RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/46 
23 January 2009 
 (09-0330) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 5-6 NOVEMBER 2008 
 
Chairperson:  Ms Xueyan GUO (China)
  
 
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 ..................................................................................................... ............26  
C. EXCHANGE OF EXPERIENCES ....................................................................................................................61  
1. Good Regulato ry Prac tice....................................................................................................... ............62  
2. Conformity Assessm ent Procedures ............................................................................................... .....63  
3. Transparency ................................................................................................................... ...................65  
4. Technical As sistance ........................................................................................................... ................65  
D. OTHER MATTERS ............................................................................................................................... ......66  
1. Workshop on the Role of Internationa l Standards in Econom ic Development ...................................66  
2. Proposal from Canada on Specific Trade Concerns...........................................................................67  
III. PREPARATION OF THE FIFT H TRIENNIAL REVIEW.............................................................68  
IV. ANNUAL TRANSITIONAL REVIEW (TRM) MANDATED IN PARAGRAPH 18 OF 
THE PROTOCOL OF ACCESSION OF THE PEOPLE'S REPUBLIC OF CHINA...................69  
V. TECHNICAL COOPERATION ACTIVITIES ................................................................................73  
1. Technical Cooperation Activities by Members.................................................................................... 73 
2. First Specialized Course on The TBT Agreement ...............................................................................73  
VI. UPDATING BY OBSERVERS.......................................................................................................... .73 
VII. REPORT (2008) OF THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE..............74  
VIII. DATE OF TH E NEXT MEETING................................................................................................. ....74 
 
                                                      
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/46 
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  I. ADOPTION OF THE AGENDA 
1. The Committee adopted the agenda contained in WTO/AIR/3251. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 
2. The Chairperson  recalled that latest list of statemen ts submitted under Artic le 15.2 of the TBT 
Agreement is contained in document G/TBT/GEN/1/ Rev.7, issued on 7 March 2008.  Since the last 
meeting of the TBT Committee, Colombia had submitte d a supplement to the revision to their original 
statement (G/TBT/2/Add.18/Rev.2/Suppl.2) and Mexi co had submitted a supplement to its original 
statement (G/TBT/2/Add.14/Suppl.1).  In total, since 1995, 117 Members had submitted at least one 
Statement on implementation under Article 15.2.   It  was noted that the latest list of enquiry point 
contacts was contained in document G/TBT/ENQ/34.2     
3. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) United States – Consumer Product Safety Improvement Act (G/TBT/N/USA/421) 
4. The representative of China  raised concerns about the US Consumer Product Safety 
Improvement Act of 2008.  While China supported the objective of protecting consumer safety by 
developing new technical regulations, it was concer ned about a possible violation of TBT obligations, 
both with respect to the regulation itself and to th e process through which it had been developed.  He 
stressed that the Act could have a significant effect  on trade and that it should  be notified to the WTO 
in the draft stage to allow for comments,  which needed to be taken into account. 
5. The representative of China furthe r noted that the Act required that total limits of lead in 
products should be reduced from 600 ppm to 100 ppm within 3 years.  However, the total lead content 
included both soluble and insoluble lead.  Insoluble lead, as it could not be absorbed, was not harmful 
to human health.  Therefore, setting limits on to tal lead content would create an unnecessary obstacle 
to international trade and would violate the least tr ade-restrictive principle of the TBT Agreement.  
Other provisions in the Act could also have a signifi cant effect on trade, for example those related to 
the criteria for accreditation of third party certificat ion bodies.  He requested the United States to 
notify the Act and to take comments into account. 
6. The representative of the United States  noted that the document G/TBT/N/USA/421 
contained the notification of the first of sever al implementing measures of the Consumer Product 
Safety Improvement Act of 2008.  He explained that the Consumer Product Safety Improvement Act - 
also known as CPSIA – had been signed into law in August 2008.  CPSIA gave the US Consumer 
Product Safety Commission (CPSC) new regulatory aut hority and enforcement tools to protect public 
health and safety.  Specifically, CPSIA contained several provisions designed to strengthen protection 
against unsafe products intended for children's use.  He  noted that, reflecting the need for suppliers to 
adjust to the new measure, many of the requirements contained in the CPSIA would be introduced and 
implemented on a rolling basis over the coming year.  
                                                      
2 Regularly updated information on Members' enquiry points is also available on the WTO TBT 
webpage: http://www.wto.org/english/trat op_e/tbt_e/tbt_enquiry_points_e.htm.  G/TBT/M/46 
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  7. The representative of the United States further point ed out that the notification referred to the 
implementing measures relating to third-party tes ting for children's products, as well as establishing 
accreditation requirements for independent third-party t esting facilities to test for conformity with the 
new maximum lead-paint levels set by the Act.  Additional implementing measures, including for 
small parts, cribs, and other CPSIA requirements,  would be developed and published according to the 
timetable laid out in the statute and would be no tified to the WTO.  Given the seriousness of the 
public health incidents, there had been stro ng support in the US Congress for expedited 
implementation of some measures.  Therefore, on lead and other issues, Congress had directed CPSC 
to implement on a very short timetable.  
8. It was further explained that, under US law, every manufacturer of a product subject to a 
consumer product safety regulation enforced by CP SC was required to certify that the product was 
compliant through a supplier's declaration of confor mity (SDoC).  SDoC had been recognized by the 
TBT Committee as the most trade facilitating of all conformity assessment procedures.  For those products intended for children, CPSIA mandated that  each manufacturer would also have its products 
tested by an accredited independent testing laborat ory.  Based on that testing, the manufacturer 
certified that the product met all applicable C PSC requirements and also specified the accredited 
laboratory that had performed the testing.  It w as noted that laboratories operating anywhere in the 
world could be accredited, and that the current list of accredited labs was posted on the CPSC 
website.
3  
9. Furthermore, it was noted that under the Act, CPSC  was given the authority to either accredit 
laboratories for doing the required testing of chil dren's products, or to designate accreditation bodies 
to accredit testing laboratories.  CPSIA also containe d special provisions to ensure that laboratories 
controlled by the manufacturers of children's product and government-owed laboratories were 
properly "firewalled" to ensure strict standards of independence and no undue influence.  CPSC's 
implementing rules on accreditation relied on the existi ng international technical infrastructure.  For 
example, ISO 17025 accreditation by an ILAC-MRA accrediting body would serve as the baseline 
criterion for CPSC acceptance of any laboratory - whether a commercial thir d party, a government 
laboratory, or a manufacturer-owned laboratory.  
10. Finally, the representative of the United States stressed that CPSC had made many efforts 
during the development of this legislation to reac h out to the key trading partners to ensure full 
understanding of its provisions, and that it stood read y to engage with any government laboratory to 
work through issues related to  the additional criteria.  
(ii) European Communities - Proposal for a Regulatio n of the European Parliament and of the 
Council on Cosmetic Products (G/TBT/N/EEC/186 and Corr.1) 
11. The representative of China  noted that, while his delegation understood the objective of 
protecting human health, there was concerned about possible inconsistencies of the notified measure 
with the TBT Agreement. Written comments had been sent to the European Communities and a 
written reply had been received.  However, the repl y had not fully addressed the concerns expressed.  
First, Article 10 of the draft regulation prescribed the information that should be submitted by the 
supplier prior to placing cosmetic products on the market.  The European Communities had replied 
that it aimed at giving relevant information to the member States’ authorities and anti-poison centres in case of necessity.  However, his delegation believe d that the required information was not related to 
cosmetic safety and that it would significantly increas e costs for manufacturers.  He requested that the 
scope of the information to be subm itted be limited to product safety a nd that the least trade restrictive 
obligation of the TBT Agreement be fulfilled.  
                                                     
 
3 www.cpcs.gov  G/TBT/M/46 
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  12. Second, the draft regulation stipulated that “with  regard to substances which are classified as 
CMR1 or 2 substances [carcinogenic, mutagenic and reprotoxic substanc es], there should be a 
possibility to use such substances in cosmetic produc ts if such use has been found safe by the SCCP.  
Such substances should be continuously reviewed by the SCCP [the Scientific Committee on 
Cosmetic Products]".  The representative of China stressed that, according to Article 6.1 and 6.2 of 
the TBT Agreement, test data and results issued  by laboratories which had been approved by the 
accreditation bodies of other Members such as China s hould also be accepted.  Finally, he sought an 
update on the status of the proposed regulation, in particular with respect to the time of adoption and 
to whether Members’ comments could still be taken into account. 
13. The representative of the European Communities
 recalled that comments from China on the 
EC notification had been received in March 2008 a nd a comprehensive reply had been provided on 
1 August 2008.  She pointed out that the notified proposal consisted of a codification and recast of 
Council Directive 76/768/EEC relating to cosmetic  products and the 55 subsequent directives 
amending this Directive.  The codification and the recast version was done in order to improve clarity 
and legal certainty for cosmetic products.  The c oncept of cosmetic product safety assessment was not 
new in the European Communities.  The current cosm etic directive already contained the requirement 
to undertake such an assessment prior to the placing on the market of the product.  However, the 
information to be contained in this safety assessment  had never been specified.  A crucial element of 
the recast was the clarification a bout the information that had to be  contained in the cosmetic product 
safety assessment.  This would provide evidence of the safety of the cosmetic product placed on the 
market and also help member States carry out thei r market surveillance, thus contributing to legal 
certainty. 
14. With respect to the substances whose use was banned or restricted, the representative of the 
European Communities stressed that  these substances had been assessed  by the Scientific Committee 
for Consumer Protection, an independent scientific body advising the European Commission.  Most of 
the scientific opinions at the origin of the restrictions could be found on the publicly available database on the internet site of DG Enterpri se and Industry of the European Commission.
4  Finally, 
she informed the Committee that  the proposed regulation had not been adopted and that it was 
undergoing its first reading in the European Parliament and in the Council. 
(iii) China - Brake linings for automobiles (G/TBT/N/CHN/366 and Suppl.1) 
15. The representative of the European Communities  raised concerns about the above-mentioned 
measure, which laid down mandatory requirements fo r brake lining of cars.  Her delegation had sent 
comments to China seeking clarification of the scope of  the measure, in particular if the draft applied 
only to replacement brake linings or also to brake lini ngs which were part of the original vehicle.  Her 
delegation considered that brake lin ings which were part of the original vehicle or replacement brake 
linings which were identical to the original linings  used on the vehicle should not be covered by the 
measure.  These brake linings had already been check ed at the time of the type-approval of the whole 
brake system and there would therefore be an unnecessary duplication of checks.   
16. The representative of China  noted that his delegation had fulfilled the transparency 
obligations by notifying the draft measure and providing a comment period of sixty days.  A reply to 
the comments sent by the European Communities would be provided through the Enquiry Point. 
(iv) United States – Olive Oil (G/TBT/N/USA/395) 
17. The representative of th e European Communities  referred to the proposed revision of the US 
standards for grades of olive oil and olive pomace oil.  Written comments had been submitted to the 
                                                      
4 http://ec.europa.eu/enterprise/  .  G/TBT/M/46 
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  United States, which pointed out that some of the it ems covered by the proposed standards, such as 
aspect, colour, odour and flavour were requirements or  limits of certain chemical components in the 
oil were not in line with the Codex standards for olive oil and olive pomace oils.  She invited the 
United States to provide a written reply to the co mments and looked forward to continued discussion 
on this issue. 
18. The representative of the United States  noted that the proposed grade standards for olive oil 
and olive pomace oil had been notified on 4 June 2008 and that the final date for comments was 
1 August 2008.  Comments had been received from dom estic and foreign producers, consumers, trade 
associations, and government agencies.  All comment s on the proposed standard s were in the process 
of being evaluated by the USDA Agricultural Marke ting Service (AMS).  Upon completion of this 
review, AMS would draft and publish final standards which would expl ain the consideration given to 
each of the comments received.  
19. The representative of the United States further noted that the use of these standards was 
voluntary, as indicated in the Federal Register notice of 2 June 2008. Further, the proposed parameters 
for linolenic acid and campesterol were more lib eral than the International Olive Council (IOC) 
standard, so it was difficult to understand how the US standards could inhibit trade.  In terms of the 
substance, the Unites States believed that the pr oposed standards were in  accordance with current 
international guidance from Codex relating to specif ic levels of fatty acid composition of linolenic 
acid.  The Codex Standard5 for olive oils and olive pomace oils specifically stated that, pending 
further discussion by the Codex Committee on Fats and Oils, national limits could remain in place for 
linolenic acid. 
20. Moreover, the representative of the United Stat es pointed out that IOC was not recognized as 
a technical expert body by Codex, but as a N on-Governmental Organization (NGO) with observer 
status.  His delegation believed that current IOC grading standards for fatty acid composition were 
flawed in that they did not account for fundamental climatic and geographical factors that could affect 
key components of fatty acid and sterol composition such as linolenic acid and campesterol.  The IOC 
levels were based on historical data from Europe that did not account for agro-climactic conditions in 
other regions of the world that caused certain components of olive oil to vary from region-to-region.  If compliance with the IOC standards were mandated, th is would restrict global trade in olive oil since 
only olive oil from the European Communities would qualify.  He stressed that the IOC grading 
standard reflected input exclusively from its me mbers in European and Mediterranean countries.  
Therefore, it was no coincidence that the government s of Argentina, Australia, and New Zealand, as 
well as industry groups from Aust ralia and Argentina, had provide d written comments in support of 
the proposed US standards, which took into account th at olive oil was not produced in only one region 
of the world. 
(v) European Communities – Napropamide (G/TBT/N/EEC/203) 
21. The representative of India
 raised concerns about the non-inclusion of napropamide in 
Annex 1 of Council Directive 91/414/ EEC and about the withdrawal of the authorization for plant 
protection products containing this substance.  I ndian industry believed that the measure was not 
based on concrete scientific evidence and on an ap propriate risk assessment.  He stressed that the 
Indian industry had provided all available scientific findings in favour of incl usion of napropamide in 
Annex 1 for continued authorization of plant protecti on products containing this substance.  He noted 
that, while Denmark had accepted these finding, they ha d not been duly considered in the report of the 
European Communities Food Safety Authority.  His delegation believed that this measure was more 
trade restrictive than necessary and thus in c ontravention of the basic principles of the TBT 
                                                      
5 Codex Stan 33-1981 (rev. 2-2003)1 G/TBT/M/46 
Page 6  
 
  Agreement.  He urged the European Communities to  examine this issue and to reconsider the non-
inclusion of napropamide in Annex 1 of the Council Directive 91/414/EEC. 
22. The representative of the European Communities
 noted that a response had been sent to the 
Indian Enquiry Point.  If further clarification was necessary, this could be pursued bilaterally. 
(vi) United States – Detection of contaminants in fuel containers 
23. The representative of India  raised a concern with respect to the detection of contamination in 
fuel containers of casting and fe ncing material being exported from India to the United States.  The 
contamination was said to be caused by Cobalt 60, an isotope causing radiation in stainless steel 
capsules.  As a result, all exports of steel and ca stings from India were currently being checked for 
contamination.  He pointed out that the main pr oblem was that there was no tolerance limit supplied 
by the United States for contamination of Cobalt 60 .  His delegation's understanding was that there 
was no international standards in this area.  In th e absence of an international standard, how did the 
United States fix the tolerance limit at zero?  Indi an industry believed that the zero limit was more 
trade restrictive than necessary and t hus against the basic principle of the TBT Agreement.  He invited 
the United States to provide a risk  assessment to justify the limit. 
24. The representative of the United States  stated that further clarification from India was needed 
before his delegation could provide a response.  He also noted that the fact that there was no 
international standard on a particular matter did not mean that Members could not regulate. 
(vii) European Communities – Novel foods (G/TBT/N/EEC/188) 
25. The representative of Colombia  introduced his delegation's concerns with respect to the EC 
measure on novel foods (circulated as docum ent G/TBT/W/298, dated 4 November 2008). 
26. The representative of Ecuador  shared Colombia's concerns.  While his delegation recognized 
the effort made by the European Communities to take into account in terests of Andean countries and 
other developing countries, concerns remained about the current regulation.  For example, clarity was 
needed on what constituted a "generation" as well  as on other matters, such as the limitation to 
commercial operators.  He stressed that data on the safe use of foods varied in different countries and 
that data protection should not be included in this legislation.  He urged the European Communities to 
take into account the interests and requests of th e Andean countries expressed on various occasions, in 
particular during the revision of the legislati on which was being carried out by the European 
Parliament. 
27. The representative of Peru  shared the concerns expressed by Colombia and Ecuador regarding 
the amendment of the regulation on novel foods, an d noted that his delegation had expressed concerns 
at the last meeting of the SPS Committee.  Peruvian  authorities had also received a response from the 
European Communities to the concerns  expressed, which was being examined. 
28. The representative of Mexico  shared the views expressed and noted that his delegation had 
raised concerns about this measure in the SPS Committee. 
29. The representative of Costa Rica  supported the comments made by previous delegations and 
also noted that concerns had been expressed by his delegation in the SPS Committee, and that the 
matter would be raised again in that Committee. 
30. The representative of the European Communities  explained that the European Communities 
had launched a revision of the nove l food legislation with a view to simplifying it and facilitating 
market access for third country operators by provi ding a centralized risk assessment, an authorization  G/TBT/M/46 
 Page 7 
 
 
  framework and strict timelines for the authorization pr ocedure.  With respect to the new procedure for 
the authorization of traditional food, she inform ed the Committee that the novel food regulation was 
being discussed in the European Parlia ment as well as in the Council.   
31. With respect to some specific i ssues raised, for example the definition of "traditional food" or 
of "generation", the representative of the Europ ean Communities pointed ou t that these would be 
defined in the implementing rules which had not yet been elaborated.  Comments would be taken into 
account when these implementing rules were prepared.  In addition, technical guidance would also be 
developed to assist food business opera tors and other interested par ties, in particular small and 
medium sized enterprises, when submitting an app lication.  Although time for comments had elapsed, 
she encouraged interested delegations to submit co mments in writing to the EC Enquiry Point so that 
they could be taken into account. 
(viii) Chinese Taipei – Green Mark Products 
32. The representative of Japan  raised concerns about Chinese Taipei's green mark products.  He 
pointed out that there was no perfect method of ex cluding lead from foreign materials in additives, 
paint and degradation control agents.  Regulations concerned, such as the Restriction of Hazardous 
Substances (RoHS) in other countries, including EC me mber States, set lead reference values at 1,000 
mg/kg.  However, Chinese Taipei's green mark regul ation set its lead reference value in industrial 
products at 2mg/kg;  many products were not able to  meet this standard.  In some cases industrial 
products had been forced to undergo multiple examina tions.  It was his delegation's request that these 
reference values be promptly amended. 
33. The representative of Chinese Taipei  stressed that the green mark regulation was different 
from RoHS, and that applying for a green mark was a voluntary practice.  There was no zero tolerance 
provision.  She noted that the issue coul d be discussed with Japan bilaterally.  
(ix) United States – Requirements to combat illegal logging (G/TBT/N/USA/424 and Corr.1) 
34. The representative of the European Communities  noted that the notified measure established 
new requirements to combat illegal logging;  it was an amendment to the Lacey Act that had been 
included in the 2008 Farm Bill and which had been recently approved by the United States Congress.  
The new measures, which would come into force in  April 2009, required the submission of an import 
declaration for most plant and plant-related pr oducts.  The import declaration would include, inter 
alia, information on the plant species, country of harvest, value of importation or quantity of the plant 
used.  The Animal and Plant Health Inspection Se rvice of the US Department of Agriculture had 
launched a public consultation on these new measures,  inviting interested stakeholders to submit 
comments by 8 December 2008.  
35. While the European Communities shared the US commitment to fight illegal logging, concern 
was expressed with regard to the potential negativ e impact on EC exports to the United States.  The 
new measures could potentially impact a wide ra nge of products.  Detailed comments would be 
transmitted within the framework of the consultation that was launched in the Federal Register.  The 
United States were urged to take the comment s into account in the ongoing discussions on this 
proposal. 
36. The representative of Argentina  shared the concerns expressed.  He pointed out that the new 
measures required an import license for plant pr oducts and products derived from plant species 
including sports products, musical instruments, furniture, textiles and manufactured products made 
from plant resin.  It was his delegation's view that the regulation was not necessarily intended to 
protect endangered species but rather to  protect domestic markets from imports. G/TBT/M/46 
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  37. The representative of Canada
 shared some of the concerns expressed and noted that 
comments would be submitted to the Untied States. 
38. The representative of Switzerland  echoed the views expressed and noted that comments 
would be submitted.  She stressed that the scope of the products that would require a declaration 
under the Lacey Act was very broad and that  it only applied to imported products.  
39. The representative of the United States  explained that the Lacey Act had initially been signed 
into law in 1900 and that it was the United States' oldest national wildlife protection statute, which 
had served as an anti-trafficking statute protecting a broad range of wildlife and wild plants.  The 
Lacey Act was amended with the passage of the 20 08 Farm Bill and the purpose of the amendment 
was to combat illegal logging and to expand the L acey Act anti-trafficking protections.  While his 
delegation understood Member s' concerns, he noted that the United States and other countries shared 
a desire to assist countries in combating illegal logging and associated trade, and the amended Lacey 
Act provided a new tool for that effort.  
40. The representative of the United States furthe r pointed out that any actions taken to 
implement the amended Lacey Act would be done in a manner consistent with the US international 
trade obligations.  The careful and measured appr oach to implementation that the United States was 
taking would demonstrate that the planned import declaration would be de veloped and implemented 
so as not to be an undue burden.  His delegation was actively engaged in consultations with a wide 
range of stakeholders regarding all aspects of impl ementation.  Particular attention was put on the 
declaration and the plan for phased-in enforcement.  He drew the Committee's attention to the fact that 
the requirement to file the declaration would not be immediately enforced and that implementation 
would begin no earlier than 1 April 2009.  In add ition, there would be a phased-in approach over time 
to enforcing declaration requirements, with an initia l focus on products more closely linked to illegal 
logging.  When in force, the declaration would not  require information on legality, but would require 
information on the country where the plant material was harvested.  
41. Finally, the representative of the United States noted that a Corrigendum to the original 
notification had been submitted to clarify a few poi nts, in particular that the measure was not a 
technical regulation, and to inform about th e delay in the enforcement of the measure.  
(x) Korea – Import Review Process for Functional Cosmetics 
42. The representative of the United States  raised a concern regard ing Korea's import review 
process for functional cosmetics.  He pointed out that the applicable Korea Food and Drug Administration (KFDA) regulations appeared to trea t imports differently than  domestic products in at 
least two significant areas.   The first was the quality testing process.  While domestic companies 
could combine their internal quality tests with the KFDA-mandated tests, importers had to test their 
active ingredients in Korea in order to get KFDA  approval, in addition to their internal quality 
controls.  He further noted that, in addition to  the KFDA approval process, there was a requirement 
for the final product - a sample of every imported batc h, even different colours of the same product - 
to undergo a second round of testing in Korea before  being allowed to be sold.  This second round of 
testing imposed significant costs on importers that  their domestic counterparts were not burdened 
with, and should be abolished.  
43. The second area where Korea appeared to treat imports differently th an domestic products 
was the involvement of the Korean Pharmaceu tical Trade Association (KPTA) in the customs 
clearance process.  It was the United States' unders tanding that, as part of an agreement Korea had 
recently reached with the European Communities, importers would no longe r have to submit the 
quantitative detailed formulas of their products to KPTA.  The United States welcomed and 
appreciated this as a positive step and expected that this would apply to all Korea's trading partners.   G/TBT/M/46 
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  However, from the US perspective, the entire st ep of reporting information to the KPTA was 
redundant, unnecessary, and subjected imports to a requirement that domestic products were not 
affected by.  Only importers needed to go throu gh the step of having the KPTA review and approve 
their documentation - ingredients, product names,  product classification - in order to sell their 
products in Korea.  KPTA could hold up the en tire customs clearance process while it asked for 
supplementary information.  
44. The representative of the United States also recalled that concerns had been raised in the past 
about Korea's implementation of its requirement for exporters to  submit proprietary business 
information to KPTA, a private association compri sed of the companies that US companies were 
competing against in the marketplace, without pr oviding for adequate pena lties and enforcement for 
disclosure of proprietary information.  He urged Ko rea to give consideration to abolishing the Korean 
Industry Association involvement in the process of  bringing imported cosmetics to the Korean 
market.  Finally, he noted that bilateral discu ssions had recently taken place and understood that 
Korea was reviewing the measure:  his delegation looked forward to continued discussions with 
Korea in the context of that review. 
45. The representative of Korea  pointed out that there was no discrimination between importers 
and domestic manufacturers regarding conformity assessment procedures.  With respect to the inspection for domestic manufacturers, there were numerous inspection procedures, including during 
the manufacturing phase.  In terms of confidentiality,  according to internal regulations of the KPTA, 
there was a strong protection clause order to protect  confidential commercial information.  He took 
note of the concerns expressed by the United States  and stated that bilateral discussions could be 
intensified in order to accommodate these concerns.  
(xi) European Communities – Dangerous Chemical  Substances; Draft Commission Directive 
amending, for the 31
st time, Council Directive 67/548/EEC (G/TBT/N/EEC/212) 
46. The representative of Canada  raised concerns about a draft regulation on the 31st Adaptation 
to Technical Progress (ATP) to the Dangerous S ubstance Directive 67/548/EEC (G/TBT/N/EEC/212).  
Her delegation regretted that, despite the previ ous commitments to review the classification and 
labelling of nickel substances in light of any new relevant scientific findings or interpretations, the 
European Communities had not take into account the concerns expressed by industry and trading 
partners.  In particular, although industry str essed that the proposed classification for nickel 
carbonates was not based on sound scientific analysis under the 30th ATP, the European Communities 
decided to classify more than one hundred nickel substances under the 31st ATP using mainly the 
same data.  With the implementation of this propos al, nickel substances would be treated as proven 
human carcinogens, and many of them would also be classified as reproductive toxicants and mutagens, among other hazards.   
47. The Canadian representative stressed that her delegation was not taking a position on the 
toxicity or carcinogenicity of particular nickel-based  substances; rather, there were concerns that the 
issues raised by industry had not been taken in to account nor had sufficient time to conduct the 
necessary research been given.  Some  other specific concerns on the 31
st ATP were raised by his 
delegation.  First, Australian officials and the ni ckel industry had pointed out that water solubility, 
which the European Commission relied on, was not suffi cient to delineate a category for read-across.  
Second, Canadian industry had expressed concern that water solubility was not a predictor of 
bioavailability.  Third, industry was concerned th at the European Communities' reliance on "expert 
judgement" as part of the OECD read-acro ss methodology was flawed because the supporting 
information for the "expert judgement" had never b een made available.  The European Communities 
was therefore requested to provide the full suppor ting information for its "expert  judgement".   G/TBT/M/46 
Page 10  
 
  48. Furthermore, Canada had been informed th at the European Communities had scheduled a 
meeting of the Technical Progress Committee (TPC ) on 19 November 2008, in which EC member 
States would be asked to vote on the 31
st ATP.  In this regard, the representative of Canada asked the 
European Communities to confirm the date of this me eting and explain how they  planned to take into 
account the comments submitted by trading partne rs, given that the comment period for this 
notification closed on 18 November 2008.  Finally,  the representative of Canada encouraged the 
European Communities to identify th e downstream consequences of its proposed technical regulation.  
She reiterated concern that the European Comm unities would use the same methodology as a model 
for future classifications of other substances under REACH.   
49. Canada exported over US$8 billion worth of nick el and nickel substances to the European 
Communities each year.  It was therefore critical that  any restrictions imposed on nickel substances be 
based on sound science and did not represent an unneces sary barrier to trade.  The representative of 
Canada requested that the 31st ATP be withdrawn, and that the de lay in adoption allow sufficient time 
for information submitted by industry to be properl y considered.  Alternatively, Canada urged the 
European Communities to remove all nickel classification proposals in the 31st ATP and allow nickel 
classification to proceed under REACH. 
50. The representative of Cuba  was concerned that the Europ ean Communities proceeded with 
the 31st ATP in spite of the considerable criticism directed at the 30th ATP on account of the 
read-across methodology, which was again being u sed as the basis for clas sifying more than one 
hundred nickel compounds.6  It was also recalled that communications regarding these classifications 
had been sent to various European Commission au thorities in Brussels by the ACP Group and by a 
group of developing countries in conjunction with other developed countries in February and March 
2008, respectively, as well as in a further letter sent by the ACP Group at the end of October. 
51. The Cuban representative pointed out that the technical consultation held on 4 November 
2008 by the European Communities w as considered by Cuba to be a somewhat tardy endeavour.  
Given the complexity of this issue, the consulta tion should have taken place earlier and indeed several 
such consultations should have been held.  More over, the European Communities' responses at that 
consultation were not considered convincing.  In pa rticular, it was noted that not a single scientific 
publication had been mentioned or distributed, no r was there mention of any research centre or 
researcher in a position to back up the European  Communities' theories about the classification of 
nickel compounds.  In this regard, Article 2.2 of  the TBT Agreement provided that "in assessing such 
risks, relevant elements of consideration are, inter alia:   available scientific and technical information, 
related processing technology or intended end-uses of products".   
52. The Cuban delegation also noted that, at the above-mentioned consultation, the EC had asked 
the Members about the implications for and im pact upon their countries and industries of the 
Dangerous Chemical Substances Directive.  These were precisely key factors which the European 
Communities should have ascertained and assessed when developing the draft Directive.  In this 
regard, the representative of Cuba drew the Co mmittee's attention to Article 2.2 of the TBT 
Agreement, which also provided that "Members sh all ensure that technical regulations are not 
prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to 
international trade.  For this purpose, technical re gulations shall not be more trade-restrictive than 
necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create". 
53. The European Communities was reque sted to take into considera tion Article 12.3 of the TBT 
Agreement, which provided that "Members shall, in  the preparation and application of technical 
regulations, standards and conformity assessment procedures, take account of the special 
                                                      
