RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/53 
26 May 2011 
 (11-2608) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 24-25 MARCH 2011 
 
Chairperson:  Mr. Amit Yadav (India)
 
 
Note by the Secretariat1 
 
   
I.  ADOPTION OF THE AGENDA.............................................................................................2  
II.  IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................2  
A. 
STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2..................................................................2  
B.  SPECIFIC TRADE CONCERNS .........................................................................................................2  
C.  EXCHANGE OF EXPERIENCES .....................................................................................................58  
D.  OTHER MATTERS .......................................................................................................................65  
III. SIXTEENTH ANNUAL REVIEW OF  THE IMPLEMENTATION AND 
OPERATION OF THE TBT COMMI TTEE AGREEMENT UNDER ARTICLE 
15.3 ........................................................................................................................... ................65  
A.  ANNUAL REVIEW .......................................................................................................................65  
B.  THE CODE OF GOOD PRACTICE ...................................................................................................65  
IV.  TECHNICAL COOPERATION ACTIVITIES...................................................................65  
V.  UPDATING BY OBSERVERS .............................................................................................66  
VI.  ELECTION OF CHAIRPERSON ........................................................................................67  
VII. DATE OF THE NEXT MEETING .......................................................................................67  
 
                                                      
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/53 
Page 2  
 
  I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3704. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. 
STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
2. The Chairman recalled that the latest list of  statements submitted under Article 15.2 of the 
TBT Agreement is contained in G/TBT/GEN/1/Rev. 10, issued on 22 February 2011.  He noted that 
since the previous meeting of the Committee, Is rael had submitted a supplement to its original 
statement (G/TBT/2/Add.72/Suppl.1) and Cuba had submitted a revision to their original statement 
(G/TBT2/Add.13/Rev.1).  The Chairman said that in  total, since 1995, 121 Members had submitted at 
least one Statement on implementation under Article 15.2.   He recalled that the latest list of enquiry 
point contacts is contained in document G/TBT/ENQ/37, issued on 15 June 2010. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns  
(i) Brazil – Draft Resolution No. 112, 29 November 2010; maximum levels of tar, nicotine and 
carbon monoxide permitted on tobacco products and prohibition of additives 
(G/TBT/N/BRA/407) 
3. The representative of Turkey  raised concern over Brazil's draft resolution which would define 
permitted levels of tar, nicotine and carbon monoxide in cigarette smoke and prohibit the use of a 
comprehensive list of additives (listed in the annex to the resolution) in all tobacco-related products 
manufactured and sold in Brazil.  Turkey did not question the legitimate objective of Brazil's 
regulation, namely, the protection of human hea lth and prevention of deceptive practices, but was 
concerned with the procedures that Brazil had chos en to achieve it.  The representative of Turkey 
explained that the additives prohibited included any substance or compound other than tobacco and 
water, whether used to process, manufacture or pack tobacco-based products including flavourings, 
aromas and ameliorants.   
4. He explained that some of the banned add itives were essential components of Burley and 
Oriental tobacco, used in blended cigarettes and th at as a result, the regulation would effectively ban 
blended tobacco products from the market.  Prohibiting blended tobacco products would 
unintentionally favour non-blended tobacco product s and go against the stated objectives of the 
regulation.  Turkey was of the view that the re gulation was more trade restrictive than necessary and 
would violate Article 2.2 of the TBT Agreement.  
5. Moreover, the representative of Turkey ques tioned the choice of additives included in the 
annex to the draft resolution.  He explained that some additives were essential components for 
blended cigarettes and did not give  any characterizing flavours to the product, leaving blended and 
non-blended products with the same taste.  Turkey w as of the view that Brazil had based its decision 
on the ingredients exclusively, without considerin g the effects of such ingredients on the final 
product.  By grouping the additives used during the blending process and those lending strong 
characterizing flavours into the same category, the regulation would violate Article 2.8 of the TBT 
Agreement.  He asked whether less trade restric tive measures, such as only limiting additives with 
characterizing flavours, had been considering.  
6. Furthermore, he noted that Brazil had not cited any studies, as required in the TBT 
Agreement.  He claimed that there was no scientific  evidence to demonstrate that additives used in  G/TBT/M/53 
 Page 3 
 
 
  blended tobacco made those products either more attr active for consumers, more harmful to health or 
more addictive.  He requested Brazil to provide evidence that the additives used for blending tobacco, 
as included in the draft resolution, posed increased  risk for human health.  He also asked for 
comparative data on the attractiveness of blende d versus non-blended ciga rettes, and data on the 
human health risks of additives used for blending ve rsus additives that gave characterizing flavours.  
He concluded by noting that Turkey produced 80,00 0 pounds of Oriental tobacco annually, and stated 
that Brazil's regulation would affect Turkis h social, economic and export interests.   
7. The representative of Malawi  noted that, in banning additives in tobacco products and 
prohibiting the manufacture and sale of cigarettes co ntaining any ingredients other than tobacco and 
water, Brazil's regulation would effectively ba n the manufacture and sale of traditional blended 
cigarettes produced using Burley tobacco.  Malawi w as of the view that Brazil's draft resolution was 
even more restrictive than legislation adopted by Canada in 2009 – Bill C-32.  He noted however that 
while traditional blended cigarettes held a very smal l market share in Canada, they made up almost 
100 per cent of the cigarettes currently sold in Brazil.  Malawi did not object to Brazil's public health objective of reducing the incentives for young people to smoke, but believed that the proposed 
legislation was not an appropriate international m odel for the regulation of ingredients, since it had 
not been based upon any meaningful scientific assessment  or evaluation of ingredients.  He noted that 
Malawi's concerns over Brazil's regulation were the same as its concerns over Canada's Bill C-32.    
8. The representative of Malawi claimed that ther e was no reliable evidence to suggest that the 
use of flavours caused minors to begin smoking.  Inst ead, he claimed that evid ence, and research that 
existed on the subject, indicated that ingredients were  an irrelevant predictor for smoking.  Societal 
influences including peer pressure, parental or family  influence and the desire to be perceived as 
fashionable, independent and more "grown up" were widely acknowledged as the primary 
explanations for smoking uptake by young people.  Moreover, research had demonstrated that there 
was no significant difference in smoking prevalence between American blend and Virginia style dominated markets.  As such, Malawi was of the vi ew that the legislation proposed by Brazil would 
pose an unnecessary obstacle to international trad e, violating Articles 2.2 and 2.8 of the TBT 
Agreement. 
9. The representative of Malawi also expressed con cern that Brazil's legislative model could be 
adopted on a wider basis.  Should this occur, he  explained that many consumers worldwide who 
traditionally preferred American blend cigarettes would no longer have legitimate access to their 
preferred product.  Such a situation could in centivise illicit trade in counterfeit and contraband 
cigarette products.  Additionally, the ability of t obacco manufacturers to develop new products would 
become compromised.  In particular, he said th at the legislation would disproportionately harm 
producers of Burley tobacco, including the approxima tely 700,000 farmers wh o cultivated tobacco in 
Malawi.  He explained that Malawi was the world' s largest exporter of Burley tobacco, accounting for 
approximately 25 per cent of world production, w ith an approximate annual crop volume of 208,682 
metric tonnes.  The tobacco industry in Malawi c ontributed approximately 13 per cent of the country's 
GDP and 60 per cent of its foreign exchange ear nings.  Given that tobacco was Malawi's most 
important cash crop, that the tobacco industry was the main driver of growth for the economy, and 
that all of Malawi's Burley tobacco was bought by cigarette manufacturers to be used in the 
international production of traditi onal blended cigarettes, the consequences of Brazil’s proposed 
legislation being adopted on a wider basis would be unthinkable. 
10. Malawi recognized the health ri sks associated with the use of  tobacco products, and was of 
the view that the development of an appropriate and proportionate internati onal framework to regulate 
the industry, based on sound scientific evidence, was both necessary and right.  However, Malawi 
considered that the legislation being proposed by  Brazil was not an appropriate international model 
for the regulation of ingredients, given the scientif ic evidence available and the likely consequences of 
adopting this legislation more widely.  G/TBT/M/53 
Page 4  
 
  11. The representative of Malawi called on Brazil to refrain from implementing the proposed 
regulations and to consider less restrictive measur es that would comply with WTO obligations while 
safeguarding the economic well-being of Malawi.  Fu rthermore, Malawi calle d on Canada to overturn 
Bill C-32, and also called on other Members to refrai n from adopting similar legislation in the future. 
Finally, he noted that Brazil had ratified the Wo rld Health Organization's Framework Convention on 
Tobacco Control (FCTC) and asked Brazil whether it's current proposal contradicted or implicitly 
undermined the purpose and spirit of the interpretive d eclaration it had made.  He noted that Malawi, 
and the Executive Council of the African Union
2, had endorsed the Declaration of the African 
Ministers of Trade on the Framework Convention on Tobacco Control. 
12. The representative of Zambia  explained that while his delegation did not question the 
objective of Brazil's measure, namely of protecti ng human health and preventing deceptive practices, 
Brazil's regulation could have major trade implicat ions, and could violate Article 2.2 of the TBT 
Agreement.  He informed the Committee that the Brazilian measure  had been extensively discussed 
during the WHO FCTC Fourth Conference of the Par ties held in 2010.  Furthermore, Zambia was of 
the view that the submissions by the Working Gr oup on Article 9 of the FCTC had not been fully 
adopted and as a result, the mandate of the Worki ng Group had been extended to the Fifth Conference 
of the Parties, scheduled for October 2012.  In  particular, the Working Group on Article 9 would 
undertake further work on issues relating to the definition and measurability of attractiveness and 
palatability of ingredients necessary in the productio n of traditionally blended cigarettes.  He noted 
that Brazil had fully participated in past deliberations.   
13. Because of the potential implications of the Brazilian and other similar measure on 
traditionally blended cigarettes, and the tobacco varieties specific to blended cigarettes, the 
representative of Zambia posed a number of questi ons:  What scientific evidence and experience from 
other countries had Brazil considered in preparing this  regulation?  On the basis of that evidence, how 
would banning the production and sale of tobacco-b ased products containing additives protect human 
health and deceptive practices in Brazil?  What sci entific evidence had been used to measure the 
effect of ingredients on the pala tability of tobacco products?   
14. He also questioned why Brazil had gone forward with its regulation, which it had stated was 
based on the WHO FCTC, when the relevant FCTC Working Group had not finished its work.  He 
reiterated his understanding that the guidelines bei ng prepared by the Working Group would not be 
completed until October 2012.  Because the outcome of the Working Group on Article 9 would serve 
as useful guidance for countries contemplating possible measures, Zambia saw Brazil's measure as 
premature.   
15. Moreover, the representative of Zambia said that the Brazilian measure posed systematic 
concerns for traditionally blended tobacco products.  In this regard, he noted that the Fourth 
Conference of the Parties to the FCTC had recognized the difficulties that could be associated with blanket measures such as a total ban, and that general discussions had favoured restriction over 
prohibition.  He noted that Zambia was ready to enga ge with Brazil on this matter, either bilaterally or 
through other channels. 
16. Finally, he commented that tobacco-related trad e concerns had been on the agenda of the TBT 
Committee for some time, and were likely to cont inue to be discussed as Members adopted such 
measures to meet their national policy objectives and fulfil regional or multilateral obligations.  In 
order to facilitate coordination at the national leve l, and to ensure the supportiveness of obligations 
undertaken by Members is various multilateral fora, the representative of Zambia proposed that the 
TBT Committee organize a joint meeting with the WTO and FCTC.  Zambia was of the view that it was important to find a lasting solution and that th is approach would be the most effective way of 
                                                     
 
2 Doc. EX.CL/631(XVIII), (African Union, 31 January 2011).  G/TBT/M/53 
 Page 5 
 
 
  addressing Members' tobacco concerns in a holistic  manner.  He highlighted that this discussion 
closely mirrored similar discussions on specific trade obligations set out in multilateral environmental 
agreements in relation to WTO rules.   
17. The representative of Mexico  stated that his delegation shared Brazil's objective of protecting 
human health.  However, he was worried that th e Brazilian measure not only followed the same path 
as the Canadian Bill C-32, but was in fact more rest rictive since it also banned menthol.  He noted that 
while Mexico’s exports of tobacco products to Brazil were currently limited as compared to other 
Members, the proposed regulation would impose a barrier to future growth potential.   
18. The representative of Mexico elaborated four sp ecific concerns with the Brazilian measure.  
First, relating to Article 2.9 of the TBT Agreem ent, it was Mexico's understanding that after the 
deadline of 31 March 2011 for presenting public co mments on the draft resolution, Brazil could 
potentially implement the measure immediately, without Congress examining it.  He asked for 
clarification on whether Brazil intended to impl ement the measure immediately following the 
deadline of public consultation. 
19. Second, it was the view of Mexico that the meas ure was inconsistent with Article 2.2 of the 
TBT Agreement as it was more trade restrictive than  necessary to achieve the legitimate objective of 
protecting public health.  He explained that othe r countries had successfully used less restrictive 
measures, such as limits on additive levels, without  banning their use, to reach their human health 
objectives.  He also echoed previous interventions to  the effect that, to date, no study or scientific 
evidence supported regulation of the type proposed by Brazil's draft resolution. 
20. Third, he noted that technical regulations shoul d be based on the use of products rather than 
design or descriptive characteristics.  As such, by regulating ingredients per se  instead of only tobacco 
products that presented certain characteristic add itives, he believed that Brazil's regulation was 
contrary to Article 2.8 of the TBT Agreement.  
21. Fourth, he stated that the fact that Brazil’s draft regulation was purportedly based on the 
WHO FCTC had no relevance as to whether the me asure was in line with WTO Agreements, as 
would be the case with any convention in another in ternational organization di recting the actions of 
Members, since the WTO Law System was in general self-contained.  Moreover, he claimed that Brazil's proposed measure did not even fall within th e mandate of the FCTC.  At the FCTC's fourth 
Conference of the Parties (COP 4) in November 2010, Parties had partially adopted the guidelines of 
implementation of Articles 9 and 10 of the FCTC.  He elaborated that section 3.1.2 of these guidelines 
had established that measures considered necessary to  regulate ingredients of tobacco products would 
have to be based on conclusive scientific ev idence and on the experience of other countries.
3    
22. In spite of the fact that these guidelines allowed for restrictions on the u se of ingredients, he 
explained that Parties at COP 4 had deemed it n ecessary to have additional scientific evidence to 
establish links between the banning  of ingredients and the addic tiveness or toxicity of tobacco 
products.  Indeed, this point was to be further discu ssed at COP 5 in 2012.  As such, Mexico was of 
the view that Brazil's proposed measure was premat ure.  Moreover, Mexico was concerned that a 
tobacco producer such as Brazil was following a pr ecedent that could lead to confusion for other 
Members as to how they should regulate tobacco pro ducts.  He echoed Zambia's proposal to organize 
a joint meeting with the WHO Secretariat of the FCTC so as to increase awareness of TBT issues and 
coherence with other inte rnational organizations.  
                                                      
3 Partial guidelines for implementation of Artic les 9 and 10 of the WHO FCTC, FCTC/COP4(10), 
November 2010. G/TBT/M/53 
Page 6  
 
  23. The representative of Indonesia
 requested clarification on a number of issues related to 
Brazil's draft regulation.  First, regarding the defi nition of tobacco products , he asked whether these 
definitions extended to crafted cigarettes.  Sec ond, he asked what international laws Brazil had 
referred to in establishing maximum levels of pe rmissible tar, nicotine and carbon monoxide.  Also 
had sought further explanation as to  the rationale for the inclusion of each additive, and whether the 
prohibition applied to both sm oke and smokeless products.  
24. Third, he explained to the Committee that Article 4 of the draft resolution prohibited the use 
of any description on tobacco product packaging or a dvertising materials that could give consumers 
misleading information.  Referring to words such as class, ultra-low content, low content, soft, light, 
mild, moderate, and high-content, he asked Brazil to  clarify which words were prohibited and provide 
examples of words still permitted.  In this regard, he  asked whether Brazil planned to initiate a process 
to pre-approve packaging and whether the use of  brand names which cont ained prohibited words 
would also be banned.  
25. Fourth, he noted that Annex I to the Brazilian draft resolution outlined a number of 
exceptions to the ban on the use of additives, for in stance, additives that were required to manufacture 
tobacco products had been excluded.  He asked Brazil to explain how and why certain types of 
additives could be excluded from the ban.  Fifth, he observed that in Article 3 of the draft resolution, 
limits for tar, nicotine and carbon monoxide in the ci garettes sold in Brazil had been determined by 
quantitative laboratory analysis.  He asked which st andard Brazil had used to determine quantitative 
analysis and the kinds of laboratories that were recognized to perform the analysis.   
26. Finally, in relation to Article 2.9.2 of the TBT Agreement, he noted that Article 4 of Brazil's 
draft resolution stated that the measure would take ef fect immediately.  He asked for clarification on 
this matter, and in particular, if and how long a transition period for compliance would be permitted 
for manufacturers and importers of cigarettes.  If the measure was to apply immediately, he asked if this meant that Brazil regarded the problem as  urgent, as described in Article 10 of the TBT 
Agreement.  
27. The representative of Tanzania
 noted that Tanzania was one of Africa's major tobacco 
growing countries, and that Brazil's proposed law w ould disrupt his country's tobacco leaf exports and 
imports.  He explained that the Brazilian market  was predominantly a traditional-style blended 
cigarette market.  Traditional blende d products used different grades of Burley, Virginia and Oriental 
tobacco and required blending with certain ingredient s, which the Brazilian law sought to prohibit.  
As such, tobacco manufacturers in Brazil would no longer to able to manufacture traditional blended 
cigarettes for the Brazilian market, or for export, which would have a negative impact on imports of 
tobacco into Brazil, including tobacco from Tanzania.  
28. The representative of Tanzania further explai ned that the Brazilian draft resolution would 
introduce significant changes in tob acco blends, which would in turn impact demand for different leaf 
grades of Burley, Virginia and Oriental tobacco.  Ta nzania was of the view that the draft resolution 
was more trade restrictive than n ecessary to meet the legitimate objective of protecting public health.  
In particular, the draft resolution would have a dev astating impact on Tanzania's tobacco leaf exports 
and Tanzania's long-term tobacco crop development pr ospects.  Tanzania produced an annual crop of 
approximately 12,000 metric tonnes, the majority  of it being Virginia tobacco.  Moreover, 
approximately 100,000 fam ilies were involved in growing tobacco, with over 95 per cent of the crop 
being exported to manufacturers worldwide, includ ing Brazil.  This gene rated annual revenue of 
USD231 million in export earnings.  He noted that any measure that restricted blended cigarettes 
would therefore have devastating implications on Tanzania's earnings.  Other cash crops had been 
struggling in global markets in terms of price, and tobacco had become the leading cash crop in Tanzania.    G/TBT/M/53 
 Page 7 
 
