RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/44 
10 June 2008 
 (08-2721) 
Committee on Technical Barriers to Trade  
 
 
 
MINUTES OF THE MEETING OF 20 March 2008 
 
Chairperson:  Mr. R.S. SIDHU (India)  
 
Note by the Secretariat1 
 
   
I. ADOPTION OF THE AGENDA ......................................................................................................... .......2  
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT........................................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 ................................................................................2  
B. SPECIFIC TRADE CONCERNS ........................................................................................................................2  
1. New Concerns ................................................................................................................... ....................2  
2. Previously rais ed concerns ..................................................................................................... ............11  
C. EXCHANGE OF EXPERIENCES .....................................................................................................................38  
1. Good Regulato ry Prac tice....................................................................................................... ............38  
2. Conformity Assessm ent Procedures ............................................................................................... .....39  
3. Technical As sistance ........................................................................................................... ................39  
D. OTHER MATTERS ............................................................................................................................... ......41  
III. THIRTEENTH ANNUAL REVIEW OF: ...............................................................................................42  
A. THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT UNDER ARTICLE 15.3 ..........................42  
B. THE CODE OF GOOD PRACTICE FOR THE PREPARATION , ADOPTION AND APPLICATION OF STANDARDS IN 
ANNEX 3 OF THE TBT AGREEMENT ..................................................................................................................42  
IV. TECHNICAL CO-OPERATION ACTIVITIES AND UPDATING BY OBSERVERS......................43  
V. DATE OF NEXT  MEETI NG........................................................................................................... .........44  
ANNEX 1 REPORT BY THE CHAIRMAN ON WORKSHOP ON  
GOOD REGULATORY  PRACTICE....................................................................................................... ........45  
 
                                                      
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/44 
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I. ADOPTION OF THE AGENDA 
1. The Committee adopted the agenda contained in WTO/AIR/3154.   
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 
2. The Chairman noted that the latest list of statements made under Article 15.2 of the TBT 
Agreement was contained in document G/TBT/GEN/ 1/Rev.7, issued on 7 March 2008.  Since 1995, a 
total of 115 Members had submitted at least one such  statement.  Since the last meeting, held in 
November 2007, Mongolia and Switzerland had issu ed revisions of their original statements 
(G/TBT/2/Add.44/Rev.1 and G/TBT/2/Add.7/Rev.1, respectively), and Israel and Colombia had 
submitted supplements to their original statements (G/TBT/2/Add.72/Suppl.1 and 
G/TBT/2/Add.18/Rev.2/Suppl.1).  It was also noted that the latest list of Enquiry Point contacts was contained in document G/TBT/ENQ/32 and Corr.1
2.     
3. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) Brazil – Toys  (G/TBT/N/BRA/259) 
4. The representative of Malaysia  raised an issue with respect to a Ministerial Act affecting toys, 
notified in October 2007 under Article  5.7.1 of the TBT Agreement as a matter of urgent protection of 
human health.  The measure had entered into force in August 2007 and no opportunity had been provided for WTO Members to make comments.  His delegation acknowledged Brazil's right to 
enforce a technical regulation for the purpose of en suring safety of toys in its market.  However, 
Malaysian manufacturers exporting toys to Brazil were encountering difficulties due to the new 
requirements for mandatory sampling and testing of  samples for all toys in selected laboratories 
situated in Brazil, and also due to the non-recognition of test reports from any other laboratory, even if 
accredited.  Additionally, the opti on of pre-market approval as an a lternative which was available to 
Brazilian manufacturers was not available to Malaysian manufacturers.   
5. The representative of Malaysia noted that b ilateral discussions had been taking place on the 
issue, and Brazil's willingness to engage in a dial ogue was appreciated.  However, his delegation was 
of the view that the regulation was not consistent with the TBT Agreement and invited Brazil to bring 
it into line with obligations under the WTO. 
6. The representative of Thailand
 echoed the concerns raised.  Her delegation understood 
Brazil's reason of consumer protection, and had no objection to the required toxicology test for toys.  
However, her delegation considered that Brazil's requirement that imported toys should be tested 
under System 7 only constituted an unequal treatment , since local products had the option of either 
System 5 or 7.  The measure was considered discriminatory in nature.   
7. The representative of Thailand requested that Brazil accept test reports of laboratories 
accredited under international umbrellas such as IL AC-IAF.  She stressed that Brazil should have 
                                                      
2  Regularly updated information on Members' enquiry points is also available on the following TBT 
webpage: http://www.wto.org/english/tratop_e/tbt_e/tbt_enquiry_points_e.htm   G/TBT/M/44 
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  confidence in the international standards that ha d been developed with the contribution of many 
Members, including Brazil.  She asked Brazil to give consideration to less trade-restrictive alternatives and stressed that, should Brazil not in troduce modifications soon, bilateral discussions 
should be pursued to settle the problem. 
8. The representative of the European Communities
 sought clarification with respect to the 
rationale for the separate certification procedures for imported toys as compared to domestically 
produced toys.  The European Commission had been info rmed by the toy industry of longer delays in 
the release from customs of imported toys due to the new testing requirements, which had been enforced due to the changes in the relevant procedural law. 
9. The representative of Brazil
 pointed out that the new requirements for the certification of 
imported toys had the legitimate objective of protec ting consumers' health, especially children, for 
whom those products were destined.  The previous  requirement for certification had proven to be 
insufficient to guarantee the safety of imported toys  and several cases of accidents related to those 
toys had been reported in 2007.  He explained that  the new requirements app lied to all imported toys, 
regardless of their brand or country of origin.  A lthough delays in the testing and certification process 
had occurred during the initial months of the impl ementation requirements, the situation had been 
normalized and the five laboratories that were a ccredited to issue these certificates were currently 
working below their full capacity.  He noted that bi lateral talks had already been held with the three 
countries that had raised concerns and that his de legation was ready to engage in further discussions. 
(ii) United States – Chemical Facility Anti-Terrorist Regulation 
10. The representative of Israel  raised concerns with respect to the list of "chemicals of interest" 
(Appendix A), published by the US Department of  Homeland Security (DHS) in the 20 November 
2007 Federal Register, that were subject to the in terim final DHS regulation on security of high-risk 
chemical facilities, published in the 9 April 2007 Fede ral Register.  His delegation was concerned that 
the United States had not submitted a notification fo r these measures, nor for the proposed list of DHS 
"chemicals of interest" (Appendix A) that was included in the 9 April 2007 Federal Register 
publication, as required under Articles 2 and 5 of the TBT Agreement. 
11. The representative of Israel noted that the DHS list of "chemicals of interest" included 
potassium nitrate and sodium nitrate, but did not include calcium nitrate.  He believed that the inclusion of potassium and sodium nitrate in the list was an unnecessary obstacl e to trade and that the 
measure could affect Israel's exports to the US mark et.  Available scientific information indicated that 
all three products were similar and had similar properties, and that they did not pose a security threat. 
Therefore, they should be treated equa lly and not included in the DHS list.   
12. It was further stressed that the products above were propellants, not high explosives, that they 
did not detonate and did not have the effect of  a bomb, since they could not destroy or cause 
significant damage to a building.  Additionally,  they were not on the Environmental Protection 
Agency’s Risk Management Program (RMP) list, nor included in the Chemical Weapons Convention 
(CWC) list of chemicals that needed to be controlle d, nor in the US Department of Transportation 1.1 
explosives list.  The representative of Israel stated  that his delegation was ready to consult with the 
US on the matter, preferably at an expert level, with the view of finding an agreed solution.   
13. The representative of Chile
 shared the concerns expressed by Israel.  Her delegation 
appreciated the willingness shown by the United St ates to discuss the DHS regulation, whose aim was 
to regulate the security of chemical facilities that were  considered at a high risk of terrorist attacks in 
the United States.  Concerns had been expressed about the inclusion in Appendix A of this measure of 
fertilizers, potassium nitrate and sodium nitrat e, which were products that Chile produced and G/TBT/M/44 
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  exported in high volumes to the US market.  She noted that comments had been submitted to the 
United States and that a response was awaited. 
14. It was stressed that the inclusion of sodium and potassium nitrate in the regulation would run 
counter to the objective declared by the DHS and w ould be inconsistent with the TBT obligation of 
avoiding unnecessary obstacles to trade.  Other chemi cals which could be more dangerous than these 
nitrates had been excluded from the regulation, or give n a less restrictive treatment than that given to 
potassium and sodium nitrates.  The representative of Chile expressed her delegation's hope that the United States would take these arguments into consid eration and that the products at issue would be 
excluded from the regulation.   
15. The representative of the United States
 pointed out that the Chemical Facility Anti-Terrorist 
Regulation (CFATS) issued by the Department  of Homeland Security established risk-based 
performance requirements to ensure the security of US chemical facilities.  As Israel and Chile had 
indicated, both sodium nitrate and potassium nitrate were included in Appendix A of this regulation, 
which contained the list of "chemicals of interest" covered by this measure.  Through a process of 
scientific and risk assessment, as well as consultati on with security authorities in other countries and 
public notice and comment, DHS had determined th at CFATS would apply to a specific set of 
substances, including certain nitrates determined  to possess the requisite precursor explosive 
properties.  
16. It was highlighted that CFTAS required handlers – for example distributors – of the chemicals 
contained in Appendix A to submit screening info rmation to DHS.  The screening information would 
be submitted in the form of a document called "t op-screen", which handlers could submit through an 
on-line procedure.  DHS had already received comple ted "top screens" from nearly all of the covered 
handlers of the nitrates subject to CFATS. 
17. The representative of the United States noted that  Israel and Chile had conveyed concerns that 
application of CFATS to nitrates would be burde nsome and could encourage farmers to use other 
fertilizers.  However, his delegation believed that the available evidence did not support these views.  
First, the United States was not alone in regula ting these nitrate substances for security purposes: 
Canada, the United Kingdom and Israel did as well.  With regards to burden, DHS had estimated that 
the average time to complete the online "top-scr een" information was 27 minutes.  Additionally, DHS 
had recently announced an open-ended exemption fo r farmers and other agricultural users from the 
screening requirement contained in this measure.  He  noted that bilateral discussions had been held 
with Chile on their concerns, including with DHS, a nd stressed that his delega tion would continue to 
facilitate information exchange with  trading partners, in order to en able their exporters to understand 
and comply with this new requirement. 
18. As for the notification, the representative of  the United States clarified that the screening 
procedure was mandated by legisla tion with implementing regulations to be developed and adopted in 
an expedited fashion.  Even within this tight ened timeframe, the DHS had provided notice and an 
opportunity for interested stakeholders to submit comment through the Federal Register.  It was his 
delegation's understanding that the Chilean fer tilizer industry had submitted comments through a 
fertilizer trade association.  Finally, the represen tative of the United States pointed out that the 
expedited process mandated by the Congress had appeared  to short circuit the US’ internal procedures 
to notify to the WTO, but that a notification w ould be submitted through the US Enquiry Point. 
(iii) Germany – Ban on Seal Products (G/TBT/N/DEU/5) 
19. The representative of Canada  noted that the German Government had notified the TBT 
Committee of its proposed regulation prohibiting the importation, processing and placing on the 
market of seal products.  Her delegation did not agree with the indication by Germany that the  G/TBT/M/44 
 Page 5 
 
 
  legislation on seals responded to tw o principal concerns: public mora lity and animal protection.  
Canada did not believe that this was an issue of  public morality.  On the second point, her delegation 
was of the view that the appro ach outlined by Germany was not ju stified, given that this was a 
humane and well-managed hunt of a sustainable natura l resource and that the methods used in the seal 
hunt compared favourably to killing methods u sed for other wild animals or livestock.  
20. The representative of Canada recalled that fact ual information regarding the management of 
seal hunt had been provided both to the European Fo od Safety Authority (EFSA) and to EC member 
States.  While their efforts to ban seal products  were perhaps well intentioned, they were both 
unnecessary and inconsistent with their trade obliga tions under the WTO Agreements.  Her delegation 
believed that the proposed German ban was, like those in force in Belgium and the Netherlands, 
inconsistent with Germany's and the European Communities' obligations under WTO Agreements.  
She urged the European Commission to take effect ive steps to discourage EC member States from 
proceeding with bans on seal products.  
21. The representative of Norway  reiterated her delegation's positio n with respect to the banning 
of imports of seal products by several EC member States.  She noted that the German notification 
stated that the importation, processing and placing on the market of seal products for commercial 
purposes into or within Germany would be prohibited and that the objectives for the ban were claimed 
to be animal health and welfare and public morals.  She stressed that, as in similar cases with notified 
import bans by Belgium and the Netherlands, her de legation could not see how and to what extent the 
appropriate assessments regarding available scien tific and technical evidence had been made.  
Norway shared the values and concerns for an imal welfare of other European countries.  
Consequently, regulations concer ning sealing had been continuously  developed and strengthened over 
the past 25 years.  Sealing was perhaps the most closely monitored industry in Norway; the hunt was 
conducted in a humane manner.  
22. It was stressed that Norway's position had been substantiated by the c onclusions of a recent 
report by the European Food Safety Authority (EFSA) to the European Commission, which had 
dispelled misconceptions that might have existed concerning the animal welfare dimension of the 
Norwegian seal hunt.  In Norway's view, the ban on seal products was not an animal welfare issue, 
nor a conservation issue, but a public opinion issue, and this was unsubstantiate d and unjustified.  The 
representative of Norway believed that a ban on imports of seals in the EC member States set a dangerous precedent for trade in animal products that were harvested in a sustainable and humane manner.  She expressed her delegati on's intention to continue to reserve its right to take any 
appropriate action to defend its interest unde r the TBT Agreement and other relevant WTO 
Agreements.  
23. The representative of the European Communities
 noted that the draft act concerning the 
prohibition of the importation, processing and marke ting of products derived from seals notified by 
Germany aimed at protecting animal life and health , objectives which were set out in Article 2.2 of 
the TBT Agreement.  She invited delegations that  had expressed concerns to provide their comments 
in writing within the deadline set.  She informed the Committee that the measure had also been 
notified to the Commission in accordance with the internal notification procedures and that it was 
being examined to assess its compatibility with Euro pean Community's legislation.  Her delegation 
was available for bilateral discussions. 
(iv) European Communities – Lighters (G/TBT/N/EEC/178) 
24. The representative of China  expressed his delegation's con cern with the draft Commission 
Decision on lighters, on which comments had been sent  to the European Communities.  In particular, 
he was of the view that the definitions of child -resistant lighters and child-appealing lighters were 
ambiguous and conceptually confusi ng.  Consequently, the objective of protecting children's safety G/TBT/M/44 
Page 6  
 
