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RESTRICTED G/TBT/M/74 22 May 2018 (18-3001) Page: 1/49 Committee on Technical Barriers to Trade MINUTES OF THE MEETING OF 21-22 MARCH 2018 CHAIRMAN: MR JOSE MANUEL CAMPOS (CHILE) Note by the Secretariat 1 1 ADOPTION OF THE AGENDA ........................................................................................ 1 2 IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT ................................. 1 2.1 Statements from Members under Article 15.2 ................................................................. 1 2.2 Standardization Law of the People's Republic of China ...................................................... 2 2.3 Specific Trade Concerns (STCs) ..................................................................................... 3 2.3.1 Reported resolutions ................................................................................................. 3 2.3.2 Withdrawn concerns .................................................................................................. 3 2.3.3 New concerns ........................................................................................................... 3 2.3.4 Previously raised concerns ........................................................................................10 2.4 Exchange of Experiences .............................................................................................44 2.4.1 Eighth Triennial Review – Chairman’s report (JOB/TBT/240/Rev.2) ................................44 2.4.2 Other matters .........................................................................................................44 3 THE 23 RD ANNUAL REVIEW OF THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT (ARTICLE 15.3) ............................................................................ 47 4 TECHNICAL ASSISTANCE ACTIVITIES ....................................................................... 47 5 UPDATING BY OBSERVERS ........................................................................................ 48 5.1 Updates ....................................................................................................................48 5.2 Pending Requests .......................................................................................................48 6 DATE OF NEXT MEETING............................................................................................ 49 1 ADOPTION OF THE AGENDA The Committee adopted the agenda contained in WTO/AIR/TBT/10. 1.1. 2 IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 2.1 Statements from Members under Article 15.2 2.1. The Chairman reminded the Committee of Members' notification obligation under Article 15.2 of the TBT Agreement and further informed the Committee that the latest list of statements on 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.

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Page 1: RESTRICTED G/TBT/M/74 - docs.wto.org · reform of the solid waste import administration regime is one of the most important steps that the Chinese government has taken to implement

RESTRICTED

G/TBT/M/74

22 May 2018

(18-3001) Page: 1/49

Committee on Technical Barriers to Trade

MINUTES OF THE MEETING OF 21-22 MARCH 2018

CHAIRMAN: MR JOSE MANUEL CAMPOS (CHILE)

Note by the Secretariat1

1 ADOPTION OF THE AGENDA ........................................................................................ 1

2 IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT ................................. 1

2.1 Statements from Members under Article 15.2 ................................................................. 1

2.2 Standardization Law of the People's Republic of China ...................................................... 2

2.3 Specific Trade Concerns (STCs) ..................................................................................... 3

2.3.1 Reported resolutions ................................................................................................. 3

2.3.2 Withdrawn concerns .................................................................................................. 3

2.3.3 New concerns ........................................................................................................... 3

2.3.4 Previously raised concerns ........................................................................................10

2.4 Exchange of Experiences .............................................................................................44

2.4.1 Eighth Triennial Review – Chairman’s report (JOB/TBT/240/Rev.2) ................................44

2.4.2 Other matters .........................................................................................................44

3 THE 23RD ANNUAL REVIEW OF THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT (ARTICLE 15.3) ............................................................................ 47

4 TECHNICAL ASSISTANCE ACTIVITIES ....................................................................... 47

5 UPDATING BY OBSERVERS ........................................................................................ 48

5.1 Updates ....................................................................................................................48

5.2 Pending Requests .......................................................................................................48

6 DATE OF NEXT MEETING............................................................................................ 49

1 ADOPTION OF THE AGENDA

The Committee adopted the agenda contained in WTO/AIR/TBT/10. 1.1.

2 IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT

2.1 Statements from Members under Article 15.2

2.1. The Chairman reminded the Committee of Members' notification obligation under Article 15.2

of the TBT Agreement and further informed the Committee that the latest list of statements on

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.

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implementation submitted under this provision was contained in an annex to the Annual Review of the Implementation and Operation of the TBT Agreement (G/TBT/40), issued on 12 March 2018. Information on the list of statements is available on the TBT Information Management System (TBT IMS).

2.2 Standardization Law of the People's Republic of China

2.2. The representative of China introduced the newly revised Standardization Law of the People's

Republic of China. She said that the Law had been officially enacted on 4 November 2017 and had come into force on 1 January 2018. The draft law had been published online to solicit opinions not only from within the country but also from overseas. This had been done three times: in March 2016, May 2017 and in September 2017. The Law was divided into six chapters containing forty-five articles in total.

2.3. Regarding the major changes, the law expanded the scope of standards. Previously

applicable to "industry" standards only, the scope of standards had now been expanded to cover the "technical requirements" to be harmonized in the fields of agriculture, industry, services, social undertakings, etc." Second, the law encouraged active international participation. For the first time, the Law encouraged enterprises, social organizations, educational institutions, research institutes and other organizations to participate in international standardization activities. The law also promoted the application and popularization of international standards in China.

2.4. Third, the law strengthened and unified the management of mandatory standards. The

mandatory standard had been streamlined to achieve "one market, one bottom line, one standard". It clearly removed mandatory sector standards and mandatory local standards, and left only mandatory national standards. At the same time, the Law adopted the terms of WTO/TBT Agreement relating to technical regulation, for instance: the scope of mandatory national standards were strictly limited to "address technical requirements for ensuring people's health and the security of their lives and property, safeguarding national and eco-environmental security, and

meeting the basic need of economic and social management". Also, the Law stipulated that the

development of mandatory national standards had to be open and transparent while adequate notifications needed to be made to the WTO according to relevant rules. Fourth, the law introduced new requirements for standards development. The Law stipulated that during the proposal approval stage, investigations into the actual needs had to be carried out. During the standards development process, in-depth investigation and demonstration would be carried out and the process had to be open and transparent. After the release of standards, mechanisms were

established for feedback, evaluation and review on the implementation of standards

2.5. Since the promulgation of the new Standardization Law, China was actively studying the revision of the relevant laws and regulations. For example, China had released the Guiding Opinions for Foreign Invested Enterprises Participation in Standardization Work in China. This was done to promote the equal participation of foreign invested companies. This would mean, for instance, that participating subjects, joint ventures, cooperative enterprises and foreign invested companies legally created in China, would enjoy equal rights as domestic enterprises in the

national standardization work. In terms of scope of participation, the regulation clearly prescribed that foreign invested companies would take part in the drafting and translating of national standards, and propose advice and suggestions during the stages of proposal approval, feedback solicitation and standards implementation. In addition, China had already translated and published the English version of the new standardization law; the French, German and other foreign language versions of the law would be published soon.

2.6. The representative of the United States thanked China for the presentation on the

standardization law. For the United States it was a very important piece of implementation of the TBT Agreement and the US had made many comments on the Law. The US appreciated that the comments had been taken into account.

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2.3 Specific Trade Concerns (STCs)

2.3.1 Reported resolutions

There were no reported resolutions. 2.7.

2.3.2 Withdrawn concerns

The Chairman reported that the following STCs had been withdrawn from the agenda at the 2.8. request of the concerned Member:

a. China — Internet of Vehicles Cybersecurity Protection Guideline Rules

b. China — Civil Aviation Network Information Security Management Rules

2.3.3 New concerns

2.3.3.1 China — Chinese Environmental protection control standards for imported solid waste as raw materials

The representative of the European Union raised concerns regarding the Chinese 2.9.

environmental protection control standards for imported solid waste as raw materials. The full statement is contained in G/TBT/W/472.

The representative of the United States raised concerns regarding the Chinese 2.10. environmental protection control standards for imported solid waste as raw materials. The full statement is contained in G/TBT/W/468.

The representative of Australia expressed appreciation for China's efforts to reduce pollution 2.11. through a broad range of measures in the economy. Australia nevertheless had a number of

concerns about China's revised standards for certain waste and scrap imports and supported the comments raised by other Members. The standards would have a significant impact on Australian exporters, and might cause a large amount of waste to go to landfill, instead of being recycled in China and recovered for intermediate materials. What were the specific public health, animal or plant, and environmental protection objectives and how were they fulfilled by the measure?

Australia raised questions on: (i) how the contaminant levels had been set, requesting 2.12. further information about the technical and scientific analysis underpinning the standards; and

(ii) whether the measure was more trade restrictive than necessary to achieve the desired objectives. Australia was also concerned about compliance with the Code of Good Practice for the Preparation, Adoption, and Application of Standards in Annex 3 of the TBT Agreement. Neither the Ministry of Environmental Protection (MEP) nor SAC provided for a sixty-day comment period on the draft standards in either the domestic consultation process or the notification to the WTO,

according to Article L of the Code. Australia would also be grateful for an explanation on how

comments from other Members had been taken into account given the consultation process was closed and clarification on what regulations or standards were applied to China's domestic waste products, and how such standards were enforced. Were the domestic waste standards the same as foreign waste? If not, why not? Finally, Australia urged China to reconsider the standards and allow for a comprehensive consultation process.

The representative of Japan expressed appreciation for China's replies to the comments and 2.13. questions submitted to China's TBT Enquiry Point and relevant ministries to clarify the scope of the

regulation. However, it was suggested that China reconsider the regulation, as Japan could still see differences between standards applied to Chinese domestic waste products and to imported products. Japan once again requested China to grant equal treatment to both Chinese domestic products and imported products.

Concerning recovered paper and paperboard, Japan asked China to inform whether it 2.14. intended to revise the Waste Paper Recycled Requirements (GB/T20811-2006) which was applied to Chinese domestic products and about the timeline of its revision. Furthermore, Japan was

concerned about the impact the implementation of this regulation would have on other solid

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wastes. Since this regulation would have a huge impact on trade, her delegation asked China to share any further updates of the catalogue and to provide enough time to comment and a transitional period.

The representative of Canada thanked China for the presentation on the new standard 2.15. system and underlined its usefulness. Canada recognized China's desire to address environmental concerns related to trade in recyclable products. Canada had exported to China a wide range of

recyclable materials for use in industrial processes in the past few years such as paper mills and metal smelters. The delegation understood the role that such imports could play in the domestic economy as well as the importance of environmentally sound management of these materials. As also noted in its written comments on these measures, Canada would appreciate clarification on a number of aspects to ensure that the extensive trade in these goods could continue in a predictable way and not be overly burdensome for Chinese importers and Canadian exporters. In

particular, Canada sought further detailed information on the methodology used by China to

determine the allowable levels of "carried waste". Canada noted that the levels established by China were not in line with specifications commonly applied in the trade of these materials, as put forward by associations such as the Bureau International de Recuperation. Furthermore, Canada requested further information on how China planned to apply these standards in practice, including with respect to testing methodologies and the precise definition of "carried waste".

Canada recalled that in past statements, China had referred to a desire to completely 2.16.

eliminate the import of foreign waste and encouraged China to describe its intentions to regulate in this area and provide as much notice as possible for any future measures. The trade in recyclable materials between Canada and China was mutually beneficial: Canada was not able to process many of these materials as efficiently as China, and Canadian sources supplied valuable raw materials for Chinese companies. Import restrictions on those materials to China might increase prices and negatively impact the competitiveness of the Chinese processors. Canada encouraged China to consider all possible mechanisms which would not disrupt this lucrative trade.

The representative of China explained that since the 18th National Congress of the 2.17. Communist Party of China (CPC), the CPC Central Committee, with Xi Jinping at its core, had been pushing for ecological progress and pro-actively practising the values of "sustainable development" and "green development" in order to meet the Chinese people's over-growing need for a beautiful eco-environment, aiming to resolve significant outstanding environmental problems. Advancing the reform of the solid waste import administration regime is one of the most important steps that the

Chinese government has taken to implement the New Development Ideas, safeguard the eco-environment safety and population health. The representative further said that solid waste treatment and disposal was a shared environmental issue faced by all Members around the world. In accordance with the internationally recognized principles of "waste generator responsibility" and "disposal to the nearest", each Member had the obligation to dispose of domestically generated solid wastes. China, as a developing Member with the largest population, must make the inevitable choice of restricting and prohibiting imports of solid waste, whilst improving domestic solid waste

treatment and disposal. While China still welcomed the normal trade flow of raw materials processed from solid waste, the import of solid waste would be controlled and regulated to

safeguard eco-environment safety and population health.

Currently, China was seeking a path towards modernization that ensured the harmonious 2.18. co-existence of humans and nature. To that aim and with the objective of building a beautiful China, she said that China would continue to pro-actively practice the values of "sustainable development" and "green development", to unswervingly advance the reform of the solid waste

import administration regime, and push forward the ecological reform. In the process of adjusting relevant policies, the Chinese government would take into full consideration the calls from the domestic and international communities, coordinate economic growth and environmental protection, balance trade and non-trade interests, safeguard a smooth policy transition, and fulfil the applicable transparency obligation under the WTO. She added that over past decades, companies from many other WTO Members had exported huge volumes of solid waste to China

and obtained enormous economic benefits. China expressed hope that these Members could actively shoulder their international social responsibility while taking these advantages, and make due contribution to the improvement of environmental and health issues worldwide. China believed

that the most important thing for now was that all Members – not only China, but also the rest of the world - should follow the letters and spirit of the Basel Convention, reduce, process, and recycle hazardous wastes and other wastes produced within their own territory. With this

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consensus and subject to this condition, her delegation believed, many problems could be better solved and mutual understanding could be developed. It would also contribute to the global promotion of a green, low-carbon and recycling development mode, and the creation of a clean, beautiful world.

2.3.3.2 Israel — Addendum to the Pharmacist Regulations (Cosmetics 5778-2018) G/TBT/N/ISR/709/Add.2

The representative of the European Union expressed concerns on the "Addendum to the 2.19. Pharmacist Regulations ". The full statement is contained in document G/TBT/W/473.

The representative of the United States thanked Israel for agreeing to delay the review of 2.20. the final version of the Pharmacist Regulation in order to consult with industry. While appreciating the efforts of Israel to align its cosmetics regulations with international best practices by

introducing a transition to a notification system, there were concerns that the current draft

regulation might inadvertently cause trade barriers. US industry had submitted comments on the first draft proposed in 2013 and again last year, noting that the current requirements of the draft might result in market entry delays for US products. Israel's requirement that the Responsible Person (RP) should be an individual and not a business entity was neither in line with international best practices in investment policy nor would be realistic to implement since no one individual could be responsible for sometimes thousands of individual products that would need to be managed.

Additionally, the US understood that Israel required the Product Information Files (PIF) to 2.21. be kept at the address on the product label and asked for clarification whether this would require the PIF to be kept in Israel or at the site of a foreign manufacturer. If the former, then this requirement, along with the requirement that the PIF should be made available to authorities at any time, rather than within 72 hours of a request of an authority, put the Confidential Business Information (CBI) of US companies at risk. Businesses did not typically share all of the information

the PIF must contain, such as their product test data, rather only the relevant sections as needed

to address health authorities' requests. Similarly, while industry applauded holding parallel importers to the same standards as manufacturers by requiring them to designate an RP to facilitate the market authorization of their products, the fact that the RP of the associated cosmetic product must provide the PIF upon request from the authority was, in her delegation's view, an undue burden on the primary importer and put manufacturers' CBI at risk.

Further, the she asked whether Israel would consider the US industry's request to accept 2.22.

self-certification of GMP compliance. Industry also requested to permit providing drawings of product packaging rather than a photo or photocopy, because the final package design was not always ready at the time of notification. Industry further requested Israel to align with other markets that typically treated nano-material no differently from other forms of the same material. In doing so, Israel would avoid imposing a six-month waiting period specific to products containing nano-materials. The US asked Israel, following the March workshop, to review and address the comments that industry had provided to the TBT Enquiry Point and during the workshop. She also

requested Israel to re-notify the final draft given the extensive nature of the comments and the potential trade barriers and to provide a two-year transition period to adapt to the new measures once the regulation entered into force. She stressed that the US had exported over US$65 million in cosmetic products to Israel in 2016 and would appreciate cooperation in ensuring the trade was not interrupted.

The representative of Israel. She explained that the process to align Israel's cosmetics 2.23. regulations with international best practice had started in 2013. In this respect, the regulations

would signify a move from a pre- to a post-market control system to guarantee immediate access to Israel's market. It was noted that following the initial text notified in October 2013 (G/TBT/N/ISR/709), Israel had notified on 7 June 2017 and 23 January 2018 amendments to the regulations. The amendments had been made as a result of extensive consultation and commentary processes. She further added that the regulation aimed to improve the safety and quality of the cosmetics market in Israel and open it up to more competition. This was part of a

broader effort to lower barriers for imports into the Israeli market and to improve the quality and

prices of all goods for the consumer's benefit. As the process involved harmonizing the new regulations with those of its major trading partners, the Israeli Government appreciated and took into consideration contributions and experience-sharing of industry and trading partners in

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formulating the regulations suitable for the Israeli environment. The Israeli delegation took note of the issues raised in the Committee. Members were familiar with and had been actively involved in the process of developing the regulations. The discussions had been extended and were ongoing in the Israeli Parliament. She further encouraged concerned Members to continue contributing to deliberations through all channels. She also added that the period of implementation would be at least one year to allow industry to adapt to the new regulation. However, the date of the final

implementation had not been determined as the process to finalize the regulations was still ongoing.

2.3.3.3 European Union — Amendments to the Directive 2009/28/EC, Renewable Energy Directive

The representative of Malaysia raised concerns about the discriminatory treatment against 2.24. biofuels and bioliquids produced from palm oil under the proposed amendments of the Directive of

the European Parliament and of the Council on the Promotion of the Use of Energy from Renewable Sources adopted on 17 January 2018 by the European Parliament. She noted that the use of biofuels from palm oil would not be counted towards the EU's renewable energy targets from 2021 as compared to biofuels from other competing raw materials such as rapeseed oil which would be allowed until 2030. This, she maintained, would harm market access of palm-based biofuels to the EU and negatively impact the reputation of palm oil. Her delegation was concerned that the proposed amendments appeared to disregard the fact that the ambitious renewable targets by the

EU could not be achieved without the contribution of biofuels from palm oil. Palm oil was the most productive and efficient oil crop, only requiring one fifth of the land area required for rapeseed cultivation to produce a similar volume of palm oil. This minimized land-use change and reduced potential greenhouse gas (GHG) emissions from land conversion. Malaysia understood that the amendments were still being debated at the Trilogue negotiations in Brussels but was of the view that several amendments, particularly the provisions affecting biofuels produced from palm oil, would both constitute a breach of the EU's commitments under the TBT Agreement and affect

palm oil producing countries including Malaysia, if implemented in their current form.

The proposed Amendment 307 of the adopted text specifically singled out palm oil by 2.25. indicating that ''the contribution from biofuels and bioliquids produced from palm oil shall be 0% from 2021.'' Malaysia believed that the move to phase out the use of palm oil as a component of biofuels might constitute a violation of Article 2.1 of the TBT Agreement based on the following: (i) palm oil-based biofuels and other types of biofuels produced in the EU were "like products" as

they were used as a substitutable source of renewable energy and were in a competitive relationship; (ii) although the sustainability criteria applied to all vegetable oils that drove deforestation regardless of their origin, at least one of the sustainability criteria i.e. the 2021 target for palm oil, appeared to de facto discriminate against palm oil-based biofuels and create an advantage for other crop-based biofuels, particularly EU-produced biofuels; and (iii) the intended amendment would discriminate palm oil by singling out palm oil cultivation as the largest contributor to deforestation. Such a move was deemed protectionist in nature and unjustifiable,

undermining the principles of the multilateral trading system. Malaysia welcomed clarity on how such intended measures would be consistent with the TBT Agreement.

Malaysia was among several other Members to be most likely affected by the proposed 2.26. measures. Her delegation urged the EU to notify the measures to the TBT Committee swiftly in accordance with Article 2.9 of the TBT Agreement. Receiving more information on the draft measures at an early stage before they were finalized and adopted would give the opportunity for Malaysia and other Members to comment. Moreover, as a major exporter of palm oil products to

the EU, Malaysia continued to have concerns over EU's increasingly restrictive measures on palm oil. The amendments, if implemented in their draft form, would have negative repercussions on the palm oil industry of developing countries and did not reflect the stated commitment by the EU towards meeting the Sustainable Development Goals (SDGs), namely the objective of addressing poverty and raising the income levels of farmers.

