RESTRICTED  
  
G/TBT/M/83  
 
 
21 April  2021 
(21-3411) Page: 1/125 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 24-26 FEBRUARY 2021 
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  ................................ ................................ ...........................  122 
2.3   Report on Informal Meeting of 8 December  on Conformity Assessment Procedures, COVID -19 
Information Sharing and Workshop on the Role of Gender in the Development O f Standards  ..... 124 
3   NINTH TRIENNIAL REVIEW  ................................ ................................ .....................  124  
4   TWENTY -SIXTH ANNUAL REVIEW  ................................ ................................ ...........  124  
5   TECHNICAL COOPERATION ACTIVITIES  ................................ ................................ .. 124  
6   OBSERVERS  ................................ ................................ ................................ .............  124  
6.1   Updates  ................................ ................................ ................................ ..................  124 
6.2   Pending Requests  ................................ ................................ ................................ ..... 124 
7   ELECTION OF CHAIRPERSON  ................................ ................................ ...................  125  
8   DATE OF NEXT MEETING ................................ ................................ ..........................  125  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 19. 
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2.1.1   Withdrawn concerns  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  The Chair  reported that the following STCs had been withdrawn from the agenda at the request 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 Member:  
• Colombia - Good Manufacturing Practices of overseas production establishments - 
Draft Decree of the Ministry of Health and Social Welfare partially  amending Decree 
No. 1686 of 2012  
 
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/83  
 
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  • United States - Energy Conservation Program for Appliance Standards: Energy 
conservation standards for residential furnaces and commercial water heaters  
• Israel - Particular requirements for dishwashers of SI 900  
• Israel - General requirements for boxes and enclosures for electrical accessories for 
household and similar fixed electrical installations of SI 60670  
2.1.2   New Specific Trade Concerns  
2.1.2.1   China - CSAR - Draft Specifications for Cosmetic Registration and Filings; Draft 
Specif ications for Registration and Filing of New Cosmetics Ingredients; Draft 
Specifications for Cosmetic Efficacy Claim Evaluation, Provisions for the Supervision and 
Administration of Toothpaste, G/TBT/N/CHN/1454 , G/TBT/N/CHN/1524 , 
G/TBT/N/CHN/1525 , G/TBT/N/CHN/1526 , G/TBT/N/CHN/1527  (ID 6652) 
2.2.  The representative of the United States  provided the following statement. The United States 
appreciates China's notification of these four CSAR regulations, which contain requirements for 
companies placing general and special use cosmetic products and ingredients, including too thpaste, 
on the Chinese market. We understand that the measures notified to the WTO as 
G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525  and G/TBT/N/CHN/1526  are implementing measures for 
the Administrative Measures on Cosmetics Registration and Notification notified as 
G/TBT/N/CHN/1454,  which was published as final on 12 January 2021. United States' comments on  
these notifications, and G/TBT/N/CHN/1527  on toothpaste were submitted to China through the US 
Enquiry Point on 14 January 2021. The United States notes the new language on intellectual property 
(IP) protections in Article 55 of the Administrative Measures, stating that the Natio nal Medical 
Products Administration (NMPA) shall not, with some exceptions, disclose confidential business 
information, or trade secrets submitted by a registration or notification applicant. We ask that China 
please confirm if this provision includes when  these types of information are submitted by local 
agents in accordance with Article 8.  
2.3.  We remain deeply concerned however that companies' intellectual property is still at risk, due 
to the large number of people who may have access to it. Article 55 sugge sts that companies' 
registration and notification documentation may be shared with the medical products administration 
departments of provinces, autonomous regions, and municipalities where products and ingredients 
are filed; professional technical institu tions and their staff; and potentially others who participate in 
the review. Further, the requirement that local agents file all products and ingredients, and are 
responsible for the veracity of the filing and product safety, may result in these agents als o having 
access to companies' intellectual property. Could China confirm that any entity or individual that has 
access to these types of information will be subject to Article 55's non -disclosure requirements? The 
extent of the information that companies a re required to provide under the measures notified in the 
aforementioned notifications is not appropriate for cosmetic products, which are relatively low risk; 
we note that the approach China has taken is similar to what would be required for drugs and med ical 
devices. The information requirements may also create significant and unnecessary obstacles to 
international trade by increasing the registration and filing costs for cosmetics companies. We 
therefore ask that China pare back the information that comp anies are required to provide in pre -
market product and ingredient filings via the requirements in these technical regulations with only 
information that is necessary for the legitimate objective of China's regulatory authority with respect 
to the product at issue.  
2.4.  We are also highly concerned by Article 19 of the measure notified in G/TBT/N/CHN/1526 , 
which requires that companies publicly disclose proprietary test methods and results used to validate 
their product claims on NMPA's website. The information that will be posted on t he website, as 
described in Annex 3, is extremely detailed and includes companies' trade secrets and CBI. We again 
ask that NMPA remove Article 19 and Annex 3. We note that the public has many means to engage 
companies when they have questions on product c laims. We again urge China to engage directly 
with the United States and US industry to identify a viable means for US companies to demonstrate 
conformity with CSAR  and the implementing measures through compliance with Good Manufacturing 
Practices (GMP), w hich do not require animal testing. A regulator -issued GMP certificate may be an 
unnecessary obstacle to international trade, as GMP certificates issued by third parties use the same 
 
2 For previous statements follow the thread under ID 665. G/TBT/M/83  
 
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  requirements as GMP certificates issued by regulators. The final version of G/TBT/N/CHN/1454  
stipulates that the measure will go into effect on 1 May 2021. We ask that China delay 
implementation of the measure until China addresses Member concerns with these measures, and 
consults with industry on a reasonable implementation timeline.  
2.5.  The representati ve of Australia  provided the following statement. The Australian Government 
has submitted written comments to China on notifications G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525 , 
G/TBT/N/CHN/1526 , G/TBT/N/CHN/1527  and other  previous draft implementing regulations relating 
to China's Cosmetics Supervision and Administration Regulation (CSAR). Could China please advise 
when the draft regulations referred to in G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525 , 
G/TBT/N/CHN/1526  and G/TBT/N/CHN/1527  are to be finalized and begin operating? We would also 
welcome a response from China on h ow it plans to take account of the comments of other WTO 
Members prior to the entry into force of these regulations. For example, will China issue revised 
drafts prior to these regulations entering into force? While Australia is pleased that China is looki ng 
to provide alternatives to mandatory animal testing for imported cosmetics, we are also mindful that 
such alternatives should not in themselves raise new barriers that constitute an unnecessary impact 
on trade.  
2.6.  Australian cosmetics businesses have conc erns that the measures outlined in these four draft 
regulations, combined with the CSAR and previous draft cosmetics regulations released by China for 
comment in 2020, will introduce new and burdensome measures that will impact on their trade to 
China. Som e key concerns include the requirement for government certification of Good 
Management Practice (GMP) of cosmetics production facilities, requirements to register and certify 
low-risk cosmetic products even when these include already approved ingredients, restrictive testing 
requirements and requirements for businesses to provide commercially sensitive information. 
Australian industry is also concerned that China's information requirements are excessive for 
certifying production facilities, products and ing redients, and for registering and filing cosmetics for 
sale in China. These overly burdensome information requirements would compromise the intellectual 
property of businesses. The Australian Government would welcome the opportunity to work with 
China and discuss in more detail to exchange information on our respective Health regulatory 
systems, including our respective systems for cosmetics regulation and GMP certification.  
2.7.  The representative of the Republic of Korea  provided the following statement. Korea would like 
to support the delegations of the United States and Australia. Korea welcomes the series of measures 
that support the cosmetic regulatory framework following the implementation of the CSAR. 
Considering th e trade implications of the regulations, Korea has continuously engaged in the 
regulations of China on cosmetics and provided comments through bilateral and multilateral 
channels. However, the recent regulations  of China on cosmetics ( G/TBT/N/CHN/1526 , 
G/TBT/N/CHN/1525 , G/TBT/N/CHN/1524 ) continue to include the concern s that Korea has raised. 
Thus, Korea would like to reiterate our concerns regarding the Regulations, including but not limited 
to the following concerns. First, the Regulations stipulate that a party who exports cosmetics to 
China is required to specify th e manufacturers and quality data of all ingredients of their products in 
the application. Unlike other countries, however, the Regulations of China require disclosing more 
information than necessary to secure the safety and quality of products and to regul ate the market. 
Since such information contains a number of trade secrets or undisclosed business information, 
Korea would like to request China to explain the justification for such requirement. Specifically, 
according to Appendix 12 to 16 in the Regulati ons, a party is required to submit information on 
safety profile and standard operating procedures, which have to describe manufacturing processes 
and control standards in detail. Such information, however, potentially contains commercially 
sensitive infor mation. Korea would like to recall that trade secrets or undisclosed business 
information should be respected in a manner that legitimate commercial interests are protected.  
2.8.  Second, according to the Regulations, the test results for the registration must b e issued by 
the testing laboratories accredited by the China Metrology Accreditation (CMA). Korea would like to 
request China to accept the test results performed by laboratories outside China that comply with 
Good Clinical Practice (GCP) or Good Laborator y Practice (GLP) in applying for cosmetic registration 
in China. Third, pursuant to Article 13 of Specifications for Registration and Filing of New Cosmetic 
Ingredients, a party who exports cosmetics to China is required to provide evidence which proves 
that their test results are equivalent to the results of in vivo  test method, or animal testing, when 
using alternative test methods. Korea requests that alternative test methods that are recognized by 
international organizations such as OECD be accepted. Fo urth, Korea calls on China to maintain its 
current regulation on the labelling of ingredients in cosmetics. According to the new Regulation, all G/TBT/M/83  
 
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  ingredients present at a concentration of 0.1% or more must be declared in the label, and ingredients 
at a conc entration of less than 0.1% are declared as "and other ingredients ". In many countries, 
however, cosmetic ingredients are declared only when they are present at a concentration of 1% or 
more. Korea is concerned with China's requirement as it is inconsisten t with international practices. 
We would like to request China to exempt the labelling of the ingredients that are used during 
manufacture but present only at an insignificant level and not having any functional effect in the 
finished cosmetics.  
2.9.  Korea woul d like to kindly ask China to notify all of its next steps in the development of the 
Regulations and to provide time frames for the publication of the final Regulations and their entry 
into force. We also call on China to grant a reasonable transitional pe riod for the industry to prepare 
to comply with the new requirements according to Article 2.12 of the TBT Agreement. Considering 
the aforementioned concerns, Korea urges China to take into account Article 2.2 of the TBT 
Agreement when drafting regulations,  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 
unnecessary obstacles to international trade. We request China to consider Korea's comments and 
look forw ard to receiving a response from China.  
2.10.   The representative of Japan  provided the following statement. Regarding China's 
implementing regulations of "Cosmetics Supervision and Administration Regulation ", we appreciate 
that China provided the opportunity to provide comments to the WTO/TBT notification. As we have 
noted in the comment to WTO/TBT notification, Japan would like to express its following concerns. 
Regarding article 25 (II) (Product category) of "Specifications for Cosmetics Registration and Filing  
(Draft for Comments) ", Japan would like to request that China clarify the rule for a product with 
multiple efficacies. Since the majority of cosmetics have multiple efficacies, Japan requests that 
rules for the indication of each product category will not  become more restrictive than necessary. 
Annex 5 "Information Form for Registration or Notification of New Cosmetic Ingredients " has an item 
to report whether it contains nano ingredients and Annex 7 provides definition of such. Article 27 of 
"Specificatio ns for Cosmetics Registration and Filing (Draft for Comments) " provides the rule for 
naming of nano ingredients in product formulas for registration or filing and also Article 27 of 
"Standards of Information File for Toothpaste Notification (Draft for Comm ents)" provides the rule 
for naming of nano ingredients in the product formulation table. Japan considers that a more detailed 
and concrete standard is necessary to judge which ingredients fall under the definition of nano 
ingredients. In addition, Japan w ould like to request that the standard will be formulated in a way 
that reflects international trends and comments from all stakeholders.  
2.11.   Article 27(II) of "Specifications for Cosmetics Registration and Filing (Draft for Comments) " 
and Article 27(II) of "Standards of Information File for Toothpaste Notification (Draft for Comments) " 
provide that the ingredient quality and safety information document issued by the ingredient 
manufacturer shall be submitted during registration or filing process. Therefore, w hen registrants or 
filers change their ingredient manufacturer, it is necessary to submit the document again even if the 
quality and safety are the same. This causes unnecessary burdens for registrants or filers. Since 
registrants or filers are responsible  for quality and safety of the final products, excessive demand 
for proof of quality and safety of ingredients is not necessary. Therefore, the same as in international 
practice, Japan considers that the information of ingredients should be submitted when requested 
by the NMPA  after launch, not at the time of registration or filing. Regarding Article 31 (II) 
(Exemption from submitting toxicological testing documents) of "Specifications for Cosmetics 
Registration and Filing (Draft for Comments) ", since the l egal system and enforcement system for 
cosmetics differ by country or region, some countries may not have the relevant authority. 
Therefore, Japan would like China to accept a certification document on the quality management 
system or good manufacturing pr actice qualification which is issued by an authorized international 
organization or an industry association which is authorized to issue the certifications by government 
agencies of the country or region where the registering or filing company is located, instead of a 
national institution.  
2.12.   Regarding the test of freckle -removing/whitening products, Japan would like to request that 
China adopt the approach of Read -Across that was provided in article 16 (freckle -
removing/whitening effect cross -reference) of "Specifications for Cosmetic Efficacy Claim Evaluation 
(Draft for Comments) " last September. Freckle -removing/whitening is affected by active ingredients 
included in the cosmetics and the Read -Across approach will help shorten the application to 
permission p rocess. Annex 1 of "Standards of Information File for Toothpaste Notification (Draft for 
Comments) " provides a catalogue of toothpaste efficacy classifications (toothpaste positive list). G/TBT/M/83  
 
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  Since new efficacies might be added in the future, Japan would like to request clarification of the 
concrete update process of the catalogue. It is also not clear how to deal with the safety monitoring 
of new toothpaste ingredients. Like Article 26 of "Provisions for Cosmetics Registration" and Article 
27 of "Specification s for Cosmetics Registration and Filing (Draft for Comments )" on how to deal 
with the new cosmetic ingredients, Japan would like to request clarification with respect to new 
toothpaste ingredients as well. Finally, as the "Cosmetics Supervision and Adminis tration Regulation " 
and its implementing regulations will cause great change, a reasonable transition period is necessary 
to ensure business continuity. Japan would like to request that China provide an adequate grace 
period, at least one year after promul gation of all relevant regulations, in order to allow time for 
producers to adapt to a new cosmetic regulatory system.  
2.13.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Japan, Korea, the United States, Australia and New Zealand. The 
notified drafts contain rules for the implementation of the new Cosmetics Supervision and 
Administration Regulation (CSAR). The EU is of the opinion that the clear steps outlined in the 
implementing rules f or product and ingredient registration can lead to a faster and more efficient 
registration and filing mechanism. In particular, the obligation 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, such as the disclosure of "the source of the ingredients and their quality 
specifications ", go beyond the CSAR principle s in a way that would create problems for the operation 
of cosmetic companies, including both domestic manufacturers and importers. The EU would like to 
point out that this kind of information, on a raw -material -by-raw-material basis is commercially 
sensit ive and touches on intellectual property rights of the companies involved (suppliers and 
cosmetic manufacturers). Mandatory disclosure of this information in the registration and filing 
process is therefore a significant concern for the EU. The EU is of th e opinion that including this kind 
of information, as part of the pre -market registration or filing dossier, is not necessary to ensure 
consumer safety and traceability of the ingredients used in cosmetics.  
2.14.   The EU has noted that no specific transition peri ods are indicated in the notified draft 
measures, however, they will be a crucial "workability" factor for the successful implementation of 
CSAR and its implementing legislations. Given the amount of changes to industry practice that this 
implementing legi slation will induce, the EU is of the opinion that a differentiated approach is needed 
between new products (two years) and products on the market (three years). This will avoid a 
situation (like in 2009) when product supply was interrupted for an extended  period of time due to 
insufficient preparation time for both industry and supervision authorities. In addition, some 
requirements are not entirely clear from the notified text and the EU would appreciate further 
clarification in particular on the concerns  raised by the EU in its comments sent to the WTO in 
January 2021.  
2.15.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
China's endeavours to modernise its regulatory system for cosmetics and also welcomes the 
opportunit y to comment on China's proposed cosmetics measures notified under 
G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525 , G/TBT/N/CHN/1526  and G/TBT/N/CHN/1527 . While we 
welcome the direction to improve safety and quality assurance, New Zealand would like to encourage 
China to ensure that facilitation of trade is considered in the design and implementation of the 
regulations. New Zealand understands that under the measures, non -animal tested cosmetics are 
able to enter China's market only on the basis that regulator -issued GMP certification accompanies 
these products. Like others, New Zealand is concerned, however, that  the measures do not provide 
for non -regulator issued GMP certification. New Zealand would like to better understand what 
consideration China has accorded to less trade -restrictive alternatives for those Members that do 
not have a domestic mechanism for re gulator -issued GMP certification. To further advance trade 
facilitation, New Zealand encourages China to accept non -regulator issued GMP certification for 
cosmetics imports, without requiring mandatory animal testing.  
2.16.   New Zealand requests that China also p rovide further clarity on the proposed testing 
measures. In particular, we encourage China to clarify in the regulation that test reports can be 
accepted from accredited laboratories situated outside of China. If test reports from internationally 
accredite d bodies outside of China are not accepted, then this will create trade barriers for exporters 
who send products to China as well as multiple other markets. Building in flexibility to accept test 
reports from accredited laboratories outside of China would be trade facilitative and in accordance 
with international best practice.  G/TBT/M/83  
 
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  2.17.   In response, the representative of China  provided the following statement. Product formula, 
production process and other materials of cosmetics as health -related products are importa nt 
evidence for carrying out safety technical review of products. It is also a common rule of Members 
to require registrants and filers to submit safety -related materials so as to carry out the safety 
review of health -related products. Safety materials rel ated to products submitted by companies are 
not information to be disclosed by the relevant authorities. Disclosure of government information is 
a measure for the Chinese Government to accept public supervision and guarantee the public's right 
to know. In accordance with the Regulations of the Government of the People's Republic of China on 
Information Disclosure, an administrative agency shall not disclose government information 
involving trade secrets, personal privacy and other information that will caus e damage to the 
legitimate rights and interests of a third party. NMPA has also fully considered reasonable 
suggestions from parties, and added relevant provisions on confidentiality of the registration and 
filing materials in the Provisions for Cosmetics Registration.  
2.18.   According to scientific research data, there are some differences in skin texture between 
different races. During its supervision, NMPA also found that the sunscreen index reports issued by 
some laboratories are significantly different to the  results obtained by Chinese laboratories based 
on tests on Chinese subjects. To protect the legitimate rights and interests of Chinese consumers, 
ensure the accuracy of test results, etc., NMPA requires the efficacy testing of special cosmetics in 
cosmeti cs registration and filing inspection institutions. However, foreign -funded inspection 
institutions are not prohibited from serving as cosmetics registration and filing inspection 
institutions. At present, many laboratories of foreign -funded inspection ins titutions in China have 
obtained the CMA certification of cosmetics and undertaken cosmetics registration and filing 
inspections. As to the reports from overseas institutions being accepted for evaluating the 
sunscreens, freckle -removing, whitening and ant i-hair loss products, the Draft Guidelines for Claims 
Efficacy Evaluation has actually set reasonable evaluation requirements according to the categories 
of cosmetics efficacy claims. For most efficacy claims with low safety risks, no requirements have 
been imposed on the evaluation methods and evaluation test institutions, while it is only required 
that the test results shall be issued by the registration and notification inspection institutions for the 
efficacy evaluation test of some special cosmetics wi th relatively high risks.  
2.1.2.2   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1048 , 
G/TBT/N/SAU/1166 , G/TBT/N/SAU/1166/Corr.1  (ID 6663) 
2.19.   The representative of Japan  provided the following statement. Japan expresses the  following 
concerns regarding the draft Technical Regulation for Restriction of Hazardous Substances in 
Electrical and Electronic Equipment (EEE). The proposed draft technical regulation (TR) stipulates 
type approval as conformity assessment procedures, which includes either a) examining a complete 
sample of the product or b) reviewing the TR and evidence, and examining one or more of risky 
elements of the product. In each case, Japan understands that the test is require d to be conducted 
for each homogeneous material. For option a), in many cases, thousands to tens of thousands of 
homogeneous materials are contained in one EEE. Based on this feature, mandatory testing for all 
homogeneous materials requires a tremendous in crease in workload and cost. Therefore, it is not 
feasible. On the other hand, regarding option b), when the test is performed on limited parts only, 
it cannot be the conformity assessment for the entire product. In order to resolve the situation, 
Japan wo uld like to request that the manufacturer's self -declaration of conformity based on the 
international standard IEC63000 be accepted as a systematic approach to assure compliance for all 
parts. Many regulations restrict hazardous substances in other countri es and allow exemptions of 
substances for certain uses, when they do not have alternatives based on scientific and technical 
studies. On the other hand, since the proposed TR does not have such exemptions, it may be 
technically impractical to fulfil the re quirements. Japan would like to request that the technical 
regulation be harmonized with international standards and practice and it not be more trade -
restrictive than necessary to fulfil a legitimate objective.  
2.20.   The representative of China  provided the fol lowing statement. Regarding testing report 
requirements described in notified regulation, in case test data is required, it is important to note 
that a full product test report means that companies need to test every single component, at the 
homogenous mat erial level. Testing all homogeneous materials fractions is extremely time - and 
resource -consuming. Instead, as described in IEC 63000, manufacturers work with their supply 
 
3 For previous statements follow the thread under ID 666. G/TBT/M/83  
 
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  chains to manage compliance and compile technical documentation as evidence of comp liance. This 
is an internationally implemented and accepted process to restrict the hazardous substances. 
Therefore, it is highly recommended that the conformity assessment procedure is based on 
submission of a declaration of conformity provided by manufac turers, and harmonized with current 
industry practice globally. The preparation of the technical documentation is fully aligned with IEC 
63000:2018 on "technical documentation for the assessment of electrical and electronic products 
concerning the restrict ion of hazardous substances". Some Members provide exemptions for the 
cables and spare parts for the repair, reuse, updating of functionalities or upgrading of capacity of 
the equipment which have been on the market before the Regulation. The purpose of th ese is to 
extend the lifetime of the equipment and it is beneficial to the environment. It is recommended that 
Saudi Arabia adds the spare parts and cables for the repair, the reuse, the updating of functionalities 
or upgrading of capacity of the equipment  which were placed on the market before the notified 
regulation enters into force to the exempted equipment list. Considering the impact of COVID -19 on 
the global supply chain, China suggests the transitional period for the implementation of the 
regulation s is extended from six months to 18 months, in order to provide sufficient time for 
manufacturers to replace raw materials and upgrade products in accordance with regulatory 
requirements.  
2.21.   The representative of the United Kingdom  provided the following stat ement. The United 
Kingdom would like to thank the Kingdom of Saudi Arabia for the opportunity to submit written 
comments on the notification G/TBT/N/SAU/1166 , which sets out technical requirements for the 
restriction of hazardous substances in electrical and electronic equipment.  Due to the complexity of 
the sector covered by these measures, and given the nature and structure of manufacturing activity 
and global supply chains for these goods, the United Kingdom encourages alignment with 
international best practices in the relevant  regulatory requirements, wherever possible. This 
facilitates global trade in these particular goods and their components, and reduces the risk of 
potential barriers to trade. With regards to this measure, it is our view that it could have a significant 
impact on imports from the United Kingdom to the Kingdom of Saudi Arabia. We share some of the 
concerns raised by other Members on this notification. In particular, a type -approval conformity 
assessment procedure diverges from international best practice. We  would appreciate further 
discussion on the viability of a system of manufacturer self -declaration of conformity aligned to the 
appropriate relevant international standard.  
2.22.   The United Kingdom is also concerned that the transition time between adoption and entry 
into force is too short for industry to adjust to the conformity assessment procedures foreseen in 
the measure. We understand that the Kingdom of Saudi Arabia is considering an extension to the 
transition period, which we welcome. We believe that a t ransition period of at least 18 months from 
the publication of this technical regulation would allow for a smooth and effective implementation of 
the new requirements. The United Kingdom, observing that the measure was notified under 
Article  2.10 of the WT O TBT Agreement as urgent, seeks further clarity on the reasons for this 
urgency. The United Kingdom greatly appreciates our recent constructive engagement on this 
matter, and the Kingdom of Saudi Arabia's openness to collaborate. We look forward to contin ued 
discussions in this respect.  
2.23.   The representative of the United States  provided the following statement. The United States 
supports the interventions of other Members on the Kingdom of Saudi Arabia's (KSA) emergency 
notification of its "Technical Regulat ion for the Restrictions of Hazardous Substances (RoHS) ", which 
noted an implementation date of 7 January 2021. US industry provided comments on Saudi Arabia's 
notification on 30 December 2020 through the United States Enquiry Point. US industry's most 
significant concerns about the KSA RoHS were potential deviations from international standards, 
lack of clarity regarding the scope of the regulation, and inconsistencies between the KSA RoHS 
requirements and the EU RoHS requirements, from which the KSA has m odelled its regulation. The 
KSA RoHS deviates from the EU RoHS conformity assessment requirement, changing from self -
declaration to a certificate of conformity, yet fails to clearly specify how manufacturers can 
demonstrate conformity. The United States sh ares concerns with the draft regulation, particularly 
regarding the conformity assessment regime  and the lack of clarity regarding scope and product 
exemptions. Given the 30 -day comment period and US industry concerns, on 3 February, the United 
States requ ested Saudi Arabia extend the comment period to 5 March 2021. The United States 
intends to submit comments on the draft measure. We request SASO take comments into 
consideration as it finalizes the regulation.  G/TBT/M/83  
 
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  2.24.   We understand there have been revisions to the  draft since it was notified, and request that 
the current version be re -notified with an additional comment period as recommended in the TBT 
Committee's Coherent Use of Notification Formats. Does Saudi Arabia have an update on when it 
intends to finalize the regulation and how much time will be provided before it enters into force? We 
request a reasonable interval for implementation of no less than six months to allow time for industry 
to adapt to these new certification requirements. The testing and facto ry certifications laid out in the 
draft regulation raise concerns regarding feasibility, and potentially create unnecessary obstacles to 
trade. The United States requests that these requirements be clarified and avoid creating any 
duplicative or unnecessar y conformity assessment requirements.  
2.25.   The representative of Canada  provided the following statement. Canada took note of Saudi 
Arabia's notification G/TBT/N/SAU/1166  and subsequent corrigendum issued 1 and 4 December 
2020, regarding the Technical Regulation for Restriction of Haz ardous Substances, issued by the 
Saudi Standards, Metrology and Quality Organization. While Canada supports WTO Members' efforts 
to protect human health and safety, as well as the environment, by regulating to ensure that 
hazardous substances are not prese nt above certain levels in consumer products such as electrical 
and electronic equipment, Canada would like to raise the following concerns related to this measure. 
Canada is concerned that Saudi Arabia failed to allow WTO Members and stakeholders the 
appropriate period of time of at least 60 days to review the measure and provide comments. In 
addition, the proposed date of adoption of the measure (7 January 2021) was only seven days after 
the closure of the allowed period for comments, which in Canada's vi ew does not provide sufficient 
time for Saudi Arabia to fully consider the input and comments receive to inform the development 
of the measure.  
2.26.   Canada also questions the rationale behind Saudi Arabia's justification that the products 
covered by the regulat ion are "high risk " and that the measure needed to be developed and adopted 
on an emergency basis. Could Saudi Arabia provide more details as to what urgent situation in late 
November/early December prompted the development of the measure covering such a w ide area of 
products? With respect to the substance of the measure, Canadian stakeholders have noted concerns 
regarding testing for compliance, which defer from the widely accepted EU RoHS Directive. We 
understand that under the measure, testing would need  to be done through the Saber  system, as 
opposed to the RoHS self -certification scheme. We further understand that the required testing 
would need to be performed at one of Saudi Arabia's Notified Bodies – can Saudi Arabia confirm this 
information? We welc ome any further information and clarification on the measure that Saudi Arabia 
can provide to the Committee today.  
2.27.   The representative of the European Union  provided the following statement. The European 
Union would like to join the other delegations (Japan , China, the UK, the US and Canada) and express 
concerns regarding the draft Technical Regulation for Restriction of Hazardous Substances, notified 
by Saudi Arabia on 1 December 2020. The European Union regrets that Saudi Arabia only provided 
30 days for c omments to the WTO Members. It appears from the information published on the 
website of the Saudi Standards, Metrology and Quality Organisation (SASO) that the technical 
regulation was adopted in January 2021. Could Saudi Arabia clarify the status of the n otified text 
and the expected date of its publication and entry into application? Due to concerns expressed by 
EU industry, the EU would like to ask Saudi Arabia whether written comments could still be sent.  
The European Union would like to raise the follo wing points . The notified text requires a mandatory 
third party conformity certificate, issued by a body approved by SASO and based on test reports 
from an accredited laboratory.  This would deviate from common international practice, followed also 
by the E uropean Union, which relies on first -party declaration of conformity drawn up by the 
manufacturers or their authori zed representatives and would bring significant hurdles on businesses . 
The EU therefore invites Saudi Arabia to consider limiting the conform ity assessment requirements 
to the submission of a first -party declaration of conformity to be provided by manufacturers. In 
addition, the EU would like to ask whether conformity assessment bodies not established in Saudi 
Arabia can be approved by SASO and  under which conditions.  
2.28.   The EU also invites Saudi Arabia to provide for a sufficiently long transition period that would 
ensure a smooth implementation and adaptation for economic operators. T he proposed six -month 
transitional period would not allow compa nies sufficient time to prepare for the conformity 
assessment procedure proposed in the notified text, which differs significantly from European 
practice. In that respect, a deadline of at least 18 months would be necessary.  Notification 
G/TBT/N/SAU/1166  provides under point 4 a list of HS codes of products covered by the draft 
technical regulation. The EU would like to ask whether this list of products under the scope of the G/TBT/M/83  
 
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  draft regulation is exhaustive and whether the same products are covered as in A nnex I to the 
European Directive 2011/65/EU on the restriction of the use of certain hazardous substances in 
electrical and electronic equipment  (EU RoHS) and whether the restricted substances and their 
maximum concentration values tolerated by weight in h omogeneous materials are identical to those 
in Annex II to EU RoHS.  The EU would like to ask whether the exemptions in the notified text are 
the same as the exemptions included in the Annexes III and IV of the EU RoHS. The EU would also 
like to know whethe r Saudi Arabia plans to align to the future exemptions under the EU RoHS.  
2.29.   Finally, the EU would like to know what is the relation of this notified text to the draft GCC 
Technical Regulations for the Restriction of the use of certain Hazardous Substances in  electrical and 
electronic equipment, notified to the TBT Committee in March 2018 ( G/TBT/N/SAU/1048 ). What is 
the status of the GCC draft technical regulation and the timeframe for its adoption? When adopted, 
will Saudi Arabia replace its national rules with the GCC ones? The EU would like to invite Saudi 
Arabia to promote the GCC harmoni zed requirements, which should also guarantee their uniform 
application and a mutual recognition of conformity assessment results in the region. The European 
Union is available to discuss this iss ue with Saudi Arabia bilaterally.  
2.30.   The representative of Switzerland  provided the following statement. Switzerland would like to 
support the interventions made by previous speakers on the Kingdom of Saudi Arabia's Technical 
Regulation for limiting and restr icting hazardous materials in electrical and electronic equipment. 
While we share the Kingdom of Saudi Arabia's legitimate objective to protect the environment and 
public health and safety, Switzerland is concerned that these requirements may have a negati ve 
impact on trade for a wide range of products. We note in particular that the testing and certification 
requirements seem to deviate from the widely internationally accepted RoHS requirements, which 
are also used in Switzerland and elsewhere in Europe. W e encourage the Kingdom of Saudi Arabia 
to consider less trade -restrictive alternatives and take these practices into account. Switzerland 
thanks the Kingdom of Saudi Arabia for its response on our written comments and looks forward to 
further cooperation on this topic.  
2.31.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia would like to express appreciation on the concerns addressed by the UK, 
Japan, China, Canada, the US, the EU and Switzerland for th eir valuable comments on the urgent 
notification issued 1 and 4 December 2020 regarding the Technical Regulation for Restriction of 
Hazardous Substances. Moreover, Saudi Arabia is aiming at protecting human health and safety, 
and the environment, by regula ting to ensure that hazardous substances are not above certain levels 
in consumer products such as electrical and electronic equipment , as implemented by  WTO Members. 
Consequently, Saudi Arabia would like to clarify the following: Saudi Arabia submitted un der the 
emergency/urgent notification provisions of the TBT Agreements (Article 2.10) in response to the 
pressing health problems posed by non -conforming products detected by National Surveillance 
Authorities. In addition, WTO Members can develop measures directly and immediately notify the 
WTO with such regulations, without providing the usual 60 -day comment period (or six -month 
transition period prior to entry into force). SASO notified the measure on 4 December 2020 and 
approved it on 28 January 2021 , which is considered sufficient  under the emergency/urgent 
notification. However, Saudi Arabia takes into consideration that emergency measures still need to 
comply with the other provisions of the TBT Agreements, such as avoiding discriminatory or 
unnecessar y barriers to trade, ensuring a scientific basis for measures, and harmonizing with 
international standards. The TBT notification alert system, ePing, facilitates swift access to these 
notifications by both public and private stakeholders so that they can react and adjust as necessary 
to the requirements and procedures under development. In regard to the proposed date of adoption 
of the regulation mentioned in the notification, this has been amended. Saudi Arabia is fully 
considering the inputs and welcome all comments, where they will be considered in developing our 
technical regulations.  
2.32.   Saudi Arabia has aligned the amended version of the Saudi Technical Regulation with global 
practices such as EU RoHS Directive, taking into consideration compatibility wit h national deviations 
such as conformity assessment schemes. As for the conformity assessment procedures, SASO has 
chosen to apply the international standard ISO/IEC 17067 for granting certificates of conformity 
(Type Approval) to products issued by Notifi ed Conformity Assessment Bodies. Within the framework 
of SASO, conformity assessment activities (certification, audit and inspection, and testing activities) 
have been developed to raise the level of quality in the national industry and the safety of impor ted 
goods presented in the Saudi market. By accepting conformity assessment bodies under the various 
conformity assessment activities, this process aims to ensure the efficiency of the outputs of the G/TBT/M/83  
 
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  accepted conformity assessment bodies within the systems  and requirements of the technical 
regulations, according to the scopes of acceptance of these bodies. Therefore, SASO chose to engage 
a notified third party responsible for granting conformity certificates in the non -existence of a legal 
representative fr om the foreign manufacturers. Having said that, SASO reserved its right to enforce  
the technical regulation for Restriction of Hazardous Substances on the specified date (six months 
after publishing in the official Gazette) and during this period SASO is c ommitted to review some 
details of these procedures of conformity assessment to extend the validity of test reports.  
2.1.2.3   India – Draft Food Safety and Standards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 6674) 
2.33.   The representative of the United States  provided the following statement. The United States 
has several questions and concerns regarding India's draft amendment "Registration and  Inspection 
of Foreign Food Manufacturing Facilities " to its Food Safety Standards (Import) Amendment 
Regulation, 2020, notified to the WTO TBT Committee as G/TBT/N/IND/180 . In response  to India's 
notification, we submitted comments on 22 January 2021. This draft regulation leaves many 
unanswered questions for foreign food manufacturing facilities, competent authorities, and other 
stakeholders. Today we will discuss only a handful of tho se questions. The draft regulation states 
that India may identify categories of "risk" for food products "from time to time… for which inspection 
or audit of foreign food manufacturing facilities producing such categories of foods shall be 
mandatory. " We are concerned about the open -ended nature of the scope of this proposed technical 
regulation. Please clarify how India will determine the specific "risk" for food product categories 
imported into India, and how this information will be communicated to the p ublic. Will India publish 
updated lists of such food product categories? Will stakeholders have an opportunity to submit 
comments on these categories?  
2.34.   Will Indian domestic facilities manufacturing categories of food products determined to be of 
a sufficien t "risk" also be required to apply for FSSAI registration? In addition, could India please 
clarify what is meant by "from time to time "? Does India intend to undertake regularly scheduled 
systemic reviews of food categories? Will these systematic reviews a nd changes to the regulatory 
system be notified to the WTO for a notice and comment period? With regard to the registration 
process, will India require paper copies of applications, or will foreign manufacturing facilities be 
allowed to submit electronic v ersions of these documents? If applications cannot be submitted 
electronically, India should consider the burden for competent authorities involved in reviewing the 
documentation, and whether the reviews can be carried out in a timely manner. Finally, we a sk that 
India please provide clarity regarding its ambiguous inspection and audit procedures, including the 
frequency at which India anticipates to conduct such audits, who is financially responsible for a food 
facility's audit expenses and a proposed time line when audits are first required to take place. We 
look forward to India's consideration of and response to the United States comments.  
2.35.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Draft Food Safe ty and Standards (Import) Amendment Regulation, notified by the 
Government of India on 25 November 2020 to Members of this Committee in document 
G/TBT/N/IND/180 . The Government of Mexico would be grateful if the delegation of India could 
provide more clarity on the products subject  to this Regulation and confirm  whether alcoholic 
beverages are part of this list.  We understand that the Government of India will determine, on the 
basis of risk, the categories that are subject to the Regulation . In this regard, we would also welcome 
information on the procedure that will be followed for such a determination and on when the 
Government of India will announce the categories for which the procedure must be carried out.  The 
procedure for registering and inspecting food manufacturing facilitie s abroad has caused doubts and 
uncertainty for the Mexican industry. It is therefore important to have information on how these 
processes will be conducted. We also consider it important for the Government of India to share 
information on how this procedur e is necessary to achieve the objective pursued, and whether 
consideration was given to alternatives to this procedure which would be less restrictive for 
importers.  In light of the above, we would be grateful if the delegation of India could share 
informa tion on the Regulation, the manner in which it will determine the product categories or types 
of products that will be subject to compliance, as well as information  how the on -site inspections or 
visits will be conducted, and o n the entry into force and th e current status of this Regulation.  The 
 
4 For previous statements follow the thread und er ID 667. G/TBT/M/83  
 
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  delegation of Mexico thanks the delegation of India for giving its consideration to this statement and 
the requests made therein.  
2.36.   The representative of Australia  provided the following statement. Australia recognize s the 
right of the Indian Government to take measures necessary to protect public health. Australia 
provided comments on India's draft amendments and provided a written submission within the TBT 
notification comment period. Australia wishes to emphasize th e importance of compliance with WTO 
obligations, in particular that measures be implemented in a way that is no more trade -restrictive 
than necessary. Australia is concerned that as drafted, aspects of the proposed Regulations are more 
trade restrictive th an necessary to fulfil India's food safety objectives. Australia believes the 
Regulations will create an additional burden on both producers and exporters in Australia, and cause 
disruption for Indian importers and customers. Clarity on the categories of f ood manufacturers and 
the basis for determining when the Regulation applies is lacking. Australia is concerned that the 
proposed measures may not be linked to the risks posed by the imported food. Australia welcomes 
India's consideration of our comments an d looks forward to India's response and continued 
engagement on the issue. Australia is happy to work with India to support a more risk -based 
approach to food safety.  
2.37.   The representative of Canada  provided the following statement. Canada welcomes the 
opport unity to comment on India's recent notification amending its Food Safety Standards (Import) 
Regulations pertaining to the registration, inspection and/or audit of foreign food manufacturing 
facilities producing food products destined for India. While Canad a recognizes India's right to take 
necessary measures to protect public health and safety, we are concerned that these new 
requirements will create an unpredictable and disruptive trading environment. There are a number 
of ambiguities in India's proposed o rder and details on its implementation elements such as target 
commodities, source -countries, implementation plan, audit rates, compliance actions and appeals, 
are lacking or insufficient. Specifically, it is unclear what criteria would be used, what circu mstances 
would instigate an audit or an inspection of a foreign manufacturing facility or how such actions will 
be taken given the ongoing travel restrictions resulting from the pandemic. In addition, further 
information is required on the process by which  "auditing agencies" will be recognized by the Food 
Authority and whether competent foreign authorities would be eligible for this designation. Detailed 
comments, questions and concerns were submitted to India's Enquiry Point on 21 January 2021 in 
an effor t to gain a better understanding of the scope and intended objective of this order. Canada 
looks forward to receiving a timely response. In closing, given that India's proposed regulation 
covers food safety measures aimed at protecting human health and saf ety, Canada respectfully 
requests that it be notified to the WTO SPS Committee in order to provide an opportunity for 
Members to comment.  
2.38.   The representative of Argentina  provided the following statement. We share the concerns 
raised by the different delega tions. Argentina has a number of doubts about giving effect to and 
putting into operation the provisions contained in the draft standard notified in document 
G/TBT/N/IND/180 , particularl y with regard to the products covered and the provisions on 
registration, inspection and audit of exporting establishments.  All our questions have been passed 
to India's TBT Focal Point before the deadline for comments and we look forward to receiving the 
replies and clarifications as soon as possible. We also hope that the provisions contained in the draft 
standard do not become unjustified restrictions on trade, since India is a very important trading 
partner for our country and the agricultural sector is  the main export item.  
2.39.   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 express our support to the co mments made by the United States, Mexico, 
Australia and Canada. Our comments on the proposed measure were sent to India's TBT Enquiry 
Point on 30 December 2020, which sought clarifications from India on a number of implementing 
issues. We appreciate an upd ate of the status of this draft and look forward to a written response 
from India.  
2.40.   The representative of the European Union  provided the following statement. The European 
Union would like to support former interventions and highlight its concern with this Indian measure. 
We sent you written comments and I just want to highlight our main elements of concern: (i) the 
transition period is too short and should be extended to 18 months; (ii) India should further clarify 
the scope of products/food categories; (ii i) a list of low risk products should be defined that should 
be exempted. An example would be wines and spirits due to their inherent stable nature; and (iv) G/TBT/M/83  
 
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  inspections and audit of foreign food manufacturing facilities as well as registration need to be 
clarified and simplified.  
2.41.   In response, the representative of India provided the following statement. Our response is as 
follows. The comments received from various stakeholders are currently being examined.  
2.1.2.4   Kingdom of Saudi Arabia - Air Conditioners - Minimum Energy Performance, 
Labelling and Testing Requirements for Low Capacity Window Type and Single -Split, 
G/TBT/N/SAU/526 , G/TBT/N/SAU/774 , G/TBT/N/SAU/1167  (ID 6685) 
2.42.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of Kingdom of Saudi Arabia to protect the environment and K orean companies are fully 
committed to complying with the regulations of Saudi Arabia. However, Korea would like to make 
some comments regarding this regulation as follows. Firstly, Korea humbly requests that Saudi 
Arabia reconsiders the introduction of th e new regulation, which is "AC setting for partial load 
operation" in Clause 7.4. In accordance with Article  7.4 of standard (SASO 2663:XXXX) notified as 
G/TBT/N/SAU/1167 , the AC setting information for partial load operation test shall be provided both 
on the product packages an d registration system of SASO website. Korean companies are fully 
committed to complying with the new regulations of Saudi Arabia, but they are concerned about the 
possibility of infringement of intellectual property. The partial load operation can be cont rolled only 
through Test Mode. If the information about Test Mode is exposed, other performance tests results 
and control technologies could be disclosed. The exposure of the intellectual property of 
manufacturers is inevitable. Due to the facts mentioned above, when applying for a certification in 
the European Union and the United States, testing bodies do not ask manufacturers for information 
on air conditioner settings for partial load operation. Despite the review, if Saudi Arabia decided to 
introduce a dditional regulation related to the AC setting for partial load operation, Korea would like 
to request that Saudi Arabia consider more reasonable alternatives to avoid the risk of disclosing 
the confidential information of manufacturers. One alternative ma y be that an engineer of the 
manufacturers directly participates in the local testing process to set it up, or that the manufacturer 
provides a method for performing partial load operation without exposing the setting information to 
the outside.  
2.43.   Secondly, Korea would like to request either exempting the certificate renewal or relaxing the 
certificate renewal requirements by allowing the use of test reports submitted for initial certification, 
of products with the same specifications as the original certifie d product, which require energy 
efficiency regulations including air conditioners. In most countries such as the European Union and 
the United States, Korea, and UAE, certificate renewal is not required unless a change has been 
made to the product or the r elevant regulation. Especially, for renewing certification in your 
neighbouring countries such as Qatar and Bahrain, manufacturers are permitted to apply for 
certificate renewal using test reports that had been submitted for initial certification, provided  there 
are no changes to their products or related regulations. Currently, Korean manufactures exporting 
their products to Saudi Arabia must renew their energy efficiency certificates every year and take 
product testing again even if the specifications are  same as the original certified products. These 
create administrative burdens and additional costs on the manufacturers and also against 
international common trends. Korea is willing to actively participate in movements of the 
international societies by re inforcing energy efficiency regulations to protect the environment. 
However, Korea thinks that the energy efficiency regulations should be harmonized with the relevant 
international common practices and should not cause excessive burdens on companies.  
2.44.   The representative of China  provided the following statement. It is suggested that Saudi 
Arabia pays attention to the impact of barometric pressure on the cooling capacity of air conditioners. 
The climate in Saudi Arabia is mainly tropical desert. SASO's offic ial lab is located in Riyadh and its 
typical barometric pressure is about 700mmHg (the millimetre of mercury). The test condition at a 
lower barometric pressure shall change the fan speed or system resistance of tested air conditioner, 
which probably cause s deviation of test result if there is no correction for variation. During the 
verification test to the recalled or returned products conducted in China, it is found that the cooling 
capacity of some air conditioners measured at 700mmHg barometric pressure  (without correction) 
and standard barometric pressure (760mmHg) deviates by -4% or more, which is close to or over 
the 5% tolerance that Saudi Arabia allows. To ensure the consistency of testing methods of SASO -
certified air conditioning products between certification test and market supervision test, it is 
 
5 For previous statements follow the thread under ID 668. G/TBT/M/83  
 
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  suggested that Saudi Arabia specifies the barometric pressure when conducting energy efficiency 
tests according to the standards in SASO 2663 and allows the correction to the test results of cooling 
capacity at all kinds of working conditions measured under barometric pressure lower than standard. 
Article 8.1.2 of ISO 5151:2017 which serves as source of SASO 2663 and Article 8.5.4 in American 
society standards of heating, air conditioning and refrigerati on engineers ANSI/ASHRAE 16 -2016 
could be taken as reference for correction methods: the tests shall be conducted at the specified 
temperature conditions with no changes in fan speed nor system resistance, the related test results 
could be corrected for va riations based on the standard barometric pressure of 101.325 kPa (29.92 
in.Hg). The cooling capacity tested below standard barometric pressure 101.325kPa (29.92 in.Hg) 
could be increased 0.24% for each kPa (0.8% for each in.Hg).  
2.45.   In response, the represent ative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia would like to thank the Republic of Korea and China for their valuable 
comments regarding the "Air Conditioners - Minimum Energy Performance, Labelling and Testing 
Requirem ents for Low Capacity Window Type and Single -Split". Since this standard is still at the 
comments review stage, we will discuss these comments deeply with all concerned entities. We will 
provide you with our answers regarding these comments via each Member 's TBT Enquiry Point.  
2.1.2.5   India - Flat Transparent Sheet Glass and Safety Glass (Quality Control) Order , 
G/TBT/N/IND/118 , G/TBT/N/IND/119  (ID 6696) 
2.46.   The representative  of the Republic of Korea  provided the following statement. Korea would 
like to make some comments regarding these regulations as follows. First of all, Korea respects the 
efforts of India to introduce transparent flat glass and safety glass quality control orders (QCOs) for 
the health and safety of Indian people. Furthermore, Korean companies are committed to comply 
with the regulation of th e Indian authority. However, Korean companies has the following difficulties 
regarding the enforcement date of transparent flat glass and safety glass quality control orders, 
2020 of India. The enforcement dates of transparent flat glass and safety glass Q COs are scheduled 
to take effect in 1 March 2021 and 1 April 2021, respectively. However, Korea understands that it is 
difficult for local BIS to provide normal services due to COVID -19. The Korean companies completed 
the certification application in June last year, but additional certification procedures such as factory 
audit have not been conducted yet after the document screening was completed. In particular, if the 
grace period is not extended at a time when the effective date is imminent, it is almost impossible 
to export to India. Therefore, Korea requests that India postpone the implementation of transparent 
flat glass and safety glass QCOs by more than six months or to take alternative measures such as 
temporary factory audit exemption for a limited period, considering the delay in certification process 
due to COVID -19. In addition to this, Korea would like to deliver requests as Korean companies has 
difficulties regarding the scope of safety glass QCO 2020 of India. According to the scope of Indian 
standard IS 2553 -Part 1 (safety glass -specification, Part1: architectural, building and general uses) 
referred by the safety glass QCO, parts and components used in appliances should comply with this 
regulation. However, this standard mainly prescribes test  requirements for the safety glasses used 
in architectures and buildings, so applying this regulation to the glasses used in appliances is not 
appropriate. Therefore, Korea requests India to exclude the application of this regulation for parts 
and componen ts of appliances.  
2.47.   In response, the representative of India provided the following statement. The standards have 
been made mandatory after carrying a review of existing standards and following stakeholder 
consultation. This exercise is completed in consulta tion with various leading manufacturers to ensure 
to reflect new testing methods. Quality Control Orders on sheet glass and safety glass envisage 
conformity assessment Scheme -1 of BIS (Conformity Assessment) Regulations 2018. As per QCOs, 
the product speci fied therein shall conform to the corresponding Indian Standard and shall bear the 
standard mark under the licence from BIS as per Scheme -1 mentioned above. This QCO is equally 
applicable to domestic and foreign manufacturers who intend to export their pro ducts in India. Under 
the provisions of Scheme -1 of BIS (Conformity Assessment) Regulation 2018, BIS grants a licence 
to the manufacturer based on the successful assessment of the manufacturing infrastructure, 
production process, quality control, and testi ng capabilities of a manufacturer through a visit to its 
manufacturing premises. Conformity of the product to the relevant standard is also established 
through third -party Laboratory testing located in India or testing in the manufacturing premises or 
 
6 For previous statements follow the thread under ID 669. G/TBT/M/83  
 
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  both. There is no provision under Scheme -1 of BIS (Conformity Assessment) Regulation 2018 to 
accept quality control assessments conducted by foreign firms and Labs.  
2.48.   Foreign inspection visits are on hold due to international travel restrictions. Once the COVID -
19 situation improves and the restriction is lifted, India will plan the inspections (factory visit). This 
standard (Part 1) prescribes the requirements, method of sampling, and test for safety glass meant 
for general purposes, such as for use in architect ural purposes, furniture, display boards, railway 
coaches, earthmovers, lighting fixtures, parts and components of appliances, equipment and 
machines, etc. As from the scope above and from the footnote given in the scope of the standard 
that "Thermal shock  test may be additionally carried out in the case of appliances", it is evident that 
"Appliances" are presently covered under the scope of IS 2553 (Part 1).  
2.1.2.6   United States - Energy Conservation Program: Energy conservation standards for 
residential dishwash ers, G/TBT/N/U SA/945/Add.3 , G/TBT/N/USA/1505/Add.2  
(ID 6707) 
2.49.   The representative  of China  provided the following statement. We suggest that the US (i) 
further improve product classification and provide corresponding testing procedures for sink 
dishwashers; (ii) clarify the differen ces and classification basis between dishwashers with a washing 
process of less than one hour and those currently containing a quick cleaning function of less than 
one hour, and (iii) clarify energy consumption and water consumption limits of the dishwashe rs with 
a washing cycle of less than one hour.  
2.50.   In response, the representative of the United States  provided the following statement. The 
United States thanks China for its comments submitted through the WTO TBT Enquiry Point on 7 
December 2020 on G/TBT/N/USA/945/Add.3  announcing the request for information on whether the 
US Department of Energy should amend energy conservation standards for dishwashers. In response 
to a petition for rulemaking received from the Competitive Enterprise Institute, the Department of 
Energy (DOE) published a final rule in 2020 that created a new product class for dishwashers 
whereby the "normal cycle" for such dishwashers would be 60 minutes or less. Manufacturers and 
consumer groups commented that the "quick or short cycle" that is present o n over 80% of 
dishwashers offered for sale already meet the 60 minute or less threshold and are presently 
unregulated by DOE, and therefore can use as much energy and water as designed by the 
manufacturer. When publishing the final rule for the new product  class, DOE did not specify 
standards or certification requirements for any products that could fall into this new product category 
- meaning that there are no new requirements or burdens placed on manufacturers who may choose 
to bring to market dishwasher s that meet the new threshold. Furthermore, subject to Executive 
Order 13992, DOE plans to review the final rule establishing the short cycle dishwasher product 
class. On 8 February 2021, DOE published in the Federal Register a petition for waiver and gran ted 
an interim test procedure waiver to Ningbo FOTILE Kitchen Ware Co. Ltd., establishing a new test 
method for very small "in-sink" dishwashers. On 9 December 2020, DOE published in the Federal 
Register decision and order granting a test procedure waiver to CNA International, establishing a 
new test method for very small, manual fill dishwashers.  
2.1.2.7   India - Refrigerating Appliances (Quality Control) Order, 2020 , 
G/TBT/N/IND/173  (ID 6718) 
2.51.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of India to protect customers and Korean companies are fully committed to complying 
with the regulations of India. However Korea would like to make some comments regarding this 
regulation (Refri gerating Appliances (Quality Control) Order, 2020 of India) as follows. On 
28 January 2021, through Indian WTO TBT Enquiry Point, Korea requested that the High Voltage 
Test Time specified in Clause 14.8 of the Indian standard  IS 1476(Part1):2000 and Clause  19.8 of 
IS 15750:2006 be revised to be one second , in line with the international standard (IEC 60335 -1). 
Korea is grateful for the written response of India on 2 February 2021, that it will review the revision 
of the High Voltage Test Time to one second in order to be harmonized with the international 
standard. The Korean once again requests that the standard be revised to harmonize with the 
international standard. In addition to the response of India, Korea also requests that the 
 
7 For previous statements follow the thread under ID 670. 
8 For previous statements follow the thread under ID 671. G/TBT/M/83  
 
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  Refrigerating Appliances  (Quality Control) Order, 2020 of India be implemented after the relevant 
Indian standard revision is completed and an appropriate transition period is provided.  
2.52.   In response, the representative of India provided the following statement. The standards have 
been made mandatory after carrying review of existing standard and following stake holder 
consultation. This exercise is completed in consultation with various leading manufacturers to ensure 
to reflect new testing methods. This measure does not hinder the  ability of foreign manufacturer to 
penetrate and reach into Indian market.  
2.1.2.8   Thailand - Ministerial Regulation Prescribing Description, Production, and Method 
of Displaying of Standard Marks on the Industrial Products, G/TBT/N/THA/577  (ID 6729) 
2.53.   The representative of the United Stat es provided the following statement. The United States 
appreciates Thailand's notification of its Ministerial Regulation prescribing the description, production 
and method of displaying of Standard Marks on its Industrial Products. The United States indust ry 
has submitted several comments through the US and Thai Enquiry Points beginning in October 2020, 
through January 2021. We appreciate the exchange through that mechanism and the recent 
extension of the effective date for implementation of the QR Code req uirement to 20 July 2021. 
However, the United States does have continued concerns regarding QR requirements. We 
encourage Thailand to consider other approaches that may meet consumer protection goals in a less 
trade -restrictive manner. In particular, a vol untary e -labelling approach in line with international 
best practices and standards could be considered. An e -labelling programme can help consumers 
discover important information without unnecessarily raising compliance costs and slowing time to 
market.  
2.54.   If a QR code requirement is to be maintained, efforts should be made to ensure that the 
specifics of the requirements are reasonable for the products within scope. For example, US industry 
representatives are concerned with the physical size and location r equirements of Thailand's 
proposed approach, as the physical marking requirements are large in comparison to marks and 
labels used in other global markets. We request the QR code be eliminated for batteries, as the 
packaging is too small to accommodate the  code. Regarding small audio -visual equipment, we 
request TISI to reduce the size restrictions for TISI logo and QR code on small AV products. We 
request TISI remove the requirement for the importer name to be imprinted on the power cord and 
ask that the r equirement for labelling of the importer name be moved to the label. We are seeking 
confirmation that a paperwork factory inspection is allowed in lieu of onsite factory inspections. If a 
paperwork inspection is acceptable, could you kindly provide TISI's guidelines on the process and 
what is required in the submission? We have heard that the price of a factory paperwork inspection 
is almost three times higher than the usual onsite factory inspection price. Can TISI please provide 
more explanation about thi s cost structure and explain the difference in scope and objectives 
between these two inspection processes? The United States requests Thailand to continue to 
examine the regulation and consider less trade -restrictive conformity assessment and labelling 
requirements to meet the legitimate objective of consumer protection.  
2.55.   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 echo the comments made by the United States. We share the same concern on 
the requirement for the size of Standard Mark, which includes TISI logo, QR code and TIS number. 
We seek clarification from Thailand on the method of displaying the S tandard Mark if the body of 
the commodity is too small or to accommodate such Mark. 
2.56.   In response, the representative of Thailand  provided the following statement. Thailand would 
like to thank the United States for valuable comments with regard to  the Ministerial Regulation 
Prescribing Description, Production and Method of Displaying of Standard Marks on the Industrial 
Products B.E.2563 (2020). We reiterate that the regulation is promulgated to fulfil legitimate 
objective under the scope of the TBT  Agreement, Article 2.2, whose purpose is to prevent deceptive 
practices and consumer protection. Therefore a licensee shall display the standard mark and the 
information of industrial products in electronic format (QR Code) to comply with the Ministerial 
Regulation. Due to the United States' concerns about the preparation of the manufacturers in 
displaying QR Code, we therefore extended the date of enforcement to 20 July 2021. And our 
responses to those concerns from the United States have been forwarded t o its respective TBT 
 
