RESTRICTED  
  
G/TBT/M/86  
 
24 May 2022 
(22-3961) Page: 1/120 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 9-11 MARCH 2022 
CHAIRPERSON: MRS ELISA MARIA OLMEDA DE ALEJANDRO  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ .......................  1 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................  2 
2.1   Specific Trade Concerns ................................ ................................ .............................  2 
2.1.1   Added and withdrawn concerns  ................................ ................................ ................  2 
2.1.2   New Specific Trade Concerns  ................................ ................................ ...................  5 
2.1.3   Previously raised concerns  ................................ ................................ ....................  19 
2.1.4   Reported progress on STCs  ................................ ................................ .................  112 
2.2   Exchange of Experiences  ................................ ................................ .......................  112 
2.2.1   Transparency  ................................ ................................ ................................ .... 112 
2.2.2   Conformity Assessment Procedures  ................................ ................................ ...... 115 
2.2.3   Other Decisions and Recommendations  ................................ ................................ . 118 
3   TWENTY -SEVENTH ANNUAL REVIEW  ................................ ................................ ...... 118  
4   TECHNICAL COOPERATION ACTIVITIES  ................................ ................................ . 118  
5   OBSERVERS  ................................ ................................ ................................ ............  118  
5.1   Updates  ................................ ................................ ................................ ..............  118 
5.2   Pending Requests  ................................ ................................ ................................ . 119 
6   ELECTION OF CHAIRPERSON  ................................ ................................ ..................  119  
7   OTHER BUSINESS  ................................ ................................ ................................ ... 119  
8   DATE OF NEXT MEETING  ................................ ................................ ........................  120  
 
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/2 2. 
 
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/86  
 
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  2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
2.1.1   Added and w ithdrawn concerns  
2.1.  The representative of Cos ta Rica added STC ID 6082 and STC ID 609.3  
2.2.  The representative of Australia  explained that it withdrew STC number 45  in the Annotated 
draft Agenda (Annex 2 of JOB/TBT/441)4 because Australia chose not to engage with Russia at this 
time. Australia condemned Russia's unprovoked and unjustified attack on Ukraine. Australia said 
that Russia's actions breach international law, the UN Charter and the sovereignty and territorial 
integrity of a neighbouring state. Australia supports Ukraine in opposing Russia's hostilities. Australia 
called on Russia to withdraw its forces from Ukrainian territory and seek a diplomatic solution. 
Australia also supported collective action by the inter national community to impose costs and 
increase leverage on Russia and those in Russia who bear responsibility. Australia also supported 
imposing significant economic sanctions on Russia and Belarus and will continue to support 
international measures to sa nction Russia's behaviour.  
2.3.  The representative of China  reported a good bilateral exchange with the United States, and 
therefore withdrew STC number 2  in the Annotated draft Agenda .5 
2.4.  The representative of the European Union  expres sed the EU and its member States' full 
solidarity with Ukraine and the Ukrainian people. The EU condemn ed in the strongest possible terms 
Russia's unprovoked and unjustified military aggression against Ukraine which grossly violates 
international law and the UN Charter and undermin es international security and stability.  
2.5.  The representative of the Russian Federation  raised a point of order that the EU was  intervening 
outside of the scope of the TBT Committee.  
2.6.  The Chairperson  asked  the EU to finish  their statement,  after which the  Russian delegation 
would  take the floor.  
2.7.  The representative of the European Union  regretted the interruption. The EU demand ed that 
Russia immediately cease its military action, withdraw all its troops from the entire territory of 
Ukraine and fully respect Uk raine's territorial integrity, sovereignty, and independence within its 
internationally recognised borders.  The EU resolutely support ed Ukraine in their own fight of self -
defence and the Ukrainian armed force in defend ing Ukraine 's territorial integrity an d population in 
accordance with Article 51 of the UN Charter.  At all times, the EU said Russia must respect its 
responsibilities under international humanitarian law. Russia also must stop its misinformation 
campaign and cyberattacks. In addition to the st atement made, the EU withdr ew all STCs against 
Russia.6 
2.8.  The representative of the Russian Federation  called on Members to refrain from interventions 
on issues and events which are outside the scope of the TBT Committee and the WTO itself and 
within the focus of other international organizations and diplomatic agencies.  
 
2 Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -2010: General 
specifications for the labelling of pre -packed food and non -alcoholic beverages (ID 608)  
3 Colombia - Food Prioritized for its Sodium Content, Certification Requirements (ID 609).  
4 Russian Federation - Federal Law n° 468 on wine making and wine growing in the Russian Federation 
(ID 650).  
5 United States - Trade regulation rule on care labelling  of textile wearing apparel and certain piece 
goods.  
6 Russian Federation - Federal Law n° 468 on wine making and wine growing in the Russian Federation 
(ID 650), Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety (published on 24 Oct ober 
2011) (ID 332), Russian Federation - Rules of cement certification (ID 497), and Russian Federation - Federal 
law No 487 -FZ, providing a framework for comprehensive use of special labelling and traceability of goods and 
Decision No. 792 -r specifying t he goods to which labelling will apply and the dates of introduction of the 
mandatory labelling (ID 567).  G/TBT/M/86  
 
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  2.9.  The representative of the United Kingdom  said Russia's assault on Ukraine was an unprovoked 
premeditated attack against a sovereign democratic state and a fellow Member of this organization. 
The United Kingdom  and its international partners stand united in condemning the Russian 
Government's repre hensible actions which are an egregious violation of international law and the 
UN Charter. The United Kingdom  said that as permanent member of the UN Security Council, Russia 
has a particular responsibility to uphold international peace and security. Inste ad, Russia was 
violating the borders of another country and its actions are causing widespread suffering. The 
Russian government has shown that it was never serious about engaging in diplomacy, and it 
deliberately worked to mislead the world in order to ma sk its carefully planned aggression. The 
United Kingdom  said that Russia must urgently de -escalate and withdraw its troops. Russia must be 
held accountable and stop undermining democracy, global stability and international law.  
2.10.  The representative of the United States  reiterated its strong support for Ukraine during this 
unimaginably difficult time. The United States paid tribute to the heroism of the Ukrainian people, 
their armed forces and their leaders. The United States also expressed its appreciation to  the many 
Members around the globe which are taking action in cooperation and coordination with the United 
States. Our important work together will continue. United States condemned Russia's pre -meditated 
and unprovoked attack on Ukraine and the United Sta tes equally condemned Belarus' regime for 
aiding Russia's war of aggression. President Putin's premeditated war has brought catastrophic loss 
of life and human suffering. Russia was solely responsible for the death and destruction and the 
world must hold R ussia accountable. Russia's actions constituted a clear violation of Article 2.4 of 
the United Nations Charter which states that all member states shall refrain in international relations 
from the threat or use of force against the territorial integrity or  political independence of any state. 
The United States called upon Russia to immediately cease its use of force against Ukraine and 
refrain from any further unlawful threat or use of force against any UN member state. The United 
States was united with its  allies and partners in our commitment to ensure the Russian Government 
pay the severe economic and diplomatic price for its further invasion of Ukraine. Our work at the 
WTO focuses on trade but the Organization cannot be neutral to the struggle at hand. T he WTO was 
predicated on certain values, among these that a fair and just international order is one built on 
rules not power, on reciprocity not predation and on transparency not perfidy. The United States 
said the actions of Russia are incompatible with the rules -based system we have built and worked 
to improve. The United States added that it had intended to support STC number 45  in the Annotated 
draft Agenda7, but was withdrawing all STCs against Russia.  
2.11.  The representative of Canada  strongly condemn ed Russia's unjustifiable and unprovoked 
invasion of Ukraine. Canada said t he attacks are causing widespread humanitarian consequences 
and resulting in the senseless death of innocent people. The international community must be seized 
of this issue. This was not just an attack on Ukraine. This was an attack on international law, 
including the UN Charter as well as democracy, freedom and human rights. Canada withdrew  support 
for STC number 47  in the Annotated draft Agenda 8 and instead support ed STC number 53  in the 
Annotated draft Agenda9. 
2.12.  The representative of Japan  echoed the previous statements regarding the situation in 
Ukraine. Japan believe d this was  very much relevant  to this Committee and to the WTO in terms of 
consistency with international law. Japa n was seriously concerned about the situation in Ukraine and 
said that it constitutes the infringement of a WTO Member' s sovereign rights and territorial integrity , 
and is a violation of international law. It is totally unacceptable, and Japan strongly condemn ed it. 
Japan join ed the international community to deal with the situation by standing alongside with 
Ukraine and its people.  
2.13.  The representative of Ukraine  noted the concern and reaction of one Member. Russia  stated 
that because WTO is a tr ade-related organization , Ukraine and other WTO Members should refrain 
from politization of this institution and instead engage constructively in substantive dialogue. We 
believe that by undue politization Russia  meant avoiding reference in this forum to t he military 
invasion and aggressive full -scale war launched against Ukraine 14 days ago. The attacks which 
jeopardized the very ability of Ukraine  to participate in substantive dialogue referred to by Russia, 
 
7 Russian Federation - Federal Law n° 468 on wine making and wine growing in the Russian Federation 
(ID 650).  
8 Indonesia - Government Regulation 28 o f 2021 – Implementing Regulation (for the 
Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act" (ID 724) . 
9 Indonesia - Halal Product Assurance Law No. 33 of 2014 and its implementing regulations (ID 502).  G/TBT/M/86  
 
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  as our infrastructure suffers constant attacks,  and as our experts are either hiding in bomb shelters 
or are forced to flee their homes along with 2 million of Ukrainians and other foreign citizens present 
on the territory of Ukraine.  
2.14.  Ukraine  thank ed those Members who spoke today and during other commi ttee meetings. 
Ukraine was  very grateful to all Members who have stood with Ukraine in these terrifying times and 
have adopted or are in the process of adopting strong economic sanctions against the Russian 
Federation. Ukraine  also thank ed the Developed Co untries Coordinating Group which recently 
excluded the Russian Federation from its deliberations. Ukraine  called on other WTO Members not 
to remain indifferent in the face of this unprecedented and illegal aggression of the Russian 
Federation. Given that t he Russian Federation has clearly violated  the basic principles and values 
that the GATT and the WTO have promoted for almost 80 years since the end of World War II, 
Ukraine  urged Members to consider whether the Russian Federation's continued participation  in this 
organization, including this and other WTO meetings, would be consistent with the objective and 
purpose of the WTO. Ukraine d id not see how Members can conduct economic relations with the 
Russian Federation within the WTO on a business -as-usual ba sis in the presence of these awful 
circumstances.  
2.15.  The representative of Switzerland  echoed the statements made by previous speakers on the 
situation in Ukraine. Switzerland condemn ed the Russian military attack on Ukraine in the strongest 
possible terms. T his attack constitute d a violation of the territorial integrity and sovereignty of 
Ukraine as well as a violation of international law , in particular of the UN Charter. Switzerland call ed 
on Russia to respect its international obligations and to reverse it s actions as well as to withdraw its 
troops and contribute to de-escalation. Switzerland call ed on all actors to respect international law 
including international humanitarian law.  
2.16.  The representative of New Zealand  joined other Members  who have made statem ents on 
Ukraine and Russia. New Zealand  extend ed its  full support to our colleague present  from Ukraine . 
We must recognize that international trade has been greatly impacted by the conflict , and it was not 
irrelevant. New Zealand strongly condemn ed Russia's unjustifiable and unprovoked invasion of 
Ukraine. Russia's action breache d international law and the sove reignty and territorial integrity of a 
neighbouring state. New Zealand strongly support ed Ukraine in opposing the Russian assault. The 
attacks were causing widespread humanitarian consequences and resulting in the senseless deaths 
of innocent people. New Z ealand support ed collective action by the international community to 
impose costs on Russia and those in Russia who bear responsibility.  
2.17.  The representative of the Republic of Korea  backed  the previous speakers on the situation in 
Ukraine. The Korean Govern ment strongly condemn ed Russia's armed invasion against Ukraine as 
a violation of principles of the UN Charter. The use of force that cause d innocent casualties cannot 
be justified under any circumstances. Ukraine's sovereignty and territorial integrity an d political 
independence must be respected. In connection with this, Korea withdrew STC  numbers  1010 and 
33 in the Annotated draft Agenda11 against Russia.  
2.18.  The representative of the Russian Federation  said d iscussion of events in Ukraine in the TBT 
Committ ee was senseless and counterproductive  from its point of view. Given this , Russia  refrain ed 
from comments on the issue. Russia said its stance was set forth in public statements of the Russia n 
government  and the Minister of Foreign Affairs as well as in Ru ssia's statements during the meetings 
of UN Security Council, UN General Assembly, High Commission of Human Rights as well as other 
relevant international fora. Russia said that i n numerous international platforms, WTO Members 
repeatedly expressed their co mmitments to strengthen multilateralism and support rules -based non -
discriminatory and transparent multilateral trading system with the WTO at its core. Russia regr etted 
that the efforts of certain Members was contributing to  fragmentation of the multilate ral trading 
system , instead of engaging constructively in a substantive dialogue on the key issues of the global 
trade agenda. On the contrary, all Members need ed to combine their efforts to improve the WTO's 
function  and demonstrate its continued relevanc e for international trade.  
2.19.  The representative of Turkey  consider ed the ongoing aggression against Ukraine 
unacceptable. Turkey  called for immediate cessation of military operations and withdraw al of all 
 
10 Russian Federation - Proce dure for the Import of Products Subject to Mandatory Conformity 
Assessment into the Customs Territory of the EAEU (Decision No. 130, 2021)  
11 Russian Federation - On Safety of Wheeled Vehicles (TR CU 018/2011) (ID 687).  G/TBT/M/86  
 
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  forces from Ukraine. The humanitarian crisis should be stopped immediately. Turkey  reiterate d its 
call for an urgent humanitarian response, dialogue, and diplomacy. Turkey said its  firm support for 
the unity, sovereignty and territorial integrity of Ukrain e will continue.  
2.1.2   New Specific Trade Concerns  
2.1.2.1   Malaysia - Guideline for Approval of Electrical Equipment (Electricity Regulation 
1994) Information Booklet 2018 Edition (GP/ST/N0.14/2017), G/TBT/N/MYS/90  (ID 
72912) 
2.20.  The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates this opportunity to provide our comments regarding Malaysia's "Guideline for 
Approval of Electrical Equipment (Electricity Regulation 1994) Information Booklet 2018 Edition", 
notified to the WTO Members on 11 June 2019 as G/TBT/N/MYS/90 , and in force since 1 February 
2021. Korea fully res pects and supports Malaysia's efforts to introduce energy efficiency regulation 
for the safety of its people and the protection of the environment. And we sincerely appreciate your 
official reply on 29 October 2021 to our enquiry regarding the said regulat ion. The reply from the 
Malaysian Energy Commission (EC) stated that there is no need to renew the QR code on the energy 
efficiency label every year under the current regulations, but the local situation is understood to be 
different. Therefore, we request  Malaysia to confirm the alignment between the relevant regulation 
and their actual application. The regulation requires "importers/manufacturers to include a QR code 
in the energy efficiency label (the star rating sticker) so that, by scanning the QR code , consumers 
can check the product certification information, including the expiry date of Certificate of Approval 
(COA), from the Malaysian Energy Commission website". As a COA is valid for a year, certification 
must be renewed annually, and the QR code fr om the renewed COA must be attached to the product.  
2.21.  In this regard, the QR code also gets changed at the certification renewal, which causes a 
problem of having to replace the label every year. This adds to the manufacturer's burden in cost 
and time for di scarding the old labels, and printing and reattaching the new ones. In addition, 
scanning an old QR code that has not been renewed will show an expired certificate for the product, 
which may cause confusion to consumers. To resolve these difficulties, Kore a submitted an enquiry 
on 10 May last year, requesting Malaysia to improve the regulation, and we received a reply from 
Malaysia clarifying that "importers or manufacturers are not required to change the QR code in the 
energy efficiency label for every COA  renewal of household electrical appliances". However, we have 
later found that (i) a new QR code different from the previous one was issued and (ii) scanning the 
previous QR code on the existing label directs the user to the EC website that only shows the  old 
and expired COA information, as a result of certification renewal by a local company in Malaysia in 
early January this year. Therefore, Korea once again requests that Malaysia re -confirm the relevant 
regulation and the actual COA renewal process. Many  countries such as the European Union, China, 
and the United Arab Emirates, do not require changing QR codes in energy efficiency labels every 
time the certification is renewed. In line with this international practice, Korea reiterates its request 
that Ma laysia revises its regulation to require updating only the information on the website accessible 
via the QR code, instead of changing the QR code, at the renewal of COA.  
2.22.  In response, the representative of Malaysia  provided the following statement. We would  also 
like to thank the Republic of Korea for submitting enquiries pertaining to the said regulation through 
our WTO TBT Enquiry Point in May and October last year, in which Malaysia has responded. Malaysia 
takes note of the Republic of Korea's concern reg arding the implementation of the QR code as 
stipulated under the guideline. In this regard, Malaysia would like to reaffirm that provisions of the 
guideline are in place. We are currently in close consultations with the Energy Commission of 
Malaysia to stu dy the issues raised by the Republic of Korea. Meanwhile, Malaysia would like to seek 
the Republic of Korea's understanding in this matter, and we look forward to further engaging with 
Republic of Korea bilaterally to address their concerns.  
2.1.2.2   Mongolia - Draft Law on controlling the circulation of alcohol beverages, and fight 
against alcoholism, G/TBT/N/MNG/14  (ID 73013) 
2.23.  The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Draft Law on controlling the circulation of alcohol beverages, and  fight against 
 
12 For previous statements follow the thread under ID 729 . 
13 For previous statements follow the thread under ID 730 . G/TBT/M/86  
 
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  alcoholism, notified to the Members of this Committee by the Government of Mongolia on 
12 August  2021 in document G/TBT/N/MNG/14 . The notified measure contains provisions of concern 
to Mexican exporters in the alcoholic beverage industry as it bans sales of such produc ts through 
electronic channels. While Mexico respects Mongolia's aim, we believe that this ban, far from 
contributing to reducing the harmful use of alcohol, limits the ability to control and trace lawful sales 
of alcoholic drinks, thereby promoting illega l distribution channels or suspect products. In addition, 
it is important to emphasize that this ban takes place in a context where, owing to the health 
emergency caused by COVID -19, online sales provide an alternative means of buying and selling 
products,  suited to isolation and social distancing.  Another of the Draft Law's provisions of concern 
is its ban on alcoholic drinks with an alcohol content greater than 35% alcohol/volume, which will 
have a direct impact on Mexican exports of drinks such as mezcal  and tequila, both of which exceed 
that percentage. It should be noted that, if the aim is to reduce the harmful use of alcohol, the ban 
on alcoholic drinks with an alcohol/volume percentage above 35% will not contribute to achieving 
this goal, as the exce ssive consumption of drinks with a low alcohol content also represents a threat 
to consumer health.  
2.24.  On the other hand, branding -related restrictions are also of concern to Mexican exporters, as 
branding is an international practice intended to inform the c onsumer of the quality of the products 
they are purchasing, their reputation and the potential consequences of their misuse.  In light of this, 
the Mexican delegation requests that the delegation of Mongolia, in view of the commitments in 
Articles 2.2 and 2 .4 of the TBT Agreement, share information on the alternatives studied prior to the 
determination of the requirements in the Law and on how these requirements constitute less 
restrictive alternatives in view of the legitimate objective that Mongolia seeks to achieve. We would 
also like information on the international standards used as a basis for developing this measure.  In 
addition, we request that the delegation of Mongolia share information about the following steps and 
confirm the date of the measure's  entry into force. If this measure entered into force on 
1 January  2022, as established in the notification circulated to WTO Members, Mongolia would be in 
breach of the commitment to grant a reasonable interval of not less than six months, as established 
in paragraph 5.2 of the Ministerial Decision on Implementation -related Issues and Concerns, adopted 
by WTO Members on 20  November  2001.  The delegation of Mexico thanks the delegation of Mongolia 
for giving its consideration to this statement and reiterates  its availability to attend bilateral meetings 
that will allow our concerns on this issue to be addressed.  
2.25.  In response, the representative  of Mongolia  provided the following statement. Mongolia 
thanks Mexico for bilateral trade interest with Mongolia. We take note of the questions raised by the 
delegation of Mexico. We have forwarded them to the capital and will be replying through bilateral 
meetings as  well as TBT eAgenda.  
2.1.2.3   United States - Energy conservation program: test procedure for circulator 
pumps, G/TBT/N/USA/1815  (ID 73114) 
2.26.  The representative of China  provided the following statement. Firstly, the US did not reply to 
China's question "Do small vertical pipeline pumps i nclude end suction close coupled (ESCC) pumps 
that can be used vertically ". An end suction close coupled pump also meets the definition of a small 
vertical in -line pump by the Circulator Pump Working Group (CPWG) when it is vertically use. Unclear 
definiti ons of small vertical in -line pumps may create unnecessary trade barriers. It is recommended 
that the US clarifies "whether the small vertical in -line pumps include end suction close coupled 
pumps (ESCC) or not ". Secondly, China suggests that US adds schem atic diagrams to help 
understand the definitions of "mechanically -coupled pumps " and "close-pumps ", so as to avoid 
misunderstandings. Thirdly, for pressure control type circulator pumps, the US has given an equation 
for PERCIRC but has not yet provided sci entific evidence for the PERCIRC weighting assignments, 
which may create unnecessary trade barriers. China suggests that the US provide scientific evidence 
for PERCIRC weighting assignments to pressure control type circulator pumps. Fourthly, a n 
"integrate d design pump " means a pump with associated piping and accessories from which the 
individual pumps cannot be easily separated. China suggests that the US clarifies the efficiency 
testing method for this type of pump.  
2.27.  In response, the representative of the United States  provided the following statement. I just 
would like to note that we have not received any comments to the US Enquiry Point on 
G/TBT/N/USA/1815  from China, and the first time we are hearing about these concerns are on the 
 
14 For previous statements follow the thread under ID 731 . G/TBT/M/86  
 
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  floor of the TBT Committee. We really do enco urage China to submit comments through the US 
Enquiry Point in advance by the deadline that is provided in the notification so that we can answer 
the technical concerns that you have. If you bring them here without any advance warning we really 
are not abl e to answer the technical questions or respond in any way that is substantive. So I will 
note here that the Department of Energy draft regulation to the TBT Committee was notified in 
G/TBT/N/USA/1815 , and the comment period closed on 18 February 2022. We did not receive any 
comme nt 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 Procedures for Circulato r Pumps.  
2.1.2.4   Kingdom of Saudi Arabia - Corporate average fuel economy standard (SAUDI 
CAFE) for all light duty vehicles, G/TBT/N/SAU/1226  (ID 73215) 
2.28.  The representative of China  provided the following statement. 1. It is recommended to add 
the conversion method of WLTC. 2. For new ene rgy vehicles as PHEV and BEV, it is recommended 
to introduce NEDC and WLTC, and add testing methods according to relative UN regulations, and 
put forward targeted energy consumption requirements. 3. For derogation of companies with annual 
global sales of n o more than 10,000 vehicles, it is recommended to change the sales requirements 
to "companies whose annual sales volume in Saudi Arabia does not exceed 10,000 (or a smaller 
number). 4. To fully realize the CAFE target, it is suggested to accelerate the con struction of new 
energy infrastructure, develop subsidy policies for new energy vehicles, encourage and support a 
rapid development of new energy vehicle industry, and gradually implement the 3rd phase fuel 
consumption policy according to the development o f new energy infrastructure.  
2.29.  In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. We take note of the concerns raised and we will convey them to the capital and reply in 
due course. A technical statement was circ ulated following the meeting.16 
2.1.2.5   South Africa - Regulations relating to the composition, production and labelling 
of wine and spirits intended for sale in the Republic of South Africa, 
G/TBT/N/ZAF/48/Rev.2/Add.1  (ID 73317) 
2.30.  The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to 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 M embers of this Committee on 
20 December  2021 in document G/TBT/N/ZAF/48/Rev.2/Add.1 . First of all, we would like to thank 
the Government of South Africa for the opportunity to provide comments during the public 
consultation that concluded on 12  February  2022. Both the industry and the Government of Mexico 
participated in this process to share concerns about what we believe could have an impact on 
Mexican exporters of tequila and mezcal, as well as on potential exporters of raicilla and bacanora.  
Although South Africa has already responded to the comments submitted by Mexican industry, there 
has not yet been a response to the comments submitted by the Government of Mexico. Could the 
delegation of South Africa let us know when this response is likely to be issued?  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 through which we could request a 
bilateral meeting, if necessary.  The delegation  of Mexico thanks the delegation of South Africa for 
giving its consideration to this statement and reiterates its thanks for the transparency in the 
amendment of these Regulations.  
2.31.  The representative of the European Union  provided the following statement.  The EU thanks 
South Africa for notifying their proposed revisions to their alcohol beverage composition, production, 
and labelling regulations on 12 December 2021. The EU sent written comments on 16 February. Our 
key concerns relate to the following categ ories: spirit aperitif, gin, description of pot still brandy and 
vintage brandy. In addition, we suggested the creation of a new category called "spirit drink" for 
products that do not fall under other categories due to their alcohol content. We look forwa rd to 
receiving written replies from South Africa to our detailed written comments.  
 
15 For previous statements follow the thread under ID 732 . 
16 G/TBT/W/7 71. 
17 For previous statements follow the thread under ID 733 . G/TBT/M/86  
 
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  2.32.  The representative of the United States  provided the following statement. The United States 
thanks South Africa for notifying their proposed revisions to their alcohol beve rage composition, 
production, and labelling regulations on 12 December 2021. The US appreciates South Africa's 
prompt response to our comments submitted on 11 February 2022. The United States encourages 
South Africa to address our concerns with regard to h ow flavoured spirit products will be classified 
if they have an alcohol content of over 30% but less than the alcohol content required to be classified 
under the specific spirit category, for example, 43% alcohol by volume (abv) for whiskey. The United 
States is concerned that this measure would unnecessarily restrict imports of certain US flavoured 
spirits that contain between 30% and 43% alcohol by volume. We look forward to continued 
engagement with South Africa to address these concerns and ensure trade  of US flavoured spirits is 
not unnecessarily disrupted.  
2.33.  In response, the representative of South Africa  provided the following statement. South Africa 
thanks Mexico for the interest shown and questions/concerns shared with us regarding the 
notification to  the WTO of the proposed amendment to the Draft Regulations Governing the 
Composition, Production and Labelling of Wine and Spirits Intended for Sale in the Republic of South 
Africa. We also thank the EU and the US for their question and comments in that r egard. The 
document number for the notification is G/TBT/N/ZAF/48/Rev.2/Add.1  circulated on 17 December 
2021. According to our records, South Africa received only one set of comments from Mexico through 
our National TBT Enquiry Point - the SABS - regarding the  possible effects that the draft regulation 
could have on the marketing of Tequila, Mezcal, Bacanora and Raicilla, 100% agave beverages. 
These comments related to Technical Barriers to Trade (TBT) as well as Intellectual Property (IP) 
elements within the d raft regulation. South Africa responded to all the concerns raised by Mexico 
through a formal letter dated 15 February 2022. We also have now taken note of the statement by 
the EU and the US in support of the STC raised by Mexico. South Africa remains avai lable to engage 
with Members to provide further clarifications and address any questions and concerns. We believe 
the issues raised could indeed be resolved through a bilateral engagement. Should Members 
concerned wish to request a bilateral meeting, our S outh African Permanent Mission in Geneva can 
be contacted to facilitate such engagements.  
2.1.2.6   European Union - Specific test procedures and technical requirements for the 
type-approval of motor vehicles with regard to their event data recorder and for the type -
approval of those systems as separate technical units, G/TBT/N/EU/838 , 
G/TBT/N/EU/871  (ID 73418) 
2.34.  The representative of China  provided the followi ng statement. 1. Article 2 and Article 3 
stipulate that vehicle type approval shall comply with "UN Regulation No 155 Uniform provisions 
concerning the approval of vehicles with regards to cyber security and cyber security management 
system ", but this arti cle does not indicate how to prove the compliance. Therefore, China suggests 
that this part should be revised to "The crash -related data that the EDR records and stores shall be 
protected against manipulation, which shall be justified by complying UN R155 ", which means if the 
motor vehicle has obtained type approval according to UN R 155, it shall be deemed as complying 
with the requirements of Article 3. 2. For the transitional period, Article 2 adopts technical 
requirements from UN R 160 Chapter 5. Accord ing to the provisions of 11.3 in UN R 160, the 
transitional period for type approval is before 1 July 2026, whereas the EU will enforce UN R 160 on 
6 July 2022. We recommend that the regulation be consistent with the implementation transitional 
period spec ified in article 11.3 of UN R160. (Article 11.3 of UN R160: Until 1 July 2026, Contracting 
parties applying this Regulation shall accept type approvals to the original version of this Regulation, 
first issued before 1 July 2024.)  
2.35.  In response, the represent ative of the European Union  provided the following statement. The 
EU would like to note that that the notified draft was notified under reference number 
G/TBT/N/EU/838  in accordance with the TBT Agreement on 27 September 2021 with a 60 -day 
commenting period. China submitted comments on 26 November 2021. The EU has prepared the 
following reply to those comments. With regard to Article 2 of the notified draft, the Chinese 
authorities recommended that information documents and approval marks, including for Separate 
Technical Units, shoul d be added to the notified draft or added to Regulation (EU) 2020/683. The EU 
would like to clarify that the process of revising Regulation (EU) 2020/683 is ongoing and those 
amendments will be adopted before the date on which the requirements of notified draft will become 
applicable (6 July 2022). The TBT consultation of this revision was launched on 8 February 2022 
 
18 For previous statements follow the thread under ID 734 . G/TBT/M/86  
 
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  under reference number G/TBT/N/EU/871  and the commenting period will expire on 9 April 2022. 
With regard to Article 3, China recommended specific wording. China explains that they understand 
the intention of this provision as to provide that the motor vehicle shall be deemed to comply with 
the requirements of Article 3 if it has been type -approved according to UN Regulation No. 155. 
However, the EU considers that such purp ose is best achieved by the present text. In this regard, 
Article 3 establishes a presumption that material compliance with UN Regulation No. 155 would 
result in compliance with the obligation to protect the data against manipulation.  
2.36.  Finally, regarding Ch ina's observations on the 01 Series of Amendments to UN Regulation 
No 160, the EU would like to clarify that only the 01 Series of Amendments meet the requirements 
laid down in Regulation (EU) 2019/2144 of the European Parliament and of the Council (Genera l 
Safety Regulation or GSR), which is the basic act for the notified draft on Event Data Recorders. The 
GSR requires the detailed technical requirements and test procedures for EDR to become applicable 
on 6 July 2022. The notified draft must comply with th e GSR, as this is the basis on which it is being 
adopted. Therefore, it must provide for the application of the 01 Series of Amendments as from the 
aforementioned date. The revised draft takes into account the obligations of the EU and of the EU 
member Sta tes under the 1958 Agreement, providing that approvals in accordance with UN 
Regulation 160 granted outside the EU shall be accepted as an alternative to an approval in 
accordance with 01 Series of Amendments to UN Regulation No 160, for the purposes of gr anting 
an EU approval, as well as registration, sale and entry into service until, respectively, 1 July 2024 
and 1 July 2026.  
2.1.2.7   Canada - Pest control products regulations (ultraviolet radiation -emitting devices 
and ozone -generating devices), G/TBT/N/CAN/656  (ID 73519) 
2.37.  The representative of China  provided the following statement. China suggests that Canada 
adds "for such products, the certification of the exporting country meeting relevant standards can 
be accepted and recognized" in its amendment, which not only ensures the safety and reliability of 
products but also makes benefits for enterprises, avoiding technical barriers to trade.  
2.38.  In response, the representative of Canada  provided the following statement. UV radiation -
emitting and ozone -generating devices that make c laims to control or kill bacteria and viruses on 
surfaces, objects, in water, and in the air are more widely and increasingly available for sale in 
Canada since the pandemic. Health Canada has not yet received sufficient evidence to demonstrate 
that all UV  and ozone -generating devices can be used safely or work as claimed. On 7 June 2021, 
Canada's Minister of Health enacted an Interim Order under the Pest Control Products Act to address 
significant risks to human health and safety posed by these devices. As  the Interim Order expires 7 
June 2022, Canada is proposing amendments to the Pest Control Products Regulations to continue 
the health and safety protections established under the Interim Order, with some changes. The 
proposed amendments subject certain UV  radiation -emitting and ozone -generating devices to the 
Pest Control Products Act and its Regulations. These devices require registration under the Act 
through Canada's existing submission review process unless they meet specified conditions. If they 
meet those conditions, the device is authorized to be imported, manufactured, sold and used in 
Canada. The conditions for authorization in question are intended to protect human health and 
safety. Electrical safety certification, by a body accredited by the Sta ndards Council of Canada, is 
one of these conditions, and ensures that there are no hazards, such as fire and electrical shock, 
posed by the devices in question. These provisions reflect similar existing Canadian federal and 
provincial laws on device safet y. 
2.39.  Canada is committed to its obligations under the WTO Agreement on Technical Barriers to 
Trade, including the non -discrimination obligation. The proposed regulatory amendments accord the 
same treatment to both domestic suppliers in Canada and suppliers f rom other WTO Members. Any 
organization from a WTO Member dedicated to electrical safety certification can apply to be 
accredited by the Standards Council of Canada. The requirements for accreditation and the standards 
that accredited organizations certify  are the same regardless of country of origin. Accredited 
organizations, including international organizations, can complete the certification work in the 
countries exporting their devices to Canada. It is our understanding that one North American 
organiza tion accredited in Canada has an affiliate in China and may comply with the certification 
 
19 For previous statements follow the thread under ID 735 . G/TBT/M/86  
 
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  requirement proposed in the regulatory amendments. Canada would be pleased to share the name 
of this organization separately with the Chinese delegation.  
2.1.2.8   European Uni on - Proposal for a regulation of the European Parliament and the 
Council laying down harmonised rules on artificial intelligence (Artificial intelligence act) 
and amending certain union legislative acts (ID 73620) 
2.40.  The representative of China  provided the following statement. We support EU to regulate 
artificial intelligence, however, in order not to create 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 definition as to "artificial intelligence 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 which as artificial intelligence. Secondly, the 
expansion of the scope of definition as to AI would also expand the scope of high -risk AI enterprises, 
which  would result in that the enterprises covered in this regulation would be much more than the 
10% expected by the European Commission, greatly increasing the burden of enterprises and 
regulator, which is inconsistent with the legislative purpose of the EU.  
2.41.  2. It is suggested to lay down relevant classification guidance of prohibited artificial 
intelligence referred to in article 5 (1). The wording "prohibited artificial intelligence practices " uses 
vague and subjective phrases such as "subliminal techniques ", "beyond a person's consciousness ", 
"materially distorting a person's behaviour ", etc. For providers, to judge which applications or 
technologies constitute "unacceptable risks " by those phrases would bring significant compliance 
risks. It is suggested to  provide a more precise definition or a limited negative list. 3. It is suggested 
to eliminate the requirement of "Free of errors and complete " in article 10 (3). If not, please further 
clarify the definition. The new data would be generated in AI training  and testing, and the datasets 
would be enriched after placing on the market. Few datasets could comply with the "free of errors 
and complete ", which is inconsistent with the current state and development of the AI industry. The 
act regulates AI systems fr om the angle of traditional products without considering the dynamic 
characteristics of the life cycle of machine learning systems development. Therefore, it is suggested 
to eliminate this requirement. If not, please further clarify the definition.  
2.42.  4. It i s suggested to eliminate 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 is not directly and necessarily rel ated to assessing the 
requirements set out in Chapter 2, Title III. Firstly, the explainable AI is still at the forefront of 
research, even AI system developers cannot "fully understand " AI systems, that is, providing the 
source code cannot necessarily mee t the needs that market supervision departments assess whether 
AI systems conform to requirements. Secondly, providing source code could not prevent AI system 
errors. The source code assessment could not replace the systematic verification and actual testi ng; 
the latter is more direct and effective in identifying or correcting harmful results and verifying 
whether the AI system is in line with its design. Finally, the obligatory provision of source code also 
deviates from the common international practices of protecting source code as a commercial secret. 
5.It is suggested that, to protect all data information from providers, confidentiality obligation for 
the Commission, the member States and their market surveillance authority, notified bodies and 
other pa rticipating bodies should be emphasized and specified in article 70. In this act, AI providers 
are required to provide a large number of data -sets and technical documents. Therefore, the EU 
shall strengthen the controls on data information security in some  respects.  
2.43.  6. It is suggested to keep Penalties in article 71 consistent 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 inf ringement of the provisions of this Regulation ". 
If in this act the penalties are not regulated by member States as the above, it is suggested to revise 
the calculation measures of the penalties in article 71, and reassess the fines, to make sure the 
penal ties are proportionate 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 to the non -compliance (under C hapter 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. 7. It is suggested to add applicable 
 
20 For previous stateme nts follow the thread under ID 736 . G/TBT/M/86  
 
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  transition perio d for 48 months in Chapter 2 . The presumption of conformity shall be carried out by 
the provider after the publication of the harmonized standards. It usually takes more than 36 months 
for standards bodies to lay down new standards, and another 12 months i s needed to adjust products 
and systems, conduct conformity assessments and prepare all required documentation.  
2.44.  In response, the representative of the European Union  provided the following statement. We 
are currently preparing written replies to your writt en comments. Let me react to some key issues 
raised by you today. As regards the definition of artificial intelligence (AI), we aimed to adopt a 
definition as technology neutral as possible so it can be applied over time to innovation and market 
developmen ts. The proposal builds on the internationally recognised definition of 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 certainty to 
operators and supports the dynamic character of the overall definition, insofar as the European 
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 certain system to be classified as AI for 
the purpose of the AI Act, it is not enough that any of the techniques in Annex I is used, but the 
system must also fulfil the "functional" definition in Article 3(1). While the prohibitio ns in Article 5 
use abstract formulations to cover a variety of use cases of harmful practices, these concepts are 
not new to Union law and they have already been used in court case law and other Union legal acts. 
As appropriate, the European Commission ma y issue guidelines on these concepts, including 
illustrative examples of practices that could be covered.  
2.45.  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 risk management, 
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 9(4)). To avoid any doubts, further clarification in this sense may also 
be made i n Article 10 (a point already considered by the Council of the European Union). The 
proposal clearly protects the source code as intellectual property (see Article 70(1)a.). On that basis, 
Article 64(2) makes the access to source code dependent on two stri ct 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 Title III, Chapter 2 of the  AI Regulation. This strikes a balance between intellectual property 
rights protection and safety protection to safeguard important public interests, in line with our 
international agreements and commitments. Article 70 also requires national competent aut horities 
and notified bodies involved in the application of the AI Regulation to respect the confidentiality of 
information and data obtained in carrying out their tasks and activities. This is also extended to 
other national public authorities or bodies w hich supervise or enforce the respect of obligations under 
Union law protecting fundamental rights who may gain access to the technical documentation (Article 
64(6)). The penalty system in the proposed AI Regulation builds on the EU's new legislative 
frame work system but also on other existing legislation, such as General Data Protection Regulation. 
This implies that EU member States remain responsible for laying down the rules on penalties, 
including administrative fines, applicable to infringements of the  AI Regulation. However, some 
harmonization elements are provided, e.g. on the capping and types of infringements associated. 
Finally, the rationale for the shorter transitional period is to empower EU member States to lay down 
and adopt the relevant rules  on penalties ahead of the general application date of the AI Regulation.  
2.1.2.9   United States - Secure equipment act of 2021 (ID 73721) 
2.46.  The representative of China  provided the following statement. The Secure Devices Act of 
2021, requires the Federal Communications Commission (FCC) to revise the device authorization 
rules and to refuse to authorize information and communication devices that "pose a threat to US 
national security", including mobile phones, tablets, base stations, wireless routers, surveillance 
cameras and so on. Therefore a number of Chinese information and communication equipment 
enterprises, are involved. FCC authorization is a mandatory equipment a ccess requirement for 
information and communication products to enter the US market. Once the authorization is stopped, 
it causes great trade barriers. China hopes the US to stop implementing the act, treat information 
and communication equipment of all Me mbers equally, and follow the principle of national treatment 
and MFN and grant fair market access opportunities.  
 
21 For previous statements follow the thread under ID 737 . G/TBT/M/86  
 
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  2.47.  In response, the representative of the United States  provided the following statement. The 
Federal Communications Commission is charged with i ssuing implementing regulations, and those 
proposed regulations are scheduled to be developed and published by 22 November 2022 and will 
be notified to the WTO TBT Committee accordingly so we will let China know when that has been 
notified and would encour age you to provide comments.  
2.1.2.10   European Union - Regulations affecting spices (Regulation number EU 
2021/2246, dated 15 December 2021) (ID 73822) 
2.48.  The representative of India provided the following statement. The Republic of India is deeply 
concerned with the abrupt changes in the EU regulations and bringing them into effect without giving 
time to exporters to implement changes. This has impacted the Indian spice exporters adversely. 
The said Regulation is a concern under both TBT and SPS Agreements; hence it i s being raised in 
both the Committees. As per the Regulation (Regulation no. EU 2021/2246 dated 15 December 
2021), consignments of spices from India should be accompanied by an Official Certificate (Health 
Certificate), stating compliance with maximum resi due levels of ETO (Ethylene oxide expressed as 
the sum of ethylene oxide and 2 -chloro -ethanol). The Regulation applies to all products which fall 
under the CN Codes from 0904 to 0910 and 2103, thereby covering all spices and most of the spice 
products. Reg ulation 2021/2246, which was adopted by EU on 15 December 2021 with the date of 
taking effect as 6 January 2022, was notified on the WTO SPS website only on 14 January 2022, as 
a regular notification, after eight days from the date of taking effect. The st andard 60 days for 
consultation with the membership was not provided. Further, it had no provision for the comments.  
2.49.  The result of these abrupt changes in the regulations stranded many Indian spice 
consignments at several EU ports since December 2021 as th e Port Health authorities are demanding 
100% testing of ETO (in the case of consignments shipped before 6 January 2022) and an official 
certificate issued by India (in the case of consignments shipped on or after 6 January 2022). 
Cultivating and harvesting  spice crops take up to six months. The cumin seed, for example, is sown 
at the end of October/November 2021 and harvested in February/March 2022, i.e., 90 days crop. 
Hence the EU's MRL notification of 15 December will not be compliant with the current har vest cycle. 
The regulations and special conditions prescribed by the EU are trade -restrictive and render high 
costs and difficulties to the exporters, thereby posing a trade barrier to export spices from India. 
The trade barriers imposed by the EU pose the  risk of disruption of India's export of spices and other 
food products to the European Union. India, therefore, requests the EU to provide sufficient transition 
time and the implementation of the said Regulation may be put on hold and consider implementin g 
Regulation no. EU 2021/2246 to India spices from the next harvest cycle onwards.  
2.50.  In response, the representative of the European Union  provided the following statement. 
During 2021, several incidents of foodstuffs contaminated with ethylene oxide led to measures taken 
by the competent authorities of member States of the European Union, in order to ensure that only 
safe products remain in the market. Ethylene oxide (EtO) is classified in the EU as carcinogen and 
mutagen and reprotoxic disinfectant, and thu s it is not allowed for food and feed in the Union. In 
accordance with legal provisions for the products contaminated with ethylene oxide, no safe level of 
exposure for consumers can be defined and hence any level consumers may be exposed to, presents 
a potential risk to their health. The EU is aware that ethylene oxide is largely used in third countries 
to treat certain foodstuffs before export, as indicated in the high number of Rapid Alert System for 
Food and Feed (RASFF) notifications. Indeed more than 50 notifications have been submitted in 
2021 through the RASFF, which showed contamination with ethylene oxide of a broad range of 
commodities like several spices, guar gum, locust beans (including mucilages and thickeners derived 
from locust beans), calci um carbonate and food supplements containing botanicals originating in 
India. The Indian authorities were asked to take follow -up actions; nevertheless, non -compliant 
consignments of a wide range of commodities continued to arrive to the Union. As a conseq uence, 
the European Union has decided to take measures in order to mitigate the possible risk for the health 
of European consumers, since the problem appeared to go beyond findings relating to the 
responsibility of individual stakeholders for the complianc e of their exports with EU rules.  
2.51.  Commission Implementing Regulation (EU) 2019/179323 lays down the list of food and feed 
of non -animal origin and compound food subject to special conditions governing their entry into the 
 
22 For previous statements follow the thread under ID 738 . 
23 Commission Implementing Regulation (EU) 2019/1793 of 22 October 2019 on the temporary increase 
of offic ial controls and emergency measures governing the entry into the Union of certain goods from certain G/TBT/M/86  
 
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  Union, as well as to a temporary increase of official controls in its Annex II. Several commodities 
from certain third countries, including India, were added to Annex II to that Regulation, amended 
by Regulation (EU) 2021/224624, in order to strengthen the protection of public health in the EU, 
with respect to serious and high risk of contamination by ethylene oxide of man y commodities 
exported to the EU. Thus, each consignment of those commodities listed in Annex II shall be 
accompanied by an official certificate stating that the products have been sampled and analysed for 
ethylene oxide and by the results of sampling and analyses showing compliance with Regulation 
(EC) No 396/200525 on maximum residue levels of ethylene oxide. In addition, the consignments 
are subject to a harmonized level of official controls upon their arrival to the EU border. In addition 
to spices, oth er products originating in India were listed in Annex II to Regulation (EU) 2019/1793 
and are therefore subject to official controls and emergency measures governing their entry into the 
Union. Those products are sesamum seeds, due to the risk of contamina tion by ethylene oxide (and 
salmonella) and locust beans, locust beans seeds, mucilages and thickeners, whether or not 
modified, derived from locust beans or locust bean seeds, guar gum, sauces and preparations 
thereof, mixed condiments and mixed seasoning s, mustard flour and meal and prepared mustard, 
calcium carbonate and food supplements containing botanicals, due to the risk of contamination by 
ethylene oxide.  
2.52.  The Indian authorities were informed about the latest changes and amendments to Regulation 
(EU) 2019/1793 in December 2021. The Indian authorities are aware of the certification 
requirements for the products concerned. The EU would like to clarify that the measures under 
discussion are not TBT measures, but SPS measures and that they were notified under the SPS 
Agreement ( G/SPS/N/EU/538 ). Therefore, any further discussion on these measures, if considered 
necessary, should take place at the SPS Committee. In response to several requests for a smooth 
transition and, in order to allow for the continuation of safe trade for the co mmodities concerned in 
view of the serious risk of contamination by ethylene oxide, a consensus on transitional 
arrangements was found with member States. In this context, member States agreed to allow the 
entry into the Union, until 17 February 2022, of c onsignments of the commodities added to Annex 
II to Regulation (EU) 2019/1793 due to the risk of contamination by ethylene oxide which were not 
accompanied by a health certificate, provided that such consignments were shipped to the Union 
before 6 January 2022 and are subject to 100% of official controls, including sampling and laboratory 
analysis at border control posts. The European Union would like to stress that measures were taken 
since findings suggested that importers had not met their primary respon sibility to ensure that 
products exported to the European Union complied with EU requirements for the safety of products.  
2.1.2.11   European Union - Implementation of access regulation regarding collagen for 
human consumption (ID 73926) 
2.53.  The representative of China  provided the following statement. According to Commission 
Implementing Regulation (EU) 2021/405, China is included in the list of third countries authorized 
for the entry of collagen into EU in ANNEX IX, ANNEX XII and ANNEX XIII. EU should implement the 
above regulation and remove the warning on the registration page : " Collagen is not listed in the 
Annex to Commission Decision 2002/994/EC. According to Article 2 of the same Decision, collagen 
originating from China is not authorized to be imported into EU ", otherwise, it will cause great trade 
barriers for China's products.  
2.54.  In response, the representative of the European Union  provided the following statement. 
Commission Decision 2002/994/EC27 as last amended by Commission Implementing Decision (EU) 
 
third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament 
and of the Council and repealing Commission Regulati ons (EC) No 669/2009, (EU) No 884/2014, (EU) 
2015/175, (EU) 2017/186 and (EU) 2018/1660. (OJ L 277, 29.10. 2019, p. 89).  
24 Commission Implementing Regulation (EU) 2021/2246 of 15 December 2021 amending Implementing 
Regulation (EU) 2019/1793 on the temporar y increase of official controls and emergency measures governing 
the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 
and (EC) No 178/2002 of the European Parliament and of the Council. (OJ L 453, 17 .12.2021, p. 5).  
25 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 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, 1 6.3.2005, p. 1).  
26 For previous statements follow the thread under ID 739 . 
27 Commission Decision 2002/994/EC of 20 December 2002 concerning certain protective measures wit h 
regard to the products of animal origin imported from China (OJ L 348, 21.12.2002, p. 154).  G/TBT/M/86  
 
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  2015/106 828, applies to all products of animal origin imported from China and intended for human 
consumption or animal feed use. The Decision lists food and feed products authorized to be imported 
from China into the EU. Article 1 of this Decision applies to all p roducts of animal origin imported 
from China and intended for human consumption or animal feed use. Articles 2 and 3 of this Decision 
indicate possible derogations to the provisions in Article 1, which are included in parts I and II of the 
Annex to this De cision. Since collagen is not included amongst the possible exceptions (parts I and 
II of the Annex), it is actually not authorized to import collagen from China into the EU.  
2.1.2.12   United Kingdom - EC marking certificate for export of home textile items (ID 
74029) 
2.55.  The representative of India provided the following statement. The Republic of India is 
concerned about the Non -Tariff Barrier of CE Marking for Personal Protective Equipment imposed by 
the United Kingdom, specifically, about the markings affixed on two textile items i.e. Oven Gloves 
and Pot Holders. Post -Brexit, the United Kingdom has adopted EC Regulation (EC) No. 765/2008 
and Decision No.768/2008/EC for the CE Marking. The CE Marking indicates the conformity of the 
product with the Union Legislation ap plying to the product. The scope of the current certification 
requirement includes specific information like size, colour, filling, fabric material etc. Some of the 
challenges faced by the Indian manufacturers and exporters are: a. The  fabric design and co lour 
between the importers vary, but the EC certificate remains valid for a particular design alone, forcing 
manufacturers and exporters to seek a new certification for every design and colour. b. Obtaining 
an EC certificate is time -consuming. It takes bet ween 12 to 16 weeks to complete the entire 
certification process. c. The certification costs are very high, ranging between INR 150,000 and 
200,000. d. The impact of high CE certification cost is adverse on smaller consignments. e. Different 
buyers in the United Kingdom place orders with different designs and colours. These designs vary 
within a season and between the seasons. But each of these orders needs a separate certificate. 
f. Besides, MSMEs primarily employ women to produce these products. The barri ers imposed by 
these regulations negatively affect MSMEs, gender, and e -commerce. In a nutshell, instead of 
facilitating trade, this regulation is erecting artificial barriers. Hence, to remove this technical barrier 
and align with Article 2.2 of the TBT A greement, the United Kingdom is requested to authorize 
certification bodies to issue generalised certificates and or allow a change in the shell fabric design, 
colour length and width of the product. This, besides trade facilitation, will be beneficial to the 
exporters, MSMEs, e -commerce and the customers alike.  
2.56.  In response, the representative of the United Kingdom  provided the following statement. As 
we have not received any information from you on this issue in advance, we are sorry that we cannot 
comment  on the specifics of your statement, but we will refer your concerns to capital and respond 
in due course via your Enquiry Point.  
2.1.2.13   European Union - Commission implementing decision (EU) 2017/1357 on a 
restriction of Standard EN 60335 -2-9-2003+A 13 -2010 (ID 74130) 
2.57.  The representative of China  provided the following statement. China would like to suggest the 
following. 1. Standard EN 60335 -2-9-2003+A13 -2010 is applicable to the safety of domestic 
portable electric appliances with cooking functions such as bakin g, roasting and grilling with a rated 
voltage not exceeding 250 V. The air fryer is a class 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 fund amentally different from that of a conventional oven. If the EU fully adopts the 
standard EN 60335 -2-9-2003+A13 -2010 for testing the safety requirements of air fryers, this would 
lead to a mismatch between the testing provisions and the product, which woul d create unnecessary 
international trade barriers. EU should reconsider the classification of products based on the 
principles of operation of air fryers and set out the safety requirements and performance test 
methods that are compatible with the products . 2. The European Commission has restricted the 
"temperature rises are not measured on surfaces within 25 mm from the ventilation openings " in its 
Implementing Decision (EU) 2017/1357. As the air fryer is a product with internal and external 
circulation of  hot air, the temperature rises on the surfaces within 25 mm of the ventilation openings 
 
