RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/45 
9 September 2008 
 (08-4232) 
Committee on Technical Barriers to Trade  
 
 
 
MINUTES OF THE MEETING OF 1-2 July 2008 
 
Chairperson:  Ms Xueyan GUO (China)  
 
Note by the Secretariat1 
 
  
I. ADOPTION OF THE AGENDA ......................................................................................................... .......2  
II. ELECTION OF CH AIRPER SON........................................................................................................ ......2 
III. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT........................................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 ................................................................................2  
B. SPECIFIC TRADE CONCERNS ........................................................................................................................2  
1. New Concerns ................................................................................................................... ....................2  
2. Previously rais ed concerns ..................................................................................................... ..............6  
C. EXCHANGE OF EXPERIENCES ....................................................................................................................33  
1. Good Regulato ry Prac tice....................................................................................................... ............33  
2. Conformity Assessm ent Procedures ............................................................................................... .....35  
3. Transparency ................................................................................................................... ...................35  
4. Technical As sistance ........................................................................................................... ................36  
5. Special and Differe ntial Treatment............................................................................................. ........37  
IV. TECHNICAL COOPERATION ACTIVITIES ......................................................................................37  
V. UPDATING BY OBSERVERS.......................................................................................................... .......39  
VI. OTHER BUSINESS................................................................................................................. ..................40  
VII. DATE OF NEXT  MEETI NG........................................................................................................... .........41  
 
                                                      
1 This document has been prepared under the Secr etariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. G/TBT/M/45 
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I. ADOPTION OF THE AGENDA 
1. The Committee adopted the agenda contained in WTO/AIR/3204. 
II. ELECTION OF CHAIRPERSON 
2. Pursuant to Article 13.1 of the TBT Agreem ent, the Committee elected Ms Xueyan GUO 
(China) as the Chairperson of the TBT Committee. 
III. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 
3. The Chairperson  recalled that the latest list of statements submitted under Article 15.2 of the 
TBT Agreement was contained in document G/TBT/ GEN/1/Rev.7, issued on 7 March 2008.  Since 
1995, a total of 117 Members had submitted at leas t one statement on implementation under Article 
15.2.  Since the last meeting, held in Marc h 2008, Albania and Ukraine had submitted their 
Statements under Article 15.2 (G/TBT/2/Add.99 and G/TBT/2/Add.100, respectively), and Ghana 
(G/TBT/2/Add.76/Rev.1), Indonesia (G/TBT/2/Add.3/ Rev.2) and Paraguay (G/TBT/2/Add.91/Rev.1) 
had submitted revisions to their Statements.  It was also noted that the latest list of Enquiry Point 
contacts is contained in document G/TBT/ENQ/33.2     
4. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
5. The Secretariat  introduced a draft document (JOB(08)/53) containing an overview of specific 
trade concerns raised in the TB T Committee to date (since 1995).   
6. The Chairperson  encouraged delegations, when raisi ng a new specific trade concern at the 
TBT Committee, to inform the Chairperson through th e Secretariat, as well as the Member concerned, 
in advance of the meeting.   
7. The representatives of Canada  and Chinese Taipei  stressed the importance of Members' being 
informed prior to the Committee meeting about specifi c trade concerns to be raised.  It was proposed 
that the Committee follow the example of the SPS Committee by setting a deadline for Members to 
communicate to the Secretariat their intention to rai se specific trade concerns at the meeting in order 
to give sufficient time for the preparation of responses. 
1. New Concerns 
(i) Brazil – Regulation on Identifica tion and Quality Standards of Eethyl Alcohol and other 
Spirits (G/TBT/N/BRA/276, Suppl.1) 
8. The representative of Mexico  raised concerns about a draft regulation on identification and 
quality standards for alcoholic beverages, notif ied by Brazil on 7 May 2008 (G/TBT/N/BRA/276), 
which set out, among other things, the specifications  for identity and quality of different alcoholic 
drinks.  Although the reference to tequila was of par ticular concern to his delegation, the regulation of 
other alcoholics such as rum and gin was also a matter of concern. 
                                                      
2 Regularly updated information on Members' enquiry points is also available on the following TBT 
webpage: http://www.wto.org/english/tratop_e/tbt_e/tbt_enquiry_points_e.htm   G/TBT/M/45 
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  9. The representative of Mexico drew the Committee's attention to the fact that tequila had been 
an appellation of origin recognized by the Mexican government since 1974, and had been registered within the trademark office of the World Intell ectual Property Organisation (WIPO) in 1977.  He 
recalled that appellations of origin indicate the geog raphical nature of the country or the region used 
to designate a product from a certain place whose characteristics are essentially related to the 
environment, and in particular to natural and human factors.  In th is regard, the tequila originated 
from a Mexican region called "Tequila", where a number of natural factors combined and created a unique area which provided the product with its exclus ive characteristics.  Al so, the antique tradition 
of tequila production, which had been transmitted through many generations, created human factors 
which permitted tequila to be recognized as a hi gh quality product on international markets. 
10. The representative of Mexico also informed th e Committee that a complex regulation on the 
manufacturing of tequila had been in force since 2005 (006-SCFI 2006).  In particular, to guarantee 
the authenticity of tequila, the Mexican governme nt had implemented a protection system which 
included: (i) an identification of the geographical  zone used for the production of tequila's raw 
material; (ii) specific technical regulations; (iii) a regulatory body which controlled compliance with 
technical requirements; (iv) export controls; and (v) inspection procedures.  The Mexican technical 
regulation also set out other requirements for specifi c categories of tequila, including: controls on the 
manufacturing process, water quality, physical and chemical analysis, labelling and bottling 
requirements.   
11. The Mexican representative emphasized that tequ ila was a product internationally recognized 
as originating from Mexico and needed therefore to be produced in compliance with Mexican 
legislation.  It was the view of his delegation th at Brazil set a definition of tequila and referred to 
requirements that were incompatible with those set by Mexican legislation, and there was no scientific 
justification.  The Brazilian draft regulation was ther efore incompatible with several provisions of the 
TBT Agreement, the GATT 1994 and the TRIPS Agre ement.  In particular, the draft regulation 
contained requirements that were inferior to those allowed for in Mexico with regard to methanol, 
aldehyde, lead, copper, and others wh ich limited the percentage of alc ohol per volume.  It was pointed 
out that such measures would limit the types of tequ ila that could be commercialized in Brazil, and 
would favour the marketing of lower quality products.   
12. It was Mexico's understanding that the legitimat e objective identified by Brazil with regard to 
the draft regulation was:  the protection of consumers from misleading or deceptive practices.  However, the representative of Mexico believed that the draft regulation would not fulfil such 
legitimate objectives, but would rather constitute an  unnecessary barrier to trade.  He therefore asked 
Brazil to clarify the legitimate objectives of the draf t regulation in accordance with Article 2.2 of the 
TBT Agreement and stated that Mexico would pr esent its written comments to Brazil in order to 
further discuss the issue. 
13. The representative of th e European Communities
 shared the concerns expressed by Mexico.  
She stressed that the proposed dr aft regulation would have a serious impact on European exports of 
spirits to Brazil.  First, the draft standard define d the category of spirit drinks in terms of chemical 
components by means of analytical parameters ; however, the European Communities - along with 
other countries - defined categories of distilled sp irits in terms of raw materials and production 
processes.  The divergence in standards could constit ute an unnecessary obstacle to trade.  Second, the 
alcohol content requirements established in the prop osed Brazilian regulation did not conform to the 
international standards for most spirit categories;  therefore, the European Communities urged Brazil 
to retain minimum strength requirements only and align these with internationally accepted values.  
Finally, the draft regulations restricted the use of  certain flavourings in spirit drinks exported to 
Brazil, thereby causing negative impacts on European e xports to Brazil.  In concluding, the European 
Commission invited the Brazilian authorities to take into account both its oral and written comments. G/TBT/M/45 
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  14. The representative of Brazil
 recalled that the regulation at issue was still a draft currently 
under public consultation.  He c onfirmed that Mexico had additional time to submit its comments, and 
recalled that any comments would be taken into account before the adoption of the regulation.  
However, Brazil stressed that the draft regulation on  identification and quality standards for alcoholic 
beverages was intended to create identity and qualit y requirements for spirits, and had no relation with 
intellectual property issues. 
(ii) Germany – Changes in the Prohibition of Chemicals Ordinance 
15. The representative of Israel  drew the Committee's attention to the changes that Germany 
intended to apply to its Prohibiti on of Chemicals Ordinance.  He expressed concerns about the fact 
that, following the proposed chang es, some chemicals that were widely used as fertilizers would be 
listed as propellants for explosives.  It was not ed that the proposed regulation would require 
registration and training from the importers of the listed "explosive substances" .   His delegation was 
particularly concerned about two substances incorpor ated in the new list which were mainly produced 
in Israel: sodium nitrate and potassium nitrate.  The representative of Israel pointed out that calcium 
nitrate, a substance with similar chemical propertie s, was not listed as an "explosive substance".  
Israel believed that the inclusion of sodium a nd potassium nitrate in the list was an unnecessary 
obstacle to trade and that the measure could create competitive distortions for Israeli products. 
16. The representative of Chile  shared the concerns expressed by Israel. 
17. The representative of the European Communities  explained that the draft neither provided for 
a prohibition of substances nor did it lay down a tech nical regulation as defined in the Annex 1 of the 
TBT Agreement; it only provided for certain selling a rrangements such as the obligation for buyers to 
identify themselves.  This was why the draft ha d not been notified under the TBT Agreement.  
However, the European Communities took note of  the comments provided and expressed willingness 
to discuss this issue bilaterally. 
(iii) Colombia – Regulation on Wine labelling 
18. The representative of Chile  expressed concern about a new standard on the labelling of 
liquors and wines which had entered into force in Colombia, as contained in the Decree 22/70 of 23 
June 2008.  His delegation was particularly concer ned about the fact that there had neither been 
consultation prior to the publication of the decree nor a notification to the WTO.  The nature of the 
measure was also unclear.  He asked the delegation of Colombia to provide additional information on 
the nature and objective of the measure and r ecalled that the obligation contained in the TBT 
Agreement with respect to providing a reasona ble time for comments had not been met.  
19. The representative of Colombia  took note of the concerns raised , and asked Chile to also send 
their comments to the Enqui ry Point in Colombia. 
(iv) Indonesia – Zinc Coated Steel Sheet (G/TBT/N/IDN/17) 
20. The representative of Korea  raised concerns about the draft De cree of the Ministry of Industry 
regarding a Mandatory Indonesian Standard (SNI 07 -2053-2006) for Zinc coated steel sheet, which 
had been notified on 1 October 2007 by the Indonesian  Government.  The Enquiry Point of Korea had 
submitted questions to Indonesia on 20  June 2008 and an answer was expected.  In particular, he 
pointed out that that intermediate goods which were used in car manufacturing and consumer 
electronic goods were not directly related to consum er protection.  Therefore, they needed to be 
excluded from a list of necessary accreditation goods in order not to give rise to any unnecessary trade 
restrictions.  He stressed that similar measures should be notified promptly to the TBT Committee in 
the future.   G/TBT/M/45 
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  21. The representative of Indonesia  informed the Committee that a reply was being prepared 
which would be sent shortly to the Enquiry Point of Korea. 
(v) Indonesia – Requirements for Rubber Hoses for LPG Gas Stoves (G/TBT/N/IDN/19) 
22. The representative of the European Communities  raised an issue with regard to a Ministerial 
Decree affecting rubber hoses, notified on 5 February  2008 (G/TBT/N/IDN/19).  In particular, her 
delegation was concerned about the provision which stat ed that the colour of rubber hoses had to be in 
orange.  It was noted that orange was not the colour  generally used for gas stoves; the colours used in 
common practice were blue or white and these were  not imposed by any rule or standard.  The 
European Communities believed that the colour re quirement did not fulfil a legitimate objective and 
thereby created an unnecessary obstacle to trade cont rary to Article 2.2 of the TBT Agreement. 
23. The representative of the European Commun ities noted that written comments had been 
provided, including with respect to certain drafting incoherencies in the notification.  Her delegation 
requested Indonesia to take into account the comment s and to clarify whether the Ministerial Decree 
had already been adopted. 
24. The representative of Indonesia  took note of the comments and informed the Committee that 
some amendments were still being made; Member s would be informed about progress as soon as 
possible.  
(vi) Brazil – Wines (G/TBT/N/BRA/238) 
25. The representative of the European Communities  raised concerns about a measure on wine, 
notified by Brazil on 26 March 2007 (G/TBT/N/BRA /238), which imposed, among other things, an 
increase in the number of parameters that had to be evaluated and on certificates that were requested.  
At the time of notification the European Co mmunities had submitted written comments, which had 
only been partially clarified by Brazil.  In particular, the European Communities invited Brazil to indicate the reasons for departing from the levels and parameters established at the international level, 
and to explain the legitimate objective pursued by the measure.  Finally, the European Communities 
invited Brazil to give further information on th e public consultation launc hed on 2 June 2008 on 
import requirements for wines, and to clarify whethe r the parameters which had to be evaluated would 
be reviewed as a result of this consultation. 
26. The representative of Brazil
 took note of the comments made. 
(vii) China – Energy Efficiency and Energy E fficiency Grades for Copy Machines 
(G/TBT/N/CHN/331, Rev.1 and Suppl.1) 
27. The representative of Japan  appreciated the Chinese delegation's reply to comments on the 
Act affecting copy machines, notified on 19 February 2008 (G/TBT/N/CHN/331/Rev.1).  
Nevertheless, Japan raised furthe r concerns on two specific points.  First, there were no mandatory 
requirements of this kind at the international level; th e measure at issue could, therefore, constitute an 
unnecessary obstacle to trade.  Second, it was all but impossible to measure energy efficiency 
accurately, and also very difficult to decide whethe r copy machines were copy or printer based.  In 
this respect, Japan invited China to clarify the scope of the measure. 
28. The representative of China  took note of the comments made. G/TBT/M/45 
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  (viii) Korea – Country of Origin Labelling Re quirements for Certain Imported Fruit 
29. The representative of the United States
 appreciated Korea's willingness to continue a dialogue 
with respect to US concerns rega rding Korea’s country of origin labelling requirements for certain 
imported fruits.  It was his delega tion's understanding that the Korean Customs Service required the 
labelling of country of origin on the actual product for seven types of imported fruit for bulk sale, 
namely: sweet pumpkin, bananas, oranges, pineappl e, melons, watermelons and durians.  Meanwhile, 
the rules for the like domestic products, which were governed solely by National Agricultural 
Products Quality Management Servic e (NAQS) requirements, appeared to be much less stringent.  In 
fact, country of origin labelling did not need to be on each individual piece of fruit, but could rather be 
on the container surface.  The United States noted that the Korean government had begun to modify 
its labelling requirements for fruits a nd vegetables; it was its expecta tion that Korea would take steps 
to ensure that it treated imported a nd domestic fruits and vegetables equally. 
30. The representative of Mexico  echoed the concerns expressed by the United States. 
31. The representative of Korea  noted that his delegation had ha d a bilateral meeting with the 
United States and expected the issue to be concluded soon. 
2. Previously raised concerns 
(i) European Communities – Regulation on the Regi stration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52, Adds 1-5 and Add.3/Rev.1) 
32. The representative of Argentina  reiterated his delegation's concerns with respect to REACH 
and drew Members' attention to two documents  submitted in this regard (G/TBT/W/286 and 
G/TBT/W/289).  The EC regime in the area of chemicals continued to present serious difficulties for 
Argentina as it distorted conditions of competition in tr ade in prepared chemical substances.  He drew 
the Committee's attention to the limited capacity of the European Communities and the European 
Chemical Agency (ECHA) to provide adequate t echnical assistance to users.  In addition, the 
complexity of REACH, coupled with the lack of a ppropriate technical assistance, was contributing to 
increased confusion and concerns among companies that were trying to comply with REACH; Small 
and Medium sized Enterprises (SMEs) were especially affected.   
33. The representative of Argentin a recalled that, on 21 April 2008, Argentina had sent, through 
the focal point of the TBT WTO Committee, two qu estionnaires with specific questions relating to 
REACH.  Also, the Argentinean petrochemical indus try had sent the EC Helpdesk six basic questions 
and still not received a reply other than a refere nce to a website which contained information on 
REACH. This was not satisfactory.  Moreover, ther e were questions about the legal liability of the 
information provided on these websites.  This situati on was aggravated by the entry into force of the 
period of pre-registration.  Although Argentina had received some replies to questions on 
27 June 2008, these had yet to be analyzed.  In sum, the REACH re gulation was complex, it lacked 
transparency and technical assistance was both insuffici ent and lacking in legal validity.  This resulted 
in confusion and concern amongst enterp rises that were trying to comply.   
34. The representative of Chinese Taipei  associated himself with Argentina's comments and 
encouraged the European Commun ities to take into account the impact of REACH on Small and 
Medium sized Enterprises (SMEs), to publish a ll the technical guidelines for REACH and inform 
trading partners about their availability.  G/TBT/M/45 
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  35. The representative of Mexico  joined other delegations in concerns expressed about REACH.  
While thanking the European Communities for holding a workshop on REACH on 14 April 20083, he 
nevertheless noted that concerns remained.  Effo rts to provide technical assistance to developing 
countries needed to continue in order to enable th ese countries to implement the measures at issue in 
the best possible way.  Similarly, special and differential treatment needed to be provided.  
36. The representative of Brazil  shared the concerns already expressed by others, stressing the 
difficulties imposed by the "Only Representative" re quirement, especially in the case of SMEs.  In 
particular, the representative of Brazil recalled th at Brazilian industry was seriously concerned about 
the registration requirements for reacted monomers in polymers.  He noted that REACH exempted polymers from registration and evaluation, as they were widely believed to cause minimal risk.  
Nevertheless, REACH required manuf acturers or importers of polymer s to register reacted monomers 
used in the production of polymers.  It was noted th at such a situation could constitute discrimination 
between EC and non-EC manufacturers, since only th e monomers in the polymers created by the EC 
manufacturers would be registered.  Therefore, th e representative of Brazil encouraged the European 
Communities to clarify the rationale for the regist ration of reacted monomers in polymers and give 
further information on the status of the related case recently submitted to the European Court of 
Justice. 
37. The representative of Australia
 joined the concerns expres sed by previous speakers, 
emphasizing the challenges faced by non-EC industri es in complying with REACH.  While Australia 
supported the objectives of the protection of human h ealth and the environment, the disproportionate 
impact of such a policy on SMEs and the fact that the "Only Representative" provision could place 
higher costs on non-EC producers and manufacturers remained a concern.  The representative of 
Australia welcomed the development of REACH gui dance documents by the European Communities, 
but noted that key issues for non-EC industries were unclear.  More in-country or in-region assistance from EC experts was necessary to assi st the industry's understanding of  pre-registration requirements 
under REACH. 
38. The representative of Japan
 raised some questions concerning REACH.  He sought 
clarification on whether substance manufacturers who did not directly export to the European Communities but were upstream from other businesses c ould also appoint and register their substance 
through the "Only Representative".  It was noted th at, in light of the limited timeframe for pre-
registration requirements, many Japanese firms would not  be able to respond appropriately if such an 
issue remained unclear.  The representative of Japan sought confirmation on the future REACH 
schedule, and in particular on the number of substa nces included therein and on whether the European 
Communities would ask for Members' comments before reaching a final decision on the schedule.  He 
also requested the European Comm unities to base their decisions on approval of substances only upon 
reasonable scientific evidence.  He noted that , according to the "Guidance on requirement for 
substances in articles" published in May, the concen tration threshold of 0.1 per cent referred to the 
average concentration of the entire article as produ ced or imported.  However, dissenting views of 
some EC member States created confusion and un certainty in this respect and needed to be 
eliminated.  The representative of Japan also re quested that foreign-based firms in European 
Communities be treated without discrimination, and that their opinions be respected when participating in "SIEF" (Substance Informati on Exchange Forum) – although, it was noted, an 
exchange of information had been already underway.   
39. The representative of Thailand
 referred to her delegation's previously expressed position on 
REACH.  While Thailand supported the objectives of the protection of human health and the 
environment, the complexity of REACH was be yond the capacity of many developing and least 
                                                      