  might not be achieved.  The draft Decision provided  a definition of a "novelty lighter"; however, there 
were no procedures for determining what these lighter s were, and this would increase the uncertainty 
for manufacturers or distributors and could lead to a waste of resources and to increasing costs.  
25. It was also stressed that detailed technical info rmation such as test methods, test parameters 
and conformity assessment bodies concerning child saf ety requirements of lighters were not provided 
in the draft Decision, which could create difficulties in its implementation and unnecessary obstacles 
to trade.  
26. The representative of th e European Communities
 noted that the comments received by China 
were being examined by the appropriate services in the European Commission and that a response 
would be provided in due course.  She clarified th at that the objective of the draft Decision was to 
establish the conditions for a mandate to be given to CEN, the European Standardization Committee, 
to revise standard EN 13869 on child safety resist ance for lighters.  If this mandate was accepted by 
CEN, it would take approximately two to three year s to develop the standard and the definitions and 
test methods would be further elaborated.  Her de legation remained availabl e for additional bilateral 
discussions with China on the issue. 
(v) Canada – Mandatory Container Size 
27. The representative of the United States  raised an issue concerning mandatory container size 
restrictions found in Canada’s  regulations on processed produc ts.  It was his delegation's 
understanding that these restrictions on jar sizes fo r baby food made it difficult for US baby food 
producers to export to the Canadian market.  He noted that discussions had been taking place with 
Canadian authorities and looked forward to addition al information that Canada had promised to 
provide after consulting with the Canadian Food Insp ection Agency and the Department of Justice, so 
as to resolve the issue shortly. 
28. The representative of Canada  confirmed that additional information was forthcoming and that 
her delegation was ready to discuss the matter further. 
(vi) China – General Rules for Restricting Excessive Packaging  
29. The representative of the European Communities  raised concerns on the above-mentioned 
measure and noted that comments had been submitted  to the Chinese authorities on 27 February 2008.  
A reply had been received the day before the Comm ittee meeting and still needed to be analyzed in 
detail.  After a first reading, however, the reply did not seem to dissipate the concerns expressed.  She 
stressed that while her delegation fully supported the objective of restricting excessive packaging to 
protect the environment, there were concerns re lated to the inter-space ratio through which the 
Chinese authorities aimed at restricti ng excessive packaging.  In fact, article 5.1 of the notified text 
laid down that the packaging for certain products could not exceed a certain inter-space and a certain 
number of layers.  It was her delegation's view that this was not an effective and appropriate means of 
protecting the environment, since the measure only targeted certain product categories and concerned 
only a small portion of packaging compared to the to tal volume of packaging in China.  On the other 
hand, the measure had a significant negative impact on the product categories concerned. 
30. The representative of the European Communiti es also noted that the measure singled out 
certain products which were often premium and luxury products (like alcoholic beverages or 
cosmetics) and which were often sold in sophistic ated or gift-wrapping packaging.  Such products 
were often imported products, and c onstituted a relatively low share of the market in China.  Her 
delegation considered the measure more trade rest rictive than necessary to  achieve the legitimate 
objective pursued and de facto  discriminatory and therefore contrary to Article 2.1 and 2.2 of the TBT 
Agreement.   G/TBT/M/44 
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  31. Additional concerns were related to article 5.2 of the notified text, which provided that for the 
same products to which the above-m entioned inter-space ratio applied,  the total cost of packaging 
should not exceed 15 per cent of the commodities' factor y selling price.  It was stressed that the fact 
that packaging was costly did no t automatically mean that it had the most harmful impact on the 
environment.  China was invited to explain why it considered that there was a direct link between the 
cost of the packaging and excessive packaging. 
32. Furthermore, the representative of the European  Communities pointed out that only article 5.1 
regarding the inter-space ratio a ppeared to be mandatory and that the other provisions were 
recommendatory in nature.  She sought clarificati on as to whether importers were obliged to follow 
the other requirements or not, for example the provisi ons on the costs of packaging.  If they were not 
obliged, how would it be ensured in practice that the fulfilment of these requirements would not be 
requested by the enforcement authorities and ther efore be made mandatory in practice?  In 
concluding, the representative of the European Communities invited China to extend the transition 
period, if the measure was adopted,  from 6 months to 18 months.  If the transition period of 6 months 
was to be maintained, existing packaging woul d need to be destroyed; this would be 
counterproductive with regard to the pursued objective of the protection of the environment.  
33. The representative of China  hoped that the reply provided to the comments would address 
some of the concerns expressed.  He pointed out th at the restriction on the inter-space for packaging 
was the most direct and effective measure to rest rict extensive packaging.  The proposed 55 per cent 
inter-space ratio was based on comprehensive mark et surveys, had a sound technical foundation and 
could meet markets needs.  Regarding the relati onship between mandatory and voluntary provisions, 
he stressed that the whole article 5.1 was compulso ry, while other provisions were voluntary, and that 
only article 5.1 applied to the sales packaging.  Finally, regarding the period of implementation, he 
stressed that due consideration would be given to  the circulation period of products and that an 
interval for adaptation between six mont hs and one year would be provided.  
(vii) China – Proposed regulations on information security (G/TBT/N/CHN/278-290) 
34. The representative of the United States  drew the Committee's attention to thirteen proposed 
regulations on information security, notified by  China in August 2007.  These measures mandated a 
government certification and testing scheme for info rmation security for 13 categories of information 
technology products.  After discussing this issue with  experts in the US Government and industry, it 
appeared that these measures went substantially beyond global norms, by mandating testing and certification of information security for commercia l products.  He sought clarification from China 
about the objective and rationale in seeking to  extend certification and testing requirements to 
information technology products used commercially , given the far-reaching nature of these proposed 
regulations.  
35. The representative of the United States also not ed that new product development and design 
in the IT industry required a rather lengthy lead tim e, often several years.  Given the extensive array 
of IT products covered by these regulations, he sought clarifica tion on how implementation would 
proceed and what types of transition China envisioned.   In this respect, he st ressed that transparency 
in the development of implementing regulations fo r the certification and testing scheme would be of 
paramount importance and urged China to conduct a pr ocess that allowed meaningful opportunity for 
comment and inquiries by all interested stakeholde rs.  In concluding, the representative of the United 
States noted that further information detailing his de legation's concerns would be provided to China.  
It was also his delegation's understanding that the 13 technical regulations would be mandatory for all 
covered products as of 1 May 2009, but that the date  of entry into force had not yet been finalized.  
China was invited to confirm this understanding.   G/TBT/M/44 
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  36. The representative of the European Communities
 pointed out that an assessment of the 
potential impact of the proposed measures was being carried out.  As a general point, his delegation was concerned about the expansion of the Chinese compulsory certification system - which was considered a burdensome conformity assessment pro cedure - to new product categories.  He joined 
the United States in requesting China to clarify th e rationale for the proposed measures and their 
implications, as well as the practical application.   He also sought an update on the proposed 
implementation schedule. 
37. The representative of China
 noted that the proposed regulations aimed at protecting 
information security.  China had notified them to  the WTO and provided 60 days for comments from 
Members.  Comments had been taken into account and written replies provided.  He stressed that the 
concerns raised would be reported to capital. 
(viii) China – Wines (G/TBT/N/CHN/197) 
38. The representative of the European Communities  raised concerns about a measure on wine, 
notified by China on 2 May 2006, which imposed, among other things, a level of sulphur dioxide which her delegation considered to be unnecessarily  restrictive and which was below the levels 
established at the international level, as well as those accepted by the European Communities.  She 
noted that comments had been submitted and that a reply had been provided by China, in which it was 
clarified that China would not introduce the level wh ich had been indicated in the notification, thereby 
eliminating her delegation's concerns.  In fact, th e proposed levels would have severely restricted 
exports of sweet wines which, until the date of entr y into force of this measure, would have been 
permitted. 
39. However, it was highlighted that recent contact s with industry had s hown that the problem 
still existed and that China applied the strict levels  on sulphur dioxide that had been announced in the 
TBT notification.  The European Communities was of the opinion that the levels set were restrictive 
and should be amended to take into  account the tolerance level establis hed at international level.  In 
particular, the International Orga nization of Vine and Wine (OIV)
3, whose recommendations were 
internationally recognized, had set a limit of 300m g/l for sweet wines and 400mg/l for special white 
wines.  China was invited to promptly look into th is matter and amend the curr ently applied levels to 
those accepted by the OIV.  
40. The representative of China  pointed out that comments by the European Communities had 
already been taken into account and the measure had been amended accordingly.  For example, the 
volatile acid index had been changed to less than 1.2g /l and the levels of tolerance of methyl alcoholin 
had been adjusted to less than 400mg/l for red wine  and less than 250mg/l for white wine.  The total 
sulphur dioxide index had been deleted from the st andard and subject to the Food Hygiene Standard 
of China.  He invited the European Communiti es to address any additional comments to the TBT 
Enquiry Point in China. 
(ix) European Communities – Toys (G/TBT/N/EEC/184) 
41. The representative of China  appreciated the EC's efforts to protect human health and safety, 
but was concerned that the proposed directive could create unnecessary restrictions to trade in toys.  
In particular, the measure increased requirements on  chemical substances used in toys and imposed 
burdensome examinations on toys.  To fulfil requirements in this proposed directive, toy 
manufacturers and exporters would have to undergo si gnificant tests, which usually meant high fees.  
He pointed out that, in the toy industry, scaled manufacturers produced thousands of types of toys 
                                                      
3 http://www.oiv.org   G/TBT/M/44 
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  annually and that these increased requirements on testing and information would significantly 
increase costs. 
42. The representative of China further noted that  unsafe toys were caused by inappropriate 
design.  Therefore, he suggested that the direc tive should attribute relevant responsibility for toy 
safety to designers.  Additional concerns were re lated to uncertainty which could be caused by 
different implementation in EC member States, for instance, with respect to  market surveillance and 
to the withdrawal or recall of toys.  He expr essed his delegation's request that the European 
Communities guarantee that imported toys would not be discriminated against and treated unfairly. 
43. The representative of the European Communities  pointed out that the time for comments on 
the notification of the proposed directive was s till open and encouraged China to submit written 
comments, to which a written reply would be provided. 
(x) European Communities – Production a nd Labelling of Organic Products 
(G/TBT/N/EEC/101) 
44. The representative of Argentina  was concerned with the Regulation No. 834/07, on the 
production and labelling of  organic products, which had been notified to the TBT Committee in 
February 2006.4  In particular, Article 24 of the re gulation, entitled "Compulsory indications" 
stipulated that there should be an indication of th e origin of the raw materials, taking one of the 
following three forms: (i) "EU Agriculture"; ( ii) "non-EU Agriculture"; and (iii) "EU/non-EU 
Agriculture".  His delegation was particularly co ncerned about the situation arising from the "EU/non-
EU Agriculture" labelling option, in view of its consequences in terms of consumers perception. 
45. It was noted that, in Argentina, a product w as considered as organic if it followed certain 
manufacturing processes, irrespective of where it was produced.  The origin of a product did not have 
an impact on its organic nature and the essential item of information was whether or not the product 
was organic in accordance with internationally recogn ized certification systems.  It was stressed that 
the requirements in the EC measure could l ead to consumers having false impressions.  
46. The representative of Argentina pointed out that the "EU/non-EU Agriculture" label was not 
supported by WTO Agreements nor by Codex standa rds.  In fact, the Codex standard on the 
"Production, Processing, Labelling and Marketing of  Organically Produced Foods" (in particular 
Section 3) did not specify any obligation to list the or igin of ingredients on product labels.  He further 
stressed that Article 24 and preambular paragraphs  24 and 27 of the regulati on were not consistent 
with the provisions of the TBT Agreement pertaini ng to necessity and proportionality (Article 2.2), 
use of international standards (Article 2.4), and speci al and differential treatment  (Article 12) and that 
the mandatory indication of origin would c onstitute an unnecessary barrier to trade.  
47. It was stressed that the regulation would set an inappropriate precedent by applying 
requirements additional to international standards.  Furthermore, the mandatory indication of origin 
was not related to the actual characteristics of the food, could lead to deceptive practices, and did not 
take into account the rights of producers and expor ters of raw materials al ready certified as being 
organic under the European Union regulation. 
48. The representative of Ecuador  shared the concerns expressed. 
49. The representative of the European Communities  noted that there had been discussions with 
Argentina in the past on this issue and took note of the comments made.  Her delegation looked forward to a continued dialogue on the matter. 
                                                     
 
4 The full statement detailing Argentina's concerns is contained in document G/TBT/W/284. G/TBT/M/44 
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  (xi) South Africa – Labelling and Advertis ing of Foodstuffs (G/TBT/N/ZAF/66) 
50. The representative of the United States
 pointed out that his delegation was seeking greater 
clarity with respect to the proposed above-mentione d measure.  Specifically, the regulation created a 
list of "non-essential" foods which were foods that c ould not be enriched with vitamins or minerals 
and on which no claims could be made .  He wondered what the rationale or the criteria used by South 
Africa in developing this list ha d been and how US comments had been taken into account.  His 
delegation would welcome discussions with Sout h Africa to better understand the regulation. 
51. The representative of South Africa  took note of the comments made, which would be reported 
to the Department of Health in South Afri ca and a written response would be provided. 
(xii) Japan - Labelling Guidelines on Wagyu beef 
52. The representative of the United States  raised an issue with respect to the labelling guidelines 
on Wagyu beef, which were the result of a study pa nel on meat labelling requested by Japan’s 
Ministry of Agriculture, Forestry and Fisheries (MAFF).  Although his delegation had provided comments on the guidelines when they were initially released in January 2007, and asked additional 
questions in the context of Japan’s Trade Polic y Review, uncertainties remained about the purpose 
and status of the guidelines.  He stressed that th e guidelines could have a significant impact on trade, 
as they required cattle bearing the Wagyu  label to be born and raised in Japan even though 
characteristics of the term Wagyu , such as its quality and flavour, we re based on genetics and animal 
husbandry practices and not on where th e animal was born or raised.   
53. It was the United States' understanding that the guidelines were voluntary and that only 
members of the Meat Fair Trade Council were subj ect to them.  However, uncertainties remained 
about the relationship between the Meat Fair Trad e Council and either the Japan Free Trade Council 
(JFTC), or the MAFF.  Japan was invited to explai n the role of MAFF and the JFTC in the adoption 
and enforcement of the guidelines.  Additional clarif ication was also sought on the membership of the 
Meat Fair Trade Council and on whether its member s were involved in the distribution and sale of 
both imported and domestic Wagyu  beef and on how they would label imported Wagyu  beef under the 
guidelines.  Uncertainties existed also about the objective of these guidelines.  The logic of the 
guidelines could be applied to virtually any agricultural product, for example Fuji apples.  Japan was 
invited to explain the impact of the guidelines on US exports of Wagyu beef and, potentially, of other 
agricultural products. 
54. The representative of Australia
 shared the comments made by the United States and recalled 
that his delegation had also raised this issue in th e context of the Trade Policy Review of Japan, and 
that the replies provided by Japan were considered unsatisfactory. 
55. The representative of Japan  said he would convey the concerns expressed to the authorities in 
his capital.  
(xiii) Moldova – Draft Law on Alcoholic Beverages 
56. The representative of the European Communities  raised an issue with respect to the above-
mentioned measure, which was set out in a gove rnment decision of August 2007, modified in 
December 2007 and recently adopted by the parliament, but not yet in fo rce.  She noted that this law 
had not been notified to the TBT Committee and Members had not had the opportunity to examine the text and make comments on it.  However, informat ion from European industry indicated that there 
were elements in this law that required a TBT notification.  She wondered whether the measure would 
be notified and pointed out that her delegation considered that, pending the revision of the law by 
WTO Members, this measure should not enter into force.   G/TBT/M/44 
 Page 11 
 
 
  2. Previously raised concerns 
(i) European Communities - Dangerous Chemical  Substances - Draft Commission Directive 
amending Council Directive 67/548/EEC  (G/TBT/N/EEC/151) 
57. The representative of the European Communities  noted that, since the previous meeting of the 
TBT Committee, additional comments to the relevant notification had been received from the 
delegations of Australia, Brazil, Canada, China, Jap an, Turkey and the United States.  The European 
Communities had provided a detailed response to qu estions raised, which was publicly available on 
the Commission's TBT website.5  Bilateral discussions had also b een held with many delegations 
which had expressed an interest in the notified measure .  She pointed out that there seemed to be some 
misunderstanding as to the coverage of the EC's pr oposed Directive and stressed that only mixtures 
and preparations would fall within the scope of  the proposed classification, meaning that final 
products did not need to bear a skull and crossbon es symbol.  The label would provide information on 
the hazardous properties of the preparations, but this classification would not ban or restrict the use of these substances.  As indicated in the written repli es to comments, a risk assessment would be carried 
out before imposing any type of marketing restric tions, or setting maximum ex posure levels or bans.  
Interested stakeholders and third countries would be able to participate in this process and measures 
would be notified to the WTO at a draft stage.   
58. An expert from the DG Environment of the European Communities pointed out that two main 
areas needed to be taken into account:  the classi fication of borates and nickel themselves, and the 
downstream legislative consequences.  Starting w ith the latter, he emphasized that, within the 
Community legislation, there was no direct automa tic link between the classification of a substance 
and restrictions or bans of that  substance.  Before that could happen, the European Commission would 
have to carry out a risk assessment and any propo sal should be based on its results.  This was, for 
instance, the procedure followed in the "Cosmetics" Directive.  There was already a ban on the use of 
boric acid in cosmetics in concentrations above a set level, hence the current classification proposal 
would have no labelling con sequences on that substance.  He al so stressed that there was no direct 
link between the classification of a substance and the authorization process under REACH.  
Therefore, there was no automatism and the objective of the proposal was to provide users of the 
substances or preparation or mixtures containing these substance with sufficient information about 
their hazardous properties, in order to handle them safely. 
59. With respect to the classification itself of borates,  the representative of the European 
Communities noted that there were three main area s on which comments had been received:  (i) the 
analysis of data on animals; (ii) the analysis of available data on humans; and (iii) the "normal 
handling and use" criteria.  Regarding the criteria a pplied to animal data to reach the conclusion that 
this substance was a reproduction toxigen, he st ated that the US Environmental and Protection 
Agency (EPA) had come to the same conclusion th at this substance negatively affected reproduction 
in rats, mice and dogs.  The criteria used to apply this data was also consistent with the adopted 
criteria for reproductive toxicity under the globally harmonized system. 
60. Regarding the way in which data on humans were  treated in the classification process, the 
European Communities' position, in line with the gl obally harmonized system, was that there needed 
to be sufficient evidence to deny that data on animals were not rele vant to humans, and this had not 
been proven in the available studies on humans.  This was an inherent problem in toxicology itself and the standard and worldwide accepted approach w as to use animal models.  The representative of 
the European Communities stressed that the US EPA had come to the same conclusion regarding the 
available data on humans.  
                                                     