 
  29. He stated that the Brazilian draft resolutio n could easily be implemented in a less trade 
restrictive manner, while still meeting its objective.   He reminded the Committee that Article 2.2 of 
the TBT Agreement prohibited WTO Members from adop ting technical regulations that had the effect 
of creating unnecessary obstacles to trade meaning that  technical regulations shall not be more trade 
restrictive than necessary to fulfil a legitimate objective, taking into account the risks that non-
fulfilment will create.  He asked Brazil to explain how its draft resolution was consistent with these 
requirements.  
30. The representative of Tanzania also noted that only partial guidelines on Articles 9 and 10 of 
the WHO FCTC had been adopted during its Conference of the Parties in November 2010.  In particular, section 3.1.2 of the guidelines had placed emphasis on the n eed for scientific foundation of 
measures.  Tanzania was also of the view that Brazil had not demonstrated that traditional blended 
cigarettes exhibited discernable flavours. 
31. Finally, he explained that Article 12.3 of the TBT Agreement required Members to ensure 
that their technical regulations did not creat e unnecessary obstacles to exports from developing 
country Members.  According to Tanzania's in formation, Brazil importe d over USD6 million of 
tobacco from least-developed countries, Tanzania  included, and over USD60 million from other 
developing countries.  As such, Brazil's resoluti on would negatively impact developing countries, 
particularly LDCs, whose developm ent Brazil had always supported.   He urged Brazil to adopt a 
regulation that would take these concer ns and obligations into account.  
32. The representative of Zimbabwe
 also supported the health objective behind Brazil's 
regulation, but cautioned that this topic needed to  be addressed in a scientific manner, which did not 
contradict the TBT Agreement.  He explained th at Zimbabwe was one of the major producers of 
Burley and Virginia tobaccos;  that the industry generated employment for many Zimbabwean families; and that tobacco was th e country's largest foreign currency earner.  If implemented, the 
measure would have a devastating effect on employm ent, foreign currency earning and on the general 
state of the Zimbabwean economy.  He urged Brazil to wait until after COP 5 of the FCTC to proceed 
with its legislation on this topic.  He noted that  basing regulations on scientific evidence and the TBT 
Agreement would facilitate trade rather than obstruct it.  
33. The representative of the Dominican Republic
 shared the concerns of others and explained 
that by prohibiting additives, Brazil's regulation constituted a de facto  prohibition on the manufacture 
and sale of traditional blended cigarettes, and the addi tives used therein.  As a result, this would give 
rise to a prohibition on the use of Burley and Oriental tobacco in Brazil.  Conversely, Brazil's 
regulation would allow the conti nuous production of cigarettes fr ee of additives, using only cured 
tobacco, of which Brazil was the world's largest producer.   
34. The Dominican Republic was of the view that Brazil's measure did not comply with Articles 
2.2 and 2.8 of the TBT Agreement.  He elaborated that in order to determine whether a measure was 
excessively trade restrictive, Members had to cons ider scientific and technical information.  In 
particular, he expressed concern that the measure was more trade restrictive than necessary.  His 
delegation believed that the measure sought to  prohibit traditionally blended cigarettes, 
notwithstanding the lack of scientific evidence showing that they provided tastes and flavours different from the characteristic ones of tobacco.  Furthermore, the measure was incompatible with 
Article 2.8 of the TBT Agreement, since it was based  on design or descriptive characteristics.  As an 
alternative, the representative sugg ested that Brazil prohibit tobacco products that presented fruity or 
sweet flavours, different from tobacco.   
35. He asked whether Brazil's proposed measure had been based on scientific evidence.  
Specifically, he asked whether scien tific evidence existed showing that  flavours that do not provide 
distinctive flavours such as fruit or sweets could give  rise to an increase in smoking.  Furthermore, he G/TBT/M/53 
Page 8  
 
  inquired if there exited evidence showing that traditional cigarettes were particularly attractive to 
youths as compared to cured tobacco, or that a dditive-free tobacco products were less harmful or 
addictive than tobacco products cont aining additives.  If such evidence existed, he requested that it be 
shared with the Committee.  He also asked if othe r legislative solutions had been examined and how 
effective these alternatives were in terms of re ducing the incidence of smoking as compared to the 
proposed measure.  Finally, he inquired whether Br azil had carried out an evaluation of the potential 
impact of the draft resolution on the production and trade in cigarettes.  
36. The representative of Mozambique
 noted that while his delegation did not object to the 
objective of protecting human health, behind Brazil' s proposed regulation, Mozambique, as a tobacco 
growing country, was concerned about the possible implications for tobacco leaf exporters.  He 
claimed that by banning additives, the measure wo uld effectively ban trad itional blended cigarettes 
and ban the use of Burley and Oriental tobacco in  Brazil.  He expressed concern that the measure 
would negatively affect Mozambique's export re venue and economic and de velopment prospects.  
37. He explained that Mozambique exported USD2 milli on per year in terms of tobacco to Brazil.  
This amount was significant for Mozambique who hoped to see increased tobacco export volume to 
Brazil.  He requested that Brazil adopt a measure that did not create technical barriers to trade for 
tobacco originating from developing countries, for which tobacco was often a main export product.  
He supported Zambia's proposal to organize a jo int discussion between the WHO and WTO on this 
matter.  
38. The representative of Ecuador  noted that his country was an exporter of tobacco and tobacco 
blends to Brazil.  He his delegation recognized the legitimacy of the objective of protecting human 
health.  However, he reminded the Committee of Memb ers' obligations to not adopt regulations that 
could create unnecessary barriers to trade, in line with  Articles 2.2 and 2.8 of the TBT Agreement.  
He elaborated that for measures to be in complia nce with the TBT Agreement, they needed to be 
backed by technical analysis and sufficient scientific evidence to justify their adoption or 
promulgation.  Ecuador was of the view that Brazi l had alternative political options, which could be 
effective in reaching their legitimate  objective without prohibiting in a de jure or de facto  way, the 
trade of tobacco in the Brazilian market.  Finally, he supported Zambia's earlier proposal, noting that this would help clarify the necessary measures fo r the control of tobacco consumption and the 
obligations that Members have unde r the multilateral trading system. 
39. The representative of Jordan
 noted that his delegation supported the Brazilian measure's 
objective of protecting human health.  However, he suggested that when dealing with human health, 
scientific evidence needed to exist.   Hence, he questioned whether sci entific evidence existed in this 
regard and whether the Brazilian measure was in line with Brazil's obligations under Article 2.2 of the 
TBT Agreement. Jordan was of the view that th e Brazilian measure was far more restrictive than 
necessary.  
40. The representative of Kenya  informed the Committee that his delegation would submit 
written questions to Brazil later that day.  
41. The representative of the Former  Yugoslav Republic of Macedonia  expressed concern with 
the direct effect of the implementation of Brazil's proposed regulation on trade in Oriental tobacco, of which Macedonia was the second largest exporter to Brazil in 2010.  Moreover, he cautioned that 
such a regulation would jeopardize the vulnerable economies of countries in transition and least 
developed countries, especially in a period wh en Members were not progressing on the Doha 
Development Agenda, and were feeling the negative effects of the global economic crisis.  
42. The representative of Chile
 was concerned that this type of measure could act as an 
unnecessary barrier to trade.  For this reason, he called on Brazil to provide the scientific evidence  G/TBT/M/53 
 Page 9 
 
 
  upon which they had based their measure.  He re iterated that the WHO FCTC guidelines detailed the 
necessity of scientific evidence before taking regu latory decisions.  While Chile supported the 
legitimate objective of reducing the consumption of t obacco products in order to protect public health, 
they considered this measure more  trade restrictive than necessary.  
43. The representative of Nicaragua  considered that Brazil's regulation would restrict trade in 
tobacco products more than necessary.  More speci fically, the measure would form an obstacle to 
trade, violating Article 2.2 of the TBT Agreement.   She explained that while the objective behind the 
measure that Brazil had set forth in its notifica tion to the WTO was recognized under Article 2.2 of 
the TBT Agreement, Nicaragua was not aware of any scientific evidence upon which the measure had 
been based, notably pertaining to the use of additives and human h ealth.  She requested that Brazil 
provide information on the scientific evidence upon which they had based the development of this 
measure.   
44. The representative of Honduras  joined others in voicing concer n over the impact that Brazil's 
regulation would have on its exports.  She noted  that Honduras recognized the protection of public 
health as a legitimate objective, but was of the vi ew that the Brazilian measure was excessive and 
would generate unnecessary barriers to trade.  She ex plained that the measure would prohibit virtually 
all additives (including menthol) instead of only pr ohibiting pertinent additives, as was the case in 
other jurisdictions.  As such, this could represent a de facto  prohibition to the trade of certain tobacco 
products.     
45. She noted that the Brazilian measure would pr ohibit the use of Burley tobacco in Brazil, 
which Honduras produced.  This would cause Honduras' e xports to fall, lead to job loss, and dampen 
the country's economic prospects, especially gi ven the scarcity of alternatives for Honduras.  
Moreover, she claimed that the measure had not been based on scientific evidence proving that a 
specific flavour or certain additive would give ri se to a certain pattern of consumption or make 
tobacco products more attractive.  
46. She recalled Articles 2.2 and 2.8 of the TBT Ag reement, and suggested that other types of 
measures could be put in place that would not have an  impact on the final elaboration of the product.  
Moreover, regarding Article 12.3 of the TBT Agreem ent, she noted that Brazil's measure would create 
an unnecessary obstacle to the income of developing c ountries.  She asked Brazil to explain how they 
would take into account the special circumstances of developing countries. 
47. The representative of Cuba  echoed the concerns expressed by others regarding Brazil's draft 
regulation.  His delegation was of the view that  no scientific evidence existed which proved a causal 
relationship between the use or patterns of t obacco smoking and the flavour and additives they 
contained; or that cigarettes with additives were mo re harmful or more attractive to youth than those 
which did not contain additives.  As such, Cuba wa s of the view that this measure was unlikely to 
contribute to decreased tobacco consumption in Brazil. 
48. While Cuba fully supported the objective of reducing the incidence of smoking habits among 
young people and the population in general, they were of the view that the regulation would 
unnecessarily restrict trade.  Additionally, he explai ned that his delegation was concerned that the 
regulation could create a precedent, leading other Members to establish their own lists of additive 
restrictions, in turn leading to uncertainty and unnecessary obstacles in terms of trade flows.  He 
suggested that Brazil consider adopting a less restric tive regulation, similar to other countries that had 
banned tobacco products highly flav oured with aromas.  This approach was preferable since the 
regulation was based on the performance of th e product rather than design and descriptive 
characteristics, as enshrined in Article 2.8 of the TBT Agreement. G/TBT/M/53 
Page 10  
 
  49. The representative of Colombia
 believed that Brazil's regulation violated Article 2.2 of the 
TBT Agreement.  He explained that while Colomb ia was ready to abide by the commitments it had 
made under the FCTC, discussions on questions of a dditives in tobacco products should be dealt with 
at the WHO.   
50. More specifically, he commented that Brazil's broad restrictions on tobacco products and 
additives would be detrimental to cigarette trad e, especially for Burley tobacco, which required 
additives to process this tobacco in to American blend cigarettes.  Th e representative claimed that the 
WTO was not the forum to discuss whether or not the measure would affect the smoking patterns of 
youth.  Regarding the broader objective of protecting public health, he claimed that no evidence existed showing that tobacco products containing add itives were more addictive.  He highlighted that 
Brazil had raised similar concerns over Canada's draft tobacco regulation at previous TBT Committee 
meetings, causing Colombia to question why Braz il was now going forward with its own similar 
legislation.  
51. His delegation was of the view that local t obacco producers in Brazil had influenced the 
adoption of this regulation.  According to 200 8 figures published by the Brazilian farming sector, 
Virginia tobacco represented 80 per cent of all Br azilian tobacco production, Burley tobacco 14.8 per 
cent, and others 5.4 per cent.  Because the measure would be easier to implement for Virginia tobacco 
producers, he expressed the view that the measure  would discriminate against those Members that 
produced other varieties of tobacco. 
52. The representative of the European Union
 stated that the proposed Brazilian measure would 
imply that exports of traditionally blended tobacco products to Brazil would have  to be discontinued.  
Moreover, it would affect exports of additives used  in tobacco products from the European Union.  
She confirmed that the European Union supported th e objective of protection of human health, which 
was in line with the WHO FCTC.  She noted that the European Union was itself in the process of 
revisiting its Tobacco Directive in order to implem ent the recommendations of the WHO and in this 
regard had some questions for Brazil. 
53. First, she asked for the background regarding Brazil's approach and reasons motivating the 
proposed ban on all additives, including sugars.  More over, she inquired as to the grounds justifying a 
ban on additives, rather than setting limits.  She asked whether Brazil had evaluated other legislative 
solutions, and whether it had carried out an assessment  to determine if these alternative solutions were 
less effective in decreasing smoking rates than the pr oposed approach.  She recalled that the Partial 
guidelines for implementation of Article 9 and 10  of the WHO FCTC recommended that Parties 
consider scientific evidence when determining new measures on ingredients. 
54. Second, she enquired as to whether Brazil had assess ed the impacts of the measure, including 
impacts on the consumption of tobacco products.  In particular, she asked if Brazil considered whether 
smokers might shift to other type of cigarettes that did not contain additives, such as Virginia tobacco.  
If an impact assessment had been carried out, she ask ed that its conclusions be shared with the 
Committee.   
55. Finally, she enquired about the timing for the adoption of the proposal, and whether it would 
be necessary to issue any implementing measures befo re these requirements could be put in force. 
56. The representative of Brazil  clarified some points regarding its National Health Surveillance 
Agency (ANVISA)'s Draft Resolution No. 112.  He stressed that the proposed technical regulation 
had been notified to the TBT Committee.  In add ition, a period of four months, ending 31 March 
2011, had been given to Members to make their co mments.  He confirmed that all comments received 
would be duly taken into account before th e final technical regulation was published.  G/TBT/M/53 
 Page 11 
 
 
  57. He confirmed that the objective of the meas ure was to protect public health through the 
reduction of cigarette attractiveness.  In response to  Mexico's claim, he noted that Brazil was an 
important producer and consumer of Burley tobacco , and that there was no reason to suggest any kind 
of discrimination in this measure.  He clarified that  there would be no requirement for this measure to 
be approved by the Brazilian Congress, as it was completely under the scope of ANVISA's 
competencies.  He also confirmed that the me asure had been based on the WHO FCTC and its 
implementing guidelines.   
58. With regard to the adequacy and necessity of th e proposed technical regulation, Brazil was of 
the view that the measure was adequate.  Since th e evaluation of the presence of aromas and flavours 
is subjective, previous attempts to prohibit th em without prohibiting additives had proven to be 
ineffective.  He also noted that the Brazilian G overnment had received indications that the tobacco 
industry had mastered the technology to process Bu rley tobacco without additives since 1996, thus 
leaving no grounds for allegations that prohibiting additives would de facto  prohibit Burley tobacco.  
In addition, he noted that some countries produced and sold blended cigarettes using Burley tobacco 
without the additives that this measure intended to prohibit. 
59. He informed the Committee that the Braz ilian regulatory authorities had information 
indicating that additives increased the effect of nico tine, thus making cigarettes more addictive.  Sugar 
for example, when burned, became a substance known as Acetaldehyde, which made cigarettes more 
addictive.  Additionally, some additives themselves were harmful to human health since when burnt 
they released carcinogenic substances.  He noted that  he had references to all of these studies and 
would be willing to share them with Members.  Finally, he expressed an openness to further discuss 
this issue bilaterally with interested delegations. 
(ii) Ecuador – Certification of Ceramic Tiles 
60. The representative of the European Union  expressed concern regarding the adoption and 
publication of Resolution 18 of the "Consejo Nacional  de la Calidad" (CONCAL), which laid out the 
documents that importers of cer amic tiles had to provide in order to obtain the Ecuadorian 
certification of conformity.  She noted that this regulation, adopted on 17 December 2010 brought 
substantial changes to Ecuador's  previous Resolution No. 10-2009.4  
61. She asked a number of questions, including:  why this regulation had not been notified 
according to Article 2.9.2 of the TBT Agreement; why supplier's declarations of conformity from 
enterprises that had been certified according to IS0 9001, and issued by a body recognized by the 
Ecuadorian Accreditation Body, were no longer accept ed; and confirmation that under Article 1 of the 
resolution, ISO 13006 certificates issued by bodies recognized by the Ecuadorian Accreditation Body 
would be accepted.  She noted that the European Un ion had been informed that only one laboratory in 
Ecuador had been accredited to carry out the tests, which could lead to bottlenecks for importers.  She 
invited Ecuador to take the appropriate steps to ensu re that an interruption in existing trade in ceramic 
tiles would be avoided. 
62. She also noted that the time during which existing certificates would be valid had been 
shortened from one year to 90 or 45 days.  Her de legation viewed this decision as arbitrary, and was 
particularly problematic for products that were alr eady certified but in the process of being imported.  
She asked Ecuador to consider extending these timelin es.  Finally, she regretted that her delegation 
had not been able to submit more detailed comments due to the fact that the Ecuadorian resolution had 
not been notified.  
                                                      
4 G/TBT/M/ECU/42 (Ecuador, 29 January 2009). G/TBT/M/53 
Page 12  
 
  63. The representative of Ecuador
 informed the TBT Committee that his delegation had taken 
note of the questions raised and would come back with answers at the next TBT Committee meeting. 
(iii) Brazil – Canned Sardines - Ministerial Act Nº 406, 10 August 2010 (G/TBT/N/BRA/386) 
64. The representative of Peru  raised concern about Brazil's draft technical regulation for the 
identity and quality requirements for canned sard ines.  She informed the Committee that her 
delegation's concerns were laid out  in detail in document G/TBT/W/334.5  She explained that for 
many years, exporters of Peruvian sardines ha d faced difficulties entering the Brazilian market.  
While Peru had tried to export the Engraulis  species of sardines to Brazil under denominations 
"Sardines X", Brazilian authorities had not allowed th e use of this denomination, in spite of their 
inclusion in Codex Stan 94 for tinned sardines.  This new regulation would make it even more 
difficult for the exporters of Peruvian sardines to enter the Brazilian market , as it would exclude from 
trade denominations "Sardines X".  Peru was of the view that this regulation contravened Articles 2.2 
and 2.4 of the TBT Agreement, a nd ignored Codex Stan 94 as a rele vant international standard.  
65. She explained to the Committee that Codex St an 94 listed 22 species from which sardines, 
canned sardines or other types of sardines could be prepared.  She expressed concerned that the 
Brazilian regulation moved away from Codex Sta n94, which permitted the use of the denomination 
"Sardines X" for tinned sandines from 21 of the 22  species listed under the international standard, 
including Engraulis Ringens .  Article 3 of Brazil's draft regulation excluded 14 of these species, 
including Enraulis Ringens , and Article 5 prohibited the products of the Engraulis Ringens  species 
from using the denomination "Sardines X".  The representative questioned why Brazil deviated from Codex Stan 94, or why it considered this internationa l standard inappropriate or inefficient to meet its 
objectives.  
66. Peru was of the view that this draft regula tion was incompatible with the TBT Agreement, 
since the Agreement specifi ed that international standards shoul d be used as the basis for technical 
regulations.  She stated that Codex Stan 94 was cons idered as an international standard and noted that 
many WTO Members, with heterogeneous consump tion patterns, e.g. EU, Canada, Colombia and 
Uruguay, followed the standard, making it possible for the Engraulis ringens  species to be used for 
the processing of tinned "Sardines X".  Moreover, the representative of Peru expressed concern that 
this regulation would have negative im plications for Peruvian exports of Engraulis ringens.  
67. She asked that Brazil align its regulation with Codex Stan 94, namely, accepting the 
denomination of "Sardines X" for Engraulis ringens.  Furthermore, she asked for clarification on 
Brazil's objective in putting in place this technical regulation, how it was justified under Articles 2.2 
and 2.4 of the TBT Agreement, when it would come  into force, and why Brazil had not applied Codex 
Stan 94. 
68. The representatives of the European Union
 and Norway , like Peru, were concerned that the 
Brazilian regulation significantly diverged from the in ternational standard for canned sardines, Codex 
Stan 94.  The representative of the European Union asked why Brazil had not aligned its measure with 
this standard, and requested an update on th e state of play of the draft regulation.  
69. The representative of Brazil  informed the Committee that the final version of its draft 
technical regulation on the quality and identity of sa rdines had not yet been published, and there was 
no forecast as to when the publication would take place.  All comments received during the public 
consultation, including those received from Peru afte r the deadline, would be taken into account.  He 
concluded that the Brazilian government was in th e process of analysing the comments, and that his 
delegation remained open to furthe r discuss the issue bilaterally. 
                                                      
