RESTRICTED  
  
G/TBT/M/84  
 
 
24 August 2021  
(21-6377) Page: 1/128 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 2-4 JUNE AND 9 JUNE  2021 
CHAIR: MR LAURENCE SANDRAL  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ ........................  1 
2   ELECTION OF CHAIRPERSON  ................................ ................................ .......................  1 
3   NINTH TRIENNIAL  REVIEW  ................................ ................................ .........................  1 
4   IMPL EMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................ . 2 
4.1   Specific Trade Concerns  ................................ ................................ ...............................  2 
4.2   Exchange of Experiences  ................................ ................................ ...........................  124 
5   TECHNICAL COOPERATION ACTIVITIES  ................................ ................................ .. 127  
6   OBSERVERS  ................................ ................................ ................................ .............  127  
6.1   Updates  ................................ ................................ ................................ ..................  127 
6.2   Pending Requests  ................................ ................................ ................................ ..... 127 
7   DATE O F NEXT MEETING ................................ ................................ ..........................  128  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 20. 
2  ELECTION OF CH AIRPERSON  
2.1.  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 agreed for this seat .  
3  NINTH TRIENNIAL  REVIEW  
3.1.  The Chair 's report on the 1 June 2021 informal meeting on the 9th Triennial Review  is contained 
in document JOB/TBT/404/Rev.3 , circulated on 23 July 2021.  
 
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/84  
 
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  4  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
4.1  Specific Trade Concerns  
4.1.1   Withdrawn concerns  
4.1.  The Chair  reported that the following STCs had been withdrawn from  the agenda at the request 
of the concerned Member:  
• Republic of Korea - Amendments to the Act on the Promotion of Saving and Recycling 
of Resources  
• European Union - Directive 2008/98/EC of the European Parliament and of the Council 
on waste  
• Japan - 100% in spection system for sports goods and toys and non -acceptance of test 
reports from Indian test houses  
• China - CSAR - Draft Specifications for Cosmetic Registration and Filings; Draft 
Specifications for Registration and Filing of New Cosmetics Ingredients; D raft 
Specifications for Cosmetic Efficacy Claim Evaluation, Provisions for the Supervision 
and Administration of Toothpaste (ID 665)  
• India - Testing and Certification of telegraph (The Indian telegraph (Amendment) 
Rules, 2017) (ID 558)  
4.1.2   New Specific Trade C oncerns  
4.1.2.1   European Union - Draft EU Batteries Regulation (implementation of the European 
Green Deal), G/TBT/N/EU/775  (ID 6852) 
4.2.  The representative of the Russian Federation  provided the following statement. The Russian 
Federation acknowledges the right of all WTO Members to regulate to achieve legitimate 
environmental objectives. However, we would like to raise concern on the draft EU Regulation on 
batteries and waste batter ies that is developed in order to implement the European Green Deal. The 
draft Regulation was notified in document G/TBT/N/EU/775 . It sets out product requirements for 
new batteries as a condition for access to the EU market as well as material recovery targets for 
waste batteries. F or new batteries the draft Regulation specifically sets requirements on the 
maximum level of carbon footprint over the life cycle of batteries and minimum level of recycled 
materials such as cobalt, lithium and nickel. Apparently, the requirements for the minimum level of 
recycled materials in batteries are aimed to reduce use of primary metals in the EU for the purpose 
of battery manufacturing. It is no secret that the EU does not have sufficient capacities of primary 
non-ferrous metals in its territory in  order to meet internal demand. By introducing provision that 
discriminates imported primary materials vis -à-vis domestically remanufactured, the draft 
Regulation is aiming to substitute imported primary metals for the like domestically recycled ones. 
This is a protectionist aim which we reject as a legitimate one.  
4.3.  Article 2.2 of the Agreement on TBT requires Member to ensure that technical regulations are 
not developed, adopted and implemented in a manner more trade restrictive than necessary to fulfill 
legitimate objectives. The article also requires that technical regulations do not create unnecessary 
obstacles to international trade. In this regard, we are wondering if the European Union considered 
less trade -restrictive measures to stimulate recycling o f nickel, lithium, cobalt, and lead rather than 
such administrative measure as minimum level of recycled materials in the battery. If yes, please 
name the measures that the EU has considered and reasons why these measures have not been 
employed or proposed  for implementation. The current draft Regulation provisions  on recycling 
efficiencies and the minimum requirement of recycled materials targets five metals – cobalt, copper, 
lead, lithium and nickel. We are wondering what criteria have been used by the Eu ropean 
Commission to choose these particular five metals.  
 
2 For previous statements follow the thread under ID 685 . G/TBT/M/84  
 
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  4.4.  As far as the requirement on the maximum level of carbon footprint over the life cycle of 
batteries is concerned, there is no comprehensive methodology to calculate this parameter. 
Moreover, the dra ft Regulation does not specify the ways for the stakeholders from outside the EU 
to submit their data and calculations made under internationally recognized protocols, which are 
likely to be different from the EU standards. As a result, the lack of methodo logical clarity as well as 
the unresolved recognition issue unfairly penalizes non -EU battery value chain economic operators 
and constitutes a technical barrier to trade. Finally, the current approach of the EU concerning the 
recycling efficiencies and rec ycled content target -setting may result in market distortions and supply 
risks and consequently affect the global battery value chains. The EU proposes certain ad hoc due 
diligence requirements that are limited to a number of raw materials only. The introd uction of new 
specific due diligence requirements additional to the existing ones would significantly increase the 
number of audits and reporting requirements for the upstream parts of the supply chains, as well as 
divert resources from proper and efficien t risk management.  
4.5.  The representative of China  provided the following statement. We suggest that the EU 
consider s the following comments and provide s necessary basis or scientific explanation. (i) In 
accordance  with Article 7 and Annex II, the carbon footp rint of rechargeable industrial batteries and 
electric vehicle batteries with internal storage and capacity above 2 kWh is required. However, there 
is no unified international calculation criteria or basis for the carbon footprint of such products, and 
the equitable and scientific assessment is hard to carry out. Besides, as industrial batteries are 
widely used, and of various types, it is difficult to make a unified footprint calculation. Therefore, 
China thinks it is not the right time to carry out those works. ( ii) Regarding the recycled content in 
active materials from batteries in Article 8, it is suggested to cancel the "Minimum share of recycled 
content " in current stage, and to be considered after methodology of the calculation and verification 
is set up. For industrial batteries, electric vehicle batteries and automobile batteries, the regulations 
set the minimum share of cobalt, lead, lithium, or nickel recycled from waste present in active 
materials by 2030 and 2035, but the methodology for the cal culation and verification of the recycled 
materials will not be set out until the end of 2025. In addition, companies in China also considered 
that the recycled proportion of cobalt is relatively high.  
4.6.  (iii) Regarding Article 13 and Annex VI on "Labelling of batteries", according to section 38.3 of 
the UN Manual of Tests and Criteria (UN Transportation Testing), lithium batteries need to be 
marked/labelled with energy (Wh) information on the shell, therefore we recommend that the energy 
(Wh) information sha ll be added to the information on the label of batteries; considering  
environmental protection, we recommend that the CE label and the symbol for separate collection 
of batteries shall be integrated into the QR code; as the appearance of some battery produ cts would 
be black, if the QR code of the product is uniformly required to be 100% black, it may cause the QR 
code to be difficult to read or confused with other information. Therefore, we recommend that the 
requirements of QR code shall change to: clearly  visible, indelible, colour -unified, and easy to 
identify. (iv) It is  suggested that the EU could cancel the disclosure of the technical documents 
containing commercial secrets of enterprises on the premise that regulatory purpose has already 
been met. Art icle 7, article 8 and appendix 2, appendix 13 require to provide the technical 
information, but the technical information about the battery content, the material and processing 
process involves some core secrets, such as the content of cobalt, nickel, lith ium contained in 
batteries, and data about carbon emissions of materials in the process of production, which increases 
the risk of disclosure.  
4.7.  (v) In accordance with Article 15, Article 48, Article 55 and Annex VI, the targets of collection 
rates of waste portable batteries are given, however, the achievement of the target mainly depends 
on consumers' willingness to participate. Therefore, referring to the manufacturers' and importers' 
collection obligations of the WEEE Directive, we recommend to cancel col lection rate, and replace it 
with: manufacturer or importer should establish an effective waste collection management system. 
(vi) In accordance with Article 56, Article 57 Annex XII, the recycling efficiency and material recovery 
targets requirements are given. However, there is currently no sufficient scientific basis to support 
the rationality of these requirements in the world. Also, the requirements of waste materials may 
increase costs of manufacturers and sales enterprises  and cause reliability risks . Therefore, we 
recommend that the limitation requirements shall be cancelled, if not, a scientific and reasonable 
explanation shall be provided, in order to avoid unnecessary trade barriers. (vii) In accordance with 
Chapter VIII and Annex XIII "By 1 Janua ry 2026, the Commission shall set up the electronic 
exchange system for battery information", however, the adaptation period is not specifically 
indicated. In accordance with Article 2.12 of Agreement on Technical Barriers to Trade that "Except 
in those ur gent circumstances referred to in paragraph 10, Members shall allow a reasonable interval G/TBT/M/84  
 
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  between the publication of technical regulations and their entry into force in order to allow time for 
producers in exporting Members, and particularly in developing country Members, to adapt their 
products or methods of production to the requirements of the importing Member", we recommend 
that at least two years adaptation period after setting up of the electronic exchange system shall be 
given.  
4.8.  (viii) In accordance w ith Article 39, Article 72 and Annex X "Obligation for economic operators 
that place rechargeable industrial batteries and electric vehicle batteries with internal storage and a 
capacity above 2 kWh on the market to establish supply chain due diligence pol icies". Considering 
the fact that the raw material procurement due diligence involves a long list of materials, long and 
multiple -layers supply chain , 12 months is not long enough to provide a complete and qualified due 
diligence. Therefore we recommend ex tending the time of provision of the due diligence to at least 
24 months. Besides, China suggests documents concerning unreasonable mining in the origin which 
would cause environmental damage are added, and appropriately to optimize the list of raw 
materia ls based on the results of the actual risk assessment.  
4.9.  The representative of India provided the following statement. India expresses support for this 
STC. 
4.10.   The representative of Canada  provided the following statement. Canada welcomes this 
opportunity to vo ice its interest to work with the European Union throughout the development and 
implementation of this measure to ensure that international trade considerations are fully accounted 
for and provide for an approach that allows for effective and sustainable g lobal battery value chains 
given their key role in advancing our decarbonisation efforts. Recognizing and strongly supporting 
Members' right to regulate, we find common ground with the EU's desire to contribute to sustainable 
development, green mobility, a nd clean energy. On that basis, Canada signals its intention to 
monitor the development of the proposed regulation, and its possible relationship with other 
Members' domestic initiatives on sustainability. Canada looks forward to continuing to engage  and 
collaborate with the EU on its Batteries Regulation as its Implementing and Delegated Acts are 
developed.  
4.11.   In response, the representative of the European Union  provided the following statement. The 
EU would like to thank the d elegations  of China and Russia for their comments on the Proposal for 
a Regulation of the European Parliament and of the Council concerning batteries and waste batteries, 
repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020 (the Batteries 
Regulation). The EU would li ke to recall that the Batteries Regulation proposal was presented on 
10 December 2020 and notified to the TBT Committee on 26 January 2021 with a commenting period 
of 90 days. Batteries are an important source of energy and one of the key enablers for sust ainable 
development, green mobility, clean energy and climate neutrality. In order for the EU's product 
policies to contribute to these objectives, it needs to be ensured that batteries marketed and sold in 
the EU are sourced and manufactured in a sustaina ble manner. Batteries that are more sustainable 
throughout their life cycle are key for the goals of the European Green Deal and contribute to the 
zero pollution ambition set in it. Addressing the entire life cycle of batteries placed on the EU market 
requires the setting up of harmonized product and marketing requirements, including conformity 
assessment procedures. The proposal addresses the social, economic and environmental issues 
related to all types of batteries. Batteries placed on the EU market shou ld become sustainable, high -
performing and safe all along their entire life cycle. This means batteries that are produced with low 
environmental impact, using materials obtained in full respect of human rights as well as social and 
ecological standards. Ba tteries have to be long -lasting and safe, and at the end of their life, they 
should be repurposed, remanufactured or recycled, feeding valuable materials back into the 
economy.  
4.12.   The EU would like to reassure that there will be sufficient time to consider th e feedback on 
the Batteries Regulation proposal. Implementing and delegated acts that will be developed under 
the proposal will involve consultation of stakeholders, though the exact way in which this will be 
done is to be determined in each case separatel y. Their drafts will be notified to the TBT Committee. 
The application dates for some of the provisions in the proposal are relatively soon. This is because 
significant developments in the battery sector are taking place in the near future. However, the EU  
would like to clarify that the indicated application dates are provisional, because it will depend on 
the time needed for the regulatory process to adopt this regulation. The EU currently expects that 
the proposal will be adopted by the Council and the Eu ropean Parliament during 2022. In conclusion, 
the EU stresses that the notified measure seeks to fulfill objectives such as protection of human G/TBT/M/84  
 
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  health and safety and prevention of deceptive practices, which are legitimate policy objectives under 
Article 2. 2 of the TBT Agreement. For the reasons specified above, the EU considers that the notified 
proposal is not more trade -restrictive than necessary to fulfill its legitimate policy objectives, also 
taking account of the risks that non -fulfillment would creat e. It therefore fully complies with the 
provisions of the TBT Agreement.  
4.1.2.2   Egypt - Regulatory Guidelines for the Circulation of Cosmetics Products in Egypt 
(ID 6863) 
4.13.   The representative of the European Union  provided the following statement. The EU would 
like to refer to draft Regulatory Guidelines for the Circulation of Cosmetics Products in Egypt, a non -
notified measure, and to remind Egypt that according to Article 2.9.2 of the TBT Agreement, the 
proposed technical regulations should be notified at an earl y appropriate stage, when amendments 
can still be introduced and comments taken into account. The EU welcomes the Egyptian decision to 
harmonize its cosmetics regulation with global regulatory best practices, and to base it, inter alia , 
on the EU system. However, the non -notified draft Regulatory Guidelines maintain burdensome pre -
market approval and customs clearance processes, while also instituting new, burdensome in -
market enforcement procedures on all products, regardless of risk. As a result, the business 
environment cosmetics producers risk  important disruptions in the Egyptian market. In particular, 
the EU would like to ask Egypt to consider eliminating the pre -approval process (registration), and 
to allow products to go directly  to market once the manufacturer submits adequate product 
information (notification before placing on the market) to enable efficient in -market controls. The 
pre-market approvals are burdensome for the Authority  without safeguarding the consumer as the 
submitted documentation may not reflect actual products on the market, and illegitimate actors may 
bypass the registration process. Furthermore, pre -market approvals add unnecessary costs and 
cause significant delays in placing a product on the market. This i s further exacerbated by the high 
volume of products being registered. As fast -moving consumer goods, cosmetics are dependent on 
seasonal sales and fashion trends; this necessitates the ability to immediately place products on the 
market. Control system ba sed on approvals is an inefficient use of government resources as they 
create bureaucratic burdens for companies that are most likely to comply with regulations and do 
not address counterfeit and/or unsafe products on the market.  
4.14.   In the EU regulatory syste m, consumer safety is ensured by in -market controls based on risk: 
the product information provided must be adequate to demonstrate product safety and for the 
authority to perform in -market control. Given that a burdensome registration process creates 
administrative costs that may result in legitimate products being comparatively more costly to 
illegitimate, counterfeit and unsafe ones, the EU would like to ask Egypt to limit the information 
required to be provided to EDA to what is essentially needed to pe rform in -market control. In 
addition, according to the EU, testing requirements as a condition for pre -market approval are 
unreasonable and should be revised. The EU would also like to ask Egypt to replace the proposed 
customs clearance process with releas e at port and a risk -based approach to inspections for all 
products, not only those that may be sold in designated third countries. The current requirements 
add a significant cost and cause delays, as many shipments must be stored at a bonded warehouse 
for one week at the importer's expense awaiting visual inspection. Such practice increases cost and 
comparatively favours illegitimate products. Furthermore, the delays affect the ability to supply the 
market promptly. The EU would like to note that industry experience globally has shown that customs 
inspections are best performed on a risk -based approach, i.e., in a targeted fashion towards non -
compliant actors and higher risk products.  
4.15.   The EU would also like to ask Egypt to remove the requirement for the not ification number to 
be placed on the packaging. According to the EU, the product name and the address of the person 
responsible for the product safety are sufficient to identify a product and perform in -market control, 
in particular by requesting technical  documentation on the product safety from the responsible 
person. Requiring the notification number to be annotated on the packaging creates additional steps 
in the supply chain. It also results in unnecessary fragmentation of the international supply chai n by 
requiring a unique packaging for Egypt only. International practices give preference to over labelling 
instead of direct annotation of country -specific labelling requirements on the packaging. Finally, the 
European Union would like to ask Egypt to lim it the requirement to report only serious adverse 
events to the authorities. The vast majority of adverse experiences with cosmetic products 
experience relate to minor, temporary skin irritations that are resolved without a need for medical 
 
3 For previous statements follow the thread under ID 686 . G/TBT/M/84  
 
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  treatment. Cosm etics companies perform cosmetovigilance  to understand and improve consumer 
experiences. Reporting all adverse events will result in significant efforts and cost in monitoring for 
both the authorities and industry. The EU would like to suggest a requiremen t to report only serious 
adverse events to allow for more efficient in -market controls and safeguard of public health. The 
European Union calls on Egypt to notify the draft Regulatory Guidelines for the Circulation of 
Cosmetics Products in Egypt in line wi th the provisions of the TBT Agreement, and to give Members 
sufficient time to submit comments.  
4.16.   The representative of the United States  provided the following statement. We understand that 
the Egyptian Drug Authority published a revised draft of its Regula tory Guidelines for the Circulation 
of Cosmetics Products in Egypt. We note that this draft regulation was not notified to the WTO TBT 
Committee and we have made a request Egypt notify the measure on April 26. We welcome an 
update from Egypt on the status of the draft and when it intends to notify the most recent draft to 
the WTO TBT Committee.  
4.17.   In response, the representative of Egypt  provided the following statement. Egypt takes note 
of comments and will revert to the delegations in due course with feedbac k. 
4.1.2.3   Russian Federation - On Safety of Wheeled Vehicles (TR CU 018/2011), 
G/TBT/N/RUS/100  (ID 6874) 
4.18.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the EAEU Council's efforts to protect consumer safety through revision of vehicle regulati ons. 
Furthermore, Korean companies are fully committed to complying with the regulations of EAEU . 
Regarding the EAEU's regulation of "TR CU 018/2011: On Safety of Wheeled Vehicles " notified to 
the WTO on 20 March 2020 as G/TBT/N/RUS/100 , Korea submitted comments in December 2020, 
February 2021, and May 2021, via the EAEU TBT Enquiry Point. Since Korea has not yet received 
any response from the EAEU, we would like to reiterate the comments at this meeting. Firstly, Korea 
requests the EAEU for regulatory improvements for requirements that fall under the e -Call System 
category, stipulated in Clause 16. The requirements are in regard to Mandatory e -Call Installation, 
Error from Standard Time, User Information Support Mode, PSAP Information while Driving, 
Transmission of Surroundings Info rmation, System Operation Signal, and Transmission Protocol, 
respectively. Specifically, Korea asks if each EAEU member State could  regulate the e -Call 
installation requirement under its own domestic law as they see fit because the lack of infrastructure 
in some EAEU member States would hinder the regulation's entry into force. Additionally, apart from 
the current e -Call system meeting the System Operation Signal requirement, Korea asks to clarify 
if the System Operation Signal requirement is mandatory for PSAP (Public Safety Answering Points) 
function as well. If so, Korea requests the EAEU to grant an exemption from its application or a grace 
period of three years before enforcement for vehicles already placed on the EAEU's markets.  
4.19.   Secondly, regarding the  Safety Declaration of Advanced Autonomous Driving Function, Korea 
requests to reflect the UN ECE regulations'  ALKS (Automated Lane Keeping Systems) function on 
Annex 2 of EAEU regulation. And as for other advanced autonomous functions (over SAE level 3), 
Korea requests to recognize certificates if they meet the relevant UN ECE regulations currently under 
revision. Thirdly, regarding the installation of tachometers and additional safety requirements for 
cold/subarctic region, Korea requests to stipulate the  interpretations of the requirements, provided 
by the EAEU representatives at the Korea -EAEU briefing session on 11 September 2020, to promote 
consistency in implementation. Fourthly, regarding the fuel tank and rear side collision, Korea 
requests to consi der revising the requirements to be consistent with the scope of the relevant 
amended international standards (UN R -34.03). Fifthly, since the local manufacturers are having 
difficulties in producing parts that meet the requirements, Korea requests an exem ption (reflecting 
the exception clause in Annex 20) of the regulation on four heavy metal contents (lead, mercury, 
cadmium, hexavalent chromium) in motor vehicle parts. Lastly, regarding the maximum speed 
measurement, the UN ECE R -68 adopted in this regula tion has not been used by countries other 
than Russia due to the need of technical development and financial burden imposed by the addition 
of actual test driving. Therefore, Korea requests the EAEU to retract the requirements. If not, we 
ask for an exempt ion for the vehicles placed on EAEU markets. All details for these six subjects are 
included in our comments submitted to EAEU TBT Enquiry Point on 7 May 2021. We would be grateful 
 
4 For previous statements follow the thread und er ID 687 . G/TBT/M/84  
 
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  if the EAEU would review them again and take into positive consideration an d reply to Korea in 
writing.  
4.20.   In response, the representative of the Russian Federation  provided the following statement. 
We appreciate Korea's interest in the Russian Federation's regulatory policy. The draft amendments 
to the Technical Regulation "On safe ty of wheeled vehicles " that are being discussed in the 
Committee were notified to the WTO on 20 March 2020 in accordance with Article 2.9 of the 
Agreement on Technical Barriers to Trade. 60 -day comment period was provided and expired on 
20 May 2020. Curre ntly, the amendments in question have not been adopted yet. We acknowledge 
receipt of comments by Korea noting that they came with long delay. Russia is open to work on this 
and other issues bilaterally both with Korea and other WTO Members.  
4.1.2.4   Viet Nam - The List of products and goods with unsafe capability under 
management responsibility of Ministry of Information and Communications, 
G/TBT/N/VNM/186  (ID 6885) 
4.21.   The representative of the Republic of Korea  provided the following statement. Korea respects 
and supports the efforts of Viet nam to ensure the safety of its people. Furthermore, Korean 
companies are fully committed to complying with the regulations of Vietnam. However, Korea would 
like to make the following comments reflecting concerns raised by Korean companies regarding the 
amended regulation of "Products and goods with unsafe capability under management responsibility 
of Ministry of Information and Communications, Circular 11/2021/TT -BTTTT. " Korea requests 
Vietnam to consider removing the performance tests requirement from the  amended regulation. 
Under the existing regulation of 'Circular 11/2020/TT -BTTTT,' Appendix II No. 6.1 specifies that 
lithium batteries used for laptops, notebooks, mobile phones, and tablets are only required to meet 
the safety standard tests based on QCV N 101:2016/BTTTT. On the contrary, the amended regulation 
requires companies to submit reports on performance tests as well as safety tests. The amended 
regulation would cause a new burden on most companies in terms of cost and time. Many countries, 
includ ing the EU, China and Japan, require only safety test reports. As an alternative, Korea requests 
Vietnam to provide a transitional period of at least six months after the publication of the final rule. 
If the regulation enters into force on 1 July 2021, as  stipulated in the notification, Korean companies 
exporting goods to Vietnam would encounter difficulties complying with the regulation because more 
than three months will be required to submit performance test reports.  
4.22.   In response, the representative of Viet Nam  provided the following statement. Vietnam would 
like to thank Korea for comments submitted to the Ministry of Information and Communications. 
The draft Circular providing amendments for the Annexes of Circular No.11/2020/TT -BTTTT dated 
14 May 2020 specifying the List of products and goods with unsafe capability under management 
responsibility of Ministry of Information and Communications was notified in G/TBT/N/VNM/186  with 
60 days  provided for comments. After this period, all comments received from WTO Members and 
other stakeholders had been fully taken into considerations. Accordingly, the performance test 
requirement has been removed in the final version of the above -mentioned dr aft Circular, which has 
been promulgated as Circular No. 01/2021/TT -BTTTT on 14 May 2021.  
4.1.2.5   Ecuador - Sanitary Technical Regulation on processed foods, processing plants, 
establishments for the distribution, marketing, and transportation of processed foods, and 
mass catering establishments, G/TBT/N/ECU/490  (ID 6896) 
4.23.   The representative of the United States  provided the fo llowing statement. The United States 
appreciates the opportunity to discuss Ecuador's draft sanitary technical regulation, establishing 
registration and certification requirements for processed retail food, notified as G/TBT/N/ECU/490 . 
We thank Ecuador for their response in Februar y 2021 to the US Government's comments. On 
24 March 2021, the United States requested a Spanish version of Ecuador's response to US  
comments. Could Ecuador provide the response in Spanish for a clearer interpretation? The United 
States observes that Ecuado r shall require US manufacturers to provide a health certificate for all 
processed foods. The United States would like to note that some processed foods are especially 
highly processed, shelf -stable products that pose relatively minimal food safety risks. Therefore, 
please explain its scientific rationale for requiring a health certificate for all processed food products.  
 
5 For previous statements follow the thread under ID 688 . 
6 For previous statements follow the thread under ID 689 . G/TBT/M/84  
 
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  4.24.   The United States would like to note that a Certificate to a Foreign Government, issued by 
the US Food and Drug Administration (FDA), ind icates that exported foods meet US regulatory 
requirements, including processing according to Good Manufacturing Practice regulations. Can 
Ecuador please confirm that a US FDA -issued Certificate to a Foreign Government would satisfy 
Ecuador's health and go od manufacturing practice requirements? The measure states the Good 
Manufacturing Practice certification are carried out by an inspection body accredited by the 
Ecuadorian Accreditation Service (SAE). Could Ecuador confirm that the FDA Certificate to a For eign 
Government, which is issued by a competent authority, is sufficient and does not require 
accreditation? Please clarify the implementation timeline for this draft regulation. The United States 
looks forward to continuing the dialogue with Ecuador about  developing regulations in a manner that 
addresses Ecuador's health concerns while continuing to facilitate trade. Our regulators and technical 
experts are available to share more information on our regulatory approach. Would Ecuador be 
interested in havin g a technical exchange in this area?  
4.25.   In response, the representative of Ecuador  provided the following statement. The replies to 
the United States' concerns were transmitted to the US delegation this morning. I would, however, 
like to make the following co mments . The draft "Substitute Sanitary Technical Regulation on 
processed foods, processing plants, establishments for the distribution, marketing and 
transportation of processed foods, and mass catering establishments" is still being drawn up and 
analysed at the technical level.  Our National Agency for Sanitary Regulation, Control and Surveillance 
has provided detailed replies to the comments sent by the United States, in Spanish and English.  
The information provided indicates the time frame for the impleme ntation of this draft regulation, 
which takes into account public consultation periods in accordance with the Agreement on Technical 
Barriers to Trade.  Our regulators and technical experts are available to provide further information 
on our regulatory appr oach.  My country welcomes the opportunity to learn about the regulatory 
approach of the United States.  Therefore, in order to arrange a technical exchange regarding 
registration and certification and to address the concerns raised by the United States, our  capital 
will facilitate a meeting between our technical authorities and the technical authorities of the United 
States.  
4.1.2.6   European Union - Chemical strategy for sustainability (implementation of the 
European Green Deal) (ID 6907) 
4.26.   The representative of the Russian Federation  provided the following statement. On 14 October 
2020, the European Union published Chemicals Strategy for Sustainability. The Strategy is part of 
the European Green Deal. Implementation of Strategy can have significant worldwide trade -
distorting effect in a wide range of economic sectors. Although the Strategy is a non -binding 
document, it is a strong political commitment which involves plans to tighten even further current 
regulation of chemical substances and mixtures under the CLP/Reac h Regulations as well as other 
product specific regulations. The Russian Federation would like to raise the following concerns in 
respect of this Strategy and its implications for foreign trade. First, the EU's legislation, specifically 
REACH/CLP, employs precautionary principle which implies strict classification decisions without 
available laboratory or epidemiological data. One recent example of this practice is cobalt 
classification under the 14th Adaptation to Technical and Scientific Progress of the E U Classification, 
Labelling and Packaging Regulation. The Strategy implies banning the use of the "most harmful 
chemicals ", classified under this category in the CLP Regulation. This situation will entail restrictions 
and prohibitions of safe substances cl assified unjustifiably strictly using precautionary principle. The 
EU sticks to the position that once relevant scientific data is available the classification decision can 
be revised. However, such revision will have little practical implications since ma nufacturers of 
prohibited products would stop production, revise technological processes or even go out of business.  
4.27.   In this context, we request that the EU answer the following questions. Could the  EU explain 
how described situation is supposed to be miti gated? Could the EU elaborate how such an approach 
complies with the provisions of the Agreement on TBT bearing in mind the requirements of scientific 
justification in Article 2.2 of this Agreement? Will the EU ban substances only in case of their use 
leading to actual risks? Second, the Strategy introduces the new categories of chemicals, i.e. most 
harmful chemicals and substances of concern while category of substances of very high concern is 
already incorporated in the REACH regulation. Could the EU elab orate on the differences between 
these three categories? Could the EU explain why the current version of the CLP/REACH legislation 
is not sufficient to fulfill protection of human health objective? Third, the Strategy implies the plans 
 
7 For previous statements follow the thread under ID 690 . G/TBT/M/84  
 
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  to introduce new inf ormation requirements to the REACH (for example, for endocrine disruption, 
immunotoxicity, neurotoxicity, carcinogenicity at all tonnage levels, etc.). Could the EU explain why 
these new requirements are not more trade restrictive than necessary? Finally, could the EU inform 
if legal acts implementing Strategy  have already been developed?  
4.28.   The representative of the United States  provided the following statement. The United States 
continues to closely follow the EU 's proposed Chemicals Strategy for Sustainabi lity (CSS).  While the 
US supports the EU 's intent to better protect human health and the environment, we remain 
concerned about the potential trade implications of the CSS.  We note the establishment of the "High-
Level Roundtable Group " and continue to encourage the Commission to conduct meaningful 
stakeholder engagement, including with third countries, on the Strategy. We also ask the 
Commission to perform thorough impact assessments to understand the economic and trade 
implications in advance of all actions proposed in the Strategy. Finally, we ask the Commission to 
keep stakeholders updated with regards to the consultation and implementation timetable for the 
Strategy.  
4.29.   The representative of India provided the following statement. We appreciate and understand 
the intent of the EU Green Deal and the chemical strategy  for sustainability. Having said that, we 
are also  concerned about the trade implications and hence we thank  the Russia n Federation  for 
raising this concern and we  remain inte rested in the development  and answers that the European 
Union has to give to the concerns raised . 
4.30.   In response, the representative of the European Union  provided the following statement. The 
European Union would like to recall that the EU Chemicals Strategy  for Sustainability was adopted 
on 14 October 2020. The Strategy is the first step towards a zero pollution ambition for a toxic -free 
environment announced in the European Green Deal. The objective of the Strategy is thus to boost 
innovation for safe and s ustainable chemicals, and increase protection of human health and the 
environment against hazardous chemicals. This includes prohibiting the use of the most harmful 
chemicals in several consumer products such as toys, cosmetics and textiles, unless proven essential 
for society, and ensuring that all chemicals are used more safely and sustainably. The Chemicals 
Strategy aims at an increased protection of consumers and vulnerable groups by not allowing the 
most hazardous chemicals in consumer products, childc are articles and for professional uses, except 
for essential uses. This is a generic approach to risk management, which recognizes that exposure 
to chemicals in those products and uses cannot be easily controlled.  
4.31.   The European Union would like to clarify t hat the generic approach to risk management is not 
a new approach in the EU chemicals legislation, and is consistent with WTO rules as it is based on 
risk considerations, including the available scientific and technical information on the properties of 
the concerned substances and the intended end -uses of products. This approach is already in use in 
consumer products for chemicals that cause cancer or that are toxic for our reproductive system. 
The Strategy only proposes to extend this approach to other haz ard classes, such as endocrine 
disruptions, to further protect consumers and children as well as the environment. The way this 
approach will be extended and the associated impacts will be assessed under the revisions of the 
relevant pieces of legislation, in particular REACH and other product -specific pieces of legislation 
(e.g. legislation on food contact materials). Those assessments will follow the European 
Commission's Better Regulation guidelines and will be based on updated scientific information and 
on the feedback of all relevant stakeholders. Moreover, regarding the Regulation on Classification, 
Labelling and Packaging (CLP), the European Commission will propose a targeted revision in order 
to achieve the objectives of the Chemicals Strategy and in particular to ensure that the CLP 
regulation fully fulfills its main objective: appropriate classification of the hazardous properties of 
substances according to the best scientific knowledge and available data. To this goal, the European 
Commission will p ropose new hazard classes and criteria in particular on endocrine disruptors and 
to fully address environmental toxicity, persistency, mobility and bioaccumulation. However, the 
way the classified substances or mixtures are dealt with will depend on other pieces of legislation 
(in particular, REACH and specific products legislation); this will be designed and assessed within 
specific sectorial impact assessments, according to the European Commission's Better Regulation 
guidelines.  
4.32.   The European Union would a lso like to recall that the CLP Regulation already includes a 
possibility to review an adopted classification. Economic operators who have new information which 
may lead to a change of the harmonized classification and labelling can in fact submit a revisi on 
proposal to a competent authority in one of the member States. The authority can then decide to G/TBT/M/84  
 
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  officially submit a proposal to reassess the classification. The European Union would further like to 
clarify that the Chemicals Strategy does not introduce a new category for "most harmful substances". 
However, the following hazard categories of substances have been found from recent policy 
evaluations and scientific evidence to be the most harmful, in particular for consumers: chemicals 
that cause cancers, g ene mutations, affect the reproductive or the endocrine system, or are 
persistent and bioaccumulative, chemicals affecting the immune, neurological or respiratory systems 
and chemicals toxic to a specific organ. Substances of concern are defined in the Str ategy as those 
substances having a chronic effect for human health or the environment (as for Candidate  list in 
REACH and Annex VI to the CLP Regulation) but also those which hamper recycling for safe and high 
quality secondary raw materials. The category of Substances of Very High Concern (SVHC) is a 
specific category under REACH (not applied in other pieces of EU chemicals legislation) to list those 
substances whose use is proposed to be subject to authorization. The European Commission will 
propose to introduce endocrine disruptors, persistent, mobile and toxic and very persistent and very 
mobile substances as categories of substances of very high concern, as part of its proposal for the 
revision of REACH. Also, the  Strategy has announced that the Europea n Commission will assess 
options to improve the overall authorization and restriction processes under REACH.  
4.33.   The Strategy aims to consolidate and strengthen the current EU legal framework on chemicals, 
not to establish new approaches. In particular, the Eu ropean Commission's proposals aim to speed 
up the regulatory management of the most harmful substances, as the current approaches have 
been found too slow to protect consumers, professional users and the environment against risks 
from those substances. Fur thermore, the European Commission will propose to revise information 
requirements in REACH in order to ensure sufficient information for the scientific assessment of 
those substances, in line with the objectives set in the Chemicals Strategy. This will aff ect equally 
manufacturers located in the EU and importers of substances from outside the EU; thus the same 
rules will apply. The exact proposal and its impacts will be assessed during the impact assessment 
for the revision of REACH, according to the Europe an Commission's Better Regulation guidelines. 
Finally, the European Union would like to clarify that the European Commission is currently 
implementing the Strategy and in preparing the necessary legal proposals. Those will concern mostly 
the revision of ch emicals legislation already in place. The only new piece of legislation proposed will 
be a founding regulation for the European Chemicals Agency (ECHA). In May 2021, two Inception 
Impact Assessments were published, or so -called roadmaps, one on the revisio n of the EU CLP 
Regulation and one on the revision of the EU REACH Regulation. These roadmaps were open for 
stakeholder feedback until 1 June 2021. Both roadmaps provide overall descriptions of the problems 
that need to be solved, possible options for how changing the two pieces of legislation may help to 
solve these problems as well as initial assessments of the potential impacts of such changes. The 
feedback on both roadmaps will be used to further develop and fine -tune each initiative. After 
assessing th e responses to the roadmaps, another round of public consultations will be launched to 
gather more specific and more in -depth feedback. The open public consultations for three months 
for the revision of the CLP Regulation is expected to be launched in Q4 2 021, and for the REACH 
Regulation late 2021 and running into 2022. They will be available on the "Have -your-say" portal 
and will also be referred to on the Commission's webpage for the Chemical Strategy for 
Sustainability. In terms of engagement with stake holders and WTO Members, the European Union 
would recommend to provide feedback during the foreseen public consultations. Moreover, the 
European Union would like to reiterate that any legislative proposal put forward in the context of the 
EU Chemicals Stra tegy for Sustainability, including the proposals for the revision of the CLP and 
REACH Regulations, will be notified in accordance with the TBT Agreement.  
4.1.2.7   Republic of Korea - Amendment of particular requirements for appliances for 
heating liquids (KC 60335 -2-15), G/TBT/N/KOR/939  (ID 6918) 
4.34.   The representative of China  provided the following statement. We suggest that pot with 
rubber sealing ring meets I EC safety standards and can be designed as a pressure safety device. It 
is suggested that KC 60335 -2-15 be consistent with IEC 60335 -2-15. 
4.35.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to deliver the official response from the regulatory authority. This WTO TBT 
notification ( G/TBT/N/KOR/939 ) is in regard to the revision of "particular requirements for  appliances 
for heating liquids (KC 60335 -2-15)" such as rice cookers. Korea would like to respond to China's 
request for the requirement in Clause 22.107 "rubber packing is not considered a pressure safety 
 
8 For previous statements follow the thread under ID 691 . G/TBT/M/84  
 
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  device" to be harmonized with the international s tandards (IEC 60335 -2-15). This requirement 
applies only to domestic standards in Korea, and was introduced following incidents of electric rice 
cooker explosion in Korea in 2004. Furthermore, the requirement was made by taking into 
consideration consumer safety in Korea, a country in which an electric rice cooker is present in 
almost every household. Against this backdrop, this requirement entered into effect upon the 
revision of the KC60335 -2-15 Safety Standards on 2 August 2004. However, this phrase has thus 
far been omitted due to the amended requirement during the KS standard matching work on 
23 September 2015. However, consumers can easily buy and replace rubber packing, which is a 
consumable item that may harden during use. In addition, we have reache d the conclusion that 
rubber packing cannot be considered an appropriate pressure device based on opinions gathered 
from related industries, test and certification bodies that long -term use leads to a greater risk of 
reduced safety. Therefore, we would lik e to inform China that as a result of the inclusion of this 
phrase, this revision will in fact strengthen domestic safety standards for consumer safety.  
4.1.2.8   Canada - Concentration of Nicotine in Vaping Products Regulation, 
G/TBT/N/CAN/633  (ID 6929) 
4.36.   The representative of Japan  provided  the following statement. Regarding Canada's proposed 
regulations on concentration of nicotine in vaping products, notified on 5 January 2021, while Japan 
respects their policy objectives, Japan has a concern whether Canada will allow a "reasonable 
interva l" between the publication of the regulations and their entry into force in accordance with 
Article 2.12 of the TBT Agreement. Canada currently proposes "15 days " as the interval. However, 
Japan considers it is difficult for some producers and distributors of vaping products to remove 
newly -regulated products from their global supply chains in such a short period of time, and it could 
lead to disruptions in the Can adian market. Furthermore, we are strongly concerned that such a 
short interval would become the standard in the Canadian rulemaking process even though Doha 
Ministerial Decision, WT/MIN(01)/17 , describes "reasonable interval " as normally "not less than 6 
months ". For these reasons, Ja pan would like Canada to fully consider concerns from stakeholders 
and respect WTO rules in the process of finalizing the regulations to the extent possible.  
4.37.   In response, the representative of Canada  provided the following statement. We would like 
to thank  the delegation of Japan for their intervention. Canada believes that, with respect to the 
present measure, Canada respected its international obligations under the TBT Agreement and was 
able to strike the appropriate balance between pursuing a legitimate public policy objective – which 
is the protection of public health, and in this case, the health of young Canadians – and providing 
producers in exporting countries time to adapt to requirements of the measure. Canada appreciated 
Japan's openness to meet b ilaterally with Canada, which allowed for a positive exchange of views 
and information on the measure concerned. Canada remains available for further bilateral 
engagement with Japan on this issue.  
4.1.2.9   Chile - Amendment to the general regulation of the compulso ry system for 
livestock classification and the grading, marking and marketing of beef, 
G/TBT/N/CHL/544  (ID 69310) 
4.38.   The representative of Brazil  provided the following statement. Brazil would like to express its 
concerns regarding Chilean draft regulation G/TBT/N/CHL/544 , which aims to amend the general 
regulation of the compulsory system for livestock classification and the grading, marking and 
marketing of beef. This pro posal provides for the application of a compulsory stamp to be used 
exclusively for meat from animals born, reared, and slaughtered in Chile, and two voluntary stamps 
that may only be used on meat that already has the compulsory stamp. Brazil understands t hat the 
use of quality stamps that are exclusive to national producers may create discriminatory marketing 
conditions in favour of Chilean producers. The measure also seems to be more trade restrictive than 
necessary to pursue Chilean legitimate policy obj ectives. If this draft is adopted as a final regulation, 
meat produced abroad with the same amount of fat content or other similar characteristics compared 
to Chilean meat will be denied the possibility of receiving both mandatory and voluntary stamps, 
which will give rise to discrepancies in consumers' quality perception. Chilean regulation could also 
constitute a violation to Article 2.1 of the Agreement on Technical Barriers to Trade, which states 
that "Members shall ensure that in respect of technical r egulations, products imported from the 
territory of any Member shall be accorded treatment no less favourable than that accorded to like 
 
9 For previous statements follow the thread under ID 692 . 
10 For previous statements follow the thread under ID 693 . G/TBT/M/84  
 
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  products of national origin and to like products originating in any other country ". In light of the 
above, we kindly as k Chile to explain what legitimate objectives it is willing to safeguard with said 
regulation, as well as the link between these objectives and the proposed measure. Also, we 
encourage Chile to present other less trade -restrictive alternatives it considere d prior to proposing 
the draft regulation.  
4.39.   In response, the representative of Chile provided the following statement. Chile thanks the 
Federative Republic of Brazil for its submission regarding notification G/TBT/N/CHL/544 . The Chilean 
Ministry of Agriculture is indeed amending Dec ree No. 239 on the general regulation of the 
compulsory system for livestock classification and the grading, marking and marketing of beef, in 
respect of which comments were received from Brazil and other countries, with work underway to 
duly address these  comments.  
4.1.2.10   European Union - Withdrawal of the approval of the active substance alpha -
cypermethrin, G/TBT/N/EU/770  (ID 69411) 
4.40.   The representative of Brazil  provided the following statement. Brazil would like to express its 
concerns related to notification G/TBT/N/EU/770  regarding the Commission Implementing 
Regul ation proposal to withdraw the approval of the active substance alpha -cypermethrin. Alpha -
cypermethrin is registered in Brazil as an insecticide against important pests that damage a variety 
of crops, including soy, cotton, corn, citrus, watermelon, peanut , coffee, among other products 
exported to the European Union. In relation to these crops, our national health agency has set MRLs 
for alpha -cypermethrin of 0.05mg/kg, 0.15mg/kg, 0.05mg/kg, 0.3mg/kg, 0.05mg/kg, 0.05mg/kg 
and 0.3mg/kg, respectively. If the register of said substance is withdrawn and MRLs are 
automatically reduced, it would significantly affect the income of Brazilian farmers, especially citrus 
producers, since the substance is essential to control greening, a disease affecting citrus orchard s 
worldwide. Greening has been recognized by EFSA itself as a priority pest for control, according to 
the Commission Delegated Regulation (EU) 2019/1702. The Brazilian citrus industry plays an 
important role in generating jobs in the countryside. Export of  orange juices to the European market 
represented almost USD 1 billion of exports in the 2019 -2020 marketing year. Alpha -cypermethrin 
is also an important component to conduct integrated pest management, once it may be combined 
with other insecticides to c ontribute to increase their useful life, ensuring efficient pest control and 
maintaining the sustainability of crop production. In light of the above, in case the register of the 
substance is withdrawn, Brazil would like to kindly encourage the EU to adopt  MRLs for imported 
products in accordance with the limits set by Codex Alimentarius.  
4.41.   The representative of Paraguay  provided the following statement. Paraguay appreciates the 
opportunity to comment on notification G/TBT/N/EU/770  (draft Commission Implementing 
Regulation withdrawing t he approval of the active substance alpha -cypermethrin in accordance with 
Regulation (EC) No. 1107/2009) and supports the concern expressed by Brazil on this draft 
Regulation.  It should be noted that, in 2020, Paraguay imported approximately 80,000 kilogra ms of 
the substance alpha -cypermethrin, which is duly registered as a systemic insecticide with the 
competent authority, the National Plant and Seed Quality and Health Service (SENAV E), and is used 
to control pests that attack crops of great economic impor tance. Pests controlled by the affected 
substance include: Spodoptera frugiperda  in maize and soybean crops, Anticarsia gemmatalis  
(velvetbean caterpillar), Loxostege bifidalis  (green caterpillar), Epinotia aporema  (bud borer) in 
soybean crops, Horcias nobilellus  (cotton bug), Alabama argillacea  (cotton leafworm) and 
Porosagrotis gypaetina  (brown cutworm) among other Lepidoptera, Hemiptera and insects that 
attack crops such as cotton, maize and sunflower. In this regard, these insects pose a real  problem 
for the development of a number of crops, and it is therefore important to possess duly controlled 
and authorized substances that have met the technical and scientific requirements for use and have 
proven both effective in controlling these pests and vital for the rotation of active ingredients, 
thereby preventing insect resistance as part of the integrated management of pests.  
4.42.   Paraguay considers that the withdrawal of this substance by the European Union could 
significantly restrict local producer s in terms of the technological substances available for the proper 
management of their crops, thus having a direct impact on the national economy.  Our concern 
therefore is founded on the negative impacts that this measure would have on Paraguayan 
producer s, bearing in mind the importance of the crops on which alpha -cypermethrin is used and its 
impact on the domestic exports on which it is used. While it is recognized that Members have the 
 
11 For previous statements follow the thread under ID 694 . G/TBT/M/84  
 
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  right to determine the appropriate level of sanitary or phytosanitar y protection necessary to protect 
human, animal or plant life or health, we are of the view that this measure is inconsistent with 
Article  2.2 of the TBT Agreement as it generates unnecessary trade restrictions.  Paraguay insists 
that the lack of risk asses sment 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. It is important to adopt a science - and risk -based 
approach for regulating plant protection products and we consider that the European approach to 
limit the use of pesticides is more trade -restrictive than necessary to fulfill its legitimate objectives 
under the TBT Agreement.  
4.43.   The representati ve of Colombia  provided the following statement. We would like to register  
our interest in this STC and thank Brazil  for raising this issue. We note particularly the concern that 
this EU standard  creates in the use of this substance  in citrus crops in Col ombia as well as its 
insecticide qualit y which allow s it to be used on a broad range  of products . It is noteworthy that 
tropical climate countries such as Colombia r ely heavily on these substances  to ensure there is 
effective control of pests and insects in  their crops.   
4.44.   In response, the representative of the European Union  provided the following statement. The 
approval of alpha -cypermethrin had to be withdrawn, as the Commission Implementing Regulation 
that renewed its approval in 2019 included the condition that the applicant had to submit 
confirmatory information as regar ds the toxicological profile of certain metabolites by 30 October 
2020. In addition, confirmatory information had been required for three other points by other 
deadlines. However, in October 2020, the applicant informed the Commission that it would not 
submit any confirmatory data. Therefore, as the information required in accordance with Article 6(f) 
of Regulation (EC) No 1107/2009 on plant protection products was not submitted and the applicant 
had clearly stated that he will not fulfill his regulatory ob ligations, the approval for alpha -
cypermethrin had to be withdrawn according to Article 21(3) of Regulation (EC) No 1107/2009. 
Following the withdrawal decision, the EU will prepare a draft Regulation to lower the existing 
Maximum Residue Limits (MRLs) for  alpha -cypermethrin to the limit of quantification, and will notify 
it to the WTO/SPS Committee. The procedure for the lowering of the current EU MRLs will not 
commence before expiry of the grace periods for use of products containing alpha -cypermethrin. 
Whether MRLs currently established based on earlier import tolerance requests or based on Codex 
MRLs will remain unchanged, will depend on the outcome of the forthcoming MRL review of the 
group of cypermethrins by the European Food Safety Authority (EFSA), planned to be launched in 
2021. If Brazil and other Members consider it necessary to ensure that MRLs for alpha -cypermethrin 
on relevant crops remain or should be newly set at higher/different levels, they may wish to submit 
an application for setting impo rt tolerances according to Article 6 of Regulation (EC) No 396/2005 
on maximum residue levels of pesticides in or on food and feed of plant and animal origin. If 
submitted early enough, the application will be thoroughly assessed by EFSA at the same time a s 
the review of the group of cypermethrins mentioned above and, if the data provided are complete 
and there is no risk for consumers, such an import tolerance can be established. The EU would like 
to invite Brazil to contact the relevant authorities in Bel gium, the rapporteur member State, and to 
ensure that the necessary information will be available in due time for the evaluation by the 
rapporteur member State and EFSA.  
4.1.2.11   Colombia – Biofuels Decree – Resolution No. 40111 of 9 April 2021 (ID 69512) 
4.45.   The repre sentative of the European Union  provided the following statement. The EU would 
like to present its remarks pertaining to the non -notified measure, the Regulation No. 40111 of 
9 April 2021, establishing maximum content of fuel alcohol – ethanol in the  mixtu re with regular and 
extra gasoline at national level and the maximum biofuel content in the mixture with fossil diesel 
fuel at the national level. The EU would like to recall that according to Article 2.9.2 of the TBT 
Agreement, the proposed technical regu lations should be notified at an early appropriate stage, 
when amendments can still be introduced and comments taken into account. Given that Colombia 
adopted the measure in question, failing to comply with its TBT obligation of notification at draft 
stage , the EU calls on Colombia to suspend the measure and to notify it, respecting the provisions 
of the TBT Agreement, and providing WTO Members sufficient time to submit comments. In any 
case, the EU would like to take this opportunity to indicate to Colombi a that blends higher than B7 
may render it impossible to meet high emission standards such as euro 6 or euro 7, as well as euro 
VI and euro VII. In some cases, such blends can also reduce the duration of the after -treatment 
 
12 For previous statements follow the thread under ID 695 . G/TBT/M/84  
 
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  systems, thereby increasing the actual emissions from the vehicles. If the combination of fuels 
available and mandatory emission limits in Colombia would require a specific vehicle production for 
Colombia, this would result in a reduced availability of vehicle models at higher prices in Colombia.  
4.46.   The European Union would like to invite Colombia to share with the EU the tests and studies 
performed to ensure that the vehicles will be able to meet the envisaged emissions limits without 
damaging their power and after -treatment systems. The EU  would also like to ask Colombia to 
significantly delay the entry into force of the Regulation in order to allow the necessary time for 
vehicle producers to adapt to new requirements. The EU would like to suggest that for several years 
Colombia continues o ffering B7 biodiesel for the existing car park. The European Union calls on 
Colombia to notify the Regulation in line with the provisions of the TBT Agreement, and to give 
Members sufficient time to submit comments.  
4.47.   In response, the representative of Colom bia provided the following statement. The delegation 
of Colombia thanks the European Union (EU) for sharing its observations and submits the following 
comments . Resolution 40111 of 2021 is based on the Política Nacional de Producción de 
Biocombustibles  (National Biofuels Production Policy), and the basic premises underpinning it. In 
CONPES document No.  3510 of 31  March  2008 on the "Policy guidelines for promoting the 
sustainable production of biofuels in Colombia", the following was one of the specific obje ctives on 
promoting biofuels production: "To diversify the country's energy mix through the efficient 
production of biofuels, making use of current and future technologies". Article 1.2 of Decree No.  4892 
of 2011, compiled in article 2.2.1.1.2.2.3.111 of D ecree No.  1073 of 2015, provided that the Ministry 
of Mines and Energy and the Ministry of the Environment and Sustainable Development, after 
consultation with the Intersectoral Commission on Biofuels, may set mandatory percentages above 
10% for biofuels f or use in diesel engines.  In light of the above, in 2018 the Office of the President 
gave the impetus to go ahead with increasing the blend of diesel with biodiesel in the country. 
Working groups met under the auspices of the Intersectoral Commission on Bi ofuels, in compliance 
with the provisions of the above -mentioned decree. These round tables concluded that, based on 
the national study on biofuel supply, in addition to the air -pollutant -reducing effects of the use of 
biodiesel for a 12% blend level under  sustainable practices in the life cycle, it is feasible to regulate 
a mandatory maximum blend level of 12% of biodiesel with fossil diesel for Colombia.  As a result, 
in order to address the concerns raised by the EU, a meeting between our technical author ities and 
the EU technical authorities would be facilitated from our capital.  
4.1.2.12   Argentina - Requirement of affidavit along with the product certification from a 
certified body for export of boards derived from wood (ID 69613) 
4.48.   The representative of India provided the following statement. Argentina has notified the 
requirement of an affidavit in addition to a product certification from a certified body for the export 
of boards derived from wood. India thanks Argentina for its notification G/TBT/N/ARG/342/Add.6  
dated 22 Febru ary 2021 on the proposed draft Resolution "Technical quality and safety requirements 
applicable to boards derived from wood". As per Article  2 of the Draft Resolution, besides product 
certification, an affidavit from a certified body indicating compliance to the requirements is required. 
India has submitted its queries to Argentina's enquiry point seeking relevance of an affidavit 
indicating a product's compliance, mainly when a certification requirement is already in place. India 
believes that the addition al requirement of an affidavit will add both to the cost and procedural 
burden for exporters, thereby adversely affecting the competitiveness of the product in Argentina. 
Further, no risk assessment for the additional requirement of an affidavit is shared by Argentina.  
4.49.   As per Article 2.2 of the TBT Agreement: "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, techn ical regulations shall not be more trade -restrictive than 
necessary to fulfill a legitimate objective, taking account of the risks non -fulfillment would create". 
Further, as per Article 2.3 of the TBT Agreement: "Technical regulations shall not be maintain ed if 
the circumstances or objectives giving rise to their adoption no longer exist or if the changed 
circumstances or objectives can be addressed in a less trade -restrictive manner". Hence, prima facie  
Argentina's requirement of an affidavit in addition t o certification requirement appears to be trade 
restrictive. It is also not known what other less trade -restrictive or alternative measures were 
considered by Argentina before deciding on the present measure. Given the above, Argentina is 
requested not to impose the additional affidavit requirements, to respond to the queries submitted 
 
