RESTRICTED  
  
G/TBT/M/89  
 
11 May 2023  
(23-3329) Page: 1/125 
Committee on Technical Barriers to Trade   
 
MINUTES OF THE MEETING 8-10 MARCH 2023  
CHAIRPERSON: MR. ANWAR HUSSAIN SHAIK  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ ........................  2 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................ . 4 
2.1   Specific Trade Concerns ................................ ................................ ..............................  4 
2.1.1   Reported progress on STCs  ................................ ................................ ......................  4 
2.1.2   New Specific Trade Concerns  ................................ ................................ ....................  4 
2.1.3   Previously raised concerns  ................................ ................................ ......................  22 
2.2   Exchange of Experiences  ................................ ................................ .........................  118 
2.2.1   Transparency  ................................ ................................ ................................ ...... 118 
2.2.2   Conformity Assessment Procedures  ................................ ................................ ........  120 
2.2.3   Regulatory Cooperation Between Members  ................................ ..............................  121 
2.3   Other Matters  ................................ ................................ ................................ ........  122 
2.3.1   Planning of the 2023 Thematic sessions  ................................ ................................ .. 122 
2.3.2   Planning of the 10th Triennial Review  ................................ ................................ ...... 122 
3   TWENTY -EIGHTH ANNUAL REVIEW  ................................ ................................ .........  123  
4   TECHNICAL  COOPERATION ACTIVITIES  ................................ ................................ .. 123  
5   OBSERVERS  ................................ ................................ ................................ .............  124  
5.1   Updates from Observers  ................................ ................................ ..........................  124 
5.2   Pending requests  ................................ ................................ ................................ .... 124 
6   ELECTION OF CHAIRPERSON  ................................ ................................ ...................  124  
7   OTHER BUSINESS  ................................ ................................ ................................ .... 124  
8   DATE OF NEXT MEETING  ................................ ................................ .........................  125  
 
  
 
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/89  
 
- 2 - 
 
  1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda in WTO/AIR/TBT/2 5. 
1.2.  The representative of Paraguay  wished to raise the issue of the functioning of the CTG and its 
subsidiary bodies contained in  JOB/CTG/21  and JOB/TBT/498 .  
1.3.  The representative of Ukraine  inform ed Members about  relevant activities in the field of 
technical regulation. Despite full -scale war unleashed by Russia, which  had now lasted for one year 
and 11 days , Ukraine remain ed strongly committed to the fundamental rules of the WTO  and ma de 
every effort to ensure th e transparency of measures adopted by the Government of Ukraine under 
martial law.  Russia continue d to demonstrate a flagrant disregard for international law and  did not 
stop in its acts of state terrorism against Ukraine and Ukrainian civilians by attacki ng critical 
infrastructure and residential areas resulting in significant casualties and destruction.  Nevertheless, 
Ukraine continue d to take steps to ensure the proper functioning of the system of technical 
regulation s and steady work in the field of stan dardization and metrology  in wartime conditions. To 
date, in Ukraine,  46,191 national standards ha d been adopted in Ukraine, of which 38,412 
international and European standards ha d been adopted as national ones.  The National 
Standardization Program for 20 23 provide d for the development of 1,843 draft national standards, 
of which 1,133 standards would  be harmonized with international and European standards.  
Currently, there were 165 technical standardization committees operating in Ukraine in various 
sector s of the national economy, which include d representatives of public authorities and business, 
educational, scientific , and technical societies , and consumer organizations . Today, the 
infrastructure of designated bodies responsible for conformity assessment  with the requirements of 
technical regulations consist ed of 69 accredited bodies (including two recognized independent 
organizations).  For the time being, all the 69 designated bodies located in different regions of Ukraine 
continue d to carry out the full  conformity assessment procedure at their permanent locations.  Among 
them, 14 bodies were responsible for the conformity assessment of measuring instruments with the 
requirements of technical regulations in the field of metrology. In addition, there were 73 authorized 
verification laboratories that carr ied out metrological activities.  At the same time, in some regions 
of Ukraine, scientific and production center s for standardization, metrology , and certification had 
been seriously affected by the war. Kherson, Luhansk, and Donetsk regional research centres  for 
standardization, metrology, and certification had been forced to cease their operations.  Despite  the 
wartime conditions , Ukraine remain ed committed to transparency and notifying Members  about their 
legislation. Since the beginning of the war, Ukraine ha d submitted 70 notifications and replied to 50 
Members ' requests related to TBT issues.  Ukraine was grateful to all WTO Members that  had stood 
with them in resolutely  opposing Russia's brutal war against Ukraine and its people.  
1.4.  The representative of Canada  noted that it had been more than a year since Russia's illegal 
invasion of Ukraine , an event that ha d had a catastrophic effect on Ukraine, its neighbours, and 
people  around the world. For a year Ukraine ha d endured  staggering levels of destruction and human 
suffering and its ability to participate in the global trading system ha d been severely impaired. 
Canada stressed the need to stand united against this unprovoked and illegal invasion and its 
attempted annexations.  
1.5.  The representative of the United States  condemn ed Russia 's illegal, unjustifiable, and 
unprovoked war , its disregard for the Charter of the United Nations , and indifference to the impacts 
that its war was having on people worldwide. Russia's actions had also contravene d the principles 
and values that were the foundation of the WTO, including other Members ' shared notions of fairness  
and openness. Meanwhile, Ukraine continue d to notify its regulations to the WTO despite the 
unimaginable conditions they face d. We commend Ukraine 's commitment to transparency and to 
this organization.  
1.6.  The representative of the European Union  welcomed Ukraine 's efforts to integrat e into the EU 
internal market, including through very close collaboration on standardization as well as alignment 
with EU technical regulations and quality infrastructure.  The EU also praise d Ukraine 's efforts to 
submit notifications and reply to questions  despite the war. This clearly demonstrate d their strong 
commitment to the WTO work.  The European Union condemn ed in the strongest possible terms the 
Russian Federation's unprovoked and unjustified military aggression against Ukraine, as well as the 
illega l attempt ed annexation by Russia of some regions of Ukraine. This aggression deeply violate d 
international law and undermine d international security and stability. War crimes committed against 
Ukrainians, of which there was growing evidence, and the contin uous destruction of civilian G/TBT/M/89  
 
- 3 - 
 
  infrastructure , was a flagrant violation of international law. The European Union called on the Russian 
Federation to immediately end its acts of aggression, withdraw its troops from Ukraine , and fully 
respect Ukraine 's territo rial integrity, sovereignty, and independence within its internationally 
recognized  borders. The European Union stood  firmly with Ukraine and its people for as long as it  
would take.  
1.7.  The representative of New Zealand  thanked Ukraine for the  steps  taken  to ensure the proper 
functioning of its technical regulation system despite the massive destruction brought on by Russia's 
illegal invasion. Last month mark ed one year since Russia launched its illegal invasion of Ukraine . 
New Zealand remain ed resolved to stand against Russia's aggression and alleged atrocities 
committed in Ukraine. New Zealand st ood with Ukraine in supporting its sovereignty and territorial 
integrity. Russia ha d massively destr oyed global production and trade through its illegal and  
unprovoked attack s on one of th e leading food producers, as well as its destruction of Ukraine's 
civilian infrastructure and the blockading  of ports . These Russian actions had a clear and devastating 
impact on Ukraine and the global economy.  
1.8.  The represent ative of the United Kingdom  affirmed unwavering support for Ukraine  in line with 
remarks from other colleagues . Russia 's continued war of aggression ha d reached the sad mark of 
one year . This was  one year after Russia had illegally invaded another sovereign nation , and the 
impacts of th e brutal act continue d to be felt. The UK  was also conscious of the consequences of this 
brutal war of aggression on the ability of Ukraine to participate in the TBT Committee and the WTO. 
The UK  applaud ed the efforts  to comply with TBT obligations  and admire d the courage and bravery  
of Ukraine , who, despite the dire circumstances, stood  firm against Russia. The consequences of 
Russia 's actions span ned across the globe and were directly felt in the multilateral trading  system 
as well  – not to mention the huge cost to civilian lives . Ukrainian exporters were also directly 
affected, with infrastructure destruction  and supply -chain disruptions resulting directly from this 
illegal war. Over the last year , the UK and its allies ha d continued to outline the enormous global 
impact of Putin 's actions, and the UK would continue to do so for as long as it t ook. 
1.9.  The representative of Japan  noted that a  year ha d passed since Russia began its aggression 
against Ukraine. Japan strongly condemn ed Russia 's aggression against Ukraine and its missile 
attacks against civilian infrastructure and cities across Ukraine.  As the only country to have ever 
suffered atomic bomb ings during wartime, Japan could not  accept Russia 's nuclear threats, let alone 
its use of nuclear weapons under any circumstances. Japan urged Russia  again to stop the 
aggression and withdraw its forces from the territory of Ukraine within its internation ally recognized 
borders immediately. Japan would  also continue to work firmly on the two pillars of imposing strong 
sanctions against Russia and supporting Ukraine in cooperation with the international community.  
1.10.  The representative of Australia  thank ed Ukraine for its  update and acknowledge d the 
challenging circumstances impacting Ukraine 's participation in the work of the WTO , and commend ed 
Ukraine 's commitment to transparency.  In this broader context, Australia echo ed others : it 
reiterated  its condemnati on of Russia 's illegal invasion of Ukraine, a gross violation of international 
laws, including the Charter of the United Nations. Australia strongly support ed Ukraine 's sovereignty 
and territorial integrity and call ed on Russia to cease its attacks and wit hdraw its forces from 
Ukrainian territory.  
1.11.  The representative of Switzerland  condemned Russia 's military aggression on Ukraine in the 
strongest possible terms. This was a serious violation of international law. Russia's actions violate d 
the prohibition of the use of force and the territorial integrity and sovereignty of Ukraine, as 
enshrined in international law. Switzerland call ed on Russia to respect its international obligations 
and to reverse its actions as well as to withdraw its troops and contribute to the de-escalation. 
Switzerland call ed on all actors to respect international law , including international communitarian 
law. 
1.12.  The representative of the Republic of Korea  commended Ukraine for its continued efforts in 
transparency despite challenging circumstances and reaffirm ed its consistent position that the 
sovereignty, territorial integrity , and independence of Ukraine had to  be respected. Korea, as a 
responsible Member of the international community, support ed various diplomatic and e conomic 
efforts of the international community to contribute to the end of the war and the restoration  of 
peace : Korea would actively participate in those efforts.  G/TBT/M/89  
 
- 4 - 
 
  1.13.  The representative of the Russian Federation  noted that while he had not raised  a point of 
order , some  of the interventions clearly fell outside  the mandate of the present Committee. Multiple 
times, Russia  had repeated that the discussions of the regional or global security situation,  the UN 
Charter  - the enforcement or compliance  thereof – evidently went  beyond the mandate of not just 
this TBT Committee but the WTO itself. Trade diplomats did not  have the expertise to discuss these 
issues as these discussions belong ed to the specialized UN bodies and agencies; it was in these 
agencies that Russia  share d positions on the rules and reasons for special military operation , as well 
as on the issues that have arisen  during the conflict. Regarding the allegations of food security 
disruptions, as Russia had stated on numerous  occasions,  the significant contribut ing factor  to the 
current global crisis was unilateral trade -restrictive measures with extraterritorial  implications by 
the Members that had just taken the floor .  
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
2.1.1   Reported progress on STCs  
2.1.  The representative of the United Kingdom  provided the following statement. We express 
support for th e initiative of this "good news" agenda item, to highlight the good work and 
collaboration in this Committee. We hope that many Members will have the opportunity to speak 
under this item in the future and we definitely had several productive discussions wi th Members this 
year. Today we would like to notify to this Committee that we have withdrawn STC No 666 (Kingdom 
of Saudi Arabia - Technical Regulation for limiting and restricting hazardous materials in electrical 
and electronic equipment ). We held a seri es of productive exchanges bilaterally and together with 
other interested Members , and are happy to report that our main concerns regarding this measure 
have been addressed by the Saudi Standards, Metrology and Quality Organization. Working together 
with o ther Members on issues of mutual interest and involving regulators early in the process, was 
particularly helpful and facilitated the prompt resolution of our concerns. We would like to thank the 
Kingdom of Saudi Arabia for their engagement and would like to take this opportunity to emphasize 
that this is the type of outcome which we strive to achieve through our engagement in this 
Committee. By enabling this type of technical and focussed exchange and its associated functions, 
this Committee can greatly co ntribute to the facilitation of international trade, reducing trade barriers 
and preserving Members' right to regulate.  
2.2.  The representative of the United States  provided the following statement. W e would like to 
provide a  positive development  update on a bi lateral STC we raised on the margins of the past few 
Committee meeting s, on Viet  Nam Draft Circular Guidelines on Nutrition Labeling of Foods notified 
as G/TBT/N/VNM/219 . During our meetings on the margins of the Committee meeting, Viet  Nam 
provided a helpful feedback confirming that it would  extend the implementation period for this 
measure to two years and will increase flexibilities for products that are on the market before the 
measure goes into force following requests by the United S tates.  Further, Viet  Nam confirmed that 
alcohol would  not be included in the scope of this measure. We greatly appreciate this update, which 
directly answered some of the questions we had posed on this measure.  There was also constructive 
communication bet ween Enquiry Points and Geneva mission representatives that resulted in 
Viet Nam notifying the Draft Circular to the Committee in April of 2022. We look forward to continued 
bilateral engagement on this matter as Viet  Nam further considers policy options, guidelines, and 
subsequent implementing measures, and thank Viet  Nam for its previous responses.  
2.1.2   New Specific Trade Concerns  
2.1.2.1   Panama - Technical Regulation for Milled and Paddy Rice, G/TBT/N/PAN/118 , 
G/TBT/N/PAN/120  (ID 7822) 
2.3.  The representat ive of the United States  provided the following statement. On 14 June 2022, 
Panama notified a new draft regulation on rice detailing the grade and quality standards. The United 
States submitted comments prior to the deadline which identify important concerns regarding these 
measu res. Panama's draft regulations appear to deviate from the relevant international 
standards  CXS198 -1995 (ISO -7301-2021). We respectfully ask Panama to provide a scientific 
 
2 For previous statements follow the thread under ID 782 . G/TBT/M/89  
 
- 5 - 
 
  and/or technical justification or rationale for not using relevant existing internat ional standards 
guidance for the grading standards developed. We are very concerned with the technical aspects of 
these regulatory proposals which continue to be vague. We ask Panama to describe each 
requirement with specific detailed parameters and metric s. In addition, we request that those 
parameters are written into the regulation to allow continuity. The United States requests that 
Panama continue to accept US rice grading standards (§868.212; §868.210) as fulfilling its 
regulatory objective, as has lo ng been the established practice. We note that USDA rice grading 
standards are consistent with international standards and are widely accepted across the world. The 
United States is concerned that Panama appears to be developing technical regulations that are not 
least trade restrictive and may be applied to protect sensitive domestic products. We urge Panama 
to take trading partners' concerns into account before advancing any regulatory action. We invite 
Panama to engage in technical dialogue in this area as soon as possible.  
2.4.  In response, the representative of Panama  provided the following statement. Panama thanks 
the United States for its interest in the Panamanian Technical Regulation for rice. We also thank the 
US technicians who are with us in today's m eeting in relation to our bilateral meeting this week.  We 
have listened carefully to your intervention and also to the points shared in our bilateral meeting. 
We have conveyed the concerns to our authorities and look forward to having more information 
soon. We emphasize that the talks remain at an early stage, and the regulation has not entered into 
force, and we therefore continue to study the comments we have received from our trading partners.  
However, like the United States, Panama wishes to resolve thi s trade concern bilaterally, and 
accordingly we trust that discussions under the Trade Promotion Agreement between our authorities 
and the US industry can lead to mutually satisfactory solutions.  
2.1.2.2   European Union - Proposal for a Regulation of the European P arliament and of the 
Council on shipments of waste and amending Regulations (EU) No 1257/2013 and (EU) 
No 2020/1056, G/TBT/N/EU/893  (ID 7833) 
2.5.  The representative of Indonesia  provided the following statement. Indonesia would first like to 
thank the E uropean Union for its notification G/TBT/N/EU/893 , Proposal for a Regulation of the 
European Parliament and of the Council on shipments of waste and amending Regulations (EU) 
No 1257/2013 and (EU) No 2020/1056 (COM(2021) 709 final) ("the proposal"), which was submitted 
on 25 May 2022. As some concerns were raised, Indonesia submitted an enquiry on 
23 December  2022. Indonesia realizes that the enquiry submission was overdue the commenting 
period, however, we appreciate if the EU could deem the enquiry as an effort to seek further 
clarification and detail information on the notified measure. The said notification provided 
information on a draft regulation that would replace the current Regulation (EC) 1013/2006 on 
shipments of waste. This draft Regulatio n establishes procedures and control regimes for waste 
shipments, taking into account the origin, destination and route of the shipment, the type of waste 
shipped and the type of treatment to be applied to the waste at its destination. It provides procedur al 
rules for shipments of waste both within, to, and from the Union.  
2.6.  Indonesia appreciates the EU's intention to take serious measures to minimize the risks that 
may endanger  public health, as well as any environmental impacts that would arise due to 
unman aged waste shipments. However, Indonesia would like to echo the discourse stated in the TBT 
Agreement whereby measures prepared to achieve legitimate objectives, it shall be assumed not to 
create unnecessary obstacles to international trade. Indonesia is c oncerned that there are indications 
of discrimination in this proposed regulation, in which the EU will restrain the export of non -
hazardous waste, by establishing excessive administrative arrangements for exports to destinations 
outside EU member States a nd OECD countries. This draft proposal also does not differentiate 
between the treatment of hazardous waste and non -hazardous waste (green list), which can be 
reused as industrial raw materials to support the circular economy. According to the terms of tra de 
in the World Trade Organization (WTO), all countries should have the same position in accordance 
with the Most Favored Nation (MFN) principle and must emphasize the principle of fair trade, and 
Indonesia and the EU should have the same equality as they are state parties to the WTO, Basel 
Convention and other international multilateral agreements.  
2.7.  The pulp and paper industry will be one of the sectors significantly affected by this proposed 
regulation. The provisions in this proposal also regulate export restrictions and mechanisms for 
recycled paper, which is essential as a raw material for the Indonesian paper industry. As the 
 
3 For previous statements follow the thread under ID 783 . G/TBT/M/89  
 
- 6 - 
 
  domestic waste collectors have not been able to meet the demand for recycled paper in terms of 
quality and quantity, the import o f recycled paper from the EU is the preferred solution. The import 
value of recycled paper reached IDR 17.4 billion with a volume of 1.9 million tonnes. Indonesia has 
the same intention on environmental protection which has been a global issue and the need  to 
escalate the implementation of circular economy, reducing greenhouse gas emissions (Net Zero 
Emissions) and others in addressing the issue. However, the recycling rate is still very low so there 
is still a shortage of recycled materials, one of which i s recycled paper. Indonesian recycled paper 
can only meet about 50% of the total industrial demand, while the demand for packaging paper in 
the country is increasing. Packaging paper is highly needed as a supporting industry for other 
developing industrial  sectors such as packaging industry, the food and beverage industry, the 
footwear industry, the electronics industry, etc.  
2.8.  As for the recycled paper that Indonesia imports mainly comes from the EU, so if the EU 
implements these proposed  regulations, which we believe could prevent our industry from obtaining 
raw materials, then this will not be in line with the circular economy program both in Indonesia and 
in the EU itself. We have received information that the total availability of recy cled paper raw 
materials in the EU is 54.4 million tons, but only 47.9 million tons could be absorbed by the EU pulp 
and paper industry. The pulp and paper industry is also obliged to comply with the regulations set 
by the Indonesian Government, including those related to environmental management aspects such 
as waste management; green industry; greenhouse gas emissions; quality standards on emissions; 
employment; as well as regulations for the purpose of importing waste to be used as raw material. 
The Indo nesian government has a strong commitment in addressing climate change issues, reducing 
emissions, and improving environmental aspects. Gradually, Indonesia is committed to increase its 
GHG emission reduction target, which will be in line with the Long -term Strategy for Low Carbon 
and Climate Resilience (LTS -LCCR 2050) policy towards net -zero emission in 2060 or earlier. 
Indonesia's GHG emission reduction target with its own capabilities in the Updated Nationally 
Determined Contribution (UNDC) was increased  to 31.89%, while the target with international 
support in the UNDC was increased to 43.20% in the Enhanced Nationally Determined Contribution 
(ENDC). This commitment is followed by updating national policies related to climate change, such 
as related sect oral policies, including Indonesia Forestry and Other Land Uses (FOLU) Net -sink 2030, 
accelerating the use of electric vehicles, B40 policy, increasing measures in the waste sector, such 
as the use of sludge installations wastewater disposal (IPAL), increa sing targets in the agricultural 
and industrial sectors, implementation of Green Industry, Low -Carbon Development and many more.  
2.9.  The arrangements of the importation Non -hazardous waste in Indonesia has been regulated in 
such a way as to ensure  that it has been imported in accordance with the applicable regulations and 
that the importer can carry out waste treatment. This means that Indonesia is very concerned about 
the quality of recycled paper sent to Indonesia, so if the EU is going to conduct an audit, i t should 
be done in the country of origin and not in the country of export destination. In view of the above, 
and in order to minimize potential technical barriers to trade due to the existence of the EU WSR 
proposal, Indonesia would like to urge the EU to  respond to our enquiry. We further seek the 
possibility to be designated as one of the "Listed Countries" and to be exempted from the 
administrative as well as certification requirements that are time consuming and costly. 
Furthermore, we are ready and ea ger to fulfil our commitment as stated in enhancing NDC. Indonesia 
looks forward to further engagement with the EU on this issue.  
2.10.  The representative of Türkiye  provided the following statement. We would firstly like to thank 
the EU for their cooperation. W e have had a chance to meet with the EU delegation on the margins 
of the last TBT Committee meeting and in fact in the course of time since then bilaterally. That said, 
we still have concerns regarding this regulation and we would like to state them today.  In fact, 
Türkiye shares the stated EU objectives with this regulation of supporting the transition to a green 
and circular economy. However, we believe that the monitoring and inspection requirements and 
measures envisaged in the draft for waste shipments  of especially recycled raw materials of certain 
industries go beyond the stated legitimate environmental objectives. In this regard, we believe that 
the trade restrictive nature of these measures might be incompatible with EU's international 
commitments.  
2.11.  First of all, the draft lacks clear conditions for "monitoring of export and safeguard procedure" 
and for the inspection requirements of the importer facilities. These might lead to restriction of waste 
exports; and might impose additional burden and costs  on importers while creating technical barriers 
to trade. Secondly, the draft legislation does not distinguish potentially hazardous waste streams 
such as mixed plastic waste from secondary raw materials being used as a raw material of certain G/TBT/M/89  
 
- 7 - 
 
  industries. This approach undermines the benefit of trade in certain secondary materials, which 
contribute to low emission production and thus boost global circularity. In this sense, we believe the 
draft legislation may endanger the supply of raw materials for third countries' recycling facilities, 
hampering the already functioning circular economy in these countries. For instance, taking into 
consideration that 53.4 % of the ferrous scrap, 52.8 % of non -metal waste is imported from the EU 
to Türkiye, Turkish recyclin g industry and steel production is highly dependent on the supply received 
from the EU. On the other hand, it is important to underline that under the Paris Agreement, it is 
part of an international collective effort to reduce the carbon emissions signific antly. Therefore, 
global cooperation is significant in this regard.  
2.12.  Furthermore, Basel Convention and related OECD Decision already set the rules for 
transboundary movements of hazardous waste. In this sense, this draft regulation might be 
inconsistent wit h Article 2.4 of the TBT Agreement. In that respect, Türkiye would like to ask 
information to the EU on the negative environmental impact justifying the need for the 
implementation of additional requirements in the draft? What constitutes the basis for imp osing 
certain measures to monitor and when necessary restrict trade of ferrous scrap and non -metal non -
hazardous waste for environmental protection concerns? Furthermore, Türkiye has been 
harmonizing relevant EU legislation with regards to waste management . Facilities in Türkiye that 
manage, recycle and import waste are already subject to licensing and auditing requirements. 
Therefore, the requirements foreseen by the legislation will bring additional burden for our facilities. 
In that respect, Türkiye woul d like to ask whether similar additional monitoring and auditing 
requirements will be introduced for the EU member States as well.  
2.13.  In response, the representative of the European Union  provided the following statement. As 
indicated in the notification form , this notification was made for transparency purposes and does not 
prejudge the Union's position as to the applicability of the TBT Agreement.4 The volume of exports 
of waste from the EU is considerable (33 million tonnes in 2020) and has substantially increased in 
the last decade (+75% since 2004). Waste shipped across borders can generate risks for human 
health and the environment, especially w hen not properly controlled. The notified draft, in line with 
the EU's commitments under the European Green Deal, the Circular Economy Action Plan and the 
Zero Pollution Action Plan, aims to ensure that the EU does not export its waste challenges to third 
countries, seeks to tackle illegal waste shipments and seeks to contribute to the circular economy 
by facilitating shipments of waste for reuse and recycling in the EU. The EU welcomes that Indonesia 
indicates that it also shares the importance of a transi tion to a green and circular economy and the 
management of waste in an environmentally sound manner.  
2.14.  The EU reiterates that the notified draft does not prohibit international shipments of waste. 
In order to avoid that exported waste emanating from the EU h arms the environment or public 
health in countries  outside of the EU, the notified draft includes provisions designed to ensure that 
the export of waste from the EU only takes place when there are sufficient guarantees that this 
waste will be managed in an  environmentally sound manner in the country of destination. Waste 
treated in the EU is already subject to strict rules designed to protect the environment and human 
health. Waste treatment facilities in the EU are in addition subject to inspections and en forcement 
measures by national competent authorities in the EU member States. In this context, the notified 
draft includes provisions which are designed to ensure that waste exported outside the EU is 
managed in the countries of destination in conditions t hat are "broadly equivalent" to EU conditions 
to underpin the environmentally sound management of waste. It therefore aims to achieve the EU's 
environmental and public health objectives by ensuring there is a coherent regulatory approach to 
waste treated i n the EU and waste exported from the EU to third countries. When assessing "broad 
equivalence", full compliance with requirements stemming from EU legislation shall not be required, 
but it should be demonstrated that the requirements applied in the third c ountry of destination 
ensure a similar level of protection of human health and the environment than the requirements 
under the EU legislation.  
2.15.  The principle  that all waste should be managed in conditions that are "broadly equivalent" to 
EU conditions when exported outside the EU is already reflected in the current EU legislation on 
waste shipments.5 The notified draft is designed to ensure that the provisions on "broadly equivalent 
 
4 The notified draft was also notified to the Environment Committee on 2 June 2022.  
5 Regulation (EC) No 1013/2006 of the European Pa rliament and of the Council of 14 June 2006 on 
shipments of waste; OJ L 190, 12.7.2006, p. 1 –98 - 
 G/TBT/M/89  
 
- 8 - 
 
  conditions" are made fully operational, and is intended to overcome persist ing implementation 
difficulties associated with the lack of clear criteria on this point in the current Regulation. In that 
respect, the notified draft is necessary to secure compliance with the EU's regulatory regime for 
waste management. The EU reiterate s that the notified draft does continue to distinguish between 
hazardous and "green -listed waste" relating to the applicable respective procedures for such wastes, 
but that it considers as well that the environmental objectives can only be met if the requi rements 
relating to the environmentally sound management of waste apply to all types of waste exported 
from the EU. This principle is reflected in the existing legislation as well. In that respect, the EU 
notes that "green -listed waste" can also potentiall y cause environmental damage if not managed in 
an environmentally sound manner. The criteria designed to demonstrate that waste is managed in 
an environmentally sound manner, are laid down in the notified draft.  
2.1.2.3   China - Interim Regulation on Radio Manageme nt of Wireless Charging (Power 
Transmission) Equipment, G/TBT/N/CHN/1711  (ID 7846) 
2.16.  The representative  of the United States  provided the following statement. The United States 
would like to raise concerns today with China's draft Interim Regulatio ns on Radio Management of 
Wireless Charging Equipment. We understand this regulation specifies the technical requirements 
and radio frequencies that will be mandatory for a variety of wireless charging equipment produced 
or used in China, such as mobile de vices, smartwatches, and electric vehicles. We thank China for 
its notification of the measure to the TBT Committee in November 2022, however we note that the 
proposed date of adoption was January 2023, the same month as the deadline for stakeholders to 
provide input. Given this, we ask China to clarify the status of the measure, as well as how China 
took into account the comments received during the comment period? The United States and US 
industry submitted written comments to China in January, and while we await China's response, we 
think it is important to highlight several of our concerns in the Committee given the significant 
impact this measure may have on international trade.  
2.17.  First, China's  TBT notification states that the objective and rationale for  issuing this draft is 
for quality requirements and harmonization. However, one of the frequency ranges China proposed 
to adopt is not included in the relevant ITU -R standard (SM.2129). Can China please explain why it 
has included this additional frequency  range (13553 -13567kHZ) that is not in the published 
international standard? As many in this Committee may be aware, the ITU is in the process of 
revising this standard, and it is expected to be completed soon. The draft revision is taking multiple 
frequen cy ranges into consideration, such as 315 -400kHZ, which we understand has demonstrated 
substantially lower energy consumption. We encourage China to delay finalization of the measure 
until it has taken into consideration the revised international standard and can use it as a basis for 
China's regulation, in order to harmonize with international consensus.  
2.18.  Second, regarding  electric vehicle wireless charging equipment, we note that the SAE 
International has developed standard J2954, and standard J2954/2. Cou ld China explain how it 
considered these standards when developing its draft measure? We request that China use these 
two standards as a basis for its regulation. Third, has China conducted a regulatory impact 
assessment on the potential negative environme ntal and climate impacts of limiting the frequency 
ranges? As we understand it, chargers that operate at the frequency range of 315 -400 kHZ and 1.7 -
1.9MHZ for portable devices, which would not comply with the proposed measure, are able to 
consume less over all energy due to their quick charging ability and are already in use by millions of 
devices in many markets.  
2.19.  Fourth, Article  14 of the draft measure states that beginning in 2024, equipment that does 
not comply with the requirements of this measure may no  longer be produced in China or imported 
into China. It also states that devices that comply with the previous measure that have been put 
into use may be used until scrapped. Could China please address products that have already been 
imported or produced b ut that have not yet been put into use, for instance, those stored in facilities 
in China for sale? We urge China to consider flexibility to avoid unnecessary mass disposal or export 
that would result in increased electronic waste. Furthermore, US industry  has indicated that China's 
proposed one -year transition (for 2024) is unreasonable and would pose significant challenges for 
compliance. If China decides to move forward with these requirements, we ask China to provide 
 
https://eur -lex.europa.eu/legal -content/EN/TXT /?uri=CELEX%3A02006R1013 -
20210111&qid=1670254090535 .  
6 For previous statements follow the thread under ID 784 . G/TBT/M/89  
 
- 9 - 
 
  additional transition time for this regulation. We appreciate the opportunity to discuss these matters 
further.  
2.20.  The representative  of Japan  provided the following statement. Japan has concerns with regard 
to the China - Interim Regulations on Radio Management of Wireless Charging (Power Transmission) 
Equipment. The Interim Regulations stipulate the frequencies which wireless charging (power 
transmission) equipment must comply with. The frequencies used for the wireless charging (power 
transmission) equipment are set by international standards from the Wireless Power Consortium 
(WPC) and the International Telecommunication Union Radiocommunicat ion Sector  (ITU-R). 
Furthermore, WPC has decided to revise the Qi standard, and ITU -R has also decided to revise the 
guidance. However, the Interim Regulations exclude 360kHz, which is scheduled to be included in 
WPC's Qi2.0. The Interim Regulations also e xclude 315 -400kHz and 1700 -1800kHz, which are 
scheduled to be included in ITU -R's revised guidance. Therefore, the Interim Regulations do not use 
the international standards as a basis and would be inconsistent with Article 2.4 of the TBT 
Agreement. Japan requests China to clarify why the Interim Regulations do not use International 
Standards as a basis.  
2.21.  China has explained  that the purposes of the Interim Regulations is to regulate the use of 
wireless charging (power transmission) equipment, to avoid harmf ul interference to the services 
complying with the law, and to maintain the order of the radio wave. However, it is considered that 
adopting the international standard Qi2.0 of WPC and the revised guidance of ITU -R enables China 
to achieve these purposes. Therefore, the Interim Regulations, which prohibit the import, sale and 
use of products that comply with international standards, are likely to be an unnecessarily trade -
restrictive measure and can violate Article 2.2 of the TBT Agreement. Japan requests t hat China use 
international standards as a basis for formulating the Interim Regulations on Radio Management of 
Wireless Charging (Power Transmission) Equipment so that the Interim Regulations do not become 
unnecessarily trade -restrictive measures.  
2.22.  The representative  of the European Union  provided the following statement. The EU would 
like to support the delegations of the United States and Japan. On 13 January 2023 the EU sent its 
comments on notification G/TBT/N/CHN/1711  to China. To date we did  not receive China's reply, 
therefore the EU would like to recall its main concerns expressed therein. As regards the technical 
aspects for mobile phones and portable equipment charging, the China regulation foresees that the 
mobile and portable wireless c harging equipment shall work within the frequencies of 100 -148.5 
kHz, 6765 -6795 kHz and 13553 -13567 kHz, the rated transmitted power shall not exceed 50W and 
the radiation parameters shall meet the Specifications of Wireless Charging (Power Transmission) 
Equipment. Considering the results of the study commissioned by European Commission on wireless 
charging technologies for mobile phones and similar portable equipment, limiting the lower 
frequency range to 100 -148.5 kHz (instead of 87 -205 kHz) would make a number of existing 
chargers and devices non -compliant. In addition, the EU would like to recall that the Qi technology, 
the main used worldwide, has a broader range than the one proposed by China.  
2.23.  Furthermore , given that wireless charging technology is sti ll evolving, over -restricting the 
technology (such as the frequency range and others) could stifle innovation. It is for this reason that 
Directive (EU) 2022/2380 introduces technical requirements for wired charging only. Concerning 
Article 11, the EU woul d like to recall the trend of portable wireless charging devices is 
miniaturization. China's requirement to display the sentence "wireless charging equipment" could be 
problematic due to space constraint. In the EU, manufacturers are requested to display v arious 
information on the product, however, this is usually done in a form of pictogram/visual element, not 
as a sentence or a wording. The EU welcomes that Article 11 of Interim Regulations allows the 
labelling in the instruction manual due to the size of  the product. However, as there is no specific 
regulation on the size of the product itself, this provision could lead to unnecessary disputes in the 
post-supervision links after the implementation of the regulations. The EU would therefore like to 
suggest  to China to either display the sentence as a sticker on the product or on the packaging; or 
to foresee an exclusion of displaying the sentence for small products, clearly indicating their size; or 
to allow adding the requested information ("wireless charg ing equipment") on the packaging instead 
of placing it directly on the device. The last option was applied in Directive (EU) 2022/2380 to display 
the charging characteristics (label) and the presence or not of a charger in the box (pictogram).  
2.24.  Regarding Ar ticle 14 of Interim Regulations, the EU requested an extension of transition period 
to two years, to allow for a smooth transition. The global supply chain has been impacted by the 
pandemic, and many companies including Chinese companies are currently in t he predicament of G/TBT/M/89  
 
- 10 - 
 
  component shortages. In addition, the life -cycle of re -designing products or the development of new 
products usually takes years, and destocking is also a long -term process. The EU takes this 
opportunity to recall that for these reasons i t was decided to have a transition period of two years 
for the proposal on the common charger for mobile phones and similar equipment under the Radio 
Equipment Directive 2014/53/EU, thus ensuring that industry has sufficient time to adapt. The EU 
would als o like to propose an additional two -year grace period for after -sale service components, 
which would translate into a total grace period of four years for the manufacturers and importers of 
after-sale service components. Without the introduction of such ad ditional grace period, many users 
would suffer losses due to unavailability of after -sale services. Should the Interim Regulations 
prohibit enterprises from making old product components for after -sale services, it would result in 
more waste and additional  market access barriers.  
2.25.  In response, the representative of China  provided the following statement. China would like 
to thank the United States, Japan and the EU for their comments on the Interim Regulation on Radio 
Management of Wireless Charging Equipmen t. With regards to the range of the operating frequencies 
of wireless charging equipment, based on relevant recommendations from the International 
Telecommunication Union (ITU) and the development status of the industry , the Ministry of Industry 
and Inform ation Technology of China has specified three frequency bands for mobile and portable 
wireless charging equipment, namely 100 -148.5 kHz, 6765 -6795 kHz and 13553 -13567 kHz. 
Currently, as there is not enough compatibility analysis between these three bands a nd others, 
introducing new bands may cause harmful interference with existing services and systems. The 
interim regulation is subject to future adjustments as made necessary by the advancement of the 
industry and technology. The definition of wireless char ging equipment in Article 2 involves the 
power receiver, which is because the working mechanisms of wireless charging are based on 
magnetic coupling  (induction, resonance) and capacitive coupling, etc, involving the joint action of 
transmitter and receiver  to enable power transfer.  
2.26.  Suggestions  regarding article 11 will be considered. The interim regulation will no longer 
require marking or displaying the words "wireless charging equipment", but to use "special 
identification" for labelling. If conditions do  not permit, it can be shown on independent outer 
packages or in the instructions of the products. Regarding Article 14, in consideration of producers' 
R&D and production cycle, the Interim Regulation will set up a reasonable transitional period, which 
will facilitate the industry to prepare and coordinate before its implementation. Meanwhile, wireless 
charging devices that are produced or imported before the deadline of the transitional period, can 
continue to be sold and used until they are scrapped. Rega rding the testing method for wireless 
charging equipment, the Ministry of Industry and Information Technology is currently organizing the 
development of related standards, which will serve as the basis for testing when published.  
2.1.2.4   India - Standards and Labe lling Program for Washing Machines (ID 7857) 
2.27.  The representative  of the Republic of Korea  provided the following statement. First of all, 
Korea respects India's efforts to protect its environment and the safety of consumers through energy 
efficiency regula tions, and Korean companies are making efforts to comply with Indian regulations 
as such. With regard to the Standards and Labelling Program for Washing Machines provided by 
India's BEE (Bureau of Energy Efficiency), Korea submitted letters stating the con cerns of the Korean 
industry through the Indian Enquiry Point on 5 January and 8 February this year, but we have not 
yet received a response, and we would like to convey our comments once again. First, the energy 
efficiency regulation for washing machines by BEE is currently implemented as a voluntary 
certification scheme, but it is noted that it shall be changed to a mandatory scheme as of 1 July 
2023 without any WTO TBT notification. In relation to this issue, in the draft amendment to energy 
efficiency r egulation for washing machines distributed at the BEE Tech meeting held for local 
companies, clauses 1.(c) and 6.7 specify that not only energy efficiency requirements but also safety 
standards (IS 302 -2-7) must be satisfied.  
2.28.  Most jurisdictions , including the EU and Korea, do not require safety tests as part of energy 
efficiency tests. Indeed, the aforementioned requirements in India are excessive compared to the 
relevant ones in other countries. In addition, it is known that the BIS (Bureau of Indian Stand ards) 
also received comments regarding the mandatory implementation of IS 302 -2-7 certification for 
washing machines in December 2022. If the corresponding BIS QCO (Quality Control Order) enter 
into force, it will be a duplicated regulation by the BEE and the BIS for the same standard, which 
 
7 For previous statements follow the thread under ID 785 . G/TBT/M/89  
 
- 11 - 
 
  would impose an excessive burden on the related industries. As such, Korea would like to request 
the removal of the safety test requirements specified in the amendment to the energy efficiency 
regulation for washing mac hines by BEE.  
2.29.  Secondly , although the regulation stipulates that a washing program designated by the BEE 
shall be used when conducting energy efficiency tests for washing machines, however, when testing 
is conducted by a third -party testing institute, the m anufacturer is guided to designate the washing 
program for testing, causing confusion in the test process. For reference, the related international 
standard, IEC 60456, specifies that manufacturers can designate washing programs for testing. 
Therefore, we would like to request that India clarify the relevant test procedure and amend the 
regulation to allow manufacturers to designate washing programs. Third, it will be quite an excessive 
measure to regulate the energy efficiency of the Mini Washer product, w hich is an auxiliary product 
that cannot be operated alone. So we would like to request that such Mini Washer products be 
excluded from the regulatory scope. Finally, this regulation is scheduled to become mandatory on 
1 July 2023. However, it has not been  notified to the WTO, and above all, the final text of the 
amendment has not been announced yet. For this reason and under Articles 2.9.2 and 2.9.4 of the 
WTO TBT Agreement, Korea requests that, apart from collecting domestic opinions, India notify 
other W TO Members through the WTO Secretariat, receive comments and take them into account 
before finalizing the amendment and publish it with a sufficient grace period for regulatory 
compliance.  
2.30.  In response , the representative of India provided the following statement. The QCO for 
Washing Machines is not being implemented presently, BEE with due diligence and consensus of all 
the technical committee members, decided to get the product tested for safety requirements. For 
washing performa nce and energy consumption tests, India labelling program is totally in line with 
IEC 60456 and it is the manufacturers who has to declare their washing program to the testing 
authority. Therefore, it is evident that India labelling program has made no dev iation in the test 
procedure in respect of the above tests. Both IEC 60456 and IEC 60335 -2-7 are silent about Mini 
Washer in their scope. In accordance with the provisions of the said standards, no differentiation 
has been laid down for Mini Washer and the  conventional washing machine. India's Standards and 
Labelling Program for Washing Machines covers both semiautomatic and fully automatic (top and 
front loading).  
2.1.2.5   European Union - Proposal for a Regulation on packaging and packaging waste 
amending Regulati on (EU) 2019/1020 and Directive (EU) 2019/904, and repealing 
Directive 94/62/EC (ID 7868) 
2.31.  The representative  of the Russian Federation  provided the following statement. Russia 
supports efforts taken to fight climate changes and to protect the environment.  At the same time, 
such measures shall be consistent with WTO rules and shall not lead to unnecessary additional 
obstacles to trade. Today, Russia would like to express a concern related to the proposal of a draft 
Regulation on Packaging and Packaging Wast e published in November 2022. We took note of the 
presentation made yesterday on the draft regulation. It clarified some questions. Nevertheless, in 
our view, the proposed regulation does not take into account the specifics of the market, as well as 
the le vel of development of waste management in the world. It is also not consistent with WTO rules. 
In this regard I would like to make several points. First, we note inconsistency of terminology used 
in the draft regulation with the relevant international stan dards. For example, the definition of 
"packaging" in the draft regulation includes not only the product itself, but also the material and 
various additional elements from which the "packaging" is produced. The definition of "packaging" 
diverts significantl y from the one specified in international standards, in particular: ISO 21067 -
1:2016, ISO 21067 -2:2015.  
2.32.  Second, there is inconsistency with international standards of the draft regulation's 
requirements that goes beyond terminology. In particular, there ar e significant differences in the 
attribution of certain products to packaging. For example, the draft Regulation refers flowerpots to 
packaging for transportation or sale only. It is obvious that in practice it is hardly possible to separate 
such pots acco rding to their intended purpose. The list of packaging also includes clothes hangers, 
which are not included in the packaging according to international standards. The proposed 
measures regarding packaging that must be recycled also differ from those speci fied in international 
 
8 For previous statements follow the thread under ID 786 . G/TBT/M/89  
 
- 12 - 
 
  ISO standards, in particular with the ISO 18600 series of standards "Packaging and the 
environment".  
2.33.  Third, Articles  43 and 47 of the draft Regulation contain the term "high" and "medium" quality 
recycling, however, the document does not provide any definition of what should be understood by 
a "high" or "medium" level of recycling, nor provided any reference to the rela tive international 
standard. It is not clear, who and how will determine the "high" and "medium" quality recycling if 
such measure is introduced. Finally, the draft regulation seeks to establish requirements for 
recyclability and for the share of recycled material in packaging. Although it is technically possible 
to manufacture certain types of packaging from recycled materials, for most types of packaging 
there are no approved in international level test methods confirming the safety of using recycled 
materials and the preservation of packaging functions.  
2.34.  Moreover, there is no scientific evidence for the requirements to be imposed. The EU did not 
provide grounded justifications as to why certain requirements would apply to the products covered. 
It seems tha t the EU has decided to develop its legislation based on private standards applied by 
the enterprises consuming packages rather than on the rules, principles and procedures stipulated 
by the Agreement on TBT. To sum up, the proposed draft regulation seems to be inconsistent with 
WTO rules, in particular with Article 2 of the TBT Agreement as its measures are not based on 
international standards and may create significant uncertainty in the EU market, as well as 
unnecessary obstacles to international trade. In this regard, the Russian Federation requests that 
international standards used as a basis for the proposed Regulation or a relevant specific scientific 
justification is disclosed. We also urge the EU consider comments provided today by WTO Members 
and take them into account during further work on the draft regulation.  
2.35.  The representative  of China  provided the following statement. China appreciates the efforts 
made by the EU in reducing the quantity of packaging waste, promoting high -quality recycling of 
packaging ("closed -loop"), and reducing the demand for primary natural resources, and thanks the 
EU for the timely release of the PPWR proposal. The revised PPWR will have wide application and 
cover a large range of products. It specifies a number of requir ements on packaging, such as 
solutions for packing that can be reused and refilled, making all packaging on the EU market 
recyclable in an economically feasible way by 2030 and creating a well -functioning market for 
secondary raw materials (regenerated mat erials), increasing the use of recycled plastics in packaging 
through mandatory proportion of recycled materials. All these requirements will have long -term and 
far-reaching impacts on the packaging industry and a significant influence on the trade of rela ted 
products to Europe. In view of this, we would like to request that the EU continue its good practice 
on transparency, inform Members of the progress of the proposal in a timely manner, give Members 
opportunities to put forward their comments and sugges tions on the PPWR, and provide an 
appropriate transition period, and facilitate the trade while aiming to protect the environment.  
2.36.  In response , the representative of the European Union  provided the following statement. The 
EU would like to inform WTO Membe rs that the proposal was notified under the TBT Agreement on 
27 February 2023. The final date for comments is 90 days from the notification. The proposed date 
of adoption is 2025. The EU would welcome written comments from other WTO Members within the 
specified deadline and we will reply to these comments under the procedure.  
2.1.2.6   United States - Chapter 173 -337 of WAC, safer products restriction and reporting, 
G/TBT/N/USA/1958  (ID 7879) 
2.37.  The representative  of China  provided the following statement. Chi na thanks the United States 
for its notification of Chapter 173 -337 of WAC, safer products restriction and reporting, regarding 
which China would like to raise the following concerns. First, China requests the US not to control 
OFRs as a whole but instead to specify certain OFR subgroups to be restricted based on 
comprehensive assessments, including scientific hazard assessment, technical feasibility of 
alternatives as well as impacts on the industry. There is a total of over 100 types of OFRs, and no 
more than 10 types are restricted currently. US National Academies of Sciences, Engineering, and 
Medicine (NASEM) released a study report in 2019, pointing out that OFRs used in consumer products 
cannot be classified  as a single group  through hazardous assessme nt; instead they should be sorted 
into 14 subgroups based on chemical structure, physico -chemical properties, and predicted biologic 
activity, and then the assessment should be based not only on hazard but also technical feasibility 
 
9 For previous statements follow the thread  under ID 787 . G/TBT/M/89  
 
- 13 - 
 
  of alternatives, as wel l as impacts on the industry. Thus, to avoid unnecessary barriers to trade, it 
is not desirable to conduct "one size fits all" control over OFRs without sufficient scientific 
assessment; instead, subgroup -based control should be adopted.  
2.38.  Second , China requests that the US should grant exemption to those EEE products which do 
not have alternatives to OFRs temporarily. Restricting the use of OFRs is aimed to achieve "Safer 
Products". Although in some instances there might be alternatives to some s ub-groups of OFRs for 
use in indoor EEE casings, however, alternatives are not always available for all occasions. If product 
manufacturers are forced to use alternatives not well proven, it will undermine the fireproof 
performance of the indoor EEE produc ts and jeopardize consumers' life and property. Besides, from 
the perspective of circular economy, plastics with OFRs actually have their unique advantage in 
recycling and carbon footprint, given their comparatively high thermal stability. Thus it is sugge sted 
that US should grant exemption to those EEE products which do not have alternatives to OFRs 
temporarily. Third, China suggests that the US should specify the names of toxic chemicals and the 
scope of EEE products. On one hand, the proposed rule should  specify individual electronic and 
electrical products that it plans to regulate, and on the other hand, it should specify individual OFRs 
by CAS Registry Number that it plans to regulate. This information is needed to alleviate confusion 
and avoid potenti al supply chain disruptions that could harm the supply of EEE products in 
Washington State.  
2.39.  The representative  of Japan  provided the following statement. Japan shares the following 
concerns regarding the proposed restrictions on organohalogen flame retarda nts (OFRs) in external 
plastic enclosures of consumer electrical and electronic equipment (EEE) (hereinafter referred to as 
"Proposed OFR restrictions") for an implementation program (known as "Safer Products for 
Washington") of Chapter 70 A. 350 RCW, US -State of Washington Law. Consumer EEE is used in a 
wide range of fields, including consumer electronics, medical equipment, and telecommunications 
equipment. OFR does not mean a single substance, but a group of all organohalogen flame 
retardants, whose numb er is said to be in the tens of thousands or more. Since OFRs are commonly 
used in EEE plastic external enclosures to prevent the ignition and spread of fires in case of a fire, 
resulting in protecting human lives, if this Proposed OFR restrictions would b e implemented in an 
early manner, not only would many industries be seriously affected, but also many citizens in the 
United States would be at a huge disadvantage because of no distribution of consumer EEE. 
Therefore, very careful consideration is necessa ry before this Proposed OFR restriction is 
implemented.  
2.40.  The laws and regulations of other States in the United States, other countries or regions as 
well as international conventions do not restrict all OFRs uniformly for all consumer EEE plastic 
external enclosures. For this Proposed OFR restrictions, the Department of Ecology, the State of 
Washington (hereinafter referred to as "the DoE") has merely conducted research on only 22 OFRs 
that are thought to be potentially hazardous, and it does not seem to be  proven that all OFRs are 
potentially hazardous. We would appreciate if the DoE could provide evidence for concluding that all 
OFRs are hazardous. In addition, although the DoE has asserted that several non -halogen flame 
retardants are available as alterna tives to OFRs, it will take time for industry to confirm that those 
alternatives can be used with equivalent properties and safety profiles for all types of consumer EEE 
plastic external enclosures.  
2.41.  We understand  that the objective of the Safer Products fo r Washington is to protect citizens 
from exposure to hazardous chemicals. However, we have been informed by Japan industrial 
associations that there is little release of OFRs from consumer EEE during its use and it is considered 
that the risk of adverse ef fect on human health and the environment is extremely low. Therefore, 
implementing the Proposed OFR restrictions at an early time would simply force EEE manufacturers 
to cancel shipments of non -conforming products to the United States, and would significan tly affect 
trade and distribution of many aforementioned EEE to the United States. We have been informed by 
Japan industrial associations that they submitted comments to the DoE during three public comment 
periods in relation to the concerns stated above. However, we have been informed that few of their 
requests have been reflected in the Proposed OFR restrictions to date and they also submitted similar 
comments to its TBT notification. Japan understands that the objectives of the regulations are 
protection  of human health and the environment. However, Japan is concerned that the regulations 
would be more trade -restrictive than necessary to fulfill the objectives and in violation of Article 2.2 
of the TBT Agreement. For the reasons stated above, in order to ensure that the proposed OFR 
restrictions are not more trade -restrictive than necessary to achieve its legitimate objectives, Japan 
would like to request the United States as follows: to conduct a more thorough risk assessment G/TBT/M/89  
 
- 14 - 
 
  regarding the impact on human  health and the environment posed by OFRs contained in EEE plastic 
external enclosures, taking into account the consistency with the results of risk assessment in other 
countries and regions; to narrow the range of the OFRs and the type of EEE to be regula ted, and set 
appropriate and feasible thresholds for OFR content; and to conduct a realistic feasibility study on 
the alternatives and to consider a more appropriate schedule until the implementation of the OFR 
restrictions.  
2.42.  In response, the representative  of the United States  provided the following statement. On 
6 January 2023, the United States notified Washington State's Administrative Code for safer 
products restrictions and reporting. This measure creates reporting requirements or restrictions that 
apply to consumer products for certain chemicals. The United States appreciates the comments 
submitted by China, Japan and Korea in response to this notification and will take into consideration 
all comments received during the open comment period and respond  to substantive comments in 
the next published rulemaking procedure.  
2.1.2.7   China - Electrical Safety Regulation for Medical Electrical Equipment, 
G/TBT/N/CHN/1410  (ID 78810) 
2.43.  The representative  of Japan  provided the following statement. Japan raises the following 
concerns regarding the National Standard GB9706.1 -2020, and collateral standards. The National 
Standard for Electrical Safety of Active Medical Devices GB9706.1 -2020 was revised on 9 April 2020, 
and its collateral standards have also been revised . All medical devices are required to complete 
conformity certification to the revised standard by medical device inspection centres and registration 
change of medical devices according to the Regulations for the Supervision and Administration of 
Medical D evices by 1 May 2023. However, it usually takes more than one year to complete the 
registration change under the Regulations after completing the conformity certification. Considering 
that the inspection centres started accepting application for conformity  certification under the revised 
standard after January 2023 in some regions, the transition period required for the certification 
procedures is not sufficient.  
2.44.   In addition to conforming to the GB9706.1 -2020, some medical devices have to meet further 
particular standards that are specific to the medical devices. These particular standards are currently 
being revised in compliance with the GB9706.1 -2020. For example, some particular standards, such 
as those related to Patient Monitors and Defibrillators, ha ve just been revised after the end of 2022, 
while others, such as those related to Thermometry, have not been revised yet. However, in order 
to certify conformity to the GB9706.1 -2020, it is necessary to conform to these particular standards 
after their re vision. Therefore, medical devices that have to meet their particular standards need to 
be redesigned after the publication of the revised particular standards, obtain conformity certification 
to the revised GB9706.1 -2020 with its collateral standards and related particular standards by 
medical device inspection centres, and complete the registration change of the medical devices, but 
the transition period required for these procedures is not sufficiently secured.  
2.45.  As Japan mentioned , there is concern that C hina's measures would be in violation of 
Article  2.12 of the TBT Agreement because the interval between the publication of the National 
Standard GB9706.1 -2020, collateral standards and particular standards and their entry into force in 
order for manufactur ers to adapt their medical devices to the requirements of the National Standard 
GB9706.1 -2020, etc., is inappropriate. Japan is deeply concerned that many manufacturers will not 
be able to complete the GB9706.1 -2020 conformity certification and registratio n change of medical 
devices by the transition deadline. Japan is also very concerned that this will cause significant 
disruption to the supply of many active medical devices needed for healthcare in China. Therefore, 
Japan would like to request extension o f the transition period as follows. The transition period of the 
GB9706.1 -2020 and its collateral standards shall be postponed for three years from the current 
implementation date. Or, as was the case when the GB9706.1 was revised in 2007, even if 
registra tion change of medical devices based on this revised National Standard GB9706.1 -2020 has 
not been completed as of 1 May 2023, these medical devices shall be allowed to be sold until the 
expiration date of the medical device registration based on the previo us National Standard before 
its revision.  
2.46.  The representative  of the United States  provided the following statement. The United States 
has interest in this STC and thanks Japan for adding it to the agenda. We are still reviewing the 
 
10 For previous statements follow the thread under ID 788 . G/TBT/M/89  
 
- 15 - 
 
  concerns raised by Japan  along with investigating the specific concerns filed by the medical devices 
industry and look forward to any additional information and updates from China that they are able 
to provide. We note the US industry has requested China to provide a three -year e xtension until 
May 2026 before this technical regulation enters into force due to the large number of products 
subject to the regulation as well as the insufficient laboratory testing capacity.  
2.47.  In response, the representative  of China  provided the followi ng statement. GB 9706.1 -2020 
"Medical Electrical Equipment Part 1: General Requirements for Basic safety and Essential 
performance" was released on 9 April 2020, and will be implemented from 1 May 2023. Its 
supporting parallel standards have also been rele ased, with special standards currently under 
preparation. The implementation of GB 9706.1 -2020 series standards is of great significance to the 
overall improvement of the quality and safety level of China's active medical devices. National 
Medical Products  Administration will issue documents to guide the orderly implementation of the 
standards.  
2.1.2.8   European Union - Draft Commission Delegated Regulation amending Regulation 
No. 1272/2008 as regards hazard classes and criteria for the classification, labeling and 
packaging of substances and mixtures, G/TBT/N/EU/926  (ID 78911) 
2.48.  The representative  of China  provided the following statement. China would like to thank the 
EU for its notification of the Draft Commission Delegated Regulation amending Regulation No. 
1272/2008 as regards hazard classes and cr iteria for the classification, labelling, and packaging of 
substances and mixtures. In line with Article 2.2 of the WTO/TBT Agreement, China would like to 
invite the EU to, first, give a list and a corresponding exemptions list of substances and mixtures 
with "endocrine disrupting property for human health" and "endocrine disrupting property for the 
environment", provide further testing and verification methods for "endocrine disrupting property 
for human health" and "endocrine disrupting property for the e nvironment", thus enabling 
stakeholders to determine whether a substance or mixture belongs to the two new categories of 
endocrine disruptors, and avoiding unnecessary trade barriers; second, develop a hazard class of 
PMT (Persistent, Transportable, Toxic) . Previously, the hazard classification in the EU was PBT 
(persistent, bioaccumulative and toxic ). B in PBT refers to being bioaccumulative. If a substance is 
highly bioaccumulative, it is also highly enriched in soil and difficult to migrate. However, M in the 
PMT developed by the EU this time emphasizes mobility, so B in the PBT and M in the PMT are 
contradictory, which is easy to cause ambiguity in the regulation implementation. China hopes that 
the EU provides the scientific basis for the classificatio n of PMT, or clarify the contradiction between 
B as in PBT and M as in PMT; and third, give a model for the calculation of the M, to facilitate the 
experimental verification and as a result avoiding unnecessary obstacles to international trade.  
2.49.  Besides, g iven that the application time of the regulation is too short, which is likely to lead 
to the failure of the regulation's  implementation, China requests the EU to extend the application 
time of new substances to 36 months, referencing the time allowed for product experiment cycle 
and assessment after the official implementation of the 2018 EU Guidelines on the identification of 
endocrine disruptors for pesticides and disinfection and sterilization Products.  
2.50.  In response , the representative of the European Un ion provided the following statement. The 
European Union thanks the People's Republic of China for its interest in the Regulation adopted by 
the EU Commission on the introduction of new hazard classes for endocrine disruptors for human 
health and environme ntal hazards (endocrine disruptors, PBT, vPvB, PMT and vPvM)12. It should be 
published soon. The new hazard classes and criteria are the result of in -depth scientific discussions 
with experts from EU Members and stakeholder representatives. In parallel wit h its adoption at EU 
level, the EU is co -ordinating the discussions on the inclusion of these hazards in the started Globally 
Harmonized System of Classification and Labelling of Chemicals (GHS) in the framework of the 
United Nations. The EU very much hope s that it can count on the People's Republic of China's support 
to address the growing concerns of citizens and scientists on endocrine disrupting chemicals and 
those with long lasting effects in the environment.  
 