5 G/TBT/W/334 (Peru, 15 March 2011).  G/TBT/M/53 
 Page 13 
 
 
  (iv) Colombia – Alcoholic beverages (G/TBT/N/COL/121 and Adds.1-3) 
70. The representative of the European Union  raised concern regarding Colombia's draft decree 
laying out requirements for the manufacture, pro cessing, packaging, marketing, sale, export and 
import of alcoholic beverages.  While the European  Union was pleased that some of their comments, 
which were submitted in the framework of the origin al notification, had been taken into account by 
the Colombian authorities, she noted that the re vised version of the draft still contained some 
provisions which could be problem atic, and which could have a significant impact on trade.   
71. In particular, she noted that some quality para meters, such as the restriction on the use of 
colouring, flavouring and sweeteners in liqueurs we re not in line with international practice.  
Additionally, her delegation was conc erned with the definitions of cer tain terms in the draft Decree, 
such as whiskey, vodka, rum, and gin.  
72. Regarding the labelling requirements specified in  the notified text, she asked whether it would 
be possible to place the stickers containing the ma ndatory labelling information locally, before the 
goods were placed on the market.  In addition, she ask ed if requirement to present a quality certificate 
at the time of the authorisation of the product applied also to locally produced goods.  Finally, she 
welcome the fact that Colombia had granted a suffi ciently long transitional period and asked whether 
existing stocks at the time of entry into force of the requirements would be subjected to the new 
regulation.  
73. The representative of the United States  requested that Colombia eliminate the three-year 
ageing requirement for whiskies, as contained in the latest version of the proposed regulation.  He 
noted that while certain types of whiskies might  be aged for specific periods, there were no 
internationally agreed maturation requirements.  He  explained that this was because the maturation 
process depended in large measure on the climate in which the maturation took place as well as the barrel technology used.  He asked for confirmation that mandatory reporting of the ageing time of 
rums would not be required and whether Colombia would permit the use of de minimus amounts of 
harmless colourings, flavourings and blending materi als for all categories of distilled spirits specified 
in the proposed measure.  
74. The representative of Colombia
 noted that the comment period for its notification 
G/TBT/N/COL/121/Add.2 had been extended until 4 Marc h 2011.  He explained that in light of the 
comments received, the competent authority consider ed it necessary to revise the draft regulation to 
ensure better compliance.  Finally, he confir med that comments received by Members would be 
analysed and that further information would be provided.   
(v) Korea – Good Manufacturing Practice requi rements for cosmetics (G/TBT/N/KOR/301) 
75. The representative of the European Union  expressed concern with Korea's Good 
Manufacturing Practice requirements for cosme tics (KCGMP), on which the EU had submitted 
comments on 8 March 2011.  While her delegation welcomed the fact that the draft regulation 
appeared to be in line with the relevant in ternational standard, ISO 22716 on Cosmetics Good 
Manufacturing Practice, she requested confirmation fro m Korea that this was the case.  If so, she 
asked Korea to explicitly refer to ISO 22716 in its  legislation;  otherwise she asked that any 
differences highlight between the KCGMP and the ISO standard be highlighted. 
76. Second, she noted that Article 30 of the dr aft regulation provided certain facilities for 
cosmetics manufacturers complying with the KCGMP – in particular, an exemption from the requirement of conducting batch test s and conducting quality management by lot number.  In this 
context, she asked whether forei gn cosmetic manufacturers could also  benefit from such derogation if 
they were recognised as complying with the KCGMP.  It was the EU's understanding that only G/TBT/M/53 
Page 14  
 
  domestic manufacturers would benefit from these de rogations.  If this was the case, she reminded 
Korea that the TBT Agreement prohibited discrimin ation between foreign and domestically produced 
products.  
77. Third, if the KCGMP requirements were very similar to those of ISO 22716, she asked 
whether Korea's responsible authority, the Korea Food and Drug Administration (KFDA), would 
recognize assessments performed or certificates issu ed by testing laboratories or governmental 
agencies of third countries proving compliance with ISO 22716.  
78. Finally, she expressed doubts as to whether the Korean Cosmetic Association (KCA), which 
in her understanding was the only body authorized to conduct an evaluation of KCGMP compliance, 
was sufficiently impartial and neutral to conduct unbiased assessments of both foreign and domestic 
cosmetics manufacturers.  She noted that Korea could avoid potential bias in this context by 
recognizing foreign inspections and certificates, for example.  
79. The representative of Korea
 clarified that Korea's draft regulation on Cosmetics - Good 
Manufacturing Practice, put forth by the Korea F ood and Drug Administration (KFDA), was part of 
an effort to harmonize with the international standa rd ISO 22716.  This effort sought to improve the 
quality of cosmetics and to protect public health  from hazardous cosmetics.  Hence, the regulation 
proposed by the KFDA had been largely based on ISO 22716.  He explained that the KCGMP was 
voluntary, and there were no plans to make the regul ation mandatory.  Furthermore, he noted that the 
agency responsible was the KFDA and not the KCA.   
80. Regarding the exemption provisions for manufactu rers that complied with the requirement, he 
confirmed that there was preferential treatment to domestic manufacturers.  However, he clarified that 
importers of non-Korea manufacturers' cosmetics products could also receive similar preferential 
treatment, such as exemption from quality inspection, if the non-Ko rea manufacturers passed the on-
site inspection under Article 9 of the Department Or dinance of Cosmetics.  He explained that this 
order had been running for more than 10 year s and that 23 importers of foreign cosmetic 
manufacturers to date had passed the on-site insp ection and enjoyed the benefits.  He recommended 
that the European Union discuss bilaterally with  Korea and try to sign an MOU with the KFDA. 
(vi) Ukraine – Draft Technical Regulation on th e labelling of foodstuff (G/TBT/N/UKR/52 and 
Add.1) 
81. The representative of the European Union  expressed concern that several provisions of 
Ukraine’s Draft Technical Regulation on the labe lling of foodstuff (G/TBT/N/UKR/52), notified in 
January 2011, differed from the Codex Alimentarius and appeared to be costly and burdensome for 
operators.  She noted that her delegation had recently submitted detailed comments on this draft 
regulation.   
82. The representative recalled her delegati on’s comments on a previous notification 
(G/TBT/N/UKR/45) related to GMOs, and Ukra ine’s commitment to amend its GMO labelling 
provisions.  In particular, Ukraine had agreed that  only foodstuffs containing more than 0.9 per cent 
GMOs would have to be labelled with the inscriptio n 'with GMO';  there would be no obligation to 
label other products with the inscription 'GMO fre e'.  Furthermore, she inquired on which grounds 
Ukrainian authorities had prohibited health clai ms, whereas the Codex Alimentarius allows and 
provides guidelines for those claims.  
83. Finally, the representative requested that Ukra ine authorities review and clarify requirements 
for mandatory origin labelling, since as currently formulated, the requirements seemed to apply only 
to imported products.  She also recommended that the definitions of products such as: spread, blended 
fats, starch and glucose syrup be rendere d consistent with Codex Alimentarius.  G/TBT/M/53 
 Page 15 
 
 
  84. The representative of the Ukraine  noted that while the period for comments on 
G/TBT/N/UKR/52 closed 1 March 2011, her dele gation was still willing to address concerns of 
Members.  She explained that the technical regul ation in questions further harmonized Ukrainian 
regulations with EU directives and internationa l requirements, including with respect to GMO 
labelling.  A grace period of 9 months was envisaged by Ukraine to enable businesses to smoothly 
adapt their operations to the new rule.  She reporte d that answers to all the questions received from the 
European Union had been prepared.  They were in  the process of being translated by capital, and 
would subsequently be provided to the European Union. 
(vii) China – Requirements for information security products, including, inter alia, the Office of 
State Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial 
encryption products and its on-going revision an d the Multi-Level Protection Scheme (MLPS) 
85. The representative of the European Union  explained that the title of the specific trade concern 
reflected the broad scope of his delegation’s concer ns in this context, some of which had been 
previously raised.  He thanked China for mainta ining an open channel of communication with the 
European Union on these issues, and indicated that his intervention woul d firstly focus on the revision 
of the 1999 Regulation on Commercial Encryptio n Code by the Office of the State Commercial 
Cryptography Administration (OSCCA).  In this regard, he expressed his delegation’s hope that the on-going revision of the Re gulation would effectively address the concerns raised by the European 
Union and its industry.  This required, inter alia , a clarification of the product scope and definitions, 
the removal of the current restrictions on approva ls of encryption products incorporating foreign 
technology, and the introduction of  certification procedures that duly address the legitimate concerns 
of foreign encryption product manufacturers rega rding the protection of their intellectual property 
rights, including requirements for source code disclosur e.  In addition, he sought clarification as to the 
relationship between the OSCCA regulation and other regulations in the area of information security, 
namely the Compulsory Certification scheme for Information Security Products (CC-IS), managed by 
the National Certification and Accreditation Admi nistration of China (CNCA), and the Multi-Level 
Protection Scheme (MLPS) under the leadership of the Ministry of Public Security (MPS).  The 
representative requested an update as to the expect ed timeline of the revision process and when a 
public consultation would be held, and also requested  that the draft measure be notified to the TBT 
Committee at the earliest appropriate stage so as to provide interested Members with an opportunity to 
comment.  
86. The representative of the European Union also expressed concern with regard to the overall 
opacity of the implementation process of the MLPS.  The lack of transparency  created an uncertain 
and unpredictable business environment for foreig n ICT equipment manufacturers operating in the 
Chinese market.  He requested a general update on the implementation of the MLPS, including which 
sectors were being prioritized for assessment, and on the classification of those IT systems which had 
already been assessed in a ccordance with the MLPS criteria.  In addition, the representative reiterated 
his delegation's substantive concer ns regarding the application of the MLPS in sectors with no 
obvious relevance to national security, and also the risk of a back door application of the CC-IS 
requirements through the MLPS for commercial products not covered by its scope.  He noted that the 
CC-IS was currently limited de jure  to government procurement, yet there was evidence that 
compliance with CC-IS was required by several la rge state-owned enterprises, for instance in the 
banking sector, as a condition for procuring smartcards. 
87. Finally, the representative expressed the belief th at there was unexplored potential for closer 
cooperation between Chinese and other WTO Memb ers, and the global ICT industry in the 
information security field.  Therefore, his dele gation would continue to seek a more comprehensive 
dialogue with competent Chinese authorities, and he hoped to report some progress in this regard at 
future meetings.  G/TBT/M/53 
Page 16  
 
  88. The representative of Japan
 expressed support for the EU position, and reiterated that the 
various schemes and regulations with in China regarding information security were not in conformity 
with global norms and approaches.  His delegation was concerned with the negative affect that these 
measures could impose on trade in information security  products.  He recalle d that delegations had 
asked China to be prudent in introducing measures re garding information security.  He informed the 
Committee that China was currently  considering a new certification scheme for information products 
that were not subject to the current CC-IS schem e, and he requested that China provide necessary 
information regarding the scheme, including its purpose. 
89. The representative of the United States  echoed the request of the EU delegate that China 
notify any proposed revisions to OSCCA regulations  on commercial encryption so that Members and 
other interested parties may provide comments.  He  warned that if the planned revision expanded the 
scope of the regulations to more information or technology products (for example, by modifying or 
eliminating the core-function test) the impact w ould be felt across a broad range of the global 
information technology sector.  In particular, trad e disruption could result, such as occurred in 1999 
when China issued the first version of these regul ations; which was eventually limited in scope to 
products whose core function is encryption.  Fu rthermore, expansion of the scope could raise 
questions as to whether the measure was more tr ade restrictive than necessary, and his delegation 
would continue to monitor this issue. 
90. The representative of Korea  shared the concerns raised by the European Union, Japan, and the 
United States. 
91. The representative of China  explained that the revision of the commercial cryptography 
regulation by the Office of the State Commercial Cryptography Administration (OSCCA) was on the 
agenda of the legislation plan of the State C ouncil for 2011.  Based on scientific verification and 
public input, OSCCA was revising the measure under the Legislation Law and the Procedures of the 
Formulation of Administrative Regulations. 
92. He informed the Committee that the correct name of the measure referred to by other 
delegations in the context of the MLPS was the Re gulation on Classified Protection of Information 
Security (RCPIS), a basic information security re gulation following Chinese laws and regulations, and 
implemented by a series of standards and management specifications.  He noted that in practice, there was no evidence that the implementation of RCPIS ha d affected the stability of the information and 
communication equipment market. 
93. The representative explained that five levels of  information security protection systems were 
stipulated in RCPIS, amongst which Level III and above involved syst ems concerning critical 
infrastructure and important assets.  These critical infrastructure and important assets were vital to maintain and safeguard national secu rity and public interest in fi elds such as government organs, 
finance, and banking.  He stated that Level III and above covered only a limited scope amongst all 
information systems employed in China.  He obser ved that only a small percentage of information 
systems in major industries would be covered by Level III and above.  His delegation believed that 
RCPIS would impose a limited impact upon major industr ies, similar to the impact of EU information 
security regulations on the banking sector. 
94. He reported that his delegation had held on the previous day, a bilateral meeting with the 
Japanese delegation, and that he wanted to continue to work to clarify what global norms were in the 
information security sector.  Also, the representa tive stated a preference for close cooperation and 
dialogue in the future as suggested by the EU delegation. 
95. In light of the information provided, th e representative of the European Union
 asked at what 
stage in the process of the revision of the OSCCA regulation the measure w ould be notified to the  G/TBT/M/53 
 Page 17 
 
 
  TBT Committee.  Also, he asked what modalities were being used to seek public input on this 
measure, and whether there would be  an open call for public comments. 
96. The representative of China  replied that the he could not gi ve a concrete timeframe for the 
TBT notification and the public hearing because th e measure was still undergoing an internal research 
process.  However, he pledged to keep bilateral contact with EU colleagues open on this issue to 
achieving a mutually satisfactory result. 
(viii) China – Lighting and Light-Signalling Devi ces for Motorcycles (G/TBT/N/CHN/721 and 
Suppl.1) 
97. The representative of the European Union  stated that in November 2010 China had clarified 
that motorcycles equipped with automatic headlamps and daytime running lights could not be 
accepted in China.  However, she informed the Committee that China had replied the day before to 
the EU in writing that it agreed that automatic headlamps and daytime running lights could contribute to world safety and that China was monitoring the EU  experience in order to decide if motorcycles 
equipped with these devices would be admitted in China.  The representative underlined her delegation’s interest in exchanging information with  China so to avoid motor vehicles equipped with 
automatic headlamps and daytime running lights, whic h were in compliance with the relevant United 
Nations Economic Commission for Europe (UNECE) regulations, having to be redesigned for the 
Chinese market alone. 
98. The representative of China
 replied that the measure in question specified the technical 
requirements, test method and inspection rules fo r the installation of lighting and light-signalling 
devices for two wheeled motorcycles.  He reported that the draft standard had been notified on 8 
February 2010, followed by a sixty-day comment pe riod, and that the European Union had submitted 
three sets of written comments to China's TBT enquiry point, on 30 April 2010, 8 November 2010 and 11 March 2011.  He noted that his delegation rep lied to all three sets of comments, and he hoped 
the replies addressed most of the concerns raised by the European Union.  He was glad that the 
European Union was satisfied with  his delegation’s latest reply.  His delegation remained open for 
further technical contact with through TBT enquiry  points, as well as other bilateral channels.  
Finally, he informed the Committee that the standa rd had been approved and published on 10 January 
2011 and would be implemented on 1 January 2012. 
(ix) China – Provisions for the Administrati on of Cosmetics Application Acceptance 
(G/TBT/N/CHN/730 and Suppl.1) 
99. The representative of the European Union
 raised concerns with regard to Decree No. 856 
issued by the State Food and Drug Administration of China (SFDA), on the "Application and 
Acceptance of Administrative Licensing for Cosmetics".  She stated that this Decree had been issued 
on 25 December 2009, and had been notified to the TBT Committee on 25 March 2010, just 5 days before its entry into force on 1 April 2010.  The representative explained that neither European 
industry nor EU authorities had had an adequate opportunity to co mment on the draft legislation, 
which was required according to China's transpar ency obligations under the TBT Agreement.  
Furthermore, she noted that industry had been gi ven only three months to comply with the new 
regulatory requirements. 
100. The representative reported that, following the en try into force of the new requirements, 
approvals of new cosmetic produc ts in China had decreased from around 1000 per month to a nearly 
complete standstill.  However, she noted that in the past few months the situation seemed to have 
somewhat improved, with some 370 products reportedly approved betw een November 2010 and 
February 2011.  Nevertheless, EU industry still expe rienced significant delays in their application for 
new product registrations, and the average number  of products approved per month under the new G/TBT/M/53 
Page 18  
 
  requirements was only a fraction of what it used to be under the previous notification system. 
Furthermore, she suggested that the legislati on discriminated between domestic and foreign non-
functional cosmetics;  while the latter were s ubject to registration as a pre-condition for their 
placement on the market, the former would apparently  be subject to a notification requirement only, 
which could be submitted even after their placement on the market.  
101. She expressed appreciation for China's efforts to  put in place an efficient and comprehensive 
regulatory system for the approval of cosmetics.  She reported that the European Commission had 
discussed the issue of the new cosmetics licensing re gime at expert level with the SFDA on several 
occasions, most recently during an expert meeting he ld in January 2011.  Her delegation was grateful 
for SFDA's openness to discus with EU experts, as we ll as its efforts to clarify and streamline the new 
requirements – as exemplified by the issuance of th e Guidelines on 'Key Points for Technical Review' 
of October 2010, which had helped shed light on several issues.  Furthermore, her delegation 
welcomed recent progress by the SFDA in addr essing the backlog of applications for product 
registration. 
102. Despite this evident progress, the representativ e expressed concerned with the slower pace of 
the new product approvals as compared to the previo us system, that had caused serious delays for the 
placement of European products on the Chinese ma rket, and had disrupted production and marketing 
plans for those products.  The uncertainty confro nting foreign manufacturers was further compounded 
by the lack of clarity of the new ru les in several respects.  For instan ce, she explained that with regard 
to the registration of new ingredients, there wa s still uncertainty as to the definition of 'new 
ingredients'.  The representative recalled that in December 2010, the SFDA had issued draft 
guidelines defining 'new ingredients' as 'any ingred ients used for the first time in cosmetics on the 
market in China'.  Nevertheless, she noted that th e draft guidelines did not contain a list of existing 
ingredients, and industry had so far not been consulte d in order to ensure that such a list was correct 
and complete.  The representative therefore urged Ch ina to develop a comprehensive and accurate list 
of existing ingredients, in consultation with both concerned foreign and domestic industry. 
103. More generally, she noted that there had been a great number of rules applicable to cosmetics 
adopted by the SFDA in recent times.  The speed at which these requirements were issued, and the 
often short period given to companies to comply, were posing considerable difficulties to industry 
exporting cosmetics to China.  Her delegation ur ged the SFDA to adhere to principles of good 
regulatory practice – for example, through a t horough regulatory impact assessment and public 
consultation, as well as notification of TBT-relate d measures to the TBT Committee while measures 
were still in draft stage, and comments could still be taken into account.  Finally, she asked that 
comprehensive guidance for implementation of all ne w rules be provided, so to allow industry to 
comply with the requirements.  
104. Finally, she reported that her delegation had lear nt that the SFDA had issued a new rule (no. 
454 of 26 November 2010) specifying further requirements for cosmetics products.  This rule would 
enter into force on 1 April 2011, but had not yet been notified to the TBT Committee.  She reported 
that the regulation included several requirements, inter alia , on testing for product stability or shelf 
life, which could be problematic for EU industry.  She therefore requested that  China notify the latest 
rule, and suspend its entry into force pending notif ication, to ensure that Member’s comments are 
taken into account. 
105. The representative of China
 explained that the SFDA revised and issued the Provisions for the 
Administration of Cosmetics Application Acceptance in response to safety problem that emerged with 
cosmetics, in particular with child bathroom pr oducts and talcum powder in  2009.  He noted that 
during the revision process the SFDA had held fo rums, workshops, and expert discussions with 
enterprise representatives, as well as solicited public  opinion including those from the European  G/TBT/M/53 
 Page 19 
 
