RESTRICTED  
  
G/TBT/M/87  
 
30 September  2022 
(22-7395) Page: 1/128 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 13-15 JULY  2022 
CHAIRPERSON: MR. ANWAR HUSSAIN SHAIK  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ .......................  1 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................  4 
2.1   Specific Trade Concerns  ................................ ................................ ..............................  4 
2.1.1    Reported progress on STCs  ................................ ................................ .......................  4 
2.1.2    New Specific Trade Concerns  ................................ ................................ .....................  4 
2.1.3    Previously raised concerns  ................................ ................................ ......................  15 
2.2   Exchange of Experiences  ................................ ................................ .........................  120 
2.2.1    Transparency  ................................ ................................ ................................ ...... 120 
2.2.2    Conformity Assessment Procedures  ................................ ................................ ........  123 
2.2.3    Regulatory Cooperation between Members (MSMEs)  ................................ ................  125 
2.2.4    Covid -19 ................................ ................................ ................................ ............  125 
2.2.5    Other Matters  ................................ ................................ ................................ ...... 126 
3   TECHNICAL COOPERATION ACTIVITIES  ................................ ................................ . 127  
4   OBSERVERS  ................................ ................................ ................................ ............  127  
4.1   Updates from Observers  ................................ ................................ ..........................  127 
4.2   Pending requests  ................................ ................................ ................................ .... 127 
5   OTHER BUSINESS  ................................ ................................ ................................ ... 128  
6   DATE OF NEXT MEETING ................................ ................................ .........................  128  
 
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/2 3. 
1.2.  The representa tive of Ukraine  expressed his delegation’s gratitude for Members’ assistance to 
Ukraine, for their leadership and unwavering support in the hardest possible time. According to the 
Preamble of the WTO Marrakesh Agreement, Members  needed to work together to improve the 
welfare of people around the world , raise living standards, create jobs and improve people's lives by 
"entering into reciprocal and mutually advantageous arrangements directed to the substantial 
reduction of tariffs and other barriers to trade and to the elimination of discriminatory treatment in 
international trade relations" ; and, also – to "develop an integrated, more viable and durable 
 
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/87  
 
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  multilateral trading system". These noble goals and principles of work at the WTO  had been – and 
were curre ntly – horrendously destroyed by the Russian aggression.  
1.3.  Once more, Ukraine emphasized that Russia's invasion of Ukraine undermined the established 
work of the multilateral trading system, hindered the development of and people's welfare in 
developing and  least developed countries (LDCs), as well as impaired the proper functioning of 
international organizations, the WTO in particular. The war launched by the Russian Federation on 
Ukraine had caused immense suffering and destruction and the national system for the development 
of technical regulation had been seriously affected by the war. Many employees had been forced to 
work under extremely harsh circumstances. Experts from the competent bodies of Ukraine in the 
sphere of technical regulation had been rede ployed to perform their official duties in other regions 
of the country.  
1.4.  81 conformity assessment bodies were designated in Ukraine to ensure conformity assessment 
procedures with the requirements of technical regulations as a third party prior to Russia' s full-scale 
invasion of Ukraine. After the introduction of martial law in Ukraine these bodies had inquired about 
their ability to conduct procedures for assessment of conformity to technical regulations during the 
martial law regime in Ukraine. As of 12 July 2022, only 44 of the 81 designated bodies, located in 
different regions of Ukraine, had informed the national authority in the TBT sphere and confirmed 
the capability to continu e to fully conduct conformity assessment procedures within their permanent 
locations. No information had been  received from the remaining 37 bodies located in regions, part 
of whose territory was currently under occupation and constant shelling. Against th is backdrop, the 
national competent bodies continue d to diligently fulfil their professional obligations to ensure that 
technical regulations, standards and conformity assessment procedures d id not create unnecessary 
obstacles to trade.  
1.5.  Regarding export s of Ukrainian products, the representative of Ukraine was grateful to its 
partners for the measures taken to resume Ukraine's ability to produce and export of goods. Ukraine 
recalled that the WTO , as well as other international institutions , had been  create d to promote 
peaceful cooperation between governments on a variety of issues. The Russian Federation by its act 
of aggression against the sovereignty of Ukraine and its sovereignty ha d ruined this underlying 
purpose. In this regard , the representative of U kraine inform ed Members that Ukraine ha d requested 
ISO, the International Bureau of Weights and Measures  (BIPM) , International Electrotechnical 
Commission  (IEC) , International Organization of Legal Metrology  (OIML) , European 
Telecommunications Standards In stitute  (ETSI)  to unequivocally condemn the aggressive actions of 
the Russian Federation, noting that they represent ed a clear violation of Ukraine`s sovereignty and 
territorial integrity , and that these actions ran contrary to the principles enshrined in these 
organizations.  
1.6.  The representative of Canada  strongly condemn ed Russia's unjustifiable and unprovoked 
invasion of Ukraine. The attacks were causing widespread humanitarian consequences. This was not 
just an attack on Ukraine, this was an attack on int ernational law including UN Charter as well as 
democracy, freedom and human rights.  
1.7.  The representative of Australia  condemned  in the strongest possible terms Russia's unprovoked 
and unjustified attack on its neighbour , Ukraine. The invasion was a gross violation of international 
law and the UN Charter. Australia  called on Russia to withdraw its forces from Ukrainian territory. 
Australia deeply regret ted the already high number of casualties , in particular the Ukrainian civilians , 
killed so far in the conflict.  
1.8.  The representative of  the United States  thank ed the delegate from Ukraine for his statement 
and reiterate d her country’s strong support for Ukraine. The United States condemn ed Russia's 
premeditated and unprovoked attack on Ukraine , as well as the actions of the Belarus regime which 
was complicit.  The United States called upon Russia to immediately cease the use of force aga inst 
Ukraine and refrain from any further use of force against any UN member State.  The actions of 
Russia were incompatible with the rules-based system  that the international community as a whole 
had built; Russia’s aggression undermine d the rights of Ukra ine in the WTO  and was fundamentally 
incompatible with the values and principles  of this organization . 
1.9.  The representative of the European Union  stress ed, like others in the room, that the Russian 
Federation's invasion  of Ukraine was a flagrant violation of  international law and the rules -based G/TBT/M/87  
 
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  international order  and had effects that spread well beyond Ukraine's borders . The European Union 
urged Russia to stop its indiscriminate attacks against civilians and civilian infrastructures and to 
immediately and unconditionally withdraw its troops and military equipment from the entire territory 
of Ukraine within its internationally recognized borders. As reflected in the EU and Partners March 
Joint Statement to the General Council, and in the recent G7 Leaders' Communiqué, the EU and its 
partners continue d to fully support Ukraine's sovereignty and territorial integrity. The EU and its 
Partners restate d their unity in respect of sanctions against Russia and on providing short - and long -
term reconstruction assistance to Ukraine. The EU stood by Ukraine.  
1.10.   The representative of the United Kingdom  condemned Russia’s recent aggression against 
Ukraine. Since Fe bruary , Russia ha d continued its unprovoked and illegal aggression  against a  
democratic State and a fellow Member of this Organization. Russia must urgently de -escalate and 
withdraw its troops and cease its violations of international law. The UK would con tinue to work with 
our partners across the multilateral system to condemn Russia's actions and isolate  it on the 
international stage.  
1.11.   The representative of New Zealand  unequivocally condemned  the unprovoked and unjustified 
attack by Russia on Ukraine. The actions of President Putin were a great breach of international 
rules; the use of force to change borders  was strictly prohibited under international law, as was the 
targeting of civilians. New Zealand was appalled by reports of the devastating and indiscr iminate 
attacks on Ukraine's population by Russian troops, including evidence of crimes against humanity 
and war crimes, as well as the destruction of civilian infrastructure including hospitals, schools, and 
homes. New Zealand  support ed and would  spare no  effort in holding those responsible for this 
aggression to account. New Zealand remain ed united with the international community to maintain 
pressure on Russia and hold those responsible for violations of humanitarian and international law 
to account.  New Zealand had repeatedly called for President Putin to act consistently with 
international obligations, cease Russia's invasion of Ukraine, withdraw troops and return to 
diplomatic negotiations as a pathway to  resolve the conflict. New Zealand’s thoughts were with the 
people of Ukraine and with the Ukrainian Community, particularly in light of the distressing reports 
of atrocities against civilians.  
 
1.12.   The representative of Japan  said that Russia's aggression against Ukraine was an infringement 
of the sovereignty and territory of Ukraine which constitute d a clear violation of international law ; it 
challenged the foundation of international order. Japan ha d no tolerance towards this. Russia’s  action 
was an outrageous act  that disrupt ed supply chains and cause d concerns on food security. Japan 
condemn ed Russia's aggression in the strongest possible terms and urge d Russia  to cease its military 
operations in Ukraine and  to withdraw its forces immediately. Japan continue d to stand in solidarity 
with Ukraine and its people and  to cooperate with the Members of the international community to 
improve the situation.  
1.13.   The represent ative of the Republic of Korea  expresse d concern about  Ukraine's inability to 
fully participate in the WTO TBT Committee and the related fields and join ed others in strongly 
condemning Russia's invasion of Ukraine as a violation of principles of the UN Cha rter and 
international law. The use of force that cause d innocent casualties could not be  justified under any 
circumstances. Ukraine's territorial sovereignty and political independence had to be respected.  
1.14.   The representative of  Switzerland  condemn ed the Russian military aggression on Ukraine in 
the strongest possible terms. It was a violation of international law; it violate d the prohibition of the 
use of force and the territorial integrity and sovereignty of Ukraine. Switzerland call ed on  Russia to 
respe ct its international obligations and to reverse its actions as well to withdraw its troops and to 
contribute to the de -escalation. Switzerland call ed on  all actors to respect international law including 
international humanitarian law.  
1.15.   The representative o f Costa Rica  expressed solidarity  with the people of Ukraine  for the 
unjustified attack by Russia. The human tragedy that millions of  families were suffering was 
unthinkable for a country like Costa Rica with a democratic and peaceful tradition. The impact  on 
world trade was obvious and this was an issue that had to be addressed at the WTO . The impact of  
the war was generating consequences in  both the short and long term ; there was contamination of 
the soil, and human lives were being affected  – and this wa s when many people were already 
suffering from the food crisis. Costa Rica would  continue to be a strong defender of multilateralism 
and international architecture that serve d peace, security, sustainable development and protection 
of human rights. Costa R ica called for dialogue and  respect for the rule of law.  G/TBT/M/87  
 
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  1.16.   The representative of  the Russian Federation  repeated  his delegation ’s view that the 
consideration of matters of global or regional security concerns, the humanitarian situation, the UN 
Charter , enforcement or compliance, d id not fall under the mandate of  the TBT Committee – more 
the WTO itself. Russia was ready to consider the situation in  Ukraine in relevant UN Agencies and 
Bodies. The unilateral trade restrictions measures introduced by Members that ha d intervened in the 
Ukrain ian issue fell under the Mandate of the WTO, these measures represent ed a violation of WTO 
rules, and undermine d the multilateral trading system and the rules -based order. Also, with due 
respect , the representative of Russia recalled that according to Rule 17 on the Rules of Procedure 
for meetings of the General Council, contained in document WT/L/161 , whenever the debate 
between Members steer ed away from the adopted agenda, it was the responsibility of the 
Chairperson of the meeting to call a speaker to order if the remarks of the speaker were not relevant. 
From our point of view, the remarks of delegations were not relevant, not just for this Committee 
but for the WTO itself.  
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
2.1.1   Reported progress on STCs  
2.1.  The delegation of the European Union thank ed the Kingdom of Saudi Arabia for the good 
cooperation on ceramics.2 The STC  had not been raised during the current meeting as a TPR 
investigation was also underway. The EU noted that a lot of progress had been made due to Saudi's 
engagement, including many bilateral  meetings . Despite certain things still needing to be 
implemented , positive developments were observed and the EU hoped that it would not need to 
raise the concern in the future.  
2.2.  The delegation of Australia  thanked the United Kingdom for its constructive engagement on 
the issue of STC 663  to date.3 In light of the UK' s cooperative work in addressing their concerns 
regarding wine labelling requirements , Australia had decided to cease raising this STC for the time 
being and that they were working towards a permanent resolution. Australia looked forward to 
continued engag ement with the UK to ensure permanent resolution in implementing in a timely 
manner.  
2.1.2   New Specific Trade Concerns  
2.1.2.1   China - Key Points and Judgment Principles of GMP Inspection for Cosmetics; 
Safety and Technical Standards for Cosmetics (2022); Technical Guid elines for Children's 
Cosmetics, G/TBT/N/CHN/1673 , G/TBT/N/CHN/1674  (ID 7494) 
2.3.  The delegation of the United States  provided the following statement. The United States 
appreciates that China notified the TBT Committee of two new draft implementing measures for the 
Cosmetics Supervision and Administration  Regulation (CSAR): the Key Points and Judgement 
Principles of Good Manufacturing Practice (GMP) Inspection for Cosmetics ( G/TBT/N/CHN/1673 ), and 
the Safety and Technical Standards for Cosmetics ( G/TBT/N/CHN/1674 ). We submitted comments 
to China in response to your notifications on 24 June 2022. However , we question China's 
commitment to giving meaningful consideration to stakeholder input given the timelines provided 
for implementation and the lack of an explanation as to why China deems relevant international 
standards, guides, or recommendations inapp ropriate to meet its regulatory objectives. First, we are 
concerned that while China provided a 60 -day comment period for the GMP Inspection Points 
(G/TBT/N/CHN/1673 ), US industry has informed us that the measure went into force on 1 July 2022, 
only six days after the WTO comment period closed and just three months after a draft of the 
measure was first notified in China. The GMP Inspection Points are complex and add many new 
requirements for cosmetics companies that were not included in the related measure, Good 
Manufacturing Practices for Cosmetics ( G/TBT/N/CHN/1626 ). We ask that China delay its timeline 
 
2 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) 
(ID 698) 
3 United Kingdom - Wine labelling requirements at the  end of Brexit period  (ID 663 ). 
4 For previous statements follow the thread under ID 749. G/TBT/M/87  
 
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  for adoption and implementation of this new measure to allow sufficient time to conside r stakeholder 
comments, and to re -notify the measure if there are substantive updates.  
2.4.  Second, we ask that China clarify how the GMP Inspection Points will be used and if there will 
be flexibilities in how China assesses companies' conformity. For example,  Attachment 2 of the draft 
measure includes several inspection items for the entrusted production enterprise that in many 
companies are instead overseen within corporate headquarters or via contracts with third parties. 
Third, we are concerned that China i nformed the United States it will not notify the Technical 
Guidelines for Children's Cosmetics to the Committee. However, the Technical Guidelines do appear 
to introduce new requirements for cosmetic product use and ingredient restrictions that were not 
included in the Provisions for the Supervision and Administration of Children's Cosmetics 
(G/TBT/N/CHN/1615 ). Due to the mandatory nature of these two Technical Guidelines, we request 
that China notifies this measure to the TBT Committee. We also ask that once the measure has been 
notified with a reasonable period for comment and consideration of input, China provides a minimum 
of two years for companies to adapt their products or methods of production and an additional year 
to sell through products already in the market.  
2.5.  Fourth, we  ask that China clarify its timeline for public consultation, finalization, and 
implementation of updates to the Safety and Technical Standards for Cosmetics 
(G/TBT/N/CHN/1674 ). Although these standards update an existing measure, China has made 
substantive changes, including by its own count, amendment of 15 testing methods. Fifth, we ask 
that whenever China proposes an update to a standard, technical regulation or guideline related to 
CSAR, that China first considers whether the update is based on relevant international standard s, 
guides, or recommendations, and if not, that China provide an explanation for why those standards, 
guides, or recommendations are inappropriate to meet China's regulatory objectives. We thank 
China for its consideration and look forward to responses to our questions.  
2.6.  In response, the delegation of China  provided the following statement. As this is the first time 
a Member raises this concern in this Committee, China is listening to have an idea of what your 
concerns are and then we will contact the releva nt authorities and give you the reply.  
2.1.2.2   European Union - Proposal for a Directive of the European Parliament and of the 
Council amending Directive 2014/53/EU on the harmonization of the laws of the Member 
States relating to the making available on the mark et of radio equipment (COM/2021/547 
final), G/TBT/N/EU/859  (ID 7505) 
2.7.  The delegation of the United States  provided the following statement. We thank the EU for 
notifying its proposed amendment to the Radio Equipment Directive to the WTO TBT Committee. We 
provided comments to your not ifications on 15 March 2022. While we greatly appreciate your 
response to our comments on 5 May 2022, we have remaining concerns about the proposal as 
written and reported provisional agreement. We oppose the EU's decision to prescribe the USB Type -
C recep tacle within the regulation rather than allowing greater flexibility for mobile phone producers 
to use other receptacle interfaces that meet existing voluntary international standards. We also 
remain concerned about how a prescribed standard for mobile pho ne chargers will impact innovation. 
We have heard concerns from our industry stakeholders that future innovation for chargers, 
especially as it relates to energy efficiency, will be disincentivized under this proposal. While the EU 
has provided reassurance s that the notified draft provides a mechanism to allow for swift adoption 
of new or updated relevant technical specifications, we encourage the EU to recognize other 
international standards that support future innovation for chargers and provide up -to-date and safe 
solutions without the additional hurdle of prescriptive approval processes to adopt new technical 
specifications.  
2.8.  We again encourage the EU to specify technical regulations based on product requirements in 
terms of performance rather than design or descriptive characteristics. We also understand that 
there have been amendments to the original proposal included in the provisional agreement which 
expand the scope of the proposal, including to devices that were not contemplated under the impact 
assessment. We understand this has taken many stakeholders by surprise and leaves uncertainty 
as to the impact of this proposal o n the marketplace and barriers to trade. Finally, we ask the EU to 
 
5 For previous statements follow the thread under ID 750 . G/TBT/M/87  
 
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  provide any updates it might have on the expected timeline for finalizing and implementing this 
proposal.  
2.9.  In response, the delegation of the European Union  provided the following statement.  
Concerning United States' opposition to prescribe the integration of the USB Type -C receptacle for 
certain categories or classes of radio equipment, the EU would like to emphasize that, for more than 
ten years, the European Commission has supported a volu ntary approach. Though, it allowed to 
reduce the number of solutions from more than 30 to currently three, it has been ineffective in 
solving the lack of interoperability between radio equipment and chargers still causing inconvenience 
for consumers. The h armonized charging receptacle (USB -C) is a technology that has been and is 
developed by a consortium that includes major ICT manufacturers. Their specifications are open and 
translated into international (and European) standards. As regards the impact on i nnovation, the EU 
would like to highlight that the text includes provisions to act swiftly to update the technical 
requirements. Additionally, the proposed measures do not impede manufacturers to continue 
developing their own solutions, provided that they do not hamper the well -functioning of the 
harmonized charging solution (receptacle and communication protocol). Furthermore, the biggest 
upcoming developments in charging technologies are expected for wireless charging. For this 
purpose, the current text d oes not impose a harmonized solution but sets ground to introduce an 
efficient solution that will appear on the market.  
2.10.   Regarding the specifying of technical requirements in terms of design characteristics, this is 
the only possible way to achieve full int eroperability between radio equipment and chargers 
(consumer convenience) and reduce the proliferation of un -necessary chargers (environmental 
benefits). Combining a harmonized charging solution with the unbundling of the external power 
supply will deliver  results only if each category of products covered is equipped with the same 
receptacle. As for the amendments to the scope of the proposal, indeed, e -readers, earbuds, 
keyboards, mice, portable navigation systems, and laptops were added to enhance the ben efits of 
the proposal in terms of consumer convenience and environmental benefits. Impacts form the 
inclusion of earbuds and e -readers were assessed in the 2021 study. While the inclusion of other 
additional categories was not subject to an impact assessme nt, technical analysis revealed that there 
were no technical obstacles for their introduction in the scope of the measure. In addition, market 
developments confirm that USB -C receptacle is adapted and technically sound for application to 
these categories o f products. As far as laptops are concerned, a longer transition period (40 months 
compared to 24 months for the other categories) is foreseen in order to give manufacturers sufficient 
time to adapt to this inclusion. The formal adoption process by the Eur opean Parliament and the 
Council will take place after the summer. The text will enter into force following its publication in the 
Official Journal of the European Union.  
2.1.2.3   China - Measures for the Administration of Data Security in the Field of Industrial 
and Information Technology Sectors (For Trial Implementation) (ID 7516) 
2.11.   The delegation of Japan  provided the following statement. Japan has concerns about the 
"Measures for the Administration of Data Security in the Field of Industrial and Information 
Technology Sectors, " especially referring to the unclear relationships between many articles of the 
measures and the related provisions of the Cybersecurity Act. The Japanese government has already 
submitted comments including this point on the second public c onsultation in February 2022. 
Moreover, the definitions of "general data", "important data", and "core data" do not provide 
objective and specific criteria for classification. In addition, although Article 7 of the measures 
stipulates that the Ministry of Industry and Information Technology (MIIT) is to formulate a detailed 
inventory of "important data" and "core data", depending on the specifics of the detailed inventory 
and related regulations, it may have a significant impact on the businesses involved i n the industrial 
information field. Therefore, Japan would like to request that China utilize transparent procedures 
in formulating the detailed inventory, so that the opinions of stakeholders including foreign 
companies can be widely heard and reflected, and ensure that undue burden is not placed on 
business operators.  
2.12.   In response, the delegation of China  provided the following statement. In order to further 
promote the implementation of "Data Security Law", China has crafted the "Measures for Data 
Securit y Management in the Fields of Industry and ICT (For Trial Implementation)" . Based on the 
characters of industry and ICT, the measures has refined relevant requirements and provided more 
 
6 For previous statements follow the thread under ID 751 . G/TBT/M/87  
 
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  operational guidance for data processors of industry and ICT to fulfil their data security protection 
obligation.  
2.1.2.4   European Union - Draft Commission delegated regulation amending regulation 
(EU) 2019/2144 of the European Parliament and of the Council to ta ke into account 
technical progress and regulatory developments concerning amendments to vehicle 
regulations adopted in the context of the United Nations Economic Commission for Europe, 
G/TBT/N/EU/882  (ID 7527) 
2.13.   The delegation of China  provided the following statement. a. In this draf t notification, some 
of the UN regulations adopted by the EU were issued less than 15 months before implementation. 
For new models that are already under development, there is not enough time to make technical 
adjustments before 6 July 2022, and additional  configuration is required, which will lead to longer 
model development time and increased costs. For the certified models (in production), there is no 
time to upgrade the new version certificate before 6 July 2022, which will block sales on those 
original  certified vehicles after 6 July 2022. China proposes the EU to specify whether the upgraded 
regulation in the Annex, point (1) can apply to the buffer period of the transitional provisions of the 
individual UN regulations, or modify the implementation dat e in Annex, point (2) to leave enterprises 
more buffer time.  
2.14.   b. For vehicles with existing approval and new types of vehicles, the implementation time of 
some Annex II individual technical regulations in G/TBT/N/EU/882  is earlier than the implementation 
time of UN regulations, and t he transition period or exemption clause adopted are not explained 
accordingly, which has caused great trouble for enterprises to apply for EU type approval. This part 
of the regulations mainly influences the vehicles with existing approval (in production) . Automobile 
export enterprises in China has developed an upgrading plan according to UN single regulation 
requirements. If (EU) 2019/2144 was implemented on 6 July 2022, most certified vehicles exported 
to the EU would not meet the upgrading requirements,  causing risks of violation and affecting the 
sales market severely. China proposes the EU to further explain the difference between the 
implementation time of (EU) 2019/2144 Annex II and the transition period of the upgraded UN 
regulations adopted in Anne x I, and China hopes the EU to comply with UN WP.29 - The 1958 
Agreements. For example, UN R141 -01 series, although the implementation time for UN Regulation 
on certified models (in production) is also on 6 July 2022, Article 12.6 of the regulation provide s that 
parties shall continue to accept 00series type approval if the vehicle or vehicle system is not affected 
by 01 series. Under this condition, will the 00 series certificate of the certified models not be affected 
by the 01 series and remain valid aft er 6 July 2022?  
2.15.   c. Annex, point (2), (j) Item D4 on "Protection of the vehicle against cyber attacks" applies 
to STU (Separate Technical Unit) and component. The European Commission adopts UN Regulation 
No 155 as the implementation regulation of this requi rement, and plans to implement on Class M, 
Class N models, and STU from 6 July 2022. However, UN Regulation No 155 only applies to vehicle 
type approval, and STU cannot obtain type approval under this regulation. China proposes that 
Annex, point (2), (j) I temD4 not apply to STU. d. Annex, point(2), (n) Item E4 on "Driver availability 
monitoring system", (o) E6 on "Systems to replace driver's control", E7 on "Systems to provide the 
vehicle with information on the state of the vehicle and surrounding area " will adopt UN Regulation 
No 157 as the type approval regulation for these projects. UN Regulation No 157 is a type approval 
regulation for ALKS systems, but it is unclear which parts of UN R157 Item E4/E6/E7 should comply 
with, leading to misunderstanding. C hina proposes the EU to further clarify which sections of UN 
Regulation No 157 should be implemented. Meanwhile, if multiple Items adopt the same type of 
approval regulations, please further explain the conformity assessment procedures of separate type 
approval certificates for these items.  
2.16.   In response, the delegation of the European Union  provided the following statement. The 
European Union would like to thank the People's Republic of China for the comments on notification 
G/TBT/N/EU/882 , sent on 13 May 2022. The EU regrets that Chin a did not make its statement on 
this trade concern available in time, and therefore cannot answer the concerns contained therein. 
However, the EU may provide some elements to answer China's concerns as presented in official 
TBT comments. The EU will respec t its obligations in accordance of UN Regulations and will not 
mandate the latest amendments of UN regulations before the agreed transitional provisions set out 
 
7 For previous statements follow the thread under ID 752 . G/TBT/M/87  
 
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  in these amendments. The table in Annex II to Regulation 2144/2019 only lists which UN Regulati ons 
shall apply for a specific topic without mandating a specific version of the concerned regulations.  
2.17.   Annex I to Regulation 2144/2019 lists the UN Regulations that apply on a compulsory basis 
and refers to the latest versions of UN Regulations published in the EU official journal. This is without 
prejudice to the transitional provisions included in the UN regulations. As a standard, the EU applies 
on a mandatory basis the transitional provisions set out in the amendments to UN regulations, unless 
the topi c in Regulation 2144/2019 applies from a later date. This is reflected in the notes inserted 
after the table in Annex I. As an example, the highest requirements for advanced emergency braking 
systems (AEBS) for pedestrians and cyclists will apply from 1 Ma y 2024 for new vehicle types of 
vehicles in UN Regulation 152, but AEBS for pedestrians and cyclists will be required in the EU for 
new vehicle types only from 1 July 2024 (i.e. at later date). The EU currently finalizes the analysis 
of China's comments an d will shortly provide an official reply through the Enquiry Point.  
2.1.2.5   Canada - Proposed Prohibition of Certain Toxic Substances Regulations, 2022, 
G/TBT/N/CAN/673  (ID 7538) 
2.18.   The delegation of Japan  provided the following statement. Japan shares the following concerns 
regarding the pr oposed DBDPE restrictions in the Proposed Prohibition of Certain Toxic Substances 
Regulations, 2022. DBDPE is widely used in electrical and electronic equipment, automobiles, 
aircraft, medical equipment, industrial equipment, social infrastructure equipmen t, agricultural 
machinery, industrial machinery, construction machinery and industrial vehicles. DBDPE is an 
alternative to decaBDE, a globally banned brominated flame retardant, and is not restricted by 
international conventions or other jurisdictions. In  addition, since there is no equivalent flame 
retardant for many applications that can be used as a substitute for DBDPE currently, we are 
concerned that there will likely be significant and serious impacts on the trade and distribution of 
the above equipm ent in case that the use of DBDPE is prohibited. In particular, medical equipment, 
industrial equipment, social infrastructure equipment, agricultural machinery, industrial machinery, 
construction machinery and industrial vehicles are important instruments  that support those 
industries and the citizens' lives in Canada. We understand that the Canadian government seems to 
be considering the introduction of the regulations carefully. However, Canada should be particularly 
cautious about considering alternativ es to DBDPE including safety assessments and establishing a 
grace period for implementation, with additional hearings from stakeholders. It should also be noted 
that the risk of exposure to humans and the environment is limited because these devices are 
collected under strict control after use and properly recycled or disposed of.  
2.19.   Canada cited the protection of endangered whales and belugas as the main reason for 
regulating DBDPE. Although we understand the objectives of policy, Japanese industry reports th at 
DBDPE contained in articles poses a very low risk of adverse effects on humans and the environment, 
including these endangered species. Therefore, in order to ensure that the proposed DBDPE 
restriction is not more trade restrictive than necessary to ach ieve its legitimate objectives, Japan 
would like to request that more thorough risk assessment regarding humans and the environment 
should be conducted on the effects of DBDPE contained in articles, while taking into account the 
consistency with results of  risk assessment from other countries and regions, and that a realistic 
feasibility study should be conducted on the alternatives.  
2.20.   In response, the delegation of Canada  provided the following statement. Canada notified the 
Proposed Prohibition of Certain T oxic Substances Regulations, 2022 (G/TBT/N/CAN/673 ) to the WTO 
TBT Committee on 18 May 2022, providing Members the opportunity to review the measure and 
share comments by 28 July 2022. While we note Japan's intervention, and the fact that this is the 
first opportunity we have to he ar Japan's concern with the proposed rule, Canada would encourage 
Japan to share its comments in writing via Canada's Enquiry Point before the 28 July deadline. 
Canada is also open to engage bilaterally with Japan to discuss its views and concerns over the  
measure.  
 
8 For previous statements follow the thread under ID 753 . G/TBT/M/87  
 
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  2.1.2.6   South Africa - Regulations Relating to the Labelling of Alcoholic Beverages - 
revision, G/TBT/N/ZAF/48/Rev.2/Add.1  (ID 7549) 
2.21.   The delegation of the European Union  provided the following statement. The EU thanks South 
Africa for notifying their propos ed revisions to their alcohol beverage composition, production, and 
labelling regulations on 12 December 2021. The EU sent written comments on 16 February 2022. 
Our key concerns relate to the following South African categories: spirit aperitif, gin, descri ption of 
pot still brandy and vintage brandy. The category of "spirit aperitif" with its minimum and maximum 
alcoholic strength together with the existing minimum alcohol limits set for other "defined classes in 
South Africa (example whiskey) could result in a number of EU spirit drinks no longer having the 
right to be marketed in South Africa. We suggested that South Africa creates a new category "spirit 
drink" for products that do not fall under South Africa categories due to their alcohol content. Withou t 
the flexibility that a "spirits drink " category could offer, many EU products will no longer be 
exportable to South Africa, due to the proposed changes. We would be grateful if South Africa could 
take these concerns into account. We would also welcome a precise indication of the likely timelines 
for adoption of the revision.  
2.22.   The delegation of the United States  provided the following statement. The United States would 
again like to encourage South Africa to consider our concerns regarding classification of  flavoured 
spirit products. It is our understanding that South Africa's spirit aperitif category includes a 30% 
maximum alcohol by volume (abv) requirement. Further, South Africa's specific category for 
flavoured whiskey includes a 43% minimum abv requirem ent. In the United States, some whiskeys 
are produced with an abv greater than 30% but less than 43%. The United States is concerned that 
this measure may unnecessarily restrict imports of US flavoured spirits that fall between the alcohol 
content requirem ents of the spirit aperitif category and other specific categories. Can South Africa 
please confirm what the appropriate classification would be for such products? In its response to the 
U.S. Government's comments, South Africa indicated that the 43% minim um abv requirement for 
whiskey was a long -standing requirement. Would South Africa consider raising the maximum abv 
requirement for the spirit aperitif category instead to account for flavoured spirit products containing 
greater than 30% abv, but less than  43% abv? We thank South Africa for considering our comments 
and concerns and look forward to continued engagement with South Africa to address these concerns 
and ensure trade of US flavoured spirits is not unnecessarily disrupted.  
2.23.   The delegation of Mexico  provided the following statement. With regard to this specific trade 
concern, we are of the understanding that it is a concern about the same measure that was included 
in the previous meeting of the Committee and that now also features as Specific Trade C oncern 
No. 80. Despite this duplication, in order to ensure the traceability of concerns, we will be making 
statements under both items to keep them separate.  The delegation of Mexico refers to its statement 
made at the previous meeting of this Committee in March 2022 on the Regulations relating to the 
composition, production and labelling of wine and spirits intended for sale in the Republic of South 
Africa, no tified to the Members of the Committee on 20  December  2021 in document 
G/TBT/N/ZAF/48/Rev.2/Add.1 . Firstly, we thank the Government of South Africa for responding to 
the comments sent during the public consultation period, in which both the Mexican industry an d 
Government participated to share observations on what we consider could have an impact on 
Mexican exporters of tequila and mezcal, as well as on potential exporters of raicilla and bacanora.  
However, the delegation of Mexico wishes to point out that thes e concerns remain, since South 
Africa's response to the comments sent by the Government of Mexico do not address each of the 
remarks made in Official Circular No. 500/RVL/044/2022 of 11 February 2022.  
2.24.   In this regard, we appeal to the good offices of the de legation of South Africa to address the 
following comments relating to concerns stemming from the lack of inclusion in the Regulations of 
clear definitions for beverages of Mexican origin:  We ask that, separate from the "100% agave" 
class, there be a clear  specific class for tequila that complies with the applicable Mexican regulations, 
taking into account that tequila has been registered as a certification mark in South Africa since 
2004.  In order to avoid potential confusion among consumers, we ask that n o reference be made in 
the "100% agave" class to tequila or its classes or categories, even in Spanish.  We also highlight 
the request for uniform definitions for Mexico's emblematic beverages, such as mezcal, bacanora 
and raicilla, which have their own ori gin, physico -chemical specifications and identity characteristics, 
as established in the respective Mexican Official Standards.  In addition, and with the aim of following 
up on our concerns in a timely manner, we would be grateful if the delegation of Sout h Africa would 
 
9 For previous statements follow the thread under ID 754 . G/TBT/M/87  
 
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  provide us with a contact point through which we could regularly follow up on the development of 
the Regulations . The delegation of Mexico thanks the delegation of South Africa for giving its 
consideration to this statement.  
2.25.   In response, the  delegation of South Africa  provided the following statement. We thank the 
EU and the US for the interest they have shown in the notification submitted by South Africa and 
the comments that Mexico has previously submitted on the regulations relating to the  labelling of 
alcoholic beverages in document G/TBT/N/ZAF/48/Rev.2/Add.1 . We acknowledge that there has 
been communication between the EU and South Africa and between the US and South Africa. This 
communication has not resolved the issues but new questions pos ed and more issues to be clarified. 
We have provided a detailed response to this. We believe that addressing the issues in a consultation 
with relevant Members with a view to resolving them instead of statements presented to the TBT 
Committee will provide much needed clarification and specific responses to questions raised. We are 
ready to engage constructively to resolve all the concerns and all comments that the EU, the US and 
Mexico have raised. Our South African Permanent Mission in Geneva could be cont acted to facilitate 
such engagement and we hope that we can report in the next meeting that the STC has been 
resolved amicably.  
2.1.2.7   United States - Energy conservation program: energy conservation standards for 
room air conditioners, G/TBT/N/USA/305/Rev.1  (ID 75510) 
2.26.   The delegation of China  provided the following statement. The calculation method of energy 
efficiency testing in this regulation is dif ferent from international standards. a) There are two CEER 
test methods for RAC products, for fixed frequency air conditioners and frequency conversion air 
conditioners. It is unreasonable for two calculation methods targeted to one index (CEER), nor can 
these methods reflect the real gap between fixed frequency and frequency conversion products. 
Therefore China suggests that the US unify the testing methods of unified fixed frequency and 
frequency conversion products when upgrading the energy efficiency. b) Seasonal energy efficiency 
can evaluate products' comprehensive performance. The EU and other Members such as Japan, 
South Korea, and Australia all adopt seasonal energy efficiency. At present, many Members have 
changed to use seasonal energy efficiency evaluation when upgrading their energy standards. 
However, the RAC product energy efficiency proposal in the US still uses a single point of energy 
efficiency index CEER for product evaluation, which is different from the international standards.  
2.27.   Therefore , China suggests the US use the energy efficiency test method consistent with the 
international standard ISO 16358. The CEER index value in this proposal increases, compared with 
the current DOE energy consumption regulations and the Energy Star index, and  the CEER energy -
saving index of room air conditioning greatly increases. The excessive increase of the index will 
result in a significant increase in the cost of design, manufacturing and logistics for export 
enterprises. China proposes the US gradually i ncrease the index based on the average increase of 
index in the previous energy efficiency standards to ensure the healthy development of the industry.  
2.28.   In response, the delegation of the United States  provided the following statement. The United 
States app reciates the comments submitted by China on 2 June 2022. The United States will take 
into consideration all comments received during the open comment period and respond to each 
substantive comment in the next published rulemaking procedure on standards for  room air 
conditioners.  
2.1.2.8   France - Order specifying the substances contained in mineral oils the use of 
which is prohibited in packaging and in printed matter distributed to the public, 
G/TBT/N/FRA/216  (ID 75611) 
2.29.   The delegation of the Republic of Korea  provided the following statemen t. The Korean 
government appreciates this opportunity to provide its comments on the final text of the "Order 
Specifying Substances Contained in Mineral Oils Prohibited for Use on Packaging and Printing 
Materials Distributed to the Public", which was publi shed on 3 May 2022. Korea fully respects and 
strongly supports France's efforts to introduce a regulation banning the use of mineral oils on the 
packaging and printed matter with the aim to improve the recycling of waste and protect public 
health. However,  because we have not yet received any replies from the relevant competent 
 
10 For previous statements follow the thread under ID 755 . 
11 For previous statements follow the thread under ID 756 . G/TBT/M/87  
 
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  authorities of France regarding our comments submitted through the French Enquiry Point on 
29 March and 6 May 2022 twice, Korea would like to deliver the following concerns.  
2.30.   First, w e would like to request that France clarify the application scope of the regulation. It is 
difficult to identify the regulated substances with only the reference of MOAH (1 to 7 aromatic rings) 
and MOSH (C16 to C35 carbon atoms) in Article 2 of the publish ed Order. Therefore, more specific 
substance information, such as CAS Numbers., etc, needs to be provided. In addition, we would like 
to request that France confirm whether the target of the ban is the content of mineral oil in ink or 
the residual amount o f mineral oil in printed materials. If the regulation targets the residual amount 
in printed and packaging materials, rather than in ink, banned substances may be detected 
unintentionally during the conformity assessment process, so we seek a clear confirm ation in this 
regard. Also, we request that France confirm whether the sticker labels attached to products or 
packaging fall under the scope of regulation. Second, we request information regarding the type of 
conformity assessment (whether it is Certificat e of Conformity or Declaration of Conformity), the 
detailed test methods and the list of laboratories to use for conformity assessment.  
2.31.   If the regulation requires DoC (Declaration of Conformity), could France confirm the entity 
responsible for issuing the declaration and provide a verification guideline that finished product 
manufacturers may use? France is the only country that restricts MOAH and MOSH in packaging 
materials for non -food products. Therefore, in the event of ink manufacturers in other countr ies not 
issuing a declaration, finished product companies will need guidance to perform verification. Lastly, 
in the final text of the Order, it is stated that the regulation will be enforced from 1 January 2023, 
and a regulated item's compliance deadline depends on its date of manufacture or import. We 
request that France clarify which date the suppliers should reference for compliance in case of a 
discrepancy between the date of manufacture and the date of import. In addition, we request a 
confirmation wh ether France will allow the distribution in commerce for products with the existing 
packaging materials until 31 December 2023, which is the deadline for the disposal of the remaining 
stocks.  
2.32.   The delegation of the United States  provided the following state ment. The United States 
appreciates France's 3 February 2022, notification of this Order to the WTO and thanks France for 
acknowledging receipt of our corresponding comments on 6 April 2022. While we support France's 
objective of combating waste and limiti ng the use of non -recyclable materials, we have questions 
regarding the specifics of the draft regulation. We are concerned about the proliferation of divergent 
packaging, labelling, and recycling laws within the EU and its member States. We encourage Fran ce 
to ensure that such regulations do not have the effect of creating unnecessary obstacles to 
international trade. We are concerned that this Order will create an undue burden for companies 
selling products in France. As outlined in our comments sent to F rance's Enquiry Point, we continue 
to seek clarity on the scope, timeline, and objectives of this Order. Could France please provide an 
update on when we can expect to receive responses to our 6 April comments? We have heard 
concerns from some manufacturer s and exporters of packaging and printed matter, including that 
made from recycled materials, that they will not be able to adapt their products or methods of 
production to comply with the order before the implementation date of 1 January 2023. We request 
that France take into account stakeholder comments regarding their ability to meet the proposed 
timeline and adjust implementation dates to ensure a reasonable transition period as required under 
the WTO TBT Agreement.  
2.33.   In response, the delegation of the European Union  provided the following statement. Thank 
you to the delegations of Korea and the United States for their interest in the "Order specifying the 
substances contained in mineral oils the use of which is prohibited in packaging and in printed matte r 
distributed to the public", notified by France to the WTO under reference G/TBT/N/FRA/216 . France 
received Korea's comments on this TBT notification. A reply is currently under preparation and it will 
be sent to Korea via the European Union TBT Enquiry Point. As regards the clari fication of the scope 
of the regulation and the identification of substances of concern, the Order reflects the French Agency 
for Food, Environmental and Occupational Health and Safety opinion (ANSES) which does not allow 
a simple designation by CAS Number s or such identification. As regards the target of the ban, Article 
1 of the Order clearly states that it is the content of mineral oil in ink that has to be considered. 
Nevertheless, in order to give some flexibility to demonstrate compliance, the assessm ent might be 
possible after printing (in particular due to the volatility of certain substances).  
2.34.   Further to this, the French Order does not prescribe specific test methods to demonstrate 
conformity. According to article R.543 -49 of the Environmental Code,  the demonstration should be G/TBT/M/87  
 
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  based on the production of written or technical documents. A working group will be set up in order 
to identify, with stakeholders, solutions available, difficulties and needs by the 2025 deadline. 
Appropriate solutions to demon strate compliance could be discussed as well. Regarding the 
Declaration of Conformity, the entity in charge of controlling the conformity is the department in 
charge of consumer affairs, competition and the repression of fraud (DGCCRF). So far no guideline s 
on performing verification have been set up. We would like to clarify that the date that has to be 
considered for a packaged imported product to be placed on the market in France is the date of 
import, not the date of manufacturing. Therefore, if the pac kaging was manufactured before 
1 January 2023 – the entry into force of the Order - but the product itself or its packaging is imported 
to France after that date, the ban will apply.  
2.1.2.9   India - Alert Regarding Implementation of QR Code for Refrigerators (ID 7 5712) 
2.35.   The delegation of the Republic of Korea  provided the following statement. Korea respects the 
efforts of the Indian government to protect the consumers. Furthermore, Korean companies are 
endeavouring to comply with the regulation of India. However, Ko rea would like to deliver Korean 
companies' concerns as there are difficulties in the industry regarding the "Implementation of QR 
Code for Refrigerators" announced on 31 March 2022 without any notification according to the WTO 
TBT Agreement. First of all,  according to the document published on 31 March 2022 by BEE (Bureau 
of Energy Efficiency) of India, the requirement to affix a QR Code below the BEE Star Label on each 
unit of refrigerator will be enforced mandatory from 1 January 2023. However, this meas ure is 
against Article 2.9.2 of the WTO TBT Agreement to "notify other Members through the Secretariat 
of the products to be covered by the proposed technical regulation", and Article 2.9.4 of the 
Agreement to "allow reasonable time for other Members to ma ke comments in writing". Therefore, 
Korea requests that India provide Members with time to make comments in accordance with the 
TBT Agreement.  
2.36.   As the regulation is scheduled to be enforced without any WTO notification process and period 
for comments from M embers, it would be difficult for manufacturers to meet the regulatory 
requirements by the proposed date of enforcement. Korean companies claim that they need at least 
12 months in order to comply with the new regulation. Therefore, Korea requests that Ind ia carry 
out the due notification and comment processes, and then provide a transition period of 12 months 
from the publication date of the final text of the regulation, so that companies can adapt their 
production facilities for QR Code labelling. Additio nally, unlike other countries such as the EU, United 
Kingdom, Türkiye, China, and Saudi Arabia, which require QR Codes assigned to each model name, 
India runs a different system that requires QR Codes assigned to each serial number of the product. 
As such,  the regulation is excessive that the Korean companies have difficulties complying. 
Therefore, Korea requests that India improve the regulation in a way that the QR Code labels are to 
be generated by the model name rather than by the serial number of the r efrigerator.  
2.37.   In response, the delegation of India provided the following statement. The energy 
performance benchmarks (star rating levels) under Standards & Labelling (S&L) programme are 
implemented by Bureau of Energy Efficiency (BEE) in accordance with S ection 14 of the Energy 
Conservation Act, passed by the Parliament of India. The regulatory mechanism of the S&L 
programme encompasses a provision of Monitoring and Verification, under which, BEE has proposed 
to implement the secure QR code along with star  label on the appliance/equipment in order to enable 
authenticate/validate the star rating specifications of the label by the consumer himself. The 
discussion for implementation of QR Code on refrigerators was initiated during the year 2019. In 
this regard  the first meeting of stakeholders including manufacturers of product from various 
countries including Korea was held on 5 November 2019 wherein, workflow and the effective 
timelines for 1 March 2020 was announced and circulated to the stakeholders includi ng the Korean 
manufacturers registered with BEE under S&L programme. However, the implementation timeline of 
the QR code got delayed due to the COVID -19 pandemic situation. Further, during the year 2021, 
the new timelines of 1 January 2023 was communicated  to all the stakeholders through virtual 
meetings. Various comments and inputs received from the manufacturers on the workflow of QR 
code were addressed by BEE from time to time.  
2.38.   Subsequently, BEE had issued a formal alert during March 2022 on the mandator y timeline 
for Implementation of QR code with effect from January 2023. This alert was issued based on the 
request received from manufacturers to issue a formal announcement before eight to  nine months 
 
12 For previous statements follow the thread under ID 757 . G/TBT/M/87  
 
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  from the date of issue of the Gazette notification. T he energy performance benchmarks (star rating 
levels) under Standards & Labeling (S&L) programme are implemented by Bureau of Energy 
Efficiency (BEE) in accordance with Section 14 of the Energy Conservation Act, which is passed by 
the Parliament of India. As such, no formal notification through other platform is required for 
implementation of the QR code under S&L program. Further, it may please be noted that, few 
manufacturers have successfully completed the pilot run in the month of May 2022. The objectiv e 
of implementation of QR code is to authenticate / validate the star rating specifications of the label 
to protect the interest of consumers. It may be noted that, generation of QR code by model name 
rather than by serial number of each unit of refrigerat or may defeat BEE's purpose of validating the 
credibility of star label affixed on each unit / product of refrigerator being purchased by the 
consumer.  
2.1.2.10   France - Decree on the minimum proportion of re -used packaging to be placed 
on the market annually, G/TBT/N/FRA/223  (ID 75813) 
2.39.   The delegation of the United States  provided the following statement. The United States 
appreciates France's 3 March 2022, notification of this Decree to the WTO and thanks France for 
acknowledging receipt of our corresponding comments on 28 April 2022. While we support France's 
objective o f increasing the availability of reusable packaging and reducing the amount of pollution 
caused by packaging waste in the environment, we continue to have questions about the proposed 
path outlined in the draft regulation. Regarding this particular measure , we note that France provided 
a 60-day comment period with an adoption date of 31 days after the notification's distribution. How 
did France take all stakeholder comments received within the comment period into account if the 
adoption date occurred before  the end of the comment period? Can France confirm that the Decree 
was adopted on 3 April 2022, as was stated in the notification? Can France provide an update on the 
proposed date of implementation? We ask that France continue to work with its trading par tners to 
fully assess impacts to trade resulting from the implementation of this measure. We encourage 
France to respond to our questions submitted to France's TBT Enquiry Point and ensure the views of 
WTO Members are fully considered before implementing t he measure.  
2.40.   The delegation of Argentina  provided the following statement. We note that the measure was 
notified in document G/TBT/N/FRA/223  in March this year. The Decree establishes the obligation to 
recycle a certain percentage of containers and packaging, increasing over time, i n order to reduce 
waste and move towards a circular economy. Accordingly, it establishes deadlines and procedures 
for those within the supply chain to organize themselves to comply with this obligation. The definition 
of producer includes importers, which is why, although this is not specified, the Decree could affect 
wines exported to France. Argentina is therefore concerned about this measure and wishes to consult 
France on the scope of this Decree in relation to imported products, how it intends to apply  it to 
imported products and whether this does not amount to an extraterritorial application of a provision 
that aims to reduce waste and recycle in order to protect the environment.  
2.41.   In response, the delegation of the European Union  provided the following  statement. The EU 
would like to thank the delegation of the United States for its interest in the "Decree on the minimum 
proportion of re -used packaging to be placed on the market annually", notified by France to the WTO 
under reference G/TBT/N/FRA/223 . The EU can confirm that thi s decree was published in the French 
Journal official in April 2022. The draft decree was amended during its examination by the Council 
of State, especially to take into account some difficulties raised by the representatives of the United 
States or raised  by Producers Responsibility Organisation, to facilitate their compliance with the 
provisions of the decree. Increasing the re -use of packaging is crucial to achieve the phasing out of 
all single -use plastic packaging by 2040, as prescribed by the French a nti-waste law of February 
2020. Therefore, a dedicated structure, the Re -use Observatory, hosted by the Ecological Transition 
Agency, has been set up to ensure the collection and dissemination of information and studies related 
to the re -use. The Observato ry might conduct any study necessary to assess the relevance of re -
use and recycling solutions from an environmental and economic perspective. It might support, in 
conjunction with Producers Responsibility Organisation, the implementation of experiments an d will 
ensure the coordination of the stakeholders concerned by re -use. 
 
13 For previous statements follow the thread under ID 758 . G/TBT/M/87  
 
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  2.1.2.11   Viet Nam - Draft national technical regulation on 5G user equipment - radio 
access; draft national technical regulation on non -standalone 5G user equipment - radio 
access, G/TBT/N/VNM/188 , G/TBT/N/VNM/202  (ID 75914) 
2.42.   The delegation of China provided the following statement. Viet Nam Regulations QCVN 
127:2021/BTTTT and QCVN 129:2021/BTTTT require that starting from 1 July 2022, all certificates 
obtained in accordance with the old 5G regulations must be updated in accordance with the new 
technical regulations to ensure a smooth import process. Viet Nam has released a list of laboratories 
for the new 5G Regulations, and as it is clearly shown that these laboratories are all located in 
Members that have signed bilateral accreditation agreement s with Viet Nam. Since China and 
Viet Nam are signatories to a multilateral recognition agreement for ILAC testing agencies, China 
proposes Viet Nam accept the CE/FCC 5G report from relevant Chinese laboratories and clarify the 
certification operation mode  on 5G products that are certified but do not meet the technical 
requirements of the new 5G Regulations.  
2.43.   In response, the delegation of Viet Nam  provided the following statement. Viet Nam thanks 
China for the interest in the drafts of national technical regulations on 5G user equipment and non -
standalone 5G equipment - radio access. These drafts of national technical regulations were notified 
to WT O Members in notifications G/TBT/N/VNM/188  and G/TBT /N/VNM/202  in 2021 with a comment 
period of 60 days from the date of notification. During the comment period, Viet Nam received 
comments from WTO Members, including China, these comments have been reviewed and taken 
into consideration in the final measures  as QCVN 127:2021/BTTTT and QCVN 129:2021/BTTTT. On 
17 June 2022, Viet Nam issued Document No. 2361/BTTTT -KHCN guiding the application and 
facilitation of testing under QCVN 127:2021/BTTTT and QCVN 129:2021/BTTTT, which accepted test 
results of foreign tes ting laboratories accredited to ISO/IEC 17025, or of the manufacturers, 
according to international standards equivalent to 3GPP/ETSI to certify 5G equipment. The 
respective Chinese laboratories can apply the guideline document 2361/BTTTT -KHCN and accept th e 
test results. From 1 July 2022, all 5G devices imported into Viet Nam must be tested according to 
QCVNs or equivalent international standards as mentioned in the guiding document and submit a 
dossier to the Certification bodies appointed by the Ministry of Information and Communications to 
be granted a certificate of conformity.  
2.1.2.12   India - Amendment to notification on mandatory testing and certification of 
telecommunication systems (MTCTE) – Phase III & IV, G/TBT/N/IND/229  (ID 76015) 
2.44.   The delegation of China  provided the following sta tement. Article 5 "Only test results/reports 
issued by labs accredited by ILAC signatories from none -border sharing countries will be accepted " 
does not conform with Articles 2.1, 2.2, 5.1.2, and 6.1.1 of the WTO/TBT AgreementChina proposes 
India amend art icle 5 of "Amendment to Notification on Mandatory Testing and Certification of 
Telecommunication Systems (MTCTE) - Phase III&IV" to accept test results from all laboratories 
approved by the International Organization for Laboratory Accreditation Cooperatio n (ILAC) 
signatories.  
2.45.   In response, the delegation of India provided the following statement. Testing and 
Certification requirements under Mandatory Testing and Certification of Telecommunication Systems 
(MTCTE) scheme were notified through Indian Telegraph  (Amendment) Rules, 2017 (WTO TBT 
Notification G/TBT/N/IND/66 . MTCTE Scheme is being launched in a phased manner and telecom 
products are gradually being brought under MTCTE regime. This is an amendment to the notification 
issued for MTCTE Phase III & IV published vide G/TBT/N/IND/218  on 15 November 2021 and 
amendment vide G/TBT/N/IND /229 dated 17 March 2022.  
2.1.2.13   China - Recommended National Standard (GB/T) for Office Devices (Information 
security technology – Security specification for office devices) (ID 76116) 
2.46.   The delegation of Japan  provided the following statement. Japan has concerns with regard to 
the amendment of the Chinese Recommended National Standard (GB/T) for office devices like 
multifunction peripherals and printers. Japan is currently in contact with the information that d raft 
amendment to the Chinese Recommended National Standard (GB/T) for office devices such as 
 
14 For previous statements follow the thread under ID 759 . 
15 For previous statement s follow the thread under ID 760 . 
16 For previous statements follow the thread under ID 761. G/TBT/M/87  
 
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  multifunction peripherals and printers is being considered in China. Japan has heard that, regarding 
to office devices including multifunction peripherals and pri nters procured by the Critical  information 
infrastructure operators etc., the draft amendment of the national standard requires as follows: 
(i) Office devices such as multifunction peripherals and printers including their components are 
required to be deve loped, designed and produced in China; (ii) the information to prove that office 
devices and/or their components are developed, designed and produced in China is required to be 
disclosed.  
2.47.   If the national standard including such requirements is introduced, considering that the 
application of this national standard is recommended by a government, this national standard is 
highly likely to be generally adopted. There is a concern that the national standard will be practically 
enforced as mandatory. In such cas e, imports of finished products such as multifunction peripherals 
and printers will not be permitted. Also, the use of imported components will not be permitted, and 
the use of the components made in China will be forced. Thus, it will be inevitable that f oreign 
products including Japanese imports will be treated discriminatorily against domestic products. This 
would be inconsistent with Article 2.1 and Article 2.2 of the TBT Agreement and Article 3.4 of the 
GATT. By the actual operation of the national sta ndard, for example, Japan concerns that this 
national standard will effectively force technology transfer when foreign producers have no choice 
but to provide their technology to China for production in China. This would be inconsistent with 
Article 7.3 of  the WTO protocol on the accession of China. Just in case Japan notes that, although 
certain obligations do not apply to standards for government -procured products under Article 1.4 of 
the TBT Agreement and Article 3.8 (a) of the GATT, Japan has heard that  the description of the 
scope of the amendment to the national standard is not limited to government -procured products 
therefore Japan recognizes that it cannot be justified by the government -procured exceptions under 
the TBT Agreement and the GATT. Japan strongly hopes that the amendment of this national 
standard, and any systems and/or guidelines related to this national standard, which include content 
that discriminates foreign products or producers against domestic ones and forces technology 
transfer, w ill not be realized. Japan also recalls that China is obliged to notify the proposed measures, 
which would be effectively mandatory, to the WTO in advance in accordance with the obligations of 
Article 2.9.2 of the TBT Agreement.  
2.48.   The delegation of the Europ ean Union  provided the following statement. The EU would like to 
support this STC, also noting that we do not agree with localization requirements in standards, and 
requests that China provide information on this measure, preferably in English, and notify to the 
WTO, where applicable.  
2.49.   In response, the delegation of China  provided the following statement. This is a new concern 
and this is the first time the concern has been added. China takes note of your concerns and will 
provide a reply at a later date.  
2.1.3   Previously raised concerns  
2.1.3.1   China - Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29417) 
2.50.   The delegation of the European Union  provided the following statement. Regarding the Multi -
Level Protection Scheme (MLPS), the EU would like to refer to its comments raised at previous TBT 
Committee meetings,  namely concerns around (i) the lack of clarity in certain definitions, and (ii) 
the unwarranted and significant market entry restrictions, including by demanding that all networks 
above Level 3 be subject to the legal obligations that were originally dest ined for Critical Information 
Infrastructure (CII). The EU calls for enhanced proportionality and transparency in the 
implementation of the Cyber -MLPS.  
2.51.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding Chi na's Regulation on Commercial Encryption Products and Cybersecurity Multi -Level 
Protection Scheme. Japan would like to refer to the previous statement we made at the last TBT 
Committee in March 2022. Japan would like to continue to request that China provi de relevant 
information regarding the current revision process of the Regulation on Commercial Encryption 
 
17 For previous statements follow the thread under ID 294 . G/TBT/M/87  
 
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  Products that was subject to public consultation up to 19 September 2020, and the current drafting 
process of the Cybersecurity Multi -Level Protection  Scheme that China described at the last TBT 
committee, and that those regulations are to be implemented transparently.  
2.52.   In response, the delegation 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, and 
established a unified national certification scheme for commercial cryptography. The management 
of commercial e ncryption products fully reflects the principles of non -discrimination and fair 
competition. It treats domestic and foreign products and companies equally. China implements 
mandatory testing and certification on commercial encryption products that involve national security, 
national economy, people's livelihood, and public interest, and implements voluntary testing and 
certification on other commercial encryption products. Regarding the MLPS, with technology 
development, in response to more complicated cybersecurity  circumstances, an information security 
multi-level protection scheme needs to be improved. Based on experience in past years and 
responding to new development, Cyber -security Law stipulates that China will carry out the cyber -
security MLPS, which  is based on information security MLPS. To fulfill the requirements in Cyber -
security Law, regulations on cyber -security MLPS are under drafting, which was published for 
comments in June 2018 and will replace the former administrative measures on informati on security 
MLPS.  
2.1.3.2   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 indic ations, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EEC/264 , G/TBT/N/EEC/264/Add.1 , G/TBT/N/EU/44 , G/TBT/N/EU/570 , 
G/TBT/N/EU/571  (ID 34518) 
2.53.   The delegation of the United States  provided the following statement. This is the longest 
continuously -raised STC in the history of the TBT Committee. The United States has raised concerns 
on lack o f transparency and market access for wine for well over a decade. Despite asking for 
updates on the US applications for the use of traditional terms for wine exports to the EU both in 
this forum and bilaterally, our exporters have no expectations that thei r pending applications will 
ever be processed as our requests do not result in substantive responses. The EU's traditional terms 
for wine regime restricts exporters' use of the following terms unless specifically granted the right 
to use those terms by the  EU: chateau, classic, clos, cream, crusted/crusting, fine, late bottled 
vintage, noble, ruby, superior, sur lie, tawny, vintage, and vintage character. While we do not agree 
that the EU should claim exclusive use of these common terms, our exporters nonet heless sought 
to comply with the regime. To date, the EU has only approved two (classic and cream) of the 13 
applications we submitted in June 2010, and has yet to act on our applications for the 11 remaining 
terms.  
2.54.   It is incredibly disappointing that this  issue has not been resolved with one of our major 
trading partners. The persistent lack of meaningful dialogue towards a resolution leaves us to believe 
that the EU never intended to act on the pending applications in good faith. It is clear that raising 
this issue in this forum has not been successful. Thus, this is the last time that the United States 
intends to raise this issue at the TBT Committee. Understanding the EU's process and timeline for 
review of our industry's pending applications for use of traditional wine terms remains a priority for 
the United States. We will continue to engage the EU outside of the TBT Committee on these 
concerns.  
2.55.   The delegation of New Zealand  provided the following statement. We refer the European Union 
to New Zealand's statement on this trade concern made at the March 2022 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 Organiz ation. 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 c ountries who wish to use traditional terms in the European 
Union.  
 
