RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/51 
1 October 2010 
 (10-5023) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 23-24 JUNE 2010 
 
Chairperson:  Mr. Amit Yadav (India)
 
 
Note by the Secretariat1 
 
 
I. ADOPTION OF THE AGENDA.............................................................................................2  
II. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2..................................................................2  
B. SPECIFIC TRADE CONCERNS .........................................................................................................2  
C. EXCHANGE OF EXPERIENCES .....................................................................................................62  
III. TECHNICAL COOPERATION ACTIVITIES...................................................................65  
IV. UPDATING BY OBSERVERS .............................................................................................66  
A. INFORMATION FROM OBSERVERS .............................................................................................66  
B. APPLICATIONS FOR OBSERVER STATUS IN THE TBT  COMMITTEE ...........................................66  
V. DATE OF THE NEXT MEETING .......................................................................................67  
ANNEX 1  SUMMARY REPORT OF THE SIXTH SPECIAL MEETING ON  
PROCEDURES FOR INFO RMATION EXCHANGE.......................................................68  
A. SESSION 1 – GOOD PRACTICES IN NOTIFICATION .....................................................................68  
B. SESSION 2 – ELECTRONIC DATABASES .....................................................................................72  
C. SESSION 3 – OPERATION OF ENQUIRY POINTS ..........................................................................78  
D. SESSION 4 – TRANSPARENCY IN STANDARD SETTING ...............................................................82  
ANNEX 2 REPORT BY THE CHAIRMAN ON THE SIXTH SPECIAL MEETING ON 
PROCEDURES FOR INFORMATION EXCHANGE UNDER THE TBT AGREEMENT ...................................................................................................................... ..89
 
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. G/TBT/M/51    
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  I. ADOPTION OF THE AGENDA   
1. The Committee adopted the agenda contained in WTO/AIR/3565. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT   
A. 
STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
2. The Chairman recalled that the latest list of  statements submitted under Article 15.2 of the 
TBT Agreement is contained in G/TBT/GEN/1/Rev.9,  issued on 5 February 2010.  He noted that 
since the previous meeting of the Committee, Pa raguay had submitted a revision to its statement 
under Article 15.2 (G/TBT/2/Add.91/Rev.2).  In to tal, since 1995, 119 Members have submitted at 
least one Statement on implementation under Article 15.2.   The latest list of enquiry point contacts is 
contained in document G/TBT/ENQ/37, issued on 15 June 2010. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) European Union – Directive 2004/24/EC on Tradi tional Herbal Medicinal Products  
3. The representative of China  raised concerns about the EU Directive 2004/24/EC on 
traditional herbal medicinal products, which amended Directive 2001/83/EC.  It was her delegation's 
understanding that while the 2001 Directive regulated  the manufacture, marketing and distribution of 
all medicinal products for human use, the 2004 Directive amended the former by introducing a 
simplified registration procedure for traditional herb al medicine products.  While China supported the 
objective of protecting human health and promo ting the use of safe herbal medicinal products, 
concerns remained that the EU m easure was unnecessarily trade restric tive.  China also noted that the 
European Union failed to notify the two measures to  the WTO and encouraged the EU delegation to 
act promptly in this regard, so as to provide the opportunity for WTO Members to comment on the 
text of the regulations.   
4. The EU delegation was also requested to ex tend the transitional period for simplified 
registration to March 2019 (instead of March 2011), in order to provide  industries with adequate time 
to consider the requirements and make the registrati on accordingly.  It was stressed that, to date, only 
one Chinese enterprise had registered its products th rough the new procedure – this illustrated the 
complexity of the new requirements.  Furthermore,  the representative of Ch ina invited the European 
Union to provide evidence of the scientific basis for not permitting animal and mineral ingredients in 
traditional herbal medicinal products.  It was her delegation's view that herbal medicinal products 
containing animal and mineral ingredients had been sa fely used in China and other parts of the world 
for thousands of years, and they still played an im portant role in modern health care.  Finally, the 
European Union was encouraged to recognize the Good Manufacturing Practice for medicinal 
products of China as equivalent, and to provide an update on the current status of implementation of 
the 2004 Directive and a timetable for amending the 2004 Directive. 
5. The representative of India  noted his delegation's concern with the EU Directive on traditional 
herbal medicinal products.  It was India's unde rstanding that the 2001 Directive required that 
applications for authorization to place a medicine on the EU market had to be accompanied by a 
dossier containing the results of physiochemical and biological tests, as well as pharmacological, toxicological and clinical trials carried out on the product.  These requirements appeared to be 
cumbersome, particularly for traditional herbal  medicinal products, and could constitute an 
unnecessary barrier to trade.  India further noted  that the European Union had recognized the 
complexity of such system and decided to amend the 2001 Directive accordingly, in order to simplify  G/TBT/M/51  
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  the registration procedure for traditional herbal me dicinal products.  However, neither the 2001 nor 
the 2004 Directive had been notified to the TBT Committee.   
6. The representative of India was particularly concerned about the 15 year requirement set out 
in Article 16 of the 2004 Directive:  to be marketed  in the European Union, there had to be sufficient 
bibliographical or expert evidence that a herbal  medicinal products had been in use throughout a 
period of at least 30 years – including at least 15 years within the EU market.  It was India's view that 
these requirement could result in a de facto  ban on imports of herbal me dicinal products from a large 
number of suppliers of traditional herbal medi cinal products, particular ly Small and Medium 
Enterprises (SMEs).  When the 15 year requireme nt was not met – but the product was otherwise 
eligible for simplified registration – the authoriza tion had to be referred to the Committee for Herbal 
Medicinal Products.  However, the guidelines a nd parameters on how the Committee would assess 
this product had not been disclosed.  What was the scientific basis and rational justification for the 15 
year prior use requirement and was there the possi bility of derogating from it?  Had the European 
Union considered other alternative methods or  procedures for assessing the safety, quality and 
efficacy of traditional medicinal products?  What  was the coverage of the 2004 Directive and the 
discipline applicable to the marketing of herb al products not covered by the above-mentioned 
regulation?   
7. The representative of Ecuador  shared the concerns express ed by previous speakers and 
stressed that the EU measure could have  a significant impact on Ecuador's exports. 
8. The representative of the European Union  noted that her delegation had met bilaterally with 
China and India on this issue and confirmed that, wi th regard to traditional herbal medicinal products, 
the 2004 Directive amended the standard authorizatio n procedure which was in place for all medicinal 
products.  She further explained that the 2004 Dir ective provided a simplified registration procedure 
for traditional herbal medicines, for example by ex empting the manufacturer from providing a number 
of tests and clinical trials which were otherwi se required under the normal authorization procedure.  
Article 16 of the 2004 Directive set the criteria that the products had to fulfil in or der to be eligible for 
the simplified procedure:  (a) ther e had to be sufficient bibliographical or expert evidence that the 
product had been in use throughout a period of at least 30 years – including at least 15 years on the 
EU market; and (b) the manufacturer had to provi de evidence on the product safety and efficacy.  
However, when the product met only the second criterion,  the authorization could still be referred to a 
Committee for Herbal Medicinal Products.  This Co mmittee would verify if the other requirements 
were met and would establish a "community herbal  monograph"; in that case, the manufacturer only 
needed to prove the qualit y characteristics of its product.  It was the EU representative's view that the 
15 year requirement did not constitute any obstacl es for manufacturers to benefit from the simplified 
procedure.  However, she informed Members of  the Committee that the European Commission had 
carried out an internal reflection process on the re gistration of traditional herbal medicines, which 
concluded with the drafting of a report.  This repor t highlighted that the Commission was prepared to 
consider extending the simplified registration proced ure to products containing substances other than 
herbal substances, and that the 15 year cr iteria could be reassessed.  These changes would 
nevertheless require legislative action.  
9. With regard to the timeline of the transiti onal period, the representative of the European 
Union explained that the 2004 Directive gave manuf acturers seven years to submit an authorization 
request for the marketing of products to the releva nt authorities.  As of March 2011, no authorized 
herbal medicines could be sold on the EU mark et as medicinal products – they could, however, 
continue to be sold as standard products.  The Eu ropean Union regretted that the two directives had 
not been notified to the WTO.  However, interested  parties had had exchanges with EU authorities for 
several years and the EU delegation remained ava ilable to further discuss this issue bilaterally. G/TBT/M/51    
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  (ii) China – Textiles (G/TBT/N/CHN/20/Rev.1) 
10. The representative of the European Union
 expressed concerns regarding China's new General 
Safety Technical Code for Textile Products.  Sh e noted that the Chinese draft measure on textile 
products set mandatory limit PH values, and values fo r colour fastness.  It was her delegation's view 
that these requirements did not impact on consumer's health or safety and were therefore more trade 
restrictive than necessary.  The notified draft also  provided that textiles c ould not have a peculiar 
odour.  It was the European Union's view that this requirement could only be verified by a subjective assessment and was not an appropriate means of clas sifying textile products.  The EU delegate further 
noted that the Chinese draft regulation prohibited the presence of the aromatic Amines 2.4 and 2.6 Xylidine in textiles and set a maximum level of 20 mg/kg for their use of acrylamine dyes.  
Considering that the EU's REACH Regulation di d not prohibit the above-mentioned aromatic 
substances and set a higher maximum level for th e use of acrylamine dyes, the European Union 
invited the Chinese delegation to provide the scien tific evidence on which China's decision had been 
based.  Finally, the EU representative urged China to c onsider the relevant ISO standards, particularly 
with regard to test methods, which had the pote ntial to create unnecessary obstacles to trade when 
deviating from relevant internationa l standards without justification. 
11. The representative of China
 noted that the EU written comments had been received after the 
period for comments on the draft measure had expire d.  However, they were being processed and a 
reply would be provided to the European Union in due time. 
(iii) China – Textiles and Apparel (G/TBT/N/CHN/427)  
12. The representative of the European Union  raised a concern regarding China's new draft 
regulation on textiles and apparel, notified to the Committee under G/TBT/N/CHN/427.  She noted 
that her delegation had commented on this notifica tion in July 2008 and had asked China to provide 
further clarification on its measure.  In particul ar, it was the EU's delegation view that certain 
information to be displayed on textiles – such as the product name, the effective product standards, 
safety categories and the use and storage precautions – did not appear to be relevant to the objective 
of informing consumers.  The representative of the European Union also stressed that China had first 
informed her delegation that the draft measur e was still under consideration and the mandatory 
labelling requirements could be modified.  It had also been mentioned that the modified draft 
regulation would have been notified to the WTO.  However, in November 2009, the EU delegation 
had been informed that the notified text was about to be published and that no new notification was 
envisaged.  Finally, in May 2010, the Chinese Enquiry  Point had confirmed that the draft measure was 
still under discussion.  In view of this contradictin g information, the EU representative requested an 
update on the status of these issues, including how  the comments of her delegation had been taken 
into account. 
13. The representative of Switzerland  shared the concerns expressed by the European Union.  She 
was particularly concerned about the country of origin requirement for imported products.  Could 
China explain the compliance of this requirement with  the principle of national treatment contained in 
Article 2.1 of the TBT Agreement?  Could China sp ecify how the country of origin requirement was 
defined and what was the legitimate objective that th is requirement intended to pursue?  Could China 
clarify whether the Chinese standards GB/T 8685 Textile-Care Labelling Code was based on the 
relevant ISO standard?  
14. The representative of China  thanked the delegations for thei r comments and recalled that 60 
days had been provided for comments on this notifi cation.  She also informed the Committee that the 
period for comments had been extended for another month, as requested by the European Union.  
However, no comments had been received from the Eur opean Union within that timeframe.  In this 
regard, the Chinese delegation encouraged the Europ ean Union to provide comments within the time  G/TBT/M/51  
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  period provided so as to give time for comments to be  taken into consideration. With regard to the 
questions from Switzerland, the representative of China said that the labelling requirements would 
apply equally to domestic products, and therefore the notified measure complied with Article 2.1 of 
the TBT Agreement.   Finally, the representative of  China informed WTO Members that the national 
standard had not yet been published and comments would be taken into account.  
(iv) Viet Nam – Alcoholic Beverages (G/TBT/N/VNM/10) 
15. The representative of Chile  raised concerns about Viet Nam's new proposed National 
Technical Regulation on Food Safety for Alcoholic Be verages, and informed the TBT Committee that 
her delegation had provided written comments to Viet  Nam on the draft regulation.  It was Chile's 
belief that the notified draft regulation would limit certain substances at 100 grams.  The 
representative of Chile expressed the view that 100 grams was a very low limit and particularly 
difficult to achieve for wines, effectively limiting th eir market access.  She noted the importance of 
having more clarity with respect to the controlle d substances and generic substances in the products 
that would need to be limited.  Finally, she sugg ested that the legislation be based on international 
standards.  
16. The representative of the European Union  also expressed concerns over Viet Nam's draft 
regulation, noting that they had recently received a reply from Viet Nam on their written comments.  
The European Union was grateful for the open and constructive position taken by the Viet Nam authorities and was analyzing the reply to ascertain whether the European Union's comments had been 
addressed.  She asked Vietnam to confirm that the maximum limit for aldehydes in distilled spirits 
and mixed spirits would be abolishe d as indicated in their written reply.  She requested confirmation 
from Viet Nam that the maximum cyanide limit and microorganisms requirement would be eliminated 
and that the definitions of wine and sparkling wines, as well as the limits on methanol and sulphur 
dioxide in wines, would be revised to bring them  in line with international practices.  She also 
requested clarification from Viet Nam on the admi nistrative requirements specified in the draft 
regulation, such as compliance announcement, comp liance certification, compliance certification 
stamps and compliance evaluation methods, and on  guidelines on implementation.  Finally, she 
requested an update from Viet Nam on when the revi sed draft regulation would be made available. 
17. The representative of Mexico
 thanked Viet Nam for replying to their initial comments on the 
draft regulation.  He requested confirmation that the maximum limit of alde hyde would be eliminated 
from the regulation and asked when the final ve rsion of the regulation would be published.  
18. The representative of Australia  thanked Viet Nam for replying to their initial comments on 
the draft regulation and expressed appreciation over Viet Nam's willingness to bring the regulation in 
line with international standards.  Australia join ed the European Union and Mexico in requesting 
clarification on the proposed timetable for redrafting the proposed regulation.  
19. The United States  reiterated the concerns they had communicated to Viet Nam in writing 
regarding the draft regulation. It was the US view  that Viet Nam's technical regulation defined a 
maximum level for aldehydes in distilled spirits of 5mg per litre of alcohol.  The United States noted 
that they supported Viet Nam's objective to ensure the identity and quality of alcoholic beverages sold 
in Viet Nam, but observed that for nearly all majo r spirit markets, the identity for distilled spirits was 
based on the raw materials and production process used , rather than on the chemical composition.  
The representative of the United States stated that he  was unaware of any health, safety, quality, or 
other concern with aldehyde that could warra nt mandating a maximum level.  He requested 
clarification on how often importers would be required to have the product certified; how often testing 
would have to be conducted; how certification would need to be obtained; how certificate grades 
differed; and which products required the compliance certification stamp.  G/TBT/M/51    
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20. The representative of Viet Nam
 noted that delegations supported the legitimate objective to 
protect human health and safety through this tec hnical regulation.  He informed the TBT Committee 
that the deadline for making comments on the draft regulation would be extended from 23 May 2010 to 17 July 2010 and ensured delegations that comme nts and concerns raised would be taken into 
account; he requested that comments be submitted in writing to the Viet Nam TBT Enquiry Point.   
(v) United States – Conditions and Criteria for Recognition of Accreditation Bodies & 
Laboratories for the Energy Star Program  
21. The representative of Korea
 raised concerns regarding US draft requirements for accreditation 
bodies and testing laboratories in the Energy Star Prog ram.  It was Korea's belief that the additional 
requirement imposed by the US Environmenta l Protection Agency (EPA) was duplicative and 
unnecessary.  The representative of Korea urged the Un ited States to reconsider by allowing for the 
designation of accreditation bodies for Energy Star without an additional process involving ILAC/MRA accreditation bodies.  He also requested more detailed information on the peer evaluation 
procedures and training programmes.  Korea was of the opinion that the requirement to report to the 
EPA on the result of the ILAC/MRA peer evaluati on were against the confidentiality rule of ISO 
17011. 
22. Korea was also of the view that the draft requi rements were against the spirit of ILAC/MRA.  
The representative of Korea expressed concern that the draft laboratory requi rements would allow the 
EPA to operate inter-laboratory comparison testing,  a provision which, according to Korea, would be 
unnecessary given that ILAC/MRA Member accredita tion bodies already operated internationally 
recognized proficiency testing.  Finally, he urged the United States to notify this measure to the TBT 
Committee and to allow sufficient preparation time for manufacturers and their accreditation bodies and testing laboratories before implementing the new measure.  
23. The representative of the United States
 noted that bilateral discussions had taken place with 
Korea the week prior to the TBT Committee Meeting,  after which he felt he better understood Korea's 
concerns and would communicate them to regulators in  the United States.  He explained that Energy 
Star is a voluntary government backed programme  dedicated to helping protect the environment by 
promoting superior energy efficiency products.  In or der to earn the Energy Star, products had to meet 
strict energy performance criteria set by the US EPA and the Department of Energy.  He informed the 
Committee that Energy Star currently covered a bout 3 Billion units, sold across more than 40,000 
models, in more than 60 product categories. Additi onally, more than 75 per cent of US consumers 
were aware of the programme and 80 per cent indi cated that the logo influenced their purchasing 
decisions and likeliness to recommend products to ot hers.  He was of the view that an 18 year 
partnership between the EPA and st akeholders had made the Energy Star brand valuable, with most 
producers seeking to satisfy its criteria.  He suggested that the success of the programme demonstrated that WTO Members could satisfactorily  achieve legitimate regulatory objectives using a 
voluntary approach – and not only through mandatory ones. 
24. The representative of the United States next explained the importance of conformity 
assessment in maintaining the value of the Energy Star brand. He suggested that, given the evolution 
of the programme, supplier's declaration of conform ity (SDoC) that a product meets the Energy Star 
criteria had proven to be insufficient. In a recent review of the programme by the US General Accounting Office, vulnerabilities and potential for fr aud in the current qualification process had been 
identified. Additionally, over the years, the EPA had found numerous products on the market 
displaying the Energy Star label that did not actually  meet the criteria. He noted that when asked to 
stop using the Energy Star label, the companies in  question voluntarily obliged.  He informed the 
Committee that additional information, including the General Accounting Office report, could be 
found on the Energy Star website. He declared that  the EPA's proposed requirements for accreditation  G/TBT/M/51  
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  bodies and testing laboratories in the Energy Star program were meant to address these and other 
issues. 
25. The representative of the United States confirmed that under the proposed modifications,  
Energy Star would remain a voluntary programme a nd producers would be able to test outside the 
United States, whether in their own facilities or in third party laboratories.  Furthermore, goods could 
continue to be shipped to the United States regardless  of whether they met the Energy Star criteria.  
He clarified that the proposed modifications would simply strengthen the conformity assessment procedures to better ensure that products bearing the Energy Star label in fact met the Energy Star 
criteria.  It was the belief of the United States th at maintaining a voluntary approach and basing new 
conformity assessment procedures on international st andards was a better way of ensuring Energy 
Star compliance than potentially stricter alternatives.  
26. The representative of the United States noted  that the proposed procedures were based on 
relevant international standards, guides and recommendations including ISO 17011 and 17025 and 
Guide 65, and international systems of conform ity assessment such as the ILAC/MRA; thus, the 
United States was not obliged to notify this me asure.  He informed th e Committee however that 
discussions on the proposal had taken place sinc e 2009 between US regulators and foreign and 
domestic stakeholders. In December 2009, an enhan ced programme plan for Energy Star, identifying 
increased testing as a possibility in connection with  the Energy Star label, was shared by US 
regulators with thousands of stakeholders.  He noted that comments had been solicited and EPA's 
responses could be found on the Energy Star website .  In March 2010, anot her stakeholder process 
had been launched by EPA to devel op detailed enhanced testing verifi cation for Energy Star products.  
The representative of the United States informed th e Committee that comments were initially solicited 
by 30
 April 2010, however, WTO Members were encour aged to submit additional comments to the 
EPA until the end of June 2010. 
(vi) Colombia – Shelf life Requi rements for Milk Powder 
27. The representative of the European Union  expressed concerns with respect to a Colombian 
Decree, dated 13 May 2010, which re quired imported milk powder to have a minimum shelf-life of 12 
months, a six month increase over the previous requirement.  She noted that this Decree had already entered into force without being notified to th e TBT Committee but acknowledged that Colombia had 
recently notified the implementation rules of  the Decree to the SPS Committee, allowing for 
comments until 10 September 2010.  The European Un ion requested clarification from Colombia on a 
number of issues including: (i) whether Colombia  intended to notify the TBT Committee of the 
regulation, (ii) whether implementation of the Decr ee would be postponed during the comment period 
granted in the SPS Committee, (iii) which legitima te objective was being pursued, and (iv) whether 
the Decree applied to domestically produced milk powder.  
28. The representative of Colombia
 acknowledged that they had received and forwarded the 
European Union's comments to the relevant authoriti es within the Ministry of Social Protection.  He 
informed the Committee that upon receiving a res ponse from the relevant authorities, Colombia 
would respond to the concerns raised. In the me antime, he expressed his delegation’s willingness to 
continue bilateral discussions with the European Union. 
(vii) China – Regulations of the PRC on Certifica tion and Accreditation (promulgated by Decree 
No. 390 of the State Council of the PRC on September 3, 2003) 
29. The representative of the United States  expressed concerns over China's regulations on 
certification and accreditation. It was the view of the United States that China was limiting US 
suppliers' ability to use competent conformity ass essment bodies, including testing laboratories and 
product certifiers outside of China's territory, to demonstrate their products compliance with Chinese G/TBT/M/51    
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  technical regulations.  The representative of the Un ited States explained that in order to export to 
China, US and other foreign exporters had been  required to use conformity assessment services 
provided by bodies designated by the Chinese Gove rnment, in the Chinese market.  This barred 
recognition of foreign conformity assessment bodies, including ILAC or IAF accredited bodies.  This 
regulation had put foreign companies at a disadvantage vis-à-vis  their Chinese competitors for two 
reasons.  First, US exporters ha d to have their products tested and certified in China, an often 
duplicative process which imposed additional costs and burdens on US exporte rs.  Second, Chinese 
producers often had more direct access and closer ties to Chinese testing and certification bodies.  In 
addition, he explained that the regulations had resulted in a loss of opportunities for US conformity assessment bodies to provide conformity assessment services for the Chinese market.  
30. The representative of the United States explai ned that the CCC mark, China's primary safety 
and quality certification scheme, fell under the regul ations on certification and accreditation.  He 
informed the Committee that over 20 per cent of US  exports to China had to obtain the CCC mark 
prior to market entry and that there was only one designated certification body in China authorized to 
issue the mark and one accredited testing laborator y to perform testing and inspection for any given 
product category under the CCC system.  It was the understanding of the United States that, despite 
China's accession commitment that qualifying mi nority foreign owned and majority foreign owned 
joint venture conformity assessment bodies would be eligible for accreditation and would be accorded 
national treatment, only six foreign invested conf ormity assessment bodies had been accredited.  
Furthermore, it appeared to the United States that  these six foreign invested conformity assessment 
bodies had not been permitted to play a role in  accrediting products under the CCC system.  The 
representative of the United States noted that one  US based conformity assessment body had entered 
into an MoU with China, allowing that bod y to conduct one aspect of the CCC certification 
requirements.  However, it was the understanding of his delegation that China had not been willing to 
grant similar rights to other US based conformity assessment bodies on the grounds that they were only allowing one MoU per country.  He noted that  China had not provided a rationale for this. He 
also noted that China had rejected suggestions  that it recognize bodies accredited by ILAC/MRA or 
IAF MLA signatories or that it develop other pro cedures to recognize foreign conformity assessment 
bodies, insisting instead that it would accept conformity assessment bodies domiciled abroad only if their governments negotiated MRAs with China.  
31. The representative of the United States recalle d that the TBT Agreement encouraged WTO 
Members to permit foreign laboratories to participate in their conformity assessment procedures on 
terms no less favourable than those accorded to do mestic or other foreign conformity assessment 
bodies and required Members to accept wherever possibl e test results, certification and other forms of 
assurance performed in other Members’ territories provi ded they were satisfied that they offered an 
assurance of conformity equivalent to their own.  Furthermore, Members had to adopt, wherever 
practicable, international systems of conformity assessment. He suggested that China take positive 
steps to liberalize its approach to recognizing fo reign conformity assessment bodies and expressed his 
delegation's willingness to engage further in dialogue with China in exploring alternative approaches 
to reduce costly and duplicative testing and certif ication requirements for US and other foreign 
companies doing business in China. He asked whethe r China was giving consideration to the ILAC 
and IAF accreditation systems under the CCC mark scheme.  
32. The representative of China
 explained that the objectives of the regulations were in line with 
the legitimate objectives of the TBT Agreement, i.e. safeguarding national security, preventing 
deceptive practices and protecting human health or  safety, animal plant life or health, or the 
environment.  It was the view of China that the regulations complied with the non-discrimination 
principles of the TBT Agreement.  The representa tive of China explained that his country had 
engaged in mutual recognition bila terally and multilaterally, including China's membership in IECEE 
and ILAC/MRA.  He explained that China was accepting CB reports issued by the CB testing 
laboratories of other countries, within the scope  of the IECEE scheme.  Bilaterally, China had  G/TBT/M/51  
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  concluded a total of 40 bilate ral cooperative documents with 23 countries/areas, identifying 
ILAC/MRA as a key technical base for mutual r ecognition between China and other countries. He 
noted that there were 168 conformity assessment bodies recognized by China, 35 of which were 
foreign funded bodies, the list of which could be  found at www.cnca.gov.cn. He explained that in 
order to shorten the certification process and reduce burdens for enterprises seeking CCC 
certification, China had taken a number of measures,  including: (i) using online application forms and 
online acceptance of compulsory product certification; (ii) recognition by the CCC scheme of CB test reports issued under the IECEE scheme and co mmissioning follow-up inspection of overseas 
manufacturers after certification to local certificati on bodies; (iii) reducing the certification fee by an 
average of 20 per cent; and iv) implementing classified management for key components. 
(viii) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels 
33. The representative of the United States
 raised concerns over Korea's standard for thin-film 
solar panels. It was the understanding of the Unite d States that since 2008, Korea had required solar 
panels to be certified by the Korean Management Ener gy Cooperation in order to be sold in Korea. 
Additionally, in 2007, Korea had issued a mandatory  Korean standard for thin-film solar panels (KS 
61646).  The representative of the United States pointed  out that while the Korean standard appeared 
to be based on the international standard IEC 61646,  which also dealt with thin-film solar panels, the 
Korean standard only applied to one type of so lar panel, amorphous silicon  type thin-film solar 
panels, excluding other types of thin-film solar pane ls.  He explained that as a result, other leading 
solar panels, including those from cadmium telluri de and copper indium se lenide, as well as gallium 
arsenide which was an emerging commercially proven  technology, could not be tested or certified 
under the Korean standard and thus were not able gain the necessary certification to be placed on the 
Korean market.  According to US industry, Kor ea had been the only coun try in the world that 
specifically restricted application of the IEC standa rd to only one type of thin-film solar panels.  
34. The representative of the United States noted  that Korean producers manufactured the 
amorphous silicon type thin-film sola r panels, the only type of thin-fi lm solar panel that was allowed 
to be sold in Korea.  Conversely, foreign producers manufactured the types of panels not covered by 
the Korean standard and were not able to gain  the certification necessary to be sold in Korea. 
Consequently US companies had left the Korean market.  The United States was not aware of any 
scientific or technical evidence indicating that th ere had been risks from using the thin-film solar 
panels not covered by the Korean version of the IEC standard.  The representative of the United States 
noted that while the measure had hurt US compani es, it also had the effect of keeping the most 
innovative solar panel products out of Korea and limiting Korean producer s from moving into the 
next generation of technologies.  It was the view of  the United States that it would not only facilitate 
trade to allow other types of thin-film solar panels to be certified to the Korean standard but it would 
also allow Korea to benefit from the best availa ble technologies in this important area of energy 
conservation.  
35. The representative of Korea  clarified that his country did not maintain their standards on a 
mandatory basis. All standards had been voluntary in  their use and that even without certification, 
products could be sold in the Korean market.  He confirmed that the Korean standard for thin-film 
solar panels had been largely based on IEC 61646,  with the exception of test requirements for 
cadmium telluride based solar panels and copper in dium gallium selenide solar panels which had not 
been taken into account.  He explained that these tw o types of thin-film panels had not been included 
in the Korean standard because  they used toxic substances like cadmium in their manufacturing 
processes or in the product itself.  He informed the Committee that the Korean Energy Management 
Cooperation (KEMCO) had recently launched a feasi bility study for the environmental and safety 
impacts of these substances in solar panels.  He e xplained that once the study was complete, in one to 
two years, the Ministry of Knowledge Economy woul d take a decision on the inclusion of the other G/TBT/M/51    
Page 10  
 
  two types of thin-film solar panels in the Korean standard.  He noted that comments from the United 
States would be passed on to KEMCO.  
(ix) China – Measures on the Environmental M anagement of New Chemical Substances 
(G/TBT/N/CHN/210 and Rev.1) 
36. The representative of Saudi Arabia
 raised concerns regarding China's proposed amendment to 
the measures on the environmental management of New Chemical Substances, which had been 
notified to the TBT Committee.  While Saudi Arab ia supported China's objective of protecting human 
health and the environment, concern was expressed with  respect to a number of issues.  With regard to 
the local testing requirement, it was Saudi Arabia 's understanding that the new regulation required 
chemical test reports to be performed in Chin a, according to Chinese st andards.  The Chinese 
delegation was invited to explain the reasons for such a requirement, including whether China would 
recognize testing conducted in inte rnational accredited laboratories.  With regard to the risk 
assessment requirements, it was the Saudi Arab ia delegation's understanding that the Chinese 
regulation required:  (i) risk assessment reports for notification;  (ii) risk monitoring as a precondition 
for a listing in the Inventory of Existing Chemical Substances;  (iii) annual reporting requirements for 
the registrant and the downstream processors;  and (iv) a prohibition on the sale or transfer of 
chemicals to those "who do not have the capacity to take risk control measures".  Again, these 
operations had to be conducted acco rding to Chinese standards.  Chin a was asked to provide further 
information on the above-mentioned requirements, in cluding the applicable risk assessment standards 
and to clarify what constituted "s uitable risk control measures". 
37. With regard to the notification requirements,  Saudi Arabia encouraged China to provide 
information on the specific notification require ments for each classification foreseen by the new 
regulation.  Regarding the Invent ory of Existing Chemical Substa nces, the delegation from Saudi 
Arabia sought confirmation that chemicals listed in the inventory would not be subject to the 
requirements set by the new regulation.  Could China al so clarify what was the status of the chemical 
substances that had been notified but not yet in cluded in the Inventory of Existing Chemical 
Substances?  Furthermore, the representative of  Saudi Arabia noted that the Chinese regulation 
contained only general language on the protection of confidential information.  Could the Chinese 
delegation provide clarification on the specific pr ovisions for the protection of confidential business 
information that China intended to adopt?  Finally,  the delegate of Saudi Arabia noted that the 
regulation was planned to enter into force on 15 October 2010 and requested the Chinese authorities 
to postpone its implementation.   
38. The representative of China  recalled that 60 days had been provided for comments on this 
notification and no comments had been received from WTO Members.  He confirmed that the notified measures had been adopted in December 2009, offi cially published in January 2010, and would enter 
into force 15 October 2010.  The representative of Chin a also noted that this was a new issue that had 
not been previously raised and his delegation had not been made aware of the concerns expressed by 
Saudi Arabia.  However, he stated that given Saudi Arabia's interest, his delegation would be 
available to discuss this bilaterally af ter the issue was reviewed in capital. 
2. Previously raised concerns 
(i) European Union – Regulation on the Regist ration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52 and Adds.1-5;  Add.3/Rev.1; G/TBT/N/EEC/295 and Add.1; G/TBT/N/EEC/297; G/TBT/N/EEC/333-6)   
39. The representative of Argentina
 reiterated his delegation's con cern with regards to REACH: 
the regulation was an unnecessary barrier to trade. B esides there was a lack of transparency by not 
providing straightforward information about how the system worked.  Small and medium sized  G/TBT/M/51  
 Page 11 
 
 
  enterprises (SMEs) exporting from Argentina had faced difficulties in coping with and understanding 
the regulation since it came into existence and fa ced disproportioned costs in complying with the 
regulation.  While he noted that the European Union had issued explanatory guides to assist in 
meeting the regulation, these guides were too extensiv e.  Moreover, the update of some explanatory 
guides would be available after the date in which expires the registration of substances produced or 
exported in quantities over 1000 tons per annum and of substances wh ich are carcinogenic, mutagenic 
or toxic (30 Nov.2010).  The explanatory guides were not sufficient and technical assistance was 
essential. The Regulation itself recognized the need to provide technical assistance and capacity 
building activities in developing countries (article  77 paragraph l of Regulation EC No. 1907/2006). 
40. With regard to the disproportionate costs SMEs  faced in complying with the provisions of 
REACH, the representative of Argentina listed the co stly registration procedures, the submission of 
evidence, the sharing of data, and conformity st atements.  These requirements put SMEs operating 
outside the EU at a disadvantage compared with businesses operating within the European Union as 
these businesses often had to open an office within th e European Union or hire a single representative 
to simplify the procedures.  He explained that th is imposed additional costs on exporters, which were 
seen as necessary to continue operating in the EU  market.  He pointed out that EU businesses and 
enterprises did not need to comply with these pr ocedures and encouraged the European Union to 
modify the measure, particularly with respect to th e complicated nature of the regulation and the costs 
involved in complying with it.  It was the view of Argentina that if this issue was not addressed, exporters would be excluded from the European chemical substances and compounds market.  The 
representative of Argentina noted that El Salvad or would be making a statement on behalf of 
GRULAC, reflecting the concerns felt throughout th e Latin American region regarding REACH.  He 
noted his delegation's support for the forthcoming GR ULAC statement.  He concluded that Argentina 
supported the aim of protecting health and the environment but was of the view that REACH 
constituted an unnecessary barrier to trade.   
41. The representative of Canada
 noted that her delegation had received a written response from 
the European Union regarding the aide memoire  from mid-May and that Canadian officials were 
currently assessing it.  She noted that the Europ ean Chemicals Agency (ECHA) had published its 
Annex V Guidance and she asked how this fast-t rack guidance update procedure was intended to 
operate, and how this would affect oils sourced from ge netically modified (GM) plants in the interim.  
It was the understanding of Canada that at the J une CARACAL meeting, ECHA had indicated that the 
Annex V Guidance would be reviewed "with a view to be amended" after 30 November 2010.  The 
representative of Canada asked what ECHA in tended to accomplish through those amendments, 
whether there would be a consulta tion process, and if so, which stak eholders would be  consulted and 
what the timeline would be. 
42. The representative of India  explained that after consultati on with Indian stakeholders, his 
delegation wanted to express its concern with the EU  REACH Directive, particularly with regard to 
the burdensome registration procedures.  Regardi ng the economic rational of the regulation, the 
representative of India asked why the technical dossi er and chemical test reports needed to be 
prepared separately by each manufacturer for each ch emical preparation substance, when the detailed 
data was already publicly available and no new chemi cal preparation substances had been produced in 
the process.  Using the example of monomers and polymers, he explained that the approach to determining the selection of polymers for regist ration on the basis of sound technical and valid 
scientific criteria was cl early acknowledged; why, therefore, ha d not the same approach been adopted 
for other substances?  He asked what the justifica tion was for registering all substances without sound 
technical and valid scientific criteria.  Given that the life cycle of a monomer would end when reacted 
into a polymer, and that information on monomers in  polymers did not enable conclusions on the risk 
of polymers produced, he asked for the rationale in requiring the registration of monomers in the first 
place. G/TBT/M/51    
Page 12  
 