3 Information about the REACH workshop can be found at: 
http://ec.europa.eu/enterpri se/reach/events_en.htm#video  G/TBT/M/45 
Page 8  
 
  developed countries to understand and comply with.  Particularly for SMEs, which represented the 
majority of Thailand's industry. 
40. The representative of China
 shared the concerns expressed  by previous speakers. In 
particular, he stressed the need for technical assistan ce to assist industries of developing countries in 
implementing REACH.  He encouraged the Euro pean Communities to send experts to China to 
discuss the practical concerns of the industry.  Wh ile appreciating the efforts made by the European 
Commission to provide transparency, he neverthel ess noted that Chinese industries were particularly 
concerned about the high fees and charges associat ed with registration procedures, and urged the 
European Communities to give further clarification on the fee structure, and to provide special and differential treatment for developing countries.  Th e representative of China also expressed concerns 
about the current uncertainty of the "Only Repres entative" requirement.  His delegation urged the 
European Commission to further clarify this mech anism, explaining in particular whether non-EC 
manufacturers could continue their exportation usi ng the information and data already submitted even 
once the Only Representative designated would go bankrupt.  
41. The representative of Chile
 shared many of the concerns raised by previous speakers.  Having 
set up a committee meant to deal directly with  REACH, Chile remained convinced that the 
implementation of REACH would be complex.  The main concerns of Chile were about the 
complexity of the registration process and possible differences of interpretation among different EC 
member States which could arise with respect to the implementation of REACH.  The representative 
of Chile reiterated the need for technical assistance  from European experts, so that REACH could be 
better understood and applied. 
42. The representative of the United States  noted that his delegation supported the objectives of 
protecting health and the environment.  However,  concerns remained that the REACH regulation 
appeared to be overly broad and to adopt a partic ularly costly, burdensome, and complex approach 
that could disrupt and distort global trade.  The Un ited States continued to study the regulation and its 
potential trade impact and was closely monitoring the EC implementation process.  The representative 
of the United States recalled the detailed US interv ention on the concerns regarding REACH given at 
the last Committee meeting and shared many of the concerns that had already been raised by other 
delegations at current meeting about the Only Repr esentative, the candidate list, the burden on SMEs, 
and the potential for differential enforcement of REACH across the EC member States.  
43. Given the start of the pre-registration timefra me for REACH, the representative of the United 
States also wished to raise the i ssue of cosmetics.  Cosmetics had not previously been discussed at 
length in the TBT Committee given that the matter ha d been the subject of intense discussion in the 
Transatlantic Economic Council (TEC).  It was noted  that REACH appeared to grant the preferential 
status of "phase-in substances" to many "exist ing substances" used in cosmetics that were 
manufactured in the European Co mmunities, since those substances were listed in the European 
Inventory of Existing Chemical Substances (EINEC S).  By contrast, many existing substances in 
cosmetics that were manufactured abroad, not listed on EINECS or in the European List of Notified 
Chemical Substances (ELINCS), the EC chemical substance directory that succeeded the EINECs 
directory, and imported into the European Commun ities as part of finished cosmetic products could 
not qualify for "phase-in substance" status.  As a result, many cosmetic ingredients used to 
manufacture products in the European Communities eith er would be considered as already registered 
under REACH, thereby avoiding costly REACH regist ration fees and procedures, or would be eligible 
for pre-registration between 1 J une 2008 and 1 December 2008. In eith er case, such substances would 
be considered "phase-in" substances and benefit from transition periods of  3, 6 or 11 years. 
44. The representative of the United States stressed that, by contrast, the same treatment would 
not apply to many ingredients used in imported cosmetics, as these were not included on either 
EINECS or ELINCS listings since this was not requi red under the relevant EC directives.  Thus, many  G/TBT/M/45 
 Page 9 
 
 
  substances in imported cosmetics would be consid ered "new substances" under REACH, despite the 
fact that they had legally been on the EC market in finished cosmetics for years.  Therefore, if those 
substances would be imported into the European  Communities in finished cosmetics in quantities 
above one ton annually per manufacturer or importe r, non-EC cosmetics producers would have had to 
register them by 1 June 2008 for th em to be considered legally on th e EC market, that is, without the 
benefit of the transitional periods.  Additionally, it was noted that non-EC manufacturers, seeking to 
register many substances that would be considered  new substances, would not  benefit from the data 
sharing provisions in Articles 27 and 28 and, in many cases, would be obliged to perform additional 
or duplicative testing, including potentially anim al testing, which would undermine what the US 
understood to be one of the primary tenets of REACH. 
45. The representative of the United States noted that US producers shipped approximately 
US$2 billion worth of cosmetics to the EC market each year, and that trade was being disrupted, and 
urged the European Communities to rectify the situation promptly.  It was pointed out that the European Communities had already recognized th at REACH could discriminate against foreign 
cosmetics producers, and had promised to provid e legal certainty that non-EC cosmetics producers 
would be able to pre-register their substances, par ticipate in the SIEFs and c ontinue shipping into the 
EC market.  Despite such assurances, the 1 June 2008 deadline had passed and companies still had not 
received word from the European Commission, exce pt for an ambiguous press release, which would 
not provide such certainty.  Therefore, the Eur opean Commission was encouraged to publish an 
amendment or corrigendum to REACH or provide a binding legal opinion that the ingredients in imported cosmetics qualify as phase-in substances under REACH.  
46. Finally, with respect to the implementation of REACH, the representative of the United States 
urged the European Communities to take into cons ideration the concerns which had been expressed 
by its trading partners and other interested parties,  and to ensure a meaningful opportunity to reflect 
the views of other governments and stakeholders in the process.  He stressed  that discussions between 
EC technical experts and their counterparts in the United States and other countries would continue in 
the TBT Committee process and through bilateral channels. 
47. The representative of Korea
 echoed the concerns already raised by other Members.  Several 
questions remained about the pre-registration pr ocess.  Therefore, Korea urged the European 
Commission to publish the technical guidelines for pr e-registration and give fu rther clarification on 
some specific issues which were yet unclear to the Korean industry.  For example, it was unclear if 
non-EC manufacturers could undertake pre-registration by appointing an Only Representative, even in 
the case they did not export chemicals directly to the European Communities.  Moreover, Korea 
encouraged the European Commission to clarify which actor would have priority if non-EC manufacturers and importers wished to make a pre-registration of the same substance.   
48. The representative of Cuba
 reiterated his delegation's positio n already expressed at previous 
meetings, and shared the concerns that had been ra ised by other delegations, in particular regarding 
the need to provide special and differential treatme nt to developing countries and technical assistance 
from European experts. 
49. The representative of Canada  noted that his delegation supported the objectives of protecting 
health and the environment.  However, she re iterated the concerns already expressed by other 
delegations and raised some specific questions con cerning REACH.  On the subject of fees, Canada 
noted that SMEs had expressed the concern that discounts on registration fees offered were small.  
Yet, due to the use of outdated definitions for de termining size, medium sized firms would not have 
benefited from reduced fees because under the fee stru cture, they would be considered large and not 
eligible for discounts.  Therefore, the representa tive of Canada asked the European Commission to 
explain whether the European Communities meant to  readjust the thresholds for determining the 
eligibility of a company to benefit from discounts on registration fees. G/TBT/M/45 
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  50. With respect to the issue of the Only Repr esentative, Canada encouraged the European 
Communities to clarify who could appoint an Only Representative and whether the European Commission was reviewing the requirements regardi ng the amount and types of confidential business 
information which non-EC firms were expected to pr ovide to their Only Representative.  In addition, 
the representative of Canada encouraged the Eu ropean Communities to update the Committee on EC 
parliamentary discussions concerning the adoptio n of the Globally Harmonized System (GHS) 
Regulation.  Similarly, she urged the European Commission to explain which areas of the GHS would be implemented and what the time line for implementation would be.  
51. Finally, Canada invited the European Commis sion to provide further information on which 
test methods would be adopted to classify chemical s under REACH.  In particular, she asked whether 
the test methods would be based on OECD standards or on EC acceptance processes, and what the 
practical consequences of such a choice would be.  
52. The representative of South Africa
 joined the concerns already expressed by previous 
speakers, particularly on the pre-registration process and on the burden on SMEs.  He pointed out that 
industry in his country found it very difficult  to understand what was required under REACH 
requirements and requested the European Comm unities to provide more technical assistance. 
53. The representative of the European Communities  appreciated the comments made on REACH 
and stressed that they would be transmitted to th e competent authorities.  She pointed out that the 
obligation to register under REACH had entered into  force on 1 June 2008, therefore industry was still 
able to send registration dossiers and pre-regist rations which allowed companies to benefit from 
extended registration deadlines.  It was recalled th at 1 December 2008 was the end of pre-registration 
deadline.  It was also noted that 7360 pre-regist rations had been received after two weeks of the 
entering into force of the registration obligation by  the European Chemical Agency and almost 1,500 
companies had signed up. 
54. With respect to the issue of the Only Repr esentative, the representative of the European 
Communities drew the Committee's attention to the fact that the guidance documents on registration 
had been modified.  In particular, it had been clar ified that in cases where Only Representatives would 
represent more than one non-EC manufacturer, they  must submit a separate registration submission 
for each of the non-EC manufacturers represented (p er substance).  Moreover, it was added that a 
subsequent update would further clarify the issue,  explaining the possibility for non-EC manufacturers 
appointing an Only Representative to cover in the registration submission also those quantities of substances that are sold to downstream users outsi de the European Communities in order to make a 
preparation, a polymer, or an article that was later imported in the European Communities.  With 
regard to questions on the possib ility of changing the Only Representative, the representative of the 
European Communities noted that a transfer of the registration would be possible by submitting an update of the earlier dossier.  She further clarified that the former Only Representative would have to 
agree with the change and that it would therefore be advisable that these aspects were covered in the 
private arrangements between the non-EC manufactu rer and the Only Representative. It was recalled 
that the Guidance documents were all available on the ECHA website
4 and that that the Only 
Representative system was not an obligation, bu t a possibility given to non-EC manufacturers. 
55. It was also noted that the issue of Small a nd Medium Enterprises (SMEs) was a key concern 
during the legislative process of REACH.  The re presentative of the European Communities explained 
that the registration required less information for lower tonnage ranges and significant reductions for 
SMEs had been foreseen by the Regulation on Fees.   Such advantages would be equally applied to 
SMEs based both inside and outs ide the European Communities. 
                                                      
4  http://reach.jrc.it/guidance_en.htm   G/TBT/M/45 
 Page 11 
 
 
  56.  On the issue of fees regulation, the repr esentative of the European Communities drew the 
Committee's attention to the document s ubmitted in this regard on 29 April 2008 
(G/TBT/N/EEC/52/Add.5)5, which set out the level of fees and charges under REACH.  It was 
recalled that the level of fees and charges had been  set taking into account the workload necessary for 
the processes to be managed by the European Chem ical Agency, and that fees and charges applied 
equally to EC-manufacturers and Only Representa tives of non-EC manufacturers.  Reductions up to 
90 per cent would be applied to SMEs.  The repr esentative of the European Communities also noted 
that Annexes IV and V of REACH, which exempted  certain substances or groups of substances from 
the obligations laid down in the registration, we re being reviewed.  The amendments would be 
communicated to the WTO in a draft stage. 
57. With regard to the questions on the candidate  list, the EC representative clarified that 
substances of very high concern would be identifie d and included in the candidate list according to the 
procedure established in Art. 59 of REACH.  It was also stressed that interested third parties could 
comment the process of identification and listing of s ubstances, as set out in Title VII, Chapter I of 
REACH. 
58. On the issue of cosmetics, the European Co mmunities stressed the importance of facilitating 
compliance with REACH obligations by all economic ope rators concerned.  In this regards, a press 
release published by the European Chemical Agency (ECHA) in the beginning of June had invited manufacturers or importers of substances that were la wfully on the EC market before 1 June 2008, but 
which did not have phase-in status under REACH, to contact ECHA.
6 
59. It was also noted that REACH did not regulate the formation of consortia.  However, work 
developed in a consortium before  the constitution of the Substan ce Information Exchange forum 
would be part of information that would have to be exchanged within the forum. 
60. With respect to the request for clarification on the discussions regarding the adoption of the 
proposal for a Regulation on the incorporation of  the Globally Harmonized System, Members were 
informed that the Commission had adopted the prop osal on 27 June 2007, that the proposal was still 
being discussed in the European Parliament and th e Council, and that the adoption and publication 
was expected by end of 2008. 
61. On the issue of uniform interpretation across the European Communities, the EC 
representative recalled that the legal instrument adopted for REACH was a regulation, which was 
directly applicable in all member States and applied uniformly throughout the European Communities.  The European Commission was cl osely monitoring the coherent and uniform 
application of REACH throughout the EC member States.  The dissenting views published on ECHA 
website were not part of the guidelines, but were for information only.  However, it was noted that 
only the text of REACH was legally binding and only  the European Court of Justice would have the 
competence to provide a definitive interpretation of its provisions. 
62. On the issue of monomers in polymers, th e representative of the European Communities 
recalled that the case was still pending at the European Court of Justice.
7 
63. The representative of the European Commun ities emphasised that the Commission and 
ECHA had made considerable efforts to provide gui dance and explanatory tools to help industry, 
                                                      
