specialized agencies recognized by  the WTO, such as the Codex Alimentarius, 
which has relevant on this substance and establishes an MRL of 15 ppm specifically for bananas.  
2.268.   The representative of Paraguay  provided the following statement. Paraguay refers to its 
statement under European Union  - Hazard -based approach to plant protection products and setting 
of import tolerances (IMS ID 393 ), para. 2.215.    
2.269.   In response, the representative of the European Union  provided the following statement. As 
explained at previous TBT Committee meetings, the EU proposed not to renew the approval of 
chlorothalonil through Implementing Regulation (EU) No 2019/67758, adopted  on 29 April 2019. The 
draft Regulation was notified via the TBT procedure. Chlorothalonil was evaluated in accordance with 
Regulation (EC) No 1107/2009 on the placing of plant protection products on the market.59 The 
conclusion60 by the EFSA on this subst ance, following assessment by the "rapporteur " member State 
and an extensive peer review process, was published in January 2018. During the peer review 
process, the approval criteria provided for in Article 4 of the Regulation were not satisfied with 
respe ct to one or more representative uses of at least one plant protection product. Following the 
non-approval decision, the EU prepared a draft Regulation lowering the MRLs for chlorothalonil, 
which was notified to the WTO/SPS Committee ( G/SPS/N/EU/394 ). In view of the concerns identifi ed 
by EFSA, the EU intends to lower all MRLs for chlorothalonil at the relevant limits of quantification. 
The new values will apply as of August 2021 with no further transitional measures for products that 
were produced before the Regulation becomes applic able. Import tolerance requests remain possible 
and will be assessed on a case -by-case basis by the "rapporteur " member State and the EFSA. Such 
requests would have to be supported by substantial new data addressing the concerns.  
2.1.3.19   European Union - Medical D evice 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 59461) 
2.270.   The representative of Japan  provided the following statement. Japan would like to express 
its support for the development of medical device regulations that enhances the  quality and safety 
of medical devices in the EU. Japan additionally welcomes that the EU postponed the date of 
application of MDR by one year in response to the COVID -19 crisis. However, Japan would like to 
request the following points in order for manufa cturers exporting medical devices to Europe to obtain 
MDR certification by this application date. First, Japan would like to ask the EU to ensure that Notified 
Bodies (NBs) have sufficient capacity to issue certifications in a timely manner, including 
comm encement of evaluation by NB branch offices in Japan. Second, Japan requests that the EU 
regularly update "the on -going Medical Device Coordination Group (MDCG) guidance development 
 
58 OJ L 114, 30.4.2019, p. 15.  
59 http://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107   
60 EFSA 2018  Conclusion on the peer review of the pesticide risk assessm ent of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126,  http://www.efsa.europa.eu/en/efsajournal/pub/5126   
61 For previous statements follow the thread under IMS ID  594 (under dates raised and references) . G/TBT/M/82  
 
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  plan", since the publication dates for some MDCG guidance documents have n ot been determined, 
and also ask the EU to issue all MDCG guidance documents, which are necessary to comply with 
MDR, as soon as possible. Especially, guidance documents categorized as "Post-Market Surveillance 
and Vigilance (PMSV) ", "New Technology ", "EUDAMED " and "Unique Device Identifier (UDI) " are 
essential information for manufacturers.  
2.271.   The representative of the United States  provided the following statement. Thank you for 
your detailed update on the status of MDR and IVDR implementation during our bil ateral meeting 
last week. The United 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.  The one -year delay in implementation of the MDR 
provided some necessary relief. However, several issues remain regarding implementation of both 
the MDR and IVDR, and US industry remains concerned about its continued access to the EU's USD 
125 billion medi cal device market, USD 20 billion of which is supplied by US products. Given 
pandemic -related travel restrictions are making in -person audits difficult we urge additional 
consideration be given to allow virtual audits for both the MDR and IVDR. We are conc erned that the 
lack of audits will become a serious bottleneck. While we note that 17 NBs have been approved to 
assess conformity to the MDR, it is still significantly less than the number of Notified Bodies that 
were approved under the Medical Device Dire ctive (MDD). We ask for continued attention to the 
approval process to ensure Notified Body applications continue to move through the review process. 
We also note that there are currently only four NBs approved to assess conformity to the IVDR. If 
practica l solutions cannot be found to address these looming bottlenecks, we recommend serious 
consideration also be given to a significant extension in implementation of MDR and IVDR.  
2.272.   We are also concerned about the status of standards that companies can use to d emonstrate 
compliance with the essential requirements. We understand that many of the standards in the 
Commission's standardization mandate are not based on the latest international standard. A 
presumption of conformity is important to support market acces s in practical terms. We note that in 
preparation of the implementation of MDR, the Commission selected the Classificazione nazionale e 
internazionali (CND), a UDI system that is not harmonized with the well -established UDI system that 
utilizes the Global Medical Device Nomenclature (GMDN). GMDN was developed with the support of 
the International Organization Standardization and the International Medical Device Regulators 
Forum, and is widely adopted by the medical device industry and is used by over 70 nat ional medical 
device regulators to support their activity. We are concerned about the EU's selection of CND, 
because this selection will undermine the interoperability of the two UDI systems for tracking and 
reporting purposes, and will pose several signif icant obstacles to the medical device and healthcare 
community. Furthermore, the Commission has not made any progress on mapping CND to GMDN 
and has not addressed interoperability concerns. An additional consequence of the Commission's 
adoption of CND is t hat it could encourage other regulators and entities, like the World Health 
Organization, to adopt CND, creating duplicative requirements for the medical device industry.  
2.273.   The representative of China  provided the following statement. I would not like to rep eat 
what we have said at a previous meeting. Here I would like to refer to our statement on IVDR in the 
May TBT Committee meeting62 and China thanks EU for their detailed replies via bilateral channel 
and we appreciate that very much but here I would like to highlight one point regarding the transition 
deadline of IVDR because of COVID -19 epidemic impact on the implementation of IVDR.  We would 
like the EU to consider postponing the deadline of transition period of IVDR from May 2022 to May 
2024.  
2.274.   The representative of the Republic of Korea  provided the following statement. Korea supports 
EU's efforts to enhance the safety and quality of  medical devices in the EU market through the 
comprehensive revision of the regulation. In particular, we thank the EU for postponing the 
implementation of the MDR for a year to allow the Members , health institutions and economic 
operators to focus on resp onding to the COVID -19 pandemic. Korea also appreciates that the EU 
has significantly expanded the number of NBs from 12 to 21 as of September 2020. Nevertheless, 
we would like to highlight the challenges faced by the Korean industry in entering the EU mar ket 
due to the lack of information needed to comply with the MDR and the IVDR. Given this concern, we 
request the EU to swiftly issue the MDCG guidance and also update other regulatory information and 
guidance documents to help the industry prepare for the  implementation of the new regulation. Also, 
 
62 G/TBT/M/81 , paras. 1.465 -1.467.  G/TBT/M/82  
 
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  we were informed that a total of 52 applications are pending for designation as NBs. We anticipate 
that the EU will designate a sufficient number of NBs for CE certification as soon as practicable.  
2.275.   The represent ative of Canada  provided the following statement. Canada again wishes to 
echo the points raised by other Members regarding the implementation of this measure, which 
affects an important export market for Canadian medical device manufacturers. We remain 
concerned that the number of NBs still appears to be insufficient to carry out the certification and 
approval activities provided for in the regulations. We are also worried that the creation of a 
European Medical Device Nomenclature System under the new EU M DR would be in conflict with the 
existing global device nomenclature system (GMDN) that was created by regulators for regulators 
and has been implemented in various regulatory jurisdictions. This new system being created in 
Europe is considered by industry  to be a technical barrier to trade as yet another nomenclature 
system is being introduced. Will this be reconsidered or will there be an exercise of mapping the 
new European codes to the current GMDN codes?  
2.276.   The representative of Singapore  provided the fol lowing statement. Singapore supports the 
EU's objective of ensuring the enhanced safety and performance of medical devices. We appreciate 
the European Commission's postponement of the date of application of the MDR till 26 May 2021 to 
allow relevant stakeh olders to prioritize responding to the on -going COVID -19 pandemic. However, 
Singapore would like to register our concerns regarding the insufficient number of designated NBs 
under the MDR. We understand that as of 27 October 2020, only 17 NBs have been des ignated 
under the MDR. We are concerned that this could lead to backlogs and bottlenecks in the certification 
process for medical devices. Singapore notes the grace mechanism that has been put in place to 
smoothen the MDR's transition period, and the EU's consideration of contingencies in response to 
this issue. We look forward to further developments that will facilitate certification under the MDR 
and allow for continued access to the EU's medical device market.  
2.277.   In response, the representative of the European Union  provided the following statement. 
The new legislation on medical devices was adopted by the Council and the European 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 devices 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 was postponed until 26 
May 2021. The IVDR's63 corresponding date of application remains the same (May 2022). The 
Commission continues to monitor the impact of th e COVID -19 crisis with regard to this application 
date. The Commission and member States are continuing the work on implementing acts and 
guidelines under the current circumstances. To date, there have been 60 published guidance 
documents including several  key guidances on clinical requirements. In addition, the date for the 
launch of expert panels, as well as the registration module of the EUDAMED database, have been 
adapted to the new application date and will be in place during this quarter. The other pa rts of the 
EUDAMED database will be made gradually available. The legislation provides, in the meantime, for 
alternatives to the EUDAMED use.  
2.278.   To date, there have been 21 designations of NBs under the two new regulations, 17 under 
the MDR and four under the  IVDR. Additional designations will follow in the next few weeks. NBs 
designated under the MDR reportedly hold a significant share of the market. The Commission is also 
expecting a significant increase in the course of this year. Additionally, the grace me chanism to 
smoothen the transition will remain in place. As a final resort (in duly justified cases and in the 
interest of public health or patient health or safety), national competent authorities may authorize 
within their territory the placing on the ma rket 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.  
 
63 Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 on in -vitro 
diagnostic medical devices and  repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 
5.5.2017, p. 176).  
 G/TBT/M/82  
 
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  2.1.3.20   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA, G/TBT/N/PER/97 , 
G/TBT/N/PER/97/Add.1 , G/TBT/N/PER/97/Add.2  (IMS ID 61864) 
2.279.   The representative of Costa Rica  provided the following statement.  Costa Rica wishes to 
thank Peru for keeping us informed of the progress of the process to implement the draft Regulation 
established under Supreme Decree No.  015-2019-SA, which amends the Manual of Advertising 
Warnings approved  by Supreme Decree No.  012-2018-SA. As we have mentioned, under the 
proposed amendment to the Manual of Advertising Warnings, the use of stickers or adhesive labels 
to meet the Manual's labelling requirements will no longer be permitted in Peru as of June  2020. 
Peru recently informed us that the entry into force of this Regulation had been postponed until 30 
June 2021. Although this postponement offers some respite for our exporters, we wish to 
nonetheless reiterate our concern and respectfully request that  the Peruvian authorities consider 
permitting the use of adhesive labels on a reciprocal basis, given that these labels may be used on 
Peruvian food products to be marketed in Central America. The food industry has informed us of the 
negative repercussions  on trade that a potential discontinuation of the use of adhesive labels would 
entail. 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 informatio n purposes achieved by 
permanent labels. At the CODEX 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 guarantee d that they will not become separated from the container, 
taking into account cases where the language on the original label is not acceptable to the consumer 
for whom it is intended.  
2.280.   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 Costa Rican market are able to comply with domestic labelling requirements through the use 
of supplementary adhesive labels, instead of having to affix permanent labels in the countr y of 
origin, exclusively for the Costa Rican market. This undoubtedly fosters trade and is proportionate 
to the level of protection sought. We therefore ask for reciprocity of treatment. Moreover, we note 
that other Peruvian instruments, such as Supreme De cree 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 objecti ves. The fact that Peruvian legislation, in other instruments, permits the use of an 
adhesive 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 ac cordance with the obligations 
regarding technical barriers to trade established in the relevant World Trade Organization Agreement 
and in the existing Agreement between our countries.  
2.281.   With regard to the commitments made by Peru under the Agreement on Techn ical 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 Agreem ent. We are also of the view that, in light of the 
foregoing, the measure in question may be incompatible 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 i t 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 p ost-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. 
2.282.   The representative of the European Union  provided the following statement. The EU would  
like to thank Peru for extending by one year, until 30 Jun e 2021, the possibility to use stickers for 
compliance with labelling requirements for processed foods (Resolución Ministerial N°379 -2020-
 
64 For previous statements follow the thread under IMS ID  618 (under dates raised and references) . G/TBT/M/82  
 
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  Minsa). While this extension is appreciated, the EU would like to ask Peru to provide for a permanent 
possibility to u se stickers. We are committed to working with Peru bilaterally on this issue.  
2.283.   The representative of Brazil  provided the following statement. Brazil shares Peru's endeavour 
to ensure the highest health standards through technical regulations that help bette r inform 
consumers. Brazil regrets having to once again manifest its concerns regarding 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). As stated by other delegations in previous TBT meetings, the use of adhesive labels is 
a widespread practice internationally, and it does not affect the provision of reliable information to 
consumers. Codex standard CODEX -STAN 1 -1985 for pre -packaged goods, Articles 8.1.1 and 8.2.1, 
explicitly allows 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 i t is intended. Since the Peruvian regulation was first brought to our attention, we 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 for safe affixation 
of labels. Brazil would be willing to share with Peru its regulatory experience related to such labelling 
requirements. In our bilateral meetings, Peru failed to provide a time frame for possible amendments 
to the reg ulation, which creates greater uncertainty for our private sector to take on informed market 
decisions. Brazil would like to respectfully ask Peru to permanently align its labelling requirements 
with current international standards established under the Co dex and withdraw the prohibition of 
adhesive labelling for products under the scope of the Manual of Advertising Warnings. We 
acknowledge that, according to Decreto Supremo Nº 021 -2020-SA, the entry into force of the 
prohibition on adhesive labels was dela yed until 30 June 2021. Brazil considers such postponement 
a provisional solution and will continue to raise this STC until Peru permanently removes its 
burdensome requirements for food labelling.  
2.284.   The representative of Colombia  provided the following state ment. First of all, Colombia 
wishes to thank the delegation of Peru for its willingness to engage in dialogue and f or the various 
discussion forums open to our country to voice its concerns . However, we reiterate our concern 
regarding the Manual o f Adverti sing Warnings prepared in accordance with  the implementing 
regulations to Law  No. 30021 on the promotion of healthy eating among children and adolescents, 
which was issued through Supreme Decree No. 021-2020-MINSA of 12 June 2020 and notified in 
document G/TBT/N/PER/97/Add.2 . In accordance with the above -mentioned regulations, the 
deadline was extended to  30 June 2021 for the use of adhesive advertising warning labels that was 
provided for in paragraph 8.3 of section  8 of Supreme Decree No. 012-2018-SA, the  Supreme 
Decree approving the Manual o f Advertising W arnings.  As a result,  from 1 July 2021 processed foods 
will no longer be able to enter the Peruvian market by using stickers to comply with labelling 
requirements . In this regard, Colombia consider s that allowing the use of stickers does not distort 
the purpose of Law No. 30021  on healthy eating , its implementing regulations (Supreme Decree 
No. 017-2017-SA) or the Manual of Advertising Warnings (Supreme Decree No. 012-2018-SA), as 
the warnings, whet her included on stickers or printed directly on the packaging of products, will 
continue to be clear, legible, prominent and comprehensible, as required by the regulations.  
Colombia therefore considers that this provision is 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/WTO ("TBT Agreement "), which 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 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 (…)".  
2.285.   A technical measure on labelling that is so specific to a particular country, which must be 
implemented in 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 importing 
companies in Peru and producers in countries such as Colombia, especially for enterprises whose 
current and projected sales volumes in Peru cannot justify the expense of making a "factory" labe l 
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 increa sed expense of developing special packaging 
for trade with a country that imposes an unnecessary barrier of this nature will be most affected.  
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 G/TBT/M/82  
 
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  Mandatory Information of CODEX -STAN 1-1985 (Revised in 2018), General Standard for the 
Labelling of Pre -packaged Foods . It also runs counter to Article  2.4 of the TBT Agreement, whic h 
refers to the preparation, adoption and application of technical regulations and reads:  "(…) 2.4 
Where technical 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 look into the feasibility of allowing the 
use of stickers with warning icons and messages on food packaging to avoid cre ating an unnecessary 
technical barrier to trade such as the one envisaged in the Supreme Decree.  
2.286.   The representative of Guatemala  provided the following statement. Article 2 of Supreme 
Decree No.  015-2019-SA amends paragraph 8 of the Manual of Advertising W arnings approved by 
Supreme Decree No.  012-2018-SA by establishing that all food and beverages must display 
advertising warnings, where appropriate, and that the use of stickers featuring advertising warnings 
is permitted for one year from the entry into f orce of the Manual . The food and beverages covered 
by the Manual's second deadline may use stickers displaying advertising warnings for a period of six 
months after the entry into force of the respective parameter . Micro and small enterprises are 
permitted  to use stickers featuring relevant advertising warnings until 31  March  2022. The measure 
was not notified to the TBT Committee.  Guatemala thanks Costa Rica, the European Union, Brazil 
and Colombia for including this item on the agenda of the present meeti ng and recognizes Peru's 
legitimate objective of protecting human health and providing consumer information.  Peru's 
notification in document G/TBT/N/PER/97 , and the addendum G/TBT/N/PER/97/Add.2  of 
29 June 2020, which extends, until 30  June 2021, the deadline for the use of adhesive advertising 
warning labels that was provided for in the Supreme Decree approving the Manual of Advertising 
Warnings (Manual on Health Warnings) – Supreme Decree No.  021-2020-MINSA, imply that as of 
that date, pre -packaged food must be labelled, in accordance with the regu lations' requirements, in 
the country of origin.  
2.287.   Section 8.2 of Codex Standard CXS  1-1985, General Standard for the Labelling of 
Prepackaged  Foods, as revised in 2018, states that 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 . We believe that the measure in question is  more restrictive than 
necessary, since the use of adhesive labels is widely recognized internationally, as such labels fulfil 
the same public health protection and consumer information purposes as permanent labels, including 
when affixed in the country fr om which the products are imported.  We therefore insist that Codex 
provisions be taken into consideration, in particular the General  Standard for the Labelling of 
Prepackaged Foods, which allows supplementary labels to be used, as other trading partners ha ve 
done, thereby facilitating trade . This is particularly relevant to regulations like the one in question, 
which are becoming increasingly disharmonized.  Guatemala reiterates its concern over the lack of 
harmonization of front -of-package labelling worldwi de and of associated nutrient profiles . For small 
and medium -sized enterprises trying to internationalize their operations, these are complex 
measures that restrict trade.  
2.288.   The representative of Chile provided the following statement. Chile echoes what vari ous 
countries have said, and I will not repeat what has been about the details of the regulation. Firstly, 
we thank Peru for extending the period granted, but urge it to make the use of stickers labelled with 
"High in" on foodstuffs, where required, feasib le on a permanent basis. Chile has experience in this 
area. When implementing Chilean Law No. 20.606 on front -of-pack nutritional labelling, it permitted 
the use of adhesive stickers on a permanent basis, thereby complying with the legitimate objective 
pursued under the public policy, without creating an unnecessary additional requirement to achieve 
this. In view of the above, Peru is invited to reconsider accepting the use of stickers on a permanent 
basis, and not just until mid -2021.  
2.289.   In response, the repr esentative of Peru provided the following statement. The delegation of 
Peru would like to begin by thanking the delegations of  Costa Rica, the European Union, Brazil, 
Colombia,  Guatemala and Chile for their statements and comments, in particular to Brazil and Chile 
for sharing their experiences on this issue . 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 its 
most vulnerable groups, such as chil dren and adolescents, in accordance with its international trade 
commitments in this domain . As a result , and in light of the concerns raised by Members and trading G/TBT/M/82  
 
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  partners within this Organization , the Peruvian authorities have been conducting a comprehe nsive 
reassessment of the information mechanisms most suitable for achieving these objectives.  
2.290.   In order to continue these assessments, Peru, by means of Supreme Decree No.  021-2020-
SA, has extended the period during which the use of adhesive advertising wa rning labels, provided 
for in paragraph 8.3 of section 8 of Supreme Decree No. 012-2018-SA approving the Manual of 
Advertising Warnings under Law No.  30021 , is permitted until 30 June 2021 . As we have stated on 
previous occasions, Peru is seeking to ensure  that the information regulated by the Manual of 
Advertising Warnings reaches consumers clearly and effectively and cannot be unduly removed , so 
that they can make informed choices.  Lastly, we would like to emphasize once again that Peru wishes 
to honour i ts WTO commitments and therefore reaffirms its commitment to not preparing, adopting 
or applying technical regulations that may create unnecessary barriers to international trade, as 
established in the Agreement on T BT. 
2.1.3.21   European Union - Non-renewal of the approval of the active substance 
mancozeb, G/TBT/N/EU/712 , G/SPS/N/EU/384  (IMS ID 62765) 
2.291.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concern raised by the United States, Paraguay, Brazil, Australia, Indonesia 
and Colombia in relation to the draft Implementing Regulation no tified by the European Union, under 
which approval for the use of mancozeb would not be renewed. Costa Rica recognizes that Members 
have the 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 at a time when the pandemic continues to affect the econo mic recovery 
of the international markets. Mancozeb is essential for agricultural production in Costa Rica. The 
substance is currently used for more than 20 crops that are grown for export and domestic 
consumption, and is therefore vital for ensuring the s upply of food. It is also used to combat pests 
of economic importance, particularly in banana production.  
2.292.   Costa Rica is the world's second largest exporter of bananas, and the first country to have 
obtained a geographical indication for this product. Forei gn 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 and around 100,000 indirect jobs. The main 
destination for exports is the European Union, to which over 50% of the fruit produced in Costa Rica 
is sent. In Costa Rica, there are currently no authorized plant protection products that could be used 
as substitutes for, or are similar to, mancozeb. This illustrates the impact th at would be generated 
by the ban on the use of mancozeb and the subsequent reduction in MRLs for this substance in 
bananas. Despite our many reservations about the reasoning behind EU regulations, which will be 
raised next week in the SPS Committee, our ba nana sector continues to seek alternatives to 
mancozeb. However, time will be needed to complete the relevant tests and approval procedures 
for any alternatives found. Costa Rica therefore requests that the EU postpone the non -renewal 
process and subsequen t reduction of MRLs for mancozeb, so as to give the national sanitary and 
phytosanitary authorities a reasonable period of time to respond to the numerous challenges posed 
by the COVID -19 pandemic and find an alternative substance so that Costa Rican farme rs can 
continue to grow bananas and export the volumes required to meet the EU market demand.  
2.293.   The representative of the United States  provided the following statement. The United States 
notes that the EU has not yet finalized its April 2020 Draft Commissio n Implementing Regulation 
concerning the non -renewal of the approval of mancozeb, however, at the October 23 meeting of 
the Standing Committee on Plants, Animals, Food and Feed, experts from the EU member States 
supported the Commission's proposal not to r enew the authorization of mancozeb . The United States 
is disappointed that the EU once again has ignored internationally accepted standards for assessing 
risk and is unnecessarily disrupting trade without demonstrating a benefit to protecting human 
health.  Can the EU fully explain the risk of non -fulfilment to justify its non -renewal of substances? 
In response to the interventions at the May TBT Committee meeting, the EU simply repeated its 
assertion that mancozeb meets the EU's hazard cut -off criteria for endocrine disruption and 
reprotoxicity  alongside a concern for non -dietary exposure. The EU neither explained the level of 
protection it seeks to obtain nor addressed the fact that many countries and Codex have also 
reviewed this substance and established safe protective MRLs. For example, the United States has 
 
65 For previous statements follow the thread under IMS ID  627 (under dates raised and references) . G/TBT/M/82  
 
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  completed a rigorous risk assessment and established MRLs for mancozeb following its registration 
renewal in 2005. The US EPA continues to re -evaluate mancozeb under its Registration Review 
process.  
2.294.   Codex has also established MRLs for mancozeb on many food crops based on risk assessment 
principles and review of good agricultural practices. These MRLs facilitate trade while protecting 
consumer health. The proposed non -renewal of approval of mancozeb pr ovides yet another example 
of the negative impact and great uncertainty resulting from the EU's hazard -based cut -off criteria 
for possible endocrine disruptors. The EU regularly suspends risk assessments of active ingredients 
following any indication that they might meet its hazard criteria, including the presence of data gaps. 
As an example, the EU did not finalize the consumer dietary risk assessment of mancozeb in its June 
2019 peer review. In August 2020, the EFSA published a reasoned opinion for reques ted 
modifications to MRLs for mancozeb for garlic, broccoli, cauliflower, and leeks. EFSA used the residue 
definitions and reference doses that existed in the EU for mancozeb at the time of the review and 
found the data sufficient to establish the requeste d increases to MRLs. However, instead of 
recommending MRLs it suggested that "further risk management considerations are required " 
because the 2019 risk assessment was never finalized. 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 for cotton, potatoes, corn, safflower, sorghum, 
peanuts, tomatoes, flax, and cereal grains. Producers of these crops require regulat ory certainty to 
make effective and responsible crop protection decisions. Routinely failing to complete risk 
assessments on critical plant protection technologies significantly increases economic risks to 
producers.  
2.295.   This draft regulation further highlight s our concerns with the EU's MRL transitional 
arrangements because it allows only a six -month grace period before the MRLs enter into force. 
Following the six -month period, the remaining time before enforcement of reduced MRLs is 
completely unknown. Even w hen MRLs are valid at the time crops are harvested, there is great 
concern that a more restrictive MRL may be in place before the final product reaches the EU. The 
United States exported more than USD 3.3 billion in fruits, vegetables, and tree nuts to the  EU in 
2019. The trade loss resulting from the removal of  a single MRL is difficult to measure. However, 
there is little doubt that the EU's unjustified removal of MRLs for critical crop protection tools 
unnecessarily increases the cost of food to consumer s and creates commercial uncertainty for 
growers and traders with little known benefit to human health and environmental safety. The United 
States asks how the EU is meeting its obligation to minimize negative trade effects. The United 
States asks again th e level of protection that the EU seeks to achieve with its non -renewals of 
approval of active substances, especially when these decisions feed into MRL decisions made in the 
absence of a scientific assessment of risk? Given the broad acceptance globally o f MRLs for 
substances such as mancozeb, will the EU explain how it is making regulatory decisions that take 
into account necessary scientific evidence and minimize negative trade effects?  
2.296.   The representative of Paraguay  provided the following statement. Par aguay refers to its 
statement under European Union - Hazard -based approach to plant protection products and setting 
of import tolerances (IMS ID 393 ), para. 2.215.    
2.297.   The representative of Brazil  provided the following statement. Brazil would like to once again 
raise STC 627  regarding the non -renewal of the approval of the active substance mancozeb, 
according to notification G/TBT/N/EU/712 . As stated in our comments submitted to th e EU TBT Focal 
Point, 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. We have warned European delegates about the 
relevance we attach to this regulatory process in previous bilateral meetings and we tried to receive 
more information regarding the review process. However, the EU informed that before the 
notification publication no comments would be taken into consideration. We look forward to receiving 
the EU's response to our timely submitted comments on notification G/TBT/N/EU/712 . The 
availability of an alternative to mancozeb in the short to medium term is also limited by the fact that 
other substances of similar use have already been banned in the European market, such as 
chlorothalonil.  
2.298.   Mancozeb is an important tool for the managemen t of fungicide resistance to control soybean 
rust, one of the most devastating diseases for this crop. It is used as a crop protection additive, G/TBT/M/82  
 