11 For previous statements follow the thread under ID 789 . 
12 PBT stands for Persistent, Bioaccumulative and Toxic properties, vPvB stands for very Persistent and 
very Bioaccumulative properties, PMT stands for Persistent, Mobile and Toxic properties, vPvM stands for very 
Persistent and very Mobile properties.  G/TBT/M/89  
 
- 16 - 
 
  2.51.  Regarding endocrine  disruptors and PBT/vPvB  criteria, the EU largely builds on existing criteria 
in other EU legislation as REACH, the Plant Protection Products Regulation and the Biocidal Products 
Regulation. Only the PMT and vPvM criteria are really new. Guidance is under development and will 
cover all new hazard classes. It will be available before the end of the transitional period of 24 
months in order to ensure that suppliers would be able to assess if their substances or mixtures fulfil 
the criteria for classification as an endocrine disrupto r for human health or the environment. This 
guidance will also list all test methods, including in vitro  ones, that could be used to classify 
substances as endocrine disruptors. The new hazard classes will be included in Annex I to CLP, 
together with the o ther hazard classes and criteria. Based on these criteria and for some prioritised 
substances, the EU will develop harmonized classification and labelling dossiers and companies will 
have to classify their substances and mixtures according to the new crite ria. The list of substances 
China refers to is presumably the Table with the harmonized classification and labelling entries in 
Annex VI to CLP. Substances are included there after a long and thorough scientific process, hence 
the EU would not be able to p rovide such list until that has been achieved.  
2.52.  As to the concerns  raised regarding the scientific basis for classification as PMT and more 
specifically the claim that the P and M criteria would contradict each other, please note that we do 
not see any cont radiction between P and M properties. To the contrary they are complementary. 
Mobility does not mean that a substance disappears, but that it migrates, hence it can be mobile 
and persistent at the same time. In addition, the criterion for persistency is no t limited to the soil 
compartment, but covers the aquatic compartment as well. Both criteria need to be fulfilled 
cumulatively to warrant classification as PMT, in addition to being toxic. If a substance is toxic and 
only mobile or only persistent, it woul d not be classified as PMT. As to the calculation method for 
mobility, please note that the log KoC criterion which is one of the elements to be taken into account 
as part of an overall assessment weighing all available evidence and using expert judgment. It would 
not exclude taking into account e.g. results of leachability and monitoring studies relevant to identify 
M/vM substances. The guidance will provide explanation on how to use additional information to log 
Koc to assess mobility of substances. With regard to the application time for substances not yet 
placed on the market, please note that the text has been revised and extended to 24 months. For 
substances already on the market, the deadline remains 42 months. Those transitional provisions 
should all ow suppliers sufficient time to adapt to the new rules. The EU reiterates its commitment 
to act in full transparency and keep Members duly informed about further developments.  
2.1.2.9   India - Viscose Staple Fibres (Quality Control) Order, 2022, G/TBT/N/IND/234  
(ID 79013) 
2.53.  The representative  of Indonesia  provided the following statement. Indonesia thanks India for 
notifying G/TBT/N/IND/234  on Viscose Staple Fibres (Quality Control) Order to the TBT WTO 
Committee on 1 September 2022. Referring to the notification, the regulation requires Viscose St aple 
Fibre (VSF) products to comply with the requirements set out in the Indian standard IS 17266:2019 
Textiles -Viscose Staple Fibres -Specification, with compliance being achieved through certification by 
BIS. In addition, VSF is also required to carry the  ISI mark as proof of compliance prior to distribution 
in the Indian market. Indonesia appreciates that India has suspended the enforcement of this 
regulation until 29 March 2023, as announced in the Gazette of India dated 27 January 2023. 
However, we enco urage India to submit the addendum to notification G/TBT/N/IND/234  on this 
measure in order to inform stakeholders on the implementation status of this regulation. Indonesia 
would like India to consider further suspending the implementation of the Q CO. We believe that the 
transition period provided by India is still insufficient for companies to comply with the requirements 
of this regulation. The certification process conducted by BIS may also take some time. Therefore, 
we request India to postpone the implementation of the VSF QCO until 29 February 2024, or provide 
a 12-month transition period.  
2.54.  Indonesia  also requests India to consider the option of international recognition under the 
MRA/MLA framework for conformity assessment results and/or confor mity assessment bodies from 
the country of origin. This will speed up the certification process, avoid duplication of testing and 
certification procedures, and may reduce the cost of conformity assessment.  
2.55.  The representative  of the European Union  provided the following statement. Let me begin by 
making several remarks that horizontally apply to all Quality Control Orders raised at this meeting 
of the TBT Committee and to other (draft) QCOs. The EU remains deeply concerned by the increasing 
 
13 For pre vious statements follow the thread under ID 790 . G/TBT/M/89  
 
- 17 - 
 
  number of Quality  Control Orders (QCOs) issued by India across many sectors. The EU would like to 
recall that the majority of QCOs introduced by India appear to have a protectionist orientation and 
consequently raise questions regarding their compliance with the WTO's TBT Agreement obligations. 
The EU is particularly concerned by the fact that QCOs usually prescribe India -specific standards 
where international standards already exist. The EU would like to remind India that Article 2.4 of the 
WTO TBT Agreement requires Membe rs to use international standards, where they exist, as basis 
for their technical regulations, except, when such international standards or relevant parts would be 
an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursue d, for 
instance because of fundamental climatic or geographical factors or fundamental technological 
problems.  
2.56.  Furthermore , QCOs prescribe mandatory conformity assessment procedures that are more 
restrictive than necessary to fulfil their legitimate object ive. They cause extra burden and economic 
cost to the EU industry as a result of unnecessarily cumbersome procedures, including mandatory 
factory inspections, sample testing in Indian laboratories, to obtain necessary permissions or licences 
for products a lready tested and certified under established international standards and schemes. 
There is no provision for a streamlined process on the basis of existing certification from any 
international body. The EU is concerned with the visible trend towards establ ishing mandatory 
domestic standards in India that deviate from international ones for growing number of products in 
textile sector. The EU also noticed that India is failing to notify many of these measures as required 
under Articles 2.9 and 5.6 of the WTO  TBT Agreement.  
2.57.  The EU would like to seek clarifications from India, explaining the reasons for establishing 
India-specific QCO for Viscose Staple Fibres when EU exports already comply with internationally 
recognized standards like ISO. The Viscose Staple Fibres QCO, same as other QCOs, is based on a 
registration process with the Bureau of Indian Standards (BIS). Manufacturing facilities in the 
exporting country must be audited in person by a team of BIS officials. The EU is deeply concerned 
not only about the significant cost of such registration but also by the requirement to reveal 
commercially sensitive information regarding pricing and production, as well as a requirement to 
make a USD 10,000 bank guarantee in favour of BIS which is held as a "quality p erformance 
guarantee". The proposed measures for Viscose Staple Fibres require products to be tested twice, 
including local audits and designated laboratory tests. This represents additional burden to the EU 
industry related to registration, bank guarantee , testing and certification. The products covered by 
this legislation do not present risk to health and safety, as they are subject to a detailed testing for 
safety and quality control in the EU before being exported. For this reason, the mandatory 
certifi cation by the BIS is considered as unnecessary.  
2.58.  The QCO in question  is not in line with Article 2.2 of the TBT Agreement, which states that 
Members shall ensure that technical regulations are not prepared, adopted or applied with a view 
to, or with the eff ect of, creating unnecessary obstacles to international trade. Furthermore, as a 
bank guarantee is required for all imported products, the QCO appears to run against Article 2.1 of 
the TBT Agreement, according to which Members shall ensure that in respect of technical regulations, 
products imported from the territory of any Member shall be accorded treatment no less favourable 
than that accorded to like products of national origin and to like products originating in any other 
country. It is worth recalling that EU -based producers of man -made fibres already comply with a 
wide range of quality, safety, and environmental protection related certifications and standards, such 
as ISO 9001, 14001, and 45001, EU Ecolabel and European Pharmacopoeia.  
2.59.  The EU would  like to ask India to re -consider the current standards and conformity 
assessment procedures set in this QCO and to consider aligning the BIS standards and conformity 
assessment procedures with international standards and approaches, as well as to accept certif icates 
issued outside India based on ISO standards. The EU would also like to point out that compulsory 
process of affixing the ISI mark is redundant and results in excessive certification costs, while strict 
packaging requirements constrain innovation and  even limit the use of more environmentally friendly 
materials. In addition, the EU would also like to request India if it would be possible to clarify the 
scope of Quality Control Orders by indicating in the legal act the HS code(s) of the goods concerned . 
Finally, the EU would like to ask India to consider deferring the implementation of this QCO, originally 
planned for 29 March 2023. Article 2.12 of the WTO TBT Agreements requires a reasonable interval 
between the publication of technical regulations and  their entry into force in order to allow time for 
producers to adapt their products or methods of production to the new requirements. The EU would 
also like to recall that according to the 2001 WTO Ministerial Decision on Implementation -related 
Issues and  Concerns, Ministers agreed that the phrase "reasonable interval" shall be understood to G/TBT/M/89  
 
- 18 - 
 
  mean normally a period of not less than six months, except when this would be ineffective in fulfilling 
the legitimate objectives pursued.  
2.60.  In response , the representat ive of India provided the following statement. We thank the 
delegations of European Union and Indonesia for their interest in this issue. We are currently 
examining the statements made. We will provide a response after due examination of the issues 
raised.  
2.1.2.10   India - Energy Consumption Standards for Star Labelled Household 
Refrigerators, S.O. 4554(E), 2022 (ID 79114) 
2.61.  The representative  of the Republic of Korea  provided the following statement. Korea respects 
India's efforts to introduce new energy efficiency r ating standards for household refrigerators, and 
Korean industries are making efforts to comply with Indian regulations. In relation to "Amendment 
Notification of Energy Consumption Standards for Star Labelled Household Refrigerators (Statutory 
Order 4554( E).)," published in the Indian Official e -Gazette on 26 September 2022, Korea submitted 
comments regarding concerns raised by the Korean industry through the TBT Enquiry Point on 
12 October 2022. However, as we have thus far not received any reply from Ind ia on this matter, 
we would like to convey our comments again as follows. If a correction factor is not applied to the 
formula for calculating the internal volume of the freezer compartment, which consumes more power 
than the refrigerator compartment, the products with larger freezer compartments, such as side -
by-side or four -door refrigerators, will have more disadvantages when it comes to estimating the 
energy efficiency rating. This amendment does not conform to the international standard IEC 62552 -
3 and  deviates from the general and international practice used in the EU, the US, and Korea, in 
which the efficiency rating of refrigerators is estimated by weighting the internal volume of the 
freezer compartment.  
2.62.  For this reason , Korea requests that the "Adj usted Volume" be applied, which assigns a freezer 
compartment weight factor to the energy efficiency rating calculation formula for refrigerating 
appliances, in line with international standards, so that a variety of products can be provided to the 
Indian market. In addition, the amended regulation has not been notified to the WTO Members 
through the WTO Secretariat, despite the fact that it is not in accordance with the relevant 
international standards and may have a significant effect on the trade of othe r WTO Members. 
Accordingly, pursuant to Article 2.9.2 of the TBT Agreement, Korea requests that India notify the 
WTO Members of the amendment.  
2.63.  In response, the representative of India provided the following statement. We thank Korea 
for their interest in this issue. Calculation of volume of freezer compartment is based on the Indian 
Standard 17550 published by BIS. The development process of Star Rating program involves 
consultation with the Technical Committee members which includes various stakeholders viz. 
manufacturers, testing labs, accreditation body, standard making body, consumer voice and 
associations etc. Further, S.O. 4554 (E) published on 26 September 2022 covers Single Door and 
Double Door Refrigerators (i.e. Frost Free and Direct Cool Refrigerator ). The Side -by-Side and multi 
door refrigerators are not covered under the scope of aforesaid Gazette Notification. Recently, BEE 
has prepared and launched the Star Rating Program for Side -by-Side/Multi Door Refrigerator under 
Voluntary regime whose energy  consumption standards are different. The revised star rating table 
for Refrigerator implemented with effect from 1 January 2023 along with volume calculation formula 
was presented to the Technical Committee Members which is based on BIS new standard - 17550. 
The same was finalized during 8th Technical Committee Meeting held on 8 July 2022 based on the 
agreement of Technical Committee members. Hence, sufficient time was provided after introduction 
of the revised star rating program for Refrigerator.  
2.64.  Also, m any overseas manufacturers are members of the Technical Committee and the new 
energy performance  standards are agreed by all the members of the Technical Committee. Further, 
it is reported that all the manufacturers have already registered their models wit h Bureau of Energy 
Efficiency as per the new energy performance standards for refrigerator. So far, 450+ models are 
registered with Bureau of Energy Efficiency based on the revised star rating table implemented from 
1 January 2023.  
 
14 For previous statements follow the thread under ID 791 . G/TBT/M/89  
 
- 19 - 
 
  2.1.2.11   European Union - Amendme nt of the authorisation for the active substance 
sulfoxaflor, G/TBT/N/EU/853  (ID 79215) 
2.65.  The representative of Brazil  provided the following statement. Brazil thanks the European 
Union for the opportunity to comment on the proposition notified as G/TBT/N/EU/853 , which aims 
at restricting the conditions  of approval of the active substance sulfoxaflor to uses in permanent 
greenhouses only in order to protect bees. Brazil has submitted comments on this proposition and 
is looking forward to receiving replies from the EU. Sulfoxaflor is a priority crop protection tool used 
by Brazilian growers of orange. This industry plays an important role in generating jobs in the 
countryside, and exports of orange juices to the European market represented more than USD 1.1 
billion in 2022. Sulfoxaflor is used to control pests such as the citrus psyllid, an insect that transmits 
the greening disease. Recognized by the European Food Safety Agency (EFSA) as a priority pest for 
control in EFSA's List of Priority Pests of  October 2019, greening is a major cause of losses in orange 
production not only in Brazil, but worldwide.  
2.66.  Considering  these circumstances, Brazil would like to know if the stricter conditions of 
approval of sulfoxaflor in the EU, as proposed, would lead t o reducing MRLs of this substance on 
imported products. If so, a solid risk analysis, consistent with the Codex Alimentarius' 
recommendations, will be important to ensure transparency and predictability in the regulatory 
process. Brazil is concerned, furth ermore, that, as in other cases, the EU would seek to avoid a 
supposed transfer of adverse effects on bees from food production in the EU to food production in 
non-EU countries. In this case, regulators should consider the variety of local conditions, incl uding 
climate, soil and the different needs and challenges posed by agricultural production in each country. 
In Brazil, the use of sulfoxaflor has been approved by relevant authorities after rigid technical 
procedures, including an assessment by the Brazil ian Institute for the Environment that considered 
the effects of the substance in bees.  
2.67.  Brazil believes, moreover, that reductions of MRLs on such basis go against the commitment 
in Article 2.2 of the TBT Agreement, as it is out of the scope of such Agreem ent to support unilateral 
policies aimed at supposedly protecting the environment in third countries. We understand that, as 
they have extraterritorial effects, such measures go against the rules and jurisprudence of the 
multilateral trade system. Brazil w ould highly appreciate if the EU could provide further clarifications 
on the proposed measure and take these comments into consideration in the regulatory process. 
Thank you.  
2.68.  The representative  of Argentina  provided the following statement. Argentina suppo rts Brazil's 
approach and in this regard would also like to know whether the stricter conditions for the approval 
of sulfoxaflor in the EU would lead to the reduction of MRLs for this substance in imported products. 
If so, Argentina considers that it will be important for the EU to conduct a robust risk analysis, 
consistent with international recommendations, to ensure transparency and predictability in the 
regulatory process. Argentina also shares Brazil's concern that, as in other cases, the EU is seeking  
to avoid an alleged transfer of adverse effects on bees involved in EU food production due to the 
importation of food from third markets outside the EU. In Argentina, this substance is used in 
extensive crops as well as fruit (pears and apples), which inc lude relevant productive sectors in 
different regions of the country. We emphasize that European regulators should consider the variety 
of local conditions in other countries, including climate, soil and the different needs and challenges 
of agricultural p roduction in each country.  
2.69.  We also share Brazil's approach that MRL reductions on this basis are contrary to the 
commitment of Article 2.2 of the TBT Agreement, as it is outside the scope of this Agreement to 
support unilateral policies aimed at allegedly protecting the environment in third countries. We 
understand that, by having extraterritorial effects, such measures are contrary to the rules and 
jurisprudence of the multilateral trading system, and we insist that these measures are not based 
on a robust  environmental impact assessment, which is what is required to decide whether it is 
neonicotinoids that are affecting the bee population or the severe climate crisis that we are 
experiencing, particularly when it is clear that these are phenomena with mult iple causes.  
2.70.  In response, the representative of the European Union  provided the following statement. The 
EU notified the draft Commission Implementing Regulation amending the conditions of approval of 
the active substance sulfoxaflor on 17 November 2021 ( G/TBT/N/EU/853) , based on the evaluation 
 
15 For previous statements follow the thread under ID 792 . G/TBT/M/89  
 
- 20 - 
 
  of confirmatory data, as required in Regulation (EU) 2015/1295 approving its use in the EU. TBT 
comments were admissible until 17 January 2022. On 28 April 2022 the European Commission 
adopted the Commission I mplementing Regulation (EU) 2022/686 restricting the use of sulfoxaflor 
to indoor uses only. The conclusion is based on a risk assessment (peer -reviewed at EU level under 
the lead of the European Food Safety Authority -EFSA), which concluded risk to bees is  low when 
plant protection products containing sulfoxaflor are used in permanent greenhouses. The measure 
therefore aims at restricting the conditions of approval of the active substance sulfoxaflor to uses 
only inside permanent greenhouses, in order to pr otect bees.  
2.71.  In line with Article  3 of the Regulation 2022/686, EU member States had to withdraw, where 
necessary, or amend, by 19 November 2022 at the latest, authorizations for plant protection 
products containing sulfoxaflor as an active substance. Furthermore, according to Article 4 a ny grace 
period granted by EU member States (in accordance with Article 46 of Regulation (EC) No 1107/2009 
for marketing and use of existing stocks) shall expire by 19 May 2023 at the latest. The EU would 
like to re -assure Brazil, Argentina, and all other interested Members, that the measure does not lead 
to any immediate disruptions of trade in agricultural goods, as it does not amend MRLs. Separate 
action will likely be taken on MRLs, following the expiry of all grace periods for stocks, and a separate 
notification will be submitted to the SPS Committee.  
2.1.2.12   Malaysia - Revision of the Regulations on Alcoholic Beverages in Food 
Regulations 1985, G/TBT/N/MYS/114  (ID 79316) 
2.72.  The representative  of the European Union  provided the following statement. The European 
Union would like to thank Malaysia for the notification G/TBT/N/MYS/114  of 27 October 2022 on 
amendment to Regulations 361 to 368A and 387 and insertion of a new Regulation 384A to Food 
Regulations 19 85. The EU provided its comments on these legislative amendments in December and 
Malaysia replied at the end of January 2023, for which we would also like to thank Malaysian 
authorities. Nevertheless, having thoroughly studied Malaysian replies, we still w ould like to ask 
Malaysia for concrete information concerning several issues the EU had raised in its comments. In 
particular, we are interested to know more on alcoholic range and on permitted preservatives and 
food conditioners for wine and on definition  of liquors, sloe gin and rum. On wine Malaysia made a 
number of modifications in its wine definition, but the alcoholic range has not been modified (i.e. 
not less than 7% and not more than 15%). A maximum limit at 15% vol. for wines would contravene 
major  wine producing countries' legislation, often based on the recommendations adopted by the 
International Organisation of Vine and Wine (OIV).  
2.73.  For liqueur wines, the OIV code reads that it is a product with acquired alcoholic strength 
above or equal to 15% a nd below, or equal to 22%. A state can however, for its domestic market, 
apply a maximum acquired alcoholic strength of above 22% whilst remaining below or equal to 24%. 
The EU would like to underline that this unchanged alcoholic range applied in Malaysia  continues to 
be a trade barrier for exporters. Therefore, unless there are objective justifications for such 
deviations, the EU is kindly asking the authorities of Malaysia to align its rules with international 
practices, in line with the standards and de finitions of the OIV. Malaysia has also provided 
clarification concerning the harmonization of references to permitted food conditioners that includes 
reference to polyvinilpyrrolidone in wine (Regulation 362). The EU would like to ask confirmation 
from Ma laysia, that fining agents, including polyvinilpyrrolidone, can continue to be used in imported 
wines in accordance with regulation 19(2), despite of the amendment deleting the reference to wine 
in Table II of the Eleventh Schedule on permitted food condit ioners.  
2.74.  As regards  the reference to the use of plain caramel I (INS 150a), the EU would like to ask a 
confirmation that the reference to "caramel" as a permitted colouring substances in food in Table II 
point 1.(1) in the Seventh Schedule also includes pla in caramel (INS 150a). As regards the definition 
of liqueurs, the requirement that they must not contain less than 17% of alcohol is particularly 
problematic. This is not in line with international practice: under most national legislative frameworks 
for spirits, products with an ABV of 15 -17% can be defined as liqueurs if they meet the other criteria 
in terms of ingredients and production practices. According to the EU legislation on spirit drinks, the 
corresponding minimum threshold is 15% (with an except ion for egg liqueur, whose minimum 
required ABV is 14%). The current position by Malaysia that allowing low ABV (alcohol by volume) 
 
16 For previous statements follow the thread under ID 793 . G/TBT/M/89  
 
- 21 - 
 
  spirit drinks would increase the availability of alcoholic beverages does not seem convincing, since 
other alcoholic beverag es with a lower ABV will continue to be commercialized.  
2.75.  Under the current  conditions, it seems that it will be impossible to import to Malaysia liqueurs 
with an ABV lower than 17%. Therefore, we would like to ask Malaysian authorities to reconsider 
their p osition and to align the rules with international practice. The EU regrets that the absence of a 
general standard for sloe -aromatised spirit drinks category, which leads to the prohibition to sell 
such products, and invites Malaysia to consider amending th e Food Regulation 1985 to include such 
standard. The fact that sloe -aromatized spirit drinks do not currently fit into Regulation 383 for gin 
of the Food Regulation 1985, due to different specification, also points to a more generic issue of 
the absence of  a specific generic "catch -all" spirit drinks standard for those spirit drinks. These drinks 
do not fit into any specific standards however, they comply with generic rules (e.g. minimum ABV, 
based on distilled alcohol of agricultural origin).  
2.76.  The EU would like to invite Malaysia to consider adding such a generic "catch -all" spirit drink 
standard. Concerning sloe gin, given there is no proposed definition in the relevant Regulation, EU 
would like to ask for confirmation that products of an ABV between 25% - 37% can be marketed as 
sloe gin in Malaysia. Finally, Malaysia has provided clarification concerning the possibility to use 
sweeteners listed under food category 14.2.6 of the General Standards for Food Additives (GSFA) in 
rum. However, the EU would like t o point out that GSFA do not include a number of sweetening 
products that are used for sweetening of spirit drinks such as white sugar, concentrated grape must, 
honey or other natural carbohydrate products. Consequently, the EU would still consider a need to 
provide for such possibility in regulation 380 in order to better align it with international practices.  
2.77.  The representative  of Mexico  provided the following statement. The delegation of Mexico 
refers to the amendments and additions to the Food Regulatio ns 1985 of the Government of 
Malaysia, as notified by the Malaysian Government to the Members of this Committee on 
27 October  2022 in document G/TBT/N/M YS/114. Specifically, the delegation of Mexico refers to 
Official Communication No.  500/ROC/089/2022, sent by the Government of Mexico during the public 
consultation period for the measure, indicating the possible impact of thi s measure on tequila and 
mezcal, specifically with regard to their classifications and respective designations.  In this 
connection, the following requests are highlighted: With regard to new Regulation 384A, a request 
was made to differentiate the categori es of tequila and mezcal, on the basis of their distinct 
appellations of origin and specifications, and to include precise definitions based on the 
corresponding Mexican regulations.  Moreover, with regard to Regulation 385, the Government of 
Mexico request ed the removal of the term "tequila" since the Regulation prohibits the inclusion of 
other terms on the front -of-pack label, which is contradictory to the Mexican standard applicable to 
tequila, which requires the declaration of the categories and the diff erent classes of tequila.  In this 
connection, the delegation of Mexico thanks the Government of Malaysia for its reply to these 
comments. However, it asks that the requests of the Government of Mexico be reconsidered with a 
view to avoiding the impact that  the regulation would have on these emblematic Mexican beverages, 
which are subject to specifications contained in the Mexican regulations concerned in order to be 
produced and marketed.  The delegation of Mexico thanks the delegation of Malaysia for giving  its 
consideration to this statement and the requests made therein.  
2.78.  The representative  of Japan  provided the following statement. Japan shares the concerns with 
EU and Mexico about Malaysia's revision of the regulations on alcoholic beverages in food regul ations 
1985. Especially, according to regulation 386, liqueur shall contain not less than 17% volume per 
volume of alcohol. This lower limit of alcohol content differs from the regulations of other countries 
including Japan or EU, and appears more trade re strictive than necessary to fulfil the objective of 
the regulation. Japan requests Malaysia to delete the lower limit of alcohol content of liqueur or relax 
this lower limit from 17% to 15%. Even if Malaysia deletes or relaxes the lower limit of alcohol 
content of liqueur, there would be a shift from a higher alcohol product to a lower alcohol product. 
As a result, it would contribute to the reduction of harmful use of alcohol.  
2.79.  In response, the representative of Malaysia  provided the following statement. Ma laysia thanks 
the European Union, Mexico and Japan for their interest in the Ministry of Health's proposed 
amendments to the regulations 361 to 386A and 387 as well as the insertion of a new 384A 
regulation to the Food Regulations 1985. We also note Japan' s statement and its interest under this 
agenda item. In gist, the current notification involves proposed amendments to the Food Regulations 
1985 on specific requirements of alcoholic beverages in relation to the alcohol content, the addition 
of other ingre dients, the use of food additives and labelling requirements. The purpose of the G/TBT/M/89  
 
- 22 - 
 
  amendments on all provisions of food additives for alcoholic beverages is to harmonize the food 
additive requirements with the Codex General Standard for Food Additives (GSFA,  Codex STAN 192 -
1995), in line with subregulation 19(2) of the Food Regulations 1985. On this note, the conditions 
under which food additives may be used in alcoholic beverages can be directly referred to GSFA, 
Codex STAN 192 -1995.  
2.80.  The deadline  for comment s on this notification was 26 December 2022 and Malaysia thanks 
the European Union and Mexico for providing their comments and proposals within the stipulated 
timeline. In general, the regulations of all food commodities under the Food Regulations 1985 are  
revised systematically based on the implementation of the five -year review framework. This review 
is carried out based on the schedule and timeframe that have been established according to certain 
commodity groups. For alcoholic beverages, announcements f or requests on any proposed 
amendments were made in 2020 through the relevant website. During that period, interested parties 
may submit any proposed amendments or new proposed regulations related to alcoholic beverages 
to the Ministry of Health for consid eration. These exercises were completed in 2021 and then 
proceeded with the relevant process including public consultations. As the proposed amendments 
are now in the process of being gazetted, any new proposals received after the cut -of date in 2021 
are being reviewed separately. Until the proposed amendments are gazetted and entered into force, 
the existing regulations under the Food Regulations 1985 are still in force and applicable.  
2.81.  Malaysia has submitted our responses to the EU on 3 February 2023. We t ake also note of 
the statement by the EU which was submitted earlier via the eAgenda as well as the ones delivered 
today. Our capital is currently reviewing the comments and will provide our response in due course. 
Malaysia has also provided our responses to Mexico's comments and suggestions on 3 February 
2023. Based on Mexico's statement today, Malaysia would require further clarification on some of 
the comments before we could provide our response and we propose for this matter to be discussed 
in detail b ilaterally. With regard to Japan's statement, we would appreciate the written statement is 
provided, to be submitted to our capital for further review and we will provide a response in due 
course. Moving forward, Malaysia welcomes further bilateral dialogu es and engagements with the 
European Union, Mexico and Japan to address the concerns raised. We kindly seek your 
understanding and cooperation on this matter.  
2.1.3   Previously raised c oncerns  
2.1.3.1   China - Requirements for information security products, including, int er alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29417) 
2.82.  The representative of the European Union  provide d the following statement. The EU would 
like to refer to its comments, raised at previous TBT Committee meetings as regards the Multi -Level 
Protection Scheme (MLPS), specifically concerns around the unwarranted and significant market 
entry restrictions, in cluding by demanding that all networks above Level 3 be subject to certain legal 
obligations that were originally destined for Critical Information Infrastructure (CII). The EU calls for 
enhanced proportionality and transparency in the implementation of th e Cyber -MLPS.  
2.83.  The representative of Japan  provided the following statement. Japan remains concerned about 
China's Regulation on Commercial Encryption Products and Cybersecurity Multi -Level Protection 
Scheme. We request that China provide information on the  status of its consideration of the draft 
Regulation on Commercial Encryption Products, which was open for comment until 19 September 
2020, and the Cybersecurity Multi -Level Protection Scheme, which China said was being drafted at 
the Committee meeting in July 2022, and that a transparent system be put in place.  
2.84.  In response, the representative of China  provided the following statement. China would like 
to thank the EU and Japan for their continued interest in the Regulation on commercial encryption 
products  and the Multi -Level Protection Scheme. With regard to the management of commercial 
encryption products, China has, from 1 January 2020, cancelled the approval of varieties and models 
of commercial encryption products, and established a unified certificati on scheme for commercial 
cryptography. The management of commercial encryption products fully reflects the principles of 
non-discrimination and fair competition. It treats domestic and foreign products and companies 
 
17 For previous statements follow the thread under ID 294 . G/TBT/M/89  
 
- 23 - 
 
  equally. China implements mandatory test ing and certification on commercial encryption products 
that involve national security, national economy, people's livelihood, and public interest, and 
implements voluntary testing and certification on other commercial encryption products.  
2.85.  To protect netwo rk and data security, in 2007, China has enacted Measures for the 
Administration of Classified Protection of Information Security, and begun to implement Classified 
Protection of Information Security (now called Classified Protection of Cybersecurity) syst em. In 
2016, Cybersecurity Law of China stipulates that the state shall implement the system for classified 
protection of cybersecurity, thus establishing the legal status of the system. The system for classified 
protection of cybersecurity has become a ba sic national policy and system in the field of 
cybersecurity in China, and has played an essential role in the maintenance and protection of 
cybersecurity. As required by the system, information systems are divided into five levels based on 
respective impo rtance and the harm when damaged. Operators for level II and above shall file 
records to the public security authority. Operators shall determine the level based on relevant 
national normative documents, technical standards, and their own actual operations , and implement 
different protection strategies respectively, to effectively strengthen protection for the network and 
data. The practice is consistent with common international practices.  
2.1.3.2   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 39318) 
2.86.  The representative of Costa Rica  provided  the following statement. Costa Rica once again 
reiterates its support for this trade concern raised by Australia and supported by Brazil, Kenya and 
Canada, as we have done on previous occasions.  Costa Rica is concerned about the hazard -based 
approach adop ted by the EU given that the obligations of the multilateral system require all technical 
requirements to be aligned with an international reference standard or a risk assessment providing 
the scientific basis for the measure. Costa Rica once again urges t he EU to ensure that the 
implementation of its regulations is based on risk assessments that meet criteria supported by 
sufficient scientific evidence, in line with the obligations set out in the TBT Agreement.  
2.87.  The representative of Australia  provided the following statement. Australia remains concerned 
about the significant uncertainty surrounding the mechanisms for setting import tolerances for 
substances falling under the hazard cut -off criteria. We consider that reduction of allowable residues 
in import ed products to the limit of determination would impose a de facto ban on the usage of those 
products in trading partners should they wish to export to the EU. Regarding import tolerance 
applications for clothianidin and thiamethoxam, we seek clarification on how EU regulators are better 
placed to assess effects on pollinators in third countries? This is considering the Australian pesticides 
regulator – the Australian Pesticides and Veterinary Medicines Authority (APVMA) – must consider 
impact on off -target species in its assessments of products for registration. Australia maintains that 
the use of food residue limits to pursue domestically set environmental policy outcomes in third 
countries is inappropriate as it does not account for variations in risk stem ming from differences in 
pollinator species, environmental conditions and chemical use practises around the world.  
2.88.  Australia reiterates its position from previous meetings about the importance of adopting a 
risk-based approach for regulating plant protecti on products rather than considering only the 
potential for harm due to the intrinsic properties of a chemical. We remain available to discuss our 
approach to pesticide regulation with the EU and look forward to continued and constructive 
engagement on this  issue, including in the SPS Committee.  
2.89.  The representative of Kenya  provided the following statement. Kenya would like to refer to 
her previous statement on this specific trade concern. Kenya continues to support the other 
delegations that have raised this  issue, since the measure is deemed to be more trade restrictive 
than necessary contrary to Article 2.2 of the TBT Agreement. Kenya reiterates that a risk -based 
approach is the best global practice that meets the intended objective. Adoption of the hazard -based 
system by the EU has the potential to create unnecessary barriers to trade. The proposed measure 
would be deemed to be in contravention of Article 12.3 of the TBT Agreement which requires that 
"Members shall, in the preparation and application of tec hnical regulations, standards and conformity 
assessment procedures, take account of the special development, financial and trade needs of 
 
18 For previous statements follow the thread  under ID 393 . G/TBT/M/89  
 
- 24 - 
 
  developing country members, with a view to ensuring that such technical regulations, standards and 
conformity assessme nt procedures do not create unnecessary obstacles to exports from developing 
country members ". Kenya requests EU to withdraw this measure.  
2.90.  The representative of Canada  provided the following statement. Canada would like to take 
this opportunity to once again echo the concerns raised by other Members regarding the European 
Union's (EU) hazard -based regulation for active substances in plant protection products and the 
setting of import tolerances. We encourage the EU to take an approach that does not unnecessarily 
limit the availability of all crop protection tools for growers. Regulatory decisions based on 
assessments of both hazards and risks for all active substances ar e 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. 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. We have 
in place an effective regulatory regime to monitor the safe use of pesticides including clear labelling 
requirements. Farmers need to have access to a wide range of effective and affordable plan t 
protection products, including both chemical and biological options, to ensure plant health and 
minimal waste. Using integrated pest management approaches, we support farmers in their own 
assessment of what is needed according to growing conditions, mark et demand, and other factors.  
2.91.  Canada's rigorous regulatory requirements, including scientific assessments and monitoring 
programs, ensure the health and safety of consumers where pesticide residues can be a factor, as 
well as the health of the environment.  Canadian growers and exporters have yet to be convinced of 
the real -world feasibility, commercial viability, and compliance with international obligations of the 
EU's proposed approach for setting import tolerances when a plant protection product has met the 
hazard -based cut -off criteria. In past Committee meetings, the EU has mentioned that comments 
from third countries are duly taken into account in the EU's decision -making processes. Can the EU 
please explain how this feedback is coordinated, reviewed, and considered? 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 assessmen t as part of the re -authorization process would likely be needed, regardless 
of the results of the hazard screen.  
2.92.  The representative of Brazil  provided the following statement. Brazil would like to refer to its 
previous statements regarding STC 393.19 We emphasize that regulations on endocrine disruptors 
should be established according to sound scientific principles, taking all available data into 
consideration. Serious evaluations must be able to separate chemicals that have the potential to 
cause harm due  to their endocrine mode of action from those substances that do not pose a threat 
to human health. A solid risk analysis, consistent with Codex guidelines, is important to ensure 
transparency and predictability in the regulatory processes regarding plant protection products and 
LMRs. The EU affirms that granting import tolerance would make its regulation adherent to the risk 
analysis principle. This very principle is indeed one of the issues that has been raised in this STC 
over recent years. EU concedes e mergency authorization to its national member States and deny 
import tolerances to third countries where the same conditions prevail. Brazil believes that the 
European approach to limit the use of pesticides is more trade -restrictive than necessary to fulf ill 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.  
2.93.  The representative of El Salvador  provided the following statement. El Salvador reiterate s the 
position expressed at previous meetings of this Committee, and we echo the comments made by 
other Members in relation to the concern about the imposition of measures by the European Union 
on the basis of a hazard -based approach, rather than a risk -based approach established using 
scientific criteria in accordance with international standards so that these measures do not constitute 
a trade restriction. El Salvador will continue to follow up on this issue.  
2.94.  The representative of Ecuador  provided the following statement. Ecuador once again thanks 
the delegations of Costa Rica and Australia for maintaining this concern on the agenda of our work 
within this Committee.  My delegation reiterates its support for this trade concern and shares th e 
points and doubts set out in the statements of previous speakers. My country recognizes and shares 
the genuine interest in the importance of protecting human and environmental health. However, we 
 
19 European Union - Hazard -based approach to plant protection products and setting of import 
tolerances  (ID 393 ). G/TBT/M/89  
 
- 25 - 
 
  consider that regulatory decisions adopted on the basis of  hazard -based criteria are not consistent 
with international risk -assessment practice, given that there is no consideration of exposure.  
Ecuador urges the European Union to take into consideration the relevant scientific information 
emanating from internat ional specialized agencies recognized by the WTO, such as the Codex 
Alimentarius, which has relevant information on pesticides. This is in order not to be more trade -
restrictive than necessary to fulfil a legitimate objective, in accordance with Article 2. 2 of the TBT 
Agreement.  The precautionary approach has resulted in approvals of active ingredients being 
withdrawn for lack of data and MRLs being reduced to the limit of detection. Consequently, my 
country once again calls on the EU to ensure that, in cas es where scientific information is lacking, 
the EFSA does not make a recommendation on the MRL, since decisions on regulatory measures 
must be based on conclusive risk analyses that offer real conditions for health protection so as to 
avoid becoming a tech nical barrier to trade.  
2.95.  The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and refers to its previous statements, while stressing the importance of adopting a scientific 
approach  to the regulation of phytosani tary products based on the risk and not just on the hazard 
arising from the intrinsic properties of a chemical.  In this regard, Paraguay once again requests the 
European Union to take into consideration information on pesticides provided by the specialized  
agencies recognized by the WTO, such as the Codex Alimentarius; to reconsider its approach; to 
base its decisions on conclusive scientific evidence and real risk weightings, in accordance with 
international standards and principles; to ensure import toler ances; and, where necessary, to 
provide sufficient transition periods.  
2.96.  The representative of Uruguay  provided the following statement. We support the comments 
made by the preceding Members and reiterate our systemic  trade concern relating to the European 
Union's use of a hazard -based approach, instead of an approach based on comprehensive scientific 
risk assessments, when adopting regulatory decisions concerning the authorization of active 
substances used in plant protection products, and when setting impor t tolerance levels for 
substances that fall within  the cut -off criteria in Regulation No 1107/2009.  We wish to once again 
emphasize the need to base such determinations on conclusive scientific evidence, gathered from 
an assessment of actual risks, to avoi d the withdrawal, despite their safe use, of certain active 
substances that continue to be important components of the pest -management system. This is 
because an approach based on hazard rather than actual risk may have negative and 
disproportionate impact s on production, while contributing little or nothing to the stated aim of 
protecting public health.  As always, Uruguay continues to support any multilateral work undertaken 
by the Codex Alimentarius to develop a harmonized, risk -based approach to the trea tment of plant 
protection products and MRLs for foods that would ensure the protection of health while also 
facilitating international trade. In the meantime, we once again call on the EU to listen to and address 
the concerns expressed by many Members, and  to reconsider its regulatory approach with a view to 
preventing the unjustified proliferation of barriers to international trade in agricultural products and 
their potential socio -economic consequences for other Members.  
2.97.  The representative of Chile provided the following statement. The delegation of Chile wishes 
to refer to the specific trade concern raised recently, with respect to the fact that the tolerances 
imposed by the EU on various plant protection substances must be risk -based, given their effect s on 
Chile's foreign trade in agricultural products.  
2.98.  The representative of Guatemala  provided the following statement. Guatemala thanks Costa 
Rica and Australia for including this item on the agenda. We reiterate our previous statements. We 
are concerned a bout the hazard -based approach rather than the recognition of international 
standards, what are key to harmonizing regulations of this type internationally, in particular because 
they base their results on a risk analysis which provides a scientific basis for the measures. We 
request the European Union to consider measures that do not create unnecessary barriers to 
international trade and to preserve the WTO's commitments and principles.  
2.99.  In response, the representative of the European Union  provided the fol lowing 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 G/TBT/M/89  
 
- 26 - 
 
  since 10 November 2018 onwards and included in Commission Regulation (EU) No 2018/605.20 This 
is complemented by a guideline by the European Food Safety Authority (EFSA) and the European 
Chemicals Agency (ECHA), providing more details on how to interpret these criteria, and available 
to WTO Members.21 We are aware of general concerns on EU po licy on plant protection products for 
the definition of scientific criteria to identify endocrine disruptors and on the establishment of import 
tolerances for substances not authorized in the EU, due to the so -called "cut-off" criteria in 
Regulation (EC) N o 1107/200922 on plant protection products. As previously explained, the European 
Union decided to follow the procedures of Regulation (EC) No 396/2005 for the management of 
import tolerance requests concerning active substances falling under these cut -off criteria, which 
include a risk assessment by an Evaluating EU member State and a scientific opinion by the European 
Food Safety Authority (EFSA). The granting of the import tolerance is then considered in line with 
risk analysis principles on a case -by-case basis and taking into account all relevant factors. During 
the thematic session on Trade Facilitating Approaches to Pesticide MRLs, in the margins of the SPS 
Committee of 22 March 2022, the EU provided an overview of the methodology used in EU for 
pesticide residues risk assessment.23 The EU reiterates its commitment to act in full transparency 
and keep Members duly informed about further developments.  
2.1.3.3   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629 , G/TBT/N/EU/826  (ID 53924) 
2.100.   The representative of the Russian Federation  provided the following statement. We would 
like to briefly remind that in October 2019, the EU published a Regulation on classification, labelling 
and packaging of substances and mixtures that unr easonably and unjustifiably considers cobalt 
carcinogen. For several years in various WTO bodies, the Russian delegation has been calling on the 
European delegation to provide scientific justification for such action or to apply the specific 
technological method of gastric bioelution for repeated investigation and assessment of the 
carcinogenicity of cobalt. In fact, the gastric bioelution method is still not approved by the EU, despite 
the fact that two years ago the Cobalt Institute completed all formal p rocedures under the legislation 
of the European Union to initiate scientific study on carcinogenicity of cobalt metal for oral route of 
exposure. According to the Cobalt Institute data, the data and figures in the EU Regulation on the 
carcinogenicity of co balt are based on an approach that does not use the best available scientific 
data.25 In December 2022, the European Union revised the CLP regulation and published a new 
proposal, but unfortunately, our comments, as well as the results of scientific studie s of the Cobalt 
Institute were not taken into consideration, neither incorporation of the gastric bioelution. We would 
like to reiterate our concern regarding the classification of cobalt and urge the EU to incorporate 
bioelution into the CLP regulation. Finally, it is regrettable that the EU has chosen not to engage on 
this issue as it has been refusing to respond to present concerns for several meetings in a row. This 
situation is of systemic concern. Transparency is an important pillar of the WTO  and pro vision of 
explanation o n various measures and policies in this Committee is part of the transparency 
mechanism. Refusal to respond to the raised trade concerns is in stark contrast to the EU 's rhetoric 
about the importance of transparency in this organizat ion. 
2.1.3.4   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53326) 
2.101.   The representative of the European Union  provided the following statement. The EU has 
raised the Security  Review of Network Products and Services, among many aspects of the 
Cybersecurity Review Measures, in this Committee on several occasions, stressing our concerns 
related to these measures, which entered into force on 1 June 2020, were subsequently amended 
in January 2022, and entered into force on 15 February 2022. We remain concerned that the 
 
20 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. OJ L 101, 
20.4.2018, p. 33.  
21 https://doi.org/10.2903/j.efsa.2018.5311  . 
22 Regulation (EC) No 1107/2009 of the Euro pean Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives  
79/117/EEC and 91/414/EEC. OJ L 309 24.11.2009, p. 1.  
23 https://www.wto.org/english/tratop_e/sps_e/thematicsession220322_e.htm . 
24 For previous statements follow the thread under ID 539 . 
25 Occupational Exposure Limits: EU internal work on cobalt risks squandering EU green transition goals 
| Cobalt Institute  
26 For previous statements follow the thread under ID 533 . G/TBT/M/89  
 
- 27 - 
 
  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 operator s. The Amended Measures contain 
few explanations of the issues we raised before and new issues have arisen since then.  
2.102.   The Measures expand the scope of the application from Critical Information Infrastructure 
Operator's (CIIO) purchase of network products and services, to online platform operators carrying 
out data processing activities. A newly imposed requirement is that online platform operators holding 
personal information of more than one million users, and that are newly listed on foreign markets, 
must report for review. The Measures include very broadly defined triggers, such as security, 
openness, transparency and diversity of supply sources, as well as "political, diplomatic and trade 
factors ". The review is perceived as being lengthy and untranspar ent, and may subject suppliers to 
exposure of trade secrets. The EU considers that, in this environment, domestic companies may be 
favoured over international ones. It remains unclear who would be a "data processor " or when they 
would be engaged in "data p rocessing activities ". Understanding this scope is necessary as it 
determines if and when an application would have to be filed.  
2.103.   The EU urges China to clarify if "a data processor carrying out data processing activities " 
applies only to a data processor re gistered in China and processing data in China, and excludes 
overseas data processors that process data outside of China. The EU seeks clarification on the 
following points: Based on the previous draft, entities subject to Cybersecurity Reviews have 
change d from "data processors " to "online platform operators ". The final Measures do not define 
"online platform operators ", but the Draft Network Data Security Regulations define the term 
"Internet platform operators " as "data processors who provide Internet platform services such as 
information publishing, social networking, transaction, payment or audio -visual services ". The EU 
urges China to clarify if the scope of "online platform operators " is narrower than "data processors ", 
which was used previ ously and 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. The EU urges China to clar ify the 
following terms: "core data ", "important data ", "important communication product " and the scope 
of "network products and services ". Overall, the EU urges China to ensure clarity, transparency and 
objectiveness in the security review so that the Mea sure does not create market access barriers.  
2.104.   In response, the representative of China  provided the following statement. China would like 
to thank the EU for its continued interest in the – Draft implementing measures for the Cybersecurity 
Review of Network  Products and Services. The Chinese Government administers the internet in 
accordance with laws and regulations. In April 2020, the Cyberspace Administration of China and 12 
other departments jointly formulated the Cybersecurity Review Measures, which took  effect on 
1 June 2020. The Measures for Cybersecurity Review of products and services, which came into force 
on 1 June 2017, were repealed at the same time. In 2021, the Cyberspace Administration of China 
and 13 other departments jointly revised the Cyber security Review Measures, which took effect on 
15 February 2022. The cybersecurity review of the procurement of network products and services 
by the operators of critical information infrastructure has been carried out in accordance with the 
National Secur ity Law and the Cybersecurity Law of China. Conducting a cybersecurity review is 
necessary to safeguard cybersecurity and national security. It is also a common practice of all 
Members, and many Members have taken legal and administrative measures in this regard. China 
will, as always, welcome foreign products and services to enter the Chinese market in compliance 
with the requirements of Chinese laws and regulations.  
2.1.3.5   Colombia - Food Prioritized for its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1 , G/TBT/N/COL/246  (ID 60927) 
2.105.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its appreciation for the efforts of the Colombian authorities to prov ide information related 
to its regulation on the maximum sodium content for a prioritized list of foods. In this regard, we 
note that our capitals have had exchanges on the reasons and justification for this Colombian 
regulation.  However, Costa Rica would like to reiterate its request that Colombia share with us either 
the Codex standard setting out the percentages for the maximum sodium content per food, or the 
risk analysis performed in order to determine these percentages.  As in the case with front -of-pack 
nutritional labelling, there are no international reference standards that form the basis for setting 
percentages for the maximum sodium, fat or sugar content, above which a specific product cannot 
 
27 For previous statements follow the thread under ID 609 . G/TBT/M/89  
 
- 28 - 
 
  be sold in a particular market (as is the case wi th the list of foods prioritized by Colombia and the 
maximum sodium percentages) or a stop sign or a black stamp must be placed on the package to 
discourage consumption of the product. As a result, there are different regulatory schemes for the 
internation al trade in processed foods, which make sectors less competitive and are more trade -
restrictive than necessary.  We remain open to bilateral dialogue in Geneva and once again thank 
the support we have received from the Colombian authorities until now.  
2.106.   The r epresentative of Paraguay  provided the following statement. We thank Costa Rica for 
the inclusion of this trade concern on the agenda and we request that Paraguay's support be 
recorded.  Paraguay recognizes and supports the right of Colombia to protect the health of its 
population by limiting the sodium content of some foods as part of efforts to protect against chronic 
non-communicable diseases. However, Paraguay is concerned that the procedure is more restrictive 
than necessary to achieve the legitimate ob jective pursued by Colombia with this measure.  In 
particular, it is concerned that the first party declaration may no longer be used, given the 
accreditation of an entity to certify compliance and the expiry of the period for using this type of 
certificati on (two years from the accreditation of the certifying entity).  
2.107.   We believe that there are still not enough accredited laboratories to date to deal with all 
certification requests that will have to be managed as of July when the deadline for the use of firs t 
party certifications expires, which could generate a bottleneck in applications.  While the possibility 
exists of having recourse to an certification body accredited abroad and recognized by Colombia, 
this would involve much greater cost, and some small a nd medium -sized Paraguayan enterprises 
would not be able to avail themselves of this option.  For these reasons, Paraguay requests Colombia 
to increase the availability of certification bodies accredited in Colombia and to complement them in 
an appropriate manner with certification bodies accredited in other countries so as to increase the 
number of available certification entities, thereby reducing bottlenecks and helping to reduce 
certification costs.  
2.108.   The representative of Guatemala  provided the following statement. Guatemala appreciates 
the inclusion of this item on the agenda. Guatemala reiterates its comments made in the previous 
Committee. As the issue of companies' certification and the process and lack of certification abroad 
is a source of concern fo r us, we would be grateful if Colombia could shed further light on the 
procedure and implementation to ensure that this does not become an unnecessary barrier to trade.  
2.109.   In response, the representative of Colombia  provided the following statement. First, we  
would like to express our gratitude for the comments made by some Members on previous occasions 
and at this meeting.  Second, we note that Resolution No. 2013 of 2020 reflects public health policy, 
whose objective is to reduce mortality attributable to hig h blood pressure and cardiovascular disease 
by gradually reducing salt intake from food sources, until the WHO recommendation has been 
achieved.  In the past, Colombia has shared and discussed the documents underlying the measure 
taken through the aforement ioned Resolution on maximum sodium content in processed foods.  In 
fact, in the previous Committee, we mentioned the importance of the work done with Costa Rica and 
the need for clarification of its concern since although this refers to the technical regula tion on 
maximum sodium content, the arguments and treatment of the subject matter refer to a regulation 
on nutritional and front -of-pack labelling.  On the other hand, and with respect to the comments 
made by Paraguay in the previous Committee, I would poin t out that the importer or domestic 
manufacturer may opt for any of the accredited certification schemes permitted, in order to obtain 
the relevant certificate of conformity, that is, it would not be limited to the batch certification scheme.  
2.110.   On the other hand, and in response to Guatemala's concerns , also raise in the last Committee 
meeting,  regarding the acceptance of the first -party declaration, it is expected that such a 
declaration will be valid for a period of 24 months from the date on which the firs t certifier has 
obtained accreditation in accordance with the provisions of the Colombian Technical Standard or by 
laboratories accredited by a foreign accreditation body  that form part of the Mutual Recognition 
Agreement for International Laboratory Accre ditation Cooperation . Third, and to conclude, I would 
like to reiterate the willingness of our authorities to continue technical discussions with the 
authorities of the countries concerned, with a view to clarifying the concerns raised and providing 
elemen ts that facilitate understanding and compliance with the rules.  G/TBT/M/89  
 
- 29 - 
 
  2.1.3.6   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9  (ID 60828) 
2.111.   The representative of Costa Rica  provided the following statement. Costa Rica would like to 
reiterate this concern and emphasize the importance of harmonizing food labelling schemes, in 
particular front -of-pack nutritional labelling, on the basis of Codex regulations (Guidelines on 
Nutrition Labelling CXG 2 -1985, Annex 2, adopted in 2021).  In this regard, we invite Mexico to use 
the recently approved Codex guidance on the subject as a reference to ensure that regulations are 
consistent with the international consensus and do not create unneces sary restrictions on trade.  
Costa Rica upholds the importance of the work done in the framework of the Codex Alimentarius, as 
well as the need for any food labelling measures adopted to be based on scientific evidence and on 
Codex standards, as set out in the Agreement on Technical Barriers to Trade.  To date, the Codex 
Alimentarius has not defined percentages of sodium, sugar or fat content above which consumers 
must be warned through labels with stop signs or black stamps which are designed to discourag e 
consumption of the product. This lack of harmonization and scientific evidence has led to the 
proliferation of various front -of-pack food labelling schemes with different content -percentage 
thresholds at which a warning is required, all of which increase s the costs associated with 
international trade in food, makes businesses less competitive and ultimately creates unnecessary 
barriers to trade.  
2.112.   The representative of Paraguay  provided the following statement. We thank Costa Rica for 
including this trade c oncern on the agenda and request that the statement made by Paraguay at the 
previous meeting be reflected in full in the minutes of this meeting.  
2.113.   Statement from November  2022 meeting, in full.29 Paraguay supports Mexico's goal of 
protecting public health a nd considers that the provision of nutritional information to consumers is 
an appropriate strategy. However, Paraguay expresses its concern over its enforcement since there 
is no analytical method for distinguishing total sugars from added sugars in food. Therefore, we 
would ask Mexico if this would not render enforcement difficult.  
2.114.   In response, the representative of Mexico  provided the following statement. We appreciate 
the comments made and the consideration given by the delegations of Costa Rica and Para guay 
regarding Mexican Official Standard (NOM) 051 on the labelling of food and non -alcoholic beverages.  
The Government of Mexico recognizes the importance of the use of international standards and 
guidelines as a basis for the development of technical reg ulations and takes note of the comments 
expressed by Costa Rica. However, it notes that, at the time NOM  051 was drawn up, there were no 
international reference standards or guidelines that could be used as a basis for the establishment 
of front -of-pack la belling.  We also note that the adoption, modification and/or cancellation of 
technical regulations in Mexico is subject to the standardization process set out in the Quality 
Infrastructure Law and the processes established in this Law, which provide for co mpliance with 
international commitments relating to the issuance of these instruments.  At the moment, the 
above -mentioned Mexican legislation is not included in the 2023 National Quality Infrastructure 
Programme, and therefore it is not scheduled to be ame nded in the near future.  However, the 
Mexican Government reiterates its commitment to the fulfilment of the international obligations 
contained in the TBT Agreement and in the free trade agreements to which it is party, while 
recognizing the legitimate pub lic interest objective of safeguarding the health of the population.  
2.1.3.7   India - Indian standards and import restrictions in the automotive sector (Quality 
Control Orders): wheel rims, safety glass, helmets, G/TBT/N/IND/118 , 
G/TBT/N/IND/147 , G/TBT/N/IND/167  (ID 64930) 
2.115.   The representative of the European Union  provided the following statement. The EU 
appreciates the deferment of implementation of QCOs on safety glass and wheel rims. However, the 
EU would like to recall 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, introduced by relevant QCOs. The EU once more reiterates to India 
to kee p the BIS marking as optional for components, which are already in compliance with the UN 
 
28 For previous statements follow the thread under ID 608 . 
29 G/TBT/M/88 , para. 2.364.  
30 For previous statements follow the thread under ID 649 . G/TBT/M/89  
 
- 30 - 
 
  marking requirements. The EU would like to know whether India would be ready to accept 
provisionally UN type approvals and markings. The EU would like to stress that required conformity 
assessment procedures are not in line with Article 5.1.2 of WTO TBT Agreement which provides that 
"conformity assessment procedures shall not be more strict […] 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. " Considering this, 
the EU would like to request India to reconsider the introduction of the QCOs on automotive  safety 
glass and wheel rims. The EU also recalls its earlier suggestion to keep the BIS marking as optional 
for components that are already in compliance with the current marking requirements. The EU 
reiterates its request to the Indian authorities to con sider preparing rules for international 
recognition of laboratories by the BIS, as foreseen by legislation in place. This would speed -up audits 
and lower the cost of mandatory testing for foreign manufacturers.  
2.116.   In response, the representative of India provided the following statement. The Safety Glass 
(Quality Control) Order 2020 has been subjected to three extensions basis requests received, 
indicating that sufficient time has been granted to foreign and domestic manufacturers. Secondly, 
the concerns raise d by EU have already been replied in the previous Committee meeting.  
2.1.3.8   China - Commercial Cryptography Administrative Regulations (ID 64431) 
2.117.   The representative of the European Union  provided the following statement. The EU remains 
concerned about this implem entation measure of the Cryptography Law, and sent comments to the 
State Cryptography Administration (SCA) in September 2020. Specifically, concerns relate to (i) the 
scope of the law; (ii) the protection of intellectual property; (iii) the imposition of p re-market and 
export controls; (iv) the vague requirements around testing and certification, and the turning of 
voluntary certification requirements into de facto market access prerequisites; (v) the imposition of 
additional "national security reviews"; an d (vi) the use of domestic standards, along with the lack of 
meaningful access to pertinent Chinese standards development organizations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in order to ensure t hat 
legal and regulatory requirements are applied in a non -discriminatory manner, do not favour specific 
technologies, do not limit market access and do not lead to forced transfers of intellectual property.  
2.118.   Additionally, the EU encourages the SCA to open up, in practice, the Working Group 3 on 
Cryptographic Technology of the National Information Security Standardisation Technical Committee 
(TC260) and the "Cryptography Industry Standardisation Technical Committee" (CISTC) to foreign -
invested industry based  in China. Finally, in view of the existing controversies surrounding the 2020 
version of this draft Regulation, and since the draft is currently with the Ministry of Justice, the EU 
calls on the Ministry to hold another round of public consultations befor e the regulation is finalized. 
The EU would appreciate its comments being taken into consideration and invites China to notify the 
draft regulations to the WTO.  
2.119.   In response, the representative of China  provided the following statement. China welcomes 
the EU's continued interest in China's commercial cryptography regulations. The Revised Regulations 
on the Administration of Commercial Cryptography have been included in the State Council 
Legislation Plan for 2022. The revision of the regulations follows law -based, democratic, and 
scientific principles. It will be open and transparent.  
2.1.3.9   European Union - Draft EU Batteries Regulation (implementation of the European 
Green Deal), G/TBT/N/EU/775  (ID 68532) 
2.120.   The representative of the Russian Federation  provided t he following statement. The Russian 
Federation would like to refer to its statements at previous TBT Committees with regard to the 
Regulation of the European Parliament and of the Council concerning batteries and waste batteries. 
The Russian Federation has  been raising this issue in the TBT Committee since June 2021. However, 
up to now the EU has failed to provide clarification on specific scientific justification of proposed 
measure, as well as the relevant international standards. This concern relates to,  inter alia , the 
maximum level of carbon footprint over the lifecycle of batteries, minimum level of certain recycled 
materials, as well as additional restrictions on the use of cobalt, lithium and nickel. We reiterate a 
request that the EU clarify if less  trade restrictive measures to stimulate recycling of nickel, lithium, 
 
31 For previous statements follow the thread under ID 644 . 
32 For previous statements follow the thread under ID 685 . G/TBT/M/89  
 
- 31 - 
 
  cobalt, copper and lead were considered rather than such administrative measure as minimum level 
of recycled materials in the battery.  If yes, we request the reasons as to why these mea sures haven't 
been employed or proposed for implementation. Finally, Chair, it is regrettable that the EU has 
chosen not to engage on this issue as it has been refusing to respond to present  concerns for several 
meetings in a row. This situation is of syst emic concern. Transparency is an important pillar of the 
WTO and provision of explanation s of various measures and policies in this Committee is part of the 
transparency mechanism.  
2.121.   The representative of China  provided the following statement. China suppor ts the EU's 
efforts for better regulation of batteries and waste batteries and would like to thank the EU for 
responses to our previous  comments . However we still have some concerns which have not been 
resolved, as follows. China would like to know the pro gress in formulating calculation methods for 
carbon footprint and recycled content by the EU side. And we would like the EU to engage other 
Members in the policy -making process. China would also like the EU to timely update the carbon 
footprint database an d adopt data from non -EU institutions as necessary and appropriate. Also, the 
EU is reminded to note that the requirement on relevant technical documents may result in the 
disclosure of commercial secrets. The required information such as the content of co balt, nickel, 
lithium contained in batteries, and carbon emission date in the production process of electrolyte and 
isolation membrane, involves multiple core business secrets. To disclose such information in the 
technical documents poses a risk of secret leakage. It is recommended to set relevant protection 
clauses or cancel the disclosure of the technical documents containing commercial secrets when the 
regulatory objectives could be satisfied otherwise.  
2.122.   Regarding point 3 of Article 9, it is recommended t o phase out the non -rechargeable portable 
batteries in accordance with their types, for example, to phase out the non -rechargeable, non -
lithium portable batteries of general application. We believe that without safety issues and serious 
pollution, the elim ination of a certain type of portable battery should be achieved by the market, 
technology development and users, not by legislation. Regarding the requirement for manufacturers' 
registration in articles 46 and 47, it is recommended to allow producers to r egister in only one EU 
member State, for example in the country of the importer, which is the main importation country, 
rather than in all EU member States. We suggest the EU consider establishing a single EU regulatory 
system where producers could identif y one EU member State as the main target market and perform 
their procedural responsibility only once.  
2.123.   In response, the representative of the European Union  provided the following statement. 
The EU would like to thank China for their comments on the propos al for an EU Batteries Regulation. 
I will try to address the Chinese concerns in the order that they were raised: First, in relation to the 
progress in formulating calculation methods for carbon footprint and recycled content, the EU would 
like to inform C hina that the preparatory work for this is in its early stages. The Joint Research 
Centre of the European Commission is preparing the technical work for the delegated acts. On carbon 
footprint, the Joint Research Centre already held several meetings with s takeholders on the 
methodology for electric vehicle batteries. However, the EU would like to reassure China that the 
implementing and delegated acts that will be developed under the notified draft will include 
consultations with stakeholders. Furthermore, drafts of those implementing measures and delegated 
acts will also be notified to the WTO in accordance with the TBT Agreement.  
2.124.   Two, there is no specific carbon footprint database related to the battery regulation. But, the 
EU aims to make available a carb on footprint calculation tool for batteries that can be used freely by 
economic operators for the purpose of the battery regulation. Three, the EU intends to amend the 
text of the proposal so that it makes clear that the technical documentation that the ma nufacturer 
draws up to demonstrate compliance with the requirements of the regulation will remain a 
confidential document, only to be shared with notified bodies, and with public authorities at their 
request. For certain other sensitive information, the Re gulation and its implementing acts will include 
provisions to ensure that the information is only shared with those that need it. Four, as for the 
review to assess the feasibility of measures to phase out the use of non -rechargeable portable 
batteries of g eneral use, the EU considers it more appropriate to achieve its intended objectives to 
carry out an assessment encompassing all such batteries together. But, of course, the EU will 
consider the specificities of the different battery types and chemistries. Finally, an EU -wide register 
of battery manufacturers is a long -term goal of the EU's waste policy. However, for the time being, 
the EU has chosen to maintain the approach of the existing EU Batteries Directive, since in recent 
years considerable investmen ts have been made in the implementation of the current registers of 
battery producers.  G/TBT/M/89  
 