28 Commission Implementing Decision (EU) 2015/1068 of 1 July 2015 amending Decision 2002/994/EC 
concerning certain protective measures with regard to the products of animal origin imported from China (OJ L 
174, 3.7.2015, p. 30).  
29 For previous statements follow the thread under ID 740 . 
30 For previous statements follow the thread und er ID 741 . G/TBT/M/86  
 
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  are high. The implementation of the temperature rise requirements specified in Table Z101 of EN 
60335 -2-9:2003+A13:2010 would result in the  inconformity of air fryers with the EU market access 
requirements. It is recommended that the EU reassess the scientific basis of this restriction and 
exempt air fryers from the temperature rise measurement.  
2.58.  In response, the representative of the European Union  provided the followin g statement. 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 p rovisions regarding temperature limits of accessible 
non-functional surfaces. In particular, the standard allows several exclusions to the temperature 
limits, authorizing 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, Section 7.1 of the standard only requires a warning to be put on the surface 
with the highest temperature within the parts exceeding th e limit values. The colours of the warning 
label may differ from international warning colours which may confuse the users. Additionally, as a 
result of the ambiguity of the requirements under the standard, the standard can be interpreted as 
making it poss ible 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.  
2.59.  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 conformity with Directive 2014/35/EU. Having 
examined standard EN 60335 -2-9:2003, as last amended by A13:2010, in the Low Voltage Dire ctive 
Working Party, which is a group of sectoral experts, together with EU member States and 
stakeholders, the European Commission together with the majority of experts from member States 
agreed with the arguments presented by Germany and Norway. Conseque ntly, 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 stakeholders 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 standard as 
contained in Annex 1 point 2 of the TBT Agreement, namely that it is a "Document approved by a 
recognized body, that provi des, for common and repeated use, rules, guidelines or characteristics 
for products or related processes and production methods, with which compliance is not mandatory. " 
2.1.2.14   India - Approved models and manufacturers of solar photovoltaic modules order, 
2019 (I D 74231) 
2.60.  The representative 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 manufacturer s, and imported 
products and manufactures are treated unfavourably. In terms of review and feedback time, 
overseas enterprises are discriminated. The overseas enterprises are in less favourable competition 
condition, while Indian domestic manufacturers hav e advantages and are protected. It is not 
consistent with National Treatment of GATT and Articles 2.1, 5.1 and 5.2 of TBT. China suggests 
that the Ministry of New and Renewable Energy (MNRE) of India and the National Institute of Solar 
Energy (NISE) to adj ust the measures, treat domestic and foreign companies equally, besides, audit 
process and time schedule should be publicized, so as to improve the certification efficiency. 2. In 
NISE's Documentation and On -Site verification process, the certification sta ndards and process rules 
are not clear, lack of guidance for the manufacturers, no effective feedback and communication in 
ALMM  audit application process. It is against transparency principle in GATT and TBT Articles 5.1, 
5.2 and 5.6. A clear certification standards and auditing process should be publicized.  
2.61.  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 epidemic. Considering the persistence 
of the global epidemic and foreseeable travel restriction policies, it is obviously not possible for on -
 
31 For previous statements follow the thread under ID 742 . G/TBT/M/86  
 
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  site inspection of overseas manufacturer s. 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. 4. The fees charged for ALMM 
certification were unreasonable. Currently, this certification fee is evaluated and charged according 
to the total production capacity of the manufacturer, wh ich is much higher than the actual production 
capacity quota allocated for export to India market. Therefore, this measure is against the obligation 
to control the fee in Article 8.1(a) of GATT, not to create unnecessary obstacles to trade in 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 fulfil the purpose 
of ensuring the quality of photovoltaic modules, and the additional ALMM certification list is 
unnecessary, burdensome and can become an  obstacle to trade. 2019 ALMM Decree restricts trade 
while no further contribution in achieving legitimate objectives, it is against Article 2.2 of TBT 
Agreement. China suggests that Indian withdraws the ALMM decree.  
2.62.  In response, the representative of India provided the following statement. India has not 
received any information on this issue in advance; we cannot comment on any statement uploaded 
today or tomorrow. We will, however, refer such a statement to the capital for a response later.  
2.1.2.15   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 74332) 
2.63.  The representative of China  provided the following statement. 1. EU clarifies the regulatory 
timeline for the new regulation, and whether it is valid for newly launched products or all products 
on sale; 2. EU publishes relevant test standards and conformity assessment guiding docume nts as 
soon as possible, allowing manufacturers to conduct product regulatory compliance analysis in 
advance and to modify product design in time to meet regulatory requirements; 3. EU takes 
reference on the current status of the related enterprises' readi ness during the development of this 
standard. It is to ensure that before the implementation of the regulation, there are enough test 
laboratories and certification bodies which have the test environment and test resources needed, 
and can accurately assess  the product compliance. All these can ensure the effective implementation 
of the regulation.  
2.64.  In response, the representative of the European Union  provided the following statement. 
Commission Delegated Regulation 2022/30 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 the 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 requires 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 ren ders 
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 of elaborating the relevant standards. The Commission 
Delegated Regulation 2022/30 was adopted on 29 October 2021.  
2.1.2.16   Republic of Korea - Regulation for supporting low carbon solar module product 
(ID 74433) 
2.65.  The representative of China  provided the following statement. 1. The life cycle assessment 
(LCA) report submitted by  Chinese 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 
 
32 For previous statements follow the thread under ID 743 . 
33 For previous stateme nts follow the thread under ID 744 . G/TBT/M/86  
 
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  member States. China hopes that Korea side could clearly explain its implementation criteria fo r the 
review of the LCA report. Before formulating/issuing the implementation criteria for 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 Korea 
side should publish the list of qualified third -party certification institutions for companies' choices. 
3. The reviewing time of the report should consider other Members ' practices , that is, approval shall 
be completed within 30 days after acceptance, so as to improve the efficiency. 4. As too much trade 
secret data and industry sensitive information are submitted which is unnecessary and unreasonable, 
the Korean side should reasonably set the scope of data submission in  accordance with international 
practice.  
2.66.  In response, the representative of the Republic of Korea  provided the following statement. 
We have not received any information regarding your Specific Concerns prior to your comments. So 
we are not prepared with re plies specifically today. Nevertheless, we will convey your comments 
faithfully to our competent regulatory authority for internal discussion and provision of an 
appropriate response. And in this regard, if China submit us your comments in writing, the 
responsible authority could reply in writing also.  
2.1.2.17   European Union - Regulation (EU) 2019/320 on caller location in emergency 
communications from mobile devices , G/TBT/N/EU/589  (ID 74534) 
2.67.  The representative of China  provided the following statement. 1. China recommends that the 
EU fully considers whether the industry has prepared or not when formulating regulations and 
conformity assessment procedures in the future and before the regulations are implemented, to 
conduct research on the readiness of test environment and testing resources me eting the 
requirements of the regulations in the industry, and the products can be fully evaluated to ensure 
that the regulations can be implemented more effectively; 2. China recommends that the EU should 
consider the enforceability of the regulation and postpone the mandatory implementation date by 
more than six months (i.e. after 17 September 2022); or introduce a relevant exemption clause, 
that manufacturers are allowed to prove their product meeting the requirements by self -declaration 
before 17 Septem ber 2022.  
2.68.  In response, the representative of the European Union  provided the following statement. 
Commission Delegated Regulation 2019/320 was notified on 24 July 2018 with a 60 -day commenting 
period under reference number G/TBT/N/EU/589 . No comments were received during the 
commenti ng period. The Delegated Regulation aims to ensure that hand -held mobile telephones with 
advanced computing capabilities (commonly known as "smartphones") ensure access to emergency 
services. This will be done by requiring mobile device producers to suppor t technical solutions for 
the reception and processing of location data derived from Wi -Fi signals, and data from Global 
Navigation Satellite Systems (GNSS) compatible and interoperable with at least the Galileo system 
(Galileo is the European global navig ation satellite system established under Regulation (EU) No 
1285/2013) for the purpose of making emergency communications more effective. In the description 
of the objective, the EU has previously provided that the impact on mobile device manufacturers 
were expected to be minimal as they are targeted towards those mobile phones that are already 
GNSS -enabled. Nearly all new smartphones currently on the market have GNSS capability. The 
Delegated Regulation would simply reinforce current market trends by addin g legal certainty. The 
Commission Delegated Regulation 2019/320 was adopted on 12 December 2018.  
2.1.2.18   Indonesia - Remote factory audit for air conditioners (ID 74635) 
2.69.  The representative of Thailand  provided the following statement. Thailand appreciates 
Indonesi a's clarifications on factory audits for issuing or renewing SNI certificate for air conditioners 
through our TBT enquiry points and bilateral meeting in November 2021. However, we still have 
concerns regarding the onsite factory audits. Due to COVID -19 in ternational travel restrictions, 
companies have difficulties to obtain or renew SNI certification since Indonesia does not allow remote 
factory audits. Therefore, Thailand encourages Indonesia to consider allowing remote factory audits 
for air conditioners  to facilitate trade and minimize technical barrier to trade in the future. As 
Thailand and Indonesia are members of the Association of Southeast Asian Nations (ASEAN), we 
would like Indonesia to consider the possibilities of utilizing ASEAN Harmonised Reg ulatory Regime 
 
34 For previous statements follow the thread under ID 745 . 
35 For previous statements follow the thread under ID 746 . G/TBT/M/86  
 
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  for Electrical and Electronic Equipment (AHEEER) to improve the trade flows between Thailand and 
Indonesia. Thailand would appreciate Indonesia's consideration of our concerns and look forward to 
the successful collaboration with Indonesia.  
2.70.  In response, the representative of Indonesia  provided the following statement. Indonesia 
would like to reiterate its response through the enquiry point that based on the Circular Letter of the 
Head of BPPI No 202/BPPI/IND/VIII/2020 dated 10 August 2020, ce rtification process for mandatory 
SNI in the industrial sector is carried out in accordance with the provisions stated on the Minister 
Regulation. It includes requirement for on -site factory visit both for domestic and foreign 
manufactures. As such, all do mestic and foreign manufacturers are also required to undergo onsite 
factory visits/ inspection as part of the conformity assessment procedures. Conformity assessment 
procedure is conducted based on conformity assessment scheme stated in the related regula tion. 
For foreign manufactures, onsite inspection and/or factory visits can still be conducted as long as 
the destination countries open their border for representative from Indonesia conformity assessment 
body to perform the onsite inspection. Ministry of  Industry has no authority to prevent conformity 
assessment body to perform onsite inspection to a particular country due to COVID -19 
circumstances. Indonesia would also like to inform Thailand that according to the report of SNI 
Certification, several pro ducts in Thailand have been successfully inspected on -site by Indonesian 
certification body. Related to the acceptance of conformity assessment through AHEEERR 
mechanisms, will be discussed in ASEAN fora.  
2.1.2.19   Japan - Inspection system for sports goods and toys  and non -acceptance of test 
reports from Indian test houses (ID 74736) 
2.71.  The representative of India provided the following statement. The Republic of India is 
concerned about the trade barriers faced by the Indian sports goods and toys exporters to Japan. 
There are two issues: the lab testing and certification of toys exported from India to Japan and the 
100% inspection of consignments that arrive in Japan instead of a test check of samples. Under 
Japan Food Sanitation Law (JFSL) (Act Number 233, 1947), Lab -verified compliance with Sections 
IV and V of the JFSL is mandatory for applicable children's products before they can enter the 
Japanese market. Further, ST Standards and ST Mark programmes are established by the JTA (Japan 
Toy Association) to cover the l egal aspect of the JFSL. To distribute and sell toys in Japan, 
manufacturers must demonstrate that they are compliant with the Japan Food Sanitation Act (JFSL) 
and/or with the Japan Toy Safety Standard (ST Standard). In addition, all toys compliant with th e 
ST standard must display the Safety Toy Mark (ST Mark). Japan Toys Association, a government 
recognized organisation, has nominated agencies to test and certify toys meant for the Japanese 
market. Unfortunately, no agencies/ labs in India are assigned or  accredited to carry out such tests. 
In previous interactions between the agencies of both countries, Japan has promised to share a list 
of such agencies outside Japan, including those labs in India, that are nominated by JTA to carry out 
tests and certify  the toys. But so far, this information is not available.  
2.72.  Further, despite India's testing labs being ILAC accredited, their certificates are not accepted 
by the Japanese authorities. Presently the toys manufacturers are sending samples to Japan for 
certification. These barriers imposed compel Indian manufacturers to send the products to testing 
labs in Japan, resulting in avoidable high costs. However, we understand that Japan accepts the 
certification provided by several other countries but not India. Fin ally, no sample inspections of 
consignments are done for the consignments that arrive in Japan. Instead, the entire consignment 
of sports goods and toys is inspected, which causes delays and additional costs to exporters. The 
insistence of certificates fro m Japanese labs and the insistence of 100% inspection of sports goods 
and toys imports from India are inconsistent with Article 5.1.2 of the TBT Agreement. Hence India 
requests Japan to: a. Share the list of labs outside Japan accredited by ILAC to test an d certify sports 
goods and toys. b. Expand the coverage of accredited labs in India. c. Accept the certificates issued 
by the Indian Test houses accredited by ILAC and expand the coverage of labs in India for 
accreditation. d. India also requests Japan to stop 100% testing of sporting goods and toys imported 
into Japan from India.  
2.73.  In response, the representative of Japan  provided the following statement. I would like to 
express my appreciation for India's continuous bilateral trade interest with Japan. Howe ver, it is 
regretful that India had no communication with us as we have contacted with your side through 
Enquiry Point and Permanent Mission in Geneva last month in order to understand India's concern. 
 
36 For previous statements follow the thread under ID 747 . G/TBT/M/86  
 
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  In fact, Japan even requested information on this matt er in June of last year but India had no 
response and withdrew the issue at that time of the TBT meeting. However just today India provided 
relevant information in the form of the STC statement here that Japanese government will of course 
consider and get back to you accordingly.  
2.1.2.20   India - Import Policy of Air Conditioners with Refrigerants (ID 74837) 
2.74.  The representative of Thailand  provided the following statement. Thailand would like to thank 
India for providing an opportunity to Thailand to express our conc erns on the import policy of air 
conditioners with refrigerants through a bilateral meeting in November 2021. However, Thai 
companies still meet difficulties in exporting air conditioners with refrigerants to India and we would 
like to raise our concerns a s follows: Thailand notes that the Notification No. 41/2015 dated 15 
October 2020 issued by the Ministry of Commerce and Industry of India, prohibiting the import of 
air conditioners with refrigerants to India has not been notified to WTO. This measure lac ks scientific 
evidence to identify whether there is any advantage, disadvantage, or difference in importing air 
conditioners with refrigerants or without refrigerants. Thailand would like to point out that, compared 
to domestic companies, Thai companies ha ve to undergo more processes which affect opportunities 
for placing air conditioners in the markets. Thus, this measure does not provide the same treatment 
for domestic and imported air conditioners but creates unnecessary obstacles to international trade.  
Moreover, filling in refrigerants after importing could affect the quality of the products. Thailand 
would like to reiterate that this measure is against non -discriminatory principles in the TBT 
Agreement. According to Article 2.1 of the Agreement, "produ cts 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 ". Hence, Thailand strongly 
requests India to review th is measure by taking into account the non -discriminatory principles, and 
consider allowing the import of air conditioners with refrigerants in order to avoid creating 
unnecessary obstacles to international trade.  
2.75.  In response, the representative 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 pl ant 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 (HC FCs) has been prohibited since 1 
July 2015.  
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 encryptio n products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29438) 
2.76.  The representative 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 nature of the expert review that are 
prescribed by t he "Guidelines for grading of classified cybersecurity protection ", (ii) the lack of clarity 
in certain definitions, and (iii) the subsequent unwarranted and significant market entry restrictions. 
The EU calls for enhanced proportionality and transparency in the implementation of the Cyber -
MLPS.  
2.77.  The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's "Regulation on the Administration of Commercial Cipher Codes " and 
"Cyber Security Multi -Level Protecti on Scheme. " Japan would like to refer to the previous statement 
we made at the last TBT Committee in November 2021. Japan requests that China provide relevant 
information regarding the current revision process for the "Regulation on the Administration of 
Commercial Cipher Codes " for which the public consultation was scheduled to be finished by 
19 September 2020, and for the current drafting process of Cyber Security Multi -Level Protection 
 
37 For previous statements follow the thread under ID 748 . 
38 For previous statements follow the thread under ID 294 . G/TBT/M/86  
 
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  Scheme that China explained at the last TBT Committee, and that those  regulations be implemented 
in a transparent manner.  
2.78.  In response, the representative 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 varie ties 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 encryption products fully reflects the principles of non -discrim ination 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 p ublic interest, and implements voluntary testing and 
certification on other commercial encryption products. Regarding the MLPS concerned by the two 
Members, with technology development, in response to more complicated cyber security 
circumstances, the info rmation 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 securit y MLPS. To fulfill 
the requirements in Cyber -security Law, regulation on cyber -security MLPS is under drafting, which 
was published for comments and will replace the former administrative measures on information 
security MLPS.  
2.1.3.2   China - Cyberspace Administra tion of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53339) 
2.79.  The representative of the European Union  provided the following statement. The EU has raised 
the Security Review of Network Products and Se rvices, including the Cybersecurity Review Measures, 
in this Committee on several occasions, stressing our concerns related to these measures, which 
entered into force on 1 June 2020 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 charge of the security review, raising 
concerns for foreign ICT operators. The Amended Measures contain few explana tions 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 Amend ed Measures. The Amended Measures have significantly 
increased the scope of application and many processors need time to understand and cope with their 
compliance obligations and the related business impact.  
2.80.  The Measures expand the scope of the application  from Critical Information Infrastructure 
Operator's (CIIO) purchase of network products and services, to all data processors carrying out 
data processing activities. The expanded scope is very broad. For all the other data processors, 
which are not Critic al 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 necessary to the extent that it determines if and when an application would have 
to be filed. The EU urges China to c larify 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.  
2.81.  The EU seeks clarification on the following points. 1. The continued use of "listing in a foreign 
country ". Does this indicate the regulatory intention to exclude operators listed in Hong Kong from 
the obligation of applying for a mandatory Cybersecurity review? 2. Based on the previou s draft, 
entities subject to Cybersecurity reviews have changed from "data processors " to "online platform 
operators ". The final Measures do not define "online platform operators ", but the Draft Regulations 
define it as "data processors who provide Interne t platform services such as information publishing, 
social networking, transaction, payment or audio -visual services ". The EU urges China to clarify if 
the scope of "online platform operators " is narrower than "data processors ", which was used 
previously a nd excludes self -operated e -commerce services of fast -moving consumer goods 
companies that do not provide online platform services. The vagueness of "online platform 
operators " leaves room for interpretation by regulators. 3. Neither "core data " nor "impor tant data " 
are clearly defined. The Measures include important telecommunication products as one kind of 
 
39 For previous statements follow the thread under ID 533 . G/TBT/M/86  
 
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  "network products and services ". However, the Measures still do not provide a specific scope of 
"network products and services ". This leads to the defi nition of "important communication product " 
to be even more unclear. Therefore  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 Measure does not become a market access barrier.  
2.82.  The representative of Japan  provided th e following statement. Japan has its interest in and 
concerns with regard to the Cyber Security Review and would like to refer to the previous statement 
we made at the last TBT Committee in November 2021. The amendment of Cybersecurity Review 
Measures ente red into force in China 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 Pro tection 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 cybersecurity review under the Measures. 
Predictability is important for  conducting sound business and Japan requests that China operate the 
regulations in a transparent manner to ensure appropriate predictability so that the regulation does 
not become an impediment to business.  
2.83.  In response, the representative of China  provide d the following statement. In recent years, 
with the development of network information technology and further opening -up of cyberspace in 
China, more and more network products and services have entered into the key information 
infrastructure sectors. Whil e taking advantage of the convenient conditions for providing products 
and services, some network products and services providers illegally access users' important data, 
control and interfere with critical information infrastructure operation, stop the sup plies of its 
technologies, products, and services for non -technical or commercial reasons, which poses serious 
risks and challenges to the national cyber security of China, especially the supply chain security of 
critical information infrastructure. Drawin g on common international practices, China formulated the 
Draft implementing measures for Cybersecurity Review of Network Products and Services in 2017. 
In June 2020, the Measures for Cybersecurity Review came into effect, while the Draft implementing 
meas ures for Cybersecurity Review of Network Products and Services (Trial) was abolished at the 
same time. From 15 February 2022, the revised Cyber Security Review Measures came into force.  
2.84.  The establishment of a cyber security review system aims to detect and  avoid risks and 
hazards brought to critical information infrastructure by purchasing products and services as early 
as possible, ensuring the supply chain security of critical information infrastructure, and safeguarding 
national security through cyber se curity review. In accordance with laws and regulations, t he 
Chinese authority administers the Internet and strengthens cybersecurity and data security 
management. This is not only necessary to safeguard personal information security and national 
security, but also the common practices of other Members. The security review does not discriminate 
against foreign technologies and products or restrict the entry of foreign products into the Chinese 
market. China will, as always, welcome foreign products and servi ces to enter the Chinese market 
as long as they comply with the laws and regulations.  
2.1.3.3   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 63040) 
2.85.  The representative of Thailand  provided the following statement. Thailand once aga in would 
like to thank India for the opportunity to discuss the impacts of the Quality Control Orders for 
Chemical and Petrochemical Substances to Thai exporters in the bilateral meeting in November last 
year, where India has clarified the licensing proces s for imported products, which usually takes 3 -5 
 
40 For previous statements follow the thread under ID 630 . G/TBT/M/86  
 
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  months with onsite factory audits. However, in the light of the COVID -19 pandemic and international 
travel restrictions, India suspends onsite factory audits and provides no alternatives for the factory 
audits to facilitate the licensing application. This situation delays the granting of the licence and 
directly affects foreign manufacturers who cannot export their products to India. To reduce the 
impacts of the measures while the pandemic is still ongoing, T hailand would like to reiterate our 
request for India to consider implementing alternative measures. Thailand understands the difficulty 
in conducting regular onsite factory audits during the pandemic, therefore, Thailand suggests that 
India implement remo te factory audits. In the case that remote factory audits cannot be conducted, 
Thailand requests India to extend the enforcement date of the measures for 360 days.  
2.86.  The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. The EU remains concerned over 
the visible trend towards mandatory domestic standards in India that deviate from international 
ones in a growing number of sectors. In this case, they pertain t o a whole range of chemicals and 
petrochemicals products under the HS chapters 28 and 29. The EU took note of all Indian TBT 
notifications pertaining to Quality Control Orders (QCOs) for chemical and petrochemical substances 
over the past two years. The EU  would like to recall that some QCO notifications do not have a 
determined date of entry into force. In fact, the entry into force is dependent on the adoption date, 
which is not indicated in the notification. Could India provide structured information reg arding the 
planned time for the adoption of these measures? 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 r epeated 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 imple mented and of those that are yet to be implemented, together with 
copies of relevant Quality Control Orders.  
2.87.  The European Union would like to recall its request for clarifications explaining the reasons 
for establishing India -specific Quality Control Order s when these chemical and petrochemical 
products already comply with internationally recognized standards. The EU would like to remind the 
authorities of India that in accordance with the TBT Agreement, standards are considered voluntary, 
whereas mandatory  standards are considered as technical regulations. The EU 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 c reating 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.  
2.88.  The representative of the United States  provided the following statemen t. As of March 2022, 
India's Ministry of Chemicals and Fertilizers (MoCF) notified 44 Quality Control Orders (QCO) to the 
WTO TBT Committee. Each QCO appears to identify substances that correspond to or fall under the 
72 identified chemicals and petrochemi cals for which India intends to mandate compliance to 
standards set by the Bureau of Indian Standards (BIS). We continue to highlight US industry's 
concerns regarding the Polyethylene Material for Moulding and Extrusion (Quality Control) Order, 
2020 (Polye thylene QCO), notified as G/TBT/N/IND/191 , which mandates the marking of the 
smallest unit -level package of polyethylene product delivered to the customer with "designation 
codes" identifying an array of technical information (e.g., a product's melting point, density, 
processing me thod, and application.) It would be helpful if India could explain the intended objective 
of the labelling and who the labelling is intended to inform. We reiterate US industry's comments 
that such requirements have not been applied to polyethylene product s in other markets and there 
has been no 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 taken 
stakeholder input into account as to how  industry can best comply with the new designation code 
measures.  
2.89.  We have reported US industry's concern that, as proposed, requiring the labelling 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, delays, and additional costs for exporters. We are 
concerned about possible confusion on the part of the Indian cust omer in deciphering the code as 
the product moves through the chain of custody, as well as confusion on the part of any third country 
customer 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 G/TBT/M/86  
 
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  imports of, and access to, essential materials used by Indian health care, pharmaceutical, and other 
high value Indian export -critical sectors. We recommend that India provide the web site links to 
and/or complete copies of the BIS proposed standards as well as any referenced standards in the 
notified QCOs and any future QCO notifications. With respect to the previously notified QCOs, we 
recommend that such website links and/or copies b e notified as addenda. Without access to the BIS 
standards, Members and industry may be unable to understand the QCOs or provide meaningful 
comments.  
2.90.  The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the foll owing 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, and terephthalic ac id, which were notified 
by G/TBT/N/IND/116 , G/TBT/N/ IND/123  and G/TBT/N/IND/12 4. Firstly, we would like to thank India 
for postponing the enforcement date on the products concerned until 22 June 2022. Secondly, given 
that the pandemic will not likely end in the short term and it is still difficult to conduct on -site 
inspections unde r the current situation, we would like to urge India to postpone the implementation 
of the above mentioned products once again. In addition, we still suggest that India implement 
alternative measures during the pandemic regarding all products concerned, su ch 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 inspection resulted fr om international travel restrictions.  
2.91.  The representative of Singapore  provided the following statement. Singapore echoes the 
concerns raised by other Members, and we would like to reiterate our concerns expressed at the 
previous meetings of this Committee.  We remain concerned about the operational challenges that 
we had outlined previously vis -à-vis the labelling requirements for polyethylene materials used for 
moulding and extrusion. We respectfully request for India to positively consider alternatives tha t 
have been proposed by the industry to meet the information requirements of the Quality Control 
Orders on polyethylene products, to ensure that the mandatory labelling requirements are not too 
onerous and challenging for the industry to comply with. We al so understand that India is looking 
to allow virtual inspections as part of the certification process. We remain interested in, and look 
forward to working with India to initiate these inspections, whether virtual or in -person, as soon as 
possible, to faci litate progress in the certification process for the industry. For any new additional 
Quality Control Orders, Singapore would like to reiterate our request for India to provide specific 
website links and/or copies of the proposed BIS standards together wit h the notification to the WTO 
in a timely manner, to enable interested parties to acquaint themselves with the new requirements, 
and provide meaningful comments to India. Finally, we respectfully urge India, as per its obligations 
under the TBT Agreement, to align the standards within the Quality Control Orders with international 
standards which already exist, to reduce industry's compliance costs, and to ensure that measures 
imposed are not more trade -restrictive than necessary.  
2.92.  In response, the representa tive of India provided the following statement. 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 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 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 BI S (Conformity Assessment) Regulations, 2018, to undertake virtual inspection for 
conformity assessment activities as an alternative. Factory inspections were on hold due to the 
restrictions on international travel because of the COVID -19 pandemic. However,  the nomination of 
BIS officers is being considered for carrying out the factory inspection for applications received from 
foreign manufacturers. Mainly, where the country to be visited facilitates the visit of fully vaccinated 
BIS officers who carry negat ive RT -PCR test reports, without any restrictions like quarantine and RT -
PCR test upon arrival.  
2.93.  In accordance with the Code of Good Practice of WTO -TBT Agreement and as a policy, BIS 
tries to align Indian Standards with International Standards of ISO and I EC, where available and to 
the extent possible, considering the specific climatic/environmental conditions and technological 
development in the country. Around 80% of Indian Standards, for which corresponding ISO & IEC 
standards are available, are harmoniz ed with their ISO/IEC counterparts. In response to the G/TBT/M/86  
 
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  statement of the US and Singapore, the details of QCOs and the relevant standards are available on 
the BIS website.41 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.  
2.1.3.4   Bangladesh - Hazardous Waste (E -waste ) Management Rules, 2019, 
G/TB T/N/BGD/3 , G/TBT/N /BGD/3/Add.1  (ID 62042) 
2.94.  The representative of the United States  provided the following statement. On 10 June 2021, 
Bangladesh published an updated draft of its Hazardous Waste (E -Waste) Management Regulation, 
2021 (E -waste Rules). US industry shared its co mments and concerns with the draft regulation with 
the Ministry of Environment, Forest and Climate Change in September 2021, and reiterated its 
remaining concerns in January 2022. Based on an unofficial translation of the regulation and industry 
reports , we understand that the updated draft E -waste Rules removed threshold limits for a number 
of substances, a request that both US industry and the US Government had made in response to 
the original notification, G/TBT/N/BGD/3 . While we appreciate these changes, the June 2021 draft 
of the E-waste Rules lacks certain exemptions commonly granted by regulators in other countries 
with respect to the remaining substances. For instance, although lead is commonly categorized as 
hazardous, exemptions are usually provided for certain uses of lead, e .g., use in the solder of certain 
electronics exposed to high and low temperatures, use in shielding of X -ray and MRI machines. The 
absence of such exemptions can potentially disrupt the supply of important electrical and electronic 
goods in Bangladesh. Th us, we encourage Bangladesh to grant exemptions commonly granted by 
regulators in other markets, as highlighted in stakeholder comments.  
2.95.  Furthermore, we continue to lack clarity regarding how Bangladesh plans to implement the 
E-waste Rules. Specifically, t he E-waste Rules appear to lack information on implementation 
timelines, product reporting (particularly if products fall under more than one category), registration 
deadlines, information that would inform the design of an effective e -waste management sys tem, 
and points of contact within the Bangladeshi government to whom industry can direct clarifying 
questions. We urge Bangladesh to make this information available to the public, so that industry can 
engage regulators and comply with the E -waste Rules. Th e United States also asks that Bangladesh 
confirm whether it will release a more detailed explanatory guide to the E -waste Rules for industry. 
Given the broad scope of the E -waste rules, we encourage Bangladesh to provide a reasonable 
transition period, of  at least one year, for industry to adapt its products or methods of production to 
the new requirements. Further, has Bangladesh considered how long it would take for the 
development, establishment, and certification of e -waste management systems, includin g 
benchmarks used by certified operators? Finally, we ask that Bangladesh notify the latest revised E -
waste Rules to the WTO TBT Committee, provide a public comment period of at least 60 days, and 
take comments received into account before finalizing the r egulation.  
2.96.  In response, the representative  of Bangladesh  provided the following statement. Bangladesh 
thanks the US for their continued interest and concern about the Bangladesh E -waste Management 
Rule, 2021 (initially it was 2019, it is revamped). In this regard Bangladesh likes to refer to its 
statement made in the last TBT Committee meeting a nd also the submission in G/TBT/W/ 759 dated 
22 June 2021. Bangladesh would also like to discuss bilaterally with the US regarding the concerns, 
and our submission and reply.  
2.1.3.5   India - Indian standards and import restrictions in the automotive sector (Quality 
Control Orders): wheel rims, saf ety glass, helmets, G/TBT/ N/IND/118 , 
G/TBT/N/IND/147 , G/TBT/N/IND/167  (ID 64943) 
2.97.  The representative of the European Union  provided the following statement. India has defined 
and introduced specific standards and certification requirements for a number of products across 
sectors that require on -site, in person audits - the so -called Quality Control Orders (QCOs) which 
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. However, for almo st two years Indian auditors are not in a position to conduct international 
 
41 https://standardsbis.bsbedge.com/  and https://www.bis.gov.in/index.php/product -
certification/products -under -compulsory -certification/scheme -i-mark-scheme/ . 
42 For previous statements follow the thread under ID 620 . 
43 For previous statements follow the thread under ID 649 . G/TBT/M/86  
 
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  audits due to the COVID -19 pandemic. Unfortunately, India has refused to consider meaningful 
alternative options, such as virtual audits or audits conducted by internationally reco gnised third 
agencies/entities. Consequently, European Union companies, despite doing all that is necessary to 
meet the Indian requirements, are not able to obtain the required Indian certification or marking. 
Thus, while EU and other foreign companies are  not able to access the Indian market due to the lack 
of alternatives to physical audits on India's side, Indian auditors are conducting domestic audits that 
allow domestic companies to receive certification/marking and place their products on the market.  
2.98.  This is a clear case of discrimination against EU and other foreign manufacturers. In this 
context, the EU welcomes the steps taken by the BIS to allow its auditors to audit foreign 
manufacturing plants. However, according to EU industry such audits have n ot yet been possible, 
despite the confirmation by a number of EU embassies that fully vaccinated BIS officials do not have 
to be quarantined at EU entry. In fact, some of the foreign manufacturers had even deposited licence 
fees. This delay of physical aud its perpetuates the current difficult situation of EU importers, 
prolonging the discrimination between local and foreign companies. The EU would welcome any 
update by India on when foreign audits would resume. The EU would like to recall that the QCOs in 
question have a protectionist orientation and the ever -increasing number of QCOs is sending 
worrying signals to EU industry, EU investors, and EU member States. Once these measures come 
into force, they will cause extra burden and economic cost to the EU in dustry that will have to 
undergo cumbersome procedures to obtain necessary permissions and/or licences for products 
already certified under established international standards. In this context, the QCOs would add little 
value for Indian consumers, making t he reason of their introduction not evident.  
2.99.  Furthermore, the implementation of the QCOs for foreign companies with production facilities 
outside India is likely to continue to prove difficult due to the existing restrictions on international 
travel in vie w of the ongoing COVID -19 pandemic. In addition, when international travel 
recommences, the BIS will be faced with a large backlog of applications that the EU hopes would be 
cleared in a transparent and non -discriminatory manner. Furthermore, we would like  to receive some 
clarity from India on the validity of these physical audits. We understand that they have limited 
validity of two years only, after which the procedure for renewal of authorization is not clear. The 
current procedure is already unduly cumb ersome and costly requiring a renewal every two years will 
add the difficulty of doing business and ensure that the supply chain continues to operate in 
uncertainty. At a time when businesses across the world have been heavily impacted by the COVID -
19 pand emic, it would be important to facilitate trade. That is why the EU would like to voice once 
again its concerns regarding the QCOs on automotive safety glass and wheel rims.  
2.100.   The EU appreciates further postponement of the QCO on safety glass until 1 April 2 023. The 
planned entry into force of the QCO on wheel rims, set for 21 September 2022, is of concern, given 
that continued COVID -19 pandemic and restrictions on international travel may not allow for its 
actual implementation. It is worth noting that the s upply chain cycle from physical audit to import 
of wheel rims in India is between four to six months long, taking into account the production, and 
travel time. An implementation date of 21 September 2022 implies that audits have to be conducted 
immediately , without any further delay, otherwise, the risk is that on 21 September 2022, when the 
QCO for wheel rims is due to enter into force, production lines may come to a standstill due to the 
lack of supply of BIS -compliant wheel rims. Such a situation would n egatively affect car -
manufacturing operations of EU companies in India, which would undoubtedly have a negative 
impact on the Indian economy and Indian consumers. Therefore, the EU would like to suggest that 
India considers further postponement, of at leas t six months, of the entry into force of the QCO for 
wheel rims, with a view to ensuring the continuity of imports of this product into India.  
2.101.   The EU would also like to urge India to consider virtual audits or audits performed by BIS 
recognized third -party certification experts in the location of the manufacturing plants. Without such 
flexible options, and taking into account the persisting COVID -19 restrictions, India should consider 
longer lead -times for the implementation of BIS requirements (e.g. 12 mon ths). The EU would also 
like to reiterate that safety glass and wheel rims manufactured in the EU are subject to a rigorous 
certification process, in line with established international standards, which are not much different 
from the Indian ones, introduc ed by the QCOs in question. The EU would therefore like to repeat its 
suggestion to keep the BIS marking as optional for components, which are already in compliance 
with the UN marking requirements. The EU would like to ask India if it would be ready to ac cept 
provisionally UN certificates and markings. The EU, therefore, requests India to reconsider the 
introduction of the QCOs on automotive safety glass and wheel rims. Furthermore, the EU would like G/TBT/M/86  
 
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  to recall its suggestion to keep the BIS marking as opti onal for components, which are already in 
compliance with the current marking requirements.  
2.102.   In response, the representative of India provided the following statement. As acknowledged 
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 requirement for the grant of licence. Licence to use the Standard Mark on 
a produ ct 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 audits for conformity 
assessment activities as an alt ernative. Factory inspections were on hold due to the restrictions on 
international travel because of the COVID -19 pandemic, this is no discrimination against the EU or 
any other country. However, the nomination of BIS officers is being considered for carr ying out the 
factory inspection for applications received from foreign manufacturers. Mainly, where the country 
to be visited facilitates the visit of fully vaccinated BIS officers who carry negative RT -PCR test 
reports, without any restrictions like quara ntine and RT -PCR test upon arrival.  
2.1.3.6   China - Commercial Cryptography Administrative Regulations (ID 64444) 
2.103.   The representative of the European Union  provided the following statement. The EU is 
concerned about this implementation measure of the Cryptography L aw, and sent comments to the 
State Cryptography Administration of the People's Republic of China (SCA) in September 2020. 
Specifically, concerns relate to (i) the scope of the law; (ii) the lack of clarity of concepts & precision 
of procedures; (iii) the p rotection of intellectual property; (iv) the imposition of pre -market and 
export controls; (v) the requirements around testing & certification; (vi) the imposition of additional 
"national security reviews"; and (vii) the use of domestic standards, along wi th the lack of 
meaningful access to pertinent Chinese standards development organizations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in order to ensure that 
legal and regulatory requirements are appl ied on a non -discriminatory basis, do not favour specific 
technologies, do not limit market access and do not lead to forced transfer of intellectual property. 
Additionally, the EU encourages the SCA to open up, in practice, the "Cryptography Industry 
Standardisation Technical Committee" (CISTC) to foreign -invested industry based in China. The EU 
would appreciate its comments being taken into consideration and invites China to notify the draft 
regulations to the WTO.  
2.104.   In response, the representative of China  provided the following statement. The Revised 
Regulations on the Administration of Commercial Cryptography are listed in Legislation Plan. The 
revision of the Regulations will follow the law -based, democratic, and scientific principles. And it will 
be ope n, transparent, and on a scientific basis.  
2.1.3.7   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 67845) 
2.105.   The representative of the United States  provided the following statement. The United States 
would like to refer back to its statement from the November 2021 TBT Committee on this STC. Could 
Mexico please provide an update on the status of this measure no w that it has notified a revision to 
the TBT Committee? 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 the NOM -223 cheese standard? Once finalized, will implementation of the cheese CAP 
measure move forward based on Mexico's Quality Infrastructure Law or the law it replaced, the 
Federal Law on Metrology and Standardization? The United States urges Mexico to halt the 
 
44 For previous statements follow the threa d under ID 644 . 
45 For previous statements follow the thread under ID 678 . G/TBT/M/86  
 
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  finalization of the  measure and consider less trade -restrictive alternatives as previously proposed by 
the US Government, other WTO Members, and industry stakeholders.  
2.106.   The representative of Australia  provided the following statement. Australia would like to 
reiterate its con cerns that Mexico's measure notified as G/TBT/N/MEX/465  appears discriminatory 
and more trade restrictive than necessary. Australia recognizes the original objectives of the 
proposed measures and welcomes the review of the procedure in light of Mexico's international 
commitments. W e look forward to receiving Mexico's reply to our comments on its notification. We 
kindly request an update for the release date of the new version of the procedure for public 
consultation.  
2.107.   The representative of the European Union  provided the following statement. The European 
Union would like to join this trade concern and to Mexico for the revised text notified on 8 February, 
which is currently under analysis. According to information from EU industry, some aspects of the 
conform ity assessment procedure (CAP) for the Mexican Official Standard NOM -223-SCFI/SAGARPA -
2018 on cheese would cause difficulties for EU exporters. The EU would like to ask about the state 
of play of the ongoing revision of the measure.  
2.108.   In response, the repres entative of Mexico  provided the following statement. On 8 February, 
Mexico notified a new version of the Conformity Assessment Procedure in document 
G/TBT/N/MEX/465/Rev.1 , with a deadline for submitting comments of 9  April. We therefore invite 
Members to participate in this new public consultation process.  
2.1.3.8   European Union - Draft EU Batteries Regulation (implementation of the European 
Green Deal), G/TBT/N/EU/775  (ID 68546) 
2.109.   The representative of China  provided the following statement. 1. Regarding Article 7 and 
Annex 2, the EU should regulate the car bon footprint after the battery product carbon footprint 
calculation method is unified and should set a scientific and reasonable carbon footprint threshold 
according to the carbon peak and carbon neutral targets of different Members. It is suggested that 
the EU could make public the progress of carbon footprint calculation methodology so that other 
Members could join in the discussion on carbon footprint. Given that China has comprehensive data 
and supply chain on battery sector, China is willing to partic ipate in the development of carbon 
footprint methodology. 2. Regarding Article 8, it is suggested to cancel the "Minimum share of 
recycled content " in the current stage and give it consideration after setting up the methodology of 
the calculation and verif ication for the amount of recycled content. For industrial batteries, electric 
vehicle batteries and automobile batteries, the regulations set the minimum share of cobalt, lead, 
lithium or nickel recycled from waste present in active materials by 2030 and 2035, but the 
methodology for the calculation and verification of the recycled materials will not be set out until the 
end of 2025. China considers that it is unreasonable to require the minimum share of recycled 
materials before clarifying the scientific methodology. In addition, the industry also considers that 
the recycled proportion of cobalt is relatively high. It is suggested to delete the requirement for 
"each batch per manufacturing plant " and modify the requirement to "each battery model ", so as to  
simplify the process. 3. EU should reassess the performance indicators of batteries in terms of 
electro -chemical performance and durability, minimum average duration, health status and life 
expectancy, and set scientifically reasonable performance indicat or requirements according to 
different service conditions of the products.  
2.110.   4. It is suggested that the EU could cancel the disclosure of the technical documents 
containing commercial secrets of enterprises on the premise of meeting the regulatory purpose. 
Some items in article 7, article 8, and appendix 2 are required to provide the technical information, 
but the technical information about the battery content, the material and processing involve some 
core secrets, such as the content of cobalt, nickel, lit hium contained in batteries, and data about 
carbon emissions of materials like electrolyte, and isolation membrane in the process of production, 
which increases the risk of leakage of business secrets of the enterprise. 5. Regarding Article 13 and 
Annex, i t is suggested to clarify the format and position of labels and QR codes. The position of 
labels and QR codes referred in the regulation is not clear as affixing labels and QR codes to cells, 
modules or battery packs. It is suggested to use e -labelling (QR  code) to cover all of the labelling in 
Article 13, instead of requiring physical labelling and QR code at the same time. E -labelling has 
become mainstream in the world, such as the United States, Canada, China, Singapore and many 
 
46 For previous statements follow the thread under ID 685 . G/TBT/M/86  
 
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  other members, they all a llow the use of E -labelling. It is suggested to delete the requirement in 
Part A of Annex VI that the label should reflect the information of "date of placing on the market". 
In fact, when the battery is manufactured, the manufacturers generally don't know  the exact date 
for the batteries to be placed on the market. It is very difficult for manufacturers to provide this 
information.  
2.111.   6. Regarding Article 39, it is suggested to extend the transitional period from 12 months to 
24 months. The content of regulat ion is comprehensive, and the management system would take 
quite a long time, so due diligence needs a long transitional period. 7. The regulation stipulates the 
due diligence scheme of the supply chain in section 72 of Chapter 10. This investigation can b e 
officially authorized by EU to conduct supply chain due diligence in other markets, it is recommended 
that EU should consult with relevant market regulatory authorities of other parties before authorizing 
the supply chain due diligence investigation, and  the investigation can only be carried out if both 
parties agreed. 8. The proposed regulation requires all product batteries can be disassembled and 
replaced by end -users or independent operators, which may greatly influence the design of portable 
electron ic products (such as mobile phones, tablets, etc.), and bring new risks to battery installation. 
Based on the current market situation, EU should add the following contents into the regulatory 
compliance: if portable electronic products batteries are desig ned to be disassembled and replaced 
by a manufacturer -trained or authorized professional service provider , it shall be deemed to meet 
regulatory requirements. 9. Provided that the formal date of entry into force is uncertain and it also 
needs a long time t o complete the general legislative process in the EU. In view of the labelling 
requirements specified in the regulations involve changes in hardware equipment, and the related 
technical documentation also needs time to be prepared, which imposes a great bu rden on 
manufacturers, it is recommended that the EU provides at least 12 months for the transition period 
to the manufacturers.  
2.112.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statements  made during the previous meetings of the Committee on TBT 
with regard to the proposed measure. We appreciate efforts of the EU in the fields of fighting climate 
change and protection of environment. However, we are still concerned with the lack of scienti fic 
data and international standards as a basis for proposed conditions for access to the EU market as 
well as material recovery targets for waste batteries. We urge the EU to conduct its trade -related 
climate policy in compliance with the WTO rules and re levant climate agreements without creating 
obstacles to trade and preserving sufficient level of competition between imports and domestic 
manufacturing.  
2.113.   In response, the representative of the European Union  provided the following statement. 
The EU would li ke to recall that the Batteries Regulation proposal was presented on 10 December 
2020 and notified to the WTO on 26 January 2021 with a commenting period of 90 days. During the 
commenting period, the EU received written comments from China, Japan and Canad a to which the 
EU replied on 18 October 2021. Regarding some of the general issues raised by the Delegation of 
China, the EU would like to remind that batteries are an important source of energy and one of the 
key enablers for sustainable development, gree n 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 
introduct ion of minimum levels of recycled content of cobalt, lead, lithium and nickel in batteries is 
part of the EU's effort to foster the circular economy and have markets for secondary raw materials 
work efficiently. The EU has estimated the availability of suc h materials recovered from waste by 
2030 and 2035 on the basis of the best available evidence and information. The EU has included the 
possibility to adjust the targets in 2027 should trends in availability differ significantly from those 
estimates. The EU  has taken good note of the point raised by China concerning the disclosure of the 
technical documents with commercially sensitive information and will assess this case by case for 
the different provisions of the proposed Regulation. Moreover, the EU would  like to reassure that 
there will be sufficient time to consider the feedback received on the notified draft prior to adoption. 
Implementing and delegated acts that will be developed under the notified draft will involve 
consultation of stakeholders, thoug h the exact way in which this will be done is to be determined in 
each case. Drafts of those implementing measures and delegated acts will be notified to the WTO in 
accordance with the TBT Agreement.  
2.114.   The application dates for some of the provisions in the notified draft are indeed 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, G/TBT/M/86  
 
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  because it will depen d on the time needed for the regulatory process to adopt the notified draft. In 
fact, it is clear that at least some of the application dates need to be reassessed, because the 
regulatory process is still ongoing. The European Parliament will vote this wee k (week 10), and the 
Council is expected to conclude their position next week (week 11). The two will then come together 
to decide on the final Regulation. This process is likely to conclude in the second half of this year. In 
conclusion, the EU stresses t hat 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 the risks that non -fulfilment would create. Regarding Article 
2.1 of 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 complies with 
the provisions of the TBT Agreement.  
2.1.3.9   European Union - Withdrawal of the approval of the active substance alpha -
cypermethrin, G/TBT/N/EU/770  (ID 69447) 
2.115.   The representative of Brazil  provided the following statement. Brazil would like to express 
its concerns related to European notification 770 regarding the Commission Imp lementing 
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, including 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. Alpha -cypermethrin 
is also an important component to conduc t 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 ki ndly 
encourage the EU to adopt MRLs for imported products in accordance with the limits set under the 
Codex Alimentarius.  
2.116.   The representative of Paraguay  expressed support for and solidarity with the people of 
Ukraine, especially colleagues and friends from  the country's representation to the WTO and their 
families, as they go through this difficult time. The WTO was an organization founded on respect for 
international law and, as such, could not  fail to defend the strict observance thereof. The multilateral  
trading system was, and must continue to be, a tool that contributes to peace and stability. In this 
regard, the representative  reiterate d that the Republic of Paraguay condemn ed the attacks on the 
Ukrainian  people, which were in violation of the principles of sovereignty and international law, and 
reiterate d the need to find a mutually acceptable and long -lasting peaceful solution.  
2.117.   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.  Paraguay wishes to reiterate the importance of this 
substance in controlling pests that attack crops of great eco nomic importance to the country, such 
as maize, soybean, sunflower and cotton.  In this regard, Paraguay once again requests that, during 
the review of the MRLs on 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 approach and base its decisions on conclusive scientific evidence 
and real risk weightings, in accordance with international standards and principles.  
2.118.   In response, the representative of the European Union  provided the following statement. As 
explained in the TBT Committee last November, the approval of Alpha -cypermethrin had to be 
withdrawn, as the Commission Implementing Regulation that renewed its approv al 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 ot her deadlines. However, in October 2020, the applicant informed 
 
47 For previous statements follow the thread under ID 694 . G/TBT/M/86  
 
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  the Commission that it would not submit any confirmatory data. Therefore, as the information 
required in accordance with Article 6(f) of Regulation (EC) No 1107/2009 on plant protection 
produc ts was not submitted and the applicant had clearly stated that he will not fulfil his regulatory 
obligations, the approval for Alpha -cypermethrin had to be withdrawn according to Article 21(3) of 
Regulation (EC) No 1107/2009. As regards Maximum Residue Lev els (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 i n the second half of 2022. After that, the EU will consider the outcome and 
follow up on it, if appropriate. 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 and 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 a ccording to Article 6 of Regulation (EC) No 396/2005 
on maximum residue levels of pesticides in or on food and feed of plant and animal origin. 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.  
2.1.3.10   European Union - Chemical strategy for sustainability (implementation of the 
European Green Deal) (ID 69048) 
2.119.   The represen tative of the Russian Federation  provided the following statement. The Russian 
Federation is still concerned with the strategy developed by the EU, which implies potential 
restriction and even prohibition of materials that classified as hazardous ones rega rdless of whether 
the scientific basis for that has been provided or not. We note that the core legal act for classification 
of chemicals and substances of the EU is the CLP Regulation. Currently, this regulation allows to 
make strict classification decisi ons 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 EU CLP Regulation. Such an approach can lead to unjustifiable prohibition of mater ials. 
We urge the EU to implement the strategy in full compliance with the WTO rules and principles.  
2.1.3.11   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 71749) 
2.120.   The representative of the Republic of Korea  provided the following s tatement. Regarding 
India's six Quality Control Orders (QCOs) for Chemical Fibers and Yarns (PSY, IDY, FDY, POY, PSF, 
and SMF50) notified to the WTO on February 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 twice concerning the enforcement dates and improvement of the regulations in August 
2021 and November 2021. Korea appreciates India for granting an additional grace period until April 
2022 in response to our comments so that some of the difficultie s of Korean companies were 
resolved. Korea would like to reiterate several concerns that remain unresolved for Korean 
companies in relation to India's six QCOs.  
2.121.   Firstly, despite the one -time suspension of enforcement by the Indian government, there 
are sti ll some difficulties in appointing a local Indian agent and conducting on -site inspections due 
to the COVID -19 pandemic. Therefore, we request that India provide an additional grace period of 
six months at least. Secondly, there is currently no published i nformation on detailed test procedures 
and where to affix the ISI mark, making compliance with the regulations difficult. Therefore, we 
request that India provide detailed information needed in implementing the regulations. Thirdly, the 
notified BIS regula tions deviate from international practices. Countries such as the United States 
and Germany, operate a unified certification system of which a local laboratory issues the certificates 
after conducting testing. On the other hand, India's regulations require  products to be tested twice, 
once in an on -site inspection and once at a designated testing laboratory, increasing the burden of 
 
48 For previous statements follow the thread under ID 690 . 
49 For previous statements follow the thread under ID 717 . 
50 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 St aple Fibres; 
SMF: Synthetic Micro -Fibres for use in Cement Based Matrix.  G/TBT/M/86  
 
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  certification on the industry. Accordingly, we request that India integrate the product testing 
procedures to tests conducted by laboratories recognized by the BIS and exempt testing during the 
on-site inspection.  
2.122.   Fourthly, among the regulated items, PF POY, FDY and IDY share the same properties and 
raw material composition, only their respective manufacturing process are differe nt. Nevertheless, 
they are classified as separately regulated items, increasing the burden of certification. We request 
that India reclassify these three types of items so they can be regulated as one polyester filament 
item. Lastly, after BIS certificatio n, redundant administrative procedures are performed in the 
process of affixing the ISI mark, resulting in excessive certification costs51 for BIS certification 
compared to other certifications in general. Therefore, after issuing the BIS certificate, we r equest 
that India mitigate the relevant certification procedures, by such as recognizing the BIS certification 
number declared in shipping documents in substitute for ISI mark attachment.52 Your reply on this 
matter would be deeply appreciated.  
2.123.   The represe ntative of the European Union  provided the following statement. The European 
Union (EU) would like to express its support to this trade concern raised by the Republic of Korea. 
The proposed measures require products to be tested twice, including local audi ts and designated 
laboratory tests. This represents 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 prese nt risk to health and safety, as they are subject to a 
detailed testing for safety and quality control in the EU before being exported. Furthermore, the 
notified measures deviate from international standards. There is also a concern expressed by EU 
industr y related to the requirement to submit confidential information such as machinery make and 
ID number, names of raw material suppliers, etc. It would be highly appreciated if the scope of the 
Quality Control Orders is restricted to information related to st andards.  
2.124.   In response, the representative of India provided the following statement. As acknowledged 
in Korea's statement, the issue has mainly been addressed. As this issue is raised again, it has been 
relayed to the capital. Korea will be communicated on receipt of a response from the capital.  
2.1.3.12   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 71453) 
2.125.   The representative of China  provide d the following statement. China had to raise this concern 
again. The draft only targets five Chinese enterprises and identifies Chinese products as security 
threats without the basis of technical standards and measurement, which violates the WTO principle s 
of non -discrimination and transparency. China would like to suggest that the United States could 
make public the progress of making these rules as soon as possible. In this regard, we raise our 
concerns as follows. 1. China suggests revoking the new prov ision 47 CFR 2.903. It prohibits the 
authorization of certain telecommunications equipment and services under provision 47 CFR 
1.50002, but 47 CFR 1.50002 lists only five companies of China, which violates non -discriminatory 
principles in TBT Agreement. 2.  For Section III. A of the draft regulations, it is recommended to 
provide technical standards which could judge the national security threats, and that the FCC shall 
authorize the products that comply with the safety technical standards. The draft regulat ions prohibit 
the authorization of certain telecommunications equipment and services under provision 47 CFR 
1.50002, on account of national security threats. As the technical standard and measurement index 
are not publicized, it is not consistent with WTO/ TBT transparency principles. It is recommended to 
set up technical standards and measurement index, notify WTO and provide at least 60 days for 
Members' comments.  3. For section III.A.3 of the draft regulations, it seeks comments on whether 
to revoke any o f 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. Currently, the 
equipment authorizations that have been previously granted are obtained stri ctly following the then -
 
51 Certification cost per item (USD 24,000) + Annual renewal cost (USD 1,540+marking cost) required, 
Total certification cost of at least 30 million KRW per item.  
52 Currently, Oeko -Tex, REACH, etc. include copies of their certificate in shipping documents or send the 
copies to customers separately.  
53 For previous statements follow the thread under ID 71 4. G/TBT/M/86  
 
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  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 III.A.3.  
2.126.   In response, the representative 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 Program 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 
authori zation 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 250 
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.  
2.1.3.13   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 
70654) 
2.127.   The representative o f the Republic of Korea  provided the following statement. The Republic 
of Korea would like to express its sincere gratitude for China's kind reply to the STC statement raised 
by Korea at the last WTO TBT Committee meeting in November 2021 with regard to Ch ina's draft 
amendment of "National Standard of the P.R.C., Lithium Ion Cells and Batteries Used in Portable 
Electronic Equipment – Safety Technical Specification" (GB 31241 -20XX). Korea fully understands 
China's position that the deletion of the exceptions  clause, which waives cell body marking 
requirements when agreed between manufacturers, was a necessary revision to guarantee the 
traceability, identification and safety of products, because cells without proper identification 
markings have caused confusio n to market regulation in China in recent years. However, if the draft 
amendment is implemented as it is, it would have a severe negative impact on Korea's electrical and 
electronic products industry, so we would like to reiterate our comments once again.  
2.128.   Cells are only parts, and their export destinations are determined only when the cells are 
finally assembled into battery packs or end -products, and most countries, such as the European 
Union, the United States and Japan, set cell body marking exceptions p rovisions in accordance with 
the international standard, IEC 61960 -3. Therefore, it is difficult to provide a separate cell body 
marking procedure solely for products to be exported to China. In order to comply with China's cell 
body marking requirements, replacement of production facilities and rework of existing products 
must be made, which will be quite costly and time -consuming, laying an excessive burden on 
relevant manufacturers. Korea requests that China maintains the exceptions regarding cell body 
marking requirements in consideration of these difficulties in the industry. If the amendment must 
inevitably be implemented without modification, 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.  
2.129.   In response, the representative of China  provided the following statement. The identification 
is very important for the safe use of cells and batteries. As an important component of a battery, 
cells cannot be traced or identified effectively without necessary identification information. Cells 
without identification have caused much confusion in market regulation in recent years. Therefore, 
through investigation and extensive consultation during the formulati on, GB 31241 -20xx proposed 
relevant requirements for cell body identification. China will not consider deleting exceptions.  
 
