46
RESTRICTED G/TBT/M/77 15 May 2019 (19-3400) Page: 1/46 Committee on Technical Barriers to Trade MINUTES OF THE MEETING OF 6-7 MARCH 2019 INTERIM CHAIRPERSON: MR. JOSE MANUEL CAMPOS ABAD Note by the Secretariat 1 1 ADOPTION OF THE AGENDA ........................................................................... 1 2 STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2...................................... 1 3 SPECIFIC TRADE CONCERNS (STCS) .............................................................. 2 3.1 Reported resolutions ....................................................................................... 2 3.2 Withdrawn concerns ....................................................................................... 2 3.3 New concerns ................................................................................................ 2 3.4 Previously raised concerns ............................................................................. 11 3.5 Exchange of Experiences ............................................................................... 45 4 TWENTY-FOURTH ANNUAL REVIEW ............................................................. 46 5 TECHNICAL COOPERATION ACTIVITIES ....................................................... 46 6 UPDATING BY OBSERVERS ........................................................................... 46 6.1 Pending requests .......................................................................................... 46 7 ELECTION OF THE CHAIRPERSON ................................................................. 46 8 DATE OF NEXT MEETING............................................................................... 46 1 ADOPTION OF THE AGENDA 1.1. The Committee adopted the agenda contained in WTO/AIR/TBT/13. 2 STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 2.1. 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/42), issued on 25 February 2019. Information on the list of statements is available on the TBT Information Management System (TBT IMS). 2.2. The representative of Canada informed the Committee that Canada's Cabinet directive on regulation had recently entered into force. This document set out the Government's expectation and requirements in the development, the management and the review of federal regulations. The strength of Canada's regulatory system was recognized by the OECD and this new directive built on its strong foundation by emphasising a lifecycle approach to the development, management and 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.

RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

Page 1: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

RESTRICTED

G/TBT/M/77

15 May 2019

(19-3400) Page: 1/46

Committee on Technical Barriers to Trade

MINUTES OF THE MEETING OF 6-7 MARCH 2019

INTERIM CHAIRPERSON: MR. JOSE MANUEL CAMPOS ABAD

Note by the Secretariat1

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

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

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

3.1 Reported resolutions ....................................................................................... 2

3.2 Withdrawn concerns ....................................................................................... 2

3.3 New concerns ................................................................................................ 2

3.4 Previously raised concerns ............................................................................. 11

3.5 Exchange of Experiences ............................................................................... 45

4 TWENTY-FOURTH ANNUAL REVIEW ............................................................. 46

5 TECHNICAL COOPERATION ACTIVITIES ....................................................... 46

6 UPDATING BY OBSERVERS ........................................................................... 46

6.1 Pending requests .......................................................................................... 46

7 ELECTION OF THE CHAIRPERSON ................................................................. 46

8 DATE OF NEXT MEETING............................................................................... 46

1 ADOPTION OF THE AGENDA

1.1. The Committee adopted the agenda contained in WTO/AIR/TBT/13.

2 STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2

2.1. 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/42), issued on 25 February 2019. Information on the list of statements is available on the TBT Information Management System (TBT IMS).

2.2. The representative of Canada informed the Committee that Canada's Cabinet directive on

regulation had recently entered into force. This document set out the Government's expectation and requirements in the development, the management and the review of federal regulations. The strength of Canada's regulatory system was recognized by the OECD and this new directive built on its strong foundation by emphasising a lifecycle approach to the development, management and

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.

Page 2: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 2 -

review of regulations. The principle of openness and transparency throughout the regulatory lifecycle was fundamental to GRP. Regulators had to engage stakeholders early, often and throughout the development, management and review of regulations in Canada. These requirements meant that regulators worked with the foreign ministry to notify trading partners of changes to regulations which could impact trade. The directive was also expected to help small business by lowering the administrative burden and cost. More rigorous cost benefit analysis coming from the directive would

ensure regulators did seek to lower those costs and impacts on small businesses when developing regulations. The new policy required that departments and agencies were to conduct a review of their existing regulatory stock to ensure that regulations continued to meet their intended policy objectives sufficiently and effectively. Canada maintained a one-for-one rule which meant that as new regulations were brought in, older ones which no longer met their intended objectives could be removed. Canada also sought regulatory cooperation be emphasised in this new policy so as to foster

international trade, to reduce trade barriers and to provide consumers with greater choice. Therefore, when proposed regulations or standards were different from international practice, those

of other jurisdictions or trading partners, Canadian regulators were required to explain the difference and reasoning in the publicly available regulatory impact analysis statements which would accompany all regulatory proposals.

3 SPECIFIC TRADE CONCERNS (STCS)

3.1. The Chairperson informed the Committee that lengthy statements would be prepared for

circulation separately and referred to in the minutes (see paragraph 3.4 below for an example). He said that this was done because such statements were often technical and difficult to summarize without compromising accuracy and detail. At the last meeting, 42 statements had been circulated this way; this had significantly expedited the preparation of the minutes. Prepared statements would be sent to delegations for checking prior to circulation.

3.1 Reported resolutions

3.2. There were no reported resolutions.

3.2 Withdrawn concerns

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

a. China IT banking equipment;

b. GCC handling of Energy drinks.

3.3 New concerns

3.3.1 Israel - Bill on the Restriction on Advertising and Marketing of Tobacco Products

(Amendment No.7, 5778-2018) G/TBT/N/ISR/730 (IMS ID 5732)

3.4. The representative of the Dominican Republic raised concerns with Israel's bill on the restriction on advertising and marketing of tobacco products. The full statement is contained in G/TBT/W/603.

3.5. The representative of Canada expressed interest in the ongoing international developments regarding tobacco control measures, and the interaction of such measures with both international trade and public health. He said that tobacco use was a significant problem, in Canada and around

the world. In Canada alone, 45,000 people died annually as a result of smoking – a leading cause of preventable death and disease. Tobacco products were also the only good to be the subject of a legally binding health treaty, the World Health Organization Framework Convention on Tobacco Control. Tobacco packaging and the products they contain were powerful promotional vehicles. Research had shown that plain tobacco packages reduced their appeal and attractiveness, especially among youth.

2 For previous statements follow the thread under IMS ID 573 (under dates raised and references).

Page 3: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 3 -

3.6. The Government of Canada committed to introduce plain packaging requirements for tobacco products, similar to those of Australia and the United Kingdom, publishing proposed regulations in June 2018. These requirements were an expression of the right to regulate in the interest of public health in Canada. Canada supported the Panel Report findings in the Australia-Tobacco Plain Packaging dispute, which, he said, confirmed that WTO Members had regulatory flexibility to take legitimate public health measures, such as plain packaging measures for tobacco products. Indeed,

many countries had implemented plain packaging requirements or were considering similar measures to protect the health of their citizens.

3.7. The representative of Israel said that the Law proposal had been notified to the TBT Committee in January 2014 as notification G/TBT/N/ISR/730. One of the major changes in the proposal was the change in the name of the law as well as in many of the paragraphs from referring only to "tobacco products" to "tobacco and smoking products". The proposal defined "smoking products" which also

included cigars. Furthermore, in paragraph 11 of the Law proposal it was stated that the Minister of

Health was allowed to set regulations on the design of packaging of tobacco or smoking products. She recalled that at the time, Israel had received a letter from the Dominican Republic setting out their various concerns that the Law proposal would "…allow the Minister of Health to mandate a unified pack design for tobacco products…", including concerns over the removal of all design elements of trademarks and geographical indications from tobacco products and the risk that by "…eliminating the valuable differentiating role performed by trademarks and geographical

indication…" it may result in a higher consumption and more illicit trade in tobacco goods. In addition, the Dominican Republic had urged Israel to delay the adoption of a plain packaging measure for tobacco products until the issuance of the final panel report to the parties in Australia — Tobacco Plain Packaging. The report had been circulated on 28 June 2018.

3.8. In light of the above, her delegation was of the opinion that Israel had provided trading partners with the opportunity to transmit their concerns and comments regarding the packaging measures and that trading partners had availed themselves of this opportunity. Israel had indeed taken into

consideration the comments received and the recommendations of the Panel in the above-mentioned

report, in finalizing the measure. The measure had recently been adopted and published, with a one-year implementation period in order to allow trading partners to make the necessary adjustments.

3.3.1.1 Trinidad and Tobago - Regulation related to the prohibition, of commercialization and importation of plastic products of polystyrene (IMS ID 5743)

3.9. The representative of the Dominican Republic said that on 27 July 2018, the Government of

Trinidad and Tobago had announced the prohibition of the marketing and importation of polystyrene plastics, through the Minister of Planning and Development. The ban included cups and food containers, as well as plates, drinking straws and other utensils, and would be implemented in 2019. It was her delegation's understanding that the measure could be defined as a technical regulation under Annex 1.1 of the TBT Agreement, as it laid down certain characteristics with which compliance was mandatory, by providing that exports of plastic products must not be made from polystyrene. The Dominican Republic considered the measure to be more restrictive than necessary, in

contradiction with the provisions of Article 2.2 of the TBT Agreement. Furthermore, the measure

was deemed contrary to Article 2.1 of the Agreement, as it would have a harmful effect on imports of polystyrene products. She stated that in this regard the measure was inconsistent with the provisions of Article III:4 of GATT 1994 and not justified by Article XX(g); rather, it was a disguised restriction on international trade. As the measure had not been notified to the TBT Committee, her delegation was also concerned that it contradicted the transparency provisions established under the TBT Agreement. Trinidad and Tobago was asked to provide information on the stage reached in

the preparation of the legislation, and to notify the measure, with adequate notice, in order to receive and take into account the comments and concerns of the affected Members.

3.10. The representative of Trinidad and Tobago stated that the notice was currently not in force and that the details were being finalized, including the scope of the ban. The proposed measure would be notified to the WTO via the enquiry point once details were finalized. She said that the notification would include a proposed date of entry into force and that her delegation intended to

provide trading partners with the necessary information once it was confirmed to enable them to adapt to the new legislation.

3 For previous statements follow the thread under IMS ID 574 (under dates raised and references).

Page 4: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 4 -

3.3.1.2 European Union - Draft Commission Regulation laying down eco-design requirements for electronic displays pursuant to Directive 2009/125/EC of the European Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes)" G/TBT/N/EU/609 (IMS ID 5754)

3.11. The representatives of China and the United States raised concerns with the EU's Draft

Commission Regulation laying down eco-design requirements for electronic displays pursuant to Directive 2009/125/EC of the European Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes). The full statements are contained in G/TBT/W/616 and G/TBT/W/606, respectively.

3.12. The representative of Japan expressed appreciation for the EU's policy to improve the energy

and resource efficiency of energy-related products. However, having watched closely the impact of the eco-design requirements of electronic displays on domestic industries, Japan was deeply concerned that the latest draft regulation contained significant changes not present in the draft regulation notified to the TBT Committee in October 2018. Of particular concern was that the introduction of a ban of all halogenated flame retardants (HFRs) and the requirements on "Spare Part Availability and Delivery Time" to the latest draft which he said greatly impacted Japanese industries. His delegation requested that the EU notify the revised draft and consider opening a new

comment period when there were significant changes from a notified draft regulation. He said that the new eco-design regulations would have a major impact on trade in the electric and electronics products and therefore requested that the EU ensure that the regulations be established in a transparent process and not pose unnecessary trade barriers.

3.13. The representative of the European Union noted that on 9 October 2018 the EU had submitted the notification in question allowing for a 60-day comment period. Comments had been received from Japan, Korea and the US. The Ecodesign Regulatory Committee (ERC) had met on 18 December

to discuss and vote on the Commission proposal. He said that in the context of comitology procedures set out in Regulation (EU) 182/2011 ("Comitology regulation"), committee members representing member States had the opportunity to suggest amendments to the Commission draft and that the chair may present amended versions of Commission draft implementing acts, to endeavour to find solutions commanding the widest possible support within the committee. The Commission had done so on a number of ecodesign measures currently under discussion, including the partial restriction

on the use of halogenated flame retardants. The text, as voted, was now in the scrutiny period. He stated that the regulation would repeal the previous Ecodesign legislation on televisions and TV monitors in force since 2010 and would extend the scope to other electronic displays, such as computer monitors. The review included, on top of energy efficiency requirements updated to the technology evolution, new "circular economy" requirements for increasing durability and improving reparability and for improving the efficiency of the recycling process and the yields of recoverable materials.

3.3.2 China - Cosmetics Supervision and Administration Regulation (Draft)

G/TBT/N/CHN/1310 (IMS ID 5765)

3.14. The representative of Japan appreciated the classification with respect to new ingredient application procedures in the draft regulation but noted that other concerns had not been improved or clarified. First, the scope of disclosure for new ingredients in article 9 should explicitly exclude confidential company information. Second, article 15 regarding online publication of the scientific basis of efficiency claims should be reconsidered, because efficacy evaluation materials contain

confidential company information. In this context, she further requested that the text explicitly accept testing data from laboratories outside China or internal to the company. Third, article 38's requirement of consistency between Chinese labels and original labels should be reconsidered, because the original labels were designed to comply with, often different, country of origin regulations. Fourth, she noted that whereas the draft regulation noted the responsibility for quality and safety of multiple stakeholders, such as "cosmetics producers and operators" and "cosmetics

registrants or filers", Japan requested that article 6 only require one responsible legal or natural person inside China and that label requirements regarding producers in article 39 should be

4 For previous statements follow the thread under IMS ID 575 (under dates raised and references). 5 For previous statements follow the thread under IMS ID 576 (under dates raised and references).

Page 5: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 5 -

removed. Fifth, she noted that China's current practice of requiring animal testing documentation only for imported products amounted to discriminatory treatment according to the WTO rules, and that Japan requested for article 13 to reflect equal treatment of imported products. Lastly, Japan requested China to provide an adequate grace period of at least one year for implementation to avoid confusion in the market.

3.15. The representative of the Republic of Korea expressed concern over article 15 of the draft

regulation requiring publication of evidence supporting efficacy claims on a website designated by the National Medical Products Administration (NMPA). Recalling Article 5.2.4 of the TBT Agreement, he stated that it was inappropriate to demand public access to evidence which may contain confidential business information and that the provision should therefore be amended to allow for direct submission of evidence to NMPA where necessary. In addition, he asked that article 38 be amended to deem over-labels in Chinese that were accurate and complete in content and complied

with the Chinese cosmetics labelling requirements be sufficient. He expressed concern that requiring

over-labels to be consistent with the original labels would be trade-restrictive and impose additional administrative burdens. Lastly, Korea asked China to provide enough transitional period and asked for other relevant information including the date of the draft regulation's entry into force.

3.16. The representative of the United States requested China, first, to close the gap on timing differences for market authorization for imported products versus domestic products. Second, she asked China to use international standards, including from ISO, ASTM International, and NSF

International, and to consider ISO 22716:2007, "Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices," as well as ingredient, product safety and claims assessment. She noted that the draft regulation did not incorporate these standards by reference or demonstrated their consideration. Third, she asked China to consider the principles and recommendations developed by the International Cooperation on Cosmetics Regulation (ICCR). Fourth, she requested more specific information on what product filing requirements and other administrative measures may demand the disclosure of CBI, including ingredient filings, product

efficacy claims, and adverse events reporting. She noted that the provisions in the draft regulation

indicated governmental publication of this information, whereas regulators in the United States, European Union, and other markets generally did not require such full disclosure—only requesting additional information should there be an adverse event which companies were then required to provide, usually within 72 hours, via their authorized in-country representative. Lastly, she thanked China for notification G/TBT/N/CHN/1311 of a draft measure providing information on testing and

filing requirements for both imported and domestically produced cosmetics.

3.17. The representative of the European Union welcomed the draft regulation being based on the principles of modern cosmetics legislation and aligning with global regulatory trends. She noted that the measure allowed China to address some key concerns and barriers arising from the current legislation that Members had raised repeatedly in TBT discussions. These concerns included the lack of approval of new cosmetic ingredients, the discriminatory management of imported versus domestic non-special products, a potentially mandatory Chinese packaging brought by a ban of over-

stickering of original labelling, as well as the mandatory requirement to carry out unnecessary animal tests on finished cosmetic products imported to China. She noted that the draft regulation aimed to

address these issues directly or at least provided the framework to address them in ensuing implementing measures. In this context, the EU noted the importance of implementing measures to follow the draft regulation's principles and intentions to ensure high compatibility with trading partners, high levels of consumer protection, and facilitation of industry development and international trade. Lastly, the representative asked China to explain the state of play of the new

draft Cosmetics Supervision and Administration Regulation and to indicate the planned timeframe for its adoption.

3.18. The representative of China stated that the purpose of the draft regulation, which had been notified, was to respond to developments in China's cosmetics industry. She expressed the need to study Members' concerns and respond at a later time.

Page 6: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 6 -

3.3.3 Republic of Korea - Warning statement and graphic health warnings on alcoholic beverages (IMS ID 5776)

3.19. The representative of the United States expressed full support for the objective of managing the public health challenges related to drunk driving. However, her delegation was concerned by the lack of transparency in the development of the proposed amendments to Korea's Public Health Promotion Act. It was also noted that many aspects of the measure were currently unclear, including

the timeline for implementation and the technical requirements for the new labels which could result in an unnecessary disruption to trade in US alcohol beverage products to Korea. In December 2018, the US had requested via the TBT Enquiry Point that Korea notify the revisions under consideration to its Public Health Promotion Act, including the details of its new graphic warning label requirements for beverage alcohol. She noted that Korea had not notified the amended measure and asked Korea to commit to doing so before adoption.

3.20. The representative of the Republic of Korea reported that the preparation of the notification was in process and committed to keep consulting with interested parties on the issue in a transparent manner.

3.3.4 Uruguay – Labelling of Packaged Food (IMS ID 5787)

3.21. The representative of Costa Rica raised concerns with Uruguay's regulation on the labelling of packaged food. The full statement is contained in G/TBT/W/613.

3.22. The representative of the United States thanked Uruguay for their bilateral meeting and noted

their support of Uruguay's objectives of reducing diet related non-communicable diseases. She stated that the final decree as notified may, however, not be based on robust scientific evidence, be more trade restrictive than necessary to achieve a legitimate objective, did not appear to consider the relevant international standards, and may contribute to consumer confusion. She further asked whether positive health claims would be allowed for foods such as yogurts, cereals, or oatmeal which

were required to carry the warning label but may also contain other nutrients, be fortified, or make other positive contributions to an overall diet. In addition, she noted that the United States had not

received a response to its 2017 comments on the draft decree and asked whether Uruguay had reviewed evidence-based international standards to determine if they would fulfil Uruguay's public health objectives. Although the US had listed international standards in communication with Uruguay, the original draft document did not mention Codex standards being utilized or evaluated, while the final decree only mentioned the Pan American Health Organization's Nutrient Profile Model. The United States further asked whether Uruguay had considered that the required black and white

octagonal "stop sign" symbols and the new requirement that they contain the initials MPH in addition to the statement that the product was in "excess of" a specified nutrient may cause consumers to avoid products that could be part of a healthy diet. She asked whether studies in Uruguay had demonstrated that this interpretive approach was more effective than presenting nutrient and calorie information on labels based on serving size portions of the product, and whether Uruguay had evaluated any alternative labelling schemes, or a voluntary approach.