6 A communication setting out the details of Cuba's concerns was subsequently circulated in document 
G/TBT/W/301.  G/TBT/M/46 
 Page 11 
 
 
  development, financial and trade needs of developing  country Members, with a view to ensuring that 
such technical regulations, standards and conformity assessment procedures do not create unnecessary obstacles to exports from developing country Member s".  In fact, it was stressed that the adverse 
effects of the new classifications on the nickel industry were incalculable and would have repercussions on other industries which use nickel  and nickel compounds, such as steel, stainless 
steel, surface treatment, batteries, nanotechnologi es, the automotive, aviation and electronics 
industries.  The impact of these classifications woul d also be felt by other industries which use nickel 
substances for other industrial or chemical processes as catalysts in oil refining, food processing and 
hydro cracking. 
54. The representative of Cuba pointed out that  the reclassification of these substances would 
have consequences for their labelling, packaging, transport and handling.  At the same time, the 
reclassification of nickel on one of the largest and most important world nickel markets would affect 
the access of nickel and nickel products not merely to  that market, but also to other major markets, 
given that it would not be long before a domino ef fect would see other major markets adopting this 
classification, as had been the case previously with other standards and classifications.  It was his 
delegation's understanding that such consequences would result in substantial costs for a large group 
of developing countries, including a number of LD Cs and African countries which were amongst the 
poorest in the world, as well as Latin American and As ian countries.  In particular, they would be 
required to set up special and costly storage and handling facilities to improve worker protection and 
safety, and to pay higher wages at both the productio n, storage and transport stages and in the end-use 
industries.  All as a result of purported risks whic h, in the Cuban delegation's opinion, had not been 
scientifically proven. 
55. The Cuban representative also stressed that th e reclassification of nickel substances was 
taking place in the context of a financial crisis wh ich was affecting developing countries, and which 
had led to a global contraction of credit and investme nt.  In this regard, such classification of nickel 
substances as Category I carcinogen would trigger a contraction in demand and investment in this 
industry and an increase in production,  transport and insurance costs.  It was also recalled that the 
international price of nickel, which climbed to mo re than US$50,000 per ton had fallen to just above 
US$8,500 per tonne.  Given the speculative nature of  the markets for commodi ties such as nickel and 
their sensitivity to factors such as new standards, it could not be ruled out that the process related to 
the 31
st ATP was one of the factors that brought about the drop in nickel prices.  Again, the 
representative of Cuba highlighted that these adve rse effects would be particularly severe for 
developing countries which, given their low levels of development and industr ialization, relied on a 
few export products for employment and revenue .  The Cuban economy would be significantly 
affected by this measure given that it possessed one of  the world's largest reserves of nickel and that 
nickel constituted the countr y's main export product. 
56. The representative of Cuba considered the 31st ATP as an unnecessary obstacle to trade and 
therefore inconsistent with Article 2.2 of the TBT Agreement.  He drew the Committee's attention to 
the fact that the read-across methodology consiste d of predicting adverse effects on environment and 
health from chemical substances for which no toxic ity data existed, by comparing them with other 
substances with similar structures or properties for which information did exist.  In particular, the 
European Communities was trying to establish a similarity between one hundred nickel compounds 
and nickel carbonates on the basis of a comparison of  their water solubility.  The representative of 
Cuba pointed out that the same substance bei ng used as a reference was already incorrectly 
reclassified as dangerous, using the same method without any scientific underpinning. 
57. He further stressed that a number of specialized  bodies, such as the Nickel Institute, stated 
that the comparison methodology used by the Eu ropean Communities did not follow either the 
guidelines established by the OECD or the criteria of the US Environmental Protection Agency (US 
EPA), on the basis of which such methodology was developed.  This was due to the fact that the G/TBT/M/46 
Page 12  
 
  European Communities disregarded three of the ei ght essential verification steps established by the 
OECD guidelines, without providing any explanation as to why those steps were omitted.  The European Communities asserted that this procedure was justified by "expert criteria", but contrary to 
the OECD guidelines, US EPA practice and even Eur opean Community legislation itself, the data on 
which the "expert criteria" was based had not been furnished.  Moreover, for both the OECD and the 
US EPA, establishing categories or groups of chemicals for the purpose of this methodology was a 
complex process involving the review of a number of elements.  One of the many physico-chemical properties to be considered when making the comp arison was water solubility.  Far from taking the 
entire range of factors established in the OECD  guidelines into consideration, the European 
Communities restricted itself almost exclusively to the least appropriate one, if account was taken of 
the fact that no data existed on the water solubility for most of the nickel compounds that were 
classified in the 31
st ATP.  The representative of Cuba also recalled that it was scientifically 
demonstrated that water solubility was not a pr operty which determined whether nickel compounds 
were soluble in biological fluids, given that solubility varies widely from one fluid to another. 
58. Cuba raised five specific questions in respect  of the above.  First, could the European 
Communities explain how water solubility was used as  the key factor for grouping nickel substances, 
when there was no available data on the water so lubility for most of the nickel compounds which 
were classified in the 31st ATP?  Second, data existed which i ndicated that the solubility of nickel 
compounds in water was not the same as solubility in  body fluids and that the solubility of nickel 
substances in human body fluids varied.  Could th e European Communities provide data or scientific 
studies which provide evidence to the contrary?  Third, could the European Communities provide 
scientific evidence from published studies which prove that water solubility predict the bioavailability 
of the nickel ion in the cells of human organs?  Fourth, could the European Communities provide a 
detailed explanation, on the basis of published studies,  of the scientific criteria and data supporting the 
conclusion that because one substance is carcinogenic a nother, different substance, also had to be?  
Fifth, could the European Communities make availabl e its evaluation, or documented evidence, of the 
risks of exposure from normal and expected use of the nickel compounds classified in the 31st ATP? 
59. In addition to the lack of scientific consistenc y, the representative of Cuba drew the attention 
of the Committee to the timetable established by the European Communities for the adoption of the 
31st ATP.  Cuba considered that the European  Communities was not allowing enough time for 
Members to submit comments and for consultations to be held.  Nor was this period sufficient for the 
European Communities to review and take into account these comments, as required under Article 
2.9.4. of the TBT Agreement.  Moreover the d eadline also precluded any possibility of in-depth 
discussions being held within the Committee, as requi red under Article 2.9 of the TBT Agreement.   
60. The representative of Cuba was particularly c oncerned by information according to which the 
European Communities would organize a vote within the Technical Progress Committee on 19 November, two weeks after the TBT Committee m eeting and one day after the deadline of the 
comment period.  Considering that after this vote amendments to the 31
st ATP would be virtually 
impossible, the European Communities was requested to explain how they planned to study, take 
account of comments and, if necessary, amend the 31st ATP Directive within 24 hours of the end of 
the notification comment period.  Finally, the representative of Cuba requested the European 
Communities to take into account the concerns and comments expressed by developed and developing 
countries, and amend the draft regulation to ex clude nickel compounds from the scope of its 
application.  Cuba also requested the extension of the comment period, by at least sixty days, in order 
to enable Members to submit comments and further bilateral and multilateral consultations be held. 
61. The representative of China  shared the comments expressed by the delegations of Cuba and 
Canada.  While China appreciated the sixty day period provided for comments on the notification of the 31
st ATP, it was recalled that the proposed regulation was highly technical, covering over six 
hundred chemicals and more than one hundred nick el compounds.  The European Communities was  G/TBT/M/46 
 Page 13 
 
 
  therefore encouraged to extend the deadline for su bmitting comments, in order to give Members the 
possibility to carefully evaluate the proposed regula tion.  In this regard, the representative of China 
drew the Committee's attention to Article 2.9.4 of  the TBT Agreement, which provides that "Members 
shall without discrimination, allow reasonable time for other Members to make comments in writing, discuss these comments upon request, and take th ese written comments and the results of these 
discussion into account".  Also, China had been informed that the Eu ropean Communities had 
scheduled a meeting of the Technical Progr ess Committee on 17 November 2008, in which EC 
member States would be asked to vote on the 31
st ATP.  In this regard, the representative of China 
requested the European Communities to clarify how they planned to take into account the comments 
submitted by trading partners, given that Member s were still formulating their comments on this 
notification.  Since his delegation considered this to be inconsistent with Article 2.9.4 of the TBT 
Agreement, the European Communities was requested  not to vote on the notified draft regulation 
before giving full consideration to Members' comments and concerns.   
62. The representative of China noted that using wa ter solubility as the only scientific information 
and read-across as the methodology to classify  over one hundred nickel compounds was not 
scientifically correct.  In fact, it was his delegation' s opinion that classification of substances could not 
be based on one single factor but other factors, such as structure and physicochemical nature, had to be taken into account.  China added that the Eur opean Communities did not provide any specific data 
on the water solubility of most nickel compounds. The Chinese representative also pointed out that 
the European Communities did not follow all th e necessary steps in the OECD read-across 
methodology for substance classification.  The Eur opean Communities missed three specific steps: 
"prepare category test plan", "conduct necessary tes ting", "perform an external assessment of the 
category and fill data gaps".  It was also highlig hted that from existing scientific data and risk 
assessment reports on some substances, read-across classifications based on water solubility appeared 
to differ from those based on scientific documents.  Therefore, China believed that the read-across 
methodology based on water solubility was not a sci entific method.  Finally, China invited the 
European Communities to explain the justification fo r the draft regulation according to Article 2.5 of 
the TBT Agreement, and reconsider the classification and labelling of nickel compounds under the 31st ATP. 
63. The representative of Ecuador, speaking on behalf of GRULAC
 recalled that, on 12 March 
2008, a letter regarding the proposed reclassificatio ns of numerous nickel substances under the 30th 
and 31st ATP had been sent to the European Commissi oners for Enterprise and Industry, Environment 
and External Trade by some Members of the Group of Latin and Caribbean Countries (GRULAC).  In 
this letter, the European Communities was spec ifically requested not to proceed with the 
reclassification of nickel substances under the 30th and 31st ATP and allow sufficient time for 
scientific information submitted by industry to be properly considered.  His delegation regretted that 
the European Communities had adopted the 30th ATP without taking into account the concerns 
previously expressed by Members of the TBT Committee, and feared that the 31st ATP would follow 
the same fate.  Ecuador stressed that both the 30th and 31st ATP were of concern to Members that 
produced nickel, that manufactured goods using ni ckel compounds or used them in other industrial 
and chemical processes.  It was recalled that the pr oposed reclassification of nickel substances would 
negatively affect the trade, economic growth and development of many GRULAC's members. 
64. The representative of Ecuador pointed out that the 31st ATP was not consistent with the 
provisions of the TBT Agreement.  Furthermore, these Directives created concerns for other mineral 
and substances producers in the Latin America a nd the Caribbean region, because the approach 
followed by the European Communities in the app lication of the read-across methodology in the 31st 
ATP would likely set a negative precedent for regulating other substances under REACH.  While 
members of GRULAC recognized the need for author ities to regulate the use of dangerous substances 
for protecting human health and environment, it was noted that the read-across methodology had to be 
used in a scientifically sound manner in orde r to avoid unnecessary barriers to trade.   G/TBT/M/46 
Page 14  
 
  65. Ecuador was also concerned that, despite the efforts of some GRULAC members, no 
clarifications on the science and data used to formulate the 31
st ATP had been received from the 
European Commission.  While the 31st ATP relied only on water solubility for defining groups of 
similar nickel substances, the read-across method was a complex process that involved reviewing a number of inputs, not only a single variable.  Concer ns remained that there was no data on the water 
solubility for most of the nickel compounds, that ex isting data on water solubility for some nickel 
compounds varied from one substance to the other, a nd that water solubility was not a predictor of the 
solubility of nickel compounds in biological fluids.  Moreover, there were no scientific information on 
toxicological effects for most of nickel substances or  scientific information that nickel substances with 
similar water solubility would cause similar toxicological effects.   
66. The European Commission was therefore encourag ed to take into consideration the demands 
of transparent and scientific data as basis for any future reclassification of nickel or any other substances.  GRULAC members further requested that  any regulatory measure that had a large impact 
on international trade be no more trade restrictive th an necessary.  Finally, the European Communities 
was urged to take into account the concerns and objections raised by WTO Members and remove all 
nickel classification proposals in the 31
st ATP. 
67. The representative of Colombia  associated his delegation with comments made by Ecuador.7  
Colombia was particularly concerned that the fina l date for comments established by the European 
Communities was restricted to sixty days from the date of notification.  This period of time was insufficient for Members to exercise their rights, especially since the issue addressed by the draft 
amendment was a sensitive one and a cause of consid erable concern to many Members.  Colombia 
was therefore surprised that the time limit was not ninety days, as recommended in the Fourth 
Triennial Review of the Operation and Implemen tation of the Agreement on Technical Barriers to 
Trade.
8  In this regard, the Colombian representative requested the European Communities to remove 
all nickel classification proposals in the 31st ATP and to explain the EC legislative schedule and the 
steps to be taken prior to the adoption of the 31st ATP, including voting within the Technical Progress 
Committee. 
68. Colombia made this request on the basis of  the European Communities' own assertion in 
notification G/TBT/N/EEC/212 that: "the inclusion of the entries for nickel compounds is still under 
internal review".  This indicated that there wa s uncertainty even within the European Commission 
itself as to whether clear and scientific justificat ion existed for the reclassification of nickel and 
related substances as dangerous substances in the 31st ATP. 
69. The representative of  the Dominican Republic  reiterated concerns on the proposed re-
classification of nickel carbonates and other component s of nickel, which her delegation considered to 
lack sufficient scientific evidence.9  She also noted that the comments expressed by various 
delegations at the meetings of the TBT Committe e on 20 March 2008 had not been taken into account 
for the amendment of Directive 67/548/EEC.  It wa s her delegation's view th at, having been adopted 
in these circumstances, the above-mentioned directiv e did not satisfy the requirements of Article 2.9 
of the TBT Agreement. 
70. The Dominican Republic had serious concerns a bout the timing for adoption of the proposal 
and the basis for the proposed classification of 117 nickel substances.  In particular, the Dominican 
Republic objected to the manner in which the European Communities applied the read-across 
methodology.  While read-across was based on an as sumption that groups of chemicals with certain 
                                                      
7 The full statement detailing Colombia's concerns is contained in document G/TBT/W/297. 
8 See G/TBT/1/Rev.9 p.18. 
9 A communication detailing Dominican Republic's concerns was subsequently circulated in document 
G/TBT/W/302.  G/TBT/M/46 
 Page 15 
 
 
  common characteristics caused similar toxicological  effects, in order to apply the methodology 
properly it was necessary to identify the relevant defining characteristics and then to verify that those 
characteristics in fact produced similar toxicologi cal effects.  Without such verification, the 
assumptions underlying the substance groupings were  scientifically unproven hypotheses.  In this 
regard, the representative of Dominican Republic be lieved that the European Communities violated 
Article 2.2 of the TBT Agreement.  Moreover, she recalled that nickel exports represented, in 2007, 
more than 50 per cent of the total exports of the Dominican Republic, and that the proposed directive 
would have a negative effect on industry and the economy of the country as a whole.   
71. In addition, the representative of the Dominica n Republic was concerned that the legislative 
timetable for the adoption of the 31st ATP failed to provide sufficient time for consultation with other 
WTO Members.  The Dominican Republic believed that , unless rectified, the timetable precluded the 
possibility of a meaningful discussion by the TBT  Committee of the 31st ATP, as it was required by 
Article 2.9 of the TBT Agreement.  In particular, it was noted that the sixty days comment period was 
not sufficient to allow Members to provide comment s, and for the European Communities to review, 
respond and take into account those comments as requi red by Article 2.9.4 of the TBT Agreement.  
Finally, the representative of the Dominican Republic  expressed serious concern about some reports 
that the European Communities could organize a vote of the Technical Progress Committee on 19 November 2008, following which amendments to the 31
st ATP would be virtually impossible.  
Therefore, she reiterated the request that ni ckel substances be removed from the proposed 31st ATP. 
72. The representative of Venezuela  supported the comments made by Ecuador, Cuba, China and 
Canada, and expressed his concern that the adoption of the 31st ATP would create unnecessary 
obstacles to the trade of nickel substances.  In pa rticular, Venezuela was concerned about the lack of 
discussion and evaluation of the 31st ATP among Members; the quality of the technical criteria used 
within the Directive; the read-acr oss methodology; the possibility that a precedent was created.  It was 
also recalled that Venezuela was currently strengt hening its sector of nickel extraction and in 2008 
invested US$100 million in this area.  The re presentative of Venezuela urged the European 
Communities to remove all nickel classification proposals in the 31st ATP. 
73. The representative of Japan  thanked the European Communities for organizing the 
information session on the Dangerous Chemical S ubstances Directive, held on 4 November 2008.  
Japan remained concerned that th e European Communities had proposed  the reclassification of nickel 
compounds under the 31st ATP without giving a satisfactory clarification to the many concerns raised 
on the 30th ATP, in particular with rega rd to the inadequate read-across methodology.  While the read-
across methodology proposed by the OECD required the conduct of an eight steps test for chemical 
categorization, the European Communities did not fully follow the OECD guidance. 
74. The Japanese representative  stressed that the 31st ATP proposal also contained nickel 
hydroxide, and that this substance was widely recognized as a material for manufacturing nickel-
hydrogen batteries, which were commonly known to be  "clean" from an energy perspective.  While at 
the last Committee meeting and at the bilateral m eeting the European Communities had explained that 
the substances covered by this Directive were only required for proper  labelling, Japan was  
concerned that the EC proposal would have a si gnificant impact both on nickel-hydrogen battery 
manufacturers and on their users if nickel hydroxide  would be inappropriately classified on the bases 
of an inadequate read-across. 
75. Furthermore, the European Communities decl ared that the methodology applied for the 
proposed nickel reclassifications would be a model for future classifications under REACH.  In this 
regard, the decision would have a severe impact on the nickel industry and many other related sectors 
as well as their global supply chain, and it would be mo re trade restrictive than necessary.  Therefore, 
the representative of Japan requested th e European Communities to postpone the 31st ATP, especially 
the nickel compounds classification proposal, until Members' concerns were fully addressed. G/TBT/M/46 
Page 16  
 
  76. The representative of Mauritius, speaking on behalf of the ACP group
 shared the comments 
made by previous delegations, in particular those of Cuba and Ecuador.  He  also recalled that on 23 
October 2008 the Chairman of the ACP Commi ttee of Ambassadors in Brussels had sent a 
communication to various European Commission authorities in which serious concerns were 
expressed about the proposed 31st ATP.  The 31st ATP was a matter of concern not only for nickel 
producers but also for those Members that manufactured goods using nickel compounds in other 
industrial chemical processes.  In this rega rd, the read-across methodology used for the 
reclassification of nickel could set a precedent for regulating other substances under REACH thereby 
amplifying the impact of the methodology across numerous products and economic sectors. 
77. It was recalled that Article 2.9.4 of th e TBT Agreement obliged Members to "allow 
reasonable time for Members to make comments in writing, discuss these comments upon request, 
and take these written comments and the results of  these discussion into account".  The European 
Communities was therefore encouraged to exte nd the deadline for submitting comments to the 
notification of the 31st ATP.  His delegation also regretted that , despite the many concerns previously 
expressed by trading partners with regard to the 30th ATP, the European Communities continued to 
use the same methodology for the proposed 31st A T P .   W h i l e  t h e  3 1st ATP relied only on water 
solubility for defining groups of similar nickel  substances, the read-acr oss method was a complex 
process that involved reviewing a number of inputs,  not only a single variable.  Finally, the 
representative of Mauritius stressed that the reclassification of nickel substances without scientific justification would restrict a significant proportion of ACP's trade in nickel substances, and would 
have an adverse impact on the growth and develo pment of ACP countries.  In this regard, the 
proposed 31
st ATP would be inconsistent with Article 12.3 of the TBT Agreement.  The European 
Communities was therefore urged to remove all nickel classification proposals in the 31st ATP so as 
not to create unnecessary obstacles to the trade of nickel substances. 
78. The representative of Brazil  shared the concerns raised by other Members and supported, in 
particular, the comments made by Ecuador on beha lf of GRULAC.  He expressed his delegation's 
concern that the 31st ATP, like the 30th ATP, appeared to be based on a conjunction of wrong 
assumptions and weak science.  It was noted that the proposed 31st ATP classified as hazardous more 
than one hundred nickel components, treating them  as proven human carcinoge ns and many of them 
as reproductive toxigens and mutagens. 
79. The representative of Brazil stressed that the 31st ATP would impose unjustifiable restrictions 
on international trade, especially for developing countries.  In particular, Brazil was seriously 
concerned that the classification of nickel compounds in the 31st ATP had been done by means of an 
inadequate use of read across methodology.  In f act, water solubility was used as the only criteria to 
group nickel compounds for which no data existed, and to assign them toxicological properties of 
some reference substances.  It was recalled that su ch an approach was contrary to the OECD guidance 
on read-across, which stated that category assessme nts were often complex and involved reviewing a 
number of inputs.   
80. Brazil therefore requested the European Commun ities to explain why some fundamental steps 
indicated in OECD guidance had been skipped in th e process of reclassification of nickel compounds.  
The representative of Brazil also noted that, while nickel carbonates served as a reference substance 
of soluble nickel compounds in the 31st ATP, however, the classification of nickel carbonates as 
hazardous substances in the 30th ATP was also carried out amid a lack of toxicological data and 
inappropriate use of read-across.  Specifically, the classification of nickel carbonates was based on 
nickel sulphate which had different properties rega rding water solubility.  In this regard, Brazil 
encouraged the European Comm unities to explain why water solubility was disregarded when 
classifying nickel carbonates in the 30th ATP, and, instead, chosen as the only criteria for grouping 
nickel compounds in the 31st ATP.  G/TBT/M/46 
 Page 17 
 
 
  81. It was also noted that, in the notification of the 31st ATP, the European Communities 
mentioned that the inclusion of nickel compounds was still under internal review and if the draft 
directive was modified in this respect, a revised dr aft directive and revise explanatory note would be 
submitted, if possible within the 60 days commenting period.  Given the complexity of this issue, Brazil requested the European Communities to grant another 60 days comment period if the draft 
Directive would be modified.  In this regard, Brazil joined other delegations in asking for an extension 
of the period for comments on the 31
st ATP.  Finally, the Brazilian delegation encouraged the 
European Communities to clarify why the 31st ATP had to be adopted by the end of the year if, as 
stated, the Globally Harmonised System of classi fication and labelling of chemicals (GHS) would 
revoke the Directive the following year. 
82. The representative of Indonesia  shared the comments made by previous delegations about the 
proposed 31st ATP.  In particular, Indonesia requested th e European Communities to ensure that the 
Dangerous Substance Directive 67/548/EEC would not  create unnecessary obstacles to trade, as set 
out in Articles 2.2 and 12.3 of the TBT Agreement. 
83. The representative of Philippines  joined the concerns raised by other Members on the 
reclassification of nickel, and stressed that this Directive could unnecessarily restrict international 
trade in nickel products. 
84. The representative of Australia  reiterated her concerns regarding the EC's reclassification of 
nickel carbonate under the 30th ATP and with the EC proposed reclassification of more than 117 other 
nickel compounds under the draft 31st ATP.  Australian 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 carcinogenic poten tial of nickel carbonates, that the use of read-
across methodology should be based on groupings of substances which were robust and scientifically 
valid and that solubility in water alone was an insufficient criterion on which to base read-across 
methodologies.  These conclusions had been pr esented to the European Communities on 29 
September 2008. 
85. While Australia appreciated the opportunity to address the experts' meeting organized by the 
European Communities, concerns re mained that the conclusions reach ed had been disregarded.  In 
particular, the representative of Australia remained  concerned that the EC approach to the nickel 
group could create a precedent for the manner in which other groups of chemical substances would be 
classified in future, including under the 31st ATP and REACH.  In particular, it was her delegation's 
understanding that Annex VI of the Proposal for a Regulation of the European Parliament and of the 
Council on Classification, Labelling and Packagi ng 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 30th and 31st ATP, and those coming from REACH, 
via an ATP procedure.  This would create a prec edent, and her delegation was concerned about the 
scientific and procedural grounds of this precedent. 
86. The representative of Australia stressed that the EC proposed reclassification of nickel 
substances under the 31st ATP would have a significant econom ic and commercial impact on all 
nickel producing and exporting countries, including developing countries.  She also highlighted that the nickel compounds listed in ATP 31
st were used in a large range of processes.  In this context, 
concerns remained that nickel substances and prep arations containing such substances would need to 
be labelled with danger symbols, including the "skull and crossbones", which would potentially 
contribute to the stigmatisation of nickel and nickel -containing material and could reduce research and 
investment in important nickel-based technologies a nd materials; that the reclassification of nickel 
compounds as Category 1 and 2 carcinogenic and mu tagenic compounds would trigger a series of 
downstream regulatory requirements which would im pose addition restrictions and prohibition on the 
substances; that the reclassified Category 1 or  2 carcinogenic and mutagenic substances would be G/TBT/M/46 
Page 18  
 
  deemed "substances of very high concern" (S VHC) under REACH and could result in additional 
restriction, prohibition, or substitution of nickel; and finally that the planned classification would 
reduce supply of nickel substances to downstr eam users and damage the competitiveness of 
manufactures in critical sectors th at rely on nickel substances. 
87. Furthermore, Australia recalled that, in accordan ce with Article 2.2 of the TBT Agreement, 
technical regulations should not be more trade restrictive than necessary to fulfil a legitimate 
objective.  The European Commun ities was therefore requ ested to assess what the trade impacts 
would be prior to the adoption of the 31
st ATP, particularly given the serious concerns expressed by 
developed and developing countries.  Australia also supported the concerns raised by the ACP group 
that the reclassification of nickel compounds without scientific justification would restrict a 
significant proportion of the ACP trade in nickel substances, and would have negative impacts on 
their growth and development.  Given the signi ficant commercial implications of the proposed 
reclassification of nickel compounds under the 31st ATP, it was essential that any restriction imposed 
by the European Communities on nickel compounds be based on sound and transparent science which 
did not place unnecessary obstacles to international trade. 
88. The representative of Australia was further c oncerned by reports that, on 19 November 2008, 
the EC Technical Progress Committee would vote on the 31st ATP.  In this regard, she asked the 
European Communities to confirm the date of this me eting and explain how they  planned to take into 
account the comments submitted by trading partners in accordance with Article 2.9.4 of the TBT Agreement.  She sought assurance that no action would be taken to implement the 31
st ATP until the 
concerns raised by nickel producing and e xporting countries were satisfactorily addressed. 
89. In concluding, the representative of Australia encouraged the European Communities to adopt 
a sound, defensible and transparent science-based  approach to the reclassification of nickel 
compounds, and to refrain from the implementation of the 31st ATP until the concerns expressed by a 
wide range of affected stakeholder, including members of the TBT Committee, were satisfactorily discussed.  Australia recognised the importance of ensuring a high standard of protection for human 
health and environment, and supp orted the development of regulatory strategies to achieve such 
protection.  However, in accordance with Article 2.2 of the TBT Agreement, these regulations should 
not create unnecessary obstacles to international trade.   In this context, Australia also noted that 
Article 2.9.4 of the TBT Agreement stated that if a technical regulation could have a significant effect 
on trade of other Members, the introducing Member  should "allow reasonable time for other Members 
to make comments in writing, discuss these comments upon request, and take these written comments 
and the results of these discussions into account". 
90. The representative of Korea
 supported the objectives of protecting health and the 
environment.  However, taking into account th e significant impact of the Dangerous Chemical 
Substances Directive on industry, Korea encourag ed the European Communities to implement the 
ATP 31st only after careful consideration of scientif ic evidence, social and economic impact 
assessments and further technical consultations with WTO Members. 
91. The representative of Botswana  joined the statement made by Mauritius on behalf of the ACP 
group, and raised further concerns about the 31st ATP.  It was stressed that Botswana was a small and 
vulnerable economy, highly depende nt on mineral exports, including diamonds, copper, nickel and 
soda ash.  In 2007, nickel contributed to about fifty per cent of all exports.  The representative of 
Botswana also noted that copper and nickel  mining sectors had benefited from the SYSMIN 
programme, a system created by the European Co mmunities to stabilize export earnings from mineral 
products.  However, this system would be  undermined by the proposed directive. 
92. The representative of Botswana was concerned th at the reclassification of nickel compounds 
as dangerous substances would have far reaching implications for the mining industry in his country,  G/TBT/M/46 
 Page 19 
 
 
  as well as potentially harming other sectors of the economy.  It was recalled that this would negatively 
affect the trade, economic growth and developmen t of Botswana, particularly at a time of global 
financial crisis.  In particular, concerns remain ed about the adoption of the water solubility read-
across method in the 31st ATP, which Botswana did not believe to be an appropriate indication of 
toxicity.  Botswana recognised the importance of ensuring a high standard of protection for human 
health and environment and supported the devel opment of regulatory strategies to achieve such 
protection.  However, in accordance with WTO pr ovisions, it was recalled that these regulations 
needed to take into account the special developmen t, financial and trade needs of developing country 
Members.  The European Communitie s was therefore encouraged to re move all nickel classification 
proposals in the 31st ATP and provide technical assistance to developing countries with regard to 
REACH. 
93. The representative of Zimbabwe  supported the statement made by Mauritius on behalf of the 
ACP group, Cuba and other delegations.  She reca lled that the proposed reclassification of nickel 
compounds under the 31st ATP did not take into account the speci al development, financial and trade 
needs of developing country Members.  Finally, the European Communities was urged to extend the 
comment period of the draft directive. 
94. The representative of South Africa  echoed the concerns already expressed about the adoption 
of the 31st ATP by various delegations, particularly tho se of Canada and Cuba.  While his delegation 
supported the protection of human health and envi ronment, the proposal appeared to go far beyond 
the previously established process for identifying hazardous properties based on scientific data.  
Furthermore, the 30th and the 31st ATP relied on a questionable read-across methodology, which did 
not follow the eight steps for read-across describ ed in the OECD guidance documents.  Also, South 
Africa remained concerned about the timing for adop tion of the proposal and the scientific basis for 
the nickel reclassifications.  In particular, th e South African representative noted that the 31st ATP 
read across the most severe classifications from f our identified substances with scientifically proven 
hazardous properties to almost all market ed nickel-containing substances.    
95. South Africa was especially concerned that these classifications would not only be applied in 
Europe but that, through the mechanism of the UN 's Globally Harmonised System of classification 
and labelling of chemicals (GHS), they would be extended world wide.  Furthermore, South Africa 
was deeply concerned that these substances would be deemed "substances of very high concern" 
(SVHC) under REACH, resulting in additional restri ction, prohibition, or substitution of nickel 
substances.  It was his delegati on's understanding that many of th ese substances would meet the 
criteria for listing in Annex XIV of REACH because of the tonnages used by industry.  In that case, a 
company would not be allowed to place on the market  or use a substance included in Annex XIV of 
REACH unless the European Commission would grant a use specific and time limited authorisation.  The progressive replacement of these materials woul d in effect prevent th e use and production of 
nickel metal and eliminate nickel substances fro m use in many thousands of important chemicals 
applications from batteries, catalysts, electronic components, through to dyes and inks.   
96. In concluding, the representative of South Afri ca stressed that this would effectively shut 
down an important industry for South Africa and other developing countries.  It was recalled that the 
EC market accounted for about forty per cent of to tal world nickel usage, and that South Africa's 
share of this market was worth some US$4 billio n per annum.  South Africa believed that the 
implementation of the 31
st ATP would seriously affect the future investment by the industry itself and 
impact negatively on trade and growth.  Theref ore, the representative of  South Africa urged the 
European Communities to remove all ni ckel classification proposals in the 31st ATP and extend the 
comment period on the notification of the Directive. 
97. The representative of Turkey  joined the concerns expressed by other Members on the 
proposed reclassification of nickel compounds under the Directive 67/548/EEC.  With regard to the G/TBT/M/46 
Page 20  
 