 
  Chamber of Commerce and several European enterp rises, and had taken all those comments into 
account. 
106. He stated that in order to strengthen supervis ion on cosmetic materials, the measure required 
that enterprises submit safety evaluation data on potentially harmful substances.  Based on risk 
assessment and taking into account comments from th e European Chamber of Commerce, L'Oreal, 
P&G, Johnson&Johnson, Unilever,  and Chanel, the SFDA had issued the Guidance on Safety 
Assessment of Potentially Harmful Substance in Cosmetics on 23 August 2010.  He noted that this 
guidance was in line with the 6th Revision of the Notes of Guidance for the Testing of Cosmetic 
Ingredients and their Safety Evaluation by EU Scientific Committee on Consumer Products.  The 
representative pointed out that the SFDA guidance ha d clearly defined potentially risky substances in 
cosmetics, basic procedures for safety evaluation,  requirements on evaluati on data (and the relevant 
submission form), and data review principles. 
107. In addition, he informed the Committee that SFDA had issued documents outlining key points 
and guidance for the technical review of cosmetics.   Meanwhile, the representative noted that fruitful 
training had been carried out for cosmetics enterp rises, including those from the European Chamber 
of Commerce.  He reported that cosmetic regist ration and recording was proceeding smoothly, and 
qualified products, including those from EU cosmetic  producers, had been recorded and approved.  
With respect to the new SFDA rule flagged by the European Union delegate, he promised to deliver 
comments to the SFDA. Finally, he agreed to  follow up on a letter from the European Union 
delegation suggesting a July 2011 meeting between SFDA and the European Commission in Brussels. 
(x) China -– Administration on the Control of Pollution Caused by Electrical and Electronic 
Products (G/TBT/N/CHN/140, Add.1 and Rev.1) 
108. The representative of the European Union  welcomed the objective of reducing environmental 
pollution caused by electric and electronic products w aste, as pursued by the notified document.  She 
reminded the Committee that the European Union main tained legislation on the restriction of the use 
of certain hazardous substances in electrical a nd electronic equipment, and the European Union 
pursued the same objectives as China of protecting the environment and human health. 
109. However, the representative expressed concer ns about the uncertainty that the notified 
document introduced around the certification procedure that would be introduced for electrical and electronic equipment.  First, she observed that th e notified draft foresaw the future creation of a 
catalogue of products that were requi red to meet the requirements.  It was unclear when and according 
to which criteria the catalogue would be set up.  Therefore, the representative requested confirmation 
from China that the introduction of products in the future catalogue would be notified to WTO 
Members under the TBT Agreement, and that an appropriate time for comments would be given. 
110. Secondly, she stated that her delegation unders tood that the notified draft required that the 
products introduced in the future catalogue would need  to be certified according to a system endorsed 
by the State.  The representative questioned why such a third party certification was necessary for 
proving compliance with the restrictions on the use of certain hazardous substances in electrical and 
electronic equipment.  She explained that the ri sk that the requirements aimed to control only 
appeared when the products entered the waste phase,  and were not present in the consumer use phase.  
She therefore considered this third party pre-ma rket certification to be an overly burdensome 
requirement that constituted an unnecessary obstacle to  trade according to Article 5.1.2 of the TBT 
Agreement.  A system of supplier’s declaration of conformity (SDoC), c oupled with post-market 
surveillance would, in the view of the representa tive, be a more proportionate option, and would 
achieve China’s objective of reducing pollution without placing unnecessary burdens on economic operators.  She recalled that similar European Uni on legislation called only for a supplier's declaration 
of conformity.  Her delegation therefore invited Chin a to reconsider the requirement of a third party G/TBT/M/53 
Page 20  
 
  certification, especially since her delegation was aware that a voluntary certification scheme for six 
products was already under development in China.  Finally, based on the written reply of China dated 
2 March 2011 to her delegation’s written comments,  she understood that China was still considering 
certification options, and she sought confirmation of this point. 
111. The representative of Japan
 supported the concerns raised by the European Union.  He 
expressed appreciation for China’s reply to comments made by the Japanese government on 
notification G/TBT/N/CHN/140/Rev.1, however, he  sought additional information on a number of 
points.  First, with regard to the national certifi cation system for the control of pollution caused by 
electronic products (stipulated by Article 21), the representative inquired whether mandatory third party conformity assessment, voluntary  supplier's declaration of conformity certification, or other 
kinds of certification would be used to demonstrate compliance with the regulation.  In particular, he 
sought to confirmation that a voluntary Supplier's De claration of Conformity (SDoC) could be used. 
112. Second, the representative noted that Article 3( 1) of the draft regulation stipulated that 
"electrical and electronic products refer to equipmen t and related products".  He therefore suggested 
that objective related products, as well as excluded produc ts, be listed in a separate list or Annex.  He 
highlighted automobiles, batteries, any parts and ma terials incorporated in "equipment and attached 
products", any jig tool (e.g., a die), and materials used in production of "equipment and attached 
products" as products that needed to be excluded und er the definition of the electrical and electronic 
products. 
113. The representative of China
 stated that the measure in question (Administration of the Control 
of Pollution Caused by Electrical and Electronic Products) was notified on 21 October 2010, and that 
his delegation had received comments from the United  States, EU, and Japan; replies were provided 
through the TBT enquiry point earlier in March 2011.   Given the concerns expressed by China’s trade 
partners, he saw a need to provide further clarification.   
114. He explained that the management catalogue for the Control of Pollution Caused by Electrical 
and Electronic Products was presently being drafted,  and would be notified to the TBT Committee in 
due course.  The representative also stated that mand atory, voluntary, or other kinds of certification 
could be employed for the purposes of conformity assessment.  These options ensured non-discrimination under the requirements for both domes tic and imported products.  The representative 
also noted that the Chinese government would honour MRAs reached between China and other 
countries.  Related standards and the procedures of  conformity assessment would be developed in line 
with WTO rules and international practice.  He informed the Committee that at present only six 
hazardous substances, including lead, mercury, were li mited in electrical and electronic products.  The 
representative assured the Committee that any chang es to the prohibitions of hazardous substances 
would be notified to the WTO TBT Committee. 
(xi) India – Food Safety and Standards Regul ation - Food labelling requirements 
(G/SPS/N/IND/69) 
115. The representative of the European Union
 stated that India had notified a draft regulation on 
food safety and standards to the SPS Committee (G/SPS/ N/IND/69) in July 2010.  In comments to the 
SPS notification, her delegation noted several trade r estrictive aspects of the regulation, as well as 
deviations from Codex Alimentarius .  In addition, her delegation observed that the Indian regulation 
included TBT related aspects, such as labelling a nd packaging requirements, and consequently, she 
asked that India also notify the regulation to the TBT Committee.  She explained that a number of the 
Indian packaging and labelling requirements coul d be considered burde nsome and more trade 
restrictive than necessary.  For in stance, the obligation to label certain aspects in capital letters 
appeared to be too strict and went beyond practice of Codex Alimentarius.  In this context, her  G/TBT/M/53 
 Page 21 
 
 
  delegation requested an opportunity to discuss these aspects in detail with India, and therefore kindly 
reminded India of the need to notify the text to the TBT Committee. 
116. The representative of the United States  agreed with the EU position that this measure should 
be notified to the TBT Committee.  He noted that, for example, Chapter 4 dealt with packaging and 
labelling regulation requirements, a nd Chapter 5 set out identity standards for various milk and cheese 
products, and his delegation believed it to be ap propriate to notify this measure to the TBT 
Committee. 
117. The representative of the United States  clarified that there were some elements of the 
requirements that could have both SPS and TBT compone nts.  For instance, he observed that Chapter 
4 of the proposal also contained elements relate d to nutritional labelling, and Chapter 5 contained 
elements related to different types of quality and identity ingredient issues with respect to various 
cheese, whey, and milk products.  His delegation did not view these as food safety issues, rather as 
quality and nutritional issues.  Therefore, the me asure should be notified both to the SPS and TBT 
Committees, and he agreed to provide further el aboration at the United States – India bilateral 
meetings later in the week. 
118. The representative of the United States  clarified that there were some elements of the 
requirements that could have both SPS and TBT compone nts.  For instance, he observed that Chapter 
4 of the proposal also contained elements relate d to nutritional labelling, and Chapter 5 contained 
elements related to different types of quality and identity ingredient issues with respect to various 
cheese, whey, and milk products.  His delegation did not view these as food safety issues, rather as 
quality and nutritional issues.  Therefore, the me asure should be notified both to the SPS and TBT 
Committees, and he agreed to provide further el aboration at the United States – India bilateral 
meetings later in the week 
119. The representative of India  believed that the objectives of the measure were well ensconced 
within relevant paragraphs  contained in Annex A.1(b) of the SPS Agreement. 
(xii) Brazil – Disposition (Portaria) nº 371, D ecember 29th 2009 and Annex; INMETRO approves 
Conformity Assessment Requirements for Security of Electronic Appliances 
(G/TBT/N/BRA/343 and Add.1) 
120. The representative of Mexico  referred to conformity assessment issues for electronic and 
other domestic items related to Brazil’s notificati on G/TBT/N/BRA/343/Add.1.  He first stated that 
Mexico shared Brazil's legitimate objective of ensuring consumer safety through conformity 
assessment.  The original notification of this me asure was made on 4 September 2009, which stated 
that public consultations would be held by INMETRO related to the conformity assessment 
procedures for security and safety of electronic appliances.   
121. The representative explained that the second a nd final conformity assessment requirements 
were laid out in government provision 371 of Dece mber 2009, published in the Official Journal on 31 
December 2009, as notified in G/TBT/N/BRA/343/Add.1.   A transition period was also established: 
as of 1 July 2011, all household manufactured appliances would have to comply with the provisions; 
as of July 2012, market entry for all appliances would be conditional on meeting the requirements; 
and, as of January 2013, the marketing of these goods would have to occur in accordance with 
relevant provisions of the new conformity assessment requirements. 
122. He noted that there was a compulsory certifica tion process for this type of appliance that had 
to be carried out by an INMETRO accredited cer tification body.  The mechanism for conformity 
assessment would be mandatory certification of the importing producer, thus permitting use of the 
seal of compliance.  The representative explaine d that the seal of compliance was designed to G/TBT/M/53 
Page 22  
 
  communicate the level of confidence in product c onformity with relevant product standards, 
according to the legal provision of Brazil.  He noted that the seal must be granted by a certification authority, and must be marked both on the labelling and the packaging, and be visible and readable. 
Furthermore, it must be buttressed by a system of redress for consumer concerns or complaints.  Two types of authorization were envisaged for use the seal: certification with evidence; and evaluation of 
the quality certification through inspection.  The fo rmer involved an extensive process of gathering 
evidence, evaluating product quality, and produc tion processes, including special evaluations in 
certain cases.  The latter involved certification pe r batch of products, through inspection on a per need 
basis. 
123. The representative of Mexico recognized the right of Brazil to implement conformity 
assessment requirements that it deemed appropriate.  However, in this particular case he was 
concerned about the excessive and unjustified co st imposed on Mexico’s export industries by 
mandatory compliance.  Therefore, he hoped that a lternatives could be found to facilitate bilateral 
trade of these products, which would guarantee their security and safety, yet be less cumbersome and 
difficult for countries concerned. 
124. The representative requested that Brazil provide information as to the possibility of creating 
mutual recognition agreements for the conformity of  such products, and whether they were envisaging 
accreditation of exiting conformity assessment bodies in  other countries in this context.  He asked 
what considerations led Brazil to demand mandatory ce rtification and use of the seal of conformity for 
these products.  He also sought information on the deadlines and timeframes re quired to obtain these 
certifications, and whether the necessary infrastruct ure existed in order not to create unnecessary 
barriers to trade through delays.  Finally, the repr esentative inquired as to whether Brazil envisaged 
extending the scheme to other products beyond domestic electrical appliances. 
125. The representative of Brazil
 explained that Ministerial Act No.371 of 29 December 2009 was 
notified to TBT Committee through document G/TBT/N/BRA/343 and G/TBT/N/BRA/343/Add.1.  The act was published after a public consultation pr ocess, which was initiated six months before the 
publication of the final technical regulation.  He st ated that compliance with the requirements of the 
regulation would become mandatory in July 20 11, July 2012 and January 2013, depending on the 
goods concerned.  Members therefore had reasonable time to participate in the regulatory process, and to adapt to the new requirements. 
126. The representative responded that the decision for mandatory certification was based on the 
assessment of the risks posed by these products.  He  noted that the objective of the measure was to 
ensure the safety of electrical appliances commerciali zed in Brazil, and that the regulation was applied 
without discrimination between domestic and fore ign products.  Furthermore, the regulation was 
based on relevant IEC standards for household el ectrical appliances.  The representative explained 
that foreign bodies could perform the certification,  provided that those bodies met the requirements 
laid out in Article 13 of the regulation.  With re gard to MRAs, he stated that Brazilian regulatory 
authorities examined the adequacy of negotiating such instruments on a case-by-case basis.  Finally, 
with respect to extending compulsory certification to  other sectors, he clarified that the need to 
establish mandatory certification depended on assess ments performed by regulatory authorities, 
especially related to the risks posed by products, a nd any future decisions related to certification 
would follow this principle. 
(xiii) United States – Food Safety Modernization (FSMA) Public Law 111-353 
127. The representative of Mexico
 stated that the Congress of the United States had approved the 
Food Safety Modernization Public Law in January  2011, and that the promulgation provided for 
major changes in the areas of production, transporta tion, distribution and import of food products into 
the United States.  He explained that the law calle d for the regulatory activities of the United States  G/TBT/M/53 
 Page 23 
 
 
  Food and Drug Administration (FDA) to be preventiv e in nature, rather than reactive.  These 
regulatory activities covered the totality of the food production chain, from the farm all the way to the 
point of sale.  Furthermore, he noted that th e law involved twelve new regulatory measures, and 
strengthened the capacity of the FDA for the effec tive supervision of the entire food production chain 
through inspection, including of both domestic and imported food.  This covered the gathering of 
records of all involved establishments, and the re gistration of these establishments with the FDA 
when they were part of the food production chain.   This registration had to be updated every 
two years, and the representative explained that establishments could be suspended if the FDA 
suspected that the products of an establishment coul d be a cause of damaged health or could a pose a 
risk to health.  Additionally, wr itten reports would be made.  The representative noted that some 
imported food would have to obtain certification to guarantee entry into the United States market, and 
in some cases exporters as well as importers would n eed to obtain certification.  He said that the law 
provided an obligation for traceability of imported products and also permitted the administrative 
seizing of products if the FDA believed that some f ood products had been adulterated or incorrectly 
labelled.   
128. His delegation shared the concern of the United States for the protection of human health, and 
recognized the impact that food safety could have on human health; and, Mexico was making efforts 
in order to attain this objective as well.  Howe ver, the representative expressed concerns about the 
possible lack of coherence of this law with the obligations of the United States under Articles 2.2, 2.9, 2.9.4 of the TBT Agreement, amongst others.  First,  he was concerned that the measure had not been 
notified nor had time been provided for comments.  Some provisions of the aforementioned law could 
have implication with regard to the commitments of the United States with respect to both the TBT 
and SPS Agreements, in particular specifications that  could be subject to the definition of technical 
regulations or measure, respectively laid out in Annex 1.1 of the TBT Agreement and/or Annex A.1 
of the SPS Agreement.  Therefore, the representa tive believed that the United States was obliged to 
comply with transparency obligations contained in both Agreements.  Moreover, he expressed the 
view that the measure was excessively restrictive because in his delegation’s view, there were other 
ways of achieving the United States’ objectives wit hout unnecessarily restricting trade.  For example, 
Section 207 of the law specified that if the FDA su spected that a food product had been adulterated or 
improperly labelled, it could lead to the administrative seizure of that product. 
129. The representative called on the United States to ensure that the implementing regulations of 
the law undergo a public consultation and be no tified to the TBT Committee.  Moreover, he 
highlighted the importance of avoiding any impedime nts in the flow of food trade between Mexico 
and the United States, in order to ensure due process in the implementation and entry into force of the 
law.  He reiterated Mexico’s commitment to establishing measures providing for food safety, yet he 
underscored the need to do so in a way that resp ected international obligations and ensured that 
measures were least trade restrictive as possible.  Finally, he inquired whether the United States 
envisaged including within the law’s implementa tion provisions aspects pertaining to special and 
differential treatment and technical assistance for developing countries.  
130. The representative of the United States
 stated his delegation’s view that this measure fell 
squarely within the SPS realm, and it therefore was not appropriate to discuss its contents in the TBT 
Committee.  He understood that Mexico was con cerned that there could be some potential TBT 
elements in the law’s forthcoming implementing regulations, to be issued by the FDA.  The 
representative pledged to review these regulations from the TBT perspective, and should there be any 
TBT elements, they would be notified to the Comm ittee.  He reported that Mexico and the United 
States had held bilateral discussions on this issue earli er in the week, and he ur ged Mexico to continue 
discussion of this issue with the United States’ SPS experts. G/TBT/M/53 
Page 24  
 
  (xiv) China – The Provisions on the Environmental Administration of New Chemical Substances 
(Amendments) (G/TBT/N/CHN/210/Rev.1) 
131. The representative of Japan
 welcomed the movement forward on the environmental 
administration of chemical substances, since they demonstrated that the People's Republic of China's 
was moving towards harmonization with international st andards in terms of accepting data obtained in 
accordance with OECD test guidelines.  In particular , this shift was evident in the guidelines for new 
chemical substances, and the registration of me asures on the environmental management of new 
chemical substances.  However, the representative noted that China required test data obtained by 
Chinese testing bodies pursuant to Article 10-(3) of the Measures, and to Article 4 requirements for 
chemical substance notification doc uments and requirements for notifi cation data.  He requested that 
China amend inconsistencies with international st andards, and that China revise clauses of the 
guidance documents. 
132. The representative of the European Union  shared the concerns of Japan as to the fact that the 
Chinese measures on environmental management of ne w chemical substances required that data for 
certain eco-toxicological tests be generated by Chin ese laboratories.  Her delegation considered this 
requirement to be more strict than necessary, sin ce tests in accordance with  available test methods 
adopted by the OECD, and performed according to Go od Laboratory Practices, could be carried out in 
laboratories outside China in the same way as in Chin ese laboratories.  This applied equally to tests 
for degradation and fish toxicity.  She therefor e urged China to amend the measure so that eco-
toxicological tests carried out according to the OE CD test guidelines in laboratories outside China 
would be recognized, including those for degradation and fish toxicity. 
133. Furthermore, the European Union sought clarifi cation as to the distinction between "general 
chemical substances" and "hazardous chemical substan ces" as foreseen in Article 50 of the measure.  
This distinction seemed to be made on the basis of the UN Globally Harmonized System of Classification and Labelling of Chemicals; however, she noted that her dele gation could not find any 
confirmation to this respect in the implementation guidelines.  She requested that China confirm that 
the distinction between types of chemical substa nces was based on the Globally Harmonized System, 
in compliance with Article 2.4 of the TBT Agreement.   If the distinction was not based on this system, 
she asked for justifications as to wh y this relevant international sta ndard in the area of chemicals had 
not been followed. 
134. The representative of China
 said that his delegation had he ld a bilateral meeting on the 
previous day with Japan concerning measures on environmental management of new chemical 
substances, and that Japan had expressed a need for fu rther clarification.  He therefore explained that 
the registration requirement and legislation target of  the measures were similar to those in the OECD 
requirements.  However, he noted that different ta rget organisms in the different environments of 
different countries generated different data on the same  chemical substances; this was in fact the case 
with eco-toxicological testing data obtained by t esting facilities within Chinese territory.  However, 
China was currently participating in mutual data  recognition activities in OECD.  The representative 
further explained that 27 related national standards were being form ulated in accordance with this UN 
globally harmonized classification a nd labelling system.  He suggested that any further concerns on 
this point be addressed directly to the Ministry of Environmental Protection of the People's Republic 
of China.  Finally, he noted that relevant documen ts and requirements could be found on the official 
website of the Ministry of Environmental Protection.6 
                                                      
6 http://english.mep.gov.cn/ .  G/TBT/M/53 
 Page 25 
 
 
  (xv) Korea – PVC flooring material and Wallpaper and paper linoleum, and toys 
(G/TBT/N/KOR/303 and Add.1 and  G/TBT/N/KOR/304 and Add.1) 
135. The representative of Japan  referred to the above-mentione d measures notified by Korea 
which restricted utilizing specific pl asticizers such as DEHP, DBP and BBP in PVC.  He said that his 
government had serious concerns about the lack  of scientific evidence on which the new draft 
requirements were based.  Japan was of the view that restrictions on cheap and useful PVC products 
could have a significant trade impact on many developing countries in the world.  He asked South Korea to make publically available the scientific ev idence that related to the content restrictions; 
particularly those for limiting the total amount of cer tain hazardous chemicals to less than or equal to 
0.1 per cent.   
136. The representative of the United States
 also expressed concern about the proposed content 
limits of 0.1 per cent for the three phthalates DEHP (Di-Ethyl Hexyl Phthalate), DBP (Di-butyl Phthalate) and BBP (Butyl benzyl Phthalate) in  certain uses, particularly for PVC flooring and 
wallpaper.  According to the US industry, these limits effectively prohibited the use of these 
substances in these applications.  He noted that th e substances were used as plasticizers in vinyl 
flooring and wallpaper to make them  flexible, durable and easy to main tain.  He said that currently the 
phthalates were restricted in children's toys a nd childcare articles in the United States and other 
countries where concern had been expressed about th e potential for relatively high exposures in these 
products to children.  The US Environmental Prot ection Agency (EPA) has expressed general concern 
about phthalates because of their toxicity a nd the evidence of general pervasive human and 
environmental exposure to these chemicals.  More over, a plan had been published that outlined a 
number of actions currently being pursued, or that  were under consideration by EPA, to better assess 
exposure and potential safety concerns with phthalates.  However, for the measure at issue, if the new 
Korean regulations were adopted they would be, it was the US understanding, among the first in the 
world to restrict the use of these substances in  flooring and wall coverings.  Therefore the United 
States also asked Korea to provide scientific and tech nical information that supported applying the 0.1 
per cent limit in this context. 
137. The representative of Korea
 said that almost all houses in Korea used – and had used for 
centuries – a unique under-floor heating system called "ondol".  Due to this system, most of the houses in Korea used PVC flooring materials and wa llpaper.  When heated, PVC flooring material 
and wallpaper could emit hazardous substances like DEHP, DBP and BBP.  Thus the purpose of the 
Korean regulation was to protect consumers' health  from these hazardous substances.  It had already 
been scientifically proven that DEHP, DBP and BB P were dangerous; they had been categorized as 
hazardous chemicals.  Based on this, the content limit in infants' and childrens' products had been set 
at less than or equal to 0.1 per cent in many countries, including the United States, the European 
Union, Japan, and other countries.  As houses were utilized by adults, children and infants – this 
needed to be taken into consideration; regulati ons had to be extended to any product containing these 
substances that could have contact with infants and children.  This was the rationale behind the 
Korean draft measure.  Currently, the Korean Agency for Technology and Standards (KATS) was 
collecting comments from stakeholders and taking them into account.   
(xvi) Indonesia – Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia 
National Standard for electroiysis tin coated  thin steel sheets.  (G/TBT/N/IDN/46) 
138. The representative of Korea
 referred to a draft measure from the Indonesian Ministry of 
Industry on the mandatory implementation of the In donesian National Standard for electrolysis on tin-
coated, tin steel sheets.  While Indonesia's desire to protect consumer safe ty was understandable, the 
Korean steel industry had expressed several concer ns regarding the proposed regulation.  Problems 
faced by Korean steel manufacturers included, for example, the large number of sampling tests, 
delayed factory inspection and shipment sampling.   The representative from Korea said that this G/TBT/M/53 
Page 26  
 