3.23. The representative of the European Union noted interest in this regulation and asked for a

written reply to the comments the delegation would send.

3.24. The representative of Guatemala reiterated concerns over the creation of divergent labelling of packaged food without taking into account the Codex Alimentarius. She noted that this worked in favour of large firms with the capacity to create labels for different markets and consequently discriminated against MSMSEs and SMEs. While recognizing Members' legitimate objectives in this domain, she highlighted that technical regulations should not be any more restrictive than necessary.

3.25. The representative of Uruguay responded to the concerns raised. The statement is contained

in G/TBT/W/614.

6 For previous statements follow the thread under IMS ID 577 (under dates raised and references). 7 For previous statements follow the thread under IMS ID 578 (under dates raised and references).

Page 7: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 7 -

3.3.5 European Union - Chlorothalonil (pesticide active substance) G/TBT/N/EU/625 (IMS ID 5798)

3.26. The representatives of the United States and Colombia raised concerns with the EU's measure on chlorothalonil. The full statements are contained in G/TBT/W/607 and G/TBT/W/600, respectively.

3.27. The representative of Guatemala expressed concern with respect to the measure notified in

G/TBT/N/EU/625 of 4 December 2018, with respect to the non-renewal of the approval of the active substance chlorothalonil, a substance generally used by some agricultural producers as a fungicide to control certain pests. Her delegation reiterated its belief that the EU should take a risk-assessment approach based on sufficient scientific evidence in determining control levels, particularly those established in the Codex Alimentarius. Guatemala considered that changes to agricultural practice required a more extensive process and that it was important to be adaptable in seeking alternatives

as regards the use of pesticides. She pointed out that as these processes were lengthy, transitional periods should be set accordingly.

3.28. Guatemala associated itself with Colombia's request to maintain the approval of chlorothalonil in the EU, and with the concerns previously expressed by other Members. She also called upon the EU to offer solutions and alternatives for tropical countries in respect of their ability to adapt in this area. Referring to the indication in the EU's notification that the maximum residue levels (MRLs) for pesticides containing chlorothalonil may be revised in the future, clarification and information about

the work plan envisaged was requested, as well as the arguments being put forward in that regard.

3.29. The representative of Brazil shared Colombia's concerns, in particular the fact that the EU's decision was founded only on a hazard-based approach, without a proper risk analysis. The non-renewal of approval for chlorothalonil by the EU did not take into consideration that it was currently authorized in 109 countries, and that the MRLs allowed by Codex could reach up to 70 mg/kg, depending on the product. In this context, he reiterated Brazil's concerns with the fact that some

analyses conducted by the European Food Safety Agency (EFSA), whose results on the genotoxicity

of substances were founded on a hazard-based approach, had led to the non-renewal of certificates and subsequently to the reduction of MRLs. The case of chlorothalonil, he said, had a negative impact on Brazil's trade of agricultural products, such as banana, coffee, citrus fruits, papaya, watermelon, among others, which used this substance for pest control. He recalled that for all those commodities, Brazil adopted MRLs below those established by Codex, in line with concerns related to consumer safety.

3.30. Finally, Brazil reiterated its systemic concern with the fact that issues relating to the non-renewal of agricultural pesticides were being dealt firstly in the TBT Committee. He said that in many cases the communication of non-renewal of approval of important substances for trade of agricultural commodities was notified in the TBT Committee as an announcement of the future reduction of MRLs in the SPS Committee. In this context, Brazil asked the EU about the eventual next steps regarding the possible reduction of MRLs for chlorothalonil and that this be notified to the SPS Committee as soon as possible.

3.31. The representative of Panama reiterated his delegation's continuing concern, already expressed in the TBT Committee as well as the SPS Committee, on measures being taken by the EU which appeared to go beyond Codex Alimentarius scientific evidence.

3.32. The representative of Paraguay expressed concern with the measure as in Paraguay, chlorothalonil was classed as a low-risk pesticide and sold freely. It was used for several key products exported from Paraguay, such as corn, wheat, rice and soya and whilst not the main input of phytosanitary products for the pest control of such crops, it was considered as a component in the

rotation of these products to address handling shortfalls and prevent resistance to other active substances. Her delegation deemed that the categorization of chlorothalonil as carcinogenic, carried out by the EFSA, was based on inconclusive claims. The proposal to eliminate the use of this active substance had once again been based on a hazard assessment rather than a consumer risk assessment, and, once again, did not comply with relevant international standards. It was felt that

8 For previous statements follow the thread under IMS ID 579 (under dates raised and references).

Page 8: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 8 -

rather than providing a genuine solution or fulfilling the objective of health protection, this situation would result in unnecessary barriers to trade.

3.33. Paraguay also expressed concern with the pattern of action taken by the EU, starting with the prohibition of the marketing of a substance and then moving to the amendment of the MRLs for that substance. Her delegation believed that such amendments established levels that were equivalent to a prohibition of the use of the substance and did not ensure import tolerances. The EU was urged

to comply with the international commitments that it had undertaken in the WTO, and to carry out risk assessments rather than hazard assessments when making this type of decision.

3.34. The representative of Canada thanked Colombia for bringing the issue to the attention of the Committee as chlorothalonil was registered for use in field and orchard crops in Canada. She said that a growing number of active substances were not being renewed in the EU due to incomplete or insufficient information to complete a risk assessment and excluded health and environmental

concerns. Canada considered this a worrisome trend that may affect agriculture and food imports in the EU given the lack of clarity on how import tolerances would be established following a non-renewal decision due to lack of such information. Her delegation encouraged the EU to indicate what information was needed to complete and conclude its risk assessment.

3.35. The representative of Ecuador was aware that the decision currently only mentioned the placing of the substance on the market and not of an MRL for this product. Her delegation nevertheless expressed concern over the fact that specific measures could be taken regarding the

MRLs and that such measures could be very restrictive. In Ecuador, she said, active chlorothalonil registers were kept for several agricultural products, but the substance was especially used as a technological tool to help control Black Sigatoka in bananas. The EU was requested to take into consideration the fact that Ecuador's banana exports accounted for 2% of overall GDP and approximately 35% of agricultural GDP. According to registers of the Ministry of Agriculture and Livestock (MAG), about 162,236 hectares had been cultivated with bananas, representing 4,473 banana producers (small (3,480), medium-size (800) and large (193)). Ecuador therefore

urged that, before a final decision was taken on implementing the measure and another on possible assessment of the MRLs, the European Commission consider all existing data, as well as comments submitted to it, with due regard for the implications on the food-producing sector of developing countries.

3.36. The representative of Costa Rica raised concerns with the EU's measure on chlorothalonil. The full statement is contained in G/TBT/W/612.

3.37. The representative of Honduras expresses its trade interest in the issue and asked the EU for more information on the criteria used for the implementation of the measure.

3.38. The representative of the European Union responded to the concerns raised. The full statement is contained in G/TBT/W/625.

3.3.6 European Union - Transitional periods for MRLs and international consultations (IMS ID 5809)

3.39. The representative of Colombia raised concerns with the EU's transitional periods for MRLs

and international consultations. The full statement is contained in G/TBT/W/601.

3.40. The representative of Guatemala reiterated the importance of using a risk-assessment approach as a frame of reference, to avoid the creation of measures generating unnecessary barriers, and the need for such measures to be based on scientific evidence. She recalled that her delegation had said repeatedly that products from tropical countries, where climatic conditions were different, and farmers must contend with challenges not faced by European producers, were placed at a disadvantage by measures of this kind. This was consistent with the provisions of the TBT

Agreement that such measures should not be more trade-restrictive than necessary. She said that producers and exporters were trying to comply with the established conditions to continue responding to market demand and fulfilling contractual obligations. Periods allowed, however, were

short, making it harder to find alternatives. Guatemala supported the requests made to create a

9 For previous statements follow the thread under IMS ID 580 (under dates raised and references).

Page 9: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 9 -

space in the WTO for technical discussion and evaluation of the transition periods allowed for the implementation of changes to regulations and proposed an extension of at least six additional months for the entry into force of the provisions concerning buprofezin.

3.41. The representative of the United States associated itself with and expressed support for the concerns of Colombia about the EU system.

3.42. The representative of Paraguay was concerned that the length of the transition period granted

for the implementation of amended MRLs was not sufficient for the competent domestic institutions to revise and potentially amend national regulations, and for producers to adapt to the new requirements established by the importing party. It is also worrying that the concerns raised, and comments made during international consultations had not been taken into account by the European authorities when adopting these amendments.

3.43. The representative of Brazil expressed support for the concerns raised by Colombia. His

delegation emphasised the importance of Article 2.12 of the TBT Agreement, as relates to the provision of a reasonable interval between the publication of technical regulations and their entry into force, except in cases of urgent problems of safety, health, environmental protection or national security. Also highlighted was the WTO Ministerial Decision of November 2001, on "Implementation-Related Issues and Concerns", which said that a "reasonable interval" should be understood to normally mean a period of not less than six months, except when this would be ineffective in fulfilling the legitimate objectives pursued. His delegation believed that it was important to guarantee

adequate intervals of transition, especially for those cases in which the scientific opinions of the European Food Safety Authority on the toxicity of substances were "inconclusive" or only indicated a "suspected risk". He reiterated Brazil's concern that in some of these cases, also founded on a hazard-based approach, the EU was deciding to reduce the MRLs of certain substances.

3.44. The representative of Ecuador shared Colombia's concern that these periods were too short and did not give time to find alternatives which could lead to a blockage of exports to this important

market. She added that it would have a deep impact on producers, many of whom were low-income

SMEs, without access to other sources of income.

3.45. The representative of Costa Rica joined Colombia in requesting an extension of the time-limit for compliance with the new tolerance established for buprofezin, due to its major impact on exports of Costa Rican bananas to the European market. His delegation was greatly concerned by the European Union's revision of the tolerances for different substances used in agricultural production. He echoed Colombia in explaining that it was impossible for agricultural production to adjust to new

requirements and tolerances within six months, when the registration alone of new molecules must undergo a full evaluation lasting much longer than this time-limit. Costa Rica urged the EU to establish a dialogue with the countries exporting agricultural products that were seriously affected by the amendments made unilaterally to MRLs by a trading partner. It was hoped that these studies, analyses and decisions be adopted multilaterally in the framework of the Codex Alimentarius, in line with the spirit of WTO rules.

3.46. The representative of Panama joined other Members in calling for dialogue on the new MRL

levels that had been assessed for different chlorates and other substances, as well as an extension of the deadline to allow less trade-restrictive alternatives to be found.

3.47. The representative of the European Union stated that as a matter of principle, the EU considered concerns on the setting of MRLs for pesticides – and any details regarding their implementation – to be a matter for discussion at the SPS Committee, rather than at the TBT Committee. He said that the EU fulfilled all its obligations under both the TBT and the SPS Agreements, including notifying its trading partners of planned measures falling within the scope of

either of the agreements. Information and comments received in response to these notifications were duly considered and taken into account before a final decision was taken. This was clearly and extensively explained in each EU reply to those trading partners that submitted comments.

3.48. As regards possible transitional periods when MRLs were lowered, the EU informed the

Committee about two key provisions of such measures. First, following the formal adoption, publication and entry into force of an act lowering MRLs, a deferred date of application was set. The

date of application was the date from which the new/lower MRLs were effectively enforced. The

Page 10: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 10 -

length of the deferral was six months after entry into force, in the vast majority of cases. This deferral of the application date permits, inter alia, third countries and food business operators to prepare to meet the new requirements resulting from the modification of the MRLs. Second, products produced in the EU or imported into the EU before the aforementioned application date may continue to benefit from the old/higher MRLs and remain on the market, if information showed that a high level of consumer protection was maintained. This was regularly not the case where MRLs were

lowered because the safety of consumers could not be demonstrated.

3.3.7 Jamaica - Regulations Banning Single-Use Plastic Products (IMS ID 58110)

3.49. The representative of the Dominican Republic raised concerns with the Jamaica's measure on the prohibition of plastic packaging materials. The full statement is contained in G/TBT/W/611.

3.50. The representative of Jamaica advised the Committee that the observations raised by the

Dominican Republic had been duly noted in capital and that her delegation would revert on the issue.

3.3.8 Republic of Korea - Regulation on Energy Efficiency Management Equipment G/TBT/N/KOR/772 (IMS ID 58211)

3.51. The representative of China raised concern that Korea had notified this regulation to the WTO on 28 May 2018, with a proposed enforcement date of 1 July 2018, only providing Members with a one-month transitional period. Not only was this period less than the six months recommended by the TBT Committee, but also less than the transitional period provided for domestic enterprises. According to relevant provisions of TBT Agreement, China suggested that Korea provide national

treatment for other Members and extend the transition period to six months. The regulation established different cleaning ratio requirements for pulsator washing machines and roller washing machines under the cold-water washing mode; in light of this, his delegation also suggested that Korea establishes technical requirements based on product performance and uses the same requirement for both kinds of washing machine.

3.52. The representative of the Republic of Korea committed to respond to China's concerns after consulting with relevant authorities, and to keep consulting with interested parties on the issue in a

transparent manner.

3.3.9 Kingdom of Saudi Arabia – Technical Regulation for plastic products OXO – biodegradable (IMS ID 58312)

3.53. The representative of the European Union raised concerns with the Kingdom of Saudi Arabia's technical regulation for oxo-degradable plastic products. The full statement is contained in G/TBT/W/626.

3.54. The representative of the United States expressed support for the EU in raising this concern.

3.55. The representative of the Kingdom of Saudi Arabia announced that it would delay the implementation of stage 2 and 3 of this technical regulation until September 2019. In the meantime, he reported, a national study had been launched to investigate the claim of the adverse impact of the oxo-degradable on the environment, taking into account climatic conditions in Saudi Arabia. His delegation requested the EU for any recent research on the matter and flagged that a bilateral meeting would be held with the EU to discuss the issue.

10 For previous statements follow the thread under IMS ID 581 (under dates raised and references). 11 For previous statements follow the thread under IMS ID 582 (under dates raised and references). 12 For previous statements follow the thread under IMS ID 583 (under dates raised and references).

Page 11: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 11 -

3.4 Previously raised concerns

3.4.1 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.3 (IMS ID 32813)

3.56. The representative of the European Union raised concerns with Indonesia's recent amendment to Regulation of Minister of Industry No. 24/2013 on the mandatory implementation of the Indonesia

national standard (SNI) for Toys introduced by Regulation of the Minister of Industry on 29 November 2018 and notified on 30 November 2018 (G/TBT/N/IDN/64/Add.3). The full statement is contained in G/TBT/W/627.

3.57. The representative of the United States noted that dialogue on Indonesia's toy standard dated back to 2012. It was her delegation's understanding that Indonesia's Ministry of Industry

(MOI) had been working with stakeholders to address outstanding issues and it was hoped that this

would lead to resolution of long-standing concerns. It was also the understanding of the US that Indonesia had revised MOI Regulation 24/2013 "on the Mandatory Implementation of Indonesian National Standard (SNI) for Toys", through issuance of MOI Regulation 29/2018, and had notified it to the WTO. It was noted, however, that the notification had come after the regulation had been issued and in force and therefore requested an update on the timeline for issuance of implementing measures to the regulation.

3.58. The US reiterated previously raised concerns about conformity assessment, noting that the

requirement for a Mutual Recognition Agreement (MRA) with Komite Akreditasi Nasional (KAN) in order to recognize labs for the testing of toys outside Indonesia remained in Regulation 29/2018. Her delegation urged Indonesia to accept any ILAC-accredited laboratory on a permanent basis, without requiring a government-to-government MRA. Indonesia was requested to draft implementing measures to address Members' concerns, including easing strict conformity assessment procedures for imported products, eliminating domestic testing requirements not

acknowledging ILAC-accredited laboratories, and changing the incorporation by reference from the

old SNI 7617:2010, rather than the new SNI 7617:2013, which, in the view of the US, was in greater alignment with international standards for formaldehyde testing.

3.59. The representative of Japan expressed support for the EU's position and welcomed the fact that Indonesia had revised its toy regulation, responding to the requests from the EU, Japan and other Members. She expressed particular appreciation for the introduction of a new scheme incorporating a quality management system in the production process as an option for toy

certification procedures. In order to avoid unnecessary technical barriers to the toy trade in Indonesia, Japan considered the implementation of rules, such as procedures for factory audit, essential to making this new toy certification scheme useful. In this regard, Japan encouraged Indonesia to make continued efforts to develop implementation guidelines consistent with WTO rules. Her delegation remained concerned that the revised regulation still contained unnecessary trade-restrictive measures such as the testing requirement for "each-and-every import shipment", the existing certification scheme, and the overseas laboratory accreditation requirement. Indonesia

was asked to revise these discriminatory requirements to be consistent with its WTO TBT obligations.

3.60. The representative of Canada supported the interventions made by other delegations and requested the use of non-discriminatory requirements that were the least trade restrictive as possible and to permit the use of foreign accreditation bodies. Canadian stakeholders had expressed concerns regarding the revised safety requirements of the measure, namely that domestic products continued to enjoy a more favourable testing frequency, that certification was permitted in only a limited number of Indonesian labs and that the requirements were overly burdensome. At the

November 2018 Committee meeting Indonesia had noted that a review of the requirements was nearing completion and that the new sampling method would be more flexible. Indonesia was asked to update the Committee on how the review had met this goal.

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

Page 12: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 12 -

3.61. The representative of Indonesia informed Members that the revision process had finally concluded by the issuance of Regulation of Minister of Industry Number 29/2018 and that the drafting of implementing guidelines thereto was currently in process.

3.4.2 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 34514)

3.62. The representative of Argentina raised concerns with the EU's regulations on protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products. The full statement is contained in G/TBT/W/605.

3.63. The representative of the United States reiterated previously raised concerns regarding the

EU's delay in resolving this specific trade concern.15

3.64. The representative of Brazil supported the concerns raised by Argentina and the US. As stated in previous meetings, the terms contained in the regulation also affected Brazilian wine producers, and the fact that the EU was still analysing this case after over a decade showed that this measure was a non-tariff barrier and does not pursue any legitimate objective under the TBT Agreement. Brazil asked if the EU could share any updated information and the estimated time-frame related to the use of regulated terms for wines exported to the EU in Regulation (EC) No. 607/2009, Council

Regulation (EC) No 479/2008 and revised regulations notified under G/TBT/N/EU/570 and G/TBT/N/EU/571.

3.65. The representative of the European Union recalled that the EU had undertaken a revision of its legislation on wine, including on traditional terms (see G/TBT/N/EU/571), as explained in previous TBT Committee meetings. This process resulted in the adoption of Commission Implementing

Regulation (EU) 2019/34 of 17 October 2018 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (as regards applications for protection

of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, amendments to product specifications, the register of protected names, cancellation of protection and use of symbols), and of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (as regards an appropriate system of checks). She said the European Commission will now undertake the examination of pending applications for traditional terms, and that no precise timeline can be provided at this stage.