18 For previous statements follow the thread under ID 345 . G/TBT/M/87  
 
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  2.56.   The delegation of Argentina  provided the following statement. We thank the United States for 
including this specific trade concern (STC) on the Committee's agenda. Argentina reiterates conce rns 
expressed at previous meetings of this Committee regarding the discrimination suffered by national 
wines, which are prevented from using the traditional terms "Reserva" and "Gran Reserva" on their 
labels, even though our country completed the substanti ve procedure to approve such terms in 
March 2012 under EU Law. We once again urge the EU to activate all applications for the registration 
of traditional terms submitted by third countries such as Argentina, which have come to a standstill 
without any lega l justification, thereby constituting a technical barrier to trade.  
2.57.   In response, the delegation of the European Union  provided the following statement. The EU 
understands the continued interest of the United States and other Members in this issue. The EU 
believes that its internal legislation offers a meaningful and transparent system of protection to 
traditional terms used on wine products from the EU, as well as on products from third countries. 
The EU has demonstrated its ability to address specific Memb ers' concerns in this area either via its 
internal legislation or via bilateral agreements. The EU treats applications to protect traditional terms 
from both member States and third countries as is foreseen under Regulation 1308/201319 
establishing a commo n organization of the markets in agricultural products (the "CMO Regulation "). 
Such applications for traditional terms are rather limited. The CMO  Regulation does not set a deadline 
for approval or rejection. As to the specific questions by Members in previous TBT Committees, the 
EU refers to Commission Delegated Regulation (EU) 2019/3320 on the applications for protection of 
designations of origin,  geographical indications and traditional terms in the wine sector, and, in 
particular, to Article 50 in conjunction with Annex IV part B, which contains the list of wine grape 
varieties and their synonyms that may appear on the labelling of wines, also fo r imported wines. A 
definition of "generic" can be found in Article 27(3) of Commission Delegated Regulation 2019/33. 
On the barrel -aged indication, the EU refers to Annex V of this Regulation.  
2.1.3.3   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 , 
G/TBT/N/IDN/134 , G/TBT/N/IDN/139 , G/TBT/N/IDN/140  (ID 50221) 
2.58.   The delegation of the European Union  provided the following statement. The European Union 
reiterates its serious concerns on the Indonesian Halal Product Guarantee Law No 33 of September 
2014 a nd its implementing provisions, which require mandatory halal certification and labelling for 
a very wide range of products to be placed on the Indonesian market, resulting in significant 
obstacles to EU trade with Indonesia. The EU regrets that, contrary to Article 2.9 of the WTO TBT 
Agreement, Indonesia failed to notify to the TBT Committee the Halal Product Guarantee Law. As 
regards recent implementing provisions, the EU regrets that, on 6 January 2022, Indonesia adopted 
Regulation N° 2/2022 on Internati onal Cooperation on Halal product assurance (G/TBT/N/IDN/139 ), 
which entered into force that same day, before the expiration of the 60 -day commenting period at 
the TBT Committee. In a similar way, Indonesia adopted Decree 1360/2021 on materials excluded 
from the halal certification  obligation (G/TBT/N/IDN/1 40) on 27 December 2021, even before 
notification to the TBT Committee on 6 January 2022, without respecting the period for comments.  
2.59.   Indonesia is required to notify any relevant technical measures when still in draft form and to 
leave sufficient time for comments, as provided in Article 2.9.4 the WTO TBT Agreement. In addition, 
Indonesia is required, in accordance to Article 2.12 of the TBT Agreement, to allow a reasonable 
interval of no less than six months between the publication of the measure and its e ntry into force. 
The EU acknowledges the recent notifications by Indonesia of the final texts of the Regulation on 
International Cooperation and the Decree on materials excluded from Halal certification, via 
Addendum, respectively, on 27 April 2022 and 14 June 2022. The EU kindly invites Indonesia to 
provide a written reply to its comments of 12 May 2020 on Regulation 31/2018 on Processed Food 
Labelling (G/TBT/N/IDN/124 ). The EU thanks Indonesia for the consolidated general written reply of 
 
19 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing a common organisation of the markets in agricultural pr oducts and repealing Council Regulations 
(EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, OJ L 347, 20.12.2013, p. 
671. 
20 Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) 
No 1308/2013 o f the European Parliament and of the Council as regards applications for protection of 
designations of origin, geographical indications and traditional terms in the wine sector, the objection 
procedure, restrictions of use, amendments to product specificat ions, cancellation of protection, and labelling 
and presentation, OJ L 9, 11.1.2019, p. 2.  
21 For previous statements follow the thread under ID 502 . G/TBT/M/87  
 
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  7 March 2022, at the informative session o f 7 March 2022, covering several Members' comments on 
several implementing halal measures.22 Nevertheless, we invite Indonesia to reply in written to the 
EU specific comments for each of these measures.  
2.60.   The EU stresses the excessive restrictive impact on t rade of the adopted Halal Law and 
implementing provisions and invites Indonesia to consider less restrictive alternatives to the current, 
wide-ranging mandatory halal certification and labelling, in order to pursue the legitimate objective 
of ensuring reli able information for consumers without unduly hindering trade flows. Among the 
main issues of concern for the EU in the Halal Law and implementing measures are the "non-halal" 
information requested for non -halal products or the extension of halal requireme nts to products 
other than food and beverages. Furthermore, in order to ensure the workability 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 foreig n halal certificates. In particular, the pre -condition 
of a specific government -to-government mutual recognition arrangement for recognition by 
Indonesia of foreign halal certification bodies and certificates would appear unduly complex, 
represent an exces sive burden for economic operators and not allow for smooth trade relations. The 
EU looks forward to exploring more feasible and agile options with Indonesia.  
2.61.   The EU encourages Indonesia to recognise the EU -Partnership and Cooperation Agreement 
(EU-Indones ia PCA) as the umbrella or framework agreement to meet the requirements for a 
Government -to-Government Agreement with the EU and its member States, in recognition of the 
EU as a single market of its 27 member States. Similarly, the EU encourages Indonesia to continue 
to allow halal certification bodies (FHCBs) in a given EU member State to certify products in other 
EU Member States, as this is in line with the functioning of the EU single market. Clarification on 
transitional provisions for existing certifi cates would also be welcomed. Meanwhile, the exclusion of 
end-products from the coverage of foreign certification and the additional registration requirement 
for halal certifications of certain products by foreign halal certification bodies also appears to  be 
unduly unjustified, costly and duplicative. In addition, the EU is concerned about the possibility for 
Indonesia to impose much higher halal certification fees for goods and services from foreign 
businesses. The EU would also appreciate further clarifi cations on the criteria used for the list of 
materials excluded from the halal certification obligation and the procedure to review the list.  
2.62.   The EU stresses the importance of ensuring the continued possibility to place non -halal 
products on the Indonesian  market and urges Indonesia to review the halal measures with a view 
at adopting a more trade -friendly approach that does not create unnecessary obstacles. Notably, 
the EU firmly calls upon Indonesia to: limit halal requirements to food and beverages; avoi d the 
excessively burdensome requirement for mandatory "non-halal" information as regards non -halal 
products; clarify its approach to international cooperation on halal and provide for a flexible and 
pragmatic process for the recognition of foreign halal c ertification bodies and acceptance of foreign 
certificates, building on existing bilateral cooperation and working arrangements on halal 
certification; and provide information on the timeline for adoption and publication of the remaining 
measures to fully implement the Halal Law. The EU reiterates its willingness to continue further 
discussion and cooperation on halal issues with Indonesia, with the aim of finding a practical way 
forward and solve trade concerns.  
2.63.   The delegation of the United States  provided  the following statement. The United States 
acknowledges Indonesia's goal to provide reliable, relevant information regarding the halal integrity 
of certain products to consumers and we have sought to work with Indonesia, bilaterally and in 
multilateral se ttings, since 2015 to ensure that objective is achieved in a way that is consistent with 
Indonesia's WTO obligations. We urge Indonesia to continue bilateral engagement with WTO 
members and industry stakeholders. Unfortunately, many of our long -standing co ncerns remain 
unanswered. We refer Indonesia to our previous statement from March's TBT Committee, as well as 
outstanding questions submitted as G/TBT/W/761 . We ask that Indonesia respond to all the 
questions and concerns laid out in this document, as well as by all Members on the floor. As such, 
we will not repeat all of our outstanding concerns here.  
 
22 (i) Draft Government  Regulation (RPP) 39/2021 on Halal Product Assurance implementing the 
Omnibus Bill on Job Creation (G/TBT/N/IDN/131 ); (ii) draft Decree regarding types of products and consumer 
goods to be Halal -certified (G/TBT/N/IDN/134 ); (iii) Regulation on Halal fees (G/TBT/N/IDN/138 ); (iv) draft 
Regulation on international cooperation on Halal product assurance (G/TBT/N /IDN/139 ) and, (v) draft Decree 
on the materials excluded from the Halal certification obligation (G/TBT/N/IDN/140 ). G/TBT/M/87  
 
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  2.64.   We remind Indonesia of the obligation to notify draft me asures to the Committee before they 
take effect, allow a reasonable time for stakeholder comments, and take such comments into 
account before draft measures are adopted and implemented. Can Indonesia confirm whether there 
are further implementing regulatio ns for the Halal Law forthcoming, and if so, what is the expected 
timeline for notifying those regulations? To allow US industry time to adjust to these new 
requirements, and to allow Indonesia time to adequately clarify and answer WTO Members' 
outstanding  questions and concerns, we request that Indonesia postpone commencement of the 
Halal Law phase -in until Indonesia finalizes all of the relevant implementing regulations related to 
the Halal Law. We remain committed to working bilaterally with Indonesia to  address the 
aforementioned concerns, and those raised by other Members in this Committee, and to ensure that 
Indonesia's halal measures do not create unnecessary obstacles to international trade.  
2.65.   The delegation of Australia  provided the following statemen t. 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 businesses 
and trading partners. We encourag e 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. Australia is eager to ensure that our exis ting halal 
assurance processes will continue to be recognized when the grace period for Law 33/2014 ends in 
2024 and welcomes Indonesia's clarification of this. Australia thanks Indonesia for the informative 
Halal Assurance System Regulations information s ession held by the Indonesian Halal Product 
Assurance Agency (BPJPH) on 7 March 2022. We appreciated the opportunity to receive further 
clarification on previous TBT Committee notifications submitted by Indonesia concerning 
implementation of the Halal Law.  
2.66.   We welcome Indonesia's list of natural products that are exempt from the halal certification 
requirement, including fresh fruits, vegetables, grains, and some dairy products. Australia would 
appreciate further clarity on specific products that would be in cluded and excluded from halal 
certification under the Halal Law, as it was not clear why some processed food products – such as 
honey – were included and others – such as milk – were excluded. Australia thanks Indonesia for 
their recent verbal advice that  the Indonesia -Australia Comprehensive Economic Partnership 
Agreement will be utilised as an overarching government -to-government bilateral agreement for 
halal certification, and looks forward to receiving written advice to confirm this approach. We look 
forward to further dialogue on the Halal Law to ensure its implementation is no more trade restrictive 
than necessary.  
2.67.   The delegation of Switzerland  provided the following statement.  Switzerland is following this 
matter with interest and shares the concern s expressed by other Members regarding the Indonesian 
Halal Product Guarantee Law No 33 of 2014 and its implementing provisions, which require 
mandatory halal certification and labelling for a large range of products. While Switzerland 
recognizes Indonesia 's legitimate objective to ensure reliable information for consumers related to 
the halal integrity of certain products, we expect Indonesia to fully meet its WTO obligations. We 
believe that the halal implementing provisions should not be more trade restr ictive than necessary 
to ensure that the legitimate objectives are met and the products fulfill the halal requirements, as 
prescribed by the Islamic Law. Switzerland is concerned about the requested "non-halal" information 
for non -halal products or the ext ension of halal requirements to products other than food and 
beverages. We encourage Indonesia to reconsider the respective provisions of its recently adopted 
regulations.  
2.68.   Furthermore, Switzerland asks Indonesia to consider a more trade -facilitating approa ch 
related to the recognition of foreign halal certificates. The pre -condition of a government -to-
government mutual recognition arrangement for recognition by Indonesia of foreign halal 
certification bodies and certificates seems to represent a significant ly trade -restrictive policy 
approach. The additional registration requirement for halal certifications of certain products by 
foreign bodies also appears to be more trade restrictive than necessary. In this respect, we 
encourage Indonesia to provide flexib ility for the recognition of foreign halal certification bodies and 
the acceptance of foreign halal certificates. Finally, Switzerland encourages Indonesia to notify any 
relevant technical measures when still in draft form and to provide sufficient time fo r comments, in 
accordance to the WTO TBT Agreement.  
2.69.   The delegation of Canada  provided the following statement. Canada appreciates Indonesia's 
positive engagement bilaterally to move forward with the accreditation of Canadian halal certification G/TBT/M/87  
 
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  bodies. Can ada hopes that further progress can be made so exports of certified halal food products 
can resume in the near term. While Canada appreciates this progress, a number of concerns remain 
and Canada would appreciate that Indonesia provide written responses to  its comment letters on 
G/TBT/N/IDN/139  and G/TBT/IDN/14 0. Without full and complete information, it will be difficult for 
Canadian producers to ensure their production processes fully comply with Indonesia's halal regime. 
While Indonesia has taken steps to clarify the scope of products that will require halal certification, 
confusion remains. The only way to be clear about what products require certification is to provide 
specific HS codes for each product that requires halal certification. There are also issues of 
consistency. For example, while we are pleased  to see that frozen fish appears to be exempted from 
the halal requirement, other frozen seafood products are not listed. Canada would appreciate 
confirmation, in writing, that frozen fish and seafood that is not otherwise processed will be exempt 
from hal al certification requirements.  
2.70.   Further, there is confusion around whether genetically modified plant products require halal 
certification. Canada would appreciate if Indonesia could clarify whether genetically modified 
products that are not otherwise proce ssed require certification and if so, why. Canada appreciates 
Indonesia's efforts in notifying these measures, however, we would like to remind Indonesia of its 
WTO transparency obligations to provide trading partners with adequate time and information to 
comment on a given measure and to ensure that these comments are taken into consideration prior 
to that measure being finalized.  
2.71.   The delegation of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. We would  like to support the delegations of the United States, 
European Union, Australia, Switzerland and Canada. We are aware that on 2 February 2021 the 
Indonesian Government issued regulation No. 39 of the Halal Product Assurance Law for 
implementation. It stip ulates that only products with halal or non -halal labelled information can be 
imported and distributed in the Indonesian market. Since this law and its draft implementing 
regulation affect the trade of numerous products and Indonesia's halal certification bureau (BPJPH) 
has to date not yet completed mutual recognition with any foreign halal institutions, we urge 
Indonesia to provide clear and explicit information on mutual recognition certification between the 
BPJPH and foreign halal institutions.  
2.72.   The deleg ation of New Zealand  provided the following statement. New Zealand thanks 
Indonesia for its ongoing engagement on the implementation of the Halal Assurance Law and 
associated implementation regulations to date. New Zealand respects Indonesia's desire to in crease 
the robustness of the halal assurances associated with products moving into commerce in Indonesia. 
However, we are also very interested in working with Indonesia to ensure the halal certification 
controls and systems operating in New Zealand are rec ognized without the application of restrictive 
additional inspection, control or approval processes and associated costs. We ask for some clarity 
on the status of Overseas Halal Certification Bodies who were previously listed with MUI, and the 
timelines fo r their registration with BPJPH. Is there a deadline for their registration and will this 
registration need to be periodically renewed? With regard to the recently -released Ministry of 
Religious Affairs regulations 748/2021, can Indonesia please clarify bo th the criteria and process, 
including WTO notification and consultation, by which items are added to the appendix listing the 
type of product that is obliged to be halal certified? The regulation reads that the head of BPJPH is 
obliged to include a produc t on the list if a business actor has applied for halal certification for a non -
listed product. Will there be a WTO -consistent notification and consultation process and an 
appropriate grace period after products are added to the list that will allow other business actors 
enough time to apply for halal certification? Can Indonesia clarify the mechanism by which the 
updated list will be notified publicly?  
2.73.   In response, the delegation of Indonesia  provided the following statement. Indonesia would 
like to refer to its statement on the previous TBT meeting on March 2022. Moreover, Indonesia has 
provided clarification to all questions raised by the Members in the informative session on 7 March 
2022. Therefore, we would like to ask Members to refer to the document t hat was sent to all 
participants from the Members. Indonesia once again would like to reiterate its openness and 
transparency to international cooperation on Halal Assurance System based on the principle of 
mutual cooperation, mutual recognition, and mutua l acceptance in accordance with international 
regulations and practices.  G/TBT/M/87  
 
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  2.1.3.4   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53323) 
2.74.   The delegation of the European Union  provided the following statement. The EU has raised 
the Security Review of Network Products and Services, among many aspects of the Cybersecurity 
Review Measures, in this Committee on several occasions, stressing our concerns related to these 
measures, whi ch entered into force on 1 June 2020 and were subsequently amended in January 
2022, and entered into force on 15 February 2022. We remain concerned that the measures are 
quite general and very broad discretionary powers are left to the authorities in charg e of the security 
review, raising concerns for foreign ICT operators. The Amended Measures contain few explanations 
of the issues we raised before and new issues have arisen since. The EU regrets that the Measures 
were adopted without a longer grace period , of at least 12 months, so that companies would have 
sufficient time to prepare for compliance with the Amended Measures. The Amended Measures have 
significantly increased the scope of application and many operators need time to understand and 
cope with t heir compliance obligations and the related business impact.  
2.75.   The Measures expand the scope of the application from Critical Information Infrastructure 
Operator's (CIIO) purchase of network products and services, to online platform operators carrying 
out da ta processing activities. The expanded scope is very broad. For all the other data processors, 
which are not Critical Information Infrastructure Operators nor IPO need, it has left huge uncertainty 
as to whether or not the review is required and whether or  not the data processors shall submit a 
review to the regulator. It is unclear who would be a "data processor " or when they would be engaged 
in "data processing activities ". Understanding the scope of a data processor engaged in such 
activities would be ne cessary to the extent that it determines if and when an application would have 
to be filed. The EU urges China to clarify if "a data processor carrying out data processing activities " 
applies only to a data processor registered in China and processing data  in China, and excludes 
overseas data processors that process data outside of China.  
2.76.   The EU seeks clarification on the following points: The continued use of "listing in a foreign 
country ". Does this indicate the regulatory intention to exclude operators l isted in Hong Kong from 
the obligation of applying for a mandatory Cybersecurity review? Based on the previous draft, 
entities subject to Cybersecurity reviews have changed from "data processors " to "online platform 
operators ". The final Measures do not de fine "online platform operators ", but the Draft Regulations 
define it as "data processors who provide Internet platform services such as information publishing, 
social networking, transaction, payment or audio -visual services ". The EU urges China to clarif y if 
the scope of "online platform operators " is narrower than "data processors ", which was used 
previously and excludes self -operated e -commerce services of fast -moving consumer goods 
companies that do not provide online platform services. The vagueness o f "online platform 
operators " leaves room for interpretation by regulators. Neither "core data " nor "important data " 
are clearly defined. The Measures include important telecommunication products as one kind of 
"network products and services ". However, the Measures still do not provide a specific scope of 
"network products and services ". This leads to the definition of "important communication product " 
to be even more unclear. The EU urges China to clarify these terms as soon as possible. The EU 
urges China to ensure clarity, transparency and objectiveness in the security review so that the 
Measures do not become a marke t access barrier.  
2.77.   The delegation of Japan  provided the following statement. Japan continues to have interest 
in and concerns regarding the Cybersecurity Review and would like to refer to the previous statement 
we made at the last TBT Committee in March 202 2. China enforced the amendment of the Measures 
for Cybersecurity Review in February 2022. It is unclear whether the definition and scope of "Critical 
Information Infrastructure Operator " refers to the definition of "Critical Information Infrastructure" 
provided under the Regulations on the Security Protection of Critical Information Infrastructure, and 
there is no definition for "Network Platform Operator". Therefore, it is uncertain what kind of 
businesses could be subject to the Measures for Cybersecurit y Review. Japan would like to request 
that China operate the regulations transparently for predictability without hindering business.  
2.78.   In response, the delegation of China  provided the following statement. In recent years, with 
the development of network in formation technology and further opening -up of networks in China, 
more and more network products and services have been determined as critical information 
infrastructure, while some people take advantage of providing products and services to illegally 
 
23 For previous statements follow the thread under ID 533 . G/TBT/M/87  
 
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  obtain users' important data, control and interfere with critical information infrastructure operation, 
stop the supply of its technologies, products, and services for non -technical or commercial reasons, 
which poses serious risks and challenges to national cy bersecurity of China, especially the supply 
chain security of critical information infrastructure. Drawing on common international practices, 
China formulated the Draft implementing measures for the Cybersecurity Review of Network 
Products and Services in 2017. In June 2020, the Measures for Cybersecurity Review came into 
effect, while the Draft implementing measures for Cybersecurity Review of Network Products and 
Services (Trial) was abolished at the same time. On 15 February 2022, the revised Cyber Secur ity 
Review Measures came into force.  
2.79.   The establishment of the network security review system aims to detect and avoid risks and 
hazards brought to critical information infrastructure by purchased products and services, ensure 
the supply chain security of c ritical information infrastructure and safeguard national security 
through network security review. The Chinese authority administers the internet in accordance with 
laws and regulations and strengthens cybersecurity and data security management. This is n ot only 
necessary to safeguard personal information security and national security, but also the common 
practices of other WTO Members. Taking this opportunity, I would like to reiterate that, unlike some 
Members, the security review of China does not disc riminate against foreign technologies and 
products or restrict the entry of foreign products into the Chinese market. China will, as always, 
welcome foreign products and services to enter the Chinese market as long as they comply with the 
laws and regulati ons. 
2.1.3.5   European Union - Transitional periods for MRLs and international consultations 
(ID 58024) 
2.80.   The delegation of Colombia  provided the following statement. Colombia reiterates its concern 
regarding the international consultation processes adopted by the European Union (EU) and the 
transition periods granted prior to the entry into force of provisions under which the EU no longer 
approves the marketing of certain plant protection substances and amends maximum residue limits 
(MRLs).  These concerns are being  reiterated because the EU has so far not responded to any of the 
requests concerning the granting of longer transition periods and has failed to take into consideration 
the comments made during international consultation periods.  Regulatory changes on the  use of 
plant protection substances, coupled with such short periods of transition, create difficulties and 
uncertainty for fruit and vegetable producing countries. They also create additional 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 well as for processed and frozen foods, as, 
despite complyi ng with European standards at the time of sowing, they may face regulatory changes 
that prevent exports at the time of harvest and distribution.  Furthermore, Colombia maintains that 
notification to the WTO of non -renewal, the MRLs to be applied and transit ion periods should not be 
made by the EU as a simple formality within the regulatory process. As provided in Articles 2.9.2 
and 2.9.4, the notification must be submitted within a time frame that allows the Members concerned 
to submit substantive observatio ns and comments for genuine consideration by whoever is 
developing the technical regulation, in this case the Commission.  
2.81.   Moreover, within the framework of this Committee, it cannot be acceptable for the European 
Union to state that, as soon as the Europea n Food Safety Authority (EFSA) recommendation and the 
Standing Committee on Plants, Animals, 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.  In that connection, we would like to ask the EU how it 
has taken into account the comments submitted by Members at different stages of the consultation 
process. Are there cases in which regulatory changes or adjustm ents have been effectively 
introduced using the information submitted by stakeholders during the consultation process? How 
have comments been used to determine the transition periods for the implementation of standards?  
In addition to these questions, whic h we have raised previously and to which we have still not 
received clear answers, there are the questions that we have raised in other settings about the use 
of emergency authorizations, which benefit producers in the EU and in selected non -EU countries, 
but which are not accessible on equal terms to all WTO Members.  We invite the EU to follow the 
recommendations on good regulatory practices, under which standards must be based on clear and 
objective information, and which promote open dialogue with stakeh olders, transparency and the 
 
24 For previous stateme nts follow the thread under ID 580 . G/TBT/M/87  
 
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  minimizing of market distortions.  Colombia once again welcomes the opportunity to express its 
concerns on this issue.  
2.82.   The delegation of the United States  provided the following statement. We continue to raise 
our concern about the European Union's (EU) practices in regard to the enforcement and reduction 
of pesticide maximum residue levels (MRLs). We recall longstanding concerns that while trading 
partners do not know with certainty what the impact of the EU's active substance n on-approval or 
restricted approval decisions will be on future MRLs, we notice that EU MRLs and import tolerances 
have often been reduced or withdrawn following a non -approval or restricted approval decision. Such 
actions may be more trade restrictive than  necessary to meet the EU's legitimate objectives. To 
prevent food waste and to forestall food insecurity, we request the EU to extend transitional periods 
for MRLs where the EU has not identified risk to consumers based on dietary exposure and to allow 
adequate time for US and third country producers to move lawfully produced food products through 
the channels of trade, including shelf -stable products that have long shelf lives. In addition, we 
reiterate our concern about the EU's consideration of import t olerance applications. Our past 
experience indicates that the review of additional data is often only considered after the EU notifies 
its intention to not approve a renewal or to approve a renewal on a restricted basis.  
2.83.   Once again, the United States reite rates its request that the EU retain existing MRL levels 
while import tolerances are under consideration, and that the EU fully complete science -based risk 
assessments, taking all available evidence into account, prior to reducing MRLs. The EU's policy of 
enforcing MRLs at the time of importation for imported goods instead of at the time of production as 
applies for domestic goods, is an inconsistency that causes disruptions in trade for products destined 
for the EU market. Trading partners have found thems elves racing to move shipments through 
customs to prevent rejections or turning back orders because a product that complies with an 
existing EU MRL standard at the time of production could face rejection at EU borders. EU growers 
do not face the same timel ines under the current regulatory provisions. We therefore again request 
that imported products' MRLs be considered on the EU market at the time of production, the same 
as for European products.  
2.84.   The delegation of Costa Rica  provided the following statement . We reiterate our support for 
this trade concern. As it has done in previous meetings, Costa Rica reiterates its request for an 
extension of the transition periods for compliance with the new tolerances established for various 
substances, in view of the i mpact they have on agricultural production in our countries.  
2.85.   The delegation of Paraguay  provided the following statement. As with other similar concerns 
and previous meetings of this Committee, the SPS Committee and the Council for Trade in Goods, 
we are c oncerned that the European Union's approach to limiting the use of substances is more 
trade -restrictive than it needs to be for it to achieve its legitimate objectives under the TBT 
Agreement. Likewise, the reduction of MRLs, on the basis of the argument t hat it is impossible to 
determine whether the use of many substances is safe and the lack of conclusive scientific evidence, 
even in cases where the Codex Alimentarius has identified certain substances as being safe, is not 
in line with Members' obligation s under the SPS Agreement. With regard to the EU's customary 
refusal to discuss MRLs in the framework of this Committee, its recent TBT notification concerning 
the reduction of MRLs for certain substances is striking. Perhaps this means that the EU will fi nally 
be in a position to answer concrete questions and address this concern that has repeatedly been 
raised in this and other committees, only to receive unsatisfactory answers and no follow -up at all.  
2.86.   The pursuance of such policies will cause significant  trade damage to the economies of 
developing countries and jeopardize their ability to achieve the Sustainable Development Goals, 
including those related to food security. We urge the EU to: reassess its approach; base its decisions 
on conclusive scientifi c evidence and real risk weightings, in accordance with the relevant 
international principles and standards; ensure import tolerances; and, where necessary, provide 
adequate transitional periods that take into account the realities of the production proces ses and 
geographical locations, including distances, of its trading partners.  
2.87.   The delegation of Brazil  provided the following statement. Brazil supports the concerns raised 
under STC 580 and would like to refer to our previous statements on this agenda ite m. We 
respectfully bring to the attention of the EU its obligations under Article 2.12 of the TBT Agreement, 
which relate to the establishment of a reasonable interval between the publication of technical 
regulations and their entry into force, except in c ases of urgent problems of safety, health, 
environmental protection or national security. It is of utmost importance that the EU provides G/TBT/M/87  
 
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  adequate transitional periods, especially for those cases in which the scientific opinions of the EFSA 
on the toxicity  of substances are "inconclusive" or only indicate a "suspected risk". Transitional 
periods should also be compatible with the production processes, so as to allow producers – and 
especially small farmers – to adapt to the new regulations.  
2.88.   The delegation o f Canada  provided the following statement. Canada would like to reiterate its 
concern with the EU's approach to transition periods for maximum residue limits. Canada considers 
the sudden deletion of MRLs to be disproportionate to the level of risk to human  health and more 
trade restrictive than necessary. While Canada appreciates the EU's clarification during the recent 
WTO SPS Committee, Canada is of the view that the EU's approach has yet to acknowledge the 
reality of agricultural supply chains such as th e time required to ship product, multi -year inventory 
and extensive shelf life, including in foreign countries. Sufficient transition periods will allow trade 
to continue uninterrupted, while providing adequate time for producers and exporters to adapt to 
the new EU requirements. At a time when ensuring food security is of high concern, 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.  
2.89.   The delegation of Peru provided the following statement. Peru shares the concerns raised by 
other Members, including Colombia and the United States, and supported by Costa Rica, Paraguay, 
Brazil, Canada, Uruguay, Ecuador, Guatemala and Panama. These measures create additional 
burdens for agricultural producers, who must make decisions regarding the use of phytosanitary 
products a year before the final product reaches the European market. This is particularly complex 
for products with  long production and harvest cycles, as well as for processed and frozen foods. It 
is very important for the European Union to provide adequate transitional periods in which to raise 
awareness in the food production sector and to ensure that effective subs titutes for the active 
ingredients for whose MRLs a reduction is sought are available on the market.  
2.90.   The delegation of Uruguay  provided the following statement. In view of harvesting periods, 
the stages at which plant protection products are applied, and the time required to develop and 
register alternative substances in practice, the transitional periods granted by the European  Union 
in the provisions amending MRLs for active substances do not provide enough time to make the 
necessary adjustments to production and ensure that agricultural products, especially processed or 
frozen products, comply with the new, lower MRLs. Like oth er Members, Uruguay does not consider 
six months to be a sufficient period in this regard. In our view, any changes should be gradual, and 
a reasonable period of time, of at least two years or two harvests, should be granted to raise 
awareness in the produ ction sector and among technical advisers, and to ensure that effective 
substitutes for the active ingredients for whose MRLs a reduction is sought are available on the 
market. It is inappropriate to change the rules drastically in the middle of a harvest season, given 
the impact this may have on international and domestic marketing. My delegation reiterates its call 
on Members to adopt regulatory decisions based on internationally accepted standards or to provide 
conclusive scientific evidence when it is s trictly 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 adequately and sufficiently 
long to make the relevant adjustments.  
2.91.   The delegation  of Ecuador  provided the following statement. My country wishes to reiterate 
its concern regarding the "transition periods" granted by the European  Union (EU) for implementing 
its measures relating to the non -renewal of the use of substances and the reduct ion of tolerances.  
Farmers, especially in developing countries, 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. 
Therefore, it is necessary to establish reasonabl e transition periods that take into account harvesting 
periods and the times when agrochemicals are applied.  Ecuador is aware that the EU allows its 
farmers to request emergency authorizations so that, in certain particular situations, they can use 
active substances that have already been banned in the European market.  Ecuador wishes to 
reiterate its request to the EU to know whether, where emergency authorizations are issued for the 
use of such substances, EU member countries have notified and justified th e 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 of prohibited substances is comp lying 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 G/TBT/M/87  
 
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  substances have not been marketed in other EU member States. We kindly ask it to respond to 
these concerns.  
2.92.   The delegation of Guatemala  provided the following statement. Following the lowering of 
maximum residue levels (MRLs) notified by the European Union, Guatemala wishes to reiterate the 
importance of establishing transitional periods that closel y 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, to find alternative substances, which in some cases means having to wait for 
suitable product ion cycles to commence application and testing.  We reiterate our concern that our 
ideas for discussions focused on finding solutions have not been listened to and accepted. The trade 
concern regarding this issue focuses on safeguarding agricultural produce rs and exporters sending 
their goods to the European Union, who will be affected by this market's change in conditions.  We 
would be highly grateful if the European Union would consider the following:  launching genuine 
dialogue to discuss the importance of establishing transitional periods that closely follow the stages 
of crop production, following the lowering of MRLs for active substances that are commonly used for 
the phytosanitary treatment of these crops;  extending the transitional period, with a view to 
preventing the obstruction of trade, and giving time for developing countries with tropical climates 
to adapt ; providing clarification on why our comments on this process in the WTO are not taken into 
account within the regulations.   
2.93.   The delegation of Panama  provided the following statement. In the interest of time, we refer 
to our previous comments on this matter. Panama remains deeply concerned over the transitional 
periods for compliance with the new MRLs. We urge the EU to follow good regulatory prac tices and 
to respect its obligations under Article 2.12 of the TBT Agreement.  
2.94.   The delegation of Argentina  provided the following statement. The EU policy of removing 
import tolerances for substances that are no longer used in the EU is clearly a more restr ictive 
measure than necessary and goes beyond the acceptable level of risk set by the EU. The approach 
taken by the EU to establish transitional periods for MRLs is hasty and does not take into account 
the needs and adaptive capacities of third parties. Th e transition period clearly needs to be longer, 
and Argentina therefore calls for a review of the transition periods.  
2.95.   In response, the delegation of the European Union  provided the following statement. The EU 
has provided detailed information on transition al periods for Maximum Residue Levels (MRLs) at 
previous TBT Committees, in particular, at the TBT Committee meeting in May 2020. The EU 
considers that measures lowering maximum residue levels due to concerns for human health, fall 
under the remit of the S PS Committee and should be discussed in that context. On the contrary, all 
measures concerning non -approval or restriction of active substances 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. The EU considers furthermore that, a limited number of very 
specific measures lowering MRLs due to environmental issues of global concern (e.g. clothianidin 
and thiamethoxam), should be notified to the TBT Committee.  
2.96.   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. In practice, both Committe es are informed about 
draft acts on the non -approval or restriction of approval of an active substance in the EU. However, 
comments should only be submitted via the TBT notification system in those cases. 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.  
2.97.   In the interest of efficient proceedings in both Committees and, in line with the respective 
Agreements, the EU would invite Members to raise matters on approvals of active substances and 
measures dealing with MRLs in view of environmental issues of global concern exclusively in the TBT 
Committee, while matters relating to MRLs for pesticides due to human health concerns should be 
raised exclusively in the SPS Committee. Issues concerning transitional periods for MRLs should 
therefore generally be raised at the Committee to which the original notification was made, which 
would be, in  most cases, the SPS Committee.  G/TBT/M/87  
 
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  2.1.3.6   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (ID 60225) 
2.98.   The delegation of the European Union  provided the following statement. The European Union 
would like to refer again to the Qatar's Minist ry of Public Health Circular of 30 May 2019 establishing 
new import requirements for UHT milk and white cheese that entered into force already in 2019. 
The scope of these measures was further expanded with Qatar's Council of Ministers instructions 
issued i n August 2021. Regrettably, these measures affected several dairy products exported from 
the EU to Qatar and the European Union would like to recall the importance of addressing these 
concerns. During the previous TBT Committee meeting in March, Qatar info rmed that the Circular 
had been suspended, while awaiting for an internal review process. On 28 April 2022, Qatar approved 
a new Circular which removed some of the proposed restrictions on the shelf life of dairy products. 
However, these were re -introduced  a few days later, on 1 May 2022, by a new Circular. The EU is 
concerned about the lack of predictability on the rules that operators need to follow, as well as lack 
of sufficient time to adapt to any regulatory changes. Could Qatar clarify if there are an y currently 
applicable exceptions for the exports of dairy products to Qatar? We would like to urge Qatar to 
adopt a permanent solution which will avoid trade disruptions. In this respect, the European Union 
would like to insist on the need to notify any p roposed measure at a draft stage to this Committee. 
The European Union is grateful that we had further constructive exchanges with Qatar on this matter, 
where Qatar signalled to be working on a solution to be offered in a near future. We stand ready to 
continue to work constructively with Qatar to resolve this important issue in due course.  
2.99.   The delegation of New Zealand  provided the following statement. New Zealand joins the EU 
in expressing concern about Qatar Ministry of Public Health's Circular of 30 May  2019 establishing 
new import requirements for UHT milk and white cheese, and the subsequent expansions in the 
scope of the circular's application. These stringent restrictions on shelf life severely disadvantage 
imported products in Qatar's market, in rel ation to local products. Compliance with many of these 
requirements is not feasible for a range of New Zealand's dairy products. The measures appear to 
be more trade restrictive than necessary to fulfil the legitimate objective of public health protection.  
New Zealand recommends consideration is given to applying internationally recognised standards 
such as Codex Alimentarius if scientific justification for these measures is unable to be provided.  
2.100.   In response, the delegation of Qatar  did not make a statemen t during the meeting. A 
technical statement was circulated following the meeting.26 
2.1.3.7   Bangladesh - Hazardous Waste (E -waste) Management Rules, 2019, 
G/TBT/N/BGD/3 , G/TBT/N/BGD/3/Add.1  (ID 62027) 
2.101.   The delegation of the United States  provided the following statement. As noted at the last 
meeting, we remain interested in the status of Bangladesh's updated draft of its Hazardous Waste 
(E-Waste) Management Regulation, 2021 (E -waste Rules), pu blished in June 2021. We again ask 
that Bangladesh notify this updated draft. We would also appreciate knowing Bangladesh's timeline 
for considering public comments before finalizing the E -waste Rules and for implementing the 
measure. As previously noted, we continue to lack clarity regarding how Bangladesh plans to 
implement the E -waste Rules. We therefore remain interested in receiving the information requested 
in our previous statements on this STC. We also encourage Bangladesh to make this information 
available to the public, so that industry can engage regulators and comply with the E -waste Rules. 
We look forward to an update from Bangladesh.  
2.102.   In response, the delegation of Bangladesh  provided the following statement. Bangladesh 
circulated a draft regula tion on Hazardous Waste Management (E -Waste) Management Rules 2019 
on 20 February 2020 through G/TBT/N/BGD/3  and requested for comments. Later by another 
notification, G/TBT/N/BGD/3/Add.1 , dated 26 May 2020, Bangladesh extended till 30 June 2020. 
Several Members including the US and their private sector s made comments on the draft regulation. 
The Government of Bangladesh updated the regulation based the recommendations by Members 
and based on international standards after several virtual consultations with the interested Members 
and their private sectors . On 10 June 2021 Bangladesh Government published the revised regulation 
named as "Hazardous Waste (E -Waste) Management Rule, 2021". Government of Bangladesh 
revised threshold limits for certain hazardous wastes under Schedule 3 of the said rules consideri ng 
 
25 For previous statements follow the thread under ID 602 . 
26 G/TBT/W/773 . 
27 For previous statements follow the thread under ID 620 . G/TBT/M/87  
 
- 27 - 
 
  the suggestion of the US and other countries. The US industries shared their concerns in September 
2021. Bangladesh also notified the name of the notification authority and the enquiry points in the 
revised rule.  
2.103.   The Rule 14(2) of Hazardous Waste (E -Waste) Management Rules, 2021 has given flexibility 
on the "threshold limits for certain hazardous wastes " which states : "The use of hazardous 
substances in the production of electrical and electronic products shall be reduced within 5 (five) 
years from the d ate of enforcement of the Rules to bring them in line with the above standards. " 
However, it is also stated that the Government may extend this period, if necessary.  Any legitimate 
concern raised by Members during this period will also be considered positi vely. Bangladesh likes to 
refer to Schedule 2 of Hazardous Waste (E -Waste) Management Rules, 2021, where we have given 
targets for e -waste collection and its management. No deadline for registration is mentioned  in the 
rules. Department of Environment has started the registration process. After COVID -19 and 
changing circumstances, things have been becoming normal and Bangladesh Government has 
started sensitization of stakeholders through workshops and seminars. The rule is available on -line 
from the DoE website28 and the following officials can be contacted .29 
2.104.   The Government of Bangladesh has been working with a detailed explanatory guide lines for 
the implementation of the Regulation. The Regulation will be effective from 2026 and by this time 
the guideli nes will be published.  Article 2 .12 of the WTO TBT Agreement suggested to provide a 
"reasonable interval " before enforcement of TBT regulations. As per p aragraph  15 of the Decision , 
G/TBT/M/26 , 6 May 2002, and para. 5.2 of the Doha declaration number WT/MIN(01)/17 , 
20 November 2001, the reasonable period suggested is not  less than 6 (six) months. The 
Government of Bangladesh has kept a five -year time period for industries to use Hazardous 
Substances in the Production of Electrical and Electronic Products as stated in Rule 14 of Hazardous 
Waste (E -Waste) Management Rules, 2021. We believe the time period is quite comfortable for the 
industries and it is compliant with the WTO TBT Agreement and relevant decisions. Over the last 
two-three years the Government of Bangladesh has been accommodating the concerns of different 
WTO Members and their private sectors. The Government has revised the regulation as per the 
"Threshold limits for use of certain hazardous substances " based on the EU standards . Bangladesh 
is on the opinion that it has adopted widely accepted global standards for e-Wastes and hence all 
the concerns raised by Member countries have been resolved. Bangladesh is looking forward to work 
with the US to further clarify any issues. Bangladesh believes all the legitimate concerns of the US 
and other Members have been ac commodated and we request Members to consider the STCs are 
resolved.  
2.1.3.8   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 66230) 
2.105.   The delegation of Canada  provided the following statement. Canada would like to raise this 
specific trade concern regarding Panama's quality requirements for fresh potatoes established by 
the Ministry of Industry and Commerce on 20 February 2020. As a long -standing supplier of fr esh 
potatoes to Panama with year -round exports, Canada continues to be concerned that implementing 
these new quality requirements could have a direct impact on our ability to export potatoes to 
Panama. Canada recognizes that Panama delayed the implementati on of these measures to allow 
for further consultations with trading partners and is appreciative of Panama's participation in a 
bilateral technical meeting which was held in September 2021, to address elements of concern on 
this issue. However, despite th is positive engagement, Canada notes that our concerns were not 
taken into account by Panama its final measure. Canada has signalled our concern to Panama's 
Ministry of Commerce (MICI) with the restrictive time limits for storage and marketing, as well as 
the zero tolerance for sprouting. Canada respectfully requests that Panama pause the enforcement 
of these requirements to allow for additional technical dialogue to occur and ensure that Panama's 
quality standards do not create unintended barriers to our m utually beneficial bilateral trade in 
agriculture.  
 
28 www.doe.gov .bd 
29 Mr. Md. Mohammad Abdul Wadud Chowdhury , Deputy Secretary, MoEFCC, E -mail: 
env2moefcc@gmail.com ; Mr. Mirza Shawkat Ali , Director, DoE, E -mail: mirzasa1@yahoo.com ; 
dircc@doe.gov.bd . 
30 For previous statements follow the thread under ID 662 . G/TBT/M/87  
 
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  2.106.   The delegation of the United States  provided the following statement. We would like to 
support the comments made by Canada and we refer to our previous statements on this issue.  
2.107.   In response, the delegatio n of Panama  provided the following statement. We take note of  
these concerns, which will we convey to Panama City. As noted by the Canadian delegation in its 
statement, we are pleased to report that our delegations have maintained a very open bilateral 
dialogue. Panama has proven its receptiveness to the comments and concerns of its trading partners, 
as evidenced earlier this year when it postponed the entry into force of the amendment for potatoes 
by six additional months. We reiterate our willingness to w ork with our trading partners to seek 
mutually satisfactory solutions.  
2.1.3.9   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 64931) 
2.108.   The delegation of the European Union  provided the following stateme nt. India continues to 
define and introduce specific standards and certification requirements for a number of products – 
under the umbrella of the Quality Control Orders (QCOs). The QCOs require physical audit at 
manufacturers' premises by an auditor of th e Bureau of Indian Standards (BIS) in order for products 
manufactured in third countries to receive the approval for exports to India. In view of the still 
existing post -pandemic challenges this process is still slow and often results in delays. The EU dee ply 
regrets that India repeatedly refused to consider meaningful alternative options to foreign audits –
such as virtual audits or audits conducted by internationally recognized third agencies/entities. The 
EU welcomes the fact that applications for inspect ions are processed gradually. However, the EU 
would like to stress the benefits that virtual audits and recognition of laboratories outside India 
would have for India and its partners. The EU would therefore like to take this opportunity to request 
Indian authorities to consider preparing rules for international recognition of laboratories by the BIS, 
as foreseen by legislation in place. This would speed up audits, and lower the cost of mandatory 
testing for foreign manufacturers.  
2.109.   Delays in foreign audits m ean that EU companies, despite doing all that is necessary to meet 
the Indian requirements, are not able to obtain the required Indian certification or marking. At the 
same time, Indian auditors are conducting domestic audits that allow domestic companies to receive 
certification/marking and place their products on the market, thus according an unfair first mover 
advantage to these domestic companies. The delays in physical audits out of India perpetuates the 
current difficult situation of EU importers, pro longing the discrimination between local and foreign 
companies. The EU hopes that the backlog resulting from delayed audits can and will be cleared in 
a transparent and non -discriminatory manner. The EU would like to reiterate its stance that the 
QCOs in q uestion have a protectionist orientation. The increasing number of QCOs across sectors is 
sending worrying signals to EU industry, EU investors, and EU member States. Once these QCOs 
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 for products 
already certified under established international standards. Furthermore, the foreign manufacturers 
have to make necessary modifications in their tooling systems for the ISI mark, which could cause 
temporary shutdown of some production lines. In this context, the QCOs add little value for Indian 
consumers, making the reason of their introduction not evident.  
2.110.   The EU understands that physical  audits have limited validity of two years only, after which 
the procedure for renewal of authorization is not clear. The current procedure is already unduly 
cumbersome and costly. Requiring a renewal every two years adds to the difficulty of doing busines s. 
At a time when businesses across the world have been heavily impacted by the SARS COV -2 
pandemic, it would be important to facilitate trade. India should consider giving longer validity period 
beyond two years and renewals should be given for a longer p eriod beyond five years. In this context 
the EU welcomes India's decision to further postpone the QCO on wheel rims, to 22 June 2023. The 
EU welcomes this decision which will ensure the continuity of imports of wheel rims into India. The 
EU would also like  to thank India for the earlier postponement of the QCO on safety glass until 1  April 
2023. The EU would like to reiterate that safety glass and wheel rims manufactured in the EU are 
subject to a rigorous certification process, in line with established int ernational standards, which are 
not much different from the Indian ones, introduced by relevant QCOs. The EU would, therefore, like 
to repeat its suggestion to keep the BIS marking as optional for components, which are already in 
 
31 For previous statements follow the thread under ID 649 . G/TBT/M/87  
 
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  compliance with the UN mar king requirements. The EU would like to ask India, if it would be ready 
to accept provisionally UN certificates and markings. In light of this, the EU would like to request 
India to reconsider the introduction of the QCOs on automotive safety glass and whe el rims. 
Furthermore, the EU recalls its suggestion to keep the BIS marking as optional for components, 
which are already in compliance with the current marking requirements.  
2.111.   In response, the delegation of India provided the following statement. As acknowl edged by 
the EU, India has already postponed entry into force of subjected QCOs. The products under 
mandatory certification are notified by the concerned Line Ministries (Regulator) of the Government 
of India through the issuance of Quality Control Orders (QCOs). As per the provisions of the QCO, 
the products specified therein shall bear a Standard Mark under a valid licence from BIS as per 
Scheme -I of the BIS (Conformity Assessment) Regulations, 2018. Under this Scheme, factory 
inspection is a mandatory re quirement for the grant of licence. Licence to use the Standard Mark on 
a product is granted after assessing the manufacturing and testing capabilities through factory 
inspection of the manufacturing premises. During this visit, conformity of the product t o the 
requirements of the relevant Indian Standard is also established through in -house factory testing or 
testing at a third -party testing laboratory or a combination of both. At present, there is no provision 
in BIS (Conformity Assessment) Regulations, 2 018, to undertake virtual audits for conformity 
assessment activities as an alternative.  
2.112.   Foreign inspections were on hold due to the prevalent restrictions on international travel 
imposed. As the COVID -19 restrictions have eased out, BIS has started carryi ng out inspection where 
confirmation for travelling of fully vaccinated BIS officers has been received. BIS has nominated 
officers and applicants are asked to remit the inspection charges for carrying out inspection. On 
receipt of inspection charges, inspe ctions are being planned. Preliminary inspection for more than 
100 applications has already been carried out. However, in some cases inspection are being delayed 
due to difficulty in issuance of VISA.  
2.1.3.10   China - Commercial Cryptography Administrative Regulati ons (ID 64432) 
2.113.   The delegation of the European Union  provided the following statement. The EU is concerned 
about this implementation measure of the Cryptography Law, and sent comments to the State 
Cryptography Administration of the People's Republic of Chin a (SCA) in September 2020. 
Specifically, concerns relate to (i) the scope of the law; (ii) the lack of clarity of concepts and 
precision of procedures; (iii) the protection of intellectual property; (iv) the imposition of pre -market 
& export controls; (v) the vague requirements around testing and certification and the turning of 
voluntary certification requirements into de facto market access prerequisites; (vi) the imposition of 
additional "national security reviews"; and (vii) the use of domestic standard s, 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 requiremen ts 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 Working Group 3 on 
Cryptographic Technology of the National Information Security Standardisation Technical Committee 
(TC260) and the "Cryptography Industry Standardisation Technical Committee" (CISTC) to foreign -
invested industry based in China. The EU would appreciate it s comments being taken into 
consideration and invites China to notify the draft regulations to the WTO.  
2.114.   In response, the delegation of China  provided the following statement. The Revised 
Regulations on the Administration of Commercial Cryptography are list ed in the Legislative Work 
Plan of the State Council for 2021. The revision of the Regulations will follow law -based, democratic, 
and scientific principles. And the process of the revision will be open, transparent, and ensure that 
all the stakeholders par ticipate in the revision through legal channels.  
 
32 For previous statements follow the thread under ID 644 . G/TBT/M/87  
 
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  2.1.3.11   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 , 
G/TBT/N/MEX/465/Rev.1  (ID 67833) 
2.115.   The delegation of the United States  provided the following statement. The United States 
remains highly concerned with the revised measure and submitted comments to Mexico's Enquiry 
Point on 3 May 2022. We encourage Mexico to revisit and address discriminatory practices towards 
imports, such  as lot -by-lot and increased testing for imported products. Could Mexico please provide 
an update on the status of this measure? The United States requests that Mexico consider allowing 
fatty acid analysis to be voluntary rather than mandatory. Currently, there are no internationally 
well-accepted biomarkers to differentiate milk fat from all vegetable fat. Additionally, there are no 
relevant Codex or other international standards available for this type of analysis. The United States 
is concerned this meas ure may conflict with the ongoing redrafting of the corresponding cheese 
standard. How will Mexico harmonize the 2019 update to the NOM -223 cheese standard, with the 
NOM-223 cheese CAP versions developed through 2020 –2021, and an expected 2022 update to th e 
NOM-223 cheese standard? Once finalized, will implementation of the measure move forward based 
on Mexico's Quality Infrastructure Law or the law it replaced, the Federal Law on Metrology and 
Standardization?  
2.116.   Could Mexico provide clarification on the diff erent roles that each Ministry will play in the 
monitoring, compliance, and verification activities listed in the draft measure? If Mexico proceeds 
with implementation of the current measure, the United States (Government and industry) would 
need at least one year to launch compliance systems. The United States urges Mexico to indefinitely 
delay implementation of the measure and consider less trade -restrictive alternatives as previously 
proposed by the US Government, other WTO members, and industry stakehol ders. 
2.117.   The delegation of Australia  provided the following statement. Australia would like to thank 
Mexico for providing Members with the opportunity to comment on G/TBT/N/MEX/465/Rev.1 . We 
look forward to receiving Mexico's reply to our comments on its notification. Aust ralia would like to 
reiterate its concerns that Mexico's measure notified as G/TBT/N/MEX/465  appears discriminatory 
and more trade restrictive than necessary and have made further comments on the revised 
notification. Australia recognizes the original objectives of the proposed measures and welcomes the 
review of the procedure in light of Mexico' s international commitments. We kindly request an update 
for the release date of the new version of the procedure for public consultation.  
2.118.   The delegation of New Zealand  provided the following statement. New Zealand welcomes 
the opportunity to speak in supp ort of this specific trade concern raised by the United States. New 
Zealand considers that the conformity assessment procedures that Mexico has set for cheese under 
NOM 223 are more trade restrictive than necessary, with some aspects of the procedure likel y to 
cause difficulties for New Zealand exporters and creating unnecessary obstacles to international 
trade. We thank Mexico for its notification of these measures and look forward to receiving a 
response from Mexico on our comments.  
2.119.   The delegation of the European Union  provided the following statement. The European Union 
would like to join this trade concern and refer to the written comments on the revised text notified 
on 8 February that were sent to Mexico on 22 April 2022. According to information from EU industry, 
some aspects of the conformity assessment procedure (CAP) for the Mexican Official Standard NOM -
223-SCFI/SAGARPA -2018 on cheese may cause difficulties for EU exporters. The EU would 
appreciate a reply to the written comments and would like to ask about the state of play of the 
ongoing revision of the measure.  
2.120.   In response, the delegation of Mexico  provided the following statement. As mentioned in the 
meeting of the Committee on Technical Barriers to Trade on 10  March, Mexico notified a new versi on 
of its Conformity Assessment Procedure on 8  February, in document  G/TBT/N/MEX/465/Rev.1, with 
a deadline for submitting comments of 9  April. The delegations of the European Union and the United 
States nevertheless requested an extension of the deadline to submit their comments to 30  April 
and 9  May, respectively. This extension was granted.  
 
33 For previous statements follow the thread under ID 678 . G/TBT/M/87  
 
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  2.121.   The comments received during the additional public consultation period are currently being 
evaluated by the competent standardizing authorities. Mexico reaffirms its commitment to 
transparency. Any updates will be duty shared and notified in a timely manner.  
2.1.3.12   European Union - Draft EU Batteries Regulation (implementation of the 
European Green Deal), G/TBT/N/EU/775  (ID 68534) 
2.122.   The delegation of China  provided the following statement. First I would l ike to thank the EU 
for their feedback on our concerns at the last Committee meeting. Unfortunately, we think the replies 
given by the EU neither solved our concerns nor responded to our specific suggestions on the draft 
EU batteries regulation. Hence, I w ould like to refer to our suggestions raised at the last meeting 
and wish the EU can give a concrete response to our suggestions. In addition to the suggestions we 
made at the previous meeting, I would like to add three additional suggestions as follows. 1. 
Regarding Article 8 of recycled content, it is suggested that the subsidiary of recycled content could 
be notified to WTO Members with a comment period of at least 60 days. Meanwhile, the data access 
requirements related to the proportion of recycled con tents shall be notified to the WTO. 2. 
Regarding Article 13 and Annex, it is recommended that the time of label replacement for products 
that are placed on the market could be set in a flexible way, for example, the labels could be replaced 
batch by batch.  The label replacement of products that are placed on the market may involve recall 
and disassembly, so it is recommended to set a more flexible way for label replacement of products. 
3. With regard to the registration and extended responsibility of manufa cturers in articles 46 and 
47, it is suggested to allow producers to submit an application for registration in only one Member 
state rather than in each Member state.  We would encourage the EU to consider establishing a 
regulatory system where producers co uld have extended producer responsibility one time and select 
the specific market where the batteries are available.  
2.123.   The delegation of the Republic of Korea  provided the following statement. Korea appreciates 
this opportunity to make comments on the recent ly published "Proposal for a Regulation of the 
European Parliament and of the Council concerning batteries and waste batteries" of the European 
Union. First of all, The Korean government fully respects and supports the efforts of the European 
Parliament an d the Council to provide information to consumers and protect the environment. 
Furthermore, Korean companies are making efforts to faithfully comply with the regulation of the 
EU. However, in relation to the battery replacement requirements specified in Ar ticle 11 of the 
amendment published in March 2022, the Korean industry has difficulties regarding who and how to 
replace batteries, and the availability of batteries as spare parts. So we would like to deliver the 
following requests.  
2.124.   First, the amendment s tipulates that batteries shall be removable and replaceable by the 
end-user. However, if inexperienced end -users replace batteries of some electronic products that 
require professional knowledge or skills about disassembly and reassembly when replacing int ernal 
parts, it will be difficult to ensure user safety and fulfill product specifications, leading to product 
liability issues. Therefore, we request that the EU add "independent operators" to the relevant 
provision and specify the person to replace batte ries as the end -user or independent operators. 
Second, we request that the EU allow the use of commercially available tools (including thermal 
energy, solvents, and specialized tools) when replacing batteries. The amendment practically 
prevents the use of thermal energy, solvents, and specialized tools. However, since the use of 
adhesives is essential to guarantee the product's waterproofness, durability, and ease of assembly, 
battery replacement using commercially available tools, including thermal energy,  must be allowed 
to guarantee the Rights to Repair. Third, Korea requests that the EU improve the amendment by 
deleting the ten -year mandatory supply period of battery components. Retaining batteries as spare 
parts for ten years would reduce resource effic iency and increase waste generation due to unused 
and oversupplied battery parts, making the requirement conflict with the ecodesign regulatory 
objectives. Lastly, we request that the EU make an exception for equipment which is made compactly 
for portabili ty from the requirement to ensure battery replaceability. For some products that are 
small or waterproof, the battery cannot be replaced due to their sealing structures. Keeping the 
battery replaceability obligation can compromise the manufacturer's opport unity in developing 
designs or types for products such as wireless earphones, ring -shaped wearables, etc.  
2.125.   The delegation of the Russian Federation  provided the following statement. The Russian 
Federation reiterates the statements made during the previous m eetings of the TBT Committee with 
 
34 For previous statements follow the thread under ID 685 . G/TBT/M/87  
 
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  regard to the proposal for a regulation of the European Parliament and of the Council concerning 
batteries and waste batteries. We appreciate efforts of the EU in the fields of fighting climate change 
and protection of env ironment, however we are concerned with the lack of scientific data and 
international standards as a basis for proposed conditions for access to the European Union market 
as well as material recovery targets for waste batteries. The policy currently carrie d out by the 
European Union as a whole cannot but lead to the global imbalance in trade in basic raw materials 
including non -ferrous metals. This policy causes soaring prices along the entire supply chain 
provoking crisis and inflation while hampering the already unsustainable global trade architecture. 
We urge the EU to conduct its trade -related climate policy in compliance with the WTO rules and 
relevant climate agreements without creating obstacles to trade and preserve a sufficient level of 
competition between imports and domestic manufactures.  
2.126.   In response, the delegation of the European Union  provided the following statement. The EU 
would like to recall that the Batteries Regulation proposal was presented on 10 December 2020 and 
notified to the WTO on 2 6 January 2021 with a commenting period of 90 days. During the 
commenting period, the EU received written comments from China, Japan and Canada to which the 
EU replied on 18 October 2021. The EU would like to remind that batteries are an important source 
of energy and one of the key enablers for sustainable 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 
sustainable manner. The EU has taken good note of the points raised by delegations.  
2.127.   The EU would like to reassure that there will be sufficient time to consider the feedback 
received on the notified draft prior to adopt ion. Implementing and delegated acts that will be 
developed under the notified draft will involve consultation of stakeholders, though the exact way in 
which this will be done is to be determined in each case. Drafts of those implementing measures 
and dele gated acts will be notified to the WTO in accordance with the TBT Agreement. The application 
dates for some of the provisions in the notified draft 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 the notified draft. In fact, it is clear that at least some of 
the applic ation dates need to be reassessed, because the regulatory process is still ongoing. The 
European Parliament and the Council have concluded their respective positions in March this year. 
The issues raised by the delegation of the Republic of Korea concern a mendments by the European 
Parliament. These amendments are being considered in the negotiations between the European 
Parliament and the Council to decide on the final Regulation. The aim is to conclude this process in 
the second half of this year. The EU h as taken good note of the comments from the Republic of 
Korea.  
2.128.   In conclusion, the EU stresses that the notified draft seeks to fulfil multiple, interlinked 
objectives including the protection of the environment and human health and safety, all of which are  
legitimate policy objectives under Article 2.2 of the TBT Agreement. For the reasons specified above, 
the EU considers that the notified draft is not more trade restrictive than necessary to fulfil these 
legitimate policy objectives, taking into account t he risks that non -fulfilment would create. Regarding 
Article 2.1 of the TBT Agreement, the EU does not consider that the notified measure gives rise to a 
risk of discrimination within the meaning of that provision. The notified draft therefore fully compli es 
with the provisions of the TBT Agreement.  
2.1.3.13   European Union - Chemical strategy for sustainability (implementation of the 
European Green Deal) (ID 69035) 
2.129.   The delegation of the Russian Federation  provided the following statement. Russian 
Federation reiterat es the statements made during the previous meeting of the WTO working bodies 
and expresses the concern on the chemical strategy developed by the European Union as an element 
of implementation of the European Green Deal. The document implies potential restr iction and even 
prohibition of materials that classified as hazardous regardless of whether sufficient scientific basis 
for this has been provided or not. We note that the core legal act for classification of chemicals and 
substances of the EU is the CLP R egulation. Currently, this regulation allows to make strict 
classification decisions without sufficient scientific data in accordance with the precautionary 
principle. One recent example of this practice is cobalt classification under the 14th ATP to the E U 
 
35 For previous statements follow the thread under ID 690 . G/TBT/M/87  
 
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  CLP Regulation. Such an approach can lead to unjustifiable prohibition of essential materials. We 
urge the EU to implement the strategy in full compliance with the WTO rules and principles.  
2.1.3.14   Egypt – Halal Certification Measure, based on Egyptian Standard ES 4249/2014 
General Requirements for Halal Food According to Islamic Sharia, G/TBT/N/EGY/313 , 
G/TBT/N/EGY/313/Add.1 , G/TBT/N/EGY/313/Add.2  (ID 71836) 
2.130.   The delegation of Canada  provided the following statement. Canada joins the United States, 
the European Union and other intervening Members to raise its contin ued concerns with Egypt's new 
halal certification requirements for all imported food and beverage products. Canada understands 
Egypt's objective to ensure that Egyptian consumers are confident that they are buying and 
consuming halal-certified products in agreement with Islamic Sharia. However, we also believe that 
such measures should not create unnecessary barriers to international trade or be more trade -
restrictive than necessary to fulfil that objective. While Canada appreciates Egypt notifying this 
measure to the WTO TBT Committee in December 2021, it failed to do so prior to the implementation 
date of 1 October 2021. As set out in Article 2.9 of the TBT Agreement, Members have an obligation 
to provide trading partners with adequate time to comment on a  given measure (at least 60 days) 
and have those comments taken into consideration prior to that measure being finalized.  
2.131.   In addition, as per WTO obligations, a six -month period between the notification of the final 
measure and its entry into force is cons idered a reasonable amount of time to provide industry time 
to adapt to the new requirements. This was clearly not the case with this measure. Although Canada 
appreciates Egypt's delayed implementation of the halal certification for dairy products to Octob er 
2022, Canada still remains concerned with the lack of details, documentation and specificity on how 
these requirements will be implemented and how specific products will be impacted. For example, 
the proposed new regime only specifies one Egyptian certi fication body that will have the authority 
to certify halal products for the Egyptian market. It is our understanding that this has already 
significantly raised the halal certification fee which will have to be borne by exporters of halal product 
to Egypt.  The new measure could result in a certification process that is overly burdensome, costly 
and more trade restrictive than necessary to achieve Egypt's stated objective. Canada strongly 
encourages Egypt to have open and transparent discussions with trading  partners to share 
information, further clarify the requirements under this new measure and consider the impact it may 
have on trade. Until then, we respectfully request that Egypt suspend the implementation of the 
measure. Canada also notes Egypt did not provide a written response to Members at previous TBT 
Committee meetings and kindly asks Egypt to provide one to Members for this meeting.  
2.132.   The delegation of the European Union  provided the following statement. The European Union 
would like to express concerns with regard to the requirements on halal certification as of 1 October 
2021 based on the Egyptian halal standard 4249/2014. The EU industry is worried about the negative 
impact of this measure on food and beverages imports to Egypt. The EU regrets that Egypt notified 
to the TBT Committee the requirements for the importation of meat, poultry and their products, milk 
and dairy products only on 1 December 2021, after their ent ry into force for milk and dairy products 
on 1 October 2021, and that the notification did not include the text of the measure. The EU recalls 
that, according to Article 2.9.4 of the WTO TBT Agreement, Members shall allow a reasonable time 
(at least 60 day s) for other Members to submit written comments on their draft measures, so that 
comments can be taken into account. In any case, the EU submitted written comments on 26 January 
2022 and would welcome a reply by the Egyptian authorities. The EU understands  that the rules on 
halal certification are in drafting process and invites Egypt to notify them to the TBT Committee, 
when still in draft form, so that comments can be provided. We would welcome any updated 
information as regards the scope and the implemen tation method of these rules.  
2.133.   We welcome some of the steps envisaged to mitigate the negative impact of the measures, 
such as the grace period until 15 December 2021 during which, certification by "IS EG Halal " was 
voluntary and for free or the acceptance of imports of milk and dairy products without a halal 
certificate until 28 February 2022 and the exclusion of crude milk from a halal certificate, both 
notified in Addendum 1 of 7 January 2022. We welcome as well the more recent facilitating measures 
notified to the TBT Committee on 4 April 2022 extending, until 30 September 2022, the period in 
which imports of milk and dairy products are accepted in Egypt without a halal certificate. 
Nevertheless, some of those facilitation measures are only temporary and affected companies need 
sufficient time to adapt to the new certification and labelling requirements. Therefore, the EU would 
 