54 For previous statements follow the thread under ID 706 . G/TBT/M/86  
 
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  2.1.3.14   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629 , G/TBT/N/EU/826  (ID 53955) 
2.130.   The representative of Brazil  provided the following statement. In August, 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 and Packagin g 
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 ou t, 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 t ime, 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 the 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 (also called "read-across ") with the substance valproic acid.  
2.131.   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 
thus, will revea l 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 information to su pport 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 cl aimed 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, according t o 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 substance, 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. We also appreciate the 
written reply to the comments from our private sector in the public consultation. In this sense, we 
would like to ask if the EU could provide an update o n the status of the proposal, regarding the 
current and next steps of the process towards adoption and entry into force.  
2.132.   The representative of the Russian Federation  did not make a statement during the meeting. 
A technical statement was circulated followin g the meeting.56  
2.133.   In response, the representative of the European Union  provided the following statement. 
The European Union would like to thank Brazil for raising this issue and for the written comments 
concerning the classification of the 2 -ethilhexanoic  acid (2 -EHA) in the 18th adaption to technical 
and scientific progress (ATP) of the Classification Labelling and Packaging (CLP) Regulation.57 The 
EU notes that the written reply to the comments of Brazil was sent shortly after the last TBT 
Committee, on 25 November 2022. Therefore, the EU would like to reiterate the main points and 
refer to the written reply for details. The EU would like to note that the draft 18th adaption to 
technical and scientific progress (ATP) of the Classification Labelling and Pa ckaging (CLP) Regulation 
was presented for a final consultation at the meeting of Competent Authorities on REACH and CLP 
(CARACAL) on 19 October 2021. Based on that consultation, as well as on all previously received 
comments, including comments from WTO M embers, 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. The two months objection period for the European 
 
55 For previous statements follow the thread under ID 539 . 
56 G/TBT/W/769 . 
57 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/EN/TXT/?uri=CELEX%3A02008R1 272-20211001 . G/TBT/M/86  
 
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  Parliament and the Counc il is ongoing and if there are no objections, the measure should be 
published in the EU Official Journal in the second half of April.  
2.134.   The proposed classification of 2 -EHA is based on the scientific opinion of the Risk Assessment 
Committee (RAC) of the Euro pean Chemicals Agency (ECHA), which assesses all reliable and 
adequate scientific evidence that is available. In June 2020, the RAC concluded that 2 -EHA should 
be classified as toxic to reproduction, Category 1B for development. RAC reaches its conclusions  by 
applying the classification criteria in Annex I of the CLP Regulation, which are fully aligned with the 
corresponding classification criteria for reproductive toxicity under the Globally Harmonized System 
of Classification and Labelling of Chemicals (G HS). These criteria also stipulate that an evaluation of 
substances chemically related to the material under study may also be included. The relevant section 
of the RAC opinion describes the available evidence from studies carried out with the substance 2 -
EHA itself and complements it with information on valproic acid. RAC considered valproic acid a 
substance related to 2 -EHA not only based on structural similarity, but also on a similar 
developmental toxicity profile in animal studies. The EU can therefore  not agree with the argument 
in the comments submitted by Brazil that RAC based its conclusion solely on a read -across from 
valproic acid instead of considering information on 2 -EHA itself, and considers that the assessment 
carried out by RAC and the concl usions that were drawn were fully compliant with the classification 
criteria of the CLP Regulation and GHS. The EU hopes that these responses sufficiently clarify the 
points raised.  
2.1.3.15   European Union - Transitional periods for MRLs and international consultat ions 
(ID 58058) 
2.135.   The representative of Colombia  provided the following statement. Colombia reiterates its 
grave concern regarding the international consultation procedures adopted by the European Union 
(EU) and the transition periods granted prior to the en try into force of provisions under which the 
EU does not approve the marketing of certain plant protection substances and amends maximum 
residue levels (MRLs).  These concerns are being reiterated because the EU has so far not responded 
to any of the reques ts concerning the granting of longer transition periods and has not taken into 
consideration the comments made during international consultation periods.  We reiterate that there 
are no alternatives that would help to resolve the problems and uncertainty th at short transition 
periods cause for fruit - and vegetable -producing countries. These measures 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 a rrives on the European market . This is particularly 
complex for products with long production and harvest cycles, as well as for processed and frozen 
foods.  
2.136.   Furthermore, Colombia maintains that notification to the WTO of non -renewal, the MRLs to 
be applied  and transition periods should not be made by the EU as a simple formality within the 
regulatory process. We recall that the notification must be submitted within a time frame that allows 
the Members concerned to submit substantive observations and comment s for genuine consideration 
by whoever is developing the technical regulation.  Within the framework of this Committee, it cannot 
be acceptable for the EU to state that, as soon as the European Food Safety Authority (EFSA) 
recommendation is known, countries  should be able to "make the relevant adjustments", given that 
the WTO must first be notified of this information and the public consultation period must be held.  
On this occasion, we would like to ask the EU some specific questions. How are the comments 
submitted by countries taken into account? What is the procedure for analysing the technical and 
scientific information submitted during the public consultation period? In what cases have changes 
or modifications been made to the EU standards on MRLs on the  basis of comments made during 
public consultations?  We invite the EU to follow the recommendations of good regulatory practices, 
under which standards must be based on clear and objective information and on the promotion of 
open dialogue with stakeholders . 
2.137.   The representative of the United States  provided the following statement. We continue to 
raise our concern about the European Union's (EU) transitional measures for pesticide maximum 
residue levels (MRLs). We repeat our request that the EU extend transit ion periods 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. We recall longstanding 
concerns that trading partners d o not know with certainty what the impact of the EU's active 
 
58 For previous statements follow the thread under ID 580 . G/TBT/M/86  
 
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  substance nonrenewal decisions will be on future MRLs. We seek confirmation that the EU will allow 
for longer, more reasonable transition times for MRLs where the EU has not identified risk to 
consumers based on dietary exposure. We would have some serious trade concerns if MRLs and 
import tolerances are lowered or withdrawn, subsequent to an active substance non -approval or 
restricted approval decision, in a manner that is disproportionate to the  level of risk to human health, 
and which appears more trade restrictive than necessary.  
2.138.   In addition, we reiterate our concern about the EU's consideration of import tolerance 
applications. Our past experience indicates that the review of additional data i s often only considered 
after the EU notifies its intent to issue a nonrenewal notice. Once again, the United States reiterates 
its request that the EU retain existing MRL levels while import tolerances are under consideration, 
and that the EU fully comple tes science -based risk assessments prior to setting new 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 themselves 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 pro duction could face rejection at EU 
borders. EU growers do not face the same timelines 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.  
2.139.   The representative of Uruguay  provided the following statement. In view of harvesting 
periods, the stages at which plant protection products are applied, and the time 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 p roducts, comply with the new, lower MRLs. Like other 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 production 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 strictly necessary to depart from these standards in 
order to meet their legitimate objectives, as provided for in the relevant WTO  Agreements.  Even in 
cases where the European  Union decides, based on a full  risk assessment, that it is necessary to 
reduce the MRLs for active substances used in the agricultural production of other Members, we 
encourage it to take into consideration the need to grant transitional periods that are adequately 
and sufficiently lon g to make the relevant adjustments.  
2.140.   The representative 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 item. We 
respectfully bring to the attent ion of the EU its obligations under Article 2.12 of the TBT Agreement, 
which relate to the establishment of a reasonable interval between the publication of technical 
regulations and their entry into force, except in cases of urgent problems of safety, hea lth, 
environmental protection or national security. It is of utmost importance that the EU provides 
adequate transitional periods, especially for those cases in which the scientific opinions of the EFSA 
on the toxicity of substances are "inconclusive" or o nly 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.  
2.141.   The representative of Canada  provided the following st atement. Canada would like to 
reiterate its concern with the EU's approach to transition periods for maximum residue limits. In our 
view, the rapid deletion of MRLs and import tolerances for substances no longer approved in the EU 
seems disproportionate to  the level of risk to human health and is more trade -restrictive than 
necessary. Canada reminds the EU of the reality of agricultural supply chains, including multi -year 
inventory and the extensive shelf lives of products. The current transition periods ma ke it very 
difficult for exporters to adapt to the new requirements given the distance travelled from the source. 
Transition periods of one year, particularly where there are no dietary risks of concern, allow trade 
to continue uninterrupted, while providi ng sufficient time for producers and exporters to adapt to 
new EU requirements. The EU has found a way to accommodate the need of its domestic G/TBT/M/86  
 
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  stakeholders to ensure food security and minimal food waste through the use of emergency 
authorizations. Noting t he important role of trade in achieving these goals, Canada urges the EU to 
extend the transition periods for MRLs on imported goods to allow agricultural supply chains the 
time to adapt to new requirements.  
2.142.   The representative of Costa Rica  provided the fo llowing statement. We reiterate our support 
for the concern, as in previous meetings, as well for the request to extend the period of compliance 
with the new tolerances that are being established for various substances, in view of the serious 
impact they h ave on agricultural production in our countries.  It is impossible for agricultural 
production in Costa Rica to adjust to new requirements or tolerances within the period established, 
when the registration of new molecules alone entails a complex assessment  process lasting over six 
months. This relates to the European Union's process to revise the tolerances for different substances 
used in agricultural production.  In the current historical context in which the international community 
finds itself owing to the COVID -19 crisis, the implementation of more restrictive measures or 
additional burdens on international trade in agricultural products constitutes a challenge that is 
hampering worldwide economic recovery efforts, especially in developing countries. In  this regard, 
we would like to remind the EU of the request made in documents G/SPS/GEN/1778  and 
G/TBT/GEN/296  - Request for the Suspension of the Processes and Entry into Force of Reductions 
of Maximum Residue Levels (MRLs) for Plant Protection Products in light of the COVID -19 Pandemic.  
2.143.   The representative of Paraguay  provided the following statement. As with other similar 
concerns, we are concerned 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 t he TBT 
Agreement.  Similarly, the reduction of MRLs, on the basis of the argument that 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 id entified certain substances as being safe, is not 
in line with Members' obligations under the SPS Agreement.  The pursuance of such policies will cause 
significant trade damage to the economies of developing countries and jeopardize their ability to 
achieve  sustainable development goals, including those related to food security.  We urge the EU to: 
reassess its approach; base its decisions on conclusive scientific 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 processes and geographical locations, including distances, of its trading partners, as 
the six -month per iod is insufficient for adapting productive systems.  
2.144.   The representative of Ecuador  provided the following statement. Ecuador is extremely 
concerned about 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 reduction of tolerances. In 
order to establish reasonable transition periods, it is necessary to consider harvesting periods and 
the times when agrochemicals are applied.  Farmers in all countries, and partic ularly 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.  Ecuador is aware that the EU allows 
its farmers to request emergency authorizatio ns so that, in certain particular situations, they can 
use active substances that have already been banned in the European market. For Ecuador, it is 
important to know whether, where emergency authorizations are issued for the use of such 
substances, EU me mber countries have notified and justified the application of MRLs that differ from 
those established in the EU's existing MRL regulations. We would also like to know how the EU 
monitors whether the member State that has received an emergency authorization  for the use of 
prohibited substances is complying with the existing MRL regulations and how it verifies, in the case 
of non -compliance with the MRL regulations, that the products containing the prohibited substances 
have not been marketed in other EU memb er States.  
2.145.   The representative of Guatemala  provided the following statement. The importance of 
establishing transitional periods that closely follow the stages of crop production was reiterated 
following the lowering of maximum residue levels (MRLs) notifi ed by the European Union.  In 
particular, more time is required for the adaptation of crops grown in tropical countries, and to find 
alternative substances, which in some cases means having to wait for suitable production cycles to 
commence application and testing. As a result, the six -month period that the European Union 
considers to be the time required to make technical changes to agriculture is not feasible.  We 
reiterate our concern that our ideas for focused discussions on finding solutions have not bee n heard 
and accepted. We support the questions raised by Colombia and look forward to the European 
Union's replies.  G/TBT/M/86  
 
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  2.146.   The representative  of Chile provided the following statement. The delegation of Chile is 
pleased to comment on the STC recently raised in re lation to the tolerances being set by the EU for 
different plant protection substances, which affect Chile's foreign trade in agricultural products.  
2.147.   The representative of Panama  provided the following statement. L ike the delegations that 
took the floor before us, we express our deep concern over the transitional periods for MRLs. We 
urge the EU to provide a reasonable transitional period to allow industry to adapt to these changes.  
2.148.   In response, the representative of the European Union  provided the following statement. 
The EU has provided detailed information on transitional periods for Maximum Residue Levels (MRLs) 
at previous TBT Committees, in particular, at the TBT Committee meeting in May 2020. The EU 
considers concerns on the setting of Maximum  Residue Levels (MRLs) for pesticides – and any details 
regarding their implementation – to be an issue for discussion at the SPS Committee, rather than at 
the TBT Committee. 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. However, in the interest of 
transparency and, further to requests by some Members, when notifying  these measures under the 
WTO/TBT notification system, the EU additionally informs the SPS Committee of the submission of 
those notifications on pesticide active substances. In practice, both Committees are informed about 
draft acts on the non -approval or restriction of approval of an active substance in the EU. However, 
comments should only be submitted via the TBT notification system. The European Union would like 
to point out in this context that the commenting deadlines are always respected and that the  
comments received within those deadlines are duly taken into account in the EU's decision -making 
process.  
2.149.   In the interest of efficient proceedings in both Committees and, in line with the respective 
Agreements, matters on approvals of active substances should be discussed exclusively in the TBT 
Committee, while matters on the setting of MRLs for pesticides sho uld be discussed exclusively in 
the SPS Committee. The EU therefore kindly invites Members not to raise issues concerning 
transitional periods for MRLs at the TBT Committee. As regards the joint Request for the suspension 
of the processes and entry into fo rce of reduction of Maximum Residue Levels (MRLs) of plant 
protection products in light of the COVID -19 pandemic in documents G/SPS/GEN/1778  and 
G/TBT/GEN/296  and subsequent revisions, the EU position is included in the document of 28 May 
2021 with double reference G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315  circulated in both 
Committees.  
2.1.3.16   China - Draft Administra tive Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61159) 
2.150.   The representative of Canada  provided the following statement. Canada remains concerned 
that China's recently implemented administrative measures for the registration of overseas 
manufacturers of imported food negatively impacts trade. Over the years, Canada and China have 
implemented many bilateral arrangements that have successfully maintained the safe trade in food 
between our respective nations. However, Canada continues to be c oncerned that the administrative 
measures being implemented by China 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 remains disappointed that Decree 248 was adopted and published by the General 
Administration of Customs of the People's Republic of China (Customs China) immediately following 
the comment deadline without sufficiently taking into account comments and concerns from WTO 
Members. More over, Canada is disappointed that China went ahead with implementation of Decree 
248 on 1 January 2022, and did not heed the requests of many WTO Members to delay 
implementation for 18 months to allow additional time for competent authorities and industry to 
understand and comply with these new requirements. With the recent implementation of Decree 
248 and the launch of the online China Import Food Enterprise Registration (CIFER) system, Canada 
is deeply troubled by the serious barriers to trade these measu res are creating, including significant 
financial and resource impacts on both industry and foreign competent authorities.  
2.151.   Canada would like to emphasize that the implementation of the CIFER system was 
unexpected by trading partners, and this system was no t included in the proposed measure notified 
by China in G/TBT/N/CHN/1522 . Canada is therefore disappointed that China did not inform or 
 
59 For previous statements follow the thread under ID 611 . G/TBT/M/86  
 
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  engage with trading partners prior to the implementation of CIFER, nor did China provide a 
reasonable transition period for competent authoritie s and industry stakeholders to adapt to this 
new system. Prior engagement would have limited disruptions to trade and addressed the concerns 
currently being raised by competent authorities and industry stakeholders. Despite repeated 
requests from trading p artners, there remains limited engagement, information, and guidance from 
Customs China regarding the implementation of the CIFER system, which is resulting in continued 
uncertainty and increasing concerns. As well, industry has faced delayed clearance of shipments due 
to this new system. For example, Canada notes that there is insufficient information and guidance 
from China to undertake and complete the process to register medium risk establishments that 
inadvertently missed the October 2021 deadline. The  registration process is overly detailed and 
confusing, lacking the step -by-step process and defined timelines for both competent authorities 
and industry. This is creating unnecessary barriers to trade and adding pressures to exports on 
commodities that w ere previously eligible to export from accessing the Chinese market.  
2.152.   As a result, Canada immediately requests that China provide, without undue delay, a grace 
period of 18 months for medium risk commodities during which the establishment information in 
CIFER will not be used by Chinese border officials to determine export eligibility. This grace period 
would extend until 1 July 2023, and apply to: (i) all the companies that were eligible to export to 
China as of 31 December 2021, and (ii) the companies curr ently registered in CIFER. Canada 
stresses that this grace period is needed to afford companies sufficient time to register and/or amend 
their registrations. Additionally, Canada notes that we continue to expect China to add to the CIFER 
system, without un due delay, all approved Canadian establishments that were approved by China, 
but had not yet been included in the list of approved Canadian products and facilities eligible to 
export to China. As many questions remain regarding the registration process fro m both industry 
stakeholders and foreign competent authorities, Canada urges China to create a contact point for all 
queries from both industry and competent authorities. If this is not possible, then Canada calls on 
China to work directly with companies f or the completion of their registrations. Canada underscores 
that trade disruptions will continue if detailed guidance is not adequately provided and all associated 
timelines are not clearly explained and defined. Canada strongly urges China to outline all  timelines 
in a transparent manner and develop clear guidance documents to address the questions and 
concerns from both industry and competent authorities. In conclusion, Canada remains deeply 
concerned about the impact these measures have on trade. These measures have resulted in 
resource pressure and confusion for competent authorities and industry due to the lack of details 
and transparency from China regarding the implementation of these new requirements.  
2.153.   The representative of Indonesia  provided the fol lowing statement. Indonesia thanks China 
for its prompt responses as well as the mechanism carried out in the progress of registering 
Indonesia to enable business actors continue distributing their products in China. Indonesia fully 
respects the rights of China's authority to protect the health and safety of its people by ensuring the 
safety aspects of food products consumed in China's market. Indonesia plays a significant role in 
contributing China's food supply, including the provision of food raw materia ls needed by the Chinese 
market, and committed to continue doing that. For this reason, Indonesia hopes that this policy will 
not disturb Indonesia's export process to China. Indonesia recognizes that a registration process is 
necessary to ensure effective  supervision of products circulating in China and compliance to 
occupational safety, health & environmental protection. However, the implementation of this policy 
has inevitably created obstacles for our industry. Thus, we require further clarification on the 
following matters to rationalise the food product registration process. Indonesia requests 
explanations and guidelines regarding the compatibility of the Harmonized System (HS) Code with 
the CIQ Code considering that the CIQ Code is specific only to Ch ina, while HS code is already 
available as the common system for international trade. Indonesia requests China to provide 
complete guidelines for using the website https://cifer.singlewindow.cn/ . In addition, we expect 
China authorities to make improvements to the website to clarify the difficulties experienced by 
business actors regarding: The registration submission page on the web always displays each field 
with a blank condition, particularly on the homepag e of the basic information menu, production -
related information, checklist and statement, and for attachment information cannot be accessed 
for data input and document upload. This happens either on self -registration or by a competent 
authority. The additi on of menus /features on the GACC website is done without notice and cannot 
be used according to its initial purpose.  
2.154.   Indonesia requests China to clarify the time/timeline of the registration process. Indonesia 
request China to provide a contact point/cont act person who can provide quick response in handling 
the registration process. Indonesia hopes China would consider a relaxation in the implementation G/TBT/M/86  
 
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  of registration to prevent major losses for business actors exporting to China, as is currently being 
experienced by several Indonesian business actors who have been affected by the demurrage. China 
has been a valued and strategic trading partner for Indonesia for a broad range of products, including 
food and beverages. Indonesia wishes to continue becoming a strategic trading partner to China and 
fervently hopes that China reconsiders the timing for the implementation of this measure. Indonesia 
awaits China's response and looks forward to bilateral discussion on this prominent matter.  
2.155.   The representative 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, the Separate Customs Territory of Taiwan, Penghu, Kinm en 
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 and operational guidelin es on how to follow the requirements 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 sufficient 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 contact 
directly with concerns about the online registration sys tem. 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. Second, there are also concerns over 
the measure's review and a pproval 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 explanation, while others cannot correct their application in the r egistration 
system.  
2.156.   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, upon 
request, the applicant is informed of the stage of the pr ocedure. 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 of 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 customs clearance suspension for no reason. Ever since China ma de 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 registrat ion. 
2.157.   The representative of Australia  provided the following statement. 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 acknowledges China's recent 
implementation of measures under its Regulation on Registration and Administration of Overseas 
Manufacturers of Imported Food (Decree 248). While some implementation issues are to be 
expected, Australia remains concer ned about a number of issues and delays surrounding the 
registration of food producers within China's registration systems. In particular, Australia has in good 
faith provided information for registration of establishments that has not been accurately refl ected 
in China's registration system. This is causing significant industry concern and, for some 
commodities, is trade restrictive. Similarly, the difficulty Australian businesses and competent 
authority are experiencing in effecting changes to the Austral ian facility registration on the CIFER 
system (E -Government Platform for the Origin of China's Imports) are causing delays in the 
clearance of product at point of entry. In light of the above, Australia respectfully requests that 
China adapt a flexible app roach to implementation until 1 July 2023, during which they would allow 
entry of products in line with historical trade, in addition to entry under China's new system of 
registration, pending completion of outstanding applications, corrections or updates to online 
registrations.  
2.158.   Australia notes that China is still managing the transition to the new measures and updates 
to China's registration systems are occurring sporadically. Australia would like to request that China G/TBT/M/86  
 
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  meets its obligations to provide Mem bers with transparent timeframes for updates and appropriate 
guidance to minimise disruptions to trade and confusion at the border. Australia suggests that it 
would be valuable for China to provide information to trading partners, for example through an 
information session, and directly to registered facilities through assigned GACC (General 
Administration of China Customs) contact points to assist with resolving issues. Australia reminds 
China that its regulations must not be used to discriminate against i mported 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 
appreciate China's transparency on timeframes for processing these applications, in line with its 
obligations. Australia urges China to address these issues promptly and remains willing to work with 
China to minimise trade disruptions.  
2.159.   The representative of Brazil  provided the following sta tement. 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 a nalysis 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 Compete nt National 
Authority for a much wider range of products. In April 2021, the General Administration of Customs 
of China (GACC) published Decrees n. 248 and 249, which deal, respectively, with administration of 
registration of foreign establishments and man agement of the safety of imported and exported food. 
Article 7 of Decree n. 248 defines the products for which registration will require the recommendation 
of the Competent National Authorities. Could the Chinese side specify the Harmonized System (HS) 
codes for the foods covered in this article?  
2.160.   Article 5 of Decree n. 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 how and when it intend s 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 "? The Brazilian private sector also expressed concern with the packaging r equirements 
contained in Article 15 of Decree n. 248. Could China provide a longer adaptation period for labelling 
requirements? If there are delays in the issuance of the registration number by the GACC, will the 
Chinese government allow for the importati on of products without marking the registration number? 
Considering the need for label design and printing, will the Chinese Government  publish in advance 
additional labelling requirements such as font size and colour, format, visibility, placement and use  
of stickers? Finally, as Decrees 248 and 249 came into force in the beginning of this year, we would 
like to highlight that our national health authority has been experiencing difficulties in using the 
system to make its recommendations as a competent nat ional authority. Would it be possible to 
grant a longer period of adaptation?  
2.161.   The representative of the European Union  provided the following statement. The EU would 
like to express its concerns regarding the implementation of Decree 248 of the Chinese Cus toms 
Administration, which entered into force on 1 January 2022. The EU does not question the right of 
China to ensure that imported food products come from legitimate sources; we share and support 
this objective. However, problems persist with the registr ation of exporting businesses. The EU urges 
China to: allow registered facilities to export any related product for a period of 18 months, 
regardless if it is registered for that particular HS code; maintain an open dialogue to solve 
implementation issues in a pragmatic way; facilitate new registrations by providing supporting 
material and guidance documents in English; and facilitate amendments/corrections to existing 
registrations. The EU would like to thank China for its constructive dialogues on Decree 248 but 
underlines the importance of solving the implementation issues in order to reduce disruptions to 
trade.  
2.162.   The representative of the United States  provided the following statement. The United States 
notes that China implemented this measure, published  as Decree 248, on 1 January 2022. We 
remain concerned with such a trade -impacting regulation, and question the food safety and public 
health benefits, and whether such benefits are based on science or risk. In particular, we are very 
concerned that this m easure now requires our competent authorities to take on administrative 
functions to assist certain US facilities to register via China's online single window portal, and manage 
their access to this portal. Such administrative actions are fundamentally the  responsibility of China's 
domestic food safety regulators. To be specific, it is not the responsibility of US competent authorities 
to administer China's new online registration system. Thus, we request that Chinese competent G/TBT/M/86  
 
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  authorities either communicat e directly with exporting facilities or allow these facilities to self -
register via China's online single window portal, as many other types of facilities are permitted to 
do.  
2.163.   In addition, we note that there are a number of unanswered questions and points  of 
clarification regarding Decree 248. China has only provided some limited guidance, and much more 
is needed. China's insufficient guidance and haphazard implementation of Decree 248 is causing 
trade disruptions and considerable confusion for US manufact urers and competent authorities. For 
example, our industry has reported shipments being held up at ports in China due to erroneous or 
missing information in China's online system that cannot be readily added or revised. Specifically, 
concerns include missi ng or erroneous harmonized tariff (HS) codes in the system, duplicate facility 
registrations, as well as many other concerns. None of these administrative problems can be 
remedied by US Government authorities and must be resolved by the relevant Chinese au thorities. 
Meanwhile, US companies accumulate demurrage and other port fees while they await action by 
Chinese authorities to release the shipments. As we have noted before, any measure of this 
magnitude requires significant implementation time for produce rs, exporters, and competent 
authorities. Therefore, we ask that China allow trade to continue to be unaffected by this measure 
for a period of 18 months to allow for sufficient guidance from the Chinese authorities, including 
addressing the concerns and q uestions by exporting countries. We also ask that China administer 
its new registration system without requiring foreign competent authorities to act as intermediaries 
between China and exporters; and we request time for companies to properly register with  China's 
single window and make any necessary corrections to their information in the system.  
2.164.   The representative of Japan  provided the following statement. Japan shares the concerns 
with other Members on China 's regulation on the Decree 248.  Japan understands China 's efforts to 
enforce the Decree 248 as announced. However, the lead time for the enforcement seemed to be 
too short and the scope and procedure of the registration have been frequently changed, which  
caused confusion and lack of transparency for manufacturers that exported  their commodities to 
China.  In concrete terms, firstly, it is unclear what kind of information is required for the registration. 
For example, though Article 10 lists the information  required for the registration, GACC 's CIFER 
system requires the HS code and CIQ code for the registration, which are not listed in Article 10.  
Secondly, the scope of Decree 248 is unclear. GACC frequently changes the list of commodities that 
require the registration of the facility to be produced.  This means that the border of the scope 
between the registration under Article 7, registration by the Government, and the registration under 
Article 9, the registration by private entities, is frequently changi ng. Moreover, related to the first 
problem, the HS code and CIQ code are sometimes deleted in CIFER system without notice when 
the application under Article 7 is transcribed to the application under Article 9 or vice versa. These 
problems also create unnec essary obstacles to trade. We hear that when each commodity is exported 
to China, Customs Office checks not only whether the commodity comes from registered facility but 
also whether the commodity matches with Chinese HS code and CIQ code that were input a t the 
time of registration.  
2.165.   The problem is that the current CIFER system does not accept the application to add or 
modify the HS code and CIQ code to the already registered facility. So when a commodity comes to 
fall within the scope of Decree 248 due to the change of the scope after the registration of the 
facility, the exporter has no means to export the commodity in accordance with the Decree 248 due 
to the lack of renewal process of the original registration.  Another case that shows lack of 
transparenc y is that though Article 2 of Decree 248 stipulates that the scope of the Decree is the 
registration of the facilities that manufacture, process or store food , GACC recently required an 
exporter to register the fishing vessel that has no processing nor sto rage equipment.  Lack of 
transparency creates unforeseeability of the trade with China. We suggest that China take account 
of the comments and concerns from the WTO Members. Japan also requests China to allow imports 
from registered facilities regardless o f registered commodities till 1 July 2023, as a grace period for 
CIFER system to work smoothly enough for manufacturers to complete registration without stress 
or confusion. Japan suggests China to set contact points for exporters to communicate with GACC 
directly and correct their already registered information by themselves.  
2.166.   The representative of Turkey  provided the following statement. Turkey reiterates its support  
to Members that have raised this issue to the agenda. Although the requirements requested from 
our competent authorities regarding the fulfilment of the Draft Administrative Measures for 
Registration of Overseas Producers of Imported Foods of China have been completed so far, this 
regulation imposes a great burden on both the exporters and the competent authorities of the G/TBT/M/86  
 
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  exporting countries especially considering the complexity of the new system of registration process. 
We consider that Decree 248 covers a wide range of food items, and the implementation of the 
Decree need further clarification s. 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. Turkey believes that this aforementioned regulation restricts trade more than n ecessary. 
Therefore, Turkey would like to ask China to review this legislation from a risk -based perspective 
and narrow its scope of products, in addition to extend the adoption period for this regulation.  
2.167.   The representative of the Republic of Korea  provid ed the following statement. As in the 
previous TBT Committee meetings, the Republic of Korea continues to share the concern raised by 
the delegations of the United States of America, Chinese Taipei, the European Union, Brazil, 
Australia, Indonesia, and Can ada, regarding China's Administrative Measures for Registration of 
Overseas Products of Imported Foods. Korea respects China's right to ensure food safety and 
recognizes its efforts to accommodate concerns that were raised by Member states before the 
Admin istrative Measure entered into force this year. However, Korea remains concerned as our 
requests has not been duly addressed by China and therefore repeat our request. First, we request 
China to provide rationale on the Administrative Measure, in particula r, Article 7 of Decree 248 which 
expands its coverage to low -risk products. Moreover, Korea would like to ask China to share the 
scientific data or risk analysis used to select the 14 categories that requires confirmation of 
conformity from competent autho rities. Korea believes food safety is a legitimate objective under 
the TBT Agreement but its implementing measures shall not be more trade -restrictive than 
necessary.  
2.168.   Second, competent authorities are already experiencing heavy administrative burden, 
havin g to review registration applications of overseas producers, and to confirm they are in 
continuous compliance with China's regulations and standards after registration. Furthermore, 
China's new online registration system was not fully operated, which led t o several confusions such 
as incorrect information, mismatched products, etc. We therefore recommend China to work directly 
with overseas facilities for the application process, rather than involving competent authorities. We 
also request China to designat e a contact point for effective communication and to correct 
information in the registration applications. Korea believes this will save time and money for not 
only China but also overseas facilities and authorities. With respect to this, Korea would like to ask 
China to provide a time frame of the whole registration and compliance process to increase certainty 
and predictability. As China is a very important trade partner to Korea, being the 2nd largest market 
for Korean food products, changes in China's r egulations significantly impact bilateral trade. 
Therefore, Korea requests China to address our concerns and will wait for China's response.  
2.169.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to Decree 248, notif ied to the Members of this Committee on 16  November  2020 in 
document  G/TBT/N/CHN/1522 and which entered into force on 1  January  2022.  While the 
Government of Mexico has established coordinated mechanisms to ensure that the registration of 
Mexican companies  exporting to China can be carried out in a satisfactory manner to avoid delays 
to export processes, we consider it of great importance that the relevant authorities in China commit 
to ensuring that this new scheme does not lead to delays for products that  fully comply with the 
requirements established for importation to that country.  The delegation of Mexico thanks the 
delegation of China for giving its consideration to this statement and reiterates the importance of 
ensuring that the measures adopted by M embers of this Committee are aligned with international 
commitments and do not have the effect of creating unnecessary technical barriers to trade.  
2.170.   The representative of Switzerland  provided the following statement. Switzerland shares – 
and supports - the concerns expressed by other Members regarding the two decrees 248 and 249 
published by the General Administration of Customs of the People's Republic of China (GACC). 
Switzerland understands and supports China's objective to ensure that only safe food is i mported. 
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. Switzerland encourages China 
to brief all interested WTO Members on the implementing rules at the earliest possible date. It is 
important that we all have access to the same information, which can be shared with competent 
authorities and  the industry. Switzerland also encourages China to provide a contact point at GACC 
for facilities in order to allow them to contact GACC directly in case of concerns about the online 
registration system. Furthermore, Switzerland invites China to allow ent ry of all products from G/TBT/M/86  
 
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  registered facilities until 1 July 2023. This additional time would enable facilities to accurately enter 
or update product information in their online registration.  
2.171.   The representative of India supported concerns raised on this STC.   
2.172.   The representative of Chile provided the following statement. The delegation of Chile thanks 
the Chair for the opportunity to support the trade concern raised by the United States, Canada, 
Australia, the European Union, Brazil, Japan, Indonesia and Chine se Taipei, and supported in the 
room by the delegations have already taken the floor. The measure notified by China, on which Chile 
has made timely comments, has entered into force and has created complications for both Chilean 
food-exporting companies and  the competent authorities.  The delegation of Chile recognizes food 
safety as a legitimate policy objective to be pursued, but this should not be done by using measures 
that restrict international trade more than necessary. My delegation is concerned by th e 
implementation of the notified regulations, as there are deficiencies in the registration system that 
make it difficult or, in some cases, impossible to register production establishments that export to 
China on a regular basis. In some cases, this has l ed to unnecessary delays in the shipment of 
products that meet the sanitary requirements for entry to China.  Regarding this measure, the 
delegation of Chile requests that the requirement for mandatory registration be postponed in order 
to avoid interruptin g the current flow of trade.  A number of Chile's registration application processes 
are currently suspended owing to malfunctions in the GACC -administered IT system; there is no 
definite timeframe for the resolution of these issues, which creates uncertain ty and delays to 
shipments that have already been promised.  
2.173.   In response, the representative of China  provided the following statement. 1. The revision 
of the Draft administrative measure for registration of overseas producers of imported foods follows 
the principles of open, transparent, and complies with international rules and common practices. In 
order to effectively implement the Food Safety Law and its implementation regulations, the GACC 
has revised the above -mentioned administrative measure for registration, which was publicized on 
12 April 2021, and came into force on 1 January 2022. We have notif ied the measure to the WTO, 
and adopted reasonable comments. Besides, the transitional period is in line with the requirements 
in the TBT/SPS Agreement. 2. While strengthening food safety supervision, trade facilitation is fully 
considered in this measure.  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 18 categories.  
2.174.   3. Preparation works carried out before the implementation of the regulation. To ensure 
smooth implementation, GACC has issued the interpretation of the rules, the guide for registration 
applications, supporting documents and forms for registration applications, and the operation 
manual for the registration information system. In September 2021, GACC contacted Members who 
exported food to China, inform ed the relevant requirements and procedures for the registration of 
overseas enterprises, and made reasonable arrangements to speed up the auditing process. By the 
end of 2021, the GACC has held video conferences with 114 Members, conducted training for mo re 
than 2,000 overseas enterprises, and answered various questions raised by Members. 4. Since the 
implementation of the regulations, as of 25 February 2022, more than 100 Members have provided 
the list of enterprises recommended for registration, a total of 64,036 overseas manufacturers 
engaged in 31 food categories are registered. So far, implementation of this measure goes well.  
2.1.3.17   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA (ID 61860) 
2.175.   The representative of Colombia  provided the following statement. Colombia thanks Peru for 
its consideration of the concern regarding the use of adhesive advertising warning labels under 
paragraph 8.3 of section 8 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 
018-2021-SA simply extends the deadline for the use of adhesive labels to 31  March  2022; this will 
very soon expire and has created significant uncertainty for business owners and trade ope rators.  
Colombia considers that the option to use adhesive labels should be permitted on a definitive basis 
and that the deadline should no longer be allowed to be extended for further periods of time. 
Furthermore, Colombia reiterates that the policy under  which this standard is adopted, while, 
 
60 For previous statements follow the thread under ID 618 . G/TBT/M/86  
 
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  understandably, seeking to promote and protect public health, should be implemented in a manner 
that is no more restrictive than necessary and that does not subsequently create an unnecessary 
obstacle to trade.  Colom bia also considers 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 the packaging of products, will continue to be clear, legible,  prominent and 
comprehensible, as required by the regulations.  
2.176.   This technical measure on labelling that is so specific to a particular country, which must be 
implemented in the product's country of origin and does not allow the use of adhesive labels with 
the required information, is a technical barrier to trade; it constitutes a major access barrier, 
particularly for small and medium -sized enterprises.  Moreover, as far as Colombia is aware, there is 
no knowledge of there having been, during the period of a pplication of the standard permitting the 
use of adhesive labels, any situations that led to non -compliance with consumer information 
standards.  We welcome the bilateral talks that have taken place at different levels, and the progress 
reported. We ask Per u to take these considerations into account and, in its regulatory review, allow 
the use of adhesive labels on a permanent basis . 
2.177.   The representative of Brazil  provided the following statement. Brazil regrets having to once 
again express its concerns regard ing labelling requirements expressed in the Manual of Advertising 
Warnings approved by Supreme Decree 012 -2018-SA (notified under G/TBT/N/PER/97/Add.1)  and 
amended by Supreme Decree 015 -2019-SA (unnotified). The use of stickers is a widespread practice 
internationally, as it does not affect the provision of reliable information to consumers. Codex 
standard CODEX -STAN 1 -1985 for pre -packaged goods, Articles 8.1.1 and 8.2.1, explicitly allows for 
the possibility of using additional labels or stickers, as long as they are a ttached to the packaging 
and if the language of the original label is not necessarily that of the consumer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that help better inform consumers. Despite Peruvian legitimate concerns with deceptive 
practices, advances in labelling technologies allow for their safe affixation. We acknowledge that, 
according to Supreme Decree 018 -2021-SA, the entry into force of the prohibition on stickers was 
delayed until 31 March 2022. However, Brazil would like to respectfully ask Peru to permanently 
align its labelling requirements with current international standards established under the Codex and 
withdraw the prohibition of stickers for the products under the scope of the Manual of Advertising 
Warnings. Brazil considers such postponement a provisional solution and will continue to raise this 
STC until Peru permanently removes its burdensome requirements for food labelling. If a permanent 
solution is n ot feasible before the end of the month, Brazil would like to request to Peru, at least, 
another postponement of the entry into force of the measure.  
2.178.   The representative of the European Union  provided the following statement. The European 
Union (EU) appreci ates that Peru further extended the possibility for imported products to use 
stickers for compliance with labelling requirements for processed foods, until 31 March 2022. 
However, the EU would like to repeat once again the urgent invitation to Peru to prov ide for a 
permanent possibility for imported products to use stickers. As the deadline of 31 March approaches, 
trade is already being severely disrupted because retailers in the Peruvian market have stopped 
buying products with stickers. Such disruption is  akin to what happened in the months leading to 
the last year's deadline of 30 June and it represents 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 disp roportionate 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 aga in Peru to bilaterally work with the EU on this issue.  
2.179.   The representative 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 unde r Supreme Decree No.  015-2019-SA, which amends the Manual of Advertising 
Warnings approved by Supreme Decree No.  012-2018-SA of Peru.  The Permanent Mission of Peru 
in Geneva informed our delegation in a timely manner that the entry into force of this stand ard was 
being postponed until 31  March this year.  Although this postponement has offered some respite for 
our exporters, we wish nonetheless to reiterate our concern and respectfully request that the 
Peruvian authorities consider permitting the use of adhe sive labels on a reciprocal basis, given that 
these labels may be used on Peruvian food products to be marketed in Central America.  The food G/TBT/M/86  
 
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  industry has informed us of the negative repercussions on trade that a potential discontinuation of 
the use of adhe sive labels would have. It should be noted that the use of adhesive labels is widely 
recognized internationally, as such labels achieve the same public health protection and consumer 
information purposes achieved by permanent labels.  At the CODEX level, fo r 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 guaranteed that they will not become 
separated from the container, or i n cases where the language on the original label is not acceptable 
to the consumer for whom it is intended.  
2.180.   Furthermore, we note that countries with labelling schemes requiring the use of high fat, 
sodium or sugar content warnings, similar to Peru's, have considered supplementary labelling using 
stickers, which not only provides the required level of protection, but also makes it easier for 
exporters to comply with non -harmonized international requirements.  At the national level, Peruvian 
food products sent  to the Costa Rican market are able to comply with domestic labelling 
requirements through the use of supplementary adhesive labels, instead of having to affix 
permanent labels in the country of origin, exclusively for the Costa Rican market. This undoubte dly 
fosters trade and is proportionate to the level of protection sought. We therefore ask for reciprocity 
of treatment.  Moreover, we note that other Peruvian instruments, such as Supreme Decree 
No. 007-98-SA adopting the regulations on sanitary surveillan ce and control of food and beverages, 
permit the use of stickers to meet labelling requirements, given that this is an appropriate means 
for the fulfilment of the proposed legitimate objectives. The fact that Peruvian legislation, in other 
instruments, per mits the use of an adhesive or additional label no doubt shows that there are less 
trade-restrictive measures through which it is possible to fulfil the proposed legitimate objectives, 
in accordance with the obligations regarding technical barriers to trad e established in the relevant 
World Trade Organization Agreement and in the existing Agreement between our countries.  Costa 
Rica would like to emphasize once again, as it has already done before this Committee, that in light 
of the current global situation  and the post -COVID -19 economic recovery, international cooperation 
in all areas is crucial for tackling the crisis and laying the groundwork for a swift economic recovery 
post-pandemic, through the promotion of trade -facilitating measures, as opposed to m easures that 
might create technical barriers to trade and hinder economic recovery. In view of the above, we 
respectfully reiterate Costa Rica's wish that the Peruvian authorities to remove the proposal to 
prohibit the use of stickers and maintain the poss ibility of permitting their permanent use.  
2.181.   The representative of Chile provided the following statement. The delegation of Chile would 
like to note that the regulations established in Supreme Decree No.  015-2019-SA, which amends 
the Manual of Advertising W arnings approved by Peru, has caused concern among companies and 
guilds exporting foods to that country, as the acceptance of sticker -based labelling is temporary. 
Chile would be grateful if Peru would reconsider the established timeframe, which expires at  the end 
of this month.  
2.182.   The representative 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.  However, we are concerned that the extension of the use of adhesive labels expires on 
31 March 2022, which leaves importers without any legal certainty.  As stated in previous meetings, 
relevant international standards, where they exist, shall be used to avoid unnecessary obstacles to 
international trade . The CODEX CXS 1 -1985 General Standard for the Labelling of Prepackaged Foods 
states that a supplementary label may be used on imported products that do not comply with 
Peruvian regulations, which should accurately reflect the information on the original label.  We once 
again call on Peru to reconsider regarding the permanent use of supplementary adhesive labels, as 
a number of trading partners have already done and as has been previously discussed in this 
Committee.  The use of this adhesive label is widely  recognized internationally, as it achieves the 
same public health protection and consumer information purposes that Peru is seeking to achieve.  
2.183.   In response, the representative 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 connecti on, 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.  In response to the 
concerns expressed by some Members, Peru, by mean s of Supreme  Decree  No. 018-2021-SA, 
extended again, until 31  March  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 G/TBT/M/86  
 
