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G/TBT/M/72

25 September 2017(17-5076) Page: 1/45

Committee on Technical Barriers to Trade

MINUTES OF THE MEETING OF 14-15 JUNE 2017

CHAIRMAN: MR JOSE MANUEL CAMPOS (CHILE)

Note by the Secretariat1

1   ADOPTION OF THE AGENDA.....................................................................................12   ELECTION OF THE CHAIRPERSON.............................................................................13   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT..................................13.1   Statements from Members under Article 15.2............................................................................13.2   Specific Trade Concerns (STCs)..................................................................................................23.2.1   Reported resolutions................................................................................................................23.2.2   Withdrawn concerns................................................................................................................23.2.3   New concerns...........................................................................................................................23.2.4   Previously raised concerns.....................................................................................................133.3   Exchange of Experiences..........................................................................................................463.3.1   Thematic Session on Risk Assessment...................................................................................463.4   Eighth Triennial Review.............................................................................................................464   TECHNICAL ASSISTANCE ACTIVITIES.......................................................................465   UPDATING BY OBSERVERS.....................................................................................476   DATE OF NEXT MEETING........................................................................................47

1  ADOPTION OF THE AGENDA

1.1.  The Committee adopted the agenda contained in WTO/AIR/TBT/8.

2  ELECTION OF THE CHAIRPERSON

2.1.  The Committee elected Mr. José Manuel Campos (Chile) as the chairman for 2017.

3  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT

3.1  Statements from Members under Article 15.2

3.1.  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 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/39/Rev.1), issued on 18 May 2017. He informed the Committee that since the last meeting in March 2017, Gabon and Nepal had submitted statements. He further informed the Committee that since 1995, 138 Members had

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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submitted at least one statement of implementation. Information on the list of statements is available on the TBT IMS.

3.2  Specific Trade Concerns (STCs)

3.2.1  Reported resolutions

3.1.  There were no reported resolutions of STCs.

3.2.2  Withdrawn concerns

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

a. European Union — Regulation on the Registration, Evaluation and Authorization of Chemicals (REACH)

b. Colombia — Testing Requirements to be met by Toys and their Components and Accessories

c. Dominican Republic — Requirements for importing steel rebar - RTD 458 and other requirements

3.2.3  New concerns

3.2.3.1  China — Cyberspace Administration of China – Draft implementing measures for the Cybersecurity Review of Network Products and Services

3.1.  The representative of the European Union thanked China for the opportunity to provide written comments on the draft implementing measures for the Cybersecurity Review of Network Products and released for public consultation on 4 February 2017. He asked China to confirm that the final version released by the Cyberspace Administration of China (CAC) on 2 May 2017 would be notified to the TBT Committee. The EU appreciated that the final version seemed to have partly addressed some of the concerns raised (e.g. slightly narrowed scope, removal of the priority procurement requirement, introduction of appeal mechanism, clearer review focus and triggering mechanism) but that many remained, notably, the general nature of the measures and the very broad discretionary powers left to the authorities in charge of the security review, causing uncertainty for foreign ICT operators. The EU urged China to ensure the clarity, transparency and objectiveness of the security review. He further recalled the importance of clarifying the designation and work mechanisms of the Cybersecurity Review Committee, the Cybersecurity Review Expert Committee and third-party assessment bodies. Clear definitions and clearly specified detailed standards and other technical requirements should apply. Moreover, confirmation was sought that foreign vendors' intellectual property and trade secrets (in particular source code) would not need to be disclosed to third parties, and that it would provide for credible sanction and redress mechanisms for addressing information leaks to third parties and competitors.

3.2.  The representative of the United States, in echoing the concerns raised by other Members, remained troubled by what seemed to be a widespread effort by China to impose "secure and controllable" requirements on ICT products, especially as the term remained undefined. Her delegation was also concerned that the final version of the measure did not seem to take into account many stakeholder concerns. As the measure appeared to lay out a process for conformity assessment that would extend the "secure and controllable" requirement to services and supply chains, she asked how this was consistent with China's WTO TBT commitments. Clarity was requested on what specific standards constituted the "related standards" that Article 8 of the measure mandated entities undertaking the security review to reference. If these were to be TC 260 standards, the US underlined that they proposed an unprecedented approach to security assessment based on subjective criteria. China was therefore encouraged to engage in consultations with all interested parties and revise these standards to be in line with both international norms and the Code of Good Practice. Her delegation requested further details on when the list of products and services to be subject to security review, as flagged by CAC, would be released. She concluded by stressing her delegation's concern about China's approach to cybersecurity and its suite of measures that appeared to be inconsistent with its national treatment

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obligations and to discriminate against foreign technologies and firms in the name of information security.

3.3.  The representative of Japan expressed his delegation's concern and strong interest with regard to the measures, in particular with respect to, inter alia, the lack of clarity of articles regulating terms definitions, the concrete requirement for review and evaluation, and the scope of the regulation. Japan was concerned that the measures may hamper market access of foreign companies to China or cause the leakage of confidential technology, depending on concrete details of rules or implementation thereof. China was therefore requested to implement the measure in a non-discriminatory manner and not to make it more trade-restrictive than necessary, in line with the TBT Agreement. In addition, China was asked to clarify the terms' definitions, the concrete content of requirements and the scope of the regulation, to ensure transparency, and consistency with international standards and practices. With respect to the Security Review Measures, he asked China to clarify the designation criteria for the third party organizations undertaking cybersecurity reviews and "related standards" (Article 7 and 11); and the concrete meanings of the terms "critical industry management agencies" (Article 9) and "departments responsible for critical information infrastructure protection work" (Article 10). In addition, could China clarify if implementation systems and requirements for cybersecurity review in Article 9 and 10, and those conducted by government in Article 2, were the same? Regarding cooperation in Article 12, could China clarify the scope and implementation scheme of cooperation in order not to require the disclosure of technical information more than necessary? Japan therefore requested that the regulation be implemented transparently, and in full consideration of the views held by Japan and other countries.

3.4.  The representative of Australia expressed an interest in the measure and looked forward to an update on its implementation, as well as responses to the questions and concerns raised by other Members.

3.5.  The representative of Canada recognized the importance of safeguarding against network intrusions, terrorist acts, and other malicious cyber-attacks, as well as protecting users' personal information and sensitive data. His delegation believed that both China and Canada shared an interest in ensuring that network products and services be considered equally under China's cybersecurity regime, regardless of their country of origin, to ensure that critical industries were able to procure world leading technologies for the promotion of secure and efficient networks. Canada nevertheless agreed with the concerns already raised by the US and other Members. Since the Cybersecurity Law was first published for comments in July 2015, Canada had registered concerns about the potentially trade-distorting effects of the measures China was proceeding to implement.

3.6.  In the case of the draft Network Product and Services Security Review Measures, released by the State Internet Information Office on 4 February 2017, Canada had provided written comments on 4 March 2017, through the Canadian Embassy in Beijing. Canada appreciated the opportunity to comment on the Review Measures during the drafting stage and welcomed the chance to share best practices and lessons learned with China on similar information technology and security-related regulations and laws. He recalled Canada's recommendations in this regard: (i) where obligations apply to enterprises procuring network products and services, the implicated sectors should be clearly identified; (ii) the review criteria necessary for a product or service to be designated as "secure and controllable" should be clearly and comprehensively listed; (iii) greater clarity should be provided on how review procedures are to be conducted, and by which agencies and third party organizations; (iv) assurances should be provided that foreign network products and services will be afforded equal consideration and treatment under cybersecurity review proceedings; (v) the protection and confidentiality of an applicant's commercially sensitive information should be guaranteed under review proceedings; and (vi) creation of a review or appeal procedure for an interested party who believes the outcome of a security review may be flawed. Canada looked forward to receiving a response from the State Internet and Information Office.

3.7.  The representative of China underlined that the aim of the cybersecurity review was to guarantee as "secure and controllable" products and services which might endanger national security and public interests. The measures did not differentiate between Members, nor discriminate against foreign products and technologies. She said that rather than restricting the market access of foreign technologies, the review would help to increase consumer confidence and expand the market.

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3.2.3.2  China — Draft revised Encryption Law of the People's Republic of China by the Office of State Commercial Cryptography Administration (OSCCA)

3.1.  The representative of the European Union welcomed the public consultation by China on the draft Cryptography Law published by the Office of State Commercial Cryptography Administration (OSCCA) on which it had provided written comments. In those comments, concern had been raised that the draft law was very broad in scope covering areas ranging from research and commercial use to import, export and certification. He noted in this regard that most ICT products were not dedicated mainly to encryption, but only used some elements thereof. The draft law seemed to depart from international practice, as well as previous commitments by China, including the March 2000 Clarification by OSCCA, according to which ICT products would not be subject to licensing requirements and similar regulatory constraints unless the core function of the products was encryption. The EU deemed that the draft law potentially captured a much wider range of products subjecting them to restrictions. In this context, could China clarify the intended scope of the draft, especially by precisely defining key concepts such as "common", "core" and "commercial" cryptography.

3.2.  His delegation noted, moreover, that the draft law foresaw a pre-market approval obligation for commercial cryptographic products, a requirement deemed cumbersome and departing from international practice. The EU therefore called on China to ensure that regulatory requirements related to market access were non-discriminatory, technology neutral and did not lead to forced transfer of intellectual property (e.g. by requiring mandatory disclosure of encryption keys). Finally, the EU recalled the importance of developing and implementing international standards in the area of cryptography to ensure global interoperability. This key role of international standards should be recognized in the draft law. China was requested to take these comments into account and modify the draft law accordingly.

3.3.  The representative of Japan recalled that her delegation had submitted views on the Chinese draft encryption law during the public comment period in April 2017. Amongst other things, Japan was concerned about certain unclear articles such as those regulating the definition of terms, the concrete requirement for review, and the scope of the regulation. This lack of clarity also extended to the relevance of the law to existing security regulations such as "Regulation on the Administration of Commercial Cipher Codes" (promulgated on 7 October 1999) and "the Cybersecurity Law" (enacted on 7 November 2016). Japan's concern was that market access to China of foreign companies dealing in cryptography-utilizing products might be hampered or that confidential technology might leak out, depending on concrete details of the specific regulations or how to implement the applicable provisions of this law. She therefore requested that China clarify the definition of terms, the concrete contents of requirements and scope of the regulation, in order to ensure transparency. China was also encouraged to ensure that the relevant regulations and procedures be consistent with international standards and practices.

3.4.  The representative of the United States expressed grave concern regarding China's Office of State Commercial Cryptography (OSCCA) draft Cryptography Law of the People's Republic of China on which it had submitted comments to China in May 2017. The US was concerned that this law would codify potentially far-reaching, highly trade-restrictive cryptography-related constraints on foreign ICT products. Did China intend to notify this measure to the TBT Committee and allow for stakeholder comments, in accordance with its transparency obligations? She recalled that these concerns were not new. Indeed, provisions in the Draft Law seemed to contravene a number of bilateral and multilateral commitments that China had made in the past 17 years and were in direct conflict with globally accepted practices to assess encryption in commercial ICT applications. The US had expressed concerns about a number of China's cybersecurity-related measures in recent years, many of which raised serious issues relating to encryption; however, the codification of anti-foreign commercial encryption requirements into a law was of even greater concern than encryption requirements embedded in other measures.

3.5.  As China's approach with the Draft Law appeared to be much more trade restrictive than necessary, her delegation urged China to carefully consider input from all stakeholders, including the US Government and industry stakeholders, and to make substantial changes and clarifications to the Draft Law prior to implementation. For example, the law established a licensing scheme for all imports and exports of commercial cryptography. Could China explain how it planned to implement this scheme in line with its national treatment commitments? What steps was China taking to ensure the scheme would not be operated as an unnecessary obstacle to trade? The law also called for the continued development of a cryptography accreditation, testing and certification system. Given China's TBT obligations in Article 5, what steps was China taking to ensure this

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system would operate in accordance thereof? Specifically, how would China ensure that the conditions for foreign products were no less favourable than those accorded to domestic products? Particular concern had been raised by US industry that the system would require applicants to divulge source code and other sensitive design information; her delegation urged China to take these concerns into account when developing the system. Further noting that the law called for the development of national standards related to cryptography, the US encouraged China to develop these standards in cooperation with the international standards development work in this field and that these future standards not become an unnecessary obstacle to trade. Finally she requested an update on the status of the Draft Law, and asked how China intended to consider the public comments it received.

3.6.  The representative of Canada recalled that the draft Encryption Law of the People's Republic of China by the Office of State Commercial Cryptography Administration Cyberspace Administration had been released for public comment on 13 April 2017. Canada requested that China explain the reason why only 30 days, instead of the normal time limit for comments of 60 days, had been given and questioned whether China intended to notify the draft Encryption Law to the WTO. His delegation supported the concerns raised by the US and other Members on the draft law itself. In Canada's view, the law as drafted was more trade restrictive than necessary to achieve China's national security objectives and would have far-reaching implications for a range of companies that use or supply encrypted products and encryption-related services in China. Canada strongly encouraged China to consider the views raised by WTO Members and ensure that the draft law was consistent with WTO obligations.

3.7.  The representative of China stressed that the encryption law was an important piece of legislation in China's comprehensively deepening reform and advancing the the law-based governance of China. She added that during the drafting process, the principles of legislation based on law, science and democracy had been respected. In April 2017, the draft encryption law had been released for comments, and those received by the relevant authority would be carefully studied and taken into consideration during the draft revision process.

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

3.1.  The representative of Brazil thanked the EU for the very productive bilateral meeting held the previous day, during which the EU had provided answers to many questions. His delegation encouraged the EU to notify the proposed non-renewal of picoxystrobin to the SPS Committee due to the protection of human/animal health being its basic concept. Brazil was of the view that this non-renewal went against scientific consensus that the substance was safe to protect crops, particularly when it came to genotoxicity. Council Directive 91/414/EEC of the European Commission declared that picoxystrobin was not toxic, the report of the European Food Safety Authority (EFSA) claimed that it was not possible to conclude on the genotoxic potential of picoxystrobin based on the available data, and the Joint Committee of the FAO and WHO of specialists had also concluded that the substance was not genotoxic. He added that the substance was used in more than 65 countries and had been approved by many bodies, such as US Environmental Protection Agency, Canadian Management Regulatory Agency, Japanese Agency as well as in Brazil itself. His delegation considered that the maximum residue levels (MRLs) for picoxystrobin were already very low - for example, for soya the default was 0.01mg/kg – and therefore reiterated that the EU's non-renewal of picoxystrobin was in contradiction to scientific data and should be changed.

3.2.  The representative of Canada shared Brazil's concerns with the process being followed by the EU and the potential for the non-renewal of picoxystrobin, an active ingredient used as a fungicide on a wide variety of crops cultivated in Canada and exported to the EU. Her delegation encouraged the EU to base its scientific review process on international standards and to consider all data made available to it for the purpose of a review.

3.3.  The representative of Argentina expressed support for Brazil's intervention and emphasized its own concern at the EU's initiative for the non-renewal of approval of the active substance picoxystrobin and the consequent withdrawal from the market of phytosanitary products containing that substance. He recalled that picoxystrobin had been scientifically evaluated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), a group of experts which carried out exhaustive and rigorous risk assessments on pesticides, which were the essential basis for the standards subsequently adopted by the Codex Alimentarius Commission. The JMPR had concluded that it was not a genotoxic product, which meant that non-renewal of the approval of the active

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substance picoxystrobin was an unjustifiable deviation from international standards. In this light, the EU was asked to base its measures concerning picoxystrobin on the JMPR recommendations, and thus to comply with its WTO commitment to base its decisions on a risk assessment and not on unfounded assumptions relating to hazards.

3.4.  The representative of the European Union noted that, under Regulation (EC) No 1107/2009 on the placing of plant protection products on the market, only substances for which risk assessment was successful and for which the safe use was confirmed, could be approved. The risk assessment involved both the EFSA and all member States. Regulation (EC) No 1107/2009 made it clear that it was the responsibility of industry to demonstrate that substances placed on the market did not have any harmful effects on human or animal health or any unacceptable effects on the environment. According to the regulation, active substances could only be approved for use in plant protection products on fulfilment of certain criteria.

3.5.  She explained that picoxystrobin was part of the third stage of the EU renewal programme for active substances used in plant protection products and had been subject to a comprehensive assessment and peer review under EU rules. The large number of issues identified during the risk assessment and peer review of picoxystrobin had been presented in the EFSA Conclusion published in June 2016, which included a number of critical areas of concern and areas that could not be finalized related to both human health and the environment, as well as data gaps. The Commission proposal for not renewing the approval of picoxystrobin was based on the EFSA Conclusion, taking into consideration the approval criteria outlined in the legislation. Taking into account the data submitted in the renewal dossier, it had not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 were satisfied. Therefore, she said, it was not possible to renew the approval of the active substance. Her delegation highlighted, however, that a non-renewal decision did not prejudice the submission of a further application for the approval of picoxystrobin in accordance with Article 7 of Regulation (EC) No 1107/2009, provided that the necessary data could be submitted to address the concerns and issues identified. It was noted that the applicant for renewal did not agree with the outcome of the peer-review as detailed in the EFSA Conclusion. However, the outcome was the result of an extensive and rigorous scientific evaluation involving experts from EFSA and member States. According to EU legislation, EFSA conclusions should be taken into account in the decision-making for an active substance.

3.6.  In relation to the assessment of genotoxicity, the EU stated that the Commission proposal for non-renewal did not, in any way, state that picoxystrobin was a genotoxic substance, but rather that, on the basis of the information available in the dossier, it was not considered possible to conclude on the genotoxic potential of picoxystrobin. However, it was also important to highlight that the incomplete assessment of genotoxicity was one of several concerns identified, and that the other issues identified precluded themselves the renewal of approval. She explained that the EU had discussed the EFSA Conclusion with the applicant on several occasions and had also carefully considered all comments received during the decision-making process. However, given that EU legislation laid down strict rules for approval which had not been satisfied, a proposal for the non-renewal of the approval of picoxystrobin was the appropriate course of action.

3.7.  The EU considered that the notified draft was in line with the TBT Agreement (scientific output and a conclusion of EFSA) and that it did not lead to immediate disruptions in trade, as the measure itself did not amend the MRLs and provided for a grace period. Furthermore, the TBT notification made it clear that any action to reduce MRLs would be subject to a notification under the WTO/SPS procedure. Given the issues identified by EFSA, it was likely that a proposal to lower MRLs would be made. Import tolerance requests would remain possible only if safety for consumers could be demonstrated. She concluded by stating that since, in May 2017, a decision had not been reached on the EU proposal, discussions with member States were currently ongoing. The Commission remained of the opinion that the non-renewal of approval was the only appropriate action.

