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G/TBT/M/75

14 September 2018

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Committee on Technical Barriers to Trade

MINUTES OF THE MEETING OF 20-21 JUNE 2018

CHAIRPERSON: MS KATE SWAN (NEW ZEALAND)

Note by the Secretariat1

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

2 ELECTION OF THE CHAIRPERSON ................................................................................ 1

3 STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2................................................... 1

4 SPECIFIC TRADE CONCERNS (STCS) ........................................................................... 2

4.1 Reported resolutions .................................................................................................... 2

4.2 Withdrawn concerns .................................................................................................... 2

4.3 New concerns ............................................................................................................. 2

4.4 Previously raised concerns ............................................................................................ 6

5 EIGHTH TRIENNIAL REVIEW - CHAIR'S REPORT AND NEXT STEPS ........................... 46

6 TECHNICAL ASSISTANCE ........................................................................................... 46

7 OBSERVERS ............................................................................................................... 46

7.1 ISO: ongoing revision of ISO/IEC Guide 59 ....................................................................46

7.2 Updates from Observers ..............................................................................................48

7.3 Pending Requests .......................................................................................................48

8 DATE OF NEXT MEETING............................................................................................ 51

1 ADOPTION OF THE AGENDA

The Committee adopted the agenda contained in WTO/AIR/TBT/11.

2 ELECTION OF THE CHAIRPERSON

The Committee elected Ms Kate Swan (New Zealand) as TBT Committee Chairperson for 2018.

3 STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2

3.1. The Chairperson 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/40), issued on

1 This document has been prepared under the Secretariat's own responsibility and is without prejudice

to the positions of Members or to their rights and obligations under the WTO.

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12 March 2018. Information on the list of statements is available on the TBT Information Management System (TBT IMS).

The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu introduced the revision to their original statement under Article 15.2. She highlighted two areas of importance to Chinese Taipei - transparency and National Quality Infrastructure (NQI). So as to enhance public participation in formulating government policy, an online public participation forum

had been put in place in 2015. NQI supported the implementation of the TBT Agreement. A well-developed NQI gave regulators the confidence to develop regulations that both achieved the legitimate objectives and addressed their implications to trade.

4 SPECIFIC TRADE CONCERNS (STCS)

4.1 Reported resolutions

There were no reported resolutions.

4.2 Withdrawn concerns

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

a. European Union — The harmonized standards and relevant conformity assessment procedure of Regulation (EU) 2016/679 of the European Parliament and of the Council.

4.3 New concerns

4.3.1 Brazil — Draft Technical Resolution n° 51, 7 April 2017 on labelling of beverages,

wine, and grape derivatives, G/TBT/N/BRA/719, G/TBT/N/BRA/719/Add.1

The representative of the European Union noted that Brazil had not yet replied to its comments on notification G/TBT/N/BRA/719, which had been sent on 16 August 2017. She stressed the importance of clear and proportional requirements on labelling for European wine and spirits producers exporting to Brazil and asked for clarification of the relation of the draft to other regulations, including general rules on consumer protection and specific regulations on wine, which seemed to partly overlap; in the EU's opinion, this made the regulatory situation overly complex

and less transparent.

The EU noted that the draft provided for the mandatory indication of certain elements (e.g. denomination, commercial brand) on the main label, which would oblige economic operators to redesign the labels specifically for the Brazilian market. Brazil was requested to consider allowing all elements other than the trade mark to be shown on the back label, or to clarify whether specific wine and spirits regulations already provided for that exception. In addition, what was the

rationale behind the provision that the product denomination must be written horizontally and with a minimum size, as well as the mandatory indication of the list of ingredients? In relation to the alcohol content, the EU asked Brazil to consider allowing the use of different expressions for the alcohol content, in accordance with OIV standards.

The EU invited Brazil to take into account its concerns during the preparations of the final resolution and to reply to its written comments; to report on the state of play of the adoption procedure; and to apply to the greatest possible extent the international standards adopted by the

OIV.

The representative of Brazil clarified that the process relating to this ordinance was still in progress and that it had been conducted in a very transparent manner, in accordance with the TBT Agreement. He said that in 2017, two public consultations had been conducted on this draft technical resolution, both of which had been notified as G/TBT/N/BRA/719 and G/TBT/N/BRA/719/Add.1. Addressing the EU's request, he reported that Brazil had extended the

comment period of the second public consultation for an additional 37 days beyond the 60 days

established at the draft. All comments from the EU were under analysis by the technical authorities of the Ministry of Agriculture of Brazil.

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4.3.2 India — Testing and certification of telegraph (The Indian telegraph (Amendment) Rules, 2017), G/TBT/N/IND/66

The representative of the United States raised concerns regarding India's scheme for testing and certification of telecom equipment. The full statement is contained in G/TBT/W/540.

The representative of India said that the scheme of Testing and Certification of Telegraph (The Indian Telegraph (Amendment) Rules, 2017), notified as G/TBT/N/IND/66, was intended to

ensure user safety and security of the network. He underlined that the scheme was non-discriminatory with respect to Original Equipment Manufacturers as it did not restrict testing to Conformity Assessment Bodies (CABs) located in India (Telecom Engineering Center (TEC)-designated labs) but also allowed testing from internationally recognized CABs located in Mutual Recognition Agreement (MRA) partner countries worldwide. He informed that test results from ILAC-accredited labs would be accepted up to 31 March 2019, in order to offer flexibility in

response to demands from industry. Regarding the concern of possible overlapping certification requirements for a few products under the Compulsory Registration Order and under the Indian Telegraph (Amendment) Rules 2017, India reported that the issue was being examined and would be settled prior to implementation of the scheme, assuring that industry would not be subjected to duplicate testing.

4.3.3 United States – TSA certification on security screening equipment

The representative of China expressed concern that ever since 2014, Chinese companies

which applied for TSA certification on civil aviation security screening equipment had been treated unequally compared to US domestic companies or those in other Members. Her delegation considered that the TSA had applied the certification process in an unpredictable and unclear manner, creating a trade obstacle to Chinese exporters. She said that in the process of certification, TSA had failed to inform Chinese companies of the deficiencies and results in a precise and complete manner, as required by Article 5.2.2 of the TBT Agreement, and Chinese

companies had no chance to make corrections.

Secondly, as no relevant guide or recommendation had been issued by an international standardizing body and as this conformity assessment procedure had a significant effect on trade of other Members, China hoped that the US would make prior notification of the TSA certification measure to the TBT Committee and allow Members to make comments. Thirdly, according to Article 5.1.2, conformity assessment procedures should not be prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade; however, in

China's view, TSA certification was undertaken in an unpredictable, unclear manner, having negative impacts on China's exports and creating unnecessary obstacles to international trade. China hoped that the US would follow the relevant rules in the TBT Agreement, notifying this certification, treating Chinese companies and products equally to domestic or other Members' companies and products, and not creating unnecessary obstacles to trade.

The representative of the United States said that China's concerns, also raised bilaterally,

would be relayed to TSA. She stated that the TSA Security Screening Equipment Certification

related to procurement of security screening devices by TSA and therefore was not a matter for discussion under the TBT Agreement.

4.3.4 United States - Energy Conservation Program: Energy Conservation Standards for Compressors, G/TBT/N/USA/1132, G/TBT/N/USA/1132/Add.2

The representative of China appreciated efforts made by the US in energy-saving, but was concerned that some of the requirements prescribed in the regulation were inconsistent with relevant ISO standards and greatly impacted Chinese exports. China had submitted comments to

the US on the regulation in 2016 but had received no response. Her delegation requested a scientific explanation for the methods of classification and energy-efficiency descriptions used for air compressors. China also sought clarification of its concerns on technical content in order to avoid unnecessary obstacles to trade.

The representative of the United States said that beyond the brief technical comments submitted on 8 August 2016, this was the first time China had expressed concerns on this

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measure in the WTO, as well as bilaterally that morning. She reported that the US Department of Energy (DOE) had responded to all substantive comments received in the US federal register upon announcement of the final rule. The US had notified the measure as G/TBT/N/USA/1132 on 20 May 2016, followed by addenda thereto on 23 June 2016 and 18 November 2016. The rule had been finalized on 16 December 2016 and the effective date of the test procedure regulations had been delayed until 3 July 2017. Her delegation would convey the remaining concerns to the DOE.

4.3.5 Indonesia — Regulation of the Chairman of NADFC RI No.14 of 2016 on The Safety and Quality Standard of Alcoholic Beverages, G/TBT/N/IDN/110

The representative of Mexico raised concerns on the regulation, notified on 31 August 2016 in document G/TBT/N/IDN/110, establishing the safety and quality criteria, and the labelling and advertising requirements for domestically produced and imported alcoholic beverages distributed in Indonesia. She said that according to safety standards in the regulation, the maximum

methanol content in alcoholic beverages should not exceed 0.01% of the volume of the product. The regulation also included a definition of tequila and recognized the regulations applicable to this product, as well as its physico-chemical parameters. Her delegation was therefore concerned about the uncertainty and lack of clarity with regard to whether the regulation's maximum permitted level of methanol in alcoholic beverages applied to Mexican tequila, as the provisions of the regulations applicable to tequila allowed for higher maximum methanol levels.

Furthermore, the regulation included provisions prohibiting any type of advertising in any

media, thus restricting advertisements, and displays of alcoholic beverages at authorized points of sale. Her delegation was concerned that this provision could infringe Article 2.2 of the TBT Agreement of the WTO, as it indirectly affected the advertising and marketing of this type of product in Indonesia and created unnecessary barriers to trade.

In light of the above, Mexico requested Indonesia to: (i) clarify whether the maximum permitted level of methanol established in the regulation also applied to tequila; and (ii) explain

the logic behind the implementation of restrictive measures on the advertising of alcoholic

beverages.

The representative of Indonesia thanked Mexico for their bilateral meeting held the previous day. His delegation would consult with relevant authorities in Indonesia on Mexico's calculation of alcohol levels and revert with a more detailed explanation in a future meeting. Regarding limiting publicity for alcoholic beverages, it was his delegation's understanding that the regulation had been created as one of the tools to support public morals in Indonesia, currently

home to the largest Muslim population. He confirmed that limitation of publicity applied to alcoholic beverages regardless of their origin.

4.3.6 Colombia — Technical Regulation applicable to zinc-carbon and alkaline cells and batteries imported into or manufactured in Colombia, G/TBT/N/COL/228, G/TBT/N/COL/228/Add.1

The representative of Mexico noted that it had not submitted comments during the public consultation period for this draft regulation, notified on 13 September 2017 as G/TBT/N/COL/228,

as it had not identified any sensitive issues that might affect Mexican industry. However, the final regulation issued through Resolution No. 721 on 16 April 2018 (notified in G/TBT/N/COL/228/Add.1), expected to enter into force nine months after publication, contained provisions which indirectly affected Mexican industry, in particular the toy industry, absent from the draft regulation initially notified in 2017. She said that Mexico's concern related to the last paragraph of Article 3 of the resolution, which stipulated that not only must such batteries and cells be certified in order to comply with the regulation in question, but that they must also be

removed from products. The Mexican toy industry used the "try me" system, enabling users to test products before purchasing them. She noted that if batteries and cells had to be removed from battery-powered products, this system would cease to work.

Mexico was of the understanding that Colombia was the only country to have such a

requirement, meaning that it would no longer be possible for the toy industry to carry out one type of production process to meet regional requirements, thus forcing industry to establish a special

production process for Colombia, and considerably increase costs. In light of Article 2.2 of the TBT

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Agreement, Mexico considered that this requirement would create an unnecessary barrier to trade, as the inclusion of batteries and cells in products (provided such batteries and cells were certified) would not be misleading and would not jeopardize human life, health, or safety, animal or plant health, or the environment.

Furthermore, based on Article 2.9.2 of the TBT Agreement, although the draft regulation met the requirement concerning notification to the TBT Committee and providing a consultation

period, it had not included, from the outset, the provision on battery removal, indirectly impacting on all imported products that included such batteries and cells. While emphasizing that Mexican industry was in favour of the requested certification of batteries and cells, but was opposed to their removal from imported products, Colombia was requested to consider revising its regulation to allow for battery-powered products to be imported together with batteries and cells, provided such batteries and cells were certified, as this did not affect the fulfilment of the legitimate objective

stated by Colombia.

The representative of the United States expressed support for Mexico's comments.

The representative of Colombia expressed concern that Mexico had not informed Colombia's TBT contact point that it would be raising this STC, as per common practice. She underlined that Colombia had notified the draft technical regulation on 13 September 2017 in document G/TBT/N/COL/228 with a comment period of 90 calendar days, thereby complying with Article 2.9.2 of the TBT Agreement and observing the principle of transparency. She did however

note that Colombia had not received comments or observations from Mexico regarding the published draft, bearing in mind that the Ministry of Commerce, Industry and Tourism had made the regulatory impact analysis for zinc carbon and alkaline cells and batteries publicly available on its website2 and that the draft technical regulation had also been submitted for public consultation nationally and internationally. As the measure had already been adopted (the relevant administrative decision had been notified in document G/TBT/N/COL/228/Add.1) and would enter into force in January 2019, Mexico was invited to submit any comments to Colombia officially.

4.3.7 Ecuador — RTE INEN 088 (1R) Surface tension agents, G/TBT/N/ECU/117/Rev.1

The representative of Mexico raised concerns about the draft Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 088 (1R), "Surface tension agents" notified to the TBT Committee on 6 March 2018 in document G/TBT/N/ECU/117/Rev.1, for which the public consultation process had ended on 27 May 2018. The draft regulation established the requirements to be met by surface tension agents intended for use, with a view to protecting the environment

and preventing practices likely to mislead end users.

Her delegation was concerned that the draft technical regulation only recognized one test method to demonstrate compliance with the biodegradability requirement and one method to determine the phosphate content, despite the international recognition of several methods to demonstrate the compliance of both requirements. Concerning biodegradability, the draft regulation only recognized tests carried out on the final product whereas internationally, both tests

on the final product and tests on ingredients were recognized. Mexico believed that by recognizing

tests on ingredients, it would be possible to eliminate tests on certain groups of ingredients the properties of which had been proven at international level to be biodegradable, which would prevent both the duplication of tests and increased costs in the certification processes prior to exportation. She explained that this type of "filter" had been implemented in Mexican Standard NMX Q 901 CNCP 2016. Concerning phosphate content, the draft regulation also only allowed for one test method. Mexico considered that by accepting only one of the many internationally recognized methods in order to meet the aforementioned requirements, the draft regulation may

be creating a technical barrier to trade, as it appeared to violate Articles 2.2 and 2.3 of the TBT Agreement, insofar as it established requirements that may be more trade restrictive than necessary.

Mexico was also concerned that the provision that conformity assessment tests must be conducted through an accredited certification body in Ecuador could be in violation of Article 5.1 of

2 http://www.mincit.gov.co/minindustria/loader.php?lServicio=Publicaciones&id=31712

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the TBT Agreement, as the draft regulation imposed more restrictive conformity assessment processes for imported products.

In light of the above, Ecuador was requested to: (i) allow for compliance with the biodegradability requirement to be demonstrated through the two internationally recognized test methods (tests on the final product and on surfactants), thereby preventing the duplication of tests by exempting groups of surfactants that had proven to be biodegradable from further tests;

(ii) include all internationally recognized tests proven to demonstrate biodegradability and phosphate content, or provide a rational explanation for not including them; and (iii) accept declarations of conformity from providers and/or recognize tests conducted by foreign conformity assessment bodies.

The representative of Ecuador noted that whilst no comments had been received from Mexico before the deadline, comments by several other Members had been taken into account and

would be implemented, such as the establishment of a biodegradability percentage that could go up to 70% replacing the 90% notified; the establishment of an additional six-month period for entry into force of the regulation; and related to one of the concerns expressed by Mexico, the inclusion of various testing methods to determine the content of phosphates and the level of biodegradability. Regarding the concern on conformity assessment bodies, her delegation would consult with capital. Ecuador remained available to continue to work bilaterally on this issue.

4.3.8 Indonesia National Standard SNI 2973: 2011 and certification requirements for

the import of biscuits, G/TBT/N/IDN/105, G/TBT/N/IDN/105/Add.1

The representative of Switzerland expressed concern regarding the Indonesian National Standard SNI 2973: 2011 and certification requirements for the import of biscuits, as notified to the TBT Committee on 20 April 2016. Switzerland was concerned that should they be implemented, the prohibitive requirements would drive Swiss companies out of the Indonesian market as they exported quality products in small quantities. His delegation had submitted

comments and questions in November 2017 and noted that an answer had only recently been

provided during the meeting. He thanked Indonesia for this answer, confirming the postponement of the measures, and asked Indonesia in addition to provide an update on the regulatory development of these measures and confirm whether they would be implemented at a later stage or withdrawn. A timeline of the implementation of the requirements was also requested. Switzerland thanked Indonesia for bilateral exchanges held on this issue and looked forward to further cooperation and the additional clarifications as requested by Switzerland during the

meeting.

The representative of Indonesia confirmed that the measure had already been postponed, as notified in G/TBT/N/IDN/105/Add.1, dated 21 September 2016.

4.4 Previously raised concerns

4.4.1 India — Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20, G/TBT/N/IND/40 (IMS ID 1333)

The representative of the European Union reiterated previously raised concerns4 and asked

India to engage in a dialogue to resolve the outstanding issues, i.e. the ISI marking fee and the USD 10,000 bank guarantee.

The representative of India repeated the response provided at the previous Committee meeting5 regarding the amount of the marking fee, the requirement of a bank guarantee and the Scheme for Testing & Inspections and expressed his willingness to discuss any outstanding issues with the Members concerned.

3 For previous statements follow the thread under IMS ID 133 (under dates raised and references). 4 G/TBT/M/74, para. 2.52 and statement circulated in full in G/TBT/W/477. 5 G/TBT/M/74, para. 2.54.

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

The representative of Japan once again recalled China mentioning during previous meetings that the "Guidance for Application and Evaluation of New Cosmetic Ingredients" would be revised in accordance with the revision of "Regulations concerning Hygiene Supervision over Cosmetics". He noted that the regulation was listed in the legislation plan for 2018 released by the State

Council and the China Food and Drug Administration (CFDA). China was asked to share details about the revision schedule and to provide a sufficient period of time prior to entry into force and sufficient time for public comments. Japan also reiterated previously raised concerns on examination, safety evaluation requirement and information disclosure.7

The representative of the European Union reiterated his delegation's request for an update on the status and planned adoption date of revisions to the Provisions for the Administration of

Cosmetics Application Acceptance.

The representative of Switzerland supported the comments of Japan and the EU.

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

4.4.3 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"), G/TBT/N/IND/66 (IMS ID 2748)

The representative of the European Union reiterated previously raised concerns.9 The full statement is contained in G/TBT/W/553.

The representative of the United States reiterated previously raised concerns.10

The representative of Japan remained concerned with the Unified Access Service License Agreement, requesting India to ensure that its telecom regulations did not impede market access for foreign industries. Japan also reiterated its request that the regulations be implemented in a transparent manner in terms of testing methods and certification requirements.

The representative of Canada continued to be concerned with India's in-country security testing requirements and reiterated previously raised concerns.11

The representative of India reiterated some of the points raised in previous meetings12 and

provided inputs on India's notification G/TBT/N/IND/66 submitted on 6 December 2017. Telecom networks were a part of the critical infrastructure on which other critical infrastructures like power, transportation and defence relied on. He again clarified that India would rely on international standards to the extent possible. For IT products, testing carried out against Common Criteria (CC) Process under the Common Criteria Recognition Arrangement (CCRA) would be leveraged. However, additional tests could be conducted, if required in the interests of the public and of

national security. India recalled its earlier interventions mentioning that the CC process was based on and used for certifying the claims of a vendor about the security features incorporated in the product without certifying that it had no vulnerabilities or backdoors. He specified that CC certification did not address national concerns on the security requirement of telecom networks.

6 For previous statements follow the thread under IMS ID 296 (under dates raised and references). 7 G/TBT/M/74, para. 2.57. 8 For previous statements follow the thread under IMS ID 274 (under dates raised and references). 9 G/TBT/M/74, para. 2.60. 10 G/TBT/M/74, para. 2.62. 11 G/TBT/M/70, para. 2.68. 12 G/TBT/M/70, para. 2.64.