  43. With regards to difficulties SMEs faced in complying with REACH, the representative of 
India asked for the EU view on the particularly high costs and the administrative burdens of the 
Substance Information Exchange Forum (SIEF) member ship that these suppliers face.  It was India's 
view that by creating such bodies, which were prim arily controlled by the EU domestic industry, and 
were beyond the control of any regulatory oversight , the EU was placing exporters at a disadvantage.  
The representative of India asked for information on the number of existing manufacturers in the EU 
territory, as well as the turnover rate for SMEs, in orde r to understand the effect of the regulations on 
SMEs in the EU's domestic industry.  India was also of the view that a number of alternatives existed 
to animal testing, noting that an EU GRC study found that approximately 50 per cent of chemicals 
under REACH could instead be tested by computer si mulation.  The OECD was also in the process of 
drafting guidelines on animal testing.  The representative of India asked whether as assessment of 
such viable alternatives had been considered by th e EU as a critical aspect of any chemical regulation 
that purported to minimize costs and incidence of animal testing.   
44. The representative of Japan
 expressed his delegation's con cern regarding the overlapping 
regulations covered under REACH a nd the Restriction of Hazardous Substances (RoHS) Directive.  It 
was the view of Japan that a number of substa nces were redundantly c overed by REACH and the 
RoHS Directive.  Specifically, those covered in th e notification according to Article 7 and in the duty 
to convey information according to Article 33 of th e REACH Regulation with regard to the candidate 
list substances, as well as in Article 4 of the RoHS  Directive as substances subject to prohibition or 
restriction.  As an example, the representative of Japan explained that if an article contained an 
identical hexavalent chromium compound or lead compound, the substance was subject to multiple 
regulations under both controls.  However, the appl ication of the threshold value differed across the 
two regulations.  In REACH, the entire article wa s the denominator in the calculation while in the 
RoHS Direction the homogeneous material in the article was the denominator.  If the draft RoHS 
Directive Amendment were to be enacted in th e future, substances could be regulated by two 
regulations with different applications.  Japan st ressed that such a situation would cause complexity 
and confusion for non-European expor ters of articles to Europe.   
45. The representative of the United States  stated that his delegation shared the EU's interest in 
protecting human health and the environment, but continued to have trade related concerns with 
REACH and its implementation.  Without restating all concerns raised at previous meetings, he 
highlighted some that were of par ticular concern to the United States.  First, he asked for an update on 
the EU's efforts to finalize the remaining guidance do cuments in time for stakeholders to be able to 
rely on this information in preparation for the firs t registration deadline.  US stakeholders felt that 
there was a lack of transparency and legal cer tainty in the implementation process which made 
compliance planning difficult and limited their opportunities to provide input.   
46. Second, the United States reiterated concerns it had previously raised on the issue of 
differences in interpretation between the Commissi on and some member States regarding the 0.1 per 
cent threshold for the notification and communicati on obligations with respect to substances on the 
candidate list.  The representative of the Unite d States asked whether the European Union could 
elaborate on the steps it would take to resolve th is disagreement and provide clarification on which 
rules would govern EU member States' interpretations  of the threshold so as to provide legal certainty 
and predictability to US stakeholders.   
47. Third, with respect to the SIEF issue, the Un ited States reiterated that many SIEFs were not 
functioning effectively for several reasons and ask ed what steps the European Union was taking to 
address these issues in time for companies to meet the first registration deadline.  The representative 
of the United States recalled its previously raised  concern that a formal contact group of trade 
associations had been set up to develop a strategy to help companies meet the first deadline but 
limited participation to EU stakeholders, excluding US and foreign stakeholders.  The United States 
expressed concern over how foreign stakeholder in put was going to be taken into account.     G/TBT/M/51  
 Page 13 
 
 
  48. The representative of the United States requested  clarification on a number of issues.  He 
requested an update on the latest developments w ith respect to the impact of REACH on animal 
testing.  Additionally, it was the understanding of the United States that while REACH called on registrants to submit their dossiers before the end of November, press reports claimed that ECHA had indicated it could guarantee processing registrations in time to meet the first registration deadline only 
if the dossiers were submitted by the end of June  2010.  The representative of the United States asked 
for clarification on this issue, including confir mation whether companies that had submitted their 
dossiers by the deadline at the end of November w ould fulfil their legal obligation to register and 
would be able to continue produci ng and importing their substances into the European Union.  If, in 
fact, ECHA had taken the position that the deadlin e was five months earlier than in the actual 
regulation, the United States felt this would put compan ies at risk of having to pull their products out 
of the EU market.  Such a significant change in th e policy would need to be codified in a formal 
proposal.  The United States understood the motivation in encouraging lead registrants to submit their dossiers early in order to limit last minute subm issions which would increase the chances that ECHA 
would not be able to process the registrations of th eir competitors in the SIEFs, many of whom where 
SMEs, in time for their products to remain on th e market.  He asked wh at the European Union 
intended to do, so that others could still submit them  in time, if the lead registrants did delay the 
submission of their dossiers.  He also noted th at the United States would submit comments by the 
1 December deadline regarding the upcoming review of REACH’s scope.  However, the 
representative of the United States asked whether there would be opportunities to submit comments 
on other aspects of the measure.   
49. The representative of Australia
 joined others in reiterating concerns about REACH.  While 
she stated her delegation's support of the objectives of  the European Union in ensuring a high standard 
of protection for human health and safety and for the environment, she noted that the overly burdensome and complex regulations unfairly impacted  non-EU producers, and in particular SMEs.   
She explained that non-EU companies continued to require further assistance from EU REACH 
experts to ensure they understood and complied fu lly with REACH requirements.  While Australia 
welcomed the development of the REACH guidance documents, the representative of Australia was 
concerned that these documents continued to be  subject to change leaving non-EU companies 
uncertain about REACH requirements and timelines.  
50. The representative of Saudi Arabia
 reiterated his delegation's c oncerns regarding the adverse 
impact of REACH on trade in chemicals.  He explained that the complexity of REACH made it 
difficult for Members to comply.  He explained, as an example, that the registration requirements for 
monomers and polymers, and for substances "int ended to be released unde r normal or reasonably 
foreseeable conditions of use" appear ed to be overly broad and needed to be clarified.  He shared the 
concerns raised by others that compliance with  REACH had created signifi cant costs and burdensome 
requirements for exporters to the EU market.  Fu rthermore, he expressed concern over the protection 
of business confidential information within REACH and asked what steps the European Union was 
taking to address confidentiality breaches.  Regardi ng penalties for non-compliance, the representative 
of Saudi Arabia asked for an explanation of th e penalties provided and an update on the lack of 
penalty provisions by some EU member States.  As a major exporter of chemicals, Saudi Arabia 
raised concerns that the requirements imposed by REACH in terms of its coverage, costs and procedures appeared to be more strict than  necessary to achieve the EU objectives.   
51. The representative of Cuba
 shared concerns raised by others regarding the costly 
requirements exporters faced.  He recalled a study by the European Parliament in 2006 that estimated 
that complete compliance with this regulation w ould cost Cuba Eur 2,780,000 per year during the 11 
year implementation period.  These were the sec ond highest costs that would be faced by an ACP 
grouped country, after South Africa.  He asked for clarity on the case of the Only Representative, the 
functioning of the substance information exchange  forum (SIEFs), the protection of confidential 
information, and the possible use of a different pr ocedure for the confirmation of pre-registration in G/TBT/M/51    
Page 14  
 
  each member State of the European Union.  He asked  the European Union to simplify the burden that 
this regulation represented for exporters, in particular fo r developing countries.   
52. The representative of Chile
 shared the concerns raised by Members regarding REACH.  She 
focused on four concerns.  First, in connection with  SIEF, she asked about the clause in the dates for 
availability of access, especially  for lithium carbonate and lithium hydroxide.  It was Chile's 
understanding that the access cards contained the tec hnical information, the physical data, and the 
toxicological characteristics which were necessary for registration.  She noted that, in practice, this 
information needed to be presented to ECHA at th e beginning of 2010.  However, it was unclear, as 
previously mentioned by the United States, whet her after 1 September 2010, before the official 
deadline of 1 December 2010; this information would not again be revised.  As such a situation could 
result in the non-compliance of Chilean compani es she requested more information about the 
deadlines, by the first week of July, to en sure the compliance of Chilean companies. 
53. Second, in connection with the implementation of REACH in sectors such as semi-finished 
steel products and steel products, which would be subject to the registration requirements, the 
representative of Chile noted that uncertainties exis ted regarding the pre-registration process.  While 
some may decide to enter into REACH provisionally, the ECHA authorities would have to look at the 
article and the respective SIEF would remain dorma nt.  She noted that Eurofair, the association 
comprising European steel producers, had different in terpretations of the issue to that of ECHA.  For 
example, Germany could consider semi-finished  products as finished products, thus falling under 
REACH, creating legal uncertainty.  She noted that different interpretations of REACH by the various 
EU member States would have an enormous  adverse effect on foreign companies. 
54. Third, the representative of Chile raised questi ons on classification, labelling, and packaging 
(CLP).  She explained that some EU companies were  not required to notify the classification of their 
products to ECHA until January 2011.  However, some  foreign companies that would not have come 
under the regulation for REACH registered substanc es would have had to comply with everything 
according to this legislation.  It remained unclear whether notification could be given, an issue that 
was raised as critical for Chilean  companies registered under REACH and subject to the CLP.  She 
asked for clarification on this issue. 
55. Fourth, the representative of Chile noted th at technical assistance for non-EU countries 
regarding both REACH and CLP, was almost non-existent.  Explanatory notes on the internet were useful, and a formal request for training procedures existed, but she suggested video conferencing could also be used.  Additionally, she asked for information on what the European Union was doing 
regarding confidentiality breaches, referring to a case where registered Chilean companies received 
unsolicited emails from a consulting firm.  Fina lly, she noted her delegation's support for the 
statement that would be ma de on behalf of GRULAC. 
56. The representative of Thailand
 echoed the concerns raised by others on the difficulties SMEs 
had had in complying with REACH.  While Tha iland supported the objective of human health and 
environmental protection, the representative of Tha iland urged the European Union to consider ways 
to ensure that the measures was not more trade restrictive than necessary. 
57. The representative of El Salvador  made a statement on behalf on the Group of Latin 
American and Caribbean countries (GRULAC).  GRULAC recognized the right of Members to 
establish technical regulations on procedures to evalua te conformity based on scientific evidence with 
a view to protecting human health and the environm ent.  However, she explained that the complex 
nature and costs involved in the process, and the lack  of precise information, particularly in Spanish, 
represented unnecessary trade barriers particularly to SMEs.  She requested th at the European Union 
offer prompt and effective technical assistance as pa rt of special and differential treatment to SMEs.   G/TBT/M/51  
 Page 15 
 
 
  She stated that GRULAC reserved its right to come back to this measure with new concerns in the 
future.   
58. The representative of the European Union  responded to the questions and comments raised.  
She reminded India that an explanation about the rationale and objectives of REACH had been 
addressed in previous Committee meetings.  Rega rding Argentina's statement that the businesses 
outside the EU had to open an office within the Eur opean Union or hire a single representative she 
noted that it was not correct that the appointment  of an Only Representative was mandatory, since 
REACH only applied to importers in the European Union.  As the importer was the one responsible 
for registration, an Only Representative was only necessary when third countries' manufacturers did 
not want to provide the necessary data to the importers. 
59. Next, she noted that the polymer and monomer question had been resolved by the European 
Court of Justice which had confirmed that article 6 paragraph 3 of the REACH regulation, which had 
provided for the registration of reacted monomers in polymers, was valid.  It was found that the registration obligation enabled bette r knowledge to be obtained of pol ymers and address certain health 
and environment risks such as monomer residues.   
60. The representative of the European Union went on to suggest that instead of repeating the 
same issues in every Committee meeting, she woul d focus on issues of current relevance for the 
REACH Regulation, and especially on those regardi ng the first registration deadline of 30 November 
2010.  She explained that the functioning of the SIEF was a priori  the responsibility of industry.  
However, the European Commission and ECHA had c ontinued efforts to help industry in making the 
SIEF function.  Additionally, an ECHA Stakehol der Day had taken place 19 May 2010 regarding the 
registration deadlines; she noted that informati on from the day was available on the internet.
2  S he 
informed the Committee that the next ECHA Stakeholder Day, which would be held on 4 
October 2010, would focus on registration and the sec ond step of the dossier evaluation; it would 
again be open to all stakeholders and accessible online.   She explained that a couple of "webinars" had 
also occurred, providing information on how to prep are a registration dossier and submit to ECHA.  
The recordings for these webinars had been published.3  Additionally, a new practical guide (number 
9), on how to do registration as a member who joins a submission, was also available on the website.4   
She stated that these readily available tools were a form of technical assistance, meant to assist both 
EU and non-EU manufacturers.  Other information was also specifically addressed to SMEs, to assist 
them in complying with REACH.  She stressed th at if countries had specific training needs, they 
could contact the EU delegation in their territory.   
61. Regarding the functioning of the SEIFs and the upcoming registration deadline, the 
representative of the European Union noted that a Di rectors' contact group, chaired by the European 
Commission, had developed certain practical r ecommendations, including on issues of importers and 
Only Representatives.  These recommendations we re first communicated by ECHA on 16 April 2010, 
and more recommendation would be ma de public in the future.  One recommendation was to the lead 
registrant to set a cut-off date in order to avoid the situation where companies that did not participate 
in the SIEF discussions, submitted important information at the very last moment, disrupting the planned submission.  This recommendation was meant to address concerns, also raised by Members at the TBT Committee meeting, that cer tain participants were dormant in the SIEF, by encouraging 
companies to start work now on coll ecting the data needed so that th e lead registrant could submit the 
dossier correctly.  The representative of the Europ ean Union explained that this contact group had 
been set up rapidly and thus had not involved EU me mber States or foreign countries.  However, all 
recommendations were made public and if foreign co untries were interested to be represented by the 
                                                     
 
2 http://echa.europa.eu/news/events_en.asp. 
3 http://echa.europa.eu/news/webinars_en.asp. 
4 http://echa.europa.eu/doc/publications/practical_guides/pg_9_reg_member_subm_rev11_en.pdf. G/TBT/M/51    
Page 16  
 
  International Chemical Council Association join ing, the European Union would be open to 
discussions.  She noted that followi ng these recent efforts, the number of lead registrants that had 
registered had again increased, to 2574 by mid-June.   
62. Regarding the concerns from Chile that a consu lting firm had contacted other participants in 
the SIEF, the representative of the European Union noted that the issue had been raised before and 
that steps had been taken in this regard: ECHA ha d reacted with a press release dated 30 July 2009.  
Regarding Chile's other questions, she mentioned th at her delegation would follow-up bilaterally.   
63. Next, she explained that on the ECHA website, a list was now available of all chemicals that 
companies had indicated as being planned to be registered by 30 November.  She asked Members to pass this information on to their industry so that ma nufacturers, particularly downstream users, could 
consult the list and check to make sure that thei r substances, which had to be registered by 30 
November, were included in the list.  This was impor tant since if a substance had not been registered, 
it would be illegal to manufacture or sell it in the European Union.  She explained that the list would 
be updated regularly.  
64. Regarding Canada's reference to the new A nnex V guidance, the representative of the 
European Union explained that this guidan ce had been published on 1 April 2010 and provided 
explanation and background information on how differe nt exemptions from the obligations to register 
applied.  With the completion of this guidance, all guidance documents important for the registration 
deadline of 30 November were available, with mo st of them being available in all 22 EU member 
State languages, including Spanish.  Regarding when  the guidance would be revised, she stated that 
those relevant for registration would not be ame nded before 30 November 2010. In fact, ECHA had 
taken the decision to postpone amendments to 10 gui dance documents in order to give companies and 
industries time to focus on registration until 30 November.   
65. With regards to the 0.1 per cent issue and me mber States' different interpretations, the 
representative of the European Union noted that in  consequence no update of the guidance documents 
was planned for the moment. She referred to the last EU statement made in the TBT Committee 
where it had been explained that a final interpre tation of the REACH Regula tion could only be given 
by the European Court of Justice.  Addressing Saudi  Arabia's request for an update on the absence of 
sanctions in certain Member States, she noted that there was only one member State who had not yet adopted sanctions for its whole territory, but all others had done so. Regarding the US question on 
animal testing, she referred Members to the ECHA press release on a new practical guide on avoiding animal testing, published on 2 June 2010.   
66. The latest developments regarding the candidate  list and the substances to be included in 
Annex 14 were outlined next.  The representative of the European Union recalled that at the last 
Committee meeting there had been 29 substances on th e candidate list and that ECHA had identified 8 
new potential substances of very high concern, w ith public consultation on-goi ng.  As of June 2010 
there were 38 substances on the candidate list: th e 29 substances already of the list, acrylamine which 
was added after a court case, and the eight new s ubstances which had still been under consolation at 
the time of the last TBT Committee meeting.   
67. Regarding Japan's question on the relation of the REACH Regulation with the RoHs 
Directive, she stated that these two Directives were being applied in parallel.  She further explained 
that there was no overlapping, as referred to by Japan, since Articles 7 and 33 of REACH referred to 
information requirements while Article 4 of the Ro Hs Directive referred to restrictions.  Also, 
regarding the potential overlapping of regulations, she stressed that the European Commission would 
review the scope of REACH (done in accordance with  Article 138 paragraph 6 of REACH) by 1 June 
2012 in order to assess whether to amend the scope to  avoid overlaps with other relevant Community 
provisions.  She noted that the review was alread y underway, and that stakeholders were being  G/TBT/M/51  
 Page 17 
 
 
  provided with the opportunity to share any relevant  experience they had re garding overlapping scopes 
or gaps between REACH and other EU legislation.  A website had been created to receive comments, 
www.reachscope.eu, and would be operational until 1 December 2010.  She invited Members to 
submit comments. 
68. Finally, she updated the TBT Committee on the draft regulation amending Annex XVII of the 
REACH Regulation (notified under G/TBT/N/EEC/297)  which had been mentioned at the last 
meeting.  She stated that similar to the situation at  the time of the last meeting, the proposal was still 
under review and had not yet been adopted.  The on ly development to report was that the European 
Commission and EU member States were current ly analyzing the opini on of the ECHA Risk 
Assessment Committee, on the use of bori c acid in photographic applications.  
(ii) European Union – Directive 2002/95/EC on the Restriction of the Use of certain Hazardous 
Substances in Electrical and Electronic Equipm ent (RoHS) and Directive 2002/96/EC on 
Waste Electrical and Electronic E quipment (WEEE) (G/TBT/N/EEC/247 and 
G/TBT/Notif.00/310, Corr.1) 
69. The representative of Japan  understood that in the draft amendment of the RoHS Directive 
2002/95/EC, Article 4 on Prevention had been transfe rred to Annex IV, and ne w candidate substances 
were listed in Annex III.  Japan sought confirmation that Annexes III and IV were indeed part of 
Directive 2002/95/EC, thereby requiring the European  Union confirmation on the procedures for the 
insertion or deletion of listed items in the annexes.  Japan requested that th e European Union notify 
any schedule of amendments to Directive 2002/95/EC. 
70. The representative of the Republic of Korea  welcomed the exclusion of brominated flame 
retardants (BFRs) and PVC from the RoHS Annex IV  list of restricted substances.  However, the 
representative of Korea expressed concern that DEHP, DBP, BBP and PVC remained on the Annex III Priority List.  Their inclusion could present incorre ct signals of their dangers to many stakeholders, 
especially non-experts.  The Republic of Korea was of  the opinion that the risk s associated with these 
substances required vigorous scientific investigati on.  Until investigative results were generally 
approved, they requested the European Union to exempt the proposed substances from any list.   
71. The representative of the United States
 reiterated his delegati on's support for the RoHS 
objective for protecting health, safety and the envir onment, but trade-related concerns remained.  If 
adopted the proposal would likely impact upon many producers.  The United States therefore sought 
an update from the European Union on  what consideration was being given, as part of the process, to 
the input provided by producers and other stake holders.  Although the representative of the United 
States recognized the Commission's efforts on in formation gathering in order to inform the 
development of its proposal, including through impa ct assessment, he believed that had a thorough 
impact assessment been conducted, it would have b een a useful tool to have better informed the 
Council and Parliamentary scope proposals.  This in turn could have led to a very different outcome 
by the Environment Committee.  The United States continued to hear concerns from stakeholders 
about the proposals for an open scope as, for exam ple, the current proposal’s not clearly defining 
excluded categories. 
72. European Union efforts to articulate the relationship between REACH and RoHS, through 
their proposal for a revised RoHS Directive, was acknowledged by the United States.  Nevertheless, 
they were of the view that the text could benefit fro m greater clarification.  It was noted that the new 
substances identified in their proposal, itemized s ubstances which might also appear on the REACH 
candidate list of substanc es of high concern for authorization and subject to REACH assessment.  If 
the purpose of a link with REACH was to align a pproaches, the US concern was that evaluation 
conclusions would differ – given that the same substance would be evaluated under two separate 
measures, by different agencies, having differe nt objectives and using different criteria.   G/TBT/M/51    
Page 18  
 
  73. The United States requested the European Union to elaborate on the timeframe for revising 
the RoHS Directive.  A REACH process for discu ssing scope issues existed and many stakeholders 
would want to submit specific comments on the re lationship between REACH and RoHS, prior to the 
December timeframe.  Should the recast process co mplete before December, any comments could 
prove to be moot.  
74. The United States held the view that the opera tion of the RoHS Directive would be improved 
through a transparent exemption process that provi ded fixed timeframes for decisions; a meaningful 
opportunity for all interested parties to comment; a nd an explanation of the basis for decisions.  The 
United States voiced its concern that given the poten tially wider scope of the measure, as the number 
of exemption requests would likely increase, and Eu ropean Union resources might not be adequate. 
The United States held the view that the operation of the RoHS Directive would be approved through 
a transparent exemption process that provided fixed timeframes for decisions; a meaningful 
opportunity for all interested parties to comment; a nd an explanation of the basis for decisions.  The 
United States voiced their concern that given the potentially wider scope of the process, as the number 
of exemption requests would likely increase, Eu ropean Union resources might not be adequate. 
75. With respect to additional substances, the Un ited States urged that any decision to include 
additional substances be science-ba sed, taking into account any end-uses and all available scientific 
and technical information with respect to substa nces not currently restricted and for which the 
Environment Committee had called for further evalua tion.  As well as for those substances for which 
the Committee had called for a ban, the United Stat es requested information on the identified potential 
risks to health and the environment, together w ith information on the processes through which those 
risks had been identified.   
76. The representative of China
 reiterated that his delegation had repeatedly raised concerns on 
both European Union Directives, bilaterally and within the Committee.  He acknowledged previous 
speakers for raising issues and registered China's continued concern with regard the directives and 
their implementation developments. 
77. The representative of the European Union  informed the Committee that the proposal was in 
the first reading of the legislative process by th e European Parliament.  The Environment Committee 
had adopted its report on the Commission proposal on 2 June 2010.  The report retained 160 of the 
300 amendments tabled by parliamentary members w ithin different parliame ntary committees.  The 
report of the Environment Committee was to be discussed at a plenary session of the European 
Parliament in October 2010.  It was expected that during that session, the Parliament would adopt its 
opinion on the Commission's proposal.  The next st age of the procedure would be a discussion in 
Council by the European Union Member States on the text voted upon by the Plenary.  The EU 
Member States would review the amendments and indicate whether they were agreeable.  If 
agreement was found between the Parliament and Council, and should the Commission agree, the 
legislative process would conclude with the finaliza tion of the text.  If a compromise could not be 
reached the text would be re-submitted to Par liament and Council for examination under a second 
reading. 
78. Regarding substance, the Environment Comm ittee had indeed proposed extending the scope 
of RoHS to all electrical and electronic equipm ent, including cables, consumables and accessories 
until 1 July 2014.  The Environment Committee had also proposed certain exclusions from RoHS, in 
particular means of transport; large-scale fixed inst allations; and equipment manufactured for research 
and development purposed.  They had also proposed  changes to the ways and rules through which 
exemptions were granted.  It was noted that  the Environment Committee had not retained the 
amendment aimed at enlarging the number of substances that would be restricted under RoHS, but  G/TBT/M/51  
 Page 19 
 
 
  rather proposed enlarging the substances list in Annex III5 by adding 29 candidate substances from the 
REACH candidate list.   
79. Which amendments would survive the plenary vote  remained unclear and, in the view of the 
European Union, it would be premature to surmise on any amendment.  Within the legislative process 
the Commission would signal concerns raised by WTO Members to the Parliament and to the 
Presidency of the Council of the European Unio n.  The representative of the European Union 
informed WTO Members that should the Commission' s initial proposal be substantially amended, the 
revised text would be notified to the TBT Commi ttee.  Also, WTO Members will be updated on 
developments of the legislative process at the next meeting.   
(iii) European Union – Regulation on Certain Wine Sector Products (G/TBT/N/EEC/15, Corr.1-2, 
G/TBT/N/EEC/57 and G/TBT/N/EEC/252 and Add.1 and Add.2;  G/TBT/N/EEC/264 and Add.1)   
80. The representative of the United States
 informed the Committee that it continued to have 
serious concerns regarding European Union measures that severely restricted the ability of non-
European Union wine producers to use common or descriptive and commercially valuable terms that 
the EU claims are traditionally associated with Europ ean wines.  This was particularly problematic as 
some terms had no common definition across all European Union member States, and to their knowledge no efforts had been undertaken to mon itor or limit the use of those terms within the 
European Union.  Negative trade impacts remained a concern, along with previously raised issues, 
and discussion continued with stakeholders. 
81. The representative of the United States unders tood that discussions between the EU and 
industry were ongoing with respect to several te rms upon which the European Union continued to 
claim exclusive rights, citing the recent example of  the United States Government and industry filing 
objections to Cyprus' request that the English term 'special reserve' be designated as a traditional term.  
Cyprus' application provided no indication that the E nglish term 'special reserve' is a name used 
widely within the Community, nor a reputed name in  Cyprus.  The United States queried whether this 
application may have been prompted by a recent European Court of Justice ruling that found that 
traditional terms were now protected in languag es other than the one for which protection was 
originally identified.  Further, the United States requested the provision of an update on the discussion 
over specific terms and how the European Uni on intended to address the request from Cyprus. 
82. The representative of the European Union
 acknowledged the continued interest by the United 
States in European Commission wine labeling legislation, noting that their authorities were in regular contact with Wine of America, the National Associ ation of American Wineries. The European Union 
had provided the necessary information to EU indus try in order to assist them in submitting their 
application. It was noted that the Commission wa s currently examining both the application by 
Cyprus and the comments received, incl uding those from the United States. 
(iv) India – Pneumatic tyres and tubes for autom otive vehicles (G/TBT/N/IND/20 and Add.1; 
G/TBT/N/IND/40 and Rev.1)   
83. The representative of the European Union
 voiced appreciation to India for their recent 
decision to postpone implementation of the new Indian Order on Tyres and Tubes for Automotive 
Vehicles for an additional six months.  Nonetheless,  the European Union remained concerned that 
tyres produced according to United Nations Economic  Commission for Europe (UNECE) Regulations 
were not considered as equivalent.  Moreover, the European Union had some concerns regarding the 
                                                      
5 Annex II contains a list of substances presenting potential environmental risks when used in electrical 
and electronic equipment and for which a priority assessment is proposed by the Commission. G/TBT/M/51    
Page 20  
 
  implementation of the Order.  The European Union had been alerted by economic operators that the 
burdensome certification procedure had made it extremely difficult to receive necessary certification within the required timelines.  For instance, de tailed information was requested concerning raw 
material, manufacturing machinery, the name of the maker, the number of installed machines, as well 
as test equipment.  The European Union sought clar ification as to why the Indian authorities required 
this information.  Furthermore, applicants were re quired to pay a royalty fee calculated on all tyres 
marked with the Indian logo, whether imported or no t, obliging economic operators to either pay high 
fees or produce tyres for the Indian market alone.  The European Union urged India to ensure that the 
calculation on which royalty fees was based was on th e total value of actual imports to India.  
Additionally, India was urged to accept test results from UNECE accredited laboratories. 
84. On certification, the European Union sought cl arification that the procedure required tyre 
manufacturers to have complete in-house testing facil ities.  The European Unio n had been alerted that 
certain applications from economic operators had been rejected on this basis.  Clarification was sought as to what type of testing such in-hou se facilities would perform and whether they would 
complement tests by the Bureau of Indian Standard s (BIS) accredited laboratories.  In the view of the 
European Union, all above-mentioned elements cr eated unnecessary obstacles to trade and were not in 
compliance with the TBT Agreement.  Therefore Indi a was urged to take the necessary steps to ensure 
their procedures were less burdensome and more  cost effective for economic operators.   
85. The representative of Japan
 stated their regret that India had expanded the scope of tyres 
targeted by this Regulation.  Japan's concern was that the Regulation contained considerable 
uncertainties, creating a barrier to trade of tyres and tubes.  It was pointed out that a TBT Notification 
on the expansive revision of the Regulation should ha ve been submitted.  Due to the revision, many 
additional plants would require a udit applications.  The representative of Japan requested India to 
further postpone the implementation of  the Regulation so that industry had sufficient time to prepare 
for the revision.  Regarding the BIS Indian Standards Institution (ISI) mark, it was Japan's 
understanding that the Regulation required manufacturer s to pay license fees for all ISI marked tyres, 
including those exported outside India.  They pointed out that the license payment obligation needed to be limited to tyres imported to India. 
86. The representative of the Republic of Korea
 stated that notwithstanding the welcome 
postponement of the Regulation, several concerns remained.  On the obligatory ISI marking of tyres (Article 3.1), they again called upon the Indian au thorities to consider the significant amount of time 
expended and the increase in costs for both manufact urers and consumers.  They reiterated that these 
concerns could be eliminated by the acceptance of international marks of conformity.  On the 
requirement of information disclosure (Article 5), th e Republic of Korea remained of the view that the 
necessity for confidential information needed to be  made exempt.  Korea had serious concerns over 
the leaking of manufacturers' confidential i ndustrial and technological information.   
87. The representative of India
 stated that in extending the Regulation timeframe to 
November 2010, they had provided more time than th at stipulated by the TBT Agreement.  On the 
non-acceptance of international standards, the represe ntative of India informed the Committee that the 
BIS had undertaken comprehensive analysis of not only UNECE standards, but those of the 
International Organization for Standardization (ISO)  and American Standards (ASTM) as well.  They 
believe the ISO to be a relevant international standards-setting body, whose benchmarks had framed 
this Regulation.  With regard to royalty fees, th e representative of India informed the Committee that 
the fees had recently been amended by BIS to ensure that the unit value of the fees were equivalent 
for both the domestic and import markets.    G/TBT/M/51  
 Page 21 
 
 
  (v) European Union – Regulation on Classificati on, Labelling and Packaging of Substances and 
Mixtures (ATPs and CLP) (G/TBT/N/EEC/ 151 and Adds.1-2; G/TBT/N/EEC/212 and Adds.1-
3; G/TBT/N/EEC/163 and Adds.1-2, Add.1/Corr.1)  
88. The representative of Brazil  reiterated his delegation's concer ns regarding the first adaptation 
to technical progress (ATP) to the EU regulatio n on Classification, Labelling and Packaging of 
Chemical Substance (CLP Regulation).  Brazil cons idered that the classification of nickel compounds 
under the first ATP had been based on an inadequate application of read-across methodology.  It was 
the view of Brazil that major flaws in the process ha d been related to the absence of data, the criteria 
used to group substances, and the disregard to some OECD recommendations on read-across.  The 
representative of Brazil recalled that, on previous occasions, that European Union had informed the 
Committee that the first ATP would only have imp lications for the labelling of nickel compounds.  
However, the classification of nickel compounds as  carcinogenic had led to additional restrictions 
under other EU Regulations such as  REACH.  Brazil was concerned th at this new classification would 
have significant commercial effects which w ould go beyond the labelling requirements.  
89. The representative of Brazil expressed his delega tion's regret that the European Union had not 
provided adequate opportunity for Members to comme nt on the first ATP, noting that the difference 
between CLP and DSD regulations justified a new c onsultation period for the first ATP.  Due to the 
fact that a comment period had not been granted, Br azil was of that view that important transparency 
flaws existed in the process of elaborating and pub lishing the first ATP to the CLP.  While Brazil did 
not dispute the EU's objective of protecting human  health and environment, it did dispute the 
necessity of the measures used for achieving those legitimate objectives as there was no sound 
scientific evidence on the risks posed  by the reclassified nickel compounds.  The representative of 
Brazil stressed his delegation's concern regarding th e compatibility of the first ATP with Articles 2.2, 
2.4 and 2.5 of the TBT agreement. 
90. The representative of Canada  raised her delegation's longsta nding concerns with the EU's 
classification of nickel containing substances.  She recalled that at the last TBT Committee meeting, 
Canada had circulated a Room Document which cont ained a list of concerns and questions regarding 
the issue.  She thanked the European Union for th eir response in mid-May.  Additionally, she noted 
that Canadian officials were also currently re viewing EU comments received 9 June 2010 regarding 
document G/TBT/N/EEC/297.  It was Canada's view that given the potential of a negative impact on 
nickel producers and exporters, it was essential that  any classification of substances be based on 
transparent, sound science.  The same  principles needed to be applied to measures that relied on these 
classifications.  Regarding Borates, the representative of Canada noted the concerns raised by other 
Members regarding the proposed identification of Bo ric Acid as a Substance of Very High Concern 
(SVHC) and explained that Canada also had an inter est in resolving such concerns, ensuring that the 
assessment and management of substances were scien tifically based, conducted in an appropriate and 
transparent manner, and proportionate to the risk that substances posed.  She expressed Canada's 
interest in the EU's proposed classification of borates and the perceived risks associated with 
inhalation exposure in the workplace and asked what  other risk management options the European 
Union had considered.  
91. The representative of Turkey  maintained its position on the classification of borates with 
regard to the lack of legal and scientific basis.  He expressed concern with recent steps taken in the 
classification of borates.  It was Turkey's understanding that the classification was based of the 
evaluation of hazard and the determination of con centration limits with respect to danger for human 
reproduction.  Therefore, when limits were not ex ceeded, it was presumed that substances would not 
damage human health. Similarly, he explaine d that exceeding concentration limits did not 
automatically lead to risk.  He noted that besi des authorization (Annex XI V) and restriction (Annex 
XVII), lists under REACH were determined according to risk analysis.  Whil e there where no other 
borates products exceeding the concen tration limits or which were found to pose a risk to consumers, G/TBT/M/51    
Page 22  
 
  the downstream impact had been to add borates to  Annex XVII of the REACH regulation and Annex 
XV dossier to add borates to the candidate list.  He st ated that it did not seem plausible to rush for the 
restriction of borates since there were no borates sold to  consumers that posed a risk.  He noted that as 
time passed and new studies on the chemicals we re undertaken, the issue was becoming more 
complicated.  He asked the EU to re-evaluate th is issue in light of these new concerns and new 
studies.  
92. The representative of the United States
 reiterated his delegation's concerns on the initial 
classification of certain borate and nickel compounds  under the Dangerous Substances Directive and 
their translation into the CLP regulation.  With resp ect to borates, the United States noted that, in light 
of the risk assessment commissioned by the Europ ean Union, borates usag e, in the cases examined, 
posed either a negligible or non-existent risk to the general public.  As a result, the European Union 
had initially proposed that the placing on the market and use of borates containing substances in household cleaners, detergents and certain photographi c mixtures would not be restricted.  However, 
due to member State disagreement, the European Union had not adopted this exemption. It was the understanding of the United States that this issu e had once again been re ferred to ECHA's risk 
assessment committee, which had found that norma l use of photographic compounds was safe.  The 
representative of the United States asked what wo uld happen with the results of the initial risk 
assessment which resulted in the EU proposal, and whether the European Union would go forward in 
placing restrictions on these substances despite the results of the risk assessment.  He urged the European Union to adopt a risk-based approach to determining exemptions for the use of products.  
93. With respect to the recent decision to place certain boric compounds on the candidate list, the 
representative of the United States asked whether the results on the Chinese mine workers study, as 
well as other studies submitted by the European Bora tes Association, would be taken into account.  
He noted that the consideration of the available scientific and technical information was pivotal in 
assessing the risks of non-fulfilment of legitimate objec tions.  He also noted that the effects of the 
initial boric classification under other EU measur es, many of which were discussed in earlier 
Committee meetings, appeared to have been c onfirmed by this new decision to place these boric 
compounds on the list.   
94. With respect to nickel, the representative of th e United States noted that the Danish competent 
authority appeared to not have completed a ll the necessary steps of the OECD read-across 
methodology, raising questions about whether the av ailable scientific and technical information and 
intended end-uses had been taken into account.  It was the understanding of the United States that the 
European Union believed that certain provisions pr ecluded the following of the necessary steps.  The 
representative of the United States asked for clarif ication on the exact provisions of the Dangerous 
Substances Directive that prevented the European Un ion from following all of the steps of the-read 
across methodology and whether provisions of the CLP regulation and other EU legislation would 
prevent them from following all of the steps of th e read-across methodology for future analysis of 
substances.  Additionally, he asked what the effect s would be regarding the interpretation of the EU's 
ability to take into account the available scientific and technical information and intended end-users to 
evaluate substances.  He noted that the United Stat es would continue to monitor the potential adverse 
trade impacts of these classifications and methodological issues. 
95. The representative of Thailand
 shared the same concerns raised by others regarding nickel 
classification.  She stated that whether for health, saf ety, or consumer protection, it was important that 
the classification  be based on scientific justificati ons.  She asked the European Union to ensure that 
its substance classification was based on unquestiona ble and solid scientific findings and procedural 
thoroughness.  
96. The representative of the Dominican Republic  recalled her delegation' s concerns about the 
EU decision to reclassify nickel carbonate and ot her nickel compounds in the new regulation on  G/TBT/M/51  
 Page 23 
 