3.2.3.4  China — Limits and Measurement Methods for Emissions of Light-duty Vehicles (China 6) G/TBT/N/CHN/930/Rev.1

3.1.  The representative of Japan, whilst appreciating China's efforts to improve air quality, expressed concern that the measures notified in G/TBT/N/CHN/930/Rev.1 on 3 October 2016 (hereinafter, the "China 6") were extremely strict compared to other international standards and imposed difficult technical challenges to the automobile industry. Japan had submitted comments to China on 29 November 2016 on China 6. Firstly, China's conformity assessment criteria of in-use

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vehicle conformity testing as stipulated in China 6, which his delegation believed should have been discussed with the criteria of limit value, had suddenly changed and had become substantially stricter than its draft standards released in May 2016. Japan therefore requested China to revise the conformity assessment criteria. Secondly, with respect to the China 6 PN/RDE regulation which posed many unresolved technical issues, Japan requested that the plan for early enforcement of China 6 in designated cities be reviewed. Since industries required sufficient lead time to supply vehicles in conformity with the PN/RDE regulation, it was suggested that the regulation should not be implemented prematurely. Moreover, he expressed concern that there had been no response from China to Japan's comments when China 6 had been officially announced on 23 December 2016. Despite the unresolved technical issues, some designated cities had stated their intention to start enforcing the China 6 6b standards from July 2018. He reported the difficulty of supplying vehicles in conformity with such standards to the market by the date of enforcement since some parts of the testing method and preparation of testing laboratories had not yet been sufficiently developed. His delegation was concerned that the initiative, which Japan deemed hasty, was causing great confusion in the automobile industry. Under these circumstances, Japan requested China to carefully examine the current situation of preparation of the relevant agencies and institutes for China 6 and to postpone any early enforcement plans in designated cities.

3.2.  The representative of China stated that China 6 had been notified in accordance with relevant procedures. The China 6 standards, released in December 2016, stipulated that from 1 July 2020 all light-duty vehicles on sale or registered should meet such requirements and as a result should be in conformity with 6a requirements in type I test; furthermore, from 1 July 2023, all light-duty vehicles on sale or registered should meet the requirement, and as a result should be in conformity with 6b requirements. She clarified that local governments could set up their own timetable of China 6, in accordance with local situations.

3.2.3.5  China — Internet of Vehicles Cybersecurity Protection Guideline Rules

3.1.  The representative of the United States expressed concern about the draft Internet of Vehicles Cybersecurity Protection Guideline Rules developed by the Telematics Industry Application Alliance (TIAA). As noted many times at TBT Committee meetings in recent years, her delegation remained very concerned about China's policies that appeared to discriminate against foreign technologies and firms in the name of information security and the US believed these new rules would similarly unnecessarily restrict trade. In a letter dated 17 April to MIIT Vice Ministers Liu Lihua and Xin Guobin, the US had communicated some of its specific concerns and views of industry stakeholders, in the hope that they would be seriously addressed by TIAA. She pinpointed a number of troubling elements in the rules, similar to elements in China's other cybersecurity policies, including: poorly defined key terms, such as "critical" and "IoV Systems"; an unclear, but apparently broad, intended scope; data localization requirement (in this case, that the computer rooms for service platforms must be located in China); creation of a security risk assessment regime.

3.2.  She then outlined the following concerns which had been specifically noted by US industry and government. First, provisions requiring an undefined security assessment for security software used by connected vehicle companies, and giving priority to products that had passed this assessment, could be applied in a manner that disadvantaged US products and services. Second, requirements for server rooms for service platforms to be located in China would disadvantage non-Chinese companies. Third, the rules were unclear on implementation details. Industry was especially concerned that the requirements would be applied to existing deployed technology retroactively, or implemented with a short time to become compliant. Since Internet of Vehicles (IoV) technology was centred around autos, which may be in operation for many years after purchase, applying the requirements retroactively could make compliance unnecessarily onerous. Fourth, the rules essentially placed the burden of cybersecurity compliance on a single type of entity, the IoV "Operator". Industry had stressed that many different companies played a role in connected vehicle technology, and that a better approach would be to encourage all of them to collaborate on cybersecurity protection. Lastly, on the understanding that compliance with the rules was voluntary, there was concern that in practice compliance would be made mandatory. In fact, the rules even noted that they had been developed under the guidance and direction of Chinese government agencies including MIIT and OSCCA. Should the rules be made mandatory by incorporation into technical regulations or conformity assessment procedures, the US expected China to comply with its WTO commitments and notify the measure to the Committee for a comment period of 60 days. Furthermore, it was expected that at least a six-month delay between the close of the comment period and the date of implementation be provided for industry to adapt to the new requirements.

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3.3.  While her delegation recognized the interest of China and all countries in protecting essential security interests, strong concern remained with the overall direction of China's cybersecurity approach, especially as codified in its Cybersecurity Law. It was deemed that China's suite of cybersecurity measures had the potential to adversely affect US exports of high technology products and services, as well as those made or supplied by US investors in China. In general, these measures were considered potentially inconsistent with China's national treatment obligations and to discriminate against foreign technologies and firms in the name of information security. The US therefore reiterated the importance of ensuring that China's approach was consistent with its WTO obligations and bilateral commitments.

3.4.  The representative of China stated that Internet of Vehicles Cybersecurity Protection Guideline Rules was a voluntary measure, drafted by TIAA, and released for comment in February 2017. Her delegation believed that cybersecurity was very important for internet of vehicles in order to ensure data and information security thereof, to protect consumer privacy and interests, and to maintain the rules of fair competition. TIAA, an open, independent and third-party industry organization, had developed these guideline rules following technical trends and market requirements, and abiding by the principles of voluntary and self-disciplined.

3.2.3.6  China - Civil Aviation Network Information Security Management Rules

3.1.  The representative of the United States said that despite having raised concerns about China's suite of "secure and controllable" measures both bilaterally and in the Committee since early 2015, China was seen to be pressing forward with its efforts to impose "secure and controllable" requirements for ICT products in yet another sector – civil aviation. She asked whether China intended to notify the measure to the TBT Committee and allow for stakeholder comments, in accordance with its transparency obligations under the TBT Agreement and with its 2016 Joint Commission on Commerce and Trade commitment to notify all relevant "secure and controllable" technical regulations to the TBT Committee. Her delegation was concerned with the inclusion of the concept of "secure and controllable" in the measure, as it had been known and understood in the past to include references to domestic technology requirements. Companies sourcing ICT products were already interpreting this language conservatively, meaning that they believed they were required to purchase only domestic goods. This was similar to trends seen in banking and other industries that China had deemed to be critical information infrastructure. China was asked to explain how the measure was in line with its national treatment commitments under the TBT Agreement.

3.2.  Concern was also raised with the inclusion of the concept of "hierarchical protection systems" as it seemed to imply using the Multi-Level Protection Scheme (MLPS) as a basis for evaluation. Her delegation had objected to MLPS many times and had raised it both bilaterally and in the Committee since 2010, as it mandated domestic IP localization. Because civil aviation was inherently reliant on the IP of countless global suppliers, any move to impose IP localization requirements ran the risk of diminishing cybersecurity by preventing the use of cutting edge technologies to address the dynamic threat. Moreover, the US believed that it was inherently trade restrictive and called into question China's TBT commitments. She reiterated the request to delay the implementation of this measure until its scope and impact were better defined, especially given the possible unintended consequence of degrading aviation safety. She repeated her delegation's more general concerns with China's approach to cybersecurity, as expressed under the STC on Internet of Vehicles.1

3.3.  The representative of the European Union expressed support for the comments raised by the US and referred to his delegation's concerns to be raised in detail in the context of the STC on China's Cybersecurity Law.2

3.4.  The representative of Canada, echoing his delegation's comments related to the new STC on Cybersecurity Review of Network Products and Services3, raised concern about the measures emanating from the Cybersecurity Law first published for comments in July 2015. He supported the US' comments with respect to the civil aviation network security management rules and encouraged China to notify the measure to the TBT Committee.

1 See para. 3.2.3.5.1  3.3.  2 China – Cybersecurity Law (IMS ID 526).3 See paras. 3.2.3.1.1  3.5.  - 3.2.3.1.1  3.6.  

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3.5.  The representative of China stated that the Civil Aviation Network Information Security Management Rules regulated the relevant functions in the civil aviation sector. She asked Members to further elaborate their concerns to enable the relevant authorities to provide a detailed response.

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

3.1.  The representative of the United States expressed strong support for the objectives of the European Union and the European Chemicals Agency (ECHA) to protect the health and safety of its workers, consumers and the environment, in the use of chemicals and other substances. In regard to titanium dioxide, her delegation was concerned that recent actions by ECHA to review it for harmonized classification as a suspected carcinogen were taking place before the Community Rolling Action Plan (CoRAP) process could be initiated. She said that a suspected carcinogen classification of titanium dioxide could affect its use in thousands of products due to the required carcinogen labelling, disrupting global commerce. Moreover, she expressed surprise, given the longstanding and widespread use of titanium dioxide in so many products.

3.2.  ECHA's Risk Advisory Committee (RAC) review of the Harmonised Classification and Labelling (CLH) classification of titanium dioxide prior to the completion of the REACH Substance Evaluation appeared to deviate from the typical process set out in ECHA's own guidance on the preparation of a CLH dossier.4 In addition, the RAC review under the CLH process (CLP) up-ended stakeholder plans to prepare evidence and submissions for the CoRAP review. Her delegation believed that the CLH decision may therefore lack the benefit of data necessary for a sound decision. These concerns with both the regulatory procedures and the weight of scientific evidence presented in the TiO2 CLH dossier had been expressed bilaterally with the EU in March 2017 and followed up with written questions. Written comments from industry had also been transmitted directly to the EU and via the WTO TBT enquiry point but to date no response had been received.

3.3.  The US understood that the RAC was now in the process of completing its scientific opinion on the classification, and noted its industry's concerns that the CLH dossier submitted for the RAC review did not follow ECHA guidance in terms of the process and criteria used to identify and to screen scientific studies to be included in the dossier. It also excluded relevant studies on titanium dioxide completed by competent EU authorities, including a number of reviews on its use in cosmetics carried out by the European Scientific Committee on Consumer Safety (SCCS). Industry had also questioned ECHA guidance and basic good practices in scientific methodology in its decision on a carcinogen classification of titanium dioxide based upon animal studies, given the availability of a number of extensive and recent human studies. The choice of rats was also a concern, given that the species was prone to tumours and due to the existence of important physiological differences between rats and humans, raising questions about the utility of the findings when considering the human impact. Indeed, she said, studies of titanium dioxide in other mammals had found no evidence of carcinogenicity.

3.4.  Given these concerns, the US asked that the EU suspend any opinion on TiO2 to allow for the completion of the CoRAP and for the consideration of the full body of evidence related to TiO2. Her delegation urged the EU to consider its request as it held that an incorrect classification of titanium dioxide would be extremely disruptive for both the millions of consumers and companies who relied upon the performance and safety that it brought to many products, from sunscreens for cosmetics to reflective paint for safety markings on highways, for which there were no easily available substitutes. In view of the potential impacts on this $20 billion dollar industry, the US urged the EU to provide a review that was procedurally transparent and thorough.

3.5.  The representative of the European Union thanked the US for its comments on the scientific opinion to be taken on the hazard classification of titanium dioxide by the ECHA RAC in accordance with EU Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation). France had submitted a CLH dossier proposing to classify titanium dioxide as a carcinogenic substance Category 1B to be included in Annex VI of the CLP Regulation. This dossier had been subject to public consultation from 31 May to 15 July 2016. ECHA had received several comments, including from US individuals and organizations. Public authorities had been invited to send their comments as well. After the public consultation, the RAC had discussed the issue on several occasions: an introductory session had been held in March 2017; further discussion had taken place on 1 and 8 June 2017; and in the meeting of 8 June the RAC had

4 See Section 5.2.2. of https://echa.europa.eu/documents/10162/13626/clh_en.pdf/36b11f14-01a0-4474-be46-e48dd9b27849

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concluded on the classification of TiO2 as Carcinogenic Category 2. He specified that the scientific aspects of the classification process of titanium dioxide were dealt with by RAC with only marginal involvement from the Commission.

3.6.  He said that following the RAC's determination of titanium dioxide as a carcinogenic substance Category 2, in 2018 the Commission would prepare an Adaptation to Technical and Scientific Progress (ATP) amending the CLP Regulation to include titanium dioxide in the list of substances with harmonized classifications. He explained that ATPs were typically first presented to CARACAL (the expert group for REACH and CLP), after which they were put to the vote in the REACH Committee (the regulatory committee for implementing legislation prepared by the Commission). Timing of the vote in the REACH Committee meeting was typically in Q3 or Q4 of the year (i.e. 2018 in this case). After adoption of the ATP, a transitional period of typically 18 months applied, meaning that the harmonized classification of titanium dioxide would only apply as of around mid-2020 (adoption end of 2018 plus an 18-month transitional period). Duty holders were allowed to apply the harmonized classification voluntarily before that date.

3.7.  The EU reassured the TBT Committee that any proposal to classify titanium dioxide as a carcinogenic substance to be included in Annex VI of the CLP Regulation would be notified to the WTO, as usual, at the latest 60 days before the vote in the REACH Committee. All comments sent by WTO Members would be duly taken into account by the Commission in the decision-making process for the formal adoption of a RAC opinion. Finally, he clarified that the CLP and the substance evaluation (REACH) were two different processes under two different legislations. Indeed, both processes could be instigated independently from each other. Specifically for CLH, all adequate and reliable information available at the time of assessing would be taken into account but whenever new information became available, a new CLH could be started, by an EU member State or by the industry.

3.2.3.8  Oman, Kingdom of Bahrain, State of Kuwait, Qatar, Kingdom of Saudi Arabia, United Arab Emirates, Yemen - Guide for control of imported foods – Certification requirements for animal products G/TBT/N/OMN/198, G/SPS/N/BHR/164, G/SPS/N/QAT/22/Add.3, G/SPS/N/OMN/44/Rev.1/Add.1, G/SPS/N/SAU/14/Add.2

3.1.  The representative of the United States understood that the GCC member states had been working on the Guide for Control on Imported Foods (Guide) in order to harmonize food import procedures and requirements across the GCC and that after recently made changes, the revised Guide was to be published by April and implemented "on a trial basis", from 1 April to 1 October 2017. Her delegation had yet to see the revised publication. The US considered that given the potentially extensive nature of the changes in the GCC Guide and impact on trade, the lack of clarity in some of the requirements, and the time needed to make any changes to meet the new requirements, the grace or trial period was insufficient and requested a reasonable transition period that would allow stakeholders adequate time to comply in order to avoid a trade disruption. She said that whilst the US appreciated that the Guide had been previously notified as an SPS measure, TBT elements to the measure had been noted; all GCC member states were encouraged to notify it to the TBT Committee as well. She asked whether GCC technical experts would be willing to meet bilaterally to discuss the "alternative approaches" provision that was not detailed in the Guide. Given their long history of trade, the US looked forward to continuing to provide safe, quality, US food and agricultural products to its partners in the Gulf region.

3.2.  The representative of the European Union expressed concern that the revised Guide had not been notified in accordance with the TBT Agreement, despite its significance for trade and its relevance thereto, but only in accordance with the SPS Agreement. He stressed the need for full transparency, and underscored the importance of open and direct contact with trading partners on measures of concern in accordance with WTO agreements.

3.3.  The representative of the GCC (Kingdom of Bahrain) reported that implementation of the GCC Guide had been suspended until further notice. He indicated that the GCC member states were still in the process of submitting the addenda to relevant notifications to indicate the delay and would in turn notify its implementation in the future. The GCC members were available for bilateral talks if needed.

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3.2.3.9  Nepal — National Alcohol Regulation and Control Policy – Graphic Warnings and Statements for Alcoholic Beverages

3.1.  The representative of the United States referred to the endorsement by Nepal's Cabinet of a new National Alcohol and Regulation and Control Policy, which intended to place restrictions on labelling and advertising for alcoholic beverages, such as a requirement for a graphic warning label against the harmful effects of excessive alcohol consumption. The cabinet was also directing the development of a new alcohol standard. Whilst strongly supporting Nepal's desire to reduce the impact of excessive alcohol consumption on its citizens and recognizing the importance to public health which these measures intended to address, her delegation requested further information about Nepal's specific health concerns related to alcohol. In particular, what was the rate of consumption and what types of alcohol were mostly consumed? Could further information be provided on the ten WHO strategies referred to in Nepal's policy document as obligating Nepal to implement these policies?

3.2.  Her delegation understood that the requirement for a health warning label was not currently being enforced, but that implementing measures were under discussion; she requested confirmation of the status of the policy as well as plans and a timeline for implementation. She then stated that if the measure would apply to imported products, the US believed that it would have a trade impact as it would require producers to relabel their products. She therefore reiterated the request made via Nepal's WTO TBT Enquiry Point on 24 March 2017 for Nepal to notify any proposed implementing measures under the terms of the TBT Agreement to allow Members a reasonable time to provide written comments, discuss these comments on request and for Nepal to take those comments into account before finalizing any measures. Finally, information was requested as to how Nepal had developed the specific policy to cover 75% of a bottle with a picture. Nepal was encouraged to consider the approach taken by major alcohol-consuming and producing countries to managing the public health impacts of excessive alcohol consumption and the development of alcohol standards. Her delegation welcomed the opportunity to share its own experience in achieving these goals in the US.

3.3.  The representative of the European Union expressed interest in the policy under preparation and invited Nepal to notify it at an early appropriate stage, as provided for in Article 2.9.2 of the TBT Agreement.

3.4.  The representative of Canada echoed the concerns raised by the US and the EU and said that her delegation would continue to monitor developments regarding the policy. While recognizing Nepal's efforts to minimize the detrimental health impacts associated with excessive alcohol consumption, Canada remained concerned that the proposed regulation could have a negative effect on trade. In accordance with Article 2.9.2 of the TBT Agreement, Canada encouraged Nepal to notify the proposed measure and welcomed the opportunity to provide comments.

3.5.  The representative of Nepal committed to consult with its capital and provide further information on the matter in the coming days.

3.2.3.10  United States - Standards of Identity for Cheese

3.1.  The representative of Canada stated that in advance of the Committee on Agriculture meeting on 7 June 2017, his delegation had submitted several questions to the US concerning its standards of identity for cheese. In response, the US had indicated that its position was that the questions were outside the scope of that committee and suggested they be raised at the WTO TBT Committee. He expressed surprise that despite the fact that Canada had consistently answered questions from Members in the past on its cheese compositional standards in the Committee on Agriculture, as well as many other questions from the US on Canada's agriculture-related domestic regulations, his delegation was presently asking for further information at the TBT Committee. Specifically, Canada was concerned about the potential discriminatory effect of the standards of identity for cheese on imported ultrafiltered milk for standardized cheese making. In Canada's view, the elements of these US cheese identity standards seemed to fall disproportionally on imported ultrafiltered milk to the benefit of users or producers of domestic ultrafiltered milk. Canada thanked the US for its verbal responses given during bilateral meetings earlier in the week and looked forward to receiving written responses. In particular Canada welcomed any information on the confirmation of Canada's understanding of the cheese standards of identity as well as US enforcement practices of all elements of the standards. This included: (i) the enforcement of the US cheese standards of identity not allowing the use of ultrafiltered milk in the process of standardized cheese making unless the source of the ultrafiltered milk was from the cheese plant itself; and (ii)

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different labelling requirements for standardized cheese using ultra filtered milk produced off site than for standardized cheese made using ultra filtered milk produced at the same cheese plant.