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  approving the MAP under Law No.  30021 on the promotion of healthy eating among children and 
adolescents. In that regard, significant time has been granted for adaptation to the requirements 
established by the Peruvian regulations since their issuance.  Lastly, we reiterate that Peru wish es 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.  
2.1.3.18   European Uni on - Non-renewal of the approval of the active substance 
mancozeb, G/TBT/N/EU/712  (ID 62761) 
2.184.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regarding the measure notified by the European Union (EU) in document G/TBT/N/EU/712  
of April  2020 relating to non -renewal of the approval of the active substance mancozeb. As we have 
already explained, the EU has ado pted measures resulting in 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 detection level 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. On this occasion, we would like to ask the EU once again about the relationship 
between the notification in document G/TBT/N/EU/712  on mancozeb and the notification in 
document G/TBT/N/EU/797  regarding the REACH regulation, with respect to substances that are 
carcinogenic, mutagenic and toxic for reproduction. We would also like to recall that, even tho ugh 
in this and various other cases we have requested that the EU provide information on the time 
frames for the adoption of the standard and on the implementation of maximum residue levels, the 
EU has failed to respond to these requests. We ask it to plea se respond to these concerns.  
2.185.   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 expor ting Members, and particularly in developing country 
Members, to adapt their products or methods of production. In line with the above, the information 
available indicates that EFSA has initiated the procedure for revising MRLs for mancozeb. In this 
regard , we ask the European Union how, as interested trading partners, we can participate in this 
process, how our comments will be taken into account and what time frames are envisaged for a 
decision by EFSA. Lastly, we once again invite the EU to follow the re commendations 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.  
2.186.   The representative 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.  Paraguay shares t he objectives that the EU 
seeks to address with these policies, but does not share its adopted method for attaining them 
because it is not based on conclusive scientific evidence and does not consider less trade -restrictive 
options or valid alternatives fo r hazard control that, based on the requirements for emergency 
authorizations and the number of such authorizations approved for mancozeb, we can assume the 
EU agrees do not exist in this case, including in relation to the EU's climate conditions.  This is 
exacerbated in countries like Paraguay that have climatic conditions and pest -pressure levels that 
are very different from those in the European Union and that can be safely and effectively controlled 
by substances such as mancozeb.  We echo Colombia's ques tions 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 mancozeb and on how comments submitted by Members will be taken 
into account.  
2.187.   The representative 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 concer ns about 
the proposed non -renewal of Mancozeb and the potential impact on Maximum Residues Limits 
 
61 For previous statements follow the thread under ID 627 . G/TBT/M/86  
 
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  (MRLs) and effects this may have on trade, including wine exports to the EU. Australia seeks 
clarification on whether stocks which are in -market prior to the required period from entry into force 
of this regulation will continue to be eligible for sale in the EU. This was raised in the previous 
Committee meeting but Australia is not aware of the EU's position. Australia also notes that the EU 
has recently made several plant protection product non -renewal decisions and subsequent changes 
to relevant MRLs which are impacting Australia's trade with Europe. Australia seeks further 
clarification on how this decision will impact future decisions around MRLs. Australia  also notes that 
our competent domestic authority and Codex have determined MRLs for dithiocarbamates that 
ensure the continued protection of human, animal and environmental health while allowing trade to 
continue.  
2.188.   The representative 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 use is 
approved for many different crops by the B razilian 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 significantly impact the income of Brazilian farmer s. 
The availability of an alternative to mancozeb in the short to medium term is also limited by the fact 
that other substances of similar use have already been banned in the European market, such as 
chlorothalonil. Mancozeb is an important substance for t he 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 life cycle of other molecules. In light 
of the in sufficient transitional period granted by the EU, such crops cannot have their treatments 
changed in time for exportation to the EU market before the entry into force of the regulation. Brazil 
would like to urge European authorities to consider establishin g 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 and to consider less trade -restrictive 
alternatives t hat would also safeguard its legitimate policy objective and to grant treatment to 
Brazilian farmers no less favourable than that granted to European farmers.  
2.189.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express i ts 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 statements of t he delegations that have already 
taken the floor.  Costa Rica recognizes that Members have the right to determine the appropriate 
level of sanitary or phytosanitary protection needed to protect human, animal or plant life or health, 
and to establish measure s to that end. In turn, may we remind Members that these measures must 
be science -based and should not create unnecessary barriers to trade, especially at a time when the 
pandemic continues to affect the economic recovery of international markets.  To asses s just how 
crucial the substance mancozeb is to agricultural production in Costa Rica, it is sufficient to note that 
it is currently used for more than 20 crops that are grown for export and domestic consumption, and 
is therefore vital to ensuring the supp ly of food. Mancozeb is also used to combat pests of economic 
importance, particularly in banana production.  
2.190.   Costa Rica is the world's second largest exporter of bananas, and the first country to have 
obtained a geographical indication for this product. Th e main destination for exports is the European 
Union, to which over 50% of the fruit produced in Costa Rica is sent. In Costa Rica, there are 
currently no authorized plant protection products that could be used as substitutes for, or are similar 
to, mancoz eb. This illustrates the impact that would be generated by the ban on the use of mancozeb 
and the subsequent reduction in maximum residue levels (MRLs) for this substance in bananas.  
Despite Costa Rica's many reservations about the reasoning behind EU regu lations, the Costa  Rican 
banana sector continues to seek alternatives to mancozeb. However, time will be needed to complete 
the relevant tests and approval procedures for any alternatives found. Costa Rica therefore once 
again requests that the EU postpone  the non -renewal process and subsequent reduction of MRLs for 
mancozeb, so as to give the national sanitary and phytosanitary authorities a reasonable period of 
time to respond to the numerous challenges posed by the COVID -19 pandemic and subsequent 
econom ic recovery, and find an alternative substance so that Costa Rican farmers can continue to 
grow bananas and export the volumes required to meet the EU market demand.  
2.191.   The representative of Chile provided the following statement. The delegation of Chile 
welcomes the earlier statements concerning the EU's non -renewal of the approval of the active G/TBT/M/86  
 
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  substance mancozeb and echoes the trade concern raised at this meeting and previous meetings of 
the Committee.  
2.192.   The representative of Guatemala  provided the following statement. Guatemala maintains its 
position regarding this concern on measures to suspend or not to market active substances and to 
reduce MRLs as part of the process, in relation to which there is no information on scientific evidence 
of the damage to hum an health that might be caused by consuming fruits and vegetables, 
particularly those produced in Latin America.  Mancozeb is key for the production of a number of 
strategic agricultural crops that are exported to the European Union, such as fruit and veget ables, 
which would also affect tropical countries.  In terms of other types of agrochemicals, there are very 
few alternatives with multi -site properties available on the market for the control of fungi. This 
means that mancozeb, as a multi -site fungicide, a ttacks different parts of the fungus and creates no 
resistance. In the case of plantains and bananas, mancozeb is essential given the absence of 
alternatives providing the same effectiveness. Black Sigatoka is caused by the fungus 
Mycosphaerella fijiensis , which invades and necrotizes the leaf tissue, causing leaf death in perennial 
banana and plantain crops. Black Sigatoka is the disease that has the greatest economic impact on 
banana and plantain crops worldwide and is only successfully controlled with ma ncozeb.  The ban on 
the use of mancozeb will have a negative social and economic impact on the country, given that a 
number of  crops are a significant source of employment and foreign exchange generation, and of 
food for the families that depend on such crops.  
2.193.   The representative of Ecuador  provided the following statement. Ecuador reiterates its 
concern regarding the non -renewal of the substance mancozeb.  Mancozeb is a fungicide used 
throughout the world for a wide range of strategic crops, a number of which are produced in Ecuador. 
Examples include bananas, cocoa, broccoli, pineapples, pitahayas, mangoes and cape gooseberries . 
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 ag ricultural use with the active 
ingredient mancozeb are vital for agricultural production. Prohibiting the use of mancozeb - without 
effective alternatives - could have a very significant economic impact on small -, medium -, and 
large-scale producers in Ecua dor, as well as on consumers in the European Union (EU), because the 
supply of our products would be affected.  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. Black Sigatoka is 
considered to be the most destructive foliar disease for banana and plantain crops; it is thought to 
pose the highest economic risk for such crops and can cause yield  losses of up to 50%. It is 
concerning that there are currently no approved and properly registered alternatives to this 
substance that are as effective as mancozeb.  
2.194.   Ecuador urges the EU to take into consideration the relevant scientific information emanat ing 
from international specialized agencies recognized by the WTO, such as the Codex Alimentarius, 
which has information relating to this substance.  We wish to recall that Ecuador was part of a group 
of 39 WTO Members that, in 2020, called upon the EU to t emporarily suspend processes related to 
the review of authorizations for the marketing and use of plant protection substances, and their 
entry into force, in the context of COVID -19. For these reasons, Ecuador calls upon the EU to consider 
alternative meas ures that are less trade -restrictive, to identify substitute substances that enable 
existing trade to continue, to base its measures on conclusive studies, not only the 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.  
2.195.   The representative of Uruguay  provided the following statement. Mancozeb is an active 
substance that is authorized and widely used in a safe ma nner 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 fruits. It is particularly important for the control of apple and pear scab, 
which i s the main disease affecting apple and pear production and is caused by fungus of the genus 
Venturia  spp. In this connection, we support the concerns and requests raised by other delegations, 
particularly with respect to the possibility that, as a result o f the ongoing review process, the 
European Union may significantly reduce the corresponding MRLs, even lowering them to the limit 
of determination, without having any conclusive scientific evidence that substantiates such a decision 
in line with the WTO SP S Agreement.  Against this backdrop, like other Members, Uruguay recalls 
the importance of taking due account of international standards, guidelines and recommendations G/TBT/M/86  
 
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  and the scientific information produced by international standard -setting bodies recogni zed at the 
WTO, such as the Codex Alimentarius.  
2.196.   The representative of Panama  provided the following statement. The delegation of Panama 
reiterates its concern regarding the non -renewal of the active substance mancozeb. Mancozeb is 
vitally important for the country's main crops, especially bananas.  At present, there is no other 
active ingredient that can replace mancozeb, leaving the industry without any phytosanitary tools 
and consequently having a severe impact on Panama's exports to the E uropean Union. Panama 
recognizes the right of Members to determine the appropriate level of sanitary or phytosanitary 
protection necessary to protect human, animal and plant life or health, but such measures must be 
science -based and should not create unne cessary barriers to trade.  In view of the above, Panama 
reiterates its request to the EU to follow the recommendations of good practice and we join other 
Members' enquiry as to how the European Union will take account of the comments submitted by 
Members.  
2.197.   In response, the representative 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 Committee a draft Commission I mplementing Regulation 
concerning the non -renewal of the approval of the active substance Mancozeb, in accordance with 
Regulation (EC) No 1107/2009 on the placing of plant protection products on the market. 
Implementing Regulation (EU) No 2087/2020 entered  into force on 4 January 2021. The non -renewal 
was based on a scientific assessment conducted under Regulation (EC) No 1107/2009 by experts 
from the EU member States and the European Food Safety Authority (EFSA). Since EFSA concluded 
that Mancozeb does not  meet the approval 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 authorizations for plant protection products containing Mancozeb at the latest b y six months 
from the date of entry into force of the Implementing Regulation (by 4 July 2021). Possible grace 
periods granted by EU member States, in line with Article 46 of Regulation 1107/2009, expired, at 
the latest on 4 January 2022 after 12 months fr om its entry into force. The EU would like to inform 
Members that EFSA has started a review of the existing Maximum Residue Levels (MRLs) for 
dithiocarbamates (group of which Mancozeb is part). We informed Members at the last TBT 
Committee meeting that int erested parties had been invited to actively contribute with relevant 
information to this MRL review through the main authorization holder, as described in document 
G/SPS/GEN/1494/Rev.1 .62 The EFSA scientific opinion on dithiocarbamates is expected to be 
published in the first half of 2022. For advice on alternatives to Mancozeb, the EU pesticides 
database63 is publicly available and contains information on all active substances, their approval 
status and their main purpose (e.g. fungicide, insecticide or herbicide). As re gards the joint Request 
for the suspension of the processes and entry into force of reduction of Maximum Residue Levels 
(MRLs) of plant protection products in light of the COVID -19 pandemic in documents 
G/SPS/GEN/1778  and G/TBT/GEN/296  and subsequent revisions, the EU position is included in the 
document of 28 Ma y 2021 with double reference G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315  
circulated in both Committees.  
2.1.3.19   India – Draft Food Safety and Standards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 66764) 
2.198.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Draft Food Safety and Standards (Import) Amendment Regulation, notified to the 
Members of this Committee by the Government of India on 25  November  2020 in document 
G/TBT/N/IND/180 . Considering that this issue was repeatedly raised in this Comm ittee in its three 
meetings in 2021, we appeal to the good offices of the delegation of India to respond to this enquiry 
as soon as possible.  In response to the statement we made in this Committee in November  2021, 
the delegation of India explained that th e comments received from interested third parties continued 
to be analysed. We would therefore be grateful for them to share with us any updated information 
in that regard. As we have mentioned, this measure is of great importance to Mexico's industry and 
Government and we are therefore very interested 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.  
 
62 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl -review_en.pdf . 
63 https://ec.europa.EU/food/plant/pesticides/eu -pesticides -db_en . 
64 For previous statements follow the thread under ID 667 . G/TBT/M/86  
 
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  2.199.   The representative 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 will become applicable as of June 
2022. However, 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 measure appears much more trade restrictive than necessary to fulfil the intended 
food safety objectives. The European Union would like reiterat e 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 obligation shall apply to 
food (and drink) pr oducts presenting a specific risk, no list of such products exists in the rules 
themselves. With less than six months left before the entry into application, it is now urgent that 
India clarifies the intended scope of these new rules. 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 pr esent sanitary risks such as spirits or wine, will be excluded from the 
scope of these new obligations. The measure provides for registration and inspection of foreign food 
(and drink) manufacturing facilities. However, further clarity is needed with regar d 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.  
2.200.   The representative of the United States  provided the following statement. The United States 
remains concerned with India's draft measure, notified to the WTO TBT Committee as 
G/TBT/N/IND/180 . This draft regulation leaves many unanswered questions for foreign food 
manufacturing facilities, competent authoritie s, and other stakeholders. The United States has raised 
this issue at previous TBT Committee meetings, and India responded that it was reviewing comments 
received. The United States wishes to reiterate our main concerns, and we ask that India please 
provid e a more detailed response and update on the status of the proposed regulation. The draft 
regulation states that India may identify categories of "risk" for food products "from time to time… 
for which inspection or audit of foreign food manufacturing facil ities producing such categories of 
foods shall be mandatory. " We are concerned about the lack of detail regarding the scope of this 
proposed 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.  
2.201.   The representative of Japan  provided the following statement. Japan shares the concerns 
with other Members on India 's proposed draft amendment regulation on food safety and standards.  
The regulation would impose additional burdens on business operators who plan to export 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 o n the regulation in details such as scope of food 
and facilities registration procedure.  Moreover, Japan emphasizes the importance to provide a 
sufficient transition period before the implementation of the new rules. Japan considers the transition 
period o f 180 days from publication in the Official Gazette is still not sufficient. Japan suggests that 
the transition period be extended to more than 18 months.  Japan requests India to sincerely address 
Members ' concerns and comments and to ensure the proposed n ew rule does not create unnecessary 
trade barriers.  
2.202.   The representative of Australia  provided the following statement. Australia recognizes the 
right of the Indian Government to take measures necessary to protect public health. Australia thanks 
India for th eir engagement on this issue during a technical discussion between the Food Safety and 
Standards Authority of India (FSSAI) and the Department of Agriculture, Water and Environment in 
late 2021. FSSAI advised at that time that the proposed regulations will  not apply to all food 
establishments. Australia would welcome written confirmation of this advice from FSSAI. Australia 
also recommends that the regulation should be amended to clarify the categories of food included. 
The proposed measures should be linke d to the risks posed by the imported food. Australia is happy 
to work with India to support a more risk -based approach to food safety.  
2.203.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at the TBT Committee meetings in February, June and November 2021 G/TBT/M/86  
 
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  regarding India's draft amendment to its Food Safety Standards (Import) Amendment Regulation 
pertaining to the registration, inspection and/or audit of foreign food manufacturing facilities 
producing f ood 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 the level of risk for food products imported into India, what circumstances would instigate 
an audit or an inspection of a foreign manufacturing facility or, how such actions will be taken given 
the ongoing travel restri ctions resulting from the pandemic. In addition, Canada remains concerned 
with the measure's on 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 trade. 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 inform when it 
expects to provide the requested details. In closin g, Canada recalls its request 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.  
2.204.   In response, the representative of India provided the fol lowing statement. The FSS (Imports) 
First Amendment Regulations, 2021, provides the legal framework for the registration and inspection 
of Foreign Food manufacturing facilities intended for export to India. As prescribed, the registration 
and inspection of  such facilities may be based on the risk associated with the food category as 
specified by the Food Authority from time to time. The detailed guidelines in this regard may be 
separately published, including SOP, procedural information, and guidance for th e foreign food 
manufacturers to comply with the said regulations. It may be noted sufficient time for 
implementation shall be provided for compliance.  
2.1.3.20   Egypt – Halal Certification Measure, based on Egyptian Standard ES 4249/2014 
General Requirements for Hal al Food According to Islamic Sharia, G/TBT/N/EGY/313 , 
G/TBT/N/EGY/313/ Add.1  (ID 71865) 
2.205.   The representative of Canada  provided the following statement. Canada joins the United 
States, the European Union and other intervening Members to raise its continued concerns with 
Egypt's new halal certification requirements for all impor ted food and beverage products which came 
into effect as of 1 October 2021. While 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 Sha ria, 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 De cember 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 and have those comme nts taken into consideration prior to that measure being 
finalized. A reasonable amount of time, understood as a period of not less than six (6) months, 
should be provided between the publication of a regulation and its entry into force to allow time for 
industry and Members to review and implement the new requirements. This was obviously not the 
case with this measure.  
2.206.   Canada is also concerned with the lack of details, documentation and specificity on how 
these requirements will be implemented and how spec ific products will be impacted. For example, 
the proposed new regime only specifies one Egyptian certification body that will have the authority 
to certify halal products for the Egyptian market, and to our understanding, this has already 
significantly rai sed 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 state d 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 respectf ully request that Egypt suspend the implementation of the 
measure.  
2.207.   The representative of the European Union  provided the following statement. The European 
Union would like to express its 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 
 
65 For previous statements follo w the thread under ID 718 . G/TBT/M/86  
 
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  the negative impact this measure would have on food and beverages imports to Egypt. The EU 
regrets that Egypt notified to the TBT Committee the requirements fo r the importation of meat, 
poultry and their products, milk and dairy products only on 1 December 2021, after their entry into 
force in October, 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 days) for other Members for 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.  
2.208.   The EU would like to thank Egypt for useful bilateral contacts. We welcome some of the steps 
envisaged to mitigate the negative impact of the measures, such as the grace period until 15 
December 2 021 during which, certification by "IS EG Halal " was voluntary and for free. We also 
appreciate 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. Nevertheless, some of those facilitations were only temporary and the 
companies will not have sufficient time to adapt to the new certification and labelling requirements. 
This is why the EU would urge Egypt  to postpone the implementation of this measure and to provide 
for a reasonable adaptation period of at least one year, 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 practices. 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 coronavirus 
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 TBT notification form. The EU would like to ask Egypt to con sider 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 halal -certified food or not,  based on clear labelling.  
2.209.   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 certification 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 product s 
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 ask about the status of the revision and t he timeline of 
the TBT notification. 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, including detaile d description of the certification procedure, its duration, 
costs, and required documents, as well as process for registration of suppliers, and the product 
coverage (with HS codes). The EU would also like to know whether Halal certificates will be require d 
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 imports to Egypt.  
2.210.   The rep resentative 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. We appreciate Egypt's notification of G/TBT/N/EGY/313  to the WTO TBT 
Committee on 1 December 2021, and an Addendum on 7 January 2022. The United States submitted 
comments to Egypt's TBT Enquiry Point on 28 January 2022 and 24 February 2022. We look forward 
to receiving a response. Our goal is to ensure that US exporters can co mply with all Egyptian import 
regulations. In order for our exporters to effectively comply, it is paramount that Egypt is transparent 
about its requirements. This is particularly important given the current need for predictive trade 
flows in a challenging  pandemic -caused environment. We understand that Egypt is revising the 
requirements contained in G/TBT/N/EGY/313  for mandatory halal certification, including changing 
the scope of products that would be covered under the future measure. Could Egypt please clarify 
whether our unders tanding is correct and please provide a timeframe as to when we can expect 
notification to the TBT Committee? Will Egypt provide a comprehensive list of HS lines covered by 
the future measure? The United States has concerns about the lack of transparency r egarding G/TBT/M/86  
 
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  Egypt's implementation of current halal certification requirements. The United States invites Egypt 
to provide information on fee schedules, audit procedures, labelling requirements, export 
registration requirements, etc.  
2.211.   In G/TBT/N/EGY/313 , Egypt noted that it would need to approve certification bodies. 
However, it is unclear how Egypt currently approves certifiers and whether that process is changing. 
For many years, certification bodies around the world have successfully certified halal product for 
export to Egypt. It ha s been nearly three years since Egypt delisted a number of US halal certification 
bodies that had previously been approved to certify meat and poultry exports to Egypt. Could Egypt 
please state the reasons for delisting these certifiers and explain how the se certifiers can be relisted? 
The United States invites Egypt to publish and notify to the WTO information about the process and 
standards used to approve or delist certification bodies, as well as any proposed changes. The United 
States notes that having  a diversity of certification bodies available to conduct halal certification is 
important to ensure that halal services remain open and competitive. When Egypt limited halal 
certifiers for US beef and poultry products to a single certifier in 2019, certif ication fees increased 
by 1,000%, resulting in higher prices to Egyptian consumers. The United States requests Egypt to 
share information about how it is ensuring that certification fees are commensurate with the services 
provided. The United States thanks  Egypt for sharing a document entitled Annex I: Global 
Documents needed for Halal Certification of the Establishments. However, the document does not 
indicate whether it is a mandatory official Egyptian regulation or a voluntary guideline. We are 
concerned  that this document conflates food safety and halal (e.g., "safety data sheet, " "analysis 
for heavy metals and pesticide residue, " etc.).  
2.212.   We request that Egypt identify the source of Annex I and notify it to the WTO TBT Committee. 
We ask that Egypt please separate these food safety requirements from its halal -related 
requirements. The United States strongly urges Egypt to immediately delay and suspend 
implementation of any new halal certification requirements until all concerns have been addressed, 
includin g those relating to changes regarding halal certification bodies. We also request an 
implementation period of at least six months before enforcement to give exporters and halal 
certifiers a reasonable time to modify operations to meet any new halal certifi cation requirements. 
In closing, the United States recognizes Egypt's right to require appropriate halal certification, but 
we expect Egypt to fully meet its WTO obligations when implementing new requirements that have 
the potential to disrupt trade.  
2.213.   The representative of Australia  provided the following statement. 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 December 2021, via G/TBT/N/EGY/313 . Australia 
appreciates advice that imports of meat, poultry, milk and dairy products must be accompanied by 
a Halal certificate issued by an exporting country certification body as determine d by Egypt's General 
Organisation for Veterinary Services. We also appreciate provision of the revised draft standard, ES 
4249/2014 – General requirements for Halal food products in accordance with the provision of 
Islamic Sharia – particularly the additio nal annex - Global documents needed for Halal certification 
of the Establishment – which is being considered for inclusion. We further welcome the advice 
received bilaterally that Egypt intends to notify further changes to product scope for IS EG Halal 
certification requirements, and that implementation will only occur after Members have been 
provided an opportunity to comment and for those comments to be considered. In addition to this, 
Australia requests that a further notification clarifying the determin ation of Halal certification bodies 
by Egypt's General Organisation for Veterinary Services and rationale behind requested documents 
under the proposed additional annex to ES 4249/2014 be provided. Australia is also grateful for 
Egypt's notification of any  proposed changes to any intended changes to those standards 
complementary to ES 4249/2014. Australia welcomes ongoing discussion on the implementation of 
Egypt's new Halal certification measures to ensure they meet Egypt's policy goals while also ensuring  
measures are not more trade restrictive than necessary.  
2.214.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
the opportunity to speak in support of the concerns raised by the European Union, Canada, and the 
United State s. We thank Egypt for its bilateral engagement to date on this matter. As outlined at 
the last TBT Committee, New Zealand understands that Egypt is implementing 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. Certification from other Halal assurance bodies will not be accepted 
for goods imported into Egypt. New Zealand also understands that the measures may apply to a G/TBT/M/86  
 
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  broad category of food and drink pr oducts imported into Egypt, irrespective of whether Halal labelling 
is applied to those goods, and irrespective of whether these goods have previously been treated as 
Halal. For example, fresh fruit, vegetables, milk and other dairy products that do not in clude any 
other ingredients or additives. New Zealand still has serious concerns with these measures. New 
Zealand would like to draw Egypt's attention to its WTO obligations, including its obligations under 
the TBT Agreement concerning the use of conformit y assessments, including under Articles 5 and 6, 
and the requirement that measures not be more trade restrictive than necessary. New Zealand 
would like to better understand what consideration Egypt has accorded to less trade -restrictive 
alternatives.  
2.215.   We ar e also interested in what factors led Egypt to introduce a measure that only allows 
conformity with the relevant Halal standard(s) to be determined by a single commercial body, and 
requires Halal certification of products, which have commonly been treated as Halal. We also share 
concerns as mentioned by the US, that if SPS measures are being imposed on manufacturers with 
additional sanitary information being required for registration with IS EG Halal, these should remain 
out of scope for Halal certification  and be addressed by sanitary certification and management by 
the relevant Competent Authorities for SPS matters. New Zealand would like to thank Egypt for the 
WTO notification G/TBT/N/EGY/313  dated 1 December 2021, though we would like to note that a 
final updated Egypt Halal Stan dard 4929 -2014 is yet to be provided and notified to the TBT 
Committee in accordance with Article 5.6.2 of the TBT Agreement. New Zealand would also like to 
thank Egypt for the extension for dairy certification requirements until 28 February 2022. We reque st 
that the new measures be suspended until all WTO obligations, including dairy Halal certification, 
including those requiring consultation with other WTO Members, have been met.  
2.216.   The representative of Paraguay  provided the following statement. Paraguay shares Egypt's 
concern that consumers be provided with certainty regarding the purchase and consumption of Halal 
certified products; however, as a food exporter to Egypt, we continue to follow closely the 
impleme ntation of this measure and the information that Egypt can give us about it.  In particular, 
we still do not have specific information about the products that would be covered by this measure, 
certification procedures, costs or labelling requirements, as we ll as other information needed to 
assess the adaptation of operators.  With respect to the certification and labelling obligation, even 
for those products that do not claim to be Halal, we request that Egypt confirm this requirement and 
consider keeping cer tification on a voluntary basis in order to meet the legitimate requirement to 
provide accurate information to consumers without it becoming a trade restriction.  Paraguay 
requests that Egypt delay the implementation of the new Halal certification requireme nts until 
Members have all of the information requested and trade operators have had enough time to adapt 
in order to ensure their compliance.  
2.217.   The representative of Switzerland  provided the following statement. Switzerland is following 
this matter with int erest 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. Whil e 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. The measures 
appear to be more trade restrictive th an is necessary to ensure legitimate 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 are conc erned 
that extending halal certificates to products other than livestock and poultry products could create 
additional costs for businesses and increase prices for consumers, which would have a negative 
impact on bilateral trade. Switzerland invites Egypt t o comply with the notification obligations under 
the TBT Agreement and provide detailed information about the new measure, including detailed 
description of the certification procedure, its duration and cost, as well as the product coverage.  
2.218.   The representa tive of Argentina  expressed its concern and deep regret with regard to the 
current situation in Ukraine. As Foreign Minister Cafiero said in his statement in the High -level 
Segment of the Human Rights Council, Argentina reiterate d the request to the Russian Federation 
to cease immediately the use of force, and it condemn ed the invasion of Ukraine and the military 
operations on its territory.  
2.219.   Argentina provided the following statement. Argentina reiterates its concern about this 
measure along the lines expressed at the previous meeting of this Committee.  Argentina thanks 
Egypt for the notification submitted on the amendment to the new Halal regulations. In relation to G/TBT/M/86  
 
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  this notification, Argentina would like to: emphasize that doubts remain about the scope of the 
regulation, the products included and the implementation mechanisms, taking into account that the 
documentation submitted is not completely clear or precise in its definitions ; ask Egypt to formally 
submit complete documentati on specifying the details included in the proposed regulation ; underline 
that we agree with other countries on the need for detailed information on timeframes, procedures 
and labelling, and call on Egypt to consider delaying the entry into force of this re gulation until there 
is sufficient clarity.  Lastly, we wish to state that Argentina sent comments through the WTO Focal 
Point, when the notification was submitted by Egypt on Halal last January, and hope that Egypt will 
take these into account in the corre sponding legislation.  
2.220.   The representative of Chile provided the following statement. Chile supports the STC recently 
mentioned by Canada, the United States and the European Union. Chile is concerned by the lack of 
alternatives for certifying products, such as agreements between ISEG Halal and certification entities 
in third countries, given that Chile is home to internationally recognized certification centres that 
could be recognized by Egypt, thereby avoiding the creation of unnecessary barriers to trade.  
2.221.   The representative  of Ukraine  thank ed Members for continuing to express their support to 
Ukraine in the course of this meeting . 
2.222.   Ukraine provided the following statement. We would like to thank Egypt for their submission 
of notification and information that  has been provided to our Enquiry Point so far. For the reasons 
outlined yesterday, I do not have any further specific details to provide today but would like to 
indicate our continued interest in this issue at hand.  
2.223.   In response, the representative of Egypt provided the following statement. Egypt thanks 
Canada, the European Union, the United States, Australia, New   Zealand, Paraguay, Switzerland, 
Argentina, Chile and Ukraine for raising this issue and their continued engagement on this matter 
recognizing Egy pt's right to determine appropriate halal certification requirements. Egypt notes the 
issues that have been raised in today's meeting and former meetings concerning Egypt's Halal 
certification requirements with respect to meat, poultry and their products a nd milk and dairy 
products (except for crude milk). Since the last TBT Committee meeting in November 2021, Egypt 
has made two notifications to the TBT Committee, G/TBT/N/EGY/313  and G/TBT/N/EGY/313  /Add.1, 
in which the product coverage and timelines for entry into force have been clarified. Any change in 
product coverage shall be duly notified. Furthermore, Egypt through its TBT Enquiry Point has replied 
to the questions received from our trading partners concerning the measure at hand, and is currently 
in the process of replying to the questions that have b een recently received and the follow -up 
questions received on 31 January 2022.  
2.224.   Taking into account the issues and concerns raised by Member countries, 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 Egypt until 28 February 2022. It is important to note 
that since the adoption of the measure no imports of milk and dairy products have been denied entry 
into Egypt. Hence, it is believed that b usinesses have been provided an appropriate period of time 
to adapt to the set requirements . Furthermore, Egypt is currently considering further facilitating 
measures based on the comments received from WTO Members and shall be duly notified once 
adopted.  As for meat, poultry and their products, Halal certification requirements have been in place 
since many years ago, and they are not a newly introduced measure.  Halal certificates issued by the 
certification bodies in the exporting country are accepted prov ided that the relevant Egyptian 
regulatory authority (the General organization for veterinary services (GOVS) in this case) approves 
and recognizes this body.  
2.225.   The relevant authority has recognized IS EG Halal companies in the different countries as 
the cer tification bodies to issue this certificate. Noting that those certification bodies are established 
and operating according to the relevant laws of the country in which they are established including 
in the United States of America, Uruguay, India, New Zea land, Germany. It is worth mentioning that 
previous companies issuing the Halal certificates have not abided by the requirements set by the 
relevant Egyptian Authorities. The certification process starts with registration at the recognized 
certification bo dy, whereby: (i) The supplier registers on the ISEG HALAL website, then fills out the 
application form and completes the required documents. A date is then set for an audit visit (whether 
physically or virtually) of the facility or factory to verify the ap plication of halal requirements ; (ii) 
Once the facility is approved, IS EG will provide a supervisor to continue overseeing the facility. This 
supervisor will provide ease of mind that all produce is Halal ; (iii) When products are approved by G/TBT/M/86  
 
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  an IS EG supervisor, the produce will be certified as Halal and the certificates will be issued ; (iv) The 
supplier then obtains an account registered in the electronic system of ISEG HALAL, and after 
checking and shipping the shipments, the supplier uploads the shipment documents to his electronic 
account. Worth mentioning, is that there are no authentication costs associated with the Halal 
certificate ; (v) There are no charges relating to approving the facility. However, the c ost of issuing 
the certificates per container is dependent on the type of the product and the quantity ; and (vi) The 
process takes an average time of seven working days.  Finally, I would like to express Egypt's 
readiness to continue its bilateral exchanges  on the subject matter with all interested trading 
partners.  
2.1.3.21   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 57666) 
2.226.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates China for its close cooperation through bilateral channels, and for providing a 
response to Korea's comments concerning the specifications and regulations under this STC. 
However, Korea c ontinues to be concerned as China's response did not provide an answer to Korea's 
enquiry but only gave a general explanation on the implementation of measures, and did not duly 
address Korea's concerns in the finalized specifications and regulations. Firs t, exporters to China are 
required to specify the sources and quality data of all ingredients in their applications, which is 
demanding more information than that of other countries. Korea would like to request China to 
provide an evidence -based explanatio n for its measures as such information may contain trade 
secrets that are critical to businesses, and China's requirements are more rigorous than necessary 
to fulfill the objectives of ensuring product safety and compliance with China's domestic market 
norms. Furthermore, according to Appendix 12 -14, businesses are required to disclose information 
on ingredient safety, which is concerning since businesses' intellectual property and commercially 
sensitive information may be unprotected. At the TBT Committee meeting in June 2021, China 
replied such information are not publicly available and legal provisions that protect confidential 
information will be added in cosmetic -related specifications and regulations. In relation to this, Korea 
would like to request Ch ina to provide explanation of the provisions in detail.  
2.227.   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). Du ring the last meeting, China replied a number of foreign laboratories within 
the country has obtained CMA. However, Korea requests China to offer flexibility by recognizing test 
reports from foreign laboratories located overseas or internationally recogniz ed laboratories that 
comply with international standards such as Good Clinical Practice or Good Laboratory Practice. 
Third, as per Article 13 of the New Cosmetic Ingredients Authorization and Registration Regulation, 
exporters are required to provide evide nce that proves their test results of alternative test methods 
are equivalent to the results of in vivo  toxicity testing method, or animal testing. Korea would like 
to request China to recognize alternative test methods approved by the OECD or other intern ational 
organizations without requiring the submission of equivalence evidence. Fourth, regarding the 
"Administrative Measures on Cosmetic Labelling, " Korea requests China to ensure that labelling 
requirements comply with internationally recognized practic es. In particular, Korea requests China 
to maintain its current regulation on the requirement of ingredient declaration in cosmetic labelling. 
In most countries, cosmetic ingredients are subject to declaration when the substances are at a 1% 
or higher conc entration. However, China's proposed regulation requires substances that are at a 
0.1% or higher concentration to be declared, and substances at a concentration lower than 0.1% to 
be declared as "other ingredients in small amounts. " With regard to this, Ko rea requests China to 
harmonize its regulations with international practices so as not to raise unnecessary barriers to 
trade. Fifth, under the Specifications for Cosmetic Efficacy Claim Evaluation, China requires 
summarized scientific evidence that suppor ts cosmetic efficacy claims to be disclosed on NMPA -
designated websites. Korea, however, requests China to pare down the information it requires, as 
the information may contain trade secrets or undisclosed information that are critical to businesses. 
In the last meeting, China responded trade secrets protection laws will be strictly complied with 
 
66 For previous statements follow the thread under ID 576 . G/TBT/M/86  
 
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  when managing the registration and filing of cosmetic products. Regarding this, Korea would like to 
request China to provide concrete explanation on the measures t aken for compliance.  
2.228.   The representative of Australia  provided the following statement. Australia respects the right 
of Members to implement technical measures for legitimate policy purposes and in accordance with 
obligations under the TBT Agreement. Austra lia remains concerned that measures under China's 
Cosmetics Supervision and Administration Regulation (CSAR) and its various implementing 
regulations, which entered into force on 1 May 2021, are more stringent than necessary to ensure 
the safety and qualit y of imported cosmetics. We thank China for its response to our comments in 
January this year on notification G/TBT/N/CHN/1626  on Good Manufacturing Practice (GMP). 
Australia however remains concerned that the implementation date for this regulation was given by 
China as effectiv e from 1 January 2022. Australia notes that this draft regulation was only notified 
to the WTO in September 2021, with comments due on the notification by 19 November 2021. 
Australia requests that China provide a transition period until at least January 20 23 for cosmetics 
manufacturers to consider the regulation's requirements and make adjustments to their processes.  
2.229.   Australia also thanks China for its response to notification G/TBT/N/CHN/1615  on the 
Provisions for the Supervision and Administration of Children Cosmetics. Australi a remains 
concerned that China 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. 
Australia is a reliable supplier of high quality and safe cosmetics products domestically, and to 
international markets. As we have said before, the Australian Government stands ready to work with 
China and discuss the CSAR, including subordinate regulations such as those for children's cosmetics. 
Australia would like to work with China to achieve clarity and certainty for businesses and to ensure 
trade in cosmetics can occur under transparent, science -based and non -discriminatory conditions. 
Australia welcomes the opportunity to exchange information and prom ote a better understanding of 
our respective regulatory systems for cosmetics.  
2.230.   The representative of the United States  provided the following statement. It is unfortunate 
that the significant trade concerns that the United States raised with respect to the  Cosmetics 
Supervision and Administration Regulation (CSAR) implementing measures remain. As published, 
these measures will pose significant risks to companies' intellectual property and are not 
proportionate to cosmetics' low risk compared to medical prod ucts; and we have serious concerns 
whether it accords unequal treatment to imports. First, we have significant concerns that the only 
means China provides importers to establish conformity with good manufacturing practices requires 
animal testing if their respective governments do not issue good manufacturing practice or 
manufacturing export certificates. We question China's rebuttal to the comments of several WTO 
Members that its requirements for imports and domestic products are equivalent. The United Sta tes 
reiterates its request that China consider the several less trade -disruptive means previously 
suggested for importers to demonstrate conformity to China's requirements. For instance, providing 
a means to establish conformity with ISO 22716, the ISO sta ndard for cosmetics good manufacturing 
practice, would be a far more effective means of establishing companies' compliance with the 
elements of good manufacturing practice than animal testing. Second, we understand that the Good 
Manufacturing Practices for  Cosmetics (GMP), a draft of which was notified as G/TBT/N/CHN/1626 , 
was recently published as final in China. We ask China to confirm that for the purposes of overseas 
inspections, foreign manufacturers will be considered in conformity with Chinese GMP if their GMP 
practices are  in conformity with international GMP standards.  
2.231.   Third, the United States remains concerned that CSAR and its implementing measures 
require overly extensive information to assess product and ingredient conformity to China's 
regulatory requirements. We are disappointed that China has not pared back these highly 
burdensome requirements. Fourth, we consider that China has failed to address concerns of the 
United States and 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. Fifth, we 
are disappointed that China continues to frequently require duplicati ve in-country testing to assess 
product claims without considering internationally validated methods or data and testing from 
international labs accredited to Good Laboratory Practices or Good Clinical Practices. Allowing foreign 
laboratories with faciliti es in China to conduct this testing does not address this burdensome practice. 
Sixth, the United States remains concerned with the new cosmetics labelling requirements and 
requests additional clarification. While we appreciated China's clarification that o nly the contents of 
foreign product safety and efficacy claims must correspond with the Chinese label, we would greatly G/TBT/M/86  
 
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  appreciate if China would confirm that it will not require foreign labelling to exactly match the 
Chinese label. Our industry would also  appreciate a means whereby US importers could 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. We request that China 
continu e to consider how these trade concerns expressed by the United States and many other WTO 
members may be resolved in the implementation of CSAR, so as to support its successful 
implementation.  
2.232.   The representative of Japan  provided the following statement. Wi th 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 ", which wa s promulgated on 10 September 2019, 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 in China 
that obtained CMA (China Inspection Body and Laboratory Mandatory Approval). Japan understands 
foreign capital testing laboratories in China can obtain CMA. However, testing laboratories in foreign 
countries are not within the scope of CMA. Japan would like to  request a more flexible framework in 
which test results obtained by foreign laboratories with the equivalent qualifications and abilities as 
those of Chinese testing laboratories are accepted. In addition, regarding test methods, the 
implementing regulati ons of the "Cosmetics Supervision and Administration Regulation " stipulates 
that test methods including test items other than those stated above, can be conducted in 
accordance with China's national standard or relevant regulations, and that various restri ctions and 
conditions are imposed in the case of conducting a test method which is not specified in the 
regulations. Japan understands the same restrictions and conditions are imposed regarding imported 
and domestic products. However, Japan would like to r equest that China accept internationally 
accepted methods such as alternative test methods established by the OECD, or the ISO so as not 
to be more restrictive than necessary in proving safety and efficacy.  
2.233.   2. The sales certification that proves the produc ts have been sold on the market in the 
country of production is only imposed on imported cosmetics. Japan requests that China treat 
imported products no less favourably than products produced in China. In addition, regarding 
"Administrative Measures on Cos metic Labelling ", which was promulgated on 3 June 2021, Japan 
would like to express its following three concerns. 3. Article 5 stipulates that the content of the 
added Chinese labels, such as information regarding product safety and efficacy, must be consi stent 
with the original labels. We are concerned that the fact that Chinese characters are also used in 
Japanese may cause problems. For example, under Japanese regulations, it is obligatory to attach 
a label to indicate that an ingredient has some effect but does not belong to the medicine category, 
but the Chinese character for "medicine" is used on the label. However, some things that do not 
belong to medicine contain a character which means medicine in the Chinese language, so it will be 
possibly regard ed as "pharmaceutical products " and not compliant with Chinese regulations. Under 
old regulations, it was permitted to explain, in the Chinese label, that the Chinese character "quasi -
drug" in the original Japanese label does not mean it is a pharmaceutica l product. Japan would like 
to ask for clarification that the same correspondence will be acceptable from now on. Due to the 
above, Japan would like to request that China assure that the labelling stipulated by the regulations 
of the country of origin does  not have to match the content on the Chinese label, including the 
content related to product safety and efficacy.  
2.234.   4. Regarding Article 6, 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 article to inform consumers of the persons responsible for product quality and efficacy. In order 
to avoid confusion among consumers, Japan would like to ask China that the label should indicate 
only a singl e responsible person ( "cosmetics registrants or filers " or in the case of imported products, 
"responsible person in China"), and Japan considers that the label requirements regarding producers 
are not necessary. 5. With respect to the rules for labelling o f 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. Many cosmetic ingredients can perform their desired function even 
at 0.1% or less. Japan would like to request that China assure that t he rules for labelling follow the 
internationally recognized practice so as not to be more trade restrictive than necessary. Moreover, 
the "Provisions for Cosmetics Registration" stipulate that overseas inspections are to be conducted 
in accordance with re levant regulations of overseas inspections.  G/TBT/M/86  
 
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  2.235.   Regarding "Interim Measures on the Administration of Overseas Inspections of Cosmetics ", 
Japan would like to continue to express concerns on the following three points. 6. 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 legitimat e objectives 
under the TBT Agreement are fulfilled. 7. The subject of the inspection including the product research 
and development stage is broader than necessary, and it causes unnecessary burdens for 
companies. The main purpose of the inspection seems t o ensure product safety, but information 
related to research and development is not necessarily essential for product safety assurance. It is 
the most confidential of corporate information. Therefore, R&D departments of companies should be 
excluded from th e subject of overseas inspections. Furthermore, inspections for domestic Chinese 
companies are only conducted on production sites. Japan would like to request that China stipulates 
equal treatment for both domestic and overseas companies.  
2.236.   8. Japan requests  that China ensures that confidential information will not be disclosed to 
persons other than those who are necessary for the legitimate purpose of the inspection, since 
production sites also contain a large amount of confidential corporate information. Fu rthermore, 
Japan has the following concerns on other regulations being implemented. 9. In "Specifications for 
Registration and Filing of New Cosmetic Ingredients ", there are specific requirements for nano 
ingredients and Annex 5 stipulates the definition o f such ingredients. Article 29 of "Specifications for 
Cosmetics Registration and Filing " stipulates the rule for naming of nano ingredients in product 
formulas for registration or filing and also article 27 of "Standards of Information Filing for 
Toothpaste Notification (Draft for Comments) " stipulates the rule for naming of nano ingredients in 
the product formulation table. Japan considers that a more detailed and concrete standard is 
necessary to judge which ingredients fall under the definition of nano ingredients. In addition, Japan 
would like to request that the standard be formulated in a way that reflects international trends and 
comments from all stakeholders. 10. Regarding article 33 (II) (Exemption from submitting 
toxicological testing documents) of "Specifications for Cosmetics Registration and Filing ", since the 
legal system and enf orcement system for cosmetics differ by country or region, some countries may 
not have the relevant authority. Therefore, Japan would like China to accept a certification document 
on the quality management system or good manufacturing practice qualificatio n which is issued by 
an authorized international organization or an industry association which is authorized to issue the 
certifications by government agencies of the country or region where the registering or filing 
company is located, instead of a nation al institution.  
2.237.   11. Regarding the test of freckle -removing/whitening products, Japan would like to request 
that China adopt the approach of Read -Across that was stipulated in Article 16 (freckle -
removing/whitening effect cross -reference) of "Specifications  for Cosmetic Efficacy Claim Evaluation 
(Draft for Comments) " last September. Freckle -removing/whitening is affected by active ingredients 
included in the cosmetics and the Read -Across approach will help shorten the process from 
application to permission. 12. Japan would like to request clarification so that filers of toothpaste 
products can use new toothpaste ingredients only when registrants/ filers of new ingredients have 
confirmed their use in advance during the three -year safety monitoring period after  their 
registration/filing of new ingredients, in the same manner as article 29 of "Specifications for 
Cosmetics Registration and Filing ", which stipulates the handling of new cosmetic ingredients. 13. 
Article 32 of "Standards of Information Filing for Too thpaste Notification (Draft for Comments) " 
stipulates that the abstract of an efficacy evaluation report must be submitted during the filing 
process. The "Cosmetics Supervision and Administration Regulation " stipulates that "cosmetics 
registrants or filers " are the persons responsible for efficacy of cosmetic products, however, its 
implementing regulations do not require submission of the abstract of an efficacy evaluation report. 
Japan would like to know the reason for the requirement of submitting the abs tract of an efficacy 
evaluation for toothpaste. 14. Article 36 of "Specifications for Cosmetics Registration and Filing " 
newly requires that registrants or filers retain samples of each batch of cosmetics produced for future 
inspection. It also stipulates that the number of retained samples must be able to meet the 
requirements for conducting registration and filing tests. In addition, article 31 of "Provisions for the 
Supervision and Administration of Cosmetics Production and Distribution " stipulates that cosmetics 
registrants or filers must retain samples and records of cosmetics shipped according to regulations. 
"Public notice related matters of Provisions for the Supervision and Administration of Cosmetics 
Production and Distribution " (No.140, 2021), whi ch was promulgated on 26 November 2021, 
requires that, regarding products imported to China from overseas registrants or filers, domestic 
responsible persons retain samples of each batch of cosmetics. Registrants or filers are responsible 
for cosmetics. Ja pan would like to request that China accept that samples do not have to be always G/TBT/M/86  
 
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  retained in China if the testing system can work immediately when problems with imported cosmetics 
occur.  
2.238.   15. "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 registration 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 adequate grace period of at least one year after promulgation of all relevant regulations . 
16. Article 29 of "Specifications for Cosmetics Registration and Filing " requires "Cosmetic Ingredients 
Safety Information " issued by a cosmetic ingredient manufacturer and registrants or filers must 
combine information of the raw materials used in cosme tics with "Cosmetic Ingredients Safety 
Information ". Therefore, when registrants or filers change a cosmetic ingredient manufacturer, it is 
necessary to submit the document again even if the comparability of quality and safety are confirmed 
by registrants or filers. This causes unnecessary burdens for registrants or filers. Registrants or filers 
carry out a safety evaluation of the final product based on the quality standard of materials set by 
themselves and submit the document at the time of registration or filing. It is an excessive 
requirement to require the submission of Cosmetic Ingredients Safety Information issued by 
cosmetic ingredient manufacturers. Therefore, in the same manner as international practice, Japan 
considers that the information of ing redients should be submitted when requested by the NMPA after 
launch, but not at the time of registration or filing. "Cosmetics Supervision and Administration 
Regulation " and "Provisions for Cosmetics Registration " require that relevant information on 
registration and notification management of cosmetics and new cosmetic ingredients be announced 
to the public. Japan appreciates that during the TBT official meeting in last November China stated 
that confidential company information will not be disclosed. Jap an recognizes that purchasing 
information related to cosmetic ingredients which are contained in cosmetic formulations, such as 
the name of each ingredient and its suppliers, is confidential company information. Japan would like 
to request that China clari fy that purchasing information related to cosmetic ingredients is protected 
as confidential company information and will not be announced to the public.  
2.239.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and suppor ts measures that focus on legitimate objectives, including the protection 
of human health and safety and we support the concerns raised by Members in this Committee and 
we would encourage China to ensure that facilitation of trade is considered in the impl ementation of 
the regulatory system for cosmetics, and refers China to New Zealand's statement on this trade 
concern made at the November 2021 TBT Committee, in addition to those preceding it. We would 
welcome China's response to the concerns raised by New  Zealand and other Members in this and 
other fora.  
2.240.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Australia, the United States, Korea, Japan, and New Zealand. The 
EU would like to refer to its earlier statements on this topic, in particular to the statement delivered 
in the June TBT Committee, as the EU's concerns outlined therein remain unchanged. The main aim 
of the CSAR is to ensure consumer safety. The European Union supports th is objective, however 
there is an important concern pertaining to the obligation to transmit confidential information on 
new products and their ingredients to the Chinese authorities. The mandatory disclosure of 
commercially sensitive information required in the notification and registration process, touching on 
intellectual property rights (IPR) of companies involved, remains EU's biggest concern. The EU 
believes that CSAR's requirements go beyond what is necessary to ensure consumer safety and 
traceabilit y 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 
registration purposes.  
2.241.   Other important concerns of the EU are the following. Registration of products : 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 t he production process. Notification 
for new ingredients : There are concerns 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 : manu facturers are required to make public a detailed summary of efficacy 
evaluation, which can reveal business -sensitive information. For certain efficacy claims (sunscreen, 
skin whitening/spot removal, and anti -hair loss), it is mandatory to use specified Chi nese test 
methods. Such tests must be carried out by specific testing institutions in China. For new efficacies, G/TBT/M/86  
 