 
  classification, labelling and packaging CLP of the Eur opean Union.  She stressed that there had been 
no scientific basis to the first change to the ATP, in effect since 25 September 2009.  The Dominican 
Republic regretted that the European Union had not  taken their comments, as well as the comments of 
several other delegations at the TBT Committe e meetings in 2008, 200 9 and March 2010, into 
account.  
97. She reiterated her delegation's concerns with  respect to the methodology used by the 
European Union to classify nickel substances know n as read-across.  The Dominican Republic was 
also of the view that the European Union had vi olated Article 2.2 of the TBT Agreement, which 
established that Members should ensure that they  would not draw up, adopt or apply technical 
regulations that would have the effect of creati ng unnecessary barriers to trade.  The classification and 
labelling requirements in this re gulation would have adverse conse quences for the nickel substance 
producers and exporters.  The representative of the Do minican Republic recalled that in 2007, nickel 
ion exports from the Dominican Republic represented mo re than 50 per cent of national exports, with 
an absolute value of US$1.153 billion.  However, du e to a fall in the international prices, in 2008, 
only US$492 million in exports were registered.  Th is had a devastating eff ect on the industry and the 
national economy.  In November 2009, the company that mined nickel ion in the Dominican Republic 
dismissed more than 900 employees and was no longer in  operation.  She noted that nickel ion mining 
in the Dominican Republic took place in very depressed areas of the country where no other sources of labour or employment existed.  The new EU regu lations would have made this situation worse.  
She asked the European Union to reconsider its pos ition and to comply with the provisions of the TBT 
Agreement.  
98. The representative of Ecuador
 shared the concerns raised by Brazil and others on the lack of 
transparency so far in the adoptio n of the first ATP and the need fo r the European Union to explain 
the scientific basis for the reclassifi cation of nickel components CLP.  
99. The representative of Colombia  recalled that the scientific basis for this classification had 
been debated at length in the Committee.  He noted  that there had been no scientific certainty with 
respect to the validity of the measures and provisions adopted and that there was no proof of 
effectiveness with regards to the le gitimate objective of the regulation.  
100. The representative of Cuba  repeated his delegation's concerns with the classifications adopted 
by the European Union for more than one hundred  nickel compounds.  He expressed that Cuba was a 
faithful defender of human health, the environment and regulations adopted to this end, as long as 
they were scientifically based.  He noted, however, th at there had been no data or scientific evidence 
that justified the classifications in the EU regulation.   He noted that the EU's methods had been based 
on extrapolation, and while Cuba had not been op posed to the use of this methodology, in this 
particular case, it had not followed international scien tific practice as it had omitted steps 5 to 8 of the 
OECD guide.  Furthermore, it was the view of Cuba  that the procedures of the European Union were 
not the most appropriate in terms of the obligati ons under the TBT Agreement.  He noted that the 
European Union did not take note of the multiple a ppeals to extend the 60 day term to look at the 
requests formulated by various Members, including developing countries.  It was the view of Cuba 
that the European Union had not considered the Committee's decision at the Third Triennial Review, 
that developed country Members would provide a te rm of more than 60 days for the presentation of 
comments in order to improve the capacity of de veloping countries and to accommodate the special 
and differential treatment clause.  Instead, the classifications had been adopted by the Committee on 
Technical Progress on the day of the Committee ju st after the expiry of the deadline.  
101. The representative of Cuba noted that while the impact of this system of classification for the 
nickel industry at the global level was still incalcu lable, it would cause discrimination against nickel 
compounds in addition to adverse effects for the mark eting the product.  Because of this, there were 
various regulations on protective measures and restri ctions and prohibitions on the use of classified G/TBT/M/51    
Page 24  
 
  substances, including REACH.  In Septembe r 2009 the European Union notified a proposed 
amendment to REACH which prohibited the sale of a series of classified substances under the regulation as carcinogenic or toxic for reproduction,  including nickel compounds.  Adding negative 
press to this, these classifications could have had a possible domino effect in other markets.   Cuba urged the European Union to provide satisfactory rep lies to the following questions:  (i) how did they 
justify the omission of steps 5 to 8 of the extrapolation methodology or read-across from the OECD; 
(ii) would they facilitate the opinion of experts or information on which the classifications were 
based; (iii) did the European Union have data on the water solubility of each one of the nickel 
compounds included in ATP; and (iv) what specif ic information would have made the European 
Union reconsider this system of classification, give n the lack of sufficient scientific basis.  Cuba 
sustained that the classification for nickel compounds  adopted by the European Union constituted an 
unnecessary barrier to trade and asked the Eu ropean Union to revise the first ATP. 
102. The representative of Australia
 reiterated her delegation's concerns and disappointment 
regarding the EU's decision to reclassify a range of nickel compounds, noting that the concerns of 
many WTO Members remained unaddressed.  Austra lia recognized the importance of ensuring the 
protection of human health and the environmen t, and therefore supported the development of 
transparent and sound measures to achieve such protec tion.  However, the scientific validity of the 
EU's decisions to reclassify the nickel substan ces remained of concern.  The representative of 
Australia noted that the competent Australian ass essment authority had been discussed at past 
meetings and that concerns along those lines continue d to be raised.  She noted that Australia had 
previously welcomed European Union assurances in the TBT Committee that the EU's decision to 
reclassify the nickel substances would result only in additional labelling requirements and that, as a 
result the impact on trade in these substances woul d be limited.  However, there was now evidence 
that there would be a significant impact on trade in  nickel compounds resulting from the EU decision.   
In this regard, she understood that: the propo sed EC Green Public Procurement Criteria would 
exclude the use of stainless steel containing more th an 1 per cent nickel in air conditioners and heat 
pumps; under the revised EU Eco-Label Directive, products incorporating alloy steels and stainless 
steel containing 1 per cent or more nickel would no t be eligible for an EU Eco-label;  EU mobile 
phone producers may be looking to suspend the use of nickel in anti-radiation barriers, and the 2008 London Olympic Games Sustainable Sourcing Code liste d nickel, in relation to battery applications, 
as a material to be avoided. 
103. She further noted that amendments to Annex XVII of REACH would have further prohibited 
the sale of nickel substances to the general pub lic and would have required these substances and 
mixtures to be labelled as ‘restricted to profession al users'.  The consequences of this proposed 
amendment for nickel producers and users would ha ve been far-reaching and would have confirmed 
Australia's concerns, as previously raised in th e TBT Committee, that the reclassification of nickel 
substances as category 1 and 2 carcinogenic and mutagenic compounds would trigger a series of 
downstream regulatory requirements which would im pose additional restrictions and prohibitions on 
the use of nickel substances. 
104. Australia welcomed assurances that a risk assessm ent would need to be carried out before the 
European Union sought to impose any type of marketing restrictions, or the setting of maximum exposure levels or bans would be  considered.  The representative of Australia noted that a risk 
assessment had been conducted for borates, resulting in  the exemption of some borates for certain end 
uses from the proposed prohibition on sale to cons umers, although the United States was continuing 
to face problems.  However, it was not apparent th at a similar risk assessment had been conducted for 
nickel substances.  Further, Australia understood, fro m consulting with their industry, that only three 
of the numerous nickel substances proposed to be included in Annex XVII were  used by consumers.  
As a major producer and exporter of nickel substances  Australia continued to be greatly concerned by 
the likely significant economic impact on nickel producing and exporting countries, which included  G/TBT/M/51  
 Page 25 
 
 
  developing countries, of the EU's decision to reclassi fy the nickel substances and to further restrict 
their use. 
105. The representative of Saudi Arabia  shared the concerns expressed by other Members that the 
requirements imposed by the EU Regulation on Classifi cation, Labelling and Pack aging of Substances 
and Mixtures appeared to be more strict than n ecessary to achieve the European Union's objectives.  
Saudi Arabia saw the coverage, costs, and procedur es set out in the Regulation as evidence of this.  
The representative of Saudi Arabia explained his de legation's concern about the scientific assessment 
under the Regulation.  He explained that it was im perative that any such classification be based on 
internationally recognized science and reliable data, as well as transparent expert assessment 
procedures, pursuant to the requirements of the TB T Agreement.  Like other Members, Saudi Arabia 
was concerned that the labelling of chemicals under the regulation coul d be misconstrued or 
misunderstood as an eco-labelling scheme.  Like REACH, this Regulation could have significant 
adverse trade effects.  Saudi Arabia was concerned that this Regulation entailed excessive requirements and would result in unnecessary additi onal costs for the industry.  Saudi Arabia 
requested the European Union to en sure the consistency of the regulation with the requirements of the 
TBT Agreements.   
106. The representative of China
 joined the previous speakers by stressing his delegation's concern 
with the EU measure, in particular regarding th e omission of the OECD read-across steps by the 
Danish research group, which could lead to incorrect  results in terms of the classification of nickel 
compounds.  This could have brought significant adver se trade effects in sever al areas as illustrated 
by the delegation of Australia.  The representative of China invited the European Union to base its 
measures on solid and credible scientific evidences, in  line with the least trade restrictive obligations 
of the TBT Agreement. 
107. The representative of the European Union  took note that a number of  delegations continued to 
raise concerns over the classification of borates and several nickel compounds in the 30th and 31st 
ATP.  She noted that these concerns would be conve yed to capital.  She explained that, over the last 
years, the European Union had provided detailed repli es, in writing and orally, to all of the issues 
raised in this meeting.  Add itionally, presentations by EU expert s had been given at TBT Committee 
meetings.  Given that there was nothing new to add, she referred Members to the minutes of the last TBT Committee meetings for more details.   
108. Regarding the question from the United States to d escribe the legal basis in the EU legislation 
which prohibited the European Union to carry out add itional testing, she explained that this had been 
article 4.3 of the Dangerous Substances directiv e and article 8 of the CLP regulation.  These 
provisions indicated that a classification had to be  done on the basis of the available information.  
This meant that additional testing could not be re quired.  Under REACH however, the EU authorities, 
could if necessary for the purposes of registration, ask for the additional testing.  In addition, industry 
could also ask to perform additional testing particular ly animal testing for the registration.  If this was 
the case, they were to make a proposal and ECHA would assess it and decide if such testing was 
needed or not.   
109. Regarding questions on what the European Un ion needed in order to re-evaluate the 
classification, she explained that the CLP regulation clearly indicated that the classification would be reviewed when new scientific evidence was provided.   Regarding Australia's request for information 
on the three nickel compounds that were supposed to be found on the market place with concentration 
levels above those which were authorized, to th e EU's knowledge, as indicated in the replies to 
notification G/TBT/N/EEC/297, there had been no products on the market which contained the 
classified nickel compounds in concentrations abov e the authorized levels.  She referred to the 
explanations her colleague had provided under the ag enda item 2(i) on the issue of the risk assessment 
on borates.  She reminded delegations, that if ther e was any information wh ich could challenge the G/TBT/M/51    
Page 26  
 
  Commission's conclusions on classifications and labelling, that industry could submit such 
information to the EU and ask that it be submitted to ECHA for revision. 
(vi) Canada – Compositional requirements fo r cheese (G/TBT/N/CAN/203 and Add.1)   
110. The representative from New Zealand
 reiterated concerns about  Canada's compositional 
standards for cheese and their consistency with the principles and obligations of the TBT Agreement. 
New Zealand's assessment of the standards was that th ey were overly restrictive, both in terms of the 
thresholds imposed for the use of dairy ingredients,  and their impact on trade.  The standards limited 
the use of protein sourced from dairy ingredients,  when such ingredients were widely used and 
accepted in cheese production worldwide.  He furthe r stressed that these compositional standards 
were inconsistent with the relevant Codex st andard, which did not prescribe limitations on the 
sourcing of milk proteins for use in cheese manufactu re.  The delegate request ed Canada to provide 
the TBT Committee with an update on developmen ts with the appeal process following the initial 
court ruling on the cheese standards and on whether the standards were being enforced pending the 
outcome of the appeal.  He also asked Canada to  confirm whether or not its dairy producers were 
actively lobbying the government to introduce similar standards for yoghurt, and if so what had been 
the government's response to this proposal  
111. The representatives of the European Union  and Australia  supported the concerns raised by 
New Zealand. 
112. The representative of Canada  explained that the revised regul ations clarified and harmonized 
the federal compositional standards for cheese. The revised regulations had come into force on 
14 December 2008 and applied to cheese manufactured after that date. She highlighted that when 
developing these regulations, Cana da had taken international st andards and other countries' 
regulations into account, as well as the comments received during the WTO's notification period.  She informed the Committee that all im ported cheeses were deemed to be in compliance with the revised 
standard. She added that the G overnment of Canada had not in itiated any regulatory process for 
establishing compositional standards for other dairy pr oducts. She noted that hearings of the Judicial 
Review had been held on 31 March and 1 April 2 009.  On 7 October 2009, the Federal Court had 
ruled that the application for judicial review made by  the applications be dismissed.  The federal court 
decision was currently being appealed by two of the applicants. She concluded that there was no 
evidence that the regulations constrained the existi ng overall usage of milk ingredients, such as milk 
protein concentrates. 
(vii) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33)   
113. The representative of the European Union
 reiterated concerns rega rding the Indian order 
laying down a registration procedure of importe d cosmetics products.  During a recent bilateral 
meeting, India had informed the European Union that  it had revised the draft.  She asked whether this 
draft differed from the previously notified version an d whether India intended to notify this new draft 
to other WTO Members. 
114. The representative of India  said that the draft of the new rules, aiming at protecting public 
health, had been notified in 2007.  He announced that the inputs received from the European Union 
and the United States would be taken into  account when finalizing these new rules. 
(viii) China – Proposed Regulations on Informa tion Security (G/TBT/N/CHN/278-290)   
115. The representative of the European Union  expressed his delegation's disappointment about the 
entry into force as of 1 May 2010 of the China Co mpulsory Certification scheme, the so-called CCC-I 
Scheme, for 13 categories of IT security products  pursuant to joint notice on implementation No.  G/TBT/M/51  
 Page 27 
 
 
  2010/48 of 28 April 2010 issued by the Minister of Finance, CNCA, AQSIQ and MIIT.  The 
European Union regretted that the Chinese author ities had not considered the suspension of the 
implementation of the CCC-I rules in order to allo w for further discussions with interested trading 
partners and foreign industry in or der to address the substantive concer ns raised.  As had previously 
been mentioned, the European Un ion remained concerned that th e entry into force of the CCC-I 
scheme, together with the continued application of the Office of State Commercial Cryptography 
Administration (OSCCA) 1999 Regulations on commerc ial encryption and the full implementation of 
the Multi Level Protection Scheme (MLPS) in the near  future would introduce significant restrictions 
on access to the Chinese market for a wide range of in formation security products, including products 
which had purely commercial application and as such were not sensitive for protecting national 
security.   
116. On the OSCCA regulation, China had indi cated at the November 2009 TBT Committee 
meeting that the regulation was being revised and that OSCCA would be open to an exchange of 
experiences with foreign governments.  The European Union had reconfirmed its interest to work with 
China on this issue with a view to ensuring a level playing field in China between domestic 
manufacturers of commercial encryption products and foreign invested companies producing the same 
products in China or foreign manufacturers, and al so with a view to aligning the OSCCA regulation 
with relevant international standards and practices.   The delegate of the European Union requested 
China to provide an update as to the current status of the revision of the 1999 OSCCA Regulations, as 
it was the European Union's understanding that the dr aft text was already with China's State Council 
Legislative Affairs Office . He also asked China wh ether it was possible to access the draft, whether 
interested parties could contribute to the revision process and when the TBT notification of this draft 
could be expected.  He stressed the importance of transparency in the revision process given the high 
stake for foreign industries and demanded an effectiv e participation of foreign stakeholders in this 
process.   
117. On the CCC-I scheme, the European Union welc omed the clarifications provided by China 
regarding the coverage, and in particular that st ate-owned enterprises would not be covered by the 
scheme. He asked to receive further clarification on whether semi-public entities, such as hospitals or 
schools which operated in non-security sensitive sectors , were also excluded from the scope of the 
CCC-I scheme. He also asked whether entities receiving public funding, for instance from the 
Ministry of Science and Technology for research and development purposes, would be excluded from 
the coverage or whether receiving this funding w ould mean that they would be covered by the 
definition of government procurement pursuant to the relevant law on government procurement in 
China. 
118. The representative of the European Union emph asized his delegation's fundamental concerns 
about the viability of the CCC-I Scheme with respect to its excessive disclosure requirements, which 
meant that companies would have to divulge sens itive design information, including the source code 
during the evaluation process.  This was compo unded by an overall lack of transparency and 
unpredictability of the system, in particular in re gard to those encryption products for which OSCCA 
would be required to carry out the evaluation of the source code, since procedures applied by OSCCA 
were not publicly available. He noted that OSCCA did not communicate in writing with foreign stakeholders and companies interested in submitting an  application file and thus the latter did not have 
access to the necessary information in  order to adequately prepare su ch applications.  The European 
Union also remained concerned about the potential de facto  application of the CCC-I scheme in the 
commercial area, whereby several state-owned ente rprises in the IT field were requiring compliance 
with the CCC-I scheme as a purchasing condition, which could potentially deprive foreign 
manufacturers from effectively accessing to the Chin ese market.  The European Union urged the 
Chinese government to confirm that this practice would neither be encouraged nor endorsed by 
Chinese authorities.   G/TBT/M/51    
Page 28  
 
  119. With respect to the Multi Level Protection Sc heme, the European Union remained concerned 
about the lack of clarity as to the way the concept of 'critical infrastructure' would be interpreted.  The 
European Union delegate recalled that, if the IT  system of a company was qualified as critical 
infrastructure, then only products having obtained CCC-I or OSCCA certification could be used in 
those systems. This opened a back door appli cation of the CCC via the Multi Level Protection 
Scheme. For this reason, the European Union request ed further clarification as to how the notion of 
critical infrastructure would be interpreted and in pa rticular whether according to such interpretation, 
state-owned enterprises which operated in non-security  sensitive sectors would not be classified as 
critical infrastructure.  
120. The representative of the European Union also asked for a general update on the 
implementation of the Multi Level Protection Sche me, and what the current target date of 
implementation was.  Finally, he u nderscored the European Union's inte rest in remaining engaged in a 
technical dialogue with China and announced an upcoming proposal for starting a technical dialogue. 
121.  The representative from Japan
 supported the views presented by the European Union. In their 
view, the proposed regulations on information security  put forward by China were not in conformity 
with international norms and approaches and Japan remained concerned with the possibility that these 
measures could negatively affect trade in informa tion security products.  Japan requested China to 
provide further information regarding schemes wh ich had already been implemented especially its 
measures related to the protection of intellectual pr operty.  Moreover, Japan hoped that China would 
exercise prudence in introducing additional  measures regarding information security. 
122. The representative of China  explained that China had received comments from all interested 
parties and given them full consideration.  She clarified that China had narrowed down the scope of 
application to government procurement and postp oned implementation.  The representative further 
noted that China had stated repeatedly that it was not appropriate to continue discussions in the TBT 
Committee on this issue.  Concerning the regulati on on commercial cryptography, she explained that 
the revision of the State Council's regulation on commer cial cryptography had been put into the State 
Council's 2010 schedule.  Finally, she stated that China would take the European Union's and other 
interested parties' comments and s uggestions into consideration.  
123. The representative of the European Union  asked China to explain in greater detail what 
opportunities existed to provide input into the legislative process at this stage. 
124. The representative of China  reiterated that the revision had been added to the 2010 legislation 
plan. She announced that the comments received from the European Union would be brought back to 
the capital; China would then evaluated what opportun ities would be given to the European Union and 
other trade partners to be involved in the revision process. 
125. The representative of the European Union  requested a statement from China that the draft 
revised text would be notified at the appropriate stage, as it was a technical regulation and hence the 
minimum transparency requirement had to be fulf illed. He also enquired about the possibilities to 
provide input when a legislative proposal was pending with the State Council Legislative Office. 
126. The representative of China  reiterated that the comments received from the European Union 
would be brought back to the relevant agencies. 
(ix) India – Mandatory Certification for Steel  Products (G/TBT/N/IND/32 and Add.1)  
127. The representative of the European Union  reiterated concerns about India's mandatory 
certification requirements for steel.  India had informed the TBT Committee in March 2010 that 
certain items had been deleted from the list of produc ts that would require certification. The delegate  G/TBT/M/51  
 Page 29 
 
 
  from the European Union enquired whether this dele tion was permanent or whether it was limited to a 
period of 6 months, as has been indicated by I ndian authorities to economic operators. She further 
asked whether one product, namely galvanized steel sheets, was still on the list and therefore subject 
to the certification requirements.  India had no t given any explanation why the widely accepted 
international standards in this area had not been cons idered as sufficient to ensure product safety.  In 
the absence of such justification,  the European Union urged India to refrain from requiring mandatory 
certification proving compliance with a national standard. 
128. The representative of Japan  echoed the concerns raised by the European Union and requested 
an update on this measure. 
129. The representative of India  explained that the process was on-going and that no decision had 
been taken yet about deleting specific products.  Sec ondly, he explained that the Bureau of Indian 
Standards (BIS) reviewed standards on a regular b asis and international standards were not normally 
benchmarked.  However, he noted that the end use of galvanized steel was mostly in the rural areas 
where public health and safety were an important i ssue, and thus justified a specific standard.  He 
added that in the standard setting process India did benchmark against international standards. 
(x) European Union – Seal products (G/TBT/N/ EEC/249 and Adds.1-2; G/TBT/N/EEC/325)  
130. The representative of Canada  noted that on 3 May 2010 the European Union had circulated a 
copy of the Draft Commission Regulation laying down detailed rules for the implementation of Regulation 1007/2009 on the trade in  seal products.  Canada had notified the European Union at that 
time that the five day period for comments left little scope for other Members to submit detailed 
comments on the proposed measure and for the Europ ean Union to fully take  those comments into 
account.  Canada had also notified the European Un ion that its notification of the Draft Commission 
Regulation was incomplete, since it did not provide any HS or CCCN numbers to indicate which tariff 
lines would be subject to the regulation.  Canada asked whether the European Union was currently in 
a position to inform Members of the product coverage of the regulation. 
131. The representative of Canada noted that while the European Union's regulation referred to 
seal products, the scope of the import ban appeared to  be much broader, encompassing all products of 
all species of pinnipeds.  That definition included products  derived from ivory, from species such as 
walrus.  While the international trade in some pi nniped ivory products was regulated by the CITES 
Convention, trade in those products had not been pr ohibited.  He underscored that these products were 
of great cultural and commercial importance to indigenous communities in Canada and elsewhere. 
Canada urged the European Union to reconsider  any action which imposed additional regulatory 
barriers to the trade of sculptures derived from pinni ped ivory.  Canada recalled that the European 
Union defended its adoption of the ban on seal produc ts by stating that the fundamental economic and 
social interests of indigenous communities would not  be adversely affected by its seal regulation. 
Furthermore, Canada requested that the European Union state its objective in banning the importation 
and trade of products derived from pinniped species other than seals.  
132. The representative from Canada drew Members' attention to the fact that the regulation by the 
European Union on seal products introduced a require ment for the application of an "ecosystem 
based-approach" for natural resources management plans.  She noted, however, that the regulation 
provided no guidance on how to determine whether a particular programme met that requirement. 
Furthermore the implementation rules provided lit tle certainty to certification bodies on how to 
proceed in order to attest that products met the certification requirements. Canada also reiterated its 
concerns that the requirements for the establishm ent of accreditation bodies - and the time it would 
take the European Union to recognise these bodies - would result in a complete ban on the importation of seal products as well as other pinniped products for a lengthy period of time. G/TBT/M/51    
Page 30  
 
  133. The representative of Norway
 recalled that Norway had made several statements to the TBT 
Committee regarding the notification by the European  Union of Regulation 1007/2009/EC on trade in 
seal products ("the Seal Regulation"), first notified in draft form in document G/TBT/N/EEC/249. Since the last TBT Committee meeting, the Euro pean Union had notified a draft "Implementing 
Regulation" laying down detailed ru les for the implementation of the trade restrictions in the Seal 
Regulation, contained in document G/TBT/N/EEC/325.   Norway appreciated the invitation to provide 
comments to the draft Regulation, which had been  submitted by Norway on 4 May 2010.  He noted, 
however, that none of Norway's comments had been  taken into account by the European Commission 
and that no changes had been made to the final pr oposal submitted to the Eu ropean Parliament.  He 
stressed that the rules remained ambiguous, unclear, and far more trade restrictive than the legitimate 
objective could justify.  He argued that the new rule s established a regime that unjustifiably restricted 
trade in one of Norway's natural resources, which w as harvested in a sustainable and ethical manner.  
In Norway's view the trade restrictions to be im plemented in the European Union on 20 August 2010, 
as set out in Regulation 1007/2009 and in its implem enting regulation, were inconsistent with the 
TBT Agreement as well as GATT 1994.   
134. The representative of the European Union
 recalled that during the previous TBT Committee 
meeting the European Union had indicated that it w as of the view that the adopted regulation did not 
fall within the scope of the TBT Agreement; the Eur opean Union therefore considered it inappropriate 
to discuss it within the framework of the TBT comm ittee.  She signalled, however, that the European 
Union was available to discuss this matter within the framework of the regular bilateral contacts. 
(xi) Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96 and Adds.1-3)   
135. The representative of the European Union  recalled that in the last TBT Committee meeting 
Colombia had informed the Committee that it was work ing on a revision of the legislation on flexible-
fuel vehicles.  In particular, Colombia explained that it had been considering a reduction of the per 
centage of ethanol in gasoline that vehicles had to be able to use.  The European Union requested 
Colombia to give an up-date of the situation.  
136. The representative of Colombia  reiterated his government's readiness to revise the regulation 
in order to achieve greater flexibilit y with the respect to the reduction of the percentage of ethanol in 
the fuel mixture, taking into account the experiences of other countries.  He explained that in March 
2010 the Colombian inter-sectoral Committee, which approved the management of fuel, had met and 
noted the importance of revising the standard and st rengthening the flex fuel regime with an incentive 
for the national production of automobiles.  He adde d that this plan was currently being studied by 
Colombia.  With respect to the national policy on this measure and the commitments assumed to deal 
with this matter, he informed the Committee that the Ministry of Mines and Energy had 
commissioned a consulting company to make a technical study of flex fuel in Colombia.  He announced that on 28 June 2010 the technical proposal of the consultant for the fuel distribution chain 
which was required for implementation and for the development of the programme would be 
submitted.  He stated that Colombia had a number  of international experiences in the production of 
biofuels, in flex fuels for the automotive industry and the use of a percentage of ethanol in fuel. 
(xii) France – Unique Requirements for Ride-on Lawn Mowers 
137. The representative of the United States
 reiterated his delegation's concerns with respect to the 
French Ministry of Agriculture's skirt requirement s for ride-on lawnmowers, as the measure had never 
been published as part of an official law or decree,  never been notified to the WTO, and had disrupted 
US ride-on lawnmower exports to France.  He explai ned that the United States had raised its concerns 
on this issue in previous meetings, including que stions about the technical basis for the skirt  G/TBT/M/51  
 Page 31 
 
 
  requirement, the deviation of this requirement  from other member States' requirements and 
international standards, and the lack of transparency. 
138. At the last meeting, the United States had noted that there had been ongoing discussions 
involving US and European industry, the Ministry of Agriculture, the Commission, and other stakeholders to try and resolve this issue, in cluding efforts to find appropriate language for the 
European Committee for Standardisation (CEN) ride -on lawnmower standard EN 836.  This meeting 
had contributed to the adoption of a revised CEN st andard, with a large majority of members of the 
technical committee voting in favour.  He was disa ppointed that France's standards body had then 
appealed this standard which would further de lay the publication of the revised standard. 
139. The representative of the United States noted th at, in the meantime, the French authorities 
appeared to have stepped up efforts to enforce th e skirt requirement, and US companies felt that they 
were being unfairly targeted by these efforts.  Recen tly, the French Ministry of Agriculture had called 
into question test results from an EU "Notified Bo dy" demonstrating full compliance with EN 836 of 
one US company's ride-on lawnmowers, even though such test results had been accepted by all other EU member States without any problems or challe nges.  The United States urged the European 
Commission to review this issue closely and interv ene as appropriate to help resolve it both for the 
benefit of trade in safe, high quality lawnmower products that met the essential requirements, and 
given the systemic implications of Fr ance's actions for the new approach. 
140. The representative of the European Union
 wished to provide some clarifications with regard 
to the ongoing process of revising the European ha rmonized standard and the parallel development of 
the ISO standard on safety of lawnmowers. In pa rticular, regarding the revision of the European 
harmonized standard 836 which concerned the sa fety of powered lawnmowers, the technical 
committee had decided not to cover the essential re quirement 1.3.7 of Annex 1 to the Machinery 
Directive dealing with the protection of bystan ders against the risk of contact with moving 
transmission parts in the current amendment pr ocess. As a consequence, the relevant safety 
requirement  in the current draft amendment only co vered aspects relating to the safety of the operator 
in the driver seat, not of bystanders.  The cu rrent procedure which had been launched by the 
Association Française de Normalisation  (AFNOR), the French national standardization body and 
member of the European Committee for Standardiza tion (CEN), was precisely addressing the fact that 
the current amendment failed to address the prot ection of bystanders. The European Commission 
could not intervene in this process, as it was governed by CEN procedures.  The European 
Commission only reacted if and when the amende d standard was submitted to the European 
Commission with a request for publication of its refe rences in the Official Journal of the European 
Union with a view to giving presumption of conformi ty against the relevant essential requirements of 
the Machinery Directive.  It was only at that stage that the European Commission would take a 
decision on the publication based on the adequacy of  the proposed amendment against the objective of 
providing presumption of conformity.   
141. The representative of the European Union furt her explained that there was another parallel 
initiative in ISO aiming at developing an international standard of the safety of lawnmowers as part of 
the ISO 5395 series of standards.  This process was taking place under CEN lead according to the 
Vienna Agreement between CEN and ISO. The Eu ropean Commission encouraged all interested 
parties to seek an acceptable compromise solution to  the outstanding issues regarding the protection 
of bystanders in the framework of the development of this new international standard which was at 
the moment in draft stage and which was referenced as ISO/DIS/5395.   
142. Concerning the recent new market surveillan ce action undertaken by the Ministry of 
Agriculture in France, the European Commission did not intervene in this process.  Market 
surveillance was a prerogative of the national enforc ement authorities.  If a final measure restricting 
the placing on the market of the product in ques tion would be taken, then  the measure would be G/TBT/M/51    
Page 32  
 
  notified to the European Commission pursuant to the safeguard clause procedure of the Machinery 
Directive and at that moment, the European Co mmission would have to take a decision on the 
justification of the measure.  The European Union was willing to provide any further clarification on a bilateral basis.  He recalled that the interpre tation of essential requirement 1.3.7 by the French 
authorities had been endorsed by all other EU memb er States and the Eur opean Commission in the 
Machinery Working Group which was the technical body supporting the implementation of the 
Machinery Directive. This interpretation was thus  shared and supported by all other EU Member 
States. Current discussions had therefore now to focu s on what technical solution would give the best 
expression to that requirement, taking the state-of-the-art into account. 
(xiii) Korea – Regulation for Food Industry Prom otion Act (G/TBT/N/KOR/204 and Suppl.1)  
143. The representative of Canada
 thanked Korea for postponing the implementation date of the 
proposed amendments to the Food industry promotion act and Regulations to Ja nuary 2011. As set out 
in the TBT Agreement as well as in Codex, Canada  hoped that Korea would use the delay to include 
provisions into their regime which allowed for e quivalency agreements.  Ca nada would welcome the 
opportunity to work towards developing an equivale ncy arrangement with Korea. She explained that 
Canada was concerned that producers would be unable  to ship multi-ingredient products starting in 
2011 because they required additional time to ensure that all ingredients were certified to the Korean 
regime.  A further transition period for ingredie nt certification would be helpful, increasing the 
likelihood that Korean consumers would continue to  have access to a broad range of organic products 
in the coming years.  Canada was concerned that  the proposed amendments, which were more trade 
restrictive than necessary, would prevent Canadian  producers from supplying Korean consumers with 
organic products after 1 January 2011. 
144. In addition, Canada drew the Committee's attention to a multi-country letter from the 
Governments of Canada, the United States, the Europ ean Union, New Zealand, Australia and Chile to 
the Korean deputy Minister for trade policy, Ministry  of Food, Agriculture and Forestry and Fisheries 
(MIFAFF) which highlighted the shared concerns of all signatories over the proposed changes to the 
regulations.  Canada expected fu rther bilateral discussion with Ko rea outside the TBT Committee on 
this issue. 
145. The representative of the European Union  joined the delegation of Canada in reiterating its 
concerns regarding Korea's Regulation for the Fo od Industry Promotion Act.  The European Union 
appreciated Korea's postponement of the requireme nts by one year until 1 January 2011, as well as 
Korea's announcement in the March 2010 TBT Committ ee meeting that it was undertaking a study on 
the possibility to introduce an equivalence mechanis m in its organic regulatory system, in line with 
the CODEX guidelines on organic products.  In this regard, the European Union asked for an update 
from Korea about the state of play of the foreseen  amendment of its legislation to provide for 
recognition of equivalence of other countries' organic systems.  
146. Furthermore, she noted that notwithstanding the positive steps undertaken by Korea to 
facilitate the accreditation process, the approval pr ocedure for foreign certification bodies remained 
challenging. Of significant concern was the require ment to individually certify each ingredient of 
processed organic products, as well as the corresponding processing methods.  As stated in the past, the European Union judged that this requirement wa s nearly impossible to comply with, particularly 
in the case of processed products consisting of multiple ingredients, and would pose serious 
challenges for the importation of all but the most  basic multi-ingredient imported organic products 
into Korea.  The European Union therefore reite rated its demand to Korea to grant derogation from 
the requirement to certify ingredients in case of  imported products, at least until equivalence 
recognition was introduced. Finally, in order to allow for minimum distortions of trade of organic products in Korea, the European Union asked Kor ea to further extend the transitional period after 
which the existing system would be phased out.  G/TBT/M/51  
 Page 33 
 
 
  147. As a cosignatory of the joint letter recently sent to Korea's MIFAFF, the representative of 
New Zealand  supported the comments made by Canada and the European Union. New Zealand 
welcomed the announcement that a professor at Inha  University had been commissioned to undertake 
a review of Korea's proposed organic regulatory syst em.  This review process and the extension of the 
implementation date provided New Ze aland with the opportunity to work constructively with Korea 
on provisions in its regime that would allow fo r equivalence arrangements or other relevant 
arrangements for both processed organic products and raw organic produce.  New Zealand was 
hoping for changes that would ensure minimal disrup tion to the market place and would ensure that 
Korean consumers would continue to have access to  a broad range of organic products in the coming 
years helping Korea meet the objectives of its food industry promotion act. 
148. The representative of Switzerland  recalled that at the last TBT Committee meeting, Korea has 
stated that the MIFAFF was conducting studies on how to  install a system to implement measures that 
was based on equivalency.  Switzerland requested  Korea to inform the TBT Committee about the 
outcome of these studies and to extend the transiti onal period until the installation of such a system. 
149. The representative of Australia  shared the concerns raised and confirmed that Australia was 
one of the co-signatories to the joint letter.  Aust ralia welcomed the decision by Korea to allow the 
revised regulations governing the import of organic food products into Korea to run in parallel with 
the Korean Food and Drug Administration labellin g requirements until 31 December 2010.  In 
addition, Australia asked for an update on concerns that Australia had previously raised regarding the 
revised regulations, for example: education require ments and auditor numbers. Australia's concerns 
had been addressed through minor amendments and were supposed to be announced in March 2010. 
However, as of June 2010, the Australian competiti on authority for organic exports had not received 
confirmation of these amendments.  Furthermor e, as advocated in the June 2009 equivalency 
recognition request, Australia considered that its organic export system met the policy intent of 
Korea's new requirements.  Australia was aware of the fact that before equivalence recognition of foreign government systems were to be permitted, legislative cha nges to both the Food Industry 
Promotion Act and the Environment-Friendly Prom otion Act were required.  In line with the 
principles for equivalence agreements as set out in  the TBT Agreement, as well as in Codex, Australia 
encouraged Korea to delay mandating the revised  regulations until such a time when provisions 
allowing equivalence recognition were in place. 
150. The representative of the United States
 welcomed Korea's decision to extend the 
implementation date of its processed organic products regulation for one year in order to allow trade 
to continue to flow.  However, the United Sat es remained concerned that the regulation did not 
currently contain a procedure for recognition or equi valence.  The United States encouraged Korea to 
work as quickly as possible to amend the regula tion to incorporate language allowing for such 
agreements.  The United States also welcomed an update on the status of that process and the study 
that was being conducted. 
151. In addition, the representative of the United Stat es raised concern over the difficulty that US 
producers faced in meeting the revised requirements.   A particular concern was the requirement for 
individual certification of ingredients in processed products.  The United States was concerned that 
many producers would be unable to ship multi-ingred ient products starting in  January 2011 because 
the requirement to individually certify each ingredie nt in processed products would make certification 
of all but the simplest multi-ingredient organi c products extremely challenging, which could be 
detrimental to exporters, importers, domestic processo rs, retailers, and Korean consumers. To remedy 
this situation, the United States proposed a further transition period for ingredient certification until 
such point as a recognition or equivalence arrangeme nt was established between the interested parties 
and Korea.   G/TBT/M/51    
Page 34  
 