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Concerning the in-country testing requirement and the security certification thereof, it was noted that these guidelines could not be treated as trade barriers in view of the fact that the guidelines were equally applicable to the manufacturers and vendors irrespective of the source of procurement, including domestic manufacturers.

India also noted that it had published its Mandatory Testing and Certification of Telecommunication Equipment (MTCTE) on 5 September 2017 contained in Notification No G.S.R.

1131(E), which would enter into force on 1 October 2018. Meanwhile, it had also been notified in G/TBT/N/IND/66 on 6 December 2017. Under the scheme, all telecom equipment, whether imported or indigenously manufactured, was required to be tested and certified against Essential Requirements (ERs) notified by Telecom Engineering Centre (TEC). The ERs included EMI/EMC, safety, technical requirements, specific absorption rate (SAR) requirements and security requirements.

He explained that the testing was carried out with the objective of ensuring that the radio frequency emissions from the equipment were within the limits, the equipment did not degrade the performance of the network to which it was connected, and that it complied with the relevant national regulations. Quality and performance were not tested and certified under MTCTE. The ERs were based upon international standards with suitable modifications so that they were in compliance with Indian requirements and regulations. The testing of telecom products was to be carried out in Indian Accredited Labs designated by TEC, called designated CABs, or recognized

CABs of MRA partner countries. TEC was required to issue certificates based on their test reports. A surveillance mechanism was also included in the scheme. The dates of entry into force of security testing of telecom products had been aligned and would take effect from 1 October 2018.

4.4.4 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 48913)

The European Union reiterated previously raised concerns with respect to the above-mentioned measures.14 The full statement is contained in G/TBT/W/554.

The United States supported the EU's statement referred back to their own statement from the March 2018 Committee meeting.15

The representative of Japan supported the statements of the EU and US. Japan remained concerned about the "Regulation on the Administration of Commercial Cipher Codes" and the "Multi-Level Protection Scheme (MLPS)". At the previous meeting, China had explained that it would continue to revise the Regulations on Commercial Cryptography according to the Law on Cryptography after its promulgation, and that the regulations on the cybersecurity MLPS were being drafted to fulfil the requirements of the Cybersecurity Law. Japan requested China to provide

information regarding the revision process of both regulations. In addition, Japan requested China

to notify the revision of these regulations to the WTO in order to provide Members with opportunity for comment.

The representative of Australia supported concerns expressed by other Members regarding the proposed Insurance Regulatory Commission and Information and Communication Technology Regulation, and referred to previous statements in this regard.16 He understood China's desire to protect ICT infrastructure, but Australia nevertheless questioned whether the proposed measures were more trade restrictive than necessary. Australia asked for more information from China on

the status of the regulations and whether they would be permanently withdrawn.

13 For previous statements follow the thread under IMS ID 294, IMS ID 457 and IMS ID 489 (under

dates raised and references). 14 G/TBT/M/74, para. 2.65. 15 G/TBT/M/74, para. 2.66. 16 G/TBT/M/74, para. 2.68; G/TBT/M/73, para. 2.22; G/TBT/M/72, para. 3.75; G/TBT/M/71, para.

2.162; and G/TBT/M/71, para. 2.175.

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The representative of China said that it was organizing the revision of the regulations on Commercial Cryptography to further reduce the administrative licences, and strengthen supervision in the whole process. The revision of the regulation on Commercial Cryptography was still being researched. After the promulgation of the Law on Cryptography of the People's Republic of China, China would continue to revise the regulation on Commercial Cryptography according to the Law on Cryptography, and release the regulation for public consultation at an appropriate

time.

Regarding the MLPS, the Cybersecurity Law stipulated that China would carry out the cybersecurity MLPS based on the experience of past years. To fulfil the requirements in Cybersecurity Law, the regulation on the cybersecurity MLPS was currently being drafted; it would replace the former administrative measures on information security MLPS. When completed, the regulation would be open for comments. Regarding banking, the Guideline for Promoting the

Application of Secure and Controllable Information Technology in Banking Sector (2014-2015) had

been suspended in April 2015, and had already expired. China would always abide by its WTO commitments and be open and transparent in drafting the measures for commercial banking information system. On the issue of insurance, the CIRC's regulation was still at the drafting stage. It was stressed that during this whole process, China had been open, transparent, and had made notifications to the WTO. All the comments had been studied and evaluated and, in parallel, bilateral communications and consultation had been conducted.

4.4.5 Russian Federation — Draft Technical Regulation on Alcohol Drinks Safety (published on 24 October 2011), G/TBT/N/RUS/2 (IMS ID 33217)

The representative of Ukraine reiterated previously raised concerns18 and asked Russia to provide the Committee with a practical update on this regulation, including on any modifications made.

The representative of the European Union reiterated previously raised concerns19 and again

requested Russia to notify the revised text to the TBT Committee, if the draft measure had been

modified and included substantial changes.

The representative of Guatemala recalled Russia's statements at the November 2017 and March 2018 meetings20 that internal work was underway within the Eurasian Economic Union to consider comments received on this technical regulation. Guatemala requested Russia to provide information on the current situation and asked whether there had been any progress in the discussions. Additionally, Guatemala asked for a tentative date for the final version of the draft.

She asked whether the final version of the draft would be notified to the WTO and when the measure would enter into force.

The representative of the Russian Federation repeated the responses provided at previous Committee meetings 21 and said the board of the Eurasian Economic Commission may approve the draft technical regulation by the end of this summer. After the approval, the draft would be published on the web site of the Commission. In addition, Russia offered to send the draft to

interested WTO Members, and inform them of any further developments regarding the adoption of

the technical regulation.

17 For previous statements follow the thread under IMS ID 332 (under dates raised and references). 18 G/TBT/M/74 para. 2.72; G/TBT/M/73, para. 2.26; G/TBT/M/72, para. 3.81; and G/TBT/M/71, para.

2.79. 19 G/TBT/M/74 para. 2.73; and G/TBT/M/73 para. 2.27. 20 G/TBT/M/74, para. 2.75; and G/TBT/M/73, para. 2.30. 21 G/TBT/M/74, para. 2.75; and G/TBT/M/73, para. 2.30.

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4.4.6 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, G/TBT/N/KOR/775 (IMS ID 30522)

The representative of the United States raised concerns regarding Korea's regulation on registration and evaluation of chemical material. The full statement is contained in G/TBT/W/542.

The representative of the Republic of Korea said that the new K-REACH amendment had been approved in the National Assembly and published on 20 March and that it would enter into force on 1 January 2019. It was not possible to delay further the effective date of the amended K-REACH. The draft enforcement decree and rules for implementation had been notified to the WTO under G/TBT/N/KOR/775 on 11 June 2018. Consequently, interested parties including foreign stakeholders could still submit any comments they had. Second, with regard to concerns on

Confidential Business Information (CBI), he invited the US to send detailed information on relevant cases in writing so that they could be delivered to the Ministry of Environment for a thorough investigation. Anonymous, simplified or modified information could be provided for their consideration in order to address concerns regarding exposure of companies. Lastly, all current acts were available in Korean through the website "The National Law Information Center". Korea had also taken note of other comments, which would be conveyed to the relevant authorities. Korea expressed its readiness to communicate transparently with any interested parties, including

the US, to resolve the concerns raised.

4.4.7 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 32823)

The representative of the European Union reiterated previously raised concerns24 regarding the review of the Regulation of Minister of Industry No. 55 revising Regulation of Minister of

Industry No. 24, which concerned the mandatory implementation of SNI (Indonesia national

standard) for Toys. With respect to the separate ongoing revision/update of SNI on toys, he recalled Indonesia's explanation at the previous meeting that consensus among stakeholders had already been reached at technical level and that the issue was now up for consultation at national level through e-bulletin. The revised SNI would then become the basis for the revision of the Ministerial Regulation. In addition, he expressed his delegation's hope that this ongoing review would also remove the different treatment concerning testing requirements for imported and

domestically produced toys. Instead, he stated, the system should provide for the same testing methods and the same validity of test reports for domestic products and for products imported from the same factory (currently six months validity).

The representative of Japan expressed support for the position of the EU. After noting that in previous meetings Indonesia had explained that the draft Ministerial Regulation was still under review, he asked Indonesia to notify the revised measure promptly. He asked whether the proposed drafts of these revisions were subject to public comments under the Indonesian

procedure. He also requested Indonesia to provide, in accordance with TBT rules, sufficient time until the date of entry into force of this measure, once adopted.

He noted that since the end of April 2016, economic operators had not been able to use overseas laboratories, resulting in an increase in testing costs and serious delays for exports. Japan thus requested Indonesia to revise its laboratory accreditation requirements for overseas laboratories and accept the testing results conducted by these laboratories. As noted by the US delegation at the last meeting, it could have been the case that some overseas laboratories were

approved to conduct toy testing under agreement with LSPro. Japan asked Indonesia whether this was the case, and, if so, requested Indonesia to officially announce the names of such laboratories. Regarding testing frequency, Japan said that, while testing was imposed every six months for domestic products, for imported products it was on "each–and-every import shipment".

22 For previous statements follow the thread under IMS ID 305 (under dates raised and references). 23 For previous statements follow the thread under IMS ID 328 (under dates raised and references). 24 G/TBT/M/74, para. 2.78 and statement circulated in full in G/TBT/W/482.

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Japan considered these different testing frequencies to be discriminatory and requested Indonesia to revise them.

The representative of the United States expressed her delegation's support for the comments from the EU and Japan.

The representative of Indonesia reported that it was currently in the process of revising national standards of toy safety based on international standards by the ISO. The balloting process

had been conducted in the beginning of March 2018. The regulation revision process had started in June 2017 and several public consultations to capture stakeholders' concerns had taken place.

4.4.8 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/EEC/264, G/TBT/N/EEC/264/Add.1, G/TBT/N/EU/571 (IMS ID 34525)

The representative of the United States once again raised concerns with the EU's revisions to this draft regulation and the persistent failure by the EU to provide information on the pending applications for traditional terms. The US noted that while the EU had notified revised draft regulations on wine labelling, including geographical indications and traditional terms, it remained unclear whether and how these revisions were related to the delays in pending applications. Could the EU confirm that the 11 pending US applications for traditional terms would continue to be

governed by existing regulations and not be subject to these draft regulations when finalized? If this indeed was the case, what was the reason for the eight-year delay in processing the applications? The US was reviewing the notified regulations and would submit comments, but from an initial review the revisions did not appear to include changes that would ensure that the current delays could not happen again. She again asked the EU to commit to expediting US applications and process them in a transparent and timely manner. The US was also concerned about a lack of

clarity in the revised draft regulations regarding the kind of rules or legislation that the

Commission would consider the "same or equivalent" as those provided in EU member States. These factors could impact the ability of producers to use certain words on their labels. She sought clarity from the Commission on this issue. At the previous TBT meeting the US had asked the EU whether the Commission was processing applications from member States, specifically France and Croatia, but not from trading partners. She again asked the EU to confirm whether they were reviewing member State applications and, if so, why these applications were being processed but

not others.

The representative of Argentina reiterated its concerns regarding the EU's unjustified delay in resolving this specific trade concern, which Argentina and other Members had been raising for some ten years. The full statement is contained in G/TBT/W/549.

The representative of Brazil reiterated previously raised concerns.26

The representative of the European Union said that the EU had undertaken an internal assessment on traditional terms with stakeholders and experts from the member States (in

accordance with Article 114(3) of Regulation (EU) No 1308/2013 establishing a common organization of the markets in agricultural products). This was now part of the Draft Commission Implementing Regulation (EU) laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council, recently notified in G/TBT/N/EU/571. As the pending applications for traditional terms were still under consideration, no precise timeline could be provided.

25 For previous statements follow the thread under IMS ID 345 (under dates raised and references). 26 G/TBT/M/74, para. 2.85.

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4.4.9 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 36727)

The representative of the Republic of Korea reiterated previously raised concerns, in particular concerning acceptance of laboratory test results.28

The representative of the European Union restated his delegation's interest in particular in the further simplification of the compulsory registration scheme and the wider acceptance of foreign test results as a basis for the registration and reiterated previously raised concerns.29

The representative of the United States reiterated previously raised concerns with respect to India's Compulsory Registration Order (CRO) requirements.30

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

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

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

In response to the comments made by Members, the representative of India recalled the statement made by his delegation at the previous meeting31 and flagged the latest relevant

notifications to the Committee.32

4.4.10 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 39333)

The representative of the United States continued to raise concerns regarding the EU's hazard-based approach to regulating substances identified as endocrine disruptors. The full

statement is contained in G/TBT/W/541.

The representative of Canada raised concerns with the hazard-based approach on the regulation of active ingredients. Hazard-based cut-offs, without giving any consideration to exposure or without performing a complete risk assessment appeared to be at odds with WTO commitments. There were a growing number of examples where active ingredients were prevented from going through the entire re-authorization process in the EU due to these hazard-based cut-

offs. The EU's proposed criteria for identifying compounds as endocrine disruptors was also of concern. The European Chemical Agency classification decisions could trigger regulatory non-

approval and default maximum residue limits (MRLs), regardless of actual risk, in the opinion of the European Food Safety Authority. Canada was disappointed that the regulatory amendment for derogation based on negligible risk originally notified to the WTO in 2016 was not included in Commission Regulation (EU) 2018/605. Without the inclusion of this technical amendment, default MRLs for food and feed were required once a substance was identified as an "endocrine disrupting

chemical", regardless of actual risk under real world exposure scenarios.

As previously expressed at the TBT and SPS Committee meetings and in Brussels, Canada remained deeply concerned with the EU's movement towards a hazard-based approach for regulatory decisions for pest control products. This was at odds with good regulatory practice and

27 For previous statements follow the thread under IMS ID 367 (under dates raised and references). 28 G/TBT/M/74, para. 2.88. 29 G/TBT/M/74, para. 2.87 and statement circulated in full in G/TBT/W/484. 30 G/TBT/M/74, para. 2.89. 31 G/TBT/M/74, para. 2.92. 32 G/TBT/N/IND/47, G/TBT/N/IND/47/Add.1, G/TBT/N/IND/47/Add.2 and G/TBT/N/IND/47/Add.3. 33 For previous statements follow the thread under IMS ID 393 (under dates raised and references).

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not in line with the EU's WTO obligations. While Canada agreed that hazard identification of a chemical was an important first step in the scientific risk assessment framework, it was imperative that potential adverse effects be put into context with consideration of potency, and the level of likely human and environmental exposure based on the conditions of use. Canada sought concrete assurance from the EU that decisions on setting MRLs and import tolerances would continue to be made based on complete risk assessment as set out in Regulation 396/2005. Canada did

appreciate the consultations undertaken by the EU and requested that detailed information be shared with trading partners on how its revised measure would work, ensuring it was consistent with international trade obligations.

The representative of Argentina reiterated concerns with respect to the approach taken by the EU in identifying substances with endocrine disrupting properties. The full statement is contained in G/TBT/W/550.

The representative of Israel informed the Committee that there had been continuous exchanges with the EU on this matter. While Israel shared the objectives of health and the environmental protection, the European Commission should maintain a risk-based approach to setting MRLs consistent with its TBT and international obligations. Israel expressed strong concern regarding the uncertainty of the pending renewals and possible impacts on MRLs and import tolerances for many plant protection products under existing legislation.

The representatives of Costa Rica, Brazil, Panama, Colombia, Guatemala and Thailand

supported the concerns raised by other delegations and reiterated concerns raised in previous Committee meetings.34

The representative of India joined other Members' concerns on the EU Regulation. While globally, risk-based approaches were used in regulating pesticides, some countries required both hazard- and risk-based approaches in decision-making. Departure from fundamental principles of the scientific risk assessment framework without identifying the actual risk would have significant

adverse consequences for sustainable agricultural production due to removal of many crop

protection tools from the market despite their established safety in use. Further, different risk management responses by countries in regulating endocrine disrupting chemicals as pesticides might not lead to any food safety gains but would lead to trade disruption. It was necessary to develop guidelines when taking risk management decisions which facilitated Members and didn't create unnecessary obstacles to trade. India requested the EU to withdraw the hazard-based measure.

The representative of Australia remained interested in the EU's proposed approach for regulating pesticides, including approaches for regulating endocrine disrupting chemicals (EDCs), and the herbicide glyphosate. He thanked the EU for its ongoing engagement with Australia on these issues and looked forward to continuing their constructive engagement. In April 2018, the European Commission adopted a new regulation setting criteria for the identification of endocrine disruptors used in pesticides which would apply from 10 November 2018 to all new substances subject to an approval or a renewal of approval in the EU. Australia understood that the EU

legislation for plant protection products provided that active substances which are endocrine disruptors would not be approved, unless there was negligible exposure, in which case they may be approved under restricted conditions. The technical amendment to the clause of negligible exposure for plant protection products envisaged in 2016 had been put on hold until the adoption of the criteria for identification of endocrine disruptors. Now that the criteria had been adopted, Australia requested that the EU provide information on plans to resume discussions on this amendment.

The representative of New Zealand echoed the concerns raised by other Members and thanked the EU for their exchanges of information to date. Concerns remained that the EU hazard-based approach to regulating substances identified as endocrine disruptors could be an unnecessary barrier to trade. She requested an update from the EU on the derogation and any plans on its progress.

34 G/TBT/M/73, para. 2.51; and G/TBT/M/74, paras. 2.99, 2.96, 2.102, 2.103 and 2.100, respectively.

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The representative of the European Union thanked Members for their interest in the ongoing work in the EU on defining criteria to identify endocrine disruptors both for plant protection products and biocides. She was pleased to announce that scientific criteria were now in place to identify endocrine disruptors for biocides and pesticides. The new criteria would be applicable – also to on-going processes for the approval or renewal of approval of active substances - from 7 June 2018 (biocides) and from 10 of November 2018 (pesticides). They were set via Delegated

Regulation (EU) 2017/2100 and Regulation (EU) 2018/605 for biocides and pesticides, respectively, which had been notified under the TBT Agreement. The criteria for pesticides and biocides were the same in practice and thus ensured a harmonized approach and were based on the WHO definition of endocrine disruptors. They required consideration of all relevant scientific information (including scientific publications), as well as the application of a weight of evidence approach. As regards the act including the technical amendment to the clause on negligible

exposure for plant protection products, the Commission intended to resume discussions with EU member States at the meeting of the Standing Committee on Plants, Animals, Food and Feed on

19/20 July. A guidance document for the implementation of the adopted criteria had been finalised by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) and published on their websites. The EU reiterated its commitment to act in full transparency and would keep Members duly informed about further developments.

4.4.11 Russian Federation — Safety of products for children and adolescents,

G/TBT/N/RUS/29 (IMS ID 41835)

The representative of the European Union continued to raise concerns regarding Russia's measure on the safety of products for children and adolescents. The EU renewed its request for information about the time-frame needed for the adoption and entry into force of the amendments. He also recalled his question on what was exactly meant by "artificial leather" and what materials it covered. The EU also asked whether its comments had been taken into account and expressed interest in receiving the final adopted text once available.

The representative of the Russian Federation informed the Committee that the decision had been published on the website of the Commission on 25 September 2017 and would come into force on 25 September 2018. The amendments prohibited the use of artificial leather in insoles for children's shoes. Russia defined "artificial leather", in accordance with the EAEU related standard, as a fabric coated or impregnated with a polymer or composition of polymers. However, the use of other artificial materials (for example, textiles) in insoles for children's shoes was allowed.

4.4.12 Thailand — Draft Notification of the Alcoholic Beverages Control, Re: Rules, Procedure and condition for Labels of Alcoholic Beverages, issued under B.E., G/TBT/N/THA/437 (IMS ID 42736)

The representative of the European Union continued to have concerns over the Rules, Procedure and condition for Labels of Alcoholic Beverages. The full statement is contained in G/TBT/W/555.

