G/TBT/M/66
- 1 -
minutes of the MEETING OF 17-18june 2015
CHAIRPERSON: ms alana lanza
Note by the Secretariat[1]
1 ADOPTION OF THE AGENDA
2 ELECTION OF THE CHAIRPERSON
3 IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT
3.1 Statements from Members under Article 15.2
3.2 Specific Trade Concerns
3.2.1 Withdrawn concerns
3.2.2 New Concerns
3.2.3 Previously Raised Concerns
4 Exchange of Experiences
4.1 SeventhTriennial Review
4.2 Status of Work on GRP (JOB/TBT/119/Rev.1)
4.3 TBT@20 Anniversary Event on 6 November 2015
5 TECHNICAL COOPERATION ACTIVITIES
6 UPDATING BY OBSERVERS
7 DATE OF NEXT MEETING
1ADOPTION OF THE AGENDA
1.1.The Committee adopted the agenda contained in WTO/AIR/TBT/2.
2ELECTION OF THE CHAIRPERSON
2.1.The Committee elected Ms Alana Lanza (Honduras) as the chairperson of the Committee.
3IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT
3.1Statements from Members under Article 15.2
3.1.The Chairperson reminded the Committee of Members' notification obligation under Article 15.2 of the TBT Agreement and further informed the Committee that the latest list of statements submitted under Article 15.2 of the TBT Agreement were contained in document G/TBT/GEN/1/Rev.14, issued 23 February 2015. She informed the Committee that in total, since the last meeting in March 2015, Ukraine and Sri Lanka had submitted revisions to their original statements. She further informed the Committee that since 1995, 129 Members had submitted at least one statement of implementation under the above-mentioned Article. Information on the list of statements was available, and regularly updated on the TBT Information Management System (
3.2Specific Trade Concerns
3.2.1Withdrawn concerns
3.2.The Chairperson reported that the following Specific Trade Concerns had been withdrawn from the Agenda at the request of the concerned Member:
- Chinese Taipei – Amendment to Legal Inspection of Toy Commodities- withdrawn by United States (New).
- Norway – The Regulation on Limitation in Use of Hazardous Chemicals- withdrawn by the Republic of Korea (New).
- United States- Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates- withdrawn by China (New).
- Ecuador- Draft Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No.47: Metal Cable Tray, electrical conduit and trunking systems- withdrawn by Mexico (New).
- European Union – Alternatives to Animal and New Cosmetic Regulations– withdrawn by Canada (Previously raised).
3.2.2New Concerns
3.2.2.1European Union - Proposed modification of Regulation (EC) 1829/2003 referring to genetically modified organisms,G/TBT/N/EU/284
3.3.The representative of Argentina said that, prior to this meeting his delegation had requested the European Union to notify this proposed regulation to the SPSCommittee, as the issue fell under the SPS Agreement. The proposed measure was however notified instead to the TBTCommittee. He said that Argentina was seriously concerned over this new proposed regulation, which intended to amend the current system for the authorization of GMOs, established in Regulation (EC) No.1829/2003, with a view to allowingEUmember states to restrict or prohibit the use of GMOs and genetically modified foodand feed in all, or only in parts, of their territory, although such use had been authorized by theEuropean Commission. He recalled that EU member states already had the possibility to prohibit and restrict, at national level, the marketing and importation of biotech products, provided that they produced scientific evidence that such products could pose a risk to health or the environment. However, the new proposal gave EU memberstates broad scope for discretion, which was inconsistent with the WTO rules, as they would now be able to unilaterally reject the authorizations approved by the European Commission under the current system, without having to provide any scientific proof. This would be a disguised discriminatory, arbitrary and unjustified restriction on international trade.