- 32 - 
 
  2.1.3.10   European Union - Proposal for a regulation of the European Parliament and the 
Council laying down harmonised rules on artificial intelligence (Artificial intelligence ac t) 
and amending certain union legislative acts (ID 73633) 
2.125.   The representative of China  provided the following statement. China supports the EU's 
governance on artificial intelligence, however, from the perspective of not creating unnecessary 
trade barriers,  China would like to raise concerns as follows . For Article 43.3, we would like to stress 
that it is not appropriate to determine whether an AI system needs a third -party Notified Body to 
participate in the conformity assessment according to the requiremen t in Annex II A. For example, 
for radio equipment defined as AI systems, even if the provider has used all the harmonized 
standards related to AI regulations when the radio frequency standards relating to their products 
are not harmonized, a third -party No tified Body is still required in accordance with the RED Directive. 
It is recommended that the conformity assessment for AI systems in Appendix II A could be in line 
with article 43.1. For article 71, we would like to stress, the penalties and the fines sh ould be 
proportionate to the actual performance. Article 71 stipulates a fine of up to 2% of its total worldwide 
annual turnover, which we believe is higher than is appropriate. China recommends reassessing and 
resetting the penalties.  
2.126.   For article 5.2 in A nnex VII, it is recommended to clarify the scope of the "necessary 
information " to be shared by the provider; for the sake of providers' legal certainty. Besides, we 
request to extend the transition period for 48 months. Providers need to wait for the publ ication of 
the harmonized standards before they can carry out the ex -ante conformity assessment mentioned 
in Title II, Chapter 2. It usually takes more than 36 months for standards bodies to lay down new 
standards, and another 12 months for providers to ad just products and systems, conduct conformity 
assessments and prepare all required documentation. The given transition period of 24 months in 
this regulation is not enough.  
2.127.   In response, the representative of the European Union  provided the following statem ent. 
The EU would like to thank China for continued interest in this measure as well as for uploading its 
statement in the eAgenda so as to allow the EU to prepare a meaningful reply. With regard to the 
Article 43.3, the EU would like to indicate that arti cle specifically clarifies the procedures to be 
followed for high -risk AI systems covered by Annex II.A. In particular, it requires the provider to 
follow the relevant conformity assessment as required under those legal acts. It also specifies that 
where t he legal acts listed in Annex II, section A, enable the manufacturer of the product to opt out 
from a third -party conformity assessment, provided that that manufacturer has applied all 
harmonized standards covering all the relevant requirements, that manuf acturer may make use of 
that option only if he has also applied harmonized standards or, where applicable, common 
specifications referred to in Article 41, covering the requirements set out in Chapter 2. Title High 
Risk AI Systems.  
2.128.   The penalty system in the notified draft follows the model of the New Legislative Framework 
system but also of other existing legislation, such as the General Data Protection Regulation (GDPR). 
This implies that member States remain responsible for laying down the rules on pena lties, including 
administrative fines, applicable to infringements of the notified draft. However, some harmonization 
elements are provided, e.g. on the capping and types of infringements associated. The reference to 
the "total worldwide annual turnover" i s consistent with already applicable legislation in the field of 
data protection (GDPR). While 2% is the maximum capping for the supply of incorrect, incomplete 
or misleading information to notified bodies and national competent authorities, it is up to th e 
member States to foresee in their national laws the amount applicable to the relevant infringement. 
Finally, the EU takes note of the request on the transition period although it notes that it considers 
the transition period sufficient for the industry t o adjust to the new legislation. The EU would like to 
thank the Chinese authorities once again for providing comments on the notified draft and hopefully 
these additional responses sufficiently clarify the points raised.  
2.1.3.11   China - Recommended National Standa rd (GB/T) for Office Devices (Information 
security technology – Security specification for office devices) (ID 76134) 
2.129.   The representative of Japan  provided the following statement. As Japan has pointed out at 
various meetings of the Committees, Japan has heard that the proposed national standards require 
 
33 For previous statements follow the thread under ID 736 . 
34 For previous statements follow the thread under ID 761 . G/TBT/M/89  
 
- 33 - 
 
  office devices including their components procured by critical information infrastructure operat ors to 
be developed and manufactured in China, and also require information disclosure to prove that the 
development and production are carried out in China. As pointed out at the last TBT Committee 
meeting, if national standards including the above requir ements are introduced and are enforced on 
a de facto basis, importation and use of finished products and components of multifunctional 
printers, etc., will not be allowed, and the use of components made in China will be forced. Therefore 
there are concerns  that foreign products including Japanese products will be discriminated against 
and that trade will be restricted unnecessarily. This may violate Articles 2.1, 2.2, and 5.1.2 of the 
TBT Agreement, Article 2.1 of the TRIMS Agreement, and Article III.4 of t he GATT. There is also a 
concern that it could violate Article 7.3 of China's WTO accession protocol if, for example, the specific 
operation of the National Standard could force the transfer of technology in order to manufacture 
office devices in China.  
2.130.   In addition, China stated "there are no plans to revise the Recommended National Standards 
related to printers and copiers in the near future." at the previous Market Access Committee meeting 
last October. However, only one week later, the National Informati on Security Standardization 
Technical Committee (TC260), which is in charge of the draft National Standards, notified that the 
planning process for the National Standards had been completed on 30 October 2022. Japan 
understands that the process for revisio n is still ongoing under the direction of TC260. Japan would 
like China to share the information regarding the schedule of revision of the National Standards 
including the timing for public comment, the scope of application of this National Standards inclu ding 
the definition of critical information infrastructure operators, the requirements for the development 
and production of office devices and their components in China, and the requirements for information 
disclosure to prove that they were developed and  manufactured in China. Furthermore, China stated 
"this is an issue related to standards and should be discussed in the TBT Committee," at the last 
TRIMs Committee meeting, but if China does not provide a convincing explanation of the specific 
concerns rai sed by Japan and related countries at successive TBT Committee meetings, and these 
concerns are not resolved before the public comment, it would be considered that China's 
commitment to the authority of the WTO, which is at the core of the multilateral tra de system, is 
not fulfilled. In order to avoid such doubts, Japan hopes that the concerns raised at this meeting will 
be firmly addressed before the public comment. Japan strongly requests China not to amend the 
draft of the national standards, which conta ins the discriminatory treatment of foreign products and 
the possibility of causing de facto forced technology transfer, in a form causing such matters of 
concern. Besides, Japan strongly urges China not to take the same or similar measures in other 
indust rial sectors or products.  
2.131.   The representative of the European Union  provided the following statement. The EU would 
like to echo the concerns raised by Japan regarding the draft Chinese recommended national 
standard for office devices. Based on the informati on received about the revised requirements, if 
enacted, they would rule out the possibility for overseas office device providers to participate in 
government procurement in China, as most of their products rely heavily on overseas components. 
The EU would like to emphasise that all office equipment cannot be classified as critical information 
infrastructure. This highlights even more the urgency of having a clear and specific definition of 
"critical information infrastructure operator ". The EU also urges Ch ina not to take similar measures 
in other sectors or products.  
2.132.   In response, the representative of China  provided the following statement. This standard is 
currently under application for revision and the notice for its revision application was published on  
22 December 2022. So far, no objections have been received. The revision of these national 
standards is still waiting for the approval of the Standardization Administration of China. The 
formulation and revision of China's national standards are always ba sed on the principle of openness 
and transparency. After the standard revision plan is officially approved, relevant information will be 
released to the public. All parties can obtain this information through the website of the 
Standardization Administrati on of China.  
2.1.3.12   France - Decree on the minimum proportion of re -used packaging to be placed 
on the market annually, G/TBT/N/FRA/223  (ID 75835) 
2.133.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Decree on the minimum proportion of re -used packaging to be placed on the market 
 
35 For previous statements follow the thread under ID 758 . G/TBT/M/89  
 
- 34 - 
 
  annually, notified by the Government of France to the Members of this Committee on 3  March  2022 
through document G/TBT/N/FRA/223 . The Government of Mexico also refers to Offic ial 
Communication No.  500/RVL/058/2022, sent during the public consultation period for this measure, 
identifying the possible impact of the measure on tequila exports.  In this regard, we would like to 
reiterate the main concern in that communication:  The m easure would directly affect exports of 
tequila since, under domestic law, the beverage must be bottled at origin to guarantee its source 
and ensure compliance with the relevant health standards.  
2.134.   The delegation of Mexico kindly requests the delegation of F rance:  To clarify the scope of 
the products covered by the Decree.  We also kindly request a response to the questions contained 
in Official Communication No.  500/RVL/058/2022, in which the Government of Mexico sent 
comments on the measure during its public  consultation period.  Lastly, we ask to be informed of the 
status of the Decree.  The delegation of Mexico thanks the delegation of France for giving its 
consideration to this statement and the requests made therein.  
2.135.   The representative of Australia  provided  the following statement. Australia thanks the EU for 
their response in November 2022 meeting, advising the decree applies equally to products produced 
domestically in France and imported products. Recognizing 2023 is the first year the decree is 
entering into force, Australia thanks the EU for their commitment to enforcing this decree with a 
flexible and educational objective in mind. This will be important to ensure industry adapts smoothly 
to the changed conditions. Australia would appreciate further det ail on the implementation of the 
decree. In particular, noting the decree provides for obligations to be transferred to an eco -
organisation, we request further information on whether the obligations imposed by these 
requirements would be greater for import ed products than for products produced domestically.  
2.136.   The representative of Argentina  provided the following statement. According to the 
notification made in March 2022, the Decree establishes the obligation to recycle a certain 
percentage of containers and  packaging, increasing over time, in order to reduce waste and move 
towards a circular economy. Accordingly, deadlines and procedures are established for those within 
the supply chain to organize themselves to comply with this obligation.  At the last meeti ng of this 
Committee, the EU noted that the Decree applies equally to containers produced in France and to 
imported containers. In this regard, Argentina wishes to express concern and consult France on the 
scope of the Decree in relation to imported produc ts, on how it intends to apply it to these products, 
and whether this would not be an extraterritorial application of a provision aimed at reducing waste 
and carrying out recycling to protect the EU environment.  Moreover, it would be important for 
Argentin a to know whether this regulation is consistent with the packaging provisions being adopted 
by the EU.  
2.137.   In response, the representative of the European Union  provided the following statement. 
The EU would like to thank Mexico, Australia and Argentina for th eir comments on this notification. 
To answer the practical questions first. The decree was adopted on 8 April 2022, and started to apply 
as of the beginning of this year in France. In my answer I will focus on tequila bottles from Mexico 
but I hope that th e logic of the answer is equally valid for Australian wine and Argentinian wine, if 
not I am happy to follow up on a bilateral level. Regarding the re -use of tequila bottles, the EU would 
like to provide the following reassurances to Mexico. Under the Fren ch Decree, tequila bottles would 
be considered household packaging. It is important to be conscious that in France, household 
packaging has been subject to an extended producer responsibility scheme since 1992. Thus the 
producers of this packaging, i.e. na tional producers and importers, are required to finance the end -
of-life of their packaging which includes the collection and processing of the waste either themselves, 
or by joining an eco -organization who will take over the extended producer duties. In pr actice, we 
see that in France there are no producers of household packaging who manage the recollection of 
their packaging waste themselves. All producers of such waste are a member of an eco -organization 
(for example, Citeo or Léko).  
2.138.   In such case, the Dec ree states that the obligation to place reused packaging on the market 
is transferred from the individual producer to the eco -organization. Thus, in practice, it is the eco -
organizations in the household packaging sector that are required to take the neces sary steps to 
achieve the objectives of placing reused packaging on the market, which are then applicable to all 
packaging. In practice this entails that a Mexican producer of tequila will not be asked to set up its 
own recollection system of empty tequila  bottles with as aim to refill these bottles in Mexico with 
new tequila. In principle, being a member of an eco -organisation - as the individual tequila importers 
should already be – should suffice to respect the obligations stemming from the French Decree . The G/TBT/M/89  
 
- 35 - 
 
  EU hopes that this answer is useful and for any follow -up questions we are happy to follow up 
bilaterally.  
2.1.3.13   Canada - Proposed Prohibition of Certain Toxic Substances Regulations, 2022, 
G/TBT/N/CAN/673  (ID 75336) 
2.139.   The representative of Japan  provided the following statement. We appreciate the following 
comments made by Canada at the last TBT Committee meeting. The Regulations aim to reduce the 
risk of toxic substances e ntering the Canadian environment, contributing to the protection of 
Canada's environment and wildlife. Canada published the screening assessment for DBDPE in 2019 
and concluded that DBDPE has a risk of harm to the environment due to its persistence and 
widespread occurrence in the environment along with the potential for bioaccumulation and the 
toxicity of its transformation products. However, Japan continues to have concerns, especially in 
relation to impacts on industries and citizen's lives in Canada, re garding the proposed DBDPE 
restriction in the Proposed Prohibition of Certain Toxic Substances Regulations, 2022. DBDPE is 
widely used in electrical and electronic equipment, automobiles, aircraft, medical equipment, 
industrial equipment, social infrastruc ture equipment, agricultural machinery, industrial machinery, 
construction machinery and industrial vehicles. DBDPE is an alternative to decaBDE, which is a 
globally banned brominated flame retardant, and DBDPE has not been restricted by international 
conventions or in other jurisdictions.  
2.140.   In addition, since there is no equivalent flame retardant for many applications that can be 
used as a substitute for DBDPE at the moment, their prohibition will likely have significant and 
serious effects on the trade and  distribution of the above equipment in the case that the use of 
DBDPE is prohibited. In particular, because of potential impacts on important instruments that 
support industries and the citizen's lives in Canada such as medical equipment, industrial equip ment 
and transport equipment, it is considered that the examination to discover alternatives to DBDPE 
and set an appropriate grace period need to be carried out particularly carefully, by carrying out 
additional hearings from stakeholders for example. Cana da cited the protection of endangered 
whales and belugas as the main reason for regulating DBDPE and we understand the objectives of 
the policy. However, we have been informed by Japanese industries that DBDPE contained in articles 
poses a very low risk of  adverse effects on humans and the environment, including on those 
endangered species.  
2.141.   In relation to this, the screening assessment published by Environment and Climate Change 
Canada elaborates that DBDPE has a very low volatility and that the exposure to  the environment is 
very low from DBDPE contained in articles. It would be appreciated if Canada would indicate the 
rationale for including DBDPE contained in articles in the scope of the Regulations. Therefore, in 
order to ensure that the proposed DBDPE r estriction would not be more trade restrictive than 
necessary to achieve its legitimate objectives, Japan would like to request that Canada undertake 
the following: 1) conduct a more thorough risk assessment of the effects of DBDPE contained in 
articles on  human health and the environment, while taking into account the consistency with results 
of risk assessments from other countries and regions; 2) conduct a realistic feasibility study on 
alternatives to DBDPE; and 3) maintain flexibility in considering wh ether to introduce the DBDPE 
restriction, and ensure that any introduction schedule includes an appropriate grace period based 
on the risk assessment and the feasibility study.  
2.142.   The representative of the Republic of Korea  provided the following statement. K orea supports 
the concerns raised by the delegation of Japan regarding Canada's "Proposed Prohibition of Certain 
Toxic Substances Regulations," which were notified to the WTO Members on 18 May 2022 as 
G/TBT/N/CAN/673 . Regarding the proposed regulati ons, Korea submitted comments on 21 July 2022 
via the Canadian TBT Enquiry Point and received an answer on 22 August 2022. Though we thank 
Canada for this sincere answer, related industries in Korea remain concerned about the proposed 
restriction of DBDPE and as such, Korea would like to convey the following requests. Due to its cost -
effective and excellent flame -retardant features, decabromodiphenyl ethane, or DBDPE, is used as 
an intermediate material in various industrial sectors such as in the manufactu re of electrical and 
electronic products, automobiles, construction equipment vehicles, agricultural machinery, etc., 
substituting the once commonly used decaBDE. Korea shares the view with Canada on the need for 
environmental protection measures. However,  if the restriction on DBDPE is enforced without 
considering the availability and development of alternatives to DBDPE, it is deeply concerned that 
 
36 For previous statements follow the thread under ID 753 . G/TBT/M/89  
 
- 36 - 
 
  such measures would not only be more trade -restrictive than necessary but also put human safety 
at risk. The  proposed regulations include specific time -limited exemptions for electrical and electronic 
products, vehicle parts and pellets or flakes used in manufacturing wires and cables. However, if no 
adequate alternatives were found even after the exemption peri od is over, consumer safety risks 
would increase significantly due to the absence of flame -retardants or the low flame -retardant 
quality in products.  
2.143.   Therefore, Korea requests that Canada thoroughly reconsider product safety before 
enforcing the DBDPE rest riction and give suggestions for manufacturers on the alternatives on par 
with DBDPE in terms of performance and cost. Also, we request that Canada postpone the 
regulations indefinitely until such DBDPE alternatives are developed. In addition, the Departme nt of 
Environment and Climate Change Canada (ECCC) concluded that DBPDE is harmful to marine life 
such as orcas and belugas on the basis that DBDPE acts as a substitute for the decaBDE by the same 
flame -retarding principle. However, the two substances have  different chemical structures, and the 
Canadian government's findings differ from those of international research, such as a study from 
the National Academy of Sciences (NAS) that classifies DBDPE and decaBDE into different sub -
classes of flame -retardants . Accordingly, the U.S. Environmental Protection Agency (EPA) and the 
European Chemicals Agency (ECHA) do not implement risk assessments or risk management 
measures on DBDPE currently, and the Stockholm Convention and the Great Lakes Water Quality 
Control Convention (GLWQA) have not designated DBDPE as a prohibited substance. Moreover, 
Canada has also noted in its Chemicals Information Sheet that DBDPE is not harmful to human 
health. Therefore, to help manufacturers clarify the issue, Korea requests Canada for internationally 
accepted and scientifically justified evidence that DBDPE and decaBDE are equal hazards, besides 
the studies cited in the proposed regulations.  
2.144.   In response, the representative of Canada  provided the following statement. The proposed 
regulation aims to reduce the risks of toxic substances entering the Canadian environment, 
contributing to the protection of Canada's environment and wildlife. The proposed regulation would 
repeal and replace the Prohibition of Certain Toxic Substances Regula tions, 2012, which prohibit the 
manufacture, use, sale, offer for sale and import of certain toxic substances and products containing 
them, with a limited number of exemptions. On 14 May 2022, Canada published in Part I of the 
Canada Gazette, the Proposed Prohibition of Certain Toxic Substances Regulations, 2022. Publication 
of the proposed Regulations opened a 75 -day comment period for stakeholders. The measure was 
notified to the WTO TBT Committee on 18 May. We appreciate the comments received by Japan an d 
Korea. Canada is carefully reviewing and analysing all public comments received during the comment 
period, in consideration for the development of the final regulations. With respect to DBDPE, the 
proposed Regulations provide time -limited exemptions for parts and products of certain industrial 
sectors, such as the automotive sector, and electronic and electrical equipment. Comments and 
concerns from all stakeholders with respect to the proposed controls for DBDPE are being considered 
in the development of  the final Regulations to be published in late 2023.  
2.1.3.14   Argentina - Decree Implementing Law No. 27.642 on the Promotion of Healthy 
Eating, G/TBT/N/ARG/435 ; G/TBT/N/ARG/435/Add.1  (ID 77237) 
2.145.   The representative of Costa Rica  provided t he following statement. Costa Rica wishes to 
raise this trade concern in support of a systemic defence of the principles of the TBT Agreement, 
specifically those relating to: 1 - the adoption of measures based on scientific evidence; and 2 - the 
harmonizat ion of rules through the use of regulations issued by the international reference 
organizations.  Costa Rica once again emphasizes the importance of harmonizing food labelling 
schemes on the basis provided by international reference organizations, such as t he Codex 
Alimentarius and its existing regulations such as the Guidelines on Nutrition Labelling CXG 2 -1985, 
Annex 2, adopted in 2021.  The lack of harmonization of food labelling regulations leads to the 
proliferation of schemes with different content perc entages for requiring a warning, resulting in 
unnecessary barriers to trade.  To date, the Codex Alimentarius has not defined percentages of sugar, 
fat or other content above which consumers must be warned through labels with stop signs or black 
stamps inte nded to discourage consumption of the product.  Costa Rica undertakes to maintain an 
open dialogue between both countries' delegations to the WTO, with the aim of exchanging 
communications and information relating to the new Argentine regulation.  
 
37 For previous statements follow the thread under  ID 772 . G/TBT/M/89  
 
- 37 - 
 
  2.146.   In respons e, the representative of Argentina  provided the following statement. We 
appreciate Costa Rica's interest in Law No. 27.642 on the promotion of healthy eating.  In Argentina, 
the enactment of Law No. 27.642 was the result of a lengthy democratic process, wit h extensive 
discussion in both houses of the National Congress, where industry, academia and civil society had 
the opportunity to present their positions. In the framework of the committee discussions, where a 
great deal of relevant scientific evidence was  circulated, parliamentary decisions were taken. 
Similarly, during the drafting process for the Regulatory Decree, different sectors were involved and 
had the opportunity to make suggestions.  This Law, which was the product of a comprehensive 
legislative d iscussion, with the participation of all sectors involved, clearly states that the Pan 
American Health Organization (PAHO) Nutrient Profile Model should be used.  Regarding the nutrient 
profile, we should first point out that the PAHO nutrient profiling sys tem (NPS) is based on the 
nutritional recommendations of the World Health Organization (WHO) for the consumption of the 
nutrients assessed. The Food Guidelines for the Argentine Population (GAPA) are based on the same 
international recommendations that sta te that the nutrient profile models should complement and 
support food -based dietary guidelines in the region where they are applied.  In this regard, 
Argentina's Ministry of Health conducted an investigation that evaluated the level of concordance 
between NPSs used under different regulations in and outside the region with the national 
recommendations made in the GAPA. The PAHO NPS had the highest overall degree of concordance 
and, when conducting an overall assessment of each NPS, the PAHO/WHO model perfor med the 
best, corresponding to the national scientific evidence available to date.  
2.147.   It follows that Argentina considers that this nutrient profile is the best option for assessing 
the food marketed in our country.  It is important to mention that in recent y ears essential population 
studies were published in our country that allow for a closer characterization of the epidemiological 
situation relating to nutrition and food. This is characterized by ever -increasing consumption of ultra -
processed products and a n increase in malnutrition rates, especially through excess, in all social 
groups.  The excess consumption of critical nutrients regulated by labelling is associated with 
increased cardiovascular and cerebrovascular diseases, obesity, diabetes, cancer and h ypertension, 
among others, which are the cause of most deaths in Argentina each year. At the same time, 
excessive consumption of these nutrients is associated with the consumption of ultra -processed and 
processed products containing excessive amounts of su ch nutrients as set out in the PAHO/WHO 
Nutrient Profile Model.  Studies carried out in 10 countries, including Argentina, also concluded that 
the consumption of products containing excess critical nutrients according to the PAHO/WHO 
definition (which has b een adopted by the Law and its regulations in Argentina) is associated with 
significant non -compliance with WHO recommendations on the intake of these nutrients.  Lastly, we 
emphasize our readiness to continue engaging bilaterally with the delegation of Costa Rica.  
2.1.3.15   European Union - Draft Commission Regulation laying down ecodesign  
requirements for mobile phones, cordless phones and slate tablets pursuant to Directive 
2009/125/EC of the European Parliament and of the Council, G/TBT/N/EU/918  (ID 
76838) 
2.148.   The representative of China  provided the following statement. China supports the EU's 
requirements on eco -design of mobile phones and tablets, but in accordance with Article 2.2 of the 
TBT Agreement for not creating unnecessary trade barriers, China would like to raise the following 
suggestions. First, China would like the EU to re quire the provision of spare parts of folding screen 
protective film only to professional maintenance personnel and withdraw the requirement of 
providing spare parts and replacement of folding screen protective film to consumers. Compared 
with ordinary mob ile phone film, folding screen protective film is more sticky and difficult to operate 
and repair. If dust particles are mixed in the process of pasting protective film, it will be more harmful 
to the screen. Second, China would like to remind the EU that disassembly and replacement of 
battery should be carried out by professional repairers in workshop environment. Smartphone and 
tablets belong to precision devices. For better user experience and longer standby time, flexible 
packaging design is generally a dopted for batteries to fit the irregular space inside the equipment. 
On the one hand, the distance between the positive and negative electrodes of the battery is small, 
so the static electricity of human body during maintenance and replacement and other m isoperation 
may cause potential safety hazards such as fire and explosion, or damage to other spare parts. 
Therefore, battery maintenance and replacement require the repairer to have certain ability in 
electrostatic (ESD) protection environment.  
 
38 For previous statements follow the thread under ID 768 . G/TBT/M/89  
 
- 38 - 
 
  2.149.   Third, Chi na would like the EU to require that only "display assembly and battery" be 
provided to professional repairers as spare parts. Large numbers of use cases show that only the 
display assembly and battery are spare parts with a high replacement rate in mobile  phones and 
tablets, and the replacement rate of other parts is low. The burden of providing other spare parts of 
low replacement rate would not only bring unnecessary costs to manufacturers but also bring large 
amounts of electronic waste to the EU market . Four, China would like the EU to reduce the waterproof 
and dust -tight requirements on mobile phones and tablets. The current waterproof requirements of 
IP67 set out in the regulation are stricter than necessary and do not match the daily use of 
smartphon es. Consumers need to bear extra costs for unnecessary functional design, so it is not 
suitable as the minimum requirement. IP42 could apply instead. For tablets, IP44 set out in the 
regulation does not match the actual usage scenarios, and is not suitable  as the minimum 
requirements. To meet this requirement, consumers need to pay more costs and lose the 
maintainability of products. Besides, under current technological level, certain folding smartphones 
cannot meet the regulatory requirements. Five, the EU  is invited to reduce the requirement on 
resistance to accidental drops and delete the requirement on resistance to accidental drops of folding 
screens in unfolded state. There is a big gap between the number of falls defined in the regulations 
and the act ual usage scenarios. We recommend that the requirements of the regulations should be 
consistent with the actual scenarios and reduce it to 35 falls at a height of 1m. The current regulation 
has no minimum requirement for tablets. For the folding screen mob ile phone, its unfolded size 
(greater than 7 inches) is equivalent to the tablet, which should be consistent with the anti -drop 
requirements of the tablet. It is recommended to delete the minimum anti -drop requirements of the 
folding screen in the unfolded  state.  
2.150.   Six, China hopes that the time limit for security upgrade of operating system could be 
changed to four years after the products are released, and the time limit for function update of 
operating system could be changed to two years after the product s are released. Android system 
updates involve Google, chip manufacturers and OEM; and the continuous provision of security 
updates needs the support of the whole Android ecosystem. According to earlier research by the EU, 
all the 25 Android smartphones am ong Ecodesign preparatory study on mobile phones, smartphones 
and tablets cannot meet the system updates requirements of five years, and still run stably for a 
period of time without system security update. Seven. We hope that architecture analysis, module  
implementation, module test and integrated test can only be executed serially from the 
implementation process. It is recommended that the availability of security updates could be 
extended to six months, and the availability of functionality updates, espe cially system updates, 
could be extended to 12 months. The requirement on the option to restore the operating system 
version which was previously available (System rollback) will introduce unnecessary security risks 
with no value to users. This requirement  is better to be deleted.  
2.151.   Eight, at present, the delivery time of spare parts is affected by the distance between the 
warehouse and the place of order, logistics, the mode of transportation and other restrictions, etc. 
We think the five working days allowe d for the delivery of the spare parts after having received the 
order could be modified to 15 working days, which is consistent with the Ecodesign Directive of other 
products such as dishwashers and washing machines. Nine, China would like the EU to provid e a 
minimum transition period of 24 months for this regulation, and a minimum period of 30 months on 
repair operations. In order to meet requirements regarding waterproof, dust -tight, accidental drops, 
spare parts disassembly, battery endurance and others,  manufacturers need a longer time to 
redesign products and adjust the supply chain, such as prototype testing, mass production testing, 
etc. 
2.152.   The representative of the Republic of Korea  provided the following statement. Korea 
appreciates this opportunity to  make comments regarding the EU's "Draft ecodesign measures for 
mobile phones, cordless phones and slate tablets," notified to the WTO Members on 1 September 
2022 as G/TBT/N/EU/918  and scheduled to come into effect on 6 January 2024. Korea respects an d 
supports the efforts of the EU in adopting the ecodesign requirements to protect the environment. 
Korean companies are also conducting various technological innovation activities to develop eco -
friendly products and provide more value and utility for con sumers. Korea thanks the EU for its 
review and acceptance of some of our previous requests, such as the resistance test criteria to 
accidental drops, that were conveyed via Enquiry Point on 26 September 2022 and at the last TBT 
Committee meeting in Novembe r. Regarding the ecodesign regulation's "Revised proposed text" 
passed at the EU Regulatory Committee meeting on 17 November 2022 and submitted to the EU 
Council in January this year, we would like to request the EU for further consideration as some 
concer ns from the Korean industry still persist or have been newly added. Some of the provisions in G/TBT/M/89  
 
- 39 - 
 
  the revised proposed text stipulate more stringent criteria compared to other ecodesign regulations 
on home appliances, including TVs and refrigerators, hampering  the introduction of new and 
innovative technologies and limiting the consumer's right to choose the latest products and services, 
such as foldable smartphones.  
2.153.   Regarding the latest foldable smartphones, Korea requests that the EU relax the three 
following  technical requirements, which will make it difficult for the manufacturers to achieve 
regulatory compliance or guarantee the product's integrity and safety. Therefore, it is requested that 
the EU (i) Allow the supply of foldable -feature -related spare part s (e.g. the Mechanical display folding 
mechanism, and the Foldable display) not as separate but as an assembly. (ii) Ease minimum criteria 
on the working environment and technical proficiency for ensuring battery replaceability. (iii) Ease 
device dust -tight rating requirement from IP67 to IP47. Also, regarding mobile phones and tablets 
in general, Korea requests for the relaxation of the next three requirements, which will place 
excessive burdens on manufacturers and delay the introduction of new, innovativ e technologies.  
2.154.   Therefore, it is requested that the EU (iv) Extend the maximum delivery time of spare parts 
from within five days to within ten days. (v) Reduce the minimum period for providing OS updates 
or change the reference point from the date of the end of placement on the market to the date of 
placement on the market. (vi) Lower the number of cycles for battery endurance tests to 500 cycles 
while raising the value of remaining capacity to 83% to shorten the verification period. We are also 
ready to c ontinue the discussion with the EU through bilateral engagement and the Enquiry Points 
to address this issue of technical nature in full detail.  
2.155.   In response, the representative of the European Union  provided the following statement. 
The EU would like to th ank the Delegations of the Republic of Korea and China for their continued 
interest in the draft Ecodesign measures for mobile phones, cordless phones and slate tablets 
pursuant to Directive 2009/125/EC of the European Parliament and of the Council. The EU  would 
like to reassure both countries that their concerns have been duly considered: Regarding the folding 
screen protective film, the EU would like to inform both countries that the revised version of the act 
foresees in an altered definition of "protect ive foil", which means "a protective film designed to be 
attached to the display of a foldable device to enhance the reliability and to reduce mechanical wear 
of the screen surface". Regarding the disassembly requirements for batteries, please consider tha t 
the approach laid down in the Regulation for the disassembly requirements of batteries allows for 
the manufacturer to choose between different solutions for his product: either, to comply with the 
requirement that batteries shall be removable by any layp erson with basic tool ("reparability path"), 
or to comply with an alternative requirement that batteries shall be long -lasting, i.e. not having a 
deterioration of more than 20% of their capacity after 1,000 cycles of charge/discharge ("durability 
path"). I n the latter case, the disassembly requirements are less stringent.  
2.156.   Regarding the provision of spare parts, please consider that the revised act has "modulated" 
the maximum delivery time of spare parts: during the first five years of the period referred to  in 
points 1(a) and (c), spare parts are delivered within five working days after having received the 
order; during the remaining two years of the period referred to in points 1(a) and (c), spare parts 
are delivered within ten working days after having rec eived the order. Regarding the tests for the 
resistance to accidental drops of foldable smartphones have also been revised: devices shall pass 
45 falls without any protective foil or separate protective cover, foldable smartphones designed to 
be used with a protective foil on the foldable display shall pass 35 falls in the un -extended state and 
15 falls in the extended state; Note that the Regulation now foresees that the resistance to accidental 
drops is the number of falls which have been passed by at lea st four out of the five units under test 
(before, it was three out five).  
2.157.   On the time limit for security upgrade of operating system, the EU is of the opinion that the 
five years of updates availability (after the date of the end of placement on the market ) will be highly 
beneficial, to the extent of prolonging the lifetime of devices. In fact, the lack of availability of 
software and firmware updates, together with the need for fast/better performing /new devices were 
among the most common replies given by  users when asked for the reasons why their previous 
device was no longer in use (within the public consultation carried out in relation to the initiatives). 
Furthermore, in the revised text security or corrective updates and functionality updates shall be  
available to the user within four months and within six months, respectively. Finally, the latest 
version of the act now foresees that the requirements will enter into application after 21 months 
from the date of entry into force of this Regulation (in th e in the version submitted to WTO, this 
period was of 12 months). We remain available to discuss the measure bilaterally.  G/TBT/M/89  
 
- 40 - 
 
  2.1.3.16   India - Public Consultation for declaring two or more prime constituents of the 
commodity on the front side of the package/Revision of  Legal Metrology (Packaged 
Commodities Rules), 2011 (ID 76539) 
2.158.   The representative of the United States  provided the following statement. In August of 2022, 
the Department of Consumer Affairs, Legal Metrology Division, circulated a public consultation, 
titled: "Inviting Public Consultation for declaring two or more prime constituents of the commodity 
on front side of the package with the Brand Name/ Logo, " which proposed to amend the Legal 
Metrology (Packaged Commodities Rules), 2011.40 We request India noti fy the draft proposed 
amendment to this Committee, provide at least a 60 -day comment period, and take any comments 
received into account before finalizing and adopting the measure. At the November 2022 WTO TBT 
Committee meeting, the United States had quest ions regarding the proposed amendments. We will 
not repeat those questions again for the sake of brevity. India's representatives said they would 
share our concerns with capital and return with answers. We hope they have those answers today. 
In particular,  we would appreciate if India could provide an update on the current status of the 
proposed amendments and we cite the Public Consultation.  
2.159.   In response, the representative of India provided the following statement. We thank the USA 
for their interest in th is issue. The draft was circulated by Indian authorities inviting Public 
Consultation for declaring two or more prime constituents of the commodity on front side of the 
package with the Brand Name / Logo until 31 August 2022. The comments of US -based indus tries 
were also received and under examination The provision is being considered in the interest of 
consumers and is applicable to all the industries viz. indigenous manufacturers and importers.  
2.1.3.17   European Union - Transitional periods for MRLs and internatio nal consultations, 
G/TBT/N/EU/ 682, G/TBT/N/EU/683 , G/SPS/N/EU/360  (ID 58041) 
2.160.   The representative of the United States  provided the following statement. The United States 
again recalls its concerns regarding the European Union's (EU) practi ces related to the enforcement 
and reduction of pesticide maximum residue levels (MRLs). We have noted that EU MRLs and import 
tolerances are often reduced or withdrawn following a non -approval or restricted approval decision. 
The United States continues t o request that the EU complete, in their entirety, its science -based risk 
assessments prior to establishing new MRLs. The United States also asks the EU to provide an 
opportunity in advance of the formal WTO notification comment period for third -country da ta 
contributions. Such an approach will allow the EU to take all available evidence into account, prior 
to making an MRL decision. We have experienced instances where the review of available data is 
only considered after the EU notifies its intention to no t approve a renewal or to approve a renewal 
on a restricted basis.  
2.161.   The United States reiterates its request that the EU retain existing MRL levels while import 
tolerances are under consideration. A recent EU draft regulation now states that it will only co nsider 
import tolerance applications on a case -by-case basis dependent upon meeting its definition of 
"environmental criteria ". Without clear guidance from the EU regarding the parameters of 
"environmental criteria " the proposed new approach lacks clarity and unnecessarily increases 
uncertainty for farmers and growers globally. To prevent food loss and waste and to enhance global 
food security, we request the EU extend the transition periods for MRLs where the EU has not 
identified risks to consumers based on dietary exposure. This will facilitate adequate time for the 
United States and third -country producers to move lawfully produced food products through the 
channels of trade, including products with long shelf lives. The EU's policy of enforcing MRLs at the 
time of importation for imported goods rather than at the time of production, as it applies for the 
EU's domestic goods, is applied inconsistently and causes disruptions in trade for products destined 
for the EU market. Trading partners have found them selves racing to move shipments through 
customs to prevent rejections or turning back orders because a product that previously complied 
with an existing EU MRL at the time of production could potentially be rejected at EU borders. EU 
growers are not requir ed to adhere to the same timelines under the current regulatory provisions, 
 
39 For previous statements follow the thread  under ID 765 . 
40 I-19//42/2022 -W&M, Inviting Public Consultation for declaring two or more prime constituents of the 
commodity on front side of the package with the Brand Name/ Logo" . 
41 For previous statements follow the thread under ID 580 . G/TBT/M/89  
 
- 41 - 
 
  and the United States requests that MRLs for all products, both domestic and imported, be enforced 
based on the date of production.  
2.162.   The representative of Costa Rica  provided the following statement. We reiterate our support 
for this trade concern. As it has done in previous meetings, Costa Rica reiterates its request for an 
extension of the transition periods for compliance with the new tolerances established for 
agrochemicals, approval for the use of which has not been renewed, in view of the impact they have 
on agricultural production in our countries. The usual six -month period is insufficient when replacing 
an agrochemical being used, given the need to assess the possibility of longer transition periods for 
countries that produce and export fruit and vegetables.  
2.163.   The representative of Colombia  provided the following statement. These are topics that we 
have raised in a number of sessions of this Committee and these c oncerns are reiterated on this 
occasion because the requests for adequate transition periods have not been addressed to date, and 
comments expressed in the international consultation process have not been taken into account.  In 
fact, we have had no respons e to our previous questions regarding how the European Union has 
taken account of comments submitted by Members or whether there are cases where regulatory 
changes have been introduced on the basis of the information submitted. We do not know how 
comments have been considered to determine transition periods for the implementation of the rules.  
In addition to these questions that we have raised previously, there are those that we have raised 
in other scenarios regarding the use of emergency authorizations, f rom which producers from the 
EU and from some non -EU countries benefit, but which are not accessible on equal terms for all 
other countries.  
2.164.   Everyone here knows that regulatory changes on the use of plant protection substances, 
coupled with short transitio n periods, create difficulties and uncertainty for fruit - and vegetable -
producing countries, in addition to creating additional burdens for producers who need to make 
decisions on the use of crop protection products one year or more in advance of the arriv al of the 
product on the European market.  In light of the above, Colombia urges the EU to take account of 
the comments made before moving ahead on reducing an active ingred ient to a minimum level of 
detection, particularly where the substances are key for controlling pests or diseases that are typical 
of tropical climates.  We invite the EU to follow the recommendations of good regulatory practices, 
according to which rules should be based on clear and objective information, and open dialogue with 
stakeholde rs, transparency, and reduction of market distortions are promoted.  
2.165.   The representative of Kenya  provided the following statement. Kenya would like to refer to 
her previous statement on this Specific Trade Concern. Kenya continues to support the other 
deleg ations that have raised this issue, since the measure is deemed to be more trade restrictive 
than necessary contrary to Article 2.2 of the TBT Agreement. The transitional periods for MRLs 
established by EU are short and do not take into account the needs a nd adaptive capacities of 
developing countries in contravention of Article 12.3 of the TBT Agreement. The transition periods 
clearly need to be longer. Kenya therefore calls for a review of the transitional periods.  
2.166.   The representative of Canada  provided th e following statement. Canada supports other 
Members' concerns and considers the sudden deletion of maximum residue levels (MRLs) to be 
disproportionate to the level of risk to human health and more trade -restrictive than necessary. 
Canada would like to re iterate its concern with the EU's approach to transition periods for MRLs. 
Canada is of the view that the EU's approach has yet to acknowledge the reality of agricultural supply 
chains such as the time required to ship product, multi -year inventory and ext ensive shelf life, 
including in foreign countries. Sufficient transition periods will allow trade to continue uninterrupted 
while providing adequate time for producers and exporters to adapt to the new EU requirements. At 
a time when ensuring food security  is of high concern, Canada urges the EU to extend transition 
periods for MRLs to third countries, as it has done so for its domestic producers, taking into account 
the need for exporters to adapt to new requirements.  
2.167.   The representative of Paraguay  provide d the following statement. As with other similar 
concerns and as stated in previous meetings of this and other committees, we are concerned that 
the European Union's approach to limiting the use of substances is more trade -restrictive than it 
needs to be f or it to achieve its legitimate objectives under the TBT  Agreement.  The pursuit of such 
policies will cause significant trade damage to the economies of developing countries and jeopardize 
their ability to achieve the Sustainable Development Goals, includi ng those related to food security.  
We urge the EU to reassess its approach and, where MRL reductions are duly justified, provide G/TBT/M/89  
 
- 42 - 
 
  adequate transition periods that take into account the realities of the production processes and 
geographical locations, includ ing distances, of its trading partners.  With regard to international 
consultations, we thank the EU for the notification of measures of this type. However, we reiterate 
our questions regarding how the EU has taken account of comments submitted by Members a t 
different stages of the consultation process and whether there are cases where regulatory changes 
or adjustments have indeed been introduced on the basis of information submitted by those 
concerned in the process since the limited time between the end of  the comment period and the 
approval of the drafts without modifications, which occurs in many cases, leads us to believe that 
these notifications and comment periods are mere formalities and that no account is taken of 
comments or even intended to be take n. 
2.168.   The representative of Ecuador  provided the following statement. Ecuador maintains its 
support for this trade concern raised by the United States, Costa Rica and Colombia, and appreciates 
the inclusion of this specific trade concern on the agenda of this  Committee.  My delegation once 
again reiterates its concern with regard to the procedures relating to the "transitional periods" 
adopted by the European Union for implementing its measures concerning the non -renewal of the 
approval of substances and the re duction of tolerances.  Ecuador's understanding is that, in order to 
establish reasonable transition periods, it is necessary to consider harvesting periods and the times 
when agrochemicals are applied. Farmers need more time to adapt to MRL requirements, a s it takes 
at least 10 years on average to develop or register a new phytosanitary pest -control product, and 
this is when new alternatives have been identified.  
2.169.   It is estimated that around 20% to 40% of the world's crops are lost to pests each year. Of 
that loss, about one third is caused by fungal diseases. Crops such as bananas are particularly 
vulnerable to such pests, which include black sigatoka or, even worse , Fusarium R4T. With the policy 
of prohibiting substances such as imazalil, chlorothalonil, mancozeb and metiram, growers are left 
with no viable alternatives for countering these pests.  In view of the above, Ecuador urges the EU 
to consider an adequate pe riod to enable developing countries to adjust their production to the new 
conditions established in the European regulations. It calls on the EU to consider the comments of 
third countries, particularly when the use of the substances is key for the control  of pests or diseases 
typical of tropical and subtropical climates, conditions that differ from those of the members of the 
European economic bloc.  Ecuador reiterates its request to the EU for information on how it monitors 
that the member State that has r eceived an emergency authorization for the use of prohibited 
substances is complying with the existing MRL regulations and how the EU verifies, in the case of 
non-compliance with the MRL regulations, that the products containing the prohibited substances 
have not been marketed in other EU member States.  
2.170.   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 alterna tive substances, the transition periods granted by the European Union in the 
provisions amending the MRLs for active substances are, in most cases, insufficient in practice for 
making the necessary adjustments to production and ensuring that agricultural p roducts, especially 
processed or frozen products, comply with the new, amended MRLs.  As we have said earlier, six 
months are insufficient for adaptation. In our view, any changes should be gradual, and a reasonable 
period of time should be granted to rais e awareness in the productive sector and among technical 
advisers, and to make available on the market effective substitutes for the active ingredients for 
which the MRLs are to be reduced. It is inappropriate to make drastic changes to the rules in the 
middle of a harvest season, given the impact this may have on the marketing of these products.  My 
delegation reiterates the call for Members to adopt regulatory decisions based on internationally 
accepted standards or to present conclusive scientific evidenc e when it is strictly necessary to deviate 
from those standards to meet their legitimate aims, as provided for in the relevant WTO Agreements.  
2.171.   Uruguay urges the EU, when taking decisions to reduce MRLs for active substances used in 
agricultural production by other Members, to consider the need to grant adequate and sufficient 
transition periods to make the relevant adjustments.  Lastly, Uruguay shares the concerns expressed 
regarding the practical operation of the EU's international consultation process on M RLs, and echoes 
the questions from Colombia and Paraguay on how, and to what extent, the EU has actively taken 
into account the comments of other Members in its regulatory process, and whether it can give 
examples of cases where its original proposals have  been modified in response to comments received 
from third countries.   G/TBT/M/89  
 
- 43 - 
 
  2.172.   The representative of El Salvador  provided the following statement. El Salvador wishes to 
support this trade concern. We echo the comments made by other Members in relation to the concern 
about the imposition of measures to reduce maximum residue levels and the established transition 
periods to comply with the new tolerances being established by the European Union. In that regard, 
we urge the European Union to extend the transition period so that the measures imposed do not 
create unnecessary trade restrictions and are in line with the principles of this Organization. In 
addition, extending these periods would allow small exporting producers to adapt to the regulations 
imposed, takin g into account the type of crop and the substances used, enabling them to be 
competitive at the international level. It is important that these measures fulfil their objective and 
do not distort trade.  
2.173.   The representative of Panama  provided the following st atement. We echo the comments 
made by the delegations that took the floor earlier. As in past meetings, Panama wishes to express 
its concern regarding the transition periods to comply with the new tolerances established. We urge 
the EU to extend the transi tion period to enable small exporting producers to adapt to the regulations 
imposed since the current period is insufficient.  
2.174.   The representative  of Guatemala  provided the following statement. We reiterate the point 
made in previous meetings that the Europe an Union's transition periods are insufficient in practice 
to make the necessary adjustments in this area, in line with production chains and stages. In 
addition, producers require certainty regarding substances, and this should be considered as from 
the entry into force of the MRL changes and not the renewal of the substance. An appropriate period 
is needed for producers to make the necessary changes, and in particular to have time regarding 
the effectiveness of the substances, which is measured according to the different climatic phases 
during the year. We support the questions submitted by Colombia and Paraguay.  
2.175.   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 and July 
2021. The EU considers that measures lowering maximum residue levels due to concerns for human 
health, fall under the rem it of the SPS Committee and should be discussed in that context. On the 
contrary, all measures concerning non -approval or restriction of active substances used in plant 
protection products in the EU and a limited number of very specific measures lowering M RLs due to 
environmental issues of global concern (e.g. clothianidin and thiamethoxam) are notified to the TBT 
Committee. These measures do not have direct consequences on SPS related matters. In the interest 
of transparency and, further to requests by som e Members, when notifying these measures under 
the WTO/TBT notification system, the EU additionally informs the SPS Committee of the submission 
of those notifications. In practice, both Committees are informed about draft acts on the non -
approval or restri ction of approval of an active substance in the EU. However, comments should only 
be submitted via the TBT notification system in those cases. The EU would like to point out in this 
context that the commenting deadlines are always respected and that the co mments received within 
those deadlines are duly taken into account in the EU's decision -making process.  
2.176.   In the interest of efficient proceedings in both Committees and, in line with the respective 
Agreements, the EU would invite Members to raise matters on  approvals of active substances and 
measures dealing with MRLs in view of environmental issues of global concern exclusively in the TBT 
Committee, while matters relating to MRLs for pesticides due to human health concerns should be 
raised exclusively in th e SPS Committee. Issues concerning transitional periods for MRLs should 
therefore generally be raised at the Committee to which the original notification was made, which 
would be, in most cases, the SPS Committee.  
2.177.   The representative  of Uruguay  provided the  following statement. We would like to thank the 
European Union for its response and take note of it. We can see that it is essentially the same as 
the response that was provided on previous occasions. In order to make headway in the dialogue 
on this conce rn shared by several Members, we would simply like to ask the European Union if it 
could, at this meeting or at the next meeting of this Committee, also answer the questions raised 
by Colombia, Paraguay, Uruguay and Guatemala, today, which had already been  raised at several 
previous meetings.  G/TBT/M/89  
 
- 44 - 
 
  2.1.3.18   European Union - Chlorothalonil (pesticide active substance), G/TBT/N/EU/625  
(ID 57942) 
2.178.   The representative of Costa Rica  provided the following statement. Once again, Costa Rica 
supports Colombia's comments and we  refer to previous statements expressing concern about the 
measure notified by the European Union in document G/TBT/N/EU/625 , in relation to the non -
renewal of the approval of the active substance chlorothalonil.  Costa Rica thanks the EU for its 
willingness to hold a dialogue on agrochemicals policy, taking into consideration international 
obligations on foreign trade and the agricultural and environmental policy objectives of the member 
countries of the international community, together with the commi tment to leave no -one behind in 
the implementation of its Green Deal policy.  
2.179.   The representative of Colombia  provided the following statement. Colombia once again 
expresses its concern regarding the measure notified by the European Union regarding the activ e 
substance chlorothalonil.  In fact, despite the technical and scientific comments submitted within the 
consultation periods, the rule preventing the renewal of the marketing of products with this active 
substance entered into force and the European Commission set the maximum residue level or 
minimum level of detection.  It is clear that in this case the EU has also not taken into consideration 
the technical comments submitted or the requests for a longer transition period to adapt production 
processes.  We therefore urge the EU to take account of the productive and social particularities of 
the tropical countries supplying its market. I refer in particular to the fact that reducing the MRL for 
chlorothalonil causes a significant impact on produ cers, putting at risk employment and the economic 
and social stability of whole regions of the country.  The scenario is even worse if account is taken of 
the fact that at the moment there are no substitute or similar plant protection products or any that 
have the same environmental or toxicological profile, since other alternative substances are also 
under review by the EU.  
2.180.   We therefore reiterate the request to the EU to consider pesticide information provided by 
specialized agencies, such as Codex, and to take its decisions on the basis of conclusive scientific 
evidence and the weighting of actual risks in accordance with international principles and standards 
in this area, and to ensure import tolerances.  These measures, in addition to deviating from 
recog nized international standards, are being applied unevenly as, in practice, their implementation 
and authorization for use differentiate between domestic and foreign producers. This is the case for 
emergency authorizations, which allow EU producers to conti nue or resume use of this substance.  
In conclusion, we note that producers and exporters still have concerns regarding the inspection and 
control mechanisms and procedures for demonstrating compliance with the requirements, which 
does not make for predicta bility in foreign trade operations.  
2.181.   The representative of Brazil  provided the following statement. Brazil supports STC 579 and 
refers to its previous statements on the matter. We believe that the EU's decision to base measures 
on a hazard -based approach, w ithout an adequate risk analysis and with no compliance with long -
standing scientific principles is inconsistent with WTO rules. The non -renewal of approval for 
chlorothalonil by the EU did not duly consider that it is currently authorized in more than 100  
countries, and that the MRLs allowed by Codex could reach up to 70 mg/kg. We stress our systemic 
concern with the fact that some hazard -based analyses conducted by the European Food Safety 
Agency (EFSA) led to the non -renewal of approvals of some substanc es 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, citru s fruits, papaya and watermelon, among other products.  
2.182.   The representative of Ecuador  provided the following statement. Ecuador once again thanks 
Costa Rica and Colombia for including this concern on the Committee's agenda and reiterates its 
support for thi s concern regarding the non -renewal of approval for use of the active substance 
chlorothalonil.  Chlorothalonil is mainly used for controlling black sigatoka in bananas, as a fast -
acting fungicide with a multi -site mode of action, meaning that the risk of f ungal resistance is low. 
It should be mentioned that the options for multi -site substances remain scarce as no new 
substitutes have been identified which are not also under review by the European Union, as is the 
case for mancozeb and metiram.  Controlling black sigatoka ( Mycosphaerella fijiensis ) is the main 
 
42 For previous statements  follow the thread under ID 579 . G/TBT/M/89  
 
- 45 - 
 
  challenge for banana production in Latin America. To control the disease, strategies of rotating 
fungicides with different modes of action are pursued to avoid fungal resistance to these compounds.  
2.183.   The climate in Ecuador is tropical, so pests and their behaviour are different from those in 
the EU. Certain active substances and their formulations are indispensable in agricultural production 
to prevent crop losses and resulting harmful economic and social effects.  Therefore, Ecuador urges 
the EU to consider the particular circumstances of tropical countries when implementing the 
measures adopted and to take a more balanced approach in line with the Codex Alimentarius. 
Ecuador understands that for an MRL to be established, banned or lowered there must be conclusive 
scientific information demonstrating a real health impact.  Reducing the MRL for chlorothalonil could 
have a huge impact on the banana sector in my country. This sector makes a substantial contribut ion 
in providing jobs for 2.5 million people. Exports of this product account for a significant share of the 
country's foreign exchange earnings (2.1 billion). This equates to 2% of GDP and 35% of agricultural 
GDP. 
2.184.   The representative of Paraguay  provided t he 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 
in the MRLs. Paraguay the refore refers to its previous statements and requests that its statement at 
the previous meeting be reflected in full in the minutes of this meeting. We once again request the 
European Union to take into consideration information on pesticides provided by the specialized 
agencies recognized by the WTO, such as the Codex Alimentarius, to reconsider its approach, to 
base its decisions on conclusive scientific evidence and real risk weightings, in accordance with 
international standards and principles, and to ensure import tolerances.  
2.185.   Statement from November 2022 meeting.43 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 subs equent reduction in the MRLs. Paraguay 
therefore refers to its previous statements and requests that its statement at the previous meeting 
be reflected in full in the minutes of this meeting. We once again request that the European Union 
take into consider ation 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 intern ational standards 
and principles, and ensure import tolerances.  
2.186.   The representative of Guatemala  provided the following statement. Guatemala remains  
concerned about the use of chlorothalonil and maintains its position with respect to this trade 
concern. We would like reiterate our previous statements. There is no information to date on 
scientific evidence of possible damage by these substances to human health. There is currently no 
compound on the market that is as effective for the control of the Ascochyta fungus, particularly in 
vegetables. Alternative substances that might replace the use of chlorothalonil include mancozeb, 
azoxystrobin, pyraclostrobin, sulphur and difenoconazole. For four of these alternative substances, 
the registrations for marketing we re not renewed in the European Union and therefore MRLs have 
been reduced to almost zero tolerance, leaving Guatemalan agricultural production with no options 
that can effectively combat diseases of fungal origin. We reiterate our concerns and await a prop er 
response from the European Union.  
2.187.   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 
Commission Implementing Regu lation (EU) No 2019/67744, adopted on 29 April 2019 and previously 
notified to the TBT Committee. Following the non -renewal of approval decision, the EU prepared a 
draft Regulation lowering the Maximum Residue Limits (MRLs) for chlorothalonil, which was no tified 
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 to the relevant limits of quantification through Commission 
 
43 G/TBT/M/88 , para. 2.220.  
44 Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning t he non -renewal of 
the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the market and 
amending Commission I mplementing Regulation (EU) No 540/2011. OJ L 114, 30.04.2019, p. 15.  G/TBT/M/89  
 
- 46 - 
 
  Regulation (EU) 2021/15545 of 9 February 2021. The new values are applicable to all food products 
since 2 September 2021. Since then, there has been no further developments in the EU on this 
substance, as no new data were received. Import tolerance requests, which need to be supported 
by substantial new data addressing the concerns, remain possible and will be assessed on a case -
by-case basis by the "rapporteur " member State and  the EFSA.  
2.1.3.19   China - Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61146) 
2.188.   The representative of the United States  provided the following statement. The United States 
remains deeply conc erned with this measure, published as Decree 248 in April 2021, and 
implemented in January 2022. We continue to question the food safety and public health benefits, 
and whether such benefits are based on science or risk. The United States notes that the la ck of 
guidance provided by China, and China's unpredictable implementation and enforcement of the 
measure continue to cause considerable confusion for exporters and competent authorities. The 
General Administration of Customs of China (GACC) should not req uire competent authorities in 
exporting countries to administer China's registration process through its online system or otherwise. 
These administrative actions are fundamentally outside the responsibility of foreign food safety 
authorities, and should be  performed by GACC. The requirement that all facilities exporting food to 
China must provide extensive, detailed information burdens trade and limits consumers' access to 
safe food products, and China still has not explained how this information will be us ed. 
2.189.   China appears to be both relying on foreign competent authority oversight and reviewing 
documentation submitted by individual facilities. This framework establishes redundant reviews of 
products for which China has not identified any risk. Overall, the  system that China intends to 
implement is confusing, appears to be unnecessarily burdensome to achieve food safety, and does 
not appear to be based on the risk of commodities exported to China. As we have noted previously, 
GACC should ensure that all faci lities are able to self -register without foreign competent authority 
involvement or unreasonable information requirements. Finally, we note that GACC's deadline of 
30 June 2023 for firms and competent authorities to complete the registration process is com pletely 
unrealistic. The actions GACC appears to request would take years to complete, if they are even 
possible at all. We request that China indefinitely suspend this deadline to allow trade to continue 
while China addresses outstanding concerns with the se requirements. We look forward to China's 
response to these specific requests and comments.  
2.190.   The representative  of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. Because there is no progress on this STC and the lack of 
transparency continues to be an issue, we would like to reiterate our concerns in the previous TBT 
meetings. Given the wide range of our food industries that have b een or may have been affected by 
this measure, the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu has been 
closely following the implementation of the measure. Many concerns over the measure remain even 
after it took effect on 1 January 202 2. First, the lack of sufficient information about registration 
requirements, operational guidelines, and updates of the stages of the procedure is one of the 
biggest difficulties we face. This issue is even more critical for those facilities that need to file the 
application by themselves. Without sufficient guidance, the facilities are unable to complete 
registration, and trade may be disrupted as a consequence. To avoid trade disruption, an enquiry 
point is needed to provide effective and timely assistan ce for facilities to contact directly with 
concerns about the measure. Also, an information session is necessary so we can learn more about 
the General Administration of Customs of China (GACC)'s implementation of the measure. Second, 
there are also concer ns over the measure's review and approval procedure. Standard or anticipated 
processing periods are unknown. So is the stage of the application. In addition, some of our facilities 
were rejected by the GACC without further explanation.  
2.191.   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 procedure. We request that the GACC comply  
 
45 Commission Regulation (EU) 2021/155 of 9 February 2021 amending Annexes II, III and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum re sidue 
levels for carbon tetrachloride, chlorothalonil, chlorpropham, dimethoate, ethoprophos, fenamidone, 
methiocarb, omethoate, propiconazole and pymetrozine in or on certain products. OJ L 46, 10.2.2021, p. 5.  
46 For previous statements follow the thread under ID 611 . G/TBT/M/89  
 
- 47 - 
 
  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 a mbiguity 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 made notification 
to the WTO in 2020, we h ave 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. We therefore once again urge for sufficient and detailed guidel ines and 
designation of an enquiry point. Also, as any measure of this magnitude requires far more time for 
industries to implement, we would like to echo other Members' call for a longer grace period for 
implementation and temporarily allowing entry of al l products from registered facilities so as to avoid 
serious trade disruption.  
2.192.   The representative of the European Union  provided the following statement. The EU must 
raise this topic again to highlight remaining concerns about the implementation of Decree 248 of the 
General Administration of Customs of the People's Republic of China (GACC). More than a year after 
its entry into force, the EU considers that the whole implementation process of Decree 248 is still 
very burdensome and not transparent. As previo usly mentioned, EU applicants are still facing many 
issues in the registration process, mostly due to recurrent technical problems with the web -based 
registration system (CIFER), making the electronic submission of documents cumbersome, time 
consuming and uncertain, be it to apply for new registrations or to amend or correct existing 
registrations. In this context, EU applicants are concerned with the upcoming deadline of June 2023 
to provide supplementary information for existing registrations. Due to recu rrent technical problems 
with the CIFER system, it is unlikely that all establishments will be able to complete their registration 
on time.  
2.193.   More recently, EU applicants have also faced difficulties regarding the renewals of past 
registrations, with a burde nsome procedure including, first, an application for "modification ", 
followed by an application for "extension ". In order to avoid food trade disruption, the EU urges 
China to: Resolve the technical software problems with the CIFER system; Facilitate the p rocess to 
amend/correct existing registrations; Extend the deadline of June 2023 to provide supplementary 
information on existing registrations; and Simplify the renewal procedure for past registrations. The 
EU would like to thank China for the constructiv e dialogue, which has so far helped to address several 
questions related to implementation of Decree 248, however, important issues remain to be 
resolved.  
2.194.   The representative of India provided the following statement. Through the notification 
G/TBT/N/CHN/1522  China has implemented online China Import Food Enterprise Registration 
(CIFER) system. The registration process in the CIFER system is burdensome, technically onerous 
to comply with and there is lack of any clarity on the compliance process inv olved. In view of these 
trade restrictive measures, we request China to provide greater clarity on the compliance process. 
We also request China to establish dedicated communication channels to deal with any queries 
related to the compliance of this notifi cation.  
2.195.   The representative of Kenya  provided the following statement. Kenya would like to reiterate 
her previous statement on this Specific Trade Concern. Kenya raised this as a Specific Trade Concern 
in the previous TBT Committee meeting and continues to have concerns over the same issue. Kenya 
is concerned that some provisions in the regulation are more trade restrictive than necessary 
contrary to Article 2.2 of the TBT Agreement. Kenya therefore urges China to review these 
regulations, and possibly revis e them to provide among other things, clarity on the scope of their 
application (transparency), and make them less stringent to comply with, i.e. eliminate the need to 
have all imported food and food products to be pre -registered with China's General Admin istration 
of Customs (GACC).  
2.196.   The representative of Japan  provided the following statement. Japan would like to raise its 
concerns again regarding the implementation of Decree 248 by China concerning administrative 
measures for registration of overseas manu facturers of imported food. Japan is concerned that the 
procedures remain uncertain and lack predictability; in particular, frequent, unexpected changes 
have been made to the China Import Food Enterprise Registration (CIFER) system without prior 
notice to the Members. In addition, Japan appreciates China's General Administration of Customs 
(GACC)'s letter dated 27 October 2022 explaining that the overseas manufacturers of certain primary 
edible agricultural products need to be registered via letters/emails instead of using CIFER system. G/TBT/M/89  
 