13 For previous statements follow the thread under ID 696 . G/TBT/M/84  
 
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  by India to its enquiry point and if it cannot do away with the additional affidavit requirements, share 
the risk assessment done in arriving at the imposing such a trade -restrictive measure.  
4.50.   In response, the representative of Argentina  provided the following statement. Argentina 
thanks the delegation of India for its questions and comments with regard to Argentina's notification 
in document G/TBT/N/ARG/342/Add.6  of 22 February 2021 concern ing the "Technical quality and 
safety requirements for wood -based boards" and other provisions.  In this connection, we wish to 
point out that Secretariat of Domestic Trade (SCI) Resolution No.  240/2019 and the amendment 
thereto, and SCI Resolution No. 428/ 2021 establish three distinct and non -overlapping stages for 
the fulfillment of the technical requirements that they lay down and that seek to ensure compliance 
with the appropriate quality and safety standards deriving from a number of specific standards of 
the Argentine Standards and Certification Institute (IRAM).  In the first stage, both domestic 
manufacturers and importers must prepare an affidavit that demonstrates compliance with the 
requirements of these reference standards, and provide laboratory t est reports as supporting 
documentation. In the second stage, proof of initiation of the certification process is needed. Lastly, 
a certificate issued by a certification body is required from the third stage.  As I previously stated, 
these stages do not ove rlap. In other words, the affidavit stage ends once the certification stage 
takes effect and the submission of this affidavit will no longer be accepted.  In conclusion, I wish to 
inform the distinguished delegation of India that the Argentine Focal Point h as no record of India's 
question. As a result, on 31 May, we asked the Indian Focal Point to resend the comments submitted.  
We hope that these clarifications are useful to the Indian delegation and remain open to any other 
questions.  
4.1.2.13   Colombia – Good manufa cturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 69714) 
4.51.   The representative of the European Union  provided the following statement. The European 
Union would like to thank Colombia for its reply of November 2020 to the EU written comments and 
for the extensive bilateral discussions and hopes that the Decree no 162 published on 16 February 
2021 will not  create unnecessary burdensome requirements for EU exporters of wines and spirits. 
The European Union notes that Article 3 of the adopted decree refers to the possibility to present 
alternatives to the Good Manufacturing Practices certificate upon import t o Colombia. EU exporters 
of wines and spirit drinks already comply with the existing obligation to submit Free Sales Certificates 
for sanitary register. The Free Sales Certificates state that the product is compliant with the EU 
legislative requirements, w hich encompass Good Manufacturing Practices. The European Union 
therefore considers that Free Sale Certificates issued by EU member States would comply with the 
Colombian requirement to provide Good Manufacturing Practices certificate upon import. The 
European Union would, therefore, like to ask Colombia to confirm this interpretation. The European 
Union is prepared to continue the bilateral work should there be any need for additional clarifications.  
4.52.   In response, the representative of Colombia  provided the  following statement. Colombia 
thanks the EU for bilateral discussions. Decree No.  162 of 2021 was issued because there was a 
need to move forward in optimizing the existing regulation in order to establish conformity with good 
manufacturing practices (GMP ) certification for manufacturers located outside the national territory, 
given that Decree No.  1686 of 2012 already established certification for domestic manufacturers but 
did not provide importers with the option of such conformity, and thereby ensure e qual conditions 
for both parties.  In this regard, Article 3.2 of the decree in question provided that establishments 
located outside the national territory where alcoholic beverages are produced and imported into the 
country must comply with GMP, a require ment that must be supported by one of the following 
documents:  "(a) Certificate of good manufacturing practices (GMP), from the manufacturing and/or 
packaging establishment, issued by the relevant authority of the country of origin, by the accredited 
certification body or by the authorized third party in the country of origin.  (b) Hazard Analysis and 
Critical Control Point (HACCP) System certificate or document supporting its implementation, issued 
by the relevant authority of the country of origin, by the accredited certification body or by the 
authorized third party in the country of origin of the product.  (c) Certification issued by the relevant 
authority, by the accredited certification body or by the authorized third party in the country of origin 
of the product, stating that the alcoholic beverage and the producer should comply with the technical 
standards, processes or procedures or are subject to monitoring and inspection.  (d) Certificate of 
good manufacturing practices of the manufacturing and/or pac kaging establishment, issued by the 
 
14 For previous statements follow the thread under ID 697 . G/TBT/M/84  
 
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  Instituto Nacional de Vigilancia de Medicamentos y Alimentos , INVIMA (National Food and Drug 
Surveillance Institute)."  
4.53.   Stakeholders should evaluate each of the above options and apply one of them in order to 
comply. In t his regard, the Certificado de Libre Venta , CVL (Certificate of Free Sale) may still be 
used, as long as it states that the alcoholic beverage and the producer comply with the technical 
standards, processes or procedures established in the country of origi n. Taking the above into 
account, the Ministry of Health and Social Welfare, together with INVIMA, have undertaken working 
sessions with EU representatives with the aim of providing guidance on the compliance options 
described in Decree No.  162 of 2021. Co lombia will continue to facilitate these bilateral technical 
meetings to clarify aspects of the content of the regulation.  Lastly, it must be mentioned that the 
establishments producing alcoholic beverages located inside and outside the national territory will 
have until 14  February  2023 to comply with the good manufacturing practices certification as per 
Article 3, bearing in mind that the validity of the certificates already granted by the INVIMA will be 
extended for two (2) more years.  
4.1.2.14   Kingdom of Saudi Arabia - Technical Regulation for Building Materials – Part 4: 
Bricks, Tiles, Ceramics, Sanitary Appliances, and related products (published on the 
official gazette on 22/03/2019), G/TBT/N/SAU/993,  G/TBT/N/SAU/993/Rev.1  (ID 
69815) 
4.54.   The representative of the European Union  provided the following statement. The European 
Union is strongly concerned by the difficulties related to the implementation of the Technical 
Regulation for Building Materials and in particular the Saudi Quality Mark (SQM). Since the 
establishment of the SQM, t he European companies are facing important challenges that have 
resulted in a de facto  quantitative restriction to imports. The European Union would like to reiterate 
the following points, which represent a major concern. Audits are disproportionate and ex ceed 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 require 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.  
4.55.   High Costs . According to the data available, this certificat ion is not only one of the most 
expensive certification 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 producers from the market, as most of them are SMEs. Limited number of Cert ification 
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 compani es. Unclear audit procedures . SASO has never published 
a list of documentation required for the audit; hence, there is no standardized procedures and there 
can be discrepancies in the audit requirements set out by different Certification Bodies. As a resul t, 
the SQM procedures are unpredictable and applicants are subject to different conditions based on 
the Certification Body they utilise. Yearly Surveillance Audits . The yearly renewal of the SQM should 
entail less requirements due to its surveillance natur e. 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 conclusion, the European Union would like to invite the Kingdom 
of Saudi Arab ia to ensure that the Saudi Quality Mark will not constitute a barrier to trade. The 
European Union remains available to discuss this issue with the Saudi authorities also bilaterally.  
4.56.   In response, the representative of the Kingdom of Saudi Arabia  provided  the following 
statement. Saudi Arabia would like to express its appreciation for the concerns addressed by the EU, 
and for their valuable comments on Technical Regulation for Building Materials – Part 4: Bricks, 
Tiles, Ceramics, Sanitary Appliances, and r elated products, and we would like to provide the 
European side with clarification regarding the points mentioned in their above statement as follows. 
The audits process is carried out in accordance with the international standard ISO 17067 (type 5), 
which  requires compliance with all SASO ISO 13006 (adopted identically from ISO standard) 
standard items. Due to the difference in the size of dimensions and tolerance mentioned in the 
 
15 For previous statements follow the thread under ID 698 . G/TBT/M/84  
 
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  Standard ISO 13006 for rectified and non -rectified ceramic tiles, a test rep ort requires to state the 
compliance with the standard limits. The costs of obtaining the quality mark are based on 
international practices, and the same equal fees are applied for all companies without any 
discrimination. SASO has expanded the acceptance of authorized bodies in Europe in the field of 
ceramic tiles in order to facilitate the SQM process; the number of authorized bodies is five 
conformity assessment bodies listed as below: (i) SGS Societe General de Surveillance; (ii) TUV 
Austria Services GM BH; (iii) TÜV Rheinland LGA Products GmbH; (iv) UL International DEMKO A/S; 
(v) Intertek. The auditing requirements are clarified in the grant procedure for the ceramic tile 
product that is available in the certification system, and conducted by all author ized bodies in the 
same manner. All technical requirements are published for free on the SASO website. In yearly 
Surveillance  audits, the requirements are less than requirements in initial and renewal audits. 
Requirements are fixed for grants or renewals a udits.  
4.1.2.15   European Union - The specific test procedures and technical requirements for 
the type -approval of motor vehicles with regard to the driver drowsiness and attention 
warning systems, G/TBT/N/EU/771  (ID 69916) 
4.57.   The representative of China  provided the following statement. We sugge st that the EU : (i) add 
technical requirements of various technical routes in the regulation to better meet the needs of 
industrial technology development at this stage; (ii) increase the requirements and methods of 
systematic objective evaluation so as to quantify the events th at cause driver distraction from a 
safety perspective. The detailed suggestions are listed as follows. Part 1 : Regarding 2.3.1 "The 
DDAW system shall function in normal operation mode without the use of biometric information, 
including facial recognition, of any vehicle occupants ", the definition of "facial recognition " is too 
broad. The DDAW based on facial recognition will monitor the facial information to determine 
whether the driver is tired or not. It is suggested to determine which information cannot be used; 
does "the use of biometric information " mean to store or detect; and are blinking and yawning 
included in facial recognition. Regarding 3.1.4 "The DDAW system shall be automatically activated 
above the speed of 70 km/h ", the activation speed shall  be at least 70km/h, however, some 
commercial vehicles driving on non -highway usually can't reach speed. Hence, we suggest to lower 
the activation speed properly to make sure the monitoring can be realized in most driving courses.  
4.58.   Regarding 3.3.1 "The DDAW  system shall provide a warning to the driver at a level of 
drowsiness which is equivalent to 8 or above on the reference sleepiness scale set out in the 
Appendix (Karolinska Sleepiness Scale, hereinafter referred to as "KSS")." The DDAW system may 
provide  a warning to the driver at a level of drowsiness which is equivalent to level 7 on KSS. In 
addition, the manufacturer may implement an information strategy on the HMI prior to the warning. " 
Firstly, using KSS level as the fatigue analysis is subjective an d the alarm interval is ambiguous. 
Secondly, please explain the meaning and differences of the two concepts "information strategy " 
and "warning ", or give examples to illustrate what they contain. In 3.3.2 "a reduction in the number 
of micro -corrections wit hin driver steering, paired with an increase in the number of large and fast 
corrections ", there is no definition of the degree of reductions. The control strategies of each 
manufacturer will lead to a large difference in the time to determine fatigue. It is recommended to 
specify the amount of change, such as the percentage reduction of fine -tuning times. At the same 
time, there are no quantitative indicators for fine -tuning and rapid large -scale adjustment. We 
suggest to make it clear. Regarding "An alter native manner of measuring driver performance through 
vehicle systems analysis ("metrics") may be used, provided that it is an accurate and robust measure 
of driver drowsiness ", visual recognition of driver distraction is widely used in China. On the basis  of 
safety, requirements such as increasing driver's eyes closed for more than 2 seconds, head deflection 
exceeding the normal forward vision range for more than 3 seconds are given. When the driver's 
sight deflection exceeds the above threshold, an alarm should be issued. It is suggested that the 
European Union can refer to this quantitative indicator to put forward driver's distraction and fatigue 
requirements.  
4.59.   Regarding 3.4.1.1 "Visual, auditory and any other warning used by the DDAW system to alert 
the driver shall be presented as soon as possible after the occurrence of the trigger behaviour and 
may cascade and intensify until acknowledgment thereof by the driver ", the requirement of "as soon 
as possible " is too subjective. The regulation shall clearly define that the alert shall be presented 
within how many seconds after the drowsiness occurs since the alert in time is a key indicator to 
assure the safety of the system. The "Reference sleepiness scale for DDAW system (Karolinska 
 
16 For previous statements follow the thread under ID 699 . G/TBT/M/84  
 
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  Sleepiness Scale) " in Appendix to PART 1 is too subjective and has no objective evaluation indicator. 
Also, the whole part has no content of the scale of distraction. Distraction of attention involves 
fatigue. But drivers can be distracted for a long time (for example, they look left and right for a long 
time) without fatigue, which is also at greater risk.  
4.60.   Part 2  Regarding 2.1 and 2.2, DDAW is different from other systems. The use of human 
participants on real road tests is very dangerous since people might be injured. We suggest  the 
highly dangerous test on the real roads to be done in a closed testing area with relatively long tracks 
and a controllable environment.  Regarding 2.2, the operation of safety backup is difficult. As the 
method used to evaluate fatigue in this regulati on is too subjective, it is possible that there may be 
a difference between the two drivers' perceptions. If the driver is drowsy and the backup driver 
intervenes, the possibility of not reaching the system warning threshold may occur. If the 
intervention is only done with the warning presented, severe traffic accidents may already happen.  
Our general opinion for the 2nd point of PART 2 is to add a highly repeatable, highly consistent, and 
high safety validation scheme.  Regarding the 3rd point of PART 2, du e to the lack of objective 
comment of driver drowsiness, it is quite difficult to accurately evaluate the number of real events.  
Regarding "two raters and an inter -rater reliability test shall be conducted ", the methods of raters 
are too subjective to guar antee the consistency of ratings.  
4.61.   In response, the representative of the European Union  provided the following statement. The 
EU notes that China has also submitted detailed written comments to the EU TBT Enquiry Point on 
16 March 2021. In this regard, the  EU would like to reassure China that a reply will be sent in due 
course. Since the EU has not received any additional comments ahead of the Committee meeting, 
the EU hopes that our future written reply will sufficiently clarify China's comments. Therefore , the 
EU is confident that our continued dialogue can continue in writing.  
4.1.2.16   European Union - Uniform procedures and technical specifications for the type -
approval of motor vehicles with regard to their emergency lane keeping system (ELKS), 
G/TBT/N/EU/767  (ID 70017) 
4.62.   The representative of China  provided the following statement. We suggest that the following 
points be adjusted and explained in detail and that certain transitional periods be provided.  
Regarding 1.4 "changes to the steering angle of one or more wheels and/or braking of individual 
wheels may result from the automatic evaluation of signals initiated on -board the vehicle optionally 
enriched by data provided off -board the vehicle ", it defines the technical solution for lane 
maintenance by changing the steering ang le of one or more wheels and/or the braking of a single 
wheel in order to correct lane deviation. It is suggested to change to "control the lateral movement 
of the vehicle " because the purpose of ELKS is to keep and control the lane and the regulations sha ll 
not specify the technology used. Regarding 3.1.1.1 "There shall not be an appreciable time interval 
between each ELKS self -check (an integrated function that checks for a system failure on a 
continuous basis at least while the system is active), and sub sequently there shall not be a delay in 
illuminating the warning signal, in the case of an electrically detectable failure ", the ELKS is 
specifically required to perform two self -tests. We suggest that article 3.1.1.1 self -check requirement 
should be modif ied as "When turned on, the system should be capable of self -check, which means 
the system can check if the main electric components and sensors relevant to the system work 
normally ". The purpose of self -check is to make sure if the system can satisfy the fundamental 
running conditions and the number of self -checks can be defined by the enterprise itself.  
4.63.   Regarding 3.1.1.2 "Upon detection of any non -electrical failure condition (e.g. sensor 
misalignment), the warning signal as defined in point 3.1.1 shall b e activated ", the "Non-electrical 
failure condition " is contradicted with "e.g. sensor misalignment ", since the sensor bias might be 
caused by electrical failure. Regarding 3.2.1.2 "The manual deactivation of the full ELKS shall not be 
possible with less t han two deliberate actions, e.g. press and hold on a button, or select and confirm 
on menu option. ", it specifies how to manually deactivate the system. While we suggest the 
behaviour manner of manually stopping the system should not be limited. As long as  the purpose of 
lane keeping and controlling is achieved, the specific technology should not be restricted. Regarding 
3.6.2 "In the absence of conditions leading to deactivation or suppression of the system, the CDCF 
shall be able to prevent lane departure  by crossing of visible lane markings in the scenarios shown 
in the following table by more than a DTLM of -0.3 m ", the requirement of lane departure by 0.3m 
is too high and different requirements should be provided respectively for passenger car and 
 
17 For previous statements follow the thread under ID 700 . G/TBT/M/84  
 
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  comme rcial vehicle. Based on the research conclusion of Chinese LKA system standard, the 
suggested lane departure should be 0.4m for M1 and N1 vehicles and 0.75m for vehicles of other 
categories. Besides, only relevant requirements for ELKS system in straightwa y scenarios are 
specified in the regulation. We suggest relevant ELKS requirements for curve lane should be added 
by referring to the relevant parts in Chinese LKS standards for passenger cars and commercial 
vehicles.  
4.64.   3.6.2 (a) The definition of "for latera l departure velocities in the range of the 0.2 m/s to  0.5 
m/s for vehicle speeds up 100 km/h and for lateral departure velocities in the range of 0.2 m/s to 
0.3 m/s for vehicle speeds greater than 100 km/h and up to 130 km/h (or the maximum vehicle 
speed i f it is below 130km/h) " is unreasonable since the system in the activated status should always 
keep the vehicle within the lane and do not need to differentiate other conditions. 3.6.2 (e) The 
requirement "in all illumination conditions without blinding of the sensors " is too strict. Quantitative 
requirement should be raised such as 500lx. Regarding 3.6.3.1 "The steering control effort necessary 
to override the directional control provided by the system shall not exceed 50 N. Significant loss of 
steering sup port once overridden shall not happen suddenly ", we suggest the requirements of 
steering control effort be deleted. As long as the purpose and requirements of control are achieved, 
the OEMs should be allowed to calibrate the steering torque according to th e realizing strategy. 3.6.4 
The requirements of CDCF warning guidance are too detailed. We think the warning conditions alone 
are enough, requirements could be changed to "warning signal should be given when the system 
intervention action enters and exits,  electronic or electric malfunction occurs during the system self -
check and running, and the driver actively (manually) turns off the system and that signal shall be 
acoustic, tactile or optical signal (at least one of those three aforementioned) ". 4 and 5 : only relevant 
requirements for ELKS system in straightway scenarios are specified in the regulation. We suggest 
the curve lane testing scenario be added by referring to the relevant parts in Chinese LKS standards 
for passenger car and commercial vehicle.  4.2(b) and 5.2 (b): the requirement of environment 
illumination condition, 2000lx, is too high and we suggest the number should be 500lx. Regarding 
4.2(c) and 5.2 (c) "In ambient air temperatures between 5°C and 45°C "，the environment 
temperature condition d oesn't consider low temperature and we suggest the temperature range be 
modified from 5℃~45℃ to -20℃~40℃. 
4.65.   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 7 February 2021 was 
submitted via the TBT Enquiry Point on 13 April 2021. As stated in the reply, the EU would like to 
clarify that the manufactu rer has to demonstrate to the Technical Services  that the requirements 
under the draft Regulation  are fulfilled for whole range of speed and lateral departure velocity. The 
Technical Service can request the manufacturer to provide the respective documentat ion and can 
carry out, if needed, its own tests under these different conditions. In addition, where it is recognized 
that the performance required may not be fully achieved in other conditions than those listed in 
points 3.5 and 3.6 of the draft Regulatio n (e.g. different environmental conditions), the manufacturer 
should ensure that the system does not unreasonably switch the control strategy under these other 
conditions and should demonstrate this to the satisfaction of the Technical Service. In that res pect, 
the EU also observes that if being switched off manually, the ELKS shall be switched on automatically 
upon each activation of the vehicle master control switch. The AEBS and the ESC are covered by 
other Regulations independently. For example, in acco rdance with UNECE Regulation No 152 on 
AEBS that will apply in the EU on a compulsory basis from July 2022, the AEBS shall also be 
automatically switched on at the initiation of each new ignition cycle. In addition, when the automatic 
deactivation of the A EBS function is a consequence of the driver manually switching off the ESC 
function of the vehicle, this deactivation shall require at least two deliberate actions by the driver.  
4.1.2.17   Kingdom of Saudi Arabia - Order on Standards for Import Products (ID 70118) 
4.66.   The representative of India provided the following statement. India recognizes the right of 
Saudi Arabia to regulate products it imports within the commitments of the WTO. Apart from 
conforming to Saudi Arabia's SASO (Saudi Standards), all consignments to S audi must carry the 
Certificate of Conformity. Indian Exporters are already adhering to the SASO requirements by 
obtaining certifications from accredited laboratories based on product testing. However, insisting on 
such certification even for regular consu mer products that do not endanger the health and safety of 
humans makes the trade burdensome and restrictive. Hence Saudi Arabia is requested to remove 
the SASO requirement for everyday consumer items like leather products and footwear. Article 5.1.2 
 
18 For previous statements follow the thread under ID 701 . G/TBT/M/84  
 
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  of the TBT Agreement requires that Members shall ensure that CAPs are not prepared, adopted or 
applied with a view to or with the effect of creating unnecessary obstacles to international trade. 
CAPs shall not be more strict or be applied more strictly than is necessary to give the importing 
Member adequate confidence that products conform with the applicable technical regulations or 
standards, taking account of the risks non -conformity would create. In view of the above, Saudi 
Arabia is requested to remove the CoC requirements to regular consumer products; if not, it may 
clarify the rationale for extending the requirement of SASO to regular consumer products that are 
not a threat to human life or health.  
4.67.   In response, the representative of the Kingdom of Saudi Ar abia provided the following 
statement. Saudi Arabia would like to express its appreciation on the concerns addressed by India. 
Saudi Arabia is aiming at protecting human health and safety, and the environment, by regulating 
and ensuring that such products are complying with safety requirements and relevant standards in 
consumer products. Saudi Arabia does not mandate all products to obtain a certificate of conformity 
and considers supplier's declaration of conformity as sufficient for risk -free products, ho wever, the 
Kingdom  issues technical regulations for medium and high -risk products, which requires issuing a 
certificate of conformity. As for the conformity assessment procedures, SASO has chosen to apply 
the international standard ISO/IEC 17067 for granti ng certificates of conformity to products issued 
by Notified Conformity Assessment Bodies in response to the pressing health problems posed by 
non-conforming products detected by National Surveillance Authorities. In regard to leather 
products, it contains  a number of risks to the health and safety of the consumer and the 
environment, therefore, Saudi Arabia was keen to mandate a certificate of conformity as well as 
number of requirements related to harmful substances in the technical regulation for leather  
products, and the most important of these harmful substances, which must be adhered to the 
permissible limits of the relevant standards, are: Chromium (VI); Formaldehyde; Chlorinated 
phenols.  
4.1.2.18   United Arab Emirates - Requirement of G -mark for every toy (ID 70219) 
4.68.   The representative of India provided the following statement. India is deeply concerned about 
the UAE's G -mark requirement for all children's toys exported to the UAE and it can be issued only 
by the agencies authorised by the GCC Standardisation Or ganisation. This requirement of G -mark 
makes Indian products uncompetitive in the UAE as no agency is authorized to issue G -mark in 
India. To get G -mark certified products, Indian exporters have to send the entire consignment to 
the place where it can be G -mark certified. As per the extant  regulation, the G -mark needs to be 
obtained for each and every toy. This process involves additional procedural requirements; it is also 
cost-intensive and makes the Indian product uncompetitive when placed in the UAE mar ket. Further, 
the G -mark Notified Bodies (NBs) during the conformity assessment frequently request physical 
samples of all products in a group, and not only of the representative item. This is despite the latest 
GSO guidance specifying test reports are req uired only for one representative item from a product 
group. A physical inspection of all items in a product group is burdensome, costly and inconsistent 
with Article 5.1.2 of the TBT Agreement. Hence, the UAE is requested to consider that when the G -
mark is obtained for each and every toy, then the physical sampling should not be insisted by the 
NBs for all the products in the group. Such insistence is trade restrictive and renders high costs and 
difficulties. Besides, it also inconsistent with Article 5.1 .2 of the TBT Agreement.  
4.69.   In response, the representative of the United Arab Emirates  provided the following statement. 
We have already forwarded the concerns of India to the capital. We will get back to the delegation 
of India as soon as we receive a respo nse from the concerned authority.  
4.1.2.19   EU - Phosmet, G/TBT/N/EU/790  (ID 70320) 
4.70.   The representative of Chile provided the following statement. Chile appreciates the 
opportunity to comment in this Committee on the European Union's notification submitted on 25 
March 2021 to the WTO Committee on Technical Barriers to Trade in document G/TBT/N/EU/790 , 
which concerns the non -renewal of the approval of the pesticide active substa nce phosmet under 
Regulation (EU) No.  1107/2009, as well as on the measures that shall likely be notified to the WTO 
Committee on Sanitary and Phytosanitary Measures relating to the reduction or definitive elimination 
of the maximum residue levels (MRLs) f or this substance in food.  The Chilean Fruit Exporters 
 
19 For previous statements follow the thread under ID 702 . 
20 For previous statements follow the thread under ID 703 . G/TBT/M/84  
 
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  Association is a non -profit, private trade association, the various programmes of which bring 
together over 350 fresh fruit producer -exporter companies, accounting for around 90% of Chile's 
fresh fruit  exports and 63.1% of the area under fruit cultivation nationally.  In such activities, 
phosmet has for many years been an irreplaceable tool for implementing plant protection 
programmes and strategies to control a broad spectrum of pests of productive sign ificance, such as, 
inter alia , Lobesia botrana , Pseudococcus  spp. and Drosophila suzukii . Furthermore, phosmet  
possesses a range of technical characteristics that are associated with strong levels of pest control 
and crop protection periods, convenient withholding or safety periods, large tolerances and a very 
good cost/benefit ratio.  A reduction in European Union  countries of the current MRLs for phosmet in 
various fruits would cause a serious problem for our producers and exporting companies, since there 
are no alternatives possessing all the strengths described above for this insecticide.  
4.71.   We have received inform ation from the firm Gowan Company, which is a manufacturer of this 
product. The firm submitted a range of data from the record in January 2016 as part of the European 
Union's active substance renewal process (AIR), with the intention of securing the renewa l of the 
inclusion of this insecticide in Annex I to Directive 91/414/EEC.  The rapporteur member State, Spain, 
submitted an assessment report in December 2017 containing a recommendation for the renewal of 
this substance in Annex I. The European Food Safet y Authority's (EFSA) peer -review experts 
meetings in June 2019 and February 2020 concluded that there are no effective substitutes for 
phosmet, that it is not persistent in the environment and that it does not cause endocrine disruption 
problems.  However, the EFSA decided to lower by between ten and twenty times the thresholds for 
assessing both the effects of the substance in mammals and its ecotoxicological effects, meaning 
that the toxicity and ecotoxicological aspects of the molecule would not have been  appropriately 
reviewed.  Chile considers that the elimination of MRLs, rather than their reasonable reduction, will 
lead to serious problems for domestic and international fruit -farming, encouraging the use of less 
effective products that will result in sm aller yields and, consequently, in an increased use of 
substitute products, which subsequently runs the major risk of the permitted levels being exceeded, 
among other considerations.  In summary, we ask the European Commission to take into account 
the above  considerations in order to ensure an appropriate assessment of the MRLs for phosmet in 
the products and by -products that our country and others export to this economic area.  
4.72.   The representative of Brazil  provided the following statement. Brazil would like to support the 
STC raised by Chile against the European Union regarding the Draft Commission Implementing 
Regulation concerning the non -renewal of approval of the active substance phosmet, notified as 
G/TBT/N/EU/790 . Phosmet is registered in Brazil as an active substance for insectic ide and acaricides 
used on citrus, apple and peach. It is recognized as an important crop protection tool used by 
Brazilian citrus growers to treat citrus fruit borer, fruit flies and citrus psyllid pests. Regarding the 
control of the citrus psyllid, combi ned with other several non -chemical measures, it is rather 
important since this insect transmits the greening disease, recognized by EFSA itself as a priority 
pest for control, according to the Commission Delegated Regulation (EU) 20 -19/17 -02. The non -
renewal of the approval of this active substance, coupled with the following reduction of its MRL, will 
have a significant impact on trade and will be particularly harmful towards the citrus industry in 
Brazil, where citrus is the main source of income to thou sands of farmers living in the countryside. 
The European Union is the top destination of Brazilian citrus products with over USD 1.13 billion of 
export value in the 2019 -2020 marketing year. Brazil regrets having to urge once again the European 
Union to al so notify measures related to registration of active substances to the SPS Committee. 
The EU had already committed to notifying such measures to both committees, so the fact that this 
draft regulation was notified only to the TBT Committee is seen as a wor risome setback. Brazil would 
also like to kindly ask the EU to adopt new MLRs that are in line with the limits defined by the Codex 
Alimentarius.  
4.73.   In response, the representative of the European Union  provided the following statement. The 
European Union con firms that it has received comments from the Chilean Fruit Exporters Association 
(Asociación de Exportadores de Frutas de Chile A.G., Asoex) that were forwarded by the Ministry of 
Foreign Affairs. The European Union is currently preparing an official reply  to those comments. At 
this stage, we can inform you that the Commission has proposed not to renew the approval of 
phosmet. Following a comprehensive and transparent assessment of the information submitted by 
the applicants by the designated rapporteur mem ber State, and after being peer -reviewed by all 
other member States and the European Food Safety Authority (EFSA), serious risks and concerns in 
relation to human health and the environment have been identified. It is therefore considered that 
the applican ts have not demonstrated that plant protection products containing phosmet can be 
used safely.  G/TBT/M/84  
 
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  4.1.3   Previously raised concerns  
4.1.3.1   China - Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administrat ion (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29421) 
4.74.   The representative of the European Union  provided the following statement. Regarding the 
Multi-Level Protection Scheme, the EU would like to refer to its 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 subseque nt 
unwarranted and significant market entry 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 a llow for adequate participation of interested 
parties.  
4.75.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding the China's "Regulation on the Administration of Commercial Cipher Codes " and 
"Cyber Security Mu lti-Level Protection Scheme. " Japan would like to refer to the previous statement 
we made at the last TBT Committee in February 2021. At the last TBT Committee, China explained 
that they would release the regulations for public consultation. We recognize t hat the public 
consultation had done until 19 September 2020. Japan would like to request that China provide 
relevant information regarding the current revision process and that the regulations would be 
implemented transparently.  
4.76.   In response, the represent ative of China  provided the following statement. With regard to the 
management of commercial encryption products, China has, from 1 January 2020, cancelled the 
approval of varieties and models of commercial encryption products in accordance with the law, a nd 
established a unified national certification scheme for commercial cryptography. The management 
of commercial encryption products fully reflects the principles of non -discrimination and fair 
competition. It treats domestic and foreign products as well a s companies equally. China implements 
mandatory testing and certification on commercial encryption products which is related to national 
security, national economy, people's livelihood, and public interest, and implements voluntary 
testing and certificatio n on other commercial encryption products. Regarding the MLPS, with 
technology development, in response to more complicated cybersecurity circumstances, information 
security multi -level protection scheme needs to be improved. Based on experience in past ye ars and 
responding to new development, Cybersecurity Law stipulates that China will carry out the 
cybersecurity MLPS, which is based on information security MLPS. To fulfill the requirements in 
Cybersecurity Law, regulation on cybersecurity MLPS is under d rafting, which was published for 
comments in June 2018 and will replace the former administrative measures on information security 
MLPS.  
4.1.3.2   European Union - Hazard -based approach to plant protection products and setting 
of import tolerances (ID 39322) 
4.77.   The rep resentative of Costa Rica  provided the following statement. As on previous occasions, 
Costa Rica reiterates its support for the trade concern raised by Australia.  Costa Rica is concerned 
about the 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 to support the measure. Costa Rica 
reiterates its request to t he 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.  
4.78.   The representative of Australia  provided the following statement. Australia would like to thank 
the EU for clarifying that requests for import tolerances for substances not authorized within the EU 
will be conducted in line with risk assessment principles o n a case -by-case basis and for hosting 
seminars with stakeholders providing details on related policy changes currently being considered 
by the European Commission. Australia notes that the EU is considering taking into account 
 
21 For previous stateme nts follow the thread under ID 294 . 
22 For previous statements follow the thread under ID 393 . G/TBT/M/84  
 
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  environmental effects when a ssessing requests for import tolerances for active substances no longer 
approved in the EU. Australia rejects this approach as it assumes the EU is better placed to assess 
the environmental impacts of active substances in third countries than the chemical regulators of 
those countries. Australia has a robust regulatory framework for agricultural and veterinary 
chemicals providing Australian farmers with safe access to the pesticides they need to maintain 
productivity and profitability while looking after Au stralia's unique environment. Australia requests 
that the EU respects the conclusions of trading partners' regulators on the environmental impact of 
chemical substances and limits its assessment of requests for import tolerances to the consideration 
of die tary risks. Departing from this approach will result in significant trade disruption. We remain 
available to discuss our approach to pesticide regulation with the EU and look forward to continued 
constructive engagement on this issue.  
4.79.   The representative of  Colombia  provided the following statement. Colombia once again shares 
this concern regarding the approach taken by the EU for identifying plant protection substances.  As 
we have stated in various fora of this Committee, we reiterate the need to use risk a nalysis as a 
methodological 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 phytosanitary 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 eviden ce, production processes and methods, the international recommendations of the 
Codex Alimentarius, and the relevant ecological and environmental conditions in countries that may 
be affected by the implementation of the measure, in order to avoid creating a n unnecessary 
technical barrier to trade.  
4.80.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and refers to its statement made at the previous meeting. Paraguay stresses 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. While 
the European Union has noted the concerns expressed by a number of Members, we hope that it 
takes into consideration the relevant information on pesticides provided by specialized agencies 
recognized by the WTO, such as the Codex Alimentarius; reconsiders its approach; bases its 
decisions on conclusive scientific evidence and real ri sk weights, in accordance with the relevant 
international principles and standards; ensures import tolerances and, where necessary, provides 
adequate transitional periods.  
4.81.   The representative of Brazil  provided the following statement. Brazil would like to refer to its 
previous statements regarding STC 393. 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 sepa rate chemicals that have the potential to 
cause harm due to their endocrine mode of action from those substances that do not pose a threat 
to human health. A solid risk analysis, consistent with Codex guidelines, is important to ensure 
transparency and pre dictability in the regulatory processes regarding plant protection products and 
LMRs. Brazil believes that the European approach to limit the use of pesticides is more trade -
restrictive than necessary to fulfill its legitimate objectives under the TBT Agre ement. It also 
disregards risk analyses in the setting of regulatory measures that may have a serious impact on 
trade.  
4.82.   The representative of Canada  provided the following statement. Canada would like to take 
this opportunity to once again echo the concerns  raised by many other Members regarding the EU's 
hazard -based regulation for active substances in plant protection products. Canada does not favour 
or promote the use of any one production method over another. Instead, we support producers 
having access to  the widest choice of safe production methods based on their own assessment of 
growing conditions, market demand and other factors. Plant protection products are registered for 
use in Canada only after rigorous scientific evaluations confirm that they do n ot pose unacceptable 
risks and have value. As such, these products have a role in supporting a variety of production 
methods and enable the sector to supply the vast array of differing products demanded by Canadian 
and international consumers. We encourage  the EU not to limit or discourage the use of these 
agricultural tools, and base its regulatory decision -making on both hazard and risk for all active 
substances.  G/TBT/M/84  
 
- 24 - 
 
  4.83.   The clarifications provided by the EU regarding the process for establishing import toleranc es, 
particularly for active substances that are not re -authorized due to the hazard -based criteria or that 
are no longer supported by the applicant, have been welcome. Canada also notes the EU's intents 
to conduct risk assessments for all import tolerance requests, including those for active substances 
that meet the EU's hazard -based criteria, in accordance with internationally -accepted risk 
assessment principles and EU legislation. To eliminate the need for import tolerance requests for 
some substances and  minimize disruptions to trade, Canada once again requests that the EU 
consider maintaining MRLs for substances that do not pose unacceptable dietary risks. We recognize 
that a dietary risk assessment as part of the re -authorization process would likely be  needed, 
regardless of the results of the hazard screen. We welcome further engagement with the EU on this 
issue. We also invite the EU to share any relevant information on upcoming regulatory or policy 
changes to ensure that unnecessary trade barriers are  minimized and that measures are consistent 
with international trade obligations.  
4.84.   The representative of Guatemala  provided the following statement . 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 are assessed and there is growing scientific 
uncertainty.  We would like to emphasize the importan ce of using risk analysis for import tolerances, 
particularly for tropical developing countries, where climatic conditions differ from those in the EU 
because we do not have a harsh winter to help control pests.  In addition, geographical location, 
namely t he distance and time needed to export a product to the EU, is another factor that should be 
taken into consideration to avoid applying measures that unnecessarily restrict trade.  
4.85.   The representative of Uruguay  provided the following statement. We support th e comments 
made by the preceding Members and reiterate our trade and systemic concern relating to the 
European Union's use of a hazard -based approach, instead of an approach based on full scientific 
risk assessments, when making regulatory decisions concer ning 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 Regulation No. 1107/2009.  We again emphasize the need to base 
such determinations on con clusive scientific evidence, gathered 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 than on actual risk could have a negative and disproportionate 
impact on sustainable agricultural production, food security and international trade in food products, 
while contributing little or nothing to the cited aim of pro tecting public health.  Like other Members, 
we would like to be given further details on the way in which the European Union plans to take 
environmental effects into account when assessing requests for import tolerances for active 
substances no longer appro ved in its territory.  Uruguay continues to support any multilateral 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 th e 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 trad e in agricultural products and the serious socio -economic 
consequences that this may have for other Members, in particular developing and least developed 
countries, for which the European  Union is a key market.  
4.86.   The representative of Chile provided the foll owing statement. Chile is grateful for the 
opportunity to reiterate to the European Union the concern regarding the bloc's Regulation, as raised 
by the delegations that took the floor before me. These measures will have far -reaching trade effects 
for Chile 's export sector.  
4.87.   The representative of Ecuador  provided the following statement. Ecuador shares the concerns 
raised in the statements made by the Members who have 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 with international risk -assessment practices.  Ecuador urges the EU to take 
into account s cientific information emanating from the international 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 Committ ee on Technical Barriers 
to Trade related to good regulatory practices, particularly with regard to carrying out a Regulatory 
Impact Analysis prior to the issuance of regulatory proposals, which examines all possible social, G/TBT/M/84  
 
- 25 - 
 
  economic, environmental and hea lth impacts. This is to ensure compliance with the obligation not 
to be more trade -restrictive than necessary to fulfil a legitimate objective, in accordance with 
Article  2.2 of the TBT Agreement.  Lastly, my country once again calls upon the EU to ensure t hat, 
in cases where there is a lack of scientific information, EFSA does not make a recommendation on 
the MRL, since decisions on regulatory measures must be based on conclusive risk analyses that 
provide real health protection and do not constitute a tech nical barrier to trade.  
4.88.   In response, the representative of the European Union  provided the following statement. The 
European Union 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 endo crine 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 definit ion of scientific 
criteria to identify endocrine disruptors 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 Europea n Union decided to follow the procedures of Regulation (EC) No 
396/2005 for the management of import tolerance requests concerning active substances falling 
under these cut -off criteria, which include a risk assessment by an evaluating EU member State and 
a scientific opinion by the European Food Safety Authority (EFSA). The granting of the import 
tolerance 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 com mitment to act in full transparency and 
keep Members duly informed about further developments.  
4.1.3.3   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53323) 
4.89.   The representat ive of the European Union  provided the following statement. The EU has raised 
the Security Review of Network Products and Services, including the Cybersecurity Review Measures, 
in this Committee on several occasions, stressing our concerns related to these  measures, which 
entered into force on 1 June 2020. We remain concerned that the measures are quite general and 
very broad discretionary powers are left to the authorities in charge of the security review, raising 
concerns for foreign ICT operators. The me asures are directed towards the purchasing activity of 
Critical Information Infrastructure (CII) operators by encouraging operators to apply for reviews in 
the case that they deem their purchase or procurement may pose a risk to Chinese national security. 
Most European companies established in China would become suppliers or sub -suppliers of these 
operators, and therefore would also be affected by the reviews. The EU urges China to ensure clarity, 
transparency and objectiveness in the security review so tha t the measure does not become a new 
market access barrier. The EU also seeks an update of this measure from China.  
4.90.   The representative of Japan  provided the following statement. Japan has its interest in and 
concern with regard to the Cyber Security Review and would like to refer to the previous statement 
we made at the last TBT committee in February 2021. At the last TBT committee, China explained 
that Cybersecurity Review of Network Products and Services is not to restrict nor discriminate against 
foreign products and services, and China welcomes foreign products and services to enter Chinese 
market. Japan would like to request that China provide relevant information regarding the current 
revision process and that the regulations would be implemented transp arently.  
4.91.   The representative of Canada  provided the following statement.  Canada echoes the concerns 
raised by the EU and Japan. With respect to this STC, Canada continues to seek defined criteria that 
operators of Critical Information Infrastructure are to  use in assessing a security threat; and a clear 
commitment to National Treatment, MFN treatment and the use of international standards. Canada 
appreciated the recent opportunity to provide comments on the 2nd draft of China's Data Security 
Law, as follows : The law sets requirements for entities processing "important data" and transferring 
it across borders. With a view to better understanding the legitimate objectives of the Law and the 
risks of non -fulfillment, Canada requests that China clarify the meani ng of "important data"; Canada 
also seeks China's clarification of how the inclusion of language on reciprocal Chinese actions, to 
address other countries' discriminatory actions, is consistent with the TBT Agreement's obligations. 
In order to provide clar ity and predictability, we also reiterate our request for a clear definition of 
"Critical Information Infrastructure", which is referenced in both the draft cybersecurity measure 
 
23 For previous statements follow the thread under ID 533 . G/TBT/M/84  
 
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  and the draft Data Security Law. Canada looks forward to receiving China's fe edback on the Data 
Security Law and seeks China's agreement to notify it to the TBT Committee.  
4.92.   In response, the representative of China  provided the following statement. In April 2020, CAC 
and 12 other authorities jointly issued Cyber Security Review Measu res. Focusing on national 
security risks associated with the procurement of network products and services by critical 
information infrastructure operators. Through the cybersecurity  review, the risks and hazards 
brought by the purchase of products and serv ices to the operation of critical information 
infrastructure could be found earlier and avoided, ensuring the security of the supply chain of critical 
information and infrastructure, and safeguarding national security. The Measures came into effect 
on 1 Ju ne 2020, and the former Cybersecurity Review of Network Products and Services (for Trial 
Implementation) issued in May 2017 was repealed at the same time.  
4.1.3.4   Russian Federation - Law No. 425 - on Amending Article 4 of Russian Federation 
Law "On Protecting Con sumer Rights" (ID 61224) 
4.93.   The representative of the United States  provided the following statement.  We continue to 
raise our concerns about the recently adopted amendment to Russia's "Law on Protection of 
Consumer Rights, " which requires pre -installation o f Russian software on "technically complex 
goods " (TCGs) sold in Russia. Our understanding is that the implementation deadline was 1 April 
2021. Despite the passing of this deadline we remain unclear on the status of the final implementing 
guidance for the  amendment and whether the measure has been revised in response to our 
concerns. We presented our concerns to Russia in writing in March 2020 and raised them again 
during each subsequent meeting of the TBT Committee, but Russia has not yet provided an adeq uate 
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 ap plicable administrative provisions, with 
which compliance is mandatory ". The measure mandates product characteristics and production 
methods for technically complex goods sold in Russia – namely that these devices must contain 
certain software which must b e pre -installed. Law No. 425 -FZ therefore appears to meet the 
definition of a technical regulation.  
4.94.   It remains unclear what legitimate objective Russia is trying to achieve with these 
requirements. An Explanatory Note issued by Russia's Federal Antimonopol y Service (FAS) stated 
the need to ensure non -discriminatory access of Russian software developers to electronic devices. 
Many of the technically complex goods targeted by this technical regulation already feature software 
from Russian developers and inclu de app platforms which encourage participation by Russian 
companies. We ask Russia to explain why they believe Russian software developers are being denied 
access to these electronic devices, and why such a requirement is necessary. We also ask Russia to 
explain how the requirement is not more trade restrictive than necessary and does not create 
unnecessary obstacles to trade. We have urged Russia to notify these implementing regulations to 
the TBT Committee, to allow reasonable time for stakeholders to mak e 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. With the passing 
of the implementation deadline, we remind Russia of these requests and also urge Russia to notify 
the implementing rules as soon as they are available.  
4.95.   The representative of the European Union  provided the following statement. The European 
Union has concerns on amending article 4 of the Russian Fe deration 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 it s WTO transparency obligations and notify the measure to the TBT 
Committee. We are also looking forward to receive the answers to the questions raised by the US 
delegation.  
4.96.   The representative of Japan  provided the following statement. Japan would like to s hare 
concerns regarding this measure expressed by the US. This proposed measure includes unclear 
articles regarding definitions of terms, concrete requirements for review and evaluation, and the 
scope of regulations including covered software list. Japan's  concern is that the measures may 
hamper market access for foreign companies in Russia, depending on the concrete details of rules 
 
24 For previous statements follow the thread under ID 612 . G/TBT/M/84  
 
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  governing its implementation. Therefore, Japan would like to ask Russia to implement this measure 
in a non -discriminatory man ner and not to make it more trade -restrictive than necessary in line with 
the TBT Agreement. Japan would like to request that Russia notify this measure and the relevant 
regulations to the TBT committee to ensure transparency of the procedure.  
4.97.   The represen tative of Canada  provided the following statement. Canada supports the 
statements made by the United States, Japan and the European Union.  
4.98.   In response, the representative of the Russian Federation  provided the following statement.  
We appreciate interest o f the US and other delegations in the Russian Federation's regulatory policy. 
As stated previously on numerous occasions, Russia maintains its position that the measure in 
question does not fall under the scope of the Agreement on Technical Barriers to Tra de and cannot 
be considered as a technical regulation. The amendments to the Federal Law "On Consumer Rights 
Protection " do not set requirements for product characteristics or production methods. Thus, 
requirement on pre -installation of certain Russian sof tware products on technically complex products 
does not correspond to the definition of technical regulation set forth in Annex I to the Agreement 
on Technical Barriers to Trade. Moreover, the measure in question cannot be considered as 
discriminative sinc e it does not mandate replacement or de -installation of the foreign software 
programs. Russia is open to bilateral discussions.  
4.1.3.5   Colombia - Food Prioritized for its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238,  G/TBT/N/COL/238/Add.1  (ID 60925) 
4.99.   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 range of foods, such as tuna, chicken sausages, chorizo, 
salted  biscuits, ham, peanuts, butter, mayonnaise, breads, pastas, wheat flour products, cream 
cheese, soups, sauces and sausages.  Costa Rica firmly believes in implementing strategies aimed at 
protecting 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 established for each product, so as to facilitate our analysis o f the legislation.  We 
would again 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.  
4.100.   In response, the representative of Colombia  provided the followin g statement. The following 
are some considerations and information on Colombian regulations . Resolution No.  2013 of 2020 is 
the result of a public health measure and is part of a comprehensive strategy called the National 
Strategy for the Reduction of Sodi um/Salt Consumption 2012 –2021, which covers not only sodium 
content in processed foods, but also other sources of sodium, such as the salt added to preparations 
in restaurants, at home and in institutions.  The strategy seeks to reduce mortality attributabl e to 
high blood pressure and cardiovascular disease by gradually reducing salt consumption from food 
sources until the WHO recommendation for 2021 has been achieved: 5 grams of salt or 2 grams of 
sodium per person per day.  With regard to concerns about the  technical and functional role of sodium 
in the production of prioritized foods, Colombia wishes to reiterate that this was analysed at all of 
the technical meetings for the 12 categories of food, involving industry, academic and government 
representatives , leading to an agreement and dissemination of the draft regulations.  The following 
are documents produced by the Ministry of Health and Social Welfare providing technical support for 
the measures taken through Resolution No.  2013 of 2020 on the maximum so dium content for 
processed foods . National Strategy for the Reduction of Sodium/Salt Consumption 2012 –2021.26 
Regulatory impact analysis of the draft resolution defining the maximum sodium content in 
 
25 For previous statements follow the thread under ID 609 . 
26 Available at 
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/PP/SNA/Estrategia -reduccion -sal-2012-
2021.pdf  G/TBT/M/84  
 
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  prioritized foods.27 Document explaining the methodology  for prioritization and setting targets for 
the 59 foods and summarizing the report of the regulatory impact analysis report (Annex 1).  
4.1.3.6   India - Quality Control Orders for Chemical and Petrochemical Substances, 
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/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/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/191,  G/TBT/N/IND/193,  G/TBT/N/IND/199  
(ID 63028) 
4.101.   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 , phthalic anhydride, n -butyl acrylate and terephthalic acid (notified by 
G/TBT/N/IND/69 , G/TBT/N/IND/116 , G/TBT/N/IND/123  and G/TBT/N/IND/124) . Firstly, we would 
like to thank India for postponing the enforcement date on n -butyl acrylate for another 180 days, 
which were announced on 26 April 2021. In the view of the persistent impact of COVID -19, we 
suggest  that India consider postponing the implementation of the other drafts of Chemical and 
Petrochemical Orders, at least, for another 180 days. Secondly, we have been following closely the 
above -mentioned drafts since last year. We still have the following co ncerns to seek India's 
clarifications. The reason and risk assessment of changing the current voluntary system to a 
compulsory certification system, especially for terephthalic acid. The necessity of annual "on -site" 
factory inspection. The reasonable vali dity period of licence for both domestic and foreign applicants 
on a non -discriminatory basis. Accepting conformity assessment results from testing laboratories 
and inspection bodies outside India.  
4.102.   Thirdly, since the pandemic will not likely end in the sho rt term, we understand the difficulty 
of conducting regular conformity assessment procedures under the current situation. We still suggest 
that India implement alternative measures during the pandemic, such as temporary factory audit 
exemption for a limite d period or remote factory inspection, to address the difficulties of physical 
inspection resulted from international travel restrictions. Finally, we would like to express our 
concern on the Caustic Soda Quality Control Order, which entered into force in April 2018. We respect 
the efforts of India to introduce the Order for the health and safety of Indian people. Our 
manufacturers submitted their applications and ensured compliance of their products with the 
specifications stated in IS 252. However, their applications have been pending for more than a year 
even after payment of fees and completion of testing as well as on -site factory audit. We urge India 
to accelerate procedures for granting approval of our companies. In this regard, we noted recently 
that a policy was adopted by the Department of Chemicals and Petrochemicals of India to stop 
granting BIS licences to all foreign applications for caustic soda because of the sufficient installed 
capacity in India. As this policy will also apply to foreign app lications for other chemicals, we seek 
confirmation from India on this policy and urge India to observe the principle of non -discrimination 
as stated in Article 2.1 of the TBT Agreement. We would be grateful if the above -mentioned 
comments could be taken i nto account and look forward to a written response.  
4.103.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. The EU remains concerned 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. The EU welcomes India's recent decision to  defer the 
implementation of some QCOs pertaining to chemical products by 180 days to 3 February 2022 and 
13 March 2022. However, the European Union would like to seek clarifications from India, explaining 
the reasons for establishing India -specific Qualit y Control Orders when these chemical products 
 
27 Available at:  
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/PP/SNA/analisis -impacto -normativo -sodi
o.pdf 
28 For previous statements follow the thread under ID 630 . G/TBT/M/84  
 
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  already comply with internationally recognised standards. The EU would like to remind the 
authorities of India that in accordance with the TBT Agreement, standards are considered voluntary, 
whereas mandatory st andards are considered as technical regulations. The EU would like to recall 
Article 2.2 of the TBT Agreement, according to which Members shall ensure that technical regulations 
are not prepared, adopted or applied with a view to or with the effect of crea ting unnecessary 
obstacles to international trade. The EU would like to encourage India to align the BIS standards 
with international approaches.  
4.104.   The representative of the United States  provided the following statement. As of May 2021, 
India's Ministry of Chemicals and Fertilizers (MoCF) notified 43 Quality Control Orders (QCO) to the 
WTO TBT Committee. Each QCO appears to identify substances that correspond to or fall under the 
72 identified chemicals and petrochemicals for which India intends to mandate c ompliance to 
standards set by the Bureau of Indian Standards (BIS). We also understand that on 15 April 2021, 
MoCF published final versions of 7 of the notified QCOs in the Gazette, with the measures set to 
enter into force on 15 October 2021. We appreciat e India's efforts to notify these QCOs to the WTO 
TBT Committee and to provide stakeholders with the opportunity to submit comments. Given the 
impact on trade and the difficulty in accessing the referenced standards, we kindly reiterate our 
request that fo r the 43 notified QCOs and any future QCO notifications, India provide website links 
to and/or copies of the BIS proposed standard. With respect to the previously notified QCOs, we 
would recommend that such links and/or copies be notified as addenda. Witho ut access to the BIS 
standards, interested parties will be unable to become fully acquainted with the QCOs or to provide 
meaningful comments.  
4.105.   With respect to the QCO for polyethylene material used for molding and extrusion 
(Polyethylene QCO), notified as IND/191, we note that US industry has expressed concerns 
regarding inclusion of a labelling requirement that involves the marking of individual unit packages 
of polyethylene product with a new "designation code " that includes an array of technical informat ion 
(e.g. a product's melting point, density, and destination use). US industry has indicated that these 
labelling requirements will pose challenges since many polyethylene products are used as 
intermediate inputs that undergo further transformation, there by making it difficult to identify all of 
the destination uses. The "designation code " would have limited utility to end users considering the 
numerous physical properties and applications that a category of polyethylene product might have. 
Several US industry members have recommended alternative methods to meet the Polyethylene 
QCO's manda tory labelling requirements. US industry has also noted that the Polyethylene QCO may 
disrupt Indian imports of, and access to, essential materials used by Indian health care, 
pharmaceutical, and other Indian export -critical sectors such as the automotive sector. Would India 
consider exempting polyethylene products used as intermediate inputs from the labelling 
requirements set forth in the Polyethylene QCO?  
4.106.   The representative of Canada  provided the following statement. In previous Committee 
meetings, Canad a raised concerns over the approach taken by India to make mandatory the use of 
Indian Standards on the regulation of a series of chemical substances. Canada remains of the view 
that the notification process followed by India to inform interested parties o f its "Quality Control 
Orders " (QCO) is problematic and could benefit from adjustments to improve the sharing of 
information with interested Parties. For example, the 1 -page document notified by India to explain 
its QCO could provide a link to additional b ackground information on the science and deliberations 
having led to the propose measure. The current scarcity of readily available supporting 
documentation in the notifications makes it difficult to assess and comment on the measures. At the 
February 2021  TBT Committee, India stated having carried out a review of the existing standard and 
conducted consultations with various leading manufacturers to ensure to reflect new testing 
methods. Canada would suggest that such information – when available – be adde d to the TBT 
notifications as basic background information for interested Parties seeking to understand the 
objective and rationale behind the Indian measure.  
4.107.   To further facilitate stakeholders' access to any related information on the BIS, Canada would 
also suggest that India includes an hyperlink to the latest official version of the standards in the 
notifications. India shared such a link with WTO Members at the last TBT Committee meeting. If 
interested parties and stakeholders are not provided somewhat intuitive access to the relevant 
information that led to the regulatory proposal, they can hardly provide substantive comments and 
information that could inform India's decision -making process. Canada recognizes and strongly 
supports Members' right to regu late. However, Members must ensure that such actions follow 
internationally agreed -upon rules and processes to ensure a level playing field for all interested G/TBT/M/84  
 
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  parties. It is in this view that Canada is sharing suggestions on potential adjustments to the fu ture 
Quality Control Orders notifications of India. We believe these improvements could have a genuine 
positive impact for stakeholders, and go a long way to support the transparency obligations of the 
TBT Agreement.  
4.108.   The representative of Singapore  provide d the following statement. Singapore echoes the 
concerns raised by other Members, and would like to express our concerns regarding India's Quality 
Control Orders (QCOs) on a growing number of chemical and petrochemical products. There remain 
many operation al issues, and we would like to outline a few key examples. Regarding India's QCO 
on polyethylene (PE) materials used for molding and extrusion, notified under document 
G/TBT/N/IND/191 , the labelling requirements pose challenges for industry, as they involve the 
inclusion of comple x designation codes. Specifically: PE products can have multiple physical 
properties and applications, which could result in the overcrowding of product labels, while providing 
limited utility to end users; and PE products can also involve an array of pote ntial destination uses, 
which manufacturers may not have sight of, particularly if there are intermediaries involved in the 
sales and/or production process. Given the above, it is also operationally challenging to apply the 
labelling requirement at the sma llest packaging level. Hence, we would like to request India to 
positively consider alternatives, that have been proposed by industry to meet the information 
requirements of the QCO on PE products, such that the mandatory labelling requirements are not 
too onerous and challenging for the industry to comply with.  
4.109.   Regarding India's QCOs on ethylene glycol, and styrene monomer, we understand that India 
is looking to allow virtual inspections as part of the certification process. Given the fluid COVID -19 
situat ion globally, we thank India for this facilitative approach. For the industry to better prepare, 
we would be grateful if India could direct us to the relevant resources to initiate the virtual 
inspections as soon as possible, so as to allow the industry to  proceed with the certification process, 
ahead of the impending entry -into-force of the measures. For any new additional QCOs, Singapore 
would like to request for India to provide specific website links and/or copies of the proposed BIS 
standards together with the notification to the WTO in a timely manner, so that interested parties 
can acquaint themselves with the new requirements, and provide meaningful comments to India. 
We understand India's desire to protect human health and the environment, and we re spectfully 
urge India, as per its obligations under the TBT Agreement, to give full consideration to the use of 
international standards to achieve the same legitimate objectives, and to ensure that measures 
imposed are not more trade -restrictive than neces sary, or create unnecessary obstacles to 
international trade.  
4.110.   In response, the representative of India provided the following statement. The measure is 
in line with international practices. India issuing Quality Control Order for chemicals and 
petrochemica ls of HS chapters 28 and 29 as mandatory is in line with the international practices. 
India has formulated individual standards for specific chemicals indicating discreet and separate 
numbers under the BIS Act, giving technical characteristics and testing methods. Since each 
chemical has a different BIS standard number, possesses different features and different testing 
methods, India has not preferred to file a single comprehensive mandatory notification. DCPC 
(Department of Chemicals and Petrochemicals) h as notified the draft Quality Control Orders on 
chemicals and petrochemicals under the provisions of BIS Act 2016 and Rules and Regulations 
framed thereunder, which envisages conformity assessment Scheme -1 of BIS Regulations 2018. As 
per draft QCOs, the pr oduct specified 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 expor t their 
products to India. Under the provisions of the BIS Act 2016, no person shall manufacture, import, 
distribute, sell, 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 
a requisite certificate (licence), penal provisions of the BIS Act 2016 shall be applicable. The violators 
shall be prosecuted as per the Act and punishable with a fine or with imprisonment. The require ment 
for using Standard Mark as per Scheme -1 is given in BIS (Conformity Assessment) Regulations 
2018. A copy of the same is available on the BIS website ( www.bis.gov.in ). 
4.111.   Under the provisions of Scheme -1 of BIS (Confo rmity Assessment) Regulation 2018, the 
licence can be granted for a minimum of one but up to two years and subsequently can be renewed 
for a period of a minimum of one, but up to five years. Under these provisions, BIS grants a licence 
to the manufacturer based on a successful assessment of the manufacturing infrastructure, 
production process, quality control and testing capabilities of a manufacturer through a visit to its G/TBT/M/84  
 