5 The text of the fees regulation is also available on the website of ECHA: http://ec.europa.eu/echa/  and 
at: http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2008:107:0006:0025:EN:PDF   
6 The press release can be found under: 
http://echa.europa.eu/doc/p ress/PR_08_12_Received_Subm issions_Inquir y20080609.pdf  
7 Case C-558/07. G/TBT/M/45 
Page 12  
 
  including from third countries, in complying with RE ACH.  She drew the Committee's attention to the 
workshop held in Brussels
8 and to the continuous work of the ECHA and REACH helpdesks.  
64. On the missing reply to the queries of Argentin a, the EC representative confirmed that the 
European Communities had received several letters  from the Argentinean government on REACH.  
Those letters had been sent to various department s of the European Commission. Where the letters 
had not been sent to the departments directly responsible for REACH, it took time to ensure 
translation, reattribution and coordination of replies to all letters received.  However, a comprehensive 
reply to all outstanding letters had been sent on 27 June 2008. 
65. For specific technical assistance to third countries, the EC representative recalled the 
intervention of the representative of UNIDO at th e last TBT Committee. The representative of the 
European Communities invited Members having specific needs for such technical assistance 
programs, to direct their requests to the respectiv e delegations of the European Commission in their 
country. 
(ii) European Communities – Produc tion and Labelling of Organic Products (G/TBT/N/EEC/101 
and Add.1) 
66. The representative of Argentina  reiterated his delegation's conc erns with respect to the EC 
regulation on production and labe lling of organic products, and drew  Members' attention to two 
documents submitted in this regard (G/TBT/W/ 284 and G/TBT/W/291).  Argentina was concerned 
with the Regulation 834/07, which had been notifie d to the TBT Committee in February 2006.  In 
particular, Article 24 of the regulation stated that the label of an organic product should contain an 
indication of the origin of the raw materials, taking one of the following three forms: (i) "EU 
Agriculture", when raw materi als originated from the Europ ean Communities; (ii) "non-EU 
Agriculture", when raw materials did not orig inate from the European Communities; and (iii) 
"EU/non-EU Agriculture", when part of raw mate rials originated from the European Communities 
and part from third countries.  Moreover, it was also  allowed to mention directly the country where 
the raw materials were obtained.   
67.    It was highlighted that such a compulsory identification of origin for products processed in 
the EC territory was not necessary in order to avoi d the risk of misleading European consumers on the 
qualities of an organic product.  In fact, to be c onsidered as organic, the quality of raw materials was 
already guaranteed by the fulfilmen t of EC requirements.  It was stressed that the requirements 
proposed in the draft EC measure could give c onsumers false impressions.  In addition, the 
representative of Argentina pointed out that the regulation was neither supported by WTO 
Agreements nor by Codex standards and could theref ore be considered as inconsistent with existing 
multilateral commitments. 
68. The representative of the European Communities  noted that Argentina had referred to the 
provisions of Article 24 of Regulation 834/07 on the labelling of organic products, with the particular 
concern that the processed products which contai ned raw materials from non-EU countries would 
have to carry the label "EU/non-EU Agriculture".   Her delegation informed Argentina that the 
European Commission had adopted a proposal which would postpone the application of Article 24 
until 2010  with a view to selecting a new EU organic logo before it became mandatory; therefore, 
Article 24 would not enter into force in January 2009 as had initially been foreseen. 
                                                      
8 Web-stream available at http://ec.europa.eu/enterprise/reach/events_en.htm#video    G/TBT/M/45 
 Page 13 
 
 
  (iii) European Communities – Regulation on Certai n Wine Sector Products (G/TBT/N/EEC/15, 
Corr.1-2 and G/TBT/N/EEC/57) 
69. The representative of Argentina  reiterated his delegation's con cerns with regard to the EC 
approach to wine labelling, as reflected in Regulation 753/2002 and in the amending Regulation 
316/2004.  In particular, the representative of Ar gentina remained concerned that EC standards 
granted EC member States an exclusive right to  use the traditional expression "para el Reino de 
España".9  In fact, it was stressed that there were no legal bases for the protection of such expressions 
under the Agreement on Trade-Related aspects of Inte llectual Property Rights (TRIPS), as this was 
not protected as a Geographical Indication (GI) unde r the Article 22 or the Article 24.6 of that 
Agreement.  
70. The representative of Argentina also recalled that at the EC level there was no common 
definition of such complimentary labels; rather, they originated from diverging legislations of 
different EC member States.  He noted that, sin ce there was no single definition for those traditional 
expressions at the EC level, it was impossible for non-EC States to comply with the requirements requested for the certification.  In any case, Arge ntina stressed that the Eu ropean Communities could 
not use a unilateral standard to exclude the use of those expressions by third countries.  Therefore, 
Argentina asked the European Communities to amend Regulation 753/2002 and Regulation 316/2004, 
which, in their view, were inconsistent with th e Article 2 of the TBT Agreement and could create 
unnecessary barriers to trade. 
71. The representative of the United States
 shared Argentina's concer ns regarding the European 
Communities' efforts to restrict severely the ability of non-EC wine producers to use common or 
descriptive and commercially valuable terms used on wine labels all over the world, on the grounds 
that those terms would have been traditional to Euro pean procedures.  Furthermore, it was noted that 
the European Communities appeared to be trying to claim exclusive rights in such terms, asserting 
that the use of these terms in connection with wine th at – in the view of EC officials – did not follow 
traditional production methods or met other criteria th eoretically associated with such wine would be 
deceptive or confusing for consumers.  However, despite repeated requests from third countries, the 
European Communities had never presented any evid ence of consumer confusion or deception with 
the current use of such terms by foreign wines on the EC market.  
72. It was the United States' understanding that th e European Communities wanted exclusive use 
of the above-mentioned terms by EC producers except  under certain limited circumstances where the 
third country would have regulated the terms to the satisfaction of the European Communities.  In this 
regard, the representative of the United States encour aged the European Comm ission to consider the 
concerns expressed by Members with the curre nt regulation when it published implementing 
regulations on traditional terms later in 2008.  
73. The representative of Canada  shared the concerns already ex pressed by the previous speakers. 
74. The representative of New Zealand  supported the comments made by other delegations and 
encouraged the European Commission to take into account the concerns expressed by third countries 
with the existing regulation when developing th e detailed rules for implementing the new common 
market organization for wine.  Her delegation looke d forward to being consulted in that process. 
75. The representative of the European Communities  confirmed that a new common market 
organization for wine had recently been adopted but  the implementing rules had not been developed 
yet; these would be notified to the WTO at an appropriate time.  She stressed that the regulation at 
issue already contained some provisions on labelling and use of geographical indications which would 
                                                      
9 In English: "for the Kingdom of Spain". G/TBT/M/45 
Page 14  
 
  simplify and clarify those in force.  For example,  the new labelling provisions, which would be further 
detailed by the implementing rules, would apply to both categories of wine, with or without a geographical indication (GI) and only introduced significant modifications in respect of GIs.  With regard to the point raised by the delegate of Ar gentina in respect of a consignment which had been 
detained in customs due to incorrect labeling under the current rules, the representative from the 
European Communities clarified that the use of certain traditional expressions was protected under 
EU law in so far as they related to a given la nguage and to a specific category of wine.  Third 
countries could therefore freely use these expressions for all the other remaining wines.  It was, 
however, imperative that a request was made by that third country according to Article 24 of 
Regulation 753/2002.  It was pointed out that, in this  vein, South Africa had filed an application and 
was exporting wines to the European Communiti es labelled with the Spanish expression "Vino 
Fino"
10, being a traditional expression which was protect ed in the European Communities for three 
types of Spanish wines.  Therefore, the EC repres entative invited Argentina to submit an application 
according to Article 24 of Regulation 753/2202. 
(iv) European Communities – Dangerous Chemical  Substances; Draft Commission Directive 
amending Council Directive 67/ 548/EEC (G/TBT/N/EEC/151) 
76. The representative of Colombia  expressed his concerns with regard to the 30th Adaptation to 
Technical Progress (ATP) to the Dangerous Subs tance Directive 67/548/EEC, and introduced a 
submission to the TBT Committee (G/TBT/W/288).  Co lombia did not consider either the responses 
provided by the European Communities regarding the concerns raised by various delegations at the 
most recent TBT Committee meetings, or the res ponse provided bilaterally a nd which concurred with 
those provided to other interested parties, to have allayed concerns or to have explained satisfactorily 
the justification and reasons for the classificati on of a group of nickel carbonates and related 
substances as dangerous substances. 
77. The representative of the Dominican Republic  associated his delegation with comments made 
by Colombia, and in particular reiterated concerns on the proposed re-classification of nickel 
carbonates and other components of nickel, which her delegation considered to lack sufficient 
scientific evidence.  She also noted that the comments expressed by various delegations at the 
meetings of the TBT Committee on 20 March 2008 had not been taken into account for the 
amendment of Directive 67/548/EEC.  It was her delegation's view that, having been adopted in these circumstances, the above-mentioned directive did no t satisfy the requirements of Article 2.9 of the 
TBT Agreement. 
78. On the other hand, the representative of the Do minican Republic welcomed the provisions of 
the above-mentioned directive which allowed for rec onsidering the classification of nickel if proper 
justifications were submitted, and encouraged the European Communities to give further information 
on the application of these provisions.  Moreover, she recalled that nickel exports represented, in 
2007, more than 50 per cent of the total exports of the Dominican Republic and that the proposed 
directive would have a negative effect on industry and the economy of the country as a whole.  In 
concluding, she expressed her de legation's concerns with regard to the project of the 31
st amendment, 
which would include the reclassification of 140 a dditional chemical compounds, and therefore urged 
the European Communities to no tify such amendment to the TB T Committee prior to its final 
adoption, so that comments from Members could be  taken into account and necessary modifications 
made. 
79. The representative of Cuba  shared the concerns expressed by previous delegations.  Her 
delegation regretted that the European Communities had adopted the 30th ATP to Directive 
67/548/EEC without taking into account either the concerns previously expressed by Members of the 
                                                      
10 In English: "Fine Wine".  G/TBT/M/45 
 Page 15 
 
 
  TBT Committee, or the arguments contained into the joint letter sent by a number of Ambassadors to 
the EC commissioners of trade and environment on 12  March 2008.  Furthermor e, Cuba also regretted 
that the provisions on special and differential treat ment in the TBT Agreement did not seem to have 
been taken into consideration, in particular Artic le 12.3, which provided that Members should take 
into account the special needs in the area of deve lopment, finance and trade of developing countries 
when preparing technical regulations, so as to en sure they are not creating unnecessary obstacles to 
exporters.   
80. The representative of Cuba recalled that th e new classification of nickel carbonates as 
hazardous substances did not have a scientific basi s.  She emphasized that the comparison between 
nickel borates and nickel sulphate seemed to be  unfounded, and urged the European Communities to 
carry out further studies on the matter.  It was also  stressed that researchers on cancer would not adopt 
any position on the carcinogenic affects of nickel soluble components until March 2009.  Moreover, 
Cuba noted that the proposed modified 31st ATP to Directive 67/548/EEC should have been notified 
earlier.  She considered that the EC amended Dire ctive was not in line with Article 2 of the TBT 
Agreement, as it limited trade more than n ecessary to achieve the pursued objectives.   
81. It was also stressed that nickel exports repr esented an important part  of Cuban exports, and 
that the new classification would have negative im pacts both on the nickel industry and industries 
which used nickel in their production such as the automotive, electronic and aviation industry.  In 
concluding, the representative of Cuba invite d the European Communities to revise the new 
classification for nickel carbonates in light of th e comments and concerns expressed, and urged the 
European Communities to notify the 31st ATP within due time. 
82. The representative of Brazil  expressed his concerns with regard to the decision of the 
European Communities to adopt the 30th ATP without taking into account either the request by 
various Members of the TBT Committee to postpone its adoption until there was scientific evidence 
on the actual risk posed by nickel compounds, or the study presented by the industry that had brought new elements indicating that the proposed classification for nickel compounds could be based on 
wrong assumptions.  It was pointed out that in this case the European Communities had adopted a 
disproportionate approach classifying nickel carbonates as a proven human carcinogen although there was no sound scientific evidence supporting this decision. 
83. Bearing in mind that Article 2.2 of the TBT Ag reement stated that regulations should not be 
more trade restrictive than necess ary to fulfil a legitimate objectiv e, Brazil invited the European 
Communities to review the classification of nickel carbonates under the 30
th ATP, and not to extend 
the Category 1 classification to nickel compounds under the 31st ATP until the results of the studies 
conducted by the industry could be analysed.   
84. The representative of Canada  pointed out that her delegation attached great importance to this 
issue.  Canada was the world's second-largest produ cer and exporter of nickel  and related substances 
and had a major interest in ensuring that the EC measures did not entail unnecessary barriers to trade.  
Her delegation regretted that the European Communities had adopted the 30th ATP despite the many 
concerns raised at the WTO and in other fora by several of the EC's trading partners.  Canada was 
further concerned that the European Communiti es did not provide any information on the 30th ATP 
before adoption, despite the information provided by the nickel industry that the EC's proposed 
classification for nickel carbonates was not based on sound scientific analysis.  She was concerned 
that a dangerous precedent for a large number of as sessments to be performed under REACH could be 
set. 
85. Canada noted that industry had begun to submit scientific information, including the report of 
The Weinberg Group on the issue of "read-across methodology". More scientific information was 
expected in 2008 and by mid-2009, and such info rmation should have been considered by the G/TBT/M/45 
Page 16  
 