  152. The representative of Korea
 recalled that during the last TBT Committee meeting, Korea had 
informed Members that the MIFAFF was conducting a f easibility study on the topic of equivalency.  
He noted that the MIFAFF was in the course of unifying the two certification systems for processed organic foods and organic foods.  Furthermore, he informed the TBT Committee that the MIFAFF 
was conducting a feasibility study on the issue.  He st ated that it would be impossible for Korea to 
grant an additional implementation extension as the MIFAFF had already postponed its 
implementation date twice.  All other comme nts raised would be delivered to MIFAFF. 
(xiv) Brazil – Health products reg istration (G/TBT/N/BRA/328)  
153. The representative of the United States
 welcomed the step taken by Brazil to ensure that trade 
in safe, high quality medical devices was not disr upted since the 22 May 2010 implementation date 
for Resolution 25 and to provide additional details to  industry on the inspection process. He noted that 
the US industry had informed the US government that Brazil had not prevented any of its products from being marketed in Brazil due to a failure to have a facility inspection in connection with re-
registration of those products already on the ma rket.  However, during the ANVISA-industry meeting 
earlier in June 2010, Brazilian regulators had told companies that they should have applied for 
inspections six months in advance of the 22 May 2010 implementation date. He emphasized that 
ANVISA had not yet issued its clarifying guidance and answered the follow-up questions in sufficient 
time for the medical device industry to submit its appli cations by this deadline. Further, since industry 
had not been aware that they should have app lied for inspection six months in advance, some 
companies had not done so for certain products and were concerned that Brazil might prevent the 
marketing of those products in Brazil. Given the in itial lack of clarity on the requirements and time 
frames, the United States requested that Brazil cl arify whether approved devices could continue to 
remain on the market pending a GMP inspection.  
154. The representative of the European Union
 joined the United States in raising concerns with 
regard to Brazil's requirements for registration of  medical devices.  The European Union had just 
received Brazil's latest reply to the EU comments on notification G/TBT/N/BRA/328, focusing in 
particular on Brazil's non-acceptance of ISO 13485 certification. She announced that the European 
Union would analyze Brazil's reply in detail and w ould get back to Brazil bilaterally with further 
queries.  In the meantime, and notwithstanding EU's request on acceptance of ISO certificates, the European Union asked Brazil to provide an update on the ongoing implementation of the good manufacturing practices (GMP) requirements.  In particular, the European Union asked for information on the number of facilities for whic h ANVISA had completed audits and issued GMP 
certificates as well as those for which audits had been  requested, but not yet completed.  According to 
information available to the European Union, it app eared that not all manufacturing sites for which an 
audit request had been submitted had been audited by ANVISA by the 22 May deadline.  In order to 
prevent possible market access disruptions and conf usion of economic operators, the European Union 
asked Brazil to provide assurances that medical devi ces for which an audit request had been submitted 
to ANVISA continued to be placed on the Brazilian market pending the relevant GMP audits, even 
though their registration had expired.  
155. The representative of Switzerland
 echoed the concerns raised  by the European Union. 
Switzerland remained concerned about the change in  Brazil's legislation regarding market access for 
medical devices classified in Brazil under risk 3 an d 4.  As had been mentioned, for these medical 
devices, Brazil no longer recognized quality inspection results based on the international standard ISO 
13485.  He recalled that this ISO standard w as the main international standard for quality 
management systems for medical devices.  Quality in spection results based on this ISO standard were 
accepted in Switzerland and were accepted in Brazil in  the past.  Switzerland was surprised that Brazil 
no longer accepted this ISO certification.  This was even more surprising as in the context of the 
NAMA NTB negotiations, Brazil was a cosponsor  of a framework unde rstanding on non-tariff 
barriers (TN/MA/W/136).  In this document ISO was recognized as a relevant international standard  G/TBT/M/51  
 Page 35 
 
 
  setting body.  Switzerland asked Brazil to explain why ISO 13485 was considered inappropriate to 
assure risk control and quality of medical devices classified in Brazil under risk 3 and 4. 
156. The representative of Brazil  recalled that ANVISA resolution no. 25/09 aimed at guaranteeing 
the quality of medical devices sold in Brazil and, co nsequently, protecting huma n health.  This was a 
legitimate objective explicitly recognized by the TBT Agreement.  He emphasized that Brazil had no 
intention of disrupting the entry of imported medical devices in Brazil due to the essential nature of 
those goods and due to the interna tional obligations of the country.  He informed the TBT Committee 
that the sanitary authorities of Brazil had not r eceived any complaint of  troubles related to the 
importation or commercialization of medical devices in Brazil.  The representative further stressed that ANVISA resolution no. 25/09 had done nothing more than establish deadlines for companies to 
comply with requirements already laid down in ANVI SA resolution no. 59, published in 2000.  These 
requirements were already mandatory for domestic manufacturers, so there was no room for allegations of discrimination or surprise w ith the content of resolution no. 25/09. 
157. He reported that the inspections necessar y for the granting of certificates of good 
manufacturing practices were being carried out  in a timely and orderly manner by ANVISA 
employees, thus allowing the regular flow of me dical devices to Brazil.  ANVISA had conducted 144 
inspections so far, and 77 were already scheduled .  There were 180 requests waiting to be scheduled, 
depending mostly on the definition of dates convenient both the ANVISA and companies. 
158. Regarding questions about the imposition of  requirements going beyond ISO 13485, he 
clarified that the international standard and the requirements of RDC no. 59/ 00 had different scopes, 
although they were not conflicting.  ISO 13485 focused on the characteristics of the manufacturing 
company quality system, whereas RDC no. 59/00 dealt directly with production processes and 
methods and its main focus was the risk of the medical devices classified under high risk classifications (Risks 3 and 4). 
159. With regard to the question from Switzerland on the compatibility of the Brazilian regulation 
with the proposal made by Brazil on the NTB negotiating group (NAMA), he stated that although the 
proposal sought to recognize some international standard setting bodies as relevant, the proposal did 
not derogate from what the TBT Agreement had estab lished, i.e. that a country might deviate from an 
international standard to protect legitimate public  policy objectives, which was the satiation in this 
case.  
160. He further pointed out that the imposition of th e certification requirements additional to ISO 
13485 was common international practice.  In fact, the requirements set by RDC 59/00 were based on 
the requirements imposed by the United States in Part 820 of the Quality System Regulation 
contained in the Code of Federa l Regulation - Food and Drugs. As for the European Union, Directive 
93/42 established combinatory models of conformity assessment procedures which combined ISO 13485 with other methods, such as clinical tria ls, project evaluation and type approval.   
161. He emphasized that, so far, Brazil was not aware of any concrete case of problems with this 
resolution.  It was very important that compani es that wanted to register a new medical device 
classified under Risks 3 and 4 or whose existing re gistration was about to expire applied for the 
certification within a reasonable time in advance.  He recommended a period of six months in advance 
and clarified that that in case the existence of GM P expired, it would remain valid until the inspection 
necessary for the renewal if it was requested by the company at least 120 days before the expiry date 
of certification and that was according to resolution 66 of ANVISA of October 2007. 
162. The representative of the United States
 clarified that the US Food and Drug Administration 
did not require re-registration for approved products to remain on the US market. G/TBT/M/51    
Page 36  
 
  (xv) European Union – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152)  
163. The representative of Korea  informed the TBT Committee that following a discussion with 
the European Union earlier that day, Korea had rece ived answers to their queries.  The concern that 
Korea had raised was that national authorities of EU member States might refuse attestations of 
conformity issued under accreditation by non-Eur opean accreditation bodies not complying with the 
new EU requirements, but which were signatories to IAF and ILAC MLA/MRA.  He asked whether 
only a government-to-government MRA with the Europ ean Union or a sub-contract agreement with 
an EU notified body would be a way that non-Eur opean ILAC and IAF signatories could be accepted 
by EU member States.  If this was the case, he requ ested the European Union to explain the value of 
the ILAC MRA and/or IAF MLA in the European Uni on after the regulation had entered into force on 
1 January 2010.  
164. The representative of the United States  reiterated serious concerns  regarding the European 
Union's new accreditation framework set forth in Re gulation 765.  He explained that the measure 
applied to all sectors, required each EU member St ate to appoint a single national accreditation body 
that operated as a public, not-for-profit entity, and prohibited competition among member States' 
national accreditation bodies within each member State.   This meant that only a single, government 
entity in each member State was permitted to accr edit conformity assessment bodies in the European 
Union.  
165. However, the United States continued to be especially concerned with the Regulation's 
potential impact on the recognition of non-EU accr editation bodies under the ILAC MRA and the IAF 
MLA, and the acceptance of conformity assessments performed by ILAC MRA and IAF MLA 
accredited bodies.  Thus far, with respect to ILAC , EA ILAC signatories appeared to be cooperating 
with non-EU ILAC signatories, confirming the equi valence of their accreditations; given that both 
sets of bodies (i) maintain conformance with IS O 17011 and related ILAC guidance documents; (ii) 
ensured that all of their accredited laborator ies complied with ISO 17025 and related ILAC 
documents; and (iii) had been peer reviewed and shown to meet ILAC's criteria for competence  
166. The United States noted that the regulation left to member States the decision of whether to 
recognize non-European accreditation bodies, as we ll as the decision as to whether or not accept 
conformity assessments issued by ILAC and IAF accredited bodies.  The United States was concerned 
that without clear guidance from the European Commission, EU member States might refuse to 
recognize non-European accreditation bodies and conformity assessments issued by non-European 
testing and certification bodies; this would unde rmine the international accreditation system and 
impede US exports to the European Union.  
167. He noted that the European Co-operation for Accreditation (EA) continued to promote EA 
I/13, which announced that EA would sign a Coope ration Agreements with accreditation bodies from 
other countries only if such bodies met the requirements of Regulation 765.  The EA had indicated 
that it would take steps to terminate existing coop eration agreements that were not based on those 
requirements.  Moreover, not only did the EU accreditation bodies appear to recognize the 
equivalence of their accreditations with non- EU bodies that were ILAC MRA and IAF MLA 
signatories, but the Commission had recognized many times that attestations of conformity issued 
under accreditation by non-EU accreditation bodies c ould be considered equally reliable as those 
issued under the accreditation of an EA MLA signatory.   
168. At the last TBT Committee meeting, the Europ ean Commission had also noted that there had 
been no scientific and technical basis for the Regulation 765 requirements noting that they had been mandated by a political decision.  Thus, for the Un ited States, there appeared to be no basis under 
which an EU accreditation body could consider atte stations of conformity issued under accreditation  G/TBT/M/51  
 Page 37 
 
 
  by non-EU accreditation bodies that were signatories  to these two arrangements and did not meet the 
Regulation 765 requirements as detrimental to the cr edibility of the accreditation.  The representative 
noted that under Regulation 765, each EU member  State accreditation body appeared to have a 
monopoly in its own market, yet the member State accreditation bodies could compete with each other in other countries' markets.  In the view of  the United States this provided additional evidence 
that the European Union did not have concerns w ith the reliability of accreditations in the presence of 
competition between accreditation bodies. If it did,  the requirements would limit competition between 
European Union member States' accreditation bodies in overseas markets as well.  He concluded that 
if the European Commission continued to leave this matter entirely up to the EA and the individual 
European national authorities, the status of non- EU accreditors in the European market would be 
thrown into doubt, which could have a detrimen tal impact on the international accreditation 
framework.  It would also represent a significan t step back for the acceptance of conformity 
assessment results more generally.  The United St ates therefore urged the European Commission to 
provide guidance to the EA and the individual European national authorities. 
169. The representative of Australia
 shared the concerns raised by other delegations that 
Regulation 765/2008 co uld potentially impede the recognition of conformity assessment procedures 
accredited by third party accreditation bodies.  She noted that Regulation 765 required the national 
accreditation bodies of European Union member Stat es to assume full legal responsibility for the 
results of conformity assessment procedures endor sed by foreign accreditation bodies, even though 
these foreign accreditation bodies might not fully satisfy some of the criteria established in Regulation 765.  While Australia recognised that the EA ha d adopted a resolution that foreign accreditation 
bodies which were signatories to the IAF/ILAC, but did not necessarily meet the internal criteria of 
Regulation 765, were "equally reliable from a technical  point of view", Australia remained concerned 
over the potential for European Union national acc reditation bodies to refuse to recognise foreign 
accreditation bodies.  Australia invited the European Union to further clarify the operation of Regulation 765, and its interacti on with foreign accreditation bodies. 
170. The representative of Thailand
 supported concerns raised by the previous Members.   
171. The representative of the European Union  first referred to the comprehensive explanation of 
the new accreditation system in the European Union th at had been given by the European Union at the 
previous TBT Committee meeting. He highlighted that the new accreditation framework did not change anything regarding the ability of non-EU c onformity assessment bodies to perform conformity 
assessment in the regulated area. A conformity  assessment body not established in the European 
Union territory could not as such qualify for Notified Body status under EU regulations, irrespective 
of whether it was accredited or not. He recalle d that during the last TBT Committee meeting the 
European Union had explained the rationale for estab lishment being an eligibility criterion for notified 
bodies, and that the EU system involved the use of Supplier's Declaration of Conformity (SDoc) in vast sectors of the economy thanks to the application of regulatory impact assessment (RIAs) tools in 
the conformity assessment area. Therefore, as prev iously mentioned, the sectors of the economy in 
which the EU required mandatory th ird party conformity assessment were fairly narrow; - however, in 
these sectors, the performance of the conform ity assessment required unde r EU regulations was 
reserved for the notified bodies.   
172. The representative of the European  Union also stated that the system provided for significant 
flexibility in the sense that substantial parts of the conformity assessment procedure, such as the 
testing or any inspection that might be require d under any quality management system assessment, 
could be subcontracted by a Notified Body to a conformity assessment body outside the European 
Union.  In these cases, accreditation from Members of ILAC or IAF would generally be presumed to 
establish the technical competence requirements in order to qualify for entering into subcontracting arrangements with an EU Notified Body.  He clarified that the only task that could not be 
subcontracted was the actual issuing of the cer tificates because, for reasons related to the G/TBT/M/51    
Page 38  
 
  accountability of the system, only a body which ha d been designated as a Notified Body could 
undertake this responsibility. He also  clarified that the designation of a Notified Body involved a two 
stage process: firstly, a technical assessment, which typically was based on accreditation, and secondly a political decision whereby EU member States took responsibility for the operation, supervision and monitoring of this body; this was because, as stated previously, this body would go 
onto perform third party conformity assessment in th e public interest. For these reasons the European 
Union was of the view that the system could only operate as intended if those bodies were coming fully under the jurisdiction of European Union member States.  
173. On the interface between the EU accreditation system and the international system under 
ILAC or IAF, the representative referred to the do cument (EA 1-13:2009, Ma y 2009) that had been 
quoted by the United States and which set out the cu rrent policy of EA as regards its relationship with 
accreditation bodies in countries which were not me mbers of the European Union or EFTA.  He 
confirmed that the system which was envisaged by this policy document basically foresaw two 
different frameworks, by dividing accreditation outs ide the European Union into two categories.  
First, there were accreditation bodies from countries which were either candidate for accession to the 
European Union or belonged to the so-called Eur opean neighbourhood; these were already integrated 
in the internal market or were (or would be) linked to it in specific sectors through specific 
agreements, for instance Agreements on Confor mity Assessment and Acceptance of industrial 
products (ACAAs).  This implied that these count ries would be treated effectively as EU Member 
States for EU internal market purposes, which was only possible if they fully took over the EU body 
of legislation including the underlying quality infrastru cture, which comprised full integration in the 
EU's accreditation system in the relevant sector s. Therefore, cooperation between the EA and 
accreditation bodies of these countries had a particular  nature, due to the necessity for these countries 
to share the same obligations as EU Member States,  thus giving effect to the political objective of 
economic integration between the EU and the thir d countries concerned. Second, as for accreditation 
bodies outside the European neighbourhood, he expl ained that the policy document EA 1/13 2009 
stated clearly that the relations hip with those accreditation bodies w ould be managed through ILAC or 
IAF.  He stressed that that there was no intent ion to undermine in any way the operation of the 
existing international accreditation system.  Las tly, the EU would consider, also based on the 
discussions in the TBT Committee, whether furthe r written clarification regarding how EA would 
cooperate with non-EU accreditation bodies would be useful. The EU would in any event remain 
available for further bilateral discussions at expert level with interested delegations. 
(xvi) European Union – Poultry Meat (G/TBT/N/EEC/267 and Add.1)   
174. The representative of Brazil
 thanked the European Union for the information provided during 
bilateral discussions on the EU regulation 1047/ 2009 notified under G/TBT/N/EEC/267 and restated 
some concerns on the issue. He noted that the ne w EU regulation entered into force in May 2010, 
without taking into account any of the concerns or suggestions raised by Brazil. He reiterated Brazil's 
concerns that the EU regulation contained defi nitions for fresh poultry meat and poultry meat 
preparations that could lead to serious market access restrictions for foreign producers located far 
from the European Union market.  He explained th at the new rules could prevent the use of frozen 
poultry meat in frozen meat preparations without r easonable justification.  According to information 
provided by the European Union, the new rules would continue to permit that frozen poultry meat be used in poultry meat preparations provided that so me temperature limits were respected in the process 
of elaborating preparations.  The representative welc omed this clarification, but announced that Brazil 
would come back to this issue in the future de pending on Brazil's assessment of the feasibility of 
elaborating preparations within  those temperature limits.   
175. He explained that the European Union had al so informed the Committ ee that preparations 
made from frozen poultry meat would have to be  sold frozen, because selling meat defrosted or 
chilled could mislead consumers which could believe  those products were fresh.  Brazil therefore  G/TBT/M/51  
 Page 39 
 
 
  restated its suggestion that using the phrase "pre viously frozen" in defrosted poultry meat and in 
preparations made with frozen poultry meat which were sold as frosted or chilled.   
176. He noted that in bilateral discussions, the Eur opean Union had stated that consumers could 
erroneously buy defrosted poultry meat as fresh and re freeze it afterwards. He further elaborated that 
the European Union had also argued that labels such  as the ones suggested by Brazil were ineffective.  
However, Brazil considered Eur opean consumers to be capable of understanding the differences 
between frozen, fresh and defrosted poultry meat , and asked whether the European Union had any 
empirical evidence to show that labels such as the ones suggested by Brazil did not work.  Brazil held 
the view that the acceptance of the Brazilian suggestion would make the regulation less trade restrictive. Despite the informati on provided by the European Union, Brazil still believed that the new 
regulation created de facto  discrimination in favour of European producers, thus violating Article 2.1 
of the TBT Agreement.  Because of transportation distances, only European producers would be able 
to sell poultry meat which was not frozen in th e European market.  Additionally, only European 
producers would be able to provide poultry meat for the fabrication of fresh preparations.  Finally, 
Brazil requested the European Union to consider its alternative labelling suggestions.  He further 
informed the TBT Committee that Brazilian authoriti es and private sector continued to examine the 
compatibility between Regulation 1047/2009  and the relevant WTO Agreements. 
177. The representative of Australia
 remained interested in Brazil's concerns.  
178. The representative of the European Union  informed the Committee th at the bilateral meeting 
held earlier that day had clarified a number of issu es.  At the last TBT Committee meeting, Brazil had 
stated that the EU measures would have the practic al effect of prohibiting the use of frozen poultry 
meat in poultry meat preparations, and had stated that, in their view, there was no sanitary or hygienic 
impediment to using frozen poultry meat in poultry m eat preparations.  She stressed, however, that the 
new marking rules on fresh poultry preparations did not in any way prohibit this use and that there was no impediment in the European Union of us ing frozen poultry meat to make a poultry meat 
preparation.  She therefore considered that Brazil's understanding of the European Union rules was 
not correct. 
179. For the purpose of clarification, she explained that frozen poultry meat could continue to be 
used in poultry meat preparations a nd such preparations were to be so ld at retail level in a frozen state 
at a temperature not higher than minus 18°C at any time.  According to EC Regulation No 853/2004 
meat preparations must be frozen to an internal temperature of not more than minus 18°C and this temperature had to be maintained during storage and transport. In this regard, it was important to note 
that partial rise of temperature was possible in  accordance with procedures based on the Hazard 
Analysis Critical Control Point Process in which certain toleran ce might be permitted for a minimum 
period of time necessary for the manufacture.  Ther efore, the temperature of frozen poultry meat 
could be raised to produce a preparation and then be lowered again for sale. 
180. She recalled that at the last meeting, the Br azilian representative had stated that Brazil had 
suggested that poultry meat preparations made fro m frozen poultry meat be marketed as "previously 
frozen".  She explained that this option had, howev er, not been retained by the EU authorities as it 
would mislead consumers in the sense that they would be buying prepara tions which were fresh 
looking, but which in fact had been prepared with frozen poultry meat.  On the allegation made by Brazil that the EU rules could be de facto  discriminatory as foreign producers had to freeze poultry 
meat in order to export it to the European Union,  she replied that a considerable number of poultry 
meat and poultry meat preparations which were produced domestically were transported in frozen 
state within the European Union. Finally, she noted  that after a thorough analysis of the Brazilian 
comments, the European Commission had concluded that there should not be a substantial impact 
since the vast majority of the EU imports from Brazil which were at stake were either poultry 
products or preparations, for which the marketing standards did not introduce any new requirements. G/TBT/M/51    
Page 40  
 
  (xvii)  Canada – Bill C-32 amendment to Tobacco Act    
181. The representative of the European Union
 reiterated concerns a bout Canada's Bill C-32 
amending the Tobacco Act, and requested Canada to provide replies to several questions raised by 
Members at the March 2010 TBT Committee meeting.  In particular, the European Union urged 
Canada to provide some backgroun d with regards to its approach to ban a comprehensive list of 
additives, including certain flavours which might be perceived as appealing to youngsters. Further, the 
representative of the European Union asked whether Canada could make available scientific studies or 
other relevant information that established a link between the prohibited additives and attractiveness 
to youngsters. She also requested that Canada provide assurance to the TBT Committee that the 
measures envisaged achieved uniform levels of prot ection in relation to all forms of tobacco, no 
matter whether imported or domestically produced. Fina lly, she asked Canada for further detail about 
any other policy initiatives that it had introduced, or was planning to introduce, in conjunction with 
Bill C-32 in order to deter smoking among youngsters  and increase awareness of tobacco-related risks 
in this particular population group. Lastly, she noted that the European Union strongly supported 
Canada's objective of protecting human health and,  in particular, deterring youngsters from smoking, 
which was in line with the WHO Framew ork Convention on Tobacco Control.  
182. The representative of Indonesia  (G/TBT/W/332) responded to the communication to the TBT 
Committee by Malawi dated 23 March 2010, on the effects of Canada's Cracking Down on Tobacco 
Marketing Aimed at Youth Act  on Malawi's exports of burley tobacco (G/TBT/W/329).  In this 
communication Malawi had expressed concerns that Canada's law was inconsistent with Canada's 
obligations under the WTO TBT Agreement.  In  particular, Malawi was concerned about the 
consistency of the law's prohibition on the manufactur e and sale of cigarettes, little cigars, and blunt 
wraps containing certain flavourings and additives e numerated in a Schedule to the law with Articles 
of 2.2 and 2.8 of the TBT Agreement.  In its co mments, Malawi compared the approach Canada had 
taken to reduce youth smoking in its law to similar laws of other countries, such as France, Australia, 
and the United States.  Malawi implied that the regulatory approach taken by these other countries, 
which banned only products with characterizing confectionary or fruit flavours, was less trade-
restrictive than Canada's law and therefore so mehow consistent with the TBT Agreement.  
183. In addition, the representative of  Indonesia objected to any sugg estion by Malawi or any other 
WTO Member that the manner in which the United St ates had restricted certain flavoured cigarettes 
was consistent with GATT 1994, the TBT Agreemen t or other WTO agreements.  Indonesia noted 
that it had requested that the Dispute Settlement Bo dy establish a panel to hear its dispute with the 
United States regarding a measure in the Fam ily Smoking Prevention Tobacco Control Act of 2009  
that banned the production and sale of clove cigare ttes, but allowed the sale of other cigarettes, 
including menthol cigarettes (WT/DS406/2).  He clarified that Indonesia did not disagree with Malawi that reducing youth smoking was a legitimate  health objective, or that limiting a ban to 
"characterizing flavours" was a more precise appr oach to discourage youth smoking than limiting all 
flavourings and additives.  However, Indonesia argued  that an even more targeted ban must be non-
discriminatory, based on scientific and technical evidence, and at a minimum, cover those characterizing flavours shown to attract youth smokers.  Indonesia maintained that the ban on the sale of clove cigarettes in the United States was inco nsistent with various US obligations under the 
relevant WTO rules and principles, and should not be  viewed as a "model" for regulations in other 
countries intended to restrict the production and sal e of flavoured cigarettes arguably designed to 
attract youth.   
184. The representative of Mexico
 expressed his disappointment about the answer by Canada at 
the last TBT Committee meeting on its intention not to notify the law C32 from the parliament.  For 
Mexico, it constituted a dangerous precedent, wh ich cast doubts on the seriousness with which 
Canada assumed its international commitments.  Me xico was still awaiting a specific response to the 
questions put at the last TBT Committee and desc ribed in paragraph 185 in G/TBT/M/50.  Mexico  G/TBT/M/51  
 Page 41 
 
 
  supported the objective of protecting human health, however it questioned the way in which this 
objective was being approached in Canada and in particular the lack of transparency. 
185.  The representative of Kenya  (G/TBT/W/330) shared the concerns and questions raised by 
other Members.  He noted that the proposed Canadi an law, if implemented in its current form, would 
effectively ban traditional blended cigarettes which were one of the two majo r brands of cigarettes 
widely traded in the world and Kenya's key concern w ith this legislation.  He explained that it was a 
well known fact that traditional tobacco was normally produced with three types of tobacco, namely Virginia, Burley and Oriental and further blended with additives that the proposed Canadian law was 
seeking to prohibit. Banning these a dditives would effectively ban trad itional blended cigarettes, even 
though in Kenya's view, such cigarettes did not e xhibit any discernible confectionery, fruit or other 
flavour perceived to be attractive to the youth.  The amendment was therefore contrary to the 
provisions of Article 12.3 of the TBT Agreement which entailed that WTO Members should ensure 
that their technical regulations did not creat e unnecessary obstacles to exports from developing 
country Members. 
186. Furthermore, Kenya held the view that the pr oposed legislation was in consistent with other 
provisions of the TBT Agreement namely Articles 2. 2, 2.8, 2.9 and 12.3.  Although the proposed law 
was intended to address a specific concern, it was unnecessarily trade restrictive.  In the opinion of 
Kenya the issues in the legislation could easily be re solved through other equa lly effective means that 
were less trade restrictive and consistent with Ca nada's obligations under the TBT Agreement.  The 
representative asked Canada to answer three questions :  First, on what basi s had the additives been 
included in the schedule, and how were they partic ularly appealing to the youth.  Second, would 
Canada consider amending the sche dule of products and additives affected by the ban to ensure that 
the ban only applied to cigarettes exhibiting discerni ble confectionery or fruit flavour.  Third, what 
specific evidence had Canada relied upon in relation to  its claims that blended tobacco products were 
more toxic, more addictive and more attractive to youth.  
187. The representative of Turkey
 reiterated his delegation's con cerns regarding the measure at 
issue and  referred to comments made by Turkey in  previous TBT Committee meetings.  While fully 
supporting the objective of the legislation, Turkey was of the opinion that the current legislation was more trade restrictive than necessary.  By means of  this measure, Canada prohibited the use of various 
additives in certain tobacco products.  As these kinds  of products, either ble nded or non-blended, were 
like products, any measure that would result in fa vour of prohibiting blended tobacco products was 
discriminatory in nature.  He added that the additi ves did not give any characterizing flavours to the 
tobacco product and the decision was made without considering their effects on final products.  In 
addition, there was no scientific evidence and the m easure was not proportionate with its objective. 
Turkey therefore requested Canada to provide r esponses to Turkey's comments and urged Canada to 
reconsider its decisions and amend the measur e in accordance with their TBT commitments. 
188. The representative of Chile
 supported the concerns raised by  other delegations.  Chile had 
sent a letter expressing its concerns to the Canadian  embassy in Chile and was still awaiting a formal 
response.  In this letter, Chile supported the objectiv e of the law and the Canadian authorities in their 
attempt to reduce smoking among young people.  Howeve r, in Chile's view, the scope of the law was 
much broader than that and it de facto  prohibited the import, manufacturing and marketing of 
American blended tobacco and cigarettes.  Chile  therefore supported the comments made by other 
Members and regretted that the measure by Canada  had not been notified to the WTO in accordance 
with transparency guidelines and particularly with Article 2.9 of the TBT Agreement.  Notification 
would have been necessary because the measure woul d affect products being marketed, including in 
Chile.  Furthermore, Chile held the view that th e Canadian measure was not consistent with the 
obligations stipulated in Articles 2.2 and 2.8 of th e TBT Agreement.  Chile's concern was that the law 
was going to have a negative impact on the trade of  the tobacco products concerned.  Chile was a 
Burley tobacco producer and Burley tobacco was used  in American blended cigarettes.  She explained G/TBT/M/51    
Page 42  
 
  that Chile had about 2,400 hectares of this cr op and its cultivation crop employed approximately 
1,000 workers. Tobacco companies had more than 25 per cent of its total production exported to over 
15 countries worldwide, including Canada.  Chile ther efore urged Canada to take its position into 
account with a view to reaching an understanding on this issue.   
189. The representative of Tanzania
 endorsed the statements made by the preceding delegations. 
As others, Tanzania supported the legitimate objec tive of the measure; however, in Tanzania's view, 
the bill, as currently drafted, was overly broad and vi olated Canada's trade obligations as a Member of 
the WTO and could impose serious and unnecessary economic and social hardships on Tanzania's 
tobacco producers, and affect long term developm ent prospects.  Tanzania was not opposed to the 
purpose of the Canadian Bill C-32 in as far as it  aimed at reducing the number of young people 
smoking, however, the extent of the contributio n of the measure to the objective, its trade 
restrictiveness, and the importance of the values and interests at stake needed be balanced.   
190. The Canadian Bill C-32 banned the use of a long list of different types of ingredients which 
were used in the production of many tobacco products, as well as in food, including natural components of the tobacco leaf. He noted that the ban applied regardless of the amount used or their 
effect on the flavour of the finished product.  Ta nzania's concern was that the Canadian Bill C-32 
would effectively place a total ban on traditional blen ded cigarettes, one of the two major categories 
of cigarettes in the world.  He explained that tr aditional blended cigarettes were produced with three 
types of tobacco, namely Burley tobacco, Virgin ia tobacco and Oriental tobacco. Many of the 
ingredients banned under Bill C-32 were critical co mponents of traditional blended cigarettes sold 
throughout the world.  Their use helped blend th e three different types of tobaccos and comprised 
elements of manufacturers' brand recipes.  The type and the amount of ingredients used in traditional 
blended cigarettes did not impart and/or exhibit an y discernible fruity, confectionery, or other flavour 
that might be perceived as attractive to young peopl e.  He concluded that there was an absence of 
scientific evidence presented by Canada as to how the "attractiveness" of tobacco products could in 
fact be assessed on any scientific basis. 
191. Tanzania's concern was that Bill C-32 establis hed a dangerous preceden t and could have a 
devastating impact on Tanzania's tobacco leaf expor t interests, tobacco products trade, and long term 
tobacco crop development prospects.  In particular , it was noted that Tanzania exported significant 
quantities of tobacco leaf around the world with an approximate annual crop volume of 79 million kilos of which over 90 per cent of that volume constitu ted Virginia flue cured tobacco.  He explained 
that approximately 98,000 farmers grew tobacco in Tanzania of which 91,000 farmers grew Virginia 
flue cured tobacco, making tobacco the leading ag ricultural cash crop generating more than US$ 160 
million per annum.  Tanzania feared that demand for Virginia flue cured tobacco leaf was likely to 
fall if manufacturers were unable to use ingredient s to manufacture traditional blended cigarettes.  
Such adverse consequences were avoidable by using less trade-restrictive measures consistent with 
WTO.  
192. The representative Tanzania continued explaini ng that the Bill C-32 contravened various 
articles of the TBT Agreement.  Article 2.2 of the TBT Agreement prohibited Members from adopting 
technical regulations that had the effect of creating "unnecessary obstacles to trade".  In particular, it required that "technical regulations should not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non -fulfilment would create."  It further stated, "in 
assessing such risks, relevant elements of consideration are, inter alia : available scientific and 
technical information, related processing technology or  intended end-uses of products."  For Tanzania 
the relevant legal question was therefore whether th e ban was more trade restrictive than necessary to 
meet the stated objective.  Furthermore, Article 2.8 of the TBT Agreement stated that "wherever 
appropriate, Members shall specify technical regulati ons based on product requirements in terms of 
performance rather than design or d escriptive characteristics".  In Ta nzania's view, it was possible to 
achieve the same objective of reducing the percei ved attractiveness of some tobacco products to  G/TBT/M/51  
 Page 43 
 
 
  young people in other non trade-restrictive ways.  Other WTO Members had adopted a performance-
based standard to regulate tobacco product ingredient s.  Tanzania was of the opinion that Canada was 
in violation of Article 2.8 of the TBT Agreement, as Canada had regulated the design of the product, 
in the form of its composition, without regard to how the ingredients affected the performance of the 
tobacco product in the form of its characteristic flavour.  The "performance-based" approach appeared 
to be in line with the TBT Agreement, was more precise and more proportionate than an approach 
banning a long list of ingredients in any quantity and without considering their effect on the flavour of 
the final tobacco product.  Tanzania therefore urged Canada to consider adopting a similar 
performance-based approach. 
193. Furthermore, the representative of Tanzania noted  that Bill C-32 was not in line with Article 
2.9 of the TBT Agreement. Because of lack of a re levant international sta ndard on the production of 
tobacco products, and because of the significant tr ade impact of the Canadian Bill C-32, prior to 
signing the Bill, Canada should have published a notice at an early and appropriate stage, in such a 
manner as to enable interested parties from othe r Members to become acquainted with the proposed 
Bill. Canada should also have notified other Member s at an early and appropriate stage, through the 
WTO Secretariat, of the products to be covered by the proposed bill t ogether with a brief indication of 
its objective and rationale.  Referring to Article 2.10 of the TBT Agreement, he noted that if Canada 
had considered the sale of flavoured  cigarettes as an urgent problem of safety, health, environmental 
protection or national security, Ca nada should have notif ied immediately other Members through the 
Secretariat of the presence of Bill C-32 and the pr oducts covered, with a brief indication of the 
objective and the rationale of the said Bill, including the nature of the urgent problems.  
194. Tanzania was of the opinion that the implica tion of Bill C-32 was also inconsistent with 
Canada's obligations under NAFTA . Article 904(4) of NAFTA stated, in part, that "No party may 
prepare, adopt, maintain or apply any standards relate d measure with a view to or with the effect of 
creating an unnecessary obstacle to trade between parti es".  In the context of Article 2.2 of the TBT 
Agreement, Bill C-32 created an unnecessary obstacl e to trade within the respective region, and 
brought to issue Canada's consis tency under international trade law and further raised concerns on 
equitable treatment of Members.  Finally, referring to Article 12.3 of the TBT Agreement, he recalled 
Tanzania's status as a Least Developed Country (L DC) and requested that Canada adapt its domestic 
objective of reducing the appeal of certain tob acco products to young people with a less trade 
restrictive approach. 
195. The representative of Brazil  stated that despite the fact that Brazil was fully in favour of the 
objectives pursued by the Canadian legislation, Braz il continued to have conc erns about the possible 
trade impacts of the measure.  In particular, Braz il was interested to know whether sugar was one of 
the ingredients that were contained in the F AO/WHO and US Food and Drug Administration (FDA) 
lists of additives which Canada had indicated as one of the basis for the regulation. 
196. The representative of Zambia  supported the concerns raised by other Members on the 
Tobacco Act in Canada.  He noted that Bill C-32 banned the use of different types of ingredients 
including those which were essential component of tr aditional blended cigarettes.  The use of some of 
the banned ingredients helped blend the three types of  tobacco (i.e. Virginia, Burley and Oriental) and 
also helped to replace many of the natural compone nts of the tobacco leaf that the cu ring method 
destroyed in some tobacco types.  He noted that blended cigarettes were one of the major categories 
of cigarettes in the world and therefore the ban of these ingredients also effectively banned traditional 
blended cigarettes, despite the fact that the type  and the amount of the ingredients used in the 
traditional blended cigarettes did not impart any speci fic fruity or confectionary flavour that might be 
attractive to young people.  In Zambia's view the measure was an unnecessar y obstacle to trade in 
tobacco products and Zambia urge d Canada to adopt a less trade restrictive measure to address their 
legitimate concern.  G/TBT/M/51    
Page 44  
 