3.2.  The representative of the United States was of the understanding from the bilateral meeting that Canada had no active export problems or concerns. She therefore sought insight into why Canada was currently interested in the standard of identity in the production of standardized cheese, as the US standards for identity of cheese had been in place for a number of years. Moreover, her delegation was not aware of Canadian firms experiencing difficulties in exporting to the US. She did, however, draw attention to a new dairy pricing ingredient programme implemented by the Government of Canada and Canadian provincial governments which had resulted in a substantial reduction to the value of US ultrafiltered milk exports. She underlined that the US FDA standards of identity were determined in an open and transparent process which relied upon engagement of all stakeholders and were finalized in the US code of federal regulations (to be found at 21CFR 133 for cheese products).

3.2.3.11  United States - Wisconsin butter laws

3.1.  The representative of Canada stated that his delegation had asked questions to the US at the Committee on Agriculture meeting of 7 June 2017 regarding Wisconsin butter laws. The US had responded in the same way as for questions on its cheese standards of identity; that the questions were outside the scope of that committee and suggested they be raised at the TBT Committee. Canada was concerned specifically with the Wisconsin state law that prohibited the sale of butter without either a Wisconsin or federal grade mark. Canada looked forward to the written responses from the US.

3.2.  The representative of the United States said that it was her delegation's understanding that Canada had no active export problems or concerns. The US government could not comment on the objective of the 1953 Wisconsin State law. Her delegation believed, however, from the text of the Wisconsin law, that it was focussed on providing product quality information. The US would take any concerns from Canada back for consideration.

3.2.4  Previously raised concerns

3.2.4.1  India — Pneumatic tyres and tubes for automotive vehicles G/TBT/N/IND/20 G/TBT/N/IND/40 (IMS ID 1335)

3.1.  The representative of the European Union repeated her delegation's concerns with the Indian measure at issue which introduced a certification procedure with a mandatory marking for tyres. The EU thanked India for detailed information regarding the ISI marking fee and the US$10,000 bank guarantee. India was requested to align its procedures to international practices and remove the obligation to pay a marking fee per marked tyre and to eliminate the discriminatory bank guarantee requirement. She understood that India had reduced in the Scheme of Testing Inspections (STI) 15633/6 of March 2016 the number of conformity of production (COP) testing needed to multiples of 30,000 tyres. The EU said this was a relief for the industry and recognized the steps taken in finding a compromise with Indian local industry. The EU considered that these testing requirements were burdensome and costly and asked what specific safety-related objectives India was pursuing by requiring such test frequency. She recalled that international practice was to carry out COP tests every two years and regardless of the number of tyres.

3.2.  The representative of the Republic of Korea repeated the concerns raised in the previous meeting, 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.

3.3.  The representative of Japan expressed support for the position of the EU regarding this issue. His delegation remained concerned about the extensive marking fee and long term for certification. Currently, Japan continued to check the facts regarding the basis of calculation of the marking fee to reach a satisfactory conclusion through closed bilateral meetings.

3.4.  The representative of India stated that the issues raised were not new and had been explained several times in previous meetings. He referred Members to responses provided in previous meetings. He recalled that Article 5.6 of the TBT Agreement required the notification of conformity assessment procedures that were not in accordance with international guides and

5 For previous statements follow the thread under IMS ID 133 (under dates raised and references).

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noted that the BIS Product Certification Scheme was based on the international standard ISO/IEC 17067 (Type 4). He highlighted that STI was a condition of the Bureau of Indian Standards (BIS) licence and was applied without discrimination. He noted that the performance bank guarantee was intended to protect the BIS during the tenure of the licence 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. India referred Members to its position in previous meetings concerning the concern on excessively high marking fees. In addition, he said that BIS was a non-profit organization, 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.

3.2.4.2  China — Provisions for the Administration of Cosmetics Application Acceptance G/TBT/N/CHN/821 (IMS ID 2966)

3.1.  The representative of the European Union welcomed China's plans to set up a differentiated approach between priority cosmetics ingredients (of higher risk and requiring a premarket registration) and ordinary ingredients, which would only need to be notified to the competent Chinese authorities. She asked for an update on the state of play of the measure.

3.2.  The representative of Japan noted that China had spoken of a revision to the measure at issue at previous meetings. He reiterated calls for clarification in this regard, and asked that an opportunity for public comment – in accordance with WTO/TBT disciplines – be provided. Japan remained concerned about the time it took for examination, the safety evaluation requirement and requirements on information disclosure.

3.3.  As there were no further updates to give, the representative of China referred to responses given at the previous meeting.

3.2.4.3  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 2747)

3.1.  The representative of the European Union appreciated the clarifications and explanations given by India at previous TBT Committee meetings, and asked India to urgently clarify the effective date of entry into force of the testing requirements, which the EU understood was postponed until 1 April 2018. The EU repeated the concerns expressed in the previous meeting.

3.2.  The representative of the United States repeated the concerns expressed in the previous meeting.

3.3.  The representative of Japan expressed support for the statements by the EU and the US. She repeated the concerns expressed in previous meetings. Japan requested that India implement the regulations in a more transparent manner. Japan noted that India released draft implementing regulations for in-country security certification on 24 May 2017, and the deadline of submitting comments was 1 June 2017, later extended to 24 June. Japan was concerned that the comment period was too short for industries to examine and implement the draft regulations. Japan requested India to carefully consider the specific content of testing modalities and provide sufficient time for their implementation, so as not to impede market access for foreign industries.

3.4.  The representative of Canada repeated the concerns expressed in previous meetings.

3.5.  The representative of India repeated the explanations provided in previous meetings, contained in paragraphs 2.72-2.73 of G/TBT/M/70. India noted that the deadline for the in-country security certification had been extended to 1 April 2018, and the notification to this effect was available on the website of the Department of Telecommunications. He clarified that the status quo regarding security testing and certification requirements would continue until the extended date.

6 For previous statements follow the thread under IMS ID 296 (under dates raised and references).7 For previous statements follow the thread under IMS ID 274 (under dates raised and references).

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Finally, he said that 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.

3.2.4.4  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 4898)

3.1.  The Chairman informed the Committee that Members had requested, in the interest of time, that these three specific trade concerns that had been raised separately in the past be combined, as many of the concerns overlapped.

3.2.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings and requested China to notify draft measures in any subsequent sectoral implementation to the TBT Committee in order to give adequate opportunity for Members and their stakeholders to comment on any subsequent developments. Specifically regarding information security in the banking sector, the EU would appreciate an update by China on the status and expected timeline of the possible revision of the Guideline for Promoting the Application of Secure and Controllable Information Technology in Banking Sector (2014-2015).

3.3.  As for the rules applicable to the insurance sector, the representative of the EU reiterated its concerns regarding the draft insurance sector informatization rules, which had the effect of mandating insurance institutions in China to progressively phase out non-domestic cryptographic products. This would be tantamount to a ban on procuring foreign cryptography products compared with domestic products. It would prevent insurance institutions from using the most developed and innovative encryption products and solutions, which would have the unintended consequence of weakening rather than strengthening information and network security. The EU recalled that the concept of "secure and controllable", which was also used in the National Security Law and the Cybersecurity Law, lacked precision and created uncertainty for economic operators.

3.4.  In addition, the representative of the EU raised its concerns regarding the requirement that insurance institutions obtained the ownership of the source code of the equipment and the compulsory use of national standards and encryption requirements based on national algorithms. The EU would therefore appreciate an update with respect to the revision of the measure. He asked China to confirm if the revised draft would be notified to the WTO for comments. The EU recalled the importance of allowing for adequate participation of interested parties in the domestic processes.

3.5.  The representative of Canada repeated concerns raised in previous TBT Committee meetings and echoed the views of other WTO Members regarding CIRC Information and Communication Technology Regulation.

3.6.  The representative of Japan still had concerns about the three regulations.9 With respect to Chinese Banking IT Equipment Security Regulation, he recalled China's explanation of the expired Guideline for Promoting the Application of Secure and Controllable Information Technology in Banking Sector (2014-2015), where there was no timetable for further development of any guidelines. He asked if China had a plan to revise the Guideline or to draft new ones. If any guideline was to be issued, Japan requested China to inform the Members concerned of the future schedule. If no guideline was revised or newly drafted, Japan requested China to ensure that the Guiding Opinions of the China Banking Regulatory Commission on Strengthening the Banking Network Security and Information Technology Construction, issued on 3 September 2014, no longer had any effect on banking IT equipment. In addition, Japan asked China's view on how to deal with the security regulations on banking IT equipment under the Cybersecurity Law.

3.7.  Regarding both the Banking IT Equipment Security Regulation and CIRC Information and Communication Technology Regulation, he stated that if China required source codes submission

8 For previous statements follow the thread under IMS ID 294, IMS ID 457 and IMS ID 489 (under dates raised and references).

9 Chinese banking IT equipment security regulation, CIRC Information and Communication Technology Regulation, and the MLPS.

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for risk assessment without clarifying the range of data scope, it would be more trade restrictive than necessary in light of the regulation objective. Japan therefore requested China to review these regulations to ensure transparency and compliance with international standards. With regard to Article 56 of CIRC Information and Communication Technology Regulation, which prescribed the application of MLPS, Japan was concerned that requiring Chinese intellectual property in core technologies or requiring domestic certification in China might cause discrimination of foreign companies in some levels. Japan recalled China's explanation that MLPS would be revised and adjusted appropriately in line with the principles of the Cybersecurity Law and requested that the revised draft regulation be no more trade restrictive than necessary, comply with international standards, and be based on the opinions of Japan and other Members.

3.8.  The representative of the United States remained very concerned about China's suite of measures 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. China's draft measures for "secure and controllable" technology in the banking sector continued to affect sales of foreign technology to banks in China. Without China's announcement that such rules or other measures restricting or limiting the use of foreign technology products in the banking sector would not be imposed at a later date, the banking sector remained reluctant to purchase foreign technology products, which raised concerns of national treatment. The US urged China to uphold its transparency commitments by notifying relevant technical regulations to the WTO TBT Committee, publicly soliciting comments, and taking into account stakeholders' comments from the US Government, industries, and foreign governments before implementing any similar cybersecurity measures in the banking or other commercial sectors. She reiterated the concerns raised in previous TBT Committee meeting on China's commercial encryption products and its on-going revision and the MLPS. Her delegation hoped that China would take into account all stakeholders' comments made on the draft standards related to MLPS, but more broadly to adopt international standards instead of creating country-specific ones.

3.9.  The representative of Australia repeated concerns raised in previous TBT Committee meetings and supported the concerns raised by others regarding the proposed CIRC Information and Communication Technology Regulation and the Banking IT Equipment Security Regulation. He understood China's desire to protect ICT infrastructure, but questioned whether the proposed measures were more trade restrictive than necessary. His delegation requested further information from China on the status of the regulations and whether they would be permanently withdrawn.

3.10.  The representative of China stated that regarding the OSCCA 1999 Regulation on Commercial Encryption Products, its on-going revision and MLPS, MLPS played an important role in guaranteeing cybersecurity. Both the Regulation on Commercial Encryption Products and the Information Security MLPS would be revised to be in line with Cybersecurity Law. China would take its trading partners' concerns into consideration. With regard to the relationship between Cyber Security MLPS and Information Security MLPS, the Cyber Security Law was fundamental to China's cyber and information security. It was based on the new features of cyber security, and meant a new phase for Information Security MLPS. Information Security MLPS would be revised to be in line with the principles of the Cyber Security Law.

3.11.  The representative explained that the Guideline for Promoting the Application of Secure and Controllable Information Technology in Banking Sector (2014-2015) had expired. Her delegation would always persist in its opening-up policy and abide by its WTO commitments. China was always open and transparent in building up commercial banking information system, which also conformed to long-term interests of further development of China's banking sectors.

3.12.  Regarding measures on insurance, China paid great attention to cyber and information security works. The aim of drafting this CIRC Regulation was to ensure information security in the insurance sector. This process had been carried out in an open and transparent manner. China had notified this Regulation to the WTO and was now carefully studying all the comments. She thanked Members for the bilateral engagement and reemphasized that China was willing to consult with all interested Members and stakeholders on this matter.

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3.2.4.5  Russian Federation — Draft Technical Regulation on Alcohol Drinks Safety (published on 24 October 2011), G/TBT/N/RUS/2 (IMS ID 33210)

3.1.  The representative of the European Union repeated the concerns raised in previous meetings.

3.2.  The representative of the United States repeated concerns raised in previous meetings. She further reminded the Committee that in March 2017, Russia had noted that the Eurasian Customs Union consultations on the draft technical regulation were scheduled for April. She asked that Russia provide an update on the outcome of those consultations.

3.3.  The representative of Ukraine repeated the concerns raised in previous meetings and supported the views of the EU and the US. In addition, she repeated requests for Russia to provide comments concerning the mandatory requirements for applicants to register in the territory of the Eurasian Economic Union. An update was requested on the results of the subsequent round of consultations on the draft technical regulation which Russia had flagged would be held in April 2017.

3.4.  The representative of Guatemala asked for an update on the internal consultations held in April 2017 and indicated her delegation's concern that the measure might become a barrier to trade.

3.5.  The representative of the Russian Federation repeated its statement made in previous TBT Committee meetings and announced that the next round of consultations would be held in July 2017. He added that Russia could not notify the draft technical regulation a second time since the procedures for drafting, adoption, amendment and cancellation of the EAEU technical regulations (adopted by Eurasian Economic Commission Council Decision No. 48 of 20.06.2012) set only one period for public consultations.

3.6.  The representative of the United States, referring to the EAEU Decision to allow only one comment period, recalled that the TBT Committee had agreed to a document on the coherent use of notification formats, which allowed for the revision of a document to be re-notified for an additional comment period. While the EAEU was not a Member of the WTO, Russia was. If there were substantial changes compared to the originally notified draft, Russia needed to submit a revised notification and reopen the comment period.

3.2.4.6  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 30511)

3.1.  The representative of the United States repeated concerns raised in previous TBT Committee meetings. She requested an update on the timeline for review and finalization of the amendments to K-REACH and, with respect to NIER's 11 May announcement on registration permitting alternatives to test reports, also asked which alternative data sources would now be accepted. She also expressed her delegation's willingness to continue last March meeting's discussions on: (i) Korea's indication that it would consider the US proposal to have an information-sharing DVC between US EPA and Korean regulators and industry; and (ii) Korea's indication that it would introduce a notification system for new substances in small volume, rather than a registration system, so as to minimize the burden on Korean and foreign companies.

3.2.  Recent Korean announcements had only added to concerns about the compliance burden, with many US chemical companies considering withdrawing from Korea's market – to the detriment of Korea's manufacturing sectors. There was also significant confusion and uncertainty – especially for trace amounts used as inputs – with respect to specific requirements and acceptance of notifications and registrations. Chemicals also continued to be added or removed from the toxic substances list without proper notice, opportunity for comment, or reasoning. In this respect, she asked whether Korea could provide answers to US industry recommendations such as that: (i) K-REACH focus on industrial chemicals; (ii) lubricants related to food and food production areas be exempted; (iii) Article 5 on "Duties of Business Entity" be removed so that the focus could be on implementing risk management provisions; (iv) IUCLID, or a compatible system, be used to ease registration; (v) QSAR (Qualitative or Quantitative Structure Activity Relationship Models) and

10 For previous statements follow the thread under IMS ID 332 (under dates raised and references).11 For previous statements follow the thread under IMS ID 305 (under dates raised and references).

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read-across techniques be accepted in order to reduce duplicative testing; (vi) a longer grace period for acceptance of existing chemicals; (vii) polymers of low concerns be exempted; (viii) the exemption confirmation requirement be removed, allowing self-certification; (ix) there would only be a simplified notification scheme required for novel and non-isolated intermediates; (x) there would be an exemption for substances used as stabilizers; (xi) consult with USEPA concerning its risk-based approach to endocrine disruptors; (xii) Korea would maintain a high level of CBI protection, as well as develop scientific, detailed guidance and uniform criteria for submitting CBI claims; (xiii) allow the use of generic names for non-hazardous substances; (xiv) Korea would establish a system for reporting directly from manufacturers, third parties or foreign companies, especially if substance concentrations need to be reported; (xv) K-REACH definitions and provisions would be aligned with Korea's biocide requirements, or use the Only Representative (OR) function similar to the EU process where the OR registers on behalf of foreign manufacturers rather than importers.

3.3.  The representative of the Republic of Korea said a summarized plan for K-REACH would be made available by the end of June 2017. Regarding registration system of chemical substances, to minimize the burden of Korean and foreign companies, he explained that Korea had introduced a notification system for new substances in small volume, instead of registration system. Moreover, substances in small volume for the purposes of R&D were already exempted from registration. On CBI (Confidential Business Information), if companies applied for confidential treatment of some information to the Ministry of Environment (MoE), such information could be protected under the CCA (Chemicals Control Act) and AREC after a review process by the MoE.

3.2.4.7  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 32812)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings. Concerning the review of Ministerial Decree No. 24, Indonesia had indicated that it was expected to be completed by the end of 2017. The EU asked Indonesia: (i) to ensure that the review was conducted in a transparent manner and allowed adequate opportunities for foreign toy manufacturers to participate; and (ii) to notify the draft amendment to the WTO at an early appropriate stage. The EU deemed the review urgent and necessary in order to address the issue of the currently discriminatory testing requirements, which tested every imported batch while testing domestic products every six months. This review should provide the same conformity assessment procedure for imported and domestic toys.

3.2.  The representative of the United States repeated concerns raised in previous TBT Committee meetings. Her delegation understood that the Indonesia was considering a new scheme for testing frequency. She requested an update on this review process and said that the new scheme should treat importers and domestic producers equally with respect to testing frequency. The US remained available for further discussion during the revision of the regulation.

3.3.  The representative of Japan expressed continued support for the positions of EU and US. Serious delays in exports were being caused by a sequence of events such as sampling, testing, SNI certification and pre-shipment inspection. Japan strongly requested again that Indonesia reconsider the requirements and accept testing results from foreign laboratories.

3.4.  The representative of Indonesia repeated responses provided in previous TBT Committee meetings. Concerning the different sampling method, Indonesia had an on-going process to determine the quantity of sampling units per number of products. Indonesia would recognize the test results of foreign conformity assessment bodies if accredited by national accreditation bodies signatory to APLAC and ILAC. Regarding acceptance at national level, Indonesia required a mutual recognition agreement with a regulatory authority. Indonesia remained available for further discussion.