9 For previous statements follow the thread under ID 672. G/TBT/M/83  
 
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  Enquiry Point. We reaffirm that the notified Ministerial Regulation is issued in accordance with TBT 
Agreement and all those concerns from the United States have been taken into our consideration.  
2.1.2.9   Oman - Water heaters -energy performanc e requirements; Electrical Clothes 
Washing Machines Energy and Water performance requirements and Refrigerators, 
Refrigerator -Freezers and Freezers -Energy Performance, Testing and Labeling 
Requirements, G/TBT/N/OMN/412  (ID 67310) 
2.57.   The representative of the Republic of Korea  provided  the following statement. Korea respects 
the efforts of Oman to protect the environment and Korean companies are fully committed to 
complying with the regulations of Oman. Korea submitted the comments on Omani standards for 
"Electrical Clothes Washing Mach ines Energy and Water performance requirements" and 
"Refrigerators, Refrigerator - Freezers and Freezers -Energy Performance, Testing and Labelling 
Requirements " notified to the WTO on 27 July 2020 as G/TBT/N/OMN/412 . The comments were 
submitted to the Oman TBT Enquiry Point in Nov ember 2020, and the main contents are as follows. 
Firstly, regarding Clause 3.4 of electrical clothes washing machine energy efficiency standard, Korea 
has requested clarification of the water temperature requirements and allowance of the test at the 
suppl y water temperature specified by the manufacturer. Since the relevant international standards 
(IEC 60456, etc.) also allow the supply water temperature specified by the manufacturer, Korea has 
requested that Oman modify Clause 3.4 to be harmonized with the  international standard. 
Additionally, regarding Clause 4.5, Korea has requested clarification of some misused or ambiguous 
market surveillance terms and additional information on input power testing method. Secondly, as 
for the refrigerators, clarificatio n of some misused or ambiguous market surveillance terms has been 
requested.  
2.58.   Also in the standard annual energy consumption (SAE) formula applied in Oman, confirmation 
of the part that differs from the calculation formula applied in the international stand ards and 
neighbouring countries has been requested. In addition, detailed information on temperature and 
humidity conditions regarding the anti -condensation heater power consumption has been requested. 
Thirdly, as common issues for both electrical clothes washing machine and refrigerator, modification 
of typo in energy labelling (water extraction efficiency class unit, annual water consumption and 
water efficiency class unit, etc), confirmation of energy labelling size, and possibility of modifying 
air cond itioner energy efficiency labelling which in already in effect have been requested. Lastly, 
confirmation as to whether the multi -drum washing machine is subject to the energy efficiency 
regulations of Oman has been requested. For the details of the above f our requests, please refer to 
documents submitted to Oman TBT Enquiry Point in February this year and please review requests 
of Korea again.  
2.59.   The representative  of Oman  did not provide a response to the concerns raised. These concerns 
were subsequently transmitted  to the relevant authorities.  
2.1.2.10   India - Caustic Soda Quality Control Order, 2017, G/TBT/N/IND/69  (ID 67411) 
2.60.   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 express its concerns about the Order issued by India's Ministry of Chemicals and 
Fertilizers on Caustic Soda on 3 April 2018. The draft measure was notified by India to the TBT 
Committee as G/TBT/N/IND/69  on 7 December 2017. Although this measure is n ot one of India's 
notified measures subject to STC 630 , we are of the view that it is also part of the policy to require 
compliance of chemicals with BIS standards. Our industry has been encountering difficulties in 
obtaining certification even though all procedures had been completed prior to the outbreak of 
COVID -19, and no information seems to be available up to this date from the authority on the current 
stage of the application and the subsequent processes to go through before approval is granted. The 
lengthy and non -transparent conformity assessment procedures are creating unnecessary burdens 
as well as uncertainties for manufacturers located outside India. We urge Indian authorities to 
observe the obligations stated in Articles 5.2.2 of the TBT Agreem ent by establishing a reasonable 
standard processing period of each conformity assessment phases and communicating the results 
of assessment promptly in a precise and complete manner to the applicants. In particular, we would 
 
10 For previous statements follow the thread under ID 673. 
11 For previous statements follow the thread under ID 674. G/TBT/M/83  
 
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  like to request India provide a contact point for foreign manufacturers to enquire and follow up their 
application cases. We thank India for taking into account our comments.  
2.61.   In response, the representative of India provided the following statement. The STC is noted 
and is presently be ing examined.  
2.1.2.11   European Union - Non-recognition of test certificates (by Italy and the 
Netherlands) issued to electrical equipment by Central Power Research Institute (CPRI) 
(ID 67512) 
2.62.   The representative of India provided the following statement. The Republ ic of India is deeply 
concerned with the EU's refusal to recognize the test certificates issued by the CPRI (Central Power 
Research Institute) for electrical equipment. This non -recognition adversely affects the Indian 
exports to the EU. Italy and the Neth erlands reject the design and acceptance certificates issued by 
CPRI to Indian manufacturers for electrical equipment such as power/distribution transformers, 
cables, conductors, disc insulators, circuit breakers, energy meters, capacitors, etc. Exporters are 
being asked to obtain international certificates from ASTA/UK, KEMA/Netherlands, CESI/Italy. The 
Central Power Research Institute (CPRI) is the Indian National Institute for research and 
development in electrical power engineering. It is an Intertek Re cognized Testing Laboratory (Level 
4) for certain electrical products. Consequently, CPRI is empowered to issue ASTA Certificates 
provided that testing occurs in the presence of an ASTA Observer. CPRI has facilities in Bhopal and 
Bengaluru, both of which a re accredited by ASTA.  
2.63.   The non -acceptance of CPRI certificates by Italy and the Netherlands adds an extra testing 
cost for exporters, which can be avoided. Additionally, these unnecessary procedures make Indian 
exporters ineligible to participate in tender s in these countries. Therefore, Italy and the Netherlands' 
non-recognition of test certificates issued by CPRI is trade -restrictive. It is violative of Article 2.2 of 
the WTO -TBT Agreement, which specifies members must not prepare, adopt or implement any 
provisions that would create unnecessary international trade barriers. Hence, we request the EU 
share the reasons for the non -acceptance of CPRI certificates for electrical equipment. India would 
appreciate it if the EU could respond to this concern in wri ting. 
2.64.   In response, the representative of the European Union  provided the following statement. 
Thank you to the delegation of India for its comments on the refusal to recognize the test certificates 
issued by the Central Power Research Institute for the ele ctrical equipment. We have not yet received 
any information regarding the rejection of the design and acceptance of certificates by member 
States. The EU would like to ask the Indian delegation to indicate bilaterally which organisations are 
rejecting the certificates. The EU is liaising with the competent national authorities and will get back 
to India in due time with a more detailed reply based on additional information received.  
2.1.2.12   Canada - Medical Device Single Audit Program (MDSAP) (ID 67613) 
2.65.   The represe ntative of China  provided the following statement. According to the "Principle of 
minimum trade restriction " and the acceptance level of MDSAP in other members concerned, it is 
recommended to use either MDSAP or former Canadian Medical Devices Conformity A ssessment 
System (CMDCAS) to obtain a quality system certificate. The reasons are as follows. Firstly, the 
MDSAP certifications system in five related M embers  is still in the trial operation, MDSAP certification 
has a very limited acceptance level on a glo bal scale at this stage. By now, only in Canada is MDSAP 
certifications mandatory. The other 4 Members, United States, Japan, Australia, and Brazil only use 
it as an optional method to get a quality system certificate. Secondly, the implementation of the 
MDSAP is intended to allow for a single audit to satisfy the regulatory requirements and to ease the 
burden of repeated certifications in different Members. However, the earlier implementation of 
mandatory MDSAP certification requirements has become an unne cessary burden for medical device 
manufacturers and organizations, especially small and medium -sized ones.  Thirdly, before 1 January 
2019, the auditing model CMDCAS is adopted to fulfil the requirements of Article 32 (Application for 
a Medical Device Licen ce) of Medical Devices Regulations (SOR/98 -282). No single case indicates 
that this auditing model cannot fulfil the regulation goals.  
 
12 For previous statements follow the thread under ID 675. 
13 For previous statements follow the thread under ID 676. G/TBT/M/83  
 
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  2.66.   In response, the representative of Canada  provided the following statement. The transition 
from the Canadian Medical Devices Conformity Assessment System to the Medical  Device Single 
Audit Program (MDSAP) was announced in December  2015 and took effect on 1  January  2019, 
giving the industry over three years to make the transition.  The MDSAP represents a significan t 
milestone in international regulatory cooperation and work -sharing. The MDSAP has enabled us to 
transition from a solely Canadian programme to one aligned with other major international markets 
through the use of the same ISO standard. By accepting the r esults of these audits, the participating 
countries (Canada, Australia, Brazil, Japan and the United  States) have demonstrated their 
commitment to reducing the number of inspections and audits faced by medical device 
manufacturers.  The MDSAP enhances the m onitoring of the quality of medical device manufacturing 
by applying a coherent, targeted and risk -based approach to audits, which was absent from the 
previous approach. The MDSAP also provides for the standardization of reports on audit results, 
allowing for the use of reporting tools to identify and explore industry compliance trends, in addition 
to a coherent grading system for audit results.  The programme also includes an early warning system 
for regulators when serious negative results are found during  audits, which enables regulators such 
as Health Canada to promptly investigate and take measures to mitigate emerging risks.  The 
Canadian Medical Devices Conformity Assessment System no longer exists as it has been replaced 
by the MDSAP. Canada does not i ntend to revert to this programme and ISO  standard  13485 alone 
does not sufficiently satisfy our requirements.  
2.1.2.13   China - Inventory of Existing Chemical Substances Produced or Imported in 
China (IECSC) requiring mandatory registration of certain chemicals for  import and not 
notified at WTO (ID 67714) 
2.67.   The representative of India provided the following statement. The Chinese Ministry of Ecology 
and Environment (MEE) (erstwhile Ministry of Environment Protection or MEP) issued its Order 12 
(MEE 12). This order came into force on 1 January 2021 and replaced the earlier order MEP Ord er 7. 
The MEE Order 12 was first notified to the WTO on 2 September 2019 and was followed up with an 
implementation guideline that was also notified to the WTO on 4 September 2020. China maintains 
a list of "Inventory of Existing Chemical Substances Produc ed or Imported in China (IECSC)". India 
is concerned about the limited number of items included in this list. This list does not contain many 
chemicals that China regularly imports. The chemicals not listed under IECSC require registration. 
New substances become eligible for IECSC five years after first approval (as per MEE 12). However, 
in practice, the process of adding new chemicals to the IECSC even after the completion of five years 
is prolonged. The regulatory and administrative system for chemicals i n China thus adds unnecessary 
delays and costs to the exporters.  
2.68.   Concerns : When adding new substances meeting PB, PT, or BT  criteria to IECSC, the MEE will 
also specify allowed uses in IECSC. Should these substances be put to other uses, they will be 
subje cted to new use management rules and require notification. Despite being on the list already, 
a substance has to undergo the same procedure as a new substance only because it is put to a 
different use. This is burdensome. Once the substance has completed t he due procedure for being 
included in the IECSC list, the new use addition procedure may be simplified. This issue becomes all 
the more important because adding more chemicals to the list of IECSC is already prolonged. This 
is also evident from the fact t hat during the last ten years, only 573 new chemicals are added to the 
list of IECSC. The IECSC was officially provided in 2013 by the Ministry of Ecology and Environment. 
It contained 45,612 chemicals. This was then subsequently updated with additions in 2016 (31 
substances), 2018 (45 substances), January 2019 (28 substances), January 2020 (47 substances), 
May 2020 (156 substances), October 2020 (28 substances), and December 2020 (238 substances). 
In view of this, China is requested to consider simplifying  the process for adding new uses of existing 
substances in the list of IECSC.  
2.69.   Under MEE 12, notified new substance would be added to IECSC five years from its approval 
date. However, the process does not appear to be an automated one. Once a new substance is 
eligible to be included in the IECSC, the Chinese regulatory body, in consultation with appropriate 
technical committees, considers whether such substance should be included in the IECSC. Further, 
there is no clarification on how much time it may take f or a product to be included in the list of 
IECSC. In view of this, China is requested to make the process of adding new substances to the list 
of IECSC systematic, time -bound, and transparent. Thirdly, there is no clarity about whether the 
new substances t hat have completed five years as per MEP 7 will be automatically included in the 
 
14 For previous statements  follow the thread under ID 677. G/TBT/M/83  
 
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  IECSC under MEE 12. If not, what further procedural obligations (and why) are expected before 
these substances are included in the list. Article 2.2 of the TBT Agreement lays down certain 
objectives deemed "legitimate" for regulatory purposes. The TBT Agreement acknowledges 
Members' right to fulfil these objectives by regulating through technical regulations; however, the 
Agreement also emphasizes that such regulations shall no t be implemented with a protectionist 
intention. Technical regulations are not to be formulated and implemented to make them more 
trade -restrictive than necessary to achieve a policy goal. In the case of this Chinese measure, new 
substances become eligible  for addition onto IECSC five years from the date of the first 
commencement of manufacturing or importation (as per MEP 7). However, in practice, China is very 
slow in adding new chemicals to the IECSC even after the completion of five years. The regulator y 
and administrative system for chemicals in China adds unnecessary delays and costs to the exporter. 
Further, there is also no clarity on these aspects under MEE 12. In view of the above, China is 
requested to make the process of adding new substances to the list of IECSC systematic, time -
bound, and transparent.  
2.70.   In response, the representative of China  provided the following statement. According to the 
Measures on the Environmental Management Registration of New Chemical Substances (Order No. 
12 of the Min istry of Ecology and Environment), China  implements an environmental management 
registration system for new chemical substances. The new substances refer to substances  that are 
not included in the "Inventory of Existing Chemical Substances in China" , which  was formulated, 
adjusted and published by the competent authority  of ecology and environment . It include s chemical 
substances that had been produced, sold, processed, used or imported in China before 15 October 
2003, as well as those listed in accordance with relevant regulations on environmental management 
of new chemical substances afterwards.  In line with the TBT Agreement, China made a TBT 
notification on the Measures on the Environmental Management Registration of New Chemical 
Substance s in September 2019, and notified the  Guidance for Environmental Management 
Registration of New Chemical Substances in September 2020.  
2.1.2.14   Mexico - Conformity Assessment Procedure under Mexican Official Standard 
NOM -223-SCFI/SAGARPA - 2018, "Cheese Names, Specifications, Com mercial 
Information, and Test Methods," published on 31 January 2019, G/TBT/N/MEX/465  
(ID 67815) 
2.71.   The representative of the United States  provided the following statement. On 5 May 2020, 
Mexico notified the WTO of its draft conformity assessment procedures for cheese included in its 
Official Mexican Standard (NOM) -223, including name, specifications, co mmercial information and 
test methods in G/TBT/N/MEX/465 . In response, the United States and its industry submitted timely 
comments to Mexico on 3 July 2020. In addition, the United States and its industry participated in 
the NOM -223 working group that was convened by the Ministry of Economy and the Ministry of 
Agriculture and Rural Development between 14 August and 11 September 2020, including providing 
expert presentations on standards of identity for cheese by the Agricultural Marketing Service and 
the Food and Drug Administratio n, and the Department of Agriculture was a regular participant.  The 
opportunity to provide comments to the Mexican regulatory process and participate in the working 
group are greatly valued and we take sincere interest in participating. The United States a nd its 
stakeholders also participated in the early drafting of the NOM and provided comments to Mexico's 
National Commission for Regulatory Improvement (CONAMER) in 2018. In its notification, Mexico 
listed the objective of the conformity assessment procedu res to be prevention of deceptive practices 
and consumer protection. Our understanding is that the conformity assessment procedures are 
required to determine the quality and truthful marketing of products called "cheese, " and not for 
food safety. Mexico is  proposing to establish consumer confidence in the marketing of cheese 
products through a certification scheme and self -documented declaration of conformity. The question 
is whether Mexico found any evidence of relevant scientific and technical information  and incidence 
of non -compliant products to justify this onerous certification scheme for the objective of preserving 
quality of cheese in the market?  
2.72.   In July 2020, the United States commented on the draft NOM -223 and questioned the need 
for: (i)  mandatory  conformity assessment procedures that were originally listed as voluntary in the 
initial 2018 draft; (ii) mandatory testing procedures, particularly with newly improved NOM -51 
labelling requirements to label cheese made from vegetable fat as "imitation ", and existing 
requirements for certificates of analysis, which include information on cheese formulation, including 
 
15 For previous statements follow the thread under ID 678. G/TBT/M/83  
 
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  fat and moisture content; and (iii) the need for the fatty acid testing, as it is not recommended by 
Codex  and it is unclear how it will impr ove the quality of cheese or inform consumers. We also made 
less trade -restrictive suggestions to improve Mexico's labelling practices for cheeses derived from 
vegetable versus animal fats, and noted that the CONAMER analysis of the measure considered that  
mandatory testing procedures could increase the price of cheese in the Mexican market, which would 
further force consumer substitutions for lower -quality products. Our industry also recommended 
conformity assessment alternatives that would achieve the obj ective pursued by NOM -223, in a less 
trade -restrictive manner, including the: (i) recognition of documentation already delivered or 
available to the authorities; (ii) application of market surveillance by the competent authorities; 
(iii) preparation and is suance of a specific NOM for products made with vegetable fat, which would 
provide separate requirements for cheese considered "imitation "; (iv) application of the voluntary 
scheme in the original draft CAP -NOM-223; or (v) requirement for a declaration of conformity by the 
producer. All of these alternative measures are less strict as they do not require the submission of 
performance reporting or additional testing to which the industry is already exposed; they contribute 
to the objective of avoiding mislea ding labelling of imitation products; and are reasonably available 
to competent authorities.  
2.73.   We recommended and requested Mexico continue the use of international standards and test 
methods, and consider suppliers' declaration of conformity as a means to a ttest that any required 
testing procedures had been performed. When we met bilaterally with Mexico in October 2020, we 
asked that Mexico recognize and accept testing from conformity assessment bodies located outside 
of Mexico, to ensure testing could be pe rformed at the point of production. Despite participating in 
early 2018 drafting, providing comments to CONAMER in 2018, providing comments in response to 
WTO TBT notification in July 2020, expert participation in the working group in August through 
Septem ber 2020, the United States remains extremely concerned that the final draft shared with 
working group members by Mexico on 26 January with a slightly modified text on 11 February have 
not reflected our consistent comments, or those of our stakeholders, in  the Mexican regulatory 
process.  
2.74.   We note that this is the first time we have raised these conformity assessment procedures in 
the WTO TBT Committee at this late stage. It is not because we just became aware of this measure. 
It is because we have been dilig ently participating in the Mexican regulatory process for over two 
years, at every stage. We have had past success working within the Mexican system and believed 
our comments, and the comments of other WTO Members and interested parties, would be taken 
into consideration in the final measure. Unfortunately, it is now our understanding that they have 
not been taken into account, which is especially unfortunate in this circumstance and at this late 
stage. Our understanding is that Mexico is considering the co nformity assessment procedures to 
include an annual cheese certification. In 2021, cheese will be required to have a third -party 
certification per batch and family of products, and in the alternate year, for example in 2022, cheese 
will be required to have  a suppliers' declaration of conformity per batch and family of products. We 
note, certifying and auto -declaring per batch and family of products means continuous certification 
and auto -declaration, as production lines at some facilities can start a new ba tch every 24 hours. 
The third -party certification scheme will also require an initial plant inspection of the cheese 
production facility. Product surveillance and traceability will also be the responsibility of the 
certification body. The type of certifica tion scheme and facility inspection for every batch and family 
of products contemplated in these final conformity assessment procedures is the kind of scheme 
created and intended for situations where the objective is safety. An example of the type of produ ct 
that usually carries this type of certification scheme is a product that could electrocute or explode. 
The type of scheme contemplated by Mexico in this instance does not appear to be proportionate to 
the risks that non -conformity would create and may b e considered more trade restrictive than 
necessary to fulfil the legitimate objective of the regulation.  
2.75.   We request that Mexico halt the issuance of the final cheese conformity assessment 
procedures, re -consider the risks that non -conformity would create b efore issuing the final 
conformity assessment procedure, and go back to drafting the conformity assessment procedure 
with trading partners and stakeholders. What risk would non -conformity create? Is that risk of fraud 
or consumer information proportionate to requiring every cheese production facility exporting to 
Mexico to be inspected, every batch of every product family required to undergo expansive and 
expensive battery of testing, and also employ a certification body for post -market surveillance and 
traceability? Has labelling been fully explored to meet consumer needs for information to meet some 
of the objectives this certification scheme would attempt to achieve? Further, this would be an 
entirely new certification scheme that has never existed in any  other country previously for cheese. G/TBT/M/83  
 
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  If this certification scheme contemplated is included in the final regulation, it would be extremely 
onerous, if not impossible, to put into force within 60 days or even by the end of 2021. We have 
surveyed the capabil ities and accreditations for the appropriate scope of testing in the United States. 
While the United States has capabilities, none of the laboratories or certification bodies would be 
immediately familiar with this new certification scheme and it would tak e time for producers to 
employ testing and certification bodies and to inspect the production facilities. Given the limited 
number of accredited laboratories and certification bodies available to do the work, there would likely 
be a delay or suspension of exports of cheese to Mexico.  
2.76.   Additionally, any product sold to Mexico would suffer increased prices to offset the cost of 
these conformity assessment procedures. Those additional costs, for testing, services of a 
certification body for facility inspection,  certification, surveillance, and traceability, would put some 
US producers of cheese entirely out of the market. Since these requirements will also apply to 
domestic products, cheese may become unaffordable and consumers may resort to purchasing less 
expensive substitutes, as CONAMER has predicted, perhaps leading to an increase of adulterated 
cheese on the market. The United States exported US$428 million in cheese to Mexico in 2020. We 
again request Mexico suspend the final measure, keep drafting with tr ading partners and 
stakeholders, and consider the low -risk nature of cheese and allow for suppliers' declaration of  
conformity to attest compliance to the testing procedures required in NOM -223. 
2.77.   The representative of the European Union  provided the followi ng statement. The European 
Union would like to join this trade concern, as some aspects of the conformity assessment procedure 
established by the Procedure for the Evaluation of Conformity of the Official Mexican Standard NOM -
223, in particular high freque ncy of product testing and production facilities inspections, would cause 
difficulties for EU exporters. We would appreciate a possibility to work bilaterally with Mexico to 
receive some clarifications and find a satisfactory solution.  
2.78.   The representative o f Australia  provided the following statement. Australia would like to note 
its concerns that Mexico 's measure notified as  G/TBT/N/MEX/465  appears discriminatory and more 
trade restrictive than necessary. We provided comments Mexico 's notification detailing our specific 
concerns wit h the measure. Australia welcomes Mexico 's consideration of, and response to, these 
comments and looks forward to continuing our successful trade relationship.  
2.79.   In response, the representative of Mexico  provided the following statement. The delegation 
of Me xico welcomes the comments made by the delegation of the United States of America on the 
conformity assessment procedure for the technical regulation on cheese, which seeks to address the 
problems identified in the verification processes for this product at the points of sale to the final 
consumer. Several irregularities have been detected in these processes regarding products that do 
not provide truthful information to consumers.  The objectives pursued through this measure include 
the prevention o f misleading practices, on the basis of cases of non -compliance detected in products 
of both domestic and foreign manufacture. It is vital to demonstrate the compliance of any product 
bearing the name "cheese" with the relevant technical regulation, which,  in this case , is Mexican 
Official Standard NOM -223. Regarding the specific questions raised by the United States of America, 
the following comments have been made:  (1) NOM -223-SCFI/SAGARPA -2018 does not establish 
that conformity assessment is voluntary. The second transitional article provides that the authorities 
shall initiate work on the development of the conformity assessment procedure within 60 calendar 
days following the publication of the Mexican Official Standard in the Official Journal.  
2.80.   (2) The changes in commercial information set out in Mexican Official Standard NOM -051-
SCFI/SSA1 -2010 will enter into force on 1 April 2021, and it has now been verified that the product 
labels do not provide consumers with accurate information . It is therefore necessary that all products 
known  as "cheese" be certified, due to the constant and increasing level of non -compliance that has 
been officially documented by the Federal Consumer Protection Agency  (PROFECO), to the detriment 
of Mexican consumers and healthy competition between producers.  (3) Fatty acid profile test s 
demonstrate that the product has not been altered or adulterated in its butterfat (milk  fat) 
composition with vegetable fat to reduce costs. Mexico has officially documented that the product 
known  as "cheese" is adulterated with vegetable fat and, in many cases, the consumer is not 
informed. It has therefore been determined that this test is necessary to demonstrate the 
authenticity of the cheese marketed in the national territory. The technical ev idence is contained in 
the various quality studies carried out by PROFECO, which is the consumer defence authority in 
Mexico. We are able to share this evidence with any interested part ies. G/TBT/M/83  
 
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  2.81.   With regard to the use of test methods  and international standards , test methods from 
international standards have been included for each of the physico -chemical specifications 
established in the Mexican Official Standard and its normative references.  In addition to the above, 
the foreign standards requested by the Unite d States of America , which have proven to be equivalent 
to international standards , have been included, thus demonstrating  the Mexican authorities' 
commitment to ensuring effective compliance for foreign countries.  Moreover, the procedure 
provides for the recognition of conformity assessment bodies located abroad and does not require 
the presence of offices in Mexico. Similarly, regarding the points made by the United States of 
America, there are two different certification schemes as set out in section  4.2.1: I. Periodic 
inspection of the product and audit of the product manufacturing process. This scheme provides for 
the initial inspection of the product, with  an assessment  carried out at the industrial plant of the 
control that the manufacturer has over t he manufacturing process, followed by an inspection during 
the certification year of the certified product.  II. By batch. This scheme provides for the inspection 
of a particular batch of products.  A product batch certificate is not required. It is for dome stic or 
foreign producers to choose the most appropriate scheme for their production.  
2.82.   It also states that the certification body must determine the size of the sample and carry out 
periodic inspections  all the way  from the plant to the point of final deliv ery to the importer (in the 
case of foreign importers ) and at point of sale to the final consumer ( in the case of domestic 
importers ), in order to verify that the product continues to comply  with the same conditions under 
which a certificate was issued. Th is is complemented by the verification and monitoring activities 
undertaken by the authorities of the Mexican Government in the national territory.  The entry into 
force of this procedure will be amended to address the comments and concerns expressed by the 
domestic and foreign industries, given the importance of ensuring sufficient infrastructure for 
conformity assessment bodies both in the national territory and abroad to guarantee effective 
implementation.  Concerning the costs of conformit y assessment, based on the evidence presented 
during the development of the conformity assessment procedures , it was determined that product 
certification does not represent a significant economic cost or have a high impact on producers or 
the final consum er. However, we invite the delegation of the United States of America to present its 
technical evidence on the high economic cost of this procedure.  
2.1.2.15   Nigeria - Onerous testing and conformity requirements by société générale de 
surveillance, (SGS) for machin ery and their parts (ID 67916) 
2.83.   The representative of India provided the following statement. The Republic of India is deeply 
concerned about Nigeria's onerous certification and conformity requirements, which adversely affect 
Indian exports to Nigeria. Unde r the current regime in Nigeria, all importers must obtain a Product 
Certificate (PC) and a SONCAP Certificate (SONCAP is a pre -shipment verification of conformity to 
Nigerian standards) for each consignment. The process of obtaining PC and meeting the con formity 
assessment requirement is onerous, intensive, and expensive. It involves an elaborate two -step 
process which is explained below.  
2.84.   The first step is obtaining a PC. To place an order for the import to Nigeria, the importer needs 
a Bank in Nigeria to  issue Form M. This Form M can only be issued based on the PC. The PC is issued  
based on the test report. The test report can be issued only once the actual production has started. 
The actual production will begin only after receiving Form M which is an in tent for payment. From 
this, it is clear that obtaining a PC is a circulatory and highly trade -restrictive process. Secondly, the 
validity of a PC issued by Nigerian authorities is only six months, which is a very short time. This 
adds an extra burden on t he exporter both in terms of cost and time required for obtaining another 
PC. We consider that these measures are highly trade -restrictive and create unnecessary obstacles 
to trade. Hence, Nigeria is requested to consider simplifying the procedure for obta ining the PC and 
sharing the risk assessment done to arrive at the PC's six -months validity.  
2.85.   The second step is obtaining a SONCAP Certificate. Once the order for a product is placed and 
the PC requirement is met (as mentioned in the first step), before t he product can be exported to 
Nigeria, a SONCAP Certificate for each consignment is required. This requirement of obtaining a 
SONCAP certificate is in addition to the PC requirement. This process of conformity assessment for 
each shipment is cost -intensive  and involves onerous procedures.  
 
16 For previous statements follow the thread under ID 679. G/TBT/M/83  
 
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  2.86.   Countries establish such onerous conformity assessment requirements for products that have 
implications for human health upon consumption, plant/animal health or environment, restricted or 
prohibited category of products, or products originating from restricted countries into their territory. 
In other words, the degree of risks upon importation must be determined for placing such stringent 
conformity assessment requirements. In Nigeria's case, except for a few products, eac h consignment 
is required to obtain a SONCAP certificate. We request Nigeria to share the risk assessment to 
mandate such intensive conformity assessment requirements. Further, the Nigerian requirement of 
SONCAP certificate for each consignment appears to violate Article 5.2 of the TBT Agreements, 
requiring that a WTO Member's conformity assessment procedures do not create unnecessary 
obstacles to international trade. Additionally, Article 2.2 of the TBT Agreement specifies that 
Members must not prepare, ad opt or implement any provisions that would create unnecessary 
international trade barriers. In view of the above, Nigeria is requested to share the risk assessment 
for the following: (a) requirement of a PC for all products; (b) six months validity of PC; (c) the 
requirement of obtaining a SONCAP certificate for each consignment; and (d) the less trade -
restrictive measures that were considered before finalizing the present mechanism.  
2.87.   In response, the representative of Nigeria  provided the following statemen t. We take note of 
India's comments and concerns raised. We have notified capital on this issue. We shall revert back 
to the meeting as soon as we get a response from Capital.  
2.1.2.16   European Union - Testing methods for prohibited chemicals of regulation on 
cosme tic products , G/TBT/N/EU/752  (ID 68017) 
2.88.   The representative of China  provided the following statement. We suggest that the EU clarify 
the testing method for volatile nitrosamines in nail polish products. As it was clearly indicated that 
the storage conditions and stability under in -use conditions can result in hydroquinone  formation , 
we suggest that the EU clarify the conditions and scientific principles for the conversion from 
deoxyarbutin to hydroquinone in cosmetics. As Chinese labs do not find the evidence of this 
conversion in practices , it is also suggested that the EU could provide the testing methods for the 
conversion in cosmetics.  
2.89.   In response, the representative of the European Union  provided the following statement. The 
EU would like to remind China that a written reply to their comments of 16 December 2020 was 
submitted via the TBT Enquiry Point on 4 February 2021. As stated in the reply, the EU observes 
that the draft is based on t he Opinion of the Scientific Committee on Consumer Safety (SCCS) on 
deoxyarbutin Tetrahydropyranyloxy Phenol (SCCS/1554/15). In this Opinion the SCCS concluded 
that: "hydroquinone will be formed at levels which raise concerns with regard to the safety of s uch 
products during life -cycle of the product (e.g. storage conditions and stability under in -use 
conditions) ". Considering that hydroquinone is among the substances prohibited for use in cosmetics 
products, listed under entry 1339 of Annex II to the Cosme tics Regulation – with solely the exception 
of entry 14 in Annex III – the conclusion of the SCCS clearly implies the need to regulate the use of 
deoxyarbutin in the Cosmetics Regulation. This is in accordance, notably, with Article 31(1) of the 
Cosmetics Regulation, according to which where there is a potential risk to human health, arising 
from the use of substances in cosmetic products, which needs to be addressed on a Community -
wide basis, the Commission may, after consulting  the SCCS, amend Annexes II to VI accordingly.  
2.90.   In that respect, the EU also observes that whilst the Opinion of the SCCS was adopted in 
2015, it is solely for administrative reasons that the Commission did not proceed immediately to 
adopt a measure prohibiting the use of deoxyarbutin  in cosmetics. The current draft legislative 
measure is, therefore, aimed at reflecting the SCCS Opinion mentioned above without further delays. 
In addition, the EU would like to recall that a large body of scientific evidence shows that 
hydroquinone is a known clastogenic and cytotoxic agent in vitro  and in vivo . This fact does not 
depend on the detection method. Hydroquinone has been classified under the "Classification, 
Labelling and Packaging" (CLP) Regulation (Regulation (EC) No 1272/2008) both as muta genic 
(Muta.2) and carcinogenic (Carc.2). It is the responsibility of the industry to use the appropriate 
validated method and quantify the conversion of deoxyarbutin to hydroquinone or invest in the 
relevant R&D in order to stabilize the deoxyarbutin and hinder its conversion to hydroquinone. The 
SCCS Opinion clearly indicated that the storage conditions and stability under in -use conditions can 
result in hydroquinone formation, which "raise concerns ". 
 
17 For previous statements follow the thread under ID 680. G/TBT/M/83  
 
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  2.1.2.17   India - Plain Copier Paper (Quality Order) 2020, G/TBT/N/IND/140  (ID 68118) 
2.91.   The representative of Indonesia  provided the following statement. Indonesia thanks India for 
notifying the draft of Plain Copier Paper Quality Control Order on 14 February 2020 to TBT WTO 
Members through notification G/TBT/N/IND/140 . However, Indonesia regrets that enquiries made 
to the responsible minister are receiving no response. Indonesia as one of the largest paper -
exporting countries in India is greatly affected by this regulation. India is one of the largest trading 
partners of Indonesia and is the sixth largest export destination country for paper produc ts. 
Unfortunately, in the current development, several policies that have been issued by India have 
impacted and become trade barriers for Indonesian paper exports such as the mandatory 
implementation on Indian Standards regulation. The value of Indonesian  exports in the period 
January -November 2019 was US$201.9 million, meanwhile the value of Indonesia's exports to India 
in the same period in 2020 was only US$74 million or decreased by 63%. The procedures required 
by India Trade Policy significantly create  obstacles for Indonesia's paper export to India. In 
accordance with the provisions of the conformity assessment, certification shall be carried out by 
Bureau of Indian Standard based on the Conformity Assessment Regulation 2018 through the 
Scheme 1 of Sch edule -II which shall require factory visit, sampling and testing of products as  well 
as licensing procedure.  
2.92.   Indonesia requests clarification from India on whether this certification scheme applies equally 
both to local and foreign manufactures, or only ap plies to foreign paper procedures. Indonesia views 
that the scheme used may cause foreign producers to experience difficulties  in implementing the 
scheme. Moreover, India's hesitation to replace factory visit requirement with remote assessment 
during COVID -19 pandemic has caused registration and testing procedures to take longer than it 
should be and can potentially disrupt flow of goods to India. Therefore, Indonesia urges India to 
consider the implementation of remote assessment or any relaxation policy d uring COVID -19 
pandemic. Indonesia also requests India to consider providing a longer transition time, for at least 
24 months, and allow adequate time for foreign producers to adjust their products. Indonesia also 
requests India to provide the information on the harmonization of testing methods used in the 
IS 14490:2018 to ISO standards. Lastly, we noticed that India, through the Ministry of Commerce 
and Industry, had published mandatory implementation of Plain Copier Paper (Quality Control) Order 
2020 Regu lation on 5 June 2020. This regulation will come into force after six months from the date 
of its publication, which is 5 December 2020. In this regard, we kindly remind India to notify this 
technical regulation to this Committee, as the addenda of the pre vious notification.  
2.93.   In response, the representative of India provided the following statement. Under the 
provisions of Scheme -1 of BIS (Conformity Assessment) Regulation 2018, BIS grants a licence to 
the manufacturer based on successful assessment of the m anufacturing infrastructure, production 
process, quality control and testing capabilities of a manufacturer through a visit to its manufacturing 
premises. Conformity of the product to the relevant standard is also established through third party 
laboratory  testing located in India or testing in the manufacturing premises or combination of both. 
There is no provision under Scheme 1 of BIS (Conformity Assessment) Regulation 2018, to accept 
quality control assessments conducted by foreign firms and labs. Prese ntly foreign inspection visits 
are on hold due to the prevalent restrictions on international travel in view of the ongoing COVID -
19 pandemic. As soon as the situation of COVID -19 improves and the restrictions are lifted, BIS will 
plan the inspections.  
Sl. 
No. Requirement  Indian Standard  Corresponding ISO 
Standard  
1 Moisture  IS 1060 Part 5/Sec 2:2014  ISO 287:2009  
2 Thickness  IS 1060 Part 5/Sec 3: 2014  ISO 534:2011  
3 One minute Cobb test (both sides)  IS 1060 Part 5/Sec 4:2014  ISO 535:1991  
4 Surface Strength, Dennison, (Wax pick)  8 of IS 1060 (part 3) (No corresponding ISO)  
5 Grammage  IS 1060 Part 5/Sec 5: 2014  ISO 536:2012  
6 Smoothness for both sides (Bendsten)  3 of IS 9894 (ISO 2494, now withdrawn)  Indigenous (ISO 
8791-2:2013)  
 
18 For previous statements follow the thread under ID 681. G/TBT/M/83  
 
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  Sl. 
No. Requirement  Indian Standard  Corresponding ISO 
Standard  
7 Ash content (at 900°C)  11 of IS 1060 (Part 1)  Indigenous (ISO 
2411:2019)  
8 Taber Stiffness  Appendix D of IS 4658  Indigenous (2493 -
2:2020)  
9 Tear Index  IS 1060 Part 6/Sec 1:2014  ISO 1974:2012  
10 Tensile Index  IS 1060 Part 5/Sec 6:2014  ISO 1924-2:2008  
11 ISO Brightness  IS /ISO 2470 (Part 1):2009  
12 Opacity  IS/ISO 2471: 2008  
 
2.1.2.18   Morocco - Automotive glass testing requirements (ID 68219) 
2.94.   The representative of China  provided the following statement. China appreciates Morocco's 
adoption of international standards. However, the application of the standard for automotive glass 
in Morocco is inconsistent with international practice, which has led to deviation of the test ing results. 
In this regard, it is suggested that Morocco applies the standard in a manner that is consistent with 
international practice, i.e., whether the intermediate layer is torn or not shall be used as a basis for 
judging whether it is necessary to w eigh the fragments of the sample after impact, and not as a 
basis for judging whether the sample is qualified.  
2.95.   In response, the representative of Morocco  provided the following statement. I wish to clarify 
that, in order to  protect consumers, Morocco carries out these checks under Law  No. 24-09 on the 
safety of products and services.  Morocco has already been contacted by the Chinese authority 
regarding automotive glazing checks and we have sent the reply through diplomatic c hannels.  The 
reply provided information on the reference standard used in the automotive glazing conformity 
checks.  This reference standard is Moroccan Standard NM  No. 22.4.003 "Road vehicles - Safety 
glazing materials - Mechanical tests", which is consist ent with UN Regulation No.  43 and with the 
provisions on the 227  g ball test in international standard ISO  3537.  All three of the following 
conditions, rather than just two out of three, must be met in order for the test to be passed:  
(i) condition 1: the ball does not pass through the test piece;  (ii) condition 2: the test piece does 
not break into several pieces;  and (iii) c ondition 3: if the interlayer is not torn, the weight of 
fragments detached from the side of the glass opposite to the point of impac t shall not exceed the 
appropriate values specified by the standard.  Consequently, the test result is considered 
non-conforming if the third condition is not met. As soon as the ball perforates the external glazing 
of the interlayer, the result is consider ed unsatisfactory. This test must also be repeated ten times 
and the results of eight out of ten of the tests must be conforming.  This interpretation is also shared 
by international laboratories.  
2.1.2.19   Kingdom of Saudi Arabia - Concerns on conformity assessment practices of Saudi 
Arabia against Turkish products (ID 68320) 
2.96.   The representative of Turkey  provided the following statement. Turkey regrets that it has to 
bring this item to the agenda of this meeting due to trade -restrictive practices of Saudi Arabia in 
recent months. As Turkey also outlined at the last Council for Trade in Goods meeting, particularly 
since November last year, the restrictive practices against Turkish products have augmented. These 
include unreasonably long delays at Saudi customs and burd ensome and discriminatory product 
safety inspections. We have been informed by Turkish exporters that some Turkish products are 
inspected in accordance with the conformity assessment procedures applied for a different product. 
These products thus fail in c onformity inspections because of the application of improper conformity 
assessment procedures. To exemplify, industrial kitchen equipment is tested in accordance with the 
standards applied to household kitchen appliances. Another such case has been experie nced during 
the conformity assessment of liquid hand soap, which apparently was evaluated as a medical product 
and rejected on the grounds that it did not meet the labelling standards required for medical 
products. Additionally, some Turkish products are r ejected at customs due to problems related to 
 
19 For previous stateme nts follow the thread under ID 682. 
20 For previous statements follow the thread under ID 683. G/TBT/M/83  
 
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  labelling, despite bearing the exact same labelling as before. In one such case, although all warning 
signs stipulated in the relevant technical regulation were included on the product label, the product 
was de nied stating that these signs were not in the sequence shown in the technical regulation. As 
a result of these practices, Turkish products are not allowed to be placed on the market on the 
grounds that they do not comply with the standards specified in the  technical regulation. When 
Turkish exporters uphold that the product in question is interpreted within the wrong product group 
and request a re -testing, this request is also not accepted.  
2.97.   Given all the restrictive practices of Saudi Arabia against Turkish  products, including 
burdensome product safety inspections, Turkish exports to Saudi Arabia decreased by more than 
79% in December 2020 compared to the same month in 2019. We have also witnessed a 93% 
decrease in our exports to Saudi Arabia in January this  year as compared the same month of 2020. 
As known, the TBT Agreement aims to ensure that technical regulations, standards and conformity 
assessment procedures do not create unnecessary obstacles and to prevent Members from creating 
arbitrary or unjustifia ble discrimination between countries in international trade. We are of the 
opinion that Saudi Arabia unjustifiably discriminates Turkish products from any like product of 
national and other Member origin, in violation of the TBT Agreement articles that for esee equal 
treatment of like products. As is well known, the TBT Agreement envisages preparation, adoption 
and application of regulations and conformity assessment procedures so as to grant access for 
suppliers of like products originating in the territori es of other Members under conditions no less 
favourable than those accorded to suppliers of like products of national origin or originating in any 
other country. We are also of the view that Saudi Arabia is in breach of TBT Agreement articles 
foreseeing th at regulations and conformity assessment procedures should not be more strict, or be 
applied more strictly than necessary, taking account of the risks non -conformity would create. In 
this respect, Turkey invites Saudi Arabia to bring its policies and pract ices concerning Turkey in line 
with its WTO TBT obligations and to ensure smooth flow of trade for Turkish goods.  
2.98.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. We take note of all concerns raised and we wi ll convey them to the capital.  
2.1.2.20   Turkey - Eco-design regulation, G/TBT/N/TUR/162 , G/TBT/N/TUR/163  
(ID 68421) 
2.99.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of Turkey to protect the environment and Korean companies are fully committed to 
complying with the regulations of Turkey. Korea would like to make some comments on the Turkish 
Ecodesign regulation of refrigerators, washing machine, dishwasher, display products which is 
scheduled to take effect on 1 March 2021, as Korea had received information from unofficial sources 
that Turkey will implement revised Ecodesign and energy labelling regulations on refrigerators, 
washing machines, dishwashers, and display products from 1 March 2021. Korea enquired about the 
implementation of the regulations and whether  to notify the draft regulations for each product to 
the WTO, and Turkey replied on 10 February that the regulations will take effect on 1 March 2021 
as planned and will be notified to the WTO. Korea also received answers that Turkish Ecodesign and 
energy labelling regulations are almost identical to EU regulations. However, as regulation will take 
effect without any official notification to the WTO, Korean companies will have difficulties that 
sufficient time for complying with this regulation has not been  provided at all. Therefore, Korea 
would like to request that Turkey make official notification of the draft regulations for each product 
to the WTO according to the WTO TBT Agreement and provide a comment period to Members and/or 
a reasonable transition p eriod prior to implementing the regulations after adoption. If it is difficult 
for Turkey to postpone the scheduled enforcement date, Korea would like to request more 
reasonable alternatives, such as temporary recognition or exempting from market surveilla nce in 
order to manufacturers to comply with the regulations.  
2.100.   In response, the representative of Turkey  provided the following statement. The legitimate 
objective of the draft Regulations is to contribute to sustainable development by increasing energy 
efficiency, the level of protection of the environment, and the security of the energy supply. Through 
providing information regarding energy efficiency of the products, the regulations aim to enable 
customers to choose products that are more efficient. Both Energy Labelling and Eco -Design 
Regulations of Turkey have been prepared in line with the EU regulations, since the harmonization 
of the EU's technical legislation is a requirement for Turkey under the EU -Turkey Customs Union 
 
21 For previous statements follow the thread under ID 684. G/TBT/M/83  
 
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  Agreement. Turkey recently con veyed to the WTO the official WTO/TBT notifications of both 
regulations  and provided the full text of the draft regulations in English. These notifications were 
circulated by the WTO on 25 February 2021. Besides, Turkey has also recently submitted the 
notifications of the draft regulations for each product, which will be circulated by the WTO very 
shortly. Concluding my remarks, I would like to reiterate Turkey's willingness to work together with 
the membership to address any specific concerns they may have  on Turkey's Eco -Design and Eco -
Labelling Regulations.  
2.1.3   Previously raised concerns  
2.1.3.1   China - Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercia l encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29422) 
2.101.   The representative of the European Union  provided the following statement. Regarding the 
Multi-Level Protection Scheme, the EU would like to refer to it s comments raised at previous TBT 
Committee meetings, namely concerns around (i) the nature of the expert review that the Guidelines 
prescribe, (ii) the lack of clarity in certain definitions, and (iii) the subsequent unwarranted and 
significant market ent ry restrictions. The EU calls for enhanced proportionality and transparency in 
the implementation of the Cyber -MLPS. The EU also asks China to confirm whether the draft will be 
notified to the WTO for comments, to allow for adequate participation of intere sted parties.  
2.102.   The representative 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 
we made at the last TBT Committee in October 2020. We recognize that the public consultation of 
"Regulation on the Administration of Commercial Cipher Codes " had lasted until 19 September 2020. 
Japan wo uld like to request that China consider the comments we provided and reflect them in the 
regulation. Japan would like to request that China provide relevant information regarding the current 
revision process and that the regulations would be implemented tr ansparently.  
2.103.   In response, the representative of China  provided the following statement. In order to 
implement the requirements of promoting administration in accordance with the law, and to deepen 
the reform of "streamline administration and delegate power s" in the field of commercial 
cryptography, China is revising the Regulations on the Administration of Commercial Cryptography 
in accordance with the legislative spirit of the Law on Cryptography. The revision of the Regulations 
follows the principles of l aw-based, open, transparent and on a scientific basis. Besides, China will 
solicit opinions and comments widely and ensure the stakeholders' participation in legislative 
activities through legal means. Now, as the revision of the Regulation  is still under research, it will 
be open for public opinions in due course. Regarding the MLPS, with technology development, in 
response to more complicated cyber security circumstances, information security multi -level 
protection scheme needs to be improved. Based on pa st experience and responding to new 
development, Cybersecurity Law stipulates that China will carry out the cybersecurity MLPS, which 
is based on information security MLPS. To fulfil the requirements in Cybersecurity Law, the regulation 
on cybersecurity ML PS 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   European Union - Hazard -based approach to plant protection products and setting 
of import tolerances, G/TBT/N/EU/383 , G/TBT/N/EU/384  (ID 39323) 
2.104.   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 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.  
 