  imposed a heavy burden to manufacturers and creat ed unnecessary obstacles to international trade.  
He asked the Indonesian Ministry of Industry to ma ke efforts to find a constructive solution, including 
reducing the number of sample tests.  The Korean  standard for steel product required just three 
samples, and this system was sufficient to protect  consumer safety and to ensure product quality.  
Additionally, as the new technical guidance for th e implementation of the decree had not yet been 
released, Korean steel manufacturers were having diff iculty in preparing to apply for SNI certification 
for electrolysis tin-coated, tin steel sheets.  The re presentative of Korea therefore invited the relevant 
Indonesian authorities to provide his delegation w ith further information and detailed technical 
guidance, including the date of entry into force as soon as possible.  He said that a longer transition 
period would be helpful.  
139. The representative of Japan
 noted that his delegation was also seriously concerned about the 
possible further expansion of mandatory standards fo r steel imported from Japan; this was steel that 
was covered by strict quality management systems at steel mills in Japan, certi fied by ISO 9001.  He 
noted if the scope of mandatory standards was exte nded, more time and cost would be required to 
receive and maintain certifications.  This was likely to  have a serious impact on foreign trade, such as 
by increasing distribution costs and delaying deliveries at major industries in Indonesia.  Indeed, these 
negative impacts were likely to make industries in  Indonesia less competitive in global markets.   
140. The representative of the European Union  also expressed concern about the Indonesian 
measure which rendered Indonesian  national standards mandatory for different kinds of steel 
products.  It was the EU view that third part y certification for these products was more trade 
restrictive than necessary.  The Eu ropean Union therefore invited Indonesia to consider accepting 
Supplier’s Declaration of Conformity (SDoC) as pr oof for compliance.  The European Union also 
wanted to know why Indonesia considered it n ecessary to impose a mix of requirements coming from 
different standards and could not refer to  relevant international standards.   
141. The representative of Indonesia  noted that the draft measure had been notified and bilateral 
discussions with Korea were underway and concerns we re being taken into account.  He stressed that 
the objective of the draft measure was that of prot ecting consumers.  Indonesia would remain open to 
discussions – he said, moreover, that Indonesia could accept certifications from other countries. 
2. Previously raised concerns 
(i) European Union – Regulation on the Regist ration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52 and Adds .1-6; Add.3/Rev.1; G/TBT/N/EEC/295 and 
Add.1; G/TBT/N/EEC/297; G/TBT/N/EEC/333-6) 
142. The representative of Argentina  reiterated concerns with the co mplex nature of the Regulation 
on the Registration, Evaluation and Authorization of Chemicals (REACH), and stated that the 
measure was an unnecessary obstacle to trade.  He  highlighted the serious difficulties faced by 
Argentine companies as a result of the non-transpar ent regulations of REACH, and the excessive costs 
involved in abiding by them. Both issues made it di fficult for argentine compan ies to remain in the 
European market.  He said that concerns with l ack of transparency around REACH were accentuated 
by the failure of the European Union to provide  concrete and direct responses to the questions 
previously raised by Argentina.  He said that pr actical responses to these questions were essential to 
ensure predictability for Argentin e companies operating in the Europ ean Union.  He also underscored 
the provisions in Article 77 of REACH that recognised the need for capacity building and technical assistance to help developing countri es comply with the regulations.  
143. He also noted that the impact of increased costs was particular ly significant for non-European 
Small and Medium Enterprises (SMEs), which faced hi gher costs than those of European companies.  
He cited the example of the regulation that required non-European companies to open an office in the  G/TBT/M/53 
 Page 27 
 
 
  European Union to continue operating in within the Union; or to have a contract representative who 
represent it at a cost of U$S160,000 per chemical s ubstance.  Additionally, he noted that companies 
needed to also consider studies, the compilation of  data, and bureaucratic issues, to ensure full 
compliance with REACH.  The disproportionate cost structure was beneficial for larger companies, 
and against the interest of smaller and extra-community enterprises.  He urged the European Union to 
establish means for cost reduction for the registration of  SMEs to offset this situation, and to ensure 
compliance of the regulation with the National Treat ment principle.  He reiterated Argentine support 
for the objectives of protection of health, and of the environment that REACH sought to achieve.  
However, he also re-emphasised the concerns raised by Argentina on the difficulties faced by 
Argentine companies in implementing the regulations  contained in REACH, which continued to pose 
an unnecessary technical barrier to trade.  He en couraged the European Union to consider his 
comments, and provide better solutions so to ensu re that Argentine companies were not excluded 
from the European market.  
144. The representative of Canada  raised long-standing concerns over REACH.  He highlighted 
bilateral discussions between Canada and the Eu ropean Union on the subject, but refrained from 
discussing the details of the concerns raised therein.  He put on record Canada's interest in genetically 
modified oils, and a lack of clear understanding as to how they would be treated under REACH, and requested further information in this respect.  Additi onally, with reference to the subject of substances 
in articles, he once again asked th e European Union to ensure that the implementation of provisions 
was conducted in a manner that was least trade-restri ctive.  On the subject of Substance Information 
Exchange Forums (SIEF), he expressed Canada's interest in understanding how the European Union 
would ensure that membership to said groups w ould not be unduly or arbitrarily restricted.  
145. The representative of China
 noted that his delegation was looking forward to the bilateral 
meeting with the European Union the following day, but also said he would like to seize the 
opportunity to express the different concerns that Ch ina had with regards to the analytic spectrum of 
REACH, which were also raised in the previous TBT meeting by China.  He also expressed concern 
about the non-transparent and unreasonable cost-s haring mechanism of so me substances’ REACH 
registration, which imposed registration costs of Euro 278,522.56 for1-bromopropane, and Euro 
159,051 for oxalic acid, which directly impacted Chinese enterprises.  
146. The representative of India  sought clarifications and offered comments on REACH.  He first 
requested that the logic of registration of monomer s be clarified, since the lifecycle of a monomer 
ended once it reacted into a polymer.  He noted that  monomers were stable in polymers and did not 
have separate risks of their own.  He also noted that the information provided on monomers did not 
cover the risks associated with polymers.  He co mmented on the creation of the SIEFs and consortia, 
which were outside the purview of regulatory contro l, and had the potential to be dominated by EU 
industry, placing a high burden on SMEs.  He unde rscored some of the concerns associated with 
SIEFs, such as a high joining fees, non-uniform rules of consortium, penalties for late joining, annual 
maintenance fees, cost of acceptance letter,  and high fees for lead registrants.  
147. The representative sought clarification as to the rationale for registration of the entire tonnage 
of substances in an article, even if less than 100 per cent of the substance was to be released.  He 
explained that this increased the tonnage ban for registration, and imposed a higher burden on the 
registrant.  Further, he underscored that the defi nition of SMEs, for the purpose of lower registration 
costs, was flawed.  The definition covered both annual turnover and number of employees, which 
classified Indian SMEs in the large enterprise category, and increased their registration fee.  
Additionally, he noted that no special and differentia l treatment was provided with regard to the cost 
of sharing data.  He also expressed concerns on the prohibition of new animal testing, which made the 
cost prohibitive, and increased the financial burde n for SME registrants.  Finally, he expressed 
concerns over the high costs of sharing data in  SIEFs and presented a rationale for encouraging 
computer simulation of chemical testing, and suggest ed that the European Union explore this option.  G/TBT/M/53 
Page 28  
 
  148. The representative of Japan
 voiced two main concerns.  First, he raised Japan's concerns with 
the implementation of REACH, including the interpretation of 0.1 per cent threshold.  He said that the calculation for the threshold value for substances of very high concern (SVHC) was made based on 
the whole product, including the assembled product.  However, he noted that some EU member states 
had proposed to amend the interpretation of the arti cle to calculate by parts, such as nuts and bolts, 
and that discussion was reportedly on-going on the subject.   
149. He commented that the Japanese government r ecognised that the issue had already been 
legally judged and that the present interpretation wa s to be implemented, how ever, his delegation was 
still concerned that the opaque action to amend the interpretation without amending the law, a mere 
three months prior to the implementation, woul d impact importers as a non-tariff barrier.   
Additionally, he expressed concerns about inconsis tent interpretation within the European Union, 
which could lead to individual EU members exerci sing their discretion in stopping importation.  He 
also indicated that the Japanese government had wr itten to the European Chemicals Agency (ECHA) 
on 21 February 2011, highlighting these concerns and urging the European  Union to clarify and 
implement the current policy with coherence, and ensure that individual EU member states were 
consistent in implementing the policy. 
150. The representative next raised concerns related to the enforcement of REACH.  He explained 
that the Japanese government had learnt that large- scale inspection had been put in place to ensure 
compliance with REACH in the European Union.  As  part of this inspection, he reported that EU 
inspectors had in some cases been demanding more information than legally requested.  He urged the 
European Commission and the ECHA to ensure appr opriate enforcement of REACH, and to ensure 
that inspectors did not demand more information than legally requested.  
151. The representative of the United States
 said that his delegation shared the EU's concerns over 
the protection of human health and the environment.  However, he drew attention to the fact that the 
European Union had never addressed the trade- related concerns raised by REACH and its 
implementation.  He cited concerns with supply ch ain impacts, the only representative issue, and the 
monomers and polymers issue, which had been previous ly raised at this meeting and past meetings.  
He was also concerned with different interpretations  of the 0.1 per cent threshold for the notification 
and communication of substances on the candidate lis t to downstream users.  There was a lack of 
clarity on the subject, and he noted the difference of opinion between the Commission and certain EU 
member states as to whether the threshold applie d to an entire product, or to its individual 
components.  He requested updates and clarification from the European Union, and said that his 
delegation would continue to closely m onitor the implementation of REACH.  
152. The representative of Australia  strongly reiterated concerns with REACH, and voiced 
Australia's support for the concerns raised by othe r Members on the subject.  He referred Members to 
the minutes of previous meetings for furthe r information on Australia's concerns.   
153. The representative of Cuba  highlighted concerns already voiced in previous meetings with 
reference to the technical progress undertaken by th e European Union, in particular, regarding the 
classification, labelling, and packaging of s ubstances and compounds.  He also expressed 
disagreement with the European Union's reclassi fication of Nickel compounds, which he noted, was 
based on an inadequate method and insufficient scientific  data.  This put the reclassification at the risk 
of being erroneous, and also undermined the need for a measure adopted in compliance with the TBT 
Agreement.  He also noted that while the European Union had affirm ed that the repercussions of the 
restrictions would be limited only to Nickel com pounds, Cuba had observed that they had resulted in 
strict and expensive prescriptions and had increased costs of transportation and storage.  He also noted that stigmatizing of Nickel could reduce its global demand and lead to losses for nickel-using industries.  Additionally, he commented that classifi cations and restrictions of  such nature could have 
repercussions for developing countries such as Cuba, dependent on income derived from Nickel.  He  G/TBT/M/53 
 Page 29 
 
 
  hoped that the European Union would act transparen tly and focus on available scientific information 
when examining the impact of Nickel on human health, and when making the relevant classifications.  
154. The representatives of the Philippines , Thailand  and the Bolivarian Republic of Venezuela  
reiterated their previously raised concerns with the REACH regulation, as well as the concerns raised 
by other Members.  
155. The representative of the European Union  announced that REACH had passed another 
significant milestone with reference to implementati on, since the deadline for registrations for certain 
classified phase-in substances, and for substan ces manufactured or imported in quantities of a 
thousand tonnes or more annually, had recently p assed (30 November 2010).  She informed Members 
that registration had gone smoothly, and that no major problems had emerged in the process.  She 
stated that 24,675 registration dossiers had been re ceived by 30 November 2010, covering a total of 
4,300 substances, which had been in line with th e volume expected.  She also said that to date 
approximately 86 per cent of registrations had co me from large companies and 14 per cent from small 
and medium enterprises, and 19 per cent of registra tions had been made by "Only  representatives".  
She explained that the numbers highlighted that, co ntrary to comments made by Members at meetings 
of the TBT Committee, the registration process was not overly complex or burdensome, that the 
SIEFs were functioning and that SMEs and non-European companies had been able to submit their 
registrations.  Additionally, she noted that wo rk by ECHA in the evaluation phase had proceeded 
well.  She reported that by the beginning of Marc h, registration numbers had been granted for 20,175 
dossiers submitted by the deadline, resulting in a total of 3,483 phase-in substances registered. 
156. The representative noted that the European Co mmission and the ECHA continued to make all 
possible efforts to help industry to make the SIEFs  function.  She recalled that her delegation had 
several times elaborated on the efforts being made.  Sh e stated that there were no issues with regard to 
the participation of non-European registrants in the SIEFs, as implied by Canada, since they could 
participate through the appointed "Only Representative" . With regard to the question raised by India 
on consortia activities in SIEFs, she noted that the European Union had previously replied to the 
question.  She reminded the Committee that REACH di d not regulate the formation of consortia, and 
that such activities were entirely voluntary and in the hands of industry.  However, relevant work that 
had been developed in a consortium was part of th e information that were to be exchanged in the 
SIEF and was therefore accessible to all registrants for the same substance, even if they did not 
participate in the consortium.  
157. In response to the question of cost sharing in SIEFs, she again noted that REACH had left the 
costs sharing to industry.  She explained that in  a situation where no agreement was reached between 
participants, REACH foresaw that costs would be shared equally., Article 30 of REACH also obliged 
participants to share cost in a fair, transpar ent and non-discriminatory manner.  The representative 
said that she did not understand China's referenc e to certain amounts with regard to specific 
substances, but that she was willing to follow up in the bilateral meeting the next day.  
158. Responding to Canada's questi on on genetically modified o ils and the Annex V guidance 
document on exemptions, she said that there were  no plans to up-date this guidance document 
immediately, but that Canada was aware of the European Commission's position in this regard and 
that there had been no changes on that front. 
159. With respect to India’s question on monomers a nd polymers, she referred to the minutes of 
the previous TBT Committee meeting for her dele gation’s responses.  She informed the Committee 
that the guidance on monomers and polymers was bei ng updated with reference to the calculation of 
the reacted and non-reacted polymer, as well as the chemical safety assessment.   G/TBT/M/53 
Page 30  
 
  160. On the issue of the 0.1 per cent threshold for ar ticles, raised by Japan and the United States, 
she said that the official position of the Eur opean Commission could be found in the guidance 
document.  The substance concentration threshold of 0,1% applied to the article as produced or 
imported and not to homogeneous  materials or parts of an article.  She agreed that certain EU member 
states had expressed a different view on the subject , and referred to her expl anations in past TBT 
Committee meetings to note that in case of such an event, it was up to the European Court of Justice 
to make a final decision, which would be the final interpretation on the subject.  
161. In response to India's question on the rationale of the one-tonnage criteria for registration of 
substances in an article, she clarified that this criteria was consistent with the requirements of the 
registration of substances, and that it focused on th e presence of certain substance in the article, and 
not on the quantity released from the article, in orde r to ensure coherence with registration of the 
substances.  She also responded to India's question on animal testing and the possibility of conducting 
computer testing.  She explained that the EU ai med to balance animal welfare concerns with the 
obligation to pursue research for the benefit of  human being, animals and the environment and 
underscored the pragmatism of the approach of th e European Union that aimed to reduce animal 
testing by introducing alternative measures that c ould eventually replace animal testing.  With 
reference to computer testing, she explained that the European Union had a programme supporting projects on alternative testing strategies, for example, computational modelling and estimation 
techniques, bioinformatics and computational  biol ogy, cell based technologies and integrated testing 
strategies.   
162. On question of diverging enforcement in diffe rent member states, she explained that the 
enforcement of REACH laid indeed within the competence of EU Memb er States.  She asked Japan to 
provide more precise information on cases when inform ation had been requested that could not have 
been legally requested under REACH.  She assured that if examples were provided the European 
Commission could further assess the issues and discuss it with member states if necessary.  
163. On the intervention from Cuba, she noted that it was focused mainly on the classification of 
nickel compounds and borates through the Regulatio n on Classification, Labelling and Packaging of 
Substances and Mixtures (ATPs and CLP)
7 and was not directly relevant to REACH.  However, in 
relation to nickel compounds and borates she inform ed the Committee that the revision of Annex 
XVII of REACH8 was still being discussed and that any chan ges to the proposed text would be re-
notified.  
164. Finally, on the comments from Argentina on technical assistance, she noted that her 
delegation had previously replied to  this query on several occasions, but highlighted that a series of 
training sessions and 16 webinars we re provided in 2010 by the ECHA,  which were accessible via the 
internet and attracted over 10,000 participants.  She invited experts to participate in similar seminars 
offered in the future.  She also reminded Members th at the ECHA help desk was available to provide 
responses to concrete requests from industry.  Finally, she said that her colleagues had met 
Argentina's representatives some days ago in Bru ssels, and that detailed explanations had been 
provided to the specific questions from Argentina at this occasion. 
                                                      
7 G/TBT/N/EEC/151 and Adds.1-2; G/TBT/N/ EEC/212 and Adds.1-3; G/TBT/N/EEC/163 and 
Adds.1-3, Add.1/Corr.1. 
8  G/TBT/N/EEC/297.  G/TBT/M/53 
 Page 31 
 
 
   
(ii) European Union – Directive 2002/95/EC on the Restriction of the Use of certain Hazardous 
Substances in Electrical and Electronic Equipm ent (RoHS) and Directive 2002/96/EC on 
Waste Electrical and Electronic Equipm ent (WEEE) (G/TBT/N/EEC/247, Add.1 and 
G/TBT/Notif.00/310, Corr.1) 
165. The representative of Japan  highlighted the difference between G/TBT/N/EEC/247, the 
proposal for the directive of the Eu ropean Parliament and of the Council on the restriction of the use 
of certain hazardous substances in electrical and el ectronic equipment – RoHS – and the text that had 
been recently adopted in November 2010.  He not ed that these differences would have a dramatic 
impact on countries outside the European Union, citing the example of additional restricted 
substances. He therefore recommended that the European Union re-notify the latest text. 
166. He also made additional comments on the RoHS recast. First, he expressed concern with 
procedures to review exemptions under the RoHS rec ast, within Section 2 of Article 5 and Annex III.  
He said that the RoHS recast defined the exemptions  in Annex III to cover all categories.  However, 
he noted that the applicable terms differ between categories and that the maximum terms of validity 
were also different in different categories.  This, he said, meant that reviews for different categories 
would take place at different times, and he expr essed concern about adverse impact of such a 
measure.  He further explained that the first revi ew of Annex III for categories 1 to 7 and 10 on the 
list, was scheduled to occur in five years.  At the same time, for categories 8, 9 and 11, application 
would begin in three to six years, while the revi ew of Annex II was scheduled to occur within a 
maximum of seven years from the start of the applica tion of the directive.  He noted, therefore, that 
the timing of review for categories 1 to 7 and 10 coul d differ from that for categories 8, 9 and 11; and, 
that the result for the first review for categories 1 to 7 and 10 could adversely impact the review for 
categories 8, 9 and 11.  
167. Second, he expressed concern regarding additiona l restricted substances included in the RoHS 
recast.  He requested the European Union take acc ount of Article 2.1 of the TBT Agreement while 
considering the assessment of additional restricted substances in the RoHS recast, to ensure fairness 
for economies outside the European Union.  He also noted that a review to add restricted substances 
to the six substances already on the list would be held three years after the directive came into force.  
He emphasized that if the review were to lead to  additional substances bei ng included the restricted 
list, exemptions should be provided for substances for which reliable alternative technologies could 
not easily be found, or for which moving to alte rnatives would impose negative social and economic 
impacts.   
168. Moreover, he underscored the necessity of pu blic consultation within and outside the 
European Union in order to conduct risk and impact assessment regarding waste, recycling, and reuse, 
for implementation of revised regulations.  Lastly, he highlighted the need for allowing sufficient time 
when putting new regulations into place.  
169. The representative of the European Union  provided an update on the st atus of the recast of the 
RoHS directive.  She confirmed, as stated by the representative of Japan, that the first reading of the 
European Commission proposal had been adopted on 24 November 2010.  She explained that this document had been notified as G/TBT/N/EEC/247/Add. 1, on 18 March 2011.  She explained that the 
European Parliament, Council and Commission had c ooperated to achieve the first reading agreement 
on the draft directive.  She also said that, followi ng the Parliament's vote on it in the plenary in 
November 2010, the draft Directive was currently with the Council.  Formal adoption by the Council 
was expected within a short period of time, and the Commission was also in agreement.  As a result, 
the new directive, she said, was expected to enter in force as early as May 2011.  G/TBT/M/53 
Page 32  
 