12 For previous statements follow the thread under IMS ID 328 (under dates raised and references).

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3.2.4.8  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 34513)

3.1.  The representative of Argentina repeated concerns raised in previous TBT Committee meetings. Argentina's application remained blocked "in limbo" and despite the numerous requests made through the TBT Committee and bilaterally, the EU had not provided any legal justification for the lack of action by the European Commission for over five years. Argentina did not agree that the argument concerning a legal review of the use of traditional terms, announced more than three years ago, could legally justify the blocking of applications for the registration of traditional terms over such a long time-period. Due to the EU announcing over three years ago that it was in the process of reviewing the use of traditional terms with a view to simplifying them, all applications for approval of traditional terms had come to a standstill. Regulation (EC) No 607/2009 had therefore become obsolete, at least with regard to the requests for approval of "traditional terms". This meant that Argentina had been in a situation of legal uncertainty for three years on the reform of the wine regime, and for five years on its application for approval of the traditional terms "Reserva" and "Gran Reserva".

3.2.  The EU's refusal to apply its current standards while awaiting reforms which had never materialized reflected a lack of will in resolving this trade concern. The EU had indicated that the proposed reform would be notified in 2016 but this never materialized, nor was there any further information on the proposal or its impact on applications for approval, which Argentina had completed in full. In previous meetings, the EU had indicated that trading partners' concerns would be taken into account in the review that was under way. Argentina therefore again requested the EU to lift the unwarranted restrictions on Argentine exports of quality wine, by including this item on the agenda of the next meeting of the College of Commissioners and publishing the relevant act in its official journal. Argentina urged the EU to submit the proposed amendment to this regime without delay and to explain the treatment that would be given to applications that had completed the technical approval process, and requested the prompt conclusion of the formalities.

3.3.  The representative of the United States repeated concerns raised in previous TBT Committee meetings. US industry had lodged applications for the use of 13 traditional terms in 2010. She requested confirmation that the publication of the draft regulation was mid-2017 as had been indicated by EU officials and that the revised regulation would be notified to the WTO. She also asked if the regulation would enter into force in 2018 and to expedite the consideration of US applications. The EU had failed to provide any information on how US applications would be dealt with despite the advanced drafting stage of the revised regulation. She also asked the EU to explicitly detail the treatment for pending applications and to confirm that they were not required to wait until transitional provisions were put in place.

3.4.  The representative of Brazil supported concerns raised by Argentina and the US. He noted that EU regulations could cause problems for both Brazilian wine producers and MERCOSUR-EU negotiations.

3.5.  The representative of the European Union repeated statements made in previous TBT Committee meetings and showed availability for bilateral discussions with trade partners at expert level.

3.2.4.9  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 36714)

3.1.  The representatives of the United States, the European Union the Republic of Korea and Canada repeated concerns raised in previous TBT Committee meetings.

3.2.  The representative of India recalled that many of the issues raised had been previously responded to. On two issues, namely the acceptance of IECEE CB test reports and streamlining of procedures, he explained that BIS accepted IECEE CB test reports for critical components under the BIS Registration scheme. The IECEE Publication "IECEE 01" specified IEC Conformity Assessment

13 For previous statements follow the thread under IMS ID 345 (under dates raised and references).14 For previous statements follow the thread under IMS ID 367 (under dates raised and references).

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Systems - Basic Rules wherein the Legal Provisions of IECEE at National Level provided for the country law to prevail over any other obligation under IEC Conformity Assessment Systems. The acceptance of CB test reports and certificates had been discussed with IECEE officials in a meeting in October 2013, and in the joint communication issued both sides noted that India had not infringed any of the IECEE Rules. On streamlining of procedures, a provision had been included so as to allow for online acceptance of documents relating to the revision of IS 16046. Remaining queries and suggestions of Members would be transmitted to authorities in capital for consideration and response.

3.2.4.10  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 39315)

3.1.  The representative of Argentina repeated concerns raised in previous TBT Committee meetings. Argentina was particularly concerned that were the proposal on "criteria" alone to be adopted, the use of those substances whose exposure represented "insignificant risk" of endocrine disruption would be prohibited without any scientific justification. For Argentina, the adoption of a solely hazard-based approach instead of a full risk evaluation, which characterized hazards in all their elements (including risk exposure and characterization), could lead to disproportionate and unnecessarily trade-restrictive measures.

3.2.  Argentina recalled that the EU asserted that applications for import tolerances concerning marketing of plant protection products would depend on the approval of the proposal on repeals. Since this division was put in place, the internal treatment of the proposals had created great uncertainty around the approval of the provisions establishing repeals and hence import tolerances under Regulation (EC) No. 396/2005.

3.3.  Taking into account the impending expiry of the time limit fixed internally by the EU for the approval of this regulation, Argentina once more asked the EU to undertake an adjustment of its proposal in light of its international WTO commitments. Further, were the proposal on criteria to be approved in the terms presented by the EC, and without prejudice to the above-mentioned inconsistencies, Argentina asked the EC to advance the proposal on repeals "in parallel", in order to exempt at least those substances that represented insignificant risks to human health. Otherwise, not only would Members be faced de facto with a substantive modification of the proposal duly notified to the SPS and TBT Committees, but also with the unnecessary creation of increased barriers to international trade in agricultural products, without any scientific justification.

3.4.  The representative of Canada repeated concerns raised in previous TBT Committee meetings. Based on the most recent EU draft amendments, Canada awaited assurance as to if and when a complete risk assessment would be performed. Canada also stressed the importance of the EU ensuring that, regardless of the outcome of its internal regulations on these products, import Maximum Residual Levels (MRLs) would continue to be established according to scientifically based comprehensive risk assessments, in accordance with its WTO obligations.

3.5.  The representative of the United States repeated concerns raised in previous TBT Committee meetings. She noted that more than 20 Members at SPS Committee Meetings and more than ten in the TBT Committee had expressed serious concerns with EU's hazard approach for endocrine disruptors. She urged the EU to take into account these concerns, in particular that the EU should adopt a science-based approach that would evaluate the relevant risks.

3.6.  The representatives of Colombia and Brazil supported concerns raised by other delegations. Brazil, in particular, was interested to know why the EU separated the processes related to endocrine disruptors into two pieces of legislation: one about identification of endocrine disruptors and the other concerning the derogation of tolerance levels.

3.7.  The representatives of Thailand, Guatemala and Uruguay repeated concerns raised in previous TBT Committee meetings.

3.8.  The representative of Australia considered the retention in the measure of a risk-based derogation to be of critical importance to avoid unnecessary restrictions on critical crop protection products. Implementing the package without relevant derogation provisions could result in MRLs

15 For previous statements follow the thread under IMS ID 393 (under dates raised and references).

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being removed for a significant number of critical crop protection products, which would disrupt Australia's premium grain, oilseed and horticultural exports to the EU. Australia welcomed the opportunity to review and comment on the re-drafted exemption as soon as practicable to continue its engagement. Australia also noted that in June 2016 the European Commission had tasked the European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA) with reviewing registered active substances for the potential with which they may meet the new criteria for endocrine-disrupting properties. Australia asked the EU for an update on the status of this work and how the review outcomes would be communicated to trading partners.

3.9.  The representative of Egypt shared the concerns expressed by previous delegations and said that the draft regulation, if implemented as proposed, would potentially have negative impact on Egypt's trade with the EU given that it was expected to affect almost 50% of agricultural exports to the EU.

3.10.  The representative of the European Union repeated responses provided in previous TBT Committee meetings. She clarified that the relevant regulatory procedures to adopt the criteria were ongoing. During these ongoing discussions, and in order to address the comments received, the Commission had revised the draft acts to provide additional clarification regarding the burden of proof and the scope of the criteria. No substantial changes had been introduced compared to the drafts notified under the TBT and SPS Agreements. The revised versions of the criteria, as well as the state-of-play of the regulatory procedures, had been published on the Commission's website. For transparency reasons and to facilitate the decision-making process, which involved several bodies and institutions, the plant protection products act had been split in December 2016 into two acts: one text containing the "criteria" and another one containing the technical amendment to the clause on "negligible exposure". As there has been no substantial change in the content of the proposals, there was no need to re-notify the draft acts.

3.2.4.11  Peru — Act to Promote Healthy Eating Among Children and Adolescents, G/TBT/N/PER/59, G/TBT/N/PER/89, G/TBT/N/PER/89/Corr.1, G/TBT/N/PER/89/Add.1 (IMS ID 38316)

3.1.  The representative of Mexico repeated concerns raised in previous TBT Committee meetings and requested that Peru provide an update on the status of the draft technical regulations.

3.2.  The representative of the United States repeated concerns raised in previous TBT Committee meetings. In addition, she asked that Peru share information on regulatory developments and that US comments submitted on December 2016 be taken into account. She reminded Peru that sufficient time should be allowed for industry compliance before enforcement of labelling requirements.

3.3.  The representative of Guatemala repeated concerns raised in previous TBT Committee meetings and highlighted the lack of food labelling harmonization in the region, which affected in particular developing country Members and small and medium-sized enterprises that were unable to produce different labels for different markets.

3.4.  The representative of Peru repeated responses provided in the previous TBT Committee meeting. Trading partners had been given ample opportunity to submit comments with the deadline of 8 December 2016. Peru had taken comments into account in the final version of the regulations, which would be approved shortly and would enter into force 180 days after publication. He underlined that the regulations established time-frames for implementation of advertising and precautionary warnings requirements. The deadline for the latter would be calculated from the date of approval of their corresponding supplementary standards that would be published after adoption of the final regulations. Peru believed that these regulations were aligned with the TBT Agreement and fulfilled the legitimate objective of protecting citizens' health through improving consumer awareness of nutritional information. He reiterated that the measure was based on existing scientific evidence on non-communicable diseases developed by excessive consumption of sodium, sugar and fat. Based on this evidence, other Members had adopted similar measures. Peru affirmed that the regulations would be notified to the WTO when approved, in accordance with its WTO obligations.

16 For previous statements follow the thread under IMS ID 383 (under dates raised and references).

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3.2.4.12  Ecuador — Resolution No. 116 of the Foreign Trade Committee of Ecuador of 19 November 2013 and Technical Regulation of the Ecuadorian Standardization Institute RTE INEN 022 on the labelling of processed and packaged food products G/TBT/N/ECU/19 G/TBT/N/ECU/19/Add.1–11 (IMS ID 41117)

3.1.  The representative of Mexico repeated the concern with respect to this technical regulation, the objective of which was "to regulate and control the labelling of processed foods for human consumption, in order to guarantee a person's constitutional right to timely, clear, accurate and non-misleading information concerning the content and characteristics of these foods, thereby enabling consumers to make the correct choice when purchasing and consuming such products". She recalled that Mexico had submitted a communication to the TBT Committee on 19 January 2016 (G/TBT/W/430) expressing its trade concerns, and had raised the same issue as a specific trade concern at the November 2016 and March 2017 TBT Committee meetings.

3.2.  Mexico noted that during its bilateral meeting with Ecuador at the March 2017 TBT Committee meeting, Ecuador had stated that Technical Regulation 022 was undergoing a comprehensive review, and that some changes were planned in the following areas: (i) calculation of the sugar component of the graphic "nutritional traffic light" system, on the basis of added sugars; (ii) calculation of the content of permitted components and concentrations, to appear in units of mass; (iii) introduction of the graphic nutritional system for breast-milk substitutes; and (iv) introduction of rules on the size of warnings regarding transgenics and artificial sweeteners. She recalled that Ecuador had said that these changes would be notified to the WTO so that Members could submit comments, as required under the TBT Agreement. However, as far as Mexico was aware, this had not yet happened, and she therefore asked Ecuador about the current status of the review.

3.3.  In view of the above, Mexico requested that Ecuador: (i) provide an explanation on the reasoning and the scientific evidence justifying the use of the colour-coded graphic system for indicating the "high", "medium" or "low" concentration of total fats, sugars and salts, respectively, as well as information about the results of this scheme; (ii) provide justification for or, if appropriate, envisage the elimination of the requirement for the label to include the word "transgenic", where present; and (iii) reconsider the restrictions on advertising on labels.

3.4.  The representative of Colombia supported the concerns raised by Mexico, and requested an update from Ecuador on this measure.

3.5.  The representative of Guatemala repeated the concerns expressed at the previous meeting. In addition, Guatemala said the lack of harmonization of food labelling requirements in the region particularly affected developing countries and small and medium-sized enterprises, which were unable to produce different labels for different markets, and only benefited large enterprises.

3.6.  The representative of Ecuador repeated the explanations provided in the previous meeting.

3.2.4.13  Russian Federation — Safety of products for children and adolescents G/TBT/N/RUS/29 (IMS ID 41818)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings which were supported by the representatives of the United States and Ukraine. She asked for the planned date of entry of this measure into force.

3.2.  The representative of the Russian Federation explained that the EAEU Members had concluded the consultation process on draft amendments to the Technical Regulation. Unfortunately, the draft amendments №2 had not yet been adopted. His delegation expected that the adoption of amendments to the Technical Regulation would take place in July 2017, during the meeting of the Council of the Eurasian Economic Commission. Russia would keep Members informed of any outcome of that meeting.

17 For previous statements follow the thread under IMS ID 411 (under dates raised and references).18 For previous statements follow the thread under IMS ID 418 (under dates raised and references).

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3.2.4.14  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 42719)

3.1.  The representative of the United States thanked Thailand for the additional information provided through their TBT Enquiry Point in early March 2017 in relation to Thailand's regulation on the labelling and packaging for alcoholic beverages and noted the revised non-binding guidelines that had been published on Thailand's Ministry of Public Health website in April. While the US appreciated the efforts that Thailand had made to date to clarify its approach, including through the release of revised guidelines, the US found it difficult to understand and therefore also ensure compliance with many of the restrictions, such as on statements "leading to the cultural disgrace of country" or "false or exaggerated statements". This created considerable uncertainty for producers especially in light of the discretion that enforcement officers were granted under the regulation.

3.2.  At the previous TBT Committee meeting, Thailand had advised that they were undertaking an evaluation of the technical regulation. The US commended Thailand for acknowledging the need for the regulation to be evaluated and for considering improvements and asked for additional information about the process, including how stakeholders' concerns and experiences were being taken into account. The US welcomed the opportunity to share information on how US law achieved the important goal of protecting consumers from misleading labelling practices while providing certainty to producers about the applicable rules. The US understood that Thailand might be re-considering the implementation of pictorial health warnings for alcohol beverages. The US had expressed concerns about the draft requirements for such warnings that had originally been included in the regulation. She asked whether Thailand was considering introducing such requirements either as part of the re-evaluation of the technical regulation or otherwise. The US sought assurance that Thailand would notify any draft measures to the WTO so as to provide an opportunity for trading partners to comment and for those comments to be considered prior to finalization.

3.3.  The representative of the European Union said that they were following closely the developments and implementation of the Regulation on Criteria, Procedures and Conditions for Labels of Alcoholic Beverages (B.E 2558/2015), applicable from 19 October 2015. While regretting that the text of the regulation itself had not been amended, the EU welcomed the revised version of the technical implementing guidelines published at the website of the Office of the Alcoholic Beverages Control Committee in early April. As stated in previous TBT Committee meetings and in the written comments submitted in December 2015, which had not been answered by the Thai authorities, the EU was concerned with the strict labelling requirements included in the regulation and with the lack of clarity of the provisions relating to the messages permitted on the label, which might lead to inconsistent interpretations. The EU acknowledged that the revised technical guidelines seemed to provide certain clarifications, for instance, on the use of true and factual statements or statements supported by evidence. However, the EU noted that they prohibited claims about properties, benefits or quality of the alcohol products whether directly or indirectly, and that this prohibition would have an impact on certain specific terms commonly used in the EU linked to the ageing or maturation process and to the conditions or characteristics of the product. The guidelines also prohibited statements that encouraged the consumption of alcohol. While the EU shared concerns linked to the protection of consumers, further clarification would be needed on the specific requirements envisaged by Thailand, so as to avoid undue impacts on trade and divergent interpretations.

3.4.  In light of the above, the EU considered that the revised guidelines were still unclear and did not provide industry with concrete information on how to ensure that labels of alcoholic drinks were compliant with the Thai regulation. The EU invited Thailand to further clarify the implementation of the regulation and encouraged the involvement of stakeholders in the process, since they did not seem to have been consulted during the recent revision of the technical guidelines. The EU also asked for an update on any possible upcoming initiatives with regard to graphic health warnings on alcoholic drinks. Should there be any such initiative, the EU invited Thailand to notify any draft proposal, so as to allow Members to become acquainted with it and submit comments, in accordance with Article 2.9.2 of the TBT Agreement.

3.5.  The representative of Japan shared the concerns raised by other delegations. At the previous TBT Committee meeting, Thailand had said that a technical document for this regulation had been

19 For previous statements follow the thread under IMS ID 427 (under dates raised and references).

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developed and would be published in early April 2017. Japan asked Thailand to provide an update on any discussions on the revision of the measure.

3.6.  The representative of Australia repeated the concerns expressed at the previous meeting.

3.7.  The representative of Guatemala repeated the concerns expressed at the previous meeting, and welcomed any action that would be taken by Thailand in response to the trade concerns that Members continued to raise as well as to the request by some Members to suspend the measure.

3.8.  The representative of Canada said that his delegation had expressed interest and concerns regarding the regulation during a number of Committee meetings. In particular, Canada believed that the labelling requirements were likely to impose discriminatory treatment on like alcoholic products and result in additional labelling costs for exporters to Thailand. Therefore, the measure would have a negative impact on trade. Canada requested that Thailand provide an update to the Committee in order to reduce uncertainty for exporters.

3.9.  The representative of New Zealand said that her delegation acknowledged and supported Thailand's right to introduce new regulations to address specific public health concerns. In seeking to address the harmful use of alcohol, the technical regulation was directed toward achieving a legitimate public health objective. New Zealand thanked Thailand for its engagement on the regulation to date and for the updates it had provided. As expressed in previous meetings, New Zealand continued to follow the development of the measure with interest, particularly with regards to its potential impact on trade. She sought an update on whether Thailand intended to introduce mandatory graphic health warnings on alcohol labels and if so, when Thailand expected to notify this to the WTO.

3.10.  The representative of Thailand reaffirmed its intention to control the harmful use of alcohol through various measures. The regulation in question aimed to control new consumers of alcohol, especially adolescents and women as Thailand did not want its new generation to be attracted by misleading messages labelled on alcoholic beverages. It was widely recognized that the label of alcoholic beverages was regarded as one of the advertising and marketing tools for use at the point of sale. There was no doubt that advertising of alcoholic beverages would increase alcohol consumption and consequently its harmful use. Harmful use of alcohol created many health and social problems as presented in many studies. The technical regulation did not aim to create technical barriers to trade. It simply prohibited the use of falsified, exaggerated, misleading messages that attracted the consumer to the product, and socially disruptive messages on labels and packages of alcoholic beverages. Thailand understood the concerns in this respect and had revised the technical document, which explained each prohibited practice and clarified unclear messages. The revised version was accessible via the website of the Office of Alcohol Beverage Control Committee since April 2017. Thailand was in the process of evaluating the implementation and impact of the regulation and hoped to share the result of the evaluation with the Committee by 2018. Thailand reiterated its commitment to comply with international trade agreements while retaining its right to protect the health of its population.