22 For previous statements follow the thread under ID 294. 
23 For previous statements follow the thread under ID 393. G/TBT/M/83  
 
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  2.105.   The representative of Costa Rica  provided the following statement. As on previous occasions, 
Costa Rica would once again like to reiterate its support for the trade concern raised by the United 
States, Canada and Australia.  Costa Rica is concerned about th e hazard -based approach adopted by 
the European Union , given that , under the multilateral system obligations,  all technical requirements 
must be based on the relevant international reference standard or a risk assessment providing the 
scientific evidence t o support the measure. Costa Rica reiterates its request to the European Union 
to ensure that the implementation of its regulations is based on the use of risk assessments through 
the application of criteria supported by sufficient scientific evidence, in line with the commitments 
established in the TBT Agreement.  
2.106.   The representative 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 
systematica lly refused to take into account concerns raised by many WTO Members regarding 
notifications G/TBT/N/EU/383  and G/TBT/N/EU/384 . We emphasize that regulations on endocrine 
disruptors should be established 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. A solid risk analysis, consistent with Codex guidelines, is important to ensure 
transparency and predictability in the regulatory processes regarding plant protection products and 
MRLs. Brazil believes that 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 a serious impact on 
trade.  
2.107.   The representative of Canada  provided the following statement. As stated in the previous 
TBT Committee, the importance  of ensuring access to safe and nutritious food has been further 
amplified by the challenges brought on by the current pandemic. In our view, the use of plant 
protection products can play an effective role in addressing some of these challenges while helpi ng 
increase global food security. Canada acknowledges the EU's recent efforts at clarifying the process 
for establishing import tolerances, particularly for active substances that are not re -authorized due 
to the hazard -based criteria or that are no longer  supported by the applicant. Canada is pleased that 
the EU intends to conduct risk assessments for all import tolerance requests, and that such requests, 
including those for active substances that meet the EU's hazard -based criteria, will be impartially 
reviewed in accordance with internationally -accepted risk assessment principles and EU legislation. 
We would like to thank the EU for honouring its commitment to host seminars with third countries 
and stakeholders last month. Canada appreciated the level of detail shared during these discussions 
and welcomed the opportunity to participate and ask questions. While we recognize that the EU has 
a process for import tolerances, Canada requests that the EU consider maintaining MRLs for 
substances that do not pose unacceptable dietary risks. In this context, a dietary risk assessment 
as part of the re -authorization process would likely be needed, regardless of the results of the hazard 
screen. This would eliminate the need for import tolerance requests for some subs tances and 
minimize disruptions to trade. We look forward to continuing our engagement with the EU and 
welcome any information on upcoming regulatory or policy changes to ensure that unnecessary 
trade barriers are minimized and that measures are consistent  with international trade obligations.  
2.108.   The representative of Paraguay  provided the following statement. Paraguay wishes to 
reiterate its deep concern regarding this measure and refers to its statements made at previous 
meetings. 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 due to a lack of conclusive scientific evide nce, 
even in cases where the Codex Alimentarius has identified certain substances as being safe. There 
is a need to consider 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. The European approach to limit the use of pesticides is more trade -
restrictive than necessary to fulfil its legitimate objectives under the TBT Agreement.  We stress that 
the pu rsuance of such policies will cause significant trade damage to the economies of developing 
countries and jeopardize their ability to achieve the Sustainable Development Goals, including those 
related to food security. We urge the EU to reassess its approa ch 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, provide 
adequate transitional periods.  G/TBT/M/83  
 
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  2.109.   The representative of Guatemala  provided the following statement. Guatemala reiterates its 
concern about 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 
management and risk communication).  The precautionary principle is justified 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 using risk analysis for import tolerances, 
particularly for tropical developing countries, where climatic conditions differ from those in the 
European  Union, in that we do not have a harsh winter to help control pests.  Geographical location, 
namely, the distance and time needed to export a product to the European  Union, is another factor 
that should be taken into consideration to avoid applying measures that unnecessarily restrict trade.  
2.110.   The representative of Chile provid ed the following statement. As in previous Committees, 
and like other delegations that have taken the floor before me, Chile wishes to echo the trade 
concern raised concerning the implementation of maximum residue levels set for various agricultural 
produc ts by the European Union, as well as their implementation periods and periods of validity. We 
will continue to monitor developments in this Committee and other relevant committees.  
2.111.   The representative of Colombia  provided the following statement. Colombia o nce again 
shares this concern regarding the approach taken by the European Union (EU) for identifying plant 
protection substances.  As we have stated across different items on the agenda of this Committee, 
we reiterate the need to use risk analysis as a met hodological tool for decision -making under the 
components of assessment, management and communication.  The EU's action shows that risk 
assessment is losing ground, with its decisions 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 measures 
must take into account scientific evidence, production processes and met hods, the international 
recommendations of the Codex  Alimentarius , and the relevant ecological and environmental 
conditions in countries that may be affected by the implementation of the measure, in order to avoid 
creating an unnecessary technical barrier to trade.  
2.112.   The representative of Uruguay  provided the following statement. Uruguay thanks Australia 
and Costa  Rica for once again including this specific trade concern on the Committee's agenda.  We 
wish to support the comments made by the pre ceding  Members and reiterate our trade and systemic 
concern relating to the European  Union's use of a hazard -based approach, instead of an approach 
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 
reiterate the need to base such determinations on conclusive scientific evidence, gath ered from an 
assessment of the actual risks, to avoid some of these active substances , which remain important 
components of pest management systems, being withdrawn despite their safe use. This is due to 
the fact that an approach based on hazard rather tha n 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 agree with Canada on the importance of ensuring and facilitating the access of the 
population to safe and nutritious food, produced in accordance with good agricultural practices, 
especially at the present time.  Uruguay continues to support any multilat eral work undertaken by 
the Codex Alimentarius to develop a harmonized, risk -based approach that ensures the protection 
of health, while facilitating international trade in food products.  In the meantime, we once again call 
on the European  Union to listen to and address the concerns expressed by a number of Members, 
and to reconsider its regulatory approach with a view to preventing the unjustified proliferation of 
barriers to international trade in agricultural products and the serious social and economic 
consequences of such an approach for other Members, in particular developing and least developed  
countries , for which the European  Union is a key market.  
2.113.   The representative of Ecuador  provided the following statement. As this is the first time I 
have taken  the floor, I would like to extend our greetings to all and our thanks to the Chair and the 
WTO Secretariat for the excellent manner in which these meetings have been conducted.  Ecuador 
shares the concerns raised in the statements made by the Members who h ave spoken before me 
regarding this specific trade concern.  My country recognizes the importance of protecting human 
health and the environment. However, we consider that regulatory decisions taken on the basis of 
hazard -based criteria are inconsistent wit h international risk -assessment practices.  Ecuador urges 
the European Union (EU) to take into account scientific information emanating from the international G/TBT/M/83  
 
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  specialized bodies recognized by the WTO, such as the Codex Alimentarius, which has relevant 
information on pesticides.  Ecuador also urges the EU to take into account the recommendations of 
the Committee on Technical Barriers to Trade related to good regulatory practice, particularly with 
regard to carrying out a Regulatory Impact Analysis prior to the issuance of regulatory proposals, 
which examines all possible social, economic, environmental and health impacts. This is to ensure 
compliance with the obligation not to be more trade -restrictive than necessary to fulfil a legitimate 
objective, in acco rdance with Article 2.2 of the TBT Agreement.  Lastly, my country once again calls 
on the EU to ensure that, in cases where there is a lack of scientific information, EFSA does not 
make a recommendation on the maximum residue limit (MRL), since decisions on  regulatory 
measures must be based on conclusive risk analyses that provide real health protection and do not 
constitute a technical barrier to trade.  
2.114.   In response, the representative of the European Union  provided the following statement. 
The European Unio n thanks the WTO Members for their interest in the ongoing work in the EU on 
identifying endocrine disruptors for plant protection products. The EU reiterates that the scientific 
criteria to identify endocrine disruptors for plant protection products based  on the WHO definition 
are applicable since 10 November 2018 onwards and included in Regulation (EU) No 2018/605. We 
are aware of general concerns on EU policy on plant protection products for the definition of scientific 
criteria to identify endocrine dis ruptors and on the establishment of import tolerances for substances 
not authorised in the EU, due to the so -called "cut-off" criteria in Regulation (EC) No 1107/2009. As 
previously explained, the European Union decided to follow the procedures of Regulati on (EC) No 
396/2005 for the management of import tolerance requests concerning active substances falling 
under these cut -off criteria, which include a risk assessment by an Evaluating EU member State and 
a scientific opinion by the European Food Safety Aut hority (EFSA). The granting of the import 
tolerance is then 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 
keep Members  duly informed about future developments.  
2.1.3.3   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1313  (ID 42824) 
2.115.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to thank China for the notification G/TBT/N/CHN/1313 . Korea has continuously engaged with 
China on the Regulations for the Supervision and Administration of Medical Devices. With the 
notification, the draft of the revision of the regulation was announced in 2019. With regard to the 
Regulations, Korea has repeatedly requested China since 2015 to accept the test results of 
laboratories outside China in applying for cosmetic registration in China, but no clarified explanation 
has been given from China. Thus, we would like to reitera te the concerns as follows. Korea requests 
China to accept the test results from laboratories outside China. Specifically, internationally 
accredited laboratories outside China should be recognized by the National Medical Products 
Administration (NMPA). Th is would reduce compliance costs, thereby facilitating trade. Korea would 
like to be informed about the time frames for the publication of the final Regulations and their entry 
into force.  
2.116.   In response, the representative of China  provided the following sta tement. At present, 
"Regulations on the Supervision and Administration of Medical Devices" is still under revision. While 
the whole process is completed, China will promptly publicize the regulation.  
2.1.3.4   China - Cyberspace Administration of China – Draft imple menting measures for 
the Cybersecurity Review of Network Products and Services (ID 53325) 
2.117.   The representative of the European Union  provided the following statement. The EU has 
raised the Security Review of Network Products and Services, including the Cyber security Review 
Measures, in this Committee on several occasions, stressing our concerns related to these measures, 
which entered into force on 1 June 2020. We remain concerned that the measures are quite general 
and very broad discretionary powers are lef t to the authorities in charge of the security review, 
raising concerns for foreign ICT operators. The measures are directed towards the purchasing 
activity of Critical Information Infrastructure (CII) operators by encouraging operators to apply for 
review s in the case that they deem their purchase or procurement may pose a risk to Chinese 
 
24 For previous statements follow the thread under ID 428. 
25 For previous statements follow the thread under ID 533. G/TBT/M/83  
 
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  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 re views. The EU urges 
China to ensure clarity, transparency and objectiveness in the security review so that the measure 
does not become a new market access barrier. The EU also seeks an update of this measure from 
China.  
2.118.   The representative of Japan  provided  the following statement. Japan has its interest in and 
concern with regard to the Cybersecurity Review and would like to refer to the previous statement 
we made at the last TBT Committee in October 2020. At the last TBT Committee, China explained 
that Cyb ersecurity 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 Chinese 
market. Japan would like to request that China provide relevant information regarding the current 
revision process and that the regulations would be implemented transparently.  
2.119.   The representative of Canada  provided the following statement. Canada remains concerned 
by the absence of the following in the Implementing Meas ures for the Cybersecurity Review: 
(i) clarity regarding what constitutes Critical Information Infrastructure; (ii) defined criteria that 
operators of Critical Information Infrastructure are to use in assessing a security threat; and (iii) a 
clear commitme nt to national treatment, MFN treatment and the use of international standards. 
Canada continues to believe that the definition of Critical Information Infrastructure is an open -
ended, imprecise list of broad sectors, which does not permit operators to ass ess adequately whether 
their infrastructure is critical information infrastructure. In addition, Canada is of the opinion there 
is no clear commitment to the use of the international standards that exporters, from all countries, 
depend upon to construct th e supply chains that underpin international trade. Canada shared 
detailed comments to China on these implementing measures in June 2019, and to date, Canada 
has not received any response. Does China intend to respond to Members' comments at some point? 
Canada continues to look forward to receiving a response from China. Furthermore, is China 
considering formally notifying the measure under the TBT Agreement? Any additional information 
that China is able to share with the Committee today would be most welcom ed. 
2.120.   In response, the representative of China  provided the following statement. In recent years, 
with the development of network information technology, more and more network products and 
services have entered into the key information infrastructure field t o serve the operation. However, 
at the same time, some take the advantage of providing network products and services to obtain 
important data of users illegally, to control and interfere with the key information infrastructure 
operation, for non -technical or commercial reasons, to stop the supply of technology, products, and 
services, which brings great risks and challenges to national network security. In order to adapt to 
the present situation and safeguard the national network security, especially the su pply chain 
security of key information infrastructure, the Cybersecurity Law  clearly requires the establishment 
of a security review system. In April 2020, the relevant authorities issued Cybersecurity Review 
Measures, and the former Cybersecurity Review o f Network Products and Services has been repealed 
at the same time. "Cybersecurity review measures" provide an important institutional guarantee to 
carry o ut the review. The establishment and implementation of network security review system are 
not to rest rict or discriminate against foreign products and services. Opening up is China's 
fundamental national policy. As always, China welcomes foreign products and services to enter the 
Chinese market in compliance with the requirements of Chinese laws. In addit ion, China has always 
adopted a responsible attitude to actively promoting IPR protection. Business secrets, intellectual 
property rights and other undisclosed information are fully under protection in the process of review.  
2.1.3.5   European Union - Amendments to the Directive 2009/28/EC, Renewable Energy 
Directive (ID 55326) 
2.121.   The representative of Colombia  provided the following statement. Colombia wishes to 
reiterate its ongoing concern regarding Directive (EU) 2018/2001 of the European Parliament and 
Council, whi ch provides  that, as from 2021, first -generation biofuels will account for a share of no 
more than 7% in the transport sector, and that first -generation biofuels posing a high risk of indir ect 
land use change (ILUC) will  have their contribution to the rene wable 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 GATT 1994 and Article 2.1 and 2.2 of the WTO TBT Agreement.  
We therefore reaffirm the d etailed arguments that have been presented at the TBT  Committee 
 
26 For previous statements follow the thread u nder ID 553 (under dates raised and references) . G/TBT/M/83  
 
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  meetings concerning this matter, which appear in document G/TBT/W/714  dated 2  March  2020.  
Colombia 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, and to review the use of other raw materials with a more severe negative impact than palm 
oil on deforestation.  We have been asking the EU for a number of months to share information on 
the internal process to review the delegated act, with no response. In fact, we have learned that the 
Committee has already taken steps to hold consultations, in line with its internal procedures, but it 
has not informed the partners concerned about the se or submitted the relevant  notification to this 
Organization.  We would like to take this opportunity to express our concern regarding the regulatory 
process followed by the European Union in this matter and the gaps in the logical process of 
promulgation  of these regulations. In particular, we see that the Directive and its delegated act do 
not correlate with the stated policy objective of environmental protection, and even appear to offer 
perverse incentives that may lead to greater and worse deforestati on and more greenhouse gas 
emissions.  While we understand that some of these matters are being addressed under WTO dispute 
settlement procedures, we reiterate our request for information on the internal process to review 
standards, which has been undertake n without taking into account the comments submitted.  
2.122.   The representative of Guatemala  provided the following statement. We thank Colombia for 
including this item on the agenda. The systemic concern regarding this measure has been noted and 
will be followe d up accordingly.  
2.123.   In response, the representative of the European Union  provided the following statement. As 
indicated in many previous meetings, this issue of amendments to the EU Renewable Energy 
Directive is now subject to WTO dispute settlement proceed ings, notably under DS593 (EU – Certain 
measures concerning palm oil and oil palm -based biofuels) as brought by Indonesia and DS600 (EU 
and certain Member States — Certain measures concerning palm oil and oil palm crop -based 
biofuels) as brought by Malaysi a. In order to preserve the integrity of such proceedings, the 
European Union will defer all discussions to these fora and accordingly refrain from discussing this 
matter in this Committee.  
2.1.3.6   European Union - Draft Commission Regulation laying down eco -desig n 
requirements for electronic displays pursuant to Directive 2009/125/EC of the European 
Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and 
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes) , 
G/TBT/N/EU/609  (ID 57527) 
2.124.   The rep resentative of China  provided the following statement. China thanks the EU for the 
reply in previous meetings, and after a study of the accompanying annexes, China suggests EU to 
delete or suspend the ban of halogenated flame retardants in D4 of Annex II. In EU's eco -design 
regulations and its accompanying annexes which closed public consultation in November of 2020, 
the above banning requirement is elaborated as: the determined value for such homogeneous 
material attributable to flame retardants shall not exceed, as 0.1% by weight of bromine, 0.1% by 
weight of fluorine, and 0.1% by weight of chlorine. These thresholds are not consistent with EU 
RoHS. The Eco -design sets the threshold value on some elements, while EU RoHS sets on specific 
flame retardants li ke PBB or PBDE. Plastics usually contain various additives, therefore not only 
flame retardants may contain halogens, some other additives may also contain halogens. Although 
it is stipulated that the thresholds are set for fluorine, bromine and chlorine a ttributable to flame 
retardants, in practice it is difficult to differentiate to which additives fluorine, bromine and chlorine 
are attributable. International Bromine Council (BSEF) recently released the Study on the Impacts 
of Brominated Flame Retardants  on the Recycling of WEEE plastics in Europe by leading consultancy 
SOFIES. One of the key findings from the Study is: the presence of BFRs (Brominated Flame 
Retardants) in WEEE plastics does not reduce recycling yields than other FRs (Flame Retardants) in  
FR-containing plastics. In addition, plastics containing other additives in significant loads (e.g. 
fillers), are also sorted out in the conventional density -based recycling process. This research has 
shaken the basis of banning the halogenated flame reta rdants in e -displays in EU eco -design. China 
suggests that the EU re -evaluates the scientific nature of this term.  
2.125.   In response, the representative of the European Union  provided the following statement. As 
explained at previous Committee meetings, the lega l basis for this amending act is provided by 
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009, 
 
27 For previous statements follow the thread under ID 575 (under dates raised and references) . G/TBT/M/83  
 
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  establishing a framework for the setting of eco -design requirements for energy -related products. 
Energy -related products ac count for significant volumes of sales and trade in the Union, have a 
significant environmental impact and present significant potential for improvement through design 
in terms of their environmental impact, without entailing excessive costs. Unless otherw ise specified, 
the requirements of the Stockholm Convention are "de minimis " provisions, allowing parties to adopt 
their own measures with a higher level of environmental ambition. The proposed Eco -design 
requirement restricting the use of halogenated flam e retardants 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 i n the detailed Impact Assessment carried out prior to the adoption of the 
initial regulatory act.28 
2.1.3.7   Colombia - Food Prioritized for its Sodium Content, Certification Requirements  
G/TBT/N/COL/238 , G/TBT/N/COL/238/ Add.1 , G/TBT/N /COL/238/Add.2  (ID 60929) 
2.126.   The representative of Costa Rica  provided the following statement. Costa Rica reiterates its 
concern regarding the proposed Colombian Technical Regulation establishing the maximum sodium 
content for a prioritized list of a broad r ange 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 firmly believes in implementing strategies aimed at 
protec ting public health by reducing the underlying factors of arterial hypertension and related non -
communicable diseases.  However, it is concerning that the proposed maximum sodium levels for 
the selected products are not substantiated by scientific evidence. Costa Rica also does not consider  
them to be 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 establi shed for each product, so as to facilitate our analysis of the legislation.  We 
would be grateful if the delegation of Colombia could provide us with information on the status of 
this Regulation and the possible date for its entry into force.  
2.127.   The representa tive of the European Union  provided the following statement. The European 
Union would like to thank Colombia for the clarifications provided with regard to this notification. 
The European Union would like to reiterate 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 high 
blood pressure and other associated diseases. The European Union would like to ask for further 
clarifications with regard to Article 8 of the  Resolution No. 2013 of 2020, adopted on 7 November 
2020. First, the European Union does not require mandatory third party certificates for sodium 
content. Could Colombia confirm that certificates issued by conformity assessment bodies 
established in the E U would be accepted under the point 8.2, as the reciprocity requirement is not 
relevant in such situation? Second, the EU invites Colombia to clarify the meaning of the last 
paragraph of Article 8. Does it mean that until a first conformity assessment body  is accredited in 
Colombia to issue certificates according to this regulation, a first -party declaration of conformity will 
be accepted? Finally, the European Union would like to invite Colombia to provide timely guidance 
to food manufacturers and importer s to help them prepare for the implementation of the new 
technical regulation.  
2.128.   The representative of Guatemala  provided the following statement.  The Technical Regulation 
seeks to establish the maximum sodium content for the food prioritized under the Natio nal Strategy 
for the Reduction of Sodium 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 recognizes the legitimate objective of 
the Colombian authorities to ensure human health, and the efforts made to reduce hypertension, 
and, in accordance with the technical regulations notified, to establish a maximum sodium content 
for certain proces sed foods. A revision was made to the Technical Regulation approved by Resolution 
No. 2013 of 2020 notified in document G/TBT/N/COL/238/Add.2  of 22 January 2021, which advised 
of the adoption of the Regulation on 9  November  2020.  The Resolution states that, in order for  a 
product to be put into circulation or imported, a third -party certificate of conformity must be obtained 
from an accredited entity to demonstrate compliance with regulatory requirements, which we 
 
28 https://eur -lex.europa.eu/legal -content/e n/TXT/?uri=CELEX:52019SC0354   
29 For previous statements follow the thread under ID 609. G/TBT/M/83  
 
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  continue to consider as an unnecessary barrier to interna tional trade. Guatemala therefore requests 
the Government of Colombia to consider first -party conformity assessments.  
2.129.   In response, the representative of Colombia  provided the following statement. We thank  the 
EU for the advance submission of the questions and comments on this STC, and Costa Rica and 
Guatemala for their statements. It is a matter on which Colombia has been in constant dialogue with 
all WTO Members that have submitted comments.  Regarding the question on whether certificates 
issued b y conformity assessment bodies established in the EU would be accepted under item 8.2, 
the answer is yes, provided that they belong to the International Accreditation Forum 's (IAF) mutual 
recognition agreements (MRAs). For example, the certification bodies  of the European co -operation 
for Accreditation (EA) are part of these agreements and would therefore be accepted.  With respect 
to the second point mentioned, the reply is also yes, the first -party certificates will be accepted for 
up to 24 months after a certification body is accredited in Colombia. Currently, the country does not 
have certification bodies accredited with the scope of this technical regulation. However, this 
information can be viewed via the link  below.30 Lastly, on Colombia 's side, the TBT contact point and 
the Ministry of Health and Social Welfare will provide all the necessary guidance and information for 
the implementation of the technical regulation.  
2.1.3.8   Russian Federation - Law No. 425 - on Amending Article 4 of Russian Federation 
Law " On Protecting Consumer Rights" (ID 61231) 
2.130.   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 pr e-installation of Russian software on "technically complex 
goods " (TCGs) sold in Russia. Our understanding is that the current implementation deadline is 1 
April 2021. While this deadline is quickly approaching, many concerns and questions remain. We 
prese nted our concerns to Russia in writing in March 2020 and raised them again during the 2020 
meetings of the TBT Committee, but Russia has not yet provided an adequate response. Russia has 
continually 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 p roduct characteristics and production methods for technically 
complex goods 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 regulat ion. 
2.131.   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 develop ers to electronic devices. 
Many of the technically complex goods targeted by this technical regulation already feature software 
from Russian developers and include app platforms which encourage participation by Russian 
companies. We ask Russia to provide e vidence that Russian developers are being denied access to 
develop software for technically complex goods. We also ask Russia to explain how the requirement 
is not more trade restrictive than necessary and does not create unnecessary obstacles to trade. As  
we have stated before, we urge Russia to notify these implementing regulations to the TBT 
Committee, to allow reasonable time for stakeholders to make comments in writing, to discuss these 
comments upon request, and to delay implementation of the measure until such written comments 
and the results of such discussions may be taken into account. Finally, we request that Russia 
provide a reasonable period of at least six months between publication of any amended regulation 
and its entry into force.  
2.132.   The repres entative of the European Union  provided the following statement. The European 
Union has concerns on amending article 4 of the Russian Federation Law "On Protecting Consumer 
Rights", which mandates pre -installation of Russian software. These include mainly certain 
discriminatory aspects as well as the questionable proportionality of the measure. Moreover, we call 
on Russia to comply with its WTO transparency 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.  
 
30 https://onac.org.co /directorio -de-acreditados  
31 For previous statements follow the thread under ID 612 (under dates raised and references) . G/TBT/M/83  
 
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  2.133.   The representative of Japan  provided the following statement. Japan would like to share 
concerns regarding this measure expressed by the US. This proposed measure includes unclear 
articles regarding de finitions of terms, concrete requirements for review and evaluation, and the 
scope of regulations including covered software list. Japan's concern is that the measures may 
hamper market access for foreign companies in Russia, depending on the concrete deta ils 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 reque st that Russia notify this measure and the relevant 
regulations to the TBT Committee to ensure transparency of the procedure.  
2.134.   In response, the representative of the Russian Federation  provided the following statement. 
Russia is convinced that this measure cannot be considered as the technical regulation under 
Annex  1 of the Agreement on Technical Barriers to Trade and reiterates its statements made at the 
previous meetings of the Committee on TBT. Also, we would like to inform Members that the measure 
enter s into force on 1 April 2021 instead of earlier proposed date of 1 June 2020. The decision on 
postponement of the date of entry into force of this Law was made, inter alia , at the request of 
foreign stakeholders. We consider this period as sufficient for s uch stakeholders to adapt to this 
legislation.  
2.1.3.9   Bangladesh - Hazardous Waste (E -waste) Management Rules, 2019, 
G/TBT/N/BGD/3 , G/TBT/N/BGD/3/Add.1  (ID 62032) 
2.135.   The representative of the United States  provided the following statement. The United States 
again acknowledges that Bangladesh notified the Hazardou s Waste (E -waste) Management Rules, 
2019, including a summary, excerpted translation of two clauses, and a threshold limits schedule 
for the management of electronic waste products. However, because Bangladesh did not notify the 
entire text of the proposed  E-waste rules, stakeholders cannot fully evaluate the changes from 
previous versions. We again ask that Bangladesh submit the full text of the measure to the WTO 
TBT Committee, provide a public comment period of at least 60 days, and take such comments in to 
account before finalizing the measure. Can Bangladesh provide an update on the implementation 
status of the draft E -waste rules? The United States is concerned that by restricting 15 substances 
and broad categories of substances, the draft rules may dis rupt or prevent the sale of many 
important electrical and electronic goods in Bangladesh, including certain medical devices, liquid 
crystals for liquid crystal displays, and PVC parts for washing machines. Given the broad definition 
of some of the restrict ed categories, such as "copper beryllium alloys, " the draft rules may disrupt 
the supply of cellular telephones. The draft rules also appear to lack provisions for the use of certain 
restricted substances where there are no substitutes, such as lead shield ing for X -ray equipment.  
2.136.   Additionally, the proposed rules appear to ban the import of used or refurbished electrical 
and electronic equipment. The proposed rules do not indicate whether industry will be able to import 
refurbished and repaired electrical an d electronic equipment, a practice which could extend the 
operational life of millions of dollars of valuable equipment. In view of the potential disruption this 
measure may have on the sale of many important electrical and electronic goods in Bangladesh, has 
the Ministry of Environment, Forest and Climate Change consulted with other relevant Bangladeshi 
ministries, such as the Ministry of Health and Family Welfare and the Ministry of Commerce, to 
ensure that the rules accomplish the intended regulatory obj ectives without creating unnecessary 
obstacles to trade?  
2.137.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statements made during the previous regular meetings of the TBT 
Committee regardin g the draft Hazardous Waste Management Rules of Bangladesh notified in 
documents G/TBT/N/BGD/3  and G/TBT/N/BGD/3/Add.1 . The draft rules establish a list of 
"hazardous" substances restricted for use in enlisted categories of electrical and electronic products. 
However, the document does not provide any e xplanation as to what criteria have been used to 
identify hazardous substances and the reasons to set specific levels for each substance. Some 
substances, like nickel, should not be classified as hazardous in this regulation and should not be 
subject to an y restrictions, as there is no scientific, including laboratory and epidemiological, 
justifications for this. Russia sent detailed comments on the draft rules to the Bangladesh TBT 
enquiry point on 10 March 2020 and we still expect substantive feedback on these comments. Russia 
 
32 For previous statements follow the thread under ID 620. G/TBT/M/83  
 
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  encourages Bangladesh to share with the Committee information on the developments in the drafting 
of the Hazardous Waste (E -waste) Management Rules.  
2.138.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to make some comments regarding this regulation as follow. Korea highly regards the efforts of 
the Bangladesh and competent authorities to introduce electronic waste management rules for 
protecting the environment and managing recycling resource s. Furthermore, Korean companies are 
committed to fully comply with the rules of Bangladesh. However, as Korean companies have raised 
the following concerns regarding the proposed rules of Bangladesh, we would like to request that 
Bangladesh take into cons ideration these concerns and take appropriate actions. We would also like 
to emphasize that the same comments were made at the 3rd WTO TBT Committee Meeting in 2020, 
but there has been no response since then. First, no specific enforcement date has been pr ovided 
for these proposed rules. Although their enforcement date has been stipulated as within 2020, 
compliance with these rules may be difficult if they suddenly enter into force without any prior notice. 
Therefore, Korea would like to ask Bangladesh to p rovide us an interval of more than six months 
between the publication of regulation and their entry into force, and we ask Bangladesh if there is 
any information regarding the specific date of enforcement.  
2.139.   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 scient ific 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 
stipulated 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 to the total amount of the hazardous substances.  
2.140.   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. To that end, Canada 
would refer to its previous statements on this STC, and ask if Bangladesh is now in a position to 
share new information and additional supportive documentation on the draft Management Rules, 
including timelines for consultations on the full regulatory text. Canada notes that the proposed date 
for entry into force of the rules, as identified in Bangl adesh notification, referred to the year 2020. 
Now that we are in 2021, could Bangladesh provide any indication regarding the timeframe for the 
implementation of the rules, and that it will take place at least six months after final publication of 
the rule s? 
2.141.   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 
Bangladesh in April 2020 and are looking forward to receiving written replies  before the adoption of 
the notified drafts. Our main point is that the notified draft restricts use of substances that are not 
restricted by any existing international legislation and thus creates more restrictions to trade than 
necessary. The EU would be  grateful if the above -mentioned comments could be taken into account 
and replied to before adoption of the notified draft.  
2.142.   The representative of Bangladesh  did not provide a response to the concerns raised. These 
concerns were subsequently transmitted to the relevant authorities.  
2.1.3.10   India - Draft Chemicals (Management and Safety) Rules, 2020 (ID 62233) 
2.143.   The representative of the United States  provided the follo wing statement. We refer to 
previous statements on this measure and continue to have concerns.  
2.144.   The representative of Canada  provided the following statement. Canada would like to refer 
to its previous statement from the October 2020 TBT Committee meeting.34 Canada remains 
concerned that, despite numerous requests, India has yet to notify this measure to the TBT 
Committee. Can India provide an update on when it expects to formally notify the measure and 
 
33 For previous statements follow the thread under ID 622. 
34 G/TBT/M/82 , paras 2.192 and 2.193.  G/TBT/M/83  
 
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  allow WTO Members and stakeholders an appropriate perio d for comments, as per India's obligations 
under the TBT Agreement?  
2.145.   The representative of Japan  provided the following statement. Japan would like to request 
India to clarify the timeline for notification of India's Draft Chemicals (Management and Safety) 
Rules to the WTO TBT Committee. Japanese industry has concerns on the Draft Chemical Rules due 
to its potential to strongly influence export and sales in India. Japan would like to request India to 
ensure enough time for comment after notification and to c onsider opinions from all stakeholders.  
2.146.   In response, the representative of India provided the following statement. The Draft 
Chemicals (Management and Safety) Rules 2020 has been circulated among the industry 
associations. Extensive stakeholder consultatio n is being done to finalize the draft before putting it 
up on the WTO TBT website with a reasonable comment period.  
2.1.3.11   Australia - Maturation requirements for imported alcohol (ID 63635) 
2.147.   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 that are currently in force are more trade -restrictive than 
necessary to protect such legitimate objectives. 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 brand y, rum, and whisky, it encompasses tariff line 2208.40.00 (rum 
and other spirits obtained by distilling fermented sugarcane products), under which cachaça is 
classified in Australia. By granting the same treatment to cachaça and rum, the Australian 
Governm ent does not allow imports of cachaça that are not matured for at least 2 years in wood. 
Such a requirement does not relate to any quality standard or sanitary requirement applicable to 
cachaça.  
2.148.   Following a public consultation in late -2019, the Australian Border Force (ABF) further 
explored a potential avenue to amend the Customs Act 1901 (Customs Act) that would enable 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 looking to retain Australia's existing 
maturation requirement for imported brandy, whisky, and rum, but would establish a list of products 
exem pt from this maturation requirement. The proposed list of exempt products would include 
Cachaça and Pisco and Bourbon. 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. We support the creation of a list of exceptions to the rules set out today in 
section 105A, thus allowing certain cultural and geographical indications (i.e. Cachaça) that are not 
traditionally described as brand y, whiskey or rum to be imported into the Australian market. In order 
to avoid any confusion in the Australian market or among Australian consumers, we support that 
none of the sugar -cane products imported to Australia (matured or unmatured) that are not 
specifically "rum" should be labelled or marked as "rum". In previous interventions regarding this 
STC, Australia has failed to provide clarification on a few points: Could Australia please confirm if 
this new regulation will also establish new labelling re quirements for products other than rum, 
brandy and whisky? Could Australia provide timeframes for the publication of the final text? Could 
Australia indicate why it has not notified said public consultations to the TBT Committee? We look 
forward to continu ing our bilateral engagements with Australia on this matter. Brazil will continue to 
raise this STC until current maturation requirements for imported alcohol no longer apply to cachaça.  
2.149.   In response, the representative of Australia  provided the following s tatement. We thank 
Brazil for its interest 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 applies 
equivalent requirements on domestic manufac tured 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. These 
requirements are applied through the Excise Act 1901 and Customs Act 1901 (Customs Act) 
respectively. Australi a is continuing to review its legislative framework for the importation of 
 
35 For previous statements follow the thread under ID 636. G/TBT/M/83  
 
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  unmatured alcohol products under section 105A of the Customs Act. The review process is 
considering potential pathways to enter unmatured spirits without undermining Australia's con sistent 
approach to maturation requirements. In November 2020, the Australian Government undertook a 
stakeholder consultation, through the release of a consultation paper, to seek views on a refined 
proposed approach to amend section 105A of the Customs Ac t. The consultation paper was sent 
directly to the participants of the previous consultation sessions, including the Brazilian Embassy in 
Canberra and is available on the Department of Home Affairs Website.36 The Government will 
consider potential reforms following the outcome of this consultation. Any proposed changes will be 
notified to the Committee in accordance with our obligations under the TBT Agreement. Australia 
acknowledges Brazil's engagement on the review of Australia's maturation requirements f or alcohol. 
Representatives from the Brazilian Embassy participated in both the 2019 and 2020 consultation 
processes, led by the ABF. The ABF is taking the issues raised by Brazil into consideration as part of 
the reform process.  
2.1.3.12   Kingdom of Saudi Arabia, K ingdom 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   (ID 64337) 
2.150.   The representative of the European Union  provided the following statement. The European 
Union would like to thank the GCC countries and Yemen for providing an opportunity to WTO 
Members to comments on the draft GCC Technical Regulation on Halal Feedstuff a nd refers to its 
written comments of 12 June 2020. The European 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 f or imports of animal products certified and labelled as 
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 a condition would require a significant alteration to the feeding regime 
for food -producing animals in the EU and would negatively affect EU exports. The EU would also like 
to enquire about the timeline for adoption and implementation of the draft including the grace period 
that would be applied. The European Union remains available to discuss this issue.  
2.151.   The representative of the United Sta tes provided the following statement. The US supports 
the statement made by the EU.  
2.152.   In response, the representative of the Kingdom of Bahrain  provided the following statement. 
I deliver this statement on behalf of the member states of the Gulf Cooperation Council. We would 
like to thank the United States and the European Union for their valuable comments, which have 
been sent to their respective TBT Enquiry Points, and is pleased to clarify the following. The draft 
regulation "Halal Feedstuff " covers the re quirements to be followed in the production, preparation, 
handling, transport and storage of Halal feed for food -producing animals. This draft regulation is 
under review at GSO level and it is not intended to result in trade restrictions. It is rather base d on 
Islamic laws and covers the Halal requirements which must be abided by during the production of 
feed for food -producing animals. In regard to meat products, please refer to GSO -993:2015 (Animal 
Slaughtering Requirements According to Islamic Rules), wh ich stipulates that "animals should be fed 
forages from Halal sources " as a requirement for slaughtered animals. The GCC member states 
would like to invite interested Members to discuss this matter bilaterally.  
2.1.3.13   India - Indian standards and import restricti ons 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  (ID 64938) 
2.153.   The representative of the European Union  provided the following statement. India has 
adopted a number of measures in the automotive sector that raise important concerns across the 
EU industry. These Quality Control Orders in the automotive sector regard mandatory markings for 
wheel rims, new standards for safety glass, and BIS compulsory certification for helmets for two 
wheeler riders. All three notifications from India foresaw only 3 0 days for comments. The EU recalls 
 
36 www.home affairs.gov.au/reports -and-publications/submissions -and-discussion -papers   
37 For previous statements follow the thread under ID 643. 
38 For previous statements follow the thread under ID 649. G/TBT/M/83  
 
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  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 recommend ation 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. The EU would like to 
underline that all measures in question have protectionist orientation and are sending very worrying 
signals to EU industry, EU inve stors 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.  
2.154.   As regards the wheel rims, t he draft Quality Control Order (QCO) issued by the Department 
of Heavy Industries (DHI) would make mandatory ISI marking on all automotive wheel rims. It is 
important to highlight that substantively the Quality Control Order is very similar to established 
international standards with which all EU exports already comply, the main element introduced by 
the Order being the ISI mark. The QCO therefore will generate important additional  costs for 
European automotive manufacturers while the qualitative reasons fo r the introduction of such a 
measure are not evident. The EU would therefore like to ask India to reconsider the introduction of 
this QCO. Furthermore, the EU would like to stress that BIS markings should be optional for 
components which are already in com pliance 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 Regulation 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. The EU would like to suggest to India to keep t he BIS marking as optional for 
components, which are already in compliance with the current marking requirements.  
2.155.   The European Union appreciates the decision to postpone the introduction of the mandatory 
Indian Standards Institution (ISI) marking for autom otive Safety Glasses to April 2021. According 
to the new Quality Control Order, automotive glass not mounted in vehicles (loose or spare parts) 
sold in India will have to obtain a new national licence and marking. Despite the delay of the entry 
into force,  the European companies face important difficulties to prepare for the new certification 
system due to extraneous factors related to the pandemic that are not within their control. In order 
to obtain the ISI marking, the Quality Control Order mandates an i n-person audit by auditors from 
BIS on the basis of a rather cumbersome application process requiring local presence. EU companies 
have nonetheless complied and made the necessary applications, however the prohibition to travel 
from and to India due to the  COVID -19 restrictions makes physical audits difficult to envisage in the 
coming months. EU companies require a timeline of 4 months from the completion of the audit to 
ensure the certified product on the factory floor. Taking into account the time require d for retooling, 
production and shipping, an entry into force on 1 April 2021 implies that rapidly, imports of safety 
glass will come to standstill with important economic impact on auto production plants.  
2.156.   While acknowledging the purpose of Bureau of India n Standards (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 is difficult for EU companies to comply with the new requirements 
within the deadlin es set by the Quality Control Order. Furthermore, the new requirements generate 
additional costs to EU automotive glass manufacturers, as they would require complex procedures 
such as audits, tooling changes, etc., without clear qualitative improvements. I n this light, the 
European Union would like to ask India to reconsider the implementation of the Quality Control 
Order. The European Union would like to request India to at least further delay the entry into force 
of this measure, so that the EU industry m ay fully comply with the Order. This would allow the EU 
companies to meet the requirements and to continue supplying customers in India. Finally, the EU 
would urge India to consider virtual audits or audits by recognised third party certification experts 
in the location of the manufacturing plants. The Quality Control Order on Protective Helmets for Two 
Wheeler Riders is now set to come into force on 1 June 2021. The EU welcomes this delay in its 
implementation. The EU would like to request India to keep th e BIS marking as optional for 
components, which are type approved according to UN Regulation 22 concerning the approval 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 reconsider the mandatory introduction of 
Quality Control Orders on the wheel rims, automotive safety glass, and helmets.  
2.157.   In response, the repre sentative of India provided the following statement. Safety Glass . The 
QCO on Safety Glass was issued on 12 March 2020 with its implementation date of 16 September G/TBT/M/83  
 
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  2020. Further, it was extended for implementation with effect from 1 April 2021.  The QCO has  been 
amended on 18 September 2020, which states that safety glass used in the vehicle imported in India 
by vehicle manufacturer under the provisions of rule 126 of Central Motor Vehicle rules, 1989 are 
not covered under QCO of safety glass. Wheel Rims . The testing and certification system in India is 
in line with the global regime. The component certification is an important pre -requisite of Whole 
Vehicle Type Approval and the two are complementary. This practice is well established worldwide 
and quite har monized under Whole Vehicle Type Approval. Unlike in European Union, where the 
wheel rim is not identified as a separate safety -critical component in UNECE, in India, the wheel rim 
is identified as one under CMVR. This has been warranted keeping in view th e local road 
infrastructure, variety of tyres used and driving behaviour in India. Wheel rim is a critical part of 
influencing driving safety. These Indian standards have been prepared to ensure the quality, 
reliability and consistency required, keeping in  view human safety and consumer protection. These 
standards prescribe the general and performance requirements of wheel rims intended for use on 
two, three, and four -wheeled motor vehicles. The Quality Control Order (automotive wheel rims) is 
non-discrimin atory in nature, both at the original fitment level of automobiles as well as in the after -
sales/repair service, to ensure supply of only quality product in the Indian market duly certified and 
approved by Indian implementing agency. The QCO also provides for market surveillance in order 
to check entry of sub -standard product into the Indian market. This was necessitated to protect 
human life and consumer interest. The Quality Control Order was issued after due consultation with 
stakeholders. Further, as de sired 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.  
2.158.   Helmets QCO . India is the largest two -wheelers market in the world. Arou nd 15 million two -
wheelers are sold in the country every year. Also, the fatalities due to road accidents i.e., around 
1.5 lakhs per year, are the highest in the world, which is about 11% of the total global road accident 
fatalities. And further, the death s involving two -wheelers are a significant number, and further 
fatalities without helmets or helmets of low quality are also very high. The Government and the Apex 
Court, i.e, Supreme Court, focus hard on policies and measures to make people wear proper he lmets 
while riding two -wheelers. In this regard, there was a move to reduce the helmets' maximum weight 
so that people should use helmets and BIS had issued the notification in this regard which prescribed 
for the max weight of helmets to 1200 from earlier  1500 grammes. But due to the demand from the 
foreign helmet importers, the cap on weight from 1200 was extended to 1500 grammes. Now there 
is a proposal for including helmets in the compulsory certification regime. This will ensure that the 
helmets are ma nufactured or imported only with the specifications of BIS standard and would ensure 
good quality helmets, ensuring proper protection and reducing fatalities. The BIS provides for a 
mechanism for the foreign manufacturers to obtain BIS certification, which  enables them to sell in 
India. Considering India's road safety scenario as above, which is quite different from any European 
countries, the requirements for certified helmets are a high priority.  
2.1.3.14   China - Encryption Law of the People's Republic of China by  the Office of State 
Commercial Cryptography Administration (OSCCA) (ID 53439) 
2.159.   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 f oundational concepts as well as administrative procedures described in the text. Both of 
these factors will negatively impact business confidence. The EU notes with concern that the new 
law does not recognise China's previous commitment made in 2000 that t he cryptography -related 
regulation would only apply to products whose core function is that of providing encryption – the so -
called "Year 2000 Clarification" by the State Cryptography Administration (SCA). The EU calls on 
China to ensure that legal and reg ulatory requirements are based on a non -discriminatory basis, do 
not favour specific technologies, do not limit market access and do not lead to a forced transfer of 
intellectual property. The EU urges China to guarantee the possibility for foreign -investe d enterprises 
(FIEs) to participate on an equal footing with domestic companies in the production, research, 
development and sale of cryptography products on its market.  
2.160.   The representative of the United States  provided the following statement. The US conti nues 
to be concerned, and supports the statements of the EU and Japan.  
 
39 For previous stateme nts follow the thread under ID 534. G/TBT/M/83  
 
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  2.161.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding the China's "Encryption Law " that entered into force on 1 January 2020 and 
would  like to refer to the previous statement we made at the last TBT Committee in October 2020. 
Japan would like to request that China's regulation not hamper foreign companies' activities or 
market access to China.  
2.162.   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 organi zations equally including foreign -invested enterprises that engage in 
commercial cryptography research, production, sales, service, importation and exportation, etc. 
China encourages technical cooperation in commercial cryptography based on voluntary princ iple 
and commercial rules in the process of foreign investment. Administrative agencies and their staff 
are prohibited to force any transfer of commercial cryptography technology by means of 
administrative measures.  
2.1.3.15   China - Cosmetics Supervision and Admini stration 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 , G/TBT/N/CHN/1515  (ID 57640) 
2.163.   The representative of the United States  provided the following statement. The United States 
recognizes that although China's Cosmetics Supervision Administration Regulation (CSAR) entered 
into force in January, its im plementing measures are not yet finalized. We ask that China work with 
the United States and other WTO Members to address outstanding concerns before these 
implementing measures are finalized, so as to provide certainty to the industry and US companies 
in future trade with China. The United States emphasizes that it is inappropriate to apply a similar 
regulatory approach to cosmetics as is applied to medical devices or drugs because cosmetics are 
considered low -risk products. This has resulted in an overly burdensome application process that 
does not provide adequate protections for the intellectual property of cosmetics rightsholders and 
mandates animal testing, even when alternatives exist. As we noted in an earlier intervention on the 
newest implementing measures of the CSAR, the United States notes the new language on 
intellectual property (IP) protections in Article 55 of the Administrative Measures (1454), stating 
that the National Medical Products Administration (NMPA) shall not, with some exceptions, disclose 
confidential business information (CBI) or trade secrets submitted by a registration applicant or a 
notification applicant. We ask that China please confirm that this provision also applies to information 
submitted by local agents in accordance wi th Article  8. Has China offered or developed specific 
standard operating procedures or explicit steps to ensure the protections for CBI that can be tracked 
and are legally enforceable within China? NMPA's requirement in Article 8 of the Administrative 
Measures that importers use local agents to file their application increases the risk of unauthorized 
disclosures. NMPA should re -consider whether its extensive disclosure requirements are necessary.  
2.164.   We thank China for its response to US comments on G/TBT/N/CHN/1453  and 
G/TBT/N/CHN/1454  and ask that China c onsider the comments we sent back. We, as well as other 
WTO Members, continue to urge that China does not require cosmetics rightsholders to publicly 
disclose the proprietary study designs, protocols, data and analysis used to verify their product 
claims. We are also concerned that China is requiring companies to provide animal testing to 
establish conformity for imported products that cannot provide a regulator -issued good 
manufacturing practices (GMP) certificate. Trade associations and other third partie s issue 
certificates of compliance with international cosmetics GMP standards, which are widely referenced 
by other WTO Members in their GMP requirements, and which do not require animal testing. If China 
will not accept these certificates, we ask that Chi na explain why these international standards are 
inappropriate for the fulfilment of China's regulatory goals. NMPA should consider how its 
requirements in the Classification Rules and Catalogue of Cosmetics (1460) may impact innovations 
in new products an d ingredients, if NMPA limits the means by which companies can verify their 
claims. Companies should be provided flexibility in claims verification and the use of international 
labs that follow Good Clinical or Good Laboratory Practices, so long as they ca n provide, as needed, 
the verification information requested by Chinese regulatory authorities. Further in China's draft 
Administrative Measures on Cosmetics Labeling (1515), the United States is concerned that the 
proposed regulation regarding foreign lan guage text and misleading use of trademarks or suggestive 
 
40 For previous statements follow the thread under ID 576. G/TBT/M/83  
 
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  words, graphics or symbols, is overly burdensome. We appreciate China's most recent notifications 
of CSAR implementing measures and request that China continue to notify all CSAR implementing 
measur es and standards with a minimum of 60 days for comment, and that China take these 
comments into account before final versions are adopted.  
2.165.   The representative of Australia  provided the following statement. Over several years 
Australia has raised concerns ab out China's measures requiring mandatory testing on animals before 
registering imported cosmetics for sale in China. This measure discriminates in favour of Chinese 
products which are not required to undertake mandatory animal testing. It is also more trad e 
restrictive than necessary given that general cosmetics are low -risk products, and that there are 
other internationally recognised methods of ensuring that skincare products are safe. The animal 
testing measure has had a major impact on Australian cosmet ics exporters, effectively preventing 
them from entering and competing in the Chinese market. We had hoped that the CSAR and its 
related implementing regulations would result in the complete removal of China's animal testing 
measure and replace it with les s trade -restrictive appropriate measures. However, exporters are still 
concerned that China's new cosmetics regulations will result in further trade barriers. It appears that 
the animal testing requirement for imported general cosmetics will be effectively  retained for those 
countries where Good Manufacturing Practice (GMP) is not certified by the cosmetics regulator of 
the exporting country. It also appears that mandatory animal testing will continue to be a 
requirement for all cosmetics classified by Chin a as special use.  
2.166.   Because many countries (including Australia) consider general use cosmetics to be low -risk 
products, they do not require GMP certification of these products. Could China please explain why it 
would require GMP certification for low -risk skincare and cosmet ics products? Further, assuming that 
GMP certification is required in the final regulations, could China please advise why it would need 
this certification to be provided by a government regulator, rather than an industry organisation or 
private provider t hat could certify in accordance with international practices and standards? Australia 
would also like to understand why China considers animal testing and GMP certification to provide 
equivalent levels of safety assurance for Chinese consumers. Australia u nderstands that China 
intended for the CSAR to enter into force on 21 January 2021. Could China please advise whether 
there have been any issues with implementing the CSAR given that many of the implementing 
regulations are still in draft form? Australia w ould also welcome any details from China on when it 
expects to revise and finalise these draft regulations and whether it intends to release any further 
draft cosmetics regulations. The Australian Government has previously submitted written comments 
on Chi na's Cosmetics Supervision and Administration Regulation (CSAR) and its various 
implementing regulations. We would welcome a response from China on how these comments have 
been taken into account by the Chinese Government and an opportunity to discuss the comments 
bilaterally.  
2.167.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to support the delegation of the United States. With regard to the notifications 
G/TBT/N/CHN/1310  and G/TBT/CHN/1331 , Korea has found t hat many provisions in the regulations 
include same obstacles to trade which were already indicated in other cosmetics regulations of China. 
Korea wishes to reiterate concerns as follows. Two among the following concerns are the same as 
what we raised in STC 1.41 First, Korea requests China that the labelling of cosmetic ingredients be 
consistent with international practices. Second, under the Regulations, China requires the disclosure 
of the summary of scientific evidence that supports cosmetic efficacy cl aims on the websites 
designated by the NMPA. However, the information China claims to be minimal may contain a 
number of trade secrets or undisclosed business information that are critical to our industry. Korea 
therefore urges China to remove the provisio ns requiring the disclosure of information. Third, Korea 
would like to request China to accept the test results by laboratories outside China that comply with 
Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) in applying for cosmetic registrat ion 
in China. Fourth, given that the licence issued by most of the countries including Korea, the U.S., 
and European states do not have a determined validity period, Korea requests China to provide the 
rationale or justification for setting the validity pe riods of the license for special use cosmetics. Korea 
would like to kindly ask China to notify all of its next steps in the development of the Regulations 
and to provide time frames for the publication of the final Regulations and their entry into force. W e 
also call on China to grant a reasonable transitional period for the industry to prepare to comply with 
 
41 China - CSAR - Draft Specifications for Cosmetic Registration and Filings; Draft Specifications for 
Registration and Filing of New Cosmetics Ingredients; Draft Specifications for Cosmetic Efficacy Claim 
Evaluation, Provisions for the Supervision and Administration of Toothpaste  (ID 665 ). G/TBT/M/83  
 
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  the new requirements according to Article 2.12 of the TBT Agreement. Considering the 
aforementioned concerns, Korea would like to refer to our previou s comments submitted to China's 
Enquiry Point for TBT. Korea calls on China to consider the comments from Korea and other Members 
into revision, and to notify the finalization of the revision to the TBT Committee.  
2.168.   The representative of Japan  provided the f ollowing statement. With respect to "Cosmetics 
Supervision and Administration Regulation " and its implementing regulations, Japan continues to 
express the following concerns. The "Cosmetics Supervision and Administration Regulation " provides 
that the regis tration or filling information on cosmetic products or new ingredients shall be published. 
The regulation also provides that the abstract of scientific basis of efficacy claims shall be published 
online and accept social supervision.  Therefore, in the cont ext of protection of intellectual property, 
Japan requests that confidential corporate information specified by registrants or filers not be 
disclosed to the public. Japan appreciates China's reflection that article 55 of "Provisions for 
Cosmetics Registra tion", which was promulgated on 7 January 2021, provides that confidential 
information for companies or unpublished information must not be published. Japan would like to 
request that "Cosmetics Supervision and Administration Regulation " and its other impl ementing 
regulations provide the same rule. In addition, in case that disclosure of such specified confidential 
information is exceptionally necessary, registrants or filers should be given the opportunity to consult 
with the NMPA in advance. Furthermore, Japan would like to request that China clarify that the 
abstract of scientific basis of efficacy claims should be disclosed by the time of launch of products in 
the market.  
2.169.   "Management Rules for Testing required for Cosmetic Product Registration and Notifi cation ", 
which was promulgated on 12 September 2019, provides that microbiological, physical and chemical 
tests, toxicological tests and human safety and efficacy evaluation tests relevant to cosmetics 
registration and filing shall be conducted by the test ing laboratories in China that obtained China 
Inspection Body and Laboratory Mandatory Approval (CMA). Japan would like to request a more 
flexible framework in which test results obtained by foreign laboratories with the equivalent 
qualifications and abili ties as those of Chinese testing laboratories are accepted. In addition, 
regarding test methods, the implementing regulations of the "Cosmetics Supervision and 
Administration Regulation " provides that test methods including test items other than those stat ed 
above, should be conducted in accordance with China's national standard or relevant regulations, 
and that various restrictions and conditions are imposed in the case of conducting a test method 
which is not specified in the regulations. Japan would like  to request that China accept internationally 
accepted methods such as alternative test methods established by the OECD, or the ISO. 
Furthermore, China has not finalized detailed information regarding test methods required for 
whitening products. Since whi tening 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. The sales certification that proves the products have been sold on the market in the 
country of production is only imposed on imported cosmetics. Japan requests that China treat 
imported products no less favourable than products produced in China.  
2.170.   In addition, regarding China's draft of the "Administrative Measures on Cosmetic Labe ling", 
Japan appreciates that China provided the opportunity to give comments to WTO/TBT notification. 
As Japan has noted in the comment to WTO/TBT notification, Japan would like to express its following 
four concerns. Article 5 provides that the content o f 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 th eir contents do not always comply with China's regulations. Therefore, Japan would like to 
request that China assure that such requirement does not apply to labelling contents required by 
regulations in the country of production, and that the requirement w ill not be more trade restrictive 
than necessary to fulfil legitimate objectives. Regarding Article 6. In order to avoid confusion among 
consumers, Japan would like to ask China that the label indicates a single responsible person 
("cosmetics registrants o r filers " or in the case of imported products, "responsible person in China"), 
and Japan considers that the label requirements regarding producers are not necessary. With respect 
to the rules for labelling of all ingredients in cosmetics, there is an inter nationally recognized listing 
practice that ingredients with a compounding amount of 1% or less are allowed to be listed in no 
particular order. However, Article 12 provides that only ingredients with a compounding amount of 
0.1% or less are allowed to be listed in no particular order. Japan would like to request that China 
assure that the rules for labelling follow the internationally recognized practice so as not to be more 
trade restrictive than necessary.  G/TBT/M/83  
 
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  2.171.   Article 19 provides that the indications as "eva luated and verified efficacy" could be put on 
products only if the efficacy is confirmed by the qualified testing laboratory in China. However, 
"Specifications for Cosmetic Efficacy Claim Evaluation (Draft for Comments) ", which was notified to 
the TBT Comm ittee on 18 November 2020, provides that all efficacy should be confirmed by 
appropriate test methods. Japan would like to make a request that permits the indication of 
"evaluated and verified efficacy" on the efficacy that is confirmed by appropriate test  methods 
according to the "Specifications for Cosmetic Efficacy Claim Evaluation (Draft for Comments) ", not 
limited to the one confirmed by the qualified testing laboratory in China. Furthermore, "Provisions 
for Cosmetics Registration ", which was promulgat ed on 7 January 2021, Japan continues to express 
the following concerns. Japan would like to request that it is not necessary to cancel original 
registration or filing if changes are not related to product safety, for example if a change is only 
related to  a product's name. Moreover, the "Provisions for Cosmetics Registration" provides that 
overseas inspections are to be conducted in accordance with relevant regulation of overseas 
inspections. Regarding "Interim Measures on the Administration of Overseas In spections of 
Cosmetics ", Japan would like to continue to express concerns on the following three points.  
2.172.   Japan would like to request that China clarify which laws and regulations are used to 
determine conformity and specific purposes for conducting oversea s 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 subject of the inspection 
including the product research  and development stage is broader than necessary, and it causes 
unnecessary burdens for companies. The main purpose of the inspection seems to ensure product 
safety but information related to research and development is not necessarily essential for produc t 
safety assurance. It is the most confidential corporate information. Therefore, R&D departments of 
companies should be excluded from the subject of overseas inspections. Furthermore, inspections 
for domestic Chinese companies are only conducted on produc tion sites. Japan would like to request 
that China provides equal treatment to both domestic and overseas companies. Japan requests that 
China ensures that confidential information will not be disclosed to anyone other than those who are 
necessary for the legitimate purpose of the inspection, since production sites also contain a lot of 
confidential corporate information. Finally, as the "Cosmetics Supervision and Administration 
Regulation " and its implementing regulations will cause great change, reasonabl e transition time is 
necessary to ensure business continuity. Japan would like to request that China provides 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 request that products that have already been registered and filed based on current regulations 
are not subject to measures under the new regulations.  
2.173.   The representative of New Zealand  provided th e following statement. New Zealand again 
welcomes China's undertaking to modernise its regulatory system for cosmetics and again welcomes 
the opportunity to provide further comments on China's proposed measures. In addition to 
comments previously made unde r agenda item 1 at this Committee and also during the October 
2020 TBT Committee, New Zealand also holds concerns, that we understand are shared by a number 
of Members, around the issue of having more detailed disclosure of formulas than is required in 
other markets, including specific sources of each ingredient. New Zealand encourages China to limit 
disclosure requirements, particularly that of sensitive information, to that which is required to assure 
product safety in China's domestic market and so as no t to compromise intellectual property. New 
Zealand looks forward to engaging further with China on its proposed CSAR measures. This will 
enable New Zealand and other WTO Members to assess in greater detail the potential impact on 
trade of these measures.  
2.174.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Japan, Korea, the United States, Australia and New Zealand. The 
EU welcomes the new CSAR that has the potential to create an equal tre atment of domestic and 
imported non -special cosmetic products. It can move China significantly further towards a modern 
cosmetics legislation based on industry responsibility and safety assessment. Such higher 
international compatibility of Chinese cosmeti cs regulation will benefit Chinese consumers, the 
development progress of the Chinese cosmetics industry and multilateral trade in cosmetics. To fully 
achieve the objective of equivalent 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 cosmetics. The proposed draft Regulation for Notification  of Non -
special Cosmetics ( G/TBT/N/CHN/1331 ) enables importing companies to confirm completely the G/TBT/M/83  
 
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  safety of the product based on safety assessment, granting an exemption from toxicological tests 
carried out on animals. This exemption is conditional to submission of a certificate of the production 
quality ma nagement system by a regulatory body. The EU understands and welcomes that this aims 
at creating an equivalent requirement to the pre -market manufacturing licensing requirements 
applicable to domestic manufacturers. However, in many countries or regions, i ncluding the EU, the 
administrative management of cosmetics manufacturing is not based on a pre -market licensing 
approach but on in -market control. Therefore, in most EU member States, the respective authorities 
may not have a legal basis for issuing such certificates.  
2.175.   In most countries, including the EU, companies manufacturing cosmetic products are obliged 
to follow Good Manufacturing Practices (GMP) and attest this in the mandatory product 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 opinion that in principle, company -issued GMP certificates from 
manufactu ring 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 with regard to the type of 
document and the organisation issuing it su ch as manufacturing licence, Quality management / GMP 
certificate or inspection/audit conclusions. Such documents can be issued by state regulatory 
authorities, local authorities (e.g. provincial or municipal) or industry associations recognized by 
authori ties 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 appreci ate 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.  
2.176.   In response, the representative of China  provided the following statement. We would like to 
clarify the following points. Regarding the protection of trade secrets in the registration and filing 
materials. As cosmetics are health -related products, materials such as product formula, and 
production process of cosmetics are an important basis for produ ct 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 the information containing commercial secrets, personal privacy or other elements 
which may cause 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 for the issue of alternatives to a nimal testing, the 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 requested 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 imported 
and d omestic ordinary products are required to hold production licences or documents of good 
manufacturing practice issued by government supervision departments.  
2.1.3.16   European Union - Transitional periods for MRLs and international consultations 
(ID 58042) 
2.177.   The repre sentative of Costa Rica  provided the following statement. As in previous meetings, 
Costa Rica associates itself with the concern raised by the United States, Colombia,  Indonesia, Brazil 
and Guatemala, 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.  It is impossible for agricultural production in 
Costa Rica to adjust to  new requirements or tolerances within six months, when the registration of 
new molecules alone must undergo a complex assessment process lasting much longer than that 
period. This relates to the European Union's process to revise the tolerances for differ ent substances 
used in agricultural production.  In the current historical context in which the international community 
 