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  manufacturing premises. Conformity of the product to the relevant standard is also e stablished 
through third -party laboratory testing in India or testing in the manufacturing premises or a 
combination of both. Under Scheme -1 of BIS (Conformity Assessment) Regulation 2018, there is no 
provision to accept quality control assessments conduct ed by foreign firms and Labs. As per Quality 
Control Orders on chemicals and petrochemicals, every product 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 DCPC notified were reviewed by BIS, and due consideration was given to 
international standards like ISO/ASTM, wherever available. As per Article 2.2 of the TBT Agr eement, 
Members can formulate technical regulations to fulfill legitimate objectives inter alia  national security 
requirements, prevent 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 an opportunity to the Members to comment within 60 
days.  
4.112.   These standards are made mandatory to protect human health and the environment. Even 
if other countri es have not formulated TR's for such chemicals, the fact is that number of TRs of 
chemicals and petrochemicals in India are less as compared to other nations. For a long time, the 
Indian standards of chemicals and petrochemicals were voluntary in nature. T he trade of chemicals 
and petrochemicals usually occurs as per the specifications settled between the manufacturer and 
buyer irrespective of the specifications stipulated in the BIS standard, which sometimes resulted in 
dumping poor quality chemicals into India. Many chemicals are toxic and hazardous. The impurities 
such as heavy metals, cyanides, isocyanates, halides etc., enter the human and plant chain, harming 
human and animal life. Under mandatory standards regime, safe, reliable and quality chemicals are 
expected to be available. TRs for chemicals and petrochemicals have not been formulated to create 
unnecessary obstacles to international trade. The standards have been made mandatory after 
carrying a review of existing standard and following stakeholde r 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 the foreign manufacturer to penetrate and 
reach into Indian chemical market.  There would be no delay on the Indian regulator in the clearance 
of import consignments, provided the supplier satisfies the conditions stipulated in the QCO.  
4.113.   Regarding the scope of the QCOs, there is no discrimination as they apply to domestic and 
foreig n manufacturers. The BIS formulate the standards by studying all available international 
standards. Finally, standards are aligned with international standards. Presently India is in the 
process of formulating Chemicals (Management and Safety) Rules. The a spect of unnecessary animal 
testing and the element of Mutual Acceptance of Data will be looked into. As regards the links for 
the information of the QCO, the BIS standards are available at the link below.29 
4.1.3.7   Bangladesh - Hazardous Waste (E -waste) Managemen t Rules, 2019, 
G/TBT/N/BGD/3 , G/TBT/N/BGD/3/Ad d.1 (ID 62030) 
4.114.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of Bangladesh to introduce waste management rules to protect the environment and 
facilitate resource recycling. Furthermore, Korean comp anies are fully committed to complying with 
the regulations of Bangladesh. However, Korean companies have raised concerns regarding the 
Electronic Waste Management Rules. And because Bangladesh has not yet sent a letter of reply 
regarding the date of enfor cement and the restricted chemicals designated in Schedule -3, Korea 
would like to reiterate the following comments already stated at the 24 -26 February 2021 TBT 
Committee Meetings. Firstly, no specific enforcement date has been provided for these proposed 
rules. Although the schedule had been stipulated as within 2020, complying with these rules may be 
difficult if they suddenly enter into force without any prior notice. Therefore, Korea requests 
Bangladesh to provide an interval of more than six months bet ween the publication of regulations 
and their entry into force. Korea would also like to ask Bangladesh to provide a specific schedule of 
enforcement if there is one. Secondly, in Schedule -3, nine chemicals such as Polyvinyl Chloride, 
Liquid Crystals, etc,  are designated as hazardous substances. These nine chemicals are 
internationally unrestricted and virtually irreplaceable. Korea requests Bangladesh to consider 
retracting them from Schedule -3 as the designations deviate from the international practices. If not, 
Korea requests Bangladesh to kindly provide scientific evidence for limiting the use of them. Thirdly, 
 
29 https://standardsbis.bsbedge.com/   
30 For previous statements follow the thread under ID 620 . G/TBT/M/84  
 
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  for compounds of certain hazardous substances designated in Schedule -3, the standards of threshold 
limits are not clear. Korea requests Banglades h to clarify whether the standard of threshold limit is 
applied to the respective amount or to the total amount of the individual substances within a 
compound. We would be grateful if Bangladesh provides quick answers to our concerns.  
4.115.   The representative of  the United States  provided the following statement.  The United States 
again acknowledges that Bangladesh notified the Hazardous Waste (E -waste) Management Rules, 
2019, including a summary, excerpted translation of two clauses, and a threshold limits sche dule 
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 f ull text of the measure to the WTO 
TBT Committee, provide a public comment period of at least 60 days, and take such comments into 
account before finalizing the measure. Can Bangladesh provide an update on the implementation 
status of the draft e -waste rul es? The United States is concerned that by restricting 15 substances 
and broad categories of substances, the draft rules may disrupt or prevent the sale of many 
important electrical and electronic goods in Bangladesh, including certain medical devices, liq uid 
crystals for liquid crystal displays, and PVC parts for washing machines. Given the broad definition 
of some of the restricted categories, such as "copper beryllium alloys, " the draft rules may disrupt 
the supply of cellular telephones.  
4.116.   The draft rules  also appear to lack provisions for the use of certain restricted substances 
where there are no substitutes, such as lead shielding for X -ray equipment. Additionally, the 
proposed rules appear to ban the import of used or refurbished electrical and electro nic equipment. 
The proposed rules do not indicate whether industry will be able to import refurbished and repaired 
electrical and 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 Min istry 
of Health and Family Welfare and the Ministry of Commerce, to ensure that the rules accomplish the 
intended regulatory objectives without creating unnecessary obstacles to trade?  
4.117.   The representative of Canada  provided the following statement. In its i nitial comments 
submitted to Bangladesh's Enquiry Point on 16 April 2020, Canada requested that Bangladesh share 
the full regulatory text of the Management Rules with WTO Members. While Canada trusts that 
Bangladesh is currently giving due consideration to  Canada's comments, we nevertheless use this 
opportunity to again highlight some of our questions and concerns regarding the Management Rules. 
Canadian stakeholders have voiced various concerns regarding the lack of clarity of the proposed 
Management Rules  and have requested that Bangladesh provide additional supportive 
documentation on the new measure. Additional explanations would be beneficial on the scope of the 
measure, the selection criteria for the substances identified as "hazardous ", and the ration ale behind 
the determination of the threshold limits for each of them. Canada has further requested that 
Bangladesh clarify specific aspects of the Management Rules, notably regarding the method and 
rationale Bangladesh has followed to elaborate the groupi ng in Schedule -3. Some of these groups 
contain a broad range of substances, each with their own level of risks and hazard profiles. Some of 
these may not require to be grouped under the same threshold limit, or be included in Schedule -3 
altogether. This in cludes, for example, the broad group of "Mineral Wool " or the joint entry for "Nickel 
and Cadmium/Cadmium oxide/ Cadmium Sulphide ". 
4.118.   We also understand that some substances serve a specific purpose in the design of electronic 
products, like the flame retard ant Tetrabromobisphenol -A, and would like to understand better the 
rationale for their inclusion in Schedule -3. Canada would also appreciate additional information on 
how Bangladesh will be approaching enforcement of the Management Rules. Furthermore, Cana da 
would strongly encourage Bangladesh to give due consideration to any additional inputs or scientific 
evidence provided by stakeholders to ensure that the Management Rules are not more trade 
restrictive than necessary to meet its objectives, specifically  with regards to the categories and 
threshold limits of Schedule -3. This would help ensure that the new measure does not generate 
unnecessary complexity and uncertainty in global trade. Canada thanks Bangladesh for its 
engagement on this STC, and we look f orward to reviewing the full text of the Management Rules. 
Canada would appreciate if Bangladesh could provide Members with a notional timeline on when the 
full text of the Management Rules, along with its supportive documentation, will be shared with 
interested Parties.  G/TBT/M/84  
 
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  4.119.   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 wr itten 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. Th e EU would be grateful if the above -mentioned comments could be taken into account 
and replied to before adoption of the notified draft.  
4.120.   In response, the representative of Bangladesh  provided the following statement. Bangladesh 
thanks the Republic of Korea , the US, Canada, Russia, Japan, India and others for their interest in 
Hazardous Waste (E -waste) Management Rules, 2019. Most of the concerns raised by different WTO 
members have been addressed and hopefully responses will be notified in due course .31 
4.1.3.8   China - Commercial Cryptography Administrative Regulations (ID 64432) 
4.121.   The representative of the European Union  provided the following statement. The EU is 
concerned about this partial implementation measure of the Cryptography Law, and sent comments 
to the  State Cryptography Administration of the People's Republic of China (SCA) last September. 
Specifically, concerns relate to (i) the scope of the law; (ii) the lack of clarity of concepts & precision 
of procedures; (iii) the protection of intellectual prope rty; (iv) the imposition of pre -market & export 
controls; (v) the requirements around testing & certification; (vi) the imposition of additional 
"national security reviews"; and (vii) the use of domestic standards, along with the lack of 
meaningful access to pertinent Chinese standards development organizations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in order to ensure that 
legal and regulatory requirements are 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 China to notify the draft 
regulations to the WTO.  
4.122.   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 20 August 2020 and we submitted comments to China 
in September 2020. The United States is concerned that this draft measure would impose potentially 
far-reaching, highly trade -restrictive cryptography -related constraints on foreign ICT products. Does 
China intend to notify this measure to the TBT Committee and allow f or 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 encryption in 
commercial ICT applications. We understand that Chi na 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 pri or to implementation. The draft measure would establish a licensing scheme for all 
imports and exports of commercial cryptography in instances where "social and public interests " are 
concerned. Can China explain how it plans to implement this scheme in lin e with its national 
treatment commitments? What steps is China taking to ensure the scheme will be not operated as 
an unnecessary obstacle to trade?  
4.123.   Given China's TBT obligations in Article 5, what steps is China taking to ensure its 
cryptography accredita tion, 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 favourable than those accorded to domestic products? Although th e draft measure 
ostensibly encourages participation in "the development of international standards for commercial 
cryptography ", Articles 10 to 12 appear to mandate compliance with Chinese standards, which may 
diverge from international standards. In addit ion, 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 participants. In the United States' view, China should 
adopt and us e relevant international standards and harmonize its practices with relevant 
 
31 Document G/TBT/W/759  was subsequently circulated.  
32 For previous statements follow the thread under ID 644 . G/TBT/M/84  
 
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  international best practices. We would appreciate any update you can provide today on the status 
of the draft measure, and how China intends to consider the public comments it rec eived.  
4.124.   The representative of Canada  provided the following statement. In September 2020, Canada 
provided China with written comments on a draft of the regulation by China's State Cryptography 
Administration and continues to look forward to a response. At t he last TBT Committee in February, 
China indicated that the revision of the Regulation is still being researched and will be open for public 
comments in due course.33 Could China please indicate when the regulation will be opened for public 
comments again and if China plans to notify the measure to the WTO TBT Committee? As we noted 
in previous meetings of the Committee, Canada would appreciate China's consideration of modifying 
the regulations to provide further clarity, transparency and predictability by:  (i) defining what 
products involving "national economy", "people's livelihood" and "the public interest" are; 
(ii) clarifying that international standards will be the basis for China's technical regulations regarding 
commercial cryptography; (iii) support ing the creation of equitable standards by indicating that all 
stakeholders can participate in the creation of commercial cryptography standards; and (iv) 
indicating whether core and ordinary cryptography (as defined in China's Cryptography Law) will, 
along with commercial cryptography, also be subject to new regulations. Canada would also like to 
reiterate its ongoing concerns with China's Cryptography Law and requests that China: (i) define the 
scope of application in a way that ensures only legitimate ob jectives 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.  
4.125.   In response, the representative of China  provid ed the following statement. In order to 
implement the requirements of the State  to promote administration in accordance with the law, and 
to deepen the reform of "streamline administration and delegate powers" in the field of commercial 
cryptography, China  is revising the Regulations on the Administration of Commercial Cryptography 
in accordance with the legislative spirit of the Law on Cryptography. The revision of the Regulations 
follows the law -based, democratic and scientific principles. And it will be open, transparent, and on 
a scientific basis. China will solicit opinions widely and ensure that stakeholders participate in 
legislative activities through legal means. Now, the revision is still under study. We will solicit public 
opinions when it is appr opriate.  
4.1.3.9   India - Indian standards and import restrictions in the automotive sector (Quality 
Control Orders): wheel rims, safety glass, helmets, G/TBT/N/IND/118,  
G/TBT/N/IND/147,  G/TBT/N/IND/167  (ID 64934) 
4.126.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its previous stateme nts on this issue. India has adopted a number of measures in the 
automotive sector that raise important concerns across the EU industry. The EU would like to 
underline that the measures in question have protectionist orientation and are sending worrying 
signals to EU industry, EU investors, and EU member States. Once these measures come into force, 
they will cause extra burden and economic cost to the EU industry that will have to undergo 
cumbersome procedures to obtain necessary permissions and/or licences . Furthermore, the 
implementation of the QCOs for foreign companies who have their production facilities located 
outside India is impossible in the context of travel restrictions due to the ongoing pandemic. In this 
context, the European Union appreciates the decision to postpone the introduction of the mandatory 
Indian Standards Institution (ISI) marking for automotive Safety Glasses to 1 April 2022. According 
to the new Quality Control Order, as of April 2022, the automotive glass not mounted in vehicles 
(loose or spare parts) sold in India will have to obtain a new national licence and marking.  
4.127.   Although the postponed entry into force by a year to 1 April 2022 should be sufficient for 
the industry to comply with this new requirement as the industry has so far made the necessary 
applications, the current conditions in India and elsewhere, due to COVID -19 pandemic, do not allow 
for the implementation of this QCO. Its entry into force as planned would result in production lines 
coming to a standstill due to th e lack of supply of safety glass compliant with Indian QCO. We are 
hopeful that the overall health situation in India will not further affect the industry preparations for 
the new certification system. Should this be the case, we would suggest that India c onsiders further 
postponement of the entry into force of this new requirement, with a view to ensuring the continuity 
of imports of safety glass into India. Besides safety glass, EU companies are also facing concerns 
 
33 G/TBT/M/83 , para. 2.103.  
34 For previous statements follow the thread under ID 649 . G/TBT/M/84  
 
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  related to other QCOs in the automotive  sector. The draft Quality Control Order (QCO) for wheel 
rims 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 is the ISI mark. The QCO therefore will generate important 
additional costs for European automotive manufacturers while the qualitative reasons for the 
introduction of such a measure are not evident. The EU welcomes recent decision to defer the 
implementation of the Automotive Wheel Rim Component (Quality Control) Order 2020 to 21 March 
2022. Like the safety glass QCO, this Qua lity Control Order mandates an in -person audit by auditors 
from BIS on the basis of cumbersome application process requiring local presence. The EU companies 
have complied with this requirement and made the necessary applications. However, the prohibition 
to travel from and to India due to the COVID -19 restrictions continue to make physical audits difficult 
to envisage in the foreseeable future. EU companies require a timeline of 4 months from the 
completion of the audit to ensure the certified product on t he factory floor.  
4.128.   The EU therefore asks India to reconsider the introduction of this QCO. The EU would like to 
suggest as a minimum a meaningful delay of the entry into force of this measure that takes into 
account the gravity of the pandemic and the impli cations on international travel and financial 
vulnerabilities of businesses. This would allow the EU companies to meet the new requirements and 
to continue supplying customers in India. The EU would also like to urge India to consider virtual 
audits or aud its performed by recognized third -party certification experts in the location of the 
manufacturing plants. Furthermore, the EU would like to recall its suggestion to keep the BIS 
marking as optional for components, which are already in compliance with the current marking 
requirements. 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. However, the 
EU would like to request India to keep the BIS  marking as optional for components, which are type 
approved according to UN Regulation 22 concerning the approval of protective helmets and of their 
visors for drivers and passengers of motor cycles and mopeds. The European Union finds these 
measures to b e disproportionate and causing obstacles to international 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.  
4.129.   The repre sentative of Indonesia  provided the following statement. Indonesia thanks and 
supports the European Union for raising concern on Indian Standards and Import Restrictions in the 
Automotive Sector (Quality Control) Order. Indonesia thanks India for notifying  the draft of 
Automobile Wheel Rims (Quality Control), Order 2020 on 25 May 2020 to WTO Members through  
G/TBT/N/IND/147 . Under these measures, wheel rims product shall conform to the IS 16192 and 
shall bear India Standard Marking under the licence form the Bureau of Indian Standard  (BIS). 
Indonesia also appreciates India for the discussion in the virtual bilateral meeting on February. 
However, Indonesia is yet to receive substantive responses from India on our concern. According to 
the notification, this order shall come into force with effect from 1 October 2020, yet India has not 
made any addendum to the notification regarding the stipulation of the regulation. Indonesia seeks 
clarification regarding the status of the implementation of the regulation. Indonesia is of the view 
that the regulation has impacted and become trade barrier for the exporters as there are no clarity 
regarding the mechanism of the regulation. Therefore, Indonesia requests India to postpone or 
provide sufficient transition time to allow industries to comply wi th the regulation.  
4.130.   Indonesia remains concerned that the conformity assessment procedure as required in the 
document is more restrictive than necessary. The procedure includes that audit and certification can 
only be carried out by  BIS and requires factory visit as part of scheme. Indonesia regrets that India 
has not taken into account the current pandemic situation that made factory visits impossible due 
to the travel ban and social distancing policy. Therefore, Indonesia urges India to consider the use 
of remote assessment in conducting factory visit or any relaxation policy as a means to facilitate 
trade and minimize technical barriers to trade, particularly in this difficult time. Indonesia also 
encourages India to recognize and accept conformity assessme nt results performed by accredited 
conformity assessment bodies outside India under the framework of IAF and ILAC signatory. 
Indonesia is also aware that before the mandatory implementation of IS 16192, India requires all 
manufactures of automobile wheel r ims to implement ICAT (International Center for Automotive 
Technology) Standard prior to entering India's market. Therefore, we would like to ask clarification 
from India regarding the implementation of the ICAT standards once this regulation comes into 
force. Indonesia remains concerned about the potential duplicative conformity assessment G/TBT/M/84  
 
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  procedure. Hence, Indonesia requesst India to harmonize both requirements with a single conformity 
assessment procedure.  
4.131.   In response, the representative of India provide d the following statement. Wheel Rims: The 
testing and certification system in India is in line with the global regime. Component certification is 
an essential prerequisite of Whole Vehicle Type Approval, and the two are complementary. This 
practice is wel l established worldwide and quite harmonised 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 wheel rim is recognized as one of the critical safety  components under 
CMVR. This has been warranted keeping in view the local road infrastructure, variety of tyres used 
and driving behaviour in India. Wheel rim is a critical part influencing driving safety. These Indian 
standards have been prepared to ensur e quality, reliability and consistency required, keeping in view 
human safety and consumer protection. These standards prescribe wheel rims' general and 
performance requirements intended for use on two, three and four -wheeled motor vehicles. The 
Quality Co ntrol Order (automotive wheel rims) is non -discriminatory, both at the original fitment 
level of automobiles and after sales/repair service, to ensure supply of only quality product in the 
Indian market duly certified approved by the Indian implementing ag ency. The QCO also provides 
for market surveillance to check the 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 stake holders. Further, as desired by the stakeholders, a sufficient lead time of 
one year from the date of publication of the Gazette Notification of the QCO has been provided for 
the industry to prepare itself.  
4.132.   Safety Glass: Implementation of safety glass QCO has been again extended by one year 
beyond 1 April 2021, i.e. new implementation date is 1 April 2022. Foreign inspection visits are on 
hold due to the prevalent restrictions on international travel given the ongoing COVID -19 pandemic. 
As soon as the situa tion of COVID -19 improves and the restriction lifted, India will plan the 
inspections (factory visit). Helmets: India is the largest two -wheelers market in the world. Around 
15 million two -wheelers are sold in the country every year. The Government and the  Apex Court, 
i.e. Supreme Court, are focussing hard on policies and measures to make people wear proper 
helmets while riding two -wheelers. In this regard, there was a move to reduce the maximum weight 
of the helmets so that people should use helmets, and B IS had issued the notification in this regard 
which prescribed for the maximum weight of helmets to 1200 grams from earlier 1500 grams. But 
due to the demand from the foreign helmet importers the cap on weight from 1200 was extended 
to 1500 grams. Now ther e is a proposal for including the helmet in the compulsory certification 
regime. This will ensure that the helmets are manufactured or imported only with the specifications 
of BIS standard and ensure good quality helmets, ensuring proper protection and red ucing fatalities. 
The BIS provides a mechanism for foreign manufacturers to obtain BIS certification, enabling them 
to sell in India. Considering the road safety scenario in India as above, which is quite different from 
any European countries, the requirem ents for certified helmets is a high priority.  
4.1.3.10   Kingdom of Saudi Arabia, Kingdom of Bahrain, State of Kuwait, Oman, Qatar, 
Yemen, United Arab Emirates - Halal Feedstuff, G/TBT/N/SAU/1134,  G/TBT/N/ARE/474,  
G/TBT/N/BHR/574,  G/TBT/N/KWT/532,  G/TBT/N/OMN/407,  G/TBT/N/YEM/176,  
G/TBT/N/QAT/570  (ID 64335) 
4.133.   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 and refer to its 
writte n comments of 12 June 2020. The European Union would also like to thank to the Kingdom of 
Saudi Arabia for the reply to the EU written comments. The European Union would like to reiterate 
that the condition of the use of Halal feedstuff for imports of anim al products for human consumption 
certified and labelled as h alal would require a significant alteration to the feeding regime for food 
producing animals in the EU and would negatively affect EU exports to GCC countries. The European 
Union would like to as k GCC countries and Yemen to reconsider this requirement for animals reared 
in non -GCC countries and Yemen. 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.  
 
35 For previous statements follow the thread under ID 643 . G/TBT/M/84  
 
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  4.134.   In response, the representative of the Kingdom of Bahrain  provided the following statement. 
On behalf of the member States of the Gulf Cooperation Council: We would like to thank European 
Union fo r their interest and is pleased to clarify the following. The "Halal Feedstuff " regulation covers 
the requirements to be followed during the production, preparation, handling, transport and storage 
of Halal feed for food -producing animals. The GCC member s tates would like to invite interested 
Members to discuss this matter bilaterally.   
4.1.3.11   Mexico - Conformity Assessment Procedure under Mexican Official Standard 
NOM -223-SCFI/SAGARPA - 2018, "Cheese Names, Specifications, Commercial 
Information, and Test Methods ," published on 31 January 2019, G/TBT/N/MEX/465  (ID 
67836) 
4.135.   The representative of the United States  provided the following statement.  On 5 May 2020, 
Mexico notified the World Trade Organization (WTO) of its draft conformity assessment procedures 
for cheese included in its Official  Mexican Standard (NOM) -223, including name, specifications, 
commercial 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 August 14 and September 
11, including providing expert presentations on standards of identity for cheese by the US 
Agricultural Marketing Service and the Food and Drug Administration. The US Department of 
Agriculture was also a regular participant. The opportunity to provide comments to the Mexican 
regulatory process and participate in the working group are greatly valued a nd we took sincere 
interest in participating. The United States and 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.  
4.136.   In its notification,  Mexico listed the objective of the conformity assessment procedures as 
the prevention of deceptive practices and consumer protection. Our understanding is that the 
conformity assessment procedures are required to determine the quality and truthful marketi ng 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 f ound any evidence in relevant scientific 
and technical information and incidence of non -compliant products to justify this onerous certification 
scheme for the objective of preserving the quality of cheese in the market? The July 2020 United 
States comment s on the draft NOM -223 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 requireme nts 
to label cheese made from vegetable fat as "imitation, " and existing requirements for certificates of 
analysis, which include information on cheese formulation, including 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 improve the quality of cheese or inform Mexican consumers. We also made suggested less trade -
restrictive suggestions alternatives to improve Mexico's labelling practices for cheeses derived from 
veget able 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 could 
further force consumer substitutions for lower -quality products.  
4.137.   Our industry also recommended conformity assessment alternatives that would achieve the 
objective 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 issuance of a specific NOM for  products made 
with vegetable fat, which would provide separate requirements for cheese considered "imitation ", 
(iv) application of the vo luntary 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 misleading labelling of imitation 
products; and are reasonably available to competent authorities. We recommended and requested 
Mexico continue the use of international sta ndards and test methods, and to consider suppliers' 
declaration of conformity as a means to attest that any required testing procedures had been 
performed. When we met bilaterally with Mexico in October 2020, we asked that Mexico recognize 
 
36 For previous statements follow the thread under ID 678 . G/TBT/M/84  
 
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  and accept testi ng from conformity assessment bodies located outside of Mexico, to ensure testing 
could be performed at the point of production.  
4.138.   Despite participating in early 2018 drafting, providing comments to CONAMER in 2018, 
providing comments in response to WTO TBT notification in July 2020, and expert participation in 
the working group in August through September 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. Our understanding is that Mexico is considering the 
conformity 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 batch every 24 hours. The third -party certification scheme will also requi re 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 certification scheme and facility inspection for 
every batch and family of produc ts contemplated in these final conformity assessment procedures 
is the kind of scheme typically created and intended for situations where the objective is safety. An 
example of the type of product 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 be considered 
more trade restrictive than necessary to fulfill the legitimate objective of the regulation. We request 
Mexico halt the issuance of the final cheese conformity assessment procedures, re -consider the risks 
that non -conformity would create before issuing the final conformity assessment procedure, and go 
back to drafting the conformity assessment procedure with trading partners and stakeholders.  
4.139.   Further, this would be an entirely new certification scheme that has never existed in any 
other country previously for cheese. If this certification scheme is includ ed 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 capabilities 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 take time for 
producers to employ testing and certification bodies and to inspect the produ ction 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. Additionally, any product sold 
to Mexico would suffer incre ased prices to offset the cost of these conformity assessment procedures. 
Those additional costs – for testing, services of a certification body for factory inspection, 
certification, surveillance, and traceability would put some US producers of cheese ent irely 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, and purchase of adulterated and unregulated cheese could increase. The United States 
exported USD 428 million in cheese to Mexico in 2020. We again request Mexico suspend the final 
measure, keep drafting with trading partners and stakeholders, consider the low -risk nature of 
cheese, and allow for su ppliers' declaration of conformity to attest compliance to the testing 
procedures required in NOM -223. 
4.140.   The representative of Australia  provided the following statement. Australia would like to note 
its concerns that Mexico's measure notified as G/TBT/N/MEX/465  appears discriminator y and more 
trade restrictive than necessary. We provided comments to Mexico's notification detailing our specific 
concerns with the measure. Australia welcomes Mexico's consideration of, and response to, these 
comments and looks forward to continuing our s uccessful trade relationship.  
4.141.   The representative of the European Union  provided the following statement. The European 
Union would like to join again 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 frequency 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.  
4.142.   In response, the representative of Mexico  provided the following statement. The 
characteristics of Official Mexican Standard NOM -223-SCFI/SAGARPA -2018, Cheese Names, G/TBT/M/84  
 
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  specifications, commercial information and test methods, mean that it meets the requirements of a 
Technical Regulation according to the provisions of the Agreement on  Technical Barriers to Trade of 
the World Trade Organization. It sets out four major components to which products must conform 
to be named as "cheese" in order to be marketed in Mexican territory. These are:  physico -chemical 
specifications for each type of  cheese (water content, protein and fat);  the product is made only 
from milk and includes no more than 2% of caseinates;  replacing milk fat by vegetable fat is not 
permitted; and  commercial information is provided on the specific label for this product.  The failure 
to comply with any of the above components would mean that effective compliance with this 
Technical Regulation cannot be demonstrated. Work is therefore ongoing internally with the relevant 
authorities in Mexico on a conformity assessment procedu re to provide certainty of compliance with 
the requirements of NOM 223, adhering to Mexico's international commitments, including equal 
treatment of infrastructure or conformity assessment bodies nationally and in foreign countries, as 
well as non -discrimi natory treatment between domestic and foreign producers.  The Government of 
Mexico reiterates its commitment to the Members of this Committee to keeping them informed about 
the development of this procedure; we will be reporting on this as soon as the inter nal work under 
way with the relevant authorities tasked with drafting this CAP has been completed.  We thank the   
European Union for its interest in discuss ing bilaterally  and invite the EU to get in touch.  
4.1.3.12   Thailand - Ministerial Regulation Prescribing Des cription, Production, and 
Method of Displaying of Standard Marks on the Industrial Products, G/TBT/N/THA/577  
(ID 67237) 
4.143.   The representative of the United States  provided the following statement.  The United States 
appreciates Thailand extending the date of enforcement of its Ministe rial Regulation prescribing the 
description, production, and method of displaying of Standard Marks on its Industrial Products to 
20 July 2021. The United States industry has submitted several comments through the US and Thai 
Enquiry Points beginning in Oc tober 2020, through January 2021. We appreciate the exchange 
through that mechanism. However, the United States does have continued concerns regarding the 
QR code requirements. We encourage Thailand to consider other approaches that may meet 
consumer prote ction goals in a less burdensome manner. In particular, a voluntary e -labelling 
approach in line with international best practices and standards should be considered. An e -labelling 
programme can help consumers discover important information without unnece ssarily raising 
compliance costs and slowing time to market. We also request that the Thai Industrial Standards 
Institute (TISI) kindly provide clarification on the paperwork factory inspection process and the fee 
for each shipment. We understand that TISI  indicated that a paperwork factory inspection is only 
valid for one shipment. We encourage Thailand to reconsider this duplicative and burdensome 
approach which would require a new inspection and fee for each shipment without improving the 
safety or quali ty of the products.  
4.144.   We further understand that the price of a paperwork factory inspection is almost three times 
higher than the usual onsite factory inspection price. Can TISI please provide more information 
about this cost structure and explain the diffe rence in scope and objectives between these two 
inspection processes? We appreciate TISI's flexibility regarding the labelling requirement for small 
batteries. However, we also request that TISI simplify the requirements for the TISI logo and QR 
code for u se on small AV products. We also request TISI remove the requirement for the importer's 
name to be imprinted on the power cord. If this requirement is maintained, efforts should be made 
to minimize the impact of this requirement, such as simplifying the re quirements for the importer's 
name to be listed on a paper tag rather than molded or labelled on the power cord. The United 
States requests that Thailand continue to examine the regulation and consider less burdensome 
conformity assessment and labelling re quirements to meet the legitimate objective of consumer 
protection.  
4.145.   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) and the paper work factory inspection process and fee. For the Ministerial 
Regulation Prescribing Description, Production and Method of Displaying of Standard Marks on the 
Industrial Products B.E.2563 (2020), we reiterate it is necessary that the regulation be promulgated 
to fulfill legitimate objective under the scope of the TBT Agreement, Article 2.2, whose purpose is to 
prevent decep tive practices and consumer protection. The ministerial regulation stipulates that the 
 
37 For previous statements follow the thread u nder ID 672 . G/TBT/M/84  
 
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  electronic information shall be displayed clearly visible, prominently and indelible on industrial 
products. In case where the electronic information cannot be displayed  on the industrial products, 
the regulation is allowed to display on a package, a container, wrapper or binder in order to facilitate 
the manufacturing process. The date of enforcement is extended for 180 days which will be entered 
into force on 20 July 20 21. As you may know, the spread of COVID -19 has been affected to factory 
inspection abroad. Import licensing, type 1b according to ISO/IEC 17067, widely accepted, has been 
applied during this hard period of time and product testing result of each batch shi pment shall be 
submitted instead of visiting the production site. Finally, we would like to propose a constructive 
dialogue with the United States for our better understanding.  
4.1.3.13   India - Refrigerating Appliances (Quality Control) Order, 2020, 
G/TBT/N/IND/173  (ID 67138) 
4.146.   The representa tive of the Republic of Korea  provided the following statement. Korea respects 
the efforts of India to protect consumers and Korean companies are fully committed to complying 
with the regulations of India. Korea would like to make some comments regarding t he "Refrigerating 
Appliances (Quality Control) Order, 2020 " as follows. On 28 January 2021, via the Indian WTO TBT 
Enquiry point, Korea submitted comments in regard to Clause 14.8 of the Indian standard IS 
1476(Part1):2000 and Clause 19.8 of IS 15750:2006.  In the letter, Korea asked India to consider 
revising the High Voltage Test Time to one second in accordance with the international standard 
(IEC 60335 -1). Since then, Korea has received two responses from India. On 2 February, India 
replied that India's BIS was working on revising its standard and would consider changing the High 
Voltage Test time from two seconds to one second. However, at the 24 February 2021 TBT 
Committee Meeting, India stated that India's standards and testings on refrigerating applia nces have 
been established after collecting opinions from relevant stakeholders and manufacturers, and the 
regulations would not hamper foreign companies from entering the Indian market. These two 
responses from India do not seem unambiguous on whether the  standard in question is under 
revision or it is set to be implemented without any further revision. Therefore, Korea asks India to 
clarify India's current position on this matter of revising the standard of the High Voltage Test and 
requests India once ag ain to harmonize its standard with the relevant international one. In addition, 
Korea requests India to implement the "Refrigerating Appliances (Quality Control) Order, 2020 " after 
the relevant Indian standard revision is completed and a sufficient transit ion period has been 
provided.  
4.147.   In response, the representative of India provided the following statement.  The standard has 
been chosen after due stakeholder consultation including industry associations. As per the note in 
QCO notified in gazette, "the late st version of Indian Standards including the amendments issued 
thereof, as notified by the Bureau of Indian Standards from time to time, shall apply from the date 
as notified by the Bureau " QCO was notified on 10 December 2020 with implementation date of 
1 January 2022 thus providing sufficient time for the industry to prepare. Since Korea mentioned 
about confusion between the two responses it received in the past, we hope this reply provided the 
required clarification.  
4.1.3.14   Kingdom of Saudi Arabia - Air Conditi oners - 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 66839) 
4.148.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the efforts of the Kingdom of Saudi Arabia to protect the environment and Korean companies are 
fully committed to complying with the regulations of Saudi Arabia.  At the February 2021 TBT 
Committee Meeting, regarding the Saudi Arabian regulation on "Air conditioners' Energy -Efficiency, 
notified as G/TBT/N/SAU/1167 , Korea requested Saudi Arabia to reconsider the newly added Clause 
7.4., which requires the disclosure of additional informati on on "AC setting for partial load operation". 
Also, Korea asked to ease the requirement of energy efficiency certification renewal for products 
with specifications identical to the existing products already certified. This relaxation can be achieved 
by either granting an exemption to relevant certification renewal or allowing companies to apply for 
the renewal with the existing test report used for initial certification. The Kingdom of Saudi Arabia 
responded that it would reply to Korea's comments via the WTO TBT Enquiry Point after reviewing 
the current status on Saudi air conditioners energy -efficiency regulations' standards. However, we 
 
38 For previous statements follow the thread under ID 671 . 
39 For previous statements follow the thread under ID 668 . G/TBT/M/84  
 
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  have not received any reply yet. Therefore, Korea requests Saudi Arabia to provide quick answers 
to our concerns.  
4.149.   In re sponse, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia would like to thank the Republic of Korea for addressing this concern. We 
would like to clarify that Saudi Arabia changed the requirements of submittin g the additional 
documents to be only submitted electronically via the SASO website. Thus, the exposure of 
intellectual property of technologies from manufacturers will be secured and will not be exposed to 
the public. Regarding the renewal process, a team  is currently working on studying the increasing 
validity period of test reports, and it will be announced once the study is completed.  
4.1.3.15   Indonesia - Halal Product Assurance Law No. 33 of 2014 and its implementing 
regulations, G/TBT/N/IDN/123,  G/TBT/N/IDN/131,  G/TBT/N/IDN/131/Add.1  (ID 
50240) 
4.150.   The representative of Australia provided the following statement. Australia welcomes 
ongoing discussions on the Indonesian Halal Product Assurance Law no.33 of 2014 (Halal Law) and 
continues to seek for the law to be implemented transparently and in close communication with 
busines ses and trading partners. We encourage Indonesia to continue to facilitate an open dialogue 
with trading partners to allow foreign businesses and their valued Indonesian importers to remain 
adequately informed of Halal Law implementation regulations. Austr alia thanks Indonesia for its 
notification to the TBT Committee in February of its Government Regulation 39/2021 on The 
Organization of Halal Product Assurance ( G/TBT/N/IDN/131 ), and subsequent addendum in May 
regarding the measure's entry into force ( G/TBT/N/IDN/131/Add.1 ). Australia appreciate d the 
opportunity to provide formal comments of the regulation and looks forward to Indonesia's response 
to our submission. Australia welcomes further dialogue on the Halal Law to ensure its implementation 
is no more trade restrictive than necessary.  
4.151.   The representative of the United States  provided the following statement. The United States 
supports Indonesia's goal to provide reliable, relevant information regarding the halal integrity of 
certain products to consumers and we have sought to work with Indone sia over the last seven years 
to ensure that objective is achieved without creating any unnecessary barriers to trade. However, 
we were disappointed to learn that the draft implementing regulation had been finalized and 
published as Government Regulation 3 9 of 2021 (GR 39/2021) on 2 February 2021, prior to its 
notification to this Committee on 12 February 2021 as G/TBT/N/IDN/131 . The addendum notification 
also noted entry into force began 2 April 2021, before the end of the sixty -day comment period. As 
you know, the recommended comm ent period for proposed regulations is 60 to 90 days and the 
reasonable interval for implementation is six months. We respectfully remind Indonesia of its WTO 
obligation to notify draft measures to the Committee, allow a reasonable time for stakeholder 
comments, and take such comments into account before draft measures are adopted and 
implemented. We request that Indonesia clarify the scope of the products and services covered by 
GR 39/2021. Article 2 states that all goods and/or services relating to food, beverage, medication, 
cosmetics, chemical products, biological products, genetically engineered products, or useful goods 
must undergo mandatory halal certification. This conflicts with the scope outlined in Decree 464.  
4.152.   Does Indonesia intend to develop imp lementing regulations or guidelines for each listed 
product category? What is the envisioned timeline for this development and will Indonesia conduct 
stakeholder consultations prior to issuing such implementing regulations or guidelines? Concerning 
the req uirement for a government -to-government MOU to continue recognition of foreign halal 
certifiers, the United States Government does not have oversight on halal products as Indonesia  
does. We understand Indonesia intends to continue to accredit overseas hala l certifiers and that 
these organizations will be permitted to assess the conformity of products intended for export to the 
country. Can Indonesia provide an update on BPJPH's process and timeline for renewing existing 
accreditations and adding new US -based halal certifiers? Will Indonesia consider renewing these 
accreditations in the absence of a government -to-government MOU to prevent trade disruptions? 
We request that Indonesia continue to accept goods imported from countries without a government -
to-government MOU? Can Indonesia also assure the United States that goods coming from a non -
MOU country will not be treated less favourably than goods from those countries with an MOU? We 
understand this measure also contains labelling and colour -coding requireme nts for non -halal 
products. We note that this new non -halal labelling scheme will significantly increase compliance 
 
40 For previous statements follow the thread under ID 502 . G/TBT/M/84  
 
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  costs and we question its utility, as halal products are labelled. Would Indonesia consider removing 
this non -halal labelling requirement?  
4.153.   The United States is also highly concerned that the measure mandates halal and non -halal 
product separation at every stage with regards to the location, areas, and equipment for the 
slaughtering, processing, storage, packaging, distribution, sales, and pres entation of all products. 
The United States requests that Indonesia refrain from implementing the supply -chain and product 
segregation requirements contained within GR 39/2021 and/or consider their applicability by sector. 
These requirements are unclear an d a burden to trade. Industries have means across their respective 
supply chains to maintain the integrity of halal products. Can Indonesia open public consultations 
on this requirement? It also appears that GR 39/2021 requires that each business operator must 
employ a halal supervisor. To the best of our knowledge, no other country, international 
organization, or international standard requires each individual business operator to employ a halal 
supervisor and such an overly burdensome requirement would co nstitute a significant obstacle to 
trade. Given the uncertainty and potential trade -restrictiveness of this measure, we request 
Indonesia to suspend this measure and the implementation schedule until Members' comments have 
been taken into account. We urge Indonesia to consider Members' comments, revise and renotify 
the measure, and reset the phase -in schedule for all projects covered by the revised measure.  
4.154.   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 again its concerns about the draft of Government Regulation Regarding 
Implementation of Halal Product Assurance. The requirement that non -halal p roducts must include 
information about non -halal ingredients on the labelling is unnecessary and overly burdensome for 
the manufacturers of non -halal products. In our view, products that do not display a halal 
certification will not cause confusion with ha lal products. Please re -consider the necessity of this 
labelling requirement. In addition, the need for a government -to-government mutual recognition 
arrangement as a pre -condition for recognition of foreign halal certificates represents an excessive 
burde n for Members who have no governmental body to administer halal affairs. We would 
appreciate Indonesia showing flexibility on this issue, such as allowing cooperation on halal 
accreditation between the BPJPH and foreign halal accreditation organizations. W e hope our 
comments can be taken into consideration as the regulation approaches finalization.  
4.155.   The representative of the European Union  provided the following statement. Thank you to 
Indonesia for the bilateral discussions. The European Union reiterates it s serious concerns on the 
Indonesian Halal Product Guarantee Law No 33 of September 2014 and its implementing provisions, 
which require mandatory Halal certification and labelling for a very wide range of products to be 
placed on the Indonesian market, res ulting in significant obstacles to 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 Guarantee Law and Implementing Regulation No 31/2019. The EU 
thanks Indonesia for its reply of 18 March 2021 to comments on Implementing Regulation 26/2019 
on the Facilitation of Halal Product Assurance. However, we kindly invite Indonesia to reply to EU 
comments of 12 May 2020 on Regulation 31/2018 on Processed Food Labelling, as well as to EU 
comments of 20 April 2021 on the draft Government Regulation (RPP) 39/2021 on Halal Product 
Assurance implementing the Omnibus Bill on Job Creation (Law 11/2020), submitted on 20 April 
2021. More broadly, the EU encourages Indon esia to provide comprehensive information to Members 
on the status of implementing provisions. The EU stresses the excessive restrictive impact on trade 
of the measures in question and invites Indonesia to consider less restrictive alternatives.  
4.156.   The main issues of concern for the EU in the current measures are, among others, the "non-
Halal" information requested for non -Halal products or the extension of Halal requirements to 
products other than food and beverages. Furthermore, in order to ensure the worka bility of the 
system for foreign operators, there is a need for more clarity and a pragmatic approach as regards 
the requirements for recognition by Indonesia of foreign Halal certificates. In particular, we consider 
that the pre -condition of a government -to-government mutual recognition arrangement for 
recognition of foreign Halal certificates represents an excessive burden for economic operators and 
does not allow for smooth trade relations. The additional registration requirement for Halal 
certifications  of certain products by foreign bodies also appears to be an unjustified, costly and 
duplicative request. The EU urges Indonesia to review these measures with a view at adopting a 
more trade -friendly approach. Notably, the EU firmly calls upon Indonesia to : (i) keep Halal 
certification and labelling voluntary, in order to pursue the legitimate objective of ensuring reliable 
information without unduly hindering trade flows; and (ii) accept test reports from EU laboratories G/TBT/M/84  
 
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  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 reiterates its willingness to further discuss and cooperate on Halal issues with 
Indonesia, with the aim of finding a practical way forward and solve trade concerns.  
4.157.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank Indonesia 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 stipulate the type of products 
that must be halal certified. We ask for some clarity on the status of Halal Certification Organisations 
whose certification will soon expire or has already exp ired with MUI, and whether there are any 
transitory arrangements in place for them to continue to certify before the conclusion of Mutual 
Recognition Arrangements or other agreements. We appreciate any further information from 
Indonesia as to whether there  are any other regulations relating to Halal under 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, an d welcome any 
further clarification on this. We thank Indonesia for notifying G/TBT/N/IDN/131  Draft of Government 
Regulation Regarding Implementation of Halal Product Assurance, to which we have submitted a 
number of questions and comments. We look forward to receiving Indonesia's comments on this in 
due course. We also seek clarity regarding the recent notification of Government Regulation Number 
39 of 2021 ( G/TBT/N/IDN/131/Add.1 ). This Regulation was originally notified by Indonesia on 
12 February as a draft in G/TBT/N/IDN/131  seeking comments from Members by 13 April 2 021. 
However, notification G/TBT/N/IDN/131/Add.1  indicates that Government Regulation Number 39 of 
2021 was adopted on 2 February 2021 and entered into force on 2 April 2021. We respectfully 
remind Indonesia of its obligation to notify its regulations at an early approp riate stage so that 
amendments can still be introduced and comments from other Members taken into account, as well 
as its obligation to provide a reasonable period of time between adoption of a measure and its entry 
into force.  
4.158.   The representative of Canada  provided the following statement. While Canada appreciates 
Indonesia's transparency in notifying this measure, we would like to remind Indonesia of its WTO 
transparency obligations to provide trading partners with adequate time to comment on a given 
measu re and have those comments taken into consideration prior to that measure being finalized. 
Canada was concerned to see that the draft implementing regulation had been finalized 2 February 
2021, prior to its notification to this Committee on 12 February and  during the allowed comment 
period – during which Canada sent comments to Indonesia. The addendum notification of 12 May 
2021 also noted entry into force on 2 April 2021, before the end of the comment period. In its 
comments, Canada signalled some remainin g concerns on the draft implementing regulation. For 
example, it is still unclear on how foreign halal certification bodies will be recognized under 
Indonesia's law, particularly in countries such as Canada where the government does not provide 
oversight f or halal certification. Some of the requirements necessary to obtain accreditation, such 
as the requirement that halal auditors hold Indonesia citizenship, would appear to be inappropriate 
for foreign certification bodies. Clarity around anticipated/expect ed timelines for the accreditation of 
foreign bodies would also be useful.  
4.159.   While Canada supports Indonesia's right to ensure the integrity of products that are certified 
as Halal, some requirements, including that separate facilities be used to store clean ing equipment 
for halal and non -halal slaughter, are neither financially or technically feasible for Canadian food 
producers and could impede their ability to export to Indonesia. Canada would like to explore 
Indonesia's openness to consider feasible alter native solutions that would achieve the same results 
(halal certified food products). There is also a lack of clarity around whether foreign halal certifying 
logos will be permitted in the Indonesian market. Could Indonesia inform if it will accept equival ent 
or alternative logos for imported products? Does Indonesia intend to develop implementing 
regulations specifically for acceptable logos, labels and other packaging requirements? In addition, 
concerns still remain with some of the proposed requirements including that non -halal products are 
required to display non -halal information on products, whether non -halal products can be imported 
and what constitutes "processing ". Canada takes this opportunity to remind Indonesia that as per 
WTO transparency obliga tions, a six -month period between the notification of the final measure and 
its entry into force is considered a reasonable amount of time to provide industry time to adapt to 
the new requirements. We appreciate Indonesia's willingness to discuss these iss ues bilaterally and 
we look forward to having a more in -depth discussion in a bilateral context.  G/TBT/M/84  
 
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  4.160.   In response, the representative of Indonesia  provided the following statement. Indonesia 
would like to refer to its statement on the previous TBT meeting on Fe bruary. Indonesia is mindful 
of its transparency obligations as mandated in the TBT Agreement. Thus, Indonesia has notified the 
Government Regulation Number 39 of 2021 on Implementation of Halal Product Assurances through 
addendum notification G/TBT/N/IDN/131/Add.1 . In this regard, we would like to thank all Members 
who have provided comments and inputs to the draft regulation. Indonesia reconfirms the regulation 
revoke the Government Regulation Number 31 of 2019 in order to implement the mandate of 
Indonesia Omnibus Law . We would also like to reiterate that there are phases or stages to implement 
mandatory halal certification such as for food and beverage products will be effective on 17 October 
2024; while for non -food and beverage products will be effective on 17 Octob er 2026. Furthermore, 
Indonesia provides a transitory provision as mentioned in Article 169 to accommodate stakeholder 
and industry that obtained halal certification based on previous mechanisms, as follows: all  forms of 
cooperation with foreign halal cert ification body and accreditation agencies in other countries that 
were carried out before this government regulation is made, remain in effect until the period of 
cooperation ends; foreign Halal Certificate  recognized by MUI before this Government Regulati on is 
made, remains valid until the expiration of the validity period of the foreign Halal Certificate. 
Indonesia would like to reiterate its openness to international cooperation on Halal Assurance System 
based on the principle of mutual recognition and m utual acceptance in accordance with international 
regulations and practices.  
4.1.3.16   China - Cosmetics Supervision and Administration Regulation and Regulation for 
Notification of Non -special Cosmetics, G/TBT/N/CHN/1310,  G/TBT/N/CHN/1311,  
G/TBT/N/CHN/1331,  G/TBT/N/CHN/1453,  G/TBT/N/CHN/1454,  G/TBT/N/CHN/1459,  
G/TBT/N/CHN/1460,  G/TBT/N/CHN/1515,  G/TBT/N/CHN/1524,  G/TBT/N/CHN/1525,  
G/TBT/N/CHN/1526,  G/TBT/N/CHN/1527,  G/TBT/N/CHN/1539  (ID 57641) 
4.161.   The repres entative of the Republic of Korea  provided the following statement. Korea thanks 
China for responding to Korea's comments regarding the Specifications for Cosmetic Efficacy Claim 
Evaluation, the Specifications for Registration and Filing of New Cosmetic In gredients, and the 
Specifications for Cosmetic Registration and Filing. However, the reply from China did not give direct 
answers to Korea's enquiries but only gave a general explanation on the implementation of 
measures. As our concerns were not duly addr essed in the finalized version of the Specifications for 
Cosmetic Efficacy Claim Evaluation and the Specifications for Cosmetic Registration and Filing and 
so on, we would like to raise this STC once again. First, according to the Regulation, exporters to 
China are required to specify the sources and quality data of all ingredients in the application, which 
demands more information than what is required in other countries. Such information contains a 
number of trade secrets that are critical to businesses, and the requirement is more rigorous than 
necessary to fulfill a legitimate objective of guaranteeing product safety and consistent market 
norms. Therefore, Korea would like to request China to provide an evidence -based explanation for 
such requirement. Fu rthermore, according to Appendix 12 -16, businesses are required to submit 
documents that specify manufacturing processes and corporate standards regarding ingredient 
safety and product standards, which include detailed information on the processes and proc edures 
of product manufacture.  
4.162.   Second, the Regulations stipulate that the test results required for the registration of 
cosmetic products must be issued by testing laboratories that have obtained China Metrology 
Accreditation (CMA ) in compliance with the r egulation. However, only laboratories in China are 
known to have obtained CMA. Thus, Korea would like to request China to offer flexibility to foreign 
laboratories in granting CMA and to recognize test results issued by foreign laboratories or 
internationa lly recognized laboratories, including Good Clinical Practice (GCP) or Good Laboratory 
Practice (GLP). Third, pursuant to Article 13 of New Cosmetic Ingredients Authorization and 
Registration Regulation, in case of using alternative test methods, exporting  companies are required 
to provide equivalence evidence which proves their test results are equivalent to the results of in 
vivo toxicity testing method, or animal testing. However, we would like to request that the OECD -
approved and internationally recogn ized alternative test methods also be recognized without having 
to provide equivalence evidence. Fourth, regarding "the administrative Measures on Cosmetic 
Labelling ", Korea would like to request that China assure that the labelling requirement follow the 
internationally recognized practice so as not to be more trade restrictive than necessary. Especially, 
with respect to the labelling requirement of all ingredients in cosmetics, Korea invites China to 
maintain its current regulation on the declaration of t he ingredient list in cosmetics on the labels. In 
 
41 For previous statements follow the thread under ID 576 . G/TBT/M/84  
 
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  most countries, the declaration of ingredient list is applied to substances at a 1% or higher 
concentration. According to China's draft regulation, however, the declaration of ingredients for the 
substances  at a 0.1% or higher concentration is required, and the substances at a lower than 0.1% 
concentration are declared as "other ingredients in small amounts. " This requirement goes against 
the harmonization of international regulations.  
4.163.   As the "Administrative  Measures on Cosmetic Labelling " will cause great change, reasonable 
transition time is necessary to ensure business entity. Korea would like to request that China 
provides an adequate grace period, in order to adapt to a new cosmetic labelling regulation.  Fifth, 
under the Specifications for Cosmetic Efficacy Claim Evaluation, China still requires the disclosure of 
the summary of scientific evidence that supports cosmetic efficacy claims 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 provisions requiring the disclosure of information. 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 creati ng unnecessary obstacles 
to international trade.  
4.164.   The representative of the United States  provided the following statement. The United States 
unfortunately must reiterate our concerns with China's development of the implementing measures 
for the Cosmetics S upervision and Administration Regulation (CSAR). CSAR's final implementing 
measures, as published, will pose significant risks to companies' intellectual property, are not 
proportionate to cosmetics' low risk compared  to medical products, and may result in  less favourable 
treatment of imports than that accorded to like products of national origin. Both the draft measures 
and those published as final appear to continue to require extensive disclosures of trade secrets and 
confidential business information (C BI) that may  not be limited to what is necessary to assess 
conformity and fulfill CSAR's regulatory objectives. The United States and other WTO Members asked 
that China consider how CSAR could be made more similar with the approaches taken by regulators 
in other major cosmetics markets, in which cosmetics companies maintain responsibility for their 
products, making their data and other documentation available to regulators as needed upon 
request. This allows companies to safeguard their information. We are disappointed that NMPA has 
not pared back its extensive disclosure requirements to the information necessary to assess 
conformity, and we urge NMPA to do so. As regards current draft measures, we have the following 
concerns and questions: we are concerned that the draft Standards of Information File for 
Toothpaste (1539), may not distinguish how cosmetic toothpaste is tested compared to other types 
of general and special cosmetics, despite differing uses.  
4.165.   Regarding China's draft Administrative Measures on C osmetic Labelling (1515), the United 
States is concerned that the proposed regulation regarding foreign language text and use of 
trademarks or suggestive words, graphics or symbols, would create an unnecessary obstacle to 
trade. We ask China to clarify tha t the foreign language labelling is not required to match the Chinese 
label exactly so long as the required Chinese label and the foreign labelling do not conflict. We also 
ask that China not require companies to disclose the product manufacturer on the pr oduct label, as 
the label already requires the name of the responsible person and their contact information. Product 
manufacturer information is proprietary and available to NMPA via the product filing. Given the 
extensive comments provided by WTO Members and industry, can China advise if it intends to 
renotify an updated version of the Administrative Measures on Cosmetic Labelling (CHN 1515), 
before it is finalized? Can China clarify if this measure is mandatory? If it is mandatory, we are then 
unclear as to why China has yet to notify its draft standard for Good Manufacturing Practices for 
Cosmetics (cGMP). We ask that China notify the draft standard and clarify how relevant international 
cGMP standards such as ISO 22716 are used as a reference for the sta ndard, or alternatively, why 
these relevant international standards, or relevant parts of them, are inappropriate for the fulfillment 
of China's regulatory goals.  
4.166.   In addition to the above concerns on the draft measures, despite extensive engagement 
from th e United States, US industry, and other stakeholders, significant concerns remain over 
CSAR's recently finalized implementing measures. For example, we, as well as other WTO Members, 
continue to urge that China not require cosmetics rightsholders to public ly disclose CBI used to verify 
their product claims, as specified in Annex 4 of the Standards for Cosmetics Efficacy Claim Evaluation 
(Standards) (a draft of which was notified as 1526). Rather, companies should be allowed to limit 
public disclosures to a non-proprietary summary of the product, validation methods and outcomes G/TBT/M/84  
 
