RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/49 
22 December 2009 
 (09-6688) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 5-6 NOVEMBER 2009 
 
Chairperson:  Mr. Ami Levin (Israel)
 
 
Note by the Secretariat1 
 
   
I.
 ADOPTION OF THE AGENDA.............................................................................................2  
II. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2................................................................2  
B. SPECIFIC TRADE CONCERNS .......................................................................................................2  
1. New Concerns................................................................................................................... .........2  
2. Previously raised concerns..................................................................................................... 11 
III. ANNUAL TRANSITIONAL REVIEW (TRM) MANDATED IN PARAGRAPH 
18 OF THE PROTOCOL OF ACCESSION OF THE PEOPLE'S REPUBLIC 
OF CHINA....................................................................................................................... ........55  
IV. TECHNICAL COOPERATION ACTIVITIES...................................................................62  
V. UPDATING BY OBSERVERS .............................................................................................62  
VI. FIFTH TRIENNIAL REVIEW .............................................................................................63  
VII. DATE OF THE NEXT MEETING .......................................................................................63  
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. G/TBT/M/49  
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  I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3457. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2   
2. The Chairman  recalled that the latest list of stat ements submitted under Article 15.2 of the 
TBT Agreement was contained in G/TBT/GEN/1/Rev.8,  issued on 2 March 2009.  Since the previous 
meeting of the Committee, Colombia and Egypt had submitted revisions to their statement under 
Article 15.2 (G/TBT/2/Add.18/Rev.3 and G/TBT/2/Add. 34/Rev.1 respectively).  In total, since 1995, 
118 Members had submitted at least one Statem ent on implementation under Article 15.2.  
Additionally, the latest list of enquiry point contacts was contained in document 
G/TBT/ENQ/35/Rev.2, issued on 13 May 2009. 
3. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) Saudi Arabia, Bahrain and Kuwait – Hala l Food Requirements (G/TBT/N/KWT/20; 
G/TBT/N/BHR/131; G/TBT/N/SAU/69) 
4. The representative of Australia  raised concerns about certain proposed requirements for 
accreditation of Halal food certification bodies, notifie d by Kuwait, Bahrain and Saudi Arabia.  While 
Australia appreciated the commitment by countries of the Gulf Cooperation Council (GCC) to adopt 
standards of the Gulf Standard Organization (GSO),  GCC members were encouraged to nominate one 
Member acting as a single TBT notification authority on behalf of the GSO or the GCC Secretariat.  
This could simplify the process of delivering notif ications and responding to comments provided by 
other WTO Members.  With regard to the abov e-mentioned notifications, the representative of 
Australia informed the Committee that written comments had been sent to the enquiry points of all the 
Members concerned but no reply had been received to date.  She looked forward to a satisfactory 
response to her delegation's concerns with a vi ew to working cooperatively with GSO countries. 
5. The representative of Saudi Arabia  said that the comments by Au stralia would be conveyed to 
capital for due consideration. 
(ii) United States – Ban on Clove Cigarettes (G/TBT/W/323)  
6. The representative of Indonesia  raised his delegation's concern as outlined in document 
G/TBT/W/323 with respect to the US "Family Smok ing Prevention and Tobacco Control Act", which 
had entered into force on 22 June 2009.  He partic ularly regretted that the new measure prohibited the 
production and marketing of cigarettes containing cer tain additives, including clove, but permitted the 
production and sale of other flavoured cigarettes, such as cigarettes containing menthol.  Indonesia 
believed that the US measure discriminated against imported clove cigarettes and created an unnecessary barrier to trade under the TBT Agreement.   Therefore, the representative of Indonesia 
urged the United States to revoke the measure. 
7. The representative of the United States
 indicated that the United States was not going to 
reverse the ban on clove cigarettes given the high priority the Obama Administration placed on protecting the health of Americans, especially youth.  US health authorities support a ban on clove  G/TBT/M/49  
 Page 3 
 
 
  cigarettes to protect the public health.  He noted th at clove cigarettes were particularly appealing to 
youth and represented a "starter product" that could lead to the use of regular cigarettes.  In particular, 
he stressed that clove cigarettes made it easier for new smokers to start smoking by masking the harshness of cigarette smoke and, like other ba nned fruit flavours, could ease the transition to 
addiction.  Evidence also indicated that clove ciga rettes could pose a range of additional health risks 
over conventional cigarettes.  With regard to the allegation of discrimination, the US representative 
noted that substantial differences related to c onsumption, use patterns, and epidemiology existed 
between clove and menthol cigarettes, which made th e two situations not comparable.  He noted that 
the US Food and Drug Administration (FDA) had est ablished a Scientific A dvisory Committee that 
would support additional studies of menthol cigarett es before deciding an appropriate public health 
action.  His delegation was open to further discussi ng the issue with Indonesia, so that Indonesian 
regulators could better understand the scientific basis for the US action. 
(iii) Canada – Bill C-32 amendment to Tobacco Act   
8. The representative of Argentina
 raised a concern regarding Canada's legislation "Cracking 
Down on Tobacco Marketing Aimed at Youth Act", which had entered into force on 8 October 2009.  
He stressed that his delegation supported Canada's  objective to prohibit the production and marketing 
of tobacco products which could attract youth.  Ho wever, he emphasized that this measure was more 
trade-restrictive than necessary to achieve Canada's  legitimate objective.  The representative of 
Argentina noted that the measure prohibited the u se of various additives in certain tobacco products, 
including cigarettes, cigarillos and blunt wraps.  In this regard, he stressed that cigarettes made of 
several types of tobacco, such as blended cigarette s, contained several additives prohibited by the 
Canadian regulation.  These additives, however, were not used to give a characterizing flavour to the 
product, rather they were used as an essential co mponent to mitigate the strong flavour of Burley 
tobacco.  A prohibition of these additives could therefore represent a de facto  prohibition of blended 
cigarettes.  The representative of  Argentina further noted that a ban on the production and sale of 
products with a certain flavour would represent a l ess trade-restrictive mean  to achieve Canada's 
objective, and thus be in line with  Article 2.2 of the TBT Agreement.  He also said that Canada based 
its legislation on the ingredients contained in a product without considering the effects of such 
ingredients on the final product, contrary to the obl igations under Article 2.8 of the TBT Agreement.  
The Argentinean delegate noted that Canada had not notified the measure to the WTO.  In this regard, 
he informed the Committee that prior to the adoptio n of the measure, the Argentinean Federation of 
Tobacco Producers and the Government of the Pr ovince of Salta had sent written comments to the 
Canadian Ambassador in Buenos Aires expressing their concern.  However, these comments had not 
been taken into account.  Finally, Canada was i nvited to amend this measure according to its 
obligations under the TBT Agreement. 
9. The representative of Mexico  supported the comments made by Argentina with regard to the 
Canadian legislation and regretted that Canada had neither notified the measure to the WTO nor taken 
into account other Members' views.  In this rega rd, Mexico expressed a systemic concern regarding 
legislative branches in a number of countries, including Canada, not seeming to see themselves bound 
by the transparency obligations of the TBT Agreement. 
10. The representative of Switzerland  shared the concerns expressed by previous speakers.  While 
Switzerland supported the objective of protecting human health, concerns remained that the 
legislation had not been notified to the WTO. 
11. The representative of Colombia  echoed the concerns expressed by Argentina, Mexico and 
Switzerland regarding the new Canadian legislation on tobacco.  She believed that the legislation was 
not consistent with Article 2.2 of the TBT Agreement which stipulated that "technical regulations 
shall not be more trade-restrictive than neces sary to fulfil a legitimate objective".  While the 
legislation had the de facto  effect of banning blended tobacco, there was no scientific evidence G/TBT/M/49  
Page 4  
 
  proving that blended cigarettes were more attrac tive to youth than traditional cigarettes, which 
represented ninety-eight per cent of the Canadian tobacco market.  Therefore, Colombia invited 
Canada to consider less trade-restrictive altern atives to achieve its objective and ensure that its 
measure was consistent with the obligations under the TBT Agreement.  The delegation of Colombia 
further emphasized that, absent such changes, expor ts of tobacco products  to Canada would be 
seriously disrupted and the devel opment of expansion plans for the growing of Burley tobacco would 
be negatively affected. 
12. The representative of the European Communities
2 joined other delegations in expressing 
concern regarding Canada's measure on tobacco.  In  particular, the EC representative reiterated the 
importance of Members fully complying with their transparency obligations under the TBT 
Agreement, in particular those related to the no tification of technical regulations and conformity 
assessment procedures.  She also noted that this issu e had been raised in an EC submission to the Fifth 
Triennial Review of the Operation a nd Implementation of the TBT Agreement.3  The EC 
representative regretted that the Canadian measure  had not been notified to the WTO and recalled 
that, according to Article 2.9 of the TBT Agreement, Members needed to ensure that draft legislation 
that could have a significant impact on trade be no tified to the TBT Committee at an early appropriate 
stage when comments could still be taken into accoun t.  Therefore, the European Communities urged 
Canada to postpone the implementation of the legi slation and notify the Commi ttee at an early stage 
any measure which laid out its  implementing provisions.   
13. The representative of Turkey  echoed concerns expressed by others.  He emphasized the 
importance of tobacco exports for the Turkish ec onomy and noted that the measure was currently 
under consideration by Turkish authorities.  Comme nts on the legislation would be provided in due 
time. 
14. The representative of the United States  strongly supported Canada's  objective of deterring 
youth from tobacco use.  However, he asked the Ca nadian delegation to provi de further information 
on the approach taken and on any measures necessa ry to implement the new regulation.  Could 
Canada confirm when Sections 4 and 5 of the Toba cco Act would enter into force?  Could Canada 
confirm that its Government had the authority to amend the schedule of additives regulated?  Was the 
Government of Canada consideri ng any amendments to the schedule of additives?  Could Canada 
provide further information on the criteria used to develop the list of prohibited additives?  Finally, 
could Canada explain what specific efforts had be en made to identify the relationship in general 
between prohibited additives and products marketed to  or that are innately attractive to youth?  The 
United States looked forward to receiving Canada ’s responses and improving the US understanding of 
the measure and its relationship to the TBT Agreement.   
15. The representative of the Former Y ugoslav Republic of Macedonia (FYROM)  supported the 
comments made by previous delegations with regard  to the Canadian legislation and highlighted the 
importance of the tobacco sector for his delegati on's economy.  While the Former Yugoslav Republic 
of Macedonia supported the objective of protecting human health, concerns remained that the 
regulation could constitute an unnecessary barrier to trade. 
16. The representative of Canada  explained that the "Cracking Down on Tobacco Marketing 
Aimed at Youth Act" was designed to address public  health concerns by reducing the incentives for 
                                                      
2 On 1 December 2009, the Treaty of Lisbon amendi ng the Treaty on Europe an Union and the Treaty 
establishing the European Commun ity (done at Lisbon, 13  December 2007) entered into force. On 
29 November 2009, the WTO received a Verbal Note (WT /L/779) from the Council of  the European Union and 
the Commission of the European Communities stating that, by virtue of the Treaty of Lisbon, as of 1 December 2009, the European Union replaces and succeeds the European Community. 
3 G/TBT/W/309.  G/TBT/M/49  
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  young people to smoke.  She clarified that the new legislation prohibited, inter alia , the use of various 
flavours and other additives in certain tobacco pr oducts, including cigarettes, cigarillos and blunt 
wraps sold in Canada.  She stressed that the legi slation did not ban any type  of tobacco or tobacco 
product.  In this regard, it was Ca nada's understanding that since n on-blended Burley cigarettes were 
currently sold on the Canadian market it was not correct to state that the ban on additives constituted 
an implicit ban on Burley tobacco.  The Canadian de legate assured delegations that Canada's trade 
obligations had been taken into account in drafting the legislation and that Canada was committed to 
respecting its international trade obligations wh ile meeting its legitimate public policy objectives. 
17. With respect to the allegation on the lack of sc ientific evidence, Canada believed that the 
dangers of tobacco use were well documented in scien tific and public health literature; indeed there 
was sound scientific evidence to demonstrate that certain additives, including flavours, increased the 
attractiveness of tobacco product.  In this regard, the Canadian representative explained that some 
documents produced by the tobacco industries and subsequently made public by courts through 
litigation, had shown that the use of the additiv es banned by Canada made tobacco products more 
appealing to youth.  She further noted that sever al other countries had introduced legislation that 
aimed at protecting youth from tobacco marketing.  However, while the approach of such countries 
was only limited to banning specific flavours, the appr oach of the Canadian Government targeted a 
broader range of additives that were used to make  cigarettes and other products more appealing to 
youth and novice smokers.  In particular, the Cana dian legislation introduced a list of prohibited 
additives that included additives with flavouring properties but also other additives such as 
sweeteners, vitamins, minerals and colouring agents .  It was Canada's view that this legislation 
provided for more precision and cer tainty and that there was sound scientific evidence for prohibiting 
the use of such additives. 
18. With regard to more systemic concerns about the non-notification of mandatory measures, the 
Canadian representative said that comments would be  conveyed to capital for due consideration.  She 
also reassured Members that any implementing measur e of the tobacco legislation would be notified 
to the WTO at an early stage.   
(iv) Chinese Taipei – Organic Products (G/TBT/N/TPKM/65 and 69)  
19. The representative of the European Communities  expressed concerns about measures relating 
to the import of organic products in Chinese Taipei, notified in G/TBT/N/TPKM/65 and 69.  She informed the Committee that comments on this measure  had been sent to Chinese Taipei in February, 
May and October 2009.  While the European Comm unities welcomed the clarifications received, 
important concerns remained.  The EC represen tative particularly regretted that, despite the 
information provided by her delegation, the meas ures at issue were applied by Chinese Taipei 
differently between the twelve newer and fifteen ol der EC member States.  She stressed that this 
distinction was unjustified and discriminatory. The EC representative recalled that the same organic 
legislation was uniformly applied across all the EC member States and that this legislation had been 
recognized by the Chinese Taipei authorities to be equivalent to that applied in Chinese Taipei. She 
noted that organic production, labelling and control was regulated at the European Communities level 
and was implemented identically throughout all EC  member States. Furthermore, in the case of 
recently acceded EC member States, the organic le gislation was implemented without any transition 
period from the date of their accession to the Eu ropean Communities.  The European Communities 
believed that sufficient information had been provide d to Chinese Taipei authorities to carry out an 
equivalence assessment between the respective legisl ations on organic products.  Chinese Taipei was 
therefore invited to extend its approval procedur e to the twelve new EC Member States without 
further delay. 
20. The representative of Switzerland
 noted her delegation's concern with Chinese Taipei's 
legislation on organic products.  She stressed th at the administrative procedures established for G/TBT/M/49  
Page 6  
 
  achieving equivalence status for plant organic pro ducts were burdensome and non-transparent, could 
cause heavy delays, block merchandise and provoke financial losses for exporters concerned.  
Switzerland therefore invited Chinese Taipei to assure prompt and pragmatic administrative procedures for the remaining steps to  be undertaken to achieve equiva lence status for animal organic 
products. 
21. The representative of Chinese Taipei
 explained that its review of  organic equivalency covered 
not only regulations and technical specifications  concerning organic agricultural products and 
processed products adopted in foreign countries, but also the development of the organic agriculture 
sector, as well as the implementation and enforcement of organic management systems.  She stressed that Chinese Taipei had recognized the EC regula tions and technical specifications concerning 
organic agricultural products and processed products  as being equivalent.  However, concerns 
remained about the lack of information with rega rd to the development of the organic agriculture 
sector and with regard to the effective implementation of the EC organic management system in the twelve newer EC member States.  The recognition of equivalence for the twelve newer EC member 
States was still pending until such information was pr ovided.  In this regard, the representative of 
Chinese Taipei invited these Members of the WTO to provide further information about:  (i) the 
organization structure, workforce and division of labour of the competent authority, and evidence of implementation of the relevant EC regulations;  (ii) the ratio of agricultural area certified as organic to 
the total agricultural area of the country, and the total numbers of certified organic farms, processing 
operators and main product items;  (iii) the results  of tests or inspections of organic products 
performed by certification bodies including the num ber of cases, the compliance rates, and the 
disposition of non-compliant products for the last three years;  (iv) the substantive content of plans for 
monitoring of organic products by the competent au thority and reports of the last three years, 
including the number of cases, the compliance rate s and the disposition of non-compliant products.  
22. Finally, the representative of Chinese Taipei in formed the Committee that a meeting between 
Chinese Taipei's Council of Agriculture and the Eu ropean Economic and Trade Office had been held 
on 29 October 2009.  She noted that the European Ec onomic and Trade Office had agreed to provide 
the required information as soon as possible for Ch inese Taipei's review.  Chinese Taipei looked 
forward to working constructively with the Eur opean Communities until the concerns were fully 
resolved. 
(v) Canada – Milk Class 4m   
23. The representative of New Zealand
 raised concerns regarding a current proposal before the 
Canadian Milk Supply Management Committee to ma ke available domestic milk proteins for cheese-
processing at reduced prices compared to imported milk proteins under milk class 4m.  New Zealand 
was concerned that such a proposal could create a tw o-tier pricing system for milk proteins in cheese 
manufacture, with domestic prices undercutting imports, currently priced in more expensive milk classes 3(a) and 3(b).  The representative from New Zealand stressed the fact that it had been difficult 
to obtain further details on the proposal and hen ce to determine the exact nature of the programme, 
including any implications under the TBT Agreement.   New Zealand was therefore also considering 
raising this issue at the next WTO Agriculture Committee Meeting.  New Zealand requested Canada 
to provide specific details of the proposal. 
24. The representative of the European Communities
 echoed the concerns and remarks made by 
New Zealand and noted that the proposed measures were currently under consideration and that 
further information in this regard would be useful. 
25. The representative of Australia  shared the concerns raised by New Zealand and echoed by the 
European Communities.  Australia would welcome more specific details from Canada on the proposal  G/TBT/M/49  
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  and in particular clarification by Canada whether the dual pricing system was consistent with Article 
2.1 of the TBT Agreement. 
26. The representative of Canada  took note of the comments made by New Zealand, the European 
Communities and Australia. She informed the con cerned delegations that there was no specific 
proposal on the table at the moment, but only related discussions taking place.  Furthermore, she 
noted that Canada failed to see the relevance of  the WTO TBT Agreement in connection to the 
concerns raised.  
(vi) Canada – Ontario Ice Cream Subsidy   
27. The representative of New Zealand  expressed concerns about the Canadian dairy industry’s 
ice-cream subsidy programme, and the extent to which it might be an ‘import replacement’ 
programme supported by the Canadian Government.  She explained that it had been difficult to obtain 
details on the programme and thus  to determine the exact nature of the programme, including any 
TBT implications. She announced that New Zealand wa s considering raising this issue at the next 
WTO Agriculture Committee Meeting.  New Zeal and requested Canada to provide the TBT 
Committee with specific details on the programme including on the role of the relevant federal 
agency, the Canadian Dairy Commission, in facilitating the programme. 
28. The representative of the European Communities  supported the comments made by New 
Zealand and announced that the EC delegation was studying this measure in order to determine 
whether it contained any elements related to the WT O TBT Agreement.  She also requested Canada to 
provide further information on the programme.  
29. The representative of Canada  took note of the concerns expressed by New Zealand and the 
European Communities regarding th is initiative.  She explained that Canada failed to see the 
relevance to the WTO TBT Agreem ent, because the initiative was neith er a Government of Canada 
nor a Canadian Dairy Commission program.  She explained that the Canadian Dairy Commission 
merely calculated the pooling returns on behalf  of producers, but that producers decided for 
themselves the manner in which they disposed of their revenues. 
(vii) Israel – Regulation 31/08, the “Regulation fo r Labeling of Imported and Locally Produced 
Automotive Products – Name of Manufactu rer and Country of Origin Requirements”  
30. The representative of the United States  expressed serious concerns regarding Israel's country 
of origin labelling requirement for automo tive products under Regulation 31-08. The US 
representative explained that the United States did not  object to Israel’s requirement that automotive 
products be labelled with the count ry of origin, a requirement that had existed for some time.  
However, under this new regulation, US automotive pr oducts would be treated differently than Israeli 
products and products of other trad ing partners by requiring the label to include, in addition to the 
country of origin, the US state and possibly the city of manufacture. These requirements had generated significant concern among US auto parts ma nufacturers.  He recalled that Israel had not 
provided a plausible justification for the difference in  such treatment and that the US was also unable 
to find such justification.  Furthermore, he noted  that the United States had procedural concerns, as 
Israel had not notified this regulation to the WTO for comment which hampered the efforts of other 
members to provide meaningful comment on the measur e.  Given that the regulation appeared to treat 
US automotive products differently to those from ot her countries and raised procedural concerns, the 
US representative requested that Israel's Ministry  of Transportation repeal the additional marking 
requirements for US products 
31. The representative of Israel
 announced that after a bilateral meeting between the United States 
and Israel the matter had already been brought to th e attention of the Ministry of Transportation, the G/TBT/M/49  
Page 8  
 
  government body currently analyzing the issue.  He recalled that when implementing Regulation  
31-08 the relevant authorities applied a liberal approach requiring in many cases only to mention 
simply the country of origin of the goods.  Rega rding the specific US trade concern, the representative 
of Israel said that the issue was being discussed by the relevant Israeli authorities and that his 
delegation would soon be in the  position to inform the United States of the decision adopted.  
(viii) Indonesia – Decree No. Kep-99/MUI/III/2009 relating to Halal certification  
32. The representative of the United States
 raised a concern regarding Halal certification in 
Indonesia.  He began by noting that the United Stat es respected Indonesia’s right to regulate trade in 
Halal products.  However, Indonesia’s regulations shoul d be developed in a manner that is transparent 
and does not disrupt trade.  In the US view, the development of Indonesia's Halal certification system 
was not transparent and, as a result, many traders and certifiers had been caught by surprise.  Some, 
including poultry traders that have provided Halal products to Indonesia's market for many years, had 
found themselves shut out of the Indonesian market .  He further noted that the rules which accredit 
Halal certifiers were unclear and would act to rest rict or eliminate exports of certain foods to 
Indonesia.  As a first step in addressing the current situation, the US representative urged Indonesia to 
allow previously recognized Halal certifiers to c ontinue to certify Halal products while Indonesia 
addressed the concerns of trading partners in re vising the measures.  The US representative also 
stressed the importance of continuing to accept and revi ew applications from certifiers that had not yet 
been approved.  
33. Regarding the final certifiers list released on 22 October 2009, it was noted that the previous 
list of Halal certifiers had apparently been can celled on 1 October 2009, but the Government of 
Indonesia had not posted the new certifiers list on the MUI website until 22 October.  This delay 
affectively had eliminated imports of legitimate Hala l goods for three weeks.  In addition, the process 
to apply for and gain MUI approval had not been set out in the 9 March decree and had not been 
publicly announced.  As a result, many certifiers di d not know that they were required to reapply and 
were not aware of the current rul es for Halal accreditation.  The US  representative asked Indonesia to 
explain the criteria used to recognise Halal certifie rs and whether Indonesia would make these criteria 
available and allow stakeholders to provide comment s.  The new list of Halal certifiers also did not 
include any certifiers for poultry or lamb; until 1 October 2009 there had been eight US poultry 
certifiers accredited by MUI and now these certifi ers were apparently no longer recognised by 
Indonesia.  Could Indonesia explain why it no longe r recognized these certifiers?  This omission of 
any poultry certifiers from the recognized list functio ned to block US exports of poultry to Indonesia.  
Moreover, an attachment to the certifiers list indicat ed that the certifiers set out therein could only 
certify raw materials.  This suggested that these cer tifiers could not certify the Halal finished or retail 
level goods, including processed foods. The represent ative of the United States therefore asked for 
clarification from Indonesia whether this was indeed  the case and if so, to explain the rationale and 
explain how finished or retail leve l goods could be certifie d Halal if not by the bodies contained in the 
list.  Was there a separate list of certifiers for fini shed or retail level goods and, if so, could Indonesia 
publish the list?      
34. The US representative noted that his delegation had not received an official response to a 
letter from USTR, dated 28 September 2009, whic h had addressed many of the above-mentioned 
issues, and asked Indonesia when a response could be  expected.  He also noted that the US was 
unclear on the scope of the regime in Indonesia, whether certification was voluntary or mandatory 
and, if mandatory, what products were covered.  The representative of the United States noted that 
Indonesia and the United States share the common goal of ensuring that foods labelled “Halal” meet 
Indonesia’s requirements; however, the United Stat es believed that Indonesia’s objective could be 
accomplished without disrupting trade.  He stressed th at this would require additional transparency by 
the Government of Indonesia.  Suppliers and certifiers  needed to be made aware of when there would 
be new requirements; they also needed to be ab le to review and comment on such requirements in  G/TBT/M/49  
 Page 9 
 