  European Communities before adopting the 30
th ATP.  The representative of Canada welcomed the 
new recital to the adopted 30th ATP which stated that the classification would be reviewed as soon as 
new scientific information was available; she sought  further clarification on the implementation of 
this provision.  She also encouraged the Europ ean Communities to provide precise dates for official 
publication of the 30th ATP, and if changes were made, to provide copies of the version that would be 
published.  She stressed that Canada was not taki ng a position on the toxicity or carcinogenicity of 
particular nickel-based substances; rather, it was the process by which the European Communities had 
reached its conclusion that was of concern.  Sh e expressed her delegation's request that such 
assessments be scientifically based  and conducted in an appropriate  manner and urged the European 
Communities to ensure that any measures taken to protect human and environmental health 
represented the least trade restrictive options available, in conformity with Article 2.2 of the TBT 
Agreement.   
86. With respect to the notification of the draft 31st ATP, it was Canada's understanding that the 
European Communities intended to notify the 31st ATP at the same time that it would be circulated to 
EC member States for consideration.  Canada welc omed this decision and encouraged the European 
Communities to continue to notify all of its new measures in sufficient time to allow comments by 
Members to be taken into consid eration.  Moreover, it was her delegation's understanding that the 31st 
ATP Directive would contain further nickel classi fication proposals.  Therefore, she requested the 
European Communities to clarify the status of the 31st ATP and explain how the new recital in the 30th 
ATP would impact the 31st ATP.  The representative of Canada also requested that the 31st ATP be 
withdrawn or at the minimum that its implementa tion be delayed; that scientific data submitted by 
industry be analyzed; and, that the delay in a doption allow sufficient time for information submitted 
by industry to be properly considered. 
87. The representative of Australia  reiterated her concerns, as expr essed in the written response to 
the European Communities in January 2008 and at  the TBT Committees held on 9 November 2007 
and 20 March 2008, regarding the EC's recl assification of nickel carbonate under the 30th ATP and 
with the EC' s proposed reclassification of more than 140 other nickel compounds under the draft 31st 
ATP.  She stressed that the EC proposed reclassification of nickel substances under the 30th ATP 
would have a significant economic and commercia l impact on all nickel producing and exporting 
countries like Australia, including developing countries.   It was also pointed out that the potential 
economic impact was even greater with respect to the draft 31st ATP.   
88. Her delegation regretted that the European Communities had adopted the 30th ATP without 
taking into account the concerns previously expresse d by Members of the TBT Committee.  In this 
context, Australia noted that Article 2.9.4 of the TBT Agreement stated that if a technical regulation 
could have a significant effect on trade of othe r Members, the introducing Member should "allow 
reasonable time for other Members to make comments in writing, discuss these comments upon 
request, and take these written comments and the r esults of these discussions into account".  It was 
recalled that Australia had stressed the importan ce of ensuring a high standard of protection for 
human health and safety, and for the environmen t, and supported the development of regulatory 
strategies to achieve such protection.  Howe ver, in accordance with Article 2.2 of the TBT 
Agreement, these regulations should not create unne cessary obstacles to international trade.   
89. Concerns remained on the process by which the European Communities had assessed nickel 
carbonates, and on the lack of verification that nickel carbonates and the reference chemicals were 
sufficiently comparable to support the conclusions reached.  The representative of Australia stressed 
that her delegation was not taking a position on the toxicity or carcinogenicity of nickel carbonates; 
rather, it was seeking a sound, defensible and transp arent science-based approach.  It was also recalled 
that her delegation did not oppose the use of "read-across methodology" if applied correctly and in a robust and scientifically valid manner.  However,  Australian authorities had reviewed the scientific 
literature available on the issue, including EC and OECD documentation, and had concluded that  G/TBT/M/45 
 Page 17 
 
 
  there was no reliable data on the carcinogenic potentia l of nickel carbonates, that the use of "read-
across methodology" should be based on groupings of substance which were robust and scientifically 
valid and that solubility in water alone was an insufficient criterion on which to base "read-across 
methodologies".   
90. The representative of Australia remained concerne d that the EC approach to the nickel group 
could create a precedent for the manner in which ot her groups of chemical substances would be 
classified in future, including under REACH.  In fact, it was her delegation's understanding that 
Annex VI of the Proposal for a Regulation of th e European Parliament and of the Council on 
Classification, Labelling and Packaging of S ubstances and Mixtures and amending Directive 
67/548/EEC and Regulation (EC) No 1907/2006 (the  CLAP Regulation) would include harmonized 
classifications, including those of the 30th and 31st ATP, and those coming from REACH, via an ATP 
procedure.  This would create a precedent, and he r delegation was concerned about the scientific and 
procedural grounds of this precedent.   
91. Australia welcomed that the European Comm unities added a new recital to the adopted 30th 
ATP which stated that the classification would be  reviewed as soon as new scientific information 
would be available, and encouraged the European  Commission to take into account the additional 
scientific information from industry which woul d be ready in 2008 and by mid-2009.   
92. In concluding, the representative of Australia sought clarification about EC plans for the 
adoption of the 30th ATP.  She invited the European Comm unities to clarify when the decision to 
adopt the 30th ATP would be formally published,  and sought assurances that the 31st ATP would be 
notified under the TBT Agreement prior to its ad option, providing a reasonable period of time in 
accordance with Article 2.9.4 of the TBT Agreement. 
93. The representative of Japan  shared the concerns of previous speakers, in particular with 
regard to the classification of nickel.   
94. The representative of China  agreed with previous speakers and regretted that the European 
Communities had not fully addressed the concerns previously expressed by Members on the draft 30th 
ATP.  China asked the European Communities to c onsider the impact of the classification and the 
labelling of nickel carbonates and other nickel compounds on downstream industries.  It was noted that nickel carbonates and other nickel compounds would be categorized as Substances of Very High Concerns (SVHCs) and be subject to application of authorization and forced substitution under the 
REACH Regulation.  Therefore, the representative of China invited the European Communities to 
reconsider the classification and labelling of nick el carbonates and other nickel compounds.  Finally, 
he urged the European Communities to comply w ith the transparency obligations in the TBT 
Agreement and notify the 31
st ATP. 
95. The representative of Chile  regretted that the European Communities had adopted the 30th 
ATP without taking into adequa te consideration the comments ma de by his delegation, especially 
with regard to the non-toxicity of borates.  Chile noted that the modifications which were proposed to 
be introduce in the Directive 67/548/EEC would fu rther complicate the way in which chemical 
substances were treated within the European Communities.  Chile noted that the European 
Communities added a new recital to the adopted 30th ATP indicating that the classification would be 
reviewed as soon as new scientific information woul d be available, and encouraged the European 
Commission to take into account all the scientific anal ysis carried out and to engage in a discussion in 
order to analyze the information provided.  Fina lly, the European Communities was requested to 
notify any modification made at a later stage so as to provide an adequate period of time for 
considering comments from Members.  G/TBT/M/45 
Page 18  
 
  96. The representative of the United States
 shared many of the systemic concerns raised by 
previous speakers regarding the Eu ropean Communities' analysis fo r classifying nickel carbonates and 
other nickel compounds under Category 2 of the Dange rous Substances Directive.  In particular, the 
United States would have the same concerns with re gard to those classifications if the European 
Communities based its analysis solely on hazard, not  taking into account intended end uses of nickel-
containing products.  The US representative also associ ated himself with the c oncerns set out in past 
US statements and communications with respect to a related EC classification: the classification of borates under Category 2 of the Dangerous Substances Di rective.  In particular, he noted that the 
European Communities did not appear to have ta ken into account the normal handling and use of 
borates-containing products, when proposing its classification of borates, and that the European 
Communities acknowledged that its classification was entirely hazard-based and did not factor in the 
actual risks of exposure from intended end uses.  Th e representative of the United States reiterated his 
delegation's concerns regarding the skull-and-cr ossbones labelling requirements for certain borates-
containing products and the "knock-on"  effects under other EC legislation, including a ban on the use 
of borates in cosmetics, restrictions under the Ma rketing and Use Directive, and potential placement 
on the REACH authorization candidate list, of a Ca tegory 2 classification and the potential adverse 
impacts that this could have on the sale and trade of  borates and borate-contai ning products.  He noted 
that the EC approach to classification under the Da ngerous Substances Directive was of great concern 
to the United States, both in the case of borates and systemically.  Therefore, he regretted that the European Communities had finalized the 30
th ATP and, as a result, classified borates as a Category 2 
substance.   
97. Additionally, the United States representative noted  that the final classification determination 
contained language indicating that the European  Commission would take into account any new 
studies on borates that could become available, with  the possibility of re-eva luating its determination 
based on any such information in two years' ti me, and that the European Commission would conduct 
risk assessments before subjecting borates-containing products to restrictions under the Marketing and 
Use Directive.  He noted that the United Stat es would examine the determination when it was 
published.  However, it was his delegation's view th at a solution could be found that protected the 
health and safety of consumers while avoiding unne cessary restrictions on the sale and use of borates. 
98. The representative of South Africa  echoed the concerns already expressed on the adoption of 
the 30th ATP.  In particular, his delegation was c oncerned about the re-classification of nickel 
carbonates: the evidence on carcinogenicity of ni ckel carbonates was not scientifically based.  
Therefore, he requested the Eur opean Communities to adopt a transp arent science-based approach in 
the next 31st ATP. 
99. The representative of Turkey  joined the concerns expressed by other Members on the 
proposed classification of borates and nickel carbonates under the Directive 67/548/EEC.  As a leading producer and exporter of borates, Turkey r ecalled that, in addition to raising concerns in the 
last two TBT Committee meetings, his delegation had engaged in a bilateral dialogue with the 
European Communities and was among the Members that had submitted additional comments on the 
EC notification at issue.  In this regard, the Tu rkish representative thanked the European Communities 
for the replies received on 30 June 2008, but stresse d that the responses received did not fully satisfy 
the concerns expressed.  In fact, he regretted that the European Communities had adopted the 30
th 
ATP without taking into adequate consideration the comments made by  his delegation with regard to 
the classification of borates.   
100. In particular, Turkey believed that the cl assification had many procedural and scientific 
shortcomings and was not based on a legitimate obj ective, thus creating an unnecessary obstacle to 
trade.  The inclusion of a preamble indicating th e possibility of re-evaluating the classification of 
borates in the light of new scientific informati on was not considered to address the scientific 
shortcomings of the adopted classification.  In this regard, the European Communities was  G/TBT/M/45 
 Page 19 
 
 
  encouraged to clarify the matter and explain how and when it would reconsider its classification 
decision.  Additionally, the European Communities had also been invited again to  take part in a joint 
epidemiology study which would be conducted in Tu rkey's borate mines and manufacturing sites.   
The representative of Turkey invited the European  Commission to review its decision and comply 
with its obligations under the TBT Agreement. 
101. The representative of the Russian Federation (as an observer ) shared the concerns of previous 
delegations with regard to the nickel classificati on and stressed that her delegation attached great 
importance to this matter.  The Russian Federati on was one of the main producers of nickel and 
related substances and had a major interest in en suring that the EC measure did not entail unnecessary 
barriers to trade.  She therefore regretted th at the European Communities had adopted the 30th ATP.  
Attention was also drawn to the European Comm unities improper implementation of the "read-across 
methodology" prescribed by the OE CD Guidelines.  The proposed classification would have negative 
downstream consequences under the Globally Harm onized System (GHS) and REACH legislation. 
102. The representative of the European Communities  confirmed that the new Dangerous 
Substance Directive 67/548/EEC had been adopted  by the Commission on 9 June 2008.  The 
Directive would be published in the European Co mmunities Official Journal and transposed by the 
EC member States before June 2009; a copy of th e adopted text would be sent to the TBT Enquiry 
Point to the WTO.   
103. The European Communities informed the Member s that the new recital contained in the 
Directive 67/548/EEC read as follows: "The classificati on and labelling of the substances listed in this 
Directive should be reviewed if new scientific knowledge becomes available.  In this respect, 
considering recent preliminary, partial and not peer-reviewed information submitted by industry, 
special attention should be paid to further resu lts of epidemiological studies on the borates concerned 
by this Directive including the ongoing study conducte d in China and the outcome of the International 
Agency for Research on Cancer's discussion of th e classification of Nickel substances or any new 
relevant scientific findings or inte rpretations given to the data used  to establish the current proposals 
for the Nickel compounds concerned by this Directive". 
104. The representative of the European Comm unities confirmed that, following the TBT 
Committee held on 20 March 2008, industry had s ubmitted to the European Commission several new 
scientific studies, which had been examined w ith urgency by the Commission services and by the 
scientific experts from EC member States.  Indeed , the experts recognised unanimously that these 
studies were either incomplete or inconclusive; ther efore, they did not indicate that the proposed EC 
classification for those substances was inappropriate, nor did they signify a need to re-examine the 
classification that had been proposed.   
105. The EC representative drew the Committee's atten tion to the fact that sufficient time had 
already been dedicated at the last TBT Committee m eeting to discuss the questions brought by several 
delegations, in particular with respect to the h azard approach, the "read-across methodology" and the 
end uses, and referred Members to the detailed r esponses provided by the European Communities in 
the Minutes of the Committee meetings or in the wr itten replies submitted to several Members.  She 
also recalled the objective and extent of the EC proposal: the substances covered by this proposal 
(over 800) would need to bear, as of 1 June 2009,  a label which aimed at informing those who 
handled these substances, that they should be handl ed with care. It was her delegation's understanding 
that this was the least trade-restrictive measure av ailable to convey such information to the people in 
contact with those substances, therefore in line w ith Article 2.2 of the TBT Agreement.  The EC 
representative recalled that the label would provide  information on the hazardous properties of the 
preparations, but this classificati on would not ban or  restrict the use of these substances on consumer 
end-products.  As indicated at the previous TBT Committee meeting, a risk assessment would need to 
be carried out before imposing any type of marke ting restrictions, or setting maximum exposure levels G/TBT/M/45 
Page 20  
 
  or bans.  Interested stakeholders and third countri es would be able to participate in this process and 
measures would be notified to the WTO at a draft stage. 
106. With regard to the requests of postponing the implementation of the 30
th ATP, the EC 
representative noted that the Dangerous Substan ce Directive 67/548/EEC required the European 
Commission to take measures to harmonise the classi fication of Carcinogens, Mu tagens or substances 
toxic to Reproduction (CMR) "as quickly as possible", also recalling that its adoption had already 
been postponed for a year.  Furthermore, she pointed  out that many of the arguments stressed by the 
industry were based on speculations, in particular  with regard to how these substances would be 
treated under REACH.  She stressed that there wa s no direct link between the classification of a 
substance and the authorization process under REACH,  and also noted that the candidate list of 
substances classified as of high concern and the list of  substances which would be classified in the 31st 
ATP had not even been drafted.  In concludi ng, the European Commission informed the Committee 
that the draft 31st ATP would be notified to the WTO at the time that it was submitted to the EC 
member States, and confirmed its willingness to discuss any issues related to the implementation of the proposal. 
(v) United States – Chemical Facility Anti-Terrorist Regulation 
107. The representative of Israel
 reiterated his concerns with resp ect to the list of "chemicals of 
interest" (Appendix A), published by the US Depa rtment of Homeland Security (DHS) in the 
20 November 2007 Federal Register, that were subject  to the interim final DHS regulation on security 
of high-risk chemical facilities, published in the 9 April 2007 Federal Register.   
108. In particular, his delegation was concerned th at the DHS list of "chemicals of interest" 
included potassium nitrate and sodium nitrate, but did not include calcium nitrate.  Israel believed that 
the inclusion of potassium and sodium nitrate in th e list resulted in an unnecessary obstacle to trade 
and that the measure could affect Israel's exports to the US market.  Availa ble scientific information 
indicated that all three products were similar and ha d similar properties, and that they did not pose a 
security threat.  Therefore, they needed to be treat ed equally and not included in the DHS list.  His 
delegation was ready to consult with the United Stat es on the matter, preferably at an expert level, 
with the view of finding an agreed solution. 
109. The representative of Chile  shared the concerns expressed by Israel.  Concerns had been 
expressed about the exclusion from the regulation of n itrates such as alkaline nitrates, calcium nitrates 
or magnesium nitrates, which had the same chemic al properties and competed with those products 
that had been included in the list of "chemicals of interest" (Appendix A).  It was stressed that other 
chemicals which had been excluded from the regulation, such as nitrates with ammonium, were 
elements of interest that could be used by terrori sts.  The representative of Chile noted that comments 
had been submitted to the United States  and that a response was awaited. 
110. The representative of the United States  recalled that, as Israel and Chile had indicated, both 
sodium nitrate and potassium nitrate were included in  Appendix A of this regulation, which contained 
the list of "chemicals of interest" covered by the me asure at issue.  Through a process of scientific risk 
assessment, as well as consultation with security au thorities in other countries and public notice and 
comment, DHS had determined that the Chemical Facility Anti-Terrorist Regulation (CFATS) would 
apply to a specific set of substances, including certain nitrates determined to possess the requisite 
precursor explosive properties  
111. It was highlighted that CFATS required handlers – for example distributors – of the chemicals 
contained in Appendix A to submit screening info rmation to DHS.  The screening information would 
be submitted in the form of a document called a "t op-screen", which handlers could submit through an  G/TBT/M/45 
 Page 21 
 