42 For previous statements follow the thread under ID 580. G/TBT/M/83  
 
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  finds itself due to the 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 for ce of reductions of maximum residue 
levels (MRLs) for plant protection products in light of the COVID -19 pandemic.  
2.178.   The representative of the United States  provided the following statement. We continue to 
raise our concern about the European Union's (EU) tr ansition measures and request adequate time 
for US and third -country producers to modify their pest management programmes to move their 
products through the channels of trade, including shelf stable products with years long shelf lives. 
We recall longstand ing concerns that trading partners do not know with certainty the impact of non -
renewal decisions on future MRLs even when they are published as both TBT and SPS notifications. 
Applications for import tolerances remain active and the review of additional d ata are often 
considered after a non -renewal notice has been issued. Foreign growers cannot make informed 
decisions on their food production practices until the MRL is notified and then typically only a six -
month compliance period is extended. Trading part ners have found themselves racing to move 
shipments through customs fast enough to prevent rejections or turning back orders because a 
product that complies with an existing EU MRL standard at the time of production will face rejection 
at EU borders. EU gr owers do not face these restrictive timelines under the current regulatory 
provisions. Once again, the United States reiterates our request that the EU retain existing MRL 
levels while Import Tolerances are under consideration, conduct full risk assessment s prior to setting 
new MRLs, and extend its MRL transitional measures to account for realistic production and 
processing times for food and agricultural products. The United States requests imported products' 
MRLs to be considered on the EU market at the t ime of production, the same as for European 
products.  
2.179.   The representative of Colombia  provided the following statement. Colombia reiterate s its 
grave concern regarding international consultation processes adopted and the transition periods 
granted by the E uropean 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 producing 
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 producer s related to short 
transition periods for the entry into force of standards that do not allow for the marketing of certain 
plant protection products and the subsequent reduction of MRLs is a matter of concern. These 
measures create additional burdens for a gricultural 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 t ransition periods can create situations in which 
imported products are discriminated against in favour of domestic products, as goods produced in 
accordance with the EU standards in force at the time of production may no longer be eligible to 
enter the EU by the future date on which they arrive at the border.  Moreover, the situation arising 
from the COVID -19 global health emergency has forced the health and scientific authorities of all 
countries, including Colombia, to focus attention on that crisis.  In line with the statements made in 
communication G/TBT/GEN/296/Rev.3 , 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.  
2.180.   Furthermore, Colombia maintains that notification to the WTO of non-renewal or on MRLs to 
be applied, and of transition periods, should not be made  by the EU as a simple formality within the 
regulatory process. As provided in Articles 2.9.2  and 2.9.4, the notification must be submitted within 
a time limit that allows Me mbers concerned  to submit substantive observations and comments for 
genuine consideration by whoever is developing the technical regulation, in this case the Committee. 
Within  the framework of this Committee, it cannot be acceptable for the European  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 informatio n must first be notified to the 
WTO and the public consultation period held. Nor is it acceptable for the EU to publish the final 
regulation the day immediately after the end of the international consultation period, as this shows G/TBT/M/83  
 
- 47 - 
 
  that the comments submitt ed have not been taken into account. We invite the EU to follow the 
recommendations of good regulatory practices, under which standards must be based on clear and 
objective information and on the promotion of open dialogue with stakeholders, transparency a nd 
the minimizing of market distortions. In accordance with the provisions of Articles  2.5 and 2.12 of 
the TBT Agreement , Colombia considers that there should be technical discussions, which take into 
consideration the arguments and technical, scientific a nd economic evidence submitted by the 
Members concerned, in order to review the time limits  for bringing into force the regulatory changes 
to MRLs,  so as to prevent them from becoming unnecessary barriers to trade.  Colombia once again 
welcomes the opportun ity to express its concerns on this issue and looks forward to a response from 
the European Union.  
2.181.   The representative of Brazil  provided the following statement. Brazil supports the concerns 
raised by the US, Colombia and Costa Rica, and we would like to r efer to its 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 reg ulations and their entry into force, except in cases of urgent problems of 
safety, health, environmental protection or national security. It is of utmost importance that the EU 
provides adequate transitional periods, especially for those cases in which the  scientific opinions of 
the EFSA on the toxicity of substances are "inconclusive" or only indicate a "suspected risk". 
Transitional periods should also be compatible with the production processes, so as to allow 
producers – and especially small farmers – to adapt to the new regulations.  
2.182.   The representative of Canada  provided the following statement. Canada would like to 
reiterate its concern with the EU's transition periods for maximum residue limits. Currently, transition 
periods do not apply to third count ries, 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. Cana da seeks 
confirmation from the EU that transition periods will provide sufficient time for producers and 
exporters to adapt to the new requirements and allow for trade to continue uninterrupted, where 
the risks of dietary exposure are acceptable. In our vi ew, the sudden deletion of MRLs and import 
tolerances is disproportionate to the level of risk and more trade -restrictive than necessary. At a 
time when ensuring food security is paramount, we urge the EU to consider transition periods for 
MRLs, taking int o account the need for exporters to adapt to new requirements, as it has done for 
its domestic producers.  
2.183.   The representative of Guatemala  provided the following statement. Guatemala reiterates its 
concern about the matter of endocrine disruptors and the ha zard-based approach . The importance 
of the general risk analysis framework needs to be recognized ( this includes  risk assessment, risk 
management and risk communication).  The precautionary principle is justified when potentially 
negative effects are identi fied, available scientific data is assessed and there is growing scientific 
uncertainty.  We would like to reiterate the importance of using risk analysis for import tolerances, 
particularly for tropical developing countries, where climatic conditions differ from those in the 
European  Union, in that we do not have a harsh winter to help control pests.  Geographical location, 
namely, the distance and time needed to export a product to the European  Union, is another factor 
that should be taken i nto consideration to avoid applying measures that unnecessarily restrict trade.  
2.184.   The representative of Paraguay  provided the following statement. Paraguay wishes to 
reiterate its deep concern regarding this measure and refers to its statements made at previ ous 
meetings. 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 due  to a lack of conclusive scientific evidence, 
even in cases where the Codex Alimentarius has identified certain substances as being safe. There 
is a need to consider the importance of adopting a science - and risk -based approach for regulating 
plant protect ion products rather than considering only the potential for harm (hazard) due to the 
intrinsic properties of a chemical. The European approach to limit the use of pesticides is more trade -
restrictive than necessary to fulfil its legitimate objectives under  the TBT Agreement.  We stress that 
the pursuance of such policies will cause significant trade damage to the economies of developing 
countries and jeopardize their ability to achieve  the Sustainable Development Goals, including those 
related to food securi ty. 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 necessar y, provide 
adequate transitional periods.  G/TBT/M/83  
 
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  2.185.   The representative of El Salvador  provided the following statement. El Salvador thanks the 
delegations of Costa Rica, the United States of America and Colombia for bringing this concern to 
the attention of Committe e members once again. 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 res ult in 
unjustified restrictions on trade.  
2.186.   The representative of Chile provided the following statement. As in previous committees, 
and like other delegations that have taken the floor before me, Chile wishes to echo the trade 
concern raised concerning the implementation of maximum residue levels set for various agricultural 
products by the European Union, as well as their implementation periods and periods of validity. We 
will continue to monitor developments in this committee and other relevant committees.  
2.187.   The representative of Panama  provided the following statement. The delegation of Panama 
echoes the comments made by all the delegations that spoke before me on the new maximum 
residue limit tolerances established by the European Union. These concerns have  already been 
discussed at length, so, in the spirit of brevity, we reiterate the statements that we made in the past 
in this regard.  
2.188.   The representative of Ecuador  provided the following statement. Ecuador thanks Colombia, 
Costa Rica and the United States for including this item on the agenda and we echo our previous 
statements on this specific trade concern.  In order to establish reasonable transition periods, several 
factors must be taken into account, such as harvest times and when agrochemicals are appl ied. The 
transition periods granted by the EU fail to provide sufficient time for producers to adapt so as to 
prevent their access to the European market from being unnecessarily affected.  It is important to 
note that the impact of the non -renewal decision  on future MRLs is unknown, and foreign producers 
cannot make informed decisions about their food production practices in the present.  Once again, 
Ecuador urges the EU to provide a period of at least 36 months, which is the time needed to develop 
a new phy tosanitary pest control product.  Ecuador is aware that the EU allows its farmers to request 
emergency authorizations so that, in certain particular situations, they can use active substances 
that have already been banned in the European market. For Ecuador , it is important to know whether 
these authorizations could be used by third countries (outside the EU) when the amended MRLs 
enter into force.  Ecuadorian farmers are, even against the backdrop of COVID -19, making every 
effort to comply with the EU's requ irements. 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 lai d 
down in European Union regulations.  
2.189.   The representative of Uruguay  provided the following statement. Uruguay wishes to thank 
the United  States  of America, Colombia and Costa Rica for including this item on the Committee's 
agenda.  In view of harvesting per iods, the stages at which plant protection products are applied, 
and the time required to develop and register alternative substances, in practice, the transitional 
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 and ensure that 
agricultural products, especially processed or frozen products, comply with the new, lower MRLs.  
Like other Members, Uruguay does not consider six months to be a su fficient period in this regard.  
My delegation reiterates its call on Members to  adopt regulatory decisions based on internationally 
accepted standards or to provide conclusive scientific evidence when it is strictly necessary to depart 
from these standards  in order to meet their 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 need to grant transitional periods 
that are suffic iently long to make the relevant adjustments . 
2.190.   In response, the representative of the European Union  provided the following statement. At 
the TBT Committee meeting in May 2020, the EU provided detailed information on transitional 
periods for Maximum Residue  Levels (MRLs). As clarified in previous Committees, the EU considers 
that concerns on the setting of Maximum Residue Levels (MRLs) for pesticides – and any details 
regarding their implementation – to 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 notifies draft measures 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 G/TBT/M/83  
 
- 49 - 
 
  restriction of approval of an active substance will be notified to both Committees. However, in the 
interest of efficient proceedings in both Committees and in line with the respective Agreements, 
matters on approv als of active substances should be discussed exclusively in the TBT Committee, 
while matters on the setting of MRLs for pesticides should be discussed exclusively in the SPS 
Committee.  
2.1.3.17   European Union - Medical Device Regulation (MDR) and In Vitro Diagnostic 
Medical Devices Regulation (IVDR), G/TBT/N/EU/71/Add.1 , G/TBT/N/EU/72 , 
G/TBT/N/EU/72/Add.1  (ID 59443) 
2.191.   The representative of the United States  provided the following statement. 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 i ssues remain regarding implementation of both the MDR and IVDR, and US 
industry remains concerned about its continued access to the EU's US$125 billion medical device 
market, US$20 billion of which is supplied by US products. The 11 January 2021 Commission  Notice 
permitting remote audits by Notified Bodies (NBs) is a welcome development. In acknowledging the 
significant obstacles travel restrictions and quarantine orders pose to on -site audits during the 
pandemic, this temporary allowance may help facilitat e safe and timely product approval. We are 
eager to see how remote audits proceed in practice to alleviate the assessment backlog and 
ultimately ensure patients' continued access to much needed medical devices and in vitro  diagnostic 
tools. While we are en couraged that 18 NBs have been approved to assess conformity to the MDR 
as of January 2021, the rate of new approvals is slow. For example, only one NB has been added 
since our last meeting in October. Does the EU have a sense of how Notified Body applicat ions are 
moving through the review process and whether adequate capacity will be in place for manufacturers 
to meet the May 2021 implementation date? We note that as of January 2021 there are only four 
NBs approved to assess conformity to the IVDR. In view  of this lack of testing capacity, we again 
recommend serious consideration also be given to a significant extension of the implementation date 
for the IVDR. By extending the implementation date to May 2023, the EU may help alleviate concerns 
regarding ins ufficient testing capacity.  
2.192.   We are also concerned about the status of standards that companies can use to demonstrate 
compliance with the general safety and performance requirements. When will the new 
standardization request be released, and will the reque st be based upon the latest international 
standards? In addition, we understand that the Commission intends to create harmonized European 
standards to demonstrate compliance with EU legislation rather than use existing international 
standards. We urge the Commission to use internationally recognized standards where possible to 
avoid duplicative efforts and additional burden on manufacturers to comply with separate 
harmonized standards - one for the EU and others for other international regulatory authoritie s. 
Further, we understand that standards would not be in place until earliest 2024, three years after 
the MDR goes into effect, even with the one -year delay. What is the EU doing to address this? We 
note that in preparation for the implementation of MDR, t he Commission issued a guidance in 
January 2020, announcing it selected the Classificazione nazionale e internazionali (CND), a Unique 
Device Identifier (UDI) system that is not harmonized with the well -established UDI system that 
utilizes the Global Medic al Device Nomenclature (GMDN).44 GMDN was developed with the support 
of ISO and the International Medical Device Regulators Forum, and is widely adopted by the medical 
device industry and is used by over 70 national medical device regulators to support the ir activity. 
We are concerned that EU's selection of CND will undermine the interoperability of the two UDI 
systems for tracking and reporting purposes, and will pose several significant 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 that it will encourage other regulators and 
entities, like the World Health Organization, to adopt CND, creating duplicative requirements for the 
medical device industry, and thus ultimately harming public safety.  
 
43 For previous statements follow the thread under ID 594. 
44 The European Commission announced its decision to adopt CND via guidance: 
https://ec.europa.eu/health/sites/health/files/md_topics -
interest/docs/md_emdn_eudamed_nomenclature_en.pdf   G/TBT/M/83  
 
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  2.193.   The representative of Japan  provided the following statement. We request that MDGC 
guidance be issued in accordance wi th the ongoing guidance development and other relevant work 
within MDCG Subgroups. Since the date of application of MDR is approaching, we request a 
clarification of the issue date of the MDCGs and other guidance in the "Post Market Surveillance 
Requiremen t" and that proper transition periods are to be set in the guidance. The harmonized 
standard for MDR has not been published yet. We request that it be published as soon as possible 
and that proper transition periods are to be set along with the publication  of standards. We welcome 
the fact that the review of MDR by NBs had already started in Japan, and the number of cases where 
on-site audits have been completed has been increasing. On the other hand, in the MDR, strict 
clinical evaluation is required for C lass I, IIa and IIb medical devices. We are concerned that since 
the end of last year, there has been an increasing number of cases where the review of clinical 
evaluation, one of the required technical documents, has not been completed. In order to preven t 
the MDR from becoming more trade -restrictive than necessary, we request that the MDR be applied 
in the same way as other countries' regulations on medical devices with the same level of risk, such 
as exempting or simplifying the clinical evaluation requi rement for medical devices that can be shown 
to be equivalent to medical devices that are already on the market with a CE mark (equivalent 
medical devices) based on Directive 93/42/EEC. The workload of NBs is still focused on the MDR 
because the expiration  date of the transition period for the MDR has been postponed. We request 
an extension of the transition period for the IVDR until May 2023. We also request the prompt 
issuance of guidance documents for the IVDR and that the timeline for their issuance be provided 
as soon as possible.  
2.194.   The representative 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 notified bodies 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 Europea n Medical Device Nomenclature System under the new EU MDR 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 s ystem 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?  
2.195.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to support the delegations of the United States, Japan and Canada. Given that the new 
Regulation  emphasizes the importance of patient safety, traceability  and transparency, it will have 
a great impact on our manufacturers. Therefore, it is in our interest to better understand and prepare 
for the potential impact the Regulations will have on our industry. We hope that the MDR and IVDR 
will successfully enter  into force, as expected for May 2021 and May 2022 respectively, and that the 
EU will provide comprehensive regulatory information including MDCG guidance to help the industry 
well prepare for the upcoming entry into force. We expect that EU's efforts will  lead to a smooth 
transition from the Directives to the Regulations.  
2.196.   The representative of China  provided the following statement. China would like to thank US 
and Japan for raising this STC. China would also like to thank EU for the replies to our previou s 
concerns on in vitro diagnostic medical devices. However, we still remain concerned about the 
Medical Device Regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR). For MDR, 
China suggests that EU level guidance for the requirements o f CE technical documentation with 
uniform requirements, standards for auditing and conformity assessment of NBs, and specific 
product guidance should be established as applicable. The long -term planning and annual planning 
of the guidance should be prepare d. The reasons are as follows: (i) lack of unified requirements or 
guidance leads to significant differences in auditing standards among NBs; and (ii) lack of guidance 
documents related to specific products, which leads to the differences in the audit of g eneral safety 
and effectiveness among different NB when they audit the same products. The establishment of the 
guidance document, especial for the technical documentation guidance, is a process of continuous 
improvement. Therefore, the formation of long -term planning and annual planning of the guidance 
document can be important to support the continuous improvement and unification.  
2.197.   Postpone the transition deadline of high -risk devices for class III and class IIB devices by 
one year, the reasons are as follo wing. In the MDR regulation, the evaluation and audit of devices 
of class III and class IIB rely heavily on local European experts, especially the audit of clinical data G/TBT/M/83  
 
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  and CER (Clinical Evaluation Report), which requires the intervention of the medical d evice expert 
group. In particular, the examination on high -risk products of class III are basically dependent on 
the European local experts. However, due to the spread of COVID -19 epidemic, it is difficult for 
European experts to conduct on -site audits in third countries, besides, the current arrangement for 
remote auditing cannot ensure timely certification and effective audition. China suggests postponing 
the listing of high -risk class III and IIb devices for one more year.  
2.198.   For IVDR, postpone the transiti on deadline of IVDD and IVDR for 2 years. Manufacturers are 
facing a huge amount of certification work before the implementation of the IVDR. However, at 
present, the EU has announced only 4 Notified Bodies and has neither issued nor updated the list of 
EU harmonized standards nor the more detailed certification guidelines, and no laboratory has been 
authorized by the EU as a reference laboratory yet. Importantly, considering the pressure on national 
authorities of EU member States, Notified Bodies, manufac turers, and other actors and the impact 
of COVID -19 epidemic, it would be difficult for manufacturers to rectify conduct tests in authorized 
laboratories and obtain certificates issued by the notified body in a timely manner. Manufacturers 
are unable to co mplete a conversion review of all the products before the implementation of IVDR. 
Therefore, China requests that EU postpones the transition deadline of IVDD and IVDR from May 
2022 to May 2024. Expedite the announcement of laboratory authorization and prep aration: 
manufacturers need to consider the allocation of laboratory resources in advance while applying for 
product certification. As EU has not announced any laboratories, and certification of high -risk 
products takes a relatively long time, manufacturer s cannot choose the suitable laboratory 
configuration and optimize them, which will increase the difficulty of certification.  
2.199.   The representative of Singapore  provided the following statement. Singapore appreciates 
the European Commission's one -year delay i n the implementation of the MDR until 26 May 2021, 
which has allowed for relevant stakeholders to prioritise the ongoing COVID -19 pandemic. We also 
acknowledge the EU's continued efforts in the designation of Notified Bodies (NBs) under the MDR 
and IVDR. H owever, we support the concerns raised by other Members, and remain concerned that 
there is still an insufficient number of designated NBs under the MDR, despite its looming 
implementation date. We note that to date, only 19 NBs have been designated under the MDR, which 
is significantly lesser than the number of designated NBs under the MDR. This has led to concerns 
over bottlenecks in the certification of medical devices, and the resultant risk towards continued 
access to the EU's medical device market. We  seek the EU's consideration of this issue, and look 
forward to further developments to facilitate the smooth transition to the MDR.  
2.200.   In response, the representative of the European Union  provided the following statement. As 
regards the date of application  of the MDR, on April 2020, and due to the exceptional COVID -19 
circumstances, and with patient health and safety as a guiding principle, a postponement of the date 
application, until 26 May 2021, was agreed upon by the EU co -legislators. The IVDR's corres ponding 
date of application remains the same (26 May 2022). The Commission continues to monitor the 
impact of the COVID -19 crisis and is working closely with competent authorities, notified bodies and 
industry to continuously assess the situation. The Comm ission is not currently considering a 
postponement of the MDR or the IVDR. The postponement which took place in April of last year was 
exceptional in its nature and essential to ensure continued patient care by allowing the significant 
scaling up of medica l device production in the EU. Currently, we are not aware of such needs as the 
availability of COVID -19 critical medical devices seems to have stabilized in the EU. Additionally, the 
different activated crisis mechanisms have now allowed the EU to form st ockpiles should such a need 
arise again. Furthermore, and pursuant to a January 2021 Commission notice on audits and 
surveillance assessments under the MDR and IVDR, the text provides for some more flexibility to 
member States to allow remote audits carrie d out by Notified Bodies, if the conditions set out within 
the notice are met.  
2.201.   As regards implementation work, the Commission and member States are continuing work 
on implementing acts and guidelines. To date, there have been above 60 published guidance 
documents, including several key guidance on clinical requirements. In addition, the expert panel 
representatives, who have a role in the conformity assessment procedures of certain high risk 
products have been announced and the registration module of the EU DAMED database was made 
available on December 2020. As reported in previous meetings, the other parts of the EUDAMED 
database will be made available in a gradual manner, with the Unique Device Identification module 
being released next. As regards Notified Bodies' availability, there have been 23 designations made 
thus far, 19 under the MDR and four under the IVDR. Of the Notified Bodies that also have a Medical 
Device Single Audit Program (MDSAP) designated auditing organization within their organization, 1 1 G/TBT/M/83  
 
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  out of 13 have so far been designated under the MDR. These organisations cover some of the EU's 
trade partners such Australia, Brazil, Canada, Japan and the US. It is important to underline that 
the EU does not expect to maintain the same number of Notif ied Bodies as currently existing under 
the Directives. Therefore, under the MDR/IVDR, the numbers will go down. Quantity is not and never 
has been an indication of capacity. As with anything related to demand and supply, the market will 
adjust and has in f act already done so as the 23 Notified Bodies already designated under the 
regulations reportedly hold more than a significant share of the market and have in addition 
considerably up -scaled their capacity. Finally, it is also important to remind that the grace 
mechanism, similar to but more stringent than the grandfathering concept, remains in order to 
smoothen the transition period. This means that the date of application is not a hard stop and that 
products certified today under the directives and prior to 26 May 2021 can remain on the market 
until at the latest 2025, if they respect the conditions set out in the Regulation. The EU is fully 
committed to ensuring that the new system provides a higher level of patient protection and counts 
on trade partners  to encourage their manufacturers to meet these new requirements to ensure trade 
continuity.  
2.1.3.18   China - Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61145) 
2.202.   The representative of the European Union  provided the following  statement. The EU is highly 
concerned about this measure as this will have a serious impact on importers into China. The EU 
shares China's concerns as regards food safety. Nevertheless, measures have to avoid unnecessary 
constraints. They should conform t o WTO agreements and Codex Alimentarius  guidelines.46 
Accordingly, registration, inspection and certification regimes applied to particular categories of 
products and processing methods must be in proportion to the associated risks. As presented, the 
measu re would put a substantial additional administrative burden on companies and competent 
authorities, including China Customs. The already long and time -consuming registration process will 
therefore be further extended. As regards the scope, the EU is seekin g clarification as to which 
facilities the registration obligations would apply. The EU understands that the notified measure is 
applicable to all types of foods and beverages. If this is the case, the EU underlines again its concern 
that pertinent adminis trative procedures must be practicable, retain the current well -established 
practices to the extent possible, and be accompanied by clear guidance and adequate transition 
measures. Otherwise there will be total chaos. More concretely, the EU strongly recom mends that 
the current, single entry point for registration47 be maintained and any duplication of data entry, 
through additional channels or unnecessary additional registration requirements, be avoided. 
Additionally, regarding the notified registration of  businesses on the basis of guarantees provided 
by the competent authority of the exporting country, whilst the EU supports these provisions in 
principle, we consider that the range of products covered by this registration regime is grossly 
disproportionat e and very unclear. As outlined in more detail in our written comments, many of the 
product categories listed in Article 6 of the notified measure are inherently safe, low -risk products 
that can be exported by China to the EU without authorization, prior i nspection or official guarantees 
in support of the listing of establishments. The EU strongly requests that China revises the scope of 
the measure in full consideration of Codex guidance and standards.  
2.203.   The representative of the United States  provided the f ollowing statement. The United States 
thanks China for notifying to the TBT Committee its draft "Administrative Measures for Registration 
of Overseas Producers of Imported Foods " (Administrative Measures). We remain concerned with 
this draft measure and urge China to carefully consider the finalization of such a restrictive regulation 
without a clear food safety and public health benefit. The proposed measure appears to affect all  
food products, regardless of risk or whether foods are already subject to additional import 
certification requirements. We anticipate that the draft measure, if implemented, would likely create 
a major trade disruption for every country that exports food and agricultural products to China, 
including for developing countries whose competent authorities may have limited capacity to meet 
China's proposed requirements. The United States urges China to consider taking a risk -based 
systems approach to determine what measures may be required for individual trading partners to 
meet China's appropriate level of consumer protection, focusing on particular high -risk foods. Could 
China please provide an update regarding its comment review process and timeline for next steps? 
This measure appears to overlap with other similar measures, notably Decree 177 on the 
 
45 For previous statements follow the thread und er ID 611. 
46 i.e. CAC/GL 20 -1995 on principles for food import and export inspection and certification.  
47 i.e. http://ire.custom s.gov.cn/ . G/TBT/M/83  
 
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  import/export of grain and the "Administrative Measures on Import and Export Food Safety " recently 
notified to the WTO SPS Committee as G/SPS/N/CHN/1191.  How does G/TBT/N/CHN/1522  relate to 
these other meas ures?  
2.204.   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 China for providing Members with the opp ortunity to comment on this 
proposed measure, which we have been following closely since February last year. As this proposed 
measure ( G/TBT/N/CHN/1522  on 16 November 2020) will be affecting a wide range of our food -
related industry, we are still consolidating the feedback from o ur manufacturers and will provide our 
written comments formally as soon as possible via the TBT Enquiry Point and bilateral channel for 
China's consideration. In addition to express our support to the concerns raised by other Members, 
we would like to high light the most important ones at this occasion. Firstly, to relieve regulatory 
authorities of other Members from the heavy burden of providing the statements mentioned in 
Subparagraph (4), Paragraph 2, Article 6 of the draft, we would like to request that the statements 
regarding compliance of the business operators with the requirements of the draft do not need to 
be provided if the food safety management system of exporting Members have already been 
assessed by China and confirmed to be equivalent to Chin a's regulatory system.  
2.205.   Secondly, the draft regulation covers a very broad scope of food products and we call for 
China to adopt a risk -based approach to align with international practices. In particular, we seek 
clarification from China of the following is sues. Please define the scope of "special dietary foods " and 
"health foods " mentioned in Paragraph 2, Article 6 of the draft. Are these products subject to 
approval or regulatory control before they can be labelled as special dietary food or health food an d 
placed on the market of China? If approval is required, are foreign manufacturers of such food that 
have been granted approval by the relevant authority still subject to this draft regulation of 
registration? Please provide the following clarifications: (i) the definition of each regulated food 
categories as mentioned in Paragraph 2, Article 6, and the foods that are not applicable as mentioned 
in Paragraph 2, Article 2; (ii) the definition of a change in risk as mentioned in Paragraph 4, Article 
6; (iii)  the frequency of the list of registered overseas business operators that will be published by 
the General Administration of Customs, as mentioned in Article 15; (iv) the given time period of 
rectification mentioned in Paragraph 1, Article 23, if the facil ity is no longer conformed to the 
registration requirements; and (v) the judgment principles for the revocation of registration 
mentioned in Article 24. Please clarify whether the correction reports mentioned in Paragraph 2, 
Article 23 are to be submitted by the registered business operators recommended by the competent 
authority or by the competent authority. We would be grateful if the above -mentioned comments 
could be taken into account. We look forward to continuing bilateral engagements with China on t his 
matter.  
2.206.   The representative of Brazil  provided the following statement. Brazil thanks China and 
appreciates the recent public consultation notified under Chinese notification 1522. In this new draft 
regulation, we value the further detailing of the scop e of the measure, the specification of product 
categories in the role of the exporting country competent authority, and the removal of punitive 
measures for importers who import product from unregistered food exporting facilities. We also take 
good note of  the withdrawal of requirements for annual verification by GACC and annual reporting 
by the exporting country's competent authority. We also thank China for notifying its new draft 
measure to the TBT Committee. However, we still believe said regulation mig ht complicate the 
registration and supervision of high -risk food products exported to China. If adopted, Brazilian food 
producers who intend to export to China might need to provide pre -export registration following 
stricter requirements. Based on the Chin ese statement in the last Committee meeting, China 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.  
2.207.   The new  draft could grant discriminatory treatment towards imported food products in 
relation to those produced in China, which are not subject to the rules of such registration process. 
These procedures are more trade -restrictive than necessary and they pose a g reat 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 prop erly address its legitimate concerns. The 
proposed measure also departs from a relevant international standard, notably the Codex CAC / GL 
38-2001 standard "Guidelines For Design, Production, Issuance, and Use of Generic Official 
Certificates ", by adopting  a different registration model that is more costly than that contained in G/TBT/M/83  
 
- 54 - 
 
  said standard. We also urge China to consider defining reasonable transitional periods for producers 
and exporters to adapt to the regulation. We would deeply appreciate it 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 technical basis for outsourcing inspection responsibility to the competent 
national authorities. Finally, could Chin a also commit to notify the TBT Committee of 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?  
2.208.   The representative of the Republic of  Korea  provided the following statement. Korea thanks 
China for providing the notification. Korea would like to support the delegations of the EU, the United 
States, Chinese Taipei, and Brazil. The COVID -19 pandemic has highlighted the importance of 
undisr upted supply of commodities. Against this backdrop, China's revised Measures  appear to place 
a larger strain on food supply chains as they require the registration of all imported food products. 
The revision would expand the scope of preliminary review and  registration recommendation by the 
exporting country's government, from the current animal products to agricultural foods, special 
dietary foods, dietary supplements and condiments. Such requirement would impose an enormous 
administrative burden and incur  excessive time and cost on both importing and exporting authorities 
responsible for food trade and could create an unnecessary barrier to trade. Korea would like to hear 
a detailed explanation from China on how it decided to include new food categories an d we request 
China to provide scientific evidence such as risk assessments that underpins the decision. 
Considering that only foods of animal origin are required in other countries, we urge China to 
maintain the current scope of food categories. According to the revised Measures , competent 
authorities for export are required to notify to the Chinese Government and suspend export if 
hazards associated with food safety are found in food products. Although Korea understands China's 
legitimate objective of prom oting food safety, such Measures would place an undue burden on 
exporting countries. Also, our industry is concerned with the current lack of clarity around the 
definition of "food safety hazards ". Korea therefore requests China to provide further clarity and 
details on the scope of application and requirements by the revised Measures. Korea also requests 
China to notify to the SPS Committee given that it is associated with sanitary and phytosanitary 
measures. As we are aware that Members had submitted comm ents to China by 15 January 2021, 
Korea requests China to take into account the received comments. Korea also calls on China to notify 
all of its next steps in the development of the Regulations  and to provide time frames for the 
publication of the final R egulations and their entry into force. Considering the possible entry into 
force, Korea would like to request that the exporters registered by the General Administration of 
Customs be permitted to retain their status without additional evaluation or regist ration processes. 
Korea also asks China to allow reasonable time for the industry to adapt to the new Regulation 
(G/TBT/N/CHN/1522 ) under Article 2.12 of the TBT Agreement.  
2.209.   The representative of Australia  provided the following statement. Australia welcomes China's 
notification o f the Regulation on Registration and Administration of Overseas Manufacturers of 
Imported Food ( G/TBT/N/CHN/1522 ). Australia provided comments on China's draft Administrative 
Measures for Registration of Overseas Producers of Imported Foods on 15 January 2021. Australia 
recognize s the right of governments to take measures necessary to protect public health, including 
food safety and hygiene measures. However, we are concerned that, as drafted, aspects of China's 
proposed Regulation are more trade restrictive than may be necessary to fulfil China's food safety 
objectives. In particular, we request China provide details of the risk analysis, scientific data and 
technical information used to develop this Regulation, and why the measures are not linked to the 
risks posed by the differe nt categories of imported food. Australia wishes to emphasise the 
importance of compliance with WTO obligations, including adopting or recognizing international 
standards to ensure any requirements implemented are no more trade restrictive than necessary. 
We are concerned that the proposed Regulation as drafted does not recognize equivalent national 
food safety systems based on Codex risk analysis principles, which meet the same objectives as 
Chinese food safety requirements and regulations.  
2.210.   For some foods,  aspects of the proposed measures do not appear to be linked to the risks 
posed by the category of imported food. As such, Australia believes the requirement for registration 
of all overseas food manufacturers, including those of highly processed food, wou ld place an 
unnecessary regulatory burden on the competent authorities. This increased regulatory and 
administrative burden on competent authorities has the potential to lead to administrative delays 
and restrict trade. Further, we are concerned that the p roposed Regulation would treat imported 
foods less favourably than China's domestic products. Australia reminds China that its regulations 
must not be used to discriminate against imported goods. Accordingly, Australia urges China to G/TBT/M/83  
 
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  reconsider this Regula tion and to revise it in accordance with its WTO obligations. We note that 
Australia's export and domestic food production systems are underpinned by a robust legislative 
framework. This framework provides confidence to our trading partners that exported p roducts are 
safe, traceable and meet the requirements of the importing countries, including China. Australia has 
an established and successful history of trade in food products with China and seeks to continue this 
strong bilateral trading relationship. We  look forward to China's feedback on our comments and the 
opportunity to engage with the competent authority of China to meet the objectives of the proposed 
measures while safeguarding trade.  
2.211.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Regulations of the People's Republic of China on the Registration and Administration of 
Overseas Manufactures of Imported Food, notified to the Members of this Committee on 16 
November 2020 in document G/TBT/N/CHN/1522 . The Government of Mexi co thanks the 
Government of China for its compliance with the transparency commitments and the opportunity to 
comment on this Regulation. However, we would like to share our main concerns about the 
Regulation, which relate to:  The scope of application : The Regulation lacks clarity with respect to 
the products covered. While Article 6 contains a list of products, there is no certainty that these are 
the only products that must comply with this measure. We would therefore welcome confirmation 
from the de legation of China on the products covered by the Regulation, as well as on whether 
alcoholic beverages are excluded from the Regulation.  Additional administrative procedures for the 
competent authorities in the country of origin : Article  5 of the Regulatio n provides for the issuance 
of various documents by the competent authority of the country of origin, including a letter of 
recommendation, a statement confirming that the enterprise in question meets the requirements 
established by China, and a review and  inspection report. These requirements would represent an 
additional burden not only for the industry, but also for the competent authority in Mexico, which, 
in addition to verifying normal export procedures, would have to  focus its efforts on a  separate 
process solely for China. Furthermore, exporters would have to  certify their products twice. They 
would  firstly  have to  complete a procedure to comply with the export requirements contained in the 
domestic regulations, followed by second procedure to comply  with the export requirements 
requested exclusively by China. This proce ss would impose burdensome workloads on exporters and 
the Mexican authorities , and could therefore contravene the principle of proportionality contained in 
Article 2.2 of the Agreement  on Technical Barriers to Trade (TBT Agreement)  by establishing 
mechanisms that could be considered more restrictive than necessary for an export process.  
2.212.   Risk assessment : Article 6 of the Regulation refers to a risk analysis that may be a 
determining factor for the method of application for the registration and documentation to be 
requested from enterprises for such a procedure. However, no information has been provided o n 
this risk analysis, the manner in which it is determined,  the scientific or technical basis used for the 
determination of the proposed assessment , or whether it is based on an international standard.  In 
light of the above, the delegation of Mexico kindly  requests the delegation of China to:  (i) clarify the 
scope of the products covered by the Regulation, and confirm whether alcoholic beverages are 
included in this list of products;  (ii) explain how the measures contained in the Regulation are 
effective an d proportionate in terms of meeting China's legitimate food safety objective;  (iii) share 
technical and scientific information, as well as the international standards that form the basis for the 
development of this Regulation.  The delegation of Mexico than ks the delegation of China for  giving  
its consideration to this statement and the requests made therein.  
2.213.   The representative of Canada  provided the following statement. Canada appreciates the 
opportunity to comment on China's World Trade Organization (WTO) notification G/TBT/N/CHN /1522  
and urges China to consider the significant negative impacts that these regulations could have on 
trade. Canada is disappointed that China has implemented these regulations immediately following 
the deadline of 15 January 2021 for comments from WTO M embers. As a result, Members' comments 
and concerns have not been taken into consideration in the final implemented regulation. As per 
WTO transparency obligations, a reasonable amount of time, normally understood as a period of not 
less than six months, s hould be provided between the publication of a regulation and its entry into 
force to allow time for industry and Members to review and implement the new requirements. On 
14 January 2021, Canada submitted comments on the proposed measure highlighting that a number 
of the requirements in the draft regulation needed further clarification by China in order for industry 
stakeholders and foreign competent authorities to better understand and comply with the 
requirements. In particular, Canada is concerned that t he additional oversight imposed by China is 
unjustified, overly burdensome and could create serious impediments to trade, such as, the 
maintenance and approval of establishment eligibility lists and additional audits and/or inspections, G/TBT/M/83  
 
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  and other activitie s which are not commensurate with the level of food safety risk associated with 
the notified products. As foreign competent authorities are responsible for ensuring that exported 
food and food products comply with the regulations of the importing country, additional oversight 
due to China's new regulations has created an immediate and long -term administrative burden on 
both Canadian industry and Canada's competent authority. For instance, Article 6 in the regulations 
is so broad that these new regulations w ill result in regulatory oversight for a significant number of 
products with an inherently low food safety risk, effectively becoming a barrier to trade with limited 
apparent benefit to mitigate food safety risks.  
2.214.   Canada appreciates and recognizes China's overall objective to protect human health. As 
such, Canada would appreciate an explanation as to how increasing the administrative management 
and oversight of foreign food establishments that export to China will contribute to meeting food 
safety objective s and whether these new measures are the least trade -restrictive option. In light of 
these concerns, Canada requests that China suspend the implementation of these regulations to 
allow trading partners sufficient time to engage with China and have their co ncerns taken into 
account, including discussions on whether alternate, least trade -restrictive measures were 
considered in the finalization of the measure. Canada also calls on China to notify the final measure 
and provide a transition period for the entry  into force of no less than six months to allow time for 
industry and other Members to adapt. In closing, given China's stated objective of protecting human 
health, Canada is of the view that the proposed measure should also be notified to the WTO Sanitary  
and Phytosanitary (SPS) Committee in order to provide further opportunity for Members to 
comment.  
2.215.   The representative of Japan  provided the following statement. Japan shares the concerns 
expressed by other Members, regarding China's draft regulations on th e registration and 
administration of overseas manufactures of imported food. The proposed regulations would impose 
an obligation on foreign competent authorities to inspect and supervise manufacturing companies in 
their territories in accordance with Chine se laws and regulations, and to confirm them to the Chinese 
Government. In addition, the regulations would expand the scope of food subject to the evaluation 
and inspection, without providing the scientific basis. In addition, there are many unclear points  
from the operational aspects, which may impose heavy burden on overseas manufactures, 
processors, and storage facilities as well as the competent authorities of foreign countries if 
implemented. Japan has been seriously concerned that the China's proposed  regulations would 
create unnecessary trade barriers and have negative impacts on food trade between China and WTO 
Members. Japan would like to request China to provide necessary information and reconsider the 
draft regulation taking into account the comme nts and concerns of Members. Also, Japan would like 
China to provide sufficient transition period and set a clear timeline toward implementation of the 
regulation.  
2.216.   The representative of Switzerland  provided the following statement. As in previous meetings 
of the WTO TBT Committee, Switzerland maintains its concerns regarding the proposed registration 
of overseas manufacturers of imported food. Switzerland understands and supports China's objective 
to ensure that only safe food is imported. We regret that th e proposed measure continues to include 
all food categories irrespective of their risk -profile and seems to be more trade -restrictive than 
necessary to ensure the safety of imported food products. We therefore reiterate our concerns and 
refer to previous s tatements for more detailed comments. Switzerland encourages China to consider 
other ways and means to ensure the importation of safe food products. We stand ready to engage 
with China on this matter and look forward to receiving detailed answers to our qu estions and 
comments submitted previously.  
2.217.   In response, the representative of China  provided the following statement. I would like to 
thank all relevant WTO Members for their concern about China's revision of the Regulations of the 
People's Republic of Chi na on the Registration and Administration of Overseas Manufactures of 
Imported Food (hereinafter referred to as the Regulations of Registration). It is a clear requirement 
of the Food Safety Law of the People's Republic of China to implement the registrati on and 
administration for overseas manufacturers of imported food. With China's further opening -up, the 
trade volume of food imports and the number of registered overseas food production enterprises 
have increased rapidly, and the original Regulations of R egistration fail to meet the requirements of 
the new situation. The purpose of China's revision of the Regulations of Registration is to effectively 
implement the legal provisions, improve the management system, optimize the registration 
procedures, clarif y the responsibilities of all parties, and promote enterprise registration and trade 
development. On 16 November 2020, China notified the WTO the revised draft of Regulations of G/TBT/M/83  
 
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  Registration (Notification G/TBT/N/CHN/1522 ). During the comment period, China received 14 
written comments from Members. China is making in -depth study on the above comments, and will 
positively consider the suggestions raised by all Members.  
2.1.3.19   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme D ecree No. 012 -2018 -SA, G/TBT/N/PER/97 , 
G/TBT/N/PER/97/Add.1 , G/TBT/N/PER/97/Add.2  (ID 61848) 
2.218.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
thank Peru for keeping it informed of the progress of the process to implement the draft Regulation 
established under Supreme Decr ee 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 Man ual'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 nonetheless 
to 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 Cent ral America.  
2.219.   The food industry has informed us of the negative repercussions on trade that a potential 
discontinuation of the use of adhesive labels would have. It should be noted that the use of adhesive 
labels is widely recognized internationally, as suc h labels achieve the same public health protection 
and consumer information 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, perm it the use of supplementary or adhesive labels, as long as it is guaranteed that they will 
not become separated from the container, or in cases where the language on the original label is 
not acceptable to the consumer for whom it is intended.  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 ma kes 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 country 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.  
2.220.   Moreover, we note that  other Peruvian instruments, such as Supreme Decree No. 007 -98-
SA adopting the regulations on sanitary surveillance and control of food and beverages, permit the 
use of stickers to meet labelling requirements, given that this is an appropriate means for th e 
fulfilment of the proposed legitimate objectives. 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 f ulfil the proposed legitimate objectives, 
in accordance with the obligations regarding technical barriers to trade established in the relevant 
World Trade Organization Agreement and in the existing Agreement between our countries.  Costa 
Rica would like to emphasize once again, as it has already done before this Committee, that in light 
of the current situation faced by the world as a result of COVID -19, international cooperation in all 
areas is crucial for tackling the crisis and laying the groundwork for a  swift economic recovery post -
pandemic, through the promotion of trade -facilitating measures, as opposed to measures that might 
create technical barriers to trade and hinder economic recovery.  For all of the above reasons, we 
respectfully request that the Peruvian authorities provide an update on the current status of the 
draft R egulat ion amending the  Manual of Advertising Warnings and the entry into force of the 
requirement prohibiting the use of adhesive labels.  
2.221.   The representative of the European Union  provided the following statement. The European 
Union (EU) appreciates that Peru extended by one year, until 30 June 2021, the possibility to use 
stickers for compliance with labelling requirements for processed foods (Resolución Ministerial 
N°379 -2020-Minsa) . EU recognizes that reliable information to the Peruvian consumer is a legitimate 
objective. However, the practical effect of not allowing the use of stickers is a disproportionate 
burden for foreign manufacturers, in particular SMEs, that have to print t he information on the 
 
48 For previous statements follow the thread under ID 618. G/TBT/M/83  
 
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  product package itself before the product is shipped to Peru. In the EU and in most countries around 
the world, stickers are allowed for food products, provided that the information is accurate, and the 
stickers are not easily removab le. The EU would like to repeat the invitation to Peru to provide for a 
permanent possibility to use stickers. We are committed to working with Peru bilaterally on this 
issue.  
2.222.   The representative of Brazil  provided the following statement. Brazil regrets ha ving to once 
again express its concerns regarding labelling requirements expressed in the Manual of Advertising 
Warnings approved by Supreme Decree 012 -2018-SA (notified under G/TBT/N/PER/97/Add.1 ) and 
amended by Supreme Decree 015 -2019-SA (unnotified). Brazil shares Peru 's endeavour to ensure 
the highest health standards through technical regulations that help better inform consumers. We 
would like to thank Peru for clarifying, in the last Committee meeting, the reasons for forbidding the 
use of stickers. We also apprecia te its willingness to engage bilaterally with Brazil on this topic. The 
use of stickers is a widespread practice internationally, as it does not affect the provision of reliable 
information to consumers.  Codex standard CODEX -STAN 1 -1985 for pre -packaged go ods, Articles 
8.1.1 and 8.2.1, explicitly allows for the possibility of using additional labels or stickers, as long as 
they are attached to the packaging and if the language of the original label is not necessarily that of 
the consumer for whom it is inte nded. Despite Peruvian legitimate concerns with deceptive practices, 
advances in labelling technologies allow for their safe affixation. Brazil would be willing to share with 
Peru its regulatory experience related to such labelling requirements. We acknowl edge that, 
according to Supreme Decree 021 -2020-SA, the entry into force of the prohibition on stickers was 
delayed until 30 June 2021. However, Brazil would like to respectfully ask Peru to permanently align 
its labelling requirements with current interna tional standards established under the Codex and 
withdraw the prohibition of stickers for the products under the scope of the Manual of Advertising 
Warnings. Brazil considers such postponement a provisional solution and will continue to raise this 
STC unti l Peru permanently removes its burdensome requirements for food labelling.  
2.223.   The representative of Colombia  provided the following statement. Colombia would like to 
reiterate its concern regarding the Manual of Advertising Warnings prepared in accordance wit h 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. Under the above -mentioned regulations, the deadline 
was set for to 30  June 2021 for the use of adhesive advertising warning labels that was provided for 
in paragraph 8.3 of Supreme Decree No.  012-2018 approving the Manual of Advertising Warnings.  
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. Colombia considers that allowing the use of 
stickers does not distort the purpose of Law No.  30021 on heal thy 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, whether 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 considers that the non -acceptance of 
stickers is a provision that is more restrictive than necessary and may become an unnecessary 
obstacle to trade, violating Art icle 2.2 of the TBT/WTO  Agreement on Technical Barri ers to Trade, 
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 (...) ".  
2.224.   A technical measure on labelling that is so specific, which  must be implemented in the 
country of origin and does not allow the use of alternatives such as stickers with the required 
information, is a technical barrier to trade. It constitutes a major barrier to market access for 
products from countries such as Co lombia, especially for small and medium -sized enterprises whose 
current and projected sales volumes in Peru cannot justify the expense of making a "factory" label 
designed specifically to comply with the regulation.  It should be recalled that most exporter s to Peru 
are enterprises whose economies of scale and volumes of trade do not warrant the increased expense 
of developing special packaging for trade with a country that imposes an unnecessary barrier of this 
nature.  Furthermore, imposing this type of unn ecessary trade -restrictive measure runs counter to 
international labelling practice and the Codex Alimentarius, such as Article 8 on Presentation of 
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, which 
refers to the preparation, adoption and application of technical regulations and reads:  "(...) 2.4 
Where technical regulations are required and relevant international standards ex ist or their G/TBT/M/83  
 
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  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 fulfilm ent of the legitimate objectives pursued, for instance 
because of fundamental climatic or geographical factors or fundamental technological problems". In 
view of the foregoing , Colombia once again requests P eru to extend the application of the rule 
allowin g the indefinite use of adhesive labels or stickers with warning icons and messages on food 
packaging.  
2.225.   The representative of the United States  provided the following statement. The United States 
supports the interventions of other Members, and notes our pr evious TBT Committee interventions 
on this measure. We request that Peruvian authorities modify the provisions established in the 
Manual, so as to allow compliance with labelling requirements through an extension for the use of 
stickers.  
2.226.   The representative  of Chile provided the following statement. Chile would like to support and 
share the trade concern raised by the European Union, Costa Rica, Brazil, Colombia and the United 
States regarding the proposal to implement front -of-pack nutrition labelling for f ood products in 
PERU. The notified draft sets out a mandatory front -of-pack nutrition labelling system indicating that 
the products are in "excess of" or "high in" certain nutrients for prepacked foods whose content of 
energy, sugars, saturated fats, trans  fats and sodium exceed certain parameters. In this regard, 
Chile shares the ultimate public policy objective sought, recognizes the importance of the 
relationship between diet and health, and acknowledges that providing the elements of the nutrition 
information front -of-pack can be a useful tool for consumers, as part of a multidimensional strategy 
to address overnutrition.  As is well -known, Law No.  20.606 on the nutritional composition of foods 
and food advertising came into force on 27  June 2016 in Chile . This law was the subject of extensive 
debate, both nationally and internationally, including in this Committee, and in this regard we would 
like to highlight that its implementation has been gradual, divided into three incremental phases. 
On this point, and in order, on the one hand, to achieve the objective of the public health policy and, 
on the other, to avoid creating an additional barrier to trade in goods, the law in question provided 
for the use of stickers or adhesive labels within its implementat ion mechanisms as a way to comply 
with the front -of-pack labelling of food. This measure is generally applied to imported products that 
will be sold on the domestic market that are covered by this law and its respective regulations 
(DECREE13/2015).  
2.227.   Regardi ng entry into force, the proposed Regulation allowed for an additional implementation 
period for its entry into force, which ends on 1  July of this year. This responds to the importance of 
adaptation and the conditions specified for amending the front -of-pack labelling of foods, while 
allowing time for the technological adaptation of food products.  In light of the above, Chile requests 
PERU to consider this mechanism as a permanent measure, taking into special consideration Chile's 
successful experience, wh ich is aimed at meeting policy objectives without creating an unnecessary 
barrier to trade (relabelling/repackaging), which will mean higher final product costs. There are trade 
facilitation measures – such as the use of stickers/adhesive labels – that hav e been implemented 
successfully without losing sight of the objective of complying with the public policy on front -of-pack 
labelling of "high in" foods.  Chile has been, and is, willing to collaborate and share its experience in 
this regard, and to establis h a mechanism of information exchange at a technical level between the 
competent regulatory authorities. Independent studies show the positive impact of allowing the use 
of self -adhesive labels or "stickers" indelibly marked on the packaging of products im ported into the 
country on its implementation in Chile and inclusion in the Regulation. This alternative measure 
emerged in response to the problems raised by the international food industry in the process of 
public consultations on the draft regulation be fore this Committee. This authorization of "stickers" 
provided for in the Regulation has so far been found to be helpful in supporting its implementation, 
and avoiding a technical obstacle to trade, taking account of the principles of evaluation of food 
labelling policies, and demonstrates a positive response to the first stages of implementation of this 
law (since 2016). Furthermore, it can be said that the labelling policy followed by Chile is on the 
right track, according to the expected results for this  type of policy. Therefore, the use of another 
front-of-pack labelling mechanism is not recommended, without prior scientific evaluation, or 
changing the strategies for its implementation. In other words, allowing the use of self -adhesive 
stickers in the l abelling of imported products is recommended, in order to adapt the labelling of the 
products to the domestic regulation, is recommended.  In light of the above, Chile requests Peru to 
reconsider the measure and to allow the use of stickers on a permanent b asis. G/TBT/M/83  
 
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  2.228.   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 Warnings approved by 
Supreme Decree No.  012-2018-SA, by establishing that all food and bever ages must display 
advertising warnings, where appropriate, and that the use of stickers featuring advertising warnings 
is permitted for one year from the entry into force of the Manual. The deadline for the use of adhesive 
advertising warning labels establ ished in the Supreme Decree has been extended until 30 June 2021.  
Guatemala recognizes Peru's legitimate objective of protecting human health and providing 
consumer information . The notification G/TBT/N/PER/97/Add .2 extends the deadline for the use of 
stickers on packaging in compliance with the regulation to 30 June 2021. As mentioned, CODEX 
CXS 1-1985, General  Standard for the Labelling of Prepackaged Foods, states that a supplementary 
label containing the mandat ory information in the required language may be used and shall fully and 
accurately reflect the information on the original label . Peru is requested to reconsider the measure 
established as it is more trade-restrictive than necessary. The use of such label s is widely recognized 
internationally, as they fulfil the same public health protection and consumer information purposes 
with the application of supplementary adhesive labels.  Regarding the points made to Peru at previous 
meetings on Supreme Decree No. 0 15-2019-SA, Guatemala's position remains the same.  
2.229.   In response, the representative of Peru provided the following statement. As we have done 
in previous meetings , Peru wishes to reiterate that it is committed to its work to protect the health 
of its citize ns and vulnerable groups, such as children and adolescents, through public policies aimed 
at achieving this goal, in accordance with its international trade commitments in this domain . In this 
connection, Peru is seeking to ensure that the information cont ained in the Manual of Advertising 
Warnings reaches consumers clearly and effectively, so that they can make informed choices. As 
has been pointed out, Peru, by means of Supreme Decree No.  021-2020-SA, has extended the period 
during which the use of adhesi ve advertising warning 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.  However, with regard to the concerns expressed by  
some Members, Peru is currently taking the necessary action in order to assess the best mechanisms 
for achieving its legitimate objective and enhancing trade facilitation . Lastly, we reiterate that Peru 
wishes to honour its WTO commitments and therefore r eaffirms its commitment to not preparing, 
adopting or applying technical regulations that may create unnecessary barriers to trade, as 
established in the Agreement on Technical Barriers to Trade.  
2.1.3.20   India - Quality Control Orders for Chemical and Petrochemica l 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 , 
G/TBT/N/IND/175 , G/TBT/N/IND/176 , G/TBT/N/IND/177 , G/TBT/N/IND/186 , 
G/TBT/N/IND/187 , G/TBT/N/IND/188 , G/TBT/N/IND/191 , G/TBT/N/IND/193 , 
G/TBT/N/IND/194 , G/TBT/N/IND/199  (ID 63049) 
2.230.   The representative of the European Union  provided the following statement. The European 
Union would like to r ecall 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 whole range of chemical products under the HS chapters 28 and 29. Be tween April 2019 
and November 2020, India has made to the WTO 32 notifications concerning chemical products. Of 
these, 22 are covering petrochemicals (HS chapter 29), including such important mass products like 
methanol, toluene, ethylene glycol, acetic ac id, terephtalic acid, acetone and melamine, and another 
10 deal with inorganic chemicals (HS 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 Indian standards which are now 
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 onc e, within 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 could potentially be discriminatory in nature. The EU 
would like to recall Article 2.2 of the TBT Agreement, according to which Members shall ensure that 
 
49 For previous statements follow the thread under ID 630. G/TBT/M/83  
 
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  technical regulations are not prepared, adopted or applied with a view to or with the effect of creating 
unnecessary obstacles to international trade. The EU would like to encourage India to a lign the BIS 
standards with international approaches.  
2.231.   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 t o thank India for postponing the implementation of a number of chemical and 
petrochemical Orders for another 180 days, which were announced at (website) on 24 December 
2020. The measures of our specific concern are those regarding phthalic anhydride, n - Butyl Acrylate 
and terephthalic acid (notified by G/TBT/N/IND/116 , G/TBT/N/IND/123  and G/TBT/N/IND/124 ). It 
gives our manufacturers more time to prepare, yet we are still concerned about whether all the 
procedures can be completed in time considering the persistent impact of the pandemic. Besides, 
the following concerns that we have raised in previous meetin gs remain and a response by India 
would be much appreciated. Firstly, we would like to seek information from India on the rational and 
risk assessment of changing the current voluntary system to a compulsory certification system, 
which to our knowledge has  never been adopted by any WTO Members for the management of 
chemicals, and where less trade -restrictive alternative approaches exist, for example, registration 
of chemicals. Secondly , the requirement for annual "on -site" factory visit/inspection is costly  to fulfil 
especially for manufacturers located outside India. As BIS Conformity Assessment Regulations 2018 
(BIS Regulations) stipulates that "the need for carrying out the inspection shall be decided keeping 
in view the risk associated with,"  we seek fur ther information from India on the risk assessment 
underpinning the new Orders' decision that there is a need to carry out annual factory 
visit/inspection. In particular, we call for India to share with Members the risk factors and other 
reasons that preve nt India from adopting less trade -restrictive alternative approaches.  
2.232.   Thirdly, according to BIS Regulations, the license is valid for one to two years for initial 
application, and one to five years for renewals. In practical, the short validity of license and lengthy 
certification procedures, which also include on -site inspection, make it difficult for foreign 
manufacturers to obtain approval for a renewal within 12 months after the issuance date.  We urge 
India to give reasonable validity period of licence for both domestic and foreign applicants on a non -
discriminatory basis taking into account the practical difficulties faced exclusively by foreign 
manufacturers. Fourthly, India indicated that there is no provision under Scheme1 of BIS Regulation 
to accept  conformity assessment results conducted by foreign bodies. As this creates a significantly 
higher burden for manufacturers located outside India,  we once again urge India to consider 
providing opportunities for testing laboratories and inspection bodies f rom other WTO Members to 
participate in the conformity assessment procedures by accepting conformity assessment results 
from accredited bodies under the ILAC MRA framework. Fifthly, we would like to call for India's 
attention to the on -going impact of COVI D-19 on conformity assessment activities. The access of 
products manufactured outside India to Indian market is tantamount to a factual denial when 
arrangement for a factory inspection visit by BIS is still not possible due to the travel restrictions. 
Hence, we would like to suggest that the Indian Government consider postponing the 
implementation date of the measures mentioned above until a time when foreign manufactures are 
on the same level playing field with its domestic manufacturers, or adopting tempo rary measures to 
address the unique situations faced by foreign manufacturers. Such measures may include 
exempting the on -site factory visit requirement for foreign manufacturers, authorizing qualified 
inspection bodies located in the exporting Members (e.g. inspection bodies accredited under ILAC -
MRA framework) to facilitate factory inspections in lieu of Indian delegation so as to mitigate the 
problem. We would be grateful if the above -mentioned comments could be taken into account and 
look forward to a w ritten response.  
2.233.   The representative of the United States  provided the following 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 Bureau of Indian Standards (BIS) standards mandatory for 72 identified 
chemicals and petrochemicals. We are also aware that, as of February 2021, India's MoCF has 
notified 35 Quality Con trol Orders (QCO) to the WTO TBT Committee. Each QCO appears to identify 
substances that correspond to or fall under the 72 identified substances in the October 2019 meeting 
notice. We understand that each QCO proposes to mandate compliance to BIS standard s for the 
identified substance. We continue to appreciate India's efforts to notify these QCOs to the WTO TBT 
Committee and to provide stakeholders with the opportunity to submit comments. However, we note 
that India's notified QCOs do not include links to  and/or copies of the referenced standards that the 
QCOs seek to mandate. U.S. industry reports that the referenced standards are either infrequently G/TBT/M/83  
 