3.4.3 European Union — Quality Schemes for Agricultural Products and Foodstuffs, G/TBT/N/EU/139, G/TBT/N/EU/139/Add.1 and G/TBT/N/EU/593 (IMS ID 51216)

3.66. The representatives of Argentina and the United States raised concerns with the European Union's Quality Schemes for Agricultural Products and Foodstuffs. The full statements are contained

in G/TBT/W/604 and G/TBT/W/608, respectively.

3.67. The representative of Uruguay referred to previous statements made in both the TBT Committee17 and in the Council for Trade in Goods. He said that his delegation continued to have

concerns regarding the protection and registration of the term "danbo" as a protected geographical indication by the European Union. "Danbo", it was stressed, was a generic term and was therefore not eligible for registration as a geographical indication and could not have any limitations placed on its use. Indeed, a reading of point 7 of the standard CODEX STAN 264, adopted in 1966 and updated several times with the participation of the European Union and its member States, showed that Members recognized "danbo" as a generic term used for referring to a good that could be produced in various locations as long as it satisfied the requirements set forth in the standard. The

representative of Uruguay regretted the position taken by the European Union that the matter concerned intellectual property and therefore could not be addressed in the TBT Committee. He reminded the EU delegation that the regulation granting these rights had been correctly notified by

14 For previous statements follow the thread under IMS ID 345 (under dates raised and references). 15 G/TBT/M/76, para. 3.55. 16 For previous statements follow the thread under IMS ID 512 (under dates raised and references). 17 G/TBT/M/76, para. 3.127; and G/TBT/M/75, para. 4.140 and G/TBT/W/543.

Page 13: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 13 -

the European Union itself to the TBT Committee on 18 November 2013 in document G/TBT/N/EU/139 precisely because it had TBT-related implications for matters such as labelling and relevant international standards. Therefore, Uruguay urged the European Union to reconsider its measure to avoid unnecessary restrictions to trade, while duly taking into account the international standards established by the Codex.

3.68. The representative of New Zealand remained concerned that the European Commission had

chosen to register the term Danbo, despite having previously agreed to a Codex standard in which the European Commission and Denmark both acknowledged "the country of origin statement preserves its generic nature". Such actions would negatively affect producers outside Denmark who had invested with the legitimate expectations that they could use the standard. These actions showed disregard for the integrity of the international standards setting system that promoted reliability and consistency in international trade rules - which New Zealand expected the EU to

support.

The representative of the European Union repeated the response provided in previous TBT Committee meetings.18

3.4.4 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; G/TBT/N/TPKM/346, G/TBT/N/TPKM/347 and G/TBT/N/TPKM/348 (IMS ID 51119)

3.70. The representative of the European Union reiterated previously raised concerns.20

3.71. The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu stated that his delegation had notified three draft implementation regulations to the WTO on 7 January 2019 (G/TBT/N/TPKM/346, 347 and 348) that explained the administrative processes for the management of imported organic agricultural products. Chinese Taipei welcomed comments from the EU and would maintain close contact to address those concerns. Furthermore, a bilateral

working level video conference had been held on 14 December 2018 including discussions on the procedures for accrediting certification bodies in the EU. Certification bodies in the EU were welcome

to apply for recognition upon the adoption of the notified regulations. Chinese Taipei had high expectations to reach consensus on bilateral organic equivalence with the EU as it was the most convenient way to export organic products to Chinese Taipei. He concluded that Chinese Taipei already extended the transition period for Members and urged the EU to start negotiating the bilateral organic equivalence agreement.

3.4.5 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 50921)

3.72. The representative of the European Union again referred to concerns raised in previous meetings. In light of the on-going reform of the standardization system in China, she asked when the new consolidated standards would be finalized, notified to the WTO, and when they would enter

into force. To help facilitate implementation, the EU needed to know whether the announced consolidation of the standards would replace the previous ones contained in G/TBT/N/CHN/1094-1095-1096, and whether the outcome would be a development of one new standard replacing the

previous ones. The EU also needed to receive information concerning the scope of consolidation and whether it would concern the same furniture product groups as the previous standards or would it be either broader or cover fewer furniture product groups. The EU also asked what limits of harmful substances would be covered by the consolidation. She asked if China considered it timely and relevant to consider exploring the possible use of ISO standards, either those existing or those still in development. She asked for clarification on which body would be responsible for the development of the new standard and if it was to be the body dealing with environmental standards. The EU

remained open to hold technical discussions in Brussels on issues relating to furniture standards, as

18 G/TBT/M/76, para. 3.128; and G/TBT/M/75, para. 4.142 and G/TBT/W/501. 19 For previous statements follow the thread under IMS ID 511 (under dates raised and references). 20 G/TBT/M/76, para. 3.129; G/TBT/M/75, para. 4.145–4.146; G/TBT/M/74, para. 2.169 and

G/TBT/W/502. 21 For previous statements follow the thread under IMS ID 509 (under dates raised and references).

Page 14: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 14 -

originally proposed by China in June 2017, and requested that China designate its contact point for the organization of such a meeting.

3.73. The representative of China informed the Committee that in 2016 under the six measures of "Deepening the Reform Programme of Standardization work", China had simplified and integrated all the mandatory standards, including those in the furniture industry. On 14 January 2017, the China National Standardization Administration Committee published the "Notification of the issuance

of conclusion of the simplifying and integrating of Chinese mandatory standards" (No.4 document of SAC in 2017). In this conclusion, the above three standards needed to be integrated before they could be released. As a result, these three standards had not yet been published and implemented. The relevant requirements of "Notification of completing the follow-up work for the conclusion of the simplifying and integrating of mandatory standards" (No. 464 document of the Department of Science and Technology, Ministry of Industry and Information Technology in 2017), the standards

development work was ongoing, and the mandatory standards project proposal "Limit of hazardous

substances in furniture" had been raised and published online in accordance with the relevant procedures. It was now in the process of soliciting public opinion.

3.4.6 European Union — Titanium dioxide: Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, G/TBT/N/EU/629 Part 2 (IMS ID 53922)

3.74. The representatives of the United States and Mexico raised concerns with the European Union's Titanium dioxide regulation. The full statements are contained in G/TBT/W/609 and

G/TBT/W/619, respectively.

3.75. The representative of Japan raised concerns with the provisions for titanium dioxide and mixtures containing titanium dioxide contained in the EU's 14th adaptation to technical progress (ATP) proposal to CLP regulation. Japan asked the EU to ensure that the regulation would not be more trade-restrictive than necessary.

3.76. The representative of Canada noted the concerns raised by other delegations about the EU's proposed changes to the regulations and voiced particular concern about the potential impact on

trade in products containing titanium dioxide or cobalt and the process that the EU had followed to arrive at the proposed amendments to the CLP Regulations. His delegation considered that changing the classification of titanium dioxide and cobalt under the CLP Regulations could result in stricter requirements under other regulations, beyond simple labelling requirements, which could in turn have a significant impact on trade from Canada. Cobalt, for instance, was present in small amounts in nickel. Canada exported $1.1 billion in various types of nickel to the EU in 2017, representing

29% of Canada's total nickel exports. As a result, any fluctuations in the EU's demand for nickel or downstream products, such as stainless steel, would have very significant implications for Canada's nickel industry.

3.77. The EU was asked to explain the next steps in its process to consider the proposed changes, including any relevant timelines. In addition, an explanation of how products containing titanium dioxide or cobalt would be treated under the entire EU regulatory framework as a result of the

proposal was requested. Furthermore, Canada suggested that the EU conduct a Better Regulation

Impact Assessment in order to ascertain the full range of economic and health and safety impacts that may result from the proposal.

3.78. The representative of Australia recognized the EU's right to regulate for public and occupational health and safety, also recognizing that appropriate classification and labelling for hazardous substances and mixtures could address legitimate public and occupational health concerns. His delegation raised the possible implications of classification of Titanium Dioxide (TiO2) as a carcinogen as, according to Australia, it may create unnecessary obstacles to international trade

for TiO2 and products containing TiO2. In this context, Australia suggested that alternative regulatory measures were available to address the EU's concerns that would more directly address the potential health hazards of TiO2 without affecting trade.

3.79. The Australian industrial chemicals regulator, the National Industrial Chemicals Notification

and Assessment Scheme (NICNAS) had undertaken recent assessments on the risks of TiO2

22 For previous statements follow the thread under IMS ID 539 (under dates raised and references).

Page 15: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 15 -

(excluding nano particles of TiO2), and found that: (i) exposure to TiO2 in a finished product through dermal, inhalation and oral routes presents limited risks to human health; and that (ii) appropriate work health and safety controls were adequate to protect public and workers' health and safety in relation to TiO2 inhalation exposure. The NICNAS information sheet on nanoparticles of TiO2 stated that there was some evidence that breathing in large quantities of TiO2 nanoparticles over a long period of time may cause toxic effects due to impairment of normal lung clearance mechanisms but

the studies available (up to 2012) did not provide sufficient evidence to conclude that TiO2 caused lung tumours in humans.

3.80. Australia suggested that if a classification was proposed for TiO2, it should be limited to nanoparticles of TiO2 (<100 nm in size) and only through the inhalation route. He added that there should be clear evidence that the carcinogenicity was from TiO2 and not from the insoluble nature of TiO2 nanoparticles causing lung overloading. TiO2 was a premium pigment used in the

manufacture of a wide range of products, most commonly paint and coatings and it was stressed

that as per TBT Agreement commitments the EU must ensure that any regulation to address concerns about the possible carcinogenicity of TiO2 when inhaled was no more trade restrictive than necessary and did not unduly impact trade in goods containing TiO2.

3.81. The representative of the European Union responded to the concerns raised. The full statement is contained in G/TBT/W/628.

3.4.7 Israel — Addendum to the Pharmacist Regulations (Cosmetics 5778-2018)

G/TBT/N/ISR/709/Add.2 (IMS ID 55223)

3.82. The representative of the European Union raised concerns with Israel's Addendum to the Pharmacist Regulations (Cosmetics 5778-2018). The full statement is contained in G/TBT/W/629.

3.83. The representative of the Republic of Korea expressed its continued interest in the Addendum to the Pharmacists Regulations notified by Israel on 23 January 2018, and voiced concern that the

requirement for GMP certification from a health authority for cosmetics was not in line with international standards and would cause unnecessary obstacles to international trade. Also, it was

considered that requiring the submission of quarterly reports for every single product would impose substantial administrative burdens on industries. He enquired when the draft would be finalized and urged Israel to notify the revised regulations reflecting Members' comments to the TBT Committee.

3.84. The representative of Israel stated that the process to align its cosmetics regulations with international best practice had started in 2013. The most recent notification on this measure had been made on 23 January 2018 when Israel notified its amended regulations to the TBT Committee

in G/TBT/N/ISR/709/Add.2 to which the EU had provided comments on 14 February 2018. Israel had responded in writing to these comments on 26 February 2019 whilst at the same time providing Korea with a written response to their concerns raised in the Committee. He said that with regards to the notion of Responsible Person, the origin of the requirement that a responsible representative must not be a corporation, was embodied in Article 55.A.6 of the Pharmacists' Order (New Version), 5741-1981 (hereafter – "The Order") and not in the Pharmacists' Regulations (Cosmetics), 5779-

2018 (hereafter "The Regulations"). Similarly, the source of the requirement for a report by the

responsible representative lay in the main legislation. In view of the normative standing of The Regulations it was not possible to incorporate an article that contradicted an element of the main legislation, however the Ministry of Health was examining the possibility of revising The Order.

3.85. With regards to the concerns over the Product Notifications, the Good Manufacturing Practice Certificate, Parallel Imports and Nano Notifications, Israel was currently re-examining the text of the Regulations and the need to revise them. During this process all the comments submitted would be examined, including those of the EU and Korea, and the remarks would be borne in mind as the

Regulations were processed by Israel's parliament (the Knesset). Regarding the Product Information File (PIF), the provisions of Article 23 in the Draft Regulations allowed for the digital storage of the Cosmetics File. The Draft Regulations did not require that the Cosmetics File be held physically in the company offices. Similarly, with respect to the EU's comments regarding the maintenance of documentation and its presentation for examination by the Ministry of Health, as part of the

development of the Regulations, Israel would examine the comments and take them into account.

23 For previous statements follow the thread under IMS ID 552 (under dates raised and references).

Page 16: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 16 -

Finally, with respect to the Implementation Period, Regulation 70 of the Draft Regulations determined an initial requirement which would become effective within a year of their publication.

3.4.8 Brazil — Draft Technical Resolution n° 51, 7 April 2017 on labelling of beverages, wine, and grape derivatives, G/TBT/N/BRA/719 and G/TBT/N/BRA/719/Add.1 (IMS ID 55724)

3.86. The representative of the European Union referred to the written comments of 16 August 2017 and the previous statements made at previous TBT Committee meetings. The EU stressed the

importance for producers of clear and proportional requirements on labelling and asked that Brazil clarify how this draft related to other regulations, including general rules on consumer protection and specific regulations on wine, as they appeared to overlap. The EU encouraged Brazil to apply to the greatest possible extend international standards adopted by the OIV. Given the time that had elapsed since the notification and submission of comments, the EU asked what was the state of play of the adoption procedure. She invited Brazil to take the EU concerns into account when preparing

the final resolution and to reply to the EU written comments.

3.87. The representative of Brazil informed the Committee that the process of draft TR No. 51 was still in progress and Brazil was therefore not in a position to provide replies to the comments submitted by the EU. The comments were still being analysed by the Ministry of Agriculture. He informed the Committee that new consultations and a public hearing were being organized in 2019, where interested parties would again be able to express their views on the draft regulation.

3.4.9 European Union — Regulation of the European Parliament and of the Council laying

down rules and procedures for compliance with and enforcement of Union harmonization legislation on products and amending relevant regulations G/TBT/N/EU/542 (IMS ID 56525)

3.88. The representative of China raised concerns about the EU's Regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement

of Union harmonization legislation on products and amending relevant regulations. The full statement is contained in G/TBT/W/617.

3.89. The representative of the United States noted that it also had concerns and had requested the EU to re-notify.

3.90. The representative of the European Union said that safety and compliance of products was an important matter for consumers. Public authorities in EU member States had to be able to check that products on their home market were safe for their citizens. The market surveillance authorities in the EU faced difficulties in checking compliance of goods originating outside the EU. Therefore,

the EU proposal for a Regulation contained a requirement that there should be a person in the EU responsible for compliance information on products. It was also recalled that this was not a new approach. A significant number of EU laws on products had similar provisions but they did not achieve the desired effect due to new types of e-commerce supply chains. Negotiations between the

European Parliament and the Council had resulted in a political agreement on the Regulation in February. This agreement still needed to be formalised, but the details were already available.

3.91. Regarding the provision for an interlocutor in the EU, the main change was with respect to

product scope. It would only apply to 18 EU laws on products, instead of 66 as foreseen in the initial proposal. It would apply to product categories such as electronic and electrical equipment, machinery and toys, but not to product categories which had been initially considered, such as batteries, paints, textiles and footwear. The interlocutor would have to provide information to the authorities on request and cooperate with them but would not be liable for non-compliance of the product. This liability for non-compliance would remain on the manufacturer in accordance with the current applicable regulatory framework in the EU.

3.92. The representative of the EU went on to note that exceptions based on the type or size of economic operators could not be justified because this would fail to address the problem and create unfair competition between economic operators. However, for offers for sales online, the EU's

24 For previous statements follow the thread under IMS ID 557 (under dates raised and references). 25 For previous statements follow the thread under IMS ID 565 (under dates raised and references).

Page 17: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 17 -

requirements would only apply if sales were targeted at EU end-users. The Regulation would also streamline the powers of market surveillance authorities that would be bound by the principle of proportionality in the exercise of their duties. It would, as of mid-2021, give sufficient time to implement the new requirement for products where there was not yet any such interlocutor in the EU. Once the legislative procedure was finalised, the European Union would keep Members duly informed about the adoption of the final measure.

3.4.10 Chile — Public Consultation for draft legislation setting out rules on the preparation, description and labelling of milk products deriving from milk, G/TBT/N/CHL/442 (IMS ID 56626)

3.93. The representative of the European Union reiterated previously raised concerns.27

3.94. The representative of New Zealand said that her delegation acknowledged and supported

Members' right to regulate to achieve legitimate health objectives, including Chile's efforts to protect

the health of consumers. However, New Zealand considered that Chile's specific proposed legislation was not consistent with CODEX Standards and, consequently, that it constituted an unnecessary barrier to trade. New Zealand urged Chile to correct such inconsistencies. In New Zealand's view, Chile's proposed measure was inconsistent with CODEX standards for the following reasons:

a. It did not allow cheeses made from milk powders, or from other products obtained from milk, to be labelled as "cheese" but only as "milk product similar to cheese". This would mean that cheese made from products other than milk, such as milk powders, would not

be allowed to be commercialised as "cheese", which was inconsistent with Codex General Standard for Cheese, CODEX STAN 283-1978. According to CODEX STAN 283-1978 raw materials for cheese manufacture should be "milk and/or products obtained from milk". This Codex Standard placed no restriction on the use of milk powders and/or other products obtained from milk as raw materials for cheese production.

b. It contained unclear definitions for "milk" and "reconstituted milk". It also included new terms that were not, however, defined, such as "liquid milk" or "milk enhanced with

reconstituted powdered milk". Furthermore, the proposed definitions did not align with CODEX STAN 206-1999 (Codex General Standard for the Use of Dairy Terms).

3.95. The representative of Chile stated that this draft was currently still being considered by the legislative congress. Chile would keep Members informed on the progress of this piece of legislation currently under discussion in its congress.

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

United Arab Emirates, Yemen — GCC Technical Regulations for the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (IMS ID 57228)

3.96. The representative of the United States thanked GCC members for acknowledging receipt of

US industry comments submitted on 25 May 2018 and for confirming that they were being taken into account. The US was still awaiting acknowledgement that the appropriate authorities had received the US Government comments of October 2018 and asked for confirmation that the regulation was still undergoing review and revision. She reiterated the concerns raised in the

previous meeting.29

3.97. The representative of the European Union supported the comments made by the United States. In March 2018, the GSO had notified the draft of GCC Technical Regulations for the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment. The EU had commented on the draft text, to which the GSO had responded in July 2018. However, there remained uncertainties in terms of requirements as well as timing of adoption and entry into force. Firstly, there was uncertainty about the process and timelines to transpose requirements into

national legislation. The EU sought clarification on when the measure would be transposed in each individual country and whether it would replace existing regulation. Second, a longer transition

26 For previous statements follow the thread under IMS ID 566 (under dates raised and references). 27 G/TBT/M/76, paras. 3.9-3.10. 28 For previous statements follow the thread under IMS ID 572 (under dates raised and references). 29 G/TBT/M/76, paras. 3.28-3.29.

Page 18: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 18 -

period to adapt would ensure a smoother implementation for economic operators. Third, there remained uncertainty regarding the requirements for declaration of conformity. The proposal appeared to include a mandatory third-party conformity assessment, which would deviate from common international practice. The EU therefore urged GCC members to accept conformity assessments already done in the EU for these products, in order to avoid the administrative burden and costs of approval by third party assessments. Fourth, the EU sought clarification on whether

conformity assessments approved for one GCC member state would be recognized in others. If this was not already the case, the EU urged the GCC to ensure that this would be possible. Finally, the EU was concerned by the lack of clarity regarding the scope. Annex 1 seemed to provide an exhaustive list, but this had not been confirmed. The EU asked that GCC members clarify these uncertainties as soon as possible.