 
  draft form and have their comments taken into account by the relevant authorities; and they had to be 
provided with a reasonable time period to comply with new requirements.  The US representative claimed that his government continued to seek bilate ral discussions on this issue with Indonesia in the 
near term and requested that experts meet to di scuss the technical details of the Indonesian Halal 
regime to help ensure that leg itimate trade in Halal products was no t further disrupted, for the benefit 
of Indonesian consumers, as well as traders, suppliers, and certifiers.  
35. The representative of Indonesia
 informed the TBT Committee th at their delegation had taken 
note of the concern and that they would work w ith relevant government in stitutions to take the 
necessary actions to resolve the matter.  
(ix) Indonesia – Regulation of BPOM No. HK.00.05.1.23.3516 relating to distribution license 
requirements for certain drug products, co smetics, food supplements, and food  
36. The representative of the United States  raised a concern regarding Indonesia's new 
requirement for producers of food, food supplemen ts, drugs and cosmetics to obtain distribution 
licenses from the National Agency of Drug and Food Control under a measure that was announced on 
31 August 2009.  The United States respected the right of Indonesia to regulate Halal in the 
Indonesian market.  However, this could be done in a way that did not disrupt trade.   As in the case of 
the 9 March decree with respect to Halal certificati on, Indonesia had not provided any notice of the 31 
August decree which had come into effect on the da te it was published.  The US representative said 
that the new requirements were unclear in several re spects and could restrict exports of certain foods 
and food supplements, drugs, such as gelatine capsu les, vaccines, and cough syrups, and cosmetics 
products.  The US representative stressed the im portance of Indonesia suspending implementation of 
the 31 August decree while taking comments into account in revising the measure.  He also noted that 
his country had many questions on how the lic ensing process worked, as the requirements for 
obtaining a distribution license were vague and unclear.  
37. Regarding specific provisions in the decree, th e representative of the United States raised the 
following questions:  how was an emergency determ ined for purposes of the decree, since a license 
would only be granted for pharmaceutical products in  the event of an emergency;  who made this 
determination;  and what were the specific crite ria used in this process.  The US representative 
explained that because little clarifying information ha d been included in the decree, the measure could 
disrupt trade in critical medicines, such as vaccines.  He also noted that vaccines that were developed 
to address a pandemic could contain porcine and thus could be banned in Indonesia under this decree.  
Moreover, because swine sourced, swine derived, and swine containing products in the food and 
beverage sector were also subject to similar em ergency provisions, failure to clarify how these 
provisions operated could block exports of certa in foods and beverages to Indonesia as well.  
38. According to the United States, the appli cation of the current labelling requirements 
suggested the use of a label for products that  were manufactured using swine content.  The 
representative noted that this did not appear to be workable since there appear ed to be no test for 
detecting such materials in drugs.  Additionally, th e decree indicated that the use of traditional drug 
products, cosmetics and food supplemen ts was, in general, not an emergency and therefore it appeared 
that products sourced from, containing, or derived from certain animal substances would 
presumptively not be given a distribution license.  Ho wever, the rule indicated that the use of such 
products could be an emergency in some instances,  but there was no elaboration on what types of 
cases would constitute such an emergency.  Finall y, the representative of the United States claimed 
that his government continued to seek bilateral disc ussions on this issue with Indonesia in the near 
term and requested that the relevant experts meet  to discuss the technical details of the Indonesian 
licensing regime to help ensure that legitimate trad e in food, food supplements, cosmetics, and drugs 
to Indonesia would not be further disrupted.  The United States also noted that it would be providing a 
list of technical questions to Indonesia following the meeting.   G/TBT/M/49  
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  39. The representative from the European Communities
 said that her delegation was also looking 
into the same issue as it had been approached by in dustry. The representative expressed regret that the 
legislation had not been notified under the TBT Ag reement before it had been adopted.  She also 
asked Indonesia to clarify: what would be the emer gency situations in whic h drugs containing certain 
substances would be awarded a distribution license;  what would an evaluation of their safety, use and 
quality entail, who would perform the evaluation and what would be an envisaged time frame.  The 
representative of the European Communities also as ked Indonesia to notify the measure to the TBT 
Committee in order to allow interested Members to provide comments and to take these comments 
into consideration.  Pending such notification the European Communities urged Indonesian authorities 
to suspend the application of the measures and to act ively engage in a dialogue with foreign operators 
to ensure that the measure at issue was not mo re trade restrictive than necessary to achieve its 
objectives.  
40. The representative of Indonesia  noted that concerns expressed by the United States and the 
European Communities relating to the distributi on license requirements of certain drug products, 
cosmetics, food supplements and food and said th at she would discuss the measure with relevant 
agencies in capital and submit responses as soon as possible.  
(x) United States – Country of Origin Labeling for Dairy  
41. The representative of Mexico  noted that on 14 October 2009, Senator Al Franken had 
presented an initiative entitled Dairy COOL, S. 1783 before the US Senate which was intended to 
amend the Agricultural Marketing Act of 1946.  It w as stated that the objectiv e of the initiative was to 
broaden the coverage of country of  origin labelling requirements in order to include dairy products.  
The Mexican representative explained that the Senate  bill established that retailers inform consumers 
about the country of origin of each of the ingred ients as well as where the product was processed.  In 
the case of dairy products produced exclusively in th e United States, the requirement to inform about 
the country of origin of the dairy product could be  done indicating the region, the state or the locality 
where it was produced and as such, it was not necessary to specify the United States as the country of 
origin. 
42. With respect to the initiative, the representativ e of Mexico explained that the coverage of 
products was rather widespread and included, for example, fluid liquid milk, cheese, including cottage 
cheese and sour cream, ice cream, butter and within quotes "any other product".  He highlighted that 
there was no exhaustive list of these "any other produ cts", nor was there a clear specification of the 
coverage of the concept dairy.  If approved, the re presentative from Mexico stated that in terms of 
milk, cream, cheese, powdered milk, fats and dairy content in chocolate, USD119.8 million in exports 
from Mexico to the United States could be affect ed. Moreover, Mexican exporters would have to 
know the origin of each input used in these products a nd state this on the labels and furthermore, keep 
registers of all movements in this area.  He stressed  that this would be very  burdensome for exporters.  
Regarding US producers using Mexican dairy inputs, Mexican exporters would ha ve to inform the US 
customers of the status of each one of the products they were going to sell.   
43. In addition, US producers that used both impor ted and domestic inputs w ould have to have a 
register of the movements of inventory.  This would mean a disadvantage for imported products as 
compared to nationally produced products.  The re presentative of Mexico stated that although this 
measure was still just an initiative, he noted the im portance of such cases in the context of the US 
obligations under the TBT Agreement.  He asked th e United States to keep Members informed about 
the progress of the legislation;  notify it at the a ppropriate stage thereby allowing the opportunity for 
comments;  assess the risks for which this measure was being implemented; and explain the legitimate 
objective that was presumably being sought.  Lastly, regarding the draft law in its current form, he noted that his country thought it was inconsiste nt with the corresponding Codex standard and  G/TBT/M/49  
 Page 11 
 
 
  contained elements which made it inco nsistent with obligations under, inter alia , GATT 1994 and the 
TBT Agreement. 
44. The representative of the United States  noted that this was a new issue that had not been 
previously raised.  He stated that given Mexico's  interest, his delegation would monitor the progress 
of this bill and would be available to discuss this b ilaterally after his delegation had reviewed the issue 
in capital. 
2. Previously raised concerns 
(i) European Communities – Regulation  on the Regi stration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52 and Adds.1-5;  Add.3/Rev.1; G/TBT/N/EEC/295 and 297)  
45. The representative of Cuba
 reiterated his delegation's concer ns with REACH.  While Cuba 
recognized the importance of protecting human health  and the environment, concerns remained about 
the complexity of the REACH regulation, its trad e-restrictiveness and the overall difficulties faced by 
developing countries and least developed countries in its implementation.  Therefore, he asked the 
European Communities to provide technical assistance and to take into account the difficulties faced 
by developing countries in a time of financial crisis. 
46. The representative of Canada  supported the objectives of protecting health and the 
environment, but reiterated her dele gation's concern about REACH.  In the interest of time, Canada 
limited its oral intervention to expressing concern about the treatment of natural vegetable oils 
sourced from genetically modified soybeans, canola and corn under REACH.  In this regard, the 
representative of Canada noted that Article 9, A nnex V of the REACH regulation provided for an 
exemption from the obligation to register under REAC H.  This exemption extended to fats, vegetable 
oils, vegetable waxes, animal fats, animal oils, an imal waxes, fatty acids from C6 to C24 and their 
potassium, sodium, calcium and magnesium salts, gly cerol obtained from natural sources.  However, 
it was Canada's understanding that during recent CA RACAL meetings some EC member States had 
questioned whether vegetable oils sourced from ge netically modified soybeans, canola and corn 
should continue to benefit from this exemption.  The Canadian delegate stressed that industry had 
estimated that a change in this situation woul d result in a need for three thousand additional 
registrations and would cost approximately EUR 35 million.  Most importantly, since none of these 
products were currently pre-registered or registered , trade in oils sourced from genetically modified 
(GM) plants would effectively be halted. 
47. The representative of Canada noted that ge netically modified organisms (GMO) derived 
substances were regulated by specific EU legislatio n.  This legislation required pre-market safety 
assessment of such products before they entered the marketplace for food and feed use.  It was 
Canada's understanding that the safety assessment w as a comparison between the GM product and its 
conventional counterpart, as recommended by the Codex Alimentarius "Principles for the Risk 
Analysis of Foods Derived from Modern Biotechnol ogy" (CACIGL 44-2003).  Canada stressed that it 
would have been disproportionate to re-evaluat e and alter the treatment of these substances under 
REACH.  The European Communities was therefore re quested to provide an update on the status of 
the treatment of oils sourced from GM plants under REACH, and to confirm that it would give serious 
consideration to the views expressed by industry and trading partners. 
48. The representative of Canada then referred to a Room Document providing a summary of its 
outstanding concerns, many of which had previously been raised.  With respect to the issue of the 
Only Representative (OR), Canada remained concer ned that REACH could have a disproportionate 
impact on Small and Medium-sized Enterprises (SMEs), and that the OR requirement was biased against non-EU based companies because of the extr a costs it entailed.  In this regard, Canada G/TBT/M/49  
Page 12  
 
  believed that a company wishing to comply with RE ACH had to either hire an OR, open an office in 
the European Communties, attempt to navigate th e complexity of REACH on its own, or choose to 
abandon the EC market.  In Canada's view, ther e was no option that would not require Canadian 
companies to incur extra costs.  In addition, th e representative of Canada expressed concerns about 
the protection of confidential business information that non-EC firms were expected to provide to 
their OR.  She further noted that the Canadian industry had sought clarification on several issues. 
What would happen if a company wished to set up a distributor in a different EC member State than where their OR was located?  Would that company have  to involve the OR in this new relationship?  
What would happen if a company wished to end the relationship with its distributor in the European 
Communities?  Would it need to transfer its regist ration?  What would the cost be?  Was the OR's 
permission needed in case the distributor was not the same as the OR? 
49. With regard to the subject of test methods , the representative of Canada noted that the 
European Communities would adopt the OECD test sta ndards.  In this regard, she requested that the 
European Communities give the timeline for adopti on of the test methods and clarify what the 
practical consequences would be.  It was also noted  that the European Communities had declared that 
the OECD test standards would be used except in exceptional circumstances.  Canada requested that 
the European Communities clarify what these exceptional circumstances could be and whether they 
would be published.   
50. On the subject of data submitted by industry, Canada believed that i ndustry would be required 
to generate a large amount of scientific data to  demonstrate the safety of their products.  What 
transparency, oversight and peer review measures w ould be put in place to ensure data submitted was 
considered? 
51. With regard to the Substance Information Exchange Forum (SIEF), the representative of 
Canada noted that Canadian companies needed to provide data to ORs which, in turn, could be 
required to report this data to the SIEF.  Since onl y EC-based companies were able to join the SIEF, 
this could cause an unfair, potentially prejudici al one-way flow of information that could 
disadvantage Canadian companies.  Canada requested  the EC delegation to clarify how it considered 
the relationship between mandatory SIEFs, voluntary,  pre-existing industry c onsortia and how the two 
could fit into the REACH framework.  Furthermor e, the European Communities was asked to provide 
details on the cost and data sharing rules applicab le to SIEF and how these rules could apply to Only 
Representatives. 
52. With respect to the issue of authorization and restriction, it was Canada's understanding that 
internal procedures were being developed to operationalize the authorization and restriction 
provisions of REACH.  Canada asked the European  Communities to clarify whether the timelines for 
future submissions of Annex XV dossiers by EC me mbers States or the European Chemical Agency 
(ECHA) had been determined.  Canada also not ed that work packages of substances had been 
developed for the June 2009 REACH meeting of  Competent Authorities (CARACAL) and some 
substances were being considered for authorization.   In this regard, the European Communities was 
invited to provide further clarification.  In partic ular, would EC member States be expected to choose 
which dossier to notify to the Registry of Inten tions (RoI) as the first step in the authorization 
process?  Was it possible to obtain information on th e content of these work packages?  For example, 
were there any nickel-containing substances in these packages?   
53. With respect to the treatment of nanomateria ls under REACH, it was Canada's understanding 
that the Directorate General for Health and Cons umer Affairs (DG SANCO) had held consultations 
on this issue in September 2009.  The representativ e of Canada noted that , on 13 October 2009, the 
European Communities had announced its intention to  review a number of po licies and regulations 
covering health and environmental safety issues rela ted to nanomaterials over the course of the next 
two years.  The European Communities was invited to  clarify whether trading partners were allowed  G/TBT/M/49  
 Page 13 
 
 
  to participate in the consultation and regulatory proc ess related to nanomaterials .  In Canada's view, it 
would be helpful for both the Canadian industry an d regulators to have regul ar consultations about 
risk assessment and management approaches, in  order to encourage cooperation to maximize 
effectiveness of environmental and human health protection measures and minimize potential trade 
issues. 
54. The Canadian representative urged the EC de legation to clarify th e relationship between 
REACH and the directive concerning Restricti ons on Hazardous Substances in electrical and 
electronic equipment (RoHS) and to explain which one would take precedence in case of conflict.  Since industry still faced many problems with the im plementation of this regulation, the Canadian 
delegation hoped that REACH Help Desks would be widely promoted and be responsive to enquiries. 
55. The representative of Argentina
 reiterated his delegation's conc ern with regard to REACH.  
The complexity and lack of transparency of RE ACH showed that this regulation constituted an 
unnecessary barrier to trade.  In general terms,  while Argentina recognized the importance of 
protecting human health and the environment, th e complexity and costs related to REACH were 
excessive and constituted a serious impediment to the continued presence of Argentinean companies 
in the European market.  These difficulties were par ticularly serious for SMEs, which did not have the 
expertise to understand and meet the regulation's requirements.  The representative of Argentina also 
said that the guidance documents on REACH were ex tensive, complex and we re continuously being 
amended.  Serious concerns remained on several issues.   
56. With regard to the registration of substan ces in articles, the representative of Argentina 
requested the European Communities to clarify the content of Article 7.1 (b) of the REACH 
regulation, which stated:  "the substance is in tended to be released under normal or reasonably 
foreseeable conditions of use".  The European Communities was also invited to provide further 
clarification on the operation of the Substance Inform ation Exchange Forum (SIEF).  Furthermore, the 
Argentinean delegate recalled that many compan ies pre-registered subs tances without knowing 
whether they actually needed to be registered.  He  stressed that almost three million pre-registrations 
had been submitted to date.  It was Argentina's understanding that this large number was not a 
symptom of the effectiveness of the system, but rather proof of the confusion generated by REACH.  Furthermore, the representative of Argentina noted  that the burdensome and disproportionate costs 
associated with REACH had severe consequences on SMEs of developing co untries and constituted a 
serious impediment to their continued presence in the EC market.  Finally, the representative of 
Argentina invited the European Co mmunities to provide qualified tec hnical assistance to the private 
sector directly involved in the implementation of REACH.  Argentina believed that this type of 
assistance would be more effective, prompt and precise compared to assistance provided on-line.  It was also emphasized that Article 77 of the RE ACH regulation recognized the need to organize 
technical assistance activities and capacity building in developing countries.  The European Communities were therefore urged to provide appropriate technical assistance and consider more 
flexible deadlines for developing countries. 
57. The representative of Japan
 continued to have concerns about REACH.  In particular, he 
informed the Committee that inspections for importers ’ status of pre-registration in the context of 
ensuring compliance with REACH had been carried out in the United Kingdom, Poland and some 
other EC member States.  Japan was concerned that each EC member State had used different procedures for the confirmation of pre-registration,  including requirements to present pre-registration 
numbers or submit documents to certify that the rele vant pre-registration had been completed.  This 
situation caused uncertainty and confusion among Japanese exporters.  It was Japan's understanding 
that lack of the provisions of the REACH regu lation requiring importers to present relevant 
information on pre-registration had caused the situation.   In this regard, Japan  requested the European 
Communities to standardize the procedures for c onfirmation of pre-registration among EC member 
States and to clarify the relevant information required for inspection. G/TBT/M/49  
Page 14  
 
  58. The representative of the United States
 shared the EC interest in  protecting human health and 
the environment.  However, the United States contin ued to have trade-relate d concerns about REACH 
and its implementation.  The US representative also noted that concerns were continuously raised by 
industry.  Many of these had been already discu ssed by the United States and other Members and 
could be found in the minutes of previous TB T Committee meetings.  The representative of the 
United States reiterated concerns about the differe nt interpretation of REACH provisions across the 
EC member States.  He recalled that six EC member States had expressed disagreement over the 0.1 per cent threshold for the notification and communi cation obligations with respect to substances on 
the candidate list.  In this regard, the United Stat es welcomed the release of the most recent draft 
guidance document from the European Chemical Ag ency (ECHA), which was consistent with the 
legal position of the European Commission.  Howeve r, it was the US understanding that, before being 
submitted to the ECHA Committee's Enforcemen t Forum and to competent authorities for 
endorsement, the guidance document had to under go a limited consultative process in November.  
Could the European Communities confirm the US u nderstanding of this process and clarify whether 
comments on the draft guidance would be sought by ECHA? 
59. The US delegation also reiterated concerns regarding participation in the Substance 
Information Exchange Fora.  Several US compani es had indicated that SIEFs were not functioning 
effectively and that frequently no company wanted to  serve as the lead registrant.  US industry had 
also indicated that many SIEFs were non-functional and would not finish their work in time to meet 
the November 2010 deadline for registration.  Concer ns also remained regarding the  obligation for 
foreign companies, unlike their Eur opean competitors, to delegate their participation in the SIEFs to 
their Only Representatives (ORs).  The US dele gation asked the European Communities to clarify 
what actions were being taken to address these issues.  Furthermore, US suppliers had noted that they 
were unable to change ORs due to technical probl ems with the ECHA website.  The US delegation 
sought confirmation that ECHA was working on a solution to fix these technical problems and that, in the meantime, an interim solution was in place. 
60. With regard to the enforcement of REACH, it was the US understanding that the European 
Commission had sent formal letters to initiate in fringement proceedings to EC member States who 
had not notified their enforcement measures by the 1 December 2008 deadline.  The US delegation 
asked the European Communities to pr ovide an update on the status of this process.  Finally, concerns 
remained about the impact of REACH on animal testing.  The United States noted that ECHA had 
recently issued a press release on avoiding dupli cative testing on animals and sought further 
clarification on this. 
61. The representative of Thailand
 shared the concerns expressed  by previous speakers about 
REACH.  She was particularly concerned about the impact of REACH on SMEs.  
62. The representative of Saudi Arabia  reiterated his delegation's c oncern with regard to REACH 
and noted its potential to disrupt trade in chemi cals.  He was particularly concerned about the 
following issues:  the complexity of the REACH re gulation;  the different implementation of REACH 
provisions across the European Communities;  the lack  of clarity with respect to the penalties for non-
compliance to REACH;   the protection of confidential business information;   the ambiguity on registration requirements for monomers and polymer s;  the burdensome costs and overly restrictive 
procedures associated with REACH.  In conclu ding, the Saudi Arabia representative urged the 
European Communities to take into considerati on the concerns which had been expressed by WTO 
Members, and to ensure that REACH was fully co nsistent with their obligations under the TBT 
Agreement.   
63. The representative of Australia
 reiterated her delegation's c oncern about REACH and noted 
its potential to disrupt and impede global trade in chemicals.  While Australia recognized the 
importance of ensuring a high standard of protec tion for human health and the environment, the  G/TBT/M/49  
 Page 15 
 
 
  uncertainty about the process and implementing rules of REACH remained a concern.  As a member 
of the Asia-Pacific Economic Coope ration (APEC) Chemical Dialogue, Australia shared the concerns 
raised by the APEC Chemical Dialogue in its le tter sent to ECHA on 18 Se ptember 2009.  Australia 
was particularly concerned about the impact of  REACH on small and medium-sized enterprises and 
the lack of assistance to non-EU enterprises in th e implementation of REACH.  Concerns also 
remained about the custom clear ance procedures and the penalties fo r non-compliance with REACH.  
The representative of Australia further noted that industry was concerned th at intellectual property 
rights could be infringed and confidential formulae be  disclosed if enterprises were to comply with 
REACH registration requirements.  She also echoed th e concerns expressed by Canada with regard to 
the treatment of natural vegetabl e oils sourced from genetically modified soybeans, canola and corn 
under REACH.  Finally, the European Communities was urged to take into consideration the concerns 
expressed by Members about REACH. 
64. The representative of Chile  thanked the European Commun ities for the responses to the 
comments previously made on REACH.  However, concerns remained about several issues.  In 
particular, he stressed that the REACH regulati on remained complex, extensive and confusing, 
especially for small and medium-sized enterprises (SMEs).  He also recalled that part of the regulation 
was ambiguous and that some issues of very high concern for Members had not been clarified by the European Communities.  Furthermore, the representa tive of Chile highlighted the difficulties and the 
costs imposed by the registration procedure, especia lly for SMEs of developing countries.  In this 
regard, he requested the European Communities to pr ovide clarification on the exact costs involved in 
the registration of substances.  Concerns remained al so about the lack of technical assistance provided 
to Members in the implementation of REACH.  For example, because companies often were unsure 
whether or not to pre-register a substance, they often pre-registered many more substances than necessary – this entailed burdensome costs for data generation.   
65. Concerns also remained on the lack of clarity on penalties for non-compliance with REACH.  
The representative of Chile recalled that the re sponsibility for the formulation of penalties under 
REACH fell under the competences of each EC member  State, but only Spain, Sweden, Germany and 
the United Kingdom provided information about th is.  The European Communities was therefore 
urged to take these concerns into account and cl arify what the penalties for non-compliance with 
REACH were.  Finally, the representative of Chile  reiterated concerns about the protection of 
confidential business information in the pre-registra tion process.  In this regard, his delegation had 
been informed that the strictly confidential in formation of a Chilean copper exporter had been 
disclosed to all participants of the relevant Subs tance Information Exchange Forum.  It was further 
noted that this information could be freely obtained by all participants of the above-mentioned SIEF.  
The representative of Chile stressed that this system enabled competitors to  access sensitive 
information. 
66. The representative of China
 shared the comments raised by previous speakers about REACH.  
China was particularly concerned about the slow  progress of the Substance Information Exchange 
Forum and its consequent impact on trade in chemic als.  China noted that the Substance Information 
Exchange Forums were of critical importance for industries to communicate and collect data for the 
registration process.  SIEFs were also fundame ntal for industry of developing countries and 
particularly SMEs to formulate joint registration submissions and share the costs of registration, thereby reducing registration fees.  In this regard, the representative of Chin a stressed that difficulties 
in the implementation of SIEFs could result in re gistration delays and create unnecessary restrictions 
to trade.  The European Communities was therefor e urged to take these concerns into account and 
promote the operation of SIEFs. 
67. The representative of Colombia
 echoed the comments made by previous speakers and 
reiterated her delegation's concern about the REACH regulation.  In particular, she expressed concern 
about the impact of REACH on SMEs. G/TBT/M/49  
Page 16  
 
  68. The representative of the European Communities
 recalled that several concerns about 
REACH had already been raised and discussed at previous meetings of the TBT Committee. She 
referred to previously provided an swers recorded in the minutes.   
69. On the current state of play of the procedure concerning substances subj ect to authorization, 
the EC representative informed th e Committee that fifteen new Subs tances of Very High Concern 
(SVHCs) had been identified by ECHA to be include d in the candidate list according to the procedure 
established by Article 59 of the REACH regulation.  Therefore, the current candidate list contained 
the fifteen substances previously identified and fi fteen other new substances were proposed to be 
included.  The EC delegate stressed that stakehol der consultations had been carried out in September 
and October 2009 and that comments received during this consultation would be taken into account. 
70. The European Communities also recalled that an  important deadline for the implementation 
of REACH was on 30 November 2009.  First, this wa s the deadline for downstr eam users of chemical 
substances to inform their suppliers of the use they made of a substance.  In other words, downstream 
users who wanted their supplier to c onsider the use of a substance in relation to its registration had to 
inform their supplier about the use they made of such substance.  If a substance needed to be 
registered before 1 December 2010, the deadline fo r the user communication was 30 November 2009.  
Second, this was also the deadline for late pre-regi stration of certain chemical substances.  In this 
regard, the EC representative referred to Article 28.6 of the REACH regulation, which outlined the 
conditions for late pre-registration.  Further info rmation about these deadlines could be found in the 
press releases recently published on the ECHA website.4 
71. On the Substances Information Exchange Foru m, the EC delegation stressed that ECHA 
continued to effectively assist SIEFs and lead regist rants.  It was also recalled that ECHA had recently 
organized several events on this issue.  In this regard, the Committee's attention was drawn to a lead 
registrant workshop held in September 2009 and to  on-going web conferences for lead registrants.  
The EC delegate also noted that an exchange platform where lead registrants could discuss SIEF-
related issues was available on the ECHA website.  She stressed that since the start of ECHA's 
awareness campaign the number of lead registrant s had steadily increased. On the issue raised by 
Chile about the protection of confidential inform ation in SIEFs, the EC representative noted that a 
press release had been published by ECHA on 30 Ju ly 2009 and urged Members that encountered 
similar problems to inform the EC delegation.   The European Commun ities stressed that the 
protection of confidential information was a key c oncern during the legislative process leading to the 
adoption of the REACH regulation and that there w as neither an obligation to provide SIEFs with 
confidential business information on substances, su ch as their specific use, volume, suppliers, 
formulas, markets strategies.  Furthermore, the EC representative noted that opt-out possibilities for 
joint submission were possible according to Article 11 of the REACH regulation.  Guidance documents on data sharing had been made available on the ECHA website. 
72. On the issue of uniform implementation of REACH across the European Communities, the 
EC representative reminded Members that enfor cement laid with the EC member States. She 
informed Members that, in order to coordinate  and harmonize the enforcement of the REACH 
regulation, a Forum for Exchange of Information on Enforcement had been established by ECHA.  In 
this regard, she announced that the issue of REAC H enforcement would be discussed during the Third 
Stakeholders Day to be held on 7 December 2009.  Concerned Members were invited to participate in 
this event, which would also be web streamed and afterwards available on the ECHA website.  
Regarding the concerns on the disclosure of the pr e-registration number of chemical substances, the 
EC representative recalled that they had been ta ken into account and were still being examined.  
                                                     