- 48 - 
 
  However, the details of such alternative procedures have not been made clear, and the procedures 
are uncertain and lack predictability. As a result, the operation of Decree 248 could have a 
significantly negative impact on Ch ina's trade with Japan and other Members. Japan requests that 
China improve the operation of the CIFER system, and make the procedures for implementation of 
Decree 248 transparent, including those for primary edible agricultural products, based on the 
Memb ers' remarks at this and previous TBT Committee meetings.  
2.197.   Specifically, once again, Japan requests that China: (i) Establish a standard processing 
period for applications made through the CIFER system (i.e., a standard timeline to be followed from 
applicat ion through registration), and make that processing period known to the Members and 
foreign manufacturers. (ii) Give sufficient explanation for the reasons when an application is rejected 
through the CIFER system. (iii) Notify the Members promptly of any c hanges in the operation of the 
regulations or the CIFER system, including changes to product codes (HS CIQ) used in the system, 
which will or might affect exports. Should any changes occur, we also ask that the GACC provide a 
reasonable transition period. (iv) Correct any defects in the CIFER system as soon as possible, 
including: (a) the fact that the system does not accept changes to information about the legal 
representatives and addresses of registered manufacturers and does not accept the submission of  
letters of proxy; (b) the current, considerable delays in the registration process; and (c) the fact 
that some of the product codes (HS CIQ) are missing from the list shown on the system. (v) Establish 
an enquiry point for interested parties and competent  authorities, and also hold an information 
session in Geneva for concerned Members regarding implementation of the regulations. (vi) Respond 
to unanswered questions within a reasonable time.  
2.198.   Japan would also like to echo the previous speakers that China sh ould extend the June 2023 
deadline for the submission of additional relevant information for the validity of existing approval of 
establishments falling under Article 7 of Decree 248. Japan thanks China for its prompt attention to 
resolving these issues in  an appropriate and timely manner.  
2.199.   The representative of Australia  provided the following statement. Australia acknowledges 
the difficulties experienced by China in the implementation of the China Import Food Enterprise 
Registration (CIFER) system as part of its roll out of Regulation on Registration and Administration 
of Overseas Manufacturers of Imported Food (Decree 248). Australia appreciates the cooperation 
between the Department of Agriculture, Fisheries and Forestry and the General Administration of 
Customs of China (GACC) to work through the many system issues being experienced in the CIFER 
system. We remain willing to continue to work with China to minimise trade disruptions. Australia is 
concerned at the resource -and-labour -intensive costs borne by  exporters and exporting countries' 
competent authorities to comply with registration in the CIFER system. This burden is exacerbated 
by the number of technical issues, delays and lack of clarity experienced within the CIFER system, 
with competent authorit ies having to verify data and evidence supplied.  
2.200.   Australia encourages China to provide: Reasonable timeframes for assessing, re -evaluating 
and adjusting applications in the CIFER system; notification of updates to the system competent 
authorities. Transpar ency in: evidence required to support applications, and the acceptance of official 
verification of documentation for its intended purpose; provision of appropriate guidance (including 
instructional materials), assistance and resources to enterprises and tr ading partners' competent 
authorities in meeting China's registration processes. A guarantee of continuity of trade to all 
currently registered establishments until the IT system issues in China are resolved. Equal 
opportunity for access to application mod ules of, and application assessments for, all establishments 
registered in CIFER. For example, establishments registered in CIFER, if suspended by GACC, do not 
have the functionality in their profiles to submit applications for extension and therefore are not 
given the opportunity to apply to extend their registrations before they expire.  
2.201.   Australia reminds China that its regulations must not discriminate against imported goods. 
Delays in processing registration renewals, lifting suspensions and approving ne w applications from 
overseas food producers, must not lead to imported foods being treated less favourably than China's 
domestic product. Australia encourages China to work with competent authorities and food facilities 
to conduct audits as described in De cree 248 in an informed, sustainable and equitable manner.  
2.202.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea echoes the concerns raised by US, Chinese Taipei, EU, India, Kenya, Japan and Australia 
under thi s Specific Trade Concern. Korea respects China's efforts to ensure the safety of its 
consumers from risks caused by food products, and appreciates its continued cooperation through G/TBT/M/89  
 
- 49 - 
 
  bilateral channels. However, Korea remains concerned since China's measures  still include low -risk 
food products provided in Article 7 of Decree 248, which is creating unnecessary obstacles to trade. 
While Korea is registering newly added product categories in accordance with GACC's requirements, 
it is taking a significant amount  of time for the registration to finalize. Moreover, some facilities are 
rejected without explanation, leading to a negative impact on trade.  
2.203.   Korea also requests China review the registration standard, to consider basing it on the 
individual manufacturing facilities, instead of the product categories. The current requirements are 
resulting in inefficiency, such as having to apply for each category the facilities wants to register and 
having to submit duplicate data, as facilities are required to apply for r egistration based on product 
categories. In order to process the registration applications as swiftly as possible, Korea requests 
China change the registration standard to the manufacturing facilities, from the current product 
categories, and to utilize pr eviously reviewed data, so that registered facilities can be allowed to 
export all of their products. Additionally, obligating facilities to register food products that are clearly 
labelled as a free sample that is not sold or consumed is a measure that hi nders mutual growth of 
Korean and Chinese food industries. Many other countries do not apply such measures to sample 
products, and Korea therefore requests China ease related regulations. Korea would like to remind 
China that all WTO Members have the oblig ation to implement food safety regulations based on 
sound scientific basis and transparency. As the new measures would significantly affects bilateral 
trade, Korea would like to ask China to provide a response to our statement.  
2.204.   The representative of Switze rland provided the following statement. Switzerland follows this  
matter with interest and supports the concerns raised by other Members.  
2.205.   The representative of Brazil  provided the following statement. Brazil would like, once again, 
to support STC 611 rega rding new requirements for the registration of overseas producers of 
imported foods. The Chinese government has not yet clarified the risk analysis that grounded such 
disproportionate requirements for a wide range of food products. We understand that these  
requirements constitute unnecessary obstacles not only to our private sector, but also to our 
regulators, which must operate as the Competent National Authority for a much wider range of 
products. Not only are the regulators facing an unreasonable increas e in their burden, but some of 
them must also make recommendations on products or producers that are actually subject to 
inspection by authorities of other levels of government. 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 management of the safety of imported 
and exported food.  
2.206.   Article 5 of Decree n. 248 requires that the food safety management system of the c ountry 
where the producer is located has passed GACC's equivalence assessment or review. Could China 
explain how and when it intends to carry out these assessments? Could China indicate the criteria 
and procedures used to establish such equivalence, especi ally for regulators of processed foods and 
"health foods "? 
2.207.   In response, the representative of China  provided the following statement. China would like 
to inform Members that the content of the revision is legally based, and the process is open and 
transpar ent. In order to effectively implement the provisions of the Food Safety Law of China and 
its Implementation Regulations and other related laws and administrative regulations, GACC revised 
the Provisions on the Registration and Administration of Overseas E nterprises Producing Imported 
Food (hereinafter referred to as the Provisions), which was published on 12 April 2021 and officially 
implemented on 1 January 2022. Before announcing the regulations, China notified members and 
received comments therefrom. Re asonable comments have been fully taken into consideration. We 
also set a reasonable transitional period as required by the TBT/SPS Agreement. While aiming to 
strengthen food safety supervision, the regulations also give full consideration to trade facilit ation. 
The revised Provisions extend to all categories of food stipulated in the Food Safety Law. Based on 
the analysis of factors such as raw material source, production and processing technology, food 
safety historical data, consumer groups, eating metho ds, and so on, and in line with international 
practices, the "official recommendation registration" mode is adopted for overseas producers of 18 
types of food. Members shall audit and inspect the enterprises they recommend for registration and 
confirm that  they meet the registration requirements. For overseas producers of foods other than 
the 18 categories, the mode of "application by enterprises" with relatively simplified procedures is 
adopted. They can apply for registration and submit application materi als to GACC by themselves or 
by entrusted agents.  G/TBT/M/89  
 
- 50 - 
 
  2.208.   In order to ensure the implementation of the regulations, GACC has published the 
interpretation of the regulations, the Guide for registration and applications, the supporting 
documents and forms for regist ration and applications, and launched the overseas enterprise 
registration information system with the system operation manual. GACC has actively contacted 
Members that have food trade with China, informed overseas enterprises of relevant requirements 
and procedures for registration, taking into full account the existing food trade situation, and made 
reasonable arrangements such as speeding up the examination and registration of overseas 
enterprises. Through various means of communication with competent de partments of members on 
the implementation of the regulations, GACC has up to now organized training sessions for over 
2000 overseas enterprises. By 28 February 2023, authorities of more than 100 countries and regions 
had provided GACC with a list of enter prises recommended for registration, a total of 82,000 
overseas manufacturers of 32 categories of products have been registered. Up to now, GACC has 
conducted briefings for foreign embassies and consulates of 152 countries (regions) in China and 
overseas c ompetent authorities to clear doubts and concerns and established "point -to-point" 
contact with some Members. At present, the implementation of the measures and food trade with 
China go smoothly.  
2.1.3.20   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manu al of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA (ID 61847) 
2.209.   The representative of the European Union  provided the following statement. The European 
Union (EU) appreciates that Peru further extended the possibility for imported products  to use 
stickers for compliance with labelling requirements for processed foods, until 30 June 2023. 
However, the EU would like to repeat once again the urgent invitation to Peru to provide for a 
permanent possibility for imported products to use stickers.  The repeated and unforeseeable 
extensions of the deadline severely disrupt trade because retailers in the Peruvian market stop 
buying products with stickers several months before each deadline. Such disruptions represent 
significant losses for importers a nd producers, as well as disruption of trade flows and unavailability 
of the affected products in the Peruvian market. The EU recognises that reliable information to the 
Peruvian consumer and protection of public health are legitimate objectives. Neverthel ess, the 
obligation to print information on the product package is unnecessarily trade -restrictive and 
represents a disproportionate burden for foreign producers, in particular SMEs. In the EU and in 
most countries around the world, stickers are allowed fo r food products, provided that the 
information is accurate and the stickers are not easily removable. In this respect, the EU also notes 
that other Peruvian instruments, such as Supreme Decree No. 007 -98-SA adopting the regulations 
on sanitary surveillance  and control of food and beverages, allows for the use of stickers to meet 
labelling requirements, given that this is an appropriate means for the fulfilment of the proposed 
legitimate objectives. We invite once again Peru to bilaterally work with the EU o n this issue.  
2.210.   The representative of Costa Rica  provided the following statement. Costa Rica reiterates its 
trade concern regarding the process of implementing the draft regulation established under Supreme 
Decree No. 015 -2019-SA, which amends the Manual of Advertising Warnings approved by Supreme 
Decree No. 012 -2018-SA of Peru.  Costa Rica thanks Peru for extending the deadline for using 
adhesive labels. However, this temporary solution does not provide our exporters with legal certainty 
and clarity  about the regulations applicable to trade in food in Peru. Progress needs to be made on 
an amendment to the final regulation, which would allow the use of adhesive labels for an unlimited 
period.  It is important to note that the use of adhesive labels is widely recognized internationally, 
as such labels achieve the same public health protection and consumer information purposes 
achieved by permanent labels.  At the CODEX level, for example, Articles 8.1.1 and 8.2.1 of CODEX -
STAN 1 -1985, General 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 in cases where the language on the original label is not acceptable to the 
consumer for whom it is intended.  Costa Rica respectfully requests the Peruvian authorities to 
consider permitting the use of adhesive labels on a reciprocal basis, given that these labels may be 
used on Peruvian food products to be marketed in Central America . We request the Peruvian 
authorities to provide information on the status of this regulation, whether the intention is still to 
ban the use of stickers on labels, and the timing of the regulation's entry into force.  
2.211.   The representative of Colombia  provided  the following statement. Colombia once again 
brings this trade concern to the agenda of this Committee regarding the use of stickers as advertising 
 
47 For previous statements follow the thread under ID 618 . G/TBT/M/89  
 
- 51 - 
 
  warnings.  It has been suggested on previous occasions that the use of adhesive labels is widely 
recognized internationally, as they fulfil the same public health protection and consumer information 
purpose as permanent labels.  In fact, as has also been mentioned earlier, with current technology, 
self-adhesive labels can be printed which do not peel off the pack aging, thereby ensuring that they 
will remain affixed, despite not being printed directly onto the packaging.  Consequently, it is in our 
interest, as well as that of other countries, to use adhesive labels indefinitely.  For Colombia, initial 
trade associat ion estimates indicate that this measure particularly affects small and medium -sized 
businesses that have exported processed foods to Peru, in addition to creating logistical issues 
related to distribution, as establishments generally require compliance wi th standards in advance so 
that at the time of sale to end consumers compliance is guaranteed.  At the same time, this measure 
affects product competitiveness since it increases costs, because producers must install different 
packaging lines or contract thi rd parties depending on the country of export.  Lastly, while we value 
the bilateral talks that have taken place at different levels and the extensions of the period for using 
adhesive labels, a definitive solution would contribute to legal certainty and cl arity regarding the 
regulations applicable to the food trade in Peru.  There is a need to move forward as regards 
amending the final regulation, allowing the use of adhesive labels without a time limit, thereby 
avoiding an unnecessary barrier to trade.  
2.212.   The representative of Brazil  provided the following statement. Brazil regrets having to once 
again express its concerns regarding labeling 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 attached to the packaging 
and if the language of the original label is not necessarily that of the cons umer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that help to better inform consumers. Despite Peruvian legitimate concerns with 
deceptive practices, advances in labelling tec hnologies allow for their safe affixation. We 
acknowledge that, according to Supreme Decree 022 -2022-SA, the entry into force of the prohibition 
on stickers was delayed until 30 June 2023. 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 provisio nal solution and will continue 
to raise this STC until Peru permanently removes its burdensome requirements for food labelling.  
2.213.   The representative of Paraguay  provided the following statement. We thank Brazil, Costa 
Rica, Colombia and the European Union fo r including this trade concern on the agenda and request 
that Paraguay's support be recorded.  As stated at previous meetings, Paraguay supports Peru's 
objective of protecting public health and considers that the provision of information to consumers 
throug h labelling is an appropriate strategy. However, we share and support the concerns expressed 
by other Members with regard to the time limit established for the use of supplementary labels.  It 
should be noted that the use of labels of this kind is widely re cognized internationally, as such labels 
achieve the same public health protection and consumer information purposes achieved by 
permanent labels. Not accepting them is therefore more trade -restrictive than necessary to fulfil the 
legitimate objective.  We regret that once again Peru has decided to extend only temporarily its 
legislation to allow the use of supplementary labels until 30  June this year, this being the fourth 
temporary extension, so we reiterate that temporary extensions do not provide exporte rs with the 
legal certainty they need.  We therefore ask Peru to allow the use of this type of adhesive labels 
indefinitely and to bear in mind the provisions of Article 2.2 of the TBT Agreement.  Considering the 
new assessment by Peru's Ministry of Health r egarding the use of this type of adhesives, when does 
Peru think that it will be concluded? Can Peru share the terms of reference of the study initiated and 
the methodology used?  
2.214.   The representative of Guatemala  provided the following statement. We reiterat e the 
recognition of Peru's right to safeguard and protect the health and life of consumers, while informing 
the public about food content.  Supreme Decree No.  022-2022-SA, published on 31  December  2022 
in the special edition of the Official Journal El Peru ano, extends the deadline to 30  June 2023 for the 
use of stickers with advertising warnings for imported products as provided for in the Manual of 
Advertising Warnings approved by Supreme Decree No.  012-2018-SA, within the framework of Law 
No. 30021 on the  promotion of healthy eating among children and adolescents and its Regulations 
approved by Supreme Decree No.  017-2017-SA. The Codex Alimentarius, in the General Standard G/TBT/M/89  
 
- 52 - 
 
  for the Labelling of Prepackaged Foods (CXS  1-1985), recognizes the application of s upplementary 
labels on condition that the information on the original label is fully and accurately reflected, 
complying with the requirements of the country of destination, allowing the same purpose of 
protecting public health and consumer information to be fulfilled. We therefore request Peru to 
establish adhesive labelling on a permanent basis, given that this achieves the same legitimate 
objective and constitutes a less trade -restrictive measure.  Regarding the points made to Peru at 
previous meetings on  Supreme Decree No.  015-2019-SA, they remain valid as Guatemala's position.  
2.215.   The representative of Chile provided the following statement. Chile once again states that 
the regulation established by the Supreme Decree amending the Manual of Advertising Warni ngs 
approved by Peru has been a source of concern to the enterprises and trade associations exporting 
packaged food to that destination, in that the acceptance of labelling with stickers on products from 
abroad is not permanent. Chile would be grateful if Peru would consider the permanent acceptance 
of this labelling for food in order to avoid the creation of an unnecessary technical barrier to trade 
in these products to Peru.  
2.216.   In response, the representative of Peru provided the following statement. Peru thanks the 
European Union, Costa Rica, Colombia, Brazil, Paraguay, Guatemala and Chile for their statements 
and comments.  As we have stated on previous occasions, Peru is committed to achieving its 
objectives of prot ecting the health of its citizens and most vulnerable groups, such as children and 
adolescents, in accordance with its international trade commitments in this domain. Peru is therefore 
seeking to ensure that the information contained in the Manual of Adver tising Warnings reaches 
consumers clearly and effectively to enable them to make informed choices.  In response to the 
concerns expressed by some Members, Peru has re -extended, through Supreme Decree No.  0022-
2022-SA, the period during which the use of adhe sive warning labels is allowed until 30 June 2023.  
In this respect, we would like to reiterate that we continue to coordinate internally so that we can 
have a definitive response on this issue.  We would also like to reiterate that Peru wishes to honour 
its WTO commitments and therefore reaffirms its commitment to not preparing, adopting or applying 
technical regulations that may create unnecessary barriers to trade.  
2.1.3.21   European Union - Non-renewal of the approval of the active substance 
mancozeb, G/TBT/N/EU/712 ; G/TBT/N/EU/797 , G/SPS/GEN/1494/Rev.1  (ID 62748) 
2.217.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concern raised with Paraguay, Brazil, Australia, Colombia a nd Kenya 
regarding the draft implementing regulation notified by the EU, under which approval for the use of 
mancozeb would not be renewed. We support the statements of the delegations that have joined 
the proponents of this concern.  
2.218.   The representative of Kenya  provided the following statement. Kenya echoes her previous 
statement on this Specific Trade Concern. Kenya raised this as a Specific Trade Concern in the 
previous TBT Committee meeting and continues to have concerns over the same issue. The active 
substance mancozeb is an important molecule in pest control in Kenya. Mancozeb containing 
products are used in the agriculture sector for the control of a wide range of fungal diseases found 
in the tropics. Its use is critical in the Flower Industry, which is a leading sector in terms of the 
Kenya's GDP and also employing thousands of Kenyans thus impacting livelihoods. Mancozeb has 
been an important molecule in relation to fungal pathogens control on a number of vegetable crops 
including Potato, Tomato, Oni ons among others. There are no available alternatives to offer multisite 
fungicide for control of early and late blight on the above crops; which cause annual yield losses of 
up to 60 -70% on the 4.5 -5.5 Million Metric Tonnes (USD 1.9 Billion) of potato, 56 0,000 Metric Tonnes 
(USD 333 Million) of Tomato respectively produced in Kenya for local consumption.  
2.219.   Mancozeb has a multi -site contact activity which is a key aspect for resistance Management. 
Kenya wishes to raise this STC since the Measure is deemed to be more trade restrictive than 
necessary contrary to Article 2.2 of the TBT Agreement. The proposed measure would be deemed 
to be in contravention of Article 12.3 of the TBT Agreement which requires that "Members shall, in 
the preparation and application o f technical regulations, standards and conformity assessment 
procedures, take account of the special development, financial and trade needs of developing 
country Members, with a view to ensuring that such technical regulations, standards and conformity 
assessment procedures do not create unnecessary obstacles to exports from developing country 
 
48 For previous statements follow the thread  under ID 627 . G/TBT/M/89  
 
- 53 - 
 
  Members ". Kenya requests the European Union to consider the withdrawal of the Regulation as the 
measure is more trade restrictive than necessary.  
2.220.   The representative o f 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 w hose use is 
approved for many different crops by the Brazilian Health Regulatory Agency, including soy. MRLs 
for soybeans in Brazil are set in 0,3 mg/kg. Around 11% of the soy produced in Brazil is exported to 
the EU. Therefore, restrictions on mancozeb wi ll significantly impact the income of Brazilian farmers. 
The availability of an alternative to mancozeb in the short to medium term is also limited by the fact 
that other substances of similar use have already been banned in the European market, such as 
chlorothalonil. Mancozeb is an important substance for the management of fungicide resistance to 
control soybean rust. It is used as a crop protection additive, intended to increase the effectiveness 
of other fungicides, minimizing resistance, and prolonging  the life cycle of other molecules. In light 
of the insufficient transitional period granted by the EU, such crops could not have their treatments 
changed in time for exportation to the EU market before the entry into force of the regulation. Brazil 
regret s that European authorities have not established transition periods that were 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, to c onsider less trade -restrictive 
alternatives that would also safeguard its legitimate policy objective and to grant a treatment for 
Brazilian farmers no less favourable than that granted to European farmers.  
2.221.   The representative of Colombia  provided the follo wing statement. Colombia once again 
places on the agenda this trade concern about the measure notified by the European Union relating 
to mancozeb.  As we have mentioned previously, the EU has adopted measures resulting in the non -
approval of the use of cert ain substances, adopting a hazard -based or precautionary approach, 
without any real risk identification.  Thus, measures for the suspension or non -approval of active 
substances and the subsequent reduction of their maximum residue levels (MRLs) to the lowest limit 
of detection are being adopted without any sound scientific evidence and without demonstrating that 
they are indeed the least trade -restrictive measures to achieve the desired level of protection.  This, 
of course, is creating an unnecessary te chnical barrier to trade, with the obvious implications for the 
agricultural and agro -industrial exports of Colombia and other trading partners.  
2.222.   The above is more serious for at least two reasons: first, there are currently no alternatives 
to mancozeb that  are duly registered and are equally effective; second, other similar substances  
such as chlorothalonil or dithiocarbamates have already been limited in the European market.  It is 
also a concern that the number of substances prohibited by the EU Commission  is increasing. This 
situation has serious implications for a number of WTO Members, particularly developing countries, 
whose populations and economies are heavily dependent on agricultural exports.  I would like to 
recall the importance of taking account o f international standards, guidelines and recommendations, 
and also of scientific information produced by the international standard -setting bodies recognized 
by the WTO, as well as providing reasonable transition periods.  The sole aim of all the above is to 
encourage movement in the direction of good regulatory practices, under which rules should be 
based on clear and objective information, and open dialogue with stakeholders, transparency, and 
reduction of market distortions should be promoted.  
2.223.   The repres entative of Paraguay  provided the following statement. There are some new 
developments that we would like to discuss, but have yet to receive answers to the questions we 
have submitted. This is the same statement that I delivered at the previous meeting, h oping for 
different results and full answers from the EU to the questions submitted in the SPS Committee and 
in this one. This concern and the non -renewal of the approval of other substances were already 
discussed extensively both in this Committee and in the SPS Committee because of the subsequent 
reduction in the MRLs. Paraguay therefore 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.  
2.224.   The arguments in favour of the use of this substance have not changed either, and these 
are shared by the EU, or at least by several of its members, who consider them sufficient to provide 
emergency authorizations, as follows:  - the lack of available alternatives to protect against some 
pests;  - the importance of mancozeb to avoid problems with resistance and, in general;  - the 
production and financial losses caused by some pests that only thi s substance can combat effectively.  
With regard to these emergency authorizations, we have already heard the EU say that the measures G/TBT/M/89  
 
- 54 - 
 
  are only in place for 120 days, but we recall that there is no limit to the number of times that they 
can be renewed.  
2.225.   We see, for example, how many of the emergency authorizations for mancozeb are given 
for approximately the same annual period (roughly June to September or October), probably linked 
to the threshold of humidity and warm temperatures that increase the prevalenc e of some of the 
fungi that are effectively and safely controlled by substances like mancozeb.  Imagine, how much 
more often these thresholds are reached in subtropical countries like Paraguay with climatic 
conditions very different from those of the Europe an Union.  We have also heard the EU explain that 
emergency authorizations are not intended to facilitate trade, unlike import tolerances, but we have 
not received answers to repeated written questions on the specific mechanisms used to grant 
emergency auth orizations and to ensure that products with temporary MRLs are kept within the 
borders of the authorizing member, and on the consistency between these authorizations and alleged 
concerns about the use of these substances. Here we note not only the discrimi nation that exists in 
practice between EU producers and trading partners but also an inconsistency between the legitimate 
objective pursued and the actions taken to achieve it. ¨ 
2.226.   Furthermore, we have heard that, although emergency authorizations are granted  by EU 
members, the EFSA reviews them if it considers that they are not properly justified. However, we 
note that even in cases where the EFSA considers that an emergency authorization is not properly 
justified, there are no restrictions on new emergency a uthorizations, which continue to be approved 
by the same members for the control of the same pests on the same crops for which the EFSA 
concluded that the use of the substance was not properly justified.  Paraguay shares the objectives 
that the EU seeks to meet 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 for hazard control, which do not exist in  this case, as 
the EU agrees by granting emergency authorizations to its members.  We reiterate our question on 
how the Members concerned by the process can participate in the analysis that the EFSA is 
conducting on the MRL for mancozeb; on the current stat us of the analysis, since an outcome was 
expected in the first half of 2022; and on how comments submitted by Members will be taken into 
account.  
2.227.   We are also seeking detailed responses to the queries regarding emergency authorizations 
that were raised in t he SPS Committee and were not satisfactorily answered with the statement that 
it "is the responsibility of the EU member States", who are also WTO Members in their own right and 
to whom we should address questions if we receive no responses.  Lastly, we can not fail to recognize 
the extraordinary efforts that the EU is making in the bilateral/plurilateral and multilateral spheres, 
including through dual notifications (TBT/SPS). However, what my country and my country's 
producers need is not a unilateral expla nation of the measures but a frank dialogue that allows the 
legitimate demands we are making to be met while at the same time achieving the EU's legitimate 
objectives in the least trade -restrictive way possible, in compliance with the rules and principles of 
the multilateral trading system.  
2.228.   The representative of Australia  provided the following statement. Australia remains 
concerned with the EU's non -renewal of Mancozeb. As there is limited availability for alternatives, 
this is having a significant impact on trade, including wine exports to the EU. We maintain the 
hazard -based approach adopted by the EU does not adequately assess risk of potential harm because 
it does not consider the level of exposure. Australia welcomes further information on the EFSA's 
scientific opinion on the concerns we have previously outlined. We also note our competent domestic 
authority – the Australian Pesticides and Veterinary Medicines Authority – and Codex have 
determined MRLs for dithiocarbamates that ensure the continued prot ection of human, animal and 
environmental health while allowing trade to continue.  
2.229.   The representative of Guatemala  provided the following statement. W e regret that we are 
obliged to speak again on this matter, due to the fact that the European Union has st ill not responded 
to the issues raised.  We remain concerned about the non -renewal of the approval of the active 
substance mancozeb, because there is no information providing scientific evidence of damage that 
could be caused to human health by the active s ubstance mancozeb. On previous occasions, the EU 
has mentioned that it has identified potentially negative effects on human health, without presenting 
scientific evidence to this discussion body. The EU has still not shared with the countries concerned 
the information on contamination of the products that have been assessed on the basis of available 
scientific evidence.  When we speak of certainty required by producers, mancozeb is an example of G/TBT/M/89  
 
- 55 - 
 
  this. Here the EU notified the Committee on Technical Barriers to Trade of the non -renewal of the 
active substance mancozeb in 2020, and this April it will be three years that the MRL has been under 
review, a situation which does not create certainty for the domestic production sector in third 
countries.  Mancozeb is e ssential for the production of a number of strategic agricultural crops that 
are exported to different EU markets, such as fruit (including bananas and plantains) and vegetables, 
and this would also affect other countries, in particular tropical countries.  In view of the above, we 
request the EU not to change current MRLs for mancozeb, so as not to affect third countries' 
production and exports. We regret the fact that producers from third countries do not have the same 
treatment/benefits as European produc ers have enjoyed to date, such as emergency authorizations.  
We reiterate the importance of having a concrete dialogue that could lead to solutions that are not 
more trade -restrictive than necessary.  
2.230.   The representative of Ecuador  provided the following stat ement. Ecuador thanks Costa Rica, 
Kenya, Brazil, Colombia, Paraguay and Australia for including this concern under the agenda item of 
this Committee and reiterates its concern regarding the non -renewal of mancozeb.  We have already 
referred on previous occa sions to the importance of this plant protection substance and its use for 
many strategic crops produced in Ecuador and the region, such as bananas, cocoa, and others.  Our 
country remains concerned that there are currently no approved alternatives to manco zeb that are 
duly registered and equally effective as mancozeb.  The case of this substance is of particular 
importance not only for bananas, but also for other lesser export crops. Recent research by 
international bodies, which has been presented to the ra pporteur states of the European Union, 
shows that mancozeb does not produce adverse effects in humans, experimental animals or wildlife 
at concentrations below those at which effects would be expected as a result of systemic toxicity.  
2.231.   In view of the above,  it should be noted that, due to the way in which this substance is 
applied in banana production, the use of mancozeb is one of the most effective and environmentally 
friendly methods of phytosanitary control of black sigatoka, considering that this diseas e is the most 
destructive and poses the greatest economic risk to banana and plantain crops, with the potential 
to cause yield losses of up to 50%.  Therefore, prohibiting the use of this fungicide – without effective 
alternatives – would mean leaving produ cers in countries such as Ecuador without immediate plant 
protection tools for implementing programmes for the management and control of black sigatoka. 
Accordingly, Ecuador calls on the European Union to consider alternative measures that are less 
restric tive to trade, to identify substitute substances that would enable existing trade to continue, 
to base its measures on conclusive studies, not only on the precautionary principle, and to establish 
adequate transition periods for the registration of alterna tive substances, in view of the current 
shortage of available pest -control tools.  
2.232.   The representative of Uruguay  provided the following statement. Uruguay wishes to thank 
the delegations of Paraguay, Brazil, Colombia, Costa Rica, Australia and Kenya for raising this specific 
trade concern today, and agrees with many of the points raised by the delegations that took the 
floor previously.  Mancozeb is an active substance that is authorized and widely used in many 
countries, such as Uruguay, where it is used safely to control diseases and pests in various products 
in the domestic fruit and vegetable sector, such as apples, pears and citrus fruits. Of particular note 
is its use to control apple scab and pear scab, which are the main diseases affecting apple and  pear 
production and are caused by fungi of the genus  Venturia spp . In that connection, we share the 
concerns and requests expressed by other delegations, particularly in view of the possibility that, as 
a result of the ongoing dithiocarbamate review proce ss, the European Union will significantly reduce 
the corresponding MRLs, even to the limit of detection, without having any conclusive scientific 
evidence that substantiates such a decision in line with the SPS Agreement of the WTO.  
2.233.   In this regard, we woul d appreciate an update on the status of the ongoing review process 
for these substances, including the predicted date for the presentation of the EFSA scientific opinion 
on dithiocarbamates, as well as the expected time frame for any notification to the SP S Committee 
regarding the relevant MRLs.  In this context, like other Members, Uruguay recalls the importance of 
taking due account of international standards, guidelines and recommendations, and scientific 
information produced within the framework of inter national standard -setting bodies recognized in 
the WTO, such as the Codex Alimentarius; the obligation to open consultation periods that may 
serve as effective instances of regulatory cooperation between Members; and the need to grant 
reasonable transition  periods if an amendment to the MRLs is finally decided.  
2.234.   The representative of Panama  provided the following statement. Panama supports this 
concern and thanks Costa Rica, Kenya, Brazil, Colombia, Paraguay and Australia for including this G/TBT/M/89  
 
- 56 - 
 
  STC on the agenda . We echo the statements we have heard on this topic.  Panama reiterates its 
concern regarding the non -renewal of mancozeb. As we have mentioned at each meeting of this 
Committee in recent years, the active substance mancozeb is of vital importance to my co untry's 
main agricultural items. On account of its particular mode of action, it is irreplaceable in the control 
of Black Sigatoka, a major pest in tropical crops.  There is currently no other active ingredient that 
can replace mancozeb; this leaves the ind ustry deprived of phytosanitary tools and thus seriously 
affects Panama's exports to the European Union.  In view of the above, Panama requests the EU to 
align the MRLs with the limits established under the Codex Alimentarius, or to consider less trade -
restrictive alternatives, and not to accord less favourable  treatment to our farmers than that 
accorded to European farmers through the use of emergency authorizations.  
2.235.   The representative of Chile provided the following statement. The delegation of Chile 
appre ciates the placing of this specific trade concern on the agenda. With regard to the EU's non -
renewal of the authorization of the active substance mancozeb, this delegation echoes the trade 
concern referred to by those who spoke before me in this Committee.  
2.236.   In response, the representative of the European Union  provided the following statement. We 
have provided detailed explanations on this issue in previous TBT Committees. The non -renewal was 
based on a scientific assessment conducted under the EU Plant Prot ection Products Regulation 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. The EU would like to inform 
Members that EFSA has started a review of the existing Maximum Residue Levels (MRLs) for 
dithiocarbamates (group of substances which Mancozeb is part of). Following the possibility for 
contributio n from interested parties, as described in document G/SPS/GEN/1494/Rev.1 , EFSA 
launched a consultation with EU member States which was finalized on 9 December 2022. EFSA is 
now addressing their comments and its scientific opinion is expect ed to be published in the first half 
of 2023.  
2.237.   For advice on alternatives to Mancozeb, the EU pesticides database is publicly available and 
contains information on all active substances, their approval status and their main purpose (e.g. 
fungicide, insectic ide or herbicide). Independently of the situation under the EU Plant Protection 
Products Regulation, use restrictions of Mancozeb have been introduced under the EU Chemicals 
legislation (REACH), following the classification of the substance as CMR (carcino genic, mutagenic 
or reproductive toxicant) 1A or 1B under that same Regulation.  
2.1.3.22   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 ; G/TBT/W/774  (ID 63049) 
2.238.   The representative of the United States  provided the following statement. We continue to 
have concerns with India's Quality Control Orders (QCOs), which we summarized in a working 
document, G/TBT/W/774 , circulated at the November 2022 W TO TBT Committee meeting. Since 
2020, India's Ministry of Chemicals and Fertilizers has notified 44 QCOs to the WTO TBT Committee, 
each identifying chemicals and petrochemicals for which India intends to mandate compliance to 
standards set by the Bureau of  Indian Standards. We continue to reiterate U.S. industry's concerns 
regarding the Polyethylene Material for Molding and Extrusion QCO 2020 (Polyethylene QCO), 
notified as G/TBT/N/IND/191 . Specifically, U.S. industry has raised concerns about the m easure's 
labeling requirement, which mandates markings that must include "designation codes " identifying 
an array of technical information, including melting point, density, processing method, and 
application. Can India explain the objective and intended a udience for these labels? We remain 
 
49 For previous statements follow the thread under ID 630 . G/TBT/M/89  
 
- 57 - 
 
  interested in understanding how India has considered industry input on alternative, cost -effective, 
and mutually beneficial ways to fulfill India's regulatory objectives. How has India considered these 
proposed alternati ve options?  
2.239.   We continue to report U.S. industry's concern that requiring the labelling and affixation of 
information in print, with alphanumerical code unique to India, will impose administrative burdens 
leading to inefficiencies, delays, and additional co sts for exporters. While we appreciate India's 
previous extensions of the Polyethylene QCO, we kindly request an additional extension of the 
implementation timeline by twelve months, from April 2023 to April 2024. Because the Polyethylene 
QCO's unique labe lling requirement is based on neither international standards nor globally accepted 
practices, and because India has not yet indicated it will revise the QCO in response to Members' 
concerns, additional time will be critical for industry to determine a pat h towards compliance.  
2.240.   The representative  of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to reiterate its concerns about the Orders issued by India's Ministry of Chemicals 
and Fertilizers on phthalic anhydride, n -butyl acrylate, and  terephthalic acid, which were notified by 
G/TBT/N/IND/116 , G/TBT/N/IND/123  and G/TBT/N/IND/124 . We understand that India's 
implementation of Quality Control Orders (QCOs) is to ensure the quality of products manufactured 
in India and  their safety for consumers. Under the QCO system, officials from the Bureau of Indian 
Standards (BIS) have to be assigned to perform on -site factory inspection and take samples. Our 
manufacturers have repeatedly expressed concerns about the BIS's limited manpower and 
resources, which caused scheduled on -site factory inspection to be delayed unexpectedly, thereby 
resulting in the uncertainty of trade operations and harm to the rights and interests of our 
businesses. We urge India to implement the QCOs syste m in a manner in compliance with Articles 
5.2.1 and 5.2.2 of TBT Agreement on expediting application procedures and informing the stage of 
the application procedure.  
2.241.   We have lifted quarantine requirements for all international arrivals since 13 October 202 2. 
Hence, we suggest that BIS, through prompt dispatch of inspectors, accelerate the processes of on -
site inspection in Chinese Taipei so that our manufacturers can finalize mandatory certification 
requirements as soon as possible. In doing so, we believe that Indian companies will also avail 
themselves of the competitiveness of their products in the international market through the swift 
access to needed raw materials and semi -finished products of good quality from Chinese Taipei. In 
addition, we would als o like to encourage India to positively consider alternative measures suggested 
by Members in G/TBT/W/774  to facilitate processing of applications for BIS certification.  
2.242.   The representative of Indonesia  provided the following statement. Indonesia shares the 
concerns expressed by the delegations of the United States of America, Chinese Taipei, European 
Union, and Canada regarding India's Notifications G/TBT/N/IND/220 , G/TBT/N/IND/221 , 
G/TBT/N/IND/223  and G/TBT/ N/IND/224  regarding the implementation of the (Quality Control) 
Order for Acid Oil, Coconut Fatty Acid, Lauric Acid, and Palm Fatty Acid. Indonesia would like to refer 
to its last statement at the TBT meeting in November  2022. Indonesia emphasizes that India could 
provide sufficient transition period to allow industry to comply with the Indian regulation, which 
would be at least 12 months from publication or until 23 October 2023. In addition, Indonesia would 
encourage In dia to accept conformity assessment results issued by foreign conformity assessment 
bodies (inspection bodies) under the MRA/MLA and accreditation framework. We believe this would 
expedite the audit and certification process while reducing the cost of cert ification.  
2.243.   The representative of the European Union  provided the following statement. The European 
Union would like to support the delegations of the United States, Chinese Taipei, Indonesia, and 
Canada. The EU continues to systematically take note of all Indian TBT notifications pertaining to 
Quality Control Orders (QCOs) for chemical and petrochemical substances. As already stated in this 
Committee, some QCO notifications do not have a determined date of entry into force. The EU 
reiterates its request to India to provide structured information regarding the planned time for the 
adoption of these measures, as well as to provide an updated list of chemicals and petrochemicals, 
which have already been implemented and of those that are yet to be implemented, t ogether with 
copies of relevant Quality Control Orders. The European Union recalls its request for clarification, 
explaining the reasons for establishing India -specific Quality Control Orders when these chemical 
and petrochemical products already comply wi th internationally recognised standards. In accordance 
with the TBT Agreement, standards are considered as voluntary, whereas mandatory standards are 
considered as technical regulations. Article 2.2 of the TBT Agreement, states that Members shall G/TBT/M/89  
 
- 58 - 
 
  ensure th at technical regulations are not prepared, adopted or applied with a view to or with the 
effect of creating unnecessary barriers to international trade. The EU would also like to encourage 
India to align the BIS standards with well -established and recognis ed international approaches.  
2.244.   The representative of Canada  provided the following statement. In previous Committee 
meetings, Canada raised concerns over the approach taken by India to make mandatory the use of 
Indian Standards on the regulation of a series of chemical substances. Canada remains of the view 
that the notification process followed by India to inform interested parties of its "Quality Control 
Orders" (QCO) is problematic, and that a number of systemic issues persist with respect to the QCO 
frame work. Last November, Canada joined the room document G/TBT/W/774  which serves to 
highlight these key concerns. We hope that India will respond to these concerns and will ensure that 
the implementation of the order is conducted in ways that are consistent wi th India's WTO TBT 
obligations.  
2.245.   The representative  of Singapore  provided the following statement. We thank the proponents 
for raising this STC, as well as India for the bilateral meeting yesterday. While we appreciate India 's 
clarifications, Singapore woul d like to echo the concerns raised by other Members and would like to 
reiterate our concerns expressed at the previous meetings of this Committee, as contained in 
document G/TBT/M/88 . Singapore remains concerned that India 's Quality Control Orders for 
chemica l and petrochemical substances could affect foreign chemical manufacturers ' access to the 
Indian market, given the onerous requirements for industry stakeholders to comply with the new 
measures, some of which are not aligned with international standards. We respectfully urge India to 
consider accepting relevant international stan dards, where possible, to avoid duplicative 
requirements, reduce the industry 's compliance costs, and ensure that the measures imposed are 
not more trade -restrictive than necessary to fulfil India 's regulatory objectives.  
2.246.   In response, the representative of  India provided the following statement. We would like to 
reiterate our comments on this issue. The Bureau of Indian Standards (BIS) is carrying out physical 
inspections for applications received from foreign manufacturers, where the country to be visited is 
facilitating the visit of fully vaccinated BIS officers who are carrying negative RT -PCR test report and 
without the requirement of any quarantine. With respect to applications received from Chinese 
Taipei, visits of the inspectors are being planned whe rever necessary formalities such as payment 
of application charge, scrutiny of application etc., have been completed.  
2.1.3.23   India – Draft Food Safety and Standards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180 , G/TBT/N/IND/237  (ID 66750) 
2.247.   The representative of the United States  provided the following statement. The United States 
remains concerned with India's measure, notified to the WTO TBT Committee as G/TBT/N/IND/180 ; 
and would also like to address G/TBT/N/IND/237 , which app ears to be a related measure for facility 
registration. During the November 2022 TBT Committee meeting, India noted that a registration 
measure had been published, and it appears that this measure was later notified as 
G/TBT/N/IND/237 . The United St ates provided comments on this proposed measure that has 
maintained an implementation date of 1 February 2023. We appreciate India's confirmation that 
trade will continue uninterrupted past this date, even for those countries who cannot provide lists of 
exporting manufacturers by that date. In our comments, the United States noted concerns with this 
measure; in particular, we noted the undue burden placed on foreign competent authorities to 
maintain lists of manufacturing facilities that produce certain pro ducts and export to India. We urge 
India to be flexible and take into account the approaches of different trading partners in providing 
lists of exporting manufacturers. We look forward to further technical discussions in this regard.  
2.248.   In addition, while th e measure notes certain affected product categories, a list of harmonized 
tariff codes of products subject to registration has not been provided, and, thus the scope of the 
measure remains unclear. Furthermore, the United States remains concerned with Indi a's draft 
measure, Food Safety and Standards (Import) Amendment Regulation, 2020 ( G/TBT/N/IND/180) . 
The measure states that India may identify categories of "risk" for food products "from time to time… 
for which inspection or audit of foreign food  manufacturing facilities producing such categories of 
foods shall be mandatory. " We are still concerned about the lack of information regarding the scope 
of this proposed burdensome technical regulation, and hope that India will provide any scientific and  
technical information that is used to determine the specific "risk" for food product categories; as well 
 
50 For previous statements follow the thread under ID 667 . G/TBT/M/89  
 
- 59 - 
 
  as information on audit processes. We look forward to receiving further information and clarification 
from India on these two concerning measures.  
2.249.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on the India's import requirements related to 
the registration foreign food manufacturing facilities. Ref erring to the FSSAI Order of 10 October 
2022, the EU would like to thank India for clarifying the measure (including the scope of 
products/food categories subject to the registration), and for postponing the entering into force of 
the new requirements to 1  February 2023. However, the EU would like to note that several facilities 
have not yet been registered in the new India's Registration of Foreign Manufacturers - ReFoM online 
system, and recall that it did not receive a formal written reply to the comment s sent to India in 
February 2021 to the notification G/TBT/N/IND/180 .  
2.250.   Given the possible disruption to trade associated to delays in listing registered facilities, even 
if the registration is not associated to new sanitary measures; given the absen ce of any specific 
criteria to define the risks associated to the listing or delisting of facilities, which may go beyond the 
India legislation; and, finally, given the fact that there are different authorities in India regulating 
imports of the same produ cts, the EU would like to ask India to: Clarify the modalities related to 
audits in the exporting countries, inspections of facilities, border checks and health certificates 
associated with the registration of foreign food manufacturing facilities, if and when these 
requirements will be made mandatory by any of the India authorities; Provide written guidance to 
the exporting countries and companies on how they should register the facilities and send the lists 
of facilities to India, and to maintain them upd ated; Consider avoiding that the competent authorities 
of the export countries sign more than one certificate with the same sanitary measures. Finally, the 
EU would like to repeat its request to India to notify these amendments and future measures related 
to the registration of food manufacturing facilities to the WTO SPS Committee, as well as to reiterate 
the availability of the EU to cooperate with the competent authorities of India to enhance mutual 
understanding and avoid unnecessary and unjustified dis ruptions to trade.  
2.251.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at previous TBT Committee Meetings since February 2021 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 food products 
destined for India which has been implemented as of 1 February 2023. 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 import ed into India and 
what circumstances would instigate an audit or an inspection of a foreign manufacturing facility.  
2.252.   Canada remains concerned and would like to seek clarity on India's measures for targeted 
commodities, audit rates, compliance actions and ap peals, and implementation plan. We are of the 
view that India's approach in these areas could create unnecessary obstacles to trade. Canada 
thanks FSSAI for its prompt registration of Canada's food manufacturing facilities and publication of 
the list of es tablishments. While some of Canada's questions have been answered, a number of 
questions remain regarding these requirements and we look forward to India's response to our 
comments submitted to India's enquiry point. In closing, 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.  
2.253.   The representative of Japan  provided the following statement. Japan echo the previous 
speakers and would like to express its concerns regarding India's Order related to requirement to 
register foreign food manufacturing facilities. According to the India's TBT notification, the final date 
for comments was set as the middle of January 2023, a nd proposed date of adoption and entry into 
force of the Order was advised as 1 February 2023, which was just two weeks after the closing date 
for comments. Our concern is that the Indian authority would not have sufficient time to consider 
any comments pu t forward before the implementation. Moreover, although Japan submitted lists of 
food manufacturing facilities in accordance with the Order dated 10 October 2022, India has not yet 
registered some of the facilities on the list. Japan requests that India: ( i) Suspend implementation 
of the Order and give the exporting Members sufficient time to adapt to the newly introduced 
requirements, meantime, allow imports of designated food products without registration of the 
facilities; (ii) Specify the HS codes for t he designated food categories subject to the Order: milk and 
milk products; meat and meat products including poultry, fish and their products; egg powder; infant G/TBT/M/89  
 
- 60 - 
 
  food; and nutraceuticals; (iii) Clarify the details on how to apply for the registration of fo reign food 
manufacturing facilities; and (iv) Respond to the unanswered questions from Japan within a 
reasonable time.  
2.254.   The representative of Australia  provided the following statement. Australia recognises the 
right of the Indian Government to take measure s necessary to protect public health. Australia thanks 
India for providing clarification that this regulation applies to five food categories. This is in line with 
previous advice from the Food Safety and Standards Authority of India (FSSAI) that the propo sed 
regulations would not apply to all food establishments. Australia would appreciate information on 
India's risk assessment which concluded that additional measures required the registration of food 
manufacturing facilities with FSSAI, particularly for t hose which have not previously required 
registration in order to export to India. Australia can further advise that its export and domestic food 
production systems are underpinned by a robust legislative framework, which provides confidence 
to trading part ners that exported products are safe, traceable and meet importing country 
requirements. Australia would appreciate the opportunity to streamline the process so as to reduce 
the level of administrative burden for food industries and competent authorities. We suggest India 
consider the food safety systems of its trading partners in applying the regulation. Australia is happy 
to work with India to support a more risk and outcomes -based approach to food safety.  
2.255.   The representative of New Zealand  provided the fo llowing statement. New Zealand would 
like to thank FSSAI for their flexibility on the implementation of this new requirement and the more 
simplified information required to register premises and associated product. We understand the 
registration requiremen t, along with the new certification requirements and the completion of a 
country questionnaire, is FSSAI's new approach to ensuring food safety requirements are met by 
exporting country manufacturers. While we support this approach to ensure both food safe ty and 
faster clearance at the Indian border, we believe that the registration requirements could be simpler, 
yet remain robust. Currently countries need to register/list manufacturers and the particular 
products that each manufacturer wishes to export to India. New Zealand would like to suggest that 
food safety practices at a manufacturer will be the same for all products produced, therefore India 
should only require manufacturer listing, for the commodity type they produce, without the 
requirement to spec ify each individual product type and associated HS codes. An acceptable 
questionnaire along with official health certification issued by competent authorities should be 
sufficient to address any individual product risks.  
2.256.   In response, the representative of India provided the following statement. Food Safety and 
Standards Authority of India is a statutory body for laying down science based standards for articles 
of food and to regulate their manufacture, storage, distribution, sale and import, to ensure 
availability of safe and wholesome food for human consumption and for matters connected 
therewith. In pursuance to the section 25 of the Food Safety and Standards Act, 2006, FSSAI 
regulates and ensures the safety of food being imported in the country. Further, section 22 of Food 
Safety and Standards Act, 2006 envisages that no person shall manufacture, distribute, sell or 
import any novel food, genetically modified articles of food, etc. and such other articles of food which 
the Central Government may notify in this behalf. Accordingly, to envisage robust food safety and 
monitoring system, FSSAI has notified Food Safety and Standards (Import) Amendment Regulations, 
2021 dated 3 November 2021 which provides the legal framework for registration and inspection of 
foreign food manufacturing facilities. Further, as per the regulations, the registration and inspection 
of such facilities will be based on risk of food categories as specified by the Food Authority from time 
to time.  
2.257.   This regulation is intended to ensure tr aceability, including access to operations, of an 
overseas facility manufacturing high risk foods in order to verify implementation of appropriate 
measures at the source facility that enhance food safety. The Draft regulations were also notified at 
WTO TBT  committee for inviting comments. The comments have been received from various member 
countries w.r.t procedures and the list of commodities for which manufactures need to give details 
for registration. To address all such issues, FSSAI vide order dated 10  October 2022 notified that 
the registration of foreign food manufacturing facilities falling under Milk and Milk Products, Meat 
and Meat Products including Poultry, Fish, and their products, Egg powder, Nutraceuticals, Foods for 
Infant Nutrition and manuf acturers desirous to export such article of food to India shall register with 
the Food Authority before exporting to India. For the registration purpose, to be done by FSSAI, the 
Competent Authorities of the exporting countries are requested to provide the  list of existing 
manufacturers and of those intended to export such food products to India. The practice of G/TBT/M/89  
 
- 61 - 
 
  Listing/Registration of Foreign Establishment is already prevailing in many countries and similar 
procedures are being in place.  
2.258.   India being a deve loping nation and one of the biggest food market in world, ensuring safety 
and quality of food is of utmost importance and under the mandate of Food Safety and Standards 
Act. This provision will ensure the safety and quality of foods being manufactured for  import into 
India and also help to reduce time taken for the inspection and clearance at ports. FSSAI notified 
the requirement for registration of High Risk commodities to facilitate trade. The registration or 
listing of Foreign Food Manufacturing Facilit ies (FFMF) is not trade prohibitory but to create a 
database of foreign food manufacturing facilities which are exporting food products of these 
categories into India. Further, it may be noted that as on date, the FFMF which are not registered 
or listed at  FSSAI portal are also able to export their food products to India without any trade 
hindrance. So FSSAI has initiated the process of listing of FFMFs with the positive intent to facilitate 
trade.  
2.1.3.24   European Union - Chemical strategy for sustainability (impl ementation of the 
European Green Deal) (ID 69051) 
2.259.   The representative of Kenya  provided the following statement. Kenya raised this as a Specific 
Trade Concern in the previous TBT Committee meeting and continues to have concerns over the 
same issue. Kenya is  greatly concerned by one of the proposals that have been cited as one of the 
key deliverables of the European Green Deal policy that was enacted in 2020. This is the EU Proposal 
on Corporate Sustainability Due Diligence. The European Commission on 14 July  2021 adopted a set 
of intermediate proposals that aim to cut greenhouse gas emissions by 55 % by 2030 as part of a 
broader European Green Deal (EGD). While the EGD is mainly an internal EU policy instrument, its 
potential for global spill -overs are likely  to have significant impacts on production and trade for 
developing countries. Kenya is therefore concerned that this measure has not been notified. 
Published on 23 February 2022, the EU proposal on Corporate Sustainability Due Diligence poses 
significant barriers to trade between Kenya and the EU owing to the scope of its provisions. The 
proposal requires that EU companies work with exporters in identifying and preventing/mitigating 
adverse impacts of their activities on human rights (child labour, exploit ation of workers etc.) and 
on the environment (pollution, biodiversity loss etc.).  
2.260.   The EU claims that the objective of the proposal is to foster sustainable and responsible 
corporate behaviour throughout the global value chains. Kenya's concern is premised  on the fact 
that developing countries are already struggling to meet international standards, technical 
regulations, and conformity assessment procedures necessary for international market access. 
Imposing additional sustainability requirements as prerequ isites for market access will be 
burdensome (in both financial costs and technical capacities) to value chain actors across the 
developing world, including Kenya. There is also a further concern that these private standards are 
often developed without the input from the developing countries, yet they are expected to comply/ 
implement them without any clear commitment for technical support. In light of the above the 
proposed measure would be deemed to be in contravention of Article 12.3 of the TBT Agreement 
which requires that "Members shall, in the preparation and application of technical regulations, 
standards and conformity assessment procedures, take account of the special development, financial 
and trade needs of developing country Members, with a view t o ensuring that such technical 
regulations, standards and conformity assessment procedures do not create unnecessary obstacles 
to exports from developing country Members ". While noting EUs response that this strategy was for 
purposes of outlining future po licy, Kenya reiterates the need for a comprehensive dialogue with the 
EU and other Members of the WTO on this matter; prior to advancing to further stages in the 
development of this policy.  
2.261.   The representative of the Russian Federation  provided the followin g statement. The Russian 
Federation would like to reiterate its concern on the European chemical strategy for sustainability. 
Despite the fact that the Strategy is a non -binding document, it is a strong political commitment 
which involves plans to tighten even further current regulation of chemical substances and mixtures 
under the CLP/Reach Regulations as well as other product specific regulations which will further 
restrict the use of certain materials, as it already happened with cobalt, lithium and nick el under the 
CLP and battery production regulations. In December 2022, the European Commission published the 
Recommendation for safe and sustainable chemicals, which contains classification of hazardous 
 
51 For previous statements f ollow the thread under ID 690 . G/TBT/M/89  
 
- 62 - 
 
  properties and their influence on human health and en vironment. However, the classification is based 
upon the REACH Regulation which lacks of laboratory and epidemiological data or the scientific 
justification.  
2.262.   Once again, Chair, we find it important to repeat the fact the EU keeps imposing unilateral 
trade restrictions under the umbrella of European green deal despite the rules of WTO. None of the 
questions that we have been raising on the site on the WTO since June 2021, on that strategy have 
been addressed. Chair, once again it is regrettable that the EU h ave chosen not to engage on this 
issue as it has been refusing to respond to present concern for several meetings in a row. This 
situation is of systemic concern. Transparency is the important pillar of this organization and 
provision of explanations on va rious measures and policies in this Committee is the part of the 
mechanism. Refusal to respond to the raised trade concerns is in stark contrast to the EU's rhetoric 
about the importance of transparency in this organization.  
2.263.   In response, the representative of the European Union  provided the following statement. We 
would like to thank Kenya for taking the floor. Unfortunately, we need to insist that the EU Chemical 
Strategy for Sustainability is not a technical regulation in th e meaning of the TBT Agreement. It is 
only a communication document from the European commission addressed to the EU member States 
and stakeholders outlining future policy for the purpose of transparency. Furthermore, the EU 
Proposal on Corporate Sustainab ility Due Diligence is also not a technical regulation in the meaning 
of the TBT Agreement. Therefore, we are not able to give substantive feedback on this specific trade 
concern. However, we invite Kenya to raise their concerns in the appropriate forum wi thin the WTO 
framework.  
2.1.3.25   Egypt – Halal Certification Measure, based on Egyptian Standard ES 4249/2014 
General Requirements for Halal Food According to Islamic Sharia, G/TBT/N/EGY/313 , 
G/TBT/N/EGY/313/Add.1 , G/TBT/N/EGY/313/Add.2  (ID 71852) 
2.264.   The representative of the United States  provided the following statement. The United States 
acknowledges that Egypt has delayed implementation of new halal requirements for dairy products 
multiple times, with the most recent de lay until 1 April 2023. However, the lack of clear implementing 
procedures has had a chilling effect on U.S. exports, which require a lengthy transit before reaching 
Egypt. The United States requests that Egypt formally suspend any new halal requirements u ntil the 
transparency and certifier issues have been resolved, providing the assurance that U.S. exporters 
need in order to resume shipping to Egypt. The United States understands that a draft decree or 
regulation for halal certification of dairy products is under consideration. Does Egypt have an update 
on when it will be notified to the WTO? The United States also understands that Egypt is considering 
approving other overseas certification bodies; approving more than one certifier would help keep 
certific ation costs low and certification services competitive. The United States is supportive of this 
trade facilitating effort. Does Egypt have a timeline for when it will approve additional certification 
bodies?  
2.265.   Finally, the United States has repeatedly reques ted additional information about how Egypt 
will implement these new halal requirements. One of the most pressing questions deals with the 
scope of products. Based on the draft of ES 4249 shared by Egypt's Inquiry Point in 2022, it appears 
that Egypt will r equire halal certification for food products containing milk fat only "where grease or 
animal fats were added to it. " However, the HS codes that Egypt listed in Addendum 3 (HS 0401 – 
0404) are more extensive and do not match the language in the revised dra ft of ES 4249. When 
Egypt provides a regulation or decree formalizing these new halal requirements, the United States 
requests a clearly laid out scope of products. The United States looks forward to Egypt's response 
to these questions, as well as our past  requests. We greatly value our trading relationship with Egypt 
and fully support continuing to work with Egypt to ensure that its consumers have access to 
affordable and nutritious halal food products.  
2.266.   The representative of the European Union  provided the  following statement. The European 
Union would like to express concerns with regard to the requirements on Halal certification as of 1 
October 2021 based on the Egyptian Halal standard 4249/2014. The EU industry is worried about 
the negative impact of this  measure on food and beverages imports to Egypt. The EU appreciates 
that the requirement for dairy products was then suspended first until 1 October 2022 and later until 
the end of March 2023. However, this is just a temporary solution. The EU submitted wr itten 
 