3.2.4.15  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 42820)

3.1.  The representatives of the European Union and the Republic of Korea repeated concerns raised in previous TBT Committee meetings.

3.2.  The representative of Canada said that the requirements, under Article 13 of Order No.4 and Article 15 of Order No.5, for imported medical devices to obtain market approval from the country (region) where the applicant's business registration was or where the product was produced would restrict access for products not registered in the country of origin, creating unnecessary barriers to trade while further limiting Chinese consumers' access to life-saving and life-improving medical devices. Canada wished to work with China with a view to addressing these and other aspects of the regulation in a constructive manner.

3.3.  The representative China said that since there was no update delegations could refer to the minutes of the previous meetings, during which China had provided detailed explanations.

20 For previous statements follow the thread under IMS ID 428 (under dates raised and references).

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3.2.4.16  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/23, 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 44221)

3.1.  The representative of the United States supported the public health objective of the Gulf Cooperation Council (GCC) of working to curb excessive caffeine consumption but requested again that the GCC and GSO take into account the feedback from the private sector in developing final regulations. The US had submitted comments in 2015 and 2016, and requested that consideration be given to its remaining concerns, in particular regarding size and content of the warning labels, as well as container size limitations. In addition, the US requested information on what concerns the GCC had identified with regard to energy drinks and technical information supporting the regulation of these products. The US understood that these regulations were still in development and requested any additional information Saudi Arabia could provide on the status of the regulatory process. The US remained available for further discussion.

3.2.  The representative of the European Union repeated the concerns raised in the previous minutes.

3.3.  The representative of Switzerland supported other Members' interventions and expressed concern on the trade impact of the measures that GCC countries were developing in the area of energy drinks. He recalled that under the TBT Agreement technical regulations should be based on international standards when they existed and not be more trade restrictive than necessary. Switzerland shared GCC's public health objective and regulated these beverages based on international standards on nutritional labelling and health claims. He noted that the European Food Safety Agency found the level of protection of health of energy drinks to be safe and failed to understand the conclusion of GCC members to go beyond Codex guidelines and to require producers to warn consumers about allegedly detrimental effects of specific consumption quantities or for certain groups. Switzerland lacked scientific evidence to back up these warnings and said that there were alternatives based on international standards and WHO recommendations such as information campaigns on the advantages of a balanced diet and of a healthy lifestyle. It remained unclear to what extent the GSO standard was applicable in other GCC countries and its relation with national measures on energy drinks in GCC countries. Switzerland had submitted comments in 2015 and 2016 and requested that consideration be given to them by the GCC and GSO. His delegation asked GCC countries for an update on regulatory developments.

3.4.  The representative of the Kingdom of Bahrain, on behalf of the GCC, stated that the regulation was still being drafted by the Gulf Technical Committee for food and agriculture standards. This committee was still receiving comments and amendments from concerned Members. GCC countries remained available for further discussion.

3.2.4.17  European Union — Common Criteria for Information Technology Security Evaluation (Common Criteria) certification in the EU (IMS ID 44822)

3.1.  The representative of China reported that since 2009, many Chinese companies had applied for Common Criteria EAL 4+ certification in some EU member States. The labour and financial costs of applying for this certification were quite large, however none of the companies had been able to obtain the certification, and their applications to join JHAS had also been refused. China said that Article 5 required the equal treatment of foreign products, and the least trade-distortive effect in respect of conformity assessment procedures. China hoped that the EU would provide national treatment to Chinese companies and products in respect of certification and joining standardizing bodies. Finally, China asked the EU to increase the transparency of JHAS standards, and provide more Common Criteria related information, such as the organization of CCRA, SOGIS, JHAS, and their relevant work and functions.

3.2.  The representative of the European Union said that, unlike in China, in the EU commercial encryption and encryption for national security were clearly distinguished. Encryption for national

21 For previous statements follow the thread under IMS ID 442 (under dates raised and references).22 For previous statements follow the thread under IMS ID 448 (under dates raised and references).

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security was limited to a few sectors closely linked with national security matters. Neither the EU nor its member States imposed mandatory cryptography standards or conformity assessment procedures to access the EU markets. He said it was up to individual companies to ensure secure transmission of data over their systems and networks.

3.3.  The representative explained that European certification schemes were voluntary and based on international standards for security evaluation (in particular, the Common Criteria standard ISO/IEC 15408, an international standard since 1999) and global practices, such as the Common Criteria Recognition Arrangement (CCRA – international scheme) and SOGIS-MRA (Senior Officers Group for Information Systems, Mutual Recognition Agreement – European scheme, EU Member States plus EFTA countries). The EU clarified that ICT security certification was a member State competence, and the security testing laboratories operated under the oversight of the national certification bodies established by EU member States. On these bases, the EU considered that these measures fell outside the scope of the TBT Agreement. The EU delegation had repeatedly asked China to identify concrete measures, technical regulations or conformity assessment procedures, falling within the scope of the TBT Agreement.

3.4.  The EU was of the view that regulatory approaches should not prevent authorities and IT system operators to use the best technology available, regardless of ownership of technology or location of equipment manufacturers. He clarified that while in China no foreign company had ever been granted a licence by OSCCA, some Chinese companies had obtained certification up to Evaluation Assurance Level (EAL) 4, which was high in the evaluation scale under the common criteria in international standards. He said that the JIL Hardware Attack Subgroup was not a standards body, but a subgroup composed of EU member State experts set up under the Senior Official Group on Information Systems Security (SOG-IS). The SOG-IS comprised only nine member States along with Norway and dealt with information security issues - those member States who were fully participating in the Common Criteria Recognition Agreement. Finally, while Chinese stakeholders could participate in the activities of European standardization bodies in information security, some European companies had difficulties in participating in the activities of Chinese standardization bodies, such as the Technical Committee 260 (TC260).

3.2.4.18  China — Administrative Measure on Cosmetics Labelling (AMCL) G/TBT/N/CHN/1064 (IMS ID 45623)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings.

3.2.  The representative of Japan repeated three concerns such as manufacturer labelling in Articles 14 and 15 of the draft measures, promotional advertising of cosmetics efficacy claims in Article 19 and 20 of the draft measures and providing clear guidance raised in previous TBT Committee meetings. He noted that, at the Committee's June meeting, China had mentioned that the draft AMCL would be revised according to the contents of "Regulations concerning Hygiene Supervision over Cosmetics" which was a superior regulation to the draft measures. Japan asked China to provide opportunity for public comment on the revision in accordance with WTO/TBT rules and encouraged China to explain the details of discussion on manufacturer labelling and efficacy assessment testing in the studies.

3.3.  The representative of New Zealand repeated concerns raised in previous TBT Committee meetings. New Zealand encouraged China to ensure that these measures did not create unnecessary barriers to trade. In that respect, New Zealand also asked for clarification on whether animal testing for the safety of cosmetic products would continue to be required for imported cosmetic products if safety could be provided through accepted alternative methods. It was noted that mandatory animal testing requirements for domestically manufactured cosmetics had been removed in 2014, and New Zealand encouraged China to ensure that imported cosmetics products would not be treated less favourably than domestic products in this respect.

3.4.  The representative of China said that cosmetic labelling was quite important for Chinese consumers and that the regulation was still under drafting. China had collected many suggestions and comments from enterprises and/or associations both in the domestic market and abroad. These were being studied carefully and reasonable suggestions and comments would be absorbed. Following international practice, China would allow the imported products consistent with China's relevant regulations to be attached with labels in Chinese.

23 For previous statements follow the thread under IMS ID 456 (under dates raised and references).

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3.2.4.19  China — Registration Fees for Drugs and Medical Device Products (IMS ID 46624)

3.1.  The representative of the Republic of Korea repeated concerns raised in previous TBT Committee meetings. In addition, with regard to Class II medical devices, while China provided for public registration fees for imported devices, registration fees for domestically manufactured devices were to be set by each provincial government without any further information. In this regard, Korea requested China to at least publish the registration fee criteria applied by Chinese provinces on Class II to domestic medical devices.

3.2.  The representative of Canada repeated concerns raised in previous TBT Committee meetings. She said China's recently announced Circular on Streamlining and Regulating a Batch of Administrative Service Fees and the abolition of 41 administrative fees was an encouraging development.

3.3.  The representative of Australia repeated concerns raised in previous TBT Committee meetings.

3.4.  The representative of China reiterated the response provided in previous TBT Committee meetings. Registration fees for drugs and medical devices were common practice internationally and the registration fees in China were calculated on the basis of cost. The difference between the drugs and medical devices only reflected the different workload and pricing levels. China continued to be of the view that registration fees should not be discussed in TBT Committee.

3.2.4.20  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 47025)

3.1.  The representative of the European Union thanked the Brazilian authorities for their reply of 22 May 2017 to the EU comments of 18 July 2016. The EU appreciated that many of their comments had been taken into account, in particular that Annex II had been removed from the draft ordinance and that other comments with relation to the year of harvest, limitations to sparkling wine production, definition of spirit drinks and definition of sangria had been entirely or partially incorporated into the revised draft. Nevertheless, some of the EU concerns had not been reflected in the revised draft ordinance, in particular in relation to the various limits set out in the annex that were not in line with OIV standards and also regarding, inter alia, indication of the colour and the sugar content on the label, use of the term "moscato", sugar content in liqueurs and definition of aromatized wines. The EU took note that not all comments could be taken on board in the revised draft ordinance since some of the respective provisions were based on higher level laws and regulations. However, there was willingness on the Brazilian side to consider addressing some of them in the future and the EU was prepared to work bilaterally with Brazil in this respect. Finally, the EU welcomed the intention of the Brazilian authorities to hold a public consultation on the revised text towards the end of June, which would provide an additional opportunity for an exchange of views on the draft ordinance.

3.2.  The representative of Brazil stressed that the process relating to this ordinance was being conducted with openness and transparency. All comments had been taken into consideration, a public consultation had been held the previous year and agricultural authorities would hold a public consultation from 27 to 30 June 2017. Brazil was following through all relevant provisions of the TBT Agreement and looked forward to working further with the EU on this matter.

3.2.4.21  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 47826)

3.1.  The representative of the European Union thanked Brazil for clarifications provided at the March 2017 Committee meeting concerning various aspects of INMETRO's Ordinance No. 563 of 29 December 2016, in particular as regards the implementation timeline and the certification process. While the EU understood the rationale behind the measure, which was to increase the traceability of toys and facilitate recall of toys in case of safety issues, the requirement on the registration of individual toys with INMETRO according to the concept of product family continued

24 For previous statements follow the thread under IMS ID 466 (under dates raised and references).25 For previous statements follow the thread under IMS ID 470 (under dates raised and references).26 For previous statements follow the thread under IMS ID 478 (under dates raised and references).

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to be the main concern for European toy manufacturers. He reiterated the concerns raised in previous meetings.

3.2.  The representatives of Canada and the United States echoed the concerns raised by the EU. Canada repeated the statements that had been previously delivered by her delegation on this measure.

3.3.  The representative of Brazil stressed that the preparation of this measure had been undertaken in an open and transparent manner. Comments from Members had been taken into account and had led to the removal of the filming requirement. Two public consultations had taken place in 2014. He confirmed that implementation guidelines would be made available to help producers comply with the law. This registration requirement also applied to 69 other products with which there did not appear to be any issue. Nevertheless, Inmetro had created a working party specifically on toy registration. This register would guarantee the traceability and provide additional information to consumers and was in line with internationally approved market surveillance benchmarks. INMETRO had met with representatives from the toy industry and was willing to meet with them again if necessary.

3.2.4.22  China — Interim Measures for Quality Management of Commercial Coal, (IMS ID 47727)

3.1.  The representative of Australia repeated concerns raised in previous TBT Committee meetings. Retesting of coal in China was causing significant delays for Australian exports and adding greatly to the cost of trade. She stressed that Australian testing facilities were equipped to accurately test for quality and purity standards, and that Australian coal exceeded these high standards.

3.2.  The representative of China said that the measure at issue came into force in January 2015 and, since that date both imported coal and domestic coal were required to satisfy the same standards.

3.2.4.23  India — The Stainless Steel Products (Quality Control) Order, 2015 (IMS ID 48628)

3.1.  The representative of the European Union repeated concerns expressed at the previous meeting. Given the low risk of the steel products subject to certification, and that EU steel producers already complied with internationally recognised standards for safety and quality recognized around the world, the EU again requested that India: accept tests carried out in foreign accredited laboratories attesting compliance with ISO standards (or India standards) thus not requiring local testing in India for all types of steel products; and not conduct factory inspections of EU steel mills with quality management systems (QMS) as defined in ISO 9001 in place. Finally, recalling the bilateral meeting with India on the margins of the March 2017 meeting, the EU reiterated its request for additional information about the reasons for the low number of licences being issued to the EU manufacturers.

3.2.  The representative of India recalled that the Quality Control Order aimed to ensure quality and durability of stainless steel products intended for critical end-use applications. He noted that many of the steel products were also used as final products. The order was equally applicable to both domestic and foreign manufacturers. Regarding concerns about the necessity of the measure, India reiterated that quality of the stainless steel was of utmost importance as it involved public health, safety and security. For the requirement of testing, India stated that the BIS (Certification) Regulations 1988, required evidence of conformity of the product to the relevant Indian standard through testing in a BIS/BIS-recognized laboratory, for the purpose of granting a BIS marks certification licence. Samples were drawn for testing in the independent laboratories for assessing conformity to the relevant standard before granting a licence. Indian standards specified the method of tests, and the labs recognized by BIS carried out tests as per the test methods and requirements defined in Indian standards.

3.3.  With respect to the cost of certification, India informed the Committee that testing charges for samples were part of the annual marking fee for operating the licence, and said that the BIS certification cost was reasonable. Concerning the suggestion that steel mills with ISO 9001 quality

27 For previous statements follow the thread under IMS ID 477 (under dates raised and references).28 For previous statements follow the thread under IMS ID 486 (under dates raised and references).

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management system in place be exempted from the requirement of factory inspections, India stated that product certification was different from QMS certification. The visit to the factory premises and verification and testing in the factory, was part of the BIS Conformity Assessment Scheme. On the other hand, he noted that ISO 9001 certification did not cover factory testing as per Indian standards. Finally, India informed the Committee that the Indian standard on stainless steel plate, sheet and strip, referred to in the Quality Control Order, was revised from IS 6911:1992 to IS 6911:2017. In this revision, 21 new grades of stainless steel had been incorporated.

3.2.4.24  India — Draft Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2015, G/TBT/N/IND/51 (IMS ID 49429)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings. He requested confirmation that comments provided by the EU had been taken into account in the revised draft regulations covering standards and additives for alcoholic beverages. The EU understood that this text had been sent for ministerial approval and that its publication in the Gazette was expected in June 2017.

3.2.  The representative of Japan shared the concerns of the EU. While Japan's comments had been replied to by India, it had been difficult to assess from the reply whether the comments had been taken into account. He therefore asked India to provide a consolidated draft text.

3.3.  The representative of Canada asked India when the standard would enter into force. While Canada appreciated the update provided by India at the previous Committee meeting, it hoped to see a similar definition for Canadian whisky, like other whiskies, as a whisky distilled and matured in Canada in accordance with the laws applicable thereto in Canada.

3.4.  The representative of India referred Members to replies provided in the previous meetings of the Committee. Following the March TBT Committee meeting, the Indian delegation had forwarded the written replies from FSSAI to concerned delegations. There had been no further update since then. He believed all questions raised had thus been responded to and asked that concerned Members forward their remaining questions in writing.

3.2.4.25  China — Formula Registration Regulation for Infant and Follow-up Formula, G/TBT/N/CHN/1165 (IMS ID 49330)

3.1.  The representatives of the European Union and Japan repeated concerns raised in previous TBT Committee meetings.

3.2.  The representative of the United States supported the EU's concerns and sought to ensure that trade would not be disrupted as a result of Decree 26, and hoped to gain full understanding of the measure. The US had recently provided comments on the implementation of CFDA Announcement 175. The US asked the implementation date for this measure and whether China had feedback on US comments. The US kindly requested China to notify this measure to the WTO. She recalled that at the March 2017 TBT Committee meeting, China had indicated that the purpose of limiting the number of products on the market under Decree 26 was to avoid "consumer confusion" and "deceptive trade practices". The US asked China to explain what consumers were confused about and what the deceptive trade practices were. She also recalled that China said that infant formula was designed to be a replacement for breast milk and that there should not be many formulations available. The US requested the basis for this position.

3.3.  The representative of China reiterated that the huge domestic demand and rapid development of the infant formula milk powder industry as well as the challenges of market disorder had led to consumer confusion caused by too many brands and formula on the market. China said infant formula should only be a nutritional supplement to breastfeeding, that the composition of infant formula milk powder should be similar to breast milk, and that there should not be too many kinds of formula. China's research had concluded that large foreign infant formula manufacturers had no more than three brands. To address Members' concerns on on-site inspection, China clarified that it mainly focused on the R&D data of milk powder formulas and manufacturers' capacity to turn formulas into production. Her delegation emphasized that the regulation was applied in a non-discriminatory manner and that a transitional period had been provided to avoid unnecessary trade distortions.

29 For previous statements follow the thread under IMS ID 494 (under dates raised and references).30 For previous statements follow the thread under IMS ID 493 (under dates raised and references).

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3.2.4.26  Indonesia — Halal Product Assurance Law No. 33 of 2014 (IMS ID 50231)

3.1.  The representative of the European Union repeated concerns with the Indonesian Halal Product Guarantee Law. A clearer idea of the specific products covered by the law was necessary for Members as the lack of transparency on implementing rules and the fragmented approach created uncertainty as to the requirements applicable at any point in time. The European Union asked for an update on the development of implementing provisions on halal and the timing for adoption, reminding Indonesia of their transparency obligations.

3.2.  The representative of the United States repeated concerns raised in previous TBT Committee meetings.

3.3.  The representative of Brazil supported the concerns raised by the EU and the US. Given the profound impact this measure would have on international trade, he asked Indonesia when this measure would be notified to the WTO and whether there would be an opportunity to provide comments.

3.4.  The representative of Australia repeated concerns with the Indonesian Halal Product Guarantee Law. To date, Australia had still not received a response to its request for clarification on some aspects of the regulations including on the requirement for certification or labelling of non-halal product; the very broad coverage of the regulation extending to consumer goods and services; and the treatment of existing halal certification assurance systems.