 
4 http://echa.europa.eu/   G/TBT/M/49  
 Page 17 
 
 
  73. On the issue of penalties for non-compliance to REACH, the representative of the European 
Communities stressed that clarification had already been provided at previous meetings of the TBT 
Committee.  In this regard, she emphasized that th e monitoring of the European Commission had been 
effective and that only two EC member States had not yet adopted the relevant sanctions. 
74. On the treatment of natural vegetable oils s ourced from genetically modified plants, the EC 
representative confirmed that the issue was s till under discussion and reassured Members that the 
European Communities was aware of the urgency of this matter.   
75. On the issue of monomers in polymers, th e representative of the European Communities 
informed Member of the Committee that the judgeme nt of the European Court of Justice had been 
issued on 7 July 2009.5  She noted that the European Court of Justice had confirmed that Article 6.3 of 
the REACH regulation on the registration of r eactive monomers and polymers was valid.  In 
particular, the judgement confirmed that this pr ovision legitimately pursued the objective of human 
health and environment protection.  Moreover, th e registration obligation enabled better knowledge of 
polymers and addressed certain health and envi ronment risks such as monomer residues.   
76. With regard to the comments made by Arge ntina and the United States on the content of 
Article 7.1 (b) of the REACH regulation, the EC re presentative invited concerned Members to refer to 
the available guidance documents.  With regard to the questions made on animal testing under 
REACH, she referred to the two press releases rece ntly released by ECHA.  With regard to the 
comments made by the United States on technical problems encountered on the ECHA website, the EC representative explained that the issue was under c onsideration.  She further clarified that the Only 
Representative change was one of the functionalities th at would be made available in the legal entity 
change module that was currently being implemente d and was planned to be released with REACH-
IT in 2010.  Finally, regarding the requests for tec hnical assistance, the EC representative recalled that 
WTO Members having specific needs for technical a ssistance programmes should direct their requests 
to the respective delegations of the European Co mmunities in their country.  She invited Members 
who considered that appropriate assistance had not been provided to clarify whether specific requests 
had not been adequately followed up. 
77. The representative of Argentina
 thanked the European Communities for its response.  
However, he reiterated his delegati ons' concern with regard to the content of Article 7.1 (b) of the 
REACH regulation. 
78. The representative of the European Communities  stressed that detailed guidance documents 
on Article 7 of the REACH regulation were availabl e on the ECHA website.  However, the European 
Communities was ready to further di scuss the issue with Argentina if specific concerns still remained. 
(ii) European Communities – Regulation on Certai n Wine Sector Products (G/TBT/N/EEC/15, 
Corr.1-2, G/TBT/N/EEC/57 and G/TBT/N/EEC /252 and Add.1 and G/TBT/N/EEC/264 and 
Add.1)  
79. The representative of New Zealand  reiterated concerns raised at the previous TBT Committee 
meeting in June 2009 regarding the European Commun ities’ new regime for the regulation of its wine 
market, which in turn affected wi ne trade to the European Communiti es.  In particular, New Zealand 
requested clarification following the EC notifi cation of their new labelling regulations.  While 
clarification had been received in a number of area s, some aspects of the regulations still remained 
unclear, such as the mechanism during the transition period by which third countries could notify the 
European Commission of their intention to use certain  wine grape variety names so that they were not 
disadvantaged vis-à-vis European Community pr oducers.  Other open questions concerned the 
                                                      
5 Case C-558/07. G/TBT/M/49  
Page 18  
 
  traditional terms as well as bottle shapes and closur es.  She stressed that New Zealand’s assumption 
remained that the new EU wine regulation, implementing regulations  and any transitional 
arrangements included in these regulations - particul arly those relating to wine labelling -  would 
result in rules for the wine trade that fully complie d with the provisions of the TBT Agreement as well 
as other principles and disciplines contained in other relevant WTO agreements.  New Zealand 
therefore expected that there should be no adverse effect on market access for non-members of the EU  
as a result of the implementation of the regulation.   
80. The representative of Argentina
 reiterated concerns with regard s to the intention of a number 
of EC member States to protect the use of a number of traditional expressions in all languages of the European Communities.  Independent of the s ubsequent amendments and annulments to the 
regulation 753/02 and 316/04 and i ndependent the provisions of the new regulations, Argentina was 
still concerned that several restrictions remain ed on the right to use a number of traditional 
expressions on the labels of non-Community wines, a nd therefore maintained its previously raised 
objections.  He recalled that in the TBT Co mmittee meeting of March 2009, the European 
Communities had explained that the new regulation a llowed use of traditional expressions on products 
from third countries as long as they fulfilled identical or equivalent requirements that were imposed 
on EC member States.  However, in document G/ TBT/W/290 in June 2008, Argentina had observed 
that the European Communities had not yet est ablished a common definition of the additional 
comments of quality or additional information on qua lity.  Argentina had therefore argued that it had 
been impossible to request the certification of fulf ilment of an unequivocal single community criterion 
on this matter. Furthermore, Argentina was of the vi ew that the additional information on quality, like 
other traditional expressions, referred to specific pr oduction or quality methods and therefore could 
not be protected as intellectual property rights under the TRIPS Agreement. He emphasized that 
Argentina did not see any logical, legal or specific grounds under which the EC could claim exclusive 
rights over traditional expressions and was not satisfi ed with the response provided by the European 
Communities on 9 September 2008.  
81. The representative of Argentina recalled that at the July 2008 meeting of the TBT Committee, 
the European Communities had recognized that th ey had detained a shipment of wines from 
Argentina and had invited Argentina to present an  application for conformity with Art. 24 of 
Regulation 753/2202. In response to this invitatio n and in order to avoid future detention of 
consignments, the European Communities were requ ested to register the use of the expressions 
"vintage" and "special vintage" on labels coming fro m Argentina.  He noted, however, that Argentina 
considered the restrictions to the use of trad itional expressions as not compatible with the TBT 
Agreement and therefore requested the revision of the regulations in order to bring them into 
compliance with the TBT Agreement. In addition,  he urged the European Communities to provide 
information on whether other traditional expression s had been the subject of border controls.  
Furthermore, the delegate requested that the European Communities report back to the TBT 
Committee on the detentions that had been operated on other wine shipments from other origins since 
2008 as a result of the implementation of regula tions 753/02, the amendments thereof and the 
regulations that had subsequent ly replaced that regulation. 
82. The representative of the United States
 reiterated serious concerns  regarding the EC measures 
at issue.  The measure severely restricted the ability of non-EU wine producers to use common or 
descriptive and commercially valuable terms to de scribe their products, on the grounds that those 
terms were traditionally associated with European wi nes.  He explained that this was particularly 
worrisome when some of these terms did not have a common definition across all EC member States; moreover, the United States was not aware of efforts to monitor or limit the use of those terms within 
the European Communities.  He in formed the Committee that the Un ited States remained concerned 
with respect to negative trade impacts resulting from the termination on 10 March 2009 of the three-
year derogation for the use of such terms on th e labels of US wines sold in the European  G/TBT/M/49  
 Page 19 
 
 
  Communities, as well as the EC’s recognition of so-called traditional expressions contained in 
trademarks.  
83. The delegate of the United States noted th at while draft Regulation EEC/264 had been 
replaced by an amended regulati on, No. 607/2009 of 14 July 2009,  the United States continued to 
have concerns about several issues in Regulati on EEC/264 and that bilateral discussions with the 
European Communities in October 2009 had failed to resolve these concerns. It appeared that the 
European Communities was still trying to claim ex clusive rights to use terms commonly included on 
the labels of wines in the EC, such as “chatea u”, “vintage” and “superior”, except under certain 
limited circumstances, in which the exporting country regulated the use of the terms to the satisfaction 
of the European Communities.  He argued that wh ile the European Communitie s attempted to justify 
limitations on the use of traditional terms by indicati ng that consumers could be misled by their use, 
the fact that these terms had been used without inci dent on US wines in the EU market for many years 
suggested that there was no risk of misleading c onsumers.  Adding to US industry concerns was the 
fact that the European Communities had not indicated  how it intended to enforce the limitations with 
respect to imported wines.  For example, would the EC member States take action to block 
importation of US wines bearing a traditional expression?  Furthermore, he noted that the European 
Court of Justice had expanded the scope of the me asures and, contrary to the assurances provided by 
EC officials, the traditional terms were also prot ected in languages others  than the ones for which 
protection was identified.  In addition to TBT-relate d aspects of the EC regulation, the delegate of the 
United States also had concerns about provisions of the new regulation regarding the protection of 
trademarks and intellectual property, which it ha d been raising with the EC in other fora. 
84. The representative of Mexico  announced that his delegation associated itself with the 
statements made by previous speakers. 
85. The representative of th e European Communities  stated that the new implementing provision 
on protected designations of origin and geographi cal indications, traditional terms, labelling and 
presentation of certain wine sector products had en tered into force on 1 August 2009, including a 
transitional period for the entry into force for some  of the requirements.  She recalled that several 
modifications had been made to the text that ha d been notified to the TBT Committee to take into 
account the comments received from different WTO Me mbers and bilateral discussions had also been 
held to clarify these issues.  She also noted that a detailed reply to clarify the outstanding issues had 
been sent to delegations that had submitted comments in writing..  
86. The representative of the European Communiti es recalled that the new implementing rules 
allowed the use of traditional terms on third countr ies’ products provided they fulfilled the same or 
equivalent conditions to those re quired from EC member States in order to ensure that consumers 
were not misled.  She explained that the competent authorities of member States or third countries or 
representative professional organizations established in  third countries had the possibility to submit to 
the European Commission an application for the pr otection of traditional terms.  She informed the 
Committee that the European Commi ssion had already received applications by third countries and 
was currently examining them.  In this respect, the Commission was already in touch with Argentina 
at a technical level in order to prepare the formal  applications and technical discussions were ongoing 
as well with US industry.  Regarding the comment  made by Argentina on the enforcement of the 
regulations, she recalled that the importers had always been inform ed when a consignment had been 
detained but this information could not be shared with other countries as it was confidential.  Finally, 
she invited all delegations interested in having thei r traditional expressions authorized in the European 
Communities to contact the respective competen t authorities of the European Communities. 
(iii) European Communities – Directive 2002/95/EC on the Restriction of the Use of certain 
Hazardous Substances in Electrical and El ectronic Equipment (RoHS) and Directive 
2002/96/EC on Waste Electrical and Electroni c Equipment (WEEE) (G/TBT/N/EEC/247 and G/TBT/M/49  
Page 20  
 
  G/TBT/Notif.00/310, Corr.1)  
87. The representative of the United States
 drew the Committee's attention to the European 
Communities' review of the directive concerning Re strictions on Hazardous Substances in electrical 
and electronic equipment (RoHS).  He emphasized that the United States supported the objectives of 
measures taken to protect human health, safety an d the environment, and noted his delegation's 
appreciation for the improved transparency and the broader consultations w ith stakeholders that 
characterized the RoHS revision process.  The US representative highlighted the need for continued  
transparency in the implementation and operation of the proposed RoHS revision, including by 
continuing to take into account comments from a ll stakeholders.  Furthermore, he stressed the 
importance of providing adequate le gal certainty to stakeholders re garding how substances would be 
treated. He emphasized that any selection and assessme nt procedure, under RoHS or REACH, needed 
to be science-based and take into account intend ed end uses as well as all available scientific and 
technical information. 
88. It was the US understanding that the EU Council was considering a new proposal to include 
all electrical and electronic equipment under the scope  of RoHS.  Since this proposal could have an 
impact on producers who were not aware that thei r products could be covered by RoHS, the United 
States invited the European Communities to provide an update on its status.  Would the European 
Communities solicit comments from interested stake holders through a new WTO notification?  The 
United States also understood that the EU Council w as considering a proposal to modify the criteria 
for restrictions and exemptions, as well as the link between REACH and RoHS.  The United States noted that the above-mentioned proposals had been  made after the comment period set out in the 
WTO notification had expired.  In addition, the US  representative noted that the Netherlands had 
recently tabled a non-paper about the interrelati onship between RoHS and REACH, and press reports 
indicated that EC member States were discussing how to avoid overlaps between  the two regulations.  
The United States sought an update on the current status of these issues an d asked the European 
Communities to clarify how the EC would solicit input on them. 
89. The representative of the United States recalle d that his delegation had submitted detailed 
comments in writing on the notified proposal and ur ged the European Communities to take these 
comments into account.  He also asked the EC de legation whether these comm ents had been shared 
with the EU Council and the European Parliament.  The European Communities was urged to ensure 
that a transparent and predictable process be put in place for the treatment of exemptions and to 
consider  providing an exemption period for medica l devices that would take into account the product 
development cycle.  This would help to ensure long-term investments in new devices and innovations 
that were critical to hospitals, doctors, and patie nts in the European Communities.  Finally, the US 
representative reiterated his delegation's interest in setting up a meeting of experts to review the US 
comments and concerns. 
90. The representative of Japan
 echoed the concern raised by the United States and invited the 
European Communities to provide an update on the current status of the proposed revision of RoHS. 
91. The representative of the European Communities  thanked the delegations that had submitted 
comments on the revision of the RoHS Directive and stressed that written replies had been recently 
provided.  She also recalled that an extensive e xplanation of the proposed RoHS recast had been 
provided at the previous meeting of the TBT Committee.6  On the current state of play of the revision, 
the EC representative noted that the notified proposal was being discussed by the European 
Parliament and the Council in the "first reading" of  the legislative process.  Within this procedure, 
amendments had been tabled by the Parliament and the Council and were currently under discussion.  
The EC representative confirmed that proposals had b een made to include all electric and electrical 
                                                      
6 G/TBT/M/48, p. 26.  G/TBT/M/49  
 Page 21 
 
 
  equipment under the scope of RoHS.  She informed the Committee that a public debate on the scope 
of RoHS had been held on 21 October 2009.  During  this debate, the European Commission had noted 
that the issue was still under discussion and that an  impact assessment on this proposal was being 
prepared by Denmark.  The EC representative further clarified that the vote on the first reading had been tentatively scheduled for May 2010.  
92. With regard to the concerns raised on the valid ity of exemptions for medical devices, the EC 
delegate clarified that exemptions  were temporary derogations from a ban granted to manufacturers to 
facilitate the transition to substa nce-free products in cases where substitutes were not available.  The 
representative of the European Communities noted th at the exemption was valid for four years but 
also clarified that this four year period could be  prolonged if stakeholders could prove that the 
exemption was still justified. 
93. With regard to the link between RoHS and RE ACH, the European Communities clarified that 
the RoHS directive and the REACH regulation were complementary.  While REACH focused on chemical substances, RoHS dealt only with h azardous substances in electrical and electronic 
equipment.  If a substance subject to authoriza tion under REACH was also restricted under RoHS, it 
would be exempted from REACH obligations.  Furthe rmore, the EC representative stressed that the 
European Commission was exploring all possible sy nergies to improve the correlation between the 
two measures.  Finally, she reassured Members th at the European Communities would notify to the 
WTO the text of the proposed measure in case of substantial amendments.  Her delegation remained open to further bilateral discussions with interested Members. 
(iv) India – Pneumatic tyres and tubes for auto motive vehicles (G/TBT/N/IND/20 and Add.1) 
94. The representative of Japan
 referred to the above-mentioned TB T notification that stated that 
the relevant provisions would come into force on completion of 120 days after its publication in the 
Official Gazette. Japan considered that a period of 120 days was too short and requested India to grant 
a longer time period to comply with the new require ments. He recalled that Japanese industry had not 
yet received a reply to their petition submitted to India in April 2009 and urged India to reply to  that petition as early as possible.  Furthermore, th e representative from Japan asked for further 
clarification by India concerning the corresponding c onformity assessment procedure.  In particular, 
referring to the minutes of the previous Committee m eeting, he asked about the detailed procedures 
on how test reports from accredited laboratories ab road could be accepted provided that they 
complied with ISO
7/IEC8 17025 and were accredited by a body which was a part of the Mutual 
Recognition Agreements with the International Laboratory Accreditation Cooperation (ILAC) on a 
reciprocal basis.  He also asked about the how India was considering these issues.   
95. The representative of th e European Communities  echoed the concerns expressed by Japan on 
the Indian proposal for tyres and tubes for automo tive vehicles that was notified as an addendum in 
May 2009. The delegate referred to the concerns expressed by the European Communities at the last 
TBT Committee meeting as well as its previous requests for certain clarifications.  Furthermore, the 
European Communities had sent written comments to  the Indian TBT Enquiry Point on 2 July 2009 
without having received a reply.  The European Co mmunities therefore requested India to reply to the 
comments made or to provide answers at the TBT Committee meeting, since the answer provided at 
the last Committee meeting did not seem to relate to the revised version of the text.  Finally, the 
European Communities requested clarification by In dia on the timing with regard to the adoption and 
the entry into force of the notification. 
                                                      
7 International Organization for Standardization 
8 International Electrotechnical Commisssion G/TBT/M/49  
Page 22  
 
  96. The representative of the United States
 noted that his delegation was also following these 
issues and continued to seek bilateral discussions with India. 
97. The representative of India  informed the Committee that India had decided to postpone the 
implementation of the new regulati on; he welcomed further bilateral discussions with concerned 
delegations. 
(v) United States – Country of Origin Labelling (G/TBT/N/USA/25, G/TBT/N/USA/83 and 
Corr.1, G/TBT/N/USA/281 and Adds.1-4) 
98. The representative of Australia  expressed concerns with respect to the potential trade 
restrictive nature of the United States Department of Agriculture's Final Rule on Mandatory Country 
of Origin Labelling (MCOOL), which had entered into force on 16 March 2009. In particular, 
Australia was concerned that the administra tion of MCOOL imposed additional costs on US 
processors and could create incentives for tho se processors to favour domestic over imported 
products. The delegate from Australia informed the Committee that a preliminary trade analysis since 
MCOOL's implementation indicated that it was ha ving a negative trade impact on Australian beef 
exports. She therefore requested advice from the United States about what measures it had 
implemented to assist the US industry transition to the MCOOL in order to ensure there was no 
adverse trade-restrictive outcome. In general, Au stralia was supportive of country of origin labelling 
and believed that it was a legitimate means of provid ing relevant information to consumers. However, 
Australia considered that MCOOL could be implemen ted in a less trade restrictive manner. Australia 
appreciated the opportunity to discuss these issues bilaterally with the United States and announced 
that Australia would closely monitor MCOOL's ongo ing trade impact on Australian exports. Australia 
was also aware that both Canada and Mexico had initiated dispute settlement proceedings against the 
United States over MCOOL. 
99. The representative from Mexico  noted that the dispute settlement proceedings initiated by 
Mexico concerned that 1783 decision called the Da iry COOL Act of 2009 and was unrelated to the 
MCOOL raised by Australia. 
100. The representative of the United States  recalled that it was common for WTO Members to 
require that goods be labelled as to their origin.  The United States was confident that its measures 
provided information to consumers in a manner consistent with its WTO commitments.  He informed 
the Committee that Canada and Mexico had request ed that a WTO dispute panel be established to 
examine the matter, and that the pa nel process was currently underway. 
(vi) European Communities – Regulation on Cla ssification, Labelling and Packaging of 
Substances and Mixtures (ATPs and CLP) (G/TBT/N/EEC/151 and Adds.1-2; 
G/TBT/N/EEC/212 and Adds.1-3; G/TBT/N/EEC/163 and Add.1-2, Add.1/Corr.1) 
101. The representative of Cuba  reiterated his delegation's concer ns regarding the adoption of the 
31st Adaptation to Technical Progress (ATP) to the Dangerous Substance Directive 67/548/EEC 
(DSD) and its incorporation into the 1st ATP to the regulation on Classification, Labelling and 
Packaging of substances and mixtures (CLP).  As stated previously, Cuba's main concerns were 
related to the incorrect application of the OECD methodology, referred to as "read-across", which had 
been used as the basis fo r reclassifying 117 nickel compounds.  It was Cuba's view that this decision 
was based on questionable scientific and procedural  grounds.  For example, the representative of 
Cuba stressed that some of the scientific eviden ce on which the European Commission had based this 
decision, such as skin sensitivity to oxide compounds , differed from the evidence used for registration 
purposes under REACH.  The European Communities was therefore urged to apply the read-across 
methodology in a scientifically sound manner and follow the relevant  guidelines established by the 
OECD.  G/TBT/M/49  
 Page 23 
 
 
  102. The representative of Cuba drew the attention of the Committee to the timetable established 
by the European Communities for the adoption of the 31st ATP.  He considered that the European 
Communities did not allow sufficient time for consultations  to be held.  In particular, he noted that the 
Technical Progress Committee (TPC) approved the 31st ATP on 19 November 2008, within 24 hours 
of the end of the notification comment period.   His delegation believed that the European 
Communities did not have time to take into acc ount the comments provided by other WTO Members 
the day before.  Moreover, Cuba was concerned a bout the absence of a notification and consultation 
on the 1st ATP to the CLP regulation.  In this regard, the Cuban delegate stressed that new criteria for 
assessment had been included in this regulation, which constituted a new regulatory framework.  He 
also recalled that the 31st ATP had been adopted despite calls from several delegations, including 
developing country Members, for a postponement of its entry into force. 
103. In addition, contrary to previous EC statements to the effect that the 31st ATP only related to 
labelling and would not result in bans or restricti ons on the use of chemical substances in consumer 
products, the sale to the general public of substa nces classified as carcinogenic Category 1A and 1B 
had been prohibited.  Cuba also stressed that th at new studies on the toxicity of nickel compounds 
were expected to be published in the coming mont hs by the Nickel Agency and the International 
Agency for Research on Cancer  (IARC), and asked the Europ ean Communities to postpone the 
implementation of the 31st ATPs until such studies were made av ailable.  While Cuba recognized the 
importance of protecting human health and the envi ronment, the EC measure appeared to create an 
unnecessary obstacle to trade within the meaning of Ar ticle 2 of the TBT Agreement, as it restricted 
trade beyond necessary levels to achieve its legitima te objective.  Finally, concerns were reiterated 
about the negative impact that the 31st ATP would have on the demand for nickel, particularly for 
developing country Members such as Cuba whic h were highly dependent on nickel exports.   
104. The representative of Canada  reiterated her delegation's disappoi ntment that, despite repeated 
expressions of concern from Canada and the interna tional nickel industry, the European Communities 
had proceeded towards the adoption of the 1st ATP to the CLP regulation.  Furthermore, Canada noted 
that, despite the EC’s characterization of nickel  classifications as "mere labelling requirements", 
concerns on their downstream impact were longstandi ng and had yet to be allayed.  In fact, the 
reclassification of nickel substances had already st arted to have an impact:  for example, recently 
amended EC legislation on toys had resulted in a complete ban on nickel substances classified as 
carcinogenic Category 1 under the 30th and 31st ATPs to the DSD.  The Canadian delegate also noted 
that nickel substances had been added to the so- called "Substitute It Now" (SIN) list drawn up by a 
coalition of environmental campaign groups, which was aimed at speeding up the implementation of 
REACH.  Additionally, nickel metal producers we re currently being asked to certify that their 
products did not contain the substances cl assified as carcinogenic under the ATPs.   
105. Given the potential of negatively impacting nickel producers and exporters, it was essential 
that any classification of substances was transpar ent and based on sound science, regardless of what 
legislation or regulation they were made under.  To this end, Canada sought assurances that the 
European Communities would give serious consider ation to the research data that industry was 
producing as part of the REACH registration process, as well as other relevant sc ientific information, 
and that in light of this info rmation the European Communities would review the classifications of 
nickel in a transparent manner.  Finally, the repr esentative of Canada noted that, like all Members, 
Canada shared the EC commitment to the protecti on of human health and the environment.  This 
commitment, however, did not diminish Canada’s concerns regarding the trade impacts the EC’s 
classification of nickel could have, particularly since the potential trade restrictiveness of the measures flowing from these classifications remained to be seen.  Canada would therefore continue to closely monitor the EC’s regulation and risk ma nagement of nickel substances and urged the 
European Communities to ensure  that any measures taken did not create unnecessary obstacles to 
international trade.  G/TBT/M/49  
Page 24  
 
  106. The representative of Brazil
 regretted that the 1st ATP to the CLP regulation had been adopted 
without taking into account the many concerns raised by WTO Members about the inadequate 
classification of nickel compounds.  In Brazil's view , the European Communities had failed to give 
satisfactory answers to questions on several aspects of  the process, such as:  (i) the data on which the 
classifications was based;  (ii) the use of water so lubility as the sole criterion for grouping substances;  
(iii) the trade consequences of the measure.  Rega rding the latter, Brazil noted that in statements 
provided at previous meetings of the TBT Committee, the European Communities had assured Members that the new classification of nickel compounds only related to labelling and would not 
result in bans or restrictions on the use of chemi cal substances in consumer products.  However, the 
European Communities had recently notified to the TBT Committee a proposed amendment to the 
REACH regulation (G/TBT/N/EEC/297), which proh ibited the sale of a number of newly classified 
carcinogenic, mutagenic and reprotoxic (CMR) subs tances, including nickel compounds.  Therefore, 
the European Communities was request ed to take into account any new data available on the risks of 
these substances and to review the 1
st ATP with a view to avoiding unnecessary obstacles to trade. 
107. The representative of Japan  raised concerns about the application by the European 
Communities of the CLP regulation.  He noted th at, following the adoption of the CLP regulation, 
both the classifications based on the Dangerous Substances Directive and the Globally Harmonised 
System (GHS) were used as transitional measures.  He  also noted that during this transitional period 
certain substances were temporarily required to be  classified and labelled as "explosive" with the 
revision of the DSD.  Japan stressed that the co st of compliance with this new requirement would 
create an excessive and unnecessary burden for industries and could disrupt trade in chemical 
products.  The European Communitie s was therefore requested to en sure that the system did not 
require handling based on the temporary classification only applicable during the transitional period.  
In addition, the representative of Japan noted th at the CLP regulation required all components in a 
mixture classified as hazardous substances to be no tified when a mixture was imported to an EC 
member State. However, since mixtures usually contained several different components, Japan was 
concerned that several notifications had to be submitted for the same mixture. Japan was also 
concerned that non-EC manufacturers were required to  provide importers which notify substances in 
EC with details on the composition of the importe d mixture and consequently disclose confidential 
business information.  For the above-mentioned reas ons, the representative of Japan believed that the 
EC measure substantively discriminated agai nst non-EC producers and urged the European 
Communities to take these concerns into account when implementing the regulation. 
108. The representative of the United States  noted that, in light of the most recent risk assessment 
commissioned by the European Commission, borate u sage in the cases examined either did not pose a 
risk to the general public, or the risk was negligible .  He welcomed that, as a result of this study, it had 
been proposed that the placing on the market and use of borates-containing substances in household 
cleaners, detergents and certain photographic mixtur es should not be restricted.  However, the US 
representative reiterated his delegation's concerns about certain aspects of the 30th and 31st ATPs to 
the DSD, as well as the subsequent classification of borates and certain nickel compounds under the CLP regulation without further analysis or notification. 
109. The representative of the United States noted that in its analysis of certain nickel compounds, 
the relevant competent authority ap peared to skip certain steps when  applying the OECD read-across 
methodology, which raised questions as to whethe r the European Communities adequately took into 
account available scientific and technical informatio n and intended end-uses of the relevant nickel 
compounds.  Since nickel compounds were used for ma ny important applications, this issue was of 
great concern to the nickel plating industry and customers in the automotive and other industrial 
sectors.  The EC recently provided additional informa tion in this regard, which the United States will 
investigate and will follow up, as appropriate.  With regard to borates, the US delegate pointed out 
that the results of the various risk and impact assessments commissioned by the European 
Communities validated the concerns that the Unite d States and other WTO Members had been raising  G/TBT/M/49  
 Page 25 
 