The representative of the United States, whilst supporting Thailand's efforts to manage the

public health challenges associated with excessive alcohol consumption, continued to raise concerns about the trade impacts of Thailand's regulation on the labelling and packaging of alcoholic beverages. The US requested a status update on consultations on the regulation guidelines, flagged by Thailand at the previous Committee meeting, and asked whether stakeholders could engage in them. Thailand was asked for the location of the publication of a preliminary assessment of warning labels for alcoholic beverages, also mentioned at that meeting. Her delegation once again asked for an update on Thailand's plans with respect to such labels and

requested that any proposed changes to alcohol labelling regulations be notified to the TBT Committee to provide trading partners with the opportunity to comment before those regulations were finalized.

35 For previous statements follow the thread under IMS ID 418 (under dates raised and references). 36 For previous statements follow the thread under IMS ID 427 (under dates raised and references).

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The representative of Japan shared the concerns raised by the EU and US delegations, and requested an update on scheduled consultations and that Members' comments on the measure be taken into account.

The representative of Australia reiterated previously raised concerns about the Rules, Procedure and Condition for Labels of Alcoholic Beverages.37

The representative of Argentina shared the concerns raised by other Members. Argentina

was paying closer attention to developments in the implementation of the standard and asked Thailand to provide new information on the measure.

The representative of Guatemala recognized the need to protect the health of consumers and the legitimate objective of Thailand to reduce alcohol consumption in its population. However, Guatemala considered that the measure may be more trade restrictive than necessary. At the

previous Committee meeting, Thailand had informed that they would conduct consultations in May 2018. Guatemala asked whether there was a report on those consultations and whether another public consultation would be organized.

The representative of New Zealand reiterated previously raised concerns on the Rules, Procedure and Condition for Labels of Alcoholic Beverages.38

The representative of Chile echoed the concerns raised by other Members and requested detailed information on the next steps from new public consultations, if planned, to entry into

force.

The representative of Thailand updated Members on progress on the technical document of the regulation on the labelling control of alcoholic beverages. Thailand recalled its focus on two priorities: (i) revision of the second version of the technical document; and (ii) evaluation plan of the regulation. He noted that the revision was in the stakeholder consultations phase and that

three planned consultation sessions had been completed a couple of weeks previously. All interested parties, including the private sector, foreign embassies, governments and civil society

organizations had joined group discussions. Thailand was currently compiling and reviewing all submitted comments and would officially publish them on the website of the Office of Alcohol Control Committee. In addition, those comments would be proposed to the responsible working group and committees, to consider further improvement of the technical document.

Finally, he informed Members that Thailand had posted the primary evaluation of the technical regulation on the websites of the Center for Alcohol Studies of Thailand and the Office of

Alcohol Control Committee. The evaluation concluded that pictorial warning labels on alcoholic beverages had a significant impact on consumers' decision-making for buying alcoholic beverages in Thailand. Photos of movie stars, performers, singers and athletes particularly attracted the attention of consumers. The referred regulation had been in effect for two and a half years, thus another evaluation – a long-term impact assessment in various aspects - was needed. With

respect to the pictorial warning measure, Thailand reiterated that it would follow the TBT Agreement and notify the measure to the TBT Committee in due course. Thailand also reaffirmed

its full compliance with respect the principles of free trade and its right to protect the health of the Thai population, especially the young generation.

4.4.13 China — Regulations for the Supervision and Administration of Medical Devices (Order No. 650 of the State Council), G/TBT/N/CHN/1022, G/TBT/N/CHN/1023, G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026, G/TBT/N/CHN/1029 (IMS ID 42839)

The representative of the European Union raised concerns regarding the Chinese Regulation

for the Supervision and Administration of Medical Devices. The full statement is contained in G/TBT/W/556.

37 G/TBT/M/74, para. 2.111; G/TBT/M/73, para. 2.82; G/TBT/M/72, para. 3.126; and G/TBT/M/71,

para. 2.141. 38 G/TBT/M/74, para. 2.109. 39 For previous statements follow the thread under IMS ID 428 (under dates raised and references).

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The representative of the Republic of Korea stated that in licensing and registering imported medical devices, China only recognized test reports issued by laboratories located in China. This led to unnecessary duplication of testing and additionally incurred costs and delays. Therefore, Korea respectfully requested China to designate or recognize not only laboratories located in China but also those in foreign countries, or to recognize test reports issued by internationally accredited laboratories in the process of licensing imported medical devices.

The representative of China said detailed explanation had been provided at previous meetings, for most of the questions raised. She added that in January 2018, China Food and Drug Administration (CFDA) had released a guideline to instruct the work on the acceptance of the clinical trials results of medical devices overseas as clinical evaluation materials. This guideline was to reduce the duplication of clinical trials, and speed up the marketing process.

4.4.14 Kingdom of Saudi Arabia, Kingdom of Bahrain, State of Kuwait, Oman, Qatar,

United Arab Emirates, Yemen — The Cooperation Council for the Arab States of the Gulf Draft Technical Regulation for "Requirements of Handling Energy Drinks", G/TBT/N/ARE/262, G/TBT/N/QAT/389, G/TBT/N/SAU/669, G/TBT/N/ARE/299, G/TBT/N/BHR/426, G/TBT/N/KWT/309, G/TBT/N/OMN/238, G/TBT/N/QAT/423, G/TBT/N/SAU/910, G/TBT/N/YEM/29, G/TBT/N/ARE/301, G/TBT/N/BHR/428, G/TBT/N/KWT/311, G/TBT/N/OMN/240, G/TBT/N/QAT/425, G/TBT/N/SAU/912, G/TBT/N/YEM/31 (IMS ID 44240)

The representative of the European Union continued to raise concerns regarding the regulation on the requirements of handling energy drinks and reiterated previously raised concerns.41

The representative of Switzerland reiterated previously raised concerns.42 Switzerland had submitted additional comments in December 2017 and looked forward to receiving replies. He requested that the GCC GSO take all the comments submitted into account.

The representative of the State of Kuwait, on behalf of the GCC, reported that the GCC GSO

was still drafting the regulation based on comments received by Members. Since the last meeting, no updates had been received on this matter.

4.4.15 European Union — Common Criteria for Information Technology Security Evaluation (Common Criteria) certification in the EU (IMS ID 44843)

4.99. The representative of China reiterated previously raised concerns.44

4.100. The representative of the European Union repeated the responses provided at previous

Committee meetings.45

4.4.16 China — Administrative Measure on Cosmetics Labelling (AMCL)

G/TBT/N/CHN/1064 (IMS ID 45646)

The representative of Japan noted that the revision of "Regulations on the Supervision and Administration of Cosmetics" was scheduled to be deliberated in 2018 and requested that China provide a sufficient time-period prior to its entry into force as well as for public comments. She understood that AMCL would be revised in accordance with the revision of "Regulations concerning

Hygiene Supervision over Cosmetics" and requested that China consider Japan's concerns on manufacturer labelling, evaluation of cosmetics efficacy claims, and efficacy assessment testing organization.

40 For previous statements follow the thread under IMS ID 442 (under dates raised and references). 41 G/TBT/M/74, para. 2.117 and statement circulated in full in G/TBT/W/489. 42 G/TBT/M/73, para. 2.88; and G/TBT/M/74, para. 2.118. 43 For previous statements follow the thread under IMS ID 448 (under dates raised and references). 44 G/TBT/M/74, para. 2.120; and G/TBT/M/73, para. 2.85. 45 G/TBT/M/74, para. 2.121 and statement circulated in full in G/TBT/W/490; and G/TBT/M/73, para.

2.86. 46 For previous statements follow the thread under IMS ID 456 (under dates raised and references).

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The representative of the European Union reiterated previously raised concerns47 which were also reflected in what was sent to the Chinese authorities on 12 January 2015.

The representative of Switzerland supported concerns raised regarding this measure.

The representative of New Zealand expressed ongoing interest in the development of the measure and welcomed any updates by China on the timeline for a revised version of the measure for entry into force. She reiterated previously raised concerns48 regarding labelling requirements,

third party verification of test results and timelines and fees for product registration and approval.

The representative of China emphasized that registration fees for drugs and medical devices are common practice internationally. The registration fees in China are calculated on the basis of costs. The difference between the drugs and medical devices only reflects the different workloads and pricing levels.

4.4.17 China — Registration Fees for Drugs and Medical Device Products (IMS ID 46649)

The representatives of the Republic of Korea and Australia reiterated previously raised concerns regarding China's discriminatory registration fees for drugs and medical device products.50

The representative of China repeated the response provided at the previous Committee meeting.51

4.4.18 China — Interim Measures for Quality Management of Commercial Coal (IMS ID 47752)

The representative of Australia thanked China for continuing bilateral discussions on

Chinese coal standard and conformity assessment measures. Australia noted that the implementation and the application of these measures continued to represent great interest for Australian industry and exporters. According to statistics and advice from the Australian coal sector, a direct negative impact of the coal standards on Australian exports of coal to China had been indicated. Australia expressed its support for China's environmental objectives of improving air quality and promoting the efficient and cleaner use of coal. He recalled China's advice from the

previous Committee meeting that both imported and domestic coal had to satisfy the same standards and stated that the requirement to retest coal in China was causing significant delays for Australian exports and greatly adding to trade costs. His delegation noted that Australian testing facilities were equipped to accurately test for quality standards, and that Australian coal was exceeding these high standards. In light of this, Australia continued to maintain that a suitable solution to the problem would be for China to accept coal test results by independent test

laboratories in Australia, in line with other coal-importing countries.

The representative of China recalled the Interim Measures for Quality Management of

Commercial Coal that had entered into force in January 2015. Both imported coal and domestic coal in China were required to meet the same standards set in Interim Measures for Quality Management of Commercial Coal.

4.4.19 India — The Stainless Steel Products (Quality Control) Order, 2015, G/TBT/N/IND/50 (IMS ID 48653)

The representative of the European Union reiterated previously raised concerns on India's Stainless Steel Products (Quality Control) Order, 2015.54

47 G/TBT/M/74, para. 2.123 and statement circulated in full in G/TBT/W/491. 48 G/TBT/M/74, para. 2.124; G/TBT/M/73, para. 2.91; G/TBT/M/72, para. 3.144; and G/TBT/M/71,

para. 2.155. 49 For previous statements follow the thread under IMS ID 466 (under dates raised and references). 50 G/TBT/M/74, paras. 2.126 and 2.127, respectively. 51 G/TBT/M/74, para. 2.128. 52 For previous statements follow the thread under IMS ID 477 (under dates raised and references). 53 For previous statements follow the thread under IMS ID 486 (under dates raised and references).

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The representative of India repeated the responses provided at previous Committee meetings55, and looked forward to discussing any issues bilaterally should clarification be required.

4.4.20 India — Draft Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2015, G/TBT/N/IND/51, G/SPS/N/IND/119 (IMS ID 49456)

The representative of the European Union reiterated previously raised concerns.57 The EU welcomed the publication of the regulation on additives for alcoholic beverages in the Gazette in

August 2017, though not all concerns had been taken on board. The EU noted that the regulation covering standards for alcoholic beverages had been published in April 2018 and would come into force in April 2019. While this regulation answered some of the points raised by the EU, there were still issues of concern.

The EU noted that in order to be fully in line with Article 2.4 of the TBT Agreement, India

should align its draft alcoholic beverages regulations with those international practices and

standards. Issues of concern continued to be (i) lack of stock-exhaustion clause to minimize the impact for economic operators; (ii) lack of acknowledgment of geographical indications; (iii) the presence of some technical specifications (maximum alcohol content, sugar content) not in line with international standards that could prevent some EU wines, spirits or beers entering the Indian market; (iv) over-labelling (residues of additives in the final product) potentially triggering additional technical controls that might result in unjustified barriers to trade; and (v) excessive analytical parameters that would result in additional technical controls (residual extracts, higher

alcohol, iron, etc).

The representative of Japan reiterated previously raised concerns.58

The representative of India recalled the responses provided at previous Committee meetings.59 He noted that after conclusion of the previous meetings, his delegation had passed on written responses to the delegation of EU. On some of the additional queries raised by EU prior to

the last meeting of TBT Committee, relevant information had already been provided on 22 March 2018. Accordingly, India believed that most of the questions raised had been responded to. A

bilateral meeting with the EU had also taken place on the margins of this meeting. In brief, India stated that: (i) A comprehensive set of standards on Alcoholic Beverages namely "Food Safety and Standards (Alcoholic Beverages) Regulations, 2018 had been notified on 28 March 2018. These regulations had been formulated based on existing national standards (BIS) and international standards like OIV keeping in view the prevailing Indian conditions and practices; (ii) The draft regulations had already been notified to the TBT/SPS Committees (G/SPS/N/IND/119 dated 14

December 2015 and G/TBT/N/IND/51 dated 1 December 2015); (iii) Comments submitted by EU had been duly considered and wherever appropriate, suitable amendments had been made to the Regulation. The provisions of Additives were now largely harmonized with OIV standards as requested. Accordingly, standards for additives/enzymes/processing aids for use in category 14.2 (Alcoholic Beverages including alcohol free and low alcoholic counterparts) were prescribed in table 14 of FSS (Food Product Standards and Food Additives) Regulations, 2016 (notified on 5 September 2016). Further provisions of additional additives/processing aids and enzymes for

grapes wine, distilled spirituous beverages and aromatized alcoholic beverages had been notified on 31 July 2017 in FSS (Food Product Standards and Food Additives) Regulations, 2017, and (v) With regard to GI products, all GI products had been omitted from the Food Safety and Standards (Alcoholic Beverages) Regulations, 2018 as the GI products in general were regulated through "Intellectual Property Act" (IPR act) of India. India remained available to meet bilaterally on any remaining or additional issues.

54 G/TBT/M/74, para. 2.136. 55 G/TBT/M/74, para. 2.137; G/TBT/M/73, para. 2.100; G/TBT/M/72, para. 3.158; and G/TBT/M/71,

para. 2.185. 56 For previous statements follow the thread under IMS ID 494 (under dates raised and references). 57 G/TBT/M/74, para. 2.140; and G/TBT/W/495. 58 G/TBT/M/74, para. 2.141. 59 G/TBT/M/74, para. 2.142; G/TBT/M/73, para. 2.123; G/TBT/M/72, para. 3.163; and G/TBT/M/71,

para. 2.197.

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4.4.21 Indonesia — Halal Product Assurance Law No. 33 of 2014 (IMS ID 50260)

The representative of the European Union continued to have serious concerns with regard to the Indonesian Halal Product Guarantee Law No 33. The full statement is contained in G/TBT/W/557.

The representative of the United States said that the US recognized the importance for Indonesian consumers to know whether products were halal, and wanted to work with Indonesia

to ensure that the law would be implemented to achieve the objective without creating any unnecessary barriers to trade. As Indonesia had finalized a draft implementing regulation on Halal Product Assurance that would be signed and issued soon, she requested that this draft regulation be notified to the TBT Committee prior to finalization to allow for comments from stakeholders and to allow time for those comments to be considered. She also requested that Indonesia provide sufficient transition time for stakeholders to provide feedback on, understand, and comply with

requirements.

She asked that Indonesia confirm that the most recent version of the draft implementing regulation would allow for phased implementation of the Halal Law's mandatory halal certification requirements, and that Indonesia would continue to allow the sale of non-certified products. Concerns remained with any mandatory requirement that both "halal" and "non-halal" products be labelled. The US supported providing consumers with the necessary information to make informed decisions. However, mandating labels for both halal and non-halal information would create

confusion for consumers and would be costly and challenging for companies, both foreign and domestic, to implement.

The registration requirement for foreign halal certificates included in the draft regulation appeared to be cumbersome, duplicative, and more trade restrictive than necessary to achieve the objectives and did not seem to apply to local products. She requested Indonesia to modify this registration requirement to reflect the fact that Indonesia's Halal Product Assurance Agency

("BPJPH") would already be conducting verification of foreign halal agencies issuing halal

certificates for imported goods.

The representative of Brazil supported the concerns raised by the EU and the US. There were many doubts concerning the process of implementation of this law. He requested Indonesia to provide an update on recent developments on its internal discussions and that any draft technical regulation be notified to the TBT Committee.

The representative of Australia reiterated previously raised concerns.61 Indonesia's Halal

Product Assurance Law No.33 of 2014 was due to take effect from 1 November 2019 and Australia noted the importance of publication of the regulatory changes sufficiently in advance to ensure that businesses had time to prepare for and adjust to the changes. Australia welcomed Indonesia's response in the previous TBT Committee meeting that Indonesia was developing implementing regulations. Australia recognized the importance of halal product assurance to many Indonesian consumers and wanted to work cooperatively with Indonesia through ongoing and early

engagement on developments with the halal law and its implementing regulations. Australia also

sought clarification that "halal" and "non–halal" labelling requirements would be voluntary rather than mandatory, which would ensure the requirements were not more trade restrictive than necessary.

The representative of Indonesia informed that the related government institutions were still discussing the implementation stage regarding the product scope which included both food and beverage products and non-food and beverage products. On the labelling of halal products, it was not necessary to put a "non-halal" label for products containing non-halal substances. It was

sufficient to provide non-halal information in the form of pictures, mark or statements so as to ensure the protection and human rights of vulnerable groups, particularly disabled people. Indonesia would ensure that the regulation would be in line with the TBT Agreement.

60 For previous statements follow the thread under IMS ID 502 (under dates raised and references). 61 G/TBT/M/74, para. 2.145.

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4.4.22 China — Formula Registration Regulation for Infant and Follow-up Formula, G/TBT/N/CHN/1165 (IMS ID 49362)

The representative of the European Union, whilst sharing China's objective of ensuring the highest level of protection in the area of infant and follow-up formula, continued to raise concerns on some aspects of the new regulatory regime. His delegation considered that the limitation of each manufacturing company to a maximum of nine registered recipes within three product lines

would have a significant negative impact on EU exports to China. The EU did not find a justification for this limitation, neither on the basis of food safety nor on the basis of other legitimate objectives. He also noted that the foreseen one-year transition period was not sufficient considering that significant changes were required and once again proposed an 18-month transition period. China was asked to take these comments into account and modify the implementing rules accordingly.

The representative of the United States supported the EU's intervention and thanked the China Food and Drug Administration (CFDA) for providing additional information on Decree 26 over the past year, and for showing flexibility with regard to implementation dates for registration of infant formula and other "special foods". However, a number of issues still required clarification, and her delegation hoped that China could work with the US and other Members to avoid any trade disruptions.

The representative of China said that the purpose of on-site inspection was to check the

R&D data of formula and the production capacity, which was different from any other inspection. In this regard, competent authorities had strengthened coordination and cooperation to avoid duplication of inspections. Domestic and foreign enterprises would be treated equally. Meanwhile, she reported, a reasonable transitional period had been given to prevent an unnecessary negative impact on international trade. Regarding registration, China on the one hand carried out review and approval works strictly following the rules, and on the other hand made efforts to secure smooth transition and stable supplies in the market. As of 8 June 2017, the CFDA had approved

1,156 formula in 151 enterprises, comprising 876 formula in 104 domestic enterprises and 280 formula in 47 overseas enterprises. Members were invited to refer to CFDA's website.

4.4.23 Russian Federation – Rules of cement certification, G/TBT/N/RUS/48, G/TBT/N/RUS/49 (IMS ID 49763)

The representative of the European Union reiterated previously raised concerns64 regarding the Russian Federation's rules for cement certification. The full statement is contained in

G/TBT/W/558.

The representative of Ukraine reiterated its previously raised concerns65 regarding the Russian Federation's certification requirements for cement. Access to the Russian Federation market for cement depended on meeting conformity assessment requirements established in the Eurasian Economic Union (EAEU), meaning that the applicant needed to have an entity or agent on the territory of the EAEU and the business relationship needed to be demonstrated via a written

contract with the foreign producer, which was also required to be registered pursuant to the

legislation of the EAEU member state. He noted that these mandatory registration requirements for applicants created additional burdens on other WTO Members' producers as compared to those in the EAEU, which might contravene Article 5 of the TBT Agreement. Ukraine also took note of the EU's concerns and requests contained in their statement from the previous Committee meeting.66 Ukraine expected a much greater willingness from the Russian Federation to provide the information requested by WTO Members, which represented fundamental WTO transparency commitments necessary for predictable and non-discriminatory international trade. Ukraine invited

the Russian Federation to engage in a positive manner and restore conditions which would enable renewed trade in cement.