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  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 trans ition periods that are 
adequate to the production cycle of the affected crops. The implementation of regulations with 
serious impacts on trade prior to a thorough risk analysis raises concerns about discrimination, 
transparency, and due scientific evaluati on. 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 are available, we would like to hear from the EU delegation if that information is accurate 
and up to date. Once again, Brazil respectfully asks the EU to respond to the following questions, 
which were not addressed in the European intervention of the last TBT meeting: (i) what are the 
most recent studies and assessments used for the re -evaluation 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 regulati on? 
2.299.   The representative of Australia  provided the following statement. Australia recognizes the 
EU's right to regulate the manufacture and use of plant protection products in agriculture to address 
risks unique to its settings. However, Australia is concern ed about the proposed non -renewal of 
mancozeb given the potential impact on MRLs and effects this may have on trade, including wine 
exports to the EU. Australia seeks clarification on the risks to consumers from mancozeb residues 
on produce, especially win e, and how these will be taken into consideration in the revision of MRLs. 
Australia notes that the EU has recently made several plant protection products non -renewal 
decisions and subsequent changes to relevant MRLs which are impacting Australia's trade w ith 
Europe. Australia also notes that its competent domestic authority (Australian Pesticides and 
Veterinary Medicines Authority) and Codex have determined MRLs for dithiocarbamates that ensure 
the continued protection of human, animal and environmental he alth while allowing trade to 
continue.  
2.300.   The representative of Indonesia  provided the following statement. Indonesia thanks Costa 
Rica, the United States, Paraguay, Brazil, Australia, Colombia and Guatemala for raising this issue 
and shares the same concern regarding EU regulation on Non -renewal of the approval of the active 
substance mancozeb. We place great interest on this issue given our agriculture exports to the EU 
region. In ensuring our standard, Indonesia is referring to the international standard of  Codex 
pesticide MRLs for mancozeb that is still allowed to be used in various plants such as fruits, onion, 
chili, pepper, pepper chili, and mango. This is reflected in Indonesia Ministry of Agriculture regulation 
No.55 of 2016 regarding Food Safety Super vision Against Importation of Plant -Originated Fresh 
Food. Indonesia reiterates its concern on the EU's Non -renewal of the approval of the active 
substance mancozeb. Indonesia is of the view that this measure is more stringent than necessary 
and has the po tential 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 restric tive than necessary. We note 
that the EU refers to the safety and health aspect of environmental whilst developing  the Draft 
Commission Implementing Regulation 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 amending 
the Annex to Commission Implementing Regulation (EU) No 540/2011.  
2.301.   However, Indonesia would like to em phasize that the internationally accepted standard 
provides a balance between safety and health with improving efficiency of production and facilitating 
the conduct of international trade as recognized by the TBT Agreement. Ensuring the use of 
recognized i nternational standards is also vital for developing countries in ensuring the enjoyment 
of transfer of technology as enshrined in the TBT Agreement. In this regard, we urge the EU to use 
a risk assessment approach that is internationally accepted based on  appropriate data and scientific 
study, particularly in accordance to Codex Pesticides MRLs, which permitted the use of this substance 
in plant products. Indonesia would also like to remind the EU that the Article 2.4 of the TBT 
Agreement requests Members t o use existing international standards, or the relevant parts of them, 
as a basis for their technical regulations. We are of the view that the trade disruption could not be 
avoided if Members arbitrarily start to disregard any international standards in th eir technical 
regulations.  G/TBT/M/82  
 
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  2.302.   The representative of Colombia  provided the following statement. Colombia reiterates  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 subst ance 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, which 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 MRLs to the minimum detection 
limit are being taken without any sound scientific evidence and without proof that such measures 
are the least trade -restrictive means of achieving an appropriate level of protection.  Mancozeb is a 
fungicide used in more than 70 fruit and vegetable crops across the world to control over 400 
phytopathogenic fungi that attack the crops . However, the main  use of mancozeb is to prevent the 
fungi from developing resistance to curative fungicides (by using it in combination with them), 
helping to ensure that these fungicides remain effective.  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 Sigatoka, 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  - FRAC ) due to its 
ability to adapt rapidly to climatic changes and, above all, its inherent capacity to develop resistance 
to various chemical groups of fungici des. 
2.303.   This fungus currently shows resistance to three different chemical groups of fungicides used, 
which is 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.  Banning mancozeb would leave 
banana -producing countries without any phytosanitary tools to control this disease, resulting in 
significant economic losses in  Latin American countries , which would have highly regrettable 
consequences for the environment and the economic sustainability of banana crops , with their 
respective social implications , bearing in mind that in Colombia, for example, over 35,000 people 
directly and some 120,000 people indirectly depend on the production of bananas for export to the 
EU for their livelihoods.  Such measures would be in disregard of Article 2.2 of the TBT Ag reement, 
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 effective than the method involving the use of the above -mentioned active substances . 
2.304.   As indicated in the comments submitted on EU regulations, there is insufficient scientific 
justification for changing regulations on active substances, and 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 information and conclusive scientific studies 
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, as 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.  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 basis, 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 correspondi ng levels of exposure for determining the safety 
thresholds for mancozeb.  
2.305.   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 count ries that may be affected 
by the implementation of the regulation, in order to avoid creating an unnecessary technical barrier 
to trade.  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 grea ter clarity regarding the time  frame 
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 reasonable 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 
situation that has arisen as a result of 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 G/TBT/M/82  
 
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  same token, key sectors such as food producer s, organizations and associations are having to make 
significant efforts to ensure biosecurity controls in the fruit and vegetable supply chain . This is 
reducing their ability to analyse draft regulatory measures and adjust production methods 
accordingly, creating additional burdens on international trade in food products, which is hampering 
worldwide economy recovery efforts, especially in developing countries.  In light of the arguments 
presented, Colombia requests the EU to renew the approval of mancozeb and maintain its maximum 
residue limits ( MRLs) as a risk management measure to guarantee the health of consumers in the 
EU and facilitate trade for its partners.  
2.306.   The representative of Guatemala  provided the following statement. Guatemala shares this 
concer n given the lack of information on scientific evidence of mancozeb's detrimental effects on 
human health . Moreover, the European Union (EU) has not presented any scientific evidence of the 
supposed danger and harmful nature of mancozeb in relation to the c onsumption of fruit and 
vegetables exported by third countries to the European market.  The EU has previously mentioned 
that it has identified potentially negative health effects allegedly caused by mancozeb . However, it 
has failed to provide the countries affected with information on the contamination of products that 
have been assessed.  We note the outcome of the meeting of the Standing Committee on Plants, 
Animals, Food and Feed (PAFF Committee) of 23  October this year . Despite the requests of various 
Member States to continue the discussion on exploring the possibility of renewal, the Commission 
decided to proceed with a vote on mancozeb, which resulted in a decision not to renew its approval . 
A grace period of six months has been established for sale and  distribution plus six subsequent 
months.  We understand that the EU Mancozeb Task Force will research alternative ways to keep this 
vital tool available with a view to breaking down European farmers' resistance . However, this type 
of measure not only affec ts European farmers who receive economic support from their 
governments ; it also significantly affects agricultural producers in countries that export to the 
European market, such as tropical developing countries . We note with concern that the European 
Union has not considered these factors in its assessment.  
2.307.   For the time being, mancozeb MRLs remain unchanged, but we are concerned that this latest 
decision will bring about the revision of those MRLs . The EU's practice since the non -renewal has 
been to revis e MRLs and, according to this new trend, they are always revised downwards, without 
taking into account the climatic conditions in tropical countries and the distances involved in shipping 
products to the European market.  Mancozeb is vital for controlling pests in the production of a 
number of strategic agricultural crops exported to the EU, including fruit (such as bananas and 
plantains) and vegetables . Guatemalan producers would therefore be affected.  Mancozeb, as a 
multi-site fungicide, attacks different  parts of the fungus and creates no resistance . Very few of the 
alternative fungicides available on the market have these multi -site properties.  In the specific case 
of plantains and bananas, mancozeb is essential given the absence of alternatives offering  the same 
level of effectiveness . Black Sigatoka, for instance, is caused by the fungus Mycosphaerella fijiensis , 
which invades and necrotizes the leaf tissue, causing leaf death . It is one of the diseases with the 
greatest economic impact on banana and pl antain crops worldwide, and in tropical regions can only 
be successfully controlled with mancozeb, which is why the ban on the use of mancozeb will have a 
social and economic impact on Guatemala.  
2.308.   Plantain and banana crops are a significant source of job cr eation and foreign exchange, and 
are also beneficial in terms of rural development and food security in rural communities . The crops 
provide over 280,000 direct and indirect jobs, thereby affecting more than 1,120,000 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 exchan ge generated 
by this crop . Such earnings have been on the increase since 2018, ranging from USD  800 million to 
USD 1 billion.  In light of the above, we request the EU to ensure that these measures do not affect 
mancozeb MRLs and to maintain its current lev els, so as to avoid affecting the production and exports 
of Guatemala and other Latin American countries.  In view of the economic and social impact that 
this type of measure will have on developing countries, we reiterate the request set out in documents 
G/SPS/GEN/1778  and G/TBT/GEN/296 , especially given the cur rent COVID -19 situation and the 
second wave of critical cases that now exceed the number recorded in Europe in February and March, 
while Latin American countries are still coming out of the first wave of the pandemic.  
2.309.   The representative of Argentina  provid ed the following statement. We maintain our general 
concern regarding the hazard -based approach used by the EU as regards regulating pesticides, 
without identification of risk, which is an unnecessary technical barrier to trade.  In the case of G/TBT/M/82  
 
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  mancozeb, th is is a broad -spectrum fungicide used for growing fruits, vegetables and field crops.  
Although Argentina shares the EU's concern over strengthening the protection of human health and 
the environment, we would once again like to underline the importance of complying with Articles  2.2 
and 2.4 of the TBT Agreement, which stipulate that "technical regulations shall not be more trade 
restrictive than necessary to fulfil a legitimate objective".  We are particularly concerned by the 
number of substances banned by the EU Commission, which have been increasing with each passing 
day. As indicated in documents G/SPS/GEN/1778/Rev.4  and G/TBT/GEN/296/Rev.4  (Request for the 
suspension of the processes and entry into force of reductions of MRLs for plant protection products), 
this situation may have seriou s consequences for various WTO Members, particularly developing 
countries, whose populations and economies are highly dependent on agricultural exports.  It is 
therefore crucial for the EU to use a risk assessment approach in the analysis of these regulator y 
changes and to have conclusive scientific studies to determine the various aspects that may affect 
human health and the environment.  
2.310.   The representative of Chile provided the following statement. The delegation of Chile echoes 
the trade concern raised aga inst the European Union for not renewing the authorization of the active 
substance mancozeb, a concern that was raised by Costa Rica, the United States, Brazil, Paraguay, 
Australia, Colombia and Indonesia, and supported by the delegations that took the flo or before me. 
The delegation of Chile will be following up on this topic.  
2.311.   The representative of Ecuador  provided the following statement. We echo their concerns, as 
well as those raised by other Members. Mancozeb is a fungicide used worldwide on many crops  
including bananas, cocoa, broccoli, pineapples, pitahayas, mangoes and cape gooseberries. This 
substance is crucial for the management of pests and resistance in agricultural production, since the 
tropical climate in countries such as ours means that the behavioural patterns of pests and diseases 
are very different to those in countries with four seasons. It is vital that studies assessing the renewal 
of active substances are based on scientific evidence and conclusive data rather than the 
precautionary pr inciple. Ecuador therefore urges the EU to take into consideration the relevant 
scientific information emanating from international specialized agencies recognized by the WTO, 
such as the Codex Alimentarius, which has relevant information on this substance . Ecuador requests 
the EU to renew the approval of mancozeb. In the absence of alternatives, the ban on the use of 
mancozeb would leave Black Sigatoka control and management programmes without any 
phytosanitary tools. This would have very unfortunate conse quences for the environment and the 
economic sustainability of banana crops, which, in turn, would lead to social consequences, given 
that this sector creates a significant number of jobs. Lastly, we echo the questions posed by Brazil 
to the EU concerning the re -evaluation of mancozeb, the timeliness of the notification of this draft 
Regulation, and what other less trade -restrictive alternatives were considered in the development 
of this draft Regulation.  
2.312.   In response, the representative of the European Unio n provided the following statement. As 
explained in the last TBT Committee meeting, 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 subst ance mancozeb, in accordance with Regulation (EC) No 1107/2009 on 
the placing of plant protection products on 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 m ember 
States of the European Union and the EFSA. EFSA concluded that mancozeb does not meet the 
approval criteria as outlined in Article 4 of Regulation (EC) No 1107/2009. The approval of mancozeb 
can therefore not be renewed. EU member States must withdra w existing authorizations for plant 
protection products containing 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 Regulation. Following non -approval and the expiry of all grace periods for stocks of 
products containing this substance, separate action will likely be taken on MRLs and a separate 
notification will be made in accordance with SPS procedures.  
2.1.3.22   Bangladesh - Hazardous Waste (E -waste) Management Rules, 2019, 
G/TBT/N/BGD/3 , G/TBT/N/BGD/3/Add.1  (IMS ID 62066) 
2.313.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation thanks the delega tion of Bangladesh for bilateral engagement on this issue. However, 
 
66 For previous statements follow the thread under IMS ID  620 (under dates raised and references) . G/TBT/M/82  
 
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  our concern with the inclusion of nickel into the list of hazardous wastes under the draft E -Waste 
Management Rules stands. In this regard Russia reiterates its statement made in May 2020.  We 
consider this measure to be more trade restrictive than necessary. If adopted in the notified version, 
E-Waste Management Rules will distort international trade in nickel and nickel -containing products 
as well as global value added chains . We kindly as k Bangladesh to postpone the date of entry into 
force of this draft legal act and reopen discussions on this issue with the WTO Members and other 
stakeholders. Additionally, we would welcome an update from Bangladesh on the current state of 
play in the dra fting of the measure.  
2.314.   The representative of the Republic of Korea  provided the following statement. Korea highly 
regards the efforts of the Bangladesh and competent authorities to introduce Hazardous Waste (E -
waste) management rules for protecting the envi ronment and managing recycling resources. 
Furthermore, Korean companies are committed to fully comply with the rules of Bangladesh . Korea 
sent an official letter to the Bangladesh Enquiry Point on 28 April 2020 on companies' difficulties 
related to the regulation; as far as we know, Bangladesh has been collecting additional opinions 
through the WTO TBT. Nevertheless, Korea still has the following difficulties regarding Bangladesh's 
E-waste Management Rules, and Korea would like to ask for a review of the  regulation and for further 
information. First, no specific enforcement date has been provided for these proposed rules . 
Although their entry into effect has been stipulated within 2020, compliance with these rules may 
be difficult if they suddenly enter i nto force without any prior notice. Therefore, Korea would like to 
ask Bangladesh to provide us an interval of more than six months between the publication of 
regulations and their entry into force, and we ask you to advise if there is any information rega rding 
the specific date of enforcement. Second, In Schedule -3 of the regulation, nine non -replaceable 
chemicals, such as Polyvinyl Chloride (PVC) and Liquid Crystals, etc. have been designated as 
harmful substances. Designation of these materials is not a common international case. Therefore, 
Korea would like to ask Bangladesh to provide scientific evidence for this matter and to consider the 
withdrawal of the designation of these materials. Third, the standards of content limits for some 
compound hazardous  substances included in Schedule -3 are ambiguous. Korea would like to request 
Bangladesh to provide us with clear information as to whether the standards of content limits are 
applied to each individual substance or the total amount of the hazardous substa nces.  
2.315.   The representative of Canada  provided the following statement. Canada welcomes this 
opportunity to continue discussions on G/TBT/N/BGD/3 , Hazardous Waste (E -Waste) Management 
Rules, 2019, which Bangladesh notified to WTO Members on 20 February 2020. Canada raised this 
STC at the May 2020 TBT Committee Meeting seeking further clarity on specific aspects of the 
Management Rules, notably regarding the method and rationale Bangladesh has followed to 
elaborate groupings in Schedule 3. This includes, for example, the rational for the br oad group of 
"Mineral Wool ", the joint entry for "Nickel and Cadmium/Cadmium oxide/ Cadmium Sulphide ", and 
the specifics behind the inclusion of a flame retardant substance like Tetrabromobisphenol -A. The 
full extent of Canada's questions and concerns can be found in its previous intervention ,67 as well as 
in its comments submitted to Bangladesh's Enquiry Point on 16 April 2020 and for which Canada 
looks forward to receiving an official reply from Bangladesh. At the previous Committee meeting, 
Bangladesh co nfirmed that its competent authorities were reviewing the concerns raised by WTO 
Members, and would revert once they had more detailed replies to share. Canada would like to know 
if Bangladesh is now in a position to share new  information and additional su pportive documentation 
on the Management Rules, including timelines for consultations on the full regulatory text. Canada 
encourages Bangladesh to ensure a high level of transparency on the Management Rules, including 
by notifying the full text of the new Management Rules as soon as possible and providing the 
minimum 60 -day period, so that all affected parties may assess the potential impacts of the measure 
and provide substantial comments for Bangladesh's consideration. This would support the shared 
endeav our of Members to ensure that unnecessary impacts on trade be avoided.  
2.316.   The representative of the European Union  provided the following statement. The European 
Union has concerns on the hazardous waste management rules. We sent written comments to 
Banglades h 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 
restricted by any existing international legislation and thu s 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.  
 
67 G/TBT/M/81 , item 1.2.1 . G/TBT/M/82  
 
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  2.317.   The representative of the United States  provided the following s tatement. The United States 
supports the other Members raising this STC, and we refer to our previous statements on this 
measure.  
2.318.   In response, the representative of Bangladesh  provided the following statement. Bangladesh 
thanks Canada, the European Union, the Republic of Korea and the Russian Federation for their 
interest in the proposed E -Waste Management Rule 2019 and the concerns raised, which are still 
being reviewed by our competent authorities in capital. Bangladesh also expresses willingness to 
engag e with Members bilaterally about their concerns. We will revert back once we have more 
detailed replies of specific concerns such as specific dates of enforcement, restriction of chemicals 
mentioned in Schedule -3, standard of contents in the same schedule , and others.  
2.1.3.23   Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011), G/TBT/N/RUS/2  (IMS ID 33268) 
2.319.   The representative of the European Union  provided the following statement. In 2012, the 
Russian Federation notified a draft technical regul ation on alcohol products safety. An updated 
version was adopted in December 2018 and supposed to enter into force on 9 January 2021. In light 
of transparency and considering the trade implications of this regulation, we would like to ask Russia 
to fulfil its obligations and notify the revised text to the TBT Committee. The technical regulation 
also contains provisions covered by the Agreement on TRIPS. The EU would like to invite Russia to 
also notify the regulation to the Council for TRIPS, as some of the se provisions, in particular 
impacting EU geographical indications, raise serious concerns for the EU. 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 technical regulation in some cases contain more stringent limits than 
those set in the recommendations of the International Organisation of Vine and Wine (OIV), which 
Russia is a member of. The application of these diverging requirements would represent a serious 
obstacle for the importation of these products.  
2.320.   The EU is concerned by the mandatory labelling requirements, which are not in line with 
international practice. 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? As already 
mentioned in a separate STC earlier, the articulation with the "Federal law  on wine making and wine 
growing in the Russian Federation" is problematic on several points. This has to be clarified. In view 
of these inconsistencies, the EU understands  that the Russian authorities have requested to postpone 
the entry into force of thi s measure (planned for January 2021) by one year, and grant a transitional 
period to further discuss the standards and explore whether business operators can progressively 
adapt them. Can the Russian authorities confirm this and inform when the final decis ion will be taken 
and formalised? The European Union would like to ask Russia to take these comments into 
consideration and to re -notify the new version of the measure, under the TBT agreement as well as 
under the TRIPS agreement.  
2.321.   The representative of Ukraine provided the following statement. Ukraine thanks the EU for 
keeping this issue on the agenda and echoes the concerns raised with regard to the draft TR on 
Alcohol Drink Safety. Ukraine continues to have strong concerns on the Russian Federation 
certification requirements for alcohol drinks and we would like to refer to our statements made in 
the course of the previous TBT Committee meetings for further detail. Today we would like to draw 
attention to the issue of the cost of conformity assessment proce dures for producers from WTO 
Members other than member states of the Eurasian Economic Union. In particular, this includes 
additional costs associated with the registration of legal entities on the territory of the Eurasian 
Economic Union or contracting wi th existing legal entities registered on the territory of the Union as 
per established requirements. As a result, the cost of required conformity assessment is higher for 
other WTO Members compared to the cost for manufacturers based in the Eurasian Econom ic Union. 
Ukraine is of the view that such a regime, if not amended, would amount to a violation of Article 5 
of the TBT Agreement. Ukraine would like to reiterate its request to the Russian Federation to provide 
a practical update on the draft TR on alcoh ol with the aim to remove unjustified technical barriers to 
trade and comply with the transparency requirements embodied in the TBT Agreement.  
 
68 For previous statements follow the thread under IMS ID  332 (under dates r aised and references) . G/TBT/M/82  
 
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  2.322.   In response, the representative of the Russian Federation  provided the following statement. 
The Technical Regulat ion of the Eurasian Economic Union on safety of alcohol products was adopted 
in December 2018 and is supposed to enter into force in January of 2021. As was rightly mentioned 
by our EU counterpart, the draft decision of the Eurasian Economic Commission Cou ncil delaying for 
one year the date of entry into force of the Technical Regulation has been prepared and is now in 
the process of approval. The draft Technical Regulation was notified in 2012 as per requirements of 
WTO transparency provisions. Currently, there are no plans to re -notify the adopted text of the 
Technical Regulation in the TBT Committee. Additionally, we fail to see grounds set out in Article 63 
of the TRIPS Agreement for notification of the Technical Regulation in the TRIPS Council. As for 
physical and chemical requirements, we note that in most cases 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. The core aim of such requirements is to provide a 
safe product to Russian consumers. Date of bottling and storage conditions labelling requirements 
are also not new requirements. They were introduced many years ago to avoid alcohol intoxication 
and fatal casualties among consumers. As stated previously, we confirm that the use of stickers is 
allowed as there is no prohibitive provision in the Technical Regulation.  
2.1.3.24   European Union - Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rul es for the application of Council Regulation (EC) No 
479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/44 , G/TBT/N/EU/264 , G/TBT/N/EU/264/Add.1 , G/TBT/N/EU/570 , 
G/TBT/N/EU/571  (IMS ID 34569) 
2.323.   The representative of the United States  provided the following statement. It is very 
disappointing that the United States must again raise its concerns with the EU 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 t raditional terms were still under consideration, but that it could not provide 
a precise timeline for approval. Why is the EU still unable to provide any estimate or tell us where 
in the process these applications are after over two years? As we indicated at the November 2019, 
February 2020, and May 2020 TBT Committee meetings, it would be helpful if the EU could provide 
some transparency about the status of other applications so that we can see how our applications 
compare. As requested during the February  and May 2020 TBT Committee meetings, please tell us 
the following: how many applications for traditional terms have been lodged over the last ten years; 
how many of those applications have been approved, rejected, or remain pending; what is the 
average ti me between application and a final decision; for pending applications, how long have they 
been waiting; and how many of the applications have come from member States.  
2.324.   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 aged " and certain bottle shapes, to wines with geographical indications. Now that 
the EU has adopted the regulations, the United Sta tes once again requests the EU to move 
expeditiously to approve our industry's applications so that we can remove 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 h ow the processing of these applications has changed, if at all, over the last year 
following the adoption of Implementing Regulation 2019/34? The United States asked for clarification 
on this point during the November 2019 and February and May 2020 TBT Com mittee meetings but 
did not receive clarification from the EU.  
2.325.   The representative of Brazil  provided the following statement. Brazil would like to support 
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.  
2.326.   The representative of Argentina  provided the following statement. Argentina reiterates the 
concerns expressed at previous meetings of this Committee regarding the d iscrimination suffered 
by national wines, which are prevented from using the traditional terms " Reserva " and " Gran 
Reserva " on their labels, even though our country completed the substantive procedure to approve 
 
69 For previous statements follow the thread under IMS ID  345 (under dates raised and references) . G/TBT/M/82  
 
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  such terms in March  2012 under EU law.  We on ce again urge the EU to activate all applications for 
the registration of traditional terms submitted by third countries such as Argentina, which have come 
to a standstill without any legal justification, thereby constituting a technical barrier to trade.  
2.327.   The representative of New Zealand  provided the following statement. New Zealand 
recognizes that Members have the right to protect their consumers from deceptive practices in line 
with their WTO obligations. New Zealand asks that the European Union takes in to 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 Europ ean Union.  
2.328.   In response, the representative 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 discussed in previous 
TBT Committees leading to the adoption of Commission Delegated Regulation (EU) 2019/33 and 
Commission Implementing Regulation (EU) 2019/34. The EU believes that its internal legislation 
offers a meaningful and tr ansparent system of protection to traditional terms used on wine products 
from the EU, as well as on products from third countries. The EU has demonstrated its ability to 
address specific Members' concerns in this area either via its internal legislation o r via bilateral 
agreements.  
2.1.3.25   India - Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IDN/44 , G/TBT/N/IDN/44/Add.1 , 
G/TBT/N/IDN/44/Add.2 , G/TBT/N/IDN/44/Add.3 , G/TBT/N/IDN/44/Add.4 , 
G/TBT/N/IDN/44/Add.5 , G/TBT/N/IDN/44/Add.6 , G/TBT/N/IDN/44/Add.7,  
G/TBT/N/IND/44/Add .8, G/TBT/N/IDN/47 , G/TBT/N/IDN/47/Add.1 , 
G/TB T/N/IDN/47/Add.1/Corr.1 , G/TBT/N/IDN/47/Add.2 , G/TBT/N/IDN/47/Add.3 , 
G/TBT/N/IDN/58  (IMS ID 36770) 
2.329.   The representative of the United States  provided the following statement. We appreciate 
India's Ministry of Electronics and Information Technology (MeitY) April 2020 notification to the TBT 
Committee of the Electronic s and Information Technology Goods (Requirements for Compulsory 
Registration) Order (CRO) Phase IV scope expansion, to include 12 new product categories, including 
keyboards, USB type external hard disk drives, USB type external solid -state storage devices , and 
stand -alone switch mode power supplies. We also greatly appreciate MeitY's 16 September 2020 
notice in the Indian Gazette, which extended the CRO implementation timeline by six months to 1 
April 2021 for the product categories included in the Phase I V scope. US industry is concerned about 
recent holds BIS has placed on processing the applications of foreign manufacturers, which disrupt 
US exports to India of 33 ICT products, including notebooks, tablets, and servers. These holds, which 
do not appear t o apply to in -country applicants, delay BIS certification of US products, disrupting 
trade and generating uncertainty for both exporters and consumers by impacting delivery timelines. 
These holds are of particular concern when they occur ahead of major sal es seasons, as they prevent 
full commercial participation by US manufacturers. More broadly, India's CRO requirements continue 
to raise concerns, including the requirement that product testing is performed exclusively by Bureau 
of Indian Standards -accredit ed labs located within India; and the failure to recognize test results 
from ISO/ IEC 17025 accredited laboratories.  
2.330.   The representative of Canada  provided the following statement. Canada recognizes and 
appreciates India's 9 October 2020 WTO TBT notification  G/TBT/N/IND/44/ Add.8  and its Gazette of 
India notification, of 16 September 2020, alerting suppliers to the delay, from 1 October 2020 to 1 
April 2021, of the expansion of the Compulsory Registration Order (CRO) to cover 12 additional 
products. Canada would like to highl ight the time it takes for firms to adapt to having their products 
tested in India and to make any adjustments to their products needed to meet Indian, instead of 
international, technical regulations. At considerable expense to the supplier, goods must be 
produced, shipped to India and testing conducted before compliance can be achieved. Canada 
continues to be concerned that the CRO does not allow for the use of international standards or 
recognize testing conducted in appropriately accredited foreign confo rmity assessment bodies. 
Canada would support a further delay in the implementation of the CRO until India adopts IEC 
standards and removes the high cost of complying with duplicative national standards.  
 