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  used to validate claims. We ask NMPA to confirm that companies, not NMPA, will be allowed to 
compile the product abstract published on NMPA's website. We are also disappointed that the se 
finalized Standards may require testing that may be more trade restrictive than necessary, if 
duplicative, of what is available from the use and testing of the product in other markets. We urge 
China to recognize test reports from foreign labs that do n ot have Chinese Metrological Accreditation, 
if they follow Good Laboratory Practices or Good Clinical Practices, per the ICH Guidelines, and are 
in conformity with China's requirements. Will China consider alternative means of validating these 
claims, not included in the Claims Guidelines, if the means are in conformity with China's 
requirements? The United States acknowledges the new language on intellectual property (IP) 
protections in Article 55 of the Administrative Measures on Cosmetics Registration an d Notification 
(a draft of which was notified as 1454), stating that authorities shall not disclose trade secrets and 
CBI, subject to exceptions for national security or major social public interests. The United States 
remains concerned, however, that Chin a's disclosure exceptions as provided in the Administrative 
Measures (1454) and the Regulation on the Disclosure of Government Information will undermine 
protections for trade secrets and CBI.  
4.167.   We heard that China may, in response to prior comments from the  United States and other 
WTO Members, develop an explicit mechanism for companies to indicate to NMPA when information 
submitted in line with the CSAR, its regulations, measures, specifications and standards, should be 
marked as trade secrets or CBI. We as k that this mechanism provide a means by which protections 
from unauthorized disclosures can be monitored and legally enforced within China. We are 
disappointed that China has not taken into account the concerns raised by several Members of the 
WTO TBT Com mittee, that the Provisions for Management of New Cosmetic Ingredient Registration 
and Notification Dossiers (draft of which was notified as 1525) may have the effect of requiring 
importers to animal test their products if they cannot provide a regulator -issued Good Manufacturing 
Practices (GMP) certificate. The United States has explained that the US Food and Drug 
Administration does not issue these GMP certificates. We note that several other WTO Members 
including the European Union, Australia and New Zea land have noted that such certificates are not 
relevant in terms of how they regulate cosmetics, and they have similarly asked China to consider 
other means to establish GMP conformity that are not trade restrictive. For example, in the United 
States, trad e associations and other third parties can issue certifications in line with the international 
GMP standard ISO 22716, which the US FDA and regulators in other major cosmetics markets 
reference. So as to avoid creating disparate treatment of imports or req uiring unnecessary animal 
testing, we ask that China consider how it can be flexible and transparent in determining which GMP 
certificates and/or production licences, it will accept as conforming to its requirements. To date, 
neither China's WTO TBT Commit tee delegation nor NMPA has responded to US Government or US 
industry enquiries for additional clarification. The United States appreciates China's most recent 
notifications of CSAR implementing measures and the opportunity to provide comment, however, 
we are deeply concerned by China's 1 May date for adoption of many of the final measures. We 
request that China delay finalization of additional measures until these serious trade concerns 
expressed by the United States and many other WTO Members are addresse d. 
4.168.   The representative of Japan  provided the following statement. With respect to "Cosmetics 
Supervision and Administration Regulation " and its implementing regulations, Japan continues to 
express the following concerns. 1. "Management Rules for Testing req uired for Cosmetic Product 
Registration and Notification ", which was promulgated on 12 September 2019, stipulates that 
microbiological, physical and chemical tests, toxicological tests and human safety and efficacy 
evaluation tests relevant to cosmetics re gistration and filing shall be conducted by the testing 
laboratories in China that obtained China Inspection Body and Laboratory Mandatory Approval 
(CMA). Japan appreciates that China took Japan's repeated request into  a certain level of 
consideration rega rding "Specifications for Registration and Filing of New Cosmetic Ingredients ", 
which was promulgated on 4 March 2021, stipulates that physical, chemical and microbiological 
testing reports relevant to new cosmetic ingredients registration and filing may b e issued by the 
registrants or filers themselves or by entrusting a testing institution with corresponding testing 
capabilities. Japan would like to request, relevant to cosmetics registration and filing, a more flexible 
framework in which test results obt ained by foreign laboratories with the equivalent qualifications 
and abilities as those of Chinese testing laboratories are accepted. In addition, regarding test 
methods, the implementing regulations of the "Cosmetics Supervision and Administration 
Regulat ion" stipulates that test methods including test items other than those stated above, can 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 G/TBT/M/84  
 
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  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.  
4.169.   2. The sales certification that proves the product s 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 favourably than products produced in China. In addition, regarding China's 
draft of the "Administra tive Measures on Cosmetic Labelling ", Japan would like to express its 
following four concerns. 3. Article  5 stipulates that the content of the added Chinese labels, such as 
information regarding product safety and efficacy, shall be consistent with the original labels. 
However, the original labels are designed to comply with regulations in the country of prod uction 
and it is natural that their 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 produc tion, and that the requirement will not be more trade 
restrictive than necessary to fulfill legitimate objectives. 4. Regarding Article 6, Japan has concerns 
that multiple company names and addresses on the label may cause misunderstandings on the part 
of the consumer rather than achieving the aims of this article to inform consumers of the persons 
responsible for product quality and efficacy. In order to avoid confusion among consumers, Japan 
would like to ask China that the label indicates a single respon sible person ( "cosmetics registrants 
or filers " or in the case of imported products, "responsible person in China"), and Japan considers 
that the label requirements regarding producers are not necessary.  
4.170.   5. With respect to the rules for labelling of all in gredients in cosmetics, there is an 
internationally 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 stipulates that only ingredients 
with a compoundin g amount of 0.1% or less are allowed to be listed in no particular order. It also 
stipulates that ingredients with a compounding amount between more than 0.1% and 1% are to be 
listed in descending order. Japan would like to request that China assure that t he rules for labelling 
follow the internationally recognized practice so as not to be more trade restrictive than necessary. 
6. Article 19 stipulates that the indication "evaluated and verified efficacy" can be included on 
product labelling only if the eff icacy is confirmed by the qualified testing laboratory in China. 
However, "Specifications for Cosmetic Efficacy Claim Evaluation ", which was promulgated on 9 April 
2021, stipulates that all efficacy should be confirmed by appropriate test methods. Japan wo uld 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 ", not limited to the one confi rmed by the qualified testing laboratory in China. Moreover, 
the "Provisions for Cosmetics Registration" stipulate that overseas inspections are to be conducted 
in accordance with relevant regulations of overseas inspections. Regarding "Interim Measures on  the 
Administration of Overseas Inspections of Cosmetics ", Japan would like to continue to express 
concerns on the following three points.  
4.171.   7. Japan would like to request that China clarify which laws and regulations are used to 
determine conformity and spe cific purposes for conducting overseas inspections. Japan also asks 
that China ensure that inspections will not be more trade restrictive than necessary, ensuring that 
the legitimate objectives under the TBT Agreement are fulfilled. 8. The subject of the i nspection 
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 product 
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 Chines e companies are only conducted on production sites. Japan would like to request 
that China stipulates equal treatment for both domestic and overseas companies. 9. Japan requests 
that China ensures that confidential information will not be disclosed to pers ons other than those 
who are necessary for the legitimate purpose of the inspection, since production sites also contain 
a large amount of confidential corporate information. Furthermore, Japan has the following concerns 
on other implementing regulations.  
4.172.   10. In "Specifications for Registration and Filing of New Cosmetic Ingredients ", there are 
specific requirements for nano ingredients and Annex 5 stipulates the definition of such ingredients. 
Article 29 of "Specifications for Cosmetics Registration and Fi ling" stipulates 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 Comments) " stipulates the rule for naming of 
nano ingredien ts in the product formulation table. Japan considers that a more detailed and concrete G/TBT/M/84  
 
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  standard is necessary to judge which ingredients fall under the definition of nano ingredients. In 
addition, Japan would like to request that the standard will be formul ated in a way that reflects 
international trends and comments from all stakeholders. 11. Regarding article 33 (II) (Exemption 
from submitting toxicological testing documents) of "Specifications for Cosmetics Registration and 
Filing ", since the legal 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 practice 
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. 12. Regarding the test 
of freckle -removing/whitening products, Japan would like to request that China adopt the approach 
of Read -Across that was stipulated in Article 16 (freckle -removing/whitening effect cross -reference) 
of "Specif ications 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 process from application to perm ission.  
4.173.   13. Japan would like to request clarification so that filers of toothpaste products can use new 
toothpaste ingredients only when registrants/ filers of new ingredients have confirmed their use in 
advance during the three -year safety monitoring peri od after their registration/ filing of new 
ingredients, in the same manner as article 29 of "Specifications for Cosmetics Registration and 
Filing ", which stipulates the handling of new cosmetic ingredients. 14. Article 32 of "Standards of 
Information File for Toothpaste Notification (Draft for Comments) " stipulates that the abstract of an 
efficacy evaluation report shall be submitted during the filing process. The "Cosmetics Supervision 
and Administration Regulation " stipulates that "cosmetics registrants o r filers " are the persons 
responsible for efficacy of cosmetic products, however, its implementing regulations do not require 
submission of the abstract of an efficacy evaluation report. Japan would like to know the reason for 
the requirement of submitting  the abstract of an efficacy evaluation for toothpaste. 15. Article 36 of 
"Specifications for Cosmetics Registration and Filing " newly requires that their registrants/ filers 
retain samples of each batch of cosmetics produced for future inspection. It also  stipulates that the 
number of retained samples shall be able to meet the requirements for conducting registration and 
filing tests. Retaining such samples from all lots requires prohibitive amounts of space and imposes 
substantial burdens. Japan would lik e to request that China stipulate detailed rules allowing for 
flexible operation, such as setting the storage period up to each sample's expiration date since 
overdue samples from their expiration data is unable to use as samples. 16. Finally, as the 
"Cosm etics Supervision and Administration Regulation " and its implementing regulations will cause 
great changes, reasonable time for transition is necessary to ensure business continuity. Japan would 
like to request that China provide an adequate grace period o f 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 o n current regulations are not subject to measures under the new regulations.  
4.174.   The representative of Australia  provided the following statement. Australia thanks China for 
providing a written response to Australia's previous comments on China's Cosmetics Sup ervision 
and Administration Regulation (CSAR). We appreciate China taking the time to provide this reply, 
which does help answer some of our questions in relation to the CSAR and some of its implementing 
regulations, including those notified in 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 ; G/TBT/N/CHN/1524 ; G/TBT/N/CHN/1525 ; 
G/TBT/N/CHN/1526 ; G/TBT/N/CHN/1527 ; and G/TBT/N/CHN/1539 . We understand that this new 
regulatory system was to enter into force from 1 May 2021. Could China clarify whether the CSAR 
and all the relevant implementing regulations are being implemented? We would also request an 
update on how implementation is progressing and whether any cosmetics have been imported to 
China unde r the new regulatory system. Does China intend to notify the WTO of the final versions 
of each implementation regulation? We understand China has notified only drafts of many of these 
regulations to date. Australia still has questions and concerns about ho w the CSAR and its various 
implementing regulations are to be implemented.  
4.175.   While Australia is pleased that China appears to have addressed the need for an alternative 
to mandatory animal testing for imported cosmetics, we are also mindful that such alterna tives 
should not in themselves raise new barriers that constitute an unnecessary impact on trade. In this 
respect, a key concern is the requirement for government involvement in certifying quality (e.g. via 
Good Management Practice (GMP)) of cosmetics prod uction facilities and the requirements to register G/TBT/M/84  
 
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  and certify low -risk cosmetic products even when these include approved ingredients. Exporters are 
also concerned about requirements to provide information on their production processes and other 
aspects o f their intellectual property. The Australian Government would welcome the opportunity to 
work with China and discuss the CSAR in more detail to exchange information on our respective 
health regulatory systems, including our respective systems for cosmetic s regulation and GMP 
certification.  
4.176.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
China's endeavours to modernize its regulatory system for cosmetics and also welcomes the 
opportunity to comment on specific elemen ts of China's Cosmetic Supervision and Administration 
Regulations. 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 implementation 
of the regulations. New Zealand notes that under the measures, non -animal tested cosmetics are 
able to enter China's market only on the basis that regulator -issued GMP certification is provided. 
Non-special use cosmetics are considered to be low -risk product s in many countries, including New 
Zealand, and for this reason are not subject to regulator -issued GMP certification. While we welcome 
the introduction of alternatives to mandatory animal testing for imported products, like others, New 
Zealand is disappoi nted that the measures do not provide for non -regulator issued GMP certification 
or other trade facilitative mechanisms for providing product assurances. This appears to mean that 
animal testing requirements will still apply for Members who cannot offer re gulator -issued GMP 
certification for cosmetics imported into China and as such will act as a significant and unnecessary 
barrier to trade for imported cosmetics products. New Zealand would like to better understand what 
consideration China has accorded to less trade -restrictive alternatives. We encourage China to 
engage directly with New Zealand and other affected Members to identify a trade -facilitative 
mechanism to demonstrate GMP conformity, without imposing animal -testing requirements.  
4.177.   New Zealand furth er requests that China also provide flexibility in respect of product testing 
requirements. In particular, we encourage China to accept test reports from accredited laboratories 
situated outside of China. If test reports from internationally accredited bod ies outside of China are 
not accepted, then this will create burdensome and unnecessary 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 o utside of China would be trade facilitative and in accordance with 
international best practice. New Zealand also holds concerns, that we note are shared by a number 
of Members, around the issue of China requiring more detailed disclosure of product formula s 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 dom estic market and so as not to compromise 
intellectual property. New Zealand looks forward to engaging further with China on its CSAR 
measures and welcomes China's response to the concerns raised by New Zealand and other 
Members.  
4.178.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Australia, the United States, Korea, Japan, and New Zealand. The 
notified drafts contain rules for the implementation of the new Cosmetics Supervision and 
Admin istration Regulation (CSAR). The EU is of the opinion that the clear steps outlined in the 
implementing rules for product and ingredient registration can lead to a faster and more efficient 
registration and filing mechanism. In particular, the obligation f or 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 t he disclosure of "the source of the ingredients and their quality 
specifications ", go beyond the CSAR principles in a way that they would create problems for the 
operation of cosmetic companies, including both domestic manufacturers and importers. The EU 
would like to point out that this kind of information, on a raw -material -by-raw-material basis is 
commercially sensitive and touches on intellectual property rights of the companies involved 
(suppliers and cosmetic manufacturers). Mandatory disclosure of th is information in the registration 
and filing process is therefore a significant concern for the EU. The EU is of the opinion that including 
this kind of information, as part of the in pre -market registration or filing dossier is not necessary to 
ensure co nsumer safety and traceability of the ingredients used in cosmetics.  
4.179.   Companies' registration and notification documentation may be accessible to a number of 
people including the pharmaceutical supervisory and administrative department, professional 
technic al institutions and their staff, and personnel participating in the review. Could China confirm G/TBT/M/84  
 
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  that all institutions and individuals that may have access to the submitted data will be subject to 
non-disclosure requirements? Have specific procedures and en forcement measures been developed 
to ensure the non -disclosure of submitted data? The EU has noted that no specific transition periods 
are indicated in the notified draft measures, however they will be a crucial "workability" factor for 
the successful impl ementation of CSAR and its implementing legislations. Given the amount of 
changes to industry practice that this implementing legislation will induce, the EU is of the opinion 
that a differentiated approach is needed between new products (two years) and pr oducts 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.  
4.180.   In response, the represent ative of China  provided the following statement. Requiring a 
registration applicant and the filing applicant to submit safety -related information is a common 
practice of other Members  for the safety review of health -related products. In China's cosmetics 
regulations, the procedures and data requirements for the registration and filing and new raw 
materials are focused and clear. The brief description of the production process, raw material 
production process, and other registration and filing materials requ ired in the regulations and 
submitted by enterprises are not the contents of government information disclosure. Government 
information disclosure is a measure for the government authorities to accept social supervision and 
protect the public's right to kno w. According to the Regulations on the Disclosure of Government 
Information, authorities are prohibited from disclosing information involving trade secrets and 
personal privacy that may harm the legitimate rights and interests of third parties. Therefore, trade 
secrets and intellectual property rights will not be damaged in this regard. China attaches great 
importance to the protection of trade secrets and IP of enterprises. Article 47, Article 56 of the 
Regulations on the Supervision and Administration of Cosmetics, as well as the Measures for the 
Administration of Registration and Filing of Cosmetics issued on 7 January 2021 all stipulate that the 
commercial secrets of the parties shall be kept confidential. Besides, in relevant technical 
requirements, onl y a summary of the efficacy claim basis rather than the full text is required in 
evaluation data of cosmetics efficacy claim. The technical requirements of new raw materials for 
disclosure only include some basic information, not complete technical informa tion. The authorities 
will also strictly abide by the principle of protecting business secrets in the management of cosmetics 
registration and filing.  
4.181.   Strengthening the supervision of cosmetics production is a necessary means to ensure 
product quality and safety. It is also a common practice internationally. Based on the non -
discrimination principle of WTO, the Provisions on the Administration of Cosmetics Registration and 
Filing Data put forward exactly the same requirements on imported and domestic cosmet ics for an 
alternative program of animal tests for safety evaluation. For the quality management system 
certification issued by the government agency, it is non -discriminate to domestic and imported 
products, for the purpose to ensure the quality and safet y of the products. On the submission of 
information related to the safety of cosmetics raw materials . As product safety is closely related to 
the safety of the raw materials, it is important to require the registration applicant and the filing 
applicant to  clarify the information related to raw material safety when applying for registration and 
filing, so as to ensure product safety. 4. In the aspect of cosmetics registration and notification 
inspections, to protect the legitimate rights and interests of Ch inese consumers, ensure the accuracy 
of test results, etc., National Medical Products Administration (NMPA) requires testing the efficacy 
of cosmetics in cosmetics registration and filing inspection institutions. However, foreign -funded 
inspection institut ions are not prohibited from serving as cosmetics registration and filing inspection 
institutions. At present, many laboratories of foreign -funded inspection institutions in China have 
obtained the CMA certification of cosmetics and undertaken cosmetics re gistration and filing 
inspections.  
4.182.   As a matter of fact, the Administrative Measures for Cosmetic Labelling (Draft for Comments) 
does not require that all contents of the Chinese sticker and original label should correspond to each 
other, but only requires that the content of product safety and efficacy claims indicated in the 
Chinese sticker should correspond to those of original label. Labelling of information of 
manufacturers is an important measure to protect consumers' right to know, and also an importa nt 
means to promote social co -governance and combat counterfeiting. The imported products can be 
labelled according to the requirements of relevant regulations, and there is no situation that it is in 
conflict with the information of manufacturers. In fact , the declared efficacy of products is closely 
related to the efficacy of cosmetic ingredients. In general, there is a positive dose -effect relationship 
between the efficacy of the ingredients and the amount added in the formulation. Therefore, in order G/TBT/M/84  
 
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  to prevent the "conceptual addition " of cosmetic ingredients, the proposed draft measures, based 
on the scientific supervision concept, propose that ingredients with formula content not exceeding 
0.1% (w/w) should be labelled with "other trace ingredients" a s guide words. "Other trace 
ingredients" does not equal to "ineffective ingredients", the ingredients which are of very low amount 
but still have some efficacy, and could be declared in the labelling for efficacy declaration on the 
premises that the regula tion requirements could be satisfied. On the transitional period for the  
implementation of regulations . On 29 June 2020, China has issued a new revision of the regulations 
on the supervision and administration of cosmetics, and come into effect on 1 January 2021. For 
other regulations on cosmetics, reasonable transition periods have been or will be provided as well.  
4.1.3.17   European Union - Transitional periods for MRLs and international consultations 
(ID 58042) 
4.183.   The representative of Colombia  provided the following statement. Colombia reiterates its 
grave concern regarding international consultation processes adopted and the transition periods 
granted by the European Union prior to the entry into force of provisions under which the EU no 
longe r 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 producers because of 
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 are already having a direct impact on fruit producers in Colombia. They create add itional 
burdens for agricultural producers, who need to make decisions on the use of crop protection 
products a year or more before the final product arrives on the European market.  This is particularly 
complex for products with long production and harvest  cycles as, while complying with European 
standards at the time of sowing, they may face regulatory changes that prevent exports at the time 
of harvest and distribution of the product. The same challenges arise in processed and frozen foods. 
For such produ cts, short transition periods can create situations in which imported products are 
discriminated against in favour of domestic products, as goods produced in accordance with the EU 
standards in force at the time of production may no longer be eligible to e nter 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 p articular crisis.  In line with the statements made in document 
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.  
4.184.   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 pr ocess. As provided in Articles 2.9.2 and 2.9.4, the notification must be submitted within 
a time limit that allows the Members concerned to submit substantive observations and comments 
for genuine consideration by whoever is developing the technical regula tion, in this case the 
Committee.  Within the framework of this Committee, it cannot be acceptable for the EU to state 
that, as soon as the European Food Safety Authority (EFSA) recommendation and the Standing 
Committee on Plants, Animals and Food and Feed (PAFF) opinion are known, countries should be 
able to "make the relevant adjustments", given that this information 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 th e day immediately after the end of the international consultation period, as this shows 
that the comments submitted 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 and 
the minimizing of market distortions.  Colombia once again welcomes the opportunity to express its 
concerns on this issue and looks forward t o a response from the European Union.  
4.185.   The representative of Costa Rica  provided the following statement. As in previous meetings, 
Costa Rica associates itself with the concern raised by the United States and Colombia, as well as 
with the request for extens ion 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 agricultural 
 
42 For previous statements follow the thread under ID 580 . G/TBT/M/84  
 
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  production in 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 toleranc es for different substances used in agricultural 
production.  In the current historical context in which the international community finds itself due to 
the COVID -19 crisis, the implementation of more restrictive measures or additional burdens on 
internatio nal trade in agricultural products constitutes a challenge that is hampering global 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 entr y into force of reductions of maximum residue levels (MRLs) 
for plant protection products in light of the COVID -19 pandemic.  
4.186.   The representative of the United States  provided the following statement. We continue to 
raise our concern about the European Union 's (EU) transitional 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 reca ll longstanding concerns that trading partners do not know with certainty what the impact 
of non -renewal decisions will be on future maximum residue levels (MRLs). In addition, we reiterate 
our concern about import tolerance applications, which remain acti ve. The review of additional data 
is often only considered after the EU notifies its intent to issue a non -renewal notice. Trading partners 
have found themselves racing to move shipments through customs fast enough to prevent rejections 
or turning back ord ers because a product that complies with an existing EU MRL standard at the 
time of production will face rejection at EU borders. EU growers do not face these restrictive timelines 
under the current regulatory provisions. Once again, the United States reit erates our request that 
the EU retain existing MRL levels while Import Tolerances are under consideration, conduct full risk 
assessments prior to setting new MRLs, and extend its MRL transitional measures to account for 
realistic production and processing times for food and agricultural products. We also again request 
that imported products' MRLs be considered on the EU market at the time of production, the same 
as for European products.  
4.187.   The representative of Ecuador  provided the following statement. Ecuador is extremely 
concerned about the "transition periods" granted by the EU for implementing its measures relating 
to the non -renewal of the use of substances and the reduction of tolerances. In order to establish 
reasonable transition periods, it is necessary to consider harvesting periods and the times when 
agrochemicals are applied. Farmers need more time to adapt to MRL requirements, as it takes 36 
months on average to develop or register a new phytosanitary pest -control product.  We therefore 
urge the EU to consider a period of at least 36 months, which will allow enough time to make the 
necessary adjustments to production and ensure that developing countries meet the new 
requirements established in the European reg ulations.  The extension for applying the measures has 
also been requested given that their implementation makes it necessary to find alternative measures 
that do not affect the price of agricultural products, and because of the need to minimize the impact 
of the reduction of agricultural production in the country, as it is important to bear in mind that 
according to data in the study carried out by the United States (USITC - Global Economic Impact of 
Missing and Low Pesticide Maximum Residue Levels), it is estimated that the strategies applied by 
the EU, in a middle -of-the-road scenario, would lead to the prices of agricultural products increasing 
by around 50% and a 4% decline in global agricultural production, which would have a huge impact 
on the country' s economy.  
4.188.   It is clear that the regulations on the prohibition of the use and the withdrawal of the 
molecules are of an internal nature for EU member countries; however, bearing in mind that the 
next step is to review and modify the MRLs for these molecule s and in some cases involves reduction 
to the level of detection, this would mean that the restriction on their use would also be reflected in 
exporting countries.  Ecuador is aware that the EU allows its farmers to request emergency 
authorizations so that,  in certain special situations, they can use active substances that have already 
been banned in the European market. For Ecuador, it is important to know whether, where 
emergency authorizations are issued for the use of such substances, EU member countries  have 
notified and justified the application of MRLs that differ from those established in the EU's existing 
MRL regulations. We would also like to know how the EU monitors whether the member State that 
has received an emergency authorization for the use o f prohibited substances is complying with the 
existing MRL regulations and how it verifies, in the case of non -compliance with the MRL regulations, 
that the products containing the prohibited substances have not been marketed in other EU member 
States.  G/TBT/M/84  
 
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  4.189.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
concern and asks for the statements made at previous meetings to be recorded in the minutes. We 
support Colombia's comments regarding the immediate publication of measure s at the end of the 
comment period and the apparent failure to consider these comments. We have asked the EU to 
provide concrete examples of when comments have been taken into account, without receiving a 
response that identifies such cases.  We once again ask to be granted  an appropriate period of time 
to adapt, reflecting the realities of the production processes and geographical locations, including 
the distances, of the EU's trading partners . The six -month period is insufficient for adapting 
productive s ystems.  
4.190.   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 refer to our previous statements 
regarding STC 580. We respectfully bring to the attention o f the EU its obligations under Article 2.12 
of the TBT Agreement, which relate to the establishment of a reasonable interval between the 
publication of technical regulations and their entry into force, except in cases of urgent problems of 
safety, health, environmental protection or national security. It is of utmost importance 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 i ndicate 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.  
4.191.   The representative of Canada  provided the following stateme nt. Canada would like to 
reiterate its concern with the EU's approach to transition periods for maximum residue limits. In our 
view, the sudden deletion of MRLs and import tolerances seem disproportionate to the level of risk 
to human health and is more tr ade-restrictive than necessary. Moreover, transition periods are not 
granted to third countries, making it very difficult for our domestic exporters to adapt to the new 
requirements. The current approach does not acknowledge the reality of agricultural sup ply chains 
such as multi -year inventory and extensive shelf life, including in foreign countries. Canada seeks 
confirmation that the EU will allow more reasonable transition periods for MRLs where the risks of 
dietary exposure are acceptable. Transition pe riods will allow trade to continue uninterrupted, while 
providing sufficient time for producers and exporters to adapt to the new EU requirements. At a time 
when ensuring food security is paramount, Canada urges the EU to extend transition periods for 
MRLs to third countries, taking into account the need for exporters to adapt to new requirements, 
as it has done so for its domestic producers.  
4.192.   The representative of Panama  provided the following statement. Like the delegations that 
have already taken the floo r, Panama wishes to reiterate its concern regarding the transitional 
periods established by the European Union.  Time is needed to adapt agricultural production to the 
standards and doing so within a six -month period is impossible. We refer to our previous statements 
on this matter and invite the European Union to promote open dialogue with stakeholders, 
transparency and the minimizing of market distortions.  
4.193.   The representative of Guatemala  provided the following statement. Guatemala wishes to 
reiterate the i mportance of the European Union granting transitional periods that closely follow the 
stages of crop production, in particular for crops grown in tropical countries. The productive sectors 
require more time to adapt and, in particular, find alternative sub stances, which in some cases 
means having to wait for suitable production cycles to commence application and testing.  We 
reiterate our concern that our ideas for focused discussions on finding solutions have not been heard 
and accepted. The trade concern r egarding this issue focuses on safeguarding agricultural producers 
and exporters exporting their products to the European Union, who will be affected by the change 
in the European Union's conditions.  We would be very grateful if the European Union could: ( i) 
establish genuine dialogue to discuss this issue; (ii) extend the transitional period, with a view to 
ensuring that trade is not obstructed any more than is necessary and giving time for developing 
countries with tropical climates to adapt; and (iii) pr ovide clarification on why our comments on this 
process in the WTO are not taken into account within the regulations.  
4.194.   The representative of Chile provided the following statement. Chile associates itself with the 
statements by Colombia, Costa Rica, the Uni ted States and the other delegations that took the floor 
on maximum residue levels.  
4.195.   The representative of Uruguay  provided the following statement. In view of harvesting 
periods, the stages at which plant protection products are applied, and the time requi red to develop G/TBT/M/84  
 
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  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 ens ure 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 sufficient period in this regard.  My delegation reiterates its call to 
Members to ado pt 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 sufficiently long to make 
the relevant adjustments.  
4.196.   The representative of El Salvador  provided the following statement. El Salvador also shares 
the concerns expressed by other delegations in rel ation to the different draft technical regulations 
of the European Union for MRLs. We would urge that these be based on scientific evidence and not 
constitute unnecessary obstacles to trade.  
4.197.   In response, the representative of the European Union  provided th e 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 
concerns on the setting of Maximum Residu e 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. On the contrary, all measures concerning non -approval or restriction of active 
substance s used in plant protection products in the EU are notified to the TBT Committee. These 
measures do not have direct consequences on SPS -related matters. However, in the interest of 
transparency and, further to requests by some Members, when notifying these measures under the 
WTO/TBT notification system, the EU additionally informs the SPS Committee of the submission of 
those notifications on pesticide active substances. In practice, both Committees are informed about 
draft acts on the non -approval or restric tion of approval of an active substance in the EU. However, 
comments should only submitted via the TBT notification system. The European Union would like to 
point out in this context that the commenting deadlines are always respected and that the comments 
received within those deadlines are duly taken into account in the EU's decision -making process.  
4.198.   In the interest of efficient proceedings in both Committees and, in line with the respective 
Agreements, matters on approvals of active substances should be di scussed exclusively in the TBT 
Committee, while matters on the setting of MRLs for pesticides should be discussed exclusively in 
the SPS Committee. As regards the joint Request for the suspension of the processes and entry into 
force of reduction of Maximu m Residue Levels (MRLs) of plant protection products in light of the 
COVID -19 pandemic in documents G/SPS/GEN/1778  and G/TBT/GEN/296  and subsequent revisions, 
the EU has informed WTO Members of its position in the last three WTO/SPS Committees 
(respectively, on 25 -26 June 2020 - G/SPS/R/99 , 5-6 November 2020 – G/SPS/R/100  and 25 -26 
March 2021 – G/SPS/R/101) . In addition, the EU position is included in document 
G/SPS/GEN/1814/Rev .1 of 6 November 2020.  
4.1.3.18   European Union - Chlorothalonil (pesticide active substance) (ID 57943) 
4.199.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regarding the measure notified by the European Union in documen t 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, the regulation under 
which the marketing approval of the a ctive ingredient chlorothalonil is not renewed entered into 
force in May  2020.  This decision is already beginning to have implications and consequences for 
banana producers in Colombia and has repercussions for a broad chain of domestic agricultural 
produc tion. 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 level of detection, 
which will enter into force on 2  September  2021.  In this case, the EU has also faile d to take into 
consideration the technical comments submitted and the requests for a longer transition period to 
adapt production processes, which in the agricultural sector are particularly complex.  These decisions 
have been taken without the EU taking in to account the concerns raised by various members in this 
 
43 For previous stateme nts follow the thread under ID 579 . G/TBT/M/84  
 
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  Organization and in other settings, and without responding to the calls for dialogue made on a 
number of occasions.  We recall in particular that in document G/TBT/GEN/296/Rev.3 Colombia and 
a large group of Members request the EU to temporarily suspend review processes of market 
approvals for plant protection substances, and the entry into force of regulations in this area, planned 
for 2020, including the non -renewal of the active substance chlorotha lonil. This request was made 
in the context of the current health crisis, which has demanded the full attention of the health 
authorities, which do not have the capacity to deal with issues related to plant protection substances 
at this time.  
4.200.   As we have al ready 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 was the reduction of the MRLs to the minimum detectio n 
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.  These measures are being taken 
without any sound scientific evidence or proof th at they effectively constitute less trade -restrictive 
measures to ensure an appropriate level of protection for consumers.  The foregoing constitutes a 
violation of Article 2.2 of the TBT Agreement, which stipulates that technical regulations should 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 effec t on health or on the environment has 
not been clearly determined.  Any measures adopted must be based on scientific evidence and 
international standards and take account of the biodiverse agriculture of tropical countries such as 
Colombia.  In Colombia, the  use of plant protection substances – such as chlorothalonil – is essential 
in agricultural production for the protection of crops against pests and diseases, and for maintaining 
the quality and safety of products during storage, transport and distribution , before they reach 
consumers in the European market. Chlorothalonil is used in particular for banana crops, to control 
Black Sigatoka, a fungus that can devastate this crop.  
4.201.   The representative of Costa Rica  provided the following statement. Costa Rica once again 
fully supports the comments made by Colombia and reiterates its concern regarding the measure 
notified by the European Union in document G/TBT/N/EU/625 , relating to the non -renewal of the 
approval of the active substance chlorothalonil.  Costa Rica's concern has been expressed in previous 
meetings of this Committee and is based on the lack of conclusive scientific evidence and the 
application of a precautionary approach to 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 substance 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 tempo rarily suspend 
all review processes of marketing 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.  
4.202.   The represe ntative of Ecuador  provided the following statement. Ecuador wishes to reiterate 
its concern in relation to notification G/TBT/N/EU/625 on the non -renewal of the approval of the 
active substance chlorothalonil and document SANTE/10186/2018 Rev 1, through w hich the EU 
confirms the non -renewal of the approval of the substance.  Chlorothalonil is one of the main tools 
for controlling Black Sigatoka in bananas due to its effectiveness, low cost and multisite mode of 
action, meaning that the risk of resistance is  low. It is available in a wide range of products, through 
many suppliers, and is widely available in the country.  Controlling Black Sigatoka ( Mycosphaerella 
fijiensis ) 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 furt her complicate efforts to prevent pest 
resistance.  Our concern stems from the fact that the non -renewal of the approval of chlorothalonil 
also resulted in the notification of document G/SPS/N/EU/394/Add.1 dated 12  February  2021, 
pursuant to which new MRLs came into force for the active substances carbon tetrachloride, 
chlorothalonil, 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 affect banana production in Ecuador. 
Reducing the MRL for chlorothalonil could have a very significant economic impact on small -, G/TBT/M/84  
 
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  medium - and large -scale producers in Ecuador, as well as on cons umers in the EU, since the supply 
of our products would be affected.  Moreover, no substitute or similar phytosanitary products with 
the same environmental or toxicological profile are currently available, since the alternatives to 
chlorothalonil (mancozeb,  metiram) are already under review by the EU.  
4.203.   We ask that consideration be given to the fact that the banana 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. Ecuador is also focused on the implementation and certification of 
Good Agricultural Practices (GAP), having established a public standard for that purpo se, and these 
meet the same standards as international certifications such as GLOBAL GAP, since they are based 
on the following pillars: 1. Innocuousness : to deliver to the consumer a healthy, nutritious and 
innocuous product, without the risk that it woul d affect their health. 2. Worker health care : to 
safeguard and care for the health of farmworkers on the premises. 3. Environmental protection : to 
preserve and care for the natural resources of the agricultural production unit, beneficial insects, 
natural barriers within the farm, etc. 4. 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 definitive decision, as well as the broader entry into forc e 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 i nternational specialized agencies recognized by the WTO, such as the 
Codex Alimentarius, which has relevant information on this substance and, in the specific case of 
bananas, has established an MRL of 15 ppm. This statement is underpinned by the provision s of the 
WTO SPS Agreement, which stipulates that, when determining the appropriate level of sanitary or 
phytosanitary protection, Members should minimize negative trade effects and that sanitary and 
phytosanitary measures should be scientifically and tech nically justified, be based on risk 
assessment and not constitute unjustified barriers to trade.  Furthermore, Ecuador would like to ask 
the EU if, where emergency authorizations have been issued for the use of this substance, EU 
member countries have notif ied and justified the application of MRLs that differ from those 
established in the EU's existing MRL regulations. If so, which MRL is being applied by member 
countries and how is compliance with that MRL being monitored in intra -European trade?  
4.204.   The repres entative of Paraguay  provided the following statement. Paraguay refers to its 
previous statements. Like other Members, we remain concerned by the EU's decision to base 
measures on a hazard -based approach without a proper risk analysis and without  sound sci entific 
evidence , which results in the non -renewal of substances such as chlorothalonil and the subsequent 
reduction of their MRLs. This would cause significant damage to Paraguay's export sector since, as 
we demonstrated previously, this substance and oth ers are used as the main or complementary tool 
in fighting pests in Paraguay, which is a country with climatic conditions and thus pest -pressure 
levels that are very different to those of the EU.  Although we share the objectives that the EU seeks 
to achiev e with these policies, 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.  
4.205.   The representative of Brazil  provided the following statement. Brazil supports STC 579 and 
refers to its previous statements on the matter. We respectfully differ from the EU's decision to base 
measures on a hazard -based approach, without an adequate risk analysis and with no 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 re ach 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  
Brazilian 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.  
4.206.   The represent ative of Guatemala  provided the following statement. Guatemala maintains its 
position on this concern, especially because there is no information on scientific evidence of the 
possible damage to human health caused by consuming fruits and vegetables, parti cularly those 
produced in Latin America. We therefore reiterate the importance of conducting a risk analysis.  
Chlorothalonil is used in the production of bananas, snow peas, sugar snap peas, French beans and 
coffee; this active substance is used as a broad -spectrum and fast -acting contact fungicide. No other G/TBT/M/84  
 
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  molecule on the market is currently as effective for controlling the Ascochyta fungus, above all in 
vegetables. Guatemala 's climatic conditions provide this fungus with the ideal environment to 
reproduce, affecting crops and seriously harming Guatemalan producers and exporters and the 
economy.  Substances such as mancozeb, azoxystrobin, pyraclostrobin, sulphur and difenoconazole 
can be used to substitute chlorothalonil. The registration of four of  these alternative substances was 
not renewed for marketing in the European Union and, as a result, maximum residue levels have 
been reduced to almost zero tolerance, leaving Guatemalan agricultural production with no options 
that can effectively combat di seases of fungal origin.  
4.207.   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 gro wth 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, creating around 20,000 jobs. Guatemala' s banana exports account 
for 30% of total exports of traditional products from the customs territory. The banana is the world 's 
most consumed and exported fruit. Banana production has directly and indirectly created over 
280,000 jobs, and any changes to th e production cycle resulting from an increase in disease due to 
a lack of alternative substances would affect over 1,120,000 Guatemalans ( Asociación de 
Productores Independientes de Banano , APIB (Independent Banana Producers ' Association)).  
4.208.   We would there fore be grateful if the European Union would consider the particular 
circumstances of tropical countries when implementing the measures, until it has conclusive studies 
and has aligned itself with the provisions of the Codex Alimentarius. Accordingly, Guat emala requests 
it to: (i) consider the risk assessment approach and scientific evidence; (ii) set maximum residue 
levels (MRLs) that also correspond to the reality of tropical countries. These countries cannot be 
expected to have the same climatic conditio ns as European countries because it is just not feasible. 
We therefore request that the MRLs for chlorothalonil be reviewed, taking into account that no 
chemical substance on the market can replace chlorothalonil and effectively control the Ascochyta 
fungu s; and (iii) provide scientifically based information showing that vegetables and fruit exported 
from Guatemala or third countries are harmful to the health of European consumers.  
4.209.   The representative of Chile provided the following statement. Chile wishes t o echo the 
comments made by Costa Rica, Colombia and the delegations that took the floor before me. We 
would like to express our ongoing concern and will continue to follow up on this matter, especially 
given the impact that it will have on the agricultura l sector.  
4.210.   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 2019/67744, adopted on 29 April 2019 and previously notified to 
the TBT Committee. Chlorothalonil was evaluated in accordance with Regulation (EC) No 1107/2009 
on the placing of plant protection products on the market.45 The conclusion46 by the European Food 
Safety Authority (EF SA) 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 re levant limits of 
quantification through Regulation (EU) 2021/155 of 9 February 2021.47 The new values will apply to 
all food products as of 2 September 2021, since the Regulation provides for a transitional period of 
6 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. As regards the joint request for the suspension of the 
 
44 OJ L 114, 30.4.2019, p. 15.  
45 http://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107 . 
46 EFSA 2018 Conclusion on the peer review of the pesticide risk assessment of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126. https://www.efsa.europa.eu/en/efsajournal/pub/5126  . 
47 OJ L 46, 10.2.2021, p. 5.  G/TBT/M/84  
 
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  processes and entry into force of reduction of Maximum Residue Levels (MRLs) of plant protection 
products in light of the COVID -19 pandemic in documents G/SPS/GEN/1778  and G/TBT/GEN/296  
and subsequent revisions, the EU has informed W TO Members of its position in the last three 
WTO/SPS Committees (respectively, on 25 -26 June 2020 - G/SPS/R/99 , 5-6 November 2020 – 
G/SPS/R/100  and 25 -26 March 2021 – G/SPS/R/101) . In addition, the EU position is included in 
document G/SPS/GEN/1814/Rev.1  of 6 November 2020.  
4.1.3.19   Republic of Korea - Amendments to the Act on the Promotion of Saving and 
Recycling of Resources, G/TBT/N/KOR/843,  G/TBT/N/KOR/844,  G/TBT/N/KOR/857,  
G/TBT/KOR/918,  G/TBT/KOR/919,  G/TBT/KOR/937  (ID 58848) 
4.211.   The representative of Australia  provided the followin g statement. Australia recognizes the 
Republic of Korea's right to implement regulations that promote the reduction of waste and the 
production of easily recyclable packaging materials. Australia thanks Korea for providing an exclusion 
from displaying recy clability 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 glass, are not "difficult to recycle". A ustralia 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 environmental fee.  
4.212.   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 producers to place recycle -
friendly products on the market. Specifically concerning the draft notified under G/TBT/N/KOR/919 , 
please clarify to what the "standards " refer in Article 9 para.1(1). Additionally, please clarify if the 
"evaluation result document number " should also be indicated on the label. If so, please explain how 
this information would be relevant for consumers. The EU would also like to know why there are 
different entry into force dates for G/TBT/N/KOR/918  and G/TBT/N/KOR/919 . Regarding 
G/TBT/N/KOR/937 , the EU would appreciate receiving information about the exact scope of the 
notified draft, as well as on the justificat ion for the measure, especially since the "Act on the 
Promotion of Saving and Recycling of Resources " already defines packaging rules that companies 
have to follow and requires administrative authorities to regularly perform post -market audits on 
packaging  standards compliance. The new obligations appear to be quite burdensome and costly for 
the affected industries, and given the turnover of product portfolios, this may reduce product 
innovation. Hence, the EU would be grateful if the Korean authorities cou ld share information from 
any study or analysis that they have commissioned on this topic.  
4.213.   The EU also notes that there could be space issues to accommodate the required information 
on small products and would like to enquire if such products could be exem pted from the notified 
requirements. Additionally, there may be a business risk with potentially confidential product 
information, such as innovative product packaging, being disclosed to competitors during pre -launch 
inspections. Given the objective of re ducing waste and use of resources, the EU is of the view that 
the amendment should be implemented with enough transition time to avoid a massive change of 
the packaging of existing products, which could inadvertently cause a waste of materials and 
resource s. A differentiated approach would be needed between new products and products already 
placed on the market.  
4.214.   The representative of the United States  provided the following statement. As we noted at 
the last meeting, the United States recognizes the importa nce for Korea to work towards reducing 
waste and appreciates Korea's January 2021 notification of the draft partial amendment of the Act 
on the Promotion of Saving and Recycling of Resources ( G/TBT/N/KOR/937 ). We remain interested 
in responses to the questions raised at the Februar y Committee meeting. In particular, we welcome 
an update from Korea regarding the status of the amendment and any implementing guidance, the 
timeline for entry into force, and further information regarding grace periods upon entry into force. 
We would also  welcome a copy of the most recent version of the amendment and look forward to 
the opportunity to provide comments on any draft implementing guidance as soon as it becomes 
available. We also would ask that Korea, in developing new and proposed amendments to the Act, 
not lose sight of the potential for some materials to be recycled via exports rather than in Korea. 
The packaging criteria and labelling should allow for packaging classifications to be updated based 
on new recycling technologies, which are adv ancing rapidly. In its response to US industry comments 
 
48 For previous statements follow the thread under ID 588 . G/TBT/M/84  
 
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  on G/TBT/N/KOR/918  and G/TBT/N/KOR/919 , the Ministry of Environment (MOE) suggests that 
"simplified methods " such as QR codes may be allowed for more flexibility for small -capacity 
products. Does MOE intend to release implementing guidance? We appreciate the opportunity to 
provide comments on any draft implementing guidance as soon as it becomes available.  
4.215.   We un derstand that the implementation date in G/TBT/N/KOR/918  was six months after the 
date 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 additional labelling, and we urge a reasonable timeline to allow producers to adapt. Is 
there an update on the timeline for adoption and implementation of G/TBT/N/KOR/937?  MOE states 
in its 29 December 2020 response to US indust ry comments, "Newly released products will be given 
a one -year grace period… and existing products will be flexibly applied with a three -year grace period 
after the revision. " When will that three -year grace period begin? How does MOE define "newly " in 
"newly released products "? What does "flexibly applied " mean? Will all existing 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 administrative costs. MOE's 
response to US indu stry 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 advance ". 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 stat ed objective?  
4.216.   The representative of Chile provided the following statement. Chile, as indicated at previous 
meetings of this Committee, recognizes the right of the Republic of Korea to implement regulations 
that promote waste reduction and the production o f easily recyclable packaging materials. The 
Chilean Ministry of the Environment 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, is what this measure 
will create.  
4.217.   The representative of New Zealand  provided the following statement. New Zealand supports 
measures that focus on legitimate objectives, including those tha t produce positive environmental 
outcomes, such as encouraging recycling and reducing 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 structu re and recyclability of packing materials. New Zealand would 
appreciate clarification 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 important 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.  
4.218.   The representative of Mexico  provided the following statement. Mexico wishes to reiterate 
its concern with regard to the amendments to the implementing regulations of the Act on the 
Promotion of Saving and Recycling of Resources, notified by Kor ea. The doubts and comments 
expressed during the February meeting remain. Thus, in the interest of time, we request Korea to:  
provide clarification on the procedure to be followed to request the exemption of certain products 
from this requirement, which in  this particular case, would be an exemption for tequila; and  share 
the most recent information on the date of entry into force envisaged and the latest version of the 
measure, preferably in English.  We thank Korea for its replies, which we will examine in  detail.  
4.219.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea appreciates the interest of the Members in Korea's Act on the Promotion of Saving and 
Recycling of Resources. Korea would like to deliver the officia l response from the regulatory 
authority. Wine bottles, in accordance with the Subparagraph 3(B) of Article 5 of the Packaging 
Materials/Structure Grade Display Standards (Ministry of Environment Notice No. 2020 -39), are 
packaging materials that are recogn ized as the items to be exempt from labelling duty due to 
concerns about product malfunctions when the packaging material or structure is changed. Korea 
would like to clarify that the recycling contribution (environmental) fee will be paid according to the  G/TBT/M/84  
 
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  recycling obligation of manufacturers or importers, regardless of whether or not the labelling 
obligation is exempt. Therefore, wine importers are not required to mark the recyclability grades on 
their wine bottles, but they are required to pay the recycl ing contribution fee based on their duty to 
facilitate recycling, with additional charges when their bottles are graded "Difficult to Recycle". Korea 
will proceed subordinate statutes legislation for labelling guideline regarding labelling method such 
as exemption from labelling obligation for small sized products and QR code application, and notify 
the TBT Committee so as to allow for  comments when the legislation is adopted. Korea will allow  
self-test to check packing regulation compliance according to the guideline by Ministry of 
Environment as well as the inspection by certified test agencies designated by MOE, which will settle 
the matters such as product launch delay, higher cost and info rmation leaks that you are concerning. 
It is planned to grant one  year of grace period to newly released products and three -year grace 
period to existing products considering the adaptation period of concerned business when the 
legislation is adopted. Kore a has reviewed the comments regarding notificatio ns G/TBT/N/KOR/918 , 
G/TBT/N/KOR/919  and G/TBT/N/KOR/937  from the WTO Members, and we are discussing legislation 
amendment with the National Assembly to implement and settle the legislation regarding the pre -
test and labelling of packaging. We will notify TBT the revised legislation ag ain when the legislation 
is confirmed.  
4.1.3.20   China - Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522 , G/SPS/N/CHN/1191  (ID 61149) 
4.220.   The representative of Australia  provided the following statement. Australia recognizes the 
right of governments to take mea sures necessary to protect public health, including food safety and 
hygiene measures. However, we remain concerned that aspects of China's "Decree 248 Regulation 
of the People's Republic of China on the Registration and Administration of Overseas Producers  of 
Imported Food" (notified in G/TBT/N/CHN/1522 ) are more trade -restrictive than necessary to fulfill 
China's food safety objectives. Australia  thanks China for  its reply to  Australia's comments  to TBT 
notification G/TBT/N/CHN/1522 . Whilst we appreciate the response received, it did not completely 
address Australia's concerns. Australia would still like to understand the specific food safety health 
concern that China seeks to address through this Regulation  and China's Food Safety Law as well as 
the scientific justification for its application across al l foods regardless of their food safety risk. 
Australia would like to again request that 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 different 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 restric tive than necessary. 
We would also be grateful for China to advise how Australia's and other Members' comments on its 
notification have been taken into account in finalising the regulation as Decree 248. Australia will 
carefully consider China's response t o Australia's comments in detail and provide further written 
comments to China regarding our remaining concerns.  
4.221.   Australia requests that China implement this Regulation in a risk -based and proportionate 
manner that minimises the regulatory burden on China and other WTO Members, in accordance with 
China's WTO obligations. It is unclear if the new registration requirements are intended to apply 
equally to foreign food facilities and China -based facilities that manufacture for China's domestic 
market. Australi a reminds China that its regulations must not be used to discriminate against 
imported goods and must be WTO -consistent. We are concerned that the Regulation 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. Requiring foreign 
food facility registration for all imported foods does not accord with a food safety risk -based approach 
to managing imported food. Australia does not c onsider this measure to be appropriate, 
proportionate or necessary for low risk foods. For example, Australia considers that highly processed 
shelf-stable foods and food storage facilities should be exempt from registration requirements, given 
their low fo od safety risk. The Regulation specifies that China must first consider the food safety 
management system of the exporting country as equivalent to China's before accepting any 
applications for registration of facilities. This would be a significant admini strative burden for both 
China and the exporting country. Where China does recognize  another WTO Member's national food 
control system as equivalent, it would be duplicative and unnecessary to also require individual food 
facilities to provide commercial d ocumentation and inspection and audit reports. Conversely, where 
food facilities are already being individually registered with China, it would seem excessive and 
 
49 For previous statements follow the thread under ID 611 . G/TBT/M/84  
 
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  trade -restrictive to also require recognition of food safety system equivalence. Australia ag ain 
requests that China reconsider these additional administrative requirements.  
4.222.   Given the short timeframe leading up to the date of implementation on 1 January 2022, 
Australia asks that China publish any draft implementation procedures or regulations as s oon as 
possible to enable other WTO Members to comment on the drafts, to take those comments into 
account and to allow businesses sufficient time to adjust to any new measures – thus ensuring 
minimal disruption to trade. We note that China has indicated it  will provide a transition period before 
entry into force of Decree 248. Given the significance of the new measures outlined in Decree 248, 
Australia requests that China consider extending the implementation date to at least 1 July 2022 to 
allow time for W TO Members and food facilities to make arrangements to meet China's requirements. 
Australia has an established and successful history of trade in food products with China and seeks 
to continue this strong bilateral trading relationship. We would welcome an  opportunity to engage 
with the competent authority of China to meet the objectives of the proposed measures while 
safeguarding trade.  
4.223.   The representative of the United States  provided the following statement. The United States 
notes that China has publishe d the final version of this measure as Decree 248 on 12 April 2021, 
with an implementation date of 1 January 2022. We remain concerned with such a trade -restrictive 
regulation, which does not have clear food safety and public health benefits. The measure a ppears 
to apply to all food products, regardless of risk or whether foods are already subject to additional 
import certification requirements. We anticipate that the measure, when implemented, will likely 
create major trade disruptions for the United State s and every country that exports food and 
agricultural products to China. The United States urges China to reconsider implementation of this 
measure. We suggest that China utilize a risk -based approach to determine which procedures may 
be required for indi vidual product groups to meet China's appropriate level of consumer protection. 
We request that China identify and explain which food safety risks its procedures will mitigate that 
are not already addressed by China's prior legislation. Furthermore, any me asure of this magnitude 
requires far more than nine months to be implemented. Given these various concerns, we ask that 
China suspend or delay implementation of these measures. This measure appears to overlap with 
other similar measures, notably Decree 177  on the import/export of grain, and the "Administrative 
Measures on Import and Export Food Safety " notified to the WTO SPS Committee as 
G/SPS/N/CHN/1191 , and recently published by China as Decree 249. How does Decree 248 relate 
to these other measures?  
4.224.   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 notifying the draft regulation on Re gistration and Administration 
of Overseas Manufacturers of Imported Food ( G/TBT/N/CHN/1522  on 16 November 2020). As this 
proposed measure will be affecting a wide range of our food -related industry, we expressed our 
concerns at the previous TBT Committee Meeting on 24 -26 February  2021. In addition, detailed 
comments were sent to seek confirmation and clarification on 6 April 2021. Up to this date, we have 
not received response from China. We remain concerned with the significant impact of this measure 
and would appreciate an updat e on the status of the measure. We look forward to receiving a written 
response to our comments and further information on the future implementation of the measure.  
4.225.   The representative of the European Union  provided the following statement. The EU has 
been following the development and consolidation of these measures carefully and commented on 
draft texts before and after they were notified to WTO under G/TBT/N/CHN/1522  and 
G/SPS/N/CHN/1191 . The EU finds it regrettable that Decrees 248 and 249 were publis hed by the 
General Administration of Customs of the People's Republic of China (GACC) without consideration 
of our comments or any reaction. China and the EU trade high volumes of food products and 
beverages through tens of thousands of enterprises, some b ig, many small. While the EU shares 
China's commitment to ensuring the safety and legality of trade, the administration of business 
registrations should support trade and avoid cumbersome procedures, where possible. Clear 
guidance, standardized template fo rms and realistic transition periods are indispensable in order to 
minimize disruptions to economic relationships between enterprises on both sides. Accordingly, the 
EU urges GACC to: develop detailed guidelines, implementing rules and template forms in 
cooperation with stakeholders and notify these elements through WTO channels for comment; 
clearly define the product categories by their HS numbers that must register under the "registration 
with recommendation" procedure under Article 7 of Decree 248; defin e the types of operations that 
must register. It is the EU's understanding that the exporter of consumer products must register, G/TBT/M/84  
 
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  i.e., the entity that is liable for guaranteeing conformity of the product with food safety standards; 
it is also our understan ding that products shipped in bulk from business to business – such as dairy 
powders – are not required to register; provide for realistic and practicable implementation and 
transition periods of at least 18 months after detailed guidance is available. Ent erprises that are 
already registered and listed by GACC today should be exempt from the immediate implementation 
of the measures. For example, enterprises approved in 2018 should remain approved for five years; 
ensure that once registrations are approved a nd registration numbers are allocated, provisions 
related to labelling under Article 15 be implemented with adequate transition periods. In particular, 
products with a long shelf life, such as spirits, may be in retail stocks for many months and must be 
protected by transition periods of at least 36 months.  
4.226.   The representative of the Philippines  provided the following statement. The Philippines refers 
to China's proposed "Administrative Measures for Registration of Overseas Producers of Imported 
Foods" (Decr ee 248). In this regard, we have submitted comments and asked clarifications to China, 
first on 2 February 2021, and then again on 11 May 2021 because China had neither acknowledged 
receipt of those comments and questions, nor replied to them. We look forw ard to receiving China's 
response to the comments and clarifications submitted through its enquiry point. Our request is one 
of bare, minimum transparency so that we can understand the rationale and assess better the 
relevant procedures foreseen in the pro posed measure. The Philippines joins other WTO Members in 
asking China to abide by the clear rules of the TBT Agreement and ensure that its regulations do not 
create unnecessary obstacles to trade and are not more trade -restrictive than necessary to fulfil l its 
legitimate objectives. We respect China's right to regulate in order to ensure food safety. Every WTO 
Member has that right, but every WTO Member, including China, must also abide by its obligations 
in the TBT and other applicable WTO agreements. The  Philippines thus asks China to explain the 
health and safety objectives that China seeks to achieve through the proposed measure. Does it 
take into account Codex risk analysis principles? Would such Codex guidance not achieve the 
objectives that China see ks? What are the scientific underpinnings of the comprehensive registration 
system that China is proposing?  
4.227.   We would also like to be assured that the proposed measure is intended to be enforced in 
an even -handed manner on both imports and domestic food pro ducers. Non -discrimination is a core 
obligation in the WTO. The proposed measure must not be a disguised means to protect the domestic 
industry. The proposed measure will have a negative impact on food trade between China and other 
WTO Members. The product  scope is comprehensive, and the additional administrative requirements 
will certainly be a burden on all exporters as well as on the competent authorities. Furthermore, the 
competent authority can have capacity constraints, as it will be in our case. The proposed mandatory 
registration will require our competent authority to vouch for all food exporters through a registration 
system envisioned by China, and yet its own General Administration of Customs of China, or GACC, 
as we understand, will undertake th e same process again. It is, thus, duplicative and costly. The 
inefficiency is amplified if the required registration is on top of current arrangements in existing 
bilateral agreements that have worked well.  
4.228.   The Philippines' representation to the WTO in C hina coordinates with our commercial 
representations around the world. Our trade promotion offices in China informed us about the China 
International Import Exposition (or CIIE) and requested that the following statement be made at 
this meeting. The Philip pines has been actively promoting trade for food products at the Philippine 
Pavilion at the China International Import Exposition (CIIE) in Shanghai, ever since its inaugural 
edition in 2018. As we were made to understand, the CIIE's primary objective was to lend credence 
to China's announcement that it is ready to open its market to the world and be a pillar in economic 
cooperation. In fact, it is the only exposition in the world that is an "import" exposition, where 
Chinese companies are not allowed to jo in as exhibitors. The government in China has fully 
supported and promoted the CIIE, stating that China's imports will exceed USD 5 trillion in the 
coming years, and that as China's new economic strategy promotes the so called "dual circulation " 
model, the  building up of a powerful, consumption -driven domestic market will open opportunities 
further for trade and investments. The CIIE has helped tremendously in boosting food exports and 
tapping China's mainstream markets. In 2020, our booked orders for food alone at the CIIE, despite 
the pandemic, was close to half a billion US dollars. The hope is that the proposed changes due to 
China's announcement of Administrative Measures for Registration of Overseas Producers of 
Imported Foods will not nullify the gain s made in international trade cooperation initiated by China 
itself through major projects such as the CIIE.  G/TBT/M/84  
 