62 For previous statements follow the thread under IMS ID 493 (under dates raised and references). 63 For previous statements follow the thread under IMS ID 497 (under dates raised and references). 64 G/TBT/M/74, para. 2.153 and statement circulated in full in G/TBT/W/498; and G/TBT/M/73, para.

2.110. 65 G/TBT/M/74, para. 2.152; and G/TBT/M/73, para. 2.111. 66 G/TBT/W/498.

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The representative of Mexico continued to raise concerns regarding the rules of cement certification, specifically the conformity assessment procedure GOST P 56836 2016. She noted that despite the various statements made by Mexico and by other countries in the Committee, industry had notified that to date there had been no changes regarding the conformity assessment procedures, which discriminated against importers of cement. Imported cement continued to be classified as a product posing an environmental risk, which meant that cement imports were

stopped at Russian customs to undergo an inspection, which could last up to one month, leading to losses and creating additional costs. In addition, few certification authorities issued the required certificates and the majority of such authorities did not work with importing enterprises, which clearly made it complicated to obtain a certificate and to comply with the requirement. For Mexico in particular, the measure implemented by Russia had led to the liquidation of the company branch in Russia as it had become impossible to sustain business due to the significant losses experienced

in the previous two years. She pointed out that the measure implemented by Russia could infringe Articles 5.1.1, 5.1.2 and 5.2.1 of the TBT Agreement as applying a conformity assessment

procedure to imported cement had discriminatory and trade restrictive effects and resulted in higher costs for importers of the product. In this context, Mexico requested Russia to take into consideration the comments made by Members affected by the measure and propose a revision of the measure to improve the application of the conformity assessment procedure for shipments of cement from third countries that were destined for countries in the EAEU.

The representative of the Russian Federation recalled statements made during previous Committee meetings67 and indicated that the draft amendments to the certification requirements were expected to be adopted by the end of the summer.

4.4.24 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 50568)

The representative of the European Union reiterated previously raised concerns regarding

the implementation of the Egyptian decrees.69 In addition, in relation to the transparency of the process, she asked whether the Egyptian authorities could confirm that a list of registered companies was publicly available, and to indicate where such a list could be found.

The representative of Switzerland reiterated previously raised concerns.70

The representative of Canada thanked Egypt for the productive bilateral meeting they had held at the margins of the meeting and expressed her delegation's hope that it would lead to a

better understanding of Egypt's registration requirements.

The representative of Thailand expressed his delegation's interest in Egypt's system. Thai exporters were currently in the pending process for final approval by Egypt authorities, despite applications in 2016. He encouraged Egypt to facilitate the registration process in a transparent and timely manner to avoid any trade disruption.

The representative of Egypt said that Decrees 991/2015 and 43/2016 had different scopes, as the first related to pre-inspection, while the second was an administrative measure aiming at

protection against trade deceptive practices. Decree 991/2015 did not introduce any new measures as it was simply an update to the executive regulation to Law 118/1975 on Import and Export. Decree 43/2016 was not technical in nature and it included no obligation to comply with any technical requirements, neither did it require the application of a specific quality control system. Decree 43/2016 covered only a limited number of tariff lines whose exports had invaded the Egyptian market despite the fact that they represented a minimal share of Egypt's imports, merely due to illegal manufacturing practices that were seriously jeopardizing the health and

safety of Egyptian consumers. The registration process according to Decree 43/2016 did not require any complicated procedures as all the documents required were ones that any credible company should hold; and, furthermore, no renewal of the registration was required as long as the

67 G/TBT/M/74, para. 2.155; G/TBT/M/73, para. 2.113; and G/TBT/M/72, para. 3.181. 68 For previous statements follow the thread under IMS ID 505 (under dates raised and references). 69 G/TBT/M/74, para. 2.156 and statement circulated in full in G/TBT/W/499. 70 G/TBT/M/74, para. 2.158; G/TBT/M/73, para. 2.144; and G/TBT/M/72, para. 3.184.

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documents presented were valid. Decree 43/2016 was also in full compliance with the national treatment principle, as Egyptian manufacturing plants were equally subject to registration, surveillance, and inspection requirements by numerous Egyptian regulatory authorities to ensure their compliance with relevant standards and regulations. Decree 43/2016 was also not more trade restrictive than necessary, and, in this respect, it was worth mentioning that despite the initial decrease in the value of Egypt's imports after the entry into force of the decree, Egypt's imports

had witnessed a significant increase in 2017.

She also underscored that the Egyptian government was constantly reviewing its trade-related measures and regulations to ensure the facilitation of trade flow with trade partners. Egypt was therefore grateful for all the comments raised on this topic during this meeting or during bilateral meetings held with interested Members.

4.4.25 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 51971)

The representative of the United States recalled that her delegation had previously expressed appreciation for the efforts Kenya and other EAC countries had made to engage with WTO Members on their draft regional East African Community (EAC) alcohol standards.72 Like others, the United States continued to be interested in hearing from Kenya about the status of

those draft standards. At the Committee's last meeting, Kenya had indicated that the regulatory review process at the EAC level had been completed. Could Kenya provide an update about whether the standards had already been agreed by the EAC?

The representative of the European Union supported the EAC members in their efforts to ensure the quality standards of alcoholic beverages consumed in their territories. The EU invited Uganda and Kenya to further update the Committee on the status of the revision and on how other

comments presented by other WTO Members were being taken into account in the standard's

revision process. Also, in relation to the process of revision, the EU encouraged EAC members to keep ensuring that foreign stakeholders had an opportunity to present views on the revision process. Could Kenya and Uganda 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. Also, the EU recalled that the minimum time for

the entry into force of new technical regulations should be at least six months; EAC members were encouraged to provide an even longer transition period to allow companies to adapt to the new requirements.

The representative of Argentina shared the concerns expressed by other Members and said Argentina was closely followed the development of the relevant standards.

The representative of the Kenya responded to the concerns. The full statement is

contained in G/TBT/W/544.

4.4.26 European Union — Quality Schemes for Agricultural Products and Foodstuffs, G/TBT/N/EU/139, G/TBT/N/EU/139/Add.1 (IMS ID 51273)

The representative of Uruguay raised concerns with the Quality Schemes for Agricultural Products and Foodstuffs. The full statement is contained in G/TBT/W/543.

The representative of the United States reiterated concerns raised in the previous meeting.74 The registration of the name "danbo" disregarded, without justification, the existing Codex standard and the US failed to see why the EU was not recognizing the existence of an

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

references). 72 G/TBT/M/74, para. 2.162. 73 For previous statements follow the thread under IMS ID 512 (under dates raised and references). 74 G/TBT/M/74, paras. 2.164-2.166.

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applicable international standard. The US felt the application under consideration for havarti also lacked transparency and once again asked the EU for a status update. She reaffirmed opposition to the EU granting GI protection for havarti as there was an international Codex Alimentarius standard of identity for havarti, which Codex members – including the EU – had reconfirmed in 2007, 2008 and 2010.

The representative of the European Union repeated the response provided in the previous

TBT Committee meeting contained in G/TBT/W/501.

The representative of Uruguay regretted that the EU had not responded to its request to engage in dialogue. He informed the Committee that Uruguay would request that this matter be included in the agenda of the next meeting of the Council for Trade in Goods, scheduled to take place on 3 July 2018.

The representative of the United States said that this was a TBT matter. The EU had

correctly notified its quality schemes regulation under the TBT Agreement precisely because of the TBT elements such as labelling requirements.

4.4.27 The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu – Draft of the Organic Agriculture Act, G/TBT/N/TPKM/225, G/TBT/N/TPKM/225/Add.1-2 (IMS ID 51175)

The representative of the European Union thanked Chinese Taipei for written communication and bilateral dialogue on the proposed regulation on organic products, noting that

the new bill had been published on 30 May 2018. His delegation understood that Chinese Taipei would enact a series of implementing measures before the bill's enforcement in May 2019. The bill contained a two-year transition period after which the unilateral recognition of 16 member States would expire. He reiterated the EU's concern that the two-year period would be too short to conclude an MRA due to lengthy internal technical and political procedures, including the adoption

of a negotiation authorization and the ratification by the EU co-legislators. The EU considered that the measure would disproportionately affect trade partners and suggested that a more flexible

transitional arrangement be considered in the future. His delegation was also concerned how the new provisions would be implemented. Therefore, the EU asked Chinese Taipei to be closely involved before the new implementing laws were adopted, notably regarding how the system of control bodies would be set up and implemented.

The EU further requested that Chinese Taipei effectively apply the unilateral equivalency of standards for EU products, which it believed to not be the case since, in practice, compliance with

Chinese Taipei standards still seemed to be checked. In addition, Chinese Taipei was requested to find a way to extend the unilateral recognition to all 28 member States, recalling that the EU was a single market with single production standards. As such, unequal treatment by Chinese Taipei was therefore not justified.

The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu appreciated the EU's continued concern on the Organic Agriculture Promotion Act, previously notified as the Organic Agriculture Act. He explained that the act had been promulgated

on 30 May 2018 and would enter into effect one year later, on 30 May 2019. Implementing measures would soon be proposed which would bridge current practices and those specified in the Act. Relevant draft measures on certification and management of organic agricultural products and processed products would be notified for comments once available.

He stated that the Act marked a very important milestone in the history of agricultural development. The draft text had been notified to the WTO in October 2015 and an impressive number of comments had been received from domestic and foreign stakeholders as well as

hundreds of discussions held to better address identified needs. The adopted text provided for a comprehensive system which would not only drive the efforts towards friendly, eco-balanced and sustainable agriculture, but would also enhance the competitiveness of organic agricultural products. However, the act would require subsequent renegotiations of equivalence agreements

75 For previous statements follow the thread under IMS ID 511 (under dates raised and references).

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concluded previously. Taking into account the EU's request to extend the transition period, he recalled that one extra year had been added for the renegotiation process.

Concerning the requirements applying to organic products, Chinese Taipei clarified that, in the absence of international standards, Members usually maintained their own requirements to accommodate different organic environments they intended to preserve and such requirements were also respected in equivalence arrangements. Chinese Taipei viewed equivalence acceptance

as a process towards harmonization and welcomed any opportunity to further exploring this issue bilaterally. He also acknowledged the necessary time to seek the ratification of an equivalence arrangement in the EU and as an alternative recalled Article 17 of the act which invited certification bodies to be accredited to certify products for exports to Chinese Taipei. Chinese Taipei stated its willingness to provide further information to facilitate the application process.

4.4.28 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 50976)

The representative of the European Union reiterated previously raised concerns77 about China's mandatory National Standards on Limits of Volatile Organic Compounds for Furniture.

The representative of China noted that the three notifications in question had been submitted in July 2015.78 In 2016, in accordance with the six measures from "Deepening the Reform Program of Standardization Work", China had simplified and integrated all mandatory

standards, including those related to the furniture industry. Furthermore, according to the relevant requirements of "Notification of completing the follow-up work for the conclusion of the simplifying and integrating of mandatory standards" (Document no. 464 of the Department of Science and Technology, Ministry of Industry and Information Technology in 2017), the integration and development work of standards was ongoing. China added that due to the reform of the State Council in March 2018, the relevant standards had not yet been introduced. Foreign parties were

welcome to consult with China on the technical issues of the standard. The relevant contact person

was Luo Jufen, the Secretary General of the National Technical Committee for the standardization of furniture.

4.4.29 Ireland — Public Health (Alcohol) Bill 2015, G/TBT/N/IRL/2 (IMS ID 51679)

The representative of Mexico reiterated previously raised concerns on this measure.80 These concerns were on labelling requirements – the inclusion of health warnings with no scientific basis; the setting of minimum prices; advertising restrictions; the physical separation of products

at points of sale; and restrictions on sales promotion techniques.

The representative of the United States reiterated previously raised concerns.81 The US remained concerned that Ireland had not yet notified the amendments to the TBT Committee, thus denying Members the opportunity to submit comments. The US asked if Ireland would accept

products that had been labelled for other EU markets or would producers have to relabel any product that first entered another EU member State that they subsequently wished to send to Ireland for sale.

The representative of Argentina reiterated concerns regarding Ireland's Public Health (Alcohol) Bill 2015. The full statement is contained in G/TBT/W/551.

The representative of Guatemala stated his delegation's systematic concern with this measure. At the previous meeting of the Committee, the EU had said that the European Commission had until 2 May to issue an assessment of the measure. He asked that this

76 For previous statements follow the thread under IMS ID 509 (under dates raised and references). 77 G/TBT/M/74, para. 2.171 and statement circulated in full in G/TBT/W/503. 78 G/TBT/N/CHN/1094, G/TBT/N/CHN/1095 and G/TBT/N/CHN/1096. 79 For previous statements follow the thread under IMS ID 516 (under dates raised and references). 80 G/TBT/M/74, para. 2.187; and G/TBT/M/73, para. 2.165. 81 G/TBT/M/74, para. 2.190.

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information be shared and whether the internal process within the EU was being followed and what was the date of entry into force of the measure.

The representative of New Zealand reiterated previously raised concerns.82

The representative of Australia recognized the right of governments to take measures necessary to protect public health and Ireland's efforts to address a legitimate public health concern. Australia sought clarification as to the evidence on which this draft legislation and

labelling requirements were based, including how the proposed measures would contribute to public health objectives. Australia also sought clarification on the details and implementation of the new requirements, in particular the recent amendments regarding labelling. Clarification of the impact of the requirements on importers and exporters was also requested. Australian exporters were concerned about the impact of the labelling requirements on their business, in particular the cost involved in developing bespoke labels for the Irish market. Noting that significant

amendments had been made to the Bill since it was last notified to the WTO, Australia encouraged Ireland to re-notify the new Bill through the TBT notification procedure, to allow trading partners to comment on the revised proposal. Australia requested advice on the expected timing for implementation of the new requirements, and urged Ireland to consider a transition period to enable businesses time to prepare for the new requirements.

The representative of Chile supported the comments made by other delegations. Chile had reviewed the labelling requirements and requested further information on the outcome of the

studies undertaken.

The representative of the European Union reiterated previously raised concerns.83 Comments received through the internal notification procedure had been analysed by the Irish authorities and replied to on 12 March 2018. Some of the labelling provisions (health warnings) had been notified under another notification procedure laid down by Regulation (EU) 1169/2011 on food information to consumers. The Commission was not in a position to provide comments

without having more detailed information in relation to the modalities of the labelling provisions in

question, including the wording of the notified health warnings. Ireland had been invited to notify the relevant draft regulation once the modalities were defined. On 19 January 2018 Ireland had notified three amendments to the draft "Public Health (Alcohol) Bill 2015". These amendments had been assessed by the European Commission and the member States in accordance with both the above-mentioned internal procedures. Ireland had received comments from the Commission and detailed opinions and comments from some EU member States. These reactions were currently

being analysed by the Irish authorities. Ireland would duly notify WTO Members about these amendments and provide a period for Members to comment on them. As regards comments received from WTO Members under the WTO TBT notification procedure, these would be equally examined and written replies would be provided in due course.

4.4.30 Kazakhstan, Russian Federation — The amendments No. 2 to the Technical Regulation of the Customs Union on Safety of Toys (TÐ ÌÑ 008/2011), G/TBT/N/KAZ/7, G/TBT/N/RUS/73 (IMS ID 51484)

4.160. The representative of the European Union reiterated previously raised concerns regarding the amendments to the Safety Toy EAEU Technical Regulation.85 In addition, he recalled that during the March 2018 Committee meeting, the representative of Kazakhstan had stated that draft amendments were still being discussed by the working group. It was added that no developments had occurred since March 2017, the authorities were analysing the ISO standard on age determination, and that positive consideration was being given to this alternative. The EU understood that a meeting of the Working Group was scheduled for 18 June 2018. The meeting

was to discuss amendments to the technical regulation regarding the introduction of psychological and pedagogical examination of toys at the EAEU level. The EU asked for an update about the process related to the draft amendments both at EAEU and national level in Kazakhstan and Russia. In particular, the EU requested an update about the activities of the working group. What

82 G/TBT/M/74, para. 2.192. 83 G/TBT/M/74, para. 2.167. 84 For previous statements follow the thread under IMS ID 514 (under dates raised and references). 85 G/TBT/M/74, para. 2.178 and statement circulated in full in G/TBT/W/505.

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was the outcome of the meeting of 18 June 2018? Had the possibility of replacing the proposed criteria by age grading requirements based on ISO 8124 been discussed?

4.161. The representative of Ukraine reiterated previously raised concerns.86

4.162. The representative of the United States supported the intervention of the EU and Ukraine.

The representative of Canada echoed the concerns raised by other WTO Members and looked forward to updates regarding possible revisions to the draft amendments, including with

respect to the consideration of ISO standards for age-grading.

4.164. The representative of Kazakhstan confirmed that a discussion of the Working Group had focused on how to strike a balance between the protection of children's interest and the interests of producers and importers. Also, as stated at the last meeting, there was a positive consideration

on implementation of ISO standards in Kazakhstan. The Working Group had been created for the purpose of adaptation of the standards into the domestic legal framework. In addition to that,

preparatory work had been held in order to ensure effective implementation of the ISO standard. For example, sales of toys in open air markets would be prohibited. With respect to Ukraine's comment, she explained that certification of conformity of toys had always been applied in Kazakhstan, even before adoption of custom union of technical regulation on safety of toys. Kazakhstan authorities had never registered any problems with obtaining conformity certificates for products originating from Ukraine. She noted, in this respect, that the TBT Agreement did not preclude a Member from choosing a type of conformity assessment scheme which it considered

appropriate in ensuring its legitimate objective. She also directed Members to Kazakhstan statements in previous meetings.

The representative of the Russian Federation lent his delegation's support to Kazakhstan's efforts aimed at protecting children's health. Within the EAEU, a special Working Group had been established to review the draft amendments, as well as all the comments received according to the

procedure of drafting, adoption, modification and cancellation of the EAEU technical regulations. The Working Group was looking for a balance between children health protection and trade effects

of the measure. His delegation took note of the concerns raised by the interested Members and would relay them to the Working Group.

4.4.31 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 52087)

The representative of the European Union welcomed and acknowledged the efforts of the Russian authorities regarding the common rules in the field of medical devices and recalled that his

delegation had submitted comments on the drafts on 15 June 2016. The EU asked Russia whether the special working group of the Eurasian Economic Commission ensured that registration procedures were the same for foreign and domestic importers of goods and whether it reviewed its position confirming that 300 days was a normal period for expert evaluations. In relation to

G/TBT/N/RUS/51, he reminded that the timeline for expert evaluations in the EU was normally between 30 and 60 days. The EU believed that the long review time established in the draft measure would not allow the market to keep up with the pace of innovation. As regards

G/TBT/N/RUS/53, the EU understood that all the relevant information regarding safety and efficiency for medical devices had to be put on the label of that medical device. The EU asked Russia whether the announced consultations with the Ministry of Health on labelling requirements had taken place and what their outcome had been.

The representative of Ukraine reiterated its concerns and supported those raised by other Members in the previous five Committee meetings. Russia had not yet provided a response to the questions regarding certification requirements which placed additional burdens on those exporting

to Russia compared with domestic producers. Ukraine requested that Russia be more willing to provide basic information in line with WTO transparency commitments so as to ensure predictable and non-discriminatory trade.

86 G/TBT/M/74, para. 2.177; and G/TBT/M/73, para. 2.169. 87 For previous statements follow the thread under IMS ID 520 (under dates raised and references).

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The representative of the Russian Federation informed the Committee that concerning the establishment of the single market of pharmaceutical products in the EAEU through the relevant treaties, all the necessary acts had entered into force on 6 May 2017. He added that their entry into force did not mean significant changes in the existing system of registration. Currently, producers and importers had an opportunity to register medical devices in the national system of registration or in the system of the EAEU. Registration certificates issued in the Russian

registration system would be valid only on the territory of the Russian Federation. Registration certificates issued in accordance with the rules of the EAEU would operate on the territory of all countries of the EAEU. This transition period would last until 31 December 2021. In 2022, the Russian registration system would be replaced by the EAEU system. However, previously issued registration certificates would be valid until 31 December 2025. During this transitional period, a special working group of the Eurasian Economic Commission would continue to work with the aim

of considering all comments from stakeholders. He clarified that the timeline for the expert evaluation normally lasted 100 days, but that the manufacturer (or applicant) had an opportunity

to suspend the expert evaluation. In such cases of suspension, the maximum period of evaluation could not exceed 330 days.