70 For previous statements follow the thread under IMS ID  367 (under dates raised and references) . G/TBT/M/82  
 
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  2.331.   In response, the representative of India provided th e following statement. We thank the 
United States for their interest in the Indian IT sector. As requested by the United States in the last 
TBT meeting, the date of implementation of the Order is extended until 1 April 2021 via Gazette 
Notification dated 1 6 September 2020. We note that the US has mentioned about BIS hold on 33  
information and technology products. But as per our record, there is no hold up in the processing of 
applications under CRS. The US may share the list of such applications for our exa mination and 
response.  
2.1.3.26   China - Registration Fees for Drugs and Medical Device Products (IMS ID 46671) 
2.332.   The representative of the Republic of Korea  provided the following statement. Korea has 
continuously raised concerns on registration fees for drugs and me dical device products in China 
through bilateral and multilateral channels and thanks China for kindly responding to Korea's 
enquiries. Nevertheless, we urge China to provide substantive replies to our questions and concerns. 
During the Trade Policy Review  in 2016, China stated that the registration fees will be re -evaluated 
every five years for proper adjustment. Hence, we would like to ask China information about the 
exact timeline for the registration fee adjustment. In addition, Korea calls for China on ce again to 
inform when the notification on Charging Standards for Drug and Medical Device Registration from 
2015 will be revised. We also request China to consider determining the registration fee of Chinese 
and foreign products in an equitable manner to provide equal treatment for domestic and foreign 
products. In the previous meetings, China explained that the differences between the registration 
fees of imported and domestic products were due to the fee for foreign inspection according to the 
quality ma nagement system. Korea would like to ask China to consider the possibility of charging 
the inspection fees as an additional cost and exclude them from the registration fee.  
2.333.   The representative of Australia  provided the following statement. As previously not ed in this 
Committee, Australia maintains an on -going interest in key developments in China's regulation of 
drugs and medical devices, including with regards to registration fees and processes for 
pharmaceuticals, complementary medicines and medical device s. These aspects remain of 
importance to Australian industry. Australia therefore continues to welcome constructive bilateral 
discussions with China on a range of health technology topics of interest to both sides, and to further 
cooperation and informatio n exchanges to enhance mutual understanding. In particular, the 
Australian Government welcomes the opportunity to explore opportunities for relationship building 
with the NMPA and the Pharmaceuticals Division of the Chinese Ministry of Industry and Informa tion 
Technology (MIIT).  
2.334.   In response, the representative of China  provided the following statement. The registration 
fees for drugs and medical devices were common international practice. For example, in 2013 the 
new medicine registration fees of Members we re mostly around 1 million Yuan, some Members even 
above 10 million Yuan, while it was only 35,000 Yuan in China. Afterwards, it is adjusted to 0.624 
million Yuan, which is still much lower than the average level internationally. The fees are mainly 
determ ined by the cost of the conformity assessment works. The difference of the registration fees 
is due to different workload and price level.  
2.1.3.27   India - Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulations, 2015, G/TBT/N/IND/51 , G/TBT/N/IND/104  (IMS ID 49472) 
2.335.   The representative of the Europea n Union  provided the following statement. The EU would 
like to reiterate again its concerns regarding this measure. We welcomed the publication of the 
regulation on additives for alcoholic beverages in August 2017. The regulation covering standards 
for alc oholic 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 h ad 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. We 
notably request Indian authorities to consider alignment with OIV standards. In particular, we would 
appreciate if India could take into account the following: The lack of stock -exhau stion clause and 
transition period. The presence of some technical specifications that may not be in line with 
international standards or with international widely -accepted practices. Some labelling requirements 
 
71 For previous statements follow the thread under IMS ID  466 (under dates raised and references) . 
72 For previous statements follow the thread under IMS ID  494 (under dates raised and  references) . G/TBT/M/82  
 
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  are excessive and will potentially trigger a dditional 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 controls. The EU welcomes the publication of the dra ft 
regulation related to non -alcoholic beer and certain food additives/colorants used for Campari and 
Aperol (dated 22 June 2020). We expect that the EU (and other third countries) will still have the 
possibility to comment on the draft legal proposal. We would like to learn about the timeline for its 
final approval and publication in the Gazette. We hope that we can continue our discussion and find 
an acceptable solution to the outstanding issues.  
2.336.   The representative of Australia  provided the following stat ement. Australia recognizes the 
right of the Indian Government to take measures necessary to protect public health. Australia wishes 
to emphasize the importance of compliance with WTO obligations, in particular the requirements 
that measures be implemented  in a non -discriminatory manner and in a way that is no more trade 
restrictive than necessary. Australia thanks India for revising its draft regulations to allow the 
addition of water to 70 ml/kg for certain technical purposes. These revised draft regulati ons go some 
way to addressing Australia's concerns, however, the revised draft regulations expressly prohibit 
adding water to dilute high sugar musts to limit the occurrence of "stuck " fermentation. This 
prohibition would restrict the ability of winemakers  to adapt to warming climates, both in Australia 
and India. In Australia, wine producers 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 mini mal circumstances, for technical necessity, in small volumes to aid fermentation during 
periods of difficult seasonal conditions. Australia requests that India allow the addition of water to 
dilute high sugar musts to aid in fermentation and revise the dra ft regulations accordingly.  
2.337.   The representative of Chile provided the following statement. Regarding the trade concern 
raised by the European Union and Australia about India's notification G/TBT/N/IND/51  of 2015, the 
delegation of Chile agrees with the comments made at this meeting by  the delegations that have 
already taken the floor.  
2.338.   In response, the representative of India provided the following statement. India would like 
to inform Members that the Food Authority in India has approved the Commonwealth of Australia's 
request, and the  draft regulations have been revised since. They are under the process of final 
notification.  
2.1.3.28   Russian Federation - Rules of cement certification, G/TBT/N/RUS/48 , 
G/TBT/N/RUS/49  (IMS ID 49773) 
2.339.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its previous st atements in the TBT Committee on this issue. The EU would also like 
to thank Russia for the very good bilateral held on this issue earlier today. The EU would like to 
recall that its comments on both Russian notifications G/TBT/N/RUS/48  and G/TBT/N/RUS/49  sent 
to the Russian Federation in May and June 2016 were  never replied to, despite our numerous 
reminders. The EU deeply regrets that Russia continues to adopt restricting measures in the area of 
cement certification that are disproportionate, unjustified and not notified to the WTO before their 
entry into forc e. Since the introduction of the mandatory certification for cement, EU exports of 
cement to the Russian Federation are practically blocked, with the exception of white cement, 
necessary for Russian industry. This situation remains unchanged since the entr y into force of these 
measures. In light of the above, the EU welcomed the 2019 announcement of the Russian authorities 
declaring that the standards on cement certification would be revised and a new standard eliminating 
additional inspection procedures wo uld be notified to the WTO at a draft stage, in line with the rules 
set out by the TBT Agreement. Given the lack of the notification to this day, the EU would like to ask 
the Russian Federation to inform about the state of play regarding the preparation of  this new 
standard and to share the updated timing for its TBT notification.  
2.340.   The representative of Ukraine  provided the following statement. Ukraine would like to share 
the concern raised by the EU and reiterate its statements made in the course of the pre vious TBT 
Committee meetings with regard to the clearly -identified overly trade -restrictive certification 
requirements for cement. Access to the Russian Federation market for cement depends on meeting 
the requirements established within the Eurasian Econom ic Union. These certification rules require 
conformity assessment of products. In particular, to be eligible for the conformity assessment the 
 
73 For previous statements follow the thread under IMS ID  497 (under dates raised and references) . G/TBT/M/82  
 
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  applicant must be a legal entity or individual proprietor, or producer or seller, or agent of a foreign 
producer.  This business relationship must be demonstrated via a written contract with the foreign 
producer, which must also be registered pursuant to the legislation of the Eurasian Economic Union 
member state on its territory. Requirements established for the appl icants related to their mandatory 
registration on the territory of member states of the Eurasian Economic Union create an additional 
burden for other WTO Members compared to producers in the Eurasian Economic Union and may 
contravene Article 5 of the TBT A greement. We welcome yet another announcement by the Russian 
authorities regarding possible amendments to the current regime and would like to encourage the 
Russian Federation to provide basic information requested by the WTO Members and comply with 
the fu ndamental WTO transparency commitment essential for predictable and non -discriminatory 
trade. Ukraine calls on the Russian Federation to restore conditions which will enable the flow of 
trade in cement again.  
2.341.   In response, the representative of the Russian Federation  provided the following statement. 
The measure at issue is aimed at fighting the illicit trade in cement and building materials and 
ensuring the strength of building materials which is of paramount importance for the durability of 
buildings. Curr ently, the amendments to GOST –R "Rules of cement certification " are being discussed 
internally among the relevant Russian authorities. However, no precise timeline for the outcome of 
the discussion can be provided now.  
2.1.3.29   Egypt - Manufacturer Registration Sys tem (Decree No. 43/2016 and Decree No. 
992/2015), G/TBT/N/EGY/114 , G/TBT/N/EGY/115  (IMS ID 50574) 
2.342.   The representative of the Russian Federation  provided the following statement. Russia would 
like to thank Egypt's representative for the bilateral engagement on the registration process. 
However, we remain concerned by the procedure of registration since it is untransparent and lacks 
clear deadlines  for the processing of applications which provides opportunities for arbitrary decisions 
regarding market access for particular companies and for protection of domestic industries from 
import.  
2.343.   The representative of the European Union  provided the following  statement. The EU would 
like to reiterate its concerns with regard to the registration of companies exporting to Egypt under 
Decree 43/2016. Most of the pending registration cases known to the EU have still not been 
successfully processed due to expired q uality certificates. Such certificates have a validity of one 
year, therefore they expired because the General Organization of Export and Import Control (GOEIC) 
failed to register the companies within reasonable time limits. As a result, the European compa nies 
are now confronted with additional costs and administrative burden of updating their registration 
applications. The EU finds it also very worrisome that around half of the non -registered companies 
are active in the sector of ceramic tiles. The EU cera mics sector 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. Moreover, the EU was informed about an announcement 
published on GOEIC's website requesting a number of companies, including EU operators, to update 
their quality certificates by 31 May 2020, otherwise they would need to restart their application 
process. A similar announcement was published also in early October 202 0 with a deadline of 
15 October 2020. These announcements were in Arabic only and the companies concerned were not 
informed about their publication. The EU would appreciate a confirmation from Egypt that all 
companies, which will submit updated quality con trol system certificates and complete in this way 
their application documents, will be registered without any further delay and without the need of 
restarting the entire application process. 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, still persist. The EU would therefore like to repeat its 
invitation to Egypt to suspend or further substantially improve the registration process with the 
objective to remove unnecessary obstacles to trade and to refer for details to the statements of the 
past TBT Committees.  
2.344.   The representative of Turkey  provided the following statement. Turkey would like to thank 
Egypt for continuing bilateral discussions on this issue in a constructive way. However, Turkey 
remains concerned on Egypt's Decrees on manufacturer registration system, since it is still unclea r 
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, and 
 
74 For previous statements follow the thread under IMS ID  505 (under dates raised and references) . G/TBT/M/82  
 
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  whether it is approved or not. Expectedly, companies are  facing long delays and bear additional 
costs in the registration process. Turkey would therefore like to once again ask Egypt to review this 
measure considering the principles and obligations in the WTO Agreements and ensure its 
implementation in full tra nsparency.  
2.345.   In response, the representative of Egypt  provided the following statement. We thank the 
delegations that maintained interest in this issue, we are also thankful for the bilateral exchanges 
on this matter in Geneva and in capitals. We would like hereby to refer to our previous statements 
on the positive steps undertaken by the government of Egypt to facilitate the registration process, 
address the specific problems of some individual companies and to enhance the transparency of the 
registration pr ocess. Egypt reiterates, once again, that the purpose of the registration system is 
solely to pursue the legitimate objectives of enhancing market surveillance and preventing deceptive 
practices, and in this spirit the Decree  hasn't set the registration to  be time bound, instead, the 
registration is valid as long as the documents presented by companies are valid. And for that we 
urge both registered companies and those in the process of registration to regularly update the 
documents presented to ensure that  the registration goes more smoothly. And while we are 
cognizant of the fact that a limited number of applications has been pending for some time, we 
would like to highlight that reforming the implementation of the system is a work in progress, and 
that so me of the efforts to address this issue have been effectively hindered by the COVID -19 
pandemic and the measures adopted by the government to limit its spread, which reflected 
negatively on the pace of work and on the coordination between different governm ental entities 
involved in the process. Finally, we encourage our partners with specific problems with the system's 
implementation to continue reaching out to us and to the capital in this respect, and from our side 
we will continue our follow up with Cair o and with the concerned delegations in Geneva.  
2.1.3.30   China - Cybersecurity Law (IMS ID 52675) 
2.346.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's "Cybersecurity Law " and would like to refer to the pre vious statement 
which we made at the last TBT Committee in May 2020. Japan is also concerned with related 
enforcement regulation. Japan would like to request that China provide notification of the 
enforcement regulations to the TBT Committee and consider c omments 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.  
2.347.   The representative of the Unite d States  provided the following statement. The United States 
remains very concerned about China's suite of cybersecurity and cryptography measures. As we 
have said in prior TBT Committee meetings, this is a major concern for US 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 
sometimes general in scope, and sometimes sector -specific. We have many concerns regarding 
China's Cybersecurity Law and related measures, which impose far -reaching, highly trade -restrictive 
condition s on foreign ICT products through "secure and controllable " requirements, enforced by 
cybersecurity review regime checks. Such requirements are largely based on a planned update and 
expansion of the Ministry of Public Security's MLPS.  
2.348.   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. Numerous other concerns have been laid out in prior interventions by the  United 
States and other Members at prior Committee meetings. Additionally, the United States reiterates 
its serious concerns regarding China's Cryptography Law, which went into effect on 1 January 2020. 
The United States is concerned that this law codifie s 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 widespread 
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. We also 
 
75 For previous statements follow the thread under IMS ID  526 (under dates raised and references) . G/TBT/M/82  
 
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  request that China afford subsequent opportunities for interested parties to submit commen ts 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 that China act deli berately 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 the Cryp tography Law. We look forward to continuing this important dialogue 
with you.  
2.349.   The representative of the European Union  provided the following statement. The EU would 
like to refer to the statement it has made in previous TBT Committees with regard to the 
Cybersecurity Law, namely that the scope of the requirements is unclear as key terms have still not 
been specified in sufficient detail. 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 what is considered as CII and which kinds of cross -
border data transfers are af fected. A definition of critical information appears to cover many 
commercial activities and whole sectors that have no bearing on national security. Moreover, the list 
of what is considered important data is open -ended, which has not been further clarifie d by the 
released draft for the Data Security Law in July 2020. As a result of the data localization and security 
assessment requirements, foreign companies operating in China could find themselves in a less 
competitive situation compared to domestic opera tors. The EU calls on China to implement the 
provisions in a non -discriminatory manner, respecting the principles of proportionality, necessity and 
technology neutrality, and ensuring adequate protection of intellectual property (IP). Moreover, the 
EU woul d like to repeat its previous requests for clarifications on the relationship with existing Multi -
Level Protection Schemes and the expected implementation timeline. The EU requests that China 
notifies draft measures concerning any sectoral implementation t o the TBT Committee in order to 
give adequate opportunity for WTO Members and their stakeholders to comment on any subsequent 
developments.  
2.350.   The representative of Canada  provided the following statement. China's Cybersecurity Law, 
which came into force on 1  June 2017, forms the overarching framework for China's extensive 
cybersecurity requirements. Many of the subsequent implementing measures, that build upon and 
interact with the law, are still in draft form and lack the clarity and precision needed to ensu re secure 
and predictable access to the Chinese market. For example, the definition of CII is an open -ended, 
imprecise list of broad sectors, which does not permit companies to assess adequately whether their 
infrastructure is classified as CII. In additio n, there is no clear commitment to the use of the 
international standards that exporters, from all countries, depend upon to construct the supply 
chains that underpin international trade. Canada seeks China's agreement to achieve the needed 
clarity and ado ption of international standards by either modifying the law, or providing, in its 
implementing measures, the clear definitions and commitment to international standards required. 
In the interim, Canada also seeks clarity on how China will implement the la w in the absence of a 
complete set of promulgated implementing measures.  
2.351.   The representative of Australia  provided the following statement. Australia appreciates 
China's efforts to consult with interested parties on its measures relating to cybersecurity, i ncluding 
China's recent public consultation on its draft Data Security Law, on which Australia made a 
submission in August 2020. Australia reiterates our previous position regarding China's 
Cyber security Law and related laws, including the Provisions on In ternet Security Supervision and 
Inspection by Public Security Organs. Australia respectfully reiterates our concerns that many details 
of these laws remain unclear. Australia notes that, consistent with the TBT Agreement, the measures 
should be implemented  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.  
2.352.   In response, the represent ative of China  provided the following statement. The purpose of 
Cyber security Law is to safeguard national sovereignty in cyber space, as well as national security 
and public interests, to protect rights and interests of citizens, legal persons and other o rganizations 
in China. There are three aspects in the definition of "secure and trustworthy ": firstly, the product 
or service providers shall not use their product or service to illegally obtain users' data, impairing 
users' disposition of data. Secondly, product or services providers shall not illegally control and 
operate users' equipment, impairing controllability of the equipment owned or operated by users. G/TBT/M/82  
 
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  Thirdly, product or service providers shall not seek illegal interest by making use of users' rel iance 
on the product or service, or operate monopoly, including stop providing reasonable safety technical 
support or force users to upgrade.  
2.1.3.31   European Union - Regulation (EC) No 1272/2008 (CLP Regulation) (IMS ID 
53976) 
2.353.   The representative of the Russian Fe deration  provided the following statement. The Russian 
Federation remains concerned with cobalt classification approved under the 14th Adaptation to 
Technical Progress to the Classification, Labelling and Packaging (CLP) Regulation and reiterates its 
statement made during the previous meetings of the Committee on TBT and the Council for Trade 
in Goods. The measure was adopted without any scientific justification and assessments of socio -
economic impact. As for direct consequences of this measure, while the CLP Regulation sets labelling 
and packaging requirements, it is clear that the Commission will go further and develop both 
industrial and product specific as well as technical regulation on the basis of this classification 
decision, which will set unjustif ied restrictions or prohibition for the cobalt use. Moreover, even 
without further restrictions, cobalt and cobalt -containing products consumption will unduly suffer 
due to their deselection as a result of stigmatization when manufacturing the final produc ts, such as 
electric vehicles' batteries, energy storage units and similar equipment critical to fight climate change 
and achieve green sustainability. However, we welcome the Commission's efforts and the progress 
achieved in the international approval of gastric bioelution at the level of the EU and the OECD. 
Could the EU inform the Members of the WTO on the state of work on approval of bioelution under 
the CLP Regulation? We also welcome recent information by the Commission stating that gastric 
bioelution  can now be applied when classifying alloys and compounds . We ask the EU to confirm this 
understanding. Finally, we request yet again the EU to share the scientific data that the EU used to 
classify cobalt as carcinogen for the oral route of exposure.  
2.354.   The representative of Brazil  provided the following statement. Brazil supports STC 539 
regarding  Regulation (EC) No 1272/2008. As previously stated, in the 14th review of adaptation to 
technical progress (ATP) for Regulation (EC) No 1272/2008, the reclassifica tion 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 
amounts within nickel production.  Restrictions on cobalt trade would therefore negatively impact 
nickel production in Brazil. Brazil is the primary nickel producing country in South America, exporting 
around 70 thousand tonnes of nickel, according to 2017 figures. According to industry es timates for 
the same year, the total value of nickel production reaches USD 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 re vising restrictions on the use of cobalt, while relying on 
sound scientific analyses to support its technical regulations with significant impact on trade.  
2.355.   The representative of Australia  provided the following statement. Australia would like to 
support th is STC. As previously noted in this Committee, Australia recognizes the European Union's 
right to regulate for public and occupational health and safety. We also recognize that appropriate 
classification and labelling for hazardous substances and mixtures can address legitimate public and 
occupational health concerns. However, Australia and other WTO Members have raised concerns on 
multiple occasions in this and other forums that these measures are more trade restrictive than 
necessary. Our concerns have fo cused on the potential of these regulations to create unnecessary 
obstacles to international trade in products containing titanium dioxide and cobalt, as well as the 
related raw materials. Noting that this regulation has been adopted, and will apply from O ctober 
2021, we urge the EU to ensure that the implementation of the regulation, including associated 
labelling and packaging requirements, is no more trade restrictive than necessary. We also urge the 
EU to ensure that the implementation of these measures  has the least possible impact on 
downstream products containing titanium dioxide and cobalt, including but not limited to: stainless 
steel products, which may contain trace amounts of cobalt in concentrations greater than the generic 
limit of 0.1% applied  in the regulation; as well as related raw materials, for example, cobalt is 
increasingly used in battery technology.  
2.356.   The Australian chemical, cosmetic, medicament, paint and resources sectors remain 
concerned about implementation of this measures. The EU has provided some information on the 
downstream consequences for titanium dioxide. We would welcome a further response to our 
 
76 For previous statements follow the thread under IMS ID  539 (under dates raised and references) . G/TBT/M/82  
 
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  concerns regarding products containing trace amounts of cobalt, noting that the adopted regulation 
retained the classification of cobalt as a carcinogen through all routes of exposure, rather than 
limiting the classification to inhalation only. We welcomed the final EU classification being limited to 
mixtures containing titanium dioxide that are placed on the market in powder form wi th a diameter 
smaller than 10 micrometre. Nonetheless, there remains some confusion from Australian industry 
around the requirements for products that contain titanium dioxide in a non -powdered form, for 
example in paint, complementary medicines, and sunsc reens. For liquid mixture products, there is 
still an obligation to update labels with a warning that could have detrimental reputational and trade 
impacts.  
2.357.   In response, the representative of the European Union  provided the following statement. We 
would li ke to thank the Russian Federation for a very fruitful bilateral we held on this issue earlier 
today. The Commission Delegated Regulation amending the CLP Regulation was published in the 
Official Journal of the EU in the beginning of 2020 and the classific ation of cobalt will become 
applicable as of 1 October 2021. The classification of cobalt is based on the independent scientific 
opinion of ECHA's Risk Assessment Committee (RAC), which takes into account all scientific 
information available, including the  information available in the dossier submitted by an EU member 
State (The Netherlands) and from the public consultation that is part of the process to arrive at an 
EU-wide harmonized classification. In addition, all comments sent to the TBT Committee by W TO 
Members were distributed to member States and they were duly taken into account by the 
Commission and the member States in the decision -making process. Moreover, it should be taken 
into account that the Commission considered that the method used to dete rmine the Specific 
Concentration Limit of 0.01% should be assessed in order to discuss if the method is relevant for 
inorganic compounds like cobalt. For this reason, the entry in Annex VI to CLP for cobalt is without 
such specific limit and the generic li mit of 0.1% will therefore be applied.  
2.358.   The EU would like to reiterate that, in line with the UN GHS (UN Globally Harmonized System 
of Classification and Labelling of Chemicals), the classification of any substance is based on a hazard 
assessment and not on  risk assessment. It should be noted that classification 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 consid erations 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 harmo nized classification, only labelling and packaging obligations are 
triggered for that substance and any mixture containing it, but not for articles (e.g. cutlery or other 
stainless steel articles). As also mentioned in reply of 23 September 2020 to the let ter sent by the 
Russian Minister for Economic Development, Mr Reshetnikov, to Mr. Sinkevičius, the EU 
Commissioner for the Environment, the EU made progress in the development of a harmonized 
approach at international level on the use of the bioelution met hod. Recently, the EU Reference 
Laboratory for alternatives to animal testing (EURL ECVAM) Scientific Advisory Committee (ESAC) 
gave a positive opinion on the scientific validity of a bioelution test method, developed by the metals 
industry to assess the r elative in -vitro bioaccessibility of metals and metalloids in inorganic metal 
compounds and metal (metalloids) -containing materials using a simulated gastric fluid.77 
2.359.   On the basis of this positive opinion, the method was proposed by the European Commission  
in November 2019 at OECD level for acceptance as a technical guideline. In May 2020 the OECD 
Working Group of the National Coordinators of the Test Guidelines Programme accepted the 
Commission's proposal and an OECD subgroup should be set up to work on th e technical guideline. 
Relevant industries are already using the results of the experimental bioelution test to classify their 
alloys in accordance with article 12(b) of the CLP Regulation. No legal amendment of this article is 
required to use this method.  The classification of alloys is not subject to harmonized classification 
but it is under the sole responsibility of the industry. Most probably, the companies producing metal 
alloys and compounds containing cobalt traces are using such bioelution data for  classifying their 
alloys. However, in order to further examine this approach and to ensure a proper use of the 
experimental data obtained from the bioelution method, a European expert group has been created 
with the participation of experts of member Stat es and metal industries. The first meeting of this 
group took place in September 2020, and further meetings of the group will take place to achieve 
the goals described above.  
 