52 For previous statements follow the thread under ID 718 . G/TBT/M/89  
 
- 63 - 
 
  comments on 26 January 2022 and would welcome a reply by the Egyptian authorities. In this 
context we appreciate the Egypt's notification from August 2022, addendum to the notification 
G/TBT/N/EGY/313  (G/TBT/N/EGY/313/Add.3) , providing more HS codes of covered products, 
information on relevant procedures and on labelling requirements. Nevertheless, a number of 
important and practical information for economic operators is still missing, such as deadlines for 
issuance of certificates by IS EG Halal, details on audits, etc. Finally, EU comment regarding the 
monopolistic position of the IS EG Halal, does not seem to have been taken into account either. In 
this context 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 a ccordance 
with the international best practices. Re -certification by IS EG Halal of products from establishments 
already certified by other companies is an unnecessary duplication and would lead to longer time to 
market and higher costs for consumers.  
2.267.   The EU would like to ask Egypt to consider keeping the Halal certification and labelling 
voluntary for dairy products, in order to pursue the legitimate objective of ensuring reliable 
information without unduly hindering trade flows. Consumers should be able t o decide whether to 
buy Halal -certified food or not, based on clear labelling. The EU would appreciate if Egypt would 
consider further trade facilitating measures, such as requiring Halal certification for the product and 
not per container, as well as prop ortional costs of Halal certification that take into account the 
international practice and correspond to the service rendered. Finally, the EU would like to ask Egypt 
about the concrete steps envisaged to provide comprehensive information about the new me asures 
and clear written and publicly available guidance to stakeholders, including a detailed description of 
the certification procedure, its duration, costs, and required documents, as well as the process for 
registration of suppliers. 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.  
2.268.   The representative of India provided the following statement. By this notification Egypt 
requires that requires that import s of meat, poultry and their products, milk and dairy products be 
accompanied by a Halal certificate issued by the relevant certification bodies in the exporting 
countries as determined by General Organization for Veterinary services (GOVS). As per the 
notification the proposed new regime only specifies one Egyptian certification body that will have 
the authority to certify halal products for the Egyptian market. This is expected to significantly raise 
cost of certification and will inevitably increase the time involved in the process. This measure could 
result in a certification process that is overly burdensome, costly and more trade restrictive than 
necessary to achieve Egypt's stated objective. India request Egypt to share the alternative 
approaches that  were considered before finalising this measure. Secondly, India would like to 
request Egypt to share the requirements by which Indian certification bodies can become eligible to 
issue halal certificates.  
2.269.   The representative of Kenya  provided the following statement. Kenya echoes her previous 
statement on this Specific Trade Concern. Kenya raised this as a Specific Trade Concern in the 
previous TBT Committee meeting and continues to have concerns over the same issue. Kenya's 
concern on this regulation is tha t the Egyptian authorities insist that only their firms can carry out 
Halal certification. Kenya has a Halal Certification Body (Bodies) that Egypt can partner with to meet 
their halal objective. This measure is deemed to be more trade restrictive than nec essary when 
Egypt requires that it's only ISEG Halal Egypt that can certify exports from other countries. This is 
contrary to Article 2.2 of the TBT Agreement. It is also contrary to the principle of national treatment 
by restricting who can carry out Hala l certification. This is contrary to Articles 2.1 of the TBT 
Agreement. This measure will be too expensive for Kenya's exports to the Egyptian market hence 
making Kenyan products uncompetitive. Kenya therefore requests that Egypt should work with the 
Kenya n Halal certification bodies.  
2.270.   The representative of Canada  provided the following statement. Canada continues to be 
concerned by Egypt's new halal certification requirements for all imported food and beverage 
products. Canada understands Egypt's objective to ensure that Egyptian consumers are confident 
that they are buying and consuming Halal -certified products in agreement with Islamic Sharia. 
However, such measures should not create unnecessary barriers to international trade or be more 
trade-restrictive than necessary to fulfil that objective. While Canada welcomes Egypt's delayed 
implementation of the Halal certification for dairy products to March 31st, this is only temporary and 
Canadian exporters need more information and time to adapt to these new me asures This includes 
information on procedures, fee structures, details on audits (if needed), and specificity on how these G/TBT/M/89  
 
- 64 - 
 
  requirements will be implemented. Additionally, Canada is seeking confirmation that the list of HS 
codes and associated products sha red in August 2022 is the finalized list.  
2.271.   Canada encourages Egypt to reconsider this measure considering the degree of uncertainty, 
lack of clear implementation protocol, and unnecessary added cost and administrative burden. For 
example, the proposed new r egime only specifies one Egyptian certification body that will have the 
authority to certify halal products for the Egyptian market. It is our understanding that this has 
already significantly raised the halal certification fee which will have to be borne by exporters of 
halal product to Egypt. The new measure could result in a certification process that is overly 
burdensome, costly and more trade restrictive than necessary to achieve Egypt's stated objective. 
Canada strongly encourages Egypt to have open a nd 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 before the measure is enforced. Egypt could also consider opening a 
halal certificat ion office in Canada to facilitate trade, as is the case with other members. Canada is 
open to discussing this further bilaterally. Until then, we respectfully request that Egypt suspend the 
implementation of the measure.  
2.272.   The representative of New Zealand  provided the following statement. New Zealand thanks 
Egypt for the further extension of the requirement for dairy products to meet Egypt Halal 
requirements. We note that the final halal standard is still not available and suggest Egypt consider 
a reasonabl e implementation period once this is notified to the WTO as a final standard. We 
understand there may be further requirements to meet Egypt's new Halal standard and request 
these are also appropriately notified to the WTO, with sufficient time to enable me mbers to provide 
feedback and implement requirements.  
2.273.   The representative of Switzerland  provided the following statement. Switzerland continues 
to follow this matter with interest. We support the concerns raised by other Members with regard to 
the requirem ents on halal certification based on the Egyptian Halal standard 4249/2014 and refer 
to previous statements in this Committee on this matter. In particular, we reiterate our call on Egypt 
to provide flexibility for the continued recognition of foreign Hala l certification bodies and to clarify 
the details and criteria for the acceptance of foreign Halal certificates.  
2.274.   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 food and beverage products of animal origin. Australia also takes this opportunity 
to again thank Egypt for notification of the third addendum to G/TBT/N/EGY/313  on 15 August 2022. 
Austr alia notes that this addendum, while providing clarity on the procedures exporting 
slaughterhouses and factories must undertake to export to Egypt, it does not provide any information 
on facility audits set to be undertaken by IS EG Halal. Australia respec tfully requests that information 
of this nature be provided as part of a draft technical measure for notification to the WTO, ideally in 
the primary document and not as an addendum. Notification of draft technical measures to the WTO 
will allow Members the  opportunity to provide comment before implementation to ensure that 
requirements, when finalised, meet both Egypt's policy goals while ensuring measures are not more 
trade restrictive than necessary. Australia notes that it provided written comments to 
G/TBT/N/EGY/313  in January 2022 and would welcome a response from Egypt. Australia also invites 
Egypt to separately notify the TBT Committee of the revised Egyptian standard 4249 "General 
Requirements on Halal Food according to Islamic Sharia" as adv ised in addendum three before 
finalisation and publication. Australia welcomes ongoing discussion on the implementation of Egypt's 
new Halal certification measures.  
2.275.   The representative of Paraguay  provided the following statement. We thank the delegations 
of the United States of America, the European Union, India, Kenya and Canada for including this 
item on the Committee's agenda and we request that the support of Paraguay be recorded.  While 
Paraguay shares Egypt's interest in providing its consumers with ce rtainty regarding the purchase 
and consumption of halal -certified products, the lack of clear information and details on application 
procedures prevents operators from being able to adapt to comply with them.  Paraguay again 
requests Egypt to suspend the im plementation of new halal certification requirements until Members 
have all the requested information and business operators have sufficient time to adapt in order to 
comply.  
2.276.   In response, the representative of Egypt  provided the following statement. Egypt thanks the 
United States, the European Union India, Kenya, Canada, New Zealand, Switzerland, Australia and G/TBT/M/89  
 
- 65 - 
 
  Paraguay for their interest in this issue and their continued engagement on the matter, while 
recognizing Egypt's right to adopt the halal certificat ion requirements, which we deem necessary 
and appropriate to achieve our legitimate policy objective yet remain consistent with our obligations 
under the TBT agreement.  Recognizing the comments that our trading partners raised in the last 
committee meeting  and in the bilateral meetings we had with them, Egypt would like to point out 
that Since the introduction of the requirement with respect to milk and dairy products by General 
Organization For Veterinary Services  (GOVS), Egypt has introduced a number of f acilitating 
measures extending the time line to abide by the requirement for over a year now. This has provided 
the business operators an appropriate period of time to adapt to the set of requirements.  It is also 
important to note that since its initial no tification, Egypt has been clear that the certification body 
currently recognized by the General Organization for veterinary Services is ISEG Halal. In fact, a lot 
of exporters have indeed approached ISEG Halal and issued the Halal certification successful ly. 
2.277.   The TBT Agreement gave explicit regulation to all WTO Members to protect legitimate 
interest according to own regulatory autonomy . It is also important to clarify that the Egyptian 
standard ES4249 does not and shall not provide for any supervision requ irements for a specific 
certification body."  As indicated in G/TBT/N/EGY/313/Ad d.3 the scope of products requiring halal 
certification was clear and confined to the products specified in this addendum except for crude milk, 
it should be further noted that no imports of milk and dairy products not a ccompanied by Halal 
certificate have been denied entry in Egypt, since this regulation entered into force and will continue 
enjoy this exception till 31 March 2023.  I would also like to remind the Committee that Egypt has 
taken measures to ease the applica tion of this decision giving particular attention to the 
considerations and interests of our trading partners.  I would also like to note that ES 4249 for 2014 
is currently under review and any changes or amendments will be duly notified to the WTO TBT 
Comm ittee. 
2.278.   It is worth noting, that we received specific questions from some members, and we have 
provided answers and replies to many of those questions, and our colleagues in Cairo are working 
on the remaining questions, we will be sharing those answers in d ue course in accordance with the 
terms and procedures of this committee.  Finally, I would like to stress that Egypt is committed to 
continue its bilateral exchanges on the matter with all interested trading partners and to take into 
account their concerns as appropriate and stress our commitment to the transparency requirements 
under the TBT Agreement.  We urge our trade partners to provide information on the amount of 
bilateral trade affected by this measure. Or at least to indicate if consignments shipped have faced 
or are currently facing access barriers at Egypt 's entry points that are connected to this measure, 
this will help us assess the magnitude and nature of matters/concerns that we need to deal with to 
secure the interest of our trade partners whil e mainstreaming our policy objective for which this 
measure was adopted.  
2.1.3.26   Indonesia - Government Regulation 28 of 2021 – Implementing Regulation (for 
the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act", 
G/TBT/N/IDN/152  (ID 72453) 
2.279.   The representative of the United States  provided the following statement. The United States 
continues to have serious concerns with the Government of Indonesia Regulation No. 28 of 2021, 
which is the Implementing Regulation (for the Manufacturing/ Industry Sector) to Law No. 11 of 2020 
of the "Job Creation Act " (GR28/2021). We understand the recently notified G/TBT/N/IDN/152 , 
Ministry of Industry No. 45 Year 2022 regarding Standardization of Industry (MOI 45/2022), may 
be part of the impleme nting regulations for GR28/2021. Is MOI 45/2022 intended to fully implement 
GR28/2021, or does Indonesia anticipate publishing additional implementing regulations for 
GR28/2021? We are disappointed that Indonesia appears to have notified MOI 45/2022 in Jan uary 
of 2023, despite the measure being signed and having entered into force in November of 2022. We 
urge Indonesia to meet its obligation under the WTO TBT Agreement to notify regulations to the 
WTO TBT Committee in draft form prior to finalization. We ha ve recently submitted comments on 
this measure, and we look forward to Indonesia's response.  
2.280.   We refer Indonesia to our previous statements from November 2021, and March, July, and 
November 2022. Many of our concerns remain unanswered. Without reiterating t hem, we ask 
Indonesia to respond, and we again strongly request Indonesia to ensure that all domestic 
conformity assessment bodies are continuing certification of foreign products. In particular, we 
 
53 For previous statements follow the thread under ID 724 . G/TBT/M/89  
 
- 66 - 
 
  remain interested in the justification for requiring conf ormity assessment testing be conducted by 
Indonesian citizens residing in Indonesia? How do these requirements relate to the ability to perform 
conformity assessment?  
2.281.   The representative of the European Union  provided the following statement. The European 
Union is seriously concerned by Government Regulation No.28 of 2021 and new requirements for 
Indonesian National Standard (SNI) certification. This Regulation is one of the implementing 
regulations of the Omnibus Law on Job Creation (Law 11/2020) recently a dopted. 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). The new requirements affect in principle all products subject 
to SNI certification and it is very complex to export to Indonesia. In addition, due to lack of 
guidelines, the situation has not progressed and certain sectors appear to be particularly concerned 
(e.g. toys, tyres and machinery). The European Union refers for the record to its previous statements 
and notes that the majority of the issues remain unanswered.  
2.282.   The European Union invites Indonesia to respond to our concerns and in particular to make 
sure that the conformity assessment bodies are continuing certification of foreign products. We 
remain available to discuss the issue also bilaterally.  
2.283.   The representative of Canada  provided the following statement. Once again, Canada 
reiterates the following p oints from previous meetings of the Committee, specifically outlined in our 
statement at the July 2022 TBT Committee in paragraphs 2.402 -2.404 of G/TBT/M/87 , and which 
we are referring to today for the record: Canadian industry stakeholders have reported that  the 
various requirements of this measure remain the same and therefore continue to represent an 
unnecessary barrier to trade. At the November TBT Committee, Indonesia committed to answer 
Members' concerns through a formal written letter sent to our respec tive Enquiry Points. Canada is 
disappointed that it has yet to receive a response and would appreciate if Indonesia could provide a 
timeline on when Canada can expect one. Canada kindly asks that Indonesia provide the Committee 
with a response that specifi cally addresses Members' concerns.  
2.284.   Canada also takes this opportunity to express strong concerns with Indonesia's Regulation 
45 of year 2022 regarding Standardisation of Industry, notified under G/TBT/N/IDN/152 , which we 
understand is linked to Government Regulation No. 28. This measure was notified to the WTO TBT 
Committee on 5 January 2023; however, the regulation was adopted and entered into force on 
1 November 2022. Even though Indonesia provided Members with a 60 -day comment period, can 
Indonesia explain how these comments will be taken into account, as per TBT Articles 2.9.4 and 
5.6.4, in the development of a measure that has already entered into force? In addition, can 
Indonesia provide a rationale as to why it did not provide for a reasona ble interval, recognized to be 
six months, between the publication of the measure and its entry into force, as per Articles 2.12 and 
5.9 of the TBT Agreement? Canada urges Indonesia to re -notify Regulation No. 45, provide Members 
with a meaningful 60 -day c omment period, and allow an interval of at least six months between the 
publication of the measure and its entry into force.  
2.285.   In response, the representative of Indonesia  provided the following statement. Indonesia 
thanks the United States, the European Uni on and Canada for their continued interest in Government 
Regulation 28 Year 2021. Indonesia would like to reiterate that Government Regulation 28 of 2021 
aims to clarify and complement the previous requirements set out in Government Regulation (PP) 2 
of 20 17 regarding the Development of Industrial Facilities and Infrastructure. Regarding the 
provisions for conformity assessment bodies that conduct SNI certification as regulated in this 
regulation, Indonesia is of the view that such provisions are general re quirements. The certification 
process for technical regulations based on SNI in the industrial sector is carried out in accordance 
with the provisions contained in the related Ministerial Regulation. All provisions regarding the 
standard and the conformity  assessment scheme apply equally for both domestic and foreign 
manufacturers. Regarding the implementing regulation number 28 of 2021, Indonesia has notified 
the Minister of Industry Regulation number 45 of 2022 concerning Industrial Standardization throug h 
document G/TBT/N/IDN/152  
2.286.   Regulation of the Minister of Industry Number 45 of 2022 contains procedures including how 
the Minister of Industry will evaluate the Conformity Assessment Body as mandated by Government 
Regulation Number 28 of 2021, in wh ich the regulation states that: The conformity assessment 
procedure is carried out by a Conformity Assessment Body accredited by the National Accreditation G/TBT/M/89  
 
- 67 - 
 
  Body of Indonesia (KAN) and appointed by the Minister of Industry; Based on the Regulation of the 
Minister of Industry Number 45 of 2022, it is further explained that the implementation of the 
conformity assessment procedure shall continue to be carried out in accordance with the previous 
regulations, until such regulations are amended; Indonesia accepts  test results from accredited 
foreign testing laboratories under the framework of mutual recognition agreements and the 
availability of technical regulatory agreements between Indonesia and its partner countries.  
2.1.3.27   European Union - Draft Commission Regulation amending Annexes II and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for clothianidin and thiamethoxam in or on certain products, 
G/TBT/N/EU/908  (ID 76354) 
2.287.   The representat ive of the United States  provided the following statement. The United States 
thanks the EU for its response to our comments on the "Draft Commission Regulation as regards 
maximum residue levels for clothianidin and thiamethoxam, " received on 26 January 202 3. The 
United States reiterates our shared concern regarding pollinator health, and notes our ongoing 
efforts to protect bees and other pollinators in the United States. To date, the global scientific and 
regulatory community has found that complex interac tions among multiple factors affect pollinator 
health, including the health of bees. Given the critical importance of the pesticides identified in the 
Regulation as part of integrated pest management programs on crops that are exported to the EU 
by many co untries, we are concerned that the proposed measure may pose a significant obstacle to 
international trade and production of agricultural products. The United States appreciates that in the 
EU's response to US comments, it recognized that global environmen tal challenges require 
collaboration across the global community and that these challenges cannot be addressed by one 
country or one region, as such actions may complicate or further delay meaningful progress on these 
pressing issues while unnecessarily af fecting agricultural production and trade.  
2.288.   The United States therefore encourages the EU to pursue a collaborative approach to 
protecting pollinators, using appropriate international venues to advance a shared understanding of 
this global challenge. The Un ited States notes that the Codex Committee on Pesticide Residue (CCPR) 
is not the appropriate venue to discuss environmental standards. The United States would like to 
remind the EU that environmental issues are not included in CCPR because MRLs are not in tended 
to be an environmental safety management tools. Rather, pesticide MRLs are intended to manage 
the food safety risk of treated imported food products upon arrival into a market. Using MRLs for 
alternative purposes may have unintended consequences tha t could undermine the development 
and use of international standards for food safety. The United States recalls its concerns regarding 
the 2018 EFSA risk assessments for this measure and notes the importance of completing science -
based risk assessments in their entirety prior to setting new MRLs. We request that the EU provide 
the scientific or technical information that demonstrates how the reduction of these MRLs to the LOD 
contributes to the objective of the protection of pollinators, including bees. In the absence of 
scientific or technical information indicating how the reduction of MRLs to the LOD on the impacted 
products contributes to the objective of protection of pollinators, including bees, the United States 
again requests that the EU maintain its  current MRLs for clothianidin and thiamethoxam. In place of 
the EU's proposed regulation, the United States would encourage the EU to take a collaborative 
approach to protecting pollinators and to provide the opportunity for WTO Members to contribute 
resources, scientific expertise, and new ideas.  
2.289.   The representative of Indonesia  provided the following statement. Indonesia thanks the EU 
for its notification of "Draft Commission Regulation as regards maximum residue levels for 
clothianidin and thiamethoxam " to the WTO as G/TBT/N/EU/908  which amends Regulation (EC) No. 
396/2005. Indonesia has received a response from the EU on 27 January 2023 to Indonesia's 
comments on 22 September 2022. However, Indonesia would like to reiterate and further explain 
the following points. Maximum Residue Levels (MRL) are related to food safety standard and not to 
environmental protection provision. The Imposition of MRLs for environmental protection deviates 
from the purpose of MRLs themselves. This raises a question of leg al basis where it shows 
inconsistency with the objectives of the EU MRL Regulation, which are twofold: (1) to ensure high 
level of consumer and animal health protection; and (2) to remove trade barriers and facilitate 
international trade. Regulation (EC) N o 396/2005 is a consumer protection directed regulation. It 
defines MRLs as "means the upper legal level of a concentration for a pesticide residue in or on food 
or feed set in accordance with this Regulation, based on good agricultural practice and the lo west 
 
54 For previ ous statements follow the thread under ID 763 . G/TBT/M/89  
 
- 68 - 
 
  consumer exposure necessary to protect vulnerable consumers; " and an import tolerance as "an 
MRL set for imported products to meet the needs of international trade ". Thus, MRLs and import 
tolerances have a dual role of protecting the consumer and to e nable trade.  
2.290.   Environmental considerations are not within the scope of Regulation (EC) No 396/2005 as 
these aspects are thoroughly covered by Regulation (EC) No 1107/2009 for pesticides that have 
been assessed and registered for safe use in the European Uni on. Hence, environmental impact data 
is not typically required to be submitted in the MRL application dossier. A similar regulatory approach 
generally applies in non -EU countries: environmental data are not part of the procedure for import 
tolerance settin g, but robust environmental risk assessment standards are in place for the 
registration and use of pesticides in the majority of jurisdictions, including the assessment of 
pollinator risk. Regulation (EC) No 396/2005 does not appear to provide a basis for considering 
measures that would regulate and affect the use of registered pesticides outside of the territory and 
jurisdiction of the Union. Thereby, it appears to conflict with the responsibility and authority of other 
sovereign nations, resulting in the extraterritorial application of European Union legislation, which 
may well be incompatible with the treaties, international agreements and commitments to which the 
Union and its Member States are party to, in particular within the framework of the World Tr ade 
Organization (WTO).  
2.291.   Referring to the EU's information that the draft Regulation does not require non -EU countries 
to ban the use of clothianidin and thiamethoxam on their own territory. In this regard, we would like 
to emphasize that non -EU countries h ave their own regulatory frameworks for assessing the risk of 
pesticides and their use, including on the environment and the risk to pollinators. Despite the draft 
Regulation does not oblige the non -EU countries to ban the use of clothianidin and thiametho xam in 
their own territory, the lowering of the MRLs to the Limit of Quantification (LoQ) is an indirect 
measure to avoid the use of clothianidin and thiamethoxam by those countries that have different 
agricultural practices to control pests, resulting in different but safe residue levels. As stated, the 
non-EU countries have their own regulatory framework that recognizes the safety of these products 
in use. In reference to global decline of pollinator, to our knowledge, pollinator decline is 
multifactorial  and cannot be associated exclusively to pesticide use, and particularly not a single 
pesticide class. When we talk about pesticides, we need to talk about proper product use, i.e., 
following label recommendations and best management practices, including m itigation measures 
where appropriate. Data from the Intergovernmental Science -Policy Platform on Biodiversity and 
Ecosystem Services (IPBES)55, which is often cited as a key global reference, confirms that no single 
factor alone can explain the pattern of bee colony losses observed in some countries, while bee 
colonies are increasing in others. The authors of the IPBES report have even been challenged by 
NGOs who point out that there is no conclusive link between the use of certain pesticides and the 
declin e of wild bees.  
2.292.   Positive trends are also reported by the UN Food and Agriculture Organization (FAO), which 
shows a significant increase in honey bee colonies in major agricultural countries from 2012 to 2019, 
including those where the two compounds in ques tion are registered and used.56 To resume, any 
new levels of MRL applied will put trade at risk, when even small exceedances that are perfectly safe 
for people, could lead to consignments being refused entry to the EU/returned or destroyed. The 
uncertainty  makes it less attractive for exporters from Indonesia as the risk of rejection is much 
higher. We hope that the EU will take this into account and refer the MRLs to international standards, 
such as CODEX as a reference for clothianidin and thiamethoxam in  or on certain products.  
2.293.   The representative of India provided the following statement. We remain concerned with the 
draft Commission Regulation amending Annexes II and V to Regulation (EC) No 396/2005 of the 
European Parliament and of the Council as regard s maximum residue levels for clothianidin and 
thiamethoxam in or on certain products. This concern was raised by India in the November TBT 
committee meeting. We thank EU for responding to India's concerns shared during the comment 
period. However, the issu e This issue still remain unresolved. This new notification is based on the 
assumption that use of these neonicotinoids (clothianidin and thiamethoxam) even at the level 
determined by Codex are harmful for bees. However, the impact of field -level neonicoti noid exposure 
on honeybee health and survival has been less decisive than assumed by the proposed EU 
notification. Based on this understanding, India seeks EU's explanation how it still considers 
regulating these neonicotinoids relevant. In addition to the  above, India also requests EU to share - 
 
55 IPBES 2016, https://ipbes.net/assessment -reports/pollinators . 
56 https://www.fao.org/faostat/en/#data/QCL . G/TBT/M/89  
 
- 69 - 
 
  the risk assessment demonstrating the need to fix the MRL of these two pesticides at the level of 
determination; and, its assessment vis -à-vis other approaches considered in arriving at the 
conclusion that this is the least trade restrictive approach possible. India also requests the EU to 
provide a detailed justification concerning the link between the new MRL limit set for clothianidin 
and thiamethoxam, and its correlation with objective sought to be achieved by t he EU under the 
WTO covered agreements  
2.294.   The representative of Canada  provided the following statement. Canada, like other Members, 
is disappointed with the EU's decision to adopt regulation EC No 396/2005 to lower the MRLs for 
clothianidin and thiamethoxam to the Limit of Quantification (LOQ) based on environmental concerns 
for the global pollinator population. This policy is more trade restrictive than necessary to reach its 
objective. It does not appear to recognize global research and good agricultural pr actice, and is 
outside the scope of the regulatory objective to protect vulnerable consumers. If a pesticide does 
not have dietary concerns and poses no risks to EU consumers, the EU should maintain the MRLs or 
harmonize with Codex. Canada has a robust reg ulatory system and is confident in the mechanisms 
we have in place to protect consumers and the environment. Canada protects human health and the 
environment by conducting rigorous scientific evaluations of the risks associated with pest control 
products, which is critical to enabling access to the pest management tools necessary to address 
pest pressures specific to the Canadian climate. By reducing neonicotinoid MRLs to default values 
when no dietary risks of concern have been identified, Canada is of the  opinion that the European 
Union is unjustifiably applying their domestic legislation extraterritorially and hope this will not 
become a pattern that continues.  
2.295.   The representative of Colombia  provided the following statement. First, we would like to 
expres s gratitude for the response that the European Union gave to Colombia at the end of January 
concerning our comments on what was a draft Regulation at the time.  Without prejudice to the 
foregoing, Colombia is bound to reiterate its concern about Regulation 2023/334 of 2 February 2023 
of the European Commission, which amends Annexes II and V to Regulation (EC) No 396/2005 of 
the European Parliament and of the Council, affecting the maximum residue levels (MRLs) for 
clothianidin and thiamethoxam.  In the previo us Committee, Colombia expressed concern about the 
draft Regulation, but since February this has been a reality and the issuance of the Regulation is a 
fait accompli despite the comments submitted by various trading partners.  
2.296.   While recognizing the right of  WTO Members to protect animal, plant and human health and 
the environment, Members are also bound by their WTO commitments, in particular as regards 
conducting science -based risk assessments and ensuring that measures are not more trade - 
restrictive than necessary.  However, the reduction of MRLs for the above -mentioned substances 
extends the scope of existing regulations beyond consumer protection to environmental 
considerations, which is precisely what we must avoid – namely, creating an unnecessary and 
unjustified barrier to trade.  It is clear that the proposed reduction measure will have an adverse 
effect on agricultural and agri -food exports to the EU and will negatively affect the livelihood of rural 
producers who earn their living from agricultural pr oduction.  In addition, and regardless of the 
degree of legitimacy of the objective pursued, the EU measure will result in a ban on market access 
for a wide range of products. We therefore find that there would be no proportionality between the 
objective pursued by t he EU and the disruptive effect on trade that the reduction of MRLs would 
have on the set of products covered by the measure.  In this regard, the Regulation would be contrary 
to obligations related to ensuring that measures are applied where necessary, min imizing negative 
trade effects and avoiding unnecessary restrictions to trade.  
2.297.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
concern about the EU's claim to use the MRLs for clothianidin and thiamethoxam, not to p rotect 
European  consumers, but as a means to regulate the use of neonicotinoids in production processes 
and methods in third countries. In Paraguay's view, the TBT Agreement was not designed to 
accommodate measures with clearly extraterritorial objectives.  Paraguay also has serious concerns 
regarding the compatibility of the notified EU measure with obligations relating to market access 
and non -discrimination under WTO rules.  Paraguay shares a genuine interest in environmental and 
biodiversity conservation,  and accords primacy to the protection of human, animal and plant health, 
including protection of pollinators, which also play a key role in global food production and contribute 
to higher yields of agronomically important crops.  But each country has parti cular needs and 
challenges in its agricultural production, on the basis of its geography, ecosystem and local scientific 
capacities, as part of the quest to attain and maintain sustainability in agriculture. This situation is 
reflected in the evidence -based regulatory frameworks applied to registration processes to assess G/TBT/M/89  
 
- 70 - 
 
  the risks of pesticides and their uses, including the assessment of risk to the environment and 
pollinators.  
2.298.   My country, like several other Members, submitted comments  on notification 
G/TBT/N/EU/908  within the established deadline but on 27  September  2022, only 23 days after the 
end of the comment period, the EU Standing Committee on Plants, Animals, Food and Feed 
(ScoPAFF) approved the proposal to reduce the MRLs for these substances  without modifications, 
which again leads us to think that notifications and comment periods are merely formalities and not 
intended to be taken into account.  This is compounded by the fact that written responses to 
comments that were taken into account in theory were only submitted several months later, on 
26 January  2023, only one week prior to the approval of Commission Regulation (EU) 2023/334 
(3 February  2023).  Allow me to add that this Regulation mentions my country among the various 
non-EU countries t hat have also restricted the use of these products with the aim of protecting 
pollinators, including bees. This is incorrect. The resolution mentioned in footnote 19 DOES NOT 
EXIST IN MY COUNTRY and the name of the Ministry mentioned does not correspond to  that of the 
Ministry responsible for the matter.  
2.299.   With regard to the questions already submitted at the previous meeting of this Committee, 
I would add a request for clarification of this incorrect mention of my country.  We also reiterate the 
following que stions:  How does the EU intend to address the special needs of developing and LDC 
Members in the area of finance, trade and development in accordance with Article 12.3 of the TBT 
Agreement?  In field 7 of notification G/TBT/N/EU/908 , the EU states tha t an objective of the measure 
is "to ensure that also commodities imported into the European Union do not contain residues 
resulting from good agricultural practices based on outdoor uses of clothianidin and/or 
thiamethoxam".  Could the EU clarify how it wi ll identify products with MRLs above the LOQ due to 
indoor use or other methods that do not affect pollinators?  Imposing restrictions on international 
trade will, in effect, make farmers in Paraguay and the region less competitive than farmers in 
Europe wh o do not have to contend with the same pests and climatic conditions to produce food, 
and who can also benefit from emergency authorizations to continue using these substances. ^This 
can be seen from the emergency authorizations granted for these substances  since the ban and the 
end of the grace period for their use in the EU.  
2.300.   How are these emergency authorizations compatible with the non -discrimination obligation?  
What is the average approval time for an emergency authorization?  What is the average cost of the 
emergency authorization approval process?  These questions were repeatedly raised in other 
committees, but the EU response was limited to noting that emergency authorizations are issued by 
EU member States, and each member State determines the length of  the evaluation process and 
the costs.  We reiterate these questions, however, and hope to receive answers to them, especially 
since EU  members are also Members of the WTO in their own right and it may be necessary to start 
asking each of them questions sep arately.  The EU insists that, although emergency authorizations 
are the responsibility of the members, the European Food Safety Authority (EFSA) reviews them and 
rules on whether they were properly justified.  However, we see that there are no restrictions on 
members that continue to approve emergency authorisations for the same substances, for the 
control of the same pests, and on the same crops for which the EFSA concluded that the approval 
was not properly justified.  In the reply received from the EU to t he comments made by Paraguay on 
notification G/TBT/N/EU/908 , the EU mentions that when the EFSA finds that the emergency 
authorization is not justified the EU takes measures to avoid repetition of emergency authorizations 
but it only indicates two specific cases.  
2.301.   In this regard, we would like to know how these measures adopted by the EU operate? Is 
the opinion of the EFSA not binding? Are regulations required to make them binding? This takes 
account of the fact that, as we previously m entioned, we have identified a number of cases in which 
they continue to be authorized.  The EFSA further considers that emergency authorizations are 
justified when the need to avoid pest resistance is proven and if there are no chemical alternatives 
to con trol a particular pest. The same arguments are used by Paraguay and other Members for whom 
there is no possibility of emergency authorizations.  Lastly, we would like to receive more information 
on the recent ruling by the European Court of Justice confirmi ng that EU member countries cannot 
make exemptions regarding the use of seeds treated with plant protection products expressly 
prohibited by EU legislation specifically referring to some of these substances.  This takes particular 
account, for example, of a  recent emergency authorization for the substance thiamethoxam granted 
by Romania on 21  December  2022 for the period 1  March  2023 - 30 May 2023 for the treatment of 
seeds.  G/TBT/M/89  
 
- 71 - 
 
  2.302.   The representative of Australia  provided the following statement. Australia thanks t he 
European Union (EU) for notifying members of the proposed regulation in document 
G/TBT/N/EU/908  on the draft regulation for the neonicotinoid insecticides clothianidin and 
thiamethoxam, to which Australia provided comments. Australia reiterates the  concerns expressed 
in our submission. The draft regulation considers environmental impacts in exporting countries when 
setting import MRLs and assessing requests for import tolerances. Australia recognises the right of 
WTO Members to regulate agricultural  imports in a manner that protects animal, plant and human 
health and the environment. However, Members are also bound by WTO obligations, particularly in 
relation to undertaking science -based risk assessments and ensuring that measures are no more 
trade-restrictive than necessary. Australia does not support using MRLs on imported products to 
achieve environmental outcomes outside the EU's borders. This extra -territorial approach impacts 
the ability of third countries to implement environmental policies con sistent with their unique 
environmental circumstances.  
2.303.   National authorities of third countries are best placed to ensure that pesticide application is 
undertaken in a responsible and sustainable manner in each country, and in accordance with their 
unique e nvironment. Australia is concerned about the limitations of the 2018 European Food Safety 
Authority risk assessments cited by the EU in the draft regulation. These studies have been used to 
support a link between the lowering of MRLs to the limit of determ ination and pollinator health. We 
request the EU provides robust scientific evidence in support of this conclusion. Australia also 
requests the EU provide information on the health of pollinators in all trading countries where the 
new MRLs are likely to ap ply. The EU may wish to consider restricting the new MRLs to only those 
countries where is has robust evidence to support its policy objective. We look forward to continuing 
to engage with the EU on this important topic.  
2.304.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
support this trade concern, originally submitted by Kenya and supported by a large number of 
Members, against the EU proposal to establish maximum residue levels (MRLs) for clothianidin and 
thiamethoxam as mechanisms for achieving environmental objectives.  In general terms, Costa Rica's 
policy is aligned with the EU objective of prioritizing environmental protection, the fight against 
climate change, and sustainable economic development, as the only viabl e path for the future of our 
planet.  However, under no circumstances must achieving these objectives come at the expense of 
the multilateralism and fundamental obligations that underpin this Organization.  The Agreement on 
Technical Barriers to Trade clearl y defines the objectives that technical regulations, standards and 
conformity assessment procedures may legitimately fulfil. We are not sure which legitimate objective 
could justify revising an MRL, an issue linked to food safety and the protection of huma n health, 
which falls within the scope of the SPS Agreement.  Therefore, we have difficulties in understanding 
EU notification G/TBT/N/EU/908 , due to the fact that this notification, while proposing to reduce 
MRLs for clothianidin and thiamethoxam, was  notified to the TBT Committee and not to the SPS 
Committee.  
2.305.   The EU states in this notification that its rationale is an "environmental concern of [a] global 
nature". Among the legitimate objectives of the TBT Agreement, we cannot find global environmental  
concerns as justification for a measure covered by this Agreement.  Addressing environmental 
concerns of a global nature is also a matter of the utmost importance to Costa Rica. However, it is 
not clear how this objective falls within the scope of the SPS and TBT Agreements.  We would like to 
thank the EU in advance for its explanations regarding this concern, which Costa Rica raises along 
with other Members.  
2.306.   The representative of Japan  provided the following statement. On 2 February 2023, the EU 
adopted new  rules which will, once applicable, lower the Maximum Residues Levels ( "MRL") of 
clothianidin and thiamethoxam in food. It is regrettable that the measures were adopted by the EU 
without due consideration of Japan and other members' concerns expressed repe atedly at TBT 
committee meetings. Japan has been communicating closely with the EU on this issue, and we 
appreciate the EU for providing written responses to our comments dated 6 July 2022. These 
responses have been useful in understanding the EU's positio n and we hope to continue 
communication with the EU to address our concerns in a cooperative manner. Japan would like to 
raise again its concerns and make requests to the EU regarding the adopted measures, and we hope 
the EU will proceed with appropriate a ctions in response to our concerns. First, the adopted measures 
lowering the MRLs of the two active substances for the purpose of protecting pollinators outside the 
EU are clearly a deviation from the current MRL setting principles, which protect human lif e or health, 
as well as from the MRL international harmonization trend. Although the EU insists that the measure G/TBT/M/89  
 
- 72 - 
 
  would not directly link to the health of citizens, Japan considers that when taking a new approach to 
the measures affecting third countries, s uch as the MRLs, it should be thoroughly discussed with 
such third countries at the relevant international fora, including the SPS Committee.  
2.307.   Second, in paragraph 20 of the preamble of the adopted regulation, it is indicated that import 
tolerance may be se t if the applicant provides scientific evidence that the use of these two active 
substances does not adversely impact pollinators. As it is not clear what kind of evidence will be 
required in the application process, and by what criteria the unacceptable r isk to pollinators is 
measured, we would like the EU to clarify these points as soon as possible. While the EU suggests, 
in its responses to Japan's comments, that the use of the active substances in permanent 
greenhouses would be an example of the specifi c conditions for the application of import tolerances, 
Japan considers that allowing application of import tolerances to only such limited situations is not 
appropriate considering the diverse environmental conditions, pesticide use, and agricultural 
produ ction practices in non -EU countries. We would also like the EU to clarify, if a third country has 
applied for import tolerance for a specific crop and has successfully established a related standard 
value, whether this value would also apply to the product  in question imported into the EU from 
other third countries. Last but not least, Japan emphasizes that the environmental conditions in each 
country are different, and the use of pesticides is regulated by the authorities of each country based 
on scientifi c evidence in consideration of the environmental conditions in each country. Japan 
reiterates its position that, by imposing the adopted measures, the EU should not make judgments 
about the appropriateness of the use of the specific pesticides under the sp ecific conditions in third 
countries.  
2.308.   The representative of Brazil  provided the following statement. Brazil thanks the European 
Union for the opportunity to comment on the proposition notified as G/TBT/N/EU/908 , that resulted 
in the publication of Com mission Regulation 2023/334, withdrawing approval of the active 
substances thiamethoxam and clothianidin and restricting the maximum residue levels in or on 
certain products. We would like to refer to the comments we have submitted to the EU. Brazil 
unders tands that the EU's current proposal goes against the commitment in Article 2.2 of the TBT 
Agreement, as it is out of the scope of such Agreement to support unilateral policies aimed at 
protecting the environment in third countries. Besides the need for fu rther discussion, under sound 
scientific basis, about the risks that thiamethoxam and clothianidin may have on bees' population 
worldwide, Brazil understands that one could not expect to extend to all countries of the world trade -
restrictive measures that do not consider the variety of local conditions, including climate and soil. 
Furthermore, there are different needs and challenges posed by agricultural production in each 
country.  
2.309.   The EU affirms that its restrictive measure would seek to avoid a supposed transfer of 
adverse effects on bees from food production in the EU to food production in non -EU countries. 
However, for Brazil, this approach is not properly considering that many countries, including Brazil, 
have rigid technical procedures for approving s ubstances. Furthermore, Brazil believes that, due to 
its extraterritorial effects, the EU proposed regulation goes against the rules and jurisprudence of 
the multilateral trade system. To highlight how it is unclear for Brazil that the trade restrictions 
proposed by the EU would be justified, thiamethoxam is one important substance used in control 
strategies of pests such as the citrus psyllid, an insect that transmits the greening disease. 
Recognized by the European Food Safety Agency (EFSA) as a priority pest for control in EFSA's List 
of Priority Pests of October 2019, greening is a major cause of losses in orange production not only 
in Brazil, but worldwide. In Brazil, the State of São Paulo is the main citrus juice producer and it is 
also where 84% of h oney production is concentrated. In that state, there is no evidence of a decline 
in the number of pollinators. On the contrary, honey production in that region has increased by 
about 136% in the last 15 years.  
2.310.   We also have a concern that if the current pr oposal for restricting the use of thiamethoxam 
and clothianidin becomes the basis for other similar restrictions, farmers in Brazil and worldwide can 
face serious problems that will affect productivity and their capacity to contribute to global food 
securi ty. Brazil appreciates the opportunity to discuss this issue with the EU and calls for the 
European Commission to consider a more balanced approach that harmonizes with the Codex 
Alimentarius' recommendations for clothianidin and thiamethoxam MRLs. Brazil also appreciates 
receiving replies to its comments but regrets that they have not been taken into account for 
publication of Commission Regulation 2023/334.  G/TBT/M/89  
 
- 73 - 
 
  2.311.   The representative of Ecuador  provided the following statement. My delegation wishes to 
express its concern about the measure notified by the European Union regarding the protection of 
pollinators by lowering the MRLs for neonicotinoids (clothianidin and thiamethoxam), of which this 
Committee was notified in July 2022.  Ecuador reiterates that the EU's regulatory proposal would not 
appear to be properly in line with Articles 2.2, 2.4 and 12.3 of the WTO Agreement on Technical 
Barriers to Trade and GATT 1994. It infringes on the regulatory policy powers of its trading par tners, 
who sovereignly set the conditions for food production and agricultural activity in their own 
jurisdictions according to their geographic differences, ecosystem conditions, agricultural output, 
scientific capabilities and development.  Thiamethoxam i s effective against nematodes and black 
aphids in banana production, and against thrips and aphids in flower production. It also leaves 
significantly less residue in the environment and decomposes much faster than other products.  
2.312.   According to the Rainfores t Alliance, the risk from the use of thiamethoxam in banana 
cultivation has been mitigated and there have been no reports of direct harm to bee populations. 
Other studies indicate that obtaining just one compound to be used as a pesticide can take more 
than 11.3 years of research and development on average and significant private investment to 
implement that. Lastly, as this is a measure that applies to third countries, the EU needs to carry 
out an analysis of the impact it would have on farmers in third co untries, as not having these 
substances as a means to protect their crops would have an adverse effect on small -scale producers. 
The EU is invited to address the concerns expressed by a number of Members on this matter, in 
order to avoid unnecessary restri ctions on trade.  
2.313.   The representative of Argentina  provided the following statement. First of all, we would like 
to thank the EU for the responses to our concerns. However, we believe that they are not sufficient. 
We therefore consider that the substantive i ssues raised by Argentina remain valid.  Argentina 
remains concerned about the consistency of this measure with WTO principles. We consider that the 
measure is inappropriate and disproportionate and that the EU's decision is an extraterritorial 
application of law because it clearly has an impact on third party decisions and a totally negative 
effect on trade, as either the European market is lost for certain products that are exported or the 
use of these pesticides must be stopped in the territory of the exp orting countries, even if their use 
is required on account of climate and production conditions, etc., to maintain the market and bees 
are not affected by them.  If this is not the case, could the EU indicate what non -EU countries should 
do to continue usin g neonicotinoids if they are necessary and to continue exporting products to the 
EU that have been treated with them? We understand that if the EU did not intend to achieve an 
application of its measure outside the EU, it should have examined other measure s. Could the EU 
indicate whether it did? And how did it examine the proportionality of the measure that it intended 
to implement?  
2.314.   We reiterate that the EU has established an MRL at the level of detection to protect bees, 
when MRLs are actually adopted to e nsure food safety, not to protect the environment. The Codex 
Alimentarius recently adopted new MRLs for neonicotinoids, demonstrating that they are safe for 
consumers.  The EU's decision is therefore inappropriate and inconsistent with WTO principles and is  
disproportionate, since trade in certain products will be significantly affected if it is decided to 
continue applying these products.  In its response to Argentina, the EU reminded us that WTO 
Members are not prevented from taking the necessary measures t o ensure the protection of animals 
or plants, health or the environment, provided that such measures are not applied in a manner that 
would constitute a means of arbitrary or unjustifiable discrimination or a disguised restriction on 
international trade. I n accordance with Article 2.2 of the TBT Agreement, technical regulations shall 
not be more trade -restrictive than necessary to fulfil a legitimate objective, taking account of the 
risks that non -compliance would create. The EU considers that the reduction  of MRLs for clothianidin 
and thiamethoxam to the limit of quantification (LOQ) is necessary to fulfil its legitimate 
environmental protection objective and that there is no alternative that is less trade -restrictive and 
likewise contributes to the objecti ve. 
2.315.   Argentina considers that the measure adopted by the EU to establish LOQ values for these 
neonicotinoids is not clearly justified and constitutes a disguised restriction on international trade 
within the meaning of Article 2.2 because it is disproportio nate to the objective that it claims to 
protect and unduly restricts trade as it prevents the marketing of any product that has been treated 
with these neonicotinoids that may exceed the LOQ, even though the EU cannot demonstrate that 
MRLs at the level est ablished by the Codex may affect the health of consumers, which ultimately is 
the intended purpose of an MRL.  G/TBT/M/89  
 
- 74 - 
 
  2.316.   The representative  of Kenya  provided the following statement. Kenya echoes her previous  
statement on this Specific Trade Concern. Kenya raised thi s as a Specific Trade Concern in the 
previous TBT Committee meeting and continues to have concerns over the same issue. While several 
references are provided in the draft regulation including Inter -governmental Science -Policy Platform 
on Biodiversity and E cosystem Services (IPBES) (2016), Kenya notes that the assessment report of 
the IPBES on pollinators, pollination and food production confirms that one single factor alone cannot 
explain the pattern of bee colony decline observed in some countries, while b ee colonies increase in 
others. Hence there is no confirmed global environmental risk arising from the two substances. The 
EU measure therefore raises serious concerns of inconsistency with the TBT Agreement Article 2.2. 
No other data available would under pin the assertion that there is a global environmental risk that 
would remain unmanaged by the current established risk mitigation measures implemented by the 
respective regulatory approvals by non -EU countries.  
2.317.   Kenya takes cognisance of the fact that envi ronmental protection is a legitimate objective 
under the WTO TBT Agreement. However, the EU regulations as proposed are more trade restrictive 
than necessary to fulfil a legitimate objective. It also fails to take into consideration, the Good 
Agricultural Practices (GAP) for legal uses in non -EU countries. Kenya is an agriculturally based 
economy, and the products are an integral tool in achieving food security and meeting public health 
objectives. Technical regulations should be based on international stan dards where they exist 
(Article  2.4 of the TBT Agreement), in the assessment of suitability for authorization of active 
substances. The European Union's policy on regulation of pesticides is in contravention of 
International Standards and principles of ris k analysis (Article 5 of SPS Agreement) and the Risk 
Analysis Principles applied by CODEX, in particular the Codex Committee on Pesticide Residues 
(CCPR). Kenya is concerned that by this proposed regulation coming into force, it sets a negative 
precedent f or application of similar approaches for regulating other substances beyond the borders 
of the EU based on environmental factors in future. This will have significant impact on international 
trade.  
2.318.   The proposed regulation notified under the TBT Agreement a ffects measures applied under 
the SPS Agreement which is contrary to Article 1.5 of the TBT Agreement. The proposed regulation 
acknowledges that existing EU MRLs and Codex MRLs are safe for consumers; thereby 
acknowledging that the proposed measures are ex panding the scope of the existing EU MRL 
regulation beyond protection of consumer and animal health. The proposed amendments on MRLs 
are more stringent than the provisions of the EU MRL Regulation 396/2005. The EU measure raises 
serious concerns of inconsi stency with the TBT Agreement Article 12.3 and GATT 1994: The EU 
measure has the effect of discriminating against the agricultural exports from developing countries, 
since the active substances are in use for agricultural production in these countries. The  EU measure 
ignores production and regulatory conditions in non -EU countries The EU fails to take into account 
the special development, financial and trade needs for developing country members.  
2.319.   Products containing Clothianidin have been registered as a See d Dresser Insecticide for the 
control of Aphids and thrips for reduction of Maize Lethal Necrosis Disease (MLND). MLND has 
contributed to the reduction of maize production in Kenya, with areas affected recording losses of 
up to 100%. In Kenya, maize consti tutes a significant basis of food security and is cultivated by both 
large and small -scale farmers. More than 90% of the Kenyan population relies on it for income, 
human consumption, and raw material for industrial uses. Among the diseases, MNLD has emerge d 
as the single most important production constraint in maize and other crops. In light of the above 
the proposed measure would be deemed to be in contravention of Art icle 12.3 of the TBT Agreement 
which requires that "Members shall, in the preparation and  application of technical regulations, 
standards and conformity assessment procedures, take account of the special development, financial 
and trade needs of developing country Members, with a view to ensuring that such technical 
regulations, standards and conformity assessment procedures do not create unnecessary obstacles 
to exports from developing country Members". Kenya requests the European Union to consider the 
withdrawal of the Regulation as the measure is more trade restrictive than necessary.  
2.320.   The re presentative of New Zealand  provided the following statement. New Zealand, like 
other Members, remains concerned with the EU's proposed regulation and implementation 
mechanism, relating to the neonicotinoid insecticides clothianidin and thiamethoxam notifi ed to 
Members in document G/TBT/N/EU/908 . New Zealand shares worldwide concern for the decline of 
pollinators given their vital role in supporting ecosystem functions and food production. However, 
the extent of this pollinator decline varies considera bly throughout the world and can be associated 
with a range of different causes. New Zealand encourages the EU, like all WTO Members, to address G/TBT/M/89  
 
- 75 - 
 
  global environmental issues, including sustainable pesticide use, by working with trading partners in 
multilate ral fora. New Zealand reiterates concerns previously raised in this Committee that 
unilaterally imposing prescriptive import measures, in a manner such as those notified, may not 
successfully achieve the intended goal, and could create unjustified trade ba rriers for trading 
partners. New Zealand maintains that national authorities have the appropriate competency with 
respect to making decisions on the sustainable use of pesticides within their country. While it is 
noted that there is a large variability in trading partners production and regulatory systems, 
reflecting their unique climate, environment, and pest and disease status, amongst other factors, 
New Zealand encourages Members to recognise that different production and regulatory systems 
can, and do, deliver desirable environmental outcomes. New Zealand encourages Members to use 
risk-based measures founded on sound science and relevant international standards, which are least 
trade-restrictive and appropriate to achieve the desired outcome.  
2.321.   The represe ntative of Guatemala  provided the following statement. We share the European 
Union's genuine interest in pollinators for the global environment, protecting ecosystems and 
biodiversity. Our concern is that this initiative is based on risk assessments used i n territory outside 
the EU, and it would appear that the objective is to regulate the use of neonecotinoids in the 
production of third countries.  It is important to note that agricultural production, in order to export 
to international markets, complies wi th different standards and good agricultural practices, which 
also includes the safe use and management of agricultural inputs. In addition, there are programmes 
to mitigate any risk of poisoning and/or contamination by complying with all necessary measure s 
and practices to ensure their proper use and that of the environment of the production plant, 
including integrated pest management and robust agricultural education on the use and effect of 
agrochemicals.  
2.322.   In addition, it is important to emphasize that po llinators are key to the production phase for 
agricultural products, such as coffee, particularly in the flowering period. We consider that the EU 
does not have a legal basis for applying environmental measures to products outside the EU, or for 
making a c hange in MRLs for substances without scientific evidence and risk analysis. Changing an 
MRL is linked to ensuring safe food, and the environmental issue does not come under the legitimate 
objective set out in the TBT Agreement; apart from this, there is th e SPS aspect of MRL reduction. 
We would appreciate clarification of this issue from the EU.  Guatemala reiterates the importance of 
conserving the environment and natural resources, and also the importance of the EU recognizing 
the use of good agricultural practices, which allows a sustainable level of production using productive 
methods and also recognizes the very different climatic characteristics of each region in global terms.  
2.323.   The representative of South Africa  provided the following statement. South Af rica would like 
to thank the European Union (EU) for taking time to respond to South Africa 's concern regarding 
draft Commission Regulation amending annexes II and V to Regulation (EC) No 396/2005 of the 
European Parliament and of the Council as regard Maximum Residue Levels for Clothianidin and 
Thiamethoxam in or on products. Response reference: 607785 of 26/01/2023. Amongst other points 
reflected in the EU response, South Africa notes the following:  That the South Africa is considering 
the respo nse. However, we would like to make the preliminary observation in terms of the average 
time for any application of the tolerance which is estimated to be an average of two years depending 
on the quality and completeness of the date and we shall provide th e response in the next meeting.  
2.324.   The representative of Uruguay  provided the following statement. Uruguay would like to 
thank the delegations of the United States, Indonesia, Australia, Colombia, Canada, India, Paraguay 
and Costa Rica for placing this speci fic trade concern on the Committee's agenda, and all those who 
submitted their views with respect to this measure.  It is rare to see so many delegations, 
representing different geographical and productive conditions and different levels of development, 
expressing such converging views on an issue in the WTO. In my delegation's view, this is something 
that deserves to be highlighted.  My delegation thanks the European Union for its replies to the 
comments submitted by Uruguay on 5 September 2022, as part of t he consultation process on this 
notification, which were received on 26 January 2023.  However, we take note of the approval without 
substantive changes, on 2 February 2023, of Regulation 2023/334 amending the MRLs for 
clothianidin and thiamethoxam, despite  the numerous comments made by some 20 trading partners 
in the aforementioned consultation process, and by many WTO Members at recent meetings of the 
Goods Council and the SPS, TBT and Market Access Committees.  
2.325.   In Uruguay, the relevant plant protection pro ducts are regulated to ensure correct, safe and 
recommended use, as part of a National Environment Plan focused on good agricultural practices.  G/TBT/M/89  
 
- 76 - 
 
  Uruguay understands that setting MRLs is the type of measure intended to protect consumer health 
from the risks arising from ingestion and that it therefore naturally falls within the scope of the SPS 
Agreement.  For such issues, the international reference body is the Codex Alimentarius Commission, 
where health -related issues are comprehensively addressed in relatio n to the adoption of MRLs, but 
there is currently no consideration of environmental aspects in its risk analyses (as confirmed by the 
Codex Secretariat and indicated in paragraph 35 of the report of the 53rd Session of the Codex 
Committee on Pesticide Resi dues (CCPR)).  Without prejudice to other European standards of the 
vast and complex European regulatory framework, in the EU the main and specific rule on MRLs for 
pesticides in food and feed is Regulation (EC) No 396/2005, Article 3(d) of which defines MR Ls as: 
"the upper legal level of a concentration for a pesticide residue in or on food or feed set in accordance 
with this Regulation, based on good agricultural practice and the lowest consumer exposure 
necessary to protect vulnerable consumers".  
2.326.   The EU i tself has repeatedly indicated to us – up to March 2022 – that, as a matter of 
principle, concerns about fixing MRLs for pesticides and any specific issue related to their 
implementation are matters that must be discussed in the SPS Committee, and not the TBT 
Committee. In that connection, the EU has notified, and continues to notify, the SPS Committee of 
successive amendments to MRLS for an increasing number of substances. Moreover, in the 
discussions on STC No. 11 yesterday in this Committee, the EU state d that it would notify any 
changes to the MRLs for sulfoxaflor to the SPS Committee57, despite the fact that the justification 
for the restrictions of use defined for that substance, as explained by the EU itself, would respond 
to very similar reasons as those put forward in the case of clothianidin and thiamethoxam. Chair, if 
this is confusing for the European Union, imagine how confusing it might be for the rest of us.  
Uruguay shares concerns about promoting the protection of pollinators, in line with env ironmental 
and biodiversity protection, and supports the establishment of regulatory environments based on 
scientific criteria, so as to avoid putting food security at risk or erecting barriers to trade. Uruguay 
reiterates its willingness to cooperate with  other Members, including the EU, to find mechanisms 
that can be used to achieve these objectives without unnecessarily restricting trade, while also 
ensuring conservation of the environment and protection of human, animal and plant health.  
2.327.   However, Urugua y still has doubts as to both the appropriateness  and the legal basis, in EU 
regulations and WTO standards, of reducing MRLs to the level of detection on the grounds of 
"environmental issues of global concern" or other issues that are not related to human health.  
Despite being aware of the importance of the environmental aspects, we understand that these are 
not included in the process for establishing MRLs as they are and must be addressed by countries 
individually in their territory using appropriate tool s, on the basis of their own productive and 
regulatory systems, environmental conditions and policies.  In addition, like other delegations, we 
are concerned that emergency authorizations for the use of these substances continue to be granted 
to producers f rom EU member States, which would appear to contradict the EU's stated aim when it 
introduced this measure, as well as being discriminatory in nature. We would be interested to know 
how the EU intends to consider emergency authorizations for these substanc es, and possibly others, 
in light of the recent ruling of 19 January 2023 of the Court of Justice of the European Union (CJEU), 
which considers such authorizations illegal in certain cases.  
2.328.   In response, the representative of the European Union  provided the  following statement. 
The EU would like to thank the intervening Members for providing comments on the Notification 
G/TBT/N/EU/908 . The EU has carefully studied all the comments received from a large number of 
trade partners and business associations and it has replied to all of the questions raised. The 
Regulation is already adopted and published in the Official Journal of the European Union.58 It will 
become applicable from 7 March 2026 in order to permit operators in third countries, especially in 
least-developed and developing countries, and food business operators, to prepare themselves to 
meet the new requirements. The EU would like to than k the different WTO Members once again for 
providing comments on this draft and hopes to have provided responses that sufficiently clarified 
the points raised. Nevertheless, having heard the number and substance of comments just presented 
 
57 "Separate action will likely be taken on MRLs, following the expiry of all grace periods for stocks, and 
a separate notification will be submitted to the SPS Committee".  
58 COMMISSION REGULATION (EU) 2023/334 of 2 February 2023 amending Annexes II and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue 
levels for clothianidin and thiamethoxam in or on certain products. OJ  L 47, 15.2.2023, p. 29 –45. G/TBT/M/89  
 
- 77 - 
 
  by EU trade partn ers, we will do our best to provide further relevant information at the next meeting 
of this Committee.  
2.1.3.28   India - Order related to requirement of Health certificate accompanied with 
imported food consignment of Milk and Milk Products, Pork and Pork Products & Fish and 
Fish Products, G/TBT/N/IND/233  (ID 78059) 
2.329.   The representative of the European Union  provided the following statement. At the outset, 
the EU would like to acknowledge that many of our questions have been answered by India, including 
in an online information session. The EU would like to thank India for recently postponing the 
entering into force of the three health certificates, until further notice as well as for providing a list 
of HS product codes associated to products/food categories. However, even if the new certificates 
are not associated to new sanitary measures: (1) given the disruption to trade associated to the 
three certificates issued by one authority; (2) given the uncertainty associated to the new certificate 
issued by another  authority in the beginning of March; (3) given the duplication of certificates 
requested by different authorities in India; (4) given the existence of different products/food 
categories associated to the certificates and to the registration of foreign foo d manufacturing 
facilities; and (5) given the importance of the competent authorities and companies in the exporting 
countries to have sufficient time to adapt to new measures, the EU would like to ask India to: Avoid 
the duplication of sanitary measures i n and associated to the different certificates for the import of 
the same products, which are required by different competent authorities of India; Clarify the 
modalities related to audits to the exporting countries, inspections of facilities, questionnair es, 
regionalization, border checks and listing of establishments associated to all the certificates, if and 
when these requirements will be made obligatory by any of the India authorities; and Notify to the 
WTO TBT and SPS Committees the above -mentioned mo dalities and all future health certificates well 
in advance of the date of their entering into force, to ensure full transparency and timely follow -up 
by all the competent authorities, producers and exporters. Finally, the EU reiterates its availability 
to cooperate with the competent authorities of India, to enhance mutual understanding and avoid 
unnecessary and unjustified disruptions to trade.  
2.330.   The representative of the United States  provided the following statement. On 3 August 2022, 
India's Ministry of Health and Family Welfare and the Food Safety and Standards Authority of India 
(FSSAI) issued notification F. No. 1829/Health Certificate/FSSAI/Imports (2021). India notified this 
measure to the WTO TBT Committee on 18 August 2022 as G/TBT/N/IND/233 . The United States 
submitted comments in response to this notification in December 2022. On 24 February 2023, FSSAI 
circulated a public notice extending the implementation of the order indefinitely. Although the 
indefinite postponement of the order is we lcome news, we expect India to follow science and risk -
based processes, as well as to take comments into account prior to finalizing the measure. We look 
forward to continuing bilateral engagement between the competent technical authorities on the 
import c ertificate requirements for pork, seafood, and dairy products with the goal of minimizing 
trade disruptions. We appreciate India's transparency through the process and will be anticipating a 
notification to the WTO if FSSAI will be implementing new certifi cation requirements for these 
products.  
2.331.   The representative of Canada  provided the following statement. Canada notes that the new 
FSSAI requirements related to export certificates for pork and fish and seafood has had adverse 
impacts on trade. However, Cana da was pleased to learn that the implementation of FSSAI's new 
certification requirements has been delayed until further notice, until competent authorities work to 
develop a joint certificate. Canada would appreciate clarification from India regarding the  
coordination between FSSAI, the Department of Animal Husbandry and Dairying, and the 
Department of Fisheries on these new certification requirements. Which competent authority will 
lead the negotiation of joint certificates? Canada notes a number of conce rns with the new FSSAI 
certification requirements which reference Indian regulations, requirements and product standards. 
Canada strongly encourages India to streamline certification requirements and base requirements 
on international standards. In additio n, Canada recalls the need to provide sufficient time between 
the adoption and entry into force of these new requirements to allow time for trading partners to 
adapt. In closing, Canada looks forward to India notifying trade partners of the joint certifica te and 
providing an opportunity to comment. Canada requests India to notify the SPS Committee of the 
 