  30
th ATP, the inclusion of a preamble indicating the possibility of re-evaluating the classification of 
certain substances in the light of new scientific  information was not considered to address the 
scientific shortcomings of the adopted classificatio n.  In particular, it was recalled that Members 
appeared to be unable to agree on a common meaning of  the term “scientific”.  In this context, the 
representative of Turkey regretted that th e European Communities had adopted the 30th ATP without 
taking into adequate consideration the comments made by other WTO Members. 
98. The Turkish representative pointed ou t that the objections to the 30th ATP were also valid for 
the 31st ATP.  Finally, the delegation of Turkey reiterated that the classification decisions in both the 
30th and 31st ATP did not have a legitimate objective and had the effect of creating unnecessary 
obstacles to trade.  The EC’s approach to classifyin g substances also appeared to set an inappropriate 
and dangerous precedent for other assessments.  Theref ore, these classifications were considered as 
infringements of Turkey’s rights under the relevant  provisions of the TBT and GATT Agreements.   
99. The representative of India  shared the concerns raised by previous speakers about the 
proposed reclassification of nickel compounds.  Indi an industry had a significant export interest in 
industrial products containing nickel compounds.  The European Communities was therefore 
encouraged to resolve this issue on the basis of sound scientific analysis, in order not to cause any 
unnecessary barrier to trade. 
100. The representative of Chile  associated himself with the comments made by the delegation of 
Ecuador on behalf of GRULAC.  While he tha nked the European Communities for organizing the 
information session on the Dangerous Chemical Subs tances Directive (4 November 2008), he shared 
the concerns already expressed by other WTO Member s.  In particular, he encouraged the European 
Communities to extend the deadline for submitting comments to the notification of the 31st ATP. 
101. The representative of the United States  reiterated his de legation's concern regarding both the 
30th and 31st ATP.  With regard to the 30th ATP,  he regretted that the European Communities had 
finalized the 30th ATP and, as a result, classified bora tes as a Category 2 substance.  In particular, he 
noted that the European Communities did not appear  to have taken into account the normal handling 
and use of borates-containing products when prop osing its classification of borates, and that the 
European Communities acknowledged that its classi fication was entirely hazard-based and did not 
factor in the actual risks of exposure from intended e nd uses.  Additionally, the representative of the 
United States reiterated his dele gation's concerns regarding the "skull-and-crossbones" labelling 
requirements for certain borates-containing produ cts; the "knock-on" effects under other EC 
legislation, including a ban on the use of borates in  cosmetics, restrictions under the Marketing and 
Use Directive, and potential placement on the REAC H authorization candidate list of a Category 2 
classification; and the potential adverse impacts that this could have on the sale and trade of borates and borate-containing products. 
102. With regard to the EC intention to conduct risk and impact assessments before subjecting 
borates-containing products to restrictions under the Marketing and Use Directive, he noted that the 
United States was closely monitoring the process  and encouraged the European Communities to 
clarify the status of those assessments.  Were such assessments being c onducted for all downstream 
products containing borates?  When could United States expect that those assessments would be 
completed?  Would any products be subjected to restriction under the Marketing and Use Directive 
before the finalization of the assessments? 
103. With regard to the 31
st ATP, it was noted that the US nickel plating industry had recently 
submitted information indicating its concerns with  the proposed Category 1 classification of nickel 
compounds and its serious impact on trade of nick el-containing products in several key industry 
sectors.  In particular, industry had noted that a pproximately 1,000 compani es in the United States 
provided electrochemical coating services using nickel compounds for thousands of parts and  G/TBT/M/46 
 Page 21 
 
 
  components in the automotive, aerospace, electroni cs, industrial machinery, hardware and other 
sectors.  The market value of US nickel electropl ating and related finishing services was estimated to 
be US$3.5 billion annually.  Given the potential impa ct of Category 1 classification, representative of 
the United States urged the European Communities to  undertake a science and risk-based analysis, in 
which the available scientific and technical inform ation and intended end uses of individual nickel 
compounds would be evaluated.  
104. In this context, the representative of the Un ited States was understanda ble concerned with the 
EC argument in the case of borates that a hazard analysis was enough to classify a substance under Category 2  of the Dangerous Substances Directiv e.  If the European Communities would take the 
same approach to analyzing the classification of nickel compounds in the 31
st ATP, the United States 
would have similar concerns.  In addition, the US re presentative also noted that in its analysis of the 
nickel compounds proposed to be classified under Category 1 in the 31st ATP, the Danish Competent 
Authority appeared to skip certain steps when applying the OECD read-across methodology.  These 
steps involved evaluating available scientific and technical information and intended end uses of the 
relevant nickel compounds, raising questions as to  whether the European Comunities adequately took 
those into account in its analysis.  Therefore, the United States urged the European Communities to 
delay the classification of nickel compounds unde r Category 1 of the  Dangerous Substances 
Directive until these issues were resolved.  The United States w as also monitoring the potential 
adverse trade impacts of the classificat ion of borates under Category 2 in the 30th ATP, and would 
continue to analyze the European Communities' classification methodology that had led to these 
classifications in the context of REACH and other EC measures. 
105. In concluding, the representative of the United States drew the Committee's attention to the 
ongoing work in ISO on the development of a stan dard on Social Responsibility, ISO 26000, which 
included provisions on chemicals and hazardous substances.  It was his delegation's opinion that the 
draft standard could be invoked by Members as a putative legal defence for chemicals-related 
measures that inhibited trade and that were not ri sk based, thereby circumventing efforts in the TBT 
Committee to review these measures.  In this re gard, all Members were urged to discuss the EC 
chemicals measures with their IS O representatives, in order to ensure that they understood the 
potential trade policy consequences of the draft ISO standard. 
106. The representative of the Russian Fe deration, speaking as an observer , shared the concerns of 
previous delegations with regard to the nickel cl assification and stressed that the proposed measure 
would negatively affect international trade, cr eating unnecessary obstacles to trade while not resulting 
in practical benefit for health and the environment.   In this context, attention was drawn to the 
European Communities improper implementation of the read-across methodology prescribed by the 
OECD guidelines.  Furthermore, while the Russian Federation appreciated the information session on the Dangerous Chemical Substances Directive orga nized by the European Communities, concerns 
remained on several issues.  The representative of the Russian Federation therefore urged the 
European Communities to remove all nickel classification proposals in the 31
st ATP until WTO 
Members' concerns were fully addressed. 
107. The representative of the European Communities  regretted that at the information session on 
the Dangerous Chemical Substances Directive, held  on 4 November 2008, only six of the twenty-two 
delegations that intervened on the notification of the 31st ATP took the floor to share their views and 
concerns with EC experts.  However, the Europ ean Communities believed that the meeting had been 
useful to clarify some of the concerns and questions that were raised, as well as to explain in more 
detail how the grouping approach and read-across methodology were applied.  In respect of methodology, the representative of the European  Communities informed the Committee that the 
methodology used in the classification of the 31
st ATP was similar to the one used for the 30th ATP, 
and therefore many of the questions raised on the 31st ATP had already been clarified during the 
discussions on the 30th ATP proposal.  Although the 31st ATP draft was notified to the TBT G/TBT/M/46 
Page 22  
 
  Committee in September 2008, she noted that the pr oposal had been available together with all 
relevant documents from the expert meetings si nce December 2007, and di scussions with nickel 
industry and stakeholders had been ongoing si nce 2005.  Therefore, the European Communities 
believed that sufficient time had been grante d to Members to examine and comment the 
aforementioned proposal. 
108. The representative of the European Communities gave a short description of the proposed 
measure.  She recalled that the Dangerous Subs tance Directive 67/548/EEC had been regularly 
amended, the latest one being the 30
th ATP (adopted in August 2008).  She also recalled the objective 
and extent of the EC proposal: the substances covered by this proposal (over 6 00) would need to bear 
a label which aimed at informing those who handle d these substances, that they should be handled 
with care.  It was her delegation's understanding th at this was the least trade-restrictive measure 
available to convey such information to the people in  contact with the substances at issue, therefore in 
line with Article 2.2 of the TBT Agreement.  Th e EC representative recalled that the label would 
provide information on the hazardous properties of th e preparations, but this classification would not 
ban or restrict the use of these subs tances on consumer end-products.   
109. In this context, the EC representative drew th e Committee's attention to the fact that the 
European Commission was required to examine within six months of the adoption of the classification 
proposal whether the use of those substances or prepar ations in final consumer products needed to be 
restricted, for example by setting a maximum concen tration level for a given substance.  It was 
stressed that a risk assessment would need to be carried out before imposing any type of marketing 
restrictions, or setting maximum exposure levels or bans.  In addition, the representative of the 
European Communities pointed out that, due to ni ckel's allergen properties, only few consumer 
products still contained mixtures of nickel compoun ds.  Therefore, she rebutted the comments which 
suggested that the proposed classification would have a significant impact on the exports of nickel compounds to the European Communities.  She furthe r recalled that no substantive information about 
the economic impact this classification could have  under REACH or other EC legislation had been 
received to date.   
110. With regard to the requests of postponing the implementation of the 31
st ATP, the EC 
representative noted that the vote of EC member  States at the Technical Progress Committee (TPC) 
would take place only after the expiration of the comment period.  Moreover, while her delegation 
regularly met the representatives from nickel industr y and expert from third countries, to date the 
European Communities had not received any scientific  information which could contradict the EC 
assessment.  She informed the delegation of the Unite d States that the impact assessment on the use of 
borates in cosmetic products was being finalized, and was expected to become available at the end of 
2008.  She also pointed out that the use of borates in cosmetic products was already restricted and therefore the 30
th ATP had not modified the situation. 
111. An expert from the DG Environment of the Eu ropean Communities info rmed the Committee 
that the Globally Harmonised System of classifi cation and labelling of chemicals (GHS) would be 
implemented by the European Communities.  In respon se to some of the questions raised, he said that 
the grouping approach had been used in the frame work of the Dangerous Substance Directive for 
years.  Three specific examples (lead and lead compounds, chromates, petroleum streams and gases) 
were used to explain that this approach was not  new.  Moreover, the harmonized classification and 
labelling of nickel compounds was not new either:  ten nickel compounds were  contained into Annex 
1 of the Dangerous Substance Directive and had a harmonized classification and labelling since 15 
years. 
112.  On the issue of complian ce with the OECD guideline on grouping approach, the EC 
representative pointed out that the same comments had already been clarified in the context of the 30th 
ATP at the Committee Meeting held on 20 March 2 008.  He reiterated that the OECD guideline on  G/TBT/M/46 
 Page 23 
 
 
  groupings had not been applied, in particular the la st two steps (confirmatory testing) so as to avoid 
unnecessary animal testing.  Instead, when such conf irmatory testing was required to confirm that a 
classification was necessary, the European Communities had chosen the approach of not classifying at all. 
113. On the comments that the EC approach to nick el compounds could create a precedent for the 
manner in which other groups of chemical subs tances would be classified in future, the EC 
representative recalled that identical rules applie d for industry.  In other words, the grouping 
approaches chosen would also be used by industry for meeting the registration requirements of their 
substances under REACH.  Therefore, if a gr ouping approach needed a significant amount of 
information to be applied within a regulat ory context for setting labelling and harmonized 
classification, the same amount of information would be required for the registration dossiers 
submitted by industry under REACH. 
114. On the question regarding the rationality of the phasing between the 30
th ATP, the 31st ATP 
and the GHS, the representative of the European Co mmunities pointed out that the reasons for a two-
step procedure with the ATP and the GHS was that the working procedures were different.  In fact, 
under the GHS the European Agency  on Chemicals (ECHA) had a central role, where under the ATP 
the same role was vested in the European Chemicals Bureau as part of the European Commission.   
115. The main assumption of the approach that had been followed to classify nickel compounds in 
the 30th and 31st ATP was that a nickel ion was responsible for the toxicological ef fect of the nickel 
compounds.  The approach used in this case, based on water solubility and other information (e.g., 
chemical structure of the compounds), appeared to be  a widely recognised approach and was not new.  
For nickel compounds, this approach had been valida ted by EC experts, independent scientific experts 
within the European Union and experts from OECD c ountries.  It was stressed that the same approach 
was also used by some WTO Members to classify  insoluble compounds as carcinogen, like Australia.  
Additionally, the International Agency for Resea rch on Cancer (IARC) also classified nickel 
compounds as carcinogenic.  It was stressed that th e European Communities had information, based 
on expert judgement, that both soluble and insol uble nickel compounds were carcinogen and should 
be classified as carcinogen Category 1.  Also, based  on information available (human and animal 
data), soluble nickel compounds had been classified as toxic for reproduction.  
116. The representative of Cuba  remained concerned that no scientific publications had been cited 
by the European Communities.  He regretted th at, despite the significant number of WTO Members 
that had asked to extend the period for comments on the notified 31st ATP, the European 
Communities had decided not to reconsider the deadlin e.  With regard to the scientific information 
which could contradict the EC assessment, the Cuba n representative stressed that according to Article 
2.2 of the TBT Agreement the burden was not on foreign companies to provide information, but rather on the European Communities to make sure th e regulation was clear and not discriminatory.   
117. Furthermore, the representative of Cuba recalle d that the EC directive lacked scientific 
consistency and did not allow enough time for Member s to submit comments and for consultations to 
be held.  Nor was this period sufficient for the Eu ropean Communities to review and take into account 
these comments, as required under the TBT Agreement.  Cuba also sought clarification on the date of 
the Technical Progress Committee, in which EC memb er States would be asked to vote on the 31
st 
ATP.  With regard to the EC comment that the 31st ATP proposal had been discussed with nickel 
industry and stakeholders since 2005, the representa tive of Cuba drew the Committee's attention to 
the fact that at the last TBT Committee meeting the European Communities re presentative stated that G/TBT/M/46 
Page 24  
 
  the list of substances to be classified in the 31
st ATP had not been drafted.10  Therefore, he asked the 
European Communities how comments could be made  when there was no classification of products. 
118. The representative of Australia  reiterated that her delegation did not oppose the use of read-
across methodology when it was correctly applied in a transparent and scientifically valid manner.  In 
response to the EC comments that no substantive information about the economic impact of this 
classification had been received, the representative of Australia remarked that her delegation had 
provided the European Communities with relevant in formation.  However, she stressed that it was 
difficult to provide concrete examples  of trade impacts of a directive th at was yet to enter into force.  
Furthermore, since the EC proposed re-classifica tion of nickel substances would have a significant 
economic and commercial impact on developed and deve loping countries, the Australian delegation 
requested the European Communities to clarify wh at assessment of the trade impact of the 31st ATP 
had been done.  Finally, Australia requested clar ification on the date of the Technical Progress 
Committee (TPC) and urged the European Comm unities to extend the comment period on the 
notification of the directive. 
119. The representative of the Dominican Republic  reiterated her delegation's position that the 
proposed re-classification of nickel compounds lacked  sufficient scientific basis.  In particular, 
concerns remained that the European Communities di d not provide the scientific data and publications 
used to formulate its "expert judgement".  Also, the representative of the Dominican Republic stressed 
that the legislative timetable for the adoption of the 31st ATP failed to provide sufficient time for 
consultation with other WTO Members.  She reiterate d the request that nickel substances be removed 
from the proposed 31st ATP. 
120. The representative of United States  thanked the European Communities for the responses but 
noted that numerous concerns remained with the proposed re-classification of nickel compounds. 
121. The representative of the European Communities  assured Members that all comments 
received before the deadline would be responded to  before the classification of nickel compounds 
became law.  He stresse d that his example about lead was intended to show that even though a 
classification had been made because of the danger po sed by this substance, there had not been any 
major trade dispute, or disruptions to trade – at least  not that had been brought  to the attention of the 
European Communities.  On another point he emph asized that there was no direct consequences in 
terms of a ban from a Category 1 or 2 classification – except in the area of cosmetics. (However, it was pointed out that it was unlikely that as nickel  compounds would be used in cosmetics as they 
were know allergens).  Nevertheless, there was i ndeed an obligation on the Commission to evaluate 
whether a ban was necessary for consumer uses of Category 1 and 2 substances.  This was the case of 
borates where an assessment was unde rway.  The representative of th e European Communities further 
clarified that in respect of consequences for o ccupational health and safety (from classification as a 
Category 1 or 2 carcinogen), these would be limited to w ithin the European Union.   He reiterated that 
the European Communities did not expect, from the cl assification exercise, major trade implications – 
if countries did believe that there would be such  effects, they were welcome to provide this 
information to the European Communities so that it could be assessed, and appropriate action be taken.     
122. The representative of Canada
 reiterated that the European Communities did not provide 
enough time for consultation with WTO Members regarding the 31st ATP and requested clarification 
on the date of the Technical Progress Committee. 
123. The representative of the European Communities  urged delegations that still had concerns to 
make comments in writing.  On the date of the Technical Progress Committee, he explained that the 
                                                      
10 See G/TBT/M/45, par. 106.  G/TBT/M/46 
 Page 25 
 
 
  EC member States would vote on the 31st ATP proposal only after careful consideration of the 
information provided by WTO Members.  In  this regard, he emphasized that the 30th ATP had been 
discussed in four TBT Committee meeting; howeve r, in those meetings no arguments or new 
information had been presented.  The EC represen tative recalled that any new information would be 
examined and taken into account, but the adoption of the 31st ATP proposal would not be delayed 
only on the basis of speculation.   
124. The representative of Cuba  noted that various concerns remained and said that his delegation 
would present its written comments to the European Co mmunities in order to further discuss the issue.  
In response to the EC comments, it he noted th at the Cuban industry had provided significant and 
detailed information on the proposed re-classification,  but this had not been taken into account by the 
European Communities. 
125. The representative of Australia  thanked the European Communities for the responses but 
noted that numerous concerns remained with the proposed 31st ATP. 
126. The representative of Brazil  thanked the European Comm unities for the responses, but 
stressed that various concerns remained and more time should be allowed to discuss this issue.   
127. The representative of the European Communities  stated that the studies used for the EC 
assessment and the minutes of the expert meetings would be provided to interested delegations.  
Finally, with regard to the comment of Cuba that  studies provided by industry had not been examined, 
he explained that they had been discussed in a meetin g with the nickel industry.   However, the experts 
recognised that these studies were interesting, but e ither incomplete or inconc lusive; therefore, they 
did not indicate that the proposed EC classifi cation for those substances was inappropriate. 
(xii) European Communities - Capacity labe lling of batteries and accumulators 
128. The representative of Japan  noted that the EC Directive on batteries would mandate the 
labelling of battery capacities as of 26 September 2009, but the methods for measuring these capacities had not yet been announced.  Battery manufacturing companies within the European 
Communities would be able to comply with the Di rective within the six month preparation period, 
since they were only required to ship the compliant  batteries before the deadline.  However, in the 
case of electrical and electronic equipment where batt eries were enclosed with the products, or lead 
storage batteries embedded in automobiles, a certain amount of time would be required to measure the 
capacities of the individual ba tteries, for the design and manufacture of the labels, and for 
transportation and clearance of dist ributor inventory.  This meant that it was impossible for companies 
outside the European Communities to comply within the preparatory period of six months.  
129. The short preparatory period in these regulations  was unfair on companies outside the region, 
and was not in line with the principle of nati onal treatment embodied  in Article 2.1 of TBT 
agreement.  He believed that the preparatory pe riod should be of at least one year between the 
announcement of the measuring methods and the time the Directive came into effect. 
130. The representative of the European Communities
 explained that the European Commission 
was currently preparing requirements for capacity labelling of all portable and automotive batteries 
and accumulators in accordance with Article 21 of th e Directive on batteries.  Such capacity labelling 
requirements did not exist yet at Community level.  She pointed out that a study on the measurement 
method for batteries capacity label had been finaliz ed and that it would constitute the basis for the 
Commission and EC member States to develop rules for the implementation of these requirements.  She noted that member States would be responsible for ensuring that the capacity of all portable and 
automotive batteries and accumulators was indicated  on them by 12 September 2009 and that the 
same requirements would be applied to manufactur ing companies within and outside the European G/TBT/M/46 
Page 26  
 
  Communities, without discrimination.  Industry w ould be given enough time to prepare for these new 
requirements and the measures would be notif ied to the TBT Committee as appropriate. 
2. Previously raised concerns 
(i) China – Compulsory Product Certification (CCC) (G/TBT/N/CHN/399 and Suppl.1) 
131. The representative of the European Communities
 welcomed the notification made by China 
on 24 June 2008, on which his delegation had ma de detailed comments, concerning a draft 
amendment to the regulations on compulsory product certification, and hoped that this was a first step 
in a process involving a more substantive review  of the Chinese Compulsory Product Certification 
System (the "CCC system").  He sought assuran ce from the Chinese authorities that interested 
stakeholders would be closely involved in th e implementation of the detailed product category 
specific rules that would have to be enacted by the Certification and Accreditation Administration of 
the People's Republic of China (CNCA) following the adoption of the framework regulation.  He also 
sought clarification regarding the timeline for the entry into force of the regulation.  His delegation, as noted on previous occasions, believed that the current  version of the CCC system was one of the main 
obstacles companies faced in their trade with China due to the complexity, time consuming nature and 
cost of the procedure.  For SMEs in particular, the burden was heavy and in some instances simply 
impossible to cope with.   
132. The representative of the European Communities encouraged China to undertake a structural 
review of the CCC system as part of the impl ementation of the revised framework regulation. 
Specifically, his delegation believed that China needed  to systematically apply a risk-based approach 
to conformity assessment, with a view to reducing the number of products within the scope of the 
CCC.  Conformity assessment requirements, in particul ar those relating to factory inspections, testing 
and certification needed be modulated according to the level of risk associated with the products to be 
regulated.  He stressed that th e European Communities stood ready to  assist in the process by sharing 
experiences with CNCA experts on the management  of conformity assessment systems for various 
products based on the suppliers decl aration of conformity (SDoC) and effective market surveillance. 
133. Additionally, the representative of the Eur opean Communities invited China to consider 
providing opportunities for mutual r ecognition of testing results based on international standards.  He 
also stressed that confidentiality obligations of t esting and certification organizations needed be set 
out with respect to any commercially sensitiv e information obtained during the testing and 
certification process.  He underlined the importance of  publishing and enforcing clear rules to ensure 
that test laboratories and certification bodies operated in such a way that conflicts of interest were 
prevented.  Clearly defined conditions under which such organizations could engage in additional 
business activities were also important.  
134. The representative of the European  Communities further stressed th at a clear reference to the 
risks associated with the products was needed.  His delegation hoped that China could provide that 
foreign-owned testing and certification organizations  legally established in China were eligible for 
designation by CNCA to perform the testing and certification activities required under the framework 
regulation on equal terms to Chinese-owned c onformity assessment bodies.  He believed that 
inspection requirements in the regulation needed to  be simplified, and sought assurance that when 
applicant companies held certificates of their qualit y management systems, factory inspections would 
be limited to verifying only those additional require ments laid down in the CCC regulation that were 
not already covered by the said certificates.  His de legation hoped for wider exemptions with respect 
to spare parts and components, in order to elim inate the current duplicative certification obligation 
that concerned spare parts and components which were used for assembling final products, which 
were themselves subject to CCC certification.    G/TBT/M/46 
 Page 27 
 
 
  135. The representative of China  noted that a detailed reply to the comments and questions raised 
by the European Communities had been prepared, including on the implementation timetable, on how 
to deal with the protection of confidential info rmation, on how to ensure the involvement of 
certification bodies, on spare parts and components and on exceptions from CCC certification.  He 
pointed out that the objective of the modifica tion of the CCC system was to streamline the 
compulsory certification design and to improve the effectiveness of the system, based on the 
experience accumulated in the past six years.  With  respect to the recognition of foreign certification 
bodies and their testing results, he stressed that Ch ina recognized the test results of the IECEE CB 
scheme, in accordance with the re gulation of the People's Republic of China on certification and 
accreditation.  Foreign certification bodies qualif ied for CCC certification could only be allowed 
through inter-government agreement, agreemen ts recognized by the Chinese government or 
agreements with competent authorities of the Ch inese government.  So far, China had signed 15 
cooperative agreements with agencies or certific ation bodies from other countries and regions which 
covered, for example, factory inspection and recognition of certification testing results.  
136. On the issue of SDoC, in accordance with th e TBT Committee's discussion in the Second, 
Third and Fourth Triennial Review of the TBT Ag reement, the representative of China pointed out 
that there was a common view that, in order to ensure that SDoC was implemented effectively, 
appropriate legislative framework including safegua rds against non-compliance of dangerous products 
such as market surveillance and product liability legisla tion needed to be established in advance.  As a 
developing country Member, China had difficulties in this regard, therefore SDoC had not yet been 
adopted as part of conformity assessment procedur es.  His delegation looked forward to continued 
cooperation and sharing of experiences with th e European Communities and other interested 
Members.   
(ii) China – Excessive packaging (G/TBT/N/CHN/447 and Suppl.1) 
137. The representative of the European Communities  noted that the recently notified draft aimed 
at restricting excessive packaging of certain commod ities and that its content was similar to the one 
notified previously (G/TBT/CHN/N/321) and on which the European Communities had expressed 
concerns in the TBT Committee of March 2008, wh ile stressing that it supported the objective of 
restricting excessive packaging in order to protect the environment.  As a reply to the EC concerns, 
China had confirmed that the provision laying down that for certain products the total cost of 
packaging should not exceed 15 per cent of the sales price was a recommendatory provision.  
However, it appeared that in the new notified draft the cost requirement had become a mandatory requirement and the representative of the European Communities sought clarification as to why 
China had changed the approach previously announced.  
138. The representative of the European Communities al so reiterated concerns with regard to such 
a cost requirement.  Her delegation was of the opinion  that the fact that packaging was costly did not 
always and automatically mean that it had the most harmful impact on the environment.  Moreover, it 
would be difficult to respect and to verify this re quirement, since the compliance could not be verified 
with regard to the product itself, but needed the collection, submission and verification of 
considerable amount of data in or der to calculate the packaging co st, the sales price and the relation 
between both. This data would be especially  difficult to provide for imported products.  
139. As a consequence, rendering this provision mandatory was considered as more trade 
restrictive than necessary to fu lfil the pursued legitimate objective of the protection of the 
environment and therefore not in compliance with Ar ticle 2.2. of the TBT Agreement.  In addition, 
even if the provision applied equally to domes tic and imported products, it was more difficult to 
comply with for importers, which was contrary to Article 2.1. of the TBT Agreement.   China was 
invited to reconsider its approach that rendered th is requirement mandatory.  These concerns had also G/TBT/M/46 
Page 28  
 
  been expressed (along with the request for furthe r clarifications), in the comments sent by the 
European Communities to China on 31 October 2008.  
140. The representative of the United States
 pointed out that his delegation supported China's 
stated objective of environmental protection and rationalization of resources and welcomed the 
clarification by China about the method of calcula ting the inter space ratio for determining maximum 
packaging size.  However, when the excessive packaging requirements had been re-notified, it was 
indicated that the requirement for calculating the packaging cost was no longer voluntary.  He noted that this was a change in position from China's response to comments provided on 5 March 2008.  At 
that time, China had indicated that the provision  on packaging cost was merely a reference and 
compliance with it was not mandatory.  
141. The representative of the United States further not ed that industry alleged that the provision 
limited the total packaging cost to 15 percent of the ex-factory price of the product; this could have an 
adverse effect on the ability of the distilled spirits  industry and other industries to properly deliver a 
well-packaged product to consumers.  His delegatio n also noted that the calculation methodology did 
not appear to adjust for the many costs associated  with the distribution of internationally traded 
products, such as shipping costs, which could make it  more difficult for imported products to comply 
with the 15 percent limit than it would be for dom estic products.  Furthermore, many industries did 
not manufacture their own packaging or have contro l over input prices.  Thus, the requirements could 
put many companies in an uncomfortable position,  since compliance with the 15 percent limit could 
not be within their exclusive control, and trade flow s could be disrupted as a result.  He requested that, 
before the measure was put in place, China re-evaluated  its approach to this technical issue or revert 
to its earlier position that compliance with the 15 percent limit was voluntary.  He also noted 
industry's request that, when the measure was impl emented, an adequate grace period, for example 
12 months, needed to be provided to allow for current packaging stocks to be depleted. 
142. The representative of China
 pointed out that, at the request of the European Communities, the 
comment period on the notified measure had b een extended until 1 December 2008.  Comments 
received would be analyzed and a re ply would be provided.  He str essed that the purpose of the draft 
standard was to protect consumer interests and the environment, which was in line with the legitimate 
objectives in the TBT Agreement.  His delegation welcomed other Members' comments as well as experience-sharing in this regard. 
(iii) Peru – Labelling of footwear (G/TBT/N/PER/19) 
143. The representative of th e European Communities
 pointed out that, in its notification, Peru 
maintained the existing requirement to indicate on the label of footwear the fiscal number of the 
importer.  Her delegation was of the opinion that this requirement created significant costs for the 
producer and exporters, while the information provide d was irrelevant for the consumer.  It would 
therefore be more appropriate to require the indication of the fiscal number on the accompanying documentation, and not on the footwear itself.  More over, the notified text seemed to lay down special 
testing requirements for labelling of footwear ma nufactured abroad and did not seem to accept 
European testing methods.  Her delegation consid ered that these requirements were more trade 
restrictive than necessary and therefore not in comp liance with Article 2.2 a nd Article 5.1.2 of the 
TBT Agreement.  She invited Peru to take in to account the comments sent on 1 October 2008 and 
looked forward to receiving a written reply.  
144. The representative of Peru
 noted that the Enquiry Point was coordinating all the comments 
that had been received and that a reply would soon be provided through the Permanent Mission in 
Geneva.  He took note of the concerns expressed , which would be transmitted to the competent 
authorities in capital.  G/TBT/M/46 
 Page 29 
 