77 https://ec.europa.eu/jrc/en/publication/eur -scientific -and-technical -research -reports/esac -opinion -
scientific -validity -bioelution -test-method   G/TBT/M/82  
 
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  2.360.   With regard to the classification of cobalt as carcinogen for all routes of expos ure, including 
the oral route, the EU would like to reiterate that the approach taken is in line with both the UN GHS 
and the CLP Regulation. In particular, the UN GHS stipulates the following in Table 3.6.2: Label 
elements for carcinogenicity: "state rout e 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, i.e. the 
scientific data available were not sufficient to conclusively exclude that the oral route of exp osure 
causes the hazard. A potential re -examination of the classification as regards routes of exposure can 
only be considered if new and relevant data from scientific studies, conclusively demonstrating the 
absence of carcinogenic effects from oral or der mal routes of exposure, become available. In view 
of the time needed for such test results to become available, there was no scientific and legal 
justification to exclude the oral route. In case new scientific information becomes available in the 
future, a n amendment could only be envisaged following a revised RAC opinion.  
2.1.3.32   European Union - Regulation (EC) No 1107/2009 - non-renewal of approval of 
the active substance picoxystrobin, G/TBT/N/EU/437  (IMS ID 53578) 
2.361.   The representative of Brazil  provided the following statement. Brazil would like to express 
its concerns regarding the EU's non -renewal of picoxystrobin registries and to refer to our previous 
interventions on the matter. 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 MRLs for seven substances, including picoxystrobin 
and buprofezin, which are important for Brazil's exports of agricultural comm odities. We consider 
that the transitional period provided for producers to adapt to the new MRLs was unreasonable, 
given that studies conducted by EFSA were inconclusive, not based in due risk analysis and 
inconsistent with Codex guidelines. Council Direc tive 91/414/EEC of the European Commission 
declared that picoxystrobin was not toxic, the report of the EFSA claimed that it was not possible to 
deliver final conclusions on the genotoxic potential of picoxystrobin based on the available data. The 
Food and  Agriculture Organization and the World Health Organization 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 EPA, the Canadian Managem ent 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 
0.01mg/kg. In light of the above, we res pectfully 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.  
2.362.   The representative of Colombia  provided the following statement. The delegation of 
Colombia wishes to express its systemic interest in this matter, given that this EU measure is related 
to other specific trade concerns placed on  the agenda of this Commit tee, and on which it has already  
made statements.  
2.363.   The representative of Paraguay  provided the following statement. Paraguay refers to its 
statement under European Union - Hazard -based approach to plant protection products and setting 
of import tolerances (IMS ID 393 ), para. 2.215.    
2.364.   In response, the representative of the European Union  provided the following statement. As 
explained in detail at several TBT Committees, the European Com mission decided not to renew the 
approval of picoxystrobin through Commission Implementing Regulation (EU) 2017/1455. 
Authorizations for plant protection products containing picoxystrobin in the EU were to be withdrawn 
by 30 November 2017. Member States co uld allow 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 did not amend 
the M RLs and provided for a grace period for use of products containing picoxystrobin. Given the 
issues identified by the EFSA, in January 2019, the Commission lowered the existing MRLs to the 
limit of quantification (LOQ). The European Union notified third cou ntries of the draft Regulation 
lowering the MRLs via the SPS Committee and they are applicable since 13 August 2019. Import 
tolerance requests 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 relevant concerns.  
 
78 For previous statements follow the thread under IMS ID  535 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.33   China - Catalogue of Solid Wastes Forbidden to Import into China, 
G/TBT/N/CHN/1211  (IMS ID 54579) 
2.365.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and supports the right of all WTO mem bers 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 th is 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 rec alls that China itself is the largest global producer 
of vanadium slag, with approximately 500,000 tonnes annual production generated as a co -product 
from steel mills. 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 products. 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 ne cessary to achieve China's 
environmental and health protection objectives. New Zealand 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 disting uishing between waste and non -waste materials.  
2.366.   The representative of Canada  provided the following statement. Canada wishes to reiterate 
past comments and concerns that we have shared on this STC since it was first put on the agenda 
of the Committee in Mar ch 2018, most recently in May 2020 .80 
2.367.   In response, the representative of China  provided the following statement. China has been 
pushing for ecological progress, pro -actively practising the values of "sustainable development" and 
"green development" in order to meet the Chinese people's ever -growing need for a beautiful eco -
environme nt and aiming to solve significant outstanding environmental  problems. Advancing the 
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 internationally 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 l argest 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 
recycli ng 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 ha d huge negative impacts on 
human, animal, and plant life and health, China considers 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.  
2.368.   In the process of adjusting the solid wastes imports policies, Chinese government has 
adequately taken into account voices at home and abroad, and adjusted the Import Waste 
Management Catalogue in different batches. China h as also set a sufficient transition period for the 
relevant industries, and has fulfilled transparency obligations under the WTO rules. Meanwhile, China 
allows solid wastes processed into raw materials that meet the relevant national quality standards 
to enter China by trade. Over the past decades, enterprises from other WTO Members have exported 
large quantities of solid wastes to China and derived huge financial gains. China earnestly hopes 
that these Members could also actively fulfil their international  social responsibility and make 
contributions to the global environmental protection. It has been noticed internationally that cross -
border transfers of plastic, electronic and other wastes to developing Members brings serious 
environmental pollution and i nternational society are actively taking measures. In May of 2019, the 
14th session of the Conference of the Parties to the Basel Convention, more than 180 parties agreed 
on the plastic waste amendments, to strengthen the control of plastic waste cross -border transfers, 
and to establish the partnership of plastic waste, driving the common action globally in response to 
plastic pollution. The convention has set up an expert working group to strengthen controls on cross -
 
79 For previous statements follow the thread under IMS ID  545 (under dates raised and references) . 
80 G/TBT/M/81 , para. 1.419 . G/TBT/M/82  
 
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  border movement of e -waste. 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 searc h 
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.  
2.1.3.34   Viet Nam - Cybersecurity Measures (IMS  ID 54481) 
2.369.   The representative of the United States  provided the following statement. The United States 
remains concerned about Viet Nam's proposed data localization measures in its draft cybersecurity 
decree. We look forward to Viet Nam amending this draft  measure in a transparent manner to 
address concerns that we and other WTO Members have raised, in order to ensure that the 
Cybersecurity Law is implemented in the least trade -restrictive manner possible. Does Viet Nam 
have any updates to share on the stat us of the draft decree?  
2.370.   The representative of Canada  provided the following statement. Canada wishes to reiterate 
its statement from the May 2020 meeting .82 Canada continues to seek an update from Viet Nam on 
its implementation of the Cybersecurity Law, in cluding the status of the draft decree implementing 
it and planned future actions.  
2.371.   The representative of Australia  provided the following statement. We share other Members' 
concerns with a number of concepts in Viet Nam's Cyber security Law. Australia and o ther Members 
have provided feedback on Viet Nam's draft decree implementing the new law, noting our interest 
in seeing a law that: maintains Viet Nam's entrepreneurialism and embrace of digital platforms; 
supports increased participation in global e -commer ce; and enhances the business environment in 
Viet Nam, including by being transparent, clear and compliant with  international trade commitments 
and regional trade agreements. We share the view that safeguarding cybersecurity is a legitimate 
policy objectiv e of governments. But we continue to question whether requirements in the law and 
draft implementing decree are necessary to meet Viet Nam's cybersecurity objectives. The current 
laws do not represent the least trade -restrictive manner to achieve those obj ectives. This may affect 
Viet Nam's reputation as an open economy and impact its ability to benefit from the digital economy 
and Industry 4.0. We look forward to continuing to work with Viet Nam on the implementation of 
the Cyber security Law and thank Viet  Nam for its engagement on this matter.  
2.372.   The representative of the European Union  provided the following statement. The European 
Union shares the Member's concerns on the Vietnamese Cyber security law as regards its potential 
economic impact and its compatib ility with Viet Nam's commitments under the WTO. The European 
Union would like to have an update on the draft Implementing Decree on Cybersecurity and invites 
the Vietnamese government to seriously consider EU concerns and continue the dialogue to ensure 
alignment to international best practices. We would also appreciate indications 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 Viet Nam 
notifies the Cyber security law, the draft Implementing Decree and any other planned implementing 
measures to the TBT Committee, in accordance with Article 2.9 of the TBT Agreement. The European 
Union encourages Viet Nam to de velop and implement Cyber security measures in full respect of 
WTO principles, such as non -discrimination and proportionality and to take into consideration 
available international standards and practices.  
2.373.   In response, the representative of Viet Nam  provide d the following statement. We thank the 
United States, the European Union, Australia, and Canada for their continued interest in  our 
legislative drafting process for the Decree to implement certain articles of  the Cybersecurity Law. 
Viet Nam would like to reiterate that our process has been transparent with an open mind. All 
stakeholders ' comments have been reviewed  for continuing internal consideration.  
 
81 For previous statements follow the thread under IMS ID  544 (under dates raised and references) . 
82 G/TBT/M/81 , para. 1.425 .  G/TBT/M/82  
 
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  2.1.3.35   Brazil - Technical Regulation 14, 8 February 2018, to set the additional official 
identity, quality stan dards 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/613   
G/TBT/N/BRA/956  (IMS ID 56883) 
2.374.   The representative of the European Union  provided the  following statement. The European 
Union would like to refer to the points raised in the previous TBT Committees. The European Union 
notes that Brazil is in the lead of several working groups in OIV that work on issues relevant to our 
bilateral trade, such  as categories of sparkling wines related to sugar content, import documentary 
evidence and list of analytical parameters for imports. The European Union appreciates the efforts 
of Brazil to seek international consensus within the OIV framework. In this co ntext, the European 
Union would like to reiterate the invitation to Brazil to make use to the maximum extent possible of 
the recommendations of the OIV when revising the relevant technical regulations and to remove the 
current requirements that are not in line with the OIV standards on identity and quality of wine and 
on maximum content limits. In addition, the European Union would also like to stress that the 
certification obligation on methyl alcohol and the systematic counter -analysis of certification 
parameters at border continue creating difficulties for EU wine exporters. The European Union is 
prepared to work bilaterally with Brazil in this respect.  
2.375.   In response, the representative of Brazil  provided the following statement. Regarding OIV 
standards, it  is important to stress that Brazil indeed leads several OIV working groups and we aim 
to align our regulations with the organization's standards . Furthermore, Brazil wants to highlight 
that there is no OIV standard setting out a list of parameters to be u sed as a guidance for the 
international trade of wine. 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 o f grape and wine products. Brazil considers that technical 
regulations (TRs 14, 48, and 75) are necessary to guarantee the quality of wines consumed in 
national territory, included the obligation analysis on methyl alcohol and the certification parameters 
at the border. 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 subsequent Technical Regulation 67, notified as 
G/TBT/N/BRA/853 , the m odels 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.  
2.376.   Technical Regulation 75, on the other hand, establishes the analytical parameters that m ust 
be included in the laboratory reports used in the inspection and control of imported and national 
beverages. These analytical parameters are set out in Operational Standard No. 1, of 24 January 
2020. Therefore, the number of parameters is reduced to se ven, 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 Techn ical 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 
trade -facilitating measure when compared to past regulations. Brazil is a growing wine consume r 
and producer, a condition that entails regulatory action for the sector. When developing new 
regulations on wine, Brazil will continue to abide by WTO rules.  
2.1.3.36   Russian Federation - Federal law No 487 -FZ, providing a framework for 
comprehensive use of speci al 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 56784) 
2.377.   The representative of the European Union  provided the following stateme nt. 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 
 
83 For previous statements follow the thread under IMS ID  568 (under dates raised and references) . 
84 For previous statements follow the thread under IMS ID  567 (under dates raised and references) . G/TBT/M/82  
 
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  product category. The EU has very serious concerns  on the proportionality of the measure: individual 
labelling and registration creates significant 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. Therefore the EU requests that Russia reviews the 
scope of products covered by the measure so that this focuses on high -value products for which 
there is evidence of a high level of counterfeit and/or tax avo idance. 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 significant effect on the trade of other Members". Therefore, this 
measure should have been notified under the TBT Agreement before its adoption. The EU would like 
to request the Russian Federation authorities to prepare a comprehensive guideline providing 
exhaustive information on technical details such as: timetable of g oods 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 guideline would significantly facilitate situation for a majority 
of economic operator s, both foreign and Russian. The Russian government adopted Resolution 
No 515 on 26 April 2019 on the "marking of goods subject to mandatory labelling by means of 
identification ". Of course, this measure also falls within the scope of the TBT Agreement and  needs 
to be notified to the WTO. In accordance with the TBT Agreement, sufficient time shall be provided 
to industry to adapt to the requirements necessary for placing products on the market of the Russian 
Federation, which is in general six months.  
2.378.   Some deadlines for labelling of individual product groups have been postponed, but an 
unclear situation remains on the ground. These postponements for different categories seem to be 
largely linked to the system not yet being operational. Operators, both Russia n and foreign, need 
additional time to ensure that all products to be placed on the market of the Russian Federation can 
comply. Introducing changes in the production cycle ahead of the implementation date is difficult, 
as crucial information on 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. Therefore, 
an extension of transition period is necessary, during which import and/or sale of non -labelled 
production to Russia would be allowed. This transition period should last at least until the end of 
2021 and should cover all products for which labelling started in 2020 and those planned for 2021. 
Current deadlines seem to be the following: Footwear – started on 1 July 2020; Medicines - started 
on 1 July 2020; perfumes and eau de toilette - started on 1 October 2020; photo cameras – started 
on 1 October 2020; tyre s - 1 November 2020; textiles - 1 January 2021; dairy - 20 January 2021 
and 1 October 2021.  
2.379.   Additionally, pilot projects for labelling of bottled water is on -going and for beer is supposed 
to start soon. According to public statements of the Minister for Industry and Trade, Mr. Manturov, 
labelling of these products is supposed to start in the fir st half of 2021. Producers of both types of 
products have already announced that the share of counterfeited products in these two segments is 
close to zero and obligatory labelling would considerably raise final prices for consumers. Therefore 
we would lik e to invite Russian authorities to publish a corresponding analysis providing an overview 
of counterfeit in segments of bottled water and beer. We ask the Russian Federation to take into 
consideration the European Union's comments, to ensure that the imple mentation of this measure 
is not unecessarily trade restrictive, in accordance with the WTO TBT Agreement.  
2.380.   In response, the representative of the Russian Federation  provided the following statement. 
The Russian Federation reiterates its statements made dur ing the previous meetings of the 
Committee on TBT and sticks to the position that the measure at issue cannot be considered as the 
technical regulation due to the fact that the system does not meet the requirements stipulated in 
the Agreement on TBT for te chnical regulations. The labelling requirements in technical regulations 
refer to fulfilling the technical requirements indicated in technical regulations. We emphasize that 
the track and trace system is not aimed at securing fulfilling the requirements st ipulated in the 
relevant technical regulations. Besides, the labelling 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». Track and  trace does not apply to the product characteristics or 
their related processes and production methods. The legislation and comprehensive guidelines 
regulating the track and trace, whether effective or drafts, are publicly available in the information 
system of "Chestiyznak " as well as the information about planned pilots and the volume of issued G/TBT/M/82  
 
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  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 i n the Russian and English 
languages.  
2.381.   We do not consider the system as disproportionate or burdensome as the concept in respect 
of each type of products has been elaborated  in collaboration with the companies involved in 
manufacturing, supplying and importi ng the products covered. In addition, the price of one data -
matrix code is approximately half of a ruble that is less than one US cent. In addition, according to 
the statistics made by the Operator of the System approximately 15 billion codes have been iss ued 
for tobacco products, 2 billion codes for shoes, 4 billion for pharmaceuticals, about 36 million codes 
for textiles. These figures show that market participants adapted to the system, its functioning is 
stable, and all the negative forecasts in respect  of disruption of traditional trade flows due to the 
Track and Trace System are not confirmed. We note hereby that the guidelines for each type are 
available on "Chestniy Znak ". As for challenges faced by small enterprises, we note that importers 
ensure ap pliance Track and Trace in respect  of products either at 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 terr itory of Russia determine 
the mechanism of application of the s ystem . 
2.1.3.37   China - Cosmetics Supervision and Administration Regulation and Regulation for 
Notification of Non -special Cosmetics, G/TBT/N/CHN/1310 , G/TBT/N/CHN/1311 , 
G/TBT/N/CHN/1331 , G/TBT/N/CHN/1453 , G/TBT/N/CHN/1454 , G/TBT/N/CHN/1459 , 
G/TBT/N/CHN/1460  (IMS ID 57685) 
2.382.   The representative of Japan  provided the following statement. As for "Cosmetics Supervision 
and Administration Regulation ", we would like to reiterate the following points. In terms of provisions 
related to disclosure of new ingredients and efficacy testing materials, Japan requests  that the scope 
of disclosure be clarified so as to exclude confidential corporate information. The regulation provides 
that "cosmetics registrants or filers " are the persons responsible for quality, safety and efficacy of 
cosmetic products. However, the r egulation and "Administrative Measures on Cosmetic Labelling " 
provides that the label should indicate "cosmetics registrants or filers " and "cosmetics producers or 
its contract producers ". In order to avoid confusion, Japan requests that the label should i ndicate 
only "cosmetics registrants or filers " who are a single responsible person. Furthermore, Japan still 
has concerns related to the "Management Rules for Testing required for Cosmetic Product 
Registration and Notification ", which was enforced on 12 Se ptember 2019. We would like to reiterate 
the following three points. Regarding testing laboratories, Japan requests a more flexible framework 
in which test results obtained by in -house or foreign laboratories through internationally recognized 
practices su ch as ISO can be accepted. As for the efficacy evaluation, China has not provided detailed 
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 "Management 
Rules for Testing require d for Cosmetic Product Registration and Notification " and "Regulation for 
Notification of Non -special Cosmetics ". Japan requests that China ensure consistency between those 
regulations.  
2.383.   Moreover, regarding "Interim Measures on the Administration of Oversea s Inspections of 
Cosmetics ", Japan would like to continue to express concerns on the following three points. Japan 
would like to request that China clarify which laws and regulations authorities are to use to determine 
conformity and specific purposes for conducting overseas 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 p roduct 
research and development stage is broader than necessary, and it causes unnecessary burdens for 
companies. The main purpose of the inspection seems to be to ensure product safety. Information 
related to research and development is not necessarily es sential for product safety assurance, while 
it is the most confidential corporate information. Therefore, R&D departments of companies should 
be excluded from the coverage of overseas inspections. Furthermore, inspections for domestic 
Chinese 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 
 
85 For previous statements follow the thread under IMS ID  576 (under dates raised and references) . G/TBT/M/82  
 
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  necessary for the legitimate purpose of the inspection, since production sites also contain confidential 
corporate information. Finally, we would appreciate it if China could provide the detailed timeline for 
these revision processes. Japan would like  to request that China provide an adequate grace period, 
at least one year after promulgation of all relevant regulations in order to allow time for producers 
to adapt to new cosmetic regulatory system.  
2.384.   The representative of the United States  provided the following statement. The United States 
is supportive of China's objective via CSAR to modernize and streamline its system of cosmetics 
regulation to the benefit of Chinese and US consumers. We note that China is conducting domestic 
consultations on several  important draft measures to implement CSAR. Because such measures are 
expected to have a significant effect on trade, we request that China notify the WTO of all CSAR 
implementing measure and standards; provide a minimum of 60 days for WTO Members and ind ustry 
to comment; consider the comments submitted by WTO Members and industry; and, then re -notify 
to the WTO any measures for which significant comments are made, before final versions are 
adopted. We ask that China clarify what is considered a relevant G MP certification so as to exempt 
importers from having to submit animal toxicological testing for market access. Because the United 
States Food and Drug Administration, by law, cannot issue GMP certifications for general cosmetics 
products, please confirm that China will accept a certification from a national trade association and/or 
a third -party certifier aligned with ISO 22716 Cosmetics – GMP – Guidelines on GMP. If not, we ask 
that China explain why importers are required to submit the results of animal  toxicological tests, 
while companies manufacturing in China are not subject to such requirement.  
2.385.   While we appreciate China's commitment to streamline its procedures for approving new 
cosmetics products and ingredients, we are concerned that NMPA new filin g and registration 
requirements, which are more extensive than what was required previously, may be requiring more 
information than necessary to fulfil its objective of managing product safety in China's cosmetics 
marketplace. NMPA's requirement that compa nies disclose their CBI including product formulations, 
manufacturing processes, ingredient specifications, and suppliers to local testing and responsible 
agents increases the risk of unauthorized disclosure of companies' CBI and trade secrets to 
competito rs. NMPA should not require companies to disclose CBI and trade secrets to local testing 
and registration agents as a condition to access the Chinese market. NMPA should also consider if 
the required disclosures are necessary for the legitimate exercise of  its regulatory authority, as 
cosmetics generally are lower risk compared to medical products. NMPA can access this information 
via post -market inspections if concerns with the safety or claims made for specific product or 
ingredients are identified.  
2.386.   When disclosures of CBI and potential trade secrets are necessary, NMPA should develop 
systems to identify and to safeguard cosmetics rights holders' IP and legitimate commercial 
interests, consistent with TBT and other relevant WTO IP commitments. We also ask that NMPA work 
with industry to develop a system for public disclosures of claims that supports consumer interest 
in innovative products while also safeguarding companies' investments in technology and testing in 
the least trade -restrictive manner. US FDA employs cosmetic product category codes to indicate a 
product's intended use. In developing its cosmetics classification system, NMPA should be wary of 
prescriptive classifications, or product standards that emphasize certain manufacturing processes or 
specific formulations to create a product. Cosmetics companies should be encouraged to develop 
innovative new products and ingredients, so long as they can also address the safety of their 
formulations for the anticipated users and uses. The success of China' s cosmetics and personal care 
industry is important to the United States given both the number of Chinese products used daily by 
American consumers, as well as the economic opportunity China represents to US companies seeking 
to serve China's growing consu mer base. The industry represents an example of the potential for 
expanding our bilateral trade.  
2.387.   The representative of the Republic of Korea  provided the following statement. Korea supports 
China's objectives of assuring the quality and safety of cosmetics  through the comprehensive 
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, under the Regulation, China requires the disclosure of the summary of 
scientific evidence that support cosmetic efficacy claims, which contain trade secrets. Also, China's 
labelling requirements differ from the international practice. With regard to these issues , Korea 
reiterates the concerns it raised regarding the previous STCs on the "Provisions for Cosmetic G/TBT/M/82  
 
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  Registration" and the "Administrative Measures on Cosmetic Labelling" .86 Above all, the revision of 
the "Cosmetics Supervision and Administration Regulati on" is needed as the matters prescribed in 
the regulation are reflected in its subordinate provisions and measures. Thereby, Korea urges China 
to consider the comments from Korea and other Members into revision. Second, 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 
laboratories in China are known to have obtained CMA. Thus, Korea would like to reques t China to 
offer flexibility to foreign laboratories in granting CMA and to recognize test results issued by foreign 
laboratories or internationally recognized laboratories, including test reports submitted for the 
registration of cosmetic products.  
2.388.   Third,  under the draft of "Cosmetics Supervision and Administration Regulation, " the licence 
for special -use cosmetics has validity periods. The licence issued by most of the countries including 
Korea, the US, and European states does not have a determined valid ity period. To harmonize 
cosmetics regulations, Korea requests that China reconsider setting the validity periods of the licence 
for special -use cosmetics. During the last TBT Committee meeting, China replied that it will take full 
consideration of the com ments from the Members. However, the finalized draft of the Cosmetics 
Supervision and Administration Regulation does not seem to be reflecting them. Hence, we request 
China to take into account our comments and look forward to receiving a response from Chi na. 
2.389.   The representative of Australia  provided the following statement. Australia welcomes efforts 
by China to modernize and simplify its regulatory system for cosmetics. We hope China will provide 
commercially viable alternative to testing on animals. We al so welcome the progress made by China 
in clarifying how its new CSAR will be implemented, including notification to the WTO of new draft 
provisions, guidelines and rules ( G/TBT/N/CHN/1453 , G/TBT/N/CHN/1454 , G/TBT/N/CHN/1459 , 
G/TBT/N/CHN/1460 ). Austral ia would also welcome details from China on any further cosmetics 
measures to implement the CSAR, including intended content and timelines. We encourage China to 
notify all cosmetics measures and to provide WTO Members with an opportunity to comment. To 
comply with Chinese requirements, businesses exporting cosmetics to China will also need a clear 
understanding of China's regulatory framework and any applicable measures. Australia requests that 
China base technical requirements for cosmetics on relevant in ternational standards in line with the 
WTO TBT Agreement. Australia also urges China to ensure that its regulations, including ingredient -
based safety assessment standards and risk -based categorization are aligned with international 
practices to ensure tha t risks to human health are managed in a way that minimizes the impact on 
trade. We strongly encourage China to provide equal treatment for Chinese and foreign cosmetics. 
Like other WTO Members have also indicated, Australia encourages China to limit admin istrative and 
documentation requirements to those that are strictly necessary, including in relation to disclosures 
of commercially sensitive information. Australia would welcome the opportunity to engage bilaterally 
in discussion on cosmetics regulation t o promote mutual understanding of our respective regulatory 
systems for cosmetics.  
2.390.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Japan, Korea, the United States, and Australia. Th e EU welcomes 
the new CSAR that has the potential to create an equal treatment of domestic and imported non -
special cosmetic products. It can move China significantly further towards a modern cosmetics 
legislation based on industry responsibility and safet y assessment. Such higher international 
compatibility of Chinese cosmetics regulation will benefit Chinese consumers, the development 
progress of the Chinese cosmetics industry and multilateral trade in cosmetics. To achieve fully the 
objective of equivale nt treatment of domestic and imported products, the EU is of the opinion that 
some requirements could be clarified to better acknowledge and accommodate differences in 
manufacturing between China and its international trading partners in the administrative  
management of cosmetic. The proposed draft Regulation for Notification of Non -special Cosmetics 
(G/TBT/N/CHN/1331 ) enables importing companies to confirm completely the safety of the product 
based on safety assessment, granting an exemption from toxicological tests carried out o n animals. 
This exemption is conditional to submission of a certificate of the production quality management 
system by a regulatory body. The EU understands and welcomes that this aims at creating an 
equivalent requirement to the pre -market manufacturing l icensing requirements applicable to 
domestic manufacturers.  
 