59 For previous statements follow the thread under ID 780 . G/TBT/M/89  
 
- 78 - 
 
  joint certificate given that India's proposed regulation covers food safety measures aimed at 
protecting human health and safety.  
2.332.   The representative of Japan provided the following statement. Japan reiterates its concerns 
regarding India's Order related to requirement of health certificate accompanied with imported food 
consignment of milk, pork, fish and related products. According to the India's TBT notifi cation, the 
final date for comments for the notification was set as the middle of October 2022, and proposed 
date of adoption and entry into force of the Order was advised as 1 November 2022, which was just 
two weeks after the closing date for the comments . Then, India has announced the extension of the 
date of implementation three times, and a specific date of implementation has not announced yet. 
Although Japan appreciates India's decision on the extension of the date of implementation, we still 
think tha t India should set sufficient transition period before the implementation of the Order in 
order to allow time for exporting Members to adapt their system to the new health certificate forms. 
Lastly, Japan notes that one of the objectives of India's Order i s to ensure the safety of imported 
food products into India. If that is the case, Japan considers that India should notify the Order under 
the SPS Agreement as well.  
2.333.   The representative of Australia  provided the following statement. Australia supports the 
concerns raised by the European Union, New Zealand, the US, Canada and Japan on this issue. 
Australia respects India's commitment to protect the safety standards for food products imported 
into India. Australia thanks India for providing clarification on th e requirements of the certification 
order, including that a single certificate incorporating both FSSAI's and DAHD's requirements is 
acceptable, that certificate template components that contain duplicative commercial information 
and duplicative attestatio ns with existing certification need not be included. Australia maintains a 
well-established, robust export system and is a source of reliable, wholesome, and safe agricultural 
exports. Australia's export system is underpinned by a strong regulatory framewo rk enforced 
through compliance with Australia's export control legislation. This legislation provides trading 
partners with assurance that exported food products are free from harmful contaminants, are 
suitable for human consumption, and that importing cou ntry requirements are met.  
2.334.   Australia is eager to continue working with India to negotiate mutually agreeable health 
certification for imports of Australian pork and pork products, milk and milk products and fish and 
fish products into India. Australia enco urages India to consider an outcomes -based approach to 
health certification and take into consideration trading partners regulatory framework which, in 
Australia's case, provides the required assurance to FSSAI that India's import food safety standards 
are being met. Australia would appreciate India's assurance that existing health certification for pork 
and pork products, milk and milk products and fish and fish products, previously bilaterally agreed 
with DAHD, will continue to be accepted until certifica tion negotiations are concluded.  
2.335.   The representative of New Zealand  provided the following statement. New Zealand thanks 
FSSAI for the interactive process that was undertaken to gain approval for New Zealand certificates 
and supports their goal in ensuring India has robust food safety requirements. We would like to note 
that for future changes to certification requirements that consideration is given to longer 
implementation periods, factoring in time to consider submissions on the relevant WTO notification 
and time for countries to undertake any required assessment and im plement changes accordingly. 
A minimum of six months, but preferably twelve months, should provide countries sufficient time 
for adequate implementation. Our exporters have also had some issues with clearance by DAHD 
officials since this change and look fo rward to consolidated certification requirements that meet 
India's food safety and biosecurity needs, while also facilitating trade. New Zealand recommends 
that DAHD and FSSAI processes be coordinated prior to any new food safety certification 
requirements  to avoid duplication for no added food safety benefit.  
2.336.   In response, the representative of India provided the following statement. The requirement 
of sanitary export certificate for categories of food products as specified by the Food Authority is one 
of the mandatory requirements as per the regulatory provision prescribed in Chapter "Risk based 
framework for import clearance " under Clause 11.2(b) of Food Safety and Standards (Import) 
Regulations 2017. In pursuance of the above and to envisage robust food s afety and monitoring 
system, FSSAI has notified the requirement of Health Certificate to be accompanied with the 
imported food consignments of Milk and Milk products, Pork and Pork products, and Fish and Fish 
products. The requirement of Health Certificate  is a pre -import requirement, which is only an 
assurance provided by the Competent Authorities of exporting countries that the food products (as 
notified) are in compliance with safety requirements as specified by FSSAI. The requirement was G/TBT/M/89  
 
- 79 - 
 
  notified in WTO -TBT for comments/inputs from the Members. However, various concerns regarding 
the number of certificates and extension for implementation of the Health Certificate were received 
from the Member countries. Accordingly, considering the comments received fro m various trading 
partners, the requirement of Health Certificate has been deferred till further order.  
2.1.3.29   India - Safety requirements with respect to the Rechargeable Electrical Energy 
Storage System (REESS) for electric power train vehicles, of AIS -038 and AIS-156 (ID 
77460) 
2.337.   The representative of the European Union  provided the following statement. The EU supports 
India's efforts to improve safety of its electric vehicles' fleet. India's increasingly proactive 
involvement in the work of the UN's informal wor king group on safety of electric vehicles, in the 
recent years, is particularly lauded. The EU was glad to learn that India was preparing revision 2 to 
the AIS 038 standard, which was largely based on the requirements of UN GTR 20. The latter have 
been jud iciously developed to support continuous technological development of different battery 
architectures and solutions, while ensuring the highest levels of vehicle and battery safety. The EU 
understands that during 2022, a series of incidences of battery rel ated fires primarily in the two -
wheelers vehicles have been reported in India. This has led India to introduce amendments of the 
proposed revision 2 of the AIS 038 standard that significantly deviates from the internationally 
agreed rules, i.e. UN GTR 20. The EU regrets that to date India failed to notify to the TBT Committee 
the amendments 2 and 3 to the revision 2 of the AIS 038 standard, thus going against Article 2.9.2 
of the TBT Agreement that requires Members to notify at an early appropriate stage, w hen 
amendments can still be introduced, and comments taken into account.  
2.338.   Given that the amendments in question will have a significant effect on trade, the EU once 
more calls on India to suspend Phase 1 requirements of amendment 3 which entered into force on 
1 December 2022. The EU also requests to suspend Phase 2 requirements with planned entry into 
force, on 31 March 2023, and to notify this amendment to the WTO allowing Members customary 
60 days to present their comments in writing and take these written  comments into account. The 
EU finds amendments 2 and 3 to the revision 2 of the AIS 038 standard highly problematic, since 
they are design restrictive and require drastic changes to the design of battery systems over an 
impossibly short period of time, wh ich will lead to additional development efforts/cost for vehicle 
manufacturers without adding safety benefits. Moreover, the logic of applying specific safety 
performance requirements that are meant to address the difficulties encountered on the market of 
2 wheelers to a category of motor vehicles (four wheelers), at the least as far the EU production is 
concerned, seems highly inappropriate. The EU kindly requests India to fully align the revision 2 of 
the AIS 038 to UN GTR 20, to reconsider the lead times  imposed on the industry, and to consider 
accepting type approvals and test reports that are based on the provisions of UN GTR 20 (e.g. UNR 
100.03).  
2.339.   The representative of the Republic of Korea  provided the following statement. Korea 
appreciates this opport unity to make comments on India's amended "AIS -038 and AIS -156, Safety 
Requirements with respect to the Rechargeable Electrical Energy Storage System (REESS) for 
electric power train vehicles," which were announced on 27 September 2022 through the website of 
the Ministry of Road Transport and Highways and will be phase -implemented on 1 December 2022 
and 31 March this year. At the last WTO TBT Committee meeting in November 2022, Korea raised 
an STC regarding India's REESS Safety Requirements, which are more stringent than the current 
relevant international standards, and conveyed the three following requests: Our first request was 
to remove requirements that are not stipulated in the current UN ECE standards, namely, the 
requirements regarding "temperature se nsors," "audio -visual alarm," "active paralleling circuits," 
and "cell -to-cell spacing distance," and also revise the overly burdensome "no evidence of fire and 
explosion" requirement in line with the relevant international standard, UN ECE R100.  
2.340.   The secon d request was to revise the duplicated certification requirements according to IS 
16893 -Part 2 and also Part 3, in the way the cells used to make REESS need to be certified only 
under IS 16893 -Part 3. The third request was to revise the Automotive Industry  Standards (AIS) to 
allow charge -discharge tests for the battery cell formation to be carried out under the conditions 
declared by the manufacturers as suitable for each cell product. Although Korea has received 
confirmation via the responses from the Indi an delegation and the TBT Enquiry Point that these 
concerns have been forwarded to the competent authority for examination, we have yet to receive 
 
60 For previous statements follow the thread under ID 774 . G/TBT/M/89  
 
- 80 - 
 
  any answer from the competent authority. As the implementation date of the amended standards is 
imminent, Kor ea requests that India quickly provide answers to our previous comments. In addition, 
should there be further amendments to the standards as a result of examining our comments, it is 
also requested that India provide a transition period of at least six mon ths in consideration of the 
time for the manufacturers to adapt.  
2.341.   In response, the representative of India provided the following statement. We thank EU and 
Korea for their interest in this measure. IS 16893 -Part 2 and IS 16893 -Part 3 are identical adoption s 
of IEC 62660 -2: 2010 and IEC 62660 -3: 2016 respectively. Further, India is currently undertaking 
stakeholder consultations in the context of AIS –038 (Rev 2). The original AIS -516 has been 
formulated in alignment with UN Regulation 136 while AIS 038 (Rev 2) has been formulated in 
alignment with UN R100 (Rev 3), which is based on Global Technical Regulation GTR 20. India is a 
signatory to 1998 UN agreement for global harmonization of technical regulations but not to 1958 
UN agreement for adoption of harmoni zed UN regulations. GTR 20 group has worked on M&N 
category vehicles (four -wheeler vehicles, buses and trucks) and Phase 1 of GTR 20 is released. As 
such, the work of GTR on L category (two and three wheelers) vehicles is not yet initiated. 
Representations  were received from the Republic of Korea and European Union, highlighting that the 
additional requirements introduced in AIS -156 and AIS –038 (Rev 2) are over and above the global 
regulations and these requirements may pose a technical barrier to the tradi ng activities with India.  
2.342.   The Standards Committee reviewed the comments received from the Republic of Korea and 
EU of South Korea on amendment 3 of AIS – 156: a) The experts agree that correct reference to IS 
16893 – 3 is required. Hence, the committee agr eed South Korea's request to test cells only as per 
IS 16893 -3. b) The experts agreed that the charge -discharge current can be C/3 or higher, in reply 
to the request from South Korea. Regarding AIS -038 (Rev 2), the additional requirements of 
Amendment 3 ar e being analysed in line with the intended purpose and the comments received. 
Nearly four weeks of time will be required for a wider stakeholder consultation and for deliberation 
on the received comments. The outcome of the discussions shall then be commun icated.  
2.1.3.30   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20 , 
G/TBT/N/IND/20/Add.1 , G/TBT/N/IND/40 , G/TBT/N/IND/40/Rev.1  (ID 13361) 
2.343.   The representative of Indonesia  provided the following statement. The Indonesian 
government expresses gratitude to India for responding to its concerns at the TBT Committee 
meeting in November 2022 on the policy of restricting imports of tyre products. Unfortunately, 
Indonesia laments t hat it has not yet found a suitable way to address this issue. The policy of 
restricting tyre imports and the policy of enforcing royalties for the use of the Indian Standard mark 
on tyre products sold to third countries are both subject to further explana tion requests from the 
Government of Indonesia to the Government of India. The Indian Government changed the import 
policy for tires from "free" to "restricted," as stated in Notification No.12/2015 -2020, which was 
published by the Indian Ministry of Trade  and E -Directorate Commerce's General of Foreign Trade 
on 12 June 2020. The Indonesian government has studied these changes. In addition, we view that 
the current import policy in India has become more stringent, where every container business actor 
sent t o India needs to be sampled for customs purposes as well as fulfilling provisions related to 
warehouse registration where the imported tire products will be stored.  
2.344.   Indonesia is aware that as a result of the implementation of this policy, importers are no w 
required to send separate declarations via email regarding import restrictions for specific types and 
size categories that can be produced by domestic producers in India. They are also required to 
comply with warehouse registration requirements, and any violations will be subject to criminal 
penalties under the FTDR Act 1992. Additionally, Indonesia views the application of the 
aforementioned policy as discriminatory, since it is selectively applied to a subset of member nations 
that could potentially pos e a threat to domestic tyre producers by disrupting market access. With 
the large range of tire sizes produced in India as one of the world's main producers, the 
implementation of this policy has de facto limited the sorts of products that may be exported and 
generated unnecessary trade obstacles for tire products from Indonesia.  
2.345.   Indonesia also plans to request further information regarding the usage of a royalty policy 
or marking fees on tyres that bear the IS Mark. According to Indonesia, imposing the IS Mark 
marking charge on tyre products that will be exported to third countries is not a standard practice, 
 
61 For previous statements follow the thread under ID 133 . G/TBT/M/89  
 
- 81 - 
 
  and it could burden business players and erect unneeded trade obstacles in global trade. The 
imposition of the marking charge is unlawful and has noth ing to do with safeguarding people's health, 
safety, or preventing dishonest business activities. As stated in the requirements of Articles 2.1 and 
2.2 of the TBT Agreement, the Indonesian Government believes that the execution of these 
regulations is inco nsistent with the principle of non -discrimination and has the potential to obstruct 
international trade needlessly. Indonesia urges India to be allowed to notify and assess the 
implementation of the policy in order to ensure compliance with the rules in ef fect at the WTO. 
Indonesia believes that India can provide additional information on the subject in issue.  
2.346.   In response, the representative of India provided the following statement. We thank 
Indonesia for their continued interest in this measure. We have a lready provided responses to all 
the questions raised by Indonesia in previous Committee meetings. Since no new questions have 
been raised, we request the delegation of Indonesia to refer to our past responses. We remain open 
to discuss this issue bilatera lly. 
2.1.3.31   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022 , G/TBT/N/CHN/1023 , 
G/TBT/N/CHN/1024 , G/TBT/N/CHN/1025 , G/TBT/N/CHN/1026 , G/TBT/N/CHN/1029 , 
G/TBT/N/CHN/1313  (ID 42862) 
2.347.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea recognizes China's efforts to protect the health of its people by enhancing the effic iency of 
supervision and management of medical devices life cycle, and strengthening corporate 
responsibility through the Regulations for the Supervision and Administration of Medical Devices. 
According to China's response in the last TBT Committee meeting , it is understood that the only test 
reports that are allowed for submission are those issued by testing laboratories in China that are 
approved by the authority, and the test reports by overseas testing laboratories or internationally 
accredited testing laboratories are not accepted. Thereby, the Republic of Korea requests China to 
include "internationally accredited testing laboratories " in Article 14, "Qualified testing laboratories " 
as per Article 6.1, 6.3 and 6.4 of the TBT Agreement. The addition of "internationally accredited 
testing laboratories " in Article 14 "qualified testing laboratories " will lead to expedited entry of 
products with new, internationally -approved technologies  into China, to promote health of the 
Chinese people and to advance innovation and development of the medical device industry in China.  
2.348.   In response, the representative of China  provided the following statement. The new 
Regulations on the Supervision and Ad ministration of Medical Devices, Measures for Registration and 
filing Administration of Medical Devices, and Measures for the Registration and filing Administration 
of in Vitro Diagnostic Reagents have already been implemented. As required by the Opinions on 
Further Deepening the Reform of the Review and Approval System to Encourage Innovation of Drugs 
and Medical Devices, the above Regulations and Measures scientifically set clinical evaluation 
requirements, simplify the review and approval process, and fu rther encourage innovation and 
development of the industry, while at the same time aiming to fully carry out the registrant system, 
increase the awareness of the responsibility of enterprises, and enhance whole process supervision 
of medical devices.  
2.1.3.32   Indon esia - 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 50263) 
2.349.   The representative of the United States  provided the following statement. The United States 
continues to try to work with Indonesia, bilaterally and in multilateral settings, to ensure that 
implementation of Indonesia's Halal Product Assurance Law is achi eved in a way that is consistent 
with Indonesia's WTO obligations. We urge Indonesia to continue bilateral engagement with WTO 
Members and industry stakeholders. Unfortunately, many of our long -standing concerns remain 
unanswered. We refer Indonesia to our  previous statement from previous WTO TBT Committee 
meetings, as well as outstanding questions submitted as G/TBT/W/761 . Despite Indonesia indicating 
in November 2022 that it would respond formally through the Enquiry Point; we still have not 
received any communication from Indonesia in response to the concerns raised in this Committee. 
 
62 For previous statements follow the thread under ID 428 . 
63 For previous statements follow the thread under ID 502 . G/TBT/M/89  
 
- 82 - 
 
  We again ask Indonesia to respond to all questions and concerns laid out in the Working Document 
and past statements. We will not repeat all of our outstanding concerns here . 
2.350.   Can Indonesia confirm whether there are further implementing regulations for the Halal Law 
forthcoming, and if so, what is the expected timeline for notifying those regulations? We again ask 
that Indonesia notify these regulations when drafts become avai lable, before they take effect, and 
take stakeholder comments into account before the draft regulations are adopted and implemented. 
We understand foreign halal certifying bodies are undergoing the process of accreditation. From our 
understanding, each hal al certifying body will negotiate a list of products that they are able to certify 
with BPJPH. Can Indonesia please confirm whether foreign halal certifying bodies will be allowed to 
certify finished products? Finally, we ask Indonesia to explain what spec ific steps it is taking to 
address the concerns raised by Members in this Committee on its Halal Law. We remain committed 
to working with Indonesia to address the concerns raised by the United States and other Members 
in this Committee, and to ensure that Indonesia's halal measures do not create unnecessary 
obstacles to international trade.  
2.351.   The representative of the European Union  provided the following statement. The European 
Union reiterates its serious concerns on the Indonesian Halal Product Assurance L aw 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 EU trade with Indonesia. Th e EU invites Indonesia to consider less restrictive 
alternatives to the current, wide -ranging mandatory Halal certification and labelling, in order to 
pursue the legitimate objective of ensuring reliable information for consumers without unduly 
hindering t rade 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 cert ification bodies and 
certificates would appear unduly complex, and represent an excessive burden for economic 
operators.  
2.352.   The EU stresses the importance of ensuring the continued possibility to place non -Halal 
products on the Indonesian market. 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 clarify its approach to international 
cooperation on Halal and provide for a flexible and pragmatic process for the recognition of foreign 
Halal certification bodies and acceptance of foreign certificates, building on existing bilateral 
cooperation and working arrangements on Halal certification, provide informati on on the timeline for 
adoption and publication of the remaining measures to fully implement the Halal Law. The EU 
reiterates its willingness to continue further discussion and cooperation on Halal issues with 
Indonesia, with the aim of finding a practical  way forward and solve trade concerns.  
2.353.   The representative of Canada  provided the following statement. Canada would once again 
like to join other Members in expressing its concerns with Indonesia's Halal Product Assurance Law 
no. 33 of 2014, and its impleme nting regulations, as it continues to represent a barrier to Canadian 
exports of halal products to Indonesia. While Canada supports Indonesia's objective to provide 
Indonesian consumers the assurance that they have access to products that are certified as halal 
through a rigorous and recognized process, the broad scope of the measure, as well as the lack of 
predictability and clarity on its implementation, remain problematic. Canada appreciates that 
Indonesia has taken steps to clarify the scope of products  that will require halal certification; 
however, confusion and lack of consistency remains, for instance with respect to HS codes for 
products that require halal certification, application of the measure to frozen seafood, and which 
genetically modified pl ant products may require halal certification.  
2.354.   It is important that Canada obtains answers to these questions so its exporters can comply 
with the new halal regulatory requirements. Without full and complete information, it will be difficult 
for our exporte rs to ensure their production processes fully comply with all the ramifications of 
Indonesia's halal regime. Unfortunately, as we noted previously in this Committee, Indonesia's 
response to these issues and others remain outstanding, even though Canada rai sed these issues in 
two comment letters on notifications G/TBT/N/IDN/139  and G/TBT/N/IDN/140 . Canada would G/TBT/M/89  
 
- 83 - 
 
  appreciate if Indonesia could provide a timeline regarding when we can expect a response. In the 
meantime, Canada looks forward to pos itive developments regarding the audits of two Canadian 
halal certifying bodies, which remain outstanding and represent a key step to having Canadian 
exports of halal products to Indonesia resume. Canada requests that these audits take place as 
expeditious ly as possible, so that BPJPH and the Canadian halal certifying bodies can move forward 
with the finalization of mutual recognition agreements.  
2.355.   The representative of Switzerland  provided the following statement. As in previous meetings 
of the TBT Committee, Switzerland is following this matter with interest. We share the concerns 
expressed by other Members regarding the Indonesian Halal Product Guarantee Law No 33 of 2014 
and its  implementing provisions, which require mandatory Halal certification and labelling for a large 
range of products. While Switzerland recognizes Indonesia's legitimate objective to ensure reliable 
information for consumers related to the halal integrity of certain products, we remain concerned 
over the potential negative impact on trade and refer for details to Switzerland's previous statements 
in the TBT Committee on this matter. In particular, we stress the importance to provide flexibility 
for the recogni tion of foreign Halal certification bodies and the acceptance of foreign Halal 
certificates.  
2.356.   The representative of Australia  provided the following statement. Australia welcomes 
ongoing discussions on the Indonesian Halal Product Assurance Law No.33 of 201 4 (Halal Law). 
Australia thanks Indonesia for the informative fourth International Halal Dialogue on 7 October 2022. 
We encourage Indonesia to continue to facilitate an open and transparent dialogue with its trading 
partners to allow foreign businesses and  their valued Indonesian importers to remain adequately 
informed of the Halal Law implementation regulations. Australia would appreciate clarification from 
Indonesia on whether our existing halal assurance processes will continue to be recognized when 
the grace period for Law No. 33 of 2014 ends in 2024. Further opportunities to engage with 
Indonesia's Halal Product Assurance Organising Agency (BPJPH) on accreditation and certification 
would be beneficial. We welcome Indonesia's list of natural products tha t are exempt from the halal 
certification requirement, including fresh fruits, vegetables, grains, and some dairy products.  
2.357.   Australia would appreciate an update from Indonesia as to whether it will provide an updated 
list of products that do not require ha lal certification under the Halal Law. It is currently unclear why 
some natural products are either included or excluded. There is also uncertainty on processed 
products and food products from animals that are not slaughtered. We would welcome an 
opportuni ty to hold further technical discussions with Indonesia to clarify which products are exempt 
from halal certification. Australia thanks Indonesia for their recent confirmation at the Indonesia -
Australia Comprehensive Economic Partnership Agreement Joint Co mmittee Meeting that this 
agreement is a government -to-government agreement under the Halal Laws. We welcome further 
dialogue on the Halal Law to ensure its implementation is clear and no more trade restrictive than 
necessary.  
2.358.   The representative of New Zea land provided the following statement. New Zealand thanks 
Indonesia for its ongoing engagement on the implementation of the Halal Assurance Law and 
associated implementation regulations to date, and acknowledges Indonesia's desire to increase the 
robustnes s of the halal assurances associated with products traded to Indonesia. However, New 
Zealand stresses that the WTO process of notification and consultation should be upheld. Law 
33/2014 and its implementing regulations are not explicit regarding the requir ements for recognition 
of Overseas Halal Certification Bodies. The amendments to Law 33/2014 through additional 
regulations create uncertainty around the Law's implementation. Regulation 1 of 2023, signed 
1 February 2023, which introduces new and previousl y unknown criteria for Halal Certification 
Bodies, has not been WTO -notified and there has been no opportunity for members to provide 
comment, and for businesses and agencies to achieve conformity. This creates ongoing uncertainties 
surrounding the securit y of halal trade with Indonesia. Our previous concerns regarding Regulation 
748/2021 still stand and we will not repeat these, but emphasise the importance of adhering to 
WTO-consistent notification and consultation processes.  
2.359.   In response, the representati ve of Indonesia  provided the following statement. The 
implementation of Halal Product Assurance aims for ensuring certainty and safety aspects of halal 
products available in Indonesia and increasing added value for the industry to produce and distribute 
Halal products. Products that are mandatory to be halal certified shall bear the halal label after being 
granted halal certification by recognized halal certification body/ authority based on the principle of 
mutual cooperation, mutual recognition, and mutua l acceptance of conformity assessment in G/TBT/M/89  
 
- 84 - 
 
  accordance with international regulations and practices. The provision of requirements and 
guidelines for product certification remains under discussion and will be notified to the WTO TBT 
Committee. The non -halal i nformation is intended to help consumers identify non -halal products, 
and Indonesia would like to point out that there is no obligation to label non -halal products, but only 
to provide information on the non -halal materials contained in the product. Furthe rmore, the 
Indonesian Halal Product Assurance Agency (BPJPH) have received and welcome the initiation of 
bilateral cooperation of international halal cooperation from Members. We remain open to the 
opportunity for Members to further discuss bilaterally reg arding the implementation of Halal Law 
and the implementing regulations.  
2.1.3.33   India - Mandatory Certification for Steel Products, G/TBT/N/IND/32 , 
G/TBT/N/IND/32/Add.1 , G/TBT/N/IND/32/Add.2 , G/TBT/N/IND/32/Add.3 , 
G/TBT/W/774  (ID 22464) 
2.360.   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 applic ation procedures of IS 17404:2020 (electrogalvanized hot 
rolled and cold reduced carbon steel sheets and strips) certification under the Steel and Steel 
Products (Quality Control) Order, 2020. We appreciate that Bureau of Indian Standards (BIS) 
responded p ositively to our steel businesses for scheduling on -site inspection after our travel 
restrictions was lifted. As on -site inspection is only part of the certification process, the applicants 
are still left in a great deal of uncertainties in terms of the ce rtification timeline due to the limited 
manpower of BIS. Such uncertainties and delays have made a profound impact on bilateral trade. 
We urge India to follow Articles 5.2.1 and 5.2.2 of TBT Agreement to make transparent each of the 
application stage and s peed up on -site inspection procedures. We believe that Indian businesses 
could also benefit from good quality steel and steel products from Chinese Taipei at an early time. 
We would also like to encourage India to take into account Members' concerns and su ggestions 
stated in G/TBT/W/774  published on 11 November 2022 and consider alternative measures to 
facilitate the whole certification processes.  
2.361.   The representative of Japan  provided the following statement. The mandatory regulation IS 
11169  (Part 1) was revised and published on 21 September last year. This revision changes the 
compliance requirements and expands the scope of the steel products covered by the mandatory 
regulation IS 11169 (Part 1). Therefore, steel products that have not been  certified under the revised 
IS 11169 (Part 1) by the enforcement date cannot be exported to India. However, the revised IS 
11169 (Part 1) was put into force on 15 December last year. This meant the grace period from 
publication to enforcement was less tha n three months. It was extremely difficult for steel mills 
outside India to obtain a certification under the revised IS 11169 (Part 1) by the enforcement date. 
This is because a sufficient grace period was required for many processes involved in obtaining the 
certification, including preparation and submission of documents, production and maritime 
transportation of sample products, and arranging on -site inspections. Japan kindly requests India to 
provide a sufficient grace period to allow for the many proce sses involved in obtaining certification 
in accordance with Article 2.12 of the TBT Agreement and in consideration of Paragraph 5.2 of the 
Implementation -Related Issues and Concerns of the Ministerial Decision 2001 and Paragraph 
6.3.1.10 of the Decision an d Recommendation by the TBT Committee when establishing or amending 
mandatory regulations in the future.  
2.362.   In response, the representative of India provided the following statement. The Bureau of 
Indian Standards (BIS) is carrying out physical inspections fo r applications received from foreign 
manufacturers, where the country to be visited is facilitating the visit of fully vaccinated BIS officers 
who are carrying negative RT -PCR test report, without the requirement of quarantine. With respect 
to applications  received from Chinese Taipei, visits are being planned wherever necessary formalities 
such as payment of application charge, scrutiny of application etc., have been completed.  
2.1.3.34   China - Cybersecurity Law (ID 52665) 
2.363.   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. The 
EU requests more clarity regarding several of the implementing measures of China's Cybersecurity 
 
64 For previous statements follow the thread under ID 224 . 
65 For previous statements follow th e thread under ID 526 . G/TBT/M/89  
 
- 85 - 
 
  Law. For exa mple, 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 
in the Cybersecurity Law and has been adopted into the Data Security Law. However, the term has 
still 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 draft Identification Guideline, released on 13 January 2022, was the first 
step towards implementing this national classification system for "important data". The EU urges 
China to proceed with these guidelines, to narrowly define catalogues of sectoral important data as 
soon as possible, and take into account the submitted EU comments.  
2.364.   The EU has taken note of the publication of the Outbound Data Transfer Security Assessment 
Measures by the Cyberspace Administration of China (CAC). Several issues have been identified. 
Firstly, once the regulatory security assessment is triggered, the data handler may no longer be able 
to resort to signing a standard contract or to being certified for cross -border handling of personal 
information, transferring data across borders, even when it comes to low -risk scenarios, such as the 
intra-company transfers of employees' personal information by large MNCs. Secondly, for those that 
handle large amoun ts of personal information, even if only one piece of such information is 
transferred abroad, a regulatory security assessment will still be triggered, unnecessarily. 
Additionally, 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. While these terms may 
be defined in other pieces of legislation, the c oncerns we have raised there would also apply here. 
For example, those subject to interpretation, in particular, the vague concepts of "important data " 
and "critical information infrastructure ". It would be important to address these issues to ensure 
legal certainty. The EU urges China to take on board its comments provided.  
2.365.   The EU has also taken note of the Critical Information Infrastructure Security Protection 
Regulation, which became effective as from September 2021. The Regulation provides long -awaited  
details about how critical information infrastructure operators will be designated and what their 
responsibilities will be, in order to protect the security of the networks that they build and operate. 
Since the Cybersecurity Law came into effect in 2017,  EU companies have faced uncertainty about 
whether or not they and/or their customers would be deemed critical information infrastructure 
operators and therefore face regulatory obligations in data security, procurement, cross -border data 
flows and other a reas. However, the new Regulation does not resolve the overlap between the 
Ministry of Public Security (MPS) -administered system for network security, known as the Multi -
Level Protection Scheme (MLPS, now MLPS 2.0) and the critical information infrastructu re protection 
regime. The EU urges China to clearly distinguish between the compliance obligations – especially 
with regard to product and service procurement – applicable to Critical Information Infrastructure 
on the one hand, and to networks above MLPS L evel 3 on the other, as in reality, these two sets of 
obligations are becoming increasingly equal.  
2.366.   The EU notes the recent entering into force of the Measures for Data Security Management 
in Industry and Information Technology (for Trial Implementation). T he measures impose hard 
localization requirements for potentially extremely broad sets of data used in industry. Key 
terminology crucial to the interpretation of the Measures are vaguely defined, including "industrial 
data", "important data " and "crucial d ata". This creates considerable uncertainty. The EU encourages 
China to clarify the scope of the measures and to define this in as narrow a manner as possible. The 
EU calls on China to implement the provisions in a non -discriminatory manner, respecting the  
principles of proportionality, necessity and technology neutrality, and ensure adequate protection of 
intellectual property (IP). The EU requests that China notify draft measures concerning any sectoral 
implementation to the WTO.  
2.367.   The representative of the  United States  provided the following statement. 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. Our 
numerous, long -standing concerns are clearly laid out in our past state ments to this Committee and 
remain unaddressed. We will therefore refer the Committee to our previous statements. We will 
continue to carefully monitor China's implementation of the Cybersecurity law and related measures, 
as well as the Cryptography Law. W e look forward to continuing this important dialogue.  G/TBT/M/89  
 
- 86 - 
 
  2.368.   The representative of Japan  provided the following statement. Japan continues to have 
concerns about the Cybersecurity Law. In September 2022, the draft amendment to the 
Cybersecurity Law was published.  Japan has submitted its comments and request China to take it 
into consideration. In particular, Article 65, which has been changed in the proposed amendment, 
stipulates penalties for critical information infrastructure operators who use network products or 
services that have not undergone or passed a "cybersecurity review". While Japan understands that 
the Cybersecurity Review Measures stipulate the procedures, required documents and required 
number of days for this "cybersecurity review," there still rem ains some unclear points, such as the 
specific scope of network products, which may cause unnecessary obstacles to the market entry of 
relevant foreign vendors and service providers. We request that the above unclear points be clarified 
and that the "cyber security review" be operated in a manner consistent with the TBT Agreement. 
We are also aware that the Cross -border Data Transfer Security Assessment Measures came into 
effect in September 2022 and the Security Certification Specifications for Cross -border  Processing 
Activities of Personal Information was published in December 2022 as a subordinate regulation of 
the Cybersecurity Law and Personal Data Protection respectively.  
2.369.   First, regarding the Cross -border Data Transfer Security Assessment Measures, Japa n 
submitted comments during the public comment period. While the Measures define "general data", 
"critical data", and "core data", they do not provide objective and specific criteria for classification 
of such data. In February 2022, the Information Securi ty Technology Critical Data Identification 
Guideline was submitted for public comment, and in September 2022, the Information Security 
Technology Network Data Classification and Grading Requirements were submitted for public 
comment. Japan requests China c larify whether China intend that the classification criteria for 
"general data," "critical data," and "core data" will be defined in these national standards. In addition, 
the Security Certification Specifications for Cross -border Processing Activities of Personal 
Information requires personal data processors who engage in cross -border processing activities of 
personal information to establish a personal data protection agency and to assess the impact of 
personal data protection on activities in which perso nal information is to be provided to foreign 
recipients, and these will have a significant impact on foreign businesses that have a high necessity 
to provide personal data outside of China, and may hinder the smooth facilitation of business 
activities depe nding on their specific nature.  Since predictability is important from the perspective 
of business, we request that China take the opinions we submitted for public comment into 
consideration, and that transparent implementation is ensured.  
2.370.   The representati ve of Canada  provided the following statement. Canada would like to refer 
to its statements at previous TBT Committees and continues to have significant concerns with China's 
suite of cybersecurity and cryptography/encryption laws and related implementing regulations. The 
multiplication of implementing measures 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, namely: the Practical G uidance of Cybersecurity Standards —Technical 
Specifications for Certification of Cross -border Handling of Personal Information; the Critical 
Information Infrastructure (CII) Security Protection Regulations; the Cybersecurity Review 
Measures; the Draft Regu lations on Network Data Security; and the Draft Measures for Security 
Assessment of Cross -Border Data Transfer. Canada would like to urge China to recognize the 
concerns that have been raised by Members on this measures since 2017 and reiterate our long 
standing request for a notification of these measures, only one of which has been duly notified to 
date to this Committee.  
2.371.   The representative of Australia  provided the following statement. Australia reiterates our 
previous position regarding China's Cybersec urity Law and related laws, including the Personal 
Information Protection Law and Data Security Law. As we set out in Australia's submissions to 
China's consultation on the then proposed laws, we welcomed a number of revisions to both these 
draft laws. Non etheless, Australia still has concerns around extra -territoriality, trade retaliation, 
compliance costs for firms and the overall scope. We remain concerned about the lack of clarity 
when it comes to definitions, jurisdiction and a number of other fundamen tal elements. We continue 
to urge China to take into account the concerns of business and Members in the implementation of 
these measures and development of future measures.  
2.372.   In response, the representative of China  provided the following statement. China w ould like 
to thank Members for their interest in the Cybersecurity law of China. Cybersecurity Law came into 
effect on 1 June 2017. It is China's first basic, framework, comprehensive law in the field of network 
security. The total of seven chapters and 79  articles comprehensively and systematically establishes G/TBT/M/89  
 
- 87 - 
 
  obligations and responsibilities in cybersecurity protection for relevant authorities, network 
operators, and network users. Basic systems have been established to ensure the security of network 
products and services, network operation, network data, network information, network security 
monitoring, early warning and emergency response. The network security supervision and 
management system have been further clarified. The Cybersecurity Law provides a  legal basis for 
maintaining the security and development of cyberspace, and plays an important role in ensuring 
the security of cyberspace, purifying the cyberspace environment, and promoting the development 
of the cyber industry. Since the implementation  of the law, the public's awareness of cyber security 
has been enhanced, the legal system of cyber security has been improved, the law enforcement 
capacity in cyberspace has been strengthened, and the cyberspace has become cleaner and more 
orderly.  
2.1.3.35   China - Encryption Law of the People's Republic of China by the Office of State 
Commercial Cryptography Administration (OSCCA) (ID 53466) 
2.373.   The representative of the United States  provided the following statement. The United States 
will support other Members' inter ventions and refer to its statements on the Cybersecurity Law.  
2.374.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate its concerns relating to the Cryptography Law that came into force on 1 January 
2020. T he EU remains concerned about the wide scope of the law. These factors have already 
negatively impacted business confidence. The EU also notes, with concern, that the new law does 
not recognize China's previous commitment, made in 2000, that the cryptograp hy-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 requi rements are non -discriminatory, do not favour specific 
technologies, do not limit market access and do not lead to forced transfers of intellectual property. 
The EU urges China to guarantee the possibility for foreign invested enterprises (FIEs) to partici pate 
on an equal footing with domestic companies in the production, research, development and sale of 
cryptography products on its market, including participation by chipmakers in standardization 
bodies, including Working Group 3 of the TC260 and the SCA's  own Cryptography Industry 
Standardisation Technical Committee (CISTC). The EU requests that applications to these bodies be 
replied to in a timely manner.  
2.375.   The representative of Japan  provided the following statement. Japan continues to have 
concerns about  the Encryption Law, which is in effect as of 1 January 2020. The Encryption Law 
contains an article that prohibits requests for disclosure of source code, etc. We would like to ask a 
prohibition on requests for disclosure of algorithms as well as source c ode. We request that the 
operation of this law not impede the activities of foreign companies in China or their entry into the 
Chinese market.  
2.376.   The representative of Canada  provided the following statement. Once again, Canada 
reiterates the following points  from previous meetings of the Committee. We request a response 
from China to Canada's written comments on China's State draft of Cryptography Administration's 
cryptography regulations, which Canada provided in September 2020. We also seek further clarity,  
transparency and predictability in China's regulations and laws related to Encryption and 
Cryptography, including the definition of terms; clarification that international standards will be 
used; and further precision on the measures' scope. Finally, we u rge China to notify the draft 
regulations to this Committee and allow Members reasonable time for review and comment.  
2.377.   In response, the representative of China  provided the following statement. China would like 
to thank Members for their comments on the Encryption Law of China. The law came into force on 
1 January 2020. It clearly stipulates that the governments at all levels and relevant departments 
shall follo w the principle of non -discrimination, and treat all organizations equally including foreign -
invested enterprises that engage in commercial cryptography research, production, sales, service, 
import, export, etc. China encourages commercial cryptography tec hnical cooperation on a voluntary 
basis and according to commercial rules in the process of foreign investment. Administrative 
agencies and their staff are prohibited to force any transfer of commercial cryptography technology 
by administrative means.  
 
66 For previous statements follow the thread under ID 534 . G/TBT/M/89  
 
- 88 - 
 
  2.1.3.36   Viet Nam - Cybersecurity Measures (ID 54467) 
2.378.   The representative of Japan  provided the following statement. Japan requests that the 
security assurance obligations for devices and systems stipulated by Cybersecurity Law and Decree 
No.53/2022/ND -CP (hereinafter "Decree 53 ") be implemented in compliance with the TBT 
Agreement. We understand that at the previous Committee meeting, Viet Nam stated that the 
obligation to store data and to establish branches or representative offices in Viet Nam, as stipulated 
by the C ybersecurity Law and Decree 53, are imposed on "foreign enterprises " only if the services 
provided by "foreign enterprises " are used for an activity that is in violation of the Cybersecurity 
Law. However, Decree 53 imposes on "domestic enterprises" the obligation to store data in Viet Nam 
without such limitation. Therefore, it is undeniable under Decree 53 that Vietnamese subs idiaries 
established by "foreign enterprises " under Vietnamese laws have the potential to fall under the 
category of "domestic enterprises. " This does not result in reducing the burden on "foreign 
enterprises" that own "domestic enterprises" in Viet Nam, e ven if the obligation to store data in Viet 
Nam for "foreign enterprises" is limited, as Viet Nam pointed out at the last Committee meeting.  
2.379.   Presumably, Vietnamese subsidiaries whose parent companies are headquartered outside of 
Viet Nam, in general, colle ct and manage data in an integrated manner outside of Viet Nam. These 
subsidiaries are more likely to incur additional investment costs and other burdens and to be placed 
in de facto unfavourable competitive conditions compared to enterprises that collect and manage 
data in Viet Nam. Japanese industry has concerns based on the premise that their Vietnamese 
subsidiaries established by "foreign enterprises" under Vietnamese laws could be recognized as 
"domestic enterprises." In consideration of their concerns , Japan would like to request that Viet Nam 
take appropriate measures to address them.  
2.380.   In response, the representative of Viet Nam  provided the following statement. Viet Nam 
would like to thank Japan for its continued interest in our measure. We take note of the comments 
and will convey to the competent authority in capital for consideration and further feedback.  
2.1.3.37   China - Cosmetics Supervision and Administration Regulation and Regulation for 
Notification of Non -special Cosmetics, G/TBT/N/CHN/1310 , G/TBT/N/CHN/1311 , 
G/TBT/N/CHN/1331 , G/TBT/N/CHN/1453 , G/TBT/N/CHN/1454 , G/TBT/N/CHN/1459 , 
G/TBT/N/CHN/1460 , G/TBT/N/CHN/1515 , G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525 , 
G/TBT/N/CHN/1526 , G/TBT/N/CHN/1527 , G/TBT/N/CHN/1539 , G/TBT/N/CHN/1615 , 
G/TBT/N/CHN/1626  (ID 57668) 
2.381.   The representative of the United States  provided the following statement. It is u nfortunate 
that despite the United States and other WTO Members raising significant concerns with the 
Cosmetics Supervision and Administration Regulation (CSAR) and its implementing measures in the 
past eleven TBT Committee meetings and five meetings of th e Council on Trade in Goods, China has 
not sought to work with the United States and other WTO Members to reach resolution. The United 
States maintains that it has serious concerns with CSAR and its implementing measures' likely 
inconsistency with certain WTO obligations, including unequal treatment for imports; overly 
burdensome and disproportionate information requirements; lack of procedures to ensure the 
protection of confidential and proprietary information; duplicative in -country testing, and continue d 
challenges with transparency in the development and implementation of the CSAR measures. In 
addition to our previously raised concerns, we ask that China provide clarity on Announcement 
Number 13 of 2023, issued by the National Medical Products Administr ation on 18 January on 
matters related to the Notification and Inspection of General Cosmetics. It appears that firms 
manufacturing in China will have the option of self -testing for general cosmetics, instead of 
mandatory third -party testing, if they have a cosmetics production licence and they meet additional 
conditions. Please confirm if that is correct.  
2.382.   We also ask that China clarify if importers will also be given the option to self -test? Further, 
we ask that if these requirements and procedures are new , China notify them as a draft to the WTO 
TBT Committee. As we have long noted, US industry faces pressing challenges in trying to comply 
with China's often unrealistic implementation timelines for CSAR and its conflicting technical 
regulations – complicat ed further by the lag from prior COVID -19 shutdowns over the past three 
years, and the backlogs at labs in China. In November, we asked that China consider extending by 
 
67 For previous statements follow the thread under ID 544 . 
68 For previous stat ements follow the thread under ID 576 . G/TBT/M/89  
 
- 89 - 
 
  two to three years the national CSAR implementation deadlines for the notified measures  contained 
in G/TBT/N/CHN/ 1459, G/TBT/N/CHN/1515 , G/TBT/N/CHN/1526 , and G/TBT/N/CHN/1525 , 
including extending the deadlines that have already gone into effect. We urge China to address this 
point. We also ask that China consider how it can rely more upon international recognition schemes 
for conformity assessment to red uce the timelines for companies to comply.  
2.383.   Another measure of serious concern is the Provisions for the Supervision of Cosmetics 
Sampling and Testing. We understand that China published the final measure on January 12. This 
published measure does not appea r to address the concerns expressed in the written comments 
submitted by the United States and US industry. We are particularly concerned that the seven days 
provided for companies to appeal test findings on potential noncompliance of their products with 
CSAR requirements is not sufficient. US companies remain eager for a means to engage with NMPA 
on questions arising from CSAR implementation, including regarding the new requirements and use 
of NMPA's new online platforms for product and ingredient filings.  Does China have any plans for 
this? Finally, we refer to previous US statements for other unresolved concerns and unanswered 
questions. We request that China continue to consider how these trade concerns expressed by the 
United States and many other WTO M embers may be resolved in the implementation of CSAR.  
2.384.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates China's response to Korea's comments on the Cosmetics Supervision and 
Administration Regul ation (CSAR) and its implementing regulations. We hope to continue 
cooperation to share information on cosmetic regulations. Nevertheless, Korea reiterates previous 
concerns as China's response remains limited to explaining how the measures are implemented , and 
as Korea's concerns were not duly addressed in China's finalized specifications and regulations. First, 
China's regulation states that test reports required for cosmetic product registration must be those 
issued by testing laboratories that have obta ined the China Metrology Accreditation (CMA) certificate. 
In the last TBT Committee meeting, China replied that China does not prohibit foreign inspection 
institutions from getting the certification. We would like to clarify whether it is possible for fore ign 
inspection institutions located outside China to get the CMA certificate. Also, Korea again requests 
China to adopt more flexible measures by recognizing test reports issued by qualified foreign 
laboratories located outside of the country.  
2.385.   Second, as p er Article 13 of the New Cosmetic Ingredients Authorization and Registration 
Regulation, China requires companies to prove that the test results derived from alternative test 
methods are the same with those results by in vivo  toxicity testing method, or an imal testing. With 
respect to this, Korea requests China to recognize alternative test methods approved by the OECD 
or other international organizations without requiring the submission of equivalence evidence. 
Although China replied that such requirements  are applied to both imported and domestic cosmetics, 
Korea would like to re -emphasize that our comment under this STC is asking China to recognize 
internationally -approved alternative test methods in its Regulations. Third, regarding the 
Administrative Me asures on Cosmetic Labelling, Korea requests that China to align its labelling 
requirements with international practices. China requires the labelling of ingredients with 0.1% or 
higher concentration in descending percentage order and the rest as "other tr ace ingredients ". In 
most countries, cosmetic ingredients are subject to declaration when the substances are at a 1% or 
higher concentration and the rest are not subject to labelling. Thus, China's proposed regulation is 
not in harmony with international p ractices.  
2.386.   Fourth, China requires companies to specify the sources and to provide quality data of all 
ingredients in their applications, which is more stringent than necessary compared to international 
practices. This required information often contains tra de secrets, and is more than necessary to fulfill 
China's legitimate objectives to ensure product safety and to manage China's domestic market. 
Korea therefore requests China to provide an evidence -based explanation for its measures. 
Furthermore, according  to Appendix 13 -14, businesses are required to disclose information on 
ingredient safety. Korea is concerned that the mandatory disclosure of such information may lead 
to issues in the protection of intellectual property and commercially sensitive informat ion. In the last 
TBT meeting, China responded that trade secrets and intellectual property are not damaged and 
that trade secrets are rigorously protected. With respect to this, Korea requests concrete explanation 
on how China is protecting trade secrets o f businesses. In the same vein, under the Specifications 
for Cosmetic Efficacy Claim Evaluation, it is still mandatory for businesses to disclose summarized 
scientific evidence that supports cosmetic efficacy claims on NMPA -designated websites. Since these  
information may contain trade secrets that could affect the businesses, Korea requests China to 
minimize such disclosure requirements. In the last meeting, China responded that trade secrets are G/TBT/M/89  
 
- 90 - 
 
  protected under the Regulations on the Disclosure of Governm ent Information and that the NMPA 
would strictly abide by the Regulations when managing the registration and filing of cosmetic 
products. Regarding this, Korea would like to request China to provide detailed explanation on the 
measures taken to comply with  its regulations on the disclosure of information.  
2.387.   The representative of Japan  provided the following statement. Japan appreciates China's 
response on the "Cosmetics Supervision and Administration Regulation " and its implementing 
detailed regulations in th e previous Committee meetings. However, Japan continues to express the 
following concerns, as we have stated in the previous Committee meetings and uploaded at the 
eAgenda in the Committee meeting in November 2022. Japan requests that China continue to 
address not only the matters in the statements in the meetings, but also all of the matters uploaded 
at the eAgenda.  
2.388.   1. "Management Rules for Testing required for Cosmetic Product Registration and 
Notification, " which entered into force 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 testing laboratories that are located in China 
and that have obtained CMA  (China Inspection Body and Laboratory Mandatory Approval). China's 
response in the previous TBT Committee meetings that China does not prohibit or restrict foreign 
laboratories from obtaining CMA does not meet Japan's requirements of accepting the test re sults 
of foreign laboratories with testing capability equivalent to laboratories that obtained CMA. If the 
purpose of granting CMA is for confirmation of testing capability, the location is essentially irrelevant 
to testing capability. So regardless of whe ther the location is in China or outside China, Japan would 
like to continue to request a more flexible framework through which China treat foreign laboratories 
with capability equivalent to the laboratories located in China that have obtained CMA as equal  and 
also accept test results of such foreign laboratories as equivalents.  
2.389.   2. The "Specifications for Registration and filing of New Cosmetic Ingredients " and 
"Specifications for Cosmetic Efficacy Claim Evaluation " stipulate that priority is given to test results 
in accordance with China's national standards or relevant regulations and various additional 
restrictions and conditions are imposed, such as requiring verification of equivalence with the 
established test methods in the national standards and regu lations, and storing the test results in 
order for preparation for inspections, in the case of conducting a test method which is not specified 
in the regulations. Internationally, there are test methods that are scientifically confirmed by the 
OECD and ISO  which are to be used for safety evaluation. Japan would like to request that China 
treat internationally accepted methods such as those from the OECD or ISO as equal to the methods 
stipulated in China's national standards or relevant regulations, so as no t to be more restrictive than 
necessary in proving safety and efficacy.  
2.390.   3. Especially for the following reasons, the efficacy claim evaluation method required by the 
"Specifications for Cosmetic Efficacy Claim Evaluation " is a more stringent requirement t han 
necessary for the purpose of guaranteeing the scientific validity and reliability of efficacy claim 
evaluation and protection of consumer legal interests. Japan would like to request the 
implementation of a flexible framework considering internationall y recognized practice. "Attachment 
1, Requirements of Cosmetic Efficacy Claim Evaluation item " specifies four types of evidence. It 
finely stipulates which evidence could be used for each efficacy claim. However, the scientific validity 
of limiting which e vidence is used for each efficacy item has not been demonstrated. The types of 
evidence for each efficacy claim should be determined individually by cosmetics registrants and filers 
based on the specific wording of claims and scientifically valid testing m ethod for each one, as the 
types of evidence depend on the specific wording of claims.  The scope of application of the "Guiding 
Principles of Equivalent Evaluation " as stipulated in the Specifications for Cosmetic Efficacy Claim 
Evaluation is very narrow, being limited to makeup products. Even in the case of makeup products, 
the quotation of "common efficacy claim " evaluation test data is only allowed in exceptional 
circumstances such as cases where only colorants differ in the formula of make -up series wit h 
multiple colours of the same registrants or filers. In addition, because applying "Guiding Principles 
of Equivalent Evaluation " to skincare products, hair -care products, etc. is not allowed, even if slight 
changes in a formula due to regulatory complianc e are made, retests are required. This creates 
heavy burdens for cosmetics registrants and filers. Japan would like to request that China consider 
expanding the scope of the "Guiding Principles of Equivalent Evaluation, " based on international 
trends and s takeholder opinions. Regarding the evaluation test for freckle -removing/whitening 
products, Japan would like to request that China answer the clear reason why the "Read-Across " 
approach, which allows the evaluation test to be omitted under certain conditio ns, as was proposed G/TBT/M/89  
 
- 91 - 
 
  in Article 16 (freckle -removing/whitening effect cross -reference) of the "Specifications for Cosmetic 
Efficacy Claim Evaluation (Draft for Comments) " announced in September of 2020, was removed in 
the final regulation. 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.  
2.391.   4. The Cosmetic Ingredients Safety Information includes more detailed information than 
necessa ry for the purpose of ensuring the safety and quality of final products and is stricter than 
regulations in other countries. Requirements for such overly detailed information creates heavy 
burdens for cosmetic ingredient manufacturers or cosmetics registra nts and filers. If the information 
is not submitted, it is assumed that products already on the Chinese market can no longer be sold 
or products distributed in other countries cannot be sold in China, possibly leading to a failure to 
fulfill the demands of  Chinese consumers. Japan would like to request an adequate framework for 
preventing more excessive demands than are necessary for a legitimate purpose. Especially 
regarding existing products for which application for registration or filing has occurred be fore 1 May 
2021, which is the implementation date of registration and notification under the new regulatory 
scheme, considering the large number of ingredients to be covered, it is practically impossible to 
submit the Cosmetic Ingredients Safety Informatio n by 1 May 2023. Japan would like to request 
that China provide an adequate grace period of at least one year after promulgation of all relevant 
regulations.  
2.392.   5. Japan recognizes that a transition period is set in all relevant regulations. However, we 
canno t say each transition period is long enough for the following reasons in particular. Japan would 
like to strongly request that China provide an adequate grace period of at least one year after 
promulgation of all relevant regulations and guidelines in orde r to prevent market turmoil and in 
order for cosmetics registrants and filers to adapt cosmetics to new requirements. - The 
"Specifications for Cosmetic Efficacy Claim Evaluation " stipulate that regarding cosmetics for which 
application for registration or  filing has occurred before 1 May 2021, a cosmetic efficacy claim 
evaluation must be conducted and the abstract of an efficacy evaluation of products must be 
uploaded by 1 May 2023. As mentioned in 3, considering that many conditions and restrictions are 
imposed on evaluation methods, it is practically impossible to complete an efficacy evaluation of 
products and upload the abstract by that deadline. - The "Administrative Measures on Cosmetic 
Labelling " stipulate that applications for registration or filing of products as of 1 May 2022, must be 
adapted to the regulations. It also stipulates that those products for which application for registration 
or filing has occurred before 1 May 2022, must be adapte d to the regulations by 1 May 2023. 
However, despite the impending enforcement date, all detailed rules and guidelines, which 
registrants or filers need to adapt to the new cosmetic labelling system, have yet to be stipulated.  
2.393.   6. Regarding the "Interim Mea sures on the Administration of Overseas Inspections of 
Cosmetics, " Japan would like to continue to request the following points. Japan would like to request 
that China clarify which laws and regulations are used to assess conformity and specific purposes 
for conducting foreign inspections. Japan also asks that China ensure that inspections will not be 
more trade restrictive than necessary to achieve the purpose of protecting human health. Moreover, 
information related to research and development is the most  important confidential information for 
companies, however it is not this information that directly affects product safety assurance. 
Furthermore, inspections within China are limited to the production sector and this indicates that it 
is not necessary to conduct inspections of R&D departments. Therefore, Japan requests that China 
ensure that R&D departments that may hold confidential information be excluded from the subject 
of foreign inspections. Japan also requests that confidential information not be di sclosed to persons 
other than those who are necessary for the legitimate purpose of the inspection.  
2.394.   7. The sales certification that proves the products have been sold on the market in the 
country of production is only imposed on imported cosmetics. Japan r equests that China treat 
imported products no less favourably than products that are produced in China, in other words, 
Japan requests that China abolish the obligation to acquire the sales certification that relates to 
imported products. Regarding the "Administrative Measures on Cosmetic Labelling, " which was 
promulgated on 3 June 2021, Japan would like to continue to express its following concerns.  
2.395.   8. In the TBT Committee meeting in November 2022, China explained that the content of 
the Chinese labels, su ch as information regarding only product safety and efficacy, must be 
consistent with the original labels. Japan would like to request that China clarify that the labels G/TBT/M/89  
 
- 92 - 
 
  stipulated by regulations of the country of origin do not have to be consistent with t he content of 
the Chinese labels, including information regarding product safety and efficacy.  
2.396.   9. Article 7 requires the display of "producers, " "cosmetics registrants or filers " or in the case 
of imported products, a "responsible person in China" on the product label. Japan has concerns that 
multiple company names and addresses on the label may cause misunderstandings on the part of 
consumers rather than achieving the aims of this article, which is to inform consumers of the persons 
responsible for produc t quality and efficacy. As mentioned by China at the TBT Committee meeting 
in November 2022, the "Cosmetics Supervision and Administration Regulation " clearly stipulates that 
cosmetics registrants and filers are fully responsible for quality, safety and ef ficacy claims of 
cosmetics. In order to clarify responsibilities and avoid confusion among consumers, Japan would 
like to ask that the label should indicate only a single responsible person ( "cosmetics registrants or 
filers" and if needed, a "responsible p ersons in China" as contact persons can be added). Japan 
would like to request that China delete content that requires the display of producers.  
2.397.   10. In the previous TBT Committee meetings, China explained that ingredients of 0.1% or 
less can be labelled as  "other trace ingredients" in no particular order. However, Japan is concerned 
about deviation from internationally recognized practice. With respect to the rules for labelling of all 
ingredients in cosmetics, there is an internationally recognized listing  practice that ingredients with 
a compounding amount of 1% or less are allowed to be listed in no particular order without a 
description. Japan would like to request that China assure that the rules for labelling follow the 
internationally recognized pract ice so as not to be more trade restrictive than necessary in showing 
consumers the safety and efficacy of products.  
2.398.   11. The "Specifications for Registration and filing of New Cosmetic Ingredients " and 
"Specifications for Cosmetics Registration and Filing " include stipulations about nano ingredients. To 
follow those regulations, Japan considers that a more detailed and concrete standard is necessary 
to determine which ingredients fall under the definition of nano ingredients. In addition, Japan would 
like t o request that the standard be formulated in a way that reflects international trends and 
comments from all stakeholders.  
2.399.   12. Japan understands the purpose of the sample retention system explained in the TBT 
Committee meeting in July 2022. Japan is not ag ainst sample retention per se. "Public notice related 
matters of Provisions for the Supervision and Administration of Cosmetics Production and 
Distribution " (No.140, 2021), which was promulgated on 26 November 2021, requires that, 
regarding products import ed to China from foreign registrants or filers, domestic responsible persons 
retain samples of each batch of cosmetics. Essentially, registrants or filers are responsible for the 
cosmetics in any case. Even in the case of imported cosmetics, Japan would li ke to request that 
China accept that samples do not always have to be retained in China if the testing system can be 
utilized immediately when problems occur.  
2.400.   In addition to the above, Japan would like to request that China continue to consider the 
followi ng points that have been proposed by Japan prior to this meeting: - Exemption from 
submitting toxicological testing documents via certification documents on the quality management 
system or good manufacturing practice qualifications - Restrict use of new t oothpaste ingredients 
during the safety monitoring period only when registrants or filers confirm the use in advance of 
new cosmetic ingredients - Handle efficacy evaluation reports for toothpaste by utilizing direct upload 
to the public website by registr ants or filers in the same way as cosmetics.  
2.401.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Republic of Korea, Japan, the United States, and New Zealand. 
The EU would like to refer to its earlier statements on this topic, as the EU's concerns outlined therein 
remai n unchanged. The European Union already confirmed that it supported the CSAR's objective of 
ensuring consumer safety. However, CSAR and its various implementing regulations are more 
stringent than necessary to ensure the safety and quality of imported cosm etics. In particular, this 
pertains to consumer safety and traceability of the ingredients used in cosmetics. CSAR's provisions 
diverge from international practice, as such an extensive level of information is not required 
elsewhere in the world for notifi cation and registration purposes. The obligation to transmit 
confidential information on new products and their ingredients to Chinese authorities remains one 
of EU's most important concerns. According to the EU, the mandatory disclosure of commercially 
sensitive information required in the notification and registration process, touching on intellectual 
property rights (IPR) of companies involved, goes far beyond what is required in line with G/TBT/M/89  
 
- 93 - 
 
  internationally recognized practices. Chinese measures pose signi ficant risks to companies' 
intellectual property and commercially sensitive information and are not proportionate to the 
objectives sought. The EU would like to recall that Chinese requirements go far beyond the EU's 
Cosmetics Regulation – considered to be  most stringent in the world. As regards efficacy testing, 
the multiple China -specific requirements will require significant re -testing of products for which the 
efficacy was already established in a third country. This also affects thousands of products t hat 
already have been placed on the market in China and for which the claim substantiation still needs 
to be completed.  
2.402.   The representative of New Zealand  provided the following statement. New Zealand continues 
to have concerns in relation to China's regula tory system for cosmetics which are well -documented 
in previous meetings of the TBT Committee and the Council for Trade in Goods. As we pointed out 
at the November meetings, New Zealand continues to urge China to consider additional measures 
to allow for: the exemption of animal testing requirements through non -government regulatory 
authority -issued GMP certification or other trade facilitative mechanisms for providing product 
assurances; providing flexibility in respect of product testing requirements. In particular, we 
encourage China to accept test reports from accredited laboratories situated outside of China; and 
further limitations on product disclosure requirements, particularly in relation to sensitive 
information – i.e. limited to that which is requ ired to assure product safety in China's domestic 
market, so as not to compromise intellectual property. New Zealand looks forward to engaging 
further with China on its Cosmetics Supervision and Administration Regulations (CSAR) to address 
these issues.  
2.403.   The representative of Australia  provided the following statement. Australia would like to 
reiterate our concern s from previous Committee meetings on this specific trade concern. Australia 
remains concerned that measures under China's Cosmetics Supervision an d Administration 
Regulation (CSAR) and various implementing regulations, which entered into force on 1 May 2021, 
are more stringent and trade restrictive than necessary  for low -risk cosmetics . These concerns 
include testing, registration requirements, gove rnment certification requirements and requirements 
to provide detailed information on production processes and other aspects of their intellectual 
property. The Australian Government reiterates that we are ready to work with China to discuss the 
CSAR and o ur respective systems for cosmetics regulation.  
2.404.   In response, the representative of China  provided the following statement. China would like 
to thank Members for their continued interest in the Cosmetics Supervision and Administration 
Regulation and Regulat ion for Notification of Non -special Cosmetics. Regarding the inspection 
required for cosmetics registration and notification. Requiring the inspection for cosmetics 
registration and notification to be carried out by professional institutions aims to protec t consumers' 
rights and ensure the accuracy of the inspection results. Inspection institutions shall obtain the 
certification of inspection and testing qualification (CMA) in the field of cosmetics. However, China 
does not prohibit foreign inspection insti tutions from getting the certification, and China's 
Administrative Measures for the Accreditation of Inspection and Testing Institutions do not restrict 
foreign inspection institutions from getting such certificates either. 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 the 
alternative programs of animal tests for safety evaluation.  For both domestic and imported ordinary 
cosmetics, the toxicological test can be replaced with safety risk assessment once they have obtained 
quality management system certification issued by government authorities.  
2.405.   Regarding the evaluation of cosmetic ef ficacy claims. The formulation of the specification for 
the Evaluation of Cosmetic Efficacy Claims is to further ensure the scientificity, accuracy and 
reliability of the evaluation of cosmetic efficacy claims, safeguard the rights and interests of 
consume rs, and promote social co -governance and the healthy development of the cosmetics 
industry. The Regulations on the Supervision and Administration of Cosmetics and the Specifications 
and other supporting regulations clearly require that the claims of cosmet ic efficacy should be based 
on sufficient scientific evidence. Based on the principle of equivalence, the test method of efficacy 
claim evaluation does not make much limitations as to selecting the evaluation methods. Cosmetic 
registrants may, by themselve s or through entrusted competent evaluation institutions, carry out 
cosmetic efficacy claim evaluation according to relevant requirements set in Cosmetic Efficacy Claim 
Evaluation Project Requirement and Technical Guidelines for Cosmetic Efficacy Claim Eva luation. The 
specific requirements for the equivalent evaluation of freckle removing and whitening efficacy have 
been clearly defined by the contents of "equivalent evaluation of efficacy claim " in the Test Method G/TBT/M/89  
 