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  4.229.   The representative of Mexico  provided the following statement. The Mexican Government 
reiterates the concerns raised during the February meeting, w hich refer to the lack of clarity with 
respect to the products covered by the measure, additional administrative procedures for the 
competent authority of the country of origin, as well as information on the risk analysis that will 
determine the method of application for registration and documentation to be requested from each 
enterprise.  In light of the above, the Mexican delegation once again kindly requests the delegation 
of China to:  clarify the scope of the products covered by the Regulation, and confi rm whether 
alcoholic beverages are included in this list of products;  explain how the measures contained in the 
Regulation are effective and proportionate in terms of meeting China's legitimate food safety 
objective;  share technical and scientific informat ion, as well as international standards that form the 
basis for the development of this Regulation.  The delegation of Mexico thanks the delegation of 
China for giving its consideration to this statement and the requests made therein.  
4.230.   The representative of Japan  provided the following statement. It is highly regrettable that 
the regulations have been published without any responses from China to Japan's comments on TBT 
notification, G/TBT/N/CHN/1522 . We are seriously concerned that the regulation would impose 
additional burdens on overseas manufacturing, processing and storage facilities and foreign 
competent authorities, and the implementation of the regulations would create unnecessary trade 
barriers and negative impact on food trade between China and WTO Members. Japan would like  to 
underline the four points of our concerns at present. Firstly, the scope is specified in product name 
but not in HS code, so what food items would be affected by the new regulations have not been 
clarified. For example, soy sauce is mainly used as seas oning but it does not fall into China's HS 
code of "seasoning ", 2103909000. We do not know whether soy sauce is subject to the regulation 
or not. Japan requests China to specify not only the product name but also the HS codes of the 
affected products. In a ddition, "foodstuffs " stated in Article 9 should be also specified in HS code. 
Secondly, the scope of overseas manufacturing, processing and storage companies subject to the 
registration of Article 2 is not clearly defined. Japan would like China to clearl y state which business 
categories defined in the Chinese Food Safety law will be subject to the registration. Thirdly, 
according to the China's response to the Japan's comments, Japan understands that registration of 
the overseas manufacturers that have be en registered before the publication and implementation of 
the Administrative Regulations will be valid after the implementation during their validity period. 
However the expiration date of the registration of manufactures is not clear. The validity period  
should be clarified.  
4.231.   Finally, it is published that the regulations will be enforced on 1 January 2022, but there is 
no information on the specific procedures and timeline of the registration of business operators, such 
as when the competent authorities of  foreign countries should submit the list of business operators 
to China, and when China will complete registration of business operators in the submitted list and 
provide the registered numbers, when China will publish the name of the registered company a nd 
the registration number on the official website. Without such basic information, it is difficult for 
foreign competent authorities to establish domestic system and prepare to comply with the 
regulations. In order that the regulations do not make a negat ive impact on the trades between 
China and WTO Members, we would like China to take into consideration the comments and concerns 
from the WTO Members and reconsider the implementation date of the regulations. Japan would like 
to request China to provide su fficient transition period after providing WTO Members with necessary 
information on the regulation.  
4.232.   The representative of Brazil  provided the following statement. Brazil appreciates the public 
consultation notified under G/TBT/N/CHN/1522 . In this new draft regulation, we value t he further 
detailing of the scope 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 facil ities. 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 s till believe said regulation might 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 
Chinese 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. The new measure 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 -restrictiv e than G/TBT/M/84  
 
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  necessary and they pose a great burden on producers and on the competent authorities of the 
exporting countries, without clearly demonstrating the gains in terms of food safety and health 
promotion. We kindly urge China to consider less trade -restrictive alternatives that could properly 
address its legitimate concerns.  
4.233.   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 said standard. Brazil kindly asks China to clarify how registration for the importation of 
high-risk products will take place, including whether ot her requirements such as annual reports or 
inspections will be demanded. We urge China to provide reasonable transitional periods for said 
products and to allow for the possibility of adequate adjustment to its new regulation. We also ask 
China to further detail any information related to inspections and annual reports. 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 ba sis for outsourcing 
inspection responsibility to the competent national authorities. Finally, could China commit to also 
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?  
4.234.   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 the proposed measure continues to include 
all food categories irrespective of their risk profile an d 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 statements for more detailed comments. Switzerland encourages China to consider 
other ways and mea ns to ensure the importation of safe food products. We stand ready to engage 
with China on this matter and seek more clarifications with regard to the product categories (by 
their HS codes) and the types of operations that will need to be registered. Switz erland invites China 
to foresee realistic and practicable implementation and transition periods as well as to adopt more 
detailed guidelines, implementing rules and template forms.  
4.235.   The representative of the Republic of Korea  provided the following statemen t. Korea shares 
the concerns raised by the delegations of Australia, the EU, the United States, Chinese Taipei, the 
Philippines, Mexico, Japan and Brazil regarding China's "Administrative Measures for Registration of 
Overseas Producers of Imported Foods " (in short, the Administrative Measures). Korea believes the 
objective of promoting food safety is well reflected in the Administrative Measures. However, the 
Measures , which China has promulgated on 12 April 2021, still include the provisions of the Draft 
Measures notified in 2019, on which Korea and other countries have raised concerns. Therefore, 
Korea would like to once again ask China to address the following concerns on the Measures. (i) We 
ask China to provide scientific evidence that underpins its dec ision to expand the scope of products 
subject to preliminary review and registration recommendation of the exporting country's 
government, to include agricultural foods, special dietary foods, dietary supplements and 
condiments. Such requirement would impo se a significant administrative burden and incur excessive 
time and cost on both importing and exporting authorities, resulting in unnecessary barrier to trade. 
Korea therefore calls on China to revise the scope and allow processed food products, which are  
lower in risks, to be registered via document review . (ii) According  to the Administrative Measures, 
exporting competent authorities are required to report to the Chinese government and suspend 
export if hazards associated with food safety are found in fo od products. This measure would place 
an undue burden on governments of exporting countries, which merits more reflection in the 
implementation. 3) Last but not least, it is imperative that China clarify the relevant guidelines such 
as those on competent a uthorities' evaluation standards on exporters' food safety management 
system as well as on the interval of GACC's foreign manufacturer registration. Korea also calls on 
China to allow reasonable time for businesses to adapt to the new Regulation ( G/TBT/N/CHN/1522 ) 
under Ar ticle 2.12 of the TBT Agreement. Korea looks forward to China's feedback on the comments 
and concerns of Korea and other Members, and reconsideration of the above -mentioned provisions 
in the Measures.  
4.236.   The representative of Canada  provided the following sta tement. Canada would like to thank 
all the Members raising this specific trade concern regarding China's administrative measures for 
registration of overseas manufacturers of imported food. While Canada welcomes and appreciates 
the information provided by China on 24 May 2021 in response to comments submitted in January G/TBT/M/84  
 
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  2021, further clarifications are still needed on a number of elements contained in the draft 
regulations. This information is necessary to ensure that industry stakeholders and foreign 
compe tent authorities understand and are able to comply with the requirements. As such, Canada 
remains concerned that the administrative measures being implemented by China are overly 
burdensome and unjustified as they go beyond the extent necessary to protect against food safety 
risks. The new measures under Decree 248, which outline additional oversight, establishment and 
product registration requirements, appear to be more trade restrictive  than necessary by creating 
unnecessary administrative delays which co uld impact resources throughout the supply chain. In 
Canada's view, if these measures are implemented as they are currently published, they will 
negatively impact trade and restrict food exports to China. We strongly encourage China to have 
open and transp arent discussions with trading partners to further clarify the requirements under the 
new Decree and consider the impact the new measures may have on trade prior to its 
implementation. To further minimize any disruptions to trade, Canada would invite China  to provide 
trading partners with information on measures, including those that are currently in place or under 
development, that are put in place by China to strengthening registration and supervision in a timely 
manner to avoid any trade disruption. Give n 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. In 
light of  these concerns, Canada respectfully requests that China delays implementation of the new 
measures for 18 months to provide a reasonable timeframe for trading partners to adjust and avoid 
unnecessary trade disruptions. Finally, Canada notes that our techni cal experts remain available to 
pursue further discussions on this issue in a bilateral setting.  
4.237.   In response, the representative of China  provided the following statement.  It is a clear 
requirement of the Food Safety Law of the People's Republic of China to improve further the 
administration of overseas manufacturers of imported food. Regulations of the People's Republic of 
China on the Registration and Administration of Overseas Manufactures of Imported Food was 
published on 12 April 2021, and will come i nto force on 1 January 2022. This regulation optimizes 
the registration procedures, clarifies the duties of overseas manufactures and regulators, and 
improves the operation of the regulation with more relevant details, so as to facilitate the 
registration.  It is noted that this regulation will not affect the implementation of the agreements 
which have already been signed with other Members by Chinese authorities, and will promote the 
stable trade development. On 16 November 2020, China notified the WTO the revised draft of 
Regulations ( G/TBT/N/CHN/1522 ) and gave 60 days commenting period for Members. China has 
also given written replies to the comments from EU, USA, Canada, Philippines, Japan, Korea and 
Australia.  
4.1.3.21   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA (ID 61850) 
4.238.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
thank Peru for keeping it informed about progress made in the process to implement the draft 
Regulation established under Supreme Decree No. 015 -2019-SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018-SA. As we have previously stated, 
under the proposed amendment to the Manual of Advertising Warnings, the use  of stickers or 
adhesive labels to meet the Manual 's labelling requirements will no longer be permitted in Peru as 
of June 2020. Peru recently informed us that the entry into force of this Regulation had been 
postponed until 30 March 2022.  Although this po stponement 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 Central America.  The food industry has informed 
us about 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 such 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 St andard for the Labelling of Prepackaged Foods, permit the use of 
supplementary or adhesive labels, as long as it is guaranteed that they will not become separated 
from the container, or in cases where the language on the original label is not acceptable to  the 
consumer for whom it is intended.  
 
50 For previous stateme nts follow the thread under ID 618 . G/TBT/M/84  
 
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  4.239.   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 pro vides the required level of protection, but also makes it easier for 
exporters to comply with non -harmonized international requirements.  At the national level, 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 sou ght. We therefore ask for reciprocity 
of treatment.  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 m eet labelling requirements, given that this is an appropriate means for the 
fulfillment 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 fulfill the proposed legitimate objectives, 
in accordance with the obligations regarding technical barriers to trade established in the relevant 
World Trade Organization Agreement an d 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 econom ic recovery.  In view of the above, we respectfully 
restate Costa Rica 's wish that the Peruvian authorities remove the proposal to prohibit the use of 
stickers and maintain the possibility of permitting their permanent use.  
4.240.   The representative of the Europea n 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). However, the EU importers are increasingly concerned because this deadline is 
now quickly approaching. EU recognize that reliable information to the Peruvian consumer is a 
legitimate objective. Nevertheless, the obligation to print information on the product package before 
the product is shipped to Peru is trade restrictive and represents  a disproportionate burden for 
foreign producers, in particular SMEs. 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 removable. The EU would like to repeat the urgent invitation to Peru to provide for a 
permanent possibility to use stickers. We are committed to working with Peru bilaterally on this  
issue.  
4.241.   The representative of Colombia  provided the following statement. Colombia would like to 
reiterate its concern regarding the Manual of Advertising Warnings prepared in accordance with the 
implementing regulations to Law No.  30021 on the promotion of  healthy eating among children and 
adolescents, which was issued through Supreme Decree No.  021-2020-MINSA of 12  June 2020 and 
notified in document G/TBT/N/PER/97/Add.2.  Under these regulations, the deadline was set for to 
30 June 2021 for the use of adhes ive advertising warning labels that was provided for in paragraph 
8.3 of Supreme Decree No.  012-2018 on 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 the Law on Healthy Eating, given that the warnings presented through stickers 
will continue to be clear, legible, prominent and com prehensible, 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.  Such a specific technical measure on 
labelling const itutes a barrier to trade, particularly for small and medium -sized enterprises. It should 
be recalled that most Colombian exporters to Peru are enterprises whose economies of scale and 
volumes of trade do not warrant the increased expense of developing spe cial packaging for trade 
with one country in particular.  
4.242.   Furthermore, this type of measure runs counter to international labelling practice and the 
Codex Alimentarius approach, such as Article 8 on Presentation of Mandatory Information, General 
Standard fo r 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.  We 
welcome the bilateral talks that have taken place at different levels, a nd the progress reported. We 
request further information from the Peruvian authorities on the status of these regulations, taking 
into consideration that the deadline for the use of stickers is drawing near. Colombia once again G/TBT/M/84  
 
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  requests Peru to agree to th e application of the rule allowing the indefinite use of adhesive labels or 
stickers with warning icons and messages on food packaging.  
4.243.   The representative of Brazil  provided the following statement. Brazil regrets having 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). 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 goods, Articles 8.1.1 and 8.2.1, explicitly allows for 
the possibility of using additional labels or stickers, as l ong as they are attached to the packaging 
and if the language of the original label is not necessarily that of the consumer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that he lp better inform consumers. Despite Peruvian legitimate concerns with deceptive 
practices, advances in labelling technologies allow for their safe affixation. We acknowledge that, 
according to Supreme Decree 021 -2020-SA, the entry into force of the prohibi tion on stickers was 
delayed until 30 June 2021. However, Brazil would like to respectfully ask Peru to permanently align 
its labelling requirements with current international standards established under the Codex and 
withdraw the prohibition of stickers f or 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 until Peru permanently removes its burdensome requirements for food labelling.  
4.244.   The represen tative of Guatemala  provided the following statement. We reiterate the 
recognition of Peru's right to protect people 's health and to provide consumer information on foods.  
In accordance with the Agreement on Technical Barriers to Trade, relevant internatio nal standards 
where they exist will be used to avoid unnecessary obstacles to international trade. As raised in 
previous meetings, CODEX CXS 1 -1985, General Standard for the Labelling of Pre -packaged Foods, 
states that a supplementary label may be used on imported products that do not comply with 
Peruvian regulations, which must accurately reflect the information on the original label. Peru is 
again requested to reconsider the use of a supplementary label, given that its use is widely 
recognized internation ally, as it fulfills the same public health protection and consumer information 
purposes.  Regarding the points made to Peru at previous meetings on Supreme Decree No. 015 -
2019-SA, Guatemala's position remains the same.  
4.245.   The representative of Paraguay  provid ed the following statement. Paraguay has received 
comments from its industries through the Chamber of Paraguayan Food Businesses, which highlight 
the negative effects that could be generated by the limitations on the use of supplementary labels 
to be adopt ed by this measure. As other Members pointed out at the previous meeting, the use of 
supplementary labels is widely recognized at the international level and is a valid option for industries 
to adjust to the specific requirements of different markets, bear ing in mind the main objective of 
these labels, which is to provide consumers with clear information and meet regulators' 
requirements.  Paraguay supports Peru's objective of protecting public health and considers that the 
provision of information to consum ers through the label is an appropriate strategy. However, we 
share and support the concerns expressed by other Members with regard to the time limit 
established for the use of supplementary labels, since this may be more trade -restrictive than 
necessary, and we therefore urge Peru to reconsider this measure and bear in mind the provisions 
of Article 2.2 of the TBT Agreement, which specify: "Members shall ensure that technical regulations 
are not prepared, adopted or applied with a view to or with the effec t of creating unnecessary 
obstacles to international trade. For this purpose, technical regulations shall not be more trade -
restrictive than necessary to fulfill a legitimate objective, taking account of the risks non -fulfillment 
would create. Such legitim ate objectives are, inter alia : national security requirements; the 
prevention 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 processing technology or intended end -uses of 
products."  We thank Peru for the information received regarding a further extension of the grace 
period and while we appreciate this decisio n, it shall not solve the underlying problems that our 
exporters will face. We therefore request that Peru review this measure.  
4.246.   In response, the representative of Peru provided the following statement. As we have done 
in previous meetings, Peru wishes to r eiterate that it is committed to its work to protect the health 
of its citizens and vulnerable groups, such as children and adolescents, through public policies aimed 
at achieving this goal, in accordance with the country's international trade commitments in this 
domain.  In this connection, Peru is seeking to ensure that the information contained in the Manual G/TBT/M/84  
 
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  of Advertising Warnings (MAP) reaches consumers clearly and effectively, so that they can make 
informed choices. As has been pointed out, Peru, by me ans of Supreme Decree No.  021-2020-SA, 
extended the period during which the use of adhesive advertising warning labels, provided for in 
paragraph 8.3 of section  8 of Supreme Decree No. 012 -2018-SA approving the MAP under Law No. 
30021 on the promotion of h ealthy eating among children and adolescents, is permitted until 30 
June 2021. However, in the light of the concerns expressed by some Members, Peru is currently 
making the relevant final arrangements in order to further extend the period during which the use 
of adhesive labels is permitted.  Lastly, we reiterate that Peru wishes to honour its WTO commitments 
and therefore reaffirms its commitment to not preparing, adopting or applying technical regulations 
that may create unnecessary barriers to trade, as e stablished in the Agreement on Technical Barriers 
to Trade.  
4.1.3.22   European Union - Non-renewal of the approval of the active substance mancozeb 
(ID 62751) 
4.247.   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 of 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 subsequent reduction of their MRLs to the minimum level 
of detection, are being taken without str ong scientific evidence and without demonstrating that they 
are indeed the least trade -restrictive measures to achieve an appropriate level of protection.  We 
have already referred to the importance of this substance in plant protection on previous occasion s. 
On this occasion, we would like to ask the EU to provide clarification on the relationship between the 
notification in document G/TBT/N/EU/712 on mancozeb and the notification in document 
G/TBT/N/EU/797 regarding the REACH regulation, with respect to ca rcinogenic, mutagenic and toxic 
for reproduction substances.  We would also like to recall that, even though in this and various other 
cases we have requested the EU to provide information on the deadline for adoption of the standard 
and on the implementati on of maximum residue limits, the EU has failed to respond to these 
requests.  
4.248.   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 into fo rce 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".  The information available indicates that 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 appropriate sta ge and take into account 
Members' comments, in line with Article 2.9.  Lastly, 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 d ialogue with stakeholders, transparency and the 
minimizing of market distortions.  
4.249.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concern raised by Paraguay, Brazil, Australia 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 that Members have the right to determine 
the appropriate level of sanitary or  phytosanitary protection needed to protect human, animal and 
plant life or health, and to establish measures to that end. In turn, may we remind Members that 
these measures must be science -based and should not create unnecessary barriers to trade, 
especia lly 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 t han 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.   
 
51 For previous statements follow the thread under ID 627 . G/TBT/M/84  
 
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  4.250.   Costa Rica is the world 's second larg est 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 maximum residue levels ( 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 will 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 reason able period of 
time to respond to the numerous challenges posed by the COVID -19 pandemic and find a alternative 
substance so that Costa Rican farmers can continue to grow bananas and export the volumes 
required to meet the EU market demand.  
4.251.   The representat ive of Australia  provided the following statement. Australia recognizes the 
European Union (EU)'s right to regulate the manufacture and use of plant protection products in 
agriculture to address risks unique to its settings. However, Australia reiterates i ts concerns about 
the proposed non -renewal of mancozeb and the potential impact on Maximum Residues Limits 
(MRLs) and effects this may have on trade, including wine exports to the EU. Australia seeks 
clarification on the risks to consumers from mancozeb re sidues on produce, especially wine, and 
how these will be taken in consideration in the revision of MRLs. Australia would also appreciate 
clarification on the timeframe for the conclusion of this revision. Australia notes that the EU has 
recently made seve ral plant protection products non -renewal decisions and subsequent changes to 
relevant MRLs which are impacting Australia's trade with Europe. Australia also notes that our 
competent domestic authority (Australian Pesticides and Veterinary Medicines Author ity) and Codex 
have determined MRLs for dithiocarbamates that ensure the continued protection of human, animal 
and environmental health while allowing trade to continue.  
4.252.   The representative of Paraguay  provided the following statement. Paraguay refers to it s past 
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 conclusive scientific evidence , 
which resulted in the reduction of the MRL for and the non -renewal of mancozeb. The loss of 
mancozeb as a plant protection tool would cause significant damage to Paraguay's export sector.  As 
we have stated, 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, which is a 
country with climatic conditions and thus pest -pressure levels that are very different to those of the 
EU. Although we share the objectives that the EU seeks to achieve with these policies, we  do not 
agree with the method used to achieve them, as it is not based on scientific evidence. We urge the 
EU to consider less trade -restrictive alternatives and base its measures on conclusive scientific 
evidence.  
4.253.   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. 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 
will si gnificantly impact the income of Brazilian farmers. 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 chlorot halonil. Mancozeb is an 
important tool for the management of fungicide resistance to control soybean rust, one of the most 
devastating diseases for this crop. It is used as a crop protection additive, intended to increase the 
effectiveness of other fungici des, minimizing resistance and prolonging the life cycle of other 
molecules, which would otherwise have an extremely short life cycle. Also, such crops cannot have 
their treatments changed in time for exportation to the EU market before late 2020. We also urge 
European authorities to consider establishing transition periods that are adequate to the production 
cycle of the affected crops. Once again, Brazil respectfully asks the EU to align MRLs with limits 
established under the framework of Codex Alimentari us and to less trade -restrictive alternatives that 
would also safeguard its legitimate policy objective.  G/TBT/M/84  
 
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  4.254.   The representative of Ecuador  provided the following statement. We thank Australia 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 throughout the world for a wide range of strategic 
crops, many of which are produced by Ecuador and imported into the European Union (EU), e.g. 
bananas, cocoa, broccoli, pinea pples, pitahayas, mangoes and cape gooseberries. This compound is 
crucial for pest management because, due to the tropical climate in countries like Ecuador, pest 
behaviour follows patterns that are very different from those prevailing in countries with fo ur seasons 
such as those in the EU, meaning that chemical pesticides for agricultural use with the active 
ingredient mancozeb are vital for agricultural production. Prohibiting the use of mancozeb could have 
a very significant economic impact on small -, medium-, and large -scale producers in Ecuador, as 
well as on consumers in the EU, because the supply of our products would be affected.  Due to the 
way in which this substance is applied in banana production, the use of mancozeb is the most 
effective and envi ronmentally friendly phytosanitary control method for Black Sigatoka. Black 
Sigatoka is considered to be the most destructive foliar disease for banana and plantain crops; it is 
thought to pose the highest economic risk for such crops and can cause yield l osses of up to 50%. 
There are currently no approved and properly registered alternatives to this substance that are as 
effective as mancozeb.  
4.255.   In Ecuador's view, it is vital that studies concerning the renewal of active substances be 
based on scientific evi dence and conclusive data, and not only on the precautionary principle. 
Ecuador refers to Article 2.2 of the WTO TBT Agreement, which states that "Members shall ensure 
that technical regulations are not prepared, adopted or applied with a view to or with t he 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. […] In  assessing such risks, relevant elements of consideration 
are, inter alia : available scientific and technical information, related processing technology or 
intended end -uses of products".  Ecuador therefore urges the EU to take into consideration the 
releva nt scientific information emanating from international specialized agencies recognized by the 
WTO, such as the Codex Alimentarius, which has information relating to this substance.  
4.256.   EFSA decided not to approve the renewal of the use of the active ingredient  mancozeb, 
classifying it in "toxic for reproduction" category 1B, and considers it to be an endocrine disruptor in 
humans and non -target species; however, given the reproductive toxicity hazard profile of 
mancozeb, it would be more appropriate to classify  it in "toxic for reproduction" category 2, or even 
to refrain from classifying it. The toxicity classification of mancozeb must be decided on the basis of 
the active ingredient, and the studies to be taken into account must comply with the analytical and 
procedural rigour required by European regulations. Moreover, mancozeb does not produce adverse 
effects in experimental species of mammals or humans in doses/concentrations lower than those at 
which it might be expected to see effects as a result of system ic toxicity.  Mancozeb has an effect on 
the thyroid hormonal system in a number of mammal species; however, thresholds and reversibility 
have been demonstrated.  On the basis of the foregoing, mancozeb should be classified as "toxic for 
reproduction" categor y 2, and it is not a significant endocrine disruptor in humans. Ecuador requests 
the EU to renew its approval of the use of mancozeb and to maintain its maximum residue levels 
(MRLs) as a risk management measure to ensure and protect the health of consumer s in the EU and 
avoid possible effects on trade. The ban on mancozeb and the subsequent reduction of MRLs for this 
substance in the EU, would leave farmers in countries such as Ecuador without any phytosanitary 
tools for programmes aimed at managing and co ntrolling Black Sigatoka (a pest of economic 
importance) and would prevent resistance, which would have very unfortunate consequences for the 
environment and the economic sustainability of banana crops, as well as social implications, bearing 
in mind that in Ecuador this sector generates between 2  million and 2.5  million jobs for workers at 
various stages of the value chain.  
4.257.   Ecuador also wishes to express its concern about the lack of effective alternative pest -control 
substances, which would exponentially affect to an even greater degree the country's agricultural 
exports, especially given the impact of the current world health situation (COVID -19). We should 
remind the EU that Ecuador was part of a group of 39 WTO Members that, in 2020, called upon the 
EU to temporarily suspend processes related to the review of authorizations for the marketing and 
use of plant protection substances, and their entry into force, in the context of COVID -19, a disease 
that continues to claim  thousands of lives throughout the w orld. For these reasons, Ecuador calls 
upon the EU to consider alternative measures that are less trade -restrictive, to identify substitute 
substances that enable existing trade to continue, to base its measures on conclusive studies, not 
only the precauti onary principle, and to establish transition periods of at least 36 months for the G/TBT/M/84  
 
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  registration of alternative substances, in view of the current shortage of tools available to control 
pests.  
4.258.   The representative of Panama  provided the following statement. The delegation of Panama 
reiterates its concern regarding the non -renewal of mancozeb. The active substance mancozeb is 
vitally important for the country's main crops. Its specific mode of action means that it is 
irreplac eable in the control of black sigatoka, which is the main pest in tropical crops.  I would like 
to reiterate that there are no other active ingredients available to replace mancozeb, leaving the 
industry without any phytosanitary tools and thereby having a severe impact on Panama's exports 
to the European Union.  Panama recognizes the right of Members to determine the appropriate level 
of sanitary or phytosanitary protection necessary to protect human, animal or plant life or health, 
yet such measures must be  science -based and should not create unnecessary barriers to trade.  In 
the light of the foregoing, Panama once again requests that the EU postpone the non -renewal 
process for the MRL for mancozeb.  
4.259.   The representative of Guatemala  provided the following stat ement. Guatemala maintains its 
position on this concern because there is no information on scientific evidence of the damage to 
human health that might be caused by consuming fruits and vegetables, particularly those produced 
in Latin America. The European  Union has mentioned on previous occasions that it has identified 
potentially negative effects on health, without bringing scientific evidence to the discussion table. It 
has failed to provide countries with information on the contamination of products tha t have been 
assessed with the scientific information available. Moreover, the 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 maximum residue levels, 
which will h ave a direct impact on agricultural exports from countries with tropical climates to the 
European Union.  Mancozeb is key for the production of a number of strategic agricultural crops that 
are exported to the European Union, such as fruit (including banana s and plantains) and vegetables, 
which would affect other Latin American countries.  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 
effectiveness. Black Sigatoka is caused by the fungus Mycosphaerella fijiens is, which invades and 
necrotizes the leaf tissue, causing leaf death in perennial banana and plantain crops.  
4.260.   Black Sigatoka is the disease that has the greatest economic impact on banana and plantain 
crops worldwide and can only be successfully controlled with mancozeb.  The ban on the use of 
mancozeb will have a negative social and economic impact on Guatemala, given that both plantain 
and banana crops are a significant source of job creation, foreign exchange and food for the country. 
The crops provide ove r 280,000 direct and indirect jobs, thereby affecting more than 1,120,000 
Guatemalans. Banana exports for Guatemala account for 30% of total exports of traditional products 
from the customs territory.  The banana is the world 's most consumed and exported fr uit 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 European Union to maintain the current maximum residue levels for 
mancozeb so as to avoid affecting the production and exports of Guatemala and other Latin American 
countries, particularly given the economic and social impact that this type of measure will have on 
develo ping countries. We reiterate the request set out in documents G/SPS/GEN/1778  and 
G/TBT/GEN/296 , especially given the ongoing COVID -19 situation.  
4.261.   The representative of Chile provided the following statement. Chile appreciates the 
opportunity to once again point out to the EU that the notified measure, as indicated  by previous 
delegations, will create an unnecessary obstacle to the trade of our agricultural export sector.  
4.262.   The representative of Uruguay  provided the following statement. Mancozeb is an active 
substance that is authorized and widely used in a safe manne r in Uruguay for the control of diseases 
and pests in various national fruit and vegetable sector products, including apples, pears and citrus 
fruits. It is particularly important for the control of apple and pear scab, which is the main disease 
affecting apple and pear production and is caused by fungus of the genus  Venturia  spp. In this 
connection, we support the concerns and requests raised by other delegations, particularly with 
respect to the possibility that the EU may significantly reduce the corresp onding maximum residue G/TBT/M/84  
 
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  levels, even lowering them to the limit of determination, without having any conclusive scientific 
evidence that substantiates such a decision in line with the WTO SPS Agreement.  Against this 
backdrop, like other Members, Uruguay rec alls the importance of taking due account of international 
standards, guidelines and recommendations and the scientific information produced by international 
standard -setting bodies recognized at the WTO, such as the Codex Alimentarius.  
4.263.   In response, the re presentative 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 approval 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 criter ia as outlined in Article 4 of Regulation (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 ent ry 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  authorizations and the grace 
period have been extended, when compared to the original proposal, in order to accommodate 
requests.  
4.264.   Following non -approval and the expiry of all grace periods for stocks of products containing 
this substance, separate action on Maximum Residue Levels (MRLs) may  be taken and a separate 
notification will then be made in accordance with SPS procedures. The EU would like to inform 
Members that EFSA has recently started a review of the existing MRLs for dithiocarbamates (group 
of which mancozeb is part). Interested parties are invited to actively contribute with relevant 
information to this MRL review through the main authorization holder, as described in document 
G/SPS/GEN/1494/Rev.1 .52 For advice on alternatives to mancozeb, the EU pesticides database53 is 
publicly available and contains information on all active substances, their approval status and their 
main purpose (e.g. fungicide, insecticide or herbicide). As regards the joint request for the 
suspension of the processes and entry into force of reduction of Maximum Residue Levels (MRLs) of 
plant protection products in light of the COVID -19 pandemic in documents G/SPS/GEN/1778  and 
G/TBT/GEN/296  and subsequent revisions, the EU has informed WTO Members of its position in the 
last three WTO/S PS Committees (respectively, on 25 -26 June 2020 - G/SPS/R/99 , 5-6 November 
2020 – G/SPS/R/100  and 25 -26 March 2021 – G/SPS/R/101) . In addition, the EU position is included 
in document G/SPS/GEN/1814/Rev.1  of 6 November 2020.  
4.1.3.23   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1166  
(ID 66654) 
4.265.   The representative of the United States  provided the following statement. The United States 
reiterates its concerns regarding the Kingdom of Saudi Arabia's emergency notification of its 
"Technical Regulation for the Restrictions of Hazardous Substances (Ro HS)," which noted an 
adoption date of 7 January 2021. We thank Saudi Arabia for sharing its updated draft of the RoHS 
regulation with the United States on 23 March through the WTO TBT Enquiry Point. We encourage 
Saudi Arabia to fully take into account comm ents from interested stakeholders before finalizing the 
measure. Does Saudi Arabia have an update on when it intends to finalize the regulation? In its 
notification, Saudi Arabia noted that the measure would enter into force six months from the "date 
of publication ". Does the "date of publication " refer to the 1 December 2020, date of the notification, 
or a future date on which the finalized measure will be published? We request a reasonable interval 
for implementation of no less than six months from the da te the finalized measure is published to 
allow time for industry to adapt to these new certification requirements. The Type Approval 
Conformity Assessment testing and certification regime and factory certifications laid out in the draft 
regulation raise co ncerns regarding the feasibility of the procedures and whether the measure has 
the effect of creating unnecessary obstacles to trade. The United States requests that Saudi Arabia 
 
52 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl -review_en.pdf   
53 https://ec.europa.eu/food/plant/pesticides/eu -pesticides -db_en   
54 For previous statements follow the thread under ID 666 . G/TBT/M/84  
 
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  clarify these requirements and avoid creating any duplicative or unnecessaril y trade restrictive 
conformity assessment requirements.  
4.266.   According to the draft regulation, producers must send documentation proving compliance, 
as well as samples of all models of their products, to a SASO -approved conformity assessment body 
to undergo a conformity assessment procedure as outlined under ISO/IEC 17067. How does SASO 
envision that conformity assessment bodies will be able to carry out the mandated Type Approval 
Conformity Assessment on fully assembled electrical and electronic equipment (EEE ) given that 
doing so would require disassembling the product for testing? Further, what EEE parts does SASO 
consider to be "risky" as mentioned in the regulation? The US stresses that Suppliers Declarations 
of Conformity as described under ISO 63000 are t he usual proof of compliance for RoHS -type 
regulations due to the need for producers to gather proof of compliance from their numerous parts 
and materials suppliers. The US requests that Saudi Arabia accept Suppliers Declarations of 
Conformity as proof of compliance with the RoHS procedures. US industry has also raised concerns 
that the amount of documentation required in the measure is more extensive than necessary and 
may require companies to divulge confidential business information without explaining ho w such 
information will be protected. Can Saudi Arabia provide specific guidance on what information will 
be required in product filings and other administrative measures and how confidential business 
information will be protected?  
4.267.   The draft regulation req uires ISO 9001 or equivalent certification for factories. Can Saudi 
Arabia clarify which factory in the manufacturing supply chain this certification refers to, as there 
are numerous parts in electrical and electronic equipment which are assembled by diffe rent 
manufacturers? We understand from SASO that the exemptions have been expanded to include 
exemptions under EU RoHS Annex III. We ask that the exemptions be further expanded to include 
exemptions under EU RoHS Annex IV for measuring and controlling inst rumentation and equipment. 
We also ask that Saudi Arabia update the exemptions in the future to adopt additional exemptions 
that may be added to the EU RoHS, such as uses of the four phthalates added as exemptions to EU 
RoHS II. Particularly concerning for  the toy industry is a deviation from EU RoHS, which changed 
the conformity assessment requirement from a self -declaration of conformity to having to provide a 
certificate of conformity to SASO. Can Saudi Arabia clarify which standards the compliance 
certificates are based on?  
4.268.   The representative of the European Union  provided the following statement. The European 
Union would like to reiterate its concerns regarding the draft Technical Regulation for Restriction of 
Hazardous Substances, notified by Saudi Ara bia on 1 December 2020 would like to refer to its written 
comments of 30 March 2021. According to information provided by the Saudi Standards, Metrology 
and Quality Organisation (SASO), the technical regulation was adopted on 28 January 2021. Could 
Saudi A rabia confirm the status of the text and share the date of its publication and expected entry 
into force? Saudi Arabia mentioned in the last Committee that SASO is considering to review some 
aspects of conformity assessment and the European Union noted the  public consultation published 
on 7 April 2021. Could Saudi Arabia explain the purpose of this public consultation? Is SASO 
considering further changes to the Technical Regulation for Restriction of Hazardous Substances, 
including a new notification to the  TBT Committee?  
4.269.   The European Union would like to recall the following concerns. The  notified text requires a 
mandatory third -party conformity certificate, issued by a conformity assessment body approved by 
SASO and based on test reports from an accredited  laboratory. This would deviate from common 
international practice, followed also by the European Union, which relies on first -party declaration of 
conformity drawn up by the manufacturers or their authorized representatives and would bring 
significant hur dles to businesses. The EU therefore would like to invite Saudi Arabia to consider 
limiting the conformity assessment requirements to the submission of a first party declaration of 
conformity to be provided by manufacturers. In addition, the EU would like to know whether 
conformity assessment bodies not established in Saudi Arabia could be approved by SASO and under 
which conditions. The EU would also like to invite Saudi Arabia to provide for a sufficiently long 
transition period that would ensure a smooth  implementation and adaptation for economic operators. 
The proposed six -month transitional period, even if accompanied by the possibility for suppliers to 
circulate the products that are not fulfilling the requirements of that regulation, for a maximum of 
one year from the date of publishing of the notified text, would not allow companies sufficient time 
to prepare for the conformity assessment procedure proposed in the notified text, which differs 
significantly from European Union practice. In that respect , a transitional period of at least 18 months 
would be necessary. The notification message for G/TBT/N/SAU/1166  provides under point 4 a list G/TBT/M/84  
 
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  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 draft regulation is exhaustive and whether it covers the 
same products as those covered by Annex 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).  
4.270.   Whilst we notice the definition of "homogeneous substance " in the notified text, the EU would 
also like to seek clarification whether the "allowed percentages " of the restricted substances listed 
in Annex (1.b) of the notified text are to be applied by weig ht in homogeneous materials as 
prescribed in Annex II to EU RoHS. More specifically, we would seek clarification whether the 
"allowed percentages " are to be applied to homogeneous materials/components of electrical and 
electronic equipment as it is the case in the EU, or to the electrical and electronic device (as defined 
in the notified text) as a whole. The EU notices that the exemptions in the no tified text are not the 
same as the exemptions included in the Annex III of the EU RoHS. This is significant as the 
electronics supply chains are global. The EU would also like to seek clarification whether Saudi Arabia 
plans to align to the future exempti ons under the EU RoHS and/or whether Saudi Arabia intends to 
lay down an exemptions granting mechanism in their legislation. Finally, the EU would like to know 
what is the relationship between this notified text and the draft Gulf Cooperation Council for t he 
Arab States (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 timef rame 
for its adoption? When adopted, will Saudi Arabia replace its national rules with those in the GCC 
related text? The EU would like to invite Saudi Arabia to promote the GCC harmonized requirements, 
which should also guarantee their uniform application  and a mutual recognition of conformity 
assessment results in the region. The European Union remains available to discuss this issue with 
Saudi Arabia bilaterally.  
4.271.   The representative of Japan  provided the following statement. Japan expresses appreciation 
for the amendment that reflects part of Japan's concerns such as designation of exemptions in the 
new draft Technical Regulation for Restriction of Hazardous Substances in Electrical and Electronic 
Equipment (EEE). However, Japan continues to have the follo wing concerns. 1. The Kingdom of 
Saudi Arabia explained in the last TBT Committee that it chose to apply the international standard 
ISO/IEC 17067, which is type approval, for granting certificates of conformity. However, Japan 
understands that it is not fe asible for both conformity assessment bodies and manufacturers because 
thousands, to tens of thousands, of homogeneous materials are contained in one EEE and the test 
is required to be conducted for each homogeneous material. It would require a tremendous increase 
in workload and cost to do so. Japan would like to request that the manufacturer's self -declaration 
of conformity based on the international standard IEC63000 be accepted. Or, Japan would like to 
request that a more flexible and feasible method be  accepted during the reviewing period for 
conformity assessment that the Kingdom of Saudi Arabia mentioned in the last TBT Committee 
meeting. 2. Japan would also like to request that the technical regulation exclude EEE and its repair 
parts and consumables  for those EEE already on the Saudi Arabian market before the entry into 
force of the regulation. It would be impossible for manufacturers to manage products that are 
already on the market. Also, since batteries have already been regulated by the Technical  
Regulations on the General Safety of Electrical Batteries which was published on 21 December 2018, 
Japan would like to request that batteries be excluded from the regulation in order to avoid double 
regulation. 3. In addition, in order to properly and ful ly implement the technical regulation, Japan 
would like to request publication of a detailed guidance and at minimum a one -year of grace period 
after publication of the guidance.  
4.272.   The representative of China  provided the following statement. In this regulat ion, suppliers 
need to obtain a conformity certificate (Type 1a) from an approved certification organization. In 
order to respond to the testing report requirements described in the notified regulations, a full 
product testing report is needed, which means  that companies need to test every single component, 
at the homogenous material level, which is extremely time -consuming and resource -consuming. On 
the contrary, the international standard IEC 63000 allows manufacturers to work with their supply 
chains to compile technical documentation as evidence of compliance, which is a common procedure 
or method for restrictions on hazardous substances implemented and accepted by international 
community. Therefore, it is recommended that the conformity assessment proce dures would comply 
with current global practices, and the preparation of technical documents would comply with IEC 
63000. Article 4.4 of the European directive 2011/65/EU on the restriction of the use of certain 
hazardous substances in electrical and elect ronic equipment (EU -RoHS) provides exemptions for the 
cables and spare parts for the repair, the reuse, the updating of functionalities or upgrading of G/TBT/M/84  
 
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  capacity of the equipment which have been placed on the market before the applicable date of the 
Regulat ion. The purpose of these exemptions is to extend the lifetime of the equipment and it is 
therefore beneficial to the environment. It is recommended that Saudi Arabia includes such 
exemption in the upcoming RoHS regulation.  
4.273.   The application scope of the dra ft regulations of this notification is electrical and electronic 
equipment, but the batteries and accumulators (HS code 8506 and 8507) are included in Appendix 
2-b. Based on the differences between batteries and electrical and electronic equipments, and ta king 
reference of the current management and control on batteries and electrical, electronic equipments 
across the world, it is recommended that batteries and accumulators are excluded from the scope 
of this regulation. Regarding the allowable percentage o f hazardous substances in electrical and 
electronic equipments or devices specified in Appendix (2), many materials (copper alloys, steel 
alloys, and high -temperature solders, etc.) are currently unable to meet the limitation requirements 
in the regulation s due to immature technology or no alternative materials. It is recommended to 
refer to Annex III of the EU Directive 2011/65/EU (RoHS) or the "Exemption List for Application of 
Restricted Substances in the Compliance Management Catalogue" issued by the Mi nistry of Industry 
and Information Technology of China to clarify the corresponding exemptions. It is recommended to 
clarify the qualification of laboratories, and publish the list of eligible laboratories. In view of the 
impact of COVID -19, we suggest the  transitional period for the implementation of the regulations to 
be extended from six months to 18 months.  
4.274.   The representative of the United Kingdom  provided the following statement. The United 
Kingdom would like to thank the Kingdom of Saudi Arabia for th eir engagement to date on 
notification G/TBT/N/SAU/1166 , which sets out technical requirements for the restriction of 
hazardous substances in electrical and electronic equipment. The United Kingdom fully supports the 
Kingdom of Saudi Arabia's endeavours to protect human health. H owever, we still encourage the 
use of self -declaration for product conformity, combined with requiring manufacturers to appoint a 
local "authorised representative " accountable to authorities for product compliance. This would 
reduce costs and technical and  administrative burdens for industry, facilitate trade in support of the 
Kingdom of Saudi Arabia's Vision 2030 strategy, provide good product compliance governance, and 
align with international best practice on the proportionate risk management for these p roducts. The 
United Kingdom remains concerned that the transition time between adoption and entry into force 
is too short for industry to adjust to the conformity assessment procedures. We understood that the 
Kingdom of Saudi Arabia was considering an exte nsion to the transition period. We would welcome 
further information on these deliberations. We believe that a transition period of at least 18 months 
from the publication of this technical regulation would allow for a smooth and effective 
implementation o f the new requirements. The United Kingdom seeks further information on the 
health problems detected by the National Surveillance Authorities which justified notification of this 
measure as urgent, under Article 2.10 of the TBT Agreement. The United Kingdo m greatly 
appreciates our recent constructive engagement on this matter, and the Kingdom of Saudi Arabia's 
openness to collaborate. We look forward to continued discussions in this respect.  
4.275.   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 restricting hazardous materials in electrical and electronic equipment. 
While we share the Kingdom of Sau di Arabia's legitimate objective to protect the environment and 
public health and safety, Switzerland remains concerned that these requirements may have a 
negative impact on trade for a wide range of products. The testing and certification requirements 
seem to deviate from the internationally accepted RoHS requirements, which are also used in 
Switzerland and elsewhere in Europe. These widely accepted best practices include supplier's 
declaration of conformity and technical documentations aligned to the appr opriate relevant 
international standard (ISO 63000). We encourage the Kingdom of Saudi Arabia to consider less 
trade -restrictive alternatives and take these best practices into account. Finally, we call on the 
Kingdom of Saudi Arabia to allow for a suffici ent implementation period so as to allow the industry 
to adapt to these new requirements. Switzerland looks forward to further engaging with the Kingdom 
of Saudi Arabia on this topic.  
4.276.   The representative of Canada  provided the following statement. Canada wo uld like to 
support the points made by other delegations today and refer to its statement from the February 
2021 TBT Committee as noted in paragraphs 2.25 and 2.26 of the minutes of that meeting.  G/TBT/M/84  
 
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  4.277.   In response, the representative of the Kingdom of Saudi Arab ia provided the following 
statement. Saudi Arabia would like to express appreciation for the concerns addressed by the 
European Union, the United States, Japan, China, the United Kingdom, Switzerland, and Canada and 
for their valuable comments on this matt er. Saudi Arabia aims to protect human health and safety 
and the environment by regulating to ensure that hazardous substances are not above certain levels 
in consumer products such as electrical and electronic equipment. Consequently, we would like to 
clarify the following: Saudi Arabia has notified the measure in December 2020 and received 
comments until May 2021. Currently, in the process of publishing the regulation in the Official 
Gazette. The transitional period set at 180 days after publishing the re gulation in the Official Gazette 
for Manufacturers to take corrective actions. Saudi Arabia has aligned the last version of the Saudi 
Technical Regulation with global practices such as EU RoHS Directive. As for the conformity 
assessment procedures, SASO ha s chosen to apply the international standard ISO/IEC 17067 for 
granting certificates of conformity (Type Approval) to products issued by Notified Conformity 
Assessment Bodies. Moreover, the test report is considered valid unless there is any change in the 
type of materials used during the manufacturing process. In case it is not possible to perform the 
test on the entire product, the critical components of the device must be tested, which are 
determined by the manufacturer based on the risk assessment and d ocuments assessing the risk of 
those components on the final product in accordance with the standard IEC 63000.  
4.278.   SASO develops conformity assessment activities (certification, audit and inspection, and 
testing activities) in Saudi Arabia to be one of the tr ibutaries that raise the level of quality in the 
national industry and the safety of imported goods presented in the Saudi market, by accepting the 
conformity assessment bodies in the various conformity assessment activities. This process aims to 
ensure th e efficiency of the outputs of the accepted conformity assessment bodies operating in the 
conformity verification activities within the systems and requirements of the technical regulations 
approved to provide the necessary activities according to the scop es of acceptance of these bodies. 
Therefore, SASO chose to engage a notified third -party responsible for granting conformity 
certificates in accordance with the international standard ISO/IEC 17067 as part of the Kingdom pre -
market approach. The technical regulation requirements for Restriction of Hazardous Substances in 
electrical and electronic equipment are in line with international practices. Therefore, the transitional 
period set at 180 days after publishing the regulation in the Official Gazette is s ufficient to fulfill all 
requirements.  
4.1.3.24   India – Draft Food Safety and Standards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 66755) 
4.279.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Cus toms Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to thank India for providing Members with the opportunity to comment on this 
proposed regulation. While we fully support India's objective to ensure the safety of imported food 
products, we also  urge India to observe the principle of transparency in relevant implementing 
measures of this regulation. Our comments on this proposed regulation were sent to India on 30 
December 2020, which sought clarification of a number of points regarding the categ ories of food to 
be covered. We look forward to the response from India.  
4.280.   The representative of the European Union  provided the following statement. The European 
Union would like to highlight its strong concerns with this Indian measure. Many questions for foreign 
food manufacturers and competent authorities remain unanswered, which would create an 
unpredictable trading environment. Most importantly, the proposed standards appear much more 
trade restrictive than necessary to fulfill the intended food safety objectives. We sent you written 
comments and are still waiting for a written reply. I want to highlight our main elements of concern. 
The transition period is too short and should be extended to 18 months. India should further clarify 
the scope of products /food categories. A list of low -risk products should be d efined that should be 
exempted. An example would be wines and spirits due to their inherent stable nature. Inspections 
and audit of foreign food manufacturing facilities as well as registration need to be clarified and 
simplified.  
4.281.   The representative of Mexico  provided the following statement. Following up on the concern 
raised about this measure in the TBT Committee in February 2021, the Government of Mexico 
reiterates the importance of the delegation  of India providing more clarity on the products subject 
 
55 For previous statements follow the thread under ID 667 . G/TBT/M/84  
 
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  to this Regulation and confirming whether alcoholic beverages are part of this list. It will also be 
important to know the risk -based procedure that will be followed to determine the products covered . 
In light of the above, we would be grateful if the delegation of India could share information on the 
Regulation, the manner in which it will determine product categories or types of products that will 
be subject to compliance, as well as information on how the on -site inspections or visits will be 
conducted, and on the entry into force and the current status of this Regulation.   
4.282.   The representative of the United States  provided the following statement. The United States 
remains concerned with India's draf t 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. The United 
States raised this issue at the TBT Committee meeting in February 2021, and India responded that 
it was reviewing comments received. The United States wishes to reiterate our main concerns, and 
we ask that India please provide a more detailed response and update on the statu s of the proposed 
regulation. 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 lack of detail regarding 
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 c ommunicated 
to the public. Will India publish an updated list of food products included in such "risk" categories? 
Will stakeholders have an opportunity to submit comments on these categories or appeal risk 
determinations? Could India please clarify what i s meant by "from time to time "? Does India intend 
to undertake regularly scheduled systematic reviews of food categories? Finally, we ask that India 
please provide clarity regarding its inspection and audit procedures, including who is financially 
responsi ble for a food facility's audit expenses, and a proposed timeline when audits are first required 
to take place.  
4.283.   The representative of Japan  provided the following statement. Japan shares the concerns on 
India's proposed draft amendment regulation on food s afety and standards. While the regulation 
would impose additional burdens on business operators who export to India, there are many unclear 
points yet to be sufficiently explained by India including definitions of "food manufacturing facility ", 
scope of "food" subject to the draft regulation, and registration procedure of the facility inspection 
and audit. Japan would like India to make TBT and SPS notification and provide WTO Members with 
the opportunity to make comments on the detailed regulation regardin g the scope of food, the 
registration procedure of facilities and so on. Furthermore, Japan underlines the importance to have 
sufficient transition period before the implementation of the new rules. Japan consider that 180 days 
transition period from publi cation in the Official Gazette is not enough. Japan recommends that this 
period be extended more than 18 months. Japan would like to urge India to address the concerns 
and comments from Member countries appropriately  so that the proposed new rule would not  create 
unnecessary trade barriers.  
4.284.   The representative of Australia  provided the following statement. Australia recognizes 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 the 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 than necessary to fulfill India's food safety objectives. Australia believes the 
regulations will create an additional burden on both pro ducers and exporters in Australia, and cause 
disruption for Indian importers and customers. Clarity on the categories of food manufacturers and 
the basis for determining when the regulations apply are lacking. Australia is concerned that the 
proposed measu res may not be linked to the risks posed by the imported food. Australia respectfully 
requests that India recognize the domestic and export regulatory systems of foreign countries, where 
the system meets equivalent outcomes, in order to reduce duplication in regulatory requirements 
for producers and ensure government resources are used efficiently to protect consumer health. 
Australia welcomes India's consideration of our comments and 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. Australia is grateful for productive discussions held with India earlier 
this year and recognizes India's commitment to reviewing comments provided in written 
submi ssions.  G/TBT/M/84  
 
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  4.285.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at the February 2021 TBT Committee Meeting regarding India's draft 
amendment to its Food Safety Standards (Import) Amendment Regulation pe rtaining to the 
registration, inspection and/or audit of foreign food manufacturing facilities producing food products 
destined for India. While Canada recognizes India's right to take necessary measures to protect 
public health and safety, a number of ele ments contained in India's proposed order remain 
ambiguous. Canada would appreciate further details on the target commodities, source -countries, 
implementation plan, audit rates, compliance actions, and appeals. Specifically, it is unclear what 
criteria wo uld be used to determine the level of risk for food products imported into India, what 
circumstances would instigate an audit or an inspection of a foreign manufacturing facility or how 
such actions will be taken given the ongoing travel restrictions resul ting from the pandemic. Further 
information is also 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. 
Canada would appreciate if I ndia could confirm its understanding that the measure would apply only 
to processed products and not to bulk/fresh/caught products such as pulses, horticulture products 
such as fresh cherries, and fish and seafood products.  
4.286.   Canada also requests further cla rification on whether low -risk foods will be required to meet 
FSSAI's registration and inspection requirements. In this regard, Canada suggests a risk -based 
approach which would exempt foods with low food safety risk such as alcoholic beverages. We look 
forward to receiving responses to our comment letter submitted to India's Enquiry Point on 
21 January 2021. In closing, given that India's proposed regulation covers food safety measures 
aimed at protecting human health and safety, Canada respectfully reques ts that it be notified to the 
WTO SPS Committee in order to provide an opportunity for Members to comment.  
4.287.   The representative of Argentina  provided the following statement. Argentina wishes to 
reiterate the concerns raised during the previous meeting of th e Committee.  As we have already 
stated, my country has a number of doubts about giving effect to and implementing the provisions 
contained in the draft standard notified in document G/TBT/N/IND/180 , particularly with regard to 
the products covered and the provisions on registration , inspection and audit of exporting 
establishments.  All our questions have been duly submitted through India's TBT Focal Point and we 
are yet to receive the corresponding clarifications. We hope to receive them as soon as possible and 
also hope that this n ew standard does not become an unjustified restriction, in order to ensure that 
trade with India, a highly important trading partner for our country's agricultural sector, is not 
affected.  
4.288.   In response, the representative of India provided the following sta tement. We thank the 
Members for their continued interest in the issue. At this time, the comments received from various 
stakeholders are being examined.  
4.1.3.25   Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011 ), G/TBT/N/RUS/2  (ID 33256) 
4.289.   The representative of the European Union  provided the following statement. In 2012, the 
Russian Federation notified a draft technical regulation on safety of alcoholic products to be adopted 
by the Eurasian Economic Union. An updated version was adopted in  December 2018 and initially 
supposed to enter into force on 9 January 2021, however postponed to January 2022. The technical 
regulation also contains provisions covered by the Agreement on trade -related aspects of intellectual 
property rights. The EU woul d like to invite Russia to also notify the regulation to the Council for 
TRIPS, as some of these provisions, in particular impacting EU geographical indications, raise serious 
concerns for the EU. The EU took the opportunity of the ongoing revision process  of the Eurasian 
Economic Union Technical Regulation 047/2018 "On the safety of alcoholic products " and submitted 
on 19 May to the Eurasian Economic Commission a series of drafting proposals. The Russian 
Ministries of Agriculture, Finance and the Economic Development have also been informed. In light 
of transparency and considering the trade implications of this regulation, we understand that the 
revised draft technical regulation will be subject to public consultation and that it will be notified to 
the WT O under the TBT Agreement.  
4.290.   We have based our amendments on both the original text of the technical regulation as well 
as the draft amendment as proposed by the Ministry of Finance of the Russian Federation. We are 
 