3.5.  The representative of Indonesia stated that the Halal Product Assurance Law was scheduled to be applicable in 2019 when all related products being distributed and sold would require halal certification. The rules of procedure were currently being developed between ministries and the implementation regulation would be equipped with a number of ministerial regulations for the ministry of religious affairs to review specific matters. The harmonization aimed to ensure that the review was undertaken without overlapping with existing rules. This law did not prohibit the sale and circulation of non-halal products, it provided certainty to consumers about the halal products by clearly indicating which products were halal and which were non-halal, and allowed consumers to choose freely. Indonesia remained available for further discussion with interested Members.

3.2.4.27  Thailand — Milk Code - Draft Act on Controlling to the Marketing Promotion on Food for Infant and Young Children and Other Related Products BE, G/TBT/N/THA/471, G/TBT/N/THA/471/Rev.1 (IMS ID 50332)

3.1.  The representative of the United States strongly supported the public health objective of increasing breast feeding, and her delegation acknowledged receipt of the revision to the measure, which included a welcome modification, allowing advertising of food for young children. Both the US government and the US industry planned to submit comments on the revised measure through Thailand's Enquiry Point. The US understood the Committee on the Control of Marketing of Infant and Young Child food had been granted substantial authority, including developing a system for monitoring the marketing of foods for infants, young children and supplementary food for infants and providing advice to the Ministry of Public Health to ensure compliance with the measure. She mentioned that the US comments would address questions on the broad definition of foods for young children and the Marketing Committee's work to ensure compliance with the measure. Her delegation welcomed any comments or feedback from Thailand on the scope of the Marketing Committee's work.

3.2.  The representatives of Australia, the European Union and Canada repeated and supported others concerns raised in previous TBT Committee meetings.

3.3.  The representative of Thailand explained that the draft Milk Code had recently been modified, and Thailand had notified the second revision to WTO Members in April 2017, which reflected its transparency and sincerity for Members to have opportunities for comments and feedback. The exact timeframe for enforcement was to be confirmed. His delegation understood that the industries needed sufficient time to adjust their practices, so the draft Milk Code provided an appropriate transition period for any measures. A Marketing Committee would be established under this draft act to ensure effective enforcement. Various stakeholder representatives would be engaged as Committee members. The representative informed that Thailand had been using

31 For previous statements follow the thread under IMS ID 502 (under dates raised and references).32 For previous statements follow the thread under IMS ID 503 (under dates raised and references).

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Codex as its guide to develop its quality and safety standards for food including milk products, and ensured that the application of these guidelines did not contradict with Codex. He emphasised Thailand's need for this draft act to control the marketing promotion of milk products that were specifically marketed for infants and young children in order to protect breastfeeding practice of mothers and children, as breastfeeding provided great lifelong benefit for them. Thailand welcomed comments and support from Members to help Thailand achieve the goal on breastfeeding according to global target by 2025.

3.2.4.28  Russian Federation — Rules of cement certification, G/TBT/N/RUS/48, G/TBT/N/RUS/49 (IMS ID 49733)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings. She recalled that her delegation had already raised this issue during the Council on Trade in Goods (CTG) of 17 November 2016. The EU expressed particular concern with Russia's continued adoption, prior to notification, of restrictive, disproportionate and unjustified measures before their entry into force. Since the introduction of the mandatory certificate for cement, in March 2016, no importer had been able to ship cement to Russia (excluding those of white cement which was not produced in sufficient quantities in Russia). The EU therefore called upon Russia to inform its customs that valid certificates could not be rejected at the border, and to ensure that the EU exporters would no longer face unjustified refusals at the border.

3.2.  She also noted that at the end of January 2017 Russia had adopted an amendment of the Russian mandatory standard for cement GOST R 56836-2016, which introduced additional obstacles to importers to import cement in Russia. The EU requested Russia to provide an official copy of this amendment to WTO Members. Furthermore, the EU called upon Russia to notify to the WTO the amended GOST with sufficient time before its formal adoption and entry into force to allow a proper discussion. The amended GOST, in her delegation's opinion, created additional obstacles on importation. Among the new requirements, the EU highlighted the following ones: (i) the extension from 10 working days to 30 days for the response to an application for a conformity certificate; (ii) the requirement for a separate certificate for each type of cement; (iii) the requirement, for importers only, that at the border one shipment was defined by one type and quality of cement, and had to be tested according to the relevant standard. This requirement, she said, was extremely burdensome and represented a de facto ban due to the impossibility of storing at the border a train composed of more than 50 wagons for 28 days, a time period necessary to do the testing. Still with respect to this particular requirement, she then asked Russia to confirm whether the strength test had to be conducted at the border and explain why it was necessary for importers to do all this testing given that domestic producers were not subject to the same strict control; (iv) the requirement to have the quality of cement producer proven and confirmed by a non-identified authority. With respect to this particular requirement, she then asked Russia to specify who would conduct this control and how Russia would ensure that such checks would be done in an efficient and timely manner; (v) the requirement that only few conformity assessments bodies were accredited to issue certificates. With respect to this particular requirement, she then asked if Russia could provide guarantees that there would be sufficient number of bodies and those would have the capacity to issue the necessary certificates to importers, given that this was important because a number of the biggest bodies refused the applications of importers on the basis of lack of resources to conduct the assessment; and, finally, (vi) with respect to business confidential information (BCI), she asked Russia to confirm that it would not require BCI in the conformity assessment procedure, in particular pursuant to point 6.3 of the GOST.

3.3.   The EU also reiterated its request for Russia to suspend all evoked measures that led to a de facto ban of EU-originating cement imports, to justify the additional testing processes at the border for each cement batch exported to Russia by the EU in light of the TBT rules. The EU also asked Russia to confirm that the strength test would not have to be performed for certified cement, as this would lead to the product being blocked at the border.

3.4.  The representative of Mexico repeated concerns put forth in previous meetings. She noted that her delegation believed that Russia may be infringing Article 5.1.1, 5.1.2 and 5.2.1 of the TBT Agreement by applying the conformity assessment procedure established in the measure in a manner more burdensome for imported cement than for domestic cement and that from Eurasian countries. She reiterated the concern that Russia may be failing to ensure that assessment procedures were undertaken and completed as expeditiously as possible.

33 For previous statements follow the thread under IMS ID 497 (under dates raised and references).

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3.5.  The representative of Ukraine repeated concerns raised in previous TBT Committee meetings.

3.6.  The representative of Kazakhstan stated that Kazakhstan and Russia were very close trading partners and founders of the Customs Union. He expressed his delegation's regret that they had to join others in raising concerns. Cement producers were experiencing serious problems in accessing the Russian market due to these measures. Kazakhstan was specifically concerned with the unsubstantiated refusal to issue certificates for conformity and delays in their issuance. When applying for certificates of conformity before the Russian bodies, Kazakhstan's applicants were placed at the end of the queue for the season of sales of cement, regardless of early or late submission of application. This was incompatible with Article 5.2.1 of the TBT Agreement. Kazakhstan asked that Russia provide non-discriminatory treatment for Kazakhstan's products in comparison to Russian domestic products and other domestic products in terms of conformity assessment procedures for cement.

3.7.  The representative of the Russian Federation explained that the requirement for mandatory certification of cement in Russia was due to the urgent problems stemming from dangers to life and health; problems that were directly due to the content of a carcinogen and, indirectly, also due to the quality and reliability deterioration in buildings and constructions. For inspection control, he explained that the rules of cement certification provided for two forms thereof: (i) inspection control at a production site; and (ii) inspection control of the products on the border. Inspection control at a production site presumed a complex control of the production, which was conducted no less than once every six months, and additional inspections on unscheduled basis. Control of products was a simpler, less costly procedure.

3.2.4.29  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 50534)

3.1.  The representative of the United States, the European Union, Ukraine, Canada and Australia reiterated concerns raised in previous TBT Committee meetings and supported the concerns raised by other Members.

3.2.  The representative of Turkey repeated concerns raised in previous TBT Committee meetings. The requirements of the measures were clearly disproportionate so as to prevent exportation to Egypt and were creating distortions to trade flows, introducing barriers to trade and acting as a quantitative restriction.

3.3.  The representative of Switzerland said it was still unclear how Decree No. 43/2016 would contribute to the objective of Egyptian authorities and whether the circumstances giving rise to the adoption of these measures still existed. The lack of clarity of the registration process, the requirements to be fulfilled and the actual implementation of the measures continued to be of concern. It still remained unclear how applications were evaluated and if the completion of the process was subject to any time limit. Switzerland therefore encouraged Egypt to consider a less trade-restrictive approach to bringing its legislation and implementation into compliance with the principles and rules of the WTO and TBT Agreement.

3.4.  The representative of Thailand said this measure had begun to affect Thai exports to Egypt and looked forward to meeting bilaterally.

3.5.  The representative of Egypt explained that the decree required the registration of the manufacturing plants and companies owning trademarks qualified to export their products to Egypt. This measure, however, did not deal with, or require, compliance of products with specific technical regulations. This decree was therefore administrative in nature and, as such, did not impose further burdens on producers or companies to comply with specific technical regulations. Although Egyptian imports from the products listed in the decree represented only a minimal share in total Egyptian imports, the Egyptian market had been witnessing within the last few years a sharp increase of imports of such products. This sharp increase was due, however, to illegal manufacturing practices, which were having a negative impact on consumers' health and safety. Egypt also confirmed that Egyptian manufacturing plants and companies were also subject to registration, surveillance and inspection requirements by numerous Egyptian regulatory authorities in order to ensure their compliance with relevant regulations. On the issue of whether the quality certificates were deemed to be sufficient for registration, Egypt confirmed that any certificates were issued by entities accredited by national or regional accreditation bodies (ILAC) or (IAF), or an

34 For previous statements follow the thread under IMS ID 505 (under dates raised and references).

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Egyptian or foreign governmental entity approved by the competent minister. Copies of these certificates were also accepted, given that the Egyptian authorities could access an electronic version thereof on the database of the accredited certification service providers. Further, registration fees were payed only once for the manufacturing plants and the companies owning trademarks. Moreover, registration remained valid as long as the quality certificate was valid. Registration duration was largely depending on manufacturers submitting the full file, including all data and required certification.

3.6.  She expressed her delegation's strong belief that the registration requirements under Decree No. 43/2016 were not more trade restrictive than necessary. Since the full implementation of the decree, hundreds of producers and manufacturers had been registered and no company registration request had been refused to date. All concerns and requests raised on these measures had been conveyed to capital, where some were still being examined due to privacy concerns. She stressed her delegation's intention to fully cooperate and its commitment to tackle all concerns raised by Members.

3.2.4.30  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 51935)

3.1.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings. In addition, he welcomed the news that during the revision process of the standard, the EAC had removed some of the problematic provisions, in particular those regarding analytical parameters. The EU welcomed this step in the right direction. He also invited Uganda and Kenya to explain the process foreseen in order to incorporate these standards into the appropriate technical regulations. In this regard, the EU encouraged all EAC members to adopt the standard in a harmonized way as national deviations from the regional standard would create additional barriers to trade. Lastly, he recalled that the minimum time for the entry into force of the new technical regulations should be at least six months, and encouraged EAC members to provide an even longer transition period to allow companies to adapt to the new requirements.

3.2.  The representatives of the United States thanked Kenya, Tanzania and Uganda for their recent notifications of draft alcohol beverage standards that sought to implement revised East African Community (EAC) standards. The US urged Rwanda and Burundi to also fully notify these alcohol standards to the WTO if they intended to adopt them, and to provide an opportunity for comment prior to finalization. The US appreciated the opportunity that these notifications provided for WTO Members to submit comments, but was concerned that Kenya's plan to adopt the standards in June 2017 so shortly after the comment period closed provided very little time for review and revision. The US asked Kenya to confirm whether this was the correct timeline and, if so, whether further revisions were possible.

3.3.  The US appreciated the efforts that the EAC countries had made to revise the draft regional EAC alcohol standards following comments from the US and other WTO Members. She noted that in a number of areas their comments had been taken into account positively.

3.4.  That said, there were still a number of outstanding concerns that were more fully set out in their written comments. In this respect she highlighted: the overly restrictive list of permitted additives for wines which did not include many additives that are commonly permitted in major wine-producing countries; and, the lack of clarity about the kinds of whiskies that may be sold in the EAC. The US urged Kenya and its EAC partners to delay national adoption until these concerns had been resolved, otherwise US trade would be impacted. The US supported the EAC's efforts to protect its citizens and reduce the impact of the consumption of adulterated alcoholic beverages. The US welcomed discussions with EAC members to find a solution that could fulfil legitimate objectives without unnecessarily restricting trade.

3.5.  The representative of Kenya noted that EAC harmonized alcoholic beverage standards had first been notified by Kenya to the Committee in July 2016. As a result of comments from Members as well as from other stakeholders, the EAC harmonized alcoholic beverage standards had been undergoing review. Kenya appreciated the comments received from the EU and US following Kenya's recent notifications of the revised draft EAC alcoholic beverage standards. These

35 For previous statements follow the thread under IMS ID 510 and IMS ID 519 (under dates raised and references).

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comments were currently under consideration by the EAC regional technical committee, along with the comments received during our public review process. The technical committee was also examining specific issues where clarification may be required, and Kenya would revert with appropriate responses. He explained that the final version of the EAC alcoholic beverage standards by the regional technical committee would have to be adopted by the EAC council of ministers before implementation by individual EAC member states. Kenya remained available for further discussion with the EU and US, and any other interested Members, as the EAC moved towards the final stages of the conclusion and the adoption of the revised EAC alcoholic beverage standards.

3.2.4.31  European Union — Quality Schemes for Agricultural Products and Foodstuffs, G/TBT/N/EU/139, G/TBT/N/EU/139/Add.1 (IMS ID 51236)

3.1.  The representative of the United States recalled that the EU had notified the above-mentioned measure under the TBT Agreement. This was a labelling issue with elements that concerned Codex standards that were subject to TBT disciplines. The United States asked the EU for a status update on Denmark's applications, which had been pending since 2014. Was there a statute of limitations for how long an application could be outstanding? Did an open application ever expire, and if so, would Denmark need to reapply or resubmit its application? Outstanding concerns needed to be discussed amongst both IP and TBT experts as soon as possible.

3.2.  The representative of Uruguay remained interested in the matter, particularly regarding the application of Denmark for the Danbo term as a geographical indication in accordance with EU law. Like the US, Uruguay considered that this theme was relevant to the TBT Committee; it was not only an IP issue. This was certainly so for Danbo: Codex 24/2006, which had been updated many times, established quality criteria for this type of cheese.

3.3.  The representative of the European Union repeated responses given in previous TBT Committee meetings.

3.2.4.32  The Separate Customs Territory of Taiwan, Pehghu, Kinmen and Matsu – Draft of the Organic Agriculture Act, G/TBT/N/TPKM/225, G/TBT/N/TPKM/225 Add.1-2 (IMS ID 51137)

3.1.  The European Union thanked Chinese Taipei for bilateral engagement, and repeated concerns expressed in the previous meeting.

3.2.  The representative of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu reported that the Draft Organic Agriculture Act was still under review and would undergo the legislative process for approval after the final review. He assured the EU that its comment on the one-year period for concluding an equivalence agreement for organic agriculture products would be taken into account along with comments from other WTO Members and domestic stakeholders. Chinese Taipei welcomed consultations on new bilateral equivalence agreements even before the measure was adopted, and would spare no efforts to work with Members on facilitating conclusion of such agreements.

3.3.  Regarding the EU's question about clarity of product coverage and process stage coverage, he said that Article 3 provided their definitions. He stressed that the Organic Agriculture Act was the primary law, and once the Act was adopted, the implementing regulations, which would be based on the current practices, would be announced for commenting. Finally, he mentioned bilateral discussions with the EU over the past months, and at the most recent bilateral meeting in June, the Agriculture and Food Agency had provided more detailed information. Chinese Taipei remained available for further discussion with the EU.

3.2.4.33  China — National Standards on Limits of Volatile Organic Compounds for Furniture, G/TBT/N/CHN/1094, G/TBT/N/CHN/1095, G/TBT/N/CHN/1096 (IMS ID 50938)

3.1.  The representative of the European Union repeated concerns expressed in the previous meeting, as they had not been resolved despite bilateral discussions. China imposed mandatory standards which included unnecessary deviations from well-known international ISO standards. These specific and costly tests raised a question as to whether Chinese testing laboratories would

36 For previous statements follow the thread under IMS ID 512 (under dates raised and references).37 For previous statements follow the thread under IMS ID 511 (under dates raised and references).38 For previous statements follow the thread under IMS ID 509 (under dates raised and references).

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be equipped for carrying out such tests. Furthermore, the parameter TVOC (Total Volatile Organic Compounds) measured a sum of harmful and harmless substances; there was concern that this risked mixing up the tested values for individual substances, meaning that a significant value for a harmful substance could be shrouded by average values. This could have important environmental and/or health consequences. The EU also asked how the differentiation between voluntary and mandatory requirements would apply, e.g. what limits and/or other requirements were included in the notified drafts (e.g. formaldehyde emissions). The EU noted that, as at previous Committee meetings, China had indicated that deviations from international standards were justified by realistic conditions of use – and, she understood, the notified standards were still under development. However, since a considerable time had now elapsed since they had first been announced (July 2015), China was asked to provide a progress report on their development as soon as possible, together with the likely date of entry into force. In the meantime, China was asked to accept equivalent international standards for the relevant product categories.

3.2.  The representative of China reiterated responses given in previous TBT Committee meetings.

3.2.4.34  Kazakhstan, Russian Federation, Kyrgyz Republic — 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, G/TBT/N/KGZ/48 IMS ID 51439

3.1.  The representative of the European Union reiterated his delegation's concerns about the proposed amendment to the Eurasian Economic Union (EAEU)'s Technical Regulation on the Safety of Toys. The EU acknowledged the need to protect children's health and safety but noted that the proposed requirements bore no relation to the stated objective of "protecting children from the possible negative impact of toys on their development and health, causing aggressive behaviour, fear and anxiety". According to the revised proposal submitted by Kazakhstan to the EAEU Working Group in charge of this matter on 31 March 2017, the amendment would now be specifically applied to dolls. The proposal would prohibit the marketing of dolls not complying with the very prescriptive psychological and pedagogical criteria laid down in the proposal. One of these criteria, for instance, related to the requirement that "Dolls must give a true image of a person, corresponding to different age stages; and dolls should be externally attractive and represent the image of a physically healthy person". The EU requested an update on the state of play with respect to process both at EAEU and national level in Kazakhstan and Russia. Following the public consultation conducted by the EAEU last year (until 30 November 2016) on the first draft proposal, the EU had understood that an additional stakeholder consultation had been carried out by the Russian Ministry of Economic Development and Trade (deadline: 14 March 2017), which had resulted in the issuance of a negative opinion on the Kazakh proposal by the Ministry on 28 April. The EU considered this negative opinion as confirming the lack of any scientific basis of the proposed amendment.