86 China – Provisions for Cosmetics Registration (Draft for Comments) (IMS ID 641) and China – 
Administrative Measures on Cos metic Labelling (IMS ID 642).  G/TBT/M/82  
 
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  2.391.   However, in many countries or regions, including the EU, the administrative management of 
cosmetics manufacturing is not based on a pre -market licensing approach but on in -market control. 
Therefor e, in most EU member States, the respective authorities may not have a legal basis for 
issuing such certificates. In most countries, including the EU, companies manufacturing cosmetic 
products are obliged to follow GMP and attest this in the mandatory prod uct information file. 
Authorities have the obligation to carry out in -market controls, including control of compliance with 
the GMP requirement at an appropriate scale at a random basis but also in case of suspicion of 
quality issues. The EU is of the opin ion that in principle, company -issued GMP certificates from 
manufacturing sites in countries with a functioning in -market control system should therefore be 
considered as sufficient, especially when done in conjunction with overseas inspections by Chinese 
authorities in case of suspicion. Therefore, in order to acknowledge and accommodate the 
administrative differences across the world, the EU would like to kindly propose to Chinese 
authorities a range of options for consideration as equivalent and valid wi th regard to the type of 
document and the organization issuing it such as manufacturing licence, Quality management/GMP 
certificate or inspection/audit conclusions. Such documents can be issued by state regulatory 
authorities, local authorities (e.g. provi ncial or municipal) or industry associations recognized by 
authorities to issue such a document. This range of options will allow companies to obtain a relevant 
statement and comply with the proposed requirement, adapted to the legal and administrative 
management system of the country of manufacture. The EU would appreciate knowing to what 
extent the EU comments of 24 July 2019 on the draft Regulation for Notification of Non -special 
Cosmetics (G/TBT/N/CHN/1331 ) have been or will be taken into account, and whether the notified 
meas ure is still at a draft stage.  
2.392.   In response, the representative of China  provided the following statement. Thanks to Japan, 
the US, Korea, Australia and the EU for raising this concern and for your positive experience sharing 
and suggestions. We would like to clarify following points regarding the protection of trade secrets 
in the registration and filing materials. As health -related products, materials as product formula  and 
production process of cosmetics are an important basis for product safety technical  review. 
Registrants and recorders are required to submit safety -related materials, which are also the general 
rules of many Members to review the safety of health -related products. The product safety 
information submitted by enterprises is not the content  of government information disclosure. 
According to Chinese government information disclosure regulations, administrative agencies should 
not make public government information containing commercial secrets, personal privacy or other 
elements which may cau se damage to legitimate rights and interests of third parties after disclosure. 
Therefore, no situation as leak of trade secrets mentioned by Members exists in the cosmetics 
registration and filing process. As the issue of alternatives to animal testing, t he notified draft placed 
exactly the same requirements in setting up alternative plans for animal testing for safety evaluation 
of imported and domestic cosmetics. Regarding the requirements for cosmetics registration and 
filing materials, the contents req uested to be submitted for imported and domestic products are 
exactly the same. Based on the principle of equal treatment between import and domestic 
productions, regarding the issue of exemption from animal experiments, both kinds of ordinary 
products are  required to hold production licences or documents related with good manufacturing 
practice issued by government supervision departments. This is not only measures on ensuring 
product quality and safety, but also a concrete embodiment of the principle of n on-discrimination.  
2.1.3.38   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 an d 
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes), 
G/TBT/N/EU/609  (IMS ID 57587) 
2.393.   The representative of China  provided the following statement. China thanks EU for former 
replies, but after a careful study of the Impact Assessment, China believes that the legal basis of 
restricting halogenated flame retardants (HFRs) is still insufficient ，and requests EU to apply the 
restriction of HFRs in D4 Annex II of (EU) 2019/2021 in line with Stockholm Convention on Persistent 
Organic Pollutants  (POPs ). Firstly, the E U lists the regulations on the use of brominated flame 
retardants (BFRs) in the "legal background " of Impact Assessment Annex 15, including REACH, RoHS 
(Restriction of Hazardous Substances), WEEE (Waste Electrical and Electronic Equipment) and the 
WFD (Was te Framework Directive) legislation. It should be noted in particular that the scope of the 
above legislation for BFRs is within the Stockholm Convention, and does not extend to the prohibition 
 
87 For previous statements follow the thread under IMS ID  575 (under dates raised and references) . G/TBT/M/82  
 
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  of all HFRs. In fact, there are over 70 BFRs and only five hav e persistent, bioaccumulative and toxic 
(PBT) property and are listed in Stockholm Convention as POPs. Therefore, we consider that the 
legal basis and scientific basis for the provision of restricting all HFRs in (EU) 2019/2021 is 
insufficient. Secondly, a ccording to the EU's reply at the 82nd TBT meeting, the EU is drafting the 
guidelines based on RoHS thresholds, it is recommended that the EU provide the specific names of 
the restricted HFRs, following the practice of RoHS.  
2.394.   The representative of Brazil  provided the following statement. Brazil supports the concerns 
raised by China with regard to this STC. Our private sector will be particularly affected by the ban 
on the use of HFRs in the enclosure and stand of electronic displays, according to The New Ver sion 
Annex II D, related to "materials efficiency". Such prohibition is not in line with the REACH Regulation 
and the Restriction of Hazardous Substances Directive. The potentially conflicting regulatory 
requirements between those measures and the Eco -design Directive raise questions about 
transparency in regulating these products. We acknowledge the EU concerns with the fact that HFRs 
in enclosures and stands of electronic displays could hinder recycling of WEEE plastics. However, the 
recycling of brominat ed flame retardants, for instance, is being well managed by innovative plastics 
and polymer recyclers. Therefore, Brazil respectfully asks the European Union to consider 
withdrawing such burdensome and trade -restrictive requirements.  
2.395.   In response, the repre sentative of the European Union  provided the following statement. 
Firstly, the legal basis for this amending act is provided by Directive 2009/125/EC of the European 
Parliament and of the Council of 21 October 2009, establishing a framework for the setting  of eco -
design requirements for energy -related products. This empowers the European Commission to set 
eco-design requirements for energy -related products, which account for significant volumes of sales 
and trade in the Union, and which have a significant e nvironmental impact and present significant 
potential for improvement through design in terms of their environmental impact, without entailing 
excessive costs. Unless otherwise specified, the requirements of the Stockholm Convention are "de 
minimis " provis ions, allowing parties to adopt own measures with a higher level of environmental 
ambition. Secondly, the proposed text of the amendments is available for public feedback under 3 
November.88 The specific names of the substances in question are laid down in  Article 4 of "ANNEX 
IV – Amendments to the Annexes to Commission Regulation (EU) No 2019/2021 ". Finally, the 
proposed Eco -design requirement restricting the use of HFRs does not undermine but complements 
the objectives and requirements of the REACH, RoHS,  and WEEE Directives. A wide range of 
supporting facts and figures on the recycling of plastics from televisions and other electronic displays 
can be found in the detailed Impact Assessment carried out prior to the adoption of the initial 
regulatory act.89 
2.1.3.39   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 59290) 
2.396.   The representative of China provided the following statement. China appreciates EU's efforts 
on environmental protection, and I wish to thank the EU for their feedback to our questions, however 
we would still suggest that: firstly, EU clarifies whether washing machines without he ating function 
are included in this regulation. The draft regulation requires that the washing process of household 
washing machines should provide an "ECO 40 -60" washing cycle function, but washing machines 
without heating function are designed without th e function of "ECO 40 -60", which means it cannot 
be tested according to the standard. Secondly, China suggests that EU cancels the requirements for 
spare parts delivery time. China believes that the delivery time for spare parts is a business practice 
and should not be promulgated and implemented in a regulation, moreover, under the situation of 
the COVID -19 pandemic, it is not feasible.  
2.397.   In response, the representative of the European Union  provided the following statement. 
The Eco -design regulation on washing machines and washer dryers (2019/2023) also applies to 
machines without a heating function (see Articles 1 and 2). The definition of the "eco 40 -60" 
programme does not require the wash ing machine to have a heating function and is therefore 
applicable to this type of machine . See Article 2: "eco 40 -60" means the name of the programme 
 
88 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/12471 -Energy -efficiency -
updated -EU-rules-on-ecodesign -and-energy -labelling   
89 https://eur -lex.eu ropa.eu/legal -content/en/TXT/?uri=CELEX:52019SC0354   
90 For previous statements follow the thread under IMS ID  592 (under dates raised and references) . G/TBT/M/82  
 
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  declared by the manufacturer, importer or authorized representative as able to clean normally soiled 
cotton laundry declared to be washable at 40 °C or 60 °C, together in the same washing cycle, and 
to which the eco -design requirements on energy efficiency, washing efficiency, rinsing effectiveness, 
programme duration and water consumption relate". It should be noted therefore that household 
washing machines without a heating function shall be tested as described in the Eco -design 
regulation on washing machines  and washer dryers (2019/2023) and shall comply with all 
requirements of Article 3 of this Regulation . Requirements for spare parts delivery time are essential 
to encourage customers to have their appliances repaired. As indicated in Annex II to the Eco -design 
regulation on washing machines and washer dryers (2019/2023), these requirements are applicable 
as of 1 March 2021. Reparability is an essential element of the circular economy, as recently 
underlined in the Circular Economy Action Plan, a Communication from the European Commission 
released on 11 March 2020. So far, we do not have enough elements at our disposal to analyse a 
potential disruption of the availability of spare parts after 1 March 2021 that might be linked to the 
COVID -19 crisis.  
2.1.3.40   Republic of Korea - Package Recycle Classification Regulation, 
G/TBT/N/KOR/843 , G/TBT/N/KOR/844 , G/TBT/N/KOR/857  G/TBT/N/KOR/857/Add.1 , 
(IMS ID 58891) 
2.398.   The representative of Canada  provided the following  statement. As stated in previous 
Committee meetings92, Canada remains concerned 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 . Canada recognizes and supports Korea's efforts and actions to protect the 
environment, particularly with respect  to the management of waste and recyclable materials. 
However, Canada stresses that Korea has yet to provide a response to its letter of comments sent 
on 22 November 2019 despite its multiple requests to Korea's Enquiry  Point and at the TBT 
Committee. Unde r Article 2.9.4 of the TBT Agreement, Korea should have "[…] discuss these 
comments upon request, […] ", yet Canada's requests remain unanswered. Korea's response would 
have helped Canadian stakeholders to better prepare for the entry into force of the Regu lation earlier 
this year. In its statements of February and May 2020, Korea ensured Members that it would "soon" 
share the final version of this regulation, including the Package Recycling Classification Regulation. 
To date, Canada has yet to receive notification of these documents, and we are seeking an estimate 
of when Korea will be sharing the final version of th ese regulations. Our understanding is that this 
regulation contains many different pieces of legislation: from the Act on the Promotion of Saving 
and Recycling of Resources itself, to side regulations and notifications defining a series of exemption 
(e.g.,  fruit wines, whisky), methods of determination, and standards of packing material. Some of 
these pieces of legislation may not have been communicated to WTO Members, and Canada is of 
the view that interested Parties would benefit from Korea notifying all relevant pieces of legislation 
under the Act on the Promotion of Saving and Recycling of Resources under a single, consolidated 
notification. Canada looks forward to Korea's further engagement on this issue.  
2.399.   The representative of Australia  provided the fol lowing statement. Australia recognizes 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 categorized as "difficult" to recycle.  
2.400.   The representative of the European Union  provided the following statement. The EU strongly 
supports actions taken for the protection of the environment and acknowledges the efforts made by 
the Republic of Korea to facilitate the recycling procedure by encouraging producers to place recycle -
friendly products on the market, but the EU remains concerned about the negative impact that the 
notified measure would have on trade. The EU welcomes the exemption given to glass bottles of 
wine and whisky products from the labelling requirement. However, the EU continues to be 
concerned about the requirements for olive oil bottles. These too require opaque packaging in order 
to avoid sunlight deterioration and preserve the product integrity. Ju stification documents for the 
exemption were provided to the Korean Ministry of Environment in June 2020 however no reply has, 
as yet, been received. The EU would appreciate a positive review of this request and an exemption 
for olive oil bottles, regardle ss of the material used, from its labelling requirements without further 
 
91 For previous statements f ollow the thread under IMS ID  588 (under dates raised and references) . 
92 G/TBT/M/79 , item 2.2.4.23; G/TBT/M/80 , item 2.2.3.44; G/TBT/M/81 , item 1.3.51 . G/TBT/M/82  
 
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  delay. The EU understands that the exemption of a product from the labelling requirement does not 
entail an exemption from the fee and would like the Republic of Korea to confirm this  point and 
explain the criteria used for the two processes. Additionally, the EU is concerned that the process 
for the distribution of the environmental fee to companies that produce "easy to recycle " products 
could provide an unfair advantage to local pro ducers over importers and thus be discriminatory. The 
EU kindly invites Korea to provide further information on the subject.  
2.401.   The representative of Mexico  provided the following statement. Mexico refers to the Sub Act 
on the Promotion of Saving and Recyclin g of Resources, notified by the Republic of Korea in various 
documents: G/TBT/N/KOR/843 , G/TBT/N/KOR/844 , G/TBT/N/KOR/857  and 
G/TBT/N/KOR/857/Add.1 . In addition, in September  2020, two further notifications were published 
in documents G/TBT/N/KOR/918  and G/TBT/N/KOR/919 , both of which had the same title and were 
notified on 22 and 23  September, respectively.  The Republic of Korea has stated that o nly those 
products graded the "lowest" as "difficult to recycle" were obliged to indicate the recyclability class 
on their labels and has exempted certain products from this requirement.  The delegation of Mexico 
has stated that its concern is based on the fact that the 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 determining whether the measure would apply to the bottles 
of tequila.  
2.402.   Furthermore, there is some confusion over the last two documents notified in September 
and how they are related to the Sub Act, as they also refer to the "Draft Partial Amendment to the 
Regulation on the Promotion of Saving and Recycling of Resou rces".  In view of the above, the 
delegation of Mexico requests the delegation of the Republic of Korea to:  Provide clarification on the 
criteria used to determine which bottles would be subject to indication of the wording "difficult to 
recycle" and which would be exempt. If possible, confirm whether bottles of tequila would be covered 
by this regulation, or whether they might be excluded from the labelling obligation, as in the case 
of wine and whisky;  Clarify the relationship between the above six notific ations and their 
implications. Or, failing that, clarify if they concern different draft regulations; and  Share the English 
version of the documents notified on September  2020 in order to facilitate their review and the 
submission of comments during the pu blic consultation period ending on 22 and 23  November  2020, 
respectively. Also, clarify the differences between each of them.  The delegation of Mexico thanks 
the delegation of the Republic of Korea for giving its consideration to this statement and to the 
requests made therein.  
2.403.   The representative of New Zealand  provided the following statement. New Zealand supports 
measures that focus on legitimate objectives, including those that produce positive environmental 
outcomes, such as encouraging recycling and re ducing waste. However, as an exporter of food and 
beverage products, New Zealand remains interested in understanding how Korea's proposed 
measures are no more trade restrictive than necessary. We encourage Korea to consider how 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 parti cular, 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.  
2.404.   In respons e, the representative of the Republic of Korea  provided the following statement. 
Korea appreciates the interest of the Members in Korea's regulation on packaging materials. Korea 
would like to deliver the official response from the regulatory authority. Ex emption from the labelling 
obligation is finalized after review by the "Packaging Materials Review Committee" composed of 
experts in accordance with the "Quality and Structural Standards of Packaging Materials ". Therefore, 
if an olive oil manufacturer or i mporter requests an exemption from labelling of its products, the 
"Packing Materials Review Committee" will decide whether to exempt them by reviewing alternative 
materials and fairness among items. For your information, until now, olive oil manufacturers or 
importers have not officially requested an exemption from the labelling obligation to the "Packaging 
Materials Review Committee " by submitting the specific request form. Also, from 2021, the EPR 
(Extended Producer Responsibility) contributions will be d ifferentiated according to the recycling 
grade of packaging materials. Those who produce or import "difficult to recycle" grade packaging 
materials will be charged an additional 20% of their EPR contribution.  G/TBT/M/82  
 
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  2.405.   On the other hand, those who produce or import "easy to recycle" grade packing materials 
will receive subsidies equal to 50% of their EPR contributions. Differentialization of EPR contributions 
is planned to be applied from items exempted from the duty of labelling (wine, whisky, etc.) and 
PET bottles from 2021, gradually expanding the applied items. On the other hand, these measures 
were discussed and decided by importers, producers, and recyclers participating in EPR, so it is 
difficult to regard them as particularly beneficial to producers in Korea. Korea will continue to consult 
with stakeholders regarding this regulation and share the final version of the Package Recycle 
Classification Regulation. After this committee meeting, Korea will consult with the relevant 
authorities so that we can reply to concerns raised by Canada and other Members which are not 
included in this response.  
2.1.3.41   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (IMS ID 
60293) 
2.406.   The representative of the United States  provided the following statement. The United States 
remains concerned over the trade disruptions caused by Qatar's dairy product regulation, published 
by the Ministry of Public Health in May 2019, which, among other effects, restricts the reconstitution 
of milk and shelf life of cheeses. Qatar adopted this measure without notifying it to the WTO, or 
providing trading partners the opportunity to comment, or providing a reasonable implementation 
period. This measure, in fact, appears to have been issued as a  final measure, given that no 
comments were taken into account, and the measure has caused significant disruptions to trade 
since its implementation on 1 June 2019. Despite many bilateral discussions the United States has 
had with Qatar, US exporters conti nue to be blocked due to the enforcement of this measure, and 
businesses in Qatar have faced shortages of supplies needed for production. Therefore, we request 
Qatar to terminate this measure and revise it so that trade may continue.  
2.407.   The representative 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 ent ered 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 comp liance with these requirements is not feasible 
for certain cheeses and milk products. As consequence, EU products covered by the measure cannot 
be exported to Qatar anymore. The EU is particularly concerned about the stringent restrictions on 
the shelf lif e that disadvantage imported products in comparison to local products, but also about 
certain product characteristics for UHT milk and white cheeses, in particular obligatory addition of 
vitamins to milk and low -fat-only requirement for certain white chees es. These requirements are not 
in line with Codex 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 l egitimate 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 would like to invite 
Qatar to suspend the application of the measure without further delay, align it to t he WTO rules and 
comply with its notification obligations. The EU would like to thank Qatar for bilateral exchanges 
during the past months, which unfortunately have not yet resulted in an effective solution. The EU 
is prepared to continue to work construct ively with Qatar to resolve this important issue.  
2.408.   The representative of Canada  provided the following statement. Canada would like to 
reiterate its concerns with Qatar's new shelf -life requirements for identified milk and cheese products 
established by the  Ministry of Public Health on 30 May 2019. As stated in previous TBT Committee 
Meetings, Canadian exporters of paneer cheese are unable to fulfil contracts with Qatar importers 
due to the overly restrictive shelf -life requirements for paneer cheese. The 50 -55 day ocean transit 
from Canada to Qatar effectively makes it impossible to comply with the new 45 -day shelf -life 
requirements. We remain concerned that these stringent shelf -life requirements effectively 
encourage the domestic or close proximity sourcin g of these products which potentially leads to the 
discriminatory treatment of imported products. 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 wit h the opportunity to comment. Until then, we respectfully request that Qatar suspend 
its implementation.  
 
93 For previous statements follow the thread under IMS ID  602 (under dates raised and references) . G/TBT/M/82  
 
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  2.409.   Subsequent to the TBT Committee held in February 2020, Canada submitted detailed 
questions through Qatar's Enquiry Point on 26 March 2020 to obtain add itional clarifications on the 
measure and to highlight specific concerns. At the last TBT Committee meeting in May 2020, Canada 
reiterated its request for answers. To date, Canada has not received a response. Canada's specific 
questions are as follows: We understand that paneer cheese would meet the definition of "white 
cheese " according to this circular. Is this correct? Could Qatar provide details on how the shelf -life 
requirements were determined? We note that certain cheeses can only be presented in low -fat form 
and that the addition of vitamins to milk is obligatory. Could Qatar please provide details on how 
these requirements were determined? We would also appreciate clarifications on the requirements 
to add vitamins to milk and the low -fat only requir ement for certain white cheeses. Could Qatar 
explain how these requirements were determined and share any relevant information. While we 
recognize that some processes may have been temporarily disrupted due to the current global 
pandemic, we would apprecia te if Qatar could acknowledge receipt 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 further engagement with Qatar.  
2.410.   In response, the representativ e of Qatar  provided the following statement. 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 still following this matter with the competent authorities in Doha, despite the lockdown 
imposed by the COVID -19 pandemic.  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 Government 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 t he 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 legi timate 
objective of protecting consumers. In this respect, we would like to emphasize that product -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 today with our 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.  
2.1.3.42   Republic of Korea - Ballast Water Management Act (IMS ID 60694) 
2.411.   The representative of the European Union  provided the following statement. The EU would 
like to recall its concerns  raised in previous Committees concerning the Republic of Korea's 
requirements on the certification of ballast water treatment systems (BWTS) manufactured by EU 
companies for vessels registered under the Korean flag, specifically regarding the time needed to 
review tests that were already performed. The EU would like to thank the Republic of Korea for 
facilitating a reduction in the fee request but would also like to underline the importance of a prompt 
issuance of the certificates for European companies, w hich are currently under review.  
2.412.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea appreciates the interest of EU member States in Korea's Ballast Water Management Act. Korea 
would like to deliver the official  response from the regulatory authority. As explained to the last WTO 
and FTA, Korea's Ballast Water Management Act has already stipulated that foreign systems may be 
equal to Korean products in the conditions for type approval. So, Korea would like to als o explain 
that Korea has no technical and institutional barriers to foreign system in the procedure of type 
approval of Ballast Water Management System. Furthermore, Korea has reasonably improved the 
cost and time required for type approval in March this y ear so that domestic and foreign companies 
can obtain type approval more quickly. However, in the case of a European company that is 
undergoing the type approval process in Korea, the process is considered to be pending because the 
documents required for t he type approval review are not supplemented. Korea would like to inform 
the EU once again that Korea is providing equal treatment to domestic and foreign companies 
without any technical or institutional barriers on the type approval of Ballast Water Manag ement 
System. In addition, any comments or enquiry will be received by Ministry of Oceans and Fisheries, 
the competent authority of Korea.  
 