56 For previous statements follow the thread under ID 332 . G/TBT/M/84  
 
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  firmly convinced that the EU proposal, the  focus of which is to better align some provisions with 
international standards and practices for alcoholic products, as well as WTO obligations, would ease 
the implementation and enforcement of the technical regulation by all operators, facilitate 
interna tional trade of alcoholic products both ways, and, thus, contribute to the goal pursued by the 
Eurasian Economic Commission through this text. The European Union would like to ask Russia to 
take these comments into consideration and to renotify the new ver sion of the measure, under the 
TBT Agreement as well as under the TRIPS Agreement.  
4.291.   In response, the representative of the Russian Federation  provided the following statement. 
We appreciate the European Union's interest in the Russian Federation and EAEU's regulatory policy. 
The provisions of the EAEU  Technical Regulation on Alcohol Drinks Safety are in full compliance with 
the Russian and other EAEU members' obligations in the WTO. As stated previously on various 
occasions, this Technical Regulation does no t set any requirements for ensuring protection of 
intellectual property rights and is not aimed at implementation of the Agreement on TRIPS. In this 
regard, we do not see any reason to notify this legislation to the Council for TRIPS. As rightly 
mentioned by the European Union, the EAEU Technical Regulation on Alcohol Drinks Safety was 
adopted in December 2018 and is supposed to enter into force in January 2022. Despite the fact 
that the Technical Regulation has not entered into force, draft amendments base d on numerous 
requests from various stakeholders have been prepared by the Russian side and made available on -
line for national Regulatory Impact Assessment. After this procedure is finished at the national level, 
draft amendments will be forwarded to the Eurasian Economic Commission for consideration. Having 
been preliminary considered at the Eurasian Economic Commission, the draft will be posted for public 
consultations, notified to the WTO under the Agreement on TBT and will be available for comments 
of WTO Members.  
4.1.3.26   European Union - Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) No 
479/2008 as regards protected designations of origin and geographical indication s, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/44,  G/TBT/N/EEC/264,  G/TBT/N/EEC/264/Add.1 , G/TBT/N/EU/570,  
G/TBT/N/EU/571  (ID 34557) 
4.292.   The repres entative of the United States  provided the following statement. It is very 
disappointing that the United States must again raise its concerns with the European Union's 
revisions to its draft regulation on geographical indications and traditional terms for wine; and 
specifically, our industry's pending applications for traditional terms. The EU's persistent failure to 
provide any information leaves us no choice but to raise this issue here again at the WTO TBT 
Committee, as well as most recently at the WTO C ouncil for Trade in Goods in March 2021. 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. Wh y is the EU still unable to provide any estimate or tell us where in the process these 
applications are after three years? What does the EU mean when it said "under consideration? " Are 
they being actively considered, or have they been put on hold? If the a pplications have been put on 
hold, please explain why.  
4.293.   As we have indicated at each TBT Committee 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 applicati ons compare. As requested during the February, May, and October 2020, and 
February 2021 TBT Committee meetings, please tell us the following: how many applications for 
traditional terms have been lodged over the last 11 years; how many of those application s have 
been approved, rejected, or remain pending; what is the average time between application and a 
final decision; for pending applications, how long have they been waiting; and how many of the 
applications have come from member States? Can the EU confi rm 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 Novem ber 2019 but has not received clarification from the EU.  
4.294.   We again thank the EU for its 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. Confir mation  that US producers can continue to use any generic term, such as a grape 
 
57 For previous statements follow the thread under ID 345 . G/TBT/M/84  
 
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  variety, 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 th e compound name 
"Montepulciano d'Abruzzo ". How do third countries find out about amended 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 pa rties "… 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 comment 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 se ek confirmation that the revised 
regulation will not alter the ability of US producers to use terms such as "barrel aged " as provided 
for in Appendix II of the Protocol on Labelling to the 2006 US/EU Wine Agreement. In its response 
to our TBT comments, the  EU indicated that "consumers' expectations have been taken into account 
by reserving 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.  
4.295.   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 the October 2020 TBT Committee, 
and those preceding it. 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 Members 
relating to the scope  and application of the system of traditional terms, as well as transparency, 
process, and timelines relating to applications by third countries who wish to use traditional terms 
in the European Union.  
4.296.   The representative of Brazil  provided the following st atement. Brazil would like to support 
the concerns raised by the US and refer to our past statements on this STC. We kindly ask the EU 
to share any updated information related to the use of regulated terms for wines exported to the EU 
in Regulation (EC) No . 607/2009 and Council Regulation (EC) No 479/2008.  
4.297.   In response, the representative of the European Union  provided the following statement. 
The EU understands the continued interest of the United States and other Members in this issue. 
The EU has completed  the revision of its internal legislation on traditional terms discussed in previous 
TBT Committees leading to the adoption of Commission Delegated Regulation (EU) 2019/33 and 
Commission Implementing Regulation (EU) 2019/34. The EU believes that its intern al 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 a rea either via its internal legislation or via bilateral 
agreements.  
4.1.3.27   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/A dd.3,  G/TBT/N/ IND/44/Add.4,  
G/TBT/N/IND/44/Add.5,  G/TBT/N/IND/44/Add.6 , G/TBT/N/IND/44/Add.7 ,  
G/TBT/N/IND/44/Add.10 , G/TBT/N/IND/47,  G/TBT/N/IND/47/Add.1,  
G/TBT/N/IND/47/Add.1/Corr.1,  G/TBT/N/IND/47/Add.2,  G/TBT/N/IND/47/Add.3,  
G/TBT/N/IND/58  (ID 36758) 
4.298.   The representative of the United States  provided the following statement. We thank India 
for taking into account US industry's request that India extend the enforcement pe riod of Phase V 
of the Compulsory Registration Order (CRO) for electronics and information technology goods by six 
months to provide industry with the necessary time to adapt products and methods of production to 
comply with India's CRO requirements. We un derstand that US industry has expressed concerns 
that, although India provides six months for industry to comply upon the announcement of each 
new CRO phase, these announcements do not include the necessary resources and guidance for 
compliance. Specifical ly, announcements of each CRO phase thus far have lacked the following 
necessary resources and guidance, which India has not provided until weeks after the 
announcement: (i) product  series guidelines and FAQs from MeitY; (ii) the new Test Report Format 
from the Bureau of Indian Standards (BIS); (iii) a BIS portal for submitting applications; and 
 
58 For previous statements follow the thread under ID 367 . G/TBT/M/84  
 
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  (iv) 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 impossible to fully comply 
with the CRO's registration requirements within the allotted timeframe. With respect to future 
Phases, we ask that MeitY provide a transition period of one year, but no less than six months, from 
the date on which all fou r of the necessary resources and guidance listed above have been made 
available.  
4.299.   The representative of Canada  provided the following statement. Canada welcome the delay 
in the entry into force of the measure, from 1 April to 1 October 2021, as confirmed by  India's WTO 
notification G/TBT/N/IND/44/Add.10  of 22 April 2021. While Canada recognizes the challenges the 
COVID -19 pandemic poses to India, we note the difficulty firms face in quickly adapting to changes 
in requirements and seek India's agreement to provide ample ti me for exporters to modify their 
procedures. Canada continues to urge India to adopt IEC standards and to recognize test results 
from internationally accredited labs. As noted in previous meetings, Canada remains concerned by 
the Compulsory Registration Or der, for the following reasons: it requires  product testing be done 
only by Bureau of Indian Standards -accredited labs located within India; it does not allow for the 
use of international standards; and it does not recognize test results from international ly accredited 
labs. 
4.300.   In response, the representative of India provided the following statement. The Ministry of 
Electronics and Information Technology (MeitY) has notified seven product categories under the 
phase V Electronics and Information Technology Goo ds (Requirements for Compulsory Registration) 
Order (CRO) on 1 October 2020, which is scheduled to be effective from 1 October 2021. The BIS is 
granting the registrations in consultation with MeitY. Product series guidelines from MeitY are already 
issued a nd available on the MeitY website.59 The test report formats have been issued and are 
available on the BIS website.60 Provision for submission of application for Phase – V on BIS portal is 
already made. The number of laboratories recognized by the BIS for all the products under phase 5 
of CRS is as under: Wireless microphone: 28 Labs; Digital Camera: 30 labs; Video Camer a: 29 Labs; 
Webcam (Finished Product): 27 Labs; Smart Speakers (with and without Display): 29 Labs; Dimmers 
for LED products: 01 Lab; Bluetooth speakers: 26 Labs.  
4.301.   Relevant weblinks : The details are available on the BIS website www.bis.gov.in  under the 
following tab: Laboratory Services << Test Facilities and Testing Charges<< IS - Wise Test Facilities 
In BIS LAB /Recognised L abs.61 The test reports formats for phase 5 products have been issued and 
are available on the BIS website under the following tab: Laboratory Services<<Uniform Test Report 
Formats to be used by Recognised Laboratories for issuing test reports under Compul sory 
Registration Scheme.62 
4.1.3.28   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1313  (ID 42863) 
4.302.   The representative of the Republic of Korea  provided the following statement. Korea 
welcomes China's recent publication of the Regulations for the Supervision and Administration of 
Medical Devices, which entered into force on 1 June after a lengthy revision process. With the revised 
regulation, medical devices in China will be able to go through a more stringent  safety management 
process across the entire product life cycle, from certification and inspection to market distribution 
and post -market surveillance. We expect this will contribute to maintaining order in the Chinese 
medical device market and thereby pro mote market growth. However, there are some parts in the 
regulation that still require clarification from China. As to our previous enquiry asking about the 
scope of "qualified testing laboratories ", China responded that we should be able to find the answe r 
from the revised regulation. However, it seems that the finalized regulation still does not specify 
what agencies are to be considered "qualified testing laboratories ", which calls for further 
explanation. Korea also wishes to receive a clear answer on w hether the certificates by 
internationally accredited laboratories can be accepted. Provided they are not, a suggested 
alternative would be for China to accept the certificates by internationally accredited laboratories or 
other equivalent foreign laborato ries in order to save time and cost in the approval or registration 
 
59 https://www.meity.gov.in/esdm/standards   
60 https://bis.gov.in/index.php/laboratorys/utrf/   
61 https://bis.gov.in/index.php/laboratorys/testing -facility -and-testing -charges/  
62 https://bis.gov.in/index.php/laboratorys/utrf/  
63 For previous statements follow the thread under ID 428 . G/TBT/M/84  
 
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  process. This will help facilitate trade and appropriately contribute to the growth of China's medical 
device industry.  
4.303.   In response, the representative of China  provided the following stat ement. A new revision 
of the regulation on the supervision and administration of medical devices has been released and 
will take effect on 1 June 2021. The new regulation reasonably sets clinical evaluation requirements, 
simplifies the review procedures, a nd further encourages innovation. Meanwhile, the regulation fully 
implements the registration system, strengthens the responsibility of enterprises and supervision 
over the whole process of medical devices. China is working on the following regulations and  
documents, which will be notified according to the rules. The comments to the regulation will be 
studied, and the regulation will be released afterward.  
4.1.3.29   China - Registration Fees for Drugs and Medical Device Products (ID 46664) 
4.304.   The representative of the Republic of Korea  provided the following statement. Over the last 
several years, Korea has repeatedly raised concerns about China's Registration Fees for Drugs and 
Medical Device Products, and this continues to remain an issue of interest for Korea. Please refer to 
the record of minutes for Korea's comments made in the previous TBT meetings, and this time, 
Korea wishes to reiterate our question: when will the notification on the Charging Standards for Drug 
and Medical Device Regist ration from 2015 be revised? With the possible revision in mind, we would 
like to request China to ensure equal treatment between exporters and Chinese domestic 
manufacturers in imposing registration fees.  
4.305.   In response, the representative of China  provided the following statement. The registration 
fees for drugs and medical devices are common international practice. For example, in 2013 the new 
medicine registration fees of M embers  were mostly around 1 million Yuan, some Members even 
above 10 million Yuan, w hile 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 o f the 
registration fees is due to different workload and price level.  
4.1.3.30   Russian Federation - Rules of cement certification, G/TBT/N/RUS/48,  
G/TBT/N/RUS/49  (ID 49765) 
4.306.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its previous statements in the TBT Commit tee 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, despite our numerous 
reminders. The EU deeply regrets that Russia continues to adopt restricting measures in the area of 
cement certification that are disproportionate, unjustified  and not notified to the WTO before their 
entry into force. Further to this, the EU regrets that Russia is not willing to provide any information 
on the state of play of the preparation of the new standard for cement. 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 
WTO at a draft stage, in line with the rules set out by the TBT Agreem ent. Since the introduction of 
the mandatory certification for cement, EU exports of cement to the Russian Federation are 
practically blocked, with the exception of white cement, necessary for Russian industry. This 
situation remains unchanged since the en try into force of these measures. Given the lack of the 
notification to this day, the EU would like to ask the Russian Federation to inform about the 
preparation of this new standard and to share the updated timing for its TBT notification.  
4.307.   In response, th e representative of the Russian Federation  provided the following statement.  
As the issue has been on the agenda of this and other WTO working bodies for a while, we refer to 
our previous statements made. The amendments to GOST – R "Rules of cement certif ication " are 
being discussed internally among relevant Russian authorities. Unfortunately, no precise timeline for 
the outcome of the discussion can be provided now. Once this work is finalized, we will be glad to 
inform WTO Members on that.  
 
64 For previous statements follow the thread under ID 466 . 
65 For previous statements follow the thread under ID 497 . G/TBT/M/84  
 
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  4.1.3.31   India - Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulations, 2015, G/TBT/N/IND/51,  G/TBT/N/IND/104  (ID 49466) 
4.308.   The representative 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 comments 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 follo wing. 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 minimize the impact for economic operators) and transition period. The presence of some 
technical specifica tions (the maximum alcohol content, some spirits definitions) that may not 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 accept able solution to 
the outstanding issues.  
4.309.   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 co mmitments. In addition to this, alignment of the analysis methods of 
alcoholic beverages with the OIV is under process. FSSAI via direction dated 22 June 2020 
operationalized use of food colours "Tartrazine, Carmoisine, Brilliant Blue, Sunset Yellow and 
Ponceau 4R " in the food category 14.2.6 -Distilled Spirituous Beverages. Further, via direction dated 
7 December 2020, revised provisions for using these colours, and one additional colour, Allura Red, 
was operationalised for use in food category 14.2.6 -Distilled Spirituous Beverages. Further, as per 
appendix A, the colour, namely caramel, beta carotene and grape skin extract, are allowed in 
aromatised alcoholic beverages.  
4.1.3.32   Egypt - Manufacturer Registration System (Decree No. 43/2016 and Decree No. 
992/2015), G/TBT/N/EGY/114,  G/TBT/N/EGY/115  (ID 50567) 
4.310.   The rep resentative of the Russian Federation  provided the following statement.  The Russian 
Federation reiterates its statements in respect of Manufacturer Registration System made during the 
previous meetings of the Committee on Technical Barriers to Trade, Comm ittee on Market Access 
and Council for Trade in Goods. We urge Egypt to register the Russian steel manufacturer that has 
been denied market access since 2016 and revise the Registration System to bring it in full 
compliance with WTO rules. The System  untra nsparent and lacks clear deadlines for the processing 
of applications which provide opportunities for arbitrary decisions regarding market access for 
particular companies and for protection of domestic industries from imports.  
4.311.   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 
succe ssfully processed. The EU calls on Egypt to immediately register all EU companies that have 
updated or will update their quality certificates, without discrimination in relation to the sectors of 
their activity and without the need of restarting the applic ation process. The EU reiterates 
furthermore structural problems related to the implementation of 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 procedu re, and a high level of discretion in granting registrations. Given the lack of 
transparency, the EU has some questions to Egypt: Could Egypt clarify the relationship between 
Decree 43/2016 and Decree 992/2015? This question has been asked before and no cl ear answer 
has been provided to the EU. Could Egypt please explain how the Decree 43/2016 is implemented 
and administered in practice? In particular: Where can companies find the application form and 
where can this application form and related documents be  submitted? What are the related costs 
associated with the submission of applications? What are the deadlines with regard to the registration 
from the moment of the application?  
 
66 For previous statements follow the thread under ID 494 . 
67 For previous statements follow the thread under ID 505 . G/TBT/M/84  
 
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  4.312.   How can companies follow their application and see if it has been approved or rejected or 
whether there are documents that need to be corrected or resubmitted because they have expired? 
In short, how can companies obtain information about their application status at any stage of the 
process? Could Egypt please explain if Egyptian pr oducers/exporters are subjected to similar 
requirements and process as EU exporters are under Decree 43/2016? If so, could Egypt specify the 
legislation subjecting Egyptian producers/exporters to similar requirements? The EU's understanding 
is that registr ation, the suspension or cancellation of registration from the General Organization for 
Export and Import Control's (GOEIC) record is done through a decision of the Minister of Foreign 
Trade. Can you please point us out to where these decisions are publish ed and provide us with copies 
of these decisions? According to GOEIC's website, the Minister of Foreign Trade has absolute 
discretion "and he may exempt from any or all of the registration conditions in the cases he decides ". 
In which instances has the Min ister of Foreign Trade exercised this discretion and on the basis of 
which criteria? The European Union would appreciate a written reply to these questions. As such, 
the measure raises questions of compatibility with the WTO TBT Agreement. The EU would the refore 
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.  
4.313.   The repres entative of Turkey  provided the following statement. We join the European Union 
and Russian Federation to emphasize our ongoing concerns on Egypt's Decree on manufacturer 
registration system. Despite all the concerns and questions from Members in previous meetings, the 
structural problems related to this Decree and implementation still continue. In this sense, the 
system lacks transparency and hence leads to unpredictability, arbitrariness, and additional costs. 
Turkish exporters continue to report long del ays in the registration process and face difficulties in 
obtaining information about their pending registration requests. In this respect, we would like to 
reiterate that we still could not get a clear information on the evaluation criteria for the applica tions 
to GOEIC, steps to be taken for a smooth registration, and time limitation for the completion of the 
registration if there is any. 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.  
4.314.   In response, the representative of Egypt  provided the following statement. We would like to 
refer to your previous statements in the CTG, TBT and Market Access Commi ttee meetings in which 
a number of the questions raised today have already been addressed including the similar 
requirements and surveillance mechanisms domestic producers are subject to. We take note of all 
the questions and concerns that continue to be r aised and they will be conveyed to capital and 
responses delivered in due course. We also conclude by renewing our call to Members whose 
companies are facing specific difficulties to reach out to us with details of the problems faced so that 
we can communi cate them to the Egyptian concerned authorities and come back with concrete 
feedback.  
4.1.3.33   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 22468) 
4.315.   The representative of Japan  provided the following statement. Japan would like to thank 
India for its explanation at the previous meeting. We took note that the purpose of BIS certification 
is to protect the health of humans, animals and plan ts, as well as for environmental safety, and all 
technical regulations issued  by the Ministry of Steel are notified to the WTO. At the same time, Japan 
would like to continue to request that these mandatory standards of steel products in India be 
implement ed in a manner that conforms with the TBT Agreement and that the implementation be 
no more trade restrictive than necessary to achieve its legitimate objectives. To be more specific, 
Japan would like to submit the following comments as pointed out at the p revious meeting. Even 
though Japan requested India to accelerate its examination procedure at the last TBT Committee 
meeting, it is still taking a very long time to get approval of conformity assessment, and it has 
become usual that no response is given to  Japanese steel companies even after a year has passed, 
especially for new projects. This has not improved since the last Committee meeting.  
4.316.   Japan understands that India cannot proceed in application and scheduling on -site factory 
audits by BIS as part of the process of obtaining certification of conformity because of COVID -19 
and its prevention measures. Japan requested India to implement any alternative measures at the 
 
68 For previous statements follow the thread under ID 224 . G/TBT/M/84  
 
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  last TBT Committee meeting, but India has not offered any such measures yet. Therefore,  Japan 
would like to request again that the Ministry of Steel and BIS implement appropriate alternative 
measures and postpone the enforcement of new mandatory standards. In addition, for some 
products, India requested Japanese companies to submit future pl ans for domestic production in 
India or to switch to local procurement from Indian companies which is not related to the conformity 
assessment procedures. Japan also did not receive enough explanations on this point from India at 
the last TBT Committee mee ting. Such additional request is not relevant to the conformity 
assessment procedures, and Japan would therefore like to strongly request again for immediate 
improvement on this issue.  
4.317.   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 Indian Steel and Steel Products Quality Control 
Order, circulated in G/TBT/N/IND/90  on 25 March 2019. While we fully sup port India's objective to 
ensure the safety of imported steel and steel products, we would like to bring to the attention of 
Indian government the significant difficulties encountered by our companies to obtain the 
certification required by the Order. Ther e are applications submitted in January 2019 with testing 
and factory inspection procedures completed in March 2020 and certification is pending without any 
reasons. We understand the difficulties India faces in administering procedures at its normal pace 
during the pandemic. However, we still hope that the Bureau of Indian Standards (BIS) implements 
appropriate alternative measures despite the pandemic to prevent further delays of approval. In 
addition, considering that the pandemic will continue for some time, we would like to urge India to 
postpone the implementation of IS standards, in particular IS 17404:2020 on electrogalvanized hot 
rolled and cold reduced carbon steel sheets and strips, which recently came into force or are about 
to become effective t o allow foreign manufacturers enough time to complete the conformity 
assessment procedure. We thank India for taking into account our comments.  
4.318.   In response, the representative of India provided the following statement. Japan : 
Considering the ongoing pandem ic and the extent of its impact, the information sought by the said 
QCO will ensure smooth supply lines of quality grade material at reduced costs and in a time -bound 
manner. This information is particularly vital, among others, if the importers are import ing from the 
non-BIS licensed manufacturers. As regards the auditing remotely, India is seized of the matter. 
There is no provision in BIS (Conformity Assessment) Regulations, 2018, to undertake virtual 
inspection or the use of recognized third -party certi fication of companies in the country of 
manufacturing to meet the QCO's in -person audit requirements for foreign manufacturing facilities. 
However, the Government of India is considering the introduction of relevant enabling provisions to 
undertake virtual /remote inspection for BIS conformity assessment activities.  
4.319.   Chinese Taipei : G/TBT/N/IND/90  on 25 March 2019 is related to the Essential Requirement 
clause included in the QCO regarding "Stampings/laminations/ cores of Transformers (with or 
without winding) " & "Stainless Steel Pipes and Tubes. " In this regard, it may be noted enforcement 
date for "Stampings/laminations/cores of Transformers (with or without winding) " has been 
extended till 30 June 2021 and "Stainless Steel Pipes and Tubes " is under enforcement since 16 June 
2020.  Regarding postponement of the implementation of IS 17404:2020 (Electrogalvanized hot 
rolled and cold reduced carbon steel sheets and strips), it may be noted that the current date of 
enforcement is 22 June 2021.  The request for the extension of the date of enf orcement of the QCO 
will be examined before the enforcement date. Based on the merits of requests from the stakeholders 
and licence status from BIS against the standard, an appropriate decision will be taken.  
4.1.3.34   China - Cybersecurity Law (ID 52669) 
4.320.   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 commercial sectors. 
China's Cybersecurity Law entered into force on 1 June 2017, in spite of serious and long -standing 
concerns from the United States and many other international stakeholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
 
69 For previous statements  follow the thread under ID 526 . G/TBT/M/84  
 
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  sometime general in scope, and sometimes sector -specific. We have many concerns regarding 
China's Cybersecurity Law and related measures, which impose far -reaching, hig hly trade -restrictive 
conditions on foreign ICT products through "secure and controllable " requirements, enforced by 
cybersecurity review regime checks. Such requirements are largely based on a planned update and 
expansion of the Ministry of Public Securit y'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.  
4.321.   Numerous  other concerns have been laid out in prior interventions by the United States and 
other Members at prior Committee meetings. Additionally, the United States reiterates its serious 
concerns regarding China's Cryptography Law, which went into effect on 1 Ja nuary 2020. The United 
States is concerned 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 b oth novel and would have a potentially widespread 
impact in the commercial sector, the United States requests that China undertake in -depth 
consultations with the US Government, other WTO Members, and global stakeholders. We also 
request that China afford subsequent opportunities for interested parties to submit comments on 
revised iterations of draft standards and all other implementing measures related to the 
Cybersecurity Law. Given the broad potential impact of these standards and measures and the 
serious concerns they have raised, it is critical 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 
measures, as well as the Cryptography Law. We look forward to continuing this important dialogue 
with you.  
4.322.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its state ments 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 regarding 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 informa tion 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 security. 
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 
localization and security assessment requirements, foreign 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, necessity and technolog y 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 expected implementation  timeline. 
The EU requests that China notify 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.  
4.323.   The representative 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 February 2021. Japan is concerned with related enforcement 
regulation as well. Japan would like to request that China provide notification of the enforcement 
regulation s to the TBT Committee and consider comments from stakeholders. In addition, Japan 
would like to request that China provide adequate lead time from completion of these regulations 
until their enforcement, and to implement these measures in a transparent ma nner.  
4.324.   The representative of Australia  provided the following statement. Australia appreciates 
China's efforts to consult with interested parties on its measures relating to cybersecurity, including 
China's May 2021 public consultation process on its revise d draft Data Security Law and revised 
draft Personal Information Protection Law. The Australian Government submitted comments on the 
first draft of these proposed laws last year. We welcome a number of the revisions to these laws but 
continue to encourage China to provide as much detail as possible, especially when it comes to 
issues such as the scope of the laws. Australia reiterates that, consistent with the TBT Agreement, 
we expect that measures will be implemented in a non -discriminatory manner and in a  way that is G/TBT/M/84  
 
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  no more trade restrictive than necessary. Australia further urges China to consider less trade -
restrictive measures that are reasonably available to achieve its objectives.  
4.325.   In response, the representative of China  provided the following statem ent. 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 responsibilities and 
obligations of government authorities, network providers, user s, etc. Since the implementation of 
the cybersecurity law, it has played an important role in safeguarding the national cyber security. 
The purpose of enacting and implementing the cybersecurity law is to safeguard the national 
cyberspace sovereignty, nati onal security, social and public interests, and to protect the rights and 
interests of citizens, legal persons and other organizations.  
4.1.3.35   China - Encryption Law of the People's Republic of China by the Office of State 
Commercial Cryptography Administration ( OSCCA) (ID 53470) 
4.326.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate its concern relating to the Cryptography Law that came into force on 1 January 2020. 
The EU remains concerned about the wide scope o f the law, in conjunction with the lack of clarity of 
a number of foundational concepts as well as the administrative procedures described in the text. 
These factors will negatively impact business confidence. The EU also notes with concern that the 
new la w does not recognize China's previous commitment made in 2000 that the cryptography -
related regulation would only apply to products whose core function is that of providing encryption 
– the so -called "Year 2000 Clarification" by the State Cryptography Admi nistration (SCA). The EU 
calls on China to ensure that legal and regulatory requirements are based on a non -discriminatory 
basis, do not favour specific technologies, do not limit market access and do not lead to a forced 
transfer of intellectual property.  The EU urges China to guarantee the possibility for foreign invested 
enterprises (FIEs) to participate on an equal footing with domestic companies in the production, 
research, development and sale of cryptography products on its market.  
4.327.   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 February 20 21. 
Japan would like to request that China's regulation not hamper foreign companies' activities or 
market access to China.  
4.328.   The representative of the United States  provided the following statement. The United States 
supports the statements of the EU and Ja pan. 
4.329.   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 principl e of non -discrimination, 
and treat all the organizations equally including foreign -invested enterprises that engage in 
commercial cryptography research, production, sales, service, importation and exportation, etc. The 
State encourages commercial cryptogra phy technical cooperation based on voluntary principle and 
commercial rules in the process of foreign investment. Administrative agencies and their staff are 
prohibited to force any transfer of commercial cryptography technology by means of administrative 
measures.  
4.1.3.36   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629  (ID 53971) 
4.330.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statements made during the previous regular meetings of the Committ ee 
on Technical Barriers to Trade and the Council for Trade in Goods on cobalt classification adopted 
under the 14th Adaptation to Technical Progress to the CLP Regulation and notified in the document 
G/TBT/N/EU/629 . The EU approved this classification in the absence of comprehensive  laboratory 
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 in a wide range of products. Additional step in this 
 
70 For previous statements follow the thread under ID 534 . 
71 For previous statements follow the thread under ID 539 . G/TBT/M/84  
 
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  direction is the Chemicals Strategy for Sustainability published by the European Commission in 
October 2020 that proposes imposition of a ban on the use of most harmful chemicals. Moreover, 
as a result o f stigmatization, even without further restrictions, cobalt and cobalt -containing products 
consumption will suffer due to deselection of these products by manufacturers of the final goods, 
such as, electric vehicles' batteries, energy storage units and sim ilar equipment critical to fight the 
climate change and achieve green sustainability. Although 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 inf orm the Committee on the state of work on bioelution? Finally, the Cobalt 
Institute initiated scientific study on carcinogenicity of cobalt metal for oral route of exposure. In 
this regard, we request that the European Union inform if all restrictions and prohibitions of cobalt 
use introduced following the implementation of the 14th ATP and the Chemicals Strategy for 
Sustainability will be lifted in case the carcinogenicity of cobalt for oral route of exposure will not be 
confirmed.  
4.331.   The representative of Brazil provided the following statement. Brazil supports STC 539 and 
is concerned with the trade impacts of the reclassification of cobalt as a carcinogenic level 1B. Cobalt 
is found in trace amounts in the production of nickel, and Brazil is the primary nic kel-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 
USD 12,350 million. Around 56% of the nickel m ine production in Brazil is at risk with limitations on 
the trade of cobalt. We thank the European Union for clarifying some central aspects of the regulation 
in past meetings of the TBT Committee and we look forward to continuing dialogue on this matter.  
4.332.   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 cobal t will become applicable as 
of 1 October 2021. As described in previous statements, the classification of cobalt is based on the 
independent scientific opinion of ECHA's Risk Assessment Committee (RAC), which takes into 
account all scientific information a vailable, including the information available in the dossier 
submitted by an EU member State (The Netherlands) and from the public consultation that is part 
of the process to arrive at an EU -wide harmonized classification. In addition, all comments sent to  
the TBT Committee by WTO Members were distributed to member States and they were duly taken 
into account by the European Commission and the member States in the decision -making process. 
Moreover, it should be taken into account that the Commission conside red that the method used to 
determine the Specific Concentration Limit of 0.01% should be assessed in order to discuss if the 
method is relevant for inorganic compounds like cobalt. For this reason, the entry in Annex VI to 
CLP for cobalt is without such s pecific limit and the generic limit of 0.1% will therefore be applied.  
4.333.   The EU would like to reiterate that, in line with the UN GHS (UN Globally Harmonized System 
of Classification and Labelling of Chemicals), the classification of any substance is based o n a hazard 
assessment and not on a risk assessment. It should be noted that classification under the CLP 
Regulation is based only on the scientific assessment of the hazards derived from the intrinsic 
properties of a substance and not on its uses, while po tential downstream legal or socio -economic 
considerations are not part of the principles for hazard classification. Nevertheless, the classification 
under the CLP Regulation does not in itself restrict the placing on the market of cobalt or cobalt -
containi ng products. When a substance is subject to harmonized classification, only labelling and 
packaging obligations are triggered for that substance and any mixture containing it, but not for 
articles (e.g. cutlery or other stainless steel articles). As previo usly announced, on the use of the 
bioelution method, the EU has made progress in the development of a harmonized approach at 
international level. The EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) 
Scientific Advisory Committee (ESA C) has given a positive opinion on the scientific validity of a 
bioelution test method. On the basis of this positive opinion, the method was proposed by the 
European Commission in November 2019 at OECD level for acceptance as a technical guideline. In 
May 2020 the OECD Working Group of the National Coordinators of the Test Guidelines Programme 
accepted the European Commission's proposal and an OECD subgroup has been set up to work on 
the technical guideline. This expert group met several times and made som e good progress, but 
discussions are still ongoing. The European Commission would welcome any support from third 
countries to actively participate in the development of the OECD test method on bioelution.  
4.334.   Relevant industries are already using the results o f 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 G/TBT/M/84  
 
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  classification but it is under the sole responsibility of the industry. Most probably, the companies 
producing metal alloys and compounds containing cobalt traces are using such bioelution data for 
classifying their alloys. However, as previously announced, in order to f urther examine this approach 
and to ensure a proper use of the experimental data obtained from the bioelution method, a 
European expert group has been created with the participation of experts of member States and 
metal industries. Two meetings of this sub -group have already taken place, in September 2020 and 
May 2021, and despite progress made in the last meeting, one additional is foreseen to finalize the 
discussion. With regard to the classification of cobalt as carcinogen for all routes of exposure, 
including the oral route, the EU would like to reiterate that the approach taken is in line with both 
the UN GHS and the CLP Regulation. In particular, the UN GHS stipulates the following in Table 
3.6.2: Label elements for carcinogenicity: "state route of exp osure 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 ca uses the hazard. A potential re -examination of the classification as regards 
routes of exposure can only be considered if new and relevant data from scientific studies, 
conclusively demonstrating the absence of carcinogenic effects from oral or dermal rout es of 
exposure, become available. As previously stated, in view of the time needed for such test results 
to become available, there was no scientific and legal justification to exclude the oral route. In case 
new scientific information becomes available in  the future, an amendment could only be envisaged 
following a revised Risk Assessment Committee (RAC) opinion.  
4.1.3.37   European Union - Organic production and labelling - Maté (erva -mate), 
G/TBT/N/EU/738  (ID 52472) 
4.335.   The representative of Brazil  provided the following statement. Brazil regrets  having to raise 
STC 524 after being consistently reassured by the EU that Regulation (EU) 2018/848 would come to 
force on 1 January 2021. Brazil had raised this STC for the last time in the TBT meeting of November 
2019, in which the European Union stresse d 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 Parliament 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 certain 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 th e entry into force of Regulation 
(EU) 2018/848 shows the EU's disregard towards the matters presented by Brazil under this long -
standing STC. As we have stated in previous meetings, not including erva -mate in the organic 
product list without any technical or scientific justification was discriminatory and more trade -
restrictive than 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 losses 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.  
4.336.   In response, the representative of the European Un ion provided the following statement. 
The European Union has replied to Brazil on this issue in previous TBT Committee meetings, as well 
as bilaterally. The new Regulation (EU) 2018/848 on organic production and labelling adopted on 
30 May 2018 by the Euro pean Parliament and the Council includes erva-mate under  its scope. The 
Regulation was due to enter 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 rule s on 
production, controls and trade. The EU notified to the TBT Committee a draft Regulation postponing 
the entry into application of the organics Regulation by one year ( G/TBT/N/EU/738 ). Regulation (EU) 
No 2020/1693 of 11 November 2020 amending Regulation (EU) 2018/848 on organic pr oduction 
and labelling of organic products as regards its date of application and certain other dates referred 
to in that Regulation was published in the Official Journal of the European Union on 13 November 
2020.73 Therefore, new organic rules will enter into application on 1 January 2022. From this date, 
erva-mate will be included in the scope of Regulation (EU) 2018/848, as it is listed in its Annex I.  
 
72 For previous statements follow the thread under ID 524 . 
73 OJ L 381, 13.11.2020 , p.1.  G/TBT/M/84  
 
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  4.1.3.38   Russian Federation - Federal law No 487 -FZ, providing a framework for 
comprehensive use of special labe lling 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 56774) 
4.337.   The representative 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 measure: 
individual labelling and registration creates significant burden and cost, well beyond the cost of the 
individual labels. This may be justified for some products of high value and with a high record of 
counterfeit or tax evasion, such as tobacco products or furs. Therefore the EU requests that Russia 
reviews the scope of products covered by the measure so that this focuses on high -value products 
for which there is evidence of a high level of counterfeit and/or tax avoidance. Though we commend 
the Russian government in its efforts t o tackle counterfeiting, this measure includes technical 
regulations and will have a significant impact on imports from the EU and from other WTO Members 
to Russia. According to the Decision of 1995 of the TBT Committee, "Members are obliged to notify 
all mandatory labelling requirements that are not based substantially on a relevant international 
standard and that may have a significant effect on the trade of other Members". Therefore, this 
measure should have been notified under the TBT Agreement before i ts adoption.  
4.338.   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 and needs to be notified to the WTO. In accordance with the TBT 
Agreement, sufficient time shall be provided to industry to adapt to the requirements necessary for 
placing products on the mark et of the Russian Federation, which is in general six months. Moreover, 
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 supplies 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 per iods. Producers/importers/retail and 
wholesalers of cheeses and ice cream have currently been indicating similar problems with regard 
to the date of 1 June 2021, i.e. they are not ready for labelling. Therefore, an extension of transition 
period is necessa ry, during which import and/or sale of non -labelled production to Russia would be 
allowed. This transition period should last at least until the end of 2021 and should cover all products 
for which labelling started in 2020 and those planned for 2021. Curre nt 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 (voluntary labelling), 1 June 
(obligatory for ice -cream and cheeses), 1 September 2021 (all products with a shelf -life of more 
than 40 days), 1 December 2021 (all products with a shelf -life of less than 40 days); Bottled water  
- pilot project until the end of May, obligatory labelling for mineral water as of 1 December 2021 
and all the rest of bottled water as of 1 March 2022; Beer - pilot started as of 1 April and will last 
until 31 August 2022.  
4.339.   The scheme will soon have been in operation for a year for certain categories of goods. The 
EU therefore wishes to enquire whether a regulatory evaluation is planned which weighs costs versus 
benefits of the implementation of the scheme so far. In accordance with good regulatory practic e, 
such evaluation is unavoidable before consideration of a possible extension of the labelling and 
tracing requirements to further categories of goods. We ask the Russian Federation to take into 
consideration the European Union's comments to ensure that t he implementation of this measure is 
not unnecessarily trade -restrictive, in accordance with the WTO TBT Agreement.  
4.340.   In response, the representative of the Russian Federation  provided the following statement. 
The objective of the Track and Trace System (T&T ) is to fight against circulation of illicit products as 
well as to ensure that taxes due are paid. The system is needed for law enforcement. No law -abiding 
company can compete with the one that is not paying taxes due. In this sense, the T&T  system is 
levelling the playing field and lawful companies benefit from it. We reiterate our position that T&T 
System does not meet the requirements for technical regulation set out in Annex 1 of the Agreement 
on Technical Barriers to Trade. This measure does not set r equirements for product characteristics 
and production methods as well as does not correspond to other elements of the technical regulation 
 
74 For previous statements follow the thread under ID 567 . G/TBT/M/84  
 
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  definition. In this regard, Russia does not intend to notify the measure to the WTO under the 
Agreement on TBT.  Russia does not consider T&T system disproportionate. The concept of the 
system in respect of each product category is developed together with the companies involved in 
manufacturing, imports and distribution of the respective products. 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 preceded by voluntary experiment with importers, 
manufacturers and representatives of foreign stakeholders in o rder to ensure system performance 
and adjust it to specificities of production and distribution process of each product. Also, transition 
periods for stocks are provided. All described steps allow interested companies to shape new 
requirements as well as t o prepare to them beforehand. As for dairy products mentioned by the EU 
today, we inform the WTO Members that preparation for implementation of the system with regard 
to this category of products was initiated two and a half years ago. All the companies in volved in 
manufacturing and distribution of milk products had an opportunity to participate in the pilot project. 
Most economic operators took part in preparatory work and now face no challenges. We are aware 
that certain dairy manufacturers are not prepar ed to comply with the legislation of the Russian 
Federation from 1 June 2021. To mitigate the situation , Government amended Resolution regulating  
T&T System in respect of milk products permitting products manufactured before 1 June to be 
marketed without d ata matrix codes after 1 June.  
4.1.3.39   Brazil - Draft Technical Resolution nº 69, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Composition, in Portuguese, in the Label of 
Personal Hygiene Products, Cosmetics and Perfumes, G/TBT/N/BRA/608,  
G/TBT/N/BRA/608/Add.1  (ID 44375) 
4.341.   The representative of Colombia  provided the following statement. Colombia reiterates its 
trade concern regarding various elements of Brazil's notification G/TBT/N/BRA/ 608/Add.1.  
Colombia's comments were sent through the contact point, and we have also submitte d them to the 
Brazilian authorities in various bilateral meetings. We welcome the willingness to address questions 
and comments in these discussion spaces.  The main concern is that ANVISA Resolution RDC No.  432 
of 2020 stipulates that the list of ingredien ts 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 translation 
into Portuguese of such a globally recognized nomenclature is an additional process and a one -off 
requirement, which has never been registered at the internatio nal 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 INCI international nomenclature for 
the declaration of in gredients has not created any health or problematic risk to the protection of 
human health and safety. It is therefore considered that there are no health grounds to justify the 
measure.  We remain committed to working with the authorities and industry on a n equally effective 
and less burdensome alternative to fulfil the legitimate objective invoked by Brazil.  
4.342.   The representative of Mexico  provided the following statement. This item continues to be of 
interest to us, and we therefore wish to place on the reco rd our support. Our concern remains, and 
we therefore ask for our statement from the previous Committee meeting to be reflected in the 
minutes.  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.  
4.343.   In response, the representative of Brazil  provided the following statement. RDC 432/2020 
establishes that personal hygiene product s, cosmetics and perfumes marketed in Brazil must have 
their chemical composition written in Portuguese in their labels. The regulatory process for the 
issuance of said regulation took place to ensure compliance with a final judicial decision from an 
appel late court in Brazil, against which no appeal can be filed. According to the decision, the National 
Health Agency (Anvisa) was obliged to edit a regulation that foresees mandatory description of the 
ingredients in Portuguese for the labelling of personal h ygiene products, cosmetics and perfumes. 
The judge asserted that the Brazilian Consumer Code requires that all product information must be 
presented in Portuguese, which was not observed in personal hygiene products, cosmetics and 
perfumes. Thus, the absen ce 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 
 
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  on the merit of the regulation notified as G/TBT/N/BRA/608 . Since then, as a party to the process, 
Anvisa pre sented 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 no menclature that 
provides greater transparency to customers, producers, and health professionals. Anvisa is aware 
that INCI is a nomenclature specially conceived for the substances and ingredients used in the 
production of cosmetic products, through a syste m based on scientific names and other Latin or 
English words, depending on their origin. It represents a code that covers the need to designate, in 
a clear, unique, and unequivocal way the labelling of cosmetic ingredients without distinguishing 
between la nguage 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.  
4.1.3.40   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 59476) 
4.344.   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, e specially now given the global health crisis 
we are facing. The one -year delay in implementation of the MDR to May 2021, provided some 
necessary relief. Likewise, the 11 January 2021 Commission Notice permitting remote audits by 
Notified Bodies (NBs) was a  welcome development. In acknowledging the significant obstacles that 
travel restrictions and quarantine orders pose to on -site audits during the pandemic, the temporary 
allowance of remote audits appears to be helping facilitate safe and timely product ap proval. We 
support the continued utilization of remote audits, if implemented consistently, to alleviate the 
assessment backlog and ultimately ensure patients' continued access to much needed medical 
devices and in vitro  diagnostic tools. However, several issues remain regarding implementation of 
both the MDR and IVDR, and US industry remains concerned about its continued access to the EU's 
USD 125 billion  medical device market, USD 20 billion of which is supplied by US products. In 
particular, we remain co ncerned about the number of NBs approved to assess conformity to the 
IVDR, with only four such NBs approved as of April 2021, and the effect this lack of testing capacity 
may have on continued implementation of the IVDR. Given the large number of products requiring 
testing under this regulatory framework and the relatively small number of approved NBs, has any 
serious thought been given to delaying the implementation of the IVDR or to considering other 
flexibilities such as expanding the grace period to pro ducts currently on the market?  
4.345.   We understand that CEN and CENELEC have accepted the Commission's standards mandate 
on 12 May just two weeks shy of the MDR being implemented. However, stakeholders remain 
concerned that the Commission intends to create harmo nized European standards to demonstrate 
compliance with EU legislation rather than use existing international standards. For example, the 
ISO standard for risk management is a foundational standard that is important to a range of devices. 
We understand tha t this international standard has been rejected as a means to demonstrate 
conformity under the MDR. Manufacturers will need to use EU regional standards that have yet to 
even be developed. We have heard similar concerns regarding the ISO standard for elect rical safety 
of devices which also applies to a wide range of medical devices – and specifically to life -saving 
COVID -related devices, such as ventilators. Can the EU explain its rationale for these deviations? 
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 authorities - especially given 
that we ar e in the midst of fighting a global pandemic.  
4.346.   We note that in preparation for the implementation of MDR, the Commission issued a 
guidance in January 2020, announcing it selected the Classificazione nazionale e internazionali 
(CND), a Unique Device Identifi er (UDI) system that is not harmonized with the well -established 
UDI system that utilizes the Global Medical Device Nomenclature (GMDN). GMDN was developed 
with the support of ISO and the then Global Harmonization Task Force (now the International Medical 
Device Regulators Forum) and is widely adopted by the medical device industry and used by over 
 
76 For previous statements follow the thread under ID 594 . G/TBT/M/84  
 
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  70 national medical device regulators to support their activity. We are concerned that the 
Commission's selection of CND will undermine the interoperability of t he 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 addressed interoperability concerns, 
and has not made any progress on map ping CND to GMDN so as to harmonize the UDI systems and 
reduce duplication for industry. 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. The EU has repeatedly stated in bilateral discussions and in published documents that 
it intends to map its nomenclature system to GMDN, but we have yet to see any action by EU that 
demonstrates any attempt to map to GMDN. In fact, the EU recently published its European Medical 
Device Nomenclature for public consultation but does not propose any steps toward mapping to 
GMDN. Could the EU explain w hat actions it is taking to map to GMDN?  
4.347.   The representative of Japan  provided the following statement. We appreciate the March 
update of the MDCG guidance development and publication plan. We request that MDCG guidance 
be published in accordance with this plan and transition period be established to comply with the 
guidance. We also would like to request EU to develop and make public the mapping of EMDN 
(European Medical Device Nomenclature) and GMDN (Global Medical Device Nomenclature). We 
have received ma ny reports from the companies undergoing technical document review that there 
has been no progress for a long period of time since the start of the review and the completion of 
the review and issuance of the Certificate by the MDR DOA are not foreseeable. In several cases, 
more than one year has passed since the start of the technical document review. We would like to 
request the regulatory authorities to investigate the causes of the prolonged technical document 
review by NBs and to explain how to take mea sures to improve the situation. The MDR requires 
strict clinical evaluation of Class I, IIa, and IIb medical devices, and we request that the regulatory 
authorities consider simplifying the clinical evaluation requirements for Class IIa, and IIb medical 
devices, similar to regulations in other countries such as 510(k) in the US and third -party certification 
in Japan, so that the MDR does not become more trade restrictive than necessary. The workload of 
NBs is still being focused on the MDR because the expir ation 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 are also requesting the prompt issuance of guidance documents for the IVDR and a 
timeline for their issuanc e as early as possible.  
4.348.   The representative of China  provided the following statement. China thanks the EU for the 
reply, but still remain concerned about the IVDR. We are looking forward to the consideration of and 
reply to our following concerns. Postpone  the transition deadline of IVDD and IVDR for two years. 
According to estimates, about 85% of the in vitro  diagnostic medical devices entering the EU must 
obtain a CE certificate after a technical documents review by a Notified Body, rather than adopting 
the form of "self -declaration". The proportion is only 15% in the case of IVDD. For a large number 
of in vitro  diagnostic devices that have obtained valid IVDD certificates, they still need to be re -
certified according to the requirements as new products. M anufacturers are facing 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 or updated the list of EU harmonized 
standards nor the more detailed c ertification guidelines, and no laboratory has been authorized by 
the EU as reference laboratory yet. Importantly, considering the pressure on national authorities of 
EU member States, notified bodies, manufacturers and other actors and the impact of COVID -19 
epidemic, it would be difficult for manufacturers to conduct tests in authorized laboratories and 
obtain certificates issued by the notified body in a timely manner. Manufacturers are unable to 
complete 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 preparation. Manufacturers need to 
consider the allocation of laboratory resources in advance while applying for product certification. 
As the EU has not announced any laboratories, and certification of high -risk products takes a 
relatively long time, manufacturers cannot choose the suitable laboratory configuration and optimize 
them, which will increase the difficulty of certification.  
4.349.   The representative of the Republic of Korea  provided the following statement. In line with 
the comments from other Members, Korea reiterates its concerns on the Medical Device Regulati on, 
which will likely have a significant impact on medical device exporters. Although the MDR entered 
into force as of 26 May, the concerns expressed by the Members in the last TBT meeting have not 
yet been fully addressed. In particular, the number of des ignated Notified Bodies, which is 20 under G/TBT/M/84  
 
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  MDR and 4 under IVDR, does not seem to be sufficient to review all the applications and 
accommodate the needs of medical device manufacturers that are waiting or expected to be 
authorized. In addition, even though  the regulation has already been implemented, the MDCG 
guidance is missing certain information such as post -market surveillance requirements, which could 
cause a great deal of inconvenience and confusion to manufacturers. For the above -mentioned 
reasons, K orea requests the EU to increase the number of designated NBs, extend the validity period 
of previously issued MDD certificates for a seamless transition towards MDR, and provide sufficient 
information and necessary guidelines to help manufacturers adapt t o the new regulation.  
4.350.   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 with the number of notified bodies and the rate of new approvals. There still appears to 
be insufficient capacity to carry out the certification and approval activities provided for in the 
regulations. We are also concerned that the creation of a European 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 vari ous 
regulatory jurisdictions. This new system being created in Europe is considered by industry to be a 
technical barrier to trade as another nomenclature system is being introduced. We are concerned 
the lack of harmonization and alignment could undermine the interoperability. Will this be 
reconsidered or will there be an exercise of mapping the new European codes to the current GMDN 
codes?  
4.351.   The representative of Singapore  provided the following statement. Singapore supports the 
concerns raised by the other Members on this specific trade concern. We wish to reiterate the 
concerns raised in our previous statement at the February 2021 TBT Committee meeting regarding 
the bottlenecks in the certification of medical devices, and the substantial challenges that the se 
bottlenecks pose towards continued access to the EU's medical device market. We look forward to 
further engaging the EU to find a mutually satisfactory solution on this matter.  
4.352.   In response, the representative of the European Union  provided the following  statement. 
The Medical Device Regulation officially entered into application on 26 May 2021. This new Regulation 
significantly improves and upgrades the regulatory system for medical devices, replacing the former 
two Directives. This change is not a cliff -hanger for CE compliant medical devices, as the grace 
mechanism, a similar but more stringent approach than grandfathering, foresees that valid Directive 
certificates can remain on the market until May 2025. The IVDR's corresponding date of application 
remains the same (26 May 2022). It has become evident that there are some delays in the 
preparation from parts of industry in view of the new requirements. The Commission continues to 
monitor the impact of these problems in order to avoid any shortages of de vices and is working 
closely with competent authorities, Notified Bodies and industry associations to continuously assess 
the situation and, if needed, identify solutions. Currently, we have 20 MDR designated Notified 
Bodies and 5 Notified Bodies under the  IVDR, with more following in the pipeline. In addition, and 
pursuant to a January 2021 Commission notice on audits and surveillance assessments under the 
MDR and IVDR, some more flexibility to member States to allow remote audits carried out by Notified 
Bodies, if the conditions set out within the notice are met, has been provided. Interesting to 
international partners is that of the Notified Bodies that also have a Medical Device Single Audit 
Program (MDSAP) designated auditing organization within their o rganization, 11 out of 13 have so 
far been designated under the MDR. These organizations cover some of the EU's trade partners such 
Australia, Brazil, Canada, Japan and the US.  
4.353.   It is important to underline that the EU does not expect to maintain the same n umber of 
Notified 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 adjus t and has in fact already done so, as the 24 
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. As regards 
implementation work, the Commission and member States are continuing work on implementing 
acts and guidelines. To date, there have been above 70 published guidance documents, including 
several key guidance on clinical requirements. On standardization, we are happy to report th at 
progress on this topic has been made and that preparatory work for the first publication of a set of 
harmonized standards under the new Regulations is currently underway. Furthermore, the expert 
panels, who have a role in the conformity assessment proce dures of certain high -risk products, are G/TBT/M/84  
 
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  officially running and processing applications. In addition, the registration module of the EUDAMED 
database was made available on December 2020 and the Unique Device Identification (UDI) 
registration module is fore seen to go live in September 2021. As reported in previous meetings, the 
other parts of the EUDAMED database will be made available in a gradual manner.  
4.354.   As regards the UDI, allow us to underline the fundamental difference between Unique Device 
Identificati on and the Nomenclature, which are two topics which seem to be confused in high -level 
discussions. While the UDI system employed in the EU is based on internationally agreed upon 
principles, the Nomenclature, also known as the language of use, will be diff erent. This was a decision 
which was taken after careful assessment and consideration. The EU would like to stress, once again, 
that the EU's choice for creating the European Medical Device Nomenclature was founded on the 
need for a sensibly structured nom enclature which is transparent, open, completely publicly 
accessible and downloadable for free. There are currently no other nomenclature systems offering 
those characteristics. It is important to clarify that the choice of this nomenclature does not 
const itute a barrier and to avoid misinformation and confusion in this respect. 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 n ew requirements to ensure trade 
continuity.  
4.1.3.41   Republic of Korea - Ballast Water Management Act (ID 60677) 
4.355.   The representative of the European Union  provided the following statement. The EU would 
like to recall its concerns raised at previous C ommittee  meeting s 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. EU industry has been in contact with the 
Korea Institute of Ocean Sc ience and Technology (KIOST) in order to finalize the requirements. 
However, the issuance of the Type Approval Certificate (TAC) has continued to remain elusive. It is 
our understanding that there are three open issues, which seem to be largely related to 
interpretation or clarification of results of already performed tests. Firstly, testing required by KIOST 
has already been approved by a globally -recognized classification society DNV GL, which, in its 
assessment, has applied the requirements as stated in the BWMS Code MEPC.300(72). The issue at 
hand lies in KIOST's interpretation of these requirements, which introduces an element of 
uncertainty in the certification procedure. Furthermore, testing required by KIOST has been 
conducted in 2019, which should s atisfy concerns raised regarding limitation levels. EU industry will 
send another report, issued by independent DNV GL, in order to close this matter. Secondly, as 
regards the validity verification of the shipboard testing, new reports have been submitted to KIOST. 
We hope these will be sufficient to satisfy KIOST's demands.  
4.356.   Thirdly, KIOST is requesting additional data to show that the preparation for the MPN 
analysis method was performed on -board despite the fact that this has already been confirmed in a 
previously submitted report from the independent lab that performed the necessary on -board 
testing. EU industry will send the newly requested information. Overall, it appears that the issuance 
of the certificate is being delayed by a non -willingness to acce pt interpretations of the BWMS Code 
made by other administrations and independent classification societies, and requiring more details 
that, in some cases, have already been provided. To underline, this ongoing certification procedure 
has taken more than t wo years in the Republic of Korea. By contrast, the same certification is 
automatic in one EU member State, when the testing is carried out by an approved Recognised 
Organisation (RO) such as DNV GL, or can require between three weeks and three months in o ther 
member States; even in other Asian countries, the procedure has only taken up to eight months. 
Therefore, the EU would like to emphasize the importance of a prompt issuance of the certificate 
and thanks the Republic of Korea for facilitating an earlie r reduction in the fee request.  
4.357.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea appreciates the interest of EU in Korea's Ballast Water Management Act. Korea would like to 
deliver the official response from the regulatory authority. As explained at various meetings such as 
the WTO and FTA meeti ngs, Korea 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, Korea would like to reiterate that Korea has no techni cal or institutional 
barriers to foreign products 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 
 
77 For previous statements follow the thread under ID 606 . G/TBT/M/84  
 
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  deliberation process (first round) was com pleted on 4 January 2021, and the Ministry of Oceans and 
Fisheries notified the company of the deliberation results. The company can obtain a type approval 
certificate by passing only a few tests with relaxed requirements. However, it has not yet completed  
such tests, having instead submitted related foreign government type approval data and technical 
materials on 3 March 2021. So, Korea carried out deliberation (second round) on the submitted data 
and materials and notified the company on 8 April 2021, tha t it is required to conduct only two 
seawater tests for the land -based test and validity verification for the shipboard test. However, the 
company submitted additional materials, which are currently under review, on 25 May 2021. Korea 
would like to inform the EU once again that Korea is affording equal treatment to domestic and 
foreign companies without imposing any technical or institutional barriers in terms of the type 
approval of the Ballast Water Management System. Regarding the data submitted by the E uropean 
company, we will complete the deliberation process as soon as possible and notify the company of 
the results. In addition, this delegation would like to inform you that any comments or enquiries will 
be received by the Ministry of Oceans and Fisher ies, which is the competent authority of Korea.  
4.1.3.42   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (ID 
60278) 
4.358.   The representative of the European Union  provided the following statement.  The European 
Union would like recall its conce rns with regard to the Qatar Ministry of Public Health Circular of 30 
May 2019 establishing import requirements for UHT milk and white cheese that entered into force 
the following day, on 1 June 2019. The EU regrets that Qatar did not notify these requirem ents to 
the WTO under neither the TBT nor the SPS Agreements. 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, that as cons equence cannot be exported to Qatar 
anymore. The EU is particularly concerned about the stringent restrictions on the shelf -life that 
disadvantage imported products in comparison to local products, but also about certain product 
characteristics for UHT mil k and white cheeses, in particular obligatory addition of vitamins to milk 
and low -fat-only requirement for certain 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 
necessary to fulfill 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. This measure has been in place for 
two years without any clarity provided by Qatar on when this measure will be lifted. The EU would 
like to invite Qatar to suspend the application of the measure without further delay, align it to the 
WTO r ules and comply with its notification obligations. The EU would like to thank Qatar for bilateral 
exchanges, which unfortunately have not yet resulted in an effective solution. The EU is prepared to 
continue work constructively with Qatar to resolve this i mportant issue.  
4.359.   The representative of Canada  provided the following statement. Canada joins 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 P ublic Health on 30 May 2019. While Qatar has provided 
assurances that the relevant measures apply equally to domestic and imported products, some 
exporting countries, such as Canada, are faced with logistical limitations that make it impossible to 
comply w ith Qatar's new 45 -day shelf -life requirements given the 50 -55 days of ocean transit from 
Canada to Qatar. As such, Canadian exporters of paneer cheese are unable comply with this new 
requirement. Canada remains concerned that Qatar's measure will effectiv ely favour domestic or 
close proximity sourcing of these products and limit imports of these products. Canada appreciates 
the responses Qatar provided on this issue in the context of its Trade Policy Review which took place 
in March 2021. However, details on how Qatar's new shelf -life requirements were established, 
including the scientific basis to support its approach, are lacking or remain unclear. Canada would 
encourage Qatar to share additional information in this regard. In closing and as stated in pre vious 
TBT Committee meetings, in light of Qatar's stated objective of ensuring the safety and quality of 
products sold in its market, Canada encourages 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.  
4.360.   The representative of the United States  provided the following statement. We regret we 
must once again raise concerns 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 
 