3.2.  The representative of the United States said that, while her delegation strongly supported the desire of the Eurasian Economic Commission (EEC) to protect the emotional well-being of children, it was also important to continue discussing with EEC members ways to achieve this objective in a manner that would not unnecessarily restrict trade. The US had a number of concerns with the proposed measures, which would isolate EAEU Members as the only countries in the world to apply such criteria to toys: (i) the fact that the proposed measure could impact trade, by prohibiting access for certain types of dolls, and creating significant uncertainty for exporters; (ii) the lack of specifics regarding pre-market evaluation and potential arbitrary application of the psychological criteria, which were subjective; (iii) the fact that the measures were not based on international standards, which recommended less trade-restrictive alternatives; and (iv) concerns with respect to the proportionality of the measures and the use of risk assessment. In this latter respect, she said that it was unclear to the US how EAEU members had identified and studied the causal risk of particular types of dolls for the emotional well-being of children. The US expected EAEU members to have a scientific basis for the proposed market prohibition that would justify that approach over less trade-restrictive alternatives. The US was unaware of scientific evidence to support the claim that toys negatively impacted a child's well-being. It was impossible to isolate the influence of toys from other influences in a child's life, including the environment in which the child grew up, parenting, and peer influence. Could Kazakhstan please explain the scientific basis for the criteria that were being used to limit toy dolls in its market? The US also suggested that Kazakhstan explore less trade-restrictive alternatives to achieve its objective. For example, age grading was a globally recognized practice cited in international standards that applied to ensure children had access to toys that were appropriate and safe for particular stages of physical and mental

39 For previous statements follow the thread under IMS ID 514 (under dates raised and references).

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development. As noted in Annex 1 to the ISO 8124 Toy Safety Standard, "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 thus urged Kazakhstan to consider the unintended consequences of implementing the measure, as amended, noting that toys that represented children with disabilities would be banned from the market.

3.3.   The representative of Ukraine supported the concerns raised by EU and US. Ukraine requested Kazakhstan and Russia to address the following issues: (i) why certification by conformity assessment body of the EAEU was issuing a certificate of conformity for the toys; (ii)  the existence of requirements for conformity assessment procedures stricter than on the territories of other WTO Members, which were specified in the mentioned Technical Regulations, should be justified on the basis of provision of a scientifically substantiated clarification by Kazakhstan and the Russian Federation; (iii) the fact that the requirements that conformity assessment procedures did not create unjustified barriers to international trade (TBT Article 5.1.2) had not been met. Ukraine called on Kazakhstan and Russia to remove unjustified technical barriers to trade and to bring the provisions of the mentioned technical regulations in line with international practice, and to respond all comments and concerns Ukraine had sent to Kazakhstan previously in March.

3.4.  The representative of Kazakhstan said that, with respect to the questions of the US and EU regarding the scientific basis, the draft amendments had been initiated on the basis of the scientific research called "Impact of Toys Which Do Not Meet Psychological and Pedagogical Criteria to Psychological Health of Children", conducted by Kazakh State Woman Pedagogical University in 2016. The draft amendments were still being discussed by the working group in order to take into account comments received during public consultation. The representative thanked the US for constructive conversation at the DVC held between their capitals shortly before the meeting. The comments and proposals had been very useful and served as a good basis for further improvement of the draft amendments. Kazakhstan would study carefully the ISO standards referred to by EU and the US and explore if they were helpful to achieve Kazakhstan's legitimate objective. He also expressed Kazakhstan's strong commitment to WTO rules and its intention to making every effort to reach a less trade-restrictive effect of the measure. With respect to the comment of Ukraine, he referred to Kazakhstan's previous answers, made in November 2016 and March 2017.

3.5.   Public consultations on the draft technical regulation had taken place in July-August 2010. No comments or questions had been received from Ukraine in the course of these consultations. Certification of conformity of toys had always been applied in Kazakhstan, even before adoption of the Customs Union Technical Regulation "On Safety of Toys". Kazakhstan's authorities had never registered any problem with obtaining conformity certificate for products originating from Ukraine. To date, 83 certificates had been issued by Kazakhstan's conformity assessment bodies to the toys of Ukraine. He further noted that several other WTO Members also required certification of conformity. He concluded by reminding Ukraine that the TBT Agreement did not preclude a Member from choosing a type of conformity assessment scheme that it considered appropriate in ensuring its legitimate objective.

3.6.   The representative of the Russian Federation said that in the EAEU, each member could initiate the development of technical regulation or amendments to technical regulation. Russia was not the developer of draft amendments No. 2 to the Technical Regulation of the Customs Union on Safety of Toys. Like other WTO Members, the Russian Federation and Russian stakeholders had participated in the public discussion. According to the procedure on drafting, adopting, amendment and cancellation of the EAEU technical regulations (adopted by Eurasian Economic Commission Council Decision No. 48 of 20 June 2012) a special Working Group had been created including representatives of all member states to review the draft amendments, as well as all comments received.

3.2.4.35  Korea — Amendment of the Notifications on Warning Messages on Smoking and Drinking G/TBT/N/KOR/664, G/TBT/N/KOR/664/Add.1 (IMS ID 51840)

3.1.  The representative of the European Union repeated the concerns raised in the previous minutes. Regarding the transition period for application for the measure, he understood that Korea had shown flexibility in accommodating the concerns of Members relative to the need to provide sufficient time for industry to adapt to the new measures, and that the end of the transition period

40 For previous statements follow the thread under IMS ID 518 (under dates raised and references).

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had been set at 8 February 2018. He asked Korea to confirm that 8 February 2018 was the final date for placing the imported goods on the Korean market, which could then be sold until exhaustion of stocks, or else to clarify the exact sequence of events for implementation of the measure.

3.2.  The representative of Japan repeated its support for Korea's measures aimed at reducing harmful use of alcohol. His delegation had requested Korea to extend the transition period via comments on the notification and at past meetings. Japan had also sent a joint letter from the Embassy of Japan in Korea along with embassies of six Members concerning this issue and had received a reply from the Ministry of Health and Welfare the previous month. The reply indicated that the Ministry had accepted, in part, its request for an extended transition period and allowed liquor importers to sell liquor with the previous warning labels until 8 February 2018. His delegation appreciated that Korea had partially taken into account its comment, and sought confirmation that wholesaler or retailers' stocks with old warning labels could be sold by 8 February 2018, and that importers would not have to recall them to enforce the new requirement. If Korea were not to introduce the measure, Japan requested Korea to allow exhaustion of stocks without enforcing the new requirement, due to the difficulty for liquor importers to recall liquors once they were sold. Lastly, Japan requested Korea to announce this modification of transition period adequately to liquor industries and relevant stakeholders in order to avoid confusion, and to enforce it appropriately.

3.3.  The representative of the United States repeated its concerns with the measure in question. While supporting Korea's efforts to inform consumers about the risks of excessive alcohol consumption, her delegation remained concerned about how these requirements would impact its industry. She welcomed Korea's response to its comments, including to a joint letter sent by a number of embassies in Seoul. In that letter Korea indicated that an extended adaptation period would be provided to enable alcoholic beverages to be sold with previous warning labels until 8 February 2018. While grateful that Korea had considered its request for an extended transition period, her delegation remained unclear about the scope of this adaptation period. She asked for clarification if the measure in its entirety would not be enforced until 8 February 2018, or whether it only applied to some warnings and some products. The representative emphasized that it was particularly important to receive clear advice about dates for compliance, given the number of changes that Korea had made to this measure since it was notified.

3.4.  The representative of Australia had joined other Members in writing to Korea's Ministry of Health and Welfare on 28 March 2017 to express concerns regarding the new alcohol warning label requirements. He repeated the concerns raised in the previous minutes, continuing to request an official English translation of the proposed health warning statements, to question the direct link between alcohol consumption and certain diseases, and to request a scientific basis for the measure in question. He noted the disparity between the period for presentation of comments by Members (27 September 2016), and the date that the new requirements came into effect (3 September 2016). In addition, amendments to the text of one of the proposed warning label options (8 December 2016) now had a separate implementation date (8 February 2018) to the other two labels (1 September 2017). His delegation requested an appropriate comment period to allow time for comments from Members to be taken into account.

3.5.  The representative of Canada thanked Korea for its recent letter in response to concerns raised by Canada and other Members regarding its alcohol labelling measure. His delegation also welcomed the positive news regarding Korea's decision to delay compliance with the new warning labels until 8 February 2018. However, Canada requested the full detail of the regulation, including the proposed language of the warning labels in English to be able to fully assess the potential impact of the measure.

3.6.  The representative of Chile associated his delegation with the concerns already raised, and requested greater information and clarification about the implementation of this measure.

3.7.  The representative of New Zealand acknowledged and supported Korea's right to introduce new regulations to address specific public health concerns. New Zealand appreciated that, in seeking to address the harmful use of alcohol, this measure was directed towards achieving a legitimate public health objective. She thanked Korea for its engagement regarding the Notifications on Warning Messages on Excessive Drinking, and noted that Korea had taken into account some of the comments made by Members by extending the adaption period until 8 February 2018. Her delegation would appreciate additional details with regards to the implementation of the extended adaptation period. The Ministry of Health and Welfare of Korea

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had confirmed that the previous alcohol warning labels could be used until 30 August 2017, with the new labels to be used from 8 February 2018. She enquired how the measure would be enforced between 30 August 2017 and 8 February 2018. Would any product complying with the previous requirements not be able to be imported from 30 August 2017? Would such products imported by 30 August 2017 be able to remain for sale in shops until 8 February 2018? Further, if such products remained unsold by 8 February, would they be able to be sold after this date until exhaustion of stocks? Her delegation then repeated its request for an official English translation of the new warning messages, in order to avoid any confusion among producers.

3.8.  The representative of Mexico associated her delegation with the concerns raised, and thanked Korea for its feedback. Her delegation reiterated its recommendation that the warnings be translated into English to avoid confusion.

3.9.  The representative of the Republic of Korea replied that a six-month adaptation period would be provided for alcoholic beverages which were imported before 9 August 2017 to ensure smooth implementation of this measure. Thus, those beverages could be sold with existing labels until 8 February 2018. His delegation reiterated that the companies could choose one of the three labels as stated on the regulation, giving companies the flexibility to select the most appropriate expression from their own perspective. Korea remained available for further discussion with interested Members and stakeholders to resolve all concerns in a transparent manner.

3.2.4.36  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 52141)

3.1.  The representative of the European Union repeated concerns raised and questions posed by his delegation in the last meeting.

3.2.  The representative of the United States repeated the concerns raised in the previous meeting. The US also understood that the Russian Government had conducted 195 inspections of foreign plants which resulted in 61 denials compared to 165 inspections of Russian plants which resulted in zero denials. Could Russia explain whether the review was different for foreign plants or why this discrepancy existed? Russia had stated at the March 2017 Committee meeting that the previously issued registration certificates would be valid for a certain transitional period. For how long would that period be? Would it be possible to provide a transition time so that Russian citizens would not lose access to innovative lifesaving medicines and so that the Russian livestock and pets would not be at increased risk to infectious diseases? The US also asked Russia to confirm whether it would require that clinical trials for orphan drugs be conducted in Russia. It appeared, in this respect, that the Russian Ministry of Industry and Trade/GMP Institution planned to visit the US in July 2017 to conduct GMP training. The US was open to having technical discussion with Russia regarding GMP best practices.

3.3.  The representative of Ukraine echoed the concerns raised by other delegations and would continue to follow this issue.

3.4.  The representative of the Russian Federation explained that the "Agreement on Common Principles and Rules of Pharmaceutical products Circulation in the Eurasian Economic Union" had been signed in December 2014. He also informed that all documents of the EAEU on turnover of pharmaceutical products had entered into force on 6 May 2017. However, the entry into force of these documents did not mean a sharp change in the existing system of registration. As of now, producers and importers would have the opportunity to register pharmaceutical products in the Russian system or in the system of the Eurasian Economic Union. Registration certificates issued in the Russian registration system would be valid only in the territory of the Russian Federation. Registration certificates issued in accordance with the rules of the Union would operate on the territory of all countries of the Union. This transition period would last until 31 December 2021. In 2022 the Russian registration system would be completely replaced by the system of the Union. Moreover, previously issued registration certificates would be valid until 31 December 2025. As for the system of GMP, he noted that Russia had already tried to answer all the questions of WTO Members in detail at the previous meeting of the TBT Committee.

41 For previous statements follow the thread under IMS ID 521 (under dates raised and references).

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3.2.4.37  Ireland — Public Health (Alcohol) Bill 2015, G/TBT/N/IRL/2 (IMS ID 51642)

3.1.  The representative of Mexico repeated concerns raised at previous TBT Committee meetings on the labelling requirements contained in the measure. She asked what was the technical and scientific evidence used when assessing the risk of non- fulfilment and requested information on the approval status before the EU.

3.2.  The representative of the European Union reiterated the replies provided in previous meetings of the Committee.

3.2.4.38  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 52043)

3.1.  The representative of the United States repeated concerns raised in previous TBT Committee meetings and again requested Russia to share the status of implementation of the new regulation and the number of new and re-registrations that had been filed but not yet processed; respond to the enquiry expressed by the US industry via the Enquiry Point; and consider a meeting with industry to discuss their concerns with the implementation of Russia's new medical device registration, as well as the EEU draft agreement and guidance.

3.2.  The representative of the European Union repeated concerns raised in previous TBT Committee meetings and repeated their requests regarding the short comment periods provided; the long review time for dossiers (G/TBT/N/RUS/51); the transition periods for entry into force and the recognition of international standards/best practices (G/TBT/N/RUS/52); the information to be included in the "labelling" (G/TBT/N/RUS/53); and the "recognition by expert reports" (G/TBT/N/RUS/55).

3.3.  The representative of Ukraine supported the concerns raised by the EU and US and drew attention to some inconsistencies in the mentioned documents with the requirements of the TBT Agreement. The package of documents referred to by Russia during the March 2017 Committee meeting, which had been developed according to the draft agreement, were not in compliance with requirements under the TBT Agreement. The requirements of the draft agreement needed to be justified on the basis of scientifically substantiated clarification concerning application of the stricter 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 was conducted by expert authorities defined by the member states of the Eurasian Economic Union (EAEU). The mandatory requirement for applicants to register on the territory of member states of the EAEU put national producers and producers from other member states of the WTO in an unequal position. The reference of the representative of the Russian Federation to the existence of the transition period of the draft agreement before entering into force was not the condition for the removal of already existing technical barriers to trade. Conformity assessment procedures provided for medical devices differed significantly from international practice, which provided for the manufacturer to declare conformity of its products to requirements of technical regulations. The draft agreements specified requirements for implementation, installation, repair and disposal of medical products that were inconsistent with international practices. Ukraine requested that Russia further clarify the information to be included in the labelling and in the operational documents. Ukraine called on Russia to remove unjustified technical barriers to trade and bring the provisions of the draft documents on medical devices in line with international practice.

3.4.  The representative of the Russian Federation said that the Agreement on Common Principles and Rules of Medical Devices Circulation in the Eurasian Economic Union had been signed in December 2014 and that all documents of the EAEU on turnover of medical devices had entered into force on 6 May 2017. However, the entry into force of these documents did not mean a sharp change in the existing system of registration. Producers and importers had the opportunity to register medical devices in the Russian system or in the system of the Eurasian Economic Union. Registration certificates issued in the Russian registration system would be valid only in the territory of the Russian Federation while registration certificates issued in accordance with the rules of the Union would operate on the territory of all countries of the Union. The transition period would last until 31 December 2021. In 2022 the Russian registration system would be completely replaced by the system of the Union. Moreover, previously issued registration certificates would be

42 For previous statements follow the thread under IMS ID 516 (under dates raised and references).43 For previous statements follow the thread under IMS ID 520 (under dates raised and references).

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valid until 31 December 2025. Russia took note of concerns raised by the interested Members and was ready to continue working with them on this matter.

3.2.4.39  China — Cybersecurity Law (IMS ID 52644)

3.1.  The representative of the United States repeated the concerns raised in the previous minutes, and noted that in the TBT Committee meeting, her delegation had already discussed its specific concerns with China's proposed cybersecurity review regime, as well as cybersecurity rules for the civil aviation, banking, insurance, and Internet of Vehicles sectors. More specifically, the US was concerned about China's Cybersecurity Law, which was implemented on 1 June despite serious and long-standing concerns from the US and many other international stakeholders. It was understood that related implementing measures, introducing cybersecurity regulations into additional critical sectors of the Chinese economy, would be developed over the coming months.

3.2.  She noted that TC 260 had made some changes to the standards based on the feedback it had received, and expected China to notify the TBT Committee should TC 260 or other voluntary standards be incorporated into a technical regulation or conformity assessment procedure, given China's WTO transparency obligations and bilateral commitment at the 2016 JCCT to notify relevant "secure and controllable" technical regulations. Her delegation requested that China afford subsequent opportunities for interested parties to submit comments on revised iterations of these draft standards, and all other implementing measures related to the Cybersecurity Law. Given the broad potential impact of these standards and measures and the serious concerns they had raised, it was critical that China act deliberately to collaborate with all interested parties, and take their comments into account before adopting the drafts as written. The US would continue to carefully monitor China's implementation of the Cybersecurity Law and related measures, and to continue the important dialogue.

3.3.  The representative of the European Union noted with concern the entry into force on 1 June 2017 of the new Cybersecurity Law. The EU had provided written comments in 2016 detailing these concerns on: (i) the scope of the requirements was not clear as key terms had not been specified in sufficient detail. Concepts such as "critical information infrastructure" and "secure and trustworthy products" were not clarified, which led to a lack of clarity as to which sectors were impacted by the measures; (ii) recalling the importance of international standards, his delegation noted that the law only referenced national standards which could lead to lack of interoperability with international standards. In the development of national standards, it would be appropriate to build on existing international standards and to involve all relevant stakeholders, including foreign invested and wholly-foreign owned enterprises, in a non-discriminatory manner in the relevant technical committees; (iii) regarding the certification and security requirements on critical information infrastructure, the EU was concerned that such requirements led to a de facto ban on products and services from foreign-invested enterprises providing products and services to businesses falling under the notion of "critical information infrastructure." The EU called on China to implement these provisions in a non-discriminatory manner, and to respect the principles of proportionality, necessity and technology neutrality. Moreover, he repeated its previous requests for clarifications on the relationship to existing multi-level-protection systems (MLPs) and the expected timeline of implementation; (iv) as regards data localization, the EU understood that the storage obligation had been replaced by controls on cross-border transfers of data. The EU was concerned that these controls created the same level of restriction as the obligation to store data in China. Moreover, the EU noted with concern that the scope of the relevant obligations had been enlarged to "network operators" in general, rather than only those of critical information infrastructure. The EU appreciated that the date of entry into force of these specific measures had been postponed to 31 December. Furthermore, the EU welcomed the opening for public comments of TC260 standard which defined the concept of "important data".