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  posted to the BIS website or require BIS credentials for access. Unless India makes readily available 
the BIS standards that the QCOs propose to mandate, interested parties will be unable to become 
fully acquainted with the QCOs or to provide meaningful comments. We kindly request that India 
provide links to and/or copies of the BIS standards identified in the  35 previously notified QCOs and 
for all future QCO notifications. With respect to the previously -notified QCOs, we would recommend 
that such links and/or copies be notified as addenda. We request that India explain how it will engage 
with international st akeholders in developing these technical regulations and conformity assessment 
procedures and to provide details regarding the specific timeline and implementation dates for the 
notified QCOs. We encourage India to use relevant international standards and relevant guides or 
recommendations issued by international standardizing bodies when revising BIS standards and 
conformity assessment procedures. The United States refers to its previous interventions on this 
matter, including the concerns raised in the Oc tober 2020 WTO TBT Committee meeting.  
2.234.   The representative of Canada  provided the following statement. Canada reiterates the 
concerns it raised at the May and October 2020 TBT Committee meetings regarding all "Quality 
Control Orders " on chemical and petroche mical substances notified by India since November 2019. 
While drawing the attention of Members to our previous statements on the overall approach taken 
by India to make standards mandatory, we want to take this opportunity to again highlight that we 
remain  deeply concerned with the method followed by India in notifying the Quality Control Orders 
to interested Parties. The one -page model document provided by India to explain its Quality Control 
Orders notifications does not appear as a genuine exercise of tr ansparency. The document fails to 
explain the new measures and its objectives, except for statements such as: "the Central 
Government […] is of the opinion that it is necessary or expedient to do so in the public interest ". 
These declarations of the new ma ndatory nature of the Indian Standards are made without 
facilitating stakeholders' access to any related information on them, including directions on where 
the latest official version of the now -mandatory Standards can be found - some of which are decades 
old. If interested parties and stakeholders are not provided with the relevant information that led to 
the regulatory proposal, then they can hardly provide substantive comments and new information 
that could inform India's decision -making process. This si tuation generates significant concerns vis -
à-vis the obligations of the TBT Agreement, notably Articles 2.2 and 2.5, which state that Members 
must provide interested parties and stakeholders a genuine consultation period to review the 
measures and provide comments.  
2.235.   Despite concerns raised at the TBT Committee meeting since May 2020, India continues to 
replicate this one -page notification method, as seen in the recent notifications on Quality Control 
Orders, such as Polyester Industrial Yarn (Quality Control ) Order, 2020 ( G/TBT/N/IND /188) and 
Synthetic Micro -Fibres for use in Cement -Based Matrix (Quality Control) Order, 2020 
(G/TBT/N/IND/194 ), both published on 12 January 2021. Canada recognizes and strongly supports 
Members' right to regulate. However, Members must ensure that such actions do not create 
unnec essary obstacles to international trade, and follow internationally agreed -upon rules and 
processes to ensure a level playing field and the viability of the international trading system. The 
lack of transparency, justification, and overall clarity displaye d by India on these measures goes 
against this international regime. Therefore, Canada urges India to revise and modernize the way it 
notifies its measures on Quality Control Orders to make them transparent and accessible for all 
stakeholders.  
2.236.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to support the delegations of the EU, Chinese Taipei, United States and Canada. First of all, 
Korea highly appreciates India for the postponement of enforcing th e Toluene and Terephthalic Acid 
Quality Control Order (QCO), which resolves difficulties of Korean companies. Korea respects the 
efforts of India to introduce Acetone QCO for the health and safety of Indian people. Furthermore, 
Korean companies are committ ed to comply with the regulation of India. However, Korea would like 
to deliver requests as Korean companies have difficulties regarding the enforcement date of Acetone 
QCO, 2020 of India. Implementation of Acetone QCO has been postponed and it is schedule d to take 
effect in 14 March 2021, however, Korea understands that it is still difficult for local BIS to provide 
normal services due to COVID -19. The Korean companies completed the certification application in 
June last year, but additional certification procedures such as factory audit have not been conducted 
yet after the document screening was completed. Therefore, Korea requests again that India 
postpone the implementation of Acetone QCO by more than six months or to take alternative 
measures such as t emporary factory audit exemption for a limited period, considering the delay in 
certification process due to COVID -19. G/TBT/M/83  
 
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  2.237.   In response, the representative of India provided the following statement. 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 Bureau of Indian Standards (BIS) standards mandatory for 72 identified 
chemicals and petrochemicals. I n line with this notice, India so far has issued 35 (February 2021)  
Quality Control Order for chemicals and petrochemicals of chapters 28 and 29 as mandatory, which 
is in line with international practices. India has formulated individual standards of speci fic chemicals 
indicating discreet and separate numbers under the BIS Act, giving technical characteristics and 
details of testing methods. Since each chemical has different BIS standard number, possesses 
different characteristics and different testing meth ods, India has not preferred to file a single 
comprehensive mandatory notification. As per Article 2.2 of TBT agreement, Members are allowed 
to formulate Technical Regulations to fulfil legitimate objectives inter alia  national security 
requirements, preve nt deceptive practices, protect human health or safety, animal or plant life or 
health, or environment. As per the laid down procedure, the draft Quality Control Orders (QCO) were 
notified to the WTO TBT Committee, giving opportunity to Members to give the ir comments and 
objections within 60 days. These standards are made mandatory to protect human health and the 
environment. Even if other countries have not formulated TRs for such chemicals, the number of 
TRs of chemicals and petrochemicals in India is les s than other nations. In the past, for a long time, 
the Indian standards of chemicals and petrochemicals were voluntary in nature. The trade of 
chemicals and petrochemicals usually takes place as per the specifications settled between the 
manufacturer and buyer irrespective of the specifications stipulated in the BIS standard, which 
sometimes resulted in dumping poor quality chemicals into India. Many chemicals are toxic and 
hazardous in nature. The impurities such as heavy metals, cyanides, isocyanates, ha lides, etc. enter 
the human and plant chain thereby harming the human and animal life.  
2.238.   Under mandatory standards regime, safe, reliable and quality chemicals are expected to be 
available. TRs for chemicals and petrochemicals have not been formulated to cre ate unnecessary 
obstacles to international trade. The standards have been made mandatory after carrying review of 
existing standard and following stake holder consultation. This exercise is completed in consultation 
with various leading manufacturers to en sure to reflect new testing methods. This measure does not 
hinder the ability of foreign manufacturer to penetrate and reach into Indian chemical market. There 
would be no delay on the part of Indian regulator in clearance of import consignments, provided the 
supplier satisfies the conditions stipulated in the QCO. Regarding the scope of the QCOs, there is no 
discrimination as they apply to domestic and foreign manufacturers. The BIS formulates the 
standards by studying all available international standards . Finally, standards are aligned with the 
international standards. Presently India is in the process of formulating Chemicals (Management and 
Safety) Rules. The aspect of unnecessary animal testing and the aspect of Mutual Acceptance of 
Data will be looked  into. 
2.239.   As regards the links for the information of the QCO, the BIS standards are available at the 
link below.50 DCPC has notified the draft Quality Control Orders on chemicals and petrochemicals 
under the provisions of BIS Act 2016 and Rules and Regulatio ns framed there under, which envisages 
conformity assessment Scheme -1 of BIS (Conformity Assessment) Regulations 2018. As per draft 
QCOs, the product specified therein shall conform to corresponding Indian Standard and shall bear 
the standard mark under th e licence from BIS as per Scheme -1 mentioned above. This QCO is 
equally applicable to domestic and foreign manufacturers who intends to export their products in 
India. Under the provisions of BIS Act 2016, no person shall manufacture, import, distribute, s ell, 
hire, lease, store, or exhibit for sale chemicals and petrochemicals notified in the QCO without a 
standard mark, except for a valid licence. For persons selling these chemicals without requisite 
certificate (licence), penal provisions of the BIS Act 2016 shall be applicable. The violators shall be 
prosecuted as per the Act and are punishable with fine or with imprisonment also. The requirement 
for use of Standard Mark as per Scheme -1 is given in BIS (Conformity Assessment) Regulations 
2018. The copy of the same is available on BIS website.51 Under the provisions of Scheme -1 of BIS 
(Conformity Assessment) Regulation 2018, 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 o ne, but up to five 
years.  
2.240.   Under the provisions of Scheme -1 of BIS (Conformity Assessment) Regulation 2018, BIS 
grants a licence to the manufacturer based on successful assessment of the manufacturing 
 
50 https://standardsbis.bsbedge.com/  
51 www.bis.gov.in  G/TBT/M/83  
 
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  infrastructure, production process, quality control and testing capabilities of a manufacturer through 
a visit to its manufacturing premises. Conformity of the product to the relevant standard is also 
established through third party laboratory testing located in India or testing in the manufacturing 
premises or  combination of both. There is no provision under Scheme -1 of BIS (Conformity 
Assessment) Regulation 2018, to accept quality control assessments conducted by foreign firms and 
Labs. As per Quality Control Orders on chemicals and petrochemicals, every produ ct shall conform 
to corresponding Indian standards specified therein and shall bear the standard mark under the 
licence from BIS as per Scheme -1 of BIS (Conformity Assessment) Regulation 2018. The standards 
of chemicals and petrochemicals which were notifi ed by DCPC, were reviewed by BIS and due 
consideration were given to international standards like ISO/ASTM, wherever available.  
2.1.3.21   European Union - Non-renewal of the approval of the active substance 
mancozeb, G/TBT/N/EU/712  (ID 62752) 
2.241.   The representative of Australia  provided the following statement. Australia reiterates 
previously -raised concerns and supports the concerns raised by other Members.  
2.242.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concer n raised by the United States, Paraguay, Brazil, Australia, Indonesia 
and Colombia in relation to the draft Implementing  Regulation notified by the European Union, under 
which approval for the use of mancozeb would not be renewed.  Costa Rica recognizes tha t 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 s cience -based and should not create unnecessary 
barriers to trade, especially at a time when the pandemic continues to affect the economic recovery 
of international markets.  To assess just how crucial the substance mancozeb is to agricultural 
production in Costa Rica, it is sufficient to note that it is currently used for more than 20 crops that 
are grown for export and domestic consumption, and is therefore vital for ensuring the supply of 
food. Mancozeb is also used to combat pests of economic importance, particularly in banana 
production.  Costa Rica is the world's second largest exporter of bananas, and the first country to 
have obtained a geographical indication for this product. 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 that would be generated by the ban on the use of 
mancozeb and the subsequent reduction in MRLs for this substance in bananas.  Despite Costa Rica 's 
many reservations about the reasoning behind EU regulations, the Costa Rican banana sector 
continues to seek alternatives to mancozeb. However, time wi ll be needed to complete the relevant 
tests and approval procedures for any alternatives found. Costa Rica therefore once again requests 
that the EU postpone the non -renewal process and subsequent reduction of MRLs for mancozeb, so 
as to give the national sanitary and phytosanitary authorities a reasonable period of time to respond 
to the numerous challenges posed by the COVID -19 pandemic and find an alternative substance so 
that Costa Rican farmers can continue to grow bananas and export the volumes requir ed to meet 
the EU market demand.  
2.243.   The representative of Brazil  provided the following statement. Brazil regrets having 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 . We thank the EU for responding to our comments in 
October 2020. As stated in our comments, 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. 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. 
Mancozeb is an important tool for the management of fungicide resistance to control soybean rust, 
one of the most devastating diseases for this crop. It is used as a crop protection additive, intended 
to incr ease 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 t he EU market before late 2020. We also 
 
52 For previous statement s follow the thread under ID 627. G/TBT/M/83  
 
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  urge European authorities to consider establishing transition periods that are adequate to the 
production cycle of the affected crops. 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. 
Does the EU consider that the TBT notification was made at an early stage in order to take other 
Members' views into consideration? What other less trade -restrictive alternativ es were considered 
in the development of said draft regulation?  
2.244.   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 
April 2020 relating to the non -renewal o f the approval of the active substance mancozeb. The EU 
has been adopting measures resulting in the non -approval of the use of plant protection products, 
which is affecting exports from Colombia. Measures to suspend or not approve the placing on the 
market  of many active substances , and the s ubsequent reduction of their MRL s to the minimum level 
of detection, are being taken without strong scientific evidence and without demonstrating that they 
are indeed the least trade -restrictive measures to achieve an a ppropriate level of protection.  
Mancozeb is a fungicide used in more than 70 fruit and vegetable crops to control over 
400 phytopathogenic fungi that attack the crops. Its main use is to prevent the fungi from developing 
resistance to curative fungicides.  In Colombia, the active substance mancozeb is essential to protect 
banana crops against pests and diseases such as "Black Sigatoka ". Recently, the EU also banned the 
marketing of chlorothalonil, which is the main tool for controlling this fungus.  
2.245.   Banning m ancozeb would leave banana -producing countries without any phytosanitary tools 
to control this disease, resulting in significant economic losses and highly regrettable consequences 
for the environment and the economic sustainability of banana crops, with t heir respective social 
implications.  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 provision s 
of the WTO  TBT Agreement.  It also constitutes a violation of Article  2.2 of the TBT Agreement, given 
that, 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.  Even though in this and various other cases we have 
requested the EU to provide information on the dea dline for adoption of the standard and on the 
impleme ntation of maximum residue limits, the EU has failed to respond to these requests. We recall 
that Article 2.12 of the TBT Agreement provides that "Members shall allow a reasonable interval 
between the publication of technical regulations and their entry in to 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 ". 
2.246.   The information available indicates that the European Food Safety Authority (EFSA) has 
initiated the procedure for revising MRLs for mancozeb. In this regard, we ask the European Union 
how, as interested trading partners, we can participate in this process , how our comments will be 
taken into account and what time frames are envisaged for a decision by EFSA.  As the procedure 
currently being followed by EFSA is different from the international public consultation process that 
should be followed under the TBT  Agreement, we urge the EU to notify the relevant standards at an 
early appropria te stage and take into account M embers' comments, in line with Article  2.9. We also 
recall that, in the context of the COVID -19 pandemic, Colombia, together with a broad group  of 
countries, requested the EU to temporarily suspend review processes of market approvals for plant 
protection substances, as well as the entry into force of regulations in this area. This call has also 
not been taken into consideration and we therefore reiterate our invitation to the EU to provide us 
with a response and to initiate a dialogue to allow us to explore alternatives. Lastly, we invite the 
EU to follow the recommendations of good regulat ory practices, under which standards  must be 
based on clear and objective information  and on the promotion of open dialogue with stakeholders, 
transparency and the minimizing of market distortions.  
2.247.   The representative of Guatemala  provided the following statement. Guatemala shares the 
concern regarding the absenc e of information on the scientific evidence of harm to human health 
caused by the consumption of fruit and vegetables, particularly those produced in Latin America.  
The European Union has previously mentioned that it has identified potentially negative hea lth 
effects of mancozeb.  It has failed to provide countries affected with information on the contamination 
of products that have been assessed with the scientific information available.  Moreover, the G/TBT/M/83  
 
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  European Union has not presented any scientific evidence  of the supposed danger and harmful 
nature of mancozeb in the production and exportation of fruit and vegetables in Latin America.  The 
European Union has notified the Committee on Technical Barriers to Trade of the non -renewal of the 
approval of the active  substance mancozeb. This will lead to a subsequent revision of the current 
permitted MRLs, which will have a direct impact on agricultural exports to the European  Union.  
Mancozeb is key for the production of a number of strategic agricultural crops that a re exported to 
the European Union, such as fruit (bananas and plantains, among others) and vegetables, which 
would affect other countries in Latin America.  
2.248.   In terms of other types of agrochemicals, there are very few alternatives with multi -site 
properties  available for the control of fungi. Mancozeb, as a multi -site fungicide, attacks different 
parts of the fungus and creates no resistance.  In the case of plantains and bananas, mancozeb is 
essential given the absence of alternatives offering the same effec tiveness. Black Sigatoka is caused 
by the fungus Mycosphaerella fijiensis, which invades and necrotizes the leaf tissue, causing leaf 
death in perennial banana and plantain crops.  Black Sigatoka is the disease that has the greatest 
economic impact on banan a and plantain crops worldwide and can only be successfully controlled 
with mancozeb.  The ban on the use of mancozeb will have an economic and social impact on 
Guatemala, given that both plantain and banana crops are a significant source of job creation, f oreign 
exchange and food for the country.  The growth of these crops creates over 280,000 direct and 
indirect jobs and therefore affects over 1,120,000 Guatemalans.  Banana exports accounted for 30% 
of Guatemala's total exports of traditional products in 201 8 and 11.2% of total exports from the 
customs territory.  The banana is the world's most consumed and exported fruit and, as a result, 
there has been a significant rise in the foreign exchange generated by this crop. Such earnings have 
been on the increase since 2018, ranging from USD  800 million to USD  1 billion.  In light of the 
above, we request the EU to maintain the current MRLs for mancozeb so as to avoid affecting the 
production and exports of Guatemala and other Latin American countries, particularly in view of the 
economic and social impact that this type of measure will have on developing countries. We reiterate 
the request made in documents G/SPS/GEN/1778  and G/TBT/GEN/296 , especially given the current 
COVID -19 situation.  
2.249.   The representative of Ecuador  provided the following statement. We thank Australia, Brazil, 
Colombia and Costa Rica for including this item on the agenda. 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 
principle. 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 and maintain its MRLs as a risk management measure to protect 
the health of consumers in the EU and avoid possible effects that could result in bar riers to trade.  
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 
consequences for the environment and the economic sustainability of banana crops, which, in turn, 
would lead to socioeconomic consequences, given that this sector creates a significant number of 
jobs, since Ecuador is, as is well known, the world's top exporter of this fruit.  Lastly, we reiterate 
the ques tions we posed 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.  
2.250.   The representati ve of Paraguay  provided the following statement. Paraguay co -sponsors this 
trade concern relating to the substance m ancozeb.  Paraguay  refers to its previous statements. Like 
other Members, we are concerned by the EU's decision to base measures on a hazard -based 
approach without a proper risk analysis and without complying with scientific principles. This has 
resulted in the reduction of MRLs and the non -renewal of substances such as mancozeb, 
chlorothalonil  and picoxystrobin , which will cause significant da mage to Paraguay's export  sector . 
As we have previously stated , 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 c onditions, 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, G/TBT/M/83  
 
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  we do not agree with the method used to achieve them, as it is not based on scientific evidence . We 
urge the EU  to consider less trade -restrictive alternatives and base its measures on conclusive 
scientific evidence . 
2.251.   The representative of Chile provided the following statement. As noted in previous TBT 
committees, Chile would like to echo th e comments made by Costa Rica, Australia, Brazil, Colombia, 
Guatemala, Ecuador and Paraguay.  We should again like to express our ongoing concern and will 
continue to follow up on this matter, especially with regard to establishing a reasonable period of 
time to find potential alternative substances for the development of productive processes, in this 
case for mancozeb.  
2.252.   In response, the representative of the European Union  provided the following statement. We 
have provided detailed explanations on this issue in previous meetings. On 17 April 2020, the 
European Union notified to the TBT Committee a draft Commission Implementing Regulation 
concerning the non -renewal of the ap proval of the active substance Mancozeb, in accordance with 
Regulation (EC) No 1107/2009 on the placing of plant protection products on the market. 
Implementing Regulation (EU) No 2087/2020 entered into force on 4 January 2021. The non -renewal 
was based on  a scientific assessment conducted under Regulation (EC) No 1107/2009 by experts 
from the EU member States and the European Food Safety Authority (EFSA). Since EFSA concluded 
that Mancozeb does not meet the approval criteria as outlined in Article 4 of Reg ulation (EC) No 
1107/2009, the approval of Mancozeb was not renewed. EU member States must withdraw existing 
authorizations for plant protection products containing Mancozeb at the latest by six months from 
the date of entry into force of the Implementing Regulation (by 4 July 2021). The grace period, in 
line with Article 46 of Regulation 1107/2009, shall expire, at the latest, after 12 months from its 
entry into force (by 4 January 2022). The withdrawal period for existing authorisations and the grace 
period have been extended, when compared to the original proposal, in order to accommodate 
requests. Following non -approval and the expiry of all grace periods for stocks of products containing 
this substance, separate action will likely be taken on Maximum Re sidue Levels (MRLs) and a 
separate notification will be made in accordance with SPS procedures.  
2.1.3.22   China - Commercial Cryptography Administrative Regulations (ID 64453) 
2.253.   The representative of the European Union  provided the following statement. The EU is 
conce rned 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, concerns relate to (i) the scope of the law; (ii) the lac k of clarity of concepts & precision 
of procedures; (iii) the protection of intellectual property; (iv) the imposition of pre -market & export 
controls; (v) the requirements around testing & certification; (vi) the imposition of additional 
"national securit y reviews"; and (vii) the use of domestic standards, along with the lack of 
meaningful access to pertinent Chinese standards development organisations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in or der to ensure that 
legal and regulatory requirements are applied on a non -discriminatory basis, do not favour specific 
technologies, 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 
Standardisation Technical Committee" (CISTC) to foreign -invested industry based in China. The EU 
would appreciate its comments being taken into consideration and invites the SCA to notify the draft 
regulations to the WTO.  
2.254.   The representative of the United States  provided the following statement. The United States 
has concerns regarding China's draft Commercial Cryptography Administrative Regulations, issued 
by the State Cryptography Administration on A ugust 20, 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 trade restrictive cryptography -related constraints on foreign ICT products. Does 
China  intend to notify this measure to the TBT Committee and allow for additional stakeholder 
comments? The provisions in the draft measure may raise serious concerns under the WTO 
Agreements, and appear to conflict with globally accepted practices to assess en cryption in 
commercial ICT applications. We understand that China has received numerous comments on this 
draft. We hope that China 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. The draft measure would establish a licensing scheme for all 
 
53 For previous statements follow the thread under ID 644. G/TBT/M/83  
 
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  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 
treatment commitments? What steps is China taking to ensure the scheme will not be operated as 
an unnecessary obstacle to trade?  
2.255.   Given China's TBT obligations in Article 5, what steps is China taking to ensure its 
cryptography accreditation, testing and certification 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 f avourable than those accorded to domestic products? Although the draft measure 
ostensibly encourages participation in "the development of international standards for commercial 
cryptography ", Articles 10 to 12 appear to mandate compliance with Chinese stan dards, which may 
diverge from international standards. In addition, the draft measure includes a standard -setting 
process for commercial cryptography that appears to provide a different level of openness to 
domestic participants as compared to foreign part icipants. In the United States' view, China should 
adopt and use relevant international 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 measur e, and how China intends to consider the public comments it received.  
2.256.   The representative of Canada  provided the following statement. On 17 September 2020, 
Canada provided comments to China's State Cryptography Administration on the draft revised 
Regulation s on the Administration of Commercial Cryptography promulgated on 20 August 2020. 
Canada continues to look forward to receiving a response. As indicated in these comments, Canada 
would appreciate China's consideration of modifying the regulations to provid e 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 crypt ographic technical regulations; (iii) supporting the creation of 
equitable standards by indicating that all stakeholders can participate in the creation of commercial 
cryptographic standards; and (iv) indicating whether core and ordinary cryptography (as d efined in 
China's Cryptography Law) will, along with commercial cryptography, also be subject to new 
regulations. Furthermore, Canada would encourage China to notify the measure to the WTO TBT 
Committee, with a view to providing Members and stakeholders th e appropriate time to review and 
comment on the measure. Canada would also like to take this opportunity to note its ongoing 
concerns with China's Cryptography Law and its request that China: (i) define the scope of 
application in a way that ensures only l egitimate objectives pertaining to cryptographic goods would 
be pursued; and (ii) clarify that standards formulated pursuant to the law's provisions would be 
consistent with the TBT Agreement's transparency requirements.  
2.257.   In response, the representative of China  provided the following statement. Please see 
statement delivered under STC 294.54 
2.1.3.23   Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011), G/TBT/N/RUS/2  (ID 33255) 
2.258.   The representative of the European Union  provided the following statement. In 2012, the 
Russian Federation notified a draft technical regulation 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 a nd notify the revised text to the TBT Committee. The technical regulation 
also contains provisions covered by the Agreement on trade -related aspects of intellectual property 
rights. The EU would like to invite Russia to also notify the regulation to the Co uncil for TRIPS, as 
some of these 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. In particular, 
the EU would like to ensure that enriching wine with concentrated grape must or rectified 
concentrated grape must or sucrose to attain a higher alcohol co ntent level is an authorised practice 
for imported wines. The EU is concerned by the mandatory labelling requirements, which are not in 
 
54 Para. 2.103.    
55 For previous statements follow the thread under ID 332. G/TBT/M/83  
 
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  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. 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 po ints. This has to be 
clarified.  
2.259.   In view of these inconsistencies, the EU understands that the Russian authorities have 
postponed the entry into force of this measure by one year, and grant a transitional period to further 
discuss the standards and explore whether business operators can progressively adapt them. It 
appears that the discussion in Duma on the so -called Bakharev amendment to the Federal Law 
Nº 468 of 27.12.2019 on wine making and wine growing in the Russian Federation is delayed. Can 
the Russia n authorities inform if this delay would affect the timing of the amendment of the draft 
technical regulation on alcohol products safety? If yes, could you please inform when the final 
decision will be taken and formalized? The European Union would like to  ask Russia to take these 
comments into consideration and to renotify the new version of the measure, under the TBT 
agreement as well as under the TRIPS agreement.  
2.260.   In response, the representative of the Russian Federation  provided the following statement. 
The Technical Regulation has  been raised in this Committee many times and we commented on most 
of the arguments put forward today. Let me underline the main points that we made previously on 
this issue. The Technical Regulation was adopted in December 2018  and is planned to enter into 
force on the 1st of January 2022. The draft measure was notified back in 2012 as per Russia's 
obligations under the Agreement on TBT. There are no plans to renotify adopted text of the Technical 
Regulation in the TBT Committee . In case amendments to the Technical Regulation are developed, 
Russia will submit relevant notification. With regards to notification in the Council for TRIPS, as we 
stated previously multiple times, we fail to see grounds set out in Article 63 of the TRI PS Agreement 
for such notification of the Technical Regulation. 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 somethin g new for market players of the Russian alcohol market. 
Core aim of such requirements is to provide safe product to Russian consumers. Date of bottling and 
storage conditions labelling requirements are also not new requirements. They were introduced 
many y ears ago to avoid alcohol intoxication and fatal casualties among consumers. We would like 
to stress that this Technical Regulation contains no discriminatory provisions aimed to restrict trade.  
2.1.3.24   European Union - Draft Implementing Regulations amending Regu lation (EC) 
No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) No 
479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentation of certain wine sector pr oducts, 
G/TBT/N/EEC/264 , G/TBT/N/EEC/264 /Add.1 , G/TBT/N//EU/44 , G/TBT/N/EU/570 , 
G/TBT/N/EU/571  (ID 34556) 
2.261.   The representative of the United States  provided the following statement. European Union 
Regulation 2019/33 supplementing Regulation No 1308/2013 of the European Parliament and of the 
Council as regards applications for protection of designations of origin , geographical indications and 
traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to 
product specifications, cancellation of protection, and labelling and presentation (and its 
accompanying annexes) and Commissio n Implementing Regulation 2019/34 laying down the rules 
for the application of Regulation (EU) No 1308/2013 as regards applications for protection of 
designations of origin, geographical indications and traditional terms in the wine sector, the objection 
procedure, amendments to product specifications, the register of protected names, cancellation of 
protection and use of symbols, and of Regulation (EU) No 1306/2013 of the European Parliament 
and of the Council as regards an appropriate system of checks. It  is very disappointing that the 
United States must again raise its concerns with the EU's revisions to its draft regulation on 
geographical indications and traditional terms for wine; and specifically, our industry's pending 
applications for traditional te rms. The EU's persistent failure to provide any information leaves us no 
choice but to keep this item on the WTO TBT Committee's agenda, as well as the agenda of the WTO 
Council for Trade in Goods. Since the June 2018 TBT Committee meeting, the EU has been  saying 
that the pending applications for traditional terms were still under consideration, but that it could 
not provide a precise timeline for approval. Why is the EU still unable to provide any estimate or tell 
us where in the process these applications  are after nearly three years? What does the EU mean 
 
56 For previous statements follow the thread under ID 345. G/TBT/M/83  
 
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  when it says "under consideration? " Are they being actively considered, or have they been put on 
hold? If the applications have been put on hold, please explain why.  
2.262.   As we have indicated at each TBT Comm ittee since November 2019, 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, May, and October 2020 TBT 
Committee meetings,  please tell us the following: (i) how many applications for traditional terms 
have been lodged over the last ten years; (ii) how many of those applications have been approved, 
rejected, or remain pending; (iii9 what is the average time between application  and a final decision; 
(iv) for pending applications, how long have they been waiting; and (v) how many of the applications 
have come from member States? Can the EU confirm how the processing of these applications has 
changed, if at all, over the last two years following the adoption of Implementing Regulation 
2019/34? The United States has asked for clarification on this point during each TBT Committee 
meeting since November 2019 but has not received clarification from the EU.  
2.263.   We again thank the EU for it s response to our TBT comments, and clarification that our 
pending applications would not be subject to any new rules. However, several concerns remain, to 
include: Confirmation that US producers can continue to use any generic term, such as a grape 
variet y, that is part of a compound term protected as a GI by the EU. For example, US producers 
could still use the grape variety "Montepulciano, " even though the EU protects the compound name 
"Montepulciano d'Abruzzo. " How do third countries find out about amen ded changes with respect to 
EU Protected Designations of Origin (PDO) and Protected Geographical Indications? In its response 
to our TBT comments, the EU indicated that parties "… may submit an application to the Commission 
objecting to [an] application … within two months of the date of publication in the Official Journal of 
the European Union. " We would like to remind the EU of its obligations under Article 2.9 of the TBT 
Agreement to notify the WTO of these changes in draft form so that parties may comme nt through 
the formal WTO process. What is the definition of "generic? " This question was not addressed in the 
EU's response to our TBT comments. Lastly, we continue to seek confirmation that the revised 
regulation will not alter the ability of US producer s to use terms such as "barrel aged " as provided 
for in Appendix II of the Protocol on Labelling to the 2006 U.S./EU Wine Agreement. In its response 
to our TBT comments, the EU indicated that "consumers' expectations have been taken into account 
by reservi ng some labelling particulars concerning specific production methods. " Based on this 
response, we remain unsure if the term "barrel aged " can still be used and ask that the EU please 
clarify.  
2.264.   The representative of Brazil  provided the following statement. B razil would like to support 
the concerns raised by the US and refers 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. 607/200 9 and Council Regulation (EC) No 479/2008.  
2.265.   The representative of New Zealand  provided the following statement. We refer the European 
Union to New Zealand's statement on this trade concern made at preceding TBT Committees, most 
recently in October 2020: New  Zealand recognizes that Members have the right to protect their 
consumers from deceptive practices in line with their obligations under the World Trade Organization. 
New Zealand asks that the European Union takes into consideration concerns raised by Memb ers 
relating to the scope and application of the system of traditional terms, as well as transparency, 
process, and timelines relating to applications by third countries who wish to use traditional terms 
in the European Union.  
2.266.   The representative of Argenti na provided the following statement. We thank the United 
States for including this specific trade concern (STC) on the Committee's agenda.  Argentina 
reiterates concerns expressed at previous meetings of this Committee regarding the discrimination 
suffered by national wines, which are prevented from using the traditional terms "Reserva" and 
"Gran Reserva" on their labels, even though our country completed the substantive procedure to 
approve such terms in March  2012 under EU Law. We once 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.  
2.267.   In response, the repres entative 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 G/TBT/M/83  
 
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  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 transparent 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 or via bilateral 
agreements.  
2.1.3.25   India - Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IND/44 , G/TBT/N/IND/44/Add.1 , 
G/TBT/N/IND/44/Add.2 , G/TBT/N/IND/44/Add.3 , G/TBT/N/IND/44/Add.4 , 
G/TBT/N/IND/44/Add .5 G/TBT/N/IND/4 4/Add.6 , G/TBT/N /IND/44/Add.7 , 
G/TBT/N/IND/4 7,  G/TBT/N/IND/47/Add.1 , G/TBT/N/IND/47/Add.1/Corr.1 , 
G/TBT/N/IND/47/Add.2 , G/TBT/N/IND/47/Add.3 , G/TBT/N/IND/58  (ID 36757) 
2.268.   The representative of the United States  provided the  following statement. We understand 
that on 1 October 2020 the Ministry of Electronics and Information Technology (MeitY) published 
Phase V of the Electronics and Information Technology Goods (Requirements for Compulsory 
Registration) Order (CRO), effectiv e 1 April 2021, which expands the CRO requirements to include 
seven additional product categories, including digital cameras, video cameras, Bluetooth speakers, 
and smart speakers. While we appreciate MeitY's provision of six months for US industry to comp ly 
with Phase V of the CRO, we note that this timeframe is insufficient because India has yet to provide 
the necessary resources and guidance for compliance, namely: 1) product series guidelines and 
FAQs from MeitY; 2) the new Test Report Format from the B ureau of Indian Standards (BIS); 3) a 
BIS portal for submitting applications; 4) and laboratories that are accredited by BIS and ready to 
accept products for testing. According to US industry, without these necessary resources and 
guidance, it will be impo ssible to fully comply with the CRO's registration requirements within the 
allotted timeframe. With respect to Phase V and all future Phases, we ask that MeitY provide a 
transition period of at least one year from the date on which all four of the necessar y resources and 
guidance listed above have been made available. We also understand that US industry has expressed 
concerns regarding how the scope of Phase V appears to be based on HS codes rather than individual 
products, potentially including a wider sco pe of products than intended. Specifically, we note that 
Phase V includes the product categories "digital cameras " and "video cameras. " We encourage MeitY 
to instead consider categorizing these cameras based on their end use, e.g. professional cameras or 
security cameras, to accurately refine the Phase V scope. The United States also understands that, 
beginning in the spring of 2020, Indian authorities began requiring final application approval by 
MeitY after BIS approval. This added requirement has extende d the review process from four weeks 
to six -nine weeks. According to US industry, India did not provide any notice concerning this added 
requirement or its impact on the anticipated processing period. We ask that India provide greater 
transparency when int roducing changes to its review process to ensure that the process does not 
have the effect of creating unnecessary obstacles to international trade and that applicants are aware 
of the anticipated processing period, especially ahead of major sales seasons.  
2.269.   The representative of Canada  provided the following statement. Canada would like to 
reiterate longstanding concerns raised by Canada and other WTO Members regarding the 
Compulsory Registration Order since 2012, and which can be summarized as follows: (i) high cost 
for operators associated with mandatory testing in India; (ii) requirement that product testing be 
done only by Bureau of Indian Standards -accredited labs located within India; (iii) Order does not 
allow for the use of international standards; an d (iv) the failure on BIS's part to recognize test results 
from internationally accredited labs. Canada continues to urge India to adopt IEC standards and to 
recognize test results from internationally accredited labs.  
2.270.   In response, the representative of India provided the following statement. MeitY has notified 
seven product categories under phase V Electronics and Information Technology Goods 
(Requirements for Compulsory Registration) Order (CRO) on 1 October 2020, scheduled to be 
effective from 1 April 20 21. The series guidelines and test report formats for product categories 
notified under CRO Phase -V are available in the public domain at 
https://www.meity.gov.in/esdm/standards  and https://bis.gov.in/index.php/laboratorys/utrf , 
respectively. FAQs just provide clarification to the queries of the industry. The product categories 
are notified under CRO irrespective of their HS codes. The digital and video cameras are separate 
product categories. It would not be feasible to categorize the products according to their end use. 
 
57 For previous statements follow the thread under ID 367. G/TBT/M/83  
 
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  The same product may have different end -uses. For concerns of Canada: The testing charges are 
market -driven. The Compulsory Registration Scheme (CRS) as laid down requires testing to be 
conducted at BIS -recognized labs. There is no requirement for in -country testing in the notification. 
There is a provision for overseas labs also to seek recognition from BIS b ased on the qualification 
criteria. The sample of the notified goods must be tested from any laboratory recognized by the BIS 
or any laboratory abroad covered under a mutual recognition agreement with the Bureau. Indian 
standards regulated under Compulsory  Registration Order (CRO) are harmonized with or based on 
relevant international standards. Components certified under the IECEE CB Scheme are being 
accepted for the purpose of product approvals under the CRS.  
2.1.3.26   China - Registration Fees for Drugs and Medica l Device Products (ID 46658) 
2.271.   The representative of the Republic of Korea  provided the following statement. Korea has 
continuously raised concerns on China's Registration Fees for Drugs and Medical Devices through 
bilateral and multilateral channels and wou ld like to refer to our statements made during the last 
meeting. Korea wishes to request China to take into account Korea's comments on the revision of 
the Charging Standards for Drug and Medical Device Registration from 2015.  
2.272.   In response, the representati ve 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 were 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 
determined by the cost of the conformity assessment works. The minor difference of the registration 
fees is due to different workload and price level.  
2.1.3.27   Indonesia - Halal Product Assurance Law No. 33 of 2014, G/TBT/N/IDN/123 , 
G/TBT/N/IDN/131  (ID 50259) 
2.273.   The representative of the European Union  provided the following statement. The EU thanks 
Indonesia for a fruitful bi lateral meeting. The European Union reiterates 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 pr oducts to be 
placed on the Indonesian market, implying strong repercussions and difficulties in EU trade with 
Indonesia. The EU regrets that, contrary to Article 2.9 of the TBT Agreement, Indonesia failed to 
notify to the TBT Committee the Halal Product Gu arantee Law and Implementing Regulation No 
31/2019. Indonesia notified Implementing Regulation 26/2019 on the Facilitation of Halal Product 
Assurance and Regulation 31/2018 on Processed Food Labelling to the TBT Committee and the EU 
invites Indonesia to re ply to its comments of 27 April and 12 May 2020. The EU acknowledges the 
recent notification to the TBT Committee of a draft Government Regulation (RPP) on Halal Product 
Assurance implementing the Omnibus Bill on Job Creation (Law 11/2020). The EU stresses  the 
excessive restrictive impact on trade of the 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 informat ion. Among the main issues of concern, we can 
mention the "non-Halal" information requested for non -Halal products or the extension of Halal 
requirements to products other than food and beverages. In particular, the need for a government -
to-government arra ngement as a pre -condition for recognition of foreign Halal certificates represents 
an excessive burden for economic operators and does not facilitate trade. The EU appreciates some 
flexibility from Indonesia on this issue. The additional registration requ irement for Halal certifications 
by foreign bodies appears unjustified, costly and duplicative. The EU insists that Indonesia accepts 
test reports from EU laboratories accredited by a body member of the international arrangements 
for mutual recognition of the International Laboratory Accreditation Cooperation (ILAC) and the 
International Accreditation Forum (IAF). The EU calls Indonesia to consider less restrictive measures 
and to inform Members on the status of Halal implementing provisions. The EU indicat es its 
willingness to further discuss and cooperate on Halal issues with Indonesia, with the aim of finding 
a practical way forward and to resolve concerns.  
2.274.   The representative of Australia  provided the following statement. Australia welcomes 
ongoing discus sions on the Indonesian Halal Product Assurance Law no.33 of 2014 (Halal Law) and 
 
58 For previous statements follow the thread under ID 466. 
59 For previous statements follow the thread under ID 502. G/TBT/M/83  
 
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  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 facilitat e an open dialogue 
with trading partners to allow foreign businesses and their valued Indonesian importers to remain 
adequately informed of Halal Law implementation regulations. Australia welcomes further dialogue 
on the Halal Law to ensure its implementat ion is no more trade restrictive than necessary.  
2.275.   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 the recent notifications of a new draft implementing 
regulation for the Halal Law, submitted to the Committee as G/TBT/N/IDN/131 . We hope all 
comments submitted to this notification are taken into consideration as the regulation is finalized. 
We under stand that Indonesia finalized and issued: (i) Government Regulation 31 of 2019 in May 
2019 on "Implementation Provisions of Law 33/2014 regarding Halal Product Assurance " related to 
the Halal Law; and (ii) Ministry of Religious Affairs (MORA) Decree no. 4 64, a positive list for products 
requiring halal certification. We ask that Indonesia notify these measures and any additional 
implementing measures to the Committee. We understand that the Halal Product Assurance Agency 
is starting to develop implementing  measures and guidance for specific product categories. We ask 
that Indonesia specify the process and timeline for notifying and soliciting public comment on the 
implementing measures regarding the certification, packaging, and labelling requirements for 
specific product categories. 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 impleme ntation of mandatory Halal 
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?  
2.276.   We also await  clarification about the status of proposed legislation connected with "Medicinal 
product, biological product and medical equipment made from non -Halal raw material or non -Halal 
processing, " as listed in the notification to this Committee. We understand th at on 5 October 2020, 
Indonesia finalized an Omnibus Job Creation Bill that modifies the original Halal Law. How does the 
Omnibus Job Creation Bill modify the original Halal Law? We request further information regarding 
Indonesia's response to US Governmen t 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 referenced in Indonesia's 
response? In vie w of these regulations, are manufacturers of products and ingredients that contain 
denatured alcohol required to label such products and ingredients as haram as specified in 
Indonesian Ulema Council (MUI) Fatwa 11 of 2009? Will the requirements for non -Halal labels be 
applied equally to both imported and domestically manufactured products? We also ask that the 
aforementioned BPOM/NADFC regulations for cosmetics be notified for comment, if they will result 
in new labelling requirements for US cosmetics impor ted into Indonesia. We ask that Indonesia 
consider the industry and US Government comments submitted expressing concerns as to the 
feasibility and necessity of requiring that all categories of covered products have separate Halal 
versus non -Halal manufactu ring, processing, storage, packaging, and distribution facilities. Did the 
January 2021 draft implementing regulation of the Halal Law exclude the requirement for separate 
sales facilities for Halal versus haram products?  
2.277.   We remain concerned by Indonesia's  explanation at the February 2020 TBT Committee 
meeting that 'naturally Halal' food and beverage products considered exempt from the new Halal 
Law did not include fresh fruits and vegetables that had been frozen. Can Indonesia explain why the 
process of fr eezing would require a Halal certification? Further, we continue to seek clarity on the 
status of bulk shipments. We are also concerned about the inclusion of genetically engineered (GE) 
products on the list of products requiring certification under the MO RA Decree no. 464. Could 
Indonesia provide its justification for requiring the certification of GE products? Previously, the MUI 
issued Fatwa 35/2013, which declares that GE products are Halal provided that they are useful and 
do not cause harm. The United  States notes that requiring certification of GE products could cause 
trade disruptions and adversely impact Indonesia's textile and livestock industries that utilize US GE 
commodities, such as soybeans and cotton. Therefore, the United States requests the  removal of 
GE products from the list of products requiring halal certification in Decree no. 464. We would like 
to thank Indonesia for 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 started the application process G/TBT/M/83  
 
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  to renew recognition of their Halal certifications, they have received only minimal feedback on their 
applications. It is unclear whether their current recognition in Indonesia will expire immediately upon 
the MORA implementing regulation's enactment, or whether a grace period for the application 
process will be provided. Can Indonesia provide cla rity on the application status of the US -based 
Halal certifiers, and whether a grace period will be provided that will allow the continuation of imports 
during the application process? Does the January 2021 draft implementing regulation of the Halal 
Law ex tend this recognition to other products these certification bodies cover, including cosmetics?  
2.278.   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 Indonesia remove or modify this requirement to 
reflect the fact that Indonesia's Halal Product Assurance Agency (BPJPH) already conducts 
verification audits of those foreig n Halal certification bodies. We ask that Indonesia provide greater 
specificity as to which medical devices will be subject to the Halal Law's implementing regulations. 
We also ask Indonesia to clarify their response to the US medical device industry's Dec ember 2019 
letter 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 that are not subsequently returned 
to the human body. Would you confirm that ha ram (non -Halal) vaccines will be permitted as long 
as there is no equivalent Halal vaccine available for the same medical condition with comparable 
safety, efficacy, and quality profiles? What will the process be to ensure this? We are encouraged by 
Indone sia'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 tra nsition time, and an opportunity 
for stakeholder comments.  
2.279.   The representative of Canada  provided the following statement. Canada would like to thank 
Indonesia for its continued engagement on this issue. However, a number of concerns pertaining to 
the law a re still outstanding and we would appreciate further clarification from Indonesia on 
implementing regulations. 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. As this 
would be beneficial to importers, we would appreciate if Indonesia could inform whether this 
specification will be included in the forthcoming implementing regulations for the Halal Product 
Assurance Law. However, concerns rema in with the requirement that non -Halal products must 
include non -Halal information in the form of "pictures, signs, or writing" as this may be overly 
burdensome and restrict mutually beneficial commerce. In Canada's view, products that do not 
display a Hal al certification can be safely assumed to be non -Halal. We look forward to further 
constructive dialogue on other outstanding issues, including the Halal certification requirements for 
single -ingredient frozen foods, accreditation requirements for certific ation bodies accredited by a 
third-party accreditor and discussions on further implementing regulations. Any information 
Indonesia is able to share on the expected timelines for the pending implementation regulations of 
the Halal Product Assurance Law woul d be most welcome. This will help Canadian producers comply 
with the new law and allow trading partners to comment and seek the necessary clarifications.  
2.280.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank In donesia for its ongoing engagement to date regarding this matter. In reference to 
the response Indonesia provided in the previous committee New Zealand continues to seek further 
guidance on the timeframe for release of the ministerial decree that will stip ulate the type of products 
that must be Halal certified. We ask for some clarity on the status of Halal Certification Organisations 
whose certification will soon expire or has already expired with MUI, and whether there are any 
transitory arrangements in p lace 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 development, in 
addition to the Minister of Religious Affairs' regulation noted in your response. We understand that 
the Halal certification fees will need to be set in a Ministry of Finance regulation, and welcome any 
further clarification on this. We also understand that the 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.  
2.281.   In response, the representative  of Indonesia  provided the following statement. Indonesia 
would like to refer to its statement on the last TBT meeting on October. Indonesia is aware of its 
transparency obligations as mandated in the TBT Agreement. Thus, Indonesia has notified draft 
Regul ation of Minister of Religion Affairs through document G/TBT/N/IDN/123  as one of th e G/TBT/M/83  
 
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  implementing provisions of Halal Law. However, the status of this provision is yet to be enforced as 
the draft is still being reviewed. Recently, Indonesia has also notified draft of Government Regulation 
regarding Implementation of Halal Product Assuran ces as the implementing provisions of Halal Law 
in document G/TBT/N/IDN/131 . This aforementioned regulation will revoke Government Regulation 
No. 31/2019. Indonesia would like to reiterate its openness to international cooperation with foreign 
Halal institutions or authorities. Coo peration with foreign Halal institutions will prioritize the principle 
of mutual recognition and mutual acceptance in accordance with international regulations and 
practices.  
2.1.3.28   Russian Federation - Rules of cement certification, G/TBT/N/RUS/48 , 
G/TBT/N/RUS/49  (ID 49760) 
2.282.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its previous statements in the TBT Committee on this issue. 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, despi te 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 force. Since the introductio n 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 entry 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 would be notified to the W TO at a draft stage, in line with the rules 
set out by the TBT Agreement. Given the lack of notification to this day, as well as the explanations 
provided by the Russian Federation during the last TBT Committee meeting, referring to delays 
caused by the CO VID-19 pandemic, 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.  
2.283.   In response, the representative of the Russian Feder ation provided the following statement.  
As the issue has been considered multiple times in this forum, we refer to our previous statements 
and have nothing new to report.  
2.1.3.29   India - Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulations, 2015, G/TBT/N/IND/51 , G/TBT/N/IND/104  (ID 49461) 
2.284.   The r epresentative of the European Union  provided the following statement. The EU would 
like to reiterate some remaining concerns regarding this measure. We took note of the new 
amendment regarding alcoholic beverages that was published on 18 December 2020 and will apply 
as from 1 July 2021. Several of our concerns for wine have been taken into account and an alignment 
to OIV standards took place for large parts. This is a large step in the right direction. There remain 
however some issues, described in EU comme nts on G/TBT/N/IND/104 , for which we would welcome 
a reply. We 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 -exhaustion clause 
(to allow the sale of products already present on the Indian market until stocks are exhausted in 
order to minimise the impact for economic operators) and transition period. The presence of some 
technical specifications (the maximum alcohol content, some spirits definitions) that may no t be in 
line with international widely accepted practices and could result in an adverse impact for 
international trade. We hope that we can continue our discussion and find an acceptable solution to 
the outstanding issues.  
2.285.   The representative of Mexico  provided the following statement. We thank the European 
Union for including this matter and share the concerns expressed . For the delegation of Mexico, the 
amended version gives rise to the following concerns:  The limitation of percentage alcohol by volume 
(ABV) in all categories to a maximum of  50% ABV restricts the importation and sale of barrel -aged 
whiskies and premium expressions. The minimum alcohol content for aperitifs, currently set at 15%, 
is also limiting.  The analytical parameters that are establis hed for a number of categories and that 
do not exist in other countries.  Definitions that are inconsistent with international practices and 
 
60 For previous statements follow the thread under ID 497. 
61 For previous statements follow the thread under ID 494. G/TBT/M/83  
 
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  national standards.  The requirement that all beverages produced in pot stills must include the 
description "Pot -Distilled" on the back label. There is no such requirement in Mexico and it will lead 
to an unnecessary and costly adjustment of labels for various categories of alcoholic beverages.  
Requirements relating to the duration of the maturation process, which does n ot reflect the fact that 
the time required for a product or ingredient to mature to obtain a certain flavour depends on the 
type of product and cannot be laid down by a generic provision.  In light of the above, Mexico would 
appreciate information on the st atus of this regulation and on whether it is possible to extend the 
time period for its entry into force until July  2022.  We thank India for giving its attention to this 
statement and for the response to the concerns raised.  
2.286.   In response, the representative  of India provided the following statement. The majority of 
the standards prescribed in the FSSAI Alcoholic Beverages Regulations, 2018, have been aligned 
with OIV in line with WTO commitments. The issues highlighted have been discussed several times 
in Scientific Panel meetings on Alcoholic Beverages and the alcohol content, sugar content, etc., 
have been established after extensive deliberations. In addition to this, alignment of the methods of 
analysis of alcoholic beverages with the OIV is under process . 
2.1.3.30   Egypt - Manufacturer Registration System (Decree No. 43/2016 and Decree No. 
992/2015) ,  G/TBT/N/EGY/114 , G/TBT/N/EGY/115  (ID 50562) 
2.287.   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. The EU calls on Egypt to immediately register all EU companies that have 
updated or will update their quality certificates, wi thout discrimination in relation to the sectors of 
their activity and without the need of restarting the application process. The EU reiterates 
furthermore 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, lack of a clear appeal 
procedure, and a high level of discretion in granting registrations. As such, the measure raises 
questions of compatibility with the WTO TBT Agreement. The EU would there fore 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.  
2.288.   The represen tative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates the statements made during the previous meetings of the Committee on 
Technical Barriers to Trade and the Council for Trade in Goods on the Egyptian registr ation 
procedures under the Decree № 43/2016. The registration procedure is burdensome, time 
consuming, untransparent and represents discriminative barrier for trade. Companies that provided 
full set of documents for registration to Egypt's authorities have  been denied market access for years 
without providing proper reasons. We question the consistency of the measure with Egypt's 
obligations under, inter alia , Articles 5.1 and 5.2 of the Agreement on Technical Barriers to Trade, 
Article I, III and XI of GAT T 1994. We request Egypt to reconsider this registration system and 
ensure its compliance with the rules of this organization.  
2.289.   The representative of Turkey  provided the following statement. Turkey would like to thank 
Egypt for constructive engagement on th is issue. However, we join the EU and Russian Federation 
to emphasize our ongoing concerns on Egypt's Decree on manufacturer registration system, as the 
structural problems related to this Decree and implementation still continue. In this regard, it is sti ll 
unclear how the applications are evaluated, whether the completion of the process is subject to any 
time limits and which steps should be followed to complete a registration process. In addition, 
companies are not informed on the status of their applica tion and no notification is made to 
companies whether their application is approved or not. Expectedly, companies face long delays and 
bear additional costs in the registration process. Therefore, Turkey would like to reiterate its 
expectations from Egypt to review this measure considering the principles and obligations in the 
WTO Agreements and ensure its implementation in full transparency.  
2.290.   In response, the representative of Egypt  provided the following statement. We thank the 
European Union and Russia fo r maintaining this item on the agenda, and we would also like to 
express our appreciation for the bilateral exchanges we have had with a couple of delegations in this 
 
62 For previous statements follow the thread under ID 505. G/TBT/M/83  
 
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  respect. We will refrain from repeating the points raised in previous statements concerni ng the 
rationale and administration of Decree 43/2016. Instead, we will focus our intervention today on the 
steps undertaken to enhance the transparency of the Decree implementation. Starting last year, and 
due to demands by some WTO Members, Egypt's Gener al Organization for Export and Import Control 
(GOEIC) has commenced to publish via its official website lists of the companies whose registration 
was suspended due to documentation issues, as well as those who are in need to renew the required 
certificates  to avoid the registration process re -initiation, granting them grace periods for the 
certification renewal. Earlier this year, GOEIC published a list of companies whose applications have 
been pending due to the need for valid documents, granting them a gr ace period from 17 January 
until 28 February 2021, and we invite Members with pending companies' applications to consult this 
list. 
2.291.   Moreover, in previous committee meetings a couple of Members expressed concern over the 
publication of the aforementioned li sts in Arabic only, and in this vein GOEIC has started to share 
an English translation to the published Arabic lists for the sake of facilitating and accelerating the 
access to such information. And finally, a number of exchanges have recently taken place on the 
level of capitals or via Members' embassies in Cairo, both to acquire the needed clarifications and to 
address company -specific problems. It is worth highlighting that transparency enhancement efforts 
have been slowed down and hindered by the COVID -19 pandemic and the subsequent containment 
measures that complicated further the coordination process among the concerned governmental 
authorities. To conclude, we renew our invitation to the concerned Members to reach out to us both 
on the level of perman ent missions as well as capitals to address the specific problems facing 
companies with regard to the registration process.  
2.1.3.31   China - Cybersecurity Law (ID 52663) 
2.292.   The representative of the European Union  provided the following statement. The EU would 
like to  refer to its comments at 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 regardin g several of the implementing 
measures of 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 as to what is considered as  critical information infrastructure and which kinds of cross -
border data transfers are affected. The definition of critical information infrastructure appears to 
cover many commercial activities and whole sectors that have no connection to national securi ty. 
Additionally, the list of what is considered important data is open -ended and this has not been further 
clarified by the released draft for the Data Security Law in July 2020. As a result of the data 
localisation and security assessment requirements, f oreign companies operating in China could find 
themselves in a less competitive situation compared to domestic operators. The EU calls on China 
to implement the provisions in a non -discriminatory manner, respecting the principles of 
proportionality, necess ity and technology neutrality, and ensuring adequate protection of intellectual 
property (IP). Furthermore, the EU would like to repeat its previous requests for clarifications on the 
relationship with existing Multi -Level Protection Schemes and the expect ed implementation timeline. 
The EU requests that China notifies draft measures concerning any sectoral implementation to the 
WTO in order to give adequate opportunity to Members and their stakeholders to comment on any 
subsequent developments.  
2.293.   The represen tative of Japan  provided the following statement. Japan continues to have 
concerns regarding the China's "Cybersecurity Law " and would like to refer to the previous statement 
we made at the last TBT Committee in October 2020. Japan is concerned with the re lated 
enforcement regulation as well. Japan would like to request that China provide notification of the 
enforcement regulations to the TBT Committee and consider comments from stakeholders. In 
addition, Japan would like to request that China provide adequ ate lead time from completion of these 
regulations until their enforcement, and to implement these measures in a transparent manner.  
2.294.   The representative of Australia  provided the following statement. Australia appreciates 
China's efforts to consult with int erested parties on its measures relating to cybersecurity, including 
China's recent public consultation on its draft Personal Information Protection Law, on which 
Australia made a submission in November 2020. Australia reiterates our previous position rega rding 
China's Cybersecurity Law and related laws. Australia respectfully reiterates our concerns that some 
 