3.98. The representative of Oman, speaking on behalf of GCC member states, said that the measure

was intended to regulate electrical and electronic equipment with a view to contributing to the

protection of human health and the environment, including the environmentally sound recovery and disposal of waste. It was also intended to harmonize the GCC approach to hazardous substances in electrical and electronic equipment. Since the notification of the draft regulation in March 2018, the GCC had been receiving a series of questions, most recent of which was from the US in October 2018. He acknowledged that more time would be required to review the responses that they had just submitted that day. Regarding the questions and comments posed by the EU, he asked that

they be provided in written form so that they could be transmitted to the GSO for their consideration. He reiterated their readiness to discuss any further questions bilaterally.

3.4.12 China - Insurance Regulatory Commission (CIRC) Information and Communication Technology Regulation (IMS ID 48930)

3.99. The representative of the European Union referred to the comments made in previous TBT Committee meetings and reiterated the concerns raised in the November 2018 meeting.31

3.100. The representative of the United States said her delegation remained very concerned with

China's suite of measures that appeared to discriminate against foreign technologies and companies in the name of information security. These included the Cybersecurity Law and the draft Insurance Sector Informatization Rules, amongst others. The US shared the concerns of the EU and looked forward to continued discussion on this important issue with China.

3.101. The representative of China informed the Committee that following the merger of the former CBRC and CIRC, it was necessary to draft the Information and Communication Technology

Regulation. China always abided by its WTO commitment and was open and transparent when drafting information technology measures in the banking and insurance sectors, where domestic and foreign companies were treated equally.

3.4.13 Indonesia — Halal Product Assurance Law No. 33 of 2014 (IMS ID 50232)

3.102. The representative of the United States reiterated concerns raised in the previous TBT Committee meeting.33

3.103. The representative of the European Union raised concerns regarding the Indonesian Halal

Product Guarantee Law No 33 of September 2014. The full statement is contained in G/TBT/W/630.

3.104. The representative of Brazil reiterated concerns raised in the previous TBT Committee meeting.34 He expressed his delegation's interest in participating in any future public consultations regarding this issue.

3.105. The representative of New Zealand requested that Indonesia update the Committee on the implementation of the Mandatory Halal Law. Regarding the implementation timeframes, New Zealand request further information on the phased implementation across different products for

30 For previous statements follow the thread under IMS ID 489 (under dates raised and references). 31 G/TBT/M/76, para. 3.41 and G/TBT/W/567. 32 For previous statements follow the thread under IMS ID 502 (under dates raised and references). 33 G/TBT/M/76, paras. 3.108-3.110. 34 G/TBT/M/76, para. 3.11.

Page 19: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 19 -

when certification would become mandatory. Further information on the timeframe for the transition of responsibilities to Indonesia's Halal Product Assurance Agency (BPJPH) and the steps taken to ensure continued recognition of foreign halal certification was also requested. New Zealand would welcome any updates on the discussions that were ongoing amongst government institutions regarding the inclusion of information on non-halal products.

3.106. The representative of Australia said it was understood that Indonesia's Halal Product

Assurance Law No.33 of 2014 would take effect from 17 October 2019, with a likely phased implementation period of between five to seven years. Australia recognized the importance of halal product assurance to many Indonesian consumers and requested the most recent version of the Halal Law be provided in advance of its implementation to ensure all trading partners had time to prepare and adjust to the changes. Australia encouraged Indonesia to establish an open dialogue with trading partners to ensure foreign businesses and their valued Indonesian importers remained

adequately informed of new requirements under the Halal Law. Australia looked forward to joint

cooperation to ensure a smooth implementation of the Halal Law and minimise any disruptions to existing trade. Australia welcomed Indonesia's statement at the previous TBT Committee meeting that the proposed regulation would be in line with the TBT Agreement and would take into account trading partners' concerns to ensure the requirements were not more trade restrictive than necessary.

3.107. The representative of Canada said that Canada was also following developments regarding

the implementation of the Halal product assurance law and thanked Indonesia for the bilateral meetings. He reiterated, like other Members, Canada's interest in a clear operating environment for exporters and asked what the timeline for implementation of the law and for the phase-in was.

3.108. The representative of Indonesia emphasized that this law was to provide certainty to Indonesian society about halal products, rather than prohibiting the sale and circulation of non-halal products. As the country with the largest Muslim population in the world, it was necessary for product information to be sufficient to ensure halal integrity. As the implementation provision of Law No

33/2014, implementing and technical regulations under that Law were currently under discussion and/or finalisation. The technical regulation would include the scope of halal-mandatory products, the transition process, labelling of halal products and Mutual Recognition Arrangements (MRAs) for halal certification scheme. Indonesia believed that in fulfilling halal certification, mutual recognition and acceptance were necessary between interested parties so as to reduce any unnecessary technical barrier. Thus, Indonesia was fully committed to applying the principles of mutual

recognition and acceptance of the certification process carried out by certification bodies outside Indonesia with the proviso that the certification bodies outside Indonesia were either accredited by accreditation bodies with an MRA with KAN (Indonesia Accreditation Body) or had signed a mutual acceptance cooperation with the Indonesian Government based on mutual reciprocity principles.

3.109. To provide enough information for the consumer, Indonesia needed to ensure that all halal-mandatory products complied with the required halal labelling. Nonetheless, to reduce any unnecessary cost and barrier for imported products, Indonesia would allow the use of halal-labels

from certification bodies that were mutually recognized and accepted by Indonesia as long as a

registration number from BPJPH was included in the products. Products containing non-halal ingredients could still circulate, enter, and trade in Indonesia by including non-halal information complying with the regulation of The Head of National Agency for Drug and Food Control Republic of Indonesia No. HK.03.1.23.06.10.5166 Year 2010 concerning inclusion of the Information on Particular Substances, Alcohol Content and Expired Date on The Label of Drug/Medicine, Traditional Medicines, Complementary Medicines, and Food. Indonesia assured the Committee that the

implementation of the Law would not limit people's freedom to choose their desired products.

3.4.14 Russian Federation – Rules of cement certification, G/TBT/N/RUS/48, G/TBT/N/RUS/49 (IMS ID 49735)

3.110. The representative of the European Union continued to raise concerns with the Russian Federation's measures on rules of cement certification. The full statement is contained in G/TBT/W/631.

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

Page 20: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 20 -

3.111. The representative of Ukraine shared the EU's concerns and repeated its statement made in previous Committee meetings with regard to the clearly overly restrictive certification requirements for cement. Her delegation asked the Russian Federation to take the concerns expressed into consideration to ensure that the requirements and rules were in line with Russia's obligations under the TBT Agreement and did not cause unnecessary obstacles to trade.

3.112. The representative of Mexico recalled her delegation's systemic interest in the issue.

3.113. The representative of the Russian Federation stated that amendments to GOST-R "Rules of cement certification" abolishing additional border inspection were currently being discussed internally between different Russian authorities but that precise timeline for the outcome of the discussions could yet be provided. He indicated that a notification would be made to the WTO and that his delegation was ready to discuss the issue bilaterally.

3.4.15 China — Cyberspace Administration of China – Draft implementing measures for

the Cybersecurity Review of Network Products and Services (IMS ID 53336)

3.114. The representatives of Japan and the United States reiterated previously raised concerns.37

3.115. The representative of the European Union reiterated previously raised concerns.38

3.116. The representative of China informed the Committee that the measure which established the review mechanism of cyber security had been released in May 2017 to improve the secure and controllable level of network products and services, prevent the security risk of the supply chain, safeguard national cyber security and protect the interest of the people. China clarified that the

system was also conducive to increasing the confidence of the market and the consumers on products and services of the information technology. Moreover, not all products and services required review, the focus was on those that would affect national security applied in critical information infrastructures and important information systems. As such, he stated that the security

review would not violate the intellectual property right of enterprises as the Chinese government attached great importance to IPR protection and protected IPR in accordance with the law. He remarked that great efforts had been made to ensure that there were no violations of enterprise IPR

in any form and as such the review would not damage commercial secrets of enterprises as well as the IPR. China concluded by stating that there were no national differences in the review and it could help increase the confidence of consumers in the products and expand the market space of the enterprises.

3.4.16 China — Draft revised Encryption Law of the People's Republic of China by the Office of State Commercial Cryptography Administration (OSCCA) (IMS ID 53439)

3.117. The representative of the United States reiterated previously raised concerns.40

3.118. The representative of the European Union reiterated previously raised concerns with China's

draft revised Encryption Law.41 The full statement is contained in G/TBT/W/632.

3.119. The representative of Japan requested China to update Members on the status of revision to the draft Encryption Law, and in addition, to clarify whether the following four points pointed out by her delegation in previous meetings were reflected in the revised draft.42 First, to clarify the definitions of terms, the concrete requirement for review and the scope of regulation. Second, to

clarify the relevance of this Encryption Law to existing security regulations such as the "the Cybersecurity Law". Third, to ensure that foreign company market access in China dealing in cryptography-utilizing products would not be hampered and that confidential technology would not

36 For previous statements follow the thread under IMS ID 533 (under dates raised and references). 37 G/TBT/M/76, para. 3.161. 38 G/TBT/M/76, para. 3.162 and G/TBT/W/593. 39 For previous statements follow the thread under IMS ID 534 (under dates raised and references). 40 G/TBT/M/76, paras. 3.166–3.167. 41 G/TBT/M/76, para. 3.165 and G/TBT/W/593. 42 G/TBT/M/76, para. 3.165; G/TBT/M/75, para. 4.183; G/TBT/M/74, para. 2.218 and G/TBT/M/73,

paras. 2.19–2.21.

Page 21: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 21 -

be leaked. Fourth, to ensure that the development of relevant regulations and procedures were consistent with international standards and practices.

3.120. The representative of China said that China would press forward with the legislation of the Law on Cryptography in accordance with the Legislative Law and adhere to the principles of law-making in a well-conceived and democratic way and in accordance with law. China would carry out scientific verification and public consultation to ensure stakeholders participate in the legislative

activity through legal channels. The Law on Cryptography (Draft for consultation) had been released in April 2017 for public consultation. Domestic and foreign parties had provided many constructive suggestions. China was actively researching and adopting the relevant suggestions from all parties and pressing ahead with further revision of the Draft, which would further reduce the number of administrative licenses and regularize market access.

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

Directive (IMS ID 55343)

3.121. The representatives of Indonesia, Colombia and Malaysia raised concerns with the European Union's Renewable Energy Directive. The full statements are contained in G/TBT/W/615, G/TBT/W/602 and G/TBT/W/598, respectively.

3.122. The representative of Ecuador supported the position of Indonesia, Colombia and Malaysia, and welcomed the analysis conducted. Ecuador acknowledged that the EU was seeking to meet its climate-related goals, along with all signatories of the Paris Agreement, working as they were in

accordance with their own national agendas to eliminate deforestation from supply chains, as part of their commitment to, and support for, mitigating the effects of climate change. However, the rural development capacities of a predominantly agricultural country should not be limited, and the restriction of trade through the extrajudicial application of national agendas based on non-consensual measures was not justified by a legitimate environmental objective.

3.123. Like Colombia, Ecuador considered that the criteria established would directly affect palm oil but not fuels produced from other types of vegetable oil. This was inconsistent with the obligation

contained in Article 2.1 of the TBT Agreement and Article I:1 of GATT 1994. Furthermore, since the proposal favoured vegetable oils produced in the EU, it also violated the principle of national treatment contained in Article 2.1 of the TBT Agreement and Article III:4 of the GATT 1994.

3.124. The act, established pursuant to Article 26 of the Directive, provided for specific standards on biofuels, bioliquids and biomass fuels produced from food or feed crops, to address emissions produced by indirect land-use change (ILUC). This methodology and the characterizations applied

through the establishment of general, specific and additionality criteria for the certification of biofuels, bioliquids and biomass fuels were not subject to multilateral negotiations within the framework of the Paris Agreement, which was the source of the main commitments of the European Directive.

3.125. The ILUC methodology was not extensively discussed at the international level. The methodology was unclear and had not been endorsed by international experts or sufficiently disseminated, and therefore was considered as a new technical requirement that would covertly

affect palm oil production and marketing processes. Ecuador requested that the EU comply with the WTO principles of transparency and harmonization.

3.126. To date, the European Commission had not included the ILUC methodology in its calculations of greenhouse gas emissions, and therefore failed to comply with the principle of national treatment. She said third countries should not be expected to apply a methodology that provided no certainty regarding the hypotheses used, benchmarks for palm oil plantations, estimates of greenhouse gas emissions in the production of palm oil, or projections concerning the types of land to be used for

the expansion of palm oil crops.

3.127. Lastly, it was important to underscore the significant progress Ecuador had made in reducing emissions and was currently a leader in the implementation of actions and measures for reducing

emissions from deforestation and forest degradation (REDD+). This commitment had already been

43 For previous statements follow the thread under IMS ID 553 (under dates raised and references).

Page 22: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 22 -

made by the Ecuadorian palm-growing sector, which signed an agreement to move towards deforestation-free production, with clear zero-deforestation goals and commitments.

3.128. Ecuador was second globally in meeting the requirements established by the UN Framework Convention on Climate Change to gain access to performance-based payments. It was therefore fundamental that such achievements made in the context of international agreements be taken into consideration when establishing this type of restriction.

3.129. Ecuador had set itself the goal of reducing emissions from deforestation and had achieved it. Its average gross annual rate of deforestation was 94,353 hectares in the period 2015-2016, compared with 129,943 hectares in the period 1990-2000, representing a decrease of 27%, and a reduction of over 29 million tonnes of CO² equivalent between 2009 and 2014. She requested that the EU pursue dialogue with palm-oil producing countries, so as to take into account the efforts that had been made and ensure these efforts were reflected in legislation.

3.130. The representative of Costa Rica supported the concerns raised by Colombia, Indonesia and Malaysia regarding the amendments to Directive 2009/28/EC on renewable energy. He expressed concern regarding the proposed criteria for determining indirect land use change and identifying a low risk of indirect land use change with regard to biofuels. He underscored that Costa Rica was a pioneering and committed country in the field of environmental protection. It was one of the few countries that had been able not only to carry out reforestation, but also to reverse the trend of deforestation. Costa Rica had one of the few coal-free electrical systems in the world. In 2017,

99.5% of electricity in Costa Rica was generated without using fossil fuels, which was the highest percentage in 30 years. While Costa Rica clearly welcomed the efforts of the European Union to establish an appropriate policy on the use of renewable energy, such efforts should not be allowed to damage the marketing conditions for products based on criteria that lacked scientific substantiation. Based on the introduction of the concept of biofuels with a low risk of causing indirect land use change, the EU would be able to recognize the singularity of palm oil cultivation in Costa Rica and other areas in Latin America.

3.131. The representative of Guatemala, as a palm oil-producing country supported the concerns raised by other delegations. While this measure did not limit the use of palm oil, it did discourage its use, thereby discriminating against palm oil as opposed to other vegetable oils and in particular oils produced by the European Union, putting palm oil at a disadvantage. In 2017, palm oil was Guatemala's sixth main export. The EU was one of its main markets for palm oil and these new measures would have a major impact on bilateral trade. The palm oil agro-industry in Guatemala

accounted for some 28,000 direct jobs, particularly in rural areas, and 85,000 families within the country benefitted from its production.

3.132. The production sector was making the necessary efforts to generate sustainable production, implementing policies at the private sector level and estimating greenhouse gas (GHGs) emissions in palm oil production, thus demonstrating the priority given and its commitment to these issues. Furthermore, Guatemala thought it necessary to differentiate between palm oil production and production conditions. The global production of palm oil could not be condemned and along with it

the many families whose daily livelihood depended on this crop. Guatemala reiterated its commitment to meeting the UN SDGs, and its support for sustainable palm oil certification with a view to meeting the Millennium Goals.

3.133. The decision made by the Trilogue (European Commission, European Parliament and Council of Europe) and its final approval in 2019 was worrying, especially as some palm oil-producing countries had requested a hearing with the Presidents of the Trilogue but had not received a positive reply in writing to enter into dialogue. Guatemala was concerned about the negative impact of these

measures and the lack of transparency in the process. Guatemala would continue to participate actively in the TBT Committee and in Brussels on this measure so as to prevent the establishment of discriminatory measures, in accordance with WTO principles.

3.134. The representative of Thailand once again registered interest in this matter and called for equitable treatment of palm oil to other oil crops. Thailand appreciated receiving the EU's updated

information and looked forward to further clarification on the questions raised by Members.

Page 23: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 23 -

3.135. The representative of the European Union noted that the revision of the Renewable Energy Directive had also been discussed in several bilateral meetings among experts. The official text of the revised RED had been published on 21 December 2018, providing further clarity on concerns raised, notably on the fact that the Directive did not impose a ban on, or otherwise single out, any specific biofuel. In this regard, and as stated on many occasions, the RED as such did not appear to fall within the scope of the TBT Agreement. In line with the RED, the Commission had prepared a

draft Delegated act to supplement the Directive as regards the determination of high indirect land-use change-risk feedstock for which a significant expansion of the production area into land with high carbon stock was observed and the certification of low indirect land use change-risk biofuels, bioliquids and biomass fuels. The draft Delegated Act contained further details regarding the determination of ILUC. A public consultation was currently ongoing on the draft Delegated Act and was open for feedback until 8 March 2019.The EU remained available for discussions through the

appropriate bilateral channels.

3.4.18 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 27444)

3.136. The representative of the European Union expressed her appreciation for the clarifications and explanations provided by India at previous meetings. She asked for clarification on the effective date of entry into force of the testing requirements. India had published several notifications that specified products for which in-country testing and certification would be made mandatory. The EU stressed the need to allow adequate time before the entry into force of these requirements in order for affected stakeholders to have an opportunity to review the final requirements, including any applicable standards and procedures. The EU was concerned about an announcement regarding the

extension of the requirement of in-country testing/certification to all equipment to be connected to

Indian networks, beyond the telecom network elements. She asked whether India could confirm this information and if so, indicate the relevant international standards and how legal predictability would be ensured in the meantime. On the recognition of test results carried out outside India, the EU reiterated its concerns that mandatory in-country testing did not appear to add any value in terms of safety of the covered equipment. A delegation from the Indian Department of Telecommunications

was expected to visit the EU during the last week of March to see the operation of the EU system and discuss possible recognition instead of in-country testing.

3.137. The representative of the United States referred the Committee to the statement made at the November 2018 meeting.45

3.138. The representative of Canada indicated that his delegation continued to have concerns about India's in-country security testing requirements. The ongoing delays in implementing the measure demonstrated that the Indian government was aware of the supply chain problem this requirement

could create. He asked whether India would reconsider its approach and adopt the international best

practice of using international common criteria and accepting products tested in any accredited lab, whether located in India or elsewhere.