3.4.  The EU noted with concern that the Cybersecurity Law had already been applied and was enforceable with possible fines and sanctions, while the implementing measures that would clarify its implementation were still not in place. The current situation created a lot of uncertainty for economic operators. The EU requested China to notify draft measures in any subsequent sectoral implementation to the TBT Committee in order to give adequate opportunity for WTO Members and their stakeholders to comment on any subsequent developments.

3.5.  The representative of Japan expressed concern and strong interest with regard to the Cybersecurity Law, which had entered into force on 1 June 2017, on which it had submitted

44 For previous statements follow the thread under IMS ID 526 (under dates raised and references).

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opinions during the public comments periods of the first draft in July 2015 and of the second draft in July 2016. Regarding the law, after its adoption in November 2016, industrial circles had expressed significant concern, for example via the global association letter issued in May 2017 by 54 organizations from 11 countries all over the world. Japan still had particular concerns about the law and its relevant regulations, because definitions, requirements and scope of standards or procedures for conformity assessment adopted in them were not clear. Recalling China's clarified definition on "secure and controllable" and its explanation that such a term did not mean the requirement of using Chinese technology or the procurement of domestic products, his delegation requested China to make the related regulations reflect such an explanation and be consistent with international standards and practices. In case the standards to be adopted were not consistent with international standards, Japan asked China to comply with the TBT agreement through appropriate procedures based on the Article 2 and Article 5 for conformity assessment procedures.

3.6.  The representative of Canada supported the comments of the other WTO Members regarding China's Cybersecurity Law and would follow it closely, consistent with Canada's intervention in the previously raised STC No. 4. 45

3.7.  The representative of Australia echoed the concerns of the US, EU, Japan, and Canada, and repeated the concerns raised in the previous meeting. She suggested that the implementation period be delayed until there was greater certainty around the scope and application of its provisions. Her delegation encouraged China to provide further information about the measure so that the requirements could be considered, including the definition key terms, publication of implementing regulations, inspection and certification requirements, and the scope of the sectors covered. Australia welcomed the opportunity for further consultation with Members to ensure the measures were implemented in a way that was no more trade restrictive than necessary.

3.8.  The representative of China recalled President Xi's remarks on opening-up as a basic policy of China, which was also the principle of China's cyber security policy. Based on opening-up and globalization, the law aimed at ensuring cyber security and national security in China, and would not be an excuse to close the door to the outside world. She outlined the definition of secure and controllable. 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. 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 noted that data storage and other similar matters were beyond the scope of the TBT Agreement, and therefore it was not appropriate to discuss them in the Committee.

3.2.4.40  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 52746)

3.1.  The representative of the European Union reiterated concerns raised in the previous meeting. In addition she asked for further information on whether any European car maker had been placed on the MIIT NEV subsidies list of those that would benefit from NEV incentive measures in China. The EU also welcomed confirmation from China that, as regards the requirement of sufficient capacity concerning R&D laid down in Article 7 Point III of the notified draft contained in G/TBT/N/CHN/1187, there is no obligation for the car manufacturers to have their R&D facilities located in China in order to be given market access.

3.2.  The representative of Japan reiterated concerns raised in the previous meeting. Regarding G/TBT/N/CHN/1187, given the significant impact the Tentative Administrative Rules would have on the automobile industry he asked if these rules had been modified since notification in December 2016. Japan was particularly interested in the coefficient credit values for NEVs as they had a major impact on production plans and requested that China provide the opportunity for dialogue with automobile manufacturers and other relevant entities as soon as possible. Japan encouraged China to consider the concerns raised before the official announcement and enforcement of the Tentative

45 Para. 3.7146 For previous statements follow the thread under IMS ID 527 (under dates raised and references).

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Administrative Rules. Regarding G/TBT/CHN/N/1188, Japan requested to reconsider the following three points such as systems of the national and local monitoring platforms, period for monitoring and recording, and lack of sufficient lead time. Japan proposed that China consider its requests in the development procedure of the guideline for the regulation, and not to impose unnecessary obstacles to international trade.

3.3.  The representative of China reiterated that China was facing energy and environmental challenges. The development of new energy vehicles was crucial for saving energy and environmental protection and international practice was to strengthen the administration of vehicles. The 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 regulated vehicles produced and sold in China. As the number of new energy vehicles was increasing dramatically, China had to respond to the urgent need to protect human life and public security because of the higher risk brought by the new technology. China had therefore revised the 2009 administration regulation on the access of new energy vehicle manufacturers and products. In order to ensure safety and quality, the new energy vehicle manufacturers were required to obtain design capability. It did not require companies to establish R&D centres in China, or to localize the control and power system, and was non-discriminatory and in line with the TBT Agreement.

3.2.4.41  Italy — Labelling requirements of the origin of grains used in the preparation of dried pasta (IMS ID 53047)

3.1.  The representative of Mexico reiterated the systemic concern regarding Italy’s proposed decree that would require the labelling of dry pasta products to include the name of the country or area of origin of the grain used to manufacture the product, or the name of the place where the product was manufactured. She again requested that consideration be given to the Panel and Appellate Body reports ruling against the US measure. She recalled transparency obligations under the TBT agreement and requested the EU to notify the measure to TBT Committee Members. Finally, she requested information regarding the status of the decree.

3.2.  The representative of Canada repeated concerns raised at the previous TBT Committee meeting. Mandatory COOL measures could cause discrimination within food supply chains, where locally sourced ingredients could become the de facto choice for producers to the detriment of imported like ingredients. There could also be negative effects for millers and pasta producers in Italy who relied on imports of durum wheat to meet their production demand.

3.3.  The representative of Brazil supported the concerns raised by other delegations. Brazil believed that these Country of Origin measures in the EU were setting dangerous precedents and requested that the EU consider alternative approaches. Like other delegations, Brazil encouraged the EU and its member States to notify such measures, so as to give Members the opportunity to provide comments.

3.4.  The representative of the European Union repeated the explanations on the EU relevant legal framework made at the previous TBT Committee meeting. In addition, she clarified that Italy had notified a draft decree on the origin indication of durum wheat for pasta to the Commission on 12 May 2017 which was currently under assessment by the Commission.

3.2.4.42  European Union — Organic production and labelling - Maté (erva-mate) (IMS ID 52448)

3.1.  The representative of Brazil thanked the EU for the very productive bilateral meeting held the previous day. The EU had presented answers to many questions and both delegations had engaged in a fruitful discussion. Nevertheless, Brazil was of the view that it was important to keep the erva mate subject as a specific trade concern in the Committee to stress the importance of the issue and to reaffirm Brazil's interest in the approval of the new European legislation EC 180/2014, with the inclusion of erva mate in the list of organic products. Brazil was hopeful that once the "trialogue" among the Commission, Parliament and the Council about the new legislation on labelling of organic products was resumed, the European authorities would recognize the evolution since the establishment of the previous list of organic goods and insert erva mate in the new list.

47 For previous statements follow the thread under IMS ID 530 (under dates raised and references).48 For previous statements follow the thread under IMS ID 524 (under dates raised and references).

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3.2.  The representative of the European Union said that, as already explained at the March 2017 TBT Committee meeting and during their bilateral meeting, maté was excluded from the scope of the EU organic legislation (Regulation (EC) No 834/2007 on organic production and labelling of organic products), since it had not been included in Annex 1 of the Treaty on the Functioning of the European Union. Therefore, this product could not be certified as organic under the EU legislation and bear the EU organic logo. Within the framework of the current review of the EU organic legislation, the European Commission had proposed to include maté within the scope of the future EU legislation on organics. However, it was difficult to predict the final outcome of the Commission proposal. Inter-institutional discussions (trilogues) on the new EU organic regulation were on-going with EU co-legislators (the European Parliament and the Council) and the final result would not depend only on the Commission. The objective was to reach a possible political agreement by the end of the year. Once the final wording on the Commission proposal was agreed, the EU would be pleased to inform the Brazilian delegation accordingly.

3.2.4.43  European Union — Radio Equipment Directive, G/TBT/N/EU/93 (IMS ID 52549)

3.1.  The representative of China again raised concerns on Directive 2014/53/EU, also called RED, which replaced the 1999/5/EC, R&TTE, and which covered a wide range of products. While the deadline of the transition period (12 June 2016 to 12 June 2017) had passed, there was still unclarified ambiguity in the Directive. Enterprises did not know what to follow because of the lack of guidelines and this affected their production and research and development. China kindly requested the EU to release the RED guidelines and coordination standards. She recalled that the EU considered the coordination standards non-mandatory. However, the Directive required the equipment to be in conformity with the official coordination standards, so as to meet the basic requirement in Article 3 of the directive, which China believed made the coordination standards mandatory. China was concerned about the resulting uncertainty which constituted a significant risk for exporting enterprises, due to the renewal of the previous standards and the lack of release of coordination standards. Finally, she noted that if the EU could not provide a timetable for the release of official guidelines and coordination standards, China would appreciate an extension of the transition period.

3.2.  The representative of the United States expressed concern that US companies were facing difficulties demonstrating compliance with the EU's RED. She considered the European standardization system to be closed to US stakeholders' participation and, consequently, to create uncertainty for US companies. US companies could not benefit from the presumption of conformity by demonstrating compliance with the harmonized European Telecommunications Standards Institute's standards because a number of them were not available when the directive had become effective. The US had requested information on the implementing timeline, a two-year transitional period and an update on the status of not yet adopted standards. Her delegation understood that interim solutions until harmonized standards were finalized included republishing standards of the previous Directive (Radio and Telecommunications Terminal Equipment Directive). She asked whether the Commission envisioned a transitional period when final standards were published.

3.3.  The representative of the European Union repeated its statement in the previous meeting. In addition, he mentioned that the transitional period issue was being resolved and did not create barriers to trade. The RED could apply without the publication of harmonized standards, was technology neutral and allowed for the use of manufacturers' technical solutions that complied with its essential requirements. He said that the extra cost of notified bodies' intervention equally affected manufacturers and was set out in the laws of other Members. 90% of the delivered harmonized standards (114 of 126) were "unique" and published in the Official Journal of the European Union in 8 June. 20 additional harmonized standards of the previous directive would be published to cover the transmitter part of the equipment. Notified Bodies' guidance for this equipment accepted the transmitter part to be covered in the Radio and Telecommunication and Terminal Equipment Directive and required assessment only to the receiver part. He noted that a number of RED harmonized standards were still missing as the list in June would have 134 "unique" harmonized standards. The EU believed that there was no impediment in applying legal and viable solutions for the placement of radio equipment on the EU market as the Commission survey on Notified Bodies' capabilities concluded that 40% of them worked under low and 20% under normal load.

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

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3.2.4.44  Korea — Household Chemical and Biocidal Products, G/TBT/N/KOR/684, G/TBT/N/KOR/547, G/TBT/N/KOR/702 (IMS ID 52950)

3.1.  The representative of the United States reiterated concerns with the Control Scheme to restrict the use of hazardous materials in electronic and electrical devices. She asked for clarification on how many products had been banned as G/TBT/N/KOR/684 stated that the ban covered 15 products whereas Korea had said in the previous meeting that the ban extended to 18 products.

3.2.  The representative of the Republic of Korea confirmed that 18 types of products had been included in the "Designation of products of risk concerns, and safety and labelling standards" notified in G/TBT/N/KOR/684. Korea designated CMIT and MIT as ingredients as they could be used in various mixtures. Korea had banned the use of spray type and all types of air freshener with CMIT/MIT in order to prevent respiratory exposure of CMIT/MIT as these substances had caused a terrible accident in Korea where 117 people had died and 4,602 people affected.

3.2.4.45  United Arab Emirates – Control Scheme to restrict the use of hazardous materials in electronic and electrical devices, G/TBT/N/ARE/265 (IMS ID 49651)

3.1.  The representative of the European Union repeated concerns with the control scheme to restrict the use of hazardous materials in electronic and electrical devices.

3.2.  The Chairman took note of the EU's statement and requested that the Secretariat convey the EU concerns to the delegation of the UAE.

3.3  Exchange of Experiences

3.3.1  Thematic Session on Risk Assessment

3.1.  The Moderator's report on the thematic session is contained in G/TBT/GEN/226.

3.4  Eighth Triennial Review

3.1.  The Chairman recalled that at the informal meeting – chaired by the outgoing Chairperson earlier in the week, Ms Esther Peh (Singapore) – delegations had discussed the timeline and approach to the upcoming Eighth Triennial Review. He said that the approach was straightforward: the review process would be driven by substantive proposals from Members relating to specific areas of the Committee's work (e.g., conformity assessment procedures, transparency, standards – or good regulatory practice). The proposals could also relate to the operation of the Committee, for example on specific trade concerns, or on thematic sessions. It was noted that, normally, discussions built on work already undertaken by the Committee, documented in G/TBT/1/Rev.13 (compilation of all the Committee's decisions and recommendations to date). The timeline, he said, was clear: the Committee had one year to complete this process, starting in November 2017. This meant that at each of the Committee's meetings until November 2018 the Eighth Triennial Review would be on the agenda.

3.2.  The Chairman said that a draft timeline had been considered at the informal meeting (distributed as a room document with the title "Advance copy" and dated 13 June). In light of comments made, the wording had been slightly revised at the end of the first paragraph on the document. The last two sentences were intended to clarify two things. First, submissions were welcome ahead of the Committee's November 2017 meeting. Second, submissions would be considered on a rolling basis as they came in. In other words, any submissions made before the November meeting would be discussed at the November meeting, and any submission received ahead of the March meeting would be discussed at the March meeting. Of course, Members could always revert to submissions made at earlier dates at any time before the review's conclusion. The final deadline for making submissions under the triennial review remained 1 June 2018. The Chairman stressed that time was short and encouraged Members to submit any proposals as soon as possible in the process.

50 For previous statements follow the thread under IMS ID 529 (under dates raised and references).51 For previous statements follow the thread under IMS ID 496 (under dates raised and references).

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3.3.  The Committee agreed on the timeline as contained in document G/TBT/W/450. It was also agreed that the day set aside for the thematic session to be held on 7 November 2017 would be dedicated to the Eighth Triennial Review.

4  TECHNICAL ASSISTANCE ACTIVITIES

4.1.  The representative of Canada informed the Committee that the Canadian Enquiry Point had hosted officials from the Trinidad and Tobago Bureau of Standards (TTBS) in Ottawa. The workshop provided an opportunity to learn about the day-to-day activities of Canada's WTO TBT & SPS Enquiry Point and was an opportunity to share knowledge and exchange ideas pertaining to the general operation and oversight of national enquiry points. The programme for the week was divided into several parts, with several workshop sessions interspersed between presentations and meetings with other Government of Canada departments and agencies. The sessions focused on: an overview of the TBT and SPS notification requirements; the process undertaken by Canada's Enquiry Point to identify technical regulations in the Canada Gazette, Canada's regulatory newspaper; best practices for stakeholder engagement, such as government regulators and industry groups; the WTO's electronic resources and databases; and, a hands-on activity to process and submit TBT notifications through the WTO's TBT Notification and Submission System. Canada's procedures for handling comments, extension requests and responding to client enquiries, and an overview and activity on the methods used by the Canadian Enquiry Point to maintain electronic records was also included in the programme.

4.2.  Colleagues from Trinidad and Tobago were also given the opportunity to meet separately with representatives from: the Regulatory Affairs Secretariat in Canada's Treasury Board Secretariat, the Canadian Government ministry responsible for enforcing good regulatory practices amongst Canada's regulators; the Standards Council of Canada; and the Canadian Food Inspection Agency. These meetings provided an opportunity for exchanges on: the role and structure of the Regulatory Affairs Secretariat in the context of Canada's regulation-making process, as well as Canada's regulatory system and regulatory cooperation initiatives such as the Canada-United States Regulatory Cooperation Council; Canada's conformity assessment system as well as an overview of the structure and mandate of the Standards Council of Canada, and the origins of the Canadian Food Inspection Agency, what it does, the complexities of its mandate which covers food safety and animal and plant health, and the key role the Canadian Food Inspection Agency played in Canada's participation in the WTO SPS Agreement. He expressed his delegation's appreciation for the participants' engagement. Canada was not only grateful for the opportunity to share Canada's experiences and approaches to the operation of a TBT and SPS Enquiry Point, but also for the learning opportunity it afforded Canada relating to the challenges faced in Trinidad and Tobago to the optimal functioning of its Enquiry Point.

4.3.  The representative of Trinidad and Tobago thanked Canada and looked forward to further cooperation.

4.4.  The representatives of IEC, BIPM, OIML updated the Committee on their activities related to technical assistance activities.1

4.5.  The Secretariat provided information on TBT related activities in the Global Review of Aid for Trade and made available a document on its technical assistance activities2

5  UPDATING BY OBSERVERS

5.1.  The representatives of WHO, Codex, IEC, BIPM, OIML, UNECE and UNIDO provided updates on their activities related to the TBT Committee.1

5.2.  The representative of Codex said that coherence between Codex and WHO policies was very much a priority for both and as it was something that was coming up in the Committee it was important to highlight. Relating to the concerns on alcohol beverage labelling and to nutrition claims labelling, she said Codex encouraged countries to participate in the food labelling committee which would be meeting in Paraguay in October where front-of-pack labelling would be on the agenda. There would also be a proposal from WHO on the labelling of alcoholic beverages in

1 G/TBT/GEN/230, G/TBT/GEN/231, G/TBT/GEN/232.2 G/TBT/GEN/228 and RD/TBT/225.1 G/TBT/GEN/229, G/TBT/GEN/233, G/TBT/GEN/230, G/TBT/GEN/231, G/TBT/GEN/232, G/TBT/GEN/234,

G/TBT/GEN/235.

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particular to try and align with the WHO strategies. As a general observation, she noted that an absence of a Codex standard or absence of certain issues being addressed in a Codex standard did not preclude a country from developing their own standards and legislation and this did not necessarily mean that they were in contradiction with Codex.

5.3.  The representative of the United States thanked WHO and Codex for bringing the attention of the TBT Committee to the important developments in their work on nutrition. The US valued and appreciated Codex's member-driven process and its adherence to science-based transparent consensus approach to standards development. She stressed that topics mentioned by Codex, for example proposed new work regarding front-of-pack labelling and incorporation of references in Codex standards into World Health Assembly resolution and guidance documents related to marketing restrictions of breast milk substitutes were still under discussion by Codex members. The US understood that these issues were still being discussed in electronic working groups designed to develop work between Codex committee sessions in an effort to build consensus in the committee. Further alcohol labelling had not yet been proposed as a new area of work in Codex technical committees. The US encouraged the TBT Committee to continue active engagement in the work of Codex and WHO as they involved important topics related to public health and trade concerns that were being discussed in the Committee.

6  DATE OF NEXT MEETING6.1.  The next regular meeting of the Committee will be held on 8-9 November 2017, with one day set aside for discussion on the Eighth Triennial Review on 7 November 2017.

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