63 For previous statements follow the thread under ID 526. G/TBT/M/83  
 
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  details of these laws remain unclear. Australia notes that, consistent with the TBT Agreement, the 
measures should be implemented in a non -discrimina tory manner and in a way that is no more trade 
restrictive than necessary. Australia urges China to consider less trade -restrictive measures that are 
reasonably available to achieve its objectives.  
2.295.   The representative of the United 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 comm ercial sectors. 
China's Cybersecurity Law entered into force on 1 June 2017, in spite of serious and long -standing 
concerns from the United States and many other international stakeholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
sometime general in scope, and sometimes sector -specific. We have many concerns regarding 
China's Cybersecurity Law and related measures, which impose far -reaching, highly trade restrictive 
conditions on fore ign 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 Multi -Level Protection Scheme (MLPS) . 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 pr ior interventions by the United States and other 
Members at prior Committee meetings.  
2.296.   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 concern ed that 
this law codifies 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 w idespread 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 request that China afford subsequent opportunities 
for interested parties to submit comments on revised iterations of draft standards and all other 
implementing measures related to the Cybersecurity Law. Given the broad potential impact of these 
standards and measures and the serious concerns they have raised, it is crit ical that China act 
deliberately to collaborate with all interested parties, and take their comments into account before 
adopting the drafts as written. We will continue to carefully monitor China's implementation of the 
Cybersecurity law and related measu res, as well as the Cryptography Law. We look forward to 
continuing this important dialogue with you.  
2.297.   The representative  of Canada  provided the following statement. Canada echoes comments 
made  by previous Members and reiterates concerns made in previous me etings.  
2.298.   In response, the representative of China  provided the following statement. The 
"Cybersecurity Law" has been implemented since 1 June 2017. It is a basic, framework and 
comprehensive law in the field of cybersecurity in China. It clarifies the respo nsibilities and 
obligations of all aspects in safeguarding cybersecurity, and puts forward a series of institutional 
arrangements and key tasks. Since the implementation of the cybersecurity law, it has played an 
important role in safeguarding the national  cyber security. Drawing on international practices, in 
response to national conditions, it is entirely within the sovereignty of each Member to formulate 
relevant network laws and administrative regulations and manage the network according to law. The 
purpose of enacting and implementing the cybersecurity law is to safeguard the national cyberspace 
sovereignty, national security, social and public interests, and to protect the rights and interests of 
citizens, legal persons and other organizations. "Cybers ecurity Law" is a law to promote development 
and opening up, that is, to be based on opening up and globalization to safeguard national cyber 
security. China welcomes enterprises from all over the world to invest in China, welcome all kinds 
of products and  services to enter Chinese market, taking the opportunities and sharing the 
development benefits.  G/TBT/M/83  
 
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  2.1.3.32   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629  (ID 53964) 
2.299.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statements made during the previous regular meetings of the Committee 
on Technical Barriers to Trade and the Council for Trade in Goods on cobalt classification approved 
under the 14t h Adaptation to Technical Progress to the CLP Regulation and notified in the document 
G/TBT/N/EU/629 . The EU adopted this classification in the absence of comprehensive scientific and 
epidemiological data. Based on this classification, it is clear that the European Commission will go  
further and develop industrial, product -specific and technical regulations, which will set unjustified 
restrictions or prohibit cobalt use. Moreover, as a result of stigmatization, even without further 
restrictions cobalt and cobalt -containing products co nsumption will suffer due to deselection of these 
products by manufacturers of the final goods, such as, electric vehicles' batteries, energy storage 
units and similar equipment critical to fight the climate change and achieve green sustainability.  
Althoug h we welcome European Commission's efforts to approve gastric bioelution, we note that 
this methodology has not been approved yet. In this regard, could the EU inform the Committee on 
the state of work on bioelution?  Finally, the Cobalt Institute completed  all the formal procedures 
under the legislation of the European Union to initiate scientific study on carcinogenicity of cobalt 
metal for oral route of exposure. In this regard, we request the European Union to confirm that 
adopted cobalt classification f or all routes of exposure will be reconsidered in case of shown negative 
carcinogenicity of this metal for oral route of exposure.  
2.300.   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 reclassification of cobalt as a 
carcinogenic level 1B was approved. The classification of cobalt as a carcinogenic product generates 
a great potential negative impact on nickel production in Brazil since cobalt is also found in trace 
amounts within nickel production. Restrictions on cobalt trade would therefore negatively affect 
nickel production in Brazil. From 1 October 2021, cobalt m etal will no longer be allowed to be placed 
on the market on its own or in alloys (above the concentration limits in Table 3 below) for supply to 
the general public and must be labelled as "Restricted to professional users". Brazil is the primary 
nickel -producing country in South America, exporting around 70 thousand tonnes of nickel, 
according to 2017 figures. According to industry estimates for the same year, the total value of 
nickel production reaches US$12.350 million. Around 56% of the nickel mine pro duction in Brazil is 
at risk with limitations on the trade of cobalt. In light of this concern, we kindly ask the EU to consider 
revising restrictions on the use of cobalt, while relying on sound scientific analyses to support its 
technical regulations wit h a significant impact on trade.  
2.301.   The representative of Australia  provided the following statement. Australia would again like 
to support this 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. Australia and other WTO Members have raised concerns on 
multiple occasions in this and other forums that these measures remain more trade -restrictive than 
necessary. Our concerns have focused on the potential of these regulations to create unnecessary 
obstacles to international trade in products containing t itanium dioxide and cobalt, as well as the 
related raw materials. Noting that this regulation has been adopted, and will apply from October 
2021, we once more urge the EU to ensure that the implementation of the regulation, including 
associated labelling a nd packaging requirements raised in October, are no more trade restrictive 
than necessary. We again also urge the EU to ensure that the implementation of these measures 
has the least possible impact on downstream products containing titanium dioxide and co balt 
(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 increasing ly used in battery technology. There are remaining 
concerns among the Australian chemical, cosmetic, medicament, paint and resources sectors.  
2.302.   We welcome a further response to our 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. Further, 
while we welcomed the final EU classification being limited to mixtures contai ning titanium dioxide 
 
64 For previous statements follow the thread under ID 539. G/TBT/M/83  
 
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  that are placed on the market in powder form (with a diameter smaller than 10 μm), there remains 
some confusion from Australian industry around the requirements for products that contain titanium 
dioxide in a non -powdered form (for ex ample in paint, complementary medicines, and sunscreens). 
For liquid mixture products, there is still an obligation to update labels with a warning that could 
have detrimental reputational and trade impacts.  
2.303.   In response, the representative of the European Union  provided the following statement. 
The Commission Delegated Regulation amending the CLP Regulation was published in the Official 
Journal of the EU in the beginning of 2020 and the classification of cobalt will become applicable as 
of 1 October 2021. T he 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 membe r 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 WTO Members 
were distributed to member States and they were dul y 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 determine the Specific Concentration Limit of 
0.01% should be asse ssed 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 limit of 0.1% will therefore be applied. The EU would like to re iterate 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 considerations are not part of the principles for hazard 
classificat ion. 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 
harmonised 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).  
2.304.   As also mentioned in reply of 23 September 2020 to the letter 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 method. 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 relative 
in vitro  bioaccessibility of metals and metalloids in inorganic metal compounds and metal 
(metalloids) -containing materials using a simulated gastric fluid. 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 gu ideline. 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 has been set up to work on the 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 classi fication 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 t his 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 States and metal industries. The first meeting of this group took pla ce in September 2020, 
and further meetings of the group will take place to achieve the goals described above.  
2.305.   With regard to the classification of cobalt as carcinogen for all routes of exposure, including 
the oral route, the EU would like to reiterate tha t 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 route of exposure if it is conclusively proven that no other routes 
of exposure cause the hazard ". In the case of cobalt, such evidence was not available, i.e. the 
scientific data available were not sufficient to conclusively exclude that the oral route of exposure 
causes the hazard. A potential re -examination of the classi fication 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 dermal routes of exposure, become available. In view 
of the time nee ded for such test results to become available, there was no scientific and legal G/TBT/M/83  
 
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  justification to exclude the oral route. In case new scientific information becomes available in the 
future, an amendment could only be envisaged following a revised Risk Asse ssment Committee 
(RAC) opinion.  
2.1.3.33   European Union - Organic production and labelling - Maté (erva -mate), 
G/TBT/N/EU/738  (ID 52465) 
2.306.   The representative of Brazil  provided the following statement. Brazil regrets having to raise 
STC 524 after being consistently reassured by the EU that Regu lation (EU) 2018/848 would come to 
force on January 1st, 2021. Brazil had raised this STC for the last time in the TBT meeting of 
November 2019, in which the European Union stressed that erva -mate was not within the scope of 
the current organic Regulation (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 
Parliame nt and the Council included Maté under its scope. 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 ce rtain other dates 
(G/TBT/N/EU/738). Following its adoption, instead of entering into force on 1 January 2021, 
Regulation (EU) 2018 /848 will now enter into application on 1 January 2022. The postponement of 
the entry into force of Regulation (EU) 2018/848 s hows 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 a nd more trade -restrictive than necessary, 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 los ses are not 
expected to meet any sort of compensation. Brazil kindly asks the EU if it intends to once again put 
off the entry into force of said regulation.  
2.307.   In response, the representative of the European Union  provided the following statement. 55 
The Eur opean Union reiterates that it has replied to Brazil on this issue in previous TBT Committee 
meetings, as well as bilaterally. As previously explained, Erva-Mate is  not within the scope of the 
current EU Regulation on organics (Regulation (EC) 834/2007) an d there is no possibility to modify 
this. The new Regulation (EU) 2018/848 on organic production 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 ente r into application on 1 January 2021. Nevertheless, following 
the on -going COVID -19 crisis, the organic sector needed additional time to adapt to the new rules 
on production, controls and trade. The EU notified to the TBT Committee a draft Regulation, for 
adoption and publication before the end of 2021, postponing the entry into application of the organics 
Regulation by one year ( G/TBT/N/EU/738 ). As explained by the EU in its reply of 5 January 2021 to 
Brazil's written comments, the new organic rules will enter into application on 1 J anuary 2022. From 
this date, Erva -Mate will be included in the scope of Regulation (EU) 2018/848, as it is listed in 
Annex I as a product closely linked to agriculture.  
2.1.3.34   China - Catalogue of Solid Wastes Forbidden to Import into China, 
G/TBT/N/CHN/1211  (ID 54566) 
2.308.   The representativ e of New Zealand  provided the following statement. New Zealand 
acknowledges and supports the right of all WTO Members to regulate to achieve legitimate domestic 
health and environmental objectives. New Zealand applauds China's stated proactive policy 
objec tives 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. Howe ver, New Zealand remains 
concerned that vanadium slag is included in China's catalogue of banned imports under this measure. 
We reiterate our view that vanadium slag is a purposefully produced co -product with a purposeful 
end use in production of specific forms of steel. It is not a waste product, and so should not fall 
under measures for solid waste. New Zealand understands that China itself is the largest global 
producer of vanadium slag, and that its production has reportedly increased over 30 percent si nce 
2018. 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 
 
65 For previous statements follow the thread under ID 524. 
66 For previous statements follow the thread under ID 545. G/TBT/M/83  
 
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  interested also to hear a further explanation from Chin a on how it has ensured that the import ban 
on vanadium slag is not more trade restrictive than necessary to achieve China's environmental and 
health protection objectives. New 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 distinguishing between waste and non -waste materials.  
2.309.   The representative of Canada  provided the following statement.  Canada would like 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 March 2018 regarding the inclusion of wood pellets for energy production 
on the list of banned waste products. As we previously noted, Canada does not wish t o dispute 
China's willingness to protect the environment, including by limiting harmful impacts resulting from 
contaminated waste material. Canadian wood pellets, however, are not contaminated. They are 
made from pure forest fibre, such as logging residual s (small diameter stems and branches) and 
residues (sawdust) from logs being converted into lumber in sawmills. Wood pellets are beneficial 
for the environment and can contribute to China's goal of enhancing environmental protections. 
Wood pellets are a re newable, low -carbon resource and switching from coal to wood pellets reduces 
GHG emissions significantly. We urge China to consider other mechanisms to address the very 
specific problem of contaminated materials, while ensuring that mutually beneficial tra de can 
continue in a predictable manner and fulfilling environmental protection goals. We would be pleased 
to provide additional information on the nature of wood pellet production in Canada.  
2.310.   In response, the representative of China  provided the following statement. China has been 
pushing for ecological progress, pro -actively practicing 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 the purpose of safeguarding the 
ecological safety and population health  to the maximum extent possible.  
2.311.   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 and issued the relevant national standards as recycling materials for copper, 
recycling materials for brass, recycling materials for cast aluminium alloys, recycling iron -steel 
materials and etc. It has been noticed internationally that  cross-border transfers of wastes to 
developing Members brings serious environmental pollution problems, and international society  is 
actively taking measures against it. In May of 2019, the 14th session of the Conference of the Parties 
to the Basel Conven tion, 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. A t present, not 
only China, but also every Member should follow the fundamental principle of disposal and absorbing 
the wastes it has generated on its own. Only on the basis of this principle can we reach a better 
consensus on managing solid waste pollution  and search for a solution to this problem. At the same 
time, abiding by this principle will also contribute to the promotion of the global green low -carbon 
circular development, and the creation of a clean and beautiful world.  G/TBT/M/83  
 
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  2.1.3.35   Viet Nam - Cybersecurity Mea sures (ID 54467) 
2.312.   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 Vietnam have 
any updates to share on the  status of the draft decree?  
2.313.   The representative of Australia  provided the following statement. We share other Members' 
concerns with a number of concepts in Viet Nam's Cybersecurity Law. Australia and other Members 
have provided feedback on Viet Nam's draf t 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 -commerce; 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 objective 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 objectives. This may affect 
Viet Nam's reputation as an o pen 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.  
2.314.   The representative of the European Union  provided the following statement. The European 
Union shares the Member's concerns on the Vietnamese Cybersecurity law as regards its potential 
economic impact and its compatibility with Viet Nam's commitments under the WTO. The European 
Union would like to have information on whether Viet Nam has adopted the Implementing Decree 
on Cybersecurity and invites Viet Nam to seriously consider EU concerns and continue the dialogue 
to ensure alignment to international best p ractices. We would also appreciate information on any 
other draft implementing measures and on whether comments from interested parties, including 
industry and stakeholders, are considered. The European Union kindly requests that Viet Nam 
notifies the Cybersecurity 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 develop and implement Cybersecurity measures in fu ll respect of 
WTO principles, such as non -discrimination and proportionality and to take into consideration 
available international standards and practices.  
2.315.   The representative of Canada  provided the following statement. Canada recognizes the 
importance of cybersecurity and appropriate measures to preserve it, and appreciates the efforts 
Viet Nam is undertaking to develop measures implementing its Cybersecurity Law. Nonetheless, 
Canada shares other WTO Members' concerns and continues to have issues with the compatibility 
of Viet Nam's measures with its WTO commitments. In line with our previous statements, Canada 
continues to seek: Viet Nam's recognition that, as currently drafted, the law and implementing 
decree could have very extensive product coverage; no tification by Viet Nam of the law and 
implementing decree to the TBT Committee; and the use of international standards and conformity 
assessment frameworks including the CCRA certification process; Could Viet Nam please update the 
Committee on the status o f the implementing decree and what steps it plans to take next?  
2.316.   In response, the representative of Viet Nam  provided the following statement. The 
Vietnamese Law on Cybersecurity and the draft Decree for implementing certain articles of this 
Cybersecurity L aw have not regulated technical requirements with regard to information technology 
products or equipment. Viet Nam would like to reiterate that our process has been transparent with 
an open mind. All stakeholders' comments have been reviewed for internal c onsideration. The draft 
Decree for implementing certain articles of Viet Nam's Cyber Security Law has been developed in a 
manner of being suitable to reality and creating the most auspicious conditions for foreign 
enterprises operating in Viet Nam, without  any obstacle to the development of the Digital Economy. 
The draft Decree for implementing certain articles of this Cybersecurity Law was submitted to the 
Prime Minister of Viet Nam in November 2020 and will be issued soon.  
 
67 For previous statements follow the thread under ID 544. G/TBT/M/83  
 
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  2.1.3.36   Russian Federation - Federal law  No 487 -FZ, providing a framework for 
comprehensive use of special labelling and traceability of goods and Decision No. 792 -r 
specifying the goods to which labelling will apply and the dates of introduction of the 
mandatory labelling (ID 56768) 
2.317.   The represe ntative of the European Union  provided the following statement. On 28 April 
2018 the Russian Government adopted decision № 792 -R, listing goods which will be subject to 
mandatory marking. The EU has very serious concerns on the proportionality of the measu re: 
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 produc ts 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 avoidance. Though we commend 
the Russia n 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, "Membe rs 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 und er the TBT Agreement before its adoption. The Russian 
Government adopted Resolution No 515 on 26 April 2019 on the "marking of goods subject to 
mandatory labelling by means of identification ". This measure also falls within the scope of the TBT 
Agreement a nd 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. Som e 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 Russ ian 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 exac t 
requirements is still lacking. Moreover, the manufacturers have been considerably affected by the 
outbreak of the COVID -19 and all corresponding consequences, such as lockdowns, availability of 
employees, transport disruptions, etc. Disruptions in the su pplies of medicines to the Russian market 
that occurred in autumn 2020, as a direct consequence of shortcomings on both sides, the 
businesses and the operator of the system, fully demonstrated the need for sufficient transition 
periods. Therefore, an exten sion 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 20 20 and those planned 
for 2021.  
2.318.   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; tyres - 1 November 2020; textiles - 1 January 2021; dairy - 20 January 
2021 and 1 October 2021; bottled water - pilot project until the end of February 2021; beer - pilot 
planned to start as of 1 April 2021. We ask the Russian Federation to take into consideration t he 
European Union's comments, to ensure that the implementation of this measure is not unnecessarily 
trade -restrictive, in accordance with the WTO TBT Agreement.  
2.319.   In response, the representative of the Russian Federation  provided the following statement. 
The Russian Federation reiterates its statements made during the previous meetings of the 
Committee on Technical Barriers to Trade and sticks to the position that this measure cannot be 
considered as the technical regulation due to the fact that the system d oes not meet the 
requirements for technical regulations set out in Annex 1 of the Agreement on TBT. We do not 
consider the system as disproportionate. The concept of the system in respect of each product 
category is elaborated in collaboration with compani es involved in manufacturing, import and 
distribution of the respective product. The business community is extensively consulted before the 
approval of the system for each product. Mandatory implementation of the system for each product 
category is precede d by voluntary experiment with importers, manufacturers and representatives of 
foreign stakeholders in order to ensure system performance and adjust it to specificities of 
production and distribution process of each product. Also, transition periods for st ocks are provided. 
All described steps allow interested companies to shape new requirements as well to prepare to 
 
68 For previous statements follow the thread under ID 567. G/TBT/M/83  
 
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  them beforehand. To address the EU's claim that the system is not operational, we would provide 
the following data. According to the statistic s of the Operator of the System, to date approximately 
19 billion codes have been issued for tobacco products, 2 billion codes for shoes, 6.7 billion for 
pharmaceuticals, about 1.4 billion codes for textiles, 86 million for perfumes, 66.3 million for tyres . 
Figures show that the system is up and running with no major problems unsolved . Temporary 
difficulties in pharmaceutical market right after the system became operational for medical products, 
as mentioned by the EU, were promptly addressed by the Governm ent of the Russian Federation 
through the Resolution № 1779 on the 2 November 2020. Faithful manufacturers and importers 
should benefit from the system as illicit products are removed from the market.  
2.1.3.37   Republic of Korea - Package Recycle Classification Regu lation,  
G/TBT/N/ KOR/843 ,  G/TBT/ N/KOR/844 , G/TBT/N/KOR/857 , G/TBT/N/KOR/918 , 
G/TBT/N/KOR/919 , G/TBT/N/KOR/937  (ID 58869) 
2.320.   The representative of the European Union  provided the following statement. The EU strongly 
supports actions taken to protect the environment and acknowledges the efforts made by the 
Republic of Korea to facilitate the recycling procedure by encouraging prod ucers to place recycle -
friendly products on the market. However, the EU remains concerned about the negative impact that 
the notified measure would have on trade. The EU welcomes the exemption from the labelling 
requirement given to producers of wine and w hisky. However, the EU continues to be concerned 
about the requirements for olive oil bottles. These too can require opaque packaging in order to 
avoid sunlight deterioration and preserve the product integrity. Justification documents for the 
exemption wer e provided to the Korean Ministry of the Environment in June 2020, and EU producers 
and importers of olive oil are currently making individual exemption requests as well. The EU would 
appreciate a positive review of these exemption requests without further  delay for olive oil bottles, 
and for other producers that have made an exemption request. The EU would also like to know when 
the next meeting will take place of the Packing Materials Review Committee, who process these 
exemption requests.  
2.321.   The representat ive of Australia  provided the following 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 provi ding an exclusion 
from displaying recyclability evaluation results on wine bottles ("labelling exemption"). Australia 
seeks clarification that the labelling exemption provided to wine bottles is provided on the basis that 
the wine bottles, being made of gl ass, are not "difficult to recycle". Australia seeks clarification that 
in the case that a labelling exemption is provided on the basis that the bottles are not "difficult to 
recycle", that this exemption would also be applied consistently to the environme ntal fee.  
2.322.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the amendments to the implementing regulations of the Act on the Promotion of Saving 
and Recycling of Resources, notified by the Republic of Korea o n 9 September 2019 to the Members 
of this Committee in notification G/TBT/N/KOR/857 . Regarding recycling criteria, this measure 
requires materials and packaging structures to be classified and evaluated in accordance with a 
criterion of recyclability, and that once the degree of re cyclability of a packing material has been 
determined, it must be displayed on the labelling of the products, except for a specific group of 
products that have been exempted from this requirement. This measure is in the interest of the 
Mexican industry exp orting alcoholic beverages to the Republic of Korea, due to the financial impact 
that it represents for its production, and the Government of Mexico is therefore interested in knowing 
whether tequila will be exempt from this requirement.  
2.323.   In light of the ab ove, the Government of Mexico requests the delegation of the Republic of 
Korea to:  Share the list of products exempt from the requirement for the degree of recyclability to 
be included on labelling, as well as clarify whether there are any procedures to be  followed to request 
the exemption of certain products from this requirement, which in this particular case, would be an 
exemption for tequila.  Share the status of the measure. The latest update was notified in November 
2019. We would therefore like to hav e information on the expected date of entry into force, as well 
as the latest version of the measure, preferably in English.  The delegation of Mexico thanks the 
delegation of the Republic of Korea for giving its consideration to this statement and the requ ests 
made therein.  
 
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  2.324.   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 reduci ng waste. New Zealand would like to thank the 
Republic of Korea for providing a response to our written comments and providing a copy of the 
standard for the quality structure and recyclability of packing materials. New Zealand would 
appreciate clarificati on as to whether further specificity will be added to the guidelines contained 
within the standard. We would also appreciate confirmation of the length of time that will be provided 
as a transition period before the measures come into force. It is importan t that traders have both 
sufficient time and the necessary information to adapt their practices to comply with the regime and 
do not experience unnecessary barriers or costs to trade.  
2.325.   The representative of the United States  provided the following statement . The United States 
recognizes the importance for Korea to work towards reducing waste. We thank Korea for its 
response to U.S. industry comments on the recent notifications of the draft partial amendment of 
the Act on the Promotion of Saving and Recycling  of Resources, and for the recent notification of 
additional changes to this draft amendment in G/TBT/N/KOR/937 . In its response to industry 
comments, the Ministry of Environment (MOE) suggests that "simplified methods " such as QR codes 
may be allowed for more flexibility for small -capacity products. Does the MOE intend to release 
implementing guidance? We appreciate the opportunity to provide comments on any draft 
implementing guidance as soon as it becomes available. We understand that the implementation 
date in G/TBT/N/KOR/918  was six months after the dat e of adoption and in G/TBT /N/KOR/919  was 
one year from the date of adoption, but the recent G/TBT/N/KOR/937  notification indicates both a 
date of adoption and implementation of 1 April 2021. Industry will need a minimum of one year from 
the date of adoption of implementing regulations to incorporate additio nal labelling, and we urge a 
reasonable timeline to allow producers to adapt. MOE states in its 29 December response to US 
industry comments, "Newly released products will be given a one -year grace period … and existing 
products will be flexibly applied wi th a three -year grace period after the revision. " Will that three -
year grace period begin on the proposed date of entry into force of 1 April 2021? How does MOE 
define "newly " in "newly released products "? What does "flexibly applied " mean? Will all existi ng 
products be afforded the three -year grace period? How will the grace periods be reconciled with 
inspection requirements in Article 9 -(4)? The requirements to include all relevant testing information 
on a mandatory label increases production timelines and complexities. A company will need to 
complete all testing before finalizing the labels, extending the timeline and adding additional 
admin istrative costs. MOE's response to US industry comments states that "Mandatory labelling is 
intended to encourage product manufacturers to reduce packaging waste by checking compliance 
with criteria for packaging materials and methods of packaging in advan ce." We understand that the 
Recycling Act currently requires a check of compliance and has a mechanism to have a product 
inspected if it is believed that a company is not following the requirements of the Recycling Act. How 
does the proposed amendment for additional labelling help further the stated objective?  
2.326.   The representative of Chile provided the following statement. Chile thanks the Republic of 
Korea for its notifications submitted to the Committee on this matter. Chile shares the concerns 
expressed by  other delegations that have already taken the floor. Chile recognizes the right of the 
Republic of Korea to implement regulations that promote waste reduction and the production of 
easily recyclable packaging materials. It should be noted that the Ministr y of the Environment in 
Chile has a particular interest in the development of public policies that encourage the circular 
economy; however, this type of regulation should not be an unnecessary obstacle to trade, which, 
as indicated by the Chilean wine and drinks industry, this measure will create.  
2.327.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to thank member States for their interest to this regulation, and would like to 
deliver official announce ment from the competent authority. A glass bottle containing tequila is not 
exempt from displaying the "Difficult for Recycling" grade based on the Ministry of Environment 
Notice, Packaging Materials/Structure Grade Display Standards, because tequila is no t classified as 
fruit wine or whiskey. In accordance with the Notice, however, if the Minister of Environment 
acknowledges that the grade may not be marked after review by the Packaging Materials and 
Structure Review Committee composed of qualified experts , the duty to label the grade may be 
waived. The Notice enumerates the examples of packaging materials that are exempt from the 
labelling duty such as the paper packs with aluminium foil along with the wine bottles, and whiskey 
bottles. In order to be reco gnized as a packaging material subject to exemption, the packaging 
material manufacturer or importer needs to submit the document needed to the Korean Ministry of 
Environment to prove that the material is difficult to be changed due to concerns over potent ial G/TBT/M/83  
 
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  functional failure of the product. Afterwards, the Packaging Materials and Structure Review 
Committee operated by the Ministry of Environment will review the matters and decide whether or 
not to waive the duty of labelling.  
2.328.   Wine bottles are the packagi ng materials that are recognized as the items to be exempt from 
labelling duty due to concerns about product malfunctions when the packaging material or structure 
is changed. Please note that this labelling duty exemption does not correspond to the exempti on of 
their "Difficult for Recycling " grade itself. We could find that the quality of olive oil can be affected 
when the bottle is colourless according to the documents EU sent. However, clear evidence or 
relevant data could not be identified as to whether  the use of green and brown glass bottles specified 
in the above notification can affect the quality of olive oil. Some wine bottles with green or brown 
colour have been rated "Excellent for Recycling", so it is necessary to review whether olive oil bottle s 
can be packed in green or brown glass bottles. Therefore, if an olive oil manufacturer or importer 
requests an exemption from labelling of its products, the "Packaging Materials and Structure Review 
Committee" will decide whether to exempt them by review ing alternative materials and fairness 
among items. The regular meetings of the "Packaging Materials and Structure Review Committee" 
are held biannually, and occasional meetings are held under the convocation of the Minister of 
Environment, if necessary. T he most recent meeting was held in July of last year, and the schedule 
for the next meeting has not been set yet. Once the next meeting is scheduled, we will inform the 
EU delegation embassy with the timeline and required documents. Also, other requests th at give us 
today will be delivered to the relevant ministries.  
2.1.3.38   European Union - Concerns on regulations with regard to eco -design 
requirements for various products in EU , G/TBT/N/EU/615  (ID 59270) 
2.329.   The representative of China  provided the following statement. We suggest that: (i) the EU 
clarify whether washing machines without heating function are applicable to th is regulation. The 
draft regulation requires that the washing process of household washing machines should include 
an "ECO 40 -60" washing cycle, but washing machines without heating function are designed without 
the function of "ECO 40 -60", which means it cannot be tested according to the standard; and (ii) 
the EU cancel the requirement for spare parts delivery time. We believe that the delivery time for 
spare parts is a business practice and should not be stipulated and implemented as a regulation, 
and thi s measure is not feasible especially during the COVID -19 pandemic.  
2.330.   In response, the representative of the European Union  provided the following statement. 
The Ecodesign regulation on washing machines and washer dryers (2019/2023) also applies to 
machines w ithout a heating function (see articles 1 and 2). The definition of the "eco 40 -60" 
programme does not require the washing 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 
declared by the manufacturer, importer or authorised 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 ecodesign requirements on ene rgy 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 Ecodesign 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 for encouraging 
customers to have their appliances repaired. As indicated in An nex II to the Ecodesign 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 underlined in the Circular 
Economy Action Plan, a C ommunication 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.  
2.1.3.39   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (ID 
60271) 
2.331.   The representative of the European Union  provided the following statement. The European 
Union would like recall its concerns with regard to the Qatar Ministry of Public Health Circular of 
30 May 2019 establishing new import requirements for UHT milk and white cheese that entered into 
 
70 For previous statements follow the thread under ID 592. 
71 For previous statements follow the thread under ID 602. G/TBT/M/83  
 
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  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 th e SPS Agreement. The implementation of these rules 
continues to cause serious disruptions to EU exporters as compliance with these requirements is not 
feasible for certain cheeses and milk products. As a consequence, EU products covered by the 
measure cann ot be exported to Qatar anymore. The EU would like to recall that this measure is now 
in place for nearly two years without any clarity provided by Qatar on when this measure will be 
lifted. The EU is particularly concerned about the stringent restrictions  on the shelf -life that 
disadvantage imported products in comparison to local products, but also about certain product 
characteristics for UHT milk and white cheeses, in particular obligatory addition of vitamins to milk 
and low -fat-only requirement for ce rtain white cheeses. 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 
necessar y to fulfil the legitimate objective of public health protection. In this context, the EU would 
like to refer to Articles 2.1, 2.2 and 2.4 of the TBT Agreement. The EU would like to invite Qatar to 
suspend the application of the measure without further del ay, align it to the WTO rules and comply 
with its notification obligations. The EU would like to thank Qatar for bilateral exchanges during the 
past months, which unfortunately have not yet resulted in an effective solution. The EU is prepared 
to continue work constructively with Qatar to resolve this important issue.  
2.332.   The representative of the United States  provided the following statement. The United States 
remains concerned over disruptions to trade as a result of Qatar's Ministry of Public Health's (MPH)  
dairy products regulation, published in May 2019, which restricts the reconstitution of milk and shelf 
life of cheeses. Qatar adopted this measure without notifying it to the WTO, providing a comment 
period, or providing a reasonable implementation period . This measure appears to have been issued 
as a final measure. No comments were taken into account, and the measure has caused significant 
disruptions to trade since its implementation on 1 June 2019. Despite the United States participating 
in many bilater al discussions with Qatar, US exports continue to be blocked due to the enforcement 
of this measure, and businesses in Qatar have faced shortages of supplies needed for production. 
Therefore, we urge Qatar to suspend implementation of this measure until Qa tar fulfils its WTO TBT 
transparency obligations, including notification of the measure to the WTO TBT Committee so that 
Members may review and provide comments, and so Qatar can take comments into account.  
2.333.   The representative of Canada  provided the followi ng statement. Canada joins the United 
States and the European Union to reiterate its concerns with Qatar's new shelf -life requirements for 
identified milk and cheese products established by the Qatar Ministry of Public Health on 30 May 
2019. In its respons e at the last TBT Committee Meeting, Qatar stated that it has taken note of 
Member's concerns. However, despite efforts to obtain additional clarifications, both through several 
Meetings of this Committee and through Qatar's Enquiry Point, Canada's questio ns remain 
unanswered. Qatar has provided assurances that the relevant measures would apply equally to 
domestic and imported products. However, the overly restrictive shelf -life requirements and the 
lengthy ocean transit (50 -55 days) from Canada to Qatar ma ke it impossible for Canadian exporters 
of paneer cheese to fulfil contracts with Qatar importers and comply with the new 45 -day shelf -life 
requirements. As Canada has previously stated, these logistical limitations could effectively lead to 
favouring dome stic or close proximity sourcing of these products, which potentially leads to the 
discriminatory treatment of imported products. In light of Qatar's stated objective of ensuring the 
safety and quality of products sold in its market, Canada once again enco urages Qatar to notify this 
measure to the WTO, pursuant to the WTO's transparency obligations, and suspend its 
implementation to ensure that Member comments and concerns have been taken into account. 
Canada looks forward to receiving the requested clarifi cations and information from Qatar, which 
are detailed in Canada's intervention from the last TBT Committee Meeting, and we will continue to 
follow these discussions closely.  
2.334.   In response, the representative 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 s till 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 the relevan t measures apply equally to domestic and imported products 
and are therefore non -discriminatory in nature.  Furthermore, any impact that such regulations may G/TBT/M/83  
 
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  have on trade will not be more than necessary to contribute to the fulfilment of the legitimate 
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 signific ant 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 int erested Members to provide additional explanation where necessary.  
2.1.3.40   Republic of Korea - Ballast Water Management Act (ID 60672) 
2.335.   The representative of the European Union  provided the following statement. The EU would 
like to recall its concerns raised in pr evious 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 tes ts that were already performed. Despite numerous reports and clarifications being 
submitted to the Korea Institute of Ocean Science and Technology (KIOST) in order to obtain the 
certification, KIOST continues to request even more additional information. Th is is despite the fact 
that the tests that have already been submitted are issued by a globally -recognized classification 
society (DNV GL) and certification body (DHI Group), which are sufficient for certification by many 
flag states. For example, in Denma rk, there is an automatic certification when the testing is carried 
out by an approved Recognised Organisation (RO), such as DNV GL; other member States require 
three weeks to three months approximately; and third countries take up to eight months. The 
certification process has taken more than two years in South Korea and the certificate has still not 
been issued. This does not appear consistent with Article 5.2.3 of the TBT Agreement. The EU would 
like to thank the Republic of Korea for facilitating a redu ction in the fee request but would also like 
to underline the importance of a prompt issuance of the certificates for European companies, which 
remain under review.  
2.336.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to thank EU for its interest to this regulation, and would like to deliver official 
announcement from the competent authority. As explained at various meetings such as the WTO 
and FTA meetings, this delegation would like to say that Korea' s Ballast Water Management Act has 
already stipulated that foreign and Korean products shall be treated equally in terms of the conditions 
for type approval. So, we would like to reiterate that Korea has no technical or institutional barriers 
to foreign pr oducts in the type approval procedure of the Ballast Water Management System. In the 
case of a European company that is undergoing the type approval process in Korea, the deliberation 
process was completed on 4 January 2021, and the Ministry of Oceans and Fisheries notified the 
company of the deliberation results. The company was exempted from the readiness evaluation and 
environmental test, meaning that it is required to conduct only two seawater tests for the land -
based test, and validity verification for  the shipboard test. It can obtain a type approval certificate 
if it passes these tests, but it has not yet conducted them. On the other hand, in the case of a Korean 
company that applied for a foreign type approval at around the same time, the company imm ediately 
carried out the tests it was notified to conduct even though the deliberation results called for more 
demanding requirements compared to the case of the European company, such as the requirement 
to conduct four times seawater tests for the land -based test, and validity verification for the 
shipboard test. So, Korea would like to inform you once again that Korea is affording equal treatment 
to domestic and foreign companies without imposing any technical or institutional barriers in terms 
of the typ e approval of the Ballast Water Management System. In addition, this delegation would 
like to inform you that any comments or enquiries will be received by the Ministry of Oceans and 
Fisheries, which is the competent authority of Korea.  
2.1.3.41   India - Air Conditi oner and its related Parts (Quality Control) Order, 2019 , 
G/TBT/N/IND/131 , G/TBT/N/IND/143  (ID 59873) 
2.337.   The representative of China  provided the following statement. Firstly, China would like to 
suggest India change the testing and factory audit method. At present, the factory audit or inspection 
to be conducted by the Bureau of Indian Standards (BIS) cannot be carried out in other Members 
due to the COVID -19 pandemic. In this regard, Chin a would like to suggest India conduct remote 
factory inspection or audit to maintain robust accredited certification. To respond to extraordinary 
 
72 For previous statements follow the thread under ID 606. 
73 For previous statements follow the thread under ID 598. G/TBT/M/83  
 
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  circumstances , the general mechanism established by IAF ID3 Informative Document for 
Management of Extraordina ry Events or Circumstances Affecting ABs, CABs, and Certified 
Organizations, and IAF ID4 Mandatory Document for the Use of Information and Communication 
Technology (ICT) for Auditing/Assessment Purposes , instructs the IAF Member ABs and accredited 
Conformi ty Assessment Bodies on how to use information and communication technologies to 
support and maintain the integrity of the audit or assessment process. In addition, many Members' 
experience has shown that remote auditing with ICT can achieve the audit obje ctives. We also 
welcome India to accept the third -party laboratory test or the third -party certification body of other 
Members.  
2.338.   Secondly, we suggest India to further extend the transitional period of the implementation 
of the regulation. Taking into accoun t the current progress of testing and certification and the 
difference between the parts and the whole machine certification, we suggest that India postpone 
the certification of air conditioning parts (two devices, electronic control) to 1 January 2022, an d 
postpone the certification of the whole machine to 1 July 2022. Thirdly, we suggest India use 
ISO9001 quality management system instead. According to our understanding, the BIS certification 
of India includes factory system approval and product (parts) a pproval. For factory system approval: 
at present, it can only be carried out after the on -site factory audit and it can only be arranged 
according to the schedule of BIS officials. We hope factory audit can accept the equivalent effect of 
the international  general management system, such as the ISO9001 quality management system, 
which is also the recognition certificate for the production capacity of the factory. For product 
(component) approval: at present, samples must be sent to India for testing. From t he perspective 
of standard differences , it is suggested that India can accept, for example, European  Union product 
certification (CE) or International Electrical Commission product certification.  
2.339.   In response, the representative of India provided the follow ing statement. The QCO on AC 
was notified in December 2019 with implementation date 1 June 2020 and this was extended and 
the new date of implementation is 1 January 2021.  
2.1.3.42   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Produ ct Safety Program (ID 61574) 
2.340.   The representative of the European Union  provided the following statement. The European 
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. The sector of 
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 asses sment 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 notified bodies authorized by 
Saudi Standards, Metrology and Quality Organisation (SASO). In particular, EU exporters report that 
such notified bodies continue to find new ways to increase costs when carrying out conformity 
assessment procedures. The European Union would like to raise the following points. Manufacturers 
report that despite the latest GSO Guidance specifying test reports are only required for one 
representative item from a product group, Notified Bodies (NBs) frequently request physical samples 
of all products in a group, and not only of the representative items. This neutralises the benefit of 
only having an additional as sessment for GCTS, based on a representative item. A physical 
inspection of all items in a product group is still very burdensome and costly.  
2.341.   There is misunderstanding related to which test reports are required. GSO has created a 
"toy categorization docume nt" published in June 2020, which includes EN 71 -9. This testing is not a 
useful method when companies have full control of the substances used in toys. This is exactly the 
objective of chemical control processes and the chemical safety assessment that is a requirement 
for both the European Union Toy Safety Directive and the GCTS documentation review. Misalignment 
between scope of Technical regulation for toys (products that require the GCTS), HTS codes and 
SABER. The latter requires GCTS for all imports un der the toy and games HTS codes (9503 and 
 
74 For previous statements follow the thread under ID 615. G/TBT/M/83  
 
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  9504). Some toy and game products are age graded 14+ and therefore officially do not fall under 
the Toys Technical Regulation, but are still tested against these requirements. However, Notified 
Bodies do not accept  these products for GCTS registration, based on the older age grade of 14+ and 
therefore not falling under the Toy Technical Regulation. In these cases, SABER cannot process the 
item because of not having a GCTS code. Changing HTS codes for import is not a llowed for the Gulf 
region – so companies cannot receive GCTS and cannot change the HTS code neither. Therefore, 
these products currently cannot be imported into Saudi Arabia. The ceramic sector is also very 
affected. Ever since its establishment, the Saud i Quality Mark procedure has been non -transparent 
to applicants and still today, after 1.5 years since its entry into force, there are no official guidelines 
issued by SASO for the audit process, leaving the interpretation of the Technical Regulation to th e 
discretion of the Accredited Certification Bodies (CBs). Obtaining the Saudi Quality Mark for EU 
producers of ceramic tiles is expensive, burdensome, time -consuming and unpredictable sometimes.  
2.342.   The European Union would like to raise the following points,  which represent a major 
concern. Audits are disproportionate and exceed the requirements set out in ISO standards.  To 
obtain the SQM, applicants are requested to prove compliance with SASO ISO 13006, which is 
supposedly based on the International Standard  ISO 13006 (for specific characteristics of ceramic 
tiles). However, the SQM audits requires to conduct all the tests for rectified and non -rectified tiles, 
which seems to be unnecessary and arbitrarily requested by SASO in addition to the official ISO 
parameters. High Costs.  According to the data available, this certification is not only one of the most 
expensive certifications in the world but it is also discriminatory towards SMEs. While the previous 
system applied in Saudi Arabia was based on different fees commensurate with the shipment value, 
the current SQM has a (very high) fixed price that is prohibitive for SMEs, which are simply not able 
to invest this amount of money for limited volumes exported each year. This has de facto  excluded 
many EU produ cers from the market, as most of them are SMEs. Limited number of Certification 
Bodies.  The limited number of Certification Bodies accredited by SASO in Europe creates bottlenecks 
as applicants are faced with long waiting times before being assigned a date  for the audit. This delay 
results in foregone business for EU companies. Unclear audit procedures . SASO has never published 
a list of documentation required for the audit; hence, there is no standardized procedure and there 
can be discrepancies in the aud it requirements set out by different Certification Bodies. As a result, 
the SQM procedures are unpredictable and applicants are subject to different conditions based on 
the Certification Body they utilize. Yearly Surveillance Audits . The yearly renewal of the SQM should 
entail less requirements due to its surveillance nature. However, companies have reported that the 
yearly surveillance includes the same level of detail as the first SQM audit – which is completely 
disproportionate to its purpose. In conclus ion, the European Union would like to kindly invite the 
Kingdom of Saudi Arabia to ensure efficient and less costly procedures for all products included in 
the new conformity assessment system. The European Union is available to discuss this issue with 
the Saudi authorities bilaterally.  
2.343.   The representative of the United States  provided the following statement. The United States 
reiterates its concerns regarding the conformity assessment procedures required under the Saleem 
Saudi Product Safety program using the Saber  system. Stakeholders continue to have a number of 
questions and concerns regarding this programme, most significantly the lack of documentation. 
Can you provide copies of all relevant regulations instituting the program and the outlining the scop e 
of product coverage? To address at least some of the concerns from stakeholders, the United States 
requests that the Kingdom of Saudi Arabia simplify the registration and certification process and 
implement clear and transparent guidelines.  
2.344.   The represent ative of Switzerland  provided the following statement. Switzerland maintains 
its concerns over the potential impact of the Saber Conformity Assessment Online Platform on 
bilateral trade with the Kingdom of Saudi Arabia in a range of products, including tex tiles and 
machineries. The registration and certification process remains costly, complex and time -consuming 
for our exporters. Manufacturers continue to report that recognized bodies require disproportionate 
fees when carrying out conformity assessment pr ocedures. Depending on the sector, strict 
conformity assessment procedures apply for products considered in their majority to be low -risk 
products. Furthermore, additional third party certification is required for low -risk products that 
already have been c ertified and registered in the system. In particular for companies exporting 
quality products in small quantities, the registration and certification process leads to 
disproportionate costs and documentation requirements which is prohibitive to enter the m arket. 
Switzerland reiterates its call 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. Swit zerland would further appreciate the G/TBT/M/83  
 
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  publishing of all relevant regulations instituting the programme and outlining the scope of products 
coverage. The documentation and certification requirements, as well as registration and certification 
fees, should be kept to what is necessary to assure an effective implementation of the applicable 
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.  
2.345.   In re sponse, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia thanks the European Union, United States and Switzerland for their interest 
in this matter. We want to clarify that SALEEM program works through the de velopment of an 
integrated systems of regulations and standards that conform to internationally recognized 
professional practices by developing a highly efficient system for measuring product safety indicator 
in the market through mechanisms and procedures  that comply with the technical regulations of 
each product, especially essential requirements for health of human and animals, environment 
protection, and ensure the effectiveness of the services provided by legislative and regulatory bodies 
to achieve sa fety by conformity of those products to SASO Standards. The main purpose of Saber is 
to improve the import experience and obtain the certificates of conformity and shipment by using 
one platform integrated with other entities. Saber has reduced the time to  one to seven working 
days compared to 7 -15 working days previously. In addition, Saber is linked directly to Saudi 
customs, which allows products clearance within 24 hours. Moreover, Saber is implementing UX 
design project to improve the experience for th e importer in registering their product and applying 
for their required certifications. Please note that registration and applying for certification is done by 
the importer in Saudi and the local manufactories. We advise visiting the website below to find the 
requirement for each HS -code and note that you can search by using the first six digits since it is 
matching the international HS -code.75 
2.346.   The validity of the certificate is one year for the certificate of conformity and three years for 
the Saudi qualit y mark as well as the G -Mark. However, the test report can be valid for three to five 
years if nothing has been changed in the production line or the composite of the product. In Saber 
platform, clients can search by six digits select from the results for the nearest description of their 
product. In terms of GSO toy regulation, GCTS tracking symbol must be issued through GSO 
platform. Once the GCTS is obtained, the shipment certificates can be easily issued through Saber 
platform. We strongly advise all toy s industries to contact the notified bodies according to the GSO 
Technical Regulation for Toys scheme (listed in Saber platform) for detailed explanations regarding 
the test report and GCTS requirements. The conformity assessment procedure is based on the 
technical regulations published by SASO. These technical regulations were developed to protect 
consumer from high/medium risk products based on international best practices. The technical 
regulations can be found in the official website of SASO via the lin k below.76 Please note that the 
Saudi Customs is the authority responsible for the HS -code, and all HS -codes can be found on their 
website. Therefore, we recommend viewing their website to find the right HS -code that matches the 
product description.  
2.347.   SASO i s committed to reviewing some details of these procedures of conformity assessment 
to extend the validity of test reports used in issuing the product conformity certificate. The technical 
regulations for the acceptance of conformity assessment bodies in ac cordance with the international 
standard ISO/IEC 17065 set this requirement to ensure the efficiency of test reports issued by 
laboratories and that they are issued by a laboratory accredited by a full member accreditation 
centre in ILAC. The laboratory (i n addition to being an accredited entity) must be registered by SASO 
in order to be able to issue test reports for energy efficiency products. The conformity assessment 
procedures done by the manufacture differ from those done by an importer. This is expla ined in 
Article 18 of the GSO Toys regulation and detailed in appendix 4 and 5 of the regulation. Therefore, 
the certificate and GCTS (GSO Conformity Tracking Symbol) must be issued through GSO. Once the 
GCTS has been obtained from GSO, it can easily issue  the shipment certificates through the Saber 
platform. We advise the US toys industry stakeholders to contact the notified bodies in GSO Technical 
Regulation for Toys in Saber platform for detailed explanations regarding the test report  and GCTS. 
SASO audi ts the conformity assessment procedures and requirement to ensure fair trade. Therefore, 
we encourage all interested parties that if they have any concerns regarding notified bodies, they 
contact SASO immediately via email.77 
 
75 https://saber.sa/home/hscodes   
76 http://www.saso.gov.sa/en/laws -and-regulations/technical_regulations/pages/default.aspx   
77 info@saso.gov.sa   G/TBT/M/83  
 
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  2.1.3.43   Mongolia - Mandatory Requireme nt for Enrichment of Agricultural Products with 
Vitamins (ID 61678) 
2.348.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation would like to reiterate its statements made during the previous meetings of the 
Committee on TBT and the Council for Trade in Goods with respect to the requirements on the 
mandatory fortification of  wheat flour applied in Mongolia. Although Russia raised this issue multiple 
times, Mongolia has not provided clarification with regard to the international standard that was 
used for the development of Mongolian standard on wheat flour fortification MNS 6 812:2019 of 
30 December 2019. In particular, it remains unclear to Russia the reasons of deviation from the 
WHO recommendation as well as the scientific basis for establishing the dosage of vitamins. Other 
areas of concern are implementation and enforcemen t of these mandatory requirements in Mongolia. 
The fact that domestic non -enriched wheat flour is present on retail shelves in Mongolia while foreign 
producers have to comply with fortification requirements accords less favourable treatment to 
imported flo ur. Also, Russia requests Mongolia to provide the information on accredited laboratories, 
which examine wheat flour on compliance with the fortification requirements. Taking into account 
all the above, the Russian Federation is looking forward to getting f urther clarifications regarding 
the issues reiterated in our statement today. We will continue to monitor the implementation of this 
measure. We again urge Mongolia to intensify bilateral dialogue on these issues.  
2.349.   In response, the representative of Mongoli a provided the following statement. We thank 
again the Russian Federation for the statement. We also thank Russia for the bilateral meeting that 
was held in Moscow on the matter on 11 February 2021. The Mongolian Government Resolution 
No.336 of 2018 approv ed the list of products necessary for enrichment and the volume of enriching 
ingredient. The Mongolian Agency of Standardization and Measurement has approved the technical 
requirements for enriched wheat flour MNS 6812:2019 and the technical requirements f or enriching 
ingredient for wheat flour MNS 6811:2019. These requirements were adopted based on international 
standards CAC152:1995; CAC/GL09 -1987, CACRCP1:2003 as well as the recommendations of the 
World Health Organization. They are available online. Tec hnical requirements for enriched wheat 
flour MNS 6812:2019 apply to both domestically produced and imported wheat flour.  The National 
Laboratory for Food Safety (NLFS) is working to be accredited to certify enriched food and enriching 
ingredients. We would  like to inform that our statistics show imports of wheat flour from Russia both 
in 2019 and 2020. Mongolia will continue working with the Russian Federation on this matter.  
2.1.3.44   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: Gene ral specifications for the labelling of pre -packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9 , G/TBT/N/MEX/178/Add.10 , 
G/TBT/N/MEX/178/Add.11 , G/TBT/N/MEX/178/Add.13 , G/TBT/N/MEX/468  y 
G/TBT/GEN/302  (ID 60879) 
2.350.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
support the trade concern raised by Chile, 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, t he 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 scientifi c 
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 that the Mexican delegation c larify its position regarding the work 
carried out in the Codex in this area.  Costa Rica would like to reiterate the request made to the 
Mexican delegation at this Committee's previous meeting, to indicate the scientific basis or 
international reference st andard used to define the key parameters of the standard in question, and 
to provide relevant justification for the use of the front -of-pack warning sign as supplementary 
nutrition information, the scientific basis for setting classification parameters, ac cording to which a 
product is considered to contain excessive calories, sugar, saturated fats, trans fats or sodium, given 
that they are not Codex -based.  
2.351.   Turning to the consumption by children of products containing added caffeine or sugar 
substitutes, Cos ta Rica requests the delegation of Mexico to refer to either the international reference 
 
78 For previous statements follow the thread under ID 616. 
79 For previous statements follow the thread under ID 608. G/TBT/M/83  
 
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  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 me asure adopted by Mexico could 
generate inconsistencies with TBT Agreement obligations, in particular those established in Articles 
2.2 and 2.4.  Costa Rica maintains its view in this Committee 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, constitutes a challenge that hampers global 
economic recovery efforts, especially in developing countries that are reliant on int ernational trade, 
such as Costa Rica. This is without prejudice to the power that Members have to adopt them if 
considered necessary.  Costa Rica would be grateful if the Mexican delegation could inform it about 
the progress of this draft amendment.  
2.352.   The rep resentative of the United States  provided the following statement. We refer to 
previous interventions, and support extending the use of stickering in order to meet the 
requirements of the Mexican regulation.  
2.353.   The representative of Chile provided the followi ng statement. Chile wishes to highlight, and 
express its appreciation to Mexico for, the outcome of a bilateral meeting, according to which, as we 
understand it, the permanent use of stickers to incorporate warnings on front -of-pack labels would 
provide a solution.  
2.354.   The representative of Guatemala  provided the following statement. The new Mexican Official 
Standard (NOM) for the labelling of pre -packaged food and non -alcoholic beverages (NOM -051-
SCFI/SSA1 -2010), in force since 1 October 2020, aims to establish the commercial and health 
information that must be contained on the labell ing of the pre -packaged domestic or foreign products 
marketed in the national territory, as well as to determine the characteristics of such information 
and to establish a system of front -of-pack labelling for the general population, in order to inform the  
consumers clearly and truthfully of the content of critical nutrients presenting health risks in 
excessive consumption.  As has been stated at previous meetings, we appreciate  Mexico's efforts to 
protect human  health and provide consumer information. Never theless, we reiterate that, pursuant 
to Article  2.2 of the TBT  Agreement, measures must not be more trade -restrictive than necessary 
to fulfil that objective. We have raised this matter during discussions at previous meetings, and our 
position remains unch anged.  
2.355.   With regard to the use of adhesive labels and stickers, the following reference is made to 
Mexico's publications and notifications:  The transitional articles of Mexican Official Standard NOM -
051-SCFI/SSA1 -2010, notified in document G/TBT/N/MEX/178/Add.9 , establi sh that the alternative 
provided for in one of transitional articles contained in the Standard can only be used until 31 March 
2021.  The transitional articles of the Amendment to the Agreement under which the Ministry of the 
Economy issues general rules an d criteria in respect of foreign trade , published on 1  October  2020 
and notified in document G/TBT/GEN/302 , also indicate that, until 31 March 2021, goods with 
adhesive transfers or stickers affixed to product labels may be presented for customs clearance.  We 
thank the Mexican Governme nt for the flexibility in the interpretation issued in the Criteria for the 
Application of Mexican Official Standards by the Under -Secretariat of Industry, Trade and 
Competitiveness, on the application of inputs not intended for the final consumer , bulk go ods, and 
raw materials, all of which are dated  26 October 2020. However, to date, there has been no provision 
in Mexico's legal framework which clarifies the possibility of using adhesive labels or stickers after 
1 April 2021 for imported products.  CODEX C XS 1-1985, General Standard for the Labelling of Pre -
packaged Foods , authorizes the use of a supplementary l abel which fully and accurately reflects the 
information contained on the original label. We therefore reiterate that the current standard deviates 
from the international reference standard, thus creating an unnecessary barrier to trade. Guatemala 
allows the use of supplementary labelling for Mexican products marketed in Guatemala and therefore 
requests reciprocity treatment in line with international  standards.  Guatemala reiterates its concern 
over the lack of harmonization of front -of-package labelling worldwide and of associated nutrient 
profiles.  For small and medium -sized enterprises trying to internationalize their operations, these 
are complex m easures that limit trade.   
2.356.   The representative of Paraguay  provided the following statement.  Paraguay refers to its  most 
recent statement and, given that its position remains unchanged, requests that its statement at the 
previous meeting of the Committee be reflected in the minutes of this current meeting . 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 the conce rn of other 
countries over the mandatory declaration of added sugar, which is not provided for under Codex G/TBT/M/83  
 