4.4.32 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 52188)

The representative of the European Union reiterated previously raised concerns89 regarding measures which the Russian Federation had adopted introducing certification requirements for medicinal products, both for human and animal use.

The representative of the Russian Federation said that the situation with regards to the

implementation of the Agreement on Common Principles and Rules of Pharmaceutical Products Circulation was similar to that of the Agreement on Common Principles and Rules of Medical Devices Circulation (see IMS ID 520). All requirements and conformity assessment procedures were identical for domestic and imported pharmaceutical products. He underlined that the Russian Good Manufacturing Practice (GMP) inspection system fully complied with international standards and recommendations. The State Institute of Pharmaceutical Products and Good Practice was the

body authorized to conduct GMP inspections. As an illustration of its capacities, during the period from 1 January 2016 to 30 October 2017, the institute had conducted 738 inspections of manufacturers (626 foreign and 112 domestic) for compliance with GMP rules. The number of inspections of foreign manufacturers was 188 in 2016 and 438 for the first 10 months of 2017. Statistics showed that the number of inspections of foreign manufacturers was almost six times the number of domestic ones. In addition, the number of inspections of foreign manufacturers in 2017 was almost 2.5 times the number in 2017. The approved GMP inspection schedule for

producers of imports was published on the website of the Ministry of Industry and Trade and included more than 300 inspections from February to August 2018. Finally, he noted that the step-

by-step registration procedure of applying for GMP certification, waiting for the inspection, obtaining a certificate and in the end registering the medicine had been slowly streamlined. The draft amendments to the Federal Law "On the Circulation of Medicines" (№ 61-FZ) had been adopted by the Federal Law № 140-FZ and had entered into force on 15 June 2018. The amendments allowed the possibility to provide a copy of the GMP certificate or a copy of the

decision of the Ministry of Industry and Trade to initiate the medicine registration process. In addition, it was not a requirement anymore to provide a GMP certificate and repeat the inspection in case of changes in the medicine's quality and/or in the methods of its control. The changes were designed to simplify and speed up the registration of new medicines in the Russian market. Russia had taken note of the concerns raised by the EU and was ready to continue to work with the EU on this matter.

88 For previous statements follow the thread under IMS ID 521 (under dates raised and references). 89 G/TBT/M//74, para. 2.185 and statement circulated in full in G/TBT/W/507.

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4.4.33 China — Cybersecurity Law (IMS ID 52690)

The representative of the United States referred the Committee to the concerns raised at the previous meeting.91 There had been no new developments in the meantime.

The representative of Japan reiterated previously raised concerns.92 Japan requested that China provide a clear definition of the terms "secure and controllable" or "secure and trustworthy", as they had not yet done so.

The representative of the European Union reiterated concerns raised in the previous TBT Committee meeting. The full statement is containing in G/TBT/W/509.

The representative of the Republic of Korea reiterated previously raised concerns.93

The representative of Australia reiterated previously raised concerns.94 Australia appreciated China's April 2018 public consultation on its draft Provisions on Internet Security Supervision and Inspection. He highlighted the importance of benchmarking new business

regulations against international best practices and working in consultation with the foreign business community. Australia was concerned the draft provisions could require Australian businesses to disclose trade secrets or intellectual property. Such requirements would run counter to China's repeated statements about improving the business environment for foreign companies in China. He asked that China advise how it would protect intellectual property as it implements internet security and supervision regulations.

The representative of China repeated the response provided at the previous Committee

meeting.95

4.4.34 European Union — Organic production and labelling - Maté (erva-mate) (IMS ID 52496)

The representative of Brazil welcomed the entry into force of EU Regulation 2018/848 on 17 June, which included yerba mate in the European list of organic products and thanked the EU for addressing its requests on this matter. However, the regulation would entry into force only on 1 January 2021, renewing the concerns of producers. Brazilian exports of yerba mate to the

European market had not enjoyed a seal that could legitimately be attributed to their production for purely historical reasons. The previous law (EC 834/2007) was based on Annex I of the Treaty establishing the European Communities (the Treaty of Rome) in order to define the list of organic products and, at the time, there had been no concerns with maté. The fact that it was not possible for yerba mate to receive the organic seal had been damaging the exports of Brazilian producers to the European market for years, mainly small producers, which invested their scarce resources

towards the recognition of their sustainable way of production. In order to prevent Brazilian exporters from continuing to suffer for the next two and a half years, Brazil asked for a transitional solution so that mate producers could benefit from the organic seal before 2021.

The representative of the European Union repeated the response provided at the previous Committee meeting97, as well as bilaterally, and recalled that the new Regulation, which included mate in its scope, would enter into force on 1 January 2021.

90 For previous statements follow the thread under IMS ID 526 (under dates raised and references). 91 G/TBT/M/74, para. 2.195. 92 G/TBT/M/74, para. 2.196. 93 G/TBT/M/73, para. 2.189; and G/TBT/M/74, para. 2.198. 94 G/TBT/M/73, para. 2.192. 95 G/TBT/M/74, para. 2.201. 96 For previous statements follow the thread under IMS ID 524 (under dates raised and references). 97 G/TBT/M/74, para. 2.213 and statement circulated in full in G/TBT/W/512

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4.4.35 China — Cyberspace Administration of China – Draft implementing measures for the Cybersecurity Review of Network Products and Services (IMS ID 53398)

The representative of Japan reiterated previously raised concerns.99 Although China had provided explanations on these measures at previous meetings, there was still a lack of clarity as to the articles regulating the terms definitions, the concrete requirement for review and the evaluation, and the scope of regulation. Japan was concerned that the measures may hamper

market access of foreign companies to China or cause leakage of confidential technology, depending on concrete details of rules or their implementation. Therefore, Japan requested China to implement this measure in a non-discriminatory manner in line with TBT Agreement. Japan also requested China to clarify the terms definitions, the concrete contents of requirements and the scope of regulation as well as to ensure transparency and that the relevant regulations and procedures were consistent with international standards and practices. Finally, Japan requested

China to implement the regulation transparently and in full consideration of the views held by

Japan and other Members.

The representatives of the United States, the European Union and the Republic of Korea reiterated previously expressed concerns100 on this measure. Korea requested China to clarify the scope and procedure of the 'cooperation' of network security evaluation foreseen under Article 12.

The representative of China reiterated the response provided at the previous TBT Committee meeting.101

4.4.36 China — Draft revised Encryption Law of the People's Republic of China by the Office of State Commercial Cryptography Administration (OSCCA) (IMS ID 534102)

The representative of the European Union reiterated previously raised concerns. The full statement is available in G/TBT/W/514.

The representative of Japan reiterated previously raised concerns.103 She asked if China was, as had been stated, actively researching and adopting the relevant suggestions from all parties while working on further revisions of the draft.

The representatives of the Republic of Korea and the United States reiterated previously raised concerns.104

The representative of China repeated its response provided at the previous Committee meeting. 105 He assured the Committee that the revision of the Draft would fully reflect the spirit of the administrative reform and transforming government functions, and take WTO rules and globally accepted practices into full consideration.

4.4.37 European Union — Regulation (EC) No 1107/2009 - non-renewal of approval of the active substance picoxystrobin G/TBT/N/EU/437 (IMS ID 535106)

The representative of Brazil reiterated previously raised concerns107 and noted that the EU position was not in line with technical and scientific negative findings on the genotoxicity of picoxystrobin, such as those from the US Environmental Protection Agency (EPA) and the CODEX Committee on Pesticides Residues (CCPR), which had recently approved picoxystrobin maximum residue levels (MRL) for various raw materials. In addition, Brazil recalled previous scientific

consensus on the matter, some of which emanated from European authorities. The Council

98 For previous statements follow the thread under IMS ID 533 (under dates raised and references). 99 G/TBT/M/74, para. 2.127. 100 G/TBT/M/74, paras. 2.214-2.216; and G/TBT/M/73, paras. 2.221-2.224. 101 G/TBT/M/74 para. 2.217. 102 For previous statements follow the thread under IMS ID 534 (under dates raised and references). 103 G/TBT/M/74, para. 2.218; and G/TBT/M/73, para. 2.216. 104 G/TBT/M/74, paras. 2.220-2.221; and G/TBT/M/73, paras. 2.217-2.218. 105 G/TBT/M/74, para. 2.222; and G/TBT/M/73, para. 2.220. 106 For previous statements follow the thread under IMS ID 535 (under dates raised and references). 107 G/TBT/M/74, para. 2.223.

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Directive 91/414/EEC had declared picoxystrobin to be non-toxic and the recommendations of the FAO WHO Joint Meeting on Pesticides Residues (JMPR) had concluded that the substance was not genotoxic. In addition, nearly 70 countries had already approved the use of the substance, including the USA, China, Canada and Japan among others. Furthermore, European authorities such as the Standing Committee on Plants Animals, Food and Feed and the Appeals Committee had not reached a conclusive decision on this issue ("no opinion") and the report of the European

Food Safety Authority had highlighted that "it was not possible to conclude on the genotoxicity potential of picoxystrobin based on the available data". Finally, there were the findings of the EU's Rapporteur Member State, the Czech Republic. In this context, Brazil requested the EU to take into consideration that the possible reduction of maximum residue levels (MRL) for the substance could have serious consequences for Brazil's trade in agricultural commodities, such as soy and coffee. Therefore, Brazil asked for its concerns to be taken into account, in compliance with Articles 2.2

and 2.5 of TBT Agreement. Brazil also requested the EU to take into consideration the standards being discussed in CODEX, in order to avoid the creation of unnecessary restrictions to trade and,

finally, to declare picoxystrobin as safe for the protection of crops and renew the licensing of products treated with this substance."

The representative of Canada reiterated previously raised concerns108 and requested clarity around the status of existing MRLs to manage imports.

The representative of the European Union, recalling the detailed explanation provided at

the previous TBT Committee, said that the European Commission had decided not to renew the approval of picoxystrobin through Commission Implementing Regulation (EU) 2017/1455. Authorisations for plant protection products containing picoxystrobin in the EU were required to be withdrawn by 30 November 2017 while Member States were permitted to allow for a grace period until 30 November 2018 at the latest. The EU had notified third countries of the draft Regulation via the WTO TBT transparency procedures. The measure had not lead to immediate disruptions in trade, as the measure itself did not amend the maximum residue levels (MRLs) and provided for a

grace period for use of products containing picoxystrobin. Given the issues identified by the

European Food Safety Agency (EFSA), the existing MRLs would likely be reviewed in a separate measure in view of their safety to consumers. Import tolerance requests would however remain possible and would be assessed case by case by EFSA. While the Commission had entered into discussions with EU Member States regarding possible changes in the MRLs for picoxystrobin, a concrete draft measure had not yet been prepared. When such a draft was available, the EU would

notify it under the WTO SPS agreement and consult its trading partners before submitting it for vote to the Standing Committee on Plants, Animals, Food and Feed.

4.4.38 European Union — Titanium dioxide: Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 (IMS ID 539109)

The representative of the United States recalled that over the years, her delegation had raised transparency concerns regarding the EU's process to develop regulations and standards for the registration and use of chemicals, both as substances and in products. The EU's WTO

notifications tended to come only after its own scientific and regulatory committees had completed

their years-long reviews, raising transparency concerns regarding the consideration of international stakeholder input at an early and appropriate stage in the development of a regulation. Further, she explained that for highly complex products, such as chemicals, where the science of assessing hazards and risks was quickly evolving and scientific studies could take years, this was a missed opportunity to meaningfully integrate international participation and comments, which her delegation believed brought the consultative intent of the EU's notifications into

question. She said that as a result, EU's regulatory decisions might overlook the best available science and not align with other countries' chemical classifications, which could lead to potential trade barriers that could hinder innovation and unnecessarily disrupt trade.

She said that the EU's recent decision to classify Titanium Dioxide (TiO2), a white mineral-based pigment used in products ranging from paints to sunscreens, as causing cancer when inhaled, illustrated these transparency concerns. TiO2 was widely acknowledged as a safe additive,

supported by extensive studies on consumer and industrial use. As TiO2 could irritate the lungs via

108 G/TBT/M/74 paras. 2.226-2.227; G/TBT/M/73 para. 2.213; and G/TBT/M/72 para. 3.19. 109 For previous statements follow the thread under IMS ID 539 (under dates raised and references).

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extensive industrial exposure, decades-standing practice was for workers to wear protective gear against inhalation, including in the EU. The US believed the EU to be overturning current international standards for classifying chemicals by labelling TiO2 as cancerous. The decision was controversial both among EU member States and overseas, and it was unclear whether the classification would result in better protection for consumers and workers. It would, however, create confusion in the $20 billion global TiO2 industry and the $80 billion in downstream

industries using TiO2 in their products, due to costly, new cancer labelling requirements. The US therefore asked that the EU delay this classification to allow time for meaningful stakeholder consultation on TiO2 and recalled its offer to consult with experts from the US government and industry.

The representative of the European Union explained that TiO2 had been included in the 2018 Adaptation to Technical and Scientific Progress (ATP) amending the CLP Regulation. Several

discussions on the classification of TiO2 and the classification of mixtures containing TiO2 had

taken place in the expert group for REACH and CLP ("CARACAL"), in November 2017 and March 2018. At the request of and based on the comments received from member States and stakeholders, the Commission had organised a dedicated discussion on TiO2 on 23 April 2018, which a US delegate had attended. Following that meeting and considering other comments and input received, the Commission Services had proposed a wording for the inclusion of TiO2 in Annex VI to CLP. The proposal had been presented to and discussed in the CARACAL meeting of 12 June,

as well as in the REACH Committee meeting of 13 June. The Commission's proposal was to limit the entry in Annex VI to the respirable (powder) form of TiO2. In addition, many notes would be included indicating that mixtures containing TiO2 only need to be classified if placed on the market in powder form.

Participants to both meetings had been invited to provide their comments and based on these, the entry and notes might be further refined. It was foreseen to take the vote on the ATP to CLP (containing the TiO2 entry) in September 2018. The EU reassured the Committee that any

proposal to classify TiO2 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 Members would be duly considered by the Commission in the decision-making process for the formal adoption of a RAC opinion. Finally, the EU stressed that ECHA's RAC committee had considered in its scientific assessment all available data, including the information submitted during the public consultation period. Review of a RAC opinion was only

possible if new scientific information was available.

4.4.39 China — Catalogue of Solid Wastes Forbidden to Import into China, G/TBT/N/CHN/1211, G/TBT/N/CHN/1224, G/TBT/N/CHN/1225, G/TBT/N/CHN/1226, G/TBT/N/CHN/1227, G/TBT/N/CHN/1228, G/TBT/N/CHN/1229, G/TBT/N/CHN/1230, G/TBT/N/CHN/1231, G/TBT/N/CHN/1232, G/TBT/N/CHN/1233, G/TBT/N/CHN/1234 (IMD ID 545110)

The representative of New Zealand reiterated previously raised concerns.111

The representative of the United States reiterated previously raised concerns112 on the negative trade and environmental impacts resulting from China's import ban and accompanying measures further restricting imports of recovered materials. She noted that although China had invoked the legitimate objective of environmental protection, no details had been provided on the specific environmental concerns the country was hoping to address, nor how the restrictive measures were expected to improve these concerns. Moreover, China's current approach appeared to be having the opposite effect. She said that the most likely outcome was that the ban on post-

consumer plastics and restriction of trade in post-industrial plastics would redirect reusable plastics from productive purposes, such as recycling, to the waste stream.

While the US recognized and appreciated China's interest in addressing valid environmental concerns, regret was expressed that requests had been refused to meet with experts from China's Ministry of Environmental Protection to understand the environmental

110 For previous statements follow the thread under IMS ID 545 (under dates raised and references). 111 G/TBT/M/74, paras. 2.236-2.237. 112 G/TBT/M/74, paras. 2.233-2.234; and G/TBT/M/73, paras. 2.8-2.9.

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concerns, the necessity of the measures, and to work cooperatively to ensure that valid environmental concerns were met in the least trade-restrictive manner possible. Instead, China had moved forward with the implementation of those highly trade-restrictive measures and moreover had recently expanded the scope of restricted materials. On 19 April, several ministries had issued a notice adding 32 types of scrap and waste to the Catalogue of Prohibited Import Solid Waste.

The US requested that China immediately suspend implementation of its import ban and import control standards for recovered materials and urged China to break its silence if it really hoped to address valid environmental concerns. China was also asked, at least in the interim, to revise the measures in line with existing international standards for trade in recycled commodities. Further, China was requested to observe the 60-day comment period consistent with the Committee recommendations and to subsequently grant a reasonable implementation timeframe.

She recalled that China's notifications G/TBT/N/CHN/1211, G/TBT/N/CHN/1212, and

G/TBT/N/CHN/1224 through G/TBT/N/CHN/1234 had entered into force well before the customary six-month minimum timeframe for technical measures.

Finally, her delegation noted that for a vast number of materials outlined in both the ban and import control standards, China appeared to have no mandatory commensurate domestic standard in place. For example, for the 21 categories of non-ferrous metal commodities subject to China's import control standard notified in G/TBT/N/CHN/1228, China appeared to have only

voluntary standards for just three categories of non-ferrous metal: copper, aluminium, and zinc, and no domestic standards, voluntary or otherwise, for the remaining non-ferrous materials specified in the measure. The US remained concerned that a ban and related import control standards with such a broad scope may be more trade restrictive than necessary to fulfil the stated objectives, and that there appeared to be fundamental differences between requirements for foreign and domestic commodities.

The representative of Canada thanked China for the response to its written comments on

the set of measures contained in notifications G/TBT/N/CHN/1224 through G/TBT/N/CHN/1234. Though it outlined some of China's objectives, Canada continued to have questions and concerns over the restrictive standards on imports of recyclable materials. Canada reiterated its comments provided at the previous TBT Committee meeting.113 His delegation again highlighted that the trade in recyclable materials between Canada and China was mutually beneficial. Chinese manufacturers had a long history of obtaining valuable raw materials from Canada, which were

now being impeded by uncertainty related to China's standards. Canada therefore sought a more precise definition of what was supposed to be considered "carried waste" for each standard as well as a precise explanation of the testing procedures performed by Chinese inspectors upon entry into China. While recognizing its goal of limiting harmful environmental impacts, Canada encouraged China to consider all possible mechanisms to ensure that trade could continue in a predictable manner.

Concerning the import ban notified in G/TBT/N/CHN/1211, Canada continued to share

concerns over the uncertainty that China's restrictions on the import of solid waste was creating

for traders and reiterated its comments provided at the previous TBT Committee meeting.114 Canada also recalled China's Ministry of Ecology and Environment announcing its plan to ban the import of more scrap and waste products by the end of 2019. Canada encouraged China to notify those additional measures to the TBT Committee as soon as possible to provide other Members time to comment on them and to take those comments into account.

The representative of Australia appreciated China's efforts to reduce pollution through a

broad range of measures but nevertheless echoed the concerns of other Members. He noted that the measures were already having a significant impact on Australian exporters and the environment, with scrap materials potentially being sent to landfill, instead of being recycled in China and recovered for intermediate materials. Australia remained concerned that the measures were more trade restrictive than necessary to achieve the desired objectives and supported other Members in finding the timeframe for comments to be insufficient. Australia urged China to

withdraw the measures, and to consider all possible mechanisms to meet its environmental

113 G/TBT/M/74, paras. 2.15-2.16. 114 G/TBT/M/74, paras. 2.238-2.239.

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objectives and reduce hazardous waste, while not disrupting valuable trade in recyclable materials.115

The representative of the European Union supported the statements and concerns made by New Zealand, the US, Canada and Australia.

The representative of China responded to the concerns raised. The full statement is contained in G/TBT/W/546.