 
5 http://ec.europa.eu/enterprise/tbt/  
 G/TBT/M/44 
Page 12  
 
  61. On the issue of "normal handling and use" crite ria utilized, the representative of the European 
Communities stressed that the fact that limits had al ready been set for intake of borates in food or the 
concentration of this substance in  cosmetic products in many countr ies across the world, showed that 
a risk was associated with this substance. 
62. A number of the considerations utilized for the classification of borates applied to nickel  as 
well.  The representative of the Eu ropean Communities stressed that the "grouping" approach utilized 
had been evaluated and endorsed by experts of  OECD countries within the OECD chemicals 
programme.  Furthermore, as the metals indus try had stated on several occasions, the grouping 
approach could be applied with flexibility and not all the step s of the OECD guidance document 
needed to be fulfilled.  On the "normal handling an d use" of nickel, the same considerations as for 
borates applied. 
63. The representative of Cuba
 considered that the new classification of nickel carbonates did not 
have a scientific basis.  He noted that both nick el carbonates and sulphur carbonates were soluble in 
water, and that the draft Directive classified 150 nickel components as carcinogenic in Category 2, 
without any scientific evidence.  His delegation was concerned that the possible integration of this 
reclassification into the complex REACH system would have a significant impact on the nickel 
industry and a serious impact on Cuban nickel exports to the European market.  It could also have a 
negative impact on the use of nickel in stainless steel worldwide.   
64. The representative of Cuba stressed that his de legation considered that the EC draft Directive 
was not in line with Article 2.2 of the TBT Agreem ent, as it limited trade more than necessary to 
achieve the pursued objectives of the protection of he alth and the environment.  His delegation invited 
the European Communities to revise the 30th and 31st ATP draft Directives in light of the comments 
and concerns expressed, and adopt a more appropriate  and scientifically based form of classification 
for nickel components which did not affect Europ ean market access for developing country producers 
of nickel.  Also, he invited the European Commun ities to take into account the provisions on special 
and differential treatment in the TBT Agreement, in  particular Article 12.3, which provided that 
Members should take into account the special needs in the area of development, finance and trade of 
developing countries when preparing technical regula tions, so as to ensure they were not creating 
unnecessary obstacles to exporters.   
65. The representative of the Dominican Republic  shared the concerns expressed by Cuba on the 
proposed re-classification of nickel carbonates, whic h her delegation considered to lack sufficient 
scientific evidence.  She stressed that nickel exports  represented, in 2007, more than 50 per cent of the 
total exports of the Dominican Republic and that th e proposed directive would have a negative effect 
on industry and the economy of the country as a whol e.  She expressed her delegation's request to the 
European Communities not to adopt the 30th ATP Directive and to notify the 31st ATP Directive, as 
well as to take WTO Members' comments in to account before the final adoption. 
66. The representative of Brazil  thanked the European Communities for the recently circulated 
answers about the proposed classification for nickel carbonates, under the 30th ATP and welcomed the 
announcement that the 31st ATP would be notified to the TBT Committee before its adoption.  
However, without prejudging the actual risk posed by the nickel carbonates, his delegation was not convinced that the classification as proven human  carcinogens was justifia ble with the scientific 
evidence as presented by the European  Communities.  He noted that it had been argued that the 
hazardous properties listed in the 30
th ATP had been discussed by OECD experts who came to the 
same conclusions as the one proposed by the EC.  Ho wever, he stressed that the OECD study case 
was a draft initial assessment profile of nickel compound chemicals, which recognised at the outset 
that there was no data available about nickel carbona tes' carcinogenic effect on human health.  The 
main focus of the OECD study was that five subs tances were candidates for further work, since there 
were indications of risks to human health.  He pointed out that this  was not the same conclusion as the  G/TBT/M/44 
 Page 13 
 
 
  one proposed in the 30th ATP, since the latter dismissed the n ecessity for further work by skipping 
testing requirements and jumping to the conclu sion that nickel carbona tes were proven human 
carcinogents. 
67. The representative of Brazil requested to the European Commission to postpone the adoption 
of the 30th and 31st ATP until there was reliable scientific information on the actual risk posed by 
nickel compounds.  He also asked why this issu e had not been handled in the context of REACH 
legislation within existing timetables for testing and evaluation.  In this regard, industry was 
conducting a programme to generate relevant data that could cont ribute to the appropriate science 
based assessment and classification of nickel co mpounds.  Bearing in mind that TBT Article 2.2 
stated that regulations should not be more trad e restrictive than necessar y to fulfil a legitimate 
objective, Brazil invited the European Communities to wait until such data became available.   
68. The representative of Canada  pointed out that her delegation attached great importance to this 
issue.  Canada was the world's second-largest produ cer and exporter of nickel  and related substances 
and had a major interest in ensuring that the EC measures did not entail unnecessary barriers to trade.  
She informed the Committee that her delegation, to gether with eight other countries which accounted 
for more than 80 per cent of global nickel producti on, had sent a letter to European Commissioner for 
the Environment reiterating their concerns.6  A response had been received from the European 
Commission which was currently being reviewed.  Li ke others, her delegation's main concerns were 
related to the fact that the proposed classifica tion for nickel carbonates was not based on sound 
scientific analysis, and could set an inappropriate precedent.  
69. The representative of Canada sought clarificati on on:  the process used for the classification 
of nickel carbonates and the decision not to request fu rther testing; the role of water solubility in the 
process of grouping substances; the use of the OECD  guidance, particularly the verification steps 
contained within, in determining the proposed classif ications; and the rationale for inclusion of the 
OECD Draft Initial Assessment Profile (SIDS) in th e EC response.  She further noted that, in its 
response, the European Communities had indicated that the 30th and 31st ATPs would be included in 
Annex VI of a new Regulation (the "CLAP" Regul ation - Classification, Labelling and Packaging of 
substances and mixtures) which sought to bring th e EC into alignment with the United Nations 
Globally Harmonized System.  In this regard, she sought clarification on whether classifications in the proposed 30
th and 31st ATPs would be included in Annex VI of the CLAP Regulation at the time it 
entered into force or whether these ATPs would be added in the first ATP to the CLAP Regulation.  
70. The representative of Canada appreciated that  the European Communities were willing to 
analyze data submitted by industry.  It was her delegation's expectation that no adoption of the 
30th ATP would begin until a scientific analysis of su ch data had been completed.  She stressed that 
Canada was not taking a position on the toxicity or carcinogenicity of particular nickel-based 
substances; rather, it was the process by which th e European Communities had reached its conclusion 
that was of concern.  In particular, she stressed that should inappropriate approaches be taken in such 
situations, they might set a dangerous precedent for the large number of assessments to be performed 
under REACH.  She expressed her delegation's request  that such assessments be scientifically based 
and conducted in an appropriate  manner and urged the European Communities to ensure that any 
measures taken to protect human and environmenta l health represented the least trade restrictive 
options available, in conformity with Article 2.2 of the TBT Agreement.   
71. The representative of Canada also sought confirmation that implementation of the 30th ATP 
would be delayed, that scientific data submitted by industry would be analyzed, and that the delay in 
adoption would allow sufficient time for information submitted by industry to be properly considered.  
With respect to the 31st ATP Directive, it was her delegation' s understanding that this would contain 
                                                      
6 A copy of the letter sent was made available as a room document. G/TBT/M/44 
Page 14  
 
  further nickel classification proposals.  She hoped that sufficient time would be allowed for Members 
to review and comment on the draft once it was notified. 
72. The representative of Australia
 shared the comments made by previous speakers and 
appreciated the EC's response to the joint letter sen t.  However, concerns remained on the process by 
which the European Communities had assessed nickel carbonates, and on the lack of verification that 
nickel carbonates and the reference chemicals were sufficiently comparable to support the conclusions 
reached.  His delegation did not oppose the use of r ead-across methodology if applied correctly and in 
a robust and scientifically valid manner.  Howeve r, Australian assessment authorities had reviewed 
the scientific literature available on the issue, including EC and OECD documentation, and had 
concluded that there was no reliable data on the car cinogenic potential of nickel carbonates and that 
solubility in water alone was an insufficient cr iterion on which to base read-across methodologies.  
73. The representative of Australia sought clarifica tion about EC plans for the adoption of the 30th 
ATP.  He also pointed out that, in its reply, th e European Communities had st ated that any additional 
scientific information submitted by industry would be analysed by the Commission services, and that if there were merits, the classification of the nickel  compounds could be modified.  Further scientific 
work on nickel carbonates had been completed by th e nickel industry, which had been provided to the 
Communities.  Therefore, he invited the European  Communities to analyse this additional scientific 
data before taking any further steps in relation to the 30
th ATP. 
74. The representative of Australia further noted th at, in its response, the European Communities 
had stated that hazard properties of nickel compounds listed in the 30th ATP had been discussed by 
OECD experts, and that industry had provided ad ditional information which had been taken into 
account by them.  However, his delegation's understa nding was that there was no agreement and that 
the OECD was looking into producing further guidance on how to apply read-across methodology.  The European Communities had attached a draft docum ent (Draft SIDS Initial Assessment Profile) to 
its response which, they indicated, had been discussed  by OECD experts.  However, this was still a 
draft document and there appeared to be r ecommendations for further work.  Australia's 
understanding was that the process was not intende d to classify compounds, but rather involved 
verifying the quality and ava ilability of data on substances.  There appeared to be little relevant data 
in relation to nickel carbonates.  Therefore, Austra lia was interested in receiving further information 
as to the status of the document and recommendations for further work. 
75. The representative of Australia stressed that hi s delegation remained concerned that the EC 
approach to the nickel group could create a pre cedent for the manner in which other groups of 
chemical substances would be classified in future , including under REACH.   In the response to 
Australia, the EC had confirmed that the nickel gr oup did not provide a model to be used "directly" 
for other groups of chemicals.  However, the respon se also noted that Annex VI of the Proposal for a 
Regulation of the European Parliament and of the Council on Classification, Labelling and Packaging 
of Substances and Mixtures and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 
(the CLAP Regulation) would include harmonized classifications, including those of the 30
th and 31st 
ATP, and those coming from REACH, via an ATP pro cedure.  This would create a precedent, and his 
delegation was concerned about the scientific and procedural grounds of this precedent. 
76. It was also pointed out that the EC proposed cl assification of nickel substances would have a 
significant economic and commercial impact on all nickel producing and exporting countries, 
including developing countries.  Despite the i ndication by the European Communities that there 
would not be a direct consequence on other regul ations, industry had already provided examples 
where there would be a direct flow through.   
77. The representative of Australia was encouraged by the European Communities indication that 
the proposal for the 31st ATP Directive would be notified u nder the TBT Agreement and that a  G/TBT/M/44 
 Page 15 
 
 
  reasonable time for comments would be provided.  He  requested the EC to ensure that the process by 
which its chemicals regulatory regime was developed be transparent, open to all interested parties, 
including industry, and scientifically defensible.  He noted that the European Communities had stated 
in their response that the draft Directive had been  discussed bilaterally with most countries who had 
submitted comments.  However, it had been challengi ng for Australia to engage with the Commission 
on this issue, and the industry had reported simi lar difficulties.  He encouraged the European 
Communities to ensure that bilateral discussions c ontinued with all interested parties, including 
industry, and that no action to implement the 30th ATP Directive would be taken until unresolved 
issues remained outstanding. 
78. The representative of China  agreed with previous speakers and highlighted that the European 
Communities had not fully addressed the concer ns expressed by his delegation on the draft 30th ATP.  
On the 31st ATP, he invited the European Communities to  comply with the transparency obligations 
in the TBT Agreement and also to b ase this measure on scientific evidence. 
79. The representative of Chile  expressed her delegation's concern about the way in which the 
reclassification of chemicals was being conducted a nd stressed the need for the methodology used to 
determine the risks to be applied in a transparen t way and on a scientific basis.  Her delegation was 
also concerned that the reclassification process, in particular regarding nickel carbonates, would 
create uncertainties also in other areas, namely unde r REACH, and would have an impact on trade in 
these products.  It was her delegation's hope th at the reclassification be reconsidered. 
80. The representative of South Africa  echoed the concerns expressed.  In particular, his 
delegation's concerns were relate d to the re-classification of nickel carbonates.  His delegation's 
understanding was that the basis for the classification in the 30th ATP was the read-across 
methodology, which entailed reading across data from  one well characterized substance to another 
substance with little or no data.  However, whils t the read-across methodology was approved by the 
OECD (as per guidelines for its use contained in OECD’s 2004  Manual for Investigation of High 
Production Volume Chemicals), it appeared to South African industry that the EC evaluation process 
did not comply with these guidelines as the analysis of the properties of the substances compared was 
not properly conducted.  The same methodology would be used for the upcoming 31st ATP, which 
covered an additional 140 nickel substances.   
81. The representative of South Africa further pointed out that it was his delegation's 
understanding that both the 30th and 31st ATPs could be adopted before  June 2008, to coincide with 
the pre-registration period for REACH.  In f act, under REACH, nickel substances had to be 
registered.  As part of this process, industry had to provide data on the chemical composition of these 
substances following which the EC would examine such data to make a determination on their 
toxicity.  If both ATPs were adopted before th e REACH pre-registration period, South African 
industry would not be able to provide its own data  for REACH registration purposes, as the toxicity 
determination would have been c oncluded in terms of the read-across methodology applied in the 30th 
and 31st ATPs.  Of particular concern was the fact th at the proposed classification-by-derogation in 
the 30th ATP and flawed subsequent "read across" in the 31st ATP would lead to future erroneous and 
trade-restrictive measures under REACH.  Therefor e, he requested the Eu ropean Communities to 
defer consideration of both the 30th and 31st ATPs so as to allow stakeholders, including the nickel 
industry, to contribute to the evaluation process and ensure a sound science-based approach, with a 
view to ensuring that the aims and objectives of REACH were not compromised.   
82. The representative of the United States  appreciated the response provided by the European 
Communities to the comments made.  His delegation sh ared many of the systemic concerns raised by 
previous speakers regarding the EC analysis fo r classifying nickel carbonates and other nickel 
compounds under Category 2 of the Dangerous Substa nces Directive.  With respect to the proposed 
classification of borates under Category 2, he referre d to the concerns set out in his delegation's G/TBT/M/44 
Page 16  
 
  previous statements and communications.  In par ticular, the United States noted that the European 
Communities did not appear to have taken into  account the normal handling and use of borates-
containing products, when proposing its classification of borates.  
83. Additionally, the representative of the Unite d States reiterated his delegation's concerns 
regarding the labelling requirements and the "knock-on"  effects under other EC legislation, such as 
REACH, of a Category 2 classification and the potentia l adverse impacts that this could have on the 
sale and trade of borates and borate-containing products.  He stressed that concerns would continue to 
be communicated to EC officials at senior leve ls and sought information on whether the European 
Communities had considered alternative approach es to provide consumers with information on 
borates that avoided the potential adverse effects on trade associated with a Category 2 classification.  
84. Furthermore, the representative from the United States Environmental Protection Agency 
(EPA) highlighted that the characterization of the use of the EPA data by the European Communities 
was not accurate.  She was willing to further discuss th is issue at a technical level, and expressed her 
delegation's request to the EC not to finalize its  proposed Category 2 classification for borates in the 
absence of an assessment that took into account in tended end-uses and any risk associated with those 
end-uses.  A solution could be found that protected th e health and safety of consumers, while avoiding 
unnecessary restrictions on the sale and use of borates. 
85. The representative of Turkey
 referred to the concerns previously expressed by his delegation 
on the proposed classification of borates.  He recalle d that, in addition to raising concerns in the TBT 
Committee, his delegation had engaged in a bilatera l dialogue with the European Communities.  The 
European Communities had also been invited to take  part in a joint epidemiology study which would 
be conducted in Turkey's borate mines and manufactur ing sites.  Turkey had also submitted additional 
comments on the EC notification.   
86. In particular, Turkey believed that the cl assification had many procedural and scientific 
shortcomings and that although the directive referre d to risk, the decision had been taken on the basis 
of hazard.  The European Communities seemed to  rationalize its decision instead of adopting a 
constructive approach with a view to eliminating technical barriers to trade.  It was Turkey's 
understanding that the normal handling and use criteria,  the relevance of animal data for humans, the 
route and doses in the administration of substances,  the toxic genetic differences between laboratory 
animals and humans and the relevance of existing ep idemiological data had not been applied properly 
by the EC Technical Committee in reaching the classification decision.   
87. Specifically, with respect to the normal handlin g and use criteria, the representative of Turkey 
stressed that in order to increase human exposure levels within one leve l of magnitude of non-
desirable effects level for reproductive toxicity found  in animals, humans had to ingest deliberately 
large oral doses of borates, and increase such i ngestion over a certain period of time, which 
constituted a misuse.  He remarked that animal studies had been performed by the oral route.  
However, the route of exposure to borates duri ng "normal handling and use" would be dermal 
absorbsion and inhalation.  In this regard, he st ressed that borates were poorly absorbed through the 
skin and the very high exposure levels so as to produce effects by inhalation would be never met 
within "normal handling and use". 
88. On the issue of the relevance of animal data fo r humans, the representative of Turkey stressed 
that there were marked toxic genetic differences be tween live animals and humans.  For instance, rats 
had a raised risk of renal failure since they coul d not vomit, so high doses could be used in studies.  
However, humans could not ingest such high amount s of borates and, moreover, boric acid had other 
toxic effects in humans such as vomiting and diarrhoea in the intake of high doses.  He also stressed that existing epidemiological data, including occ upational and environmental human exposure studies 
carried out in Turkey and in the United States had not shown reproductive effects and had  G/TBT/M/44 
 Page 17 
 
 
  demonstrated that the effect on humans differed fro m the effects on animals tested.  It was further 
pointed out that, according to the REACH regulati on, a substance classified under Category 1 or 2 had 
to be authorized.  
89. With respect to the obligations under the TBT Agreement, the representative of Turkey noted 
that the available scientific and safety information and intended end-use of borates did not indicate 
that, should the objective not be fulfilled, it would cr eate a risk.  It was his delegation's understanding 
that  the classification decision did not have a legitimate objective and in fact created unnecessary 
obstacles to trade and violated the TBT Agreemen t.  He invited the European Communities to 
consider Turkey's and other Member s' concerns before taking any further steps in the application of 
this measure. 
90. The representative of Argentina  associated his delegation with the comments made by 
previous speakers, especially with respect to th e possible impact on industry and in particular 
cosmetic industry. 
91. The representative of Indonesia  echoed the concerns voiced by previous delegations, 
including those set out in the joint letter sent to the European Communities on 12 March 2008, as 
explained by Canada. 
92. The representative of Japan  shared the views of previous sp eakers, and the delegation of Cuba 
in particular.  He appreciated the decision of the European Communities to notify the 31st ATP. 
93. The representative of Colombia  associated his delegation with comments made by previous 
speakers.  The reply provided by the European  Communities to the comments made was being 
reviewed and Colombia would revert to the matter in the near future. 
94. The representative of Malaysia  reiterated the concerns expressed by his delegation in previous 
meetings.  In particular, it was his delegation's view  that the EC measure seemed to be based more on 
the precautionary principle than on sound scientific  evidence.  While the EC response to the 
comments made was appreciated, it did not give e nough assurance about the potential adverse effects 
of the measure.  Malaysia was of the view that the proposal was more trade -restrictive than necessary 
and therefore not in line with Article 2.2 of the TBT Agreement.  The measure would result in trade 
restrictions and would, in turn, impair his country's  ability to market its products, in particular rubber 
from wood treated with borates, one of  Malaysia's major export items.  On behalf of his delegation, he 
urged the EC to reconsider its classification of borates as Category 2. 
95. The representative of Zimbabwe  shared the concerns expressed by previous delegations. 
96. The representative of Cuba, speaking of behalf of ACP group , noted that the president of the 
ACP group in Brussels had sent a letter to DG Envi ronment of the European Commission in which it 
was explained that if the draft 30th and 31st ATPs were applied as proposed, the directives could 
constitute a threat to exports of nickel-based subs tances for ACP countries to the European Union.  
Additionally, if classified as proposed, the use of nickel substances would be restricted under REACH 
and would therefore constitute a barrier to trade.  ACP countries and other developing countries were 
still trying to understand and implement REACH, wh ich was already causing them difficulties.  He 
stressed that more time was needed to gain a co mprehensive understanding of this issue and that the 
European Communities should refrain from taking any further action.   
97. The representative of Chile , referring to the proposed classification of borates, highlighted 
that the level of exposure in a mine was not repr esentative of "normal handling and use" for products 
containing borates, and that the studies in mines ha d not concluded that there were adverse affects 
from exposure to borates.  There were results of te sts carried out in China on more than 1000 workers G/TBT/M/44 
Page 18  
 