 
  on-line procedure.  DHS had already received comple ted "top screens" from nearly all of the covered 
handlers of the nitrates subject to CFATS. 
112. The representative of the United States noted that  Israel and Chile had conveyed concerns that 
the application of CFATS to nitrates would be bur densome and could encourage farmers to use other 
fertilizers.  However, his delegation believed that the available evidence did not support these views.  
DHS had estimated that the average time to co mplete the online "top-screen" information was 
27 minutes, and none of the major industry associati ons in the United States had reported that their 
members were encountering any problems with completing the top screen.  In addition, in 
January 2008 DHS had announced an open-ended exem ption for farmers and other agricultural users 
from the screening requirement contained in this  measure.  Moreover, the online "top-screen" was 
merely a questionnaire; only those facilities that DHS would subsequently determine as high risk 
would be subject to regulation. 
113. The representative of the United States noted th at bilateral discussions had been held with 
Chile on its concerns, including with DHS, and st ressed that his delegation would continue to 
facilitate information exchange with  trading partners, in order to en able their exporters to understand 
and comply with this new requirement.  He noted th at DHS was also planning to be in contact with 
exporters who may wish to serve on an industry advisory panel to provide advice to DHS as it 
implements CFATS. 
(vi) Sweden – Restrictions on the use of  Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/SWE/59) 
114. The representative of Israel  recalled that her delegation had raised concerns about the above-
mentioned measure several times.  The Committee's attention was drawn to the fact that the ban on 
the use of deca-BDE now concerned the whole of the European Communities.   She noted that deca-
BDE had been exempted from the "Restriction of Hazardous Substances" Directive (RoHS) following 
a risk assessment which had concluded that it did not represent any significant risk to health or 
environment.  However, on April 2008, the European Court of Justice had ruled that the exemption 
given for deca-BDE should be annulled by 1 July 2008 on the basis of procedural flaws in the 
exemption process.  As a result, deca-BDE would not be exempted from the ban within the RoHs 
Directive, and as of 1 July 2008 would be restricted from use in electronic and electrical equipment.  Israel considered this restriction an unnecessary obst acle to international trade within the meaning of 
Article 2.2 of the TBT Agreement.  He noted that  the RoHS Directive was being reviewed and urged 
the European Communities to exclude deca-BDE from its scope. 
115. The representative of Jordan
 noted that the EC risk assessment which had been published in 
the Official Journal of 29 May 2008 concluded that  no risk had been identified for the use of deca-
BDE.  However, the use of deca-BDE was restricted  in the European Communities.  He stressed that 
the European Communities should consider a dopting a new exemption or removing deca-BDE 
entirely from the scope of the RoHS Directive.  Fa ilure to correct the situation would undermine the 
credibility and the usefulness of  risk assessments taking place, which would in turn undermine the 
scientific foundations of both RoHS and REACH.  
116. The representative of Japan  noted that his delegation's understanding was also that deca-BDE 
would now be reapplied to the RoHS Directive.   Since deca-BDE was produced in large amounts 
outside the European Communities, this had a consid erable impact on international trade.  He noted 
that this issue had not yet been notified to the TBT Committee and sought more  information from the 
European Communities.  
117. The representative of Chinese Taipei  associated himself with the comments made and noted 
that his delegation's understanding was that the recent assessment by the European Communities on G/TBT/M/45 
Page 22  
 
  deca-BDE was not based on scientif ic evidence, which did not ju stify the European Communities 
claim of protection of human health.  
118. The representative of th e European Communities
 explained that the Court of Justice had ruled 
on 1 April 2008 that the decision exempting deca-BDE from the scope of the Directive on the Restriction of the use of Hazardous Substances should be annulled, as the procedure which the 
European Commission had followed to grant such ex ception had not been carried out appropriately.  
Therefore, as of 1 July 2008, the use of deca-BDE would be restricted in electrical and electronic 
products placed on the EC market.  She pointed out that the European Commission was examining possible scenarios of addressing this matter with a view  to reducing the impact on exports from third 
countries and that any measure which the European  Commission proposed in this respect would be 
notified to the TBT Committee, if appropriate.   
(vii) Korea – Fish Heads 
119. The representative of New Zealand
 reiterated concerns about r estrictions in Korea on edible 
hake heads processed on New Zealand boats, which received different treatment compared to fish 
heads caught by Korean boats.  She recalled that Korean officials had announced that hake heads were 
going to be added to the national Food Code and that the matter would become relevant to SPS.  A 
significant amount of information on the safety of these fish heads processed by New Zealand boats had been provided to the Korean Ministry of Fish eries.  She pointed out that another delay had 
occurred and the changes to the Korean Food Code had not been made.  She sought the cooperation of 
Korea to ensure that the required changes to the Food Code were made so that the matter would not 
have to be raised again. 
120. The representative of Korea
 regretted that the issue had been raised again.  He informed the 
Committee that after the notification of its draft Food Code to the SPS Committee, the Korean Food 
Sanitation Council had decided to undertake a site inspection before enactment, which was due in 
May 2008.  He pointed out that Korea and New Zeal and were discussing a detailed plan of site visits 
by Korean experts.  
(viii) Brazil – Toys (G/TBT/N/BRA/259) 
121. The representative of Malaysia  recalled concerns about a Braz ilian notification on toys which 
had been raised by his delegation at the previous meeting of the Committee and pointed out that, since 
then, bilateral discussions had taken place with the Brazilian delegation on the issue and a written 
communication had been sent to Brazil.  However, no response had been receiv ed.  He reiterated his 
delegation's request to Brazil that the technical re gulation on toys be reviewed.  In particular, he 
requested Brazil to accept the results of conformity assessment procedures of accredited conformity 
assessment bodies, without requiring the testing of Malaysian products to be  conducted in Brazil.  
Additionally, both systems 7 and 5 certification pr ocedures should be made available to Malaysian 
exporters. 
122. The representative of Thailand  recalled that at the previous meeting of the Committee, her 
delegation had noted that the INMETRO Decree re sulted in unequal treatment for imports and was 
more trade restrictive than necessary.  However, her delegation was concerned that no changes had 
been made to the Brazilian measure, which required impor ted toys be tested by lots or batches.  This 
meant that the Brazilian regulation accorded less favourable treatment to imports in breach of Article 
5.1.1 and also created unnecessary obs tacles to trade in violation of Article 5.1.2, because it was more 
strict than necessary to give Brazil adequate c onfidence that imported toys conformed with its 
technical regulation on toy safety.  There were ot her WTO-consistent alternative measures available 
to Brazil, such as testing in the country of expor t, especially when such testing was conducted by 
internationally recognized and accredited laboratories.  She stressed that her delegation agreed with  G/TBT/M/45 
 Page 23 
 
 
  the objective to ensure that toys destined for children were safe.  Nevertheless, such measures had to 
be applied in an equal way.  She requested that the Brazilian Decree be brought into conformity with 
the TBT Agreement and that a written reply to comments sent be provided.   
123. The representative of th e European Communities  pointed out that concerns remained about 
less favourable treatment of imported toys compared  to domestically produced toys.  It was his 
delegation's view that the so called "system 5" pr ocedure, which was available only to domestically 
produced toys, was less burdensome than the so called "system 7" procedure which was available to 
imported toys.  The European Communities appreciat ed Brazil's willingness to enter into bilateral 
discussions but urged Brazil to consider measures wh ich would restore a level playing field between 
imported and domestically produced to ys.  He stressed that initial feedback provided by European 
Industry on the initial period of application of the new measures pointed to increasing delays for the 
release of imported toys into circulation in Brazil and to much higher costs compared to the previous 
regime.  In addition, there were concerns about th e abilities of the few test la boratories that had been 
agreed by INMETRO to perform the test required by the system 7 procedure. 
124. The representative of the Europ ean Communities further highlight ed that summer and autumn 
were crucial periods for shipment of toys in view  of the Christmas sales and that the difficulties that 
had been reported in the initial period of application of the measures were likely to be exacerbated in 
the coming months.  He invited Brazil to consider  measures that would allow equal treatment of 
imported and domestically produced toys  and to allow the recognition of results of tests carried out in 
the country of origin of the toys.   
125. The representative of China  pointed out that the Chinese industry had reported that, further to 
the introduction of the new testing process, an averag e of 70 days delay had been experienced.  This 
created a significant burden for China's exports of to y products.  He requested that Brazil ensure toy 
safety in a non-discriminatory and less trade restrictive manner and that the measures be brought into 
conformity with WTO obligations.   
126. The representative of Brazil  pointed out that the new conformity assessment procedures had 
been adopted under urgent circumstances and with th e legitimate objective of protecting the health of 
consumers.  The previous conformity assessment system had proved to be inefficient and several 
cases of non-conformity, recalls and accidents had been  reported in 2007.  He noted that these urgent 
measures were not permanent, and that the adoptio n of a new and definite system of conformity 
assessment procedures for toys was under considera tion by the competent authorities in Brazil. 
(ix) Germany – Ban on Seal Produc ts (G/TBT/N/DEU/5 and Add.1) 
127. The representative of Norway  reiterated concerns about the banning, by several EC member 
States, of imports of seal products, the most recent of which had been notified by Germany.  Her delegation believed that the ban on seal products was not an animal welfare issue, it was not a 
conservation issue and it was not a management issu e.  Rather, it was a public opinion issue, which 
was considered unsubstantiated and unjustified.  She stressed that ban on imports of seals in EC 
member States set a dangerous precedent for trade in animal products that were harvested in a 
sustainable and humane manner.  It was her delega tion's  expectation that the European Commission 
would notify any draft future regulations concer ning trade in seal products to the TBT Committee 
within the time limits of the TBT Agreement.  No rway continued to reserve its right to take any 
appropriate action necessary to defend its interest s under the TBT Agreement and other relevant WTO 
agreements. 
128. The representative of Canada
 reiterated that her delegation shared Norway's concerns on the 
ban of seal products by several EC member States.  Her delegation also believed that this was neither 
an animal welfare nor a public morality issue, but an issue of public opinion.   G/TBT/M/45 
Page 24  
 
  129. The representative of the European Communities
 pointed out that, as noted in the previous 
meeting of the Committee, the draft proposal had been notified to the European Commission under 
internal procedures and was currently bei ng examined by the Commission services.   
(x) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
130. The representative of the European Communities  recalled the concerns expressed by her 
delegation on the Indian measure and thanked Indi a for having notified the Order in April 2008.  
However, her delegation regretted that the Orde r had only been notified once it had already been 
adopted.  She stressed that according to Articles 2. 9.2 and 5.6.2 of the TBT Agreement, notifications 
had to take place at an early appropriate stage,  when amendments could still be introduced and 
comments taken into account.  
131. The representative of the European Communities pointed out that written comments would be 
sent to India shortly and that concerns remained about the burdensome requirements imposed on imported cosmetics. The Order laid down a registration system for imported cosmetics which discriminated against imported products, introduced  long delays before the products could be placed 
on the market, and required the disclosure of confid ential business information.  At the same time, it 
was difficult to see how this system would increase product safety, or would help curtail 
counterfeiting and parallel trade as intended.  The Eu ropean Communities was of the opinion that the 
Order was in many respects vague and did not set  clear rules for the registration procedure.  
Therefore, the measure was considered as more trad e restrictive than necessary and thus not in line 
with Article 2.2 and 5.1.2 of the TBT Agreement.  India was invited to continue the bilateral talks 
already initiated on this issue and to bring the me asure into conformity with the TBT Agreement. 
132. The representative of the United States
 reiterated his delegation's concerns regarding India's 
"Drugs and Cosmetics (Amendment) Bill, 2007," wh ich India had belatedly notified to the WTO in 
final form after the last Committee meeting.  Hi s delegation continued to  seek a better understanding 
of the objective and rationale of the new require ments, on whether the measure applied to all 
cosmetics entering the Indian market, not just imports, and specifically on how the registration 
requirements were expected to increase product safet y for consumers.  He noted that US industry's 
concerns had also been conveyed to the Indian au thorities, in particular the perception that the 
measure would be overly burdensome, and could result in costly delays to market for its products.  
133. The representative of the United States looked fo rward to a continued dialogue with Indian 
authorities on this issue, on the basis of the US co mments that had been submitted in early June and 
urged India not to require compliance with the re quirements until industry co ncerns, particularly on 
the applicability of the registration requireme nts to all cosmetics, were addressed.   
134. The representative of India  noted that constructive bilateral meetings had been taking place on 
this issue with the European Communities and the United States.  Some queries asked by the United 
States had been answered and new questions had also been raised; these would be transmitted to 
capital.  The forthcoming written comments fro m the European Communities would also be 
transmitted to experts in capital, and a duly examined .  He stressed that comments would be taken into 
account before enforcing the measure. 
(xi) China – Proposed Regulations on Information Security (G/TBT/N/CHN/278-290)  
135. The representative of the United States  reiterated his delegation's c oncerns related to China's 
above-mentioned measure notified to the TBT Co mmittee in August 2007.  These regulations would 
mandate a government certification and testing schem e for information security for 13 categories of 
information technology products.  He noted that, for the vast majority of IT products, other countries 
did not require government testing and certificati on for information security; this was only the case  G/TBT/M/45 
 Page 25 
 
 
  for a small subset used by governments for natio nal security purposes.  His delegation's general 
concern was that China's regulations appeared to  go substantially beyond global norms by mandating 
testing and certification of information security for commercial products.  He sought clarification 
from China regarding its rationale, and the technical information it considered, in seeking to extend 
certification and testing requirements to informatio n security for IT products used commercially in 
these 13 categories.   
136. In addition, many key aspects of the proposed technical regulations had yet to be explained 
and the scope of products covered remained unclear.  It was pointed out that the testing procedures 
that suppliers would need to utilize to demonstrat e conformity with the regulations had not been 
provided.  Moreover, provisions to ensure that intellectual property and other business proprietary 
information were protected by governmental author ities had not been promulgated.  In this regard, 
transparency in the development of such require ments would be of paramount importance.  The 
representative of the United States urged China to conduct a transparent process that allowed 
meaningful opportunity for comment and inquiries by a ll interested stakeholders.  He further recalled 
that his delegation had engaged Chinese authorities b ilaterally, suggesting that China delay finalizing 
the technical regulations to allow time to discu ss these technical issues in a constructive manner.  
China's willingness to engage in these discussions w as appreciated.  However, it was his delegation's 
understanding that CNCA had indicated to industry  that the technical regulations would soon be 
finalized and become mandatory for a ll covered products as of 1 May 2009. 
137. The representative of the United States noted that , in addition to the overall concern regarding 
the need for these regulations, it was difficult to see how they could be implemented on such a tight 
timeframe, given the critical details that had yet to  be specified.  If China continued to pursue these 
regulations, their finalization needed to be delaye d so as to enable parties to continue working 
constructively together to address the concerns that  had been raised in a manner consistent with 
international practice in this area.  
138. The representative of Japan  noted that in January 2008, IT security products had been added 
to the category of CCC system, which would come in to effect in May 2009.  Japan was concerned 
about the management of intellectual property. He also requested that China allow foreign 
certification bodies based in China or overseas to be  appointed, in accordance with Article 6.2 of the 
TBT Agreement and paragraph 195 of the Report of  the Working Party on the Accession of China. 
139. The representative of the European Communities  supported the statements made by the 
United States and Japan and highlighted a few issues of  concern.  First, he requested China to clarify 
the rationale for the proposed measures and their implications.  If the legitimate objective being 
pursued was that of national security, the European Communities found difficult to understand why it also applied to products intended for commercial and consumer use.  Moreover, his delegation was 
concerned about the expansion of the Chinese compulsory certification system (CCC) - considered a burdensome and expensive conformity  assessment procedure - to new product categories.  It was also 
not clear how the existing international standards (ISO/IEC 15408:2005), which set out the common 
criteria for information technology security evaluation,  had been taken into account in the preparation 
of the proposed measures.   
140. With regard to the practical implementation of the proposed measures, the representative of 
the European Communities joined th e comments made by previous dele gations and stressed that the 
procedures and modalities to have access to the unde rlying encryption algorithms had not been 
disclosed.  In particular, there were intellectual pr operty rights (IPR) related concerns with regard to 
the possible need for companies to  disclose sensitive commercial information.  In concluding, the 
representative of the European Communities encour aged the Chinese delegati on to start discussions 
both bilaterally and at an expert level with a vi ew to finding an agreed solution, and meanwhile 
invited China to consider suspending the adoption of the proposed measures. G/TBT/M/45 
Page 26  
 