4.4.40 India — Amended regulation on toy imports, G/TBT/N/IND/68 (IMS ID 546116)

The representative of the European Union expressed concern that the notified measure required toys imported into India to be tested by a test laboratory accredited by National Accreditation Board and Calibration Laboratories (NABL), India. His delegation considered this

obligation for third-party testing to be costly and time-consuming, especially for producers in exporting countries who were obliged to duplicate testing with very limited or no added value in

terms of safety. He stated that the notified measure replaced the earlier requirement according to which imported toys had to conform to international standards (such as ISO 8124) and testing had to be done by laboratories accredited under ILAC MRA. The EU continued to urge India to explain the rationale for this change in policy, and to consider allowing conformance to the relevant international standards as an alternative to the BIS standards. The EU asked India whether it could confirm that the amended regulation allowed NABL accreditation to be granted to international laboratories, i.e. laboratories not located in India.

Regarding implementation, his delegation was concerned that difficulties and delays faced by international laboratories in getting accredited by NABL could lead to the amended regulation corresponding to de facto in-country testing. India was asked to clarify whether international labs had applied and whether accreditation requests were being processed expeditiously. Clarification was also requested on the issue of the validity period of test reports as uncertainty on this issue

was likely to create additional problems to foreign producers. The EU stated that a test report should not had limited validity if there had been no change to the material or the production

process or in standards, and that test reports should remain valid for a minimum of 36 months. He noted that it had transmitted written questions and concerns to India, as requested at the previous Committee meeting, and looked forward responses and clarifications to be provided in the Committee, or bilaterally.

The representative of the United States supported India's goal of ensuring toy safety but had serious concerns with the burdensome nature of the amendment, which harmed the US toy

industry's ability to access the Indian market. The US was surprised by the extent to which the measure unfairly targeted imported toys. She recalled that prior to regulatory changes, India employed what many considered the "gold standard" of toy regulatory regimes, meaning that toy manufacturers could test to either the ASTM, ISO, or EN toy safety standards in the country of manufacture by a lab accredited under the ILAC system.

India had noted that the measure had been put into place immediately due to issues concerning safety of children, yet despite numerous requests India had not provided important

information regarding the evaluation of specific toy hazards. The US therefore requested detailed information on the safety concerns of imported toys that had led to the new standard and in-country testing requirements. It was her delegation's understanding that India might be replacing the existing measure with a new regulation that would apply to all toy producers, both domestic and foreign. He requested that India notify the new regulation and allow interested parties to comment. She further recalled that in 2016 the US had been the seventh largest exporter of toys to India, primarily specialty toys from small and medium sized manufacturers. The US was also

home to two of the world's largest toy companies, for which the value of the Indian toy market was estimated at $75-100 million for 2016. As such, the US viewed the measure's potential effect on trade to be of deep concern.

115 G/TBT/M/74, para. 2.235. 116 For previous statements follow the thread under IMS ID 546 (under dates raised and references).

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The representative of China supported India's efforts to ensure toy safety but remained concerned that the amended regulation required the imported toy to be in conformity only with Indian standards, rather than international, EU or US standards which had been accepted in the past. China also noted that the new regulation required that the imported toys be tested by NABL, instead of labs accredited under ILAC MRA which had already caused higher costs to toy enterprises in China. He hoped India could modify its present toy imports regulations, to allow for

toys to be in compliance with international, EU or US standards, and tested by ILAC MRA labs for imports. Additionally, China hoped India would notify the measure, and provide comment and transitional period for any future amended regulations, to enable companies to adjust their production and adapt to new requirements.

The representative of Canada supported the concerns raised by other Members and referred to its statement in previous meetings.117

The representative of India explained that the measure had been imposed through DGFT notification No. 26 dated 1 September 2017 revising the import policy for toys and notified to the TBT Committee in G/TBT/N/IND/68 dated 7 December 2017. As previously stated, the measure had been put in place to immediately stop the imports of toys posing health hazards to users, particularly children and had been based on analysis and inputs received from stakeholders. He said that it had been found that toys being imported into India were unsafe for children from a health angle and hence, as an emergency measure, action had been taken to ensure appropriate

standards and correct conformity assessment. Detailed information on safety concerns on toys had already been highlighted in the referred standards i.e., IS 9873 and IS 15644.

India informed the Committee that the regulation was equally applicable domestically, and therefore not discriminatory. He said that the number of NABL-accredited labs was sufficient and that there was no delay in testing. Moreover, test costs were lower than international rates. He also confirmed that there were no foreign labs outside India which were accredited by NABL for toys under this regulation. Applications had been received and were in process by the relevant

authority. Concerning the validity of testing, reports were given for a particular consignment or lot.

4.4.41 China — Certification requirements for processed foods, G/TBT/N/CHN/1209 (IMS ID 547118)

The representative of the United States thanked China for its bilateral engagement to date on the concerns raised on the proposed official certification requirements for imported foods and also for its September 2017 announcement notifying WTO Members of the two-year transitional

period for enforcement from 1 October 2017 until 30 September 2019. The US also welcomed the clarifications provided by China thus far, and understand China was considering further changes and clarifications to the measure in the coming months. The US asked China to confirm that it intended to notify a revised measure to the WTO and to provide an estimate of when that notification may be transmitted. The US, however, remained concerned about the potential trade implications of this measure. The broad scope of products affected was of particular concern. The proposed measure also appeared to include processed, shelf-stable foods that ordinarily posed

little to no risk for food-borne illnesses. The types of concerns addressed by this measure were not commensurate with the enormous administrative burden and increased cost that it would impose on manufacturers, exporters, importers and ultimately consumers. The US also believed that China's proposed requirements appeared to deviate significantly from the extensive array of relevant Codex guidelines and principles which Members were obliged to take into account when developing official certification requirements, absent a risk assessment appropriate to the circumstances. The US welcomed the opportunity to work with China to assess the requirements of

the proposed measure consistent with legitimate food safety and health protection goals, and to present a manageable information exchange consistent with those objectives to support fair trade in food products.

The representative of the European Union reiterated previously raised concerns.119 The EU also supported the statement made by the US.

117 G/TBT/M/73, para. 2.22; and G/TBT/M/74, para. 2.246. 118 For previous statements follow the thread under IMS ID 547 (under dates raised and references).

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The representative of the Republic of Korea shared the concerns raised by the US and the EU and requested China not to unnecessarily expand the scope of this regulation. He also asked China to share and notify a revised draft of the regulation in a transparent manner.

The representative of Japan shared concerns raised by the US, the EU and Korea and recognized that China was in the process of taking into account comments received at various occasions and was considering the new measure. Japan requested China to provide timely updates

and appropriately include responses to the comments provided.

The representative of Switzerland stated that his delegation's main concern was that the measure applied to all processed foods and did not apply a risk-based approach. Switzerland therefore encouraged China to structure its certification requirement for processed foods in accordance with established international standards. Switzerland welcomed the decision by China to postpone the date of enforcement to 1 October 2019. By doing so, China had shown its

willingness to adjust the measure to make it more effective, practical and to minimize its negative effects on trade. The measure was scheduled to enter into force in approximately 15 months from the date of this meeting. In order not to forego this opportunity, China should engage with Switzerland and other Members and use the time for further discussions. As a first step towards this goal, China could provide responses to questions and comments submitted by Switzerland and other Members.

The representative of Guatemala thanked China for its willingness to amend the entry into

force of this measure to October 2019 giving industry necessary time to adapt to the new measures. However, she also requested that China respond in writing to her delegation's comments submitted in August 2017, with information on the current state-of-play of the measure, in particular concerning the situation of processed low-risk non-perishable products. She also asked China to inform when it expected the final version of the regulation would be made available prior to entry into force as well as the restructuring of the measures.

The representative of China stated that, in order to ensure the safety of imported food and

improve the traceability system thereof, the former General Administration of Quality Supervision, Inspection and Quarantine had formulated the Administration Measures for Certificate Accompanied with Imported Food, notified to WTO in June 2017. The measures required exporters to provide certificates accompanied with the food exported to China, certifying that the pro-duction, processing, storage, transportation, and export process of relevant products were under supervision, so as to ensure the safety and the complete traceability information of the relevant

products. Whilst exporters had different supervision systems, the procedures for issuing certificates needed coordination and arrangement of several institutions. In September 2017, China decided to postpone the implementation date by two years to 1 October 2019. After the notification, interested parties responded actively and provided comments. China was willing to consider all the reasonable comments and adjust this measure to make it more effective and practical. In March 2018, the First Meeting of the Thirteenth National People's Congress reviewed and approved the Institutional Reform Plan of the State Council, and, as a result, the management

responsibility of entry-exit inspection and quarantine of General Administration of Quality

Supervision, Inspection and Quarantine (AQSIQ) was assigned to the General Administration of Customs (GACC). This reform would be in place by the end of 2018. At present, the relevant departments from former AQSIQ were studying the integration plan with the departments of General Administration of Customs. China welcomed Members' comments and suggestions.

4.4.42 Viet Nam — Decree on the regulation on conditions for automobiles manufacturing, assembling importing and automotive warranty & maintenance services,

G/TBT/N/VNM/116 (IMS ID 549120)

The representative of Thailand recognized the efforts of Vietnam to protect legitimate objectives of human health, safety and environment. However, Thailand's automobile industry faced difficulties and obstacles in exporting cars to Vietnam due to the application of the Decree 116, which was inconsistent with the TBT obligations. Thailand deemed that the regulation was applied in a non-transparent, trade-restrictive and discriminatory manner.

119 G/TBT/M/74, para. 2.249 and statement circulated in full in G/TBT/W/518. 120 For previous statements follow the thread under IMS ID 549 (under dates raised and references).

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He noted that the retroactive notification of Decree 116 had not allowed any time for comments by Members. The short gap between the publication and the entry into force of Decree 116 was not a reasonable interval of time for the automotive industry since car importers typically needed several months of lead time prior to importation. Therefore, Thailand urged Vietnam to delay the implementation of the Decree 116 to allow time for producers in exporting countries to adapt their products to Vietnamese requirements.

He added that Decree 116 required Vehicle Type Approval (VTA) certificates and emission, quality and safety inspection for every single lot of imported cars. This was inconsistent with international practice and significantly time-consuming and costly. He reminded that according to the TBT Agreement, conformity assessment procedures should be undertaken and completed as expeditiously as possible. The requirement to test by lot was clearly not expeditious since Vietnam had only one emission testing laboratory and it took up to two months to undertake all the test

and inspection and customs clearance for only one import shipment. The documentation

requirement was not limited to what was necessary to assess conformity and not clearly prescribed in the regulation. These requirements were applied more strictly than necessary to give Vietnam adequate confidence that products conformed to the applicable regulations and therefore created unnecessary obstacles to international trade.

Additionally, Thailand stated that cars of Vietnamese origin were treated more favourably than those originating in other countries, resulting in discriminatory treatments to exports. This

was the case because results of automobile checking and certificates were valid for 36 months for cars of Vietnamese origin, whereas imported cars were subject to lot-by-lot inspection. Thailand requested Vietnam to suspend the requirements for inspection and testing of each shipment. Thailand hoped that Vietnam would take into consideration its concerns and fulfil its obligations under the TBT Agreement, eliminating unnecessary obstacles to international trade.

The representative of Japan reiterated previously expressed concerns121 on this measure. Since the entry into force of Decree 116 on 1 January 2018, the automobile industry had faced

challenges with meeting requirements. Japan requested Viet Nam to consider industry's comments and to revise the Decree immediately.

The representative of the European Union thanked Vietnam for providing the opportunity to discuss G/TBT/N/VNM/116 and reiterated previously expressed concerns.122 The EU noted that it had sent comments to Viet Nam on 12 April 2018, however Vietnam's answer received on 31 May did not sufficiently address the issues raised by the EU. In particular, the EU's concern about the

discrimination of imported vehicles in relation to domestically produced ones, stemming from Article 6 of the Decree, had not been addressed. Since the answers provided by Vietnam to EU comments did not address EU's concerns, the EU invited Vietnam to reassess the EU comments, and to provide relevant replies, in line with the spirit of the TBT Agreement. The EU called upon Vietnam to consider all the comments made by the EU and the other WTO Members and to modify the Decree accordingly.

The representative of the United States remained extremely concerned with the provisions

contained in Decree 116, in particular, the VTA certificate and lot-by-lot testing requirements. The United States requested again that Vietnam notify the implementing circular for Decree 116, Circular 3 (Circular No. 3/2018/TT- BGTVT), to the WTO TBT Committee, as committed at the March 2018 TBT Committee meeting. This was important since Circular 3 laid out conformity assessment procedures, including mandatory certification requirements.

The representative of Canada thanked Vietnam for the bilateral meeting held earlier in the week. Canada continued to have concerns with Vietnam's requirements, echoed the comments of

other WTO Members, and looked forward to receiving Viet Nam's response to its questions.

The representative of the Russian Federation joined interested delegations in expressing concern regarding Decree 116/2017. The Russian Federation requested Viet Nam to suspend the application of the Decree and to allow sufficient time for comments by Members.

121 G/TBT/M/74, para. 2.254. 122 G/TBT/M/74, para. 2.256.

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The representative of Viet Nam thanked Canada for the bilateral meeting. Viet Nam noted that the objective of Decree 116 was to protect customer safety and the environment. Decree 116 had been promulgated and implemented on the basis of non-discrimination between domestic and foreign car manufacturers. Viet Nam explained that the VTA requirement was mandatory not only for imported cars but also for all cars produced or assembled domestically. Viet Nam informed the Committee that the Viet Nam Register under the Ministry of Transport had accepted 119

applications for import registration with total 56 different motor vehicle types, and had granted technical and environment safety certificates for 26 vehicle types, with 4,385 cars placed on the market. Up to June 2018, some manufacturers from US, Korea, Thailand and several developed Members had successfully imported vehicles into Viet Nam. The lot-by-lot testing and inspection for imported cars was one of the appropriate measures to ensure the quality consistency which had been being applied by many countries in parallel with vehicle type approval. Viet Nam took

note of all comments and said it would provide further responses.

4.4.43 Viet Nam — Cybersecurity Measures (IMS ID 544123)

The representative of Japan expressed its concern and strong interest and recognized that Viet Nam had revised the draft law, but that the revised draft law still included various provisions which could hinder participation of foreign companies in the Vietnamese market. He said his delegation was aware that the Vietnamese government would provide the details of the "cybersecurity condition" under the draft law. At the previous meeting, Japan had requested Viet

Nam to clarify its requirement and procedures and not to hinder participation of foreign companies in the Vietnamese market, to which Viet Nam had replied that Members' comments would be conveyed to the relevant authorities for responses. Japan recognized that the Viet Nam National Assembly had passed the Cybersecurity Law on 12 June and enquired whether other Members' concerns had been taken into account in the final draft. Japan requested Viet Nam to consider the comments from Japan and other Members, and to implement the law in a transparent manner to avoid it being more trade-restrictive than necessary.

The representative of the United States expressed deep concern with the draft law and disappointment that Viet Nam had failed to notify it formally to the WTO with a comment period while still in draft form. Viet Nam was therefore urged to immediately notify the law and any draft implementing measures and to work with US and other stakeholders to resolve concerns with the law. Her delegation encouraged Viet Nam to consider a risk-based approach to cybersecurity drawing from industry best practices, widely accepted definitions, and international standards. Viet

Nam was also requested to consider the Common Criteria Recognition Arrangement (CCRA) certification process when preparing implementing measures for the law.

The representative of Canada supported the comments of other delegations and continued to follow the measure with interest.

The representative of the European Union said that her delegation shared Members' concerns with the potential of the Vietnamese draft Cybersecurity law to create unnecessary barriers to trade. She noted that according to the latest available information, the law had been

adopted by the Vietnamese National Assembly on 12 June 2018 and asked Viet Nam to confirm this and to provide any additional information on the following steps regarding the law as well as any plans for the development of implementing measures, in particular concerning cybersecurity verification. She reiterated the statement made by her delegation in the previous meeting concerning the need for Viet Nam to notify this measure under Article 2.9 of the TBT Agreement.124

The representative of Viet Nam thanked delegations for their comments and confirmed

that the draft Cybersecurity law had been adopted by Viet Nam National Assembly on 12 June 2018. She stressed that the legitimate objective of this measure was to protect national security. Furthermore, the requirement of cybersecurity conditions under this measure applied to important information system of national security, which mainly belonged to governmental agencies. She said that her delegation had taken note of all the comments and concerns raised by Members, and would duly relay them to relevant authorities for further consideration and response.

123 For previous statements follow the thread under IMS ID 544 (under dates raised and references). 124 G/TBT/M/74, para. 2.262 and statement circulated in full in G/TBT/W/520.

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4.4.44 European Union — The establishment and operation of a traceability system for tobacco products, G/TBT/N/EU/505, G/TBT/N/EU/507 (IMS ID 550125)

The representative of Cuba reiterated previously raised concerns regarding the establishment and operation of a traceability system for tobacco products. The full statement is contained in G/TBT/W/545.

The representative of the European Union recalled their statement made in the previous

TBT Committee meeting.126 She noted that the adoption of these acts was preceded by a detailed consultation process, during which relevant stakeholders from the EU and third countries had been invited to share their views. This included notification of the draft acts under WTO TBT procedures and detailed analysis of all comments received from third countries, including Cuba. Justified comments had been considered and replies had been issued to the countries concerned. She confirmed that the situation of third countries, as well as the potential impact that the new

systems may have on them, had been borne in mind throughout the preparation process. She also recalled that the obligation to ensure overall compliance with the provisions of the legislation fell on the importer of the products into the EU.

4.4.45 European Union — Amendments to the Directive 2009/28/EC, Renewable Energy Directive (IMS ID 553127)

The representative of Malaysia continued to raise concerns over the proposed amendments to the European Union's Renewable Energy Directive. The full statement is contained in

G/TBT/W/548.

The representative of Indonesia informed the Committee that during a recent bilateral meeting further clarification had been sought on the amendments of the EU Renewable Energy Directive (RED II) jointly agreed by the European Parliament, the Council of Europe and the European Commission on 14 June 2018. Indonesia thanked the EU for the clarification provided on

16 June 2018 entitled "Palm oil, Outcome of the Trilogue EU's Renewable Energy Directive RED II Factsheet" ("EU clarification"). Indonesia requested further clarification on several issues.

Regarding the initial proposal to ban palm oil and phase out palm oil in biofuel mix by 2030, would the ban still apply to palm oil? He also asked the EU to clarify the categories concerned by the agreement reached which included gradual reduction of the amount of certain categories of biofuel counted towards the EU's renewable energy target. If the categories included palm oil, did it also apply to rapeseed oil? Indonesia requested that the RED II proposal be notified to the WTO and allow 60 days for comment.

Given the negative perception of palm oil in the EU, Indonesia believed that the EU would refuse biofuels produced from raw materials obtained from land with biodiversity such as primary forests regardless of the outcome of the future study. He requested the EU to provide the list of vegetable oils that presently were considered as high risk and low risk in the context of indirect use chains. Under the study mandated by the European Commission, how did the EU intend to weight Indirect Land Use Change (ILUC) in developed countries in relation to, for example, palm

oil in developing countries? Indonesia strongly believed that any weighting should consider the

2030 SDGs and the commitment towards achieving these goals. Indonesia also sought clarification on whether the EU would agree that in both developed and developing countries different vegetable oils should not be treated differently, and whether the ILUC study would be adapted to the SDGs. He stressed the importance of addressing environmental concerns at the level of vegetable oils to include, for example, the contamination of soils and oceans from nitrates in both developed and developing countries. Although the EU had explained that the gradual phasing out of palm oil within the biofuel targets would not affect palm oil exports, it would cause significant

adverse impacts on the palm oil sales in the EU. Therefore, the measure would advantageously position European vegetable oils, in particular rapeseed oil. Was the intention of such a ban, in whole or in part, to give preference to domestically produced rapeseed oil? While recognizing that the protection of the environment was a legitimate objective under the TBT Agreement, did the EU

125 For previous statements follow the thread under IMS ID 550 (under dates raised and references). 126 G/TBT/M/74, para. 2.265, and statement circulated in full in G/TBT/W/521. 127 For previous statements follow the thread under IMS ID 553 (under dates raised and references).