It was noted that the proposed amendments also failed to recognize the positive impact of 2.27.

the Malaysian oil palm industry in enhancing the livelihood and the living standard of the 650,000 smallholders and the socio-economic development of the country through the export earnings from

the industry. The measure would negatively impact and deny those who were dependent upon the oil palm industry to lift from poverty. Also, the proposed amendments disregarded the initiatives by Malaysia in the efforts and measures implemented in forest and biodiversity conservation as

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well as the international pledges by Malaysia in the context of forest and tree covered conservation and reduction of GHG emissions. Malaysia had pledged under the Nationally Determined Contribution (NDC) of the Paris Agreement under the United Nations Framework Convention on Climate Change (UNFCCC) to reduce its GHG emissions intensity of GDP by 45% by 2030 relative to the emissions intensity of GDP in 2005.

The delegation of Malaysia further explained that palm oil was produced sustainably and the 2.28.

oil palm industry was committed to producing palm oil in accordance with sustainable principles and criteria under the Malaysian Sustainable Palm Oil (MSPO), which would be implemented on a mandatory basis by 31 December 2019. The proposed amendments undermined the efforts carried out by Malaysia to ensure the sustainable perspective of the Malaysian oil palm industry. Malaysia requested that the EU consider providing equitable treatment across all crop-based biofuels, including palm-based biofuels. Malaysia would continue to monitor the development of the

intended amendments of the EU RED and looked forward to the EU's response.

The representative of Thailand said that the adoption of amendments might affect the future 2.29. use and consumption of palm oil. Thailand understood that the adoption by the Parliament was not final, but that the measure would result in a reduction of biofuel produced from palm oil. At present, the EU's consumption of energy from renewable sources allowed the contribution from biofuels, bioliquids as well as from biomass fuels to be consumed in transport, if produced from food or feed crops, including palm oil. However, the adoption of the measure would remove palm

oil by the year 2021, while other similar raw materials would remain until 2030. Thailand considered that the phasing out of palm oil as a raw material for biofuel production was inconsistent with the TBT Agreement on the grounds of discrimination between palm oil and other types of vegetable oils. Thailand also considered that a particular product should not be treated in a discriminatory manner. Thailand would be grateful for updated information and clarifications from the EU. His delegation would continue monitoring the matter and looked forward to a constructive trilogue discussion in Brussels.

The representative of Indonesia welcomed the EU's engagement in currently ongoing 2.30. bilateral talks to discuss the revision of the Renewable Energy Directive (RED), but requested that the EU give a clear update at the TBT Committee. Indonesia understood that the purpose of the RED was to replace the use of petroleum-based fuels with renewable energy fuels to reduce the level of carbon dioxide (CO2) emissions that led to increased GHG emissions, to support environmental sustainability, and to diversify energy supplies in the EU by 2020. The vote in the

EU Parliament in January favoured phasing out the use of biofuel derived from palm oil as early as 2021. The measure applied only to palm oil and not to other vegetable oils which could serve as the ingredient to biofuel. He said that the Indonesian Government supported environmental sustainability and contributed to control deforestation. Government Regulation 104, adopted in 2015, tightened the permit for the conversion of forest areas. Land conversion could only be carried out to the unproductive area after research by an integrated team. Regarding global land use, palm oil only occupied 10% of land compared to the total land use of other vegetable oils.

The RED was of paramount interest to Indonesia because it would affect the livelihood of 17 million small-scale farmers in Indonesia who heavily depended on palm oil.

Indonesia was concerned that the final adoption of proposed provisions could have the 2.31. following impacts: (i) inhibit Indonesia's palm oil exports to the EU and establishment of new sustainable palm oil plantations in Indonesia, considering that Indonesia had committed to the 2015-2030 SDGs with the pillars of social, economic, environmental and sustainable development; and (ii) afford differentiated treatment between the use of palm oil as a biofuel feedstock

compared to the use of other vegetable oils. The European Parliament indicated that vegetable oils derived from other sources were still allowed to be used as biofuel feedstock while biofuel derived from oil palm would be phased out.

According to statistics, there had been a decline in Indonesia's CPO exports to the EU in the 2.32. previous three years (2015-2017). In 2015, Indonesia's CPO exports to the EU stood at USD 1.4 billion and declined to USD 895 million in 2017. Considering the importance of this issue to

Indonesia, the delegation believed that the EU should ensure consistency of the RED discussion with the provisions of the WTO.

The representative of Colombia raised concerns regarding the amendments to the 2.33. Renewable Energy Directive. The full statement is contained in G/TBT/W/465.

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The representative of Costa Rica joined the concerns raised by other delegations. Costa Rica 2.34. shared the objective pursued by the EU of promoting the use of renewable energy sources. However, it was essential that any restriction to the consumption of this product in the EU as a source of biofuels was based on risk analysis to guarantee that it was not a disguised restriction on trade. Further information was requested on the scientific basis that had led the EU to choose discriminatory treatment on palm oil-based biofuels.

The representative of Guatemala supported the concerns expressed. Under the proposed 2.35. measure, each member State must ensure that 12% of the energy consumed by transport came from renewable sources, of which no more than 7% should come from so-called "first generation" fuels (manufactured from food and feed) used for road and rail transport. Furthermore, the EU intended to ban the use of palm oil from 2021 onwards and considered palm oil production to be a key factor in deforestation. In Guatemala's views, the proposed measures contained discriminatory

treatment lacking any basis and put palm oil at a disadvantage compared to vegetable oils

produced by the EU. These new measures would affect around 60% of Guatemala's palm oil exports to the EU. The palm oil agro-industry was a source of direct employment in Guatemala and generated some 28,000 jobs, in particular in rural areas. Palm production in Guatemala covered over 165,500 hectares and accounted for 2.2% of the country's arable land. Meanwhile, Guatemala was recognized as the most productive country per hectare, the national average was 6.5 tonnes of crude palm oil, which equated to almost double the global production level. These

achievements stemmed from the commitment that Guatemalan producers had made to sustainability and good agricultural practices, which had enabled them to increase their efficiency per hectare and produce more with less. Moreover, in March 2017 and February 2018, some palm oil producing countries had sent to the Presidents of the European Parliament, European Commission and European Council an official note detailing the concerns about the measures, and yet Guatemala did not believe that these points had been taken into consideration. Guatemala reiterated its commitment to meeting the SDGs and its support for sustainable palm oil

certification to meeting the Millennium Goals. In light of the above, Guatemala requested open-ended participation in the discussions on this matter in Brussels and requested the European

Parliament, the European Commission and the member States of the EU to consider the arguments and devise non-discriminatory measures, according to WTO principles.

The representative of Nigeria echoed comments of other delegations and said that Nigeria, 2.36. as a palm oil producing country trading with the EU, would revert to the matter with substantive

concerns at a later date.

The representative of the European Union responded to the concerns raised. The full 2.37. statement is contained in G/TBT/W/474.

2.3.3.4 European Union — Laws, Regulations, procedures and guidelines on Marketing authorisation for medicinal products

The representative of India expressed concerns regarding granting market authorisations 2.38. for medicinal products, including generic, in the EU and its impact on the Indian pharma industry.

India understood that there were a number of authorities involved in the process, such as the European Medicines Agency, CHMP and separate authorities for each EU member State. He asked the EU to provide information and relevant documents to ensure a better understanding of the measure.

The representative of the European Union responded to the concerns raised. The full 2.39. statement is contained in G/TBT/W/475.

2.3.3.5 European Union — Application of Regulation No. 1169/2011 and Regulation (EC)

No. 1924/2006 as regards the labelling of food products, in not prohibiting or examining the use of "palm oil free" labels.

The representative of Colombia raised concerns regarding labelling requirements of food 2.40. products and the use of "palm oil-free" labels, in particular. The full statement is contained in

G/TBT/W/467.

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The representative of Indonesia joined the delegation of Colombia and stressed that the 2.41. issue was of particular interest for Indonesia. Her delegation had a specific view about the scientific evidence and would closely monitor developments and discussion on the issue. Indonesia reserved its right to raise the issue at the upcoming TBT meetings.

The representative of Costa Rica shared the concern of Colombia regarding the wide scope 2.42. of products in the European market using "no palm oil" labels which, in Costa Rica's view, was not

based on any scientific justification. It misled consumers into thinking that palm oil was not as good as other oils. There was no scientific justification for maintaining the labelling on a general basis that palm oil products were harmful to health, nor was there any basis which would justify using these labels on packets.

The representative of Guatemala thanked Colombia for including the item on the TBT 2.43. Committee meeting's agenda. Guatemala shared the concerns expressed by other Members and,

in particular, drew attention to the concern regarding EU measures and advertising campaigns against the consumption of palm oil and its use in various products. She noted that these measures and campaigns identified palm oil as a product that harmed health and environment; "palm oil-free" and "no palm oil" labels had negative impact and discouraged the consumption only of palm oil. This type of labelling misinformed consumers and in her delegation's view constituted a form of deceptive advertising. Guatemala believed that the EU measures discriminated against palm oil and other vegetable oils and similar European products. The measures neither considered

the efforts made by the palm oil agro-industry to ensure that production was sustainable and in conformity with international environmental sustainability standards, nor production differences between various palm oil producing regions and countries. Guatemala joined the questions posed by Colombia and expressed hope that the EU would provide clarification.

The representative of Thailand registered its interest in the matter along with other 2.44. delegations.

The representative of Malaysia supported the concern raised by Colombia, and would 2.45.

continue to monitor the development of the issue in the TBT Committee.

The representative of the European Union responded to the concerns raised. The full 2.46. statement is contained in G/TBT/W/476.

2.3.3.6 Thailand - New certification requirements under the Thai Ministry of Finance's Ministerial Notification on Importation of Spirits into the Kingdom of Thailand (B.E 2560)

The representative of Australia recognized the right of governments to take measures 2.47. necessary to protect public health and emphasized the importance of compliance with the TBT Agreement, in particular with the national treatment obligations and Article 2.2. He stressed that Australian exporters faced ongoing uncertainty regarding the implementation and certification requirements under the notification and needed clearer guidance in order to be able to comply.

Australian exporters were also concerned about the impact of the requirements on their business, in particular, the cost involved in additional testing and the potentially long wait times for test

results. Australia noted that the Certificate of Analysis must include an analysis of the liquor in accordance with the Thai Industrial Standard for Wine, Fruit Wine and other Fermented Beverages (TIS 2089-2544). In Australia, wine production was governed by Standard 4.5.1 of the Australia New Zealand Food Standards Code. His delegation asked whether Thailand would recognize official certificates guaranteeing compliance with Australia's requirements. He further requested clarification on whether testing of all 14 items listed in the Thai Industrial Standard was required if the use of the relevant material was not permitted in Australia or if the limit in Australia was the

same or higher than that specified in the Thai Industrial Standard.

The representative of the United States supported the comments of Australia on the 2.48. measure.

The representative of Japan expressed an interest in the issue and currently was carefully 2.49. reviewing the measure, including examination of the impact on businesses. Any information by Thailand would be appreciated.

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The representative of the European Union raised concerns about the regulation, in particular 2.50. concerning the certificate of analysis and possible impact of trade in alcoholic beverages. The full statement is contained in G/TBT/W/522.

The representative of Thailand explained that the purpose of testing and certification 2.51. requirements was to protect consumer health and safety. She reported that the Excise Department was in the process of preparing a notification to the TBT Committee. The ministerial notification

had been in force since 16 September 2017, however the Excise Department had announced that flexibility would be provided to the new requirements and that importers were allowed to provide the sampling analysis or certificate of analysis to the Excise Department within 30 days after importation. This flexibility had been extended to 14 September 2018. Thailand would convey Members' concerns to the Excise Department for their consideration and remained available to provide any further information on the ministerial notification.

2.3.4 Previously raised concerns

2.3.4.1 India — Pneumatic tyres and tubes for automotive vehicles G/TBT/N/IND/20 G/TBT/N/IND/40 (IMS ID 1332)

The representative of the European Union continued to raise concerns regarding India — 2.52. Pneumatic tyres and tubes for automotive vehicles. The full statement is contained in G/TBT/W/477.

The representative of the Republic of Korea reiterated previously raised concerns3 2.53.

requesting India to remove the discrimination between domestic and foreign companies and to eliminate the usage fee for ISI mark or at least reduce it.

2.54. The representative of India noted that this was an old STC, and recalled his delegation's previous statements on this issue, in particular in respect of the amount of marking fee, the

requirement of bank guarantee and the Scheme for Testing and Inspections (STI). With respect to the concern that BIS charged excessively high marking fee, India reiterated its position as expressed in previous meetings. He said that BIS was a non-profit organization and was not

guided by commercial interest, with marking fees aimed at covering administrative expenses (e.g. marking and testing of samples and other overhead expenses). The marking fee charged to foreign and domestic manufacturers was equal.

On the concern about the bank guarantee, he reiterated his delegation's previous response 2.55. that the performance bank guarantee was intended to protect the BIS during the tenure of the license and was invoked only in case of breach of any condition of the agreement signed between

BIS and licensee. This guarantee covered loss of revenue to BIS on account of non-payment of requisite marking fee. He mentioned that while compensation through court was available for breaches by domestic manufacturers, this was not possible for breaches by foreign manufacturers.

On the concern that testing requirements were burdensome and costly, India recalled its 2.56. statements at the November 2016, June 2017 and November 2017 Committee meetings, and noted the reduction in the sample size. He reiterated that as per the existing STI, the size of the control unit was up to 30,000 tyres manufactured under one family. Frequency of testing for

various requirements in STI was based upon their criticality with respect to the overall performance of the tyre. The frequency was every 60,000 tyres in case of Tyre Dimensions and Thread Bear Indicators, whereas the frequency was every 30,000 tyres for: Load/Speed Performance test; Endurance test; Bead Unseating Resistance test for tubeless tyres; and Tyre Strength test. India explained that this frequency was to ensure better quality control of the product performance under Indian climatic conditions, in the interest of consumers. Moreover, the aforementioned frequency was common for all BIS licence holders, whether domestic or foreign.

2 For previous statements follow the thread under IMS ID 133 (under dates raised and references). 3 G/TBT/M/73, para 2.2, G/TBT/M/72, para 3.56, G/TBT/M/71, para 2.62.

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2.3.4.2 China — Provisions for the Administration of Cosmetics Application Acceptance G/TBT/N/CHN/821 (IMS ID 2964)

The representative of Japan recalled China mentioning during previous meetings that the 2.57. "Guidance for Application and Evaluation of New Cosmetic Ingredients" would be revised in accordance with the revision of "Regulations concerning Hygiene Supervision over Cosmetics" and asked for an update on the status of any revisions. Japan also requested that China notify the

revisions in advance and provide a sufficient period of time prior to entry into force. Japanese cosmetics companies had reported concerns with safety evaluations, information disclosure requirements and the speed of examinations. In the end, some had abandoned their applications due to the requirement for evaluation of a single substance, which would be physically difficult to extract in some cases. Furthermore, details of production procedures and synthesis conditions of a new substance constituted confidential information. Therefore, some applications had been

withdrawn as the required information could not be obtained from the ingredient supplier. Since

the implementation of the current measure, only four new ingredients had been registered, and in some cases, the ingredients had remained unapproved for more than one year after the technical evaluation without any clear explanation for the delay. Given the circumstances, the use of new ingredients in products intended for the Chinese market was being avoided.

The representative of the European Union continued to raise concerns regarding the 2.58. Provisions for the Administration of Cosmetics Application Acceptance. The full statement is

contained in G/TBT/W/478.

The representative of China said that it had offered detailed explanations on the concerns, 2.59. most of which had already been raised in previous meetings. Since there were no updates, China invited interested Members to refer to the minutes of previous meetings.

2.3.4.3 India — New Telecommunications related Rules (Department of Telecommunications, No. 842-725/2005-VAS/Vol.III (3 December 2009); No. 10-

15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.III/Vol.II/(Pt.)/(25-

29) (28 July 2010); Department of Telecommunications, No. 10-15/2009-AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and Business Continuity Agreement") (IMS ID 2745)

The representative of the European Union continued to raise concerns regarding India's new 2.60. telecommunications related rules. The full statement is contained in G/TBT/W/479.

2.61. The representative of Japan expressed her delegation's support for the position or the EU.

With regard to the Unified Access Service License Agreement, Japan still had concerns on this new agreement and requested India to ensure that its telecom regulations did not impede market access for foreign industries. At previous meetings, India had noted that the deadline for the in-country security certification had been extended to April 2018 and might be further extended. Japan reiterated its request that the regulations be implemented in a transparent manner in terms of testing methods and certification requirements.

The representative of the United States said that several delegations in the TBT Committee, 2.62.

including the United States, remained concerned that India's telecommunications domestic security testing requirements could create an onerous and unnecessary trade barrier on Members' companies, particularly SMEs. The United States continued to request that India inform stakeholders of the new in-country testing effective date via a public notice and to send a notification to the TBT Committee. Moreover, the United States requested that India provide adequate time between the announcement of the effective date and the actual effective date for producers to comply. India had only identified security concerns and circumstances that existed in

most countries, and the United States continued to note that these countries generally did not find it necessary to require in-country testing or an MRA. India had thus failed to provide an adequate basis for this departure from international practice. As stated in previous interventions, security testing requirements that would potentially compromise companies' proprietary information such as source code and other intellectual property would create an unnecessary barrier. This was

4 For previous statements follow the thread under IMS ID 296 (under dates raised and references). 5 For previous statements follow the thread under IMS ID 274 (under dates raised and references).

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unacceptable to the United States. In addition, the US requested that India honour its commitment under the CCRA to accept the results of CC tests conducted internationally, and accept international testing standards and schemes regardless of whether the tests were performed in India or at accredited labs outside of India.

The representative of Canada reiterated concerns raised in the November 2016 TBT 2.63. Committee meeting6

The representative of India said that telecom networks were a part of the critical 2.64. infrastructure on which other critical infrastructures like power, transportation, defence relied on. It had been clarified in the past that India would rely on international standards to the extent possible. Additional tests could be conducted, if required in the interest of national security and public interest. Common criteria certification did not, India said, address national concerns on the security requirement of telecom networks. With respect to the in-country testing requirement and

the security certification thereof, it was noted that these guidelines could not be treated as trade barriers in view of the fact that the guidelines were equally applicable to the manufacturers/vendors irrespective of the source of procurement, including the domestic manufacturers. The deadline for the in-country security certification had been extended until 1 April 2018 and the notification was available on the website of the Indian Department of Telecommunications. The current status regarding security testing and certification requirements would continue until the extended date or further extension. Sufficient allowance would be made in

the provision of transition time to facilitate compliance with the requirements through an actual effective date for the network elements.

2.3.4.4 China — Requirements for information security products, including, inter alia, the Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial encryption products and its on-going revision and the Multi-Level Protection Scheme (MLPS); China — Banking IT Equipment Security Regulation; China — Insurance Regulatory Commission (CIRC) Information and Communication Technology

Regulation G/TBT/N/CHN/1172 (IMS IDs 294, 457 and 4897)

The representative of the European Union continued to raise concerns regarding the 2.65. adoption and entry into force of the new Cybersecurity Law for the existing rules, notably the MLPS and the OSCCA regulation on commercial encryption products. The full statement is contained in G/TBT/W/480.

The representative of the United States remained troubled about China's suite of measures 2.66.

that appeared to discriminate against foreign technologies and firms in the name of information security. This included China's Cybersecurity Law and draft insurance sector informatization rules, along with many other specific measures. The US shared the concerns raised by the EU and looked forward to continuing discussion with China on this important issue.

The representative of Japan supported the positions of the EU and US. Japan still had 2.67. concerns about the "Regulation on the Administration of Commercial Cipher Codes" and the MLPS.

The representative noted that at the previous meetings, China had stated that these two

regulations were in the process of amendment in line with the principles of the Cybersecurity Law. Moreover, in January 2018, China had invited public comments on the "Information security technology - Guidelines for grading of classified cybersecurity protection". Japan requested China to clarify the relation between these guidelines and MLPS and provide information on the revision of MLPS.