  170. On the subject of the European Parliament's first reading position, she noted that the most 
significant change had been with regard to the introduction of an open scope to the RoHS, i.e. 
extending coverage to all electrical and electronic e quipment with specific exclusions.  In return, if 
adopted in its current form, the directive would gr ant a transitional period of eight years after entry 
into force for products not covered by the old Dir ective.  Additionally, she noted that the list of 
exclusions from the new scope had been extended significantly, to include, inter alia , large-scale 
stationary industrial tools or fixe d installations, means of transportation, certain machinery, active 
implantable medical devices,  and photovoltaic panels.  
171. She also highlighted that the maximum valid ity period of exemptions from the substance 
restrictions had been extended from four to five years, with seven years for medical devices and 
monitoring and control instruments.  She explaine d that exemptions would be decided on a case-by-
case basis, and could be renewed.  Finally, she al so said that Annex III of the original Commission 
proposal, containing the list of priority substances that  could be candidates for future restrictions, had 
been deleted from the Parliament's proposal.  In return, a review mech anism for restricted substances 
had been developed in more detail.  She said that su ch a review would have to  be coherent with other 
chemicals legislations, in particular, REACH.  Sh e informed the Committee that the review would be 
carried out in consultation with interested parti es, including economic operators, and would be based 
on, inter alia , scientific evidence, assessme nt of the socio-economic impacts, information on the 
availability and reliability of possible substitutes, a nd justification for the appropriateness of an EU-
wide restriction. 
(iii) India – Pneumatic tyres and tubes for autom otive vehicles (G/TBT/N/IND/20 and Add.1; 
G/TBT/N/IND/40 and Rev.1) 
172. The representative of the European Union
 thanked India for the postponement of the entry 
into force of the order for an additional period of six months.  She noted that in the previous TBT 
Committee meeting the European Unio n and Japan had expressed serious concerns with regard to the 
restrictions in the Agreement for the grant of BIS licence in that foreign ho lders of the licence were 
only allowed to use the BIS mark on tyres exported to India, and not on tyres exported to other 
countries.  She also enquired if the same restriction applied to Indian producers.  If not, she stated that 
the measure was discriminatory.  
173. She explained that the current global practice was that tyres were marked with a number of 
different marks for different countries.  Therefore, she noted, the result of the Indian requirements was 
that producers had to produce tyres with the BIS mark alone for the Indian market.  This added 
significantly to the costs for foreign manufacturers,  which had to produce special tyre moulds for the 
Indian market, in addition to reorganising stocks and logistics.  She highlighted that on the other hand, 
Indian producers seemed to be allowed to use the same tyre mould for Indian markets, and for third 
country markets.  
174. She expressed concern over the issue of royalt y fees which were calculated based on the total 
number of tyres produced and marked with the BIS mark, and not based on the total number of BIS 
marked tyres which were de facto  imported into India.  The representative noted that if foreign 
manufacturers followed standard practice and marked  all tyres with the BIS mark, it would increase 
the royalty fees to a level that would make exporti ng tyres to India unattractive.  She also expressed 
disagreement with the Indian comment in the pr evious TBT Committee meeting that the measure 
would not restrict trade or exports to other markets.  Indeed, she pointed out that the requirements in 
the regulations were discriminatory and went against the principles of international trade.  She added 
that the requirements did not contribute to technical safety requirements and only had the impact of obliging manufacturers to produce tyres only for the Indian market, without any justification.  She urged India to consider amending these requirement s.  She also expressed concerns over the low 
number (only two) of laboratories accepted by Indi an authorities for the conformity assessment.  She  G/TBT/M/53 
 Page 33 
 
 
  noted that India had not yet addressed this issue in  its previous responses.  The representative asked 
for clarifications on what India was doing to overcom e the bottleneck of accepte d laboratories, and if 
under the circumstances, India would accept tyr es tested in international ILAC accredited 
laboratories.  
175. She was also concerned that once the order came  into force, the local technical Committee 
would have the power to select a list of tyres that would immediately fall within the requirements of 
the order as of the decision.  She noted that the order did not provide a transition period with respect to the decision.  Manufacturers of tyres would need to adapt their production very quickly, which did not appear to comply with the requirements of Artic le 2.12 of the TBT Agreement.  She requested that 
India provided a transition period of at least 6 months for manufacturers to adapt.  
176. Finally, the representative requested that India provided the response that they promised to 
the question of whether in-house testing facilities we re a requirement for the BIS licence, posed by 
her delegation the last TBT Committee meeting.  She urged India to clarify all issues before the order 
entered into force.  
177. The representative of Japan
 raised five points.  First, he noted that the Government of India 
had postponed the date of entry into force of the re gulatory act by an additional 180 days to 540 days 
from the initial entry into force date of 19 November  2009.  However, he noted that the number of 
tyres to be certified was increased resulting in the need for additional factories to be accredited, and 
the overall number of tyres tested.  
178. He said that while interested companies were  preparing to comply with the act and the 
requirement to test at laboratories designated by BIS, the BIS procedure was lengthy and included 
handling of the certification, and therefore, he re quested a further postponement of 180 days, in line 
with what Japan had requested in the previous  TBT Committee meeting.  He also spoke on the 
activities subject to regulations.   
179. Second, he highlighted that Article 3.1 of th e official gazette dated November 2009 prohibited 
tyres without ISI certification marks from being manufactured, imported, stor ed for sale, sold or 
distributed.  However, he noted that in terms of ac tivities subject to regulations, there were significant 
delays between manufacturing and selling or distributi ng the tyres.  He also underscored that several 
international regulations stipulated enforcement at th e time of manufacture.  He requested a review of 
that point and requested that if sale and distribution were subject to regulation, that a three-year lead-
time from entry into force on a production basis be provided.  
180. Third, he explained that the paragraph 6.3 that stipulated that tyres with an ISI mark could 
only be sold in India.  However, he noted that India had clarified that the stipulation in the BIS 
Agreement did not bar exports to other markets. In such a circumstance, he requested that the 
provision of paragraph 6.3 be eliminated. 
181. Fourth, he noted that paragraph 2 of the BIS Agreement on the use of BIS certification mark 
impose several charges such as the minimum marki ng fee, renewal application fees, annual licence 
fees, marking fees calculated on actual production ma rked, and any other fees as prescribed but in 
terms of number of kinds of fees.  He commented  that the fee was significant by international 
standards, in particular the fee based on tyre unit was unprecedented by any international measure, 
and he requested that it be eliminated.  Furthermore, he requested a review of other fees, and that they 
be made equivalent to ot her countries' regulations.  
182. Finally, he cited Provision 5, a quality control order of the Official Gazette issued on 9 
November 2010.  This provision enabled Indian authorities to demand information on manufacture, 
importation, storage for sale, sale or distributio n, notwithstanding that such information included G/TBT/M/53 
Page 34  
 
  confidential business information and know-how, relati ng to quality management, logistics, and other 
related systems.  Additionally, he noted that th is provision could be unjustly used to demand 
excessive or unnecessary information.  He therefor e requested elimination of this provision.  
183. The representative of Korea
 reiterated concerns over the aforementioned measure.  He 
commended the extension of entry into force by the Indian Government.  However, he noted 
difficulties faced by certain Korean tyre manufacturer s with respect to delays in factory inspection 
and sample testing.  It seemed impossible to obta in the BIS certification before 18 May 2011, and he 
once again urged India to accelerate the inspection a nd testing process.  If not, he requested that a 
longer transition period be provided.  The represe ntative echoed the concerns of other Members 
regarding the prohibition on selling tyres with the ISI mark outside India, noting that it deterred 
foreign tyre manufacturers from entering Indian market s.  Finally, he spoke on the subject of licence 
fees, and fees for renewal and marking, noting that they were significantly higher than those of other 
similar certifications, such as the E-mark.  He requ ested that the Indian authorities modify the fee 
structures forthwith.  
184. The representative of India  recalled that the original notification on automotive tyres and 
tubes was made in July 2006, and that at the ti me, industry was well aware of the intention of the 
Government to institutionalise a certification system .  He also said that the most recent notification 
dated November 2010 stipulated entry into force of the regulation in May 2011.  He noted that this 
time period was over five years from the initial notifi cation until entry into force, and therefore well 
longer then the time periods mandated by the TBT Agreement and the TBT Co mmittee Decisions.  He 
underscored that the provision in Article 3.1 merely endorsed the need for certification of all tyres that 
were manufactured, imported, stored for sale, sold , or distributed, and that such a clause was an 
accepted part of any regulation governing a certification system. He also noted that Article 6.3 of the 
BIS Agreement only stipulated that the ISI marking c ould only be used for exports of tyres to India, 
and was not trade-restrictive.   
185. He also noted that the recommendation to allow e xports of ISI-marked tyres to other countries 
was being considered by the BIS.  Further, he co mmented that the marking fee charged was equitable 
in terms of unit cost of tyres for both domestic a nd foreign manufacturers.  He also emphasized that 
India was not a signatory to the 1958 UNECE Agreement, and India was therefore not bound to follow all regulations of the UNECE on the automotive sector.  Furthermore, he highlighted that the 1958 UNECE was not a relevant international standa rd setting body since it did not comply with the 
principles of the 2000 TBT Committee decision.  Howe ver, he noted that several parameters of the 
UNECE standards had nevertheless been incorporated into the proposed regulations.  Additionally, he 
explained that the regulations complied with several  parameters of the ISO standard, including the 
tread wear indicator test, the tyre strength test, endurance test, BIT unseating resistance test, among others.  Finally, he said that the difference in climatic conditions, geographical terrain and road 
conditions necessitated the use of domestic standards in  India, creating a need for additional tests such 
as plunger and high-speed tests. 
(iv) European Union – Regulation on Classificati on, Labelling and Packaging of Substances and 
Mixtures (ATPs and CLP) (G/TBT/N/EEC /151 and Adds.1-2; G/TBT/N/EEC/212 and 
Adds.1-3; G/TBT/N/EEC/163 and Adds.1-3, Add.1/Corr.1) 
186. The representative of Canada
 reiterated strong concerns with the European Union's 
classification of substances containing nickel.  He  understood that the European Court of Justice 
would soon issue an opinion on the classification of nickel substances, and expressed continued 
concern on the need for transparency and sound scientific basis for the classification, given the 
potential to negatively impact nickel producers.  He  urged the European Union to ensure that the 
classification did not pose an unnecessary obstacle to trade.   G/TBT/M/53 
 Page 35 
 
 
  187. The representative of Australia  expressed continued concerns with the European Union's 
decision to reclassify nickel compounds, and noted that  concerns of other Members had also remained 
unaddressed.  He strongly reiterated previously expre ssed interventions by Australia, and referred to 
the formal minutes of the TBT Comm ittee for additional information.  
188. The representative of Turkey  reiterated her delegation’s concerns over 30th and 31st ATP of 
the regulation of classification, labelling and packag ing of substances and mixtures.  However, she 
refrained from repeating Turkey's previous comments,  and instead referred to the minutes of previous 
meetings.  She voiced expectations that the Euro pean Union would have noted those concerns and 
amend the regulation accordingly.  
189. The representative of Philippines  also expressed support for the concerns raised by the other 
delegations on the subject and reitera ted concerns raised by the Philippines in past meetings of the 
Committee.  The representative of Thailand also voi ced support for the concerns raised by other 
Members on nickel classification, and requested the Eu ropean Union to ensure that the reclassification 
was based on solid scientific findings 
190. The representative of the Dominican Republic  also reiterated concerns of the Dominican 
Republic on the issues of reclassification of nickel containing substances.  She voiced two objections 
on the manner in which the European Union had implemented the methodology for the classification 
of nickel substances, and noted that she wished to  repeat what Turkey had already highlighted in 
previous meetings in 2008, 2009, and 2010.  She ur ged the European Union to reconsider its position 
on the subject.  
191. The representatives of Cuba  and the Bolivarian Republic of Venezuela  reiterated concerns 
that had already been voiced in previous meeti ngs, and had been expressed by previous speakers. 
192. The representative of the European Union  informed the Committee that she had no new 
information beyond what had already been provided  in previous meetings.  She referred to the 
numerous lengthy responses provided by the Europ ean Union in previous meetings, which were 
incorporated into the minutes of those meetings.  Sh e did, however, address the issue raised by Turkey 
at the previous Committee meeting regarding a study  carried out in China in a Boron mine.  She 
thanked Turkey for submitting the survey to the Euro pean Union and confirmed its receipt.  She also 
informed Members that as per the procedures of  the CLP regulation, any changes made to the 
classification of substances could only be made if the proposal was submitted by a Member State to the ECHA.  Therefore, she explained that any intere sted delegation or industry that sought changes to 
specific classifications would have to submit a dossier to an EU Member State to trigger submission 
of a proposal to ECHA.  She also clarified that t hus far, they had not received any such request from a 
third country or industry. 
(v) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203 and Add.1) 
193. The representative of New Zealand
 reiterated on-going concerns with the Canadian 
compositional requirements for cheese.  As stated in  previous meetings, her delegation believed that 
the requirements were inconsistent with the releva nt international standard  (Codex Alimentarius).  
She requested an update from Canada on the devel opments in the domestic court proceedings and 
domestic industry lobbies in this respect.  
194. The representative of Australia  supported New Zealand's conc erns on the aforementioned 
Canadian regulations.  He reiterate d Australian broad concerns with the measure, and noted that this 
delegation shared the concerned previously raised  by New Zealand on access to milk proteins.  He 
also sought updates on the appeal process in the Federal Court in Canada.  G/TBT/M/53 
Page 36  
 
  195. The representative of Canada
 noted that previously received comments had been taken into 
account.  He explained that thus far, imported ch eeses had been found to be in compliance with 
Canadian standards.  On the subject of the judici al process in Canada, he noted that in previous 
meetings Canada had informed the Committee that th e original review was held in April and March 
2009, and that the Federal Court had dismissed the a pplication for judicial review in October 2009.  
The decision however was appealed, and most recently , the appeal was heard on 9 February 2011, and 
the Federal Court of Appeal once again ruled that the appeal be dismissed on 28 February 2011.  
Thus, the judicial review process was concluded.  He  also responded to the question previously raised 
by New Zealand, and explained that no regulatory processes had been initiated to establish standards 
for any other dairy products. 
(vi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
196. The representative of the European Union  reiterated previously raised concerns on the Indian 
order establishing a registration procedure for imported cosmetic prod ucts, notified under 
G/TBT/N/IND/33, and expected to enter into force on 1 April 2011.  Her delegation remained of the 
view that a notification system, instead of a registration or authorisation system, was a less trade 
restrictive measure to ensure consumer safety.  More importantly, she questioned the grounds of the 
validity period of the Cosmetics Registration Ce rtificates and import licences; those for foreign 
manufacturers lasted three years, whereas those for I ndian manufacturers lasted five years.  She also 
asked the Indian Government to confirm that in  this regard, the validity period of foreign 
manufacturers would be increased by two years, so to be aligned with the rules and conditions that 
applied to Indian cosmetic manufacturers.  
197. In the event that India chose to  continue with its current pro cedure, she requested that India 
ensure that the registration certificates would be issued within a maximum period of two months, and that the tests conducted in the country of origin attesting compliance with international cosmetic 
standards would be accepted.   
198. The representative of India
 confirmed that this measure had first been published as a 
notification dated 19 May 2010, and that a subse quent amendment dated 19 June 2010 would bring 
the rules into effect from 1 April 2011.  Therefor e, he noted that a reasonable interval between 
publication and entry into force had been provided.  He also said that that notification was based 
purely on public health concerns of consumers. He  emphasized that the provisions of the amendment 
did not discriminate between foreign and domestic manuf acturers.  A system of registration of imports 
of drugs had been in place since 2003, and the draft rules pertaining to the registration of cosmetics 
had been published in document GSR/63/E dated 2 Fe bruary 2007.  He said that copies of the rules 
had been circulated to the TBT Committee for comme nts, and that concerns of both the European 
Union and the United States had been taken into cons ideration prior to finalising the amendment.  In 
this regard, he confirmed that the clause that ha d then been objected to, regarding the inspection or 
visit of manufacturer premises by the licensing authorit y of India, or by any authority that had been 
delegated the power to do so, had been deleted. 
(vii) Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96 and Adds.1-4 and Add.4/Rev.1)   
199. The representative of the European Union  acknowledged the Colombian notification of 7 
January 2011 of the draft amendments to the Colo mbian legislations of 2007 and 2009 on the use of 
alcohol fuels in petrol-fuelled motor vehicles.  She noted that the draft required all vehicles to use, as 
of 1 January 2012, ethanol blends with in a range of E8 to E12.  Furthermore, the draft required that as 
of 1 January 2015, conventional vehicles would use E 10 to E20 fuels, while flex-fuel vehicles would 
use E25 to E85 fuels.   G/TBT/M/53 
 Page 37 
 
 
  200. She said that the European Union welcomed the proposed revision and the fact that the 
mandatory shares of bioethanol, as well as the timelin es, had been made more flexible.  She expressed 
appreciation for Colombia’s quick written repl y of 18 March 2011 to her delegation’s written 
comments and for Colombia's explanations abou t the assessments that had been made on the 
feasibility of the use of different ranges of ethanol fuels.   
201. However, the representative expressed continue d concern over the fact that not all the 
required ethanol blends would be available in Colo mbia as of 1 January 2012, or perhaps would not 
be available in the whole territory.  She refe rred to the European Union's written comments, 
reiterating that the standard range used worldwide, including in the European Union, was E10.  She said that as a result, with the exception of flexifue l vehicles, engines capable of coping with blends 
greater than E10 had not been developed to date.  Finally, she requested information as to how the 
availability of all ranges of ethanol blends in the draft would be ensured.  
202. The representative of Japan
 expressed his support for the EU position, and said that given that 
the development of automotive technologies required time, Colombia's proposed regulations on the 
use of biofuels did not provide adequate transition time.  He underscored that a majority of vehicles 
on Colombian roads could only adapt to E10 grade of fuel in regular-grade and premium gasoline, and 
those vehicles would continue to run on Colombian roads even post 1 January.  Additionally, he noted 
that vehicles, which were not technically compatible  with the regulatory provisions, would continue to 
be supplied to the Colombian market post 1 January  2012.  He said that it was therefore necessary to 
ensure that vehicles that adapted only up to E10 fuel would not be excluded from the Colombian market.  He expressed concern that the new regulations would place severe limitations on the 
automobile industry, as well as jeopardise th e interests of Colombian consumers.  
203. He requested that the Colombian government ease the E8-E12 regulation to a maximum of 
E10 and guarantee the continued supply of E10 gaso line to the Colombian nationwide market after 1 
January 2015.  He also requested that the Co lombian government implement measures that were 
necessary to ensure that users of vehicles did not mi stakenly refuel their vehicles with gasoline with 
which their vehicles could not adapt.  Finally, he requested that the Colombian government take into 
account concerns raised and reiterated by the Japanese auto-industry while formulating the new 
regulations.  
204. The representative of Colombia
 acknowledged the concerns raised  by Japan and the European 
Union, and confirmed that they had been passed on  to the Ministry of Energy, which was the body 
responsible for this regulation.  He also confir med that responses to queries had been passed on to 
Japan and the European Union.  Given that th e responses had only recently been provided, his 
delegation was willing to further enga ge in bilateral meetings with in terested Members.  Finally, he 
reiterated that the measure was under revi sion by various entities in the country. 
(viii) United States – Consumer Product Safety Impr ovement Act (G/TBT/N/USA/421 and Add.1) 
205. The representative of China  reiterated his delegation’s serious concerns over the US 
Consumer Product Safety Improvement  Act (CPSIA).  He expressed a ppreciation for the clarification 
provided by the United States on some issues of  the CPSIA and information provided on the 
Consumer Product Safety Commission (CPSC) website.9  However, he noted that China's concerns 
had not been adequately addressed.  First, he understood that the CPSC would solicit comments from 
the public as to the scheduled August 2011 reduction of the maximum lead content in children’s 
products from 300ppm to 100ppm.  China agreed with purpose of the legislation, namely the 
protection of children's health, which was a comm on practice among Members, including in China.  
However, he reminded the United States that techni cal regulations should not be made more trade 
                                                      