  exposed to borates, where no adverse affects had been  noted.  She was also concerned with the direct 
relation between the directive and REACH. 
98. The representative of the Philippines
 shared the views expressed by Canada, Australia, Cuba 
and others and recommended the European Communities not to take any further step with respect to 
the 30th ATP. 
99. The representative of the European Communities , in reply to some of the questions raised and 
starting with concerns on borates, noted that his de legation did not agree with the analysis made by 
Turkey that it was not possible for humans to in take enough quantities of borates for them to have 
adverse effects.  In particular, the evaluation done by the EC scientific committee on cosmetic 
products concluded that a threshold was needed to  limit the amounts of borates in cosmetic products 
in order to avoid adverse affects on human health.  A limit value had to be set for borates in food for 
the same reason.  While he appreciated the work ca rried out by Turkey on human studies, he stressed 
that it was a very complex scientific exercise to prove  a negative.  Factors such as the effects on future 
generations, for instance effects on children whose parents had been exposed to borates, had to be 
taken into account and were difficult to assess.   
100. Moving on to nickel, the representative of th e European Communities stressed that in the 
Communities, the precautionary principle was invoked as a risk management tool after a risk assessment had been conducted.  In the case of th e classification and labelling of these substances, the 
precautionary principle had not been applied, as classification and labelling was a hazard-based 
approach, where information on risk and use were  considered in very specific conditions and 
circumstances but not within a trad itional risk assessment context.  Therefore, there was no basis to 
invoke the precautionary principle.  Indeed, the directive stated that the purpose of classification and 
labelling was a hazard assessment, and that the crite ria of "normal handling and use" in the annex 
needed to be considered in that context.  
101. On the connection with REACH, the representa tive of the European Communities stressed 
that there was no automatic link between aut horization in REACH and the classification of 
substances.  He also emphasized that not all the identified substances under REACH should undergo 
authorization.  Article 58 of REACH clearly stated the circumstances in which a substance was a candidate for authorization. 
102. On the 30
th ATP and how to treat new data, the representative of the European Communities 
said that new studies on substances were produced re gularly; these were dealt with in the following 
way:  once a threshold of information to move forward was achieved, a decision was made.  The 
decision would then be adjusted in light of sub sequent new information or studies which proved that 
the decision was incorrect.  He added that, if new information from industry was forthcoming, this 
would be examined as a matter of urgency. 
103. Regarding the comment on the classification of all nickel compounds as carcinogenic, the 
representative of the European Communities clarified that the 31st ATP Directive would clearly 
differentiate between the nickel compounds consider ed to be carcinogens from those that were not, 
and that not all nickel compounds needed to be cla ssified.  He stressed that it was too difficult to 
determine whether nickel was a carcinogen in anim als.  For example, epidemiological studies had 
shown that nickel ion was carcinogenic in humans.  However, nickel ion tests on animals had not 
shown that this was so clearly the case for animals.  Therefore, the likelihood  that tests on animals 
would show the cancerogenity of nickel in huma ns was small.  Testing requirements under REACH 
were not likely to resolve this issue because they would be much lower than what was necessary to 
prove or disprove the carcinogenicity of these compounds.  G/TBT/M/44 
 Page 19 
 
 
  104. On the OECD study, the representative of the European Communities fully concurred with 
the fact that it was an initial asse ssment.  However, he stressed that the methodology applied by the 
Communities for grouping these compounds, in particular nickel carbonate, had been reviewed by OECD experts and that there had not been any signi ficant criticism as to the approach applied.  The 
word "draft" meant that it was an initial assessment profile which had not yet been endorsed by the 
joint meeting of the OECD.  He also clarified that the OECD guideline on groupings had not been 
applied, in particular the last two steps, calling for confirmatory testing, which meant that further 
animal tests had to be carried out.  Instead, when such confirmatory testing was required to confirm 
that a classification was necessar y, the European Communities had chosen the approach of not 
classifying at all. 
105. On cosmetics, the representative of the Eur opean Communities stressed  that the cosmetic 
directive on boric acid would have no immediate consequences for para-borates.  The process that would be followed was to consult the scientific co mmittee for cosmetic products about the risk posed 
by the use of these substances and, if a ri sk was found, what the limit value should be. 
106. The representative of Canada
 sought clarification on the timing of notification of the 31st 
ATP.  Would this be notified to the TBT Committee only after the directive had been approved by EC 
member States? 
107. The representative of Turkey  stressed that his country produced around 70 per cent of known 
borates, and that no adverse effect had been ob served in humans.  Additionally, setting limit values 
for borates in food did not mean that the substa nce was toxic under "normal handling and use".  
108. The representative of the European Communities  explained that a notification would be made 
after the inter-service consultation process at the EC level was concluded.  He  also pointed out that 
the timing for the 30th and 31st ATP directives would also have an effect on Annex 6 of the 
Classification, Labelling and Packaging Regulation (CLAP), which was undergoing the co-decision procedure at the EC level.  In concluding, he informed the Committ ee that all the background material 
and studies on which the Community had based its  classification and labelling for all the compounds 
in the 30
th and the 31st ATPs and the minutes of all the delibera tions were available on the website of 
the European Chemicals Bureau.7 
(ii) European Communities - Regulation on the Regi stration, Evaluation and Authorisation of 
Chemicals (REACH) (G/TBT/N/EEC/52, Add. 1-4 and Add.3/Rev.1) 
109. The representative of Argentina  reiterated his delegation's pos ition that REACH could distort 
global trade in chemicals and chemical products.8  It was his delegation's understanding that there 
could be a lack of uniformity in the application of  REACH by EC member States, given the different 
levels of development, structures and different implementation bodies.  Of particular concern was the 
"single representative" clause in the regulation, whic h could lead to an unequal treatment between EC 
and non-EC companies.  
110. Additional difficulties were also related to th e product registration process in REACH, where 
industry was responsible for the conformity process of  more than 30,000 substances, even when there 
did not seem to be a risk indication associated w ith many of them.  The only competent body for 
conformity registration was in the European Comm unities, which made it more onerous for industries 
outside the EC.  REACH was also very complex and difficult to understand.  This was compounded 
by the delay in technical assistance granted by th e Communities to companies outside the EC.  As far 
as amendments to the regulation were concerned,  the representative of Argentina expressed his 
                                                      
7http://ecb.jrc.it/  
8A communication from Argentina was subsequently circulated (G/TBT/W/286).  G/TBT/M/44 
Page 20  
 
  delegation's request that the EC notify all devel opments to the Committee so  that the comments from 
Members could be taken into account. 
111. The representative of the United States
 noted that his delegation supported the objectives of 
protecting health and the environment.  However,  concerns remained that the REACH regulation 
appeared to be overly broad and to adopt a partic ularly costly, burdensome, and complex approach 
that could disrupt and distort global trade.  The Un ited States continued to study the regulation and its 
potential trade impact and was closely monitoring th e implementation process.  He recalled that at 
least twenty WTO Members, and a large number of  stakeholders, both large and small and from a 
variety of industry sectors, continued to raise ser ious questions and concerns regarding REACH and 
its implementation.   
112. In particular, concerns related to the followi ng issues: a continued uncertainty regarding the 
scope and applicability of the provisions relating to articles;  the need for non-EC manufacturers to 
register reacted monomers in polymers;  placing s ubstances on the authorization candidate list when 
an assessment of risk had not been undertaken, par ticularly considering the chilling effect that the 
placement on the list was likely to have;  potentia l preferential treatment for "existing substances" 
manufactured in the European Communities as compar ed to existing substances manufactured outside 
the European Communities - in terms of whether these substances (e.g., cosmetics) qualified as 
"phase-in substances";  the lack of transparency  in the development of the REACH Implementation 
Projects (RIPs);  the potential for differential enfo rcement of REACH across the EC member States, 
including the treatment of articles;  the protection of business proprietary information required for registration with respect to different entities in  the supply chain and in Substance Information 
Exchange Fora (SIEFs);  fees and others costs as sociated with REACH;  the operation of the "only 
representative" provision; and REACH’s potentially disproportionate impact on small and medium 
size enterprises (SMEs).   
113. With respect to the implementation of REACH,  the representative of the United States urged 
the European Communities to take in to consideration the concerns wh ich had been registered by its 
trading partners and other interested parties, and to ensure a meaningful opportunity to reflect the 
views of other governments and stakeholders in the process.  He stressed that discussions between EC 
technical experts and their counterparts in the Unite d States and other countries would continue in the 
TBT Committee process and thr ough bilateral channels.   
114. With respect to transparency, the representative of the United St ates noted that the European 
Communities had been developing guidance docum ents, the so-called REACH Implementation 
Projects (RIPs).  Forthcoming documents woul d address critical issues such as the "only 
representative" and the authorization candidate lis t.  Industry, especially small and medium size 
enterprises, was having particular difficulties monitoring these guidance documents, given their 
volume, complexity, and ambiguity on many issues.  The representative of the United States urged the 
European Communities to provide a meaningful op portunity for governments and stakeholders to 
comment on each proposed RIP document. 
115. On the provisions regarding the "only represen tative", the representative of the United States 
pointed out that REACH required each EC manufact urer or importer of a substance, or article 
containing a substance, to register that substance.  This meant that if a non-EC manufacturer relied on 
multiple EC importers to export its substance or article to the Europ ean Union, each importer had to 
separately register the substance or article, while  companies established in the European Union could 
register substances or articles on their own behalf.  To reduce the significant burden this would entail 
with respect to imported products, companies that were not established in the European Union could 
appoint an "only representative" to register their substances.  However, the representative of the 
United States highlighted that, according to industry,  the benefit of the "only representative" provision 
was undermined on account of its potential to disrup t global supply chains, especially SMEs within  G/TBT/M/44 
 Page 21 
 
 
  those supply chains, and to allow for potentiall y discriminatory treatment between EC and non-EC 
actors.   
116. In particular, one of the primary questions raised by companies was whether the "only 
representative" appointed by a non-EC manufacturer c ould register on behalf of all EC importers of 
the monomer or additive produced by that manufacturer.  With only a few months to go before pre-
registration began, the answer to this question was unclear in the new RIP 3.1 on registration.  While 
REACH appeared to allow for all non-EC manufact urers, formulators, and article producers to 
appoint an "only representative" to register the s ubstances they produced (or that were contained in 
articles), industry in the United States was still unclear as to whether non-EC manufacturers, 
formulators, or article producers who did not directly export to the European Union would be able to 
appoint an "only representative".  If such limitation existed, companies that did not directly export 
their substances to the European Union would fi nd themselves in the position of having to disclose 
business proprietary information to downstream users in their supply chain that could register the substance.  Such a limitation could restrict trad e because many companies would refuse to disclose 
such information within their supply chains, which would prevent their products from being sold in 
the European market. 
117. Moreover, the representative of the United St ates stressed that not allowing substance 
producers who were not direct exporters to th e European Communities to appoint an "only 
representative" would also be inefficient.  A subs tance producer could sell to several dozen non-EC 
companies, all of whom ultimately exported to th e European Communities.  Rather than each of the 
individual exporters having to appoi nt an "only representative" to register the substance, it would be 
more efficient to permit the underlying substance pr oducer to appoint a single "only representative" to 
handle the registration process for the relevant substances it produced.    
118. The European Chemical Agency (ECHA) should provide complete, stand alone guidance on 
the issue of the "only representative" that was clear , took into account concerns and questions raised 
by stakeholders, and ensured that the operation of the "only representati ve" provision did not 
discriminate between foreign and domes tic suppliers or otherwise distor t trade.  In particular, non-EC 
substance manufacturers should be allowed to appoint  an "only representative" regardless of whether 
they directly exported their substance to the Europe an Union.  This would help ensure that non-EC 
substance manufacturers were put in a similar pos ition to an EC-substance manufacturer and would 
allow the non-EC substance producer to know that its  information was being reported correctly and to 
avoid sharing confidential information with downstr eam users.  Providing such guidance would also 
create a more conducive environment for the deve lopment of "only representative" services.   
119. On the registration requirements for reacted mono mers in polymers, the representative of the 
United States recalled that REACH exempted polymer s from registration and evaluation, as they were 
generally believed to cause minimal risk.  Ye t REACH required manufacturers or importers of 
polymers to register reacted monomers, which we re chemically bound within polymers.  However 
monomers, once reacted, no longer existed as indivi dual substances in polymers, thus rendering the 
possibility of exposure to be minimal.  The react ed monomer registration requirement provided an 
incentive for distributors to switch to EC polymer suppliers, since the monomers in those polymers 
would already have been registered, thus avoi ding the registration requirement.  Many non-EC 
polymer manufacturers would be unwilling to provid e the necessary information to importers due to 
confidentiality concerns, or because it would be too burdensome to obtain this information, or not 
economically feasible to register their monomers th emselves due to the high registration fees.   
120. 
The requirement to register reacted monomers further complicated the operation of the "only 
representative" mechanism, since it increased the numb er of substances that needed to be registered 
and the number of actors involved.  The representati ve of the United States encouraged the European 
Communities to set out the scientific and technical  information it relied upon in determining that G/TBT/M/44 
Page 22  
 
  reacted monomers in polymers needed to be register ed, particularly in light of its conclusion that 
polymers themselves did not have to be registered on account of the minimal risks associated with them.   
121. With respect to the effect of placing subs tances on the authorization candidate list, the 
representative of the United States noted that the Eu ropean Chemical Agency (ECHA) was expected 
to issue a candidate list of those substances that w ould be subject to authorization on account of them 
potentially being substances of high concern.  His delegation remained concerned that this list was 
hazard-based, where substances would be placed on the candidate list without evidence that the 
substances posed a risk in particular concentrati ons or for particular e nd-uses and channels of 
exposure, and without information on the risks to c onsumers of using an alternative substance.    
122. Moreover, it was pointed out that the evaluati on of all the chemicals on the candidate list 
could take decades, and that the status of such ch emicals would remain uncertain for the foreseeable 
future.  In light of the significant additional re porting requirements associated with using substances 
subject to authorization and the potential restrictions on their use, many companies believed the candidate list of substances for authorization woul d be used as a "black list," causing companies to 
discontinue using substances on the list before th e ECHA had evaluated the information necessary to 
determine whether the substance posed a risk.  If pu rchasers demanded products free of candidate list 
substances, product suppliers could find themselve s obliged to undertake costly reformulations, 
despite the lack of science justifyi ng such a change.  In addition, such a change could result in the use 
of relatively untested chemicals whose environmental,  public health, or consumer safety impacts were 
unknown and potentially harmful.   
123. To reduce a potential "black list" effect in  the development of the candidate list and 
unnecessary substitution of known chemicals for s ub-optimal or untested  alternatives, the 
representative of the United States expressed his delega tion's request to the EC to provide guidance on 
the status and purpose of the candidate list prior to and coincident with the publication of the 
candidate list and candidate substa nce dossiers.  The EC was also requested to proceed with the 
publication of the candidate list only when such guida nce had been notified to the WTO, and that any 
comments received had been taken into account. 
124. The European Communities were also encouraged  to make clear that: (i) only substances on 
the final authorization list would be subject to aut horization and related restrictions, (ii) that the 
ECHA would evaluate use-based risk assessment in formation to determine which substances would 
be subject to authorization; (iii) that producers should not use the inclus ion of a substance on the 
candidate list as a reason not to use that substan ce, or to use a substitute for it; and (iv) that 
substitution or reformulation could exacerbate negati ve environmental, health, or safety concerns as 
the risks associated with substitutes might not be known.    
125. The representative of the United States furthe r encouraged the European Communities to 
explain how stakeholders could provide ECHA and the European Commission with comments on 
substances nominated for inclusion on the candida te list, and how ECHA and the Commission would 
take such comments into account.  In addition, once a decision had b een made to add a substance to 
the candidate list, a decision support document shoul d be provided at the time that the candidate list 
was released. 
126. With respect to the burden on SMEs, the repr esentative of the United States stressed that 
REACH placed a significant communication burden on gl obal supply chains.  Faced with the task of 
obtaining all of the necessary data to comply with REACH, many manufacturers were requesting each 
of their upstream substance suppliers to provide them with information required to register the 
manufacturers’ products, or the substances they contai ned.  As a result, substance manufacturers were 
facing enormous data requests, including for busin ess-sensitive information.  Many SMEs, who were  G/TBT/M/44 
 Page 23 
 