 
  about the impact of the DSD/CLP classification under other EC legislation, if the EC does not 
examine intended end uses under such legislation.  In particular, the borates assessment demonstrated 
that there was no appreciable risk of exposure from using the borate-containing products analyzed.  It 
was the US understanding that this was the first case where the European Communities had 
commissioned such a risk and impact assessment an d did not automatically ban substances classified 
as "Category 2" under the Danger ous Substances Directive.  In this regard, the European 
Communities was invited to confirm that it would continue to examine av ailable scientific and 
technical information and intended end uses of s ubstances classified under the CLP regulation before 
subjecting them to restrictions under other EC legislation. 
110. Furthermore, the United States requested the Eu ropean Communities to provide clarification 
regarding the procedures for transferring the borat es and nickel classifications from the DSD to the 
CLP regulation.  In particular, the US delegati on stressed that industry was concerned that the 
European Commission automatically transferred classi fications under the DSD to the CLP, instead of 
following the new procedure for harmonized classi fication and labelling of substances specified under 
Articles 36 and 37 of the CLP regulation.  Coul d the EC delegation explain why the European 
Commission used the automatic transfer procedure set out in Article 53 of the CLP regulation rather 
than the procedures set out in Articles 36 and 37 ?  The United States noted that stakeholders 
continued to assert that the European Commission erred in its initial evaluation of borates and nickel compounds under both the 30
th and 31st ATPs to the DSD by not considering the normal handling and 
use of these substances, and  that this error could have been corrected by us ing the procedures set out 
in Articles 36 and 37 of the CLP regulation in the transferring of classifications between the two 
measures.  He also urged the European Communities to clarify the impact of its borates classification 
on cosmetics since that product was not covered by the EC risk and impact assessments.  Could the 
European Communities clarify whether borates were ba nned for use in cosmetics or were they still 
subject to the threshold for boric acid under the Cosmetics Directive?  The US delegation would 
continue to monitor the potential adverse trade impa cts of the nickel and borates classifications and 
the potential methodological issues raised. 
111. The representative of the Dominican Republic  shared the concerns expressed by other 
Members about the reclassification of nickel carbonates and other nickel compounds under the 30th 
and 31st ATPs to the DSD and the transposition of  the results of these ATPs into the 1st ATP to the 
CLP regulation, which her delegation considered to lack sufficient scien tific evidence.  She also noted 
that the many comments expressed by various dele gations at the TBT Committee meetings held in 
2008 and 2009 had not been taken into account by the European Communities.  The representative of 
the Dominican Republic recalled that written comments regarding the 31st ATP had been sent to the 
EC delegation on 18 November 2008, and were sub sequently circulated to all WTO Members in 
document G/TBT/W/302.  She regretted that her delegation had not received any response from the 
European Communities.  She was also disappoint ed that the Technical Progress Committee (TPC) 
approved the 31st ATP on 19 November 2008, within only 24 hours of the end of the notification 
comment period.  It was her delegation's view that, having been adopted in these circumstances, the 31
st ATP did not satisfy the requirements set by Article 2.9 of the TBT Agreement.  
112. Furthermore, the Dominican Republic objected  to the manner in which the European 
Communities applied the read-across methodology in the reclassification of nickel  substances.  In this 
regard, the representative of Dominican Republic be lieved that the European Communities violated 
Article 2.2 of the TBT Agreement which stipulated  that "Members shall ensure that technical 
regulations are not prepared, adopted or applied w ith a view to or with the effect of creating 
unnecessary obstacles to international trade".  She reca lled that nickel exports represented, in 2007, 
more than 50 per cent of the total exports of the Dominican Republic, with a total value of USD1,153 
million, and that the 31st ATP would have serious harmful effects for both producers and exporters of 
nickel substances.  Moreover, she stressed that the EC measure would have a devastating effect on the 
industry and economy of the country as a whole, also considering the serious drop in nickel prices that G/TBT/M/49  
Page 26  
 
  occurred in 2008, which had reduced the total valu e of Dominican Republic's nickel exports to 
USD492 million.  As a further example, it was point ed out that a nickel company in the Dominican 
Republic had been obliged to dismiss more than  nine hundred workers in November 2008 and was 
currently out of business.   
113. The implementation of the 1
st ATP to the CLP regulation was likely to further aggravate 
conditions in a very economically depressed area of the Dominican Republic, where the population's 
income relied only on nickel extractions, as well as causing increased production, transport and 
insurance costs and worsening conditions in a in dustry already severely affected by the world 
economic crisis.  The European Communities was therefore encouraged to comply with the 
obligations set by Article 2.9 of the TBT Agreement, and to notify the draft 1st ATP at an early 
appropriate stage, allowing reasonable time for Members to comment. 
114. The representative of China  shared the concerns raised by  previous speakers and expressed 
disappointment at the adoption of the 1st ATP of the CLP Regulation.  His delegation stressed that the 
classification of nickel compounds was not based on sound scientific information and reiterated 
China's concerns about the incorrect use of the read-across methodology by the European 
Communities and the lack of transparency when transferring the 30th and 31st ATP of the DSD 
Directive to the CLP Regulation .  China also noted that in statements provided at previous 
meetings of the TBT Committee, the European Communities had assured the Committee that the new 
classification of nickel compounds only related to labe lling and would not result in bans or restrictions 
on the use of chemical substances in consumer pr oducts.  However, the European Communities had 
recently proposed a new toy regulation that restrict ed the use of a number of nickel substances.  
Finally, China noted that the European Comm unities intended to ban th e sale of carcinogenic, 
mutagenic and reprotoxic (CMR) s ubstances Category 1A and 1B, a nd urged the EC delegation to 
clarify what the downstream consequences of this new classification would be. 
115. The representative of Australia  remained concerned that the EC’s decision to reclassify nickel 
compounds under the 31st ATP was based on questionable scientif ic and procedural grounds and it 
had been adopted while the concerns of WTO Me mbers remained outstanding.  She recognized the 
importance of ensuring a high standard of protection for human health and safety and for the environment and supported the deve lopment of regulatory strategies to insure such protection.  
However, Australia noted that, in accordance with  Article 2.2 of the TBT Agreement, the EC’s 
regulatory regime for nickel should not create unn ecessary obstacles to international trade.  The 
representative of Australia also recalled that th e Australian assessment authority, the National 
Industrial Chemical Notification and Assessment Sc heme (NICNAS), had reviewed the scientific 
literature available on the issue in late 2008, including EC and OECD documentation, and had 
concluded that:  (i) there was no reliable data on th e carcinogenic potential of nickel carbonates;  (ii) 
the use of read-across methodology should be base d on groupings of substan ces which were robust 
and scientifically valid; and (iii) solubility in wa ter alone was an insufficient criterion on which to 
base the read-across methodology. 
116. Furthermore, despite assurances by the Europ ean Communities that th e only impact on 
industry from the reclassification of nickel would be a requirement to label products differently, there 
was some evidence of stigmatization of nickel resu lting from the reclassification of various nickel 
compounds.  For example, it was Australia's understa nding that:  (i) the proposed EC Green Public 
Procurement Criteria would exclude the use of stainless steel containing more that one per cent nickel 
in air conditioners and heat pumps;  (ii) unde r the revised EU Eco-Label Directive products 
incorporating alloy steels and stainless steel containing one per cent or more nickel were not eligible for an EU Eco-label;  (iii) EC mobile phone produ cers were looking to suspend the use of nickel in 
anti-radiation barriers;  (iv) the 2012 London Olympic Games Sustainable Sourcing Code listed 
nickel, in relation to battery applications, as a mate rial to be avoided.  Finally, Australia expressed 
concern about the recent comments by DG Environmen t, at the October International Nickel Study  G/TBT/M/49  
 Page 27 
 
 
  Group Meeting, that the prevailing EC view on the reclassified nickel compounds was that nickel 
compounds should be substituted.    
117. The representative of Indonesia  joined other delegations in  expressing concern about the 
classification of nickel substances in the 30th and 31st ATP and their incorporation in the 1st ATP to 
the CLP regulation.  Indonesia was particularly concerned about the absence of data for the 
classification of nickel carbonate, the flawed applic ation of the OECD read-across methodology, the 
absence of justification for skipping some important read-across steps, the lack of water solubility 
data for reclassified nickel compounds despite it  being the only step used by the European 
Communities, and the fact that the European Commission had failed to demonstrate that the 
classification decisions were based on any data at a ll.  Concerns remained also on the lack of 
consultation with WTO Members on the draft 1st ATP to the CLP regulation on the grounds that 
consultation had already occurred on 30th and 31stATPs.  In this regard, the representative of 
Indonesia stressed that the CLP regulation was a different regulatory framework.  The European 
Communities was invited to revise its regulation to ensure that it would not constitute an unnecessary 
barrier to trade. 
118. The representative of Turkey  continued to have serious concerns about the 30th and 31st ATPs 
and the transposition of the results of these ATPs into the 1st ATP of the regulation on Classification, 
Labelling and Packaging of substances and mixtures (CLP) .  She recalled that at previous meetings of 
the Committee the European Communities had declared  that the classification of borates would have 
no impact for the European market in terms of pr oduction and import of substa nces and preparations 
containing borates.  This statement had also been c onfirmed on a bilateral basis.   The Turkish delegate 
also noted that on 10 August 2009 the REACH regula tion had been amended to reflect the changes 
made by the 30th and 31st ATPs to the DSD (G/TBT/N/EEC/297).  She pointed out that this regulation 
amended Annex VI of the CLP regulation, which classified the borates as reprotoxic substances and 
required warning labels containing standard sym bols and phrases to be placed on the substances' 
packaging.  However, it was Turkey's understandi ng that the above-mentioned legislation did not 
relate only to classification and labe lling requirements.  In this regard , the delegate of Turkey noted 
that substances classified as Category 1 or 2 under the DSD, or Category 1A or 1B under the CLP 
regulation, would be prioritized and be subject to  authorization under REACH.  With regard to the 
new requirements notified by the EC (G/TBT/N /EEC/297), it was Turkey's understanding that, 
despite the fact that borates and derivatives were listed in REACH Annex XVII, in detergents and in 
photographic applications, there would not be any re strictions as they did not contain borates above 
concentration limits. 
119.  In addition, the representative of Turkey noted  that the so-called "Substitute It Now" (SIN) 
list, which had been developed by a non-govern mental organization called ChemSec (International 
Chemical Secretariat) to speed up inclusion of  dangerous substances into the SVHC list under 
REACH, had been updated on 13  October 2009.  She stressed that 89 new substances that were 
classified as carcinogenic, mutagenic or reprotoxic (CMRs) in the CLP Regulation, including boric 
acid and derivatives, had been added to the SIN Li st.  Although the SIN list had been created by a 
non-governmental organization and was not legally binding, some companies had begun to integrate it 
into business decisions concerning purchasing a nd manufacturing in order to address growing 
consumer safety demands.  Therefore, it was Turkey's view that the classification of borates as toxic to reproduction and their following inclusion to the SIN list would impose a negative effect on borates 
sale.  Finally, the representative of Turkey sought further clarification on the plans of the European 
Commission, ECHA or EC member States about borates and their classification and invited the European Communities to reconsider its classification decision. 
120. The representative of Korea
 shared the concerns raised by previous speakers and recalled that 
the ACP group had submitted comments in wr iting at the March 2009 Committee meeting 
(G/TBT/W/307).  Korea was particularly concerne d that the European Communities had not proved G/TBT/M/49  
Page 28  
 
  the nickel classification was based on a sound and tran sparent scientific method.  In particular, the 
European Communities' reliance on water solubility as the initial and primary basis for categorizing 
nickel compounds was not supported by scientific facts.  The Korean industry was also concerned about costs of registration and data production in the implementation of the CLP regulation. 
121. The representative of the European Communities
 noted that several concerns raised, such as 
read-across methodology and water solubility, were reiterations of concerns previously expressed and 
to which her delegation had already adequately replied.  On the question raised by Japan about the 
labelling of certain substances with the term "explo sive", the EC representative explained that the 
requirement to classify and label substances in accordance with the CLP regulation would apply from 
1 December 2010.  With regard to mixtures, the transitional period would extend until 1 June 2015.  
However, if a supplier voluntarily chose to appl y the CLP provisions on classification before the 
December 2010 deadline, they had to apply the labelling and packaging provisions of the CLP 
regulation and not those of the DSD regulation.  This  rationale also applied to the term "explosives": 
substances have to be classified and labelled until 30 November 2010 as “explosive” in accordance 
with the DSD. Voluntarily the CLP provisions for e xplosive substances or mi xture could be applied 
before these dates, but in that case the label had to respect the CLP criteria. 
122. On the comments about the notification oblig ations, the representative of the European 
Communities explained that Articles 39 and 40 of  the CLP regulation required manufacturers and 
importers to notify substances subject to regist ration as well as substances meeting the criteria for 
classification as hazardous, on their own or in mixtures  above certain concentration limits.  She noted 
that this requirement already applied in REACH and was transferred to the CLP regulation with effect 
from January 2009.  She further noted that the notif ication obligation applied when such substances 
were placed on the EC market.  It was recalled that  Article 40.1 (2) of the CLP Regulation exempted 
information from being notified to the classification and labelling inventory if they had already been 
submitted to the European Chemicals Agency (EC HA) as part of the mandatory registration under 
REACH.  While substances not classified as hazardous  were not subject to notification requirements, 
substances classified as hazardous only had to be notified when present in mixtures above certain 
concentration limits.  However, there was no require ment to notify confidential business information, 
such as details on the full composition of a mixture or on the precise use of substances.  In this regard, 
the representative of the Europ ean Communities informed the Co mmittee that ECHA was currently 
developing the tools to be used for notifying  substances under the CLP regulation.  ECHA was 
particularly interested in developing a notification process that was clear and simple, especially in the 
cases of groups of manufacturers or importers a nd in the cases when the substance had already been 
notified by another user. 
123. The European Communities stressed that the cl assification of a substance or preparation as 
carcinogenic, mutagenic and reprotoxic (CMR) did not  entail an obligation to phase out the use of 
these substances, but only to provide informatio n on their hazardous properties.  She further 
emphasized that manufacturers self-declared informa tion about the substance on the label and that 
there was no mandatory certification process which ha d to be followed before a product entered the 
EC market. 
124. On the restrictions applied under the EC dir ective on the marketing and use of dangerous 
substances, the European Communities confirme d that a proposed amendment to the REACH 
regulation (G/TBT/N/EEC/297) had been recently  notified to the TBT Committee.  This draft 
regulation prohibited the sale to the general pub lic – or the use in mixtures above a certain 
concentration limit - of a number of substances that  were classified as carcinogenic, mutagenic and 
reprotoxic (CMR) under the 30th and 31st ATP to the Dangerous Substance Directive.  It was stressed 
that only a few products which were sold in the EC  market contained borates beyond the limits set in 
the 30th ATP, notably detergents and photographic films.   Since a risk assessment carried out by the 
European Commission had shown that there was no ri sk of exposure to these products, exemptions to  G/TBT/M/49  
 Page 29 
 
 
  the restrictions had been granted.  On the imp act of the borates classification on cosmetics, the EC 
delegate pointed out that, according to the EC directive 2000/6, the use of borates in cosmetic 
products had already been restricted to certain co ncentration limits since February 2000.  This 
decision was based on the opinion provided by the Scientific Committee on Cosmetic Products after a 
risk assessment had been carried out.   
125. With regard to the nickel compounds classified  under the EC directive on marketing and use 
of dangerous substances and covered by the 31st ATP, it was the EC delegation's understanding that 
currently there were no products on the EC market that contained nickel, as a substance or preparation, beyond the allowed c oncentration limits.  In this regard, the European Communities 
stressed once again that the above-mentioned classifica tions and restrictions did not apply to articles, 
but only to preparations or substances.  There was currently no intention to impose any restrictions on 
articles containing nickel beyond those that already applied in a number of consumer goods, such as 
batteries or toys.  The EC representative also noted th at nickel in stainless steel was considered to be 
safe under the EC directive on toys.  She informed  the Committee that the comment period on the 
notified directive on marketing and use of danger ous substances was still open and invited Members 
who wished to provide comments to do so. 
126. With respect to comments made by Cuba on the incorrect classification of nickel substances, 
the EC representative recalled that nickel metal was classified as carcinogenic Category 3 in the 30
th 
and 31st ATPs, in line with the evaluation carried out  by the International Agency for Research on 
Cancer (IARC).  On the request to postpone the im plementation of the classification, she recalled that, 
as indicated in the adopted regulation, new argument s or scientific evidence submitted with regard to 
this classification would be examined by the European Communities.   
127. With respect to comments made by Australia  that there was no data on the carcinogenetic 
potential of nickel, the EC delegate referred to the conclusions of the meeting held by IARC in 
March 2009, which had endorsed the opinion of th e European Commission that nickel was a 
carcinogen.  Regarding comments made by several de legations on the stigmatization that the proposal 
could create on nickel, she stressed that several ni ckel compounds, including the most traded nickel 
compounds in the world, had been classified in th e European Communities for several years and that 
there had not been any negative impact on trade.  Regarding comments that certain industries had 
decided to phase out nickel or look for alternative s ubstances, she said that this decision was not under 
the responsibility of the European Commission.  Fi nally, with regard to the questions on how the 
substances classified were inserted in the REACH candi date list and subject to authorization, the EC 
representative referred to the explanations provided at previous TBT Committee meetings. 
(vii) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
128. The representative of the European Communities  reiterated her delega tion's concern regarding 
the Indian Order requiring a registration procedur e for imported cosmetics products.  She explained 
that the European Communities had followed-up on the invitation by India during the last Committee 
meeting to contact the Ministry of Health di rectly and that the European Communities had 
subsequently been informed that  a revised version of the legislation would be published in the 
autumn.  The EC delegate therefore asked India to  provide an update on the state of play and to 
inform the TBT Committee whether a revised version would be notified to the WTO. 
129. The representative of India  noted the concern raised by the EC delegation and assured the 
representative of the European Communities that in formation would be provi ded. Furthermore, she 
confirmed that no corresponding notif ication had been made so far.  
(viii) Israel – Infant Formula G/TBT/M/49  
Page 30  
 
  130. The representative of the United States
 reiterated concerns that Is rael had so far not published 
a draft infant formula regulation and notified it for comment to the WTO.  He recalled that importers 
needed clarity regarding the Israeli Ministry of H ealth requirements for infant formula so that trade 
was not disrupted.  He requested that Israel provide an update on the status and timing of the draft regulation as well as on the ongoing domestic litigati on regarding the infant formula regulation. 
131. The representative of Israel
 explained that the issue was curr ently being discussed in Israel. 
He said that Israel would inform the US representative about any new developments in a timely manner. He also informed the US delegate that a meeting among interested importers, exporters and 
high-level health authorities in Israel would be held  with the view to further discussing the matter and 
exploring ways to reach a satisfactory solution. 
(ix) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203 and Add.1) 
132. The representative of New Zealand
 reiterated her delegation' s on-going concern about 
Canada’s compositional cheese standards and the compliance of the latter with the principles of the TBT Agreement.  She stated that New Zealand' s assessment was that the standards were overly 
restrictive in nature; both in terms of the thresholds  imposed for the use of dairy ingredients as well as 
with respect to their impact on trade.  New Ze aland therefore requested Canada to provide the 
Committee with an update on the recent outcome of the court challenge on these cheese standards.  
Furthermore, the delegate from New Zealand ask ed Canada to comment on suggestions that it 
intended to introduce similar standards for yoghurt. Finally, the representative of New Zealand noted 
that the cumulative protective measures Canada ha d imposed on imported dairy products, including 
compositional standards for cheese, were inconsis tent with Canada’s G20 commitment not to 
introduce trade restrictive measures and urged Cana da to remove these measures as soon as possible. 
133. The representative of Australia
 shared New Zealand's concerns about the Canadian 
compositional requirements. 
134. The representative of th e European Communities  joined the other delegations in reiterating 
her delegation's concerns with respect to Canada ’s compositional standards for cheese. She also 
requested Canada to provide an update on the fede ral court challenge to these regulations and to 
confirm that these standards would not be exte nded to other dairy products, such as yoghurt. 
135. The representative of Switzerland  also expressed her concerns about the same issue. 
136. The representative of Canada  explained that when these regulations had been developed 
Canada took into account international standard s and other countries' regulations as well as the 
comments received during the notification period. Cana da therefore believed that the standards were 
in compliance with their WTO obligations.  With resp ect to the judicial review, the Canadian delegate 
informed the Committee that the hearing of the judicial review had been held on 31 March and 1 April 2009.  However, on 7 October 2009, the federa l court had dismissed the application for judicial 
review made by the applicant. She clarified that  the Government of Canada had not initiated any 
regulatory process for establishing compositiona l standards for other dairy products. 
(x) Brazil – Health products (G/TBT/N/BRA/328) 
137. The representative of Canada
 welcomed steps taken by Brazil to ensure that the new 
regulation by ANVISA9 was understood by its trading partne rs and their respective manufacturing 
facilities and that the regulation did not create an unn ecessary barrier to trade.  Canada had understood 
that, to date, Brazil had received 89 requests for in spection, and had arrang ed meetings with the 
                                                      
9 Agência Nacional da Vigilância Sanitária  G/TBT/M/49  
 Page 31 
 
 
  majority of these companies.  Canada requested Br azil to provide further data with regards to the 
exact number of certifications that ANVISA anticipated would be necessary.  
138. The delegate from Canada asked how the insp ection, certification and registration would 
work.  She also asked for clarification on whether companies which were not yet required to apply for 
certification because their registration had not expi red would still be in a position to participate in 
public bids, or whether these companies would be disqualified from bidding and what their 
relationship would be with companies that were already certified.   
139. Canada expressed concern that ANVISA might not be able to carry out all of the inspections 
necessary in the timeframe set out.  The Canadian dele gate therefore proposed that in the event that 
the required inspections were not carried out, Brazil should commit to granting exemptions to 
Canadian products already certified to internationa lly accepted Quality System Requirements (e.g. US 
Food and Drug Administration or Health Canada) and allow such exemptions to remain in place until 
Brazil had the capacity to inspect Canadian facilities.  
140. The Canadian representative welcomed Brazil's effo rts to  inform interested governments as 
well as to the private sector to explain in more detail how to fulfill the requirements of this new 
regulation.  Canada would also be interested in receiving in writing information pertaining to 
requirement of the inspections, the fees associated  with these inspections, how companies applied for 
these inspections, and whether a company would be  required to undergo an inspection each time it 
applied for the Good Manufacturing Practices (G MP) certificate from ANVISA.  The Canadian 
delegate also asked whether it was possible for a company to extend their GMP certificate by an 
additional year if the company had already been inspected and had no records of non-compliance 
registered.  
141. Finally, Canada emphasized that these concerns  were raised independe nt of good cooperative 
activities between Health Canada and ANVISA re garding the regulation of pharmaceuticals and 
medical devices.  In this respect, Canada appreciated the efforts Brazil had made to accommodate the concerns of trading partners. 
142. The representative of the European Communities
 echoed Canada's comments. She was 
grateful for Brazil's clarification provided at the last Committee meeting.  The European Communities 
understood from Brazil's answer that Brazil would stop accepting the ISO 13485 certification as evidence of compliance with GMP requirements and that Brazil intended to introduce new GMP 
requirements in this respect.  The European Co mmunities noted that these requirements seemed to 
diverge from the ISO standard 13485 which was the main international standard on quality 
management systems. Brazil had not given any justifi cation why this standard would be ineffective or 
inappropriate to be used as a basis for the new re quirements.  The EC delegate argued that in the 
absence of such a justification, the new requirement s had to be based on the relevant ISO standard as 
set out in Article 2.4 of the TBT Agreement. 
143. With respect to the certification procedure, the representative of th e European Communities 
stressed that note had been taken of Brazil's as surance at the last Committee meeting that ANVISA 
possessed the operational capacity to certify the compani es that requested to be certified.  In this 
context, the EC delegate also thanked Brazil fo r the important explanations given in a meeting 
between representatives of different Members and th e Brazilian authorities in Brasilia at the end of 
October and requested confirmation that only t hose producers whose current certification would 
expire before the 22 May 2010 would need to have the new certification by this date.  She further 
pointed out that the European Communities would closely observe the certification process, since 
industry had still expressed concerns that that there was a risk that this process would not be carried 
out in a timely manner, especially with regard to new products that needed to be certified.  Finally, the G/TBT/M/49  
Page 32  
 
  representative of the European Communities proposed to discuss with Brazil possible solutions for the 
recognition of certification carried out by EC notified bodies.  
144. The representative of Mexico
 supported the concerns expressed by Canada and the European 
Communities.  In addition, she requested that Br azil carry out a seminar on the topic for national 
experts from Mexico. 
145. The representative of Switzerland  asked to receive a written response to the concerns raised 
and in particular to those about the transitiona l period foreseen during which medical devices could 
still be exported to Brazil.  She said that Switzer land remained concerned about the question whether 
Brazil would continue to recognize quality inspecti on results based on the internationally recognized 
quality standard ISO 13485.  This reliance on inte rnationally recognized quality inspections would 
represent the same approach that the Swiss Govern ment currently followed and was also consistent 
with the approach recommended by the Global Ha rmonization Task Force.  If Brazil no longer 
accepted ISO 13485 certification as evidence of compliance with the Brazilian requirements, Switzerland urged Brazil to give the reasons for such a refusal. 
146. The representative of the United States
 recalled that at the June meeting of the TBT 
Committee the United States had outlined its concerns  regarding Brazil's inspection requirement for 
certain medical devices. His delegation noted that  productive meetings had occurred between the US 
Food and Drug Administration (FDA) and Brazil's ANVISA during the medical device information exchange forum in Brasilia in September, and that  the two agencies had agreed to further technical 
talks.  The United States welcomed the ANVISA in itiative to organize a meeting with local industry 
representatives and officials from various embassies to discuss industry's concerns and its offer to 
provide a technical note with replies to the ques tions raised by industry about the registration and 
inspection processes.  
147. The US delegate emphasized that Brazil had cl arified that class 1 and 2 devices would be 
exempted from the inspection requirement, that the inspections would only apply to the last place of 
manufacture and not to all the supplier facilities, and that only facilities that manufactured devices 
subject to re-registration or new registration would need to be inspected by 22 May 2010.  The United 
States also noted that ANVISA had been hiring additional inspectors and apparently had started 
scheduling inspections as well.  These were all ve ry positive developments, and the United States 
hoped that Brazil could confirm these points in writi ng.  However, the U.S. delegate conveyed serious 
concerns from US industry about ANVISA's ability and resources to conduct all the inspections by 
May 2010 as well as for subsequent inspections. Th e concern was that the implementation of this 
measure could substantially disrupt trade and je opardize the adequate supply of essential medical 
devices to the Brazilian market.  
148. The US delegate welcomed ANVISA's efforts to provide a technical note to clarify the 
application process. At the same time, he urged Br azil to clarify the number of facilities that were 
coming up for re-registration before the implementation date, and indicated that it would be helpful if 
ANVISA could share this information.  Finally, he  stressed the fact that the United States would 
monitor the situation closely and would work together  with Brazil to ensure that trade in safe and 
effective medical devices was not disrupted. 
149. The representative from Brazil
 offered some additional clarification to the TBT Committee on 
ANVISA Resolution number 25. He first noted that measures of the same nature were actually adopted by several other countries, and were jus tifiable as they pursued the legitimate objective of 
protecting human health. He recalled that the Cer tificate of GMP for medical devices that would be 
required from foreign companies exporting to Brazil was already required from domestic Brazilian 
producers and therefore would not constitute a di scrimination against foreign producers. He 
emphasized that the main objective of the Brazili an authorities was to ensure access to good quality  G/TBT/M/49  
 Page 33 
 
 
  medical devices for the Brazilian population. Co nsequently, the Brazilian Government had no 
intention of implementing Resolution 25 in such a way which would represent a restriction in the flow 
of medical devices into Brazil.  
150. Responding to concerns regarding the capacity  of Brazilian authorities to carry out the 
necessary inspections by May 2010, he underscored th at Brazilian authorities were fully prepared to 
deal with all the necessary inspections. He recalled that inspections were only necessary in order to 
renew registration or obtain a new registration fo r exporting medical devices. He further emphasized 
that inspections were due only in the plant of th e final manufacturer of medical devices pertaining to 
risk categories 3 or 4 that would export the product to Brazil; there was no need  for inspections in the 
plants of suppliers of pa rts of the devices. Regarding the inspec tions already required, he informed the 
Committee that 89 requests had been made, of whic h 50 were scheduled for 2009, 26 for 2010 and 13 
were in the process of scheduling.  He further noted  that there had, to date, been no difficulties for 
scheduling the inspections.  In addition, the Brazilia n delegate recalled that Brazilian authorities had 
hosted seminars and other bilateral events to help to provide further information on the measure and 
to help build reciprocal confidence among trading partners.  Brazil stood ready to maintain dialogue 
with all delegations in order to impr ove the understanding of Resolution 25. 
(xi) China – Proposed Regulations on Information Security (G/TBT/N/CHN/278-290) 
151. The representative from Japan  recalled that, following the announcement on 29 April 2009 by 
relevant Chinese authorities to apply the compulsory certification scheme of IT security products only 
for government procurement, China had expressed its understanding that this issue was no longer 
subject to the TBT Agreement. However, in Japan's  view the scope of government procurement in 
China was not defined clearly enough and thus the regulation nevertheless needed to be addressed in 
the TBT Committee. 
152. He expressed two major concerns that arose fro m the scheme. First, Japan asked for more 
clarity regarding the coverage of the scheme such  as areas and the types of products, including the 
scope of government procurement. In this context he asked for clarification on whether State Owned 
Enterprises were not subject to this scheme. Sec ond, the representative of Japan expressed concerns 
that the standards of the current scheme differed from international norms concerning the certification 
of IT security products. In this context, the repr esentative of Japan supported the request made by the 
European Communities in the previous TBT Comm ittee meeting to clarify why the Chinese scheme 
provided a broader coverage for mandatory certifi cation requirements than international practice 
where specific requirements only existed in relati on to national security critical infrastructure. 
153. The representative of the European Communities  reiterated the concerns expressed by the 
delegation of Japan with respect to the thirt een proposed implementing rules for compulsory 
certification of various information technology products.  He reminded the Committee of past 
arguments expressed by the EC dele gation regarding incons istency with international practice and the 
overly extensive information requirements for applican t companies. He requested further clarification 
from China as to whether state-owned enterprises w ould be excluded from the notion of government 
procurement. Furthermore, the EC delegate asked China to provide additional information on whether 
foreign companies investing or established in China would be able to apply for the China Compulsory 
Certificate (CCC).  He also asked about the curre nt status of implementation of these rules which 
were due to enter into force on 1 May 2010.  
154. The EC delegate urged China to provide a ge neral update on the revision of the implementing 
measures that had been notified and on the speci fic information security mark currently being 
developed by the China Information Security Certifi cation Centre. He also invited China to notify the 
final implementing measures under the relevant WTO transparency requirements.  G/TBT/M/49  
Page 34  
 