94 For previous statements follow the thread under IMS ID  606 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.43   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labellin g 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/178/Add.11 , G/TBT/N/MEX/178/Add.13 , G/TBT/N/MEX/178/Add.9 , 
G/TBT/N/MEX/468 , G/TBT/GEN/302  (IMS ID 60895) 
2.413.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
support the trade concern raised by the European Union and the United States regarding Mexico's 
proposed front -of-pack nutrition labelling for food products. In recent years, Costa Rica has very 
much believed in, and defended, the importance of the work carried out within the Codex 
Alimentarius framework, and has given equal importance 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 
Alimentarius is currently developing working materials on front -of-pack nutrition labelling, Costa 
Rica wishes to request once again t hat the Mexican delegation clarify its position regarding the work 
carried out in the Codex in this area. With regard to the content of the measure, and bearing in mind 
that the classification parameters according to which a product is considered to contai n excessive 
calories, sugar, saturated fats, trans fats or sodium are not Codex -based, we reiterate the request 
made to the Mexican delegation at this Committee's previous meeting, to indicate the scientific basis 
or international reference standard used t o define the key parameters for Mexico's classification and 
to provide relevant justification for the use of the front -of-pack warning sign as supplementary 
nutrition information.  
2.414.   Turning to the consumption by children of products containing added caffeine  or sugar 
substitutes, Costa Rica requests the delegation of Mexico to refer to either the international reference 
standard used or the risk analysis establishing 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 established in Articles 
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 restrictions or burdens, without prejudice to the power that Members have to adopt them 
if considered necessary, constitutes a challenge that hampers glo bal economic recovery efforts, 
especially in developing countries that are reliant on international trade, such as Costa Rica. In light 
of the foregoing, we would be grateful if the Mexican delegation could inform us about the progress 
of this draft amendm ent. 
2.415.   The representative of the United States  provided the following statement. The United States 
supports Mexico's public health objective of reducing diet -related NCDs and appreciates Mexico's 
notification of NOM -051, "General Labelling Specifications for Pre -Packaged Foods and Non -Alcoholic 
Drinks  – Commercial and Health Information. " The United States continues to be concerned that the 
revised regulation, intended to address public health, may be more trade restrictive than necessary 
to meet Mexico's legitimate health objectives, may not be based on robust scientific evidence, go 
beyond international standards and may contribute to consumer confusion. Unfortunately, the 
concerns we raised about the short time allowed for compliance with these requirements, only six 
months after the final regulation  was published, have now materialized. Delays are growing with 
trucks backed up along the border due to the significant number of products that unexpectedly must 
be relabelled and verified. On 1 October, the Government of Mexico published changes to the Ge neral 
Rule for Foreign Trade regarding compliance with technical regulations (NOMs) requiring product 
labelling. The resolution went into effect on the same day. The Mexican customs authority SAT is 
enforcing the resolution to require that raw materials, b ulk products and, in general, products for 
use in further industrial or services activities, including food service products, are no longer exempt 
from the labelling requirements of 14 NOMs. This includes enforcement of the new front -of-
packaging labelling  included in NOM -051 that entered into force the same day. The US Government 
and US exporters did not expect food service products would need to comply with NOM -051's 
labelling requirements intended for the final consumer.  
2.416.   Inclusion of food service product s impacts more than USD 1 billion worth  of US exports that 
were not understood to be in the scope of NOM -051. The dairy industry has estimated that up to 
USD 750,000  worth of bulk cheese are requiring relabelling every day, while our potato industry 
estima ted costs at USD 500,000 for relabelling in the first five days the measure was in effect. We 
 
95 For previous statements follow the t hread under IMS ID  608 (under dates raised and references) . G/TBT/M/82  
 
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  urge Mexico to clarify that food service products are exempt from compliance with NOM -051 and 
request that it immediately honour the enforcement delay until 1 Dec ember 2020, a grace period 
already notified to the WTO while trading partners work through clarifications on compliance for food 
service and other products. While Mexico has stated that a clarification is in process, and that the 
scope of NOM -051 has not c hanged with food service products outside the scope of the measure, its 
clarification has yet to be published. As already mentioned, US industries already hard hit by the 
complications of the COVID -19 pandemic are bearing additional daily costs that can be  avoided. We 
thank Mexico for the productive discussions so far and its willingness to work with the United States 
to resolve concerns, however, we urge immediate action. Can Mexico confirm when it will issue the 
clarification related to enforcement of its  technical regulations? The US said: We have received some 
information from Mexico that could alleviate some of our concerns, but we are not completely done 
translating and analysing the documents.  
2.417.   The representative of the European Union  provided the foll owing statement. The European 
Union would like to thank Mexico for the opportunity to send written comments on the notification 
G/TBT/N/MEX/178/Add.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 and 
for the reply to these comments. First, the European Union would like to underline that it supports 
and shares the objective of Mexico to inform the consumers clearly and truthfully of the content of 
critical nutrie nts presenting health risks in excessive consumption. At the same time, the EU notes 
that it is necessary to guarantee an efficient implementation of the new rules to prevent them 
becoming an obstacle to trade. The phase one of implementation of the NOM -051 started on 1 
October 2020. Unfortunately, the worries of the EU food producers that the very short transitional 
period provided for in NOM -051 would not be sufficient to adapt their labelling practices to the new 
requirements have now materialized. The E U is receiving numerous complaints from EU importers 
to Mexico concerning very serious difficulties with implementation of the revised labelling obligations 
in NOM -051, resulting in blockages of EU containers in customs.  
2.418.   To minimize negative impact on trad e, the European Union invites Mexico to take urgent 
steps to guarantee efficient custom clearance of the blocked containers. In parallel, the competent 
Mexican authorities are invited to provide the custom officials and importers with clear guidance on 
implementation of the new labelling rules. The European Union would like to ask in particular the 
following questions: The new labelling obligations are already being enforced before custom 
clearance, despite the two -months grace period given by "Acuerdo Inte rinstitucional " of July 2020 
(ending 30 November 2020). Can Mexico explain why the two -months grace period is not being 
respected for imported products? The EU appreciates that stickers can be used for compliance with 
the labelling obligations, however thi s is only temporary (until 31 March 2020). We would like to 
invite Mexico to provide for a permanent possibility to use adhesive labels to comply with all the 
relevant obligations on food labelling. The EU would like to ask for a clarification with regard to the 
"labelling compliance certificates ", which must be obtained from an Authorized Verification Unit 
(AVU) and must be presented to customs upon arrival of the goods, if the importer does not select 
neither one of the other two options available to prov e labelling compliance. So far, companies report 
experiencing unusual delays in obtaining those certificates. Could Mexico explain how will efficient 
issuance of these certificates be guaranteed to avoid delays in customs?  
2.419.   The European Union would like to thank Mexico for information about the document 
"Criterios de aplicacion de normas oficiales Mexicanas – insumos no destinados al consumidor final ", 
issued on 26 October 2020, which provides for exemptions from labelling obligations under NOM -
051 for food products not destined for final consumer. The European Union appreciates this 
exemption, will analyse the document and revert to Mexico with further questions, if needed. Finally, 
the European Union would like to thank Mexico for the useful bilateral discu ssion and appreciates 
that some clarifications for importers were provided on the website Servicio Nacional de Información 
de Comercio Exterior (SNICE). Mexico informed that its competent authorities are working on a 
guidance documents regarding implementa tion of the new labelling requirements under NOM -051. 
Can Mexico specify whether there will be any further guidance documents apart from those already 
published? The EU said: We are in a similar position to the United States because we recently 
received so me useful information from Mexico.  
2.420.   The representative of Guatemala  provided the following statement. The new Mexican Official 
Standard (NOM) on the labelling of pre -packaged food and non -alcoholic beverages 
(NOM -051-SCFI/SSA1 -2010), which entered into forc e on 1  October  2020, seeks to establish the 
commercial and health information that must be displayed on the labels of pre -packaged domestic G/TBT/M/82  
 
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  or foreign products marketed in national territory, determine the characteristics of such information 
and establish a system of front -of-package labelling for the general population, in order to provide 
consumers with clear and accurate information on the presence of critical nutrients that pose a 
health risk if consumed in excess.  We reiterate our appreciation of Mexic o's efforts to protect people's 
health and provide consumer information and thank Mexico for keeping Members informed at each 
stage of the notification process for NOM -051-SCFI/SSA1 -2010.  
2.421.   Regarding NOM -051-SCFI/SSA1 -2010: General specifications for the lab elling of 
pre-packaged food and non -alcoholic beverages, which entered into force on 1  October  2020, we 
should point out once again that, in accordance with Article 2.2 of the Agreement on Technical 
Barriers to Trade, measures applied by Mexico must not be  more trade -restrictive than necessary . 
For 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 refer, above all, to the points raised at the last meeting 
in May, regarding the discontinuation of the use of adhesive labels in order to  ensure compliance 
with the requirements set out in NOM -051-SCFI/SSA1 -2010.  In this regard, we wish to refer to 
notifications G/TBT/N/MEX/178/Add.13  of 10  July 2020 and G/TBT/GEN/302  of 19  October  2020, 
which provide information on the publication of the Amendment to the Agreement under which the 
Ministry of the Economy issues general rules and criteria in respect of foreign trade . Both 
notifications indicate that until 31  March  2021 goods with adhesive transfers or stickers affixed to 
product labels may be presented for customs clearance provided that they comply with the provisions 
of NOM -051-SCFI/SSA1 -2010.  
2.422.   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 supplementary 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 and accurately reflect that in the original label".  With the provision established in the current 
Standard, Mexico is departing from the international reference standard and establishing an 
unnecessary obstacl e to international trade . In this regard, at the national level, Mexican food 
products sent to the Guatemalan market are able to comply with the labelling requirements 
established by Central American regulations through the use of supplementary adhesive la bels, 
instead of being required to have permanent labels affixed in the country of origin exclusively for 
the Guatemalan market . This measure facilitates trade and is proportionate to the level of protection 
sought, and we therefore request reciprocal trea tment.  
2.423.   Following on from its remarks at the last meeting in May, Guatemala also wishes to make 
the following comments:  With regard to warnings concerning the use of sweeteners, the standards 
developed within the framework of the Codex Alimentarius – includ ing Codex Stan 192 -1995, 
General Standard for Food  Additives, 2019 revision - are based on solid scientific data . The Joint 
FAO/WHO Expert Committee on Food Additives (JECFA) is an independent international scientific 
committee that conducts risk assessmen ts and advises on exposure assessment . It is therefore 
considered that the information provided to consumers in terms of warnings concerning the use of 
sweeteners aimed at children over three years of age is not scientifically based.  The General 
Standard f or the Labelling of Prepackaged Foods CXS  1-1985, revised in 2018, clearly establishes 
that pre -packaged food shall not be described or presented on any label or in any labelling in a 
manner that is false, misleading or deceptive or is likely to create an erroneous impression for 
consumers regarding its character in any respect . We therefore reiterate that in the new regulations 
on labelling, the reference to an imitation product is inconsistent with the Codex  Alimentarius, when 
the pre -packaged food produc t is not based on compliance with existing Mexican standards . 
Furthermore, we believe that establishing typographical characteristics for the denomination 
"imitation" constitutes an unnecessary restriction on international trade.  
2.424.   The limits set for nutrien ts on labels reflect the thresholds established 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 charac teristic of a specific food or beverage.  The restriction on 
the use of children's characters limits the use and enjoyment of an intellectual or industrial property G/TBT/M/82  
 
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  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 on Trade -Related Aspects of Intellectual Property Rights 
(TRIPS).  We reiterate that some provisions of the e xisting regulations depart from the content of 
the Codex  Alimentarius, which has the solid backing of the relevant scientific bodies . The aim of the 
Codex  Alimentarius is to ensure international harmonization and the elimination of trade barriers.  
2.425.   The repr esentative of Colombia  provided the following statement. Colombia supports 
Mexico's public health objective of reducing diet -related non -communicable diseases . However, our 
country wishes to support the trade concern raised by the European Union and Costa Rica on the 
amendment to Mexican Official Standard NOM-051-SCFI/SSA1 -2010, "General specifications for the 
labelling of pre -packaged food and non -alcoholic beverages  - Commercial and health information" , 
which  establishes a front -of-pack labelling scheme f or pre-packaged food and non -alcoholic 
beverages cont aining sugars, fats or sodium . In this regard, our industry has expressed concern 
about the implementation of the measure adopted by Mexico, not least given that this technical 
regulation may be more tra de restrictive than necessary to fulfil public health objectives, as it does 
not appear to be based on relevant international standards or sound scientific evidence, running 
contrary to Article 2.4 of  the Agreement on Technical Barriers to Trade TBT/WTO ( "TBT Agreement "), 
which provides that : "Where technical regulations are required and relevant international standards 
exist or their completion is imminent, Members shall use them, or the relevant part s of them, as a 
basis for their technical regulations ". However, this measure  stigmatizes  foods developed by the 
industry  based on non -technical  classifications and criteria, because they refer to systems that are 
not clear or precise, causing  confusion am ong consumers . 
2.426.   In view of the above, we consider it important that such measures use as a benchmark  the 
standards issued by the Codex Alimentarius to ensure that they are based on scientific and technical 
evidence, or on other technical or scientific evide nce, as the nutrient profiles proposed in the 
measure are being called into question due to their lack of technical rigour . This is because the 
measure means applying the recommendations made by experts on the total diet to particular foods, 
ignoring the f act that many factors contribute to overweight and obesity, with bad eating habits and 
a sedentary lifestyle, total food intake or the quantity and frequency of its consumption being 
relevant factors . Therefore, when addressing such problems , account shoul d be taken of the intrinsic 
levels that some foods contain and which are not the result of an industrial process.  Colombia 
considers that the measure is more restrictive than necessary  and may become an unnecessary 
obstacle to trade, violating Article 2.2 of the TBT Agreement , which 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 obstacles to international trade . For this purpose, technical regul ations 
shall not be more trade -restrictive than necessary to fulfil a legitimate objective ".  
2.427.   Finally, we consider that the measure could  also have shortcomings  from the point of view  
of competition, as it could limit the number of enterprises in  the marke t, inhibit the ability of one or 
more enterprises to compete , limit the options and information available to consumers  and reduce 
incentives for enterprises  to innovate and compete . The design of the nutrient profiles of the Mexican 
regulation  discourages the reformulation of products because, as they are based on a percentage in 
relation to their total energy content, there will always be the requirement  to include warning labels , 
despite industry innovation efforts . It is impossible to change the composition of some foods, owing 
to their nature and characteristics.  In light of the above , Colombia requests Mexico to review the 
regulation , taking into account the comments submitted by C olombia during the international public 
consultation phase . I would  also like to request that the industry be granted a longer period of time 
to make  the adjustments in the production process that are required under the regulation , with a 
minimum of two ye ars. 
2.428.   The representative of Paraguay  provided the following statement. Paraguay supports 
Mexico's objective of protecting public health and considers nutritional information provided to the 
consumer to be an appropriate strategy. However, Paraguay shares th e concern of other countries 
over the mandatory declaration of added sugar, which is not provided for under Codex guidelines. 
Also, it concerns Paraguay that no analytical method can differentiate between total sugar and sugar 
added to a food, thus complic ating taxation, as it would depend on the information provided by 
industry.  The nutritional labelling's lack of harmonization with international guidelines could impede 
trade between countries.  G/TBT/M/82  
 
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  2.429.   The representative of El Salvador  provided the following state ment. El Salvador once again 
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 specifications 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 number of comments on the am endment 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 proof of a 
direct link betw een 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 s edentariness, 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.  
2.430.   El Salvador recognizes that another of Mexico's objectives is to provide consumers wi th 
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 necessarily 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 scientific 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 internation al 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.  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.  
2.431.   The representative of Switzerland  provided the following statement. Switzerland would like 
to reiterate its concerns regarding the amendment of the Mexican Official Standard NOM -051-
SCFI/SSA1 -2010 "General specifications for the labelling of pre -packaged food and non -alcoholic 
beverages - Commercial and health information ". The first phase of NOM -051 entered into force on 
1 October. The rest of the provisions are foreseen to enter into force in April 2021. First, and despite 
Mexico's earlier efforts to explain that the amendment is in line  with international guidelines, we are 
unconvinced that NOM -051 is in line with international guidelines since the Codex Guidelines on 
Nutrition Labelling do not foresee the use of warning labels as proposed by the amendment. The 
Codex Guidelines on Nutrit ion Labelling further state that the information contained in the nutrient 
declaration "should not lead consumers to believe that there is exact quantitative knowledge of what 
individuals should eat in order to maintain health, but rather to convey an unde rstanding of the 
quantity of nutrients contained in the product". We also note that no explanation has been given 
concerning the motivation behind choosing a label with warnings, such as "exceso en ". As mentioned 
previously, consumers may come to believe t hat these foods should be avoided altogether, while 
they can be part of a balanced diet.  
2.432.   Second, we call on the Mexican authorities to consider extending the cut -off date beyond 
the 30 November 2020 for food and non -alcoholic beverages produced or imported  before the 
1 October 2020. On this date, the first phase of NOM -051 entered into force. Relabelling food and 
non-alcoholic beverages with a shelf life of 12 or more months would come at a considerable cost to 
businesses, when more cost -efficient options a re possible. Third, we have received conflicting reports 
that raw materials fall under the scope of, and need to comply with, NOM -051. Other reports suggest 
that this is in fact not the case. Switzerland therefore seeks clarifications from the Mexican 
authorities whether raw materials are excluded from the application of NOM -051. In light of these 
comments, Switzerland encourages Mexico to review the amendment of the Mexican Official 
Standard NOM -051-SCFI/SSA1 -2010 in order to ensure an adequate supply of f ood and beverages 
to the Mexican market in particular during the COVID -19 pandemic.  G/TBT/M/82  
 
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  2.433.   In response, the representative of Mexico  provided the following statement. The delegation 
of Mexico thanks Costa Rica, the United States and the European Union for sharing  their 
observations, on which it has the following comments:  It is possible to carry out labelling in the 
country, in private homes or general bonded warehouses; the details of these procedures are 
described in section  6, subsections  II and  III, of the ame ndment to the NOM Annex.  As for the 
two-month grace period, this is only applicable to products that are already warehoused or at the 
final point of sale to the consumer  in order to facilitate inventory turnover.  Regarding the use of 
stickers or adhesive m aterials, it is important to bear in mind that, on 1  October  2020, only the 
front-of-pack labelling system (stamps and warnings) entered into force. In order to facilitate 
implementation for domestic producers and importers, the labelling currently employe d for 
marketing purposes may continue, with stamps and warnings being affixed if applicable, using 
stickers or adhesive materials. This will be possible until 31  March  2021.  Due to the entry into force 
on 1 April 2021 of all the changes relating to commerc ial and health information that should appear 
on the labels of products subject to NOM -051, the use of stickers or adhesive materials is no longer 
permitted, as there will be a complete change in labelling. However, it will be possible for imported 
product s to continue to use adhesive materials for labelling to comply with all the changes in 
commercial and health information set out in NOM -051. It will also be possible to comply before 
1 April 2021.  
2.434.   In other words, in accordance with the provisions of the a greement published in the Official 
Journal on 10  July 2020, importers will be able to continue to use adhesive materials, but no longer 
only to comply with the requirements of the front -of-pack labelling system (stamps and warnings); 
rather, it will be to comply with all commercial and health information requirements. This benefit 
has no cut -off date. As an example to clarify the situation, importers may use adhesive materials to 
cover all of the current label or label of origin (if they so wish), to cover all that is prohibited under 
NOM-051 (cartoon characters, for instance) and include all commercial and health requirements (for 
instance, octagon symbols, warnings, nutritional information).  In short, from 1  April 2021, all 
products (domestic and imported)  that are marketed to the end consumer in the United Mexican 
States should meet all the requirements provided for in NOM -051. In the case of importers, they will 
be able to use adhesive materials to cover the label of origin to comply with all provisions o f the 
applicable technical regulations . 
2.435.   As regards the request for a certificate of compliance granted by an inspection unit, the 
certificate is conditional on opting for labelling in the country, be that in a private home or in a 
general bonded warehouse.  However, if the option of bringing the label from the country of origin is 
taken up, then the certificate is not necessary, nor is it necessary to use the services of an inspection 
unit. More detailed information on this can be found in the first paragrap h of section 6 and 
subsections  II and  III of the amendment to the NOM Annex.  Information on verification units to 
assess NOM -051 can be found in the following link.96 As previously indicated by Mexico and some 
Committee Members in their statements, discuss ions are taking place in the Codex Alimentarius 
framework and there is currently no international reference standard that may be used as a basis 
for establishing front -of-pack labelling.  Regarding Mexico's position concerning the work under way 
in that for um, we refer Members to the response given during the written procedure, which states 
that, during the 45th Session of the Codex Alimentarius Committee on Food Labelling, the delegation 
of Mexico expressed its support for work on the paper on " criteria for  the definition of 'high in' 
nutritional descriptors for fats, sugar and sodium".  Lastly, the relevant authorities of the Government 
of Mexico worked on the issuance of criteria that will clarify any doubts concerning the application 
of NOM -051, on goods s uch as "in bulk", "raw material" and "end consumer", which have been 
published and are available in the Integrated System for Standards and Conformity Assessment 
(SINEC), in the section on relevant documents . 
2.1.3.44   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 , G/TBT/USA/1581/Add.1  (IMS ID 
61097) 
2.436.   The representative of the European Union  provided the following statement. The European  
Union acknowledges the bilateral dialogue held with the United States, leading to the notification, in 
accordance with the WTO TBT Agreement, of the State of New York Act to amend the environmental 
 
96 https://www.snice.gob.mx/~oracle/SNICE_DOCS/uvasnoms -noms_20201002 -20201002.xlsx  
97 For previous statements follow the thread under IMS ID  610 (under dates raised and references) . G/TBT/M/82  
 
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  conservati on law, in relation to regulation of toxic chemicals in children's products. The European 
Union welcomes initiatives that increase the knowledge about hazardous chemicals in products 
targeted to consumers, and in particular to vulnerable groups, like child ren. However, the European 
Union would like to reiterate its concerns as 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. In particular, the 
law includes a reporting requirement for the presence of any intentionally added c hemicals identified 
as either a chemical of concern or a high -priority chemical by the Department of Environment and 
Conservation.  
2.437.   In this context, the European Union considers necessary that any future proposal for the 
listing of chemicals of concern, hig h-priority chemicals or prohibited chemicals by the State of New 
York should be notified in accordance with the WTO TBT Agreement, so as to allow WTO Members 
to comment on the proposed listing within a 60 -day comment period. Following the bilateral we had 
with the United States last week, the European Union understands that the State of New York is 
aligning with other US State approaches and welcomes this effort. As mentioned in our written 
statement uploaded in eAgenda, the EU still has a few remaining con cerns, both on procedural 
issues, and substance. The European Union believes that the remaining concerns should be clarified 
in the act or at least that the Children Product Safety Council should provide guidance on the notions 
of trace contaminants and pr actical quantification limits in order to ensure clarity and predictability 
in the implementation of the measure. Finally the EU would like to thank the US for the further 
information provided during the bilateral and is keen to continue this dialogue.  
2.438.   The representative of China  provided the following statement. China appreciates the efforts 
made by the United States in protecting lives and health of children. However, China would like to 
ask the US to clarify four points: the first is to further clarify t he relationship between this regulation 
and the federal and state regulations that have been implemented, as well as the participation 
procedures of stakeholders, so as to avoid complicating market access procedures; the second is to 
clarify the criteria i n defining priority and list of banned chemicals; the third is to provide a reasonable 
transition period for the industry to adapt to the launch of new chemicals or to annually review  and 
update such lists; the fourth is about the qualification and measure ment methods or guidelines of 
"trace pollutants ". 
2.439.   In response, the representative of the United States  provided the following statement. The 
bill at issue, "An act to amend the environmental conservation law, in relation to regulation of toxic 
chemicals in children's products, " was signed into law on 7 February. The law adopted a new Title 9 
in Article 37 of New York's Environmental Conversation Law titled, "Toxic Chemicals in Children's 
Products. " New York State amended Title 9 of Article 37 on  April 3 as Chapter 55 of the Laws of 
2020. The enacted language may be found in S.7505 -B/A.9505 -B as Part XX, Subpart AA. The 
amended law is now in effect. The amendments included substantial changes in part to address 
concerns raised by stakeholders. Thi s state -level measure is now more similar to Washington and 
Vermont measures regulating chemical disclosure. The text of the final bill can be found in 
G/TBT/N/USA/1581/Add.1 , notified to this Committee on 26 October 2020. The revised law 
exempted additional items fro m the definition of children's product subject to the measure, 
narrowing the scope. The law does not apply to manufacturers that employ five or fewer people and 
are independently owned and operated or to used children's products, and it also exempts retail ers 
in most circumstances.  
2.440.   The law sets a process for determining a "chemical of concern " based on hazard, clearly 
defines trace contaminants, and provides that the Department has two years from the effective date 
to promulgate a list of chemicals of conce rn. In addition to requiring the list of chemicals of concern, 
the law identifies specific high -priority chemicals and directs the Department to periodically review 
and add to that list. The law requires that manufacturers report to New York the use of che micals 
on either list at or above PQLs in children's products, and further requires notice to retailers of the 
use of a high -priority chemical in a children's product. Manufacturers may request a waiver of the 
reporting requirements for one or more uses of  a high -priority chemical. The law designated Tris 
phosphate; Benzene; Mercury; Asbestos; Arsenic; Cadmium (other than toy coatings); and 
organohalogen flame retardants in upholstered bedding and furniture as high -priority chemicals. The 
law authorizes the  Department to ban chemicals on the list. In addition, effective 1 January 2023, 
the law prohibits the distribution or sale of children's products in which tris phosphate, benzene or 
asbestos is intentionally added. This prohibition does not apply to enclo sed batteries and enclosed G/TBT/M/82  
 
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  electronic components; trace contaminants; and inaccessible components of a children's product 
that during reasonable, foreseeable use and abuse of the product would not come into direct contact 
with a child's skin or mouth. The Department may request a manufacturer to provide a statement 
of compliance with this prohibition. The law additionally establishes a children's product safety 
council to make recommendations to the Department on chemicals that should be listed as high -
priority chemicals and chemicals that should be prohibited from use in children's products. Any 
further changes to the law would require legislation by the New York State Legislature.  
2.1.3.45   Kingdom of Saudi Arabia – Electrical Clothes Washing Machines – Energy and 
Water performance Requirements and labelling (IMS ID 61998) 
2.441.   The representative of Mexico  provided the following statement. The delegation of Mexico 
reiterates the views it expressed during the written procedure of this Committee held in May  2020 
concerning the amendment to technical regulation SASO  2885/2018 of the Kingdom of Saudi Arabia. 
We thank the delegation of Saudi Arabia for its openness to providing information on this measure. 
However, Mexico's concerns remain. The amendments to the SASO technical regulation would 
preclude the importation of washing machines from Mexico, which could contravene Article  2.2 of 
the WTO TBT Agreement by introducing a measure that is more trade restrictive than necessary in 
view of the objective pursued.  In previous comm ents, Mexico has questioned the proportionality of 
the measure in relation to the objective pursued. It has also requested that information be shared 
to better understand the issues that brought about such changes to the regulation.  Furthermore, 
the Mexica n delegation reiterates the importance of implementing the commitments of the TBT 
Agreement on transparency in and conformity with international standards.   
2.442.   In view of the above, the delegation of Mexico requests the delegation of Saudi Arabia to:  
Reconsid er the amendments made to technical regulation SASO  2885/2018 to avoid unjustified 
barriers to trade; and  Establish a channel of communication through which the concerns of the 
Government of Mexico can be discussed.  We are aware that a grace period has bee n granted, which 
expires at the end of November of this year. What is expected to happen when this grace period 
comes to an end?  We request information on the status of the notification of the amendments to the 
technical regulation to this Committee, and o n how to allow for a period of public consultation for 
submitting comments on the measure in question.  The delegation of Mexico thanks the delegation 
of the Kingdom of Saudi Arabia for giving its consideration to this statement and to the requests 
made the rein. 
2.443.   The representative of the United States  provided the following statement. The United States  
supports the statement of Mexico on this concern.  
2.444.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement . As a contin uation of the Kingdom's efforts  to create fair competition between 
manufacturers, protect consumers and raise energy efficiency in the Kingdom, we confirm that the 
clarifying circular issued is just an explanation and relaxation of what was stipulated in the Technical 
Regulations SASO 2 885/2018 in Annex A.2, which was issued based on the cases discovered as a 
result of consumer complaints. This circular was issued to clarify the technical requirements for 
temperatures, which are included in Annex A.2 for manufacturers and laboratories. I t seems from 
the calculation example provided within the TBT issue, that there is a confusion from the 
manufacturer side about the temperatures and the water quantities by changing the total water used 
(full load/partial). SASO always opens the door to lis ten to all concerned parties therefore SASO 
welcomes a direct communication channel with the concerned manufacturer to explain this issue.  
2.1.3.46   Mongolia - Mandatory Requirement for Enrichment of Agricultural Products with 
Vitamins (IMS ID 61699) 
2.445.   The representat ive of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statements made during the previous meetings of the Committee on TBT 
and the Council for Trade in Goods regarding the requirements  on the mandatory fortif ication of 
wheat flour applied in Mongolia. According to the information provided by Mongolia, the standard for 
wheat flour enrichment, which defines the complex of vitamins and mineral compounds for the 
product, was adopted in accordance with World Health  Organization recommendation about food 
 