3.4.He said that according to the text of the proposed regulation, the prohibitions or restrictions applied by EU member states should be based on factors other than those identified in the risk assessment by the European Food Safety Authority (EFSA) for the authorization of GMOs, i.e., factors otherthan the risk to human and animal health, or to the environment. Argentina recalled that in the past, the EU and its member states had tried unsuccessfully to justify their restrictions on the use of GMOs using sciencebased arguments, which was why the issue was brought before a WTO Panel in 2003 (EC—Approval and Marketing of Biotech Products). This Panel found in 2006 that these restrictions were inconsistent with the SPSAgreement. In order to avoid further contentions being raised in the WTO and additional adverse rulings, theEuropean Commission appeared to be seeking, through the new proposed amendment to Regulation(EC) No. 1829/2003, alternative means of evading its international obligations under the SPS Agreement in thisregard. Argentina believed that the measures under the proposed regulation that would enable EU member states to restrict or prohibit GMOs were similarly incompatible with the WTO rules. This was so because this proposalwould create unnecessary obstacles to international trade and would lack proportionality in restricting trade more than what would be necessary to fulfil the objectives sought by the EU member states.
3.5.Argentina considered that if the proposal would be adopted, it would create a high level of unpredictability in international commodity markets by unjustifiably impacting not only producers in the EU, but also those in third countries. This proposed measure would also affect the integrity of the EU's single internal market and free transit within the EU. Although this could be attributed to a competition decision by the EU institutions, it would also adversely affect, either directly or indirectly, Argentina's exports to the EU. Argentina therefore requested the EU not to adopt the notified proposal and instead, to implement, in a timely and proper manner, the current EU legislation on the approval and authorization of the use of GMOs throughout the territory of the EU, thus bringing its regulations into line with theWTO rules.
3.6.The representative of Paraguay said that that this proposal would give EU member states the power to prohibit the use of genetically modified (GM) food and feed after these products have been authorized by the EuropeanCommission, including for those that had already been on the market. Many of these products, he said, had been used for a number of years in the European Union without any reports of negative effects to human or animal health or the environment. Under the new proposal, EU member states would not be allowed to use justifications linked to the assessment of risks to health or the environment, which have already been comprehensively addressed in the Commission's authorization decision, based on studies conducted by the European Food SafetyAuthority (EFSA), and by the EU procedures already available. The new proposed rules would mean, therefore, that the requirement that the measures applied by Members be based on scientific evidence in accordance with the SPSand TBT Agreements would not be met.
3.7.He noted that the EU was the main destination market for Paraguay's agricultural exports, receiving more that 32% of the Paraguayan soya exported worldwide. The entry into force of this EU proposal would therefore unjustifiably restrict trade, as there was no technical or scientific basis to prohibit the use of such soya. It would also weaken the provisions established by EU's own food safety authority and, at the same time, undermine legal predictability in trade. The delegation of Paraguay requested the EU to reconsider the amendment of the existing Regulation and suggested that a similar notification be made to the SPS Committee.
3.8.The representative of the United Statessaid that her delegation was still not convinced by the EU's rationale for notifying this measure to the TBT Committee. For the US, given that the proposed regulation amended an SPS measure (Regulation (EC) No1829/2003), it should have been notified to the SPSCommittee pursuant to Article 7 of the SPS Agreement. The US therefore asked the EU to make such notification to that Committee. In this respect, she recalled that the preamble to the amended Regulation specifically stated that its objective was to protect human and animal health, and that this measure was the subject of a WTO dispute regarding its consistency with the SPS Agreement.
3.9.She further observed that this proposed measure would amend the original SPS regulation so as to allow EU member states to implement bans on nonscientific grounds precisely because both the EU and its member states have repeatedly failed to justify such actions with sciencebased risk assessments. In this respect, she recalled that the 2006 WTO Panel Report in EC—Approval and Marketing of Biotech Products found nine EU member state bans to be in violation of Articles 5.1 and 2.2 as well as Article 5.7 of the SPS Agreement. It was therefore clear to her delegation that allowing EU member states to take a "case by case approach" to justifying bans and restrictions was not sufficient to circumvent the grounding in scientific principles and adequate risk assessments required by the SPS Agreement. She also noted that several members of the European Parliament have stated that this proposal appeared to raise serious concerns under WTO rules.