3.139. The representative of Japan reiterated concerns raised in previous TBT Committee meetings.46

3.140. The representative of India responded to the concerns raised. The full statement is contained in G/TBT/W/621.

44 For previous statements follow the thread under IMS ID 274 (under dates raised and references). 45 G/TBT/M/76, para. 3.36. 46 G/TBT/M/76, para. 3.37.

Page 24: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 24 -

3.4.19 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) (IMS ID 29447)

3.141. The representative of Japan reiterated concerns raised at the previous TBT Committee meeting.48 In addition, Japan requested that China notify the draft to the WTO in order to allow

Members the opportunity to comment.

3.142. The representative of the European Union reiterated concerns on China's new Cybersecurity Law for the existing rules, notably the Multi-Level Protection Scheme ('MLPS'). The full statement is contained in G/TBT/W/633.

3.143. The representative of Australia reiterated concerns raised in previous TBT Committee

meetings.49 Australia understood China's desire to protect ICT infrastructure but continued to

question whether the proposed measures were not more trade restrictive than necessary.

3.144. The representative of China informed the Committee that China was organizing the revision of the Regulations on Commercial Cryptography to further reduce the administrative licenses and strengthen supervision in the whole process so as to implement the requirements of promoting administration according to law, deepen the administrative reform and transform government functions in the domain of commercial cryptography. The revision of the Regulations on Commercial Cryptography had not yet been finalized. After the promulgation of the Law on Cryptography, China

would continue to revise the Regulations on Commercial Cryptography according to the Law on Cryptography and release the regulations for public consultation at an appropriate time. As IT developed, information security multi-level protection schemes needed to be improved to meet the increasingly complicated cyber security circumstances. Based on experiences over the previous years and responding to new development, the Cybersecurity Law stipulated that China would carry out the cybersecurity MLPS, which was based on the information security MLPS. To fulfil the

requirements in the Cybersecurity Law, regulations on the cybersecurity MLPS were being drafted,

which would replace the former administrative measures on the information security MLPS. When completed, the regulation would be open for comments.

3.4.20 Russian Federation — Draft Technical Regulation on Alcohol Drinks Safety (published on 24 October 2011), G/TBT/N/RUS/2 (IMS ID 33250)

3.145. The representative of the European Union reiterated concerns on the Russian Federation's technical regulations on alcohol products safety. The full statement is contained in G/TBT/W/634.

3.146. The representative of Ukraine reiterated its request that this measure be adjusted so that it complies with the TBT Agreement transparency requirements and in in line with international practices.

3.147. The representative of the Russian Federation informed the Committee that the Technical Regulation had been adopted on 5 December 2018 and would enter into force on 5 January 2021. Alcohol Drinks Safety Technical Regulations were not uniform across the alcohol sector. Some international companies including those based in Europe, specifically in the beer sector, publicly

supported the new regulation as it would make alcohol companies in Russia more flexible. Companies would be able to offer more types of products and better satisfy consumer needs. With regards to concerns raised about inappropriate use of EU Geographical indications, he stressed that this technical Regulation did not confine the rights to register geographical indicators in the Russian Agency of Intellectual Property and their consequential use. He questioned the relevance to the TBT Agreement of the EU concern on the non-recognition of EU production practices. Russia looked forward to continued constructive engagement with interested Members and the comments and

concerns raised would be conveyed to the regulatory authorities in Moscow.

47 For previous statements follow the thread under IMS ID 294 (under dates raised and references). 48 G/TBT/M/76, para. 3.40. 49 G/TBT/M/76, para. 3.43; G/TBT/M/75, para. 4.47; 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. 50 For previous statements follow the thread under IMS ID 332 (under dates raised and references).

Page 25: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 25 -

3.4.21 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 36751)

3.148. The representative of the United States referred the Committee to statements delivered in previous TBT Committee meetings.52

3.149. The representative of Canada supported the concerns raised by others and sought

clarification as to whether it was now the case that only the Indian company importing the good, not any Indian company, could apply for registration. Given that India had indicated that it was open to MRAs with foreign labs, he asked how many MRAs had been signed by the BIS.

3.150. The representative of India responded to the comments made. The full statement is contained in G/TBT/W/622.

3.4.22 European Union — Hazard-based approach to plant protection products and setting

of import tolerances 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 39353)

3.151. The representative from Canada reiterated previously raised concerns54 and stated that her delegation remained concerned with the trade implications of the hazard-based approach taken by the EU on the regulation of active substances in plant protection products. Canada recognized Members' right to implement measures to achieve legitimate policy objectives, such as the protection of human health and safety, or protection of the environment, provided such measures are no more

trade restrictive than necessary. Finally, Canada requested the EU to provide any available information indicating how the EU planned to work with trading partners to avoid unnecessary disruptions to trade.

3.152. The representative of Argentina referred the Committee to concerns raised at previous

sessions regarding Commission Regulation (EU) 2018/605 (criteria for the determination of endocrine disrupting properties).55 The representative of Argentina requested the Commission, in regard both to substances with endocrine disrupting properties and to any other substance coming

under the cut-off criteria, to maintain MRLs and the application of import tolerances on the basis of risk assessments, having regard to the provisions of Regulation No. 396/2005 because otherwise, this measure would lead to the creation of more significant, unnecessary and disproportionate barriers to international trade in agricultural products, without any scientific justification.

3.153. The representative of the United States reiterated concerns raised in previous meetings56 and noted that the EU had proceeded with implementing the regulations despite 15 interventions by

WTO Members at previous Committee meetings. The US remained concerned with the EU's hazard-based approach to pesticide regulation, its implementation of criteria for identifying and subsequently banning endocrine-active substances and with the EU's opaque process for managing import tolerances for substances that triggered the hazard-based cut-off criteria. In light of the

concerns raised, the representative of the US requested the EU to explain its objectives as identifying hazards without identifying ascertainable risks or considering reasonable methods for managing risk raised concerns that could be more trade-restrictive than necessary.

3.154. The representative of Paraguay raised previously raised concerns and stated that her delegation remained concerned with the series of decisions taken by the EU not to renew the approval of substances and to amend the MRLs of these substances, without considering risk assessments or ensuring compliance with the Codex Alimentarius standards. Moreover, Paraguay was further concerned by the fact that the European Food Safety Authority (EFSA) did not obtain conclusive results regarding the risk assessment of certain substances because the data in the dossier was insufficient, which implied that the result was not decisive. The representative of

Paraguay reiterated concerns raised in the last session of the Committee, and in the SPS Committee,

51 For previous statements follow the thread under IMS ID 367 (under dates raised and references). 52 G/TBT/M/76, para. 3.59; G/TBT/M/75, para. 4.67; and G/TBT/M/74, para. 2.89. 53 For previous statements follow the thread under IMS ID 393 (under dates raised and references). 54 G/TBT/M/76, para. 3.62 and the full statement contained in G/TBT/W/588. 55 G/TBT/M/76, para. 3.62 and the full statement contained in G/TBT/W/563. 56 G/TBT/M/76, para. 3.63; and G/TBT/M/75, para. 4.71 and full statement contained in G/TBT/W/541.

Page 26: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 26 -

regarding the use of a hazard-based approach to regulate these substances because it would result in unnecessary barriers to trade and would adversely affect producers. Her delegation noted that at the last meeting of the Committee, this STC had been raised by 15 delegations, and in the Committee on SPS Measures held in November 2018, 21 delegations had expressed concern about the matter, however, the EU was yet to provide a response. Paraguay requested the EU to perform full risk assessments, avoid unnecessary trade restrictions, and provide reassurance to Members regarding

the policy on import tolerances.

3.155. The representative of Costa Rica supported the concerns raised by other Members and reiterated his continuing concern with the approach taken by the EU to implement Regulation (EC) No. 1107/2009, which led to the adoption of a hazard-based decision criterion. Costa Rica requested the EU to ensure that the implementation of this Regulation was based on the use of risk assessments for the identification and regulation of endocrine disruptors, through the application of

criteria supported by sufficient scientific evidence, in line with the commitments established in the

TBT Agreement.

3.156. The representative of Brazil reiterated previously raised concerns.57

3.157. The representative of India reiterated previously raised concerns.58 In addition, India requested the EU to withdraw the hazard-based measure or consider other options available within the WTO SPS framework.

3.158. The representative of Thailand reiterated previously raised concerns and stated that

although her delegation supported the EU's right to take necessary measures to protect human health and the environment, such measures should be based on risk assessment and harmonized with relevant international standards. Thailand remained concerned with the implementation of the hazard cut-off criteria for identifying substances having endocrine disrupting properties might affect the MRLs of previously authorized substances, which would constitute a disguised restriction on the international trade. The representative of Thailand therefore requested the EU to establish the MRLs

and import tolerance of endocrine disrupting substances according to the principle of risk assessment

to adopt the existing international standard MRLs to minimize the adverse impact on trade. Furthermore, Thailand requested the EU to expedite the drafting process of the criteria for derogation by determining the meaning and criteria for negligible risk and notify it to WTO for comments.

3.159. The representative of Uruguay supported the concerns raised by other Members and stated that his delegation remained concerned with the use of a hazard-based approach by the EU which did not respond to scientific evaluation of the risk-based methodology.

3.160. The representative of Colombia supported the concerns raised by other Members and reiterated previously raised concerns.59 Colombia also highlighted the importance of performing a risk analysis, a methodological tool for decision making with three main components: assessment, management and communication, with regard to pesticide use, in order to protect public health and the environment, and as a means of facilitating international trade in agricultural products. Her delegation argued that upon examination of the proposal by the EU, it appeared that a risk

assessment was deemed irrelevant, and instead a hazard-based approach had been adopted with

regard to the decision to accept or allow the use of substances, which meant that the conditions of use that may identify risk scenarios and allowed for science-based decisions to be made had been overlooked. The representative of Colombia requested the EU proposal to take into account scientific evidence, production processes and methods, the international recommendations of the Codex Alimentarius on MRLs, and the relevant ecological and environmental conditions in countries that may be affected by the implementation of the measure, in order to avoid creating unnecessary technical barriers to trade. The representative of Colombia also stated that her delegation remained

concerned that these measures encouraged the gradual extension of the approach to other areas of sanitary regulation, which would have a significant and widescale impact on international trade in agricultural products and would entail a greater degree of restriction on trade than necessary to achieve the appropriate level of sanitary protection sought by the EU.

57 G/TBT/M/76, para. 3.67. 58 G/TBT/M/76, para. 3.75. 59 G/TBT/M/76, para. 3.66.

Page 27: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 27 -

3.161. The representative of Guatemala reiterated previously raised concerns60 about the EU's policy for identifying endocrine disruptor criteria, particularly because it lacked any scientific basis, and requested the EU to clarify the options under consideration to avoid blocking trade and agricultural exports.

3.162. The representative of Australia reiterated previously raised concerns61 regarding the importance of adopting a risk-based approach for regulating endocrine disrupting chemicals (EDCs)

rather than considering only the potential for harm due to the intrinsic properties of a chemical.

3.163. The representative of Panama recalled previously raised concerns62 regarding the unnecessarily trade restrictive measures that were hazard based and not risk assessed. His delegation requested the EU to align the measures with the Codex so that it would not unnecessarily obstruct trade.

3.164. The representative of the European Union repeated responses provided in the previous

Committee meeting63 and stated that his delegation was aware of concerns regarding the EU policy on plant protection products for the definition of scientific criteria to identify endocrine disruptors and other, more specific concerns, on whether import tolerances could be established for substances not authorized in the EU, due to the so-called "cut-off" criteria in Regulation (EC) No 1107/2009. After examining the different policy options and taking into account the concerns raised by stakeholders, member States and third countries, the EU informed Members that it had decided to follow the procedures laid down in Regulation (EC) No 396/2005 for the management of import

tolerance requests concerning active substances falling under these cut-off criteria. According to his delegation, these procedures included a risk assessment by an Evaluating EU member State and a scientific opinion by the European Food Safety Authority (EFSA). The granting of the import tolerance would then be considered in line with risk analysis principles on a case-by-case basis and taking into account all relevant factors. The EU reiterated its commitment to act in full transparency and would keep Members duly informed about further developments.

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

G/TBT/N/RUS/29 (IMS ID 41864)

3.165. The representative of the European Union reiterated concerns raised in the previous TBT Committee meeting.65 The EU pointed out that Amendment 2 of the measure prohibited the use of "artificial leather" in insoles for children's shoes and related to the EAEU standard that provided definitions of "artificial leather", "synthetic leather" and "composition leather". In this respect, the EU wanted to know whether Amendment 2 prohibited all three notions listed in the EAEU standard:

"artificial leather", "synthetic leather" and "composition leather". The EU was concerned about these definitions as they deviated from international standards and practices (ICT, ISO and CEN) and were likely to create confusion between genuine leather and textile products, notably considering that the definition of "artificial leather" in the EAEU standard seemed to correspond to synthetic textiles. The prohibition of the use of such materials in insoles for children's shoes would mean a ban on the use of synthetic or artificial materials, regardless of their chemical content and without any justified pursued health or safety objectives.

3.166. The representative of the Russian Federation recalled its statement made in the previous TBT Committee.66 For public health reasons, the September 2018 amendments to the Technical Regulation prohibited the use of artificial leather in lining and insoles of children's shoes. Artificial leather was defined by EAEU legislation as fabric coated or impregnated with polymer or composition of polymers. Use of artificial materials including textile materials except for artificial leather was allowed. Statistics showed that the measure had not negatively impacted on Russia's shoe imports.

60 G/TBT/M/76, para. 3.69. 61 G/TBT/M/76, para. 3.64. 62 G/TBT/M/76, para. 3.70 63 G/TBT/M/76, para. 3.76. 64 For previous statements follow the thread under IMS ID 418 (under dates raised and references). 65 G/TBT/M/76, para. 3.77. 66 G/TBT/M/76, para. 3.78.

Page 28: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 28 -

In fact, Russia's shoe imports had increased both from the EU and internationally in the fourth quarter of 2018 as compared with the previous two quarters.

3.4.24 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 42867)

3.167. The representative of the Republic of Korea reiterated concerns raised in the previous TBT Committee meeting.68

3.168. The representative of China said that in January of 2018, China's Food and Drug Administration (CFDA) released guidelines on instructions for the work on the acceptance of overseas clinical trials results as clinical evaluation materials for medical devices. These guidelines would

reduce the duplication and speed up the marketing process. The Regulation for the Supervision and

Administration of Medical Devices adopted in 2014, had further simplified the requirements for registration. Firstly, they were set up to improve the classification management system. Based on level of their risks, the medical devices fall into 3 categories as class 1, class 2 and class 3. The requirements for low risk products were further streamlined. Secondly, to reduce the requirements on clinical trials, certain products were exempted from clinical trials. Thirdly, to simplify the re-registration’s requirements, following this regulation, former CFDA published an implementation notice, providing one-year transition period, and offering some transitional measure for registration.

In September of 2018, the National Medical Products Administration had published the new revised list for medical devices exempted from clinical trials, and 1248 medical devices are exempted from clinical trials, including 855 medical devices products and 393 in vitro diagnostic reagents (IVD reagents). 84 medical devices products were added while 277 IVD reagents were added.

3.4.25 China – Registration Fees for Drugs and Medical Device Products (IMS ID 46669)

3.169. The representative of the Republic of Korea continued to have concerns with the higher registration fees imposed on imported medical devices compared to domestically manufactured

ones. Such a measure was discriminatory and lacked clarity and transparency. China had responded that that higher registration fees for imported medical devices were due to the on-site inspection of facilities overseas. However as on-site inspection of manufacturing facilities for imported medical devices was not mandatory, it was unreasonable to include on-site inspection costs in the registration fees for all imported medical devices. Korea requested that China provide justification for its registration fee structure for imported medical devices, or, that China establish a fair and non-

discriminatory registration fee framework for both domestic and imported medical devices.

3.170. The representative of China informed the Committee that following the merger of the former CBRC and CIRC, the former CIRC’s Information and Communication Technology Regulation was drafted in response to the new circumstances. China always abided by its WTO commitment and was open and transparent when drafting information technology measures in the banking and insurance sectors, where domestic and foreign companies were treated equally.

3.171. The representative of China said that collecting registration fees for drugs and medical

devices was common practice internationally and the 624,000 RMB Yuan registration fee was much lower than other Members. The registration fees in China were calculated on the basis of costs of conformity assessment works, which reflected the different workloads and pricing levels.

3.4.26 China — Interim Measures for Quality Management of Commercial Coal (IMS ID 47770)

3.172. The representative of Australia said that Australia was a reliable, long-term supplier of high-quality coal to China and that China was Australia's second largest coal export market. Australia had

played an enduring role in contributing to energy security and industrialisation in China and respected China's right to ensure the use of coal within China met environmental standards. The

67 For previous statements follow the thread under IMS ID 428 (under dates raised and references). 68 G/TBT/M/76, para. 3.85; and G/TBT/M/75, para. 4.94. 69 For previous statements follow the thread under IMS ID 466 (under dates raised and references). 70 For previous statements follow the thread under IMS ID 477 (under dates raised and references).

Page 29: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 29 -

quality of Australian coal was amongst the highest in the world. Australia had noted reports of increased disruptions to imports of Australian coal at Chinese ports since November 2018, including delays of up to 40 days for Australian coal to be unloaded, compared to 20 days prior to November 2018. He asked China to confirm in writing whether recent disruptions to coal imports were related to the Interim Measures for Quality Management of Commercial Coal, notified on 18 September 2014. If the reported disruptions were a result of new measures, he asked China to provide written

copies of the measures to Australia and notify them to the TBT Committee or other relevant WTO committee. Australia welcomed the opportunity to comment on any new measures and would be seeking to ensure that any measures regarding coal quality standards or testing were consistent with WTO rules and were non-discriminatory, applying to all imports as well as domestically produced coal. He noted that both China and Australia were signatories to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) and that under this

agreement, coal could be tested prior to leaving Australian ports. Australian testing facilities were equipped to accurately test against China's coal quality standards and Australian coal was exceeding

these high standards. Australia encouraged China to accept coal test results by independent test laboratories in Australia, as other coal importing countries did. Australia looked forward to continuing dialogue with China to ensure that legitimate environmental policy objectives could be met through WTO-consistent measures, which were not more trade restrictive than necessary.

3.173. The representative of China said that since the entry into force of the Interim Measures for

Quality Management of Commercial Coal in 2015, both imported coal and domestic coal were treated equally. For inspection, both Chinese and international methods could be adopted and the consistency of inspection method ensured the consistency of results. According to China's laws and regulations, the imported goods were subject to the inspection of China's Entry-Exit Inspection and Quarantine Bureau. The statutory inspection could not be replaced by third-party inspection. The goods in bulk needed to be inspected at port of unloading and statutory inspection in the port of entry could not be replaced by pre-shipment inspection.

3.4.27 India — The Stainless Steel Products (Quality Control) Order, 2015,

G/TBT/N/IND/50 (IMS ID 48671)

3.174. The representative of the European Union raised concerns on India's Stainless Steel Products (Quality Control) Order, 2015. The full statement is contained in G/TBT/W/635.

3.175. The representative of India provided responses to the concerns raised. The full statement in contained in G/TBT/W/623.