98 For previous statements follow the thread under IMS ID  619 (under dates raised a nd references) . 
99 For previous statements follow the thread under IMS ID  616 (under dates raised and references) . G/TBT/M/82  
 
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  nutrition. In light of this the Russian Federation would like to request Mongolia to clarify the reasons 
why the dosage of vitamins as well as the respective measurement units used in Mongolian standard 
differ from t he WHO recommendations. The Russian Federation would like to highlight its concern 
with respect to capability of national producers of wheat flour to follow the fortification requirements. 
The fact that Mongolian producers have the right to sell their un -labelled non -enriched wheat 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.  
2.446.   We would like to request information about the list of ac credited laboratories which examine 
and perform certification tests of the enriched products. We also request further information about 
the certification procedure of the fortified product in Mongolia as per our bilateral request that was 
sent previously. The Russian Federation would also like to express its concern about the lack of 
provided  reasonable period between publication of new requirements for wheat flour fortification 
(both the mandatory standard and the rules for production, storage, transportat ion and labelling 
requirements) and their entry into force. The timeframe for producers and exporters of wheat flour 
to adapt their products and production methods to new requirements was just one day, which made 
impossible to follow this technical regulat ion from the day it entered into force. Therefore, Mongolia 
acted inconsistently with its obligations under Articles 2.9, 2.11 and 2.12 of the TBT Agreement by 
failing to make the regulation publicly available and provide reasonable timeframe for adaptatio n 
and comments. The Russian Federation expects Mongolia to take promptly all necessary steps to 
bring its measures in compliance with WTO provisions and is looking forward to getting further 
clarifications regarding the issues raised in our statement today . We urge Mongolia to intensify 
bilateral dialogue on these issues.  
2.447.   In response, the representative of Mongolia  provided the following statement. We will 
forward the statement to the capital and will revert with a reply to the issues raised. We would like 
to reiterate that the import quotas on wheat flour were removed since the beginning of this year. In 
this relation, we would like to refer to our statements given at the TBT Committee meeting of 
February 2020, as well as the meetings of the Committee on Tr ade in Goods (CTG) in June 2020, 
the Committee on Agriculture in July and September 2020, the Committee on Market  Access in June 
2020. With regard to bilateral request, the replies are about to be submitted. It involved coordination 
of various agencies. We  thank the Russian Federation for kind understanding.  
2.1.3.47   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program (IMS ID 615100) 
2.448.   The representative of the European Union  provided the following statement. The Europe an 
Union remains concerned by the difficulties related to the implementation of the electronic 
certification system Saleem through the web -portal Saber that was recently launched by the 
Kingdom of Saudi Arabia. While the European Union would like to thank Saudi Arabia for engaging 
constructively in bilateral talks on the issues raised, these difficulties still have a major negative 
impact on the imports of several products from the European Union to Saudi 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 in particular in view of the COVID -19 outbreak and the global crisis this 
has created. Notably, EU toy manufacturers continue to report difficulties related to obtaining a GCC 
Conformity Tracking Symbol (so -called GCTS) from NBs au thorized by SASO. In particular, EU 
exporters report that such NBs continue to find new ways to increase costs when carrying out 
conformity assessment procedures. However, the EU would like to commend that from our 
understanding new guidelines for the GCTS  have been released, which will simplify the requirements 
of the new system in order to address in particular the specificities of the toy sector. This includes 
allowing for an efficient system of grouping several stock -keeping units (SKUs) with similar 
characteristics under one GCTS, as well as a possibility of adding new products to an existing GCTS 
covering a similar group.  
2.449.   The EU will monitor the implementation of this new guidance closely and further requests 
that documentation during the GCTS certific ation process should be kept to the minimum necessary 
to assess the safety of products. In this regard, no additional certificates of conformity, such as 
product certification of conformity (PCOC), should be requested, when the GCTS had already been 
 
100 For previous statements follow the thread under IMS ID  615 (under dates raised and references) . G/TBT/M/82  
 
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  issued . The registration and renewal costs for GCTS should also be minimized 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. As previously r eported, 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 t heir majority considered low -risk. EU companies are still facing long delays with 
regard to their on -going applications for the Saudi Quality Mark, reporting difficulties related to 
communication with authorized conformity assessment bodies and with the Sa udi administration, 
unclear requirements regarding documents to be submitted, disproportionate fees, transparency 
issues where information for producers based outside Saudi Arabia is made available only in the 
Arabic language as well as different treatment  between exporters and domestic manufacturers in 
Saudi Arabia in terms of conformity assessment for the products at stake. Moreover, EU exporters 
are reporting a limited availability of accredited certification bodies.  
2.450.   In this regard, the EU side has sent a set of questions to Saudi Arabia on this topic on 
9 September 2020 and would welcome close cooperation of Saudi Arabia's authorities in this respect. 
In addition, the EU would again like to ask Saudi Arabia for a clarification whether it would be 
obligat ory 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 conclusion, 
the European Union would like to kindly invite the Kingdom of Sa udi 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 and thanks again to Saudi 
Arabia for the bilate rals we had last week.  
2.451.   The representative of Switzerland  provided the following statement. Switzerland would like 
to reiterate its concerns over the implementation of the Saleem Product Safety Programme on the 
Saber Conformity Assessment Online Platform. O ur industry, in particular the textiles and machinery 
sector, reports persisting  problems with the implementation of the registration and certification 
process. The registration and certification process remains costly, burdensome and time consuming 
for ou r exporters. In particular for companies exporting quality products in small quantities, the 
registration and certification process leads to disproportionate costs and documentation 
requirements which may be prohibitive to enter the market. According to th e Saber Conformity 
Assessment Online Platform each product that is allocated to another six -digit customs tariff number 
requires a new certification process. In certain cases, the certification and registration costs 
amounted up to 40% of the order volume.  Moreover, the certificates of conformity are valid only for 
12 months, which creates additional burdens to the industry. Switzerland again calls on the Kingdom 
of Saudi Arabia to simplify 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 effecti ve implementation of the requirements. 
Switzerland looks forward to further cooperation on this topic and would appreciate if the Kingdom 
of Saudi Arabia could take these comments into account.  
2.452.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saleem programme works through the development of integrated systems of regulations 
and standards that conform to internationally recognized professional practices by developing a 
highly efficient system for measuring pro duct safety indicators in the market through mechanisms 
and procedures that comply with the technical regulations of each product. Saber is an electronic 
platform that helps the local supplier and the factory to register the required conformity certificate s 
electronically for consumer products, whether imported or locally manufactured, in order to enter 
the Saudi market. The platform also aims to increase the safety level of products in the Saudi market. 
Saber Platform was developed according to the highest  standards of efficiency in terms of 
registration speed, as well as in reducing the time spent for beneficiaries. The platform was created 
to ease export/import and traceability to ensure product compliance. Multiple organizations are 
involved in the proce ss and linked to the Saber platform to assure ease of communication and to 
improve the services provided to the consumer.  
2.453.   The validity of the certificate is one year for the certificate of conformity and three years for 
the Saudi quality mark. However, the  test report can be valid for three to five years if nothing has 
been changed in the production line or the composites of the product. It should be noted that Saudi 
Arabia has launched several initiatives to minimize the impacts of the COVID -19 pandemic, s uch as 
reducing the costs of the shipment conformity certificate by 30%, acceptance of commodities test G/TBT/M/82  
 
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  reports issued by accredited laboratories in the country of export for three previous years without 
the need for new tests, and postponing visits to pro duction lines for products subject to this condition 
before obtaining conformity certificates, and issuing conformity certificates without this condition as 
well as carrying out online auditing for products subject  to Quality Mark. Regarding the ceramic 
products, Saudi Arabia facilitates and expedites the procedures for granting SASO Quality Mark in 
European countries by authorizing several conformity assessment bodies (CABs) based in EU, to 
carry out SASO quality mark inspection procedures on behalf of SAS O, and serve ceramic 
manufacturers located in EU. 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. The GCTS validity harmonized with the validity for the certificate (five 
years); the economic operator (EO) has the right with a flexible mechanism to choose the activation 
for GCTS up to the EO choice. Following t he mandatory implementation of the new guidance since 
1 Octo ber 2020, we will work together to  observe the implementation for these procedures, the 
feedback important from all parties for SASO and GSO to ensure continuous improvement. We 
strongly advise all toy factories to contact the NBs according to the GSO Tech nical Regulation for 
Toys scheme (listed in Saber platform) for detailed explanations regarding the test report and GCTS 
requirements. In respect of the legal representative requirements for importing companies, it is 
mandatory to have Saudi commercial reg istration number (CR) in order to access to the Saudi Arabia 
market. Saudi Arabia is always willing to cooperate with EU and Switzerland, and we will take all the 
above remarks and comment under the highest consideration.  
2.1.3.48   India – Toys (Quality Control) Ord er, 2020 ( G/TBT/N/IN D/131 ); Amendment in 
Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(G/TBT/N/IND/143 ) (IMS ID 632101) 
2.454.   The representative of the European Union  provided the following statement. The European 
Union is strongly concerned 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 
WTO TBT Committ ee in February 2020 and submitted written comments on 30 and 31 March 2020. 
So far, the EU is not aware of any response of India to our concerns. In addition, the EU would like 
point out further concerns. The BIS has recently released its product manual an d the situation seems 
deteriorating due to the following elements: (i) the label needs to be printed on the primary 
packaging and cannot be applied with a sticker; (ii) the QCO requires factory audits, and BIS does 
not know how its officers will travel ove rseas with global travel restricted due to the pandemic; 
(iii) according to the available information, it seems that only three of the 15 accredited laboratories 
in India are running normally and will be responsible for testing all the SKUs for the entire industry. 
Moreover, despite the extension of the entry into force of the system until 1 January 2021, there is 
no clarity on the procedures and timeline, especially for foreign audits. Also, there is a lack of clarity 
in relation to if the products already  placed on the market before 1 January 2021 (existing stock) 
can continue to be sold. The EU would be grateful if India could respond directly to the concerns 
mentioned in the previous EU written comments, as well as to the new concerns.  
2.455.   The representative  of China  provided the following statement. The Toys (Quality Control) 
Order stipulated that toys for use in play by children under 14 years of age shall conform to the 
corresponding Indian standards and obtain compulsory certification. Manufactures export ing toy to 
India are faced with repeated testing , factory inspections, the payment of an additional USD 10,000  
deposit, application fee, annual licence fee, ISI logo fee. China kindly requests that India considers 
the burdens on enterprises, especially sma ll and medium enterprises, cancels the compulsory 
certification, or only selects high -risk toy categories for mandatory certification. The Toys Order 
requires that the goods or articles shall bear the Standard Mark under a licence from the Bureau as 
per Sc heme -I of Schedule -II of BIS (Conformity Assessment) Regulations, 2018, and the Bureau 
shall be the certifying and enforcement authority for the goods or articles. As of now , there are two 
to eight third -party laboratories certified by BIS for IS 9873 and IS 15644, which is not sufficient. 
As National Accreditation Board for Testing and Calibration Laboratories (NABL) is a member of ILAC, 
it is recommended that the definition of third -party labs includes both NABL -accredited laboratories 
and all ILAC -accred ited laboratories.  
2.456.   The Toys Order came into force on 1 September 2020. However, due to the impact of COVID -
19 epidemic, international travel restrictions still exist, and it is difficult in arranging factory 
 
101 For previous statements follow the thread under IMS ID  632 (unde r dates raised and references) . G/TBT/M/82  
 
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  inspections in time. The transition period curre ntly granted by the Order is not enough. According 
to Article 5.9 of the TBT Agreement, China requests that India grants a transition period of at least 
two years from the date of entry into force of the order. According to the new policy, sample should 
be randomly selected from each consignment and be sent to NABL -accredited laboratories for 
testing, while customs clearance could only be given against passing the sample testing. China is 
concerned about the potential delay to customs clearance and storage costs resulted from the 
random checks and testing. In addition to the certificate of NABL -accredited Labs, China requests 
that India recognizes the certificate issued by a laboratory accredited by ILAC. As NABL is a member 
of ILAC, it is recommended that I ndia accepts the results of foreign laboratories accredited by ILAC.  
2.457.   The representative of the United States  provided the following statement. The United States 
has repeatedly raised concerns with India's treatment of imported toys since 2017. With each ne w 
iteration of its QCO, India has made it more difficult for exporters to successfully bring safe toys to 
market. On 7 February 2020 India notified the QCO, which we understand to have entered into force 
on 1 September 2020. During the May 2020 TBT Committ ee meeting, India noted  that industry could 
request an additional transition period beyond 1 September. However, on 21 August, India denied 
industry's request for an extension of the final implementation date for an additional 9 -12 months. 
On 28 August, th e United States submitted a request for an extension of four to six months to India's 
Enquiry Point. India has not replied to the request. On 16 September, India published an Order in 
the Indian Gazette which postponed the implementation date of the QCO fr om 1 September to 
1 January 2021. Although we appreciate this additional time, it is not adequate. We request that 
India extend the implementation date by at least another four to six months.  
2.458.   US industry estimates that it will take at least another four to six months beyond 1 January 
2021, if not longer, to bring products into compliance with the QCO, given the unanticipated and 
unprecedented disruptions caused by the COVID -19 pandemic. The add itional time will also help 
avoid a major disruption to India's toy market. The QCO disproportionately impacts foreign 
manufacturers. The licensing process required to obtain a BIS mark is lengthy. Securing timely 
inspections of foreign manufacturing facil ities by BIS will likely not be possible in the near future due 
to the pandemic. US industry also anticipates delays in conducting testing and certification in 
laboratories accredited by India's National Accreditation Board for Testing and Calibration 
Laboratories (NABL). US industry reports that only three of the 15 NABL laboratories are operating 
at normal capacity due to the pandemic. Therefore , we reiterate our request that India extend the 
transition period an additional four to six months. We also req uest that India clarify how QCO is 
affecting products that are already in India's retail supply chains and outlets.  
2.459.   The representative of Canada  provided the following statement. Canada supports the 
concerns raised by other Members and wishes to reiterate its statement from the May 2020 
meeting.102 Canada kindly requests that India provide responses to Canada's concerns with regard 
to this measure.  
2.460.   In response, the representative of India provided the following statement. India would like 
to thank the EU, the US and China for their continued interest in the India Toy market. However, 
India would like to  state that there is no proposal to further extend the QCO on Toys beyond 1 
January 2021. A four -month extension beyond 1 September 2020 is provided to clear the inventories 
and get a BIS licence.  
2.1.3.49   Australia - Maturation requirements for imported alcohol (IMS ID 636103) 
2.461.   The representative of Brazil  provided the following statement. Brazil shares Australia's 
legitimate concerns with ensuring high -quality standards for the commercialization of alcoholic 
beverages in its domestic market. Notwithstanding , when applied to cachaça, Australian technical 
requirements for imported alcohol are more trade restrictive than necessary to protect such 
legitimate objecti ves. 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 sugarcane p roducts), under which cachaça is classified in Australia. 
 
102 G/TBT/M/81 , para. 1.84.  
103 For previous statements follow the thread under IMS ID  636 (under dates raised and references) . G/TBT/M/82  
 
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  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.  
2.462.   Following a public consultation in late 2019, the Australian Border Force (ABF) is now further 
exploring a potential avenue to amend the Customs Act 1901 (Customs Act) that would enabl e the 
legitimate importation of certain alcohol products into Australia whilst retaining the maturation 
requirements for brandy, whisky, and rum. According to a more recent public consultation, the 
Australian government is developing an approach that is lo oking to retain Australia's existing 
maturation requirement for imported brandy, whisky, and rum, but would establish a list of products 
exempt from this maturation requirement. The proposed list of exempt products would include 
cachaça and pisco and bourb on. Brazil acknowledges progress in the course of action proposed in 
its most recent public consultation. Our private sector will continue to provide inputs to this 
regulatory process. In light of the above -mentioned concerns, could Australia please confir m if this 
new regulation will also establish new labelling requirements for products other than rum, brandy 
and whisky? Could Australia provide timeframes for the publication of the final text? We look forward 
to continuing our bilateral engagements with A ustralia on this matter. Brazil will continue to raise 
this STC until current maturation requirements for imported alcohol no longer apply to cachaça.  
2.463.   In response, the representative of Australia  provided the following statement. We thank 
Brazil for its in terest in Australia's review of maturation requirements for imported alcohol and we 
would be happy to further discuss Brazil's concerns regarding this matter. Australia's review of its 
legislative framework for the importation of unmatured alcohol products  under section 105A of the 
Customs Act is on -going. Australia 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. The  review process is considering potential pathways to enter 
unmatured spirits without undermining Australia's consistent approach to maturation requirements. 
Australia acknowledges Brazil's engagement with the review of Australia's maturation requirements 
for alcohol. Representatives from the Brazilian Embassy participated in the 2019 consultation 
sessions on the review process led by the ABF. The issues raised in those consultation sessions, as 
well as written submissions, will be taken into consideration. The Australian Government has recently 
commenced a further stakeholder consultation, through the release of a consultation paper, to seek 
views on a refined proposed approach to amend s105A of the Customs Act. The consultation paper 
was sent directly to th e participants of the 2019 consultation sessions, including the Brazilian 
Embassy in Canberra. It is also available on the Department of Home Affairs website.104 Written 
submissions are due to the ABF by 11:59 pm AEDT 18 November 2020. The Government will c onsider 
any potential legislative changes following the outcome of this consultation.  
2.1.3.50   European Union - EU Commission Regulation (EU) 2019/2013 for Energy 
Labelling of Electronic Displays, G/TBT/N/EU/610  (IMS ID 634105) 
2.464.   The representative of the Republic of Korea  provided the following  statement. Korea would 
like to make some comments regarding this regulation as follows. According  to your reply on 12 
August 2020, the EU told that the amendments of test methods would be published in early 
September. However, they have not been published  yet, so the Korean companies have faced 
difficulties in compliance with EU regulations. Korea would like to ask the EU to give a transition 
period for compliance with regulations at least six months after the final announcement of the official 
test method s or suspend the implementation of labelling regulation until 1 March 2021.  
2.465.   In response, the representative of the European Union  provided the following statement. 
The draft amending acts clarifying a range of aspects including some relating to the test me thods 
have in the meantime been published and are available online for public feedback until 3 
November.106, 107 In this context, we would like to stress that the clarifications relating to the test 
methods referred to in Annex IV to the Regulation are the s ame as those mentioned in, and attached 
 
104 www.homeaffairs.gov.au/reports -and-publications/submissions -and-discussion -papers  
105 For previous statements follow the thread under IMS ID  634 (under dates raised and references) . 
106 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/12471 -Energy -efficiency -
updated -EU-rules-on-ecodesign -and-energy -labelling   
107 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/12499 -Energy -efficiency -
updated -EU-rules-on-energy -labelling   G/TBT/M/82  
 
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  to, the Commission's response  from 12 August108, and which have been available publicly online 
since early July. In terms of timing, we can only reiterate that there are currently no plans to delay 
the date of applica tion of the concerned regulations, which therefore remains 1 March 2021. 
However, as regards compliance with the 1  November 2020 deadline for certain obligations relating 
to labelling and product registration, the Commission has already called upon nationa l market 
surveillance authorities to show flexibility taking into account the particular situation.109 We remain 
confident that this approach will be sufficient to provide the flexibility needed by manufacturers. 
Finally, let me once again express our appre ciation for your efforts to ensure timely compliance and 
our desire to assist, to the extent possible, should new difficulties arise.  
2.1.3.51   India – FSSAI's Food Safety and Standards (Food Products Standards and Food 
Additives) Regulations, 2011 and the new imple menting veterinary certificate for dairy 
products, G/SPS/N/IND/236  (IMS ID 633110) 
2.466.   The representative of the European Union  provided the 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 Regulatio n defines cheese 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 t o 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. Similar difficulties arise for cheese by -products, 
such as whey and lactose. While the EU fully supports the importance of labelling the presence of 
animal rennet, the EU considers th at this new certificate is not proportionate and not in line with the 
TBT Agreement. Veterinary certificates are to address sanitary (human or animal) health issues. 
There is no scientific evidence that cheese produced with animal rennet is harmful to heal th, 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 and its by -products, as it was previously the case. This label would allow 
consumers to make an informed choice.  
2.467.   The representative of the United States  provided the following statement. The United States 
appreciates the discussion related to India's market access requ irements for dairy imports, and 
shares concerns that India's requirements may be more trade restrictive than necessary to fulfil its 
legitimate objective. The United States is concerned that the India Certificate for Import of Milk and 
Milk Products into I ndia contains the statement "The source animals have never been fed with feeds 
produced from internal organs, blood meal and tissues of ruminant origin ". While we recognize 
India's domestic cultural and religious sensitivities, India has acknowledged that there is no scientific 
evidence that dairy products produced from source animals fed with feeds that include products of 
ruminant origin present a sanitary or health risk. Therefore, this language is inappropriate for 
inclusion in an import certificate. Th e United States also shares concerns with the European Union 
that the new veterinary import certificate for milk and milk products based on Food Safety and 
Standards Regulation 2011 does not allow cheese containing animal rennet to be exported to India. 
The United States requests that India allow the entry of these dairy products as long as they are 
clearly labelled.  
2.468.   In response, the representative of India provided the following statement. EU had raised this 
STC in the last meeting, and India gave its repl y. Since the statement presented by the EU is not 
materially different than it did in the May meeting, India believes there is no more additional 
information to be provided.  
 