36 For previous statements follow the thread under ID 718 . G/TBT/M/87  
 
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  urge Egypt to postpone the implementation of this measure and to provide for a reasonable 
adaptation period of at least one year b etween the publication of the measures - updated rules on 
halal certification and labelling requirements - and their entry into force, in accordance with 
Article  2.12 of the TBT Agreement. The EU would like to invite Egypt to reconsider the decision to 
grant the right to certify the compliance with halal requirements to a single company, IS EG Halal, 
and to provide for a halal certification system that would allow multiple, well -established certification 
entities, in accordance with the international best p ractices. Re -certification by IS EG Halal of 
products from establishments already certified by other companies would lead to longer time to 
market and higher costs for consumers, while Egypt is suffering food security problems, aggravated 
by the coronaviru s pandemic. The EU would welcome clarification on whether multiple halal 
certification entities, including from third countries, would continue to be allowed for imports, as it 
is understood from point 6 of the original TBT notification form.  
2.134.   The EU would like to ask Egypt to consider keeping the halal certification and labelling 
voluntary, in order to pursue the legitimate objective of ensuring reliable information without unduly 
hindering trade flows. Consumers should be able to decide whether to buy hala l-certified food or 
not, based on clear labelling. The EU would appreciate if Egypt would consider further trade 
facilitating measures, such as requiring halal certification for the product and not per container, as 
well as proportional costs of halal cert ification that take into account the international practice and 
correspond to the service rendered. The EU understands that the new requirements on halal 
certification will certify the compliance with Egyptian standard ES 4249/2014 on General 
requirements for "halal" food products in accordance with the provisions of Islamic Sharia. According 
to the available information in the TBT notification form G/TBT/N/EGY/313 , this standard is under 
revision and will be notified to the WTO TBT Committee. The EU would like to thank Egypt for th e 
updated version of standard ES 4249/2014 shared in February 2022, ask about the status of the 
revision and invite Egypt to notify it to the TBT Committee. The EU provided comments on the draft 
updated halal standards via the EU delegation  in Cairo and wo uld appreciate they are taken into 
consideration. Finally, the EU would like to ask Egypt about the concrete steps envisaged to provide 
comprehensive information about the new measures and clear written and publicly available 
guidance to stakeholders, incl uding a detailed description of the certification procedure, its duration, 
costs, and required documents, as well as the process for registration of suppliers, and the product 
coverage (with HS codes). The EU would also like to know whether halal certifica tes will be required 
for products that are not 100% milk, but which contain milk or milk ingredients amongst others. The 
EU is ready to work with Egypt on solutions that would prevent the negative impact this measure 
would have on food and beverages import s to Egypt.  
2.135.   The delegation of the United States  provided the following statement. The United States 
continues to recognize Egypt's right to provide its consumers assurance with regard to the halal 
status of certain products. However, the manner in which Egypt has implemented and notified new 
requiremen ts may be more trade restrictive than necessary. From the original notification 
(G/TBT/N/EGY/313 ) through the latest ( G/TBT/N/EGY/313/Add.2 ), Egypt has failed to provide a 
clear, consistent explanation of the changes to its halal certification import requirements. While 
Egypt appears to be imple menting changes to the import requirements for halal -certified products, 
these changes have not been notified and published in a transparent manner. This lack of consistent, 
predictable, and transparent requirements has substantially impacted US exports, e specially in the 
dairy sector. While Egypt announced a delay in implementation until 30 September 2022, US 
exporters will still be unable to comply with Egyptian import regulations without duly notified 
technical standards or implementing regulations.  
2.136.   The United States notes that this notification should clearly delineate the scope of affected 
products, contain technical halal standards for any new product that will be required to be certified 
halal as a condition of import, and contain other implementing r egulations that address fee 
schedules, audit procedures, labelling requirements, and export registration requirements. The 
United States also requests that Egypt explain its current process for approving overseas halal 
certification bodies. The United Stat es notes that Egypt is changing its requirements around which 
certification bodies are approved to provide halal certification. These changes should also be notified 
in written implementing measures, with clear requirements for approving or disapproving ov erseas 
certification bodies. The United States reiterates its request for Egypt to delay implementation and 
enforcement of new halal requirements until Egypt notifies all draft implementing measures of any 
new halal requirements, and after interested parti es have had an opportunity to submit written 
comments through the WTO TBT Enquiry Point, discuss these comments upon request, and have 
these comments taken into account in drafting final measures.  G/TBT/M/87  
 
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  2.137.   The delegation of Australia  provided the following statemen t. Australia thanks Egypt for 
ongoing bilateral communication and engagement on the implementation of new halal certification 
requirements for IS EG Halal. We welcome Egypt's notification of details around these new 
requirements to the TBT Committee on 1 D ecember 2021 via G/TBT/N/E GY/313 , to which Australia 
provided comments. We would appreciate Egypt's consideration of and response to these comments. 
We further welcome the advice received bilaterally that Egypt intends to notify further changes to 
product scope for IS EG Halal cert ification requirements, and that implementation will only occur 
after Members have been provided an opportunity to comment and for those comments to be 
considered. Australia welcomes ongoing discussion on the implementation of Egypt's new halal 
certificati on measures to ensure they meet Egypt's policy objectives while also ensuring measures 
are not more trade restrictive than necessary.  
2.138.   The delegation of Paraguay  provided the following statement. Paraguay thanks the 
delegations of Canada, the European Union  and the United States for including this item on the 
Committee's agenda. We find it regrettable to have to continue to support this concern in this and 
other forums, most recently at the meeting of the Council for Trade in Goods. However, despite 
repeated  submissions, we still do not have the information that we requested. While Paraguay shares 
Egypt's concern that consumers be provided with certainty regarding the purchase and consumption 
of halal certified products, not having precise information on the scope of the measure or details of 
its implementation prevents operators from being able to adapt to comply with it. Paraguay again 
requests that Egypt suspend the implementation of the new halal certification requirements until 
Members have all the inform ation requested and trade operators have had enough time to adapt in 
order to ensure their compliance.  
2.139.   The delegation of Switzerland  provided the following statement. Switzerland is following this 
matter with interest and supports the concerns expressed by  other Members with regard to the 
requirements on halal certification based on the Egyptian halal standard 4249/2014. We are 
concerned over the potential negative impact of these measures on bilateral trade.  While Switzerland 
recognizes Egypt's legitimate objective of providing consumers with reliable information on the halal 
integrity of certain products, we expect Egypt to fully comply with its WTO obligations. We believe 
that such measures should not be more trade restrictive than necessary to ensure leg itimate 
objectives are met. In this respect, we call on Egypt to provide flexibility for the continued recognition 
of foreign halal certification bodies and the acceptance of foreign halal certificates. Furthermore, we 
stress the importance of providing a reasonable period of time to allow industry to adapt to the new 
certification and labelling requirements. Switzerland encourages Egypt to consider less trade 
restrictive alternatives and additional trade facilitating measures.  Switzerland invites Egypt to 
comply with the notification obligations under the TBT Agreement and provide detailed information 
about the implementation of the new measure, including detailed description of the certification 
procedure, its duration and cost, as well as the product cove rage. 
2.140.   The delegation of New Zealand  provided the following statement. New Zealand welcomes 
the opportunity to speak in support of this trade concern raised by the United States, Canada and 
the EU. New Zealand refers to earlier statements made on the parall el issue at the Council on Trade 
in Goods. We understand that Egypt is has implemented changes under Prime Ministerial Decree 
(No. 35/2020) to require that certification of relevant halal standard(s) shall only be undertaken by 
IS EG Halal, and that certif ication from other halal certification bodies is no longer accepted for halal 
food products imported into Egypt. New Zealand also understands that the measures may apply to 
dairy products imported into Egypt, irrespective of whether halal labelling is appl ied to those goods, 
and irrespective of whether these goods have previously been treated as halal. New Zealand still 
has serious concerns with these measures. New Zealand would like to better understand what 
consideration Egypt has accorded to less trade r estrictive alternatives. We are also interested in 
what factors led Egypt to introduce a measure that requires halal certification of products, which 
have commonly been treated and accepted as intrinsically halal. We also understand that the 
certification process is straying into sanitary matters; both during audits or inspections and in respect 
of additional sanitary information being required for registration with IS EG Halal. Sanitary matters 
should remain out of scope for IS EG's Halal certification and  be addressed by Competent Authorities 
responsible for sanitary matters in line with existing agreements.  
2.141.   New Zealand would like to thank Egypt for the WTO notification G/TBT/N/EGY/313  dated 
1 December 2021. We understand that Egypt is currently developing a new halal standard whi ch will 
clarify which products are subject to halal certification and the standard applied. We look forward to 
this Halal Standard being provided and notified to the TBT Committee in accordance with G/TBT/M/87  
 
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  Article  5.6.2 of the TBT Agreement. New Zealand would lik e to thank Egypt for its ongoing bilateral 
engagement on this issue. We request Egypt provide clarification on the points made above and 
continue to request that any new measures be suspended until all WTO obligations, including those 
requiring consultatio n with other WTO Members, have been met.  
2.142.   The delegation of Chile provided the following statement. The delegation of Chile reiterates 
its previously stated concern, which was recently raised in this Committee. Chilean certification 
centres continue to work  on this issue in order to facilitate the trade with Egypt of products with 
halal certification requirements.  
2.143.   The delegation of Argentina  provided the following statement. Argentina reiterates its 
concern about this measure and the lack of detailed and com plete information on it. The recent 
postponement of the entry into force of the new regime does not allay concerns and worries about 
it. These concerns relate mainly to the lack of transparency and predictability, as there is no 
information on the certific ation procedures or other regulatory details. In this regard, we request 
Egypt to provide the necessary information and that the measure not be implemented until this 
detailed information is available.  
2.144.   In response, the delegation of Egypt  provided the foll owing statement. Egypt thanks Canada, 
the European Union, the United States, Australia, New Zealand, Paraguay, Switzerland, Argentina, 
Chile for raising this issue and their continued engagement on this matter recognizing Egypt's right 
to determine appropr iate halal certification requirements. Recognizing the comments that have been 
raised by our trading partners during the bilateral meetings and at the multilateral level, Egypt has 
taken a number of steps to take into account the concerns raised with respe ct to transparency and 
allowing for an appropriate period for implementation. In documents G/TBT/N/EGY/313  and 
G/TBT/N/EGY/313/ Add.1 , the product coverage and the timeline for entry into force have been 
clarified. Egypt has taken a number of facilitating measures including allowing imports of milk and 
dairy products that are not accompanied by a halal certificate to enter into Egy pt until 28 February 
2022, as acknowledged by our trading partners and this grace period has been extended until 
30 September 2022 .  
2.145.   Through its TBT Enquiry Point, Egypt has replied to the questions sent by the WTO Members 
and is currently preparing a new set of replies related to the follow -up and new questions that have 
been received. I would also like to refer to the statement made by Egypt during the last TBT 
Committee meeting as published in the minutes of the meeting. I would also like to note that ES  
4249 for 2014 is currently under review and will be duly notified to the WTO TBT Committee. Finally 
I would like to stress that Egypt is committed to continue its bilateral exchanges on the matter with 
all interested trading partners and to take into acco unt their concerns as appropriate and stress our 
commitment to the transparency commitments under the TBT Agreement.  
2.1.3.15   United States - Protecting Against National Security Threats to the 
Communications Supply Chain through the Equipment Authorization Program  and the 
Competitive Bidding Program, G/TBT/N/USA/1771  (ID 71437) 
2.146.   The delegation of China  provided the following statement. First I would like to thank the US 
for their feedback on our concerns at the last Committee meeting.  Unfortunately, the replies given 
by US did not respond  to our specific suggestions. Taking this opportunity, China would like to refer 
to our suggestions and wish US can give a concrete response to our suggestions as early as possible.  
1. For the new provision 47 CFR 2.903, it is recommended to revoke. The r easons are as follows: 
The added provision 47 CFR 2.903 prohibits the authorization of certain telecommunications 
equipment and services under provision 47 CFR 1.50002, but 47 CFR 1.50002 lists only five 
companies belonging to China, which violates WTO/ TB T non -discriminatory principles. In accordance 
with Article 2.1 of the TBT Agreement, Members shall ensure that in respect of technical regulations, 
products imported from the territory of any Member shall be accorded treatment no less favourable 
than that  accorded to like products of national origin and to like products originating in any other 
country, it is recommended to revoke this provision.  
2.147.   2. For Section III. A of the draft regulations, it is recommended to provide technical 
standards that judge th e national security threats, and that the FCC shall authorize the products 
that comply with the safety technical standards. The reasons are as follows: The draft regulations 
 
37 For previous statements follow the thread under ID 714 . G/TBT/M/87  
 
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  prohibit the authorization of certain telecommunications equipment and services un der provision 47 
CFR 1.50002, on account of national security threats. Without a public technical standard and 
measurement index, the fact that the United States deems products of Chinese enterprises to have 
security threats is violating the WTO/TBT transp arency principles. It is recommended to provide 
technical standards and measurement index and notify WTO members, moreover, to provide 
opportunities to other WTO Members to make comments. 3. For section III.A.3 of the draft 
regulations, it seeks comments o n whether to revoke any of the authorizations that have been 
previously granted for "covered " equipment on the Covered List(47 CFR 1.50002). it is proposed not 
to revoke the authorizations. The reasons are as follows: Currently, the equipment authorization s 
that have been previously granted are obtained strictly in accordance with the then -effective 
regulations, TCB -certified by the FCC, or SDOC process prescribed by the FCC. There is no violation 
of the situations mentioned in provision 2.939 of section II I.A.3.  
2.148.   In response, the delegation of the United States  provided the following statement. The 
United States notified the proposed rules, "Protecting Against National Security Threats to the 
Communications Supply Chain Through the Equipment Authorization Pr ogram and the Competitive 
Bidding Program, " to the WTO on 3 September 2021. This action is a Notice of Proposed Rulemaking 
(NPRM) (ET Docket No. 21 -232) by the United States Federal Communications Commission (FCC), 
adopted on 17 June 2021, in which the FCC  proposes to revise rules related to its equipment 
authorization processes to prohibit authorization of any "covered" equipment on the recently 
established Covered List, included in PUBLIC LAW 116 –124 Secure and Trusted Communications 
Networks Act of 2019,  enacted by U.S. Congress 12 March 2020. The FCC accepted formal comments 
on the Equipment Authorization Notice of Proposed Rulemaking until 18 October 2021, and China's 
comments were submitted on 18 September 2021. In total, the FCC has received nearly 25 0 
comments, including from China. All of the comments are available to the public and can be found 
on the FCC's website. United States appreciates China for its comments. The final rule will include 
information on all substantive comments received, and how  the comments were taken into account. 
Information on any rule changes will be notified to the WTO as an addendum to the original 
notification. The final rule has not yet been issued so when we issue the final rule in the Federal 
Register we publicly addre ss all substantive comments received, publicly, so that is how we would 
submit to China any concerns and we are happy to send the website when the measure is final.  
2.1.3.16   Belgium - Draft law introducing additional security measures for the provision 
of mobile 5G  services, G/TBT/N/BEL/44 , G/TBT/N/BEL/45  (ID 71338) 
2.149.   The delegation of China  provided the following statement. China would like to thank the EU 
for the response given at the last Committee meeting. Regrettably, however, replies given have 
done little to resolve our concerns. So China would like to refer to our suggestions made last meeting 
and we would like to see more reasonable and practical settlement to the issue. China recognizes 
that WTO Members are legitimately entitled to protect the security of their 5G network. China hopes 
that our concerns shall be we ll addressed by the EU and Belgium. China welcomes any further 
responses and clarifications from the EU and Belgium and urges Belgium to promptly notify the 
revised royal decree. For the G/TBT/N/BEL/44 , we would like to raise concerns that: 1. With regard 
to point 1. A, "It is recomm ended to use objective and product -based technical standards for risk 
assessment ". China has two core concerns on this issue: the first one is that the risk assessment 
criteria shall be objective, i.e. the non -objective risk assessment criteria based on th e characteristics 
of vendors in the notified law, are inconsistent with the TBT Agreement, which provides that a 
technical regulation shall be an objectively definable standard based on the product characteristics; 
the second one is that relevant internati onal standards and good practices shall be used as the basis 
for the risk assessment criteria, specifically, Belgium shall comply with Article 2.4 of the TBT 
Agreement by using, in the notified law, internationally recognised technical standards that can 
objectively assess the product security or certification methods that are based on international 
standards as the sole or fundamental assessment criteria for product security.  
2.150.   A. The risk assessment criteria shall be objective. With respect to China's first  concern, the 
EU replied that the risk profile is assessed on the basis of the factors listed in the new Article 105, 
§5 subparagraph 4 of the adopted law and these factors come from the EU 5G Cybersecurity Toolbox. 
Because the EU 5G Cybersecurity Toolbox does not suffice to look at the quality of network elements 
and does include non -technical vulnerabilities, the notified law has taken into account the non -
technical assessment criteria to guarantee the supply of network elements. The EU's reply did not 
 
38 For previous statements follow the thread under ID 713 . G/TBT/M/87  
 
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  address China's core concern on this point. As a technical regulation notified under the TBT 
Agreement, the notified law should be consistent with the requirement under the TBT Agreement 
that a technical regulation or standard shall be objectively definable,  and whether it complies with 
the EU 5G Cybersecurity toolbox is irrelevant. The risk assessment criteria in the notified law does 
not contain any technical details. China reiterates that the non -objective risk assessment criteria 
based on the characterist ics of vendors in the notified law are inconsistent with requirements of the 
TBT Agreement for technical regulations and standards.  
2.151.   B. Relevant international standards and good practices shall be used as the basis for the risk 
assessment criteria. With res pect to China's second concern, the EU replied that, in practice, the 
BIPT "will refer to the most appropriate existing best practices and/or international standards in 
accordance the Article 2.4 of the TBT Agreement in its opinion to the ministers concern ing risk 
assessment "; and the reason that relevant international standards or best practices are not listed in 
the notified law is because not all aspects of 5G technology are covered by international standards 
or best practices, and that these instruments  are changing. The EU further mentioned that, as no 
relevant international standards or best practices currently exist as regards the non -technical 
assessment criteria, solely referring to existing international standards or best practice to evaluate 
the p erformance of the product would not be possible to effectively and appropriately fulfill the 
legitimate objective pursued by the notified law. The EU's reply still has yet to provide a reasonable 
explanation for not adopting relevant international standard s or good practices in the notified law.  
2.152.   First, non -technical risk assessment criteria do not conform with the TBT Agreement as 
regards the definitions of technical regulations or standards, and a lack of existing international 
standards or best practices for such criteria cannot justify Belgium's non -fulfillment of its obligation 
under the TBT Agreement to use relevant international standards as the basis for the technical 
regulations or standards. China has pointed out that the TBT Agreement requires that  technical 
regulations and standards should be objectively definable based on product characteristics. As 
recommended by China, there do exist international recognised technical standards or good practices 
that comply with the TBT Agreement and can objecti vely evaluate the product security. Accordingly, 
the EU's explanation cannot effectively address China's core concern for Belgium's not using 
objectively definable international standards or good practices in the notified law. Second, since the 
notified la w and relevant provisions are notified as technical regulation, Belgium is obliged under 
Article 2.4 of the TBT Agreement to use international standards based on technical criteria as a basis 
for such technical regulations. China would like to point out th at there are international standards 
based on technical criteria in the industry (e.g the Network Equipment Security Assurance Scheme 
(NESAS) and Security Assurance Specifications (SCAS) published by Global System for Mobile 
Communications Association (GSM A), the 3rd Generation Partnership Project (3GPP), the Common 
Criteria for Information Technology Security Evaluation, and the cybersecurity certification standards 
set out in EU's 5G cybersecurity certification scheme specified in Regulation (EU) 2019/881 ). 
Therefore, China urges that Belgium comply with Article 2.4 of the TBT Agreement by using, in the 
notified law, internationally recognised technical standards that can objectively assess the product 
security or certification methods that are based on in ternational standards as the sole or fundamental 
assessment criteria for product security.  
2.153.   2. With regard to point 1.C, "For Article 105, §4, al.1, it is recommended to specify the 
extent of prohibiting and restricting the HRVs and the procedures to revoke  the identification of 
HRV". China's core concern regarding this issue is that the notified law does not specify the scope 
and method through which the HRVs are prohibited or restricted, nor does it illustrate the legal basis 
and the detailed procedures to  seek removal of the HRV designation. The EU's replied that the Royal 
Decree notified by Notification G/TBT/N/BEL/45  (the "notified royal decree ") has already specified 
to what extent HRVs are prohibited or restricted; if HRVs want to challenge the HRV designation, 
they can appeal ag ainst the final decision of the Ministers before the Council of State. The EU's reply 
on this issue still did not address China's core concern. With respect to the extent HRVs are prohibited 
or restricted, the notified royal decree generally prohibits the use of any active elements produced 
by "high-risk equipment manufacturer " in specific types of networks, and does not specify how such 
5G equipment or its parts are classified for their different security levels based on their different 
product security an d actual risks. With respect to the removal of the HRV designation, the notified 
royal decree and related regulations only allows 5G MNOs to defend against the preliminary results 
of the risk assessment and to request a hearing, and do not provide legal re medies directly to those 
identified as "high-risk equipment manufacturers ". In this regard, the so called "high-risk equipment 
manufacturers " are hindered from effectively seeking remedies provided to them under other 
Belgium laws and regulations when they are not fully informed of the reasons for the designation G/TBT/M/87  
 
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  nor have any change to present facts or arguments in support of their positions be fore the competent 
authorities making such designation. Moreover, the notified royal decree does not illustrate the legal 
basis and the detailed procedures to prohibit or restrict the high -risk equipment manufacturer or to 
seek removal of the "high-risk eq uipment manufacturer " designation. As mentioned before, it 
appears to be inconsistent with the requirement for the competent authority to administrate trade -
related laws and regulations in a uniform, fair and reasonable manner and may constitute de facto 
discrimination against specific 5G equipment vendors.  
2.154.   China reiterates that the notified law shall adopt an objectively definable security standard 
based on the product characteristics, rather than the non -objective risk assessment criteria based 
on the cha racteristics of vendors, and the relevant laws and regulations or technical standards shall 
be prepared, adopted or applied in a manner commensurate to the intended legitimate objectives, 
and not with a view or with the effect of creating unnecessary obsta cles to international trade. China 
recommends that Belgium further clarify in the notified law the specific scope, legal basis and 
procedures for prohibiting and restricting the HRVs from supplying 5G equipment or services, apply 
requirements of proportion ality and necessity to products of different security levels, and specify the 
path for so -called HRVs to seek removal of its HRV designation with detailed procedural guidance. 
3. With regard to point 1.D, "For Article 105, §4, al.4, it is recommended to ad opt fact -based, 
objective and fair risk assessment criteria ". China's core concern on this issue is that the risk 
assessment criteria are discriminatory and vague, lacking objectivity and impartiality. The EU replied 
that, the notified risk assessment crit eria, especially the factor of "the likelihood of the supplier being 
subjection to interference from a non -EU country " are justified and explained in the explanatory 
memorandum to the adopted notified law. The EU's reply has still yet to address China's co re 
concern. China recognises that WTO Members protect the security of their 5G network on the basis 
of objective facts and evidence, and in a manner consistent with the principles of fairness, non -
discrimination and transparency. However, the criterion in the notified draft as regards the extent 
of interference to the vendor by a non -EU country constitutes a de jure and de facto discrimination 
based upon the origin of vendors and discriminates the vendors from non -EU countries. Moreover, 
the explanation in the explanatory memorandum further indicates that the risk assessment criteria 
set out in Article 105, §4, al. 4 of the notified law are discriminatory and vague, lacking objectivity 
and impartiality. For instance, the explanatory memorandum mentions that the term "interference " 
should be read in the widest possible meaning and not merely in the sense of intelligence and 
security services.  
2.155.   China reiterates that laws, regulations and technical standards with regards to cybersecurity 
shall by no means constit ute unjustifiable discrimination or disguised restrictions on international 
trade; the 5G equipment security shall be assessed based on facts and industry -recognised objective 
security standards instead of a non -objective risk assessment of the vendors. Ch ina urges that 
Belgium comply with Article 2.1 and 2.2 of the TBT Agreement and other WTO requirements by 
developing objective, fair and non -discriminatory 5G equipment security standards and measures, 
taking full consideration of the characteristics and u sage of 5G technology and adopting existing 
industrial good practices. 4. With regard to point 2, "For Article 105, §5, it is recommended to 
provide so -called HRVs with rationales of the assessment and with reasonable remedies ". China's 
core concern regar ding this issue is that the notified law only allows 5G MNOs to defend against the 
preliminary results of the risk assessment and to request a hearing. However, the vendors of 5G 
equipment or services identified as the so -called HRV are not provided with a ny legal remedies. In 
response, the EU referred to its previous reply that remedies for HRV identification are provided in 
Article 105, §5 of the notified law, and further replied that HRVs are able to initiate appeals against 
the final decision of the Min isters in accordance with the first sentence of Article 19 of coordinated 
Acts on the Council of State.  
2.156.   The EU's reply did indicate that HRVs are entitled to appeal against the relevant Ministers' 
decision of refusing to lift the HRV designation. However, the EU did not specify whether HRVs have 
the right to defend against the preliminary results of the risk assessment and to request a hearing 
as provided for 5G MNOs in the notified royal decree and relevant provisions. Given that it is the 
vendors of 5G eq uipment or services that are subject to the risk assessment, China proposes that 
Belgium specify the administrative or judicial remedies for the vendors of 5G equipment or services 
in the notified law, require the competent authority to provide so -called H RVs with rationales and 
evidence of its decision, and grant vendors the right to defend themselves against unfavourable risk 
assessment decisions. For the BEL/45, we would like to raise concerns that: 1. China urges Belgium 
to promptly notify the revised r oyal decree in accordance with the requirements of Article 2.9.2 and 
other provisions of the Agreement on Technical Barriers to Trade. 2. The royal decree as well as G/TBT/M/87  
 
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  relevant laws, regulations and technical standards shall be provided and applied on the ba sis of 
objective facts and evidence, in a manner consistent with the principles of fairness, non -
discrimination and transparency and shall by no means constitute unjustifiable discrimination or 
disguised restrictions on international trade. Taking Chapter 2 of the notified royal decree as an 
example, such Chapter prohibits or restricts the 5G mobile network operators from using active 
elements produced by "high-risk equipment manufacturer " without specific standards or criteria. 
China would like to point ou t that there are international standards based on technical criteria in the 
industry (e.g. the Network Equipment Security Assurance Scheme (NESAS) and Security Assurance 
Specifications (SCAS) published by Global System for Mobile Communications Association  (GSMA) 
and the 3rd Generation Partnership Project (3GPP), the Common Criteria for Information Technology 
Security Evaluation, and the cybersecurity certification standards set out in EU's 5G cybersecurity 
certification scheme specified in Regulation (EU) 2019/881). Therefore, China suggests the adoption 
of internationally recognised technical standards that can objectively assess the product security or 
certification methods that are based on international standards as the sole or fundamental 
assessment cr iteria for product security, rather than the non -objective risk assessment criteria based 
on the characteristics of vendors.  
2.157.   3. Any party affected by relevant laws, regulations and technical standards shall be entitled 
to sufficient remedies. The notified royal decree and the relevant law only allow 5G mobile network 
operators to defend themselves against the preliminary results of the risk assessment and to request 
a hearing. However, it does not directly provide any legal remedies for 5G equipment manufac turers 
identified as so -called "high-risk equipment manufacturers ". In this regard, the so called "high-risk 
equipment manufacturers " are hindered from effectively seeking remedies provided to them under 
other Belgium laws and regulations when they are not  fully informed of the reasons for the 
designation nor have any change to present facts or arguments in support of their positions before 
the competent authorities making such designation. Moreover, the notified royal decree does not 
illustrate the legal b asis and procedure to lift the HRV designation. China proposes that Belgium 
specify the administrative or judicial remedies for 5G equipment manufacturers in the notified royal 
decree, require the competent authority to provide rationales and evidence of i ts decision, and grant 
the 5G equipment manufacturers the right to defend themselves against unfavourable risk 
assessment decisions and provide for detailed procedures to remove a high -risk designation, 
ensuring that the 5G equipment manufacturer identifie d as so -called HRVs is entitled to apply for 
removal of the designation.  
2.158.   4. The royal decree and relevant laws, regulations or technical standards shall be prepared, 
adopted or applied in a manner commensurate to the intended legitimate objectives, and not with a 
view or with the effect of creating unnecessary obstacles to inte rnational trade. Furthermore, they 
shall not be more trade -restrictive than necessary to fulfill their legitimate objectives. The notified 
royal decree generally prohibits the use of any active elements produced by "high-risk equipment 
manufacturer " in spe cific types of networks, and does not specify how such 5G equipment or its 
parts are classified for their different security levels based on their different product security and 
actual risks. China considers that different security levels can be applied on  the basis of product 
characteristics and objectively definable product security assessment standards in order to achieve 
the aforementioned requirements of proportionality and necessity.  
2.159.   In response, the delegation of the European Union  provided the follo wing statement. The 
European Union (EU) would like to thank the Chinese authorities for their additional comments on 
(i) the draft "Law introducing additional security measures for the provision of mobile 5G Services" 
and (ii) the draft "Royal Decree for t he secured rollout of 5G", notified by Belgium to the WTO 
respectively under references G/TBT/N/BEL/44  and G/TBT/N/BEL/45 . The EU regrets that China did 
not make its statement on this trade concern available on e -Agenda ahead of this meeting. The EU 
will address nevertheless the main concerns expressed therein.  The EU would like to clarify that the 
notified draft (hereinafter "the adopted law ") under G/TBT/N/BEL/44  was adopted on 10 February 
2022 and that no revision of the adopted law is foreseen in the near future. Moreover, the notified 
draft under G/TBT/N/BEL/45  has been substantially revised and will be translat ed into two new Royal 
Decrees. Both drafts were notified in early June under Directive (EU) 2015/1535 and are currently 
following the mandatory standstill procedure prescribed therein. As previously indicated, these two 
new Royal Decrees related to the law  notified under reference G/TBT/N/BEL/44  will then be notified 
in due course under the WTO TBT Agreement with a new commenting period in line with the TBT 
Committee recommendations. Taking this into consideration, the EU would like to provide the 
following general reply to the additi onal comments submitted by China under G/TBT/N/BEL/44 . G/TBT/M/87  
 
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  2.160.   With regard to point 1.A, "It is recommended to use objective and product -based technical 
standards for risk assessment ". First, all the criteria on the basis of which a supplier's risk profile is 
assessed originate from the NIS Cooperation Group's 5G toolbox39, except for the following 
"subfactor", please see the new Article 105, § 4, 1°, (e) of the adopted law: "e) the country the 
supplier originates from conducts or is involved in an offensive cyber policy ". The 5G toolbox incl udes 
non-technical vulnerabilities as the broader context in which the network elements are manufactured 
and delivered should also be considered. It does indeed not suffice to look at the quality of network 
elements. That is why the adopted law focuses not  only on the product's terms of performance but 
also takes account of whether the supply of those elements can be guaranteed. Currently, no 
relevant best practices and/or international standards exist as regards this criteria. Therefore, solely 
referring t o existing international standards to evaluate the performance of the product would be an 
ineffective and inappropriate means to fulfil the legitimate objective pursued. Furthermore, no 
provision in the TBT Agreement states that a technical rule must neces sarily and solely focus on the 
purely technical aspects of the product in order to be seen as objectively definable. The objective 
aspect of a technical rule is rather defined by its intended purpose and its proportionality to that 
purpose as Article 2.2 o f the TBT Agreement states: "Members shall ensure that technical regulations 
are not prepared, adopted or applied with a view to or with the effect of creating unnecessary 
obstacles to international trade. For this purpose, technical regulations shall not be more trade -
restrictive than necessary to fulfil a legitimate objective, taking account of the risks non -fulfilment 
would create. " 
2.161.   Second, the EU would like to clarify that the adopted law provides that nearly all elements 
of a 5G network are subject to a safety analysis as per the new Article 105, § 1. In this regard, the 
risk profile of the supplier of those elements plays an important role in the safety analysis. Finally, 
the risk profile is assessed on the basis of the factors listed in the new Articl e 105, § 4, subparagraph 
4 of the adopted law. Finally, in its opinion to the ministers concerned regarding the quality level, 
the Belgian telecom watchdog (BIPT) will refer to the most appropriate existing best practices and/or 
international standards in accordance with Article 2.4 of the TBT Agreement. As not all aspects of 
5G are covered by best practices or international standards and as in the course of time those 
instruments will be revised and replaced or completed by newer versions, it is not possib le nor 
opportune to give an exhaustive list of all those instruments in the adopted law. All technical details 
were included in one of the two new Royal Decrees (namely the one on ministerial authorization), 
as laws should be kept as simple as possible, co nsisting only of essential elements which are then 
further elaborated in a Royal Decree. It contains several referrals to ETSI -standards. ETSI is a 
recognized European standardization organization producing globally applicable standards for ICT -
enabled sys tems, applications and services. ETSI has over 900 members worldwide, from 65 
countries and 5 continents. ETSI -standards are well internationally recognized standards. The 
instruments to which China refers will be taken into account if and when the BIPT de ems it 
appropriate.  
2.162.   With regard to point 1.C, "For Article 105, §4, al.1, it is recommended to specify the extent 
of prohibiting and restricting the HRVs  and the procedures to revoke the identification of HRV ". China 
comments that the adopted law does not specify to what degree and in what way high risk vendors 
("HRV") are forbidden or restricted, nor whether and how the HRV designation can be revoked. The  
notified draft under G/TBT/ N/BEL/45  does specify to what degree and in what way HRVs are 
forbidden or restricted.40  Those restrictions are differentiated according to the various parts of a 5G 
network, hereby taking into account the different security levels of these parts of the 5 G network 
and of the products to be supplied. The use of active high -risk elements (so, elements for which the 
supplier is considered to be a high risk), for instance, is forbidden in certain parts, only restricted in 
other parts as far as non -sensitive ar eas are concerned. If a HRV wants to challenge their high -risk 
designation they must do so by way of written observations and/or during a hearing (which may be 
requested by the party applying for a ministerial authorisation and who may bring all legal and 
technical assistance he deems necessary, also including the so -called HRVs), and which would follow 
a refusal. A HRV may also appeal against this administrative legal act before the Council of State 
(see also the EU's response to the final question). The a dopted law and the notified draft under 
 
39 Please see CG Publication 01/2020, NIS Cooperation Group: "Cybersecurity of 5G networks EU 
Toolbox of risk mitigating measures", an online version in English is avai lable at:  
https://digital -strategy.ec.europa.eu/en/library/cybersecurity -5g-networks -eu-toolbox -risk-mitigating -
measures    
40 Please see Articles 2 -5 of the notified draft under G/TBT/N/BEL/45 . Please, however, note our 
explanations above that the notified draft under G/TBT/N/BEL/45  has been substantially revised and will be 
notified in accordance with the TBT Agreement as a revision with a new commenting period in due course.  G/TBT/M/87  
 
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  G/TBT/N/BEL/45  do not provide for any list of HRVs. Being designated in that capacity in one case 
does not automatically imply that the supplier will be considered high risk in another case and vice 
versa. The suppliers' risk profile is assesse d for each separate case.  
2.163.   With regard to point 1.D, "For Article 105, §4, al.4, it is recommended to adopt fact -based, 
objective and fair risk assessment criteria ". Regarding the determination of the supplier's risk profile, 
all criteria are objectively an d reasonably justified and explained in the explanatory memorandum 
to the adopted law. The EU refers to its response regarding point 1.A above. With regard to point 2, 
"For Article 105, §5, it is recommended to provide so -called HRVs with rationales of the  assessment 
and with reasonable remedies". As indicated in our previous reply, the criteria for identifying HRVs 
are provided in Article 105, § 4 of the adopted law and provide the basis of any assessment. As to 
remedies, a party requesting a ministerial a uthorisation will receive a draft decision and may make 
written observations and request a hearing for which he can bring all the legal and technical 
assistance he deems necessary (also including the so -called HRVs), as foreseen in Article 105, § 5, 
subpar agraph 2 of the adopted law. An appeal against the final decision of the Ministers can be 
lodged with the Council of State.41 The HRV is able to do initiate this appeal, since Article 19, first 
sentence of the coordinated Acts on the Council of State42 provides this can be done by any party 
who gives evidence of prejudice or of an interest. The possibility to go to the Council of State is a 
general possibility against all administrative legal acts in Belgium and should thus not again be 
specifically mention ed in the law nor in the Royal Decree(s). The EU would like to thank the Chinese 
authorities once again for providing comments. We are confident that the responses conveyed today 
sufficiently clarify the issues raised and will allow to a positive outcome.  
2.1.3.17   China - National Standard of the P.R.C., Lithium Ion Cells and Batteries Used in 
Portable Electronic Equipments - Safety Technical Specification, G/TBT/N/CHN/1576  (ID 
70643) 
2.164.   The delegation of the Republic of Korea  provided the following statement.  Korea recognizes 
the importance  for China to amend the "National Standard of the P.R.C., Lithium Ion Cells and 
Batteries Used in Portable Electronic Equipments - Safety Technical Specification (GB 31241)" in 
order to protect consumers, and Korean companies are making efforts to faithful ly comply with the 
standard. However, the Korean industry has voiced difficulties in regulatory compliance, so we would 
like to deliver Korean companies' concerns. On 7 May 2022, China issued on its MIIT (Ministry of 
Industry and Information Technology of the People's Republic of China) website the Draft for 
Approval of GB 31241. The Draft contains marking requirements in clause 5.3.1 that are not 
harmonized with the IEC 61960 -3. Regarding cell body marking requirements, we request China not 
to diverge from  the international standard and maintain the exceptions provision as it stands in 
China's current regulation (GB 31241 -2014, clause 5.3.1) so that unnecessary obstacles to trade 
can be avoided. If the Draft is approved and implemented without modification,  replacement of 
production facilities and rework of existing products will be required solely for cells to be exported 
to China, which will be quite costly and time -consuming, laying an excessive burden on the relevant 
industry.  
2.165.   In response to Korea's past  comments and requests for reconsideration of the regulation, 
China answered that "with regard to the safe use of cells and batteries, cells cannot be traced and 
identified effectively without necessary marking information", and we appreciate China's earne st 
replies. However, if cell body marking is for product tracking and identification purposes, we believe 
that in the same way as the requirement for cells with a maximum surface area of below 4cm2 (in 
Draft's clause 5.3.1), China's objectives can be suffi ciently achieved by marking on the cell body the 
minimum necessary information, which is the polarity and a Manufacturer's Code, while the Code 
contains all the rest of the required information, such as rated capacity, date of manufacture, batch 
number, et c. In other words, we request that China consider revising the standard to require marking 
only the two following elements: the polarity mark and a Manufacturer's Code (such as a QR code, 
etc.), on the cell body. Additionally, in case the amended technical  regulation on cell marking 
 
41 Please see 'Lois coordonnées du 12 janvier 1973 sur le Conseil d'Etat'. An online version in French is 
available at:  
http://www.ejustice.just.fgov.be/cgi _loi/change_lg_2.pl?language=fr&nm=1973011250&la=F   
42 Please see previous footnote for the reference to the concerned law.  
43 For previous statements follow the thread under ID 706 . G/TBT/M/87  
 
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  requirement is to be implemented, we request that a sufficient grace period of more than one year 
be given in consideration of the time required for the industry to adapt to the new regulation.  
2.166.   In response, the delegation of China provided the following statement. Marking for 
identification is highly important for the safe use of cells and batteries. As a matter of fact, cells are 
an important component of batteries, and without necessary identification information, cells cannot 
be traced or identified effectively. In recent years, cells without identification have caused much 
confusion in market regulation. Therefore, through extensive investigation and consultation during 
the formulation of the standard we have introduced GB 312 41-20XX which proposed relevant 
requirements for cell body identification.  
2.1.3.18   European Union - Proposal for a regulation of the European Parliament and the 
Council laying down harmonised rules on artificial intelligence (Artificial intelligence act) 
and amend ing certain union legislative acts (ID 73644) 
2.167.   The delegation of China  provided the following statement. We support the EU's governance 
on artificial intelligence, however, from not creating unnecessary trade barriers, China would like to 
raise concerns as follows : 1. It is suggested to narrow the definition of "artificial intelligence system " 
by eliminating Annex I (b) and (c) or further specifying the technologies mentioned in Annex I (b) 
and (c). Firstly, the scope of the definition of "artificial intelli gence system " in article 3 (1) and Annex 
I of the act is too broad. The wording of the definition indicates a large number of software 
applications, it is unreasonable to classify all of them as artificial intelligence. For example, the logic -
based approac h in (b) is commonly used to check the form filling, and the "statistical methods ", 
"Bayesian estimation " and "search and optimization methods " referred to in (c) are widely used in 
technologies of receiver for all digital communication systems, which is i rrelevant with artificial 
intelligence. Secondly, the expansion of the scope of the definition of AI would also expand the scope 
of high -risk AI, which would result in the enterprises of the AI systems act covered in the supervision 
would be much higher th an the 10% expected by the European Commission, exacerbating the 
burden of enterprises and regulation, which is inconsistent with the legislative purpose of the EU.  
2.168.   2. It is recommended to clarify the specific scope of the safety components in Article 3 (1 4), 
for example, to make a list. The safety component is related to the defined risk level for artificial 
intelligence systems, but the definition of the safety component in the draft is not clear. In the 
existing NLF harmonization regulations, the Directi ve 2006/42/EC has an unequivocal definition of 
"safety components" with an updated indicative list annex V. It is suggested to refer to Directive 
2006/42/EC to clarify the specific contents of "safety components" by making a list so that the 
providers can accurately judge whether their artificial intelligence system belongs to high -risk level 
or not. 3. It is suggested to make public classification guidance of prohibited artificial intelligence 
referred to in article 5 (1) as soon as possible. The wording n ow used to define prohibited artificial 
intelligence is unclear and subjective which makes it difficult for compliance. 4. It is suggested to 
eliminate the requirement of "Free of errors and complete " in article 10 (3). If not, please further 
clarify the d efinition. The new data would be generated in AI training and testing, and the datasets 
would be enriched after being placed on the market. Few datasets could comply with the requirement 
of "free of errors and complete ", which is inconsistent with the curr ent state and development of the 
AI industry. Also the act regulates AI systems from the angle of traditional products without 
considering the dynamic characteristics of the life cycle of machine learning systems development.  
2.169.   5. It is suggested to eliminat e the requirement to provide source code in article 64(2) and 
point 4.5 in Annex VII. "the market surveillance authorities shall be granted access to the source 
code of the AI system " in article 64 does not meet the requirements set out in Chapter 2, Title III. 
We believe that systematic verification and actual testing, are enough to identify and correct the 
harmful results effectively, and should be the methods to test whether an AI s ystem accords with 
its design. Instead of accessing the source code of the AI system, requirements on the related 
verification and testing are the valid methods to guarantee and improve the safety of AI products. 
In addition, the obligatory provision of so urce code also deviates from the common international 
practice of protecting source code as a commercial secret. 6. It is suggested that article 70 
emphasize and specify the confidentiality obligation for all data information from providers, by the 
EU Comm ission, by the EU member States  and their market surveillance authorities, notifying 
bodies, and other participating bodies. In this act, AI providers are required to provide a large 
number of datasets and technical documents. Therefore, the EU shall stren gthen the controls on this 
 
44 For previous statements follow the thread under ID 736 . G/TBT/M/87  
 
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  information security in some aspects. 7. It is suggested to keep "Penalties " in article 71 inconsistent 
with the NLF. Penalties under the NLF are usually regulated by member States, such as RED, LVD 
and EMC, as "The Member States  shall lay down the rules on penalties applicable for infringement 
of the provisions of this Regulation ". If not, it is suggested to revise the calculation measures of the 
penalties in article 71, and reassess the fines, to make sure the penalties are prop ortionate to the 
performance. For example, it is necessary to consider modifying the fines of "total worldwide annual 
turnover " to the fines of "turnover in the EU market ". In addition, this article is too strict for non -
compliance (under Chapter 2, Tittle  III) which may result in fines of 4% of worldwide turnover. It is 
suggested to classify fines between essential requirements and other administrative requirements 
with reference to NLF. For example, for the non -compliance with essential requirements in Ge rmany, 
the fines are about 100,000 euros, and for the non -compliance with administrative requirements, 
such as incorrect CE mark, unqualified random documents, etc., would be about 10,000 euros in 
accordance with directive RED under NLF.  
2.170.   8. It is suggested  to amend provisions in Annex VII with reference to No.768/2008/EC. 
Conformity based on an assessment of the quality management system and assessment of the 
technical documentation in Annex VII does not refer to the conformity assessment defined in the 
new legislative framework. With a view to ensuring the integration of the new legislative framework, 
it is suggested to amend provisions in Annex VII with reference to No.768/2008/EC, for example, to 
explicitly cite Module H of No.768/2008/EC. 9. It is sugges ted transition period is 48 months in 
Chapter 2 ，Title III. The presumption of conformity under Chapter 2, Title III shall be carried out by 
the provider after the publication of the harmonized standards. It usually takes more than 36 months 
for standards b odies to lay down new standards, and another 12 months is needed to adjust products 
and systems, conduct conformity assessments and prepare all required documentation.  
2.171.   In response, the delegation of the European Union  provided the following statement. The 
European Union (EU) would like to thank the P.R. of China for their comments on notification 
G/TBT/N/EU/850 , "Proposal for a Regulation of the European Parliament and of the Council laying 
down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending cer tain 
Union legislative acts". On 8 July 2022, the EU provided a detailed written response to the comments 
received. The EU would like to address voiced China's concerns as follows. 1. As regards the scope 
of the definition of AI, the Commission aimed to pr opose a definition as technologically neutral and 
future proof as possible so it can be applied to systems resulting from innovation and market 
developments. The notified draft's definition builds on the internationally recognized definition of the 
Organis ation for Economic Co -operation and Development (OECD), with only minor adjustments. 
such as the inclusion of "content " (generative AI systems) and the addition of an Annex with the list 
of techniques and approaches. The Annex aims to provide legal certain ty to operators and to support 
the dynamic character of the overall definition, insofar as the Commission can update the list and 
clarify its scope when required due to technological and market developments. It is important to 
note that, in order for a cer tain system to be classified as AI for the purpose of the notified draft, it 
is necessary that the system fulfils the "functional" definition in Article 3(1) of the notified draft. In 
particular, it is necessary that the system "can, for a given set of hum an-defined objectives, generate 
outputs such as content, predictions, recommendations, or decisions influencing the environments 
they interact with ". Such capacity could ensue from the use of a learning approach, but also 
otherwise by other approaches such  as reasoning or modelling listed in Annex I. Recital 6 further 
specifies that AI systems can be designed to operate with varying levels of autonomy. The impact 
assessment accompanying the notified draft highlights the objective to cover with the proposed 
definition not all software systems, but those that pose specific challenges in terms of complexity, 
opacity, certain level of autonomy or unpredictability.  
2.172.   2. While substantially building on the definitions set in relevant existing EU safety legislation 
(e.g. machinery and cableway installation), the definition of "safety component" is kept wide to cover 
AI systems having a safety implication for high -risk products, both in an embedded and non -
embedded form. As appropriate, the Commission can, in the futur e, issue guidance on this issue in 
order to provide the necessary legal certainty to operators. 3. The formulation of the prohibitions of 
harmful practices in Article 5 uses concepts that are not new to European Union law. They have 
already been used in ot her EU legal acts (e.g. Directive (EU) 2019/21612, Directive (EU) 
2018/18083). 4. In relation to "free of error and complete datasets", Article 8 specifies that all 
requirements should be implemented in light of the intended purpose of the system and the r isk 
management framework, which takes into account the acceptable risks and is limited to what is 
feasible according to the state of the art (Articles 9(3) and (4) of the notified draft). The EU takes 
note of the suggestion concerning further clarification . 5. The notified draft clearly protects the G/TBT/M/87  
 
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  source code as intellectual property (see Article 70(1)(a) read in conjunction with Directive 
2009/24/EC on the legal protection of computer programs). On that basis, Article 64(2) makes the 
access to source cod e dependent on two strict cumulative conditions: 1) there must be a reasoned 
request on the side of the market surveillance authority, and 2) access must be necessary to assess 
the conformity of the high -risk AI system with the requirements set out in Titl e III, Chapter 2. These 
conditions strike a balance between intellectual property rights protection and safety protection to 
safeguard important public interests, in line with the EU's commitments under the WTO agreements.  
2.173.   6. Article 70 already requires na tional competent authorities and notified bodies involved in 
the application of the notified draft to respect the confidentiality of information and data obtained in 
carrying out their tasks and activities. This is also extended to other national public au thorities or 
bodies which supervise or enforce EU law protecting fundamental rights who may gain access to the 
technical documentation (Article 64(6)). Furthermore, the Market Surveillance Regulation (EU) 
2019/10205 applies in its entirety in relation to t he market surveillance activities performed pursuant 
to the notified draft. Article 17 of the Market Surveillance Regulation requires market surveillance 
authorities to respect the principles of confidentiality and of professional and commercial secrecy 
and Article 18 clarifies the procedural rights of operators as regards any measure taken by a market 
surveillance authority. Furthermore, effective judicial remedy and settlement of disputes is regulated 
by the administrative law of the member State concerne d. Enforcement of intellectual property rights 
in the EU is guaranteed in accordance with Directive 2004/48/EC on the enforcement of intellectual 
property rights.  
2.174.   7. The penalty system in the notified draft follows the model of the New Legislative 
Framewor k system but also of other existing legislation, such as the General Data Protection 
Regulation (GDPR). This implies that member States remain responsible for laying down the rules 
on penalties, including administrative fines, applicable to infringements o f the notified draft. 
However, some harmonisation elements are provided, e.g. on the capping and types of 
infringements associated. The reference to the "total worldwide annual turnover" is consistent with 
already applicable legislation in the field of dat a protection (GDPR). While 4% is the maximum 
capping, it is up to the member States to foresee in their national laws the amount applicable to the 
relevant infringement. 8. The EU takes note of the suggestion to revise Annex VII with reference to 
Decision No 768/2008/EC, although it notes that it is necessary to account for the specificities of AI. 
9. Finally, the EU takes note of the suggestion on the transition period although it notes that it 
considers the transition period sufficient for the industry to  adjust to the new legislation. The EU 
would like to thank the Chinese authorities once again for providing comments on the notified draft 
and hopes that these responses sufficiently clarify the points raised.  
2.1.3.19   Sri Lanka - National Environmental (Plastic Ma terial Identification Standards) 
Regulations No. 01 of 2021 (ID 71145) 
2.175.   The delegation of the United States  provided the following statement. On 21 January 2021, 
the Minister of Environment published in the Gazette of the Democratic Socialist Republic of Sri 
Lanka, the National Environmental (Plastic Material Identification Standards) Regulations No. 01 of 
2021 (PMI Regulation). Sri Lanka has not yet notified this PMI Regulation to the WTO TBT Committee. 
We appreciate Sri Lanka's willingness to engage with our concerns, most recently through the 
February 2022 comments made by the Ministry of Environment to the U nited States Government 
and to US industry. We are encouraged by Sri Lanka's confirmation that it will take necessary steps 
to notify the PMI Regulation, along with any implementation guidelines, to the WTO TBT Committee 
before enforcement. While we unders tand Sri Lanka's regulatory objectives, we request further 
clarification on the broad scope, vague language, and potentially burdensome labelling requirements 
of the PMI Regulation. For example, neither the PMI Regulation nor the draft implementation 
guide lines provide guidance on sizing, placement, or colour of the marks; the manner in which such 
marks should be printed or affixed to products and/or packaging; or information on how conformity 
will be assessed. The clarifying language in the draft implement ation guidelines raises additional 
questions regarding the scope of products Sri Lanka seeks to include in the PMI Regulation and does 
not explicitly exclude plastics used in electronic products.  
2.176.   Can Sri Lanka elaborate on how it will address these concern s when implementing the PMI 
Regulation, including whether the PMI Regulation or its implementation guidelines will provide the 
industry -requested exemptions to these labelling requirements? Can Sri Lanka also clarify the 
 
45 For previous statements follow the thread under ID 711 . G/TBT/M/87  
 
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  intended scope of the PMI Regulatio n, including if the regulation applies only to final products, or if 
it applies to all constituent plastic inputs and plastic packaging as well? We encourage Sri Lanka to 
use existing international standards for plastic material identification, including t hose used in 
packaging as the basis for any implementing measures for this regulation. For example, ASTM 
D7611/D7611M and DIN 6120 are widely accepted standards for plastic packaging used by industry 
on a global basis. The United States appreciates Sri Lan ka's consideration of these comments. We 
look forward to learning more about how Sri Lanka plans to implement the PMI Regulation and its 
implementation guidelines, as well as Sri Lanka's WTO TBT notification of these measures.  
2.177.   In response, the delegation o f Sri Lanka  provided the following statement. We would like to 
thank the delegation of the United States for its interest on Sri Lanka's regulation on National 
Environmental Plastic Material Identification Standard No. 01/2021 published through the Gazette  
No. 2211/50 dated 21 January 2021. Though this regulation has been published, it has not yet been 
enforced since the implementation guidelines are still to be finalized. The Central Environmental 
Authority has drafted implementation guidelines in consulta tion with the industrial sector. My 
delegation would like to mention that the Ministry of Environment had a bilateral meeting with the 
Embassy of the United States in Colombo to further discuss this matter in January 2022. After the 
meeting, the draft guid elines were shared with the Embassy of the United States for their comments.  
2.178.   In furtherance to this, the authorities are now making consultations with Chambers of 
Commerce and various industrial groups before they are submitted to the Plastic Expert Commit tee 
chaired by the Central Environmental Authority, which would formulate the final guidelines. At the 
end of such envisaged process, the authorities will arrange to incorporate the final guidelines in the 
National Environmental PMI standard regulation No.  01/2021. Thereafter, Sri Lanka will take 
necessary steps to notify the final Regulation, along with the implementation guidelines, to the TBT 
Committee for Members' comments before its legal enforcement. My delegation has taken due note 
of the concerns ex pressed by the delegation of the United States today which will be conveyed to 
our national focal points for their consideration.  
2.1.3.20   Brazil - Technical Regulation 14, 8 February 2018, to set the additional official 
identity, quality standards for wine and der ivatives of grape and wine products as well as 
the requirements to be acquainted and Technical Regulation No. 48, 31 August 2018 
published in the Official Gazette on 10 September 2018, G/TBT/N/BRA/613 , 
G/TBT/N/BRA/613/Rev.1/Add.1 , G/TBT/N/BRA/956  (ID 56846) 
2.179.   The delegation of the European Union  provided the fo llowing statement. The European Union 
would like to thank Brazil for notifying the draft Technical Regulation on the identity and quality 
standards for wines and derivatives of grape and wine and to note that the EU written comments 
were sent to Brazil on 7 December 2021. The European Union would like to ask Brazil about the 
timing of the next steps of the revision procedure of the Technical Regulation, in particular the 
estimated dates of the publication of replies to the comments received during the publi c consultation 
and the TBT notification process, of the announced public hearing and of the publication and 
notification to the TBT Committee of the revised drat regulation. The European Union would like to 
shortly recall its main general concerns and refe r for details to its written comments. First, the EU 
would like to kindly ask Brazil to refrain in the ongoing revision from further enlarging the already 
long list of analytical parameters, many of them diverging from recommendations of the 
International Organisation of Vine and Wine. To avoid creation of unnecessary obstacles to trade, it 
is important to clarify that the new parameters do not need to be certified for imported wines and 
to guarantee that the Brazilian methods of analysis for the new parame ters are consistent with OIV 
recommendations.  
2.180.   Second, the EU would like to invite Brazil to aim at resolving in the ongoing revision the 
longstanding issue of the classification of sparkling wine according to sugar content, which is 
currently discussed in  the OIV, and in the interim, to align with OIV's glucose and fructose method 
of analysis for the determination of sugar content. As in past TBT Committees, the European Union 
would like to encourage Brazil to seek international consensus within the OIV fr amework on issues 
relevant to our bilateral trade, such as categories of sparkling wines related to sugar content, import 
documentary evidence and list of analytical parameters for imports. The European Union appreciates 
the efforts previously demonstrated  by Brazil to facilitate the implementation of its wine regulations 
for importers. However, Brazil is invited to make use to the maximum extent possible of the 
 
46 For previous statements follow the thread under ID 568 . G/TBT/M/87  
 
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  recommendations of the OIV when revising the relevant technical regulations and to remove the 
current requirements that are not in line with the OIV standards on identity and quality of wine and 
on maximum content limits. The European Union is prepared to work bilaterally with Brazil with 
regard to the ongoing revision, invites Brazil to take into ac count the EU written comments and looks 
forward to the opportunity to review the revised draft regulation.  
2.181.   The delegation of Peru provided the following statement. Peru thanks Brazil for the 
opportunity to submit comments on the draft regulation establishi ng the standards of identity and 
quality, as well as the complementary rules relating to the labelling and production process for wines 
and derivatives of grapes and wine, published by SDA Ordinance No.  411 and notified as 
G/TBT/N/BRA/613/Add.3  of 18  October  2021. In this connection, Peru kindly invites Brazil to 
respond to the comments sent to Brazil's TBT/WTO contact point by email on 7  December  2021, 
which we reiterated on 14  February  2022. Peru stated that Brazil needed to bring its standard s into 
line with the Regulation on the Pisco Designation of Origin (RDOP), especially with regard to the 
analytical parameters. For example, the draft establishes a minimum anhydrous alcohol presence of 
150 mg/100 ml for higher alcohols while the RDOP sets  it at 60 mg/100 ml of anhydrous alcohol. 
We would therefore be grateful if Brazil could inform us about the progress made in assessing our 
comments and the notified draft regulation.  
2.182.   In response, the delegation of Brazil  provided the following statement. Brazil would like to 
thank the European Union for its statement and recall that the Ministry of Agriculture, Livestock and 
Supply (MAPA) Ordinance No. 346, published on 1 July 2021, opened public consultations regarding 
a draft regulation that establishes identity and quality standards, as well as complementary rules for 
labelling and production process of wine and grape -derived wines. In response to the requests from 
many stakeholders, Brazil extend the time for comments until 7 December, what has been not ified 
as G/TBT /N/BRA/613/Add.3 . Brazil appreciates the comments received from the EU and from other 
Members on this notification, which are important to improve the regulation of wine, grapes and 
their products in Brazil. We have replied to the comments and are currentl y preparing the publication 
of replies. We also confirm that the draft regulation will be amended following the public consultation 
and that a public audience will be held so that all interested parties have another opportunity to 
review it. It will also b e another opportunity for comments and suggestions regarding the proposed 
regulation. We are not able to estimate the dates of the next steps, though. Brazil appreciates the 
suggestions and comments from the European Union, from the United States and from all other 
partners for the technical regulation regarding the identity and quality of wine, grapes and their 
products and is certain that, by conducting this open and transparent regulatory process, all 
enquiries will be duly addressed and any remaining do ubts will be clarified.  
2.1.3.21   China - Cybersecurity Law (ID 52647) 
2.183.   The delegation of the European Union  provided the following statement. The EU would like 
to refer to its statements at previous TBT Committees with regard to the Cybersecurity Law, namely 
that th e 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 National Informa tion Security Standardisation Technical 
Committee (also known as TC260) has released the draft of a short (non -binding) guideline on the 
identification of "important data" (the Identification Guideline). The concept of "important data" was 
first introduced  by the Cybersecurity Law and has more recently been adopted into the Data Security 
Law. However, the term has never been comprehensively defined. Under the Data Security Law, 
regional and sectoral regulators have already been tasked with formulating catal ogues of "important 
data" for their respective sectors. The Identification Guideline, released on 13 January 2022, is the 
first step towards implementing this national classification system for "important data". The EU urges 
China to proceed with these gui delines as soon as possible and take into account the EU comments 
submitted during the public consultation.  
2.184.   The EU has taken note of the publication of the Call for Comments on the "(Draft) Outbound 
Data Transfer Security Assessment Measures" by the Cybers pace Administration of China (CAC). 
The movement of information across national borders drives today's global economy. Cross -border 
data transfers with protection, allow businesses and consumers access to the best available 
technology and services, whereve r those resources may be located around the world. The seamless 
transfer of information with trust, supports the growth of the global digital economy as well as the 
 