 
  engaged in selling their products domestically, did no t have the resources or the ability to discern the 
data necessary to ensure complete and accurate registration under REACH.   
127. It was further highlighted that burdens would be especially acute for many small and medium 
sized enterprises, in both developed and developi ng countries.  Unlike large multinationals, SMEs 
would be less likely to have a European presence a nd, therefore, would effectively have little choice 
but to appoint an "only representative" to register their products.  If several manufacturers of the same 
substance appointed a single "only representative" to  register the substance, the tonnage of the 
substance exported to the European Union by each manufacturer would be aggregated.  The aggregate 
tonnage of a substance registered by a single " only representative" would then be the basis for 
determining fees and registration requirements.  Su ch aggregation of tonnage could result in higher 
fees and trigger the requirement to submit a Chemic al Safety Report when lower fees or no Chemical 
Safety Report would otherwise be required.  Indust ry reported that registration and testing fees could 
easily exceed US $50,000 per substance; if a pa rticular company used 50 substances in its 
preparations and articles, the cost could be prohibitive.    
128. In concluding, the representative of the Unite d States stressed that many SMEs could not 
afford to re-tool, or set up separate, production li nes for substances, preparations, and articles bound 
for the EC market.  In some cases, they might not know where their products would ultimately be shipped.  As a result, many companies that did no t themselves export to the EC market could find 
themselves in the situation of having to ensure th at their products, or substances in their products, 
were registered.   
129. The representative of Chinese Taipei
 echoed the concerns raised on REACH.  In particular, 
questions remained on the way REACH was going to be implemented.  In areas such as the 
availability of guidance on pre-registration, regi stration fees and penalties for non-compliance, access 
to detailed information was essential.  He requested  that the European Comm unities fully take into 
account the principle of transparency in order to  avoid possible technical trade barriers for third 
countries.  Of particular concern was also the c onfidentiality of registration documents submitted by 
manufacturers located in third countries.  This  process had to be carried out by an "only 
representative" located in the Eur opean Communities.  Therefore, his delegation was of the opinion 
that ECHA should provide a list of "only representa tives" registered in th e European Communities 
that had received adequate training in confidentialit y, and that it should monitor their operations so as 
to ensure that confidential documents were duly protected during the registration process. 
130. The representatives of Australia  and Brazil  shared many of the concerns raised by previous 
speakers.  Australia in particular was concerned about transparency and the impact of REACH on 
non-EC producers. 
131. The representative of China  stressed that REACH was a complex regulation and that 
industries, especially SMEs, in developing co untries like China faced big challenges and many 
difficulties in complying with it.  Chinese industrie s were particularly concerned about the complex 
registration procedures and the associated high fees.  REACH would also bring about restrictions on 
trade in downstream industries due to its broad approach.  Additionally, enterprises outside the 
European Communities could not conduct registration, which raised concerns that they would not be treated equally and fairly.  His delegation was also  concerned about whether EC member States would 
apply REACH in a uniform and cons istent manner.  China was also interested in presenting comments 
on the REACH Implementation Projects (RIPs).   
132. The representative of Chile
 noted that industry in her country was particularly interested in 
receiving technical assistance from European experts,  so that REACH could be better understood and 
applied, especially in light of th e upcoming pre-registration period, starting on 1 June 2008.  Concerns 
remained about the possible differences of interpretation among different EC member States with G/TBT/M/44 
Page 24  
 
  respect to the application of REACH on different articles.  The practical implementation of REACH 
would be very complex and difficult to monitor and th is would affect fair competition in the European 
market and generate discrimination. 
133. The representative of Cuba
 shared the concerns expressed by previous delegations, in 
particular Argentina.  His delegation believed that REACH could create difficulties for Cuba and 
other developing countries' exports to the EC market .  He informed the Committee that, as a result of 
the ILAC Mutual Recognition Arrangement signed by  Cuba in 2005, the reliability of results of 
Cuba's accredited laboratories was recognized.  Ho wever, in the Cuban accreditation system, there 
was a limited number of accredited laboratories and only in some specific types of chemicals, 
physical-chemicals, electrical, radiological and corrosion tests.  Time was needed to accredit further 
laboratories in accordance with the provisions of RE ACH.  On behalf of his delegation he requested 
that the European Communities postp one the entry into force of REACH, in particular in light of 
Article 12.3 of the TBT Agreement which provided th at all Members needed to take into account the 
special development and trade needs of developing  countries in preparing and applying technical 
regulations. 
134. With respect to the fact that REACH did not recognize the results of national certification 
bodies and of test laboratories in countries outside the European Communities,  the representative of 
Cuba stressed that Article 6 of the TBT Agreem ent provided that Members should ensure, to the 
extent possible, that results of conformity assessme nt procedures carried out by other Members were 
accepted.  Additionally, various mutual recogniti on agreements and voluntary arrangements provided 
that regional accreditation bodies and internati onal accreditation structures should be mutually 
recognized, and that the results of test laborator ies should be also be recognized.  His delegation 
believed that there was no justification for only r ecognizing the results of test carried out by EC 
laboratories as provided under REACH.  
135. The representative of Thailand  referred to her delegation's previously expressed position on 
REACH.  While Thailand supported the objectives of the protection of human health and the 
environment, the complexity of REACH was si mply beyond the capacity of many developing and 
least developed countries.  SMEs, in particular , would not have the capabilities to understand the 
complexity of the regulation, or overcome the severe difficulties in complying with it. 
136. The representative of Korea  appreciated the efforts made by the European Communities to 
accommodate his delegation's concerns.  However, SM Es had difficulties in complying with REACH.  
More active consultation and information dissemina tion activities were necessary with stakeholders 
outside the European Communities, including training programmes.   
137. The representative of Japan  raised some specific questions concerning REACH.  First, he 
noted that the guidance about the registration for the implementation of REACH (February 2008) stipulated that the "only representative" could re present one or several non-EC manufacturers. As the 
"only representative" was fulfilling the registrati on obligations of importers, the tonnage of the 
substance to be registered was the total of th e tonnages of the same substance covered by the 
contractual agreements between the "only repr esentative" and all non-EC manufacturers represented 
by him. 
138. However, aggregating the volumes imported from different non-EC companies could cause 
the total tonnage to exceed the thresholds for th e requirements under REACH, even if the volume of 
each single non-EC manufacturer contracted to the " only representative" was below the threshold.  EC 
manufacturers did not face the risk of their tonnage being aggregated with those of other manufactures 
with the result that the total exceeded a given th reshold for REACH requirements.  Consequently, 
Japan was concerned that aggregating the volumes c ontracted by an "only representative" could pose 
discriminatory and excessive burdens for non-EC manufacturers.  G/TBT/M/44 
 Page 25 
 
 
  139. Secondly, the representative of Japan sought clarification on whether substance manufacturers 
who did not directly export to the European Co mmunities but were upstream from other businesses 
could also appoint and register their substance th rough the "only representative".  Thirdly, he noted 
that, according to Article 33 of REACH "Duty to Communicate Information on Substances in Articles", suppliers of articles were to provide c onsumers with information concerning substances of 
very high concern on request by the consumer and with in 45 days of receipt of the request.  However, 
depending on the article or substa nce, suppliers could find themselves needing to inquire from other 
suppliers in the upper supply chain.  In that case,  it would be impossible to provide the relevant 
information at such short notice if adequate info rmation was not provided by the upstream suppliers.  
He sought clarification on the effective burden for the suppliers in this regard which, in his 
delegation's view, Article 33 of REACH did not sufficiently clarify. 
140. Finally, under REACH, an importer of polymers into the European Communities was 
requested to register the constituent monomers of the polymers from outside the European 
Communities.  In such cases, there could be pr oblems related to possible leakage of data to 
manufacturing competitors.  In contrast, in the Eu ropean Communities, the monomers were registered 
directly by the monomer producers and the polym ers manufacturers in the European Communities 
were not requested to register the composite of monomers.  Therefore, information on their 
composition did not have to be shared with competit ors.  Japan was concerned that this difference in 
the registration process could lead to a disadvantag e for polymer manufacturers outside the European 
Communities, thereby constituting a barrier to tr ade.  A similar issue existed in the case of 
preparations and their constituent substances a nd the representative of Japan expressed his 
delegation's appreciation for the efforts made by the European Communities to clarify the situation 
both bilaterally and multilaterally. 
141. The representative of South Africa
 pointed out that industry in his country was of the opinion 
that REACH was very complex legislation and that it was difficult to interpre t what was expected of 
them.  He requested the European Communities to al low more time for industry to become acquainted 
with the provisions of REACH.   
142. The representative of the European Communities  pointed out that the obligation to register 
under REACH would enter into force on 1 June 2008 .  He informed the Committee that a workshop 
on REACH would be held in Brussels in April 2008.9  He noted that many of the concerns raised were 
related to the "only representative".  For example,  on the issue of the accumulation of tonnages when 
one "only representative" represented non-Community ma nufacturers, he stressed that information on 
this point was contained in the guidance document on registration10.  The Commission and the 
European Chemicals Agency were eager to ensure that guidelines provided to stakeholders contained 
the necessary and appropriate information.  If this  was not the case, the guidelines could be revised. 
143. On whether the non-EC manufacturers who di d not export directly to the European 
Communities were allowed to appoint an "only re presentative", the representa tive of the European 
Communities explained that the issue was being ex amined and the outcome of these examinations 
would be made available on the website of th e European Chemicals Agency in due course.11  On the 
question raised by Japan regarding the interpreta tion and the scope of article 33 of REACH, he 
stressed that the information to be provided only co ncerned substances in the list set out in accordance 
with Article 59(1) of REACH (Annex XIV, "candidate  list").  Article 33 stated that the information 
which was available to the supplie r had to be given upon request to the consumer, and at least the 
                                                      
9Information about the REACH Workshop can be found at: 
http://ec.europa.eu/enterpri se/reach/events_en.htm#video  
10  The guidance has subsequently been updated, see 
http://reach.jrc.it/docs/ guidance_document/r egistration_en.htm  
11 http://echa.europa.eu/  G/TBT/M/44 
Page 26  
 
  name of the substance.  Therefore, the obliga tion for the supplier was to have available the 
information regarding the name of the substance in the candidate list.   
144. On the issue of monomers in polymers, th e representative of the European Communities 
noted that the relevant guidance for stakeholders  and economic operators to follow was available on 
the ECHA website.  However, he informed the Comm ittee that a question on the interpretation of this 
provision had recently been submitted to the European Court of Justice.
12 
145. On the issue of uniform interpretation across the European Communities, the EC 
representative recalled that the legal instrument chosen for REACH was a regulation, which was 
directly applicable to all member States.  Th e European Commission w as closely examining and 
following the coherent and consistent  application throughout the 27 EC member States.   Furthermore, 
helpdesks had been established both at the ECHA and in several EC member States, which would 
further contribute to the coherent and consistent implementation of RE ACH, as well as being a useful 
tool for interested parties to obtain information.   
146. The representative of the European Communities fu rther highlighted that  the various guidance 
documents were available on the websites of the Eu ropean Chemicals Agency and the European Joint 
Research Centre13, which advised the Commission on scientific issues.  These documents were not 
mandatory, nor did they contain specifications for products.  Therefore, they did not need to be notified under the TBT Agreement.  On the issue of recognition of laboratories raised by Cuba, the representative of the European Communities stressed that tests of laboratories which complied with 
the OECD guidelines on good laboratory practices would be recognized.   
147. It was also noted that the European Commission had drafted a regulation, concerning fees and 
charges payable to the European Ch emicals Agency. This regulation, expected to be adopted in April 
2008 and communicated to the Members upon its adoption
14, implemented articles 74 and 132 of 
REACH.  These two provisions already laid down the circumstances under which fees or charges might be levied, as well as the principles that had to  be applied to fix the level of fees and charges.  
According to the draft regulation, there would be fees for the registration and fees for the 
authorization processes.  The level of fees would be related to workload: for example, the level of the 
fee for registration varied according to the tonna ge, and reductions applied in the case of joint 
submissions.  A lower registration fee had also been fixed for the registration of intermediates, as the 
associated workload would be lower than  for other registration dossiers.   
148. The basic authorization fee covered one appli cant, one substance and one use.  Additional 
fees would be applied in the case of applications c overing more than one applicant or more than one 
substance or more than one use.  The agency could also levy ch arges for services that were not 
specifically subject to the payment of fees, in particular  with respect to the review of an authorization.  
The level of fees and charges had been fixed taking into account a substantial contribution of the EC 
budget to the total cost of the Agency.  Reducti ons would apply to micro, small and medium 
enterprises in the range between 90 per cent and 30 per cent.   
149. The representative of the European Commun ities invited Members which had shown an 
interest in receiving technical assistance, to direct  their requests to the respective delegations of the 
European Commission in their territory.  The request s would be examined also in light of whether 
they could be met by existing technical assistance  programmes or whether further assistance would be 
needed.  Finally, the representative of the European  Communities stressed that the principles of non-
discrimination and avoidance of unnecessary obstacles to trade had been taken fully into account in 
                                                     
 
12 Case C-558-07 
13 http://ecb.jrc.it/reach/  
14 See G/TBT/N/EEC/52/Add.5.  G/TBT/M/44 
 Page 27 
 
 
  the development of REACH, and that the authori zation and registration requirements were not overly 
restrictive and were workable in practice.  
(iii) Norway – Proposed regulation concerning sp ecific hazardous substances in consumer 
products (G/TBT/N/NOR/17)  
150. The representative of Norway  informed the Committee that the above-mentioned regulation 
had not entered into force on 1 January 2008 as prev iously announced and that comments received in 
a public hearing were being evaluated by Norwegia n environmental authorities.  In this hearing 
process, useful information concerning the appli cation of some of the substances covered by the 
proposed measure had been received.  The Norweg ian environmental authorities were also holding 
meetings with interested stakeholders.  Limit values for the different substances and possible 
exemptions were being evaluated, with the aim of finalizing a decision by the end of 2008.   
151. The representative of the United States  thanked Norway for the update and highlighted that 
his delegation would continue to monitor the issue closely.  
152. The representative of Korea  appreciated the fact that the re gulation had not entered into force 
and believed that the measure could create obstacles to  trade.  More scientific analysis needed to be 
conducted before the measure could enter into force.  
153. The representative of Israel  pointed out that his delegation would monitor the issue closely, 
especially with respect to th e two chemicals of export interest to his country, namely: 
tetrabromobisphenol A  (TBBPA) and hexabromocyclododecane  (HBCDD). 
154. The representative of Jordan  thanked Norway for the update and stressed that his delegation 
would welcome any technical consultations with the relevant Norwegian authorities, also with respect 
to the two chemical substances of interest to his country: TBBPA and HBCDD. 
(iv) European Communities -  Directive 2002/95/EC on  the Restriction of the Use of certain 
Hazardous Substances in Electrical and Electronic Equipment (RoHS) 
155. The representative of the United States  drew the Committee's attention to the EC's on-going 
review of its directive on the restrictions of h azardous substances and recalled that several discussions 
had taken place in the Committee dur ing the development and initial im plementation of this directive, 
including problems related to the lack of clear guida nce and transparency.  He noted that the results of 
a recent study by a global association of electroni cs companies showed that  initial compliance cost 
associated with the original RoHS directive wa s US$32 billion.  The study showed that smaller 
companies had devoted a significantly larger percen tage of total revenues to RoHS compliance than 
larger companies – up to 6 per cent of revenu es for companies with annual revenues of US$5-10 
million and significantly less than 1 per cent for companies with revenues of over US$1 billion per 
year.   
156. The representative of the United States emphasi zed that, given the costs of compliance and 
the disproportionate impact on SMEs, EC regulator s should ensure a risk a nd science-based approach 
to evaluating whether to add additional substances to the list, to broadening the scope of application, 
and to setting maximum concentration levels for specific products.  The Eu ropean Communities were 
also encouraged to provide clarity on how RoHS and REACH would fit together and to carry out a transparent process, including a notification to the WTO of proposed changes or amendments to 
RoHS, allowing a meaningful opportunity for comment by all interested stakeholders. 
157. The representative of the European Communities
 confirmed that the RoHS directive was 
being reviewed.  The objectives of this review were  twofold: first, to present proposals for the G/TBT/M/44 
Page 28  
 
  inclusion of medical instruments and control a nd monitoring equipment within the scope of the 
directive, as well as to examine the feasibility of extending the ban to other hazardous substances.  
Second, to simplify the provisions of the directive with the aim of making RoHS easier to apply and to address reported implementation difficulties.  Sh e recalled that the review had started with a 
consultation period with interested stakeholders , who could submit comments and provide relevant 
information, between March and May 2007.  More consultations, se tting out concrete policy options, 
had been terminated in February 2008.  Many  companies and associations from third countries, 
including from the United States, had contributed  extensively to the consultation process.   
158. The representative of the European Communities further highlighted that several studies had 
been initiated.  A first study was related to the inclusion of medical devices as well as monitoring and 
control instruments within the scope of the dir ective.  Another study covered the innovation and 
competitive aspects of the RoHS review.  Additi onally, two on-going studies were examining the 
need and possibilities of extending the ban to othe r substances and the exemptions which were 
granted under the RoHS directive.  An impact assess ment was also underway and was expected to be 
concluded in early July.  This would lead to the preparation of a proposal by the Commission which 
would be tentatively adopted or proposed in Septem ber.  The proposal would be notified to the TBT 
Committee at a draft stage with the possibility to s ubmit comments.  She informed the Committee that 
the results of the two consultations as well as inform ation on the studies were available on the website 
of the DG Environment of the European Commission.
15   
(v) Argentina – Measures affecting market a ccess for pharmaceutical products (G/TBT/W/280) 
159. The representative of Colombia  recalled that at the previous meeting of the Committee, his 
delegation had expressed concerns relating to the system applied by Argentina for the entry of 
pharmaceuticals into its market, specifically with regard to the classification of countries and the 
resulting application of conformity assessment procedures.  Concerns had also been raised with respect to the classification and application of tari ffs or fees for undertaking verification visits to 
plants located in the countries of origin of the pharm aceuticals.  It was his delegation's view that some 
of the measures were contrary to the rights and obl igations under the TBT Agreement, in particular 
those related to the principle of national treatment and transparency.  He pointed out that no reply had 
been provided by Argentina on the concerns express ed, and sought clarification on whether Argentina 
had revised the document submitted whic h listed the concerns in detail. 
160. The representative of Chile
 recalled that her delegation had also expressed concerns on this 
issue.  She noted that, in spite of the fact that Chile was included in the list of countries whose 
sanitary and pharmaceutical systems were considered reliable by Argentina, Chilean pharmaceutical 
products had been denied access to the Argentinean market.  Chile had also invited Argentina to visit 
its facilities.  She asked Argentina to take these concerns into account and to take the necessary steps 
to solve this problem. 
161. The representative of Paraguay  noted that concerns had been  expressed by his delegation on 
these measures in a regional context in May 20 07, and that no progress had been made.  His 
delegation shared the concerns expressed by Colomb ia and Chile, and was waiting for a review to 
take place concerning visits, fees and registration to export to the Argentinean market  
162. The representative of Argentina  noted that the document was being analyzed in capital and 
that the issue could be addressed through bilateral channels. 
                                                      