  197. The representative added that in the current fo rm, Bill C-32 would not only negatively affect 
tobacco producing countries such as Zambia, but also  affect their future development prospects. 
Zambia had been making efforts to diversify the economy and part of these efforts had been to 
increase production and exports in agricultural prod ucts, which included tobacco. He informed the 
Committee that 20 per cent of Zambia's agricultural exports were tobacco of which more than 60 per 
cent was auctioned in Malawi.  The auctioned tobacco was used to produce traditional blended 
cigarettes amongst other types of cigarettes by adding  some of the banned ingredients and re-exported 
to other countries, including Canada.  Therefore, Bill C-32 had the potential of negatively affecting 
Zambia's tobacco leaf exports and the livelihood of hundreds of farmers.  
198. The representative of Uganda
 (G/TBT/W/331) shared the concerns raised by other Members. 
He explained that Uganda was one of the major tobacco growing countries in Africa and was thus 
concerned about the effects of Canada's measure on its tobacco leaf manufacturing and exports.  He 
noted that the law prohibited the manufacture and sale  of cigarettes, little cigars and blunt wraps that 
contained any of the flavourings and additives listed in a schedule appended to the law.  Uganda was 
deeply concerned that this law was inconsistent with Canada's obligations  under the TBT Agreement 
and would have a negative effect on Ug anda's long term economic prospects. 
199. Whereas Uganda fully supported the objective of Canada to reduce the incidence of youth 
smoking, however, Uganda was concerned that the law was far too restrictive to trade than was 
necessary to achieve this objective. Specifically, Uganda was concerned that the law effectively 
banned traditional blended cigarettes,  which were one of the two majo r categories of cigarettes in the 
world.  Traditional blended cigarettes were produced  with three types of tobacco (Virginia, Burley 
and Oriental tobacco) and blended with certain a dditives that the law sought to prohibit, but which 
were an essential component of traditional ble nded cigarettes.  The additives were applied as 
manufacturing aids to blend the three different typ es of tobaccos and as flavourings to confer on each 
brand its unique tobacco taste. Additives in traditi onal blended cigarettes did not lend a characterizing 
fruit or confectionary flavour to the end product.  Thus, by banning the additi ves, the law effectively 
banned traditional blended cigarettes, even thou gh such cigarettes did not exhibit any discernible 
confectionary, fruit or other flavour that was particularly attractive to youth. 
200. He informed delegations that Uganda was a signi ficant producer of tobacco leaf in the world, 
with an approximate annual crop volume of 37 million kilograms of which over half of that volume 
constituted burley tobacco.  He reported that appr oximately 76,810 farmers gr ew tobacco in Uganda 
of which about 36,000 of these farmers grew Burley  tobacco.  Over 95 per cent of Uganda's total 
annual tobacco crop was exported to cigarette manuf acturers worldwide generating annual revenue of 
US$ 66 million.  Measures which restricted blended cigarettes would, therefore, have a detrimental 
impact on Uganda's tobacco produc tion and tobacco exports which had been the leading export cash 
crop for several years. 
201. In Uganda's view the issues that the Canadian la w raised could easily be resolved by equally 
effective but less trade-restrictive alternatives that  would address the objective of the legislation but 
also ensure compliance with Canada's obligations under the TBT Agreement.  In conclusion, given 
the significant repercussion of the Canadian legi slation, Uganda requested a response from the 
Canadian authorities to the list of questions cont ained in the written communication that had been 
circulated by the Secretariat the day before as a document.  While Uganda fully supported the purpose 
of this law, namely to address the problem of youth smoking encouraged by candy and fruit flavoured 
tobacco products, Uganda was of the opinion that the Canadian measure was far too restrictive.  
202.  The representative of Jordan  explained that his delegation fully supported the objective of 
Canada's tobacco act, namely to reduce youth smoking .  However, Jordan was concerned that the law 
was overly trade restrictive in proportion to the ob jective it sought to achieve.  Jordan therefore 
supported the concerns raised by other Members a nd urged Canada to respond to these concerns.    G/TBT/M/51  
 Page 45 
 
 
  203.  The representative from the Former Yugoslav Republic of Macedonia  supported the 
statements by other Members and reiterated concerns  with the proposed bill.  As a producer of 
traditional tobacco, the Former Yugoslav Republic of  Macedonia held the view that there was a way 
to find a better balance between the obligations  which arose from the Framework Convention of 
Tobacco Control (FCTC) and economical aspects of the tobacco producers which had great social and 
economic impacts in developing count ry and developed country.  He urged Canada to  consider all 
questions and concerns from the Form er Yugoslav Republic of Macedonia. 
204.  The representative of Egypt  echoed the concerns raised and sought clarification from Canada 
on how the amended tobacco act was consistent  with Canada's obligation under WTO/TBT 
agreements.  
205.  The representative of Ecuador  recalled that the Canadian Bill C-32 had the effect of 
prohibiting the import of the type of cigarettes know n as American blend or traditional blend, which 
was the type of cigarette that blended Oriental, Virginia and Burley tobacco and which was produced 
and exported by Ecuador. Ecuador recognized Canada's right to pursue a legitimate objective by 
reasonable measures, however, Ecuador was concerned that Canada had failed to meet the obligations 
of Articles 2.2, 2.8 and 2.9 of the TBT Agreement.  Ecuador was of the view that the measure seemed 
to be an unnecessary obstacle to international trade because it failed to take into account the need for 
technical regulations to be based on the performan ce of products rather than the design and product 
characteristics.  The representative of Ecuador info rmed the Committee that given the trade effects 
that the act would have, it could potentially aff ect the economy of Ecuador since about 1,500 
Ecuadorian families, (about 6,000 workers), were dedicated to producing Burley tobacco and its 
blend, which were marketed in Europe and North America.  Ecuador asked Canada to provide an 
answer to the question how their legislation would affect the domestic production in Canada and thus 
the importation of tobacco from abroad.   
206. The representative of Honduras  expressed his concerns about th e implications of the amended 
tobacco law for its tobacco exports to Canada.  While Honduras shared the legitimate objective of the 
Government of Canada to protect the health of young people, Honduras considered the way in which 
it sought to achieve this objective as excessive becau se it created barriers to trade that were more 
restrictive than necessary. Along the same lines as other Member s, Honduras remained concerned 
about the compatibility of this law with Canada ’s obligations under the TBT Agreement, and the 
negative impact that this would have on long term  economic prospects.  Honduras therefore requested 
Canada to explain how it had ta ken into account the special n eeds of Honduras in drafting and 
applying the prohibition on use of additives as stipul ated in Article 12.3 of the TBT.  Furthermore, 
Honduras raised the question how Bill C-32 was co mpatible with Article 20 of TRIPS, which 
stipulated that the use of a trade or service mark  in commercial operations with special requirement 
should not be unjustifiably complicated.    
207. The representative of Guatemala  expressed serious concerns about Bill C-32 which had 
entered into force in Canada on 8 October 2009, and supported fully the comments made by other 
Members, especially by Mexico, Chile and Kenya.  He explained that the concern of Guatemala with 
respect to this law was twofold.  The first had to  do with the transparency obligations under the TBT 
Agreement, under which all Members had to notify and provide sufficient time to other Members to 
submit their comments for draft technical regula tion which could in one way or another affect 
legitimate commercial interests.  For Guatemala, it was a matter of serious concern that Canada had 
adopted and implemented the bill which had comme rcial implications wit hout having provided the 
necessary notification and without taking into account comments by other Members.  
208. Although Guatemala shared the objective pur sued by Canada under this legislation, 
Guatemala was of the view that the manner to achie ve this objective was exce ssive and created hidden 
barriers to trade which was incompatible with Artic le 2.2 of the TBT Agreement.  Furthermore, the G/TBT/M/51    
Page 46  
 
  new law discriminated against different types of tobacco which indirectly affected Guatemalan 
tobacco producers.  He reminded delegations that although the Canadian legislation prohibited the use 
of any additives, it was indirectly  prohibiting the tobacco blends and particularly the American blend, 
which created a precedent globally.  As Guatemala was a Burley tobacco producer which was used in 
these blends, Guatemala was very much concerned about the trade implications of the new law.  
Guatemala shared Canada's objective to seek to protect the help of young people; however, since 
Canada did not have any scientific evidence that th e use of all additives created flavours which could 
make the tobacco more attractive for certain parts of the population, Guatemala's view was that the 
measure was excessive and in viol ation of Article 2.2 of the TBT Agreement.  Guatemala urged 
Canada to review the regulations under Bill C-32 taking into account the comments made by 
Members to date as well as respecting the transparency obligations under Article 2.9 of the TBT 
Agreement. 
209. The representative of the Dominican Republic
 supported other Members that had expressed 
and reiterated their concerns regarding the adoption by the Government of Canada of Bill C-32 which 
prohibited the manufacturing and sale of traditional blended cigarettes.  She informed the Committee 
that Canada had not yet notified the measure to the TBT Committee, despite the fact that it could have 
an important impact on the sales of cigarettes, in particular of cigarettes produced with Burley tobacco.  The Dominican Republic cultivated different  types of tobacco that constituted the traditional 
blends.  The Canadian law would undermine th e tobacco production in the Dominican Republic 
having an impact on the national economy and creating social difficulties and loss of jobs.  As stated 
in the last TBT Committee meeting, she noted that  Canada should have notified the measure before 
adoption as stipulated under Article 2.9 of the TBT Agreement.  She recalled that the measure should 
have been debated and commented on by Members.   
210. The Dominican Republic observed that the law aimed at prohibiting the manufacture and the 
sale of tobacco products which included cigarettes,  small cigars and other tobacco products with 
certain characteristics such as confectionary fruit or fruit flavours.  Although the Dominican Republic 
understood the objective of this measure, the way in the which the measure had been drafted was 
overly broad and out of proportion: instead of prohi biting products with specific flavour, it prohibited 
products that contained at least one of the ingr edients in the list of more than five thousand 
ingredients, which were necessary for the manufacturi ng of cigarettes made up of the three main types 
of tobacco.  Taking into account the drastic effect th at the prohibition of such blended cigarettes with 
additives without any specific confectionary or fru it flavours, and that the traditional blend only 
represented one per cent of the total cigarette ma rket, for the Dominican Republic the prohibition on 
ingredients did not appear to pursue a public hea lth objective, but constituted an unnecessary technical 
barrier to trade, in violation of various provisions of the TBT Agreemen t, such as Articles 2.2 and 2.8.  
Therefore the Dominican Republic urged the Canadi an authorities to revise and amend the bill in 
question. 
211. The representative of Burundi
 stated that although Burundi understood the legitimate health 
concerns of Canada in establishing the Bill C-32, Bu rundi expressed deep concerns regarding this act 
and associated itself with the statements made by other Members.  The proposed amendment to the 
Canada tobacco act would not only affect Burundi as a tobacco producing country but also was more trade restrictive than necessary.  He noted that Keny a, Tanzania and Uganda were partner states in the 
East African Community and contributed therefore to  the regional integration and development efforts 
of this region.  In this regard, Burundi was also affected when those countries were affected.  Burundi 
urged Canada to provide a justification of the act  in light of the relevant provisions of the TBT 
agreements and to take into account  all concerns raised in this regard by other WTO Members.   
212. The representative of Malawi
 stated that his delegation rema ined deeply concerned about the 
new regulation by Canada (G/TBT/W/329).  As Mala wi was the largest producer of tobacco and that  G/TBT/M/51  
 Page 47 
 
 
  tobacco was the leading cash crop in the country.  Malawi recommended Canada to consider 
reviewing the regulation taking into account the qu estions raised by Malawi and other Members. 
213. The representative of the Philippines  shared the concerns raised by previous delegations about 
Canada's Bill C-32.  While supporting Canada's  objective to address public health concerns by 
reducing the incentives for young people to smoke, Bill C-32 appeared to be more trade restrictive 
than necessary.  The Philippines th erefore asked Canada to respond to the concerns and questions 
raised by Members on this legislation.   
214. The representative of Croatia  stated that the Amendment to Tobacco Act would effectively 
ban the manufacture and sale of traditional blende d cigarettes and would thereby significantly reduce 
imports of the burley and Oriental tobacco used in such cigarettes.  Since most of Croatian cigarette 
production was from the blended tobacco and half of Croatia's production was exported, Croatia 
perceived this measure as trade discriminatory and echoed the concerns raised by other delegations. 
215. The representative of Mozambique  joined other Members in expressing its concerns about 
Canada's Bill C-32. As a tobacco growing count ry, Mozambique was concerned about the possible 
effects of Canada's act on its tobacco leaf exports .  Like others, Mozambique fully supported the 
objective of Canada's law aimed to reduce the incidence of youth smoking by prohibiting the 
manufacture and sale of confectionary and fruit flav oured tobacco products that were designed to 
appeal to youth, however, Mozambique was con cerned that the law effectively banned traditional 
blended cigarettes produced with Virginia, Burley and Oriental tobacco, of which two types were 
grown in Mozambique.  He informed the Committee that tobacco was one of the five main export 
commodities of Mozambique and that Canada's la w would have a negative effect on Mozambique's 
export revenues and economic devel opment.  Mozambique therefore appealed to Canada to avoid 
negative effects that would damage economic pros pects of countries depending on tobacco exports.   
216. The representative of Zimbabwe  shared the concerns raised by other delegations regarding the 
impact of the Canada Bill C-32.  As a grower  of tobacco and manufacturer of tobacco products, 
Zimbabwe remained concerned about the likely negative consequences of the amendment to the 
livelihoods of the numerous small tobacco farmers in many of the concerned Members' economies.  
Had a thorough study been undertaken, including an  analysis of the pe rformance aspects of the 
tobacco products, alternative, less trade restrictiv e ways to deal with the young smokers problem 
would have been found to address the concerns of  Zimbabwe as well as other Members, while still 
meeting Canada's objectives to address the health concerns of its citizens. Zimbabwe hoped that 
Canada would take into account the comments made. 
217. The representative of Canada  explained that the  Cracking Down on Tobacco Marketing 
Aimed at Youth Act  responded to an important public health  objective of the Government of Canada. 
It applied to cigarettes, little cigars and blunt wr aps manufactured or sold in Canada, regardless of 
their origin.  She informed the Committee that the act received Royal Assent on 8 October 2009, and 
most of its measures had already come into force.   The section that prohibited the sale of tobacco 
products containing prohib ited additives would come into force on 5 July 2010. Among others, the 
new act banned the use of certain additives which contributed to making tobacco products more attractive to youth, in little cigars, cigarettes and blun t wraps sold in Canada regardless of their origin. 
She highlighted that the act did not ban any type of tobacco product or types of tobacco.  The 
government of Canada had made these changes to  the Tobacco Act to protect young people from 
marketing practices that encouraged  them to smoke. She stated that  Canada's obligations under WTO 
Agreements, including the TBT Agreement, ha d been taken into account during the Bill's 
development.  Canada was committed to respecting its  international trade oblig ations in meeting its 
policy objectives. G/TBT/M/51    
Page 48  
 
  218. The representative informed the Committee that at the last TBT Committee meeting in March 
2010, numerous questions had been posed by interv ening Members.  In answering these questions, 
Canada had grouped the responses into different themes.   She noted that several questions had already 
been answered by Canada in the March 2010 TBT Co mmittee meeting, and were therefore referred to 
as March 2010 TBT Committee meeting minutes (document G/TBT/M/50). 
219. In response to Malawi's question related to th e development of the schedule and selection of 
included prohibited additives, she noted that Cana da had replied to this question during the March 
2010 TBT Committee meeting and the response could be found in the respective minutes (document 
G/TBT/M/50).  
220. In response to questions received from multiple  Members regarding the scientific evidence 
used to develop the list of prohibited additives, she noted that Canada had provided a response at the 
March 2010 TBT Committee Meeting.  In summary, this response had stated that there was sound evidence that certain additives, including flavour s, did increase tobacco product attractiveness. The 
tobacco industry's own documents, made public as a result of litigation, had shown that the use of 
additives helped to make tobacco products more app ealing to young people.  In  addition, Canada had 
prepared a list of references of the numerous public ly available studies that had examined the use of 
additives that increased the appeal of tobacco product s. This 14-page list of references was available 
for interested Members as a Room Document.  
221. In response to questions received from multip le Members regarding the relationship of 
additives to tobacco product types targeted in th e schedule, she reiterated that there was sound 
scientific evidence that additives, including flavours, were used by  tobacco manufacturers to make 
their tobacco products, including cigarettes with ble nded tobacco leaves, more appealing.  Canada's 
Act was aimed at prohibiting the use of additives in all cigarettes, little cigars and blunt wraps 
manufactured in, or imported into, Canada that cont ributed to making these products more attractive.  
To respond to the questions by the European Uni on and other Members on the treatment of domestic 
and imported tobacco products, she clarified that the measure achieved uniform levels of protection in 
relation to all forms of tobacco, no matter wh ether imported or domestically produced.  
222. In response to Malawi's question regarding the possibility of amending the list of prohibited 
additives of targeted products, she noted that pursu ant to Section 9 of the amended tobacco act, the 
Governor in Council had the authority to ame nd the schedule by order; however, no amendments 
were under consideration at this time.  With r espect to flavours, limiting the restrictions to 
confectionary or fruit flavour would only, in Canada 's view, not address the problem of attractiveness.  
For example, Canadian smokers could find that ot her types of flavour might also make cigarettes 
more attractive, such as butter flavour. 
223. To respond to a question posed by Argentin a during the March 2010 TBT meeting regarding 
the development of the list of excluded additives including menthol in the schedule of prohibited 
additives, she noted that this list had been refined during the hearings held by the House of Commons 
(Canadian Parliament).  During these sessions Member s of the public, government officials, health 
advocates, tobacco retailers and tobacco manufacturer s had been asked to comment on the schedule of 
prohibited additives.  Typically, except for ment hol, l-menthol and l-menthone, the 21 chemicals 
excluded from item 1 of the schedule "Additives that ha ve flavouring properties" were not expected to 
either impart or enhance flavour. Sh e informed delegations that the mi nutes of all deliberations in the 
two chambers of the Canadian Parliament on the Cracking Down on Tobacco Marketing Aimed to 
Youth Act
, including discussions on how the list of ex cluded additives had been developed, were 
available to the public online (www.parl.gc.ca).  Wi th respect to the exclusion of menthol, menthol 
cigarettes were used by only 2 per cent of smokers in Canada and their sales had been declining for 
several years.   The Cracking Down on Tobacco Marketing to Youth Act  had been designed to protect 
youth from those additives that increased the appeal of cigarettes, little cigars and blunt wraps.  G/TBT/M/51  
 Page 49 
 
 
  224. In response to multiple Members' statements related to concerns that Canada's list of 
prohibited additives was too broad or that Canada  should adopt similar approaches used by other 
countries, she noted that Canada's response was in the record from the March 2010 TBT Committee 
meeting (document G/TBT/M/50).  In summary, she stated that the Canadian approach had been 
deemed to be the best fit to address the public health problem faced by Canada.  
225. In response to the EU's question on what ot her initiatives Canada had introduced or would 
introduce to protect youth, she reminded Members of the other important provisions in the Cracking 
Down on Tobacco Marketing Aimed at Youth Act. She pointed out that tobacco use caused 37,000 
premature deaths a year in Canada and was also re sponsible for 4.4 billion Canadian Dollars in direct 
health care costs. In addition to the prohibition on certain additives, the new Act contained measures 
that were meant to protect children and youth from tobacco industry marketing practices that 
encouraged them to use tobacco products. For in stance, the new act required that little cigars and 
blunt wraps be sold only in packages of at least 20 units, similar to the requirement that had been in 
place for cigarettes since 1994. These products had been previously sold in Canada in single units or 
in small-quantity "kiddy-packs" and had been deem ed unduly affordable to youth because of their low 
price. The new act also prohibited tobacco indus try advertising that had been taking place in 
publications that could be viewed by children and youth. She emphasized that the Canadian 
Government was committed to dealing with youth smoking issues and that it employed multi-faceted 
approaches, such as policy development, regulati ons that restricted youth access to tobacco products, 
mass-media programming, second-hand smoke messag es, school-based materials, involving youth in 
tobacco control activities, and provision of r esources and tools for youth to take action.  
226. In response to several Members' questions regarding the notification of the legislation, she 
referred to Canada's response at  the March 2010 TBT Committee Meeting during which Canada noted 
that when Members had made Canada aware of the l ack of notification of Bill C-32, it had already 
been too late to notify under Article 2.9.2 of the TBT Agreement.  She, however, underscored that it 
had never been the intention of Canada to hide  the legislation from other WTO Members and that 
Canada had a very transparent legislative process. She emphasized that Canada was very mindful of 
the comments that had been made by WTO Member s at the TBT Committee.  In addition, if any 
technical regulations were to be considered to im plement this tobacco legislation, they would be 
notified to the WTO at an early stage.  Finally,  she informed the Committee that Canada had taken 
note of all the statements that had been made dur ing that day, including comments from Tanzania on 
the NAFTA Agreement, and that the ques tions would be sent back to  capital. 
(xviii)  Chinese Taipei – Organic Products (G/TBT/N/TPKM/65 and 69) 
227. The representative of the European Union  reiterated his delegation's concerns with regard to 
Chinese Taipei's new management system of importe d organic products. He appreciated the fact that 
Chinese Taipei had extended the equivalence r ecognition to one of the "new" European Union 
member States (Hungary), on the basis of supplem entary information subm itted.  However, the 
European Union continued to consider the distinc tion made by Chinese Taipei between 'old' and 'new' 
European Union member States' organic systems as  unjustified and therefore urged Chinese Taipei to 
extend its approval to all European Union Member States. 
228. The representative of Chinese Taipei  informed the Committee that on 2 February 2010 all 
required information had been received from Hunga ry, which, after a thorough review process, had 
led to the recognition of Hungary's organic regime  as equivalent on 21 May 2010.  He stated that 
Chinese Taipei encouraged other new EU member Stat es to provide the same relevant information as 
Hungary had done in order to facilitate the recogn ition of equivalence and that Chinese Taipei was 
willing to discuss the issue directly with  the European Union at any time.  G/TBT/M/51    
Page 50  
 
  (xix) Indonesia – Regulation of BPOM No. HK.00.05.1.23.3516 relating to distribution license 
requirements for certain drug products, cosmetics, food supplements, and food 
229. The representative of the European Union
 raised concerns with regard to a regulation by 
Indonesia which limited the granting of distribu tion licences for drugs, traditional drugs food 
supplements, cosmetics and foods that were s ourced from or contained so-called "un-Halal" 
substances and/or alcohol to emergency situations on ly.  She stated that there was a lack of clarity 
with regard to the definition of an "emergency s ituation", what the evaluation process for granting a 
license in such cases would entail and what the time frame for awarding a license for emergency 
reasons would be. While the European Union respected Indonesia's right to regulate the trade in Halal 
products, it believed that the current voluntary Hala l-labelling system was sufficient and less trade-
restrictive.  The European Union requested fro m Indonesia an update on its ongoing revision process, 
and asked that the draft measure to be notifie d to the TBT Committee to allow for comments. 
230. The representative of the United States  remarked that Indonesia had not notified this measure 
and that the new requirements were unclear in several  respects, and could restrict exports of certain 
food and food supplements, drugs (such as gelatin e capsules, vaccines, and cough syrups), and 
cosmetics products to Indonesia.  Because of conf usion, the decree could perhaps disrupt trade in 
critical medicines, such as vaccines, to Indonesia as well as negatively impact trade in other products 
as well.  The Decree indicated that the use of traditional drug products, cosmetics, and food 
supplements were "in general not emergency" and, thus it appear ed that products sourced from, 
containing, or derived from, certain animal substances would presumptively not be given a 
distribution license. The United States asked fo r confirmation that the decree had not been 
implemented and for the status of Indonesia's review process. 
231. The representative of Indonesia  informed the Committee that the regulation was being 
reviewed by the National Agency for Food and Drug C ontrol.  He noted that the part of the decree 
that referred to food and beverage  was being linked to an existing regulation entitled "Criteria and 
Assessment Procedures for Food Products".  The pa rt of the decree referring to food supplements and 
therapeutic products was linked to an existing regulation entitled "Criteria Procedures of Registration 
for Traditional Medicine and Herbal Medicines".  Fu rthermore, the part of the decree referring to 
cosmetic products was being linked to an exis ting regulation entitled "Cos metic Products".  He 
informed delegations that the Indonesian notifica tion Authority and Enquiry Point had sent a letter to 
the national agency for food and drug control to en courage them to notify its revised regulation in 
accordance with the TBT Agreement. He confirmed that the regulation was not in yet in force. 
(xx) China – WAPI standard requirements 
232. The representative of the United States  raised continued concerns about China's requirement 
that mobile handsets with WiFi be dual enabled with  the WAPI wireless sta ndard.  He understood that 
in 2009, China's Ministry of Industry and Info rmation Technology (MIIT) had established a process 
for approving hand-held wireless devices such as cell phones and smart phones that were Internet-
enabled.  However, MIIT had indicated to United States government officials in bilateral discussions 
that it would approve devices that used the WiFi standard only if the devices were also enabled to the 
WAPI standard. 
233. The United States was not aware of any written or  published measure providing for this dual 
enabling requirement, and, to date, China had not not ified this requirement to the WTO.  Because the 
measure had not been published, the United States w as not aware of written explanations for the basis 
and technical aspects of the measure.  Moreover, there had not been opportunity for stakeholders to 
comment meaningfully.  Furthermore, the WA PI standard with which China was mandating 
compliance did not appear to have been developed in an open, transparent consensus-based process. 
Therefore, the United States requested an explanati on for why China had not published this particular  G/TBT/M/51  
 Page 51 
 
 
  measure and a technical explanation for why the WiFi  standard – which was in widespread use in the 
global marketplace – was not used to achieve China's objectives.  He asked for a copy of the measure 
and noted that, as previously discussed, applicatio ns for approval by companies were not evidence 
that there were no concerns with the requirement; rather, companies had no choice but to make such 
applications if they wanted access for their mob ile devices in the world's leading mobile handset 
market. 
234. The representative of China  informed the Committee that in order to guarantee the safe 
operation of wireless ne tworks and to provide a more relia ble service, China telecommunication 
operators wished to provide options for users to choose wireless networ k products and relevant 
equipment which supported both WAPI and ISO ICE 802. 11i at the same time.  In order to meet 
market needs and promote industria l development, in 2009, the Ministry of Industry and Information 
Technology had launched a network access test for mobiles which supported WAPI and ISO ICE 
802.11i.  This was done on the basis of voluntary applications from enterprises. So far, nearly 100 mobile models had passed the test.  The representative stated that the implementation of the test of WAPI handset network access met the security needs of consumers and was not contrary to the spirit 
of the TBT Agreement.  Taking into account of i ndustrial and merger needs however, this may be 
changed in the future if deemed necessary. 
(xxi) Indonesia – Decree No. Kep-99/MUI/III/2009 relating to Halal certification   
235. The representative of the United States
 said that while the United States respected Indonesia's 
right to regulate trade in halal products, he was of the view that the regulations for approving halal 
certifiers needed to be developed in a manner that  was transparent and did not disrupt trade. In 
previous interventions the United States had raised concerns about a lack of notice and clarity in the 
requirements which had impacted the ability of Un ited States certifiers and producers to be approved 
through the new process.  The United States th erefore requested from Indonesia an update on the 
status of its process for accrediting additional certifiers. 
236. The representative of Indonesia  said that following the United States concern about a new 
decree regarding halal certifiers issued on 22 Oct ober 2009, which did not include any certifiers for 
poultry or lamb, Indonesia had consulted with th e Indonesian Assessment Institute for Food and 
Drugs of the Indonesian Consul of Ulam, who had in formed that the recognition was mainly based on 
requests and intended for re-evaluation proposals done by the Indonesian Consul of Ulam.  Therefore 
the decree only covered the types of slaughters that ha d been requested so far, but this did not mean 
that Indonesia Consul of Ulam did not accommodate recognition for poultry or lamb slaughters. 
Furthermore, on 14 April 2010, the Assessment Institute for Food and Drug and Cosmetic of 
Indonesian Consul of Ulam had met with the repr esentative of the United States of Department of 
Agriculture, and the meeting had concluded in a mu tual understanding that recognition for poultry and 
lamb slaughters in the United States could be done  through individual applications from slaughterers 
to the Indonesian Consul of Ulam.  Indonesia had also responded to the US TBT Enquiry Point by an 
official letter and by email on 18 May 2010.  Concer ning the notification of the revised regulation, 
Indonesia had forwarded the letter to the Assessme nt Institute for Food and Drug of the Indonesian 
Consul of Ulam to encourage them to notify th e new regulation according to the TBT Agreement. 
(xxii)  Thailand – Health warnings for alcoho lic beverages (G/TBT/N/THA/332 and Add.1) 
237. The representative of the European Union  asked Thailand for further information with regard 
to the scientific evidence leading to  the decision by Thai authorities not  to use less trade-restrictive, 
less costly and burdensome alternatives to pictorial health warnings.  She asked for a clarification on 
the scientific data justifying the assumption that the conditions described by the health warnings were 
generally caused by any level of alcohol consumption,  even moderate ones.  Furthermore, it was the 
EU experience that public policies aiming to modify drinking behaviour needed to be approached in a G/TBT/M/51    
Page 52  
 
  holistic manner, for instance by encompassing educati on campaigns to raise the awareness level of the 
public with regard to specific alcohol-related pr oblems.  Therefore, the European Union asked 
Thailand to indicate whether it was considering also other alternatives to mandatory product labelling, 
such as education and/or information activities.  
238. The representative of the European Union noted  that if the Thai authorities nevertheless 
decided to go ahead with the introduction of these requirements, the European Union requested more 
flexibility with regard to their implementation – in pa rticular, with regard to the size and placement of 
the health warnings. The European Union also ask ed Thailand to allow for a sufficient transition 
period for economic operators to adapt their labels to the new requirements. Finally, the European 
Union reiterated its request for Thailand to clarify the relationship between the draft measure and the 
text notified under G/TBT/N/THA/282.  
239. The representative of Mexico
 raised concerns about the mean s by which Thailand's legitimate 
objective of protecting human health was to be ac hieved and requested that Thailand consider less 
costly and less trade-restrictive alternatives, as  well additional scientific and economic reasoning 
behind the provision.  He pointed out that exporters would require sufficient time to be able to adapt 
to Thailand's proposed modifications of the regulation. 
240. The representative of the United States  said that the United States had difficulties 
understanding the scientific and technical basis Tha iland had used for the language in the warning 
statement requirements, and would review the furt her information supplied by Thailand. He also 
expressed his delegation's concern that the propo sed labelling requirement could interfere with 
legitimate trademarks on the bottle, as well as with the display of useful information on product 
labels, including information that was necessar y to distinguish one product from another. 
241. The US industry had informed the United States trade representative th at the requirement to 
rotate the warning labels every thousand bottles w ould require a stop and a change in the production 
line every three to four minutes, which would be ex tremely difficult for suppliers to manage and very 
disruptive to the production process. The United Stat es also asked that the implementation period be 
extended to allow time for suppliers to make the mo difications that were being proposed . Finally, the 
United States was concerned that a Thai requirement  for warning messages in media advertisements 
for alcoholic beverages had already been impl emented, even though comments on these warning 
messages were still under consideration. 
242. The representative of Australia  asked whether Thailand had considered less trade restrictive 
alternatives and shared the concerns of other Member s in relationship to the la bels and pictorials, and 
rotational labels, as well as the already implemente d measures with regards to warning messages in 
advertising for alcoholic beverages. 
243. The representative of Chile  was of the view that alcohol  consumption in itself was not 
harmful, and while excessive alcohol consumpti on was dangerous, moderate  alcohol consumption 
could even have beneficial effects for human health  as had been demonstrated by many international 
studies. She noted that the consumption of alcohol and in particular of wine, had been a common 
practice for many centuries. The moderate consump tion of alcohol had historically always been 
accepted, as it was not considered to be harmful.  Therefore, Chile believed that only excessive 
consumption of alcohol should be preven ted, not the consumption of alcohol per se . Furthermore, at a 
conceptual level, the proposal could potentially serve  as a precedent for many food products which all 
had the potential to harm human health when consum ed in excess. Chile believe d that the objective of 
preventing excess alcohol consumption could be attain ed with less trade restrictive practices. Chile 
also was concerned by the large size of the labels proposed by the Thai authorities and proposal that 
warning messages should instead take up l ess than 15 per cent of the label space.  G/TBT/M/51  
 Page 53 
 
 
  244. The representative of Argentina  recalled that his delegation had submitted comments and 
questions to Thailand four months previously, to date without response. Argentina recognized 
Thailand's legitimate objective to protect human health and specifically to prevent problems 
connected with a high consumption of alcohol among young people.  Nevertheless, Argentina felt that 
the measure was unnecessarily costly as it deviated from the legislation of all other Members.  
Argentina joined other Members in requesting furthe r information on the scientific basis underlying 
the proposed warning statements. 
245. The representative of New Zealand  acknowledged that in seeking to address the public health 
concern of the harmful use of alcohol, Thaila nd's draft Notification on labelling of alcoholic 
beverages was directed toward  a legitimate public health obj ective. However, the proposed 
requirements could be unnecessarily trade restrictive;  alternative, less trade-restrictive approaches 
could be available to achieve the same objective.  He also noted that the new requirements would 
impose significant additional costs and administrati ve burden on exporters, which could result in a 
reluctance for exporters to service the Thai market and, therefore,  for trade to be reduced.  New 
Zealand was of the opinion that, in line with the "World Health Assembly Strategy on the Harmful 
Use of Alcohol", a proper balance between policy goals  in relation to the harmful use of alcohol and 
other public policy goals should be achieved.  Finally, New Zealand expressed its interest in learning 
about the background leading to the selection of  the proposed labelling approach, including 
information on what alternatives had been considered  to achieve the same objective, for example the 
development of public education ca mpaigns and consideration of cu rrent international practices.  
246. The representative of Thailand  said that the notification had been submitted in accordance 
with the TBT Agreement.  In accordance with Article 2.2, th e measure pursued the legitimate 
objective of protecting human health.  In accordance with Article 2.1, the regulation would apply to 
both domestic and imported goods wit hout discrimination.  The measure had been notified properly, 
and in line with Article 10.6, and Members’ had been given opportunity to comment.  Thailand had 
initially allowed for a comment period of 60 da ys, as recommended by the TBT Committee, and had 
even extended this period by a further 30 days.  All comments had been taken into account by the 
relevant authority, which was the Disease Control De partment of the Ministry of Public Health. The 
measure envisaged a transition period of 180 days after its publication in the Gazette. 
247. The representative of Thailand went on to state that  her country did not consider alcohol to be 
an "ordinary" commodity due to its potential adverse effects on health, as well as on social 
development and economic growth.  Thailand considered the choice to drink an individual right, 
however felt that the addressing of alcohol-re lated problems was a public responsibility.  The 
consumption of alcohol had historically not been traditional in the Thai society.  The two major 
religions Buddhism and Islam, which were followe d by an estimated 99 per cent of the population, 
both discouraged and even prohibite d the consumption of alcohol.  Nevertheless, the Ministry of 
Public Health did not endeavour to eliminate the consumption of alcohol from Thai Society, and did 
not oppose drinking per se , however, it intended to combat alcohol-related problems in a cost-
effective and sustainable way.  To achieve this goal, the Ministry had elaborated its measure to 
include a mix of policy interventions. 
248. The representative of Thailand explained that the ban on small-sized bottles for alcoholic 
drinks was intended to reduce the occurrence of unde rage drinking, since small bottles were attractive 
to minors due to both their relatively cheap price, as well the possibility to be hidden from parents and 
teachers.  Thailand had already banne d "tiny bottles" nearly a decade ago.  She was of the view that 
all six pictorial warning messages had high c ontextual-relevance and were supported by both 
domestic and international scientific evidence.  They  were aware of studies indicating that moderate 
drinking might have health benefits for people w ith specific characteristics. However, they pointed 
out that epidemiological evidence showed that no h ealth benefits could be measured at the aggregate 
level in countries with low prevalence of coronary  heart diseases, especially in low and middle-G/TBT/M/51    
Page 54  
 
  income countries like Thailand.  In Thailand, th e occurrence of diseases attributable to alcohol 
consumption had increased by 40 per cent from 1999  to 2004 in terms of "Disability-Adjusted Life-
Years (DALY)".  The 2004 value was 10.4 per cent of  the total health burden, which was twice the 
global average. Alcohol consumption was now consider ed the second greatest health risk factor to the 
Thai population.  The market for alcohol in Tha iland was characterized by increased consumption 
volumes, drinking frequencies, product varieties and exposure to direct and indirect alcohol marketing 
all leading to an increase in alcohol consump tion as well as in alcohol-related problems in Thai 
society. 
249. Evidence showed, according to th e Thai representative, that wa rnings on the packages of 
commodities entailing potential harm were an effec tive means to educate the general population about 
risks associated with the use of the item.  Furtherm ore, the higher the level of alcohol consumption, 
the higher also the level of exposure to the warn ing measures.  Experience with tobacco packaging 
had shown that pictorial warnings yielded a higher im pact than text-only messages.  At present, Thai 
drinkers exhibited low levels of awareness of the te xt-only warnings that were currently employed.  
The experts believed that the location of these messages as well as their small size could be one 
reason for this.  Therefore, the new measure re quired the pictorial warning messages to occupy 
between 30 per cent and 50 per cent of the contai ner surface, which would still allow displaying 
product information in the remaining space.  Pictoria l messages furthermore were able to reach parts 
of the population with low literacy rates.  Moreove r, pictorial warnings would deter children from 
drinking alcohol. It was the view of the Thai delegation that it was technically feasible to implement a rotation of warning messages.  Finally, it was poi nted out that the measure was embedded in the 
national agenda to combat alcohol-related prob lems, which included an education campaign. 
250. The representative of Mexico
 remarked that the statement by Thailand gave the impression 
that the decision of Thailand had already been take n without the consideration of all arguments raised, 
and of possible alternatives. 
251. The representative of Thailand  responded that the alternatives proposed so far included 
education campaigns in school and for the ge neral population, which Thailand had already 
implemented.  It was in addition to this that  the new measure was being proposed; she assured 
delegations that all concerns  would be taken into account. 
(xxiii)  United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
252. The representative of China  informed the Committee that on 12 May 2010, China's 
WTO/TBT Enquiry Point had submitted comments on the notification G/TBT/N/USA/518.  China 
was of the opinion that the proposed rules eliminat ed many regulatory exceptions for lithium cells and 
batteries from the UN recommendation for the trans port of dangerous goods.  This would impose 
stricter restrictions on the transport of cells a nd batteries and thus would significantly impact the 
international trade of lithium cells and batteries.  Ch ina believed that this was not in compliance with 
Article 2.4 of the TBT Agreement.  If the Unite d States insisted upon eliminating these exceptions, 
China requested that the United States provi de sufficient scientific justification.  
253. Moreover, the representative of China noted th at the United States was considering requiring 
a UN symbol to appear on all lithium cells and ba tteries.  However the United States' proposed law 
did not specify the testing and specification requirements necessary to obtain this UN symbol. Therefore, China proposed that the United St ates clearly specify the necessary testing and 
specification requirements and notify these to the WT O.  China requested the United States not to 
implement rules before the specific requirements and procedures had been made clear and other 
Members' comments had been taken into account.  G/TBT/M/51  
 Page 55 
 