78 For previous statements follow the thread under ID 602 . G/TBT/M/84  
 
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  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 St ates participating in many bilateral 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. We have urged Qatar to suspend implementa tion of this measure 
until Qatar fulfills its WTO TBT transparency obligations for nearly two years with no response. If a 
determination is made to no longer raise this issue at future TBT Committee meetings, we emphasize 
this is not an indication we are n o longer concerned, or that Qatar has mitigated the measure 's 
impact on trade.  
4.361.   In response, the representative of Qatar  provided the following statement. Qatar has taken 
note of the continued concern of the European Union, Canada, and the US regarding Qata r's Ministry 
of Public health circular on shelf life for cheese and thanks them for their interest. We are still 
following this matter with the competent authorities in Doha, despite the lockdown imposed by the 
COVID -19 pandemic. We would like to take this  opportunity to reconfirm that these measures have 
been adopted to ensure the quality of products available in Qatar, and that the protection of 
consumers is of primary importance to the Government of the State of Qatar with its international 
obligations u nder the WTO Agreements, including the TBT Agreement. Also, we would like to assure 
Members that the relevant measures apply equally to domestic and imported products and are 
therefore non -discriminatory in nature. Furthermore, any impact that such regulat ions may have on 
trade will not be more than necessary to contribute to the fulfillment  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 significant effect on trade. This being said, we will share 
the concerns expressed today with our capital and will provide replies to the questions we have  
received as soon as possible. Also, we remain available to continue our constructive discussion with 
the interested Members to provide additional explanation where necessary.  
4.1.3.43   India - Air Conditioner and its related Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/110,  G/TBT/N/IND/74  (ID 59879) 
4.362.   The represe ntative of China  provided the following statement. At present, there are only six 
months before the implementation of Air conditioner QCO order on 1 January 2022. Under the 
current severe situation of the global epidemic, it is difficult for BIS to appoint  staff to conduct on -
site inspection to factories, which seriously affects enterprises' application for BIS certification. In 
this respect, China suggests that: Suspending the implementation of Air conditioner QCO order until 
the risk of certification acti vities is decreased. Using information and communication technology 
(ICT) to conduct remote video inspection to maintain compliance certification activities.  
4.363.   In response, the representative of India provided the following statement. Foreign inspection 
visits are on hold due to the prevalent restrictions on international travel imposed by the Government 
of India, but in some instances by the Government of other respective countries because of the 
ongoing COVID -19 pandemic. As soon as the situation of COVID -19 improves and the restriction 
lifted, India will plan the inspections (factory visit). There is no provision in BIS (Conformity 
Assessment) Regulations, 2018, for remote assessment or any other means for inspection.  
4.1.3.44   Kingdom of Saudi Arabia - Saber Conform ity Assessment Online Platform / 
Saleem Product Safety Program (ID 61580) 
4.364.   The representative of the United States  provided the following statement. The United States 
continues to reiterate its concerns regarding the conformity assessment procedures require d under 
the Saleem Saudi Product Safety program using the Saber system. Stakeholders continue to have a 
number of questions and concerns regarding this programme. To address at least some of the 
concerns from stakeholders, the United States requests that t he Kingdom of Saudi Arabia simplify 
the registration and certification process and implement clear and transparent guidelines. US 
industry reports that the HS codes on the Saber system, including those listed on Saber's website, 
often do not match internat ional HS codes. Can the Saudi Arabia Standards, Metrology, and Quality 
 
79 For previous statements follow the thread un der ID 598 . 
80 For previous statements follow the thread under ID 615 . G/TBT/M/84  
 
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  Organization (SASO) provide the list of products, using complete HS Codes having 10 digits, for 
which SASO will require third -party certification and new certificates of conformity inst ead of self -
declarations? US companies have indicated that their manufacturers and importers have been 
required to provide accreditation to ISO 17025, a standard for testing labs, as part of the certificate 
of conformity process. Requiring manufacturers an d importers that do not test at their facilities to 
provide accreditation to ISO 17025 for their facilities is overly burdensome. Would SASO remove 
this requirement for such manufacturers and importers, and also consider exempting such 
companies from this requirement if the third -party testing lab used is accredited by ILAC signatories 
for testing?  
4.365.   Industry stakeholders have requested that more detailed guidance be provided to Notified 
Bodies on how to implement the Saber platform for toys in order to incre ase efficiency of the system 
and to reduce compliance costs while ensuring consistency among Notified Bodies. Can SASO please 
update the guidance document for toys to allow for the following? Allow one GCTS QR code and one 
registration number for a group o f similar toys; limit the number  of documents and samples Notified 
Bodies need to review for GCTS "groups "; and define groupings broadly by type of toy, e.g. dolls, 
actions figures and their accessories, rather than by ten -digit HTS code; under or over thr ee years 
of age; and whether or not the toy contains a battery, with no limit on the number of Stock Keeping 
Units (SKUs) in a group. US exporters report that the process for conformity assessment differs 
among Notified Bodies in terms of the required test s and number of required samples. How is SASO 
working to ensure that all Notified Bodies implement the conformity assessment procedures in the 
same manner?  
4.366.   The representative of the European Union  provided the following statement. The European 
Union remain s concerned by the difficulties related to the implementation of the electronic 
certification system SALEEM through the web -portal SABER. While the European Union would like to 
thank the Kingdom of Saudi Arabia for engaging constructively in bilateral talk s 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 is particularly affected, but the system is being 
gradually extended to other produ cts, many of them exported by EU companies. While the 
conformity assessment requirements differ depending on the sector, several EU industries coincide 
in reporting their overly costly, burdensome and time -consuming nature in particular in view of the 
COVID-19 outbreak and the global crisis this has created. 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 Orga nisation (SASO). In particular, EU 
exporters report that such notified bodies continue to find new ways to increase costs when carrying 
out conformity assessment procedures.  
4.367.   The European Union would like to raise the following five points: With regard to r equest of 
test reports from the GCC Conformity Tracking Symbol (GCTS), we understand that Notified Bodies 
are requesting test reports in cases where test reports are not necessary. (Specifically for EN71 -9, 
which is not a harmonized standard providing pres umption of conformity with the EU Toy Safety 
Directive, and for phthalates, which is in many cases irrelevant). It would be useful to clarify with 
the Notified Bodies what are the legal requirements. On the selection of representative item, we 
welcome the "grouping approach". However, we understand that there are still issues when adding 
items to an existing group as Notified Bodies request samples of all products and also charge 
companies to select the representative items. We believe this is unnecessary a nd could be done 
based on pictures/documentation. On Saber, we would like to highlight a problem that the industry 
encountered for specific products. In the situation where a product is a toy according to the customs 
codes, but it is not a toy according to  the GSO technical regulation (for example because it is a 
product for older children/people), it seems impossible to proceed as there will be no GCTS awarded 
and this is a requirement in Saber. We believe it is mainly a technical/IT issue but still it has  an 
important negative impact as these products cannot be imported. We would like to highlight also an 
issue related to products imported without GCTS (GCC Conformity Tracking Symbol). We understand 
that a European company saw many of their products on the  market in Saudi Arabia without the 
GCTS. It seems the retailers have no link to them and in certain cases the manufacturer has not 
even obtained the GCTS for these products and is not able to import/sell these toys. It appears these 
products are imported without respecting the rules, which means there is no level -playing field and 
it can also reflect badly on the company. We would be interested in understanding how such a 
situation is possible and if you have any information in this regard. Finally, we wou ld like to have 
further information on SASO RoHS. We understand that electronic toys are in scope and the 
requirements for the conformity assessment procedure could be specifically problematic. It seems G/TBT/M/84  
 
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  that additional documentation or tests could be requi red for toys that already go through the GCTS 
and are also fully compliant with the EU Toy Safety Directive and EU RoHS. In this regards, we recall 
the importance and need to keep the conformity assessment requirements simple and without 
additional technic al documentation. In conclusion, the European Union would like to 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 discus s this issue with 
the Saudi authorities bilaterally.  
4.368.   The representative of Switzerland  provided the following statement. Switzerland reiterates 
its concerns over the potential impact of the Saber Conformity Assessment Online Platform on 
bilateral trade wit h the Kingdom of Saudi Arabia in a range of products. 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 carryi ng out conformity 
assessment procedures. 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 and registration is require d for the same low -risk products that already have been 
certified 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 
docum entation requirements which is prohibitive to enter the market. 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 requ irements are applied in an equal and 
uniform manner. Switzerland would further appreciate the publishing of all relevant regulations 
instituting the programme and outlining the scope of products coverage. The documentation and 
certification requirements, a s 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 S audi-Arabia 
could take these comments into account.  
4.369.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia would like to express appreciation for the concerns addressed by the United 
States, the Europe an Union and Switzerland regarding Saber Conformity Assessment Online 
Platform/Saleem Product Safety Program. SALEEM  programme works by developing integrated 
systems of regulations and standards that conform to internationally recognized professional 
practices by creating 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. 
Specifically,  essential requirements for human and animal health, environment protection, and to 
ensure the effectiveness of the services provided by legislative and regulatory bodies to achieve 
safety by the 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 1 -7 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 a UX design project to improve 
the importer's experience in registering their product and applying for their required certifications. 
We advise visiting the website below to find t he 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.81 
4.370.   The validity of the certificate is one year for the certification of conformity and three years 
for the Saudi quali ty mark and the G -Mark. However, the test report can be valid for three to five 
years if no change occurs in the production line or the product's composite. In Saber platform, clients 
can search by six digits and select from the results for the nearest des cription of their product. In 
terms of GSO toy regulation, GCTS tracking symbol must be issued through the GSO platform. Once 
the GCTS is obtained, the shipment certificates can be easily issued through the Saber platform. We 
strongly advise all toys indus tries 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 technic al 
regulations published by SASO. These technical regulations were developed to protect the consumer 
from high/medium risk products based on international best practices. The technical regulations can 
be found on the official website of SASO via below link .82 Please note that Saudi Customs is the 
 
81 https://saber.sa/home/hscodes   
82 http://www.saso.gov.sa/en/laws -and-regulations/technical_regulations/pages/default.aspx   G/TBT/M/84  
 
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  entity responsible for the HS code, and we recommend visiting their website to find the right HS 
code that matches the product description.  
4.371.   SASO is committed to reviewing some details of these conformity assessment  procedures 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 accordance with the international 
standard ISO/IEC 17065 set this require ment 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 (in addition to being an accredited laboratory) must be certified by 
SASO  to be able to issue test reports for energy efficiency products. The conformity assessment 
procedures done by a manufacturer differ from those done by an importer. This is explained in 
Article  18 of the GSO toys regulation and detailed  in appendix 4 and 5  of the regulation. Therefore, 
the certificate and GCTS 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. Finally, 
SASO audits the conformity asse ssment procedures and requirement to ensure fair trade.  
4.1.3.45   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9 , G/TBT/N/MEX/178/Add.10 , 
G/TBT/N/MEX/178/Add.11 , G/TBT/N/MEX/ 178/Add.13 , G/TBT/N/MEX/46 8 (ID 60883) 
4.372.   The representative of Costa Rica  provided the following statement. Costa Rica maintains its 
trade concern regarding Mexico's proposed front -of-pack nutrition labelling for food products.  In 
recent years, Costa Rica has very much believed in, a nd defended, the importance of the work 
carried out within the Codex Alimentarius framework, and has given equal importance to scientific 
justification for the measures adopted by each country, whether they be based on the Codex itself 
or on other technica l or scientific evidence, as required by the Agreement on Technical Barriers to 
Trade. Given that the Codex Alimentarius is currently developing working materials on front -of-pack 
nutrition labelling, Costa Rica wishes to request once again that the Mexica n delegation clarify 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 for Mexico to 
indicate the scientific basis or in ternational reference standard used to define the key parameters of 
the standard in question, including providing relevant justification for the use of the front -of-pack 
warning sign as supplementary nutritional information, and the scientific basis for se tting 
classification parameters according to which a product is considered to contain excessive calories, 
sugar, saturated fats, trans fats or sodium, given that they are not Codex -based.  
4.373.   Turning to the consumption by children of products containing added caffeine or sugar 
substitutes, Costa Rica requests the delegation of Mexico to refer to either the international reference 
standard used or the risk analysis establishing the risk posed to children by the consumption of 
products containing these ingredient s. Costa Rica believes that the measure adopted by Mexico could 
generate inconsistencies with TBT Agreement obligations, in particular those established in Articles 
2.2 and 2.4.  Costa Rica maintains its view in this Committee that, as things currently stan d 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 international 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 provide 
information about th e status of this draft Amendment.  
4.374.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
support for this item and its concern regarding this regulation, refers to its previous statements and 
asks for them to be included in the minutes of the 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 concern of other countries o ver the mandatory 
declaration of added sugar, which is not provided for under Codex guidelines. Also, it concerns 
Paraguay that no analytical method can differentiate between total sugar and sugar added to a food, 
thus complicating taxation, as it would de pend on the information provided by industry.  The 
 
83 For previous statements follow the thread under ID 608 . G/TBT/M/84  
 
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  nutritional labelling's lack of harmonization with international guidelines could impede trade between 
countries.  
4.375.   The representative of Guatemala  provided the following statement. We recognize Mexico's 
right to protect people 's health and to provide consumers with information on the food they buy. We 
thank Mexico for the response it provided during the previous meeting, which was endorsed in the 
report of the meeting, in particular its indication that there is no expiry date as a permanent 
mechanism in the use of a supplementary label. Guatemala would like to ask whether the 
Government of Mexico will issue a Technical Regulation explicitly stating this, as the Agreement 
published on 1 October 2020 still has t ransitional provisions at the end of the publication. The first 
one clearly states that it will enter into force on 1 April 2021 and expressly excludes the use of 
supplementary labels on front -of-pack labelling.  We recall that CODEX CXS 1 -1985, General 
Standard for the Labelling of Pre -packaged Foods, authorizes the use of a supplementary label which 
fully and accurately reflects the information contained on the original label.  
4.376.   In response, the representative of Mexico  provided the following statement. The delegation 
of Mexico is participating actively in the front -of-pack labelling standard -setting work through the 
Codex Alimentarius. However, the lack of an international standard on the subject at this time does 
not prevent a Member from issuing Technical Regulations on front -of-pack labelling on pre -packed 
foods and non -alcoholic beverages in order to protect its legitimate public interest objectives.  We 
would also clarify that the technical and scientific evidence supporting the amendment to Mexican 
Official Standard NOM -051-SCFI/SSA1 -2010 is available in the bibliography chapter for consultation 
by any interested party.  Regarding the questions on this measure, we invite those concerned to 
consult the information that was provided in previous Committee dis cussions and reflected in the 
minutes contained in documents G/TBT/M/80 , G/TBT/M/81 , G/TBT/M/82  and G/TBT/M/83 . In 
addition, it would be p articularly relevant to recall that the Government of Mexico granted a period 
from 1 April to 31 May 2021 for the marketing of products without penalty if they only complied with 
the new front -of-pack labelling system on their labels, and not with other co mmercial and health 
information that came into force on 1 April 2021. This was so as to recognize the need for stock 
turnover of products that were already at the final point of sale to the consumer before 1 April 2021.  
The delegation of Mexico reiterates its willingness to clarify any doubts that the Members of this 
Committee may have on the implementation of this Technical Regulation. Such concerns may be 
sent in writing via the WTO contact point.  
4.1.3.46   India – Toys (Quality Control) Order, 2020 (IND/131); Amen dment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(IND/143), G/TBT/N/IND/131,  G/TBT/N/IND/143  (ID 63284) 
4.377.   The representative of the European Union  provided the following statement. The European 
Union is concerned about India's Toys Quality Control Order 2020 ( QCO), and the Amendment in 
Policy Condition No. 2(ii) 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. The E U would like to reiterate its strong concern in relation to the 
Quality Control Order and in particular to the certification requirements introduced by the Bureau of 
Indian Standards (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 a standstill. The 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 regulatory order and BIS auditors have audited domestic 
facilities, the same cann ot be said for plants in third countries. EU companies already adhere to the 
strictest quality and safety standards, and 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.  
4.378.   However, as a result of the prevailing pandemic -related travel restrictions, BIS auditors have 
not responded to applications and reque sts 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. Second ly, despite 
 
84 For previous statements follow the thread under ID 632 . G/TBT/M/84  
 
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  fulfilling the requirements laid out by the Quality Control Order there is no way for European 
companies to comply, as exports to India require in -person audits by BIS, which are not yet possible 
in the current context. It is difficult to envis age BIS auditors travelling to foreign plants in these 
conditions. As previously suggested, the EU would therefore request India to allow third -party audits 
or virtual audits of third country factories (such flexibility is allowed for domestic manufacturer s). 
We understand that the Indian Government is considering virtual audits and we would appreciate 
further details in this regard. In the meanwhile, it could be helpful to allow imports of toys, under 
the continued enforcement of the DGFT system with Custo ms continuing testing imports for 
conformity with applicable Indian Standards by NABL accredited labs (as per DGFT Notification 
33/2015 -20). Without these alternatives, European companies do not have a fair chance of being 
able to satisfy their existing co nsumer 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 raised by the EU.  
4.379.   The representative of China  provided  the following statement. It is suggested that India fully 
consider the requirements which will cause repeated testing and charges in the toy import policy 
and simplify Customs clearance procedures. India's current toy import policy requires each 
consignme nt of toys to be sampled for testing and charged, and the certification rules in the QCO 
also require each series of toys to be tested and charged. According to the test price stipulated by 
the BIS, sample testing (per sample) is charged about $150, which means that the testing cost of a 
toy exported to India by a foreign toy manufacturer is about $300. China believes that the current 
Toy Import Policy and the certification rules in the QCO impose repeated testing and charges on the 
same type of imported to ys, which increases the economic burden and Customs  clearance time of 
foreign manufacturers. According to Article 5.1.2 of TBT Agreement, China kindly requests India to 
fully consider the concern that repeated testing and charging in the QCO and DGFT Notif ication 
No. 33/2015 -20 which lead to a significant increase in costs of toy enterprises exporting to India, to 
simplify Customs clearance procedures and shorten Customs clearance time. Due to the huge dual 
demand for toy certification testing and import te sting in short term, it is suggested to exempt 
imported toys from testing, enlarge the lists of third -party labs and accept their testing results. Both 
the QCO and Import Policy require samples to be sent to NABL accredited labs for testing or 
sampling. Am ong the 29 labs accredited by NABL at present, less than 10 labs can meet IS 9873 
and IS 15644 standards at the same time and operate normally, therefore it is difficult to meet the 
huge dual needs of certification testing and import testing, affecting the  testing efficiency. According 
to Article 5.2.1 of TBT Agreement, it is suggested that India exempt the import toys with the 
Standard Mark from testing in a certain period of time for the purpose of saving testing resources 
and speed -up of certification, a nd enlarge the lists of third -party labs in Schedule -II of Indian Bureau 
of Standards (Conformity Assessment) Regulations 2018 stipulated in Article 3 of the QCO to include 
NABL accredited labs and all ILAC -accredited labs, and accept the results of foreig n labs accredited 
by ILAC.  
4.380.   It is recommended that India cancel the factory testing facilities requirements for all items 
such as electrical toys testing. In October 2020, BIS published the procedure of "10 steps to BIS 
Licence for Toys" on its official web site as the implementation rules of the Toys (Quality Control) 
Order, 2020. Step 4 in the new procedure stipulates that factories producing electronic toys need to 
be equipped with the testing facilities and instruments for the requirements of clause 8,9,1 0 in 
IS 15644:2006. However, these testing facilities are relatively expensive and highly technically 
demanding, making it difficult for small and medium -sized enterprises. And these tests usually need 
to be completed by third -party labs outside. Requiring  the factory of toys to set up these testing 
facilities is unnecessary and unreasonable. According to Article 5.1.2 of the TBT Agreement, it is 
recommended that the India cancel the factory testing facilities requirements on all items such as 
electrical to ys. It is recommended that India adopt the currently -used international remote video 
censorship or other ways to solve the certification as soon as possible. Under the context of the 
COVID -19 pandemic, BIS auditors are unable to carry out the on -site inspe ction on foreign toy 
manufacturers, which make foreign toy manufacturers unable to export toys to India without the 
certification. It is suggested that India adopt the currently -used international remote video 
censorship or other ways to solve the certific ation problem as soon as possible.  
4.381.   The representative of Canada  provided the following statement. While Canada appreciates 
the importance of toy safety, Canada continues to be concerned by the increasingly restrictive toy 
measures India is putting in place  which, in Canada's view, are not improving the safety of the 
Canadian toys exported to India. We continue to seek responses to the written questions that Canada 
sent to India in April 2020, and which raised the following concerns: the need for in -country product G/TBT/M/84  
 
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  testing; the failure to use international standards; requirements to nominate and retain an in -
country Indian representative; the need to provide a performance bank guarantee; and the value of 
providing an indemnity bond. Moreover, Canada continues  to seek the cessation of the Quality 
Control Order that requires Indian officials to conduct inspections of toy factories in exporting 
countries, at the exporters expense. Owing to COVID -related travel restrictions, these inspections 
cannot be undertaken and, consequently, Indian imports have stopped. We recognize the constraints 
that the COVID -19 pandemic is currently placing on India, but, at a minimum, Canada is urging 
India to consider conducting virtual inspections of foreign toy manufacturing plants to attest their 
safety.  
4.382.   The representative of Hong Kong, China  provided the following statement. Hong Kong, China 
would like to thank the European Union and China for raising this specific trade concern, to which 
we would like to add our support. Hong Kong , China is concerned about the entry into force of India's 
measure, namely the Toys (Quality Control) Order, 2020 (the Order), and the Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 -Schedule -I (Import Policy), with effect from 
1 January 2021. On the bilateral and capital level, Hong Kong, China already outlined to India on 
19 March 2021 the concerns raised by our toy manufacturers and exporters. So far, we have not yet 
received any feedback from India. To recap, the toy manufacture rs and exporters in Hong Kong, 
China are concerned about the new requirement for physical inspections of overseas factories by 
officials from the Bureau of Indian Standards (BIS) and the requirement for factory audits by 
designated Indian firms. Under the travel restrictions arising from the COVID -19 pandemic, it is 
uncertain whether the required physical inspection by BIS officials can be performed in a timely 
manner. The toy manufacturers and exporters in Hong Kong, China also note that only a few of the 
accredited laboratories responsible for the testing of toys are operating normally in India during the 
pandemic. In addition, there are costs associated with obtaining the licences and the Standard Mark, 
including visiting charges, testing charges, other a dministrative costs for processing of application 
by the BIS, the need to print the Standard Mark on the primary packaging, etc.; such costs will 
create financial burden and undue obstacles to non -Indian toy manufacturers and exporters. We 
understand that the export of toys to India by toy manufacturers and exporters in Hong Kong, China 
have come to a standstill due to the new requirements under the Order. Hong Kong, China is 
committed to resolving this issue with India amicably. While we recognize the impo rtance of 
upholding the safety standard of toy products, we respectfully request India to critically reassess 
the new measures imposed under the Order  and consider alternative solutions, so as to provide a 
level playing field for foreign manufacturers and exporters. Hong Kong, China looks forward to 
receiving India's early response to the concerns raised by our toy manufacturers and exporters.  
4.383.   In response, the representative of India provided the following statement. Foreign inspection 
visits are on hold du e to the prevalent restrictions on international travel imposed by the Government 
of India, but in some instances by the Government of other respective countries because of the 
ongoing COVID -19 pandemic. As soon as the situation of COVID -19 improves and th e restriction 
lifted, India will plan the inspections (factory visit). BIS has recognized a number of laboratories for 
carrying out toys testing as per various parts of IS 9873 and IS 15644 (Safety of Electrical Toys). 
All of these laboratories are current ly running normally. The IS wise list of recognized laboratories 
is dynamically updated and is available on the BIS website at the below link.85 Department for 
Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry has issued 
the Toys (Quality Control) Order, 2020 under the provisions of BIS Act, 2016 and Rules and 
Regulations framed thereunder, which envisages conformity assessment scheme -I of BIS 
(Conformity Assessment) regulations, 2018. As per Scheme I of Schedule II of BIS (Conformity 
Assessment) Regulations, 2018, the applicant must submit a complete test report of the product 
issued from a third -party laboratory and the application. The testing of sample drawn during the 
factory inspection is also carried out in a third -party laboratory. Under Scheme -I, a third -party 
laboratory is defined as "a laboratory established, maintained or recognized by the Bureau or 
Government laboratories empanelled by the Bureau or any other laboratory decided by the Bureau's 
Executive Committee ". 
4.384.   As regard marking and labelling requirement, it may be mentioned that under the Scheme -
I, BIS licence will be granted to a manufacturer of toys as per the Indian Standard and all varieties 
(maybe called items/families /models/SKU etc.) of toys covered i n the standard will get covered 
under the same licence. No separate application and standard mark are required to cover families 
of similar toys. Further, to cover all the varieties in a standard under the licence, BIS will be issuing 
 
85 http://164.100.105.198:8096/bis_access/iswise_v2.html   G/TBT/M/84  
 
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  grouping guidelines i ntending to specify a minimum number of varieties of toys to be tested to 
consider covering a larger number of varieties in the scope of the licence. This will be with the aim 
of optimum testing to ensure the safety of all toys for children. The marking of  standard mark 
concerning standard and licence number is a requirement as per the provision of BIS (Conformity 
Assessment) Regulations and applies to all manufacturers in India as well. The standard mark is 
essential for the common consumer to understand a nd identify that product is certified and safe to 
use. This is already in practice for more than 200 products under mandatory certification and being 
implemented by more than 1,000 manufacturers of various countries under the FMCS scheme of 
BIS. As per the  Toys (Quality Control) Order, 2020, every toy shall conform to corresponding Indian 
Standards specified therein and shall bear the standard mark under the licence from BIS as per 
Scheme -I of BIS (Conformity Assessment) Regulations, 2018. Under the provisi ons of Scheme -I, 
BIS grants a licence to use or apply Standard Mark (ISI mark) on goods and articles as per Indian 
Standard and not as per International Standards. IS 9873 (Part 1,2,3,4 & 7), specified in the QCO, 
are identical with International Standard ISO 8124 (Part 1,2,3,4 & 7). Part (9) of IS 9873 is an 
indigenous standard published to restrict certain phthalates esters in toys and children products. 
However, the test method used is identical to ISO Standard. Further, IS 15644 is also identical with 
International Standard IEC 62115.  
4.1.3.47   Australia - Maturation requirements for imported alcohol (ID 63686) 
4.385.   The representative of Brazil  provided the following statement. Brazil continues to follow 
closely Australia's proposal to amend current regulations dealing  with alcoholic beverages. In past 
Committee meetings, we have shared our concerns with Australian technical requirements applicable 
to cachaça, the Australian Customs Notice Nº 2007/19, which requires that some alcoholic beverages 
must be matured in wood for a minimum of two years before delivery from Customs control. This 
covers all beverages under tariff classifications 2208.20.10, 2208.30.00 and 2208.40.00. Even 
though said Notice  only refers directly to brandy, rum, and whisky, it encompasses tariff li ne 
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 
government does not allow imports of cachaça that a re 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. Following a public consultation in late 2019, the Australian Border Force (ABF) further 
explored a potent ial 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 consu ltation, 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 
exempt from this maturation requirement. The pro posed list of exempt products would include 
Cachaça and Pisco and Bourbon.  
4.386.   Brazil acknowledges progress in the course of action proposed in the last public consultation. 
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 brandy, whiskey or rum to be imported into the Australian market. In order to avoid 
any confusion in the Australian market or among Aus tralian 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". We kindly urge Australia to answer the following questions, 
which have no t been addressed in its previous statements. Could Australia please confirm if this new 
regulation will also establish new labelling requirements for products other than rum, brandy and 
whisky? Could Australia provide timeframes for the publication of the final text? Could Australia 
indicate why it has not notified said public consultations to the TBT Committee?  
4.387.   In response, the representative of Australia  provided the following statement. We thank 
Brazil for its interest in Australia's review of maturation  requirements for imported alcohol and 
provide the following update to the matter raised by Brazil. Australia applies equivalent requirements 
on domestic manufactured products and imported products that are classified as whisky, brandy or 
rum to be matured  in wood for a period of at least two years. These requirements are applied through 
the Excise Act 1901 and Customs Act 1901 (Customs Act) respectively. Australia is continuing to 
review its legislative framework for the importation of unmatured alcohol pr oducts under section 
105A of the Customs Act. The review process is considering potential options for treating unmatured 
 
86 For previous statements follow the t hread under ID 636 . G/TBT/M/84  
 
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  spirits without undermining Australia's consistent approach to maturation requirements. In 
November 2020, the Australian Government und ertook 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 Act. The consultation paper was provided directly to the participants of the 
previous consulta tion sessions, including the Brazilian Embassy in Canberra and is available on the 
Department of Home Affairs Website.87 The Government is considering potential reforms following 
the outcome of this consultation. Any proposed changes will be notified to th e Committee in 
accordance with our obligations under the TBT Agreement. Australia acknowledges Brazil's 
engagement on the review of Australia's maturation requirements for alcohol. Representatives from 
the Brazilian Embassy participated in both the 2019 an d 2020 consultation processes, led by the 
Australian Border Force (ABF). The ABF is taking the issues raised by Brazil into consideration as 
part of the ongoing reform process.  
4.1.3.48   India – FSSAI's Food Safety and Standards (Food Products Standards and Food 
Additives) Regulations, 2011 and the new implementing veterinary certificate for dairy 
products (ID 63388) 
4.388.   The representative of the European Union  provided the following statement.  India has in 
December 2019 adopted a new veterinary import certificate for m ilk 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, which app lies equally to both domestic and imported foods " (as reflected 
in the notification G/SPS/N/IND/236) . It was however still possible for cheese containing animal 
rennet to access the Indian market provided that it was correctly labelled. The new veterinary 
certificate requires that milk products have not been manufactured using animal rennet. As most 
European cheese is traditionally made with animal rennet, this means that there is a de facto  ban 
for European cheese entering the Indian market. Similar difficulties arise for cheese by -products, 
such as whey and lactose. While the EU fully supports the impor tance 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 certificates are to address sanitary (human or animal) health issues. 
There is no scientifi c 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.  
4.389.   In response, the representative of India provided the following statement. The provisio n for 
non-animal rennet in the manufacture of cheeses is not newly introduced in our regulations. 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. During 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. The requirement of a veterinary certificate has been recently aligned with our 
FSSR regardi ng the prohibition on the use of animal rennet. 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. Hence, FSSAI has not introduced 
any new requirement.  
4.1.3.49   India - Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65189) 
4.390.   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 order originally 
should have entered int o force on 1 January 2021 and has been postponed to 1 March 2021. The EU 
shares India's food safety concerns. However, we would like to highlight the following concerns. The  
criteria for the selection of the 24 food crops listed in Annexure 1 is not clear.  The EU invites India 
to explain the rationale behind such selection. Non -GM origin cum GM -free certification per 
consignment should not be required, at least for the listed crops for which no GMOs are authorized 
 
87 www.homeaffairs.gov.au/reports -and-publicati ons/submissions -and-discussion -papers   
88 For previous statements follow the thread under ID 633 . 
89 For previous statements follow the thread under ID 651 . G/TBT/M/84  
 
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  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 an official statement to 
India on the non -GM nature of the crops concerned, which would replace individual certificates for 
each consignment. For listed crops for which GM varieties are authorized in the exporting country 
(for the EU, this applies to maize, soybean, cotton, Argentina canola, and sugar beet) a requirement 
to produce a certificate for every consignment is not justified. Such a burdensome 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 GM requirements by the EU.  
4.391.   India should explain why they consider it necessary to impose such a burden on trading 
partners with a high prev alence of non -GM food on their domestic market and a robust regulatory 
regime governing the use of GMs. The EU underlines 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, t here are very 
strict traceability and labelling requirements applicable to food that contains GMOs. This allows a 
strict and effective separation between non -GM and GM products, with the exception of those 
containing GM ingredients in a proportion of less than 0.9%, provided the presence is adventitious 
or technically unavoidable. This means that the EU's tolerance limit is even stricter than that 
indicated by FSSAI in its clarification dated 8 February 2021, i.e. 1%. All authorized GMOs in the EU 
are regis tered in the publicly available EU GM register, which is managed and regularly updated by 
the EU Commission. The EU as well as India are both parties to the Cartagena Protocol on Biosafety  
to the Convention on Biological Diversity. To ensure coherent imple mentation 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 acc ompany 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 existing 
EU regulatory provisions already offer satisfactory assurance that EU produce exported to India is in 
compliance with Indian's requirements. The Indian requ irement, imposing non -GM origin cum GM 
free certification for all consignments of the listed crops, goes beyond what is necessary to achieve 
the stated objective and puts an additional burden, and therefore costs, on EU exporters (and the 
related operators  along the supply chain). Therefore, the EU considers that the Order is 
disproportionate and creates unjustified barriers to trade. The EU would be grateful if the above -
mentioned comments could be taken into account and replied to.  
4.392.   The representative of t he United States  provided the following statement. The United States 
again reiterates serious concerns with India's measure mandating "non-GM (genetically modified) 
origin and GM free certificates " for certain agricultural imports into India, notified on 2  September 
2020, as G/TBT/ N/IND/168 , and a later notified entry -into-force date of 1 March 2021. The United 
States would like to remind India of our previous statements delivered at the October 2020 and 
March 2021 TBT Committee meetings, which detailed our continued concerns regard ing India's 
implementation of this measure. The United States urges India to withdraw this requirement, for 
which India has not provided science -based justification despite multiple US requests. India should 
explain the scientific rationale for the measure  and provide any relevant international standards on 
which this measure is based. If India is unable to withdraw this requirement, we request that India 
consider alternative approaches that are implemented in a non -discriminatory manner, and in a way 
that is no more trade -restrictive than necessary. In January 2021, the US proposed technical 
cooperation with India to develop alternatives to the non -GM origin and GM -free certificate. We look 
forward to the Food Safety and Standards Authority of India's (FSSA I) response to this proposed 
technical cooperation opportunity.  
4.393.   The representative of Brazil  provided the following statement. Since India has not yet 
provided any explanation on the points raised by Members regarding STC 651 in the past Committee 
meetings , Brazil would like to reiterate its concerns. Brazil strongly supports the 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 imported food consignments, notified as G/TBT/N/IND/168 . This regulation applies 
to 24 crops and requires official certification to attest that imported products are not genetically 
modified. Besides, certification must be issued for each cargo individually. The text of the regulation 
presents a template for the certificate to be issued by the competent authority of each country. India G/TBT/M/84  
 
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  has not yet published any regulatory impact assessment, risk analysis, or technical document that 
presents the link between said regulation and the legitimate objectives it is willing to safeguard. The 
lack of information regarding the scientific grounds for this regulation raises concerns about 
transparency in the regulatory process undertaken by Indian authorities. Neither has India explained 
how this regulation relates to any relevant international standards for food safety and GMOs, 
differing from obligations set under Article 5.1.2 of the TBT Agreement. Said regulation might be 
already impacting Brazi lian exporters.  
4.394.   The Indian regulation is particularly harmful to Brazilian exporters of apples, cowpea beans, 
tobacco, sugar cane, and corn. Besides, the order establishes overly burdensome requirements for 
the so -called Competent National Authority, which  would have to issue a certificate for every single 
consignment of the food products listed in the Annex. Despite providing a period for comments, the 
Indian government has already set a date for entry into force of the regulation (1 January 2021), 
which r aises 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 fulfill any legitimate 
objective under the scope of the TBT Agreement. We kindly ask India to reassess this draft measure. 
Moreover, could India please indicate the studies and t he relevant international studies it relied upon 
in order to draft this regulation?  
4.395.   The representative of Colombia  provided the following statement. Colombia supports this 
trade concern regarding the Order adopted on 12  October  2020 by the Food Safety and Standards 
Authority of India (FSSAI), 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 (GMOs). The certificate must be issue d by the relevant national authority of the exporting 
country.  At this time there is no clarity with respect to the legitimate objective pursued by India, its 
scope, products covered or the requirements for market access. Similarly, the 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 becom e an unnecessary obstacle to trade, 
violating Article 2.2 of the TBT Agreement, which states that, "(...) Members shall ensure that 
technical regulations are not prepared, adopted or applied with a view to or with the effect of creating 
unnecessary obstacl es to international trade".  We request India to provide information on the entry 
into force of this regulation, on which matter we reiterate that a reasonable interval should be 
allowed between the publication of technical regulations and their entry into force, in order to allow 
time for exporters, and particularly in developing countries, to adapt their products or production 
methods to the requirements of the importing Member.  We request India to revise this regulation, 
consider alternative ways to avoid  the creation of unnecessary obstacles to international trade and 
to re-submit the notification of the regulation in order to have access to the relevant information.  
4.396.   The representative of Japan  provided the following statement. Japan shares the concerns o n 
India's 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 Member countries. Despite our request to consider the 
comments and concerns from Member countri es to India, it is very regrettable that the order has 
come to effect this March. Japan controls the import, distribution, and cultivation of GM food through 
the safety assessment conducted under the Japanese domestic regulation The non -approved GM 
variety  cannot be imported to Japan or distributed domestically. India's requirement to attach the 
"non-GM origin and GM free certificates " to the specific food items which are already appropriately 
controlled in the exporting countries is unnecessary and excessi ve measure. Thus, Japan would like 
India to waive the requirement to attach the certificate for such controlled food items from Member 
countries.  
4.397.   The representative of Australia  provided the following statement. Australia thanks India for 
their ongoing eng agement and cooperation regarding the use of non -GM with GM -free certificates - 
in particular India's response to queries on this item raised during both the WTO SPS and TBT 
Committee meetings earlier this year. 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 emphasise the importance of compliance with WTO obligations, in 
particular the requirements that measures be implemen ted in a non -discriminatory manner and in G/TBT/M/84  
 
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  a way that is no more trade -restrictive than necessary. Australia looks forward to India's continued 
engagement on this issue.  
4.398.   The representative of Paraguay  provided the following statement. Paraguay reiterates it s 
position and refers to its statement made at the previous meeting90, in which it stated the technical 
reasons for which it considers that the regulation contained in notification G/TBT/N/IND/168  could 
be more trade -restrictive than necessary to fulfill any legitimate objective un der the TBT Agreement.  
We hope that India revises this measure to address our concerns and those of many other Members, 
as expressed to this Committee.  
4.399.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns r aised at the October 2020 and February 2021 TBT Committee Meetings regarding 
the implementation of India's August 2020 Order, notified to the TBT Committee under 
G/TBT/N/IND/168 , which mandates that a non -genetically modified or GM -free certificate 
accompany imported consignments o f 24 imported food products listed in the Order's  Annex I. While 
we understand India's commitment to ensure the health and safety of its population, it is unclear 
how India's non -GM certification requirement will fulfill its intended objective given the la ck 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 f ood 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 India's Order disproportionately 
impacts the ability of GM -producing countries to export to India and unnecessarily restricts 
international trade. We strongly encourage India to consider the scientific and technical information 
in support of a less burdensome approach to meeting the Order's stated food safety goals . Therefore, 
Canada requests once again that India suspend the implementation of this measure and allow trade 
to continue without a certificate requirement. This would provide an opportunity for India to further 
engage with Members to discuss and consider an alternate, less trade -restrictive approach that 
would meet India's objectives and minimize disruptions to trade. Canadian officials would be pleased 
to contribute to these discussions and share its extensive experience in this area. In addition, 
conside ring that the Order's stated objective is "to ensure the safety and wholesomeness of articles 
of food imported into India", we are of the view that it should be notified to the WTO Sanitary and 
Phytosanitary (SPS) Committee. Lastly, Canada looks forward to  receiving detailed responses to its 
comments submitted through India's TBT Enquiry point in October 2020.  
4.400.   The representative of Uruguay  provided the following statement. Uruguay recognizes India's 
right to take measures to guarantee the safety of food and  the health of its population.  However, 
Uruguay wishes to recall that there is consensus internationally that genetically modified products, 
approved by exporting countries on the basis of Codex recommendations in relation to the risk 
assessment methodolog y, are equivalent to their conventional counterparts.  Therefore, in Uruguay's 
view, there would not appear to be any technical justification for the implementation 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.  Bearing in mind the 
above -mentioned objective, we would like to ask the delegation of India why it has not yet notified 
this measure to this Organization's Committ ee on Sanitary and Phytosanitary Measures.  Uruguay 
wishes to stress the importance of Members establishing measures based on scientific principles and 
particularly of applying such measures with the objective of minimizing the negative trade effects, 
in line with the provisions of the TBT and SPS Agreements.  We await any comments that the 
delegation of India may make in response to Members' concerns expressed in both Geneva and New 
Delhi, including in a joint note submitted by a number of countries – one of  which being Uruguay – 
in January this year, to which a reply has not yet been received.  
4.401.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and supports measures that focus on legitimate objectives, including the p rotection 
of human health and safety. New Zealand remains concerned that India's requirements regarding 
non-GM certification for specific foods is imposing further restrictions and costs on existing trade in 
goods covered by the measure. New Zealand encour ages India to accept a country -wide assurance 
as an alternative consignment -based non -GM certification. We would appreciate clarification on what 
consideration India has accorded to less trade -restrictive alternatives for those countries that have 
not appr oved the release of any genetically modified crops into the environment. New Zealand again 
 
90 G/TBT/M/83, paras. 2.384 -2.386.  G/TBT/M/84  
 
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  notes the measure is implemented under food safety legislation. If the protection of human health 
is the objective, in whole or in part, can India advise whether it intends to also notify the measures 
to the SPS Committee, given its relevance to provisions within the SPS Agreement, particularly 
Codex Alimentarius? We refer to New Zealand's more detailed written submission of 2 September 
2020 on India's notification G/TBT/N/IND/168  which outlin es its concerns that remain relevant 
today. We refer India to the comments New Zealand made on this measure at the most recent 
meeting of the SPS Committee. New Zealand strongly requests India adopt the least trade -restrictive 
alternative/s for those count ries that have not approved the release of any genetically  modified crops 
into the environment.  
4.402.   The representative of Argentina  provided the following statement. Argentina would like to 
once again express its concern regarding the new Order issued by the F ood Safety and Standards 
Authority of India (FSSAI), notified in document G/TBT/N/IND/168 , which requires imports of food 
products to have a certificate of Non -GM product origin.  We stress the importance of basing any 
measure of this type on scientific principles so that it does no t become an unnecessary barrier to 
international trade. Scientific evidence shows that duly authorized GM products are as safe as their 
conventional equivalents and there is no justification for discriminating between one or the other.  
We hope that India will amend the notified Order soon. We recall that we have already submitted 
more detailed comments and specific questions through the TBT Focal Point and hope that they will 
be reviewed by the Indian authorities in order to safeguard the normal flow  of trade in agri -food 
products.  
4.403.   In response, the representative of India provided the following statement. It may be noted 
that Genetic Engineering Approval Committee (GEAC) is empowered under the Rules for the 
Manufacture/Use/Import/Export and Storage of  Hazardous Microorganisms, Genetically Engineered 
Organisms or Cells, 1989 of the Environment Protection Act (EPA) 1986 for approval of proposals 
relating to release of genetically engineered organisms and products into the environment. The 
Committee has s o 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 crop s. Further, FSSAI has 
clarified the non -applicability of this requirement for import of processed food via letter dated 
12 October 2020.  
4.1.3.50   Russian Federation - Federal Law n° 468 on wine making and wine growing in 
the Russian Federation (ID 65091) 
4.404.   The repres entative of the United States  provided the following statement. The United States 
continues to request that Russia notify implementing measures to the WTO TBT Committee, provide 
at least 60 days for interested stakeholders to comment on the measure, and ta ke submitted 
comments into account before finalizing these measures. The United States also continues to seek 
a response to our comments on Federal Law n° 468 submitted to Russia's WTO TBT Enquiry Point in 
August 2020. Does Russia intend to respond to comm ents received from WTO Members? Of 
particular concern to the United States is Article 24 of the Law, which outlines prohibited 
technological methods for the production of wine. More specifically, sub -article 11 refers to the use 
of imported wines in the pr oduction of wine in Russia. Can Russia please confirm if foreign wines 
imported in bulk for bottling in Russia are permitted and, further, if these products can be labelled 
as wine produced in the foreign country and bottled in Russia? Lastly, we understan d that Russia is 
in the process of aligning Federal Law n° 468 with EAEU Technical Regulation 047/2018 on the safety 
of alcohol products. We also understand that the Eurasian Economic Commission requested that the 
Russian Federation draft and submit amendm ents to the Technical Regulation by 30 April 2021. Can 
Russia provide an update on the status of that process?  
4.405.   The representative of the European Union  provided the following statement. Russia has 
adopted a measure "Federal Law Nº 468 of 27 December 2019 o n 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, despite 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 importation of wine and wine -based products into the Russian Federation ter ritory. 
Regarding wine -based products: geographical indications and discrepancies between the Law and 
 
91 For previous statements follow the thread under ID 650 . G/TBT/M/84  
 
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  OIV provisions. The EU is very concerned that the Law will have a strong impact on import of foreign  
wines. In this context, the EU would like to ensure t hat enriching wine with concentrated grape must 
or rectified concentrated grape must or sucrose to attain a higher alcohol content level is an 
authorized (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.  
4.406.   The EU has been informed that Russia has sent letters to some EU member States requesting 
consultations and detailed information exceedi ng the normally exchanged information and mutual 
assistance between competent authorities in relation to the wine sector. The Commission has sent 
the reply on behalf of the member States and is ready to provide any relevant information in this 
respect. A p rocess of alignment of EAEU TR47 is currently on -going. The EU sent proposals of 
amendments aiming at improving the alignment to international standards. The EU hopes these will 
be considered and retained in order to facilitate international trade both way s. Lastly, it seems that 
the Federal Law also contains provisions covered by the Agreement on Trade -Related Aspects of 
Intellectual Property Rights. The EU would like to invite Russia to notify the measure to the Council  
for TRIPS. The EU invites Russia to  notify the new wine measure, 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.  
4.407.   The representative of Australia provided the following statement. Australia thanks the 
Russian government and industry for its recent engagements on this issue. 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. Australia notes the value of 
Australian wine exports to the Russian Federation has slightly increased since the implementation 
of the law. However, Australia still maintains concerns regarding several import barriers posed by 
the Federal law. As noted at previous TBT Committees, these include: The mandatory declaration of 
vintage and variety required under the new law does not reflect International Organisation of Vine 
and Wine (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 g iven 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.  
4.408.   In relation to the ageing process, Article 18 includes a category referred to as "brand " wine, 
which requires 18 months ageing following 1 January in the year following harvest. If this means 
wine cannot be given a brand unless it has been aged for 18 months , only Australian wine from 2018 
and earlier would be permitted to carry a brand in Russia. 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 additio n of water to dilute high sugar musts to aid fermentation. Minimal additions of 
water aids fermentation during periods of difficult seasonal conditions, including drought. 
Additionally, Australia notes several obligations within the Federal wine law are in consistent with the 
Eurasian Economic Union Technical Regulation 047/2018 "On safety of alcohol products ". Australia 
understands that the implementation of the technical regulation has been postponed to allow 
harmonization work with the Russian Law. Austra lia encourages Russia to take into account concerns 
raised by Members during the harmonization phase, including ensuring the technical regulation 
aligns with international production standards. We look forward to Russia notifying the WTO of these 
measures accordingly.  
4.409.   The representative of Argentina  provided the following statement. Argentina would like to 
once again highlight its concern regarding the implementation of the Law on wine making and wine 
growing in the Russian Federation (Federal Law No. 468 – FZ). We are particularly concerned about 
the unilateral alterations of the product name, which could result in misinformation regarding the 
product and consumer confusion. Under the new Law, "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 process or oenological procedure and is not blended with 
other beverages or substances.  Our country trusts that through constructive dial ogue with 
stakeholders, appropriate amendments can be made to the standard in order to avoid unnecessary 
obstacles to trade.  G/TBT/M/84  
 
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  4.410.   In response, the representative of the Russian Federation  provided the following statement. 
Russia took note of the statements made  by the delegations of the EU, the US, Australia and 
Argentina. Statements will be sent to relevant Russian authorities for consideration. We refer to our 
previous statements on this subject in the WTO working bodies. Today, in response we would like 
to highlight the following. The Federal Law on winemaking and winegrowing entered into force on 
the 26 June 2020. The Law is aimed to develop and improve Russian internal wine market; it sets 
requirements both for domestic and foreign winemakers irrespective of  their origin. The provisions 
of the Federal Law are elaborated taking into account the obligations of the Russian Federation in 
the WTO and other international organizations. Despite raised concerns about the Federal Law, 
statistics show that imports of w ine to the territory of the Russian Federation did not substantially 
decline. As for the TRIPS Agreement, we stress that this Law does not cover intellectual property 
rights and does not set the legal environment for protection of IPR. In the Russian Feder ation 
intellectual property rights are registered and protected under the Civil Code of Russia that is based 
inter alia  on Russia's obligations under the TRIPS Agreement.  
4.1.3.51   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 66292) 
4.411.   The representative of the United States  provided the following statement.  The United States 
recalls its February 2021 intervention and thanks Panama for recent bilateral discussions. 
Unfortunately, no progress has been made toward addressing our concerns.  We continue to receive 
reports of rejected or detained US onion shipments, and we are concerned about the impact on US 
potato exports when the potato regulation enters into force on 2 June 2021. Given the negative 
impact on US onions, the potential impact  on US potatoes, and Panama's lack of transparency, we 
again urge Panama to suspend implementation of both regulations indefinitely in order to address 
WTO Members' concerns. Panama has yet to explain its rationale or technical justification for these 
meas ures. As we have explained, Panama's harvest date requirement presents an unnecessary trade 
barrier, and we have not heard of any other country in the world imposing such a requirement. 
Onions and potatoes can be marketed for many months after harvest due to quality of the seed, 
variety selection, good supply chain practices, cold storage, and other technologies. We reiterate, 
again, that the relevant international standard in Codex specifically excludes vegetables from "use-
by date " or "best-before date " labelling requirements and clarifies that providing a "date of 
manufacture " or "date of packaging " is optional. Panama's zero sprouting requirement does not 
appear necessary or practical. The market differentiates between different qualit y grades of onions 
and potatoes. Entire shipments should not be rejected because a few sprouted onions were found.  
4.412.   The representative of Canada  provided the following statement. Canada would like to join 
the United States to signal its concerns with Panama 's new quality requirements for fresh potatoes 
established by the Ministry of Industry and Commerce on 20 February 2020. Canada is Panama's 
second largest supplier of fresh potatoes. It has recently come to our attention that the 
implementation of Panama's  new quality requirements could have a direct impact on Canadian 
exports to Panama. We therefore share some of the concerns raised by the United States in their 
intervention. Canada understands that Panama has twice delayed the implementation of these 
meas ures. However, in light of the potential trade implications these new requirements could have 
on Canadian exports, Canada respectfully supports the request of the United States that Panama 
delay its entry into force. This would provide sufficient time to e ngage bilaterally on this issue to 
discuss elements of concern and explore potential options to find a viable solution. Canada looks 
forward to further discussions with Panama on these new requirements.  
4.413.   The representative of the European Union  provided the  following statement. The EU joins 
the trade concern voiced  by the US and Canada. Our exporters are also facing similar difficulties in 
agro-food trade with Panama . The European Union would like to express the importance of speedy, 
consistent and transpare nt SPS procedures carried out by independent authorities and the need  to 
avoid unnecessary TBT barriers. The European Union is prepared to work bilaterally with Panama to 
find a s atisfactory solution . 
4.414.   In response, the representative of Panama  provided the following statement. The delegation 
of Panama takes note of the comments from the United States, Canada and the European Union, 
which I will forward to my Ministry.  The delegation of Panama has continued to hold bilateral capital -
to-capital meetings aimed at resolving this issue, and we will continue our efforts to find a mutually 
 
92 For prev ious statements follow the thread under ID 662 . G/TBT/M/84  
 
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  satisfactory solution. We will share with the Committee any information that we receive as a result 
of these conversations.  
4.1.3.52   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 65993) 
4.415.   The representative of Australia  provided the following statement. Australia thanks the EU for 
clarifying their labelling requirements at the previous TBT Committee meeting. Given that wine is 
regularly expo rted to the EU through the UK, and that Brexit has heavily impacted this arrangement, 
we reiterate our concerns raised at previous meetings. We look forward to working closely with the 
EU on this issue to ensure a mutually satisfactory outcome that is no m ore trade restrictive than 
necessary.  
4.416.   In response, the representative of the European Union  provided the following statement. As 
explained in previous TBT Committees, the indication of the "importer" is a compulsory indication 
for wine imported into the EU  and the importer is understood as 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 on ly acceptable 
as an optional particular, provided it does not appear in combination with the words "importer" or 
"imported by (…)" and provided it is not misleading for consumers as regards the business food 
operator (i.e. the person assuming responsibilit y for bringing the wine into circulation in the EU).  
4.1.3.53   European Union - Waste Framework Directive, G/TBT/N/EU/778  (ID 65894) 
4.417.   The representative of India provided the following statement. The Republic of India has been 
raising this STC in the last two TBT meetings. The EU has given a re sponse in the last TBT meeting 
held in February 2021. We thank the EU for the detailed reply; however, the concerns raised by 
India are still not addressed. Hence, we reiterate the statement made in the February 2021 TBT 
meeting and request the EU to respo nd to the issues of concern not addressed so far and which are 
listed here. The Non -EU companies have no provision of an Only Representative (for its compliance), 
thus they have to share the product details with the buyers; there is an issue of sharing int ellectual 
property/Know -how sharing, which will act as a barrier to trade implicitly. The non -EU companies  
are treated unfairly. They have to depend on the EU buyers as they will have no choice to do the 
activities by themselves. EU buyers may require unnecessary testing and declarations in situations 
where it may clearly be a non -SVHC product/article. EU -buyers may insist on certain specific testing 
facilities to be used and would have undue cost implications on the non -EU suppliers. Since major 
industries are impacted because of the COVID -19 pandemic, the deadline must be extended for the 
industry to comply w ith these new requirements/special provisions for compliance  
4.418.   The representative of China  provided the following statement. We suggest that the EU 
provide a sufficient comment time and transition period in accordance with WTO/TBT Agreement. In 
view of the i nformation security issues that concern all parties, it is suggested that the EU provide 
relevant documents and hold seminars to explain how data security is protected in this field.  
4.419.   In response, the representative of the European Union  provided the follow ing statement. 
The European Union (EU) would like to thank India and China 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 Europ ean Union would like to recall that extensive 
information was provided to Members in the past two Committees and would like to reply to the 
specific further questions by India. First, the European Union would like to reiterate that only legal 
entities esta blished in the EU can make SCIP notifications. The Waste Framework Directive contains 
no provisions for an "only representative " for non -EU companies, as it happens under REACH for the 
purpose of registration. However, in order to support non -EU companies to fulfill their obligations, 
European Chemicals Agency (ECHA) has developed a "foreign user " functionality in its submission 
tool. An EU importer may set up contractual agreements with their non -EU suppliers of articles to 
act on their behalf (as a "forei gn user"), regarding the submission of data to the SCIP database. 
However, the responsibility of the SCIP notification and its content still lies with the EU importer of 
articles originating from third countries. Under the Waste Framework Directive, simila rly as under 
 
93 For previous statements follow the thread under ID 659 . 
94 For previous statements follow the thread under ID 658 . G/TBT/M/84  
 