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  guidelines. Also, it concerns Paraguay that no analytical method can differentiate between total 
sugar and sugar added to a food, thus complicating t axation, 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.  
2.357.   The representative of Colombia  provided the following statement. Colo mbia supports 
Mexico's public health objective of reducing diet -related non -communicable diseases. However, our 
country wishes to support the trade concern 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 for pre -packaged food and non -alcoholic beverages containing sugars, fats or 
sodium.  In this regard, our in dustry has expressed concern about the implementation of the measure 
adopted by Mexico, not least given that this technical regulation may be more trade restrictive than 
necessary to fulfil public health objectives, as it does not appear to be based on rel evant international 
standards or sound scientific evidence, running contrary to Article 4 of the TBT/WTO Agreement on 
Technical Barriers to Trade. The standard may stigmatize certain foods based on non -technical 
classifications and criteria because they re fer to systems that are not clear or precise, causing 
confusion among consumers.  Regarding  the use of adhesive labels , we understand that the Mexican 
standard provides that this alterna tive may only be used until 31 M arch 2021. This situation will 
incur hi gh costs for enterprises, which will henceforth have to reflect the labelling requirements in 
printed form on packaging from the market of origin. This situation particularly affects small and 
medium -sized enterprises, which find it too costly to design an d use different packaging for each 
export market.  On this matter, we invite consideration of the Codex Standard CXS 1 -1985, which 
provides that a supplementary label should be allowed, fully and accurately reflecting the information 
appearing on the origin al label. We therefore respectfully request Mexico to extend the application 
of the rule allowing the indefinite use of adhesive labels or stickers with warning icons and messages 
on food packaging.  
2.358.   Colombia considers that the measure is more restrictive t han necessary and may become 
an unnecessary obstacle to trade, violating Article  2.2 of the T BT 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 c reating unnecessary obstacles to international trade. For this purpose, 
technical regulations shall not be more trade -restrictive than necessary to fulfil a legitimate 
objective ". Lastly , we consider that the measure could also have shortcomings from the p oint of 
view of competition, as it could limit the number of enterprises in the market, 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 an d 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 su bmitted by Colombia during 
the international public consultation phase. We 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 mini mum of two years.  
2.359.   The representative of El Salvador  provided the following statement. 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 Offici al 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 d ays until 10  December  2019. El 
Salvador submitted a number of comments on the amendment to the above -mentioned Standard, 
pointing out that while one of the aims of the amendment, according to Mexico, is to prevent and 
control obesity, there is, to date, an d in El Salvador's view, no technical and scientific proof of a 
direct link between the establishment of a warning label and a reduction in, or the control of, this 
disease; it is therefore questionable whether these measures would achieve any legitimate 
health-related objective. In addition to this, there are other factors, such as sedentariness, which 
play a more prominent role in obesity. The warning label is not a comprehensive solution to the 
problem and would have serious implications for trade.  G/TBT/M/83  
 
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  2.360.   El Sa lvador recognizes that another of Mexico's objectives is to provide consumers with 
accurate information so that they can make good nutritional decisions with a view to preventing 
non-communicable diseases such as obesity. Nevertheless, El Salvador consider s 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 theref ore 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 international standards and guidelines, thus not 
ensuring the promotion of more healthy diets. Furthermore, Mexico's proposed front -of-pack 
labelling system covers only processed products , and excludes non -processed products, which are 
produced domestically, thereby implying clear discrimination. El Salvador recognizes the efforts 
made by the Government of the Republic of Mexico to gather together all the comments on the 
above -mentioned St andard 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.  
2.361.   In response, the representative of Mexico provided the following statement. The delegation 
of Mexico welcomes the comments submitted by the delegations of Guatemala and Costa Rica via 
the eAgenda , as well as the comments submitted today by the United States of America and Chile.  
Regarding the questions on the proportionality of the measure, its purpose and conformity  with 
international standards, we invite those concerned to consult the information that was provided in 
previous Committee  discussions  and reflected in the minutes co ntained in documents G/TBT/M/80 , 
G/TBT/M/81  and G/TBT/M/82 . Regarding the use of stickers, it is important t o indicate the 
publication, on 10 July 2020,  of an Agreement allowing the use of adhesive materials on imported 
products in order to comply fully with the commercial and health information requirements 
established in the amendment to Mexican Official Stand ard NOM -051, which will enter  into force on 
1 April 2021 for the marketing of products to the final consumer. The necessary stickers should 
therefore be used before 1 April 2021 in order to comply with this technical regulation in time. There 
is no expiry date as this is a permanent mechanism.   
2.362.   Furthermore, the NOM Annex provides for four possibilities for importers to verify the 
compliance of their products with the Mexican Official Standards on commercial information, in short:  
Option 1 : It is not necessa ry to submit the inspection certificate issued by a third party (inspection 
unit). The label must be placed on the product in the country of origin and comply with the 
requirements of Mexican Official Standard NOM -051. Option 2 : It is necessary to submit t he 
inspection certificate issued together with the labelling of the goods to be imported. In this case, the 
products must be labelled in the country of origin.  Unlike option 1, in this case, the certificate  is 
prepared  prior to importation and is included at the time of importation.  Option 3 : If the product to 
be imported does not have a label, the labelling may be carried out in a general bonded warehouse 
in the national territ ory. Where the general bonded warehouse has been authorized as an inspection 
unit, it may carry out the inspection and thus  issue the certificate of compliance.  Option 4  (similar 
to option 3 ): If the product to be imported does not have a label, the labelling may be carried out 
at a private home in the national territory, where an ins pection unit may be employed to carry out 
the inspection and thus issue a certificate of compliance.  The delegation of Mexico reiterates its 
willingness to clarify any doubts that the Members of this Committee may have on the 
implementation of this measure . Such concerns may be sent in writing via the WTO contact point.  
2.1.3.45   India – Toys (Quality Control) Order, 2020 ( G/TBT/N/IND/131 ); Amendment in 
Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(G/TBT/N/IND/143 ) (ID 63280) 
2.363.   The representative  of the European Union  provided the following statement. The European 
Union is strongly concerned about India's Toys (Quality Control) Order, 20 20 (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 on multiple occasions during bilateral talks with India 
and at previous WTO TBT Committee meetings of February, May and October 2020. So far, the EU 
 
80 For previous statements follow the thread under ID 632. G/TBT/M/83  
 
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  is not aware of any response of India to our concerns. The EU would like to reiterate in particular 
the concerns related to the certification requirements recently introduced by the Bureau of Indian 
Standar ds (BIS). As of 1 January 2021, date when the regulatory order entered into force, all toy 
imports, including premium toys produced by European manufacturers which already comply with 
the highest standards of safety and quality, have come to standstill. Th e order mandates that only 
toys with BIS marking may enter the country as of 1 January 2021. Factory audits by BIS auditors 
are a precondition to obtain the necessary BIS marking. While domestic toy producers have had the 
opportunity to comply with regulat ory order and BIS auditors have audited domestic facilities. The 
same cannot be said for plants in third countries. EU companies already adhere to the strictest 
quality and safety standards, they have nonetheless committed to comply with Indian regulation.  
Consequently, EU companies have submitted the necessary applications well in time that furnish the 
Indian authorities with the necessary information to enable factory audits by BIS auditors.  
2.364.   However, as a result of the prevailing pandemic related travel r estrictions, BIS auditors have 
not responded to applications and requests from EU companies for in -person audits. EU companies 
therefore find themselves in a challenging situation. Firstly, despite fulfilling the highest international 
standards of quality and safety for toys their exports to India are at a standstill. Secondly, despite 
fulfilling the requirements laid out by the QCO (Quality Control Order) there is no way for them to 
comply, as exports to India require in -person audits by BIS, which are not  possible in current 
context. At this stage, there is no clarity as to when travel will return to normal in India and in third 
countries, as the pandemic continues to affect a large part of the world. It is difficult to envisage 
BIS auditors travelling to foreign plants in these conditions. The EU would therefore request India 
to allow third -party or virtual audits of third country factories (especially as such flexibility is allowed 
for domestic manufacturers) and in the meanwhile allow imports of toys, un der the continued 
enforcement of the DGFT system (in place until 31 December 2020) with Customs continuing testing 
imports for conformity with applicable Indian Standards by NABL accredited labs (as per DGFT 
Notification 33/2015 -20). Without these alternat ives, EU companies do not have a fair chance of 
being able to satisfy their existing consumer base in India, and their investments to date to grow 
the Indian market for premium quality toys are affected. The European Union would be grateful if 
India could respond directly to the concerns mentioned in the previous EU written comments, as 
well as to the concerns reiterated today.  
2.365.   The representative of the United States  provided the following statement. The United States 
has repeatedly raised concerns with Ind ia's treatment of imported toys since 2017. With each new 
requirement, India has made it more difficult for exporters to successfully bring safe toys to market. 
We support the Indian Government's objective to improve the quality of toys on the market. US t oy 
companies produce high -quality toys made to the highest international standards and the health and 
safety of children is a key priority for all of us. However, India's 1 January 2021 implementation of 
the Toys (Quality Control) Order, 2020 (QCO) has mad e it impossible for international toy companies 
to comply with the order given the apparent inability of the Bureau of Indian Standards (BIS) to 
conduct in -person audits of foreign manufacturing facilities during the COVID -19 pandemic. We 
understand that U S firms submitted applications for the required certification of their manufacturing 
plants, including overseas facilities, soon after the August 2020 BIS release of the QCO Product 
Manual. However, US industry reports that, although BIS authorities are cu rrently auditing domestic 
manufacturing facilities, they have yet to start audits of overseas manufacturing plants. To date, 
companies with manufacturing facilities outside of India report that India has not provided any 
information about scheduling audits  by BIS inspectors. We understand that COVID -19-related 
restrictions will likely prevent BIS inspectors from traveling internationally to conduct these audits 
for the foreseeable future. Consequently, it appears the QCO disproportionately impacts toys 
originating outside of India. The licensing process required to obtain a BIS mark is lengthy and US 
firms estimate it may take an additional four to six months after scheduled factory audits to complete 
the QCO requirements. According to industry, as a result of auditing delays, foreign manufacturers 
are unlikely to bring new toys to the Indian market in 2021. Will India consider alternative solutions, 
such as virtual audits or the use of recognized third -party certification companies in the country of 
manufact uring, in lieu of in -person audits by BIS inspectors?  
2.366.   The representative of China  provided the following statement. The current Toy Import Policy 
and the certification rules in the Quality Control Order (QCO) impose repeated testing and charges 
on the same  type of imported toys, which increases the economic burden and Customs clearance 
time of foreign manufacturers. According to the test price stipulated by the Bureau of Indian 
Standards BIS, sample testing (per sample) is charged about US$150, which means that the testing 
cost of a toy exported to India by a foreign toy manufacturer is about US$300. According to Article G/TBT/M/83  
 
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  5.1.2 of the TBT Agreement, China kindly requests India to delete the repeated testing and charging 
requirements in the QCO and DGFT Notifi cation No. 33/2015 -20, simplify c ustoms  clearance 
procedures and shorten customs clearance time. Considering the huge workload caused by the dual 
testing requirement of toy certification testing and import testing in a short time, it is  suggested 
that Indi a exempts imported toys from testing, enlarges the lists of third -party labs and accepts 
their testing results. Both the QCO and Import Policy require samples to be sent to NABL -accredited 
labs for testing or sampling. Among the 29 labs accredited by NABL at present, no more than ten 
labs can meet IS 9873 and IS15644 standards at the same time and operate normally, which is 
difficult to meet the huge dual testing requirements. According to Article 5.2.1 of the TBT Agreement, 
it is suggested that India exemp t the import toys with the Standard Mark from testing in a certain 
period of time, and enlarge the lists of third -party labs in Schedule -II of Indian Bureau of Standards 
(Conformity Assessment) Regulations 2018 which is stipulated in Article 3 of the QCO, to include 
NABL accredited labs and all ILAC -accredited labs, and accept the results of foreign labs accredited 
by ILAC. It is recommended that India cancels the factory's testing facilities requirements for all 
items such as electrical toys testing ones. As these testing facilities are relatively expensive and 
highly technically demanding, making it difficult for small and medium -sized enterprises. Besides 
these tests are usually completed by third -party labs outside. Requiring the factory of toys to set u p 
such facilities is unnecessary and unreasonable. It is recommended that India withdraws the factory 
testing facilities requirements for all items such as electrical toys, etc.  
2.367.   The representative of Canada  provided the following statement. Canada would li ke to 
reiterate its support for regulations of toys that are developed and implemented by WTO Members 
to protect the health and safety of children. Canada shared comments to India on the Quality Control 
Order for Toys on 6 April 2020, and we have yet to re ceive a response. Canada further outlined its 
concerns with the measure during the May 2020 TBT Committee written procedure (statement 
recorded in paragraph 1.84 of G/TBT/M/81 ). At the October 2020 TBT Committee meeting, Canada 
joined other WTO Members in seeking a further delay for th e implementation of the Order beyond 1 
January 2021. It is Canada's understanding that the Order did come into force on 1 January 2021, 
including its requirement that Indian officials conduct inspections of toy factories in exporting 
countries, at the expo rters cost. In the context of the global COVID -19 pandemic, with several 
countries – including Canada – maintaining travel restrictions and quarantine requirements, it is our 
understanding that it has become impossible for these inspections to occur and, c onsequently, 
imports of toy India have basically stopped. Further, India is not allowing foreign exporters to sell 
any stocks of toys that were already in India, because those toys do not have the certification. In 
order to provide a level playing field fo r imported toys and address what has clearly become a barrier 
to the trade in toys to India, Canada urges India to cease implementation of the Quality Control 
Order at least until the inspection of foreign toy production facilities can resume normally and be 
completed on a basis equivalent to inspections taking place in India. In addition, Canada reiterates 
its request that India respond to the comments it provided to India on 6 April 2020, through the 
Indian Enquiry Point.  
2.368.   In response, the representative o f India provided the following statement. Four months 
extension beyond 1 September 2020 was accepted to clear the inventories and get a licence from 
BIS. As per the packing and marking requirements of the Scheme of Inspection and Testing, 
Standard Mark sha ll be marked legibly and indelibly either on the primary package or on the toy 
itself. The material used for the marking should also conform to the specifications. The packing, 
marking, labelling, including warnings and other instructions shall be done as per the provisions of 
the Indian Standard. Besides, the model number and the following shall be incorporated on each 
package: (i) BIS Licence Number CM/L and (ii) BIS website details - Foreign inspection visits are on 
hold due to the prevalent restrictions on international travel due to COVID -19. Factory visits and 
inspections will be resumed once the restrictions are lifted. BIS has recognized a number of 
laboratories for carrying out toy testing as per various parts of IS 9873 and IS 15644 (Safety of 
Electrical Toys). All of these laboratories are currently running normally. The IS -wise list of 
recognized laboratories is dynamically updated and is available on the BIS website at the link  
below.81 
 
81 http://164.100.105.198:8096/bis_access/iswi se_v2.html   G/TBT/M/83  
 
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  2.1.3.46   India – FSSAI's Food Safety and Standards (Food Products Stan dards and Food 
Additives) Regulations, 2011 and the new implementing veterinary certificate for dairy 
products, G/SPS/N/IND/236  (ID 63382) 
2.369.   The representative of the European Union  provided the following statement. India has in 
December 2019 adopted a new veterinary import certifica te for milk and milk products based on 
Food Safety and Standards Regulation 2011, that is of great concern to the EU. The provisions of 
FSSAI's Regulation defines cheese as a "product produced from non -animal rennet or another 
suitable coagulating agent, w hich applies equally to both domestic and imported foods " (as reflected 
in the notification G/SPS/N/IND/236 ). It was however still possible for cheese containing animal 
rennet to access the Indian market provided that it was correctly labelled. The new veterinary 
certificate requir es 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 c heese by -products, 
such as whey and lactose. While the EU fully supports the importance of labelling the presence of 
animal rennet, the EU considers that this new certificate is not proportionate and not in line with the 
TBT Agreement. Veterinary certifica tes are to address sanitary (human or animal) health issues. 
There is no scientific evidence that cheese produced with animal rennet is harmful to health, or more 
harmful than cheese produced with artificial/vegetal rennet. We therefore would ask India to change 
the provisions of that veterinary certificate and allow for a label clearly indicating the presence of 
animal rennet in the cheese and its by -products, as it was previously the case. This label would allow 
consumers to make an informed choice.  
2.370.   The representative of the United States  provided the following statement. The United States 
appreciates the discussion related to India's market access requirements for dairy imports, and 
shares concerns with other Members that India's requirements may be more trade restrictive than 
necessary t o fulfil its legitimate objective. The United States is concerned that the India Certificate 
for Import of Milk and Milk Products into India contains the statement: "the source animals have 
never been fed with feeds produced from internal organs, blood mea l 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 o f ruminant origin present a sanitary or health risk. The 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 chee se 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.  
2.371.   In response, the representative of India provided the following statement. The provisio n of 
the use of non -animal rennet in the manufacture of cheese is not newly introduced. This provision 
has been existing in our Food Safety and Standards Regulations (FSSR) notified in 2011 and the 
erstwhile  Prevention of Food Adulteration Rules as well. D uring a recent revision of the milk and milk 
product standards in FSSR, these provisions were retained as such and continue to be a specified 
requirement regulation therein. The veterinary certificate for dairy products is primarily mandated 
by the Departm ent of Animal Husbandry and Dairying, Government of India. The Department has 
recently aligned the certification with our FSSR in respect of the prohibition on the use of animal 
rennet which otherwise was in contradiction to the provisions in FSSR and need ed to be corrected. 
Further, FSSAI has been lately asking importers of milk and milk products in India to furnish a copy 
of the veterinary certificate, already mandated by the Department of Animal Husbandry and 
Dairying, and hence it is not a new requireme nt introduced by FSSAI.  
2.1.3.47   India - Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65183) 
2.372.   The representative of the European Union  provided the following statement.  On 21 August 
2020 India issued an Order relating to the requirement of non -GM cum GM free certificate 
accompanied with imported food consignment, notified on 2 September 2020. This o rder originally 
should have entered into force on 1 January 2021 and has been postponed to 1 March 2021. The EU 
would like to highlight the following concerns. The basis for the list of 24 food crops in Annexure 1 
is not clear. The EU invites India to expl ain the rationale behind this list. Non -GM origin cum GM -
 
82 For previous statements follow the thread under ID 633. 
83 For previous statements follow the thread under ID 651. G/TBT/M/83  
 
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  free certification per consignment should not be required, at least for the listed crops for which no 
GMOs are authorized in the exporting country for food use. For the EU, this applies to 19 out of the 
24 crops listed in Annexure I. For these 19 crops, there is no authorization for GMOs in the EU. To 
avoid imposing an unnecessary administrative burden, the exporting country could provide a general 
non-GM origin statement to India on such crops. For l isted crops for which GM varieties are 
authorized in the exporting country (for the EU, this applies to maize, soybean, cotton, Argentin e 
canola , and sugar beet) a requirement to produce a certificate for every consignment is not justified. 
Such a burdenso me and expensive measure should only be imposed where recurrent non -
compliance has been established by official controls. To date, we have not received any information 
from India indicating that there have been identified instances of non -compliance with G M 
requirements by the EU.  
2.373.   India should explain why they consider it necessary to impose such a burden on trading 
partners with a high prevalence of non -GM food on their domestic market and a robust regulatory 
regime governing the use of GMs. The EU underli nes that in addition to the fact that only a limited 
number of the food crops referred to in the annexure are authorized to contain GMs, there are very 
strict traceability and labelling requirements applicable to food that is GM. This allows a strict and 
effective separation between non -GM and GM production. According to EU legislation, there is zero 
tolerance for unauthorized GM material in food. GM food authorized in the EU must be labelled as 
such, with the exception of authorized GM food in a proportion  less than 0.9%, provided the presence 
is adventitious or technically unavoidable. The EU as well as India are both parties to the Cartagena 
Protocol on biosafety to the Convention on Biological Diversity. To ensure coherent implementation 
of the Protocol,  the EU adopted Regulation 1946/2006 on transboundary movements of genetically 
modified organisms. According to Article 12(2) of this regulation, exporters of GMOs intended for 
direct use as food or feed or for processing must accompany their exports with a document stating 
that the export contains or consists of GMOs. This obligation for accompanying documentation of 
GMOs provides the necessary reassurance to the importers and to the authorities. Therefore, we 
consider that the additional certification of non-GM food is not needed and is unjustified. In 
conclusion, the Indian proposal, imposing non -GM origin cum GM free certification for all 
consignments of the listed crops, puts an additional burden and therefore costs on EU exporters 
(and their related fo od operators in the underlying supply chain). Given that the necessary 
assurances can be provided to the Indian authorities on the basis of existing documentation, these 
measures go beyond what is necessary to achieve the stated objective. Therefore, the E U considers 
the notified Order to be disproportionate and creating unjustified barriers to trade. The EU would be 
grateful if the above -mentioned comments could be taken into account and replied to. The EU also 
invites India to take immediate action to avo id any trade disruption and allow for a reasonable 
transitional period of at least one year since the entry into force of the new order.  
2.374.   The representative of the United States  provided the following statement. The United States 
continues to have serious c oncerns with India's measure 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 March 2021. 
While we appreciate In dia's notification of this measure to the TBT Committee and an extension of 
the entry into force date, 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. 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 
factors, such as costs of compliance, or potential trade disruptions. 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 the substantial uncertainty and the potential for significant 
disruptions to trade, we urge India to withdraw this measure to consider alternative approaches 
consistent with those of other Members to avoid creating unnecessary o bstacles to international 
trade. If India is unable to withdraw this measure, we request that India significantly delay 
implementation to allow for coordination with trade partners to develop less burdensome alternatives 
to the certificate requirement.  
2.375.   The representative of Brazil  provided the following statement. Since India has not provided 
any explanation on the points raised by Members regarding STC 651 in the last Committee meeting, 
Brazil would like to reiterate its remarks. Brazil strongly supports t he Indian commitment to ensuring 
high standards of health and safety for its population. However, we would like to express concerns 
related to its recent order setting requirements of non -GM cum GM -free certificates accompanied by G/TBT/M/83  
 
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  imported food consignment s, 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 individually. 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 i s 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 has India explained how this 
regulation relates to a ny relevant international standards for food safety and GMOs, differing from 
obligations set under Article 5.12 of the TBT Agreement. Said regulation might be already impacting 
Brazilian exporters. The Indian regulation is expected to be particularly harmf ul 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 consign ment 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 
the TBT Agreement and about its willingness to actually take into account timely submitted 
comments. Brazil urges India to reply to our timely submitted comments as soon as possible. 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 relevant international 
studies it relied upon in order to draft this regu lation?  
2.376.   The representative of Australia  provided the following statement. Australia thanks India for 
their ongoing engagement and cooperation regarding the use of Non -GM cum GM free certificates. 
Australia welcomed India's additional clarification provided  by the Food Safety and Standards 
Authority of India (FSSAI) on 12 October 2020, that the Order ( G/TBT/N/IND/168 ) relates to food 
crops only, and not to processed food products. Australia recognizes the right of the Indian 
Government to take measures necessary to ensure the safety and wholesomeness of food imported 
into India. However, Australia continues 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 m ore trade restrictive than necessary. Australia looks forward to 
India's continued engagement on this issue.  
2.377.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at the October 2020 TBT Committee Mee ting regarding India's non -GM 
import certification requirement which will come into effect on 1 March 2021. While we understand 
India's commitment to ensuring the health and safety of its population, it is unclear how India's non -
GM certification requireme nt will fulfil its intended objective given the lack of available scientific 
information and/or justification to support its implementation. As previously stated, robust, science -
based regulatory frameworks have been developed in countries around the world , including in 
Canada, to assess the risks of GM food products prior to their approval and commercialization. These 
products are authorized for commercialization only once they have received appropriate safety 
approvals. We remain concerned that the immine nt implementation of India's Order will 
disproportionately impact the ability of GM -producing countries to export to India and unnecessarily 
restrict international trade. To minimize potential trade disruptions, Canada respectfully requests 
that India dela y the imminent implementation of this measure to further engage with Members and 
take their concerns into account. In addition, we strongly encourage India to consider the scientific 
and technical information in its approach to support a transparent, predi ctable and fair trading 
environment. Lastly, we look forward to the responses to Canada's questions submitted through 
India's Enquiry Point in October 2020.  
2.378.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and su pports measures that focus on legitimate objectives, including the protection 
of human health and safety. However, New Zealand respectfully requests clarification from India 
regarding the specific intent and objective of the proposed measures. New Zealand remains 
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 Zeala nd 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 again 
notes the measures appear to be implemented under food safety legislation. If the protection of G/TBT/M/83  
 
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  human health is the objective, in whole or in part, can India advise whether they intend to also 
notify the proposed measures to the SPS Committee, given its relevanc e to provisions within the 
SPS Agreement, particularly Codex Alimentarius? New Zealand looks forward to receiving a response 
to the written submission made by New Zealand on India's notification G/TBT/N/IND/168 . 
2.379.   The representative of Japan  provided the following statement. Japan sh ares the concerns on 
India's proposed measure requiring "non-GM origin and GM free certificates " for 24 agricultural 
products imported to India, which 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 scientific 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 the crops 
whose d etection methods on GMOs have not been established and how to inspect such products at 
the border of India. Japan also would like India to clarify the necessity of the non -GM certificate if 
the production and importation of such GM crops are effectively pr ohibited in the exporting countries. 
Japan would like India to address the concerns raised by Member countries and reconsider the 
implementation of the proposed measures.  
2.380.   The representative of Chile provided the following statement. Chile thanks India for its 
notification on the "Order related to requirement of Non -GM cum GM free certificate accompanied 
with imported food consignment", communicated to the World Trade  Organization through 
Notification  G/TBT/N/IND/168 , and circ ulated on 2  September  2020. Chile reiterates its concern 
about the upcoming entry into force of the measure, and states that it looks forward to receiving a 
response to the comments submitted through the WTO TBT Enquiry Point, which were made last 
October.  
2.381.   The representative of Argentina  provided the following statement. Argentina would like to 
reiterate 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 certifi cate of Non -GM product origin, 
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.  We stress once again 
that scientific evidence shows that GM products are as safe as their conventional equivalents, have 
been marketed safely and harmlessly for decades and have undergone rigorous scientific 
examination to prove so. Hence, there is no scientific justification for discriminating between one or 
the other . We hope th at India will amend the notified Order so as not to create unnecessary barriers 
to international trade. We recall that we have already submitted more detailed comments and 
specific questions through India's TBT Focal Point and hope that they will be review ed by the Indian 
authorities in order to safeguard the normal flow of trade in agri -food products.  
2.382.   The representative of Colombia  provided the following statement.  Colombia wishes to 
support the trade concern raised by Brazil and the United States regardin g the Order adopted on 
12 October  2020 by the Food Safety and Standards Authority of India (FSSAI), which is part of the 
country's Ministry 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 national authority of the exporting 
country.  We reiterate our concern about this measure, which we consider could limit export s of 
certain fresh fruits and vegetables to that market.  From the information provided by India, there is 
no clarity with respect to the legitimate objective pursued by India, its scope, products covered or 
the requirements for market access. Similarly, th e scientific evidence on which these new 
requirements would be based is also not known.  Account should be taken of the fact that 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 Ag reement, which states that,  "(...) Members shall ensure that technical regulations are not 
prepared, adopted or applied with a view to or with the effect of creatin g unnecessary obstacles to 
international trade".  
2.383.   Although we have learned that the entry into force of this regulation was postponed from 
January  2021 to 1  March this year, we would like to reiterate that Article  2.12 of the TBT  Agreement 
provides that, "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 ad apt 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 G/TBT/M/83  
 
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  documentary adjustme nts to implement a new procedure for the issuance of GMO -free certificates, 
which will certainly incur an additional cost for exporters, a situation that generates uncertainty and 
possible significant disruptions to trade. Such a situation creates uncertai nty and possible major 
disruptions to trade.  We request India to revise this regulation, extend implementation times and 
consider alternative ways to avoid the creation of unnecessary obstacles to international trad e. 
2.384.   The representative of Paraguay  provide d the following statement. Paraguay wishes to 
support the trade concern raised by the European Union, the United States , Brazil, Australia, Canad a, 
New Zealand and Japan regarding the 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 origin , 
which was notified in document G/TBT/N/IND/168 . The entry into force of this Order  was originally 
planned for 1 January 2021, but has been postponed until 1 March  2021.  This regulation applies to 
24 crops , for which an  official certificat e must be submitted attesting that the imported products 
have not been genetically modified . In this connection, and taking into account the statements and 
concerns of other Members, we have been unable to identify t he criteria used by India to select 
these 24 crops and further clarification is therefore required . We also agree with other Members' 
comments regarding the fact that India has not submitted or identified  any regulatory impact 
assessment , scientific eviden ce or risk analysis  on which the measure is based . Furthermore , we 
have not found any technical justification providing the reason for which a certificate is to be 
submitted for each consignment. This would place costly additional burdens on exporting firm s. 
2.385.   Paraguay is of the view that India's measure could affect Paraguayan producers' potential 
trade, since the Order lays down unnecessarily cumbersome requirements . In this regard, it should 
be highlighted that the measure to be imposed by India is inconsi stent with Article 2.2 of the TBT 
Agreement, which specifies 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 pur pose, technical regulations shall not be more trade -restrictive than necessary to 
fulfil a legitimate objective, taking account of the risks non -fulfilment would create. Such legitimate 
objectives are, inter alia : national security requirements; the preven tion of deceptive practices; 
protection of human health or safety, animal or plant life or health, or the environment. In assessing 
such risks, relevant elements of consideration are, inter alia : available scientific and technical 
information, related proc essing technology or intended end -uses of products ". Moreover , 
international standards established under the Codex Alimentarius  Commission lay down guidelines 
to support the conducting of food safety assessments for GM products and allow for the growing and 
trading of GM products that, once authorized, are considered equally as safe and nutritional as their 
conventional counterpar ts. 
2.386.   We are also concerned that this measure may create the unjustified assumption that GM 
food products are inherently less safe than non -GM food products , despite the fact that GM products 
have been assessed and authorized through sound regulatory process es and have undergone 
rigorous scientific safety assessments in accordance with international standards, guidelines and 
recommendations, in order to ensure that they are considered equally as safe as their conventional 
counterparts . In January, Paraguay , together with other Members,  sent a note outlining the above -
mentioned concerns to the Government of India. We look forward to an examination of and response 
on the matter . In light of the above , Paraguay is of the view that the regulation notified in 
G/TBT/N/IND/168  could be more t rade-restrictive than necessary to fulfil any legitimate objective 
under the TBT Agreement and therefore requests that India reconsider the measure . 
2.387.   The representative of Uruguay  provided the following statement. Uruguay would like to 
thank the delegations  of the United  States  of America, Brazil and the European  Union for including 
this concern on the Committee's agenda.  As recalled by the delegations of Argentina and Paraguay, 
there is consensus internationally that genetically modified products, approved by exporting 
countries on the basis of Codex recommendations, in relation to the risk assessment methodology, 
are equivalent to their conventional counterparts.  Uruguay therefore considers that there is no 
apparent technical justification for the implement ation of the certification measure  proposed  by 
India, taking into account the legitimate objective, cited in the Order in question, of ensuring  the 
safety and wholesomeness of imported food.  While we note the extension of the proposed date of 
entry into fo rce of the measure until 1  March, we wish to stress the importance for Members to 
establish  measures based on scientific principles, and particularly to ensure that such measures are 
applied with the  objective of minimizing negative trade effects , in line with the provisions of the TBT 
and SPS  Agreements.  We remain attentive to the comments made by the delegation of India in 
response to Members' concerns.  G/TBT/M/83  
 
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  2.388.   In response, the representative of India provided the following statement. It may be noted, 
the Genetic  Engineering Appraisal Committee (GEAC) is a statutory body under the "Rules for the 
Manufacture, Use /Import /Export and Storage of Hazardous Microorganisms/Genetically 
Engineering Organisms or Cells, 1989" notified under the Environment (Protection) Act,  1986. This 
Committee is empowered to approve proposals relating to the release of genetically engineered 
organisms and products into the environment. The Committee has so far not approved any of the 
crop varieties of Genetically Modified/Engineered origin  listed in the above -mentioned Order. In 
pursuance of the above, FSSAI is only seeking a certificate from exporting country to ascertain the 
GM-free status of listed crops. Further, FSSAI has clarified the non -applicability of this requirement 
for the impo rt of processed food vide letter dated 12 October 2020 (Q 37 of TPR).  
2.1.3.48   Russian Federation - Federal Law n° 468 on wine making and wine growing in 
the Russian Federation (ID 65084) 
2.389.   The representative of the European Union  provided the following statement. Ru ssia has 
adopted a measure "Federal Law Nº 468 of 27 December 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, only six months after its adoption, de spite requests to postpone this date. 
Amendments to the law (the so -called Bakharev proposal) are being considered by the Duma where 
the discussion appears to be delayed. This Federal law contains several provisions that amount to 
obstacles for the importa tion of wine and wine -based products into the Russian Federation territory 
- regarding wine based products; Geographical indications; discrepancies between the Law and OIV 
provisions and the differences with EAEU Technical Regulation. The EU is very concer ned that the 
Law will have a strong impact on import of foreign wines. In this context, the EU would like to ensure 
that enriching wine with concentrated grape must or rectified concentrated grape must or sucrose 
to attain a higher alcohol content level is  an authorised (oenological) practice for imported 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 sector. The EU has been 
informed by three EU member States (France, Italy, Spain) that they recently received a letter from 
Rosselkhoznadzor asking to provide extraordinary detailed information on every wine production 
facility exporting to Russia. In addition, the same letter refer s to the legal right to carry out inspection 
missions. The EU sees this new measure with concern and would like to request clarification on a 
series of issues raised by this letter and would be grateful if Russia could answer the following 
questions.  
2.390.   What is the rationale for requesting the amount of information requested in the letter? Could 
Russia explain the rationale for carrying out inspections of producing facilities? The EU would like to 
underline that wine is not a risky product as regard sanitary h azards and to invite Russia to adopt a 
balanced approach in terms of inspections systems to avoid unnecessary disruption of international 
trade. In addition, wine is produced in the EU under a very comprehensive legislation which is to a 
large extent harmo nized at EU level and which is compliant with the international standards from 
the International Organisation of Vine and Wine and the Codex Alimentarius. Has Russia the intention 
to notify to the World Trade Organization any new measure having an impact o n international food 
trade? Also important is to highlight that this kind of request should also be sent to the relevant EU 
institutions. In addition to the issues posed by the Federal law itself, some of its requirements do 
not coincide, or even contradic t, with the technical requirements set out in the EAEU TR on safety 
of alcohol products, contributing to regulatory uncertainty. We understand that the date of 
implementation of the TR has been postponed by one year to allow some additional harmonisation 
work with the Russian Law, while amendments to the Russian Law are being considered at the Duma. 
This harmonisation phase would also be a good opportunity to correct also divergences with the 
international standards produced by OIV. Lastly, it seems that th e Federal Law also contains 
provisions covered by the Agreement on trade -related aspects of intellectual property rights. The EU 
would like to invite Russia to notify the measure to the Council for TRIPS. The EU invites Russia to 
notify the new wine measur e, under the TBT Agreement as well as under the TRIPS Agreement. 
Meanwhile, the European Union would like to ask Russia to take these comments into consideration 
during the ongoing amendments' procedure.  
2.391.   The representative of the United States  provided the  following statement. The United States 
supports the request for Russia to notify implementing measures to the WTO TBT Committee, 
provide at least 60 days for interested stakeholders to comment on the measure, and take submitted 
 
84 For previous statements follow the thread under ID 650. G/TBT/M/83  
 
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  comments into account befor e finalizing the measures. The United States also seeks a response to 
our comments on Federal Law n° 468 submitted to Russia's WTO TBT Enquiry Point in August 2020.  
2.392.   The representative of Australia  provided the following statement. Australia understands 
Russia has adopted "Federal Law Nº 468 of 27 December 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 International 
Organisation of Vine and Win e (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 harvest 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 ageing 
process, Article 18 includes a category refe rred 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.  
2.393.   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 a dditions of water aids fermentation during periods of difficult 
seasonal conditions, including drought. Russia's Federal wine law includes provisions covered by the 
Agreement on Trade -related Aspects of Intellectual Property Rights (TRIPS), including geogr aphical 
indications. 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 0 47/2018 "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 
encourage s 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.  
2.394.   The representative of Argentina  provided the following statement . Argentina would like to 
highlight its concern regarding the implementation of Federal Law No.  468 on wine making and wine 
growing in the Russian Federation. We are particularly concerned about possible restrictions that the 
new Law could impose on import s of "bulk wine", as, although such imports are permitted, "bulk 
wine" is considered "wine material" and the product cannot be called "wine" once it has been divided 
up and packaged, even if it is only packaged and does not undergo any other organic proces s or 
procedure and is not blended with other beverages or substances.  We trust that through constructive 
dialogue with stakeholders, appropriate amendments can be made to the standard in order to avoid 
unnecessary trade disruption.  
2.395.   In response, the represe ntative of the Russian Federation  provided the following statement. 
Russia took note of the statements made by the delegations of the EU, the US and Australia. For the 
time being, in response we would like to state the following. The Federal Law on winemak ing and 
winegrowing entered into force on 26 June 2020. The Law is aimed to develop and improve Russian 
internal market, it sets requirements both for domestic and foreign winemakers irrespective of their 
origin. The provisions of the Federal Law are elabo rated taking into account the obligations of the 
Russian Federation in the WTO and other international organizations. Preliminary available results 
of the year show that entry into force of the Law did not lead to substantial decline in imports. 
Specifical ly, wine import value for 11 months of 2020 as compared to the same period of 2019 from 
Australia increased by 4%, from the EU decreased by 5%, from the United States increased by 22%. 
This is quite good performance in the pandemic year. To put these numbe rs into context, import 
value to Russia of all products for the same period from the world fell by 6%, from the European 
Union by 8%, from Australia by 4%, from the US by 1%. As for the TRIPS Agreement, we stress 
that this Law does not cover intellectual p roperty rights (IPR) and does not set the legal environment 
for protection of IPR. In the Russian Federation intellectual property rights are registered and 
protected under the Civil Code of Russia that is based, inter alia , on Russia's obligations under t he 
TRIPS Agreement.  G/TBT/M/83  
 
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  2.1.3.49   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  (ID 66285) 
2.396.   The representative of the United States  provided the following statement. • The United 
State s thanks Panama for delaying implementation of its potato measure for another six months. 
Additionally, we thank Panama for allowing U.S. onion exporters to show letters from their packers 
as evidence of compliance with the harvest date requirement. Under the US -Panama Trade 
Promotion Agreement, Panama has grown into an important market for US onion exporters. 
Unfortunately, Panama's storage criteria, harvest date requirements, and sprouting limits continue 
to harm US onion exports and will soon harm US pot ato exports. The United States is frustrated by 
Panama's lack of transparency around these two measures. We submitted comments to both of 
Panama's notifications, but Panama has yet to reply to our comments, provide scientific or technical 
justification for  its measures, or provide a follow -up response to our concerns raised in our 
intervention at the October 2020 TBT Committee. Onions and potatoes produced in the United States 
can be marketed for close to a year after harvest due to quality seed, variety se lection, good supply 
chain practices, cold storage, and other technologies. The relevant Codex  standard specifically 
excludes fruits and vegetables from "use-by date " or "best-before date " labelling requirements and 
Panama has not provided a justification for its deviation from Codex standards. Regarding the zero -
sprouting tolerance, we again note that this requirement is unnecessary and is not commercially 
viable. Industry standards provid e consumers with high -quality produce, and consumers ultimately 
choose whether they want to purchase any individual onion or potato. Importantly, there are also 
no demonstrated food safety concerns regarding sprouting. We also note Panama appears tsio be 
applying stem and bulb nematode testing to protect plant heath and, as such, we request that 
Panama notify this measure to the SPS Committee. Given the above, we request that Panama 
suspend implementation of both measures indefinitely and work with trading partners, including the 
United States, to address its TBT and SPS concerns in a manner that facilitates safe trade.  
2.397.   The representative of the European Union  provided the following statement. We join the 
trade concerns voiced by the US. Our EU exporters are  also facing similar difficulties in agricultural 
trade with Panama. The European Union would like to stress the importance of speedy, consistent 
and transparent SPS procedures carried out by independent authorities  and the need to avoid  
unnecessary barrie rs to trade. The EU is prepared to work bilaterally with Panama to find a 
satisfactory solution.  
2.398.   In response, the representative of Panama  provided the following statement. The delegation 
of Panama thanks the United States of America and the European Union  for their comments. It i s 
our understanding t hat our capitals are working bilaterally to address this trade concern, and we 
hope that we will soon find a solution that we will be able to share with this Committee. We welcome 
your comments, which we will f orward to our authorities . 
2.1.3.50   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 65986) 
2.399.   The representative of Australia  provided the following statement. Australia understands that, 
following the end of the Brexi t transition period, the UK has rolled over existing EU wine laws and 
regulations. As the EU would be aware, this means that from 1 January 2021, wine imported into in 
the UK, either in bulk or in bottles, and sold in the UK now requires the name and addre ss of a UK -
based importer on the label. We understand that this was the same as the requirement that 
previously applied, 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 wo uld be logical to give details of both EU and UK 
importers on a single label to ensure trade can continue uninterrupted and without additional 
expense to wine producers. Under EU regulation, we understand that an indication of the "importer" 
is compulsory for wine imported into the EU (under Regulation No. 1308/2013 and Delegated 
Regulation 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 the wine into circulation in the EU, and not 
misleading consumers.  
 
85 For previous statements follow the thread under ID 662. 
86 For previous statements follow the thread under ID 659. G/TBT/M/83  
 
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  2.400.   However, we are seeking assurance from the EU that its labelling requirements are no more 
trade restrictive tha n necessary to achieve their objectives. We believe that the EU allowing an 
'optional 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:". We are also seeking clarity 
from the EU on whether it is possible to list importers for multiple destinations on the same wine 
bottle label under current EU R egulation. Further guidance and clarity are important to provide 
certainty to traders and ensure no interruptions to trade occur. We look forward to working closely 
with the EU on this issue to ensure a mutually satisfactory outcome as we continue similar 
discussions with the UK to resolve this issue for wine imported into the UK.  
2.401.   In response, the representative of the European Union  provided the following statement. As 
explained in the previous TBT Committee, the indication of the "importer" is a compulsor y 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 before 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 person a ssuming responsibility for bringing the wine into circulation in the EU).  
2.1.3.51   European Union - Waste Framework Directive, G/TBT/N/EU/778  (ID 65887) 
2.402.   The representative of India provided the following statement. New obligations (with cost 
implications) for Indian exporters to meet the exte nded database requirements for SCIP under Waste 
Framework Directive. This STC was raised in the last TBT meeting with a request to defer the 
measure for a year. But the EU has rolled out the measure. Brief background: the EU revised its 
Waste Framework Dir ective (WFD) in July 2018. This revision was in alliance with the EU's principle 
of the circular economy. It enables EU to recycle and reuse the materials, thereby gradually 
decreasing the imports of raw materials. As per the amendment to the WFD, the ECHA  is mandated 
to establish a new database on the list of hazardous chemicals present in articles by 2019. Such a 
database will serve as a source of information for waste treatment operators and consumers. The 
range/degree of hazardous nature of chemical sub stances listed in the database would enable the 
waste treatment operators to treat and recycle waste materials accordingly. This system is designed 
to make the information available throughout the chemical substances' lifecycle to manage and 
navigate the r isk nature of chemical substances during waste collection, recycling, and reuse. This 
database would also enable the consumers to make an informed decision in their purchase of various 
products. In other words, through this measure, the EU is intending to exert pressure on the use of 
hazardous chemical substances and move towards substituting them with non -toxic substances.  
2.403.   SCIP Database: SCIP stands for Substances of Concern In articles or complex objects 
(Products). It is a database of articles (products)  containing substances of very high concern 
(SVHCs) from the Candidate List (to be noted, this candidate list is maintained under the REACH). 
It has information on articles that includes Candidate List substances in quantities of more than 
0.1% of their we ight. As per the WFD requirement for the database, the business operators 
(producers, assemblers, distributors, retailers and importers) must submit the details on the 
products, including company data, Candidate List substance data, article description and  safe use 
instructions of the Article to the ECHA. The EU mentions that such information is already submitted 
by the business operators under the REACH. Since REACH regulation's applicability covers multiple 
sectors covering chemicals, textile, electrical,  electronic, leather, plastics, packaging, paints, dyes, 
varnishes, etc., such sectors are required to become a part of this database. The ECHA has 
established a database on 5 January 2020, and the operators must submit information from 5 
January 2021. As a result, the business operators must submit data from 2021 concerning 
information on articles, the name, concentration range, and location of SVHC in the Article, and 
other information on the safe use of the Article. The business operators must mention su ch details 
only if their products contain chemical substances listed in the Candidate List . ECHA reports that it 
is working to reduce the industry's administrative burden in submitting such details. The database 
was launched on 28 October 2020.  
2.404.   Concerns: a) Waste Directive 2018 and REACH : Obligation: REACH defines the recipient of 
an article as "an industrial or professional user, or a distributor, being supplied with an article but 
 
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  does not include consumers". Therefore, Article 33(1) of REACH imposes an o bligation to 
communicate certain information about the substances of very high concern (SVHC) in the article to 
the recipient entity in the supply chain. The Waste Directive 2018, Article 9 now requires this same 
information to be notified to the ECHA as w ell. Impact/Analysis: It may be noted that REACH Article 
7(2) already has an existing duty for producers and importers of articles containing Candidate List 
substances to notify the ECHA, but only if they are present in articles above one tonne per legal 
entity per year. However, as per the new directive, manufacturers and importers who are placing 
less than 1 -tonne quantity of the article  in the EU market are also obligated to notify ECHA 
information regarding SVHC.  
2.405.   b) The Obligations under the Waste Dire ctive 2018 : Obligation: The obligation to notify the 
requested information about SVHC under Waste Directive 2018 is on "suppliers of an article". REACH 
allows direct submissions and notification to the ECHA only by EU -based producers, importers, etc. 
Non-EU producers, distributors, and other suppliers must appoint an "only representative or OR" 
responsible for communicating information to the ECHA. Impact/Analysis: Article 7(2) of the REACH 
already requires all manufacturers and importers of articles (in qu antities greater than 1 tonne 
annually) containing SVHCs to notify information about the Article to the ECHA through ORs. 
Therefore, all such manufacturers and exporters of articles who are not based in the EU will already 
have contracted with ORs based in  the EU for liaising with the ECHA. Thus the obligation to engage 
new ORs will fall only on non -EU (a) manufacturers and importers who are placing less than 1 -tonne 
quantity of the Article in the EU market, and (b) other suppliers such as wholesale distrib utors of 
the articles. The new directive imposes notification obligation on other entities in the supply chain, 
such as distributors and other actors. This will create duplicity of obligations as manufacturers may 
have already provided such information via  their ORs to ECHA. Requiring distributors to repeat such 
a process will add to the costs and administrative burden. 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 manufacturers 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. Apart from adding to th e costs, this requirement also acts as a barrier 
to trade for non -EU countries. This measure became too cost -intensive in case export quantities of 
SVHCs are less than one tonne per annum.  
2.406.   c) Confidential Business Information : As per Article 9 of the WFD, the ECHA may provide 
access to the database to the consumers upon request other than the waste operators. Regarding 
data confidentiality, as it concerns business information, there is no specific mention in the WFD. 
Hence, consumers' accessibility for info rmation under this clause is a concern to business operators. 
However, the ECHA has mentioned that it will ensure protection in cases where it is justifiable. If 
the links are established between parties in the supply chain, such information may not be ava ilable 
to the public. But, there is no mention of protection of such information from being available between 
businesses. d) Implementation Concerns : The WFD does not elaborate on how the Article and 0.1% 
will be evaluated, whether as a percent of the enti re product or the component. We seek clarification 
from the EU on this. Testing / extracting a representative sample may be very difficult, especially 
when the SVHC is in the coating, surface treatment, paint, etc. In such cases, one can end up with 
an ove restimation of the SVHC contents. Last TBT Committee meeting: This issue was raised in the 
last TBT Committee meeting in November 2020 by India and was supported by Canada and the US. 
China had also raised a similar issue on the SCIP database. India has re quested EU to notify the 
measure to WTO and defer the implementation of the regulation until the comments are received 
and taken into consideration. The EU though notified its amended measure on Waste Directive at 
the WTO via G/TBT/N/EU/778  dated 3 February 2021 but did not wait to r eceive the comments. EU 
has implemented the database. China, the US, and Canada requested to delay the database's 
implementation by one year. The database was rolled out on 28 October 2020, giving the industry 
very little time to assess, prepare, and input  the information in the SCIP Database. Conclusion: In 
view of the above, the EU. is requested to hold back the implementation of the measure till it receives 
comments from the stakeholders. Further: (i) EU is requested to share the risk assessment for 
removing the quantity barrier; (ii) how EU proposes to protect access to data between businesses; 
(iii) request EU to clarify the implementation issues raised.  
2.407.   In response, the representative of the European Union  provided the following statement. 
The EU would  like to thank India for the continued interest in the SCIP database for information on 
Substances of Concern In articles or in Products, established under the Waste Framework Directive 
(WFD). The European Union would like to inform WTO Members that the ob ligations with regard to 
the information on substances of very high concern in articles and products to be provided to the G/TBT/M/83  
 
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  European Chemical Agency through the SCIP database entered into application on 5 January 2021. 
The European Union notified the final text of the Waste Framework Directive under the TBT 
Agreement, for transparency purposes, under reference G/TBT/N/EU/778 . Regarding the question 
from India about the protection of commercial interests, the EU would like to note that the 
information in the SCIP database will be public and therefore readily available to consumers and to 
waste operators to bridge the current gap in the inform ation flow from supply chains to these 
operators when articles and products reach the waste stage. The information in the SCIP database 
covers only articles containing substances of very high concern (SVHCs) on the Candidate List and 
not all components of a product (or complex object). Such information must already be 
communicated down the supply chain under REACH Article 33(1) and to consumers upon request 
under REACH Article 33(2) in order to ensure the safe use of articles placed on the EU market. The 
SCIP database therefore complements the existing communication and notification obligations for 
Candidate List substances in articles under Articles 33 and 7(2) of REACH, and should reinforce 
compliance with them.  
2.408.   ECHA has implemented several measures to ens ure the protection of the commercial 
interests of submitters for the information submitted to ECHA in SCIP notifications, in particular 
information that could reveal links between actors in the supply chain. Those measures focused both 
on the information r equested to be submitted (information requirements) and on the public 
dissemination of the data submitted to ECHA. The information requirements for SCIP notifications 
include some measures to avoid the submission of information that could undermine commerc ial 
interests, for example, no details are requested concerning the chemical composition of articles. It 
is only required to provide the identification of the main material the article is made of and the 
Candidate List substance present in that article, as  well as its concentration range in the article. 
Concerning the identification of the article, it is only required to provide its identification as it 
appears, for instance, in labels and catalogues and by identifying the function or use of the article 
(article category) by selecting an article category from pre -defined list based on the Combined 
Nomenclature (CN) and TARIC lists. ECHA has also provided advice on "grouping" quasi -identical 
articles and complex objects (products), as well as on simplifying t he "hierarchy" of components and 
subcomponents in a notified product to allow the determination of the "location" of the article 
containing a Candidate List substance within the product.  
2.409.   Concerning the dissemination of data to be made publicly available, i n order to avoid the 
establishment of links between actors in the supply chain by any means from that data, the following 
information is not made available: the identity of the submitters (duty holders); specific names (e.g. 
brand, model) or (alphanumeric or numeric) identifiers of components in complex objects (or 
products). All other information submitted to ECHA is published as received on the ECHA website. 
We invite you to consult "Dissemination and confidentiality in the SCIP Database " document which 
further elaborates these aspects. The quality and accuracy of the submitted data always remains 
under the responsibility of each submitter, as well as the responsibility of not submitting any data 
that may be considered to undermine their commercial interes ts. On this regard, ECHA strongly 
encourages submitters to simplify their SCIP notifications by submitting only relevant data in a clear 
and understandable manner for waste operators and consumers by following the recommendations 
included in the user manua l "Requirements for SCIP Notifications " and in the "Key tips for successful 
SCIP notifications ". 
2.410.   In conclusion, the measures implemented by ECHA to ensure the protection of the 
commercial interests of submitters addresses the information available to consu mers, waste 
operators and between businesses. With regard to the question about the relationship between the 
notification under REACH Article 7(2) and the SCIP notification, the EU recalls that these notifications 
have different objectives. The former aims  at providing ECHA and the member State competent 
authorities with information which may be used to identify a need for initiating regulatory risk 
management procedure under REACH (authorization and restriction) or under other EU legislation, 
while the lat ter aims at the availability of information on articles containing Candidate List substances 
throughout the whole lifecycle of products and materials, including at the waste stage. The REACH 
Article 7(2) tonnage threshold (one tonne per legal entity per ye ar) covers all articles containing a 
specific Candidate List substance in a concentration above 0.1% within the portfolio of a producer 
and/or importer. The notification obligation under that provision has also two important specific 
exemptions (REACH Art.  7(3) and 7(6)). Furthermore, the information required (REACH Art. 7(4)) 
to be submitted to ECHA under REACH Art. 7(2) is not intended to achieve the same objectives as 
the SCIP notifications. Therefore, these information obligations are complementary. The  European 
Union would like to refer to the statement from the October 2020 TBT Committee for more G/TBT/M/83  
 
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  information and remains available to provide replies with regard to the SCIP database to interested 
Members.  
2.1.3.52   France - New legislative requirements about index  of repairability of electrical 
and electronic equipment, G/TBT/N/FRA/195 , G/TBT/N/FRA/196 , G/TBT/N/FRA/197 , 
G/TBT/N/FRA/198 , G/TB T/N/FRA/199 , G/TBT/N/FRA/2 00, G/TBT/N/FRA/201 , 
G/TBT/N/FRA/202 , G/TBT/N/FRA/203  (ID 65788) 
2.411.   The represent ative of China  provided the following statement. According to Articles 2.2 and 
2.12 of the TBT Agreement, it is proposed to postpone the implementation of article L541 -9-2 of 
environmental law to 2022. The reasons are as follows : (a) These requirements for  the establishment 
and mandatory display of repairability index of electrical and electronic equipment are the first in 
the world, and there is no previous experience for reference. In addition, there are only two days 
between the date of entry into force and the final date for comments. It is too short for most 
enterprises, including Chinese enterprises to carry out implementation works. (b) Compared with 
traditional CE and energy efficiency labels, the evaluation of the repairability index mostly depends 
on the commitment of enterprises. The commitment requests the cooperation between departments 
to re -evaluate the enterprise's ability, potential risks, as well as to modify and print the 
corresponding documents afterward. A complex assessment process with communication and 
cooperation between departments requests more time to achieve compliance. (c) For many 
companies, especially a large number of small and medium -sized manufacturers outside of France, 
the implementation of the new regulations requests resh aping after -sales channels. Both self -built 
after-sales channels and professional repairers pointed as after-sales partners cost much time. 
Especially at present, the impact of COVID -19 has caused global supply chains and logistics chains 
to be blocked. So ，the manufacturers face difficulties in compliance rectifications with the new 
decree.  
2.412.   It is proposed to add supplementary clauses on the date of entry into force of each category 
of equipment. At present, only orders relating to the criteria, sub -criteria , and scoring system for 
repairability index calculation and display of washing machines, smartphones, laptops, televisions, 
and electric lawn mowers (batteries, cables, and robots) have been released. The requirements for 
other electrical and electronic e quipment products are still not clear. This causes great compliance 
difficulties for manufacturers. It is not consistent with Article 2.12 of the TBT Agreement. It is 
recommended to add a supplementary clause: "The date of entry into force of each category  of 
equipment is determined by its specific 'criteria, sub -criteria and scoring system for the repairability 
index calculation and display.'"  China suggests France amend Article 1 R. 544 -3 to be consistent 
with other laws and regulations. To be specific, t he new decree would apply to products placed on 
the market after the decree entry into force, rather than products already on sale. China suggests 
France clarify the relevant law enforcement entities and responsibilities, as well as the customs 
clearance a nd market supervision of products in France before the penalty clause entries into force 
on 1 January 2022. It is proposed to refine the conformity assessment method and market 
supervision scheme as soon as possible, and issue relevant guidelines.  
2.413.   In respo nse, the representative of the European Union  provided the following statement. 
Thank you to the delegation of China for its comments on new legislative requirements about index 
of reparability of electrical and electronic equipment of France. France has n otified 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. 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 on 1 January 2021 of the provisions provided for in Article 16 relating to the 
implementation of a reparability index on electrical and electronic equipment. As according to th e 
law, the repairability index entered into force on 1 January 2021 starting with the following products: 
front-loading washing machines, smartphones, laptops, TV monitors, electric lawn mowers (three 
types: with electric cable, with battery, robot). 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. Thi s provision 
reflects the consideration of the need for economic actors for an adaptation period for the 
deployment of the measure in the first year of implementation. You can find more information on 
 