The representative of Australia reiterated previously raised concerns8 regarding the 2.68. proposed Insurance Regulatory Commission, Information and Communication Technology

Regulation, and the Banking IT Equipment Security Regulation. Australia understood China's desire

6 G/TBT/M/70, para 2.68 7 For previous statements follow the thread under IMS ID 294, IMS ID 457 and IMS ID 489 (under dates

raised and references). 8 G/TBT/M/73, para 2.22; G/TBT/M/72, para. 3.75; G/TBT/M/71, para. 2.162 and G/TBT/M/71, para.

2.175.

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to protect ICT infrastructure but said that the proposed measures might be more trade restrictive than necessary. Australia asked for further information on the status of the regulations and whether they would be permanently withdrawn.

The representative of China said that in order to implement the requirements of promoting 2.69. administration according to law, deepen the administrative reform and transform government functions in the domain of commercial cryptography, China was revising the Regulations on

Commercial Cryptography to further reduce the administrative licences, and strengthen supervision in the whole process. She said the revisions of the Regulations on Commercial Cryptography were still in the process of research. After the promulgation of the Law on Cryptography of the People's Republic of China, China would continue to revise the Regulations on Commercial Cryptography according to the Law on Cryptography, and release the Regulations for public consultation in appropriate time.

China explained that the Cybersecurity Law stipulated carrying out the cybersecurity MLPS 2.70. that was based on the experience in the past years. To fulfil the requirements of the Cybersecurity Law, the regulations on the cybersecurity MLPS were being drafted, which would replace the former administrative measures on the information security MLPS. Once completed, the regulation would be open for comments.

With respect to the Guideline for Promoting the Application of Secure and Controllable 2.71. Information Technology in Banking Sector (2014-2015), the representative said that it had been

suspended in April 2015, and had already expired. China would always abide by its WTO commitments, and be open and transparent in drafting the measures for commercial banking information systems. Regarding insurance, she said that the CIRC Regulation was still being drafted. She emphasized that during the whole process, China had been open, transparent, and had notified the WTO. China was studying and evaluating all comments, and bilateral communication and consultations were ongoing.

2.3.4.5 Russian Federation — Draft Technical Regulation on Alcohol Drinks Safety

(published on 24 October 2011), G/TBT/N/RUS/2 (IMS ID 3329)

2.72. The representative of Ukraine reiterated previously raised concerns10 and asked Russia to inform the Committee on the outcome of the internal consultations taking place among member states of the EAEU as well as on any modifications made to the measure.

The representative of the European Union reiterated previously raised concerns and 2.73. requested clarification on whether Russia intended to provide a written response to comments

submitted. The full statement is contained in G/TBT/W/481.

The representative of Guatemala reiterated her delegation's request for updated 2.74. information on any progress made in the internal discussions within the EAEU to review comments received on this technical regulation. She also requested a tentative date for a final version of the draft and enquired whether it would be notified to the WTO and with what date of entry into force.

The representative of the Russian Federation repeated the response provided at the 2.75. previous meeting of the TBT Committee.11

2.3.4.6 Republic of Korea — Regulation on Registration and Evaluation of Chemical Material G/TBT/N/KOR/305, G/TBT/N/KOR/305/Add.1, G/TBT/N/KOR/478, G/TBT/N/KOR/547, G/TBT/N/KOR/592, G/TBT/N/KOR/700 (IMS ID 30512)

2.76. The representative of the United States thanked Korea for their bilateral engagement, and in addition to recalling that the US concerns were well known, expressed a new concern by US industry, that polymer requirements did not correspond to the requirements in Korea's worker safety law.

9 For previous statements follow the thread under IMS ID 332 (under dates raised and references). 10 G/TBT/M/73, para. 2.26, G/TBT/M/72, para. 3.81, G/TBT/M/71, para. 2.79. 11 G/TBT/M/73, para. 2.30. 12 For previous statements follow the thread under IMS ID 305 (under dates raised and references).

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The representative of the Republic of Korea informed the Committee that the revised 2.77. version of the Act on Registration, Evaluation of Chemical Substances (G/TBT/N/KOR/700) had been made public on 20 March 2018 with an implementation date of 1 January 2019. Korea intended to collect opinions from stakeholders openly with respect to subordinate regulations through the pre-announcement of legislation. Additionally, according to this revised version, the annual report system would be removed. Finally, she recalled that Korea and the US had already

discussed bilaterally about the detailed information on CBI (Confidential Business Information) as well as the Worker Safety Law. In this respect, Korea had tried to reduce companies' burden, for example, by adopting a report system for new chemical substances in small volume and simplified documents for registration exemption of R&D usage. Korea intended to continue these consultations with Member in a transparent manner.

2.3.4.7 Indonesia — Technical Guidelines for the Implementation of the Adoption and

Supervision of Indonesian National Standards for Obligatory Toy Safety,

G/TBT/N/IDN/64, G/TBT/N/IDN/64/Add.1-2 (IMS ID 32813)

2.78. The representative of the European Union continued to raise concerns regarding the review of the Regulation of Minister of Industry No. 55 revising Regulation of Minister of Industry No. 24, which concerned the mandatory implementation of SNI (Indonesia national standard) for Toys. The full statement is contained in G/TBT/W/482.

The representative of the United States reiterated previously raised concerns14 and once 2.79.

again requested an update on the status of any revisions of the Ministerial Regulation. Her delegation stated that from the last TBT Committee meeting, it was not clear how the next revision of the regulation would treat the government-to-government Mutual Recognition Agreement (G2G MRA) requirement. She asked whether Indonesia intended to remove the MRA requirement in the next revision of the regulation and requested that Indonesia allow toy testing to be performed by any ILAC/MLA-accredited laboratory on a permanent basis, without requiring a G2G MRA.

Furthermore, her delegation understood that some overseas labs were currently permitted 2.80.

to perform toy testing provided that they had an agreement in place with an LSPro. She asked Indonesia to share more details on this and also the requirements for US labs to establish an agreement with an LSPro in Indonesia. She remained hopeful that the revised regulation would also address the lingering concerns as they related to testing frequency, sampling, documentation, and substance restrictions. Her delegation requested an update on Indonesia's deliberations on testing frequency and noted that she would like to see importers and domestic producers treated

the same with respect to testing frequency, and for these changes to be reflected in the next revision of the Ministerial Regulation.

The representative of Japan expressed support for the positions of the EU and repeated 2.81. concerns raised in previous meetings. Her delegation noted that in the previous meetings, Indonesia had explained that the draft Ministerial Regulation was still under review and the revision was expected to be completed by the end of 2017. She requested Indonesia to notify the regulation to the WTO in advance and to provide sufficient time until the date of entry into force in

accordance with TBT rules.

The representative of Indonesia explained that Indonesia had held bilateral meetings with 2.82. some Members to discuss the issue and informed the whole membership that the revision process was not yet concluded. Indonesia was developing a standard for toy safety which would correspond to the international standard, in this case the ISO, requiring efforts to bring different stakeholders together to reach a national consensus. On that note, she reassured Members that the revision process would be in line with WTO rules.

13 For previous statements follow the thread under IMS ID 328 (under dates raised and references). 14 G/TBT/M/73, para 2.32, G/TBT/M/72, para3.89, G/TBT/M/71, para 2.88.

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2.3.4.8 European Union — Draft Implementing Regulations amending Regulation (EC) No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products, G/TBT/N/EU/246, G/TBT/N/EU/246/Add.1 (IMS ID 34515)

2.83. The representative of Argentina reiterated previously raised concerns.16 His delegation

explained that Argentina complied in good faith with all the requirements established by EU law regarding the registration process for the traditional terms "Reserva" and "Gran Reserva". Nevertheless, at present, six years after having completed the substantive step for registration according to Regulations 607/2009 and 479/2008, the application had yet to be included for formal approval by the College of Commissioners. Argentina was concerned that its application was being intentionally blocked by the European Commission, and the EU had provided no legal justification

for this lack of action. Furthermore, the six years of procedural inactivity clearly demonstrated a

complete failure to perform the duties of sound administration and a breach of their obligation to act as quickly as possible, in line with the TBT Agreement. Argentina expressed serious concerns not only about the commercial impact of the EU measures, but fundamentally the unwillingness to resolve this issue and urged the EU to conclude without further undue delay the formal process for the approval of the registration of the traditional terms "Reserva" and "Gran Reserva".

2.84. The representative of the United States understood that the Commission had presented a

draft regulation to the European Parliament's Agriculture Committee. The US asked for clarification on the status of this draft regulation and when the EU would notify it to allow trading partners the opportunity to comment. Her delegation expressed regret at the EU's ongoing failure to provide updates on revisions to its draft regulation on geographical indications and traditional terms, and, more importantly, on applications for traditional terms which had been pending for eight years. US exporters had been unable to include the relevant terms on their exports to Europe despite being able to use them widely in other markets. While the EU appeared to be considering applications for

its member States, it had not been able to provide even basic information about whether US

applications were being considered which gave the impression that no action had been taken. In particular, the record of the Commission's 27 September 2017 meeting of its Committee for Common Organisation of Agricultural Markets – Subgroup Wine suggested that the Commission was processing applications for traditional terms from France and Croatia. The US asked for confirmation whether the EU was reviewing other applications. If so, she asked why the EU was

processing some applications but not others and what the EU was doing on applications from its trading partners. The US was concerned that the application process was simply a pretence for those outside the EU, and that it was well past time for action. She requested that the EU begin an expedited review of US applications and provide evidence that the review was actually taking place.

2.85. The representative of Brazil renewed its support to those raising concerns as this ordinance also raised obstacles to wine producers in Brazil. The regulation of terms that were currently in use

in the international market, without technical justification, created unnecessary barriers to trade. The fact that the EU had been analysing other countries' dossiers for eight years indicated that it

had been used as a non-tariff barrier and not to reach legitimate objectives established in the TBT Agreement. Brazil asked what steps the EU would take and the estimated timeframe related to the use of regulated terms in Regulation (EC) No. 607/2009 and Council Regulation (EC) No 479/2008 for wines exported to the EU.

2.86. The representative of the European Union responded to the concerns raised. The full

statement is contained in G/TBT/W/483.

15 For previous statements follow the thread under IMS ID 345 (under dates raised and references). 16 G/TBT/M/73, para 2.38, G/TBT/M/72, para 3.92, G/TBT/M/71, para 2.94.

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2.3.4.9 India — Electronics and Information Technology Goods (Requirements for Compulsory Registration) Order, 2012 G/TBT/N/IND/44, G/TBT/N/IND/44/Add.1-5, G/TBT/N/IND/47 G/TBT/N/IND/47/Add.1-3, G/TBT/N/IND/47/Add.1/Corr.1 (IMS ID 36717)

The representative of the European Union continued to raise concerns regarding India's 2.87. compulsory registration scheme for electronics and information technology goods. The full

statement is contained in G/TBT/W/484.

The representative of the Republic of Korea indicated that several bilateral meetings with 2.88. the Indian delegation had been held since 2015. Korea appreciated India's efforts and improvements; however, some concerns remained unresolved. Korea asked that Indian authorities accept test reports approved by the IECEE CB scheme. According to IECEE 02, India, as a member of the IECEE CB scheme, had an obligation to mutually accept test results of member countries. It

was indicated in Part 1 of the Rules of Procedure that if a member failed to comply with the obligation, it would face suspension of membership, expulsion etc. Accepting test results of laboratories accredited by the IECEE CB Scheme would eliminate the unnecessary burden on foreign companies and relieve a technical barrier.

The representative of the United States said that India's Compulsory Registration Order 2.89. (CRO) requirements continued to raise serious concerns, including the requirement that product testing be done only by Bureau of Indian Standards (BIS)-accredited labs located within India. The

US failed to see why India could not recognize test results from internationally accredited labs, particularly under the IECEE CB scheme, of which India was a member. She asked for an explanation as to why India refused to recognize test results from international accreditation schemes. While thanking India for notifying MEITY's expansion of the CRO product list (IND/44/Add 6) to the TBT Committee in November 2017, she also pointed out that it had been notified retroactively and without a comment and review period. The continual expansion of the list of products under the CRO was deeply disappointing as it created confusion, added unnecessary

burdens, and increased the cost of doing business in India. The current process for adding products under the CRO mandate created an uncertain and arbitrary market environment that added unnecessary burdens to exporters of Members. Based on the troubling and seemingly inexplicable aspects of the CRO, the only conclusion the US could reach was that the CRO was an unwarranted barrier to trade and the situation needed to be rectified.

The representative of the Russian Federation supported the concerns of other Members on 2.90.

compulsory registration requirements in India and expressed interest in further simplification of the procedure. Russia was interested in receiving additional information about the scope of the measure and any plans India had to change the scheme.

The representative of Canada expressed support for the previous interventions with respect 2.91. to the ongoing concerns related to India's Compulsory Registration Requirements.

The representative of India referred interested delegations to the statements made by India 2.92. in previous meetings. India had notified all relevant measures to the TBT Committee well in time.

The latest notification dated 6 November 2017 could be accessed in document G/TBT/N/IND/44/Add.6. It was important to reiterate that BIS accepted IECEE CB test reports for critical components under the BIS Registration scheme. Furthermore, the IECEE Publication "IECEE 01" specified the Basic Rules of the IEC Conformity Assessment Systems wherein the legal provisions of IECEE at the national level provided for the country law to prevail over any other obligation under IEC Conformity Assessment Systems. The matter of acceptance of CB test reports and certificates had been discussed between Indian authorities and IECEE officials in a meeting

held on 18 October 2013. In a joint communication issued on the matter, both sides had noted that India had not made any infringement of the IECEE Rules. Regarding the streamlining of procedures, India had informed the Committee during the June and November 2017 meetings that provision had been made for online acceptance of documents relating to the revision of IS 16046. The application for the granting of licences, inclusion of new models and the communications thereof were all made through the online portal, thus eliminating unnecessary delays. Even though

only test reports from BIS-recognised labs were accepted under the BIS Registration scheme, BIS

17 For previous statements follow the thread under IMS ID 367 (under dates raised and references).

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Lab Recognition Scheme (LRS) had criteria for recognition of overseas laboratories depending on MRAs with other countries. India welcomed further bilateral discussions with interested Members to discuss any concerns.

2.3.4.10 European Union — Revised Proposal for the Categorization of Compounds as Endocrine Disruptors of 19 February 2013 by DG Environment 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/SPS/N/EU/166, G/SPS/N/EU/166/Add.1 (IMS ID 39318)

2.93. The representative of the United States continued to raise concerns regarding the EU's hazard-based approach to regulating substances identified as endocrine disruptors. The US did not support the indiscriminate use of hazard-based criteria to ban substances. Despite the many interventions in the TBT Committee, it remained unclear how the EU intended to ensure that its regulatory approach was consistent with the provisions of the TBT and SPS Agreements. The US

asked that the EU explain how its approach provided a sufficient basis for achieving the objective of safeguarding human health and the environment by simply identifying hazards, and without identifying actual risks or reasonable methods for managing potential risks, so as to be no more trade-restrictive than necessary. Many of the substances that would be impacted by the EU's regulations were managed effectively under risk-based systems in other countries. Thus, the US found it difficult to believe that the only way the EU could manage these products was to ban them. These measures could become unnecessary barriers to trade and the TBT Agreement had

imposed disciplines on these types of measures.

The EU's approach to chemical regulation would remove many crop protection tools and 2.94. biocides from the market, even if these substances had histories of safe use in Europe and were still being used safely in other countries. The EU's update in December 2017 had not alleviated the US' concerns. Her delegation emphasized two points on this matter. First, the revised criteria for plant protection products endorsed by EU Member States in December 2017, and currently under scrutiny by the Parliament, if adopted, would lead to the banning of many more substances than

previously suggested in the EU's 2016 WTO notification, and its impact assessment report on criteria for identifying endocrine disruptors. Second, she recalled that in December 2016, the EU had excluded the amendment to its derogation criteria, making it effectively impossible to establish MRLs or import tolerances for substances identified as endocrine disruptors. Further, the US understood that the derogation for "serious danger to plant health" in Article 4.7 of Regulation 1107/2009 provided an avenue to allow the use of banned substances by EU producers in certain

circumstances, and to set MRLs under Regulation 396/2005. However, the US was unaware of any provision that would allow foreign producers to apply for such an exemption. Her delegation failed to see how public health was facilitated by making decisions simply on the basis of the applicant's domicile. A recent study estimated that the banning of crop protection tools and withdrawal of MRLs based on the EU's hazard criteria could adversely affect agricultural trade flows valued at approximately US$86 billion. This study estimated that US exports to the EU would be greatly impacted. Considering exports in relation to GDP, however, there would be a far greater and

disproportionate impact on the economies of many developing countries. Therefore, the US continued to remind the EU that there were other approaches to regulating these substances that

provided the high levels of human health and environmental protection sought by the EU without posing unnecessary barriers to trade. Additionally, her delegation stressed the importance of non-discrimination, transparency, and predictability in the implementation of TBT measures.

The representative of Canada reiterated previously raised concerns.19 Canada remained 2.95. deeply concerned with the EU's movement towards a hazard-based approach for regulatory

decisions for pest control products. It was at odds with good regulatory practice and the EU's WTO obligations. More broadly, Canada sought concrete assurances from the EU that decisions on setting MRLs will continue to be made on the basis of complete risk assessments, as set out in Regulation 396/2005.

The representative of Panama believed that the restrictions of pesticides were a serious 2.96. problem and the study that was mentioned by the US estimated the possible economic impact of

US$150 million or around 10% of its production value. The EU was Panama's main trading partner

18 For previous statements follow the thread under IMS ID 393 (under dates raised and references). 19 G/TBT/M/72, para 3.102, G/TBT/M/71, para 2.111.

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when it came to the exportation of coffee and tropical fruits. Therefore, his delegation asked the EU to review these policies and demonstrate some scientific basis in line with international standards and in line with international organizations such as the FAO.

The representative of Argentina reiterated previously raised concerns20 in the previous 2.97. Committee meeting. He asked the EU whether it will submit a new proposal to establish definitive criteria for substances with endocrine disrupting properties, in the terms requested by the

European Parliament, or whether the provisional criteria for these substances will be maintained over time, in accordance with the Regulation ( CE) No. 1107/2009. Argentina reiterated its request that, for substances with endocrine disruption properties as well as for any other substance that falls within the cut-off criteria, the EU maintains import tolerances, with maximum residue limits (MRLs) greater than the default values, taking into account what is established in Regulation 396/2005, in accordance with information and scientific evidence that is provided for this purpose

that demonstrates that said MRLs are safe.

The representative of Australia remained keenly interested in the EU's proposed approach 2.98. for regulating pesticides, including approaches for regulating endocrine disrupting chemicals (EDCs), and the herbicide glyphosate. His delegation thanked the EU for its ongoing engagement with Australia on these issues and looked forward to continuing this constructive engagement. He noted that in December 2017, EU member States had voted in favour of a new draft regulation setting criteria for the identification of endocrine disruptors used in pesticides and that this

regulation was undergoing scrutiny by the European Parliament. He also noted that the Council of the European Union had adopted the criteria on 27 February 2018. The regulation provided for the new criteria to be applied for the first approval of an active substance or at the time of renewal or review of its approval, for an active substance already approved. Australia was concerned that new regulatory decisions could be made that prioritized the review of some active substances regarded as meeting the new criteria, thereby reducing the transition period required for the industry to adapt to the new situation. This could disrupt Australia's premium grain, oilseed and horticultural

exports to the EU. Besides, on 27 November 2017 European member States had agreed to a five-

year renewal period for glyphosate rather than the fifteen-year maximum renewal period and on 6 February 2018 the European Parliament had voted in favour of establishing a Special Committee on the EU's authorization procedures for pesticides. Australia understood that, amongst other things, the Special Committee would assess potential failures in the scientific evaluation of the approval, or renewal of approval, of active substances such as glyphosate by relevant EU agencies

and possible conflicts of interest at all levels of the approval process. He believed there was sound evidence that glyphosate could be used safely.