15 http://ec.europa.eu/environment/index_en.htm   G/TBT/M/44 
 Page 29 
 
 
  (vi) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203) 
163. The representative of New Zealand  recalled that concerns about Canada's regulation 
governing compositional requirements for cheese had been  expressed by his delegation at the July and 
November 2007 meetings of the Committee.  Despite the bilateral consultations  held with Canada, his 
delegation remained of the view that the new regul ations were overly restrictive in nature, both in 
terms of their allowance for the us e of dairy ingredients and their impact on trade.  The regulations 
limited the use of protein sourced from dairy ingred ients such as skimmed milk powder.  However, 
such ingredients were widely used and accepted in many countries.  The bulk of these ingredients in 
Canada were imported and the regulations were placing new rest rictions on the domestic market for 
these products. 
164. In particular, the representative of New Zealand sought clarification on whether Canada had 
considered any other options in developing the re gulations; on the rationale for adopting regulations 
that set forth quantitative restrictions on ingredient s used in cheese that were  inconsistent with the 
Codex approach towards cheese standards; and, on  whether it intended to extend the approach of 
establishing restrictive compositional standards to other dairy products, such as yoghurt. 
165. The representative of Australia  reiterated his delegation's con cerns about the new regulations 
on compositional standards for cheese  and was disappointed that the regulations had been adopted and 
would come into effect in December 2008.  His delegation believed that th e measures were more 
trade-restrictive than necessary and discriminated agai nst products such as milk protein concentrates, 
skimmed milk powders and whey protein concentrat es, which were mainly imported into Canada.  
His delegation was also concerned that the regul ations deviated substantially from Codex cheese 
standards.  Canada had offered no justification as to why Codex standards were ineffective or 
inappropriate to fulfil Canada's legitimate obj ectives as required by Article 2.4 of the TBT 
Agreement.  
166. Moreover, the measures appeared not to meet  the objectives identified by Canada.  In 
particular they did not allow for technical a dvances in cheese production, did not provide for 
consistency with international food standards, did not provide uniform composition and nutritive 
value and they had not demonstrated that they coul d protect consumer interests.  Interest was also 
expressed in receiving answers to the questions raised by New Zealand. 
167. The representative of Switzerland  shared the concerns expressed. In particular, her delegation 
could not see how these measures would be useful  for consumers and why they were not in 
accordance with the Codex standards.   She stressed that the measures might have a negative impact on 
market access for milk protein concentrates. 
168. The representative of the European Communities  recalled that, at the November 2007 meeting 
of the Committee, Canada had explained that th e Canadian Food Inspection Agency was reviewing 
the comments received, and that these comments would be taken into account.  Her delegation regretted that the regulation was adopted in December 2007, shortly after the meeting of the 
Committee, and was due to enter into force in December 2008, without pr oviding delegations with 
responses to the comments that had been submitted nor additional information on the status of the 
revision.  She noted that, although in its final publ ication Canada had made some revisions to the 
benefit of cheese imports, some of the more serious concerns raised had not been taken into account.  
169. It was the European Communities' view that th e measure, in particular the licensing system, 
the new compositional standards and the requirement s to prove compliance, would have a negative 
impact on EC exports to Canada of certain ch eeses and basic products such as milk protein 
concentrates.  The representative of the Euro pean Communities stressed that the mandatory 
requirements appeared to create unnecessary obst acles to trade and raised WTO incompatibility G/TBT/M/44 
Page 30  
 
  concerns.  In this context, the beneficiary of the measure seemed to be the Canadian milk industry.  
For example, some references were made in the regul atory impact analysis statement attached to the 
Canadian regulation which referred to the growth of  the dairy sector in Canada.  She added that the 
revised regulations were being ex amined and additional comments in writing would be provided.  She 
urged Canada to take into account the comments made in the Committee and those that would be 
submitted and amend the regulations. 
170. The representative of the United States
 echoed the concerns raised.  While her delegation 
appreciated the adjustments to the compositional cheese standards to take  into account concerns 
regarding the cheddaring process and "traditional Ch eddar Cheese", outstanding concerns with respect 
to the potential market access im plications remained.  She noted that the issue was still being 
reviewed and that the measure’s impact on trade flows would be monitored closely. 
171. The representative of Canada  explained that the revised regulations harmonized the definition 
of milk products for cheese, in both the Food and Drug Regulations a nd the Dairy Products 
Regulations. This change would cl arify and provide consistency in the ingredients which could be 
used in the manufacture of cheese for the Canadian market.  She noted that the regulatory initiative 
was published on 26 December 2007 and that, in or der to provide manufacturers and Canadian 
importers with sufficient time to adapt to the re quired changes, the amended regulations would come 
into force on 14 December 2008. 
172. The representative of Canada further highlight ed that the regulations required a minimum 
level of casein derived from various milks to produc e various cheeses, but allowed the use of other 
milk products, such as milk protein concentrat es, skimmed milk powders and whey protein 
concentrates. With respect to th e comments about consistency with WTO obligations, she stressed 
that these new harmonized cheese standards clarified the permitted ingredients for varietal cheeses 
and would provide consumers with greater produc t uniformity.  All cheeses bearing a particular 
varietal name would possess similar characteristics, irrespective of where they were purchased or by 
whom they were manufactured or distributed.  Th is reduced the risk of consumer confusion and 
prevented the use of deceptive practices.  Her delegation did not agree with those Members who 
asserted that the regulation was unnecessarily trade restrictive and would not be beneficial to Canadian consumers.  Many imported cheeses would al ready be consistent with  the regulations and it 
was expected that the amended regulations would not lead to reductions in the volume of imported 
cheeses.  Canada filled its annual cheese tariff rate quota, and imported specialty cheeses were in high 
demand among Canadian consumers. 
173. In Canada's view, assertions that  the regulations would result in a reduction in imports of milk 
ingredients, including milk protein concentrates we re unsubstantiated.  Use of milk ingredients in 
cheese manufacturing varied between cheese processors  and there was no evidence that the minimum 
quantity of casein required by the regulations would serve as an effective constraint to the existing 
usage of milk ingredients such as milk proteins concentrates.  The representative of Canada further 
noted that the measure harmonized Canadian regulati ons with Codex standards by allowing the use of 
both milk and milk products in the manufacturing of cheese.  Previously, the Food and Drug Regulations did not permit the use of milk products in the manufacturing of cheese.  
174. The representative of Canada stressed that Me mbers' comments had been taken into account. 
Specific requirements for "traditional Cheddar Cheese " had been removed and requirements for "aged 
Cheddar Cheese" added, thereby aligning the measur e with Codex standards.  Specific provisions had 
also been made in the final regul ation for lower-fat cheeses, which cl arified that ultra filtered milks 
were permitted as ingredients for cheese.  She also  clarified, in reply to a point raised by New 
Zealand, that Canada had not initiated any regulat ory process for establishi ng compositional standards 
for other dairy products.  For instance in the case of yoghurt, there were no national compositional 
standards and none were intended.  G/TBT/M/44 
 Page 31 
 
 
  175. With respect to the licensing regime, the food industry was responsible for having measures 
in place to verify that all products met the appropr iate regulations, and the Canadian Food Inspection 
Agency (CFIA) would assess compliance.  The licensi ng regime would continue to require the use of 
an import declaration whereby the importer attests th at the product meets all Canadian requirements. 
More information would be provi ded to trading partners on the importer licensing regime as it was 
further developed in 2008.  In c oncluding, the representative of Canada stressed that comments were 
welcome and that her delegation was willing to meet  with trading partners to discuss any concerns 
with this regulatory initiative.  
(vii) India - Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20) 
176. The representative of the United States  appreciated the bilateral discussions held with India, 
in which his delegation had gained a better understa nding of the status of the Bureau of Indian 
Standards protocol on conformity assessment pro cedures for tyres.  His delegation had sought to 
clarify the objectives and requirements of this prot ocol, whether it was mandatory or voluntary, and 
had encouraged India’s continue d active membership in UNECE Wo rking Party 29 and conveyed the 
potential benefits of a UNECE Agreement on a global  technical regulation for tyres.  He noted that 
India had confirmed that the scheme was voluntary, and that no decision had been taken to make it 
mandatory.  Relevant developments in the work of the global technical regulation had also been 
discussed, and the outcome of these discussions would be shared with interested stakeholders in 
capital.  His delegation was open to a continued, c onstructive dialogue with Indian authorities on this 
issue. 
177. The representative of the European Communities  shared the same understanding as the 
United States with respect to the regulations on tyres and tubes.  He expressed his delegation's 
encouragement for India's active participation in the 1998 UNECE agreement discussions on a global 
technical regulation for tyres.  His delegation was al so interested in having further information about 
the licence fee structure for imported and domestic tyres. 
178. The representative of Japan  noted that Japanese industry had expressed some concerns 
regarding this proposed classification system for th e regulation of tyres and that his delegation would 
continue to engage in discussions, especially on specific issues such as the implementation period and 
conformity assessment procedures. 
179. The representative of India  appreciated the useful exchange of views with interested 
delegations and stressed that comments would be conveyed back to his authorities in capital. 
(viii) Korea – Fish Heads 
180. The representative of New Zealand  recalled that at the July 2007 meeting of the Committee 
his delegation had reported that some progress on th e matter had been signalled by Korea, with the 
announcement of the intention to add hake heads to the national food code and that the issue had been considered by the Korea Food and Drug Administra tion (KFDA) Food Sanitation Council. However, 
contrary to expectations, the changes to the Kor ean food code had not been made.  Instead, the 
Council had again delayed its decision, citing a lack of information on the food safety of the product.  
181. The representative of New Zealand stressed that his delegation considered this further delay 
unacceptable.  Over the years, New Zealand had provided ample information to the Ministry of Maritime Affairs and Fisheries on the food safety i ssues related to this product.  He sought the 
cooperation of Korea to ensure the required changes to the Korean food code were made swiftly and 
this issue finally resolved.  In the meanwhile, he  stressed, edible hake heads caught in New Zealand 
waters and processed by New Zealand boats we re still prohibited from entering the Republic of 
Korea, while hake heads caught in New Zealand wa ters and processed by Korean boats were allowed G/TBT/M/44 
Page 32  
 
  entry into the Korean market.  While this s ituation remained unresolved, his delegation would 
continue to raise the matter in the TBT Committee. 
182. The representative of the European Communities
 pointed out that, with regards to trade in 
edible cod heads with Korea, bilateral negotia tions were on-going and it was hoped that the two 
parties would be able to reach an agreement and conclude the matter in the near future. 
183. The representative of Korea  noted that close bilateral talk s between relevant agencies of 
Members were on-going. The Korean Government w as in the process of revising the domestic food 
code.  He would report the concerns back to his cap ital with a view to solving this long-standing issue 
as soon as possible. 
(ix) Sweden - Restrictions on the use of  Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/SWE/64) 
184. The representative of Jordan  sought an update from the European Communities on the 
bilateral discussions with Sweden on this i ssue and on the results of these discussions.   
185. The representative of Israel  reiterated his delegation's positi on that the prohibition was an 
unnecessary obstacle to international trade within the meaning of Article 2.2 of the TBT Agreement.  
Although Sweden had justified the measure invoking the protection human health, the existence of a 
risk had not been demonstrated.  Under the TBT Agreement, Sweden could not recur to a 
precautionary principle or claim that a potential risk existed.  He echoed Jordan's request for an update 
on the matter. 
186. The representatives of the United States  and Japan  also sought a report on this issue. 
187. The representative of th e European Communities  pointed out that bilateral discussions with 
Sweden were still on-going and were progressing po sitively.  She stressed that comments by WTO 
Members were being taken into account and hoped that  a solution would be found in the near future. 
(x) Norway - Restrictions on the use of  Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/NOR/6) 
188. The representative of Norway  recalled that the Norwegian draft regulation on deca-BDE had 
been sent for a public hearing in the spring of 2005, both nationally and internationally, and then 
notified to WTO and that it was originally scheduled  to enter into force on 1 July 2006.  She pointed 
out that the regulation had been adopted on 9 December 2007 and would enter into force on 
1 April 2008.  According to the regulation, the manuf acture, import, export, sale and use of substances 
and preparations containing 1 per cent by weight of deca-BDE would be prohibited.  The means of 
transport were exempted by the prohibition.   
189. It was stressed that several reports concer ning both health and environmental effects 
supporting the concerns regardi ng deca-BDE had been published since the notification of the 
Norwegian draft regulation, and that  references were available to in terested delegations.  An English 
translation of the provisions regarding deca-BDE, including the amendments made, was also available 
to interested delegations. 
190. The representative of Israel  reiterated his delegation's concerns with the measure.  In 
particular, his delegation was of the view that the proposed prohibition was not based on available 
scientific and technical information and that its application would constitute  and unnecessary obstacle 
to international trade within the meaning of Article 2.2 of the TBT Agreement.    G/TBT/M/44 
 Page 33 
 
 
  191. The representative of Japan  thanked Norway for the update and regretted that the measure 
would enter into force on 1 April 2008. 
192. The representative of Jordan  agreed with Israel that th ere was not sufficient scientific 
evidence which proved the impact of deca-BDE on hea lth and the environment and that the restriction 
was an unnecessary obstacle to the international trade. 
(xi) China - Revision of the list of toxic chemicals s everely restricted in the People's Republic of 
China in the regulation for environmental management on the first import of chemicals and the import and export of toxic chemicals 
193. The representative of Japan
 recalled that at the previous meeting of the TBT Committee, in 
the context of the Transitional Review Mechanism,  China had stated that the regulation was being 
revised and sought an update on the matter.16  He further invited China to clarify whether importers 
would be again required to pay the registration fee at the end of the two year registration cycle. 
194. The representative of the European Communities  recalled the concerns expressed by his 
delegation at the previous meeting of the TBT Co mmittee in the context of the Transitional Review 
Mechanism and joined the representative of Japan in requesting an update on the review of the 
Chinese toxic chemicals legislation. 
195. The representative of China recalled that at the November meeting of the Committee his 
delegation had promised to review th is regulation and confirmed that c onsultations to this effect were 
on-going in his capital. 
(xii) Israel – Infant formula 
196. The representative of the United States  recalled that his delegation had expressed concerns on 
the infant formula regime in Israel at the past tw o meetings of the Committee.  He stressed that US 
infant formula manufacturers were willing to comply with regulations that were published, treated all 
producers equally, were clear and consistent a nd based on science.  His delegation's understanding 
was that the Government of Israel was considering the promulgation of new rules.  However, reports 
suggested that the new regulations would not address the expressed concerns, particularly with respect 
to consistent application to a ll infant formula entering the Isr aeli market.  He sought further 
information on the issue and invited Israel to notify any proposed regulations to the WTO. 
197. The representative of Israel  said that in light of grave public health incidents following 
imports of infant food, the issue was sensitive.  Bilateral contacts were  on-going between various 
Israeli authorities, regulators and different stakehol ders in order to find an agreed solution to the 
concern of the United States. 
(xiii) United States – Proposed Rule on Labelling and  Advertising of Wines, Distilled Spirits and 
Malt Beverages (G/TBT/N/USA/290 and Add.1) 
198. The representative of the United States  recalled that Argentina had submitted comments on 
the notice by the Alcohol and Tobacco Tax and Trad e Bureau (TTB) of the US Treasury Department 
of its proposed rulemaking on wine labelling, wh ich was notified in August 2007 and for which the 
comment period had been extended until 27 January 2008.  He explained that, through the notice, 
TTB proposed to amend its regulations to require a statement of alcohol content and a "Serving Facts" 
panel on alcohol beverage labels .  TTB proposed to make these new requirements mandatory three 
                                                      