  141. The representative of China
 noted that the proposed regulations aimed solely at protecting 
information security, and simplifying the current sy stem.  He took note of the comments and stressed 
that the concerns raised would be discussed with stakeholders. 
(xii) Argentina – Measures affecting Market  Access for Pharmaceutical Products 
142. The representative of Colombia  recalled that at the previous meeting of the TBT Committee, 
his delegation had expressed concerns with regard  to the system applied by Argentina for the 
commercialization of pharmaceuticals (G/TBT/W/280).  It was also recalled that some of the measures appeared to be contrary to rights and obl igations under the TBT Agreement.  He pointed out 
that no reply had been provided by Argentina on the concerns expressed; therefore, Colombia would 
consider making a formal complaint under th e Dispute Settlement Understanding (DSU). 
143. The representative of Chile
 recalled that her delegation had also expressed concerns on this 
issue in the previous meeting of the TBT Commi ttee.  Chile shared the concerns expressed by 
Colombia and noted that no reply had been received by Argentina.  
144. The representative of Paraguay  noted that concerns had also been expressed by his delegation 
in the previous meeting of the TBT Committ ee, and that no progress had been made.   
145. The representative of Argentina  recalled that there had already been contacts between the 
representatives of concerned Members and relevant au thorities.  In particular, it was noted that 
Colombian authorities had met with experts from Argentinean competent agencies on 11 April 2008, 
and as a result of this meeting an agreement on th e inspections required by laboratories was reached.  
With regard to the concerns raised by Chile and Paraguay, although consu ltations had been conducted 
on bilateral basis, Argentina remain ed convinced of the appropriaten ess of the measure at issue.  
Finally, Argentina invited concerned delegations to contact the relevant technical authorities for 
further clarification. 
(xiii) Brazil – Registration Requirements for Medical Devices 
146. The representative of the European Communities  reiterated her delegation's concerns with 
regard to the Brazilian registration requirements fo r medical devices introduced by Resolution 185 but 
not yet notified under the TBT Agreement.  Th e Resolution 185 required the submission of an 
economic dossier for each version and accessory of every product covered by the resolution.  The 
procedure required the submission of data which was extremely difficult for economic operators to 
provide, and in part was confidential business inform ation.  The regulation was therefore considered 
burdensome and not practicable.   
147. The European Communities appreciated Brazil's confirmation that the Agência Nacional de 
Vigilância Sanitária  (ANVISA) sought to ensure transparency  in the implementation of the measure, 
but economic operators were still facing several problem s.  In particular, it was not clear what would 
happen if the economic dossier was not submitted.  For instance, it was th e European Communities' 
understanding that if the dossier was not submitted w ithin 30 days after notice of approval of product 
registration, the product would not be able to be so ld.  Moreover, it was unclear what would happen if 
a dossier was incomplete, and when or how the submitting company would be informed about the 
evaluation of the dossier.  Finally, the representativ e of the European Commun ities stressed that the 
procedure of the resolution of disputes had to be cl ear, transparent and predictable.  She encouraged 
the Brazilian authorities to continue their exchange  of views with the economic operators, to provide 
replies to the concerns expressed and to consider further amending the resolution. 
148. The representative of the United States  appreciated Brazil's efforts to engage in a constructive 
dialogue on the concerns which had been raised in respect of the Resolution 185, and thanked Brazil  G/TBT/M/45 
 Page 27 
 
 
  for the detailed replies provided to industry stake holders on their recommendations to help clarify the 
information requirements contained in the Resolution.   He reiterated his delegation's view that the 
requirement to submit economic data was not related to the safety or efficacy of medical devices, and 
was unnecessarily costly and burdensome.  Furtherm ore, industry had indicated that some of the 
information required was impossible to provide, eith er because the information did not exist or could 
only be provided by contacting other companies to ob tain it, which raised potential antitrust concerns.  
It was also noted that such problems had already led ANVISA to deny commercialization for certain products. 
149. The representative of the United States noted that  ANVISA had been working with interested 
stakeholders and appeared to be in agreement with  the need for greater transparency and specificity 
with regard to adjustments in the reporting requireme nts, particularly given the difficulties associated 
with fulfilling the Resolution’s e xpansive information requirements.   However, Brazil still had not 
taken any official actions to clarify those requi rements for importers, and ANVISA seemed to be 
inviting suppliers to disregard in formational requirements contained in the Resolution that suppliers, 
in their own judgment, might feel were burdensome or  impossible to fulfil.  However, companies that 
did so would operate in the Brazilian market under conditions of great legal and economic uncertainty 
because such flexibility was not set out in the text of the Resolution and, in practice, ANVISA did not 
let companies know whether they had complied once th ey had submitted their data.  Such uncertainty 
had the potential to create unnecessary disruptions rega rding trade in medical devices, ultimately to 
the potential detriment of the Brazilian public.  Theref ore, the United States urged Brazil to continue 
working with interested stakeholders to clarify the informational requirements of the Resolution and 
provide legal certainty for the industry on how to comply with them. 
150. The representative of Brazil
 reiterated his delegation's pos ition that Resolution 185 was 
neither a technical regulation nor a conformity assessm ent procedure.  His delegation believed that in 
previous meetings Brazil had clarified why Reso lution 185 was not covered by TBT provisions and 
did not need to be notified to the TBT Committee; therefore, those points were not reiterated.   
(xiv) Norway – Proposed regulation concerning sp ecific hazardous substances in consumer 
products (G/TBT/N/NOR/17) 
151. The representative of Korea  took note of the fact that Norway was reviewing the comments 
concerning the proposed regulation on the Prohibition  of certain Hazardous Substances in consumer 
products (PoHS), which had been made at the last  TBT Committee.  His delegation looked forward to 
having updates on this issue.  In particular, it wa s stressed that there were no scientific bases to 
prohibit bis(2-ethylhexyl)phthalate (DEHP). 
152. The representative of Israel  supported the comments made by Korea, and recalled her 
delegation's concerns with respect to two chemic als of export interest to his country, namely: 
tetrabromobisphenol A  (TBBPA) and hexabromocyclododecane  (HBCDD). 
153. The representative of Jordan  noted that the entering into fo rce of the regulation was delayed 
and invited Norway to take into consideration hi s delegation's concerns with respect to the two 
chemical substances of interest to his country, namely: TBBPA and HBCDD.  
154. The representative of Japan  also expressed concerns about  the above-mentioned proposed 
regulation. 
155. The representative of the United States  noted his understanding that  implementation of the 
regulation had been delayed because of the many comments Norway had received from Members and 
that, in light of those comments, Norway had annou nced that the proposed measure might need to be G/TBT/M/45 
Page 28  
 
  revised.  The United States requested Norway to provide further information on how it would take 
into account the comments received in revising the proposed regulation. 
156. The representative of Norway
 confirmed that the above-men tioned regulation had not entered 
into force on 1 January 2008, as previously announ ced, and that the comments received were being 
evaluated by Norwegian environmental authorities.  Useful information concerning the application of 
some of the substances covered by the proposed  measure had been received.  Moreover, the 
Norwegian environmental authorities were holding m eetings with interested stakeholders.  Limit 
values for the different substances and possible exem ptions were being evaluated, with the aim of 
finalizing a decision in the first part of 2009.  Norway would inform Members on the progress of the regulation through regular procedures. 
(xv) Norway – Restrictions on the use of  Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/NOR/6, Add.1 and Corr.1) 
157. The representative of Jordan
 requested clarification on the implementation of the Norwegian 
regulation on Deca-bromo diphenylether (deca-BDE).  Although the proposed measure was expected 
to enter into force on 1 April 2008, many Members be lieved that the measure did not have sufficient 
scientific basis. 
(xvi) European Communities – Directive 2002/95/EC on the Restriction of the Use of certain 
Hazardous Substances in Electrical and Electronic Equipment (RoHS) (G/TBT/Notif.00/310, Corr.1) 
158. The representative of the United States
 drew the Committee's attention to the European 
Communities' on-going review of the Directive con cerning Restrictions of Hazardous Substances 
(RoHS), and recalled that several discussions had taken place in the Committee during the 
development and initial implementation of the original  directive, including regarding problems related 
to the lack of clear guidance and transparency.  He noted that the results of a recent study by a global 
association of electronics companies showed that in itial compliance cost associated with the original 
RoHS directive was US$32 billion.  The United Stat es was concerned about the magnitude of the cost 
of compliance and, in particular, the disproportiona te impact on Small and Me dium-sized Enterprises 
(SMEs). 
159. The representative of the United States emphasi zed that EC regulators should ensure a risk 
and science-based approach to the RoHS review , including evaluating whether to add additional 
substances to the list, set maximum concentration le vels for specific products, or grant exemptions.  
The European Communities was encour aged to provide clarity in a timely manner on how RoHS and 
REACH would fit together and to carry out a transp arent process, including a notification to the WTO 
of proposed changes or amendments to RoHS, that  allowed a meaningful opportunity for comment by 
all interested stakeholders.  Additionally, the United States requested the European Communities to 
provide a status report on how the RoHS direct ive was being enforced and how the European 
Communities intended to ensure a unified approach to enforcement across th e EC Member States.  
Finally, the European Communities was urged to pr ovide a reasonable period of time for suppliers to 
implement any changes made to the directive. 
160. The representative of the European Communities  confirmed that the RoHS directive was 
being reviewed.  One of the main objectives of this review was to clarify and simplify the provisions of the directive, to reduce the administrativ e burden and to address reported implementation 
difficulties.  In the review, the European Commi ssion would examine the need and possibilities of 
extending the restrictions to other hazardous subs tances and the exemptions granted under the RoHS 
directive.  It was noted that many companies a nd associations from third countries had contributed 
extensively to the consultation process.  The Eur opean Communities also info rmed Members that an  G/TBT/M/45 
 Page 29 
 
 
  Impact Assessment was underway and was expected to  be concluded by the end of July 2008.  The 
Impact Assessment would lead to the preparation of a proposal by the Commission which would be 
discussed internally, and subsequently notified to th e Committee.  In concluding, the representative of 
the European Communities emphasized that coheren ce with other product-related legislation as well 
as with REACH would be ensured, wherever appropriate. 
(xvii)  China – Draft Standards on Lithium Batteries for Mobile Phones 
161. The representative of Japan  recalled that at the last TBT Committee meeting his delegation 
had raised concerns with respect to China's draf t standards on lithium batteries for mobile phones and 
sought clarification on the current status of the draft.  He raised concerns on two specific points.  First, 
the representative of Japan pointed out that alt hough the standards on batteries should be based only 
on safety concerns, they included environment and effi ciency issues and were also applied to battery 
chargers.  Furthermore, he recalled that standards should be developed in cooperation with interested 
business sectors and should comply with relevant international standards.  Finally, Japan also 
expressed concerns about intellectual property matters.  
162. The representative of th e European Communities  supported the comments made by Japan, 
and thanked the Chinese authorities for the clarifica tions provided bilaterally.  The EC representative 
welcomed the information that the standards would be voluntary in nature, and there was no intention 
to make them mandatory.  China was encouraged to continue developing the standard in an open and 
transparent manner and to ensure effective partic ipation of all stakeholders concerned in its 
finalization, as well as in the development of the para llel generic standard on safety of batteries.   
163. The representative of China  noted that the draft standards on lithium mobile phone batteries 
were open for comments from all stakehol ders and were still under discussion.   
(xviii)  China – Domestic Gas Cooking Appliances (G/TBT/N/CHN/237) 
164. The representative of the European Communities  recalled concerns on the proposed national 
standard on gas cooking appliances.  The European Communities regretted that the new standard had 
been adopted despite the serious concerns expressed by the EC delegation.  However, it was noted 
that bilateral discussions on the issue were still on-going.  The European Communities encouraged 
China to give positive consideration to the EC propo sal, to set up an expert group and to suspend the 
application of the new requirements pending the outcome of the discussions. 
165. The representative of China  noted that his delegation had already provided replies to the 
European Communities in the previous TBT Commit tees; however, China welcomed the EC proposed 
bilateral meeting between experts.  It was also re called that the standard was based on a particular 
need of Chinese cuisine.   
(xix) India – Pneumatic Tyres and Tubes for Automotive Vehicles (G/TBT/N/IND/11 and 20) 
166. The representative of the United States  recalled his delegation's concerns with respect to the 
regulations on tyres and tubes.  He continued to seek a greater understanding of the objective and 
requirements of the Bureau of Indian Standards (B IS) protocol on conformity assessment procedures 
for tyres and to allay US industry’ s concerns that imported tyres may be treated less favourably than 
domestic tyres.  Additionally, the United States re presentative noted that a draft amendment to the 
Central Motor Vehicles Rules was proposed on 6 Ma y 2008, and stressed that one of its provisions 
appeared to govern conformity assessment for tyr es and seemed to require that tyres met the 
applicable requirements on 1 May 2008 – five days prior to the publication of the draft amendment.  
India was encouraged to provide clarification on how the draft amendment was related to the BIS 
Protocol, whether compliance was required on 1 Ma y 2008 and whether India intended to notify the G/TBT/M/45 
Page 30  
 
  draft amendment to the WTO.  The representative of  the United States looked forward to sharing the 
outcome of the current discussion with India with inte rested stakeholders in capital and to a continued 
dialogue with Indian authorities on this matter.  Fi nally, given India’s clarification that compliance 
with the BIS protocol would be mandatory once im plemented, coupled with the new draft amendment 
to the Central Motor Vehicles Rules, he urged India not to require compliance with the requirements  
until industry's concerns were addressed. 
167. The representative of Japan
 expressed concerns regarding the proposed classification system 
for the regulation of tyres.  In particular, th e Japanese delegation believed that the regulation had 
excessive participation costs and implementation peri ods were too short for foreign based firms.   
168. The representative of the European Communities  shared the same understanding as the 
United States and Japan with respect to the re gulations on tyres and tubes.  The European 
Communities believed this regula tion required burdensome requirem ents for tyre manufacturers 
without recognizing the equivalence of tyres complying with the UNECE regulation.  In fact, it was the EC delegation's view that these trade barrier s could be avoided by applying the globally 
harmonized specification.  The representative of the European Communities therefore expressed her 
delegation's encouragement for India's active participation in the 1998 UNECE Agreement 
discussions on a global technical regulation for tyres, and invited India to abstain from the adoption of 
the regulation which ran counter to international harm onization efforts.  She also asked India to give 
an update on the draft order and to explain if ty res complying with the UNECE regulation would be 
recognized.  Finally, India was encouraged to cl arify whether the notified draft had already been 
adopted and, in that case, when it would enter into force.   
169. With regard to the concerns raised by th e United States, the representative of India
 noted that 
his delegation had had a bilateral m eeting with the United States, where a number of issues had been 
clarified.  It was recalled that the United States raised concerns about the amendment in the motor 
vehicle rules and wanted to know whether this was related to the same measure.  The Indian 
delegation confirmed that the question was transmitt ed to experts in capital and a reply would be 
assured as soon as possible.  With regard to con cerns raised by the European Communities, it was 
recalled that comments would be sent back to capit al and responses would be given at the next TBT 
Committee meeting.  
(xx) China – Wines (G/TBT/N/CHN/197) 
170. The representative of the European Communities  reiterated concerns about a measure on 
wine, notified by China on 2 May 2006, which im posed, among other things, a level of sulphur 
dioxide which her delegation considered was unnecessar ily restrictive and which was below the levels 
established at the international level, as well as t hose accepted by the European Communities.  In fact, 
the proposed levels had caused problems to sweet wi nes which, until the date of entry into force of 
this measure, were permitted.  She noted that comme nts had been submitted and that a reply had been 
provided by China in which it was clarified that  China would not introduce the level of sulphur 
dioxide which had been indicated in the notification,  and that limits set in the Food Hygiene Standard 
would apply.   
171. However, it was highlighted that these limits were  even more restrictive than the previous 
ones, and were not in accordance with the inte rnational level.  It was the EC delegation's 
understanding that the Chinese standards were curren tly being reviewed and that the maximum level 
of sulphur dioxide would be increased and a ligned to those recommended by international 
organizations, which set a limit of 400mg/l.  The European Communities requested a formal 
confirmation of this information and urged China to promptly look into this matter and amend the 
currently applied levels to those established by th e Organization of Vine and Wine (OIV), as almost 
no wine could satisfy the low limits set by the Chinese authorities.  G/TBT/M/45 
 Page 31 
 