- 94 - 
 
  of Cosmetic freckle removing and whitening  Efficacy and the Specification for Evaluation of Cosmetic 
Efficacy claims and other supporting documents  
2.406.   Regarding cosmetics labelling -related issues. The information of cosmetics manufacturers 
includes the relevant information of the manufacturers and th eir locations, etc. Requiring the 
labelling of the information of manufacturers is an important measure to protect consumers' right 
to know, as well as an important means to promote social co -governance and crack down on 
counterfeiting and shoddy products.  The Regulations on the Supervision and Administration of 
Cosmetics clearly stipulate that the registrant of cosmetics is responsible for the quality and safety 
of cosmetics. The Measures for the Administration of Cosmetics Labels stipulates that ingredien ts 
with weight percentage not exceeding 0.1% (w/w) should be labelled with "other trace ingredients " 
as indicating words. The Measures does not require a descending order of ingredient content or any 
other specific order.  
2.407.   Regarding the raw material safety information related issues. Product safety is closely 
related to the safety of raw materials. It is an important measure to ensure product safety to require 
registrants to clarify the relevant information on raw materials safety when applying for registrat ion. 
Considering that it is common for enterprises to change the raw material manufacturer, the 
Provisions on the Management of Cosmetics Registration and Notification Data make corresponding 
provisions according to different situations in which the raw ma terial manufacturers of registered or 
notified products have changed: If the manufacturer of registered or notified raw materials has 
changed, the content of the raw materials used in the formula and the type and proportion of 
ingredients in the raw materi als have not changed, it only needs to maintain the raw material 
manufacturer through the registration and notification information platform; If the manufacturer of 
raw materials of registered or notified products changes, the content of raw materials in t he formula 
and the content of main functional ingredients and solvents in the raw materials do not change, and 
the type or content of minor stabilizer, antioxidant, preservative and other ingredients added to 
ensure the quality of raw materials change, onl y the change -related information shall be submitted, 
not all the information. In order to facilitate the cosmetics registrant to fill in the raw material safety -
related information, it is made clear in the Regulations on the Administration of Cosmetics 
Registration and Recordholder issued by the State Food and Drug Administration that if the raw 
material manufacturer has already submitted the raw material safety -related information according 
to the regulations, the registrant only needs to fill in the raw m aterial submission code for 
information association.  
2.408.   Regarding the protection of trade secrets and intellectual property rights. The procedures 
and data requirements for the registration and notification of cosmetics and new raw materials are 
detailed and clear in relevant regulation papers. Requiring registrants to submit safety -related 
materials is also a common practice aiming for the safety review of health -related products in various 
Members . It is exactly for the purpose of protecting the intellectual  property rights and trade secrets 
of enterprises that in the process of formulating relevant technical documents, the evaluation data 
required of cosmetic efficacy claims only include the summary of the supporting material of the 
efficacy claims rather th an the full text. The required technical materials of new raw materials only 
cover the basic aspects, such as the names, registration number, source, composition, physical and 
chemical properties, the purpose of use, the scope of use, safe amount of use, p recautions, storage 
conditions and best before period, rather than the complete information. The authorities and 
administrative staff will strictly protect trade secrets in handling cosmetics registration, as prescribed 
by all relevant laws and regulations . 
2.1.3.38   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 59469) 
2.409.   The representative of the United States  provided the following statement. The United States 
was pleased to see the European Commission's (EC) publication and subsequent ad option of 
proposed amendments to the European Union's (EU) Medical Device Regulation (MDR), which 
address some of the concerns that the United States has previously highlighted. In particular, the 
extension of the validity of certificates under certain con ditions will help enable vital medical devices 
to remain accessible to the market as backlogs are addressed. Additionally, the extension of the 
transition periods under certain conditions is much needed to address the long queues as 
 
69 For previous statements follow the thread under ID 594 . G/TBT/M/89  
 
- 95 - 
 
  manufacturers wait for conformity assessment reviews from Notified Bodies. Finally, the deletion of 
the current "sell-off" date provision is welcomed, as it avoids unnecessary shortages and waste by 
allowing products already deemed safe to continue to be made available in the ma rket. The United 
States will continue to monitor any industry concerns around MDR following approval.  
2.410.   One area of ongoing concern is access to Notified Bodies for SMEs. The majority of medical 
device manufacturers are SMEs. However, we have heard complaint s from US -based SMEs that they 
are having trouble finding Notified Bodies to work with as Notified Bodies are prioritizing approvals 
for larger organizations. Can the EU please provide more information about specific plans to ensure 
that, moving forward, S MEs have access to Notified Bodies? Does the EU believe that the call for 
proposals to support increased capacity of Notified Bodies under the EU4Health Program will provide 
sufficient and timely solutions? Thank you again for your continued cooperation wi th the United 
States as we strive to ensure clear guidance and timely access for vital medical technologies in the 
EU market. As you know from our previous statements, the United States has voiced concerns with 
the European Medical Device Nomenclature (EMD N) system. In response to our concerns, EU has 
raised as a solution to conduct a mapping exercise between the two systems, and so far, the 
exercise, with WHO leading the effort, appears to be fraught with challenges. The United States will 
continue to moni tor the exercise with WHO, and hopes that the EU reconsiders its position by 
selecting the Global Medial Device Nomenclature system, as it was developed with the support of 
ISO and is widely adopted by the medical device industry and used by over 100 natio nal medical 
device regulators to support their activity.  
2.411.   The representative of China  provided the following statement. China has raised concerns on 
the regulations (EU) 2017/745, (EU) 2017/7456, and subsequent notifications or guidelines. We 
would like to thank the EU for replying to our suggestions; however, our relevant industry still has 
concerns on the implementation of the above regulations. 1. Article 1 of the Proposal 
G/TBT/N/EU/943  revised Article 120.2.a of the MDR, specifying the conditions under which the 
extended transition period applies to the expired certificates, but the method of proving the legality 
of the expired certificates which meet such conditions and are used in such extended transition 
period is not stipulated, which would cre ate great obstacles to supervision, marketing, sales and 
usage. Therefore, it is suggested to specify the method of proving the legality of the expired 
certificates which are used in the extended transition period, such as issuing new certificates or 
addin g relevant notes on certificates.  
2.412.   2. CS regulation does not provide a clear definition or relevant standards to "European 
equivalent group ", which would lead to inconsistent judgments between manufacturers and notified 
bodies during compliance assessment, creating high compliance risks to manufacturers. It is 
suggested to issue corresponding guidelines. 3. Due to the various categories of medical device 
products, there are certain differences among different member States in the interpretation of 
classifica tion rules and relevant guidelines. It is suggested that the EU could publish the lists of 
medical and non -medical device products, specifying information such as product name, principles 
of operation and intended usage. This will help manufacturers to acc urately determine categories of 
products, and save their preparation time and cost for products put on the market. 4. For the 
accessories, modules, and other spare parts to be sold together with medical devices, the EU has 
not issued any unified compliance  requirements, for example, whether conformity assessment 
procedures shall be carried out separately, and whether compliance certification materials shall be 
provided for customs clearance. The requirements proposed by different EU member States are not 
the same, which would create certain impacts for enterprises to enter the EU market. It is suggested 
that the EU authorities shall formulate and issue uniform and standardized compliance requirements 
for spare parts products.  
2.413.   The representative of Japan  provided the following statement. We appreciate the revisions 
to the MDR and IVDR regarding the extension of transitional measures and the elimination of 
distribution deadlines. However, the MDRs and IVDRs have the following issues, which we request 
be improve d. 1. MDR 1.1 Since the MDR's implementation dated 26 May 2021, Japanese 
manufacturers have been unable to ship new products and medical devices with new features to 
Europe. In the previous meetings, Japan stated that it had continued to be informed by sev eral 
companies that more than two years and eight months had passed since the technical document 
review had started, and it did not seem that there had been improvement. Japan also stated that it 
would like to request that the EU continue to monitor and ma ke improvements as a regulator. Japan 
appreciates the EU's response at the previous meeting that the MDCG is closely monitoring the 
situation of the reviews on the ground. However, we continue to be informed by several companies G/TBT/M/89  
 
- 96 - 
 
  that more than three years have passed since the technical document review started. It does not 
seem that there has been improvement. Japan would like to request that the EU continue to monitor 
the situation and make improvements as a regulator.  
2.414.   1.2 Strict clinical evaluation is req uired even for relatively low -risk medical devices classified 
as Class I, IIa and IIb under the MDR. Japan requests that the EU consider simplifying the clinical 
evaluation requirements for low -risk medical devices like Japanese pharmaceutical certificatio n or 
US 510(k) regulations and that, for example, the EU consider simplifying the clinical evaluation 
requirements for medical devices of medium -risk or lower using market -proven technology also from 
the viewpoint of promoting international harmonization. As requested in the previous meetings, 
Japan continues to request that the EU consider ensuring that the operation is not more trade -
restrictive than necessary. 1.3 Japan also requests that the mapping of the EMDN (European Medical 
Device Nomenclature) and  the GMDN (Global Medical Device Nomenclature) is achieved through the 
EU's active involvement in the WHO's standardized nomenclature for medical devices.  
2.415.   2. IVDR. Japan welcomes the proposal to remove the "sell -off period" of the transition period 
for dev ices requiring certification under IVDR plus one year, meaning the deadline for selling off 
products placed in the market before the end of transition period, addressed in the Regulation 
amending the transitional provisions for the MDR and the IVDR submitt ed by European Commission 
on 6 January 2023. The proposal says significant extension of the transition deadline, the end of 
2027 through the end of 2028 depending on their risk class, for devices requiring certification under 
the MDR. However, the transiti on period for devices requiring certification under the IVDR remains 
unchanged from the period extended by REGULATION (EU) 2022/112 of 26 May 2025 through 26 
May 2027. As stated in the previous meeting, Japan is deeply concerned that many manufacturers 
will not be able to complete certification by the deadline given the lack of infrastructure necessary 
for IVDR certification. According to the results from the survey on IVDR certification status of 
Japanese IVD manufacturers conducted by the Japan Associatio n of Clinical Reagents Industries in 
June and November 2022 and January 2023, approximately only 10% of IVD devices requiring IVDR 
certification have been certified as of January 2023, and the number of certified devices is only 69 
for half a year from Jun e 2022. Regarding the review period, the survey revealed that some IVD 
devices have not been certified even after 27 months have passed. Therefore, Japan would like to 
request the re -extension of the transition period for the IVDR to at least the same as t hat for the 
MDR, the end of 2027 through the end of 2028, or beyond.  
2.416.   3. MDR and IVDR 3.1 Japan appreciates the sequential publication of the guidance in line 
with the MDCG Guidance Publication Plan. However, Japan has been informed by Japanese 
manufacturer s that the requirement to conform to guidance issued immediately prior to application 
for certification is a factor that prolongs the certification audit process. In line with our statements 
in the previous meetings, Japan requests that public consultation  be carried out prior to the 
publication of MDCG guidance, and that the published MDCG guidance have a transitional period of 
at least one year, and that it be used for reviews by notified bodies after the transitional period has 
elapsed. 3.2 In the previo us meetings, Japan stated "The publication plan in the EU Official Journal 
on harmonized standards is not disclosed and are promulgated abruptly. Therefore, Japanese 
manufacturers need to develop and respond to their conformity plans urgently after the pub lication 
of harmonized standards. We request the release of the plan for the development and publication of 
harmonized standards for MDR and IVDR. " Japan requests continued consideration on the publication 
plan and setting an adequate transition period for  MDR and IVDR harmonized standards.  
2.417.   The representative of Australia  provided the following statement. Australia refers to its 
previous statements made in the TBT Committee and notes the recent decision by the European 
Parliament to extend transition timefr ames for the European Union Medical Device Regulations (EU 
MDR). Australia welcomes this extension as it will allow additional time and increased capacity to 
access appropriately designated notified bodies to transition medical devices to the new regulator y 
framework. The EU MDR impacts both Australian manufacturers accessing European markets, but 
also impacts access to Australian markets given common reliance on European conformity 
assessment certification to support marketing approval in Australia. We sti ll remain concerned about 
misalignment of components of the EU MDR with international guidance for certain medical devices 
which may result in trade barriers and burden to manufacturers who also supply their products to 
other countries including Australia.  Australia also reiterates concern about the European shift to the 
European Medical Device Nomenclature (EMDN) currently being developed, diverging from the 
internationally developed Global Medical Device Nomenclature (GMDN). Australia is concerned about 
the issues this may create for a globally harmonized Unique Device Identifier (UDI) system resulting G/TBT/M/89  
 
- 97 - 
 
  from use of EMDN in Europe, in contrast to use of GMDN in a range of other jurisdictions. Australia 
continues to be concerned about the absence of effective  arrangements for interoperability (such as 
a mapping of EMDN and GMDN codes), given the potential for duplication for industry, and impact 
on information sharing in monitoring and responding to safety concerns for patients.  
2.418.   In response, the representative  of the European Union  provided the following statement. 
The EU thanks the WTO Members for their comments on the Medical Devices Regulation (MDR) and 
in vitro Diagnostic Medical Devices Regulation (IVDR). As announced in previous Committee 
meetings, the MD R officially entered into force on 26 May 2021. It is important to underline that the 
shift between the Directives to the MDR is a gradual one, facilitated by transition periods that allow 
for medical devices in compliance with the Directives to continue t o be in circulation until May 2024, 
in parallel with MDR certified devices. As regards the IVDR and as of May 2022, a staggered set of 
transition periods for IVDs was proposed. A measure explaining the adapted transitional provisions 
was also notified to t he TBT Committee.  
2.419.   On the subject of notified bodies, we are glad to report that as of today, we now have 36 
MDR designated Notified Bodies and eight Notified Bodies under the IVDR. Nevertheless, the EU 
remains very concerned about the current level of not ified body capacity and preparedness of 
medical device manufacturers, and is committed to continue working closely with all relevant 
economic operators and partners to further mitigate the situation and avoid shortages of critical 
devices. The EU is fully determined to ensure 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 in order to ensure trade continuity.  
2.1.3.39   Qatar - Ministry of Public Health Circu lar regarding shelf life for cheese (ID 
60270) 
2.420.   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 ultra -heat treatment (UHT) milk and white cheese that 
entered into force already in 2019 and followed later by additional circulars issued by Qatar on this 
issue. These trade restrictive measures are still kept in place to date. One of the  main EU concerns 
as regards these import conditions is the short shelf -life period imposed for several dairy products, 
including milk, cheese and butter, which do not seem to be based on science nor on international 
standards. In practice, it is impossibl e for EU exporters to continue shipping certain dairy products 
to Qatar under these conditions. At the same time, local dairy producers in Qatar are favoured as 
they are not affected by the long transport time that foreign exporters need for shipping their  dairy 
products to the country, and thus can comply with shorter shelf -life periods. The European Union 
would like to refer to mutual exchanges on this important concern, however, despite the continued 
positive dialogue, the import measures are still in pl ace. During our dialogue on this matter, Qatar 
signalled to be working on a solution to be offered in near future. We stand ready to continue working 
constructively with Qatar in order to resolve this important issue in due course.  
2.421.   The representative of New Zealand  provided the following statement. New Zealand continues 
to support the EU concerns raised in this Committee and requests the scientific evidence behind the 
assessment that resulted in such restrictive shelf -life requirements.  
2.422.   In response, the rep resentative of Qatar  provided the following statement. Qatar has taken 
note of the continued concern of the European Union, New Zealand, and the United States regarding 
Qatar 's Ministry of Public health circular on quality standards for certain dairy products and thanks 
them for their interests in this matter. Qatar has been holding very constructive discussions on this 
matter with the European Union, last of which was the succ essful EU -Qatar Workshop on dairy 
products hosted by the European Union in Brussels last month. This event was a great opportunity 
to explore perspectives from both sides, and provided an enriching exchange of ideas on how we 
can enhance our trade relation s. We would like to assure Members that the relevant measures apply 
equally to domestic and imported products and are therefore non -discriminatory in nature. In this 
respect, we would like to emphasize that product -specific requirements applied in the Stat e of Qatar 
do not prevent the importation and sale of any products that meet quality standards and thus do 
 
70 For previous statements follow the thread under ID 602 . G/TBT/M/89  
 
- 98 - 
 
  not have a significant effect on trade.  We remain available to continue our constructive discussion 
with the interested Members to provide additional  explanation where necessary.  
2.1.3.40   India - Air Conditioner and its related Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/74 , G/TBT/N/IND/110  (ID 59871) 
2.423.   The representative of China  provided the following statement. China would like to thank 
India for deferring the implementation of the Air Conditioner QCO to 1 January 2023. However, to 
date, no Chinese company has completed the factory inspection. Given that samples on -site for the 
factory inspection need to be shipped to India for in -county testing which is quite time -consuming, 
China would like to urge India to carry out and complete the factory inspection manufacturers as 
soon as possible, or further postpone the implementation of  the regulation. China appreciates India's 
efforts to increase its domestic laboratory testing capacity. India has indicated that the decision 
regarding the recognition of overseas laboratories will be taken by BIS. However, the specific process 
of recogni tion of overseas laboratories is unclear and lacks transparency. China has not known any 
laboratory recognized by BIS. We would like to urge India to provide transparent guidance, 
facilitating overseas laboratories to obtain such recognition. Lastly, China  would like to urge India to 
consider virtual and/or alternative options for inspections for those low -risk products. We are willing 
to work with India on finding solutions to the factory inspection on foreign providers.  
2.424.   In response, the representative of India provided the following statement . We thank China 
for their continued interest in this measure. The Bureau of Indian Standard (BIS) is carrying out 
physical inspections for applications received from foreign manufacturers, where the country to be 
visited is facilitating the visit of fully vaccinated BIS officers who are carrying negative RT -PCR test 
report, without the requirement of quarantine. With respect to applications received from China, 
visits are being planned wherever necessary formalities s uch as payment of application charge, 
scrutiny of application etc., have been completed. Further, Air Conditioners & its related parts 
(Quality Control) Order 2019 has been subjected to four extensions basis requests received, 
indicating that sufficient ti me has been granted to foreign and domestic manufacturers. The Air 
Conditioners and its related parts (Quality Control) Order 2019 was notified by the authorities on 
5 December 2019 with the date of implementation as 1 June 2020. The date of implementation  has 
been extended four times so far. (i) it was first extended to 1 January 2021 vide notification dated 
18 May 2020 and (ii) then to 1 January 2022 vide notification dated 22 December 2020 and then 
(iii) then to 1 January 2023 vide notification dated 8 D ecember 2021 (iv) and then to 1 October 
2023 vide notification dated 21 December 2022. This shows that India has provided sufficient time 
as well as opportunity to the manufacturers from foreign as well as domestic entities based on the 
representations fro m various foreign as well as domestic companies in order to enable them to 
comply with the mandatory Indian standards.  
2.1.3.41   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program, G/TBT/N/SAU/993/Rev.1  (ID 61572) 
2.425.   The representative 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. The EU welcomes the initia tive of the Kingdom of Saudi Arabia to 
create an integrated system that efficiently assesses the safety of imported products. We would like 
to thank the authorities of Saudi Arabia for engaging constructively in bilateral talks and providing 
some explanati ons. European stakeholders appreciate the SABER platform, however they coincide 
in reporting the overly costly, burdensome and time -consuming nature of the conformity assessment 
requirements. The sector of toys is particularly affected. In this regard, the  European Union refers 
to its previous statements. We note that some issues remain unanswered and we invite the Kingdom 
of Saudi Arabia to address these concerns and ensure efficient and less costly procedures for all 
products concerned. The European Union  would like to thank as mentioned the bilateral discussion 
we had in these days, and would appreciate if SASO could ensure a more detailed guidance to the 
Notified Bodies on how to make use of the SABER platform and therefore ensure a more consistent 
and t ransparent use of conformity assessment procedures. The European Union remains available 
to continue bilateral discussions.  
 
71 For previous statements follow the thread under ID 598 . 
72 For previous statements follow the thread under ID 615 . G/TBT/M/89  
 
- 99 - 
 
  2.426.   The representative of Canada  provided the following statement. Canada supports Saudi 
Arabia's goal of creating an integrated system that efficiently assess the safety of imported products, 
in particular for toys. Canada would like to thank Saudi Arabia for the explanation at the last TBT 
Committee in November. Industry stakeholders support SABER, however, issues continue to persist 
regarding the implementation requirements established by Notifying Bodies, which continue to pose 
unnecessary administrative burden, costs and duplicative requirements. Canada has raised some of 
these concerns at previous TBT meetings. Canada would once again  ask that Saudi Arabia's SASO 
play a more active role to monitor the notified bodies closely and ensure that they are consistent 
and transparent in administering the conformity assessment procedures. We would also request 
Saudi Arabia's consideration of pr oviding more detailed guidance to the Notified Bodies on how to 
use the SABER platform in order to increase the efficiency of the system, reduce compliance costs 
and ensure consistency.  
2.427.   The representative of Switzerland  provided the following statement. Sw itzerland would like 
to support the interventions on the "Saber Conformity Assessment Online Platform ". We remain 
concerned over the negative impact of the on bilateral trade with the Kingdom of Saudi Arabia and 
refer for details to our previous statements  in the WTO TBT Committee. The disproportionate fees 
and unnecessary administrative burdens when obtaining the required certificates from notified 
bodies authorized by Saudi Standards, Metrology and Quality Organisation (SASO), as well as the 
duplicative r equirements, remain of particular concern.  
2.428.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. The Kingdom of Saudi Arabia thanks the European Union, Canada and Switzerland for 
raising concerns regarding Saber C onformity Assessment Online Platform / Saleem Product Safety 
Program and is pleased to clarify that "Saber" is an IT Platform that aims to improve the import 
experience by easing the Conformity process/procedure before the shipment arrival. Furthermore, 
"Saber" has contributed to facilitating and enhancing trade, reducing the cost and time of custom 
clearance to 1 -7 working days compared to 7 -15 working days in previous years. As a result, Saudi 
Arabia ranking in the cross -border trade index advanced 72 ran ks, confirming Saudi Arabia's 
commitment to boosting trade facilitation. In conclusion, Saudi Arabia is always ready to collaborate 
and engage to address related issues bilaterally. The competent authority in the Kingdom (SASO) is 
willing to provide guidel ines and hold workshops for all interested trade partners and stakeholders.  
2.1.3.42   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.  G/TBT/W/774  
(ID 63273) 
2.429.   The representative of the United States  provided the following statement. In at least the last 
eight WTO TBT Committee meetings, Members have urged India to provide a means by which 
companies around the globe can resume shipments of to ys to India, without meaningful dialogue 
towards a resolution from India. We remain concerned about the clear message that India has sent 
about limiting importation of toys, regardless of where they are exported from. We ask India to 
explain to the WTO TBT  Committee what actions India is taking to address Members' concerns given 
this has been raised by at least four different Members going back to at least May 2020? In particular, 
what mechanism is India willing to implement that provides market access to e xporters whose 
factories are located in countries where BIS inspectors are not currently traveling?  
2.430.   The representative of the European Union  provided the following statement. The increasing 
number of Quality Control Orders (QCOs) across sectors is sending worrying signals to EU industry, 
EU investors, and EU member States as the majority of QCOs introduced by India appear to have 
protectionist orientation and raise question in relation to their compliance with the WTO's TBT 
Agreement obligations. The Europe an Union is deeply concerned by the fact that QCOs prescribe 
Indian specific standards where international standards already exist. With regard to the toys sector, 
we remain concerned about India's Toys Quality Control Order (QCO) ( G/TBT/N/IND/131)  and the 
certification requirements introduced by the Bureau of Indian Standards (BIS). The European Union 
refers for the record to the statements made in previous TBT Committees but would like to highlight 
today that European industry continue to report the difficulties to work through the QCO.  
 
73 For previous statements follow th e thread under ID 632 . G/TBT/M/89  
 
- 100 - 
 
  2.431.   The European industries indicates that the QCO remains challenging and the process is still 
very burdensome and complex. In addition, a huge concerns is related to the fact that the import 
policy ( G/TBT/N/IND/143)  has being applied on top of the QCO. To ensure the continued 
effectiveness of the Indian toy safety and quality regime under the QCO, the European Union would 
welcome that the Indian government considers clearly addressing and removing the curren t possible 
duplication of tests for QCO and at customs level under the DGFT notification for BIS -certified 
products. According to recent information, we understand that now only the QCO is applicable and 
that the older regime is no longer in force and ther efore there is no need of additional testing at 
customs anymore. However, we don't have a formal confirmation and we would welcome any further 
clarification in this regard. The European Union invites India to address the concerns raised and to 
alleviate th e requirement for factory audits overseas. The European Union remains available to have 
bilateral exchanges to find an adequate solution.  
2.432.   The representative of China  provided the following statement. For the Toys (Quality Control) 
Order, 2020: 1. According  to Article 3 of the Toys (Quality Control) Order, 2020, the mandatory 
certification has involved a large range of toys, that is all toys, products or materials used by children 
under 14 -year-old including swing and slide, etc. It is recommended that the I ndians can manage 
toys according to their risk level, which conducts mandatory certification to higher risk toys and 
provides other toys with a transition period. 2. The Toys (Quality Control) Act 2020 stipulates that 
the certification process is subject t o conformity testing from third -party laboratories. We thank 
India for increasing the number of accredited laboratories. However, to date, all laboratories 
accredited by India are in India, and no overseas laboratory has been accredited. Moreover, the 
ways for overseas laboratories to obtain accreditation are unclear and lack transparency. It is 
recommended that India could accept overseas laboratories (including ILAC laboratories), and 
provide transparent guidance to obtain accreditation.  
2.433.   3. Given that onl ine audits are already widely used, it is recommended that foreign factories 
could be allowed for online inspections. 4. In October 2020, the BIS issued the document of 10 Steps 
to BIS License for Toys on its official website, in which step 4 stipulated th at factories producing 
electric toys should be equipped with instruments required by IS 15644:2006 Clause 8, 9 and 10. 
However, some tests need expensive and technically demanding equipments that is difficult for small 
and medium -sized enterprises to obtai n, and these tests are often done by third -party laboratories. 
The requirement for these equipments is unnecessary and unreasonable. According to Article 5.1.2 
of the TBT Agreement, it is suggested that India could cancel the equipment requirements for ele ctric 
toys and other projects.  
2.434.   For Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy): 
1. According to Article 2 of newly revised Policy Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - 
Schedule -I (Import Policy), samples of imported toys should be randomly sent to NABL accredited 
Labs for testing in the process of clearance, which would be released when it is qualified in testing. 
It seriously affected the efficiency of customs clearance and increased the importer' s storage costs, 
which does not comply with Articles 5.1.2 and 5.2.1 of the TBT Agreement. It is recommended that 
India could exempt testing for accredited toys. 2. According to newly revised Policy Condition No. 
2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy), imported toys must be sent to a 
laboratory accredited by NABL in India. Considering that NABL is a member of ILAC, it is 
recommended that India could accept foreign laboratory test results from ILAC -accredited labs.  
2.435.   The representat ive of Canada  provided the following statement. As stated by Canada in 
previous TBT Committee meetings, the objective of India's quality control order regarding toys, as 
well as QCOs across many sectors, remains unclear. At the last two TBT Committees, whi le India 
provided updates on the number of preliminary inspections that have been conducted, Canada noted 
that India reiterated the same response on the way that QCO will be implemented, failing to address 
any of Canada's and other Members' questions and c oncerns. Canada would once again ask India to 
provide a substantive response and explain what specific actions are planned in the near future to 
have imports of toys into India resume normally.  
2.436.   In response, the representative of India provided the followin g statement. We thank the 
Members for their continued interest in this issue. The Bureau of Indian Standards (BIS) is carrying 
out physical inspections for applications received from foreign manufacturers, where the country to 
be visited is facilitating th e visit of fully vaccinated BIS officers who are carrying negative RT -PCR 
test report, without the requirement of quarantine. With respect to applications received from the 
European Union, visits are being planned wherever necessary formalities such as pay ment of G/TBT/M/89  
 
- 101 - 
 
  application charge, scrutiny of application etc., have been completed. Toys (Quality Control) Order 
2020 was notified by the authorities on 25 February 2020 with date of implementation as 
1 September 2020. The date of implementation has been extend ed to 1 January 2021 vide 
notification dated 15 September 2020. This shows that India has provided sufficient time as well as 
opportunity to the manufacturers from foreign as well as domestic entity based on the 
representations from various foreign as well  as domestic companies in order to enable them to cope 
up with the mandatory Indian Standards. We have also engaged bilaterally with some Members to 
address their concerns.  
2.1.3.43   India - Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65174) 
2.437.   The representative of the United States  provided the following statement. This is the eighth 
TBT Committee meeting in which the United States has raised concerns regarding India's Order 
mandating "non-GM (genetically modified) origin and GM free certificates " for certain agricultural 
imports into India, notified on 2 September 2020 as G/TBT/N/IND/168 . The United States once again 
acknowledges India's right and authority to regulate "GM" foods, as laid out in their Environment 
Protection Act (1986) and Rules 1989. However, the United States continues to insist that India 
provide the rationale for requiring a non -GM certificate on a per -consignment basis for each of the 
24 crops named i n the Order. In floor statements during the previous TBT Committee meeting, India 
repeated its assertion that the Order is not trade restrictive and requested that interested 
delegations provide specific trade issues being faced in respect to the Order.  
2.438.   The United States resubmits for the record that US apples experienced immediate and 
significant trade disruption upon the entry into force of the Order in March 2021, which was only 
resolved by a US state issuing a non -GM certificate. The United States has m ore recently experienced 
pronounced market access issues for US dried distillers' grains and solubles (DDGS) as well as alfalfa 
hay. India's most recent floor statement confirms that its Genetic Engineering Approval Committee 
(GEAC) has so far not issued i mport approvals for any of the named 24 -crops; GEAC has indeed 
issued few approvals of any kind since being empowered by India's Ministry of Commerce and 
Industry in 2006 to issue such approvals. The United States notes that GEAC has received multiple 
applications for DDGS import approval since 2015, and, via the establishment of a United States -
India Phytosanitary Framework Agreement in December 2021, India made a written commitment to 
waive "GMO certification requirements " for US alfalfa hay. Despite cont inued engagement with India 
on this Order, most recently during the high -level US – India Trade Policy Forum on 11 January 
2023, we have been unable to make substantive progress to resolve our concerns. The United States 
requests that India immediately rev oke this trade restrictive Order and engage in further dialogue 
with the United States to find mutually agreeable alternatives that minimize the impact on trade.  
2.439.   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 considers that the India 
requirements go beyond what is necessary to achieve the stated objective and put an additional 
burden and costs on EU exporters. The EU would invite India to exp lain why it considers necessary 
to impose such a burden on trading partners with a high prevalence of non -GM food on their domestic 
market and a robust regulatory regime governing the use of GMs. In addition to the fact that only a 
limited number of the fo od crops referred to in the Annexure are authorized to contain GMs, there 
are very strict traceability and labelling requirements applicable to food that contains GMOs. The 
Indian requirement that fresh fruit and vegetables are accompanied by a certificate  attesting to the 
GM-free nature is a redundant obligation as no authorized GMOs exist in the EU fruit and vegetable 
sectors. The additional costs that the issuance of these certificates carries for exporters, particularly 
as there is a need for a certific ate for each container in each consignment of exported fresh fruit and 
vegetables to India, are not negligible. According to the information provided by the industry, in 
2022 (with data available until October), the costs associated with GM -free certificat es to export to 
India add up to more than €105,000, impairing trade. This cost is entirely unnecessary as no fruits 
or vegetables in the EU can be genetically modified under EU legislation. Accordingly, there is no 
need for such a certificate and costs ass ociated with it. The EU would like to ask India to waive the 
requirement to attach the certificate for food items.  
2.440.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at previous TBT Committee meeti ngs, SPS Committee meetings, and the 
 
74 For previous statements follow the thread under ID 651 . G/TBT/M/89  
 
- 102 - 
 
  Council for Trade in Goods regarding the implementation of India's August 2020 Order, which 
mandates that a non -genetically modified (or GM -free) certificate accompany imported 
consignments of 24 imported food products.  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 -producing countries to export to India and unnecessarily 
restrict internatio nal trade. Canada welcomed India's 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.  
2.441.   The br oad scientific consensus is that food products derived from biotechnology that have 
undergone a rigorous scientific safety assessment according to internationally accepted guidance 
and standards are considered as safe as their conventional counterparts. Un til 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 fu rther 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.  
2.442.   The representative of Japan  provided the following statement. Japan reiterates its long -
standing concern that India's measure to require 24 agricultural products imported into India to be 
accompanied by a certificate stating that they are not of geneticall y modified origin and do not 
contain genetic modification is not based on scientific principles or proper risk assessment, and is a 
measure which is more trade -restrictive than necessary and could have negative impact on 
agricultural trade between India an d other WTO Members. In Japan, under domestic laws, the 
import, distribution, cultivation, and other general uses of genetically modified agricultural products 
for human consumption are subject to safety evaluations, and agricultural products that are not 
approved by the evaluation process could not be imported nor distributed domestically. If certain 
items are already under an appropriate control system for genetically modified agricultural products 
in the origin country, there is no scientific rationale t o require non -GM origin and GM -free certificates 
for those items. Japan therefore requests India to withdraw the requirement to the attachment of 
certificates for foods that are properly controlled in the origin country.  
2.443.   The representative of Australia  provided the following statement. Australia thanks India for 
its ongoing engagement and cooperation regarding the use of the "non-GM origin and GM free 
certificate ", as well as India's previous responses provided in the TBT Committee. Australia shares 
the vie w that GM use in agriculture needs to be safe – we are strong supporters of robust, risk and 
science -based regulation of GM. Australia reiterates that it is common international practice to 
maintain regulatory oversight and controls on agricultural crops s ubject to genetic modification. 
Requiring GM assurances on a consignment -by-consignment basis does not improve regulatory 
outcomes. In order to ensure that trade is not subject to unnecessary costs and additional regulatory 
burdens for both Australian expo rters and Indian importers, Australia requests that India implements 
alternative arrangements which recognise the existing regulatory systems in place by countries to 
control GM exports. Australia maintains appropriate regulation of GM -crops and is able to  provide 
assurances of which crops are and are not subject to GM. Australia will work with India to seek a 
mutually agreeable solution that facilitates free and open trade, in accordance with the principles of 
the recently entered into force Australia -India Economic Cooperation and Trade Agreement (AI -
ECTA). Australia looks forward to further collaborative engagement with India on this matter.  
2.444.   The representative of Argentina  provided the following statement. We thank those 
delegations who have again submitt ed this specific trade concern on the Committee's agenda and 
request that Argentina's support be recorded.  With respect to India's measure, Argentina regrets 
having again to reiterate its concern and wishes to emphasize that the measure has no scientific 
explanation that supports it.  India has not responded to the concerns raised in a timely manner by 
Argentina, so our concern regarding this measure remains valid. We refer to interventions made at 
previous meetings of this Committee.  
2.445.   The representative of Uruguay  provided the following statement. Uruguay of course 
recognizes India's right to take measures to ensure food safety and the health of its population.  
However, there should be a logical connection between the proposed measure a nd the objective G/TBT/M/89  
 
- 103 - 
 
  pursued, and in this case, beyond the answers provided by India so far, there appears to be no 
technical justification for the implementation of the proposed certification measure, taking into 
account the cited legitimate objective of ensu ring the safety and wholesomeness of imported foods.  
In this regard, note should be taken once again of the existing international consensus that 
genetically modified products, approved by exporting countries on the basis of Codex 
recommendations in relati on to the risk assessment methodology, are equivalent to their 
conventional counterparts.  Uruguay would like to reiterate how important it is for Members to 
establish measures based on scientific principles, and, in particular, for these measures to be 
implemented with the objective of minimizing negative trade effects, in line with the provisions of 
the TBT and SPS Agreements.  
2.446.   With reference to the SPS Agreement, taking into account the objective referred to above of 
ensuring the safety and wholesomeness o f imported foods, we would like to ask again why the 
reference measure is still not being notified to the SPS Committee of this Organization, despite 
having been notified to the TBT Committee.  In this regard, we take note of notifications 
G/TBT/N/IND/240  - G/SPS/N/IND/290 , submitted by India on 5 January 2023 to the TBT and SPS 
Committees, respectively, regarding the Draft Food Safety and Standards (Genetically Modified 
Foods) Regulations, 2022.  In this connection, we would like to recall tha t the Order of 21 August 
2020, establishing the certification requirement for the importation of consignments of any of the 
24 crops specified in its Annex, indicates in point 2 that this requirement is adopted to ensure that 
only non -GM food crops are imp orted into India while regulations relating to products subject to 
genetic engineering or modification are developed in accordance with Section 22 of the Food Safety 
and Standards Act of 2006.  
2.447.   The draft standard notified on 5 January 2023 refers in its rec itals, inter alia, to Section 22 
of the Food Safety and Standards Act 2006, which is the same as that referred to in the Order of 21 
August 2020. In this regard, in line with the bilateral discussions on the margins of this meeting, we 
would like to reques t India to clarify the relationship between the two measures, if there is one, 
including whether or not the recently notified draft corresponds to the standard referred to in the 
Order of 21 August 2020.  If so, does this mean that the certification require ment under the said 
Order will cease to apply once the draft standard notified on 5 January 2023, as it stands or modified, 
enters into force? If not, could India inform this Committee of the status of development of 
regulations concerning products subject  to genetic engineering or modification as provided for in 
Section 22 of the Food Safety and Standards Act of 2006?  We remain attentive to any comments 
and replies of the delegation of India in relation to the concerns of Members, as have been expressed 
for over two years by numerous delegations in both Geneva and New Delhi.  
2.448.   The representative of Paraguay  provided the following statement. Paraguay is concerned 
that this measure may create an unjustified assumption that GM  food products evaluated and 
authori zed on the basis of sound regulatory processes are less safe than non -GM food products. GM 
products have undergone rigorous scientific safety assessments in accordance with international 
standards, guidelines and recommendations to ensure that they are con sidered as safe as their 
conventional counterparts.  We r equest India, both in this Organization and in New Delhi, to 
reconsider this policy as it is not consistent with its obligations in this Organization.  We also echo 
the questions posed by Uruguay on th e recent measures notified by India and their implications for 
the implementation of the Order of 21  August  2020.  
2.449.   In response, the representative of India provided the following statement. India thanks the 
members intervening today for their interest and comments. As on date import of GM foods are not 
allowed in India (as per Environment Protection Act, 1986 and FSS Act, 2006). Therefore, to ensure 
that onl y Non -GM food crops are imported into India, FSSAI has notified the requirement of Non -GM 
certificate to be accompanied with imported food consignment, which is only an assurance provided 
by the Competent Authority of exporting country that the food crops which are not approved by 
GEAC (Genetic Engineering Approval Committee) are not imported in India and importer has to 
provide the certificate as per the format notified by FSSAI. On similar lines, India has been issuing 
such certificates for its exports to  other countries. Moreover, some countries have also established 
tolerance and traceability requirements for adventitious presence of GMOs, while others are in the 
process of developing or adopting legislation. The threshold for labelling of adventitious p resence of 
approved GM material in non -GM grain varies from 0.9% (e.g., EU) to 5% (e.g., Japan).  
2.450.   Noting the restriction of GM foods in India, the tolerance limit for adventitious presence of 
GMOs at 1% is permissible in imported food crops and the same was  notified vide FSSAI order dated G/TBT/M/89  
 
- 104 - 
 
  8 February 2021. Accordingly, import is permissible if the adventitious presence of GM content is 
less than notified tolerance limit. Further, GEAC has so far not approved any of the crop varieties of 
Genetically Modified/E ngineered origin listed on the Order mentioned above. The requirement of a 
Non-GM certificate for import of 24 food crops is an assurance required from Competent Authorities 
of exporting countries that the food crops exported to India are of Non -GM origin and GM -free. As 
on date, our several trade partners like, USA, Australia, Canada, Turkey, Iran, China, Thailand and 
EU including Italy, Germany, France are already providing requisite certificate and trade is going on 
smoothly. FSSAI is open to interact wi th trading partners for discussing the said matter in order to 
facilitate the trade.  
2.1.3.44   Republic of Korea - Revision of Safety Conformation Criteria for Textile Products 
for Infants, G/TBT/N/KOR/678  (ID 65275) 
2.451.   The representative of the European Union  provided the following statement. The EU would 
like to thank the Republic of Korea for its engagement on this issue. We would like to clarify if having 
a Korean laboratory conclude a contract with a foreign laboratory is specific to one single site of a 
testing laboratory or institution, or can be applied to an entire testing laboratory with multiple sites 
regardless of the country. We hope that Korea can assist in setting up the contact between a 
designated testing laboratory in Korea and a foreign testing  laboratory or institution, in order for the 
mutual recognition of test results and inspections to be arranged, and to solve this issue in a timely 
manner.  
2.452.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea wou ld like to thank the European Union for its continued interest regarding the "Safety 
Conformation Criteria for Textile Products for Infants" of Korea, and we would like to take this 
opportunity to respond to the STC comments raised by the EU for this TBT C ommittee meeting. 
Textile products for infants under 36 months of age must be tested and inspected by a designated 
laboratory prescribed by the "Special Act on the Safety of Children's Products" to verify that the 
product meets the safety criteria specific  to infant textile products. Korea would like to inform the 
EU that, in accordance with the requirements and procedures stipulated in Article 22.(7) of the 
Special Act on the Safety of Children's Products and Article 35 of the Enforcement Regulation of the  
aforementioned Special Act, a designated laboratory may enter into a contract with a foreign 
laboratory or institution for the mutual recognition of test results and inspections on verifying the 
safety of textile products for infants.  
2.453.   The contract for mut ual recognition is a matter between a laboratory designated under the 
Special Act and a foreign laboratory (or foreign institution), so we consider that the details of the 
contract should be addressed in the process of concluding the contract. In addition,  we inform the 
EU that there are five laboratories designated as the testing and inspection institutions for verifying 
the safety of infant textile products. They are the Korea Conformity Laboratories (KCL), the Korea 
Testing Certification Institute (KTC),  the Korea Apparel Testing & Research Institute (KATRI), the 
FITI Testing & Research Institute and the KOTITI Testing & Research Institute. If discussions about 
the contract are made between the laboratories, the Korean Agency for Technology and Standards 
(KATS) will actively cooperate under the Special Act on the Safety of Children's Products.  
2.1.3.45   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 67876) 
2.454.   The representative of the United States  provided the following statement. The United States 
submitted comments on G/TBT/N/MEX/465/Rev.1  on 3 May 2022, and has not received a response 
from Mexico. The United States remains concerned about the scope and implementation of the 
measure. Could Mexico provide a timeline for when it will respond to WTO Members' comments? We 
request  that Mexico please provide an update on the status of this measure and an estimated 
timeframe of when the revised measure will be notified to the WTO. In November, Mexico shared 
that the measure was in the final stage of review by Mexico's Ministry of Eco nomy legal team. The 
United States reiterates its request that Mexico consider allowing fatty acid analysis to be voluntary 
rather than mandatory. Currently, there are no internationally well -accepted biomarkers to 
 
75 For previous statements follow the thread under ID 652 . 
76 For previous stat ements follow the thread under ID 678 . G/TBT/M/89  
 
- 105 - 
 
  differentiate milk fat from all vegetable  fat, and there are no relevant internationally accepted testing 
methods available for this type of analysis.  
2.455.   The United States is concerned this measure may conflict with the ongoing redrafting of the 
corresponding cheese standard. How will Mexico harmoni ze 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 measure 
move forward based on Mexico 's Quality Infrastructure Law or the law it replaced, the Federal Law 
on Metrology and Standardization? Could Mexico share an outline of the different roles that each 
Ministry will play in the monitoring, compliance, and verification activities listed in t he draft measure? 
Has Mexico considered extending its eventual timeline for implementation of the measure to a period 
of at least 12 months? If Mexico proceeds with implementation of the current measure, the United 
States (Government and industry) would ne ed at least one year to launch systems to comply; 
however, we urge Mexico to delay implementation indefinitely due to continued concerns about this 
measure's scope and implementation.  
2.456.   The representative of Australia  provided the following statement. Austra lia would like to 
reiterate its concerns stared at the last six previous TBT Committee meetings that Mexico's measure 
notified as G/TBT/N/MEX/465  and associated revision appears discriminatory and more trade 
restrictive than necessary. Australia re cognizes the original objectives of the proposed measures 
and welcomes the review of the procedure in light of Mexico's international commitments. We look 
forward to receiving Mexico's reply to our comments on its revised notification. We kindly request 
an update for the release date of the new version of the procedure for public consultation.  
2.457.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
the opportunity to again speak in support of this specific trade concern rais ed by the United States. 
New Zealand considers that the conformity assessment procedures that Mexico has set out for 
cheese under NOM -223 are more trade restrictive than necessary, with some aspects of the 
conformity assessment procedure creating unnecessa ry obstacles to international trade and likely to 
cause difficulties for New Zealand exporters. We support the request for Mexico to consider less 
trade-restrictive alternatives to the measures. We look forward to receiving a response from Mexico 
to the co ncerns raised, and an update on the status of any revised version of the Conformity 
Assessment Procedure.  
2.458.   In response, the representative of Mexico  provided the following statement.  The draft 
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, was published in the Official Journal on 31  January  2022 for public consultation, 
this period expiring on 8  April 2022. However,  at the request of the Government of the United States 
of America and the European Union, this period was extended until 9  May 2022, a total of 174 
comments being received from 27 interested parties (domestic and foreign).  As a joint technical 
regulation ( Mexican Official Standard) of the Ministry of Economic Affairs (SE), regarding trade 
description and information, and the Ministry of Agriculture and Rural Development (SADER), 
regarding the substantive technical aspects of the regulation, the comments rec eived must be 
analysed and addressed by both standardizing authorities. Once these authorities have exhausted 
this process, the final version of the measure will be duly notified to WTO Members.  
2.459.   At the moment, there is no defined date for the issuance of r esponses to comments received 
during the public consultation and of the amended version of the measure, since a detailed technical 
and scientific analysis is required. The necessary communication will therefore be sought to intensify 
the work and to conclu de the technically appropriate resolution as soon as possible.  It is important 
to note that the standardization process will be conducted in accordance with the terms of the Quality 
Infrastructure Law and will be aligned with Mexican Official Standard 
NOM-223-SCFI/SAGARPA -2018. The monitoring of conformity assessment bodies will be carried out 
by the Ministry of Economic Affairs and the Ministry of Agriculture and Rural Development in a 
coordinated manner; the verification activities will be carried out by the Federal Consumer Protection 
Agency, as well as the Ministry of Economic Affairs and the Ministry of Agriculture and Rural 
Development, individually and in the exercise of their respective powers and competencies.  Lastly, 
Mexico reaffirms its commitment s on transparency under the TBT Agreement and the free trade 
agreements, thereby ensuring that the processes for the entry into force and implementation of the 
measure will observe the principles contained in the TBT Agreement and in the free trade agreeme nts 
to which Mexico is party.   G/TBT/M/89  
 
- 106 - 
 
  2.1.3.46   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1166 , 
G/TBT/N/SAU/1166/Add.2  (ID 66677) 
2.460.   The representative of the United States  provided the following statement. The United States 
appreciates Saudi Arabia's continued engagement on the "Technical Regul ation for the Restrictions 
of Hazardous Substances (RoHS) " for electrical and electronic equipment, including bilateral 
discussions this week on this matter. In particular, we appreciate the clarifications that Saudi Arabia 
has provided regarding utilizati on of the Suppliers Declaration of Conformity, and we continue to 
encourage Saudi Arabia to provide sufficient written clarifications to traders and notified bodies. As 
part of our engagement, we flagged some areas where our traders continue to seek clarif ication in 
order to help them comply with the requirements. We will follow -up in further detail directly with 
Saudi Arabia, including if implementation issues arise in the future. We have no further questions in 
the Committee on this matter at this time.  
2.461.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. The Kingdom of Saudi Arabia would like to thank the United States for their valuable 
comments on the Technical Regulation for Restriction of Hazardous Substance s. In addition, Saudi 
Arabia would like to take this opportunity and thank the United Kingdom for their remarks under the 
good news item. Also, we thank all our trade partners for the constructive engagement to solve this 
matter bilaterally. We would like to highlight that the competent authority in Saudi Arabia (SASO) 
is aiming at protecting human health and safety, and the environment, by regulating to ensure that 
hazardous substances are not above certain levels in consumer products such as EEE products.  
2.462.   For the purpose of determination of the product liability after placing the product in the Saudi 
markets, the self -declaration conformity assessment scheme will be accepted if products covered by 
the scope of the RoHS technical regulation and imported by the manufacturers or their legal 
(authorized) representative: (i) The legal representative is defined as any natural or legal person 
existed in Saudi Arabia, and who has received a written mandate from the manufacturer to perform, 
on his behalf, all or par t of the obligations and formalities connected with the technical regulations, 
including representing the manufacturer at the regulatory and judicial authorities. (ii) The tasks of 
the (Legal) authorized representative should be defined in a written mandat e. Considering the role 
of (Legal) authorized representatives, the minimum requirements they should meet should be clearly 
defined, including the requirement of having available a person who fulfils minimum conditions of 
qualification which should be simil ar to those for a manufacturer's person responsible for regulatory 
compliance. (iii) For suppliers (whom authorized by the manufacturer), it will be sufficient to 
demonstrate compliance by providing SDOC since the (Legal) authorized representative plays a 
crucial role in ensuring the compliance of the products produced by those manufacturers and in 
serving as their contact person established in the Kingdom of Saudi Arabia. In conclusion, Saudi 
Arabia is always delighted to continue collaborate and engage wi th all our stakeholder, in order to 
address related issues bilaterally.  
2.1.3.47   Republic of Korea - Regulation for supporting low carbon solar module product 
(ID 74478) 
2.463.   The representative of China  provided the following statement. China hopes that Korea could 
fully consider the reasonable demands of China's photovoltaic enterprises and take measures to 
solve China's concerns. China suggests Korea conduct LCA review of the submitted reports in 
accordance with internationally recognized standards such as ISO and disc lose the report review 
process, review time, and standards. China hopes that the Korean side could treat foreign and 
domestic enterprises and products equally, not discriminating against imported products.  
2.464.   In response, the representative of the Republic of  Korea  provided the following statement. 
Korea would like to thank China for its continued interest in the "Regulation for Supporting Low 
Carbon Solar Module Product" of Korea. Unfortunately, we have not received any advance message 
from China while prepar ing for this March Committee meeting so we regret to inform you that a 
substantive answer is not available today. Nevertheless, we will convey your comments faithfully to 
the capital for a review and an appropriate response by our competent regulatory auth ority. And in 
 
77 For previous statements follow the thread under ID 666 . 
78 For previous statements follow the thread under ID 744 . G/TBT/M/89  
 
- 107 - 
 
  this regard, if China could submit the comments in writing, our responsible authority could reply 
likewise.  
2.1.3.48   India - Approved models and manufacturers of solar photovoltaic modules order, 
2019 (ID 74279) 
2.465.   The representative of China  provided the following statement. China hopes that India can 
fully consider the reasonable demands of China's photovoltaic enterprises and adjust measures as 
soon as possible. 1. the Ministry of New and Renewable Energy of India  and the National Solar 
Energy Research Institute should publish the audit time to improve the efficiency of certification and 
treat domestic and foreign enterprises equally and fairly; The significantly increased discriminatory 
tariffs on imported photovo ltaic products should be eliminated. 2. Chinese enterprises reported that 
ALMM fees charged by India are relatively high, largely exceeding the approximate cost required for 
services as application and inspection fees, etc. India is inconsistent with Artic le VIII:1(a) of the 
GATT 1994 to control the fees. It is suggested that India should follow WTO rules  to set reasonable 
pricing, certification fees should be based on the export volume to India, rather than the total 
production capacity of the enterprise. 3. The purpose of Indian MNRE is to ensure the quality of PV 
modules has been fully met by BIS certification. The additional ALMM certification list becomes an 
obstacle to trade and manufacturers, exceeding the limits necessary to achieve legitimate object ives, 
which is inconsistent with Article 2.2 of the TBT Agreement. China suggests India reconsider the 
necessity of ALMM certification and abolish the ALMM decree.  
2.466.   In response, the representative of India provided the following statement. India has already  
provided a very detailed response on this STC in previous TBT meetings. There is no statement 
uploaded by China and hence no new concerns have been communicated. In view of this, we will 
examine the comments made today and request China to refer to the de tailed statement made by 
India in previous Committee meetings.  
2.1.3.49   India - Plastic Waste Management (Amendment) Rules, 2021 and 2022 (ID 
71980) 
2.467.   The representative of the United States  provided the following statement. As we previously 
noted, in February 2022, India's Ministry of Environment, Forest and Climate Change published in 
the Gazette of India the Plastic Waste Management (Amendment) Rules, 2022 (PWM Amendment 
Rules), which as we understand from guidance published by the Ministry, went into effect 1 July  
2022. Despite raising this issue in two previous meetings and requesting notification through the 
Enquiry Point, India has not yet notified this measure to the WTO TBT Committee. We fully support 
India's objective, like other members, to mitigate pollutio n caused by plastic waste. But such 
measures need to be enacted while upholding the transparency obligations that are central to this 
Committee. We have made our request well known and maintained that we would like to see India 
notify any relevant requirem ents and provide an opportunity for stakeholders to provide comments. 
As such, we will no longer raise this particular STC, and will attempt to seek the additional 
information that our stakeholders have requested through other means.  
2.468.   In response, the repre sentative of India provided the following statement. We thank the 
delegation of the USA for their interest in this issue. The Guidelines for Extended Producer 
Responsibility on Plastic Packaging have been notified under the Environment (Protection) Act, 19 86, 
after following due process of draft notification as mandated under law. The EPR Guidelines are not 
discriminatory and do not form a barrier to international trade. The requirements are applicable in 
a uniform manner to domestic and international compa nies. Such guidelines have also been put in 
place by other countries / regional groupings such as European Union. Further, producers, importers 
and brand owners are mandated to undertake EPR on plastic packaging introduced in the market 
since 2016. Littere d and un -managed plastic waste due to plastic packaging leads to environmental 
pollution in the country and hence needs to be managed. The reporting obligations of producers, 
importers and brand owners are given in Guidelines on Extended Producer Responsib ility for Plastic 
Packaging as given below. "The Producers, Importers & Brand -Owners shall file annual returns on 
the plastic packaging waste collected and processed towards fulfilling obligations under Extended 
Producer Responsibility with the Central Pol lution Control Board or concerned State Pollution Control 
Board or Pollution Control Committee as per pro forma prescribed by Central Pollution Control Board 
 
79 For previous statements follow the thread under ID 742 . 
80 For previous statements follow the thread under ID 719 . G/TBT/M/89  
 
- 108 - 
 
  by 30 June of the next financial year. Information on the reuse and/or recycled content used for 
packaging purposes will also be provided. The details of the registered recyclers from whom the 
recycled plastic has been procured will also be provided ".  
2.469.   The reporting needs to be done in the centralized online portal of plastic packaging.81 The 
guideline s for environmental compensation for non -fulfilment in EPR obligation has been notified by 
CPCB and is available on the website of CPCB.82 A separate module has been made operational on 
the centralized online EPR portal on plastic packaging for exchange of  EPR certification.83 The EPR 
guidelines recognize the following from plastic packaging category. (i) Category I: Rigid plastic 
packaging; (ii) Category II: Flexible plastic packaging of single layer or multi -layer (more than one 
layer with different types  of plastic), plastic sheets or like and covers made of plastic sheet, carry 
bags, plastic sachet or pouches; (iii) Category III: Multilayered plastic packaging (at least one layer 
of plastic and at least one layer of material other than plastic); (iv) Cat egory IV: Plastic sheet or like 
used for packaging as well as carry bags made of compostable plastics. Blister packs and shrink 
wraps wherever used as plastic packaging, are covered under category flexible plastic packaging.  
2.1.3.50   China - Key Points and Judgment  Principles of GMP Inspection for Cosmetics; 
Safety and Technical Standards for Cosmetics (2022); Technical Guidelines for Children's 
Cosmetics, G/TBT/N/CHN/1673 ; G/TBT/N/CHN/1674 ; G/TBT/N/CHN/1682 ; 
G/TBT/N/CHN/1699  (ID 74984) 
2.470.   The representative of the United States  provided the following statement. We previously 
made our concerns on this STC known during the November TBT Committee. While our concerns 
remain, because  many of the concerns with this STC also apply to our longstanding STC on China's 
CSAR measures, raised under STC#49, ID 57685, we will raise our concerns under that STC going 
forward.  
2.471.   In response, the representative of China  provided the following stateme nt. The Inspection 
Key Points and Judgment Principles of the Cosmetic Production Quality Management Standard are 
formulated for the purpose of regulating the cosmetic production licence, supervision and inspection, 
and guiding the cosmetic registrants, arc hivists and entrusted production enterprises to implement 
the "Cosmetic Production Quality Management Standard". There are no new obligations for the 
cosmetic registrants, archivists and entrusted production enterprises. As for the retention samples 
of imp orted cosmetics, according to the Measures for the Supervision and Administration of 
Cosmetics Production and Operation and the Announcement of the State Food and Drug 
Administration on Matters related to the Implementation of the Measures for the Supervis ion and 
Administration of Cosmetics Production and Operation, overseas cosmetics registrants and 
registrants shall retain samples of each batch of products imported to China after 1 January 2022. 
The samples and records shall be kept by the responsible per son within China. If the same batch of 
products is imported from China more than once, the sample shall be retained at least once at the 
time of the first importation.  
2.472.   The "Technical Code for Cosmetic Safety" sets forth the general requirements for cosmeti cs, 
the forbidden and permitted raw materials, and the safety and technical requirements for inspection 
and evaluation methods. In the process of revising the Code, full consideration has been given to 
various cosmetics regulations, standards and technical  requirements, including those of the 
International Organization for Standardization (ISO). The Technical Code for Cosmetic Safety was 
released for public comment in March 2022. In order to strengthen the technical guidance for the 
research and development  of children's cosmetics products, standardize and guide the registration 
and archival work of children's cosmetics, we have organized and formed the Technical Guidelines 
for Children's Cosmetics according to the Regulations on the Supervision and Administ ration of 
Cosmetics, the Measures on the Registration and Archival Administration of Cosmetics, the 
Regulations on the Supervision and Administration of Children's Cosmetics and other relevant legal 
documents, and solicited public opinions. In the drafting  process, we always adhere to the principle 
of "openness, transparency and extensive participation", refer to relevant technical guidelines at 
 
81 https://eprplastic.cpcb.gov.in/#/plastic/home  
82 https://cpcb.nic.in/uploads/plasticwaste/PWM -Amendment -Rules-2022.pdf  
83 https://eprplastic.cpcb.gov.in/#/plastic/home  
84 For previous statements follow the thread under ID 749 . 
85 China - Cosmetics Supervision and Administration Regulation and Regulation for Notification of Non -
special Cosmetics  (ID 576 ). G/TBT/M/89  
 