 
  (iv) European Communities – Regulation on the Regi stration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52, Adds 1-5 and Add.3/Rev.1) 
145. The representative of Qatar , speaking on behalf of the Gulf Cooperation Council (GCC), 
expressed concern about the adverse impact that REACH could have on trade in chemicals, including petrochemicals. His delegation was particularly con cerned about the lack of transparency and clarity 
arising from the complexity of REACH and the non- notification of a number of guiding documents.  
The ambiguity of certain provisions made it difficu lt to establish the precise requirements of REACH.  
Uncertainty was also caused by inconsistent impl ementation of REACH across EC members States.  
Other concerns related to the lack of flexibilities for developing countries, despite the particularly 
burdensome nature of the requirements for devel oping countries to ensure compliance (e.g., the 
obligation to test chemicals in EC laboratories).    
146. The regulation would, no doubt, have a significant impact on developing countries.  For the 
implementation of REACH, technical assistance was needed to contribute to  awareness and capacity 
building at the company level so as to better unders tand the legislative framework. This would be an 
appropriate way of increasing transparency.  Given the rigorous requirements imposed by REACH, 
which appeared to be more strict than necessary to  achieve the EC's objectives, the representative of 
Qatar requested the European Communities give  due consideration to the comments of WTO 
Members to ensure that the Regulation was fully consistent with EC's obligations under the TBT 
Agreement.  
147. The representative of Canada
 supported the objectives of protecting health and the 
environment, but reiterated his dele gation's concerns about REACH.  With respect to the issue of the 
Only Representative (OR), he encouraged the Euro pean Communities to explain what measures were 
being taken to protect confidential business informati on that non-EC firms were expected to provide 
to their OR.  On the subject of test methods regul ations, Canada expressed its concern that the test 
methods which would be adopted by the Europ ean Communities had not been approved by the 
OECD.  Therefore, Canada urged the Commission  to postpone the adoption of any unique or 
alternative test methods until their review and acceptance by the OECD.  The representative of 
Canada also requested the European  Communities to clarify what the timeline for adoption of the test 
methods would be. 
148. Furthermore, the Canadian representative ask ed how the pre-registration procedure was 
progressing.  In particular, she asked if the pr ocedure was on schedule and if the European 
Commission foresaw the need of an extension.  Ca nadian industry had indicated that the European 
Chemicals Agency (ECHA) was encouraging compani es not to pre-register until the threshold of one 
ton was meet.  Considering that this could increase co sts for industry that would not be able to benefit 
from the savings of engaging an OR to register fo r them in bulk, Canada requested the European 
Communities to explain what the conditions were to allow a company to pre-register late.  Finally, 
despite the Canadian efforts to in form industry, concerns remained that companies would not be able 
to register in time. 
149. The representative of Egypt  shared many of the concerns expressed by previous speakers, and 
noted that more than fifty per cent of her count ry's chemical exports to  the European Communities 
would be significantly affected by REACH.   She pointed out that many Egypt ian exporters were still 
not ready for the registration procedure due to lack  of information about the relevant substances.  
Accordingly, her delegation requested the Eur opean Communities to extend the period of pre-
registration at least until the end of the first quarter of 2009.  Concerns were also expressed with 
regard to the list of chemical subs tances to be registered, for instan ce, whether it should be considered 
as a component or part of the finished product.  It was also unclear if certain products, such as Portland-cement, dyeing and tanning products in leathe r, needed to be registered under REACH.   G/TBT/M/46 
Page 30  
 
  150. With regard to the issue of the Only Re presentative, Egypt requested the European 
Communities to provide a recommendation list of accr edited ORs, in order to assist the Egyptian 
companies and minimize the time needed for regist ration.  Moreover, the European Communities was 
requested to clarify the definitions of Small and Me dium Size Enterprises (SMEs) so as to apply more 
flexible conditions related to their registration and f ees.  Finally, the Egyptian delegate stressed that 
Egypt still had several concerns related to the cost, complexity and burdensome requirements of 
REACH.  Therefore, the European Communities was requested to provide further technical assistance 
to Egypt and other developing countries. 
151. The representative of Korea
 thanked the European Communities for their prompt response to 
the concerns expressed at the previous Committee m eeting.  However, he stressed that the Korean 
industry was still facing difficulties in complying with the pre-registration procedure.  In particular, 
the Korean representative requested  the European Communities to cl arify whether it was necessary to 
pre-register certain items like microcapsules, whic h could be classified as "preparation in a container" 
or "articles".  Furthermore, he encouraged the European Communities to postpone the implementation 
of REACH and provide more technical assistance to  developing countries, especially to SMEs.  
152. The representative of Japan  thanked the European Communities for organizing the 
information session on REACH, held on 4 November  2008.  However, Japan shared the concerns 
already expressed by other Members.  On the S ubstance Information Exchange Forum (SIEF), the 
Japanese representative requested th at foreign-based firms in the European Communities be treated 
without discrimination, and that their opinions be respected when participating in SIEF.  In this 
regard, he recalled that at the previous Committe e meeting, the European Commission assured that it 
would share information on SIEF.  On the issu e of the uniform application of REACH, the 
representative of Japan recognised that the European Commission was trying to ensure the consistent 
application of REACH throughout EC member States.  However, his delegation was worried that some EC member States would implement REACH in a different way after the pre-registration period, and encouraged again the Commission to en sure a unified implementation of REACH.   
153. The representative of Japan also noted that , according to the REACH regulation, non-EC 
companies represented by a Only Representative needed to pay a fee depending on their business size.  However, since most non-EC companies did busin ess also on non-EC markets, there was concern 
about discrimination against non-EC companies.  Th erefore, the representative of Japan requested the 
European Communities to modify the fee structure so as to calculate only business related to the EC 
market.  Concerns remained that SMEs lacked the means to find appropriate representatives; the 
European Communities was therefore requested to establish a support system which would facilitate 
the work needed to obtain an appropriate OR.  Fu rthermore, the representative of Japan highlighted 
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 (SVHC) on request by the consumer  and within 45 days of receipt of the request.  
However, depending on the article or substance, 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 ade quate information was not provided by the upstream 
suppliers.  He therefore requested the European Communities to postpone the application of Article 
33 of REACH until the deadline indicated by Article 7 of REACH, on 1 June 2011. 
154. Finally, it was noted that the European Chemicals Agency (ECHA) had encouraged 
companies to pre-register monomers in polymers if  they were not sure that the monomers concerned 
would be registered by the end of the pre-regist ration period, on 1 December 2008.  Japan's industry 
expressed concerns that this would impose an excessive burden on enterprises manufacturing or importing in the European market.  The representa tive of Japan therefore requested the European 
Communities to clarify whether the meaning of "r egistered by 1 December 2008" included "pre-
registered by 1 December 2008".    G/TBT/M/46 
 Page 31 
 
 
  155. The representative of Argentina  thanked the European Communities for the comprehensive 
replies received on 27 June 2008, but stressed that the responses received did not satisfy the concerns 
expressed and generated further uncertainty for in dustry seeking to implement REACH.  In this 
regard, he reiterated his delegation's concerns with  respect to the limited cap acity of the European 
Communities to provide uniform and adequate techni cal assistance to industry.  This situation was 
aggravated by the entry into force of the period of pre-registration, and constituted a serious 
impediment to the continued presence of such co mpanies in the European market.  The serious 
transparency problems of REACH showed that this regulation could become an unnecessary barrier to 
trade, since it was not complying with the objectiv es for which it had been created and was instead 
introducing distortions in the trade of chemicals. 
156. The representative of Botswana  associated himself with the comments expressed by previous 
speakers.  While his delegation supported the objec tives of the protection of human health and the 
environment, the complexity of REACH posed enor mous challenges to developing countries such as 
Botswana.  Therefore, the European Communities was requested to provide more technical assistance 
to developing country Members. 
157. The representative of Philippines  supported the objectives of the protection of human health 
and the environment, but also shared concerns rai sed by other delegations on REACH.  In particular, 
he expressed concerns about the consequences of  the OR provision on Small and Medium size 
Enterprises (SMEs), which represented the majority of Philippine's industry. 
158. The representative of Switzerland  expressed support for the objective of REACH to better 
protect humans and environment against the risks associated with the use of chemicals, while 
enhancing innovation.  It was recalled that RE ACH would speed up the process of control and 
evaluation of more than 30,000 substances, and would enhance corporate responsibility in terms of 
marketing and sale of chemical products.  Howe ver, the Swiss delegation believed that REACH 
placed significant burdensome costs, especially on SMEs.  In addition, the complexity of the 
European regulation gave rise to unexpected results  during its implementation.  For example, ECHA 
set out the pre-registration rules for re-imported substances, recovered substances or monomers and 
polymers only on 6 October 2008.  To avoid fu rther trade distortions, the representative of 
Switzerland invited the European Communities to seek  solutions to facilitate the implementation of 
REACH. 
159. The representative of Australia  reiterated her delegation's c oncerns regarding REACH and 
noted its potential to disrupt and impede global trad e in chemicals.  While Australia recognised the 
importance of ensuring a high standard of prot ection for human health and environment, the 
complexity of such a policy and enormous ch allenges faced by non-EC companies remained a 
concern.  Australia was particularly concerned th at REACH would have a disproportionate impact on 
SMEs and that the OR provision could discriminat e against non-EC companies, placing higher costs 
on non-EU producers and manufacturers.  In partic ular, Australian SMEs indicated that the costs 
associated with appointing an OR to pre-register their chemical substances were prohibitive; as a 
result, many SMEs would be unable to continue expo rting into the EC market after 1 December 2008.  
Considering the high costs associated with the re gistration of few chemical substances, it was her 
delegation's opinion that there were other less tr ade restrictive measures to achieve the European 
Communities' health and safety objectives. 
160. In addition, while non-EC companies continued to require further assistance from EC experts 
to ensure a correct implementation of the European  regulation, Australian SMEs indicated that the 
REACH national Help Desks were not in a position to assist them.  The representative of Australia 
welcomed the development of the REACH guidan ce documents by the European Communities but 
noted that they were continuously subjected to change and key issues for non-EC industries were 
unclear.  She also requested that a finalized lis t of chemical substances exempt from REACH be G/TBT/M/46 
Page 32  
 
  provided.  Finally, Australia urged the European Co mmission to take into consideration the concerns 
expressed by Members and adjust REACH implem entation deadlines until these concerns were 
satisfactorily addressed. 
161. The representative of Chile
 raised four specific concerns.  First, there was still lack of clarity 
on the product coverage of the REACH regulation.  While his delegation raised this issue at the 
information session held on 4 November 2008, th e response of the European Commission had not 
been satisfactory.  Second, the European Commun ities was encouraged to clarify the penalties for 
non-compliance according to Article 126 of REACH, which had not been notified yet by EC member 
States.  Third, Chile encouraged the European Co mmunities to explain who could appoint an OR and 
whether it was possible to change the OR without its  consent.  Finally, the representative of Chile 
drew the Committee's attention to the limited cap acity of the European Communities and ECHA to 
provide adequate technical assistance regarding the pre-registration procedure. 
162. The representative of China  thanked the European Communities for organizing the 
information session on REACH.  However, he shared the concerns expressed by previous Members.  With regard to the penalties for non-compliance, he  noted that according to Article 126 of REACH, 
EC member States should lay down the provisions on penalties applicable for infringement of the 
provisions of the regulation, and notify those provi sions to the Commission no later than 1 December 
2008.  Since there was no indication that such penalties were being formulated, the European 
Communities was encouraged to clarify when they would be notified.  This  would be helpful to 
reduce uncertainty about REACH and pr event unnecessary obstacles to trade.   
163. On the issue of special and differential treatme nt, the representative of China requested the 
European Communities to take into account th e special needs of developing country Members 
according to Article 12 of the TBT Agreement.  In particular, it was requested to extend the deadline 
of pre-registration for developing country Members.  China also requested th e European Communities 
to reconsider the criteria of SMEs categories and to  make the staff headcount an optional criterion of 
SMEs under the REACH Regulation.  In addition, China emphasized the importance of transparent 
guideline documents and the importance of good a nd effective operation of the EC Help Desk 
services. 
164. The representative of Mexico
 joined the comments made by previous delegations, and noted 
that concerns remained with regard to the issue of the OR.  In fact, it was his delegation's opinion that 
the requirement of an OR was contrary to the pr ovisions of the TBT Agreement.  In particular, 
Mexico believed that there were less trade-restri ctive alternatives to the OR requirement, such as 
extra-territorial inspections that would enable expor ters to register chemical substances themselves. 
165. The representative of Chinese Taipei  shared the concerns expressed by other Members.  In 
order to provide technical assistance to industry,  she suggested that th e European Communities 
establish a REACH Help Desk in Chinese Taipei.  The purpose of such a Help Desk would be to 
provide guidance on the classification of substances, pr eparations and articles.  The representative of 
Chinese Taipei also recalled that, in order to gath er information from the Substance Information and 
Exchange Forum (SIEF), non-EC manufacturers had no alternative but to appoint an OR.  In this regard, the costs associated with the appointment of  an OR had substantially increased the costs of 
exporting to the EC market.  The European Comm unities was therefore encouraged to explain how 
the OR provision did not discriminate between EC and non-EC based companies.  Finally, the representative of Chinese Taipei encouraged th e European Communities to disclose the non-
confidential information of the SIEF to all non-EC based companies.  
166. The representative of Cuba
 joined other delegations in concerns expressed about REACH.  In 
particular, she was concerned about the complex ity and lack of transparency of REACH, its 
information requirements, the OR provision, the un iformity of the information provided and the  G/TBT/M/46 
 Page 33 
 
 
  overall difficulties faced by SMEs of developing count ries in the implementation of the regulation.  
Also, the Cuban representative drew the Committee's attention to a document (G/TBT/1/Rev.9) which 
contained all the decisions and recommendations adopt ed by the TBT Committee.  She stressed that 
in the Committee's Third Triennial Review (in 2006)  Members had been encouraged to inform the 
Committee of special and differential treatment provided to developing country Members, including 
information on how they have taken into account sp ecial and differential treatment provisions in the 
preparation of technical regulations and conf ormity assessment procedures.  The European 
Communities was therefore encouraged to make best use of the Committee's recommendations and provide a proper response to the concerns raised by  Members.  Finally, the delegation of Cuba joined 
Egypt in requesting the European Communities to extend the period of pre-registration. 
167. The representative of Indonesia
 associated himself with the comments expressed by other 
Members.  While Indonesia supported the objectives of the protection of human health and the 
environment, the disproportionate im pact of such a policy on SMEs a nd the fact that the OR provision 
could place higher costs on non-EC producers and ma nufacturers remained a concern.  Efforts to 
provide technical assistance to developing countries needed to continue in order to enable these 
countries to implement the measures at  issue in the best possible way. 
168. The representative of Thailand  referred to her delegation's previously expressed position on 
REACH.  While Thailand supported the objectives of the protection of human health and the 
environment, the complexity of REACH was be yond the capacity of many developing and least 
developed countries to understand and comply with.  C oncerns were also expressed with regard to the 
OR provision, which created unnecessary and unaffordable  costs for industry.  Such difficulties were 
particularly evident for SMEs, which represented the majority of Thailand's industry. 
169. The representative of South Africa  associated himself with the concerns already expressed by 
other delegations, particularly on the burden on SMEs and the OR provision.  In particular, he 
highlighted the high costs borne by SMEs to comply with the OR provision and requested the European Communities to provide more technical assistance.  Concerns also remained about the 
possibility of changing from the OR.  In fact, it was his delegation's opinion that confidential 
information provided to the former representa tive could prevent companies from seeking the 
assistance of other representatives.   
170.   The representative of Brazil
 shared many of the concerns previously expressed by others, 
stressing the difficulties and the costs imposed by th e registration procedure, testing, and the OR 
requirement, especially in the case of SMEs. 
171. The representative of the United States  noted that his delegation shared the EC's interest in 
protecting human health and the environment.  However, concerns remained that the REACH 
regulation appeared to be overly broad and to adop t a particularly costly, burdensome, and complex 
approach that could disrupt and distort global trade.   In particular, the re presentative of the United 
States noted that the number of concerns raised  by industry was growing exponentially as the pre-
registration period progressed.  Since all of those con cerns cantered around the lack of transparency of 
REACH, he had found disappointing that the Eur opean Communities had not responded to a request 
for bilateral technical talks made by the United States and was attempting to keep REACH off the 
agenda of the Transatlantic Economic Council discussions.   
172. Many concerns remained both within and outside the European Union, including: are blood 
and blood derivatives covered by the regulation?  Do re-imported substances need to be pre-registered 
a second time?  What substances in articles such as autos are intended for release?  Where does the 
dividing line between a substance and a prepara tion lie?  Other issues were, for example, the 
justification of registration requirements for reac ted monomers in polymers and lack of information 
on the penalties for non-compliance.  It was noted th at the failure of the European Communities to G/TBT/M/46 
Page 34  
 
  clarify and remedy such issues and others would l ead to serious trade disruptions and even potential 
adverse impacts on public health and safety. 
173. With respect to the issue of cosmetics, the re presentative of the United States recalled that the 
European Communities had already recognized th at REACH could discriminate against foreign 
cosmetics producers.  Therefore, he requested th e European Communities to provide legal certainty 
that non-EC cosmetics producers would be able to pr e-register their substances, participate in the 
SIEFs and continue shipping into the EC market.  In particular, the European Communities was invited to clarify when and how the European Co mmission would provide legal certainty on this 
issue, whether through an amendment or corrigendum to REACH or through a binding legal opinion.  It was also stressed that some US companies had al ready stopped shipping cosmetics to the European 
Communities.  If this situation remained unresolved, up to US$4 billion worth of cosmetics exports to 
the European Communities could be negatively impacted.   
174. On the Only Representative provision, the repr esentative of the United States welcomed the 
fact that the European Communities determined that non-EC manufacturers who did not directly export to the European Union would be able to appoint  an OR to register their substance.  However, 
this did not address the fundamental structural pr oblem with the OR requirement.  In fact, this 
provision raised serious concerns for non- EC supply chains, because sensitive commercial 
information could be compromised depending on who in the supply chain appointed the OR and how the supply chain was set up.  It was highlighted th at this problem was leading several companies to 
consider as part of their sourcing policies whether they needed to start purchasing more of their inputs from companies located in the Europ ean Union.  Foreign chemical dist ributors were being particularly 
impacted since they were not permitted to appoint an OR.  In this regard, it was also recalled that one 
of the primary objectives of REACH was to incr ease the competitiveness of the European chemical 
industry. 
175. With respect to the "authorization candidate lis t", the United States de legation was concerned 
that this list, officially known as the Substances of Very High Concerns (SVHCs) list, was hazard 
based and would be used as a "black list".  To a ddress this problem, the representative of the United 
States had urged the European Communities to provide guidance on the status and purpose of the candidate list prior to the publication of the ca ndidate list and candidate substance dossiers.  
Specifically, the European Communiti es had been encouraged to make clear that: (i) only substances 
on the final authorization list would be subject to au thorization and related restrictions, (ii) that ECHA 
would evaluate use-based risk assessment inform ation to determine which substances would be 
subject to authorization; (iii) that producers should not use the inclusion 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. 
176.   With respect to the burden on SMEs, the repr esentative of the United States stressed that 
many SMEs, who were engaged in selling their products domestically, did not have the resources or 
the ability to discern the data necessary to ensure complete and accurate registration under REACH.  
It was further highlighted that this was a problem for both developed and developing countries.  Unlike large multinationals, SMEs would be less likel y to have a European presence and, therefore, 
would effectively have little choice but  to appoint an Only Representativ e to register their products; or  
their downstream user would find another supplier who would do it.  It was noted that registration and 
testing fees, even with the reduced registrati on fees for SMEs, could easily exceed US $50,000 per 
substance.  If a particular company used 400 subs tances to manufacture a particular fragrance, which 
was not uncommon, the cost could be prohibitive.  The delegate of the United States stressed that 
many companies would no longer be able to ship all of their products, particularly small, niche 
products, to the EU market, since they lacked bot h the manpower and financial resources to register 
all of the necessary substances.  Therefore, it was his delegation's opinion that the regulation would  G/TBT/M/46 
 Page 35 
 
 
  increase the market share of large chemical companies and drive many SMEs out of the EU market.  
Finally, the representative of the United States stat ed that his delegation would reflect on the ideas 
expressed by some delegations for addressing different ly the issue of the On ly Representative.  The 
European Communities was urged to take into cons ideration the concerns which had been expressed 
by its trading partners and other interested parties,  and to ensure a meaningful opportunity to reflect 
the views of other governments and stakeholders in the process. 
177. The representative of the Russian Federation, speaking as an observer , joined other 
delegations in concerns expressed about REACH.   While the Russian Federation supported the 
objectives of the protection of human health and the environment, REACH was probably more trade 
restrictive than necessary to fulf il the legitimate objective of ensuring high standards of human health 
safety and environmental protection.  In partic ular, the representative of the Russian Federation 
expressed concerns about the possible discrimination between EC and non-EC based companies.  While EC based companies could register their subs tances, non-EC companies had to rely on different 
EU importers to register the same substances.  Th is approach resulted in additional burden for non-EC 
companies, increased costs and disclosure of conf idential information.  Moreover, non-EC companies 
could not participate in SIEF and consortia.  The Russian Federation believed that such treatment 
could be seen as less favourable than that acco rded to like products of national origin. 
178. Moreover, the representative of the Russian Fe deration considered that the complexity of 
REACH could lead to uncertainty for chemical produ cers and to arbitrary decisions when applied in 
practice.  Considering the previous discussi on on nickel compounds, her delegation expressed 
concerns about the fact that the European Comm unities would adopt the same simplified approach for 
the classification of substances also in the framewo rk of REACH.  This would result in decisions 
taken without sufficient scientific data.  Finally,  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 in ch emicals.  The European Communities was therefore 
encouraged to take into consideration the concerns  which had been expressed by its trading partners, 
and to ensure a meaningful opportunity to reflect their views in the process. 
179. The representative of the European Communities
 thanked the delegations which raised 
questions about REACH.  She pointed out that the pre-registration period under REACH had started on 1 June 2008, and ended on 1 D ecember 2008.  She also noted th at the European Communities was 
doing everything to facilitate the pre-registration pr ocess.  In fact, her delegation had organized an 
information session on 4 November 2008, where Members could ask specific questions to EC experts.  
The European Communities would carefully consider  the questions and concerns raised by other 
delegations. 
180. The representative of the Europ ean Communities noted that th e Only Representative was not 
an obligation under REACH, but rather a possibility given to non-EC manufacturers.  In fact, the OR 
provision was introduced in REACH to address some of the concerns that had been expressed by 
trading partners, particularly regarding the protect ion of confidential business information.  It was 
further stressed that the obligation to register substances manufactured outside the European Union 
fell only upon the European importers.  Therefore, the claims that there were higher costs for non-EC 
based companies than for EC based  companies were not correct.  On the proposal of inspections 
outside the EC territory, the representative of the European Communities stated  that such a provision 
would be in violation of basic principles of intern ational law.  With respect to the questions on the 
possibility of changing the OR, she noted that a transfer of the registration would be possible by 
submitting an update to the earlier dossier.  This had been clarified in the guidance documents on 
registration.  However, the former Only Representa tive would have to agree with the change, because 
the registration dossier belonged to the OR that had made the submission.  Sh e further clarified that 
these aspects were to be covered in the privat e arrangements between the non-EC manufacturers and 
the Only Representative.  In this regard, non-EC based companies could impose conditions that would G/TBT/M/46 
Page 36  
 
  require the OR to agree to a subsequent change.  Moreover, since the appointment of an OR was 
purely voluntary and the relation between the entity that appoints the OR and the OR itself was not governed by REACH, the European Communities coul d not provide a list of representatives that were 
considered to be appropriate or sufficiently knowledgeable.  Regarding the concerns about the 
protection of confidential business information, the EC representative explained that also such aspects 
could be covered in the private arrangements between the non-EC manufacturers and the Only 
Representative. 
181. On the issue of pre-registration, the represen tative of the European Communities noted that 
over 800,000 pre-registrations  had been received so far.  With respect to the request whether it was 
necessary to pre-register substances that were re-i mported or recovered, or substances in monomers 
and in articles, she noted that REACH foresaw ex emptions from the obligation to register in these 
cases, provided certain conditions were met (for exam ple, that the relevant substance had to be 
previously registered with ECHA).  She explained that the interpretation that pre-registration was 
required to benefit from the exemption to register wa s consistent with the e xplanation provided in the 
first version of the guidance documents; however , the European Communities would take into 
account the comments received and would examine them in detail. 
182. On the fees regulation, the EC representative not ed that the requests from some delegations 
that fees and charges be applied equally to EC based  and non-EC based companies showed that  there 
could be a misunderstanding about who had to re gister and who was a member of the Substance 
Information Exchange Forum (SIEF).  It was theref ore recalled that registrants (and, consequently, 
members of SIEF) were only EC based companies, be it manufacturers, importers, or Only 
Representatives.  It was also stressed that ORs were treated in the same way as manufacturers and 
importers established in the European Union.  On the request to share some of the non confidential 
business information obtained by the SIEFs, the Eu ropean Communities representative pointed out 
that one of the objectives of REACH was to increase the level of information available about chemicals and that therefore such information w ould be freely published on the ECHA website in 
accordance with Article 119 of the REACH regulation. 
183. On the issue of SMEs, the representative of  the European Communities explained that the 
meaning of the term SME had been clearly de fined in the Commission's recommendation on the 
definition of SMEs.  Such uniform interpretation ensu red that all companies would be treated equally.  
The European Communities was read y to provide the full text of this recommendation and extra 
informative material to all interested parties.  W ith regard to the fees to be applied for SMEs, it had 
been suggested that the reduction for SMEs should not be based on the entire turnover of the non-EC 
based company.  In this regard, the EC representa tive noted that, in effect,  when a manufacturer 
established outside the EU decided to appoint an OR , the assessment of the SM E status thereof for the 
purposes of applying the reductions of fees would be  done on the basis of the turnover of the company 
represented (i.e. including also business which was no t linked to the exports of chemicals to the EC 
market).  However, she stressed that the same principle applied to EC-based companies as the 
consideration of their SME status would also have to consider the turnover linked to business outside 
the EU.   
184. With regard to the questions on the candida te list, it was noted that the European 
Communities had been requested to provide guidance on the status of the candidate list and to clarify 
that substances contained in such list were not subj ect to authorization.  In this regard, the EC 
representative noted that the REACH regulation alread y indicated, clearly, that an authorization was 
only required for the substances included in Annex XI V (List of Substances Subject to Authorisation). 
185. 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 in all member  States without the need of any national measure for the transposition  G/TBT/M/46 
 Page 37 
 
 
  thereof.  Furthermore, it was stressed that EC memb er States could not depart from the content of the 
regulation by adopting different national measures. 
186. On the issue of penalties for non-compliance to REACH, the EC representative clarified that 
sanctions fall under the competen ce of EC member States and information on sanctions would be 
published in their national official journals accordi ng to each member State's legislative system.  It 
was stressed that sanctions have to be sufficiently  serious as they had to dissuade stakeholders from 
infringing on the rules set by REACH. 
187. An expert from the DG Environment replied to so me specific questions raised by delegations.  
On test method regulation, he said that the European Commission supported the approach of 
implementing OECD methods wherever possible.  However, under exceptional circumstances the 
European Commission could have to consider to  propose a specific alternative method as there are 
animal welfare considerations that, in accordan ce with REACH, the Commission should take into 
account. 
188. With regard to the question on late pre-registra tion, the EC representative referred to Article 
28.6 of the REACH regulation, which outlined a clear procedure for late pre-registration.  It was his 
delegation's opinion that companies were perhaps not aware of the option in Article 28.6, which 
allowed any importer who had not imported a substance after 1 June 2008 in volumes above one ton 
to pre-register after the deadline of 1 December  2008 within six months of his first import.  
189. The EC representative noted that the Eu ropean Communities fully understood the 
requirements of the registration process; however, he  recalled that under the former EU legislation 
there were already obligations for the importers to  know which substances they were importing.  For 
example, if a new substances not in EINECS was imported in volumes above 10 kilos per year, the 
importer was required to make a no tification (a so-called mini notification).  Furthermore, if an 
importer imported any substance listed in EINECS  in volumes above 10 tonnes, there was also a 
notification requirement; it was therefore necessar y to know which chemicals were contained in the 
preparations being imported.  In other words, th e obligation to know what was imported in the EU 
market had existed for many years. 
190. On the specific question about microcapsules rais ed by Korea, the EC representative pointed 
out that more information was needed in order to reply to the question. Lack of necessary information 
was  also often the reason why the European Agen cy on Chemicals (ECHA) was sometimes not able 
to answer clearly to a specific enquiry.  The same applied for the issue of Portland-cement which had 
been raised by the delegation of Egypt.  On the i ssue of the substances exempted from the obligation 
to register, the EC representative recalled that An nex IV contained a list of such chemicals, and 
Annex V contained categories of substances exempted.  In this regard, he noted that the REACH Help 
Desks would answer questions related to these exem ptions, provided they we re given all relevant 
information, .  For example, it was noted that bloo d, as a natural substance, was covered by Annex V, 
but that the question whether it could benefit from the exemption would also depend on whether the 
blood had undergone processing (as indicated in Annex V). 
191. With regard to the issue of the frequent revi sion of guidance documents, it was clarified that 
most of the revisions were made to add information related to specific questions received.  Regarding 
the request to have REACH Help Desks in third- countries, the EC representative took note of the 
request made.  On the issue of grouping approach, it was recalled that under REACH there was an 
obligation to consider testing only as the very last resort, while first considering all the other 
possibilities to obtain information with a simila r scientific level and quality.  Among those 
possibilities, there were also the grouping approach and "read-across".  Finally, the EC representative 
clarified that the European Commission had unde rstood the issue raised by the US delegation 
regarding cosmetics, and was working with EC me mber States to facilitate the registration of the G/TBT/M/46 
Page 38  
 