 
  254. In addition, the notification provided 75 days  for mandatory compliance from the date of 
publication.  This would cause difficulties for the producers of developing country Members to adapt their production to the latest requirements of the United States.  Articles 2.12 and 5.9 of the TBT Agreement required Members to allow a reasonable interval between the publication of a technical 
regulation or conformity assessment procedure a nd its entry into force; the Doha Ministerial 
declaration adopted in November 2001 interpreted th at a reasonable interval was normally a period of 
not less than six months.  Thus, China encouraged the United States to faithfully implement the Doha 
Ministerial declaration and to provide a period of at least 6 months for transition.  At the same time, China requested the United States to provide special and differe ntial treatment to developing country 
Members by granting an even longer period for ope rators  in all developing country Members 
including China. 
255. The representative of the European Union
 informed the Committee that since the last 
Committee meeting, the European Union had anal yzed the draft and had observed that the new 
requirements were not in accordance with the UN Recommendations on the Transport of Dangerous 
Goods and the International Civil Aviation Organi zation (ICAO) Technical Instructions on the Safe 
Transport of Dangerous Goods by Air.  The Unite d States had explained in the previous Committee 
meeting that changes had been deemed necessary due to  several incidents of aircraft fires.  However, 
the European Union noted that the ICAO Dangerous  Goods Panel had also discussed these incidents 
and that a working paper had been presented.  However, none of these incidents had involved lithium 
batteries that had fully complied with the current  ICAO requirements.  Thus, simply amending the 
requirements further and imposing greater restric tions would not necessarily have prevented those 
incidents from occurring. Some amendments had been introduced, but a majority of the Panel 
Members had considered that there was insufficient justification to make any substantial changes to 
the Technical Instructions. It was agreed though that if evidence would subsequently be produced 
indicating that the current requirements were not adequate, the Panel would re-consider the 
requirements.  The European Union therefore invite d the United States to first implement the changes 
agreed at an international level and to abstai n from a unilateral approach.  If the United States 
nevertheless opted for a unilateral approach, the European Union would ask the United States to 
provide a transitional period of 18 months, sin ce the new requirements would oblige economic 
operators to make substantial changes to packaging, processes and logistics. 
256. The representative of Japan  raised concerns about the proposed restriction on the 
transportation of lithium batteries of the United States  from a point of view of the harmonization with 
the United Nations (UN) Recommendation on th e Transport of Dangerous Goods and the 
International Civil Aviation Organization (ICAO) Technical Instructions, as well as the impact on 
trade.  Moreover, the APEC Business Advisory Co uncil had submitted a letter to the United States 
Ministers responsible for trade, emphasizing th e harmonization of regula tions on international 
transportation safety.  Japan understood that the United States had received many comments both 
domestic and foreign, including from Japanese stake holders.  Japan requested that the United States 
seriously consider those comments. 
257. The representative of Korea  was of the view that the more effective way to secure safer 
transportation of lithium batteries was to ensure ha rmonization and compliance with the international 
standards and regulations, such as the UN, the IC AO or the IMO. Korea urged the PUMAS (pipeline 
and hazardous materials safety administration) to  provide sound scientific evidence on which the 
PUMAS had based its decisions. 
258. The representative of the United States  confirmed that the pipeline and hazardous materials 
safety administration in coordination with the US  Federal Aviation Administration had published a 
proposed measure to comprehensively address the issue of safe transport of lithium cells and batteries 
for aircraft.  This represented furt her steps in the continuing efforts to ensure that the transport of 
lithium batteries was safe and to prevent catastrophic accidents aboard aircraft; some examples of G/TBT/M/51    
Page 56  
 
  near misses had been provided in the last meet ing.  The proposed measures were intended to 
strengthen the current US regulatory framework by imposing more effective safeguards including 
testing, packaging, and hazard communication me asures for various types and sizes of lithium 
batteries in specific transportation contacts.  Taken together the proposal would eliminate some current exceptions for certain small batteries and in  doing so would enhance safety by ensuring that 
all lithium batteries would be designed to withstand normal transportation conditions, be packaged to 
reduce the possibility of damage that could lead  to an incident, and be accompanied by hazard 
information that would ensure appropriate and car eful handling by air carrier personnel and inform 
transport workers and emergency response personnel of actions to be taken in the event of an 
emergency. 
259. While the comment period for the proposed measure had expired on 12 March 2010, United 
States regulators continued to consider additional comments.  In addition to the formal comment 
period there had been a public meeting which had pr ovided an additional opportunity for stakeholders 
to comment.  Over 100 individuals from compan ies, associations, foreign embassies and other 
organizations attended and there had been numerous presentations.  All of the materials and analyses 
used in the development of the pr oposed measure as well as the statements made at the meeting were 
available on www.regulations.gov.  In terms of the status of the measure, United States regulators 
were currently still in the process of reviewing a ll the comments received.  The final measure was 
being developed and was tentatively expected to be issued in late 2010 or early 2011. 
260. The representative of the United States mentioned th at one of the issues that had been raised 
was that perhaps additional requirements were not  necessary to the ICAO Technical Instructions.  
However, the United States noted that the ICAO t echnical instructions did not cover the smaller 
batteries that the United States was proposing to cove r in its proposal.    The proposal therefore would 
strengthen the current regulations as there was strong evidence that small lithium batteries, especially 
when packaged in bulk, posed  the same risks of ignition as larger lithium batteries. 
261. The representative of the United States recalled that a second issue that had been raised was 
the allegation that the United States was deviating fro m relevant international standards. References 
had been made to the ICAO technical instructions  and the UN manual of tasks.  The representative 
noted that United States regulators regularly partic ipated in the work of these bodies and that they 
considered these documents when regulating.  Howe ver, there was evidence that neither the ICAO 
technical instructions nor the UN manual of task s had been developed in accordance with the TBT 
Committee's 2000 decision containing a set of princi ples it considered important for international 
standards development.
6 (the TBT Committee Decision). Specifically, the ICAO technical committee 
that developed the technical instructions and othe r relevant documents empl oyed a panel of the air 
navigation commission.  Such panels were not open to all WTO Members and paragraph 4 of the 
directive for the panels of the air navigation commissi on indicated that panels needed to be kept small, 
normally between 12 and 15 Members, and that the commission itself selected the countries that it 
would invite to participate "from those who are know n to have the necessary expertise in a technical 
field of concern".  The commission looked for Members that among other things "were able to provide ready access to research facilities and supporting expertise".  As a result of these criteria, most of the Members of this body were adva nced developed countries and seven of the 13 
participating Members including the Chair were re presentatives of European Union member States.  
Furthermore, voting was by majority vote, not by consensus and specifically article 15.4 of the 
working procedures provided that "the panel endea vored to reach unanimous agreement of Members 
on its recommendations to the commission.  Howe ver when a recommendation represented a majority 
decision of Members it was important that a report recalled the views of the minority as well as the 
                                                     
 
6 Decision on Principles for the Development of International Standards, Guides and Recommendations 
with Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part 
I, Section III (pp. 10-12) and Annex B (pp. 37-39).  G/TBT/M/51  
 Page 57 
 
 
  view of the majority of Members and the measure of support for each view".  Given the large number 
of EU member States in the committee, they constitut ed an absolute majority in the meetings.  Thus 
the United States believed that the standards development process clearly favoured the interest of the 
European Union.  In fact, member States met form ally as a group prior to every panel meeting to 
reach a common position; thus the ultimate docum ents developed by that group were essentially 
adopted by the panel.  The air navigation commiss ion recently rejected the application of another 
European country to join the panel since that w ould enhance the current geographic imbalance.  The 
fact that the commission had rejected an applica tion from a WTO Member to join also demonstrates 
that ICAO did not run an open process as set out in the TBT Committee decision.   
262. Similarly, in the UN committee on the transport of dangerous goods which developed the UN 
manual, 26 governments were represented, of wh ich 14 were European Union member States who 
also went together as a block.  Given that decisions  in this working group were also taken by simple 
majority and not by consensus, the EU member Stat es effectively dictated the terms of the materials 
that were developed in that body, so essentially both of these bodies were developing a unilateral EU 
approach, which was why the United States was dec lining to adopt all of the portions of that 
approach.  As a consequence of these bodies' a pparent failure to follow the openness and the 
consensus principles of the TBT Committee Decisi on, the United States did not believe that the 
documents they developed would effectively respond  to regulatory needs in all cases.  Due to the 
majority of European Union member States, the Un ited States did not consider these documents to be 
globally relevant, and believed that also other count ries outside of the European Union would deviate 
from these regulations according to their specific regulatory needs.  The United States would note that 
if the Committee Decision principles were followe d in these bodies and all participants could have 
their views reflected in the final documents, ther e would be more widespread adherence to these 
documents, which would contribute to both global regulatory convergence in these areas and to the 
achievement of the United States' legitimate regul atory objectives in the area of aircraft safety. 
263. Finally, the ICAO air navigation commission had ru les dictating the panel to be very small 
and the commission was able to reject applications  for membership based on criteria which were 
skewed towards countries with technical expertise in  aircraft regulation, making it very difficult for 
most developing countries to join.  The United Stat es believed that many de veloping countries would 
be interested in helping to develop a standard fo r the safe transport of lithium batteries by aircraft 
through their territories.  Unlike many of the countries that did sit on the panel, most developing countries did not produce the subject batteries; thus  their absence from the panel and the discussion 
may also skew the contents of the final documents.  He noted that in the Fifth Review (G/TBT/26), 
the Committee had emphasized that broader stake holder involvement helped ensure an open and 
transparent process in line with th e disciplines on standardizing bodi es set out in the TBT Agreement 
as well as those contained in the TBT Committee Deci sion's principles.  Thus the United States failed 
to see how the ICAO commissions' process fulfilled  the development dimension of the Committee 
Decision, since most developing countries were unable to participate in their work.  The United States 
believed that this issue provided an illustra tion of why the committee had never designated 
international standardizing bodies.   
264. The United States further believed that it was cl ear from this example that the name of the 
body did not indicate whether or not it developed a re levant international standard; a deeper look into 
the process by which such documents were developed,  including with respect to adherence to the  
TBT Committee Decision principles, was necessary.  The United States hoped that this issue would 
prompt both the ICAO and the UN to review their r espective procedures and to revise them so that 
they could adopt the code of practice and fulfill the TBT Committee Decision principles. G/TBT/M/51    
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  (xxiv)  Brazil – Alcoholic Beverages (G/TBT/N/BRA/348 and Suppl.1) 
265. The representative of the European Union
 reiterated concerns w ith regard to Brazil's 
Ministerial Act No. 327 of 17 September 2009 and it s possible negative impact on European Union 
economic operators.  The European Union had subm itted comments on this notification in December 
2009 and had raised its concern in the March 2010 Committee meeting; and now requested from 
Brazil an update on its legislative pr ocess as well as a reply to th e written comments by the European 
Union. 
266. The representative of the United States  informed the Committee that  in bilateral discussions 
with Brazil regarding this measure the United Stat es had expressed its concerns about the potential 
impact of the measure on US exports of beer, wine and spirits. The United States had submitted 
comments to Brazil seeking clarification on sever al aspects of the proposed measure including the 
proposal to prohibit the use of certain abbreviati ons, illustrations and expressions commonly used in 
the labelling of alcoholic beverages. The United States  also expressed concerns regarding the need for 
certain mandatory formatting and advisory statemen ts. Furthermore, the tran sition period granted for 
labelling requirements may be insufficient due to the total redesign of the labe l that could be required 
for compliance. The United States hoped to continue to discuss these issues bilaterally, and requested 
an update on the status of the measure from Brazil. 
267. The representative of Brazil  informed the Committee that Brazilian authorities were still in 
the process of examining the comments received on the draft regulation on beverage labelling and 
assured delegations that those comments would be taken into account before the publication of the 
final measure.  He noted that although the d eadline for submitting comments on the draft regulation 
had expired, Brazilian authorities remained available to questions concerning the content of the draft 
regulation.  Since the draft was still being discussed internally by regulators, Brazilian authorities were not yet in a position to provide definitive answers on how several provisions of the draft would be implemented. He reminded dele gations that the objective of the new regulation was to guarantee an 
adequate level of information and protection for c onsumers and that the requirements laid down in the 
draft regulation applied equally to domestic  and imported alcoholic beverages.  
268. The representative of Brazil recalled that at the last meeting, the European Union had asked 
about the registration mark that imported beverages would have to have.  The representative of Brazil 
stated that the requirement of introducing this regi stration number related to the very fact that the 
beverage was imported.  Domestic  producers would face a similar requirement to insert a registration 
number of their product in their labels.  Brazil be lieved that these requirements were necessary in 
order to accord a sufficient level of protection for consumers, as registration numbers allowed 
interested parties to identify the person legally resp onsible for introducing the beverage in the market.  
The Brazilian authorities were of the view that allo wing registration numbers to be affixed by separate 
stickers would not offer the same level of protection. 
(xxv) Turkey – New conformity assessmen t procedures for pharmaceuticals 
269. The representative of the United States
 reiterated concerns about certain aspects of Turkey's 
new decree regarding conformity assessment procedures for pharmaceutical imports. On  31 December 2009, the Turkish Ministry of Health ha d issued a regulation, which had gone into effect 
on 1 March 2010.  As of that date foreign producer s were required to have their manufacturing plants 
inspected by the Ministry of Health which w ould issue a good manufacturing practice certificate 
unless the country of manufacture was party to a mutual recognition agreement with Turkey.  He 
emphasized that while the United States was not opposed to inspection requirements for 
pharmaceutical manufacturing facilities, his delegation had a number of concerns.  G/TBT/M/51  
 Page 59 
 
 
  270. The United States was concerned that the measur e had not been published in the Official 
Gazette in Turkey in its proposed form, and had no t been notified to the WTO.  Furthermore, the 
United States understood from its industry that ther e was an unofficial stand-still for new regulatory 
approvals that began before the measure was a nnounced in 2009 which was not reflected in any 
published document.  The United States asked Turkey  to explain its health and safety concerns 
relating to imports from particular countries that had prompted Turkey to discontinue its acceptance 
of the GMP certificates issued by foreign regulator y authorities, such as the United States Food and 
Drug Administration (FDA), and to explain why it would no longer accept such certificates.  The United States had made several requests for the da ta which Turkey indicated had substantiated the 
basis for the change, but to date had not received th e information.  The United States asked Turkey to 
indicate at its earliest opportunity any health or saf ety issues caused by products manufactured in a 
US FDA certified facility that had harmed Turkis h citizens and which had prompted Turkey to 
discontinue acceptance of such GMP certificates. 
271. The representative of the United States also not ed that its industry was concerned that the 
measure provided a very short (three month) period for suppliers to comply.  This, coupled with the 
lack of notification, had disrupted US exports of pharmaceutical products to Turkey.  Some of these 
products were being used to treat diabetes, heart a ttacks, osteoporosis and ot her ailments, so delays 
would negatively impact patients in Turkey that  were in need of these life-saving and/or life 
enhancing medications.  The United States industr y had reported that approximately 227 products 
were awaiting approval and that Turkey did not have  sufficient capacity to inspect all of the plants 
that needed to be inspected in the near future.  Given this apparent lack of capacity, the United States 
was concerned that the process for clearing these products could take several years, effectively 
preventing imports of these essential medications into Turkey.  The United States understood that there had been some follow up discussions between senior officials from the US government in the 
US-Turkey Economic Partnership Commission.  He welcomed opportunity to enhance 
communication and encourage greater dialogue between MOH and US industry on this and other 
issues. The United States also welcomed the opportuni ty to facilitate regulator-to-regulator technical 
discussions on issues relating to inspection procedur es and capacity as well as on information sharing 
on the methodology used in facility inspections. 
272. Given the procedural deficiency in the announcement and implementation of the new 
measure, the lack of data substantiating the need for the change, and the appa rent lack of inspection 
capacity, the United States requested Turkey to susp end the measure and to resume recognition of the 
GMP certificates issued by the FDA to restore patie nt access to medications.  The United States also 
asked Turkey to notify its measur e to the WTO so that interested parties could comment, and these 
comments could be taken into account by the Ministry of Heath.  Finally, and on a more general note, 
the United States noted that there had been several  measures from Turkey in recent years including on 
biotechnology labelling, medical devices, and inspec tion procedures for certain IT products where 
there had been no opportunity for interested pa rties to comment, and there had been no WTO 
notification.  Therefore, the United States requested Turkey to re-evaluate its internal transparency 
procedures with respect to increasing the number of st akeholders able to comment and to ensure that 
measures were properly notified to the WTO. 
273. The representative of the European Union
 joined the United States in expressing concerns 
with regard to Turkey's new requirements for pha rmaceuticals.  According to information received 
from European Union economic operators, the introd uction of the measure on short notice had already 
led to significant delays in the registration of ne w pharmaceutical products in Turkey, in particular 
since Turkish authorities did not appear to have  the necessary capacity to carry out all necessary 
inspections and to deliver the required GMP certific ate in reasonable time.  Difficulties were further 
compounded by the requirement for companies to s ubmit extensive documentati on in their application 
file.  Finally, the situation of products already on th e market and of those that were in the process of 
being approved when the measure was implemente d remained unclear.  The European Union noted G/TBT/M/51    
Page 60  
 
  that the measure had not been notified despite bei ng a technical regulation. Furthermore, the three-
month period between publication and entry into force was deemed to be too short for economic 
operators to be able to comply with the requireme nts.  Therefore, the European Union asked Turkey 
to revert to its previous prac tice and to recognize European Uni on GMP standards and certificates 
without additional administrative requirements. 
274. The representative of Switzerland
 shared the concerns expressed by the United States and the 
European Union and repeated that the measure s hould have been notified at an earlier appropriate 
stage when amendments could still  have been introduced and comme nts could have been taken into 
account.  The implementation period of three months  was inadequate and did not allow interested 
parties to become acquainted with the new meas ure.  According to the WTO TBT Agreement, 
Members needed to ensure whenever possible that  results of conformity assessment procedures from 
other Members were accepted, even when those procedures differed from their own, provided they 
were satisfied that those procedures offered an in surance of conformity with applicable technical 
regulations equivalent to their own procedures.  He noted that in Switzerland, GMP certificates from 
WTO Members were in general accepted as proo f for the GMP conformity of manufactures of 
finished medicinal products.  This had proven to be  workable and Switzerland encouraged Turkey to 
adopt a similar solution. At the last TBT Committee meeting, the Turkish dele gate had mentioned that 
Turkey's objective was to protect human health by  ensuring effectiveness, safety and quality of 
pharmaceuticals. Switzerland was interested in recei ving more information on quality problems with 
pharmaceuticals manufactured according to internationa l principles.  In addition, Switzerland asked 
whether Turkey had considered that the access barrier s to new medicine could even cause a threat to 
human health.  In conclusion, Switzerland invited Turkey to reconsider its new measure and to 
suspend its implementation. 
275. The representative of Turkey  informed the Committee that acco rding to the previous version 
of the regulation, GMP certificates had either been pr ovided by the Turkish Ministry of Health or the 
certificates issued by the authoriti es of the respective countries had been accepted.  However, as 
Turkey had explained at the March TBT Committ ee meeting, the withdrawal of more than 30 
products from the market in the last three years had prompted the Ministry to review its approach to 
GMP certificates.  The Ministry thus decided to unde rtake a more active role in compliance with the 
GMP requirement for the sake of protection of hum an health and life.  Therefore, the licensing 
regulation had been amended in April 2009 and becam e effective since March 2010 in order to ensure 
pharmaceutical products were safe, effective and me t the quality standards of the GMP regulation.  
276. The representative of Turkey stressed that th e objective of the amended procedure for GMP 
inspections was to ensure the protection of pub lic health and was in accordance with the WTO 
disciplines.  Moreover, both the GMP system and the assessment procedure were in line with 
international rules and guides and did not impose any additional restrictions or  burdens on importers.  
The Turkish Ministry of Health had been issu ing GMP certificates since the 1980s.  The Ministry 
performed GMP inspections and issued GMP certifi cates every two years for Turkish manufacturers.  
Thus, the Ministry had adequate capacity to acc ept all the applications for GMP certificates.  
Regarding the request for statistics that supported the adoption of a new policy, the Turkish MoH was 
still working on the information, since there could be  an element of confidentiality. The information 
would be communicated as early as possible. 
(xxvi)  Italy – Dairy products (G/TBT/N/ITA/13) 
277. The representative of New Zealand  said that her delegation remained concerned by the 
proposed Italian dairy law which had been notifie d to the TBT Committee in February.  This law 
included provisions proposing a ban on the use of protein in cheese-making, and also provided for the introduction of mandatory country of origin labellin g for milk and dairy ingredients.  New Zealand 
understood that the draft legislation was currently  the subject of discussion in Brussels between the  G/TBT/M/51  
 Page 61 
 
 
  European Commission and Italy and hoped that delib erations on the proposed law took account of its 
and other Members' concerns. 
278. The representative of Australia  said that her delegation remained concerned about the 
proposed decree.  Her delegation was particularly co ncerned about the ban on the use of milk protein 
in cheese-making.  Therefore, Australia remained in terested in the discussions and development of the 
decree. 
279. The representative of the European Union  confirmed that there were on-going discussions 
between the Commission and the Italian authorities with in the internal notification procedure context.  
For this reason, he was not able to provide fu rther information on the measure at this stage; 
clarification would be provided once the in ternal consultation process had concluded. 
(xxvii)  Canada – Ice-cream Butterfat Subsidy/Labelling Programme (previously raised under the 
description "Ontario ice-cream subsidy") 
280. The representative of New Zealand  recalled that this issue had been raised previously in the 
TBT Committee under the description of "Ontario Ice-Cream Subsidy".  The new description reflected New Zealand's evolving understanding of  this Canadian programme.  The programme had 
been rolled out nationally, and, in New Zealand' s view it could include bot h a subsidy and labelling 
element.  New Zealand had a number of systemic co ncerns with Canada's ic e-cream butterfat rebate 
programme.  In particular, specific details of the pr ogramme had been very difficult to obtain. Due to 
an apparent lack of transparency in the developm ent, design, and implementation of the programme it 
was impossible to determine if it was, in fact, an import replacement programme supported by the 
Canadian Government.  Therefore, New Zealand re iterated its request to Canada to provide more 
detail around the design of the rebate programme, particul arly with regard to the role of the Canadian 
Dairy Commission.  
281. It was recalled that last time New Zealand had raised the issue in the TBT Committee, Canada 
had noted that the role of the Canadian Dair y Commission was limited to pooling funds for the 
programme. Thus, New Zealand asked for an explanation of what su ch " pooling" actually entailed, 
and whether this indeed was the full extent of the Canadian Government's involvement in the 
programme. New Zealand was also aware of various suggestions (including recently in the Canadian 
media) that the butterfat rebate programme was lin ked to Canada's "blue cow" labelling programme, 
which was understood to be a labe l available for 100 per cent domesti cally sourced milk in Canada. 
New Zealand emphasized that, as with other elem ents with these issues, there was not enough 
information from Canada to verify this, and theref ore requested Canada's cl arification on the nature 
and extent of the linkages between the progra mme and the "blue cow" labelling programme. New 
Zealand was also considering raising the issue ag ain at the next meeting of the WTO Committee on 
Agriculture. 
282. The representative of Australia
 shared the concerns raised by New Zealand and wished to 
hear more information from Canada. 
283. The representative of Canada  took note of the concerns regarding the Dairy Farmers of 
Canada ice cream initiative; however, Canada failed to see the relevance of the WTO TBT 
Agreement.  The Dairy Farmers of Canada Ice Cr eam Initiative was a private contractual agreement 
between the Dairy Farmers of Canada, which was a non-governmental organization, and individual 
ice-cream processors.  The initiative was a pure i ndustry promotional programme and the government 
had nothing to do with it.  On the questions a bout media reports, it was not the government of 
Canada's role to comment on media reports regarding the actions of private entities.  On the issue of 
the involvement of the Canadian Dairy Commissi on (CDC), the initiative was neither a Government 
of Canada nor a CDC programme. The CDC mere ly calculated pooling returns on behalf of G/TBT/M/51    
Page 62  
 
  producers. Producers decided themselves how they dis posed of their revenues.  Finally, Canada noted 
that the WTO Committee on Agriculture meeting could indeed be a more appropriate forum for the issue. 
C. 
EXCHANGE OF EXPERIENCES  
1. Good Regulatory Practice   
(i) Fifth Triennial Review follow-up: National processes and procedures 
284. The Chairman  drew the Committee's attention to the relevant recommendation from the 
Committee's Fifth Triennial Review cont ained in paragraph 11 of G/TBT/26. 
285. The representative of Mexico  agreed with other Members on the importance of making 
headway as quickly as possible on the implementation of recommendations contained in the 
Committee's Fifth Triennial Review Report.  He r ecalled that various Members, including Mexico, 
had made specific contributions  on GRP – including a joint communication from Canada, Mexico and 
the United States.7  The representative of Mexico asked the Secretariat to prepare a document on GRP 
on the basis of which the Committee could hold further discussions. 
286. The Chairman  emphasized the importance of indicating to  the Secretariat what relevant work 
needs to be listed.  He also suggested holding consu ltations with interested parties so as to consider 
how to take work forward. 
287. The representative of the European Union  reaffirmed his delegation's interest in cooperating 
actively to forward the Committee's recommendations in the area of good regulatory practice.  In respect of the work that the Co mmittee was expected to undertake under paragraph 11(a) of the Fifth 
Triennial Review (G/TBT/26), it was the EU unde rstanding that this work essentially comprised two 
stages. The first was about taking stock of existi ng guidelines and existing experiences, which meant 
drawing from Members own experiences as well as t hose carried out by international organizations.  
This was essentially a mapping or stocktaking exerci se.  The second stage would entail the assessment 
of this work with a view to determining wh ether there were some common elements on which 
agreement can be found in the TBT Committee.  Th ese common elements would be those, which, in 
principle, all WTO Members could apply to their regulatory process.  Hence, the work ahead would 
be one of seeking consensus in the TBT Committ ee on some basic elements of good regulatory 
practice that could serve to guide all Members.  Fo r efficiency, it could be useful for the Committee to 
explore a more flexible structure for its work , for instance through the establishment of ad hoc 
working groups, or other structure in which all interested parties could actively participate. 
288. The representatives of Mexico
 and El Salvador  expressed some hesitation about setting up a 
working party or a group separate from the Committ ee as this might limit participation to those 
Members with the resources to participate – and these would then be the ones to set the agenda of the 
debate.  The representative of Mexico noted that another workshop could be a better approach.  In 
such an event, Members could look more closely at, for instance, experiences with equivalence – in 
this respect the TBT Committee may want to cons ider hearing of the experience in the SPS area 
where guidelines had been developed. 
289. The representative of Chile  also wished to participate in any discussion on GRP.  Chile 
agreed that setting up an ad hoc group could be one way of approaching the issues; modern technology could be used to avoid the problem of resources mentioned by Mexico.   He noted that 
                                                     
 
7 The joint communication is contained in G/TBT/W/317, dated 15 June 2009.  References to other 
submissions relevant to Good Regulatory Practice are contained on pp. 19-20 of G/TBT/26.   G/TBT/M/51  
 Page 63 
 
 
  Chile had an internal handbook on Good Regulatory Practices that could be a contribution to the 
discussion.  
290. The representative of Colombia  emphasized the importance of considering risk assessment 
studies in the context of good regulatory practice, and finding ways of sharing Members' experiences. 
In this regard, including through the internet. 
291. The representative of Georgia  noted that her delegation was in  the process of elaborating and 
aligning its regulatory system; in this regard it wa s very important to know the various approaches 
used by Members – in this regard the deve lopment of "best practices" could be useful. 
292. The representative of the Secretariat  said that there might be scope  for listing existing relevant 
work; in this regard it would be useful for Members to indicate to the Secretar iat what they considered 
to be the most relevant information.  
293. The Chairman  emphasized that there were two steps ahead: first compilation of existing work 
and second, the identification of common elements.  He proposed that the Committee take it one step 
at a time.  It was important the Members digested available information.  As work moved on Members would get more involved and the process would become more evident. 
(ii) Workshop on Regulatory Cooperation between Members 
294. The Chairman
 recalled that the Committee had agreed to hold a workshop on regulatory 
cooperation between Members (paragraph 16 of G/TBT/ 26) and that this meeting was scheduled to be 
held back-to-back with the Committee's March 2011 regular meeting.  He noted that provision had 
been made in the WTO's 2010 Technical Assistance and Training Plan to assist participation of capital based officials from developing country Members.
8   
295. The representative of the United States  noted that APEC member economies were currently 
working to update several APEC documents on GR P, inducing some guidelines for drafting technical 
regulations and information notes on good practice fo r technical regulation – it was his understanding 
that the revisions would be completed by early 2011.  Since the documents were originally drafted, in 
1995 and 2000, the intention was to update them b ased on work undertaken over the last decade; in 
fact, there would be, in March 2011, a worksh op in the United States among APEC member 
economies on good regulatory practice to finalize th ese documents.  This could provide input to the 
WTO's workshop in March.  In addition, the repre sentative of the United States noted that the United 
States was involved in a number of other efforts on good regulatory practice. More specifically in terms of trying to enhance regulatory cooperation there was one forum between the United States and 
the European Union: a high level regulatory coop eration forum where the two governments discussed 
many issues.  There was also a newly formed regul atory cooperation council where efforts were being 
undertaken with Mexico, and hopefully Canada w ould join as well.  These efforts could also be 
considered in the upcoming WTO workshop. 
296. The representative of the European Union
 underscored the points made by the United States 
on the EU-US cooperation activities noting that this could form part of a joint presentation; the 
European Union would reflect on other possible inputs for the workshop, as well as on its structure. 
297. The representative of Chile  supported Mexico, regarding the workshop programme, on the 
usefulness of considering equivalence as  a form of regulatory cooperation. 
                                                      
8 WT/COMTD/W/170/Rev.1, p. 53. G/TBT/M/51    
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  298. The representative of Brazil
 recalled that in 2008, Brazil had presented in the TBT Committee 
its recently adopted guide of good regulatory pr actice which was a milestone in or regulatory 
framework because although it was a voluntary guid e it was supported by regulatory agencies in 
Brazil.  There was also now some accumulated experience in implementing the guide among regulatory agencies that could be shared among Member s; this related also to regulatory cooperation. 
299. The representative of St. Lucia
 stressed the importance of addressing issues related to 
implementation at the workshop. 
300. The Chairman  noted that to prepare a draft programme, it would be useful if Members came 
forwards with proposals, even initial ideas.  He ask ed delegations to provide any such proposals by 22 
July so that the Secretariat could circulate a draft programme after the August break.   
2. Conformity Assessment Procedures 
301. The Chairman  drew the Committee's attention to the relevant recommendation from the 
Committee's Fifth Triennial Review contained in para graph 19 of G/TBT/26.  He recalled that, at the 
last meeting, the representative of the European Union had given a presentation on its Framework for 
Accreditation (JOB/TBT/2).  
302. The representative of New Zealand  expressed particular interest in the work programme 
agreed in Paragraph 19(c) of the Fifth Triennial Review Report which referr ed to initiating work on 
developing practical guidelines.  In her view, any guidance needed to cover the full spectrum of 
options, from unilateral acceptance mechanisms, th rough to mutual recognition agreements (MRAs), 
as well as equivalence agreements.  Such guidance needed to be based on Members' experiences; it 
was important, she said, for Members to share such experiences in written submissions and 
presentations.  New Zealand had begun to compile a li st of papers submitted to the TBT Committee as 
a starting point – nine such papers had been identifie d to date.  This could be fleshed out with papers 
from other fora, such as the OECD workshops.  A document – a starting point – would be prepared for the November Committee meeting.  New Zeala nd expressed support for the idea to hold informal 
meetings, in addition to the regular Co mmittee meetings, to progress the work.   
3. Transparency 
303. The Chairman
 reported on the Committee's Sixth Sp ecial Meeting on Procedures for 
Information Exchange (see Annex 2 of this document). 
304. The representative of the United States  referred to the Special Meetings' last panel session, on 
transparency in standard setting.  He stressed the importance of the debate between the private sector 
standards bodies about how these bodies met the principles contained in TBT Committee's Decision 
on the development of international standards.  It  was interesting, he said, how standards bodies had 
reacted to these principles: they were, in fact, competing to convince WTO Members about how open, 
transparent, consensus based, and development frie ndly their standard-setting process was.  It was the 
US view that this would lead to better quality sta ndards that met the needs of industry and regulators.  
It promoted innovation and encouraged greater participation in standard-setting work among 
developing countries – not just in voting, but also in actual participation in the development of the 
standard in technical committees.  The United St ates stressed the need to encourage continued 
adherence to the TBT Committee Decision in this regards. 
305. The representative of the European Union  stressed that in order to take advantage of the 
sharing of experiences on transparency it would be  necessary, as a second step, for the Committee to 
enter into a debate of more specific issues.  For instance, it could be interesting for the Committee to 
have a more in-depth discussion on difficulties Memb ers were encountering with the notification of  G/TBT/M/51  
 Page 65 
 
 
  legislation containing technical regulations which had not been adopted by the administration but 
rather by parliament; could, for instance, a syst em of "early warnings" be found even for these 
measures?  On the issue of the various databases,  the European Union was of the view that the 
Committee could look into developing one database together, rather than all Member developing their 
own databases with their own web portals.  The data base of the Secretariat (the TBT IMS) could be a 
first step in this regard – but it would need to be further developed.  For instance, it would be 
important that all the information (addenda, transla tions, final text) about one specific notification was 
available in one place. Finally, such a web-based application could also be used by Members to 
actually fill out the notification format itself.  
306. The representative of Pakistan  noted, with respect to standard-setting, the difficulties for 
developing countries to identify the relevant international standard-se tting organizations in relation to 
the TBT Agreement and the TBT Committee's Decision.   He drew the Committee's attention to the 
proposals being discussed in the Non-Agricultural Market Access (NAMA) negotiations where India 
had proposed the designation of certain specific bodies, such as the ISO, IEC, ITU and Codex.  Yet how would one deal with the fact that there were  everyday new innovations, technological shifts and 
that the development of any standard took years – was it realistic to iden tify just a few bodies and 
burden them with the task of making standards for everything ? Would it be better to devise other ways 
and means to encourage standardizing bodies to devel op relevant standards? It was important, also, to 
observe transparency in the setting of internati onal standards.  These were a number of important 
issues that needed to be discussed. 
307. The representative of Malawi
 stressed the need to revert to th e issue of transparency at future 
meetings of the Committee.  It was important that developing countries heard from other Members 
about how to deal with challenges related to th e implementation of the Agreement's transparency 
provisions, for instance the running of enquiry points. 
III. TECHNICAL COOPERATION ACTIVITIES   
308. The representative of Paraguay  informed the Committee that  there was a new agreement 
between Paraguay and the European Union which in cluded TBT matters.  He added that there was 
also a draft MERCUSOR – EU economic agreement. 
309. The representative from Codex updated the Committee on recent technical assistance 
activities carried out by FAO and WHO.9   
310. The Chairman drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities.10  
311. The Secretariat informed the Committee that an Advanced C ourse on the TBT Agreement had 
taken place from 14-25 June.  25 officials from devel oping countries, as well as LDCs, took part in 
this course.11   
                                                      
9 Further information on thes e projects can be found on 
http://www.codexalimentarius.net/web/index_en.jsp. 
10 G/TBT/GEN/102. 
11 The complete programme and presentations are available on the WTO website:  
www.wto.org/english/news_e/news10_e/tra_14jun10_e.htm. G/TBT/M/51    
Page 66  
 