108 Commission reference Ares(2020)42257 02 
109 https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.C_.2020.182.01.0002.01.ENG&toc=OJ:C:2020:182:TOC   
110 For previous st atements follow the thread under IMS ID  633 (under dates raised and references) . G/TBT/M/82  
 
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  2.1.3.52   Myanmar - Regulation on importation of alcoholic beverages (IMS ID 640111) 
2.469.   The repr esentative 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 a communication on 20  September  2019 (523/01/058/20.IX.2019) containing its 
concerns regarding this measure and has not received a reply.  The delegation of Mexico reiterates 
its concern regarding the 12 -year ageing requiremen t contained in the draft procedures. This 
requirement would imply that the importation into Myanmar of such products aged less than 
12 years will not be permitted. In Mexico's case, the ageing requirement would prevent tequila 
imports into this market, as none of the types of tequila produced under the corresponding technical 
regulation (Official Mexican 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 products, 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.  
2.470.   The representative  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 draf t procedures on the importation of 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 above Agreement.  In light 
of the abo ve, the delegation of Mexico kindly reiterates the following requests to the delegation of 
Myanmar:  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 comm unication.  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.  It requests that the Members 
of the WTO's TBT Commit tee 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 implementation.  The 
delegation of Mexico thanks the delegation of Myanmar for considering this stateme nt and the 
requests made therein.  
2.471.   The representative  of Myanmar  did not provide a response to the concerns raised. These 
concerns were subsequently transmitted  to the relevant authorities.  
2.1.3.53   European Union - Regulation (EU) 2018/848 of the European Parliament and of 
the Council of 30 May 2018 on organic production and labelling of organic products, 
G/TBT/N/EU/211/Add.1 , G/TBT/N/EU/713 , G/TBT/N/EU/748  (IMS ID 614112) 
2.472.   The represen tative of Mexico  provided the following statement. The delegation of Mexico 
refers to Regulation (EU)  2018/848 of the European Parliament and of the Council on organic 
production and labelling of organic products, which was notified to WTO  TBT Committee Me mbers 
as document G/TBT/N/EU/211/Add.1  on 18  February  2019, and to Draft Commission Delegated 
Regulation amending Part  I of Annex  II to Regulation (EU)  2018/848 as regards the use of 
in-conversion and non -organic plant reproductive material, notified on 22  April 2020 in d ocument 
G/TBT/N/EU/713 . The Government of Mexico sent a communication on 31  August  2020 to the 
Directorate -General for International Cooperation and Development in the European Commission, in 
which concerns were raised regarding:  Restricting participation to producers with less than five 
hectares of farmed land;  Limiting the maximum number of members per organization to 1,000 
producers;  The imprecise frequency of internal monitoring of certifications;  Defining the 
geographical proximity of group members; and  Limiting the income of sma ll farmers.  While the 
Government of Mexico appreciates that the European Union has shown a bilateral openness to 
discussing this topic, it reiterates its concerns over the proportionality of the measure in relation to 
the objective pursued, and its potenti al implications for international trade in organic products, with 
a focus on small producers.  Furthermore, we consider it vital to reiterate the importance of meeting 
international commitments, particularly on conformity with international standards and de veloping 
measures on a technical and scientific basis.  In light of the above, the delegation of Mexico requests 
that the delegation of the European Union give due consideration to the comments submitted 
 
111 For previous statements follow the thread under IMS ID  640 (under dates raised and references) . 
112 For previous statements follow the thread under IMS ID  614 (under dates raised and references) . G/TBT/M/82  
 
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  concerning this regulation . The delegation of Mexico thanks the delegation of Myanmar for 
considering this statement and the requests made therein . 
2.473.   The representative  of the Dominican Republic  provided the following statement. The 
European Union will implement secondary legislation under Organic Regulation (EU) 2018/848, 
which includes fundamental changes to the group certification system in third countries . 
These  measures presented by the European  Commission would undoubtedly have a severe, 
negat ive and immediate impact on organic exports from the Dominican Republic to countries  in the 
European Union . The Dominican Republic is one of the world's leading producers of organic bananas 
and coco a. These sectors constitute the two main exports to the E uropean market, representing 
approximately 33% of the value of total exports, and creating 350,000 direct and indirect jobs.  
Within the Organisation of African, Caribbean and Pacific States (OACP S), our country is the largest 
exporter of organic products t o the E uropean Union, accounting for 62% of total imports . Globally, 
it is only surpassed by  China and Ukraine . European consumers have favoured Dominican organic 
products because they come from sustainable programmes that comply with both international 
certification and Fairtrade standards . There can be no doubt that the Dominican Republic's success 
is closely linked to the way in which the country's small -scale farmers have been able to group 
together in cooperatives or associations. The changes proposed in the European Union's draft 
secondary legislation pose a serious challenge to our farmers' living standards, their families, their 
business models, rural communities and their participation in global value chains . 
2.474.   The Dominican Government is deeply conce rned by the nature of the implementing  and 
delegated  acts of Regulation 2018/848, which contains proposals that would undermine efforts made 
over many years by these cooperatives to develop environmentally sustainable agriculture and 
communities that are s ocial and economically viable . A further cause of particular concern is the 
administrative and financial implications for groups of producers that are currently certified as 
"processor/exporter managed groups", since they would either have to form separate  legal entities 
or rely on third parties to carry out the processing and exportation of their products . Not only does 
this significantly raise transaction costs and affect the management of the production process, but 
it also has a negative impact on trace ability and the bargaining power of farmers, resulting in 
decreased revenue and increased costs, and thereby threatening the sustainability of their 
businesses . Moreover, the establishment of a maximum limit of five hectares for each member of 
the group wo uld affect the viability of many producer associations, because it would exclude those 
farmers who grow organic products on larger areas of land, for whom obtaining individual 
certification is not economically feasible . In some cases, the cost of certifica tion could represent 60% 
of their net revenue, which would prevent them de facto  from exporting to the European Union.  
Consequently, we suggest that the maximum limit of hectares be increased, or that the requirement 
be removed for associations of small -scale producers . 
2.475.   These proposed changes to group certification standards create an unnecessary 
administrative and financial burden for organic producers in developing countries, and especially 
small -scale farmers . Moreover, they are not conducive to achievin g the objective set out in the  
secondary legislation of Regulation 848/2018. The Dominican Republic questions whether these 
requirements are necessary for achieving the relevant objective . The implementing  and delegated 
legislation of Regulation (EU) 848/2 018 on organic production and the labelling of organic products 
would have a severe impact on the banana and cocoa sector in the Dominican Republic. It would 
result in a loss of competitiveness in relation to other countries producing the same goods . Some 
members of associations or cooperatives would be under a group certification scheme and a 
collective internal control system (ICS), while other members would hold independent certification. 
The association or cooperative would have less control over a nd a reduced ability to monitor the 
latter in areas such as farm management, completing registers and product sales . Producers with 
independent certification may sell their fruit to others, w hich would have negative implications for 
the collective commitme nt to the organization's clients. This change undermines the strong  trade 
ties that have been  established over many years, through  which associations and cooperatives 
guarantee the sale and supply of products, as well as compliance with various types of st andards 
and certification schemes .  
2.476.   The legislation would also have a negative impact on the management of other types of 
certification that, until now, have been managed by a single internal control system (such as global  
GAP, Rainforest or biodynamic cer tification ). Cooperatives and associations would have different lists 
of members and registers for the various certification schemes, which very often are audited by the 
same monitoring body. This would have negative consequences  for inspection, increasing  its G/TBT/M/82  
 
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  complexity, and for the unified management of registers and data. Moreover, 44% of producers run 
the risk of being excluded from banana production because they lack the economic and 
administrative capacity required for individual certification .  The livelihoods of over 15,000 families, 
particularly those in the country's banana -producing border areas, could be adversely affected. As 
a result, there would be a fall in remittances sent by migrant workers to the Republic of Haiti, thereby 
increasing pover ty in the Dominican Republic's most marginalized provinces and causing a decline 
in foreign exchange by over 110 mill ion dollars annually . Lastly, the measures that the European 
Union is seeking to adopt constitute provisions subject to the TBT Agreement. They would thus run 
counter to Article 5.1.2 of this Agreement, which prohibits WTO Members from adopting conformity 
assessment procedures " with a view to or with the effect of creating unnecessary obstacles to 
international trade ". These measures also app ear to be incompatible with Articles 2.1 and 2.2 of the 
Agreement.  
2.477.   The representative of Paraguay  provided the following statement. My delegation wishes to 
thank the delegation of Mexico for including this item on the agenda and to register our interest in  
it. We will be following this matter closely, as the regulation is still being analysed in our capital to 
determine how both the five -year maximum limit and the limits established for producer group 
certification would affect trade. The considerable incre ase in the costs of certification would make 
this economically unviable for our producers . 
2.478.   The representative of Jamaica  provided the following statement. I make this statement on 
behalf of the African, Caribbean and Pacific (ACP) Group. We take note of th e EU's notification under 
G/TBT/N/EU/748  of 18 September 2020 providing information on rules for the implementation of 
Regulation (EU) 2018/848 regarding controls and other measures in respect of traceability and 
compliance in organic production and the labelling of organic products.  The organic sector in our 
countries is an important driver of sustainable production and trade and plays a leading role in our 
national strategy towards sustainable food systems. In respect of the proposed regulation, two of 
our main concerns are: Article  4 (Composition and maximum size of a group of operators) which 
requires a member of a group of operators to register to only one group of operators for the same 
activity for a given product, as well as requiring the maximum size of a group of operators to  be 
2,000 members. Article 7 (minimum percentages of controls and sampling) which requires a 
minimum of 5% of operators that are members of a group of operators, and requiring that not less 
than 10 members shall be controlled in connection with the verific ation of compliance referred to in 
paragraph 3 of Article 38 every year. We understand that where the group has 10 or less than 10 
members, all members shall be controlled in connection with the verification of compliance referred 
to in paragraph 3 of Arti cle 38.  
2.479.   The provisions for group certification under the current EU organic rules have enabled many 
small -scale farmers and MSMEs in developing countries to become  organic certified and to access 
the EU market. These players risk being disproportionally af fected by the new rules under Regulation 
(EU) 2018/848. While we accept that improvements are needed in the management of group 
certification, these proposed changes risk creating unnecessary barriers, and disproportionately 
increases certification costs f or the many small -scale farmers that make up our exports, and who 
operate primarily through organized groups or cooperatives. It is not at all clear to those who have 
experience on the ground how these proposed changes will address the main concerns expres sed 
by the European Commission about the quality of group certification, or why they cannot be resolved 
through other means that are more sensitive to the context in which many of the smallest and most 
vulnerable organic players operate. We feel that these  proposed changes will exacerbate the 
negative impact of changes already made to the rules, which means that cooperatives, federations 
of cooperatives, and processors/exporters with affiliated farms are no longer recognized as certifiable 
legal group entit ies. Such arrangements are very common in developing countries, and the norm in 
sectors such as fruit and vegetable. They are crucial in linking groups to marketing and advisory 
services, and there is no evidence that control systems in such groups are wea ker. 
2.480.   With this said, we believe that there should be no maximum group size. One of the possible  
less-restrictive alternatives could be a situation where large groups have clustered structures that 
ensure appropriate management. We reiterate the importance of continuing to recognize 
cooperatives, federations of cooperatives, and processors/exporters with affiliated farms as 
certifiable legal group entities. The new rules should not be more trade restrictive for groups of over 
400 members. In light of the fac t that these issues would negatively affect the participation of 
developing countries and least developed countries (LDCs) in organic trade, we are calling on the 
EU to make the appropriate revision to the draft regulation in order to synchronise it with t he G/TBT/M/82  
 
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  principles governing the multilateral trading system, especially in the context of facilitating the 
successful integration of our members in global trade.  
2.481.   The representative of Colombia  provided the following statement. The delegation of 
Colombia would like to express its interest in this trade concern . In particular, we are raising 
concerns about how the criteria for obtaining certifications for small producers and associated costs 
would be defined.  We will be follow ing up on the EU's re plies and any developments concerning  this 
matter.  
2.482.   The representative of Ecuador  provided the following statement. As the European market is 
very important for Ecuadorian organic products, we have been ac tive in Brussels, sending 
observations and comments during the consultations with parties concerned by this draft Regulation. 
I wish to highlight that my country will be following developments  on this matter.  
2.483.   In response, the representative of the European  Union  provided the following statement . As 
explained in the TBT Committee meeting last February, under the current EU organic regulation, 
group certification is not currently possible for operators in the EU. They must be certified 
individually, regardles s of their activity and size. However, group certification has been made 
possible in third countries. The Commission published guidelines in 2008 providing for specific 
requirements. The new organic Regulation (EU) 2018/848 establishes a system of group ce rtification 
in the EU, aiming at reducing the inspection and certification costs for small farmers and operators. 
This possibility has been accompanied by conditions for the system to offer guarantees in terms of 
control efficiency that are comparable to i ndividual certification and to limit the group certification 
only to small producers. We referred in detail to those conditions at the TBT Committee meeting last 
February. The Commission is empowered to adopt secondary legislation concerning, in particular , 
the set -up, composition and functioning of the internal control system and to lay down specific rules 
regarding the dimension of a group of operators. The aim is to conclude the on -going technical 
discussions with EU member States and to adopt the releva nt legislative acts at the end of March 
2021. Third countries are free to set up their own standards for organic farming. Organic is a 
voluntary scheme.  However, when an organic product originating in a third country is exported to 
the EU by means of contr ol bodies certified by the Commission, this product must comply with EU 
organic production rules, including provisions on group certification.  
2.484.   The Commission is considering concerns expressed by WTO Members very carefully  and 
takes them into account in the  preparatory work and discussions with EU member States. The 
objective is to achieve the best possible compromise between the need for group certification that 
provides with the same level of assurance as individual certification, while facilitating access  to 
organic production by small producers, including in third countries. The European Union would like 
to clarify that to import organic products from third countries, the Certificate of Inspection (COI) 
shall be issued before the consignment leaves the th ird countries. This requirement has always been 
enshrined in Commission Implementing Regulation 1235/2008 to ensure traceability. Commission 
Implementing Regulation (EU) 25/2020 has not added any new requirement, but only a legal 
clarification to avoid mis interpretations. As to the potential delay of the issuance of the COI, the 
Commission has already included a provision allowing to notify the transport information within 10 
days from issuance of the COI and, in any case, before MS authorities endorse it. Meanwhile, the 
Commission has communicated to the Control Bodies how to proceed from a technical point of view.  
2.1.4   Report on eAgenda  
2.485.   The Secretariat provided an update regarding enhancements to the eAgenda platform. There 
was strong engagement and use of eAge nda by Members. He reported that 97%  of STC statements 
were uploaded  by Members to eAgenda, and there were 178 eAgenda users from 69 Members.  In 
light of the feedback provided by Members at the  June 2020 informal meeting  (JOB/TBT/367 ), the 
Secretariat  implemented some enhancements to eAgen da, outlined in document JOB/TBT/368 . 
2.2  Exchange  of Experiences  
2.2.1   Technical assistance  
2.486.   The Chair provided the moderator 's report on technical assistance. The full report is 
contained in G/TBT/GEN/306 . G/TBT/M/82  
 
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  2.2.2   Technical Regulations  
2.487.   The Committee heard the moderator 's report on technical regulations. The full report is 
contained in G/TBT/GEN/307 . 
2.2.3   Conformity assessment procedures  
2.488.   The Chair  recalled previous submissions made by Members for the develop ment of guidelines 
on conformity assessment ( European Union in JOB/TBT/322 , the United States in JOB/TBT/326 , 
Australia in JOB/TBT/347 , Japan in JOB/TBT/349  and Canada in JOB/TBT/358) . He noted, too, that 
there was a submission pending from China. In addition, the Secretariat had presented, at the 
Committee 's informal meeting of 24 September, its background note  providing an overview of the 
TBT's Committee 's work on conformity assessment  procedures ( JOB/TBT/224/Rev.1 ). He reaffi rmed 
his intention, as Chair, to work closely with Members to bring this work to fruition; he said that the 
conclusion of the Ninth Triennial Review next year could provide a natural target for completing this 
work.  
2.489.   The representative  of the Chile thanked  delegations for their proposals . He said that Chile 
was currently reviewing these proposals and look ed forward to submitting its own proposal  in due 
course . 
2.490.   The representative  of the United States  stressed the importance of the submission of papers 
before  making a determination of how the Committee would move forward. There were still many 
Members that had not offered any views, including on National Quality Infrastructure (NQI); it was 
important, she said, to hear about national practices and the experien ces of Members. She also 
noted that the Committee was likely to spend more time in upcoming meetings on the 9th Triennial 
Review. And, in addition, there had been 80 specific trade concerns at the current meeting – and 
that number continued to grow. There was a question of how much time would be available for the 
negotiations. She wondered if the Committee could suspend work on the guidelines while work on 
the 9th Triennial Review was ongoing.  
2.491.   The representative  of Colombia  acknowledged the importance and the utility of the 
Committee 's work on the guidelines. She welcomed all national experiences and information that 
could be shared from other Members. Colombia, she said, was currently reviewing the proposals on 
the table. In her delegation 's view, the guidelines would need to be non -binding and not favour a 
particular focus (for the elaboration of conformity assessment procedures). They would, at the very 
least, need to take into account best practices and successful experiences, both regional and 
national. It would also be important for the guidelines to go into depth on risk -based conformity 
assessment procedures, in other words, they would need to take into account the cost and risks of 
non-conformity, as well as incentives to adopt conformity mechani sms. In this regard, Colombia was 
of the view that it would be timely to go into detail an d consider impacts also on human, animal and 
plant health – as well as environmental considerations. Colombia was also of the view that it would 
be important to deepe n discussions on mutual recognition agreements and arrangements.  
2.492.   On terminology, Colombia stressed the importance that the guidelines be developed – and 
structured – with simple terminology. This could include checklists, graphical or other visual 
element s. A simple approach would ensure better understanding of these topics, not only by 
regulators, but also by SMEs which, for Colombia, were at the heart of the economy. These 
enterprises often saw regulations and standards as barriers to trade.  
2.493.   The represe ntative of the European Union  recalled their written submission and said that her 
delegation was keen to see submissions from other Members. While she acknowledged the burden 
of the Committee 's work, she stressed the importance of this work continuing alon g with the triennial 
review.  
2.494.   The representative  of Paraguay  stressed that the guidelines needed to take into account the 
needs and specific regulations in different Members; it needed to be considered that Members had 
different types of economies, differe nt industrial bases, different regulatory frameworks – as well 
and varying capacity. There should not be, she said, any "one-size-fits" all approach – and it was 
important to allow all Members the opportunity to contribute to the process.  G/TBT/M/82  
 
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  2.495.   The representati ve of the United States  stressed that her delegation was not in a position to 
agree on a target date for completing the work on the guidelines by the 9th Triennial Review. She 
reiterated her earlier comment on the overall work burden before the Committee – and said that 
despite the virtual meetings working well, this was not a substitute for in -person meetings.  
2.496.   The representative  of Ecuador  stressed the importance of maintaining an active debate on 
conformity assessment so as to move forward with the work o n the practical guidelines; Canada 's 
proposal, in particular, was very constructive. For Ecuador, policy flexibility was very important – 
the guidelines would need to support various policy objectives.  
2.497.   The Chair  requested  the Secretariat, in response to t he various comments from Members 
about the need for more time, to extend the Committee 's meetings in 2021 by half a day . He said, 
too, that the Committee could work on both the guidelines and the triennial review in parallel; and 
informal meetings, such as  the one on 8  December, could provide further opportunities for advancing 
work.   
2.498.   Regarding  the upcoming 8 December informal, the Chair recalled that at the informal 
meeting on 24 September, it had been suggested that delegations in the TBT Committee be gi ven 
an opportunity  (similar to what had been done in other Committees)  to share experiences on 
measures that had been adopted in response to COVID -19. The idea was to take some time to reflect 
on actions taken to facilitate trade , for instance in the trade of essential medical goods , in the context 
of the continuing pandemic. He recalled that the Secretariat had put together a factual information 
note on TBT notifications related to COVID -19 which had been  introduced to the Committee at the 
24 Septembe r informal meeting. This information  note (Standards, Regulations and Covid -19 – What 
Actions Taken by WTO Members ) was available on the WTO webpage.113  
2.2.4   Transparency  
2.499.   Regarding statements  from Members under Article 15.2 of the TBT Agreement, the Chair 
recalled that the Annual Review , circulated on 19 February 2020 (G/TBT/44 ), contained,  amongst 
other information, details on Members' statements of implementation. Since the TBT Committee 's 
meeting in February 2020, Burkina Faso ha d submitted its statement , contained in 
G/TBT/2/Add.130 . In addition, the interventions from the  United Kingdom  and Cote d 'Ivoire ha d 
been circulated as supplements  (G/TBT/2/Add. 128/Suppl.1  and G/TBT/2/Add.127/Suppl.1 , 
respectively . 
2.500.   With respect  to follow -up on some  of the transparency -related recommendations, which this 
Committee had adopted in 2018 in the context of the Eighth Triennial Review , the Chair recalled 
that S ection 3 of the Aid e-Memoire (JOB/TBT/273 /Rev.6 ) provide d a record of the Committee 's work 
on transparency.  One of the recommendations had been for the Committee to adopt a revised 
addendum template . In line with this, a t its November 2019 meeting, the Committee had adopted 
a new format for this purpose, which can be found in document G/TBT/35/Rev.1 .  This had enabled  
Members to indicate more clearly when a notified measure entered into force and where it could be 
obtained, amongst other changes.   
2.501.   The Secretariat  confirmed  that the revised Addendum format  (G/TBT/35/Rev.1 ) had become 
operational on 16 July following the completion of adjustments to various online systems. The main 
difference with the earlier version of the format was that when providing updates on notified 
measures, Members could  now indicate the reason for the Addend um by selecting from among a 
series of tick -box options and complement with any relevant dates and links – making it easier to 
track the evolution of notified measures. The new format had required notifying authorities to adjust 
their practices  somewhat . A total of 318 notifications had been circulated with the new format ; about 
half had  specifically referred to the entry into of force of previously notified measures and included  
final texts. The remaining  had indicated updates such as on change of comment period, change of 
scope or withdrawal of a measure. Further details on the use of the new Addendum format would  
be provided in the Annual Review report to be issued early 2021.  
2.502.   The Secretariat  went on to note that the online Notification Submission System,  through 
which 88 % of TBT notifications had been submitted in the previous year , had also undergone a 
 
113 https://www.wto.org/english/tratop_e/covid19_e/standards_report_e.pdf   G/TBT/M/82  
 
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  series of enhancements. One of the most significant changes relate d to the incorporation of more 
recent versions of HS Codes into the system, making it ea sier for Members to find the specific codes 
for products they intend to regulate. This was relate d to another Triennial Review recommendation 
of the Committee, on improving product information provided in notifications .  
2.503.   The Chair encouraged  Members to make use of the new addendum format  and to provide 
feed-back to the Secretariat. He recalled that another triennial review  recommendation had been for 
Members to discuss the dissemination of comments on notified measures and replies thereto on a 
voluntary bas is, possibly via ePing. It was suggested that increased transparency on exchange of 
comments and replies could allow for more efficient discussion and resolution of specific trade 
concerns. This could enhance coordination between Members, helping to avoid unnecessary barriers 
to trade. It could also help Members observe and learn from the process. He noted that also here 
the Secretariat ha d introduced some enhancements to ePing to facilitate the process.  
2.504.   The representative  of Switzerland  referred to the vi deo prepared by the Secretariat to 
demonstrate the sharing of comments feature of ePing.114 His delegation encouraged Members to 
use ePing to publish their comments on notifications and replies on such comments . Members could 
decide to  publish the entire comments or repl ies, or only parts of these – or they could simply 
indicate that they had provided comments (or replies ). He stressed that there was added value to 
an increased transparency of handling of comments  because this allowed f or more efficient 
discussions, better coordination between interested Members and thus help ed to avoid unnecessary 
obstacles to trade.  The Swiss delegation proposed that the Secretariat prepare a draft document 
further clarifying the purpose and the practi cal steps for sharing comments and replies via ePing, 
underlining its voluntary nature as well as benefits. Such a document could be helpful for Members 
who intend to implement this recommendation.  
2.505.   The representative  of the European Union  thanked the S ecretariat for the new video and for 
the work they were carrying out to extend the functionalities of ePing. The EU was of the view that 
ePing should provide a comprehensive support to all TBT notifications, throughout their life -cycle 
and allow for the comple te treatment of and follow -up to TBT notifications. The EU  encourage d the 
Secretariat to pursue these efforts  and remained available for support that could be needed in the 
development and testing phases of an ePing updated tool.  
2.506.   The United States  said that her delegation had held a session with the WTO Secretariat on 
the use of ePing and posting comments to the system. The US was very encouraged by the function. 
One outstanding issue, however, was how comments would be treated and privacy of those 
comments . This was something the Committee needed to further discuss before the United State s 
would be comfortable with posting its comments on ePing. This was different than, for example, 
eAgenda which was an exclusive WTO tool.  
2.507.   The representative  of Canada  appre ciated Switzerland's pro posal and fully supported the 
facilitation of Members ' ability to comment – this was an important part of the implementation of 
the transparency procedures under the TBT Agreement, and it did contribute to avoiding 
unnecessary obsta cles to trade. Existing tools such as ePing already provided Members the 
opportunity to publish comments – if they wished – in line with their own domestic procedures. 
Nevertheless, as the US had pointed out, there were still some outstanding issues that m ight need 
to be discussed, such as privacy issues, so some time allocated to this for discussion would be good.  
2.508.   The Chair thanked  delegations for their input. He noted the suggestion, from Switzerland, 
for the Secretariat to produce a practical document o n how to provide comments using ePing. As 
this could be helpful to delegations, he asked the Secretariat to produce such a draft as a basis for 
further discussions.  
2.509.   Regarding next steps on transparency, the Chair recalled that the Committee was scheduled 
to hold a thematic session on 4 February 2021. The last thematic session the Committee had taken 
place in June 2019 ; that session had addressed a number of recommendations from the Triennial 
Review  (the moderator 's report is contained in G/TBT/GEN/265) .  He asked Members to come 
forward with any ideas or suggestions for specific areas that they would like the Committee to focus 
on in February. For example, in looking at the range of recommendations from the Triennial Review, 
and in particular  those that the Committee ha d not yet addressed in detail, he suggested that the 
 
114 https://www.youtube .com/watch?v=it5PN -vazuA&feature=youtu.be  G/TBT/M/82  
 
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  thematic session could consider the  question of how to improve product coverage information 
contained in notifications ( G/TBT/41 , 6.19.d.ii). Another recommendation, which was under the 
section on Technical Assistan ce (see G/TBT/41 , 7.12.c), was to develo p a good practice guide on 
how to prepare a comment on a notified measure.  
2.3  Other  Matters  
2.510.   The representative  of Chile suggested that the Committee revert to its earlier work on Good 
Regulatory Practices during 2021.  
3  NINTH TRIENNIAL REVIEW  
3.1.  The Committee adopted  the timeline  for the 9th Triennial Review as contained in document 
G/TBT/W/ 735.  
3.2.  The representative of the European Union  emphasized the role of the Review exercise in 
reinvigorating the regular work of the TBT Committee, as well as in reinforcing its deliberative 
function – the consolidated achievements so far had been substantive. She noted, in particular, the 
Committee 's work on the Guidelines for conformity assessment as important.  
4  TECHNICAL COOPERATION ACTIVITIES  
4.1.  The Secretariat  provided  an update on technical assistance. The full statement is contained in 
document G/TBT/GEN/305 .  
5  UPDATING BY OBSERVERS  
5.1.  The Committee  heard updates from BIPM, IEC, CODEX ( RD/TBT/328 ) CROSQ  (RD/TBT/331 ) 
and UNIDO ( RD/TBT/332 ).  
5.2.  Regarding pending requests ( G/TBT/GEN/2/Rev.14  and RD/TBT/1/Rev.6 ), the representativ e 
of Turkey  reiterated her delegation 's support, as stated in previous meetings, for the request for 
observer status from the Standards and Metrology Institute for Islamic Countries (SMIIC). The 
United States  noted that her delegation was not currently in a position to accept this request. The 
Chair  urged Members to consult with each other so that the Committee would be able to more 
constructively engage on this matter; he remained available to facilitate any such discussions.  
6  ANNUAL REPORT (2020) OF THE CO MMITTEE TO THE COUNCIL FOR TRADE IN GOODS  
6.1.  The Chair  drew the Committee 's attention to a draft of the Committee 's 2020 report , circulated 
on 6 October  and contained in document JOB/TBT/376 . It was proposed that th e draft be adopted 
on an ad referendum  basis. This mean t, the Chair explained, that  unless any delegation object ed, in 
writing , to the Secretariat before 20 November 2020, it would be considered adopted as contained 
in the draft. The report was so adopted  and circulated on 23  November  2020 in G/L/1379 .  
7  DATE OF NEXT MEETING  
7.1.  The next regular  meeting of the Committee will take place on 2 4-26 February 2021 . It will be 
preceded by a t hematic session on Transparency  on 4 February 2021  and an informal meeting on 
23 February . All scheduled dates of meet ings in 2021 are listed in JOB/TBT/364/Rev.2 .  
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