The representative of Brazil supported the concerns raised by the US and Canada. 2.99. Regulation on endocrine disruptors should be established according to scientific principles and taking into account sound scientific evidence. Besides, it was necessary to use all available data in order to demonstrate that a substance was an endocrine disruptor. Prohibiting the use of a substance based on its potential impact on the endocrine system without sound scientific evidence

could create inaccurate safety concerns and reduction in the availability of food and food waste, besides causing unnecessary trade restrictions. In addition, the use of improper evidence could

result in the identification of endocrine-active compounds that did not have relevance to health or the environment. Evaluations must be able to separate chemicals that had the potential to cause harm due to their endocrine mode of action from those substances that did not pose a threat to human health. Furthermore, his delegation reiterated its concerns regarding the definition of MRLs and tolerance levels of these substances, which should be addressed according to the principles of

the SPS agreement.

The representative of Thailand supported statements made by other Members regarding 2.100. the revised proposal for the Categorization of Compounds as Endocrine Disruptors and reiterated its statement expressed in the previous meetings. While a number of Members had attempted to intervene in the EU's regulation, it had still been developed based on hazard cut-off rather than risk assessment criteria which would pose a great impact on international trade. Thailand hoped

that the EU would take its concerns into consideration.

20 G/TBT/M/73, para. 2.54

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The representative of Uruguay supported the statements made by others. The concerns 2.101. raised by Uruguay remained and he asked that reference be made to previous statements in the interests of time.21

The representative of Colombia remained interested in the matter. Her delegation 2.102. considered that any proposal on the criteria for determining the categorization of compounds as endocrine disruptors should be based on a risk assessment which would enable Colombia to

identify factually which compounds constituted a real risk to public health, respecting the fundamental principles of the TBT Agreement. She requested an update on progress made in the EU on this regulation.

The representative of Guatemala reiterated its concern on the EU regulation that 2.103. jeopardized agricultural products particularly on exports of developing countries. The definition identifying the criteria of endocrine disruptors as a hazard rather than a risk analysis as

established by Codex Alimentarius was of particular concern. Guatemala supported other Members' concerns in asking for clarification feedback as to whether there would be other public consultations during 2018 in Brussels.

The representative of the European Union responded to the concerns raised. The full 2.104. statement is contained in G/TBT/W/485.

2.3.4.11 Russian Federation — Safety of products for children and adolescents G/TBT/N/RUS/29 (IMS ID 41822)

2.105. The representative of the European Union continued to raise concerns regarding Russia's measure on the safety of products for children and adolescents. The full statement is contained in G/TBT/W/486.

2.106. The representative of the Russian Federation reiterated its statement from the previous

meeting.23

2.3.4.12 Thailand — Draft Notification of the Alcoholic Beverages Control, Re: Rules, Procedure and condition for Labels of Alcoholic Beverages, issued under B.E.,

G/TBT/N/THA/437, G/TBT/N/THA/437/Add.1 (IMS ID 42724)

2.107. The representative of the European Union continued to raise concerns regarding the Rules, Procedure and condition for Labels of Alcoholic Beverages. The full statement is contained in G/TBT/W/487.

The representative of the United States, whilst strongly supporting Thailand's efforts to 2.108. tackle the public health challenges associated with excessive alcohol consumption, again raised

concerns about the regulation. At the November 2017 TBT Committee meeting, Thailand said they had conducted a consultation on the guidelines to the regulation, and the United States requested

a status update on those consultations. She asked if Thailand intended to publish any information regarding its consultative process, or the comments it had received on the Internet, for interested stakeholders to review. The United States also asked whether Thailand was reviewing both the regulation and its guidelines. The United States again requested that Thailand suspend enforcement of the regulation until the review process was completed and US exporters had

certainty about the rules. At the same meeting, Thailand said they had published a preliminary assessment on warning labels for alcoholic beverages on the Internet. However, her delegation had been unable to locate that assessment, and therefore asked Thailand to provide the address of the website where it was located. Moreover, she asked for an update on Thailand's plans in this regard. The United Stated respectfully reminded Thailand of its obligation to notify the TBT Committee of any proposed changes to alcohol labelling regulations in order to provide interested stakeholders with the opportunity to comment before those regulations were finalized.

21 G/TBT/M/73, para. 2.55, G/TBT/M/72 para. 3.105; G/TBT/M/71 para. 2.118. 22 For previous statements follow the thread under IMS ID 418 (under dates raised and references). 23 G/TBT/M/73, para 2.66. 24 For previous statements follow the thread under IMS ID 427 (under dates raised and references).

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The representative of New Zealand acknowledged and supported Thailand's right to 2.109. introduce new regulations to address specific public health concerns. New Zealand appreciated that in seeking to address the harmful use of alcohol the technical regulation was directed to achieving a legitimate public health objective. However, New Zealand remained concerned that the labelling requirements in their current form were unclear and may be difficult to implement in practice. New Zealand asked if Thailand could update Members on the progress of any intended revisions to the

regulations and implementing guidance.

The representative of Guatemala recognized the need to protect the health of consumers 2.110. and the legitimate objective of Thailand to reduce alcohol consumption in its population. However, Guatemala considered that this measure could be more trade restrictive than necessary. At the November 2017 TBT Committee meetings, Thailand had informed the Committee that they would prepare an official report on the public consultation held in October. Guatemala asked whether

this document was available for consultation. Guatemala asked if Thailand could indicate when the

next public consultation related to this technical regulation would take place.

The representative of Australia reiterated previously raised concerns.25 2.111.

The representative of Japan shared the concerns raised by other Members, and requested 2.112. Thailand to provide new information taking into consideration the result of the consultation held in Thailand on 31 October 2017. Japan requested Thailand to sufficiently and appropriately amend the regulation before enforcement, considering all comments from concerned Members.

The representative of Thailand updated Members on progress on the technical document of 2.113. the regulation on the labelling control of alcoholic beverages. He recalled that at the previous meeting, his delegation had informed Members that at the end of October 2017, Thailand had convened a stakeholder consultation to gather comments and suggestions on the technical document of this regulation. In May 2018, Thailand would hold another stakeholder consultation to get views from civil society and other concerned groups, as suggested at the first consultation.

Thailand believed that this timeline would allow all other concerned stakeholders to be well

prepared in advance of the consultation. Thailand said the results and recommendations from both consultations would be proposed to the responsible working group and committees, to consider further improvement of the technical document. Finally, he informed Members that Thailand had posted the primary evaluation of the technical regulation on the website of the Center for Alcohol Studies of Thailand and the Office of Alcohol Control Committee. With respect to Thailand's pictorial warning measure, Thailand noted Members' concerns and reiterated that it would follow

the TBT Agreement and notify this measure to the TBT Committee in due course. Thailand also reaffirmed its right to protect the health of the Thai population, especially the young generation.

2.3.4.13 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 (IMS ID 42826)

2.114. The representative of the Republic of Korea noted that in licensing imported medical

devices, China only recognized test reports issued by China Food and Drug Administration (CFDA)-designated laboratories located in China. This led to unnecessary duplication of testing and additional incurred costs and delays. In this respect, Korea requested that China designate or recognize not only laboratories located in China but also those in foreign countries, or to recognize test reports issued by internationally accredited laboratories in the process of licensing imported medical devices.

2.115. The representative of the European Union continued to raise concerns regarding China's

Regulations for the Supervision and Administration of Medical Devices. The full statement is contained in G/TBT/W/488.

2.116. The representative of China recalled that it had provided detailed explanation for most of the questions raised at previous meetings. China updated the Committee that in January 2018, the

25 G/TBT/M/73, para 2.82, G/TBT/M/72, para 3.126, G/TBT/M/71, para. 2.141. 26 For previous statements follow the thread under IMS ID 428 (under dates raised and references).

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CFDA had released a guideline to instruct work on the acceptance of clinical trial results of medical devices overseas as clinical evaluation materials. These guidelines aimed to reduce the duplication of clinical trials, and to speed up the marketing process.

2.3.4.14 Kingdom of Saudi Arabia , Kingdom of Bahrain, State of Kuwait, Oman, Qatar, United Arab Emirates, Yemen — The Cooperation Council for the Arab States of the Gulf Draft Technical Regulation for "Requirements of Handling Energy Drinks",

G/TBT/N/ARE/262, G/TBT/N/QAT/389, G/TBT/N/SAU/669, G/TBT/N/SAU/789, G/TBT/N/ARE/299, G/TBT/N/BHR/426, G/TBT/N/KWT/309, G/TBT/N/OMN/238, G/TBT/N/QAT/423, G/TBT/N/SAU/910, G/TBT/N/YEM/29, G/TBT/N/ARE/301, G/TBT/N/BHR/428, G/TBT/N/KWT/311, G/TBT/N/OMN/240, G/TBT/N/QAT/425, G/TBT/N/SAU/912, G/TBT/N/YEM/31 (IMS ID 44227)

2.117. The representative of the European Union continued to raise concerns regarding the

regulation on the requirements of handling energy drinks. The full statement is contained in G/TBT/W/489.

2.118. The representative of Switzerland reiterated concerns raised in the previous meeting.28 Switzerland had submitted additional comments in December 2017 and looked forward to receiving replies. He requested that the GCC GSO take all the comments submitted into account.

The representative of the State of Kuwait informed the Committee that the GCC GSO was 2.119. still drafting the regulation based on comments received by Members. Any additional comments or

questions from Members would be sent to the competent authority.

2.3.4.15 European Union — Common Criteria for Information Technology Security Evaluation (Common Criteria) certification in the EU (IMS ID 44829)

2.120. The representative of China reiterated concerns raised in the previous meeting.30

2.121. The representative of the European Union provided further responses and arguments with respect to China's concerns with the Common Criteria Certification. The full statement is contained in G/TBT/W/490.

2.3.4.16 China — Administrative Measure on Cosmetics Labelling (AMCL) G/TBT/N/CHN/1064 (IMS ID 45631)

2.122. The representative of Japan reiterated previously raised concerns.32 Japan considered that the inclusion on the product label of all subcontractors in addition to the company with final legal responsibility would confuse consumers. On the evaluation of cosmetics efficacy claims, if China insisted on the disclosure of testing results, since the testing results could include protected know-

how, companies would no longer sell high performance products in China which would lead to these products no longer being available to Chinese consumers. Japan welcomed China's

confirmation that over-labelling would be allowed on imported cosmetic products and asked that their other concerns be given due consideration.

2.123. The representative of the European Union continued to raise concerns regarding China's Administrative Measure on Cosmetics Labelling. The full statement is contained in G/TBT/W/491.

2.124. The representative of New Zealand reiterated previously raised concerns.33 New Zealand

was encouraged by China's pilot trials to better facilitate trade, including of cosmetic products, and looked forward to seeing those trials applied nationally.

27 For previous statements follow the thread under IMS ID 442 (under dates raised and references). 28 G/TBT/M/73, para 2.88. 29 For previous statements follow the thread under IMS ID 448 (under dates raised and references). 30 G/TBT/M/73, para 2.85. 31 For previous statements follow the thread under IMS ID 456 (under dates raised and references). 32 G/TBT/M/73, para 2.90. 33 G/TBT/M/73, para 2.91, G/TBT/M/72, para 3.144, G/TBT/M/71, para 2.155.

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The representative of China said that the AMCL was still under drafting. Comments from 2.125. Members had been evaluated and studied. Labels in Chinese could be attached to the imported products consistent with relevant regulations and rules in China, following the international practices and proposals from Members.

2.3.4.17 China — Registration Fees for Drugs and Medical Device Products (IMS ID 46634)

2.126. The representative of the Republic of Korea expressed concern about China's discriminatory registration fees which imposed much higher fees for imported medical devices compared to those charged on domestically manufactured devices. China, it was noted, had responded that the higher registration fee was set for imported medical devices because it included costs for on-site inspection of foreign facilities. However, because on-site inspection of a foreign facility was not a requirement for all medical devices, Korea requested China to set the

registration fee for imported devices in a reasonable and transparent manner by separating on-site inspection costs from the total fee.

2.127. The representative of Australia expressed continued interest in this matter. Australian businesses had raised concerns regarding the China Food and Drug Administration's fee schedule and registration processes. Australia thanked China for the constructive bilateral discussions and looked forward to further cooperation.

2.128. The representative of China noted that the imposition of registration fees for drugs and

medical devices was common practice internationally. The registration fees in China were calculated on the basis of costs. The difference between the drugs and medical devices only reflected different workloads and pricing levels.

2.3.4.18 Brazil — Draft Ordinance Act Nº 374, 27 November 2014 (Portaria SDA/MAPA 374/2014) Establishes quality requirements for wine and derivatives of grape and wine,

G/TBT/N/BRA/613, G/TBT/N/BRA/613/Rev.1, G/TBT/N/BRA/675 (IMS ID 47035)

The representative of the European Union reiterated concerns regarding the draft 2.129.

ordinance establishing quality requirements for wine and derivatives of grape and wine. The full statement is contained in G/TBT/W/492.

2.130. The representative of Brazil stressed that the process relating to the measure at issue had been conducted in a very transparent manner, in accordance with the TBT Agreement. All comments had been taken into consideration and individual answers to specific concerns had been delivered. Brazil also reminded the EU that the Brazilian agricultural authorities had held a public

hearing on 27-29 June 2017. Also, it was appreciated that the EU recognize that many of its suggestions had been taken into consideration in the latest version of the Brazilian ordinance. It was noted that the technical regulation had been published in the Brazilian Official Journal on 9 March and notified to the WTO through document G/TBT/N/BRA/613/Rev.1/Add.1. The Regulation established a 360-day period of transition in order to allow industry to adapt and Brazil

was open to clarify all aspects of this regulation and to discuss with delegations who wished to further engage.

2.3.4.19 Brazil — Toy Certification; Ordinance No. 89, No. 310 and draft administrative rule No. 321 G/TBT/N/BRA/612, G/TBT/N/BRA/612/Add.1 (IMS ID 47836)

2.131. The representative of the European Union reiterated concerns regarding INMETRO's Ordinance No. 563 of 29 December 2016. The full statement is contained in G/TBT/W/493.

2.132. The representative of Canada echoed the concerns raised by other Members and requested updates regarding possible revisions to the Ordinance, in addition to whether any implementation guidelines were available for producers.

34 For previous statements follow the thread under IMS ID 466 (under dates raised and references). 35 For previous statements follow the thread under IMS ID 470 (under dates raised and references). 36 For previous statements follow the thread under IMS ID 478 (under dates raised and references).

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2.133. The representative of Brazil, in stressing the openness and transparency of the process, recalled that all comments had been taken into consideration. He confirmed informal information that a new public consultation would be open in April 2018 to all stakeholders, the scope and details of which were still being finalized. The review process was expected to be concluded, and the final technical regulation published, by January 2019.

2.3.4.20 China — Interim Measures for Quality Management of Commercial Coal

(IMS ID 47737)

2.134. The representative of Australia thanked China for the continued bilateral discussions over the previous three years, in the TBT Committee and other fora, regarding its coal standard and conformity assessment measures. China was Australia's second largest coal export market and there continued to be great interest from Australian industry and exporters regarding the implementation and application of these measures. Australia had exported 75.3 million tonnes of

coal to China in 2017, down by 19.5% compared to 2014, the last full year before the coal standards had been introduced. While Australia's coal exports had improved in 2016 compared to 2015, they had been stagnant in 2017. A survey conducted by the Minerals Council of Australia (MCA) among its coal industry members in late 2017 indicated that the introduction of the coal quality standards was continuing to have a negative impact on Australia's coal exports to China and the industry view was that the coal standards appeared to be inconsistent with WTO rules. Australia supported China's environmental objectives of improving air quality and promoting the

efficient and cleaner use of coal. However, retesting of coal in China was causing significant delays for Australian exports and adding greatly to costs of trade. Australian testing facilities were equipped to accurately test for quality standards and Australian coal was exceeding the high standards required. A free, open and transparent trade in coal would support China's objective of addressing the environmental impact of coal. Australia attached a very high priority to finding an amicable solution to the problem and believed that the easiest and quickest solution would be for China to accept coal test results by independent test laboratories in Australia, in line with other

coal importing countries.

2.135. The representative of China said that the interim measures for quality management of commercial coal had come into force in January 2015. Both imported coal and domestic coal in China were required to satisfy the same standards contained in the regulation.

2.3.4.21 India — The Stainless Steel Products (Quality Control) Order, 2015 (IMS ID 48638)

2.136. The representative of the European Union continued to raise concerns over this measure which constituted an unnecessary technical barrier to trade and discriminated against foreign producers. The full statement is contained in G/TBT/W/494.

2.137. The representative of India reiterated the response provided at the previous meeting of the TBT Committee.39 As regards risk perception on health grounds, the entire pipeline for water production including joints after reverse osmosis was required to be made of stainless steel in case

of packaged drinking water units. There were more than 5,500 manufacturers with valid BIS

licences in India. Similarly for the manufacture of utensils and kitchen appliances as per IS14756:2017, only 6 stainless steel grades covered under IS 5522:2014, IS 15997:2012 were permitted to date, taking into account the culinary practices in India.

2.138. Further, factory inspections were essential, including for the steel mills with ISO 9001 quality management system in place. The licence was granted, or inclusion in the existing scope of the licence was permitted, for the grade designations, sizes and varieties, specified in the standard only, after ensuring that the manufacturer had similar manufacturing and testing facilities.

2.139. His delegation explained that the Indian standards defined the permitted dimensions for stainless steel sheet, plate and strip for manufacture of utensils and kitchen appliances. On the other hand, there was no restriction on the dimensions of stainless steel covered under IS 6911 as

37 For previous statements follow the thread under IMS ID 477 (under dates raised and references). 38 For previous statements follow the thread under IMS ID 486 (under dates raised and references). 39 G/TBT/M/73, para 2.100, G/TBT/M/72, para 3.158, G/TBT/M/71, para 2.185.

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the said standard covered the stainless steel requirements for general engineering purposes and not for speciality products. Further, there were no restrictions on the surface finishes in all the three standards for the purpose i.e., IS 5522, IS 6911 and IS 15997. India looked forward to discussing any issues bilaterally should clarification be required.

2.3.4.22 India — Draft Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2015, G/TBT/N/IND/51 (IMS ID 49440)

2.140. The representative of the European Union continued to raise concerns regarding India's Alcoholic Beverages Standards Regulations. The full statement is contained in G/TBT/W/495.

2.141. The representative of Japan shared the concerns raised by the EU and noted that it had submitted comments to India's TBT Enquiry Point on 20 February 2018. In this respect, Japan asked India to provide the revised draft text taking into account Members' comments and also

asked India to reply to the comments Japan had submitted to India's TBT Enquiry Point.

2.142. The representative of India recalled responses provided in previous Committee meetings.41 Since then, his delegation had bilaterally passed on written responses of FSSAI to the concerned delegations, including to some of the queries raised by the EU during the November 2017 meeting. He also said that the Regulation might come into force six months after the date of final notification. Finally, he stated that the questions raised by Japan at the present meeting would be responded to shortly.

2.3.4.23 Indonesia — Halal Product Assurance Law No. 33 of 2014 (IMS ID 50242)

2.143. The representative of the United States reiterated concerns raised in previous meetings.43 The US was disappointed in the recent update from Ministry of Religious Affairs (MORA) that Indonesia would not allow a staged implementation of the Halal Law through 2024. Given the broad scope of the law, the US requested that the Government of Indonesia provide sufficient

transition time for stakeholders to provide feedback on, understand, and comply with requirements. She also noted that the lack of transparency regarding the draft regulations raised serious concerns and undermined confidence that the measure would be implemented in a fair and

trade-facilitating manner. Adhering to these core transparency practices would help ensure that exporters adequately understood Indonesia's requirements and that Indonesian consumers had access to products they preferred.

2.144. The representative of the European Union continued to have serious concerns with regard to the Indonesian Halal Product Guarantee Law No 33. The full statement is contained in G/TBT/W/496.

2.145. The representative of Australia reiterated previously raised concerns.44 His delegation asked Indonesia to confirm that existing halal certification systems would continue to be recognised by Indonesia. Australia respectfully maintained its position that Australian-based halal

certifiers should be able to provide halal certification for establishments across Australia. His delegation was aware that state-based restrictions on certifiers were not in place in other countries that exported halal products to Indonesia. Therefore, Indonesia's policy of limiting approved Islamic organizations to providing halal certification only in the state in which they were

headquartered was unduly restrictive and, moreover, did not serve to increase the halal assurance. Accordingly, Australia requested that this restriction be removed.