47 For previous statements follow the thread under ID 526 . G/TBT/M/87  
 
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  expansion of international trade. Companies need to be able to efficiently transfer data ac ross 
borders in order to respond to customers' needs, deliver goods and services to consumers, process 
payments and provide customer support. It is essential that regulatory frameworks for data allow 
companies to compete globally, foster the creation of ne w business models and ensure a level 
playing field, with legal certainty and stability, as well as the protection of personal data. Conversely, 
the EU understands that the "Outbound Data Transfer Security Assessment Measures " would impose 
broad data and se rver localization requirements, notably under the umbrella of national security, 
covering potentially all sectors of the economy. Such constraints could severely limit cross -border 
data transfers. Also, we are concerned that they put foreign operators at a  disadvantage compared 
to local ones. The scope of some of the provisions remains unclear and it is not possible to determine 
which types of data and which kinds of transfers would be covered by the measure. Additionally, 
some of the terms used in the meas ure are not well defined. While these terms may be defined in 
other pieces of legislation, the concerns we have raised there would also apply here. For example, 
those subject to interpretation, in particular, the vague concepts of "important data " and "critical 
information infrastructure ". It would be important to address these issues to ensure legal certainty. 
The EU urges China to take on board its comments provided during the public consultation.  
2.185.   The EU has also taken note of the "Critical Information In frastructure Security Protection 
Regulation", which is effective as from September 2021. The Regulations provide long -awaited 
details about how critical information infrastructure operators will be designated and what their 
responsibilities will be in orde r to protect the security of the networks that they build and operate. 
Since the Cybersecurity Law came into effect in 2017, EU companies have faced uncertainty about 
whether or not they and/or their customers would be deemed critical information infrastru cture 
operators and therefore face regulatory obligations in data security, procurement, cross -border data 
flows and other areas. However, the new Regulations do not resolve the overlap between the Ministry 
of Public Security (MPS) -administered system for network security, known as the Multi -Level 
Protection Scheme (MLPS, now updated to MLPS 2.0) and the critical information infrastructure 
protection regime. The EU urges China to clearly distinguish between the compliance obligations – 
especially with regar d to product and service procurement – applicable to Critical Information 
Infrastructure on the one hand, and to networks above MLPS Level 3 on the other, as in reality, 
these two sets of obligations are increasingly being equalled. The EU calls on China t o implement 
the provisions in a non -discriminatory manner, respecting the principles of proportionality, necessity 
and technology neutrality, and ensuring adequate protection of intellectual property (IP). The EU 
requests that China notify draft measures c oncerning any sectoral implementation to the WTO.  
2.186.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding China's Cybersecurity Law and would like to refer to the previous statement we made at 
the last TBT Commi ttee in March 2022. Japan is also concerned with the related regulations and 
guidelines such as the Guidelines for Identification of Critical Data that China released for public 
consultation in January 2022. Japan would like to request China to refer to ou r comments such as 
our request to clarify the criteria about identification of critical data submitted by the Japanese 
Government for the public consultation. Japan would like to request that China provide notifications 
of the enforcement regulations and g uidelines to the TBT Committee and consider comments from 
stakeholders. In addition, Japan would like to request that China provide adequate lead time from 
the completion of these regulations and guidelines until their enforcement, and to implement these 
measures in a transparent manner.  
2.187.   The delegation of Australia  provided the following statement. Australia reiterates our 
previous position regarding China's Cybersecurity  Law and related laws, including the Personal 
Information Protection Law and Data Secur ity Law. As we set out in Australia's submissions to 
China's consultation on the then proposed laws, we welcomed a number of revisions to both these 
draft laws. Nonetheless, Australia still has concerns with the final legislation particularly around 
extra-territoriality, trade retaliation measures, compliance costs for firms and the overall scope. We 
remain concerned that provisions in these laws have the potential to create inconsistencies with 
WTO rules. We note that any measure or counter measure taken u nder these laws should only be 
applied consistently with China's WTO obligations. We also continue to remain concerned about the 
lack of clarity when it comes to definitions, jurisdiction and a number of other fundamental elements, 
to enable businesses ope rating in China to fully understand and implement their new obligations. 
We continue to urge China to consider the concerns of business and Members in the implementation 
of these measures and development of future measures. We look forward to continuing to  work 
closely with China on these issues.  G/TBT/M/87  
 
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  2.188.   The delegation of Canada  provided the following statement. Canada would like to reiterate 
its concerns with China's suite of cybersecurity and cryptography/encryption laws and related 
implementing regulations which  create confusion and complicate businesses' ability to comply with 
all of them, due to their unclear scope, interaction and adherence to the principles of the TBT 
Agreement. Canada would also like to reiterate its request for a notification timeline for t hese 
measures. With respect to the Practical Guidance of Cybersecurity Standards —Technical 
Specifications for Certification of Cross -border Handling of Personal Information: Canada appreciates 
China's efforts to clarify Article 38 of the Personal Informati on Protection Law (PIPL)'s paths to cross -
border transfer of personal information, with the voluntary "Certification Technical Specifications" 
included in the draft of the Practical Guidance of Cybersecurity Standards, published on 7 April 2022. 
However, t his certification, as a parallel path to security assessment, creates additional requirements 
on cross -border data transfers, compared to domestic treatment of data transfers, which raises 
significant concerns regarding consistency with the principles of n ational treatment, necessity and 
legitimate objective.  
2.189.   Regarding the Critical Information Infrastructure (CII) Security Protection Regulations, the 
Cybersecurity Review Measures, the Draft Regulations on Network Data Security as well as the Draft 
Measures for Security Assessment of Cross -Border Data Transfer, Canada would like to reiterate our 
views and comments made in November 2021 and March 2022 during the TBT Committee meetings.  
2.190.   The delegation 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 L aw entered into force on 1 June 2017, in spite of serious and long -standing 
concerns from the United States and many other international stakeholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
sometimes general in scope, and sometimes sector -specific.  
2.191.   We have many concerns regarding China’s Cybersecurity Law and related measures, which 
impose far -reaching, highly trade restrictive conditions on foreign ICT products through "secure and 
controllable " requirements, enforced by cybersecurity review regime checks.   Such requirements are 
largely based on a planned update and expansion of the Ministry of Public Security’s Multi -Level 
Protection Scheme (MLPS).  As one example, China 's 25 January 2018 draft measure, "Information 
Security Technology – Guidelines for Grading of Classified Cybersecurity Protection ", appears to 
repeat and elaborate upon China 's MLPS.  Most recently, in February 2022, the United States 
provided formal comments to China on its draft "Security Technical Requirements of Specialized 
Cybersecurity Products " notified as G/TBT/N/CHN/1649 . China 's response, while appreciated, 
magnifies some existing US concerns on prot ection of trade secrets and CBI, data storage, and 
cross-border data transfer requirements. Numerous other concerns have been laid out in prior 
interventions by the United States and other Members at prior Committee meetings.  
2.192.   Additionally, the United Stat es reiterates its serious concerns regarding China 's 
Cryptography Law, which went into effect on 1 January 2020. The United States is concerned that 
this law codifies potentially far -reaching, highly trade restrictive cryptography -related constraints on 
foreign ICT products. Because these issues are technically complex and China 's approach appears 
to be both novel and would have a potentially widespread impact in the commercial sector, the 
United States requests that China undertake in -depth consultations w ith 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 b efore 
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.  
2.193.   In response,  the delegation of China  provided the following statement. The Cybersecurity 
Law aims to safeguard China's sovereignty, national security and public interests in cyberspace, and 
to protect the legitimate rights and interests of citizens, legal persons and other organizations. It G/TBT/M/87  
 
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  does not restrict foreign enterprises, technologies and products from entering the Chinese market, 
nor does it restrict the lawful, orderly and free flow of data. Since the implementation of the 
Cybersecurity Law, it has played an i mportant role in safeguarding cybersecurity, safeguarding 
China's national sovereignty in cyberspace, and protecting citizens' legitimate rights and interests. 
It has effectively enhanced the awareness of cybersecurity, improve the protection skills on 
cybersecurity, providing a security guarantee for the development of the network industry and 
technology.  
2.1.3.22   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 , G/TBT/N/EU/845  (ID 59448) 
2.194.   The delegation of China  provided the following statement . China thanks the EU for 
postponing the application date of MDR and adjusting the transitional period of IVDR. However, in 
view of the important regulatory role of the above regulations on medical devices and in vitro 
diagnostic medical devices, China pro poses the following: 1. We encourage the EU to extend the 
validity of MDD and AIMDD certificates issued by the notified bodies for another year. The certificates 
could be effective until 26 May 2025 as long as the certificates are valid before the cut -off date of 
26 May 2021 unless major changes happened to the products, the reasons are as follows: At present, 
notified bodies are faced with unprecedented pressure on MDR certification for medical devices 
already and are due to be placed on the market. In add ition, more audit requirements are added in 
MDR, leading to a long period of audit cycle and slowing the process of certificates. Therefore, it is 
suggested to extend the validity of the previous certificate to 26 May 2025.  
2.195.   2. We would encourage the EU to  consider issuing OBL (own brand labelling) guidelines 
accompanying MDR, so as to simplify the conformity assessment procedures of new products under 
OEM/ODM, allowing notified bodies to directly recognize OBL applications with OEM/ODM -MDR 
certificates, ad justing OBL responsibilities under Article 16 -1 (a) of MDR, or allowing ODM to directly 
provide core technical documents to certificate authority. OEM (Original equipment manufacturer), 
ODM (original design manufacturer) and OBL are widely existing and evo lving into different 
combination modes due to the international division of labour. In view of protecting the core 
technologies and intellectual property rights of original equipment manufacturers, the following two 
common conditions shall be considered in  the re -certification: (1) Regarding conditions that 
OEM/ODM whose original equipment has been approved by notified bodies: OBL could no longer 
need to provide all technical documents of OEM/ODM products, especially the core technologies of 
OEM/ODM. China recommends that the notified bodies of OBL could recognize the audit report and 
certificate issued by notified bodies of OEM/ODM. We consider that mutual recognition among 
different certification bodies can simplify the conformity assessment procedures. (2 ) Regarding to 
conditions that ODM whose original equipment has not been approved by notified bodies: OBL does 
not need to provide all technical documents of ODM products, especially the core technologies of 
ODM. OBL could build an index with the core tech nologies of ODM products. If necessary, ODM can 
directly provide the core technical documents to the agencies designated by OBL for on -site/off -site 
audits. (3) It is suggested to modify and simplify the obligations needed by OBL, and strengthen the 
post-marketing supervision of OBL products. For example, to simplify the document and supervision 
requirements with reference to the original MDD directive NB -MED/2. 5.5/Rec 5 Conformity 
Assessment of Own Brand Labelling. It is not reasonable that OBL is require d to undertake all 
responsibilities of manufacturers.  
2.196.   3. standardizing the requirements and time limits during the transition period of IVDR among 
each member when handling FSC for IVDD  products. During the transition period, many products 
are faced with the co -existence of IVDR and IVDD, leading to confusion on certification. The 
requirements for FSC (Free Sales Certificate) in different EU Members are quite different. 4. speeding 
up the construction of relevant modules of Eudamed database. At present, there is a huge difference 
between the functions of EU Eudamed database and those described in regulations. Many function 
modules have not been opened or are inconvenient to use, for examp le, Clinical Investigations and 
performance studies module and Vigilance and post -market surveillance module have not been 
opened; although the registration  module and UDI/Devices registration module have been opened, 
functions of many sub -modules are sti ll imperfect, such as (i) the database registration information 
cannot be shared; (ii) enterprises cannot upload product information in batches; (iii) unstable audit 
of links between importers and manufacturers, etc, bringing many troubles in respect of ma rketing, 
 
48 For previous statements follow the thread under ID 594 . G/TBT/M/87  
 
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  circulation, registration and basic data access of enterprise products in EU, so it is particularly 
important to improve the availability and software stability of Eudamed database. 5. We would like 
to reiterate our concerns on protecting the trad e secrets of enterprises. At present, the detailed 
information of importers published by the EU Eudamed database involves the trade secrets of 
enterprises. In order to protect their own interests, many enterprises add an extra middle layer for 
shelter, whi ch would increase burdens on enterprises. It is suggested that the importer data could 
be protected in a proper way (for example, the importer information could be partially blocked).  
2.197.   The delegation of Japan  provided the following statement. 1. Since the M DR's 
implementation dated 26 May 2021, Japanese manufacturers have been unable to ship new products 
and medical devices with new features to Europe. In the previous meetings, Japan stated, "We had 
received reports from many manufacturers undergoing technic al document review that there had 
been no progress for a long period of time since the start of the review and that it is not foreseeable 
that the review will be completed and certificates issued by the date of application of the MDR, and 
that more than on e year has passed since the start of the technical document review. We would like 
the EU to investigate the cause of this issue and explain the measures to improve the situation ". 
Japan appreciates the EU's statement at the last meeting that the MDCG is cl osely monitoring the 
situation of the examinations. However, we continue to be informed by several manufacturers that 
more than 2 years and 3 months have passed since the technical document review started. It seems 
that there has been no improvement. Japan  would like to request that the EU continue to monitor 
the situation and make improvements as a regulator. The expiry date of MDD certificates is 27 May 
2024. Also, the products with the MDD certificates can be placed on the market or start to use until 
27 May 2025. In view of the delayed certification of MDRs, Japan requests that the expiry date be 
extended for one year to 27 May 2025 and 27 May 2026, respectively.  
2.198.   2. Japan appreciates the update of MDCG Guidance publication plan in May 2022. In the 
previo us meetings, Japan stated, "We request that public consultation be carried out prior to the 
publication of the MDCG, and that the guidance that is published be made mandatory with a 
transition period. The mapping plan for EMDN (European Medical Device Nome nclature) and GMDN 
(Global Medical Device Nomenclature) mentioned in the MDCG guidance publication plan is still not 
applicable. We request that a publication schedule be set and executed. Post -marketing surveillance 
and vigilance are required by the MDR. Though the plan for publication has been described, we 
request that it be published promptly." Japan requests continued consideration of this matter. 
3. Strict clinical evaluation is required even for relatively low -risk medical devices classified as 
Class I, IIa and IIb under the MDR. Japan requests that EU consider simplifying the clinical evaluation 
requirements for low -risk medical devices like in the case of Japanese pharmaceutical certification 
or US 510(k) regulations. As requested in the previous me etings, Japan continues to request that 
EU consider ensuring that the operation is not more trade -restrictive than necessary. 4. In the 
previous meetings, Japan stated "The publication plan in the EU Official Journal is not disclosed, and 
they were suddenl y promulgated. We request the release of the plan for the development and 
publication of harmonized standards for MDR and IVDR." Japan requests continued consideration 
related to the publication plan and setting an adequate transition period for MDR and th e IVDR 
harmonized standard.  
2.199.   5. Japan welcomes that Regulation (EU) 2022/112 which amends the transition period for 
IVDRs entered into force on 25 January 2022, which extends the transition period for three to five 
years, depending on the risk classificatio n of the device. However, at present, the Japanese IVD 
industry has reported that it has taken more than 15 months for certification. We are still concerned 
that many manufacturers will not be able to complete certification by the deadline despite the 
extension of the transition period. In addition, regarding the fact that there are only seven notified 
bodies for the IVDR as of May 2022, the European authorities have stated that the number of notified 
bodies is not an indication of capacity for certificatio n and that the EU does not expect to maintain 
the same number of notified bodies as existed under the IVD Directive before May 2022. However, 
at the moment Japan has concerns about the lack of infrastructure necessary for certification. 
Therefore, Japan wo uld like to request that the EU improve the capacity of notified bodies, including 
increasing their absolute number, so that certification can be carried out promptly. Meanwhile, four 
new guidance documents related to IVDRs have been issued since the last TBT Committee in March, 
and the total number of documents is eight. Japan would like to express our deep appreciation for 
the efforts of the MDCG (Medical Device Coordination Group) in this regard. Japan continues to 
request further expansion of the guidan ce documents and an indication of availability at the earliest 
possible date. We also continue to request that newly published guidance documents not be made 
mandatory immediately after publication, but be subject to a transition period of at least one yea r. G/TBT/M/87  
 
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  2.200.   The delegation of the United States  provided the following statement. The United States 
appreciates the European Union's (EU) continued efforts to apply a robust regulatory framework to 
ensure the safety of medical devices. Despite the Medical Device Re gulation (MDR) coming into force 
in May 2021, industry informs us that serious implementation hurdles remain that are creating an 
unpredictable market environment for medical technology manufacturers. These manufacturers 
report that implementation has been  slow, with long delays in securing certificates of compliance. 
One problem continues to be a lack of sufficient capacity to assess conformity to the MDR in a timely 
manner. For example, we understand that as of last year Notified Bodies were working to as sess the 
compliance of medical products covered by more than 25,000 CE certificates issued under the old 
Medical Device Directive. Most of these certificates are set to expire between January and May of 
2024 and medical devices covered by these certificate s will need to be recertified under the MDR 
prior to the May 2024 deadline. As of September 2021, however, only around 500 MDR certificates 
had been issued in total. With companies waiting anywhere from 13 to 18 months on average to 
have products reviewed and to receive initial certification, it will be impossible for most of the devices 
awaiting certification to remain available on the market once the May 2024 deadline passes.  
2.201.   Additionally, with a lack of capacity to assess conformity to MDR even for exist ing devices 
already on the market, MDR -designated Notified Bodies do not have the capacity to evaluate new 
products in a timely manner. This backlog jeopardizes the ability of European healthcare providers 
and patients to access the most cutting -edge techn ologies and innovative care that is becoming 
available in other parts of the world. Some companies are considering deprioritizing the EU market 
as the geography of choice for first regulatory approval of new devices. The ongoing COVID -19 
pandemic is also c reating supply chain disruptions and continues to pose challenges with conducting 
on-site audits and clinical investigations, further delaying the certification process. What is being 
done to speed up the conformity assessment process and to resolve the ba cklog of devices awaiting 
certification? Is the Commission considering providing additional resources or flexibilities to currently 
approved Notified Bodies to ensure these Notified Bodies have sufficient resources to meet existing 
demand? If so, what reso urces are being provided?  
2.202.   In order to maintain the strong presence of lifesaving medical technologies currently in the 
European market and broaden the range of new, innovative technologies that are able to enter, the 
United States implores the European Com mission to swiftly put solutions in place that resolve these 
ongoing challenges. The United States notes that in recent months, CEN and CENELEC issued a few 
standards that are harmonized with international standards. The United States appreciates this 
recent development and hopes to see this trend continue. We urge the Commission to use relevant 
international standards where possible to avoid creating unnecessary obstacles to international 
trade. As we have previously noted, the European Medical Device Nome nclature (EMDN) system, is 
not harmonized with the well -established Global Medical Device Nomenclature (GMDN). Contrary to 
EMDN, GMDN was developed with the support of ISO and the then -Global Harmonization Task Force 
(now the International Medical Device R egulators Forum) and is widely adopted by the medical 
device industry and used by over 70 national medical device regulators to support their activity. The 
United States uses the GMDN as the basis for our Global Unique Device Identification Database 
(GUDID ). 
2.203.   We are concerned that the Commission's selection of EMDN is undermining the 
interoperability of the two UDI systems (EUDAMED and GUDID) 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 mapping EMDN to GMDN so as to harmonize the UDI systems and reduce uncertainty 
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 potentially 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 the EU that demonstrates an 
attempt to map to GMDN. In fact, the EMDN is now available in Eudamed and th ere is no option of 
mapping to GMDN. Could the EU explain what actions it is taking to map EMDN to GMDN? Could the 
Commission also explain if there will be additional updates to EMDN? Additionally, can the 
Commission describe what updates they anticipate?  
2.204.   The delegation of Australia  provided the following statement. Australia remains concerned 
about the implementation of this measure as outlined in our intervention at the TBT Committee 
meeting in March 2022. Australia remains concerned about continued marke t access for Australian G/TBT/M/87  
 
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  organisations to the European market given the implementation timeframes for MDR and IVDR, in 
the context of difficulty accessing appropriately designated notified bodies. This also flows through 
to the capacity of manufacturers out side Australia to access the Australian market as previously 
outlined. Australia looks forward to the EU's continued engagement on this issue.  
2.205.   In response, the delegation of the European Union  provided the following statement. As 
announced in previous Com mittee meetings, the MDR officially entered into application on 26 May 
2021. This new Regulation significantly improves and upgrades the regulatory system for medical 
devices, aligning further with internationally developed principles by the International Medical Device 
Regulators Forum (IMDRF) and its predecessor, the Global Harmonisation Task Force (GHTF). It is 
important to remind Members that the shift between the Directives to the MDR is a gradual one, 
facilitated by a grace mechanism that allows for m edical devices in compliance with the Directives 
to continue to be in circulation until May 2025, in parallel with MDR certified devices. As regards the 
IVDR and as of May 2022, a staggered set of transition periods for IVDs was proposed by the 
European Co mmission. The proposed amendment to the IVDR has since been agreed upon by the 
European Parliament and Council. A measure explaining the adapted transitional provisions was also 
notified to the TBT Committee. The length of the transition periods depends on  the risk class of 
devices, with shorter transition periods for higher risk devices and longer periods for lower risk ones. 
In addition, the notified draft proposes a deferred application of the requirements for "in -house 
devices", i.e. those made and used  within the same health institution. We are happy to report that 
as of today, we now have 30 MDR designated Notified Bodies and seven Notified Bodies under the 
IVDR, which is four more since our last update.  
2.206.   As regards implementation, the Medical Device Co ordination Group (MDCG) continues to 
closely assess the situation on the ground. Given the large subset of additional requirements set out 
in the new Regulations and the need for both industry and Notified Bodies to adapt to these new 
requirements, we unde rstand that certification time under the MDR and IVDR is taking longer than 
certification previously taking place under the Directives. Understandably, it seems that both 
industry and Notified Bodies are currently in an adjustment period as regards expecta tions arising 
from the new requirements, especially those regarding clinical evidence. In certain cases, we also 
understand that Notified Bodies are requesting follow -up information or testing to be conducted by 
the manufacturer, so as to ensure the safety  of the devices and hence compliance with the new 
requirements. The turn -around time with the additional requested information by industry 
sometimes varies, which is inevitably leading to certain delays in the originally foreseen certification 
timelines. T he MDCG will continue to closely monitor the situation on the ground and has established 
regular contacts with Notified Bodies and industry in that regard. In addition, and within the remit 
of the current regulatory framework, the MDCG is working on a list  of various actions to enhance 
capacities of Notified Bodies and to avoid shortages of medical devices, as well as to improve the 
preparedness of economic operators. The sets of actions, which are foreseen for agreement in the 
coming months, are multifacet ed in their nature and will look into but are not limited to Notified 
Body capacity, the potential benefits of hybrid audits and ensuring that the EU market remains an 
innovation -friendly jurisdiction. In terms of implementation work, the Commission and me mber 
States are continuing work on key implementing acts and guidelines. To date, there have been more 
than 100 published guidance documents, including several key guidance on the transitional 
provisions and clinical requirements. In addition, the most rec ent milestone is the agreement on and 
publication of the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down 
common specifications in accordance with Regulation (EU) 2017/746. These common specifications 
are intended for several ty pes of high -risk diagnostics, such as HIV tests and SARS -CoV-2 tests. The 
specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the 
requirements for market actors and protecting EU patients.  
2.207.   As regards the Unique Device Ide ntification (UDI), allow us to underline the fundamental 
difference between the UDI and the Nomenclature, which are two topics that seem to be confused 
in high -level discussions. While the UDI system employed in the EU is based on internationally 
agreed up on principles, the Nomenclature, also known as the language of use, will be different. This 
was a decision taken after careful assessment and consideration. The EU would like to stress, once 
again, that the EU's choice for creating the European Medical Dev ice Nomenclature was founded on 
the need for a sensibly structured nomenclature that is transparent, open, completely publicly 
accessible and downloadable for free. There are currently no other nomenclature systems offering 
these characteristics. It is imp ortant to clarify that the choice of this nomenclature does not 
constitute a barrier. It is essential to avoid misinformation and confusion in this respect. Regarding 
the mapping exercise which was commenced in 2019 by virtue of a pilot study, the EU inves tment G/TBT/M/87  
 
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  in this work was reduced as a result of unsatisfactory results which were non -technical in their 
nature. Nevertheless, most recently, the EU has been approached on the topic and the work may 
potentially be reactivated, should we see an interest and a ctive investment by the relevant 
counterparts. The EU is fully committed to ensuring that the new system provides a higher level of 
patient protection and counts on trade partners to encourage their manufacturers to meet these 
new requirements to ensure tr ade continuity.  
2.1.3.23   China - Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61149) 
2.208.   The delegation of Brazil  provided the following statement. Brazil would like to once again 
raise STC 611 regarding new requirements for the registration of overseas producers of imported 
foods. So far, both bilaterally and at the TBT Committee, the Chinese Government has not been  able 
to clarify the risk analysis that grounded such disproportionate requirements for a wide range of 
food products. We understand that these requirements constitute unnecessary obstacles not only to 
our private sector, but also to our regulators, which must operate as the Competent National 
Authority for a much wider range of products. Not only are the regulators facing an unreasonable 
increase in their burden, but some of them must also make recommendations on products or 
producers that are actually sub ject to inspection by authorities of other levels of government. In 
April 2021, the General Administration of Customs of China (GACC) published Decrees no. 248 and 
249, which deal, respectively, with administration of registration of foreign establishments  and 
management of the safety of imported and exported food. Article 5 of Decree no. 248 requires that 
the food safety management system of the country where the producer is located has passed GACC's 
equivalence assessment or review. Could China explain ho w and when it intends to carry out these 
assessments? Could China indicate the criteria and procedures used to establish such equivalence, 
especially for regulators of processed foods and "health foods "? 
2.209.   The delegation of Australia  provided the following s tatement. Australia respects the right of 
WTO Members to address the safety and quality of imported food products in accordance with the 
TBT Agreement and without unnecessarily restricting trade. Australia would like to acknowledge 
China's recent implement ation of measures under its Regulation on Registration and Administration 
of Overseas Manufacturers of Imported Food (Decree 248). Australia notes that China is still 
managing the transition to the new measures and updates to China's registration systems a re 
occurring sporadically. Australia would like to request that China meets its obligations to provide 
Members with transparent timeframes for updates and appropriate guidance and assistance to 
support enterprises in meeting China's registration process an d minimise disruptions to trade or 
confusion at the border. Australia remains concerned over the burden imposed on competent 
authorities to administer changes within China's registration system. This burden is exacerbated by 
a number of issues, such as del ays and lack of clarity surrounding the registration of food enterprises 
within China's registration systems. This is causing significant industry concern and, for some 
commodities, is trade restrictive.  
2.210.   Australia reminds China that its regulations must no t be used to discriminate against 
imported goods and that delays in processing registration renewals and new applications from 
overseas food producers may lead to imported foods being treated less favourably than China's 
domestic product. Australia would a ppreciate China's transparency on timeframes for processing 
these applications, in line with its obligations under the TBT Agreement. Further, Australia would 
also like to raise concerns with the provision under Decree 248 which allows China to livestream 
audit foreign food facilities at short notice, threatening suspension for non -compliance. Australia 
encourages China to work with competent authorities and food facilities to conduct audits in an 
informed, sustainable and reasonable way. Australia urges Ch ina to address these issues promptly 
and remains willing to work with China to minimise trade disruptions.  
2.211.   The delegation of Canada  provided the following statement. Canada and other Members 
continue to raise significant concerns and challenges with China' s administrative measures for the 
registration of overseas manufacturers of imported food. Canada would like to refer to its previous 
interventions on this item, which remain valid. Canada continues to be concerned that the new 
administrative measures are overly burdensome and unjustified. These measures are broad and 
overarching in scope and will have a significant impact on Canadian exports to China. Canada notes 
that the implementation of the online China Import Food Enterprise Registration (CIFER) syste m, 
 
49 For previous statements follow the thread  under ID 611 . G/TBT/M/87  
 
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  which was not notified by China to the WTO, will create further barriers to trade including significant 
financial and resource impacts on both industry and foreign competent authorities. Prior engagement 
by China with trading partners could have limited  the disruptions and concerns being raised by 
competent authorities and industry stakeholders. Despite repeated requests from trading partners, 
there remains limited engagement, limited information, and minimal guidance from China Customs 
regarding the imp lementation of the CIFER system, which is resulting in continued uncertainty and 
concerns. As a result, exporters are now encountering delayed clearance of their shipments as 
companies are unable to register or update their registration in the CIFER system . 
2.212.   The registration process in the CIFER system is overly detailed and confusing, lacking a step -
by-step guidance and defined timelines for both competent authorities and industry. As many 
questions remain regarding the registration process, Canada calls on  China to create a single contact 
or enquiry point for both industry and competent authorities, or to work directly with companies for 
the completion of their registration. Additionally, Canada expects China to add to the CIFER system, 
without further dela y, all Canadian products and establishments previously approved by China, but 
currently not on China Customs' lists of approved Canadian products and facilities eligible to export 
to China. Canada strongly urges China to outline all timelines in a transpar ent manner and develop 
clear guidance documents to address the questions and concerns from both industry and competent 
authorities. Canada remains deeply concerned about the unnecessary impact these measures are 
having on trade. In conclusion, Canada calls  on China to provide Members with additional information 
and clarification on the new measures and the CIFER system in the very near future.  
2.213.   The delegation of the European Union  provided the following statement. The EU would like 
to reiterate its concerns regarding the implementation of Decree 248 of the General Administration 
of Customs of the People's Republic of China (GACC). The EU does not question the wish of China to 
ensure that imported food products come from legitimate sources. Overall, we share a nd support 
this objective. Whilst China has provided guidance information, and engaged in a dialogue with the 
EU, problems persist with the lengthy and burdensome mechanism set up by China to register 
exporting businesses, including: (1) cases of shipments  being held up at ports in China due to 
erroneous or missing information in the China Import Food Enterprise Registration (CIFER); 
(2) cases of establishments in the meat, dairy and fishery sector that were notified to GACC before 
the deadline of 31 Decemb er but remain unregistered; (3) the lack of clarity about the scope and 
category of products that are covered, which keeps expanding; and (4) the obligation put on 
competent authorities and businesses to consult CIFER, almost continuously, to be able to fo llow all 
the changes made by China to the structure of the CIFER system and to individual registrations, as 
well as to be informed about the deadlines to re -register individual establishments. Therefore, the 
EU urges China to: solve implementation issues p ragmatically and expeditiously; facilitate new and 
old registrations by continuing to provide supporting material, guidance documents in English, 
including on how competent authorities have to verify the establishments that were registered under 
the fast t rack procedure; facilitate amendments/corrections to existing registrations; and facilitate 
the management by competent authorities and businesses of the changes in CIFER, of the 
information requested by China and of the deadline to register establishments  by introducing an 
automatic e -mail notification system in CIFER. The EU would like to thank China for the openness 
and ongoing dialogue to solve the technical issues related to Decree 248, in particular the replies 
received on 1 July, which we are current ly reviewing. Important implementation issues remain and 
need to be solved in order to eliminate all disruptions to trade as soon as possible and before 1 July 
2023.  
2.214.   The delegation of Japan  provided the following statement. Japan shares the concerns raised  
by other Members on China's "regulations on registration and administration of overseas 
manufacturers of imported food ", published as Decree 248 on 1 January 2022. In particular, Japan 
understands that overseas manufacturers are prohibited from exporting food products without 
registration in accordance with Articles 22 and 23 of Decree 248, and remains concerned that such 
registration and administration procedures impose a heavy burden on overseas manufacturers as 
well as the competent authorities of WTO M embers. Japan, thus, requests that China minimize 
unnecessary burdens and improve the transparency of those procedures. In particular, Japan 
requests the following: First, China lessen the burden accompanying the procedures to register new 
facilities and t o correct the registered information afterwards, and allow for a smooth registration 
without undue delay when the competent authorities and manufacturers apply or nominate for 
registration pursuant to Articles 7 and 9 of Decree 248. China currently require s a wide range of 
documents and information which Japan believes is excessive, and the registration procedure 
sometimes takes a month or more to complete.  G/TBT/M/87  
 
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  2.215.   Second, China provide written notices to show the results of the registration examination 
pursuant to  Article 14, for example, by notifying the registration number in writing when the 
registration has been completed so that the applicant can easily understand the status of the 
procedure. Third, regarding the China International Trade Single Window system which the 
competent authorities and manufacturers are obliged to use when nominating and applying for 
registration: (i) China provide a detailed manual on how to use the system, particularly because the 
interface sometimes changes without prior notice; (ii ) add all product codes (HS ･CIQ) missing from 
the product code list shown on the system because the exported food product cannot be registered 
without a corresponding product code; (iii) enable competent authorities and manufacturers to 
change the name of the legal representatives and the addresses of the registered manufacturers 
while maintaining the current registration because, currently, a manufacturer is required to register 
again when the registered information changes out of necessity; and (iv) enabl e the submission of 
letters of proxy via the system, and confirm the validity and scope of the proxy rights when accepting 
an application pursuant to Article 9 of Decree 248 because electronic copies of the letters of proxy 
cannot be uploaded via the syste m, and China does not scrutinize the legality of proxy rights to 
prevent applications made by unauthorized persons.  
2.216.   We request that China address these concerns mentioned above, and provide appropriate 
explanations, time frames, and detailed guidelines on the operation of Decree 248, as well as the 
registration system, and answer any questions from Japan which remain unanswered. Lastly, even 
though Decree 248 entered into effect on 1 January 2022, in order to avoid unnecessary burdens 
while China strives to  improve the transparency of those procedures, Japan requests that China 
(i) adopt a grace period and allow registered facilities to export items regardless of registration per 
item until 1 July 2023, and (ii) establish a point of contact for interested pa rties and competent 
authorities.  
2.217.   The delegation of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. Given the wide range of our food industries that have been or may 
have been affected by this measure, th e Separate Customs Territory of Taiwan, Penghu, Kinmen 
and Matsu has been closely following the implementation of the measure. Many concerns over the 
measure remain even after it took effect on 1 January 2022. First, the lack of sufficient information 
about registration requirements, operational guidelines, and updates of the stages of the procedure 
is one of the biggest difficulties we face. This issue is even more critical for those facilities that need 
to file the application by themselves. Without suffi cient guidance, the facilities are unable to complete 
registration, and trade may be disrupted as a consequence. To avoid trade disruption, we urge China 
to designate an Enquiry Point that can provide effective and timely assistance for facilities to conta ct 
directly with concerns about the online registration system. Also, we urge China to hold an 
information session in the WTO for trade partners to learn more about the General Administration 
of Customs of China (GACC)'s implementation of the measure.  
2.218.   Second, there are also concerns over the measure's review and approval procedure. 
Standard or anticipated processing periods are unknown. So is the stage of the application. In 
addition, some of our facilities were rejected by the GACC without further explanat ion, while others 
cannot correct their application in the registration system. Under Article 5.2.2 of the TBT Agreement, 
Members shall ensure that the standard processing period of each conformity assessment procedure 
is published to the applicant and, upo n request, the applicant is informed of the stage of the 
procedure. We request that the GACC comply with the requirements set out under the TBT 
Agreement, including the transparency requirement and informing the applicant in a precise and 
complete manner o f all deficiencies and allowing corrective actions. Third, other difficulties we face 
include the ambiguity of HS code categorization and the scope of the products subject to this 
measure. Some of our facilities reported that their products have faced cust oms clearance 
suspension for no reason.  
2.219.   Ever since China made notification to the WTO in 2020, we have expressed our concerns 
and sought clarification from China several times through both bilateral channels and this forum; 
however, we have yet to receive a sufficient and detailed response from China. We therefore once 
again urge China to offer sufficient and detailed guidelines and designate an Enquiry Point. Also, as 
any measure of this magnitude requires far more time for industries to implement, we urge  China 
to offer a longer grace period for implementation so as to avoid serious trade disruption. We also 
suggest that China temporarily allow entry of all products from registered facilities. This additional 
time will allow facilities to accurately enter or update the product information in their online 
registration.  G/TBT/M/87  
 
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  2.220.   The delegation of the United States  provided the following statement. The United States 
remains deeply concerned with this measure, published as Decree 248 on 12 April 2021, and 
implemented on  1 January 2022, and continues to question the food safety and public health 
benefits, and whether such benefits are based on science or risk. The United States notes that the 
lack of guidance provided by China and China's implementation and enforcement of  the measures 
continues to cause considerable confusion for exporters and competent authorities. The changing 
application of these administrative measures is directly leading to disruptions in trade. US agencies 
continue to face administrative burdens as t hey work to resolve issues with shipments held up at 
ports in China.  
2.221.   We reiterate statements raised in every meeting of this Committee since February 2020: 
any measure of this magnitude requires far more time for producers, exporters, and competent 
authorities to implement. Therefore, we again ask that China take the following steps to facilitate 
trade: First, the General Administration of Customs of China (GACC) should continue to use existing 
government -to-government facility registration  processes, as outlined in Article 11 of Decree 248, 
and not require facilities to enter information online, where such pre -established processes exist. 
Second, allow entry of all products from registered facilities without requiring extensive registration  
information or competent authority intervention for modifications. Third, provide a central point of 
contact at GACC for facilities to contact directly with concerns about the online registration system. 
Facilities should be able to communicate with this point of contact in English from outside of China, 
and the point of contact should not refer general registration questions to satellite GACC offices at 
individual ports. Fourth, hold an informational session in Geneva for trading partners to learn more 
about GACC's implementation of the Decrees.  
2.222.   We note that GACC's requests for additional detailed information from facilities and 
competent authorities, such as process -specific food safety plans and photographs on an 
establishment -by-establishment basis, cre ate additional administrative burdens for exporters and 
may possibly be unnecessary or unjustified. We look forward to China's response to these specific 
requests and comments.  
2.223.   The delegation of the Republic of Korea  provided the following statement. The R epublic of 
Korea supports Brazil, Australia, Canada, the European Union, Japan, Chinese Taipei, and the United 
States in raising this Specific Trade Concern. Korea respects China's efforts to ensure consumer 
safety and appreciates China for continuing bila teral cooperation. However, Korea would like to once 
again express our concerns under this STC, as China did not duly address the concerns that various 
Members including Korea have raised regarding Decree 248, which was promulgated on 12 April 
2021. To mee t the General Administration of Customs (GACC)' requirements, Korea put efforts to 
register the newly added product categories under Article 7 of Decree 248. However, the GACC's 
measures is creating unnecessary obstacles to trade because it is taking consi derable amount of 
time for the registration to finalize. While Korea respects the policy objective of Decree 248, we 
would like to ask China to streamline or expedite its registration process. Moreover, we suggest that 
China take a more efficient and pragm atic approach with its measures by allowing companies of the 
product categories outlined in Article 7 to register their respective establishments on the GACC 
website. For the purpose of ensuring transparency, Korea would like to express our concern that 
China did not allow a reasonable time period between its notification date and the date of which the 
regulation entered into force. As China's new measures is significantly affecting bilateral trade, we 
would like to ask China's response to Korea's requests.  
2.224.   The delegation of Türkiye  provided the following statement. With regards to the current STC, 
we reiterate our support to the Members that brought this item to the agenda. We believe that China 
as other Members has the right to take necessary measures to e nsure food safety as well as prioritize 
the protection of human health and safety. At the same time, those measures should not create 
unnecessary obstacles to international trade. We observe that Decree 248 covers a wide range of 
food items and the impleme ntation still need further clarifications. We think that this practice, which 
does not classify products based on a risk assessment, in fact does not fully meet the human health 
concerns targeted by this legislation. Therefore, we ask China to review the l ist of items in a more 
risk-based approach, and if it is possible only include items that are high -risk products. On the other 
hand, the regulation of the overseas importer's registration process imposes a great burden on both 
the exporters and the compete nt authorities of the exporting countries. The companies which are 
exporting the selected food items mentioned in the Decree 248 are expected to register by 
submitting necessary information. These companies might need a transition period to complete their 
registration with accurate information, and in some cases to update their applications. We think that G/TBT/M/87  
 
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  the companies' registration should be treated in a more flexible approach and might be granted for 
an extra time. Therefore, we ask for a grace period not  less than 18 months. Türkiye believes that 
this aforementioned regulation seems to be restricting trade more than necessary. Therefore, 
Türkiye would like to ask China to review this legislation from a risk -based perspective and narrow 
its scope of produc ts, in addition to extend the grace period for this regulation.  
2.225.   The delegation of Switzerland  provided the following statement. Switzerland shares – and 
supports – the concerns expressed by other Members regarding decrees 248 and 249 published by 
the Gener al Administration of Customs of the People's Republic of China (GACC). Switzerland 
supports China's objective to ensure that only safe food is imported. However, we regret that the 
measures still include all food categories irrespective of their risk -profile and seem to be more trade 
restrictive than necessary to ensure the safety of imported food products. We therefore reiterate our 
concerns expressed in previous meetings. Furthermore, Switzerland strongly encourages China to 
allow entry of all products fr om registered facilities until 1 July 2023. This additional time would 
enable facilities to accurately enter or update product information in their online registration.  
2.226.   The delegation of Mexico  provided the following statement. The delegation of Mexico onc e 
again refers to Decree 248, notified to the Members of this Committee on 16  November  2020 in 
document  G/TBT/N/CHN/1522, which entered into force on 1  January  2022. While efforts have 
begun to ensure that the registration of Mexican companies exporting to  China is carried out in a 
satisfactory manner, we have identified that concerns remain about potential effects on international 
trade, since we have been made aware of recent issues in the process for the registration of Mexican 
companies. In this connect ion, we reiterate how important it is for the measures adopted by 
Members of this Committee to comply with the international commitments contained in the TBT 
Agreement. We also ask the delegation of China to provide a point of contact that may offer 
assist ance to companies that have experienced difficulties in registering. Lastly, the delegation of 
Mexico thanks the delegation of China for giving its consideration to this statement.  
2.227.   The delegation of Chile provided the following statement. The delegation of  Chile appreciates 
the opportunity to address this specific trade concern and would like to refer to what was said on 
the matter in the Committee on Technical Barriers to Trade last March.  
2.228.   In response, the delegation of China  provided the following stateme nt. 1. The revision of the 
Draft Administrative Measure for Registration of Overseas Producers of Imported Foods is based on 
law, the process is open and transparent, and complies with international rules and common 
practices. GACC has made amendments to t his measure and notified to WTO, provided Members 
with a commenting period, fully considering Members' comments, and followed the requirement of 
the transitional period. 2. While aiming to strengthen food safety supervision, the measure also 
takes full con sideration of trade facilitation. All categories of food specified in the Food Safety Law 
are included, among which, "official recommendation registration" is adopted for the overseas 
production enterprises of 18 categories of food, while "self -application  by enterprises" with relatively 
simplified procedures is adopted for the overseas production enterprises of food other than the 18 
categories.  
2.229.   China welcomes the suggestions for China to offer more clarifications as to the 
implementation of the measure. A s a matter of fact, a lot of preparation works have been carried 
out in this direction. 3. To ensure the smooth implementation, GACC has issued the rules of 
interpretation, the guide for registration applications, supporting documents and forms for 
registr ation applications, and the operation manual for a registration information system. In 
September 2021, China contacted Members which exported food to China, informed them of the 
relevant requirements and procedures for the registration of overseas enterpri ses, and made 
reasonable arrangements to speed up the auditing process. As for the implementation of the rules, 
the GACC has been in close contact with the competent authorities of various Members and other 
relevant parties. GACC answered their concerns ab out registration through video conferences, 
telephone calls, emails and letters. GACC has held video -conference with 152 Members, organized 
training for more than 2,000 overseas enterprises through industry associations, and answered all 
the questions of o verseas relevant parties. 4. Since the implementation of the regulations, by the 
end of June of 2022, more than 100 Members have provided the list of enterprises recommended 
for registration, a total of 73,743 overseas manufacturers engaged in 32 food cate gories are 
registered. Right now, according to our observation, the implementation of this measure is going in 
an ever smoother way.  G/TBT/M/87  
 
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  2.1.3.24   India – Toys (Quality Control) Order, 2020 (IND/131); Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2 017- Schedule -I (Import Policy) 
(IND/143), G/TBT/N/IND/68 , G/TBT/N/IND/131 , G/TB T/N/IND/143  (ID 63250) 
2.230.   The delegation of the European Union  provided the following statement. As stated in previous 
TBT Committees, the European Union is concerned about India's Toys Quality Control Order (QCO) 
and in particular the certification requireme nts introduced by the Bureau of Indian Standards (BIS). 
The EU refers to its previous statement but would like to highlight that European industry continue 
to report the difficulties to work through the QCO. Since its adoption in 2021, the European 
compani es are facing serious challenges especially because of the factory inspection requirement to 
obtain the necessary BIS marking. In order to comply with the regulatory order, the European 
companies have submitted the necessary applications well in time to fu rnish Indian authorities with 
the necessary information to enable factory audits by BIS auditors. However, factory audits were 
not performed. Only recently, the European industries are experiencing some improvements thanks 
to more travel possibilities for factory certifications, and we appreciate that from India. However 
they indicate that the QCO remains challenging and the process is still very burdensome and 
complex. In addition, a huge concern is related to the fact that the import policy (G/TBT/N/IND/143 ) 
is being applied on to p of the QCO.  
2.231.   The EU would like to recall that on -site factory audits and verification testing requirement is 
burdensome, expensive and unnecessary. Also, without any alternative, the requirement for the 
QCO is inconsistent with international product safet y practices. The European Union invites India to 
address the concerns raised and to alleviate the requirement for factory audits overseas. The 
European Union remains available to have bilateral exchanges to find an adequate solution.  
2.232.   The delegation of the United States  provided the following statement. The United States 
supports and echoes the statements made by other Members on this STC. In the last four WTO TBT 
Committee meetings, the United States has urged India to provide a means by which US companies 
can resume shipments of toys to India. We note the inability to secure factory inspections required 
by a Quality Control Order (QCO) is not unique to the toy industry. At the March meeting, we heard 
other Members report that companies in industries includi ng chemicals, paper, and automotive face 
the same barrier shipping goods to India. The last shipment of toys to India by a US company was 
nearly two years ago and if inspections of toy factories do not begin immediately, US companies are 
unlikely to ship a ny toys to India in 2022. In light of repeated confirmations from India that toy 
products produced by US -based entities are not the source of safety concerns, we urge India to 
consider means by which US companies can comply with the QCO without further del aying US 
companies' exports of toys to India.  
2.233.   The delegation of Canada  provided the following statement. As stated in previous TBT 
Committees, Canada continues to remain unclear regarding the objective of India's requirement that 
toy manufacturing sites be  inspected by the Bureau of Indian Standards personnel to verify, among 
other things, production processes and plant layout, and to collect product samples. India has 
previously stated that its main concern is safety of toys and that many "foreign " toys in India failed 
a safety test and electrical inspections. However, Canada continues to question the necessity of 
inspecting toy manufacturing facilities to ensure toy safety. Could India please provide a rationale 
how inspecting the toy manufacturing  sites is going to demonstrate that the health and safety 
requirement of a toy is met? And if the purpose of the factory inspection is in fact product testing, 
what would be India's rationale for not allowing this testing to be done by International Labora tory 
Accreditation Cooperation (ILAC) accredited labs? The Canadian industry continues to raise great 
concerns with India's compliance requirements for the Quality Control Order. Recently the industry 
has reported that while some factory audits are happeni ng overseas and the shipment of toys has 
resumed, Indian officials are still testing at the ports of entry in addition to the testing at the 
factories. Could India please provide a rationale for the necessity of this double testing requirement 
of products?  
2.234.   Canada would like to reiterate that the on -site factory audits and verification testing 
requirement is onerous, unnecessary, and expensive. And failure to provide alternatives is 
inconsistent with international product safety practices such as ISO 17067. Additionally, verification 
and testing must be performed by a lab accredited by the Indian accreditation body, only a few of 
which exist outside of India. In contrast, international safety norms allow product testing to be done 
 
50 For previous statements follow the thread under ID 632 . G/TBT/M/87  
 
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  by any laboratory accredited  to international standards by an accreditation body that is an ILAC -
MLA signatory. Further, because costs of the on -site audit, including travel to and from the factory 
by Indian government auditors must be paid by the manufacturer, the on -site audit requ irement 
treats domestic manufacturers more favourably than foreign ones. Canada kindly urges India to 
consider allowing product testing to be done in the country of manufacture by ILAC -accredited labs 
and to remove the requirement for factory audits overse as. Canada looks forward to working with 
India to ensure access to safe, high -quality toys from Canadian firms.  
2.235.   In response, the delegation of India provided the following statement. As per the provisions 
of the QCO, the products specified therein shall be ar a Standard Mark under a valid licence from BIS 
as per Scheme -I of the BIS (Conformity Assessment) Regulations, 2018. Under this Scheme, factory 
inspection is a mandatory requirement for the purpose of granting of licence. As per the product 
certificatio n scheme of BIS, the availability of in -house testing facilities with manufacturers is 
required to operate a licence. However, BIS has allowed relaxations for toys manufacturers, including 
permitting sub -contracting of tests to BIS -recognized laboratories.  As per the product -specific 
guidelines for toys, sub -contracting of tests other than physical, mechanical and electrical safety is 
allowed. Sufficient capacity for testing of toys is available in BIS laboratories and laboratories 
recognized by BIS under i ts laboratory recognition scheme (BIS LRS) for testing as per the relevant 
Indian Standards. Clause 12 of BIS LRS deals with the recognition of overseas laboratories. The 
decision regarding recognition of overseas laboratories will be taken by BIS taking i nto account the 
MRA (Mutual Recognition Agreement) with the concerned nation. Foreign inspections were on hold 
due to the prevalent restrictions on international travel imposed. As the COVID -19 restrictions have 
eased out, BIS has started carrying out insp ection where confirmation for travelling of fully 
vaccinated BIS officers has been received. BIS has nominated officers and applicants are asked to 
remit the inspection charges for carrying out inspection. On receipt of inspection charges, inspections 
are being planned. Preliminary inspection for more than 100 applications has already been carried 
out. However, in some cases inspection are being delayed due to difficulty in issuance of VISA.  
2.1.3.25   European Union - Non-renewal of the approval of the active substan ce 
mancozeb, G/TBT/N/EU/712  (ID 62751) 
2.236.   The delegation of Brazil  provided the following statement. Brazil would like to convey once 
again its concerns regarding the non -renewal of the approval of the active substance mancozeb, 
according to European TBT notification G/TBT/N/EU/712 . Mancozeb is a substance whose u se 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 sig nificantly 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 
chloroth alonil. Mancozeb is an important substance for the management of fungicide resistance to 
control soybean rust. It is used as a crop protection additive, intended to increase the effectiveness 
of other fungicides, minimizing resistance, and prolonging the l ife cycle of other molecules. In light 
of the insufficient transitional period granted by the EU, such crops could not have their treatments 
changed in time for exportation to the EU market before the entry into force of the regulation. Brazil 
would like t o urge European authorities to consider establishing transition periods that are adequate 
to the production cycle of the affected crops. Brazil also respectfully asks the EU to align MRLs with 
limits established under the framework of Codex Alimentarius, t o consider less trade -restrictive 
alternatives that would also safeguard its legitimate policy objective and to grant a treatment for 
Brazilian farmers no less favourable than that granted to European farmers.  
2.237.   The delegation of Colombia  provided the follow ing 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. As we have already 
noted, the EU has adopted measures resulting i n the non -approval of the use of plant protection 
products, which is affecting exports from Colombia. Measures on the suspension or non -approval of 
the marketing of numerous active substances and the subsequent reduction of their MRLs to the 
minimum detect ion limit are being taken without any sound scientific evidence and without proof 
that such measures are the least trade -restrictive means of achieving an appropriate level of 
protection. We have already referred to the importance of this plant protection substance on previous 
occasions. In this connection, we would like to ask the EU to provide clarification on the relationship 
 
51 For previous statements follow the thread under ID 627 . G/TBT/M/87  
 
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  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 substances that are 
carcinogenic, mutagenic and toxic for reproduction. 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 
the adoption of the standard and on the implementation of max imum residue limits, the EU has 
failed to respond to these requests.  
2.238.   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 force in 
order to allow time for producers in exporting Members, and particularly in developing country 
Members, to adapt their products or methods of production to the requirements of the importing 
Member". In line with the above, the information available indicates  that EFSA has initiated the 
procedure for revising MRLs for mancozeb and similar substances. In the previous Committee, the 
EU indicated that the scientific opinion would be published in the first half of 2022. In this regard, 
and taking into account that  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 a conveniently early stage and to take into due account 
Members' comments, in line with Article 2.9. We also request that this Committee be informed of 
the steps to be taken in such cases. In this case, too, producers and exporters have questions and 
concerns regarding inspection and control mechani sms and procedures. The EU has failed to provide 
clear answers on how to make carrying out foreign trade operations more predictable, on inspection 
mechanisms, or to demonstrate compliance with requirements. Lastly, we once again invite the EU 
to follow th e recommendations for good regulatory practices, under which standards must be based 
on clear and objective information, and which promote open dialogue with stakeholders, 
transparency and the minimizing of market distortions.  
2.239.   The delegation of Paraguay  provided the following statement. This concern and the non -
renewal of the approval of the remaining substances were already discussed extensively both in this 
Committee and in the SPS Committee because of the subsequent reduction in the MRLs. Paraguay 
theref ore refers to its previous statements and reiterates its cross -cutting concern with regard to 
the EU's decision not to renew the approval of these substances without a proper risk analysis and 
without complying with scientific principles. We draw attention  to the most recent emergency 
authorization of this substance. As with previous emergency authorizations, the applicant country, 
in this case Finland, presents the same arguments as Paraguay and other Members in favour of the 
use of this substance: the lac k of available alternatives for protection against some pests, the 
importance of mancozeb to avoid problems with resistance, and in general, the production and 
financial losses caused by some pests that can be combated effectively only using this substance . 
What the emergency authorization does not mention is the large number of fungi against which this 
fungicide is used and how prevalent most of these are in countries like Paraguay that have climatic 
conditions and pest -pressure levels that are very differ ent from those in the European Union, and 
that these fungi can be safely and effectively controlled by substances such as mancozeb.  
2.240.   We have already heard the EU say that the measures are only in place for 120 days, but we 
recall that there is no limit to t he number of times that they can be renewed. Emergency 
authorizations are not intended to facilitate trade, unlike import tolerances, but we have not received 
answers to repeated written questions, submitted on numerous occasions, on the specific 
mechanism s used to ensure that products with temporary MRLs are kept within the borders of the 
authorizing Member and on the consistency between this authorization and the alleged concerns 
about the food safety impact of using these substances, in relation to which  we note not only the 
discrimination that exists in practice between EU producers and trading partners but also an 
inconsistency between the legitimate objective pursued and the actions taken to achieve it.  The EU 
also mentions in its responses, such as t hose contained in document G/SPS/GEN/2038 , that 90% of 
emergency authorizations are granted for products approved for use in the EU, and that most of 
these are covered by existing MRLs, but our questions seek clarity on those that are not.  
2.241.   We also heard that emergency authorizations "are used only where it is necessary to do so 
because of a danger or threat to plant production or ecosystems which cannot be contained by any 
other reasonable means". We agree with this statement, but unfortunately the lowering of MRLs for 
this and other substances by one of the world's largest food importers leaves our producers and 
those of other Members without possible quick fixes like the emergency authorizations available to 
EU Members. Paraguay shares the objectives that the EU seeks to meet with th ese policies but does 
not share its adopted method for attaining them because it is not based on conclusive scientific G/TBT/M/87  
 
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  evidence and does not consider less trade -restrictive options or valid alternatives for hazard control, 
which do not exist in this case, as the EU agrees by granting emergency authorizations to its 
Members. We reiterate our question on how the Members concerned by the process can participate 
in the analysis that the European Food Safety Authority (EFSA) is conducting on the MRLs for 
mancoze b, on the current status of the analysis, since an outcome was expected in the first half of 
this year, and on how comments submitted by Members will be taken into account. We are also 
seeking detailed responses to the queries regarding emergency authoriza tions that were raised in 
the SPS Committee and were not satisfactorily answered with the statement that granting or refusing 
such authorizations "is the responsibility of the EU member States". Lastly, Chair, we cannot fail to 
recognize the extraordinary efforts that the EU is making in the bilateral/plurilateral and multilateral 
spheres, including through dual notifications (TBT/SPS). However, what my country and my 
country's producers need is not a unilateral explanation of the measures but a frank dialo gue that 
allows the legitimate demands we are making to be met while at the same time achieving the EU's 
legitimate objectives in the least trade -restrictive way possible, in compliance with the rules and 
principles of the multilateral trading system.  
2.242.   The delegation of Australia  provided the following statement. Australia recognizes the 
European Union's right to regulate the manufacture and use of plant protection products in 
agriculture to address risks unique to its settings. However, Australia reiterates  its 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 notes the EU has 
recently made several plant protection prod uct non -renewal decisions and subsequent changes to 
relevant MRLs which are impacting Australia's trade with the EU. We seek further clarification on 
how this decision will impact future decisions around MRLs. In particular, we understand the 
European Food  Safety Authority (EFSA) has been reviewing the existing MRLs for dithiocarbamates, 
and we welcome any information on EFSA's scientific opinion, which was expected to be published 
in the first half of 2022. Australia notes that our competent domestic autho rity and Codex have 
determined MRLs for dithiocarbamates that ensure the continued protection of human, animal and 
environmental health while allowing trade to continue.  
2.243.   The delegation of Costa Rica  provided the following statement. Costa Rica wishes to ex press 
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. We support the statemen ts of the delegations that have already 
taken the floor.  
2.244.   The delegation of Chile provided the following statement. The delegation of Chile echoes 
what was recently presented in the room. The active substance Mancozeb is of great importance for 
Chilean agriculture and, given that Mancozeb does not have a replacement product of similar 
effectiveness and characteristics, the non -renewal of authorization by the EU is of great concern to 
our agricultural export sector.  
2.245.   The delegation of Ecuador  provided the following statement. Ecuador reiterates its concern 
regarding the non -renewal of man cozeb. As we have already mentioned on previous occasions, this 
fungicide is used for many strategic crops produced in Ecuador and the region, including bananas, 
cocoa and broccoli.  This compound is important for pest management in countries with tropical climates 
– like Ecuador – in which pest behaviour follows patterns that are very different from those prevailing 
in countries with four seasons, meaning that chemical pesticides for agricultural use that have 
mancozeb as their active ingredient are vital f or agricultural production.  I must point out that the 
way in which this substance is applied in banana production means that the use of mancozeb is the 
most effective and environmentally friendly phytosanitary control method for Black Sigatoka, bearing 
in mind that the latter is considered to be the most destructive disease for banana and plantain 
crops; it is thought to pose the highest economic risk for such crops and can cause yield losses of 
up to 50 %. Ecuador is concerned that there are currently no ap proved and properly registered 
alternatives to this substance that are as effective as mancozeb. As a result, prohibiting the use of 
mancozeb  – without effective alternatives – could have a very significant economic impact on 
small -, medium -, and large -scale producers in my country.  
2.246.   Ecuador urges the EU to take into consideration the relevant scientific information emanating 
from international specialized agencies recognized by the WTO, such as the Codex Alimentarius, 
which has information relating to this substance.  We would like to recall that the economies of Latin 
American countries have not yet recovered effectively from the impact of the COVID -19 pandemic, G/TBT/M/87  
 
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  which has led to a reduction in the agro -export supply markets of these countries. Therefore, 
continuing to suspend the use of compounds solely on the basis of the precautionary principle will 
result in a loss of production and obstacles to the marketing of products, further affecting the already 
hard-hit economies of countries such as E cuador.  For these reasons, Ecuador calls on the EU to 
consider alternative measures that are less trade -restrictive, to identify substitute substances that 
would enable existing trade to continue, to base its measures on conclusive studies, not only the 
precautionary principle, and to establish transition periods of at least 36 months for the registration 
of alternative substances, in view of the current shortage of tools available to control pests.  
2.247.   The delegation of Uruguay  provided the following statement . Mancozeb is an active 
substance that is authorized and widely used in a safe manner in many countries, including Uruguay, 
for the control of diseases and pests in various national fruit and vegetable sector products, including 
apples, pears and citrus fr uits. 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 o ther delegations, 
particularly with respect to the possibility that, as a result of the ongoing dithiocarbamate review 
process, the European Union may significantly reduce the corresponding MRLs, even lowering them 
to the limit of determination, without ha ving any conclusive scientific evidence that substantiates 
such a decision in line with the WTO SPS Agreement. We would appreciate an update of the current 
status of the ongoing review process of these substances, including the expected date of completion,  
the reasons for the apparent delay and the date on which a notification of the changes to the MRLs 
might be submitted to the SPS Committee. Against this backdrop, like other Members, Uruguay 
recalls the importance of taking due account of international st andards, guidelines and 
recommendations and the scientific information produced by international standard -setting bodies 
recognized at the WTO, such as the Codex Alimentarius, and of allowing a reasonable transition 
period if a decision is made to change t he MRLs.  
2.248.   The delegation of Argentina  provided the following statement. Argentina maintains its 
general concern regarding the hazard -based approach used by the EU as regards regulating 
pesticides, without identification of risk, which is an unnecessary tech nical barrier to trade.  In the 
case of mancozeb, this is a broad -spectrum fungicide used for growing fruits, vegetables and field 
crops.  Although Argentina shares the EU's concern over strengthening the protection of human 
health and the environment, we wo uld once again like to underline the importance of complying with 
Articles 2.2 and 2.4 of the TBT Agreement, which stipulate that "technical regulations shall not be 
more trade restrictive than necessary to fulfil a legitimate objective".  We are particular ly concerned 
by the number of substances banned by the EU Commission, which has been increasing with each 
passing day. This situation may have serious consequences for various WTO Members, particularly 
developing countries, whose populations and economies are highly dependent on agricultural 
exports.  It is therefore crucial for the EU to use a risk assessment approach in the analysis of these 
regulatory changes and to have conclusive scientific studies to determine the various aspects that 
may affect human health and the environment.  
2.249.   In response, the delegation of the European Union  provided the following statement. We 
have provided detailed explanations on this issue in previous TBT Committees. On 17 April 2020, 
the European Union notified to the TBT Commit tee 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 (the "EU 
Plant Protection Products Regulation ").52 Implementing Regulation (EU) No 2087/202053 entered 
into force on 4 January 2021. The non -renewal was based on a scientific assessment conducted 
under the EU Plant Protection Products Regulation by experts from the EU member States  and the 
European Food Safety Authority (EFSA). Since EFSA concluded that Mancozeb did not meet the 
approval criteria as outlined in Article 4 of Regulation (EC) No 1107/2009, the approval of this 
substance was not renewed. EU member States had to withdraw  existing authorisations for plant 
protection products containing Mancozeb at the latest by six months from the date of entry into 
 