  155. The representative of the Europ ean Communities thanked the Certification and Accreditation 
Administration of the People's Republic of China (CNCA) and other Chinese governmental agencies for keeping an open channel of communications w ith the European Communities and for offering to 
meet to clarify some questions.  However, he had serious concerns that the CCC was part of a more complex regulatory framework in the field of info rmation security which involved rules developed by 
various ministries and public agencies. The combined effect of all these measures could be one of 
severely limiting market access opportunities in China for information security products made by non-
Chinese companies, i.e. foreign co mpanies or foreign invested co mpanies legally established in 
China.  
156. First, the representative of the European Comm unities noted that following the administrative 
measures for the multilevel protection scheme (MLPS) a dopted by the Ministry of Public Security on 
22 June 2007, all IT systems in China had to be classi fied into different levels of security on a scale of 
1 to 5 according to the importance of the information handled by the system and its perceived value to 
national security. Systems classified at level 3 or above were considered as  critical infrastructure 
triggering specific obligations on the IT system managers regarding what  products, systems, and 
information security management technologies should be used to handle the information.  It was the 
understanding of the European Communities that cr itical infrastructure included banks, insurances, 
transportation, as well as all public utility sectors. In practice, IT systems operated by the government or government-related bodies as well as by state owne d enterprises were all considered as critical 
infrastructure. While many governments had taken sim ilar approaches to classify the level of security 
needed for sensitive military and government agenci es, the European Communities was concerned by 
the fact that China had extended this regulatory fra mework to cover all IT systems of non-government 
state owned enterprises.  
157. The European Communities was of the opinion th at China’s interpretation of the notion of 
national security under the MLPS appeared to be mu ch wider than that of any other country, and 
posed a heavy burden on economic operators. The representative of the European Communities 
considered the consequences of an IT system bei ng classified as critical infrastructure. Managers of 
any such system would only be allowed to use products meeting the following requirements: (i) 
intellectual property rights of core information technology and key components had to be Chinese; 
(ii) the product developers and manufacturers had to  be invested or owned by Chinese citizens, legal 
persons or the state; (iii) products whose core f unction was encryption had to have been approved by 
the Office of State Commercial Cryptography Administration (OSCCA) pursuant to the 1999 
Regulation of Commercial Encryption Codes; (iv) products within CNCA’s product catalogue, when 
procured by a system operator, had to have co rresponding product and system level classification and 
have been certified by the China Inform ation Security Certification Centre. 
158. Second, it was the European Communities' understanding that the 1999 OSCCA Regulation 
on commercial encryption prescribed that the pr oduction, distribution and sale of information 
technology products whose core function was encryption was reserved for approved Chinese 
companies. Hence, foreign manufacturers were cu rrently unable to export encryption products to 
China for commercial purposes under the terms of the regulation. By the same token, foreign owned 
companies established in China were equally de nied access to the OSCCA business licence and the 
product certification needed to sell commercial encryp tion products. The EC delegate argued that the 
effect of these restrictions was that a foreign comp any or a foreign invested  company in China had no 
legal possibility to place products whose core function was encryption on the Chinese market, 
irrespective of the end customer.    
159. The EC delegate requested China to clarify th e rationale for this system which effectively 
denied market access to foreign products or even  products made by foreign invested companies 
established in China, in areas which were clearly considered as commercial areas according to global 
practices.  The European Communities further urged China to promptly revise the OSCCA  G/TBT/M/49  
 Page 35 
 
 
  regulations in order to ensure equal market  access opportunities between domestic and foreign 
companies / foreign invested comp anies in China, based on technical regulations and conformity 
assessment procedures aligned with international practice.  
160. The European Communities invited China to con tinue having an exchange of experiences on 
current global practices for trade in  information security products.  
161. The representative of Korea  welcomed China's decision to postpone the implementation of 
the regulation and to reduce the scope of the origin al regulation. However, he expressed the concern 
of many Korean exporters of IT security products  on the burden of compulsory certification and the 
lack of information on this regulation. The Korean  delegate asked China to  provide more detailed 
information to all WTO Members regardi ng the implementation of this regulation.  
162. The representative of China  recalled that the regulations at issue had been notified to the 
WTO in 2007.  Since then, comments from so me Members had been received and regular 
communication was maintained through bilateral disc ussions and other activities.  Taking into account 
the requests from Members, the regulation had been revised and adopted in April 2009 postponing the 
actual implementation of the relevant measures by almost two years.   He recalled that China had 
informed the Committee during the last meeting in J une that the final regulation fully incorporated 
comments made by relevant stakeholders, both dom estically and abroad, and had been significantly 
adjusted in terms of the applicable scope, par ticularly by limiting the measures to government 
procurement. The Chinese delegate was therefore of the view that the TBT Committee was no longer 
the appropriate forum for discussing the regulation.  He also clarified that the certification requirements of the new regulation within the scope of government procurement was neither 
mandatory for commercial sectors nor subject to  the CCC scheme as had been argued by the 
European Communities. With resp ect to Japan's concerns regarding the scope of government 
procurement, he suggested discussing the issue in another forum. 
(xii) China – Wines (G/TBT/N/CHN/197) 
163. The representative of th e European Communities
 reiterated her delegation's serious concerns 
regarding overly strict Chinese specifications related to maximum levels of sulphur dioxide in wines.  
She recalled that the European Communities had re peatedly raised this issue at TBT Committee 
meetings, highlighting the difficulties of several EC  member States in accessing the Chinese market.  
In particular, concern had been expressed about Ch ina's lack of consideration of international 
standards such as the Codex standard on food a dditives, which set the maximum allowed level of 
sulphur dioxide in sweet wines at 400 milligrams pe r litre.  The EC representative noted that at the 
Committee's previous meeting China had indicated th at the more restrictive sulphur dioxide limits 
contained in the Chinese standard on food additives were justified by Chinese consumers’ drinking 
habits, which were different than those of other c onsumers worldwide.  In this regard, the Chinese 
delegation was invited to provide the scientific da ta used to justify the assessment that the above-
mentioned international standard was not an ade quate means for achieving China's objectives.  China 
was also encouraged to confirm that, following an  application filed by a Chinese manufacturer, the 
standard was being reviewed.  The EC delegation urge d China to review the limits of sulphur dioxide 
content in wines sold on the Ch inese market, in order to align them with existing international 
standards.  
164. The representative of China  noted that an explanation had been provided at previous meetings 
of the TBT Committee.  He recalled that the Chinese regulation aimed at reducing risks of 
contamination caused by food additives; it took th e approach of reviewing applications for new 
additives and increased amounts of additives. He also  stressed that other WTO Members, including 
the European Communities, had in place regulations of food additives based on the same approach. It 
was the Chinese delegation's view that its regula tion was consistent with WTO provisions and the G/TBT/M/49  
Page 36  
 
  limit of sulphur dioxide in wine was based on so und scientific evidence, taking Chinese drinking 
habits into consideration.  Furthermore, the re presentative of China recalled that he had reminded 
European Communities of the regulation and had invite d EC wine producers to make an application to 
the Chinese Ministry of Health for review.  To date , no such applications had been received from EC 
producers.  However, the representative of China confirmed that a Chinese company had recently 
filed an application to increase the allowed content of  sulphur dioxide in wine.  This application was 
currently under public review and the European Co mmunities was encouraged to participate in the 
comment process.  China noted that  more information on this pr ocess was available on the Chinese 
Ministry of Health website.
10 
(xiii) Brazil –Toys (G/TBT/N/BRA/259; 313 and 339 and Add.1)  
165. The representative of Thailand  recalled that Brazil's proposed INMETRO Decree for toy 
testing and certification had been notified to the TBT Committee in doc ument G/TBT/N/BRA/339 on 
24 July 2009.  A reply to Thai comments was s till pending.  It was Thailand's understanding that 
Brazil had revised its seal affixation requirement, bu t, unfortunately, not for the better. A new body 
called "Product Certification Agency" (PCA) had b een introduced with new responsibilities for:  
issuing the compliance identification seal; ensu ring that the quantity of seals requested was 
compatible with the production capacity of the certification holder; and asking INMETRO to grant 
numbers in sequential order for the seal.   Also certified businesses or individuals were required to 
"keep records and sequential control over the numbe ring on the seals granted that are used or in 
stock." This appeared to be complex. Tha iland questioned whether the new provisions on seal 
affixation had anything to do with ensuring toy quality or safety.  They appeared to add in procedural 
complexity, escalating administrative burdens and dela ying costs for importers.   In Thailand's view, 
the measure was more strict than necessary to give  Brazil adequate confidence that toys conformed 
with Brazil's technical regulations on toy safety; as such the measure would create an "unnecessary obstacles to international trade" within the m eaning of Article 5.1.2 of the TBT Agreement. 
Moreover, the measure appeared to be inconsistent with Brazil's obligations under Article 5.2.1 of the 
TBT Agreement to ensure that conformity assessme nt procedures were undertaken and completed as 
expeditiously as possible.  
166. The representative of Thailand noted that tr ansitional provisions of the proposed decree 
discriminated against imports because they effectively granted a one-year grace period for domestically manufactured toys, while requiring immediate compliance by importers. This was 
inconsistent with Brazil's national treatment obliga tion under Article 5.1.1. In fact, the imposition of 
the requirement of immediate compliance on imports meant that imported toys had access to the 
Brazilian market under "less favourable" conditions than domestic toys.   
167. The representative of Thailand also noted that Brazil required reports on tests performed 
abroad to have a "sworn translati on into Portuguese (Brazil)."  In Th ailand's view this would lead to 
increased delays and costs for imported goods and was more strict than necessa ry within the meaning 
of Article 5.1.2.  A reasonable alternative would be for INMETRO to accept conformity assessment 
reports in English, as did many importing countries around the world. 
168. Also, in the view of Thailand, the proposed d ecree appeared to provide excessive penalties for 
non-compliance.  It stated that if the non-comp liant product had been evaluated in accordance with 
System 5 "the licensed business will be suspended fo r a period of four months from the time of the 
last removal of the non compliant products".  It wa s not proportionate that one failed product test be 
the basis for the "licensed business" itself to be suspended. Such a provision was more strict than is 
necessary within the meaning of Article 5.1.2 
                                                     
 
10 http://www.moh.gov.cn/publicfiles// business/htmlfiles/wsb/index.htm .  G/TBT/M/49  
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  169. With respect to the WTO notification, it w as noted that Brazil had notified the proposed 
decree under Article 5.7.1 of the TBT Agreement,  which allowed for the omission of the steps 
enumerated in Art. 5.6 "where urgent problems of safety, health, environmen tal protection or national 
security arise or threaten to arise for a member ". In such urgent cases, Art. 5.7.1 provided that the 
Member adopting the measure was required to "notify immediately other Members through the 
Secretariat of the particular procedure, including  the nature of the urgent problems". However, 
Brazil's notification sought to justify its derogation from the notification requirements in Article 5.6 
with a single brief reference in Section 7 of its notif ication on the "Protection of human health". This 
fell short of the standards set out in Art. 5.7.1.  Thailand strongly urged Brazil to revise the proposed decree so as to bring Brazil's toy testing and certif ication requirements into conformity with Brazil's 
obligations under the TBT Agreement. 
170. The representative of China
 echoed the concerns expressed by  Thailand and noted that written 
comments had been sent to Brazil on 7 August 2009 and a formal reply had only been received shortly before the Committee meeting; it was currently  being considered.  On a preliminary basis, the 
representative of China said that, in its reply, Br azil had mentioned that some changes had been 
introduced to the draft regulation taking into ac count Members' comments, and that the final 
regulation, adopted on 29 October 2009, woul d soon be notified to the WTO. While China 
appreciated the progress made, her delegation still shared some of the concerns expressed by Thailand, especially on the discriminatory treatment against imported toys in terms of the transitional 
provisions.  He invited Brazil to confirm that the "C ompliance Identification Seal" could be affixed in 
exporting countries as indicated in the bilateral talk s so as not to be more trade restrictive than 
necessary. 
171. The representative of the European Communities
 noted that, according to his understanding, 
the final decree had been issued and published on 29 October 2009 as Ministerial Act (PORTARIA) 
No. 321.  The European Communities had therefore not yet carried out a detailed assessment of the 
final text.  The EC representative asked for confir mation that, pursuant to the final decree: importers 
would be free to choose between the System 5 and System 7 procedures; that there would be no seal 
requirements based on sequential numbers; and that th ere would be more reasonable penalties in case 
of non-conformity, linking the suspension of the valid ity of certificate to the period necessary to bring 
the product into compliance.  With respect to the System 5 procedure in particular, the European 
Communities asked for confirmation that: it would be  possible to affix the seal in the country of 
export; that tests carried out by ILAC-accredited foreign laboratories would be accepted and therefore 
there would be no requirement for duplicative in-country testing; and that companies holding ISO 
9001:2008 certificates would be exempted from the factory audit on their quality assurance system.  
172. The European Communities understood that the fi nal version of the decree established a so-
called "system certification authority" (the acron ym in Portuguese being OCS) which had to be 
accredited by INMETRO. The European Communiti es asked for confirmation that INMETRO would 
accept accreditation certificates of inspection bodies issued by IAF members meaning that foreign 
inspection bodies would be able to perform the necessary factory audits.  In other words, the 
European Communities was looking for confirmation th at foreign inspection bodies would be able to 
be accredited by INMETRO for the purposes of a qua lity assurance system and that if they held 
international accreditation certificates, this would mean that accreditation by INMETRO would be quite smooth. The representative of the European Communities said that if these understandings were 
confirmed, the amendments to the initial dr aft INMETRO decree were indeed welcome 
improvements, which, based on an initial assessment, would appear to effectively address most of the 
concerns raised by the European toy industry. 
173. With respect to the requirement for importers to supply a "sworn tran slation" into Portuguese 
of foreign test reports and of any other relevant documents that should be submitted for the purpose of 
the System 5 procedure, while the representative of the European Communities fully understood the G/TBT/M/49  
Page 38  
 
  need to provide the translation, he asked if a lo cal sworn translation was always necessary and noted 
that, perhaps, considering the context, this mi ght be considered an excessive requirement.  The 
representative of the European Co mmunities encouraged Brazil to c onsider whether some flexibility 
could be introduced as to how this translation c ould be provided.  For instance, the European 
Communities asked whether this translation could be made by a sworn translator in the country of 
export or whether the Brazilian authorities could al low the importer to provide a self-guaranteed 
translation, coupled with the possibility of a pena lty for non-conformity of the translation with the 
original documents.  The representative of the Eu ropean Communities finally thanked Brazil for the 
transparency and regard for trade partners’ con cerns that had been shown by INMETRO in the 
revision of the decree. 
174. The representative of the United States
 welcomed the announcement that Brazil would 
eliminate the requirement that imported toys underg o a second set of testing in Brazil. Furthermore, 
the United States welcomed Brazil's decision to allow imported toys to be marketed in Brazil based on 
testing performed by any laboratory that had been accredited by a ILAC MRA signatory, at least in 
some circumstances; to give foreign producers the option to import under Systems 5 or 7; and to 
provide a transition period for producers to comply  with the new regulation.  The United States 
thanked INMETRO for having incorporated these elem ents in the final regulation and having, in the 
US understanding, published it the day before the current TBT Committee meeting.  The regulation 
would be reviewed and the United States would reve rt to Brazil with any remaining concerns. With 
respect to cases where INMETR O did the accrediting, the United States welcomed receiving 
additional information from Brazil to clarify the accr editation criteria and application process for test 
laboratories.  The United States noted that it looked  forward to continuing to work together with 
regulators from Brazil and other countries on devisi ng appropriate measures to ensure that children 
are protected from potentially unsafe toys. 
175. The representative of Brazil  stressed that the measures adopt ed by the Brazilian Government 
regarding the toy sector had been designed to ensu re safety through the enhancement of conformity 
assessment procedures that were applied to prod ucts whether imported or domestically produced. 
These measures acquired a special importance since th e products – toys – where were destined for 
children.  The representative of Brazil informed the Committee that the regulation had been published 
on 3 November 2009 in the Ministerial Act No. 321, dated 29 October 2009, replacing Ministerial 
Acts No. 326 and 376 of 2007.  Ministerial Act No. 321 had some new dispositions concerning the 
conformity assessment procedures applicable to toys aiming at the simplification of those procedures 
without jeopardizing safety.  He stressed that it granted equal treatment to both domestic and foreign 
producers.  Ministerial Act No. 321 was drafted ta king into account comments made by the public in 
general and by other Members thr ough public consultations which had be held since November 2008.  
The Act had been notified the previous day to th e WTO.  Brazilian authorities were confident that, 
after almost a year of work on this matter, the conformity assessment procedures laid down in 
Ministerial Act No. 321 were the most adequate to ensure the safety of children and were in 
accordance with the Brazilian obligati ons under the TBT Agreement.    
176. In response to specific questions, the representa tive of Brazil noted that his delegation had 
recently sent a reply to the Thai focal point on co mments received.  With r espect to the need for 
sequential numbers in the seals, the Act did not requi re the presence of this sequential number, and the 
seals could be affixed to toys in the territory of the exporting Members.  Moreover, the exporter could 
choose between Systems 7 or 5 if it complied with the requirements of those certification systems. 
(xiv) United States – Consumer Product Safety Improvement Act (G/TBT/N/USA/421)  
177. The representative of China  reiterated his delegation’s con cerns about the US Consumer 
Product Safety Improvement Act (CPSIA).  He reca lled that at previous meetings of the TBT 
Committee, China had expressed serious concerns in cluding with respect to the non-transparency of  G/TBT/M/49  
 Page 39 
 
 
  the Act and the unnecessarily stringent requireme nts on lead limits. China’s key concern was the 
different treatment by the US Consumer Produc ts Safety Committee (CPSC) against Chinese 
governmental laboratories.  It was recalled that th e United States had stated that China's relevant 
governmental laboratories were not recognized becau se they failed to meet the requirements of the 
CPSIA.  The representative of China said that the re ason his governmental laboratories failed to meet 
the criteria, as determined by CPSC, was not because  they were not technically competent, but rather 
because the criteria set for them in the CPSIA were more stringent than those required for third party 
laboratories.  In fact, the non-profit governmental la boratories of China were legally responsible for 
the testing of export products to ensure their comp liance with foreign requireme nts; they were free of 
undue influence from commercial interest, and, i ndeed, were more impartial than third party 
laboratories. Therefore, China invited the United St ates to once again consider its concern and apply 
the same recognition criteria to China's government al laboratories as those applied to third party 
laboratories.  In addition, China had received se veral complaints from its industry regarding the 
approval procedure for "All Terrain Vehicles" by CPSC under its "Safety Action Plan" within the 
scope of CPSIA. According to these complaints, the approval procedure was extremely time 
consuming and lacked transparency. China appreci ated the US willingness to pass this concern to 
competent authorities and so as to explore ways of addressing it. 
178. The representative of the United States  noted that there had been twelve CPSC measures 
notified to the WTO and that four of those – with the numbers: 484, 486, 489, and 490 – had been made since the last meeting of the TBT Committee.  These measures and proposed measures covered all aspects of CPSC implementation of the statute.  He directed China and other Members to the 
CPSC website,
11 which provided key guidance documents on test procedures, test methods, and 
accreditation, a list of accredited laboratories, ge neral counsel advisory opinions, and specific 
guidance for small businesses.  There was also a sect ion of the website that provided information in 
Chinese. 
179. On the issue of government laboratories, the re presentative of the United States noted that 47 
laboratories based in China had been recognized by  CPSC.  It was hence not accurate to say that 
CPSC had not accepted any Chinese Government labor atories; in fact, CPSC had approved nine 
Chinese Government joint-venture laboratories.  China’s CIQ laboratories had not been accepted 
because they did not meet the relevant conditions.  The United States remain ed puzzled that China 
continued to raise the laboratory accreditation issu e in the WTO TBT Committee.  The United States 
had opted for a highly trade facilitative approach in its testing regime for children’s articles, one that 
was based on relevant international standards a nd acceptance of test results from laboratories – 
wherever they would be located – and that had been accredited by ILAC MRA signatories.  Under 
this approach, CPSC had already accredited 47 labora tories based in China.  In view of the United 
States, the CPSC’s approach was a model for other countries – including China – that required third party testing for certain regulatory schemes.  Given US recognition of several laboratories located in 
China, the United States asked when  China itself would be recognizing test results from laboratories 
in the United States that had been accredited by ILAC MRA signatories, with respect to the CCC 
system and other Chinese regulatory schemes. 
(xv) European Communities – Produc tion and Labelling of Organic Products (G/TBT/N/EEC/101 
and Add.1) 
180. The representative of Argentina
 reiterated his country's concerns  pertaining to the EC Council 
Regulation No. 834/2007 regarding the labellin g of organic products, notified in document 
G/TBT/N/EEC/101. Argentina's concern was that Art. 24 (c) of that regulation was inconsistent with 
the TBT Agreement. He recalled that Art. 24 (c) s tipulated that the labelling of an organic product 
should contain an indication of origin of the raw mate rials in one of the following three forms: either 
                                                      