3.4.28 India — Draft Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2015, G/TBT/N/IND/51, G/SPS/N/IND/119 (IMS ID 49472)

3.176. The representative of the European Union reiterated its concerns regarding the measure. The EU welcomed the publication of the regulation on additives for alcoholic beverages in the Gazette in August 2017, although she said that not all their concerns had been taken on board. The regulation had been published in April 2018. Enforcement of the regulation published in April 2018 would start

in April 2019. She said that while the regulation answered some of the concerns raised by the EU,

some issues of concern remained. The EU recalled transparency obligations contained in the TBT Agreement, pointing out that the list of food additives permitted in alcoholic beverages adopted by the competent Indian authorities had been notified to WTO on 22 September 2016, but only via the SPS notification system. India was invited to notify the regulation also to the TBT Committee and to allow a reasonable time for comments before entry into force.

3.177. Whilst India had taken most comments into account, her delegation requested that the lack of stock-exhaustion clause be addressed so as to allow the sale of products already present on the

Indian market until exhaustion of stocks in order to minimize the impact for economic operators. Also still of concern was the presence of some technical specifications (e.g.: maximum alcohol content, sugar content) that in the EU's view may not be in line with international standards or with international widely accepted practices and could adversely impact international trade, preventing some EU wines, spirits or beers from entering the Indian market. Some labelling requirements were

considered excessive (e.g.: residues of additives in the final product) and could potentially trigger

71 For previous statements follow the thread under IMS ID 486 (under dates raised and references). 72 For previous statements follow the thread under IMS ID 494 (under dates raised and references).

Page 30: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 30 -

additional technical controls that might result in unjustified barriers to trade. Finally, she said that the regulation also included the need to satisfy excessive analytical parameters that would result in additional technical controls (residual extracts, higher alcohol, iron …), which might once again result in unjustified barriers to trade.

3.178. The representative of Jamaica noted the implementation of the revised Indian standard for alcoholic beverages had come into force on 1 April 2019 and which provided for a specification for

rum. He said that the Caribbean was widely regarded as the region where the product distilled from sugar cane materials (juice, syrup or molasses) had first come to be known as "rum". The Caribbean had a long tradition of rum production from sugar cane-based raw materials. Jamaica applauded the efforts of the Indian authorities to improve several aspects of the standard. It was noted that the standard provided for age statements to reflect the youngest spirit in the blend and that the only colouring must be obtained from caramel. His delegation considered these to be important

international practices deserving endorsement.

3.179. However, Jamaica pointed out that internationally, rum was recognized as the product obtained from the fermentation and distillation of sugarcane materials – fresh cane juice, syrup, molasses. This understanding was clearly outlined in the Harmonised System agreed by members of the World Customs Organisation and in virtually all beverage alcohol standards around the world. In this sense the Indian specification which said "rum…may also be prepared from neutral, rectified, distilled spirit of agricultural origin", would appear to be at variance with international practice and

conventions. Due to cost advantages afforded by non-specific raw materials, the permission granted by these provisions may inadvertently result in an unfair advantage to Indian producers in the national market and potentially in international commerce. Internationally the product "rum" was widely understood to originate from a sugarcane distillate and to use any other raw material may give rise to the perception of consumer deception. Jamaica was encouraged by the steps being taken by India and urged the Indian government to re-examine its regulation with a view to enhancing the transparency element of the regulation and the authentic specification for the product "rum".

3.180. The representative of India provided responses to the concerns raised. The full statement in contained in G/TBT/W/620.

3.4.29 China — Formula Registration Regulation for Infant and Follow-up Formula, G/TBT/N/CHN/1165 (IMS ID 49373)

3.181. The representative of the United States supported other Members' previous interventions on this issue. The United States remained concerned with regard to implementation requirements for

registration of infant formula. The US looked forward to receiving an update on the measures, as had been indicated by China at the previous TBT Committee meeting.

3.182. The representative of Switzerland supported the previous comments made by other Members. While Switzerland shared and supported China's desire to protect public health, there were concerns about the impact these measures might have on trade. A number of issues still remained unclear in relation to the registration process of new infant and follow-up formulae,

particularly circumstances under which inspections were needed to achieve the legitimate objectives

pursued. Establishments in Switzerland operated under mandatory self-controls and official controls by the competent Swiss authorities. Inspections by the competent Chinese authorities should be limited to cases where significant changes to the production were made. Switzerland welcomed China's engagement with Members to avoid unnecessary obstacles to trade and thanked China for the bilateral exchanges and looked forward to further cooperation.

3.183. The representative of China provided further information on the measure. In 2016, the Formula Registration Regulations for Infant and Follow-up Formula Milk Powder had been issued. In

2017, the guidelines to implement the regulation (CFDA175) had been issued: Application Documents and Requirements for the Formula Registration of Infant Formula Milk Powder; and Site Checklist and Criteria for the Formula Registration of Infant Formula Milk Powder. She said that both domestic and foreign companies were treated equally.

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

Page 31: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 31 -

3.4.30 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 50574)

3.184. The representative of the European Union noted that the recent Decree no 44/2019 of 15 January 2019 extended the coverage of the mandatory registration of importers established by two ministerial Decrees (No. 991/2015 and 43) to four new product groups. However, this decree had been notified to the TBT Committee only after its adoption on 14 February 2019, and WTO Members

had not had an opportunity to submit their comments. The EU appreciated the exchange of information in the TBT Committee concerning the state-of-play of the registration of EU companies. Nevertheless, EU industry and especially small and medium-sized companies, continued to report serious difficulties with regard to the duplication of procedures and, in particular, long delays in the registration process. She stated that ceramic sector companies were particularly affected. The EU requested that all the companies which submitted complete documentation be registered without

further delay. The EU also requested that Egypt provide a list of EU companies to which registration

had been refused. The EU reiterated its invitation to Egypt to suspend or substantially improve the registration process and recalled the details provided in the EU's previous statements of the past TBT Committees. Finally, the EU invited the Egyptian authorities to inform the Committee on the steps taken to facilitate compliance with the registration requirements by companies.

3.185. The representative of Brazil shared concerns expressed by the EU and reported that certain Brazilian companies of tableware glass and ceramic articles, cosmetics, and food products had

reported serious difficulties stemming from long delays in the registration process, in some cases extending for almost two years. Brazil said that requirements established by Decree 43/2016 for manufacturer registration were adding costs and creating unnecessary obstacles to trade and were not in line with commitments under the TBT Agreement. Furthermore, significant decreases in exports of affected Brazilian goods to Egypt had also been reported. He noted that Brazilian authorities had been in continuous contact with Egyptian authorities in Cairo and in Geneva to express these concerns, which were preventing bilateral trade from growing and diversifying. This

situation was particularly worrying given the fact that the Mercosur-Egypt FTA was already in force

since September 2017. Brazil requested Egyptian authorities to implement changes to simplify the registration requirements established by Decree 43/2016.

3.186. The representative of Thailand reiterated interest in this measure and recalled that last year Thailand joined other Members to encourage Egypt to facilitate the registration process in a transparent and timely manner in order to avoid disruption. However, several Thai companies were

currently still awaiting final approval, despite submitting applications and documents to the General Organization for Export and Import Control (GOEIC) in 2016. Despite communication with competent authorities, no responses had been provided in this regard. Thailand appreciated good cooperation and bilateral meeting in the past with Egypt and welcomed any further progress in this matter.

3.187. The representative of Egypt appreciated requests from a few delegations for bilateral meetings on this matter; she believed that useful and fruitful bilateral exchanges among Members was the only way to clear misunderstandings and reach resolutions. Egypt had asserted in a number

of previous Committee meetings that Decree 43 had been adopted as a tool for market surveillance

solely, and that no restriction on trade had resulted from it. She said this argument was strongly supported by the fact that Egypt's imports in 2017 had witnessed an increase of almost 14% compared to the previous year. Similarly, the period January-October 2018 had witnessed more than 19% increase in trade to reach 57.7 billion USD compared to 48.5 billion USD in the same period of 2017. As highlighted during previous meetings, Egypt reiterated that the sole purpose of Decree 43 was monitoring the Egyptian market and protecting Egyptian consumers from

counterfeited products, and that full consideration had been given to ensure Decree 43 was not more trade restrictive than necessary. In addition, Egypt said full consideration had been given to ensuring the simplicity of the required documentation and procedures so that no extra burden would be imposed on trading partners, and that the confidentiality of data provided by companies was preserved. Egypt noted that no application from a company had been rejected to date. She noted all the comments and concerns raised and urged Members to convey problems faced by their

companies with registration, so that her delegation could investigate the means of addressing these problems.

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

Page 32: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 32 -

3.4.31 Ireland — Public Health (Alcohol) Bill 2015, G/TBT/N/IRL/2 (IMS ID 51675)

3.188. The representative of Argentina reiterated his delegation's concerns regarding the Republic of Ireland's Public Health (Alcohol) Bill, adopted in 2018, which established additional labelling and marketing specifications and in particular the inclusion on labels of warnings concerning the direct connection between alcohol and fatal cancer. Argentina referred to the comments and objections made at previous meetings, in which Argentina had highlighted the importance of adopting

appropriate measures to protect human health without creating an unnecessary barrier to international trade.76 Bearing in mind that the Public Health Bill had been promulgated in October 2018, Argentina requested the European Union to indicate what evaluations had been carried out regarding this measure and, in particular, whether Ireland had made the corresponding notifications to the Commission through the Technical Regulations Information System (TRIS). Ireland was also requested to provide a tentative schedule for the implementation of this Bill and the EU Commission

was requested to notify this measure and ensure its consistency with all applicable WTO obligations.

3.189. The representative of the United States supported Ireland's objective of managing the public health challenges of excessive alcohol consumption. At the November 2018 TBT Committee meeting the United States had repeated its request for Ireland to notify the amendments made to its Public Health (Alcohol) Bill 2015. At that meeting Ireland had indicated that, due to public health concerns, it had been forced to enact the bill as soon as possible. Ireland further indicated in November that the labelling provisions would require secondary legislation that these would need to be notified

(first) to the European Commission and that Ireland would then notify these provisions to the WTO TBT Committee. Also, Ireland had confirmed at the November 2018 meeting that the secondary legislation and the primary law would not become operational for three years. The United States asked if Ireland could clarify its regulatory process for the forthcoming secondary legislation, and provide an expected timeline for notification to the TBT Committee. As the US had previously noted, there was concern about the impact of labelling provisions on US producers, including on their ability to reallocate products in the EU's internal market. Would Ireland continue to accept product that

had already been labelled for other EU markets? Alternatively, was Ireland proposing that producers

would have to re-label any product that first entered another EU member State that they subsequently wished to send to Ireland for sale?

3.190. The representative of New Zealand supported Ireland's right to introduce new regulations to address legitimate public health objectives and noted the EU response that the proposed labelling and health warning provisions of Ireland's Public Health Alcohol bill 2015 had not been implemented

by Ireland on the passing of the bill domestically on 17 September 2018, and that, at the date of the November 2018 Committee meeting, these proposed measures for labelling and health warnings on alcohol were still to be submitted by Ireland to the European Commission for consideration before implementation. New Zealand recalled that the EU had advised the Committee in November 2018 that once these labelling and health warning measures were submitted to the European Commission by Ireland, the EU would notify these measures to the Committee. New Zealand requested an update on the status of proposed health and warning label measures for alcohol to be sold in Ireland. New

Zealand also requested that the Committee be advised of the expected date that the proposed health and warning label measures for alcohol to be sold in Ireland would be notified to WTO Members, and

when the content of the proposed measures would be available for review.

3.191. The representative of Mexico thanked the EU for the bilateral discussions and reiterated its request to Ireland and the EU to notify as soon as possible the secondary legislation that the Ministry of Health was planning for this law and allow for a time-frame for this to be reviewed.

3.192. The representative of Australia recognized the right of governments to take measures

necessary to protect public health and appreciated the Republic of Ireland's efforts to address a legitimate public health concern. It was noted that Australia was currently reviewing responses provided by the EU to Australia's comments. Noting that the implementation time frames for 23 of 31 sections the Public Health (Alcohol) Act 2018, Australia sought clarification on the details and implementation of the remaining eight sections, in particular Section 12 on Labelling. Australia also sought clarification on the process with regards to clearance at EU level. Australia asked for advice

on the expected timing for implementation of the new requirements and welcomed the information that policy implementation would include a transition period to enable businesses time to prepare

75 For previous statements follow the thread under IMS ID 516 (under dates raised and references). 76 G/TBT/M/76, para. 3.133.

Page 33: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 33 -

for the new requirements. Australia also welcomed clarification as to whether alcohol importers and exporters had participated in consultations on the impact of the requirements and sought further clarification as to the evidence on which the draft legislation and labelling requirements had been based, and how the proposed measures would contribute to public health objectives. Noting that significant amendments had been made to the Act since it had been notified to the WTO, Australia encouraged Ireland to re-notify the new Act through a TBT notification procedure, to allow trading

partners to comment on the revised proposal.

3.193. The representative of Chile supported the interventions made by other delegations.

3.194. The representative of the European Union thanked delegations for their statements on the Irish "Public Health (Alcohol) Bill 2015" notified to the TBT Committee on 9 June 2016 under G/TBT/N/IRL/2. As had been mentioned at the previous TBT Committee meeting77, because of the severe public health implications of this issue, the Government of Ireland had been obliged to enact

the primary legislation at the earliest possible date. The Bill had been signed into law on 17 October 2018 and a copy was available online.78 The labelling provisions of Health Bill required secondary legislation; these implementing regulations would have to be notified to the European Commission under Regulation (EU) 1169/2011 and would also be notified to the TBT Committee. It was noted that the three-year lead-in time before the provision became operational would not commence until the notification processes at EU and WTO level had been completed to allow businesses the full three years to prepare for and to make the necessary changes to comply with the new measures. With

respect to comments received from WTO Members under the WTO TBT notification procedure, these had been examined and replies had been sent to relevant Members the previous week.

3.4.32 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 52179)

3.195. The representative of the European Union raised concerns regarding measures adopted by the Russian Federation introducing certification requirements for medicinal products. The full statement is contained in G/TBT/W/636.

3.196. The representative of Ukraine echoed the concerns raised by the EU and registered her delegation's interest in the issue.

3.197. The representative of the Russian Federation informed the Committee that the System of

Good Manufacturing Practice for pharmaceutical products was fully based on international standards and recommendations in this sphere. On the concern regarding lack of inspection capacities in the Russian Federation, also raised previously, he reported that during the period from 2016 to 2018 inspection capacities had increased four-fold. 85% of inspectors were responsible for conducting inspections abroad and these regularly participated in experience-sharing activities with their foreign counterparts and advanced training courses including those approved by the WHO. For the period

2016-2018, the Ministry of Industry and Trade of the Russian Federation had received 2,110

applications for GMP certification from foreign entities, 1,452 inspections were conducted, 1,393 inspection reports were submitted to the Ministry of Industry and Trade, 1,007 foreign entities were certified and 410 applications were declined.

3.198. He also noted that in accordance with paragraph 16 of the Rules of Good Manufacturing Practice, if the period of validity of the issued certificate or the location of manufacturer or scope of pharmaceutical products manufactured on that production site were changed, the authorized body had the opportunity to decide whether to issue the certificate without re-inspection. Recently passed

legislation, specifically the amendments to the Federal Law "On the circulation of medicines" that had entered into force on 15 June 2018, allowed parallel conduction of GMP inspections and registration of pharmaceutical products. New rules significantly reduced the period for release of

77 G/TBT/M/76, para. 3.139. 78 http://www.irishstatutebook.ie/eli/2018/act/24/enacted/en/html. 79 For previous statements follow the thread under IMS ID 521 (under dates raised and references).

Page 34: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 34 -

pharmaceutical products. Russia remained open to consideration of all comments and questions on the issue and to engage in constructive dialogue with WTO Members.

3.4.33 China — Cybersecurity Law (IMS ID 52680)

The representative of Japan reiterated previously raised concerns81 and requested China to provide information on the situation of "Security Assessment Measures for Cross-Border Transfer of Personal Information and Important Data", which was subject to public comment in April 2017 and

was scheduled to enter into force from the end of last year.

3.200. The representative of the European Union reiterated previously raised concerns.82 The full statement is contained in G/TBT/W/637.

3.201. The representative of the Republic of Korea supported the concerns raised by other Members

and reiterated previously raised concerns, particularly regarding the need to clarify the meaning of "high level of safety risks". It was also noted that since the implementation of the Cyber Security

Law on 1 June 2017, Korean companies were having difficulties complying with the law, as the specific content such as the relevant decree, rule, and standard had not yet been announced. As a result, China was requested to provide a timeline of the announcement and enforcement, and further, to publish a security assessment guideline, containing detailed examples and case studies of "data with high level of safety risks". In addition, China was urged to provide a grace period of at least six months after the announcement of the final document since exporting companies needed reasonable time to comply with the regulation.

3.202. The representative of the United States referred the Committee back to its previous statement delivered in November 2018.83

3.203. The representative of Australia supported the concerns raised by other Members and reiterated previously raised concerns regarding China's Cyber Security Law and related laws

including the recent draft Provisions on Internet Security Supervision and Inspection.84

3.204. The representative of China said the Cyber Security Law was a fundamental and framework law in the field of China’s cyber security, which had marked a milestone in the history of national

cyber security cause. The release and implementation of the Cyber security law was aimed not only at protecting the interest of those using cyber space and effectively safeguard national sovereignty and security in cyber space by legal means, but also to promote the application of information technology and put into play the huge potential of the internet. Opening up would remain the basic policy of China and would continue to become even more open. It was a principle that China would continue to open to the outside world and maintain cyber security in an open environment. The

purpose of the law was to safeguard national sovereignty in cyber space, national security and public interest, and protect the rights and interests of citizens, legal persons and other organizations in China. It was by no means meant to restrict market access of foreign enterprises, technologies and products in China, nor would it restrain the orderly, free flow of the data in accordance with the law.

3.4.34 European Union — Organic production and labelling - Maté (erva-mate) (IMS ID 52485)

3.205. The representative of Brazil recalled concerns raised at previous meetings.86 Brazil welcomed

that EU Regulation 2018/848 now included "erva mate" in its list of organic products. Brazil, however, was still concerned with the long waiting period until the date this measure would enter into effect on 1 January 2021. During this period Brazilian "erva mate" producers would not be able to have access EU organic labelling, as provided under this regulation. He recalled that in previous meetings Brazil had argued that not including "erva-mate" in the organic product list without any technical or scientific justification was discriminatory and more trade-restrictive than necessary, and

80 For previous statements follow the thread under IMS ID 526 (under dates raised and references). 81 G/TBT/M/76, para. 3.153; G/TBT/M/75, para. 4.172 and G/TBT/M/74, para. 2.196. 82 G/TBT/M/76, para. 3.155 and the full statement contained in G/TBT/W/509. 83 G/TBT/M/76, para. 3.156. 84 G/TBT/M/76, para. 3.157 and G/TBT/M/75, para. 4.175. 85 For previous statements follow the thread under IMS ID 524 (under dates raised and references). 86 G/TBT/M/76, para. 3.159; and G/TBT/M/75, para. 4.177.