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consider that the only environmental challenge in the vegetable oil sector was vegetation and ILUC? Indonesia looked forward to discussing this matter further with the EU.

The representative of Colombia reiterated previously raised concerns.128 According to news in the local press, "the contribution from biofuels and bioliquids produced from palm oil shall be 0% from 2030"; in other words, it expressly stated that biofuels produced from palm oil would not count towards the target for road and rail transport from 2030 onwards. This created a clear

disincentive for transport operators to use biofuels produced from palm oil, since they could not report this as consumption of energy from renewable sources. It would therefore be more difficult for EU countries to achieve the minimum levels for consumption of energy from renewable sources. Colombia requested the EU to increase the transparency related to "Trilogue" talks and provide official information about the agreement reached on 14 June as soon as possible.

The representative of Guatemala supported the concerns raised by other Members. Her

delegation considered that the Tripartite decision on renewable energy would affect trade and have a negative impact on palm oil. Guatemala understood that while the measure did not prohibit the use of palm oil, it discouraged its use and thereby discriminated against palm oil compared to other vegetable oils, in particular oils produced in the EU.

According to Fairhurst and Harder, 0.26 hectares of land was required to produce one metric tonne of palm oil while 0.75 hectares was required for the same amount of rapeseed oil. The measure constituted a barrier to trade and discrimination which would have significant

implications for rural development. In 2017, palm oil was among the top six exports of Guatemala. The new measure would affect bilateral trade, as the EU was one of the top export destinations for palm oil exports. The palm oil agro-industry was a source of direct employment in Guatemala and generated some 28,000 jobs, in particular in rural areas. Moreover, 85,000 families benefited from palm oil production. Guatemala was recognized as the most productive country per hectare. These achievements stemmed from the commitment that Guatemalan producers had made to sustainability and good agricultural practices, which had enabled them to increase their efficiency

per hectare. Furthermore, Guatemala believed that a geographical distinction was necessary for palm oil production and its production conditions. Generalizations could condemn global production. Guatemala was committed to meeting the SDGs and its support for sustainable palm oil certification to meeting the Millennium Goals. In light of the above, Guatemala requested open-ended participation in the discussions on this matter in Brussels so as to prevent implementation of discriminatory measures.

The representative of Honduras echoed the concerns raised by other delegations. While recognizing the legitimate right of WTO Members to adopt environmental protection policies, such measures should be in line with the WTO Agreements and should not create unnecessary restrictions to trade. Phasing out palm oil based biofuels by 2030 would negatively affect the economy as palm oil was an extremely important part of the agri-industry and generated thousands of permanent jobs and supported small farmers. Honduras oil palm plantation was controlled so as to properly protect tropical forests. They had recorded significant growth in this

area with minimal environmental impact. Like Malaysia, Honduras requested further information

on the outcome of the trilogue negotiations. Honduras called on the EU to notify those measures to the TBT Committee.

The representative of Ecuador referred to a press release released by the European Parliament saying it had exerted pressure to reach an agreement to include a complete removal of palm oil by 2030 and freeze imports at their 2017 levels. Ecuador asked for a global assessment of how it would be implemented in practice and how it would lead to a 2023 review. The Directive

would significantly impact palm oil producing countries exporting to the EU. The EU proposal to gradually reduce first-generation biofuels including palm oil based biofuels did not take into account the production specificities of African palms of each country. Ecuador was a sustainable producer of African palms with strict governmental oversight to ensure that Ecuador was committed to environmental and social responsibility. Ecuador noted that the EU Directive lacked any technical and scientific rationale. The representative requested the EU to provide clarification

on the scope and content of the proposed amendment, the time-frame for changes and whether there was still an opportunity to take into account comments before the adoption was finalized.

128 G/TBT/M/74, para. 2.33 and statement circulated in full in G/TBT/W/465.

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

amendment.

The representative of Thailand registered its interest in the matter which it would follow closely. The adoption of the Directive would needlessly lead to the reduction of palm oil biofuel production in future. Thailand would welcome any positive statement from the EU on this matter.

The representative of the European Union said the revision of the Renewable Energy Directive had been discussed in a number of recent expert bilateral meetings. He informed the

Committee that the co-legislators, the Council and the European Parliament, had agreed to gradually reduce the amount of certain categories of biofuels towards the EU renewable energy targets earlier in June. However, this did not constitute a ban or a restriction on the imports on palm oil or palm oil-based biofuels to the EU, but aimed to regulate the extent to which certain biofuels could be accounted towards the EU Renewable Energy targets. The text did not single out palm oil or any other specific biofuel or feedstock. He added that there was still further work that needed to be finalized at technical level. The agreement also foresaw that the Commission would

develop rules to implement those provisions based on the latest and best available solid scientific information. The EU expressed its availability to discuss the issue through appropriate bilateral channels.

4.4.46 European Union — Application of Regulation No. 1169/2011 and Regulation (EC) No. 1924/2006 as regards the labelling of food products, in not prohibiting or examining the use of "palm oil free" labels (IMS ID 555129)

The representative of Colombia reiterated previously raised concerns.130

The representative of Indonesia expressed concern that as the major crude palm oil (CPO) producer exporting products to the EU, the use of "palm oil free" labelling by several EU food product companies led to consumer confusion and misunderstanding on the impact of food products containing palm oil. His delegation believed that allowing food exporters to apply this labelling in the absence of scientific evidence created unfair trade and therefore encouraged the EU to be consistent with EU regulation 1169 Chapter 5 article 36.2 which stated that voluntary

labelling should not mislead and be ambiguous for consumers, and where necessary should be provided with scientific evidence. Based on EU regulation No. 1924/2006 on nutrition and health claims made on foods, the EU did not authorize food to be produced with palm oil containing carotene due to insufficient scientific evidence, in contradiction with the current situation whereby the EU was allowing food producers to use "palm oil free" labelling without scientific justification.

Indonesia emphasised that worldwide research related to the content of palm oil existed,

the results of which could be taken into consideration as scientific justification for the positive side

of palm oil. This included: (i) palm oil contained saturated fatty acids and unsaturated fatty acids at a balanced level; (ii) palm oil was not associated with an increased risk of cardiovascular disease; (iii) palm oil contained microelements of antioxidants benefitting health (carotene, vitamin e, and sterols; and (iv) palm oil had a quality advantage as an oil for frying compared to other vegetable oils, associated with free fatty acids.

In view of the above, his delegation encouraged the EU to be consistent in conducting surveillance especially labelling that was not based on scientific evidence and might mislead

consumers. The EU was also encouraged to consider the principle of non-discrimination on the treatment given to palm oil compared to other vegetable oils such as sunflower, soybean and rapeseed oil. It was therefore deemed important to provide scientific evidence related to the impact of palm oil in food products on human health compared to other vegetable oils. Indonesia also urged the EU to be consistent with Article 2.1 of the TBT Agreement on discrimination and

129 For previous statements follow the thread under IMS ID 555 (under dates raised and references). 130 G/TBT/M/74, para. 2.40 and statement circulated in full in G/TBT/W/467.

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Article 3.4 on measures by local governments and NGOs that should be in line with WTO Agreements.

The representative of Ecuador expressed the view that "palm oil free" labelling of food products was a negative campaign against a specific product without any scientific or technical basis. She stated that it created unfair competition and that it misled the consumer; further it was not based on scientific studies and did not take into account the specificities and positive

nutritional content of palm oil.

The representative of Malaysia expressed support for the concerns of other Members and would monitor developments in the Committee.

The representative of Guatemala shared the concerns expressed by others. She noted that these measures and campaigns identified palm oil as a product that damaged health and

destroyed the environment. "Palm oil free" and "No palm oil" labels had a negative impact and

discouraged the consumption only of palm oil and not of other oils, which constituted discrimination. In addition, this type of labelling misinformed consumers and constituted a form of deceptive advertising. Furthermore, she added that it was unclear how the analyses had been conducted and methodologies formulated for authorizing the display of nutritional properties on labelling. The measures took no account of the efforts made by the Guatemalan palm oil agro industry to ensure that production was sustainable and in conformity with international environmental sustainability standards; or of the ways in which production differed between the

various palm oil producing regions and countries. Guatemala endorsed the questions posed by Colombia and asked the EU for clarification in response to the comments made in this Committee.

The representative of Honduras shared the concerns raised by others and requested more information on the questions that had been raised.

The representative of Costa Rica also shared the concerns raised by others. His delegation

was particularly concerned that the quantity of products in the EU containing the label "free of palm oil" was worrying. This kind of labelling was unfounded as it did not have any scientific basis;

it also aimed to convince consumers that products that were free of palm oil were preferable to those that included palm oil. Costa Rica reiterated that there was no scientific justification to generalize the idea that palm oil products were harmful to health and there was no basis for the EU to accept "free of palm oil" labels on products.

The representative of Thailand shared the concerns raised by others and encouraged the EU to provide further scientific justification on the matter.

The representative of the European Union repeated the response provided at the previous Committee meeting.131

4.4.47 China — Chinese environmental protection control standards for imported solid

waste as raw materials (IMS ID 551132)

The representative of Australia expressed appreciation for China's efforts to reduce pollution and pursue sustainable development through a broad range of measures in the economy, but remained concerned that the Chinese standards were already having a significant impact on

Australian exporters. Australia did not have the waste management infrastructure or recovered materials markets to be able to process and recover a range of waste products exported to China. This had led to concerns that a large amount of waste would go to landfill, instead of being recycled in China and recovered for intermediate materials. Australia noted other Members' comments that many of the contaminant levels appeared different to domestic regulations within China. Australia requested further information about the technical and scientific analysis underpinning the standards and whether domestic Chinese standards would be aligned with those

for imports.

131 G/TBT/M/74, para. 2.46 and statement circulated in full in G/TBT/W/476. 132 For previous statements follow the thread under IMS ID 551 (under dates raised and references).

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Australia also expressed concern about compliance with the Code of Good Practice for the Preparation, Adoption, and Application of Standards in Annex 3 of the TBT Agreement. China had advised that its government would take into full consideration calls from domestic and international communities. However, neither the Ministry of Environmental Protection (MEP) nor SAC had provided for a 60-day comment period on the draft standards in either the domestic consultation process or the notification to the WTO, according to Article L of the Code. Finally he

asked for an explanation as to how comments from other Members had been or would be taken into account given that consultation process was already closed. Australia urged China to reconsider the standards and allow for a comprehensive consultation process.

The representative of the European Union raised concerns regarding the Chinese environmental protection control standards for imported solid waste as raw materials. The full statement is contained in G/TBT/W/472.

The representative of the United States supported the comments raised by Australia and the EU and asked that the concerns raised earlier in the meeting also be considered under this STC.133

The representative of China responded to the concerns raised. The full statement is contained in G/TBT/W/547.

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

2560) (IMS ID 556134)

4.262. The representative of the United States noted that Thailand had not yet notified the measure, despite flagging at the March 2017 Committee meeting that it would do so, to enable trading partners the opportunity to comment. She did however express appreciation that Thailand had issued guidelines to the measure in March 2018 and that full implementation had been

deferred until September. Nevertheless, the guidelines did not clarify a number of her delegation's concerns, such as what testing was required. Given that full entry into force was due in September

2018, Thailand was urged to notify the measure as soon as possible in an effort to resolve US concerns before trade became impacted, and requested that Thailand delay enforcement until trading partners' concerns had been taken into account.

4.263. The representative of the European Union expressed concern with regard to certain elements in the Thai requirement to provide a Certificate of Analysis for the marketing of fermented and distilled alcoholic beverages (wines, spirits or beer). Whilst supporting the

importance of ensuring the protection of public health, the EU was nonetheless concerned that the testing criteria and methods foreseen for the issuing of the Certificate of Analysis may unduly impact trade in alcoholic beverages. Her delegation appreciated that the grace period for submitting samples or certificates of analysis after importation had been extended until 14 September 2018. Also appreciated was the adoption on 22 March 2018 of implementing guidelines on the submission of alcohol beverages samples for quality compliance testing as part of

the import licence application, in particular the clarification that samples had to be submitted only

once, unless there was a change in the production process, and that their size should be of at least 0.50 litres.

4.264. Furthermore, she expressed appreciation for the openness of the Thai Excise Department to address remaining concerns. Based on a recent discussion on 18 June between her delegation and the Thai Excise Department in Bangkok, Thailand had indicated its intention to amend the Thai Industrial Standards Institute (TISI) standards and accept producer self-certifications as of 15 September 2018. Pending the amendment of TISI standards, market surveillance would take

into consideration the differences in testing methods and thresholds in international standards (including exemptions for sweet wines in OIV standards) in order to avoid market disruptions. The EU requested confirmation on these next steps and remained available to work with Thailand on the review of the TISI standards, including through discussions at expert level on substances

133 China — Catalogue of Solid Wastes Forbidden to Import into China G/TBT/N/CHN/1211

(paras. 4.194. 4.197. ) 134 For previous statements follow the thread under IMS ID 556 (under dates raised and references).

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for which testing was not foreseen in international standards. Thailand was encouraged to notify the requirement to the TBT Committee, sufficiently in advance to allow Members to become acquainted with it and submit comments in accordance with Article 2.9.2 of the TBT Agreement.

4.265. The representative of Australia reiterated previously raised concerns.135

4.266. The representative of Japan expressed concerns on this issue and recalled Thailand flagging at the March 2018 Committee meeting that the competent authority was in the process of

preparing a TBT notification for the measure. His delegation sought an update on the notification and requested that a sufficient comment period be provided. In addition, Thailand was urged to amend the issue appropriately and sufficiently before entry into force, taking into account Members' comments.

4.267. The representative of New Zealand acknowledged and supported Thailand's right to

introduce new regulations to address specific public health concerns. Her delegation appreciated

that in seeking to address the harmful use of alcohol, the technical regulation was directed towards achieving a legitimate public health objective. She stated, however, that New Zealand exporters faced ongoing uncertainty regarding the implementation of the regulations and were keen to work with the Thai government and importers to comply with the new requirements. Thailand was requested to update Members on the progress of any implementing guidance.

4.268. The representative of Thailand stated that the Thai ministerial notification on obtaining permission to import liquor into Thailand, issued in accordance with the excise tax act of 2017,

required any person to "submit samples of liquors to be imported to the director general for quality examination and analysis prior to file an application for permission or subject to certification of source of liquor samples analyses. Later they qualify in accordance with the industrial product standards provided that the certification be issued by the agencies as is done by the Director General to be the liquor coordination and analyses agencies or the agencies of foreign governments or the agencies acknowledged by foreign governments to have duty control the

liquor production or the liquor producers in foreign countries" (quotation taken from an official

translation of the ministerial notification).

4.269. He informed Members that the justification for requiring this sampling or certificate of analysis was to protect consumer health and safety. The ministerial notification had been in force since 16 September 2017 and was now in the process of being notified to the TBT Committee. However, the excise department had issued another notification extending the period of entry into force of the measure in order to provide flexibility whereby importers were allowed to provide

sampling or certificate of analysis to the excise department within 30 days after importation. This flexibility had been extended to 14 September 2018.

4.270. Thailand explained that the sampling or certificate of analysis need only be provided once for each product, but that any change in production procedure required liquor samples to be submitted for quality analysis. There was, however, no requirement for a product-wide sample submission. In addition, he clarified that the issuance of this ministerial regulation was intended to

facilitate liquor importation into Thailand, given that importers were to submit samples of liquors

for quality examination and analysis to the excise laboratory prior to applying for import permission, and that there would be no charges associated with this submission. Alternatively, if samples were not submitted, a certificate of analysis would be accepted, issued by either the government in accordance with the industrial standard that aligns with international practices, or by government-recognized agencies responsible for quality and production certification.

4.271. Thailand said that other authorities were in the process of considering the certification for liquor producers in accordance with industrial standards that aligned with international practices.

Regarding the testing criteria and methods for liquor importation, he confirmed that Thailand applied Thai industrial standards or TISI standards, and therefore the issue regarding the reviewing of the standards had been taken into account. Thailand reaffirmed its determination to guarantee consumer protection and safety to ensure flexibility and not trade barriers.

135 G/TBT/M/74, para. 2.47.

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4.4.49 Israel — Addendum to the Pharmacist Regulations (Cosmetics 5778-2018) G/TBT/N/ISR/709/Add.2 (IMS ID 552136)

The representative of the European Union reiterated previously raised concerns.137

The representative of the United States thanked the Ministries of Health and Economy and the Knesset for agreeing to temporarily suspend discussion in committee of the current draft of the

Pharmacists Regulation for Cosmetics. While both the US government and industry appreciated the efforts of Israel to align its cosmetics regulations with international best practices via a transition from a notification of marketing system, there were still concerns that the regulation may cause trade barriers, if reintroduced in its current form. The US also believed that the current version of the proposed regulations, for which the Knesset Committee suspended review, were disproportionate to the lower risk to consumer health associated with cosmetic products that were

not regulated as pharmaceutical products. The US was also particularly concerned with the requirement in the draft that the Responsible Person (RP) be an individual, and not a business entity as such. In US's view, besides not being in conformity with international best practices, such a requirement was not realistic to implement, since no one individual could be responsible for sometimes thousands of individual products that would need to be managed. Another source of concern was how Product Information Files would be managed, and the potential requirements that manufacturers and their local distributors would be responsible for providing product

information for parallel imports. Given the extensive nature of the comments and the potential trade barriers raised by the ordinance, the US ask Israel to re-notify any revised draft (if it was reintroduced or reconsidered) to the TBT Committee at an early enough stage of at least 60 to 90 days so as to allow stakeholders to provide comments, and for those comments to be taken into account before issuance of the final version of the regulation. The US also ask that Israel provide at least two years for industry to adapt to the new measures once the ordinance was adopted and went into force.

The representative of Switzerland supported the comments made by other delegations.

The representative of the Republic of Korea expressed his delegation's ongoing interest in the development of the "Addendum to the Pharmacist Regulation" and requested Israel to provide information on the developments of the regulation, and its implementation date.

The representative of Israel explained that the process of aligning Israel's cosmetic regulation with international best practices had started several years ago. The purpose of the

regulation was to open the market to more competition while still maintaining the safety and quality of the cosmetics market in Israel. This was part of a broader effort to further lower barriers for imports into the Israeli market in order to improve the quality and prices of all goods for the benefit of consumers. The process involved aligning the new regulations with those of its major trading partners. The Israeli Government therefore valued and took into consideration the contribution and experience-sharing of industry and Israel's trading partners in formulating the regulations suitable for the Israeli environment. Israel took note of the issues raised in the

Committee. Members were familiar with and had been actively involved in the process of developing the regulations.

4.4.50 Italy — Labelling requirements of the origin of grains used in the preparation of dried pasta (IMS ID 530138)

The representative of Canada recalled that many interventions in the Committee underlined the importance of respecting the transparency and notification obligations set out in the TBT Agreement to ensure a non-discriminatory and predictable regulatory environment that

facilitated open trade. Canada was particularly concerned with the way many EU member State labelling measures had been allowed to enter into force over the previous two years without ever being notified to the TBT Committee. For instance, Italy's country-of-origin labelling measure for pasta products had come into effect in February 2018, but the path that it had taken to entry into

136 For previous statements follow the thread under IMS ID 552 (under dates raised and references). 137 G/TBT/M/74, para. 2.19 and statement circulated in full in G/TBT/W/473. 138 For previous statements follow the thread under IMS ID 530 (under dates raised and references).

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force had skipped many steps required by WTO rules. Italy's pasta measure had been published in the Official Gazette of the Italian Republic on 17 August 2017. Despite repeated requests by Canada to both Italy and the European Commission, the measure had never been notified to the TBT Committee, despite the measure's evident and clear potential to impact trade, as well as the Committee's decisions regarding transparency. Canada was disappointed with the lack of transparency demonstrated by Italy and the European Commission and with the fact that Canada

and other WTO Members had not been provided with an opportunity to comment on the measure in the normal course of procedures. Canada was also disappointed that trading partners had not been afforded a proper transition period to adapt to the measure, which would normally follow the notification of the final measure. Canada once again requested that the EU, Italy, and any other member State notify all country-of-origin labelling measures to the TBT Committee, in order to comply with their transparency obligations under the TBT Agreement.