3.10.The representative of Canadaquestioned whether allowing EUmemberstates to ban the use of GM events that have been deemed safe by the European Food SafetyAuthority (EFSA) for consumers, livestock and the environment by a vigorous risk assessment, and approved by the European Commission, was compatible with the EU's international trade obligations, especially those under the SPS and TBT Agreements. Furthermore, the proposal appeared to pose a challenge to the concept of the EU single market and could potentially result in a patchwork of conflicting regulations across the EU. This measure, if implemented by one or more EU memberstates, would have the potential to cause serious trade disruptions for the EU's international trading partners and would introduce further uncertainty with respect to exports of GM crops to the EU. Furthermore, the use of terms and definitions, such as "use", lacked clarity and would result in further uncertainty for exporters.
3.11.The representatives of Brazil and Chile said that their respective delegations shared the concerns raised by other Members and requested the EU to also notify the proposed measure to the SPS Committee.
3.12.The representative of the European Union explained that the proposed measure would amend the EU legislation on GM food and feed so as to provide a legal basis for EU member states, if they so wished, to take a decision on the use of these products on their territory, subject to certain conditions. This proposal was not a renationalisation of the decision to authorise GMOs. GM food and feed would still remain to be assessed by EFSA in accordance with harmonised sciencebased criteria, and they would also continue to be authorised at EU level, following an EU decision of authorisation. As such, the proposal would not introduce any restriction or ban. It would only provide the possibility for EU member states, if they so wished, to opt out from the EU decision of authorisation based on overriding reasons of public interest distinct from the assessment of risks to health or the environment. She explained that strict substantial conditions were provided for in the proposal to ensure compatibility with EU law and international obligations, i.e., measures adopted by EU member states shall be based on compelling grounds, could not be discriminatory and needed to be proportionate. The mobility of GM food and feed was thus preserved under the proposal as EU member states could not restrict or ban their free circulation and import but only their use. Further, EU member states would not be allowed to restrict or ban the use of food and feed in case GMOs were present at trace level, or restrict or ban the use of products fed with GMOs.
3.13.She also explained the reason behind the EU's determination that neither the proposal, nor the national measures that could be taken on the basis of the proposal, were SPS measures as defined in AnnexA of the SPS agreement. They were not such measures, she explained, because they did not relate to the protection of the life and health of human and animals. In this respect, she noted that the reason why the proposal did not allow EU member States to use compelling grounds which related to the assessment of risks to health and to the environment, was precisely not to interfere with the EU risk assessment. However, for transparency reasons, the EU drew Committee Members' attention both to the fact that this proposal existed and to the fact that it has been notified under the TBT Agreement. She indicated that the final date to submit comments was 90 days, counted from 20 May 2015.
3.2.2.2Russian Federation – Measure affecting import of Ukrainian food salt
3.14.The representative of Ukraine voiced her delegation's concern regarding a ban of the Russian Federation on imports of food salt produced by Ukrainian State Enterprise Artyomsol. She said that the ban was imposed on 26 January 2015 by Russia's Federal Service on Customers' Rights Protection and Human Well-being Surveillance (Rospotrebnadzor) under the pretext of violation of legislation in the sphere of sanitary and epidemiological safety. The announced ground for prohibition was an alleged incompliance with the requirements for organoleptic indicators. She said that this measure was introduced suddenly and in a nontransparent manner and that, except for a short notice on the website of Rospotrebnadzor, there was no other information officially provided to Ukrainian Authorities. Russia did not provide any official results of examinations or tests, revealing any problem of inconsistency of the Ukrainian products.