16 See G/TBT/M/43, para. 181, in the context of the "Sixth Annual Transitional Review Mandated by 
paragraph 18 of the Protocol of Accessi on of the People's Republic of China." G/TBT/M/44 
Page 34  
 
  years after the date of publication of the final regulation in the US Federal Register.  TTB was 
considering the comments received and would likely not make a determination until 2009. 
199. The representative of the United States furthe r noted that the World Wine Trade Group, of 
which Argentina was a member, had a labelling ag reement which did not prevent a country from 
establishing a nutritional label.  He stressed that, according to experts on this matter, other WTO 
Member such as Australia, New Zealand and Japan al so required some type of labelling on wine.   
(xiv) India - Drugs and Cosmetic Rules 2007  
200. The representative of the European Communities
 reiterated his delegation's concerns about 
India's draft amendment concerning drugs and cosmeti cs rules.  He sought an update with respect to 
the state of play of the measure and to the inten tion to notify this draft in accordance with Articles 
2.9.2 and 5.6.2 of the TBT Agreement.  It was his delegation's understanding that, according to the 
existing regulation on cosmetics as currently applied in  India, prior to importation, products needed to 
obtain a "non-objection" certificate from the Ministry of Health.  To obtain this certificate, comprehensive information about th e product had to be submitted.   
201. Additionally, the representative of the European  Communities noted that there would also be 
a requirement to register imported cosmetics.  Registration would require  disclosure of sensitive 
propriety information and would also  imply delays until the imported cosmetics could be marketed in 
India.  It was stressed that, according to the Eu ropean Communities' preliminary assessment of this 
draft, the requirement for registration of cosmetic products would be overly restrictive and could be in 
contrast to the obligations of the TBT Agreement.   
202. The representative of the United States
 shared many of the concer ns raised by the European 
Communities.  He noted that his delegation had sought to better understand the objectives and 
rationale of the proposed new regulations and, in  particular, how the regulation requirements were 
expected to increase product safety for consumers.  The concerns of US industry had been conveyed 
to the Indian authorities, in particular with regard s to the perception that the measure would be overly 
burdensome and could result in costly delays.  He  also sought clarification on whether the measure 
would apply to all cosmetics entering the Indian  market, imported or domestic sources, and that 
implementation would not solely target imports  He appreciated the efforts made by the Indian 
delegation to discuss these issues and to convey these views to the Indian authorities and looked 
forward to further discussions .  
203. The representative of India  reiterated his delegation's commitment to comply with the 
principles of the TBT Agreement and stressed that the proposed registration requirement for cosmetic 
products would be notified at the earliest.  The pr oposed registration requirements were intended to 
harmonize standards of imported cosm etic products with those applied to domestically products.  He 
recalled that fruitful bilateral discussion had been  held with both the European Communities and the 
United States and assured the Committe e that the concerns expressed w ould be sent to the appropriate 
authorities in capital for due consideration.  His de legation was ready to engage in further bilateral 
discussions in the future.   
(xv) China – Administration on the Control of Po llution Caused by Electronic Information 
Products (G/TBT/N/CHN/140 and Add.1) 
204. The representative of Japan  sought clarification on the development process of the national 
standard for testing methods with respect to th e measure above, and reitera ted his delegation's hope 
that the standard would be notified in accordance with the TBT Agreement.  G/TBT/M/44 
 Page 35 
 
 
  205. The representative of China  stressed that the objectives of the measure were to protect the 
environment and human health, which were legitima te objectives as stated in Article 2.2 of the TBT 
Agreement.  Regarding the relevant detection meth ods and standards, his delegation would fulfil the 
transparency obligation in the TBT Agreement. 
(xvi) United States – Flammability of Clothing Textiles (G/TBT/N/USA/242) 
206. The representative of China  recalled that his delegation ha d submitted comments on the draft 
regulation on the flammability of clothing textiles, and raised concerns at the July 2007 meeting of the 
Committee. He recalled that in that meeting, the US delegation had said that the Consumer Products Safety Commission (CPSC) was considering Chin a's comments in its review of the updated 
regulation.  He sought information on whether the review had been finished, and how the Chinese 
comments had been taken into account by CPSC. 
207. The representative of the United States
 recalled that at the July 2007 meeting, his delegation 
had explained that CPSC’s intent was to update th e language of a standard that had been drafted in 
1952 to better reflect current practices and tec hnologies, but the intention was not to alter the 
substantive provisions of the standard .  It had also been noted that CPSC’s work was at an early stage, 
and that the revisions were not expected to be im minent.  His delegation would keep trading partners 
informed of developments. 
(xvii)  China – Draft standards on lithium batteries for mobile phones 
208. The representative of Japan  recalled that his delegation had raised concerns with respect to 
China's Ministry of Information Industry's dr aft lithium battery standards for mobile phones17 and 
sought clarification on three issues.  First, could Ch ina confirm that the standards would be voluntary?  
Second, could China confirm that, if the standards were to become compulsory, whether by taking off 
the "IT" suffix or by citation in a different law,  these would be notified under the TBT Agreement?  
Third, while he welcomed the initiative of the Minist ry of Information Industry to convene interested 
companies to provide inputs for a proposed generi c safety standard of lithium batteries, he sought 
clarification about the relationship between such pr oposed safety standard and the draft standards for 
mobile phone batteries.  Were the mobile phone batte ry standards still being considered separately 
from the generic safety standard of lithium batteries, or did one encompass the other?  In concluding, 
he stressed the importance of transparency an d harmonization with international standards. 
209. The representative of th e European Communities  supported the comments made by Japan.  
He underlined that one of the aspects of the proposed  standards was the definition of certain sizes and 
shapes for mobile phones and was of the view that  the development of a parallel market of non-
original batteries, which would be developed outside the direct cont rol of the handset manufacturers, 
would entail a significantly higher risk of accident du e to battery non-compliance.  In turn, this was 
likely to raise complex issues pertaining to produc t liability in case of accidents arising from the use 
of handsets with a non-original battery.  Handset manufacturers would not be able to guarantee the 
safety of the handsets when used with batteries th at they had not supplied.  China was invited to 
consider the implications of this proposed standard  also from the point of view of product liability.  
210. The representative of the United States  shared the views of Japan and the European 
Communities, and sought a status report on the issue from China. 
211. The representative of China  noted that the standards were in tended to protect the interests of 
consumers and the environment, as well as to pr omote a sound development of the industry.  The 
                                                      
17 See G/TBT/M/43, para. 161, in the context of the "Sixth Annual Transitional Review Mandated by 
paragraph 18 of the Protocol of Accessi on of the People's Republic of China." G/TBT/M/44 
Page 36  
 
  standards were open for comments from all stak eholders and were still under discussion.  The 
question on the generic safety standards for lithium batteries raised by Japan would be conveyed to 
relevant authorities in Beijing. 
(xviii)  Brazil - Registration requirements for medical devices 
212. The representative of the United States
 appreciated Brazil's efforts to engage in a constructive 
dialogue on the concerns which had been raised in respect of the above-mentioned measure, although 
his delegation still believed that Reso lution 185 should have been notif ied to the WTO.  One issue of 
concern was related to the difficulties with fulf illing the expansive information requirement as 
originally formulated and Brazil's efforts to a ddress this, including through additional outreach to 
industry, were welcome.  Neverthele ss, he invited Brazil to take official action to clarify guidance for 
importers without delay.  Greater clarity on the ob jectives of Resolution 185 would also be welcome, 
so that all involved parties could gain a sense of how those objectives could be met through this 
measure. 
213. The representative of the United States furt her welcomed Brazil’s receptivity to the 
suggestions made by US industry regarding their pe rceptions of the burden and uncertainty associated 
with this regulation.  He invited Brazil to impr ove the ability of US industry to comply with the 
measure, while minimizing any unnecessary disrupti on to trade in medical devices through additional 
denials of commercialization.   
214. The representative of the European Communities  agreed with the poin ts made by the United 
States.  It was also his delegation's view that the measure should have been notified under the TBT 
Agreement.  He encouraged the Brazilian authoriti es to continue their exchange of views with the 
economic operators, to provide replies to the concer ns expressed and to consid er further amending the 
resolution. 
215. The representative of Canada  echoed the comments made and noted that Canadian industry 
was seeking clear, transparent and predictable guidance for importers. 
216. The representative of Switzerland  shared the concerns expressed and believed that, since the 
TBT Agreement was applicable to the Reso lution, this should have been notified. 
217. The representative of Brazil  reiterated his delegation's position that the Resolution 185 was 
neither a technical regulation nor a conformity assessme nt procedure.  He stre ssed that the definition 
of a technical regulation in the TBT Agreement and the Appellate Body decision in the EC Asbestos 
case18 were illustrative of how to determine if a regulation was a technical regulation or not.  A 
technical regulation had to be applicable to an identified product or group of products, define the 
characteristics of the product and determine th at compliance with those characteristics was 
mandatory.  While Resolution 185 was applicable to  an identified group of products, it did not lay 
down any product characteristics that medical de vices had to comply with.  Resolution 185 only 
required producers to declare some economic information about medical devices.   
218. The representative of Brazil stressed that Resolution 185 was not a conformity assessment 
procedure either, since it did not establish pro cedures to determine if medical devices fulfilled 
relevant requirements in technical regulations or standards as provided for in the definition contained 
in the TBT Agreement.  Therefore, Resolution 185  was not covered by TBT provisions and did not 
need to be notified to the TBT Committee.  He pointed out that the Agência Nacional de Vigilância 
                                                      
18 European Communities - Measures Affecting Asbestos and Products Containing Asbestos  (WT/DS 
135/AB/R).  G/TBT/M/44 
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  Sanitária  (Anvisa)19, had sought to ensure transparency in  the process of elaboration and in the 
implementation of the measure.  Public consulta tions were held, comments from companies and other 
stakeholders were taken into account, and time was given for co mpanies to adapt to the new 
requirements.  Representatives from the US, the EC, Canada and the private sector had also met with Anvisa to clarify remaining doubts.  His delegation was ready to continue to provide clarification 
about the measure bilaterally to interested Members.  
(xix) Thailand - Labelling Requirement for Snack Foods (G/TBT/N/THA/215 and Add.1) 
219. The representative of the United States
 welcomed the actions taken by the Thai authorities in 
response to the concerns raised, including postponin g the implementation of the measure and issuing a 
revised regulation, as notified in G/TBT/N/THA/215. Add.1.  His delegation had taken note of the 
response provided by the Thai FDA in January 2008 to questions and concerns raised by the United 
States on the revised regulation, which indicated th at nutritional labelling should be directed at all 
food categories and that mandatory labelling requir ements for snack foods and other foods "deemed 
necessary" would eventually be put in place "at appropriate stages".   
220. Although the United States appreciated Thaila nd’s efforts on these revisions and supported 
Thailand’s goal of promoting a healthier citizenry , US industry continued to raise questions as to 
whether the measure was necessary in light of alterna tives.  In this regard, the representative of the 
United States drew the Committee's attention to th e ongoing work in Codex to review strategies 
regarding diet and health, in part stemming from c oncerns with the WHO’s Draft Action Plan for the 
Implementation of the Global Strategy on Diet, Ph ysical Activity and Health.  Work should be 
directed towards appropriate and consistent schemes  that could have the benefit of both encouraging 
better health and facilitating trade.  His delegati on looked forward to a continued dialogue on this 
issue with the Thai authorities. 
(xx) China – Domestic Gas Cooking Appliances 
221. The representative of the European Communities  noted that concerns remained on the 
proposed national standard on gas cooking appliances.  It was his delegation's understanding that the 
amended standard would be impl emented as of 1 May 2008 and he requested China to postpone its 
implementation until the issue was solved by means of  bilateral talks with experts in Beijing.  His 
delegation's main concern was th at the requirements for minimum input of burners, as well as 
minimum temperature resistance of burners, which was set at a specific temperature, would exclude certain aluminium burners from the Chinese market whic h had been allowed so far.  This would also 
lead to higher risks for the safety of the Chinese users and to an incr ease in the gas consumption.  His 
delegation considered that the requirement as propos ed was not sufficiently justified by a legitimate 
objective and would not be in line with Article 2.4 of the TBT Agreement.  
222. The representative of China
 noted that his delegation had provided written replies to the 
European Communities and that comments, includi ng those from other WTO Members, had been 
taken into account.  For example, the revised sta ndards eliminated redundant requirements as all parts 
and components of the burners had to be made of me tal materials with melting point of 700°C.  This 
was done with a view to incorporating the requi rements of relevant EC standards and enabled 
adoption of new materials thereby encouraging inno vation.  For those comments that had not been 
accepted, a detailed explanation of the reasons had been provided.  For example, with respect to the provision that the fire hole of burners should be ma de of materials that could withstand temperature 
over 700°C, he explained that this requirement was aimed at ensuring safe opera tion of intense fire for 
quick frying.  This was a traditional Chinese way of cooking, so the fire hole was the hottest part of 
the burners and stricter requirement had to be adopted. 
                                                     
 
19 www.anvisa.gov.br  G/TBT/M/44 
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  (xxi) Moldova - quality and control measures fo r bottled, non-alcoholic beverages including 
mineral, natural water and soft drinks (G/TBT/N/MDA/13) 
223. The representative of the European Communities
 thanked Moldova for taking into account 
the comments made by her delegation and for am ending the draft measure, which would only cover 
domestic soft drinks, thereby elimina ting any restrictions on imported goods.  
C.  EXCHANGE OF EXPERIENCES  
1. Good Regulatory Practice 
224. The Chairman reported on the Workshop on Good Re gulatory Practice held on 18-19 March 
2008 (Annex 1, below).20 
225. The representative of Egypt  said his delegation appreciated the wealth of information 
provided at the workshop.  He suggested a mech anism be established to  enhance exchange of 
information on good regulatory practice, including between developed and developing countries.   
226. The representative of the United States  noted one of the main less ons learnt at the workshop 
was that all Members, regardless of their level of de velopment, needed to con tinue to advance in the 
area of good regulatory practice.  He drew the Committee's attention to a paper submitted by his 
delegation on Determining the Need to Regulate (G/TBT/W/285).     
227. The various sections in the paper dealt with: id entification of the need for a regulation;  
consideration of legal requirements (including the TB T Agreement);  consideration of alternatives;  
risk assessments;  cost-benefit analyses; and, the continual reassessment of need during the regulatory 
process.  The paper also contained a useful lis t of questions that US regulators asked when 
determining whether or not to regulate and also provided illustrations involving airbags, child 
restraints on aircrafts, trees in flight paths and the impact of considering the body's biorhythms in 
determining safety.  The representative of the Un ited States invited comments on the paper and hoped 
it would stimulate a productive discussion as the Committe e entered the Fifth Triennial Review of the 
TBT Agreement.   
228. The representative of Canada  noted that much interest ha d been expressed in the various 
elements of good regulatory practice, including on Regulatory Impact Assessment (RIAs).  Her 
delegation believed that further discussions in the Committee could be useful.  For example, 
discussions could focus on a better understanding of how RIAs were prepared  and how international 
trade obligations were addressed in RIAs.   
229. The representative of th e European Communities  believed that the workshop had contributed 
to furthering the Committee's discuss ions on good regulatory practice, par ticularly in view of the Fifth 
Triennial Review.  His delegation particularly appr eciated the participation and interest taken by 
developing countries, which, he said, showed th at efforts had been undertaken to develop good 
regulatory practice.  Good regulatory practice coul d become a standing item of technical assistance 
and his delegation would explore this issue further.  
230. The representative of the European Communities said that the workshop had highlighted that 
there were several facets of good regulatory practice.  Some aspects related to the tools to identify the 
need for regulation and how to ensure transparen cy, openness and accountability of the process; other 
                                                      