52 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the pla cing of plant protection products on the market and repealing Council Directives  79/117/EEC 
and 91/414/EEC. OJ L 309 24.11.2009, p. 1.  
53 Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non -
renewal of the approval of the  active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending the Annex to Commission Implementing Regulation (EU) N o 540/2011, OJ L 423, 
15.12.2020, p. 50.  G/TBT/M/87  
 
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  force of the Implementing Regulation (by 4 July 2021). Possible grace periods granted by EU member 
States, in line with Artic le 46 of Regulation 1107/2009, expired, at the latest, on 4  January 2022, 
after 12 months from its entry into force.  
2.250.   The EU would like to inform Members that EFSA has started a review of the existing Maximum 
Residue Levels (MRLs) for dithiocarbamates (grou p of substances of which Mancozeb is part). We 
informed Members at the last TBT Committee meeting that interested parties had been invited to 
actively contribute with relevant information to this MRL review through the main authorisation 
holder, as describ ed in document G/SPS/GEN/1494/Rev.1 .54 The EFSA scientific opinion on 
dithiocarbamates is expected to be published in the second half of 2022. For advice on alternatives 
to Mancozeb, the EU pesticides database55 is publicly available and contains information on all active  
substances, their approval status and their main purpose (e.g. fungicide, insecticide or herbicide). 
Independently of the situation under the EU Plant Protection Products Regulation, use restrictions of 
Mancozeb have been introduced under the EU Chemicals  legislation (REACH56), following the 
classification of the substance as CMR (carcinogenic, mutagenic or reproductive toxicant) 1A or 1B 
under that same Regulation.  
2.1.3.26   India - Quality Control Orders for Chemical and Petrochemical Substances, 
G/TBT/N/IND/116 , G/TBT/N/IND/121 , G/TBT/N/IND/122 , G/TBT/N/IND/123 , 
G/TBT/N/IND/124 , G/TBT/N/IND/125 , G/TBT/N/IND/126 , G/TBT/N/IND/127 , 
G/TBT/N/IND/128 , G/TBT/N/IND/129 , G/TBT/N/IND/130 , G/TBT/N/IND/132 , 
G/TBT/N/IND/133 , G/TBT/N/IND/134 , G/TBT/N/IND/135 , G/TBT/N/IND/136 , 
G/TBT/N/IND/137 , G/TBT/N/IND/138 , G/TBT/N/IND/139 , G/TBT/N/IND/140 , 
G/TBT/N/IND/141 , G/TBT/N/IND/142 , G/TBT/N/IND/144 , G/TBT/N/IND/150 , 
G/TBT/N/IND/151 , G/TBT/N/IND/152 , G/TBT/N/IND/153 , G/TBT/N/IND/154 , 
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 , 
G/TBT/N/IND/201 , G/TBT/N/IND/202 , G/TBT/N/IND/203 , G/TBT/N/IND/204 , 
G/TBT/N/IND/205 , G/TBT/N/IND/206 , G/TBT/N/IND/208  (ID 63057) 
2.251.   The delegation of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to reiterate its concerns about the Order issued by India's Ministry of Chemicals 
and Fertilizers on phthalic anhydride and n -butyl acrylate, a nd terephthalic acid, which were notified 
by 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 the products concerned until 22 December 2022. Secondly, 
given that the pandemic will not likely end in the short term and it is still difficult to conduct on -site 
inspections under the current situation, we would like to urge India to postpone the implementation 
of above -mentioned products once again. In addition, we still suggest that India implements 
alternative measures during the pandemic regarding all pro ducts concerned, such as allowing testing 
laboratories and inspection bodies from other WTO Members to participate in the conformity 
assessment procedures and accepting their reports or remote factory inspection, to address the 
difficulties of physical ins pection resulted from international travel restrictions.  
2.252.   The delegation of the United States  provided the following statement. As of July 2022, India's 
Ministry of Chemicals and Fertilizers notified 44 Quality Control Orders (QCOs) 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 compliance to standards 
set by the Bureau of Indian Standards. In particular, we continue to highli ght US industry's concerns 
regarding the Polyethylene Material for Moulding and Extrusion (Quality Control) Order, 2020 
(Polyethylene QCO), notified as G/TBT/N/IND/191 . While we appreciate the Ministry's delay of the 
Polyethylene QCO's enforcement date, US industry remains concerne d about the measure's labelling 
requirement, which mandates the marking of the smallest unit -level package of polyethylene product 
 
54 
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/GEN1494R1.pdf&Open=True   
55 https://ec.europa.EU/food/plant/pesticides/eu -pesticides -db_en   
56 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registr ation, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a 
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Dir ective 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
57 For previous statements follow the thread under ID 630 . G/TBT/M/87  
 
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  delivered to the customer. Under this requirement, these markings must include "designation codes" 
identifying an array of te chnical information, including a product's melting point, density, processing 
method, and application. Can India explain the intended objective and audience for these new labels?  
2.253.   We reiterate US industry's comments that other markets have neither applied s uch labelling 
requirements to polyethylene products nor experienced any perceived need for such information, 
given the technical knowledge of the customers involved in the commercial transaction. We remain 
interested in hearing how India has considered ind ustry input on alternative, cost -effective, and 
mutually beneficial ways to fulfill India's regulatory objectives. How has India considered these 
proposed alternative options? We continue to report US industry's concern that, as proposed, 
requiring the lab elling and affixation of information in print, with alphanumerical code unique to 
India, on either the polyethylene product's bag or its smallest unit -level packaging delivered to the 
customer will impose administrative burdens leading to inefficiencies, d elays, and additional costs 
for exporters. We are concerned about possible confusion on the part of the Indian customer in 
deciphering the code as the product moves through the chain of custody, as well as confusion on 
the part of any third country custome r to whom such labelled products might be exported to from 
India. Given Indian dependence on imports, particularly with regard to specialty grade resins, such 
labelling may disrupt Indian imports of, and access to, essential materials used by Indian health  
care, pharmaceutical, and other high value Indian export -critical sectors.  
2.254.   The delegation of the European Union  provided the following statement. The European Union 
would like to support the delegations of the United States and Chinese Taipei. India conti nues to 
define and introduce specific standards and certification requirements for a number of products – 
under the umbrella of the Quality Control Orders (QCOs). The QCOs require physical audit at 
manufacturers' premises by an auditor of the Bureau of Ind ian Standards (BIS) in order for products 
manufactured in third countries to receive the approval for exports to India. The EU deeply regrets 
that India repeatedly refused to consider meaningful alternative options to foreign audits – which 
were suspended for over two years due to the SARS COV -2 pandemic - such as virtual audits or 
audits conducted by internationally recognized third agencies/entities. The EU welcomes the fact 
that applications for inspections are processed gradually. However, the EU would like to stress the 
benefits that virtual audits and recognition of laboratories outside India would have for India and its 
partners. It would further help BIS in reducing its backlog of pending applications. The EU would 
therefore like to take this opportu nity to request Indian authorities to consider preparing rules for 
international recognition of laboratories by the BIS, as foreseen by legislation in place. This would 
speed up audits, and lower the cost of mandatory testing for foreign manufacturers.  
2.255.   The EU would like to reiterate its stance that the QCOs in question have a protectionist 
orientation. The increasing number of QCOs across sectors is sending worrying signals to EU 
industry, EU investors, and EU member States. Once these QCOs 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 for products already certified under established 
international standards. Furthermore, the fo reign manufacturers have to make necessary 
modifications in their tooling systems for the ISI mark, which could cause temporary shutdown of 
some production lines. In this context, the QCOs add little value for Indian consumers, making the 
reason of their i ntroduction not evident. Quality Control Orders pertain to a wide range of chemical 
and petrochemical products under the HS chapters 28 and 29. The EU systematically takes note of 
all Indian TBT notifications pertaining to Quality Control Orders (QCOs) for  chemical and 
petrochemical substances. The EU welcomes announced delays in the entry into force of some of 
these QCOs. However, the EU would like to underline that some QCO notifications do not have a 
determined date of entry into force. For example, some  Orders have a precise date of entry into 
force of the Order, whereas some other Orders state that the Order shall come into force on the 
expiry of 180 days from the date of its publication in the Official Gazette. The EU requests India to 
provide structur ed information regarding the planned time for the adoption of these measures.  
2.256.   Furthermore, the EU noticed that there is an increasing number of TBT -notified Indian QCOs 
on chemicals and petrochemicals that are not implemented. The European Union wishes to seek 
reasons for repeated postponement of implementation of notified measures in this sector. Given the 
confusion this situation creates, the EU would like to call, once more, on India to provide an updated 
list of chemicals and petrochemicals, which have already been implemented and of those that are 
yet to be implemented, together with copies of relevant Quality Control Orders. The European Union 
would like to recall its request for clarifications explaining the reasons for establishing India -specific 
Quality Control Orders when these chemical and petrochemical products already comply with G/TBT/M/87  
 
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  internationally recognized standards. The EU would like to remind the authorities of India that in 
accordance with the TBT Agreement, standards are considered as volunta ry, whereas mandatory 
standards 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 creating unnecessary barriers to international 
trade. The EU would also like to encourage India to align the BIS standards with well -established 
and recognized international approaches.  
2.257.   The delegation of Singapore  provided the following  statement. Singapore echoes the 
concerns raised by Chinese Taipei, the United States and the European Union, and we would like to 
reiterate our concerns expressed at the previous meetings of this Committee. Singapore remains 
concerned that India's Quality  Control Orders for chemical and petrochemical substances could affect 
foreign chemical manufacturers' access to the Indian market, given the onerous requirements for 
industry stakeholders to comply with the new measures, some of which are not aligned with  
international standards. We understand that some industry players have put forth alternatives to 
meet the requirements of the Quality Control Orders, and we would like to respectfully request for 
India to positively consider these alternatives, to smoothe n the operational implementation of the 
Quality Control Orders, and to ensure that the mandatory requirements are not too onerous and 
challenging for the industry to comply with. We also respectfully urge India to align its Quality Control 
Orders with inte rnational standards to reduce the industry's compliance costs, and to ensure that 
the measures imposed are not more trade -restrictive than necessary.  
2.258.   In response, the delegation of India provided the following statement. As per the provisions 
of the QCO, t he products specified therein shall bear a Standard Mark under a valid licence from BIS 
as per Scheme -I of the BIS (Conformity Assessment) Regulations, 2018. Under this Scheme, factory 
inspection is a mandatory requirement for the grant of licence. Licence  to use the Standard Mark on 
a product is granted after assessing the manufacturing and testing capabilities through factory 
inspection of the manufacturing premises. During this visit, conformity of the product to the 
requirements of the relevant Indian S tandard is also established through in -house factory testing or 
testing at a third -party testing laboratory or a combination of both. At present, there is no provision 
in BIS (Conformity Assessment) Regulations, 2018, to undertake virtual inspection for co nformity 
assessment activities as an alternative. Foreign inspections were on hold due to the prevalent 
restrictions on international travel imposed. As the COVID -19 restrictions have eased out, BIS has 
started carrying out inspection where confirmation fo r travelling of fully vaccinated BIS officers has 
been received. BIS has nominated officers and applicants are asked to remit the inspection charges 
for carrying out inspection. On receipt of inspection charges, inspections are being planned. 
Preliminary i nspection for more than 100 applications has already been carried out. However, in 
some cases inspection are being delayed due to difficulty in issuance of VISA.  
2.259.   In accordance with the Code of Good Practice of WTO -TBT Agreement and as a policy, BIS 
tries t o align Indian Standards with International Standards of ISO and IEC, where available and to 
the extent possible, considering the specific climatic/environmental conditions and technological 
development in the country. Around 94% of Indian Standards, for w hich corresponding ISO and IEC 
standards are available, are harmonized with their ISO/IEC counterparts. In response to the 
statement of the US and Singapore, the details of QCOs and the relevant standards are available on 
the BIS website.58 As regards the point made by the EU about standards being voluntary, whereas 
mandatory standards being technical regulations, India requests the EU to refer to India's reply in 
its previous statements of TBT meetings.  
2.1.3.27   India - Order related to requirement of Non -GM cum GM  free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65159) 
2.260.   The delegation of the European Union  provided the following statement. The European Union 
would like to refer to its previous statements on this matter. The EU considers that the Order is 
disproportionate and that it creates unjustified barriers to trade, as the Indian requirement goes 
beyon d what is necessary to achieve the stated objective and puts an additional burden and costs 
on EU exporters. India should explain why it considers it necessary to impose such a burden on 
trading partners with a high prevalence of non -GM food on their domes tic market and a robust 
 
58 https://standardsbis.bsbedge.com/  and https://www.bis.gov.in/index.php/product -
certification/products -under -compulsory -certification/scheme -i-mark-scheme  / 
59 For previous statements follow the thread under ID 651 . G/TBT/M/87  
 
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  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, there 
are very strict traceability an d labelling requirements applicable to food that contains GMOs. These 
requirements allow for 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  that 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%.  
2.261.   The EU as well as India are both parties to the Carta gena Protocol on biosafety to the 
Convention on Biological Diversity. The EU adopted Regulation 1946/2006 on transboundary 
movements of genetically modified organisms. According to Article 12(2) of this Regulation, 
exporters of GMOs intended for direct use  as food or feed or for processing must accompany their 
exports with a document stating that the export contains or consists of GMOs. This obligation for 
accompanying documentation of GMOs provides the necessary reassurance to the importers and to 
the auth orities. Therefore, we consider that the additional certification of non -GM food is not needed 
and is unjustified.  
2.262.   The delegation of the United States  provided the following statement. The United States 
reiterates its 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. India has asserted 
that the measure is neither discri minatory nor trade restrictive because it is applied to imports from 
all countries, and because India and various trading partners are issuing their own certificates. The 
United States must stress that neither broad application nor various modes of complia nce offer 
justification for such a trade -restricting measure; rather, they highlight the parallel issues of uneven 
market access and inefficiency in biosafety regulation exacerbated by the measure. We once again 
urge India to rescind this measure and engag e with the United States and other trading partners to 
find a science -based, trade -facilitating alternative. The United States has previously proposed 
technical cooperation with the Food Safety and Standards Authority of India on numerous occasions; 
we onc e again extend this offer to work together to develop a mutually beneficial solution.  
2.263.   The delegation of Japan  provided the following statement. Japan would like to reiterate 
concerns raised at previous TBT Committee meetings, regarding India's measure whic h requires 24 
agricultural products imported to India to be accompanied by a certificate stating that they are not 
of genetically modified origin and do not contain genetic modification. Japan considers that this 
measure, having negative impact on agricult ural trade between India and other WTO Members, is 
more trade -restrictive than necessary. In Japan, under domestic laws, the import, distribution, 
cultivation, and other general uses of genetically modified agricultural products for human 
consumption are s ubject to safety evaluations, and agricultural products that are not approved by 
the evaluation process could not be imported nor distributed domestically. If certain items are 
already under appropriate control in the origin country, requiring those items to be accompanied by 
non-GM origin and GM free certificates is more trade -restrictive than necessary. Japan requests 
India to withdraw the requirement to attach certificates for foods that are properly controlled in the 
origin country.  
2.264.   The delegation of Australia  provided the following statement. Australia thanks India for its 
ongoing engagement and cooperation regarding the use of the non -GM origin and GM free certificate, 
as well as India's previous responses provided in the TBT Committee. Australia share s the view that 
GM use in agriculture needs to be safe, and we are strong supporters of robust, risk and science -
based regulation of GM. Further to Australia's previous statements on this issue, Australia reiterates 
that it is common international practice  to maintain regulatory oversight and controls on agricultural 
crops subject to genetic modification. As such, requiring GM assurances on a consignment -by-
consignment basis does not improve regulatory outcomes. In order to ensure that trade is not 
subject to unnecessary costs and additional regulatory burdens for both Australian exporters and 
Indian importers, Australia requests that alternate arrangements which recognize the regulatory 
systems in place by countries to control GM exports be implemented. Aus tralia maintains appropriate 
regulation of GM -crops and is able to provide assurances of which crops are and are not subject to 
GM. Australia appreciates India's cooperation in agreeing to a pathway forward during FSSAI's recent 
visit to Australia on this matter. The agreed pathway moves this matter towards more open trade, 
in accordance with the principles of the recently signed Australia -India Economic Cooperation and 
Trade Agreement (AI -ECTA). Australia looks forward to further collaborative engagement w ith India 
on this matter.  G/TBT/M/87  
 
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  2.265.   The delegation of Paraguay  provided the following statement. My delegation would like to 
thank the delegations of the United States and the European Union for placing this concern on today's 
agenda and reiterate its support for it . Several months ago now, we, together with other Members, 
asked India, through our representation in New Delhi, to reconsider this policy on the grounds that 
it is not consistent with its obligations to this Organization. We reiterate that we continue to await a 
response from India to our concerns and requests, and hope to have an update as soon as possible.  
2.266.   The delegation of Canada  provided the following statement. Canada would like to reiterate 
our concerns regarding the implementation of India's August 2020 Order, which mandates that a 
non-genetically modified or GM -free certificate accompany imported consignments of 24 imported 
food products. Canada remains concerned that India's Order will disproportionately impact the ability 
of GM -producing countries  to export to India and unnecessarily restrict international trade; we have 
raised these concerns during previous TBT Committee meetings as well as at the SPS Committee 
and in the Council for Trade in Goods. While Canada welcomes India's recent decision to  accept 
Canada's non -GM attestation on bean exports, this is only one of the 24 commodities impacted by 
the Order. We continue to have concerns with the potential trade impact on other crops covered by 
the Order. Canada continues to request that India to c onsider a less burdensome approach to 
meeting the Order's stated food safety goals. As previously stated, the robust, science -based 
regulatory frameworks developed in countries around the world, including in Canada, should be 
considered as they assess the risks of GM food products prior to their approval and 
commercialization. These products are authorized for commercialization only once they have 
received appropriate safety approvals.  
2.267.   Until a satisfactory solution is found and to minimize potential trade d isruptions, Canada 
again requests that India suspend the implementation of this measure and that trade be permitted 
to continue without a certificate requirement. This would allow for further engagement with Members 
to discuss and consider an alternate, le ss trade -restrictive measure to meet India's intended 
objective. Finally, given the Order's stated objective "to ensure the safety and wholesomeness of 
articles of food imported into India ", Canada once again reiterates its request that India notify the 
non-GM Order to the SPS Committee. We remain available and would welcome the opportunity to 
pursue further discussions on this issue in a bilateral setting.  
2.268.   The delegation of Uruguay  provided the following statement. Uruguay recognizes India's 
right to take measures to guarantee food safety 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 relat ion to the risk assessment 
methodology, 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. In the light of this objective, we wish to 
ask why the delegation of India still has not notified this measure to this Organiz ation's SPS 
Committee, as it has to the TBT Committee. Uruguay wishes to stress that it is important for 
Members to establish measures based on scientific principles and, in particular, to apply such 
measures with the objective of minimizing the negative t rade effects, in line with the provisions of 
the TBT and SPS agreements. Lastly, like Paraguay, we wish to reiterate that we continue to await 
a reply to the joint note submitted by a number of countries, including Uruguay, in New Delhi in 
January  2021, a year and a half ago.  
2.269.   The delegation of New Zealand  provided the following statement. New Zealand 
acknowledges and supports measures that focus on legitimate objectives, including the protection 
of human health and safety. 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 continues to encourage India to accept a country -wide 
assurance as an alternat ive to consignment -based non -GM certification.  
2.270.   The delegation of Argentina  provided the following statement. We would like to thank the 
EU and the US for including this specific trade concern on the Committee's agenda and request that 
Argentina's support f or it be put on record.  With regard to this measure, Argentina reiterates its 
concern and again stresses that the measure has no scientific explanation to support it. Argentina 
is concerned that this requirement would set a precedent for other products or even their derivatives 
to be included in the future, and that this requirement could be a barrier to trade. We therefore 
request India to consider reviewing this measure.  G/TBT/M/87  
 
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  2.271.   In response, the delegation of India provided the following statement. Th e requirement to 
regulate the import of GM food is not new. It already exists under the Environment Protection Act 
(1986). This requirement is already notified to WTO and is neither discriminatory nor trade restrictive 
as it is uniformly applicable to impo rts from all countries. The FSSAI order on 21 August 2020 made 
it mandatory for the 24 identified commodities to be accompanied with a Non -GMO origin cum GM -
free certificate issued by a competent national authority of the exporting country. On similar line s, 
India has issued such certificates for its exports to other countries. The Government of India has 
authorized Export Inspection Council (EIC) as the nodal agency for issuing Non -GMO certificates for 
export consignments. EIC is issuing more than 9,000 No n-GMO certificates for the export of primary 
food crops as well as processed food products for export to several countries. It may be noted that 
the said Order is not trade restrictive as the consignments of the identified commodities are already 
being acc epted for import to India along with the Non -GM origin cum GM -Free Certificate in the 
prescribed format. Section 7 of The Environment Protection Act (1986) and its Rules prescribes that 
no person shall import or export genetically engineered organisms/subs tances or cells except with 
the Genetic Engineering Approval Committee (GEAC). DGFT Notification No.2 (RE -2006)/2004 -2009 
dated 7 April 2006 on "Import of Genetically Modified Food" states that import of GMOs/LMOs for 
Food will be governed by the provision s of the Environment Protection Act, 1986 and Rules 1989. 
GEAC has so far not approved any of the crop varieties of Genetically Modified/Engineered origin 
listed on the Order mentioned above. The requirement of a Non -GM certificate for import of 24 food 
crops is an assurance required from Competent Authorities of exporting countries that the food crops 
exported to India are of Non -GM origin and GM -free. As of date, several trade partners like the USA, 
UK, Australia, Canada, Türkiye, Iran, China, EU, includi ng Italy, Germany, France and Thailand, are 
already providing requisite certificates.  
2.1.3.28   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1166  (ID 
66660) 
2.272.   The delegation of China  provid ed the following statement. We support Saudi Arabia's 
restrictions on hazardous substances in electrical and electronic products, however, after careful 
study, the draft regulations proposed by Saudi Arabia are inconsistent with international practice. 
especially the provisions on conformity assessment procedures create unnecessary obstacles, China 
would like to raise concerns as follows. 1. According to Article 5 and Appendix 3 , suppliers need to 
obtain a conformity certificate (Type 1a) from an approved c ertification organization. However, 
according to the practice of global implementation of RoHS, it is usually the manufacturer to prepare 
technical documents for products to prove their conformity in the light of international standard IEC 
63000 and to pro vide a conformity declaration. In response to the testing report requirements 
described in the notified regulations, a full product testing report means that companies need to test 
every single component, at the homogenous material level, which is extremel y 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 res trictions on hazardous substances implemented and 
accepted by the international community. Therefore, it is recommended that the conformity 
assessment procedures would comply with current global practices, and the preparation of technical 
documents would c omply with IEC 63000.  
2.273.   2. The applicable scope of the regulations of this notification is electrical and electronic 
equipment, but the batteries and accumulators (HS code 8506 and 8507) are included in Appendix. 
Based on the differences between batteries an d electrical and electronic equipment, and with 
reference to the current management and control across the world, it is recommended that this 
regulation excludes batteries and accumulators from the scope of this regulation. 3. Regarding the 
allowable perce ntage of hazardous substances in electrical and electronic equipment or devices 
specified in the Appendix, the percentage of many materials (copper alloys, steel alloys, and high -
temperature solders, etc.) is currently unable to meet the limitation set in regulations 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 Ministry of Industry and Information Technology 
of China to clarify the corresponding exemptions.  
 
60 For previous statements follow the thread under ID 666 . G/TBT/M/87  
 
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  2.274.   The delegation of the United States  provided the following statement. The United States 
thanks Saudi Arabia for its continued engagement on the "Techn ical Regulation for the Restrictions 
of Hazardous Substances (RoHS). " We were pleased to receive the June response from Saudi 
Arabia's Standards Organization (SASO) regarding our concerns to the Kingdom's RoHS regulation. 
In its response SASO expressed its  intent to accept a Supplier's Declaration of Conformity (SDoC) 
as it begins to implement the RoHS regulation. As we understand it now, the decision to accept 
SDoCs under the RoHS regulation aligns the Kingdom's conformity assessment requirements under 
the regulation with those of other WTO Members and should resolve a potentially significant trade 
barrier. We thank the Kingdom for its fulsome engagement - with governments and with private 
sector stakeholders - and for taking our comments into account. We a lso note and appreciate the 
decision to provide a staged implementation of the regulation, based on product category, which 
began earlier this month. Given the broad scope of the measure, and a significant change in 
conformity assessment requirements as th e measure is taking effect, we look forward to seeing the 
revised regulation and guidance as soon as possible. We may have additional questions and 
comments for SASO as those revised regulations are published and the requirements are 
implemented. We thank SASO, in advance, for its continued engagement, and we appreciate SASO's 
willingness to take our comments into account.  
2.275.   The delegation of the United Kingdom  provided the following statement. The United Kingdom 
thanks Saudi Arabia for the constructive engag ement on notification G/TBT/N/SAU/1166 , which sets 
out its technical requirements for the restriction of hazardous substances in electrical and electronic 
equipment. We would like to thank the Saudi Standards, Metrology, and Quality Organization (SASO) 
for holding the workshop wi th stakeholders in May and for providing a written response to our 
subsequent questions. The United Kingdom notes that, according to this written response, Saudi 
Arabian authorities will now accept a Supplier's Declaration of Conformity. The United Kingdom  
welcomes this change. If implemented as described, acceptance of Supplier's Declaration of 
Conformity will be consistent with common international practice. It will also provide businesses with 
a less burdensome means of demonstrating compliance with the technical regulation than third -
party conformity certification. Where several regulations that require a Declaration of Conformity 
apply to a product, it is common international practice that the manufacturer is allowed to merge all 
these declarations into  one document. We would be grateful if Saudi Arabia could confirm that Saudi 
Arabian authorities will accept a single Declaration of Conformity to cover all relevant legislation.  
2.276.   The United Kingdom appreciates that SASO stated in their written response tha t they will 
amend the implementation guidelines to reflect the acceptance of a Supplier's Declaration of 
Conformity. We would encourage Saudi Arabia to also amend the technical regulation itself to reflect 
this change, and notify the updated text of the te chnical regulation and the amended guidelines to 
the TBT Committee in an addendum notification. We would like to reiterate our thanks to Saudi 
Arabia for delaying the implementation date and for developing guidelines to support industry in 
complying with t he measure. We will contact you if we have any further questions. The United 
Kingdom thanks Saudi Arabia for their continued productive engagement, and we look forward to 
future correspondence with Saudi Arabia on this matter.  
2.277.   The delegation of the Europea n Union  provided the following statement. The European Union 
thanks Saudi Arabia for its availability to discuss this issue bilaterally. The EU appreciated the 
postponement of the application of the Technical Regulation for Restriction of Hazardous Substan ces 
(Saudi RoHS) by six months (until 5 July 2022) and the phased implementation dates for product 
categories notified to the TBT Committee on 10 February 2022 (G/TBT/N/SAU/1166/Add.1 ). The 
practical implementation of the Saudi RoHS Regulation will be followed with in terest. The EU 
welcomes the Guidance document to industry on the Saudi RoHS and would appreciate information 
on any further plans to involve trade partners and stakeholders in the practical implementation of 
the Regulation, as well as eventual measures to monitor its compliance. As regards conformity 
assessment, the EU welcomes the confirmation, in the bilateral meeting, that Saudi Arabia has 
decided to accept Supplier's Declaration of Conformity by the manufacturer or its authorized 
representative for prod ucts included under the scope of the Saudi RoHS, as it is done in common 
international and EU practice. The EU stresses that this is an important development and invites 
Saudi Arabia to notify the relevant measure to the TBT Committee and to update the Gui dance 
document to industry accordingly.  
2.278.   The EU understands that Saudi Arabia will introduce expiry dates for the items included in 
the list of substances excluded from the application of hazardous material limits (Annex 1a to the 
Technical Regulation). Sau di Arabia will introduce, in addition, mechanisms to amend the list of G/TBT/M/87  
 
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  substances excluded from the application of hazardous material limits, as well as the list of restricted 
substances (Annex 1b to the Technical Regulation), for their alignment to the EU  RoHS. The EU 
welcomes those developments. The EU highlights the importance of promoting GCC harmonized 
requirements and their uniform application and the mutual recognition of conformity assessment 
results in the region, instead of the proliferation of se parated national RoHS regulations. In this 
context, we would like to enquire about the timeframe for adoption of the draft GCC Technical 
Regulations for the Restriction of the use of certain Hazardous Substances in electrical and electronic 
equipment, noti fied to the TBT Committee in March 2018 ( G/TBT/N/SAU/1048 ). The EU understands 
that, once adopted, the GCC RoHS Technical Regulations will replace national RoHS provisions in the 
region. The European Union welcomes any workshop or information session with stakeholders and 
remains  available to further discuss technical issues bilaterally.  
2.279.   The delegation 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. We 
reiterate our concerns from previous meetings of the WTO TBT Committee and remain concerned 
that these requirements may have a negative impact on trade for a wide r ange of products. 
Switzerland appreciates the Kingdom of Saudi Arabia's recent efforts to allow for a smooth 
implementation of the measures, such as the postponement of the application of the measures, the 
phased implementation, the issuance of a guidance document or the useful engagement with 
interested Members and stakeholders. We also understand the Kingdom of Saudi Arabia's legitimate 
objective to protect the environment and public health and safety. Switzerland encourages the 
Kingdom of Saudi Arabia to  ensure that these requirements do not create unnecessary obstacles to 
trade. We would in particular welcome any clarifications as to the acceptance of supplier's declaration 
of conformity which is common international practice. Furthermore, the implementa tion of the 
requirements still lead to uncertainties for manufacturers and conformity assessment bodies, such 
as regarding the scope or the process for testing the products or critical components. Finally, we 
encourage the Kingdom of Saudi Arabia to contin ue engaging with interested stakeholders and 
providing clear and transparent guidelines in order to support the implementation of these 
requirements.  
2.280.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement. 
Saudi Arabia would like to express appreciation for the concerns addressed by China, the United 
States, the United Kingdom, the European Union and Switzerland for their valuable comments on 
the Technical Regulation for Restriction of Hazardous Substances. The Saudi Tec hnical Regulations 
are developed in line with international practices and TBT good regulatory practices (GRP). As far as 
conformity assessment procedures for products included in the scope of the RoHS Technical 
Regulation, we would like to inform you that a supplier declaration "Self -Declaration" of conformity 
for products supplied either by the manufacturer or the legal representative of the manufacturer will 
be accepted, and the competent authority in Saudi Arabia is in the process of publishing this deci sion. 
Finally, Saudi Arabia is always pleased to engage in bilateral discussions through conducting 
workshops and meetings to clarify the regulations and receive feedback and enquiries, which will be 
revised and considered.  
2.1.3.29   India – Draft Food Safety and St andards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 66761) 
2.281.   The delegation of Mexico  provided the following statement. The delegation of Mexico refers 
to its statement at the previous meeting of this Committee in March 2022 on the draft Food Safety 
and Standards (Import) Amendment Regulation, notified by the Government of India to the Mem bers 
of this Committee on 25 November 2020 in document G/TBT/N/IND/180 . During the meeting in 
March, the delegation of India indicated that it would publish the detailed guides for the registration 
of companies, and will allow enough time for compliance with the measure. However, a s things 
stand, we do not have any more information on the development of the measure or the setting of a 
date of entry into force. We would therefore be grateful if any updated information in this regard 
could be shared with us. We also reiterate the grea t importance of this measure for Mexico's industry 
and Government, as well as our interest in being able to follow it up in a timely manner. The 
delegation of Mexico thanks the delegation of India for giving its consideration to this statement.  
 
61 For previous statements follow the thread under ID 667 . G/TBT/M/87  
 
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  2.282.   The delegat ion of the European Union  provided the following statement. The European Union 
would like to refer to its previous statements on this matter. At the outset, the European Union 
recalls that it sent written comments and is still waiting for a written reply. We again ask that India 
please provide a written reply. We understand that on 10 November 2021 FSSAI has adopted and 
published a revised and final version of the measure, which is applicable as of June 2022. The 
measure appears much more trade restrictive than necessary to fulfil the intended food safety 
objectives. Furthermore, many questions put forward by foreign food (and drink) manufacturers and 
competent authorities remain unanswered, and this tends to create an unpredictable trading 
environment. The European Union would like to reiterate already raised concerns. The scope of the 
application of the measure remains unclear: the revised and now final and adopted measure provides 
for a registration obligation. Even though it is provided that this obligati on shall apply to food (and 
drink) products presenting a specific risk, no list of such products exists in the rules themselves. The 
inclusion on the list of low -risk products, in particular wines and spirits since they have inherently 
stable nature, would  be disproportionate. Therefore, the European Union would appreciate if India 
could clarify whether products which are inherently stable and do not present sanitary risks such as 
spirits or wine, are excluded from the scope of these new obligations. The me asure provides for 
registration and inspection of foreign food (and drink) manufacturing facilities. However, further 
clarity is needed with regard to the definition of "facilities " and the modalities related to inspections 
(and audits) of these facilities . Last but not least, the transition period initially foreseen is not 
sufficient and should be extended to 24 months.  
2.283.   The delegation of the United States  provided the following statement. The United States 
remains concerned with India's draft measure, noti fied to the WTO TBT Committee as 
G/TBT/N/IND/180 . As the Unit ed States has noted in previous TBT Committee meetings, this draft 
regulation leaves many unanswered questions for foreign food manufacturing facilities, competent 
authorities, and other stakeholders. The draft regulation states that India may identify cat egories 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 pro posed technical regulation and the scientific 
and technical information India will use to determine the specific "risk" for food product categories. 
We again ask that India please provide further information on this measure and its plan for 
implementation.  
2.284.   The delegation of Japan  provided the following statement. Japan shares the concerns with 
other Members on India's introduced amendment regulation on food safety and standards. The 
regulation would impose additional burdens on business operators who plan t o export food products 
to India. However, there are many unclear points yet to be explained by India including definitions 
of "food manufacturing facility ", scope of "food" subject to the regulation, and the registration 
procedure for facilities inspection  and audit. Japan requests India to submit TBT and SPS notifications 
and provide WTO Members with the opportunity to comment on the detailed regulation regarding 
the scope of food, facilities registration procedure, and so forth. Japan urges India to since rely 
address Member countries' concerns and comments to ensure the new rule does not create 
unnecessary trade barriers.  
2.285.   The delegation of Australia  provided the following statement. Australia recognizes the right 
of the Indian Government to take measures n ecessary to protect public health. Australia thanks 
India for their engagement on this issue between the Food Safety and Standards Authority of India 
(FSSAI) and the Department of Agriculture, Fisheries and Forestry (DAFF), including with FSSAI 
officials o n their recent visit to Australia. FSSAI has previously advised that the proposed regulations 
will not apply to all food establishments. FSSAI also advised that requirements will only apply to 
manufacturers of specific commodities based on a history of non -compliance detected at the border. 
Australia would welcome written confirmation of this advice from FSSAI. Australia respectfully 
recommends the regulation be amended to clarify the categories of food included. The proposed 
measures should be linked to th e risks posed by the imported food and aligned with Codex 
international food standards, guidelines and codes of practices. Australia believes that food 
standards should be grounded in sound scientific and risk -based principles. Australia is happy to 
work w ith India to support a more risk -based approach to food safety and looks forward to further 
engagement on this proposed regulation.  
2.286.   The delegation of Canada  provided the following statement. Canada would like to reiterate 
concerns raised at previous TBT Co mmittee meetings regarding India's draft amendment to its Food 
Safety Standards (Import) Amendment Regulation pertaining to the registration, inspection and/or G/TBT/M/87  
 
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  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 elements contained in India's proposed amendments remain ambiguous. As previously 
stated, it is unclear what criteria would be used to determine th e 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 
resulting from the pandemic. In  addition, Canada remains concerned with the measure's target 
commodities, source -countries, implementation plan, audit rates, compliance actions and appeals. 
We are of the view that India's approach in these areas could create unnecessary obstacles to tra de. 
Canada notes that India has yet to respond to comments submitted to India's Enquiry Point on 21 
January 2021. We would appreciate if India could provide an update as to when it expects to provide 
the requested details. In closing, Canada recalls its re quest to India to notify these amendments to 
the SPS Committee given that India's proposed regulation covers food safety measures aimed at 
protecting human health and safety.  
2.287.   The delegation of New Zealand  provided the following statement. New Zealand 
ackno wledges and supports measures that focus on legitimate objectives, including the protection 
of human health and safety. However, New Zealand would like to understand more about the 
intentions of the proposed requirements in relation to the proposed require ments in relation to the 
registration and auditing of foreign food manufacturing premises, particularly around why this is a 
requirement for foreign manufacturers only. New Zealand would appreciate clarification on the full 
scope of products to which this measure applies. We also request further detail regarding how the 
measure will be implemented, including what timeframe will be established to ensure exporters have 
adequate notice to comply. We note that, without further detail, these requirements generat e 
uncertainty for manufacturers and exporters.  
2.288.   The delegation of Argentina  provided the following statement. We would like to thank Mexico, 
the EU and the US for including this specific trade concern on the Committee's agenda and request 
that Argentina's s upport be put on record.  We would like to point out that Argentina has submitted 
timely written queries to the Indian  Focal Point and is still awaiting a response. It is worth mentioning 
that the publication of the draft regulation has prompted Argentine s takeholders to engage in 
continuous consultations as to its scope, without there being any official response so far, which 
creates uncertainty for our exporters.  Argentina's Agro -Industrial Attaché Office in India held a 
meeting with the Director of the FS SAI in New Delhi in March this year and we discussed this 
regulation. The response that we received was that the implementation of the regulation was still 
under review, as comments had been received from all stakeholders. The FSSAI also made it clear 
to Argentine officials in Delhi that the implementation of the measure would be communicated well 
in advance. However, this was a bilateral conversation. There was no written communication of any 
kind regarding all the queries that Argentina formally submitted  in writing.  We therefore urge India 
to submit responses to our queries and to provide notice of the measure in time for comment.  
2.289.   In response, the delegation of India provided the following statement. Based on the intension 
to determine the compliance stat us of foreign food manufacturing facilities with the FSSR 
requirements and food standards, the FSSAI came up with the regulations named FSS (Imports) 
First Amendment Regulations, 2021, regarding registration and inspection of Foreign Food 
manufacturing fac ilities intended for export to India. As prescribed under the said regulations, Food 
Authority may, based on the risk associated, specify the categories of food products and accordingly, 
Foreign Food manufacturing facilities falling under such categories a nd desirous to export such article 
of food to India shall register with the Food Authority before exporting to India. However, the detailed 
guidelines/SOP including the scope of this regulations is under consideration. Therefore, in 
pursuance of the said r egulations, FSSAI is in process of making such guidelines that would include 
procedural information and guidance for the foreign food manufacturers to comply with the said 
regulations. Moreover, once the SOP will be finalized the same will be separately pu blished, and 
sufficient time considering the request for implementation shall be provided for the compliance 
purpose.  G/TBT/M/87  
 
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  2.1.3.30   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 13362) 
2.290.   The delegation of Indonesia  provided the following statement. The Indonesian Gove rnment 
is extending our gratitude to India for responding to the concerns conveyed by Indonesia regarding 
the policy of import restrictions on tyre products at the TBT Committee meeting in March 2022. 
However, Indonesia regrets that until now it has not fo und an adequate solution to overcome these 
problems. Indonesia is fully aware that India has imposed import restrictions on tyre products with 
certain types and size categories that can be produced by tyre manufacturers in India. This policy 
was implemente d shortly after India imposed a temporary import ban on tyre products to India for 
a period of 6 months as stated in notification no. 12/2015 -2020 dated 12  June 2020, regarding 
Changes in Tyre Import Policy. The implementation of this policy has the potent ial to hamper tyre 
exports to India considering that the choice of tyre products that can be exported is very limited and 
even has the potential to eliminate market access for imported tyre products given the various types 
and sizes of tyres produced by In dia as one of the world's main producers.  
2.291.   Although there are no official provisions governing the restrictions on the import of these 
tyres, importers are required to make a separate statement by electronic mail regarding import 
restrictions for certain ty pes and categories of tyre sizes that can be produced domestically, where 
violations of this will be imposed criminal sanctions based on the FTDR Act 1992. In addition, 
Indonesia sees discriminatory treatment in the application of the said policy, where th e policy is 
applied selectively by targeting certain Member countries that have the potential to become 
competitors and interfere with market access for domestic tyre products and have de facto hampered 
product exports Indonesian tyres. In addition to this , we also intend to ask for further clarification 
regarding the application of a royalty policy or marking fee on tyre products that use the IS Mark. 
Indonesia is of the view that the imposition of the IS Mark marking fee on tyre products to be 
exported to  third countries has the potential to burden businesses and create unnecessary trade 
barriers to international trade. The imposition of such marking fees does not have a valid justification 
and has no relation to the protection of human health, safety or p revention of fraudulent practices. 
Indonesia perceives that the implementation of these two policies is not in line with the principle of 
non-discrimination and has the potential to create unnecessary barriers to international trade as 
stipulated in Articl e 2.1 and Article 2.2 of the TBT Agreement. In this regard, Indonesia hopes that 
India can provide further clarification on these two issues and asks India to review or cancel the 
policy to ensure its conformity with the applicable provisions of the WTO TB T Agreement.  
2.292.   In response, the delegation of India provided the following statement. The comments related 
to the import licensing measures have been already addressed in the Committee on Import 
Licensing, Committee on Market Access and also in the Council f or Trade in Goods. The conformity 
assessment activities of BIS with respect to product certification are as per Scheme -I of the BIS 
(Conformity Assessment) Regulations, 2018. As informed earlier on the same concern, the marking 
fee is uniformly applicable to all manufacturers, domestic or foreign as per the provisions of this 
scheme. The marking fee is charged for covering the cost applicable to BIS in carrying out the 
conformity assessment -related works, which includes administrative overheads, cost of sur veillance 
including purchase of market samples and testing charges of the samples drawn from 
factory/market.  
2.1.3.31   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022 , G/TBT/N/CHN/1023 , 
G/TBT/N/CHN/1024 , G/TBT/N/CHN/1025 , G/TBT/N/CHN/1026 , G/TBT/N/CHN/1029 , 
G/TBT/N/CHN/1313  (ID 42863) 
2.293.   The delegation of the Republic of Korea  provided the following statement.  The Republic of 
Korea recognizes China's efforts to protect the health of its people by enhancing the efficiency of 
supervision and management of medical devices life cycle, and strengthening corporate 
responsibilit y through the Regulations for the Supervision and Administration of Medical Devices. 
Companies exporting medical devices to China are required to submit a test report issued by a 
"qualified testing laboratory " in order to undergo marketing authorization un der the aforementioned 
Regulations. However, it remains unclear what the specific definition or scope of "qualified testing 
laboratories " means under the Medical Devices Regulations. This is the same issue Korea raised at 
 
62 For previous statements follow the thread under ID 133 . 
63 For previous state ments follow the thread under ID 428 . G/TBT/M/87  
 
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  the previous TBT Committee meeting s, and in its 2022 March TBT meeting response, China provided 
an explanation of a rticle 75 of the Regulations. As regards to China's response, we request further 
explanation of what "inspection institutions recognized by the certification, accreditation an d drug 
authorities " mean. Korea recommends China to include "internationally accredited testing 
laboratories " that are equipped with the appropriate facilities and manpower in accordance with 
relevant international standards and regulations as "qualified t esting laboratories. " We view that our 
request is in line with China's intention to promote innovation in its domestic medical device industry 
by simplifying China's pre -market review process to enable novel high -quality medical devices to 
enter its market  in a timely manner. Therefore, we request that "internationally accredited testing 
laboratories " be included in China's definition of "qualified testing laboratories. " 
2.294.   In response, the delegation of China  provided the following statement. China regrets th at 
Korea did not make its statements on this topic available in parallel with the meeting and here I 
would like to make a brief response.  The newly revised Regulations on the Supervision and 
Administration of Medical Devices came into effect on 1  June 202 1. According to article 75 of the 
Regulations, only the inspection institutions recognized by the certification, accreditation, and drug 
authorities can carry out the inspection of medical devices. Therefore, if Korea wishes to carry out 
medical device tes ting, overseas laboratories can contact the above -mentioned competent 
authorities.  
2.1.3.32   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 , G/TBT/N/IND/32/Add .3 (ID 22464) 
2.295.   The delegation of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu appreciates India for explaining its on -site inspection measures at the previous meeting in 
March 2022. However, we remain concerned about the application procedures of IS 17404:2020 
(electrogalvanized hot rolled and cold reduced carbon steel sheets and strips) certification under the 
Steel and Steel Products ( Quality Control) Order, 2020. Firstly, India is our fourth largest exporting 
market of the products concerned. The annual export trade volume amounted to more than 3 million 
US dollars in 2020 and 2021. Since IS 17404:2020 came into force, our companies ha ve faced 
difficulties in receiving on ‐site inspection by BIS officials due to ongoing impact of COVID -19 and its 
associated quarantine policies. The export value sharply declined to USD 215,000 dollars in the first 
half of this year. It seriously hampered India from importing high quality steel and steel products 
from our companies and impaired bilateral trade. We strongly suggest that India implement 
alternative measures during the pandemic, such as accepting test reports and inspection reports 
from other WTO Members or accept remote factory inspection. Secondly, on -site factory 
visit/inspection is a costly requirement, which may cause unnecessary trade burden to 
manufacturers outside of India. We would like to draw India's attention to the trend of the ado ption 
of digital technologies to accelerate the certification process and suggest that India accept 
remote/virtual inspection as one of the conformity assessment measures.  
2.296.   The delegation of the European Union  provided the following statement. The EU would like 
to support the delegation of Chinese Taipei. India continues to define and introduce specific 
standards and certification requirements for a number of products – under the umbrella of the 
Quality Control Orders (QCOs). The QCOs require physical audit at manufacturers' premises by an 
auditor of the Bureau of Indian Standards (BIS) in order for products manufactured in third countries 
to receive the approval for exports to India. The EU deeply regrets that India repeatedly refused to 
consider meaningful alternative options to foreign audits – which were suspended for over two years 
due to the SARS COV -2 pandemic - such as virtual audits or audits conducted by internationally 
recognized third agencies/entities. The EU welcomes the fact that applications fo r inspections are 
processed gradually. However, the EU would like to stress the benefits that virtual audits and 
recognition of laboratories outside India would have for India and its partners. The EU would 
therefore like to take this opportunity to reques t Indian authorities to consider preparing rules for 
international recognition of laboratories by the BIS, as foreseen by legislation in place. This would 
speed -up audits, and lower the cost of mandatory testing for foreign manufacturers.  
2.297.   The EU would like  to reiterate its stance that the QCOs in question have a protectionist 
orientation. The increasing number of QCOs across sectors is sending worrying signals to EU 
industry, EU investors, and EU member States. Once these QCOs come into force, they will cau se 
 
64 For previous statements follow the thread under ID 224 . G/TBT/M/87  
 
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  extra burden and economic cost to the EU industry that will have to undergo cumbersome procedures 
to obtain necessary permissions and/or licences for products already certified under established 
international standards. Furthermore, the foreign manufact urers have to make necessary 
modifications in their tooling systems for the ISI mark, which could cause temporary shutdown of 
some production lines. In this context, the QCOs add little value for Indian consumers, making the 
reason of their introduction no t evident. The Steel and Steel Products (Quality Control) Order, 2020 
targets 145 steel or steel products and seven goods and articles. Majority of the steel products are 
already under the QCOs. However, given the regular extensions for some steel and stee l products, 
it remains unclear to the EU, on the exact number of steel products, which are already under the 
mandatory certification and those, which are still outside the purview of the QCO. The EU would 
appreciate, if India could provide an updated list of steel and steel products for which the QCOs are 
in force, together with the list of steel products for which the implementation of QCOs has been 
deferred. The EU would also like to know whether India plans to further expand the scope of the 
Steel and St eel Products (Quality Control) Order of December 2020. Finally, does India plan to accept 
steel and steel products of foreign manufacturers produced in line with international standards, such 
as ISO, and prune the list of steel and steel products falling u nder the QCOs?  
2.298.   In response, the delegation of India provided the following statement. The products under 
mandatory certification are notified by the concerned Line Ministries (Regulator) of the Government 
of India through the issuance of Quality Control Or ders (QCOs). Gradually all Indian Standard on 
steel will be covered under the QCO in a phased manner. As per the provisions of the QCO, the 
products specified therein shall bear a Standard Mark under a valid licence from BIS as per Scheme -
I of the BIS (Con formity Assessment) Regulations, 2018. Under this Scheme, factory inspection is a 
mandatory requirement for the purpose of grant of licence. Licence to use the Standard Mark on a 
product is granted after assessing the manufacturing and testing capabilities  through factory 
inspection of the manufacturing premises. During this visit, conformity of the product to the 
requirements of the relevant Indian Standard is also established through in -house factory testing or 
testing at a third -party testing laboratory or a combination of both. At present, there is no provision 
in BIS (Conformity Assessment) Regulations, 2018, to undertake virtual inspection for conformity 
assessment activities as an alternative.  
2.299.   Mandatory BIS certification for steel products is enforced through notification of QCOs to 
ensure that the quality of steel being manufactured by domestic producers or imported in the country 
is as per the Indian standards. The implementation of QCOs ensur es the availability of quality steel 
and steel products to the end -users. It saves the Indian consumers from dumping of spurious and 
defective steel and steel products. Members are aware that the WTO recognizes the Member's right 
to implement measures to a chieve legitimate policy objectives, such as protecting human health and 
safety, protecting the environment, preventing unfair trade practices, or national security. The 
technical regulations / QCOs on steel and steel products have been issued based on suc h policy 
objectives. Hence QCOs notified by the government are not trade restrictive but necessary to fulfill 
a legitimate objective. As far as possible date of enforcement of QCOs is not extended from the first 
date of enforcement. However, due to excepti onal cases, if there are any specific requests for 
extension, they are examined on merit.  
2.300.   Foreign inspections were on hold due to the prevalent restrictions on international travel 
imposed. As the COVID -19 restrictions have eased out, BIS has started carry ing out inspection where 
confirmation for travelling of fully vaccinated BIS officers has been received. BIS has nominated 
officers and applicants are asked to remit the inspection charges for carrying out inspection. On 
receipt of inspection charges, insp ections are being planned. Preliminary inspection for more than 
100 applications have already been carried out. However, in some cases inspections are being 
delayed due to difficulty in issuance of visa.  
2.1.3.33   China - Encryption Law of the People's Republic of C hina by the Office of State 
Commercial Cryptography Administration (OSCCA) (ID 53465) 
2.301.   The delegation of Japan  provided the following statement. Japan continues to have concerns 
regarding China's Encryption Law that entered into force on 1 January 2020 and would like to refer 
to the previous statement we made at the last TBT Committee in March 2022. Japan would like to 
 
65 For previous statements follow the thread under ID 534 . G/TBT/M/87  
 
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  request that China's regulation not hamper the activities of foreign companies or market access to 
China.  
2.302.   The delegation of the European Unio n 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 of 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 have already negatively impacted business confidence. The EU also notes, with 
concern, that the new law does not recognize China's previous commitm ent 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 Administration (SCA). 
The EU calls on China to en sure 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 possibil ity 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, including 
participation by chipmakers in standardization bodies , including working group 3 of the TC260 and 
the SCA's own Cryptography Industry Standardisation Technical Committee (CISTC). The EU 
requests that applications to these bodies be replied to in a timely manner.  
2.303.   The delegation of the United States  provided t he following statement. The United States 
refers to its statement on the Cybersecurity Law and supports other Members' interventions.  
2.304.   The delegation of Canada  provided the following statement. Canada reiterates the following 
points from previous meetings o f the Committee: China's response to Canada's written comments 
on China's State draft of Cryptography Administration's cryptography regulations, which Canada 
provided in September 2020; further clarity, transparency and predictability in China's regulation s 
and laws related to Encryption and Cryptography, including the definition of terms; clarification that 
international standards will be used; and further precision on the measures' scope; and China's 
notification of the draft regulations to this Committee . 
2.305.   In response, the delegation of China  provided the following statement. The Law on 
Cryptography was enforced on 1 January 2020. It clearly stipulates that government agencies shall 
follow the principle of non -discrimination, and treat all organizations eq ually, including foreign -
invested enterprises that engage in commercial cryptography research, production, sales, service, 
import, and export, etc. China encourages commercial cryptography technical cooperation based on 
voluntary principles 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 administration.  
2.1.3.34   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629 , G/TBT/N/EU/826  (ID 53966) 
2.306.   The delegation of Brazil provided the following statement. In August 2021, the European 
Union notified a draft regulation proposing changes to Part 3 of Annex VI of the Regulation (EC) No 
1272/2008 of the European Parliament and of the Council on Classification, Labelling an d Packaging 
of Substances and Mixtures (CLP), which introduce a stricter classification of reproductive toxicity to 
2-ethylhexanoic acid (2 -EHA) from Repr. 2 to Repr. 1B. The revaluation process was initiated in 
2014, when ECHA requested new studies to be carried out, specifically an Extended One -Generation 
Reproductive Toxicity Study (EOGRTS). A Substance evaluation (SeV) process was then carried on 
by Spain, which recommended maintaining the previous classification of reproductive toxicity 
(Repr.2, H361d) . At the time, the only modification suggested was the introduction of an explanatory 
note, which clarified the fundamentals of the classification in question. The competent authorities 
then opened a public consultation for the submission of comments on th e dossier resulting from the 
SeV and additional information by authorities of other member States and members of the private 
sector. During this period, Germany and France submitted a reclassification proposal to Repr. 1B, 
based on analysis of analogy (als o called "read-across ") with the substance valproic acid.  
2.307.   The use of read -across relies on the assumption that, due to the presence of similar chemical 
aspects, the substances in question will have similar effects when exposed to the same tests, and 
 
66 For previous statements follow the thread under ID 539 . G/TBT/M/87  
 
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  thus, will reveal the same toxicity. According to our private sector, this does not seem to be the 
case. The reproductive toxicity studies specific to 2 -EHA, which contradict the applicability of read -
across with valproic acid, make up the best technical informa tion to support the classification of 
reproductive toxicity, as they are a direct analysis of the substance, without relying on assumptions 
of similarity. Studies specific to 2 -EHA conclude that the most appropriate classification would be 
the Repr. 2. The  EU has claimed that its analysis has considered studies specific to 2 -EHA and not 
only read -across ones. Brazil is still concerned, though, that the more restrictive classification 
adopted by the EU is not justified. Brazil would also like to note that, a ccording to the EU, the 
reclassification of the product as 1B would not entail higher costs associated with the registration 
process of chemicals. Nevertheless, the reclassification will still have a negative impact on the 
preferences of importers of the s ubstance, who will have the wrong indication of its actual level of 
risk. We believe, therefore, that these regulatory changes would be more trade -restrictive than 
necessary to fulfill the EU legitimate objectives of health protection. Brazil thanks the EU  for its 
statement in our last meeting, clarifying procedural aspects of its legislation and informing that if 
there would be no objection for the European Parliament and the Council, the measure should be 
published in the second half of April. In this sen se, we would like to ask if the EU could provide an 
update on the status of the proposal, regarding the current and next steps of the process towards 
adoption and entry into force.  
2.308.   The delegation of the Russian Federation  provided the following statement. Russian 
Federation reiterates statements made during the previous meetings of the TBT Committee and CTG 
with regard to the cobalt classification as a carcinogen 1b for all routes of exposure. We stress that 
this measure was adopted in the absence of suffic ient scientific justification, neither laboratory nor 
epidemiological, without taking into account grounded comments and opinions of the WTO Members 
and business community. At the same time, we  appreciate efforts of the EU on adoption of the 
gastric bioelu tion protocol at the EU and the OECD  levels. However, the EU has not adopted this 
methodology and has not incorporated its use into the CLP Regulation as a regular practice of 
classifying alloys and compounds that will allow to exclude many cobalt -containi ng products from 
the scope of further restrictions which will be developed within the framework of the implementation 
of this classification decision. We urge the European Union to adopt this methodology as soon as 
possible.  
2.309.   In response, the delegation of the European Union  provided the following statement. The 
European Union would like to thank Brazil for the continued interest in this issue and for the written 
comments concerning the classification of the 2 -ethylhexanoic acid (2 -EHA) in the 18th adaption to 
technical and scientific progress (ATP) of the Classification, Labelling and Packaging (CLP) 
Regulation.67 The EU notes that the written reply to the comments of Brazil was sent on 25  November 
2021 and the oral reply was provided in the March TBT Commit tee. Therefore, the EU would like to 
refer to the written reply and the minutes of the March TBT Committee for details. As to the status 
of the proposal, the EU would like to recall that the draft 18th adaption to technical and scientific 
progress (ATP) of  the Classification, Labelling and Packaging (CLP) Regulation was presented for a 
final consultation at the meeting of the Competent Authorities on REACH and the CLP expert group 
(CARACAL) on 19 October 2021. Based on that consultation, as well as on all p reviously received 
comments, including comments from WTO Members, the EU concluded that the proposed 
classification of the substance 2 - ethylhexanoic acid (2 -EHA) is appropriate and the 18th ATP was 
adopted by the Commission on 16 February 2022. Following the two months scrutiny period for the 
European Parliament and the Council, during which no objections were raised, the Commission 
Delegated Regulation (EU) 2022/692 was published in the EU Official Journal on 3 May 2022.  
 