88 For previous statements follow the thread under ID 657. G/TBT/M/83  
 
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  the website of the Ministry for ecological transition89 (the following documents are also available in 
English: manual, calculation grid, and the graphic charter).  
2.1.3.53   Chile - Technical specifications for the design of energy efficiency labels for 
washing machines, G/TBT/N/CHL/297 , G/TBT/N/CHL/325  (ID 65490) 
2.414.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of Chile to protect the environment and Korean companies are fully committed to 
complying with the regulations of Chile. At the time of notification in 2015, there was no need to 
submit opinions, but as the Korean companies are having difficulties complying with Chilean washing 
machine energy -efficiency label regula tions, Korea would like to make some comments regarding 
this regulation as follow. At the 3rd WTO TBT Committee in 2020, the Chilean delegation replied that 
the comments of the Korean delegation on tolerance of energy efficiency labels for washing machine 
would be delivered to the Chilean Ministry of Energy in order to provide a proper reply. However, 
since there has not been a reply yet, Korea would like to enquire about whether the comments of 
Korea have been delivered to and under review process by the M inistry of Energy. If the review has 
not yet been conducted, Korea would like to kindly request that our comments be delivered to the 
Chilean Ministry of Energy again for review and proper reply.  
2.415.   In response, the representative of Chile provided the follow ing statement. Chile thanks the 
Republic of Korea for its submission to this Committee regarding notifications G/TBT/N/CHL/297  and 
G/TBT/N/CHL/325 . Chile wishes to report that Law No.  21.305 on energy efficiency was published 
on 13  February  2021, on which the Ministry of Energy worked closely with the Natio nal Congress 
and other ministries recently involved in regulations.  The implementation of energy efficiency  
measures is an important public policy for Chile, given the many benefits it provides: it leads to 
reduced household energy spending, global and loc al pollutant emissions and international market 
energy dependency, limits land use for energy infrastructure, and increases the country's 
productivity by reducing production costs associated with energy consumption, which is also 
reflected in an increase i n national energy security.  The Chilean Ministry of Energy has prioritized its 
work on the recently established Regulation, and would like to inform the Korean delegation that it 
hopes to be able to respond in the near future to the requests about the ener gy efficiency of washing 
machines, which would require amendments. Stakeholders should be invited to participate in a 
national and international public consultation process on this matter soon.  
2.1.3.54   Republic of Korea - Revision of Safety Conformation Criteria f or Textile Products 
for Infants , G/TBT/N/KOR/678  (ID 65291) 
2.416.   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 201 8, Korea introduced new safety requirements for infant clothing, 
which changed the testing and certification procedures of these products. The EU believes that the 
extra testing is more trade restrictive  than necessary to fulfil a legitimate objective thus  not in line 
with Article 2.2 of the TBT Agreement. 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. Consequ ently, testing and certification costs have 
increased substantially for European producers. As an example, the total testing costs for infant 
clothing of an EU producer increased by 287% in 2018 compared to 2017 whilst the sales of 
children's clothing in K orea increased by only 1.5% over this period. Similarly, the testing costs in 
2019 were 284% higher than 2017 whereas sales increased by only 12% over this period. The main 
issue is that Korea's testing procedure requires a huge amount of samples to be sen t to Korea for 
testing. To our knowledge, Korea is the only country that requires in -country lab testing for these 
products. Other countries either recognize international standards or allow the testing to be 
performed by an internationally accredited labo ratory that carries out tests according to specific 
standards. In an effort to facilitate the customs procedures, EU industry has submitted applications 
for their recognition as a "best practice company" to the Korea Customs Service (KCS). However, at 
the end of 2020, EU industry was informed by KCS that their applications could not be completed 
due to a lack of input from the KATS. We would appreciate an update in this regard. The EU has had 
 
89 https://www.ecologie.gouv.fr/indice -reparabilite   
90 For previous statements follow the thread under ID 654. 
91 For previous statements follow the thread under ID 652. G/TBT/M/83  
 
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  multiple meetings with the relevant Korean authorities to address  these issues and would therefore 
kindly request that the Korean authorities take the necessary steps to remove this trade barrier.  
2.417.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to take this opp ortunity to respond to the issue regarding South Korea's 
requirements for Textile Products for Infants, which was raised by the EU at this TBT committee. 
The EU has raised concerns regarding specific textile products used by or for infants under 36 months 
of age. Specifically, the EU believes that infant clothing is not a hazardous product, and that the 
requirements are therefore too strict. However, a risk assessment on textile products for infants in 
Korea found that such a risk was in fact very high for infants, especially due to injuries caused by 
strings, cords, harmful substances, and others. In this vein, the safety of infant clothing products 
must be verified through product inspections with a view to protecting infants from harm in Korea. 
In additio n, we would like to ask for the EU's understanding that Korea has one of the lowest birth 
rates in the world, and thus makes every effort possible to ensure the safety of infants. We also note 
that Article 2.2 of the TBT Agreement does not apply to the leg itimate objective of protecting human 
health or safety.  
2.418.   Regarding the EU's concerns about a substantial increase in testing and certification costs 
for European manufacturers in 2018 due to the amended requirements for Textile Products for 
Infants, we foun d that during the relevant period specific EU manufacturers were faced with an 
increase in testing costs on a single occasion only, which was in line with enforced supervision and 
controls by the Korea Customs Service. Furthermore, the role of the Korea Cu stoms Service is 
prescribed by the Customs Act. Regarding the claims from specific EU manufacturers that their sales -
volume in the Korean market (only a 12% increase in sales) is insufficient compared to their 
increased expenditure for testing (284%), we h ave not found any basis for this claim nor any direct 
connection between testing costs and sales volume during the relevant short period. The EU also 
claimed that testing has not been carried out on an equal basis between domestic and foreign 
producers for  infant clothing. However, the relevant act, the "Special Act on the Safety of Children's 
Products", unequivocally ensures equal treatment between domestic and foreign manufactures with 
respect to national treatment in the context of goods and manufacturer s. We also note that on no 
other occasion have any other countries made a similar complaint in this respect. Korea very much 
hopes to resolve the EU's concerns at this TBT Committee in a mutually beneficial manner.  
2.1.3.55   Mexico - Various State Measures Restricti ng Sale of Food and Drink Products to 
Minors (ID 64892) 
2.419.   The representative of the United States  provided the following statement. The United States 
continues to be concerned about Mexico's prohibition of sales of "high-calorie " foods and beverages 
to minors, including already passed state -level bans in Oaxaca and Tabasco, a proposed federal ban, 
and additional state -level bans under consideration. We request that Mexico notify Oaxaca and 
Tabasco's state -level measures to the WTO  and postpone finalization and implementation until 
Members have an opportunity to review and comment.  We requested notification on 18 August 2020, 
through the US WTO TBT Enquiry Point, and at the October 2020 TBT Committee meeting. In the 
United States' v iew, these measures form part of a larger national approach to nutrition and public 
health, in conjunction with federal -level technical regulations, and therefore should be notified to 
the WTO. Furthermore, any measures that have a significant effect on tr ade may be raised in the 
TBT Committee, irrespective of the measure being introduced at the federal - or state -level. In 
particular, these measures classify foods as "high-calorie " based on nutrient thresholds established 
in a corresponding federal technica l regulation, Official Mexican Standard NOM -051 SCFI/SSA1 -2010 
"Labeling for prepackaged food and non -alcoholic beverages – Commercial and Health Information. " 
While the United States continues to support initiatives that advance the goal of promoting heal thy 
dietary choices and lifestyles to children, our understanding is that the measures will impact a large 
number of products. We urge Mexico to ensure that its measures are no more trade restrictive than 
necessary to achieve its legitimate objectives. We ask that Mexico please provide an update on the 
current status of this issue, and, again, to please notify these measures to the TBT Committee.  
2.420.   The representative of Colombia  provided the following statement. Colombia shares this trade 
concern and indicate s its interest in the matter, given it is closely related to other items reviewed 
on the Committee's agenda. As noted by other Members, we consider that these measures that are 
being taken at the subnational level must be notified to the C ommittee and be in line with the 
 
92 For previous statements follow the thread under ID 648. G/TBT/M/83  
 
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  provisions of the WTO TBT Agreement.  We urge Mexico to take account of the relevant international 
standards and adopt the least trade -restrictive measures to fulfil legitimate public policy objectives  
2.421.   In response, the representative of Mexico provided the following statement. As mentioned 
in the statement made during the Committee meeting in October 202093, these state measures are 
part of a national strategy aimed at combatting public health problems in the country such as obesity 
and overw eight, in both adults and minors.  The Government of Mexico has analysed these legislative 
amendments and, on the basis of this analysis, we reiterate that the amendments do not fulfil the 
assumptions that would make them verifiable as a technical regulatio n in the light of the definition 
contained in the WTO Agreement on Technical Barriers to Trade and , therefore, no notification  of 
these amendments  to this Committee is foreseen . I wish to reiterate that the relationship between 
these state measures and Mex ican Official Standard NOM -051 concerns only the scope of application, 
and that state measures do not elaborate on additional conditions and do not contain any TBT 
requirements. To date, besides  Oaxaca and Tabasco, no amendments have been approved in other  
Mexican states.  
2.1.3.56   India - Phase II of the Mandatory Testing and Certification of 
Telecommunications Equipment (MTCTE), implementing the Indian Telegraph 
Amendment , G/TBT/N/IND/66 , G/TBT/N/IND/158 , G/TBT/N/IND/159 , 
G/TBT/N/IND/160 , G/TBT/N/IND/161 , G/TBT/N/IND/162 , G/TBT/N/IND/163 , 
G/TBT/N/IND/164 , G/TBT/N/IND/165 , G/TBT/N/IND/166  (ID 64694) 
2.422.   The representative of the United States  provided the following statement. The United States 
understands that a 24 June 2020 ad dendum to India's Mandatory Testing and Certification of 
Telecom Equipment (MTCTE) procedures extended recognition of test results from laboratories 
accredited by International Laboratory Accreditation Cooperation (ILAC) signatories to 30 September 
2020. A ccording to US industry, India further extended recognition of technical parameter test 
results from ILAC -accredited laboratories until June 2021. However, US industry reports that this 
extended recognition does not apply to electromagnetic interference an d electromagnetic capability 
(EMI/EMC) test results from ILAC -accredited laboratories. The United States requests that India 
recognize all relevant test results, including EMI/EMC results, from ILAC -accredited laboratories, for 
at least one year from the d ate of publication of any future phases of this measure. This extended 
period of recognition will help alleviate concerns regarding potential testing backlogs and will allow 
time for manufacturers to perform in ‐country testing for noncertified products, in cluding new models. 
The United States appreciates India's floor response during the October 2020 TBT Committee 
meeting, which noted that to maintain business continuity and ensure existing business supply 
chains remain undisturbed, India would provide a si x-month exemption for the labelling requirement 
for MTCTE -certified products from the date on which testing and certification become mandatory for 
such products. However, considering the scope of test requirements under the MTCTE, the technical 
complexity involved, as well as disruptions to product testing and certification timelines caused by 
the COVID -19 pandemic, the United States respectfully requests that India provide a one -year 
exemption period, rather than six months, from in -country testing and cer tification requirements 
from the date of publication of any future MTCTE phase notifications.  
2.423.   The representative of Canada  provided the following statement. Canada understands that, 
according to a 13 November 2020, Addendum from the Technical Engineering C entre (TEC), 
acceptance of test results and reports from labs accredited by ILAC signatories in the context of the 
implementation of Phase 2 of the Mandatory Testing and Certification of Telecommunications 
Equipment (MTCTE) has been extended to 30 June 202 1. While Canada welcomes this development, 
Canada continues to be concerned with India's movement away from accepting testing in ILAC -
accredited labs outside India for telecommunications equipment. Accepting foreign test results, in 
appropriately accredite d labs, is the least trade -restrictive manner of achieving legitimate safety and 
security objectives. Canada wishes to further note the high cost that the measure imposes on foreign 
suppliers, which must produce the product for testing, ship it to India an d then wait for the product 
to be tested before being able to put it on the market. Operators need at least a year to undertake 
this process. This is why Canada requests that India provides firms with at least one year to comply 
with any future phases of t he measure. We understand that Phase III of the MTCTE could be 
 
93 G/TBT/M/82 , paras. 2.56 -2.57. 
94 For pr evious statements follow the thread under ID 646. G/TBT/M/83  
 
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  implemented by the end of 2021; can India provide any information on Phase III, including potential 
timelines for implementation?  
2.424.   In response, the representative of India provided the following  statement. Mandatory Testing 
and Certification of Telecom Products (MTCTE) scheme provides for acceptance of test results from 
TEC designated Conformance Assessment Bodies (CABs) or test labs from MRA partner countries. 
Acceptance of test results from lab oratories accredited by International Laboratory Accreditation 
Cooperation (ILAC) signatories is by way of relaxation until sufficient test capability exists in the 
country. Testing capability for the requirements outlined in the Indian Telegraph (Amendmen t) 
Rules, 2017 is reviewed from time to time. As adequate in -country testing capability exists for 
EMI/EMC and Safety related test parameters, relaxation for acceptance of test results from 
laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories 
ceased from 31 March 2020. For technical parameters, acceptance of test results from laboratories 
accredited by International Laboratory Accreditation Cooperation (ILAC) signatories is available up 
to 30 June 2021. Regarding the need for relaxation for products to be covered under future phases 
of MTCTE, they will be looked into at the time of launch of notification for such products. Moreover, 
the MRA agreement with India shall facilitate OEMs to test in MRA partner country w hich may lessen 
the burden in terms of cost and time. In order to maintain business continuity and to ensure existing 
business supply chains remain undisturbed, the date of enforcement for the products covered under 
future phases of MTCTE is likely to be f rom six to eight months from the date of notification. 
Considering a relaxation for six months for the labelling requirement for MTCTE -certified products 
from the date on which testing and certification become mandatory, the OEMs will get a period of 
more than one year to comply with the labelling requirement of MTCTE for such products. The 
request of Canada to provide firms with at least one year to comply with any future phases of the 
MTCTE shall be considered at the time of launch of future phases of MTC TE. 
2.1.3.57   India - Notification of 2018 draft cosmetic rules, amending provisions of the 
India Drug and Cosmetics Act of 1940, G/TBT/N/IND/101  (ID 58695) 
2.425.   The representative of the United States  provided the following statement. We understand 
that on 15 December 2020, India's Ministry of H ealth and Family Welfare published the Cosmetics 
Rules, 2020 (as final), in the Gazette. While we thank India for notifying a previous draft of the Rules 
to the WTO in June 2019, as the final version has been partially changed or amended, we ask that 
India notify the final Rules as an addendum to its original notification, provide a public comment 
period of at least 60 days, and delay implementation of the final Rules until such comments may be 
taken into account. We understand that India adopted and implem ented the final Rules on the same 
date as the Gazette notification. To allow sufficient time for manufacturers to adapt their products 
or methods of production to the new requirements, we also ask that India provide a 12 -month 
transition period for new pro duct registrations from the date the final Rules are notified to the WTO. 
Will India consider US cosmetics already on the market in the United States as conforming with 
India's requirements? Can India please clarify per Article  39 if imported products must comply with 
the Bureau of Indian Standards (BIS) standards listed in Schedule Nine, or if India will allow other 
means by which imports can establish conformity? While the US FDA does not require animal testing 
and encourages the use of alternative methods, we note that some foreign jurisdictions still require 
animal testing for cosmetics, even when alternatives exist. We therefore ask that India consider 
amending Article 18.4 of the final Rules to exempt cosmetic products and ingredients subject to 
animal testing when such tests were conducted pursuant to the requirements of foreign jurisdictions. 
We ask that in Article 34, India consider adopting the US FDA Cosmetics Labelling Guide on use of 
the term, "may contain, " for label ling of cosmetic products that have colour additives that are not 
found in all shared formulations of that product.96 
2.426.   In response, the representative of India provided the following statement. A draft of 
Cosmetic Rule 2018 had been published by the Governm ent of India in the official Gazette via G.S.R 
1153(E) dated 29 November 2018 for inviting public comments within the period of 45 days from 
the date on which copies of the Gazette of India containing these draft rules are made available to 
the public. On request, additional 60 days were provided for comments before finalization of the 
draft rules. Finally, Cosmetics Rules, 2020 has been published by Ministry of Health and Family 
 
95 For previous statements follow the thread under ID 586 . 
96 More information on the US FDA labelling guide and requirements are available at 
https://www.fda.gov/cosmetics/cosmetics -labeling -regulations/cosmetics -labeling -guide   and 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=701.3   G/TBT/M/83  
 
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  Welfare, Government of India via Gazette notification G.S.R 763(E) dated 15 De cember 2020, and 
which come into force on 15 December 2020. In response to the question "Will India consider US 
cosmetics already on the market in the United States as conforming with India's requirements? " Yes, 
if cosmetics products comply with provisions  of Cosmetics Rules, 2020 (with respect to products 
already in the market). These rules have not put any embargo on the cosmetics products to be 
imported from the US or any other country.  
2.427.   As per Rule 39 of Cosmetic Rule 2020, no cosmetic shall be imported or manufactured unless 
it complies with the specifications prescribed under the Ninth Schedule or any other standards of 
quality and safety, applicable to it, and other provisions under the rules. In case the cosmetic is not 
included under the Ninth Schedu le, it shall meet the requirements under these rules and 
specifications and standards applicable to it in the country of origin. As per rule 135 -B, Drugs and 
Cosmetics Rules 1945, no cosmetic that has been tested on animals after the 12th day of November 
2014 shall be imported into the country. The same provision has been retained (Rule 18(4)) under 
Cosmetics Rules 2020. As per Rule. 39 (3) of Cosmetics Rules 2020, no cosmetic shall be imported 
or manufactured which contains dyes, colours and pigments other  than the one specified by the 
Bureau of Indian Standards (IS: 4707 Part I or IS: 4707 Part 2 as amended) and included in the 
Tenth Schedule. Further, as per Rule 34 (7), Manner of labelling, in all cases, the list of ingredients, 
present in concentration of more than 1%, shall be listed in the descending order of weight or volume 
at the time they are added, followed by those in concentration or less than or equal to 1%, in any 
order, and preceded by the words 'INGREDIENTS'. It is provided that this stateme nt need not appear 
for packs of less than or equal to 60 ml of liquid and 30 gm of solid and semi -solids.  
2.1.3.58   Brazil - Draft Technical Resolution nº 69, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Composition, in Portuguese, in the L abel of 
Personal Hygiene Products, Cosmetics and Perfumes, G/TBT/N/BRA/608 , 
G/TBT/N/BRA/608/Add.1  (ID 44397) 
2.428.   The representative of Mexico  provided the following statement. The delegation of Mexico 
thanks Brazil for the bilateral meeting and looks forward to continu ing discussions on this subject. 
Mexico  refers to Resolution RDC No. 432 of the Brazilian National Health Surveillance Agency 
(ANVISA),  notified as a final measure by the Brazilian Ministr y of Health to the Members of this 
Committee on 26 November 2020 in document  G/TBT/N/BRA/608/Add.1 . Article 2 of the Resolution 
states that "the personal hygiene products, cosmetics and perfumes marketed in Brazil must have 
their chemical composition written in Portugue se on their labels, without prejudice to the other 
requirements established in the regulations in force". Furthermore, Article 2.1 of the Resolution 
states that the requirement to include the International Nomenclature of Cosmetic Ingredients 
(INCI) remain s mandatory for the labelling of the products mentioned above.  These are two 
requirements that focus on the same objective, which is, to provide  information on the composition 
of the product.  Given the requirement contained in the Resolution for the inclus ion of the chemical 
composition in Portuguese, and the mandatory inclusion of the INCI nomenclature, the measure is 
considered more restrictive for international trade than necessary  and contrary to the principle of 
proportionality provided for in Article 2.2 of the WTO TBT Agreement. It also represents two 
procedures for the same purpose, and an additional and more burdensome process for the industry 
exporting these products to Brazil.  In this context, it is important to emphasize that the use of the 
INCI nomenclature is an international practice that has allowed regulatory convergence in this area 
not only between Mexico and Brazil, but also among  industries worldwide, and its creation seeks to 
provide accurate and standardized information about the ingred ients on the labels of cosmetics, 
personal hygiene products and perfumes. It is therefore considered that the application of the INCI 
nomenclature is sufficient to achieve the desired objective.  In light of  the above and recognizing the 
importance of keeping consumers informed, we request the Government of Brazil to re -evaluate this 
requirement in order to prevent these products from creating unnecessary restrictions on trade.  
2.429.   The representative of the Europ ean Union  provided the following statement. The European 
Union would like to thank Brazil for a very constructive and useful bilateral meeting on this subject 
held earlier this week and for the willingness to explore trade -facilitating solutions, including  a 
postponement of the implementation date. Nevertheless, the EU would like to recall that the main 
source of our concern remains the fact that from the international trade perspective, the new 
labelling rules may set a wrong regulatory precedent. The tran slation of scientifically and 
internationally recognized INCI names into national languages will cause unnecessary administrative 
 
97 For previous statements follow the thread under ID 443. G/TBT/M/83  
 
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  and economic burdens to cosmetic manufacturers and ultimately lead to confusion, misidentification, 
or the loss of essential i nformation for consumers. The EU maintains its interest in finding a mutually 
acceptable solution.  
2.430.   The representative of Colombia  provided the following statement. Colombia would like to 
raise its concern  regarding various elements of Brazil's notification  G/TBT/N/BRA/6 08/Add.1 . 
Colombia's comments were sent through the contact point.  The main concern is that ANVISA 
Resolution  - RDC No. 432 of 2020 stipulates that the list of ingredients of personal hygiene products, 
cosmetics and perfumes must be included in Portuguese.  However, at the international level, the 
declaration of ingredients for these products is made through a single universally recognized 
nomenclature known as the INCI (International Nomenclature of Cosmetic Ingredients).  For our 
industry, the mandatory tra nslation into Portuguese of such a globally -recognized nomenclature is 
an additional process and a  one-off requirement, which has never been registered at the 
international level. The situation therefore poses technical, logistical and economic challenges for 
the marketing of products in this sector in Brazil.  Account should be taken of the fact that the use 
of the international nomenclature INCI for the declaration of ingredients has not created any sanitary 
or problematic risk to the protection of human h ealth and safety. It is therefore considered that 
there are no health grounds to justify the measure.  Thus, this measure may be more trade restrictive 
than necessary, whereas the INCI nomenclature is an equal and less burdensome alternative to fulfil  
the legitimate objective identified.  
2.431.   In response, the representative of Brazil  provided the following statement. RDC 432/2020 
establishes that personal hygiene products, cosmetics and perfumes marketed in Brazil must have 
their chemical composition written in P ortuguese in their labels. The regulatory process for the 
issuance of said regulation took place to ensure compliance with a final judicial decision from an 
appellate court in Brazil, against which no appeal can be filed. According to the decision, the Nat ional 
Health Agency (Anvisa) was obliged to edit a regulation that foresees mandatory description of the 
ingredients in Portuguese for the labelling of personal hygiene products, cosmetics and perfumes. 
The judge asserted that the Brazilian Consumer Code r equires that all product information must be 
presented in Portuguese, which was not observed in personal hygiene products, cosmetics and 
perfumes. Thus, the absence of components in Portuguese would be a violation to the Code. It is 
worth noting that such judicial process has been evolving since 2014 when a trial court first decided 
on the merit of the regulation notified as G/TBT/N/BRA/608 . Since then, as a party to the process, 
Anvisa presented technical elements stressing that it is not necessary to include the description of 
the ingredients in Portuguese. As a member of the International Cooperation on Cosmetics 
Regulation (ICCR), it presented technical grounds to support a harmonized nomenclature that 
provides greater transparency to customers, producers, and health professional s. Anvisa is aware 
that INCI is a nomenclature specially conceived for the substances and ingredients used in the 
production of cosmetic products, through a system based on scientific names and other Latin or 
English words, depending on their origin. It re presents a code that covers the need to designate, in 
a clear, unique, and unequivocal way the labelling of cosmetic ingredients without distinguishing 
between language or characters. Despite its efforts, Anvisa can no longer reverse the decision that 
motivated RDC 432. However, the agency is evaluating the possibility of delaying its entry into force 
to 5 November 2023. Anvisa is also studying alternatives such as the use of QR codes to describe 
the composition in Portuguese, in order to minimize the costs  of implementing the new labelling 
requirements.  
2.1.3.59   India - Mandatory Certification for Steel Products , G/TBT/N/ IND/32 , 
G/TBT/N/IND/32/Add.1 , G/TBT/N/IND/32/Add.2  (ID 22498) 
2.432.   The representative of Japan  provided the following statement. Regarding implementing of 
IS for steel products, Japan has requested that India should ensure proper implementation through 
discussions in the TBT Committee from 2008 -2013. However, it is taking a very long time to get 
approval of conformity assessment, and it has become normal that no response is given to Japanese 
steel companies even after a year has passed, especially for new projects. The Government of India 
cannot proceed in application and scheduling factory audits b ecause of COVID -19, therefore Japan 
has requested the Ministry of Steel and BIS to implement appropriate alternative measures and 
postpone the enforcement of new standards. If nothing is done, it may become a substantial import 
restriction measure, so we w ould like to request the implementation of appropriate alternative 
measures and the postponement of the introduction of new compulsory standards. In addition, the 
 
98 For previous statements follow the thread under ID 224. G/TBT/M/83  
 
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  Government of India requested that Japanese companies submit future plans for indigenous 
development or to switch to local procurement from Indian companies which is not related to the 
application of conformity assessment. These requirements are not required to be submitted in the 
original procedure. Japan would like to request strongly for immedi ate improvement in these issues. 
Finally, Japan would like to request that the implementation of these mandatory standards should 
be done consistently with the TBT Agreement and that it would be no more trade -restrictive than 
necessary to achieve its legit imate objectives.  
2.433.   In response, the representative of India provided the following statement. Mandatory BIS 
Certification for Steel Products is enforced through notification of QCOs to ensure that the quality of 
steel being manufactured by domestic producer s or imported in the country is as per the Indian 
Standards. It may be noted that WTO recognizes the Member's right to implement measures to 
achieve legitimate policy objectives, such as the protection of human health and safety, or protection 
of the envir onment. The Technical Regulations/QCOs on steel and steel products have also been 
issued based on the same policy objectives such as protection of human, animal or plant health, 
safety of the environment, or prevention of unfair trade practices, or nationa l security. QCOs notified 
by Government are not trade -restrictive but a necessity to fulfil a legitimate objective of ensuring a 
level playing field for the domestic as well as the foreign suppliers and also save the Indian 
consumers and common citizens fr om the dumping of spurious and defected steel and steel products. 
India is a developing economy and steel is one of the critical elements enumerated in the 
development of infrastructure in the country. Ensuring the quality of steel and steel products used 
in the housing and infrastructure and other critical end -use sectors of the economy , through the 
implementation of Technical Regulations, is a necessity for the country. Technical Regulations on 
the Indian Steel provide an impetus towards the "Zero Effect and Zero Defect" objective  of the Indian 
Government and also lead to a quality steel products regime. India has adopted the method of 
implementation of Technical Regulations based on the Indian Standards. The Indian Standards are 
well documented and aligne d to the world standards. All the TRs issued by the Ministry of Steel along 
with the details of adoption or application of technical regulations are WTO compliant and had been 
submitted through the WTO Secretariat and uploaded on the WTO website for the ex amination, 
analysis and comments of all the WTO Members.  
2.1.3.60   European Union - Chlorothalonil (pesticide active substance), 
G/TBT/N/EU/625 , G/SPS/N/EU/394 , G/SPS/N/EU/394/Add.1  (ID 57999) 
2.434.   The representative of Costa Rica  provided the following statement. Costa Rica fully supports 
the comments made by Colombia and reiterates its con cern 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 chlorothalonil.  Costa Rica' s concern has been raised during previous meetings of 
this Committee and is based on  the lack of conclus ive scientific evidence and the application of a 
precautionary approach in the processes to renew the marketing approvals , which then affect the 
establishment of MRLs. This has happened in  the case of chlorothalonil, with the Regulation relating 
to this su bstance entering into effect in May 2020 despite the many concerns raised in various WTO 
bodies at both the bilateral and regional level, and 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 WTO 
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 and 2021, including the non -renewal of the active substance 
chlorothalonil.  
2.435.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regard ing 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 ingredient chlorothalonil.  Despite the many 
technical and scientific comments submitted within the consultation deadlines, and requests for a 
longer transition period to adapt production processes, which in the agricultural sector are 
particularly complex, the regulation under which  the marketing approval of the active ingredient 
chlorothalonil is not renewed entered into force in May.  In addition, through European Commission 
Regulation (EU) 2019/677 of 9  February  2021, it was decided to set the MRL at 0.01 mg/kg, or the 
minimum leve l of detection, wh ich will enter into force on 2  September  2021.  These decisions have 
been taken without the EU taking into account the concerns raised by various members in this 
 
99 For previous statements follow the thread under ID 579. G/TBT/M/83  
 
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  Organization and in other settings, and without responding to the calls for d ialogue made on a 
number of  occasions.  As we have already stated, beyond this particular case, the EU has been taking 
measures under which approval for the use or marketing of plant protection products is not renewed. 
Subsequently added to these measures w as the reduction of the MRLs to the minimum detection 
level, further hindering sales of certain agricultural products. An example is the case  we are dealing 
with in this specific trade concern with the substance chlorothalonil.  
2.436.   These measures are being  taken without any sound scientific evidence or proof that they 
effectively constitute less trade -restrictive measures to ensure an appropriate level of protection for 
consumers.  It is important to note that, regarding the review of substances, EFSA has publi shed, as 
it has done more and more frequently, reasoned opinions stating that, owing to insufficient 
information, the risk assessment for active ingredients is inconclusive. In our view, the European 
Commission (DG SANTE) is interpreting these opinions tak ing a precautionary approach rather than 
an approach based on real risk and, as a result, is not renew ing 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 demon strate any effort to obtain the further information necessary to conduct 
a more objective risk assessment.  The foregoing constitutes a violation of Article 2.2 of the TBT 
Agreement, which stipulates that technical regulations shall not be more trade -restrictive than 
necessary to fulfil a legitimate objective. As indicated, there is insufficient information to establish 
criteria for acceptance or rejection of the chlorothalonil compound, given that, from a scientific point 
of view, its effect on health has n ot been clearly determined.   
2.437.   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 insufficie nt scientific evidence to identify the various toxicological aspects 
that may affect 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 t he 
biodiverse agriculture of tropical countries such as Colombia.  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 maintai ning the quality and safety of products during storage, 
transport and distribution, before they reach consumers in the European market. Chlorothalonil is 
used in particular for banana crops, to control Black Sigatoka, a fungus that can devastate this crop.  
Moreover, the situation arising from the COVID -19 global health emergency has forced the health 
and scientific authorities of all countries, and the productive sector, to focus attention on that crisis. 
In line with the statement made in communication G/TBT/GEN/296/Rev.3 , 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 
ingredient chlorothalonil.  
2.438.   The rep resentative 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 analysi s and with no compliance 
with long -standing scientific principles. The non -renewal of approval for chlorothalonil  by the EU did 
not duly consider that it is currently authorized in more than 100 countries, and that the MRLs 
allowed by Codex could reach up to 70 mg/kg. We stress our systemic concern with the fact that 
some hazard -based analyses conducted by the European Food Safety Agency (EFSA) led to the non -
renewal of approvals of some substances and subsequently to the reduction of their MRLs. The 
Brazil ian National Health Agency has set MRLs for chlorothalonil applied to more than 30 crops. The 
case of chlorothalonil is particularly harmful towards Brazil's producers of banana, coffee, citrus 
fruits, papaya, watermelon, among others.  
2.439.   The representative o f Guatemala  provided the following statement. Guatemala wishes to 
express its support for the concern , particularly because there is no information on the scientific 
evidence of the damage to human health arising from the consumption of fruits and vegetabl es, in 
particular those produced in Latin America, and for this reason, it is important to conduct 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 G/TBT/M/83  
 
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  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 d iseases of fungal origin.  
2.440.   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 gr owth of fungi, 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 European 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.  Guatema la's banana 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,  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).  We would therefore be grateful if the European Union would consider the particular 
circumstance s 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 maxim um 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 chlorothalo nil 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 Guatemal a or third 
countries are harmful to the health of European consumers.  
2.441.   The representative of Paraguay  provided the following statement. Paraguay refers to its 
previous statements. Like other Members, we are concerned by the EU's decision to base measures 
on a hazard -based approach without a proper risk analysis and without complying with scientific 
principles. This has resulted in the reduction of MRLs and the non -renewal of substances such as 
mancozeb, chlorothalonil  and picoxystrobin , which will cause sign ificant damage to Paraguay's 
export  sector . As we have previously stated , 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 s cientific 
evidence . We urge the EU  to consider less trade -restrictive alternatives and base its measures on 
conclusive scientific evidence . 
2.442.   The representative of Ecuador  provided the following statement. Ecuador wishes to reiterate 
its concern in relation to notification G/TBT/N/EU/6 25 on the non -renewal of the approval of the 
active substance chlorothalonil and document SANTE/10186/2018 Rev 1, through which the EU 
confirms the non -renewal of the approval of the substance.  The full statement will be uploaded to 
eAgenda; howe ver, I would like to touch upon the main issues raised therein . Chlorothalonil is the 
main tool for controlling Black Sigatoka ( Mycosphaerella fijiensis ) in bananas due to its effectiveness, 
low cost and multisite mode of action, meaning that the risk of resistan ce is low. It is available in a 
wide range of products, through many suppliers, and is widely available in the country.  Controlling 
Black Sigatoka is the main challenge for banana production in Latin America. To control the disease, 
strategies of rotating fungicides with different modes of action have been pursued to avoid fungal 
resistance to these compounds. A limited  variety of molecules is available for rotation in spraying 
schedules. Restricting the use of chlorothalonil will further complicate efforts  to prevent pest 
resistance. Our concern stems from the fact that the non -renewal of approval  of chlorot halonil has 
resulted in the notification of document G/SPS/N/EU/394/Add.1 , on 12 February  2021, pursuant to 
which new MRLs came into force for carbon tetrachloride, chl orothalonil, chlorpropham, dimethoate, 
ethoprophos, fenamidone, methiocarb, omethoate, propiconazole and pymetrozine.  In this case, 
tolerance for chlorothalonil in bananas is reduced from 15 ppm to 0,01 ppm. Implementing the MRL 
at default level will affec t banana production in Ecuador. Reducing the MRL for chlorothalonil could 
have a very significant economic impact on small -, medium - and large -scale producers in our 
country, as well as on consumers in the EU, because the supply of our products would be af fected.  
Moreover, no substitute or similar phytosanitary products with the same environmental or 
toxicological profile are currently available, since the alternatives to chlorothalonil (mancozeb, G/TBT/M/83  
 
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  metiram) are already under reviews by the EU.  Ecuador is a major banana -producing country, 
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.  
The productive banan a sector provides jobs 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.   
2.443.   Ecuador is also focused on the implementation and certification of Good Agricultural Practices 
(GAP), having estab lished a public standard for that purpose, which meet the same standards as 
international certifications, such as GLOBAL GAP, since they are based on the following pillars : (i) 
innocuousness : to deliver to the consumer a healthy, nutritious and innocuous p roduct, without the 
risk that it would affect their health; (ii) worker health care : safeguard and care for the health of 
farmworkers on the premises ; (iii) environmental protection : to preserv e and care for  the natural 
resources of the agricultural produc tion unit, beneficial insects, natural barriers within the farm, 
among other things ; and (iv) animal welfare : refers to the animal's condition and how it copes with 
the conditions in which it lives.  Ecuador requests that the European Commission review this  decision, 
as well as the  broader  entry into force of new MRLs, and that it take into account 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  relevant scientific information emanating from 
international specialized agencies recognized by the WTO, such as the Codex Alimentarius, which 
has relevant information on this substance and, in the specific case of ba nanas, has established an 
MRL of  15 pp m. This statement  is underpinned by  the provisions of the WTO SPS Agreement, which 
stipulates  that, when determining the appropriate level of sanitary or phytosanitary protection, 
Members should minimiz e negative trade effects and that sanitary and phytosa nitary measures 
should be scientifically and technically justified, be based on risk assessment and not constitute 
unjustified barriers to trade .  
2.444.   In response, the representative of the European Union  provided the following statement. As 
explained at previous meetings, the EU proposed not to renew the approval of chlorothalonil through 
Implementing Regulation (EU) No 2019/677100, adopted on 29 April 2019 and previously notified to 
the TBT Committee. Chl orothalonil was evaluated in accordance with Regulation (EC) No 1107/2009 
on the placing of plant protection products on the market.101 The conclusion102 by the European Food 
Safety Authority (EFSA) on this substance was published in January 2018. During the  peer review 
process, the approval criteria in Article 4 of the Regulation were not satisfied with respect 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 Maximum Residue Limits (MRLs) for 
chlorothalonil, which was notified to the WTO/SPS Committee ( G/SPS/N/EU/394 ). In view of the 
concerns identified by EFSA, the EU lowered all MRLs for chlorothalonil at the relevant limits of 
quantification through Regulation (EU) 2021/15 5 of 9 February 2021103. The new values will apply 
to all food products as of 2 September 2021, since the Regulation provides for a transitional period 
of six months for application. On that date, also food products produced beforehand must comply 
with the new MRLs. Import tolerance requests, which need to be supported by substantial new data 
addressing the concerns, remain possible and will be assessed on a case -by-case basis by the 
"rapporteur " member State and the EFSA.  
2.1.3.61   United Kingdom - Wine labelling and  documentation requirements at the end of 
the Brexit transition period (ID 663104) 
2.445.   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 following the 21 -month grace period that the UK has implemented. Our wine 
industry is concerned with the current lack of clarity around the requirements. Australia understands 
that, following the UK's exit from the European Union, the UK has rolled over existing EU wine laws 
 
100 OJ L 114, 30.4.2019, p. 15.  
101 http://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107   
102 EFSA 2018 Conclusion on the peer review of the pesticide risk asses sment of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126 :  https://www.efsa.europa.eu/en/efsajournal/pub/5126   
103 OJ L 46, 10.2.2021, p. 5.  
104 For previous statements follow the thread under ID 663. G/TBT/M/83  
 
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  and regulations and has implemented a 21 -month grace perio d for which we are grateful. However, 
it is still not clear what labelling requirements will apply to agri -food products including wine exported 
through the UK to the EU, for example, Australian bulk wine bottled in, and then re -exported from 
the UK, as we ll as bottled wine exported to the UK, some of which may be transhipped to other 
markets. We are seeking flexibility to allow the listing of importers on the label of wine bottles 
imported into the UK and for  multiple destinations. We believe it is possibl e to include a UK importer 
and importers in other third countries and still meet regulatory objectives. 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 req uirements for imported wine. It isn't clear whether a VI -1 form, or 
its equivalent, is required to import into the UK, and then whether a separate, additional, VI -1 form 
is required 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 re -exported to the UK. Australia recognizes the United 
Kingdom's right to regulate, but 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 requirements 
are no more trade restrictive than necessary to achieve their objectives and look forward to working 
closely wit h the UK on this issue to ensure a mutually satisfactory outcome.  
2.446.   The representative of Uruguay  provided the following statement. Uruguay would like to 
thank the delegation of Australia for once again bringing this item to the attention of the Members 
of the Committee.  My delegation thanks the United Kingdom for the clarifications provided at the 
last meeting in October and the guidelines on the import and export of wine, published by the 
Department for Environment, Food and Rural Affairs (DEFRA) on 31  December 2020105, with respect 
to the conservation and incorporation of European  Union regulations in this area, and the 21 -month 
grace period for labelling.  Considering that the United Kingdom has been the main destination for 
Uruguayan wine exports  to the Eur opean Common Market in recent years, our delegation reiterates 
its interest in being informed of the regulatory requirements and conditions that will apply to the 
importation of wine into the Member's market from 1  October  2022, in particular with respect to 
documentation and labelling, and that such requirements will be the least trade -restrictive possible.  
2.447.   In response, the representative of the United Kingdom  provided the following statement. 
The United Kingdom would like to thank Australia and Uruguay fo r their interest in our wine labelling 
and documentation requirements following the end of the United Kingdom -European Union transition 
period.106 We would also like to thank Australia for the constructive engagement we have had on 
this topic bilaterally. F rom 1 January 2021, the Common Organisation of the Markets in Agricultural 
Products (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2020107 allows for either a 
European Union or a United Kingdom importer's details to be shown on the label of wine p roducts 
marketed in Great Britain until 1 October 2022. After that date, only wine products bearing a United 
Kingdom importer's details will be able to be marketed in Great Britain. From 1 January 2021 and 
after 1 October 2022, additional details may be in cluded on the label provided they do not appear 
in combination with the words "imported by" or "importer", and that additional details do not confuse 
consumers with regards to the importer responsible for bringing wine into Great Britain.  
2.448.   Under this regula tion, the United Kingdom will continue to accept wine import certificates 
(VI-1) issued by the European Union for wine entering the United Kingdom from non -European Union 
countries.108 Provisions relating to the operation of United Kingdom VI -1 arrangements are contained 
in the retained Regulation 2018/273109 as amended by the Agricultural Products, Food and Drink 
 
105 https://www.gov.uk/guidanc e/importing -and-exporting -wine#contents  (DEFRA, 2020).  
106 As per the United Kingdom's statement of 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 202 0. The following transition period ended on 31 December 2020. At the end of the 
transition period, the European Union (Withdrawal) Act 2018 incorporated the European Union Regulations that 
applied in the United Kingdom at the end of that transition period into our domestic law as retained Regulations. 
This included European Union Regulations relating to wine documentation and labelling. Some minor 
amendments have been, and are being, made to those retained Regulations to make them operable within our 
nation al context.  
107 SI 2020/1453 : https://www.legislation.gov.uk/uksi/2020/1453/contents/made   For further guidance, 
see https://www.gov.uk/guidance/importing -and-exporting -wine  
108 These arrangements are set out in the  Common Organisation of the Markets in Agricultural Products 
and Common Agricultural Policy (Miscellaneous Amendments) (EU Exit) Regulations 2019 (2019  No. 828).  
109 https://eur -lex.europa.eu/legal -content/en/TXT/?uri=CELEX%3A32018R0273   G/TBT/M/83  
 
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  (Amendment etc.) (EU Exit) Regulations 2020.110 Further details of the labe lling and certification 
measures that apply are available on the UK Government website.111 Arrangements relating to 
imports, exports and movement of wine between Australia and Great Britain will be subject to 
simplified procedures as set out in the United K ingdom/Australia Agreement on Trade in Wine. 
Australian wine bottled in the United Kingdom and re -exported to the European Union will continue 
to be subject to European Union rules when imported into the European Union from Great Britain. 
The United Kingdo m takes note that Australia has sought assurances that our processes will not be 
overly burdensome. We will work closely with the industry to develop a streamlined and user -friendly 
system, with a view to ensuring that any labelling and documentation requi rements are no more 
trade restrictive than necessary. The United Kingdom welcomes further bilateral engagement with 
Australia on this matter and invites bilateral engagement with Uruguay.  
2.1.4   Reported progress on STCs  
2.449.   The representative of the United States  reported on the resolution of a specific trade concern 
with regard to Brazil 's Ordinance 259 of 27 May 2019. This measure corrected and updated 
conformity assessment requirements to medical devices and had been originally notified in 
G/TBT/N/BRA/605  and its addend a.112 The United Stat es noted that the measure now aligned 
medical  device conformity assessment requirements with international practices, including by 
removing the requirements to retest medical devices every two or four years and by removing the 
requirements to recertify med ical devices every five years. Also, other requirements, unique to 
Brazil, had been made. These changes had addressed the concerns raised by the United States.  
2.450.   The representative of Brazil  valued the cooperation with the United States and confirmed 
the res olution of the trade concern.  
2.1.5   Trade Concerns Database – Beta version  
2.451.   The Secretariat  reported on an information session introducing the Trade Concerns database 
(beta version) on 24 February, which took place over Zoom. It was noted that the Trade Concerns  
database is a first step in the process of replacing the aging TBT -IMS, which had originally been 
launched in 2009, in line with instructions of the TBT Committee. The database integrates 
information on TBT and SPS specific trade concerns. It aims at impr oving access to the information 
on STCs already available to Members and the public through the TBT - and SPS -IMS. The Trade 
Concerns database is a work in progress, and there may be glitches or missing information. At the 
moment, information contained in t he database is only complete in English. Spanish and French data 
were in the process of being added. The purpose of the information session was to demonstrate the 
database, and Members were encouraged to provide their feedback to the Secretariat.  
2.2  Exchange  of Experiences  
2.2.1   Transparency  
2.452.   The Chair recalled that the Committee had held a thematic session on Transparency on 
4 February 2021. He referred delegations to his report on the session, circulated in JOB/TBT/402  – 
as well as the Secretariat 's note on "Using ePing to Disseminate Comments and Replies on 
Notifications" ( JOB/TBT/396 ). He noted that, regarding other matters, there were no further updates 
regarding statements from Members unde r Article 15.2. He reminded Members that the Annual 
Review ( G/TBT/45 ) contains more details on Members' statements of implementation. In addition, 
the Secretariat had held an ePing information session on 22 February and for any further queries 
regarding ePing, Members were invited to contact the  Secretariat directly.  
 
110 SI 2020/1637,  https://www.legislation.gov.uk/ukdsi/2020/9780348214109/contents   
111 https://www.gov.uk/guidance/importin g-and-exporting -wine  
112 Brazil - Ordinance 259, on 27 May 2019, which makes corrections and updates to the Conformity 
Assessment Requirements for Medical Devices Subject to the Health Surveillance System in Ordinance 54, from 
1 February 2016 ( ID 604 ) G/TBT/M/83  
 
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  2.2.2   Standards  
2.453.   The representative of Canada  presented the moderator 's report of the Committee 's 
8 December 2020 Workshop on the Role of Gender in the Development of Standards. The full report, 
provided by Ambassador De Boer of Canada, is contained in G/TBT/GEN/309 . 
2.2.3   Conformity assessment procedures  
2.454.    The Chair recalled that, since its last meeting, the Committee had received a new s ubmission 
from China, contained in document JOB/TBT/391 . A total of six submissions had now been tabled 
(the others being from: 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 ). It was recalled that 
at the informal meeting of 8 December, the Committee had had a productive exchange of views on 
the development of guidelines on Conformity Assessment – the most recent di scussion had been 
summarized in document JOB/TBT/273/Rev.7 .  
2.455.   The representative of China  introduced his delegation 's proposal. The main purpose of 
China 's proposal ( JOB/TBT/391 ), he stressed, was to su pport the WTO in implementing a quality 
infrastructure system as a fully integrated system. An example of what China had done to implement 
a national quality infrastructure was presented. This system, it was noted , was essential for 
supporting regulators w hen selecting and developing conformity assessment procedures, as well as 
enforcing them. For the guidelines, it was also important to consider risk assessment and the use of 
risk-based decision making (e.g., different procedures for low - and high -risk pro ducts). Market 
supervision was also important – there was a need to shift from pre -market control to post -market 
control. China also stressed the importance of inclusiveness, including the use of international 
standards and respecting the differences acros s Members (laws, practices, policies and regulatory 
objectives) and appropriate flexibilities.113 In conclusion, China stressed his delegation 's willingness 
to engage in discussions on the topic of conformity assessment procedures.  
2.456.   The representative of th e United States  thanked China for the proposal and noted that her 
delegation would be reviewing the paper and the presentation.  
2.457.   The representative of New Zealand  expressed her delegation 's support for ongoing work on 
the development of non -prescriptive gui delines on conformity assessment procedures in the context 
of the 9th Triennial Review. She thanked Members for their efforts and acknowledged the 
contributions on the table. New Zealand wished to make a few remarks for the Committee 's 
consideration. Build ing on what Australia had shared earlier, her delegation believed that the 
guidelines would need to emphasize the principles of transparency and good regulatory practice for 
conformity assessment procedures as significant contributors of the reduction of t rade barriers. They 
needed to be trade facilitating and promote the use o f relevant international guides , 
recommendations  and standards  when adopting regulatory texts for conformity assessment 
procedures, so as to avoid unnecessary duplication . The guideli nes would also need to allow for 
sufficient flexibility for regulators and policy makers to innovate and be able to select the conformity 
assessment procedure most aligned with their particular need and circumstances, and regulatory 
policy objectives. Ther e was considerable value, she said, to promoting dialogue on regulatory 
cooperation and coordination with a view to deliver ing confidence in regulatory convergence  
outcomes .  
2.458.   The representative of Paraguay  stressed the importance of flexibility and the nee d to take 
into account the realities of different countries as the development of conformity assessment 
procedures was a major challenge for developing countries. It was important to leave room for 
innovation so that countries could find the right balance,  appropriate and tailored to their own 
circumstances and policy objectives.  
2.459.   The Chair encouraged Members to come forward with additional submissions to help the 
Committee advance its work. He also noted that one of the proposals on the table for the 9th Triennial 
Review was also on the topic of conformity assessment procedures. The Chair stressed that anything 
that was achieved in the work flowing from the 8th Triennial Review, could be rolled into the 9th 
 
113 The full presentation of the proposal is contained in JOB/TBT/403  and JOB/TBT/403/Corr.1  
 G/TBT/M/83  
 
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  Triennial Review. He stressed that continued engag ement was important to enable the Committee 
to advance on this mandate.   
2.3  Report on Informal Meeting of 8 December  on Conformity Assessment Procedures, 
COVID -19 Information Sharing and Workshop on the Role of Gender in the Development 
Of Standards  
2.460.   The Chairman reported on the informal meeting of the TBT Committee, held on 8 December 
2020 to discuss conformity assessment procedures (CAP) and COVID -19 information sharing. The 
full report is contained in JOB/TBT/395 , dated 22 January 2021. This report also contains a reference 
to the r eport on the workshop on the Role of Gender in the Development of Standards (mentioned 
above and contain in separately in G/TBT/GEN/309 ). 
3  NINTH TRIENNIAL REVIEW  
3.1.  The Chair  introduced his report on the Committee 's informal meeting held on 23 February 2021 
on the 9th Triennial Review. An advance copy was provided in the room at the time of the meeting. 
Subsequently, the final version was circulated in JOB/TBT/404 , on 9 March 2021.   
4  TWENTY -SIXTH ANNUAL REVIEW  
4.1.  The Secretariat  introduced the Twenty -Sixth Annual Review of the Implementation and 
Operation of the TBT Agreement u nder Article 15.3 , contained in G/TBT/45 . The Committee took 
note of this report.   
5  TECHNICAL COOPERATION ACTIVITIES  
5.1.  The representative of the United States  highlighted its ongoing efforts to support the 
implementation of the TBT Agreement. She spoke of a public -private programme between the US 
Agency for International Development (USAID) and the American National Standards Institute 
(ANSI), which coordinated  aid in developing countries, and LDCs, to prioritize needs for technical 
assistance. The Standards Alliance had been established in 2012 with a focus on implementation of 
the TBT Agreement in 10 countries; it was later expanded. The original Standards All iance would 
come to a close in 2021 but the programme had been renewed for a second phase in 2019. Based 
on lessons learned in the first phase, targeted technical assistance would be provided to developing 
countries, including the support of development of  national quality infrastructure, and good 
regulatory practices that are rooted in the principles of the TBT Agreement. To date, the Standards 
Alliance had completed over 100 trainings and workshops with more than 4,500 participants. It had 
helped increase  capacity in partner countries in several specific areas. More detailed is contained in 
the full report available in G/TBT/GEN/311 . 
5.2.  The Secretariat  introduced the Third Edition of the WTO Agreements Series Technical Barriers 
to Trade Handbook, available on the WTO Website.114 
6  OBSERVERS  
6.1  Updates  
6.1.  The representative of the  OECD  shared information with the Committee on the "Global 
Partnership to Implement the GHS" (Globally Harmonized System for the Classification and Labelling 
of Chemicals).  The full presentation is contained in document G/TBT/GEN/ 313. The Chair drew the 
Committee 's attention to information provided by other observers ( BIPM, IEC and ISO 
(G/TBT/GEN/314 )). 
6.2  Pending Requests  
6.2.  Regarding pending requests for ob server status, the Chair recalled that the list of observers, 
including pending requests, is contained in document G/TBT/GEN/2/Rev.15  circulated on 
22 February  2021. He drew delegations' attention to a recent request for observer status received 
 
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  from the Arab Industrial Devel opment, Standardization and Mining Organization (AIDSMO). In 
addition, he said, document RD/TBT/1/Rev.7  provide s a compilation of the original communications 
received by the WTO from the various bodies that have sought observer status in the TBT Committee 
and whose requests are still  pending. Both these documents were currently up to date (no further 
requests have been received to date). Regarding previous requests, the Chair said that he had no 
new information that would lead him to believe that the situation ha d changed from where t he 
Committee stood at the last meeting. He therefore suggest ed that the Committee  revert to this 
matter when Members had had the time to further consult among themselves.  
6.3.  The representative of Turkey  expressed her delegation 's support for the request from the 
Standards and Metrology Institute for Islamic Countries (SMIIC) . She noted that the process for 
evaluating the applications observer status requests needed to be reviewed in light of the growing 
list of pending requests, some of them dating back severa l years.  
6.4.  The representative of the United States  reiterated that her delegation could not accept SMIIC 
as an observer in the TBT Committee. The BIPM was the relevant inter -governmental organization 
that had been granted observer status; this organization cooperated with Members on the topic of 
measureme nt science, and measurement standards. Moreover, OILM had been granted observer 
status as an inter -governmental treaty organization for legal metrology. These two organizations 
represented the globally recognized framework for metrology that underpinned qu ality 
infrastructure. Also, there were international  organizations with pending requests that needed to be 
given priority before regional bodies were considered, such as ILAC and IAF.  
6.5.  The Chair  encouraged Members to consult on this matter to reach a more s atisfactory outcome. 
He reiterated his willingness, as Chair, to facilitate consultations.  
7  ELECTION OF CHAIRPERSON   
7.1.  The Chair  noted that, at the time of the meeting, Members ha d not yet finalized the selection 
process for the Chairpersons of the Committee on Trade in Goods and its subsidiary bodies, including 
the TBT Committee. This mean t that the current  agenda item would be  suspended,  and that the 
Committee would revert to it at the next formal Committee meeting, when a new Chair may be 
nominated and agre ed for this seat .  
8  DATE OF NEXT MEETING  
8.1.  The Chair recalled that the next  regular meeting of the Committee is scheduled to take place 
on 2-4 June 2021 and will be preceded with an informal meeting on the Triennial Review on 1 June.   
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