3.15.She also noted that the Ukrainian producer in question effectively applied a management system for quality and safety that was in accordance with the requirements under ISO standard 9001:2008 and the quality of the product has been certified by both Ukrainian and Russian authorised bodies. The food salt of the mentioned Ukrainian producer has been exported to Russia for many years. During recent years, export of the salt products to Russia reached 55% of the company's production, more than half of which was food salt. Ukraine believed that the Russian measure was thus not justified and was applied in a nontransparent and unpredictable manner, with a view of creating unnecessary obstacles to trade. As such, this measure was inconsistent with provisions of the Articles 2.1, 2.2 and 5.1 of the TBT Agreement. Ukraine asked Russia to immediately lift this trade ban and bring the measure in line with the TBT Agreement as well as the commitments Russia has undertaken under its WTO accession.
3.16.The representative of the Russian Federation said that the temporary suspension of imports of food salt produced by Ukrainian enterprise Artyomsol was introduced due to the violation of the requirements of consumer protection technical regulations of the Eurasian Economic Union. In 2014, the Russian competent authority – Rospotrebnadzor - detected incompliances in food salt produced by Artyomsol. The products labels contained false information and the products themselves were not in compliance with the corresponding requirements for purity and iodine content. The label of salt indicated that it was iodized salt with 0.04 mg/g of iodine content according to the technical regulation of the Customs Union "on the labelling of food products". However, laboratory tests had indicated a lower amount of iodine in the salt produced by this Ukrainian producer. Due to this fact, the surveillance at the State Boarder check-points and in retail network was enforced. As of the end of 2014 and early in 2015, there were largescale detections of such products in the internal market that appeared to be deceptive practice in trade. The results of the tests confirmed incompliance with the existing requirements. Due to such incompliance, on 26 January 2015 Russia introduced a temporary import suspension of the mentioned products into its territory. The measures were imposed with the aim of protecting Russian consumers' right for reliable information on the products, and to prevent deceptive practices in trade, and to maintain, at the appropriate level of protection, the safety and life and health of population in full compliance with Article 2.2 of the TBT Agreement. She stressed that the suspension of imports was a temporary measure covering only one Ukrainian enterprise. It was not therefore a fullfledged import ban of all Ukrainian food salt products. Nevertheless, since the implementation of measure, Ukrainian competent authorities had not taken any steps to establish contacts with its Russian counterparts to resolve this issue. In order to resume the supplies of the products from this Ukraine enterprise to Russia, Ukraine should take steps to start such necessary communication at the bilateral level.
3.2.2.3China - Registration Fees for Drugs and Medical Device Products
3.17.The representative of Canada expressed his delegation's concern that this measure was published on, and was inforce since, 27 May 2015, without being first notified to the WTO. Members did not have therefore any "reasonable interval" between publication and entry into force, as required by Article 5.9 of TBT Agreement. Also of concern to Canada was the fact that China was not providing domestic registration fees for Class II medical devices. And also the fact that China was not providing for national treatment to Class III medical device manufacturers by charging imported medical devices a first registration fee that was more than double the domestic registration fee. Based on the document released, Canada also believed that China failed to provide national treatment to drug manufacturers, with imported drug registration fees being, in most cases, double what domestic drug manufacturers were charged. As a result, China was neglecting its responsibilities under Article III:2 of the GATT 1994 as well as Article 2.1 of the TBTAgreement by failing to provide the same treatment to imported drugs and medical device products as their domesticallymade equivalents. Specifically, China was charging new, imported drugs a firsttime registration fee of approximately 376,000RMB for the clinical trial, and 593,900RMB for the production listing, compared to the 192,000RMB and 432,000RMB charged to domestic drug producers, respectively. For registering generic drugs with the CFDA, China charged approximately 367,600RMB for imported product listings that did not require a clinical trial, compared to approximately 184,000RMB for domestic equivalents. For generic drugs that required a clinical trial, China charged 502,000RMB for imported drugs, compared to the 318,000RMB fee for domestic drug producers. In terms of medical devices, the first registration fee for Class III imported medical device products was approximately 308,800RMB, whereas domestically made medical device products were only charged approximately 154,000RMB. Canada asked China to explain why it was using two separate fee structures for domestic and imported drugs and medical devices?