67 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 
on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and  1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353 31.12.2008, p. 1), 
consolidated version available at:  
https://eur -lex.europa.eu/legal -content/E N/TXT/?uri=CELEX%3A02008R1272 -20211001   G/TBT/M/87  
 
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  2.1.3.35   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 , G/TBT/N/CHN/1615 , 
G/TBT/N/CHN/1626  (ID 57668) 
2.310.   The delegation of Australia  provided the following statement. Australi a respects the right of 
Members to implement technical measures for legitimate policy purposes and in accordance with 
obligations under the TBT Agreement. Australia remains concerned that measures under China's 
Cosmetics Supervision and Administration Regu lation (CSAR) and its various implementing 
regulations, which entered into force on 1 May 2021, are more stringent than necessary to ensure 
the safety and quality of imported cosmetics. Australia remains concerned that the implementation 
date for the Good Manufacturing Practice (GMP) regulation, as outlined on notification 
G/TBT/N/CHN/1626 , was given by China as effective from 1 January 2022. Australia continues to 
request that China provide a transition period until at least January 2023 for cosmetics 
manufacturers to consider th e regulation's requirements and make adjustments to their processes. 
Australia thanks China for its response to comments on notification G/TBT/N/CHN/1615  on the 
Provisions for the Supervision and Administration of Children Cosmetics. However, Australia remains 
concerned that Chin a has maintained its requirement for mandatory animal testing of cosmetics 
products to be used on children, regardless of the level of risk presented by individual products, and 
reiterates that we are a reliable supplier of high quality and safe cosmetics products domestically, 
and to international markets. The Australian Government stands ready to work with China and 
discuss the CSAR, including subordinate regulations such as those for children's cosmetics.  
2.311.   The delegation of the Republic of Korea  provided the following statement. Specifications for 
Cosmetic Efficacy Claim Evaluation ( G/TBT/N/CHN/1526 ), Specifications for Registration and filing 
of New Cosmetic Ingredients ( G/TBT/N/CHN/1525 ), Specifications for Cosmetic Registration and 
Filing ( G/TBT/N/CHN/1524 ), and Cos metics Supervision and Administration Regulation 
(G/TBT/N/CHN/1310 ) The Republic of Korea appreciates China's response to Korea's comments and 
its bilateral cooperation with Korea on the specifications and regulations under this STC. However, 
Korea remains concerned since China's  response was focused on explaining the implementation of 
the measures rather than providing an answer to Korea's enquiry, and as Korea's concerns were not 
duly addressed in China's finalized specifications and regulations. To begin with, exporters to Chin a 
are required to specify the sources and quality data of all ingredients in their applications, which is 
an excessive requirement compared to international practices. The required information may contain 
trade secrets, and are more than necessary to fulfi ll China's legitimate objectives to ensure product 
safety and compliance to China's domestic market rules. Korea therefore requests China to provide 
an evidence -based explanation for its measures. Furthermore, according to Appendix 12 -14, 
businesses are re quired to disclose information on ingredient safety and this may pose risks to 
companies' intellectual property and commercially sensitive information.  
2.312.   Second, China's regulations stipulate that test reports required for cosmetic product 
registration must be issued by testing laboratories that have obtained the China Metrology 
Accreditation (CMA). During the 2022 March TBT meeting, China replied that a number of foreign 
inspection institutions within the country has obtained the CMA certification. However, Korea 
requests China to offer flexibility by accepting test reports from qualified foreign laboratories located 
overseas. Third, as per Article 13 of the New Cosmetic Ingredients Authorization and Registration 
Regulation, exporters are required to provide evidence that proves their test results of alternative 
test methods are equivalent to the results of in vivo  toxicity testing method, or animal testing. With 
respect to this, Korea would like to request China to recognize alternative test methods approved 
by the OECD or other international organizations without requiring the submission of equivalence 
evidence. In response to Korea's request, China replied that such requirements apply to both 
domestic and overseas exporters but Korea would like to highlight that the concern we expressed 
under this STC is asking China to recognize internationally approved alternative test methods in its 
Regulations.  
2.313.   Fourth, regarding the "Administrative Measures on Cosmetic Labelling, " Korea requests 
China to ensure that label ling requirements comply with international practices. In particular, Korea 
requests China to maintain its current regulation on the requirement of ingredient declaration in 
 
68 For previous statements follow the thread under ID 576 . G/TBT/M/87  
 
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  cosmetic labelling. In most countries, cosmetic ingredients are subject to declara tion when the 
substances are at a 1% or higher concentration. However, China's proposed regulation is not 
harmonized with international practices since it requires substances that are at a 0.1% or higher 
concentration to be declared, and substances at a co ncentration lower than 0.1% to be declared as 
"other trace ingredients ". Fifth, under the Specifications for Cosmetic Efficacy Claim Evaluation, 
China still requires businesses to disclose summarized scientific evidence that supports cosmetic 
efficacy clai ms on NMPA -designated websites. Since these information may contain trade secrets, 
Korea requests China to pare down the information it requires under the Specifications. In the last 
meeting, China responded that trade secrets protection laws will be stric tly complied with when 
managing the registration and filing of cosmetic products. Regarding this, Korea would like to request 
China to provide concrete explanation on the measures taken for compliance.  
2.314.   The delegation of Japan  provided the following stateme nt. With respect to "Cosmetics 
Supervision and Administration Regulation " and its implementing regulations, Japan continues to 
express the following concerns. 1. "Management Rules for Testing required for Cosmetic Product 
Registration and Notification " stipulates that microbiological, physical, chemical, toxicological, and 
human safety and efficacy evaluation tests relevant to cosmetics registration and filing must be 
conducted by the testing laboratories that obtained CMA (China Inspection Body and Laborat ory 
Mandatory Approval). In the previous meetings, China explained that testing laboratories in China 
can obtain CMA. However, we understand that testing laboratories located in foreign countries are 
out of the scope of CMA. Japan would like to request a m ore flexible framework in which test results 
obtained by foreign laboratories with the qualifications and abilities equivalent to those of CMA are 
accepted. 2. "Management Rules for Testing required for Cosmetic Product Registration and 
Notification " stipulates that tests should be conducted in accordance with China's national standards 
or relevant regulations. Moreover, "Specifications for Registration and Filing of New Cosmetic 
Ingredients " and "Specifications for Cosmetic Efficacy Claim Evaluation " stipulate that priority shall 
be given to test results in accordance with China's national standards or relevant regulations and 
that various restrictions and conditions are imposed in the case of conducting a test method which 
is not specified in the regulatio ns. Japan understands the same restrictions and conditions are 
imposed on imported and domestic products. However, Japan would like to request that China treat 
internationally accepted methods such as those from the OECD or ISO as equal to China's national  
standards or relevant regulations, so as not to be more restrictive than necessary in proving safety 
and efficacy.  
2.315.   3. Efficacy claim evaluation method required by "Specifications for Cosmetic Efficacy Claim 
Evaluation " is an excessive requirement for the purpose of guarantee of the scientific validity or 
reliability of efficacy claim evaluation and protection of consumer legal interests for the following 
reasons.  "Attachment 1, Requirements of Cosmetic Efficacy Claim Evaluation item " specifies four (4) 
types of evidence and stipulates in detail which evidence could be used for each efficacy claim. 
However, types of evidence for each efficacy claim should be judged individually by a company based 
on scientific validity.  Even if formula is very similar, use o f "common efficacy claim " evaluation test 
data is only allowed in exceptional circumstances such as colorants are different in the same 
registrants or filers, lines, and multi -shades makeup products. Even if slight changes in formula due 
to regulatory comp liance are made, retests are required. This causes heavy burdens on companies. 
Japan would like to request that China consider expanding the range in which "common efficacy 
claim " evaluation test data can be used based on international trends and stakehold er opinions. 
Regarding the test of freckle -removing/whitening products, Japan would like to request China to 
adopt the approach of "Read-Across ", which allows the test to be omitted under certain conditions, 
that was proposed in Article 16 (freckle -removin g/whitening effect cross -reference) of 
"Specifications for Cosmetic Efficacy Claim Evaluation (Draft for Comments) " in September of 2020. 
Freckle -removing/whitening is affected by active ingredients included in the cosmetics and the Read -
Across approach wi ll help shorten the process from application to permission.  
2.316.   4. Article 29 of "Specifications for Cosmetics Registration and Filing " requires "Cosmetic 
Ingredients Safety Information " issued by an ingredient manufacturer and more detailed information 
than n ecessary for the purpose of ensuring safety and quality of final products is included. 
Requirements for such overly detailed information cause heavy burdens for cosmetic ingredient 
manufacturers. If the information is not submitted, it is assumed that prod ucts already on Chinese 
market can no longer be sold or products distributed in other countries cannot be sold in China. 
Moreover, the consistency between information of the raw materials in cosmetic formula and 
"Cosmetic Ingredients Safety Information " is required. In this regard, when cosmetic companies 
change cosmetic ingredient manufacturers, it is necessary to re -submit or renew the document even G/TBT/M/87  
 
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  if the comparability of quality and safety are confirmed by registrants or filers (cosmetic companies). 
This causes unnecessary burdens for cosmetic companies. Cosmetic companies carry out a safety 
evaluation of the final product based on the quality standard of ingredients set by themselves and 
submit the document at the time of registration or filing. Since it is the cosmetics company's 
responsibility to ensure safety of ingredients and final products including what kind of ingredients 
are used, it is more trade restrictive than necessary to require the submission of "Cosmetic 
Ingredients Safety  Information " issued by cosmetic ingredient manufacturers. Therefore, in the 
same manner as international practice, Japan would like to request that China accept that the 
information of ingredients is submitted when requested by the NMPA after launch, but not at the 
time of registration or filing, or the information of ingredients in accordance with Attachment 14 is 
issued and submitted by cosmetic companies.  
2.317.   5. "Specifications for Cosmetic Efficacy Claim Evaluation " stipulates that regarding cosmetics 
for which application for registration or filing has occurred before 1 May 2022, cosmetic efficacy 
claim evaluation must be conducted and the abstract of an efficacy evaluation of products must be 
uploaded by 1 May 2023. As mentioned in 3, considering that man y conditions and restrictions are 
imposed on evaluation methods, it is practically impossible to complete an efficacy evaluation of 
products and upload the abstract by the deadline. Japan would like to request that China extend an 
adequate grace period of at least one year. "Administrative Measures on Cosmetic Labelling " 
stipulates that applications for registration or filing of products as of 1 May 2022, must be adapted 
to the regulations. It also stipulates that products for which application for registra tion or filing has 
occurred before 1 May 2022, must be adapted to the regulations by 1 May 2023. Registrants or filers 
need detailed rules and guidelines to adapt to the new cosmetic labelling system. Japan would like 
to request that China provide an adequ ate grace period of at least one year after promulgation of 
all relevant regulations. 6. Regarding "Interim Measures on the Administration of Overseas 
Inspections of Cosmetics ", Japan would like to continue to request that China consider the following 
points. Japan would like to request that China clarify which laws and regulations are used to 
determine conformity and specific purposes for conducting overseas inspections. Japan also asks 
that China ensure that inspections will not be more trade restrictive than necessary, ensuring that 
the legitimate objectives under the TBT Agreement are fulfilled. Moreover, Japan requests that China 
ensures that R&D departments of companies should be excluded from the subject of overseas 
inspections and confidential inform ation will not be disclosed to persons other than those who are 
necessary for the legitimate purpose of the inspection.  
2.318.   7. The sales certification that proves the products have been sold on the market in the 
country of production is only imposed on importe d cosmetics. Japan requests that China treat 
imported products no less favourably than products produced in China. Regarding "Administrative 
Measures on Cosmetic Labelling ", which was promulgated on 3 June 2021, Japan would like to 
continue to express its following concerns. 8. Article 6 stipulates that the content of the Chinese 
labels, such as information regarding product safety and efficacy, must be consistent with the 
original labels. Japan appreciates that China continues to accept explanation, in the  Chinese label, 
that the Chinese character "quasi -drug" in the original Japanese label does not mean it is a 
pharmaceutical product, which was also accepted under old regulations. 9. Article 7 requires the 
display of "producers ", "cosmetics registrants or filers" or in the case of imported products, 
"responsible person in China" in the label. Japan has concerns that multiple company names and 
addresses on the label may cause misunderstandings on the part of consumers rather than achieving 
the aims of this a rticle to inform consumers of the persons responsible for product quality and 
efficacy. In order to avoid confusion among consumers, Japan would like to ask that the label should 
indicate only a single responsible person ( "cosmetics registrants or filers " or in the case of imported 
products, "responsible person in China"). Japan would like to request that China delete content that 
requires the display of producers.  
2.319.   10. With respect to the rules for labelling of all ingredients 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 all ingredients of 
0.1% or less must be labelled separately under the title "other trace ingredients" and can be 
described in no particular order. Japan would like to request that China assure that the rules for 
labelling follow the inte rnationally recognized practice so as not to be more trade restrictive than 
necessary. 11. "Specifications for Registration and Filing of New Cosmetic Ingredients " and 
"Specifications for Cosmetics Registration and Filing " stipulates about nano ingredients . To follow 
those regulations, Japan considers that a more detailed and concrete standard is necessary to judge 
which ingredients fall under the definition of nano ingredients. In addition, Japan would like to G/TBT/M/87  
 
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  request that the standard be formulated in a w ay that reflects international trends and comments 
from all stakeholders. 12. "Public notice related matters of Provisions for the Supervision and 
Administration of Cosmetics Production and Distribution " (No. 140, 2021), which was promulgated 
on 26 Novembe r 2021, requires that, regarding products imported to China from overseas 
registrants or filers, domestic responsible persons retain samples of each batch of cosmetics. 
Overseas registrants or filers are responsible for cosmetics. Japan would like to reque st that China 
accept that samples do not have to always be retained in China if the testing system can work 
immediately when problems with imported cosmetics occur. In addition to the above, Japan would 
like to request that China continue to consider the f ollowing points proposed by Japan so far: 
exemption from submitting toxicological testing documents by certification documents on the quality 
management system or good manufacturing practice qualification; use of new toothpaste ingredients 
during the safet y monitoring period; submitting the abstract of an efficacy evaluation report for 
toothpaste  
2.320.   The delegation of the United States  provided the following statement. It is unfortunate that 
despite the United States and other WTO Members raising significant co ncerns with the Cosmetics 
Supervision and Administration Regulation (CSAR) and its implementing measures in the past nine 
TBT Committee meetings and three meetings of the Council on Trade in Goods, China has not sought 
to work with the United States and ot her WTO Members to reach resolution. As published, these 
measures appear to pose significant risks to companies' intellectual property and are not 
proportionate to cosmetics' low risk compared to medical products. We also have serious concerns 
that they ma y accord unequal treatment to imports. We encourage China to show its intent to resolve 
these concerns and to facilitate trade, by meeting with industry and WTO Members to discuss the 
outstanding concerns and to identify a path towards resolution. As noted  in previous statements, 
our top remaining concerns are as follows: First, we remain concerned that the only means China 
provides importers to establish conformity with good manufacturing practices (GMP) requires animal 
testing if an importer's government does not issue GMP or manufacturing export certificates. We 
question China's response that its requirements for imports and domestic products are equivalent. 
The United States reiterates its request that China consider less trade -restrictive means such as 
those previously suggested for importers to demonstrate conformity. For instance, accepting 
conformity with the ISO standard for cosmetics good manufacturing practice (ISO 22716) as 
sufficient to establish compliance with China's regulatory requirements wo uld be far more effective 
than animal testing in establishing compliance with the elements of good manufacturing practice.  
2.321.   Second, the United States remains concerned that CSAR and its implementing measures are 
overly burdensome with respect to the informa tion that companies are required to provide in order 
for Chinese regulators to assess product and ingredient conformity. We are disappointed that China 
will not engage with WTO Members and industry to consider how it might meet its regulatory 
objectives wh ile paring these requirements back. Third, China has failed to address US concerns and 
those of cosmetics intellectual property rights holders, including the request that NMPA provide a 
legally enforceable mechanism to monitor and protect trade secrets and  confidential business 
information (CBI) in cosmetics filings, as identified by companies, within China. Does China have 
any updates in this regard? Fourth, China continues to require duplicative in -country testing to 
assess product claims without consider ing internationally validated methods or data and testing from 
international labs accredited to Good Laboratory Practices or Good Clinical Practices. Allowing foreign 
laboratories with facilities in China to conduct this testing does not address this burde nsome practice. 
Fifth, the United States remains concerned with the cosmetics labelling requirements, as they may 
not allow foreign packaging. We ask that NMPA allow Chinese labelling on the secondary packaging. 
US companies have also requested a means to engage with NMPA on questions arising from CSAR 
implementation, including regarding the new requirements and use of NMPA's new online platforms 
for product and ingredient filings. Does China have any plans for this? We also request that China 
continue to c onsider how these trade concerns expressed by the United States and many other WTO 
Members may be resolved in the implementation of CSAR.  
2.322.   The delegation of the European Union  provided the following statement. The EU would like 
to support the delegations of  Australia, the United States, Korea, and Japan. The EU would like to 
refer to its earlier statements on this topic, in particular to the statement delivered in March TBT 
Committee, as the EU's concerns outlined therein remain unchanged. The European Union  supports 
CSAR's objective of ensuring consumer safety. However there is an important concern pertaining to 
the obligation to transmit confidential information on new products and their ingredients to Chinese 
authorities. The mandatory disclosure of commer cially sensitive information required in the 
notification and registration process, touching on intellectual property rights (IPR) of companies G/TBT/M/87  
 
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  involved, remains EU's biggest concern. The EU needs to stress once more that CSAR's requirements 
go far beyond what is necessary to ensure consumer safety and traceability of the ingredients used 
in cosmetics. It is also diverging from international practice, as such extensive level of information 
is not required elsewhere in the world for notification and registra tion purposes. Unfortunately the 
concerns previously voiced by the EU were not replied to by China.  
2.323.   Therefore the EU would like to recall that the following elements of CSAR legislation pose 
problems to EU cosmetics manufacturers: - Registration of produc ts: Companies must submit a 
complete list of raw materials used in the finished product. Supplier of raw materials must submit 
detailed information on the raw material, including the production process. - Notification for new 
ingredients: There are concern s over the amount of information required under the new notification 
system and potential issues over the disclosure of such information after a certain period. - Efficacy 
claims: manufacturers are required to make public a detailed summary of efficacy eva luation, which 
can reveal business -sensitive information. For certain efficacy claims (sunscreen, skin 
whitening/spot removal, and anti -hair loss), it is still mandatory to use specified Chinese test 
methods. Such tests must be carried out by specific test ing institutions in China. For new efficacies, 
if methods are not yet established in China, they must be validated in at least two qualified testing 
institutions in China to be used to support an efficacy claim in China. Extrapolation of test results 
betwe en very similar formulations is only allowed under exceptional circumstances (i.e. for colour 
ranges of a decorative cosmetic, the efficacy test must only be carried out for every one out of five 
shades). The multiple China -specific requirements for effica cy testing will require significant re -
testing of products for which the efficacy was already established in a third country. This affects also 
many thousands of products that already have been placed on the market in China and for which 
the claim substant iation needed to be completed until May 2022.  
2.324.   The delegation of New Zealand  provided the following statement. New Zealand welcomes 
China's endeavours to modernise its regulatory system for cosmetics and appreciates the 
opportunity to comment on specific el ements of China's Regulations. While we welcome the intention 
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 if a 
government regulatory authority -issued GMP certification is provided. Yet non -special use cosmetics 
are considered to be low -risk products in many countries, in cluding New Zealand, and for this reason 
are not subject to regulator -issued GMP certification. We warmly welcome the introduction of 
alternatives to mandatory animal testing for imported cosmetics. Yet New Zealand, like others, is 
disappointed that the me asures do not provide for non -government regulatory authority -issued GMP 
certification or other trade facilitative mechanisms for providing product assurances, meaning that 
significant and unnecessary barriers to trade for imported cosmetics products still  apply for Members 
who cannot offer regulator -issued GMP certification. We encourage China to engage directly with 
affected Members, including New Zealand, to identify a trade -facilitative mechanism to demonstrate 
GMP conformity, without imposing animal -testing requirements. Specifically, and following China's 
response to New Zealand's question submitted during its recent WTO Trade Policy Review, New 
Zealand seeks clarification whether the requirement for a regu -issued GMP certificate as an 
alternative to a nimal testing requirements can be exempted on the basis that: the manufacture of 
the product fully conforms with the relevant ISO 22716 standard or higher, assuring the safety of 
the product, or a product safety risk assessment result is provided from a la boratory accredited by 
a National Accreditation Body that confirms the safety of the product.  
2.325.   Additionally, New Zealand requests that China also provide flexibility in respect of product 
testing requirements. In particular, we encourage China to accept tes t reports from laboratories 
situated outside of China that have been accredited by ILAC Mutual Recognition Arrangement 
signatories. Otherwise, this is a burdensome and unnecessary trade barrier for exporters that send 
products to China as well as multiple other markets. Building in such flexibility 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, that China requires more detailed disclosure of pro duct 
formulas than is required in other markets, including specific sources of each ingredient. New 
Zealand encourages China to limit such disclosure requirements, particularly in relation to sensitive 
information, to that which is required to assure produ ct safety in China's domestic market, so as not 
to compromise intellectual property. New Zealand appreciates our recent constructive bilateral 
engagement on cosmetics issues and looks forward to engaging further with China on its CSAR 
measures to address t hese issues. We would welcome China's response to the concerns raised by 
New Zealand and other Members in this and other fora.  G/TBT/M/87  
 
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  2.326.   In response, the delegation of China  provided the following statement. 1. The protection of 
trade secrets. Submission of cosmetic s safety -related information is a common requirement for 
health -related product safety reviews worldwide. The production process description, raw material 
production process and other registration and filing materials in the product implementation 
standard s submitted by enterprises are not the contents of government information disclosure. 
According to the Regulations on the Disclosure of Government Information, administrative agencies 
are not allowed to disclose information involving trade secrets and pers onal privacy harming 
legitimate rights and interests. Therefore, trade secrets and intellectual property rights are not 
damaged in this regard. China attaches great importance to the protection of trade secrets. 
Cosmetics regulations require regulators to keep trade secrets when reviewing and releasing 
information. NMPA, will strictly abide by the principle of protecting the trade secrets during the 
registration and filing of cosmetics. 2. The problem of cosmetic label labelling. First, the Measures 
for the  Administration of Cosmetics Labels do not require all contents of Chinese labels to be 
consistent with those of the original packaging labels. The requirement is that the contents of product 
safety and efficacy claims should be consistent with those of th e original labels.  
2.327.   3. The claimed efficacy of cosmetics is closely related to the ingredients used. In order to 
protect the legitimate rights and interests of consumers, preventing "conceptual addition" which is 
common in the industry, the Measures for the  Administration of Cosmetics Labels (Draft for 
Comments) proposed that ingredients with formula content less than 0.1% (W/W) should be marked 
with "other trace ingredients" as the guidance language. However, "other trace ingredients" is not 
the same as "in valid ingredients", cosmetic enterprises add a very low amount of raw materials 
which still have certain effects, that can be declared in the product label upon fulfilling the relevant 
requirements for efficacy claims. 4. The cosmetics inspection reports r equired for registration or 
filing shall be issued by the cosmetics registration and filing inspection institution to protect the 
legitimate rights and interests of consumers and to ensure the accuracy of the inspection results. 
Cosmetics used for whitenin g, sun protection, and hair loss prevention are administrated as special 
cosmetics in China. The efficacy evaluation test report of such products should be submitted at the 
time of product registration. Therefore, an efficacy evaluation test should be comp leted in cosmetics 
registration and filing inspection institution. The institutions should obtain cosmetics inspection and 
testing (CMA) certification. However, China does not prohibit foreign inspection institutions from 
becoming cosmetic registration and  filing inspection institutions. At present, many laboratories of 
foreign inspection institutions located in China have obtained COSMETIC CMA and undertaken 
cosmetic registration and filing inspections.  
2.328.   5. For the exemption of toxicology tests. Firstly, fo llowing the principle of non -discrimination, 
the Administrative regulations of Cosmetics Registration and Filing Materials set up consistent 
requirements on imported and domestic cosmetics, for alternatives for animal testing in safety 
evaluation. For both  domestic and imported ordinary cosmetics, while obtaining the relevant 
production quality management certification issued by government authorities, with the proper 
safety risk assessment, the toxicology test can be exempted. Secondly, as the skin structu re and 
immune system function of growing infants and children are not perfect, safety assessment only 
may leave some unknown risks. Moreover, many safety assessment data come from cosmetics of 
the general population, and the direct assessment of children's  cosmetics is not sufficient. Therefore, 
China believes that children's cosmetics should be evaluated for product safety through both safety 
assessment and necessary toxicological tests. 6. The basic principles and requirements in "Good 
Practice for The Pr oduction quality Management of Cosmetics" are consistent with that in ISO 22716. 
It is in line with international prevailing requirements, aiming to standardize the production quality 
management of cosmetics in China, and to ensure cosmetics safety.  
2.329.   7. On the transitional period for the implementation of regulations. Based on the industrial 
situation and regulatory requirements, China has set up a specific and reasonable transitional period 
for different situations, so as to ensure the smooth and orderly im plementation of the new 
regulations. While the formulation and implementation of follow -up regulations and technical 
documents are in process, a reasonable transitional period will also be provided accordingly, so as 
to ensure a smooth transition between t he old and new regulations. 8. Submission of information 
related to the safety of cosmetic raw materials. Product safety is closely related to the safety of raw 
materials. Provision of information related to the safety of raw materials when applying for 
registration and filing is an important measure to ensure product safety. Considering that it is 
common for enterprises to change the raw material, in order to facilitate cosmetics registrants and 
record holders to fill in the information related to raw mate rial safety, Provisions on the Management 
of Cosmetics Registration and Record Materials stipulate that if the raw material  manufacturer has G/TBT/M/87  
 
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  submitted the information related to raw material safety, the registrants and record holders only 
need to provide t he raw material submission code for correlation. 9. The retention sample of 
imported cosmetics. The purpose of the sample retention system is to ensure the traceability of 
product quality and safety and to facilitate the inspection of the legitimacy and sa fety of each batch 
of products in the case of quality and safety problems and counterfeit products.  
2.1.3.36   European Union - Chlorothalonil (pesticide active substance), G/TBT/N/EU/625  
(ID 57969) 
2.330.   The delegation of Colombia  provided the following statement. Colombia reiterates its concern 
regarding the measure notified by the European Union in document G/TBT/N/EU/625  relating to 
non-renewal of the approval of the active substance chlorothalonil. Despite the many technical and 
scientific comments submitted within the consultation periods, the regulation under which the 
marketing approval of the active substance 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 an extensive domestic  agricultural production 
chain. 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. This provision entered 
into force on 2  September  2021. In this case, the EU has also failed 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. Not only are these measu res 
being taken in a manner that is inconsistent with international standards such as those of the Codex, 
but they are also being applied in a discriminatory fashion, as, in practice, their implementation and 
authorization for use differentiate between dom estic and foreign producers. This is so in the case of 
"emergency authorizations", which allow EU producers to continue or resume the use of pesticide 
substances.  
2.331.   While we recognize the health and environmental protection objectives involved, these 
measure s are being adopted without any proof that they are indeed the least trade -restrictive means 
of ensuring an appropriate level of protection for consumers, which constitutes a violation of Article 
2.2 of the TBT Agreement. The measures adopted must be based  on scientific evidence and 
international standards and take account of the biodiverse agriculture of tropical countries such as 
Colombia. Furthermore, producers and exporters have questions and concerns regarding inspection 
and control mechanisms and proc edures. The EU has failed to provide clear answers on how to make 
carrying out foreign trade operations more predictable, on inspection mechanisms, or to 
demonstrate compliance with requirements. We request the European authorities to provide further 
information on these matters to ensure that they are not trade -restrictive measures.  
2.332.   The delegation of Paraguay  provided the following statement.  This concern and the non -
renewal of the approval of chlorothalonil and other substances was already discussed extensively 
both in this Committee and in the SPS Committee because of the subsequent reduction of MRLs. 
Paraguay therefore refers to its previous  statements and requests that its statement at the previous 
meeting be reflected in full in the minutes of this meeting. We once again request that the European 
Union take into consideration information on pesticides provided by the specialized agencies 
recognized by the WTO, such as the Codex Alimentarius, reconsider its approach and base its 
decisions on conclusive scientific evidence and real risk weightings, in accordance with international 
standards and principles, and ensure import tolerances.  
2.333.   The del egation of Brazil  provided the following statement. Brazil supports STC 579 and refers 
to its previous statements on the matter. We believe that the EU's decision to base measures on a 
hazard -based approach, without an adequate risk analysis and with no co mpliance with long -
standing scientific principles is inconsistent with WTO rules. The non -renewal of approval for 
chlorothalonil by the EU did not duly consider that it is currently authorized in more than 100 
countries, and that the MRLs allowed by Codex could reach up to 70 mg/kg. We stress our systemic 
concern with the fact that some hazard -based analyses conducted by the European Food Safety 
Agency (EFSA) led to the non -renewal of approvals of some substances and subsequently to the 
reduction of their M RLs. 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.  
 
69 For previous statements follow the thread under ID 579 . G/TBT/M/87  
 
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  2.334.   The d elegation of Costa Rica  provided the following statement. Costa Rica once again 
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 thanks the EU for its willingness to hold a dialogue 
on agrochemicals policy, taking into consideration international obligations on foreign trade and the 
agricultural and environmental policy objectives of the member countries of the international 
community, together with the commitment to leave no one behind in the implementation of its Green 
Deal policy.  
2.335.   The delegation of Guatemala  provided the following statement. Guatemala maintains its 
position on this concern, es pecially because there is no information on scientific evidence of the 
possible damage to human health caused by consuming fruits and vegetables, particularly those 
produced in Latin America. We therefore reiterate the importance of conducting a risk analy sis. 
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 
molecule on the market is currently as effective for cont rolling the Ascochyta  fungus, above all in 
vegetables. Guatemala's climatic conditions provide this fungus with the ideal environment to 
reproduce, affecting crops, which have been seriously harmed, and the economy of Guatemalan 
producers and exporters  to the European market . Alternative substances to chlorothalonil include: 
mancozeb, azoxystrobin, pyraclostrobin, sulphur and difenoconazole. The registration of four of 
these alternative substances was not renewed for marketing in the European Union, and, as  a result, 
MRLs have been reduced to almost zero tolerance, leaving Guatemalan agricultural production with 
no options that can effectively combat diseases of fungal origin.  
2.336.   Unlike European countries, Guatemala is geographically located in the tropics, whe re there 
are only two seasons: one rainy and one dry. This provides an ideal climate for pests and diseases 
to spread throughout the year. As a result, it is almost a certainty that fungi will grow and damage 
crops. The country is one of the world's leadin g producers of non -traditional vegetables. In 2019, 
32 million  kilograms (70  million pounds) of peas and 29.5  million kilograms (65  million pounds) of 
green beans were produced, making it one of the main exporters of these crops to the 
European  Union. The momentum and growth of the sector have helped improve the quality of life of 
more than 60,000 families in around 200 of Guatemala's rural communities that make up the sector's 
production base, generating around 20,000 jobs. Guatemala's banana exports accou nt for 30 % of 
total exports of traditional products from the customs territory. The banana is the world's most 
consumed and exported fruit. The crops provide over 280,000 direct and indirect jobs. Any changes 
to their production cycle resulting from an inc rease in disease due to a lack of alternative substances 
would affect over 1,120,000 Guatemalans (Independent Banana Producers' Association (APIB)).  
2.337.   For all of the above reasons, we ask the European Union to consider the similar 
circumstances of tropical c ountries when implementing measures, until it has conclusive studies and 
has aligned itself with the provisions of the Codex Alimentarius. Guatemala therefore requests that:  
The risk assessment approach and scientific evidence be considered;  MRLs that corr espond to the 
reality of tropical countries be set. Tropical countries cannot be required to use the same treatments 
as European countries, since their climatic conditions are different. For this reason, we ask that the 
MRLs for chlorothalonil be reviewed,  taking into account that no chemical substance on the market 
can replace this compound and effectively control the Ascochyta  fungus.  Scientifically -based 
information be provided showing that fruit and vegetables exported from Guatemala or third 
countries to the European Union are harmful to the health of consumers from these countries.  
2.338.   The delegation 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 use of the active 
substance chlo rothalonil and document SANTE/10186/2018 Rev.1, through which the EU confirms 
the non -renewal of the use of this substance.  Chlorothalonil is one of the main tools for controlling 
Black Sigatoka in bananas thanks to its effectiveness, low cost and multisit e 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 banan a 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 sc hedules. Restricting 
the use of chlorothalonil will further 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 G/TBT/M/87  
 
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  of document G/SPS/N/EU/394/Add.1 , dated 12  February  2021, pursuant to which new MRLs came 
into force for various active substances, including chlorothalonil.  
2.339.   Ecuador urges the European Union to consider third country comments on notifications 
before implementing substance reductions that significant ly affect the availability of pest control 
options for production in tropical and subtropical areas. For an MRL to be banned or lowered, there 
must be conclusive scientific information demonstrating a real health impact.  Reducing the MRL for 
chlorothalonil  could have a very significant economic impact on small -, medium -, and large -scale 
producers in Ecuador. This is because the banana sector provides jobs for 2.5  million people. Exports 
of this product account for a significant share of the country's foreig n exchange earnings (2.1  billion). 
This equates to 2 % of GDP and 35 % of agricultural GDP.  Moreover, we wish to recall that no 
substitute or similar phytosanitary products with the same environmental or toxicological profile are 
currently available, since t he alternatives to chlorothalonil (mancozeb, metiram) are already under 
review by the EU.  
2.340.   In response, the delegation of the European Union  provided the following statement. As 
explained at previous meetings, the EU proposed not to renew the approval of chlorothalonil through 
Commission Implementing Regulation (EU) No 2019/67770, adopted on 29 April 2019 and previously 
notified to the TBT Committee. Following the non -renewal of 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 MR Ls for chlorothalonil to the relevant limits of quantification through Commission 
Regulation (EU) 2021/15571 of 9 February 2021. The new values are applicable to all food products 
since 2 September 2021. Since then, there has been no further developments i n the EU on this 
substance, as not new data were received. Import tolerance requests, which need to be supported 
by substantial new data addressing the concerns, remain possible and will be assessed on a case -
by-case basis by the "rapporteur " member State and the EFSA.  
2.1.3.37   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA (ID 61872) 
2.341.   The delegation of Colombia  provided the following statement. Colombia thanks Peru for its 
considerati on of the concern regarding the use of adhesive advertising warning labels set out in 
paragraph 8.3 of the Manual of Advertising Warnings approved by Supreme Decree No. 012 -2018-
SA. However, we are raising this STC once again, given that DS No. 005 -2022-SA extended the 
deadline for the use of adhesive labels to 31  December  2022. As we are now approaching that date, 
business owners and trade operators still have many outstanding concerns and questions. Colombia 
requests that the option to use adhesive labels  be permitted indefinitely and that the deadline should 
not continue to be extended for further periods of time. Furthermore, Colombia considers that the 
policy under which this standard is being adopted, while understandably seeking to promote and 
protect  public health, should be implemented in a manner that is no more restrictive than necessary 
and does not subsequently create an unnecessary obstacle to trade. To do otherwise would render 
the measure inconsistent with Article 2.2 of the WTO  Agreement on T echnical Barriers to Trade. It 
also emphasizes that allowing the use of adhesive labels does not distort the purpose of the Peruvian 
standard, since the warnings, whether included on adhesive labels or printed directly on product 
packaging, will continue t o be clear, legible, prominent and comprehensible, as required by the 
regulations. Similarly, this technical measure on labelling that is so specific to a particular country 
primarily affects small and medium -sized enterprises, creating distribution -relate d logistical 
disadvantages, as establishments generally require compliance with the standards months in 
advance to ensure that at the time of sale to the final consumer they are being complied with. Lastly, 
we welcome the bilateral talks that have taken pl ace at different levels, and the new developments 
reported by the Peruvian authorities. We also invite you to continue working in a coordinated manner 
 
70 Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non -renewal of 
the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the market and 
amending Commission Implementing Regulation (EU) No 540/2011. OJ L 114, 30.04.2019, p. 15.  
71 Commission Regulation (EU) 2021/155 of 9 February 2021 amending Annexes II, III and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue 
levels for carbon tetrachloride, chlorothalonil, chlorpropham, dim ethoate, ethoprophos, fenamidone, 
methiocarb, omethoate, propiconazole and pymetrozine in or on certain products. OJ L 46, 10.2.2021, p. 5.  
72 For previous statements follow the thread under ID 618 . G/TBT/M/87  
 
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  and to take into account the above -mentioned considerations, allowing the use of adhesives 
indefinitely t o avoid measures that restrict and affect trade.  
2.342.   The delegation 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 b y 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 
standar d 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 long as they are attached to the packaging 
and if the language of the original label is not necessarily t hat of the consumer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that help to better inform consumers. Despite Peruvian legitimate concerns with 
deceptive practices, advances i n labelling technologies allow for their safe affixation. We 
acknowledge that, according to Supreme Decree 005 -2022-SA, the entry into force of the prohibition 
on stickers was delayed until 31 December 2022. However, Brazil would like to respectfully ask P eru 
to permanently align its labelling requirements with current international standards established 
under the Codex and withdraw the prohibition of stickers for the products under the scope of the 
Manual of Advertising Warnings. Brazil considers such post ponement a provisional solution and will 
continue to raise this STC until Peru permanently removes its burdensome requirements for food 
labelling.  
2.343.   The delegation of the European Union  provided the following statement. The European Union 
appreciates that Pe ru further extended the possibility for imported products to use stickers for 
compliance with labelling requirements for processed foods, until 31 December 2022. However, the 
EU would like to repeat once again the urgent invitation to Peru to provide for a  permanent possibility 
for imported products to use stickers. The repeated and unforeseeable extensions of the deadline 
severely disrupt trade because retailers in the Peruvian market stop buying products with stickers 
several month before each deadline. S uch disruptions represent significant losses for importers and 
producers, as well as disruption of trade flows and unavailability of the affected products in the 
Peruvian market. The EU recognizes that reliable information to the Peruvian consumer and 
protection of public health are legitimate objectives. Nevertheless, the obligation to print information 
on the product package is unnecessarily 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. We invite once again Peru to bilaterally work with the EU on this issue.  
2.344.   The delegation 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 international 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 prod ucts 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 internationally, as it f ulfils 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.  
2.345.   The delegation of Paraguay  provided the following s tatement. We thank Colombia, Brazil and 
the European Union for placing this trade concern on the agenda and request that Paraguay's support 
also be recorded. Paraguay supports Peru's objective of protecting public health and considers that 
the provision of  information to consumers through labelling 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. It should be noted that the use of labels of this kind 
is widely recognized internationally, as such labels achieve the same public health protection and 
consumer information purposes achieved by permanent labels. Not accepting them is therefore more 
trade -restrictive than necessary. We tha nk Peru for the information received and for extending the 
grace period until 31  December this year. While we appreciate this decision, it will not solve the 
underlying problems that our exporters will face. We therefore ask Peru to review this measure and  
to bear in mind the provisions of Article  2.2 of the TBT Agreement.  G/TBT/M/87  
 
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  2.346.   The delegation of Chile provided the following statement. Chile would like to state that it 
shares the legitimate public policy objective pursued. However, the regulations established in 
Supreme Decree No. 015 -2019-SA, which amends the Manual of Advertising Warnings approved by 
Peru, has caused concern among companies and guilds exporting packaged foods to that country, 
as the acceptance of sticker -based labelling is temporary. Chile would  be grateful if Peru 
reconsidered the established extension period, allowing the use of adhesive labels to be permanent.  
2.347.   The delegation of Costa Rica  provided the following statement. Costa Rica wishes to reiterate 
its trade concern 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 of Peru. The food industry has informed us of the 
negative repercussi ons on trade that a potential discontinuation of the use of adhesive labels would 
entail. It should be noted that the use of adhesive labels is widely recognized internationally, as such 
labels achieve the same public health protection and consumer informa tion purposes achieved by 
permanent labels. At the CODEX level, for example, Articles 8.1.1 and 8.2.1 of CODEX -STAN  1-1985 
– General Standard for the Labelling of Prepackaged Foods, permit the use of supplementary and 
adhesive labels, as long as it is guar anteed that they will not become separated from the container, 
or in cases where the language on the original label is not suitable for the consumer for whom it is 
intended. Costa Rica respectfully requests 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. In view of the above, we respectfully restate Costa 
Rica's wish that the Peruvian authorities remove the pro posal to prohibit the use of stickers and 
maintain the possibility of permitting their permanent use. We request the Peruvian authorities to 
provide information on the status of this Regulation, whether the intention is still to ban the use of 
stickers on labels and the timing of the Regulation's entry into force.  
2.348.   In response, the delegation of Peru provided the following statement. Peru reiterates 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 area. In this connection, Peru is seeking to ensure 
that the information contained in the Manual of Advertising  Warnings (MAP) reaches consumers 
clearly and effectively to enable them to make informed choices.  As stated at the previous 
Committee meeting, Peru, in response to the concerns expressed by some Members and by means 
of Supreme  Decree  No. 005-2022-SA, exte nded again, until 31  December  2022, the period during 
which the use of adhesive warning labels is allowed, as 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 
healthy eat ing among children and adolescents.  Furthermore, it should be noted that the Peruvian 
Ministry of Health is carrying out the relevant assessments of the matter in order to find a definitive 
solution in the near future.  
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 established in the Agreement on Technical Barriers to Trade.  
2.1.3.38   Kingdom of Sau di Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program (ID 61573) 
2.349.   The delegation of the European Union  provided the following statement. The implementation 
of the electronic certification system SALEEM through the web -portal SABER remains a concern for 
the European Union. While we would like to thank the Kingdom of Saudi Arabia for engaging 
constructively in bilateral talks and providing some explanations, the difficulties still have a major 
negative impact on the imports of several products from the European Union to Saudi Arabia. Several 
European industries coincide in reporting the overly costly, burdens ome and time -consuming nature 
of the conformity assessment requirements. The sector of toys is particularly affected. European toy 
manufacturers continue to report difficulties related to obtaining a GCC Conformity Tracking Symbol 
(so-called GCTS) from not ified bodies authorized by Saudi Standards, Metrology and Quality 
Organisation (SASO). The EU refers to its previous statement but would like to recall that the main 
concerns are related to the following issues: (i)  request of test reports; (ii) selection of 
representative item; (ii) extension of the validity of certificate; and (iv) products imported without 
GCTS (GCC Conformity Tracking Symbol). In addition, European companies report serious difficulties 
 
73 For previous statements follow the thread under ID 615 . G/TBT/M/87  
 
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  in relation to toys for older children as they are not considered as toys as such and it is impossible 
to import them through "toy" tariff codes and they don't have a GCTS. On the procedures to obtain 
the GCTS for toys, there is some small progress. The European Union appreciates that a regular 
dialogue be tween GSO, Manufacturers and Testing labs (Notified Bodies) has started. However, any 
practical agreement still needs to be approved by the GCC member states before Guidance can be 
adopted. In conclusion, the European Union invites the Kingdom of Saudi Ara bia to address these 
concerns and ensure efficient and less costly procedures for all products included in the new 
conformity assessment system. The European Union remains available to continue bilateral 
discussions.  
2.350.   The delegation of Canada  provided the f ollowing statement. Canada supports Saudi Arabia's 
goal of creating an integrated system that efficiently assesses the safety of imported products. 
Industry stakeholders also support SABER, however, issues continue to persist regarding its 
implementation. Canada has raised some of these concerns at previous TBT Committee meetings. 
Industry stakeholders voice that problems include inconsistent application of the requirement by 
notified bodies and some Saudi Standards, Metrology and Quality Organization (SASO ) issues are 
intertwined with the Standardization Organization for the Cooperation Council for the Arab States of 
the Gulf (GSO) requirements. These issues continue to pose unnecessary administrative burden, 
costs and duplicative requirements for stakehold ers. We understand the Notified Bodies are working 
to try and help resolve these issues. We also are aware that some working group meetings among 
Notified Bodies, GSO, and industry representatives have already taken place. And industry is quite 
encouraged by this engagement on the part of Saudi Arabia especially given that some issues require 
direct action by SASO and GSO. Canada kindly asks Saudi Arabia's consideration of providing more 
detailed guidance to Notified Bodies on how to implement the SABER pla tform in order to increase 
the efficiency of the system, reduce compliance costs and ensure consistency.  
2.351.   The delegation of Switzerland  provided the following statement. Switzerland remains 
concerned over the negative impact of the "Saber Conformity Assessm ent Online Platform " on 
bilateral trade with the Kingdom of Saudi Arabia. We would like to support the intervention made by 
previous speakers on this matter. The registration and certification process seems to remain non -
transparent, complex and time -consu ming for our exporters. The industry continues to report that 
the conformity assessment procedures lead to disproportionate fees and in many cases to 
unnecessary administrative burden, costs and duplicative requirements. In particular for companies 
exporti ng quality products in small quantities, this additional burden is prohibitive to enter the 
market. Switzerland would appreciate if the Kingdom of Saudi Arabia could ensure that the 
registration and certification process is not more strict than necessary t o give adequate confidence 
that products fulfil the applicable requirements. Furthermore, we encourage the Kingdom of Saudi 
Arabia to base the documentation and certification requirements on international standards, to 
implement clear and transparent guide lines and to ensure that the requirements are applied in an 
equal and uniform manner. Switzerland looks forward to further cooperation on this matter.  
2.352.   In response, the delegation of the Kingdom of Saudi Arabia  provided the following statement. 
Saudi Arabia  thanks the European Union, Canada and Switzerland for raising concerns regarding 
Saber Conformity Assessment Online Platform / Saleem Product Safety Program and GCC Technical 
Regulation on Children Toys. "Saber" is an IT Platform that aims to improve the import experience 
by easing the Conformity process/procedure before the arrival of the shipment. Hence, it is not 
considered a technical measure under the jurisdiction of TBT/WTO rules. Therefore, the notification 
process is not required according to the T BT Agreement. According to the TBT/WTO agreement, all 
Technical Regulations reflected in "Saber" are notified by SASO to all WTO Members through 
(SPS/TBT E -Ping Platform). Saber itself does not impose additional policies or requirements other 
than those me ntioned in the notified technical regulation. "Saber" has contributed to facilitating and 
enhancing trade, reducing the cost and time of custom clearance to 1 -7 working days compared to 
7-15 working days in previous years. As a result, the Kingdom's rankin g in the cross -border trade 
index advanced 72 ranks, confirming SASO's commitment to boosting trade facilitation. Regarding 
GSO toy regulation, the second version was approved in 2013, and the GCC member states have 
started to implement it in the interest of the safety of children whose age is less than 14 years.  
2.353.   The GCC Standardization Organization accepted many notified bodies worldwide to facilitate 
the application of the children's toys regulation requirements. In the other hand, the E -platform 
"SABER"  does not require additional certificates of conformity as long as the GCC certificate of 
conformity is valid, therefore, processing shipment certificates through the "Saber " platform would 
be fast and easy. We would also like to point out that the validit y of the GCC conformity certificates G/TBT/M/87  
 
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  lasts for three years, and then the conformity procedure is considered fair. Concerning toys for 
people over 14 years old, which are excluded from the scope of the GCC regulation, the Supplier 
Conformity Declaration thr ough "SABER" only is sufficient. The GSO, along with SASO and other 
GCC competent authorities, held several opening meetings (the last meeting was held in June 2022) 
with manufacturers, distributors, exporters, and CBs to discuss all issues and concerns fa cing the 
toys industry. All Europe toys industry are invited to these activities to address any challenges they 
might encounter. In conclusion, Saudi Arabia is always happy to collaborate and engage with all 
stakeholders, and we look forward to further coo peration on these matters.  
2.1.3.39   Colombia - Food Prioritized for its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1  (ID 60974) 
2.354.   The delegation of Costa Rica  provided the following statement. First of all, Costa Rica would 
like to express its appreciation for the effo rts of the Colombian authorities to provide information 
related to its regulation on front -of-pack nutrition labelling for foods high in sodium. In this regard, 
we note that we have received information on the reasons and justification for this Colombian 
regulation. However, Costa Rica would like to take this opportunity to emphasize the importance of 
harmonizing food labelling schemes, in particular front -of-pack nutrition labelling, on the basis of 
Codex regulations (Guidelines on Nutrition Labelling CXG -2-1985, Annex 2, adopted in 2021). In 
this regard, we encourage the use of the recently approved Codex guidance on the subject as a 
reference to ensure that regulations are consistent with the international consensus and do not 
establish unnecessary restri ctions on trade.  
2.355.   The delegation of Guatemala  provided the following statement. Guatemala wishes to thank 
Costa Rica for including this item on the agenda. We reiterate the recognition of the legitimate 
objective of the Colombian Government to ensure human health, and the efforts made to lower total 
sodium intake in Colombia in order to reduce hypertension and other related diseases.  With regard 
to the latest report of the Committee on Technical Barriers to Trade, Guatemala thanks the 
Government of Colombia for providing an explanation of this notification. It is stated that first -party 
certificates of conformity will be accepted up to 24 months after a certification body is accredited in 
Colombia, as required by the regulations. Given that this certificate o f conformity must be presented 
for each import, we would like to ask Colombia about steps to be taken should the manufacturing 
company consistently demonstrate regulatory compliance.  
2.356.   The delegation of Paraguay  provided the following statement. We thank Costa Rica for 
including this trade concern on the agenda and request that Paraguay's support be recorded. 
Paraguay recognizes and supports the right of the Republic of Colombia to protect the health of its 
popul ation by limiting the sodium content of some foods as part of efforts to protect against chronic 
non-communicable diseases. However, Paraguay is concerned that the provision of lot -by-lot 
certificates of conformity would be burdensome and costly for import ers and more restrictive than 
necessary to achieve the legitimate objective pursued by Colombia with this measure.  
2.357.   In response, the delegation of Colombia  provided the following statement. The competent  
authorities in Colombia have had productive exchanges  which have made it possible to clarify a 
number of the issues that gave rise to this trade concern. We have also shared relevant information 
on the reasoning behind this regulation on the eAgenda system. Our authorities remain open to 
dialogue and we will  leverage the necessary responses to facilitate compliance with the new 
regulations. We have taken note of the new comments and expect to provide the countries with a 
response shortly. Colombia welcomes the comments shared by Costa Rica and the statements made 
by Guatemala and Paraguay, and reiterates that Resolution No.  2013 of 2020 was issued for public 
health reasons and is part of a comprehensive strategy that takes into account both the sodium 
content of processed foods and other sources of sodium, suc h as the salt added to food preparations 
in restaurants, at home and in institutions. This is the National Strategy for the Reduction of 
Sodium/Salt Consumption 2012 –2021. The strategy seeks to reduce mortality attributable to high 
blood pressure and cardi ovascular 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.  
2.358.   With regard to concerns about the technical and functional role of sodium in the production 
of prioritized foods, Colombia wishes to reiterate that this aspect was analysed at all of the technical 
 
74 For previous statements follow the thread under ID 609 . G/TBT/M/87  
 
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  meetings for the 12 categories of food with industry, academic and government representatives, 
resulting in agreement on, and the dissemination of, the draft regulations. The following documents 
shared by Colombia were produced by the Ministry of Health and Social Welfare and provide support 
for the measures taken through Resolution No.  2013 of 2020 on the maximum sodium content for 
processed foods.75 Colombia would like to point out that the relevant authorities have expressed 
their willingness to hold technical discussions with the Costa Rican authorities in order to address 
the concerns raised and ensure compliance with the tec hnical regulations on the maximum sodium 
content for processed foods. We therefore reiterate our willingness to address this issue bilaterally, 
so as to facilitate the technical analysis by the relevant authorities of the parties. We will review the 
commen ts made in this connection by delegations in order to address the questions raised and 
provide information to facilitate compliance.  
2.1.3.40   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of p re-packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9  (ID 60876) 
2.359.   The delegation of Costa Rica  provided the following statement. Costa Rica would like to take 
this opportunity to emphasize the importance of harmonizing food labelling schemes, in particular 
front-of-pack nutrition labelling, on the basis of Codex regulations (Guidelines on Nutrition Labelling 
CXG-2-1985, Annex 2, adopted in 2021). In this regard, we encourage the use of the recently 
approved Codex guidance on the subject as a reference to ensur e that regulations are consistent 
with the international consensus and do not establish unnecessary restrictions on trade.  
2.360.   The delegation of Guatemala  provided the following statement. We recognize Mexico's right 
to protect people's health and to provide c onsumers with information on the food they buy. We 
thank Mexico for the response it provided during the previous meeting, which was confirmed in the 
report of the meeting, in particular its indication that there is no expiry date for the use of a 
supplemen tary label as a permanent mechanism. 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 transitional provisions at the end of the pu blication. 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 Foo ds, authorizes the use of a supplementary label that 
fully and accurately reflects the information contained on the original label.  
2.361.   The delegation of Paraguay  provided the following statement. We thank Costa Rica for 
including this trade concern on the agenda and request that Paraguay's support be recorded. 
Paraguay supports Mexico's goal of protecting public health and considers that the provision of 
nutritional information to consumers is an appropriate strategy. However, Paraguay shares the 
concern of  other countries over the mandatory declaration of added sugar, which is not provided for 
under Codex guidelines. Paraguay is also concerned that there is no analytical method for 
distinguishing total sugars from added sugars, which would render enforcemen t difficult, since this 
would depend on the information provided by the industry.  
2.362.   In response, the delegation of Mexico  provided the following statement. As has been 
previously mentioned by Mexico, we are aware that international schemes for the labelling of foods 
now exist under Annex 2 to the Codex Alimentarius Guidelines on Nutrition Labelling (CXG -2-1985), 
adopted in 2021. However, at the time NOM -051 was being prepared, there were no international 
reference standards that could be used as a basis for e stablishing front -of-pack labelling for pre -
packaged food and non -alcoholic beverages. The adoption, modification and/or annulment of 
technical regulations in Mexico are governed by the standardization process, time -frames and stages 
established under the Law on Quality Infrastructure, as well as under the General Law on Regulatory 
Improvement, which includes a regulatory impact analysis applicable to Mexican Official Standards. 
The Government of Mexico reiterates its responsibility to comply with the inter national commitments 
 
75 National Strategy for the Reduction of Sodium/Salt Consumption 2012 –2021 
Available at: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/PP/SNA/Estrategia -
reduccion -sal-2012-2021.pdf   
Regulatory impact analysis of the draft resolution defining the maximum sodium content for prioritized 
foods  
Availabl e at: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/PP/SNA/analisis -
impacto -normativo -sodio.pdf  
76 For previous statements follow the thread under ID 608 . G/TBT/M/87  
 
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  set out in the Agreement on Technical Barriers to Trade and those relative to the free trade 
agreements to which Mexico is party, as well as to constantly harmonize technical regulations with 
international parameters, recognizing the l egitimate objective of public policy to safeguard the 
population's health generally.  
2.363.   The Chair  noted that the Committee was running out of time.77 He encouraged Members to 
keep their interventions short and suggested that Members that had uploaded their st atements on 
eAgenda simply refer to them rather than reading them out. The Secretariat would ensure that the 
full content of the statement would be recorded in the minutes of the meeting even if it had not 
been read out.  
2.364.   The Secretariat  confirmed that this  could be done.  
2.365.   The representative of the United States  noted that they would carry out the Chair's 
suggestion on a voluntary and case -by-case basis, depending on the importance of the particular 
STC. The United States stressed the tremendous amount of ti me spent in the preparation and vetting 
of questions in advance of the STC discussion and expressed some concern about the notion of 
limited time being a reason not to fully express an STC, and only referring to eAgenda.  
2.366.   The Chair  confirmed that the propos al was voluntary in nature; Members retained the right, 
of course, to read out the full statement.  
2.367.   The representative of Colombia  also stated that it would refer to eAgenda on a voluntary 
basis. She highlighted the importance of dealing in a detailed mann er with the STCs, as in many 
cases new elements and questions were raised, despite a lack of change in the responses over time.  
2.368.   The representative of Canada  suggested that the Chair could encourage Members to use a 
certain time limit in which to intervene  rather than simply referring to statements in eAgenda.  
2.369.   Whilst  acknowledging the time constraints of the Committee, Chile, Paraguay , and Uruguay  
reserved the right to intervene to the extent necessary.  
2.1.3.41   Australia - Maturation requirements for imported alcoh ol (ID 63678) 
2.370.   The delegation of Brazil  provided the following statement. Brazil continues to follow closely 
Australia's proposal to amend current regulations dealing with alcoholic beverages, and we would 
like to thank Australia for its response in the Com mittee's last meeting and for its engagement in 
bilateral talks. In past 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 
bevera ges 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 whis ky, it encompasses 
tariff line 2208.40.00 (rum and other spirits obtained by distilling fermented sugarcane products), 
under which cachaça is classified in Australia. By granting the same treatment to cachaça and rum, 
the Australian government does not all ow imports of cachaça that are not matured for at least 2 
years in wood. Such a requirement does not relate to any quality standard or sanitary requirement 
applicable to cachaça.  
2.371.   Following a public consultation in late -2019, the Australian Border Force (AB F) further 
explored a potential avenue to amend the Customs Act 1901 (Customs Act) that would enable the 
legitimate importation of certain alcohol products into Australia whilst retaining the maturation 
requirements for brandy, whisky, and rum. According t o a more recent public consultation, the 
Australian government is developing an approach that is looking to retain Australia's existing 
maturation requirement for imported brandy, whisky, and rum, but would establish a list of products 
exempt from this mat uration requirement. The proposed list of exempt products would include 
Cachaça, Pisco and Bourbon. 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 
 
77 The intervention was made by Chair at the beginning of the last day (15 July) to address a timing 
issue.  
78 For previo us statements follow the thread under ID 636 . G/TBT/M/87  
 
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  to avoid any confusion in the Austr alian market or among Australian consumers, we support that 
none of the sugar -cane products imported to Australia (matured or unmatured) that are not 
specifically "rum" should be labeled or marked as "rum". We kindly urge Australia to clarify the 
following  points, which could not be addressed in its previous statements: Could Australia please 
confirm if this new regulation will also establish new labeling requirements for products other than 
rum, brandy and whisky? Could Australia provide timeframes for the  publication of the final text?  
2.372.   In response, the delegation of Australia  provided the following statement. We acknowledge 
Brazil's continuing interest in Australia's review of maturation requirements for imported alcohol and 
provide the following update on  this matter. Australia has concluded its review of the legislative 
framework for the importation of certain unmatured alcohol products under section 105A of the 
Customs Act 1901 (Customs Act). We acknowledge that the review process took longer than 
antici pated due to the impact of the COVID -19 pandemic and the legislative complexities associated 
with this matter. Taking into account stakeholder concerns identified through public consultations in 
2019 and 2020, we are now working with the new Australian Gov ernment to make changes to the 
maturation requirements as necessary and as a priority. The Australian Government will notify the 
Committee of any proposed legislative changes to section 105A of the Customs Act and any other 
changes to alcohol import requir ements, in accordance with Australia's obligation under the TBT 
Agreement, once all necessary Australian Government processes have been finalized regarding 
changes to the maturation requirements.  
2.1.3.42   India – FSSAI's Food Safety and Standards (Food Products Sta ndards and Food 
Additives) Regulations, 2011 and the new implementing veterinary certificate for dairy 
products (ID 63379) 
2.373.   The delegation of the European Union  provided the following statement. The European Union 
would like to refer to its previous statements on this matter. While the European Union fully supports 
the importance of labelling the presence of animal rennet, the European Union considers that the 
new certificate requiring that milk products have not been manufactured using animal rennet is not 
proportionate and not in line with the TBT agreement. Veterinary certificates are to address sanitary 
(human or animal) health issues and 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. 
Therefore, the European Union would ask India to amend the provisions of that veterinary certificate 
and allow for  a label clearly indicating the presence of animal rennet in the cheese and its by -
products, as it was previously the case. This label would allow consumers to make an informed 
choice.  
2.374.   In response, the delegation of India provided the following statement. The provision for non -
animal rennet in cheese manufacture is not newly introduced in FSSAI regulations. This provision 
exists in Food Safety and Standards Regulations (FSSR) notified in 2011 and the erstwhile Prevention 
of Food Adulteration Rules. During a  recent revision of the milk and milk product standards in FSSR, 
these provisions were retained and continue to be a specified requirement. The requirement of a 
veterinary certificate has been recently aligned with FSSR regarding the prohibition on the use  of 
animal rennet. Hence, FSSAI has not introduced any new condition.  
2.1.3.43   Republic of Korea - Revision of Safety Conformation Criteria for Textile Products 
for Infants, G/TBT/N/KOR/678  (ID 65280) 
2.375.   The delegation of the European Union  provided the following statement. The EU would like 
to ask the Republic of Korea to provide contact details of conformity assessment experts from the 
Korean Agency for Technology and Standards (KATS) in order to make progress on resolving this 
issue with the view to having conformity testing, to the specific Korean rules for infant clothing, be 
performed outside Korea by internationally accredited laboratories. Contact details from the EU side 
were provided in March 2022. A meeting took place between the E U delegation in Korea and KATS 
in May 2022. At this meeting, KATS was apparently suggesting an alternative way forward and 
committed to providing further information but, as yet, no information has been received so we 
would appreciate if you could contact KATS in order that we receive this input in a timely manner.  
 