11 http://www.cpsc.gov/ G/TBT/M/49  
Page 40  
 
  EU Agriculture,  non-EU agriculture or EU/non-EU agriculture when a part  of the raw material 
originated from the European Communities and other pa rts came from third countries.  He noted that 
this regulation was part of EC legal framework whose purpose was to "guarantee fair competition as 
well as ensure that consumer confidence in products  labelled as organic is justified". He explained 
that the organic nature of a product was guaranteed by the fulfilment the EC's regulations on organic 
labelling, which was independent of the origin of  the raw materials. He therefore argued that 
distinguishing between EU and non-EU origin of ra w materials had no bearing on the organic nature 
of the final product and could thus not be justif ied by the objective of preventing consumers from 
being misled. In addition, he emphasized that th e regulation was neither based on an international 
standard nor on scientific evidence. Argentina's vi ew was that this regulation created an unnecessary 
barrier to international trade b ecause origin-based organic labelling distinctions appeared to be 
unnecessary and without legal justification. Despite  the fact that the European Communities had 
informed the TBT Committee in the July 2008 meeting that Art. 24 of the regulation 834/07 would not come into force until 2010, Argentina considered  that this delay was insufficient to provide a 
substantive solution to its concerns and urged the European Communities to review Art. 24.  
181. The representative of th e European Communities
 recalled that Council Regulation (EC) No. 
834/2007 on organic farming - in particular as regards labelling rules on origin - had been discussed 
previously in the TBT Committee, as well as in bilate ral meetings with Argentina. She explained that 
the Commission's views remained that there wa s no evidence that the new labelling rules would 
negatively impact sales of products from Argentina, or  other origins, on the EU market. She stressed 
that the application of Art. 24 of this regula tion had been postponed until July 2010 as the new EU 
organic logo was not yet in place. From July 2010,  the new logo would be applied to all organic 
products throughout the European Communities. She st ressed that the placeme nt of the EU organic 
logo was currently voluntary, but would become mandatory as of 1 July 2010 for pre-packaged food originating from EC member States. The EU orga nic logo would continue to be voluntary for 
imported products after this date. She noted th at the new logo would help reassure European 
consumers that the products were of genuine  organic origin. The European Communities was 
confident that many Argentine organic products would be able to use this logo and that the labelling 
requirements on origin would not result in adverse trade effects. 
(xvi) European Communities – Seal products 
182. The representative of Norway
 reiterated his delegation's concern about the European 
Commission's proposed regulation concerning trade in seal products. 
183. The representative of Canada  informed the Committee that her delegation had requested 
dispute settlement consultations with th e European Communities on this issue. 
184. The representative of th e European Communities  noted that it was not appropriate to further 
discuss this issue in the TBT Comm ittee given that the matter would be  discussed in the context of the 
Dispute Settlement Understanding.  However, th e EC delegation remained open to discuss with 
Norway the regulation and implementing rules that would be adopted. 
(xvii)  India – Prevention of Food Adulteration (G/TBT/N/IND/34)  
185. The representative of the European Communities  reiterated her delega tion's concern regarding 
India's amendment of the Rules on the Preventi on of Food Adulteration (G/TBT/N/IND/34) which 
outlines mandatory labelling guidelines for pre-packaged food.  She noted that in November 2008 the European Communities had submitted comments on this measure, had raised the issue at the last two 
TBT Committee meetings, and had outlined its con cerns with India bilaterally on several occasions.  
However, the European Communities had not receive d a reply to its written comments, nor to its 
requests for clarification on the various revisions to  these rules, which had been notified by India to  G/TBT/M/49  
 Page 41 
 
 
  both the TBT and SPS Committees.  Furthermore, sh e noted that various attempts by the EC 
delegation in New Delhi to set up technical meetings with the Indian authorities to obtain more clarity 
on the implementation of these measures had so far been unsuccessful.  The European Communities 
urged India to provide an answer to its written co mments and to provide info rmation with regard to 
the current state of play of the application of these measures given that the grace period allowed for 
economic operators to adjust to the new requirements had expired in June 2009.  
186. The representative of India  indicated that she was not in a position to answer the questions 
posed by the European Communities but would co nvey the concern raised back to capital.  
(xviii)  Chile – Cosmetics (G/TBT/N/CHL/81 and Add.1) 
187. The representative of the European Communities  reiterated her delegation's concerns 
regarding notification G/TBT/N/CHL/81 and Add. 1 from Chile.  She noted that the European 
Communities had recently held fruitful bilateral discussions and  hoped that a written reply to 
comments raised would be sent soon. 
188. The representative of Chile  noted that lengthy bilateral discussions had been held.  She said 
that an expert from the Ministry of Health had informed her delegation that the amendment process, 
based on the analysis of the comments received duri ng public hearing, was still underway.  Chile's 
representative noted that her country would make th e necessary amendments to the document taking 
into consideration the comments received, includ ing those from the European Communities.  She 
stated that there was nothing new to report sin ce the last EC-Chile bilateral meeting held on 
25 September 2009 and noted that any new deve lopments would be passed onto the European 
Communities immediately. 
(xix) Colombia – Quality and Identity Requiremen ts for Distilled Spirits (G/TBT/N/COL/120 and 
Add.1, G/TBT/N/COL/121 and Add.1; G/TBT/N/COL/130 and Add.1)  
189. The representative of the European Communities  noted that her delegation had sent written 
comments to Colombia regarding notifications  G/TBT/N/COL/121 and G/TBT/N/COL/130 on 19 
March and 10 September 2009, respectively.  She st ated that in previous TBT Committee meetings, 
her delegation had outlined their ma in concerns regarding the issue of alcoholic beverages, and 
referred to the minutes of those meetings for a de tailed outline of concerns.  Therefore, she asked 
Colombia to provide an update on the review pr ocess currently taking place and to clarify the 
relationship between the two drafts notified.  The EC  delegation asked Colombia to provide an answer 
in writing to the EC's comments.  
190. The representative of the United States  thanked Colombia for its written response to the 
comments provided and for clarifying and accommodating many of the concerns raised by his 
delegation.  However, after reviewing the res ponse, he noted that the United States remained 
concerned about several issues regarding Colombia’s intentions towards importe d distilled spirits.  It 
appeared that Colombia would still impose a numbe r of requirements regarding spirits’ alcohol 
content, flavour additives, ageing, and colourings .  The US representative specified that they had 
highlighted these issues in their comments and in  bilateral discussions, and had requested that 
Colombia explain the basis for its proposals in these  areas. Colombia’s use of analytical parameters 
on certain chemical constituents found in specific ca tegories of spirits was an example of a concern 
that remained.  In particular, the United States was concerned that Colombia planned to maintain 
maximum alcohol content limits for spirits, whic h would bar some exports of US Bourbon and 
Tennessee Whiskey to Colombia.  He asked whethe r Colombia could explain the scientific and 
technical basis for mandating maximum alcohol  content limits for distilled spirits.  These 
requirements, if not modified in the final measur e, could block certain US exports of gin, rum, 
whiskey, and vodka to Colombia.  The United Stat es representative noted that his country had sent a G/TBT/M/49  
Page 42  
 
  letter to Colombia outlining these concerns and he lo oked forward to further bilateral discussions.  He 
asked whether Colombia could give an update on how it planned to address the issues raised by industry and trading partners in their comments.  The US representative urge d Colombia to consider 
further revisions to its proposed requirements in light  of the continued concerns that the United States 
had raised.  He invited Colombian regulators and trade officials to participate in a video conference 
with the US to discuss the matter on a technical level.  
191. The representative of Colombia
 acknowledged that a bilateral m eeting had been held a couple 
of days prior to the TBT Committee meeting.  She also noted that Colombia had responded to the 11 
March concerns on 28 May 2009.  Her delegation did not have any prepared responses to the latest 
concerns since the contact point had only receive d the above-mentioned letter on 28 October 2009.  It 
appeared to her that the remaining concerns were i ssues of clarification rather than concerns about the 
creation of unnecessary barriers to trade.  She r ecalled that Colombia and the United States were 
parties to a free trade agreement which had been approved by Colombia and was awaiting ratification 
by the United States.  Therefore, until the treaty came into force, her country would be unable to apply 
the measures contained in that treaty.  The repres entative accepted the US's proposal to hold a video 
conference between officials.     
192. Regarding the concerns raised by the Europ ean Communities, the Colombian delegate noted 
that in March 2009, the European Communities had sent a number of observations.  After having 
received them, the technical regulation referred to  in notification G/TBT/N/COL/120 on labelling of 
spirits, had been withdrawn by Colombia as an expression of political good will.  The specific 
questions put forth several months ago on the second regulation notified in G/TBT/N/COL/121 had 
been answered in writing on 30 October 2009.  As to  the relationship between the two drafts notified, 
it was noted that G/TBT/N/COL/130 was a more recent measure which contained some emergency regulations which had to be adopted in Colo mbia because of problems with contraband and 
adulteration of spirits, which could cause grave h ealth problems and be life threatening.  The 
representative of Colombia said that they had not  received any specific questions regarding this 
document. 
(xx) Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96 and Adds.1-3)  
193. The representative of the European Communities
 reiterated her delegation's concerns 
regarding the decree from Colombia that provided th at all gasoline engine motor vehicles would have 
to be equipped with flexifuel engines.  Du ring the last TBT Committee, her delegation had 
extensively explained the concerns on this matter.  It was noted that the European Communities had 
sent detailed written comments on 1 April 2009 a nd had been informed by the Colombian TBT 
Enquiry point that it would receive a reply to those comments during the Committee meeting and that a technical committee had also been reviewing the d ecree.  The EC representative asked if Colombia 
could give a reply to its detailed comments and pr ovide updated information on the possible revision. 
194. The representative of Mexico
 associated her country with the observations made by the 
European Communities and asked if Colombia could provide an update on the draft decree. 
195. Regarding the decree on the use of biofuels in Colombia, the representative of Colombia  
noted that her country was committed to promoting the biofuels industry.  It was noted that during the 
week prior to the TBT Committee meeting, the Mini stry of Mines and Energy, the body responsible 
for the implementation of this regulation, had inform ed her delegation that in response to the concerns 
expressed, they would be reviewing the decree and would respond to the questions put forth by a 
German automotive corporation and to the con cerns submitted by the European Communities.  G/TBT/M/49  
 Page 43 
 
 
  (xxi) India – Mandatory Certification for Steel  Products (G/TBT/N/IND/32 and Add.1)  
196. The representative of Japan  noted that India had postponed the enforcement of the Second 
Order from 12 February 2009; he asked the representa tive of India to inform the Committee of future 
plans in this regard.  He explained that th ere was no use in imposing mandatory certification 
regulations on intermediate products, such as iron a nd steel products, in order to ensure human safety 
and stated that India should reconsider the introductio n of the regulation, including its withdrawal.  It 
was noted that at the last meeting, India had explained that the objectives of the regulation were minimizing power loss, structural safety, and safety when steel was being used at high temperatures.  However, he noted that the protection of consum er health or safety depe nded only on final products, 
and not on intermediate products.  This protection could be achieved by  safety regulations for the final 
products as was done in Japan.  Japan had achieved protection of consumer safety by implementing 
many strict regulations on final products, such  as the Building Standard Law or the Electrical 
Appliance and Material Safety Act. He high lighted that the Japanese Government had not 
implemented mandatory certificati on regulations on intermediate products, since such certification 
was of no use.  Moreover, the Japanese delegation as ked India to take into account the fact that the 
regulation would create major adverse effects not onl y on international steel trade, but also on the 
manufacturers operating in India – in other word s, the international competitiveness of its own 
industry would be affected.  The Japanese representa tive stated that if the regulation were to be 
enforced beginning next February as stated, it needed  to be implemented in a way that was consistent 
with Article 2.2 of the TBT Agreement, reflecting the spirit of the series of G20 Commitments, while 
giving adequate consideration to actual business transactions. 
197. The representative of India
 explained that the notification was concerned with power loss, 
structural safety, and the use of second grade steel in appliances which were causing concern in terms 
of consumer safety.  She noted that many products in India were hand-made and not mechanized and therefore the safety of the user or the consumer wa s very relevant.  Regard ing consistency with the 
TBT Agreement, she noted that this measure was covered under the TBT Agreement through 
mandatory certification on products for consumer safety. 
(xxii)  Thailand – Mandatory Certification for Steel  Products (G/TBT/N/THA/306 and Add.1) 
198. The representative of Japan
 reiterated concerns regarding Thailand’s introduction of new 
criteria for conformity assessment with the Thai I ndustrial Standard mandatory certification scheme 
announced by the Thai Industrial Standards Institute.  He stated that his delegation was raising this 
issue again because Japanese manufacturers impor ting steel from Japan had faced substantial 
problems in Thailand. He stressed that not only was it not necessary to impose mandatory certification 
regulations on intermediate  products, such as iron and steel produc ts, but, in addition, the regulation 
was inappropriate to achieve human safety.  Japan w as confident that protection of consumer health or 
safety could be achieved by safety regulations th at addressed the final products, not intermediate 
products.  Therefore, Japan strongl y urged Thailand to make the ne w regulations consistent with 
Article 2.2 of the TBT Agreement.  Moreover, Jap an reminded Thailand that as a G20 member, it 
should respect the spirit of G20 commitments. In  light of these facts, Japan recommended that 
Thailand reconsider the implementation of the regul ation including its postponement or withdrawal. 
199. The representative of Chinese Taipei  supported the comments made by Japan. 
200. The representative of Thailand  explained that the new criteria for certification, which had 
become effective on 1 May 2009, aimed at ensuring product quality through ISO 9001, as well as 
ISO/IEC Guides 65 and 67.  She noted that, compared with past regulations, th e new regulations were 
applied equally strictly to both domestic and imported products. She informed the Committee that 
difficulties in complying with the new regulations had only been reported during the transition period 
and had since been resolved.  Thailand had not r eceived further complaints on compliance difficulties. G/TBT/M/49  
Page 44  
 
  (xxiii)  India – Restriction on Chinese toys 
201. The representative of China
 recalled that as of 23 January 2009 the Indian Ministry of 
Commerce and Industry had issued and implemen ted two regulations, namely Regulation No. 82 
which imposed a general ban on Chinese toys, and Regulation No. 91 which required Chinese toys to 
comply with certain standards and conformity assessment procedures.  Neither of these had specified 
a legitimate objective, nor had they been notified to the WTO.  The representative of China was of the 
view that these two regulations accorded unfavourable  treatment to Chinese toys, in particular with 
respect to the fundamental WTO pr inciples of national treatment a nd most favoured nation treatment 
under GATT 1994 and the TBT Agreement – Article 2.1 a nd 5.1 in particular.  The regulations also 
lacked transparency.  Therefore Ch ina had requested India to withdraw the measures immediately.   
202. It was recalled that the Chinese position on this i ssue had been made clear in a submission to 
the TBT Committee (G/TBT/W/304) and had been discussed, in detail, at the TBT Committee’s 
March 2009 meeting.  At that meeting, the repr esentative of India had responded that while he 
recognized the regulation No. 91, which was a repl acement for the regulation No. 82, still was of 
concern to China, he hoped that an amicable so lution would be found thr ough bilateral channels. 
Thereafter, the Indian Ministry of Industry and Commerce had published and enforced a new 
regulation, No. 113, on 16  June 2009.  This new regulation was to replace the former one (Regulation 
No. 91) and appeared to be a step in the right dir ection.  However, China found that the discriminative 
nature – as well as other inconsiste ncies with WTO TBT Agreement – pe rsisted in the new regulation.  
China noted that the only essential modification in the new regulation was substituting "import of toys 
from China" for "import of toys".  Moreover, the ne w regulation required that imported toys needed to 
comply with four different standards, including standards prescribed in ASTM F963 or standards 
prescribed in ISO 8124 Parts 1-3, or IS standard 9873 Parts 1-3, or standards prescribed in EN71.  Mandatory testing and certification was require d but there was no indication whether toys 
manufactured domestically in India were required to meet these same requirements prescribed in the new regulation. 
203. The representative of China noted that at the l ast TBT Committee meeting, China had raised 
concerns about the national treatment of the new regulation and asked India to provide relevant 
documents which laid down the same requirements to  domestic toys.  India had responded that their 
toy industry was already complying with these standard s but had not provided China with the relevant 
documents.  Therefore, China again requested Indi a to provide written documents so as to ensure 
accountability and so as to address China’s concerns  about national treatment.  In addition, the 
representative of China recalled that at the last TBT Committee meeting, India had recognized that 
there were some problems regard ing small and unorganized toy producers on the Indian market.  
China asked India to clarify if this meant that sm all and unorganized toy producers in India had been 
granted a transitional period to comply with relevant  requirements? If so, what were the criteria for 
such “small and unorganized players”, and could fo reign small toy producers benefit from the same 
transitional period on a national treatment basis?  
204. The representative of China noted that his count ry was a world leading toy producer; he was 
confident of China’s ability to provide Indian child ren with good quality and safe toys.  However, an 
analysis of the above-mentioned four standards (t hose referred to in the new regulation) had found 
conflicting technical specifications. For example,  IS standards and ISO standards had different 
machinery requirements compared to ASTM and EN  71.  Moreover, flammability requirements and 
requirements on migratory substances differed betw een ISO standards and ASTM standards. The 
Chinese industry had complained that  the enforcement of different standards created confusion and it 
was impossible for one toy to meet all of them.  Mu ltiple requirements on toys in the Indian regulation 
also lead to concerns about unnecessary restrictions on trade.  Based on the analysis of those technical 
specifications in the four different standards, Chin a asked that India notify this new regulation to the 
WTO according to Article 2.9 of the TBT Agreement.   He also requested India to accept the Chinese  G/TBT/M/49  
 Page 45 
 
 
  standard for toys as equivalent  considering that Chinese standa rds were in accordance with the 
relevant ISO standards.  He expressed regret that th e issue had been raised repeatedly, both bilaterally 
and in the TBT Committee and that, nevertheless, severe trade restrictions persisted and were 
affecting exports of Chinese toys. China therefore requ ested India to take prompt action so as to bring 
its measures into consistency with obl igations under the WTO TBT Agreement. 
205. The representative of India  expressed regret that her delega tion had not been in a position to 
respond positively to a request for a bilateral meeti ng due to other commitments.  She noted that India 
had issued a notification (No. 113 dated 16 June 2009) amending the earlier notification (No. 91) 
whereby the import of toys had been prohibited up to  23 January 2010.  However, the import of toys 
was permitted if the toys were accompanied with certificates showing conformity to standards 
prescribed by ASTM F963, or ISO 8125, the Indian standard 9873, or EN 71.  She noted that, in 
effect, the ISO and the Indian standards were iden tical. The conformity certificate was to come from 
the manufacturer.  She also noted that toy exporters had to have the toys tested by an independent 
laboratory which had been accredited by ILAC or through an MRA a nd found to meet the 
specifications indicated above.  The certificate also needed to link the toys in the consignment to the 
period of manufacture indicated in the conformity certificate.  Clearly, considering the above, there 
was no discrimination against the import of Chinese toys since imports of all types of toys from all countries faced the same requirements.  Furthe rmore, since Indian standards conformed to 
international standards, there was no need  for flexibility vis-à-vis EN and ASTM. 
(xxiv)  France – Unique Requirements for Ride-on Lawn Mowers  
206. The representative of the United States
 reiterated his country's concerns with respect to the 
French Ministry of Agriculture’s (MoA) “skirt” re quirement for ride-on lawnmowers, a measure that 
had neither been published as part of an official la w or decree in France nor notified to the WTO.  It 
was noted that the MoA requirement for ride-on lawnmowers had already disrupted US lawnmower exports to France.  If other European Community Me mber States were to adopt this requirement, a 
significant portion of the approximately USD1 billion in annual US shipments of lawnmowers to 
Europe could be adversely affected.   
207. The United States representative said that his country did not understand the basis for the 
MoA requirement that ride-on lawnmowers be fitted with a “skirt” for bystander protection.  He said 
that both the European and American industry had claimed that the MoA had not presented any accident data supporting the need for the requirement, and they alleged that th e requirement could in 
fact increase the potential for safety problems by increasing the risk of fire caused by accumulating 
debris in the vehicle.  He stated that the MoA had not meaningfully addressed these points, except to 
cite general accident data and note that industry had made adjustments to  decrease the risk of fire that 
the skirt installation had created.  The representative of the United States noted  that the main issue 
was the lack of a fact-based justification for imposing the requirement. Moreover, the skirt requirement represented a unique French requirement  that was neither consistent with other EC 
member States’ requirements, nor based on inte rnationally developed ASTM or ISO ride-on 
lawnmower standards used worldwide.  The US representative noted that in September 2007, the 
CEN Technical Committee 144 had voted to reject the Fr ench proposal to add the skirt requirement to 
the existing CEN standard.  
208. The US delegate expressed disappointment that  the European Commission's DG Enterprise 
had confirmed its initial rejection of the Eu ropean industry petition challenging the MoA 
requirement’s conformity with the Machinery Directiv e.  He reiterated his country's request that the 
Commission share any specific accident data suppor ting the French position that installation of the 
lawnmower skirt would increase bystander safety si nce his country was still unaware of any such 
data.  He stressed that this incident had raised  serious concerns about the viability of the New 
Approach.  If the Commission allowed certain me mber States to impose their own technical G/TBT/M/49  
Page 46  
 
  requirements whenever they disagreed with the appl icable CEN standard or in advance of the CEN 
standard being finalized, without any obligation to pub lish or notify such requirements, this threatened 
the objective of establishing a common European market . It also threatened the ability of suppliers, 
both European and non-European, to do business in Eu rope.  The representative of the United States 
asked the European Communiti es to carefully consider the systemic ramifications of this case.         
209. The representative of the European Communities
 noted that there had been developments 
concerning the complaint submitted by the European ga rden machinery federation.  At the last TBT 
Committee meeting, the EC delegation had reported that the complainant had challenged the initial 
findings of the European Commission services th rough a written submission.  However, the 
complainant failed to provide evidence that woul d cause the initial determination to be amended.  
Therefore, it was noted that the European Commi ssion had decided to close the case in September 
2009. The complainant had been informed of the outcome of the procedure in writing. The EC 
representative recalled that there had been an exchange  of letters with the USTR in which all of the 
points that had been raised at the last TBT Co mmittee and reiterated today had been addressed in 
detail.  In addition it was noted that, on 8 Sept ember 2009, a specific meeting had taken place in 
Brussels with the representative of the US missi on to the European Communities to clarify the 
functioning of the market surveillance system in EC  member States and standardization developments 
in the field of safety of lawn mowers.  The EC re presentative noted that the meeting had been useful 
and constructive for all parties.   
210. Regarding the concerns raised, the EC represen tative said that he would not repeat all the 
arguments that had been developed in previous inte rventions nor would he repeat the full content of 
the letter that had been addressed to the USTR in July 2009.  Regarding accident data, it was noted 
that both the European Communities and the United St ates had records of large number of serious and 
fatal accidents involving powered lawnmowers, which had been stated in the letter to the USTR.  
According to estimates produced by the European  Union Injury Database for Home, Leisure and 
Sports Accidents, based on reports for the peri od 2002-2006, ther e had been approximately 42,000 
accidents per year requiring hospital treatment i nvolving powered lawnmowers in the European 
Communities.  The US Consumer Product Safety Co mmission had reported even higher figures, with 
about 10 per cent of the reported accidents involving children.  However, the accident data did not 
make it possible to link accidents to particular aspect s of the design of the machinery concerned.  It 
was clear that the principle risk associated with ride-on lawn mowers was contact with the blades and 
loss of stability.  However, it could not be argued that  measures should not be taken to prevent a given 
risk only because it was of secondary importance.  Furthermore, he noted that the common European 
and international standard on risk ass essment for machinery, IS0 14121 2007 " Safety of Machinery - 
Risk Assessment - Part 1:Principles",  clause 42(d), states that while underlining the importance of 
accident data, the absence of an accident record should not be taken as a presumption of low risk.   
211. Regarding the disruption of exports, the European Commission had obtained information 
which specified that most manufacturers, includi ng US manufacturers, had now developed designs 
that complied with the protection requirement of the machinery directive.  Therefore, the EC 
representative did not expect this issue to have any other effects on US exports of lawnmowers.   He 
also stressed that a flexible guard  or skirt was neither the only, nor indeed the best way of preventing 
access to moving transmission parts.  Based on info rmation gathered from industry, most of the 
manufacturers of ride-on lawnmowers appeared to have developed design solutions involving 
integrated guards instead of skirts which did not give rise to any risk of fire.   
212. On the issue of the WTO TBT notification, it  was noted that there was no French measure 
introducing a new requirement, rather it was a ma rket surveillance action aimed at assuring the 
effective application of an existing requirement.  In addition, the European harmonized standard for 
lawnmowers EN 836:1997 was being revised under ISO lead, according to the so-called Vienna 
Agreement between CEN and ISO.  The representati ve of the European Communities noted that he  G/TBT/M/49  
 Page 47 
 
 
  was confident that an agreement between the US and the EC participants to this standardization work 
would be found in order to have a revised standard  that clarified the specifications relating to the 
safeguarding of moving transmission parts in lawnmowers.  
213. The representative of the European Communities not ed that on the systemic implications for 
the New Approach, the US arguments were unfounde d.  The New Approach's more than 20 year  
history showed that it had greatly facilitated tr ade among EC member States and with third countries 
by ensuring a well-functioning internal market based on a common set of requirements. He stated that 
it was the duty of national authorities to enforce New Approach legislation and that effective 
mechanisms were in place to ensure uniformity in the implementation and enforcement in the EU 
Member States.  Where the legisl ation was of a technical nature, the assessment of a product by 
market surveillance authorities in evitably implied an assessment as to whether the design of the 
product with regard to its safety components was comp atible with the legal requirements.  Therefore, 
the EC delegation disagreed with the idea that each  and every one of these market surveillance actions 
should give rise to a separate WTO notification.  In  this case, there was no new measure as this was 
only about the enforcement  of existing legal requirements.  
214. The representative of the United States  replied that the EC’s explanation appeared to justify 
regulation without any evidence at all.  With resp ect to the fact that manufacturers had installed 
integrated guards in place of the skirts, the US re presentative made two points:  first, he noted that 
manufacturers had only installed the guards unde r duress, so that French customs would allow 
lawnmowers out of the warehouses.  Second, if they  had not designed such guards, there would have 
been a risk of fire for which those companies would have been  held liable.  The European 
Communities had cited several thousand accidents th at had occurred, but the US representative 
explained that the relevant question was not th e number of accidents but how those accidents had 
occurred and whether installing a skirt could have prevented them.  
215. The representative from the European Communities  responded that the manufacturer had to 
ensure that all the relevant risks were eliminated at the design phase and if this was not possible then 
to reduce them through integrated design measures.  He said that this was the principle that was 
applied in the European Communities and it correspon ded to the one embodied in the ISO standard on 
risk assessment methodology for machinery.  He emphasized that the Euro pean Communities would 
be content with a higher safety standard even in  the absence of data providing a clear link between a 
particular risk and injuries occurred.  
(xxv) Argentina – Testing Requirements for Impor ted Toys (G/TBT/N/ARG/51, Adds.1-4 and 
Suppl.1)  
216. The representative of China  reiterated concerns about the above-mentioned Argentine 
measure affecting the import of toys. As had been indicated at the last meeting of the TBT Committee, the Argentine regulation imposed certific ation requirement only on imported toys.  While 
the delegation of Argentina had explained that the testing and certification requirements would apply 
equally to imported and domestic toys, there was no thing in the regulation itself that imposed such 
requirements to domestic toys.  China invited the Argentinean delegation to provide specific 
information in this regard.  In addition, although Ar gentina had made a commit ment to limit the time 
for delivering testing reports to 60 days, the Chin ese industry was still suffering from substantial time 
delays. These delays – and associated expenses – ha d been exacerbated by requirements for import 
licenses after certification. In total it took more th an 200 days to import products into Argentina, 
sometimes even more than 300 days which made it impossible to import products for a particular 
selling season.  The representative of China encourag ed Argentina to take into account Members' 
comments and bring its regulation in line with the WTO TBT Agreement.  G/TBT/M/49  
Page 48  
 