  IV. UPDATING BY OBSERVERS  
A. I
NFORMATION FROM OBSERVERS  
312. The representative from ISO  highlighted the important role ISO developing country members 
played in identifying their technical assistance needs and delivery. The central position developing 
countries occupied in the new ISO strategic plan, he said, was evident from how ISO had allocated 
specific funds from its own resources, in add ition to donor support for use in this area.12 
313. The representative of the IEC  provided the Committee with an update on its recent activities 
in developing countries.13 
314. The representative of the UNECE  informed the Committee that the next session of the 
Working Party on Regulatory Cooperation and Standa rdization Policies (WP6) would be held from  
1-3 November 2010.  This session would include  two panel sessions on risk management in 
regulatory assistance and on interna tional cooperation in c onformity assessment.  She highlighted the 
importance of risk management in good regulator y practices and its increased use in a number of 
countries in the development and the implementation of  technical barriers to trade.  In addition, she 
informed the TBT Committee that the UNECE Secr etariat was willing to contribute and share its 
experience in promoting a common regulatory frame work in specific sectors.  She reminded the 
Committee that WP6 encouraged regulatory coope ration by promoting convergence of regulations 
and, in a broader sense, encouraged coop eration in implementing the regulations. 
315. The representative of Codex  provided the Committee with an update on its recent events and 
on-going work related to TBT.14  
B. APPLICATIONS FOR OBSERVER STATUS IN THE TBT  COMMITTEE  
316. The Chairman  brought the Committee's attention to the document G/TBT/GEN/2/Rev.1 
which contained the list of bodies who had applied for observership status in the Committee.   
317. The representative from South Africa  supported the application of the SADC (Southern 
African Development Community) and informed the Committee that SADC played an important role 
in the organization of technical regulations and standards in the southern African development 
community. 
318. The representatives of the United States  and the European Union  supported the application of 
the ITU for ad hoc observership status.  However they requested that the other applications be 
discussed at the next meeting of the Committee so as to have time to consu lt with experts back in 
capitals. 
319. The representative from Zambia  joined South Africa in support of SADC as an ad hoc 
observer to the Committee.  She reminded the Committ ee that their application had been submitted in 
early 2010 and had been made available as a room document in the March meeting of the Committee. 
320. The representatives from China  and Brazil  supported the application of  the ITU in view of the 
close links between the Organizations in the area  of standardization. The Representative of the 
Philippines  supported the application of the ITU and re minded the Committee that as the ITU was an 
intergovernmental organization, most WTO Me mbers were also members of the ITU. The 
                                                      
12 G/TBT/GEN/101. 
13 G/TBT/GEN/103. 
14 G/TBT/GEN/104.  G/TBT/M/51  
 Page 67 
 
 
  representative of Mexico also supported the application of the ITU as an ad hoc observer to the TBT 
Committee. 
321. The Committee agreed  to grant ad hoc observership status to the International 
Telecommunications Union (ITU).  Pending requests woul d be reverted to at the next regular meeting 
of the TBT Committee.   
V. DATE OF THE NEXT MEETING  
322. The next regular meeting of the TBT Co mmittee will take place on 3-4 November 2010 . 
_______________ 
 
 
 G/TBT/M/51    
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  ANNEX 1  
SUMMARY REPORT OF THE SIXTH SPECIAL MEETING ON  
PROCEDURES FOR INFORMATION EXCHANGE 
22 June 2010
 
 
Chairperson:  Mr. Amit Yadav (India)  
  1. Pursuant to its decision to hold, on a biennial b asis, "regular meetings of persons responsible 
for information exchange, including persons respons ible for enquiry points and notifications", the 
TBT Committee held its Sixth Special Meeting on Procedures for Information Exchange on 
22 June 2010.
1  The objective of the Special Meeting was to provide Members an opportunity to 
discuss, at a technical level, issues relating to info rmation exchange and to review the functioning of 
notification procedures and the operation of enquiry points.2   The Special Meeting was organized in 
four panel sessions dealing with (i) good practices in notification; (ii) electronic databases; 
(iii) operation of enquiry points; and (iv)  transparency in standard-setting.  
A. SESSION 1 – GOOD PRACTICES IN NOTIFICATION  
2. The moderator3 introduced the session on Good Practices in Notification. She recalled that in 
the Fifth Triennial Review, Members had stressed the importance of transparency in processes and procedures used in the development and applica tion of technical regulations and conformity 
assessment procedures.  The session was intended to examine, inter alia , ways to facilitate internal 
coordination for the effective implementation of the TBT Agreement's notification obligations.   
1. Canada: Examples of 'good practices' to facilit ate internal coordination for the effective 
implementation of the TBT Agreement's notifications obligations
4 
3. The representative of Canada  outlined that in Canada, the Department of Foreign Affairs and 
International Trade retained ove rall responsibility for the coordina tion and implementation of all 
WTO Agreements. Since 1980, the Department has maintained an agreement with the Standards 
Council of Canada (SCC) for the operation of the national Notification Authority and the national 
Enquiry Point. SCC was responsible for fulfilling th e transparency obligations of the TBT, SPS and 
NAFTA agreements, distributing WTO notifi cations to Canadians through its service, Export Alert !, 
answering enquiries and providing information to foreign enquiry points on Canadian standards, 
technical regulations and conformity assessment proce dures.  It was noted that the federal regulatory 
process in Canada was structured so as to provide a consistent approach to making regulations across 
government while ensuring that the policy commitmen ts and legal obligations of the government of 
Canada were met. The structured process also ensure d predictability and transparency for Canadians, 
institutions, and businesses affected by the regulation.  For this, two mechanisms were employed: first 
the Triage Statement and then the Regulatory Impact Analysis Statement (RIAS). 
4. At the outset of regulatory development, regul atory organizations had to evaluate both a 
regulatory and a non-regulatory option, or decide whether to amend an existing regulation or to 
introduce a new regulation. When a regulatory orga nization had selected as its instrument choice to 
                                                      
1 The programme for the Special Meeti ng is contained in G/TBT/GEN/100. 
2 The participation of 96 representatives from deve loping country Members was supported through the 
WTO DDA Global Trust Fund. 
3 Moderator of the session was Ms Xueyan Guo, First Secretary at the Permanent Mission of China to 
the WTO, in charge of both TBT and SPS matters. 
4 Presentation made by Ms Andrea Spencer, Head  of the TBT/SPS Enquiry Point, SCC, Canada.  G/TBT/M/51  
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  amend or introduce a regulation, regulatory proposal s were assessed at an early stage to determine 
which processes could be streamlined and where r esources should be focused. This process was called 
"triaging". The assessment was achieved throu gh a Triage Statement which took into account 
available information regarding the expected level of impact of the regulatory proposal in ten key 
areas and assigned to each an expected impact of "low", "medium", or "high".  The responses to the 
triage questions enable the regulatory organization to initiate consultations, conduct detailed analysis 
on the regulatory proposal, and draft the RIAS commensurate with overall level of significance rating indicated by the Triage Statement of the regulatory proposal. A  key benefit derived from the triage 
process included the consistent approach to the Re gulatory Impact Analysis Statements across all 
federal regulatory organizations (e.g. the Nationa l Resource Council, Health Canada, etc.). Thus 
regardless of the regulatory orga nization, the same main elements are assessed and elaborated 
accordingly in the RIAS, which ensured predictabili ty and consistency of analysis for the enquiry 
point and for stakeholders. Furthermore, one of the 10 key areas that were assessed in the Triage 
Statement was the expected impact on Canada's  international obligations such as the WTO TBT 
Agreement.  
5. While the standard comment period was 30 da ys, a minimum of 75 days was required for 
measures which affected international trade (which  provided a window of 15 days for any activities 
relating to the review, preparation, submission a nd issuance of the notification to meet the 60 day 
comment period recommended by the WTO). All proposals were reviewed and assessed by the Canadian enquiry point and all regulatory proposal s that could have a significant impact on trade, 
including those based on international standards,  were notified to the TBT Secretariat.   
6. A second tool employed by Canada since nearly  25 years was the Regulatory Impact Analysis 
Statement (RIAS). When a government agency determ ined that a regulation was the best means for 
achieving an objective, it launched a process of pl anning and public consul tation, which involved 
identifying interested and affected parties and provid ing them with an opportunity to take part in open 
and meaningful discussions in all stages of the re gulatory process. Following the completion of a 
Triage Statement, the government agency prepared  its regulatory proposal along with a RIAS, which 
served as a public account of how the proposal followed each element of the federal regulatory policy and as a demonstration for the need of a regula tion. The RIAS allowed audiences to understand the 
government's intention, objectives and the expected im pact of the regulation. It also listed who would 
be affected, the consultations that had taken place to date, the views and comments of stakeholders, 
and how their comments had been addressed, the bene fits of the regulation and how the government 
intended to evaluate and measure  the regulation's performance agai nst its stated objective.  The 
regulatory proposals including the RIAS then were pre-published in the Canada Gazette , which gave 
an avenue to all interested parties to revi ew the regulation and provide further comments. 
7. In order to estimate the expected impact that a proposed measure may have on trade, 
particular attention was given to the executive summa ry, the issue, the objectives, the description, the 
cost/benefits analysis, the rationale, and the cons ultation parts of the RIAS. These elements assisted 
the enquiry point in determining whether an inte rnational standard existed, the impact of the 
regulation, the countries affected by it, and wh ether it fell under the SPS or the TBT agreement. A 
contact name was also provided at the end of th e regulation, which allowed the enquiry point to 
follow up with the regulator should additional info rmation be required. Once the decision had been 
reached to notify the proposal to the TBT Committee , every effort was made to follow the decisions 
and recommendations of the TBT Committee from G/TBT/1/Rev. 9, as well as from other Committee 
documents. Using the RIAS, the enquiry point produced a clear and descriptive outline of the regulatory proposal which allowed Members to gain an understanding of the government of Canada's 
regulatory intent in absence of the full text. 
8. The SCC served a coordination role in the receipt and transmission of comments. The 
regulatory department itself conducted a review of all comments while finalizing its regulation. The G/TBT/M/51    
Page 70  
 
  final regulation or conformity assessme nt procedure was published in the Canada Gazette , Part II, 
with an updated RIAS that included a summary of comments received during the pre-publication process and an explanation of how they were take n into account. If no comments were received this 
would also be stated in the regulation.  Part II of the Canada Gazette  was reviewed by the Enquiry 
point to identify adopted regulations to be notif ied to the WTO. The updated RIAS provided key 
information to this end, including the date of pre- publication which allowed for cross reference to the 
original draft measure. Copies of the adopted text  were also sent to Members who had submitted 
comments. 
9. In response to questions raised during the discussion, the representative of Canada
 informed 
delegations that the Triage Statement of a regulat ory proposal was not published, as it was an internal 
regulatory tool of the Canadian government. She conf irmed that elements of the RIAS were reflected 
in propositions for regulatory texts and that the regulatory body that had put forward the proposal also 
carried out the necessary analysis for the RIAS in consultation with an overseeing body of the Federal 
Government. She further clarified that key areas in  the Triage Statement that had been assessed to 
have an expected "high" impact thereafter underwen t a lengthier and more detailed analysis for the 
RIAS than areas that had been assessed as only havi ng a "low" impact. Regarding the number of 
notifications submitted per Member, she was of th e view that, among other things, this depended on 
the regulatory activity of countries and the frequency of their publications – Canada, for example, 
published its regulatory proposals on a weekly basis, whereas the United States had daily publications. 
2. The European Union's efforts to facilitate access for third countries to European Union 
notifications
5 
10. The representative of the European Union  stated that the Enquiry  Point advised services 
involved in legislative activities to include references  to international standards in a notification form 
when issuing a draft measure, and to allow for a co mment period of 60 or 90 days. The Enquiry Point 
made all draft measures available on its website, and all notifications  to the WTO contained a link to 
this website in order to disseminate the full text to other Members without delays. Draft proposals for 
the Commission usually were usually available in only one language, which usually was English and 
sometimes French. Draft proposals fo r the Parliament or for the Council were always available in all 
languages of the European Union, so links to the E nglish, French and Spanis h versions were provided 
in the WTO notification. 
11. The European Union itself regularly translated  the draft measure of other Members. These 
translations were published on its website and submitted to the WTO so that they could be forwarded 
to interested Members as a supplement to the orig inal notification.  When submitting a notification, 
the European Union always included a comprehensive description of the content of the text in Box 6 
of the notification format in order to provide othe r Members with a complete overview so that they 
could assess whether they could be interested in transl ating the full text of the measure for themselves 
(if it was not in an official language of the WT O).  The European Union felt that comprehensive 
descriptions reduced the occurrence of follow-up queries for clarification by other Members. 
12. The representative of the European Union noted  that when notifying an amendment of an 
earlier text, the European Union always provided a link to the earlier text on the notification format and also included a link to an impact assessment if one had taken place. Amendments to adopted 
measures were notified as new notif ications, amendments to draft measures that had not yet bee 
adopted were notified as addenda, and replacements of measures that had not been adopted were 
notified as revisions. Finally, supplementary informa tion, such as guidelines, fees, or extensions of 
                                                     
 
5 Presentation made by Ms Patricia McGinley, Coor dinator in the European Union TBT Enquiry Point 
in the Enterprises and Industry Dir ectorate of the European Commission.  G/TBT/M/51  
 Page 71 
 
 
  time periods were notified as addenda. Due to the different types of information categorized as 
"addenda", the European Union was not in favour of notifying amendments to adopted texts as addenda. For example, the European Union had to date notified 65 ame ndments to the Council 
Directive 91.4.14. If these amendments had been notified as addenda, perhaps their significance 
would have been evaluated differently by other Me mbers. Finally, she explained that the European 
Union notified adopted texts as addenda to prior not ifications.  She noted that comments from other 
Members were forwarded immediately to the pe rson responsible for the draft measure. Then a 
comprehensive and detailed writte n response was always produced , which could involve several 
different services of the Commission that were involved in the regulation. All comments and responses were published on the Commission's website. 
13. In response to questions raised during the di scussions, the representative of the European 
Union  delegation explained that member States had th e right to adopt their own individual technical 
regulations and conformity assessment procedures fo r product groups where the legislation had not 
been harmonized within the European Union. In these cases, the European Un ion advised Members to 
follow principles that in fact resembled those laid out in the TBT Agreement in order to enable the 
free flow of goods in the European internal mark et. Proposals for legislation were notified to the 
European Commission and to all other member States,  which also was similar to the practice of the 
WTO in administrating the TBT Agreement. The Eu ropean Union delegation also informed that 
translations of draft measures of other WTO Memb ers were done in-house by staff of the European 
Commission, if these measures were in one of the languages of the European Union, otherwise they 
were outsourced to external translators. Finally, on  a question about the large number of notifications 
– the representative of the European Union suggested  tat a possible explanation for the large number 
of notifications from developing country Members mi ght be explained by the fact that developed 
countries already had extensive legislations in pla ce, while developing countries were still in the 
process of developing such legislations. 
3. United States: Practices in WTO TBT Notifications6 
14. The representative of the United States  explained that all proposed and final rules by any 
United States federal government in stitution were published daily in th e journal "Federal Register" (in 
print and electronically), which was used by the three employees of the United States enquiry point as 
single source for all potential WTO TBT notificati ons. She noted that in this journal, comments 
received by other Members were only published toge ther with responses alongside a "Final Rule". 
Regarding technical regulations at the sub-central  government level, a commercially available daily 
aggregation of regulations by the 50 States in a database format was filtered electronically and 
manually for issues relevant to international commerce.  
15. It was emphasized that the United States attempted to notify all issues that had a significant 
impact on trade, regardless of whether or not the proposed rules were based on international 
standards. Since the rule making process involve d a lengthy chain of events and activities, 
notifications were often supplemented by addenda, corrigenda and revisions over time. The Enquiry 
Point had produced for its own use a lengthy docu ment detailing how to notify, how to process an 
addendum, corrigendum, or revision, and how to ask  for an extension of a comment period. All 
notifications to the WTO were also transmitted to  the United States SPS enquiry point, to the NAFTA 
partners (Canada and Mexico) and to 13 other na tions with whom the United States had free trade 
bilateral agreements.  Moreover, the United Stat es Enquiry Point made a monthly report of all 
activities, including on comments, all notificati ons, addenda, corrigenda, re visions and requests for 
extension of comment periods, as well as a list of all open requests that still needed to be addressed. 
                                                      
6 Presentation by Ms Anne Meininger, Team L eader of the United Stat es Enquiry Point and 
Notification Authority at the US National Institute of Standards and Technology (NIST). G/TBT/M/51    
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  16. In response to questions raised during the di scussions, the representative of the United States
 
informed the Committee that the monthly report of activities was an internal US government 
document that was not published. Regarding proposals discussed in the US Congress, it was noted that these posed particular challenges with rega rds to their notification to the WTO, as often 
individual proposed measures had multiple origins,  and oftentimes different proposals would be 
changed or were frequently merged, so that it was difficult to evaluate which ones would go forward 
and which ones should be notified to the WTO. The US  enquiry point did not translate draft measures 
of other Members itself; instead, it relied on transl ations provided by industr y. As these translations 
were proprietary, the United States generally did not forward them to the WTO, however the United States could ask its providers for permission on a case-by-case basis, if requested to do so by other 
Members. The US delegation noted that written r esponses were prepared for all comments, which 
explained how these comments had been taken into  account and whether or not they had led to 
changes in the legislation.  
17. In concluding, the moderator
 recalled that in the report of the 5th Triennial Review of the TBT 
Committee, the Committee had recommended the establishment of common procedures on how and 
under which format to notify modifications or any ot her information relevant to previously notified 
measures. In her view, this particular point c ould warrant further discussions in the Committee. 
B. SESSION 2 – ELECTRONIC DATABASES   
18. The moderator7 introduced the session, which was aimed at sharing experiences on how the 
use of electronic tools and web-based applications can enhance transparency and access to 
notifications.  He noted that over recent years WT O Members had taken advantage of the significant 
development in electronic tools and web-based app lications.  He said that the presentations would 
demonstrate how this had led to improved tr ansparency on TBT-related measures.   
1. The Chilean Technical Regulation Portal8 
19. The representative of Chile  spoke about her country's decision on the necessity to establish a 
portal for the public availability of  technical regulations and confor mity assessment procedures.9  She 
said that the accessibility of this universe of regula tions, in addition to other TBT-related information, 
exemplified how well Chile's agencies had coordina ted their knowledge and improved the availability 
of information through the internet.  Of priori ty was providing a foundation of common understanding 
between Ministries, with an undertaking to ensure that information was current and maintained up-to-
date.  She said that Chile's ai m was to meet transpar ency requirements through the portal; encourage 
the development of regulations; and provide an opportunity for public consultation. 
20. The representative of Chile went on to note th at much progress had been achieved since the 
establishment of the portal in 2007.  In performi ng their coordinating role to strengthen markets 
through the provision of consistency in technical regulations and conformity assessment, they aimed 
to ensure that regulations were properly impl emented under their obliga tions.  Major challenges 
remained, notably the development of internal coor dination, through training, to enhance awareness 
and skills.  Improved transparency, reflective of good regulatory practice, had also been identified as a 
key for future advancement.   
21. The representative of Korea  sought clarification on how Chile decided on the nature of the 
regulations to be included in their portal.  He used the example of one WTO Member's portal that 
                                                      
7 This session was moderated by Mr Juan Antonio Dorantes Sánchez, Mexico.  
8 Presentation by Ms Carolina Ramírez Joignant, TBT E nquiry Point, Department of Foreign Trade at 
the Ministry of the Economy of Chile, Chile. 
9 www.reglamentostecnicos.cl/.  G/TBT/M/51  
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  covered all regulations by the central government.  However in Chile's case the portal covered only 
technical regulations.   
22. The representative of Chile  replied that the technical regulation universe was complex, 
requiring the involvement of all ministries responsible  for the development of technical regulations, as 
well as the private sector.  Meetings were held to discuss each regulation, ta king into consideration 
the broader universal context, and bearing in mi nd that the filtering process required joint analysis 
with the corresponding regulator.  She said the task was not an easy one, with each analysis requiring 
at least two to three reviews prior to defining a technical regulation's classification.  A further time-
intensive updating stage follows.  After notifications  had been submitted to the WTO Secretariat they 
were tabled for official gazette publication.  De pending on the quantity of regulating agencies, there 
were some 12 agencies in Chile; this process could take a number of years. 
23. The representative of Uganda  queried whether updates were undertaken by regulatory 
agencies and whether or not they were centralized.   
24. The representative of Chile said that, with resp ect to data capture and updating, they were 
both centralized and decentralized.  Their approach  was that each focal point within a regulating 
agency, from different ministries, relied on both.  Once a technical regulation was published in the 
official gazette, the regulating agen cy informed them of the necessity for inclusion in the portal.  The 
format was authorized by the corresponding agency.   
2. China's Experiences in Information Processing10 
25. The representative of China  described her country's experiences in information processing.  
She said that China had established a TBT/SPS notifi cation database and enquiry network to facilitate 
information exchange and management.11  Supported by 220 databases with links to relevant 
websites, the network provided access to notifi cations; technical regulations; standards; 
complementary assessment procedures; market access,  etc.  The search engine provides key word 
criteria options such as notification number, date or title and HS code.  She in formed delegations that 
TBT notifications had been available in Chinese a nd English since 2001, highlighting that the Chinese 
and English language versi ons of their database were not the sa me.  Free public access provided risk 
alerts on certain laws, both domestic and internatio nal, and timely availability assisted manufacturers 
from product recall in importing countries. 
26. The representative of China noted that statisti cal analysis of the website and notification 
database was undertaken, from which analysis re ports could be generated by users - providing 
information on the number of notifications, notific ation type, notifying Member, products covered, 
objectives and rationale.    
27. The representative of the European Union  queried whether China had encountered problems 
on the differentiation between new notifications a nd addenda.  For instance, some Members notified 
amendments to adopted texts through an adden dum, rather than a new notification.  The EU 
representative asked whether the Chinese database en countered the same problem, and if a resolution 
had been found. 
28. The representative of China  replied that their website distinguished new notifications from 
addenda (to old ones).  She recommended the WTO TBT Information Management System as it 
included new notifications, addenda and corrigenda, a nd was easy to use.  She said that in hindsight 
some applications would have been developed diffe rently, for example an on line subscription service.  
                                                      
10 Presentation by Dr. Xu Zhanju, China WTO/TBT Enquiry Point, China. 
11 www.tbt-sps.gov.cn/Pages/home.aspx. G/TBT/M/51    
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  3. The EU Electronic Tools: A more efficient management and better circulation of TBT 
notifications
12 
29. The representative of the European Union  noted how the number of WTO TBT notifications 
had doubled in less than five years; this entailed a challenge to create an IT management application.  
It was now available through the multilingual Euro pean Commission Enterprise and Industry TBT 
website.13  Since inception in 2004, some 50,000 sear ches had been performed each year.  Upon 
receipt of TBT notifications the automated procedure extracted relevant data.  It provided added value 
as it was an effective timesaving tool; it served as a basis for research criteria for economic upgrading 
for internal services; it provided a clear overview of  each notification; and, it facilitated follow-up.  
The public website provided users with a single screen overall view of each notification; search 
facilities; access to online library; monthly summari es; email subscription; useful website links; 
contact and comment options.   
30. The representative of the European Union noted  that the usefulness of the EU site was 
dependent upon effective communication with minist ries, enterprises and external operators.  The 
database allowed for identification of notifications requiring development or submission to the WTO.  
The internal warning service advised designated co lleagues of incoming notifications that could 
require analysis.  Mindful of the value of improving their web services, the EU had anticipated a new notification system in the more stable portable document format (pdf).   
31. The representative of Malawi
 noted that the EU offered public access through a separate 
portal and queried whether this had resulted in a loss of relevant, timely information.  He also asked 
whether Malawi, as a developing country, could gain detailed advice on developing its own IT 
system. 
32. The representative of the European Union  replied that the public site provided equivalent 
information to the management application.  Ho wever, the management application provided the 
additional facility of an internal follow-up mechan ism, as well as documents emanating from industry 
whose views did not necessarily represent those of the Commission. 
4. The Indian experience on the Development of online TBT portal by Centre for WTO 
Studies14 
33. The representative of India  said that the Centre for WTO Studies15 had been established in 
2002 with the main objectives of providing independent research and analytical support to 
Government; disseminating information on trade-rela ted issues; and performing outreach and capacity 
building programmes.  The portal serviced exporters  and policy makers, enabling them to examine 
market access opportunities through a consolidated si te.  The previous incapacity to capture combined 
information on non-tariff measures; the imperative to  look beyond tariffs; and the necessity to link 
WTO Member notifications with HS codes had b een the driving force to create a comprehensive 
database capable of disseminating timely informat ion.  The process had taken six years and now 
hosted all WTO TBT and SPS notifications (to March 2010) with HS nomenclature.  Currently their 
portal offered free registration to applicants, without restriction as to the number of registrations per 
organization.   
34. In establishing the portal, the Centre encountered  a number of practical problems, for instance 
the lack of HS codes in TBT notifications.  Th is had a knock-on effect as an importing country's 
                                                      
12 Presentation by Mr. Cyril Hanquez, European Comission. 
13 http://ec.europa.eu/enterprise/tbt/index.cfm?dspLang=en. 
14 Presentation by Professor Rajan Sudesh Ratna, Ce ntre for WTO Studies, IIFT, New Delhi, India. 
15 http://wtocentre.iift.ac.in/.  G/TBT/M/51  
 Page 75 
 
 
  customs agency oftentimes decided upon the product cl assification at the time of import.  This, in 
turn, could result in additional fees, the need for re -classification and time delays for the exporter.  
Additionally, he noted that there were repetitive notification submissions to the WTO for the same 
standard or regulation, due to addenda or modifi cations.  This highlighted the need for raising 
Members awareness and WTO Secretariat technical assistance.  Although language was an additional 
challenge, the representative of India noted that that the US website was particularly helpful due to the 
availability of English translations.  In respect of the challenges mentioned, he said that the WTO 
TBT data management system could contribute to addressing them. 
35. The representative of Mauritius  asked whether the Indian database provided information on 
streamlining of measures on a particular HS code or product, with regard the compilation of NTM 
identification and including SPS activity. 
36. The representative of India  replied that because database had been developed on the basis of 
notifications from WTO Members, how those me asures could be streamlined had not been 
considered.  For instance, if a query on an HS line per country was made, the system would list the 
number of notifications per HS line, per country.  
37. The representative of Mexico  voiced concern that although the website provided free access 
at present, in the future there could be restrictions or user costs.  
38. The representative of India  confirmed that at this point in time the portal was freely available.  
He anticipated that this would continue, as the purp ose of developing the website had been to assist 
Indian exporters.  Additionally, he represented an ac ademic institution that had promoted their portal 
to researchers working on the areas of TBT and SPS, for whom obtaining information from one major 
source was relevant.   
5. Information System on Notification – Indonesia's Experience16 
39. The representative of Indonesia  said that the National Standardization Agency of Indonesia 
(BSN) had, since 1995, been the appointed Enquiry  Point and Notification Body accountable for the 
implementation of the WTO TBT Agreement.  He said that BSN was responsible for handling all 
notifications and related enquiries and for the de velopment and maintenanc e of cooperation with 
stakeholders.  Incoming notifications were mon itored and distributed amongst related technical 
bodies; working groups were established with regul ators and industry; and coordination meetings 
were conducted with stakeholders for review and analysis.  Outgoi ng notifications were likewise 
subject to monitoring and analysis.  He noted that  all draft technical regulations were analyzed and 
reviewed and then notified to the WTO Central Registry of Notifications (CRN). 
40. The BSN database allowed for submission of online enquiries from domestic and foreign 
stakeholders.  Recently Indonesia had establis hed a TBT information system which included 
Indonesian notifications, incoming notifications from WTO Members, and a list of technical 
regulations.17  The online system indicated to an enquirer  the timetable for the technical regulation 
(for instance, green for 15 days, yellow for seven, re d for deadline expiry), and enabled downloading 
of documentation.  BSN had an action plan to undertake improving the information system based on 
stakeholder reviews; improved promotion to stakeh olders as well as traders; and the establishment of 
an alert system according to product and destination.   
                                                      
16 Presentation by Mr I. Nyoman Supriyatna, National Standardization Agency of Indonesia, BSN TBT 
WTO Notification and Enquiry Point, Indonesia. 
17 http://tbt.bsn.go.id/index.php/notif/usulan/pub/en. G/TBT/M/51    
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  6. Electronic Databases in the USA WTO TBT Enquiry Point: "Notify US"
18 
41. The representative of the United States  presented the USA Enquiry Point electronic database 
Notify US19, developed at the National Institute of St andards and Technology (NIST).  Launched in 
2005, she said it was an integration of three modules:  a data processing component which captured 
WTO TBT notifications; an administrative component  which allowed the Enquiry Point to manage 
registered users and enabled running of reports and statistics; and a public website user interface that 
facilitated registered users to access Notify US.  Over the last five years some 5,000 users had 
registered, representing some 3,000 individual bus inesses and 50 WTO Members (the system had 
been opened for the use of all WTO TBT Enquiry Points).  In 2009 alone, some 63,000 TBT 
information items had been delivered, a challenge that could not have been overcome with a manual 
system.  An additional website, allowing access to all US notifications in one place, would soon be 
publicly available.   
42. The target users for Notify US were national business and industry (as well as other domestic 
global trade stakeholders); these were the driving forces that had led to the development of the 
application.  It provided the opportunity to im prove federal government outreach, in collaboration 
with national industry.  Through user customized pa ges, Notify US allowed for access to full texts and 
extensive WTO TBT-related information; provided  deadlines for comment, advised on how to submit 
effective comments and requests for deadline extens ions.  The application also provided an early 
warning system to US exporters on changing standa rds and technical regulations used in the global 
market.  Trade stakeholders were immediatel y informed about changing conditions; had the 
opportunity to comment and potentially influence the outcome; and were given assistance on global 
trade issues. 
43. The representative of Argentina  said that in their attempt to  subscribe to Notify US, the 
system advised that it was only available to subscr ibers who were US citizens and individuals that 
were part of US-based organizations and industri es.  The representative requested modification to 
facilitate outside government agencies.   
44. The representative of the United States  replied that they had restricted use to US parties.  
However, an exception had been made for WTO Enquiry Points.  Further, Notify US was debating whether the application should be made available to a wider audience.   
45. The representative of Jordan
 asked how Notify US determined the methodology used to 
inform stakeholders about global changes and how exactly the action was performed. 
46. The representative of the United States  said that Notify US classified incoming notifications 
by the International Classification of Standards (ICS) code industry sectors.  Users of the system 
identified their preferences within their online prof iles.  A sorting was then undertaken, matching the 
user with the notification through the ICS code  industry sectors.  An email to the user was 
automatically generated.  She noted that many e xperienced users were not reliant on Notify US email 
notification, preferring instead to check the system daily. 
                                                      
18 Presentation by Ms Anne Meininger, Team Lead er of the US Enquiry Point and Notification 
Authority, United States. 
19 https://tsapps.nist.gov/notif yus/data/index/index.cfm.  G/TBT/M/51  
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  7. The WTO TBT Informatio n Management System20 
47. The representative of the WTO Secretariat presented the TBT Information Management 
System (IMS)21, an online source for searching and cust om-reporting TBT-relate d information.  
Launched in 2009, it allowed for Members and inte rested parties to track TBT information.  He 
informed the Committee that from 1995 to date, TB T notifications totaled some 14,000.  The online 
interface facilitated the task of the Secretariat in the timely provision of a high volume of 
notifications, as well as up-to-date information on Enqui ry Points.  Searches for notifications could be 
done by document symbol, date of distribution, different products, HS codes up to the 6th digit level,  
and comment deadlines.  Incoming notifications to th e Central Registry of Notifications (CRN) were 
allocated any of the 45 notificati on key words, such as animal feed or biofuels.  Custom reporting was 
available and allowed users to create a table formul ated by different criteria that could be exported 
into Excel.  The representative of the Secretariat  also informed Members about a new feature on 
information related to specific trade concerns (STCs).   
48. The representative of Uganda  stated that they used the IM S system in their day-to-day 
running of their National Enquiry Point for TBT.   He queried whether it was possible to make 
modifications for search criteria, as they were unable to retrieve all Member notifications through the 
notifying Member search.  
49. The representative of the Secretariat  replied that leaving the "Member" search option blank 
would enable all Members notifications to appear.  He further stated that the Secretariat would raise 
the issue with their IT team to see whether it woul d be possible to incorporate a clearer search option 
to retrieve all Member notifications. 
50. The representative of Switzerland  recalled that at the Fifth Triennial Review the Committee 
had recommended the feasibility of utilizing the TBT IMS for comments and replies on notifications.  
He inquired about the feasibility of such an exerci se. Moreover, as the numbers of notifications were 
ever-increasing, he suggested that the WTO Secretar iat could inform private users of their ability to 
sign up to the TBT IMS, therefore negating the need for Members to distribute the notifications 
themselves: this would mean that the informati on could be channeled directly through the WTO 
website rather than individual Members' national websites.   
51.  The Secretariat  responded that they were aware of the growing trend for using websites as for 
discussions, including with respect to notificati ons.  Considering the mentioned recommendation from 
the Triennial Review, the Secretariat would consider  its current scope of IT capabilities.  Meanwhile, 
it was not possible to make online comments on individual notifications on the WTO TBT IMS. 
52. The moderator  concluded that the presentations had illustrated how the use of electronic tools 
was indeed making implementation of the TBT Agreem ent's transparency provisions more effective.  
In fact, the development as such of these tools helped Members in their own national coordination 
activities, between regulatory agencies and other stak eholders, including the private sector.  The same 
electronic tools enabled the Membership to better cap ture statistics and identify trade interests – and 
provided information between Members.  However, there were many challenges that needed to be 
overcome. For instance, the diversity of languages in  which technical regulations were written could 
inhibit efficiency when authorities in different c ountries sought to consult them. Also, Internet was 
not yet readily available everywhere.  In terms of technical assistance it was important for Members to 
share their experiences of IT development, be th ey from developed or developing countries.  He 
suggested that a better use of resources might be for the TBT IMS to provide links to all Members' 
websites that had information on TBT notifications and Enquiry Points. 
                                                      
20 Presentation by Mr. Pablo Jenkins, WTO Secretariat. 
21 http://tbtims.wto.org/. G/TBT/M/51    
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  C. 
SESSION 3 – OPERATION OF ENQUIRY POINTS  
53. The moderator22 opened the session by emphasizing the importance of well-functioning 
Enquiry Points as part of the TBT notification procedure.  She explained that the purpose of this session was to identify the challenges which Enquiry Po ints were facing and to envisage solutions to 
overcome them.   
1. Brazil: Promoting Awareness of TBT-Related Issues among Brazilian SMEs
23 
54. The representative of Brazil  presented the experience of the Brazilian National Institute of 
Metrology Standardization and I ndustrial Quality, referred to as IN METRO, in promoting awareness 
of TBT related issues among Brazilian companies, especially small and medium enterprises (SMEs) 
through activities on the scope of responsibility unde r the TBT Agreement and through an electronic 
tool known as "Export Alert".  
55. INMETRO had been responsible for enquiry po int functions concerning the TBT Agreement 
since 1995 while also conducting a number of other activities, including: scientific and industrial 
metrology; legal metrology; the authority to establis h technical regulation and conformity assessment 
procedures; accreditation of test laboratories and certification bodies; innovation and technology 
information; and biology, health and biotechnolog y.  The representative of Brazil recalled that the 
establishment of an enquiry point had been an im portant element in ensuring the transparency of 
information on technical regulations  being applied or prepared.  The principle of transparency had 
been extended, through Article 10 of the TBT Agre ement, to govern the application of technical 
regulations, standards and conformity assessment  procedures.  These provisions had the main 
objective of guaranteeing that mandatory regulations  were not formulated or applied by Members 
with the intention in creating unnecessary obstacles to trade. 
56. In Brazil, INMETRO provided information to local exporters through the operation of an 
electronic service of enquiries about foreign t echnical requirements called "Export Alert".  This 
service allowed exporters to gather the minimum in formation necessary to prepare an enquiry to a 
foreign TBT enquiry point.  Information availabl e included the classification of the product in the 
Harmonized System and a preliminary check of past notifications; some research was also possible by 
using key words.  Moreover, with a simple search it was possible to find the original notification, the 
complete text of the proposed technical regulati on, and a summary in Port uguese of the notification's 
content and the addendum form that contained the we bsite address where the adopted final text could 
be obtained. 
57. INMETRO had actively promoted this electronic facility through presentations, including 
around 200 appearances in 5 years at foreign trade fairs.   This had helped promote an export culture in 
Brazil, and raise awareness of INMETRO's TBT webs ite.  Additionally, through the distribution of 
registration forms at foreign trade fairs, INM ETRO had been able to increase the number of 
subscribers to "Export Alert".  The developmen t of publications and studies, done jointly with 
international organizations had helped raise the awareness of the TBT Agreement and "Export Alert" 
among exporters.  
58. The representative of Brazil concluded by presenting some statistics on the number of 
enquiries and subscribers to "Export Alert".  He expl ained that even with the global economic crisis, 
in 2010, "Export Alert" had reached 8000 subscribers.   
                                                      