79 For previous statements follow the thread under ID 633 . 
80 For previous statements follow the thread under ID 652 . G/TBT/M/87  
 
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  2.376.   In response, the delegation of the Republic of Korea  provided the following statement. Korea 
would like to thank the EU for its concerns and comments regarding the "Requirements for Textile 
Produ cts for Infants" of Korea, and we would like to take this opportunity to respond to the request, 
which was raised by the EU at this TBT Committee. In May, an informal meeting was held between 
the Korean officials in charge and the EU delegation in Korea fo r a working -level discussion regarding 
the EU's requests to designate a KC testing institution to be in charge of Korean infant textile 
products in the EU and to exchange contact points for experts in relation to this. At this meeting, 
the EU's request for  the designation of a testing institution with regard to infant textile products in 
the EU as a KC testing institution for Korea was discussed. Practically, it would have a limitation 
under the current Korean laws, to designate a testing institution in the  EU as Korea's KC testing 
institution related to infant textile products. Also, at the Korea -EU FTA Goods and Trade Committee 
meeting, in April 2022, Korea requested the EU for the designation of an institution in Korea as an 
Approval Authority that can is sue E -mark for automotive tyre certifications. Korea reiterated this 
matter in May in the informal working -level meeting with the EU delegation in Korea.  
2.377.   In conclusion, both Korea and the EU have requested each other for the designation of a 
testing instit ution within one's own country. In order to address this issue of mutual designation of 
an institution, Korea mentioned in the working -level discussion, in May, that it would be necessary 
to review MRA between Korea and the EU. And the EU, also agreeing wi th this, requested Korea to 
provide MRA -related materials. Discussions surrounding Mutual Recognition Agreement (MRA) 
require the participation of various stakeholders (government officials, testing and certification 
experts, relevant industry, etc.), so t hat continuous consultations between the two parties are 
necessary. For this reason, Korea believes that we are in need of a mechanism through which TBT 
issues between two parties can be discussed formally and efficiently. Therefore, Korea would like to 
propose to the EU to establish the TBT Dialogue or the TBT working -group based on the Korea -EU 
FTA. Through the establishment of such a mechanism, Korea expects that TBT issues between the 
two parties can be discussed/resolved efficiently.  
2.1.3.44   European Union - Commission Delegated Regulation (EU) 2019/945 on 
Unmanned Aircraft Systems and on Third -country Operators of Unmanned Aircraft 
Systems, G/TBT/N/EU/628  (ID 58581) 
2.378.   The delegation of China  provided the following statement. In accordance with the TBT 
Agreement, which requires that "techni cal regulations shall not be more trade -restrictive than 
necessary to fulfill a legitimate objective", it is recommended that the EU could maintain the noise 
limit at 83dBA, the reasons are as follows:  1. The requirements for noise limits are much higher 
than the requirements to protect human health. According to the EU Directive 2003/10/EC "The 
minimum health and safety requirements regarding the exposure of workers to the risks", the 8 -
hour sound exposure levels are: exposure limit values: LEX,8h = 87 dB( A); upper exposure action 
values: LEX,8h 85 dB(A) and lower exposure action values: LEX,8h = 80 dB(A). We have derived 
the conclusion from the formula (provided annex for the derivation process) that: 1) At a sound 
power level of 81dBA, a drone can meet th e arbitrary sound exposure level requirement within 8 
hours when a person only needs to be 0.32m away from it. 2) At a sound power level of 83dBA, a 
drone can meet the arbitrary sound exposure level requirement when 0.4m away from it. 3) If 
calculated base d on a normal flight distance of 3m for recreational drones, the permissible value of 
sound power for drones can even be increased to 100dBA. The above -mentioned derived formulas 
were also carried out in unprotected, regular daily exposure to drone noise. In practical application 
scenarios, category C1 and C2 drones are mostly operated remotely. The control distance between 
humans and drones can be 7 -10km, and there is no situation where a person has to be in close 
proximity to the sound source for a long t ime in order to use it, which has a much lower impact on 
human health.  
2.379.   2. If the noise limit is continually reduced, it will lead to a reduction in the drones' 
performance. Drone noise primarily comes from the rotating propellers. As the requirement of the  
regulation is to sound power levels rather than sound pressure levels in the direction of impact (e.g. 
ground), it is not possible to achieve the limits by changing the directivity of the sound radiation, or 
reducing the noise in a particular direction, e tc., which can only be achieved by reducing the weight 
of the drone or by significantly reducing the rotational speed of the propellers. On the one hand, 
reducing the weight would make drones impossible to carry a larger, more capable camera and 
gimbal, on  the other hand, reducing the rotational speed of the propellers will lead to larger propeller 
 
81 For previous statements follow the thread under ID 585 . G/TBT/M/87  
 
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  size and higher torque, resulting in shorter endurance and an increased risk of propeller injury to 
people in some certain circumstances. To follow Art 2.2 not c reating unnecessary trade barriers to 
trade, China suggests that the EU sets the sound power limits at 83 dBA already fully satisfies the 
necessary requirements for human health protection.  
2.380.   In response, the delegation of the European Union  provided the fol lowing statement. The 
draft Commission Delegated Regulation on unmanned aircraft systems, and on third -country 
operators of unmanned aircraft systems was notified to the WTO on 9 January 2019 under 
G/TBT/N/EU/628 . Commission delegated Regulation (EU) 2019/945 on unmanned aircraft sys tems 
and on third -country operators of unmanned aircraft system and Commission Implementing 
Regulation (EU) 2019/947 on the rules and procedures for the operation of unmanned aircraft were 
published in June 2019. Regardi ng the noise requirement, the EU wou ld like to draw the attention 
of the delegation of China to the fact that those requirements apply to a limited number of products 
(C1 and C2 UAS). The objective of the requirement is not so much to protect the health of the drone 
pilot as to reduce noise pollution for citizens. More detailed answer can be provided after a detailed 
analysis of the Chinese comments.  
2.1.3.45   United Arab Emirates - Requirement of G -mark for every toy (ID 70282) 
2.381.   The delegation of India provided the following statement. India has raised  this STC in the 
two previous TBT meetings and is still waiting for a response from the UAE. India is deeply concerned 
about the UAE's G -Mark requirement for all children's toys exported to the UAE. It can be issued 
only by the agencies authorized by the G CC Standardisation Organisation. 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 pl ace where it can be G -mark certified. The G -mark needs to be obtained for each toy as per the 
extant regulation. This process involves additional procedural requirements; it is also cost -intensive 
and makes the Indian product uncompetitive when placed in t he UAE market. Further, during the 
conformity assessment, the G -mark Notified Bodies (NBs) frequently request physical samples of all 
products in a group, not only the representative item. Despite the latest GSO guidance specifying 
test reports are require d for only 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. As per Article 5.1.2 of the TBT Agreement, Members are obligated to 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 stricter or 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.  
2.382.   Hence the UAE is requested to consider that when the G mark is obtained for each and every 
toy, then the phys ical sampling should not be insisted by the Notified Bodies for all the products in 
the group. Such insistence is trade -restrictive and renders high costs and difficulties. Besides, it is 
also inconsistent with Article 5.1.2 of the TBT Agreement. We urge t he delegation of United Arab 
Emirates to engage constructively on this issue. We are keen to discuss this issue bilaterally as well . 
2.383.   In response, the delegation of the United Arab Emirates  did not make a statement during 
the meeting. A technical statement was circulated following the meeting.83 
2.1.3.46   Colombia – Good manufacturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 69784) 
2.384.   The delegation of the European Union  provided the following statement. I would like to refer 
to our previous statements and the statemen t uploaded in the eAgenda. I would also like to 
encourage Colombia to continue the fruitful cooperation with the EU delegation regarding a possible 
acceptance of Free Sales Certificates issued in the EU member States.   
2.385.   The European Union would like to than k Colombia for its reply of November 2020 to the EU 
written comments and for the extensive bilateral discussions. The European Union notes that Article 
3 of the Decree no 162 published on 16 February 2021 refers to the possibility to present alternatives 
 
82 For previous statements follow the thread under ID 702 . 
83 G/TBT/W/772 . 
84 For previous statements follow the thread under ID 697 . G/TBT/M/87  
 
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  to the Good Manufacturing Practices certificate upon import to 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, which 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 Go od Manufacturing Practices certificate upon import. The European Union 
would, therefore, like to ask Colombia to confirm this interpretation. As the time left for the entry 
into force of these requirements is getting shorter, the European Union is increasi ngly concerned 
about negative impact this measure could have on its exports of wines and spirits, especially from 
SMEs, should not all its Free Sale Certificates be accepted. Therefore, the European Union is prepared 
to continue the bilateral work should t here be any need for additional clarifications.  
2.386.   In response, the delegation of Colombia  provided the following statement. Colombia thanks 
the European Union for working with the relevant health authorities to clarify the concerns raised 
regarding complianc e with Decree No. 162 of 2021, issued by the Ministry of Health and Social 
Welfare. In this regard, we wish to report that the relevant authorities continue to work with the 
European  Union, through the EU Trade Section in Colombia, on issues related to com pliance with 
Decree No. 162 of 2021, particularly in respect of the acceptance of certificates of good 
manufacturing practices, thus responding to the concerns raised relating to the acceptance of 
certificates of free sale (CVL) issued by the competent aut horities of the European Union. As a result, 
the text issued amended Article 22 of Decree No. 1686 of 2012, to ensure equal conditions relating 
to the certificate of good manufacturing practices (GMP) for domestic producers and producers 
located outside th e national territory, and provided the following four alternatives for complying with 
the technical regulation: (a) Certificate of good manufacturing practices (GMP), from the 
manufacturing and/or packaging establishment, issued by the relevant authority o f 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 rele vant 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 
autho rized third party in the country of origin of the product, stating that the alcoholic beverage and 
the producer 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 packaging establishment, issued by the National Food and Drug Surveillance Institute 
(INVIMA).  
2.387.   Thus, in order to comply with the requirement in the case of imported beverages, the Decree 
sets out four feasible options that do not disregard the regulations of the country of origin of the 
parties concerned, meaning that such parties can assess each of the above options and apply one 
of them in order to comply with Colombian regulations. The health authorities have indicat ed that 
certificates of free sale may be included within the scope of paragraph (c), provided that they comply 
with the provisions of that paragraph, namely: (i) they are issued by the relevant authority, by the 
accredited certification body or by the auth orized third party in the country of origin of the product, 
and; (ii) they state that the alcoholic beverage and the producer comply with the technical standards, 
processes or procedures or are subject to monitoring and inspection. In view of the above, an d from 
the information provided by the European Union, a technical and legal analysis of the guidance 
provided by Decree 162 of 2021 was conducted. Based on this analysis, working sessions with 
INVIMA will be held, in order to determine what measures would  be taken to comply with the current 
regulations. We would like to reiterate to the European Union our interest in continuing the joint 
work that has been taking place between our health authorities.  
2.1.3.47   Argentina - Requirement of affidavit along with the prod uct certification from a 
certified body for export of boards derived from wood, G/TBT/N/ARG/342/ Add.6  (ID 
69685) 
2.388.   The delegation of India provided the following statement. India has raised this concern in 
the previous TBT meetings; we thank Argentina for acknowledging the STC and look forward to a 
detailed reply. Argentina has notified the requirement of an affidavit in addition to a produc t 
 
85 For previous statements follow the thread under ID 696 . G/TBT/M/87  
 
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  certification from a certified body for the export of boards derived from wood. We refer to the 
statement made in the previous TBT meeting and request Argentina for a timely resolution.  
2.389.   In response, the delegation of Argentina  provided the following stat ement. By means of 
SCI Resolution No.  240/2019, amended by Resolution No.  428/2021, the Secretariat of Domestic 
Trade approved the Specific Technical Regulation establishing the technical quality and safety 
requirements to be met by coated and uncoated woo d-based fibreboard and particleboard marketed 
in the territory of the Argentine Republic.  The purpose of the measure was to address the problem 
identified with the presence on the market of low -quality boards that pose a risk to human health, 
mainly linked  to high formaldehyde emissions, low mechanical strength and low abrasion resistance, 
without the consumer being able to distinguish between these and other boards at the time of 
purchase.  Consequently, the Secretariat of Domestic Trade considered it appro priate to approve a 
measure to prevent health risks and ensure the safety of users of wood particleboard and wood 
fibreboard, establishing a mandatory regulation that sets out the technical quality and safety 
requirements to be met by wood -based boards mar keted in the territory of the Argentine Republic.  
The regulation sets out essential requirements to ensure human safety and product quality, referring 
to technical standards that establish, among other matters, the maximum permissible limits of 
formaldehyd e that boards may emit or contain, with the aim of protecting the health of the 
population and consumer rights.   
2.390.   With regard to conformity assessment procedures, we reiterate what was previously stated 
about the procedure provided for in SCI Resolution No.  240/2019 and its amendment, SCI Resolution 
No. 428/2021, which establishes three different stages for the implementation of the measure that 
do not overlap, given that the affidavit stage ends once the certification stage takes effect. The 
various require ments at each stage do not imply a duplication of requirements but provide a 
transition period until the full certification stage. This gives operators and the quality system time 
to adapt to it.  Lastly, it bears repeating that the Argentine Focal Point ha s no record of the comment 
submitted by India.  
2.1.3.48   European Union - Withdrawal of the approval of the active substance alpha -
cypermethrin, G/TBT/N/EU/770 , G/TBT/N/EU/908  (ID 69486) 
2.391.   The delegation of Brazil  provided the following statement. Brazil would like to express its 
concerns related to European notification 7 70 regarding the Commission Implementing Regulation 
proposal to withdraw the approval of the active substance alpha -cypermethrin. Alpha -cypermethrin 
is registered in Brazil as an insecticide used against harmful pests that damage a variety of crops, 
includ ing soy, cotton, corn, citrus, watermelon, peanut, coffee, among other products exported to 
the European Union. 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. 
The substance is essential to control greening, a disease affecting citrus orchards 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.  
2.392.   Alpha -cypermethrin is also a n important component to conduct integrated pest 
management, once it may be combined with other insecticides to contribute to increase their useful 
life, ensuring efficient pest control and maintaining the sustainability of crop production. In light of 
the above, Brazil would like to kindly encourage the EU to adopt MRLs for imported products in 
accordance with the limits set under the Codex Alimentarius. Also, we would like to consult if the EU 
may extend the approval of the active substance beyond 31 Octo ber, in order to minimize the impact 
on Brazilian citrus producers. Last, on a related notification submitted last week (G/TBT /N/EU/908) , 
the EU communicated the review of all existing maximum residue levels for Clothianidin and 
Thiamethoxam, on the grounds of (and I quote) "an env ironmental concern of global nature" (end 
of quote). These two active substances are very important as insecticides used against harmful pests 
for a wide variety of crops, like soybeans, coffee, corn, tobacco, sugarcane and fruits. We kindly ask 
the EU to consider extending the 60 days period of consultations and postponing the proposed date 
for adoption of the review so that comments from Members can be taken into account and negative 
implications for agricultural producers worldwide can be mitigated.  
 
86 For previous statements follow the thread under ID 694 . G/TBT/M/87  
 
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  2.393.   The delegation of Paraguay  provided the following statement. We thank Brazil for raising its 
concern in relation to the withdrawal of the approval of the active substance alpha -cypermethin by the 
European Union prior to the potential reduction of its MRLs and request that our support be recorded.  
Paraguay wishes to reiterate the importance of this substance in controlling pests that attack crops 
of great economic importance to the country, such as maize, soybean, sunflower and cotton.  In this 
regard, Paraguay o nce again requests that, during the review of the MRLs for this substance, the 
European Union take into consideration information on pesticides provided by the specialized 
agencies recognized by the WTO, such as the Codex Alimentarius, and reconsider its a pproach and 
base its decisions on conclusive scientific evidence and real risk weightings, in accordance with 
relevant international standards and principles.  
2.394.   In response, the delegation of the European Union  provided the following statement. As 
explained in previous TBT Committees, 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 regards 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 1107/200987 on plant protection products was 
not submitted and the applicant had clearly stated that he will not fulfil his regulatory obligati ons, 
the approval for Alpha -cypermethrin had to be withdrawn according to Article 21(3) of Regulation 
(EC) No 1107/2009. As regards Maximum Residue Levels (MRLs), a review of the whole group of 
cypermethrins is currently ongoing by the European Food Safety  Authority (EFSA). Existing Codex 
maximum residue limits and import tolerances will be considered in this review. EFSA intends to 
finalise the review in the second half of 2022. After that, the EU will consider the outcome and follow 
up on it, if appropria te. If there was a need for a specific measure on MRLs, such a measure would 
be notified to the WTO/SPS Committee. If Brazil and other Members consider it necessary to ensure 
that MRLs for Alpha -cypermethrin on relevant crops that were based on previous an d now obsolete 
EU uses remain or should be newly set at higher/different levels, they may wish to submit an 
application for setting import tolerances according to Article 6 of Regulation (EC) No 396/200588 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin. The EU would 
like to invite Brazil to contact the relevant authorities in Belgium, 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.  
2.1.3.49   Indonesia - Government Regulation 28 of 2021 – Implementing Regulation (for 
the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act" (ID 
72489) 
2.395.   The de legation of the European Union  provided the following statement. The EU refers to 
previous statements on this matter and also to the statement uploaded in eAgenda. It is quite a 
complex legislation which affects several sectors. We would like to thank the delegation of Indonesia 
for the good cooperation. We understand that there are some improvements in implementation so 
we hope that we continue in this direction.  
2.396.   The European Union is seriously concerned by Government Regulation No.28 of 2021 and 
new requ irements for Indonesian National Standard (SNI) certification. This Regulation is one of the 
implementing regulations of the Omnibus Law on Job Creation (Law 11/2020) passed last year. 
Government Regulation 28/2021 aims to increase the competitiveness of I ndonesia's national 
industry and mainly outlines measure related to raw materials. It also introduces new requirements 
with regard to product certification bodies (Lspros). We understand that the new requirements affect 
in principle all products subject to  SNI certification and it is very complex to export to Indonesia. 
Certain sectors appear to be particularly concerned.  
 
87 Regulation (EC) No 1107/2009 of the European Parliament and of the Coun cil of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives  79/117/EEC 
and 91/414/EEC. OJ L 309 24.11.2009, p. 1.  
88 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 2 3 February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1.  
89 For previous statements follow the thread under ID 724 . G/TBT/M/87  
 
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  2.397.   With regard to the toys sector, articles 38 and 39 create significant challenges. Article 38 
prohibits certification bodies (Lspros) from  using third -party testing facilities. Article 39 stipulates 
that product certification bodies (Lspro's) be Indonesian entities, employ Indonesian citizens, 
residents of Indonesia to assess product compliance to Indonesian National Standards. Regulatory 
bodies are now giving this article an overly strict literal interpretation as requiring that every step of 
the SNI certification be conducted by Indonesian nationals residing in Indonesia, etc. We understand 
this is both required for scheme 1 (batch testing and pre -shipment inspection) and scheme 5 (factory 
certification). This new approach appears to be implemented despite of no ministerial implementing 
regulation, which is normally required in the Indonesian regulatory process to implement a 
Government Regu lation. In terms of impact, this means that for batch testing and pre -shipment 
inspection, samples need to be taken by an employee/Indonesian resident of certification bodies. 
Due to travel restrictions related to COVID, it was and it is very difficult for  certification bodies 
(Lspros) to send personnel overseas to sample products or to conduct factory audits. As a result, all 
certification bodies have either stopped overseas sampling or stopped overseas certification 
altogether.  
2.398.   In addition, even when inte rnational travel would be easier, the new requirements will still 
add significant costs and delays. The tire industry is also facing major problems. According to our 
information Indonesia is applying a mandatory certification system for certain spare parts  (original 
and non -original) including tires, safety glazing, rims, primary -batteries and audio/video -
components. This implies the audit of the plant where the spare parts are produced (in accordance 
with ISO 9001) as well as an analysis of the products co nducted by Indonesian test institute. This is 
followed by scheduled conformity of production audits. Currently the Indonesian test institute has 
suspended both the audit of the plants for new certifications, as well as the conformity assessment 
inspections . The result is that products requiring a new certifications cannot be imported into 
Indonesia, and those products which already have a certification will be also banned from Indonesia 
when their respective certifications expire. The European Union would l ike to understand what 
measures Indonesia is putting in place to ensure that EU spare parts can be smoothly imported into 
Indonesia.  
2.399.   In addition, we would like to stress that EU products certified in accordance with United 
Nations (UN) regulations under th e 1958 Agreement have similar or higher levels of road safety and 
environmental protection performance than those certified in accordance with the Indonesian 
regulations. Therefore, the European Union would like to invite Indonesia to accept the EU spare 
parts bearing a UN marking or being accompanied by an UN certificate. The European Union would 
also like to propose extending the validity of issued Indonesian certificates until Indonesia can 
resume the conformity of production activities. In addition, Ind onesia is encouraged to consider 
allowing the import of EU original parts, given that original parts have already proven their 
performance on vehicles in use in Indonesia. The EU notes that the non -implementation of the 
recommendations above could result i n the exclusion from the Indonesian market of products that 
are perfectly safe and exceed the Indonesian requirements as regards the safety. Finally, we would 
like to highlight that new SNI requirements have negative impact also on EU machinery industry. T o 
conclude, the European Union invites Indonesia to notify to the WTO the Government Regulation 
28/2021 before going ahead with its implementation; and to provide adequate time for consultation 
with the industry considering the sweeping changes at issue. W e remain available to discuss the 
issue also bilaterally.  
2.400.   The delegation of the United States  provided the following statement. The United States 
continues to have serious concerns with the Government of Indonesia Regulation No. 28 of 2021, 
which is the Im plementing Regulation (for the Manufacturing/Industry Sector) to Law No. 11 of 2020 
of the "Job Creation Act " (GR28/2021), particularly when this measure is already disrupting trade 
between our countries. US industry is reporting that, in the absence of im plementing regulations 
from the Ministry of Industry, many conformity assessment bodies have halted certification for 
foreign products, resulting in the halt of exports requiring Indonesian national standards (SNI) 
testing per shipment. We understand these  implementing regulations are still undergoing domestic 
processes and we urge Indonesia to fulfill its transparency obligations and notify these regulations 
in draft form to this Committee prior to finalization. We strongly request Indonesia to ensure that  
all domestic conformity assessment bodies are continuing foreign product certification per previous 
guidance. We again ask Indonesia to provide a justification for the new requirement that conformity 
assessment testing to be conducted by Indonesian citize ns domiciled in Indonesia. How do these 
requirements relate to the ability to perform conformity assessment?  G/TBT/M/87  
 
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  2.401.   We are concerned that requiring onsite inspections and collection of product samples solely 
by Indonesian nationals domiciled in Indonesia will eff ectively halt imports into Indonesia, and 
already appears to be doing so. Why is Indonesia not allowing remote factory inspections, given 
travel restrictions and disruptions caused by the ongoing global pandemic that may prevent onsite 
inspections? Indones ia recently noted to us that they will only accept foreign conformity assessment 
from labs that have been selected by the Ministry of Industry in Member countries that have signed 
a mutual recognition agreement. Can Indonesia please elaborate on the necess ity and contents of 
these proposed MRAs? Will further guidance about these requirements be included in the 
implementing regulations for GR28/2021? We again seek clarification on whether Article 38 requires 
that conformity assessment bodies must also operat e their own testing laboratories for all products 
required to be certified to SNIs. We again encourage Indonesia to immediately communicate to 
Indonesian conformity assessment bodies that certification of foreign product shipments can, and 
should, continue  while MOI prepares the implementing regulations.  
2.402.   The delegation of Canada  provided the following statement. Canada joins other Members to 
raise its concerns with Indonesia's Government Regulation 28 of 2021 – Implementing Regulation 
(for the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act", which was 
published on February 2021 as part of an implementing regulation to the Omnibus Law on Job 
Creation. Canada understands that Government Regulation 28/2021 introduces new requirements 
with regard to product certification bodies (Lspros) and SNI certificatio n. More specifically, Article 
39 (e) states that "Certification agencies as referred by Article 38 verse (1) are required to … deploy 
competent personnel who is an Indonesian national, domiciled in Indonesia, is fluent in the 
Indonesian language, understan ds regulations, and has been registered by the Minister ". Could 
Indonesia please confirm whether this means that every step of the SNI certification must be 
conducted by Indonesian nationals and that they must be domiciled in Indonesia? In addition, Articl e 
38 (4) states that "The appointed certification agencies as referred by verse (3a) must … have an 
accredited testing laboratory based on SNI ISO/IEC 17025 or an accredited inspection lab based on 
SNI ISO/IEC 17020 ". 
2.403.   Could Indonesia please confirm whether  this means that the Regulation prohibits Lspros 
from using third -party testing facilities and requires that every Lspro owns and operates a testing 
lab for all products – across all industries - they certify. Could Indonesia also confirm whether those 
requirements apply to all products regulated under SNI, which we understand to be over 100 
products across all industries? At the last TBT Committee meeting, Indonesia indicated that SNI 
certifications are conducted through factory inspection and samples are taken on -site by authorized 
personnel. Indonesia also stated that it accepts testing result from accredited foreign testing 
laboratories under the mutual recognition arrangement framework and availability of technical 
regulation agreement between Indonesia  and a partner country. Canada is unclear how inspection 
of factories or product sampling abroad is necessary to ensure that products comply with Indonesian 
safety requirements. If the purpose of the inspection is in fact product testing, what would be 
Indonesia's rationale for not accepting ILAC accredited foreign testing laboratories without a mutual 
recognition arrangement framework in place? The MRAs Indonesia proposes would not be a solution 
for Canada as, first, we do not have similar regulatory requi rements, and second, MRAs would not 
address the full extent of Canada's concerns given that several stakeholders have their production 
located outside Canada, where Canada is not in a position to facilitate MRA discussions.  
2.404.   The requirement for on -site fact ory inspection, inspection by an Indonesia national, and 
testing by a person domiciled in Indonesia are all unnecessary barriers to trade. In addition, failing 
to provide alternatives is inconsistent with international product safety practices. Canada kind ly asks 
that Indonesia pause the implementation of this measure, notify it to this Committee, provide a 
minimum 60 -day comment period for members to comment, and take those comments into 
consideration before finalising the measure. Canada strongly encourag es Indonesia to review the 
interpretation of Government Regulation 28/2021 and provide more flexibility regarding the 
requirement for Indonesian nationals, and residents of Indonesia to perform product sampling, 
factory audits, and testing. Canada also kin dly requests Indonesia accept test results from ILAC 
accredited foreign testing laboratories, and to consider developing clear guidance for industry.  
2.405.   In response, the delegation of Indonesia  provided the following statement. Indonesia thanks 
the United Sta tes of America, the European Union, and Canada for its continuous interest on 
Government Regulation 28 Year 2021. Indonesia would like to refer to its last statement in TBT 
Meeting on March 2022, and in our bilateral discussion with the US and EU. Certific ation process for 
technical regulations based on SNI in the industrial sector is carried out in accordance with the G/TBT/M/87  
 
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  provisions stated on the related Minister Regulation. All provisions regarding standard and 
conformity assessment scheme apply equally for b oth domestic and foreign manufacturers. 
Indonesia accepts testing results from accredited foreign testing laboratories under the mutual 
recognition arrangement framework and availability of technical regulation agreement between 
Indonesia and its country p artner.  
2.1.3.50   India - Chemical Fibers and Yarns: PSY, IDY, FDY, POY, PSF, and SMF for use in 
Cement -Based Matrix (Quality Control) Orders, 2020, G/TBT/N/IND/185 , 
G/TBT/N/IND/188 , G/TBT/N/IND/189 , G/TBT/N/IND/190 , G/TBT/N/IND/192 , 
G/TBT/N/IND/194  (ID 71790) 
2.406.   The delegation of the Republic of Korea  provided the following statement. Regarding India's 
six Quality Control Orders (QCOs) for Chemical Fibers and Yarns (PSY,  IDY, FDY, POY, PSF, and 
SMF91) notified to the WTO on January 2021 as G/TBT/N/IND/185 , G/TBT/N/IND/188 , 
G/TBT/N/IND/189 , G/TBT/N/IND/190 , G/TBT/N/IND/192  and G/TBT/N/IND/194 , Korea submitted 
comments three times in Augu st and November 2021, and March 2022, concerning the enforcement 
dates and revision of regulation. In response, the Indian government provided an additional grace 
period twice, firstly until April 2022 and secondly until October 2022, partially resolving t he 
difficulties of Korean companies. Korea fully appreciates the Indian government for its kindest 
efforts. We respect the efforts of India to introduce Chemical Fiber QCOs for the health and safety 
of the Indian people. Furthermore, Korean companies are m aking their best efforts to faithfully 
comply with the regulations of India. However, we would like to deliver requests as Korean 
companies still have unresolved technical difficulties regarding the six QCOs.  
2.407.   Firstly, the notified BIS regulations are consi dered excessive compared to international 
practices. Generally in other countries, the governments do not operate certification schemes for 
the items under the scope.92 And in privately operated certification system (not governmental 
certification scheme),  certificates are issued after the product testing is performed only once either 
by a designated laboratory or during an on -site factory audit. However, in the case of India, not only 
does the government implement compulsory certification schemes for these  items, but also its 
regulations require products to be tested twice, during a factory audit and by a local BIS -designated 
laboratory. The duplicated test requirement causes an undue burden on the relevant industry. 
Therefore, we request that India streaml ine the certification process so that chemical fibers and 
yarns can be certified with a single test conducted by a BIS -designated organization, bypassing the 
test during an on -site factory audit.  
2.408.   Secondly, the information on the attachment location for the  ISI Mark is not publicly 
available. If it is required to attach the mark directly to the product, it is practically difficult to comply 
with the regulation due to the nature of the yarn product. Therefore, we request that India provide 
information on the method of mark attachment. In case that the mark is to be attached to the 
product, we request that India mitigate the certification requirements in a reasonable way for 
manufacturers to accept such as recognizing BIS certification numbers declared in shipp ing 
documents as an alternative method93 for the ISI mark attached to the product. Your reply on this 
matter would be deeply appreciated.  
2.409.   The delegation of the European Union  provided the following statement. The European Union 
would like express its suppo rt to this trade concern raised by Korea. The notified measures require 
products to be tested twice, including local audits and designated laboratory tests. There is also an 
additional burden to the EU industry related to registration, bank -guarantee, and certification. The 
control by the Bureau of Indian Standards (BIS) is seen as disproportionate as the products do not 
present risk to health and safety, and they are subject to a detailed quality control in the EU before 
being exported. Furthermore, the no tified measures deviate from international standards.  
 
90 For previous statements follow the thread under ID 717 . 
91 PSY: 100 Percent Polyester Spun Grey and White Yarn; IDY: Polyester Industrial Yarn; FDY: Polyester 
Continuous Filament Fully Drawn Yarn; POY: Polyester Partially Oriented Yarn; PSF: Polyester Staple Fibres; 
SMF: Synthetic Micro -Fibres for use in Cement Based Matrix.  
92 Korea (KC certification) and the United States (CPSIA regulation) require compulsory certification only 
for children's textile products or skin -conta ct textile products such as clothing. Other items such as yarns are 
managed with voluntary certification.  
93 Currently, Oeko -Tex, GRS, etc. include copies of their certificate in shipping documents or send the 
copies to customers separately.  G/TBT/M/87  
 
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  2.410.   In response, the delegation of India provided the following statement. The product 
certification schemes operated by BIS are governed by the BIS (Conformity Assessment) 
Regulations, 2018 notified by the  Central Government. The QCOs issued for PSY, IDY, FDY, POY, 
PSF mandate a licence from BIS under scheme -I of the said regulations as per the respective Indian 
Standard prescribed in the QCOs. The requirement of ISI marking on the product/packaging is a 
statutory requirement under the aforementioned regulations and is equally applicable to both foreign 
and domestic manufacturers. Further, through the ISI mark only the end user / consumer is able to 
identify that the product is certified and conforms to rele vant standard. The detailed guidelines 
including Indian Standards and Product Manuals for certification of PSY, IDY, FDY, POY, PSF are 
available on BIS website.94 The scheme of inspection and testing contained in the product manual 
for each product, availa ble on BIS website, contains the manner of marking of Standard Mark for 
the respective products.  
2.1.3.51   Japan - Inspection system for sports goods and toys and non -acceptance of test 
reports from Indian test houses (ID 74795) 
2.411.   The delegation of India provided the following statement. India had raised this concern in 
the previous meeting of TBT. The details of the issue were provided in that statement. We would 
like to reiterate the questions raised in the previous Committee meetings. We remain concerned 
with the ap plication of WTO -plus private standards, which seem excessive and not in conformance 
with the Good Regulatory Practices as understood in the ambit of TBT. We hope to get an early 
resolution from Japan on this issue dropping trade restrictive practices.  
2.412.   In response, the delegation of Japan  provided the following statement. The Toy Safety 
Standard (ST standard) is not a mandatory technical regulation. The ST standard is established by 
the Japan Toy Association (JTA) itself as a voluntary standard, thus any to ys to be imported and 
distributed in Japan don't have to conform to the ST standard. Japan has already informed India 
that the ST standard is not a technical regulation, and we would like to know further about the 
details of India's concern. Regarding the Food Sanitation Act, standards are set only for toys for 
infants, among the goods India has mentioned. The quarantine stations in Japan check the safety 
of toys for infants and provide guidance for testing as necessary. The quarantine stations in Japan 
accept certificate of analysis from Foreign Official Laboratories as test results to determine the 
conformity to the standards for toys for infants. The Ministry of Health, Labour and Welfare registers 
testing laboratories for which the government of the expo rting country recognizes a certain level of 
inspection ability, and puts those laboratories on the list of Foreign Official Laboratories upon request 
from the government of the exporting country. As previously communicated, the testing laboratories 
in Indi a are registered on that list, and the list is published on the website of the Ministry of Health, 
Labor and Welfare.96 Lastly Japan always welcomes bilateral talk with India on this matter.  
2.1.3.52   United Kingdom - EC marking certificate for export of home textil e items (ID 
74097) 
2.413.   The delegation of India provided the following statement. India had raised this concern in 
the previous meeting of TBT. The details of the issue were provided in that statement. We would 
like to reiterate the questions raised in the prev ious Committee meetings. We also remain bilaterally 
engaged with the United Kingdom and will also appreciate any update on this trade concern.  
2.414.   In response, the delegation of the United Kingdom  provided the following statement. The 
United Kingdom welcomes I ndia's continued interest in our Personal Protective Equipment 
requirements and the certification requirements with respect to two textile items (Oven Gloves and 
Pot Holders). We would like to draw attention to our response from 20 June, outlining that Reg ulation 
2016/425 already states that products which are clearly within the same product family, varying 
only in regard to certain characteristics and which do not impact on the essential health and safety 
requirements of the regulation, can reasonably be c ertified under a common certificate. Where minor 
changes are made after the original certification is issued, it would usually be acceptable for the 
manufacturer to apply for the original certification to be varied, rather than a complete, new 
 
94 www.bis.gov.in   
95 For previous statements follow the thread under ID 747 . 
96 
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/index_00019.html   
97 For previous statements follow the thread under ID 740 . G/TBT/M/87  
 
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  certificatio n being required. Where changes are made to the product, any differences would need to 
be considered in terms of whether they affect the conformity of the product being considered. 
Differences impacting the conformity of a product could include, for instan ce, if a dye used to change 
a product's colour was more flammable or contained harmful toxins. This would be a change which 
impacts the conformity of the individual product. Where changes do not affect compliance, it would 
be possible to incorporate broadl y similar products into a family certification of one or more 
certificates with reduced testing. We also note that the Regulation, as it applies in Great Britain, is 
unchanged in substance from Regulation (EU) 2016/425 on Personal Protective Equipment, oth er 
than to make it work for the Great Britain market. Therefore, the essential health and safety 
requirements remain unchanged, as do the arrangements for conformity assessment, and marking 
(but with UKCA as opposed to CE marking). The essential health and  safety requirements that must 
be met for certification are set out in Annex II Regulation 2016/425. We remain available for further 
bilateral discussions with India to discuss our regulatory approach.  
2.1.3.53   India - Plastic Waste Management (Amendment) Rules, 20 21 and 2022 (ID 
71998) 
2.415.   The delegation of the United States  provided the following statement. On 16 February 2022, 
India's Ministry of Environment, Forest and Climate Change published in the Gazette of India, the 
Plastic Waste Management (Amendment) Rules, 2022 (PWM Amendment Rules), which stated that 
the measure would come into force with immediate effect. India has not yet notified this measure 
to the WTO TBT Committee. We understand that the PWM Amendment Rules introduce guidelines 
towards a framework for Extended Producer Responsibility (EPR) on plastic waste m anagement. 
These guidelines outline targets for EPR volumes, reuse, recycling, end -of-life disposal, and 
mandatory recycled content (collectively, the EPR targets) for producers, importers, and brand 
owners of plastic packaging. Can India please provide mo re information on how it arrived at the EPR 
targets? According to US industry stakeholders, it will be difficult, if not impossible, to meet many 
of the EPR targets given the timelines provided. Has India conducted a feasibility study on the EPR 
targets, a nd if so, will India share this study and any supporting data? We further understand that 
subsequent guidance published by MoEFCC indicates that the regulation went into effect 1 July 2022. 
While we support India's objective to mitigate pollution caused by  plastic waste, we have concerns 
as to the implementation of this measure given the lack of notification and formal input from 
stakeholders and WTO Members. For example, how does India intend to address the limited 
availability of recycled material needed to meet its mandatory recycled content targets, particularly 
given the worldwide shortage of suitable recycled plastics?  
2.416.   Further, we would appreciate more information regarding existing approved recyclers and 
recycling collection systems in India. Has Indi a conducted an assessment of its domestic capacity to 
collect and process materials in a way that supports its goals? We are also aware that US 
stakeholders have requested further clarification on some of the terms, provisions, and 
categorizations in the P WM Amendment Rules in order to effectively comply with the measure. For 
example, stakeholders have noted the need for clarification on: (1) reporting obligations of impacted 
sectors and the corresponding process administered by the Ministry of Environment,  Forest and 
Climate Change; (2) the EPR fee calculation, especially in cases in which a company is not able to 
take back or collect the retail packaging; and (3) how producers, importers, and brand -owners can 
meet their EPR obligations pursuant to section 8.3 by purchasing surplus EPR certificates from other 
producers, importers, and brand owners of the same category. There also remains uncertainty 
regarding how certain packaging is classified in the four categories listed in section 5 of the measure. 
For e xample, what category (I, II, III, or IV) would packaging such as blister packs and 
shrink/transport wrap film fall under? Section 17 of the PWM Amendment Rules appears to be a 
state-level monitoring and reporting mechanism to fulfill obligations establish ed in the EPR. Can 
India provide information on how state -level Central Pollution Control Boards fulfil this requirement? 
Given the significant impact that this measure will have on trade, we reiterate our May 2022 Enquiry 
Point request to notify this meas ure to the WTO TBT Committee; provide a public comment period 
of at least 60 days; take submitted comments into account prior to finalizing and implementing the 
measure; and to provide a reasonable transition period for industry to comply. These steps will  allow 
further engagement with interested stakeholders and provide time for industry to obtain clarity 
regarding provisions, definitions, and classifications to ensure timely compliance with the obligations 
outlined in the PWM Amendment Rules.  
 
98 For previous statements follow the thread under ID 719 . G/TBT/M/87  
 
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  2.417.   In response,  the delegation of India provided the following statement. The Plastic Waste 
Management Rules, 2016, provides the statutory framework for plastic waste management in India. 
Rule 4 of the Plastic Waste Management Rules, 2016, provide for minimum thickness r equirement 
for plastic carry bags and plastic sheets used in packaging and Rule 9 casts Extended Producer 
Responsibility on Producers, Importers and Brand Owners for environmentally sound management 
of Plastic packaging introduced in the market along with the products. The marking and labelling 
requirement on plastic packaging under Plastic Waste Management Amendment Rules, 2021, is not 
discriminatory and is not a barrier to international trade. The requirements are applicable in a 
uniform manner to domesti c and international companies. Such marking and labelling requirement 
have also been put by other countries / regional groupings as well.  
2.1.3.54   European Union - Hazard -based approach to plant protection products and 
setting of import tolerances, G/SPS/N/EU/166 , G/SPS/N/EU/166/Add.1 , 
G/SPS/N/EU/263 , G/TBT/N/EU/383 , G/TBT/N/EU/383/Add.1 , G/TBT/N/EU/384 , 
G/TBT/N/EU/384/Add.1 , G/TBT/N/EU/495  (ID 39399) 
2.418.   The delega tion of Australia  provided the following statement. Australia would like to thank 
the EU for its response to Australia's and other Members' concerns raised during the previous 
meeting. Australia would also like to thank the EU for notifying Members via G/TBT/N/EU/908  on 
6 July 2022 o n MRLs for clothianidin and thiamethoxam. Australia understands that the EU is 
considering lowering existing MRLs for pesticides no longer approved in its jurisdiction due to 
environmental concerns - such as some neonicotinoid insecticides – to the default  value and refusing 
new requests for import tolerances for these products. By applying EU environmental standards to 
imported agricultural products, this measure aims to support the EU's ambition to improve 
environmental objectives globally. While the EU's  ambition is commendable, Australia only supports 
lowering MRLs to default value where a food safety risk has been identified for consumers. Taking 
into account environmental concerns of a global nature in setting import MRLs, in addition to 
consumer dieta ry aspects, introduces arbitrary criteria that are incompatible with current 
international practice. This approach assumes the EU is better placed to assess the environmental 
impacts of active substances in third countries than the chemical regulators of t hose countries.  
2.419.   Furthermore, this approach fails to recognize the efforts of international scientific panels and 
standard setting bodies - such as the Joint FAO/WHO Meeting on Pesticide Residues and the Codex 
Alimentarius - in establishing safe and harmoni zed levels of pesticide residues in agricultural 
products. 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 profita bility while looking after Australia's unique environment. To avoid trade disruption, it is 
imperative that the EU continues to comply with its obligations under the TBT Agreement when 
setting MRLs and considering requests for import tolerances. Australia once again 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 dietary 
risks. Departing from th is approach will result in significant trade disruptions. We remain available 
to discuss our approach to pesticide regulation with the EU and look forward to continued, 
constructive engagement on this issue.  
2.420.   The delegation of Japan  provided the following s tatement. Japan echoes the concerns of 
other Members . Japan considers EU's any plan to lower the MRLs for the neonicotinoid pesticides, 
clothianidin and thiamethoxam, should be made in a manner consistent with the SPS Agreement 
which request to adopt SPS m easures based on scientific principles and appropriate risk assessment 
and in a manner not more trade -restrictive than required to achieve an appropriate level of 
protection. Japan also emphasizes that it is important to respect each Member's right to set its own 
regulations for environmental protection, by reflecting each Member's unique environment 
conditions. Accordingly, in case the proposal is aimed to protect the environment, Japan considers 
that it is important to at least harmonize such measures wit h the international standards which other 
Members agree on. Lastly, Japan would request the EU to notify the draft of new regulations in an 
early stage so that other Members be made aware of them. Japan also requests the EU to provide 
other Members ample o pportunity to comment on the new regulations prior to the introduction.  
2.421.   The delegation of Costa Rica  provided the following statement.  As on previous occasions, 
Costa  Rica reiterates its support for the trade concern raised by Australia, Brazil, Canada and  Japan. 
 
99 For previous statements follow the thread under ID 393 . G/TBT/M/87  
 
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  Costa Rica is concerned about the hazard -based approach adopted by the European Union given 
that, under the obligations of the multilateral system, all technical requirements must be based on 
the relevant international reference standard or a risk assessment providing the scientific evidence 
to support the measure. Costa Rica reiterates its request to the European Union to ensure that the 
implementation of its regulations is based on the use of risk assessments through the application of 
criteria su pported by sufficient scientific evidence, in line with the commitments established in the 
TBT Agreement.  
2.422.   The delegation of Paraguay  provided the following statement. Paraguay reiterates its position 
and refers to its previous statements by stressing the i mportance of adopting a scientific approach 
to the regulation of phytosanitary products based on the risk and not just on the hazard arising from 
the intrinsic properties of a chemical. In this regard, Paraguay once again requests the European 
Union to tak e into consideration information on pesticides provided by the specialized agencies 
recognized by the WTO, such as the Codex Alimentarius; reconsider its approach and base its 
decisions on conclusive scientific evidence and real risk weightings, in accorda nce with relevant 
international standards and principles; ensure import tolerances; and, where necessary, provide 
adequate transitional periods. In addition to the systemic concern, my delegation associates itself 
with the comments of other Members regardi ng recent notification G/TBT /N/EU/908  of 6 July 2022, 
which aims to impose European environmental standards on third countries without taking into 
account the principle of common but differentiated responsibilities, the different climates and 
production systems or the enormous financ ial support that European producers receive to comply 
with these standards. Such an approach also presumes that other Members are not capable of setting 
their own environmental standards.  
2.423.   It is surprising that the EU is submitting this notification when on ly at the most recent 
meeting of this Committee, it refused to discuss maximum residue limits as it considered that the 
concerns about them and any details of their implementation should be discussed in the SPS 
Committee and not in the TBT Committee. It is  also paradoxical that, for several of the substances 
that are banned in the EU and for which import tolerances will not be granted, EU Member States 
have regularly issued and continue to issue emergency authorizations to keep on using them, citing 
the lac k of effective alternatives, despite the potential harm to pollinators pointed out by the EU 
itself. We hope that the EU can provide clarity on the consistency between policymaking and 
implementation within the EU itself as soon as possible. In 2022 to dat e and 2021 alone, 10 
emergency authorizations were issued for the substance clothianidin (Romania, Czech Republic, 
Belgium, Finland, Spain and Austria) and 31 were issued for the substance thiamethoxam by almost 
half of EU Members (Czech Republic, Spain, R omania, Slovakia, Lithuania, Finland, Croatia, France, 
Austria, Hungary, Poland, Denmark and Germany).  
2.424.   We would like to point out that, although EFSA carries out assessments of the emergency 
authorizations granted by EU member States, as the EU rightly poi nts out in document 
G/SPS/GE N/2038 , we have found that, in cases where an emergency authorization is deemed to be 
unjustified, there appear to be no consequences for the Member State. Let me illustrate with an 
example. In May 2018, EFSA published its assessment of six emergency autho rizations granted by 
Romania for the substances clothianidin, thiamethoxham and imidacloprid to treat maize and 
sunflower crops against the pests Tanymecus dilaticollis  and Agriotes spp . EFSA found in its analysis 
that three of these emergency authorizatio ns, including the one to combat Tanymecus dilaticollis  in 
maize, were not justified. Since then, Chair, according to the EU's own database, Romania has 
granted eight emergency authorizations for the substance thiamethoxham and a further four for the 
substa nce chlothianidin, with the most recent having been issued on 25 January this year to combat 
– would you believe it – the same pests, Tanymecus dilaticollis  and Agriotes spp. , in the same crops, 
namely maize and sunflower, which EFSA had found to be unjust ified. We are wondering how a 
Member State can continue to grant emergency authorizations four years after EFSA determined 
that an identical authorization was not justified. We also wonder whether the pollinator problem, 
which is a global concern, accordin g to the European Union, and is the reason why it has indicated 
that it will not grant import tolerances, is not a concern in Romania, or how Romania could be 
excluded from the EU's global objectives. We would also like to point out that Romania is a major  
exporter of honey and the main honey producer in the European Union. Honey produced by the very 
bees that the ban on neonicotinoids is intended to protect. Therefore, we reiterate our query as to 
whether emergency authorizations will continue to be issued  for these substances for which the EU 
has said that it will not grant import tolerances. In conclusion, allow me to call for reflection on the 
impact that this type of measure has on European producers who, as we can see, are demonstrating 
against it in v arious countries of the European Union and feel that their interests are not being G/TBT/M/87  
 
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  served. How much worse is this for Paraguayan producers who, under market conditions, must meet 
the same requirements to access the market of one of the main importers of fo odstuffs?  
2.425.   The delegation 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 principl es, taking all available data into 
consideration. Serious evaluations must be able to separate chemicals that have the potential to 
cause harm due to their endocrine mode of action from those substances that do not pose a threat 
to human health. A solid ri sk analysis, consistent with Codex guidelines, is important to ensure 
transparency and predictability in the regulatory processes regarding plant protection products and 
MRLs. Brazil believes that the European approach to limit the use of pesticides is mor e trade -
restrictive than necessary to fulfill its legitimate objectives under the TBT Agreement. It also 
disregards risk analyses in the setting of regulatory measures that may have a serious impact on 
trade.  
2.426.   The delegation 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 European 
Union's (EU) hazard -based regulation for active substances in plant protection products and th e 
setting of import tolerances. Recognizing different growing conditions in different regions, Canada 
does not insist on any one production method over another and we share the objective of ensuring 
that pesticides are used optimally and only as necessary.  In order to ensure plant health and minimal 
waste, farmers need to have access to a wide range of effective and affordable plant protection 
mechanisms, including both chemical and biological options. We have an effective regulatory regime 
in place to moni tor the safe use of chemical solutions when needed, including clear labelling 
requirements. Using integrated pest management approaches, we support farmers in their own 
assessment of what is needed according to growing conditions, market demand and other f actors. 
Rigorous regulatory requirements exist, including scientific assessments and monitoring programs, 
to ensure the health and safety of consumers where pesticide residues can be a factor, as well the 
health of the environment.  
2.427.   We encourage the EU to t ake an approach which does not unnecessarily limit the availability 
of crop protection tools for growers. Regulatory decisions based on assessments of both hazards 
and risks for all active substances are the best means to ensure consumer safety while suppo rting 
food security and reduced waste. This is ever more important in light of current international supply 
chain disruptions and food security concerns resulting from the Russian invasion of Ukraine, which 
threatens farmers' incomes and the wellbeing of p opulations, particularly in developing and least -
developed countries. The EU has stated that it will be changing how requests for import tolerances 
are established in the context of their current policy objectives, including the hazard -based cut off 
criter ia and other (unspecified) considerations. Canadian growers and exporters have yet to be 
convinced of the real -world feasibility, commercial viability and compliance with international 
obligations of the EU's proposed approach for setting import tolerances  when a plant protection 
product has met the hazard -based "cut-off" criteria. Additionally, the EU has indicated that it intends 
to consider environmental factors in the establishment of maximum residue limits, which would likely 
apply to import tolerances  as well. Canada would appreciate further information on this approach, 
including on who will determine what environmental factors will be considered and how these will 
be scientifically justified in the dietary risk assessment.  
2.428.   Finally, Canada once again requests that the EU consider maintaining MRLs for substances 
that do not pose unacceptable dietary risks and import tolerances be authorized based on dietary 
risk alone. We recognize that a dietary risk assessment as part of the re -authorization process w ould 
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 trad e barriers are minimized and that 
measures are consistent with international trade obligations.  
2.429.   The delegation of Chile provided the following statement. The delegation of Chile thanks 
Australia and the other Members who requested the inclusion of this spe cific trade concern on the 
Committee's agenda. Chile reiterates its position from previous meetings about the importance of 
adopting a scientific and risk -based approach to regulating plant protection products rather than 
considering only the hazard of an agrochemical.  G/TBT/M/87  
 
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  2.430.   The delegation of Colombia  provided the following statement. Colombia once again shares 
the concern raised regarding the approach taken by the EU for identifying and prohibiting the 
marketing of plant protection substances, as well as regardi ng the announcements to reduce MRLs 
to the minimum level of detection for several substances. As we have stated in this and previous 
meetings of this Committee, we reiterate the need for and importance of using risk analysis as a 
methodological tool for de cision -making under the components of assessment, management and 
communication. Under the EU's approach, risk assessment becomes less relevant, as it bases its 
decisions to accept or allow the use of substances on a hazard -based approach, disregarding 
conditions of use and risk scenarios that allow scientifically based decisions to be taken. In light of 
the above, Colombia considers that the EU proposal must take into account scientific evidence, 
production processes and methods, the international recommend ations of the Codex  Alimentarius, 
and the relevant ecological and environmental conditions in countries that could be affected by the 
implementation of the measure, in order to avoid creating an unnecessary technical barrier to trade.  
2.431.   In this connection, w e refer to the recent notification G/TBT/N/EU/908  revising and lowering 
the MRLs for clothianidin and thiamethoxam, following the previous non -renewal of the marketing 
approval for these substances and the expiry of the grace periods. This case is of particular concern, 
not only beca use of the repeated use of the hazard approach to make decisions on plant protection 
substances, but also because of the use of environmental impact criteria to adopt technical 
regulations, without relying on scientific evidence on the human health implica tions. This rule also 
disregards the Codex standards on this substance and adopts a regulation on the EFSA opinion, 
under which no information from third -party stakeholders is taken into consideration. Equally 
worrying is the unilateral application of the European Union's environmental and health standards 
to imported agricultural and agri -food products, which amounts to an extraterritorial application of 
the standards governing the methods used to process and produce such products. This 
extraterritorial ap plication of measures to protect human, animal or plant health, or to protect the 
environment, is contrary to GATT principles, which provide that standards can only be applied by a 
State Party in the territory over which it has sovereignty or jurisdiction,  and that any exception 
intended to justify restrictive measures may be adopted to protect legitimate objectives within the 
territory of the State imposing the inconsistent measure, but not to protect its legitimate objectives 
in the territory of another S tate. 
2.432.   The delegation of Uruguay  provided the following statement. We support the comments 
made by the preceding Members and reiterate our trade and systemic concern relating to the 
European Union's use of a hazard -based approach, instead of an approach bas ed on full scientific 
risk assessments, when making regulatory decisions concerning the authorization of active 
substances used in plant protection products and when setting import tolerance levels for substances 
that meet the cut -off criteria in Regulatio n No. 1107/2009. We again emphasize the need to base 
such determinations on conclusive scientific evidence, gathered from an assessment of the actual 
risks, to avoid some of these active substances, which remain important components of pest 
management syst ems, having to be withdrawn despite being safe to 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 production, while contributing little or nothing to the cited ai m of protecting public health.  
2.433.   With respect to the announcements regarding the consideration of environmental impact 
when assessing MRLs for active substances that are no longer approved in European Union territory, 
we take note of notification G/TBT/N/EU/908 , submitted on 6 July, re garding the substances 
clothianidin and thiamethoxam. We wish to submit some preliminary observations and questions of 
a systemic nature: First, we are confused by the fact that this measure was notified to the TBT 
Committee and proposed for discussion in this forum, bearing in mind that, from the first time this 
STC was raised at the March 2019 meeting to the most recent meeting of March 2022, three years 
later, the European  Union has stated that, as a matter of principle, concerns relating to the setting 
of MRLs for pesticides and any specific question related to their application are matters to be debated 
before the SPS  Committee, not the TBT Committee. We note that, as reflected in the European 
Union's statement under that same STC in the meeting of 13 J uly, this delegation seems to have 
changed its position, by stating that only MRL reductions owing to human health -related concerns 
fall within the remit of the SPS Committee and they must be discussed in that context. The European 
Union clarified that cer tain specific MRL reduction measures owing to environmental concerns of a 
global nature (as is the case of the two substances mentioned above) must be notified to the TBT 
Committee, and invited Members to discuss such matters in this Committee alone, altho ugh it seems 
to suggest that the SPS Committee would also be informed of such notifications.  G/TBT/M/87  
 
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  2.434.   Our initial questions are: Could the European Union clarify this point and, in particular, 
explain its apparent change of position in this meeting compared to the position it has maintained 
at least since the meeting of this Committee in March 2019? Are we correct in our understanding 
that the European Union will keep the Committee apprised of these regulatory changes, even it 
justifies them in environmental terms? If so, through what channel? Will it use a separate notification 
or other means? Is the European Union considering an MRL reduction for other active substances on 
the grounds that they are "environmental concerns of a global nature"? If so, could the Europ ean 
Union provide a list of the substances under consideration? Is the European Union assessing the 
possibility of reducing the MRLs of active substances based on other grounds or objectives that are 
also not covered by the SPS Agreement? Could the Europea n Union specify what other grounds or 
objectives it regards as appropriate justification for reducing the MRLs of active substances?  
2.435.   Uruguay regards MRLs as a type of measure intended to protect consumer health from the 
risks posed by ingestion and believ es that they therefore fall within the scope of the SPS  Agreement. 
Accordingly, these issues are covered by the multilateral frameworks recognized by this 
Organization, such as the Codex Alimentarius. We have some doubts as to the legal basis, under 
both C ommunity law and WTO rules, for reducing MRLs on the grounds of "environmental concerns 
of a global nature" or for other reasons unrelated to human health. By way of example, we note the 
MRL definition in article 3 (d) of Regulation No. 396/2005 on maximum  residue levels of pesticides: 
"the upper legal level of a concentration for a pesticide residue in or on food or feed set in accordance 
with this Regulation, based on good agricultural practice and the lowest consumer exposure 
necessary to protect vulnera ble consumers". Uruguay wishes once again to highlight the importance 
for the sanitary and phytosanitary measures adopted or applied by WTO Members, including the 
European Union, to be consistent with the objectives set forth in Annex A, paragraph 1, of th e SPS 
Agreement and the other substantive obligations thereunder.  
2.436.   In reference to the objective sought by these measures, Uruguay agrees on the importance 
of protecting the environment and pollinators. We note, however, that at the multilateral level there  
seems to be a lack of clarity regarding the definition of "environmental concerns of a global nature" 
as referenced by the European Union, and regarding the best way in which to address such issues 
at the international level, especially when dealing with aspects linked to international trade or areas 
that fall within the jurisdiction of third countries. Accordingly, Uruguay reiterates its willingness to 
cooperate with other Members, including the European Union, on mechanisms that seek to achieve 
these obj ectives by fully recognizing the capacity of the authorities of third countries to adopt the 
measures that they deem appropriate or necessary to balance the goal of safeguarding food 
production with other legitimate objectives, such as protecting the envir onment or human, animal 
or plant health. As always, Uruguay continues to support the multilateral work undertaken on the 
Codex  Alimentarius to develop a harmonized, risk -based approach to the processing of 
phytopharmaceutical products that ensures the prot ection of health, while facilitating international 
trade in food products. In the meantime, we once again call on the European Union to listen to and 
address the concerns expressed by a number of Members, and to reconsider its regulatory approach 
with a vi ew to preventing the unjustified proliferation of barriers to international trade in agricultural 
products and the serious social and economic consequences of such an approach for other Members, 
in particular developing and least developed countries.  
2.437.   The d elegation of Ecuador  provided the following statement. Ecuador supports and agrees 
with the points and doubts expressed in the statements made by previous speakers.  Ecuador 
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 European Union (EU) to take into account 
scientific information emanating from 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 Committee on Technical Barriers to Trade related 
to good regul atory practices, particularly with regard to carrying out a Regulatory Impact Analysis 
prior to the issuance of regulatory proposals, which examines all possible social, economic, 
environmental and health impacts.  This is to ensure compliance with the obli gation 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 that, in cases where 
there is a lack of scientific infor mation, 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 technical barrier to trade.  G/TBT/M/87  
 
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  2.438.   The delegation of Argentina  provided the following statement. Argentina once again 
reiterates its concern regarding this matter and stresses the importance of ensuring that all Members 
implement measures based on risk assessments, taking account of the ris k assessment techniques 
developed by international reference bodies.  The latter include the principles for establishing 
pesticide MRLs, as well as the many risk analyses that, over the decades, the Codex Alimentarius 
has conducted to ensure safety in terms  of MRL recommendations for different substances and crops.  
Argentina joins the other delegations and reiterates its request to the European Union to ensure that 
the implementation of its regulations is based on the use of risk assessments through the appl ication 
of criteria supported by sufficient scientific evidence, in line with the commitments established in the 
TBT Agreement.  
2.439.   In response, the delegation of the European Union  provided the following statement. The 
European Union thanks WTO Members for th eir interest in the ongoing work in the EU on identifying 
endocrine disruptors for plant protection products. The EU reiterates that the scientific criteria to 
identify endocrine disruptors for plant protection products based on the WHO definition are appl icable 
since 10 November 2018 onwards and included in Commission Regulation (EU) No 2018/605.100 This 
is complemented by a guideline by the European Food Safety Authority (EFSA) and the European 
Chemicals Agency (ECHA), providing more details on how to inte rpret these criteria.101 
2.440.   We are aware of general concerns on EU policy on plant protection products for the definition 
of scientific criteria to identify endocrine disruptors and on the establishment of import tolerances 
for substances not authorized in the  EU, due to the so -called "cut-off" criteria in Regulation (EC) No 
1107/2009102 on plant protection products. As previously explained, the European Union decided to 
follow the procedures of Regulation (EC) No 396/2005 for the management of import tolerance 
requests concerning active substances falling under these cut -off criteria, 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. During the thematic 
session on Trade Facilitating Approaches to Pesticide MRLs, in the margins of the SPS Committee of 
22 March 2022, th e EU provided an overview of the methodology used in EU for pesticide residues 
risk assessment.103 The EU reiterates its commitment to act in full transparency and keep Members 
duly informed about further developments.  
2.1.3.55   India - Air Conditioner and its relate d Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/74 , G/TBT/N/IND/110  (ID 598104) 
2.441.   The delegatio n of China  provided the following statement. China has raised concerns at 83th -
87th TBT meetings regarding the Air Conditioner QCO. In the 87th meeting , India stated that BIS 
will restart the factory inspection for the foreign manufacturers and require no quarantine and RT -
PCR testing for the BIS officers upon arrival. China believes that the above conditions for factory 
inspection for foreign manufacturers violate the non -discrimination principle of the WTO. Therefore, 
China would like to raise concerns as  follows: 1.1 China would like to request India to provide further 
information and clarify whether the entry epidemic prevention policy of the Member where the 
foreign manufacturer is located is a prerequisite for restarting factory inspection. China sugge sts 
that India, in accordance with Article 5.1.1 of the TBT Agreement, consider restarting the factory 
inspection for the foreign manufacturers to ensure that manufacturers in China and other Members 
can obtain the same access as Indian manufacturers. 1.2 China would like to suggest a further delay 
of the entry time of the Air Conditioner QCO due to the pandemic. 1.3 We still suggest that India 
implement alternative measures during the pandemic, such as temporary factory audit exemption 
for a limited period  or virtual audit, or conduct audits through third -party agencies, to address the 
difficulties of physical inspection resulting from international travel restrictions.  
 
100 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting prop erties. OJ L 101, 
20.4.2018, p. 33.  
101 https://doi.org/10.2903/j.efsa.2018.5311   
102 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives  79/117/EEC 
and 91/414/EEC. OJ L 309 24.11.2009, p. 1.  
103 https://www.wto.org/english/t ratop_e/sps_e/thematicsession220322_e.htm   
104 For previous statements follow the thread under ID 598 . G/TBT/M/87  
 
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  2.442.   In response, the delegation of India provided the following statement. The QCO 41/2015 -
2020 dated 15 December 2020 was necessary to apply standards in reducing risks to human, animal 
and plant life and health. Besides, it is consistent with India's commitment to the Montreal Protocol. 
Further, as per the Ozone -Depleting Substances (Regulation  and Control) Amendment Rules 2014, 
the import of air conditioners containing Group VI substances (HCFCs) has been prohibited since 
1 July 2015. Presently, the implementation date of Air Conditioner QCO has been extended by one 
year and will now come into effect from 1 January 2023. At present, there is no provision in BIS 
(Conformity Assessment) Regulations, 2018 to undertake virtual audits for conformity assessment 
activities as an alternative. Foreign inspections were on hold due to the prevalent restric tions on 
International travel imposed. As the COVID restrictions have eased out, BIS has started carrying out 
inspection where confirmation for travelling of fully vaccinated BIS officers has been received. BIS 
has nominated officers and applicants are ask ed to remit the inspection charges for carrying out 
inspection. On receipt of inspection charges, inspections are being planned. Preliminary inspection 
for more than 100 applications has already been carried out. However, in some cases inspection are 
being  delayed due to difficulty in issuance of visa. Further, sufficient capacity for testing room air 
conditioners is available in BIS -recognized laboratories. Bureau of Indian Standards, under its 
laboratory recognition scheme (BIS LRS), grants recognition to  laboratories for testing of products 
as per the relevant Indian Standards. Clause 12 of BIS LRS deals with the recognition of overseas 
laboratories. The decision regarding recognition of overseas laboratories will be taken by BIS taking 
into account the M RA (Mutual Recognition Agreement) with the concerned countries.  
2.1.3.56   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 659105) 
2.443.   The delegation of Australia  provided the following statement. Australia recognizes the EU's 
right to take measures necessary to protect human health and safety, and to ensure wine is labelled 
in a manner that is not misleading to consumers. Australia thanks the EU for their engagement to -
date in this committee and for the clarity they have p rovided around the EU's wine labelling 
requirements. This issue remains an ongoing concern and barrier for Australia's wine industry, and 
we note the Australia -EU Wine Agreement Joint Management Committee also provides an important 
forum where we may discu ss this issue further bilaterally. Further engagement with the EU is 
appreciated as we continue to work through this issue to ensure a mutually satisfactory outcome.  
2.444.   In response, the delegation 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 in accordance with Regulation (EU) No 1308/2013106 establishing a 
common organization of the markets in agricultural products and De legated Regulation (EU) No 
2019/33.107 The importer is a natural or legal person or a group of such persons established in the 
EU assuming responsibility for bringing into circulation non -Union goods within the meaning of 
Article  5(24) of Regulation (EU) No  952/2013108 on the Union Customs Code. Any other indication 
on the label mentioning the entity that brought the wine into another third country before import 
into the Union could be only acceptable as an optional particular, provided it does not appear in 
combination with the words "importer" or "imported by (…)" and is not misleading for consumers as 
regards the business food operator (i.e. the person assuming responsibility for bringing the wine 
into circulation in the EU). The EU reiterates that it is no t possible to list "importers " for multiple 
destinations on the same wine bottle label.  
 