 
  172. The representative of China  pointed out that comments by the European Communities had 
been taken into account and a reply had already been provided.  It was stressed that this standard was 
being reviewed and that the relevant internati onal standards would be taken into account.  The 
reviewing process would probably be finalized by the end of 2008, and once finalized it would be 
notified bilaterally to the European Communities. 
(xxi) European Communities – Toys (G/TBT/N/EEC/184) 
173. The representative of Korea  raised concerns about the a bove-mentioned measure, notified by 
the European Communities on 27 February 2008.  Hi s delegation believed that the measure at issue 
was more trade restrictive than necessary to fulf il the legitimate objective and, in addition, was 
discriminatory to non-EC manufacturers because th e safety of imported toys was already assured 
through the process of EN 71 and CE mark.  The European Communities was invited to reconsider 
the measure and to guarantee that imported toys would not be discriminated against and treated 
unfairly.  
174. The representative of China  shared the concerns expressed by Korea and noted that his 
delegation had already sent its comments to the Eu ropean Communities in April, but no reply had 
been provided yet.  He encouraged the European Communities to provide a reply about this concern 
as soon as possible. 
175. The representative of the European Communities  pointed out that a written reply to the 
comments submitted by various delegations was being finalized and would probably be issued in two 
or three weeks. 
(xxii)  Canada – Compositional Requirements for Cheese (G/TBT/N/CAN/203) 
176. The representative of the European Communities  reiterated concerns about Canada's 
regulation governing compositional requirements for cheese.  Although certain rules had been revised 
in its final publication, the European Communities remained concerned about the negative impact of 
the new requirements.  The representative of th e European Communities emphasized that the new 
licensing requirements appeared to create unnecessary obstacles to trade and raised WTO incompatibility concerns; they appeared to be discr iminatory as they only applied to importers and not 
to domestic cheese producers.  In this context, th e beneficiary of the measure seemed to be the 
Canadian milk industry.  Finally, it was the EC  delegation's view that, without clear provisions 
regarding the enforcement of this measure, operators  would not be able to invest in the compliance 
mechanisms.  The representative of the European Communities urged Ca nada to take into account the 
comments expressed and postpone the entry into force of the new standards. 
177. The representative of the United States
 recalled that the new compositional requirements for 
cheese could impair access to the Canadian market, and could impose significant costs on US 
producers and processors, who would need to comply  with the related import licensing scheme.  He 
noted that the issue was being reviewed closely an d that the measure’s impact on US dairy exports 
would be monitored as well.  With respect to im plementation, the new requirements would become 
mandatory at the end of 2008 but Ca nada had still not set out the details of the licensing scheme.  This 
was a serious concern to industry, in particular given the apparent lack of a testing methodology that 
producers and processors could use to verify the mi lk protein content of cheese derived from raw milk 
as compared to other sources (e.g., milk protein concentrates).  Therefore, Canada was urged to set out the licensing system's draft provisions as soon as possible and to notify them to the WTO. 
178. The representative of Switzerland
 shared the concerns expressed.  In particular, her delegation 
was interested in receiving more information from Canada about the new licensing regime.  G/TBT/M/45 
Page 32  
 
  Switzerland noted that the new compositional require ments for cheese would enter into force in 2008 
and urged Canada to provide the requested information as soon as possible. 
179. The representative of Canada
 recalled the comments already made at the previous meeting of 
the Committee.  With respect to the comments about consistency with  WTO obligations, she stressed 
that these new harmonized cheese standards clarified the permitted ingredients for varietal cheeses 
and would provide consumers with greater produc t uniformity.  All cheeses bearing a particular 
varietal name would possess similar characteristics, irrespective of where they were purchased or by 
whom they were manufactured or distributed.  Th is reduced the risk of consumer confusion and 
prevented the use of deceptive practices.  Her delegation did not agree with those Members who 
asserted that the regulation was unnecessarily trade restrictive and would not be beneficial to 
Canadian consumers.  Many imported cheeses would al ready be consistent with  the regulations and it 
was expected that the amended regulations would not lead to reductions in the volume of imported 
cheeses.  Canada filled its annual cheese tariff rate quota, and imported specialty cheeses were in high 
demand among Canadian consumers. 
180. With respect to the licensing regime, Canada wa s still working to implement the new import 
licensing regime in a way that would minimize the impact on importers and foreign cheese suppliers.  
More information would be provi ded to trading partners on the import licensing regime as it was 
finalized.  With respect to discriminatory treatme nt, the food industry was responsible for having 
measures in place to verify that all products met the appropriate regulations , and the Canadian Food 
Inspection Agency (CFIA) would assess compliance.  The licensing regime would continue to require 
the use of an import declaration whereby the importer attests that the product meets all Canadian 
requirements.  The Canadian dele gation believed that the import licensing requirements would not be 
more onerous than the domestic requirements and therefore there would be no discriminatory 
treatment.  Other measures, such as buyer-seller agreem ents could be used by the importer in order to 
provide the necessary substantiation to the Canadi an food inspection agency.  In concluding, the 
representative of Canada stressed that the framewo rk for verifying compliance was expected to be 
provided in summer 2008. 
(xxiii)  Israel – Infant Formula 
181. The representative of the United States  recalled that his delegation had expressed concerns 
about the infant formula regime in Israel at th e last several meetings of the Committee.  His 
delegation's understanding was that Israel’s Ministry  of Health was working with stakeholders on a 
revised infant formula regulation that would set out  requirements for the sale of infant formula in 
Israel, and that the Israeli Knesset intended to fast-t rack its passage.  He sought further information on 
the status of those efforts and urged Israel to contin ue working with stakeholders to resolve this issue. 
182. The representative of Israel  confirmed that internal cons ultations were on-going between 
various Israeli authorities, regulators and stakeholders in order to address this issue and find an agreed 
solution to the concern of the United States.  She reca lled that in light of grave public health incidents 
following imports of infant food, the issue was se nsitive.  Israel remained available for further 
consultation on this issue with the United States on a bilateral basis. 
(xxiv)  China – Revision of the list of toxic chemicals s everely restricted in the People's Republic of 
China in the regulation for environmental management on the first import of chemicals and the import and export of toxic chemicals 
183. The representative of Japan
 recalled concerns about China’s Registration System for the 
import and export of toxic chemical.  He noted th at at the previous meeting of the TBT Committee 
China had stated that the regulation was being revi sed, and sought an update on the matter.  He further 
stressed that the regulation could conflict with Ar ticle 2.1 of the TBT Agreement, which states that  G/TBT/M/45 
 Page 33 
 
 
  “products imported from the territory of any Memb er shall be accorded treatment no less favourable 
than that accorded to like products of national orig in and to like products originating in any other 
country”.  In fact, the Chinese regulation required exclusively foreign-based  firms to pay US$10,000 
to import one item.  China was therefore requested to abolish the registration fee of the regulation. 
184. The representative of the European Communities  joined the representative of Japan in 
requesting an update on the review of the Chinese toxi c chemicals legislation.  In particular, China 
was invited to clarify when these consultations w ould be finalized and what the possibilities for 
foreign stakeholders to take part in the process were. 
185. The representative of China  confirmed that consultations were on-going and comments would 
be presented to the newly established Mi nistry of Environmental Protection. 
(xxv) Thailand – Labelling Requirement for Snack Foods (G/TBT/N/THA/215 and Add.1) 
186. The representative of the United States  recalled his delegation’s concerns with respect to 
Thailand’s labelling system for certain snack fo ods.  Although the United States appreciated 
Thailand’s efforts on its revisions to the measure  and supported Thailand’s  goal of promoting a 
healthier citizenry, industry groups from Thailand,  the United States and other trading partners, 
continued to raise questions as to whether the meas ure was necessary in light of alternatives.  His 
delegation had taken note of the r esponse provided by the Thai FDA in January 2008 to questions and 
concerns raised on the revised regulation, which i ndicated that nutritional labelling should be directed 
at all food categories and that mandatory labellin g requirements for snack foods and other foods 
"deemed necessary" would eventually be put in place "at appropriate stages".  The United States requested Thailand to issue a status report on when  it intended to implement such changes and what 
other food categories were being reviewed  for potential labelling requirements.   
187. Finally, the representative of the United States drew the Committee's attention to the ongoing 
work in Codex to review strategi es regarding diet and health, in pa rt stemming from concerns with the 
WHO’s Draft Action Plan for the Implementation of the Global Strategy on Diet, Physical Activity and Health.  He encouraged Tha iland to participate actively in the Codex work and to consider 
approaches that could have the benefit of both enc ouraging better health and facilitating trade.  His 
delegation looked forward to a continued dialogue  on this issue with the Thai authorities. 
188. The representative of Thailand
 noted that, as explained by the Thai Food and Drug 
Administration (FDA), the Ministerial Announcemen t No. 305 on snack food labelling served as one 
of many measures aimed at finding a solution to the problem of children’s malnutrition.  All sectors involved were in favour of devel oping supplementary measures, as illu strated by the efforts of the 
private sector in monitoring the advertisements for food and drinks consumed by children under 
twelve.  However, the Thai FDA had understood the US concerns and was ready to further discuss the 
issue. 
C. E
XCHANGE OF EXPERIENCES  
1. Good Regulatory Practice 
189. The Chairperson  recalled the WTO Workshop on Good Regulatory Practice held on 
18-19 March 200811 and drew delegations' attention to the su mmary report provided by the Secretariat 
(G/TBT/W/287).  She also recalled that at the last meeting the United States had introduced a paper 
                                                      
11 A Summary Report of the event is contained in document G/TBT/W/287.  More information, 
including the programme and presentations made, is also available on the WTO TBT Website at the following 
address:  http://www.wto.org/english/tratop_e/tbt_e/wkshop_march08_e/wkshop_march08_e.htm  G/TBT/M/45 
Page 34  
 
  on Determining the Need to Regulate (G/TBT /W/285).  She noted that the Committee's 
recommendations to date were mainly recommendations  to "exchange experiences"; this was reflected 
in the latest revision of the Committee's deci sions and recommendations in the area of Good 
Regulatory Practice, contained in Section I of G/TBT/1/Rev.9. 
190. The representative of the United States
 drew the Committee's attention to a joint paper 
prepared by the US Office of Management and Budget (OMB) and the Secretariat General of the 
European Commission, issued on May 2008 as part of the transatlantic High Level Regulatory Cooperation Forum.  The paper, entitled "Review of the Application of EU and US Regulatory Impact 
Assessment Guidelines on the Analysis of Impacts on International Trade and Investment", reviewed 
existing methodology and practices of both sides and suggested possible ways forward on the subject 
of considering international trade impacts in the regulatory process.   
191. The US section of the paper reviewed how the US regulatory framework enabled regulators to 
take into account the potential international trade an d investment impacts of draft regulations during 
the regulatory process.  It explained that US re gulatory agencies have bot h statutory and executive 
obligations to take international trade impacts into account when developing regulatory proposals.  In 
particular, OMB Circular A-4 provided that, for econom ically significant rules: "The role of Federal 
regulators in facilitating US participation in global  markets should also be considered.  Harmonization 
of US and international rules may require a strong Federal regulatory role.  Concerns that new US 
rules could act as non-tariff barriers to imported goods  should be evaluated carefully".  This guidance 
was in addition to US statutes, in particular the National Technology Transfer and Investment Act, 
which obliged agencies to use existing private sector standards, including private sector international 
standards, as the basis for regulations, or to  present a justification for not doing so.   
192. As a result of this study, the two sides recogni zed the importance of four key principles in 
ensuring that the impacts on trade and investment  were taken into account in regulatory impact 
assessments.  First, there was a need for timely  announcement of planned legislative or regulatory 
initiatives, and for transparency in the analysis pr esented by associated impact  assessments.  In this 
regard, OMB noted that it intended to ask all US  agencies for the fall 2008 Regulatory Agenda to 
adopt an approach similar to that of the US Depart ment of Transportation, which maintained an online 
database identifying regulations that could have impact s to trade or be of interest to major trading 
partners.  Second, it was important to ensure that  mechanisms such as public consultation and notice 
existed to give governments, businesses, and citi zens the opportunity to voice comments on planned 
initiatives and to reflect their input in impact asse ssment and impact analysis reports.  Third, the 
report emphasized the importance of making policy proposals and accompanying impact assessments 
(including relevant underlying technical analysis and data) public, thereby allowing governments and 
stakeholders in other countries to respond if they ex pected international trade and investment issues to 
be significant.  Fourth, it was important to provide  guidance to regulators to ensure they have the 
information they need to evaluate the impact of a regulation on trade and investment.  Such 
information could include an analysis demonstrati ng the need for any proposed regulation that could 
impede international trade; an analysis of the degr ee to which different groups were affected by such a 
proposal; or a recommendation that existing standard s or regulatory approaches, if applicable, should 
be analyzed as an explicit regulatory alternative. 
193. While OMB concluded that US federal agenci es were fulfilling their obligations, it agreed 
with commenters on the need to offer further guida nce on how to consider the international trade 
effects of US regulations.  Thus, OMB determined that it would provide further clarification of the 
current obligations and responsibilities to US regulators, in order to ensure that they continued to take 
international trade impacts into appropriate consider ation in preparing their impact analyses for draft 
regulations.  The representative of the United Stat es encouraged other delegations to share their 
regulators' experiences with analyzing the internati onal trade and investment impacts of regulations.   G/TBT/M/45 
 Page 35 
 
 
  He also invited the other delegations to comment on the joint paper or the broader issue of considering 
international impacts in the regulatory process. 
194. The representative of the European Communities  thanked the US delegation for introducing 
the above-mentioned joint paper.  He emphasized th at, in the light of that paper, the European 
Communities was considering amending its impact as sessment guidelines to take more account of the 
impact that proposed regulatory policies could have on  international trade and investment flows.  The 
European Communities would update the Committee on latest developments regarding the revision of 
the EC impact assessment guidelines. 
195. The representative of Mexico  informed Committee Members that his government was 
preparing a communication to share Mexico's experiences on Good Regulatory Practice.  He 
appreciated document G/TBT/W/285, which had been circulated among a number of Mexican 
authorities and helped to understand how to guarantee a correct drafting of regulations.  In his view, 
the TBT Committee's work on good regulatory practice had been extensive, thanks to the submission tabled in the Committee and the r ecently held Workshop.  He stres sed the need for further progress on 
specific recommendations, for instance: on regulatory impact assessment,  planning of 
standardization, proportionality and on the determinati on of the need to regulate.  Mexico proposed to 
prepare a document of voluntary recommendations in  order to provide further guidance for Members 
in implementing the TBT Agreement. 
2. Conformity Assessment Procedures 
196. The Chairperson
 recalled that since 1995 the Committ ee had issued a number of decisions 
and recommendations; there were set out in Sec tion II of G/TBT/1/Rev.9.  In terms of the 
Committee's work on conformity assessment, there had been extensive sharing of experiences, with a 
view to furthering the understanding and the implem entation of Articles 5-9 of the TBT Agreement.  
The Chairperson also noted that the Second Trienni al Review Report set out an "Indicative List of 
Approaches to Facilitate the Acceptance of  the Results of Conformity Assessment"12, and that four 
separate events dedicated to discussions on various aspects of conformity assessment had been held in 
1999, 2004, 2005 and 2006.  Members were encouraged  to come forward with contributions regarding 
their experiences on conformity assessment procedures. 
3. Transparency 
197. The Chairperson  emphasized the good progress made in the area of transparency, and this was 
reflected in document in Section IV of G/TBT/1/ Rev.9.  She recalled the Committee's Fifth Special 
Meeting on Procedures for Information Excha nge and noted that, at the meeting held on 
9 November 2007, Members had agreed on two mechan isms: one to facilitate access to notified draft 
texts and another to facilitate information-sharin g by Members on the availability of unofficial 
translations.13 
(i) Translations 
198. The representative of Kenya  drew the Committee's attention to the issue of translation of 
notifications issued by Members, in particular  with regard to the national enquiry points for 
developing and least developed countries.  She re quested the Committee to fu rther deliberate on this 
issue.  Kenya invited Members to consider provi ding translations on request under the special and 
differential treatment for developing countries. 
                                                      