- 109 - 
 
  home and abroad, solicit opinions from industry associations, and revise and improve. Based on the 
principle of i ncreasing operability and providing technical guidance for the product research and 
development of enterprises, the Guiding Principles integrate and clarify the requirements of the 
Regulations and supporting legal documents on children's cosmetics, but do not put forward new 
requirements.  
2.1.3.51   India - Amendment to notification on mandatory testing and certification of 
telecommunication systems (MTCTE) – Phase III & IV, G/TBT/N/IND/229  (ID 76086) 
2.473.   The representative of China  provided the following statemen t. Article 5 "Only test 
results/reports issued by labs accredited by ILAC signatories from none -border sharing countries will 
be accepted " does not conform with the WTO/TBT Agreement: Article 2.1 "Members shall ensure 
that in respect of technical regulatio ns, products imported from the territory of any Member shall be 
accorded treatment no less favourable than that accorded to like products of national origin and to 
like products originating in any other country."; Article 2.2 "Members shall ensure that tec hnical 
regulations are not prepared, adopted or applied with a view to or with the effect of creating 
unnecessary obstacles to international trade."; Article 5.1.2 "conformity assessment procedures are 
not prepared, adopted or applied with a view to or wit h the effect of creating unnecessary obstacles 
to international trade."; Article 6.1.1 " verified compliance, for instance through accreditation, with 
relevant guides or recommendations issued by international standardizing bodies shall be taken into 
accou nt as an indication of adequate technical competence; ". China proposes India amend article 5 
of "Amendment to Notification on Mandatory Testing and Certification of Telecommunication 
Systems (MTCTE) --Phase III&IV" to accept test results from all laborator ies approved by the 
International Organization for Laboratory Accreditation Cooperation (ILAC) signatories.  
2.474.   In response, the representative of India provided the following statement. We thank the 
delegation of China for their continued interest in this mea sure. The paragraph 5 of the Amendment 
notification to MTCTE Phase III & IV dated 31 January 2022, provides "Test reports / results issued 
by labs accredited by ILAC signatories from non -border sharing countries will only be accepted. " In 
this regard, it i s submitted that presently the test reports/results issued by labs accredited by ILAC 
signatories has been accepted only for "Technical Parameters " of the Essential Requirements (ERs) 
as a relaxation to the MTCTE Procedure. The said relaxation is reviewed from time to time and 
extension is given considering all the aspects including the availability of labs in India. As on date, 
the said relaxation is valid up to 30 June 2023. The above -mentioned interim provision in Para 5 of 
the referred MTCTE amendment n otification dated 31 January 2022 addresses the unavailability of 
labs in India. The interim provision in Para 5 of the MTCTE amendment notification dated 31 January 
2022 has been introduced to ensure that telecommunication equipment used in India does not  pose 
a threat to national security.  
2.475.   The MTCTE scheme mandates that equipment undergoes testing and certification to evaluate 
its ability to withstand cyber -attacks, prevent unauthorized access to data, and safeguard the 
integrity and confidentiality of co mmunications. Given the crucial role of the telecommunications 
sector in India's infrastructure and economy, any security breach could have significant 
consequences for national security and stability. Hence, the MTCTE scheme is aimed at safeguarding 
India's essential infrastructure and economy from potential cyber threats by ensuring that 
telecommunication equipment used in the country meets specific technical standards and security 
requirements, and does not endanger national security.  
2.1.3.52   United States - Energy conservation program: energy conservation standards for 
room air conditioners, G/TBT/N/USA/305/Rev.1  (ID 75587) 
2.476.   The representative of China  provided the following statement. We appreciate the efforts 
made by the United States in ener gy conservation and environmental protection. China still has 
concerns on the progress of the technical regulations, and we suggest the United States pay 
attention to our comments and give a reply. The concerns are as follows: 1. It is recommended that 
RAC products could be evaluated by using seasonal energy efficiency indicators. The energy 
efficiency indicators of household room air conditioners are mainly divided into single -point energy 
efficiency (such as EER, CEER) and seasonal energy efficiency (such  as APF, SEER), in which single -
point energy efficiency is used for evaluation in the early stage. With the development of technology, 
 
86 For previous statements follow the thread under ID 760 . 
87 For previous statements follow the thread under ID 755 . G/TBT/M/89  
 
- 110 - 
 
  it has gradually been found that seasonal energy efficiency can evaluate the comprehensive 
performance of products more a ccurately, and has been adopted by major countries/regions such 
as the European Union, Japan, South Korea, and Australia. At present, energy efficiency standards 
in many Members  are upgraded to seasonal energy efficiency for evaluation. The energy efficien cy 
upgrade proposal of RAC products in the United States still uses CEER indicators for product 
evaluation and only changes in energy efficiency values. It is recommended that RAC products could 
be evaluated by using seasonal energy efficiency indicators.  
2.477.   2. If the above proposal cannot be adopted, it is recommended that energy efficiency 
upgrade could unify the test methods of the two types of products. There are two CEER test methods 
for RAC products in US regulations for fixed speed products and variable  speed products, which 
cannot show the advantages and disadvantages of the two kinds of products in energy efficiency. 
Therefore it is suggested to unify the test methods with variable speed products.  
2.478.   In response, the representative of the United States  provided the following statement. The 
United States appreciates the comments submitted by China on 2 June 2022. When we last checked 
the measure was not yet final. The United States will take into consideration all comments received 
during the open comment p eriod and respond to each substantive comment in the next published 
rulemaking procedure on standards for room air conditioners.  
2.1.3.53   India - Flat Transparent Sheet Glass and Safety Glass (Quality Control) Order, 
G/TBT/N/IND/118 , G/TBT/N/IND/119  (ID 66988) 
2.479.   The representative of the Republic of Korea  provided the following statement. Korea respects 
India's efforts in introducing the Safety Glass Quality Control Order (QCO) for the health and safety 
of the Indian people. Korean  companies are also endeavouring to comply with the Indian regulation 
faithfully. The implementation date of the Safety Glass QCO had been suspended to 1 April 2022 in 
February 2021, and again to 1 April 2023 in February 2022 due to COVID -19. And yet, Kore a 
understands that it is still difficult for the BIS certification body in carrying out its normal work. 
Korea would like to express its gratitude to India for suspending the QCO in consideration of the 
concerns raised by Korean exporters. However, althoug h Korean companies completed applications 
for certification in 2020, the following certification process, such as on -site factory inspection, is not 
being carried out after document review and continues to be delayed. As the QCO's entry into force 
is immin ent, companies that did not get factory inspection would be halted from exporting their 
products to India. Therefore, considering the situation of delays in the certification process due to 
the inspection bottlenecks caused by COVID -19, Korea would like to  request that either the 
enforcement of the Safety Glass QCO be postponed for at least six months or appropriate alternatives 
such as suspension of factory inspection be provided.  
2.480.   In response, the representative of India provided the following statement. W e thank the 
delegation of Korea for their interest in this issue. The Safety Glass (Quality Control) Order 2020 
was notified by the authorities on 12 March 2020 with date of implementation as 16 September 
2020. The date of implementation has been extended three times so far (i) it was first extended to 
1 April 2021 vide notification dated 23 June 2020 and (ii) then to 1 April 2022 vide notification dated 
25 February 2021 and (iii) to 1 April 2023 vide notification dated 10 February 2022. This shows that 
India has provided sufficient time as well as opportunity to the manufacturers from foreign as well 
as domestic entity in order to enable them to cope up with the mandatory Indian standards. The 
Bureau of Indian Standards (BIS) is carrying out physical inspec tions for applications received from 
foreign manufacturers, where the country to be visited is facilitating the visit of fully vaccinated BIS 
officers who are carrying negative RT -PCR test report, without the requirement of quarantine. With 
respect to appl ications received from Korea, visits are being planned wherever necessary formalities 
such as payment of application charge, scrutiny of application etc., have been completed.  
2.1.3.54   Australia - Maturation requirements for imported alcohol (ID 63689) 
2.481.   The represen tative 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 engagement 
in bilateral talks. In past meetings, we have shared our concerns with Australian technical 
 
88 For previous statements follow the thread under ID 669 . 
89 For previous statements follow the thread under ID 636 . G/TBT/M/89  
 
- 111 - 
 
  requirements applicable to cachaça, the Australian Customs Notice Nº 2007/19, which requires that 
some alcoholic beverages must be matured in  wood for a minimum of two years before delivery 
from Customs control. This covers all beverages under tariff classifications 2208.20.10, 2208.30.00 
and 2208.40.00. Even though said Notice only refers directly to brandy, rum, and whisky, it 
encompasses tar iff 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 matured for at 
least two years in wood. Such a requirement does not relate to any quality standard or sanitary 
requirement applicable to cachaça.  
2.482.   Following a public consultation in late -2019, the Australian Border Force (ABF) further 
explored a potential avenue to amend the Customs Act 1901 (Customs Act) that would enable the 
legitimate importation of certain alcohol products into Australia whilst retaining the maturation 
requirements for brandy, whisky, and rum. According to a more recent publ ic 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 list of exempt products would include 
Cachaça, Pisco and Bourbon. Brazil acknowledges progress in the course of action proposed in the 
last public consultation. We support the creation of a list of exceptions to the rules set out today in 
section 105A, thus allowing certain cultural and geographical indications (i.e. Cachaça) that are not 
traditionally described as brandy, whiskey or rum to be imported into the Australian market.  
2.483.   In order to avoid any confusion in the Australian market or amon g Australian consumers, 
we support that none of the sugar -cane products imported to Australia (matured or unmatured) that 
are not specifically "rum" should be labelled or marked as "rum". We kindly urge Australia to clarify 
the following points, which coul d not be addressed in its previous statements: - Could Australia 
please confirm if this new regulation will also establish new labelling requirements for products other 
than rum, brandy and whisky? - Could Australia provide timeframes for the publication o f the final 
text? 
2.484.   In response, the representative of Australia  provided the following statement. We 
acknowledge Brazil's continuing interest in Australia's review of maturation requirements for certain 
imported alcohol products. We also thank Brazil for th eir proactive engagement with Australia on 
this topic. Australia established a whole -of-government working group in 2022 to consider trading 
partners' concerns regarding the maturation requirements for the importation of certain alcohol 
products into Austr alia, and the domestic maturation requirements of brandy, whisky and rum. The 
working group is considering the legislative framework for the importation of certain unmatured 
alcohol products under section 105A of the Customs Act 1901 (Customs Act). In 2023 , the group 
will continue to work through the legislative complexities and stakeholder concerns associated with 
this matter to progress a way forward. The Australian Government will notify the Committee of any 
proposed legislative changes to section 105A o f the Customs Act and any other changes to alcohol 
import requirements, in accordance with Australia's obligation under the TBT Agreement.  
2.1.3.55   European Union - Withdrawal of the approval of the active substance alpha -
cypermethrin, G/TBT/N/EU/770 , G/TBT/N/EU/908  (ID 69490) 
2.485.   The representative of Kenya  provided the following statement. Kenya echoes her previous 
statement on this STC where EU has proposed new regulations withdrawing the approval of the 
active substance alpha -cypermethrin. Kenya raised t his as a Specific Trade Concern in the previous 
TBT Committee meeting and continues to have concerns over the same issue. Kenya uses this 
product in plant protection, animal health as well as public health management. The proposed 
technical regulation will  hurt Kenya which uses alpha -cypermethrin in the management of plant pest, 
vectors of animal and public health importance. This measure, therefore, will undermine Kenya's 
pursuit of legitimate objectives that is the protection of human health from tropical  diseases as well 
as ensuring food security. These products, when properly used, have not had any proven negative 
effects on humans. The EU measure therefore raises serious concerns of inconsistency with the TBT 
Agreement Article 2.2. The EU does not have sufficient scientific justification for it, and therefore 
needs to provide scientific justification for the measure. In light of the above the proposed measure 
would be deemed to be in contravention of Article 12.3 of the TBT Agreement which requires that 
"Members shall, in the preparation and application of technical regulations, standards and conformity 
 
90 For previous statements follow the thread under ID 694 . G/TBT/M/89  
 
- 112 - 
 
  assessment procedures, take account of the special development, financial and trade needs of 
developing country Members, with a view to ensuring that such  technical regulations, standards and 
conformity assessment procedures do not create unnecessary obstacles to exports from developing 
country Members ". Kenya requests the European Union to consider the withdrawal of the Regulation 
as the measure is more tr ade restrictive than necessary.  
2.486.   The representative of Brazil  provided the following statement. Brazil would like to express 
its concerns related to European notification G/TBT/N/EU/770  regarding the Commission 
Implementing Regulation proposal to withd raw 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 othe r products exported to the European Union. Withdrawal of the register of said substance 
and automatic reduction of MRLs will 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 more than USD 1.1 billion in 2022.  
2.487.   Alpha -cypermethrin is also an important component to conduct integrated pest 
management, once it may be combined with other insecticides to contribute to increase their useful 
life, ensuring efficient pest control and maintaining the sustainability of crop production. In light of 
the above, Brazil would like to kindly encourage the EU to adopt MRLs for imported products in 
accordance with t he limits set under the Codex Alimentarius. Brazil regrets that the EU did not 
extend the approval of the active substance, which expired on 31 October. Such measure would 
have minimized the impact on Brazilian citrus producers. At the same time, European countries still 
approve "emergency use " of the same substance, therefore discriminating against imported 
products.  
2.488.   The representative  of Paraguay  provided the following statement. Paraguay wishes to 
reiterate the importance of this substance in controlling pests that attack crops of great economic 
importance to the country, such as maize, soybean, sunflower and cotton.  In this regard, Paraguay 
once again requests the European Union to take into account, when reviewing the MRLs for this 
substance,  information on pesticides provided by the specialized agencies recognized by the WTO, 
such as the Codex Alimentarius, to reconsider its approach and to base its decisions on conclusive 
scientific evidence and real risk weightings, in accordance with inter national standards and 
principles.  
2.489.   In response, the representative of the European Union  provided the following statement. In 
principle the EU would like to refer to its previous statements at the TBT Committee, which we made 
on the issue of withdrawal of approval of this substance. As regards Maximum Residue Levels 
(MRLs), a review of the whole group of cypermethrins is currently conducted by the European Food 
Safety Authority (EFSA). Existing Codex Maximum Residue Limits and Import Tolerances will be 
considered in this review. 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 Members consider it necessary to ensu re 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 according to Articl e 6 of Regulation (EC) No 396/200591 on maximum residue 
levels of pesticides in or on food and feed of plant and animal origin.  
2.1.3.56   Colombia – Good manufacturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 69792) 
2.490.   The representat ive of the European Union  provided the following statement. The European 
Union would like to thank Colombia for its reply of November 2020 to the EU written comments and 
for the extensive bilateral discussions. The EU understands that Colombia is currently  in the process 
 
91 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, 16.3.2005, p. 1.  
92 For previous sta tements follow the thread under ID 697 . G/TBT/M/89  
 
- 113 - 
 
  of amending the relevant Decree to remove the GMP certification requirement and welcomes this 
development. In this respect, the EU would be thankful for a confirmation of this understanding and 
for any further information on this process, n otably on the envisaged timeline and content of 
amendments. In the meantime, until the new Decree comes into force, the EU wishes to reiterate 
our request to Colombia to accept all EU Free Sales Certificates for the purpose of certifying 
compliance with Go od Manufacturing Practices. The European Union continues to closely follow the 
situation and invites Colombia to notify to the TBT Committee any further amendments to the 
Decree. The EU would like to thank again Colombia for their cooperation in this matte r. 
2.491.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the draft Decree of the Ministry of Health and Social Welfare, partially amending Decree 
1686 of 2012, notified by the Government of Colombia to the Member s of this Committee on 
13 July 2022 through document G/TBT/N/COL/242 . The delegation of Mexico requests Colombia to 
indicate the latest status of the measure, and we kindly request confirmation regarding the 
elimination of the good manufacturing pra ctices certification requirement.  The delegation of Mexico 
thanks the delegation of Colombia for giving its consideration to these requests.  
2.492.   In response, the representative of Colombia  provided the following statement. First, we 
would like to thank delegat ions for the comments made with a view to better understanding of the 
measure.  Second, Colombia also notes the work being carried out by the Colombian health 
authorities and the countries concerned, with a view to clarifying the concerns raised regarding 
compliance with this measure.  In this connection, it is of the utmost importance to continue this 
process of working together, particularly with regard to certificates of good manufacturing practices 
for alcoholic beverages for human consumption.  Similarly,  progress has been made with internal 
working sessions between our authorities to assess the possibility of making adjustments to the 
provisions, with the aim of finding a mechanism for facilitating or relaxing the requirements.  This is, 
of course, without  prejudice to compliance with the provisions that not only guarantee sanitary 
conditions for the manufacture of alcoholic beverages but also safeguard human health.  It should 
be noted that such modifications should uphold the rules in force concerning the preparation, 
modification and issuance of technical regulations, which is why the regulator is conducting the 
respective regulatory impact analysis.  In conclusion, we reiterate our readiness to continue with the 
cooperation work ahead and to resolve this m atter.   
2.1.3.57   Belgium - Draft law introducing additional security measures for the provision 
of mobile 5G services, G/TBT/N/BEL/44 , G/TBT/N/BEL/45 , G/TBT/N/BEL /47 (ID 71393) 
2.493.   The representative of China  provided the following statement. China reiterates its concerns 
that the risk assessment criteria in notification G/TBT/N/BEL/44  lack a neutral and objective 
technical bas is. China hopes that  international technical standards that can objectively assess 
product security or use certification methods that are based on international standards are used in 
the decree as the sole or fundamental risk assessment criteria for produc t or service security. For 
G/TBT/N/BEL/47 , we would like to raise the following concerns: 1. China's core concern is that the 
notified decree shall adopt an objectively definable security standard based on product 
characteristics. In other words, the  assessment criteria with respect to the security of a product 
containing 5G technology shall focus on the characteristics of the products, or use certification 
methods that are based on international standards as fundamental risk assessment criteria for 
product or service security. Whether or not it originates from the NIS Cooperation Group's 5G toolbox 
is irrelevant. China considers that the risk assessment criteria of notified decree which neither relates 
to the 5G product characteristics nor contains th e objectively definable standard, is not consistent 
with the requirements of technical regulation under the TBT Agreement.  
2.494.   2. The decree has adopted the criteria in notification G/TBT/N/BEL/44  with respect to the 
extent of interference to the vendor b y a non -EU country. We consider that such criteria are based 
on the origin of vendors and discriminate the vendors from non -EU countries. Such criteria are 
neither objective nor impartial. China urges that Belgium should comply with Articles 2.1 and 2.2 of  
the TBT Agreement by applying objective, fair, and non -discriminatory 5G equipment security 
standards and measures, that is, taking full consideration of the characteristics and usage of 5G 
technology and adopting industry -recognized good practices. 3. We  would like to reiterate that the 
decree shall provide the so -called high -risk vendors (the "HRVs ") with complete, independent 
administrative or judicial remedies. In this regard, it is necessary to clarify the specific procedures 
 
93 For previous statements follow the thread under ID 713 . G/TBT/M/89  
 
- 114 - 
 
  to remove the HRV designa tion and their rights or seek relief. On the one hand, under the current 
provisions of the notified decree, the vendors of 5G equipment or services can only present and 
defend themselves through network operators when submitting the request for prior autho rization 
or when challenging the preliminary adverse decisions. If, for instance, the network operators do 
not request a hearing to the ministers concerned, the vendors of 5G equipment or services are 
deprived of any opportunity to request the ministers co ncerned to provide the rationales or evidence 
for their designation and to defend against the preliminary adverse risk assessment results. On the 
other hand, an HRV cannot get an effective remedy if it is merely allowed to submit an appeal against 
the desi gnation. The so -called HRVs are hindered from effectively seeking remedies provided to 
them under other Belgium laws and regulations when they are not fully informed of the reasons for 
the designation. The appeal against its designation decision is unlikel y to meet the practical necessity 
of 5G equipment or services vendors, taking into account the cost and duration of administrative 
litigation.  
2.495.   4. The decree generally prohibits the use of any active elements produced by HRVs in specific 
types of networks, and does not specify the classification of such 5G equipment or its parts according 
to their different security levels based on different security and risks of products. China considers 
that different security levels can be applied on the basis of product characteristics and objectively 
definable product security assessment standards in order to achieve the requirements of 
proportionality and necessity. In this regard, China suggests that Belgium could adopt differentiated 
management for 5G equipment or its  parts at different security levels on the basis of their product 
security and actual risks. With reference to the good practice of the industry, please apply 
appropriate and necessary technical measures to address the risk of them.  
2.496.   In response, the representative of the European Union  provided the following statement. We 
thank China for its continued interest in this measure. We would like to refer to our previous 
statements on this matter and the written feedback provided to China i n reaction to their written 
comments.  
2.1.3.58   Brazil - MAPA Ordinance No. 208, 26 February 2021 – revision of the Decree No. 
6.87 of 4 June 2009 on the standardisation, classification, registration, inspection, 
production and supervision of alcoholic beverages, G/TBT/N/BRA/1145 , 
G/TBT/N/BRA/1145/Add.1 , G/SPS/N/BRA/2033  (ID 71294) 
2.497.   The representative of the European Union  provided the following statement. The European 
Union would like to thank Brazil for submitting notifications G/TBT/N/BRA/1145/Add.1  and 
G/SPS/N/BRA/2033  published on 19 and 20 April 2022 and for the opportunity to comment on the 
draft texts. The European Union provided written comments to this notification on 13 July 2022 and 
would be grateful if it could receive a reply to them. In particular, the Eur opean Union asked whether 
imported beverages would fall under the registration requirement or whether they will benefit from 
a possible exemption. Furthermore, the European Union suggested, in line with international 
practices, the use of terms such as "alcohol ", "alc", instead of expression "alcoholic strength" or 
"alcohol content ". The EU also asked Brazil to provide justification for setting a maximum limit on 
the alcohol content of spirits, which may not be in line with international practices. The EU t herefore 
asks that Brazil remove the maximum alcohol content in all corresponding articles on spirits, in line 
with international practice. The European Union also asked for a number of clarifications concerning 
spirits categories definitions in notified d raft such as liqueur, rum, whiskey, vodka, gin and aquavit, 
and made specific proposals to better align those definitions with international practice and avoid 
the risk of causing unnecessary obstacles to trade. The European Union would be grateful if the 
above -mentioned comments could be taken into account and replied to before adoption of the 
notified draft.  
2.498.   The representative of Mexico  provided the following statement. The Government of Mexico 
refers to the draft Regulation on Law No.  8.918 of 14  July 1994 (Beverages Law), notified by the 
Government of Brazil to the Members of this Committee on 19  April 2022 in document 
G/TBT/N/BRA/1145/Add.1 . The Government of Mexico thanks the Government of Brazil for its 
compliance with the transp arency commitments and the possibility granted for the issuance of 
comments on this Regulation, which were submitted by Mexico in July  2022 during the public 
consultation period and were kindly addressed by the Government of Brazil in August  2022.  The 
comm unication from the Government of Brazil indicated that responses would be provided to the 
 
94 For previous statements follow the thread under ID 712 . G/TBT/M/89  
 
- 115 - 
 
  comments received during the consultation period and would be published on the relevant Ministry's 
website. In addition, Brazil also indicated that it would publish a  new draft of the Regulation that 
would consider the comments suggested through the WTO E -Ping Platform prior to its entry into 
force.  In this regard, the delegation of Mexico requests the delegation of Brazil to provide information 
on the entry into force  and the status of this Regulation today.  The delegation of Mexico thanks the 
delegation of Brazil for giving its consideration to this statement and the requests made therein.  
2.499.   In response, the representative of Brazil  provided the following statement. Bra zil would like 
to thank the EU and Mexico for their statements and for the comments they submitted in reply to 
notification G/TBT/N/BRA/1145/Add.1 . We also welcome the contributions from other countries to 
our public consultation. Brazilian authorities are currently reviewing all of them and we would like to 
assure that they will be duly considered. Proposed amendm ents to Decree Nº 6,871/2009 aim to 
simplify the definitions of alcoholic beverages and their standards of identity and quality. The draft 
also introduces improvements in the control and registration systems and administrative measures 
based on risk analys is, in order to reduce the administrative burden for companies and to ensure 
supply of products with lower risk. In the next steps of this regulatory process, we will publish our 
answers to the comments and a revised draft regulation of law No. 8,918, of 1 4 July 1994 (Beverage 
Law). This revised draft will be notified to all Members and further comments will be accepted. We 
appreciate engagement from our trade partners and assure them that the development of this 
regulation will remain transparent and align ed to our WTO commitments.  
2.1.3.59   Morocco - Conformity assessment, G/TBT/N/MAR/28  (ID 77995) 
2.500.   The representative of the European Union  provided the following statement. On 
18 December 2019 Morocco notified to the WTO TBT Committee the verification of conformi ty of 
certain imported industrial goods under reference G/TBT/N/MAR/28 . The EU sent comments in 
January 2020 and also followed up with bilateral discussions and two letters. Despite these 
discussions concerns remain on the EU side. As regards the conf ormity control system for industrial 
products, Morocco informed us that the legislative framework does not make a distinction on the 
basis of whether the product is imported or manufactured locally. However, it appears that the 
arrangements for checking co mpliance vary depending on whether imported or local products are 
concerned. Since the introduction of the new system in February 2020, checks on imported industrial 
products have been outsourced and appear to require the systematic obtaining of a certific ate of 
conformity issued by one of the approved bodies, which is very burdensome and costly. On the other 
hand, checks on local products are carried out on the basis of a national market surveillance plan, 
and risk -based according to the products in questi on, so not on a systematic basis. This difference 
in treatment seems problematic to us.  
2.501.   The TBT Agreement (Article 5.1.1) provides that conformity assessment procedures should 
be prepared, adopted and applied so as to grant access to suppliers of like prod ucts originating in 
other Members under conditions no less favourable than those accorded to suppliers of like products 
of national origin, in a comparable situation. For some products these checks are done at origin, for 
some others in Morocco upon arriva l. Could Morocco please explain the rational between the choice 
for putting a product under one or the other procedure? The Moroccan conformity assessment 
procedure for the respective products create an unnecessary obstacle to international trade as the 
procedures seem more strict than necessary to give Morocco adequate confidence that products 
conform with the requirements set out in technical regulations. In this respect some aspects of the 
procedures need to be clarified, like whether there is any possib ility for importers to avoid repeating 
the conformity assessment procedure for any shipment to Morocco, which seems to be unnecessarily 
burdensome in particular for less risky products.  
2.502.   Moreover, for Morocco's technical regulations that impose the use of M oroccan standards 
corresponding to international and EU standards, Morocco should accept EU certificates that are 
based on the same international and EU standards and done by ILAC laboratories like a lot of 
countries are doing world -wide. Another important  problem that we face is that some Moroccan 
regulations depart from international standards without providing an adequate justification for it. 
The standardiZation process and the subsequent transformation of the national standards into 
compulsory technica l regulations also raises questions of transparency. We would be grateful if 
Morocco could take these concerns into account and work on the review of their conformity 
 
95 For previous statements follow the thread  under ID 779 . G/TBT/M/89  
 
- 116 - 
 
  assessment system. We are ready to engage further in bilateral discussions in order to cl arify the 
issue further.  
2.503.   The representative of Morocco  did not provide a response to the concerns raised.  
2.1.3.60   Angola - Decreto Executivo n°186/22 by the Ministerio das Finanças (ID 77696) 
2.504.   The representative of the European Union  provided the following stateme nt. On 10 March 
2022, Angola published the Executive Decree n°149/22 introducing the obligation to affix High 
Security Tax Stamps on certain products including beverages (beer, wine, spirits, soft drinks) and 
tobacco in order to fight smuggling. This decre e was supposed to enter into force on 10 April 2022. 
On 8 April 2022, the Angolan authorities published the Executive Decree n°186/22, which suspended 
the mandatory affixing of high -security tax stamps on all alcoholic beverages. There is so far no 
revised  decree, but the entry into force seems to be still foreseen for April 2023. Angola has not yet 
notified this draft measure to the TBT Committee and we request Angola to notify as soon as 
possible, so that all Members can provide their comments on the draf t measure well ahead of the 
adoption and entry into force. As announced by Angola after the November 2022 TBT Committee a 
number of improvements to the system are foreseen that would address some of our concerns. For 
example, the ability to affix tax stamp s in Angola and the foreseen transitional period of six months 
after publication and entry into force of the Regulation on Compulsory Sealing, – although a one -
year transition period would be better. However there is so far no new decree that could confirm  
these announcements.  
2.505.   A number of concerns still remain: - Need for further guidance on the new system - A stock 
exhaustion clause. Angola's proposal that tax stamps should be affixed on products in stock which 
are not sold after the transitional period do es not amount to a stock exhaustion clause. We recall 
that it is very important to notify any new draft decree to the WTO TBT Committee well in advance 
and to consult with all relevant stakeholders and take their comments into account. In any case the 
currently announced transition period of six months is insufficient and should be at least one year. 
Furthermore a stock exhausting clause should be foreseen and operators need more guidance. 
Different announcements were made in the course of the last year and  it would be important to 
confirm these through a new decree in order to offer legal certainty. We would be grateful if Angola 
could take these concerns into account. We are ready to engage in bilateral discussions in order to 
clarify the issue further.  
2.506.   In response, the representative of Angola  provided the following statement. In response to 
EU Statement, we would like to consider in part as valid, our declaration made at the last TBT 
meeting, held on 16 November 2022.  However, we add that, the decree and the regulation have not 
yet been submitted for consideration by WTO Members, because some changes are being made, 
based on the proposals received of stakeholders, especially regarding on the price of digital tax 
stamps and we believe that the situation wil l be resolved soon. We sincerely apologize, however, we 
remain committed to notify the measure, as soon as its respective proposal is finalized. Finally, we 
inform the EU, that our institution is preparing to hold bilateral meetings in Luanda or in Brussel s.  
2.1.3.61   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 73397) 
2.507.   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 in December 2021. The EU sent written comments on 16 February 2022. 
The EU – through a letter sent on 21 October 2022 by the Ambassador to South Africa - also on 
behalf of several EU member States' Ambassadors to South Africa - to the Director General of the 
Department of Agriculture, Land Ref orm and Rural Development – also requested clarifications and 
raised concerns with specific aspects of these regulations. This was furthermore supported by a 
letter of the Italian Ambassador to South Africa's Minister Didiza sent on 25 October 2022. Our ke y 
concerns relate to the following South African categories: spirit aperitif, gin, description of pot still 
brandy and vintage brandy. The amended regulation related to the composition, production and 
labelling of wine and spirits intended for sale in the Republic of South Africa was published on 15  July 
 
96 For previous statements follow the thread under ID 776 . 
97 For previous statements follow the thread under ID 733 . G/TBT/M/89  
 
- 117 - 
 
  2022. Many of the amendments under the new regulations will enter into force in December 2025 
for products already approved on the South African market, but seem to apply already for products 
not yet approv ed prior to 15 July 2022.  
2.508.   South Africa has already started to block products not yet approved by South African 
Authorities which do not meet the criteria set in the new rules. This does not apply to products that 
had received an approval from South Africa prior to publication of the new rules in the Gazette, as 
we understand, as many of the new rules will only apply to them in December 2025, but is still 
concerning and impacts a number of EU products. While some of our concerns concerning the new 
spirit ape ritif category have been taken on board (including safeguards on how the name of the spirit 
used for production of this drink can be used and displayed on the label and comments in relation 
to gin), there are some important issues with the new rules which result in products being excluded 
from the South African market. While local producers will be able to reformulate in line with the new 
rules, EU producers will not, for economic reasons. The category of "spirit aperitif" with its minimum 
and maximum alcoh olic strength together with the existing minimum alcohol limits set for other 
"defined classes" in South Africa (example whiskey) could result in a number of EU spirit drinks no 
longer having the right to be marketed in South Africa. We suggested that Sout h Africa creates a 
new category "spirit drink" for products that do not fall under South African categories due to their 
alcohol content. Without the flexibility that a "spirits drink " category could offer, many EU products 
will no longer be exportable to South Africa.  
2.509.   Moreover, the European Union would like to continue the discussion on aligning the minimum 
maturation period with the one set in Cognac product specifications as well as some of the analytical 
parameters set by the 1989 Act regarding the bran dy class. We would be grateful if South Africa 
could take these concerns into account as a matter of urgency, given the blockages of products. 
Reformulating is not an option for imported spirits, and the rules should therefore be adapted to 
allow EU spirit s to be sold in South Africa.  
2.510.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to its statement at the previous meeting of this Committee in November  2022, in which a 
specific trade concern was presented once a gain regarding the Regulations relating to the 
composition, production and labelling of wine and spirits intended for sale in the Republic of South 
Africa, notified to the Members of this Committee on 20  December  2021 in document 
G/TBT/N/ZAF/48/Rev.2/Add.1 . In this regard, we would like to reiterate the main concerns referred 
to in that statement and in the comments sent by the Government of Mexico during the public 
consultation period for the measure, as well as through a bilat eral meeting held with the competent 
authorities in South Africa in October last year:  The definition and requirements set out in Annex D 
of the Regulations for the "100% agave" category are in line with the "100% -agave tequila" category 
provided for in Me xican Official Standard (NOM) 006 concerning tequila. In light of the above, a 
possibly deceptive practice would arise from the mistaken perception of consumers that when 
purchasing a spirit under the name "100% agave" they would be acquiring a tequila in the "100% 
agave" category or another beverage of Mexican origin made 100% from agave.  
2.511.   Moreover, five out of the seven classes envisaged for the "100% agave" category in the 
South  African Regulations replicate the five classes of tequila referred to in the NOM concerning 
tequila.  In this regard, Mexico has repeatedly requested that there be a specific class for tequila and 
that the "100% agave" class in the Regulations should not refer to tequila or the categories thereof.  
Furthermore, the WTO's TBT Agreemen t recognizes the prevention of deceptive practices as a 
legitimate objective of technical regulations, so that the use of language that was undoubtedly drawn 
from Mexican standards in the Regulations, on top of the refusal of the South African Government 
to provide an alternative for the differentiation of tequila, could be considered as a technical barrier 
to trade for Mexico.  For this reason, we once again urge the South African Government to reconsider 
the concerns and comments voiced by Mexico.  We also reiterate our request for a bilateral follow -up 
meeting in order to reach a mutually satisfactory solution.  
2.512.   In response, the representative of South Africa  provided the following statement. South 
Africa would like to thank European Union (EU) and Mexico fo r continued interest on the regulation 
relating to the composition, production and labe lling of wine and spirits intended for sale in the 
Republic of South Africa. South Africa, in consultation with the affected industry, has been discussing 
proposals and notified unintended consequences of the amendments in relation to the regulation at 
hand. Virtual meetings were held with Mexico to discuss and clarify the concerns raised. South Africa, 
under the Department of Agriculture, Land Reform and Rural Developmen t (DALRRD), is G/TBT/M/89  
 
- 118 - 
 
  reconsidering the regulation with the view to address notified unintended consequences of the 
regulation by WTO Members. On the same token, South Africa is undertaking activities to deal with 
section 12 of the South African regulation on mat ters related to spirit aperitifs being passed  off as 
spirits. The process is such that the draft amendments of the regulation shall follow the due 
Departmental approval processes and procedures that underpins gazetting the revised regulation 
for publicatio n and notification in order to solicit comments from all affected stakeholders. This 
process will include the notification to the WTO. Whilst this process is ongoing, there will be no 
impact on trade relating to the products imported as Spirit Aperitifs. I mporters and local producers 
of Spirit Aperitifs have been applying for concessions and may continue to apply for concessions to 
sell products under the prior Spirit Aperitif category until 31 December 2025. South Africa will 
provide regular updates.  
2.1.3.62   Mongo lia - Draft Law on controlling the circulation of alcohol beverages, and 
fight against alcoholism, G/TBT/N/MNG/14  (ID 73098) 
2.513.   The representative of the European Union  provided the following statement. The EU would 
like to raise its concerns about the implementation of this measure. We understand that the new 
law requires that imported products already need to have tax stickers affixed to them before they 
arrive at the Mongolian border and can no longer be affixed to the product in bonded warehouses in 
Mongolia, as was previously the case. There is a lack of detailed information about this new 
requirement, for instance, whether tax stickers must be sent from Mongolia or whether they will be 
printable/downloadable from a website. Given that the date of entry into force of this measure is 
1 July 2023, the EU requests that Mongolia provide clarity on these new obligations as soon as 
possible.  
2.514.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to its statement at the March  2022 meeting of this Committee, regarding the draft Law on 
controlling the circulation of alcoholic beverages and fighting against alcoholism, notified by the 
Government of Mongolia on 12  August  2021 to the Members of this Committee in document 
G/TBT/N/MNG/14 . In this regard, the delegation of Mexico reiterates the concerns that this measure 
causes in the Mexican industry producing alcoholic beverages.  The dele gation of Mexico also requests 
the Government of Mongolia to clarify the scope of these regulations, as well as their status and 
compliance with transparency obligations contained in the WTO's TBT Agreement.  
2.515.   In response, the representative of Mongolia  provided the following statement. Mongolia 
would like to thank delegations of the EU and Mexico for their statement. We take note of the 
questions raised by the delegation of the EU. We will refer your clarification to our competent 
authority in the capital an d revert in due course via your Enquiry Point. In regard of the concerns 
raised by the delegation of Mexico during the TBT Committee session in March 2022, we would like 
to inform that the provision on the prohibition of alcoholic beverages with alcohol co ntent of more 
than 35% was excluded during the hearings of the draft law. Also, the law has no provisions 
prohibiting sales through electronic channels. However, there is a provision prohibiting the sale, 
service and delivery of alcoholic beverages by pers ons and entities who do not have the appropriate 
licence, including in the online environment. The law was adopted in July 2022 and came into force 
on 1 January 2023. We are ready to engage with the delegation of Mexico to provide more 
clarification and ex planation if necessary.  
2.2  Exchange of Experiences   
2.2.1   Transparency  
2.2.1.1   Update on the Transparency Working Group Meeting  
2.516.   The Chair recalled that the transparency working group had been  established in March 2022 
to advance with the numerous Triennial Review recommend ations related to transparency. The third 
meeting of the working group had been  held on 6  February  (he noted that some key takeaways from 
the meeting are contained in ICN/TBT/14/Add.4 ). The Chair thanked delegations who  had come  
forward with proposals and comments.  During the meeting, Members considered a revised proposal 
from Canada ( JOB/TBT/485/Rev.1 ) regarding notification guidelines, which took into account 
 
98 For previous statements follow the thread under ID 730 . G/TBT/M/89  
 
- 119 - 
 
  feedback from Members, including written comments from U ganda in JOB/TBT/492 . Colombia's 
comments on the proposal had subsequently been circulated in JOB/TBT/496 .  
2.517.   The representative of Canada  thanked Colombia for sharing their comments on its proposal 
regarding modifying  the notification  guidelines. Canada had reached out to the Colombian mission 
in Geneva to discuss Colombia's comments , and the Colombian mission , Canada understood, was  
currently in consultations with capita l-based experts . Canada would, as necessary,  circulate a 
revised version of its proposal before the next working group meeting.  
2.518.   The representative of Singapore  express ed his delegation 's support for Canada's revised 
proposal on notifications guidelines which sought  to improve the quality of notific ations and to put 
all Members on a level playing field regardless of the language of the notifications . Singapore  
believed that some of the proposed additions to the guidelines could be useful in providing further 
clarity and predictability for exporters, companies , and other relevant stakeholders. Singapore  was 
reviewing the proposed amendments to the notification  guidelines and would  provide comments in 
due course.  
2.519.   The Chair drew the Committee 's attention to  another proposal , this one from the United 
States: a draft template to assist Members in preparing Article 15.2 notifications through ePing , 
subsequently circulated in JOB/TBT/495 . The United States  had also clarified that they had 
withdrawn  their previous proposal related to Article 15.2, contained in JOB/TBT/466 .  
2.520.   The representative of the United States  recalled that d uring the 6 February meeting of the 
Working Group on Transparency, the United States had shared a proposal for possible field s to 
include in the Article 15.2 notifications section of the notification submission interface  in e-Ping 
(JOB/TBT/495 , 10 February 2023 ). The Article 15.2 notification template in ePing contain ed open 
text space  – it did not have fields for the Member to s tructure the input , as available for submitting  
regular and addenda notifications under  Articles  2.9.2, 2.10.1, 5.6.2, 5.7.1, 3.2, 7.2 , or other.  The 
fields suggested for 15.2 notifications in the U.S. proposal came  directly from Article 15.2 of the TBT 
Agreement and G/TBT/1/Rev.15  (Section 6.2.1 ).  Providing fields and prompts in the ePing 
submission interface on what information to include in  a 15.2 notification could be helpful in guiding 
Members that ha d not submitted their 15.2 statements while also encouraging other Members to 
update elements of their 15.2 notifications where needed. This would improve transparency for all 
Members.  Given c urrent efforts to improve and enhance ePing, JOB/TBT/495  was a concept for the 
Secretariat to consider in order to provide more structure to the notification format for the 
submission of notifications by Members under Article 15.2, subject to current techno logy limitations. 
The United States remain ed willing to collaborate with the Secretariat and other  Members of the 
Committee 's Transparency Working Group to support the implementation of transparency 
recommendations and simplify the submission of new or upd ated notifications under Article 15.2 of 
the Agreement.  
2.521.   The Chair recalled that the working group ha d also asked the Secretariat to prepare a 
compilation document of all current notification templates and guidelines so as to facilitate the 
working group's review in light of the Ninth Triennial Review recommendations.  This document was 
in the pipeline. The Chair proposed that the next meeting of the working group take place in advance 
of the Committee's June meetings  (date subsequently confirmed as 11 May ). 
2.2.1.2   Planning of the Tenth Special Session on Procedures for Information Exchange  
2.522.   The Chair recalled that the TBT Committee had decided,  in 1995, to hold regular meetings 
for persons responsible for information exchange, including those responsible for enquiry points and 
notifications. The 9th Special Meeting on Procedures for Information Exchange was held on 18 -
19 June 2019, and its meeting report can be found in G/TBT/GEN/265 . He noted that at the 
Committee 's November meeting (2022), he had proposed that the Committee hold its 10th Special 
Meeting on 19  June 2023 , and this was agreed.99  
2.523.   The Secretariat  recalled that  the Committee 's Special Meetings  on Information Exchange  
focused on implementing  transparency provisions and procedures. In practice, since 1995, nine such 
Special Meetings ha d been held – one every three years. Delegations could  access the reports of all 
 
99 G/TBT/M/88 , para. 2.476.  G/TBT/M/89  
 
- 120 - 
 
  these meetings through G/TBT/1/Rev.15 , para. 6.8.2.  The last Special Meeti ng, held in June 2019 , 
had been structured around transparency -related recommendations from the Eight h Triennial 
Review , which concluded in 2018 , including the functioning of Enquiry Points , tracking and reacting 
to notifications , handling of comments , establishing which measures should be notified under SPS 
and/or TBT Agreements , technical cooperation , and notification and availability of adopted final texts  
– which had led to the adoption of the revised format.  Following the June 2019 Special Meeting, the  
Committee also held two thematic sessions on transparency, in February 2021 and July 2022, 
covering specific transparency topics. In addition, the transparency working group, set up in March 
2022, provide d another avenue to discuss transparency practices.  For the upcoming Tenth Special 
Meeting, the Secretariat suggested that  delegations may wish to focus on some of the pending Ninth 
Triennial Review recommendations. For example, there could be further exchanges on commenting 
on notifications, improving pro duct coverage information in notifications , or updating notifications 
formats and guidelines. The Secretariat could also provide a more comprehensive presentation on 
the various functions of the new ePing Platform, followed by an exchange of experiences by  
Members.  
2.524.   The representative of the Russian Federation  noted that Article 10 of the TBT Agreement 
provides that Enquiry Points should be able to answer all reasonable enquiries  from other WTO 
Members and interested parties in other Members. In this context , it would be interesting to learn if 
there was legislation in place in WTO Members defining " interested parties " that were eligible  to 
submit enquiries  to the Enquiry Points , and also the practic e of different WTO Members of treat ing 
inquiries  from foreign interested parties . 
2.525.   The Chair encourage d delegations to make sure that their Enquiry Points and Notifications 
Authorities were able to participate actively at the Special Mee ting, preferably in -person and 
otherwise virtually.  
2.2.1.3   Update by Secretariat on ePing  
2.526.   The Secretariat  reported on an ePing walk -in session held on 8 March. She thanked 
delegations for their questions and feedback  which  helped the Secretariat in refining furt her the 
platform's services. She noted that ePing  currently has slightly more than 20,000 registered users, 
around half from governments and the rest from private companies, academia, NGOs , and IGOs 
(more information on Members  that have the highest number of subscribers and other developments 
related to  ePing is available in the Annual Review  document  G/TBT/50  in Section 3.5 ).  
2.2.2   Conformity Assessment Procedures  
2.527.   The Chair reported on this consultation  on the guidelines for conformity assessment 
procedures.  He recalled, first, that at the Eighth Triennial Review o f the TBT Agreement, the 
Committee had agreed to develop guidelines to support regulators in the choice and design of 
conformity assessment procedures. Subsequently, in the Ninth Triennial Review, the Committee had 
noted progress and agreed to finalize thi s work. To this end, the Chair said that he had been holding 
consultations.  A few points could be made:  
a. There is good engagement . To date, delegations had engaged  substantive ly in the 
process. So far in 2023, consultations  had been held in late January and  in early February , 
and they would continue through to the regular meeting  in June;  
b. Process . The Chair stressed that the process is an open one. Participation by all Members 
was welcome. Any Member wishing to participate in the consultations was welcome to do 
so. It was possible to do  this both in person and virtually. The relevant documents were 
kept up -to-date on a webpage for Members that was accessible through the TBT Gateway . 
In addition, the Chair noted that he regularly sent out communications that indicate dates 
and next steps.   
c. Status quo . The Secretariat had issued a revision of the draft guidelines on conformity 
assessment. This draft is contained in document JOB/TBT/438/Rev.2 , issued on 
9 February 2023.  The latest version of the draft is posted on the TBT Gateway under the 
workstream for conformi ty assessment.  G/TBT/M/89  
 
- 121 - 
 
  2.528.   The Chair noted, r egarding the latest document (Rev.2), that it showed the status of the 
draft guidelines following  his last consultation with Members , which had completed a full review of 
the text on a paragraph -by-paragraph basis. He stressed that the document remained a draft. There 
were a number of square brackets in the text where Members ha d discussed alternative textual 
drafting. He encouraged  delegations  to engage among themselves  to try to find convergence.  
2.529.   The United Kingdom  welcomed the progress that ha d been made and expressed an interest 
in other Members ' views , especially those that had  not yet had a chance to participate.  
2.2.3   Regulatory Cooperation Between  Members  
2.2.3.1   Report by the Moderator on the Thematic Session s  
2.530.   The Modera tor100 for the thematic session on Thematic session on regulatory cooperation 
between members on plastic regulation , held on 7 March 2023, provided his report. The full report 
is contained in G/TBT/GEN/ 351.   
2.531.   The Moderator101 for the thematic session on Thematic session on regulatory cooperation 
between members on climate change , held on 7 March 2023 , provided his report. The full report 
is contained in G/TBT/GEN/ 352.  
2.532.   The Chair said that the Committee took note of the moderators ' report s. He referred the 
Committee to the TBT Gateway , which would contain the full moderators ' report s and the 
presentations by all the speakers. He noted that the number of speakers had left very little time for 
debate and discussion and that the Committee needed to look into this.  
2.533.   The Secretariat  suggeste d discussing  how to use  the allocated three hours for each thematic 
session. Possible limitations, such as limiting the number of speakers or time to speak, could be 
considered to allow more time for discussion and debate. The Secretariat acknowledged that  it could 
be difficult to refuse a Member on the speakers' list, even if it was getting long. This could be 
discussed informally within the Committee.   
2.534.   The representative of the European Union  stated that the EU wanted to take the opportunity 
to share some  general comments on the thematic sessions. The EU had always been very committed 
to this exercise, but they wanted to convey some concerns regarding the  thematic session  on climate  
change . The objective of the thematic sessions was to share informally  the best practices and 
experiences among Members, with the aim of facilitating the work within the TBT Committee. 
However, the EU noted a last -minute change of the speaker from South Africa, which was not 
reflected in the agenda. This last -minute replacement of the delegation of South Africa, which 
represented the Business Association, did not provide the necessary transparency in the context of 
the presentation. The substance of the presentation was contrary to the purpose and the well -
established practice of  the thematic sessions, which is to share experiences and increase 
understanding  of Members' approaches. Finally, the EU had been very transparent with the European 
Green Deal measures in the WTO and bilaterally, even from the early drafting stages. While the 
majority of the European Green Deal measures did not fall under the scope of the TBT Agreement, 
and in particular those mentioned by some speakers on Tuesday, they would continue to engage 
with WTO Members in the TBT Committee as regards those measures  that were within the scope of 
the TBT Agreement. On a more practical aspect, in the future, it would be useful to be aware of the 
participants attending the online  thematic sessions . In the current format, it was not possible to 
identify who participated,  and therefore it was also difficult to provide a reply intended for everybody. 
The EU hoped that WTO Members could follow these good practices .  
2.535.   The representative of the United States  congratulated the Moderators for doing a good job 
managing the speaker s during the public session. The representative agreed with India's suggestion 
to appoint moderators early for the next meeting, as the role is important and requires time for 
planning. Regarding limits, the representative supported having fewer presentation slides and more 
dialogue, as many presentations can be redundant.  She suggested discussing limitations, such as 
the number of speakers, presentation length, number of slides, and questions asked, in an informal 
 
100 Mr. David Jankowski (United States).  
101 Mr. Aashis h Shandorkar  (India). G/TBT/M/89  
 
- 122 - 
 
  mode. The representative also me ntioned submitting some informal suggestions to the Secretariat 
from online participants, including prioritizing questions. The representative appreciated the honest 
technical dialogue and thoughtful presentations during the thematic sessions, which gave a  better 
understanding of compliance measures.  
2.536.   The representative of the United Kingdom  expressed their appreciation for the thematic 
sessions and praised the Moderators for managing the large content volume . They agreed that the 
Committee should work toget her to establish limits on time and speakers . She suggested  that 
managing the amount of time each speaker has would be beneficial for the interactive Questions 
and Answers section. They also supported the idea of agreeing on moderators early on, which woul d 
allow Members to contribute as speakers more effectively. The representative expressed their 
willingness to work informally to contribute ideas for further improvements.  
2.537.   The representative of Singapore  expressed appreciation for the Moderators and found the 
sessions insightful. Singapore agreed with earlier speakers  that there is room for improvement in 
organizing  thematic sessions . Nonetheless, Singapore suggested having flexibility with the 
imposition of limitations on time and speaker as Members may ha ve different levels of interest in 
different topics . The representative also agreed with their EU counterpart that more information 
about the speakers and presentations would be helpful in determining if and what limitations  are 
required . The representativ e also suggested  that the Committee could review the timeliness of its 
finalisation of the topic of thematic session with the aim of providing the Secretariat with adequate 
time for their effective organisation of thematic sessions . The representative  also agreed with the 
suggestion to have an informal discussion on improving thematic sessions before the June meeting.  
2.3  Other Matters  
2.3.1   Planning of the 2023 Thematic sessions  
2.538.   The Chair mentioned that the Members had agreed to have a thematic session on "regulato ry 
cooperation between Members" with three separate topics to be covered in the next meeting in June. 
The three topics were "digital products ", "cybersecurity" , and a third topic yet to be defined. 
Additionally, one related topic that could be discussed in  June was "current challenges and best 
practices for addressing issues related to the conformity assessment of goods obtained through e -
commerce ." This would mean the June thematic session could focus on the digital sphere. The 
Chairman also raised the que stion of whether to have three topics or to leave the third topic and 
have two sessions and whether to consider having one and a half days.  
2.539.   The representative of the United States  stated that the Committee had  already scheduled  a 
special meeting on information exchange on Monday 19 and thematic sessions on digital products 
and cybersecurity on Tuesday , 20 June. These topics were popular , and having a third topic would 
be difficult due to time constraints.  
2.540.   The representative of the European Union  agreed with this position, stating that it would be 
an intense week.  
2.541.   The representative of the United Kingdom  suggested having the session in the morning and 
extending it to one and a half days, as there was a lot of interest in engagin g more. They expressed 
a willingness to continue discussing possible solutions informally.  
2.542.   The Chair proposed to stick to the two topics for June. It was so agreed.  
 
2.3.2   Planning of the 10th Triennial Review  
2.543.   The Chair recalled that at the end of 2024, the Committee would  need to complete its Tenth 
Triennial Review. Article 15.4 of the TBT Agreement states:  
"Not later than the end of the third year from the date of entry into force of the WTO 
Agreement and at the end of each three -year period thereafter, the Committee shall review 
the operation and implementation of this Agreement, including the provisions relating to 
transparency, with a view to recommending an adjustment of the rights and obligations of G/TBT/M/89  
 
- 123 - 
 
  this Agreement where necessar y to ensure mutual economic advantage and balance of rights 
and obligations, without prejudice to the provisions of Article 12. Having regard, inter alia, 
to the experience gained in the implementation of the Agreement, the Committee shall, 
where appropria te, submit proposals for amendments to the text of this Agreement to the 
Council for Trade in Goods" . (TBT Agreement, Article 15.4)  
 
2.544.   The Chair noted that the last triennial review, the Ninth, was contained in document 
G/TBT/46  and was adopted in November 2021. The first organizational step in the triennial review 
process was to develop a timeline for the Committee 's work. Three years ago, the Committee had 
agreed  on such a timeline contained in G/TBT/W/735 . The Secretariat ha d prepared a draft timeline 
that was based on previous practice . He said this draft is  contained in document JOB/TBT/499 . The 
Chair drew Members ' attention to the draft and ask ed delegations to provide the Secretariat with 
any comments before  our June meeting . At that point,  the Committee would agree on the timeline.  
He set the deadline for comments to 15 May  2023, allowing  the Secretariat to make any changes 
needed ahead of June.  The Chair also suggested that the Secretariat hold a briefing on the Triennial 
Review process ahead of the November  2023 meeting to bring Members up to speed, particularly  
developing country delegations and those new to the TBT Committee.  
2.545.   The representative of Brazil  inform ed the Committee about the translation of the TBT 
handbook into Portuguese, which will be launched on 30 March. The National Enquiry Point, the 
National Confederation of the Industry in Brazil, and APEC Brazil, which is the export promotion 
agency, worked together  with the Secretariat to prepare the Portuguese version of the handbook. 
Brazil was of the view that it would be helpful to the Portuguese -speaking community worldwide, 
which amount ed to approximately 300 million people. A launch event would  occur  in Brasi lia on 
30 March at 10 a.m. (Brasilia time), and the Secretariat would  share the details with the TBT mailing 
list so that any member or stakeholder could  participate in the event online.  
3  TWENTY -EIGHTH ANNUAL REVIEW  
3.1.  The Secretariat  provided an overview of t he Twenty -Eighth Annual Review, highlighting key 
findings related to the implementation and operation of the TBT Agreement. In terms of 
transparency, there was a slight decline in the number of new or changed TBT measures submitted . 
Still, developing  and least-developed Members were highly active, with African Members being the 
most active in submitting TBT notifications. The ePing platform was nearly universal for online 
notification submission. As for specific trade concerns, again, there was a slight decline in the number 
of new and previously raised STCs, with developing Members raising the majority of new STCs in 
2022. Participation in STCs broadened, with 33 Members raising at least one STC in 2022.  The full 
report is contained in the document G/TBT/ 50, issued on 6 March 2023.  
3.2.  The Committee  took note of the report.  
4  TECHNICAL  COOPERATION ACTIVITIES  
4.1.  The Secretariat  reported on technical assistance activities in 2022, which have picked up speed 
as Pandemic disruptions started to ease. In 20 22, twelve TBT TAs were organized: seven (five 
nationals and two regionals) were delivered in -person, while the remining five (all nationals) were 
delivered virtually. The Secretariat also provided many training sessions on transparency – including 
on ePin g – and launched the TBT Transparency Champions program .102 In 2023 (at the time of 
writing), 14 TAs were requested/planned, with ten already delivered: 11 in-person TAs (ten nationals 
and one regional); and three virtual TAs (two nationals and one regional).  
 
102 A detailed description on TA delivered in 2022 is contained in the Twenty -Eighth Annual Review, 
document G/TBT/50  (6 March 2023), paras. 6.1 to 6.4.  
 G/TBT/M/89  
 
- 124 - 
 
  5  OBSERVERS  
5.1  Updates from Observers  
5.1.  Updates were provided  by the following observers:  RSO (G/TBT/GEN/ 345), UNECE  
(G/TBT/GEN/ 346), BIPM (G/TBT/GEN/ 347), CODEX ( G/TBT/GEN/348 ) and IEC ( G/TBT/GEN/349 ). 
5.2.  The representative of OIML highlighted two items currently  being  worked on. They mentioned 
that a training course was being organized in association with the German Academy of Me trology in 
July of that year  on pre-packaged goods due to the increased importance of pre -packaged goods , 
particularly in developing economies. They also stated that they had been working with BIPM on 
developing some documentation and an e -learning package  on OIML D 1 , which is to do with a 
general law on metrology. The representative informed the Committee that once the simple 
brochures were available in a few months, they would be pro cessing that into an e -learning package 
enabling  senior decision -makers to understand the importance of a metrology law to the overall 
quality infrastructure of an economy.  
5.2  Pending requests  
5.3.  The Chair drew Members ' attention to a n updated list of observers, including pending requests, 
that was  contained in document G/TBT/GEN/ 2/Rev.17 . In addition, document RD/TBT/1/Rev.9  
provide d an updated compilation of the original communications received by the WTO from the 
various bodies that had sought observer status in the TBT Committee and whos e requests are still 
pending.  Regarding pending request s, he had no new information that would lead him to believe 
that the situation ha d changed from where the Committee stood at the last meeting. The Chair, 
therefore, suggest ed – unless any Members has a ny other view (or different information) – that the 
Committee reverts  to this matter  when Members ha d had the time to further consult.  
6  ELECTION OF CHAIRPERSON  
6.1.  The Chair noted that 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 th e current  agenda item would be  suspended  for the current meeting, and the Committee 
would revert to it at the next formal Committee meeting just after adopting  the agenda.  
7  OTHER BUSINESS   
7.1.  The Chair reported that, in accordance with a request from Paraguay, an item had been 
included for discussion under Other Business, which concerned the ongoing process under the CTG 
that was examining the functioning of Committees. The Chair also recalled that in la te October, the 
Chairs of the CTG subsidiary bodies had been requested to submit two reports to the CTG, one on 
the response to the pandemic and another on the current functioning of their committees. The final 
versions of the se two reports were circulated  on 1 December in documents G/TBT/48  and G/TBT/49 , 
respectively. The WTO Secretariat had also circulated a matrix to help compare the information 
provided in the 15 reports ( G/C/W/824 /Rev.1) . The reports from the subsidiary bodies, as well as 
the comparison matrix, had served as the basis for a discussion among Members during an informal 
meeting of the CTG on 31 January. During the meeting, many references had been made to the 
good practices of this Committee, such as the Triennial review process, thematic sessions, and the 
adoption of digital tools such as eAgenda and ePing. On 27  February, the CTG held another informal 
meeting on this topic, and a new multi -symbol document under co nsideration was a submission from 
Argentina, Ecuador, and Paraguay (also circulated as JOB/TBT/498 /Rev.1 ). Following this meeting, 
the Chair of the CTG sent another communication to the Chairs of all CTG subsidiary bodies, 
requesting them to organize dis cussions in their respective bodies concerning the functioning of their 
Committees. Later in the year, subsidiary bodies would be requested to submit written reports to 
the CTG describing the discussions held and improvements introduced.  
7.2.  The representative  of Argentina  presented the document JOB/CTG/21/Rev.1  and 
JOB/TBT/498/Rev.1  on behalf of all the co -sponsors (Argentina, Colombia, Ecuador, Paraguay and 
Uruguay). The document was produced based on the matrix presented by the Secretariat at the 
Council for Trade in Goods ( G/C/W/824) , which included the reports submitted by the 14 su bsidiary 
bodies.  The proponents had identified challenges to the functioning of the CTG and its subsidiary G/TBT/M/89  
 
- 125 - 
 
  bodies, particularly in processing the large volume of information arising from formal meetings, 
informal meetings and thematic sessions. These chall enges hindered the work of delegations, 
especially those with limited human resources, thus hampering progress on issues in what is a 
consensus -based organization. The purpose of the contribution was to create a common dialogue in 
the various subsidiary bo dies in order to align their practices and avoid the risk of increasing 
disparities in their operational processes. They highlighted specific suggestions and areas for action 
that they were putting forward for consideration . 
7.3.  The representative of Argentina  further noted that the document contained suggestions for 
improving the functioning of the Committee. The suggestions included the creation of a written 
manual and introductory sessions  for new delegates to assist them, the preparation of a style manual 
for formal meetings to reduce disparities in formatting, document content , and other processes , and 
improve the minutes/reports of the CTG's subsidiary bodies, alignment of agendas for informal 
meetings with those of formal meetings, holding thematic sessio ns within the framework of formal 
meetings, and the use of digital tools such as eRegistration, eAgenda, the online notifications 
system, and the Trade Concerns Database. The document also suggested that each subsidiary 
Committee define which of the sugges tions contained in the document would be useful to analyse  
its potential implementation or improvement in accordance with its own dynamics. A summary table 
was included at the end of the document that listed all the suggestions, with reference to the 
docum ent paragraphs where they were detailed and  aligned with their respective areas of action 
and related challenges. The document's authors  hoped it would serve as a basis for online discussions 
with the mandate received from their Ministries at MC12 and the recent communication of the CTG 
Chair in JOB/CTG/24 . 
7.4.  The Chairman suggested, i n light of the communication received from the CTG Chair and the 
paper just presented, that the Committee dedicate  some time to this topic at its next informal 
meeting.  
8  DATE OF NEXT MEETING  
8.1.  The next regular meeting of the Committee will take place on  21-23 June 2023. The regular 
meeting will be preceded by the Tenth Special Meeting on Procedures for Information Exchange on 
19 June and the thematic  sessions on 20 June. The dates for all meetings in 2023 are contained in 
document JOB/TBT/467 , issued on 8 June 2022.  The tentative dates for 2024 are contained in 
document JOB/TBT/500 /Rev.1 . 
 
__________