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  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 suppo rt an efficacy claim in China. Extrapolation of test results 
between 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 efficacy 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 b een placed on the market in China and for which 
the claim substantiation needed to be completed until May 2022. Significantly, more transition time 
needs to be given for products already placed on the market prior to May 2022, to allow generating 
the new r equired information.  
2.242.   In response, the representative  of China  provided the following statement. 1. Safety -related 
information requirement is a common practice s of Members for safety review of health -related 
products. The required information such as the  brief description of production process, production 
process of raw material s are not subject to government information disclosure. According to the 
Regulations on the Disclosure of Government Information, authorit ies are prohibited from disclosing 
informat ion involving trade secrets and personal privacy, the publication of which may harm the 
legitimate rights and interests of third parties. Therefore, trade secrets and intellectual property 
rights will not be damaged in this regard. China attaches great imp ortance to the protection of 
business secrets. Cosmetics related regulations also require regulators to protect trade secrets both 
in the process of reviewing and that of publishing supervision related information. Authorities are 
not allowed to release tr ade secret, undisclosed information and other confidential business 
information. As for the efficacy assessment information, only a summary, not the full text of its 
supporting material is required. The required technical materials of new raw materials  only cover  
the basic aspects, rather than the complete information. The authorities will also strictly protect 
trade secrets in handling cosmetics registration.  
2.243.   2.Regarding the labelling  problem.  As a matter of fact, the Administrative Measures for 
Cosmetic L abelling does not require that all contents of the Chinese label and original label should 
correspond to each other, only requiring that the content s about product safety and efficacy claims 
indicated in the Chinese label should correspond to those of the original label. The declared efficacy 
of products is closely related to the efficacy of cosmetic ingredients. In order to prevent the practice 
of "conceptual addition", which is common in the industry, the Measures for the Administration of 
Cosmetics Label s stipulates that ingredients with weight percentage not exceeding 0.1% (w/w) 
should be labelled with "other trace ingredients" as indicating  words. "Other trace ingredients" does 
not necessarily  equal to "ineffective ingredients". They are of very low amo unt but still have certain 
effects. They can be declared in the product label upon fulfilling the relevant requirements for efficacy 
claims. As for the issue of manufacturer location, it is important that relevant information is made 
known. The cosmetics s upervision and administration Regulation clearly stipulates that applicants 
are responsible for the quality and safety of cosmetics. Measures for the Administration of Cosmetics 
Labels also require that the corresponding indicating language should be used to mark enterprise 
information, which would not lead to consumer confusions.  
2.244.   3. The Chinese cosmetics inspection method is scientifically verified and internationally used. 
Inspection method is constantly improved for updated versions. Toxicological safety  evaluation is an 
important means to examine the safety of new raw materials, necessary for protecting the legitimate 
rights and interests of consumers, to ensure the quality and safety of products. China does not 
require toxicological safety assessment to  be carried out only through animal tests. Alternative 
methods are also allowed. 4. Requirement  for inspection reports issued by accredited inspection 
institutions is in line with  the protection of the legitimate rights and interests of the consumers. 
Cosm etics used for whitening, sun protection and hair loss prevention are classified as special 
cosmetics in China. The efficacy evaluation report of such products should be submitted at the time 
of product registration. Therefore, efficacy evaluation test sho uld be completed in cosmetics 
registration and filing inspection institutions. Such institutions should be CMA accredited. Inspection 
institutions could be foreign funded ones. At present, many laboratories of foreign inspection 
institutions in China have obtained the CMA certification of cosmetics.  
2.245.   5. Based on the non -discrimination principle of WTO, the Provisions on the Administration of 
Cosmetics Registration and Filing Data put forward exactly the same requirements on imported and 
domestic ordinary cosmetics regarding alternative programme of animal test for safety evaluation. 
For both domestic and imported ordinary cosmetics, toxicological test can be replaced with safety 
risk assessment once they have obtained quality management system certification i ssued by G/TBT/M/86  
 
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  government authorities. For children's cosmetics, at present, as the skin structure and immune 
system function of growing infants and children are not perfect, safety assessment only may leave 
some unknown risks. Moreover, safety assessment data a vailable are mainly about ordinary 
cosmetics. Data about children's cosmetics is scarce. Therefore, China believes that children's 
cosmetics should be evaluated for product safety through both safety assessment and necessary 
toxicological tests. 6. The bas ic principles and requirements in "Good Practice for the Production 
quality Management of Cosmetics" are consistent with ISO 22716  and internationally adopted 
requirements, aiming to standardize the production quality management of cosmetics in China, and 
to ensure the cosmetics safety.  
2.1.3.22   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1166  (ID 
66667) 
2.246.   The representative of the United Kingdom  provided the following statement. The United 
Kingdom thanks Saudi Arabia for its continued engagement on notification G/TBT/N/SAU/1166 , 
which sets out their technical requirements for the restriction of hazardous substances in electrical 
and electronic equipment. We would first like to reiterate our previous encouragement to Saudi 
Arabia to accept self -declaration as a means of demonstrating product conformity and we refer to 
our previous November 2021 statement on this. The United Kingdom thanks Saudi Arabia for 
submitting an ad dendum notification to the TBT Committee on 10 February 2022 with guidelines 
and information about new phased implementation dates. We also thank Saudi Arabia for delaying 
the earliest implementation date to 4 July 2022 and appreciate the guidelines that h ave been 
developed to support industry in complying with the measure. It is our understanding that products 
already present and due to be placed on the market will be able to circulate until 31 December 2023; 
can Saudi Arabia please confirm if this is corr ect? And, if so, what measures will Saudi Arabia be 
taking to implement and monitor compliance with this measure? UK industry have requested clarity 
on how Saudi Arabia intends to distinguish between products placed on the market before and after 
the new r ules enter into force. We would encourage Saudi Arabia to consider allowing products 
placed on the market before 31 December 2023 to sell out. The United Kingdom appreciates the 
constructive engagement to date and we look forward to our continued productiv e interaction with 
Saudi Arabia on this matter.  
2.247.   The representative of the European Union  provided the following statement. The EU thanks 
Saudi Arabia for the bilateral meeting and the information provided therein. The European Union 
would like to reiterate  its concerns regarding the draft Technical Regulations for Restriction of 
Hazardous Substances ( "RoHS Regulations "), notified by Saudi Arabia on 1 December 2020 and 
adopted in July 2021. The EU would like to refer for details to its comments of November 2 021 and 
to the minutes of the previous TBT Committees. In particular, the EU would like to repeat the 
invitation to Saudi Arabia to reconsider the requirement of third -party conformity certification, which 
deviates from common international practice that r elies on first -party declaration of conformity. The 
EU would like to thank Saudi Arabia for the recent confirmation via Addendum ( G/TBT/N/SAU/1166/  
Add.1), that the application of the RoHS Regulation is postponed by six months (to 5 July 2022) and 
for the new phased implementat ion dates for product categories. The EU stresses the importance of 
granting sufficiently long transition periods, which would ensure a smooth implementation and 
adaptation for economic operators. The EU appreciates the information on the recently issued 
guidance to industry, which will have to be examined. We would be grateful if Saudi Arabia could 
provide the link to or a copy of the guidelines. The EU welcomes the confirmation that conformity 
assessment bodies not established in Saudi Arabia can be appro ved by SASO to issue certificates 
under the RoHS regulation. Any further information on the conditions for this approval would be 
appreciated.  
2.248.   The EU highlights the importance of promoting GCC harmonised requirements and their 
uniform application, as well as the mutual recognition of conformity assessment results in the region, 
instead of the proliferation of separated national RoHS regulations. The EU kindly invites Saudi 
Arabia to keep us informed on the timeframe for the adoption procedure of the draft G CC Technical 
Regulations for the Restriction of the use of certain Hazardous Substances in electrical and electronic 
equipment, notified to the TBT Committee in March 2018 ( G/TBT/N/SAU/1048 ). The European Union 
 
67 For previous statements follow the thread under ID 666 . G/TBT/M/86  
 
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  welcomes any workshop or information session with stakeholders and re mains available to further 
discuss this issue with Saudi Arabia bilaterally.  
2.249.   The representative of the United States  provided the following statement. The United States 
thanks Saudi Arabia for extending the implementation date for its "Technical Regulation  for the 
Restrictions of Hazardous Substances (RoHS) " by six months, from 5 January 2022 to 4 July 2022, 
along with a staged implementation based on product category. Further, while we appreciate SASO's 
willingness to engage with us and other stakeholders regarding this regulation to date, as well as 
for extending the implementation date, there remains a great deal of confusion on several details 
associated with the measure. We note that SASO recently provided an official guidance document 
to clarify the co mpliance process, which has been a major source of confusion for industry. We are 
still in the process of reviewing that document and look forward to continuing discussions with Saudi 
Arabia on any necessary clarifications, for instance does the list of HS  codes split up by category in 
the guidance supersede the list in the legislation, as there are differences. We would also like to 
highlight that industry also recently raised concerns that it will be required, as part of the 
requirements for demonstrating  compliance, to provide drawings and confidential and proprietary 
data concerning their products, which are considered among their valuable intellectual property. In 
fact, in light of the list of intellectual property assets in Annex 3, 2/1(E) which must a pparently be 
disclosed, some US companies are now weighing whether they will continue to sell products in Saudi 
Arabia or abandon the market entirely. We would appreciate SASO's guidance on this point, and 
specifically how it intends to ensure that informa tion requirements are limited to only what is 
necessary to assess conformity, and that any confidential information submitted will be protected 
from unauthorized disclosure.  
2.250.   Further, there remain a number of areas on which we have yet to receive clarificat ion from 
Saudi Arabia. First, we request that Saudi Arabia provide guidance regarding this measure, and 
outline plans for engagement with trading partners and private sector stakeholders to ensure such 
guidance is as clear as possible for those who must co mply with and enforce the rules, possibly in 
the form of frequently asked questions (FAQ), as has been done with other WTO Members' RoHS 
regimes. We also request that Saudi Arabia provide outreach to industry and the conformity 
assessment bodies to address  further questions on the process. Second, we have continued to urge 
Saudi Arabia to provide clarification of the precise scope of the regulation. The newly released 
guidance document lists HS codes in the six categories of goods. Can SASO confirm that thi s list is 
comprehensive and only those HS codes listed in the guidance document are subject to the 
conformity assessment requirement? The list of HS codes in the guidelines appears to include 
categories not listed in the published regulation and some HS co des in the regulation are not included 
in the guidelines. Please advise which document's list of HS codes should be followed relative to 
scope of this measure. For example, some of the HS codes in the annex cover products, such as 
batteries and semiconduct ors and other electronic component parts that are outside of the scope of 
categories covered by the final regulation. Further, the definition of hazardous substances refers to 
radioactive substances, yet none of the regulated substances are radioactive. Ca n you please clarify 
the definition of a hazardous substance (vs. radioactive)? Also, there are missing exemptions for 
certain necessary uses of the regulated substances for products in the monitoring and controlling 
equipment category. Can you also please  clarify when this information will be provided?  
2.251.   Third, we request further guidance on the process for testing whole equipment and/or critical 
components of a product. We understand that typically other WTO Members have not asked industry 
to provide test r eports on critical components as such testing requires dismantling the product and 
destroying its parts. Saudi Arabia's proposed approach, which results in added costs and delays in 
getting products to market, may be stricter than is necessary to give Saud i Arabia adequate 
confidence of product conformity. We request that Saudi Arabia provide a process for manufacturers 
to meet the RoHS requirements without providing test reports for critical components. Fourth, we 
request that the requirement for suppliers  to attach the entire technical file of supporting 
documentation proving compliance to their products, be modified to instead require a copy of the 
certificate of conformity from the conformity assessment body, as consumers will not be able to 
discern comp liance from a technical file, and the technical file likely would contain proprietary 
business information. The United States looks forward to continuing a dialogue with Saudi Arabia, 
and to providing additional information where needed to address those ar eas that require further 
guidance to minimize the trade restrictive impact on industry.  
2.252.   The representative of Switzerland  provided the following statement. Switzerland would like 
to support the interventions made by previous speakers on the Kingdom of Saud i Arabia's Technical G/TBT/M/86  
 
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  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 negat ive impact on trade for a wide range of products. We 
understand the Kingdom of Saudi Arabia's legitimate objective to protect the environment and public 
health and safety. However, these requirements seem to create unnecessary obstacles to trade: the 
testing and certification requirements deviate from common international practices which include 
supplier's declaration of conformity and technical documentations aligned to the appropriate relevant 
international standard. Furthermore, the implementation of the  requirements leads to uncertainties 
for manufacturers and conformity assessment bodies, such as regarding the scope or the process 
for testing the products or critical components. We encourage the Kingdom of Saudi Arabia to 
consider less trade -restrictive  alternatives and take international best practices into account. Finally, 
we encourage the Kingdom of Saudi Arabia to implement clear and transparent guidelines in order 
to support the implementation of these requirements.  
2.253.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. We will reply by uploading our answers in eAgenda by Friday. A technical statement was 
circulated following the meeting.68 
2.1.3.23   Indonesia - Government Regulation 28 of 2021 – Implementing Regulati on (for 
the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act" (ID 
72469) 
2.254.   The representative of the European Union  provided the following statement. The European 
Union is concerned by Regulation No. 28 of 2021 and new requirements for Indonesian National 
Standard (SNI) certification. In February 2021, the Government of Indonesia issued a Government 
Regulation No. 28/2021. This Regulation is one of the implementing regulations of the Omnibus Law 
on Job Creation (Law 11/2020) passed l ast year. Government Regulation 28/2021 aims to increase 
the competitiveness of Indonesia'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 still very complex to export to Indonesia. Certain sectors appear to be particularly 
concerned. With regard to the toys sector, articles 38 and 39  create significant challenges. Article 
38 prohibits Lspros from using third -party testing facilities. Article 39 stipulates that product 
certification bodies (Lspros) be Indonesian entities, employ Indonesian citizens, residents of 
Indonesia to assess pro duct 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. W e understand this is 
both required for scheme 1 (batch testing and pre -shipment inspection) and scheme 5 (factory 
certification).  
2.255.   This new approach appears to be implemented despite of no ministerial implementing 
regulation, which is normally required in t he Indonesian regulatory process to implement a 
Government Regulation. In terms of impact, this means that for batch testing and pre -shipment 
inspection, samples need to be taken by a Lspro employee/Indonesian resident. Due to COVID -19 
restrictions, it was  and it is still very difficult for Lspros to send personnel overseas to sample 
products or to conduct factory audits. As a result, all Lspros have either stopped overseas sampling 
or stopped overseas certification altogether. In addition, even when intern ational 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 cond ucted by 
Indonesian test institute. This is followed by scheduled conformity of production audits.  
2.256.   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 lik e to understand what measures Indonesia is putting in place to ensure that 
 
68 G/TBT/W/768 . 
69 For previous statements follow the thread under ID 724 . G/TBT/M/86  
 
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  EU spare parts can be smoothly imported into Indonesia. In addition, we would like to stress that 
EU products certified in accordance with United Nations (UN) regulations under the 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 par ts 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, Indon esia 
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 in 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. The  European Union invites Indonesia to notify to the WTO the implementing 
regulation to GR 28/2021 before going ahead with its implementation; and to provide adequate time 
for consultation with the industry considering the sweeping changes at issue. We remai n available 
to discuss the issue also bilaterally.  
2.257.   The representative of the United States  provided the following statement. The United States 
continues to have concerns, as noted at the last meeting, with the Government of Indonesia 
Regulation No. 28 of 2 021, which is the Implementing Regulation (for the Manufacturing/Industry 
Sector) to Law No. 11 of 2020 of the "Job Creation Act " (GR28/2021). We again ask that Indonesia 
suspend implementation of the measure, notify the measure to this Committee, provide a 60-day 
comment period for stakeholders, and take those comments into consideration before reissuing the 
measure. We understand that in November of 2021, Indonesia's Constitutional Court ruled the Job 
Creation Act conditionally unconstitutional and set a two-year period for replacement legislation to 
be passed. With the implementation of the Job Creation Act apparently on hold, could Indonesia 
please clarify what impact this will have on the issuance and implementation of Ministry of Industry 
(MOI) impleme nting regulations for GR28/2021? We request that Indonesia notify the MOI 
implementing regulations to this Committee in draft form to allow for stakeholder comment and 
consideration of those comments prior to finalization. Based on reports from industry, a nd our review 
of an unofficial translation of the measure, the regulation appears to mandate conformity assessment 
bodies use Indonesian citizens domiciled in Indonesia for all conformity assessment. This 
requirement would effectively negate use of oversea s inspection or testing bodies. We again ask 
Indonesia for a justification for including nationality and domicile as a requirement for product 
conformity testing. How do these requirements impact the ability to perform conformity assessment?  
2.258.   Many industri es obtain Indonesian national standards (SNI) certification by submitting 
product sampling for each shipment. At our last meeting, Indonesia confirmed that onsite inspections 
and sampling can continue only as long as Indonesian nationals are allowed to tra vel to conduct 
them. With widespread pandemic -related travel restrictions still impacting much of the world, how 
does Indonesia envision companies can comply with these requirements? As Indonesia is not 
allowing for remote factory inspections, companies th at rely on factory inspections to obtain SNI 
certification will be impacted if they have to rely on per -shipment testing. We are concerned that 
requiring collection of product samples conducted by Indonesian nationals domiciled in Indonesia 
will effectivel y halt imports, and already appears to be doing so. The United States observes that 
similar concerns were actually shared by the Indonesian delegate noted at the November TBT 
Committee meeting, on an STC related to India's automotive imports (IMS 649): "Indonesia remains 
concerned that the conformity assessment procedure as required in the document is more restrictive 
than necessary. The procedure includes audit and certification can only be carried out by BIS and 
requires factory visit as part of scheme. I ndonesia regrets that India has not taken into account the 
current pandemic situation that made factory visit impossible due to the travel ban and social 
distancing policy. Therefore, Indonesia urges India to consider the use of remote assessment in 
conduc ting factory inspection or any relaxation policy as a mean to facilitate trade and minimize 
technical barrier to trade, particularly in this difficult time. " 
2.259.   Likewise, with respect to GR28/2021, we regret that Indonesia has not taken into account 
the curre nt pandemic situation that has made factory visits impossible. Therefore, the United States 
urges Indonesia to consider resuming the use of remote assessment in conducting factory inspection 
or any other relaxation of policy as a means to facilitate trade,  particularly in this difficult time. We 
again seek clarification on whether Article 38 requires that conformity assessment bodies must also 
operate their own testing laboratories for all products required to be certified to SNIs. Industry 
stakeholders hav e reported that, in the absence of implementing regulations from the MOI, many G/TBT/M/86  
 
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  conformity assessment bodies have halted certification for foreign products, resulting in the halt of 
exports requiring SNI testing per shipment. As companies' SNI certification s based on factory 
inspection expire, those exports also will be halted because there currently is no means for foreign 
manufacturers to meet either requirement - factory inspections or per -shipment product sampling. 
We again urge 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.  
2.260.   In response, the representative of Indonesia  provided the following statement.  Indonesia 
would like to refer to its last statement in TBT November 2021 meeting that all certification process 
for technical regulations based on SNI in the industrial sector is carried out in accordance with the 
provisions stated on the related Minister  Regulation. All provisions apply equally for both domestic 
and foreign manufacturers. SNI certifications are conducted through factory inspection and sample 
are taken on -site by authorized personnel. Indonesia accepts testing result from accredited foreig n 
testing laboratories under the mutual recognition arrangement framework and availability of 
technical regulation agreement between Indonesia and its country partner.  
2.1.3.24   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 13370) 
2.261.   The representative of Indonesia  provided the following statement. The Indonesian 
Government is extending our gratitude to the Indian Government for holding several bilateral 
meetings with Indonesia in order to overcome the problems that occur in tyre products from 
Indonesia, both on the  sidelines of the TBT Committee meeting and in the Working Group on Trade 
and Investment (WGTI) meeting. However, Indonesia regrets that by this time, we have not received 
an appropriate response and solution to this problem. Indonesia is aware that India has imposed 
import restrictions on tyre products with certain types and size categories that can be produced by 
tire manufacturers in India. The policy was implemented shortly after India imposed a temporary 
import ban on tyre products to India for a perio d 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 hampered tyre exports to India, considering that the choice of tyre products that can be exported 
is highly limited and even has the potential to eliminate market access for imported tyres considering 
the various types and sizes of tyres produced by India as one of the world's main producers.  
2.262.   Although there are no official provisions governing the restric tions on the import of tyres, 
importers are required to make separate statements via electronic mail regarding import restrictions 
for certain types and size categories which have de facto hampered the export of tyre products from 
Indonesia. In addition, I ndonesia suspects that there is discriminatory treatment in implementing 
the said policy, where the policy is applied selectively by targeting certain Member states that have 
the potential to become competitors and disrupt market access for domestic tyre p roducts. In 
addition, we also intend to ask for further clarification regarding the application of a royalty policy 
or a marking fee on tyre products that use the IS Mark. Indonesia perceives 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 has no legal justification and has no relation to the protection of human health, 
safety or prevention of fraudulent practices. Indonesia views 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 Ar ticle 2.1 and Article 2.2 of the TBT 
Agreement. Aligned with this, Indonesia hopes that India may provide further clarification on these 
two issues and asks India to review the policy to ensure its conformity with the applicable provisions 
of the WTO TBT A greement.  
2.263.   In response, the representative of India provided the following statement. 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 ear lier 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 surveillance 
 
70 For previous statements follow the thread under ID 133 . G/TBT/M/86  
 
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  including the purchase of market samples and testing charges of the samples drawn from the 
factory/market.  
2.1.3.25   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 indications, 
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 34571) 
2.264.   The representative of the United States  provided the following statement. It is incredibly 
disappointing that the United States must again raise its concerns with the European Union's 
revisions to its draft regulation on geographical indications and traditional terms for wine; and 
specifi cally, our industry's pending applications for traditional terms which were submitted to the EU 
well over 11 years ago. The EU has failed to provide sufficient transparency about this process and 
has hindered market access for our exporters for over a deca de. The EU's persistent failure to provide 
any information leaves us no choice but to raise this issue here again at the WTO TBT Committee. 
For the past three years of TBT Committee meetings, the United States has asked the EU to tell us 
where it is in the  process of reviewing the applications. We ask again: Are the applications being 
actively considered, or have they been put on hold? What is the timeline and process for review? 
Also, at the last six TBT Committee meetings, we have asked for transparency a bout the status of 
other applications so that we can see how our applications compare. We ask again: How many 
applications for traditional terms have been lodged over the last 11 years? How many of those 
applications have been approved, rejected, or remain  pending? What is the average time between 
application and a final decision? For pending applications, how long have they been waiting? For 
pending application, how many of the applications have come from member States? How has the 
processing of these appl ications changed, if at all, over the last three years following the adoption 
of Implementing Regulation 2019/34? Does the EU intend to answer these questions which have 
been posed repeatedly since November 2019?  
2.265.   We also have additional questions that have  gone unanswered including the following: Could 
the EU confirm that US producers can continue to use any generic term, such as a grape variety, 
that is part of a compound term protected as a GI by the EU? For example, could US producers still 
use the grape  variety "Dolcetto, " even though the EU protects the compound name "Dolcetto 
d'Alba? " How do third countries find out about amended changes with respect to EU Protected 
Designations of Origin (PDO) and Protected Geographical Indications? What is the defini tion of 
"generic? " Lastly, will the revised regulation alter the ability of US producers to use terms such as 
"barrel aged " as provided for in Appendix II of the Protocol on Labelling to the 2006 US/EU Wine 
Agreement? In its response to our TBT comments, t he EU indicated that "consumers' expectations 
have been taken into account by reserving some labelling particulars concerning specific production 
methods. " Based on this response, we remain unsure if the term "barrel aged " can still be used and 
ask that th e EU please clarify.  
2.266.   The representative of New Zealand  provided the following statement. We refer the European 
Union to New Zealand's statement on this trade concern made at the November 2021 TBT 
Committee, and those preceding it. We will upload our full s tatement on eAgenda. A technical 
statement was circulated following the meeting.72 
2.267.   In response, the representative of the European Union  provided the following statement. 
The EU understands the continued interest of the United States and New Zealand in thi s issue. The 
EU has completed the revision of its internal legislation on traditional terms discussed in previous 
TBT Committees leading to the adoption of Commission Delegated Regulation (EU) 2019/33 and 
Commission Implementing Regulation (EU) 2019/34. Th e 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 specifi c Members' concerns in this area either via its internal legislation or via bilateral 
agreements.  
 
71 For previous statements follow the thread under ID 345 . 
72 G/TBT/W/770 . G/TBT/M/86  
 
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  2.1.3.26   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 42873) 
2.268.   The representative  of the Republic  of Korea  provided the following statement. The Republic 
of Korea would like to appreciate China's kind explanations on the revised Regulations for the 
Supervision and Administration of Medical Devices given in the last TBT Committee meetings of June 
and N ovember 2021. At the last TBT Committee meetings in June and November 2021, China 
explained as follows: "The new revision [...] has been released, and took effect on 1 June 2021. The 
new regulation reasonably sets clinical evaluation requirements, simplifi es the review procedures, 
and further encourages the innovation. Meanwhile, the regulation fully implements the system of 
registrant, strengthens the responsibility of enterprises and supervision over the whole process of 
medical devices." Korea fully unde rstands China's explanations and the objective of the revision. 
However, what Korea requested was clarification on the unclear definition or scope of "qualified 
testing laboratories" stated in the revised Regulations. Accordingly, Korea would like to once again 
request China to provide a response on whether internationally accredited test laboratories are 
included in China's definition of qualified testing laboratories, and further request China to include 
internationally accredited labs or overseas labs in  its definition of qualified laboratories. At the last 
TBT Committee meeting in June 2021, China responded operational rules including the requested 
clarifications are being drafted. However, Korea has yet to receive further update from China, and 
thus req uests China to share the current progress of the development of the rules.  
2.269.   In response, the representative  of China  provided the following statement. The newly revised 
Regulations on the Supervision and Administration of Medical Devices came into effect on  1 June 
2021. 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.  
2.1.3.27   China - Registration Fees for Drugs and Medical Device Products (ID 46674) 
2.270.   The representative  of the Republic of Korea  provided the following statement. As in the 
previous TBT Commit tee meetings, the Republic of Korea would like to raise this STC regarding 
China's Registration Fees for Drugs and Medical  Device Products. In the last meetings, Korea 
repeated its concerns over the difference of registration fees between imported and domestic 
products. In response, China answered that its registration fees are lower than the global average 
and there can be m inor differences. Korea however would like to reiterate that Korea's concern is 
about the significant discrepancy in fees, not the higher registration fee, in particular, for imported 
medical devices. As for Class III medical devices, the fee for imported medical devices is double that 
of domestic ones. We believe this is not a minor difference even if we take China's rationale from 
the last meeting into consideration, which is the different cost of the conformity assessment or 
workload. Moreover, China res ponded its registration fee is in compliance with common international 
practices. However, countries such as Korea, the United States of America, Canada, and Australia 
impose the same amount of registration fees on both domestic and foreign manufacturers. Korea 
requests China to do likewise and ensure fair and equitable treatment.  
2.271.   In response, the representative  of China  provided the following statement. First I would like 
to refer to our previous response to Korea's questions in previous meetings. At prese nt, the pricing 
authorities are investigating and evaluating the implementation of the registration fee policies and 
standards for drugs and medical devices , according to the Administrative Measures for Drug and 
Medical Device Registration Fee Standards, w ith the support of the National Medical Products 
Administration.  
2.1.3.28   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 50275) 
2.272.   The repres entative of the European Union  provided the following statement. The EU thanks 
Indonesia for the informative session of 7 March 2022 on the implementation of Halal assurance in 
 
73 For previous statements follow the thread under ID 428 . 
74 For previous statements follow the thre ad under ID 466 . 
75 For previous statements follow the thread under ID 502 . G/TBT/M/86  
 
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  Indonesia. The European Union reiterates its serious concerns on the Indonesian  Halal Product 
Guarantee Law No 33 of September 2014 and its implementing provisions, which require mandatory 
Halal certification and labelling for a very wide range of products to be placed on the Indonesian 
market, resulting in significant obstacles to E U 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 202 2, Indonesia adopted Regulation N° 2/2022 on International Cooperation on Halal 
product assurance ( G/TBT/N/IDN/139 ) before the expiration of the 60 -day commenting period at 
the TBT Committee. In a similar way, the EU stresses that Indonesia adopted Decree 1360/2021 on 
materials exc luded from the Halal certification obligation ( G/TBT/N/IDN/140 ) on 27 December 2021, 
even before notification to the TBT Committee on 6 January 2022, without respecting the period for 
comments. The EU encourages Indonesia to notify any relevant technical measures when still in 
draft form and to provide sufficient time for comments to be taken into account, as provided in 
Article 2.9.4 the WTO TBT Agreement. In addition, Members are required, in accordance to Article 
2.12 of the TBT Agreement, to allow a reasonable interval of no les s than six months between the 
publication of the measure and its entry into force, except if this would be ineffective for fulfilling 
the legitimate objectives pursued.  
2.273.   The EU kindly invites Indonesia to provide a written reply to its comments of 12 May 20 20 
on Regulation 31/2018 on Processed Food Labelling ( G/TBT/N/IDN/124 ). The EU thanks Indonesia 
for the consolidated written reply of 7 March 2022 covering several Members' comments on the 
following measures: (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 excl uded from the Halal 
certification obligation. The replies are under examination by the EU. The EU stresses the excessive 
restrictive impact on trade of the adopted Halal law and implementing provisions and invites 
Indonesia to consider less restrictive alt ernatives to the current, wide -ranging mandatory Halal 
certification and labelling, in order to pursue the legitimate objective of ensuring reliable 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 requirements 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 foreign 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 excessive burden for economic operators 
and not allow for smooth trade relations. The EU looks forward to exploring m ore feasible and agile 
options. Clarification on transitional provisions for existing certificates would also be welcomed.  
2.274.   The exclusion of end -products from the coverage of foreign certification and the additional 
registration requirement for Halal certif ications of certain products by foreign bodies also appears to 
be unjustified, costly and duplicative. In addition, the EU is concerned about the possibility of 
imposing much higher Halal certification fees for goods and services from foreign business. The  EU 
would also appreciate further clarifications on the criteria used for the list of materials excluded from 
the Halal certification obligation and the procedure to review the list. The EU stresses the importance 
of ensuring the continued possibility to p lace non -Halal products on the Indonesian market and urges 
Indonesia to review the Halal measures in order to adopt a more trade -friendly approach. Notably, 
the EU firmly calls upon Indonesia to: limit Halal requirements to food and beverages; avoid the 
excessively burdensome requirement for mandatory "non-Halal" information as regards non -Halal 
products; and clarify its approach to international cooperation on Halal and provide for a flexible and 
pragmatic process for the recognition of foreign Halal certi fication bodies and acceptance of foreign 
certificates, building on existing bilateral cooperation and working arrangements on Halal 
certification. The EU reiterates its willingness to further discuss and cooperate on Halal issues with 
Indonesia, with the aim of finding a practical way forward and solve trade concerns.  
2.275.   The representative of the United States  provided the following statement. We note that 
Indonesia held a video conference earlier this week with BPJPH, and while we appreciated the 
informatio n, we would have appreciated an opportunity to ask questions to clarify the responses and 
to discuss our individual concerns with each of the relevant notifications. As our questions were not 
answered, we again urge Indonesia to continue bilateral engageme nt with other WTO Members and G/TBT/M/86  
 
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  industry stakeholders, and we hope to continue these discussions in the days to come. 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 since 2015 
to ensure that objective is achieved in a way that is consistent with Indonesia's WTO obligations. 
We refer Indonesia to our previous statement from November's TBT Committee, submitted as 
Working Document 761, G/TBT/W/761 . We hope to receive a response to our many unanswered 
questions and as such, have not repeated all of them here. Our comments on Indonesia's 
Notifications on Halal Product Assurance Law No. 33 of 2014 and its implementing measures, 
including Government Regul ation No. 39/2021, are as follows.  
2.276.   Transparency : We respectfully remind Indonesia of the obligation to notify draft measures 
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.  We continue 
to see a pattern with regard to halal decrees and regulations, whereby measures are finalized without 
an opportunity for stakeholder comment. For example, we note that while the regulation in 
G/TBT/N/IDN/139  was notified on 1 December 2021 with a deadline to receive co mments on 
30 January 2022, the measure was signed into law as Ministry of Religious Affairs Regulation 2 of 
2022 on 6 January 2022. Additionally, we have learned that the regulation notified as 
G/TBT/N/IDN/140  was signed into law on 27 December 2021, as Ministry of Religious Affair s Decree 
1360 of 2021, before it was notified to this Committee as a draft on 6 January 2022. By finalizing 
these regulations before the end of the comment period, or prior to notification, and before 
stakeholder comments could be received or taken into ac count, Indonesia has again missed the 
opportunity to receive valuable feedback from stakeholders on their concerns regarding the 
measures' impact on trade. We further note that two additional implementing measures of the Halal 
Law and Government Regulation  39 of 2021 (GR39/2021) that been signed into law without being 
notified, namely: BPJPH Decree 57 of 2021, which appears to be the ministerial implementing 
regulation for the Halal Law; and BPJPH Regulation 141 of 2021, which is a fee structure for Halal 
certification and accreditation. We ask that Indonesia honour its transparency obligations by 
notifying these measures to the Committee as soon as possible and halting their implementation 
until stakeholder comments can be taken into account.  
2.277.   Government to government MOU : With regard to Indonesia's most recent notification, 
G/TBT/N/IDN/139 , regarding international halal cooperation, the draft decree, unfortunately, has 
not provided clarity about the nature or need for a government -to-government MOU. In the US 
market, the United State s Government does not accredit halal certifiers or certify products as halal, 
but instead halal inspection and certification are carried out by private, US -based, halal certification 
bodies for both the domestic and export markets. Exporters rely on these US-based halal certifying 
bodies to certify that all exports conform with Indonesia's halal requirements. The system has 
functioned this way for decades without issue and we have still not received a justification for why 
that system should not continue. U nder this previous system, US -based halal certification bodies 
applied for recognition directly with the Government of Indonesia. The G/TBT/N/IDN/139  draft 
Decree appears to contain provisions for overseas non -government certification bodies to enter into 
a recognition agreement wi th BPJPH. We ask that Indonesia allow the five US -based halal certifiers 
to continue to apply for recognition directly without the requirement of a government -to-government 
MOU.  
2.278.   Additional requirements : We also understand that with regard to additional req uirements, 
Indonesia's Constitutional Court has recently ruled the Omnibus Job Creation Law conditionally 
unconstitutional and set a two -year period for replacement legislation to be passed. Can Indonesia 
please explain how this court ruling will affect th e implementation of the Halal Law?  We also request 
that Indonesia elaborate on how GR39/2021 and its related implementing regulations supersede 
previously instituted measures. For example, MUI maintains a list of ingredients that are deemed to 
be non -critical to halal product certification, while MORA has notified a separate list of such 
ingredients in the MORA Draft Decree of the Minister of Religious Affairs Regarding Materials That 
Excluded From Halal Certification Obligation ( G/TBT/N/IDN/140 ). We urge BPJPH to work with MUI 
and other relevant government agencies, such as BPOM for cosmetic and food ingredients, to ensure 
that these lists do not conflict with one another and that manufacturers can easily determine which 
ingredients are deemed non -critical. We also ask that Indonesi a develop a transparent and timely 
process for industry to petition for the addition of new non -critical ingredients, as such a process 
could be used to avoid the creation of unnecessary obstacles to trade.  We also urge BPJPH to 
coordinate with other Gover nment of Indonesia Ministries to ensure forthcoming implementing G/TBT/M/86  
 
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  regulations for the Halal Law do not contradict existing regulations, and ask that Indonesia clearly 
indicate when and to what extent an implementing regulation supersedes existing regulation s. 
2.279.   We have asked about the certification of services over the course of several years and still 
have no clear idea of how that will function. We have concerns about the possible requirement that 
Indonesia intends that all transportation, packing, storage, and  delivery services related to food, 
beverages, cosmetics, and medical devices must be certified halal. Requiring these services to be 
certified as halal could be problematic and possibly unfeasible for US industry, given the breadth 
and scope of these serv ices and the lack of clarity from Indonesia about what those requirements 
might mean. A concern that we have long noted but have yet to receive a sufficient response on is 
that the halal measures would mandate that halal and non -halal products be separated  across the 
entire supply chain, including storage, transportation , distribution and sales. These requirements 
will be extremely burdensome and we question their necessity, as product packaging, traceability, 
and other means are available to ensure the int egrity of halal products. The United States requests 
that Indonesia remove these requirements, as contained within GR 39/2021. Please explain why 
Indonesia has not worked with industry on developing procedures or requirements by product type, 
as originally  envisioned? For example, requirements for the management of fresh food will likely 
differ significantly from requirements relating to many of the other products to be certified.  Finally, 
we have noted that requiring each individual business operator to em ploy a halal supervisor is an 
overly burdensome requirement raising serious concerns about its impact on international trade. A 
likely outcome of this requirement is that small and medium -sized enterprises that cannot afford to 
retain a halal supervisor wi ll instead choose not to do business in Indonesia.  
2.280.   Conclusion : In conclusion, many of the other concerns we have raised at past meetings have 
not been sufficiently addressed by Indonesia. For example, we have asked questions about: why 
genetically engineer ed products are required to be certified by BPJPH when MUI exempted them; 
justifications for requiring all products to certify as halal or non -halal, when no halal claims are 
made; requiring colour -coding of haram ingredients on labels; what halal certific ation services will 
look like; Indonesia's intended process and timeline for renewing existing accreditations and adding 
new US -based halal certifiers; and many more for several meetings with no response. To allow US 
industry time to adjust to these new re quirements, 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 unnecess ary obstacles to international trade.  
2.281.   The representative of Australia  provided the following statement. Australia welcomes 
ongoing discussions on the Indonesian Halal Product Assurance Law no.33 of 2014 (Halal Law) and 
continues to seek for the law to be i mplemented transparently and in close communication with 
businesses and trading partners. We encourage Indonesia to continue to facilitate an open dialogue 
with trading partners to allow foreign businesses and their valued Indonesian importers to remain 
adequately informed of Halal Law implementation regulations. Australia is eager to ensure that our 
existing 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 appreciated the 
opportunity to provide formal comments on Indonesia's latest Draft Regulation of the Minister of 
Religious Affairs Regarding International Cooperation on Halal Product Assurance 
(G/TBT/N/IDN/139 ), notified to the TBT Committee on 1 December. We look forward to Indonesia's 
response to our submission and welcome clarification from Indonesia as to whether a halal -specific 
bilateral agreement is required in order for Australian halal -certifying bodies to be recognized by 
Indonesia. Australia thanks Indone sia for the Halal Law informative information sessions provided 
recently. We welcome Indonesia's list of natural products that are exempt from the halal certification 
requirement, including fresh fruits, vegetables, grains, and dairy. We look forward to fu rther dialogue 
on the Halal Law to ensure its implementation is no more trade restrictive than necessary.  
2.282.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank Indonesia for its ongoing engagement on the implem entation of the Halal Assurance 
Law and associated implementation regulations to date. New Zealand respects Indonesia's desire to 
increase the robustness of the halal assurances associated with products moving into commerce 
within Indonesia. However, we ar e also very interested in working with Indonesia to ensure the halal 
certification controls and systems operating within New Zealand are recognized without the 
application of restrictive additional inspection, control or approval processes and associated c osts. G/TBT/M/86  
 
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  We ask for some clarity on the status of Overseas Halal Certification Bodies who were previously 
listed with MUI, and the timelines for their registration with BPJPH. Will this registration need to be 
periodically renewed? Does the same apply for Hal al Certification Bodies who were not previously 
listed with MUI who are now applying to BPJPH? Will Indonesia work directly with those countries 
with Mutual Recognition Arrangements to list those Halal Certification Bodies that these countries 
certify meet  the agreed criteria and not impose duplicate control, inspection or approval systems or 
costs? Under Minister of Religious Affairs Regulation 2/2022 on the International Cooperation of 
Halal Product Assurance, will a Mutual Recognition Agreement between t wo countries allow foreign 
Halal Certification Bodies (HCBs) approved by their halal regulatory authority in the country of origin, 
to certify products without the HCB also being required to accredit directly with BPJPH? Can 
Indonesia clarify that foreign Halal Certification Bodies in the country of origin are able to certify the 
halal status of all Raw Material, Additives and End Products as and when required? With regard to 
the recently -released Ministry of Religious Affairs regulations 748/2021, can Indo nesia please clarify 
both the criteria and the 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 product 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?  
2.283.   The representative of Canada  provided the following statement. Canada apprecia tes 
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 commen ts are taken into consideration prior 
to that measure being finalized. In addition, as per WTO obligations, a 6 -month period between the 
notification of the final measure and its entry into force is considered a reasonable amount of time 
to provide industr y time to adapt to the new requirements. Canada is concerned that the draft 
implementing regulation "Decree of the Minister of Religious Affairs of Indonesia Number 2 of 2022" 
was finalized on 6 January 2022, prior to the closing of the comment period for notification 
G/TBT/N/IDN/1 39 on 28 January 2022, during which time Canada sent comments to Indonesia. 
Similarly, while the comment period for G/TBT/N/IDN/131  ended on 12 February 2021, Government 
Regulation Number 39 of 2021, "Regarding Implementation of Halal Product Assurance", was 
finalized on 2 February  2021, prior to the end of the comment period. Canada would also like to 
express its significant concern that Canadian exporters are unable to export halal products to 
Indonesia, as a Canadian certification body's application for an extension of its accred itation has 
been pending for six years.  
2.284.   Canada has followed all relevant requirements and expects to be offered the same 
opportunity as other Members to have its halal certification body recognized while domestic reforms 
continue in Indonesia. Canada urges  Indonesia to consider how its stated requirement for a 
Government -to-Government Memorandum of Understanding prior to recognizing foreign halal 
certification bodies is inappropriate for many WTO Members, such as Canada, where there is no 
governmental manda te to oversee halal certification. This requirement creates a clear commercial 
advantage for countries with governmental oversight. Therefore, Canada requests that Indonesia 
consider allowing reasonable alternatives to the MOU requirement. Additionally, wh ile 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. Therefore, to avoid unnecessary disruptions to trade, 
Canada requests that Indonesia provide further clarity on HS Codes for the full suite of agricultural 
products impacted in its lists of products where halal certification is required. Th ere 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. Could Indonesia explain 
why frozen fish are exempt but not other frozen seafood, such as crab. Canada has been seeking to 
engage bilaterally with Indonesia, in particular with the Ministry of Religion's Halal Product Assurance 
Organizing Agency (BPJPH), for some time. Most recently, officials have been seeking a meeting  
since the arrival of the new Director of BPJPH in order to clarify the MoU requirement and discuss 
the Canadian certification body's application and we look forward to a constructive discussion.  
2.285.   The representative of Switzerland  provided the following sta tement. Switzerland is following 
this matter with interest and shares the concerns expressed by other Members regarding the 
Indonesian Halal Product Guarantee Law No 33 of 2014 and its implementing provisions, which G/TBT/M/86  
 
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  require mandatory Halal certification an d 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.  The 
implementing provisions appear to be more trade restrictive 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, among others , the "non-Halal" information requested 
for non -Halal products or the extension of Halal requirements to products other than food and 
beverages. We encourage Indonesia to reconsider the respective provisions of its recently adopted 
regulations. Furthermore, in order to ens ure 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 foreign Halal certificates. The pre -condition of a government -to-government mutua l 
recognition arrangement for recognition by Indonesia of foreign Halal certification bodies and 
certificates seems to represent a significant burden for economic operators. The additional 
registration requirement for Halal certifications of certain produc ts by foreign bodies also appears to 
be more trade restrictive than necessary. In this respect, we encourage Indonesia to provide 
flexibility for the recognition of foreign Halal certification bodies and the acceptance of foreign Halal 
certificates. Switze rland strongly encourages Indonesia to notify any relevant technical measures 
when still in draft form and to provide sufficient time for comments, in accordance with the WTO 
TBT Agreement.  
2.286.   The representative of Chile provided the following statement. The delegation of Chile would 
like to take this opportunity to thank the representative of Indonesia to the WTO for the invitation 
to a webinar on Halal regulations last Monday, and echoes the STC raised by the United States and 
the European Union in view of i ts concerns over the effects that implementation could have on the 
trade of Halal -certified products from Chile to Indonesia.  
2.287.   In response, the representative of Indonesia  provided the following statement. Indonesia 
would like to refer to its statement on t he previous TBT meeting in November 2021. In addition, 
Indonesia has conducted clarification session regarding Halal Product Assurance Implementation on 
7 March 2022 inviting WTO Members who have already submitted concerns and enquiries as well as 
interest ed stakeholders. Indonesia greatly thanks 153 participants who have joined the session for 
their time and inputs. Not solely that, BPJPH had also held several hybrid seminars for rebranding 
and socializing related regulations and policy implementation on h alal product assurances, attended 
by more than 30 embassies from fellow countries, including embassies from the US, Australia, New 
Zealand, Canada, Switzerland, and Chile; as well as halal certification agencies across the globe. 
During the session involvi ng WTO Members, Indonesia has provided detailed and thorough 
information regarding the measures of the following notifications: (i) G/TBT/N/IDN/131 ; 
G/TBT/N/IDN/131/Add.1  Government Regulation Number 39 of 2021 Regarding Implementation of 
Halal Product Assurance; (ii) G/TBT/N/IDN/134 ; G/TBT/N/IDN/134/Add.1  Decree of The Minister of 
Religious Affairs of Indonesia Number 748 of 2021 regarding Types of Products and Consumer Goods 
Products Mandatory to be Halal Certified; (iii) G/TBT/N/IDN/138  Regulation of Minister of Finance 
Number 57/PMK.05/2021 regarding Tariff for Public Services provided by Halal Product Assu rance 
Organizing Agency (BPJPH); and (iv) G/TBT/N/IDN/139  Draft Decree of Minister of Religious Affairs 
Regarding International Cooperation on Halal Product Assurance; and (v) G/TBT/N/IDN/140  Draft 
Decree of The Minister of Religious Affairs Regarding Materials Exempted from Halal Certification 
Obligation. 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 mutual acceptance in accordance with international regul ations and 
practices.  
2.1.3.29   Egypt - Manufacturer Registration System (Decree No. 43/2016 and Decree No. 
992/2015), G/TBT/N/EGY/114 , G/TBT/N/EGY/115  (ID 50576) 
2.288.   The representative of the European Union  provided the following statement. The EU would 
like to inform WTO Members that the registration requirements in Eg ypt became subject to the 
Dispute Settlement Procedure DS609 under WTO. The EU will discuss the case exclusively in the 
framework of that procedure.  
2.289.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation has r aised this issue several times during the meetings of different WTO bodies. Today 
 
76 For previ ous statements follow the thread under ID 505 . G/TBT/M/86  
 
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  we would like to welcome registration decisions made by the Egyptian authorities in respect of 
Russian exporters. We will follow with interest as a third -party developments o f the trade dispute 
initiated by the EU.  
2.290.   The representative of Turkey  provided the following statement. We want to reiterate our 
continued concern about Egypt's Decree Number 43/2016, as well as its subsequent amendments 
and extensions to the manufacturer registration system. First, we would like to thank Egypt for 
holding the bilateral discussions in Cairo to address the Turkish exporters' concerns over the 
manufacturer registration system's implementation. However, Turkish exporters continue to face 
challenges within the implementation of the registration system, including the need for hand delivery 
of documents during the COVID -19 pandemic, a lengthy registration process, the expiration of 
registered documents and the cancellation of the companies' regist ration due to expired documents. 
We have identified 115 Turkish exporters waiting for the approval, in which GOEIC has not provided 
any details on the reasons for their lengthy registration period. On the other hand, Turkey is closely 
monitoring the recent ly initiated consultations process concerning this measure under the WTO 
Dispute Settlement Mechanism. In conclusion, Turkey would like to underline its expectations from 
Egypt to terminate this measure by considering the WTO Agreements' principles and obl igations.  
2.291.   In response, the representative of Egypt  provided the following statement. Egypt has indeed 
entered into consultations in good faith with the EU on this matter as per DS 609; the Russian 
Federation requested to join the consultations. Egypt would  like to stress that it shall continue its 
positive engagement in the context of the consultations with a view to reaching an amicable mutually 
satisfactory solution. On the concerns raised by Turkey, I would like to express Egypt 's readiness to 
continue i ts bilateral exchanges with Turkey to identify the underlying reasons of the issues raised 
and provide further clarity on the status of the registration of Turkey 's factories/companies.  
2.1.3.30   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 22477) 
2.292.   The representative of the Republic of Korea  provided the following statement. Korea 
appreciates India for its explanation at the previous meeting in November last year and its recent 
decision to postpone the implementation of the Quality Control Order (QCO) on some of steel and 
steel products. However, we would like to reiterate that Korean companies still have the following 
difficulties regarding the BIS certification process required for compliance with Steel and Steel 
Products Q CO. Korean companies completed the application for IS 17404:2020 certification in 
December 2020, and despite the challenges of COVID -19, they have reached the factory audit 
consultation process thanks to the cooperation of local BIS certification agencies.  However, no more 
follow -up process has been carried out as the visit to Korea was delayed due to differences in 
opinions between two parties regarding compliance with Korean COVID -19 quarantine guidelines 
required for factory audits in Korea. As yet, it i s possible to meet the domestic demand in India but 
only for a limited amount of time. Korean steel companies are concerned that failure to obtain BIS 
certification by May 2022 could bring a steel supply shortage, which might cause a serious disruption 
in the production capacity of India's industries that demand steel as raw material.  
2.293.   Therefore, considering the delay in the certification process due to COVID -19 and the 
facilitation of exports to India, we request that India quickly introduce alternative mea sures to 
improve the certification process until the current situation improves, such as exemption from 
factory -visit inspection, substitution with paper -based audit, or sharing information on the expected 
implementation schedule for virtual/remote inspect ion procedure which is currently under review by 
the Indian Government.  
2.294.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu remain concerned about the Steel and Steel Products (Quality Control) Order, 2020 on 
electrogalvanized hot rolled and cold reduced carbon steel sheets and strips (IS 17404:2020). As 
the IS 17404:2020 entered into force last year, our companies need t o finish the mandatory 
certification procedures to acquire certifications. However, our companies are still facing the 
difficulties in receiving the on ‐site inspection visit by BIS due to ongoing impact of COVID -19 and its 
associated quarantine policies. W e appreciate India for considering introducing relevant enabling 
provisions to undertake virtual/remote inspection in steel sector. We are interested in knowing the 
 
77 For previous statements follow the thread under ID 224 . G/TBT/M/86  
 
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  current status of India's consideration and possible measures and timeline India would adop t. For 
the purpose of assisting our companies to complete the certification process under this situation, we 
would like to request India adopt more flexible alternative measures speedily, for instance, granting 
provisional certificates via virtual inspecti on and conducting physical factory inspection to issue the 
formal certificate after the quarantine policies are relaxed. We look forward to a written response 
and continuing bilateral engagements with India on this matter.  
2.295.   The representative of Japan  provided the following statement. Japan appreciates India's 
efforts to accelerate its examination procedure in BIS mandatory standards of steel products. We 
understand all the licences applied before the pandemic were granted. In addition to that, Japan 
welcome s India's comment at the previous TBT Committee regarding their consideration to introduce 
relevant enabling provisions to undertake virtual/remote inspection for BIS conformity assessment 
activities. As the pandemic is continuing in many countries, intern ational human movement is still 
widely restricted. We encourage India's further consideration and would like to know about the 
current status and possible timeline for the introduction of such alternative inspection methods.  
2.296.   The representative of the Europ ean Union  provided the following statement. The EU would 
like to support the delegations of Japan, Chinese Taipei, and Korea. India has defined and introduced 
specific standards and certification requirements for a number of products across sectors that re quire 
on-site, in person audits. The Quality Control Orders (QCOs) have protectionist orientation and are 
sending worrying signals to EU industry, EU investors, and EU member States. Once the QCOs come 
into force, they cause extra burden and economic cost to the EU industry that has to undergo 
cumbersome procedures to obtain necessary permissions and/or licences for products already 
certified under established international standards. Additionally, the QCO on Steel and Steel products 
require a physical audi t by an auditor of the Bureau of Indian Standards (BIS) in order for products 
manufactured in third -party countries to receive the approval for exports to India. The on -going 
COVID -19 pandemic and international travel restrictions linked thereto have had n egative impact on 
certification process in India, especially for foreign companies with production facilities outside India. 
The EU would like to support the introduction of virtual/remote inspection for BIS conformity 
assessment in the steel sector. Alter native inspection methods are crucial to maintain access to 
Indian market otherwise; absence of an alternative solution could adversely disrupt supply chains 
jeopardising businesses of foreign steel manufactures.  
2.297.   The Steel and Steel Products (Quality Contr ol) Order 2020 targets 145 Steel or Steel 
products and 7 goods and articles. The QCOs for majority of these products are already in force. 
However, it remains unclear to the EU which of Quality Control Orders for steel products are already 
in force. India defers from time -to-time the date of implementation of certain steel products. The 
EU would therefore, appreciate if India could provide an updated list of steel and steel products for 
which the QCOs are already in force, together with the list of steel pr oducts 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 Steel Products (Quality Control) Order of December 2020. 
Finally, does India plan to accept steel  and steel products of foreign manufacturers produced in line 
with internationally accepted standards and prune the list of steel and steel products falling under 
the QCOs?  
2.298.   In response, the representative of India provided the following statement. The prod ucts 
under mandatory certification are notified by the concerned Line Ministries (Regulator) of the 
Government of India through the issuance of Quality Control Orders (QCOs). Gradually all Indian 
Standard on steels 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 (Conformity Assessment) Regulations, 2018. Under this Scheme, factory 
inspection is a mandatory r equirement 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 t he 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) Re gulations, 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 domes tic producers or imported in the country 
is as per the Indian standards. The implementation of QCOs ensures the availability of quality steel G/TBT/M/86  
 