20 A Summary Report of the event is contained in document G/TBT/W/287.  More information, 
including the programme and presentations made, is also available on the WTO TBT Website at the following 
address:  http://www.wto.org/english/tratop_e/tbt_e/wkshop_march08_e/wkshop_march08_e.htm   G/TBT/M/44 
 Page 39 
 
 
  aspects pertained to the intrinsic quality of legisla tive texts of regulations.  Discussions on referencing 
standards in technical regulations could be contin ued within the framework of the Fifth Triennial 
Review.   
231. The representative of Zimbabwe  welcomed the support provided through the DDA Global 
Trust Fund and arrangements made to enable deve loping country Members to attend the workshop.  
Developing countries were at various stages of im plementing the TBT Agreement and the information 
gathered during the event would he lp improve regulatory practices.  
232. The representative of Senegal  supported the comments made by Zimbabwe, adding that 
capacity building for developing countries was part icularly important in the area of good regulatory 
practice. 
2. Conformity Assessment Procedures 
233. The representative of Singapore  noted that, with reference to Article 6.3 of the TBT 
Agreement, a multilateral Mutual Recognition Agreement (MRA) on electrical and electronic 
equipment involving all member countries of the As sociation of South East Asian Nations (ASEAN) 
had been developed in year 2000, signed in 200 2 and successfully implemented in 2004.  The MRA 
involved issues such as the IECCB Scheme and ILAC and IAF multilateral arrangements on 
accreditation of testing laboratories and certificati on bodies.  Through the MRA, regulatory bodies of 
ASEAN countries mutually accepted tests reports and certification by designated conformity assessment bodies, thereby eliminating re-testing and re-certification and improving market certainty.  
ASEAN was building on this MRA with a view to  harmonizing the different regulatory regimes 
affecting electronic equipment and an ASEAN El ectric and Electronic Equipment Agreement had 
been signed in December 2005.  Through this Ag reement, Member countries had committed to amend 
legislation and to put in place a harmonized regi me so as to achieve one standard, one test, one 
certification accepted by all by December 2010. 
3. Technical Assistance 
234. The Chairman
 recalled that at its November 2007  meeting, the TBT Committee had a 
constructive exchange of experiences based on a do cument submitted jointly by Canada and Costa 
Rica (G/TBT/W/283).  The Committee also he ard from UNIDO regarding needs assessment 
(G/TBT/GEN/63).  Discussions held in the c ontext of the Workshop on Good Regulatory Practice 
were also useful from a training and capacity buildin g perspective:  it was valuable to know how other 
Members were implementing the TBT Agreement.   
235. The Chairman further stressed that the Co mmittee attached importance to technical 
assistance.  The exchange of experiences and identif ication of good practices in the delivery and 
receipt of technical assistance, in line with the mandate from the Fourth Triennial Review, could help advance Members' objective of increasing transparen cy in the need and availability of technical 
assistance.  The Committee's attention was drawn to a proposal submitted by the United States 
contained in document Job(08)/15, which related to  some of the recommendations contained in the 
Fourth Triennial Review. 
236. The representative of the United States
 recalled that, at the November 2007 meeting of the 
Committee, her delegation had enquired if other WTO Members would be interested in examining the 
work carried out by international standardizing bodies to broaden and deepen developing country 
participation in standards development activities at the technical level, as well as their efforts to 
strengthen developing country use of standards in specific sectors, both in the market place and in 
technical regulations.  Introducing the US proposal contained in Job(08/15), the representative of the 
United States said her delegation recommended a practical approach  to examining the role of G/TBT/M/44 
Page 40  
 
  international standards in economic  development.  In this regard, the paper proposed to use case 
studies to examine avenues through which relevant international standards had improved quality of 
products, solved specific regulatory problems  or facilitated trade in new markets. 
237. The representative of the United States further stressed that the paper offered a series of 
questions for Members to consider and discuss.  The goal was to draw out possible elements of 
interest so that a workshop might be organized that  could reflect the broad cross-section of interests 
across WTO Members.  There were many experts i nvolved in developing intern ational standards that 
could convey the technical aspects of their work on a specific product standard in the context of the 
larger global market dynamics, giving Members ne w perspectives on the intersection of standards, 
trade and development.  It was her delegation's hope that the Committee would find this contribution 
to be a constructive one, which c ould take Members into a deeper dialogue on the shared work in 
achieving the objectives of the TBT Agreement.  
238. The representative of Malaysia
 welcomed the proposal from the United States and highlighted 
that low participation of developing countries in inte rnational standardization had been raised in past 
triennial reviews and remained a concern.  This is sue should be an element in future work that the 
Committee would undertake. 
239. The representative of Egypt  believed the paper put forward by the United States raised some 
important questions that needed to be further develo ped and analyzed.  He shared Malaysia's concerns 
on the low participation of developing countries in international standardization activities and said the 
Committee should discuss the issue.   
240. The representative of the European Communities  said that the proposal from the United States 
was a useful contribution to furthering the Comm ittee's work on technical assistance; it aimed at 
implementing an item of Future Work from the F ourth Triennial Review.  His delegation would 
further discuss the proposal and submit comment s, including on the workshop programme and 
identification of experts who could contribute to the event. 
241. The representative of Canada  said the United States' proposal provided an opportunity for 
Committee members to engage in a constructive di scussion.  The case study format and the idea to 
focus on sectors of interest to developing countries was well suited to providing useful information on 
available technical assistance.  Canada looked forw ard to contributing to the further development of 
the workshop.  
242. The representative of Japan  supported the proposal from the United States.  Some points of 
particular interest were: increasing participation in  standards-setting organizations; and, the role of 
regional standardizing bodies.  His delegation would be willing to make a presentation at the 
workshop, should the Committee proceed with the event.  
243. The representative of Korea  supported the proposal from the United States.  Many 
international standard-setting or ganizations had accumulated much experience and know-how and it 
would be useful to discuss their work.   More specific comments would be provided in due course.  
244. The representative of China  welcomed the proposal.  His delegation would refer it to capital 
and also encourage its considerati on by standardizing organizations. 
245. The representative of Malawi  welcomed the proposal from the United States and agreed with 
the points made by Malaysia and Egypt on low partic ipation of developing coun tries in international 
standardization work.    G/TBT/M/44 
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  246. The representative of Chile  supported the idea of a workshop as her delegation was convinced 
of the importance of standards for development.  Th e case studies format was very useful, as concrete 
problems could be analyzed and this would enab le countries to participate in the activities of 
international standardization bodies.  
247. The representative of Brazil  said his delegation was analyzing the proposal and comments 
would be provided in the future. 
248. The representative of Colombia  supported further work on the proposal from the United 
States.  He agreed with others as to the importan ce of developing countries' participation in activities 
of international standardizing organizations.  His de legation had had concerns in some instances as to 
the way discussions were handled and how determina tion of consensus in international standardizing 
bodies had been reached. 
249. The representative of Chinese Taipei  looked forward to participating in the workshop, if the 
proposal was adopted by the Committee.  
250. The representative of Cuba  supported the idea of a workshop and said more comments would 
be provided.  The questions put forward by the United States in Job (08)/15 should be further 
analyzed by the Committee in light of the interest of all Members. 
251. The representative of the Central African Republic  believed that United States' proposal 
would be beneficial to his country, where standa rdization activities were at an early stage of 
development. 
252. The representative of Antigua and Barbuda  stressed the importance of looking at information 
already available, and see how to move forward fro m there.  There had already been workshops on 
this issue that produced reports and on which there ha d been no follow-up.  Therefore, there should be 
commitment to follow-up on recommendations from previous activities.  
253. The representative of UNIDO  informed the Committee that his organization was involved in 
related technical assistance activities and would lo ok into the possibility of supporting developing 
countries to share their experiences and actively participate in the workshop. 
254. The representative of the United States  thanked Members for their support and expressed 
understanding in respect of the point made by Antig ua and Barbuda.  The idea was to use case studies 
of best practices and success stories to show paths that might be taken by all developing countries and 
organizations, in terms of finding so lutions and making standardization an engine for growth in global 
trade.  
D. OTHER MATTERS  
(i) Management of Toy Safety – Statement by China 
255. The representative of China  introduced China's export toy quality and safety control system.  
Toys were products largely used by families and qua lity and safety were thus particularly important.  
With global economic integration an d international labour division, toys were traded all over the 
world.  The combination of technical advantage of developed country Members in toy design and 
labour advantage of developing country Members in  manufacturing brought mutual benefits and the 
common prosperity that the WTO multilateral trading system was pursuing.  
256. China was a main toy producer and exporter in  the world.  With around 90 million pre-school 
children, China was also itself a big market for to ys.  China attached great importance to toy quality G/TBT/M/44 
Page 42  
 
  and safety control, and an effective management system had been established following efforts over 
some years.  Bearing in mind that 80 per cent of Chinese exported toys were made for original 
equipment manufacturer, the so-called OEM, the re presentative of China stressed that his delegation 
believed that made-in-China toys should always enjoy high quality and safety.   
257. First, there existed the legal framework and tec hnical standards to ensure that toys products 
were safe for all users, children or adults.  Chin a had adopted relevant ISO and IEC standards in the 
toy sector.  Second, a sound conformity assessment system guaranteed that all export toys met relevant requirements of the destined market.  Export toys had been listed as a compulsory inspection commodity, and toys failing to meet the required sta ndards could not be exported.  From 1 June 2007, 
China's Compulsory Certification System had been applied to six types of toys including electronic 
toys, dolls and plastic toys.  China had also established strict inspection systems, including "Export 
Toy Quality Registration System", "Export Toy Enterprises Classified Management System" and "Export Toy Routine Monitoring and Inspection System".  These systems ensured that toy 
manufacturers set up production process quality and safety control systems.  In case unqualified toys were found, the related enterprises had to correct th e problems before their products could regain the 
qualification of exportation.  
258. The representative of China further noted that  in 2007, to further increase the safety and 
quality level of China's export toys, AQSIQ had orga nized site visits to all 3540 export toy producers 
in China, and established a registration system fo r qualified toy paint suppliers.  AQSIQ had five 
professional toy testing centres located respec tively in Yangzhou, Gua ngdong, Shenzhen, Shanghai 
and Beijing, all of which were accredited by internat ional accreditation organizations.  The certificates 
and testing reports issued by these testing centres we re widely accepted all over the world.  Other toy 
exporting regions were also equipped with toy tes ting laboratories and professional inspectors.  The 
representative stressed that China ha d the ability to provide quality and safe toys and would continue 
its efforts in this respect.  
(ii) NAMA negotiations 
259. The representative of Peru
 encouraged representatives in the TBT Committee and capital-
based officials in charge of TBT to step up their coordination with officials in their capitals working 
on the NAMA negotiations.21  
III. THIRTEENTH ANNUAL REVIEW OF: 
A. THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT UNDER ARTICLE 15.3 
260. The Committee adopted  its report of the Thirteenth Annual Review of the Implementation 
and Operation of the TBT Agreem ent under Article 15.3 (G/TBT/23). 
B. THE CODE OF GOOD PRACTICE FOR THE PREPARATION , ADOPTION AND APPLICATION OF 
STANDARDS IN ANNEX 3 OF THE TBT AGREEMENT  
261. The Chairman  introduced the Thirteenth Edition of the WTO TBT Standards Code Directory 
prepared by the ISO/IEC Information Centre.  He also drew the Committee's attention to two lists 
prepared by the Secretariat.  The first (G/TBT/C S/1/Add.12) compiled the standardizing bodies that 
had accepted the Code of Good Practice in the period under review and the second 
                                                      
21 Subsequent to the TBT Committee meeting, the Se cond Revision of the Draft Modalities for Non-
Agricultural Market Access was issued.  This document contains, in Annex 5, the latest set of NTB textual 
proposals (TN/MA/W/103/Rev.1).   G/TBT/M/44 
 Page 43 
 
 
  (G/TBT/CS/2/Rev.14) compiled all the standard izing bodies that had accepted the Code since 
1 January 1995.   
262. The Committee took note  of this information. 
IV. TECHNICAL CO-OPERATION ACTIVITIES AND UPDATING BY OBSERVERS 
263. The representative of UNECE  updated the Committee on work of the UNECE Working Party 
6 on regulatory cooperation and standardisation polic ies.  Working Party 6 was an intergovernmental 
group of experts focusing on trans-national regulatory cooperation.  The representative explained that 
the "International Model for Technical Harmonization" comprised a set of voluntary mechanisms and 
principles for good regulatory practices that could be used by countries to align their regulatory 
regimes in specific sectors, product areas or geographic regions.  Five new initiatives were under way in the international model for regulatory coopera tion, on (i) Explosive Environment Equipment; 
(ii) Oil and Gas Pipeline Safety; (iii) Telecoms; (iv) Earth Moving Equipment; and (v) CIS Regional 
Initiative. 
264. It was emphasised that these initiatives enjoyed br oad participation and that Working Party 6 
was open to all UN member states and non-govern ment organisations approved by UN ECOSOC.  
Members of the TBT Committee were also welcome to  participate in the work.  The annual session of 
Working Party would be held in November 2008.  Following a request from Kenya, two additional 
panel sessions would be organi zed on private standards.  
265. Other relevant activities included the use of  market surveillance infrastructure as a 
complementary means to protect consumers and user s against counterfeit goods.  It was noted that 
relevant  information on these items  as available on UNECE website
22.  
266. The representative of the ITC  recalled a proposal made at the Fifth Special Meeting on 
Procedures for Information Exchange on a co aching program for national enquiry points.23  "Coaches" 
would be the experienced manage rs of national enquiry points in  developed or more advanced 
countries and the "coached staff" would be the st aff of less advanced national enquiry points in 
developing and least developed countri es.  He invited delegations who we re interested in this program 
to provide written expressions of interest and reca lled that some delegati ons had indicated their 
willingness to act as coaches and share their experi ences and know-how in information dissemination 
services. 
267. The representative of UNIDO  highlighted three issues.  Fi rst, four needs assessment case 
studies were being finalized.  Second, in relati on to conformity assessment and discussions about 
REACH, UNIDO was working on a EC-funded pr oject in Thailand for upgrading chemical 
laboratories in order to comply with REACH requi rements.  Third, UNIDO had developed, with the 
support of the Government of Austria, a chemical leasing business model approach. 
268. The representative of IEC  updated the Committee on the relevant activities undertaken by her 
organization (G/TBT/GEN/68). 
269. The representative of Codex  provided information on activities of the Codex Alimentarius 
Commission (G/TBT/GEN/69). 
                                                      
22 www.unece.org  
23 See G/TBT/M/43, Annex I para. 89-98.  See also G/TBT/M/43, Corr.1.  G/TBT/M/44 
Page 44  
 
  V. DATE OF NEXT MEETING 
270. The next regular meeting of the Committ ee will take place on 1-2 July 2008.   
_______________ 
  G/TBT/M/44 
 Page 45 
 
 
   
ANNEX 1 
REPORT BY THE CHAIRMAN ON WORKSHOP ON GOOD REGULATORY PRACTICE 
 
Report by the Chairman (Mr. Raiminder S. SIDHU)  
at the Regular Meeting of the TBT Committee of 20 March 20081 
 
  1. At the Fourth Triennial Review of the TBT Agreement, concluded in November 2006, the 
TBT Committee agreed to share experiences on a number of aspects relevant to good regulatory 
practice with a view to deepening understanding of the contribution good regulatory practice can make to the implementation of the TBT Agreement.   In this regard, a Workshop on Good Regulatory 
Practice was held at WTO Headquarters on 18 and 19 March 2008.  Participation of 102 capital-based 
officials from developing countries was sponsored through the WTO Global Trust Fund.   
2. Discussions at the Workshop were held in four panel sessions dealing with: general 
approaches of Members to good regulatory practice when implementing the disciplines of the TBT 
Agreement (Session 1);  internal transparency a nd consultative mechanisms (Session 2); regulatory 
impact assessment (Session 3); and regulatory c ooperation initiatives between Members (Session 4).  
The final programme is contained in document G/TBT/GEN/67/Rev.1 and a background note by the 
Secretariat is in document Job(08)/7. 
3. A key message in the First Session – and one that recurred throughout the two days – was the 
importance of established processes and procedures as a means of giving effect to good regulatory practice.  In other words, although there are many different ways of implementing the TBT 
Agreement, having a basic process backed by some form of legal instrument (such as a Decree in 
Chile, a Guide in Brazil, Acts or Executive Orders  in the United States) can strengthen efforts to 
integrate good regulatory practice into Members' regulatory structures.    
4. In the first session participants also discussed ways to reference standards in technical 
regulations, based on the Canadian experience, a nd several issues were raised in this regard, 
including: the advantages (and potential challenges) of  directly referencing standards in legislation; 
the cost of using the standards; and how to adapt a standard to fulfil the legitimate objective of the 
regulatory measure.  Some Members pointed at c onstraints for developing countries, such as 
difficulties in demonstrating compliance with sta ndards – particularly in cases where accreditation 
infrastructure is lacking. 
5. In the Second Session, it was observed that  transparency, openness and accountability are 
relevant to many, if not all, aspects of good regulatory practice.  The Session focussed particularly on mechanisms to enhance transparen cy in the development stage of proposed regulations.  Benefits 
were highlighted.  It was stressed, for instance, that participation by stakeholders helps ensure 
legitimacy to what the government does and the measures it chooses to implement.  Consultative 
processes enhance predictability and cl arity providing certainty for trad ers and also helps to increase 
awareness about government actions.  There are cha llenges as well and sometimes traps that need to 
be avoided.   It is important, for instance, that consultative processes are not dominated by particular 
interest groups.  As well, consultation should not be considered by regulators as a burden but rather as 
an instrument that adds legitimacy to regulatory decision making.   
                                                     
 
1 A Summary Report of the Workshop on Good Regulatory Practice is contained in G/TBT/W/287. G/TBT/M/44 
Page 46  
 
  6. The Third Session focused on how regulatory impact assessments can assist decision-making. 
As was stated by one participant:  a regulator y impact assessment induces governments to think 
harder about how to solve problems;  it is a decision-making tool.  One important benefit of RIAs is 
that they facilitate the identification of the need fo r regulation. In this regard presenters stressed the 
importance of considering alternatives - and, perhaps,  reconsidering the need for regulation in the first 
place.  It was noted that RIAs do not need to be comp lex, they can be flexible and adaptable in nature.  
When functioning well, they can help filter the flow  of new regulations and help ensure that these are 
less likely to create trade problems.  It was al so pointed out that because regulatory impact 
assessments are public, they boost accountability.  In this sense, again, RIAs are also a tool for 
transparency.  Finally, attention of participan ts was also drawn to the APEC-OECD Integrated 
Checklist on Regulatory Reform.   
7. In the Fourth Session participants heard a number of examples of regulatory cooperation 
activities between Members.  Many factors – all regarded as important to fostering cooperation 
between Members – were highlighted, including: pr omotion of dialogue (including at senior level); 
acting early to avoid trade problems before they arise; and providing resources to support cooperation 
and political commitment.  It was pointed out that  a fundamental component to regulatory cooperation 
is confidence-building:  personal contacts are also  essential.  Cooperation also has a capacity building 
component in that it helps build up understanding of  different systems thereby contributing to the 
convergence of regulations.   
8. Looking back on the two days of the Workshop, one general message sta nds out: regulation is 
a legitimate part of government activity and a major and increasingly important policy tool of 
government today.  Emphasis has shifted somewhat  from de-regulation to "smart" or "better" 
regulation – it is the quality of regulation that ma tters.  And this proces s of becoming better at 
regulating is an ongoing process – for all Members.  In other words, a lthough at differe nt levels, all 
Members face challenges.  There is scope here fo r Members to learn from each other in this regard 
and I can only encourage continued exchanges in this area between Members. 
9. Let me again thank participants to the work shop for their engagement.  I believe the 
discussions over the last two days have signi ficantly contributed to deepening Members' 
understanding of the contribution good regulatory pr actice can make to the implementation of the 
TBT Agreement. 
 
__________