9 http://www.cpsc.gov/ . G/TBT/M/53 
Page 38  
 
  restrictive than necessary to ensure  compliance with the TBT Agreemen t.  He shared the opinion of 
Chinese industry that the new limit was unscientific and inappropriate in the TBT context, since only 
soluble lead could actually harm children's health.  He therefore recommended that the United States 
make a distinction between soluble lead a nd insoluble lead while setting new limits.  
206. The representative underscored the need to base more stringent limits on scientific evidence 
to avoid unnecessary barriers to tr ade.  In addition, he requested a longer transitional period in 
accordance with the special and differential treatment  principle of the TBT Agreement, since toys 
were mainly produced in developing countries.  He also expressed an outsta nding concern with regard 
to the discriminatory treatment against China Inspec tion and Quarantine (CIQ) laboratories.  He first 
noted that all five stipulations for governmental labor atories in CPSIA were irrelevant to the technical 
contents of laboratories, and were therefore ina ppropriate.  Second, he co mmented that Chinese CIQ 
laboratories were run by indepe ndent legal persons who conducte d testing and inspection work 
impartially within the legal framework of China.  Third, he noted that the majority of China's 
laboratories were also accredited according to  the ISO/IEC 17025 standards, which fulfilled the 
criteria of the third party common assessment body within the meaning of CPSIA.   
207. Furthermore, he responded to the US argumen t that CIQ laboratories enjoyed preferential 
treatment in comparison to other laboratories, which he characterized as incorrect.  In reality, he said 
that CIQ laboratories only issue test reports within their competencies, and had no right to issue safety 
and quality export permits.  He expressed hope that the United States would remedy the misunderstanding and take concrete steps to allow CIQ laboratorie s to function in good faith.  He also 
said that China was looking forward to further bila teral discussions with the United States on the 
subject.  
208. The representative of the United States
 suggested that China su bmit comments on the issues 
raised with respect to the outstanding concerns on the recognition of Government laboratories.  He 
referred to the response of the United States in the pr evious meeting stating that the CPSC had already 
recognised at least 14 government joint venture labo ratories in China.  He also mentioned that US 
regulators had been in regular discussions with th e General Administration of Quality Supervision, 
Inspection and Quarantine (AQSIQ) on the issue of CIQ laboratories and had already explained the position of the United States on the subject.  He agreed  that there were disagreements on the facts, but 
that the issue was  subject to continued discussions between CPSC and AQSIQ.  Finally, he noted that 
since the last meeting, the CPSIA had recognised an  additional 20 laboratories based in China, which 
led to a total of 96 recognized laboratories based in China.  On the other hand, he noted that China 
does not recognise any US conformity assessment bodies.  
(ix) European Union – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152) 
209. The representative of the United States
  expressed serious concerns regarding the EU's 
accreditation framework set out in Regulation 765/2008.   He was concerned that the measure would 
leave recognition of non-EU accreditation bodies that are signatories to  ILAC (International 
Laboratory Accreditation Cooperation) and IAF (Intern ational Accreditation Forum) to the discretion 
of Member States.  The representative reiterate d concerns with statements from the European 
Cooperation for Accreditation (EA) as to potential actions  in this matter.  He hoped for a resolution to 
ongoing discussions between EA, ILAC and IAF con cerning consistency of Regulation 765/2008 with 
IAF-ILAC requirements, and again urged the Euro pean Union to provide clear written guidance as 
part of these discussions – clarifying that the measure would not impact recognition of non-EU 
accreditation bodies, as the European Union had st ated in previous TBT Committee meetings. 
210. The representative of Korea  shared the concerns of the Un ited States regarding the possible 
impact of the measure on recognition of non-EU accreditation bodies under the ILAC/MRA (Mutual  G/TBT/M/53 
 Page 39 
 
 
  Recognition Agreements) and the IAF/MLA (Mu ltilateral Recognition Arrangements). He also 
expressed concerns about acceptance of conformi ty assessment tests performed by ILAC and IAF 
member labs accredited by non-EU accreditation bodies.  He invited the European Union to ensure 
consistency with ILAC/MRA and IAF/MLA, and to provide updates on the Regulation. 
211. The representative of Australia  reiterated previous interventions on this issue, including with 
regard to the recognition of conformity assessment procedures from third parties.   
212. The representative of Thailand  marked her delegation's concern with the measure. 
213. The representative of the European Union  referred to responses in previous Minutes as these 
concerns essentially reiterated those that had been pr eviously raised.  He noted that his delegation had 
held a detailed bilateral exchange  with Korea on this issue, and he hoped that this had met their 
requirements.   
214. He informed the Committee of the most si gnificant recent developments regarding the 
implementation of the European accreditation framework: firstly,  on the relationship between the EA and ILAC and IAF, he informed that ILAC and IAF were in the process of peer-evaluating EA. 
Secondly, with regard to the activities carried out by EA, he clarified that one of its main tasks, as the 
official European accreditation infrastructure, is to harmonize accreditation practices across the 
European Union.  Current priorities for the EA were  therefore the training of lead assessors in peer-
evaluations, and enhancing the competence of assessors in each regulated sector.  He added that this 
required a great deal of coordination between, on the one hand, the EA and EU Member States' 
accreditation bodies and, on the other hand, the Member State authorities competent for the designation of Notified Bodies and for the appli cation of related product legislation.  The 
representative highlighted the importance of accreditati on bodies being in tune with market realities, 
in order to be able to assess the competence of  conformity assessment bodies to analyze specific 
products against EU regulatory requirements.  He not ed that EA has been developing a number of 
policies, and encouraged interested delegati ons to consult EA's website (www.european-
accreditation.org) to access guidance documents establishi ng its policy in its various fields of activity.  
He concluded with an invitation for further clarif ication through bilateral channels if necessary. 
(x) Canada – Bill C-32 amendment to Tobacco Act  
215. The representative of Mexico
 noted that a bilateral consulta tion with Canada had taken place, 
that Mexico intended to continue addressing its c oncerns regarding this Bill, and would therefore 
pursue additional bilateral consultations. 
216. The representative of Turkey  restated concerns expressed at the last Committee meeting, 
supporting the Bill's objective, but believing it to be  more trade-restrictive than necessary.  She 
explained that the restriction on the use of certa in additives in effect banned certain types of 
cigarettes, as these additives are essential components of traditional tobacco blends.  She argued that 
these additives do not give any characterizing flavours  to tobacco products and that the decision had 
been taken without consideration of their effects.   She added that blended and non-blended tobacco 
were like products, and any restric tion on additives would constitute de facto  prohibition of blended 
tobacco. 
217. She said that no scientific evidence supports e ither the suggestion that additives used in 
blended tobacco were attractive to consumers, or the view that blended tobacco products were more 
harmful to health and more addictive.  She view ed the measure as disproportionate, and hoped that the 
Canadian authorities would reconsider their decisi on and move towards a less-restrictive measure in 
accordance with TBT commitments.  G/TBT/M/53 
Page 40  
 
  218. The representative of Honduras
 shared concerns of other Members, citing Canada's 
obligations under the TBT Agreement and the impact  that this measure has had on Honduran tobacco 
exports to Canada.  Though accepting the legitimacy of the policy objective, she argued that the goal 
had been pursued through an overly restrictive measure.  She asked how the special needs of 
Honduras were addressed within the framework of  Article 12.3 of the TBT Agreement when 
preparing and applying the prohi bition on additives, and how the measure was compatible with 
Article 20 of TRIPS – the use of a trademark within the framework of commercial operations with specific demands, such as the use of an example th at would undermine the capacity to distinguish 
between the goods and services of one company and another. 
219. The representative of the Dominican Republic
 reiterated earlier interventions, again voicing 
concern over the adoption of this measure, which effectively prohibited the manufacture and sale of 
traditional blend cigarettes.  She appreciated the le gitimacy of the aim but shared the view that the 
application was too broad and dispro portionate, given the coverage of the preparation of products with 
a special flavour.  She argued that many component s are used in producing the three main types of 
tobacco, and that prohibition resulting from the Bill ha d significant impact given the use of blends of 
tobaccos to provide different flavours.  She repeated  her previous request for Canada to revise its law 
in compliance with the framewo rk of the TBT Agreement. 
220. The representative of Jordan  restated comments from previous meetings, supporting Canada's 
objective of protecting health but questioning the existence of scientific evidence supporting the ban 
on the additives listed in the Bill.  He also argued that no scientific evidence indicated that additives 
used in the production of tobacco made the product more  attractive than other types of cigarettes.  He 
viewed the measure as inconsistent with Ca nada's obligations under the TBT Agreement. 
221. The representative of Cuba  shared the concerns raised in  the preceding interventions.  He 
considered the Canadian measures to lack scien tific basis, as some banned components did not 
contribute any characteristic flavour to cigarettes.  He explained that Cuba considered the measure to 
be overly restrictive for the stated objective and hoped for a re-evaluation that would ultimately result 
in a less restrictive measure.  He argued that th e measure should not be based design characteristics, 
and pointed to measures adopted by Members that prohibited different highly aromatised products as 
examples in line with Article 2.8 of the TBT Agreement. 
222. The representative of Colombia  reiterated its position on the issue, particularly the need to 
discuss these measures in relevant and specialised fora, and avoid discriminatory measures defending 
a type of tobacco produced by a country. 
223. The representative of Chile  supported the aim of reducing tobacco consumption and 
protecting the health of young people, but underlined concerns that the measure  was more restrictive 
than necessary.  She suggested the various guidelin es of the World Health Organization (WHO) to be 
worthy of consideration, underscoring the necessity of scientific evidence. Furthermore, she noted that 
the Canadian measure concerned onl y one type of tobacco (Burley tobacco), placing it at a clear 
disadvantage compared with Virginia tobacco.  Sh e sought clarification of Canada's intentions 
regarding the measure, as it was not notified to th e TBT Committee, specifically if a revision or 
modification of the Bill was planned, as Members did not have the opportunity to comment prior to its 
application. 
224. The representative of Ecuador  restated previous systemic and commercial concerns regarding 
the measure, in particular that it constituted a de facto  prohibition of the import and 
commercialization of Burley tobacco cigarettes.  He stated that the measure was more restrictive than 
necessary and undermined Articles 2.2 and 2.8 of the TBT Agreement. 
225. The representative of the Philippines  reiterated previous concerns on the measure.  G/TBT/M/53 
 Page 41 
 
 
  226. The representative of Canada  explained that C-32 had been Canadian law since coming into 
effect on 5 July 2010.  No modifications were pla nned, but the concerns expressed by Members at all 
TBT Committee meetings had been noted.  In res ponse to questions, he observed that a number of 
questions had been answered in pr evious sessions and referred to the minutes of previous meetings for 
elaboration upon Canada's views on the scientific basis of the Bill and why it offered the best solution 
to the stated public health objective.  He explained th at the intent of this legislation had been to ban 
the use of certain additives which contribute to making tobacco products  more attractive to youth.  He 
noted that he was unaware of any cigarette brands  having been withdrawn from the market as a result 
of the measure since the last provision of this  amended Act came into force, and no Members had 
raised specific concerns regarding bilateral trade. 
227. He emphasised that the Act prohibited the u se of certain additives which contributed to 
making products more attractive to youth regardless of their origin and did not ban any type of 
tobacco or tobacco product.  He informed the Committee that Canada had met with a number of 
Members bilaterally during the past week, and over se veral preceding months; he offered to continue 
to do so and invited communications on any specific concerns. 
(xi) Thailand – Health Warnings for Alcoholic  Beverages (G/TBT/N/THA/332 and Add.1) 
228. The representative for the European Union  referred to the Minutes of the previous meeting 
and to the European Union's writt en comments on Thailand's notification.  She requested an update of 
the review of requirements announced in Octobe r 2010, which Thailand had stated would take 
account of concerns raised by WTO Members in wr iting and in past TBT Committee meetings.  She 
also asked for details on when this review woul d be notified to the TBT Committee, and when the 
European Union could expect a reply to its comments of March 2010. 
229. The representative of the United States  raised previously-aired concerns, including the 
scientific basis for the text of the alcohol warni ng requirements, the size of the warning label in 
proportion to the bottle, the requirement to rotate the warning statements every 1000 bottles and the 
proposed implementation period.  He hoped that the c oncerns which were set out in US comments, as 
well as in responses to Thailand's supporting study we re being taken into account, and noted that the 
United States had requested an update from Thailand.  
230. The representatives of Mexico , Australia , Canada,  New Zealand , and Chile , shared concerns 
raised by previous speakers, and sought an up date on the review process, including when updated 
measures would be notified to the TBT Committee. 
231. The representative of Thailand  informed the Committee that th e Thai Ministry of Public 
Health had set up a sub-committee assigned to st udy the impact of its regulations on alcohol 
beverages.  The sub-committee had yet to start its  work, but the scope of the study included the 
regulation on health warnings notified under G/ TBT/N/THA/332, and she said her delegation would 
keep the Committee updated on developments. 
(xii) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
232. The representative of the European Union  reiterated concerns on the proposed requirements 
on the transport of lithium batteries in the Hazar dous Materials Regulations as far as they went 
beyond United Nations Recommendations on the trans port of Dangerous Goods and the Technical 
Instructions on the Safe Transport of Dangero us Goods of the International Civil Aviation 
Organization (ICAO).  She referred to the minutes of  relevant Committee meetings in 2010 for more 
information on these points, and requested informa tion on the state of play, as discussions on this 
proposal appeared to be ongoing. G/TBT/M/53 
Page 42  
 
  233. The representative of Japan
 expressed concerns over restrictions on transportation of lithium 
batteries from the US, arguing that inconsistency with United Nations recommendations on transport 
of dangerous goods and ICAO Technica l Instructions would impact upon tr ade.  In addition, he stated 
that there should be no regulations targeting goods as sured of safe transport.  He anticipated that the 
final ruling was imminent, and asked the United St ates to give full consideration to the opposing 
views expressed by many governments and private en terprises. He asked that in terms of safety, 
lithium ion batteries with low State of Charge (SOC ) should be exempted. Finally, he noted that the 
United States Department of Transport website10 stated that the effect of the regulation would be 
significant, and hence he sought detailed informatio n about the foreseen dates of notification to the 
TBT Committee. 
234. The representative of China  understood that the primary goal of the regulation was to ensure 
the safety of flights carrying lithium batteries, and argued that the current United Nations regulation 
has proved, globally, to be effective enough to ensure  flight safety in recent years – thus rendering the 
formulation of stricter regulations unnecessary.  
235. The representative of Korea  explained that concerns over the lithium battery regulation had 
been expressed in bilateral meetings with the United States, including a delegation to the United 
States to meet Office of Management and Budge t (OMB) officials and ra ise the issue of lithium 
batteries.  He noted that no update on the progress of the regulation had been received and advised the 
United States to follow the UN r ecommendation and ICAO regulation. 
236. The representative of the United States  explained that discussions with the regulator and 
OMB were on-going.  He noted that a bilateral me eting with Japan, similar to the aforementioned 
with Korea, had taken place since inviting interested  Members to engage bilaterally.  He added that 
there was as yet no timetable for the publication of  the final regulation, and to his knowledge, no new 
proposed regulations in this area had been made.  When, or if, there were new proposed regulations 
that would be potential TBT measures, he assure d the Committee that they would be notified. 
237. Addressing the issue of ICAO and UNECE standards, he argued that this issue should never 
have come before the TBT Committee, and should ha ve been dealt with in ICAO and UNECE.  In his 
opinion, the fact that these bodies were not fo llowing the TBT Committee decision principles for 
developing international standards had caused the problem facing the Members.  He elaborated upon 
the functioning of these organisations, stating that  developing countries were largely excluded from 
participating in development processes, decisions we re not based on consensus since the EU Member 
States constituted a voting majority and came to a position ahead of meetings, which effectively 
excluded the views of others.  He suggested that if these two bodies were following the TBT 
Committee decision principles, it would be more like ly that our regulators, and their experts in 
batteries and aircraft safety, would have been able to reach a sufficient resolution in their technical 
committees, and this issue would not have reached   the TBT Committee.  He reasoned that not 
adhering to the Committee Decision principles  cau sed many issues for the Committee and following 
its principles could help ensure that consensus st andards would be developed in these bodies and more 
likely to be used by all parties concerned.  He hoped that this experience would lead ICAO and 
UNECE to review their principles for standards de velopment, and to make changes to reduce the 
likelihood of similar occurrences in future. 
(xiii) Brazil – Alcoholic Beverages (G/TBT/N/BRA/348 and Suppl.1) 
238. The representative of the European Union  requested an update on the state of play, having 
been informed at the last TBT Committee meeti ng that Brazil was in the process of reviewing 
                                                      
10 http://www.dot.gov/ .  G/TBT/M/53 
 Page 43 
 
 
  responses to its public consultation and TBT notificati on.  She also requested an indication of when a 
draft proposal was likely to be made available. 
239. The representative of the United States  stated that comments had been submitted prior to the 
last meeting, which went into detail on many que stions and concerns, including the treatment of 
abbreviations, illustrations on labels, registra tion numbers, certain font requirements, and 
implementation periods.  He asked for an update on the process for taking these, and other concerns, 
into account in the publication of the final measure. 
240. The representative of Mexico  also requested an update on the state of play, and enquired as to 
whether or not previous comments ha d been taken into consideration. 
241. The representative of Brazil  informed the meeting that the Brazilian authorities were still in 
the process of examining comments received on its dr aft regulation on bevera ge labelling, and assured 
Members that their comments would be taken into account before publication of the final measure.  
He emphasised that the draft measure had the leg itimate objective of guaranteeing an adequate level 
of protection and information to consumers, wit hout creating unnecessary obstacles to the regular 
flow of beverage e xports to Brazil, and the requirements laid down in the draft regulation would apply 
equally to domestic and imported alcoholic beverages. 
242. Referring to questions raised in previous TB T Committee meetings concerning the obligation 
of including an import identification number on the la bel, he explained that this requirement aimed to 
adequately protect consumers, as information c oncerning the importer was crucial in establishing 
legal responsibility.  He clarified that labels would not necessarily require redesign for the Brazilian 
market, as the import identification number and othe r mandatory information could be included on a 
supplementary label.  He reaffirmed that the prohi bition of illustrations would not impede the use of 
established trademarks, and restriction of use on te rms such as "home made", "reserve" and "colonial" 
were designed to protect consumers from being misl ed as to the quality of the products.  Finally, he 
welcomed further discussions through bilateral channels  for clarification of other specific issues, and 
stated that no forecast had been made for the publication of the final version of this measure. 
(xiv) Turkey – New Conformity Assessment Procedures for Pharmaceuticals  
243. The representative of the European Union  restated concerns with regard to Turkey's Good 
Manufacturing Practices requirements for pharmaceu ticals, which entered into force on 1 March 
2010.  She reiterated that in order to obtain an  EU Good Manufacturing Practice (GMP) certificate, 
EU manufacturers were already inspected by the comp etent authorities in EU member states to verify 
compliance with good manufacturing practices.  She said that Turkey had yet to offer any indication 
as to whether any problems had been encountered w ith EU GMP-certified products on its markets.  In 
this context, she urged Turkey to revert to rec ognition of EU GMP standards and certificates without 
additional factory inspections and a dditional administrative requirements. 
244. The representative of the United States  expressed concerns similar to those raised in previous 
meetings on the lack of transparency in the de velopment and implementa tion of this, and other 
measures, by Turkey.  He explained that the Unite d States was not against inspection requirements in 
principle, but the manner of implementation had caused  significant market disruption, to the detriment 
of both US exporters and Turkish consumers.  He urged the Govern ment of Turkey to consider 
measures to alleviate the blockage of imports of  pharmaceuticals, including processing registration 
files submitted prior to March 2010, giving priority to innovative drug applicat ions that provided new 
therapies and allowing producers to submit an app lication while GMP inspections were pending.  He 
hoped to hold further technical discussions with Tu rkey to discuss these issues  and resolve concerns 
in the near term, restoring market access for pharmaceuticals. G/TBT/M/53 
Page 44  
 