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  and steel products to the end -users. It saves the Indian consumers from dumping of spurious and 
defective steel an d steel products. Members are aware that the WTO recognizes the Member's right 
to implement measures to achieve legitimate policy objectives, such as protecting human health and 
safety, protecting the environment, preventing unfair trade practices, or nati onal security. The 
technical regulations/QCOs on steel and steel products have been issued based on such policy 
objectives. Hence QCOs notified by the government are not trade -restrictive but necessary to fulfil 
a legitimate objective. As far as possible, date of enforcement of QCOs is not extended from the first 
date of enforcement. However, due to exceptional cases, if there are any specific requests for 
extension, they are examined on merit. Factory inspections were on hold earlier due to restrictions 
on international travel because of the COVID -19 pandemic. At present, the nomination of BIS officers 
is being considered for carrying out the factory inspection for applications received from foreign 
manufacturers where the country to be visited is facilitat ing visits of fully vaccinated BIS officers 
who are carrying negative RT -PCR test reports, without any restrictions like quarantine and RT -PCR 
test upon arrival.  
2.1.3.31   China - Cybersecurity Law (ID 52678) 
2.300.   The representative 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 the scope of the requirements is unclear as key terms have still not been specified in 
sufficient d etail. The EU would like to request more clarity regarding several of the implementing 
measures of China's Cybersecurity Law. For example, the National Information 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 catalogues 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 guidelines as soon as possible 
and take into account the EU comments submitted during the public con sultation.  
2.301.   The EU has taken note of the publication of the Call for Comments on the "(Draft) "Outbound 
Data Transfer Security Assessment Measures" by the Cyberspace Administration of China (CAC). 
The movement of information across national borders drives t oday's global economy. Cross -border 
data transfers with protection, allow businesses and consumers access to the best available 
technology and services, wherever those resources may be located around the world. The seamless 
transfer of information with tru st, supports the growth of the global digital economy as well as the 
expansion of international trade. Companies need to be able to efficiently transfer data across 
borders in order to respond to customers' needs, deliver goods and services to consumers, p rocess 
payments and provide customer support. It is essential that regulatory frameworks for data allow 
companies to compete globally, foster the creation of new business models and ensure a level 
playing field, with legal certainty and stability, as well as the protection of personal data.  
2.302.   Conversely, the EU understands that the "Measures for Data Export Security Assessments " 
would impose broad data and server 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 measure are not well defined. While these 
terms may be defined in other pieces of legislation, the concern s 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 certa inty. The EU urges China to take on board its comments provided during 
the public consultation.  
2.303.   The EU has also taken note of the "Critical Information Infrastructure Security Protection 
Regulation", which is effective as from September 2021. The Regulatio ns provide long -awaited 
details about how critical information infrastructure operators will be designated and what their 
 
78 For previous statements follow the thread under ID 526 . G/TBT/M/86  
 
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  responsibilities will be in order to protect the security of the networks that they build and operate. 
Since the Cybersecurity Law cam e into effect in 2017, EU companies have faced uncertainty about 
whether or not they would be deemed critical information infrastructure operators and therefore face 
regulatory obligations in data security, procurement, cross -border data flows and other ar eas. 
However, the new Regulations do not resolve the overlap between the pre -existing Ministry of Public 
Security (MPS) -administered system for equipment security, known as the Multi -Level Protection 
Scheme (MLPS, now in the process of revision to MLPS 2.0 ) and the critical information infrastructure 
protection regime. The EU urges China to clarify the mutual links regarding the compliance around 
the procurement of approved equipment and software for networks at designated levels of 
sensitivity, many of whi ch would likely also be designated critical information infrastructure. The EU 
calls on China to implement the provisions in a non -discriminatory manner, respecting the principles 
of proportionality, necessity and technology neutrality, and ensuring adequa te protection of 
intellectual property (IP). Furthermore, the EU would like to repeat its previous requests for 
clarifications on the relationship with existing Multi -Level Protection Schemes and the expected 
implementation timeline. The EU requests that C hina notify draft measures concerning any sectoral 
implementation to the WTO.  
2.304.   The representative of the United States  provided the following statement. The United States 
remains very concerned about China's suite of cybersecurity and cryptography measures.  As we 
have said in prior TBT Committee meetings, this is a major concern for US companies, given China's 
intertwined requirements for conformity assessment systems for security testing, technical 
regulations, and a multi -level classification scheme laying  out requirements including mandatory 
standards and testing for the purchase of ICT goods across a wide range of commercial sectors. 
China's Cybersecurity Law entered into force on 1 June 2017, in spite of serious and long -standing 
concerns from the United  States and many other international stakeholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
sometime general in scope, and sometimes sector specific. We have many concerns regarding 
China's Cybersecurity Law and related measures, which impose far -reaching, highly trade -restrictive 
conditions on foreign ICT products through "secure and controllable " requirements, enforced by 
cybersecurity review regime checks. Such requirements are larg ely 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 Cybersecur ity Protection, " appears to repeat and elaborate upon China's MLPS.  
2.305.   Numerous other concerns have been laid out in prior interventions by the United States and 
other Members at prior Committee meetings. Additionally, the United States reiterates its serious  
concerns regarding China's Cryptography Law, which went into effect on 1 January 2020. The United 
States is concerned that this law codifies potentially far -reaching, highly trade -restrictive 
cryptography -related constraints on foreign ICT products. Becau se these issues are technically 
complex and China's approach appears to be both novel and would have a potentially widespread 
impact in the commercial sector, the United States requests that China undertake in -depth 
consultations with the US Government, ot her 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. Gi ven the broad potential impact of these standards and measures and the 
serious concerns they have raised, it is critical that China act deliberately to collaborate with all 
interested parties, and take their comments into account before adopting the drafts  as written. We 
will continue to carefully monitor China's implementation of the Cybersecurity Law and related 
measures, as well as the Cryptography Law. We look forward to continuing this important dialogue 
with you.  
2.306.   The representative of Japan  provided t he following statement. Japan continues to have 
concerns regarding China's "Cybersecurity Law " and would like to refer to the previous statement 
we made at the last TBT Committee in November 2021. Japan is additionally concerned with the 
related enforcemen t regulations. Japan requests that China provide notifications of the enforcement 
regulations to the TBT Committee and take into consideration comments from stakeholders. In 
addition, Japan requests that China provide adequate lead time from the completion  of these 
regulations to the commencement of enforcement, and to implement these measures in a 
transparent manner.  
2.307.   The representative of Canada  provided the following statement. Canada continues to have 
significant concerns with China's suite of cybersecur ity and cryptography/encryption laws and G/TBT/M/86  
 
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  related implementing regulations. Among other things, Canada is concerned with the implementing 
measures multiplication, which creates confusion and complicates businesses' ability to comply with 
all of them, due to  their unclear scope, interaction and adherence to the principles of the TBT 
Agreement. Besides the draft National Standard on Information Security Technology – Security 
Technical Requirements of Specialized Cybersecurity Product, which was notified on 21 December 
2021, when will the other regulations be notified to the WTO TBT Committee?  
2.308.   Critical Information Infrastructure (CII) Security Protection Regulations : Canada reiterates 
concerns raised in the November TBT Committee meeting, including the absence of defined criteria 
operators of CII are to use in assessing a security threat and the lack of a clear commitment to 
national treatment, MFN treatment or the use of international standards.  
2.309.   Cybersecurity Review Measures : Canada appreciates the clar ification of the cybersecurity 
review's scope to specify it covers data processing activities by "internet platform operators" (rather 
than "data operators" in the earlier draft) that may affect China's national security.  However, besides 
this clarificatio n, the final version does not respond to many other concerns and suggestions 
submitted by Canada last July, such as: better clarity regarding what constitutes Critical Information 
Infrastructure; defined criteria that operators of Critical Information Infr astructure – and internet 
platform operators – are to use in assessing a security threat; and a clear commitment to National 
Treatment, MFN treatment and the use of international standards.  
2.310.   Draft Regulations on Network Data Security : Facilitating access to  data is critical for 
innovation, funnels resources to R&D and benefits Chinese consumers.  While Canada appreciates 
the inclusion of a definition for "Important Data ", Canada recommends China explicitly list all the 
laws and regulations under which this de finition would apply, including the Cross -border Data 
Transfer Measures, and ensure no requirement is more restrictive than necessary to achieve a 
legitimate public policy objective.  Canada is of the view that additional requirements on cross -border 
data t ransfers, compared to domestic treatment of data transfers (especially regarding articles 32 -
33 and 35 -40), raises significant concerns regarding TBT Agreement, Articles 2.1 and 2.2.  In order 
to facilitate compliance for businesses, Canada seeks China's as surance there will be sufficient 
coordination between the different regulators and ensure that industry participants are not required 
to go through different security assessments with multiple regulators.  With respect to Article 35 of 
the draft (i.e. the p otential exemption of the outbound data restrictions due to a contractual/personal 
reason), could China please clarify how the exemption works? To whom and how does a company 
apply for an exemption? What are the criteria that must be met in order to receiv e an exemption?  
2.311.   Draft Measures for Security Assessment of Cross -Border Data Transfer : Canada would be 
grateful to have more details on how China will ensure respect of National Treatment, given the 
protection of data that is being transferred outside of Ch ina will be under a separate set of rules. 
How would China be able to ensure that data kept in China has to meet equally stringent 
requirements? Canada also notes that a number of articles appear to have extraterritorial scope 
(e.g. Articles 6(3); 8(2); an d 9(5)), and condition the sending of data to other jurisdictions on a pre -
assessment from Chinese authorities. How would China ensure that no requirement, like those 
related to "important data " are not more trade restrictive than necessary to achieve a le gitimate 
public policy objective?  
2.312.   The representative of Australia  provided the following statement. Australia continues to have 
concerns regarding China's Cybersecurity Law and would like to reiterate the previous statement we 
made at the last TBT Committe e in November 2021. We were pleased to make submissions to the 
Chinese Government as part of public consultations on its cybersecurity framework – including the 
Personal Information Protection Law and Data Security Law, passed in 2021. As we set out in 
Australia's submissions, 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 under these laws should only be applied consistently with 
China's WTO obligation s. 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 
operating in China to fully understand and implement their new obligations. We con tinue to urge 
China to take into account 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/86  
 
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  2.313.   In response, the representat ive 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 
organi zations. It 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 important rol e 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 and 
improved the protection skills on cybersecuri ty, which provided a security guarantee for the 
development of the network industry and technology in China.  
2.1.3.32   China - Encryption Law of the People's Republic of China by the Office of State 
Commercial Cryptography Administration (OSCCA) (ID 53479) 
2.314.   The repre sentative of the European Union  provided the following statement. The EU would 
like to reiterate its concern relating to the Cryptography Law that came into force on 1 January 2020. 
The EU remains concerned about the wide scope of the law, in conjunction w ith 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 reco gnize China's previous commitment made in 2000 that the 
cryptography -related regulation would only apply to products whose core function is that of providing 
encryption – the so -called "Year 2000 Clarification" by the State Cryptography Administration (SCA ). 
The EU calls on China to ensure that legal and regulatory requirements are based on a non -
discriminatory basis, do not favour specific technologies, do not limit market access and do not lead 
to a forced transfer of intellectual property. The EU urges C hina to guarantee the possibility for 
foreign invested enterprises (FIEs) to participate on an equal footing with domestic companies in 
the production, research, development and sale of cryptography products on its market, including 
participation by chipma kers 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.  
2.315.   The representati ve of the United States  provided the following statement. We refer to our 
previously raised statements on this STC.  
2.316.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's "Encryption Law " that enter ed into force on 1 January 2020 and would 
like to refer to the previous statement we made at the last TBT Committee in November 2021. Japan 
requests that China's regulation does not hamper foreign companies' activities or market access to 
China.  
2.317.   The repres entative of Canada  provided the following statement. As we mentioned at the 
November meeting of the Committee, Canada provided China with written comments on a draft of 
China's State Cryptography Administration's cryptography regulations, in September 2020 , and 
continues to look forward to a response. When will these regulations be notified to the WTO TBT 
Committee? Canada reiterates its request from previous meetings of the Committee, that China 
consider modifying the regulations and laws related to Encryp tion and Cryptography, to provide 
further clarity, transparency and predictability. For example, Canada seeks the definition of terms, 
clarification that international standards will be used and further precision on the measures' scope. 
Canada would apprec iate China's consideration of its comments and, once again, invites China to 
notify the draft regulations to this Committee.  
2.318.   In response, the representative 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 the organizations equally, including foreign -
invested enterprises that engage in commercial cryptography research, production, sales, service, 
import, 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 comme rcial cryptography technology 
by means of administration.  
 
79 For previous statements follow the thread under ID 534 . G/TBT/M/86  
 
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  2.1.3.33   China - National Standards on Limits of Volatile Organic Compounds for 
Furniture, G/TBT/N/CHN/1094 , G/TBT/N/CHN/1095 , G/TBT/N/CHN/1096  (ID 50980) 
2.319.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its pre vious statements on Chinese notifications G/TBT/N/CHN/1094 , 
G/TBT/N/CHN/1095  and G/TBT/N/CHN/1096 . The European Unio n would like to express concerns 
over the draft Chinese Volatile Organic Compounds (VOC) standard for furniture "Limit of Harmful 
Substances of Furniture ", which would replace standards notified to the WTO in 2015 
(G/TBT/N/CHN/1094 , G/TBT/N/CHN/1095 , and G/TBT/N/CHN/1096 ). Despite the collaboration 
between the European furni ture industries and Chinese standardization bodies on a new, improved 
version of the standard, that would take into account international standards applied in the area of 
VOC measurements, the draft Chinese standard "Limit of Harmful Substances of Furnitur e" fails to 
bring relevant improvements and presents similar concerns as the original text notified to the WTO 
in 2015. High indoor air quality is essential for the health and wellbeing of European and Chinese 
consumers. The European Union understands and supports the introduction of standards limiting the 
emissions of harmful substances from furniture. However, important concerns expressed in the EU's 
statement in November 2021 remain.  
2.320.   To recall a few, the EU believes that it is very important to harmonize  testing methods. The 
use of proven standards as a basis should be the reference for all countries and the corresponding 
testing laboratories. Test methods should be chosen by accuracy and should be science based. The 
new standard will have an important ec onomic impact on both European and Chinese producers as 
it will pose a barrier to exports. Furthermore, the requirement proposed in the Chinese draft standard 
on Individual Volatile Organic Compounds shows an arbitrary choice of thresholds and is not focus ed 
on hazardous substances. The draft standard will therefore overestimate the impact of natural 
substances normally present in wood but underestimate the impact of toxic substances. The EU is 
of the opinion that only toxicologically relevant substances sh ould be considered as the basis for 
evidence. To make sure that the standard does not hinder the use of natural wooden materials and 
water -based coatings, health -based criteria with a focus on individual hazardous substances (not on 
TVOC) should be applied . 
2.321.   Additionally, the draft Chinese standard encourages an approach where producers simplify 
the designs and functionality of the furniture produced for the Chinese market in order to pass the 
test. The volume -based approach to the testing method used in the  draft Chinese standard would 
make the final emission of the product depend on the design and functions (for example number of 
drawers) rather than the choice of raw material. A simpler design will limit the choice for Chinese 
and European design. The EU w ould like to recall that products made from natural materials and/or 
with water -based coatings will no longer be available to Chinese consumers. The Chinese draft 
standard would also pose problems for Chinese furniture manufacturers when exporting to the E U. 
This would also be the case for manufacturers producing in the EU, because they would then have 
to use organic solvent -based lacquers to pass the tests. The EU welcomes the change applying to 
formaldehyde emission, as indicated in the latest version of the standard, dated 21 October. It seems 
that the standard now follows the internationally approved method of ISO 16000 -3 (the DNPH 
method). The EU hopes that China maintains this approach and that DNPH method remains the 
chosen way to measure formaldehyde  emissions. The EU would like to ask China to share information 
about the timing for the TBT notification of the new standard.  
2.322.   In response, the representative of China  provided the following statement. Indoor decorating 
and refurbishing materials - Limit o f harmful substances of wood -based furniture (GB18584 -2001) 
specifying the release limit of formaldehyde, is the only ongoing mandatory standard regarding 
volatile organic compounds in wood furniture in China. Mandatory Standard -Limit of Harmful 
Substances  of Furniture will be released in the near future. It specifies a variety of volatile organic 
compounds in wood furniture. The types and limits of volatile organic compounds harmonize with 
the standards and regulations issued by WHO, ISO, or other internat ional organizations.  
 
80 For previous statements follow the thread under ID 509 . G/TBT/M/86  
 
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  2.1.3.34   European Union - Chlorothalonil (pesticide active substance), G/TBT/N/EU/625  
(ID 57981) 
2.323.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regarding the measure notified by the European Union (EU) 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 during the consultation periods, the regulation under 
which the marketing approval of the active substance chlorothalonil was not renewed entered into 
force in May  2020.  This decision is already having negative implicatio ns and consequences for 
banana producers in Colombia and has repercussions for an extensive domestic agricultural 
production chain.  In addition, in February  2021, the European Commission set the MRL at the 
minimum level of detection, a provision that was s cheduled to enter into force in  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.  Nor has consideration been 
given  to the concerns raised by various Members in this and other settings, and there has been no 
response either to the calls for dialogue made on a number of occasions.  Not only were these 
measures taken in the absence of sound scientific evidence and in a ma nner that was inconsistent 
with international standards, they are also being applied in a discriminatory fashion, as, in practice, 
their implementation strongly differentiates between domestic producers in the EU and foreign 
producers.  While we recognize t he human health and environmental protection objectives involved, 
these measures are being adopted without any proof that they are indeed the least trade -restrictive 
means of ensuring an appropriate level of protection.  In Colombia, the use of plant protec tion 
substances - such as chlorothalonil - is essential in agricultural production for protecting crops 
against pests and diseases and for maintaining the quality and safety of food products.  We therefore 
once again call upon the European Union to base its  decisions on science and to avoid discrimination 
in the application of these measures.  
2.324.   The representative of Brazil  provided the following statement. Brazil supports STC 579 and 
refers to its previous statements on the matter. We respectfully differ from  the EU's decision to base 
measures on a hazard -based approach, without an adequate risk analysis and with no compliance 
with long -standing scientific principles. The non -renewal of approval for chlorothalonil by the EU did 
not duly consider that it is cur rently authorized in more than 100 countries, and that the MRLs 
allowed by Codex could reach up to 70 mg/kg. We stress our systemic concern with the fact that 
some hazard -based analyses conducted by the European Food Safety Agency (EFSA) led to the non -
renewal of approvals of some substances and subsequently to the reduction of their MRLs. The 
Brazilian Health Regulatory Agency has set MRLs for chlorothalonil applied to more than 30 crops. 
The case of chlorothalonil is particularly harmful towards Brazil's producers of banana, coffee, citrus 
fruits, papaya, watermelon, among others.  
2.325.   The representative of Paraguay  provided the following statement. This concern and the 
non-renewal of the approval of chlorothalonil and other substances were 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 reiterates its cross -cutting concern 
with regard to the EU's decision not to renew t he approval of these substances without a proper risk 
analysis and without complying with scientific principles.  In the specific case of chlorothalonil, this 
low-risk substance is sold freely in Paraguay and is used in several export products as part of th e 
rotation of substances to avoid pest resistance. It is also the most common alternative for mancozeb, 
another substance whose approval was not renewed by the EU despite the fact that neither of these 
substances poses a risk to human health or the environ ment, if used in accordance with good 
agricultural practice.  As with the trade concerns on other substances and systemic concerns, we 
reiterate the request to the EU to 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.  
2.326.   The r epresentative of Ecuador  provided the following statement. Ecuador expresses its 
thanks and support for the statements of the delegations that have already taken the floor. Ecuador 
wishes to reiterate its concern in relation to notification G/TBT/N/EU/625  on the non -renewal of the 
approval of the active substance chlorothalonil and document SANTE/10186/2018 Rev 1, through 
which the European Union (EU) confirms the non -renewal of the approval of the substance.  
 
81 For previous statements follow the thread under ID 579 . G/TBT/M/86  
 
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  Chlorothalonil is one of the main tools for controlling Black Sigatoka in ba nanas owing to its 
effectiveness, low cost and multisite mode of action, meaning that the risk of resistance is low. It is 
available in a broad range of products, through many suppliers, and is widely available in Ecuador.  
Controlling Black Sigatoka (Mycos phaerella fijiensis) is the main challenge for banana production in 
Latin America. To control the disease, strategies to rotate fungicides with different modes of action 
have been pursued to avoid fungal resistance to these compounds.  A limited variety of molecules is 
available for rotation in spraying schedules. Restricting the use of chlorothalonil will further 
complicate efforts to prevent pest resistance.  Our concern stems from the fact that the non -renewal 
of the approval of chlorothalonil also resulte d in the notification of document 
G/SPS/N/EU/394/Add.1 , dated 12  February  2021, pursuant to which new MRLs came into force for 
the active substances carbon tetrachloride, chlorothalonil, chlorpropham, dimethoate, ethoprophos, 
fenamidone, methiocarb, omethoate, propiconazo le and pymetrozine.  
2.327.   Reducing the MRL for chlorothalonil could have a very significant economic impact on 
small -, medium - and large -scale producers in Ecuador, as well as on consumers in the EU, since the 
supply of our products would be affected.  Moreover, no substitute or similar phytosanitary products 
with the same environmental or toxicological profile are currently available, since the alternatives to 
chlorothalonil (mancozeb, metiram) are already under review by the EU.  The banana sector provides 
jobs f or 2.5  million people. Banana exports generate 2.1  billion in revenue for the country, 
accounting for 2% of GDP and 35% of agricultural GDP.  Furthermore, Ecuador urges the European 
Union to share whether, where emergency authorizations have been issued for  the use of this 
substance, European Union member countries have notified and justified the application of MRLs 
that differ from those established in the European Union's existing MRL regulations. If so, which MRL 
is being applied by member countries and h ow is compliance with that MRL being monitored in 
intra-European trade?  
2.328.   The representative of Costa Rica  provided the following statement. Costa Rica once again 
fully supports the comments made by Colombia and reiterates its concern regarding the measure 
notified by the European Union in document G/TBT/N/EU/625 , relating to the non -renewal of the 
approval of the active substance chlorothalonil.  Costa Rica's concern has been raised during previous 
meetings of this Committee and is based on the lack of conclusive scientific evidence and  the 
application of a precautionary approach in the processes to renew the marketing approvals, which 
then affect the establishment of MRLs. This has happened in the case of chlorothalonil, with the 
Regulation relating to this substance entering into effec t in May  2020 despite the many concerns 
raised in various WTO bodies at both the bilateral and regional level, and at an extremely difficult 
time for tropical agricultural exporting countries such as Costa Rica, which continue to feel the 
adverse effects o f the pandemic . In this respect, we support the call made by Costa Rica, Colombia 
and other WTO Members in document G/TBT/GEN/296/Rev.3  for the EU to temporarily suspend all 
review processes of market approvals for plant protection substances, as well as the entry into forc e 
of regulations in this area planned for 2020 and 2021, including the non -renewal of the active 
substance chlorothalonil.  
2.329.   The representative of Guatemala  provided the following statement. Guatemala maintains its 
position regarding this concern, and we rei terate our comments made at previous meetings on the 
lack of scientific evidence and the lack of a risk analysis. Chlorothalonil is used on more than 10 
crops for domestic consumption and export. This active substance is used as a broad -spectrum and 
fast-acting contact fungicide.  No molecule on the market is currently as effective for controlling the 
Ascochyta  fungus, above all in vegetables. Guatemala's climatic conditions provide this fungus with 
the ideal environment to reproduce, affecting crops, which have been seriously harmed, and 
Guatemalan producers and exporters and the economy. Alternative substances to chlorothalonil are: 
mancozeb, azoxystrobin, pyraclostrobin, sulphur and difenoconazole. The registration of four of 
these alternative substances w as 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.  We ask the European Uni on to 
consider the particular circumstances of tropical countries when implementing measures, until it has 
conclusive studies and has aligned itself with the provisions of the Codex Alimentarius to prevent 
these measures from becoming more trade -restrictiv e. 
2.330.   In response, the representative of the European Union  provided the following statement. As 
explained at previous meetings, the EU proposed not to renew the approval of Chlorothalonil through G/TBT/M/86  
 
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  Implementing Regulation (EU) No 2019/67782, adopted on 29 April 2019 and previously notified to 
the TBT Committee. Chlorothalonil was evaluated in accordance with Regulation (EC) No 1107/2009 
on the placing of plant protection products on the market.83 The conclusion84 by the European Food 
Safety Authority (EFSA)  on this substance was published in January 2018. During the peer review 
process, the approval criteria in Article 4 of the Regulation were not satisfied with respect to one or 
more representative uses of at least one plant protection product. Following th e 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 MRLs for chlorothalonil t o the relevant limits of 
quantification through Regulation (EU) 2021/155 of 9 February 2021.85 The new values are 
applicable to all food products since 2  September 2021 (after expiration of a 6 -month deferral of the 
application date that had been granted).  As from that date, also food products produced beforehand 
must comply with the new MRLs. Import tolerance requests, which need to be supported by 
substantial new data addressing the concerns, remain possible and will be assessed on a case -by-
case basis by  the "rapporteur " member State and the EFSA. Unless new data would be submitted 
which would address the concerns raised by EFSA, there will be no further developments in the EU 
on that substance. As regards the joint Request by several Members for the susp ension of the 
processes and entry into force of reduction of Maximum Residue Levels (MRLs) of plant protection 
products in light of the COVID -19 pandemic in documents G/SPS/GEN/1778  and G/TBT/GEN/296  
and subsequent revisions, the EU position is included in the document of 28 May 2021 with double 
reference G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315  circulated in both Committees.  
2.1.3.35   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 59486) 
2.331.   The representative of China  provided the following statement. China thanks to the EU for 
extending the transition period of the regulations d uring this special period of COVID -19. In view of 
the important role of these regulations, China continues to raise concerns. China suggests, during 
the transitional period of the IVDR, the competent authorities of EU member states could continue 
to accept  FSC applications for IVDD products. The validity of the FSC shall be consistent with the 
transition period of the corresponding product. FSC is a free sale certificate issued by the competent 
authority at the request of the manufacturer or EU agency, cert ifying that the product has been 
marked CE and is free to circulate in the EU. During the extended IVDR transition period, qualified 
IVDD products are still in circulation, so it is reasonable to continue to issue FSC for IVDD products 
during the transitio n period. During the extended transition period for IVDR, the validity of the FSC 
shall be consistent with the transition period of the corresponding product.  
2.332.   The representative of the United States  provided the following statement. The United States 
continues to support the development and enforcement of a well -defined medical device regulatory 
system that assures the safety and performance of medical devices. The United States appreciates 
the amended transitional provisions adopted by the European Parliam ent and Council of the 
European Union last year for a staggered rollout of the in -vitro diagnostics regulation (IVDR). This 
change will help ensure ongoing patient access to much needed in vitro diagnostic tools. The one -
year delay in implementation of the  Medical Devices Regulation (MDR) to May 2021, provided some 
necessary relief. However, we remain concerned about the number of Notified Bodies approved to 
assess conformity to the MDR, with only twenty -seven Notified Bodies approved as of January 2022. 
These concerns are particularly acute given the current global health environment, which has limited 
the ability of prospective Notified Bodies to pursue approval while simultaneously increasing the 
demand for medical devices.  
2.333.   We have heard from industry tha t Notified Bodies are challenged to complete product 
certification reviews in a timely manner, in some cases creating extensive queues for review 
completion and delaying manufacturers' ability to comply with the regulation. Given these delays, 
industry has  shared that as they look ahead to 2024, when products must be in full compliance, 
 
82 OJ L 114, 30.4.2019, p. 15.  
83 http://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107 . 
84 EFSA 2018 Conclusion on the peer review of the pesticide risk asses sment of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126.  https://www.efsa.europa.eu/en/efsajournal/pub/5126 . 
85 OJ L 46, 10.2.2021, p. 5.  
86 For previous statements follow the thread under ID 594 . G/TBT/M/86  
 
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  some manufacturers are reconsidering whether they can continue to operate in the EU market as 
they may not be able to certify their products in accordance with the deadlines  put forth. These 
significant delays may also impact European patients who may not have access to life -saving medical 
technologies as they await certification in the Notified Bodies. Is the Commission considering 
addressing the lengthy queues for medical d evices seeking compliance? If so, how? We hope the 
Commission will continue to work with the United States as well as stakeholders to address these 
ongoing challenges with MDR implementation to avoid unintended adverse effects on patients. The 
United State s 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 international  standards where 
possible to avoid duplicative efforts and additional burdens on manufacturers to comply with regional 
and international standards.  
2.334.   We note that in preparation for the implementation of the MDR, the Commission announced 
in January 2020 that  a new nomenclature system, the European Medical Device Nomenclature 
(EMDN) system would be created to be the basis of the European Database on Medical Devices 
(EUDAMED). EUDAMED will include a Unique Device Identifier (UDI) module. The EMDN is based on 
the CND (Classificazione nazionale e internazionali), which is not harmonized with the well -
established Global Medical Device Nomenclature (GMDN).87 GMDN was developed with the support 
of ISO and the then Global Harmonization Task Force (now the Internationa l Medical Device 
Regulators 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 Identificati on Database (GUDID). We are concerned that the 
Commission's selection of EMDN will undermine the interoperability of the two UDI systems 
(EUDAMED and GUDID) for tracking and reporting purposes and will pose several significant 
obstacles to the medical devi ce 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 duplication for industry. 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 there is  no option of mapping to GMDN. 
Could the EU explain what actions it is taking to map EMDN to GMDN?  
2.335.   The representative of Japan  provided the following statement. 1. Japan appreciates the 
October update of the MDCG Guidance publication plan. At the last TBT official meeting in November 
2021, Japan requested that public consultation be carried out prior to the publication of the MDCG, 
and that the guidance that was published be made mandatory with a transition period. The mapping 
plan for EMDN (European Medica l Device Nomenclature) and GMDN (Global Medical Device 
Nomenclature) mentioned in the MDCG guidance publication plan was still not available. Japan also 
requested that a publication schedule be set and executed. Post -marketing surveillance and vigilance 
were required by the MDR. Though the plan for publication of guidance on post -market surveillance 
and vigilance has been described, we requested that it be published promptly. Japan requests that 
the EU continue to consider this matter. 2. Since the MDR was implemented on 26 May 2021, when 
the MDR was implemented, it has become impossible to ship new products and medical devices with 
new functions to Europe. At the last TBT official meeting in November 2021, Japan explained that 
we had received reports from m any companies undergoing technical document review that there 
had been no progress for a long period of time since the start of the review and that it was not 
foreseeable that the review would be completed and certificates issued by the date of application  of 
the MDR, and that more than one year had passed since the start of the technical document review. 
Japan would like the EU to investigate the cause of this issue and explain the measures to improve 
the situation. However, no improvement has been recogni zed since we received the reports from 
some companies that it has already taken more than one year and 11 months since the start of 
technical document review. Japan would like the EU, as a regulatory authority, to continue to 
investigate the causes and tak e measures for improvement.  
2.336.   3. At the last TBT official meeting in November 2021, Japan stated that the MDR required 
strict clinical evaluation of Class I, IIa and IIb medical devices. In order to prevent the MDR from 
becoming more trade -restrictive than n ecessary, Japan requested that the EU consider simplifying 
 
87 The European Commission announced its decision to adopt CND via guidance: 
https://ec.europa.eu/health/sites/health/files/md_topics -
interest/docs/md_emdn_eudamed_nomenclature_en.pdf . G/TBT/M/86  
 
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  the clinical evaluation requirements for Class I, IIa, and IIb medical devices in the same way as 
Japan's premarket certificate or the US 510(k) regulations. Japan request that the EU continue to 
consider, for instance, the medical devices that are within the moderate risk class or the medical 
devices using technologies that have already been proven in the market to be exempted from clinical 
evaluation. 4 ．Japan welcomes that the Regulation amending a transition period for the IVD 
Regulation proposed by the European Commission was adopted by the Council of the European Union 
and the European Parliament on 20 December 2021. Japan recognizes that this will certainly result 
in an extension of the transit ion period for three to five years depending on risk classifications of 
products that need to be certified by the notified bodies. Japan would like to continuously request 
that the EU provide an adequate transition period. However, considering that the num ber of products 
that needs to be certified has increased by eight times with the change from the IVD Directive to 
IVD Regulation, there are still only six notified bodies conducting certification under the IVD 
Regulation, while there were 22 such bodies un der the IVD Directive. Also, only four guidance 
documents have been issued as of January 2022. Japan is concerned that the certification of many 
manufacturers will not be completed under the IVD Regulation by the end of the transition period 
unless suffici ent infrastructure and information needed for the certification are provided, despite the 
transition period being extended. Japan continuously requests that the EU provide a sufficient 
number of the notified bodies and guidance documents, as well as provid ing their timeline in a 
prompt manner. Japan also request that any new guidance documents issued in the future be subject 
to a transition period of at least one year, rather than being enforced immediately. 5 ．As of January 
2022, the number of harmonized st andards for MDD was 264, whereas the number of harmonized 
standards for MDR was only 14. Therefore, Japan understands that a large number of harmonized 
standards for MDR will be published in the future. At the last TBT official meeting in November 2021, 
Japan stated that the publication plan in the EU Official Journal was not disclosed, and they were 
instead suddenly promulgated. Japan requested the release of the plan for the development and 
publication of harmonized standards for MDR and IVDR. Japan reque sts that the EU continue to 
consider the publication plan and set an adequate transition period for MDR and IVDR harmonized 
standard.  
2.337.   The representative of Australia  provided the following statement. Australia also has concerns 
relating to the implementati on by the European Union (EU) of the Medical Devices Regulation (MDR) 
and In Vitro Diagnostics Regulation (IVDR). This is consistent with the concerns expressed by a 
number of Members in previous meetings. In particular, we are concerned about continued ma rket 
access for Australian organizations 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 outside Australia to access the Australian 
market. Under comparable overseas regulator arrangements, Australia allows a range of overseas 
approvals to support Australian market authorization. This includes extensive use of EU CE mark 
certification to suppo rt supply in Australia. However, if suppliers cannot access notified body services 
in the short to medium term due to the transition between regulatory systems, or maintain currency 
of certification for existing medical devices, this impacts access to the Australian market. While this 
can be addressed by seeking Australian certification, this is an expensive, and potentially prohibitive, 
regulatory duplication for many stakeholders. Can the EU provide further advice on timeframes and 
progress of designation  of notified bodies, and consideration of possible extensions, in the context 
transition to the MDR and IVDR.  
2.338.   We are concerned about the shift to the European Medical Device Nomenclature (EMDN), 
diverging from the internationally harmonized Global Medical Device Nomenclature (GMDN), creating 
technical barriers to trade, and potential difficulties for a globally harmonized Unique Device 
Identifier (UDI) system. Australia is also seeking to implement a UDI system consistent with 
international norms. The use o f the EMDN as the basis for the European Database on Medical Devices 
(EUDANMED), and GMDN for the USA's Global Medical Device Identification Database (GUDID), in 
the absence of effective arrangements for interoperability, has potential for creation of barr iers to 
trade and/or significant duplication for industry between various jurisdictions, including Australia. 
Australia would like to raise awareness of the issues arising from duplicative UDI systems for 
countries outside the EU and US, and request an upd ate on any work the EU may have undertaken 
to map EMDN and GMDN systems.  
2.339.   The representative of Canada  provided the following statement. Canada wishes to echo the 
points raised by other Members regarding the implementation of this measure, and would like to  
refer to its previous statement made at the TBT Committee in November 2021 as contained 
paragraph 2.344 of the minutes.  G/TBT/M/86  
 
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  2.340.   In response, the representative of the European Union  provided the following statement. As 
announced in previous Committee meetings, th e 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 GHTF. It is important to remind that the shift 
between the Directives to the MDR is a gradual one, facilitated by a grace mechanism that allows 
for medical 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, the Commission continues to assess 
closely the situation on the ground. In previous TBT Committee meetings, the EU announced that it 
had become apparent that,  due to the additional resources required to address the COVID -19 
pandemic, national authorities, health institutions, Notified Bodies and economic operators were not 
in a position to ensure the proper implementation of the IVDR. With only six notified bod ies 
designated and the focus shifted to pandemic urgencies, it became impossible for manufacturers to 
conduct the legally required conformity assessment procedures in time. In addition, due to COVID -
19 travel restrictions, Notified Bodies were not able to carry out the required on -site audits of 
manufacturers' premises to verify the manufacturing and other relevant processes. This risks 
significant disruption in the supply of a multitude of in -vitro diagnostic medical devices (e.g. HIV 
tests, pregnancy test s or SARS -CoV-2 tests) on the European Union market.  
2.341.   As such, and as of May 2022, a staggered set of transition periods for IVDs was proposed 
by the European Commission. The proposed amendment to the IVDR has been since agreed upon 
by the European Parliament and Council. A measure explaining the adapted tran sitional 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. Since our latest update, 
we have 27 MDR designated Notified Bodies and 6 Notified Bodies under the IVDR, with mo re 
following in the pipeline. In addition, and pursuant to a Commission Notice of January 2021 on audits 
and surveillance assessments under the MDR and IVDR, there is some more flexibility for member 
States to allow remote audits carried out by Notified Bo dies, if the conditions set out within the 
Notice are met. 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 
understand that certificat ion time under the MDR and IVDR is taking longer than certification 
previously taking place under the Directives.  
2.342.   Information gathered in the continuous market monitoring conducted by the Medical Device 
Coordination Group (MDCG) has helped us to understan d better the root causes of certain delays. 
Understandably, it seems that both industry and Notified Bodies are currently in an adjustment 
period as regards expectations arising from the new requirements, especially those regarding clinical 
evidence. In ce rtain 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 th e additional 
requested information by industry sometimes varies, which is inevitably leading to certain delays in 
original certification timelines. The MDCG will continue to closely monitor the situation on the ground 
and has established regular contacts w ith Notified Bodies and industry in this regard. It is important 
to remind that the EU does not expect to maintain the same number of Notified Bodies as currently 
existing under the Directives. Therefore, under the MDR/IVDR, the numbers will go down. Quant ity 
is not and never has been an indication of capacity. As with anything related to demand and supply, 
the market will adjust and has in fact already done so, as the 33 Notified Bodies already designated 
under the Regulations reportedly hold more than a s ignificant share of the market and have, in 
addition, considerably up -scaled their capacity. As regards implementation work, the Commission 
and member States are continuing work on implementing acts and guidelines. To date, there have 
been above 90 publish ed guidance documents, including several key guidance on the transitional 
provisions and clinical requirements.  
2.343.   On standardization, we are happy to report significant progress, with the first publications 
in the OJEU of references of harmonised standards u nder the new Regulations taking place in July 
2021. The second set was published in January 2022 and a third set is expected in the coming 
months. We want to reassure you that the Commission will continue to prioritise and encourage the 
harmonisation of in ternational standards, where possible and appropriate. Furthermore, the expert 
panels, who have a role in the conformity assessment procedures of certain high -risk products, are 
officially running and processing applications. The IVD panel is now up and ru nning, having already G/TBT/M/86  
 
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  delivered a number of opinions. In addition, the registration module of the EUDAMED database was 
made available in December 2020 and the Unique Device Identification (UDI) registration module 
went live in September 2021. The remaining  three EUDAMED modules will be made available once 
the system is fully functional. As regards the Unique Device Identification (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 upon 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 Device 
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 those characteristics. It is important to clarify that the choice of this 
nomenclature does not constitute a barrier and to avoid misinformation and confusion in this respec t. 
The EU is fully committed to ensuring that the new system provides a higher level of patient 
protection and counts on trade partners to encourage their manufacturers to meet these new 
requirements to ensure trade continuity.  
2.1.3.36   Qatar - Ministry of Public H ealth Circular regarding shelf life for cheese (ID 
60288) 
2.344.   The representative of the European Union  provided the following statement. The European 
Union would like to refer again to the Qatar's Ministry 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 in August 2021. Regrettably, these measures affected several dairy products 
exported from the EU to Qatar and the European Union would like to recall the im portance of 
addressing these concerns. During the previous TBT Committee meeting, Qatar stated that this 
matter is still under consideration by the competent authorities in Doha. The European Union is 
grateful that we had further constructive exchanges wit h Qatar on this matter where Qatar signalled 
to be working on a solution, which is planned to be offered in a near future. The European Union 
would like to thank Qatar for the constructive bilateral exchanges during the past months and we 
stand ready to co ntinue to work constructively with Qatar to resolve this important issue in due 
course.  
2.345.   In response, the representative of Qatar  provided the following statement. Qatar has taken 
note of the continued concern of the European Union, regarding Qatar's Minist ry of Public health 
circular on quality standards for certain dairy products and thanks the European Union for its interest 
in this matter. Qatar refers to prior discussions on this matter with the European Union. In particular, 
during the meeting held on 16 February during which our capital -based colleagues confirmed to the 
delegation of the European Union the suspension of the Circular in question while awaiting the 
conclusion of the internal review process. Let me take this opportunity to reiterate that these 
measures have been adopted in accordance with our international obligations and with a view to 
ensuring the quality of products available in Qatar. The protection of consumers is of primary 
importance to the Government of the State of Qatar. We would  like to assure Members that the 
relevant measures apply equally to domestic and imported products and are therefore non -
discriminatory in nature. Furthermore, any impact that such regulations may have on trade will not 
be more than necessary to contribute  to the fulfilment of the legitimate objective of protecting 
consumers. In this respect, we would like to emphasize that product -specific requirements applied 
in the State of Qatar do not prevent the importation and sale of any products that meet quality 
standards and thus do not have a significant effect on trade. This being said, we have listened 
carefully to the concerns expressed by the European Union today and will again share them with our 
capital. Also, we remain available to continue our constructiv e discussion with the European Union 
and any other interested Members to provide additional explanation where necessary.  
2.1.3.37   India - Air Conditioner and its related Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/74 , G/TBT/N/IND/110  (ID 59889) 
2.346.   The representative of China  provided the following statement. China w elcomes the recent 
decision to defer the implementation of the Air Conditioner QCO to 1 January 2023. However, India 
 
88 For previous statements follow the thread under ID 602 . 
89 For previous statements follow the thread under ID 598 . G/TBT/M/86  
 
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  has not taken any measures to solve the problem of factory audits. Therefore, China would like to 
raise concerns again as follows. 1. China  suggests that India implements alternative measures during 
the pandemic, such as temporary factory audit exemption for a limited period or virtual audit or 
audits through third -party agencies. It could address or solve the difficulties of physical inspect ion 
resulting from international travel restrictions. China would like to suggest a further meaningful 
delay of the Air Conditioner QCO due to the pandemic. 2. Air Conditioner Import Policy on 15 October 
2020, the Ministry of Commerce and Industry of India  issued an Amendment in the import policy of 
items under ITC HS Code 84151010 and 84151090 of Chapter 84 of ITC(HS),2017, Schedule – I 
(Import Policy). The import policy of air conditioners with refrigerants under HS code 84151010 and 
84151090 is amended f rom "Free" to "Prohibited ". China would like to raise concerns as follows: 2.1 
China requests India to fulfill its transparency obligations, i.e. notify the TBT Committee in 
accordance with Article 2.9 of the WTO TBT Agreement, allowing a period of at leas t 60 days for 
comments. 2.2 China requests India to explain the scientific basis and necessity of the prohibition 
for air conditioners with refrigerants.  
2.347.   In response, the representative 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 Contr ol) 
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 fro m 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. Factory inspections were on hold earlier due to 
restrictions on interna tional travel because of the COVID -19 pandemic. At present, BIS officers are 
nominated for carrying out the factory inspection for applications received from foreign 
manufacturers where the country to be visited facilitates the visit of fully vaccinated BI S officers 
carrying negative RT -PCR test reports, without any restrictions like quarantine and RT -PCR test upon 
arrival. 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 recognitio n of 
overseas laboratories will be taken by BIS taking into account the MRA (Mutual Recognition 
Agreement) with the concerned countries.  
2.1.3.38   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program (ID 61590) 
2.348.   The re presentative 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 A rabia 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. 
While the conformity assessment requireme nts differ depending on the sector, several European 
industries coincide in reporting their overly costly, burdensome and time -consuming nature. The 
sector of toys is particularly affected. The European Union would like to recall that the main concerns 
are related to the following issues: request of test reports; selection of representative item; 
extension of the validity of certificate; and products imported without GCTS (GCC Conformity 
Tracking Symbol). In conclusion, the European Union would like to invi te the Kingdom of Saudi 
Arabia to ensure efficient and less costly procedures for all products included in the new conformity 
assessment system.  
2.349.   The representative of Switzerland  provided the following statement. Switzerland remains 
concerned over the neg ative impact of the "Saber Conformity Assessment Online Platform " on 
bilateral trade with the Kingdom of Saudi Arabia. We would like to support the intervention made by 
the EU on this matter. The registration and certification process remains non -transpare nt, complex 
and time -consuming 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. Depending  on the sector, strict 
conformity assessment procedures apply for products considered in their majority to be low risk 
 
90 For previous statements follow the thread under ID 615 . G/TBT/M/86  
 
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  products. In particular for companies exporting quality products in small quantities, the registration 
and certification process leads to  disproportionate costs and documentation requirements which is 
prohibitive to enter the market. Switzerland would appreciate if the Kingdom of Saudi Arabia could 
ensure that the registration and certification process is not more strict than necessary to g ive 
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 guidelin es and to ensure that the 
requirements are applied in an equal and uniform manner. We thank the Kingdom of Saudi Arabia 
for the useful engagement with our stakeholders on this matter, such as in a webinar organised by 
the Saudi Standards, Metrology and Qua lity Organization (SASO) and the Switzerland Global 
Enterprise (S -GE) last February, and look forward to further cooperation on this matter.  
2.350.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Regarding SALEEM p rogramme, it works through the development of an integrated 
system of regulations and standards that conform to internationally recognized professional practices 
by developing a highly efficient system for measuring product safety indicator in the market t hrough 
mechanisms and procedures that comply with the technical regulations of each product, especially 
essential requirements for health of human and animals, environment protection, and ensure the 
effectiveness of the services provided by legislative and  regulatory bodies to achieve safety by 
conformity of those products to SASO Standards. Within the framework of SASO to develop 
conformity assessment activities (certification, audit and inspection, and testing activities) in the 
Kingdom of Saudi Arabia to  be one of the tributaries that raise the level of quality in the national 
industry and the safety of imported goods presented in the Saudi market. By accepting the 
conformity assessment bodies in the various conformity assessment activities, as this proce ss aims 
to ensure the efficiency of the outputs of the accepted conformity assessment bodies operating in 
the conformity verification activities within the systems and requirements of the technical regulations 
approved to provide the necessary activities a ccording to the scopes of acceptance of these bodies. 
Therefore, SASO chose to engage a notified third party responsible for granting conformity 
certificates in accordance with the international standard ISO/IEC 17067 as part of the Kingdom 
premarket appro ach. 
2.351.   Regarding Saber Platform. The main purpose of Saber is to improve the import experience 
and obtain the certificates of conformity and shipment by using one platform integrated with other 
entities. Saber has reduced the time to 1 -7 working days compare d to 7 -15 working days previously. 
Saber is implementing a series of improvements in the user experience in Saber Platform (UX 
project) and we are committed to keep improving the user experience in the platform. Saber had 
added the ability for bulk adding products and bulk applying for COC. In addition, Saber now reduced 
to steps in the platform where after adding your products you can proceed to applying for PCOC. 
Saber Platform reflects technical regulations, which had been notified to the WTO. In fact, S aber 
platform is a tool that helps local importers and local manufactories to save time and apply for the 
conformity assessments scheme and does not add more polices or requirements. The validity of the 
certificate is one year for the certificate of confor mity and three years for the Saudi quality mark as 
well as the G -Mark. However, the test report can be valid for three to five years if nothing has been 
changed in the production line or the composite of the product and can be shared with multiple 
importer s. In terms of GSO toy regulation, GCTS tracking symbol must be issued through GSO 
platform. Once the GCTS is obtained, the shipment certificates can be easily issued through Saber 
platform. We strongly advise all toys industries to contact the notified bo dies according to the GSO 
Technical Regulation for Toys scheme (listed in Saber platform). In conclusion, SASO is always happy 
to collaborate and engage with all stakeholders and we look forward to further cooperation on this 
matter.  
2.1.3.39   India – Toys (Quality Control) Order, 2020 (IND/131); Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(IND/143), G/TBT/N/IND/68 , G/TBT/N/IND/131 , G/TBT/N/IND/143  (ID 63291) 
2.352.   The representative of Canada  provided the following statement. Canada continues to remain 
unclear regarding the objective of India's  requirement that toy manufacturing sites be inspected by 
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 in India and that two thirds of all "foreign " toys in India failed a safety test and 79% failed 
 