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  REACH, the EU can only hold accountable those legal entities that operate in its territory. For further 
information see Q&A no 1665 published on the website of the ECHA.  
4.420.   Second, as regards confidential business information, only the data that is strictly necessary 
to ensure safe use of articles by consumers and waste operators is requested and will be made 
publicly available. Guidance is available on the ECHA website explaining what information is needed 
and how to prepare SCIP notifications. I t should therefore be possible to prepare a SCIP notification 
without revealing confidential business information or the know -how of the product. Third, neither 
Article 9 of the Waste Framework Directive, which defines notification obligations to ECHA, nor  
Article  33 of REACH, specify the need for testing or specific requirements such as the use of specific 
test facilities. It is up to importers of articles into the EU to obtain the necessary information from 
non-EU suppliers, including justification regard ing the absence of SVHCs in the product/article. 
Finally, both the obligation to notify and its date of application have been laid down by the co -
legislators in the revised Waste Framework Directive, and the Commission is not empowered to 
modify them. Furt hermore, the deadline has already past, the obligation applies from 5 January 
2021 and ECHA had, by end of April, received over 12 million submissions to the database. The 
European Union expects that, to a certain extent, suppliers can build on arrangement s put in place 
to comply with the existing obligation under Article 33 of the REACH Regulation to provide 
information on the presence of substances of very high concern in articles. The European Union 
would like to refer to the statement from the past TBT Committees for more information and remains 
available to provide replies with regard to the SCIP database to interested Members.  
4.1.3.54   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/TBT/N/FRA/199,  G/TBT/N/FRA/200,  G/TBT/N/FRA/201,  
G/TBT/N/FRA/202,  G/TBT/N/FRA/203  (ID 65795) 
4.421.   The representative of China  provided the following statement. China appreci ates France's 
efforts to fight against waste and boost the circular economy and fulfill the transparency obligation 
under WTO, and give replies to our comments. But from the perspective of no creating unnecessary 
trade barriers, in accordance with the requ irements specified in Article 2.12 of the TBT Agreement, 
we raise following comments once more. It is suggested to delay the implementation of penalty 
clauses related to violation of the repairability index information in Environmental Law L.541 -9-4. 
At present, in addition to washing machines, smart phones, laptops, televisions, and electric lawn 
mowers (batteries, cables, and robots), France has not yet released the specific evaluation 
requirements for the repairability index of other electronic and elect rical products, and has not 
published any related implementation plans. Even if France immediately releases the requirements 
for the repairability index except the above products, excluding the time for all other parties to 
review, the transition period fo r each manufacturer is only half a year, which would make troubles 
to enterprises that have been devoted to compliance of their productions and sales. Therefore, it is 
obviously not reasonable to impose penalties since 1 January 2022 for violations of the obligation of 
information reporting. We propose to delay the entry into force of Environmental Law L.541 -9-4. It 
is suggested to amend Article L541 -9-2 of the Environmental Law. The new decree would apply to 
products placed on the market after the decree c oming into force, rather than products on sale. The 
reasons are as follows.  
4.422.   If a large number of products that have been placed on the market are to be rectified for 
compliance, it will take a lot of time and cost; some products may be delisted, so it is n ot reasonable 
and does not conform with the concept of green environmental protection. In addition, Article L411 -
1 of the French "Consumer Code " states that "From the first time they are placed on the market, 
products and services must meet the requirement s in force relating to the safety and health of 
persons, the fairness of commercial transactions and consumer protection. The person responsible 
for placing a product or service on the market for the first time verifies that it complies with the 
regulation s in force. " "Placed on the market " is used as a control switch. Therefore, it is 
recommended that Article L541 -9-2 of the Environmental Law could not apply to the products that 
are already sold on the market.  
4.423.   It is suggested to clarify the relevant law en forcement entities and law enforcement 
responsibilities, as well as the customs clearance and market supervision of products in France 
before the penalty clause enters into force on 1 January 2022. The reasons are as follows. At present, 
 
95 For previous statements follow the thread under ID 657 . G/TBT/M/84  
 
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  the regulations re lated to the repairability index have taken into effect, and the related penalties will 
be implemented in the future. However, the law enforcement body is not clear, during the period 
from 2021 to 2022, the following issues will cause difficulties for econ omic operators (including 
manufactures). Will the French customs inspect and prohibit then on -compliant products? Will  
relevant agencies in the French market put forward compliance requirements for related products 
according to law? Therefore, it is recomm ended to clarify the relevant law enforcement entities and 
law enforcement responsibilities, and explain the above issues. It is suggested that France releases 
the applicable product catalogue scope in Article L541 -9-2 of the Environmental Law, provide the  
specific applicable time schedule of the product laws and regulations, and specify an example 
template for each type of applicable product for repairability index assessment, so as to facilitate 
compliance rectification for the enterprise.  
4.424.   In response, th e representative of the European Union  provided the following statement. For 
the time being, even though the general regulation (Décret no 2020 -1757 du 29 décembre 2020) 
includes all electric and electronic products in its scope, the requirements only conc ern the product 
categories for which a technical regulation ( "arrêté ") has been adopted: front -loading washing 
machines, smartphones, laptops, TV monitors, and electric lawn mowers (three types: with electric 
cable, with battery, robot). The requirements apply only to products put on the market from the 
date of entry into force of the regulation, i.e. 1 January 2021. The official regulatory texts (décret 
and arrêtés) can be found below.96 The market surveillance authorities will carry out rand om controls 
as of 1 January 2022. The controls will focus on the effective presence of the repairability index on 
the products and on the veracity of the information provided as part of the repairability index. There 
are currently no requirements for other  product categories. A reflection is ongoing about an 
extension of the requirements to other product categories. However, no decision has been taken 
yet. In any case, if such an extension takes place, France will notify the new implementation 
measures to t he WTO, and there will be a transition period to allow economic actors to get ready for 
the implementation. Several technical documents (instructions manual, calculation grid, graphic 
charter) are available in French and English in order to help manufactur ers and retailers to comply 
with the regulation. They can be found below.97 
4.1.3.55   Chile - Technical specifications for the design of energy efficiency labels for 
washing machines, G/TBT/N/CHL/297,  G/TBT/N/CHL/325  (ID 65498) 
4.425.   The representative of the Republic of Korea  provided the following statement. Korea resp ects 
the efforts of Chile to protect the environment, and Korean companies are fully committed to 
complying with the regulations of Chile. Korea wants to express our gratitude to Chile for responding 
to Korea at the February 2021 TBT Committee Meeting. Chi le said that it was currently reviewing a 
new regulation regarding the energy efficiency label for washing machines and would try to reflect 
stakeholders' opinions, including those of Korea. Korea would like to be informed of the revision's 
current status and whether or not Korea's opinions have been reflected in the revised standards. In 
addition, Korea requests that Chile notify the WTO before the implementation date and provide 
sufficient time for Korean companies to prepare for the new regulation.  
4.426.   In response, the representative of Chile provided the following statement. As Chile has 
previously reported, the recent focus has been on implementing Law No. 21.305 on energy 
efficiency, which was published in February and should result in a number of sectoral  regulations 
entering into force by next February.  The Chilean Ministry of Energy has prioritized its work on the 
above -mentioned regulations, and would like to inform the Korean delegation that it has not yet 
been possible to begin amending the energy eff iciency protocol for washing machines. When it does 
become possible to make these amendments, a transparent national and international public 
consultation process shall be conducted and will be reported to this Committee.  
4.1.3.56   Republic of Korea - Revision of Safety Conformation Criteria for Textile Products 
for Infants, G/TBT/N/KOR/678  (ID 65299) 
4.427.   The representative of the European Union  provided the following statement. The EU would 
again like to raise its concerns with regard to the Republic of Korea's requirements for conformity 
 
96 https://www.ecologie.gouv.fr/indice -reparabilite   
97 https://www.ecologie.gouv.fr/indice -reparabilite   
98 For previous statements follow the thread under ID 654 . 
99 For previous statements follow the thread under ID 652 . G/TBT/M/84  
 
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  testing of textile products for infants. The EU pays the utmost attention to and underlines the 
importance of product safety in its market, including that of product safety for infant clothing. Any 
item of baby wear for sale in the EU must comply with the EU's General Product Safety Directive 
(2001/95/EC). Additionally, there are several European standards that apply specifically to children's 
clothing. In particular, the harmonized standard 14682 contains requirements to ensure that cords 
and drawstrings are placed safely on apparel for babies and children up to 14 years. This is to avoid 
strangulation and choking hazards. Furthermore, any item of baby wear on the EU market must 
comply with the REACH Regulation (registration, eva luation, authorization and restriction of 
chemicals). Several chemicals commonly used in apparel production are restricted under REACH. 
The EU believes that the extra testing required by Korea is more trade -restrictive than necessary to 
fulfill a legitimat e objective. 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 laboratory that  carries out tests according 
to specific standards.  
4.428.   Due to this measure, a huge amount of clothing samples have to be sent to Korea for testing, 
resulting in a substantial increase of testing and certification costs for European producers. As an 
example, t he total testing costs for infant clothing of an EU producer increased by 30% in 2018 
compared to 2017 and by 1154% in 2019 compared to 2017. The corresponding sales figures were 
a decrease of 13% and 19%, respectively. Hence, these costs are independent o f sales and not one -
off in nature. In an effort to facilitate the customs procedures, EU companies applied to the Korea 
Customs Service (KCS) to be recognized as a "best practice company" last year. However, according 
to the reply from KCS, this applicatio n requires Korean Agency for Technology and Standards (KATS) 
to provide KCS with information about the post management plans for the companies and this 
information was not completed by the deadline hence the consultation between KATS and KCS was 
not conclu ded, and ultimately, KCS could not approve the companies as best practice companies. 
Could Korea please provide some assistance as regards the procedures between KCS and KATS in 
applications for "best practice company" status? The EU kindly requests that t he Korean authorities 
take the necessary steps to remove this trade barrier. In order to alleviate the issue, the EU requests 
that Korea allow the required conformity testing to be performed outside of the country by an 
internationally accredited laborator y according to the Korean product standard.  
4.429.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea appreciates the interest of EU in Korea's regulation for Textile Products for infants. Korea and 
EU have been havin g several meetings to resolve these concerns since early last year, including the 
meeting last April right before this TBT Committee meeting. The EU has raised concerns regarding 
specific textile products used by or for infants under 36 months of age. Spec ifically, 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, esp ecially 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 addition, 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 legitimate obje ctive of protecting human health or safety. 
Regarding the EU's concerns about a substantial increase in testing and certification costs for 
European manufacturers due to the amended requirements for Textile Products for Infants, we found 
that during the re levant 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. As for the relationship between the increase of testing a nd certification costs 
and the decrease of sales figures, we have not found any basis for this claim nor any direct 
connection between them during the relevant period. Regarding customs procedure, the role of the 
Korea Customs Service is prescribed by the Customs Act. Regarding the topics which are not included 
in our response, Korea thinks those topics are related to a few specific stakeholders so they could 
be more effectively handled outside of the WTO TBT meeting. Korea sincerely hopes to resolve the 
EU's concerns in a mutually beneficial manner in the near future.  G/TBT/M/84  
 
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  4.1.3.57   India - Testing and Certification of telegraph (The Indian telegraph 
(Amendment) Rules, 2017) and Phase II of the Mandatory Testing and Certification of 
Telecommunications Equipment (MTCTE), i mplementing the Indian Telegraph 
Amendment, G/TBT/N/IND/66,  G/TBT/N/IND/159,  G/TBT/N/IND/160,  
G/TBT/ N/IND/158  (ID 646100) 
4.430.   The representative of China  provided the following statement. We suggest that India provide 
a sufficient comment period and transition period in accordance with WTO/TBT Agreement and 
accept test results from laboratories accredited by International Laboratory Accreditation 
Cooperation (ILAC) signatories, and speed up product application approval.  
4.431.   The representative of the United States  provided the following statement. The United States 
remains concerned that India is no longer acceptin g test results from foreign laboratories accredited 
by International Laboratory Accreditation Cooperation (ILAC) signatories as proof of conformity to 
India's Mandatory Testing and Certification of Telecom Equipment (MTCTE) procedures. We would 
be interest ed in India 's views on why it does not recognize such test results, particularly since India 
is an ILAC member.  Considering the scope of the test requirements under the MTCTE, the technical 
complexity involved, as well as disruptions to product testing an d certification caused by the COVID -
19 pandemic, the United States reiterates its request that India recognize all relevant test results, 
including electromagnetic interference and electromagnetic compatibility (EMI/EMC) results, from 
ILAC-accredited labor atories, for at least one year from the date of publication of any future MTCTE 
phases. 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 non -certified 
products, including new models.  We understand that Phase III of the MTCTE could be implemented 
by the end of 2021. Can India provide any information on Phase III, including potential timelines for 
implementation?  
4.432.   The representativ e of Canada  provided the following statement. As Canada noted in previous 
meetings of the Committee, we appreciate the extension, to 30 June 2021, of the 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). 
Canada hopes that this extension will be prolonged beyond 30 June and, recognizing the challenge 
posed by the COVID pandemic, that firms will be n otified as early as possible. Can India provide us 
with information on this possibility? We continue to note the high cost that the measure imposes on 
foreign suppliers, which must produce the product for testing, ship it to India and then wait for the 
product to be tested before being able to put it on the market. We also wish to reiterate our concern 
with India's movement away from accepting testing in ILAC accredited labs, outside India, for 
telecommunications equipment. Accepting foreign test results, i n appropriately accredited labs, is 
the least trade -restrictive manner of achieving legitimate safety and security objectives.  
4.433.   In response, the representative of India provided the following statement. Acceptance of 
test results from laboratories accredite d 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 (Amendment) Rules, 2017, is 
reviewed from time to time. As adequate in -country testing capability now exists for EMI/EMC and 
safety -related test parameters, relaxation for acceptance of test results from laboratories accredited 
by International Laboratory Accreditation Cooperation (I LAC) 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 r elaxation for products to be covered under future phases of MTCTE, 
they will be looked into at the time of the launch of notification for such products. Moreover, the 
MRA agreement with India shall facilitate OEMs to test in MRA partner country, which may lessen 
the burden in terms of cost and time. 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 from six to eight m onths 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 c omply with the labelling requirement of MTCTE for such products. The request to provide 
firms with at least one year to comply with any future phases of the MTCTE shall be considered at 
 
100 For previous stateme nts follow the thread under ID 646 . G/TBT/M/84  
 
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  the time of launch of future phases of MTCTE. Phase -III of MTCTE is un der consideration, and 
timelines for implementation will be intimated when the proposal is finalized.  
4.1.3.58   European Union - Testing methods for prohibited chemicals of regulation on 
cosmetic products, G/TBT/N/EU/752  (ID 680101) 
4.434.   The representative of China  provided the following statement. We suggest that the EU 
clarifies the testing methods for volatile nitrosamines contained in nail polish products.  
4.435.   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, which was elaborated in our statement for 
the TBT Committee in February 2021. The EU would like to refer China to this previous statement 
as well as to the w ritten reply of 4 February 2021.  
4.1.3.59   Nigeria - Onerous testing and conformity requirements by societe generale de 
surveillance, (SGS) for machinery and their parts (ID 679102) 
4.436.   The representative of India provided the following statement. The delegation of India  raised 
this concern in the February 2021 TBT meeting. The Republic of India is deeply concerned about 
Nigeria's onerous certification and conformity requirements, which adversely affect the Indian 
exports to Nigeria. Under the current system, all Nigerian  importers must obtain a Product Certificate 
and a SONCAP Certificate (SONCAP is a pre -shipment verification of conformity to Nigerian 
standards) for each consignment. The process of obtaining a Product Certificate and meeting the 
conformity assessment req uirement is onerous, intensive, and expensive. It involves an elaborate 
two-step process, briefly explained below. First step: Obtaining Product Certificate: to place an order 
for importing to Nigeria, the importer needs a Bank in Nigeria to issue Form M. This Form M can only 
be issued based on product certificate. The product certificate is given 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 intent for payment. From this, it is clear that obtaining 
a product certificate is a circulatory and highly trade -restrictive process. Secondly, the validity of a 
product certificate issued by Nigerian authorities is only six months, which is a  very short time. This 
adds an extra burden on the exporter in terms of the cost and time required to obtain another 
product certificate.  
4.437.   Second step: Obtaining SONCAP Certificate: Once the order for a product is placed and the 
product certificate requirem ent is met (as mentioned in the first step), but before the product is 
exported to Nigeria, a SONCAP Certificate for each consignment is required. This requirement of 
obtaining a SONCAP certificate is in addition to the product certificate requirement. Thi s process of 
conformity assessment for each shipment is cost -intensive and involves onerous procedures. 
Countries establish such onerous conformity assessment requirements for products that have 
implications for human health, plant/animal health or environ ment, or products of prohibited 
category or originating from restricted countries. In other words, the degree of risk associated with 
importation is determined for placing such stringent conformity assessment requirements. However, 
in Nigeria's case, excep t for few products, each consignment is required to carry a SONCAP 
certificate. The requirement of a SONCAP certificate for each consignment appears to be violative of 
Article 5.2 of the TBT Agreement, requiring that a WTO Member's conformity assessment pr ocedures 
do not create unnecessary obstacles to international trade. Additionally, Article 2.2 of the TBT 
Agreement specifies that Members must not prepare, adopt or implement any provisions that would 
create unnecessary international trade barriers. Also,  it must not be more trade restrictive than 
necessary to fulfill a legitimate objective. We consider these measures to be highly trade restrictive 
and create unnecessary obstacles to trade. Hence, Nigeria is requested to consider simplifying the 
procedure for obtaining the product certificate. Nigeria is also requested to share the risk assessment 
study done to arrive at the following decision: a) requirement of a product certificate for all products; 
b) six months validity of product certificate;  c) the r equirement of obtaining a SONCAP certificate 
for each consignment; and d) the less trade -restrictive measures that were considered before 
finalizing the present mechanism.  
 
101 For previous statements follow the thread under ID 680 . 
102 For previous statements follow the thread under ID 679 . G/TBT/M/84  
 
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  4.438.   In response, the representative of Nigeria  provided the following statement. Nigeria  wishes 
to thank India for its interest in this issue. Nigeria notes that some of the issues raised by India are 
inaccurate and wishes to state that the measures and its applications are in accordance with the 
provisions of the WTO Agreement and Internatio nal Best Practices. Regarding the issue of Product 
Certificate, these certificates are issued on behalf of Nigeria by mandated International Accredited 
Firms pursuant to the provisions of the Agreement on Pre -shipment Inspection. These firms are also 
guide d by the PSI Code of Practice of the Testing, Inspection and Certification Council (TIC Council). 
On India concern regarding Nigeria requirement of a product certificate for all products, it is pertinent 
to note that the certificate is an attestation that Pre-Shipment verification has been undertaken 
based on: (i) the WTO Agreement on Pre -shipment Inspection and subsequent recommendations 
thereof and (ii) the WTO Agreement on Customs Valuation. Being a certificate, it is necessary for 
each and every consign ment to meet this requirement. However, contrary to India's claims that 
Products Certificates are required for all products, Nigeria wishes to state that Food and Medicines 
are exempted from this requirement. Also, chemicals used as raw material by bonafid e 
manufacturers and industrial machineries are exempted. Other products exempted include military 
wares and equipment and used automobiles of models over ten years.  
4.439.   On the issue of validity of Product Certificate, India's contention regarding six -months 
validity of Product Certificate is inaccurate. Under the existing guidelines, there exist three routes 
for Product Certification depending on the product type, risk and effects on health, environment, 
national security, and consumer trust. Route A – Product Certificates are for unregistered category. 
These are for products purchased one -off or off the shelf. These products are of high risk thus the 
need for inspection, product sampling and testing. The Product Certificate which is for single use is 
valid for six months. Regarding Routes B and C – Importers under these routes are covered by 
Products Certificate with one -year validity and multiple use. The difference between B and C is that 
C is open to manufacturers for brand protection. These routes also facto r in various risks associated 
with products. Regarding India's concern on the requirement of obtaining a SONCAP certificate for 
each consignment, Nigeria wishes to state that prior to the adoption of the Pre -Verification of 
Conformity (PVoC) to Standards, named "Standards organization of Nigeria Conformity Assessment 
Programme (SONCAP)", notification containing detailed procedure for the programme was duly 
issued to WTO and thereafter circulated amongst Members including India for review and comments. 
The c omments by Members which centred around the need for the provisions of paragraph 4 of 
Article III of GATT 1994 and Paragraph 5.1.1 of Article 5 of the TBT Agreement to be respected was 
taken into account by Nigeria. This birthed the Mandatory Conformity As sessment Programme 
(MANCAP) scheme for locally manufactured goods. The SONCAP certificate as an end process 
document meant to attest that all other requirements of inspection and testing as provided by the 
relevant standards for the products have been carr ied out. Being a certificate, it is necessary for 
each and every consignment to meet the requirement. However, contrary to India's claims that 
SONCAP Certificates are required for all products, Nigeria wishes to state that some products 
exempted from Produ ct Certificate requirement which are mentioned earlier, are also exempted from 
SONCAP Certificate requirements.  
4.440.   Regarding India question on the less trade -restrictive measures that were considered before 
finalizing the present mechanism, Nigeria wishes to state that the requirements for Product and 
SONCAP certification are least trade restrictive. The requirement for Product Certificate is to enable 
Nigeria to achieve the legitimate objectives set out in the 3rd sentence of Article 2.2. This is because 
the need to take measures to curb the high prevalence of counterfeit and sub -standard imported 
products in Nigeria market cannot be overemphasized. These imported counterfeit and sub -standard 
products have negative effects on health, environment, national secu rity, consumer trust as well as 
the performance of genuine products in the markets. Also, Nigeria requirement for SONCAP is 
consistent with its obligation under paragraph 5.1 and 5.2 of the TBT Agreement. Non -fulfillment of 
the objectives of the Product an d SONCAP certification requirements, poses serious hazard to the 
lives and livelihood of Nigerians. The requirements for Product and SONCAP certification are not 
onerous, intensive, expensive, or trade restrictive. Rather, these requirements are Trade Faci litating 
and less trade restrictive. The alternative measures that were considered prior to the adoption of 
this measures include: (i) Destination Inspection. This scheme is more trade restrictive and likely to 
pose numerous difficulties including massive port congestion, unnecessary increase in time and cost 
of business; (ii) Flat single use product certificate with six months validity for all imported 
consignments regardless of the risk given the high prevalence of counterfeit and sub -standard 
imported pr oducts in Nigeria market; and (iii) the possibility of SON undertaking Pre -Shipment 
verification on behalf of Nigeria. This would have posed difficulties given Nigeria's small technical 
staff with high attrition rate. In conclusion, India may wish to note that the preamble of the TBT G/TBT/M/84  
 
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  Agreement clearly states that a Member shall not be prevented from pursuing a legitimate objective 
at the level it considers appropriate. Furthermore, Nigeria as a developing country is also a 
beneficiary of the flexibilities o f Article 12.4 of the TBT Agreement.  
4.1.3.60   United States - Energy Conservation Program: Energy conservation standards 
for residential dishwashers, G/TBT/N/USA/945/Add.3,  G/TBT/N/USA/1505/Add.2  (ID 
670103) 
4.441.   The representative of China  provided the following statement. We suggest that: (i)  At 
present, upon application, the United States grants exemption for sink -type dishwashers, but the 
exemption period has not been specified, which will inevitably bring unnecessary obstacles to trade. 
We recommend that the US clarifies the exemption perio d for sink -type dishwashers. (ii) Given that 
most types of dishwashers currently include a quick wash function of less than one hour, we 
recommend that the US clarifies the differences between dishwasher products with a washing 
process of less than one hou r and those currently with quick cleaning function of less than one hour, 
and classification basis for the two dishwashers.  
4.442.   In response, the representative of the United States  provided the following statement. The 
United States thanks China for its commen ts 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 an d consumer groups commented that the "quick or short cycle" that is present on 
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 des igned 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 dishwashers 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 Februa ry 2021, DOE published in the Federal Register a petition for waiver and granted 
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 dishwashes.  
4.1.3.61   United States - Appliance Efficiency for Sprinkler Bodies, G/TBT/N/USA/1489  
(ID 653104) 
4.443.   The representative of China  provided the following statement. We appreciate the efforts from 
the US to improve the performance of sprinkler bodies, and we suggest that (i) the US clarifies the 
application scope of sprinkler products.  (ii) as the accuracy r equirements of the pressure level test 
points in 1(c), 3(b) and 3(f) of Appendix B of WaterSense (r) Specification for Spray Sprinkler Bodies 
are inconsistent with the accuracy requirements of the international standard ISO15886 -3:2012 5.1. 
It is suggested  that the US could provide the basis for the accuracy requirements.  (iii) Please clarify 
the distance between the needle valve and the outlet pressure sensor in Appendix B, 3(c) which is 
not clear.  
4.444.   In response, the representative of the United States  provided the following statement. China 
did not submit comment to the United States through the USA WTO TBT Enquiry Point nor did it 
provide us any points in advance of this meeting. We have sought information from California, but 
it is taking some time. We wil l take the concerns back with us and engage the State of California, 
accordingly. Any information received will be communicated bilaterally with China.  
 
103 For previous statements follow the thread under ID 670 . 
104 For previous statements follow the thread under ID 653 . G/TBT/M/84  
 
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  4.1.3.62   India - Toys (Quality Control) Order, 2019, G/TBT/N/IND/131  (ID 587105) 
4.445.   The representative of the United States  provided the follow ing statement. The United States 
has repeatedly raised concerns with India's treatment of imported toys since 2017. With each new 
requirement, India has made it more difficult for exporters to successfully bring safe toys to market. 
As we noted at the last  meeting, India's 1 January 2021 implementation of the Toys Quality Control 
Order 2020 (QCO) has made it impossible for international toy companies to comply with the order 
given the continued inability of the Bureau of Indian Standards (BIS) to conduct in -person audits of 
foreign manufacturing facilities during the COVID -19 pandemic. US industry continues to report that, 
although BIS authorities are currently auditing domestic manufacturing facilities, they have yet to 
start audits of overseas manufacturin g plants, despite firms having submitted applications soon after 
the August 2020 BIS release of the QCO Product Manual. To date, companies with manufacturing 
facilities outside of India report that India has not provided any information about scheduling au dits 
by BIS inspectors and are unclear when BIS inspectors will resume traveling for such audits. 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 audi ts to complete the QCO requirements. 
According to industry, due to auditing delays, foreign manufacturers are unlikely to bring new toys 
to the Indian market in 2021. We support the Indian government's objective to ensure the quality 
of toys on the market,  and US industry has sought to provide alternative solutions to help India 
achieve those objectives while still facilitating trade in toys. Such alternative solutions include virtual 
audits or the use of recognized third -party certification of companies in  the country of manufacturing 
to meet the QCO's in -person audit requirements for foreign manufacturing facilities. Will India 
consider these alternative solutions in lieu of in -person audits by BIS inspectors?  
4.446.   In response, the representative of India provided the following statement. Foreign inspection 
visits are on hold due to the prevalent restrictions on international travel imposed by the Government 
of India, but in some instances by the government of other respective countries as well in view of 
the on going COVID -19 Pandemic. As soon as the situation of COVID -19 improves and the restriction 
lifted, India will plan the inspections (factory visit). The average time taken to grant a licence is 
generally four to six months after scheduled factory audits. Th is may vary for reasons like delay in 
response to queries raised, if any; organizing inspection(s); deposition of samples with lab and 
remittance of dues, etc. This does not account for delays related to COVID -19. As per Toys (Quality 
Control) Order, 2020 issued by the Department of Promotion for Industry and Internal Trade (DPIIT), 
Ministry of Commerce and Industry, every toy specified therein shall bear the standard mark under 
a licence from BIS as per Scheme -I of BIS (Conformity Assessment) Regulations, 2018. There is no 
provision in BIS (Conformity Assessment) Regulations, 2018, to undertake virtual inspection or the 
use of recognized third -party certification of companies in the country of manufacturing to meet the 
QCO's in -person audit requirements for  foreign manufacturing facilities. However, the Government 
of India is considering the introduction of relevant enabling provisions to undertake virtual/remote 
inspection for BIS conformity assessment activities.  
4.1.3.63   United Kingdom - Wine labelling and documen tation requirements at the end of 
the Brexit transition period (ID 663106) 
4.447.   The representative of Australia  provided the following statement. Australia thanks the UK 
for the response they provided in the previous TBT Committee and for the arrangement to allo w for 
either a European Union or a United Kingdom importer's details to be shown on the label of wine 
products marketed in Great Britain until 1 October 2022. We reiterate the concerns we have raised 
in previous meetings, noting that the United Kingdom con tinues to work with industry to develop 
streamlined labelling and documentation requirements. Australia seeks the United Kingdom's 
assurance that these requirements will not be unnecessarily trade restrictive. Australia appreciates 
the bilateral engagement  to date on this issue and looks forward to working closely with the UK on 
this issue to ensure a mutually satisfactory outcome.  
4.448.   The representative of Uruguay  provided the following statement. We wish to refer to our 
previous statements on this matter and once again express our interest in remaining informed of 
the regulatory requirements and conditions that will apply to the importation of wine into the United 
 
105 For previous statements follow the thread under ID 587 . 
106 For previous statements follow the thread under ID 663 . G/TBT/M/84  
 
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  Kingdom market from 1 October 2022, in particular with respect to documentation and labelling, 
and in such requirements being the least trade -restrictive possible.  
4.449.   In response, the representative of the United Kingdom  provided the following statement. 
The United Kingdom would like to thank Australia for its interest in our wine labelling and 
documenta tion requirements following the end of the United Kingdom -European Union transition 
period.107 We would also like to thank Australia for the constructive engagement we have had on 
this topic bilaterally. Referring to our previous statements for greater deta il, our regulations108 allow 
for either a European Union or a United Kingdom importer's details on the label of wine products 
marketed in Great Britain until 1 October 2022. After that date, only wine products bearing a United 
Kingdom importer's details can  be marketed in Great Britain. Additional details may be included on 
the label if they do not appear in combination with the words "imported by" or "importer", and do 
not confuse consumers as to the identity of the importer. The United Kingdom will continu e to accept 
wine import certificates (VI -1109) issued by the European Union for wine entering the United Kingdom 
from non -European Union countries.110 Further details of the labelling and certification measures 
that apply are available on the UK Government w ebsite.111 We appreciate Australia's recognition of 
our collaboration with industry to develop a streamlined and user -friendly system for labelling and 
documentation requirements. We welcome further bilateral engagement with Australia on this 
matter.  
4.1.3.64   Kingdo m of Saudi Arabia - Concerns on conformity assessment practices of Saudi 
Arabia against Turkish products (ID 683112) 
4.450.   The representative of Turkey  provided the following statement. Turkey would like to reiterate 
its serious concerns raised in the previous me eting as regards the discriminatory and unnecessarily 
burdensome product safety inspections conducted against Turkish products at Saudi customs. We 
witness that unjustifiably discriminatory treatment of Saudi Arabia against Turkish products with 
regard to conformity assessment procedures has been continuing in an ever -increasing manner 
leading to serious delays, high costs and bottlenecks for Turkish exporters. To put it more concretely, 
border compliance for Turkish -origin goods at Saudi Customs is complet ed in five months on 
average. In fact, we have been witnessing some cases where this period reached 300 days. In one 
specific case, we were informed that the customs clearance of the products of a Turkish white goods 
manufacturer took almost six months. It  was reported that 42 containers covered in 20 bills of lading 
had been held at customs ranging between 137 to 186 days. In fact, these goods were held at the 
customs for 109 to 160 days even after the approval they received from the relevant Saudi agencie s 
that the products met all the requirements mentioned in the relevant technical regulation and 
successfully passed the conformity assessment carried out at customs. This stands in direct 
contradiction with the principle justification given by Saudi Arabia n authorities for such long delays, 
that is, the testing and inspections conducted to check out the compliance of the products with the 
relevant technical regulation, and the customs tariff classification declared.  
4.451.   Turkey cannot make sense of such long del ays which contradict with the existing customs 
practices of Saudi Arabia explained in 2020 Doing Business Report. This report states that "time to 
import: border compliance " in Saudi Arabia takes 72 hours, which is equal to three days. Moreover, 
the Secret ariat Report of the Saudi Arabian Trade Policy Review states that a risk -based conformity 
assessment scheme is carried out for product safety inspections, and a simplified procedure is 
 
107 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 2020. 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 t o wine documentation and labelling. Some 
minor amendments have been, and are being, made to those retained Regulations to make them operable 
within our national context.  
108  See the Common Organisation of the Markets in Agricultural Products (Miscellaneous Amendments) 
(EU Exit) (No. 2) Regulations, SI 2020/1453. For further guidance, see 
https://www.gov.uk/guidance/importing -and-exporting -wine 
109 VI-1 arrangements are contained in the retained Regulation 2018/273 as amended by the 
Agricultural Products, Food and Drink (Amendment etc.) (EU Exit) Regulations 2020, SI 2020/163.  
110 See The Common Organisation of the Markets in Agricultural Products and  Common Agricultural 
Policy (Miscellaneous Amendments) (EU Exit) Regulations 2019 (2019 No. 828).  
111 https://www.gov.uk/guidance/importing -and-exporting -wine  
112 For previous statements  follow the thread under ID 683 . G/TBT/M/84  
 
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  conducted to facilitate product transits in case of a necessity for ins pection. Turkey's experience 
stands in direct contrast with this information. There are also cases where Turkish products are 
inspected in accordance with the conformity assessment procedures applied for a different product 
or rejected at customs due to pr oblems related to labelling, despite bearing the exact same labelling 
as before. Given ongoing restrictive practices of Saudi Arabia against Turkish products, including 
burdensome product safety inspections, Turkish exports to Saudi Arabia fell by 98% in t he first 
quarter of 2021 compared to the same period of the previous year.  
4.452.   Evidently, Turkey is seriously concerned about these trade restrictive practices of Saudi 
Arabia against Turkish goods. We believe the regular treatment of Turkish products at Saudi  customs 
are in clear violation of, inter alia , the Articles 5.1.1 and 5.1.2 of TBT Agreement on non -
discrimination, and avoidance of unnecessary barriers to trade. As is well known, the TBT Agreement 
is intended to achieve a balance between upholding legi timate regulatory policy objectives and 
avoiding the creation of unnecessary obstacles to trade. TBT Agreement also aims to prevent the 
Members from creating arbitrary or unjustifiable discrimination between countries in international 
trade. In this respec t, we would like to remind Saudi Arabia once again that regulations and 
conformity assessment procedures should not be more strict, or be applied more strictly than 
necessary and access for suppliers of like products originating in the territories of the M embers 
should not be less favourable than those accorded to suppliers of like products of national origin or 
originating in any other Member country. Therefore, Turkey invites Saudi Arabia to bring its policies 
and practices concerning Turkey in line with its WTO TBT obligations and to ensure smooth flow of 
trade for Turkish products.  
4.453.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. We take note of the concern raised by Turkey and want to assure that the Kingd om of 
Saudi Arabia always affirms its commitments to all trade rules stipulated in the WTO agreements. 
In response to the concern, as we did on several occasions both bilaterally and here in this house at 
the multilateral level, there are no restrictions o r discrimination imposed on Turkish imports to Saudi 
Arabia. We would like to emphasize once again that our borders and markets are open to all goods 
and products, including those coming from Turkey. In addition, we would like to reiterate that Saudi  
autho rities do not interfere in consumers' preferences nor encourage buyers to trade with products 
based on its country of origin.  
4.1.3.65   India - Plain Copier Paper (Quality Order) 2020, G/TBT/N/IND/140  (ID 681113) 
4.454.   The representative of Indonesia  provided the following statement. Indonesia appreciates 
India for the discussion in the virtual bilateral meeting on February. However, Indonesia regrets that 
India is yet to provide substantive response to Indonesia's concern. Indonesia remains concerned  
about the provisions stated in Plain Copier Paper (Quality Control), Order 2020. The certification 
shall be carried out only by Bureau of Indian Standards (BIS) based on the Conformity Assessment 
Regulation 2018 through the Scheme 1 of Schedule -II which s hall require factory visit, sampling and 
testing of the product as well as licensing procedures. Indonesia regrets that India has ignored the 
current pandemic situation that made factory visit an impossible task to do due to travel ban and 
social distancin g policy. Therefore, Indonesia urges India to consider the use of remote assessment 
in conducting factory visit or any relaxation policy as a means to facilitate trade and minimize 
technical barrier to trade, particularly in this difficult time. Indonesia would like to reiterate its 
previous statement where Indonesia is of the view that the concerned regulation has impacted and 
become a trade barrier for the exporters as there is no clarity regarding the mechanism of the 
regulation. Therefore, Indonesia req uests India to postpone or provide sufficient transition time to 
allow industries to comply with the regulation. Indonesia urges India to adopt available International 
Standard as a basis for testing method. Indonesia is also aware that India through the M inistry of 
Commerce and Industry had published mandatory implementation of Plain Copier Paper (Quality 
Control) Order 2020 Regulation on 5 June 2020. This regulation will come into force after six months 
from the date of its publication, which is 5 Decembe r 2020. In this regard, Indonesia kindly reminds 
India to notify this technical regulation to WTO TBT, as the addenda of the previous notification.  
4.455.   In response, the representative of India provided the following statement. We thank 
Indonesia for its intere st and the statement. At the moment we are engaged with the concerned 
ministry and will revert with a reply soon.  
 
113 For previous statements follow the thread under ID 681. G/TBT/M/84  
 
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  4.1.3.66   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20,  
G/TBT/N/IND/20/Add.1,  G/TBT/N/IND/40,  G/TBT/N/IND/40/Rev.1  (ID 133114) 
4.456.   The representative of Indonesia  provided the following statement. Indonesia thanks India 
for having a bilateral meeting with Indonesia at the side -line of the TBT Committee meeting on 
26 February 2021. However, until this time Indonesia regrets that Indi a fails to provide response to 
our concern. As Indonesia is aware, based on our knowledge, India has imposed loyalty or marking 
fees for tyre products with IS marking. Indonesia remains concerned that the imposition of marking 
fees is burdensome and has be come unnecessary obstacle to trade. The imposition of marking fees 
is also having no legitimate justification with no strong relation to protection of human health, safety 
or prevention from deceptive practice. At the same time, Indonesia is also aware tha t India has 
imposed import restriction for certain types of tyre. This import restriction provisions were issued 
shortly after India banned the importation of tyre products to India for a period of six months as in 
notification no. 12/2015 -2020 dated 12 Ju ne 2020 regarding Amendment in Import Policy of Tyres. 
These policies have impacted Indonesia's export and disrupted the flow of goods to India. Indonesia 
is of the view that this policy is not in line with non -discriminatory principle as set out in Articl e 2.1 
of the TBT Agreement. Indonesia therefore urges India to comply with the TBT Agreement, 
particularly with non -discrimination principles as stated in Article 2.1 of TBT Agreement. Indonesia 
is looking forward to India's response on this issue and requ ests India to review the policy to ensure 
compliance with non -discriminatory principle.  
4.457.   In response, the representative of India provided the following statement. India has noted 
the concern raised. At the moment, we are engaged with the concerned ministry  and will revert with 
a reply soon.  
4.1.3.67   Viet Nam - Cybersecurity Measures (ID 544115) 
4.458.   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 Members have raised in order to ensure the Cybersecurity Law 
is implemented in the least trade -restrictive manner p ossible. Does Viet Nam have any updates to 
share with us on the status of the draft decree.  
4.459.   The representative of Canada  provided the following statement. Canada would like to 
support the points raised by other delegations related to Viet Nam's cybersecuri ty measures.  
4.460.   The representative of Australia  provided the following statement. Australia would like to 
register its ongoing interest in this matter and also refer to our previous statements.  
4.461.   The representative of the European Union  provided the following s tatement. The European 
Union shares the Member's concerns on the Vietnamese Cyber Security 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 updated informati on on the adoption of Implementing Decree on 
Cybersecurity and invites Viet Nam to seriously consider EU concerns and continue the dialogue to 
ensure alignment to international best practices. We would also appreciate information on any other 
draft impleme nting measures and on whether comments from interested parties, including industry 
and stakeholders, are considered. The European Union kindly requests that Viet Nam notifies the 
Cyber Security law, the draft Implementing Decree and any other planned imple menting measures 
to the TBT Committee, in accordance with Article 2.9 of the TBT Agreement and that it gives sufficient 
time for comments. The European Union encourages Viet Nam to develop and implement Cyber 
Security measures in full respect of WTO princi ples, such as non -discrimination and proportionality 
and to take into consideration available international standards and practices.  
4.462.   In response, the representative of Viet Nam  provided the following statement.  We would 
like to reiterate that the Law on C ybersecurity and the draft Decree for implementing certain articles 
of this Cybersecurity Law have not regulated technical requirements with regard to information 
technology products or equipment. Our process has been transparent with an open mind. All 
stakeholders' comments have been fully taken into consideration. The draft Decree for implementing 
 
114 For previous statements follow the thread under ID 133 . 
115 For previous statements follow the thread under ID 544 . G/TBT/M/84  
 
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  certain articles of this Cybersecurity Law has been submitted to the Prime Minister and will be issued 
soon.  
4.1.4   Brief report from Secretariat on beta version of th e TCD  
4.463.   The Secretariat  updated the Committee on the beta version of the Trade Concerns Database  
(hereafter "TCD" beta version), developed in 2021 jointly with the SPS Team and IT Division. It was 
recalled that the TBT Committee has maintained an information management system (the TBT IMS) 
since 2009  and, as  technology had developed, the platform needed to be replace d. The Secretariat 
was currently working on replacing the TBT IMS in a staged process. The TCD was the first part of 
that process. It would replace the TBT IMS search function for STCs. It ha d several advantages 
compared to the old system. First it integra ted TBT and SPS information in one place  (previously 
this was contained in separate IMS databases ). Second, it enabled Members to easily access and 
consult the integrated history of a trade concern, including all statements and related notifications  
(all in one place) . Third, it improved upon the search functions previously available. It would also 
allow for more precise searches,  including  by Member, by meeting, keywords, products  (and this 
across both TBT and SPS  STCs) . The Secretariat stressed that the d atabase improved on access 
already available to Members and the public on STCs through the TBT and SPS IMS and the minutes 
of meetings. Since the last meeting of the Committee, the Trade Concerns database included all 
historical data on TBT STCs in all thr ee official WTO languages. The Secretariat welcomed any 
feedback.   
4.464.   The representative of the European Union  asked if her delegation 's statements were in the 
public domain.  
4.465.   The Secretariat  clarified that what was available on the TCD was not the statements that 
had been uploaded to eAgenda, but the records of the STC discussions that were in the minutes . So, 
while indeed, the information and access to the TCD was publicly available, the pla tform enabled a 
better  access to the information contained in the minutes when made public (derestricted) according 
to currently existing procedures.  
4.466.   The representative of the United States  noted that the TCD provided easier access to the 
public for state ments made. It appeared that, with eAgenda, the minutes were more fulsome that 
they had been in the past. This could perhaps be a topic discussed in a "Friends of eTools" group 
with interested Members. She proposed that such a meeting would have three diff erent purposes: 
(i) informational – so that Members and users of the platforms would be better informed; (ii) for 
interested delegations, the Friends of eTools group could be used to collaborate and exchange 
experiences; and (iii) it would provide a vehicl e for feedback to the Secretariat. Discussions in the 
Group could include several topics, such as specific concerns database, ePing and eAgenda.  
4.467.   The representative of Mexico  raised similar points to those of the US and the EU. Matters 
were still being disc ussed internally and Mexico expressed a wish to participate in the Friends of 
eTools group.  
4.468.   The Chair welcomed Members ' interest in a Friends of eTools Group. He invited any Member 
that would like to be part of such a group to flag this interest to the Sec retariat 
(una.flanagan@wto.org ). 
4.2  Exchange  of Experiences  
4.2.1   Transparency  
4.469.   The Chair  recalled that the Committee 's Annual Review (G/TBT/45 ), contains details on 
Members' st atements of implementation  under Article 15.2 .  
4.470.   The Secretariat  noted that ePing continued to be of interest for a variety of stakeholders and 
had around 14,000 subscribed users, around half from the public sector, 40 % from the private sector 
and the remai nder from NGOs and academia. Enquiry Points and other officials tasked with managing 
notifications could request enhanced access to the system, allowing them to use ePing to reach out 
to domestic subscribers, as well as other Enquiry Points. In addition, t hey could post, on a voluntary 
basis, comments and replies on notifications via ePing's international forum, in line with the TBT G/TBT/M/84  
 
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  Committee's 8th Triennial Review recommendation in this regard. The Secretariat continued to 
receive a high number of requests  for training on transparency generally and on ePing specifically. 
Since the beginning of the year, the Secretariat had conducted a series of virtual training workshops 
for public and private stakeholders in seven countries, often in collaboration with the ir Enquiry 
Points. These included ePing workshops for the private sector in the Bahamas and St. Lucia as well 
as a training programme on transparency and ePing for South African trade officials and regulators, 
which would be complemented by an additional m odule for the private sector. In addition, the 
Secretariat had collaborated with ePing partner UN Department for Economic and Social Affairs 
(UNDESA) to deliver ePing training for stakeholders in Bangladesh, Bhutan and Vanuatu, in the 
context of a programm e for LDCs in the process of graduation. Furthermore, the Secretariat had 
delivered a series of training sessions in the context of an overarching ITC project for Viet Nam, 
which saw the launch of ePing in Vietnamese. This was an innovative project which b rought together 
government officials, SPS/TBT Enquiry Points, the trade promotion agency and the Foreign Trade 
University, with the aim of assisting MSMEs in accessing export markets.  
4.471.   The Secretariat had conducted a survey earlier in the year to receive us er feedback on ePing. 
A document summarizing the results and highlighting key takeaways would be issued once the 
analysis of the more than 1400 replies was finalized .116 Preliminary findings suggested  that ePing 
was highly appreciated by users. At the same time, useful suggestions had been made for possible 
enhancements, including an ePing App. Finally, the Secretariat had started work on a revamped and 
more integrated online platform, which would bring under one roof the various online tools, including 
the TBT IMS, the TBT NSS, ePing and the new Trade Concerns database. The Secretariat was 
planning to invite interested Members to provide inputs and suggestions during the development of 
this integrated platform. Considering interest expressed in the Committee  for a "Friends of eTools" 
group, the Secretariat would aim to schedule a first meeting in July.  
4.472.   The representative of Viet Nam  provided information on the launch of the Vietnamese version 
of ePing. She explained that as ePing was recognized as a useful to ol for Vietnamese enterprises, 
particularly SMEs, the system was being disseminated to them as well as to ministerial and local 
TBT Points since 2017. While Vietnamese enterprises had expressed interest in the system, language 
issues had made it difficult for them to assess the content of notified measures. In the context of an 
ITC project with Vietrade , Viet Nam had indicated its interest in addressing this language barrier. In 
response, ITC and WTO had facilitated the completion a Vietnamese version of ePing, which had 
been officially launched on 29 April with the participation of Vietnamese Government agencies, 
associations, SMEs, universities and related organizations as well as the ITC and WTO. The Foreign 
Trade University students were also contribut ing to the project by translating TBT and SPS 
notifications into Vietnamese, which were then circulated to SMEs via ePing. The representative 
indicated that the number of registered ePing users in Viet Nam had risen considerably in 2021. 
However, the numbe r was still small compared to the large number of SMEs in Viet Nam and it was 
hoped that more would be subscribing following this initiative. She also expressed Viet Nam's 
gratitude towards the ITC and the WTO for their support with the project.  
4.473.   The Secretariat  updated the Committee on COVID -related notifications . To date (June 2021), 
153 COVID -related TBT notifications had been submitted since the pandemic started in early 2020. 
This represented about 40% of the total number of COVID -related notifica tions to the WTO. As many 
as 31% of the TBT notifications had been submitted by Brazil. A wide range of products were covered 
in the TBT notifications, including PPEs, medical equipment/supplies, foods, live animals. Most of the 
notifications were on confo rmity assessment procedures and about trade -facilitating measures 
(providing more flexibility) e.g., using remote assessments technologies, electronic certification, 
mutual or unilateral recognition. Many notifications were temporary (generally for six months or one 
year) – they were mainly about streamlining certification procedures, ensuring the safety of medical 
goods, and making food available by relaxing technical regulations. The Secretariat would continue 
to monitor COVID -19-related measures by maint aining its dedicated webpage . 
4.2.2   Conformity assessment procedures  
4.474.    The Chair recalled that since the last meeting of the Committee, new submission s had been 
received from  Colombia a nd South Africa ; these were  contained in document s JOB/TBT/406  and 
JOB/TBT/407 , respectively. There was now a total of eight submissions (also from the European 
Union in JOB/TBT/322 , the United States in JOB/TBT/326 , Australia in JOB/TBT/347 , Japan in 
 
116 G/SPS/GEN/1933 -G/TBT/GEN/317 . G/TBT/M/84  
 
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  JOB/TBT/349 , Canada in JOB/TBT/358 , and China in JOB/TBT/391 ). He noted that the most recent 
discussions on the development of guidelines had been  summarized in the Aide Memoire, 
JOB/TBT/273/Rev.8  circulated on 26 May.  
4.475.   The representatives of Colombia  and South Africa  introduced their submission (for the 
details, see JOB/TBT/406  and JOB/TBT/ 407, respectively). Co lombia asked the Chair about next 
steps.   
4.476.   The Chair said, regarding further progress, that further submissions from Members were 
welcome. He noted that there were currently eight submissions on the table from a range of Members 
in the Committee, and one a pproach, depending upon Members' views, would be to ask the 
Secretariat to compile a basic outline, an "elements " document for comments from the Membership. 
This could be due mid -October and discussed at the November meeting.  
4.477.   The representative of the European Union  recalled the importance of the development of 
non-prescriptive practical Guidelines on Conformity Assessment. They would help regulators identify 
elements for conformity assessment they could be used in designing ap propriate and proportionate 
procedures. The European Union had presented a submission where it provided several ideas and 
proposals for consideration as a basis for the future Guidelines. She reiterated that this work should 
not be prescriptive and should take into account different approaches to conformity assessment 
across the Membership. The European Union appreciated that also Colombia and South Africa had 
recently presented submissions.  
4.478.   The representative of the United States  joined the EU in thanking  Colombia and South Africa 
for the proposals today. In terms of a way forward she was of the view that more clarity was needed 
in terms of the timing. The Committee was currently holding a very long meeting; there was also 
the Triennial Review to consider in November. She stressed the limitations to the virtual format.  
4.479.   The representative of Colombia  shared the comments made by the United States on the 
potential difficulties faced by delegations when tackling both the conformity assessment guidelines 
as wel l as the Ninth Triennial Review in 2021; this could lead to a burdensome agenda, also 
considering that the next regular meetings would fall just weeks before the Ministerial Conference 
(MC12).  
4.480.   The representative of South Africa  said that her delegation, to o, would need more time to 
work on the Guidelines, and to keep up with work on the Triennial Review.  
4.481.   The representative of the United States  noted, in addition, that there were ongoing bilateral 
meetings that were also being done virtually – and this entai led more effort than holding them in -
person in Geneva.  
4.482.   The Chair understood the concerns with respect to workload. He suggested that the 
Committee revert to conformity assessment after the Triennial Review, perhaps at an informal 
meeting in February 2022.  He noted that it was, nevertheless, possible to work in parallel on both 
topics ( Triennial Review and conformity assessment guidelines) as had been demonstrated by 
Members ' various inputs to date. He sought again Members ' guidance on the notion of an elem ents 
paper: this could, perhaps, be something that the Committee could look at in February 2022? If so, 
the Committee could request the Secretariat to start work on the elements given that there were 
currently eight submissions from a range of Members.  
4.483.   The representative of the European Union  noted that delegations might have to show more 
discipline in the discussions on STCs as that, too, took up a lot of time – and took away resources 
from a discussion of more substantive issues. The EU was supportive of a discussion in February and 
an elements paper form the Secretariat as soon as possible to give time for internal discussions.  
4.484.   The representative of Canada  said that the Chair 's proposal made sense. There was need 
for time to consider both the contents of  the elements paper as well as to have a dedicated discussion 
of it. He agreed with previous speakers about the uncertainty of scheduling on the margins of existing 
meetings given the length that it was taking the Committee to get through the STC part of t he 
agenda. Canada 's view was that the Chair 's proposal was pragmatic: to schedule the discussion for 
next year was probably the best way of approaching it.  G/TBT/M/84  
 
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  4.485.   The representative of the United States  supported the comments made by Canada  and w hile 
she appreci ated what the EU was saying, it was difficult to control the time of the STC discussion. It 
was preferable for the US to focus on the conclusion of the Ninth Triennial Review.  
4.486.   The Chair proposed that the Committee hold a dedicated informal meeting next ye ar (2022) 
to discuss its work on conformity assessment, and that this meeting be informed by an elements 
paper prepared by the Secretariat to be provided at the end of the current year (2021). This would 
enable Members to focus on the Triennial Review duri ng the rest of the year, and preparations for 
MC12. The Secretariat would follow up in due course with a date for the dedicated informal. The 
Chair stressed that this approach needed to be seen as just another step in a road in the Committee 's 
work on the guidelines; it would certainly not lead to the adoption  of the Guidelines in February 2022 
– it was simply an opportunity to discuss where the Committee was at, and, hopefully, to welcome 
further proposals from Members as well as  comments on the elements p aper. He asked if the 
Committee could accept the proposal. It was so agreed .   
5  TECHNICAL COOPERATION ACTIVITIES  
5.1.  The Secretariat  updated the Committee on its technical assistance activities. It was noted that 
on 27 May , the Secretariat had  organized a Virtual Technical Assistance regional activity for English -
speaking African countries . This had been a roundtable  with 7 0 participant s from 19 countries in the 
region  with participation from WHO (on Covid -19 and TBT ), ARSO  (the African Organization from 
Standardization ). A similar formula for virtual roundtables would follow in other regions.  It was also 
noted that ITTC had submitted to  beneficiary Members a questionnaire on their technical assistance  
priorities for the next two years  (2022-2023). As in previous years , TBT featured among the top 
priorities for Members for the next two years.  
6  OBSERVERS  
6.1  Updates  
6.1.  The representative of the BIPM provided an update. The full content of this update is contained 
here. 
6.2  Pending Requests  
6.2.  Regarding pending requestions for observer status , the Chair  recalled that documents 
G/TBT/GEN/2/Rev.16  and RD/TBT/1/Rev.8  provide d updated information on observers in the TBT 
Committee, including pending requests. He noted that two new requests ha d been received in 
(2021);  one from the Arab Industrial Development, Standardization and Mining Organization 
(AIDSMO) and the other from the United Nations Institute for Training and Research (UNITAR). He 
said that, regarding previous requests for observer status in the Committee  – and SMIIC in particular  
– further to a request from Turkey , he had  reach ed out to some  Members  to try to find a solution to 
the current situation . However, he was not aware of any further information or developments on 
this matter  and he had no information that would lead him to belie ve that the situation ha d changed 
from where the Committee stood at the last meeting.  
6.3.  The representative of Turkey  thanked the Chai r for his efforts. She welcomed  the opportunity 
to correct some misunderstandings about the SMIIC so that Members could make a well -informed 
decision on the SMIIC's request to have an observer status at the TBT Committee. Turkey  underst ood 
from the latest intervention by the US (at the last TBT Committee m eeting ), that the US considered 
the SMIIC a regional metrology organization and  had expressed objections on the basis that two  
globally recognized metrology organizations (the BIPM and the OIML) already had been granted 
observer status.  However, the SMIIC submission and mandate were not limited to metrology. Being 
an affiliated institution of the Organization of Islamic Cooperation (OIC), the SMIIC aim ed at 
developing infrastructures by establishing uniformity in standardization, conformity assessment, 
accreditation and metrology activities, and thus eliminating technical barriers to trade among its 
members.  The SMIIC also had important activities in the field of halal which Turkey thought deserved 
more attention as this issue was becoming a frequent item on  the agenda of the TBT Committee. 
The SMIIC work ed on the adoption of a single -halal standard and the establishment of a trust -worthy 
certification system among the OIC countries to avoid unnecessary technical barriers to trade. The 
SMIIC ha d already issue d halal standards and provided guidelines for halal certification accreditation. G/TBT/M/84  
 
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  In this respect, the SMIIC's work and expertise held great potential to provide significant support 
for halal trade facilitation. Turkey stated once again that the SMIIC st ood ready to answer all queries 
from Members regarding its request for observer status at the Committee.  
7  DATE OF NEXT MEETING  
7.1.  The Chair recalled three further points117: 
a. Any comments on the update of advance draft Chair's report on our Ninth Triennial Review 
Informal meetings, emailed to the delegates' contacts list last Friday , were due by Friday 
11 June in mark -up please.  
b. Further to earlier discussions, the Secretariat would provide a communication by the end 
of the week with a date for the informal d iscussion on conformity assessment procedures 
for February 2022. Also, as part of this, communication, we will include the details for an 
informal meeting for the "Friends of eTools" for TBT.  
c. In relation to the Ninth Triennial Review, any Member that wishe d to provide further 
information to elaborate or revise their proposal already on the table were asked to submit 
this information by 15 June 2021.  
7.2.  The Chair recalled that the next regular meeting of the Committee was scheduled for 10-12 
November 2021. This  regular meeting would  be preceded by an informal meeting on the Ninth 
Triennial Review on 8 -9 November 2021.  The full schedule of meetings for 2021 was contained in 
JOB/TBT/364/Rev.2  and the preliminary meeting dates for 2022 were contained in JOB/TBT/408 . 
__________  
 
117 Subsequent to the meeting the Chair issued ICN/TBT/4 .