2.146. The representative of Brazil supported the concerns raised by the EU and the US and reiterated concerns raised in previous meetings.45

40 For previous statements follow the thread under IMS ID 494 (under dates raised and references). 41 /TBT/M/73, para. 2.123, G/TBT/M/72, para. 3.163, G/TBT/M/71, para. 2.197. 42 For previous statements follow the thread under IMS ID 502 (under dates raised and references). 43 G/TBT/M/73, para. 2.106, G/TBT/M/72, para. 3.168, G/TBT/M/71, para. 2.204. 44 G/TBT/M/72, para 3.170. 45 G/TBT/M/73, para 2.107, G/TBT/M/72, para 3.169.

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2.147. The representative of Indonesia reiterated responses provided in previous Committee meetings. Her delegation explained that the implementing regulation of the Law Number 33/2014 was being discussed among related government institutions to consider important issues such as mechanism of implementation, mechanism to differentiate between halal and non-halal products, process of certification and registration, etc. She also explained that as a new institution that was formed towards the end of 2017, the Agency of Halal Product Assurance (BPJPH) would need

adjustment, cooperation, and coordination to ensure effective implementation of the law, including implementing arrangement with all stakeholders at the central and regional level.

2.3.4.24 China — Formula Registration Regulation for Infant and Follow-up Formula, G/TBT/N/CHN/1165 (IMS ID 49346)

2.148. The representative of the European Union continued to raise concerns regarding China — Formula Registration Regulation for Infant and Follow-up Formula. The full statement is contained

in G/TBT/W/497.

2.149. The representative of the United States thanked the China Food and Drug Administration (CFDA) for providing additional information on Decree 26 over the past year, and for showing flexibility with regard to implementation dates for registration of infant formula and other "special foods". The United States supported other WTO Members' interventions on this issue, and sought confirmation that trade would not be unnecessarily disrupted. A number of issues still required clarification, and her delegation hoped that China could work with the United States and other

Members to avoid any trade disruptions.

2.150. The representative of Japan shared concerns raised by other Members. Japan was of the view that this measure would be more trade restrictive than necessary and would lead to a loss of sales opportunities for manufacturers. China was therefore expected to reconsider the measure.

2.151. The representative of China said that in respect of registration, China on the one hand

carried out review and approval works strictly following the rules, and on the other hand, made efforts to secure smooth transition and stable supplies in the market. As of 23 February 2017, the

CFDA had approved 1138 formula in 148 enterprises, comprising 864 formula in 102 domestic enterprises and 274 formula in 46 overseas enterprises. She added that 106 enterprises had registered 3 series 9 formula. The formula approved accounted for 74.2% of total formula accepted, covering most domestic and overseas brands. For further information, Members were invited to refer to CFDA's website.

2.3.4.25 Russian Federation – Rules of cement certification G/TBT/N/RUS/48,

G/TBT/N/RUS/49(IMS ID 49747)

The representative of Ukraine reiterated previously raised concerns.48 2.152.

The representative of the European Union continued to raise concerns regarding Russia's 2.153.

rule of cement certification. The full statement is contained in G/TBT/W/498.

The representative of Mexico reiterated previously raised concerns.49 She reiterated that 2.154. her delegation believed that Russia could be infringing Articles 5.1.1, 5.1.2 and 5.2.1 of the TBT Agreement, as applying a conformity assessment procedure to imported cement had

discriminatory and trade-restrictive effects and resulted in higher costs for importers of the product. She urged Russia to take into account comments made by countries affected by the measure and requested clarification regarding the application of the conformity assessment procedure to shipments of cement from third countries destined for countries in the Eurasian region.

46 For previous statements follow the thread under IMS ID 493 (under dates raised and references). 47 For previous statements follow the thread under IMS ID 497 (under dates raised and references). 48 G/TBT/M/73, para 2.111 49 G/TBT/M/73, para 2.112, G/TBT/M/72, para3.178, G/TBT/M/71, paras 2.218-2.219.

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The representative of the Russia Federation recalled statements made during previous 2.155. Committee meetings50, explaining the reasons for mandatory certification of cement. The practice of GOST-R application had shown necessity for some changes. In order to implement them, draft amendments No. 2 to the GOST-R had been developed and published on the web site of the Federal Agency for Technical Regulation and Metrology. Public consultations on the draft had ended on 1 March 2018. Now the draft was being finalized taking into account the comments

received during public consultations. The document, inter alia, provided for elimination of additional inspection control. Russia continued to analyse the practice of application of cement certification rules in light of the concerns of interested Members.

2.3.4.26 Egypt — Manufacturer Registration System (Decree No. 43/2016 and Decree No. 992/2015) G/TBT/N/EGY/114, G/TBT/N/EGY/115 (IMS ID 50551)

The representative of the European Union continued to raise concerns regarding the 2.156.

implementation of the Egyptian decrees. The full statement is contained in G/TBT/W/499.

2.157. The representative of the United States supported the concerns raised by other Members and remained concerned about the lack of transparency concerning this measure, as well as its application, which appeared to be unnecessarily burdensome for US exporters.

2.158. The representative of Switzerland reiterated concerns raised in previous meetings.52 In addition, his delegation remained concerned about the non-transparent application of the quality certification and registration requirements. The lack of time limits for the registration process and

the following decree by the Minister of Foreign Trade was an important additional burden for industry, as the approval of registration requests remained uncertain and progressed slowly. The renewal of registrations also contributed to the problems of industry. These requirements had driven Swiss companies out of the Egyptian market. Finally, he thanked Egypt for the bilateral exchanges and looked forward to further cooperation on the issue.

2.159. The representative of Canada reiterated concerns raised in previous meetings53 regarding the registration requirements for overseas factories manufacturing toys, supported the concerns

raised by other Members, and looked forward to Egypt's response.

2.160. The representative of Egypt reiterated responses provided in previous meetings.54 In addition to the previous explanations regarding the transparency commitments, her delegation stated that once the registration process was finalized, the concerned companies were duly informed and the list of approved companies was made available at the database of the General Organization of Exports and Imports Control for reference by economic operators. With regard to

the complication of the registration process, she explained that the documents required for registering any factory or company included a certificate of the legal status, the trademark owned, and a certificate to prove that the factory implemented a quality control system issued by any conformity assessment body accredited by entities that were in turn accredited by ILAC or IAF. These required documents were documents that any credible entity should hold and it was intentional not to require any specific quality control system certificate in order not to create any

unnecessary barrier to trade. Besides, no renewal of the registration was needed as long as the

documents submitted were valid. Lastly, she urged those who had specific concerns to communicate them to her delegation. She had taken note of the comments made in the meeting and would convey them to capital for response in due course.

50 G/TBT/M/73, para 2.113, G/TBT/M/72, para 3.181. 51 For previous statements follow the thread under IMS ID 505 (under dates raised and references). 52 G/TBT/M/73, para. 2.144, G/TBT/M/72, para. 3.184. 53 G/TBT/M/73, para. 2.145 54 G/TBT/M/73, para. 2.148, G/TBT/M/72, para. 3.186.

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2.3.4.27 Kenya, Uganda, Tanzania, Rwanda, Burundi — East African Community alcoholic beverage standards, G/TBT/N/KEN/472-477, G/TBT/N/KEN/479, G/TBT/N/KEN/482-483, G/TBT/N/KEN/556-561 G/TBT/N/KEN/563-565 G/TBT/N/KEN/567, G/TBT/N/UGA/434-435, G/TBT/N/UGA/437-441 (IMS ID 510 and 51955)

2.161. The delegation of the European Union expressed support to the Members of the East

African Community (EAC) in their efforts to ensure the quality standards of alcoholic beverages consumed in their territories. The full statement is contained in G/TBT/W/500.

2.162. The representative of the United States reiterated her delegation's appreciation for the efforts by Kenya and other EAC countries to notify their revised draft regional EAC alcohol standards and for providing the opportunity for Members to comment. She thanked Uganda for providing written responses to US comments. Her delegation was of the understanding that EAC

members were still revising the draft standards following comments from the US and other trading partners. A status update on those revisions and on anticipated timelines for completion was requested.

2.163. The representative of Kenya (on behalf of EAC) reiterated the response provided during previous Committee meeting.56 In addition he reported that the public review comments had been compiled, reviewed and concluded in a regional meeting of the Technical Committee on Alcoholic and Non-alcoholic Beverages, held from 5-9 March 2018 in Nairobi, Kenya. In this meeting, the

standards had been released to proceed to the approval process after which they would be gazetted as East Africa Standards. The EAC partner states would thereafter adopt the gazetted standards as National Standards, thereby making them available for use by the stakeholders. Kenya was ready for further engagement with the delegations of the EU, US and others on this issue.

2.3.4.28 European Union — Quality Schemes for Agricultural Products and Foodstuffs,

G/TBT/N/EU/139, G/TBT/N/EU/139/Add.1 (IMS ID 51257)

The representative of the United States reiterated previously raised concerns with the 2.164. recent registration of the name "danbo" as a protected geographical indication (PGI).58 The US had found the consultation process unsatisfactory and lacked sufficient transparency, such as an explanation as to how the Commission considered the existing Codex standard. Accordingly, she asked what the grounds were for rejecting an application where concerns had been raised by WTO Members producing generically named cheeses.

2.165. The US considered this a TBT matter and disagreed with the previous EU claim that this should be discussed in a GI-focused forum. The EU had correctly notified its quality schemes regulation under the TBT Agreement precisely because of its TBT implications, such as the labelling elements and relevant international standards, in particular the Codex standard for danbo, which had existed for over 50 years, and which Codex members, including the EU, had reconfirmed in 2007, 2008 and 2010.

2.166. The Council's own decision on the EU's accession to the Codex Alimentarius Commission

affirmed that "Codex standards have acquired increased legal relevance by virtue of the reference made to Codex in the WTO Agreements and the presumption of conformity which is conferred on national measures when they are based on such standards". The EU and its member States also supported and agreed to the Codex Committee for Milk and Milk Product Individual Cheese standards, containing labelling provisions under section 7, preserving the generic nature and use of the names of these cheeses. Danbo was one of these cheeses, which underwent a rigorous review to prove its use in public domain and international trade. She asked if the Commission's

view of the legal relevance of Codex standards had changed since the publication of the Council

55 For previous statements follow the thread under IMS ID 510 and IMS ID 519 (under dates raised and

references). 56 G/TBT/M/73, para 2.138 57 For previous statements follow the thread under IMS ID 512 (under dates raised and references). 58 G/TBT/M/73, para. 2.129.

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Decision. She also requested a status update on the Havarti application where the US hoped there would be a different outcome.

The representative of Uruguay raised concerns with the Quality Schemes for Agricultural 2.167. Products and Foodstuffs. The full statement is contained in G/TBT/W/469.

The representative of the European Union responded to the concerns The full statement is 2.168. contained in G/TBT/W/501.

2.3.4.29 The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu – Draft of the Organic Agriculture Act, G/TBT/N/TPKM/225, G/TBT/N/TPKM/225 Add.1-2 (IMS ID 51159)

2.169. The representative of the European Union continued to raise concerns regarding the Draft

Organic Agriculture Act. The full statement is contained in G/TBT/W/502.

The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and 2.170.

Matsu explained that the Organic Agriculture Promotion Act had been drafted by incorporating comments from all stakeholders. This draft was still under review by legislators and no further information on the status of this process was available beyond what had already been expressed in the previous meeting. Chinese Taipei invited Members to consult the statements it had made in previous meetings, including its explanations on the extension of the grace period from one to two years as well as on the two routes the draft now provided for trading partners to export their organic products to the Chinese Taipei market.

2.3.4.30 China — National Standards on Limits of Volatile Organic Compounds for Furniture, G/TBT/N/CHN/1094, G/TBT/N/CHN/1095, G/TBT/N/CHN/1096 (IMS ID 50960)

2.171. The representative of the European Union continued to raise concerns regarding China's National Standards on Limits of Volatile Organic Compounds for Furniture. The full statement is contained in G/TBT/W/503.

The representative of China informed the Committee that the six measures contained in 2.172.

"Deepening the Reform Programme of Standardization Work" had simplified and integrated all mandatory standards, including those related to the furniture industry. On 14 January 2017, the China National Standardization Administration Committee had published the conclusion of the simplification and integration of Chinese mandatory standards contained in the notice "Notification of the issuance of conclusion of the simplifying and integrating of Chinese mandatory standards" (No.4 document of SAC in 2017). In this conclusion, the "Limit of volatile organic compounds and

migration of heavy metal of wood based furniture", "Upholstered furniture - Limit of volatile organic compounds, decomposable aromatic amine and flame retardant of mattress" and "Upholstered furniture - Limit of volatile organic compounds and decomposable aromatic amine of

sofa" had not yet been included. As a result, these three national standards had not yet been published and implemented. According to the relevant requirements of "Notification of completing the follow-up work for the conclusion of the simplifying and integrating of mandatory standards" (No. 464 document of Department of Science and Technology, Ministry of Industry and

Information Technology in 2017), the integrating and development work of standards was ongoing.

2.3.4.31 Korea — Amendment of the Notifications on Warning Messages on Smoking and Drinking (IMS ID 51861)

The representative of the European Union continued to raise concerns regarding Korea's 2.173. amendment of the notifications on warning messages on smoking and drinking. The full statement is contained in G/TBT/W/504.

59 For previous statements follow the thread under IMS ID 511 (under dates raised and references). 60 For previous statements follow the thread under IMS ID 509 (under dates raised and references). 61 For previous statements follow the thread under IMS ID 518 (under dates raised and references).

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The representative of Japan reiterated concerns raised in previous meetings62 and 2.174. requested that Korea reply to the comments submitted to the Korean TBT Enquiry point on 20 February 2018.

The representatives of New Zealand, Australia and Chile reiterated concerns raised in 2.175. previous meetings and supported the concerns raised by other Members.63

The representative of the Republic of Korea appreciated that Members understood the 2.176.

purpose of the regulation. He informed the Committee that imported alcoholic beverages, containing the old warning labels that had cleared customs before 8 February 2018, could be sold to customers. This would solve any stock problems. Korea would continue consultations with Members and stakeholders to resolve all concerns in a transparent manner.

2.3.4.32 Kazakhstan, Russian Federation — The amendments No. 2 to the Technical

Regulation of the Customs Union on Safety of Toys (TÐ ÌÑ 008/2011) GTBT/N/KAZ/7,

G/TBT/N/RUS/73 (IMS ID 51464)

The representative Ukraine reiterated concerns raised in the previous meetings.65 2.177.

The representative of the European Union continued to raise concerns regarding the 2.178. amendments to the Safety Toy EAEU Technical Regulation. The full statement is contained in G/TBT/W/505

The representative of the United States said that, during the November 2017 Committee 2.179. meeting, the Kazakh delegate indicated that Kazakhstan was continuing to take comments

received during public consultation and during the TBT Committee meetings into account. The Kazakh delegate noted that Kazakh agencies were considering the ISO standard. She requested clarification on which government agency was overseeing the process, and any update on the possibility of replacing the psychological and pedagogical criteria with age grading requirements

based on the ISO standard. The US suggested that Kazakhstan explore less trade restrictive alternatives to achieve its objective. For example, age grading — a globally-recognized practice cited in international standards — could be applied to ensure children's access to toys that were

appropriate and safe for particular stages of physical and mental development. As noted in ASTM F963-16 Annex A1, "age grading is intended to provide point of sale guidance to consumers for the selection of appropriate toys for children with respect to average abilities, interests of various age groups, and safety aspects of the toys themselves." The US also requested Kazakhstan to consider the unintended consequences of implementing the measure, as amended, because it could potentially eliminate toys representing children with disabilities from the market.

The US supported the Eurasian Economic Commission's desire to protect the psychological well-being of children and welcomed continued discussions with EEC members to achieve this objective in a way that does not unnecessarily restrict trade.

The representative of Canada echoed the concerns raised by other WTO Members. 2.180.

The representative of Kazakhstan drew Ukraine's attention to the fact that its comments 2.181. referred to the existing provision of the technical regulation which was adopted in 2011. She also said that the public consultations on the draft technical regulation took place in July-August 2010.

No comments or questions from state bodies or private sector of Ukraine were received in the course of that public consultation. Certification of conformity of toys has always been applied in Kazakhstan, even before the adoption of the customs union technical regulation on safety of toys. Kazak authorities have never registered any problem with obtaining conformity certificates for products originating from Ukraine. In this respect, she noted that the TBT Agreement did not preclude a Member from choosing a type of conformity assessment scheme which it considered appropriate in ensuring its legitimate objective. Kazakhstan referred, in this respect, to its previous

answers made in the previous TBT Committee meeting. With respect to the questions of EU and US, Kazakhstan noted that there has been no substantive discussion within the EAEU working

62 G/TBT/M/73, para. 2.160. 63 G/TBT/M/73, para. 2.161, G/TBT/M/73, para. 2.162 and G/TBT/M/72, para. 3.212, respectively. 64 For previous statements follow the thread under IMS ID 514 (under dates raised and references). 65 G/TBT/M/73, para 2.169.

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group since March 2017. During this time, Kazakhstan's relevant government agencies have been studying the ISO standard in this field. Kazakhstan could, preliminary, say that there was positive consideration of the possibility to implement this ISO standard. Among other aspects, the internal discussion was being held on how the ISO standard could be applied or adopted into Kazakhstan's legal framework.

2.3.4.33 Russian Federation — Medical Devices, G/TBT/N/RUS/51, G/TBT/N/RUS/52,

G/TBT/N/RUS/53, G/TBT/N/RUS/55 (IMS ID 52066)

The representative of the European Union continued to raise concerns regarding the 2.182. Russian Federation's four notifications on medical devices. The full statement is contained in G/TBT/W/506.

The representative of Ukraine said that the requirements of the draft agreement needed to 2.183.

be justified on the basis of provision of a scientifically substantiated clarification concerning the

application of the sticker conditions for exporters compared with domestic producers, which related to the mandatory state registration. State registration of medical devices was based on the examination of safety, quality and effectiveness of medical devices, which were conducted by expert authorities defined by the member state of the Eurasian Economic Union (EAEU). The mandatory requirement for applicants to register on the territory of member states of the Eurasian Economic Union put national producers and producers from other WTO Members in unequal positions. Application of conformity assessment procedures depended directly on the justified

risks, i.e. the higher risk, the harder the procedure. The use of certification as a conformity assessment procedure by the Russian Federation showed that there were high risks in the case of imported products, as opposed to the case in many WTO Members where product declarations were applied in case of low risks. The reference of the representative of the Russian Federation to the existence of a transition period of the draft agreement before its entry into force was not sufficient to level the playing field. The draft agreement specified requirements for implementation, installation, repair and disposal of medical products, which were not in line with

the requirements of international practices. Ukraine called on the Russian Federation to remove unjustified technical barriers to trade and bring the provisions of the draft documents on medical devices in line with the requirements of international practice.

The representative of the Russian Federation recalled that in order to establish a single 2.184. market of medical devices in the EAEU, the relevant treaties had entered into force on 6 May 2017. However, their entry into force did not mean significant changes in the existing system of

registration. Producers and importers could register medical devices either in the national system of registration or in the system of the EAEU. Registration certificates issued in Russia would be valid only on the territory of Russia. Registration certificates issued in accordance with the rules of the EAEU would operate on the territory of all countries of the EAEU. The transitional regime would last until 31 December 2021. In 2022, the Russian registration system would be completely replaced by the supranational system of the EAEU. However, national registration certificates issued previously would be valid until 31 December 2025, if not otherwise indicated in them.

During the transitional period until 31 December 2021, a special working group of the Eurasian

Economic Commission would continue to work with the aim of taking into account all comments from stakeholders. In addition, with respect to the concerns regarding the timelines of expert evaluations, the normal period of expert evaluation in the EAEU was 114 days while the maximum period was 337 days. Such an extension from 114 to 337 days could occur only if a manufacturer or applicant used its right to request a temporary suspension of expert evaluation, for example, in order meet the deadlines for submission of documents. Russia took note of the concerns raised by

interested Members and was ready to continue working with them on the matter.