Page 35: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 35 -

thus inconsistent with Articles 2.1 and 2.2 of the TBT Agreement. The approval of EU Regulation 2018/848 without any transitional measures for allowing "erva-mate" to enjoy organic labelling as soon as possible - rather than waiting until January 2021 - seemed to indicate, in Brazil's view, that the EU had not taken into consideration its early arguments about possible inconsistencies of this EU Regulation with certain TBT Agreement provisions.

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

TBT Committee meeting.87

3.4.35 European Union — Regulation (EC) No 1107/2009 - non-renewal of approval of the active substance picoxystrobin G/TBT/N/EU/437 (IMS ID 53588)

3.207. The representative of Brazil raised concerns regarding the European Union's regulation on the non-renewal of approval of the active substance picoxystrobin. The full statement is contained

in G/TBT/W/624.

3.208. The representative of Canada said that picoxystrobin was a key active substance used for grain and oilseed production in Canada. A growing number of active substances were not being renewed in the European Union due to incomplete or insufficient information to complete a risk assessment and exclude health and environmental concerns. However, given that picoxystrobin was approved in 65 countries, Canada encouraged the EU to indicate what information was needed to complete and conclude its risk assessment.

3.209. The representative of Panama supported Canada's intervention and reiterated his

delegation's previous concern that this EU measure constituted an unnecessary barrier to trade. As a tropical country, Panama depended on the use of these types of active substances in order to protect itself from fungi, from insects and other items that were not present in the EU.

3.210. The representative of Paraguay reiterated her delegation's previous concern with the EU

decision not to renew the approval of picoxystrobin because the EU had not based this decision on scientific criteria, ignored international consensus, and the opinion of specialized agencies on non-toxicity in the use of these substances. This decision, as well as the new MRLs for this substance

notified to the SPS Committee, would have a negative impact on Paraguayan exporters by restricting trade unnecessarily. She noted that at the last SPS Committee meeting, 15 Members had also expressed concerned with these new MRLs established by the EU. In her delegation's view in this other body, showed that these EU measures could adversely affect several WTO Members. Despite these many expressions of concern, the EU had nonetheless decided to approve the amendment of the MRLs for this substance in January 2019, as notified in G/SPS/N/EU/264/Add.1.

3.211. The representative of Colombia expressed her delegation's interest in following these topics and discussions, as they progress both at the TBT and SPS Committees.

3.212. The representative of the European Union reiterated responses provided at previous

TBT Committee meetings.89 He provided a further update on the draft measure lowering the MRLs for picoxystrobin to the limit of quantification (LOQ), which was prepared and presented to the Standing Committee on Plants, Animals, Food and Feed. The EU had notified third countries of the draft Regulation via the SPS procedure. Comments received from non-EU countries and stakeholders

were available to the Standing Committee, where a summary of the key points raised had been presented. The Standing Committee had given a favourable opinion on the draft. The European Commission had formally adopted the revised MRLs in January 2019. The revised MRLs were set to apply as from 13 August 2019. The EU also clarified that import tolerance requests however remained possible and would be assessed on a case-by-case basis by EFSA. Such requests would have to be supported by substantial new data addressing the concerns.

87 G/TBT/M/76, para. 3.160. 88 For previous statements follow the thread under IMS ID 535 (under dates raised and references). 89 G/TBT/M/76, para. 3.176 and G/TBT/M/75, para. 4.188.

Page 36: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 36 -

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

3.213. The representative of the United States reiterated concerns raised in the previous TBT Committee meeting.91

3.214. The representative of the Republic of Korea reiterated concerns raised at the previous TBT Committee meeting92 and requested sufficient scientific evidence for this measure. Korea noted that

this measure was inconsistent with Codex guidelines and principles. This requirement, which was not based on scientific risk assessment was more trade restrictive than necessary. Given the short transitional period until its entry into force in October 2019, China was asked to share the revised draft measures reflecting WTO Members' comments in a timely manner.

3.215. The representative of Guatemala thanked China for its willingness to change the date of

entry into force of the measure to October 2019, giving the industry the necessary time to adapt to

the new measures. However, she sought confirmation that the certification requirement had been eliminated. She also requested more clarity about the new structure in the customs office, corresponding to the changes to be made in the regulations. She asked whether China would notify the new structure and processes.

3.216. The representative of Mexico said that her delegation followed with great interest the developments regarding China's certificates. She thanked China for the bilateral meetings, which had taken place over the previous few days and looked forward to receiving responses.

3.217. The representative of China thanked delegations for their comments, which were very useful for understanding trade partners' thoughts and assess effects of the proposed regulation. As explained on various occasions, the objective of the regulation was not to restrict trade, but to ensure safety and improve traceability through strengthening supervision responsibilities of exporting parties' authorities. China was still considering the many comments received from

Members following the notification of the draft. While a final decision had not been reached, he reassured Members that the measure would not affect existing trade after October, even when

Members could not provide certificates for processed food, until a mutually agreed solution was found.

3.4.37 Viet Nam — Decree on the regulation on conditions for automobiles manufacturing, assembling importing and automotive warranty & maintenance services (IMS ID 54993)

3.218. The representative of Thailand reiterated previously raised concerns regarding the requirements contained in Decree 116.94 The lot-by-lot testing requirements for imported vehicles

would be especially onerous for Thailand's automobile exporters adding additional testing costs and serious delays in imports. Viet Nam had stated at the previous meeting that automobile enterprises had been consulted and that imports had since recovered. However, testing for imported cars still had to be conducted lot-by-lot which differed from Vietnamese domestic cars. There was evidence

that Thailand's car export rate to Viet Nam had decreased by 10%. Moreover, it took two months more to complete the importation process into Viet Nam compared with prior to entry into force of Decree 116. In order to remove this technical barrier to trade, Thailand requested that Viet Nam

revise the lot-by-lot testing requirements, to test only once, applying the results to all cars covered by the same production series, and to accept the VTA certificate conducted by exporting countries without additional conditions. Thailand was monitoring Viet Nam's automobile regulations closely and was aware that Viet Nam was going to adopt a new circular on the technical safety, quality inspection and environmental protection in manufacturing and assembling motor vehicles including the auto parts; which would enter into force in April 2019. He asked that Viet Nam notify the referred draft circular, circular No.03 and any implementing circulars for Decree 116 to the Committee so

90 For previous statements follow the thread under IMS ID 547 (under dates raised and references). 91 G/TBT/M/76, para. 3.185. 92 G/TBT/M/76, para. 3.182. 93 For previous statements follow the thread under IMS ID 549 (under dates raised and references). 94 G/TBT/M/76, para. 3.203.

Page 37: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 37 -

that Members could comment and allow time for industry to become acquainted with the new requirements.

3.219. The representative of the European Union reiterated concerns raised at the previous TBT Committee meeting.95 In addition she raised concerns with a new circular within the framework of Decree 116 where Viet Nam was also considering no longer allowing for the recognition of UN certificates for car parts and would require all imports to undergo local testing. This was clearly

against the EU-Viet Nam Free Trade Agreement. Viet Nam should recognize EU parts and equipment complying with UN regulations without further testing and certification. The same should apply to passenger cars.

3.220. The representative of the United States reiterated the concerns raised in the previous TBT Committee meeting.96

3.221. The representative of Japan shared the concerns raised by other Members regarding Decree

116. According to the Decree, imported automobiles were required to have a copy of vehicle type approval issued by overseas authorized agencies. Domestic automobiles were only required to have vehicle type approval issued by Vietnamese authorities. Imported automobiles were subject to inspections in each shipment. Japan requested that Viet Nam treat imported automobiles and domestic automobiles in an equitable manner.

3.222. The representative of Viet Nam informed the Committee that under the Law on Investment enacted in 2014, automobiles manufacturing, assembling, import and related services such as

guarantee and maintenance are business and investment operations and must meet prerequisite conditions for the sector. Automobile products required strict inspections to ensure they met quality standards as they posed a high risk to people's safety and the environment. Government Decree 116 2017 ensured technical safety and environment protection while upholding customers rights on the basis of the fair competition principle. According to Vietnamese customs statistics, automobiles from different originating markets had been imported into Viet Nam. Feedback from importer

representatives had been that the process took time to get acquainted with and adjust to

successfully, including the VTA and lot-by-lot inspections. Examination of complaints by importers concluded that compliance was not too complicated or costly. The lot-by-lot testing on imported automobiles had been carried out in accordance with Circular No. 3 2018, guiding implementation of Decree 116 2017. It was one of the quality control measures applied in accordance with Viet Nam's Law on Goods Quality in Compliance with International Standards and Practice. This was the most appropriate when product manufacturing process could not be controlled. The testing fee was

based on actual costs of services. The fee construction methodology was popular in the ASEAN region and the fee much lower than in developed countries, due to lower labour costs. Testing times mostly depended on how well importers or manufacturers made the sample ready for testing in accordance with clear guidance.

3.4.38 Viet Nam — Cybersecurity Measures (IMS ID 54497)

3.223. The representative of Japan reiterated previously raised concerns regarding Viet Nam's

Cybersecurity Law, and noted that at the last meeting, Japan had requested that Viet Nam notify

the Decree to the TBT Committee and to consider comments from Members. The Decree had not yet been notified even though the draft Decree had indicated the date of entry into force on 1 January 2019. Japan therefore requested Viet Nam to provide updated information on the status of entry into force of both the Cybersecurity Law and its Decree as it would be regrettable if the Decree came into force without TBT notification. Japan also requested Viet Nam to provide the details of the term "cybersecurity condition" and the procedures in legal forms. Moreover, Japan remained concerned with the entities that would be obliged to comply with the requirement to store data locally and to

open up a branch or a representative office in Viet Nam as stipulated in articles 24 and 25 of the Decree.

3.224. The representative of the United States98 stated that her delegation was disappointed that Viet Nam had failed to formally notify the Law to the WTO while still in draft form. The US requested

95 G/TBT/M/76, para. 3.205. 96 G/TBT/M/76, para. 3.206. 97 For previous statements follow the thread under IMS ID 544 (under dates raised and references). 98 G/TBT/M/76, para. 3.211.

Page 38: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 38 -

Viet Nam to notify the Law and the draft implementing measures that were published on 2 November 2018 and to allow all interested parties to provide input. Moreover, Viet Nam was asked to consider using a risk-based approach to cybersecurity that drew from industry best practices, widely accepted definitions, and international standards, including the Common Criteria Recognition Arrangement (CCRA) certification process when finalizing the draft implementing measures for the Law.

3.225. The representative of the European Union supported the concerns raised by other Members

and recalled previously raised concerns regarding the potential economic impact of that legislation and the compatibility with Viet Nam's commitments under the WTO.99 Her delegation welcomed public consultations on the Draft Implementing Decree on Cybersecurity that had allowed the European Commission and the European External Action Service to provide to the Vietnamese authorities comments on the draft legislation. According to recent information, the implementing decree, which set out further details for some articles of the Cyber Security law, had not yet been

adopted and therefore her delegation requested that Viet Nam notify the draft decree to the TBT

Committee for general transparency purposes and in accordance with Article 2.9 of the TBT Agreement. This notification would provide to WTO Members the opportunity to analyse the draft decree in depth and to provide comments within a reasonable time limit.

3.226. The representative of Canada also supported the concerns raised by other Members, noting the importance of WTO notifications as well as the use of international standards and conformity assessment schemes. Canada noted that common information technology products entering Viet

Nam were already subject to in-country testing even when international standards had been met.

3.227. The representative of Australia reiterated previously raised concerns100 and noted that this measure could affect Viet Nam's reputation as an open economy and impact its ability to benefit from the digital economy and Industry 4.0. Australia understood that Viet Nam was currently preparing a second draft of the decree implementing the new law and requested Viet Nam to provide a period for public consultation on the second draft.

3.228. The representative of Viet Nam responded that the Cyber Security Law had been adopted

by the national assembly on 12 June 2018 to ensure that activity in cyber space would not harm national security, social order and safety, legitimate rights of organizations and individuals. Viet Nam clarified that the law would provide a full and strict legal framework for authorities to effectively protect national security and at the same time, secure a safe and secure cyber space for the public, creating favourable conditions for domestic and foreign IT, telecommunications and internet enterprises to do business in Viet Nam. The representative of Viet Nam noted that Art. 10 of the

Cybersecurity Law set out conditions applied to national security, critical information systems and stated that information systems that belonged to the state agency in the area of critical national security and of confidential nature. She explained further that that article did not apply to systems that were not national security critical information systems, including information systems of domestic private sector and of enterprises from other countries investing in Viet Nam. In order for the Decree to guide implementation of the cyber security law, Viet Nam had already published the draft to enable all individual, organization and domestic and foreign enterprises to assess and give

comments. Finally, Viet Nam had taken into consideration all the comments and had worked with

foreign representative organizations and enterprises for continued improvement of the draft. The draft decree was expected to be finalized and submitted to the government at the end of March 2019.

99 G/TBT/M/76, para. 3.213. 100 G/TBT/M/76, para. 3.212.

Page 39: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 39 -

3.4.39 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 545101)

3.229. The representative of Australia reiterated previously raised concerns102 and requested China

to reconsider the measures, and to facilitate global environmental outcomes by allowing for commercially meaningful trade in quality recyclable inputs.

3.230. The representative of the United States reiterated previously raised concerns regarding China's import ban.103 The full statement is contained in G/TBT/W/610.

3.231. The representative of New Zealand reiterated previously raised concerns regarding the

inclusion of vanadium slag in China's catalogue of banned imports under that measure104 and

supported the concerns raised by other Members on the short comment timeframe and implementation period for the measure.

3.232. The representative of Canada supported the concerns raised by other Members and reiterated previously raised concerns regarding China's restrictions on solid waste.105 Canada encouraged China to consider other mechanisms to address the very specific problem of contaminated materials while ensuring that mutually beneficial trade could continue in a predictable manner.

3.233. The representative of China responded to concerns raised.106 The full statement is contained in G/TBT/W/618.

3.4.40 India — Amended regulation on toy imports, G/TBT/N/IND/68 (IMS ID 546107)

3.234. The representative of the United States reiterated previously raised concerns.108 The US understood that India may be replacing the existing measure with a new regulation that would apply to all toy producers, both domestic and foreign. The US would expect a revised measure to apply equally to both foreign and domestic producers by requiring compliance with the same testing

requirements. If India did proceed with this replacement, the US requested that India notify any new measures while still in draft form and ensure adequate time and opportunity for interested parties to review the draft, submit comments, and have those comments taken into account prior to finalizing the measure.

3.235. The representative of the European Union supported the comments made by the United States. The EU reiterated concerns regarding the obligation for toys imported into India to be tested

by a test laboratory accredited by NABL. He explained this was costly and time-consuming, especially for producers in exporting countries who were, as a result, obliged to duplicate testing with very limited or no added value in terms of safety. This third-party testing obligation 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 consider allowing conformance to the relevant international standards as an alternative to the BIS standards.

3.236. The EU also remained concerned with the implementation of the amended regulation. He reported difficulties and delays faced by international laboratories in getting accredited by NABL led to a situation in which the amended regulation corresponded to a de facto in-country testing requirement. The EU was aware that applications from foreign laboratories from outside India had

101 For previous statements follow the thread under IMS ID 545 (under dates raised and references). 102 G/TBT/M/76, para. 3.191. 103 G/TBT/M/76, para. 3.193 and the full statement contained in G/TBT/W/574. 104 G/TBT/M/76, para. 3.192; G/TBT/M/75, para. 4.193; and G/TBT/M/74, paras. 2.236-2.237. 105 G/TBT/M/76, para. 3.196. 106 G/TBT/M/76, para. 3.197 and full statement contained in G/TBT/W/579. 107 For previous statements follow the thread under IMS ID 546 (under dates raised and references). 108 G/TBT/M/76, para. 3.200 and G/TBT/M/75, paras. 4.205-4.206.

Page 40: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 40 -

been received by NABL but there was no certainty as to whether and when a final decision would be taken. In this context, the EU requested India to clarify the status of these applications and whether ILAC accredited laboratories situated anywhere in the world could receive NABL accreditation.

3.237. The representative of India repeated responses provided in previous TBT Committee meetings.109 On the question from the US on any new regulation, he said he would refer this back to capital for consideration.

3.4.41 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 555110)

3.238. The representative of Indonesia reiterated her delegation's concerns on the use of "Palm Oil Free" labelling by several food-producing companies in the EU. Food products with palm oil free

labelling had also been exported to other countries including Indonesia. This was of great concern

to Indonesia as the major CPO producer with exports to several countries including the EU.

3.239. "Palm Oil Free" labelling led to consumer confusion and misunderstanding on the impact of food products containing palm oil. Allowing food exporters to apply this labelling in the absence of scientific evidence created unfair and unnecessary barriers to trade. Indonesia encouraged the EU to be consistent with EU Regulation 1169 Chapter V Article 36 point 2, which stated that voluntary labelling should not mislead and be ambiguous for consumers and where necessary should be provided with scientific evidence. The EU did not allow food producers to educate consumers on

carotenes contained in palm oil due to the fact of the insufficient scientific evidence. This was contrary to the current situation where EU allowed food producers to use "Palm Oil Free" labelling without scientific justification. She emphasized the International Codex standards related to general food labelling (General Standard for the Labeling Of Prepackaged Foods CXS 1-1985), especially regarding the basic principles that labelling is not misleading and not related to other products that confuse consumers.

3.240. She urged the EU to apply the principle of non-discrimination on the treatment given to palm

oil compared to other vegetable oils (sunflower, soybean, rapeseed oil) and the importance of providing scientific evidence related to the impact of palm oil in food products on human health compared to other vegetable oils. So as to ensure consistency with the Article 2.1 of the TBT Agreement on non-discrimination and Articles 3.4 and 3.5 on measures by local governments and NGOs, Indonesia urged the EU to take necessary action to ensure that their NGOs and local governments applied measures consistent with the TBT Agreement.

3.241. The representative of Colombia reiterated concerns with the EU's regulations about the use of "Palm Oil Free" labelling. The full statement is contained in G/TBT/W/599.

3.242. The representative of Costa Rica reiterated previously raised concerns. Allowing for this additional labelling constituted a failure to comply with the principles and legitimate objectives of

the TBT Agreement.

3.243. The representative of Ecuador supported the concerns raised by Colombia and Indonesia on the practice of labelling food products "Palm Oil Free", thus generating a negative campaign against

this specific product, without any technical or scientific basis. This label was misleading as it gave consumers the impression that products with this label had nutritional or environmental properties that similar products did not. From a nutritional perspective, this label represented a negative and unfounded generalization implying that palm oil was somehow dangerous to one's health or nutritionally inferior to other similar vegetable oils. There was no scientific basis for such an implication and moreover, it was not included in the Annex to Regulation (EC) No. 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food, listing

permitted nutrition claims.

3.244. From an environmental perspective, the label implied that palm oil per se was less environmentally friendly or sustainable than other similar vegetable oils, without considering the

109 G/TBT/M/76, para. 3.202 and G/TBT/M/75, paras. 4.209-4.210. 110 For previous statements follow the thread under IMS ID 555 (under dates raised and references).