  substances concerned.  However, he stressed th at REACH was not discriminatory, and that US 
companies had been asked to provid e information about the substances concerned in order to give the 
EC the possibility to assess the scope of the issu e raised, but no information had been provided. 
192. With respect to the possibility of inspecti ng enterprises outside the EC territory, the 
representative of Mexico
 drew the EC delegation's attention to Articles 2.7 and 6.4 of the TBT 
Agreement.  In particular, he requested the Eu ropean Communities to explain how such provisions 
could not be applied outside  the territory of a party.  The representative of Mexico also brought to the 
attention of the Committee the relevant provisi ons on inspections under the SPS Agreement. 
193. The representative of Australia  joined the comments expressed by Mexico and recalled that 
there was no violation of international law in inspecting enterprises outside the EC territory.  
Regarding the EC statement that there was no oblig ation on companies outsi de the European Union 
under REACH, it was his delegation's understanding that a non-EC based company had either to 
establish within the European Union or appoint an On ly Representative.  In this regard, the Australian 
representative stressed that the costs faced by SMEs in appointing an OR clearly showed the 
differential treatment between EC and non-EC based companies.  She also emphasized that SMEs had 
a very limited time to pre register. 
194.   The representative of Egypt  thanked the European Comm unities for their response.  
However, concerns remained with regard to the i ssue of the Only Representative, the extension of the 
pre-registration period beyond 1 Dece mber 2008 and the need of special  and differential treatment to 
developing countries. 
195. The representative of the United States  shared the concerns expressed by previous speakers 
with regard to the EC statement that there was no obligation on non-EC based companies under 
REACH.  Considering that small non-EC based comp anies could not afford to open a facility in the 
European Union, it was his delegation's understanding  that the only remaining option was to hire an 
Only Representative or stop shipping to the European Union.  With regard to the issue of cosmetics, 
the representative of the United States stressed that  the burden was not on foreign companies to 
provide information; rather, it was the European  Communities' responsibility to make sure the 
regulation was clear and not discriminatory. 
196. The representative of Pakistan  joined the concerns already rai sed by Egypt about the need of a 
special and differential treatment for developi ng countries, and the comments expressed by the 
delegation of Mexico about the possibilit y of having international inspections. 
197. On the issue of inspections outside the EC territory, the representative of the European 
Communities  noted that voluntary agreements for the ex change of inspections already existed.  
However, the kind of inspections that would be required for the implementation of REACH outside 
the European Union were different, including unan nounced inspections on site in private entities.  
This was illegal under the law of most of the Memb ers.  On the Only Representative provision, the 
EC representative stressed again that it was not a mandatory requirement and that the obligation to 
register substances manufactured outside the Eur opean Union fell only upon the European importers.  
Also, she recalled that an extension of the pre-regi stration period was not foreseen.  With respect to 
the issue of cosmetics, she recalled that REACH was not discriminatory, and that the European 
Commission was working to facilitate the regist ration of the substances concerned within the 
framework of REACH.   
198. Finally, regarding the need of special and di fferential treatment and technical assistance to 
developing countries, the EC representative recalle d that the primary objective of REACH was the 
protection of human health and environment; no ex ceptions for developing countries could therefore 
be provided for requirements such as the pre-regi stration/registration obligation.  However, by  G/TBT/M/46 
 Page 39 
 
 
  developing the guidelines on the implementation of REACH, the European Communities also gave 
assistance to developing countries.  The repres entative of the European Communities invited 
Members having specific needs for technical assist ance programs, to direct their requests to the 
respective delegations of the European Commissi on in their country.  She recalled that certain 
programmes were already carried out in cooperation with UNIDO.  
199. The representative of Mexico  requested further clarification on the issue of international 
inspections, and highlighted that similar mechanisms  of international inspections were already in 
force.  As an example, he drew the Committee' s attention to the situation of his pharmaceutical 
industry, and introduced a document recently submitted to the Committee in this regard 
(G/TBT/2/Add.14/Suppl.1). 
200. The representative of the United States  raised again the issue of the Only Representative and 
stressed that the EC’s statements did not reflect how the relevant supply chains actually operated in 
practice.  The importers tended to be downstream u sers of chemical substances and, as such, lacked 
the requisite technical knowledge to register thos e chemical substances.  At the same time, the 
importers were often the largest players within th eir supply chains and, thus, had the power within 
those supply chains to insist that their smaller, upstream suppliers register the substances (or risk 
losing the business) which, in most cases, woul d require those suppliers to appoint an Only 
Representative. 
201. The representative of Egypt  raised again the issue of extension of the pre-registration period, 
and requested the European Comm unities to clarify the reasons for not granting such extension, 
especially for developing countries.  On the issue of special and differential treatment, he drew the 
attention of the Committee to Article 12.3 of th e TBT Agreement, which requires Members to take 
into account the special needs of developing country  Members in the preparation and application of 
technical regulations, standards and conformity asse ssment procedures.  The representative of Egypt 
asked the European Communities to clarify how they intended to apply this provision of the TBT Agreement in the implementation of REACH. 
202. The representative of China
 joined the comments expressed by the delegations of Cuba, 
Mexico, Egypt and other developing country Members with respect to the issue of special and differential treatment.  He also drew the atten tion of the Committee to Article 12.3 of the TBT 
Agreement, and recalled that the de legations of Mexico, Cuba and China had already raised this issue 
at the previous Committee meeting without obtaini ng any response from the European Communities.  
Furthermore, the Chinese representative clarified that  special and differential treatment to developing 
country Members did not mean to exclude products  or enterprises from the provisions of REACH.  
Therefore, concerns remained about the pre-registra tion period, the criteria for the definition of SMEs 
and the fees for developing country Members, especially for SMEs. 
(v) United States – Country of Origin Labelling (COOL) (G/TBT/N/USA/281 and Add. 1) 
203. The representative of Canada
 recalled that her delegation had expressed concerns about the 
US mandatory country of origin labelling (COOL) pr ogram, as set out in the 2008 Food Conservation 
and Energy Act.  Concerns had been raised at TB T Committee meetings in J une 2002, March and July 
2003, March and June 2005,  and July 2007.  Comments had also been submitted to the formal USDA 
rulemaking process, requesting that flexibility be ap plied in implementing the rule so as to minimize 
any disruptions for Canadian industry. 
204. The representative of Canada noted that the st ated intent of the measure was to provide 
consumers with additional information on which to  base their purchase decisions.  However, she 
stressed that the United States had yet to provide  evidence that the mandatory COOL program would 
benefit consumers as a retail la belling program.  On the contrary , domestic support for the program G/TBT/M/46 
Page 40  
 
  did not appear to be consumer-driven, but rather, producer-driven.  She stressed that the mandatory 
country of origin labelling requirements implemen ted for fish and shellfish in 2005 had created 
considerable administrative burdens for Canada's fishing industry, especially in small and medium 
enterprises.  It had also created a competitive di sadvantage for these protein products.  She wondered 
why the new regulation distinguished between wild  and farm seafood products, given that the HS 
code did not allow for such a distinction, and how this rule would be implemented. 
205. It was further highlighted that although mandato ry COOL for beef and pork had only been in 
place for one month, Canada's industry was alr eady reporting unfavourable treatment, as several 
major US processors had indicated that they would no  longer be buying Canadian animals as a result 
of COOL.  In Canada's view, the mandatory COOL program imposed an unnecessary technical barrier 
to trade and could therefore be inconsistent w ith the US obligations under the TBT Agreement, 
particularly as voluntary alternatives existed.  Sh e requested that the requirements for the current 
mandatory COOL program be abandoned for a ll products, including fish and shellfish. 
206. The representative of Mexico
 supported Canada's views.  In comments sent to the United 
States on 29 September 2008, it was stressed that, in Mexico's view, this system did not appear to 
have the intention to protect the consumer, but ra ther, the manufacturer. Additionally, he noted that 
the US regulation was not based on the relevant inte rnational Codex standard on pre-packeged goods 
and food.  His delegation was willing to discuss the matter with US authorities and was expecting that 
comments be taken into account. 
207. The representative of the United States  noted that, further to the 2008 Farm Bill, the 
amendments to the COOL programme were now la w in the United States.  The United States 
Department of Agriculture (USDA) had published an  Interim Final Rule (IFR) in the US Federal 
Register on 1 August 2008 in orde r to implement those changes.  Comments on the IFR were received 
until 30 September 2008.  In accordance with the legislation, the mandatory COOL program had been implemented on that date, with its "interim" st atus enabling USDA to continue considering the 
comments received and making revisions to the rule.  He pointed out that the Interim Final Rule and 
related guidance had incorporated additional chang es sought by several commenters.  For example, 
the measures simplified the labelling for meat from multiple countries of origin, ensured that meat 
from animals imported for immediate slaughter wa s not treated less favourably with respect to 
labelling than meat from animals of exclusively US origin, and reduced the potential civil penalties by 
90 percent.  
208. It was further highlighted that USDA had also provided six months from the date of 
implementation of the IFR to conduct education a nd outreach.  Three information sessions had been 
conducted since 30 September 2008, in  an effort to assist industry to achieve compliance.  The grace 
period was also intended to allow covered commoditi es already in the chain of commerce, for which 
no origin information was known, to have sufficient time to clear the system.  USDA had also provided guidance materials and resources to interested parties via the USDA website.  
209. The representative of the United States understood th at there continued to be concerns among 
trading partners, and stressed that his delegation remained committed to implementing COOL in a fair and balanced manner, to continuing meeting with interested parties to discuss comments and take 
them into account in revising the interim final rule , and to helping ensure that actors in the supply 
chain could comply with the new requirements.  He  noted that Canada's comments on fish and shell 
fish would be transmitted to competent authorities for response. 
(vi) Brazil – Toys (G/TBT/N/BRA/259) 
210. The representative of the European Communities
 recalled that concerns had been expressed 
about the conformity assessment systems applied to imported toys in Brazil.  His delegation was of  G/TBT/M/46 
 Page 41 
 
 
  the opinion that those rules granted less favourab le access to the Brazilian market for foreign toy 
suppliers compared to domestic toy suppliers.  He recalled that, at the previous meeting of the TBT 
Committee, the representative of Brazil had indi cated that changes to the rules were under 
consideration.  He sought an update from Brazil on th e state of play, an indication of what types of 
measures had been considered and also  of the timeline for their adoption. 
211. The representative of China  believed that the measure by Brazil violated the provisions of 
non-discrimination and less trade restrictiveness under the TBT Agreement.  The Chinese industry 
had indicated that the new Brazilian procedures added another 70 days for pro ducts to flow from the 
plant to the warehouse, which made the process 140 days long.  Moreover, the certification process 
had added an additional 25 days.  The Chinese indust ry estimated that the value of lost sales was 
USD 20 million due to the difficulty to meet the regulation requirements.  His delegation understood 
that Brazil would notify the amended regulatio n and comments would be made on this new 
notification.   
212. The representative of Thailand  recalled that comments had been sent to Brazil and concerns 
raised at TBT Committee meetings in March and Ju ly 2008.  In the comments sent in January 2008, 
her delegation had stressed that the Brazilian decree  was inconsistent with the TBT Agreement. In 
particular, enforcing certification System 7 only on  importers was discriminatory in practice, and 
recognizing only tests carried out by INMETRO laboratories created unnecessary trade obstacles to importers.  She recalled that Brazil had been re quested to consider accepting testing of foreign 
laboratories accredited to ISO/IEC 17025, or adoptin g alternative quality control approaches such as 
market surveillance for both imported and local prod ucts, that would ensure both safety objective and 
equal treatment.  A subsequent request had been made on 26 February 2008 for cooperative direction 
to help ease the problems of Thai exporters.  
213. The representative of Thailand noted that, in its reply, Brazil had stated that the measure did 
not create an unnecessary and illegitimate obstacle to trade and that Systems 5 and 7 only differed in the number of samples to be tested in a lot, and pointed out that it would accept only testing in 
laboratories accredited by INMETRO.  She stressed that the reply had failed to clarify the 
discriminatory aspect of the decree.  On the cont rary, it had confirmed the unnecessary difficulties for 
exporters who were subjected to the unequal practice and selec tive recognition of conformity 
assessment procedure.  She recalled that, at th e TBT Committee meeting in March, Thailand had 
raised concerns about Brazil's disc riminatory enforcement of its certification system.  Brazil had been 
requested to consider accepting test reports of foreign labs accredited to ISO/IEC 17025 under an 
internationally recognized umbrella such as ILAC/ IAF, to which Brazil was also a signatory.   
214. It was further recalled that, at the TBT Co mmittee meeting in July 2008, as no changes had 
been made to the Brazilian measure, concerns were  reiterated, in particular about less favourable 
treatment towards imports - in breach of Article 5.1.1 - and the creation of unnecessary obstacles to trade in violation of Article 5.1.2, despite other WTO-consistent alternative measures available, such 
as testing in the country of export.  Brazil had also  been requested to provide a written reply to the 
comments submitted.  However, no su ch reply had been received.  
215. The representative of Thailand stressed that th e measure had been in place since 16 October 
2007, which was a long period for a temporary measur e.  Her delegation was of the view that the 
measure was in violation Article 5.1.1 of the TB T Agreement, since Brazilian conformity assessment 
procedures were applied so as to grant access for importers under conditions less favourable than 
those accorded to local manufacturers.  In partic ular, Brazilian manufacturers could choose System 5, 
which was pre-market approval, one-time sampling fo r type testing.  However, importers had use 
System 7 only, where every lot had to be sampled, and tests could be done in Brazil only; this was not in line with Article 5.1.2 of the TBT Agreement.  Brazil's measure was applied more strictly than 
necessary to give Brazil adequate confidence that im ported toys conformed to its safety requirement.  G/TBT/M/46 
Page 42  
 
  216. The representative of Thailand further highlighted that every import lot had to be held at the 
port of entry, await sampling and testing by INME TRO only, and be detained until the test results 
were obtained.  In the meantime, importers were in uncertainty about the test results, while costs kept 
increasing as the test was delayed and storage prolonged .  She stressed that this was not in line with 
Article 5.2.6 of the TBT Agreement, as the sitin g of facilities used in conformity assessment 
procedures and the selection of samples were such as to cause unnecessary inconvenience to 
importers.  
217. Moreover, since Brazil required that the test be conducted by INMETRO accredited 
laboratories only, and did not recognize laboratory accreditation under international umbrella such as 
ILAC/IAF, reports from exporters showed that the toy import process that used to take 50-70 days 
now took 140-150 days.  Excessive costs were added to the process, related to product certification, 
storage, demurrage, amounting to 30 per cent of FOB.  The testing capacity of Brazil was also questioned and test result delays were the main technical barrier for all exporters.  
218. The representative of Thailand recalled that, at the July 2008 meeting of the TBT Committee, 
Brazil had indicated that a new and definite system of conformity assessment procedures for toys was 
under consideration.  She sought an update about the definite timeframe  for this system and whether it 
would comply with the TBT Agreement.  She str essed that, since Brazil's consideration of a new 
system took time, the temporary measure should immediately be reviewed, and foreign test reports issued by accredited laboratories should be acce pted.  Market surveillance was also a non-
discriminatory and effective system to protect health.  Thailand had indicated to Brazil that, if no changes were envisaged or if foreign test reports would not be accepted, Brazil would be requested 
under Article 6.3 of the TBT Agreement to enter in to discussion towards a bilateral arrangement that 
would benefit both Brazilian consumers and Thai exporters.  
219. Finally, the representative of Thailand sought  a written reply to the following questions: 
(i) had the decree been revised since the July 2008 meeting of the TBT Committee? (ii) if so, could 
the revision be described and a copy provided? (iii) if not, had INMETR O initiated any action or 
process for the revision? (iv) could any description of the process be provided, together with any 
relevant draft text? (v) if no revision process ha d been initiated, when would INMETRO begin the 
process? (vi) would Brazil enter into a bilateral di alogue with Thailand on the matter?  She stressed 
that her country shared the objective of health and safety protection, but believed that discriminatory 
or trade restrictive practices would not serve the purpose.  Her delegation was of the view that this regulation together with its conformity assessment procedures had been adopted, prepared and applied 
with the effect of creating unnecessary barriers to trad e, contrary to the principle of good regulatory 
practice.  
220. The representative of Brazil
 pointed out that the regulation on toys had been adopted on an 
emergency basis in order to cope with a situati on of lack of confidence regarding the safety of 
imported toys.  He recalled that in the year 20 07 several cases of non-compliance, recalls and 
accidents had been reported.  Therefore, Brazilian authorities had decided to require that imported 
toys be tested under System 7 of certification, which,  in his delegation's view, did not constitute a less 
favourable treatment to importers.  In the previous  TBT Committee meeting, Brazil had noted that the 
current regulation was being revised.  He inform ed the Committee that the process of revision was 
complete and that Brazilian authorities had take n into consideration the concerns expressed by 
Members in the Committee and in bilateral meetings .  A draft of the new regulation was published for 
public consultation and copies of the new draft wo uld be provided.  According to the draft new 
regulation, both domestic and imported toys would be allowed to use System 5 of certification.  
Moreover, tests performed by laboratories accredited by ILAC would be accepted again.    G/TBT/M/46 
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  (vii) Brazil – Wines (G/TBT/N/BRA/238; G/TBT/BRA/289) 
221. The representative of the European Communities  referred to the Brazilian Normative 
Instruction 33, regarding mandatory analytical parame ters for analysis of certificates of origin for 
imported wine.  She recalled that, at the previ ous meeting of the Comm ittee, her delegation had 
indicated that no clarification had been receive d as to why the Brazilian authorities required the 
analysis of some parameters which were not provide d for in the templates of analytical certificates for 
trade in wines set by the International Organization of Vine and Wine (OIV).  She invited Brazil to 
explain the reasons for departing from the requirement s set at international level.  Her delegation was 
also interested in receiving additional informati on on the public consultation that was launched on 
2 June 2008 on import requirements for wines and its potential impact on the provisions of the 
Brazilian Normative Instruction.  
222. The representative of the United States  shared some of the concerns expressed.  He noted that 
both the Brazilian measure on wine and the measure on spirits11 could restrict trade as many of these 
proposals contained elements which varied from in ternationally-accepted standards, or set out a 
unique approach to defining values and parameters for quality and identity.  For both measures, he 
sought clarification on Brazil's objective.  He also  sought an explanation as to why both measures had 
also been notified as SPS measures. 
223. Specifically, with respect to wine, the Unite d States had three main concerns with the 
proposed requirements.  First, the registrati on requirements appeared to be burdensome and 
duplicative.  Brazil was invited to clarify why th e Ministry of Agriculture, Livestock, and Food 
Supply (MAPA) was proposing to require foreign wineri es to register and have their premises subject 
to inspection, in addition to complying with the existing requirement for registration by the local 
importer.  Second, it appeared that minor modificati ons made to the wine label, such as a change in 
the label's colour, would require re-registration of the wine and Brazil was requested to clarify the purpose of this requirement.   Third, it was noted that geographic and regional factors could influence 
the alcohol content of wine.  Thus, clarificati on was sought as to why Brazil was proposing to limit 
the alcohol content of wine to 14 percent by volu me unless it carried a statement clarifying that the 
wine had "typical" or "distinctive" characteristics of a region.  Such a measure could have the effect of 
blocking imports. 
224. The representative of Brazil
 explained that the intention of the proposed measure was to 
expedite wine imports.  In particular, the measu re was intended to shorte n the period during which 
imported wines were kept stored while official la boratories performed analytical tests.  Given the 
large number of imports, official laboratories we re operating over their capacity, and delays were 
being reported. Therefore, the regulation allowed th e acceptance for test carried out abroad.  He noted 
that the regulation notified as G/TBT/N/BRA/289 w ould replace the above mentioned regulation.  
Regarding the objectives of the analytical parameters , he pointed out that analytical parameters for 
chemical components were an important instrument to  attest the quality of spirits, including to verify 
raw materials, thereby preventing fraud in production and process.   
(viii) Brazil - Regulations on Identification and Qua lity Standards of Et hyl Alcohol and other 
Spirits (G/TBT/N/BRA/276-278 and Suppl.1) 
225. The representative of the European Communities  recalled that her delegation was concerned 
about the fact that the draft measures notified by Brazil seemed to divert from the international 
practice and could constitute an unnecessary barrier to trade.  For example, the draft standards defined 
spirit drink categories in terms of chemical compone nts rather than defining them in terms of raw 
materials and production process, as was the commonl y accepted practice.  Furthermore, the alcohol 
                                                      
11 See below, paragraph 48. G/TBT/M/46 
Page 44  
 
  content requirement established by the proposed me asure also diverged from internationally accepted 
standards.  The draft regulations also seemed to rest rict the use of certain flavouring in spirit drinks 
exported to Brazil.  She sought confirmation from Br azil that these requirements would only apply to 
domestic products and not to beve rages from third countries, and th at these could enter the Brazilian 
market if they complied with the requirements set in the country of origin.  She also invited Brazil to 
indicate whether the notified measures would be modified as a result of the public consultation 
process that had been launched on 24 April 2008. 
226. The representative of Mexico
 recalled the concerns expressed by his delegation on the 
Brazilian regulation, in particular with respect to tequila.  Comments had been submitted to the 
Brazilian authorities and various bilateral meetings had taken place.  Howeve r, concerns remained 
with respect to the consistency of the regulations w ith the TBT Agreement.  He sought clarification on  
the scope of these measures and on the applicability to products originating from third countries.  He 
invited Brazil to provide a response to the comme nts submitted and a confirmation that the measure 
did not apply to imported products. 
227. The representative of the United States  noted that, with respect to spirits, Brazil had chosen 
different requirements from what normally were used in the market. For example, its proposed 
minimum alcohol content requirement was different  from globally accepted standards.  In addition, 
Brazil was proposing a maximum alcohol content level,  which would be unique in the world.  He 
sought clarification as to why Brazil would set a maximum limit, given that no health and safety 
concerns had been identified.  
228. Furthermore, it was noted that Brazil's proposals on both whisky and rum specified analytical 
parameters for higher alcohol levels.  Such alc ohols were naturally occurri ng constituents produced 
during the fermentation, distillation, and maturation processes that did not raise any health and safety 
issues.  The representative of the United States re called that, for this reason, in September 2006 
(following a similar discussion in the TBT Committee) , China had agreed to withdraw its proposed 
limits on higher alcohols in distilled spirits in line with  international practice, including the Guidelines 
of the UN FAO/WHO Expert Committee on Food Additiv es.  He invited Brazil to clarify its reasons 
for utilizing such parameters.  
229. The representative of the United States also sought clarification as to why the proposed 
requirements for gin only permitted it to be produced by the redistillation of potable ethyl alcohol of 
agricultural origin and str essed that such a definition would block certain US exports of gin to Brazil.  
Also, why did the proposed requirement for rum incl ude rum produced from sugar beets?  It was also 
his delegation's understanding that Brazil intended to drop its regulatory references to Bourbon and 
Tennessee Whisky and add a provision that these products  were distinctive of the United States.  He 
requested confirmation of this intention and encour aged such an action.  Finally, like the European 
Communities, his delegation's understanding was th at the proposed measures would not apply to 
imports and Brazil was requested to clarify this, as well as to take oral and written comments into 
account.  
230. The representative of Brazil  noted that the proposed regulations were the only update to 
existing regulations adopted in 1973.  The process of updating had been conducted in a transparent 
manner: public consultatio ns had been held and additional tim e for comments had been granted to 
interested parties.  He pointed out that all comme nts received would be analysed before the final 
regulations would be published.  With respect to the analytical parameters, Brazil's proposed 
regulations defined categories of spirits in terms of raw materials, production processes and analytical 
parameters for chemical components.  Analytic al parameters for chemical components were 
considered as an important instrument to attest the quality of spirits, including to verify the correct use 
of raw materials, thereby preventi ng fraud in the production processes.  G/TBT/M/46 
 Page 45 
 
 
  231. The representative of Brazil further noted th at the proposed regulations reproduced the 
minimum and maximum levels of alcohol already co ntained in other national legislation (Decree 2314 
of 1997), and Mercosur rules.  However, Decree 2314, in its Article 34, ma intained that beverages 
which were produced abroad and did not comply with Brazilian standards could be imported, 
provided that a certificate was presented attesting that: the beverage was a typical product from its 
country of origin; that it was produced in accordance with its country’s laws and regulations; and it 
was regularly consumed in that country.  He str essed that Brazil’s proposed regulations would not 
restrict the importation of beverages regularly produ ced and consumed abroad.  Finally, he noted that 
bilateral meetings at the technical level were ongoing  with Mexico to discuss recognition of tequila as 
Mexican geographical indication.  His delegation would also be willing to engage in similar talks with 
the United States regarding Bourbon and Tennessee whisky. 
(ix) China – Proposed Regulations on Information Security (G/TBT/N/CHN/278-290) 
232. The representative of the European Communities  reiterated his delegation's concerns with 
respect to the proposed regulations that would mandate compulsory certification of various 
information technology products in relation to inform ation security requirements.  He invited China to 
clarify whether a decision had been taken to postp one the publication and entry into force of the 
proposed regulations pending bilateral discussions bot h at government and at experts level with the 
WTO Members which had raised concerns at previous  meetings.  He noted that, according to previous 
announcements, the proposed entry into force fo r the new requirements was 1 May 2009.  A 
confirmation that this date was no l onger the target date for entry into  force was particularly important 
and would provide legal certainty.   
233. The representative of the European Communities not ed that China had stated that the goal of 
the proposed regulation was the protection of nationa l security.  However, his delegation believed that 
adopting any technical regulation mandating tes ting and certification for products intended for 
commercial or consumer use would be inconsiste nt with the stated goal of national security.  
Moreover, the proposed regulations would be unprecedented and unique in view of their wide scope, 
the depth of the conformity assessment envisaged  and the corresponding detailed information that 
would be required of companies.  He encouraged  China to pursue dialogue with other WTO Members 
and stakeholders with a view to exchanging expe riences on current government and business practices 
with regard to information security, as several economies faced similar problems in this field. 
234. It was further stressed that technology in the fi eld of information security progressed at a very 
fast pace and that limiting the choice of applicable technical specifications to a single set of standard 
requirements would stifle innovation and foreclo se the introduction of new and more advanced 
technologies in China.  Also, the certification pro cess that was envisaged in the proposed regulations 
would be very long according to the best estimate ba sed on current industry practices, and as a result 
the latest technologies could not be deployed in  the Chinese market.  Therefore, there were doubts 
about whether the proposed regulatory approach woul d be effective to achieve the goal of improving 
the level of national information security protecti on.  It was also noted that information that 
companies would have to disclose under the proposed  regulations was sensitive intellectual property 
protected information, which related to the core of  the IPR portfolio of IT companies.  Therefore, 
companies would not be in a position to provide to foreign conformity assessment bodies information 
that was vital for their business.  In this regard  China's attention was drawn to the provisions in 
Article 5.2.4 of the TBT Agreement on the protecti on of legitimate commercial interests in the 
framework of conformity assessment procedures. 
235. The representative of Japan  shared the concerns raised by the European Communities and 
stressed that the regulations could have a significan t impact on trade of other Members.  He pointed 
out that, in accordance with Article 2.5 of the TB T Agreement, China should explain the justification 
for these measures in terms of the provisions containe d in Articles 2.2 to 2.4 of the TBT Agreement.  G/TBT/M/46 
Page 46  
 
  He added that there was also concern from the vi ewpoint of the protection of technical information 
and IPRs, especially because of the characteristic of the products at issue. He invited China to explain 
the rationale and the purpose of the measures.  He agreed with the European  Communities that other 
countries had similar concerns and s ought updated information, in par ticular on the timetable for entry 
into force of these regulations. 
236. The representative of Korea
 shared the views expressed by  the European Communities and 
Japan.  He noted that Korean industry was conc erned about the scope of the measure and the 
likelihood of information leakage once the regulati on was adopted.  He requested China to postpone 
the adoption of the regulation and to reinforce bi lateral discussions both at a technical and at a 
political level. 
237. The representative of the United States  stated that his delegation continued to have strong 
concerns about the 13 proposed technical regulati ons related to information security, notified by 
China in August 2007.  As previously stated, these regulations went s ubstantially beyond global 
norms by mandating testing and certification of in formation security in commercial information 
technology products.  In other countries, mandatory testing and certification for information security 
was only required for products used in sensitive go vernment and national security applications.  He 
wondered whether China had analyzed the practices followed in other countries with regard to the 
regulation of information security in the commercial  sector and, if so, whether could China explain 
the results of its analysis.  
238. Despite the concerns, the United States appr eciated the willingness of officials from the 
Certification and Accreditation Administration of th e People's Republic of China (CNCA) and China's 
Ministry of Commerce to maintain an open line  of communication with government officials and 
industry groups from the United States and other countries on this issue.  The United States also welcomed the commitment that China's Vice Prem ier had made in September 2008 that China would 
delay the publication of final technical regulations  while Chinese and foreign experts continued to 
discuss possible approaches to the re gulation of information security.  
239. It was further noted that China had previously indicated that compliance with the 13 proposed 
technical regulations would become mandatory on 1 May 2009. Subsequently, CNCA officials had 
indicated that they had envisioned a one-year tran sition period between the eventual publication date 
of the 13 technical regulations in final form and the date by which compliance would become 
mandatory.  China was invited to clarify whether it would delay its planned 1 May 2009 certification 
requirement for the covered products.  China was urged to refrain from adopting any measures that 
mandated information security testing and certificat ion for commercial products and to clarify the 
status of the 13 proposed technical regulations and Ch ina's future plans.  This  had also been indicated 
in the submission from the United States for th e Transitional Review Mechanism (G/TBT/W/292). 
240. The representative of China
 explained that the objective of the proposed information security 
products compulsory certification scheme was in co mpliance with the legitimate objectives stipulated 
by the TBT Agreement.  He pointed out that many  countries had established certification schemes for 
information security products and that China had b een open and transparent in developing the draft by 
notifying the proposed regulation and soliciting co mments from stakeholders, both domestically and 
abroad.  He also noted that fruitful bilateral discussi ons had been held with in terested trading partners, 
including the European Communities, Japan and th e United States and that China was committed to 
continue to be transparent to en sure that the final regulations would be science-based and reasonable. 
241. The representative of China further stressed that  his delegation attached great importance to 
other trading partners' concerns on the proposed regula tions.  This is why the regulations had not been 
adopted on 1 May 2008 as originally scheduled – to leave more time for further technical 
communication and discussion among regulators and expe rts both at national and international level.   G/TBT/M/46 
 Page 47 
 