  217. The representative of the United States
 supported Argentina’s objective to protect children 
from exposure to potentially dangerous substances in to ys and other children's articles.  Nevertheless, 
the United States recalled that it had raised this is sue at the last meeting of the Committee because the 
US toy industry was concerned about the need to perform the testing in Argentina, and also with 
respect to the overall lack of testing capacity in  Argentina, which could increase costs and create 
substantial delays to market, thereby disrupting trad e ahead of the critical holiday season.  In fact, it 
was the US understanding that companies exporting toys to Argentina had already experienced delays.  One US company had reported that comply ing with the in-country testing requirement had 
added more than 90 days to the process of ge tting its products to market in Argentina. 
218. Nevertheless, the representative of the United Stat es noted that it was clear that Argentina had 
been taking the concerns expressed both in the TB T Committee and bilaterally seriously. Argentina 
was working on solutions to these i ssues, including taking steps to identify additional laboratories to 
handle testing, and, in its recently-notified measure, allowing products to remain on the market if the 
supplier certified that the toys met Argentine standa rds and indicated that a request for a test report 
had been made to INTI prior to 23 September 2009.  As a short-term measure to address the current 
delays while INTI worked to reduce the time frame for certification, the United States suggested that 
Argentina could consider extending this timefra me because many suppliers were likely unaware of 
this flexibility since the notification had been  published after the 23 September deadline.   
219. The representative of the United States asked Argentina to provide an update on its efforts to 
take the concerns expressed by industry into account.  In terms of a permanent solution to the problem 
of delays, the United States urged Argentina to  consider accepting test results conducted by 
laboratories that had been accredited by an ILAC  MRA signatory, including laboratories located in 
the country of production.   The United States offe red to facilitate regulator-to-regulator discussions 
on this matter so that his delegation could shar e its experiences, having successfully implemented an 
ILAC-based testing regime for many children’s pr oducts, including, among other things, chemical 
content testing.  The United States also pointed at opportunities for participation in APEC that could 
prove valuable for Argentine regulators.  
220. The representative of th e European Communities
 associated his delegation with the concerns 
expressed by China and the United States, in particular  those relevant to long delays.  In this regard, 
the European Communities was concer ned about the apparent lack of sufficient testing capacity in 
Argentina. His delegation suggested that Argentin a consider accepting results carried out in foreign 
ILAC accredited laboratories. 
221. The representative of Argentina  noted that protecting the health and safety of children was a 
common concern to all Members: there is indeed a n eed for a high standard of security. Since the last 
Committee meeting of the TBT Committee, in June 2 009, consultations had c ontinued on a bilateral 
basis to attend to the concerns of some of the Members who had taken the floor, particularly the 
United States.  The discussion was reflected in the minutes of that meeting and the representative of 
Argentina did not intend to repeat arguments alread y made.  He drew the Committee’s attention to the 
fact that Argentina had recently submitted a new notification pertaining to this matter 
(G/TBT/N/ARG/51/Add.5, dated 19 October 2009).  This notification provided clarification with 
regard to the scope of the origin al resolution as well as instructions  for the implementation of that 
regulation. Furthermore, certain temporary flexibiliti es were granted – as had been elaborated by the 
US representative. 
222. With respect to the comment fro m China on the applicability of the measure to toys produced 
domestically, the representative of Argentina noted th at his delegation had clearly said at the last 
meeting that this resolution applied to both importe d as well as domestic products despite the fact that 
the text of the resolution did not specifically state th is.  He asked China to pr ovide evidence that this 
was not the case so that Argentina could address the issu e.  In fact, the Argentine customs authorities  G/TBT/M/49  
 Page 49 
 
 
  required the relevant requirements to be met bot h for imports and for exports, and they demanded 
documentation that attested to complia nce with the applicable regime.   
223. With regards to the comments pertaining to the recognition of foreign laboratories, the 
representative of Argentina informed the Committ ee that the Argentinean accreditation body, the 
OAA, had signed the mutual recognition agreement treaties in the context of ILAC. Therefore, it 
recognized certificates issued by laboratories that had been accredited by other bodies that had signed 
the aforementioned treaty.  He underscored, neverthel ess, that the report needed to clearly identify the 
tested articles as well as the methodology that had been used; this methodology had to be equivalent 
to the methodology used locally.  He noted that these conditions, however, had not been met in the 
few certificates that had been presented by importers to  date.  In this respect, the following flaws had 
been observed.  First, there was difficulty in de termining the traceability between the samples and the 
identification codes for the tested samples.  Second, there had been differences noted in the sampling 
methodology (it was pointed out that that Argentina like the United States carried out sampling in parts because if one analyzed a mixture of the artic le with different components made with different 
materials, there was a chance that an error woul d occur because of possible dilution and therefore 
contamination). The third flaw that had been observe d was that the samples presented in international 
laboratories were not always equivalent to  those that had been submitted for import. 
(xxvi)  European Communities – Implementing Measures of the Directive on eco-design of energy-
using products (G/TBT/N/EEC/ 208 and Add.1; 228 and Add.1; 229 Adds 1 and 2; 234 and 
Add.1; 237 and Add.1; 273 and Add.1)   
224. The representative of China
 raised concerns about several implementing measures related to 
the EC Energy-using Products (EuP) Directive.  These implementing measures covered a very wide 
variety of energy-using products, including electri cal and electronic equipment, lamps and household 
refrigerating appliances.  While the representative of China fully supported the objectives of saving 
energy and natural resources by increasing energy efficiency, he was highly concerned about the 
potential adverse impact of these measures on intern ational trade.  China had sent written comments 
on all these measures concerned and had also raised concerns at the March 2009 meeting of the TBT 
Committee. China's concerns were mainly about the non-use of releva nt international standards; the 
stringent nature of the energy efficiency requirement s; and the lack of consideration of the needs of 
developing country Members.  For example, in  the latest notification relating to household 
refrigerating appliances (G/TBT/N/EEC/273 and A dd.1), the notified measure required that the 
measured value should not be less than the rate d value by more than 10 per cent; however, the  
tolerance value in the relevant international st andard (IEC 62552:2007) was 15 per cent.  Although 
China had still not received a reply from the Eu ropean Communities to written comments, it was 
hoped that European Communities would take into account comments made, as well as the special 
needs and difficulties of developing country Members.  The representative of China stressed, in this 
regard, the relevance of Article 12 of the TBT Agr eement and the need for minimizing adverse affects 
to international trade. 
225. The representative of th e European Communities  pointed out that the TBT Committee had 
discussed the measures at issue on several occasions.  They were based on technical, environmental 
and economic analyses carried out in full transparen cy with the participation of stakeholders from 
around the world.  The reports were available on the EC website.12  With respect to EEC/273, China 
had indeed sent comments and a detailed reply, in writing, had been provided the day before the 
current meeting.  With regard to the specific question about the IEC standard 62552:2007, it was 
correct that Annex E of this standard described a tw o-stage verification procedure: first, the appliance 
needed to be tested with the measurement of unc ertainty of 15 per cent; and, second, three more 
appliances needed to be tested with the measurem ent uncertainty of 10 per cent. Under the notified 
                                                      
12 http://ec.europa.eu/energy/efficiency/ecodesign/forum_en.htm G/TBT/M/49  
Page 50  
 
  legislation the first step disappeared so in other words, the measurement uncertainty remained at 10 
per cent.  It was noted that the 15 per cent value for the measurements on certainty used in the IEC 
standard (for the testing of the first appliance)  had been provided to include production variability. 
However, the European Communities was of the view that variability was considered as a part of the 
overall appliance quality and needed therefore be unde r the manufacturers' responsibility.  Therefore, 
the verification of tolerances for the measurements of energy consumption and freezing capacity had 
been reduced in the notified legislation to 10 per cent from the beginning in order to leave production 
variability under the manufacturers' responsibility.  A transition period of two years had been given to 
provide sufficient time for manufacturers to adapt to this reduction of measurement tolerances. 
(xxvii)  European Communities – Decision on Restrictions of the Marketing and Use of 
Organostannic Compounds (G/TBT/N/EEC/244 and Add.1)  
226. The representative of Japan
 noted that despite receiving responses to comments made, his 
delegation remained concerned that dibutylti n compounds (DBT) had been banned although no 
difference had been found between DBT and dioctyltin  compounds in terms of risk level in the final 
RPA Report, a socio-economic impact assessment. Fu rthermore, Japan was concerned that this would 
result in an obstacle to trade for boards of highl y transparent grade, which used dibutyltin as an 
essential compound in their manufacture.  Furtherm ore, noting the risk assessment on DBT in the 
RPA Report which recommended the reduction of risk through a method that estimated the 
aggregated risk of several exposure sources, he em phasized the point that the Report of the Science 
Committee on Health and Environmental Risks (SCHER) made the statement on this method that it increased uncertainty in the assessment of exposure and need much information for the effective use 
of this method.  Japan was concerned that, desp ite this note in the Report, the process which had 
resulted in the different treatment between DBT and DOT was unclear.  Moreover, Japan did not 
consider it appropriate to expand the regula tion beyond those exposure sources which had obvious 
risks.  Therefore, the European  Communities was requested to show  the details of the scientific 
grounds on which the implementing re gulations were based. After revi ewing this information, Japan 
would consider the need to have an  expert level bilateral meeting.  
227. The representative of the European Communities
 recalled that she had explained at the last 
meeting of the TBT Committee the reasons for the different treatment of dibutyltin compounds and 
dioctyltin compounds.  The main reason for the di fference was that dibutyltin compounds had been 
classified as toxic for reproduction which was not the case for dioctyltin compounds.  The European 
Communities would nevertheless revert to Japan on this issue since more concrete, scientific 
arguments were made by Japan in the meeting; he r delegation remained open to a direct exchange 
between the experts on the matter. 
(xxviii)  China – Green Dam Youth Escort internet filtering software 
228. The representative of Japan  continued to be concerned about China's notice mandating the 
installation of the Green Dam software on all comput ers sold in China effective 1 July 2009.  This 
measure raised significant questions about security and system reliability because computer makers 
would have no choice to select filtering softwa re other than Green Dam although China had 
announced the postponement of the measure in Ju ne 2009.  The representative of Japan requested 
China to ensure that the measure would not be more trade restrictive than necessary following 
exhaustive discussions with affected Members. Japan requested China to leave the choice of filtering 
software to consumer and computer producers. 
229. The representative of China  wished to provide some clarifications.  It was recalled that access 
of minors to pornographic content on the internet  was a concern common to parents all over the 
world.  In this respect information technology provi ded an effective and cost efficient way to address 
the concern.  The so-called Green Dam Youth Esco rt had been purchased by the Chinese Government  G/TBT/M/49  
 Page 51 
 
 
  in the form of government procurement and aimed to fulfil the legitimate objectives of protecting 
minors. It had been provided to computer producer s and users free of charge and, as a result, there 
was no additional cost to computer producers.  With respect to installation, computer producers could 
install the software in computer hard-disks or with  a CD that accompanied the product.  The software 
installation process could be managed according to business practice.  Therefore it was China's view 
that there would be no significant effect on computer trade of other Members. 
230. With regard to the question about the impact of  the software on computer security and system 
reliability, the representative of China said that this  concern had been taken into consideration in the  
software development process; in fact, the security of the Green Dam software had been tested many 
times by third party testing bodies. With respect to the application of the software, just like other 
software – such as Windows – this software could be updated on-line or through updated versions on 
CDs. Hence, concerns about possible impacts on computer security, system reliability and 
compatibility had been addressed.  Moreover, if st akeholders found any other specific technical 
problems China was ready to take immediate actio n to examine and address these.  Regarding the 
request to leave the selection of filtering softwa re to consumers and to computer producers, the 
representative of China noted that since the Green Dam Youth Escort Software was provided free of 
charge from the government, universal access could be  guaranteed. It was China's view that leaving 
open the choice of selecting software would lead to significant costs to computer producers and users, thereby undermining the achievement of China's legi timate objectives.  In addition, this would also 
significantly affect international trade since it would not be practical for the government to buy all possible software using public money and providing these free of charge.   
231. In respect of the IPR issue that had been pr eviously raised, it was noted that the Chinese 
Government had attached importance to IPR issues from the very beginning. As a buyer the Chinese 
Government had required the supplier to provide software with IPRs once a contract was negotiated.  
Additionally, if there was any complaint about an IPR issue it would be addressed adequately through 
the Chinese domestic legal system. To date  no such case had been filed in China. 
(xxix)  Korea – Regulation for Food Industry Pr omotion Act (G/TBT/N/KOR/204 and Suppl.1) 
232. The representative of Canada
 noted that her delegation had a number of outstanding concerns 
on this measure despite some clarifications provide d to its Enquiry Point on 17 April 2009, as well as 
bilateral meetings held.  Most importantly, Canada reiterated its request to Korea to extend its 1 
January 2010 implementation date on the proposed regime. If Korea did not extend its implementation 
date, it appeared that there woul d be no viable option for Canadian  organic producers to have their 
products accredited under the Korean Organic standa rd and therefore Canadian organic products 
would not be able to be exported to Korea.  An extension granted for foreign certifiers and companies 
would allow them time to review the final Kore an organic regime and comply with the organic 
standards. Canada understood that the proposed amendm ents to the regime had not yet been finalized 
and that final versions of regulations were not ava ilable.  The representative of Canada asked Korea to 
indicate when the final versions of the amended regu lations would be available.   As per the principle 
set out in the TBT Agreement, as well as in Codex,  she hoped that Korea would use the delay in the 
implementation date to include provisions in their regime which allowed for equivalency agreements.  
Canada would welcome the opportunity to work to wards developing an equi valency arrangement on 
organics with Korea. 
233. The representative of New Zealand  associated herself with the points made by Canada.  New 
Zealand understood that the Republic of Korea’s Ministry of Food, Agriculture, Forestry and 
Fisheries had signalled that it would delay im plementation of the new regulations until 
1 January 2011.  Could this be confirmed? While the representative of New Zealand welcomed this 
delay, she remained concerned that the new re gulation failed to provide for the recognition of 
equivalence; she urged the Republic of Korea to  consider equivalence agreements with the G/TBT/M/49  
Page 52  
 
  International Organic Certification Agency (IF OAM) and/or foreign governments before the new 
regulation took effect. 
234. The representative of the European Communities
 joined other delegations in expressing 
concerns about the measure at issue.  Comments had been sent in April 2009 and a reply had been 
received from Korea on 20 October 2009. However, the information provided in the reply did not 
fully address the EC concerns.  As had been previ ously stated, the European  Communities was mainly 
concerned with the fact that the Korean regula tion did not foresee accepting legislation of other WTO 
Members as equivalent.  In the view of the Europ ean Communities, this practice was not in line with 
the Codex Alimentarius Guidelines for the prod uction, processing, labelling and marketing for 
organic foods, which encouraged the principle of e quivalence to be applied for imports of organic 
products.  The European Communities was also con cerned about the fact that foreign certification 
bodies that had been accredited in their country of orig in needed to be re-accredited in Korea in order 
to be able to certify organic products for the Korean market. In this respect, the European 
Communities drew the Committee's attention to the fact  that in order to be accredited in the European 
Communities, these certification bodies had to undergo a strict approval process followed by close 
supervision by competent authorities in EU member States. In addition, in order to provide ever 
greater assurance of their testing and certification ability, as of 1 January 2009 all European certification bodies also had to be accredited to th e standard EN 45011, equivalent to the ISO 65 
Guide.  
235. The representative of the European Communiti es noted that a large number of European 
operators exporting organic food to Korea were  small and medium enterprises (SMEs), which 
produced relatively small consignments of organi c products for export to Korea. The European 
Communities was concerned that the high administra tive burden that these operators would be faced 
with in order to certify their products in accordance with Korean standards, would lead many of these 
companies to withdraw from th e Korean market. The European Communities therefore urged Korea 
to outline the reasons for which the Codex Guide lines for organic foods had not been taken into 
account. The European Communities also invited Ko rea to consider recognizing the system for 
organic production applied in the European Communiti es as equivalent to the Korean system so as to 
avoid further certification. To this end, the Eur opean Communities would be pleased to provide Korea 
with the necessary information on the European Communities' organic production framework in order 
to facilitate an equivalence assessment. Finally, in or der to avoid possible trade disruptions in light of 
the imminent entry into force of these requireme nts, the European Communities asked the Korean 
authorities to postpone the implementation of th e measures at issue – currently foreseen for 
1 January 2010 – by at least one year.  
236. The representative of Switzerland
 noted that the new Korean regulation for organic processed 
foods was scheduled to enter into force on 1 January  2010.  As a consequence, products certified to 
their national organic programmes, and previously  recognized as organic in Korea, would no longer 
be recognized as such unless Korea provided procedur es for equivalence or recognition.  However, it 
was Switzerland’s understanding that Korea's enfo rcement regulations did not provide adequate 
procedures for recognizing a foreign government's conf ormity assessment system, nor did they appear 
to contain procedures for determin ing equivalence. The representative of Switzerland asked to what 
extent the Codex Principles for Food Import and Export Inspection and Certification had been taken 
into account in the drafting of this measure. Sw itzerland was concerned that market disruption and 
unnecessary costs would result and asked the Korean  authorities for clarification, especially 
concerning import provisions and procedures to be followed. A number of technical questions still 
needed further clarification.  Gi ven the fact that this would ta ke more time and that economic 
damages needed to be avoided, Switzerland proposed that Korea extend the deadline for 
implementation from 1 January 2010 to 1 January 2011. This would allow the various parties to 
consult with the Korean authorities and to clarify the future modalities in trade.   G/TBT/M/49  
 Page 53 
 
 
  237. The representative of Korea  recalled that some of the issues raised had been discussed at the 
previous meeting of the TBT Committee and furthe r discussions had been held bilaterally in the 
margins of the current meeting.  He confirme d that the programme w as aimed at improving the 
quality of organic processed food, encouraging its  production, and protect ing consumers.  The 
certification system was basically quite similar to th at used in the United States and Japan where the 
certifiers applied for accreditation at the Ministry of Food, Agriculture, Forestry and Fisheries and be 
approved as the Certification Authority under the regulation.  The representative of Korea also confirmed that the notification of the introduction of  this programme to the WTO had been made in 
February 2009 and the implementation of the progr amme was scheduled for 1 January 2010.  Korea 
was open to the comments and concerns regardi ng implementation and was considering to amend 
requirements regarding the number of the certification inspectors. 
(xxx) European Communities – Poultry Meat  (G/TBT/N/EEC/267 and Add.1)  
238. The representative of Brazil
 noted that his delegation had outstanding concerns about the 
impact of proposed amendments to EC Regulation 1 234/2007.  In particular, Brazil was concerned by 
the fact that the new labelling rules for poultr y meat preparations would have a de facto 
discriminatory effect against non-EU producers of pou ltry meat. As a direct result of the regulation, 
only poultry meat produced in the European Comm unities would be allowed to be used in poultry 
meat preparations labelled as "fresh poultry meat preparations". Countries like Brazil that had to 
freeze poultry meat before export to the European Communities, would not be able to supply poultry 
meat to the EU market for preparations becau se the regulation did not foresee any labelling for 
preparations made of frozen poultry meat. In Brazi l's view there was no reasonable justification to 
prevent the use of frozen poultry meat in prepar ations.  The European Communities had suggested 
that the changes were due to the need to inform consumers; however , in Brazil's view, this did not 
have to have the effect of cutting off the possibilit y of using frozen poultry meat in preparations.  The 
legitimate objective of informing consumers about the characteristics of poultry meat preparations 
could be achieved through other less restrictive appr oaches. Brazil had suggested that for preparations 
made of frozen poultry meat a specific label such as "preparation made of previously frozen poultry 
meat" could be used. This alternative would gi ve consumers a wider range of options without 
impeding trade. However, the European Commun ities had disregarded this suggestion.  The 
representative of Brazil urged the European Comm unities to revise the newly adopted regulation, 
which Brazil considered could constitute a major obs tacle to trade under the TBT Agreement.  Brazil 
would closely monitor the implementation of these ne w measures as it evaluated what action to take 
so as to defend its commercial interests. 
239. The representative of Australia  asked for some assurances that  the amendments proposed by 
the European Communities would not result in unn ecessary restrictions on trade.  Australia was 
concerned by the inconsistency between the EC Hy giene Regulation 853 of 2004 on the definition of 
fresh meat and the new EC marketing standard for fresh poultry meat.  She asked the European 
Communities to explain the basis for deviating from the definition contained in its own hygiene 
regulation.  Australia considered that poultry that had been quick frozen for transport and/or storage 
and then thawed for retail trade was safe and whol esome.   Moreover, Australia drew the Committee's 
attention to the existence of technology that coul d fast-freeze fresh product and then deliver a product 
of highest quality after defrost.  Utilizing this tec hnology, product integrity was maintained during the 
freezing process and could be delivered into the reta il store in a controlled manner.  The technology 
ensured that product arrived in the store at a deep chilled temperature, just below 0 degrees 
centigrade.  Organoleptic trials and scientific data had confirmed the integrity of the product during 
the fast freezing process and had shown them to  be of the same quality as fresh product.  
240. The representative of Australia was of the unde rstanding that the European Communities was 
seeking to address consumer preferences. However it was not clear how the new marketing standards 
would address consumer preferences or, indeed , how it would address consumer concerns.  G/TBT/M/49  
Page 54  
 
  Clarification was sought in this regard.  Australia  also sought advice from the European Communities 
on whether alternatives had been considered, such as those suggested by Brazil.  Such alternatives 
could include the label: "previously frozen or ch illed" product rather than implementing what 
appeared to be a ban on selling thawed product.  Such a ban effectively favoured local producers over 
more distant producers where freezing was the only practical way of getting it to the market. 
241. The representative of the European Communities
 referred to bilateral exchanges that had 
taken place prior to the Committee meeting and stressed , in particular, the fact that existing rules – 
which had been in force since 1991 – already prev ented defrosted poultry meat from being sold as 
"fresh". Therefore the proposed new rules were simp ly an extrapolation of the rules that already 
applied to poultry meat and were aimed at ensuri ng that consumers were duly informed about the 
products they purchased.  It could not be disputed that consumers that bought a preparation which was 
labelled as "fresh" expected it to be indeed fresh and not one which contained defrosted poultry meat. 
For this reason the proposal put forward by Brazil for using an alternative label stating "previously 
frozen" had been discarded.  Moreover, the current proposal did not ban the sale of frozen poultry 
meat preparations; it simply restricted the use of defrosted poultry meat in preparations which were 
sold as "fresh".  Frozen poultry meat could still be  sold in the European Communities and be labelled 
as frozen.   
242. In addition, the representative of the Europ ean Communities noted that after a thorough 
analysis of the Brazilian comments, it had been c oncluded that there would be no substantial trade 
impact since the vast majority of the EU impor ts from Brazil were either poultry products or 
preparations, for which the proposal did not intro duce any new provisions. The only goods that could 
be affected by the new requirements were frozen filets  that were currently used for preparations sold 
as fresh – but these represented a very small fracti on of Brazil’s exports of poultry meat into the 
European Communities.  The EC representative adde d that the marketing standards, adopted on 
19 October 2009 would go into for ce in May 2010 – this period assu red that operators would have 
sufficient time to adapt to the new rules.  
243. With respect to the possible inconsistencies between the definition on the hygiene standards 
and that of the proposed regulation, the representa tive of the European Communities noted that the 
hygiene rules, in general, did not have the sam e purpose as marketing standards. The purpose of 
hygiene rules was to ensure that the food which was put on the market did not present any risk to 
human health. Marketing standards did not deal with  sanitary issues but guaranteed a certain level of 
quality and ensured that the products put on the ma rket corresponded to consumers expectations.  
From a hygiene perspective, fresh meat was defined in the EU legislation as meat that had not 
undergone any preserving process other than chilling, freezing or quick freezing, including meat that 
was vacuum wrapped or wrapped in a controlled at mosphere.  The term "fresh", however, was not 
linked to the term used in the commercialization of the product. In other words, the notion of fresh in 
the marketing standards was to be considered slightly  more restrictive than the notion of fresh in the 
hygiene legislation but this was not a contradicti on.  In fact, the fresh poultry definition had been 
stricter than the hygiene definition since 1991 an d no new elements had been introduced in this 
regard. 
(xxxi)  European Communities – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152)  
244. The representative of the United States  said that his delegation continued to have serious 
concerns regarding the new accreditation framework  set out in EC Regulation No 765/2008.  This 
regulation, which would become effective on 1 Janua ry 2010 and apply to all sectors, would require 
each EC member State to appoint a single nati onal accreditation body and w ould prohibit competition 
among member States’ national accreditation bodies.  The regulation further specified that national 
accreditation bodies shall operate as public, not -for-profit entities and independently of any  G/TBT/M/49  
 Page 55 
 
 
  conformity assessment body.  This meant that only a single, government entity in each member State 
would be permitted to accredit conformity assessmen t bodies in the European Communities.     
245. The United States was particularly concerned a bout the regulation’s impact on the recognition 
of non-EU accreditation bodies under the ILAC MR A and the IAF MLA, and the acceptance of 
conformity assessments performed by ILAC MRA a nd IAF MLA accredited bodies.   It was the US 
understanding that the regulation left it to EC memb er States to decide whether or not to recognize 
non-European accreditation bodies; also, member States would have the discretion whether or not to accept conformity assessments issued by ILAC MRA and IAF MLA accredited bodies.  The representative of the United States was concerned that without clear guidance from the European 
Commission, EC member States could refuse to  recognize non-European accreditation bodies and 
conformity assessments issued by non-European testing and certification bodies.  This could both 
undermine the international accreditation system unde r the ILAC MRA and the IAF MLA and impede 
US exports to the European Communities.  
246. The United States also continued to have a number of questions about how the new EC 
accreditation framework would operate in practice – th ere were, in this regard, a number of reports 
from industry that raised concerns.  These included questions regarding: (i) the rationale behind the 
new system; (ii) how attestations of conformity assessment results issued by bodies that had been 
accredited by foreign accreditation bodies that were signatories of the ILAC MRA or IAF MLA, but that did not necessarily comply with the new accreditation requirements would be treated in Europe; and (iii) the potential impact of the new system on the international accreditation framework.  The 
United States had submitted these questions to the Eu ropean Communities with a view to setting up a 
technical discussion in the near future to discuss th ese concerns and to learn about more about the EC 
accreditation framework, including its implementation.   
247. The representative of the European Communities
 reiterated that the new accreditation 
framework was a tool in support of EC internal re gulatory policy; the effects of the new accreditation 
system needed, in the first place, to be appreciated  in relation to the EU internal market and the 
operation of the regulatory system in those cases wh ere EU legislation required mandatory third party 
assessment.  The representative of the Europ ean Communities referred to the comprehensive 
overview given at the last TBT Committee meeting on the main features of the new accreditation 
system, both with respect to internal implications a nd external effects.  It was stressed that there was 
no intention to force changes in accreditation system s or practices in third countries; on the contrary, 
the intention was to build on the existing internati onal accreditation system rather than undermining it.  
The European Communities welcomed bilateral tec hnical exchanges on the matter.  Nevertheless, 
because the issue was of potential interest to th e Committee as a whole, the European Communities 
would consider providing more ge neral information about the new EC accreditation framework under 
the Agenda Item "Exchange of Experiences"  at the next meeting of the Committee. 
III. ANNUAL TRANSITIONAL REVIEW (TRM) MANDATED IN PARAGRAPH 18 OF 
THE PROTOCOL OF ACCESSION OF THE PEOPLE'S REPUBLIC OF CHINA  
248. The Chairman  recalled that, in accordance with Paragra ph 18 of the Protocol of Accession of 
the People's Republic of China (WT/L/432), the TBT Committee would undertake an annual review 
for eight years of the implementati on by China of the TBT Agreement. 
249. The representative of the United States  highlighted some issues contained in his delegation's 
submission (G/TBT/W/324).  He welcomed the progress made at the 20th session of the US-China 
Joint Commission on Commerce and Trade (JCCC) on sever al issues that had been raised at previous 
TBT Committee meetings.  On information secur ity, he noted that China had confirmed the 
announcement made on 29 April 2009 by AQSIQ, MOF a nd CNCA, that the compulsory testing and 
certification rules for thirteen categories of in formation security produc ts would apply only to G/TBT/M/49  
Page 56  
 