Page 41: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 41 -

specific conditions of African palm producing countries such as Ecuador, where palm oil was produced in a responsible and sustainable manner. Ecuador joined others in requesting that the EU improve how it regulated this type of negative labelling under its existing legislation. Anti-competitive private practices such as this were harmful to the palm oil industry, not only to exporters but also to European food producers who used this oil as an input, as well as European consumers who were being targeted by these marketing strategies.

3.245. The representative of Guatemala said that as a palm oil producer, Guatemala supported the concerns raised by other delegations. While this measure did not limit the use of palm oil, it did discourage its use, thereby discriminating against palm oil as opposed to other vegetable oils and, in particular, oils produced by the EU, putting palm oil at a disadvantage. In 2017, palm oil was Guatemala's sixth main export. These new measures would have a major impact on bilateral trade, as the EU was one of Guatemala's main trading partners in this product. The palm oil agro-industry

in Guatemala accounted for 28,000 direct jobs, particularly in rural areas, and 85,000 families within

the country benefited from its production.

3.246. The production sector was making the necessary efforts to generate sustainable production, implementing policies at the private sector level and estimating greenhouse gas (GHGs) emissions in palm oil production, thus demonstrating the commitment to these issues. Furthermore, Guatemala considered it necessary to differentiate between palm oil production and production conditions. Condemning the global production of palm oil and along with it the many families whose daily

livelihood depended on this crop was simply not an option. Guatemala reiterated its commitment to meeting the UN SDGs, and support for sustainable palm oil certification with a view to meeting the Millennium Goals.

3.247. The decision made by the Trilogue (European Commission, European Parliament and Council of Europe) and its final approval in 2019 was worrying, especially as some producing countries had requested a hearing with the presidents of these three bodies and had not yet received a positive reply in writing to have a space for dialogue. Guatemala was concerned by the negative impact of

these measures and the opacity of the process. Guatemala would continue to participate actively in the TBT Committee and in Brussels, with the aim of preventing the establishment of discriminatory measures, in accordance with the principles of the WTO.

3.248. The representative of Thailand shared the concerns raised by other delegations. He encouraged the EU to provide scientific justification for the use of "Palm Oil Free" labels and to ensure that this label would not be used to misguide consumers nor cause discrimination against

palm oil. Thailand would continue to monitor the development of this concern in the TBT Committee.

3.249. The representative of Malaysia said that her delegation shared the concerns raised on palm oil free labelling and would continue to monitor the development of this issue in this Committee.

3.250. The representative of Honduras reiterated its concern on this measure. Members had the legitimate right to protect human health but these measures must be compatible with the WTO Agreements and should not restrict trade in an unnecessary manner. Honduras was closely following

developments on this issue in the TBT Committee.

3.251. The representative of the European Union repeated responses provided in previous TBT Committee meetings.111 The statement "palm oil free" per se/alone was not considered as a nutrition claim within the meaning of Regulation (EC) No 1924/2006 on nutrition and health claims. EU member States were responsible for enforcing, monitoring and verifying that relevant EU food law requirements were fulfilled by food business operators.

3.4.42 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)

G/TBT/N/THA/524 (IMS ID 556112)

3.252. The representative of the European Union welcomed the notification by the Thai authorities, on 15 November 2018, of the Ministerial Regulation entitled "Liquor Importation Permission" (B.E.

111 G/TBT/M/76, para. 3.231; G/TBT/M/75, para. 4.256; G/TBT/M/74, para. 2.46 and full statement

contained in G/TBT/W/476. 112 For previous statements follow the thread under IMS ID 556 (under dates raised and references).

Page 42: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 42 -

2560 (2017)). The EU was currently examining the Regulation in detail, with a view to providing comments. The full statement is contained in G/TBT/W/638.

3.253. The representative of New Zealand acknowledged and supported Thailand's right to introduce new regulations to address specific public health concerns. New Zealand appreciated that in seeking to address the harmful use of alcohol, the technical regulation was directed toward achieving a legitimate public health objective. However, New Zealand exporters remained uncertain

on certification requirements. She asked that Thailand advise whether acceptance of other recognized industry certification, which achieved the objective of these measures, was being considered. New Zealand remained keen to work with the Thai Government to ensure New Zealand exporters met Thailand's objectives under these regulations through the least trade restrictive means.

3.254. The representative of Australia reiterated previously raised concerns.113

3.255. The representative of Mexico urged Thailand to clarify the issues raised and to notify any changes to the TBT Committee.

3.256. The representative of Thailand informed the Committee that the Excise Department, the responsible regulatory body, was in the process of revising the Ministerial Regulation on Liquor Importation Permission B.E. 2560 (2017) and related laws. This was to ensure that the liquor quality examination and analysis were suitable for Thai society and in line with international practice by gathering information and opinion from experts in various fields including international organizations

and embassies. As a result, progress might take some time to process properly and accurately. Thailand took note of all comments from members and would convey them to the regulatory authority in capital.

3.4.43 China — Chinese Environmental protection control standards for imported solid waste as raw materials (IMS ID 551114)

3.257. The representative of Australia reiterated previously raised concerns.115 A range of materials impacted by China's measures were valuable inputs to recycling supply chains rather than "waste".

Trade in these products allowed for the recovery of materials which could otherwise end up in landfill or the oceans.

3.258. The representative of China repeated responses provided in previous TBT Committee meetings.116

3.4.44 India — Testing and Certification of telegraph (The Indian telegraph (Amendment) Rules, 2017), G/TBT/N/IND/66 (IMS ID 558117)

3.259. The representative of the United States recalled concerns expressed at the November 2018 meeting with the provisions contained in rules governing telecommunications-related equipment.

Namely, the US was concerned that the proposed certification procedures would produce overlapping and conflicting testing requirements through the Telecommunications Engineering Center (TEC) and under the Compulsory Registration Order (CRO) that were expected to result in unnecessarily burdensome costs for foreign companies selling telecommunications equipment in the Indian market. The US recognized India's desire to ensure the integrity and security of the country's

communications network. However, the US urged India to reconsider implementing domestic testing requirements, and to continue following standard international best practices, including the acceptance of ILAC-accredited lab results. She reported that the TEC had announced that the enforcement date of the testing and certification requirements had been postponed with no new date of enforcement having been announced. The US asked if India could confirm the postponement and

113 G/TBT/M/76, paras. 3.241-3.242. 114 For previous statements follow the thread under IMS ID 551 (under dates raised and references). 115 G/TBT/M/76, para. 3.245. 116 G/TBT/M/76, para. 3.248 and G/TBT/W/580. 117 For previous statements follow the thread under IMS ID 558 (under dates raised and references).

Page 43: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 43 -

asked if TEC would continue to accept test results from international ILAC accredited labs past the stated deadline of 31 March 2019.

3.260. The representative of India repeated the responses provided at previous TBT Committee meetings.118

3.4.45 United States — TSA Certification on security screening equipment G/TBT/N/USA/1132 (IMS ID 559119)

3.261. The representative of China raised concerns with the unequal treatment of Chinese companies in the conformity assessment procedure performed by TSA since 2018. Firstly, in the process of certification, TSA had failed to inform Chinese companies of the deficiencies and results in a precise and complete manner giving Chinese companies no chance to make corrections. This was not in compliance with Article 5.2.2 of the TBT Agreement. Secondly, China hoped that the US

would notify the TSA certification to the TBT Committee giving Members the opportunity to provide

comments, and thereby fulfilling the transparency requirements in TBT agreement. Thirdly, Article 5.1.2 stipulated conformity assessment procedures were not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. She said TSA certification was undertaken in an unpredictable, unclear manner, which had negative impacts on trade and created unnecessary obstacle to international trade. She hoped that the US would follow the relevant rules laid out in the TBT Agreement by notifying this certification, treating Chinese companies and products equally as domestic or other members', and not creating unnecessary

obstacles to trade.

3.262. The representative of the United States said that the only evidence provided by China had been related to government procurement which was not covered under the TBT Agreement. The US encouraged China to engage bilaterally as it was not a matter for discussion under the TBT Agreement.

3.4.46 Egypt — Halal requirements for Poultry Parts and Offal (IMS ID 571120)

3.263. The representative of the United States reiterated previously raised concerns.121 The US

noted that at the November 2018 meeting, Egypt had responded that it did not impose any restrictions on the importation of poultry. Egypt reported that under HS code 0207, US poultry exports to Egypt had increased 28 % in 2017 compared to 2016, and that there was an almost 3,500 % increase in 2017 compared to the average imports of the five preceding years. The US had conducted its own analysis but was unable to verify these figures and she therefore requested further information from Egypt on the data sources used for these claims. Also at the November meeting,

Egypt had cited challenges in verifying the source of all imported parts, the compliance of slaughtering houses, and difficulty in differentiating between poultry parts and raptors. However, she noted that Egypt's General Organization for Veterinary Services (GOVS) had inspected and confirmed that 22 US producers interested in exporting to Egypt conformed with Egyptian halal and food safety standards, including the traceability system. In light of the GOVS's existing verification, she requested Egypt to remove these unjustified barriers to trade.

3.264. The representative of Egypt thanked the US for the continuous interest and bilateral

exchanges on this issue, both in Geneva and at expert-level in capital. As underscored at the November 2018 meeting, the importance Egypt placed on halal requirements could not be emphasized enough. She said this position was fully justified by the structure and religious beliefs of Egyptian society. In addition, the rationale for Egypt's halal requirements had been explained at the previous meeting, and clarification had been provided on how these requirements were essential to safeguard the values and beliefs of Egyptian people, and consumer health. She emphasized that the requirements did not constitute any barrier to trade and were not applied in a discriminatory

manner. Finally, she reiterated that only whole poultry was considered to be in compliance with halal requirements upon the verification of the concerned authorities in Egypt. In response to the question from the US, she said the source of the trade data used was that notified to the Trade Map.

118 G/TBT/M/76, para. 3.257. 119 For previous statements follow the thread under IMS ID 559 (under dates raised and references). 120 For previous statements follow the thread under IMS ID 571 (under dates raised and references). 121 G/TBT/M/76, para. 3.26.

Page 44: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 44 -

3.4.47 Russian Federation — Federal law No 487-FZ, providing a framework for comprehensive use of special labelling and traceability of goods and Decision No. 792-r specifying the goods to which labelling will apply and the dates of introduction of the mandatory labelling (IMS ID 567122)

3.265. The representative of the European Union raised concerns on the Russian Federation's Decision № 792-r, listing goods which would be subject to mandatory marking, along with the dates

of introduction of these labelling requirements for each product category. The full statement is contained in G/TBT/W/639.

3.266. The representative of the Russian Federation reiterated that his delegation did not consider the Decision of the Government № 792-r to be a technical regulation since the decision did not meet relevant requirements stipulated in the TBT Agreement. He reiterated that the adopted measure had been elaborated to enhance the protection of sensitive products against counterfeiting and to ensure

the payment of all taxes. He stated that the measure fell under the purview of Article XX paragraph (d) of the GATT 1994. The Decision of the Government listed goods which would be subject to marking that would allow traceability of the product to tackle illicit trade. The traceability system had been developed in collaboration with and on the initiative of international companies including European ones. The measure would enter into force for tobacco products as of 1 July 2019, until which time tobacco producers and importers had to register in the system. For other products, timelines were currently being discussed between business and Government. Russia remained

available for constructive discussions on the issue.

3.4.48 Brazil — Technical Regulation 14, 8 February 2018, to set the additional official identity, quality standards for wine and derivatives of grape and wine products as well as the requirements to be acquainted and Technical Regulation No. 48, 31 August 2018 published in the Official Gazette on 10 September 2018, G/TBT/N/BRA/613 (IMS ID 568123)

3.267. The representative of the European Union noted that the EU wine industry exporting to Brazil

continued to be concerned about disruptions to trade due to the long list of analytical parameters

and their divergences with the OIV recommendations in Technical Regulation 14 of 8 February 2018, which set the additional official identity, quality standards for wine and derivatives of grape and wine products. The EU reiterated its invitation to the Brazilian authorities to make use, to the maximum extent possible, of the recommendations of the OIV when preparing its regulations on wine and to consider accepting imported wines made according to oenological practices authorised by the OIV. The EU was prepared to work bilaterally with Brazil regarding this issue.

3.268. The representative of New Zealand supported comments by the EU and encouraged Brazil to apply the international standards adopted by the OIV for testing requirements and certificates of analysis for wine imported into Brazil. The requirements for the certificate of analysis for wine exported to Brazil set out in Normative Instruction 14 (IN14) 2018 posed a significant barrier to trade for New Zealand wine exporters. Since parameters such as total sulphates expressed as potassium sulphate, total chlorides expressed as sodium chloride, ash and methyl alcohol were not required by other markets and were at variance with parameters set by the OIV, official laboratories

in New Zealand did not test for them. Considering Brazil's obligations under the TBT Agreement, New Zealand asked Brazil how it ensured that the certificate of analysis requirements were not more trade restrictive than necessary to achieve Brazil's objectives and what the rationale was for departures from conformity with OIV-adopted standards.

3.269. The representative of Brazil, recalling to the comments made in the previous TBT Committee meeting124, reaffirmed that neither this regulation nor any other Brazilian legislation concerning the wine sector represented an obstacle to exports of wine from the EU to Brazil. The EU was the biggest

seller of wine to Brazil, corresponding to around 40% of Brazil imports, ahead of Chile and Mercosur partners. The exports of wine to Brazil from the EU, Chile and Mercosur member states reached 367 million dollars in 2018, with 157 million dollars allocated to the EU, attesting to the openness of the Brazilian market and showing that Brazil did not impose unnecessary obstacles to trade and acted in a transparent manner regarding its commitments to developing regulations in this sector.

122 For previous statements follow the thread under IMS ID 567 (under dates raised and references). 123 For previous statements follow the thread under IMS ID 568 (under dates raised and references). 124 G/TBT/M/76, para. 3.16 and the full statement contained in G/TBT/W/561.

Page 45: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 45 -

3.5 Exchange of Experiences

3.5.1 Good Regulatory Practice

3.270. The Moderator's report is contained in G/TBT/GEN/256.

3.5.2 Conformity Assessment Procedures

3.271. The Moderator's report is contained in G/TBT/GEN/257.

3.272. The representatives of Canada and the European Union stressed the usefulness of sharing

experiences, and that this was an important way of hearing different perspectives. The moderator's summary was a very useful source of information to bring back to capitals. In addition, the European Union said that the discussion had been fully in line with what had been foreseen in the 8th Triennial

Review, in particular on conformity assessment. This would enable delegations to draw some general elements and principles regarding work on post-market controls which could be reflected in the future guidelines on which the Committee was about to start work.

3.273. The representative of South Africa, as one of the Members that had requested the session, said that the session had met all expectations. The information shared was very useful and would provide many valuable ideas that could be followed up on and implemented in capital.

3.5.3 Follow-up on Committee Decisions and Recommendations (G/TBT/41)

3.274. The Chairman said that delegations' key points arising during the Committee's informal discussions on follow-up to the 8th Triennial Review were contained in the "Aide-Memoire" document (JOB/TBT/273/Rev.2). This document was regularly updated by the Secretariat. In brief, based on

consultations, Members saw merit to begin follow-up work in two specific streams of work, namely

transparency and conformity assessment procedures.

3.275. On transparency, the Committee would hold a thematic session in June. It was proposed that this thematic session be webcast (as had been those reported on above) and that Committee dedicate one and a half days to the transparency thematic session (meaning that the thematic session would be extended from one day to one day and a half). Delegations so agreed.

3.276. On conformity assessment, the Chairman proposed that the Committee also use the June

meetings to start discussion on the topic of conformity assessment guidelines, without prejudice to any other areas of work that Members may wish to embark on in follow-up to the 8th Triennial Review, or in response to any past recommendations from previous triennial reviews (contained in G/TBT/1/Rev.13). In view of this, it was suggested that the Committee set aside time for a dedicated informal discussion during the June meeting week. In making this suggestion, the Chairman was mindful of the point made by some delegations at the February informal meeting that time was also

needed for bilaterals. The Chairman therefore suggested the following change in schedule for the

June meetings:

Mon, 17 June: No formal meeting (time left for bilaterals) Tue, 18 June: Dedicated informal on CAP guidelines (am), and

Thematic Session on transparency (pm) Wed, 19 June: Thematic Session Transparency (am and pm) Thu, 20 June: Regular meeting

Fri, 21 June: Regular meeting

3.277. It was so agreed.125

3.278. The Secretariat provided an update in respect of the validation of enquiry point information.126 The full statement is contained in document G/TBT/GEN/262.

125 The revised schedule of meetings for 2019 was subsequently circulated in JOB/TBT/262/Rev.1. 126 G/TBT/41, para. 6.19 (a.i).

Page 46: RESTRICTED G/TBT/M/77 - docs.wto.org · trade and public health. He said that tobacco use was a significant problem, in Canada and around the world. In Canada alone, 45,000 people

G/TBT/M/77

- 46 -

4 TWENTY-FOURTH ANNUAL REVIEW

4.1. The Secretariat introduced document G/TBT/42. The Committee took note of the Report.

5 TECHNICAL COOPERATION ACTIVITIES

5.1. A number of Members reported on technical assistance activities. The representative of Guatemala informed the Committee that a National Workshop on the TBT Agreement had taken place in December 2018 and the representative of the United States provided an updated on the

work of the Standards Alliance. The full statement is available in G/TBT/W/597. The representative of Chile thanked the WTO Secretariat for the 20-22 November 2018 workshop on ePing. Three seminars had taken place, with officials from the government, with industry, and in a regional setting – this was with the aim of increasing access and use of ePing. The activity had been valuable for all participants involved.

5.2. The Secretariat provided an update on technical assistance and on ePing. The full statement is

contained in document (G/TBT/GEN/262).

6 UPDATING BY OBSERVERS

6.1. The representatives of Codex, UNECE, OIML, UNIDO127, BIPM and IEC updated the Committee on TBT related activities.

6.2. The representative of ISO informed the Committee that revision of ISO guide 59, now called ISO IEC draft Guide 59 recommended practices for standardization by national bodies of ISO and IEC, was under way and WTO Members could comment on the draft guide during the enquiry stage

through the ISO and IEC members. This consultation stage was open until 15 March 2019. Following that, the joint working group members developing the guide would convene so as to address all comments received and agree on the next actions.

6.1 Pending requests

6.3. The representative of South Africa recalled his delegation's submission in the context of the 8th Triennial Review that the Committee was encouraged to make quick decisions on pending observer status requests. He urged delegations to consider these pending requests.

7 ELECTION OF THE CHAIRPERSON

7.1. This agenda item was suspended until the next formal meeting.

8 DATE OF NEXT MEETING

8.1. The next regular meeting of the Committee is scheduled for 20-21 June 2019. It will be

preceded by a dedicated informal meeting on approaches to conformity assessment procedures (18 June am) and the thematic session on transparency on 18 (pm) and 19 June.

__________

127 G/TBT/GEN/258, G/TBT/GEN/259, G/TBT/GEN/260, G/TBT/GEN/261.