 
  His delegation was aware that a period of transition was needed and therefore a reasonable time 
would be provided for adaptation.  With respect to standards in the proposed certification scheme, he 
stressed that China had complied with the TBT Agreement by taking ISO IEC 15408 "Guidelines for information technology safety evaluation" as the foundation for the standards involved.  More 
specifically, the common criteria requirements on the products functions and safety assurance had 
been adopted.  The scheme would be applied e qually for both domestic and imported products. 
(x) China – Wines (G/TBT/N/CHN/197) 
242. The representative of the European Communities
 reiterated her delegation's concerns about 
the above-mentioned notified measure, in particular with respect to the maximum levels of sulphur 
dioxide in wines.  She pointed out that these limits were more restrictive than the maximum levels set 
by the International Organization of Wine and Vi ne (OIV) and constituted an unnecessary obstacle to 
trade according to Article 2.2 of the TBT Agreemen t.  The European Communities had been informed 
by the Chinese authorities that the wine standard concerned was being reviewed and that relevant 
international standards would be taken into account in the revision process.  She sought an update of 
this revision and invited China to indicate when  these new measures would be notified to the TBT 
Committee. 
243. The representative of China  confirmed that the standard on wine was being revised and that a 
notification would soon be made.  Comments by th e European Communities on the new draft would 
be welcome. 
(xi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
244. The representative of the European Communities  reverted to a previously raised concern 
about India's Order laying down a registration pro cedure for imported cosmetics products, which had 
been adopted before being notified.  She pointed out that comments had been sent on 22 July 2008, in which it had been highlighted that this measure wo uld introduce long delays before products could be 
placed on the market, would be unreasonable costly , would discriminate against imported products 
and would require the disclosure of confidential business information.  The requirements seemed 
unnecessary and unjustified to attain the stated objective of increasing product safety for consumers 
and of curtailing counterfeiting and parallel trade.  Her delegation was also of the opinion that the 
Order was in certain aspects vague, and could lead to  problems in interpretation and enforcement.  As 
no reply to the comments made ha d been received, the representativ e of the European Communities 
invited India to provide a written reply, as well as an update of the state of play.  
245. The representative of the United States
 reiterated his delegation's concerns on India's "Drugs 
and Cosmetics (Amendment) Rules of 2007" which amended the Drug and Cosmetics Rules of 1945.  
His delegation's understanding was that this amen dment would introduce a new registration system 
for cosmetics products that US industry believed to be overly bu rdensome and unreasonably costly, 
and that it would cause unnecessary delays to market for companies' products.  
246. The representative of the United States sought confirmation from Indian authorities about 
whether an equivalent measure existed for dome stic products or not.  His delegation was also 
interested in gaining a better understanding of ho w India foresaw this measure would increase product 
safety. In particular, what type of analysis had been done before determining to apply these measures 
to all imported cosmetics? Furt her, given that cosmetics producers already had to obtain a non-
objection certificate from the Ministry of Health, could India explain what value was added by the additional registration requirement?  
247. It was also noted that there did not appear  to be any publicly available information 
concerning: what testing laboratories were, or w ould be, certified for the examination, testing and G/TBT/M/46 
Page 48  
 
  analysis of cosmetics; the criteria or procedures by which India would accredit labs; or the procedures 
that labs had to follow in order to participate in th e registration system.  Did India plan to publish such 
information?  Given the outstanding concerns, Indi a was urged not to mandate compliance with the 
amended rules until these issues were addressed. 
248. The representative of India
 explained that the proposal for amendment in the Drugs and 
Cosmetics Rules had been considered by the Drugs Consultative Committee, following 
recommendations by the State Licensing Authority th at there was a need to regulate the import of 
cosmetics and cosmetic products in order to assure their quality and safety.  Based on these recommendations, the Government of India had approved the proposed draft rules. 
249. The purpose of the amendment was to streamline import of cosmetic products into India with 
the objective of ensuring public health and safety.   The registration process would ensure that 
cosmetics coming into India were pre-examined.  Th is would also reduce complications at customs to 
verify cosmetics after imports.  It was noted th at cosmetic products manufactured in different 
countries followed different regulations.  While  some countries followed rigorous systems of 
regulatory control to ensure that cosmetics manufactured for sale in those countries conformed to 
safety norms, such norms were not uniformly employed by all countries. 
250. It was also noted that certain chemicals wh ich were prohibited in benchmark countries 
continued to be used in several other countries.  It was therefore necessary to regulate the import of 
cosmetics into India to ensure that these did not  contain harmful ingredients and conformed to the 
standards prescribed for them.  Clarification a nd additional information would be provided to 
interested Members, including the Unite d States and the European Communities. 
(xii) India - Pneumatic Tyres and Tubes for Automotive Vehicles (G/TBT/N/IND/11 and 20) 
251. The representative of the European Communities
 recalled that at the last Committee meeting 
her delegation had stated that there were still conc erns with regards to the requirements for tyre 
manufacturers.  In the reply to these concerns, the Indian delegate had said that the comments would 
be transmitted to capital and responses would be gi ven at the next TBT Committee meeting.  She 
invited India to provide replies to the questions raised  before and in particular: (i) if the notified draft 
was already adopted and, if so, when it would enter into force; (ii) if the license fee for tyres was 
calculated in a different way for tyres produced in In dia and for imported tyres; (iii) if tyres could be 
certified in other laboratories than the only accredited laboratory in India (Central Institute for Road 
transport); (iv) if tyres complying with UN-ECE Regulations would be recognized.  
252. The representative of the United States  sought a better understanding of the objectives and 
requirements of the Bureau of Indian Standards (B IS) protocol on conformity assessment procedures 
for tyres, so as to allay industry's concerns that imported tyres could be treated less favourably than 
domestic tyres.  Of particular concern was the fact that differential fee calculation methodologies 
applied to domestic and imported tyres might discr iminate against imported tyres.  Industry had 
estimated that the conformity assess ment fee for domestic tyres was 0,5 cents per tyre whereas the fee 
for imported tyres was 34 cents per tyre.  He noted that India had denied that the conformity 
assessment fees were higher for imported tyres and sought information from India about how industry 
calculations were incorrect and if India could prov ide its own calculations s upporting its position that 
the fees were the same.   
253. Additionally, the representative of the United St ates recalled that a draft amendment had been 
proposed to the Central Motor Vehicles Rules on 6 May 2008.  The draft, which included a provision 
that appeared to govern conformity assessment proce dures for tyres, also appeared to require that 
tyres meet the applicable requirements as of 1 May 2 008, five days prior to the publication of the draft 
amendment.  His delegation was awaiting clarification from India as to how the draft amendment  G/TBT/M/46 
 Page 49 
 
 
  related to the BIS tyre protocol, whether comp liance was required as of  1 May 2008 and whether 
India intended to notify the draft amendment to the WTO.  Given that compliance with the BIS 
protocol would be mandatory once implemented, an d in light of the outstanding concerns, he urged 
India not to require industry compliance with the protocol until these issues were addressed.   
254. The representative of Japan  shared the concerns expressed.  In his delegation's view, the 
regulation caused unfair and excessive testing and certification costs as well as time constraints for 
foreign-based firms.  Furthermore, testing and cer tification capacity within India was insufficient to 
meet the needs.  Japan also believed that there n eeded to be a longer implementation period: two years 
might be necessary in order to allow trading firms to get such certifications. 
255. The representative of India  recalled that the proposed manda tory requirements for standards 
with respect to imported tyres had been made to ensure quality and safety and that the same 
requirements were equally applicable to the dom estic producers.  The Government of India had 
proposed to bring pneumatic tyres and tubes for au tomatic vehicles under mandatory BIS certification 
as per the following Indian standards: 15627, 1563 3, 15636, 13098.  He stressed that the proposed 
mandatory certification was in public interest an d was not intended to treat imported tyres less 
favourably than domestic tyres as the same requireme nts would also be applicable to Indian tyre 
manufacturers.  In response to th e European Communities and the United States, he clarified that the 
measure had not yet been adopted. 
256. With respect to the implementation period, the representative of India noted that the 
notification was circulated in July 2006, giving 60  days for comments.  He considered that over two 
years of implementation period, after the expiry of  the comment period, had already been given and 
that by no means this period could be considered in adequate.  With respect to the questions raised by 
the European Communities and the United States on the license fee structure and by Japan on the 
testing facilities in India, they would be referred b ack to capital and a reply provided in due course.  
(xiii) Norway – Hazardous substances (G/TBT/N/NOR/17) 
257. Following concerns raised by Members at previous meetings of the Committee, the 
representative of Norway  confirmed that Norway intended to in troduce measures to restrict the use of 
some hazardous chemicals in consumer products.  The justification for the proposed regulation was 
the risk of adverse affects to health and environment from hazar dous properties of these chemicals 
combined with their use in consumer products.  She recalled that the proposed regulation had been 
subject to an extensive hearing process at the na tional and international level.  This process had 
triggered several comments on the proposal from WTO Members, EU industry and other 
stakeholders.   
258. As a follow-up, a second review of the propo sed regulation was conducted.  An expert from 
the Norwegian Pollution Control Authority informed  the Committee that as a result of the second 
review, eight substances had  been removed from the list of the regulation:  musk ketone, tens ides, 
phthalate DEHP, tinorganic compounds and the br ominated flame retardant TBBPA.  Other 
modifications were being considered for the remain ing ten substances, such as limit values or further 
exemptions.  She noted that WTO Members had made comments on about six of these substances. 
259. In particular, on arsenic and arsenic compounds , the representative of Norway explained that 
the draft regulation was based on the classification in the European Commun ities in accordance with 
Directive 67/548/EEC, as well as on monitoring data from Norway documenting widespread occurrence of arsenic in the environment.  Arsenic  and arsenic compounds were not degradable and  
could be acute and chronically toxic for many organi sms, even in small concentrations.  They were 
very toxic for aquatic organisms, and could cause adverse long-term effects in the aquatic G/TBT/M/46 
Page 50  
 
  environment.  In Annex 1 of the Directive 67/ 548/EEC there were group entries for all arsenic 
compounds classified as carcinogenic.  
260. It was noted that, according to Norwegian monito ring reports, arsenic contamination had been 
found in the air, reindeer, sediments and soil contamination.  Arsenic was used in semiconductor 
production and there were indications that electronics comprised the greatest remaining source in 
products.  The European Chemicals Agency Member State Committee had agreed on the 
identification of 4 arsenic substa nces as Substances of Very Hi gh Concern (SVHC) that could be 
subject to authorisation in the context of REACH.   ECHA had also added the 4 arsenic substances to 
the "Candidate List" of Substances of Very Hi gh Concern for authorisation published in a press 
release from ECHA of 28 October 2008.  It was further pointed out that, in the Norwegian draft 
regulation, arsenic and arsenic compounds were propo sed to be regulated when the content of the 
substance in the product's homogeneous individual pa rts was greater than or equal to 0.01 percent by 
weight for consumer products in general with  some exemptions and individual limits.  
261. With respect to Bisphenol A, the representative of Norway explained that the hazards of this 
substance were evidenced by a number of studies sh owing neurotoxic effects at low level exposure, 
by the classification in the European Commun ities according to Directive 67/548/EEC, by the 
concerns for endocrine disrupting effects in aquatic  organisms documented in the EC risk assessment 
in the framework of Regulation No 793/93/EEC, as well as by the comprehensive monitoring data 
from the environment in Norway.  Bisphenol A was classified as toxic for reproduction with the risk 
phrase "possible risk of impaired fertility", and was cl assified with the risk phrase "harmful to aquatic 
organisms". 
262. The representative of Norway further pointed ou t that laboratory studies had shown that low 
level exposure to Bisphenol A dur ing development could cause neurotoxic effects, in particular 
changes in brain and behaviour.  The EC risk assess ment for health concluded that there was no risk 
to humans exposed via the environment.  Howe ver, studies showing neurotoxic effects at low 
exposure levels had not been take n into account.  Norway, Sweden and Denmark had concluded that 
the studies showing neurotoxic effects at low leve l exposure could not be ignored.   The National 
Toxicology Program Centre for the Evaluation of  Risks to Human Reproduction Expert Panel had 
also concluded that there continued to be concer ns connected with possible neurotoxic effects of 
Bisphenol A and that further tests ought to be carri ed out.  This was supported in a recently published 
monograph from National Toxicology Program and was in line with the assessment of Norway.  
263. It was also highlighted that the EC risk assessment for environment reported that Bisphenol A 
had endocrine-disrupting effects in fish.  Moreove r, there continued to be a concern for possible 
affects on snails at even lower concentrations than  the predicted no effect concentration for aquatic 
organisms that was used in the risk characterisation.   Further work in order to clarify this was being 
conducted by the UK Government.  The risk assessmen t would be re-evaluated in the context of 
REACH when the final results of the testing would be made available.  Monitoring data showed a 
substantial spreading of Bisphenol A in the envir onment in Norway, such as freshwater and fish along 
the Norwegian coast and sediments in the Barents Sea.  The Norwegian Pollution Control Authority 
had undertaken a study which showed that individua l consumer products were identified with some 
very high quantities of free (residual) Bisphenol A.  
264. The representative of Norway stressed that in the estimates of children's combined exposure 
for Bisphenol A from consumer produc ts, food and the environment, the margin of safety based on 
the no adverse effect level (NOAEL) carried out by the European Food Safety Authority was too low. 
The NOAEL concluded by EFSA  had not taken in to account the studies reporting neurotoxic effects 
at low exposure levels.  She pointed out that the Canadian authorities had published the final 
screening assessment report and proposed risk manage ment approach of Bisphenol A in October 2008 
and that regulations were expected to come into  effect in 2009.  This supported the Norwegian  G/TBT/M/46 
 Page 51 
 
 
  proposal.  Additionally, she noted that the draft regulation only set a limit for the content of residual 
monomers.  It was proposed to regulate free Bis phenol A when the content of residual (free) 
Bisphenol A in the product's homogeneous individua l parts was greater than or equal 0.005 per cent 
by weight.  Some exemptions were also suggested. 
265. As for cadmium and cadmium compounds, the representative of Norway explained that the 
proposals were based on the classification in EC Directive 67/548/EEC as well as on monitoring data 
from Norway which documented widespread o ccurrence of both cadmium and lead in the 
environment.  Cadmium was acutely and chronically toxic to humans and animals even in very small concentrations.  Cadmium was very toxic for aquatic organisms, particularly in freshwater and acutely 
toxic for mammals.  Most cadmium compounds were  carcinogenic and cadmium bioaccumulated in 
fish and mammals and had a long biological half- life in mammals.  Accord ing to the Norwegian 
monitoring, cadmium had been shown in vegetation, surface soil and animals, fjords and watercourses.  
266. It was further stressed that the EC Risk A ssessment Report (RAR) had concluded that, for 
both cadmium and cadmium oxide, there were scenar ios that needed specific measures to limit the 
risk for humans exposed via the environment.  Mo reover, it was recognised that cadmium toxicity in 
water was dependent on water hardness  (mg CaC03/L).  In Norway, ther e were many very soft waters 
(hardness < 40 mg CaC03/L) and a cadmium exposure in Nordic waters would therefore have a higher possibility to cause negative environmental effects than in waters with higher hardness.  
Cadmium and cadmium compounds would be regulate d when the content of the substance in the 
product's homogeneous individual parts was greater than or equal to 0.01 per cent by weight.  Also in 
this case, some exemptions were proposed. 
267. Turning to lead and lead compounds, the represen tative of Norway pointed out that lead was 
not degradable and was toxic in low concentrati ons, having both acute and chronic health and 
environmental effects.  Lead was acutely toxic to  humans and chronic lead poisoning could have 
neurotoxic and immunological effects.  Lead was also harmful to reproduction and could result in 
brain injuries.  Children were more exposed than a dults.  The lead compounds were also very toxic for 
aquatic organisms, and could cause long-term adverse effects in the aquatic environment.  According 
to the Norwegian monitoring, lead had been shown in humus layers, sediments in lakes and fjords, 
soil and organisms.  
268. It was also noted that Denmark had a national regulation in force on the use of lead and lead 
compounds for selected application areas.  The Norw egian proposal was to a great extent based on the 
Danish regulation in force and proposed to regulat e lead and lead compounds when the content of 
lead compounds in the product's homogeneous individua l parts was greater than or equal to 0.01 per 
cent by weight.  The proposed regulation on meta llic lead only applied for specified areas.  In 
particular, some exemptions were provided for both metallic lead and lead compounds. 
269. With regards to Hexabromocyclododecane (HBC DD), the representative of Norway pointed 
out that the risk assessment was based on compre hensive work done in the EC risk assessment 
(framework of Regulation 793/93/E EC ) and proposal for classification according to Directive 
67/548/EEC.  HBCDD was considered as extremely t oxic to aquatic organisms.  Moreover, it was 
persistent and could cause long-term adverse effects on the environment.  In the EC working group on 
classification and labelling of dange rous substances, no resolutions  had been adopted concerning 
health classification of HBCDD.  However, a propo sal did exist concerning classification with the risk 
phrase "may cause harm to breast-fed babies".  She high lighted that, in June 2003, it had been agreed 
that the substance should be classified as dangero us to the environment and that lower specific 
concentration limits would be set to 0.025 per cent.    G/TBT/M/46 
Page 52  
 
  270. It was stressed that HBCDD had been found in  remote areas, far from potential sources:  in 
fish from Northern Norway and Spitsbergen, in Po lar bears from Greenland and Spitsbergen and also 
in animals high in the food chain.  These findings  suggested that HBCDD was transported long-range 
via the atmosphere, and this was supported by recen t studies.  Since the highest concentration had 
been measured in marine mammals, this indicated that HBCDD was biomagnified.  More recent data 
indicated that the levels in marine mammals we re increasing.  The European Chemicals Agency 
Member State Committee had also agreed that HBC DD was a PBT substance, which meant that it was 
accumulating and toxic.  It identified HBCDD as a Substance of Very High Concern (SVHC) that 
may become subject to Authorisation in the cont ext of the REACH Regulation.  ECHA had added 
HBCDD to the "Candidate List" of Substances of Very High Concern for Authorisation.  In the draft 
regulation, HBCDD was proposed to be regulated in  consumer products with a limit value of 0.1 per 
cent by weight. 
271. Finally, concerning Perfluorooctanic acid (PF OA), the representative of Norway explained 
that the draft regulation was based on the classification in Directive 67/548/EEC as well as on monitoring data documenting widespread occurrence of  PFOA in the environment.  For example, in 
studies on mammals, the substances were shown to be chronically toxic and harmful to reproduction. 
PFOA was also suspected of being carcinogenic and studies had shown that PFOA was toxic for 
aquatic organisms.  PFOA was classified as canci nogenic Category 3 and harmful to Reproduction 
Category 2. 
272. It was also noted that several studies had shown that PFOA did not degrade in the 
environment. PFOA had been found everywhere in  the environment and PFOS and PFOA had been 
shown as the most common perfluorinated compounds  in sediments from Spitsbergen, a location 
where there had been no human activity for 40 year s, which demonstrated that the substance was 
transported in the air.  Monitoring data confirmed that the substances had been widely spread in the 
environment in the Nordic countries, including Norw ay.  The substances had been found in relatively 
high levels in human blood and in animals, including in the Arctic.  A new Norwegian study of 
human blood samples from Northern Norway and Sibe ria showed PFOS and PFOA in all the samples.  
The draft regulation included PFOA in consumer products with a limit value of 0.005 per cent by 
weight (for the products homogenous individual parts) .  Exemptions and individual cut off values for 
textiles and coated products were under considerati on.  Finally, the representative of Norway noted 
that additional substances, medium chain chlori nated parafins, musk saline, pentaclorofino and 
triklosane had also been included in the proposal and that fact sheets on all ten substances were 
available on request.  
273. The representative of Jordan
 appreciated the update from Norway.  With respect to the 
substances of interest to his delegation, TBBA and HCBBD, he was pleased that TBBA was exempted from the scope of the regulation.  His delegation would seek bilate ral consultations with 
Norway with respect to HCBBD, for which many ot her Members had also called for an exemption. 
274. The representative of the United States
 appreciated the detailed report from Norway, and 
noted that it would be shared with experts in capital. 
(xiv) Sweden – Restrictions on the use of  Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/SWE/59) and European Communities – Directive 2002/95/EC on the Restriction of 
the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) (G/TBT/Notif.00/310, Corr.1) 
275. The representative of Israel
 recalled that deca-BDE had been exempted from the RoHS 
Directive following a risk assessment which had concluded that deca-BDE did not represent any significant risk to health or environment.  Howeve r, on April 2008, the European Court of Justice had 
ruled that the exemption given for deca-BDE should be annulled by 1 July 2008, based on procedural  G/TBT/M/46 
 Page 53 
 
 
  flaws in the exemption process.  As a result, deca- BDE was not be exempted from the ban within the 
RoHs Directive, and as of 1 July 2008 was restrict ed from use in electronic and electrical equipment. 
She noted that the RoHS Directive was being re viewed and urged the European Communties to 
exclude decaBDE from its scope, thus amendi ng the unjustified distortion to trade.  
276. The representative of Israel further reca lled that, on 26 May 2004, the European Union 
competent authorities had closed, after 10 years of  research, the scientific assessment of commercial 
deca-BDE.  The assessment had concluded that ther e was no significant risk for the environment or 
human health and that therefore there was no scientif ic justification for the inclusion of deca-BDE in 
the RoHS Directive.  Her delegation considered  this restriction as an unnecessary obstacle to 
international trade, within the meaning of Article  2.2 of the TBT Agreement and urged the European 
Communties to follow its own scientific results and exclude deca-BDE from the RoHS Directive 
scope in the current review. 
277. The representative of Jordan  shared the concerns expressed by Israel.  He pointed out that the 
EC risk assessment had concluded that was no signifi cant environmental or health risks posed by the 
use of deca-BDE. On that basis, deca-BDE had b een excluded from RoHS Dir ective.  However, the 
Court decision of April 2008 had ruled out the ex emption of deca-BDE from the scope of the 
Directive.  His delegation considered this as an unnecessary obstacle to international trade and 
therefore not in compliance with Article 2.2 of  the TBT Agreement.  He urged the European 
Communities to exclude deca-BDE from the scope of the Directive as there was no scientific 
justification.  He sought an update from the European communities on this matter. 
278. The representative of the European Communities  explained that the Communities were bound 
to respect decisions the European Court of Justice and confirmed that, due to procedural flaws, the 
exemptions covered in the RoHS Directive had to be withdrawn.  The European Communities were in 
the process of revising and recasting the Directiv e and deca-BDE was among the issues which were 
currently being examined in the context of the revi sion.  She informed the Committee that an impact 
assessment on the revision of the RoHS Directiv e had been completed and a proposal was being 
finalized on the basis of that impact assessment.  Both the proposal and the impact assessment would 
be published in early December.  The revised propos al would be notified to the TBT Committee at the 
draft stage and sufficient time would be provided to submit comments. 
279. The representative of the United States  noted that his delegation continued to monitor closely 
the ongoing recast of the RoHS Directive concerni ng restrictions on hazardous substances.  Concerns 
remained about the potential magnitude of the cost of compliance - in particular for small and medium 
sized enterprises - that could result from an expansio n of the Directive.  He emphasized the need for 
EC regulators to ensure a risk and science-base d approach to the RoHS review, including in 
evaluating whether to add substances to the list,  set maximum concentration levels for specific 
products, or grant exemptions.  
280. The representative of the United States furthe r encouraged the European Communities to 
provide clarity in a timely manner on how RoHS and REACH would fit together.  There was the 
potential that this could be a problem as there were several substances that were slated for priority 
assessment under the draft RoHS recast which were also listed on the authorization candidate list for REACH.  Could the EC clarify which measure gove rned in such a situation?  Was the RoHS 
Directive going to be phased out in order to ensure  that similar conflicts would not develop in the 
future?  He pointed out that such potential overl ap highlighted the importance of receiving published 
legal guidance from the European Communities as to  the significance of a substance being placed on 
the REACH authorization candidate list, and that  it would be premature to substitute for any 
substances until analysis of particul ar end-uses had been completed.  G/TBT/M/46 
Page 54  
 
  281. In concluding, the representative of the Un ited States stressed that, as the European 
Communities proceeded with its review of the Di rective, a transparent process should be conducted 
that allowed meaningful opportunity for comment by all interested stakeholders.  The European Communities was also requested to provide a reas onable period of time for suppliers to implement 
any changes made to the Directive, as this  had not necessarily occurred in the past. 
282. The representative of Japan
 shared the concerns expressed by the United States and sought an 
update on the scenario being considered by European Communities which would minimize the 
negative impact on trade. 
283. The representative of th e European Communities  referred to the comments made earlier about 
the finalization of the impact assessment.  She str essed that one of the objectives was to clarify links 
between the RoHS Directive and other EC legisl ation, including REACH and the Marketing and Use 
Directive.  
(xv) Brazil – Registration Requirements for Medical Devices 
284. The representative of the United States  reiterated his delegation' s concerns about Brazil's 
Resolution 185 on ANVISA's registration and re-regi stration requirements for medical devices.  The 
United States were concerned that ANVISA's require ment to submit certain economic data with each 
registration did not appear to be related to th e safety and efficacy of medical devices, and was 
unnecessarily costly and burdensome.  US industry had indicated that some of the information 
required by ANVISA was impossible to provide, either because that information did not exist, or existed but was sensitive commercial information or could only be provided by calling other 
companies to obtain it, which raised potential antitrust issues.  
285. The representative of the United States furthe r noted that ANVISA had already denied 
commercialization in certain instances due to a failu re to provide economic data.  The requirement 
also created substantial uncertainty for medical  device companies that operated in the Brazilian 
market, because ANVISA did not let suppliers k now whether the economic data that they had 
submitted was sufficient.  This meant that ANVISA  could potentially issue a denial at any time, 
blocking trade in that product and forcing indust ry into a situation of constant uncertainty.  
286. It was also pointed out that industry continued to try to engage Brazilian authorities so that 
these information requirements were implemented in  a clear, transparent, and predictable manner to 
avoid creating unnecessary disruptions of trade in me dical devices.  However, ANVISA had thus far 
failed to address in a meaningful way the construc tive and detailed industry proposals to ameliorate 
the situation, and had not modified Resolution 185 in any way.  Finally, the representative of the 
United States stressed that Resolution 185 posed a real barrier to open and fair market access for 
medical devices, and should be eith er amended or withdrawn.  He  urged Brazil to devote positive, 
high level attention to this issue as the only way of resolving it. 
287. The representative of the European Communities
 recalled that her delegation had raised 
concerns about this measure at previous meetings of the Committee.  She invited Brazil to take into 
account the comments made and to reinforce disc ussions with economic operators, which were 
currently encountering problems.   
288. The representative of Brazil  reaffirmed his delegation's pos ition that Resolution 185 was not a 
technical regulation nor a conformity assessment pro cedure, and therefore it was not covered by the 
TBT Agreement.  His delegation was open to discuss the issue bilaterally with interested delegations.  G/TBT/M/46 
 Page 55 
 