22 This session was moderated by Meike Wolf, EU TB T Notification and Enquiry Point, Coordinator of 
TBT Issues, Directorate General Enterpri se and Industry, European Union.  
23 Presentation by Mr. Eduardo Trajano Gadret, INMETRO, Brazil.  G/TBT/M/51  
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  2. Paraguay: Operation and Challenges of the Paraguayan Enquiry Point of the TBT 
Agreement24 
59. The representative of Paraguay  presented his country's National System of Information and 
Notification of Technical Regulations, Standards and Procedures of Conformity Assessment (SNIN). 
Financed through an agreement with the European  Commission to promote Paraguayan exports, the 
system had been created in 2005 by Decree 6499.  By  2006, Paraguay had been able to comply with 
the notification requirements of the TBT Agreemen t.  And, in 2009, Paraguay created the National 
Technical Committee on Technical Barriers to Trade.  
60. It was noted that SNIN was composed of ten public regulatory bodies, including: the Ministry 
of Industry and Trade (general coordinator), Ministry  of Foreign Affairs (focal point), the Ministry of 
Agriculture, the National Service for Animal Health and Quality, the Ministry of Public Health, the 
National Food Institute.  The regulatory and notif ication procedures in Paraguay started with the 
regulatory bodies developing a draft technical regula tion.  Regulatory projects were then forwarded 
from the coordination unit of the regulatory bodies to  the plenary of SNIN and the National Technical 
Committee on Technical Barriers to Trade where it w ould be analysed and disseminated.  Finally it 
would be sent to the Ministry of Foreign Affairs who would notify it to the WTO. By 2010, Paraguay 
had submitted to the WTO Secretariat a total 32 notifi cations in conformity with Article 10.6 of the 
TBT Agreement.  
61. The process in Paraguay for receiving notifications by other WTO Members started with the 
coordination unit of SNIN who would analyze and di sseminate the text to the relevant regulatory 
entities, the private sector, the plenary of SNIN, and the National Technical Committee on Technical 
Barriers to Trade.   
62. The representative of Paraguay noted that SNIN regulatory agencies also followed a code of 
good practice when issuing new regulations.  Vari ous recommendations included notifying the WTO 
60 days before the implementation and following intern ational standards in the national legislation.  
Additionally, international cons ultations had been carried out to support the establishment and 
strategic positioning of the SNIN, to modernize th e information and notification system, to train 
exporters, and to improve technical  skills through training of the various staff Members of SNIN.  
63. Some of the various difficulties and challeng es faced by the Paraguay Enquiry Point were 
outlined.  First, translation of foreign notifica tions was time consumi ng and hindered Paraguay's 
ability to comment on planned technical regulati ons.  Paraguay often did not receive support from 
developed countries that had much greater capacity in this regard.  Second, notifications often did not 
follow the Harmonized System to identify the products  concerned, which made it difficult for industry 
in Paraguay to know whether they would be affected  by technical regulations or standards in another 
country.  Third, the Paraguay Enquiry Point needed  to improve its infrastructure and technology.  
Fourth, a scarcity of human resources (the enquiry point was comprised of only one director and 4 officials) had resulted in a strategy to distribut e the work to different agencies that had more 
capacities.  Fifth, training programs at the national and international level fo r SNIN officials were 
often ineffective, as Paraguay faced major probl ems in strengthening capacity, such as frequent 
changes of public authorities.  As a consequence,  important human resources were lost and no long-
term management c ould be provided.  
64. Additional challenges existed: for instance with  respect to the private sector's ability to 
comment on draft regulations.  In order to address this lack of technical capacity, the representative of 
Paraguay suggested organizational restructuring, in cluding adding staff for market surveillance.  
                                                     
 
24 Presentation by Mr. Ricardo Herreros Usher, Director  General of Foreign Trade at the Ministry of 
Industry and Commerce,  Foreign Trade Advisor to  the Secretary of Stat e for Trade, Paraguay. G/TBT/M/51    
Page 80  
 
  Furthermore, he stressed the need to improve the dissemination and communication of its official 
technical regulations.  He suggested that Paraguay could publish the projects of technical regulations 
in the official gazette (as is the practice in othe r countries), a process that would be faster than the 
current email and mail notifications.  This would in crease access to the relevant information as well as 
increase transparency.  
65. International cooperation was also important fo r Paraguay's Enquiry Point.  Cooperation with 
the European Union had continued after the establis hment of SNIN to secure the achievements with 
respect to the Enquiry Point.  At the regional le vel, Paraguay within MERCO SUR was participating in 
the working subgroup on technical regulations a nd conformity assessment procedures in which the 
regulations of MERCOSUR countries were harm onized.  He stressed that MERCOSUR had 294 
harmonized regulations which were common to all MERCOSUR members and which all had been 
notified to the WTO.  He concluded that despite the major challenges faced by the enquiry point in 
Paraguay, the SNIN was complying with all oblig ations of the TBT Agreement and was aiming to 
further improve its functioning.   
3. Turkey: Challenges Faced by the Turkish Enquiry Point
25 
66. The representative of Turkey  presented the challenges faced by the Turkish Enquiry Point.  In 
Turkey, the Secretariat of Foreign Trade served as  Enquiry Point while also facilitating consultation 
between regulatory agencies at the national level.  Since 2005, the Undersecretariat of Foreign Trade 
(UPF) had managed a web-based programme where users had been able to access instantly all 
notifications made by other WTO Members, based on enquiries from other National Enquiry Points.  
In addition to regulatory agencies, all relevant parties could gather information from this system.  
67. Regarding the process for enquiries and notifica tion in Turkey, the Enquiry Point received 
enquiries from both domestic stakeholders and from fo reign Enquiry Points a nd foreign exporters.  
Simple enquiries from domestic stakeholders were addressed by the Turkish Enquiry Point while 
more complex enquiries were sent to the relevant  foreign Enquiry Points.  Enquiries from foreign 
Enquiry Points were classified and recorded in the web-based programme run by the UPF so that 
responses could be coordinated.  If information wa s easily available a response was sent right away, 
otherwise help was sought from the agency responsi ble for the regulation.  The Enquiry Point also 
handled notifications.  All notifi cations published on the WTO website were complied and distributed 
to the relevant stakeholders in Turkey.  The En quiry Point would then coordinate and draft the 
comments related to concerns over the notifications.  
68. Challenges that the Turkish Enquiry Point faced  included: (i) National Enquiry Point's own 
operation, (ii) coordination of regulatory agencies,  (iii) customs union requirements, (iv) effective 
communication with other National Enquiry Points, (v ) domestic stakeholders' concerns, and (vi) the 
process of the TBT mechanism.  
69. With regards to the Turkish Enquiry Point's ow n operation, the representative of Turkey noted 
that the actual priorities inside the Turkish Enquiry Point were not always in line with TBT priorities 
and other trade concerns.  In addition, the En quiry Point preferred bilateral over multilateral 
processes; it was dealing with a heavy workload, w as facing an increasing number of notifications and 
was dogged with a lack of personnel and frequent ch anges in their positions.  The representative of 
Turkey questioned, given these challenges, whether combining enquiry and no tification functions was 
efficient.  He noted that TBT notifications had been rising rapidly, more than tripling over the past 15 
years. 
                                                      
25 Presentation by Mr. Tarik Gencosmanoglu, Senior Trade Expert, Undersecretariate for Foreign 
Trade, Turkey.   G/TBT/M/51  
 Page 81 
 
 
  70. With regards to challenges in coordinating Tu rkish regulatory agencies, the representative of 
Turkey explained that there existed a number of obstacles, for instance, agencies were not always 
aware or competent enough to know what and where a notification was required.  High turnover among employees made establishing institutional awaren ess difficult.  Furthermore, there was a faulty 
perception within the agencies that the TBT mechanism was not effective enough.  
71. Turkey had also been obliged to align its tec hnical legislation with the European Union, a 
complex process which created challenges for the Tu rkish Enquiry Point.  Uncertainties arose with 
regards to when notifications were required; this  was particularly the case when Turkey translated 
legislation on procedures within the EU harmoni zed area.  The representa tive of Turkey asked 
whether Turkey should notify regulations that were  already being put into force by the European 
Union.   
72.  The Turkish Enquiry Point also highlighted difficulties that existed in communicating with 
other countries' enquiry points.  In some cases, no confirmation of the receipt of enquiries was made, 
making it difficult to coordinate follow-ups.  Add itionally, sometimes domestic enquiries were not 
responded to and the full text of foreign tec hnical regulations were not made available. 
73. Domestic stakeholders also faced challenges w ith regards to the enquiry process.  Foreign 
texts received in languages other than WTO offici al languages created difficulties in examining and 
commenting on proposed regulations.  And incomplete  notification forms (i.e. lack of HS codes), 
created additional work for national Enquiry Points.  
74. Finally, the representative of Turkey outlined th e challenges his Enquiry Point faced with the 
TBT mechanism.  He explained that an increasing number of notifications had imposed a heavy 
workload on the TBT Committee.  As  a result, there was often not enough time to discuss specific 
trade concerns at the Committee meetings.  Additionally, fundamental problems emerged on 
differences between Members' interpretations of tec hnical issues.  The slow and drawn out nature of 
the process gave the impression to Turkish stakehol ders and the Turkish Enquiry Point that the TBT 
mechanism was limited in its usefulness.  
75. In conclusion it was suggested that: (i) a ll Members improve their coordination between 
National Enquiry Points, (ii) technical assistan ce become more effective and customized (i.e. 
differentiating between high level and technical levels), and (iii) TBT Committee meetings be 
extended from two to five days, as was the practice in the SPS Committee. 
76. During the questions, Malawi
 noted that they faced similar challenges as the Turkish Enquiry 
Point.  He stressed the importance of IT but noted  that internet access was not always possible in 
Malawi.  When disseminating notifications to stak eholders, the Malawi Enquiry Point often had to 
supplement them with hard copies.  Additional difficulties existed due to the high illiteracy rate 
among certain sectors.  
77. The moderator  concluded that the biggest challenge highlighted in the session was that of 
coordination: domestic coordination between regulator y agencies; coordination w ithin the agency that 
housed the Enquiry Point; and coordination with external stakeholders. Additional challenges 
included: the increasing number of TBT notifications , lack and variability of personnel within certain 
Enquiry Points, lack of IT infrastructure, language of  texts, and incomplete no tifications (in particular 
absence of HS codes). Solutions identified by Me mbers included the use of  databases to increase 
information availability and training of the Enqui ry Point personnel.  She concluded that such 
information exchanges should continue within the TBT Committee as well as on bilateral basis. G/TBT/M/51    
Page 82  
 
  D. 
SESSION 4 – TRANSPARENCY IN STANDARD SETTING  
78. The moderator26 opened the session by reminding delegates of discussions that had taken 
place during the Fifth Triennial Review on standards.  She also referred to the TBT Committee's Code 
of Good Practice and the Committee Decision on prin ciples for the development of international 
standards guides, and recommendations.   
1. Egypt's experience in Transparency in Standard Setting27 
79. The representative of Egypt  made a presentation on the steps followed so as to ensure 
transparency in standard-setting in Egypt.  She stre ssed that Egyptian standards were used to achieve 
increased productivity and improved product qua lity as well as consumer and environmental 
protection. Better communication and unders tanding of the process had led to increased 
competitiveness in the local and international markets. 
80. The representative of Egypt explained the pr ocedures for ensuring transparency in the 
establishment of a standard. These were:  setting up the st andards plan;  an initial study;  circulation of 
the draft standard for comment;  notification;  approval of the Egyptian Organization for 
Standardization (EOS) Council; and, finally, th e numbering, publishing and circulation of the 
standard.  The standards plan looked at the actual needs of stakeholders, this included the private 
sector, academics, government departments and cons umers.  The initial study was undertaken by a 
technical committee which then circulated the draf t standard to relevant bodies for review and 
comments within 60 days.  Egyptian standards were then published in the EOS magazine and on the 
EOS website.28  The representative of Egypt stressed that th e involvement of all stakeholders in the 
standard setting process was essential to tran sparency in the standard-setting process.  
81. In response to a question from the representative of Kenya  on how the technical committees 
ensured that their meetings were well attended by the private sector, the representative of Egypt 
explained that consumer trust was very important to the private sector industry in Egypt and therefore 
the consultation meetings were well attended by the chambers of commerce who represented the 
private sector companies.  
2. WTO criteria in European standard setting29  
82. The representative of the European Union  made a presentation on transparency in standard 
setting within the European Union.  He gave a brief introduction on CEN30 and CENELEC31, the 
bodies responsible for the development of standa rds in all sectors, excluding telecommunications, 
within the European Union.  He  said that these non-profit associations were made up of 31 National 
Standard Bodies or national committees – 27 were  EU member States, 3 from EFTA and one from 
Croatia.  He stressed that CEN and CENELEC  were the only European Standards Organisations 
(ESOs) recognized by EU institutions (together w ith ETSI – European Telecoms Standards Institute) 
as per Directive 98/34. 
83. The representative of the European Union e xplained that under the European Standards 
system, all national members were obliged to adopt a European Standard as a national standard and to 
                                                      
26 This session was moderated by Michelle Cooper, First Secretary at the Permanent Mission of Canada 
to the WTO.  
27 Ms Heba Hammad from the Egyptian Organization for Standardization (EOS). 
28 www.eos.org.eg. 
29 Georges Malcorps, European Commission [can anything else be said, title?]. 
30 European Committee fo r Standardization. 
31 European Committee for Electro technical Standardization.  G/TBT/M/51  
 Page 83 
 
 
  withdraw any conflicting pre-existi ng standard.  There were also 19  affiliates and various cooperation 
agreements globally.  He outlined the principl es of the organizations: consensus; openness and 
transparency;  national commitment (even if a member  had voted against the European Standard at the 
draft stage);  technical coherence at the national and European level; correct integration with other 
international work (with 70 per cent of CENELEC st andards identical to IEC standards);  market 
relevance and, finally, the WTO Code of Good Prac tice.  To ensure transparency the programme of 
work was available on the CEN and CENELEC webs ites. Consensus building took place in the 
technical bodies with national delegations designa ted by the national members of CEN.  These 
Committees were then mirrored at national levels so th at stakeholders could also participate.  During 
this process, the draft standard was distributed to CEN national members so that public enquiries 
could be carried out.  In a number of countries, th e draft standards could be accessed and reviewed on 
line.  The standard, when finalized, was published on the CEN website.32 
84. The representative of the European Union presente d the example of a recent  study relevant to 
SMEs which highlighted areas where improvements in transparency were necessary.  Fifty eight 
recommendations had been made laying down four  main objectives:  to increase awareness about 
standards and the related benefits; to improve access to  standards; to facilitate the use of standards, 
and to increase participation in standardization.  In order to achieve these objectives, an SME 
helpdesk with national contact points had been estab lished; the abstract of the standards and draft 
were made available on the website; an SME Standa rdization Toolkit and a guide had been prepared 
to help standard writers take into account th e needs of SMEs. Another initiative had been the 
establishment of a working group to review the me mbership criteria of CEN and CENELEC so as to 
ensure that principles were fully respected and impl emented by all members; these criteria were wider 
than those contained the WTO TBT Code of Good Pr actice.  Moreover, members would be subject to 
peer assessment.  In conclusion, it was noted that while the EU system was transparent, there was 
always room for improvement, especially with regard  to how to facilitate access and participation in 
the European standardization process.   
85. In response to questions from Pakistan  and Saudi Arabia  on whether the standards were 
voluntary or mandatory for exporters of products into  the European Union, th e speaker confirmed that 
they remained voluntary as standards were consider ed voluntary by nature. In response to a question 
from Saudi Arabia on what was meant by the on-going work being broader than the WTO Agreements, the representative of th e European Union explained that while decisions had yet to be 
taken, there were additional criteria envisaged su ch as peer assessment, benchmarking and exchange 
of best practices. 
86. In response to a question from the representative of Kenya
 on whether standards were 
referred to in EU legislation and if so, whether th ey were available free of charge, the representative 
of the European Union explained that most standard s used within the framework of legislation were 
used within the so called "new approach" regulat ory technique which meant the standards remained 
voluntary. He confirmed that most of the CEN national standard bodies made standards accessible 
free of charge during the public enquiry period.  Concerning a question on how proposed standards were prioritized, he explained that as the sta ndards were proposed, devel oped and approved by the 
stakeholders, and then submitted fo r consultations, it wasn't nece ssary to establish priorities. 
87. The moderator
 commented on how the presentation highlighted that transparency did not 
always mean there was awareness amongst stakehol ders and how SMEs in pa rticular would welcome 
the support provided. 
                                                      
32 http://www.cen.eu. G/TBT/M/51    
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  3. Standards Development Procedures: the Fijian Experience
33 
88. The representative of Fiji  made a presentation on how the Fiji Trade Standards and Quality 
Control Office at the Department of Fair Trading and Consumer Affairs deve loped standards.  She 
said that this was a five stage process.  The first stage entailed an assessment of the new project; stage 
two decided whether a relevant inte rnational standard would be used or whether a new standard would 
be developed; in stage three was public comments were solicited and reviewed; stage four was the 
adoption of the standard; and, finally, stage five  was the introduction of the standard though the 
Official Gazette and the website.34 
89. The representative of Fiji explained that during th e first stage, criteria were used to determine 
whether to proceed with the development of a standard. These assessments were made by experts 
from areas such as consumer protection, professional engineers, importers, manufacturers and 
representatives of the food processing industries so as to  ensure that all relevant stakeholders were 
involved in the initial decision making stages of sta ndards development.  National benefits such as 
quality of life, health and safety, trade, harmoni zation with WTO Agreements were all taken into 
account.  The importance of cost and benefit analys is when developing a standard or mandatory 
technical regulations were also an important factor  when considering the development of a standard.  
90. The representative of Fiji stressed the importanc e of giving all stakeholders and the general 
public enough time to comment. Fiji did this by ensu ring copies of draft standards were available for 
stakeholder viewing and the proposal for the sta ndard was advertised through print and broadcast 
media; a two month comment period was provided d espite these steps, informing stakeholders was 
one of the biggest challenges faced by Fiji. She ga ve the example of a standard on the reduction of 
sulphur content in fuel which had taken over six years to implement as the sub-committee, which was 
composed of experts from fuel importers and othe r stakeholders, was mainly attended by consumers 
rather than importers. This led to importers sayin g they had not been info rmed when the standard 
appeared in the Gazette.  She also  stressed the importance of not re-i nventing the wheel; in Fiji's case 
this meant checking with standards in Australia and New Zealand for standards that were already 
available and made the necessary modifications to su it Fiji's situation.  The representative of Fiji said 
that the benefit of adopting international standard s were apparent as these had facilitated trade and 
they generally reflected the best experience of i ndustry and regulations.  Mo reover, this underpinned 
Fiji's obligations under the TBT and SPS Agreements and facilitated participa tion in international 
certification schemes.  
4. Transparency in Standard-setti ng:  The New Zealand Experience35  
91. The representative of New Zealand  made a presentation on transp arency within the Standards 
New Zealand governance structure, as well as transp arency in standards development.  He began by 
emphasizing the importance of stakeholder interacti on in standard settings.  Standards New Zealand, 
he said, used the Four "Cs" – Clients (those who sponsored the standa rd), Committee (the 
governmental body), Customers (who bought the sta ndards) and finally Consumers (who benefited 
from the standard).  New Zealand operated under the Standards Act 198836 which established the 
Standards Council as a non-profit entity. The St andards Council was the governing body and 
Standards New Zealand was the trad ing arm that actually produced the standards. The Standards Act 
                                                      
33 Ms Seema Sharma, Acting Assistant Director at the Department of Fair Trading & Consumer Affairs 
of the Ministry of Industry, Tourism, Trade & Communication.  
34 www.fiji.gov.fj. 
35 Mr. Craig Radford, international trade and standards specialist responsible for the New Zealand TBT 
Enquiry Point. 
36 http://www.legislation.govt.nz/act/pub lic/1988/0005/latest/DLM128139.html? 
search=ts_act_Standards_resel&p=1.  G/TBT/M/51  
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  required the Council to invite public comment, consult and co-operate with all interest parties, and 
ensure that the Council's activities were supported by  stakeholders.  It also required New Zealand's 
participation in the preparation of internationa l standards and other specifications, and in their 
promulgation. The Ministry of Commerce oversaw  the work of Standards New Zealand and the 
Standards Council through an annual Statement of Intent.37  The representative of New Zealand 
explained that New Zealand followed the ISO/ IEC Guide 59: Clause 6.5, thereby ensuring 
transparency through an appropriate range of orga nizations being invited to submit nominations for 
seats on that Committee. When the standard was pub lished, a list of those participating nominating 
organisations was printed inside the front cover.   
92. Regarding transparency in the development process,  in line with the TBT Agreement, 
Standards New Zealand initially looked at adopt ing international standards as a solution to a 
standardisation need.  Where that was not be an a ppropriate solution, standards jointly developed with 
Australia were looked at.  If producing a joint standa rd was not suitable, then a national standard was 
created as a means of meeting the national need.  On international standards, he said New Zealand 
strongly supported and promoted the work of ISO and IEC and sought the views of key stakeholders 
on all new proposals. Regarding soliciting public  comment, the representative of Nez Zealand 
explained that this was done through compiling an ex tensive list of interested parties who were sent 
the draft standard. For those organizations who were  not part of the Committee, a copy was also sent 
to them for comments, and it was announced in  the monthly electronic magazine, Touchstone38, with a 
60 day comment period.  As the draft was also em ailed to those who registered for updates through 
the "keep me up to date" service, one of the challenges the Committee faced was the huge volume of 
comments received.  
93. The representative of New Zealand spoke about four other aspects of transparency in the 
development process. These were: the comment clau se, whereby many standards had clauses with a 
side-bar containing additional comments to assist  with interpretation of the clause; the SPEC 
(Standards Project Extranet) – an IT platform where all committee members could view documents, 
discussion thread and information; the Official  Information Act 1982 which required that all 
information gathered during the development of th e standard be made available to anyone who 
requested it; and finally, ISO 9000 certification wh ich ensured compliance wi th international quality 
standards which included internal project audits  to ensure quality requirements – of  which 
transparency was one - were met.  In summing up,  the representative of New Zealand said that his 
country had a strong transparency focus throughou t the standards development process, he also 
emphasized the significant use of electronic communication as a tool for transparency. 
5. How ISO and IEC involve public and private sec tors to ensure transparency in setting 
international standards39 
94. The representative of IEC (speaking also on beha lf of the ISO) highlighted the social and 
economic benefits of ISO and IEC in ternational standards to industry, regulators and consumers. They 
inspired trust and helped industry to comply with regulations. Also, standards such as those developed 
by the ISO and IEC,  facilitated the elimination of  unnecessary barriers to trade.  The development of 
an international standards, he said, represented a collective effort on a voluntary basis by committees 
comprised of experts from industry, business and t echnical sectors that had identified the need for a 
standard.  He stressed that, unlike in other types of standard setting bodies, all stakeholders could 
participate in the process. More than 25,000 inte rnational standards had been produced by ISO and 
                                                      
37 http://www.standards.co.nz/NR/rdon lyres/4B0BA081-2 FA8-4AC5-A26A-
8DCEAE6B150B/0/StandardsCouncil20102013StatementofIntent.pdf. 
38 www.standards.co.nz/touchstone/Issue+20/default.htm. 
39 Jonathan Buck, Director at IEC responsible for the organization's outreach to industry and 
government leaders. G/TBT/M/51    
Page 86  
 
  IEC with 100,000 experts worldwide participating in  their development. The representative of the IEC 
explained that to ensure effective representation,  experts in technical committees met to discuss and 
debate the content of a standard until they reached a consensus view.  It was then published as a draft 
international standard and circulated to all ISO or IEC members for comment.  Comments received were then compiled and discussed until a final draf t was agreed upon for voting.  Once approved, the 
document was published as an international standard.  
95. The representative described the National Sta ndard Bodies (NSBs) of ISO and National 
Committees (NCs) of IEC as the key bodies for collecti ng national views on international standards.  
They identified, supported and funded the partic ipation of national dele gates, conducted public 
enquiries, published and distributed standards a nd promoted their use.  Their well-established 
networks throughout all areas of the economy and professional bodies meant they could easily reach 
stakeholders.  In many countries "mirror" Committees of one or several ISO or IEC technical committees, tailored to national needs were cr eated on a particular technology undergoing 
standardization.  Considerable e fforts were being made by ISO and the IEC to encourage participation 
in the standard-setting processes, particularly am ongst SMEs in developing an d developed countries.  
Both organizations, he said, offered programmes and platforms that encouraged participation in the 
standard setting processes.
40   
96. The representative of the IEC recalled that the Fifth Triennial Review had underscored the 
importance of basing technical regulations a nd conformity assessment procedures on relevant 
international standards, guides or recommendations  in line with Articles 2.4 and 5.4 of the TBT 
Agreement.41  He reiterated the unique added-value of in ternational standards and ISO's and IEC's 
long experience in international consensus building, and their transparent and highly inclusive nature 
of their development processes.  In his view, the ISO and IEC business models ensured that 
international standards were developed in a neut ral environment, thereby ensuring global reach and 
relevance and this made both the ISO and IEC brands among the most widely recognized and 
respected brands in the world.  
97. In response to a question from the representative of Benin  on the non-standard sizes and 
shapes of plugs and sockets interna tionally, the representative of IEC  explained that attempts to 
develop an international standard went back 75 years without success, as the costs of worldwide 
installation of one standard plug and socket were too prohibitive.  He said this particular area acted as 
a reminder not to make the same error when applying smart grid technologies today.   
98. The representative of IEC also drew the Committe e’s attention, with respect to a question 
raised by the delegation of Kenya  about publicly available drafts.  In this regard he drew the attention 
of the Committee to several national on-line regi stration systems being implemented in many 
countries, whereby registered users were allowed access a draft standard so long as they agreed to 
limit the use of the draft. 
99. In response to a question from the representative of Switzerland  on cooperation between 
ASTM and ISO, the representative of ASTM  explained that while there was no formal partnering 
between the two organizations, many ASTM standards formed the basis of ISO work.  This had led to 
concerns as ASTM was not always getting brand rec ognition.  In the future, he said, he hoped that 
there would be a programme that combin ed all globally relevant standards.  
100. The representative of ISO  confirmed that discussions were on-going between ASTM and ISO 
on how work could be better coordi nated between the two organizations. 
                                                      
40  ISO's DEVCO and the IEC Affiliate Country Programme. 
41   G/TBT/26, paragraphs 24, 25 and 27.   G/TBT/M/51  
 Page 87 
 
 
  6. Embracing Transparency and WTO Principl es for International Standardization - 
ASTM International's Global Approach to Standards Development42  
101. The representative of ASTM said that ASTM w as established in 1898; it currently had 34,000 
members in 135 countries.  Each member was an individual technical expert with a voting right in the standards development process.  12,160 standards had been published with an average of 3,200 
standards actions per year which included new sta ndards, revisions, re-approva ls, and withdrawals of 
standards.  The representative of ASTM highlighted  the diversity of the membership, noting that it 
included heads of the German, Brazilia n and Japanese standards organizations. 
102. The representative of ASTM said that his organi zation had invested heavily in technology so 
as to help boost participation in all standard setti ng environments.  To do th is, ASTM had established 
the "International Standards Tracker"
43 – an on-line notification service which provided information 
on newly approved standards and actions on existing standards free of charge.  Also, to enhance 
transparency, the ASTM magazine was published in English, Chinese, Japanese and Spanish and 
standards were translated into multiple languages e ither by ASTM or through translation agreements 
with interested countries.  Employing multilingual st aff gave the opportunity to address concerns and 
comments in other languages other than English.  He informed delegations of a successful MoU 
programme44 which provided, free of charge, the complete  collection of ASTM standards which could 
be used as models for national standards or tec hnical regulations. The only obligation on the partner 
was to report yearly on the use of the ASTM standard.  In ten years, MoUs with 69 emerging 
economies had been signed. These countries also benefited from technical assistance from ASTM experts in building awareness and knowledge in applying standards. Another way ASTM had 
enhanced transparency, the represen tative said, was through the use of virtual meetings.  In 2009, 933 
virtual meetings had taken place which greatly acceler ated standards work, engaged more participants 
and also enabled 350 MoU beneficiaries to participat e.  ASTM also had a significant digital library 
with all 12,000 ASTM standards including abstract s available to view prior to purchase.   
103. The representative of ASTM assured the Committe e that ASTM was committed to comply 
fully with WTO principles such as transparency, openness and the considerations of developing 
countries which could be seen through the use of 5, 200 citations of ASTM standards in 100 countries 
worldwide. 
104. In response to a question from the representative of Benin
 on the non-standard sizes and 
shapes of plugs and sockets interna tionally, the representative of ISO  explained that attempts to 
develop an international standard went back 75 years without success, as the costs of worldwide 
installation of one standard plug and socket were too prohibitive.  He said this particular area acted as 
a reminder not to make the same error when applying smart grid technologies today.   
105. The representative of ISO also drew the Committe e’s attention, with respect to a question 
raised by the delegation of Kenya  about publicly available drafts.  In this regard he drew the attention 
of the Committee to the ISO on-line registration system being implemented in many countries, whereby registered users were allowed access a draft standard so long as they agreed to limit the use 
of the draft. 
106. The representative of ASTM
 explained that they provided "read only" copies of standards 
during the development and review process so that all concerned could review the draft.  
                                                      
42 Mr. James A. Thomas,  President of ASTM International. 
43 www.astm.org/TRACKER/filtr exx40.cgi?index.frm. 
44 www.astm.org/ABOUT/images/ASTM_AR09.pdf. G/TBT/M/51    
Page 88  
 
  107. The representative of New Zealand
 confirmed that all public comment drafts were free for 
download from their website.  As there were intellectual property concerns in cases where draft standard was adopted as an international standard, a registration system similar to that of ISO was 
used. 
108. In response to a question from the representative of Switzerland
 on cooperation between 
ASTM and ISO, the representative of ASTM  explained that while there was no formal partnering 
between the two organizations, many ASTM standards formed the basis of ISO work.  This had led to 
concerns as ASTM was not always getting brand rec ognition.  In the future, he said, he hoped that 
there would be a programme that combin ed all globally relevant standards.  
109. The representative of ISO  confirmed that discussions were on-going between ASTM and ISO 
on how work could be better coordi nated between the two organizations. 
110. The moderator  concluded that the session had shown the many challenges faced in ensuring 
stakeholder awareness and participation in the devel opment of standards, in particular for SMEs.  The 
use of electronic tools and websites was highlighted  in a number of presentations as a way of helping 
to meet this challenge and to reduce the length of  time the process took, but there were financial and 
technical barriers to consider.  This, she said, was an area where a lot more discussion could take 
place.  She concluded that the session had shown that  for the credibility of standards, transparency 
throughout the standard setting process was important. 
_______________ 
   G/TBT/M/51  
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  ANNEX 2 
REPORT BY THE CHAIRMAN ON THE SIXTH SPECIAL MEETING ON PROCEDURES 
FOR INFORMATION EXCHANGE UNDER THE TBT AGREEMENT  
Statement by the Chairman  
 
Mr. Amit Yadav (India)  
 
Regular Meeting of the TBT Committee of 23-24 June 2010 
 
 
1. Pursuant to its 1995 decision to convene, on a bien nial basis, "regular meetings of persons 
responsible for information exchange, including  persons responsible fo r enquiry points and 
notifications", the TBT Committee held its Sixt h Special Meeting on Procedures for Information 
Exchange on 22 June 2010.  Members, Observers an d relevant bodies involved in the development of 
standards were invited to participate.   
2. The Special Meeting provided Members with an opportunity to discuss, at a technical level, 
issues relating to information exchange and to re view the functioning of notification procedures and 
the operation of enquiry points.  Discussions were held in four panel sessions dealing with (i) good 
practices in notification; (ii) electronic database s; (iii) operation of en quiry points; and (iv) 
transparency in standard-setting.  The final pr ogramme for the Special Meeting is contained in 
document G/TBT/GEN/100. 
3. In the First Session1 Members discussed Good Practices in Notification.  The Panel 
examined, inter alia , ways to facilitate internal coordinati on for the effective implementation of the 
TBT Agreement's notifications obligations.  For inst ance, we heard of how Canada uses "triage" and 
RIAs in the context of the implementation of notification obligations.  We also heard about 
procedures the European Union has put in place, for in stance: to make available draft texts (of notified 
measures); to provide unofficial translations; to provide comprehensive descr iptions of notified texts 
as well as links to "earlier" acts and impact asse ssments.   The United States spoke about their 
practices and procedures for notifications, both the cen tral and sub-central government levels.  It was 
emphasized that the US process is a notice and co mment procedure.  The use of the US Federal 
Register was described, as well as the "State Net", an  on-line service for regulatory reporting.  In the 
discussion, participants brought up, inter alia , issues related to: "follow-up" on notifications, the 
notification of acts or bills passed by legislative bodies and the use of RIAs.  
4. In the Second Session2 Members discussed various electronic databases.  This was a popular 
session: several experiences were h eard, including from Chile, China,  the European Union, India, 
Indonesia and the United States.  It is clear that with the increasing number of notifications, the importance of good management of information is growing – this was a point emphasized by the 
European Union.  Both Chile and Indonesia stresse d that for the creation of the database (which 
involved making an inventory of the "universe" of regulations), it was important to have good 
coordination with involved agencies.  In fact, th is process of coordination and cooperation was in 
itself useful – and it would appear that Members i nvolved in this had enhan ced their implementation 
of the TBT Agreement's transparency provisions.  China provided some interesting information from 
their own database (a combined TBT and
 SPS database): for instance, in 2009, the largest proportion 
of notifications were on food produc ts and the most notified "objective" dealt with the protection of 
human safety, quality and the environment.  India stressed some of the challenges, including that 
several notifications (by several Members) may affe ct the same product:  for the exporters, therefore, 
                                                      
1 Chaired by Ms Xueyan GUO (China). 
2 Chaired by Mr. Juan Antonio Dorantes Sánchez (Mexico). G/TBT/M/51 
Page 90  
 
  it would be useful to search by product – in this re gard, the lack of (and/or inconsistent use of) HS 
nomenclature in notifications is a problem.  We also heard about the "Notify US" and the WTO TBT 
IMS application was also introduced.  In the discussi on, a number of other challenges were identified, 
such as: the fact that languages continue to pose a problem for many Members; that technical 
assistance may be needed to assist with the setting up and use of databases; and that IT could still pose 
obstacles in some developing Members countries.  It  was also proposed that the TBT IMS application 
could include a page with links to various Memb ers' existing databases on TBT notifications.    
5. In the Third Session
3 Members described the challenges associated with the operation and 
functioning of enquiry points.  We heard an update from Brazil on INMETRO and the establishment 
of Alerta Exportador! .  Paraguay described the functioning of their Enquiry Point: this was a good 
example of how a reorganization had reinforced  the implementation of the TBT Agreement's 
transparency provisions.  Several challenges were ra ised in the presentations and discussions.  Turkey 
noted that the increasing number of notificati ons was putting more burden on enquiry points. 
Moreover, escalating bilateral and plurilateral negotiations on TBT i ssues, the lack of personnel and 
frequent changes thereof added to the strain.   In  the discussion, it was stressed that enquiry points 
need to find better ways of involving the private sect or, and in particular the export sector.  In this 
regard it was important to obtain a balanced  and varied input from stakeholders.   
6. Finally, in the Fourth Session4 Members considered transparency in the development of 
standards.  Several issues were raised in this S ession: I should perhaps say first and foremost that all 
agree on the fundamental importance of transparency in the development  of standards.   However, 
transparency, even when assured will not always translate to increased awareness – Members need to 
work on increasing awareness of the importance of sta ndardizing activities – this is important for the 
credibility of standards: transparency has to come fi rst; if you don't have transparency, credibility will 
not follow.   It is clear from this session that st andards-setting bodies are aware of this.  For instance, 
we heard of efforts in the European Union to in volve SMEs.  Also, Egypt and Fiji spoke about how 
transparency is ensured in the deve lopment process in their countries; Fiji, in this regard, stressed the 
importance they put on the need to assess the benefits  of standards – and that standards should only be 
developed if benefits outweigh costs.  We also heard from ISO/IEC and ASTM International on their 
mechanisms aimed at increasing awareness and partic ipation in standardization activities.  From 
comments made by the various speakers, it became clear that the activity of stakeholders in the 
development process of standards varies: while some Members have many comments on standards 
under development (New Zealand), others expressed concern of about the need for a more balanced 
and/or varying stakeholder involvement in the co mment process (Fiji).  Al so in the discussion, 
Pakistan emphasized the need for Members to par ticipate in the development of standards at the 
international level. 
7. Let me conclude  by noting that the discussions at the Special Meeting held on 22 June were 
rich and important.  In fact, participation was substantial: it included 96 capital-based officials from 
developing countries sponsored by the WTO through the Global Trust Fund.  I can only encourage a 
continued exchange of information between Memb ers on the implementation of the TBT Agreement's 
obligations. In fact, in the Comm ittee context, this technical discussion should help us move forward 
on the numerous recommendations we have be fore us from our triennial reviews.  
8. Before turning continuing with our agenda, let me mention that a summary report on the Sixth 
Special Meeting on Procedures for Information Exchange will be prepared by the Secretariat.   I also 
note that the presentations used during this event will be put on the WTO TBT Webpage. 
__________  
                                                      
3 Chaired by Ms Meike Wolf (European Union). 
4 Chaired by Mrs Michelle Cooper (Canada).