The representative of Brazil expressed support for the concerns raised by Canada.

The representative of Argentina raised concerns regarding the labelling requirements of the origin of grains used in the preparation of dried pasta. The full statement is contained in G/TBT/W/552.

The representative of Mexico supported concerns raised by Canada, Brazil and Argentina.

The representative of the European Union, referring to the responses provided in previous TBT Committee meetings139, recalled that on 12 May 2017, Italy had notified to the Commission a

draft decree on the origin indication of durum wheat for pasta, in accordance with the specific notification procedures established in Regulation (EU) 1169/2011 on the Provision of Food Information to Consumers, but had withdrawn the notification on 25 July 2017. As a result, the Commission had not pursued the assessment of the measure. The Italian decree had entered into application on 17 February 2018 and would be in force for a limited period, until 31 December 2020. The decree stated that the national measure would lose its effectiveness from the date of

the entry into force of the European Commission's implementing act determining how the

indication of the origin of the primary ingredient was to be provided, where different from the final food. She added that the Commission Implementing Regulation (EU) 2018/775 of 28 May 2018, laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food, which had been notified to the TBT Committee, had entered into force on 1 June 2018 and would apply from 1 April 2020. This Regulation was of great importance in the context of the

increasing the number of national notifications and should reduce the need for further resort to national provisions regulating indication of origin. The EU had taken note of Members' concerns and was available for bilateral discussions.

4.4.51 Viet Nam — Alcoholic Beverages, G/TBT/N/VNM/86 (IMS ID 532140)

The representative of Mexico recalled that Viet Nam first notified this measure on 26 August 2016, in document G/TBT/N/VNM/86. However, at previous Committee meetings, Viet Nam

had stated that there was a new version of the decree in question, in the process of being

approved for publication, and that this version would be notified to the WTO and subject to public consultation for the receipt of comments. Mexico said that it had received, through alternative channels, a version of the decree in Vietnamese dated 14 May 2017 (No. 105/2017/ND CP), which, to Mexico's knowledge, had not been notified to the TBT Committee, and which would infringe Article 2.9 of the TBT Agreement on transparency, notification and the time frame for public consultation.

Regarding the non-notified version, Mexico had a specific concern about Article 31 which

established specifications for imported samples. In particular, this Article indicated that enterprises, including those without a certificate for the industrial production of alcohol or the distribution of liqueurs, were permitted to import alcoholic beverages with the aim of carrying out procedures to obtain certificates demonstrating conformity with regulations or food safety standards, up to a maximum of three litres per label.

139 G/TBT/M/73, para. 2.176. 140 For previous statements follow the thread under IMS ID 532 (under dates raised and references).

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On the understanding that the three litres authorized per label referred to only one brand, Mexico said this article would have a negative impact on imports of alcoholic beverages, as three litres was a very small amount. The logistical costs would therefore increase and the lack of a specific agreement with an enterprise in Viet Nam would create losses that would make it less attractive for shipments of such samples to meet the certification requirements, and would set a precedent for the marketing of this type of product in Viet Nam. Furthermore, the provision could

infringe Article 2.2 of the TBT Agreement, insofar as it established regulations that created unnecessary barriers to trade and made the measures more stringent than necessary. Considering the above, Mexico requested Viet Nam to: (i) provide a clearer explanation of the "three litre limit per label" for the importation of samples, if Mexico's understanding of the permitted limit by label was erroneous; and (ii) supply information on the status of the decree in question and the estimated date of notification to the TBT Committee, and on the time frame for public consultation.

The representative of Viet Nam thanked Mexico for comments and clarification in the

bilateral meeting held that morning. She noted that the Law on Alcohol Trading had been notified to WTO by Viet Nam on 26 August 2016 (G/TBT/N/VNM/86) with a comment period of 60 days from the date of notification. After this period, Viet Nam had received comments from stakeholders and the draft decree had been amended accordingly. The decree had been promulgated on 14 September 2017 and had come into force from 1 November 2017. All comments on the implementation of the decree would be delivered to Viet Nam's competent agencies for further

study and response.

5 EIGHTH TRIENNIAL REVIEW - CHAIR'S REPORT AND NEXT STEPS

The Chairperson recalled that the Committee had agreed on the timeline and approach to the Eighth Triennial Review at the June 2017 meeting (G/TBT/W/450). Following Tuesday's informal meeting (on the 8th Triennial Review) the Committee now had an advance copy of the Chair's report which covered the full list of all proposals tabled in the context of the 8th Triennial Review.141 With respect to next steps, the Chairperson said that the Secretariat would, over the

summer, prepare a first draft of the report based on Members' submissions. Members would then be invited to submit comments on that draft.142 An informal meeting on 20 September had been tentatively scheduled to discuss the draft. Further informal meetings would be held as necessary ahead of the Committee's November meeting.143

6 TECHNICAL ASSISTANCE

The representative of the United States reported on upcoming and recent events that the

United States had conducted. This included activities in India (USTDA), Africa (USAID Standards Alliance) and a commercial law development program in Ukraine – as well as transparency-related activities in Afghanistan and Pakistan. The full statement is contained in G/TBT/W/559.

The representative of Canada said that Canada's Enquiry Point had been working with the ITC on a capacity building exercise similar to one provided last year, with Trinidad and Tobago – in this case it would be with Afghanistan. Hopefully this would not duplicate work the US was

undertaking.

The Secretariat provided an update on ePing; the full statement is contained in G/TBT/GEN/249.

7 OBSERVERS

7.1 ISO: ongoing revision of ISO/IEC Guide 59

The Chairperson recalled that at the last meeting of the Committee the United States had raised a number of issues regarding ongoing work to revise the 1994 Guide 59 on the Code of

141 Comments from Members on the draft report were taken into account and the report was

subsequently circulated as JOB/TBT/240/Rev.4 on 3 July 2018. 142 The draft report was subsequently circulated on 10 August 2018 in document JOB/TBT/248. 143 A follow-up fax to the meeting with dates and deadlines was circulated on 25 June 2018. The fax is

contained in RD/TBT/246.

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Good Practice for Standardization.144 Accordingly, the ISO had agreed to make a presentation on the topic.

The representative of the ISO145 introduced the revision of ISO/IEC Guide 59 Code of Good Practice for Standardization. Selected points in no particular order are summarized below. The full presentation is contained in G/TBT/GEN/248.

a. The current Guide is voluntary in nature; was first published in 1994, has not previously

been revised and does not have a clear scope;

b. ISO guides are documents that provide advice to both national standards bodies – those who are actually developing standards – and to standards writers. They are prepared by either an ISO group reporting to the ISO technical management board (TMB), or by the ISO/IEC Joint Coordinating Group. These are not technical committees.

c. For the revision of Guide 59, the ISO TMB and the IEC Standardization Management

Board (SMB) created a Joint Working Group composed of representatives nominated by the ISO/TMB and IEC/SMB. The working group is composed of 15 experts acting in their personal capacity. Under the current timeline, the Guide will be published in 2019.

d. The purpose of the revision is to align it with the TBT Committee's Six Principles146 and

the WTO TBT Agreement's Code of Good Practice (Annex 3). Moreover, the structure –

as well as the content and language used – is being updated and clarified to allow easier application. In addition, the general format and structure is being aligned with current rules for drafting of ISO/IEC deliverables.

e. The revised guide will apply (on a voluntary basis) to national members of IEC and ISO and has two distinct sections: one on "Principles of Standards Development" (Section 4),

and another on "Guidance to the implementation of Code of good practice for the preparation, adoption and application of standards" (Section 5). The latter (Section 5)

does not provide an official interpretation of Annex 3 of the TBT Agreement.

f. Regarding the process, there will be opportunity for comment at the "Enquiry DIS" stage (Stage 4 in slide 15 in G/TBT/GEN/248); at this point, the document will go out to every single ISO and IEC member. Comments can be made through national member bodies over a period of 16 weeks.

The representative of the United States noted that she had learned about the ongoing

revision through one person in the US Government who had expressed concerns because of the lack of participation of the right people in the process. It had been noted that the ISO standards at issue had been developed in 1994 and that the WTO TBT Agreement had come into force just after that time. Therefore, the fact that the standard was being revised was confusing. Also, the work was being done in a technical management board with only 15 experts developing this guide while

the WTO's Annex 3 Code of Good Practice (Annex 3 of the TBT Agreement) - or even the TBT Committee's Six Principles – had involved the participation of all WTO Members.

She said that US lawyers had expressed concern about this work. For instance, there was concern about how the standard was being developed and how national standards bodies might use that guide to interpret the WTO Agreement itself. Even with a disclaimer (to the effect that the standard did not interpret the WTO Agreement) national standards bodies and standards developers all over the world were likely to use the document to implement their practices, or they might create documents of their own. And although the ISO argued that it was limiting the applicability of the standard to only ISO and IEC members, this did not mean that any other

organisation could develop a similar guide resulting in a situation where there were several

144 The full US statement from the previous meeting is contained in G/TBT/W/471. 145 Mr. Sean McCurtain, Director, Conformity Assessment and Consumer Matters, ISO Central

Secretariat. 146 G/TBT/1/Rev.13, p.54.

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competing guides; what if, for example, Codex decided to develop a guide like this? Which one would apply?

Thus, from the perspective of US lawyers, this work was troubling. Why would an outside organization interpret agreements that were made in the WTO? When developing a guide there would always be the chance that someone reading would misinterpret it and then claim that they were using the ISO Guide to comply with good practices. The US main concern was that they did

not want this guide to be used to interpret either the TBT Agreement's Code of Good Practice, or the Committee decisions because this was inherently a function of the WTO.

The representative of South Africa thanked the US for having brought the issue to the attention of the Committee, as well as the ISO for the presentation. South Africa too was concerned mainly because not all WTO Members had full membership status in the ISO to contribute to the revision of Guide 59. Nevertheless, South Africa recognized that ISO and IEC had

the right to amend their own Guide 59. It needed to be clarified in this regard that Annex 3, the Code of Good Practice (of the WTO TBT Agreement) was not the same as Guide 59 of ISO and IEC. Of course, only WTO Members could change Annex 3 of the TBT Agreement. The new, revised Guide 59 would not necessarily result in any change of Annex 3. Therefore, South Africa encouraged Members to engage in the process when the revised Guide went for ballot, and that they make an informed decision at that point. South Africa requested that the ISO and IEC keep Members informed of developments in the revision of Guide 69.

The representative of ISO said that the views of the US and South Africa would be fed back to the working group that were developing the standard. He emphasized again that the intent of the revision was not to interpret, and if the document was not clear in that respect, the matter needed to be looked into again. The ISO made a commitment to ensure that the WTO was kept informed of the progress of the document (including when the DIS ballot is launched).

The representative of the United States asked if the WTO's lawyers were aware that an

outside organization was developing a guidance's document that closely mirrored a WTO

Agreement as well as one of its Committee's key decisions (on international standards), and, also if it could opine on the matter?

The representative of the Secretariat said he did not think the Legal Affairs Division was aware of this issue; the WTO did not systematically look at guidance developed by other organizations unless it became a matter of relevance in a dispute settlement procedure. Whether or not the WTO LAD would look into the matter would depend on whether there was a specific

request from Members for it to do so.

7.2 Updates from Observers

Updates were provided from the following organizations: Codex (G/TBT/GEN/251); CROSQ (G/TBT/GEN/252); UNECE (G/TBT/GEN/247), UNIDO (G/TBT/GEN/250), BIPM and IEC.

The representative of Canada referred to the UNECE report regarding on-going work on gender and standards. He said that this tied in nicely with Canada's proposal on standards and gender (G/TBT/W/532) and provided examples. For instance, in the context of the testing of

seatbelts, crash test dummies that were used for automotive testing were not always representative of the population, including with respect to pregnant women. Similarly, Canada's health departments in their assessment of the efficacy of pharmaceutical products and medical devices had not always taken into account differences in gender.

7.3 Pending Requests

The representative of the European Union said that his delegation attached importance to the issue of accreditation and valued the important work that ILAC and IAF did in terms of

international accreditation schemes, and the positive impact that these had on facilitating trade. However, it had to be recognized that ILAC and IAF did not meet the formal requirements for

observer status. Rule Number 11 contained in document G/TBT/1/Rev.13 (page 76) read: "Representatives of international intergovernmental organizations may attend the meetings as observers on the invitation of the Committee in accordance with the guidelines in Annex 2 to these

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Rules". In the EU view, since ILAC and IAF were not international intergovernmental organizations, it was not possible to agree to the request.

The representative of Kenya expressed her country's support for IAF and ILAC as observers at the WTO TBT Committee due to the important role the two organizations played in the facilitation of trade and eliminating unnecessary technical barriers to trade. Kenya's full statement is contained in document G/TBT/W/560.

The representative of Trinidad and Tobago, a member of ILAC and an associate member of IAF, supported these organizations' request for observer status in the Committee. Clearly, she said, the work of these two organizations facilitated trade - allowing small developing countries to achieve market access in important markets.

The representative of South Africa referred to his statement expressing support for ILAC

and IAF at the last meeting of the Committee147 and added that South Africa supported the

statements made by Kenya, and Trinidad and Tobago. However, listening to the European Union, South Africa had a different interpretation of the Committee's Rules of Procedure and referred specifically to: (i) the 5th and 6th paragraphs of Annex B (G/TBT/1/Rev.13, p.81)148; and, Article V para 2 of Marrakesh Agreement Establishing the World Trade Organization.149 South Africa was of the view that organizations like ILAC and IAF could be granted observer status although they were not intergovernmental organizations. These organizations were directly involved in the work of the Committee and there was therefore no reason why they could not be invited to become observers.

There was a need for a clear interpretation of the rules. He proposed that the matter be referred to the WTO Legal Affairs Division for clarification so that the Committee could get a clearer understanding of the issue and whether it was possible to grant ILAC and IAF observer status.

The representative of Chinese Taipei supported the application of IAF and ILAC for observer status in the TBT Committee. He stressed that accreditation was mentioned in Article 6.1.1 of the TBT Agreement. Also, the use of accreditation to qualify conformity assessment bodies was one of

the approaches to facilitate the acceptance of conformity assessment results. MRAs developed by

IAF and ILAC were good examples of internationally recognized schemes and were widely used by Members; hence, these two organizations played important roles in eliminating unnecessary barriers to trade and reducing costs. Moreover, the TBT Committee could benefit from the participation of IAF and ILAC because Members could follow closely the progress of MRAs' development and have their concerns conveyed directly. On the legal issues, it was not clear that international non-governmental organization – such as ILAC and IAC – could not be allowed to

become observers under the Committee's procedures mentioned above.

The representative of Uganda confirmed his delegation's support for ILAC and IAF.

147 G/TBT/M/74, para. 5.4 and G/TBT/W/525. 148 Which reads:

Requests for observer status shall be considered on a case by case basis by each WTO body to which such a request is addressed, taking into account such factors as the nature of work of the organization concerned, the nature of its membership, the number of WTO Members in the organization, reciprocity with respect to access to proceedings, documents and other aspects of observership, and whether the organization has been associated in the past with the work of the CONTRACTING PARTIES to GATT 1947.

In addition to organizations that request, and are granted, observer status, other organizations may attend meetings of the Ministerial Conference, the General Council or subsidiary bodies on the specific invitation of the Ministerial Conference, the General Council or the subsidiary body concerned, as the case may be. Invitations may also be extended, as appropriate and on a case-by-case basis, to specific organizations to follow particular issues within a body in an observer capacity

149 Which reads: "Article V Relations with Other Organizations 1. The General Council shall make appropriate arrangements for effective cooperation with other intergovernmental organizations that have responsibilities related to those of the WTO. 2. The General Council may make appropriate arrangements for consultation and cooperation with non-governmental organizations concerned with matters related to those of the WTO."

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The representative of the United States supported the comments made by South Africa, Chinese Taipei and Uganda. She also agreed with South Africa's statement that the matter was not clear. Currently there were observers in the TBT Committee that were not wholly intergovernmental: both the ISO and IEC had private members and were not wholly intergovernmental organizations. Therefore, the United States was not sure on what basis these organizations were allowed observer status while ILAC and IAF were not.

The representative of Brazil supported the applications of ILAC and IAF.

The representative of China valued the accreditation and the contribution made by ILAC and IAF in facilitating international trade and agreed with the statements of South Africa and the United States. China therefore supported granting observer status to both ILAC and IAF.

The representative of New Zealand recognized that while IAF and ILAC were not

intergovernmental organizations. However, on the basis that the Committee had approved

observers status for other non-intergovernmental organizations in the past – as others had pointed out – and recognizing the significant relevance of their work to the Committee, New Zealand supported the application of both ILAF and IAF.

The representative of Mexico supported the application of IAF and ILAC.

The representative of Canada joined others and strongly supported the application of ILAC and IAF for observer status in the TBT Committee. As South Africa had eloquently explained, as well as others, the Committee would be remiss not to accept the request given these two

organizations' contribution to its work.

The European Union responded that his delegation agreed with the many remarks made in respect of the value of the activities of ILAC and IAF. By contrast, the EU disagreed with South Africa about there being any lack of clarity about whether non-governmental organizations could

be granted observer status. The word "organizations" in paragraph 5 and 6 of Annex B to which South Africa had referred, meant, as explained in the first paragraph of Annex B, international intergovernmental organizations.150

The representative of South Africa said that the term "non-governmental organizations" was mentioned in both the Marrakesh Agreement Establishing the World Trade Organization and in Committee's rules and procedures. This needed to be taken into consideration.

The Chairperson noted that while there were many voices in support of ILAC and IAF for observer status in the Committee, there was no agreement to grant observer status at the current time. She also recalled that South Africa had asked the Secretariat for an interpretation of the

Committee's rules of procedure.

The Secretariat said that it would consult with the Legal Affairs Division, if that was the

Committee's wish. On a more general point, in terms of rules of procedures the issue was really with the Committee itself: the Committee had created the rules and could decide how it wished to interpret them, including with respect to changes, amendments or exceptions.

The Chairperson asked if Members wished to consult with the Secretariat's Legal Affairs Division?

The representative of South Africa reiterated the need for clarity on the rules. The specific question would be: if, in terms of existing rules and procedures of the TBT Committee, and the provisions of Article V.2 of the Marrakesh Agreement Establishing the WTO, whether ILAC and IAF could be granted observers status in the Committee.

150 The first paragraph of Annex B (G/TBT/1/Rev.13, p.81) reads:

"The purpose of observer status for international intergovernmental organizations (hereinafter referred to as "organizations") in the WTO is to enable these organizations to follow discussions therein on matters of direct interest to them."

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The Chairperson said that as Members appeared comfortable with this proposal, it was so agreed. Moving on, she asked if Members had any other comments on the other six pending requests for observer status listed in G/TBT/GEN/2/Rev.14.

The representative of Turkey reiterated his delegation's support for the application from the Standards and Metrology Institute for Islamic Countries (SMIIC) made at the last meeting of the Committee.151

The representative of Pakistan echoed Turkey's statement. As an active member of the SMIIC, Pakistan believed that the aims of SMIIC and of the TBT Committee were concurrent; they both facilitated trade through the harmonization of standards, technical regulations, and conformity assessment procedures.

The representative of Egypt supported the application from SMIIC.

The representative of Uganda supported consideration of the application of SMIIC at the

November meeting of the Committee.

The Chairperson asked the Committee if Members were in a position to grant observer's status to SMIIC?

The United States said her delegation had understood that only the request from ILAC/IAF would be considered at the current meeting. Therefore, without prejudice to SMIIC, the issue would need to be reverted to in November.

In response, the Chairperson said that it would not be possible for the Committee to agree

on observer status for SMIIC at the current meeting. She nevertheless thanked Members for their engagement and asked the Secretariat to keep relevant organizations updated on developments. She proposed that the Committee would revert to the full list of pending observer requests

contained in document G/TBT/GEN/2/Rev.14 at the November Committee meeting and asked that Members come prepared to discuss the list.

8 DATE OF NEXT MEETING

The next regular meeting of the Committee will be held on 14-15 November 2018, with one

day set aside for discussion on the Eighth Triennial Review on 13 November 2018.

__________

151 G/TBT/M/74, para. 5.8 and G/TBT/W/526.