91 For previous statements follow the thread under ID 632 . G/TBT/M/86  
 
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  electrical inspections. Given this concern, Canada is unclear how inspecting toy manufacturing sites 
is going to address this concern. Shouldn't India be more concerned that the product meets the 
health and safety requirements, and not the place of production? Inspecting the assembly line and 
how the factory looks like is not going to demonstrate that the health and safety requirement of a 
toy is met. An d if the purpose of the factory inspection is in fact product testing, what is India's 
rationale for not allowing this testing to be done by ILAC accredited labs? The Canadian industry 
continues to raise great concern with India's compliance requirements f or the Quality Control Order. 
The on -site factory audits and verification testing requirement is onerous, unnecessary, expensive, 
and virtually impossible to satisfy (even during pre -pandemic conditions). Such audits are also 
unnecessary and the failure to  provide alternatives is inconsistent with international product safety 
practices such as ISO 17067.  
2.353.   Additionally, verification testing must be performed by a lab accredited by the Indian 
accreditation body, only a few of which exist outside of India. In c ontrast, international safety norms 
allow product testing to be done 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 t he factory by Indian government auditors must be paid by the 
manufacturer, the on -site audit requirement treats domestic manufacturers more favourably than 
foreign ones. We recognize factory inspections have been suspended by the Indian Government at 
this time because of the pandemic, but our industry continues to voice concerns with the on -site 
factory audits requirement. India has indicated that they are open to having a reciprocal MRA. 
However, MRAs would not be a solution for Canada as first, we do not have similar regulatory 
requirements. Second, MRAs are considered international treaties under Canadian law and are 
therefore very complex to negotiate, implement, and modify, if needed. And third, MRAs would not 
address the full extent of Canada's concern s given that several stakeholders have their production 
located outside Canada, where we can't facilitate the MRA discussions. Canada kindly urges India to 
consider allowing product testing to be done in the country of manufacture by ILAC accredited labs. 
Canada looks forward to working with India to ensure access to safe, high quality toys from Canadian 
firms.  
2.354.   The representative of China  provided the following statement. China is the largest toy 
exporting country to India, however, many companies in China have suspended exporting toys to 
India in 2021 due to the impact of the new measure. China raises concerns as follows: 1. It is 
recommended that in order not to increase the cost of enterprises, India only selects high -risk toy 
categories for mandatory cer tification. According to the Toys (Quality Control) Order, 2020, the toys 
used by children under 14 years of age shall conform to the corresponding Indian standards. All our 
toy companies exporting to India face repeated testing, factory audits and other b urdensome 
requirements. The cost of the certification is quite high for small and medium -sized manufacturers. 
During the certification process, an additional USD 10,000  deposit, application fee, annual licence 
fee, ISI logo fee are required, increasing the  cost of the enterprise and causing obstacles to 
international trade, which is against Article 5.1.2 of the TBT Agreement. 2. It is recommended that 
the laboratory referred in this Order could include all ILAC -accredited laboratories. The Toys (Quality 
Control) order 2020 stipulates that the certification is subject to conformity testing from third -party 
laboratories. We would like to thank India for increasing to 32 accredited laboratories. But currently, 
the third -party BIS laboratories capable of toy sta ndards IS 9873 and IS 15644 conformity approval, 
are all located in India. Our company would suffer long periods of audits, which affects the testing 
efficiency.  
2.355.   3. In order not to create unnecessary trade barriers, it is recommended that foreign factories  
could be allowed to conduct factory audits virtually, and, and extend the transitional period to 1 
January 2023. The Toys (Quality Control) Order came into force on 1 January 2021. The toys 
certification is quite complicated, where factory audits are the precondition for BIS verification. With 
the international travel restrictions worldwide caused by COVID -19, in -factory audits cannot be 
carried out as usual, toys certification actually is suspended. As virtual audit is already widely used, 
it is recommend ed that virtual audits for foreign factories is allowed. 4. According to Article 5.1.2 of 
the TBT Agreement, it is suggested that India could cancel the equipment requirements for electric 
toys and other projects. In October 2020, BIS issued the document 1 0 Steps to BIS Licence for Toys, 
while step 4 stipulates that electric toy factories should be with equipment required in IS  15644:2006 
Clause 8, 9 and 10. However, expensive and technically demanding equipment is quite burdensome 
and difficult for small a nd medium -sized enterprises. Besides, the tests conducted by the above -
mentioned equipment are often done by third -party laboratories. The equipment requirement is 
therefore unnecessary and unreasonable.  G/TBT/M/86  
 
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  2.356.   Policy Condition No. 2(iii) to Chapter 95 of ITC (HS ), 2017 -schedule -I (import policy): 5. It 
is recommended that the Indian government could release the products based on the certificate of 
conformity. According to newly revised Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - 
Schedule -I (Impor t Policy), samples should be randomly sent to NABL accredited Labs for testing. 
The clearance may be given by customs until the sample testing is completed. It seriously affected 
the efficiency of customs clearance and increased the importer's storage cost s, which does not 
comply with Articles 5.1.2 and 5.2.1 of the TBT Agreement. 6. It is recommended that the Indian 
could accept the results of foreign laboratories accredited by ILAC. Imported toys must be sent to 
an independent laboratory accredited by NAB L in India, which does not comply with Article 6.1 of 
the TBT Agreement. As NABL in India is a member of ILAC, it is recommended that India could 
accept the results of foreign laboratories accredited by ILAC.  
2.357.   The representative of the European Union  provid ed the following statement. The European 
Union remains concerned about India's Toys Quality Control Order and in particular the certification 
requirements introduced by the Bureau of Indian Standards (BIS). The EU refers to its previous 
statement, but woul d like to highlight today that European industry continues to report the difficulties 
to work through the Quality Control Order especially because of the factory inspection requirement. 
In addition, European industry are facing difficulties with India's im port policy. This relates to a 
previous TBT notification ( G/TBT/IND/143 ) that we understood it was replaced by the QCO with 
regard to the specific import requirements. The European Union would like to invite India to respond 
to the concerns raised already and we remain available to have bilateral exchanges to find an 
adequate of this concern.  
2.358.   The representative 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 WT O TBT 
Committee meetings, the United States has urged India to provide a means by which US companies 
can resume shipments of toys to India. US companies remain unable to ship toys to India because 
of the Toy Quality Control Order 2020 (QCO). For example, o ne US company reports it last exported 
toys to India in the fall of 2020. The QCO makes it effectively impossible to ship toys to India because 
it requires factory surveillance inspections before a licence to import toys can be granted, but US 
factories ar e in locations where the Bureau of Indian Standards (BIS) officials are not yet conducting 
the required inspections. And this problem appears much larger than just toys, as we heard in 
November's TBT meeting, where several other STC interventions by Member s raised similar concerns 
for other products. 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 delaying US companies' exports of toys to India. 
We have already made our detailed concerns well known in previous statements, and those concerns 
remain. We therefore urge India to urgently resolve this concern raised by several Members.  
2.359.   In response, the representative of India provided the following statement. 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) Regulati ons, 2018. Under this 
Scheme, factory inspection is a mandatory requirement for the purpose of granting of licence. As 
per the product certification 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 an d 
electrical safety is allowed. Sufficient capacity for testing of toys is available in BIS laboratories and 
laboratories recognized by BIS under its 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 
into account the MRA (Mutual Recognition Agreement) with the concerned nation. The factory 
inspections were on  hold earlier due to the restrictions on international travel because of the COVID -
19 pandemic. There is no provision in the BIS Regulations to undertake virtual audits or temporary 
waiver of factory inspection requirement for conformity assessment activit ies as an alternative. 
However, at present, BIS officers are being considered for carrying out the factory inspection from 
foreign manufacturers where the country to be visited facilitates visits of fully vaccinated BIS officers 
carrying negative RT -PCR te st reports, without any restrictions like quarantine RT -PCR test upon 
arrival.  G/TBT/M/86  
 
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  2.1.3.40   Australia - Maturation requirements for imported alcohol (ID 63692) 
2.360.   The representative 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 Committee's last meeting and for its enga gement 
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 beverages must be matured in wood for a mini mum of two years before delivery 
from Customs control. This covers all beverages under tariff classifications 2208.20.10, 2208.30.00 
and 2208.40.00. Even though said Notice only refers directly to brandy, rum, and whisky, it 
encompasses tariff line 2208.40 .00 (rum and other spirits obtained by distilling fermented sugarcane 
products), under which cachaça is classified in Australia. By granting the same treatment to cachaça 
and rum, the Australian Government does not allow imports of cachaça that are not mat ured for at 
least two years in wood. Such a requirement does not relate to any quality standard or sanitary 
requirement applicable to cachaça.  
2.361.   Following a public consultation in late -2019, the Australian Border Force (ABF) further 
explored a potential aven ue to amend the Customs Act 1901 (Customs Act) that would enable the 
legitimate importation of certain alcohol products into Australia whilst retaining the maturation 
requirements for brandy, whisky, and rum. According to a more recent public consultation,  the 
Australian Government is developing an approach that is looking to retain Australia's existing 
maturation requirement for imported brandy, whisky, and rum, but would establish a list of products 
exempt from this maturation requirement. The proposed li st 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, whisky or rum to be imported into the Australian market. In order 
to avoid any confusion in the Australian market or among Australian cons umers, we support that 
none of the sugar -cane products imported to Australia (matured or unmatured) that are not 
specifically "rum" should be labelled or marked as "rum". We kindly urge Australia to clarify the 
following points, which could not be addresse d in its previous statements. Could Australia please 
confirm if this new regulation will also establish new labelling requirements for products other than 
rum, brandy and whisky? Could Australia provide timeframes for the publication of the final text?  
2.362.   In response, the representative 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 remains  committed to 
the review of the legislative framework for the importation of unmatured alcohol products under 
section 105A of the Customs Act 1901 (Customs Act). We acknowledge that the review process is 
taking longer than anticipated due to the impact of the COVID -19 pandemic and the legislative 
complexities associated with this matter. As advised at the last TBT meeting, the Australian Border 
Force (ABF) initiated a broad consultation process with all relevant stakeholders, including the 
Brazilian Embassy  in Canberra, to review its legislative framework for the importation of unmatured 
alcohol products under section 105A of the Customs Act. A public consultation paper was circulated, 
in late 2020, outlining a proposed approach to the legislative amendment.  This initial stakeholder 
engagement has identified possible legislative reform options and highlighted additional 
considerations associated with the proposed reform model. Subsequent public consultation identified 
associated complexities. The Australian G overnment is now reviewing options to resolve this matter. 
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 requirements, in accordance with 
Australia's obligation under the TBT Agreement once all necessary Australian Government processes 
have been finalized regarding this review.  
2.1.3.41   India – FSSAI's Food Safety and Standards (Food Products Standards and Food 
Additives) Regulations, 2011 and the new  implementing veterinary certificate for dairy 
products (ID 63393) 
2.363.   The representative 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 
 
92 For previous stateme nts follow the thread under ID 636 . 
93 For previous statements follow the thread under ID 633 . G/TBT/M/86  
 
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  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 . Since most European cheese is 
traditionally made with animal rennet and the veterinary certificate requires that milk products have 
not been manufactured using animal rennet, there is a de facto ban for European cheese entering 
the Indian market. Similar  difficulties arise for cheese by -products, such as whey and lactose. 
Veterinary certificates are to address sanitary (human or animal) health issues and there is no 
scientific evidence that cheese produced with animal rennet is harmful to health, or more harmful 
than cheese produced with artificial/vegetal rennet. 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 b y-products, as it was previously the case. This label 
would allow consumers to make an informed choice.  
2.364.   The representative of New Zealand  did not make a statement during the meeting. A technical 
statement was circulated following the meeting.94  
2.365.   In respons e, the representative of India provided the following statement. The provision for 
non-animal rennet in cheese manufacture is not newly introduced in FFSAI 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 bee n recently aligned with FSSR regarding the prohibition 
on the use of animal rennet. Hence, FSSAI has not introduced any new condition.  
2.1.3.42   India - Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65195) 
2.366.   The representative of the United States  provided the following statement. The United States 
once again reiterates its serious concerns with India's measure mandating "non-GM (genetically 
modified) origin and GM free certificates " for certain agricultural import s 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. 
We have proposed technical cooperation with the Food Safety and Standards Authority of India 
(FSSAI) on numerous occasions to explore alternatives to this mea sure. This invitation still stands. 
G/TBT/N/IND/168  stipulates that the "Order is applicable to only food products listed in Annex -I of 
its Order and does not apply to processed food products in general. " Yet, since the Order went into 
effect in March 2021, FSSAI has used the regul ation to limit trade of certain processed products, 
including for processed products like milled rice where the Order should have no bearing. The United 
States again urges India to withdraw this requirement, and to engage with trading partners to find 
a science-based, trade -facilitating alternative.  
2.367.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. The Indian requirement goes 
beyond what is necessary t o achieve the stated objective and puts an additional burden and costs 
on EU exporters. The EU considers that the Order is disproportionate and creates unjustified barriers 
to trade. India should explain why it considers it necessary to impose such a burde n on trading 
partners with a high prevalence of non -GM food on their domestic market and a robust regulatory 
regime governing the use of GMs. The EU underlines that in addition to the fact that only a limited 
number of the food crops referred to in the Ann exure are authorized to contain GMs, there are very 
strict traceability and labelling requirements applicable to food that contains GMOs. This allows a 
strict and effective separation between non -GM and GM products, with the exception of those 
containing G M 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%. The EU as well as India 
are both parties to the Cartagena 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 t his 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 
 
94 G/TBT/W/764 . 
95 For previ ous statements follow the thread under ID 651 . G/TBT/M/86  
 
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  provides t he necessary reassurance to the importers and to the authorities. Therefore, we consider 
that the additional certification of non -GM food is not needed and is unjustified.  
2.368.   The representative of Japan  provided the following statement. Japan shares the conce rn that 
this measure, which requires 24 agricultural products imported by India to be accompanied by a 
certificate stating that they are not genetically modified origin and do not contain genetic 
modification, would create unnecessary trade barriers and ha ve negative impacts on agricultural 
trade between India and other WTO Members.  It is regrettable that this measure was enacted in last 
March, despite the fact that other WTO Members requested India to fully consider the comments 
and concerns raised to India.  In Japan, under domestic laws, the import, distribution, cultivation and 
other general uses of genetically modified agricultural products for human consumption are 
subjected to safety evaluations, and agricultural products that are not approved by t he evaluation 
process cannot be imported nor distributed domestically.  If certain items that are already under 
appropriate control in the origin country, requiring those items to be accompanied by a certificate 
of non -GM origin or GM free is not based on s cientific principles or appropriate risk assessment, and 
this measure can be concluded as more trade -restrictive than necessary. We urge India not to 
require the attachment of certificates for foods that are properly controlled in the origin country.  
2.369.   The representative of Australia  provided the following statement. Australia thanks India for 
their ongoing engagement and cooperation regarding the use of Non -GM and GM free certificates. 
Australia recognizes the right of the Indian Government to take measures necessary to ensure the 
safety and wholesomeness of food imported into India. However, Australia remains concerned with 
this measure and reiterates that measures should be risk based and no more trade restrictive than 
necessary. Australia is concerned that  aspects of the regulation add unnecessary costs and create 
an additional regulatory burden on both Australian exporters and Indian importers. Australia 
suggests India consider adopting an alternative arrangement that can be implemented in a non -
trade rest rictive way and will gladly work with India on developing a mutually beneficial alternative 
solution. Australia welcomes and looks forward to India's continued engagement on this issue.  
2.370.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at previous TBT Committee meetings, SPS Committee meetings, and the 
Council for Trade in Goods regarding the implementation of India's August 2020 Order, which 
mandates that a non -genetically modified or GM -free cert ificate accompany imported consignments 
of 24 imported food products. As detailed in Canada's comments submitted through India's TBT 
Enquiry Point in October 2020, we are concerned that India's Order will disproportionately impact 
the ability of GM -produci ng countries to export to India and unnecessarily restrict international trade. 
Canada welcomes India's recent decision to accept Canada's attestation for non -GM certification on 
bean exports. However, Canada continues to encourage India to consider 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 India assesses 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. Until a satisfactory solution is found and to minimize potential 
trade disruptions,  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, less 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 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.  
2.371.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
support for this specific trade co ncern regarding the Order issued by the Food Safety and Standards 
Authority of India (FSSAI) requiring imports of food products to have a certificate of non -GM origin.  
The rules apply to 24 food products, requiring the submission of an official certificate  attesting that 
the imported products have not been genetically modified, but we have not identified the criteria 
considered by India for the selection of these products.  Furthermore, we endorse the comments 
made by other Members regarding India's failure to submit or identify the implementation of a 
regulatory impact assessment, scientific evidence or risk analysis underpinning the measure.  
Moreover, we are concerned that this measure may generate the unjustified assumption that 
GM foods evaluated and appr oved on the basis of sound regulatory processes are less safe than 
non-GM food products. GM products have been subjected to rigorous science -based safety G/TBT/M/86  
 
- 95 - 
 
  assessments in line with international standards, guidelines and recommendations to ensure that 
they a re considered as safe as their conventional counterparts.  
2.372.   The representative of Uruguay  provided the following statement. Uruguay recognizes India's 
right to take measures to guarantee the safety of food and the health of its population.  However, 
Uruguay w ishes to recall that there is consensus internationally that genetically modified products, 
approved by exporting countries on the basis of Codex recommendations in relation to the risk 
assessment methodology, are equivalent to their conventional counterpa rts. Therefore, in Uruguay's 
view, there would not appear to be any technical justification for the implementation of the 
certification measure proposed by India, taking into account the legitimate objective, cited in the 
Order in question, of ensuring the  safety and wholesomeness of imported food.  Bearing in mind the 
above -mentioned objective, we would like to reiterate the invitation to the delegation of India to 
notify this measure to this Organization's SPS Committee.  Uruguay wishes to stress the import ance 
of Members establishing measures based on scientific principles and particularly of applying such 
measures with the objective of minimizing the negative trade effects, in line with the provisions of 
the TBT and SPS Agreements.  Lastly, we wish to reite rate 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, 14 
months ago.  
2.373.   The representative of New Zealand  did not make a statement during the meeting. A technical 
statemen t was circulated following the meeting.96 
2.374.   The representative of Colombia  did not make a statement during the meeting. A technical 
statement was circulated following the meeting.97  
2.375.   In response, the representative of India provided the following statement. The 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 im ports 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 li nes, 
India has issued such certificates for its exports to several other countries. The Government of India 
has authorized Export Inspection Council (EIC) as the nodal agency for issuing Non -GMO certificates 
for export consignments to other countries. EIC is issuing more than 9000 Non -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 
commo dities are already being accepted 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 genetical ly engineered 
organisms/substances 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 provisions 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 certific ate 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 US, UK, Australia, Canada, Turkey , 
Iran, China, EU, including Italy, Germany, France and Thailand, are already providing requisite 
certificates.  
2.1.3.43   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 66298) 
2.376.   The representative of the United States  provided the following statement. The United States 
thanks Panama for making progress on addressing our concerns regarding the duplicative onion 
nematode testing requirement. Recent developments in Panama have raised significant concerns 
regarding the pre dictability of Panama's regulatory regime. Before the November 2021 TBT 
Committee, Panama delayed entry into force of its potato measure until 1 March 2022. However, on 
 
96 G/TBT/W/765 . 
97 G/TBT/W/766 . 
98 For previous statements follow the thread under ID 662 . G/TBT/M/86  
 
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  30 December 2021, Panama published the measure and moved the enforcement date back to 
17 February 2022, thus impacting US potatoes en route to Panama. For onions, Panama extended 
the post -harvest window from 75 days to 120 days until 28 February 2022. However, on 6 January 
2022, Panama moved the expiration date back to 31 January 2022, also impacting US onions that 
were already bound for Panama. We were concerned to find that in its updated potato measure, 
Panama did not take any concerns raised by Members of this Committee into account. The post -
harvest date window remains in place, as do th e prescriptive storage criteria. Although we have 
raised our concerns and shared technical information with Panama since 2016, Panama still has not 
explained how these are consistent with any relevant international standards, nor has it provided 
any techni cal justification for these requirements. We, again, urge Panama to suspend 
implementation of the potato and onion measures until Panama has justified the post -harvest date 
window, storage temperature criteria, and sprouting limits. Such action by Panama w ould signal to 
the US and other Members that Panama is serious about addressing our concerns.  
2.377.   The representative of Canada  provided the following statement. Canada would like to thank 
the US for once again raising this specific trade concern regarding Pana ma's new quality 
requirements for fresh potatoes established by the Ministry of Industry and Commerce on 20 
February 2020. As a long -standing supplier of fresh potatoes to Panama with year -round exports, 
Canada continues to share some of the concerns raise d by the United States. In our two last 
interventions at the June and November 2021 WTO TBT Committees, Canada indicated that 
implementing these new quality requirements could have a direct impact on our ability to export 
potatoes to Panama. Canada recogni zes that Panama has twice delayed the implementation of these 
measures to allow for further consultations with trading partners. Canada was also appreciative that 
a bilateral technical meeting was held to address elements of concern on this issue. However,  despite 
this positive engagement, Canada notes that our concerns – including restrictive time limits for 
storage and marketing, as well as a zero tolerance for sprouting – have not been taken into account 
by Panama in the latest version of its quality req uirements. Canada also notes that these 
requirements were implemented with little advance notice on 17 February 2022, and much earlier 
than the previously scheduled entry into force date of 2 April 2022. Finally, we observe that Panama 
did not notify the W TO until after these requirements had already entered into force. Canada 
continues to believe that a long -term solution that would provide a more predictable environment 
for both importers and exporters can be found through further technical dialogue. Unti l a long -term 
solution is found on the elements of concern, Canada respectfully requests that Panama indefinitely 
suspend the enforcement of this new regulation.  
2.378.   In response, the representative of Panama  provided the following statement. My delegation 
thanks the United States and Canada and notes their concerns, which I will forward to Panama City.  
Panama has been responding to comments from its trading partners, as evidenced by the extension 
granted to the entry into force of the amendment for six addition al months for potatoes, as well as 
the various meetings being held in the capital between our delegations.  We reiterate our willingness 
to work with our trading partners and to maintain open communication between authorities.  
2.379.   The representative of the United States  expressed some frustration towards Panama's 
response. The United States noted that this was Panama's response to our concern after every 
intervention in this Committee, however Panama has yet to follow up with us. The United States 
requested that  the delegate expedite the response from their capital to follow up before the 
Committee meeting concludes this week.  
2.1.3.44   Republic of Korea - Revision of Safety Conformation Criteria for Textile Products 
for Infants, G/TBT/N/KOR/678  (ID 65299) 
2.380.   The representative of the European Union  provided the following statement. The EU would 
like to thank the Republic of Korea for their engagement on this issue. As a follow -up to the meeting 
of July last year, the EU has sent contact details of conformity assessment experts to the Korean 
Agency for  Technology and Standards (KATS). The EU requests that KATS provide contacts for the 
relevant counterparts in order to discuss how best to resolve this issue with the view to having 
conformity testing, to the specific Korean rules for infant clothing, be p erformed outside of Korea by 
internationally accredited laboratories. This would also reduce the environmental impact of shipping 
tonnes of clothing to Korea for testing.  
 
99 For previous stat ements follow the thread under ID 652 . G/TBT/M/86  
 
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  2.381.   In response, the representative of the Republic of Korea  provided the following state ment. 
Korea would like to thank the EU for its concerns and comments regarding the "Requirements for 
Textile Products 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 Commit tee. With regard to the request, KATS (the 
Korean Agency for Technology and Standards) is in charge, and the EU representative had already 
requested the matter to this side, so KATS will forward response to the EU representative later.  
2.1.3.45   India - Plain Copier  Paper (Quality Order) 2020, G/TBT/N/IND/140  (ID 681100) 
2.382.   The representative of Indonesia  provided the following statement. Indonesia remains 
concerned on the implementation of Plain Copier Paper (Quality Order) 2020. Since the 
implementation of the regulation, Indonesia has not been  able to export to India due to the strict 
requirement of factory visit, which remains impossible owed to travel restrictions. India has been a 
valued partner for the export of paper products, meaning, the absence of plain copier paper exports 
to India sin ce December 2020 has resulted in considerable losses for Indonesian exporters. 
Indonesia humbly requests India to establish policies that do not impede trade, but to facilitate 
imports of products from Indonesia to meet the supply of quality paper products  in the Indian 
market. According to the statement submitted by India delegation during last TBT meeting in 
November 2021, India mentioned the possibility to establish in -person inspection mechanism as an 
alternative to factory visit audit. Following this s tatement, Indonesia asks further clarification on the 
following matters. 1.  Mechanism of implementing in -person inspection and requesting India to notify 
any policies related to an in -person inspection; 2. In -person inspection allow the use of personnel 
from foreign conformity assessment bodies who are competent, accredited, and recognized by BIS 
to carry out inspections based on the scheme established by BIS. Another option is to allow in -
person inspection to be carried out by competent quality control off icers from the relevant industry 
under remote supervision of auditors from BIS; 3. Indonesia hopes that the quarantine mechanism 
applied in Indonesia to prevent the spread of COVID -19 will not become an obstacle for Indian 
auditors to conduct factory and o n-site inspections in Indonesia's region.  
2.383.   Indonesia urges India to refer to Article 6.1 Agreement of TBT WTO in accepting conformity 
assessment result. Indonesia, therefore, requests India to accept testing results from accredited 
conformity assessment bod ies under signatory framework of international accreditation when 
implementing this regulation as a mean to facilitate conformity assessment procedure conducted by 
conformity assessment bodies in Indonesia. In this regard, a Mutual Recognition Arrangement can 
take place to ensure that testing results from accredited conformity assessment bodies in Indonesia 
can be accepted by BIS. Concerning there is no plain copier paper exported during the COVID -19 
pandemic due to stringent requirements in the regulation,  Indonesia requests India to postpone or 
provide sufficient transition time to allow industries to comply with the regulation. Indonesia asks 
India to cooperate in trade facilitation for plain copier paper product.  
2.384.   In response, the representative of India provided the following statement. Sufficient capacity 
for testing plain copier paper 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. Accreditation of laboratory as per IS/ISO/IEC 17025 
from an accreditation body which is a full member of APAC/ILAC is a prerequisite for recognition 
under BIS LRS 2020. Clause 12 of BIS LRS deals with the r ecognition of overseas laboratories. The 
decision regarding recognition of overseas laboratories will be taken by BIS taking into account the 
MRA (Mutual Recognition Agreement) with the concerned nation.  
2.1.3.46   Kingdom of Saudi Arabia - Technical Regulation for B uilding Materials – Part 4: 
Bricks, Tiles, Ceramics, Sanitary Appliances, and related products (published on the 
official gazette on 22/03/2019), G/TBT/N/SAU/993 , G/TBT/N/SAU/993/Rev.1  (ID 
698101) 
2.385.   The representative of the European Union  provided the following statement. The European 
Union remain s concerned by the difficulties related to the implementation of the Technical Regulation 
for Building Materials and in particular the Saudi Quality Mark (SQM). Since the establishment of the 
Saudi Quality Mark, the European companies are facing important challenges that has resulted in a 
de facto quantitative restriction to imports. Main concerns are related to audits; high costs; limited 
 
100 For previous statements follow the thread under ID 681 . 
101 For previous statements follow the thread under ID 698 . G/TBT/M/86  
 
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  number of certification bodies; unclear audit procedures; and yearly surveillance audits. However, 
the European Union w ould like to thank the Kingdom of Saudi Arabia for the constructive bilateral 
talks on this issue. We remain available to continue the dialogue and we are confident that this 
concern will be solved in the near future.  
2.386.   In response, the representative of the  Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia would like to thank the European Union for raising this matter and for the 
constructive bilateral meetings, including the meeting this week. As a result of these bilateral 
meetings, th e competent authority in Saudi Arabia is working on a more comprehensive response 
that involves various elements, and we will reply directly to the EU.  
2.1.3.47   Indonesia - Import quota and SNI certification requirements (ID 728102) 
2.387.   The representative of China  provided the following statement. SNI certification requirements 
lead to the delay or even failure of delivery by exporters, increase the cost of international 
transportation and performance significantly, and cause unnecessary obstacles to international 
trade.  We suggest that: 1. Indonesia should increase the number of SNI accreditation bodies and 
testing laboratories outside Indonesia, and recognize CB certificates or third -party testing bodies.  2. 
Indonesia should accept mutual recognition of conformity assessment results through bilateral 
agreements. 3. Indonesia should lift the restriction that one auditor can only audit one category in 
one factory at one time; 4. Indonesia should conduct online factory inspections during the pandemic.  
2.388.   In res ponse, the representative of Indonesia  provided the following statement. Indonesia 
would like to refer to its last statement in TBT November 2021 meeting that all certification process 
for technical regulations based on SNI in the industrial sector is carr ied out in accordance with the 
provisions stated on the related Minister Regulation. All technical regulations based on SNI have also 
been notified to TBT Committee which provide a commenting period of 60 days. Indonesia remains 
available for further bilat eral engagement with China on this issue.  
2.1.3.48   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 713103) 
2.389.   The representative of China  provided the following statement. China recognizes that WTO 
Members are legitimately entitled to p rotect the security of their 5G network. 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. It is 
recommended to use objective and product -based technical standards for risk assessment. The EU's 
reply did not address China's core concern, i.e. the non -objective risk assessment criteria based on 
the characteristics of vendors are inconsistent with the TBT Agreement, which provides that a 
technical regulation shall be an objectively definable standard based on the product characteristics. 
China would like to point out that there are international standards based on technical criteria in the 
industry (e.g. the Network Equipment Securi ty Assurance Scheme (NESAS) and Security Assurance 
Specifications (SCAS) published by Global System for Mobile Communications Association (GSMA), 
the 3rd Generation Partnership Project (3GPP), the Common Criteria for Information Technology 
Security Evaluat ion, and the cybersecurity certification standards set out in EU's 5G cybersecurity 
certification scheme specified in Regulation (EU) 2019/881). China urges that Belgium comply with 
Article 2.4 of the TBT Agreement by using internationally recognized techn ical 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 in the notified law.  
2.390.   2. For Article 105,§4, it is recomm ended to clarify certain concepts and specify the scope of 
subjects to which the risk assessment criteria apply. The EU's reply did not address China's core 
concern on this issue, i.e. the scope of parties affected by the notified law is still not clear. C hina 
urges Belgium to specify the scope of "vendor " that may be subject to risk assessment and the 
method of their designation, and to clarify the relationship between "high-risk vendors " and "high-
risk equipment manufacturer " in the notified law. China re iterates 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 characteristics of vendors. 3. For Article 105, §4, 
al.1, it is recommended to specify the procedures to revoke the identification of HRV. The notified 
 
102 For previous statements follow the thread under ID 728 . 
103 For previous statements follow the thread under ID 713 . G/TBT/M/86  
 
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  law does not specify the scope and method where the HRVs are prohibited or restricted, nor does it 
illustrate the legal basis and the detailed procedures to seek remova l of the HRV designation. 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 
discrimination against specific 5G equip ment vendors. In this regard, China recommends that 
Belgium further clarify the specific scope, legal basis and procedures for prohibiting and restricting 
the HRVs from supplying 5G equipment or services, and specify the path for so -called HRVs to seek 
removal of its HRV designation with detailed procedural guidance in the notified law.  
2.391.   4. For Article 105, §4, al.4, it is recommended to adopt fact -based, objective and fair risk 
assessment criteria. China's concern is not about whether the notified law compl ies with the EU 
Coordinated risk assessment or the EU 5G Cybersecurity Toolbox, but about whether the risk 
assessment criteria set out in the notified law are objective and impartial. China finds that the risk 
assessment criteria are discriminatory and vag ue. For instance, the criterion as regards the extent 
of interference to the vendor by a non -EU country constitutes discrimination based upon the origin 
of vendors and discriminates the vendors from non -EU countries. China reiterates that the 5G 
equipment security shall be assessed based on facts and industry -recognized objective security 
standards instead of a non -objective risk assessment of the vendors. China urges that Belgium 
comply with Article 2.1 and 2.2 of the TBT Agreement and other WTO requiremen ts by developing 
objective, fair and non -discriminatory 5G equipment security standards and measures, taking full 
consideration of the characteristics and usage of 5G technology and adopting existing industrial good 
practices.  
2.392.   5. For Article 105, §5, it is recommended to provide so -called HRVs with rationales of the 
assessment and with reasonable remedies. The EU's reply did not address China's core concern. The 
notified law only allows 5G MNOs to defend against the preliminary res ults 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 any legal remedies. Given that it is the vendors of 5G equipment 
or services that are subject to th e risk assessment, China proposes that Belgium specify the 
administrative or judicial remedies for the vendors of 5G equipment or services in the notified law, 
requiring the competent authority to provide so -called HRVs with rationales and evidence of its 
decision, and grant vendors the right to defend themselves against unfavourable risk assessment 
decisions.  
2.393.   For the G/TBT/N/BEL/45 , we would like to raise concerns that: 1. The royal decree as well 
as relevant regulations and technical standards shall be provided and comply with the principles of 
fairness, non -discrimination, and transparency on the basis of objective facts and evidence. China 
suggests the adoption of internationally recognized technical standards that can objectively assess 
the product security or certification metho ds that are based on international standards as 
fundamental assessment criteria for product security, rather than the non -objective risk assessment 
criteria based on the characteristics of vendors. Regarding Chapter 2 of the notified royal decree, 
such Cha pter prohibits or restricts the 5G mobile network operators from using active elements 
produced by "high-risk equipment manufacturers " without specific criteria. China would like to point 
out that there are international standards based on technical criter ia 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 Com mon 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).  
2.394.   2. China suggests that Belgium could specify the admini strative or judicial remedies for 5G 
equipment manufacturers affected by the notified royal decree and relevant laws, regulations and 
technical standards. Chapter 2 of 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 provide any legal remedies for 5G equipment 
manufacturers identified as so -called HRVs, nor does it illustrate the method and procedure  to lift 
the HRV designation. China proposes that Belgium could specify the administrative or judicial 
remedies for 5G equipment manufacturers in the notified royal decree, requiring the competent 
authority to provide rationales and evidence of its decisio n and provide the 5G equipment 
manufacturers the way to defend themselves against unfavorable risk assessment decisions and 
detailed procedures to remove a high -risk designation, ensuring that the 5G equipment 
manufacturer identified as so -called HRVs is e ntitled to apply for removal of the designation. 3. The G/TBT/M/86  
 
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  royal decree and relevant laws, shall be prepared, adopted, or applied in a manner commensurate 
to the intended legitimate objectives. Furthermore, they shall not be more trade -restrictive than 
necess ary to fulfil their legitimate objectives. The notified royal decree generally prohibits the use 
of any active elements produced by "high-risk equipment manufacturer " in specific types of 
networks. China suggests that different security levels can be appli ed on the basis of product 
characteristics and objectively definable product security assessment standards.  
2.395.   In response, the representative of the European Union  provided the following statement. 
During the commenting period of those notifications, China s ubmitted written comments to which 
the EU replied on 8 November 2021. 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. More over, 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. Moreover, the EU can provide the following 
specific replies: First, all the criteria on the  basis of which a supplier's risk profile is assessed originate 
from the NIS Cooperation Group's 5G toolbox, except for the following "subfactor": "e) the country 
the supplier originates from conducts or is involved in an offensive cyber policy ". Second, t he 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 Article 105, § 4, subparagraph 4 of the adopted 
law. 
2.396.   The interpretation of the term "supplier " in Article 105, § 4, subparagraph 4, was explained 
in the latest explanatory memorandum to the adopted law. 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. 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 apply ing for a ministerial authorization), 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 adopted law and the notified draft under  
G/TBT/N/BEL/45  do not provi de 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 supplier's risk profile is assessed for each separate case. Regarding the  determination of 
the supplier's risk profile, the factor of "the likelihood of the supplier being subject to interference 
from a non -EU country " is justified and explained in the explanatory memorandum to the adopted 
law. Regarding HRVs, as indicated prev iously, 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 authorization will receive a draft decision and may make written 
observa tions and request a hearing, as foreseen in Article 105, § 5, subparagraph 2 of the adopted 
law. An appeal against the final decision of the Ministers can be lodged with the Council of State. 
The HRV is able to do initiate this appeal, since Article 19, fi rst sentence of the coordinated Acts on 
the Council of State provides this can be done by any party who gives evidence of prejudice or of an 
interest.  
2.1.3.49   India - Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 20 12, G/TBT/N/IND/44 , G/TBT/N/IND/44/Add.1 , 
G/TBT/N/IND/44/Add .2, G/TBT/N/IND/ 44/Add.3 , G/TBT/ N/IND/44/Add.4 , 
G/TBT/N/IND/44/Add.5 , G/TBT/N/IND/44/Add.9 , G/TBT/N/IND/47 , 
G/TBT/N/IND/47/Add.1 , G/TBT/N/IND/47/Add.1/Corr.1 , G/TBT/N/IND/47/Add.2 , 
G/TBT/N/IND/47/Add.3 , G/TBT/N/IND/58  (ID 367104) 
2.397.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates this opportunity to submit comments with respect to the "Electronics and IT 
Goods (Re quirement of Compulsory Registration) Order, 2012", notified to the WTO in October 2020 
as G/TBT/N/IND/44/Add.9 , and "Clarification regarding coverage of Cameras, Speakers and 
Microphones used in Automotive sector" announced in July 2021 without notification to the WTO 
Members. Korea once conveyed a letter of comments from Korean companies to India through the 
Indian TBT enquiry point on 8 September 2021. However, we have not yet received any reply from 
India, so we would like to reiterate our earlier comments as follows. As finished cameras for vehicles 
 
104 For previous stateme nts follow the thread under ID 367 . G/TBT/M/86  
 
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  were added to the subject of Electronics and IT Goods Compulsory Registration Order (CRO), which 
is implemented from 1 October 2021, our companies are having difficulties in interpreting the scope 
of application for "finish ed products". According to clause (iv.) of the Clarification note (W -
47/38/2021 -IPHW) issued by the Indian Government on 22 July 2021, finished cameras used in 
automobiles fall within the scope of CRO. Furthermore, according to "Frequently Asked Questions 
(FAQ) with respect to products notified under phase V" published online by the Indian Government 
in February 2021, it is clarified that "the Compulsory Registration Order applies only to the finished 
goods and not to the spare parts/components used in the manufacturing of the finished goods, 
unless they are notified separately as independent products under CRO".  
2.398.   In general, camera modules manufactured by Korean automotive parts companies are items 
for business -to-business (B2B) transactions that must be ins talled onto vehicles through additional 
assembly processes in India, and they are not considered as finished products. Despite recognizing 
that their products are not finished products, Korean manufacturers requested the Indian 
Government to provide a clea r interpretation of the scope of product coverage in order to faithfully 
comply with the regulation. But since no response has been received so far, the manufacturers are 
confused about whether to proceed with the follow -up procedure. If sub -parts in finis hed products 
such as camera modules are included under the CRO's scope, follow -up procedures such as approval 
to use the BIS mark are required, which will burden the industry with excessive cost and delay in 
export. Regarding the scope of application of th e product, Korea would like to enquire to India about 
the clear definition of "finished cameras being used in automotive", and whether the camera modules 
for business -to-business (B2B) transactions, and not finished products, fall within the scope of CRO.  
2.399.   The representative  of Canada  provided the following statement. Canada would like to 
reiterate its concerns with this measure and would welcome any further clarification and information 
that India can provide today to the Committee. Canada notes that India's unwillingness to accept 
tests performed in accredited foreign facilities is a systemic issue across a range of prod ucts. Canada 
continues to encourage India to adopt IEC standards and to recognize test results from 
internationally accredited labs. As noted in previous meetings, Canada remains concerned by the 
CRO for the following reasons: it requires product testing b e done only by Bureau of Indian 
Standards -accredited labs located within India; it does not allow for the use of international 
standards; and it does not recognize test results from other  accredited labs.  
2.400.   In response, the representative of India provided t he following statement. Digital Camera,  
Video Camera and Webcam (Finished Product) are covered under "Electronics and IT Goods 
(Requirement of Compulsory Registration) Order, 2012 (CRO) " vide Gazette Notification No. S.O. 
3429(E) dated  1 October 2020, and the Order came into effect from 1 Oct ober 2021. It is clarified 
that CRO applies only to the finished goods and not to the spare parts/components used in 
manufacturing the finished goods unless they are notified separately as independent products under 
CRO. The finished cameras used in the automotive are covered under CRO; however, if they are 
imported as an integral part of a vehicle, they would not attract CRO provisions. A clarification note 
vide W -47/38/2021 -IPHW dated 22 July 2021 is already issued by the Ministry of Electronics and 
Information Technology.  
2.1.3.50   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 585105) 
2.401.   The representative of China  provided the followi ng statement. China finds that the 
regulations on tethered unmanned aircraft systems (UAS) still constitute an obstacle to trade, so 
China would like to reiterate our concerns as follows, and hopes that the EU will actively consider 
our recommendations. 1.  It is recommended that the factor of mechanical strength for the heavier -
than-air tethered UAS cable in the EU Regulation 2019/945 should be no less than four times of the 
maximum take -off mass (MTOM) The requirement for the mechanical strength of the tet hered UAS 
cable is stricter than necessary. The regulation requires ten times by take -off weight, according to 
assessment by enterprises, four times is enough for safety. It is calculated that the safety factor of 
mechanical strength of different material cables ten times by the take -off weight is 2.8 - 8.4, which 
is much higher than the safety factor of all parts of manned civil aviation and general aviation (1.25 -
1.8). The excessive requirement also leads to a significant reduction of the overall performa nce. In 
addition, the backup batteries, automatic return and other technologies are more conducive to 
 
105 For previous statements follow the thread under ID 585 . G/TBT/M/86  
 
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  ensure the safe operation of the tethered UAS in terrible weather, air flow and other special 
conditions.  
2.402.   1. China recommends that EU change the extension  length limit of category C3 tethered 
UAS from "50 meters " to "120 meters ". We consider the limit of the length of category C3 UAS is 
too short. With the development of technology, category C3 of tethered UAS has excellent stability 
and wind resistance. Th e extension length of 50 meters required by EU regulation, could not meet 
the needs of customers and limit the development of this type of tethered UAS. Since the regulation 
limits the flying height of "Open Drones " to 120 meters, and category C3 of the te thered UAS do not 
have more risks than Open Drones, we suggest that EU consider using the same criteria for both of 
them.  
2.403.   In response, the representative of the European Union  provided the following statement. 
Commission delegated Regulation (EU) 2019/945 on unmanned aircraft systems 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. Regarding the requi rement for the mechanical strength of the tethered UAS cable is stricter 
than necessary, the factor of 10 is coming from tethered gas balloons certification specifications and 
takes into account the unmanned aircrafts accelerations, the variability of the tether material and a 
safety factor. On the extension length limit of category C3 tethered UAS, the EU considers that 50m 
is the maximum that can be authorized in the open category (low risks operations) as it represents 
the maximum altitude under which th e probability to have manned aircraft operations can be 
considered as extremely low. This limit is also consistent with the recommendations of the SORA 
risk analysis.  
2.1.3.51   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 393106) 
2.404.   The representati ve 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 meeting 
held in November last year. Australia understands that the EU is considering loweri ng existing MRLs 
for pesticides no longer approved in its jurisdiction due to environmental concerns - such as some 
neonicotinoid insecticides – to default values and refusing new requests for import tolerances for 
these products. By applying EU environmen tal 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 dietary aspects, introduces arbitrary criteria 
that are incompatible with current international practice and the EU's obligations under the SPS 
Agreement. This approach assumes the EU is better placed to assess the environmental impacts of 
active substances in third countries than the chemical regulators of those countries.  
2.405.   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 harmonized 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 profitability while looking after Australia's unique envir onment. To avoid trade disruption, it is 
imperative that the EU continues to comply with its obligations under the TBT and SPS Agreements 
when setting MRLs and considering requests for import tolerances. Australia once again requests 
that the EU respects t he 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 this approach will result in significant tra de disruptions. We remain 
available to discuss our approach to pesticide regulation with the EU and look forward to continued 
constructive engagement on this issue.  
2.406.   The representative of Brazil  provided the following statement. Brazil would like to refer t o 
its previous statements regarding STC 393. We emphasize that regulations on endocrine disruptors 
 
106 For previous statements follow the thread under ID 393 . G/TBT/M/86  
 
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  should be established according to sound scientific principles, taking all available data into 
consideration. Serious evaluations must be able to separate ch emicals that have the potential to 
cause harm due to their endocrine mode of action from those substances that do not pose a threat 
to human health. A solid risk analysis, consistent with CODEX guidelines, is important to ensure 
transparency and predictabi lity in the regulatory processes regarding plant protection products and 
LMRs. Brazil believes that the European approach to limit the use of pesticides is more trade -
restrictive than necessary to fulfill its legitimate objectives under the TBT Agreement. It also 
disregards risk analyses in the setting of regulatory measures that may have a serious impact on 
trade.  
2.407.   The representative of Canada  provided the following statement. Canada would like to take 
this opportunity to once again echo the concerns raised  by many other Members regarding the 
European Union's (EU) hazard -based regulation for active substances in plant protection products 
and the setting of import tolerances. Canada does not favour or promote the use of any one 
production method over another and we share the objective of ensuring that pesticides are used 
only as necessary. In order to achieve the correct balance for growers, as well as to ensure plant 
health and minimal waste, farmers need to have access to a wide range of effective and afford able 
plant protection products, including both chemical and biological options. We have in place an 
effective regulatory regime to monitor the safe use of chemical solutions when needed, including 
clear labelling requirements. Using integrated pest managem ent approaches, we support farmers in 
their own assessment of what is needed according to growing conditions, market demand and other 
factors. Rigorous regulatory requirements exist, including scientific assessments and monitoring 
programmes, to ensure the  health and safety of consumers where pesticide residues can be a factor, 
as well the health of the environment. We encourage the EU to take an approach which does not 
unnecessarily limit the availability of all crop protection tools for growers. Regulator y decisions based 
on assessments of both hazards and risks for all active substances are the best means to achieve 
the right balance between grower and consumer safety on one hand and food security and reduced 
waste on the other.  
2.408.   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 criteria and other 
(unspecified) considerations. Canadian growers and exporters have yet to be convinc ed 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 de termine what environmental factors will be considered and how these will be 
scientifically justified in the dietary risk assessment. Canada would also be interested in receiving 
information regarding upcoming regulatory or policy changes, including any ava ilable updates since 
the last seminar held in Brussels in January 2021, to ensure that unnecessary trade barriers are 
minimized and that measures are consistent with international trade obligations. 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 would likely be 
needed, regardl ess of the results of the hazard screen.  
2.409.   The representative of Ecuador  provided the following statement. My country shares the 
concerns raised by the Members that have already taken the floor.  Ecuador recognizes the 
importance of protecting human health an d 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 e manating from the international specialized bodies recognized by the WTO, such as the 
Codex Alimentarius, which has relevant information on pesticides.  Ecuador also urges the EU to take 
into account the recommendations of the Committee on Technical Barrier s to Trade related to good 
regulatory practices, particularly with regard to carrying out a Regulatory Impact Analysis prior to 
the issuance of regulatory proposals, which examines all possible social, economic, environmental 
and health impacts. This is to  ensure compliance with the obligation not to be more trade -restrictive 
than necessary to fulfil a legitimate objective, in accordance with Article 2.2 of the TBT Agreement.  
Lastly, my country once again calls upon the EU to ensure that, in cases where the re is a lack of 
scientific information, EFSA does not make a recommendation on the MRL, since decisions on G/TBT/M/86  
 
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  regulatory measures must be based on conclusive risk analyses that provide real health protection 
and do not constitute a technical barrier to trade.  
2.410.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and refers to its previous statements by stressing the importance of adopting a scientific 
approach to the regulation of phytosanitary products based on risk  and not just on the hazard arising 
from the intrinsic properties of a chemical.  In this regard, Paraguay once again requests that the 
European Union take into consideration information on pesticides provided by the specialized 
agencies recognized by the W TO, 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, ensure import tolerances; and, where necessary, provid e 
adequate transitional periods.  We echo the concerns and questions of the delegations of Australia 
and Canada in relation to the MRL -reduction announcements and the non -granting of import 
tolerance for certain plant protection products owing to environmen tal concerns.  
2.411.   The representative of Guatemala  provided the following statement. Guatemala remains 
concerned about the non -renewal of active substances deemed to be potential endocrine disruptors 
and the decision -making based on the precautionary principle.  The importance of the general risk 
analysis framework needs to be recognized (this  includes risk assessment, risk management and 
risk communication).  The precautionary principle is justified when potentially negative effects of an 
active substance are ide ntified, without considering the characterization of exposure related to 
product use, thus increasing scientific uncertainty.  We would like to express the importance of basing 
the assessment of active substances for the establishment of import tolerances o n risk analysis, 
particularly for developing countries with tropical climates and thus agro -ecological conditions 
different from those of the European Union.  In addition, geographical location, namely the distance 
and time needed to export a product to the  European Union, is another condition that should be 
taken into consideration to avoid applying measures that unnecessarily restrict trade.  
2.412.   The representative 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 SPS measures based on risk assessments, taking account of the risk 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.  
2.413.   The representative of Costa Rica  provided the following statement. As on previous occasions, 
Costa Rica reiterates its support for the trade concern raised by Australia, Brazil and Canada.  Costa 
Rica is concerned about the hazard -based approach adopted by the European Union, given that, 
under the multilateral system obligations, all technical requirements must be based on the relevant 
international reference standard or a risk assessment providing the scientific evidence to support 
the measure. Costa Rica r eiterates its request to the European Union to ensure that the 
implementation of its regulations is based on the use of risk assessments through the application of 
criteria supported by sufficient scientific evidence, in line with the commitments establish ed in the 
TBT Agreement.  
2.414.   The representative of Chile provided the following statement. The delegation of Chile thanks 
the European Union for the opportunity to comment on this STC and refers to the statements made 
by Chile on this subject at previous meeti ngs of the TBT Committee.  
2.415.   The representative of Colombia  provided the following statement. Colombia wishes to 
reiterate its grave concern regarding the hazard -based approach used by the European Union to 
establish regulatory measures for plant protection p roducts under which it does not approve or does 
not renew permits for marketing certain plant protection substances and modifies maximum residue 
levels. We reiterate that this type of measure needs to be based on risk assessment results and 
conclusive scie ntific evidence. We call upon the European Union to use, and base its decisions on, 
the information provided by international reference bodies such as the Codex Alimentarius. This 
enables the realities, challenges and needs of developing countries and diff erent geographical areas 
to be taken into account. We also invite the European Union to review alternative measures that are 
not more restrictive than necessary to trade, including when adopting measures to protect the 
environment and human health.  G/TBT/M/86  
 
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  2.416.   The re presentative 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 based on fu ll 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 Regulation 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 systems, bei ng withdrawn despite their safe use. This is due to the fact that an 
approach based on hazard rather than on actual risk could have a negative and disproportionate 
impact on production, while contributing little or nothing to the cited aim of protecting pu blic health.  
Like other Members, we would like to be given further details on the way in which the 
European  Union plans to take environmental effects into account when assessing tolerance requests 
for active substances no longer approved in its territory, taking into account the provisions of the 
SPS Agreement.  Uruguay continues to support any multilateral work undertaken by the Codex 
Alimentarius to develop a harmonized, risk -based approach that ensures the protection of health, 
while facilitating internat ional trade in food products. In the meantime, we once again call on the 
European Union to listen to and address the concerns expressed by a number of Members, and to 
reconsider its regulatory approach with a view to preventing the unjustified proliferatio n of barriers 
to international trade in agricultural products and the serious social and economic consequences of 
such an approach for other Members, in particular developing and least developed countries, for 
which the European  Union is a key market.  
2.417.   In response, the representative of the European Union  provided the following statement. 
The European Union thanks WTO Members for their interest in the ongoing work in the EU on 
identifying endocrine disruptors for plant protection products. The EU reiterates that the scientific 
criteria to identify endocrine disruptors for plant protection products based on the WHO definition 
are applicable since 10 November 2018 onwards and included in Regulation (EU) No 2018/605. We 
are aware of general concerns on EU policy  on plant protection products for the definition of scientific 
criteria to identify endocrine disruptors and on the establishment of import tolerances for substances 
not authorised in the EU, due to the so -called "cut-off" criteria in Regulation (EC) No 11 07/2009. As 
previously explained, the European Union decided to follow the procedures of Regulation (EC) No 
396/2005 for the management of import tolerance requests concerning active substances falling 
under these cut -off criteria, which include a risk ass essment 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 al l relevant factors.  
2.418.   The EU will take into account environmental aspects when deciding about requests for import 
tolerances for substances no longer approved in the EU, while respecting WTO standards and other 
international obligations. Such environmental i ssues of global concern are, for example, the 
worldwide decline of pollinators, or the contamination of the environment with bioaccumulative, toxic 
and persistent chemicals. The European Union intends to address this matter on an incremental 
basis, conside ring and reviewing the position of each particular active substance on a case -by-case 
basis, founded on the best available scientific evidence and ensuring that its measures are not more 
trade restrictive than necessary to achieve their objective. It is im portant to note that this new 
approach will not prohibit other countries to use the pesticide on the crop, as other countries are 
free to decide on the use of pesticides on their territory. If the harvested crop is destined to be 
placed on the EU market, i t must comply with the Maximum Residue Levels (MRLs) in place in the 
EU. In addition, applicants have the possibility of submitting additional information to prove that the 
good agricultural practices included in import tolerance request is sufficiently pr otective for the 
environment. The EU would like to draw the attention of the TBT Committee to the thematic session 
on Trade Facilitative Approaches to Pesticide MRLs, which will take place at the margins of the next 
SPS Committee meeting on 22 March 2022 a nd provide further opportunities to discuss this topic. 
The EU reiterates its commitment to act in full transparency and keep Members duly informed about 
further developments.  G/TBT/M/86  
 
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  2.1.3.52   Brazil - Draft Ordinance Act Nº. 374, 27 November 2014 (Portaria SDA/MAPA 
374/20 14) Establishes quality requirements for wine and derivatives of grape and wine, 
G/TBT/N/BRA/613 , G/TBT/N/BRA/613/Add.1 , G/TBT/N/BRA/613/Add.2 , 
G/TBT/N/BRA/613/Rev.1 , G/TBT/N/BRA/675 , G/TBT/N/BRA/613/Add.3  (ID 470107) 
2.419.   The representative of the European Union  provided the following statement. The European 
Union would like to thank Brazil for notifying the draft Te chnical 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 2022. The European Union appreciates the recent 
reply of Brazil announcing a pub lic audience that will provide for further opportunity to review the 
amended draft regulation. The EU would like to ask about the estimated date for the public audience, 
when the revised draft regulation will be published and whether Brazil will notify the  revised text to 
the WTO TBT Committee. The European Union would like to recall its main general concerns and 
refer 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 parameters are consistent with OIV recommendations. Second, the EU would like to invite 
Brazil to aim at resolving in the ongoing revision the longs tanding 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 TB T Committees, the European Union would like to encourage Brazil to seek international 
consensus within the OIV framework 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 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 Unio n 
is prepared to work bilaterally with Brazil with regard to the ongoing revision, invites Brazil to take 
into account the EU written comments and looks forward to the opportunity to review the revised 
draft regulation.  
2.420.   In response, the representative 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 
regard ing 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 comm ents until 7 
December, what has been notified as G/TBT/N/BRA/613/ Add.3 . Brazil appreciates the comments 
received from the EU and from the US on this notification, which are important to improve the 
regulation of wine, grapes and their products in Brazil.  
2.1.3.53   United Kingdom - Wine labelling and documentation requirements at the end of 
the Brexit transition period (ID 663108) 
2.421.   The representative of Australia  provided the following statement. Australia appreciates the 
engagement with the United Kingdom in this Committee and welcomes the steps taken by the UK 
Government to remove burdensome requirements such as those for VI -1 forms for all wine imports 
into Great Britain. However, Australia continues to have concerns over labelling requirements, 
particularly as they relate to wine exported and transhipped through the UK to the EU. We 
acknowledge the United Kingdom's response in the previous Committee meeting - that wine 
marketed in Great Britain can show either a United Kingdom or a European Union imported on the 
label until 1 October 2022 and that after that date, wine products mar keted in Great Britain must 
bear the details of an importer situated in Great Britain on the label of products. As was raised in 
the previous meeting, we are seeking flexibility to allow the listing of multiple importers on the label 
of wine bottles import ed into the UK and for multiple destinations, particularly after that grace period 
ends. We believe it is possible to include a UK importer and importers in other third countries and 
 
107 For previous statements follow the thread under ID 470 . 
108 For previous statements follow the thread under ID 663 . G/TBT/M/86  
 
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  still meet regulatory objectives; for example: "For the UK, imported by.. ." and "For the EU, imported 
by...". We would like the UK to please clarify whether it would accept labels with a UK and EU 
importer on the label after 1 October 2022, as this would mean the label still bears the details of an 
importer situated in Great Br itain We want the UK to ensure any labelling requirements are no more 
trade restrictive than necessary to achieve their objectives and look forward to working closely with 
the UK on this issue to ensure a mutually satisfactory outcome. Australia welcomes t he bilateral 
engagement we have had to date. We look forward to addressing these issues further in upcoming 
bilateral engagement, given they remain a major concern for our wine industry.  
2.422.   The representative of Uruguay  provided the following statement. First, my delegation 
welcomes the adoption of legislation to lift the requirement to submit VI -1 forms for the importation 
of wine into Britain.  Second, Uruguay once again wishes to express its interest in remaining informed 
of the regulatory requirements and c onditions that will apply to the importation of wine into the 
United Kingdom market from 1  October  2022, in particular with respect to documentation and 
labelling, and in ensuring that such requirements are the least trade -restrictive possible.  
2.423.   In response , the representative of the United Kingdom  provided the following statement. 
The United Kingdom welcomes Australia's and Uruguay's continued interest in our wine labelling 
requirements, and the constructive bilateral engagement we have had with Australia o n this topic. 
As we have said in previous statements on this matter in February, June, and November 2021, for 
wine imported into Great Britain, our regulations allow for an importer situated in either the 
European Union or Great Britain to be shown on the label of wine products marketed in Great Britain 
until 1 October 2022. After that date, the label of wine products marketed in Great Britain must bear 
the details of an importer situated in Great Britain. We reiterate that we designed the transitional 
arrangements in close cooperation with the wine industry to minimise the impact on trade as a result 
of the UK leaving the EU, whilst also taking into account our policy objectives on consumer 
protection. We take note of Australia's suggestion of allowing indi vidual wine labels to show details 
of two importers to facilitate sales in different international markets. However, at the moment our 
rules do not permit this. Rules in this area are complex, falling under both wine and horizontal food 
labelling laws. The y do share the unified aim of protecting the interests of the consumer, providing 
a clear point of contact should a problem be detected with the wine, and to ensure that information 
on the label is relevant to the product being offered for sale and is not misleading or confusing for 
the consumer. The UK Government is in the process of gathering broad evidence from stakeholders 
on whether the current rules could be refined to further benefit wine producers, traders and the 
interests and wellbeing of consumer s. Wine labelling rules are an area that is under consideration. 
We remain available for further bilateral discussions with Australia and Uruguay to discuss our 
regulatory approach. Further details of the wine labelling measures that apply are available on  the 
UK Government website.109 
2.1.3.54   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 659110) 
2.424.   The representative of Australia  provided the following statement. Australia thanks the EU for 
their engagement to date on  this important issue. We nevertheless note this issue remains an 
ongoing concern and a barrier for industry that relied on shipments between the United Kingdom 
and the European Union prior to the UK's departure from the EU. We understand that, following t he 
end of the Brexit transition period, the UK has rolled over existing EU wine laws and regulations, 
meaning wine imported and sold in the UK requires the name and address of a UK -based importer 
on the label. We understand the same requirement applies to bottled wine sold in the EU. As wine 
is regularly exported to the EU through the UK, it would be logical to give details of both EU and UK 
importers on a single label to ensure trade can continue uninterrupted and without additional 
expense to wine produce rs. Under EU regulations, we understand that an indication of the "importer" 
is compulsory for wine imported into the EU (under Regulation No. 1308/2013 and Delegated 
Regulation 2019/33), to identify the natural or legal person or group of persons importin g the wine 
into the EU. We are supportive of the EU's objective of clearly identifying the business food operator, 
for example the person assuming responsibility for bringing the wine into circulation in the EU, and 
not misleading consumers. However, we as k the EU to provide assurance that its labelling 
requirements are no more trade restrictive than necessary to achieve their objectives.  
 