 
  (xvi) Germany – Ban on Seal Produc ts (G/TBT/N/DEU/5 and Add.1) 
289. The representative of Norway  reiterated concerns on the banning of imports of seal products 
by several EC member States, the most recent of which had been notified by Germany.  Her 
delegation believed that the ban on seal products was not an animal welfare issue, it was not a 
conservation issue and it was not a management issu e.  Rather, it was a public opinion issue which 
was considered as unsubstantiated a nd unjustified.  Banning the imports of seals in member States of 
the European Communities set a dangerous precedent fo r trade in animal products that were harvested 
in a sustainable and humane manner.   
290. It was Norway's expectation that the Europ ean Communities would notify any draft on future 
regulations concerning trade in seal products to th e TBT Committee within the times limit of the TBT 
Agreement.  It was noted that the European Commission had not notified its proposed regulation 
concerning trade in seal products to the TBT Committ ee, whereas the in-part restrictions of certain 
individual EC member States had been notified.  The European Communities w as requested to clarify 
their plans with respect to the notification to the TBT Committee or other WTO bodies and how they 
would ensure that WTO Members' views would be taken into account.  Norway continued to reserve 
its right to take any appropriate action necessary to defend its interests under the TBT Agreement and 
other relevant WTO agreements. 
291. The representative of Canada  fully supported Norway's views. 
292. The representative of the European Communities  pointed out that, as had been noted in 
previous meetings of the Committee, the draf t proposal had been notified to the European 
Commission under internal procedures and discussions  with the German authorities were underway.  
She took note of the comments made by Norway with respect to the EC notification. 
(xvii)  Canada – Compositional Requirements for Cheese (G/TBT/N/CAN/203) 
293. The representative of the United States  recalled that his delegation had raised concerns in 
previous meetings of the Committee regarding the market access impact and potential cost burden of 
Canada's new compositional requirements for cheese.  As these issues were of  great concern to US 
industry, his delegation would cont inue to review developments - including the new litigation in 
Canadian domestic court, a nd would be monitoring the measure's impact on trade flows. 
294. The most immediate concern of the US delega tion was that Canada would require compliance 
with the compositional requirements on 14 Decembe r 2008.  The United States and other Members 
had raised this issue at the previous meeting of  the Committee and Canada had indicated that an 
“import-licensing scheme” would be published later in the summer.  However, thus far the United 
States had not seen any such publication.  A copy of the general implementa tion approach had been 
received by the United States, but there seemed to be  additional details to follow and there were less 
than six weeks to go before the requirements became mandatory.  
295. The representative of the United States furthe r stressed that the TBT Agreement required 
Members to provide a reasonable interval between the publication of conformity assessment 
requirements and their entry into force.  He urge d Canada to consider de laying enforcement of the 
measure beyond 14 December, until the complete impl ementation approach had been put in place 
following a process of stakeholder review and comment. 
296. The representative of New Zealand  echoed the US views.  His delegation had also raised 
concerns at previous meetings, in particular about the restrictive nature of the regulations.  He noted 
that his delegation had engaged bilaterally with Canada to e xpress concerns, and acknowledged the 
information on the implementation approach.  Howe ver, like the United States, his delegation was G/TBT/M/46 
Page 56  
 
  concerned that there were only six weeks before th e measure was to be implemented, and a lack of 
clarity remained.  He was also concerned that the regulations deviated substantially from the Codex Alimentarius' standards for cheese and was unclear about what was Canada's legitimate objective in 
pursuing these standards.  
297. The representative of Switzerland
 recalled that her delegation had raised concerns on this 
issue at previous meetings of the Committee. The new requirements on cheese composition were of 
particular interest to Switzerland in light of the significance of cheese exports.  She stressed that it was essential for exporters to receive further rele vant information on the new regime for import 
licenses, particularly in light of the fact that th e new system would be entering into force in one 
month's time.   
298. The representative of Australia
 joined the previous speakers in expressing concern about 
Canada's compositional standards for cheese and reite rated the views expressed by her delegation at 
previous meetings.  She noted that Canada had r ecently provided additional information, which would 
be analyzed in capital, and expected the opportunity for further dialogue on this issue prior to the introduction of the new standards. 
299. The representative of the European Communities
 joined concerns expressed by other 
delegations and reiterated her delegation's view that these standa rds would have a negative impact on 
exports to Canada of certain cheeses, as well as ba sic products such as milk protein concentrates.  
Also, the new licensing requirements could create unnecessary obstacles to trade.  She noted that 
Canada had recently published measures which implemented the new requirements.  While her 
delegation welcomed this publication,  it regretted that the requirements would come into effect on 14 
December 2008.  This short deadline was not su fficient for WTO Members and exporters to get 
acquainted with the new rules and did not give Me mber sufficient time to discuss any concerns with 
the Canadian authorities  
300. The representative of the European Communities al so shared the concerns raised by other 
Members regarding the lack of information on the import licensing regime and urged Canada to delay 
the entry into force of the new compositional sta ndards while third countries and exporters examined 
the implementing measures.  She also asked that these were notified to the TBT Committee, so as to 
allow WTO Members opportunity to submit comments. 
301. The representative of Canada  noted that, on the import licensing regime, more information 
had been released on 31 October 2008 and this w ould be notified to the TBT Committee.  Her 
delegation believed that this re gime would minimize the impact  on importers and foreign cheese 
suppliers.  She explained that in Canada the f ood industry was responsible for having measures in 
place to verify that all products met the appropria te regulations and the Canadian food inspection 
agency would then assess compliance.  The licensi ng regime would continue to require the import 
declaration, whereby the importer attested that th e product met all Canadian requirements.  To obtain 
this cheese import license, importers of cheese would need to submit an application to the Canadian 
Food Inspection Agency, along with a recall programme , a list of cheeses expected to be imported and 
additional information.  She stressed that her dele gation was willing to meet with trading partners to 
discuss this further.   
302. With respect to the implementation approach, the representative of Canada pointed out that 
the new requirements applied to both imported a nd domestic cheese, as well as food imported and 
domestic that declared cheese as an ingredient .  Records for imported cheese and cheese produced for 
federally registered establishments  would be monitored and would be consistent with other consumer 
protection activities.  Instances of non-complia nce would be assessed on a case by case basis and 
actions taken would be pr oportionate to the gravity of non-compliance.    G/TBT/M/46 
 Page 57 
 
 
  303. It was further noted that there were no plans to  allow for an extension in the implementation 
date.  However, Canadian Food Inspection Agen cy inspectors would require training prior to 
implementation of the inspection.  Interested Memb ers were invited to provide more details on the 
additional information they required, so that this  could be provided as quickly as possible.  With 
respect to the concerns raised about the impact on trade, it was stressed that assertions that the new 
requirements would result in a reduction on imports  of milk ingredients, including milk protein 
concentrates remained to be substantiated.  Th e use of milk ingredients in cheese manufacturing 
varied from one cheese processor to another and ther e was no evidence that that minimum quantity of 
casein required by the regulation would serve as an e ffective constraint on the existing use of milk 
ingredients such as milk protein concentrate. 
(xviii)  Argentina – Measures affecting Market  Access for Pharmaceutical Products 
304. The representative of Colombia  recalled that his delegation ha d raised concerns on previous 
occasions about pharmaceutical products market access in Argentina, specifically with regards to the 
country classification and the application of c onformity assessment procedures as well as issues 
related to classification and application of quot as or tariffs for undertaking verification in 
manufacturing facilities located in the originating c ountry.  This issue was originally raised in 
document G/TBT/W/280 dated 29 October 2007 and re iterated at the March and July 2008 meetings 
of the TBT Committee.  The issue had also b een discussed bilaterally with the Argentinean 
authorities.  In particular, Colombia's requests had been that the country should be included in Annex 2 of the Decrees 150 of 1992 and 177 of 19 93 and that Argentina submit the country risk 
studies and criteria used for the classification of countries.  However, no information had been 
received from Argentina.  The representative of Colo mbia stressed that his delegation's concern was 
not related to problems with laboratory inspections , but rather with Annexes 1 and 2 of the above-
mentioned Decrees. 
305. The representatives of Chile
 and Paraguay  supported the statement made by Colombia. 
306. The representative of Argentina  took note of the views expressed and stated that these would 
be conveyed to the capital.  He stressed that, a lthough a solution had not yet been reached, several 
meetings had been held with Colombia with  a view to addressing the concerns expressed.  
(xix) China – Draft Standards on Lithium Batteries for Mobile Phones 
307. The representative of Japan  recalled concerns expressed by his delegation on the above-
mentioned measures and sought an update from China on the state of play.  He requested that the 
standards be limited to safety issues, since th e measures currently under consideration stipulated 
requirements related to the environment, to perform ance and were related to battery chargers as well, 
despite the characteristic of safety standards.  Al so, the representative of Japan expressed concern 
related to the protection of intellectual property, si nce the standards contained requirements about the 
kind of materials and the methods of manufacturing. He stressed that harmoni zation with international 
standards and a cooperative relationship with firms were very important.  He also asked when the 
second Working Group meeting on the lithium-i on battery safety standards would be held. 
308. The representative of the European Communities  supported Japan's statement and requested 
an update on the state of play of these standards. 
309. The representative of China  said that standards on lithium batteries were still under discussion 
and had not been finalized, and that therefore they could not be discussed in the TBT Committee.  He 
noted that some more time was needed until the drafts would be finalized as either a technical 
regulation or a voluntary recommendation.  He stressed that the process of developing standards on G/TBT/M/46 
Page 58  
 
  lithium batteries was open to all stakeholders and encouraged stakeholders to submit comments to 
relevant Chinese agencies. 
(xx) European Communities – Regulation on Certai n Wine Sector Products (G/TBT/N/EEC/15, 
Corr.1-2 and G/TBT/N/EEC/57) 
310. The representative of the United States
 noted that his delegation c ontinued to have concerns 
regarding the EC efforts to severely restrict the ability of non-EC wine to use common or descriptive 
and commercially valuable terms, on the grounds that  those terms were traditional to European wines. 
He pointed out that these were common or descriptiv e terms, many of them adjectives, used on wine 
labels all over the world.  He was concerned that the European Communities appeared to be trying to 
claim exclusive rights in such common terms, ex cept under certain limited circumstances where the 
third country regulated the terms to the satisfacti on of the European Communities.  He noted that 
some of these terms did not have a common definition across all member States.  
311. The representative of the United States further poi nted out that the EC apparent justification 
for exclusive rights in these term s was that such measures were necessary in order to prevent 
consumer deception and stressed that, despite repeat ed requests from third countries, EC officials had 
never presented any evidence of consumer confusion or deception with the current use of such terms 
by foreign wines on the EC market.  Consumer protection, if needed, could be achieved through the use of existing IPR protection, which could accomplish many of the same results. Examples were bottle shape protection, or use of a generic term in a trademark with other terms that make it 
protectable.  He urged the European Communities to consider these concerns with the current 
regulation as it published implementing regulations on traditional terms. 
312. The representative of South Africa
 recalled that the representative from the European 
Communities had clarified that the use of certain  traditional expressions was protected under EU law 
as they related to a given language and to a specific category of wine.12  Third countries could 
therefore, freely use these expressions for all the ot her remaining wines.  The European Communities 
had stated that "it was, imperative that a request was made by that third country, according to Article 
24 of Regulation 753/2002.  The application is made in terms of the regulation".  It had also been 
pointed out that South Africa had filed an application and was exporting wines to the European Communities labelled with the Spanish expression  "Vino Fino" meaning "Fine Wine", being a 
traditional expression which was protected in the Eu ropean Communities for three types of Spanish 
wines.  
313. The representative of South Africa stressed that  his delegation had remained opposed to the 
EC system of protection of traditional expressions and that South Africa had requested that it be 
added to the relevant Annex as per the requirements of EC Regul ations 753/2002 as amended by EC 
regulation 316/2004, thereby making provision for the use of the words "ruby, tawny and vintage" and other expressions by South African wine exporters to  the European Communities.  He confirmed that 
the terms "ruby, tawny and vintage" would be utili sed in conjunction with the word "Cape" on South 
African wine exports to the European Communities.  He further noted this request was made without 
prejudice to South Africa's rights and obligations with regard to the TBT Agreement, the TRIPS 
Agreement and the South Africa-European Union Wi ne Agreement, which was part of a bilateral 
agreement between South Africa and the European Communities.   
314. In concluding, the representative of South Africa stressed that his delegation's concerns were 
related to the nature, scope and applicability of th e system for protection of certain terms by the 
European Communities.  South Africa therefore sup ported the views expressed by the United States 
with respect to the restrictions on the use of tr aditional expressions on wine labels in the European 
                                                     
 
12 G/TBT/M/45, paragraph 75.  G/TBT/M/46 
 Page 59 
 
 
  Communities, as some of these expressions had been  introduced in South Africa with European 
settlements since 1652. 
315. The representative of New Zealand  reiterated his delegation's in terest in EC regulation for 
wine trade and recalled that concerns had been  expressed and comments sent to the European 
Commission in April 2008, to which a reply had been  provided.  However, additional clarification 
was needed and his delegation would follow up with the EC TBT Enquiry Point.  His delegation 
would also await the EC notification of the draf t implementing regulation and was looking forward to 
discussing them with the European Communities.  He  shared the concerns expressed by the US and 
South Africa with respect to the restrictions on the use of traditional expression on wine labels in the European Communities. 
316. The representative of Argentina
 reiterated the concerns which were set out in G/TBT/W/290 
and expressed at the previous meeting of the TBT Committee relating to the application of the EC 
Regulation 753/02 and its amendments No. 316/04 concerning the exclusive use of a series of traditional expressions by various EC member Stat es in each of their respective languages.  He 
supported the concerns voiced by the United States, New Zealand and South Africa in relation to the 
restrictions of the use of traditional expressions on wi ne labels and recalled that this had led to the 
rejection of labels bearing add itional quality terms of wine of Ar gentinean origin within the EC 
territory.  He stressed that additional quality term s were mainly adjectives and referred to particular 
production methods or quality features that were no t eligible for protection as intellectual property 
rights under the TRIPS Agreement, so that th eir use was governed by the TBT Agreement. 
317. As acknowledged by the European Commission in its own communication to the national 
TBT Enquiry Point, Argentina considered that the use of traditional expressions was inconsistent with 
Article 2 of the TBT Agreement and for that re ason it called for the immediate revision of the 
regulations to ensure consiste ncy with the TBT Agreement. 
318. The representative of Canada
 supported the comments made by previous speakers, in 
particular the US, and noted that Canada agreed that existing legislation to protect consumers from 
misleading labelling claims could accomplish many of  the same results as the current EC 753/2002 
Regulations.  Her delegation would continue to fo llow developments in this area with interest. 
319. The representative of Mexico  associated his delegation with the comments made by previous 
speakers and recalled that his delegation had raised concerns on this issue various times since 2002.  
He believed that the regulation on traditional expression was inconsis tent with the TBT Agreement. 
His delegation was also ready to engage in discu ssions and submit the necessary documentation to the 
European Communities as required. 
320. The representative of the European Communities  noted that the EC rules concerning the 
common market for wine had been recently reviewed .  This new regulation provided new rules on the 
labelling of products that had to be  further developed by implementi ng rules.  The implementing rules 
were currently being discussed in Council by me mber States working groups.  The implementing 
rules would be notified to the TBT Committee and her delegation looked forward then to having an 
exchange of views on these rules.  She invited those delegations who had comments on the replies 
provided by the European Communities to send them to the EC TBT Enquiry Point.  
(xxi) Israel – Infant Formula 
321. The representative of the United States  reiterated his delegation's c oncerns about the fact that 
a draft regulation on measures relate d to infant formula had not yet been published by Israel, nor had 
it been notified to the WTO.  US industry contin ued to have concerns that Israel's unpublished 
requirements for infant formula were discriminat ory against imports and unduly costly, burdensome, G/TBT/M/46 
Page 60  
 
  and unpredictable.  Israel denied these allegations, yet refused to publish the measures. He stressed 
that the issue could not be resolved until Israel published draft measures governing infant formula for 
comment.  
322. The lack of published requirem ents governing the quality and safet y of infant formula, as well 
as related conformity assessment procedures and labe lling provisions, was of particular concern given 
the 2003 Remedia incident.  It was a difficult position to maintain that infant health in Israel was more 
protected by keeping the Ministry of Health infa nt formula requirements secret, rather than by 
publishing them for the public to review and comment , which was perhaps the most basic of all TBT 
and good regulatory practice principles.  A promising r esolution of this issue had appeared to be near 
this summer, and Israeli authorities were urged to r esume working with industry  to resolve this issue 
in the near term. 
323. The representative of Israel
 pointed out that, due to grave health problems caused by deficient 
imported infant formula, the Ministry of Health ha d been forced to reconsider the import system in 
order to ensure the health and safety of infant f oods.  She highlighted that the issue was sensitive and 
important to Israel and re newed her delegation's invitation to the Un ited States to engage with Israel at 
bilateral expert level in order to fi nd an agreed solution to the issue. 
(xxii)  China - Energy Efficiency and Energy E fficiency Grades for Copy Machines 
(G/TBT/N/CHN/331 and Rev.1 and Suppl.1) 
324. The representative of Japan  was grateful for the reply sent by  China to the comments made by 
his delegation on the above mentioned notified measur e, as well as for the bilateral discussions held.  
However, his delegation still had con cerns on two issues.  First, there was no international example of 
standards in the same field which were compulsory .  For example, the international Energy Star 
Program was a voluntary standard.  The Chinese standard might therefore be an obstacle to 
international trade.  Second, it would not be possibl e to measure energy efficiency accurately, because 
energy efficiency was measured by copy mode in the proposed standard, even  if copy-based machines 
had the function of a printer.  He noted that it was difficult to establish whether machines were copy 
machines or printers and inquired what the criteria for this determination ha d been used by China. 
Finally, he inquired whether China had plans to develop the same standards for printers and fax 
machines and, if so, when a notification would be made.  He stressed that such standards should be 
harmonized with international standards. 
325. The representative of China  stressed that the objective of this standard was to save energy and 
protect the environment, which was in line with the legitimate objectives in the TBT Agreement.  He 
explained that the standard divided energy efficiency  into three grades.  It was only the lowest grade 
(grade three) which was a compulsory requirement .  Both grades one and two were voluntary, and 
grade two was equivalent to the requirements of  the Energy Star Programme. Therefore, his 
delegation believed that this standard would no t cause unnecessary obstacles to international trade. 
326. The representative of China further pointed out th at the scope of the standard was clear: it was 
applicable to copying machines as well as to multi ple functional machine with a copier as a basic 
function.  If the machine was a printer with a copier  as secondary function, it would not be subject to 
the standards.  Similar energy efficiency sta ndards on printers and faxing machines were being 
planned and notification obligations would be fulfilled in due time. 
(xxiii)  Thailand – Labelling Requirement for  Snack Food (G/TBT/N/THA/215 and Add.1) 
327. The representative of the United States  appreciated Thailand's efforts on the revised labelling 
regulation and supported Thailand's go al of promoting healthier citizens.  However, industry groups 
from Thailand and the United States, as well as from other trading partners, had continued to raise  G/TBT/M/46 
 Page 61 
 
 
  questions as to whether the measure was necessary in li ght of potential alternatives.   He recalled that, 
at the last Committee meeting, the United States had requested a status report on the measure, 
particularly in light of the Thai FDA's statement earlier this year that nutrition labelling should be 
directed at all food categories, and that mandato ry labelling requirements for snack foods and other 
foods "deemed necessary" would eventually be put in place "at appropriate stages."  He sought an 
update on the status of this measure from Thai author ities.  He also noted ongoing work in Codex to 
review strategies regarding diet and health, and en couraged Thailand to actively participate in the 
Codex work and to consider approaches that could have the benefit of both encouraging better health 
and facilitating trade. 
328. The representative of Thailand  pointed out that the Thai FDA was willing to enter into 
discussion and work on the issue with the United States.   Concerns raised would again be conveyed to 
the authorities in capital. 
(xxiv)  Saudi Arabia - International Conform ity Certification Programme (ICCP) 
329. The representative of the United States  reiterated his delegation' s concerns about Saudi 
Arabia's apparent failure to abid e by its accession commitments to publicize in English its Conformity 
Certificate requirements.  He stressed that Saudi  Arabia had committed to remove the burdensome 
requirements of its former International Conformity  Certificate Program (lCCP) administered by the 
Saudi Arabian Standards Organization (SASO), a nd replace it with a "Conformity Certificate" 
program to be administered by the Ministry of Commerce and Industry.  Saudi Arabia had also committed to provide detailed public guidance on how to comply with the new conformity assessment 
requirements post-ICCP.  These commitments did not appear to have been fulfilled.  
330. The representative of the United States stressed th at the lack of publicly available information 
on the requirements had created c onfusion and had allowed the company previously contracted to 
provide services for Saudi Arabia's previous certifica tion program to falsely advertise on the internet 
that its services were a mandatory requirement for access to the Saudi market.  Saudi Arabia should 
take steps to dissolve the "ICCP.com" website.  Furt hermore, he urged Saudi Arabia to publish the 
current requirements for product testing and certific ation. Specifically, Saudi Arabia should publish 
the list of entities that it believed were qualified to  complete testing and certification work for the 
country, in order to be clear about which service providers met Saudi requirements.  
331. Moreover, it was noted that Saudi Arabia shoul d also provide: (i) the criteria that Saudi 
Arabia was using to recognize approved test labor atories and certification bodies to provide services 
to the Saudi market; (ii) a formal notificati on process for accrediting or approving such bodies; 
(iii) clear procedures for approved bodies to follow wh en issuing conformity certificates or marks to 
convey that a product complies with the relevant requirements; (iv) whether the procedures would 
change or be superseded once the GCC conform ity assessment scheme was put in place; and, (v) 
whether products that were covered by a Conformi ty Certificate would be grandfathered or would 
enjoy a transition period once the GCC system was fi nalized.  Publication of this information would 
provide the necessary clarity that companies needed  to trade their goods in the Saudi market.  
332. The representative of Korea
 shared the concerns expressed and noted that Korean industry 
had difficulties in exporting to Saudi Arabia.  
C. EXCHANGE OF EXPERIENCES  
333. The Chairperson  proposed, in relation to the work of the Committee on the preparation of the 
Fifth Triennial Review, that any substantive propo sals (such as the two tabled by New Zealand for the 
current meeting) be discussed under the Agenda It em dealing with the Exchange of Experience and 
the Agenda Item on Other Matters (A genda Items 2C and 2D of the cu rrent meeting).  Any procedural G/TBT/M/46 
Page 62  
 
  issues arising from the Review, su ch as the proposed timeline, w ould be discussed under the Agenda 
Item on the Preparation of the "Fifth Triennial Revi ew (Agenda Item 3 of the current meeting).  The 
Committee so agreed
.  
334. The Chairperson drew the Committee's attention to document G/TBT/1/Rev.9 which contains 
the most recent revision of the compilation of th e TBT Committee's Decisions and Recommendations.  
She noted that the present revision, which supersedes all previous G/TBT/1 documents, has two parts.  
Part 1 contains the Committee's decisions and recommendations adopted since 1 January 1995 and 
Part 2 contains the Committee's Rules of Proced ure including Guidelines for Observer Status for 
Governments and International Inte rgovernmental Organizations.   
1. Good Regulatory Practice 
(i) New Zealand – "Regulators' Forum" 
335. The representative of New Zealand  introduced her delegation's submission (G/TBT/W/294) 
outlining New Zealand’s experience with the establishment of a new model for regulatory 
coordination: the Regulators’ Forum.   
336. The representative of Mexico  noted that New Zealand's contribution consolidated and 
strengthened his delegation's convi ction that regulatory systems needed to be as open-ended, 
transparent and participatory as possible. Thr ough more coordination amongs t regulatory authorities 
in different countries there would be more consistency in the fulfilment  of international obligations of 
WTO Members.  It was interesting that the reforms of the domestic regulatory coordination system in New Zealand had included the private sector; in this regard he asked how the new scheme would 
allow for the participation of enterprises , associations, commercial associations.   
337. The representative of New Zealand
 said that there was opportunity for private sector 
participation in discussions on the Board, including for academics and other organisations.  Moreover, 
the private sector would also be invited to partic ipate in meetings of the sub-committees.  A workshop 
on the legal infrastructure and its interfaces with standards had been organized to which private 
entities had been invited (November 2008). An intern et site for the Forum was in development.  
338. The representative of Rwanda  noted that experiences such as the one provided by New 
Zealand were very useful for countries that ha d not yet developed similar types of domestic 
coordination mechanisms. He asked the New Zeala nd delegate to provide some more information 
about the types of government agencies that provided input to the Forum's work. 
339. The representative of New Zealand  noted that Core Board members included the regulatory 
agencies that were responsible for product regulat ions, for instance: New Zealand's energy safety 
regulator (ESS), the transport and health ministri es, the food safety authority, etc. These agencies 
were all involved in product regulation.  
340. The representative of the United States  stressed the importance his delegation attributed to 
domestic regulatory coordination.  In respect of New Zealand's submission, he asked how the Forum 
had been established: had it been through a law or  a decree?  Also, what was the legal relationship 
between the Core Board and the various regulators th at participated; could, for instance, the Board 
take a decision that would be binding – or was it mo re a forum for voluntary information exchange?  
The United States also asked whether New Zealand had considered creating guidelines for developing 
regulations.  This had proven to be useful in the United States – it had entailed the creation of one set 
of guidelines, administered by the U.S. Office of Management and Budge t, to be followed in 
developing regulations.   G/TBT/M/46 
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  341. The representative of New Zealand  said that the forum had been established through approval 
by a Committee; it did not have a legal basis – there was no enabling decree or law.  Moreover, participation was on a voluntary basis.  Regardi ng procedures for developing the regulations – the 
Forum did not have an overriding role; it was a forum for sharing experiences and ideas, it typically 
discussed issues at a very early stage of policy development hopefully pre-empting possible "bad" 
decision by regulators.  
342. The representative of India
 was similarly interested in the legislative enactments pertaining to 
the Forum: what were the legal premises under whic h the Core Board had been established?  He also 
asked, given that closely intertwined roles of the sub-committees (to the Core  Board), whether there 
was any interface between the sub-committees and how the sub-committees coordinated with 
individual regulators.  
343. The representative of New Zealand  noted that many sub-committee members sat on more 
than one committee. Moreover, as the sub-committees reported back to the Core Board, there was 
opportunity for all to be informed. She pointed out that New Zealand, being a small country, did not 
have problems exchanging information.  The estab lishment of a coordination mechanism was simply 
a way being more efficient.  
344. The representative of China  asked what number of staff operated the Forum's secretariat. In 
response, the representative of New Zealand  noted that there was one staff member. 
(ii) US – development on Good Regulatory Practice 
345. The representative of the United States  informed the Committee about two new developments 
with respect to good regulatory practice.  First,  in the United States, the Unified Agenda and 
Regulatory Plan provided uniform reporting of da ta on regulatory and deregulatory actions under 
development throughout the federal government th at covered over 60 departments, agencies and 
commissions. The Agenda was released in the fall and spring of each year. The Plan, which covered 
the subset of higher regulatory priorities, was released in the fall of each year. The Office of 
Management of Budget (OMB) oversaw this. In the fa ll of 2008, the versions of both the Agenda and 
the Plan would include a new “international flag” providing identification for the public in terms of 
whether a planned rule was expected to have im pacts on international trade or investment, or 
otherwise be of international interest. This was a new initiative aimed at making it easier to identify 
potential international trade impacts for interested parties, both in the United States and abroad.   
Also, the representative of the United States noted that in September 2008, the OMB had released 
draft guidance for public comment for agencies to follow when considering the effect of draft 
regulations on international trade and investment.  The guidance had been released as part of OMB's 
2008 Draft Report to the US Congress on the co sts and benefits of federal regulation. 
346. The United States recalled its submission on “Determining the Need to Regulate” 
(G/TBT/W/285) and reiterated its readiness to discu ss ways the Committee could advance the issue of 
good regulatory practice as part of the Fifth Triennial Review.  
2. Conformity Assessment Procedures 
347. The representative of New Zealand  introduced their submission entitled: "A Menu Of 
Options:  New Zealand’s Approach To Mutual Recognition Arrangements (MRAs) and Regulatory 
Cooperation Arrangements" (G/TBT/W/295).  In th is proposal, New Zealand recommended that the 
Committee, in the context of the Fifth Triennial Review, consider (paragraph 27 of the submission): 
(i) Continuing to exchange information on MR As, regulatory cooperation arrangements and other 
arrangements that aim to facilitate  trade with a view to building a better understanding of the issues 
that need to be considered in  the choice of trade facilitation a rrangements; and (ii) Developing G/TBT/M/46 
Page 64  
 
  practical guidelines on how to design efficient and e ffective trade facilitation arrangements within the 
context of risk management approaches.  
348. The representative of Mexico
 stressed the importance of th is issue for the Committee and 
supported the proposed recommendations .  He believed that New Zealand's submission clearly set out 
alternatives aimed at facilitating trade and enhancin g regulatory compliance, including alternatives to 
harmonization.  He believed there was need for mo re information in respect of mutual recognition 
agreements; Mexico could suggest different models  for mutual recognition.  There were various 
conformity assessment organisations and bodies, and different types of agreements involving different 
degrees of access – all of which could have significant effects on trade. 
349. The representative of New Zealand  agreed that there could be  additional models to MRAs 
that could be included; her dele gation's submission was aimed at starting the discussion. Any further 
suggestions or ideas on what else could be included in a more full list of options were welcome. 
350. The representative of India  was particularly interested in modalities to achieve cooperative 
arrangements between various regulatory agencies of di fferent countries, particularly those that were 
about developing models that suited engageme nt between developed and developing countries 
(paragraph 20 of G/TBT/W/295).  Did New Zealand have  anything particular in mind with respect to 
this issue; was there work in progress? 
351. Similarly, the representative of the European Communities  was interested in what was 
referred to as “tailored cooperation agreements” (par agraphs 20-21 and 26).   What was the meaning 
of asymmetrical arrangements? Could New Zealand elaborate and illustrate the proposition that such 
arrangements could be particularly effective when trade flows between partne rs tended to be in one 
direction.  
352. The representative of New Zealand  referred to the most recent MRA that had been concluded 
with China in the context of its free trade agreement. As the agreement had come into effect on the 
1 October, it had not yet been tested.  Nevertheless, the model recognized that both New Zealand and China had certain institutional strengths and that  both countries needed to work within those 
parameters in order to facilitate trade and to bette r manage their regulatory compliance.  Essentially, 
the provisions provided that products from China coming into New Zealand would be assessed against the Chinese regulatory requirements which were set out under China Compulsory 
Certification (CCC) system, whereas products from New Zealand going into China would be assessed 
against the equivalent IEC standards.  This reflected  the fact that trade flows tended to be more from 
China into New Zealand that the other way around – hence the asymmetric obligations that 
nevertheless achieved regulatory compliance objectives.  
353. The representative of Pakistan
 expressed his interest in further discussing the issue of 
regulatory cooperation arrangements. 
354. The representative of the ISO  introduced a submission updating Members on relevant work in 
the ISO in the area of conformity assessment (G/TBT/GEN/78).  In particular, he drew Member's 
attention to ISO's work in relation to developing co untries.  He noted that, together with the UNIDO, 
ISO had published a handbook on the role and opera tion of national standards bodies (NSBs) in 
developing countries.  A second volume would follo w, also in collaboration with UNIDO, dealing 
with issues related to good conformity assessment practices.13  
                                                      