66 For previous statements follow the thread under IMS ID 520 (under dates raised and references).

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2.3.4.34 Russian Federation, Kazakhstan, Kyrgyz Republic — Pharmaceutical products - Resolution 1314 of the Government of the Russian Federation on determining compliance of medicinal products' manufacturers with the requirements of Good Manufacturing Practice (non-notified); draft decisions of the Board of the Eurasian Economic Union, G/TBT/N/RUS/54, G/TBT/N/RUS/58, G/TBT/N/RUS/63 (IMS ID 52167)

2.185. The representative of the European Union reiterated previously raised concerns and made further requests for information regarding GMP requirements for pharmaceutical products. The full statement is available in G/TBT/W/507.

2.186. The representative of the Russian Federation said that the Russian system of GMP inspection fully complied with international standards and recommendations in this area. The State Institute of Drugs and Good Practices, subordinate to the Ministry of Industry and Trade of the

Russian Federation, was the body authorized to conduct GMP inspections. The inspection schedule for foreign producers was published on the website of the Ministry of Industry and Trade of the Russian Federation and included more than 300 inspections between February and August of this year.

2.3.4.35 Ireland — Public Health (Alcohol) Bill 2015, G/TBT/N/IRL/2 (IMS ID 51668)

2.187. The representative of Mexico reiterated previously raised concerns 69 related primarily to the labelling requirements of the measure, such as the inclusion of health warnings with no

scientific basis, and the setting of minimum prices. Mexico believed that instead of enacting or promoting a measure entailing a trade restriction, the Irish Government could rethink the solution to the problem of alcohol consumption among its population by implementing public health programmes and media campaigns. Her delegation believed that these actions would allow the legitimate objective to be achieved while avoiding restrictive and burdensome labelling requirements, in accordance with Article 2.2 of the TBT Agreement. She stressed the importance

that Ireland take into consideration the positions of the countries affected by this measure,

deemed to be extremely restrictive and in violation of the principles of international trade, as it clearly created an unnecessary barrier to trade. Mexico was aware that this Bill had been approved by the Irish senate in December 2017 and notified again to the EU in early 2018. Consequently, Mexico requested that the EU report on: (i) the status of the measure at the European Commission and its notification to the WTO, and (ii) the time-frame for the public consultation.

The representative of Argentina raised concern about the measure, which amended certain 2.188.

regulations for alcoholic beverages by incorporating additional labelling and marketing specifications, with a view to reducing alcohol consumption to 9.1 litres of pure alcohol per capita. He recalled that once the proposed amendments were adopted, the marketing of alcohol products in the Republic of Ireland would require the use of labels warning of the direct link between alcohol and fatal cancers. In addition, the proposed changes introduced limits to alcohol product advertising, including restrictions on television and in print media and public spaces. Argentina believed that the requirement to display warning messages on the direct link between alcohol

consumption and cancer in a uniform way for beverages with different alcoholic strengths, without distinguishing between abusive and harmful consumption on the one hand and responsible consumption on the other, was disproportionate in relation to the legitimate aim of protecting human health and could cause unnecessary barriers to international trade and serious harm to many production sectors.

He claimed that wine, for example, which was a noble product of low alcoholic strength, 2.189. would undergo stigmatization and loss of image. Warnings, he said, should be aimed at preventing

abusive behaviour by consumers and not merely consumption. Argentina considered that the legitimate objective of reducing alcohol consumption per capita could be achieved without disproportionate labelling requirements, in accordance with Article 2.2 of the TBT Agreement. It could be achieved through campaigns to raise public awareness of the harmful effects of excessive alcohol consumption on health, without negatively affecting such products' image and marketing,

67 For previous statements follow the thread under IMS ID 521 (under dates raised and references). 68 For previous statements follow the thread under IMS ID 516 (under dates raised and references). 69 G/TBT/M/73, para 2.165

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and/or through labelling recommending moderate consumption, so as not to restrict international trade beyond what is necessary to attain the legitimate objective. He stressed that the health imperative should be to end addictive behaviour; excessive alcohol consumption could not be resolved by labelling systems, but rather a change in habits. Argentina therefore requested that Ireland review the Bill, align it with WTO rules and keep Members informed about its entry into force and implementation.

The representative of the United States said that on 10 January 2018 and again on 2.190. 14 February 2018, her delegation had written to the WTO TBT Enquiry Points in the EU and Ireland asking Ireland to notify the amended version of its Public Health (Alcohol) 2015 measure to the WTO TBT Committee. The US deemed notification appropriate because the measure had been substantially amended, such as by a requirement that 30% of a label be covered by health warnings and recalled Committee recommendations for Members to notify substantially re-drafted

measures prior to adoption or entry into force. Ireland's responses indicated that a copy of the

measure would be provided upon enactment. She noted, however, that on 19 January 2018 Ireland had notified the amended bill to the European Commission under its Technical Regulation Information System (TRIS) procedure, providing the Commission and member States a three-month comment period. She explained that all WTO Members should have an opportunity to comment on the same basis as afforded to other EU members, as other Member were no less impacted. She stated that the bill, if enacted, would impact US trade – and that of other WTO

Members – by requiring exporters to produce Ireland-specific labels, impacting their ability to reallocate product in the European market. The US therefore reiterated its request for Ireland to notify the amended bill in order to give trading partners the opportunity to comment before finalization.

The representative of Chile echoed the concerns raised by other Members regarding 2.191. minimum pricing and labelling.

The representative of New Zealand acknowledged and supported Ireland's right to 2.192.

introduce new regulations to address specific public health concerns, namely the harmful use of alcohol, but shared other Members' concerns that the additional specifications to labelling requirements proposed were more burdensome than necessary to achieve a legitimate regulatory objective. New Zealand requested an update on when the amendments to the bill would be notified to the TBT Committee.

The representative of Guatemala expressed its interest and systemic concern regarding the 2.193.

measure and requested information on the internal EU process relating to the Irish regulation.

The representative of the European Union responded to the concerns raised. The full 2.194. statement is contained in G/TBT/W/508.

2.3.4.36 China — Cybersecurity Law (IMS ID 52670)

The representative of the United States reiterated concerns raised during the previous 2.195. Committee meeting.71 Her delegation stated that other Members had rules to ensure security of critical infrastructure, but did so without stifling international competition. The fact that China was

now expanding the Multi-Level Protection Scheme (MLPS) to include a wide array of commercial sectors that did not constitute critical infrastructure raised further concerns. The US requested further clarification as to the linkage between MLPS and the Cybersecurity Classified Protection Scheme referenced in the Cybersecurity Law. She noted that the US and other Members had commented on what appeared to be an MLPS-related draft standard, issued by China on 25 January 2018, "Information Security Technology – Guidelines for Grading of Classified Cybersecurity Protection." She asked whether China intended to notify this measure to the TBT

Committee and allow for additional stakeholder comments.

The representative of Japan reiterated her delegation's concern and strong interest with 2.196. regard to the Cybersecurity Law that entered into force on 1 June 2017 and recalled China's statement that it would not require enterprises to use Chinese technology or domestic products

70 For previous statements follow the thread under IMS ID 526 (under dates raised and references). 71 G/TBT/M/73, paras. 2.184-2.186.

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and to hand in their source code to the government. Her delegation asked whether or not China had issued any guidelines or regulations based on this law, which prescribed the clear explanation of terms "secure and controllable" or "secure and trustworthy", as had been requested by Japan. If these definitions had not been stipulated, China was again requested to expressly provide the definition of these terms in the law or regulations in order to enhance transparency and predictability of the law. In addition, as Japan and other Members repeatedly requested, Japan

asked China to clarify definitions, requirements and scope of national standards or conformity assessment procedures subject to the law. Japan also hoped that China would implement these measures in a transparent manner.

The representative of the European Union continued to raise concerns regarding the new 2.197. Cybersecurity Law. The full statement is contained in G/TBT/W/509.

The representative of the Republic of Korea expressed his delegation's support for the 2.198.

comments made by previous delegations and reiterated its statement expressed in the previous Committee meeting in particular with regard to the comments made on Article 35, 24, and 58 of the law.

The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and 2.199. Matsu stated that certain articles, in particular Articles 22, 23, 35 and 37, in the Cybersecurity Law might create unnecessary obstacles to trade for information service providers or product suppliers of other WTO Members due to the lack of clarity of methods, definition, and application scope in its

implementation. Besides, it was not clear how the technical specifications would be applied, such as whether the source codes were required to be provided in the product inspection procedures, what would be considered as "critical" in its information infrastructure, etc. Given the issue was technically complex and would cause potential technical trade barriers to market access, his delegations requested China to undertake thorough discussion in order to enhance its transparency and predictability.

The representative of Australia supported the concerns raised by other Members and 2.200.

reiterated concerns raised during the previous Committee meeting.72

The representative of China said that opening-up was the basic policy of China, that is, 2.201. China's door was always open: this was also the principle of China's cyber security policy. The purpose of this law was to ensure the cyber space sovereignty and national security, to safeguard the public interests, rights and interests of citizens, legal persons and other organizations in China. There was therefore no intention of restricting the market access of foreign enterprises,

technologies in China. At present, the relevant authorities were drafting the follow-up rules and regulations in accordance with the requirements in Cyber security law. Some were already completed, while some others were still in the preparatory process. After the release of the Law, more than 30 meetings for information exchange, consultation, and introduction were held, and in the meantime, the follow-up polices, standards were also open for comments. Regarding the definition of "secure and controllable", China again made the following clarifications. Firstly, data was controllable for the users. The product or service providers were not to use their product or

service to illegally obtain users' data. Secondly, equipment was controllable for the users. Providers were not to illegally control users' equipment. Thirdly, to guarantee that users had choices, providers were not to operate a monopoly or seek illegal interest by making use of users' reliance on the product or service, such as stopping providing safety technical support without a justifiable reason or force users to upgrade. As regards certain terms, China explained that these terms were not created by China. There was no distinction between domestic and foreign

companies as all enterprises had to abide by these requirements. She also stated that China

attached great value to IP and its effective protection. China was therefore against any behaviours

that would impair the IP of enterprises. China would not therefore require enterprises to hand in their source code to the government.

72 G/TBT/M/73, paras. 2.192.

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2.3.4.37 China — Tentative Administrative Rules on Enterprises Average Fuel Consumption and New Energy Vehicle Credits and Administration Regulation on the Access of New Energy Vehicle Manufactures and Products, G/TBT/N/CHN/1187, G/TBT/N/CHN/1188 (IMS ID 52773)

The representative of Japan, referring to G/TBT/N/CHN/1187, said that the final 2.202. Administrative Rules published on 28 September 2017 were still of concern to the Japanese

automotive industry. In particular, Japan recognized that China had not announced the quota for the new energy vehicle (NEV) production after 2021. Japan requested China to allow sufficient time and opportunities to discuss with other Members when China established the requirements for 2021. Japan appreciated that the final rules reflected not only the Chinese market trends, government subsidy, the production capacity of each automobile company and the development of EV charging infrastructure, but also the comments from other members, including the comments

of Japan. Meanwhile, this Administrative rules imposed production of NEVs on the companies.

Japan sincerely requested China to carefully consider supply and demand balance when implementing the Administrative rules.

The representative of the United States said that the principal issue related to China's 2.203. initial draft was the short timeframe allowed for compliance. The final rules addressed compliance for the years 2019 and 2020. China had indicated plans to update these rules for 2021 and following years. However, details had not been made public. The US requested China to make

public its plans for these future credits or postpone further changes to reasonable lead-time that would take into account the time typically needed by automakers for vehicle development and production cycles, which was roughly four to five years. The US official response to G/TBT/N/CHN/1187 was a request for a three-year delay in implementing the measure to take into account new motor vehicle development and production cycles. The delegation stressed that the US was well below any of those thresholds and asked China to share any further details on these plans.

The representative of the European Union supported the concerns raised by other 2.204. delegations and welcomed the improvements introduced by China published in September 2017. The full statement is contained in G/TBT/W/510.

The representative of China said that in order to relieve the pressure on energy and 2.205. environment and to improve the energy conservation of passenger vehicles, the Parallel Administration Rules on Average Fuel Consumption and New Energy Vehicle Credits of Passenger

Vehicle Corporate (Parallel Administration Rules) had been released on 27 September 2017 and would enter into force on 1 April 2018. She explained that the Parallel Administration Rules adopted a parallel administration mechanism of two types of credits, namely average fuel consumption credits and NEV credits, in line with the current stage of development of the automobile industry in China. This administration mechanism took into account not only the improvement of energy conversation of traditional automobiles but also the innovative development of NEVs. The rules aimed at establishing a market-oriented, long-term mechanism to

promote the development of the energy-saving and NEV industries. She stated that the fulfilment

of a certain proportion of NEV credits would not be required until 2019 to allow automobile enterprises time for R&D for products and production layout. This requirement solicited comments from all parties both domestically and abroad, bearing in mind the current situation of the automobile industry. She further explained that the Parallel Administration Rules insisted on treating domestic and foreign enterprises equally. Since their release, major automobile manufacturers had expressed their support for the rules and had actively conducted R&D and

production layout of energy-saving and NEVs. They made efforts to improve energy conservation of automobiles and vigorously develop new energy vehicles to meet the requirements of the Parallel Administration Rules.

China also stated that the Administration Regulation on the Access of New Energy Vehicle 2.206. Manufactures and Products (Administration Regulation) had been released on 6 January 2017 and entered into force on 1 July 2017 to protect public life and property, improve the safety

performance of NEVs, and promote industrial development. The Administration Regulation required NEV manufacturers to comprehend and master the development and manufacturing technologies

73 For previous statements follow the thread under IMS ID 527 (under dates raised and references).

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of the NEVs they produced, which was the basic requirement of ensuring production consistency as well as the safety and quality of NEV products. Her delegation noted that the regulation was non-discriminatory and applied to all NEV manufacturers in China and that there was no mandatory technology transfer for foreign-invested enterprises.

2.3.4.38 European Union — Radio Equipment Directive, G/TBT/N/EU/93 (IMS ID 52574)

2.207. The representative of China said that on 22 May 2014, the European Union had issued a

new version of the radio equipment directive (RED), 2014/53/EU, in its official journal based on the new CE legislative framework (Regulation No EC 765/2008 and Decision No 768/2008/EC). China noted that the purpose of the new legislative framework was to ensure product safety in the EU market by strictly enforcing CE marking requirements. The new RED directive would replace the original radio equipment directive R&TTE 1999/5/EC.

China further noted that on 13 June 2016, the old R&TTE directive 1999/5/EC was 2.208.

repealed and products that were evaluated under the old directive were able to be sold until 13 June 2017. After 13 June 2017, only wireless devices that were evaluated in accordance with the new RED 2014/53/EU were allowed to be sold in the EU market, China said. However, China explained that it was not until 13 October 2017 that the EU had released its own list of the latest harmonized standards in compliance with directive 2014/53/EU in its official journal. China said this had caused great challenges for manufacturers seeking product certification. Although the EU had released a list of harmonized standards, the release time of product standards lagged far

behind the export demand for 5G equipment. China noted that the EU telecommunications operators testing bureau needed to import a large amount 5G equipment, however, due to the lack of corresponding certification standards it was difficult for Chinese companies to send products to the EU, and the certification process was costly and uncertain. China explained that testing bureaus often needed the equipment to last for one to two years, and therefore it was not possible to send test equipment, since customs authorities required test equipment to be returned every six months.

While the EU considered the harmonized standards as voluntary, China noted that 2.209. according to the Article 5.1 of the RED guide "the application of harmonized standards has the advantage of giving presumption of conformity with the corresponding essential requirements that they aim to cover." China said that this appeared to recognize the harmonized standards as mandatory. According to the RED guide, if a manufacturer chose not to follow a harmonized standard or only partly, there was an obligation to prove that the radio equipment was in

conformity with the essential requirements by other means and to provide a full technical justification. This could lead to high costs and long delays in certification if harmonized standards were not yet adopted.

First, China asked whether the EU had a plan to pass the 5G equipment certification 2.210. standards as soon as possible, to protect the smooth market requirements of the testing bureau; or to consider 5G equipment as specific equipment, and cancel the requirement that the corresponding test equipment must be returned every six months. Second, China requested

clarification from the EU as to the potential mandatory feature of the voluntary harmonized standards.

The representative of the European Union responded to the concerns raised. The full 2.211. statement is contained in G/TBT/W/511.

2.3.4.39 European Union — Organic production and labelling - Maté (erva-mate) (IMS ID 52475)

2.212. The representative of Brazil thanked the EU for addressing their concerns and for including

erva mate in the list of organic products in the final version of the normative COM/2014/180. Brazil was also pleased to hear about the conclusion of the talks among the Parliament, the Commission and the Council, paving the way for the adoption of the normative. He asked when the legislation would finally be adopted and whether there were any specific transition provisions

74 For previous statements follow the thread under IMS ID 525 (under dates raised and references). 75 For previous statements follow the thread under IMS ID 524 (under dates raised and references).

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that could apply to erva mate before the new legislation entered into force. If this was not the case, he wondered whether the EU would be open to establishing a working group or bilateral dialogue to address an interim solution to address this issue.

2.213. The representative of the European Union responded to the concerns raised. The full statement is contained in G/TBT/W/512.

2.3.4.40 China — Cyberspace Administration of China – Draft implementing measures

for the Cybersecurity Review of Network Products and Services (IMS ID 53376)

The representative of the Republic of Korea said that Article 3 of the draft implementing 2.214. measures required a security screening assessment by a third party organization. Her delegation considered that this could lead to an infringement of intellectual property, given the absence of a clause protecting intellectual property in case of certification by third party institutions. Korea

therefore requested that China add such a clause to this article to prevent leaks of confidential

business information. Korea also requested clarification of the scope and procedure of the cooperation of network security evaluation outlined in Article 12 which, in her delegation's view, were not specifically or clearly defined and could potentially lead the government to demand companies excessive disclosure of technical information.

The representatives of the United States and Japan reiterated previously raised 2.215. concerns.77

The representative of the European Union continued to raise concerns regarding China's 2.216.

cybersecurity review of network products and services. The full statement is contained in G/TBT/W/513.

The representative of China reiterated the response provided at the previous Committee 2.217. meeting.78 It is common practice internationally to improve secure and controllable level of

network products and services to safeguard the cyber security. Many members have adopted the similar reviews. Cybersecurity Review of Network Product and Services is to improve the secure and controllable level and prevent the security risk, safeguarding the national security and public

interests. It is not targeted at specific member, makes no difference between members, and will not discriminate against products and technologies from abroad, nor will it restrict the market access of foreign technologies. Besides, China thinks high of IP and effectively protects it, being against all the behaviors impairing the IP of enterprises. China won’t require the enterprises to hand in their source code to the government.

2.3.4.41 China — Draft revised Encryption Law of the People's Republic of China by the

Office of State Commercial Cryptography Administration (OSCCA) (IMS ID 534)

2.218. The representative of Japan repeated concerns raised at the previous Committee meeting.79

The representative of the European Union continued to raise concerns regarding China's 2.219. Draft revised Encryption Law by the Office of State Commercial Cryptography Administration (OSCCA). The full statement is contained in G/TBT/W/514.

The representative of the United States remained concerned by what seemed to be a wide-2.220.

spread effort by China to impose "secure and controllable" requirements, largely based on the Multi-Level Protection Scheme (MLPS) system, on ICT products. The United States said that the MLPS was inflexibly prescriptive and could restrict the ability of consumers to purchase technologies established as safe everywhere else in the world. Additionally, in the view of the United States, the requirements raised national treatment concerns by mandating domestic IP and equipment usage in sectors deemed "critical". This was of particular concern given the extensive scope of projects classified as level 3 or above. The United States hoped that China would take

76 For previous statements follow the thread under IMS ID 533 (under dates raised and references). 77 G/TBT/M/73, para. 2.222 and G/TBT/M/73, para. 2.223, respectively. 78 G/TBT/M/73, para 2.220. 79 G/TBT/M/73, para. 2.216.

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into account all stakeholder comments made on the draft standards related to MLPS, but more broadly, encouraged China to adopt international standards instead of creating country-specific ones.

The representative of the Republic of Korea reiterated previously raised concerns.80 2.221.