105 For previous statements follow the thread under ID 659 . 
106 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing a common organisation of the markets in agricultural products and repeali ng Council Regulations 
(EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, OJ L 347, 20.12.2013, p. 
671. 
107 Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) 
No 1308/2013 of the European Par liament and of the Council as regards applications for protection of 
designations of origin, geographical indications and traditional terms in the wine sector, the objection 
procedure, restrictions of use, amendments to product specifications, cancellation  of protection, and labelling 
and presentation, OJ L 9, 11.1.2019, p. 2.  
108 Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 
laying down the Union Customs Code, OJ L 269, 10.10.2013, p. 1.  G/TBT/M/87  
 
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  2.1.3.57   Indonesia - Import quota and SNI certification requirements (ID 728109) 
2.445.   The delegation of China  provided the following statement. 1. It is suggested that Indonesia 
could  notify WTO as regards the changes of relevant measures in a timely manner, providing other 
members a 60 -day comment period and taking Members' comments into account. 2. It is suggested 
to cancel the restriction that an auditor shall only audit one product  category for one factory at a 
time, and only Indonesian entities employ Indonesian citizens, and residents of Indonesia to carry 
out certification activities. 3. It is suggested that Indonesia resume remote factory inspection or 
allow third -party testing and certification bodies to conduct assessments. In addition, China would 
like to suggest that Indonesia could increase the number of SNI accreditation bodies and testing 
laboratories outside Indonesia.  
2.446.   In response, the delegation of Indonesia  provided the  following statement. Indonesia thanks 
China for its interest on Indonesia's import quota and SNI certification requirements. Indonesia 
would like to refer to its last statement in the March 2022 TBT Committee meeting that all 
certification process for tec hnical regulations based on SNI in the industrial sector is carried out in 
accordance with the provisions stated on the related Minister Regulation. All technical regulations 
based on SNI have also been notified to the TBT Committee which provides a commen ting period of 
60 days. Indonesia accepts testing results from accredited foreign testing laboratories under the 
framework of ILAC Arrangement and availability of technical regulation agreements between 
Indonesia and its country partners.  
2.1.3.58   India - Import Po licy of Air Conditioners with Refrigerants (ID 748110) 
2.447.   The delegation of Thailand  provided the following statement. Thailand thanks India for the 
statement pertaining to our concern on the prohibition of the import of air conditioners with 
refrigerants in t he 86th Committee on TBT meeting. However, Thailand would like to request India 
to 1) provide evidence that Notification No.41/2015 dated 15 October 2020 issued by the Ministry 
of Commerce is consistent with the provisions of the Montreal Protocol; 2) clar ify the types of 
refrigerants that are prohibited to import to the country; 3) provide evidence that the regulation to 
prohibit the production and usage of refrigerants is applied within the country prior to applying to 
the import of refrigerants from othe r countries; 4) elaborate plan to cease production of air 
conditioners with the prohibited refrigerants in the country; and 5) notify the measure to WTO TBT. 
Thailand would appreciate India's consideration of our concerns and reviewing the measure in a les s 
restrictive manner by taking into account the non -discrimination principles to avoid creating 
unnecessary barriers to trade.  
2.448.   In response, the delegation of India provided the following statement. India would like to 
thank Thailand for their statement and interest in the issue and for the bilateral engagement earlier 
on. The measure in question was necessary to apply standards in reducing risks to human, animal 
and plant life and health. Besides, it is consistent with India's commitment to the Montreal Protocol. 
Further, as per the Ozone -Depleting Substances (Regulation and Control) Amendment Rules 2014, 
the import of air conditioners containing Group VI substances (HCFCs) has been prohibited since 
1 July 2015.  
2.1.3.59   Republic of Korea - Regulation for supporting low carbon solar module product 
(ID 744111) 
2.449.   The delegation of China  provided the following statement. 1. The life cycle assessment (LCA) 
report submitted by the Chi nese Company in accordance with ISO14040 has not been recognized 
by the ROK, while the report based on the same calculation method has been recognized by EU 
member States. China hopes that Korean side could clearly explain its implementation criteria for 
the review of the LCA report. Before formulating/issuing the implementation criteria for the LCA 
report review, the submitted reports should be reviewed in accordance with ISO and other 
international standards, and the report review process and requirements  should be made public. 2. 
The ROK side should publish the list of qualified third -party certification institutions for companies' 
choices. 3. The reviewing time of the report should consider the time needed in other Members, that 
is, approval shall be com pleted within 30 days after acceptance, so as to improve efficiency. 4. As 
 
109 For previous statements  follow the thread under ID 728 . 
110 For previous statements follow the thread under ID 748 . 
111 For previous statements follow the thread under ID 744 . G/TBT/M/87  
 
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  too much trade secret data and industry -sensitive information are submitted which is unnecessary 
and unreasonable, the ROK side should reasonably set the scope of data submission in  accordance 
with international practice.  
2.450.   In response, the delegation of the Republic of Korea  provided the following statement.  1. 
The LCA report review process and verification standards are disclosed on the website through KEA 
(Korea Energy Agency)'s re lated business regulations and verification guidelines. Since there are no 
international standards or guidelines for assessing carbon emissions of solar module products, the 
relevant regulations of the Korea Energy Agency serve as the basis of the report r eview process. 2. 
Korea does not publish a list of qualified third -party certification institutions as it may limit the 
participation of other LCA certification service providers and the freedom of choice for companies. It 
is also impossible to fully under stand the status of global LCA certification service providers as well 
as their expertise. Therefore, only those with past experience in implementing LCA are regarded as 
qualified service providers. In addition, to ensure the fairness of the assessment pro cess, chosen 
LCA service providers must submit confirmation of their independence, transparency and 
compliance. 3. There are no rules and regulations regarding the LCA report review period. However, 
the review process initiates as soon as a report is submi tted to ensure the process is carried out 
swiftly. To accelerate the review process, requested documents and data must be submitted in a 
swift manner. Once the Certification Deliberation Committee grants its final approval, companies will 
be issued their c ertification within at least one week. 4. Korea only requires the essential information 
for assessing greenhouse gas emissions, and does not require any trade or business -sensitive 
documents. Information on electricity consumption during the manufacturing period of solar modules 
as well as emissions calculation methods must be submitted as they are essential for evaluating 
carbon emissions. Therefore, it is impossible to guarantee the reliability of any report and evaluate 
greenhouse gas emissions without d isclosing such essential information.  
2.1.3.60   European Union - Regulation (EU) 2022/30 on network protection, safeguards 
for the protection of personal data and privacy and protection from fraud, 
G/TBT/N/EU/823  (ID 743112) 
2.451.   The delegation of China  provided the following statement. Regulation ( EU) 2022/30 is a 
framework rule, which only specifies the scope of products. The regulation lacks detailed descriptions 
of testing standards and conformity assessment procedures. Manufacturers cannot assess a 
product's regulatory compliance, and understand  the actual impact on the product of testing 
standards and conformity assessment precisely, which will largely influence the follow -up design 
plan of the product. As the regulation covers so many different types of products, it has great and 
complex impact s. After the publication of the standard, manufacturers will need at least 12 months 
to redesign (if involved), conduct conformity assessment, and prepare all relevant documents 
required by the regulations. 1. China proposes the EU release relevant testing  standards and 
conformity assessment guidance documents as soon as possible, or at least a publication schedule, 
ensuring that manufacturers can conduct product regulatory compliance analysis in advance and 
modify product design in time to meet regulatory requirements. Besides, China hopes that 
enterprises can take part in the legislative process.  
2.452.   2. It is recommended that relevant guidelines could be issued as soon as possible to facilitate 
enterprises to make compliance preparations in advance. Please cla rify the types of equipment 
complying with 3.3D/E/F in guidelines. For example, Bluetooth headsets, Bluetooth speakers, smart 
curtains, smart bulbs, and other products without the function to directly connect to the Internet, 
only connect through Bluetooth  modules or through mobile apps, which belongs to indirect 
networking. Do these devices need to meet the 3.3d/e/f requirements? 3. We noted that there is a 
detailed Notify Body list of the RED Directive on EU official website. With the enforcement of RED 
3.3 d/e/f, we suggest that the EU could re -assess and delegate Notify Body corresponding to the 
new requirements of RED and could release relevant information as soon as possible. In addition, 
the regulation only provides transition period of 30 months, ple ase make further market research to 
ensure the certification resources.  
2.453.   4. Cyber Resilience Act proposed in September 2021. The EU states that Cyber Resilience 
Act will supplement the existing EU legislative framework, including the NIS Directive and the Cyber 
Security Act. Please clarify the relationship between EU 2020/30 and Cyber Resilience Act. 5. It is 
our understanding that the EU 5G Scheme compatible with EU 2019/881 is being prepared. While in 
 
112 For previous statements follow the thread under ID 743 . G/TBT/M/87  
 
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  EU 2020/30 5G base stations are subject to 3.3d the ne twork security requirements of the RED 
Directive. Please clarify the rules for 5G base stations network security and avoid duplication and 
conflicts of certification results.  
2.454.   In response, the delegation of the European Union  provided the following statemen t. This 
Delegated Regulation was notified on 23 July 2021 with a 60 -day commenting period under reference 
number G/TBT/N/EU/823 . China submitted comments on 18 September 2021 to which the EU replied 
on 4 November 2021. In its comments, China raised several issues, one of which was th e 
recommendation to extend the transition period of 30 months. In this regard, the EU provided in its 
reply that the proposed transition period reflects the balance between the various interests and 
concerns at stake. On the one hand, the public interest r equires to swiftly reinforce the level of 
protection offered by certain radio equipment placed on the EU market. On the other hand, 
stakeholders need time to adjust. China also recommended that the EU consider the feasibility of 
classifying the products of  different risks, to which the EU provided that the measure renders 
applicable some of the essential requirements established in Article 3(3) of Directive 2014/53/EU to 
certain categories or classes of radio equipment. The choice of the specific categories  or classes of 
radio equipment to be covered has been guided by the existence of particular risks associated with 
these types of radio equipment. A risk analysis would also have to be performed by the European 
Standardisation Organisations in the process o f elaborating the relevant standards. The Commission 
Delegated Regulation 2022/30 was adopted on 29 October 2021.  
2.1.3.61   India - Approved models and manufacturers of solar photovoltaic modules order, 
2019 (ID 742113) 
2.455.   The delegation of China  provided the following statement. 1. The Indian F.NO.283/54/2018 -
GRID SOLAR "Approved Models and Manufacturers of Solar Photovoltaic Modules Order, 2019" 
distinguishes between imported and domestic products manufacturers, and imported products and 
manufacturers are treated unfav ourably. In terms of review and feedback time, overseas enterprises 
are discriminated. The overseas enterprise is in less favourable competition conditions, while Indian 
domestic manufacturers have advantages and are protected. It is not consistent with th e National 
Treatment principle of GATT and Articles 2.1, 5.1 and 5.2 of TBT Agreement. China suggests that 
the Ministry of New and Renewable Energy (MNRE) of India and the National Institute of Solar Energy 
(NISE) adjust the measures, and treat domestic an d foreign companies equally, besides, the audit 
process and time schedule should be publicized, so as to improve the certification efficiency.  
2.456.   2. In NISE's Documentation and On -Site verification process, the certification standards and 
process rules are no t clear, lack of guidance for the manufacturers, no effective feedback and 
communication in ALMM audit application process. It is against the transparency principle in GATT 
and TBT Articles 5.1, 5.2 and 5.6. Clear certification standards and auditing proce ss should be 
publicized. 3. After charging Chinese companies for high ALMM application and testing fees, on -site 
inspection and audit have been delayed due to the COVID -19 pandemic. Considering the persistence 
of the global epidemic and foreseeable travel restriction, It is obviously not possible for on -site 
inspection of overseas manufacturers. Alternative solutions should be considered, such as entrusting 
a Chinese certification body to conduct on -site inspection to support the necessary remote video 
inspection. Besides, we request the Indian side to postpone the implementation of the ALMM Act 
until eight months after the completion of the on -site inspection.  
2.457.   4. The fees charged for ALMM certification were unreasonable. Currently, ALMM certification 
fee is  evaluated and charged according to the total production capacity of the manufacturer, which 
is much higher than the actual production capacity quota allocated for export to Indian market. 
Therefore, this measure is against the obligation to control the fe e in Article 8.1(a) of GATT, not to 
create unnecessary obstacles to trade in the TBT Agreement. It is recommended that the Indian side 
follow the agreement and set a reasonable price standard. 5. From the perspective of the necessity 
for the formulation of  the Decree (The Approved Models and Manufacturers of Solar Photovoltaic 
Modules Order, 2019 (ALMM) (Compulsory Registration Requirements), the requirements of BIS 
certification can indeed fully fulfill the purpose of ensuring the quality of photovoltaic m odules, and 
the additional ALMM certification list is unnecessary, burdensome and become an obstacle to trade. 
2019 ALMM Decree restricts trade while no further contribution to achieving legitimate objectives, it 
is against Article 2.2 of TBT. China sugges ts that India withdraws the ALMM decree.  
 
113 For previous statements follow the thread under ID 742 . G/TBT/M/87  
 
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  2.458.   In response, the delegation of India provided the following statement. 1. The Indian 
Government vide F.N0.283/54/2018 - GRID SOLAR "Approved Models and Manufacturers of Solar 
Photovoltaic Modules Order, 2019 (' ALMM Order') provides for enlistment of eligible models and 
manufacturers of solar PV cells and modules complying with the BIS Standards and publish the same 
in a list called the "Approved List of Models and Manufacturers" (ALMM). The registration process 
and conditions prescribed are uniform irrespective of the nationality of the manufacturer. In other 
words, no distinction is made between domestic producers and overseas producers. There are no 
separate provisions for domestic producers and overseas produc ers with respect to review and 
feedback time. There may be some delay with respect to overseas producers due to logistical issues, 
however, the same cannot be considered as being discriminatory or unreasonable. India requests 
China to provide more details in this regard. India will review the information and provide its 
response.  
2.459.   2. India has published ALMM Order, Guidelines, Application formats and necessary FAQs on 
its website.114 The ALMM Order and Regulations are transparent and clearly spell out the pro cess 
and the documentation requirements for enlistment under the ALMM List. However, India welcomes 
any suggestions on further improvement of the certification standard and process and will consider 
such suggestions with an open mind. 3. Foreign inspection  visits were on hold due to restrictions on 
international travel because of the ongoing COVID -19 pandemic. As the situation of COVID -19 
improves and the restrictions are eased, inspections will be planned by NISE. There is no provision 
in ALMM Order or Reg ulations for remote assessment or any other means for inspection. 4. Under 
the ALMM Order and Guidelines, a standard fee has been prescribed for all entities which wish to 
enlist under the ALMM scheme. The said regulation states as under:  
2.460.   3.1 The applicati on fee for one model of module /cell shall be Rs. 5,000/ - per MW of the 
total installed manufacturing capacity for solar PV modules and Rs. 5, 000/ - per MW of the total 
installed manufacturing capacity for solar PV cells, of the applicant. However, as a me asure of further 
facilitation to small manufacturers, for PV module manufacturers having total installed 
manufacturing capacity less than or equal to 50 MW, the application fee for one model of module is 
Rs.2,500/ - per MW of the total installed manufacturi ng capacity for solar PV modules, of the 
applicant. 3.2 The "model" as mentioned in (3.1) above, refers to modules / cells of same nominal 
power output rating. All BIS approved modules/ cells of the applicant with same nominal power 
output rating shall be treated as one model. 3.3 In case the application consists of multiple models, 
the application fee shall be as per 3.1 above for one model and additional 1% of this for every 
additional model. 4.1 The fee has been determined based on total installed manufa cturing capacity 
as ALMM is intended in respect of manufacturer and total capacity and not actual production or 
export quota. It is also important to note that the said application fee and other charges are uniform, 
irrespective of nationality of the produ cer — whether Indian or overseas producers. 4.2 Article 
VIII(1) (a) of GATT 1947 states that "All fees and charges of whatever character (other than import 
and export duties and other than taxes within the purview of Article III) imposed by contracting 
parties on or in connection with importation or exportation shall be limited in amount to the 
approximate cost of services rendered and shall not represent an indirect protection to domestic 
products or a taxation of imports or exports for fiscal purposes." 4 .3 As stated above, the application 
fee charged under ALMM regulations is commensurate with the services provided and is uniform 
irrespective of nationality of the producer. Thus, the application fee cannot be considered as an 
indirect protection to domest ic products or as charges additional levied only on imports. 4.4 Thus, 
India considers that the application fee charged under ALMM regulations is consistent with 
Article  VIII (1) (a) of GATT 1947 and the said fee is unlikely to cause unreasonable burden or  
restrictions on international trade.  
2.461.   5. The BIS certification requirement deals with quality control of the solar cells and modules. 
The ALMM Order provides for enlistment of eligible models and manufacturers of solar PV cells and 
modules complying with t he BIS Standards. While BIS certification is with respect to maintaining the 
quality of the product per se, ALMM certification intends to enlist eligible models and manufacturers, 
producing the said solar cells and modules. ALMM is thus, aimed to ensure th e reliability of the 
producers of the enlisted models. Thus, ALMM and BIS certifications are reasonable requirements in 
the larger public interest to ensure quality of the product as well as ensure reliability of the producer. 
ALMM intends to plug this asp ect to ensure protect consumer interests and ensure larger energy 
security of the country, which BIS does not provide.  
 
114 https://mnre.gov.in/solar/manufacturersand -quality -control .  G/TBT/M/87  
 
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  2.1.3.62   European Union - Commission implementing decision (EU) 2017/1357 on a 
restriction of Standard EN 60335 -2-9-2003+A 13 -2010 (ID 741115) 
2.462.   The delegation of China  provided the following statement. At present, the safety 
requirements on air fryers are in standard EN 60335 -2-9-2003+A13 -2010. However, the European 
Commission has restricted some provisions of EN 60335 -2-9-2003+A13 -2010 in its commiss ion 
implementing decision (EU) 2017/1357, which points out that the provision "exemption from surface 
temperature rise test for surfaces within 25mm from the edge of the cover and the air outlet" does 
not comply with 1 (c) of Appendix I of 1(c) of Annex I of Directive 2014/35/EU. The air fryer is a 
kind of portable electric household appliance that uses convection of hot air and requires internal 
and external circulation to heat food, the principle of which is fundamentally different from that of a 
conventi onal oven. In addition, Germany, one of the initiators of the commission implementing 
decision (EU) 2017/1357, also separate the safety requirements for air fryer products in the 
instruction manual for the implementation of the European Electrotechnical Co mmission (EEC) 
Guideline No.29 and exempt the surface temperature rise test within 25mm from the edge of the 
cover and the air outlet of the air fryer. If the EU cannot separate the requirements for air fryers, 
then most air fryers on the market could not meet the EU market access requirements, which means 
the harmonized standard is infeasible. a. China suggests that the EU reassess the implementing 
decision (EU) 2017/1357 and exempt the temperature rise test requirement within the 25mm 
surfaces of the air outlet of the air fryer. b. China suggests the EU reconsider the products 
classification according to the working principle of air fryers and develop safety requirements and 
test method standards that are compatible with them. c. As the EU is also consider ing improving the 
standard EN 60335 -2-9:2003+A13:2010, China is willing to have technical exchanges and 
cooperation with the EU on the requirements and test standards related to the classification of air 
fryers.  
2.463.   In response, the delegation of the European Union  provided the following statement. Thank 
you to the delegation of China for its interest in the Commission Implementing Decision (EU) 
2017/1357 of 19 July 2017 on a restriction of the standard EN 60335 -2-9:2003, "Household and 
similar electrical appli ances — Safety -- Part 2 -9: Particular requirements for grills, toasters and 
similar portable cooking appliances", as last amended by A13:2010. The Commission Implementing 
Decision follows a formal objection by Germany and Norway respectively in June 2014 and July 
2014. The formal objections of Germany and Norway stated that Section 11 "Heating" of the 
standard includes insufficient provisions regarding temperature limits of accessible non -functional 
surfaces. In particular, the standard allows several excl usions to the temperature limits, authorising 
the manufacturer to double or not to apply the temperature limit values depending on the size, 
design or the surface part of the appliance, and requiring at most a warning notice or label. In this 
respect, Sect ion 7.1 of the standard only requires a warning to be put on the surface with the highest 
temperature within the parts exceeding the limit values. The colours of the warning label may differ 
from international warning colours which may confuse the users. A dditionally, as a result of the 
ambiguity of the requirements under the standard, the standard can be interpreted as making it 
possible to omit the measurement of the temperature rises in certain parts of a given product, which 
may lead to the disregard of  or doubling of the temperature limit values applicable under the 
standard with regard to the entire product.  
2.464.   As a result, the risk of burning for persons and domestic animals is still present and the 
standard as such should not give the presumption of con formity with Directive 2014/35/EU. Having 
examined standard EN 60335 -2-9:2003, as last amended by A13:2010, in the Low Voltage Directive 
Working Party, which is a group of sectoral experts, together with EU member States and 
stakeholders, the European Comm ission together with the majority of experts from member States 
agreed with the arguments presented by Germany and Norway. Consequently, it was concluded that 
the standard fails to meet the safety objectives laid down in point 1(c) of Annex I to Directive 
2014/35/EU, in conjunction with point 2(b) of that Annex. Taking into consideration the safety 
aspects to be improved and pending a suitable revision of the standard, the Commission 
Implementing Decision provides for the relevant restriction in its Annex 1 , namely that the concerned 
restricted parts do not confer a presumption of conformity. Since the raise of the formal objection 
and the publication with restriction of the standard EN 60335 -2-9, the Commission continuously puts 
effort, together with stakeh olders and European Standardisation Organisation, to reach a new 
version of the standard, which would fulfill the objectives of the Low Voltage Directive 2014/35/EU. 
The EU would like to emphasize that the concerned standard fulfils the definition of a sta ndard as 
 
115 For previous statements follow the thread under ID 741 . G/TBT/M/87  
 
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  contained in Annex 1 point 2 of the TBT Agreement, namely that it is a, "Document approved by a 
recognized body, that provides, for common and repeated use, rules, guidelines or characteristics 
for products or related processes and production meth ods, with which compliance is not mandatory. " 
The EU thanks the delegation of China for its willing to have technical exchanges. We are available 
to further cooperate on this.  
2.1.3.63   United States - Secure equipment act of 2021 (ID 737116) 
2.465.   The delegation of China  provided the following statement. In accordance with the Act, the 
Federal Communications Commission prohibits authorization of radio communication equipment, 
which pose a national security risk to the US. Without concrete evidence, the US restricts the 
authorization of radio communication equipment produced by some Chinese companies which are 
against TBT rules. Therefore, China proposes that the United States should abide by WTO/TBT rules 
and treat all the Members' products and enter prises equally, providing fair and non -discriminatory 
market access for all Members.  
2.466.   In response, the delegation of the United States  provided the following statement. The FCC 
is charged with issuing implementing regulations, and those proposed regulations  are scheduled to 
be developed and published by 22 November 2022 and they actually have been notified to the WTO 
TBT Committee. I would like to refer to STC ID 714 which are the implementing regulations. I don't 
know if we made that clear last time and pot entially we should combine those two STCs since they 
are referring to the same Act and its implementing measure.  
2.1.3.64   South Africa - Regulations relating to the composition, production and labelling 
of wine and spirits intended for sale in the Republic of Sout h Africa, 
G/TBT/N/ZAF/48/Rev.2/Add.1  (ID 733117) 
2.467.   The delegation of Mexico  provided the following statement. As was mentioned in the 
statement made for STC 7118, we are of the understanding that it is a concern about the same 
measure that was included in the prev ious meeting of the Committee and that now also features in 
STC 80. Despite this duplication, in order to ensure the traceability of concerns, we are making 
statements under both items to keep them separate. The delegation of Mexico refers to its statement  
made at the previous meeting of this Committee in March 2022 on the Regulations relating to the 
composition, production and labelling of wine and spirits intended for sale in the Republic of South 
Africa, notified to the Members of the Committee on 20  December  2021 in document 
G/TBT/N/ZAF/48/Rev.2/Add.1 . Firstly, we thank the Government of South Africa for responding to 
the comments sent during the public consultation period, in which both the Mexican industry and 
Government participated to share observations on what we consider could have an impact on 
Mexican exporters of tequila and mezcal, as well as on potential exporters of raicilla and bacanora.  
2.468.   However, the delegation of Mexico wishes to point out that these concerns remain, since 
South Africa's response  to the comments sent by the Government of Mexico do not address each of 
the remarks made in Official Circular No. 500/RVL/044/2022 of 11 February 2022. In this regard, 
we appeal to the good offices of the delegation of South Africa to address the followin g comments 
relating to concerns stemming from the lack of inclusion in the Regulations of clear definitions for 
beverages of Mexican origin: We ask that, separate from the "100% agave" class, there be a clear 
specific class for tequila that complies with t he applicable Mexican regulations, taking into account 
that tequila has been registered as a certification mark in South Africa since 2004. In order to avoid 
potential confusion among consumers, we ask that no reference be made in the "100% agave" class 
to tequila or its classes or categories, even in Spanish.  
2.469.   We also highlight the request for uniform definitions for Mexico's emblematic beverages, 
such as mezcal, bacanora and raicilla , which have their own origin, physico -chemical specifications 
and identit y characteristics, as established in the respective Mexican Official Standards. In addition, 
and with the aim of following up on our concerns in a timely manner, we would be grateful if the 
delegation of South Africa would provide us with a contact point t hrough which we could regularly 
 
116 For previous statements follow the thread under ID 737 . 
117 For previous statements follow the thread under ID 733 . 
118 South Africa - Regulations Relating to the Labelling of Alcoholic Beverages – Revision . G/TBT/M/87  
 
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  follow up on the development of the Regulations The delegation of Mexico thanks the delegation of 
South Africa for giving its consideration to this statement.  
2.470.   In response, the delegation of South Africa  provided the followin g statement. South Africa 
is of the view that all concerns that were raised by Mexico were addressed in our communication to 
Mexico but it seems this is not the view of Mexico. We would like to recall the statement that we 
made under STC No 7119 to encourag e Mexico to engage with us. We are ready to engage in a 
constructive manner with a view to resolve the STC. We had indicated that our point of contact will 
be the South African Permanent Mission in Geneva.  
2.1.3.65   United States - Energy conservation program: test procedure for circulator 
pumps, G/TBT/N/USA/1815  (ID 731120) 
2.471.   The delegation of China  provided the following statement. a. China proposes the US clarify 
"whether the small vertical in -line pumps include end suction close coupled pumps (ESCC) ". When 
an end suction close coupled pump  is used vertically, it also meets the definition of a small vertical 
in-line pump by the Circulator Pump Working Group (CPWG). b. As in the last meeting, US indicated 
that the proposed definitions can sufficiently address the range of circulator pumps and  that 
schematic diagrams would not provide additional benefit. However, as there is no distinction on 
coupling methods between "mechanically -coupled pumps " and "close-pumps " in China and other 
members. China suggests the US appropriately add schematic diagrams to help understand the 
definitions of "mechanically -coupled pumps " and "close-pumps ", so as to avoid misunderstanding. 
c. For pressure control circulator pumps, the US has given an equation for PERCIRC, please provide 
scientific evidence for PERCIRC weighting assignments to pressure control type circulator pumps. d. 
Section 40.6.4.4 of HI 40.6, to which the US refers, only briefly discusses motor pump units or 
complete p umps. An "integrated design pump " is a pump with associated piping and accessories 
from which the individual pumps cannot be easily separated. China suggests that the US clarify the 
efficiency testing method for this type of pump.  
2.472.   In response, the delegati on of the United States  provided the following statement. The 
United States thanks China for its concerns. We notified Department of Energy's draft regulation to 
the TBT Committee in USA/1815, and the comment period closed on 18 February 2022. We did not 
receive any comment from China or any of its stakeholders. The United States will take into 
consideration all comments received during the open comment period and respond to each 
substantive comment in the next published rulemaking document on Test Procedur es for Circulator 
Pumps.  
2.1.3.66   Mongolia - Draft Law on controlling the circulation of alcohol beverages, and 
fight against alcoholism, G/TBT/N/MNG/14  (ID 730121) 
2.473.   The delegation of Mexico  provided the following statement. The delegation of Mexico refers 
to its statement at the previous meeti ng of this Committee in March 2022, regarding the draft Law 
on controlling the circulation of alcohol beverages, and fight against alcoholism, notified to the 
Members of this Committee by the Government of Mongolia on 12  August  2021 in document 
G/TBT/N/MNG/14 . During the meeting in M arch 2022, the concerns that this measure is causing for 
Mexican exporters of alcoholic beverages were expressed for the first time, and we reiterate the 
following: It is considered that the ban on sales of these products through electronic channels limits  
the ability to control and trace lawful sales of alcoholic drinks. The ban on alcoholic beverages with 
an alcohol content greater than 35% alcohol/volume would have a direct impact on Mexican exports 
of beverages such as mezcal and tequila, both of which exceed that percentage. The branding -
related restrictions are of concern to Mexican exporters, as branding is an international practice 
intended to inform the consumer of the quality of the products.  
2.474.   The delegation of Mongolia responded positively to the a bove-mentioned concerns at a 
bilateral meeting, at which the following remarks were made. The draft Law has not yet been adopted 
and was modified as a result of the comments received during the consultation period. In the new 
version of the Law, which cont inues to be a draft that is under discussion, the following were 
eliminated: specific provisions that would result in a ban on online sales; the banning of alcoholic 
 
119 South Africa - Regulations Relating to the Labelling of Alcoholic Beverages – Revision . 
120 For previous statements follow the thread under ID 731 . 
121 For previous statements follow the thread under ID 730 . G/TBT/M/87  
 
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  drinks with an alcohol content greater than 35% alcohol/volume; and branding -related restr ictions. 
The new version has not yet been notified. However, efforts will be made to do so six months prior 
to the implementation of the Law. In this connection, the delegation of Mexico is grateful for the 
kind attention paid to concerns and asks the dele gation of Mongolia to provide and notify the new 
final version of the measure as soon as it becomes available, so that it may be reviewed by Members. 
We would also be grateful if Mongolia could indicate the potential date of adoption of this new 
version.  
2.475.   The delegation of Mongolia  was not present in the room .  
2.476.   The delegation of Mexico  stated that Mongolia contacted them saying it was their national 
day and they would not be able to participate which is why we included in our statement the 
responses obtained  in our bilateral meeting with the hope that we will get from Mongolia in the next 
time a revised version of the measure.  
2.1.3.67   European Union - Draft Commission Regulation laying down eco -design 
requirements for electronic displays pursuant to Directive 2009/12 5/EC of the European 
Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and 
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes)", 
G/TBT/N/EU/609 , G/TBT/N/EU/610  (ID 575122) 
2.477.   The delegation of the Republic of Korea  provided the following statement. Korea apprec iates 
this opportunity to deliver our opinions on the European Union's "Commission Regulation (EU) 
2019/2021 of 1 October 2019, laying down Ecodesign Requirements for Electronic Displays". The 
Korean government respects the efforts of the European Parliame nt and the Council to inform 
consumers and protect the environment by reducing the power consumption of electronic displays. 
Furthermore, Korean companies are endeavouring to comply with the regulation of the EU. However, 
in relation to the Tier 2 requirem ents of the Regulation on Electronic Displays, which is scheduled to 
be enforced in March 2023, a Korean Electronics Association had sent a position paper to the EU in 
April, expressing concerns from the relevant industries in Korea. However, the EU replie d that it is 
not considering any review on the Tier 2 requirements. To this, the Korean government officially 
submitted its comments through the EU's WTO TBT Enquiry Point on 30 June 2022, with regard to 
the industry's difficulties and requests. Firstly, t he regulatory scope of Tier 2 requirements will 
encompass electronic displays with resolution above UHD -4K and MicroLED displays. Korean 
manufacturers have been making efforts in improving the technology to reduce the power 
consumption of the above -UHD-4K resolution display and MicroLED display products. Despite these 
efforts, it seems that the manufacturers need more time to improve the technology and reduce 
energy consumption significantly to meet the Tier 2 requirements.  
2.478.   For 8K Display products, it can b e demonstrated by the fact that all models from 
manufacturers currently in the EU territory do not satisfy the Tier 2 requirements. We are concerned 
that, if the regulation is enforced as scheduled, none of the above -UHD-4K resolution displays and 
MicroLED  display products can be placed on the EU's markets, limiting the EU consumers' choice of 
product and hindering the technological development of related industries. In case there is a product 
among the 8K displays released in the EU that, contrary to our k nowledge, satisfies the Tier 2 
requirements, we would like to ask the EU to provide such an example. Secondly, it is considered 
unreasonable to apply the same Energy Efficiency Index limit (EEI limit) to "the displays with 
resolution above UHD -4K" as those  to "the UHD -4K or lower resolution displays". In general, "above 
UHD-4K displays' consume more energy as they require lighting at least four times brighter than 
that of 'UHD -4K or lower displays". As such, applying the same EEI requirement is overly 
burde nsome to the manufacturers of the above -UHD-4K displays. Just as the EU already applies 
different EEI limits to the "displays above HD and up to UHD -4K" from the "HD displays and below", 
we request the EU to apply different and higher EEI limits for "displ ays above UHD -4K and MicroLED 
displays" from the "displays above HD and up to UHD -4K". In conclusion, the current Tier 2 
requirement has set unrealistic limits based on future assumptions, rather than feasible limits that 
reflect the actual level of curren t technological development. As it is stipulated in Article 8 that the 
regulation shall be reviewed in the light of technological progress, Korea requests that the EU take 
sufficient time to thoroughly review the EEI limits based on the actual energy consu mption data of 
the electronic displays currently in the EU market, and postpone the enforcement of Tier 2 
 
122 For previous statements follow the thread under ID 575 . G/TBT/M/87  
 
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  requirements on displays with resolution above UHD -4K and MicroLED displays until reasonable EEI 
limits have been newly established.  
2.479.   In response, the delegation of the European Union  provided the following statement. This 
measure was notified to the WTO on 9 October 2018 and allowed for 60 days of comments. The 
energy efficiency requirements for electronic displays have been known since 2019 and are 
applicable since March 2021, except for displays with very high resolutions which benefit from a 
specific, temporary exemption until 1 March 2023. A review of this adopted regulation is not among 
the priorities identified in the Ecodesign and Energy Labelling  Working Plan adopted on 30 March 
2022, given the geopolitical situation and the acute energy crisis in Europe. Therefore, we encourage 
display manufacturers to take advantage of the different flexibilities already available under the 
Regulation. These inc lude allowances for automatic brightness control or specific, advantageous 
rules on how to measure consumption of displays designed for use with standardised external power 
supplies.  
2.2  Exchange of Experiences  
2.2.1   Transparency  
2.2.1.1   Report by the Moderator on the Thematic Session on Transparency  
2.480.   The Moderator123 for the thematic session on Transparency, held on 12 July 2022 and 
covering Product Coverage and Domestic Coordination, provided his report. The full report is 
contained in G/TBT/GEN/330 .  
2.2.1.2   United States proposal on Article 15.2 notifications  
2.481.   The representative of the United States  introduced the proposal for a new notification format 
for Article 15.2 notifications contained in JOB/TBT/466 . One of the recommendations from the Ninth 
Triennial Review was to pursue a change in notification formats to better identify Article 15.2 type 
measures, which were being updated or n ewly developed. Members were already submitting such 
changes, on a voluntary basis, using the notification format for technical regulations and conformity 
assessment procedures, but without a clear indication. Sometimes, they were labelled as "other", 
some times as a "technical regulation". Therefore, the US proposed to add a check box in the 
notification format to reflect more accurately such measures.   
2.482.   With a view to improving the number of updates under Article 15.2, giving these updates 
some structure and  consistency, and also to more accurately account for notice and comment 
opportunities that involve the implementation and operation of the Agreement, the US was proposing 
that the Secretariat revise the Format and Guidelines for New Notifications (of draf t technical 
regulations and conformity assessment procedures)124.  Any new, revised or updated administrative, 
legislative or regulatory actions, including NQI laws and regulations,125 that implement Members' 
obligations or improve the ability of Members in fulfilment of obligations under the WTO TBT 
Agreement, could be notified with a clear link to  Article  15.2. Under item  number 3 in the notification 
template, a checkbox would be included for Article  15.2 notifications. All other information normally 
contai ned in the new notification could continue to be included, and the Coherent Use of Notification 
Formats ( G/TBT/35/Rev.1 ) could also be applied. The ePing TBT notification submission system could 
be modified to allow Members to notify actions directly relevant to Article  15.2, and als o to facilitate 
the distribution of the notified measures that contribute to the implementation of Article 15.2.  
2.483.   When the Article 15.2 check box was checked, it could also trigger the Member to submit a 
revision or supplemental notification in the G/TBT/2 -series  when the measure was finalize d. The 
G/TBT/2 -series  notification could c ontain a table of information, where the Member could include 
the name of the measure, attach a copy of the final measure, the date it was published or approved, 
the date of entry into force, and the location (a link) where it can be found online.  Members had 
submitted their Article 15.2 notifications in the G/TBT/2 -series upon their adoption of the TBT 
 
123 Mr Jia Jie Loh (Singapore).  
124 G/TBT/1/Rev.14 , page 66.  
125 This would include new or updated laws and regulations related to standards, conformity assessment, 
accreditation, and metrology.  G/TBT/M/87  
 
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  Agreement but many had not been updated.  The new process would also facilitate updates to the se 
original statement s. 
2.484.   The representative of China  expressed his delegation's appreciation for the US p roposal 
aimed at strengthening transparency and shared some preliminary comments. Firstly, China 
believed that Quality Infrastructure (QI) was an important part covered in the TBT Agreement and 
that it was of great importance to continuously enforce the qu ality of relevant notifications. 
Therefore, China suggested that the Secretariat organize a dedicated event in this area. Secondly, 
notifications under Article 15.2 and those relating to technical regulations and conformity 
assessment procedures were subje ct to different obligations. He asked whether adding an option for 
measures related to Article 15.2 in the existing notification format would mean that they would also 
be subject to obligations such as the commenting period and the transition period. Third ly, he 
suggested that the US clarify the proposal with examples for a better understanding by Members.  
2.485.   The representative of the United States  responded that these Article 15.2 measures would 
not be subject to the same obligations as a technical regulatio n or a conformity assessment 
procedure . Members , such as Brazil,  were already voluntarily notifying drafts of underlying QI laws 
related to conformity assessment procedures, standards, metrology, and accreditation.  Some of 
these had open comment periods a nd provided full texts, providing an opportunity for feedback from 
other Members. Also, the US had notified OMB Circular A119 and Federal Guidelines on conformity 
assessment principles, with an opportunity to comment, using the commonly used regular 
notification format. The idea was to better track the notification of such measures, which were 
related to the implementation of the Agreement under Article 15.2.   
2.486.   The representative of the European Union  thanked the United States for the proposal as well 
as the clarifications provided. The EU was still reviewing the proposal internally and would revert 
with comments as applicable.  
2.487.   The representative of Colombia  said that her delegation was still reviewing the proposal. The 
proposal was a very good initiative t o boost transparency and better track relevant information. She 
asked for clarification on the link between the new checkbox for Article 15.2 in the regular notification 
format and the reference  to the  G/TBT/2 -series .  
2.488.   The representative of the United States  responded that many Members had issued their 
statements of implementation regarding how they would implement and ensure the operation of the 
Agreement when they first joined the WTO.   For example, the US statement was from 1996 and it 
had not been update d since. However, other Members, including Colombia, had provided updates 
using the G/TBT/2 -series. While it was voluntary, it was very useful to provide information regarding 
new measures which helped operationalize the TBT Agreement. For example, it was very useful to 
provide updates on an any u nderlying laws for conformity assessment, which are key components 
of NQI. Such updates would be notified under the G/TBT/2 -series.  
2.489.   The Secretariat explained that the fastest way to access Members' Article 15.2 statements, 
including any update s provided, was to go to the Fact and Figures – Members' Profiles  section of 
ePing. In terms of document symbol, all Article 15.2 statements were contained in the G/TBT/2 -
series . The very first Article 15.2 notification had been received from the Czech Republic in 1995 
and circulated as G/TBT/2 . From then on, notifications from other Me mbers had been circulated as 
Addenda to this first one.  The ongoing discussions could also allow a revision of this tracking system.  
2.490.   The representative of Australia  said that the proposal had merits and would assist Members 
in meeting their TBT obligatio ns under Article 15.2. His delegation was still reviewing the proposal, 
which was consistent with previous discussions and recommendations as part of the Ninth Triennial 
Review. Australia saw merit in particular in the suggestion to adjust the existing not ification by 
adding a checkbox for Article 15.2 and to use ePing notification submission functions to allow 
Members to notify actions relevant to Article 15.2.  
2.491.   The representative of Canada  said that the proposal was a very useful contribution to the 
impro vement of transparency given that it related to Members' obligation to inform the Committee 
of the measures taken to ensure the implementation and administration of the TBT Agreement. As 
part of the work of the Committee based on the Ninth Triennial Review 's recommendations on 
transparency and as mentioned by Canada in previous meetings of the Transparency Working Group, G/TBT/M/87  
 
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  Canada was working on a proposal regarding the improvement of the current notification format and 
associated guidelines . The aim was to improve the information provided by Members on notified 
measures. Canada  looked forward to the next meeting of the transparency working group so that 
they could further present and discuss their proposal  with other Members.  
2.492.   The representative of Mexico thanked the US for the clarifications provided and  said that her 
delegatio n was still reviewing the proposal. As preliminary remarks, her delegation understood that 
the aim was to have a better tracking system regarding the implementation of the Agreement and 
that adding a checkbox in the regular notification format would not im ply any changes to the 
obligations under the two types of notifications. She also thanked the Secretariat for the clarification 
provided on how to best access Members' statements on ePing, which should make it easier for 
Members to review what has already been provided and identify any updates that should be made. 
The proposal was consistent with the Triennial Review recommendations and Mexico also looked 
forward to having Canada's input on the regular notifications.  
2.493.   The representative of South Africa  thanked the US for their proposal as well as  the useful 
clarifications provided in response to questions.  South Africa was studying the proposal and would 
be submitting any further points for clarity to the US, for further discussion during upcoming 
meetings o r the transparency working group.  
2.494.   The representative of the United Kingdom  thanked the US delegation for the good proposal 
and said that her delegation would be coming back with further comments.  
2.495.   The representative of Brazil thanked the US for their propo sal and recalled that Brazil had 
indeed notified updates to its original Article 15.2 statement and may yet provide further updates 
subsequent to further review. It was very helpful and constructive that the US had tabled the 
proposal so that Members could  reflect and provide further updates regarding domestic practices 
and infrast ructures, towards strengthening and implementing the TBT Agreement.  
2.496.   The Committee took note . 
2.2.1.2.2   Update on the Transparency Working Group  
2.497.   The Chair recalled that  the meetings of this newly established working group were open to 
all delegations and were held in hybrid mode. Its first meeting had been  held on 6 April , following 
which the Chairperson had  circulated a communication on 12 April 2022, with a brief summa ry of 
the meeting and indicating that product coverage in notifications and formats had been identified as 
two priority areas for further discussion. A second meeting , which had originally  been scheduled for 
31 May , had been postponed due to intensive preparations for MC12. He propose d that the next 
session of the working group be held on 13 October. He also encouraged delegations to contact him 
or the Secretariat if they ha d any questions or wish ed to make suggestions regardi ng the work of 
the new working group.  
2.2.1.3   Secretariat update on the ePing SPS&TBT Platform  
2.498.   The Secretariat  recalled that  the new version of the ePing platform had been officially 
launched on Wednesday 13 July , with the participation of senior officials from e Ping partner agencies 
ITC, UNDESA and WTO . She thank ed delegations for their interventions and positive remarks during 
the launch  event, on which a separate document would be circulated . There continue d to be high 
demand for training and outreach activitie s related to ePing , which also came out strongly during 
the transparency thematic session  held earlier in the week . Therefore, the Secretariat would organize  
an ePing information session on the margins of the November Committee meeting, where Members 
could also share their experiences integrating ePing into their domestic outreach mechanisms. At 
the same time, delegations interested in organizing technical assistance and outreach activities on 
ePing at the national level were invited to submit their request s through the ITTC process.  A new 
ePing App was available on smartphones (Android and Apple) , which, for the moment, could be  used 
to receive alerts  and browse notifications. This first basic version ha d been built mainly to help the 
private sector access key updates . Members were encouraged to install and provide feedback on the 
App, which had been developed with significant contributions from ePing partners ITC and UNDESA. 
She also expressed the Secretariat's gratitude and admiration for their colleague L otte Drieghe, who G/TBT/M/87  
 
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  had been a part of the ePing project since its inception and who would be leaving the Secretariat at 
the end of July.  The Committee gave a round of applause for Lotte Drieghe.  
2.499.   The Chair  thanked the three partner agencies for their fruitful collaboration and encourage d 
all delegations take full advantage of ePing to implement and benefit from the TBT transparency 
framework.  
2.500.   The representative of Chile informed the Committee that  they were in the process of 
submitting a technical ass istance request for training on the new ePing platform, possibly to take 
place in early 2023.  
2.501.   The representative of Mexico  thanked the Secretariat for  the excellent  technical assistance 
activity delivered the previous week to government officials and the p rivate sector from Mexico. She 
encouraged other delegations to benefit from such training to make full use of the services of ePing.   
2.2.2   Conformity Assessment Procedures  
2.502.   The Chair  recalled that in the Eighth Triennial Review of the TBT Agreement, the Committe e 
had agreed to develop guidelines to support regulators in the choice and design of conformity 
assessment. And in the Ninth Triennial Review, the Committee noted progress to date and agreed 
to finalize this work. Since the Committee's  last meeting in Marc h, the Committee ha d held two 
informal meetings, on 27 April and 29 June. At the 27 April meeting, Members had provided 
comments on the Elements Paper that was circulated in JOB/TBT/438 . Following this meeting, an 
Aide-Memoire document had been circulated by the Secretariat on 30 May, in JOB/TBT/465 . On 
this basis, a revis ed elements paper was circulated in JOB/TBT/438/Rev.1  on 14 June. At the 29 
June meeting, Members said that the Revised Elements paper was a good basis for further work by 
the Committee  and provided some initial comments on the revised elements paper. The Chair 
opened the floor for discussion.  
2.503.   The representative of the United States  said that comments (JOB/TBT/469 ) had just been 
submitted in writing  and she referred to points made orally at the meeting on 29 June.  
2.504.   The representative of Australia  drew delegations’ attention to their wr itten comments in 
JOB/TBT/470 . The submission summarized comments already conveyed to Members verbally at the 
informal meeting on 29 June. Australia acknowledge d the submissions of other Members and 
thank ed them for their contributions. Australia also sought advice and guidance from the Se cretariat 
on the next steps.  
2.505.   The representative of Brazil , likewise, referred to comments contained in JOB/TBT/471  which 
conveyed what had been said orally at informal discussions. It was stressed that Brazilian  domestic 
policy and practice was broadly  in line  with the revised Elements Paper and , therefore , despite the 
fact that Brazil was not, at this point, submitting more specific points, Brazil confirmed that the 
current revision of the Elements Paper was a good basis  to work on . 
2.506.   The representative of  China  noted that his delegation’s comments ( JOB/TBT/473 ) include d 
some specific suggestions and some questions . China wished to keep communication with all 
Members to establi sh a good guidance for conformity assessment procedures , to support the 
regulators in their design o r selection of conformity assessment procedures. China was open to any 
comments on its suggestions  and comments, or answers to its questions .  
2.507.   The representative of  India suggested that the discussion be kept open for some more time 
to that the Committee could get more views , especially on the most recent submissions.  India’s 
comments were subsequently circulated in JOB/TBT/477 . 
2.508.   The representative of New Zealand  welcome d ongoing effo rts to develop Practical Guidelines 
to Support Regulators in the Choice and Design of Conformity Assessment Procedures  within the 
WTO TBT Committee. New Zealand underline d that New Zealand's arrangements for conformity 
assessment align ed closely with, and in many cases overlapped  with, those of Australia. These 
include d, but were not limited to: (i) shared standards and conformance architecture, exemplified 
by the Joint Accreditation System of Australia and New Zealand (JAS -ANZ) and Food Standards 
Australia  New Zealand (FSANZ); (ii) legislative instruments facilitating conformity assessment, G/TBT/M/87  
 
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  including the Trans -Tasman Mutual Recognition Arrangement (TTMRA) which allow ed products 
approved in one market to be trade d in the other; (iii) a common approach to conducting conformity 
assessment, emerging from broader intersections in institutional design and regulatory policy. New 
Zealand  wished to convey Australia's approach on this basis, as well as in the substantive content 
of their submiss ions to date. New Zealand highlight ed, in particular,  the focus on integrating digital 
technologies and solutions within conformity assessment procedures – shared by the European Union 
among others – which carr ied the significant potential to improve the t ransparency, evidence -based, 
and administrative efficiency of conformity assessment procedures. We would conclude by 
reaffirming New Zealand's support for this important work, looking forward to further opportunities 
to comment and finalizing the document.  
2.509.   The representative of Chinese Taipei  asked Australia, with regards to paragraph 3.7 under 
the sub -section on "Traceability in supply chains", to elaborate on the linkages to risk assessment 
and traceability in supply chains. Considering that there could b e multiple sources of input supply in 
the production process, these inputs could change over time. This could create a significant burden 
for MSMEs to implement a product traceability system. The complexity and costs associated with 
supply chain traceabili ty, their impact on MSMEs, and their effectiveness in enhancing product safety 
needed to be taken into account when choosing and designing conformity assessment procedures. 
For paragraph 3.10 , under subsection "Risk -based: sampling and testing", Chinese Ta ipei suggest ed 
replacing "manufacturers" with "economic operators" which would  cover all stakeholders such as 
manufacturers, importers, distributors , sellers, etc. that play different roles in ensuring the safety 
of products in the market surveillance syst em. For paragraph 3.12 under subsection "Authorities", 
it was proposed to add "importers and/or other responsible economic operators" after "producers"  
in subparagraph  (iii) as the se were responsible for placing the product on the market.  Chinese 
Taipei’s comments were subsequently circulated in JOB/TBT/482 . 
2.510.   The representative of the European Union  expressed appreciation for the continued efforts 
made by the Secretariat to accommodate the several comments raised by Members; this was 
sometimes not an easy task. The European Union provided written comments on the previous 
version of the paper (JOB/TBT/438 ) and also oral comments on 29  June. (Written comments were 
subsequently contained in document JOB/TBT/ 455.) In general, the EU was of the view that the 
document was a sound basis to advance the discussions. One point of particular importance was 
that the  guidelines needed to be practical  and non-binding  but neverthele ss useful for regulators ; 
the EU, therefore, wanted to keep the term  "appropriate and proportionate" .  It was recalled that 
this wording had already been agreed in the Eighth and the Ninth Triennial Review  – so this was a 
matter of consisten cy; it was impo rtant not to take a step backwards. The EU intended to engage 
constructively with all the Members and asked the Chair for an indication of the timeline.  
2.511.   The representative of the United Kingdom  thank ed the Secretariat for their work and drew 
the Committee ’s attention to their comments contained in JOB/TBT/475 .  
2.512.   The representative of the  Philippines  similarly drew the Committee’s attention to its 
comments contained in JOB/TBT/474 . 
2.513.   The representative of Malaysia  noted that their comments were contained in document  
JOB/TBT/472 . Malaysia  was of the view that the paper was a good basis for work on an important 
topic; it was not too technical, practical and easily understandable and  had a clear flow. Three key 
comments were contained in their submission.  
2.514.   The representative of South Africa  thanked the Secretariat for the good work . One issue was 
the term "appropriate and proportionate", which had been  removed in the revised elements paper. 
South Africa  wanted to  understand the reasons why it  had been removed. South Africa  underst ood 
that Members ha d raised comments around those terms, some were for it, and some were against. 
Also, the term "voluntary and mandatory ” for conformity assessment procedures  had been 
introduced, and this needed clarification. Another issue was the reference to "best practices" in 
para. 2.1 – but how would one determine whether an approach was a best practice or not,  what 
were the criteria? The most important  point for South A frica was to understand why, in para. 3.6, 
there was a reference to "moderate risk" with a reference to Annex 1 , while, in Annex 1 , there was 
no explanation  (it contained a discussion of the  types of conformity assessment procedures ). Also, 
in para 3.6, South Africa  had a comment on "accommodating the needs of SMEs"  – it was unclear 
how this would be fully implemented. South Africa would also provide comments on p ara. 3.22 , on G/TBT/M/87  
 
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  "certificates of free sale ". We will provide written comments. ( The c omments  were subsequently 
circulated as JOB/TB T/481 .) 
2.515.   The Chair thank ed all Members for the valuable comments and engagement. In terms of the 
next steps , he said that:  
a. first, since some Members needed additional time to prepare written comments, he 
proposed to extend the deadline until 15 August . Members wishing to provide comments 
on the revised Elements Paper JOB/TBT/438/Rev.1  could do so by that date ;  
b. second, he request ed the Secretariat to prep are an Aide -Memoire document that w ould 
reflect all comments on the revised Elements Paper received by 15  August. This Aide -
Memoire would be circulated by end -August ;  
c. third, he noted that he might hold consultations with some Members to discuss certain 
aspects of the revised paper ; and, based on these comments and consultations, he 
would  ask the Secretariat to prepare, after the summer break, a further revised version 
of the Guidelines ; and,   
d. finally, he noted that he intended to hold an informal meeting o n 13 October to continue 
this work.  
2.2.3   Regulatory Cooperation between Members (MSMEs)  
2.516.   The Moderator126 for the thematic session on Regulatory Cooperation (MSMEs) , held on 12 
July 2022 , provided her report. Her full report is contained in G/TBT/G EN/331 .  
2.517.   The representative of Canada  recalled that the proposal for Thematic Sessions for MSMEs 
had come from Canada in the context of the Ninth Triennial Review. Canada thank ed the Secretariat 
for putting together the session  and Ms Lizano from Costa Ric a for moderating the discussion  – as 
well as all the presenters for their valuable insight s on how Members can help MSMEs navigate the 
various requirements related to technical regulations, standards and conformity assessment 
procedures.  
2.518.   The representativ e of South Africa  noted that there was a lot of important information that 
had been shared at the session and in the moderator's report. One a dditional point that South Africa  
would like to underscore was the point that there was no universal definition of  MSMEs, and MSMEs . 
This term was sometimes defined according to specific objectives or according to sectors. And 
therefore, it was possible that delegations would not be talking about the same companies with 
regards to either employment, number of employee s, or the revenue that they generate d – simply 
because the definition might be different between countries.   
2.2.4   Covid -19 
2.2.4.1   Update from Secretariat  
2.519.   The Chair  recalled the TBT Committee's mandate on COVID -19127, and that the Chairperson 
had asked the Secretariat to prepare a background document on the work of the Committee to date 
since the start of the pandemic.   
2.520.   The Secretariat  present ed the background document, "Overview of Covid19 -related 
Discussions in the TBT Committee" contained in  JOB/TB T/458 . The Secretariat's presentation was 
circulated separately in RD/TBT/367 . 
2.521.   The representative of Brazil  found that the presentation was clear and gave a good picture 
of the measures that Members  had taken within the scope of the TBT Agreement during the 
pandemic . 
 
126 Ms Ana Laura Lizano ( Costa Rica ). 
127 G/TBT/46 , para. 8.4.  G/TBT/M/87  
 
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  2.2.4.2   MC12 outcome on Covid -19 
2.522.   The Chair  drew the Members' attention to one of the MC12 outcome documents that was 
relevant to COVID -19. The "Ministerial Declaration on the WTO Response to the COVID -19 Pandemic 
and Preparedness for Future Pandemics", contained in document WT/MIN(22)/31  provide d some 
important impetus on COVID -19 for the Committee; he drew delegations' attention to paragraphs 
24 and 25 of this document, which reads as follows:  
24. Relevant WTO bodies [which include the TBT Committee] will, within their fields of 
competence, and o n the basis of proposals by Members, continue or initiate work as 
soon as possible, to analyse lessons that have been learned and challenges experienced 
during the COVID -19 pandemic. A stocktaking exercise will be taken of the work by 
WTO bodies under this  declaration yearly at the General Council until the end of 2024, 
based on the reports of those relevant bodies.  
25. Areas of discussion and focus will include, but not be limited to, the topics set forth 
in Paragraph 23 and other topics raised by Members reflecting their varied experiences 
during the COVID -19 pandemic.  
2.523.   The Chair noted that one of the topics of focus mentioned in paragraph 23 document was 
"regulatory cooperation"  and that paragraph 11 deal t with regulatory cooperation in detail:  
11. With a view to expediting access to COVID -19 vaccines, therapeutics, diagnostics 
and other essential medical goods, during COVID -19 and future pandemics, we 
encourage regulatory cooperation, as appropriate, and the sharing of regulatory 
information on a voluntary  basis.  
2.524.   In addition, paragraph 20 provide d some additional areas of relevance to the Committee:  
20. Taking into consideration Members' public health policies and experiences during 
the COVID -19 pandemic, we acknowledge the relevance of further cooperation within 
the mandate of the WTO and its rules to boost post -pandemic recovery and trade flows, 
including on testing requirements and results, recognition of vaccination certificates and 
interoperability and mutual recognition of digital health applications, while continuing 
to protect public health and ensuring privacy and personal data protection.  
2.525.   In this regard, the Chair sought Members ' views on two aspects. First, on substance , the 
Committee  had been mandated to continue its work to analyse lessons that h ave been learned and 
challenges experienced during the COVID -19 pandemic.  In this respect, the Chair  noted that the 
Committee had  already agreed to examine and compile best practices in the context of the 9th 
Triennial Review. Indeed, the Committee ha d been working on this topic, exchanging and discussing 
experiences, as summarized in the earlier presentation by the Secretariat. The Secretariat ha d also 
listed some practices distilled from the discussion and experiences shared by Members, which could 
be helpful to further this work. Thus, the Committee already had a head start  – and this was an 
opportunity to make a meaningful contribution to the WTO's response to the COVID -19 pandemic 
and its preparedness for future pandemics.  
2.526.   Second, on the process , the Chair's sense  was that MC12 had placed additional importance 
on this part of our work. The Committee has been asked to report annually  to the General Council 
on progress until the end of 2024. The Chairman thus suggest ed that the Committee strive to 
continue its work in examining and compiling best practices so that it would be  in a position to 
deliver on this work by 2024. Indeed, standards and regulatory aspects could  end up becoming an 
important contribution to the WTO response to the COVID -19 pandemi c, and the organization's 
preparedness for future pandemics. For the annual reports, the Chair suggested that the Committee 
ask the Secretariat to prepare a draft for the November meeting based on the factual updates that 
the Committee had already been reg ularly provided with by the Secretariat.  
2.2.5   Other Matters  
2.527.   The representative of Colombia  recalled her delegation's interest in the Thematic Session on 
the subject of the regulatory development within the Codex Alimentarius  Commission . Colombia G/TBT/M/87  
 
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  suggested the sharing of national experience s about how different Members ha d participated in the 
different committees of the Codex and the di fferent challenges that they had encountered for 
regulatory development. More generally, being updated on what was going on with the regulatory 
agenda within Codex , and the priorities and the principle/principal elements which were being 
developed for the future  was important . As far as possible, Colombia invited interested Members to 
identify issue s that were directly linked to the TBT Committee being developed with in the Codex 
framework.  
2.528.   The representative of the United States  expressed interest in the topics raised by Colombia 
and was happy to work with them in planning the session.  
3  TECHNICAL COOPERATION ACTIVITIES  
3.1.  The representative of the  United States  drew the Committee's attention to an update contained 
in document G/TBT/GEN/32 9.  
3.2.  The Secretariat  announced that it was launching a new capacity -building  initiative: The 
Transparency Champions programme. It aim ed to scale up the implementation and benefits of the 
TBT transparency framework , and foster "champions" for transparency. Participants would  benefit 
from a six -month programme, involving in -person and virtual modules, as well as ongoing support 
from the Secretariat, mentors and their peers.  The first pilot programme would target offic ials from 
African countries and would start with an in -person workshop in Geneva  from 10 to 14 October 2022. 
The experience gained from this pilot project would guide the Secretariat in rolling out the 
programme in other regions.  
4  OBSERVERS  
4.1  Updates from Ob servers  
4.1.  Updates were provided by ARSO  (G/TBT/GEN/332 ), BIPM (https://www.bipm.org/en/liaison -
partners/wto -tbt), Codex ( G/TBT/GEN/333 ), UNIDO ( G/TBT/GEN/334 ) and ISO ( G/TBT/GEN/335 ).     
4.2  Pending requests  
4.2.  The Chair  noted that an updated list of observers, including pending requests, was contained 
in document G/TBT/GEN/2/Rev.17 . In addition,  he noted that  document RD/TBT/1/Rev.9  provide d 
an updated compilation of the original communications received by the WTO from the various bodies 
that have sought observer status in the TBT Committee and whose requests were still pending.  The 
Chair noted that, regarding the pending request s, that there was no new information  that would 
lead him to believe that the situation ha d changed from where the Committee  had stood at the last 
meeting.  He suggested, therefore, that the Committee revert to this matter when Members had the 
time to further consult among themselves.  
4.3.  The representative of Türkiye  reiterated her delegation's support for the Standards and 
Metrology Institute for Islamic Countries (SMIIC)'s application for observer status in the TBT 
Committee. The SMIIC's app lication to the TBT Committee date d back to 2017. Since then, the 
SMIIC  had maintained its interest on an ongoing basis. During this time, Türkiye had  regularly 
supported its application to the Committee. So far , no progress had been made – and no  concrete  
steps taken. In addition, there appeared to be a lack of recognition of this institution, as well as its 
activities especially considering its significance. SMIIC was an affiliated institution of the 
Organization of Islamic Cooperation (OIC), and, of its 43 members, 33 were also Members of the 
WTO while 8 were observers. The SMIIC aim ed at developing quality infrastructure by establishing 
uniformity in standardization, conformity assessment, accreditation, and metrology activities, thus 
eliminating technic al barriers to trade amongst its Members. In addition, the SMIIC ha d important 
activities in the field of halal, which Türkiye  noted was arising more frequently on the agenda of the 
TBT Committee. SMIIC work ed on the adoption of a single Halal standard and  the establishment of 
a trustworthy  certification system among the OIC countries. With this aim, the SMIIC ha d already 
issued halal standards and provided guideline s for halal certification and accreditation. Türkiye  
believe d that SMIIC's expertise ha d the potential  to support halal trade facilitation. In this respect, 
Türkiye  planned to propose a side event to be organized in order to introduce the mission and 
functions of the SMIIC at the upcoming TBT Committee , in November.  G/TBT/M/87  
 
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  4.4.  The Chair  said that Members need ed to work together to try to find a solution to the matter. 
As Chair, he remained available and would be willing  to meet with interested Members to assist in 
facilitating discussions if this would be helpful. He encourage d Members to continue the consultations 
with each other so that the Committee could have a constructive engagement and resolve  the 
matter .  
4.5.  The representative of the United States  stated that her delegation still object ed to SMIIC 
observer status in the TBT Committee . 
5  OTHER BUS INESS  
5.1.  The Secretariat  recalled that it was organizing a TBT Symposium on 14 October entitled "Global 
supply chains overcoming regulatory bottlenecks". More background and the programme is available 
here.128  
6  DATE OF NEXT MEETING  
6.1.  The Chair recalled that the next meeting of the TBT Committee was scheduled to take place 
from 16  to 18 November 2022. Th e regular  meeting would be preceded by thematic sessions on 
15 November, focusing on good regulatory practice and on standards (standards development in 
Codex).  A Follow -up communication with more dates and information was subsequently circulated 
in ICN/TBT/13 . 
 
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128 https://www.wto.org/english/news_e/events_e/gscforumoct2022_e.htm