12 G/TBT/1/Rev.9, Annex A. 
13 G/TBT/1/Rev.9, pp. 24-25. G/TBT/M/45 
Page 36  
 
  199. The representative of China
 welcomed the successful outcome of the Committee's Fifth 
Special Meeting on Procedures for Information Exch ange.  In this regards, China encouraged 
Members to attach a copy of the text of the notif ied measures to the notification forms, and further 
notify the adopted final text as an Addendum to th e original notification.  Additionally, China 
encouraged Members to share the translations of notified texts; this was especially important for 
developing countries to provide comments timely and effectively. 
(ii) Functioning of enquiry points 
200. The representative of Mexico  supported the comments made by China and recalled an issue 
often raised by the Mexican delegation.  He reque sted clarification on how the contact points of 
developed countries succeeded in providing individu als and companies with specific information on 
notifications circulated by the Secretariat of the WT O.  Mexico recalled that previous replies focused 
on how the contact points worked or what IT system  they had, but little had been explained as to how 
they managed to ensure an effective in teraction with industry and individuals.  
201. The Chairperson  recalled that the enquiry points were set up to answer enquiries and provide 
information.  Stakeholders, companies and individu als interested in their foreign trading partners 
technical regulations standards and conformity assessment procedures had to be encouraged to 
approach the enquiry points and ask for information. 
4. Technical Assistance 
202. The Chairperson  drew the Committee's attention to wo rk undertaken by Me mbers in the area 
of technical assistance and the decisions and recommendations taken so far (Section V of G/TBT/1/Rev.9).  She reiterated the importance attr ibuted by the Committee to technical assistance.  
It was noted that an exchange of experiences and identification of good practices in the delivery and 
receipt of technical assistance, in line with the mandate from the Fourth Triennial Review, could help advance Members' objective of increasing transparen cy in the need and availability of technical 
assistance.   
203. The representative of the United States
 recalled that, at the November 2007 Committee 
meeting, his delegation had enquired if other WTO Members would be interested in examining the 
work carried out by international standardizing bodies to broaden and deepen developing country 
participation in standards development activities at the technical level, as well as their efforts to 
strengthen developing country use of standards in specific sectors, both in the market place and in 
technical regulations.  A paper was subsequently pr epared by the US delegation and circulated prior 
to the March 2008 Committee meeting as JOB(08)/15.   
204. The representative of the United States said that his delegation recommended that the 
Committee examine the role of international standard s in economic development.   In this regard, the 
paper proposed to use case studies to examine the wa ys in which relevant in ternational standards had 
improved the quality of products, had solved specifi c regulatory problems or had facilitated trade in 
new markets.  The US representative further stressed that the paper offered a series of questions for 
Members to consider and discuss.  The goal was to dr aw out possible elements of interest so that a 
workshop might be organized that could reflect the broad cross-section of interests across WTO Members.   
205. It was stressed that at the last Committee meeting the United States had received support from 
various delegations on this proposal.  Discussions ha d been held with various  delegations, standards 
development organizations and inte rnational organizations on what the proposed programme for the 
workshop should be.  The United States proposed sev eral ideas for discussion at a workshop, for 
example on: (i) broad strategies and concepts; (ii) regional efforts to promote best practices in  G/TBT/M/45 
 Page 37 
 
 
  multilateral and bilateral assistance on standards; an d (iii) sector specific case studies with standards 
development organizations, regulat ors, national standards bodies (e.g., oil and gas, renewable 
energies, building codes and fire protection).  Th e representative of the United States invited 
Members to provide additional comments or ideas.  
206. The representative of Switzerland  supported the objective of the proposed workshop.  She 
stressed that international standards played an important role in economic development and were 
therefore of particular interest.  In her delegati on's view, the key outcome of the proposed workshop 
should be constituted by the recommendations and lessons learned with wide acceptance within 
Members of the Committee.  She noted that, besid es the decision on how the proposed agenda of the 
workshop could look like, this exchange of expe riences should be coordinated with relevant 
international organizations, such as World Bank,  UNIDO or UNCTAD, which already had experience 
on the role of international sta ndards in economic development. 
207. The representative of Brazil  supported the idea of a workshop on the role of international 
standards in economic development and offered sugges tions to be included in the workshop agenda.  
In particular, "new trends in standardization" could constitute a topic for discussion and include the 
participation of developing countries in the deve lopment of standards in areas such as biofuels, 
sustainability, nano-technologies and others.  It was also suggested that a second topic could deal with 
the critical issues in standardization and related activities, such as metrology tests or conformity 
assessment, and could lead to discussions about devel oping countries needs in terms of infrastructure, 
highly specialized personnel and technical coopera tion.  A discussion on the econometric models to 
assess the impact of international standards on econom ic development could be another topic to be 
included in the proposed agenda.   
208. The representative of China  welcomed the US proposal and recalled that the participation of 
developing country Members in international stan dards setting activities should be discussed in the 
Committee. 
209. The representative of the United States  noted that his delegation would continue seeking ideas 
from delegations, international orga nizations and standards developers  in order to further expand the 
proposal.  He hoped that the workshop could be held in 2009.   
5. Special and Differential Treatment 
210. The Chairperson  noted the Committee's work to date on Special and Differential Treatment 
set out under the relevant recommendations in Secti on VI of document G/TBT/1/Rev.9.  She recalled 
that the Fourth Triennial Review encouraged Me mbers to inform the Committee about special and 
differential treatment provided to developing country Members. 
IV. TECHNICAL COOPERATION ACTIVITIES 
211. The representative of Paraguay  stressed that his delegation attached great importance to 
technical assistance and thanked the European Co mmunities for the assistance provided in a project 
aimed at strengthening the competitiveness of Paraguay' s exports.  He noted that this project helped 
Paraguay to improve the quality system of technical regulations development a nd notification, and of 
standards and processes dealing with conformity asse ssment.  The project had also facilitated an 
increase of sanitary monitoring systems related to plant and animal health.  The representative of 
Paraguay also appreciated the cooperation of the Mexican government, which helped officials from 
Paraguay in understanding the notification system of the WTO.  Finally, he stressed the importance of 
setting standards in areas such as biofuels which in li ght of the critical situation of oil represented an 
interesting emerging market. G/TBT/M/45 
Page 38  
 
  212. The representative of UNECE
 informed the Committee about a recent interagency publication 
on the topic of Aid for Trade, which contained contributions from UNCTAD, UNDP, UNEP and the five Regional Commissions of the United Nations.  Th e joint project was officially presented in April 
2008 at the UNCTAD XII Conference.
14  The UNECE chapter reviewed  technical assistance activities 
related to standards and techni cal regulations on the basis of the OECD-WTO Trade Capacity 
Building Database and a number of official documents.  It was stressed that a number of shortcomings 
of ongoing assistance emerged from the research, in pa rticular as regards the insufficient ownership of 
the projects by national and regional stakeholders .  Many of the projects appeared to aim at 
facilitating the donor’s imports from the country that  benefited from the technical-assistance project 
without sufficient tailoring to the needs and priorities of recipients. 
213. The Aid for Trade initiative was aimed to bri ng increased and additional resources in the area 
of trade-related standards.  The objective was to  establish countries’ priorities in trade-related 
standardization matters in consultation with rele vant stakeholders; mainstreaming compliance with 
international standards in projects that focused on the development of productive capacities in specific 
sectors was also a priority.  In th is regards, the joint paper identified three broad areas of action: (i) 
reinforcing effective participation in standard s setting and the relevant WTO institutions; (ii) 
increasing compliance with technical regulations; (iii)  furthering the use of standards by business.  
Reinforcing participation by deve loping countries and transition economies was an essential step also 
for sustaining active involvement in the ongoing work  of the relevant institutions, including the TBT 
Committee and the regional and international standa rds development bodies.  In devising programmes 
directed at increasing compliance, the aim was to pr event rather than respond to critical situations.  
Particular attention was given to involve the busin ess sector, trying to better understand its priorities 
and needs.  Finally, it was stressed that standard s were not only a means of securing market access: 
they had an extra value because they were develope d by international experts and embodied the latest 
technology, also raising output quality and providi ng firms with know-how which enabled them to 
lower costs.  They also acted as a selection device, assisting those producers who were able to adapt 
to them.  
214. The representative of UNECE emphasized that the real value of Aid for Trade in the area of 
trade related standards was to empower recipient co untries to make an informed choice regarding the 
instrument that best met their development needs a nd the priorities of national stakeholders.  In this 
context, the assistance given through “South-South”  cooperation projects was of great value and had 
to be appropriately recognized, incl uding through the development of a repository of best practice that 
would represent a useful complement to the OECD /WTO database.  The UNECE representative also 
reported on the establishment of the Interagency Cluster on Trade and Productive Capacity, which 
included UNCTAD, UNIDO, FAO, ITC, UNDP, WTO and all the UN Regional Commissions.  The cluster aimed at assisting countries in the preparation of the UN country plans or United Nations Development Assistance Frameworks (UNDAF s) by strengthening cooperation among the UN 
agencies at the national level, and also aimed at in creasing the assistance that the UN gave for trade-
related development goals in the area of standards. 
215. The Secretariat
 informed the Committee that a two weeks specialized course on the TBT 
Agreement would be held on 27 October - 7 November 2008.15  The aim of the course was to promote 
greater understanding of the TBT Agreement and to address implementation challenges in a practical 
manner, through a series of sessions and practical exerci ses.  It was noted that the first week of the 
course would include general sessions to increase understanding of the TBT Agreement and focused 
sessions on topics such as transparency, good regulatory practice and conformity assessment.  The second week would focus on the operation of the TBT Co mmittee, in particular, participants would be 
                                                     
 
14 The publication is available for downlo ad from the UNCTAD XII Conference website: 
http://www.unctadxii.org  
15 See document WT/COMTD/W/160, page 54.  G/TBT/M/45 
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  invited to attend the TBT Committee Meeting on 5-6 N ovember in order to observe the work of the 
Committee.  The Secretariat noted that the course was organized for 25 participants from developing 
country Members or Observers.  Selected participants  would be expected to be familiar with the TBT 
Agreement and knowledgeable of national issues relating to its implementation. 
V. UPDATING BY OBSERVERS 
216. The representative of IEC  updated the Committee on the relevant activities undertaken by her 
organization (G/TBT/GEN/72). 
217. The representative of OIML  updated the Committee on the work of his organization.  With 
regard to mutual acceptance arrangement, it was noted that OIML had three categories of measuring instruments, with twenty countries participating in two of them.  Moreover, OIML was developing 
guides on the application of conformity assessment to legal metrology, as well as a conformity to type 
system which endeavoured to ensure that the pr oduction of measuring instruments matched the type 
approved.  An international system was also being prepared for the control of pre-packaged goods.  
With regard to accreditation, two guides had been developed jointly with ILAC and IAF: one on the 
application of ISO/IEC guide 65 for legal metrolog y and the other one on the application of ISO/IEC 
17025.  It was recalled that OIML participated in  the work undertaken by the Joint Committee for the 
coordination of technical assistance to Developi ng Countries in Metrology, Accreditation and 
Standardization (JCDCMAS).  It was noted that  the OIML budget would be decided in October 2008 
and that the developing countries fee would be a te nth of that which was currently set as a minimum 
fee for a Member state. 
218. The representative of ITC
 updated the Committee on two TBT related projects currently 
being implemented in Bangladesh.  The first project, named "Bangladesh Quality Support 
Programme", was funded by the European Co mmission and consiste d of two components 
implemented both by UNIDO and ITC.  The “s upporting export diversification” component was 
implemented by ITC and its main purpose was to e nhance the awareness and capacity of the private 
sector to cope with international quality standards, TBT or SPS re quirements.  The ITC representative 
noted that one of the main results envisaged was to enhance ability of the business sector to take 
advantage of the TBT and SPS Agreements for ma intaining and improving market access.  In 
February 2008, a workshop named "The WTO Agreem ent on TBT: a Business Perspective" was also 
held in Dhaka.  The workshop helped potential trainers and other partic ipants to understand the 
information on the TBT Agreement covering standa rds, technical regulations and conformity 
assessment procedures, and helped to understand how business could take advantage of the TBT 
Agreement.  In November 2008, two other works hops directed towards export-oriented industry 
would be organized.  The representative of ITC noted that an assessment had been made on the 
current capacity of the organizations in the priv ate sector and TBT Enquiry Points to obtain and 
disseminate information.  Recommendations were also  made to enable private sector organizations to 
work in partnership with the TBT Enquiry Po ints and enhance their capability to access and 
disseminate such information.  It was stressed that  further assistance would be provided to implement 
these recommendations.  In particular, a study tour to TBT National Enquiry Points in the region would be conducted for participants from the TBT National Enquiry Point and private sector bodies in 
Bangladesh later in 2008.  
219. The second project, which was financed by the Go vernment of Italy, was named "Bangladesh 
Leather Service Centre for Export Development".  Its pivotal element was the creation of a “Leather 
Service Centre” for the Bangladeshi industry, focusing in particular on added-value products such as 
footwear and leather goods.  The object was to provide assistance to the laboratories of the Bangladesh College of Leather Technology used by  the "Bangladesh Leather Service Centre", in 
order to help them to be accredited by the International Laboratory Accreditation Cooperation G/TBT/M/45 
Page 40  
 
  (ILAC).  The applications for accreditation would have  to be submitted by the end of June, with the 
aim of enabling the laboratories to obtai n accreditation before the end of 2008. 
220. The representative of ISO
 updated the Committee on the relevant activities undertaken by his 
organization, drawing the Members' attention to the ISO 2007 Annual Report and to the special issue 
of its magazine "ISO Focus" dedicated to conformity assessment.16  With regard to technical 
assistance and participation of developing countries in the development and implementation of ISO 
standards, it was noted that the Committee had been  regularly informed of ISO's programmes in this 
area, and of its collaboration with WTO, other inte rnational organizations and development agencies.  
The representative also recalled that the ISO Acti on Plan for developing countries currently being 
deployed covered awareness raising, capacity bui lding, use of IT tools, regional cooperation and 
participation in ISO's governance and technical wo rk.  Finally, ISO welcomed the proposal of 
organizing a workshop on the role of international standards in economic development and was ready 
to share its relevant expe rience with the Committee. 
221. The representative of UNECE  updated the Committee on the relevant activities undertaken by 
the UNECE Working Party on Regulatory Cooperation and Standardization Policies.  The UNECE 
representative explained that the Working Party co ntinued to reinforce c ooperation among regulatory 
authorities in a number of areas, including mark et surveillance and sectoral initiatives aimed at 
reducing the barriers to trade in products where authorities and business sectors had manifested interest.  The next annual session would take pl ace in November 2008 and would include a session on 
the role of private standards, or company specifications in a complex environment which also 
included international standards and technical regula tions.  She welcomed Members' participation in 
such session.  The UNECE representative expressed her organization's willingness to contribute to the 
proposed workshop on the role of international standards. 
222. The Chairperson
 drew the Committee's attention to  a statement submitted by the Codex 
Alimentarius Commission, contained in document G/TBT/GEN/71. 
VI. OTHER BUSINESS 
(i) Preparation of the Fifth Triennial Review of the TBT Agreement 
223. The Secretariat  introduced draft document JOB(08)/52 containing the ninth revision of the 
compilation of the TBT Committee's Decisions and Recommendations adopted since 1 January 1995.  
Members were invited to provide comments on th is document by 31 July 2008.  Thereafter the 
document would be circulated as G/TBT/1/Rev.9.17  
224. The Chairperson  recalled that the Committee would undertake its Fifth Triennial Review of 
the Operation and Implementation of the TBT Agre ement under Article 15.4 at the end of 2009.  In 
order to facilitate the preparation of the Review sh e intended to provide delegations with an outline of 
the process ahead of the next meeting.  She also st ressed that the Review needed to be driven by 
substantive proposals from Members and delegations were invited to submit such proposals as early 
as possible.  In terms of the substantive input, th e Chairperson proposed that when considering the 
various topics discussed in the context of the Fifth Triennial Review, Members give particular thought 
to what actions the Committee might take to forw ard its work.  When considering what areas were 
worth building on, or further refining, the Secretar iat's document G/TBT/1/Rev.9 could usefully serve 
as a reference point in this exercise. 
                                                      
16 Both documents were made available at the Committee meeting. 
17 G/TBT/1/Rev.9 was circulated on 8 September 2008.  G/TBT/M/45 
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  VII. DATE OF NEXT MEETING 
225. The next regular meeting of the TBT Comm ittee will take place on 5-6 November 2008.   
 
  
 
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