The representative of China repeated its response to the concerns raised provided at the 2.222. previous Committee meeting.81

2.3.4.42 European Union — Regulation (EC) No 1107/2009 - non-renewal of approval of the active substance picoxystrobin G/TBT/N/EU/437 (IMS ID 53582)

2.223. The representative of Brazil expressed concern about the EU ban on certain substances founded only on a hazard-based approach. In Brazil's view, the withdrawal of picoxystrobin from

the list of substances approved by Regulation 540/2011, thus suspending, since November 2017, the authorizations of pharmaceutical products containing this substance, did not take into account

the international standards and scientific consensus on the subject, which considered the substance to be safe in order to protect crops, particularly regarding genotoxicity.

Brazil highlighted the following scientific consensus on the matter: Council Directive 2.224. 91/414/EEC declared picoxystrobin to be non-toxic; the report of the European Food Safe Authority highlighted that "it was not possible to conclude on the genotoxicity potential of picoxystrobin based on the available data"; the recommendations of the Joint Committee on pesticides residues specialists of the FAO-WHO concluding that this substance was not genotoxic;

the fact that agencies in almost 70 countries had approved the use of this substance, including the US Environmental Protection Agency (EPA), the Canadian Pest Management Regulatory Agency, the Japanese MAAF Agency, among others; and European authorities such as the Standing Committee on Plants Animals, Food and Feed and the appeal committee had not found a conclusive decision on this ("no opinion").

In this sense, the Brazilian delegation asked EU to consider that, depending on possible 2.225. reductions on MRL for this substance, Brazil might face serious impacts on trade for certain

agriculture commodities. Brazil requested the EU to take its concerns into account in compliance with Articles 2.2 and 2.5 of TBT Agreement so as to not create unnecessary restrictions to trade and to declare picoxystrobin as safe for the protection of crops and renew the licensing of products treated with the substance.

The representative of Canada said that picoxystrobin was an active ingredient that was 2.226. used as a fungicide on a wide variety of crops cultivated in Canada and exported to the European

Union. Canada understood that no changes to existing MRLs had been proposed at this time. However, Canada was aware of recent SCOPAFF discussions in February 2018 on future work on MRLs for picoxystrobin. Canada requested that any change to the import MRL be notified to the WTO SPS Committee.

Canada said that in light of the reviews undertaken internationally that had determined 2.227. that this active ingredient could be used safely in agriculture, Canada sought confirmation from the EU that import MRLs for the active ingredient would be maintained in order to avoid unwarranted

trade disruptions. Canada sought confirmation from the EU that import MRLs for this active ingredient would be maintained in order to minimize trade disruptions. If not, Canada sought confirmation from the EU that any proposal for changes to existing MRLs would be notified to the SPS Committee, and that SPS Committee Members would have the opportunity to provide comments to the EU. In addition, Canada encouraged the EU to base its scientific review process on the assessment of risks and to consider all data that was made available for the purpose of a review.

80 G/TBT/M/73, para. 2.218. 81 G/TBT/M/73, para. 2.220. 82 For previous statements follow the thread under IMS ID 535 (under dates raised and references).

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The representative of the European Union recalled that detailed written information had 2.228. been provided, in response to Brazil, on this issue on 19 July 2017. A number of points were made at the current meeting. The full statement is contained in document G/TBT/W/515.

2.3.4.43 European Union — Titanium dioxide: Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 (IMS ID 53983)

2.229. The representative of the United States expressed continued concern with the

transparency and pace of the EU's process to classify Titanium Dioxide. As reflected in the public comments by the member States, the study proposed by the Commission-supported EU Nanosafety cluster on TiO2 classification, as well as ongoing consultations by the EC on the classification and risk of nanoforms, including poorly soluble, low toxicity (PSLT) substances such as TiO2, there was not yet scientific consensus. Given the potential trade impacts on this $20 billion dollar TiO2 global industry, as well as the over $80 billion in trade of downstream products

using the substance, her delegation asked that the EU avoid premature action. The TiO2 carcinogen classification and the resulting labelling and risk management requirements it would set in place may also be precedential for a number of other substances, similarly available as nano-particles and therefore potentially subject to the same requirements. This would exponentially multiply the trade impacts on a number of products.

2.230. The US was of the understanding that the Commission was planning a technical consultation in April to review the question of how to best classify and to manage the risk of TiO2.

The US welcomed the EU's invitation to submit comments on the meeting and its agenda, but asked that, in line with transparency commitments under the TBT Agreement, the EU open the meeting to the US and other stakeholders. She said that there was good precedent for US–EU collaboration in addressing the potential trade impacts of chemical evaluations and classifications, as exhibited in 2017, when the EU had hosted a bilateral specialist consultation on textiles. Her delegation believed that a similar exchange would be an excellent means of ensuring that international stakeholder input was received and reviewed.

2.231. The representative of the European Union responded to the concerns raised. The full statement is contained in G/TBT/W/516.

2.3.4.44 China — Catalogue of Solid Wastes Forbidden to Import into China G/TBT/N/CHN/1211 (IMS ID 54584)

The representative of Japan asked that the concerns raised by his delegation under the 2.232. STC No. 1 also be considered under this STC.85

The representative of the United States reiterated previously raised concerns 86 over the 2.233. negative trade and environmental impacts resulting from China's import ban restricting imports of recovered materials, such as plastics. The representative noted that despite the concerns and the US delegation's repeated attempts to request meetings with experts from China's Ministry of the Environment to discuss these concerns, China appeared to be moving forward with the

implementation of these trade-restrictive measures. The US requested China to immediately halt implementation of its ban on the import of recovered materials in favour of a less trade-restrictive

approach. The representative of the United States requested China to provide a 60-day comment period in line with the Committee Recommendations contained in Annex 3 of G/TBT/9 and allow reasonable implementation timeframes subsequently. Similar to China's import standards, the notifications G/TBT/N/CHN/1211 and G/TBT/N/CHN/1212 had entered into force well before the customary six-month minimum timeframe for technical measures and beyond any reasonable interval for industry to make necessary adjustments to their supply chains.

The US welcomed China's interest in addressing environmental concerns but, at the same 2.234.

time, stressed that the approach taken would have the opposite effect by exacerbating both global

83 For previous statements follow the thread under IMS ID 539 (under dates raised and references). 84 For previous statements follow the thread under IMS ID 545 (under dates raised and references). 85 China — Chinese Environmental protection control standards for imported solid waste as raw

materials (paras. 2.9-2.19 above) 86 G/TBT/M/73, paras 2.8-2.9.

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and local environmental challenges. Most likely reusable plastics would be redirected from productive purposes to the waste stream posing harm to fish and wildlife. The US delegation expressed concerns about the scope of materials subject to the import ban. Meanwhile, the US believed that China had no commensurate domestic materials management regime in place and was interested in learning about China's views on G/TBT/N/CHN/1211 in the context of national treatment requirements. Similar concerns were expressed about China's import control standards.

Further, the US was concerned that a ban with such a broad scope was more trade-restrictive than necessary to fulfil its objectives. Had China considered less trade-restrictive alternatives instead of a total ban? If not, the US would be pleased to work with China on such less trade-restrictive alternatives. The US enquired about the measures China was applying to the use or sale of domestically sourced recovered materials, and asked if those measures might not suffice if applied to imported materials as well. Given these standards had not been notified to the WTO TBT

Committee and only provided a 15-day public comment period, the US requested China to notify these new standards in a timely manner and provide a 60-90 day comment period. The US called

for the measure to be halted with a view towards developing alternative less trade-restrictive measures.

The representative of Australia supported China's efforts to reduce pollution through a 2.235. broad range of measures but shared the concerns of other delegations about the ban on certain waste and scrap imports. The ban on imports would affect Australian exporters and could lead to

large amounts of waste going to landfill, instead of being recycled in China and recovered for intermediate materials. The representative queried the regulations or standards applied to domestic waste products and how they were to be enforced, and whether domestic waste standards were the same as the ones applied to foreign waste. Australia sought further information on the specific public health and environmental protection objectives and their fulfilment by the measure, and any technical and scientific analysis underpinning the measure. Australia also questioned whether the measure was more trade restrictive than necessary to

achieve the desired objectives. Like other Members, Australia was also concerned about the insufficient timeframe for comments on the measure. The representative urged China to withdraw

the measure, and consider all possible mechanisms to meet its environmental objectives and reduce hazardous waste, while not disrupting valuable trade in recyclable materials.

The representative of New Zealand recalled that WTO Members retained the right to 2.236. regulate to protect their environments. However, New Zealand believed that it was vital to the

continued effective functioning of the WTO rules-based system that all WTO Members adhered to the agreed TBT Committee procedures relating to the notification of new measures. In that respect, New Zealand echoed the points raised by other Members in relation to the short comment timeframe and implementation period.

Concerning the impact of China's new measure on imports of vanadium slag specifically, 2.237. New Zealand sought clarification about the way the measure was being applied to domestically produced vanadium slag purposefully produced as a co-product to the manufacture of iron and

steel. Specifically, how would China ensure that the conditions for foreign products were no less favourable than those accorded to domestic products? The representative noted that for vanadium

slag, China was one of the largest global producers, with approximately 500,000 tonnes annual production generated as a co-product from a number of steel mills. In light of this, New Zealand was interested in China's clarification on how an import under 50,000 tonnes of vanadium slag, and non-application to significantly larger domestic production or processing, would achieve China's environmental and health objectives. New Zealand was also interested to receive a further

explanation on how it had ensured that the import ban was not more trade restrictive than necessary to achieve China's environmental and health protection objectives. New Zealand further asked whether China had considered less trade-restrictive alternatives that would apply equally to domestic and foreign vanadium slag to achieve its environmental protection objectives, and, if so, on what basis it had been decided not to adopt such alternatives.

The representative of Canada shared the concerns raised by other Members about the 2.238.

uncertainty that China's restrictions on the import of solid waste were creating for traders. Clarity on the explicit descriptions of each newly banned materials and the rationale for China's action in each case would be most helpful in understanding China's intentions. In particular, Canada

requested specific details on how China would differentiate between the products listed under HS code 3915 that appear on both the Catalogue of Solid Wastes Forbidden to Import into China and the Catalogue of Solid Wastes Which were Restricted to Import and Usable as Raw Materials.

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The trade in recyclable materials between Canada and China was mutually beneficial. 2.239. Canada encouraged China to consider all possible mechanisms that would achieve their environmental objective, while ensuring that trade is not disrupted.

The representative of China said advancing the reform of the solid waste import 2.240. administration regime is one of the most important steps that the Chinese Government has taken to implement the New Development Ideas, safeguard the eco-environment safety and population

health. China had allowed a sufficient transition period for adjustment by delaying the effective date of the new catalogue to 31 December 2017, leaving a six-month transition period for relevant industries and enterprises. China believed that most importantly, all Members, not only China, but also the rest of the world should follow the letters and spirit of the Basel Convention, to reduce, process, and recycle hazardous wastes and other wastes produced within their own territory. With this consensus and subject to this condition, many problems could be better solved, and mutual

understanding could be developed. It would also contribute to the global promotion of a green,

low-carbon and recycling development mode, and the creation of a clean, beautiful world.

2.3.4.45 India — Amended regulation on toy imports – G/TBT/N/IND/68 (IMS ID 54687)

2.241. The representative of the European Union continued to raise concerns regarding India's amended Toy Imports Regulation. The full statement is contained in G/TBT/W/517.

The representative of the United States supported India's goal of ensuring toy safety. 2.242.

However, the US had serious concerns with the burdensome nature of these new requirements, which could harm the US toy industry's ability to access the Indian market. Prior to the regulatory changes, India employed what many consider the "gold standard" of toy regulatory regimes: toy manufacturers could test to either the ASTM, ISO, or EN toy safety standards in the country of manufacture by a lab accredited under the ILAC system. She noted that, while India noted that the rationale for the regulatory changes was a concern about the quality of products coming in from a

particular country, the measure was affecting all imports, regardless of the country of origin.

According to India's recent trade statistics, India imported toys from 48 different countries in 2016. The US was the sixth largest exporter of toys to India in 2016. These were primarily specialty toys from small and medium-sized manufacturers. The US was also home to two of the world's largest toy companies. The value of the Indian toy market for those companies was estimated at US$75-100 million in 2016. The US requested India for detailed information on the safety concerns of imported toys that lead to the new standard and in-country testing

requirements that was immediately implemented per India's notice to the WTO in December 2017. India was asked to explain whether the same standards, testing, and certification requirements were being equally applied to domestically produced toys because, according to the Amendment, it appeared that only imports must comply with the new changes. Could India provide the US with a list of the foreign labs located outside of India accredited by the National Accreditation Board and Calibration Laboratories (NABL) for testing the safety of toys. This list should also include information on how many applications had been received from foreign labs outside of India to test

for safety of toys versus approved by NABL.

The representative of China noted that the amended regulation required the imported toy 2.243. to be in conformity with only Indian Standards, not international standards, nor EU, US standards which were accepted before. On the other hand, the new regulation required that the imported toys had to be tested by NABL, instead of labs accredited under ILAC MRA. These requirements caused higher costs and new arrangements for the toy enterprises in China, therefore, creating barriers to trade. China hoped that India could make modifications to this measure so as to allow

imported toys to be in compliance with international, EU, US standards, and tested by ILAC MRA labs for imports. China also hoped that India could make an early notification and provide for a transitional period for future amendments of the regulations.

The representative of the Hong Kong, China raised concerns on India's amended Toy 2.244. Imports Regulation. The full statement is contained in G/TBT/W/527.

87 For previous statements follow the thread under IMS ID 546 (under dates raised and references).

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The representative of Mexico supported the concerns raised by previous Members and 2.245. referred to her delegation's position and points in the previous Committee meeting88

The representative of Canada supported the concerns raised by previous Members and 2.246. referred to his delegation's statement in the previous Committee89 meeting

The representative of India recalled the explanations made in the previous meeting about 2.247. the reasons that had led India to enact the measure. He also said that, for Members raising any

additional concern, they should provide them to his delegation so that they could be sent to capital for any further clarification on the issues. The concerns already raised by Hong Kong, China would soon be replied to.

2.3.4.46 China — Certification requirements for processed foods G/TBT/N/CHN/1209 (IMS ID 54790)

2.248. The representative of the United States thanked China for its bilateral engagement to date

on the concerns raised on the proposed official certification requirements for imported foods and also for its September 2017 announcement notifying WTO Members of the two-year transitional period for enforcement from 1 October 2017 until 30 September 2019. The US remained concerned that, first, the scope of the products covered by the measure appeared to include processed, shelf-stable foods that ordinarily posed little food safety risk. Second, China had not provided a scientific rationale for the requirement or evidence that official certification would address an identified concern. Third, the requirements raised questions as to the consistency with

Codex principles and guidelines, particularly with respect to the basic principle of basing national control systems, including import requirements, on evidence and risk. Fourth, the US noted that national treatment questions as the requirement applied only to imports without a corresponding requirement for domestic production. China had indicated its willingness to consider and adopt reasonable suggestions from trading partners to modify the proposed measure. To that end, the US respectfully requested that China revise its measure to ensure consistency with international

guidelines and address the concerns expressed by trading partners. The US also requested that

China notify its revised draft measure to the WTO SPS Committee, given that its stated purpose was to address food safety concerns, concurrently with the TBT Committee, for Members' review and comments. The new draft needed to identify the risk to be mitigated by the certification requirement and clarify the scope of products subject to the proposed measure. The US looked forward to continued engagement with China in order to reach a mutual agreement on reasonable requirements for food imports

The representative of the European Union continued to raise concerns regarding China's 2.249. certification requirements for processed foods. The full statement is contained in G/TBT/W/518.

The representative of Japan shared concerns raised by the United States and the European 2.250. Union. Japan welcomed the provision of a two-year transitional period. Japan recognized that China was in the process of taking into account comments received at various occasions and was considering the new measure. Japan requested China to provide timely updates and appropriately

include responses to the comments provided.

The representative of Guatemala thanked the US and the EU for including the issue on the 2.251. agenda and China for modifying the date of entry into force of the measure to October 2019, providing industry with time to adapt to the new measures. However, Guatemala also called on China to provide written replies to the request they had submitted on 4 August 2017 regarding the status of the measure. Guatemala thanked China for their willingness to engage in consultations.

The representative of China, recalling explanations provided during previous meetings, 2.252. said that the Measures for the Administration of Certificates Attached to Foods Exported to China

had been established based on the Food Safety Law, which required imported food and food additives to be accompanied with a quality certificate, as required by state entry-exit inspection

88 G/TBT/M/73, para 2.21. 89 G/TBT/M/73,para 2.22. 90 For previous statements follow the thread under IMS ID 547 (under dates raised and references).

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and quarantine administration, to certify that relevant food had been produced, processed, stored and exported under the supervision of the competent authority of the exporting country / region and to ensure the effective traceability of the product. The Measures had been officially notified to the WTO in June 2017. After considering comments from interested Members, China had decided to provide a transitional period of two years for all Members and had notified the WTO accordingly. The date of enforcement had been postponed to 1 October 2019. China was willing to consider all

reasonable comments from WTO Members and adjust the measure to make it more effective, practical and to minimize its negative effects on trade. The two-year transitional period was the best proof that China took into account the practical situations of other Members. China welcomed that interested parties keep in touch with Chinese competent authorities and continue discussions on technical details.

2.3.4.47 Viet Nam — Decree on the regulation on conditions for automobiles

manufacturing, assembling importing and automotive warranty & maintenance services

(IMS ID 54991)

2.253. The representative of the Thailand continued to raise concerns regarding Viet Nam's automobile measure. The full statement is contained in G/TBT/W/523.

2.254. The representative of Japan noted that the decree was notified to the WTO only after its entry into force and no comment period was provided. Since its entry into force on 1 January 2018, Decree 116 had caused serious damage in exporting automobiles to Viet Nam. Automobile

importers were required to provide the copy of quality certificate of automobile types issued by overseas authorized agencies. Such a requirement could not be found globally. Domestic automobiles are required to obtain only vehicle type approval issued by Vietnamese authority, and Japan requested the same treatment be granted to imported automobiles. She also noted that the requirement for inspections and tests of each shipment could create unfair conditions for imported automobiles as compared to domestic automobiles. Japan thus requested Viet Nam to treat imported automobiles and domestic automobiles in an equitable manner and that Viet Nam ensure

that the measure was not more trade-restrictive than necessary to fulfil a legitimate objective as o required under the TBT Agreement.

The representative of the United States supported the comment made by previous. Her 2.255. delegation was particularly concerned with the Vehicle Type Approval (VTA) certificate and lot-by-lot testing requirements. In addition, the lot-by-lot testing requirements did not apply to domestically produced vehicles, resulting in discriminatory treatment for imports. The US asked

that Viet Nam accept US-compliant vehicles and US-documentation to meet the VTA requirement. The US also asked that imported firms be allowed the same certification period offered to locally produced vehicles instead of requiring lot-by-lot safety and emissions testing. US auto manufacturers were unable to comply with this Decree and, as a result, imports of US-manufactured vehicles stopped as of 1 January 2018. The US further requested that Viet Nam delay implementation of Decree 116 and its implementing circular so that US auto manufacturers could resume exporting vehicles to Viet Nam, and allow for consultations with the US Government

and industry stakeholders to develop a long-term workable solution. Normally, auto regulations set

out 18-36 months before implementation for manufacturers to meet the new requirements. She asked if Viet Nam would provide an opportunity for industry to comment on the measure after its adoption and why Decree 116 was notified as an emergency measure when similar measures were notified on a continuous basis by WTO Members. The US requested that Viet Nam notify the implementing circular for Decree 116, Circular 3. This was important since Circular 3 laid out conformity assessment procedures, including mandatory certification.

The representative of the European Union continued to raise concerns regarding Viet 2.256. Nam's automobile measure. The full statement is contained in G/TBT/W/519.

The representative of Viet Nam emphasized that the legitimate public policy objective of 2.257. the measure was to ensure consumers' safety and environment protection. The fundamental principle of non-discrimination between domestic and foreign enterprises had been upheld throughout the measure. Viet Nam took note of all the comments and concerns raised by Members

and would shall duly relay them to relevant authorities for further considerations and responses.