13 http://www.iso.org/iso/fast_forward.pdf   G/TBT/M/46 
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  355. The Chairperson drew th e Committee’s attention to a paper from the OECD  on Evaluating the 
Trade Effects of Suppliers’ Declaration of Conformity (SDoC).14 
3. Transparency 
356. The representative of the United States  informed the Committee that the US Enquiry Point 
had recently begun notifying adde nda indicating that a measure previously notified had been 
finalized.  The addenda would contain a copy of th e final measure which set out the agency responses 
to the questions received from interested stakeholders, including WTO Members and other participants during the regulatory process.  This was intended to increase the level of transparency in 
the US notification process.   Moreover, a new da tabase was being used at the US Enquiry Point 
aimed at covering sub-federal measures. As a result,  the United States had been able to increase the 
number of its sub-federal notifications (during 2008 there had been 56 sub-federal notifications by the 
United States). The representative of the United St ates encouraged other Members who regulated at 
the sub-federal level to consider Article 3.2 of the TBT Agreement and to do their best to identify and 
notify sub-federal measures for comments to the WTO. 
357. The representative of th e European Communities
 informed the Committee that his delegation 
would suggest possible improvements to the implem entation of the TBT Agreement's transparency 
provisions.  For instance, in the view of the European Communities, th ere remained room for 
enhancing the way comments were handled.  Also th e point raised by the United States on sub-federal 
notifications was important.  In general, the Europ ean Communities was of the view that in the past 
years the Committee had accomplished remark able work on transparency; numerous 
recommendations had been developed.  There w as now merit in focusing not necessarily only on 
developing more  recommendations but rather looking at how the existing  body of recommendations 
was actually being applied by Members.  The European Communities intended to share their 
experience in this regard, particularly on how the European Communities had, when necessary, 
modified its internal practices in order to take into account Committe e recommendations.  He 
suggested that the Committee consider developing a questionnaire for Members as a way of gathering 
information about the practical application of the Committee’s recommendations. Some information 
would be purely statistical and simple to gather, fo r instance: the number of cases where final adopted 
texts had been notified by addenda, or the number of instances when draft notified texts had been 
provided in electronic form.   
358. The representative of Mexico  agreed that it was essential th at the Committee focus on trying 
to achieve a correct and complete implementati on of existing provisions and recommendations.  
While the Committee needed to remain open to im provements, there were existing provisions that 
were not fully complied with.  For instance, Mexico  remained concerned about the need for a wider 
implementation of the "early publication require ment" contained in Article 2.9.1 of the TBT 
Agreement.  He supported the statement made by th e United States on the importance of notifications 
at the sub-federal level.  He also noted, in this r espect, that Article 3.2 of the TBT Agreement states: 
"notification shall not be required for technical regulations the technical content of which is 
substantially the same as that of previously no tified technical regulations of central government 
bodies of the Member concerned".  Finally, Mexi co introduced his country’s Supplement to the 
National Standardization Programme  for 2008 (G/TBT/GEN/7/Add.8). 
4. Technical Assistance 
359. The representative of Sweden  informed the Committee about a recently launched technical 
assistance project – a so called "Mentorship Programme" – in support of seven East African countries 
aimed at enhancing the implementation of the TB T Agreement (Burundi, Ethiopia, Kenya, Rwanda, 
                                                      
14 http://www.oecd.org/dataoecd/57/3/41481368.pdf  G/TBT/M/46 
Page 66  
 
  Tanzania, Uganda and Zambia).  Each country ha d two participants: a capital based expert and a 
representative from the Geneva-based mission.  The Programme was aimed at securing an interactive 
dialogue between the mentor and the participants on inter alia : participation in the work of the TBT 
Committee; preparation of notifications and comme nts on notifications; the understanding of the use 
of international standards; and use and functioning of  the enquiry points, including with respect to the 
dissemination to relevant stakeholders.  The Progr amme would run for three years and included two 
key elements: (i) participation in the regular  meeting of the TBT Committee and, (ii) the 
establishment of national working plans on the e nhancement of the implementation of the TBT 
Agreement at the national level.  There would also  be one individual activity each year separate from 
the TBT Committee meetings which was intended to provide more detailed in formation and follow-up 
to participants.   
360. The representative of Burundi
, on behalf of sub-Sa haran African countries , thanked the 
Swedish National Board of Trade15 for the technical assistance they were providing specifically on the 
implementation of the TBT Agreement. The Mentor ship Programme was an example of a concrete 
programme aimed at furthering understanding a nd implementation of the TBT Agreement.   
Participation in the TBT Committee meetings was a particularly important aspect.  Supporting this 
statement, the representative of Zambia  called on other countries to make similar efforts to help build 
capacity in the developing countries in a very pragmatic and concrete way.   
361. The representative of Mauritius  emphasized the importance of technical assistance being 
country driven and fully responsive to the needs of recipient countries.  
D. OTHER MATTERS  
1. Workshop on the Role of Internationa l Standards in Economic Development 
362. The Chairperson  drew the Committee's attention to a proposed structure and a preliminary list 
of topics for the proposed TBT Committee Workshop on The Role of International Standards in 
Economic Development (contained in document JOB(08)/107).   
363. The representative of Chile  offered, for the workshop, to make a presentation of a case study 
on Chilean standards for energy efficiency – to be  presented by Chile's National Standards Institute 
(INN). Experiences on public / private cooperation on st andard setting in the area of energy efficiency 
would be shared, particularly those relating to  the labelling of refrigerators and lamps.   
364. The representative of Brazil  proposed a presentation on standards development in the biofuels 
area.   
365. The representative of Japan  stressed the need to raise awar eness in developing countries about 
the importance of developing countries' participati on in international standardization.  Japan was 
willing to make a presentation on the impact of stan dardization at the micro-economic level, based on 
studies undertaken in Japan.  Japan could also speak  about relevant work in APEC on the alignment 
of national standards with international standards. 
366. The representative of Chinese Taipei  noted that a number of Members, including the United 
Kingdom, Germany, Japan and China, had undertaken  quantitative research ai med at analyzing the 
economic value of standardization.  The use of  widely accepted quantitative methodologies could help 
Members obtain a better picture of the impact of standards on economic growth.  In this regard, 
                                                      
15 Kommerskollegium , the Swedish National Board of Trade 
(http://www.kommers.se/templates/Standard____3127.aspx )  G/TBT/M/46 
 Page 67 
 
 
  Chinese Taipei expressed an interest in making a presentation on the benefits of a harmonized 
assessment methodology for standardization economics.    
367. The representative of Egypt  proposed to share his country's experience on the harmonization 
of national standards with international standards. 
368. The representative of Australia  expressed her delegation's inte rest to making a presentation on 
the economic impact of standards. 
369. The representative of Thailand  flagged her delegation's inter est in making a presentation on 
the use of standards in the area of conformity assessment. 
370. The representative of the United States  noted that the case studies proposed so far would be of 
value to workshop participants because they woul d promote a greater understanding of the mechanics 
of domestic stakeholder engagement in the techni cal work of standards development and in the 
adoption of international standards.  The United States was looking forward to hearing from Pakistan 
on the challenges faced by its small and medium sized  enterprises (SMEs) in the textile sector; and on 
Peru's work in organizing its growers, processors , and exporters with respect to understanding and 
adopting ISO standards.  Likewise, the United St ates would welcome a contribution from Colombia 
on its experience with "twinning" in ISO, and a simi lar contribution from an IEC affiliate could also 
be useful.  The representative of the United States suggested that standards experts from the World 
Bank and UNIDO could be invited to make presentati ons, and that it could be useful to have input 
from the Pacific Area Standards Congress on its work aimed at promoting trade facilitation through the use of international standards.  
371. The representative of the ISO
 drew the Committee's attention to a database of studies on the 
economic benefits of standards ava ilable through the ISO/IEC information.16  He noted that, recently, 
the ISO had decided to support a study on the meth odology used to assess the economic benefits of 
standards which was scheduled to be completed by th e end of 2009; this work could also be shared 
with the Committee. 
372. The representative of the IEC  offered to provide a speaker on the IEC Affiliates Programme. 
373. The Chairperson  said that the proposals had been noted and that these would be taken into 
account for the next revision of the programme.  She asked the Secretariat to seek further input from 
Members as well as relevant international organi zations, as appropriate.  In respect of funding, 
considering the importance attributed by Members to the workshop – as well as the need to ensure 
developing country capital-based participation – she proposed to hold the workshop in early 2009 and 
to postpone the Committee's Sixth Special Meeting on Information Exchange to the following year 
(2010).17  
374. It was so agreed . 
2. Proposal from Canada on Specific Trade Concerns 
375. The representative of Canada , referring to the increasing number of specific trade concerns 
raised in the TBT Committee, noted that a more stru ctured consideration of these concerns would help 
                                                      
16 http://www.standardsinfo.net/info/livelink/fetc h/2000/148478/6301438/benefits/benefits.html  . 
17 Funds allocated in the WTO's Bie nnial Technical Assistance and Tr aining Plan (2008 2009) for the 
TBT Committee's Sixth Special Meeting on Procedures for Information Exchange for officials responsible for Notifications and Enquiry Points will be used to ensure participation at the standards workshop 
(WT/COMTD/W/160, 2 November 2007, p.52). G/TBT/M/46 
Page 68  
 
  improve the implementation and admini stration of the Agreement.   In particular, it would be useful to 
list all the specific trade concerns to be raised at the meeting in the agenda.  In this vein, Canada 
suggested the following procedures: (i) Members wish ing to propose the inclusion of a specific trade 
concern on the annotated agenda should inform bot h the Secretariat and the Member(s) directly 
involved of their intention to do so, in writing, no less than seven days prior to the convening of the 
TBT Committee meeting;  (ii) requests to include  specific trade concerns on the agenda should be 
accompanied by a brief outline of the concern or a reference to the specific TBT notification to be 
raised; (iii) the Secretariat will then issue the a nnotated agenda, including a ll specific trade concerns 
to be raised, as soon as possible but no less than fi ve days before the TBT Committee meeting. The 
Chair and Secretariat propose an order in which specific trade concerns appear on the annotated 
agenda with new concerns to be raised before t hose that have been discussed at previous meetings; 
(iv) there may be instances where a member wishes to bring a concern to the Committee’s attention 
after the deadline has passed. In this case, additional specific trade concerns can  be included in the 
agenda of the TBT Committee meeting under “Oth er Business”. Any discussions on these concerns 
will still be recorded in the formal meeting minutes;  (v) Members responsible for late submissions to 
the Secretariat must make a demonstrated effort to inform the Chair and the Member(s) directly 
involved of their intention to have the specific tr ade concern included under “Other Business.”    
376. The representatives of Chinese Taipei
 and Norway  welcomed Canada's proposal and shared 
the view that there was a need to improve the Commi ttee's procedures for the consideration of specific 
trade concerns, possibly in line with  procedures used by the SPS Committee. 
377. The representative of the European Communities  noted that document G/TBT/GEN/74 
contained a useful overview of the specific trade con cerns raised in the TBT Committee to date – this 
also facilitated the consideration of specific trade concerns.  In general, his delegation agreed that 
Canada's proposal could usefully contribute to a more efficient handling of the agenda item on 
specific trade concerns.  Regarding Point 5 on Ot her Business, the representative of the European 
Communities was concerned with the suggestion that, if a specific trade concern was brought to the 
attention of the Committee after  the deadline had passed, it would be dealt with under "Other 
Business".  He noted that there could be justifiabl e reasons for not being in a position to inform the 
Secretariat in advance of the intention to raise a concern.  His delegation was of the view that it was better to discuss all specific trade concerns under th e same agenda item.  Also, the representative of 
the European Communities asked Ca nada to explain what was meant by "making a demonstrated 
effort" under Point (v), above. 
III. PREPARATION OF THE FIFTH TRIENNIAL REVIEW 
378. In light of the mandate in Article 15.418, the Committee is scheduled to complete its Fifth 
Triennial Review of the Operation and Implementati on of the TBT Agreement at its last meeting in 
2009.  Fifth Triennial Review follows a sim ilar approach to Committee's previous Review19:  it should 
be driven by substantive proposals from Members,  subsequent discussion of these proposals in the 
Committee, and drafting of the report itself.   Based on a proposal from the Chairperson 
                                                      
18 Article 15.4 of the TBT Agreement provides:  "Not later than the end of the third year from the date 
of entry into force of the WTO Agr eement and at the end of each three-y ear period thereafter, the Committee 
shall review the operation and implementation of th is Agreement, including the provisions relating to 
transparency, with a view to  recommending an adjustment of the righ ts and obligations of the Agreement where 
necessary to ensure mutual economic advantage and balance of rights and obligations, without prejudice to the 
provisions of Article 12.  Having regard, inter alia,  to the experience gained in the implementation of the 
Agreement, the Committ ee shall, where appropriate, submit proposals for amendments to the text of this 
Agreement to the Council for Trade in Goods". 
19 The reports of the last four reviews are contained in documents: G/TBT/5, G/TBT/9, G/TBT/13 and 
G/TBT/19.  Document G/TBT/1/Rev.9 contains the ninth revision of the compilation of the TBT Committee's 
Decisions and Recommendations.  G/TBT/M/46 
 Page 69 
 
 
  (JOB(08)/108), the Committee agreed  on the following timeline for the preparation of the Fifth 
Triennial Review: 
(a) 5-6 November 2008 :  TBT Committee meeting (agreement on approach and 
discussion of any substantive proposals submitted) 
(b) mid-February 2009 : circulation by Secretariat of background document compiling 
information available relevant to the review 
(c) 18 – 19 March 2009 : TBT Committee meeting (discussion of substantive proposals) 
(d) 5 June 2009 :  deadline for the submission of substantive proposals by Members  
(e) 24 – 25 June 2009 :  TBT Committee meeting (discussion of substantive proposals) 
(f) July 2009 : circulation by Secretariat of first draft report of the Review  
(g) end-August 2009 : submission of written comments from Members on the first draft  
(h) end-September 2009 :  circulation of final draft report of the Fifth Triennial Review 
(i) 4 – 5 November 2009 :  TBT Committee meeting (adoption of the Review) 
IV. ANNUAL TRANSITIONAL REVIEW (TRM) MANDATED IN PARAGRAPH 18 OF 
THE PROTOCOL OF ACCESSION OF THE PEOPLE'S REPUBLIC OF CHINA 
379. The Chairperson  recalled that, in accordance with Paragraph 18 of the Protocol of Accession 
of the People's Republic of China (WT/L/432), the TBT Committee would undertake an annual review for eight years of the implementa tion by China of the TBT Agreement.   
380. The representative of the United States
 highlighted some issues contained in his delegation's 
submission (G/TBT/W/292).  He recalled that durin g the current TBT Committee meeting, the United 
States had raised two substantive issues (informati on security and excessive packaging) with respect 
to Chinese measures under the Specific Trade Concerns part of the agenda (Part IIB of G/TBT/M/46).  
In addition to these concerns, the United States re quested an update from China on several systemic 
issues which the United States had been following fo r some time. First, could China explain whether 
it had any plans to allow foreign laboratories to  be accredited to conduct testing for mandatory CCC 
mark certification?  Second, could China expl ain whether it was considering the adoption of a 
supplier's declaration of conformity (SDoC) fo r any products covered under the existing CCC mark 
system?  Third, could China explain whether fore ign stakeholders could be voting members on the 
technical committees of Chinese Standards bodies? 
381. The representative of Japan  referred to his delegation's submission (G/TBT/W/293). He noted 
that conformity assessment bodies of foreign countries had not been allowed to engage in certification 
activities in China according to the Article 9 and Artic le 13 of the regulations of the People's Republic 
of China on Certification and Accreditation, pe rmitting only Chinese conformity assessment bodies 
(CABs) to conduct such activities. No foreign CAB had yet been allowed to engage in certification 
activities under the CCC mark system. Pursuant to the provision in Article 6.4 of the TBT Agreement and the commitment in Paragraph 195 of the Report of  the Working Party on the Accession of China, 
Japan requested that local foreign-owned CABs, as  well as foreign-based CABs, be engaged in 
certification activities under the CCC mark system without discrimination.  G/TBT/M/46 
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  382. In respect of administration of the control of pollution caused by electronic information 
products, Japan noted that article 3.3.4 of the Re gulation prohibited "the import of electronic and 
information products that do not meet the national or  industrial standards pertaining to the restriction 
of hazardous substances in electronic and informa tion products".  Since it was difficult for Japanese 
companies to understand from this text which were th e standards that had to be met, Japan requested 
China to specify and provide a list of the standards refe rred to in this article.  It was noted that at the 
last TRM session, in 2007, China had replied that they  were preparing the test standard and that if the 
future IEC standard would be practical for China, they would follow that st andard.  Japan requested 
China to make the objectives of the standard clear and promote it adequately according to Article 2.4 
of the TBT Agreement which requires Members to u se relevant international standards as a basis for 
their technical regulations.  
383. Japan noted that it continued to have con cerns about China's registration system for 
environmental management on the import and e xport of toxic chemicals. The Chinese State 
Environment Protection Agency (SEPA) had released a revision of "Highly Restricted Imported and Exported Toxic Chemicals" on 28 December 2005; it had gone into effect on 1 January 2006.  A total 
of 158 chemicals had recently been added to the revi sed list of toxic chemicals, some of which were 
widely used in the chemicals industry.  The "Re gulations System for Environmental Management in 
the Initial Imports of Chemical Products and th e Import and Export of Toxic Chemicals" ("the 
System") requires companies to pay US$10,000 to SEPA  in order to obtain a Registration Certificate 
for exporting to China the chemicals on the list.  It was pointed out that the Registration Certificate 
was valid for two years per contract. Japan asked how China would deal with the System after the 
expiration of the two-year period.  At the last TRM session, China had replied that stakeholders from 
abroad could participate in the revision process.  At  the last TBT meeting held in July 2008, China 
had answered that this process was still under revi ew. Japan requested more information about the 
status of the revision. 
384. In respect of the notified Chinese technical regul ations related to information security testing 
and certification, Japan shared the view of the Un ited States raised at the last China TRM session.  
385. The representative of the European Communities
 highlighted some points in his delegation's 
submission (G/TBT/W/300), noting that this docum ent also identified other areas where concerns 
remained, as well as areas where progress had been  made.  Some issues raised under the Specific 
Trade Concerns part of the agenda (Part IIB of G/ TBT/M/46) were also related to the TRM exercise.  
386. The European Communities welcomed efforts ma de by China in the field of good regulatory 
practice and noted the significant increase in the fre quency of public calls for comments. In this 
regard China was invited to provide an adequate  period in which interested parties could make 
comments. China was also urged to systematically give public written notice of any regulatory change 
and to establish a single official journal for publishing all the regulations and other measures 
pertaining to or affecting trade in goods. It was also important to provide a reasonable interval 
between the publication of technical regulations, incl uding when they took the form of compulsory 
standards, and their entry into force in order for economic operators to adap t, in accordance with the 
provisions of the TBT Agreement. The European Communities welcomed the unification of testing 
procedures for eight types of medical devices which had previously been subject to separate approval 
procedures managed by AQSIQ and SFDA; he hoped th at this would serve as an example for other 
situations where double or even triple testing o ccurred, such as the case for telecom equipment.  
387. It was noted that concerns relating to the Ch inese Compulsory Certification System (the CCC 
mark system) had been addressed under the Specific Tr ade Concerns part of the agenda (Part IIB of 
G/TBT/M/46).   G/TBT/M/46 
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  388. In the area of standards, the European Co mmunities reiterated its call for foreign owned 
companies established in China to be allowed to pa rticipate in the work of domestic standardization 
processes on an equal footing to Chinese owned stake holders. This was all the more important given 
the peculiar features of the Chinese regulatory system in which most technical regulations took the form of so called "compulsory standards"; the lack  of access to the activities of Chinese standardizing 
bodies effectively excluded foreign stakeholders from a crucial activity in the regulatory process.  
389. The representative of the European Communities emphasized his delegation's concerns in the 
area of ICT products, in partic ular: favouring home-grown standards featuring unique Chinese 
technologies; overly detailed standardization of m obile phone features and components; difficulties in 
placing on the Chinese market innovative products with multimode capabilities; and, multiple and 
partially overlapping certification procedur es managed by different authorities.  
390. In the automotive sector, the Eu ropean Communities continued to have concerns about the 
continuous broadening and deepening of CCC cer tification as applied to automotive components 
regulations.  The European Communities was of the vi ew that the goals of regulating safety, health, 
and environmental concerns with respect to moto r vehicles could be achieved through harmonization 
under the United Nations 1958 Agreement on Motor Vehicles (under the Economic Commission for 
Europe, UNECE).  Thus, the European Communities urged China to become a Contracting Party to 
this Agreement, and also work to eliminate duplica tive, costly and burdensome inspections and testing 
under China’s unique CCC certification and marking system. 
391. In the area of pharmaceuticals, the issue of active pharmaceutical ingredients remained of 
concern to the European Communities given rou tine multi-sampling and testing practices mandated 
for each imported batch of active pharmaceutical ingredients (APIs) by SFDA regulations.  Also on 
pharmaceuticals, the European Comm unities requested China to consider taking measures to reduce 
the current abnormally long clinical trial approval pe riods.  Another source of concern related to the 
National Reimbursement Drug List (NRDL); it was the understanding of th e European Communities 
that the list had not been updated since 2004. Since only products on the list could be reimbursed, 
failure to update it put more recent and innovative drugs at a competitive disadvantage. The European 
Communities urged China to ensure the r egular and systematic update of the NDRL. 
392. In respect of cosmetics, the European Comm unities recalled concerns about the approval 
procedures in place for imported and domestic non-speci al use cosmetics and reiterated its request to 
Chinese authorities to u nify the current notification system. The European Communities also recalled 
its request for MoH and AQSIQ to develop a single h ygiene standard for cosmetics that would replace 
the two standards that were being separately enfo rced by the Ministry of Health (the Hygiene 
Standard for Cosmetics 2007) and AQSIQ (the al ready outdated Standard for Cosmetics GB 7916-
1987), issued in 1987. 
393. In the field of medical devices, the European Co mmunities referred to the concerns raised at 
the Committee's last TRM exerci se regarding duplicative mandatory (re-)registration requirements 
enforced by SFDA and AQSIQ offering no additional safety benefit for patients and users.  The 
European Communities also recalle d concerns about the registration procedures and the need for 
providing an equal level playing fi eld for refurbished medical devices as compared to new medical 
devices.  The European Communities was of the vi ew that the ban on refurbished products was not 
justified on health and safety grounds.  
394. 
Concerning textiles, the European Communities re ferred to previously raised concerns about 
the compulsory certification of silk quality and labelling requirements.  The European Communities 
also joined Japan in requesting a review of China's toxic chemicals legislation.  G/TBT/M/46 
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  395. The representative of China
 referred to his delegation's submissions (G/TBT/W/296) 
providing information relating to Annex 1A of WT /L/432.  In respect of the comments from the 
European Communities regarding China's implemen tation of the TBT Agreement's transparency 
provisions, China noted that they attached great im portance to transparency. To date, China had made 
nearly 500 TBT notifications and provided a 60 day comment period on a regular basis. Moreover, it 
was usual practice to extend this period upon a Me mber's request, and written replies to Members' 
comments were also provided on request. In this regard, China asked Memb ers, especially certain 
developed country Members, to also implement their transparency obligations in good faith.  
396. In respect of the implementation of CCC cer tification for informa tion security products 
(paragraph 5(a) of US submission and paragraph 16 of EC submi ssion), the representative of China 
noted that clarification and information had alr eady been provided under the agenda item of Specific 
Trade Concerns (Part IIB of G/TBT/M/46). 
397. In respect of the draft Amendment to Regul ations on Compulsory Product Certification 
(paragraph 6 of the US submission), it was noted that  major changes had been made in the following 
areas: changes to the sampling approach in product type-test; an administrative system based on type 
of products and enterprises on the inspection of certified products and enterprises by certification 
authorities had been established; and, a pr oduct recall provision had been added.  
398. Regarding permission for foreign laboratori es to be accredited to conduct testing for 
mandatory CCC certification (paragraph 7 of the US  submission, Section 1 of Japan's submission and 
paragraph 13 of EC's submission), the representativ e of China said that the CCC certification system 
had been actively involved in multilateral and mutual  recognition of testing and certification promoted 
by the TBT Agreement.  In accord ance with the Regulations of the People's Republic of China on 
Certification and Accreditation, foreign certifi cation bodies' qualification for CCC certification could 
only be acquired through inter-government agreem ents, agreements recognised by the Chinese 
Government or agreements with competent author ities of the Chinese Government. So far, China had 
signed 20 agreements with agencies or certifica tion bodies from 15 countries or regions which cover, 
for example, factory inspection and the recognition of certification or testing results.  
399. Regarding the adoption of Supplier's Declara tion of Conformity (SDoC) under the CCC  
system (paragraph 8 of US submission), the first priority was to establish whether the conformity 
assessment approach adopted w as capable of effectively achieving the legitimate objectives of 
guaranteeing product safety and protecting consumer inte rests. China was of the view that the use of 
SDoC for products covered under the CCC system c ould not achieve the same level of confidence as 
that achieved by the CCC system, taking into acc ount the special needs of the Chinese market.  
400. Regarding the administration of the control of pollution caused by electronic information 
products (Section 1 of Japan's submission), the repre sentative of China noted that relevant standards 
and technical requirements were unde r development and Japan was encouraged to make a request  for 
information through the TBT enquiry point and other channels.  
401. Regarding China's registration system for the environmental management on the import and 
export of toxic chemicals (Section 3 of Japan's submission), China informed the Committee that it 
was revising its State Council Regulation on Dangerous  Chemicals.  The revision of the registration 
system for toxic chemicals would follow thereafter.  
402. Regarding EC comments on standardization (paragraph 23 to 35 of EC submission), China 
noted that standardization activities in China were c onsistent with the TBT Agreement.  He also noted 
that given the late formal submission by th e European Communities, communications on most 
questions and comments from Members' submissions had already taken place before the meeting, or under other agenda items.    G/TBT/M/46 
 Page 73 
 
 
  403. The Chairperson  thanked all delegations for their st atements and the Committee adopted its 
report on the seventh Annual Transitional Review Report to the Council for Trade in Goods (G/TBT/24). 
V. TECHNICAL COOPERATION ACTIVITIES 
1. Technical Cooperation Activities by Members 
404. The representative of th e European Communities
 drew the Committee’s attention to a list of 
TBT related technical assistance projects that were  active in 2006 and 2007 financed either by the 
European Commission or by the EU member States (G/TBT/W/303). 
2. First Specialized Course on The TBT Agreement 
405. The representative of the Secretariat  briefed the Committee on the First Specialized Course on 
the TBT Agreement (held the two weeks from 27 October to 7 November 2008). The Course was 
organized by the Trade and Environment Division as part of the 2008-2009 Technical Assistance and Training Plan. The 25 selected participants were  officials nominated by their governments from 
developing country Members or Observers, including LDCs.  It was stressed that the purpose of the 
Course was to promote greater understanding of th e TBT Agreement and to address implementation 
challenges related to the Agreement in a practical manner.  It was also intended to enhance and give 
more effectiveness to participation in TBT Comm ittee work.  The Course comprised a series of 
sessions and practical exercises related to the impl ementation of the Agreement.  The first week 
included both general sessions to increase understa nding of the TBT Agreement, and focused sessions 
on topics such as transparency, use of relevant international standards, conformity assessment 
procedures and other aspects of the Agreement.  During the second week the course focused on the 
operation of the Committee itself.  An integral part of the Course was to address specific 
implementation challenges identified during the course.
20  
VI. UPDATING BY OBSERVERS 
406. The representative of UNECE  updated the Committee on the work of the UNECE Working 
Party on Regulatory Cooperation and Standardizati on Policies (WP.6) which held its 18th session on 
3-4 November 2008 .  The Working Party discussed standa rdization policies, in particular the issue of 
reference to standards in regulations.  In the area of regulatory cooperation, advances were examined 
in various sectors under the "Model for the Harmonization of Technical Regulations" (Recommendation L). The importance of metrology in conformity assessment was highlighted by the revision and renaming of the recommendation to "Metrological Assurance of Conformity Assessment and Testing" (Recommendation K).  The Working Pa rty also began developi ng a general model for 
supporting the decision making process of market su rveillance authorities under the "Use of Market 
Surveillance Infrastructure as a Complementary Me ans to Protect Consumers and Users against 
Counterfeit Goods" (Recommendation M).  A break-out session on the issue of private standards was held, where several practical means of assisting SMEs were discussed.  This included making transparent and predictable information readily available to exporters. 
407. The representative of the Codex
 drew the Committee's attention to document G/TBT/GEN/75 
containing an update on relevant Codex work.  She highlighted, in particular, the work of the 
FAO/WHO Coordinating Committees.  Also, in respect  of the TBT Committee's efforts to promote 
the participation of developing countries in standard izing activities, she noted that prior to the Codex 
Coordinating Committee for Asia (to be held in I ndonesia) there would be a meeting about improving 
                                                      
20 More information on other technical assistance activities by the Secretariat in 2008 is contained in 
document G/TBT/GEN/77.  G/TBT/M/46 
Page 74  
 
  participation in CODEX standard setting process.  This meeting would be funded by the FAO/WHO 
Project and Fund for Enhanced Participation in  Codex (Codex Trust Fund).  In addition, the 
representative of Codex drew the Committee's attention to the fact that, after five years of work, the 
International Task Force on Harmonisation and E quivalence in Organic Agriculture (UNCTAD, FAO 
and IFOAM) had now finalized its work.  The ITF,  funded by Sweden, Norway and Switzerland, had 
elaborated useful tools on the development of equi valence agreements, as well as valuable guidance in 
the area of organic certification, organic standards,  and criteria for organic certification bodies.  This 
was aimed at reducing the difficulties – especially fo r developing countries – of access the market for 
organic products. Now that this international work had been completed, work would continue at the 
regional level and/or national level to im plement the tools, guidance and criteria. 
408. The representative of the IEC
 briefed the Committee of relevant work (the full report is 
contained in document G/TBT/GEN/76). 
409. The Chairperson drew the Co mmittee’s attention to relevant information from the OECD  on 
recently completed and forthcoming analytical work and events (G/TBT/GEN/79). 
VII. REPORT (2008) OF THE COMMITTEE ON  TECHNICAL BARRIERS TO TRADE 
410. The Committee adopted  its 2008 Report to the Council for Trade in Goods (G/L/871). 
VIII.  DATE OF THE NEXT MEETING 
411. The next regular meeting of the TBT Co mmittee will take place on 18-19 March 2009, 
preceded by the Workshop on the Role of Internat ional Standards in Econom ic Development, on 
16-17 March.   
 
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