  products procured by agencies of the Chinese Governme nt.  He also noted that China had agreed to 
establish a dialogue on global practices for trade in information security products.  According to the 
United States, substantial progress had also been made in the area of medical devices.  In particular, he noted that China had reassured the United Stat es that product recall regulations would not be 
duplicative or redundant, and the Ministry of H ealth and the State Food and Drug Administration 
(SFDA) would be the relevant authorities for medical  device recalls.  China had also indicated that a 
prior approval document of a medical device is sued by a foreign country would be accepted, 
regardless of whether the device had been granted a prior approval document by the country of export 
or the manufacturer’s country of legal reside nce, to satisfy any prior approval registration 
requirement.  The representative of the United States stressed that, without such changes, trade in 
medical devices would have been seriously disrupted to  the detriment of suppliers and traders, as well 
as Chinese hospitals, doctors and patients.  In add ition, he said that China and the United States had 
agreed to strengthen cooperation on standards and conformity assessment procedures, and to 
formulate a work plan for enhancing transparency  and predictability in their respective regulatory 
systems. 
250. Notwithstanding the progress in such areas, concer ns remained about a number of issues that 
had been addressed in previous Transitional Review s, including:  favouritism toward home-grown 3G 
telecommunications standards; lack of transparency with respect to certain measures;  and the failure 
to recognize the results of conformity assessme nt procedures conducted by accredited conformity 
assessment bodies located outside of China. 
251. The US representative noted that his delegation had significant concerns about China’s use of 
China-specific standards in the telecommunications ar ea, especially with regard to the Wireless Local 
Area Network Authentication and Privacy Infrastructure, or WAPI, standard.  He explained that China’s Ministry of Industry and Information T echnology (MIIT) had recently established a process 
for approving hand-held wireless devices such as cell phones and smart phones that are Internet-
enabled.  In September 2009, MIIT had indicated to US government officials that devices using WiFi, 
(ISO/IEC 8802-11), the relevant international standa rd, would only be approved if also enabled to 
support the WAPI standard.  MIIT officials had indicated that no published or written measure containing this requirement existed, and China had not notified this requirement to the WTO.  Could 
China explain why it required that mobile handsets be WAPI-enabled, especially given that the United 
States was not aware of any other government that had mandated a particular commercial security standard?  Could China further explain why it mandated compliance with a non-consensus based 
standard that did not appear to have been devel oped in an open and transp arent process, when there 
was a relevant international standard thatwas in widespread use in the global marketplace?  Could 
China clarify why the WiFi standard was ineffectiv e or inappropriate to achieve China’s objectives?  
Given that services and devices based on WiFi alone we re widely available and legally sold in China, 
what was China’s justification for requiring type a pproval in this sub-sector of the mobile equipment 
market?  And finally he asked what China’s just ification was for not mandating these particular 
technical regulations through written and published regulations, in an area as broad as type approval 
and network access for mobile devices in the world’s leading mobile handset market?  
252. With respect to conformity assessment proce dures, the United States noted that the TBT 
Committee had developed an Indicative List of Approaches to Fac ilitate Acceptance of the Results of 
Conformity Assessment ,
13 which included several approaches for accepting the results of conformity 
assessment, including test results performed by la boratories located outside the territory of the 
importing Member.  This list included use of accreditation to qualify conformity assessment bodies.  It was also recalled that there was a variety of  accreditation approaches, and that one approach 
successfully employed by several Members consiste d of the use of accreditation by International 
Laboratory Accreditation Cooperation (ILAC) Mutu al Recognition Arrangement (MRA) Members as 
                                                     
 
13 G/TBT/1/Rev.9, Annexes to Part 1, Section A.  G/TBT/M/49  
 Page 57 
 
 
  a basis for accepting test results performed by la boratories outside the territory of the importing 
Member.  Had China considered utilizing this mech anism, or another mech anism such as government 
designation or recognition of foreign testing labor atories, as a basis for accepting test results 
performed by laboratories outside its territory, including with respect to the China Compulsory Certification (CCC) Mark and SFDA requirements?  In concluding, the US representative noted that a 
further discussion on China's consideration of alte rnative approaches for accepting the results of 
conformity assessment could be helpful, especia lly in the context of the JCCT outcomes. 
253. The representative of Japan
 referred to his delegation's submission (G/TBT/W/325).  He 
noted that the "Instructions on factory inspections" intended to be referred to when conducting factory 
inspections had been uploaded on the website of  the designated certification body under the China 
Compulsory Certification (CCC) scheme.  In this re gard, China was invited to provide clarification on 
the legal relationship between such instructions and the mandatory requirements under the CCC scheme.  Japan's view was that th e instructions on factory inspection uploaded on the website of the 
certification body were for reference purposes only and did not entail any mandatory requirement.  
Could China confirm this? 
254. Japan was also concerned that China had adopted  certain national standards that appeared to 
deviate from the relevant international sta ndards, causing unnecessary confusion among foreign 
companies.  In particular, the Japanese delegati on drew the Committee's attention to the voluntary 
national standard for labeling GB/T 191:2008, in which the calculation method for maximum 
allowance of piling up of cardboard boxes differed from the relevant in ternational standard.  Although 
GB/T 191:2008 was a voluntary standard, China made a reference to it in its mandatory standard 
GB 5296.2:2008.  Therefore, Japan's vi ew was that GB/T 191:2008 constituted a de facto  mandatory 
standard.  According to Article 2.5 of the TBT Agreement, Japan requested China to explain the 
justification for referring to this national sta ndard and the objective sought.  China was also 
encouraged to align this standard with the relevant international st andard, according to Article 2.4 of 
the TBT Agreement.  Finally, the representative of Japa n noted that concerns remained with regard to 
the Chinese regulations mandating certification on IT Security Products, and those had been 
addressed under the Specific Trade Concerns part of the Agenda. 
255. The representative of the European Communities
 highlighted some points in his delegation's 
submission (G/TBT/W/326), and noted that this document identified areas where progress had been made as well as areas where concerns remained.  Nevertheless, he expressed satisfaction with the well functioning regulatory dialogue between China and the European Communities. 
256. The European Communiti es wished first of all to raise some systemic concerns. On good 
regulatory practice, it welcomed efforts made by Ch ina and highlighted the si gnificant increase in the 
frequency of public calls for comments.  The importa nce of ensuring transparency in the regulatory 
process both in the development and enforcement of regulations was emphasized.  Likewise, the 
importance of ensuring that all existing requireme nts which economic operators needed to comply 
with be made publicly available was stressed.  In Chin a this did not appear to be the case in all sectors 
and significant differences existed for regulations un der the responsibility of different Ministries.  The 
European Communities was particularly concerned about existing practices in the ICT area, where 
various mandatory requirements had been introduced  without being notified to the TBT Committee or 
even without prior internal notice.  In particular, the EC representative referr ed to several concerns 
previously raised in the Committee, such as the WAPI  standard, the green dam internet filter, and the 
unified charger for mobile phones.  China’s Ministry of Industry and Information Technology (MIIT) was therefore invited to reconsider its practices in  accordance with the transparency provisions under 
the TBT Agreement.  China was also encouraged to  systematically use regulatory impact assessment 
tools, at least in those cases where regulations had a significant impact on international trade.  It was 
the European Communities' view that the introducti on of Regulatory Impact Assessments could help 
to achieve a better balance between the legitimate regulatory objectives pursued and the need to keep G/TBT/M/49  
Page 58  
 
  the level of regulation proportionate to the risk s being managed.  The European Communities was 
willing to share experience with China on its ow n Regulatory Impact Assessments and intensify 
bilateral cooperation in this regard. 
257. Second, the EC representative noted his delega tion's concern with regard to the level of 
regulation in China.  He noted that the Chinese a pproach was characterized by a systematic use of 
mandatory standards combined with third party c onformity assessment, without any genuine attempt 
to modulate the intensity of regulation (including the stringency of the conformity assessment procedures) depending on the type of risk to be managed. This resulted in a cumbersome system 
especially for Small and Medium-sized Enterpri ses (SMEs) exporting to China without a direct 
presence in the country.  In this context, he reiterated concern about the Chinese Compulsory 
Certification (CCC) system, which was detailed in th e EC submission and had been previously raised 
in the Committee.  Despite some positive steps,  the CCC system remained a major obstacle for 
foreign companies exporting to China.  In particular , China was invited to review the “one size fits 
all” approach based on comprehensive third-party testing and factory audits, which assigned the same 
high level of risk to all products within the CCC sco pe, despite their different health and safety risks 
levels.  It was the EC delegation's view that alte rnative approaches had to be considered by China, 
such as Supplier's Declaration of Conformity for lo w-risk products, for instance low voltage and ICT 
products.  A choice between quality assurance a nd product verification conformity assessment 
modules needed to be offered where third-party assessment was required.   
258. The European Communities joined the United States and Japan in requesting that China 
provide wider acceptance of foreign test results and explain what mechanisms were in place or were 
being considered in order to facilitate the acceptance of foreign test results.  In the meantime, the EC 
representative invited China to give positive cons ideration to the proposals for short-term 
simplification of certain aspects of the current CCC system, as outlined in the EC submission 
G/TBT/W/326 and in the submission made on the occasion of the previous Triennial Review.
14  On 
the same topic, the European Communities also noted that Chin a maintained an overly detailed 
regulation in specific sectors, such as the mobile phones area.  There was also a tendency to regulate 
qualitative aspects of products that in most economies were instead left to the market, as for instance 
in the textile field with regard to colour fasteners. 
259. Third, the European Communities raised another sy stemic concern with regard to the need for 
better internal regulatory coordination between Chinese Ministries or agencies having regulatory 
powers.  It was the EC delegation's view that  competition between Ministries or agencies over 
regulating the same product arose in a number of cases and resulted in the creation of multiple and 
partially overlapping requirements.  Examples of th is situation, such as the information security case 
and the certification procedures for ICT equipments, had already been raised under the Specific Trade Concerns item of the Agenda.  In this regard, Ch ina was invited to explain whether it intended to 
develop more effective internal regulatory coordination mechanisms. 
260. Fourth, in the area of standardization,  the European Communities welcomed the 
announcement made by the Standardisation Administration of China (SAC) in January 2009, that foreign-owned companies established in China would be allowed to participate as voting members in 
technical committees responsible for the promulgati on of national standards, pending the approval of 
the technical committee's Chairman.  The European Communities further encouraged China to ensure 
effective access of foreign-owned companies to dom estic standardization work, including with regard 
to the so-called industry standards.  On the same topic, the EC representa tive also noted that, on 
several occasions, a number of Chinese standards de viated from international standards without any 
explanation being given that the relevant internatio nal standards were inappropriate or ineffective.  
                                                     
 
14 G/TBT/W/300.  G/TBT/M/49  
 Page 59 
 
 
  Standards on wine and in the ICT fiel d were examples of this situation.  China was urged to limit such 
deviations to justified cases and provide justifications for devi ations in all the other cases. 
261. Finally, the European Communities reverted to various concerns which had been raised at 
previous triennial reviews, but that had not been addressed yet.  A common feature of these concerns 
was that problems often arose from a regulatory appro ach that appeared to depart from international 
practice.  Regarding the ICT field, the EC dele gate echoed the concerns expressed by the United 
States on the proliferation of home-grown 3G teleco mmunications standards featuring unique Chinese 
technologies.  China was encouraged to continue working with the international standardization 
community, rather than developing specific nationa l standards.  This w ould benefit all economic 
operators including China, which could take advantage of the best technology available.  In the 
mobile phone area, concerns also remained about th e systematic black listing of certain features of 
products, which prevented innovative products fro m being placed on the Chinese market.   
262. With regard to the automotive sector, the Eu ropean Communities encouraged China to join 
the United Nations 1958 Agreement on Motor Vehi cles under the Economic Commission for Europe 
(UNECE).   
263. With regard to active pharmaceutical ingredient s, the EC delegation reiterated concerns about 
the routine multi-sampling and testing practice mandated for each imported batch of active 
pharmaceutical ingredients (APIs) imported into China.  China was enc ouraged to intensify 
cooperation on quality assurance and Good Manufact uring Practices which could lead to mutual 
acceptance of quality certificates.  On pharmaceutic al products, the European Communities noted that 
registration periods in China could take three years or even more, due to a number of cumbersome, 
lengthy and costly requirements relating in particular  to clinical trial approvals.  China was therefore 
invited to expedite work towards the simplification of  the clinical trial process, and develop practices 
compatible with those developed by the Intern ational Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
264. Furthermore, the European Communities repres entative expressed concerns with respect to 
the lengthy pre-market approval procedures for non-speci al use imported cosmetics.  In particular, he 
requested China to unify the notification system fo r imported and domestic non-special use cosmetics.  
However, the European Communities considered the simplification of procedures to be only a first 
step towards lifting all ex-ante approvals for impor ted cosmetics.  China was also requested to 
develop a single hygiene standard for cosmetics that would replace the two standards separately 
enforced by the Ministry of Health on one hand, and the General Administration for Quality 
Supervision, Inspection and Quarantine (AQSIQ) on the other. 
265. Regarding medical devices, concerns remain ed on duplicative mandatory (re-)registration 
requirements enforced by SFDA and AQSIQ.  The EC representative reiterated his delegation's 
request to China to treat new or fully refurbished medical devices alike, since the existing ban did not 
appear to be justified on health and safety grounds .  China was encouraged to provide an update on 
the work under way with regard to this issue. 
266. On textiles, concerns remained about the deviati ons from international standards in relation to 
import checks.  China was invited to consider replacing systematic checks by batch with random 
checks, and to accept importers self-declarations of conformity based on tests carried out by 
international accredited laboratories.  China w as also encouraged to simplify the labelling 
requirements for textiles and footwear products.  In this regard, the proposal on textile labelling G/TBT/M/49  
Page 60  
 
  submitted in the context of the NAMA NTB negotiations,
15 was seen by the European Communities 
as an example that could inspire a simp lification of the Chinese requirements.  
267. In concluding, the EC delegate requested China to provide an update on the state of play of 
the on-going revision of Regulations for Environmental Management on the First Import of 
Chemicals and the Import and Export of Toxic Chemicals . 
268. The representative of China  referred to her delegation' s submission (G/TBT/W/327) 
providing information related to Annex 1A of WT /L/432.  In respect of the comments on China's 
implementation of the TBT Agreement's transparen cy provisions, the representative of China noted 
that, to date, her delegation ha d made 695 TBT notifications, providing in each case a sixty day 
comment period and copies of full texts of notif ied measures upon request.  Moreover, it was normal 
practice to extended this period upon a Member's request.  The Chinese representative said China was 
an active participant in the Committee's work on tr ansparency and information exchange and would 
continue this engagement. 
269. Regarding information security testing and cer tification, the representative of China noted 
that information had already been provided under the Agenda item of Specific Trade Concerns.  
However, her delegation would neve rtheless provide clarification on the existing relationship between 
information security testing and certification a nd the encryption codes regulation system.  In 
particular, the Chinese delegate recalled that, among th e thirteen products which needed to obtain the 
information security product certification, six of them contained encryption technology.  These six 
products were therefore required to pass the detec tion tests for encryption codes, in accordance with 
China’s policy on the regulation of commercial encryp tion codes.  It was further clarified that the 
State Encryption Administration Authorities (SEAA) we re responsible for the testing of encryption 
codes, while the Certification and Accreditation Administration of the People’s Republic of China 
(CNCA) was responsible for the product certification.   The representative of  China emphasized that 
the current regulation on Commercial Encrypti on Codes had been enacted in 1999 and was 
functioning.  However, to better adapt to the latest  development of information technology, China was 
considering revising this regula tion and had started investigation and research.  Comments and 
suggestions by Members were welcomed by China in this regard. 
270. In respect of the implementation of the CCC sy stem, the representative of China noted that 
improvements were continuously bei ng made.  In the current revision of the implementation rules of 
the CCC scheme, China was committed to simplifyi ng the procedure, mitigate the burden of 
enterprises and further revise the parts and components report procedure and unit division.  It was also stressed that interested parties, such as EuropElectro , were closely involved in the process of revision.  
In this regard, China welcomed any suggestions from Members and interested stakeholders and was 
ready to continue the cooperation with the European Communities. 
271. In respect of the comments on China's conformity assessment procedures, it was emphasized 
that the regulations on Certification and Accred itation and on Management of Compulsory Product 
Certification clearly indicated how to accredit the certification bodies and laboratories to undertake 
CCC certification.  It was also recalled that th e CCC system recognized the CB reports within the 
scope of the IECEE/CB scheme.  The Chinese re presentative explained that the International 
Laboratory Accreditation Cooperation (ILAC) was th e cooperative organization of the laboratory 
accreditation agencies, and the ILAC Mutual Rec ognition Arrangement (MRA) was the key technical 
base for mutual recognition between China and other countries. 
                                                     
 
15 TN/MA/W/93/Rev.1.  G/TBT/M/49  
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  272. In respect of the comments raised by Japan on "Instructions on factory inspections", China 
confirmed that these documents were only intended to facilitate factory inspection operations and did 
not impose any mandatory requirement. 
273. Regarding the relationship between standa rds GB/T 191-2008 and GB 5296.2 2008, the 
representative of China explained that according to Article 5.2.5 of GB 5296. 2 2008:  "the products 
with special requirements in the process of transportation and stor age should be labelled with the 
graphic signs and according with the provisions of GB/T 191-2008".  She noted that, as the only Chinese recommended standard to regulate the graphi c signs of package, transportation and storage, 
GB/T 191-2008 was quoted in GB 5296.2-2008, with  the aim of protecting consumers and helping 
enterprises to harmonize their operations. 
274. On the subject of standardization, the Chinese de legate emphasized that all the foreign-funded 
enterprises legally registered in China could partic ipate in standardization activities, and all foreign-
funded enterprises could participate in the revisi on activities of China’s recommended standards as 
observers.  With regard to the questions on natio nal deviations from international standards, the 
Chinese delegation noted that China's deviations  were necessary in light of geographical and 
technological differences.  Regarding the comments on the maximum sulphur dioxide levels in wines, 
the representative of China noted that informati on had already been provided under the Agenda item 
on Specific Trade Concerns. 
275.  Regarding the concern raised by the Eur opean Communities on voluntary standards rendered 
mandatory through conformity assessment proce dures, the Chinese delegate recalled that the 
recommended standards were voluntary standards but became binding once incorporated into a 
mandatory act. 
276. With regard to the use of the WAPI standa rd, the representative of China noted that the 
Chinese operators decided that the WLAN network and relevant equipment would support both WAPI 
and ISO/IEC 8802-11 standards.  This was to en sure the safe operation of network and businesses, 
and provide the users with safer and more reli able wireless broadband co mmunication services.  
Mobile phones meeting the requirements and s upporting both WAPI and ISO/IEC 8802-11 standards 
were allowed to enter the WLAN network.  In this regard, it was also recalled that MIIT had launched 
a pilot programme of network access for WAPI and ISO/IEC 8802-11 dual-mode mobile phones.  
Enterprises were free to apply for par ticipation in this programme.  So far, more than thirty types of 
mobile phones had passed the test.  China would con tinue to improve work related to the management 
of network access of mobile phone in light of the progress of the pilot programme and market 
demand.  It was China's view that the WAPI standard did not deviate from the ISO/IEC 8802-11 
standard, it was rather a supplement that enhanced the latter.  It was also recalled that China had 
submitted the WAPI standard to the Internati onal Organization for Standardization (ISO) for 
recognition as an international standard. 
277. Regarding the draft measure on Medical Device s Registration Administration Method, China 
reassured Members that it would be notified in due time. 
278. Regarding the comments raised by Japan  on the Chinese measure notified under 
G/TBT/N/CHN/426, the Chinese representative noted  that a sixty day comment period had been 
provided but comments had not been received from Me mbers.  It was stressed that China had fully 
fulfilled its transparency obliga tions under the TBT Agreement. 
279.
 Finally, the representative of China drew the Committee's attention to a question from one 
Member regarding measures "without legitimate obj ectives". China strongly refuted the premise of 
this statement and recalled that the measure at i ssue had been notified to the TBT Committee in 2008 
(G/TBT/N/CHN/426), and that no comments had been  received even though 60 days had been G/TBT/M/49  
Page 62  
 
  provided.  The reason for the notification had been because of a deviation from certain international 
standards and China was, in this regard, in fu ll compliance with its obligations under the TBT 
Agreement.  In addition, it was noted that there w as still no definition of an international standard on 
which Members could agree.  Therefore, in reply to other Members' comments, the representative of 
China doubted that there existed a de finition of international practice. 
280. The Committee adopted
 its report of the Eight Annual Transitional Review (G/TBT/27).  
IV. TECHNICAL COOPERATION ACTIVITIES   
281. The representative from UNECE  informed the Committee that a training workshop on the 
practical application of risk assessment and ma nagement tools would be  held on 23 November 2009.16 
This workshop was being organized for market  surveillance authorities from countries of the 
Commonwealth of Independent States (CIS) in  cooperation with the Interstate Council for 
Standardization, Metrology and Certification of th e Commonwealth of Independent States.  The focus 
would be on how market surveillance authorities can  use risk assessment and management tools in 
cooperation with other stakeholders  in order to increase the effectiveness of their operation and in 
particular to fight the proliferation of danger ous and non-compliant goods on the market in that 
region. 
282. The Chairperson  drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities (G/TBT/GEN/91). 
V. UPDATING BY OBSERVERS  
283. The representative of the IEC  provided the Committee with an update on its recent activities 
in developing countries (G/TBT/GEN/92). 
284. The representative of UNIDO  drew the Committee's attention to two recent publications 
launched with partner agencies. First, he not ed that a handbook entitled "Building Trust - The 
Conformity Assessment Toolbox" covering all aspects  of conformity assessment in international trade 
had been co-published with ISO.  This publica tion could be downloaded from both the ISO and the 
UNIDO websites free of charge.  The representative of the UNIDO also brought the Committee's attention to the next edition of a publication done  within the framework of the CEB Inter-Agency 
Cluster on Trade and Productive Capacity for coordination.
17   This would contain a chapter on 
compliance, infrastructure and support services provided by the UN system in relation to conformity assessment. 
285. The representative of Codex
 drew the Committee's attention to document G/TBT/GEN/90 
containing an update of relevant  Codex work.  In addition, he informed the Committee on recent 
discussions that had taken place during the 31st Session of the Commission with respect to private 
standards.  These discussions focussed mainly on  what had taken place in the SPS Committee.   
286. The representative from UNECE   informed the Committee of the upcoming UNECE Working 
Party on Regulatory Cooperation and Standardization Policies which would take place from  
24-26 November 2009.  This session would also include a Conference on Risk Assessment and Management (mentioned above).  The Working Party would be asked to review and formally approve 
the work undertaken during 2009. This would in clude a proposal for common regulatory objectives 
initiative targeting electrical and mechanical equi pment and the recommendation to use the IECx, the 
international conformity assessment schemes under IEC, as the preferred means of demonstrating 
                                                     
 
16 http://www.unece. org/trade/wp6/documents/ 2009/2009_wor kshop.htm 
17 http://www.unctad.org/Templates/St artPage.asp?intItemID=4793&lang=1  G/TBT/M/49  
 Page 63 
 
 
  conformity.  The representative also brought the Committee's attention to two important documents 
on market surveillance that would be discussed. She invited all Members to a ttend the Working Party. 
287. The representative of ISO  updated the Committee on the state-of-play of the consultation 
process for the ISO Strategy Plan 2011-2015.  In th is regard, a series of workshops for developing 
countries would take place over the next six months with particular interest in developing countries 
input into conformity assessment and participation in the international standardization process.  He 
informed the Committee that ISO would soon be pub lishing the results of a study of the value of 
standards at a company level and a sector level. The ob jective of the study was to be able to determine 
the value of standards and therefore the participati on of industry in the standardization process and the 
benefit to industry of such participation.  ISO w ould also be conducting a joint education seminar with 
the IEC and the ITU in June 2010 so as to ra ise awareness amongst academics on the value of 
standards and the benefits to trade through their involvement in research and their involvement in 
standardization.  With respect to private st andards, the representative of ISO emphasized the 
importance of ensuring a clear understanding of  international standa rds and international 
standardization under the terms of the TBT Agreem ent and in accordance with the principles as laid 
out in the Annex to the TBT Agreement.  
VI. FIFTH TRIENNIAL REVIEW  
288. The Chairman  recalled that the Committee was mandated under Article 15.4 of the TBT 
Agreement to conduct the Triennial Review no later than the end of the third year from the date of 
entry into force of the WTO Agreement and at the end of each three-year period thereafter .  He 
stressed that the draft Report, available in all three languages in the Room (JOB(09)/97/Rev.3), was 
the product of intensive and constr uctive consultations carried out over the last few months.  It was 
also the product of a work process that had been c onsensual, structured, inclus ive and transparent.   
He thanked Members for their constructive engage ment and flexibility shown during the negotiation 
of the text which had allowed the Committee to reac h agreement.  Indeed, the report was substantive 
in nature and showed not only significant progress  made by the Committee in the past, but also 
important work that needed to be embarked on in the future.  
289. The Committee adopted  its Fifth Triennial Review Report (G/TBT/26). 
290. The representatives of Pakistan  and El Salvador  wished to put on record their appreciation for 
the Chair's efforts and those of the Secretariat in pr eparation of the Review, in particular with respect 
to the transparent and inclusive nature of the cons ultations which had allowe d also small delegations 
to participate.  
291. The representatives of the United States  and the European Communities  thanked the 
Chairman for having successfully guided Memb ers through challenging discussions, as well as the 
Secretariat for the process used and the drafts produc ed. The report was indeed  substantive in nature, 
including a range of initiatives.  The Committee woul d now need to turn its attention to addressing 
these in an efficient and effective manner 
VII. DATE OF THE NEXT MEETING  
292. The next regular meeting of the TBT Committee will take place on 24-25 March 2010 .   
 
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