91 For previous statements follow the thread under IMS ID 549 (under dates raised and references).

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2.3.4.48 Viet Nam — Cybersecurity Measures (IMS ID 54492)

The representative of Japan expressed concern and strong interest with regard to Viet 2.258. Nam's draft Cybersecurity Law. Japan recognized that Viet Nam had revised the draft law, but it still included various provisions, which could hinder participation of foreign companies in the Vietnamese market. Japan asked that Viet Nam implement the measure in line with the TBT Agreement. Regarding the term "cybersecurity condition", Japan was aware that the Vietnamese

government would provide the definition of the "cybersecurity condition" under Article 13 of the draft law. Japan requested that Viet Nam clarify its requirements and procedures and avoid hindering participation of foreign companies in the Vietnamese market. Japan called on Viet Nam to consider comments from Japan and other Members and implement the draft law in a transparent manner to avoid it being more trade-restrictive than necessary.

The representative of the United States supported the comments made by Japan. The US 2.259.

was encouraged by Viet Nam's willingness to work with the US and other stakeholders to resolve concerns with the Draft Law on Cybersecurity. The US encouraged Vietnam, in revising its draft law, to consider a risk-based approach to cybersecurity drawing from global cybersecurity industry best practices, widely accepted definitions, and international standards. The US understood that Viet Nam was working on the 15th version of the measure and that it was looking at international standards. While there were various conformity assessment schemes, the most important was the Common Criteria Recognition Arrangement (CCRA), which covered the protection of cybersecurity.

The US requested that Viet Nam consider CCRA when revising the latest draft of the measure. By taking into account international best practices for cybersecurity and international conformity assessment schemes, Viet Nam would be able to further improve its business climate and gain the confidence of US ICT manufacturers. The US hoped that the comments they had submitted on the 15th version of the draft would be reflected in future drafts. The US also looked forward to the formal notification and comment period for the draft law and asked Viet Nam to include any implementing measures, as the law covered many different areas.

The representative of the European Union continued to raise concerns regarding Viet 2.260. Nam's cybersecurity measures. The full statement is contained in G/TBT/W/520.

The representative of Viet Nam thanked delegations for their interest in and concerns with 2.261. respect to the draft Cybersecurity Law and also thanked the US for the bilateral meeting. Viet Nam's TBT office was in the process of coordinating with relevant agencies to notify the draft Cybersecurity Law to the WTO. In the meantime, the delegation of Viet Nam had taken note of all

the comments and concerns raised by Members, and would duly relay them to relevant authorities for further consideration and responses.

2.3.4.49 European Union — The establishment and operation of a traceability system for tobacco products, G/TBT/N/EU/505 and G/TBT/N/EU/507(IMS ID 55093)

2.262. The representative of Cuba continued to raise concerns on the EU's establishment and operation of a traceability system for tobacco products. The full statement is contained in

G/TBT/W/470.

The representative of Dominican Republic raised concerns the EU's establishment and 2.263. operation of a traceability system for tobacco products. The full statement is contained in G/TBT/W/524.

The representative of Indonesia said that the concerns raised by Cuba and Dominican 2.264. Republic were of particular interest to Indonesia. Her delegation would closely monitor developments and discussion on this issue. Indonesia reserved its right to come back to this at upcoming TBT Committee meetings.

The representative of the European Union responded to the concerns raised. The full 2.265. statement is contained in G/TBT/W/521.

92 For previous statements follow the thread under IMS ID 544 (under dates raised and references). 93 For previous statements follow the thread under IMS ID 550 (under dates raised and references).

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2.3.4.50 Ecuador — Household refrigerating appliances (RTE INEN No. 009) G/TBT/N/ECU/3/Add.5 (IMS ID 54894)

2.266. The representative of Colombia continued to raise concerns regarding Ecuador's measure on household refrigerating appliances. The full statement is contained in G/TBT/W/466.

The representative of Ecuador thanked Colombia for their interest in this draft regulation 2.267. which had originally been notified in G/TBT/N/ECU/3/Add.1 on 29 November 2005. Ecuador, as a

signatory to the Montreal Protocol on Substances That Deplete the Ozone Layer of 1987, has determined the need to have technical regulations for the use of more environmentally friendly refrigerating substances. In the market of home refrigeration appliances there is an established industry of products that use refrigerating substances with zero Ozone-Depletion Potential (zero-ODP) and low Global Warming Potential (low-GWP). In order to respond to the comments received, Ecuador prepared a first review of Technical Regulation INEN 009 - Household refrigerating

appliances, which, once entered into force, would effectively change the implementation period. As a result, the text of the regulation would enter into force 365 days after its publication in the official journal.

2.4 Exchange of Experiences

2.4.1 Eighth Triennial Review – Chairman’s report (JOB/TBT/240/Rev.2)

The Chair thanked Members for their productive engagement during the informal meeting 2.268. of 21 March during which eight proposals were discussed. He welcomed the important step forward

this represented in the Eighth Triennial Review process. Brazil, Canada, China, the EU and the US made comments on the revised Chairman's report on these discussions, all of which were taken into account in the final report subsequently issued as JOB/TBT/240/Rev.2. The Chairman encouraged the submission of any further proposals in advance of the deadline of 1 June 2018 to allow sufficient time for reflection in advance of the regular June meeting. He also called upon

Members' continued efforts to bring the Eighth Triennial Review to a successful conclusion by November 2018.

2.4.2 Other matters

2.4.2.1 Good Regulatory Practices (GRP)

The Chairman noted that the Committee had held discussions earlier in the week on the 2.269. topic of the Committee's "Non-Exhaustive List of Voluntary Mechanisms and Related Principles of Good Regulatory Practices (GRP)". He recalled that this work had been ongoing since the Sixth Triennial Review when the Committee had been mandated to identify mechanisms and principles

to help guide Members in a more efficient and effective implementation of the TBT Agreement across the regulatory lifecycle. It had resulted in document JOB/TBT/119/Rev.1, dated 4 December 2014. At that time, in December 2014, there was wide agreement on the substantive

content of the document – but its adoption had been held up because of disagreement on the inclusion (or not) of a disclaimer – and the possible formulation of any such disclaimer. Discussion had thus been held up since 2014 and successive chairpersons had tried to resolve the impasse without success.

The Chairman drew the Committee’s attention to the fact that in the SPS Committee, after 2.270. a similarly long "down" period, delegations had agreed on language for a disclaimer in the context of the adoption of a document entitled “Catalogue of Instruments Available to WTO Members to Manage SPS Issues”.95 In the discussion of the document in informal mode, he said that several viewpoints had been expressed that could be grouped in three areas. First, it was reiterated that there was no need for a disclaimer because the document was illustrative and voluntary in nature and this was most clearly expressed in the very title of the document. A second view was that the

document had evolved since the Committee had last considered it some four years ago and that there were new experiences that could be worth discussing and perhaps injecting. And third, it had

94 For previous statements follow the thread under IMS ID 548 (under dates raised and references). 95 Subsequently circulated as G/SPS/63 on 26 March 2018 (see paras 1 and 2).

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been pointed out that the document remained of value, that a lot of energy had been put into it and that while it certainly could be improved and expanded, it remained a good basis to build on. During the informal, the Chairman recalled, no Member had spoken in favour of a disclaimer and he had therefore asked if Members would be willing to advance on the basis of a document without a disclaimer at the current meeting.

The Chairman suggested that Members begin by discussing the issue of the disclaimer. He 2.271.

noted that the disclaimer at issue is contained on the second page, para 3 of JOB/TBT/119/Rev.1. Could Members accept the document without a disclaimer; this would mean the deletion of the text currently in brackets in para. 3?

The representative of India said that his delegation was awaiting instructions on the issue 2.272. from capital but ensured Members that India saw value in the document.

The representative of China requested more time to consult with relevant agencies back in 2.273.

capital and maintained its formal position, suggesting the issue be left open until the next meeting.

The representative of the Russian Federation joined China and India in requesting more 2.274. time to consult stakeholders on the document.

The representative of Brazil recalled his delegation's position in the informal meeting, 2.275. echoing the Chair's sentiment that as the document had been on the table for quite a while, and as long as there was no fundamental objection to the text of the non-exhaustive list, the Committee could perhaps envisage getting it approved. Brazil continued to share the opinion of others that

the document contained nothing that could or should give rise to concern. The list had been negotiated in the Committee, and, moreover, it complied with what was already in the TBT Agreement. As such, his delegation believed that the list fell under the objectives of the WTO and its bodies, specified in the Marrakesh Agreement, and sometimes repeated in the specific agreements, to “further the objectives” of these agreements.

On the specific issue of the disclaimer, Brazil recognized the hesitation of some Members 2.276. but reiterated his delegation’s stance, and that of many others, that inserting disclaimers created

difficulties and probably also encouraged their proliferation to other committees, particularly when the document simply contained a list. He urged China, India and Russia to reflect on this in order to try and get the document adopted by the June meeting. He recalled that back in early 2013, Members had evaluated and assessed the value of having disclaimers (and different forms thereof); the conclusion had been that there was no legal reason for a legal disclaimer, but that there may be political or other reasons. In addition, there had been two opportunities (in the TBT

and SPS Committees) to hear reports by a representative from the WTO Legal Affairs Division which had not given rise to a different conclusion. Brazil urged the Committee to give meaning to paragraph 29 of the Nairobi declaration which recalled Members' collective responsibility to strengthen the work of regular WTO bodies. It was hoped that by June, the Committee could complete its work on this matter.

The Chairman said that it was too early to take any decision on the issue as some 2.277. Members needed more time. He therefore proposed to revert to the matter in informal mode prior

to the June meeting, by which point, he hoped, positions would be clearer and consultations may have been concluded.

The representative of Argentina agreed with the proposal of the Chairman. However, he 2.278. enquired whether at the proposed informal meeting there would only be discussion of the disclaimer or whether the second point mentioned in his report (the fact that GRP had evolved over the last four years) would be discussed, as it appeared that some Members would have objections to the document beyond the disclaimer.

The representative of the United States expressed concern that the GRP document dated 2.279. from the Sixth Triennial Review and that no Member had proposed that the document be considered under the current Eighth Triennial Review. As such, her delegation suggested that it be

considered on a separate agenda to discussions on the Eighth Triennial Review. In addition, she suggested that it would be 'cleaner' to talk about JOB/TBT/119 for the Sixth Triennial Review as it did not contain the bracketed language that was being discussed at the current meeting.

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The Chairperson, addressing Argentina's question said that if the issue of the disclaimer 2.280. could be addressed and solved, discussions could move forward. However, if no resolution was found, he believed there would no value in discussing the substance of the document. To the United States he confirmed that discussion of the disclaimer was on a separate track from the Eighth Triennial Review and that there was no formal linkage between the two.

The representative of Argentina supported the Chairperson's stance on how discussions on 2.281.

this issue should proceed. He said that his delegation's impression from the informal meeting held earlier in the week was that not many Members objected to whether or not to include disclaimer, and as such there was no need for lengthy debate in this regard. He echoed the point made by one Member that Members' positions were well known with respect to the disclaimer. His delegation was concerned, however, about the fact that Members may have objections relating to the content of the document as on Tuesday reservations had been heard for the first time on the content,

beyond the issue of the disclaimer. He suggested that in the interest of time, and to avoid

reverting to a circular discussion on the disclaimer, it would be more effective to deal with substance first.

The representative of the United States sought clarification regarding which version of 2.282. document was under discussion: JOB/TBT/119 or JOB/TBT/119/Rev.1 (containing bracketed language)? Moreover, she invited the Chair to avoid drawing attention to the disclaimer by specifically referring to the adoption, or not, of the GRP document, rather than to discussion of the

disclaimer itself.

The Chairperson confirmed that the latest version was JOB/TBT/119/Rev.1; this was the 2.283. document being discussed along with the bracketed text therein. He remained of the view that if the issue of the disclaimer could be resolved, then the Committee could move forward.

The representative of Brazil said that his delegation was of the same understanding as the 2.284. Chairperson that the only document on the table was JOB/TBT/119/Rev.1; the only part in

brackets was the 'disclaimer'. He drew attention to the introductory part of the document

contained in paragraph 4, which read that 'this document may be reviewed as and when desired by Members', saying that this should answer Argentina's concern. He added that once the issue of the disclaimer was resolved, the document could be approved and that it was not possible to continue pursuing improvements and additions (with new GRPs). Finally, he alluded to another much more extreme course of events, whereby Members may have fundamental objections to the existing text because of it dating back to 2013, but clarified that no Member had done so explicitly.

The United States asked for confirmation that there were two sets of square brackets in 2.285. JOB/TBT/119/Rev.1.

The Secretariat said that the document referred to by the Chairman was 2.286. JOB/TBT/119/Rev.1, dated 4 December 2014, and that it contained one set of square brackets in paragraph 3 and another around the word 'may' on page 6. The Rev.1 version was the one closest to achieving consensus in the Committee; the JOB/TBT/119 version dated to October of the same

year.

The representative of the United States disagreed with the general view that 2.287. JOB/TBT/119/Rev.1 gathered most consensus as it was her delegation's understanding that document JOB/TBT/119 was the version that had been up for discussion at the November meeting. She stressed that JOB/TBT/119/Rev.1 did not have consensus as only a couple of Members wanted the additional proposed language.

The representative of Brazil requested additional confirmation that the only differences 2.288. between the two versions were the disclaimer and the square brackets around 'may'.

The Secretariat comparing the two versions, noted that in addition to the two sets of 2.289. square brackets already mentioned by the Chair, there were a number of other differences between the JOB/TBT/119 and its Rev.1, including: in footnote 4, in footnote 8 and substantive

changes on pages 7 and 10.

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The representative of South Africa recalled the discussion that had been held on 2.290. JOB/TBT/119/Rev.1 and confirmed that this was the latest version on the table and that it represented the closest the Committee had come to consensus, the only outstanding issues being the disclaimer and the word 'may' as had been mentioned by the Chair.

Argentina requested clarification on whether JOB/TBT/119/Rev.1 was the latest version of 2.291. the document on which subsequent past discussions had been held, including in informal mode.

The Chairman confirmed that since JOB/TBT/119/Rev.1 had been issued, all discussions 2.292. had been on that version. Moreover, any future discussions would also be based on that version. In summing up, he proposed to hold an informal meeting in advance of the next TBT Committee to address the issue of the disclaimer and to see if there had been any new developments from those Members who needed more time to consider the matter. Once that issue was resolved, the focus of discussions would move to finding a way forward and to see if there was room for agreement.

3 THE 23RD ANNUAL REVIEW OF THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT (ARTICLE 15.3)

The Secretariat drew the Committee's attention to the 23rd Annual Review of the 3.1. implementation and operation of the TBT Agreement (G/TBT/40) which contains information on developments in the Committee relating to the implementation and operation of the TBT Agreement from 1 January to 31 December 2017.

The Committee took note of the Review. 3.2.

4 TECHNICAL ASSISTANCE ACTIVITIES

The representative of Colombia thanked the WTO Secretariat for the national workshop on 4.1. the TBT and SPS Agreement that had taken place in Bogota in November 2017. 30 Participants

from standardizing bodies, agencies and the private sector had taken part. She hoped that there would be further technical assistance activities in Colombia as this provided an excellent opportunity to improve technical expertise among those working on TBT issues in various ministries.

The representative of the United States updated the Committee on TBT related technical 4.2. assistance activities that had been undertaken by the Standards Alliance.

The Secretariat updated the Committee on the TBT Advanced Course which took place from 4.3. 12-23 March 2018. There were 23 participants from all regions who worked in standard setting bodies, trade and foreign affairs ministries and parliament. The broad objectives of the course was to consolidate knowledge of the TBT Agreement, strengthen their capacity to engage in the work

of the TBT Committee, proficiency in the use of the on-line tools and strengthen their network of contents.

On ePing, the secretariat continued to provide training in the context of the range of technical 4.4. assistance activities and there would be a particular focus in 2018 on training enquiry points in the advanced features they can benefit from. She invited interested delegations to approach the TBT team for further information.

The Advanced Course participant from South Africa, on behalf of all participants informed the 4.5.

Committee that the course had equipped them with a deeper, comprehensive and practical understanding of the TBT Agreement and had also enhanced their knowledge of other agreements such as the SPS Agreement and the Trade Facilitation Agreement. Participants looked forward to returning home and contributing in the best possible way to advance international trade through the implementation of the TBT Agreement.

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5 UPDATING BY OBSERVERS

5.1 Updates

The representatives of the Codex, UNECE, UNIDO, WHO, BIPM and IEC96 provided updates. 5.1.

The representative of the United States expressed some concerns about the revision of 1994 5.2. Guide 59 on the Code of Good Practice for Standardization that was being undertaken by ISO. The full statement is contained in G/TBT/W/471.

5.2 Pending Requests

The Chairman recalled that the Committee had had an initial exchange in informal mode on 5.3. 23 February regarding procedures for dealing with pending requests for observer status

(G/TBT/GEN/2/Rev.14 and RD/TBT/1/Rev.6). The Secretariat had been tasked with following-up with those organizations whose applications were still pending. Earlier during the week, also in informal mode, the Secretariat had briefed the Committee on their contacts with the applicants.

Essentially, the Secretariat had heard that all observers that had pending requests except for the Gulf Organization for Industrial Consulting remained interested. The Secretariat also noted that the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) had been on the list for many years, that they had been active in the Committee's work, and were among those that had recently re-stated their willingness to be observers in the TBT Committee. Considering this, on Tuesday in the informal, the Chairman recalled that he had suggested that the Committee consider ILAC/IAF's observer status request at the present meeting.

However, the Chairman noted that some Members were not in a position to take a decision at the current meeting. Nevertheless, he wished to offer delegations an opportunity to make statements related to the list of applicants that we have before the Committee. The floor is open.

The representative of South Africa expressed his delegation's support to invite ILAC and IAF 5.4. to attend meetings of the Committee as observers. The full statement by is contained in G/TBT/W/525.

The representative of Trinidad and Tobago supported the application for observer status from 5.5.

ILAC IAF. In Trinidad and Tobago, there had been efforts to formalize the national quality policy infrastructure and framework of which the international accreditation programme was a critical part. Indeed, the use of accredited tests, certification, inspection and calibration services was a basic principle which facilitated trade. Observer status for the ILAC IAF would assist in reinforcing the principles and benefits of using conformity assessment procedures in trade. In addition, having a first-hand experience of concerns raised in the TBT Committee could better contribute to the

possibility of customizing conformity assessment solutions offered when and if needed.

The representative of the European Union said that, based on previous discussions and 5.6. especially on the basis of the wording of Item 5 of the Annotated draft Agenda, it had been the EU

understanding that substantive discussions on observership would take place at the June meeting. Therefore, the EU was not in a position to agree on or have substantive discussion on requests for observer status at the current meeting. However, with a view to future discussions, the EU stressed the importance of considering requests under the Rule of Procedure Rule 1197 which

provided that observer organizations needed to be international intergovernmental organizations.

The representatives of Brazil, Canada, Costa Rica, Singapore and the United States supported 5.7. the application of ILAC and IAF.

The representative of Turkey supported granting observer status to the Standards and 5.8. Metrology Institute for Islamic Countries’ (SMIIC). The full statement by Turkey is contained in G/TBT/W/526.

96 G/TBT/GEN/244, G/TBT/GEN/245, G/TBT/GEN/246, G/TBT/GEN/243 97 G/TBT/1/Rev.13, p.76 (as well as Annex B on p.81).

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The representative of Saudi Arabia believed that the participation of SMIIC to the TBT 5.9. Committee as observers could benefit the SMIIC by allowing it to be up to date with the latest developments and requirements on international trade. Saudi Arabia thus supported the request for observer status by SMIIC and encouraged the Committee to grant it.

The representative of Egypt expressed support for the requests from SMIIC and COMESA. 5.10.

The Chairman thanked Members for their engagement and noted that as list of 5.11.

organizations requesting observer was growing the Committee needed to address them. He suggested that: i) Members come prepared for the June regular meeting to consider the applications for ad hoc observer status from the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC); and, (ii) that the Committee in June choose which further request(s) to consider in November.

The Committee agreed on this approach. 5.12.

6 DATE OF NEXT MEETING

The next regular meeting of the Committee will be held on 20-21 June 2018. This will be 6.1. preceded by an informal meeting on the Eighth Triennial Review on 2018.

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