109 https://www.gov.uk/guidance/importing -and-exporting -wine. 
110 For previous statements follow the thread under ID 659 . G/TBT/M/86  
 
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  2.425.   We have stated in previous committees and maintain that the EU allowing an "optional 
particular" on labels to cover impo rters in other third countries would be consistent with the EU's 
objectives, while still clearly identifying the EU importer and person assuming responsibility. For 
example: statements such as "For the EU, imported by..." and "For the UK, imported by..." w ould 
not mislead consumers as regards the business food operator. Australia seeks to understand how 
the requirements that do not allow this, described by the EU in the last committee meeting, are not 
unnecessarily trade restrictive. As we raised in the pre vious Committee meeting, we are also seeking 
clarity from the EU on whether it is possible to list importers for multiple destinations on the same 
wine bottle label under current EU Regulations. Further guidance and clarity are important to provide 
certain ty to traders and ensure no interruptions to trade occur. We look forward to working closely 
with the EU on this issue to ensure a mutually satisfactory outcome as we continue similar 
discussions with the UK to resolve this issue for wine imported into the  UK. 
2.426.   In response, the representative of the European Union  provided the following statement. As 
explained in previous TBT Committees, the indication of the "importer" is a compulsory indication 
for wine imported into the EU in accordance with Regulation (E U) No 1308/2013111 establishing a 
common organization of the markets in agricultural products and Delegated Regulation (EU) No 
2019/33.112 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 952/2013113 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 only be 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 assumin g responsibility for bringing the wine 
into circulation in the EU). The EU reiterates that it is not possible to list "importers " for multiple 
destinations on the same wine bottle label.  
2.1.3.55   United Arab Emirates - Requirement of G -mark for every toy (ID 702114) 
2.427.   The representative 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. And it 
can be issued only by the agencies authorised by the GCC Standardisation Organisation. This 
requirement of G -mark makes Indian products uncompetitive in the UAE as no agency is authorised 
to issue G -mark in India. To get G -mark certified products, Indian exporters have to send the entire 
consignment to the place where it can be G -mark certified. 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 the 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 repre sentative item. Despite the latest GSO 
guidance specifying test reports are required 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 t he 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 strict er 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. Hence the UAE is requested  to consider that when the G mark is obtained for each 
and every toy, then the physical sampling should not be insisted by the Notified Bodies for all the 
 
111 Regulation (EU) No 1308/2013 of the European Parliame nt and of the Council of 17 December 2013 
establishing a common organisation of the markets in agricultural products 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. 
112 Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) 
No 1308/2013 of the European Parliament and of the Council as regards applications for protection of 
designations of origin, geographical indications and tradit ional 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.  
113 Regulation (EU) No 952/2013 of the European Parliamen t and of the Council of 9 October 2013 
laying down the Union Customs Code, OJ L 269, 10.10.2013, p. 1.  
114 For previous statements follow the thread under ID 702 . G/TBT/M/86  
 
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  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.  
2.428.   The representative of the United Arab Emirates  did not provide a response to the concerns 
raised.  
2.1.3.56   Colombia – Good manufacturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 697115) 
2.429.   The representative of the European Union  provided the following statement. The European 
Union would like to thank Colombia for its reply of November 2020 to the EU written comm ents and 
for the extensive bilateral discussions and hopes that the Decree no 162 published on 16 February 
2021 will not create unnecessary burdensome requirements for EU exporters of wines and spirits. 
The European Union notes that Article 3 of the adopte d decree refers to the possibility to present 
alternatives 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 sa nitary 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 Stat es would comply with the 
Colombian requirement to provide Good Manufacturing Practices certificate upon import. The 
European Union would, therefore, like to ask Colombia to confirm this interpretation. With less than 
a year time left for the entry into for ce of these requirements, the European Union is increasingly 
concerned about the impact this measure could have on its exports, especially from SMEs, should 
not all its Free Sale Certificates be accepted. Therefore, the European Union is prepared to contin ue 
the bilateral work should there be any need for additional clarifications.  
2.430.   In response, the representative of Colombia  provided the following statement. First of all, 
we would like to highlight the important work that has been carried out jointly by the  health 
authorities of Colombia and the European Union to clarify various concerns regarding compliance 
with Ministry of Health Decree No. 162 of 2021. These discussions have focused mainly on the 
acceptance of certificates of good manufacturing practices (GMP), thus responding to the concerns 
raised regarding the acceptance of certificates of free sale issued by the European Union authorities. 
The text issued ensures equal conditions regarding the GMP certificate for domestic producers and 
producers locate d outside the national territory, and provides four alternatives for complying with 
the technical regulation. For the requirement in the case of imported alcoholic beverages, these four 
feasible options do not disregard the regulations of the country of or igin of the parties concerned, 
meaning that such parties can assess each of the options and apply one of them in order to comply 
with the Colombian regulations. The health authorities have reiterated that certificates of free sale 
may be included in option  C of the above -mentioned Decree, provided that they comply with the 
provisions thereof, namely: (i) they are issued by the competent authority, by the accredited 
certification body or by the authorized third party in the country of origin of the product, and; (ii) 
they state that the alcoholic beverage and the producer comply with technical control and inspection 
standards, processes or procedures. Furthermore, Colombia recalls that the deadline for 
implementing the provisions regarding the requirements fo r good manufacturing practices is 14 
February 2023. The relevant authorities have reviewed the documents provided by the European 
Union and have expressed their willingness to continue working together to resolve the concerns 
raised and to find common grou nd to ensure compliance with this technical regulation. We reiterate 
our interest in continuing the bilateral work that has been taking place with our health authorities.  A 
technical statement was circulated following the meeting.116 
2.1.3.57   Argentina - Requirement of affidavit along with the product certification from a 
certified body for export of boards derived from wood (ID 696117) 
2.431.   The representative 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 product 
certification from a certified body for the export of boards derived from wood. India thanks Argentina 
for its notification G/TBT/N/ARG/342/Add.6  dated 22 February 2021 on the proposed draft 
 
115 For prev ious statements follow the thread under ID 697 . 
116 G/TBT/W/767 . 
117 For previous statemen ts follow the thread under ID 696 . G/TBT/M/86  
 
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  Resolution "Technical quality and safety requirements applicable to boards derived from wood". As 
per Article 2 of the Draft Resolution, besides product certification, an a ffidavit from a certified body 
indicating compliance to the requirements is required. India has submitted its queries to Argentina's 
Enquiry Point seeking relevance of an affidavit indicating a product's compliance, mainly when a 
certification requirement is already in place. India believes that the additional requirement of an 
affidavit will add both to the cost and procedural burden for exporters, thereby adversely affecting 
the product's competitiveness in Argentina. Further, no risk assessment for the a dditional 
requirement of an affidavit is shared by Argentina. Hence, prima facie Argentina's requirement of 
an affidavit in addition to certification requirement appears to be trade restrictive.  
2.432.   It is also not known what other less trade -restrictive or alt ernative measures Argentina 
considered before deciding on the present measure. Given the above, Argentina is requested to not 
to impose the additional affidavit requirements; and please, respond to the queries submitted by 
India to its Enquiry Point.  
2.433.   In re sponse, the representative of Argentina  provided the following statement. SCI 
Resolution No.240/2019 and the amendment thereto, SCI Resolution No.  428/2021, establish three 
distinct and non -overlapping stages for the fulfilment of technical requirements.  In the first stage, 
an affidavit must be submitted, alongside test reports. In the second stage, proof of initiation of the 
certification process is needed. In the third stage, a certificate issued by a certification body is 
required.  Argentina understands that India's interpretation is confused or mistaken, as the two 
stages do not overlap. In other words, the affidavit stage ends once the certification stage takes 
effect.  It should be noted that the "Proof of initiation of the certification process" and "C ertification" 
stages are contingent on recognition by a certifying body and the issuance of an administrative act 
by the National Technical Regulation Directorate, following which these stages would become 
effective.  In addition, it should be noted that th e Argentine Focal Point has no record of the comment 
submitted by India, and we therefore request that it be resent.  
2.1.3.58   Guatemala - Technical Standard 84 -2021 for the Sanitary Registration of 
Repellent Products for External Use in Humans and Spatial Repellent  Products (ID 721118) 
2.434.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to Technical Standard 84 - Sanitary Registration of Repellent Products for External Use in 
Humans and Spatial Repellent Products, the final version of which was published on 28  August  2021 
on the website of the Department for the Regulation and Control of Pharmaceutical and Related 
Products of the Directorate -General of Health Regulation, Surveillance and Control at the Ministry of 
Public  Health and Social Welfare, and of which the Members of this Committee were not notified, 
overlooking the commitments to transparency in the TBT Agreement.  Through this space, we would 
like to reiterate the concern shared in this forum in November  2021 about to xicity studies for the 
sanitary registration of repellent products for external use in humans and the need to clarify whether 
it is possible to use existing or bridging toxicological studies on the formulations, with the aim of 
reducing the number of studi es to be carried out and the costs for importers during the corresponding 
registration application process.  Moreover, we reiterate our request for information on the technical 
and scientific evidence used to develop this technical regulation, particularly any toxicity studies 
using animal testing. This is without overlooking how important it is for the Government of 
Guatemala to observe its transparency commitments, specifically the need for this regulation to 
undergo a public consultation process, in which  the participation of interested third parties is allowed, 
prior to determining its entry into force.  Following the last meeting of this Committee, which took 
place in November  2021, the delegation of Guatemala stated that it would share the concerns 
expre ssed by the delegation of Mexico with the competent authority. We would therefore be grateful 
for any update it could share with us on this issue.  The delegation of Mexico thanks the delegation 
of Guatemala for giving its consideration to this statement an d reiterates its availability to hold 
bilateral meetings that allow the concerns expressed to be addressed.  
2.435.   In response, the representative of Guatemala  provided the following statement. In this 
regard, we have been advised that version 1 of this Technical  Standard, as identified by the Ministry 
of Public Health and Social Welfare, was developed due to the need to regulate the marketing of 
repellents of natural origin, given the health risk that may arise from their inappropriate spatial use, 
which were not  regulated in Guatemala, as evidenced in the purpose and scope of the Standard 
itself, and which Mexico has surely observed.  Guatemala has thus acted in accordance with its Health 
 
118 For previous statements follow the thread under ID 721 . G/TBT/M/86  
 
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  Code (approved by Decree No. 90 -97 of the Congress of the Republic of Guatem ala), which indicates 
that repellents comply with the classification of pesticides for domestic use and not with the 
classification of cosmetics. A product of this nature, if not applied as a repellent, is therefore 
registered as a pesticide for domestic u se, for which other Central American regional regulations 
exist.  Lastly, Guatemala takes note of the reiteration by the delegation of Mexico.  
2.1.3.59   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the label ling of pre -packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9  (ID 608119) 
2.436.   The representative of Costa Rica  provided the following statement. Costa Rica maintains its 
trade concern regarding Mexico's proposed front -of-pack nutrition labelling for food product s. In 
recent years, Costa Rica has very much believed in, and defended, the importance of the work 
carried out within the Codex Alimentarius framework, and has given equal importance to scientific 
justification for the measures adopted by each country, whether they are based on the Codex itself 
or on other technical or scientific evidence, as required by the Agreement on Technical Barriers to 
Trade. Given that the Codex Alimentarius is currently developing working materials on front -of-pack 
nutrition labelling, Costa Rica wishes to request once again that the Mexican delegation clarify its 
position regarding the work carried out in the Codex in this area.  Costa Rica would like to reiterate 
the request made to the Mexican delegation at this Commit tee's previous meetings, to indicate the 
scientific basis or international reference standard used to define the key parameters of the standard 
in question, and to provide relevant justification for the use of the front -of-pack warning sign as 
supplementar y nutrition information, the scientific basis for setting classification parameters, 
according to which a product is considered to contain excessive calories, sugar, saturated fats, trans 
fats or sodium, given that they are not Codex -based.  
2.437.   Turning to the consumption by children of products containing added caffeine or sugar 
substitutes, Costa Rica requests the delegation of Mexico to refer to either the international reference 
standard used or the risk analysis establishing the risk posed to children by th e consumption of 
products containing these ingredients.  Costa Rica believes that the measure adopted by Mexico could 
generate inconsistencies with TBT  Agreement obligations, in particular those established in Articles 
2.2 and 2.4 . Costa Rica maintains its view in this Committee that, as things currently stand worldwide 
in light of the COVID -19 pandemic, the implementation of certain sanitary and phytosanitary 
measures that create additional restrictions or burdens, constitutes a challenge that hampers globa l 
economic recovery efforts, especially in developing countries that are reliant on international trade, 
such as Costa Rica. This is without prejudice to the power that Members have to adopt them if 
considered necessary.  Costa Rica would be grateful if the  Mexican delegation could provide 
information about the status of this draft Amendment.  
2.438.   The representative of Guatemala  provided the following statement. We recognize Mexico's 
right to protect people's health and to provide consumers with information on th e food they buy. We 
thank Mexico for the response provided at past meetings. However, Guatemala would like to ask 
whether the Government of Mexico will issue a supplementary regulation and a clarification on the 
entry into force planned for April 2021, and  whether the use of supplementary labels on front -of-
pack labelling is expressly excluded.  We recall that CODEX CXS 1 -1985, General Standard for the 
Labelling of Prepackaged Foods, authorizes the use of a supplementary label which fully and 
accurately refl ects the information contained on the original label.  
2.439.   In response, the representative of Mexico  provided the following statement. Given that the 
concern was raised two days ago, we do not currently have any detailed responses; however, we 
take note of thei r concerns and we will respond shortly.  
2.1.3.60   Colombia - Food Prioritized for its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1  (ID 609120) 
2.440.   The representative of Costa Rica  provided the following statement. First of all, we would like 
to thank the delegation of Colo mbia and its capital -based authorities for the constructive meeting 
and exchange we have had over the last two days to reach a consensus on this issue.  However, we 
wish to reiterate our concern regarding the proposed Colombian Technical Regulation establis hing 
 
119 For previous statements follow the thread under ID 608 . 
120 For previous stateme nts follow the thread under ID 609 . G/TBT/M/86  
 
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  the maximum sodium content for a prioritized list of a broad range of foods, such as tuna, chicken 
sausages, chorizo, salted biscuits, ham, peanuts, butter, mayonnaise, breads, pastas, wheat flour 
products, cream cheese, soups, sauces and sausages.  Costa Rica firmly believes in implementing 
strategies aimed at protecting public health by reducing the underlying factors of arterial 
hypertension and related non -communicable diseases.  However, the proposed maximum sodium 
levels for the selected products a re not substantiated by scientific evidence. Costa Rica also does 
not consider them to be based on the international reference standards established under the Codex 
Alimentarius.  We call on Colombia to continue an open dialogue and share with Costa Rica th e 
scientific basis and risk assessment supporting the sodium levels established for each product, so 
as to facilitate our analysis of the legislation, as well as the status of this regulation and the potential 
date of its entry into force.  We reiterate our  thanks to the delegation of Colombia and we hope to 
keep channels for dialogue open for these purposes.  
2.441.   The representative of Guatemala  provided the following statement. 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 Governm ent 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 th is certificate 
of 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.  
2.442.   In response, the representative of Colombia  provided the following statement. My delegation 
will merely make some preliminary points given that this concern was not previously included on the 
agenda, and we ask the delegations of Costa Rica and Guatemala to please send us their statements. 
We would simply like t o mention that we have taken note of the concerns raised. We must point out 
to the delegation of Costa Rica that bilateral dialogue is taking place between the relevant authorities 
and that we send supporting documentation and all relevant explanatory docu ments to these 
authorities. We also wish to point out to Costa Rica that this regulation has already been adopted 
and that our Ministry of Health will contact them regarding the questions they sent us recently.  
2.1.4   Reported progress on STCs  
2.443.   The United States  highlight ed a recent positive development with respect to Mexico's 
notification G/TBT/N/MEX/496 , the Federal  Telecommunications Institute Amendments to the 
Conformity Assessment Procedure on Telecommunications and Broadcasting.  The US thanked 
Mexico for its collaboration to resolve the concerns raised by the United States and US industry 
stakeholders. Mexico had  notified the draft measure in April 2021 which aimed to amend the 
conformity assessment procedure on telecommunications and broadcasting. Following its 
notification, the United States and Mexico held several bilateral discussions on the margins of the 
TBT Committee and on 27 December 2021 Mexico published in the Official Gazette IFT's modified 
conformity assessment procedure for the field of telecommunications and broadcasting. After 
reviewing the latest publication and consulting with industry, the US was  pleased to express its 
appreciation and share its support for the modification made to the procedure. It was the US' 
understanding that the latest iteration addressed all of the concerns discussed in previous bilateral 
meetings with Mexico. The United Sta tes believed that the bilateral discussions which helped lead to 
these positive procedural developments showcased the importance of open dialogue and of such 
meetings. The US thanked Mexico again for its willingness to engage on this topic and from making 
the changes to procedure, ensuring that trade between their nations was not disrupted.  
2.2  Exchange of Experiences  
2.2.1   Transparency  
2.2.1.1   Chair's report on Informal Meeting (10 February)  
2.444.   The Chairperson  reported on the Committee's informal meeting held on 10 February. At that 
meeting, she said, she had sought Members' views on how the Committee could organize its work 
to most effectively address and deliver on the long list of transparency -related recommendations 
from the Ninth Triennial Review. She noted that the natur e of some of these recommendations was G/TBT/M/86  
 
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  such that they might require more frequent and/or ongoing dialogue and collaboration among 
interested delegations. Various Members had come forward with concrete suggestions on the general 
organization of work and on how to advance on specific recommendations  (see, for example, 
G/TBT/W/763  form the United States). A number of delegations had suggested that the technical 
elements of some of the recommendations could first be addressed by a virtual or hybrid working 
group open to all delegations and then  be brought forward for the Committee's consideration.   
2.445.   In light of this initial exchange among delegations and the strong interest to advance on the 
recommendations, she had  invited delegations to a follow -up meeting to flesh out how the 
Committee could b est organize such a working group. This meeting had been  held on 1 March over 
Zoom. In terms of the format of the working group, there was general agreement that it should be 
an open, transparent and inclusive group ; it could meet in virtual or hybrid form at, allowing relevant 
officials from capitals to participate. The deliberations and any suggestions from the working group 
would then be reported to the Committee for further consideration and follow up action , as 
necessary. In terms of how to address some  of the specific recommendations, it had been suggested 
that there could be a step -by-step approach. In some cases, a sub -group of volunteers could 
undertake some preparatory work and then bring it forward for discussion in the working group. In 
other case s, the work could start by undertaking a survey on particular practices , or by considering 
a compilation of existing materials prepared the Secretariat. In terms of specific topics, delegations 
mentioned the revision of formats ; the use of HS codes ; timing of notifications and the use of ePing 
for following up on notifications.   
2.446.   The Chairperson  noted that there was support for holding a first meeting of the working 
group towards the end of March (or early April) and that work could start on two speci fic issues: 
notification formats and use of HS Codes in notifications. To kickstart the discussions, the Secretariat 
would  provid e an overview of existing formats and would  also provide some information on product 
coverage in notifications.  The Chairperson  encourage delegations to participate in the working group 
and to volunteer to take forward specific topics.  
2.447.   The representative of the United Kingdom  supported the Secretariat's efforts to improve the 
functioning of the TBT Committee and the implementatio n of the TBT Agreement. She reiterated her 
delegation's suggestion, presented at the informal meeting on 10 February , and welcome d further 
collaboration and work on improving transparency within the TBT Committee.  
2.448.   The representative of Canada  stressed the  importance that her delegation attributed to 
transparency. Canada was  particularly interested in the efforts aimed at improving the information 
available on measures that were being notified – or that were available in a language – other  than 
French, Engl ish or Spanish . In this context, Canada noted in particular the recommendations 6.29. 
d. ii. as well as 6.29. e. i. and 6.29. e. ii. (3 recommendations) which Canada  believe d could also be 
clustered into one package of recommendations to be dealt with together. Canada  thank ed the 
United States for their paper  and noted that the US  had suggested to have a cluster of issues dealing 
with notification formats , which was useful. There were also other  recommendation s dealing with 
"developing a translation softwar e and use of other tools" in th is respect that could be consider ed. 
Canada welcomed further work in the Working Group, or even smaller sub-group settings , with the 
Chair and the Secretariat and other Members to advance on the recommendations.  
2.449.   The representative of the European Union  thanked the Chairperson for the report on the 
informal meeting of 10 February, and the Secretariat for the continuous work on the integration and 
upgrade of the onli ne tools. The European Union  underline d the centrality of transparency for the 
Committee.  The numerous recommendations in this regard made by the Members during the 
Triennial Review confirm ed its importance. The EU reaffirmed its  commitment to proceed with  
dedicated work on transparency, including dedicated subgroups , as this was likely to improve 
efficiency and progress. The EU intended to come forward with some further elements by writing in 
due course and remained available to engage with other Members.  
2.450.   The representative of Singapore  noted that her delegation had, on several  occasions , 
expressed support for the transparency initiatives and emphasize d the importance of transparency 
and notifications in the TBT  Committee . Singapore was supportive of the d iscussions that the 
Committee had at the informal meeting , including the idea of the creation of a working group, or 
even sub -groups to advance on specific work; Singapore would actively participat e in such work.  G/TBT/M/86  
 
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  2.451.   The representative of Australia  supported t he points made by other Members on the 
importance of transparency for the TBT Committee , and the WTO more broadly . Australia 
commended the work of the Secretariat on improving transparency  as this underpin ned the 
operation of the rules -based trading system . Recent efforts regarding the release of a  beta version 
of the notification portal  was a good example .  
2.452.   The representative of Switzerland  express ed support for initiatives increasing transparency 
and the establishment of sub -groups and working groups on s pecific topics related to transparency. 
He commended the integration of the existing online tools ; Switzerland was supportive of these 
initiatives – they contributed to the goals of the TBT Committee, including the implementation of 
core principles and pro cedures under the TBT Agreement . The tools enabled Members to engage  
with each other in an effective way. Regarding the recommendation on the handling of comments, 
and the sharing of comments on replies from notifications, Switzerland was pleased to see that an 
increasing number of Members had started to use the online tools to share information related to 
comments  and replies. Switzerland remained open to further engagement on these topics.  
2.453.   The Chairperson  said she would follow -up shortly  with a Communication on next steps.121 
2.2.1.2   Integration and update of online tools  
2.454.   The Secretariat  said that the objective with the integration of online tools ( the TBT and SPS 
Information Management Systems, TBT and SPS Notification Submission Systems and ePin g) was 
to improve the services on offer to Members and to strive towards a single -window platform to assist 
delegations  in their engagement with the WTO on TBT (and SPS) matters. At the same time, the 
Secretariat was keen to ensure that the new platform co ntinue to serve all stakeholders involved, 
including the private sector, and facilitate dialogue among them. This effort was also in line with one 
of the 9th Triennial Review Recommendations on transparency calling on the Secretariat to work 
towards a cent ralized platform.  The Secretariat reported that the new platform would go live on 
28 March , it is currently available here122. 
2.455.   The representative of the United States  thank ed the Secretariat and the team in the Central 
Registry of Notifications  (CRN) at the WTO  for its hard work over the last several months in 
consolidating the many online tools for TBT followers into the pilot ePing platform. The United States  
appreciate d the updates shared with Members regarding the development of the consolidated 
system , as well as the opportunity to tes t, provide feedback and observations on the ePing pilot 
platform. The USA TBT Enquiry Point staff, other US Government stakeholders and some  of the US  
most actively  engaged  private sector stakeholders explored the pilot version of the new ePing 
platform during the testing phase. The US delegations  then summarized the feedback received by 
type of stakeholder, government, private sector and shar ed it with Secretariat colleagues. The US  
had also shared feedback on TBT features with  SPS colleagues for awareness and for coordination 
purposes. When the US  noticed a few glitches in the new pilot during testing, the US delegation had  
informed the Secre tariat resulting in quickly acknowledg ment and remedi es, where possible. The 
new Notification Submission System , like the current TBT NSS , was user-friendly and intuitive. The 
interphase for searching notifications was very different from the previous one so it would  take some 
time for stakeholders to familiarize themselves with this. However , the US  had no doubt that the US 
delegations and its Notification Authority would adapt, and the US appreciate d the benefits from the 
enhancements available in the new  ePing platform , especially as the WTO adjust ed the system based 
on the feedback shared with delegations testing the system.  
2.456.   The representative of the United States also informed the Committee that the US delegation 
had begun using the current ePing systems so that other Members  would  know when the US had  
provided comments on another Member 's notification made to the TBT Committee. This was practice 
that the US had now incorporate d into its inter-agency procedures.  
2.2.1.3   Covid -19-related Notifications  (Update)  
2.457.   The Secretariat  provided an update on new COVID -19 related notifications  submitted to the 
TBT Committe e. Since the beginning of the pandemic (in March 2020), WTO Members ha d submitted 
a total of 192 COVID -19 related TBT notifications (this represent ed more than 40% of all 
 
121 The communication was subsequently circulated as ICN/TBT/11 . 
122 https://epingalert.org/   G/TBT/M/86  
 
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  COVID -related WTO notifications to date). During 2021, more than 70 notifications related to 
COVID -19 had been  submitted by Members, mostly during the months of March, April and May. 
Since the last TBT Committee meeting, between 10 November 2021 and 9 March 2022, a total of 
11 COVID -19 related TBT notifications had been  submitted. These were submitted by Brazil, Canada, 
Colombi a, Ecuador, Japan, Kenya, the Philippines, and Chinese Taipei.  The notifications cover ed a 
range of products, including COVID -19 antigen test kits and other in -vitro diagnostics, human 
immunoglobulin, UV Radiation -emitting and Ozone -generating medical devi ces, vaccines, and 
flocked swabs.  The notified measures broadly related to emergency authorization and other 
conformity assessment procedures to streamline access to medical goods, new regulatory 
requirements for medical goods, as well as other regulatory flexibilities adopted due to the pandemic.  
2.2.1.4   Article 15:2 - Statements from Members  
2.458.   The Chairperson  noted that the TBT Committee's 2021 Annual Review, circulated on 2 March 
2022 in document G/TBT/47 , contains, amongst other information, details on Members' statements 
of implementation. This inform ation is also available through the TBT IMS. The Committee  took note.  
2.2.2   Conformity Assessment Procedures  
2.459.   The Chairperson  referred to the Elements Paper circulated in document JOB/TBT/438  
(31 January 2022) and th e discussion that took place at the 10 February 2022 informal meeting of 
the Committee. At that meeting, Members had been of the view that the paper was a good basis for 
the Committee's further work to develop non -prescriptive practical guidelines for conf ormity 
assessment procedures (hereafter "the Guidelines").123 At that point, some Members had provided 
specific comments. The floor was opened for a discussion of the comments received to date and any 
other interventions Members wished to make.  
2.460.   The represe ntative of the United Kingdom  (JOB/TBT/440 ) noted, in general, that the 
Elements Paper provided a very helpful basis for work. Where possible, however, the paper could 
have stronger wording. For example, it was suggested that the word "requesting" should be replaced 
by "requiring" in para.  3.8 of the Elements Paper (see JOB/TBT/440 , p.2, for more detail). The UK 
also suggested some minor adjustments to the international standards and accreditation section, 
which were mainly about clarity and perception. The UK remained flexible and willing to discuss the 
proposed changes wi th other Members.  
2.461.   The representative of Australia  (JOB/TBT/442 ) said that the Elements Paper was consistent 
with the suggestions and information provided in its proposal. Australia supported non -prescriptive 
guidelines that allowed flexibility to innovate and select conformity assessment procedures that 
aligned with Members' needs, circumstances, and regulatory objectives. Australia supported 
evidence -based procedures that considered the context and met international obligations. Australia 
was of the view that the Elements Paper reflected this approach. One key suggestion from Australia 
was for a new paragraph to highlight the significance of supply chain traceability issues in conformity 
assessment, especially in modern transnational and digital markets. This, Australia said, was also a 
reflection of the recently held thematic session discussion on digital solutions where Members had 
shared experiences on supply chain and digital solutions for supply -chain traceability (see 
G/TBT/GEN/324 , dated 28 March 2022).  
2.462.   Regarding the UK's proposal on para. 3.13 (see JOB/TBT/440 , p.2), Australia stated that 
their preference was to support and retain the original text rather than the UK's proposed alternative 
text. The effect of the UK's alternative text was to recommend accreditation as the approach for 
qualifying conformity assessment bodies; Australia was of the  view that the original wording 
recognized the fact that, while accreditation was a recommended approach, it was not the only one. 
Australia supported accreditation in its own conformity assessment procedures but recognized that 
there were legitimate circu mstances where regulators could choose not to use accreditation. This 
also aligned with Australia's position that the conformity assessment guidelines should be non -
prescriptive and allow for flexibility in Members' domestic practices. More specific commen ts were 
contained in Australia's submission ( JOB/TBT/442 ). 
 
123 G/TBT/41 , para. 4.17.b  and G/TBT/46 , para. 4.18.a.   G/TBT/M/86  
 
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  2.463.   The representative of South Africa  (JOB/TBT/443 ) appreciated that the Elements Paper was 
meant to facilitate Members' work in preparing the non -prescriptive practical Guidelines to support 
regulators in their choice and design of appropriate and proportionate confo rmity assessment 
procedures – and that South Africa's proposal was, to a certain extent, reflected in the Elements 
Paper. However, South Africa made a few observations for Members' consideration.  
2.464.   South Africa said that Section 3.5 of the Elements Paper, on "acceptance of results", needed 
to deal with the matter related to Certificates of Free Sale (CoFS). This practice might not be 
consistent with the WTO TBT Agreement and could lead to unnecessary  technical barriers to trade. 
CoFS required a government of an exporting  Member to confirm: (i) that exported good was freely 
available in the market of the exporting Member, and (ii) that an exported good conformed to 
applicable standards and technical re gulations of the exporting Member. This raised a few challenges. 
As Members requiring CoFS to accompany exports were on the rise, work on the Guidelines was an 
opportunity to discipline the requests for CoFS in terms of Article 5 of the WTO TBT Agreement. An 
additional issue was that the government of the exporting  Member was required to assume 
conformance of the product instead of the economic operator – this seemed to suggest that the 
government assumed product liability. South Africa stressed that CoFS w as seen as an additional 
certificate that duplicated conformity assessment activities already undertaken by the economic 
operators. This was burdensome to economic operators and led to unnecessary technical barriers to 
trade. CoFS was unique and a special case in the context of CAP. South Africa therefore proposed 
that Members requesting CoFS replace it with technical regulations and conformity assessment 
procedures that were consistent with the WTO TBT Agreement. In this vein, South Africa proposed 
an amen dment of para. 3.14 of the Elements Paper ( JOB/TBT/443 , p.2).  
2.465.   The United States  (JOB/TBT/444 ) said that the Elements Paper was a good basis for the 
Committee to develop a very constructive guideline paper. The United States had three types of 
comments: comments from US regulators; comments from conformity assessment expert s; and, 
comments from the point of view of good regulatory practice (GRP).  
2.466.   Regarding the comments from regulators, the US comments reflected an interest to include 
the "right to regulate". The United States had included comments and corrections related to  this 
issue which were consistent with the TBT Agreement – suggesting accurate alignment with TBT 
Agreement language, relating back to technical regulations. The US regulators also had a concern 
about the use of the term "proportionality", as this was a te rm of competition law that raised multiple 
questions. This deserved discussion; for now, the US had suggested the deletion of the term from 
the text. Regarding good regulatory practice (GRP), comments related back to "notice and comment" 
and were intended to make the document more accurate and correct. With respect to conformity 
assessment, US experts had looked at clarity in language, particularly making sure that the ISO 
standards and the CASCO toolbox were accurately reflected. The United States wanted t o make sure 
that the language was broad enough to include suppliers' declaration of conformity (SDoC). In some 
cases, the text appeared to be only considering certification, some language had therefore been 
corrected. And there needed to be recognition tha t there was private sector participation in the 
conformity assessment system. In this regard, there was a comment with respect to conformity 
assessment private actors and the US wish for open competition and markets for these actors.  
2.467.   The representative of  Malaysia  (JOB/TBT/445 ) was of the  view that the Elements Paper 
provided a very good draft for Members' use. Malaysia's comments were on section 3.4: in the 
context of impartiality, independence and trust, the example of accreditation bodies and conformity 
assessment bodies was indispensab le. Therefore, Malaysia was proposing a few changes to the text 
in para. 3.12 ( JOB/TBT/445 , p.1), and also had a comment on the section on Transparency and 
consultation, in para. 3.18 ( JOB/TBT/445 , p.2).  
2.468.   The representative of Mexico  noted that her delegation's comments would be circulated 
shortly. (Mexico 's comments were subsequently circulated in JOB/TBT /452.) 
2.469.   The representative of Colombia  considered that the Elements Paper was comprehensive, 
thorough and a good basis for work. Colombia had the following preliminary comments. First, 
Colombia attached importance to the degrees  of risks referenced in the d ocument; in this regard, 
Colombia considered that moderate - and mild -risks also needed to be referred to – not only low - or 
high-risks. Second, it was important, the representative of Colombia said, to go into more depth in 
the section on market surveillan ce, and the new tendency for the use of digital methods for 
conformity assessment. These elements could be reflected in the section on strategic planning. Some G/TBT/M/86  
 
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  of this had been discussed during the recent thematic session discussion on digital solutions fo r 
conformity assessment (see G/TBT/GEN/324 , dated 28 March 2022). Colombia also said that more 
information about the use of international recommendations and the importance of cooperation 
amongst assessment bodies could be provided. For instance, there could be more references to 
metho ds pertaining to acceptance of results of conformity assessment, or mutual recognition. In the 
section on strategic planning, or the section concerning risk assessment, Colombia said it would be 
relevant to refer to surveillance and the future vision of re gulators to identify emerging risks in 
advance, such as those linked to climate change, or other issues. (Colombia's comments were 
subsequently circulated in JOB/TBT/446 .) 
2.470.   The representative of Brazil  thanked the Secretariat for their efforts in preparing this 
Elements Paper and hoped to b e able to contribute comments as well.  
2.471.   The representative of New Zealand  supported the approach taken; the development of the 
Guidelines would add a valuable resource to the Committee's work. She asked if the Secretariat 
would compile the edits made by Mem bers into one document to help with the review process.  
2.472.   The European Union  thanked the Secretariat for the Elements Paper, and Members for 
explaining their comments. The EU was of the view that the Elements Paper represented a sound 
basis on which to adva nce the discussion of the Guidelines. As had been evident in the thematic 
sessions (on both accreditation and digital solutions, see G/TBT/GEN/324) , the guidelines would 
have a key role in helping regulators identifying elements of conformity assessment they could use 
in designing ap propriate and proportionate procedures. At the time of the meeting, the EU was 
working on concrete suggestions, including on some useful aspects that had emerged from the 
discussions on digital solutions. The EU was of the view that the paper and the excha nges so far 
marked substantial progress. The EU was of the view that Members should have regular discussions 
in order to achieve a constructive result. (The EU's comments were subsequently circulated in 
JOB/TBT/455 .) 
2.473.   The representative of India thanked the Secretariat for the Elements Paper that was being 
considered in capital. He noted that it could be helpful if the Secretariat could provide a continuous 
compilation of the comments made by countries for comparison and/or analysis. The represen tative 
of India also asked how the guidelines would fit into the TBT Agreement. He suggested that Members 
could perhaps develop the Elements Paper based on good practices so that the work would become 
more substantive.  
2.474.   The Chairperson  said that the exchan ge had been very useful, and that there was good 
momentum. On process, she suggested that delegations provide any further written comments by 
13 April 2022 and that the Committee meet again to discuss the Guidelines in informal mode on 27 
April. She encour aged delegations to come forward with written comments as these would further 
enrich the document. The Secretariat would continue to circulate any comments received so that 
Members could consider them ahead of the informal meeting.124 
2.475.   The Moderators  for the  thematic sessions provided their reports. The t hematic session on 
Accreditation125 was held on 8 March in the morning ; the mo derator126's report is contained in 
G/TBT/GEN/323 . The Thematic Session on Digital Solutions127 was held on 8 March in the afternoon  
and the m oderator's128 report i s contained in G/TBT/GEN/324 .  
2.476.   The representative s of the United States  and India thanked the moderators for their reports 
and skill in moderating the sessions. The representative of India noted that there had been plenty 
of information to absorb during the morning sessions (on accredi tation) and that eleven interventions 
had perhaps been too much for one session.   
 
124 The Chairperson 's subsequent communication confirming the dates is contained in ICN/TBT/11 . 
125 https://www.wto.org/english/tratop_e/tbt_e/tbtts_e/tbtts080322am_e.htm   
126 Mr. Hélio Silva (Braz il). 
127 https://www.wto.org/english/tratop_e/tbt_e/tbtts_e/tbtts080322pm_e.htm   
128 Mr. Warren Merkel (United States).  G/TBT/M/86  
 
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  2.2.3   Other Decisions and Recommendations  
2.477.   The Chairperson  noted that, under this agenda item, Members had the opportunity to raise 
any matter relevant to follow -up on Committee Decisions and Recommendations, including those 
contained in the Ninth Triennial Review ( G/TBT/46 ), or any other previous Committee decisions and 
recommendations ( G/TBT/1/Rev.14 ).  
2.478.   On COVID -19, the Chairperson reported on discussions that  had taken place at the 10 
February  informal meeting. She noted that the Committee could consider initiat ing its work on 
COVID -19 and future pandemic preparedness ( G/TBT/46 , para. 8.4) : several Members had taken 
the floor to encourage  the Committee to start work to examine and compile best practices. In this 
respect, there had been  a suggestion from Members that the Secretariat could provide the 
Committee  with information on the work of the Committee to date since the start of the pandemic . 
This could then serve as a reference point for further  work. The Chairperson invited the Secretariat 
to prepare such a background reference document.  
3  TWENTY -SEVENTH ANNUAL REVIEW  
3.1.  The Secretariat  introduced the Twenty -Seventh Annual Review of the Impleme ntation and 
Operation of the TBT Agreement under Article 15.3, contained in  document  G/TBT/4 7. The 
Committee took note  of the report.  
4  TECHNICAL COOPERATION ACTIVITIES  
4.1.  The representative of the  United States  drew the Committee's attention to a update contained 
in document G/TBT/GEN/322 .  
4.2.  The Secretariat  reported on a new capacity building initiative: the "Transparency Champions 
Programme ". In an effort to respond to growing demands for technical assistance in the TBT area, 
the Secretariat intended to launch an innovative and comprehensive capacity buildin g programme 
on transparency. This programme , it was explained,  will offer selected government officials an 
opportunity to advance their participation in the TBT transparency mechanisms and assume the role 
of champions for transparency. Each cohort will benefit from a six -month programme, involving in -
person and virtual modules, as well as ongoing support from the Secretariat, mentors and their 
peers. Tangible results from the programme will be shared via the Committee as well as other 
communication channels , such as social media. The ultimate goal of the programme was to raise 
awareness on the importance of transparency and create a global community of transparency 
practitioners/champions.  The Secretariat noted that, given the synergies and the momentum crea ted 
by the AfCFTA, the programme would  start with a pilot segment for participants from Africa, to be 
followed by subsequent regions  to reach participants globally. The TBT Section would work closely 
with the SPS Section  in the Secretariat to run parallel programmes with a common approach.  
5  OBSERVERS  
5.1  Updates  
5.1.  The representative of UNECE  noted that it had launched the world's largest repository of 
standards mapped to the UN Sustainable Development Goals. The "Standards for SDG Portal" had 
been developed under the Working Party 6 on Regulatory Cooperation and Standardization Policies 
(WP.6) and currently  contained  maps of over twenty thousand standards of a dozen major standards 
development organizations and also provide d over forty case studies demonstrating ho w standards 
had contributed to attaining the SDGs in certain countries.  The Portal could  help governments 
identify technical standards, business standards, guidance documents, recommendations, and 
conventions that were available and that could  be used to h elp achieve the 17 goals of the 2030 
Agenda. Th e Portal129 was part of a larger project run by the UNECE Working Party 6 which include d 
work on gender -responsive standards and e -learning training on topics s uch as Conformity 
Assessment and Market Surveillance. The UNECE intended to updat e the TBT Committee on other 
aspects of this project after they ha d been completed in June  2022.  
 
129 https://standards4sdgs.unece.org   G/TBT/M/86  
 
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  5.2.  The representative of BIPM provided a report that can be accessed here130.  
5.3.  The representative of the Codex Alimentarius Commission  provided an update  contained in 
document G/TBT/GEN/ 325 and on the Codex Website . 
5.4.  The representative of OIML provided contained  in document G/TBT/GEN/ 327. 
5.5.  The Chairperson  also drew the Committee's  attention to information provided by other 
observers , including the IEC131, ISO132 and UNID O.133 
5.2  Pending Requests  
5.6.  The Chairperson  noted that an updated list of observers, including pending requests, was 
contained in document G/TBT/GEN/2/Rev.17 . Document RD/TBT/1/Rev.9  provide d an updated 
compilation of the original communications received by the WTO from the various bodies that ha d 
sought observer status in the TBT Committee and whose requests were still pending.  The 
Chairperson noted, regarding the pending request, that she had no information that would lead her 
to believe that the situation ha d changed from where the Committee stood at the last meeting. She 
therefore suggest ed that the Committ ee revert to this matter when Members had had the time to 
further consult among themselves.  
5.7.  The representative of Turkey  reiterate d her delegation's support for the Standards and 
Metrology Institute for Islamic Countries ( SMIIC )'s application for observer status in the TBT 
Committee. SMIIC , Turkey explained,  is an affiliated institution of the Organization of Islamic 
Cooperation (OIC), and , of its 43 members, 33 are also Members to the  WTO while 8 are observers. 
However , since the SMIIC's application to the TBT Committee in 2017, no progress ha d been made. 
The Members' negotiations regarding the pending requests ha d been limited to continuous 
announcements of "no consensus under this ag enda item". Annex 3 paragraph 4 of WT/L/ 161, the 
Guiding rules of Observers Status for International Intergovernmental Organizations clearly specif ied 
that each application for observer status shall be examined on a case -by-case basis. Furthermore, 
the document also clearly state d that the reque sts for observer status would be considered while 
taking into account factors such as nature of work of the organization concerned, nature of its 
Membership, the number of WTO Members in the Organization , among other factors.  Moreover, the 
delegation of Tu rkey pointed out, the document G/TBT/1/Rev.14  titled Decisions and 
Recommendations adopted by the WTO Committee on Technical Barriers to Trade since 1 January 
1995, clearly state d that it has been decided to ensure timely consideration of the requests for 
observer status and to discu ss best practices for Observers' participation in meetings of the TBT 
Committee.  In this regard, Turkey  invite d the TBT Committee to evaluate each application on its 
own merits, on a case -by-case basis , and in a timely manner in accordance with this guidance . 
Turkey express ed its readiness and willingness to be part of any effort that might be meant to 
resolve the bottlenecks in the evaluation process.  
6  ELECTION OF CHAIRPERSON  
6.1.  The Chairperson  noted that, at the time of the meeting, Members ha d not yet  finalized the 
selection process for the Chairpersons of the Committee on Trade in Goods and its subsidiary bodies, 
including the TBT Committee. This mean t that the current  agenda item would be  suspended,  and 
that the Committee would revert to at a later s tage. 
7  OTHER BUSINESS  
7.1.  The Secretariat  noted that due to the scheduling of MC12, the TBT Committee had to 
reschedule next meetings to the week starting 11 July. The Secretariat intended to organize a half -
 
130 https://www.bipm.org/documents/20126/42177518/2022 -
March+BIPM+Liaison+Report+to+WTO+TBTC.pd f/a33fe9d2 -959e-97a9-dd88-
a1dd55f5aea9?t=1647006743982  
131 iec_wto_tbt_report_2022_feb_a4_lr_0.pdf  
132 G/TBT/GEN/326 . 
133 G/TBT/GEN/ 328. G/TBT/M/86  
 
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  day symposium to discuss the value of the Committee's  work on regulatory bottlenecks and the 
global economy in the morning of 14 October 2022.  
8  DATE OF NEXT MEETING  
8.1.  The Chairperson  recalled that, due to the 12th Ministerial Conference being held in June, the 
dates of the next  regular meeting of the Committee  had to be changed. The next regular meeting 
of the Committee would now take place on 13 -15 July 2022 and would be preceded with Thematic 
Sessions on Transpar ency on 12 July (in the morning), and on Regulatory Cooperation between 
Members (MSMEs ) (in the afternoon) . 
 
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