  245. The representative of Turkey
 stated that the general requirements for the manufacturing of 
pharmaceutical products were first introduced in 1984 , and its Ministry of Health began conducting 
GMP at the national level in 1995, and therefore Turk ey had considerable experience in this field.  
She explained that the document required its licen sing application for pharmaceutical products.  She 
explained that the aim of the regulation was to pr otect human health through the provision of safe 
pharmaceutical products. 
246. Citing the preamble of the TBT Agreement, sh e said that no country should be prevented 
from taking measures necessary to ensure the protec tion of human health. Gi ven that pharmaceutical 
products are concerned with human health, and that  the aim of this measure was the protection of 
public health, she argued that it was consistent w ith WTO rules and in accordance with the relevant 
guidelines and recommendations of the WHO.  She a dded that Turkey's system did not envisage any 
restrictive effect of additional administrative burden for importers, and that its Ministry of Health had 
accepted and processed applications for GMP certificat es.  She informed the Committee that of the 
complete applications received, four had been pr ocessed and completed, and another five complete 
applications were in process. 
247. Finally, the representative also explained that  the Ministry of Health was developing a 
classification system for pharmaceuticals based on scientific criteria.  Additionally, she urged 
Members to consider the option of an MRA, and sa id that Turkey remained willing to continue to 
communicate and work constructively with interested Members. 
(xv) Italy – Dairy products (G/TBT/N/ITA/13)  
248. The representative of New Zealand  reiterated concerns on th e Italian proposal on dairy 
products.  She argued that it was inconsistent with relevant international st andards and Codex, and 
that the stated objectives were al ready sufficiently covered by EU law.  She requested an update on 
progress and asked for confirmation of the European Commission's opinion as to whether the proposed ban on protein would be c onsistent with EU law provided  it applied to Italian products 
alone. 
249. The representative of Australia
 shared New Zealand's concerns over this measure, particularly 
Article 5, which proposed a ban on the use of milk  protein concentrate (MPC) in cheese making.  He 
sought an explanation from the European Commis sion on the legitimate objective under which such a 
measure could be justified.  He said that Austra lia was unaware of any scientific evidence of Chile 
using MPCs of insufficient nutritional value or in any non-compliant with food safety and public 
health requirements.  He asked for an update on discussions between the European Commission and 
Italy on this measure. 
250. The representative of the European Union  informed the meeting that discussions between the 
European Commission and the Italian authoriti es on the proposed measure were ongoing, and 
therefore remained an internal procedure.  She did offer further clarification for any interested 
delegation once the internal cons ultation process had concluded. 
(xvi) European Union – Directive 2004/24/EC on Tr aditional Herbal Medicinal Products 
251. The representative of India  requested an explanation of the rationale behind the decision to 
not notify the enactment of EU Directive 2001/83/ EC relating to medicinal products for human use 
and the subsequent Directive 2004/24/EC on traditi onal herbal medicinal products (THMP).  He 
explained that the requirement to provide exte nsive documentary evidence on physiochemical, 
biological, micro-biological and pharmacological tests, as well as data on quality and safety 
requirements for the purposes of obtaining marketing authorization or registration (under the 2001 
Directive or the 2004 THMP Directive respectively)  may be unnecessary obstacles to trade, may not  G/TBT/M/53 
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  be based on scientific principles and may be mainta ined without sufficient sci entific evidence.  He 
expressed concern that the Directive was excessive  and not limited to what could be deemed 
reasonable and necessary, in effect denying market access to India's ayurvedic products. 
252. He argued that the current THMP Directive requirements had set out a complex procedure for 
registration of multi-ingredient prod ucts, given that a complete dossier is required for registration;  
polyherbal products may pose special problems as in such cases the quantification (and stability 
testing) of each component was not possible for practical reasons. 
253. He thought that the Common Technical Document (CTD) format under the THMP Directive 
seemed acceptable for single herbs, but possibl y inappropriate for multi-component traditional 
medicinal formulations.  Furthermore, he stated  that it could be near impossible to provide 
information with respect to multi-component traditi onal medicinal formulations in the CTD format, 
even if the products were otherwise eligible as TH MP.  He argued that the 2004 Directive therefore 
imposed a de facto  ban on imports of such products and ma y be inconsistent with GATT Article XI. 
254. He said that toxicity data should be required on a case-by-case basis, e.g. where there is 
reason to believe that the herb may be toxic or th ere is an alert on the herb.  Data should not be 
required across the board for herbs known to be gene rally safe, that are included in the Generally 
Recognised as Safe (GRAS) list.  Requirements on ge ontoxicity data and bioessays of ingredients in 
poly-herbal formulation had apparently resulted in  low numbers of applications for traditional-use 
registrations.  He argued that insistence on quantit ative determinations (bio assays) in polyherbal 
compounds was technically unfeasible for any polyherbal  formulations with more than three or four 
ingredients – further insistence on genotoxicity data without hazard assessment indicated the 
excessiveness of the Directive.  
255. He explained that a large number of traditiona l herbal medicinal producers were small and 
medium-sized enterprises and the prohibitively high  cost of registration under the Directive would 
create a barrier to market access fo r such enterprises.  These costs co mprised analytical and galenical 
development, stability testing, dossier compilation and dossier submission.  He cited estimates in the 
range of more than €150,000 for a single ingredient product. 
256. He stated that the EU Directive did not rec ognise ayurvedic products that complied with the 
provisions of the Ayurveda Pharmacopoeia of I ndia, which were certified by bodies accredited by 
members of ILAC/IAF Mutual Recognition Agreements .  In addition he explained that the scope of 
the THMP Directive was limited to herbal produc ts, and many ayurveda, siddha and unani products 
contain a combination of ingredients which were of  mineral and animal origin, yet these were denied 
registration.  He requested an update on the status of these products under the Directive. 
257. He raised the issue of a supplier being required to show 30 years of traditional use, including 
15 years of traditional use in the European Union in order to establish efficacy of the medicinal 
product.  He postulated that this  requirement would prove so difficult to fulfil that it would be a de 
facto  ban on imports of THMPs, thereby resulting in a co mplete denial of market access.  He said that 
Article 16(c)(4) of the 2004 Directive prescribed an alternate process of a Committee referral for 
seeking registration of traditional herbal medicinal products, when the product had been in use in the 
European Union for less than 15 years.  Howe ver, the guidelines and parameters on how the 
Committee would assess the product were not detailed.   He argued that the derogation [from the 
requirement of demonstrating 15 years prior use in  the European Union] indicated that the condition 
of 15 years prior use was not sacrosanct and may not  have been based on scientific evidence – and as 
such had no rational justification. 
258. He asked if the EU had considered alterna tive methods or procedures for ascertaining the 
safety, quality, and efficacy of traditional medici nal products, including THMP while formulating its G/TBT/M/53 
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  procedures under the 2001 and 2004 Directives.  He requested clarification of the classification of 
herbal medicinal products under the 2004 Directive, as it provided for the registration of over-the-
counter products, and also on the status of marketing of other herbal products outside this category.   
259. Under these circumstances, he asked the Europ ean Union to extend its transitional period by 
another ten years; the existing transitional period of the Directive would end in March 2011, after 
which it would come into force. 
260. The representative of China
 shared India's concerns, but acknowledged the European Union's 
openness on the issue. 
261. The representative of Ecuador  shared the points raised in previous interventions.  As already 
stated in previous meetings, he explained that  Ecuador exported medicina l products based on herbs 
and the requirements of these Directives (namely chemical, microbiological and pharmabiological 
evidence, as well as details and data  on quality and safety) for import authorisation and EU market 
registration would be excessively costly and diffi cult to comply with, especially for small and 
medium-sized enterprises in developing countries.   He added that herbs from Ecuador would be 
particularly affected, and that the process of the wording and implementation of this Directive would 
constitute a barrier to trade under Articles 2.9.1 and 2.9.2 of the TBT Agreement. 
262. The representative of the European Union  noted that bilateral discussions had taken place in 
the past with some of Delegations, and offered to continue providing information in further meetings.  
She recalled that Directive 2004/24/EC introduced a simplification for the registration of traditional 
herbal medicinal products – if a product was eligible for simplified registration, the manufacturer was 
exempted from providing a number of tests and clin ical trials which were otherwise required under 
the standard procedure.  She stated that elig ibility for the simplified procedure was dependent upon 
usage over a period of 30 years, including at least 15 years within the EU.  She added that this could 
be demonstrated via bibliographical or expert ev idence and it was accepted that "medicinal use" did 
not exclusively mean "use as an authorised medicinal product", this proof of 15 years medicinal use in the European Union may be submitted even in  the absence of marketing authorisation. 
263. Expanding upon this point, she said that herbal  medicines may contain toxic substances that 
would be harmful for patients, despite being natu ral products.  The 15 years use in the European 
Union requirement allowed sufficient monitoring of side effects, increasing confidence in the absence 
of tests and trials.  However, she explained that if the 15 years requirement was not met, but the product was otherwise eligible for simplified regi stration, the product should be referred to the 
Committee for Herbal Medicinal Products for the elaboration of a monograph.  Once a monograph 
was completed, the manufacturer would not have to  demonstrate 15 years of use – this requirement 
therefore did not constitute an obstacle to bene fitting from the simplified procedure.  The 2004 
Directive foresaw a transition period of seven year s for manufacturers to submit registration requests 
for their products to the relevant authorities. 
264. She clarified that as of March 2011, herbal medicinal products not authorised or registered 
could no longer continue to be placed on the EU ma rket, however, herbal products may be classified 
and placed on the market as food products provided that they did not fulfil the definition of medicinal products and complied with applicable food la ws.  She cited Directive 2002/46/EC on food 
supplements and Regulation (EC) No. 1924/2006 on nutrition and health  claims made on foods as the 
relevant legislation concerning herbal products  marketed in the form of food supplements. 
265. Finally, she said that the European Commission had started an internal review process in 
2008, on the registration of traditional herbal medici nes.  This had concluded with the drafting of a 
report which expressed the European Commission's pr eparedness to consider extending the simplified 
registration procedure to products containing substances other than he rbal products, and that more  G/TBT/M/53 
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  experience with and information on the requirement of at least 15 years use had to be gathered with a 
view to assessing its necessity.  Any of these changes would require legislative action. 
(xvii)  Colombia – Shelf life Requi rements for Milk Powder 
266. The representative of the European Union  reiterated concerns on the adopted measure, which 
required imported milk powder to have a minimum shelf life of at least 12 months, 6 months more 
than the previous requirement.  She expressed concern that this extension would harm exports of milk 
powder to Colombia.  Given a combined transport a nd quarantine time of two months on average, if 
shelf life is counted from the date of commercialisa tion, export of the product would be  practically 
impossible without incurring additional costs to exte nd the shelf life of the milk powder via specific 
and costly treatments.  She explained that the Eur opean Union had invited Colombia to clarify several 
elements of this proposal at the last Committee meeting, particularly what risk the authorities  
intended to address by the extension of the shelf-life requirement.  She said that this query remained 
unanswered and requested further inform ation from the Colombian representative. 
267. The representative of the United States  encouraged Colombia to notify the measure, and 
requested clarification on the 12-month shelf life requirement for these products. 
268. The representative of Colombia  explained that the measure had recently been notified as an 
amendment to a previously notified decree, in G/TBT/N/COL/67/Add.3 on 27 Jan 2011.  The new decree extended the shelf life for m ilk powder, as well as the process of the product in Colombia.  He 
noted that comments on the notification had been included on 3 April 2011, and that no comments had yet been received from Members on the draft r esolution.  Finally, the representative emphasised 
that his delegation had previously responded to  the concerns of Members regarding potential 
discrimination of this measure. 
(xviii)  China – Regulations of the PRC on Certifica tion and Accreditation (promulgated by Decree 
No. 390 of the State Council of the PRC on 3 September 2003 
269. The representative of the United States
 reiterated concerns that China does not permit US 
suppliers to use competent conformity assessment  bodies, including test labs, product certifiers and 
inspection bodies, located outside Chinese territory to demonstrate compliance with its compulsory 
certification requirements.  He raised concerns fo llowing an indication in an earlier intervention that 
these requirements could be extended to other pr oducts through China's Restriction on Hazardous 
Substances (RoHS), as at least 20 per cent of US expor ts to China were currently affected by these 
issues with respect to conformity assessment. 
270. He said that numerous US industry interest s; including medical devices, information 
technology, the US Chamber of Commerce, US-Chi na Business Council and the telecommunications 
sector had submitted a letter to the USTR and ot her US agencies, listing conformity assessment and 
the lack of recognition of bodies outside China as one of the top issues facing US exports to China.  
He argued that requiring China Compulsory Certifi cation (CCC) related procedures to be performed 
by a single Chinese conformity assessment body often led to the imposition of additional costs, 
burdens and delays on US exporters, particularly SMEs.  He cited Decree 390, stating that in each 
area there should be at least two certification bodies, yet in many cases only one existed and none of them were located outside China – US companies we re thus obliged to arrange and fund travel for 
pre-market inspections at the manufacturers location,  submit to subsequent annual inspections after 
receipt of the CCC mark and also pay for product t esting and certification, which would already have 
been done in the United States. 
271. He explained that there were also issues with  changes in requirements and inconsistent post 
market surveillance, which were ra ised during a bilateral meeting he ld in the margins of the last G/TBT/M/53 
Page 48  
 
  Committee meeting.  He added that the US had b een encouraged to arrange a meeting with the 
Certification Accreditation Administration of the Pe ople's Republic of China (CNCA) during its last 
visit to Washington, but the CNCA had been unwilling, leading to the issue continuing to be raised in 
the Committee.  He said that the United States fa voured bilateral discussions, and hoped that China 
would consider ILAC and IAF as the basis for r ecognising Conformity Assessment bodies.  He noted 
that the Chinese Accreditation Authority under ILAC rules had a duty to promote the use of the ILAC 
MRA in China, and enquired as to what steps had b een taken towards this goal.  He compared this 
situation to the US Consumer Product Safety Comm ission’s recognition of 96 bodies based in China, 
stating that this growing disparity would increase th e seriousness of the issue – he hoped that China 
would start to recognise US conformity assessment bodies in the near term. 
272. The representative of China
 invited interested Members to review the Minutes of previous 
TBT Committee meetings for detailed clarificati on of the CCC scheme as this was a longstanding 
topic of interest.  However, he sought to clarif y the accreditation of foreign laboratories under the 
CCC scheme.  First, he explained that the Ch inese CCC system was a ma ndatory market access 
requirement in terms of conformity assessment procedures, rather than commercial inspection and 
certification, and therefore different in nature from third-party inspection required in the US CPSIA.  
Second, the Chinese CCC system facilitated trad e by allowing foreign conformity assessment bodies 
to participate in the implementation of the CCC system through mutual recognition agreements and 
multilateral systems.  He added that China ha d recognised 168 conformity assessment bodies under 
CCC, including foreign conformity assessment bodies su ch as the UL laboratory of the United States. 
Furthermore, China automatically accepted all test ing results of CB laboratories located in other 
countries, including the United States. 
(xix) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels 
273. The representative of the European Union  raised concerns with Korea's requirements for 
certification of photovoltaic panels, in particular th e standard for thin-film solar panels, which did not 
allow certain types of thin-film solar panels to be t ested or certified.  She explained that this prevented 
such technology from qualifying for govern ment incentive schemes – which was a de facto  ban from 
the market.  She added that the European Union had been engaged in bilatera l discussions with Korea, 
though there was no significant progress to be re ported.  She requested an update on a study 
undertaken by the Korea Energy Management Cor poration (KEMCO) on the environmental impact of 
thin-solar panels other than those using amorphous  silican (A-Si), and the foreseen timeline for the 
completion of the study. 
274. The representative of the United States  referred to past interventions discussing concerns with 
the KEMCO process for certification and the fact that  the Korean standard for thin-film solar panels 
only applied to a certain type of solar panel.  He not ed that the only type of thin-film panel that could 
be certified by the Korean Energy Management Corporation was manufactured by Korean firms, and those manufactured by foreign companies were not c overed by the standard – thus they were unable 
to gain certification and access the Korean market.  He said that the United States was not aware of 
any scientific or technical evidence indicating a risk from use of thin-film solar panels not covered by 
the Korean standard.  He explained that the alle ged concern was over the presence of cadmium in the 
panels or their production process, but argued that th e concentration levels were lower than regulatory 
levels and also lower than cadmium levels in batte ries on the Korean market.  He questioned the need 
to delay certification while working on a feasibility study assessing the safety of thin-film solar panels 
and urged Korea to amend its standard  and enable all thin-film panels to demonstrate that they met the 
requirements for certification. 
275. The representative of Korea
 reiterated that KS and its related certification were not 
mandatory;  any cadmium telluride (CdTe) and Copper Indium Gallium Selenide (CIGS) were 
allowed to enter the Korean market without KS certi fication.  He stated that  other Members had been  G/TBT/M/53 
 Page 49 
 
 
  notified at the last Committee meeting, and that  the feasibility study was ongoing, with publication 
expected by June 2012.  Following completion of th e study, he explained that the MKE would decide 
upon the inclusion of the aforementioned thin-fi lm panel types in KS61646, and subsequently 
Members updated. 
(xx) China – Textiles (G/TBT/N/CHN/20/Rev.1) 
276. The representative of the European Union  reiterated concerns, specifically with regard to 
mandatory requirements concerning pH values, le vel for colourfastness and odour of textiles, 
referring to the Minutes of past meetings for deta ils.  She thanked China for additional information 
submitted in writing in February 2011, but expressed disappointment at the lack of accompanying 
scientific evidence to support these mandatory requ irements.  Without these, she explained that it 
appeared that these measures had no scientific basis. 
277. The representative of China  stated that the revision of the national standard on textiles was 
notified to the TBT Committee on 10 February 2010.  He welcomed the EU's comments, dated 16 
April 2010, 3 September 2010 and 13 January 2011, noting that China endeavoured to issue detailed 
written responses.  He added that the last reply ha d included the details of a contact person, with a 
view to engaging in a more in-depth technical exch ange.  He invited the European Union to refer to 
this person directly on technical matters and clar ification of the new standard.  He informed the 
Committee that the standard had been approved and published on 14 January 2011 and would be in 
force from 1 August 2011. 
(xxi) India – New Telecommunications related Rules 
278. The representative of the European Union  thanked India for making available their experts to 
discuss with the European Commission and EU industr y concerns with the above mentioned rules.  
Meetings held in Delhi built a shared understanding of the rules, and also helped elaborate her 
delegation's concerns. 
279. He recalled that in March 2010 the Department of Telecommunications of the Indian Ministry 
of Information and Communication Technology, ha d published new rules on security clearance for 
telecommunications equipment.  Subsequently, in July 2010, a mandatory template agreement for 
security and business continuity had been issued, wh ich formed part of private commercial contracts 
between telecommunication service providers a nd vendors of all telecommunication related 
equipment, products, and services. 
280. The representative further recalled that his delegation had expressed a number of concerns 
with the template agreement at the past TBT Committee meeting and in a number of subsequent 
bilateral meetings.  The concerns included:  (i), the obligation that vendors deposit their source code 
in an escrow account that would be accessible to officials from the Department of Telecommunications; (ii), the mandatory transfer of  technology to Indian companies;  (iii), the 
unlimited liability foreseen on vendors in case of any security breach;  (iv), the requirement to 
substitute Indian engineers for foreign engineers fo r the maintenance of networks;  and, (v), the 
apparent exemption of telecomm unication equipment and products manufactured in India from the 
application of the new rules, meaning that only imported equipment and foreign vendors would be 
covered.  He also noted that the since the te mplate agreement mandated compliance with specific 
security standards, as well as testing and certificat ion requirements, it was in his delegation's view 
both a technical regulation and a conformity assessment procedure within the meaning of the TBT Agreement. 
281. He reported that in August 2010 the Indian Pr ime Minister's office had decided to give 
telecommunication operators a choice between complia nce with either a security clearance on a case-G/TBT/M/53 
Page 50  
 
  by-case basis according to a self-declaration system  subject to assessment by the Department of 
Telecommunications, or the new system of prior security clearance based on the rules of the new template agreement.  The dual regime had been initially granted for a period of 60 days, and then 
extended for additional 60 days, and subsequently  had been extended on 14 March 2011 until further 
notice, pending review of the new security  clearance policy by the Department of 
Telecommunications, in light of the concerns rai sed by foreign partners.  The representative expressed 
his delegation's appreciation for the extension of th e dual regime, since it created a more predictable 
framework for the business community and for trade in these products, as well as, more generally, for 
India's commitment to finding a solution capable of fulfilling its legitimate security needs without 
restricting international trade. 
282. Finally, the representative requested an update on the timeline and content of the 
aforementioned policy review by the Departme nt of Telecommunications, inquired whether a 
stakeholder consultation was foreseen, and requested  that the revised draft be notified to the TBT 
Committee.  Lastly, he reiterated his delegation's availability for discussion and experience sharing 
with the competent Indian authorities in the fra mework of the India-EU bilateral ICT dialogue. 
283. The representative of the United States
 recalled that his delegation had, at the last TBT 
Committee, described the Indian measure and prov isions of the template  agreement that would 
become a mandatory element of commercial cont racts between telecommunication service providers 
and vendors of all telecommunicati on related equipment, products and services.  He noted several 
concerns with the measure raised by US industry, including the requirement that companies deposit their source codes in escrow, mandatory technology transfer to local telecommunication companies, 
and burdensome and irrelevant tes ting and certification requirements. 
284. He understood that the government of India w as considering eliminating the requirements for 
the provision of source code and technology transfer, and revising other portions of the regulation, to 
address concerns raised by trading pa rtners and industry.  He requested an update on the current status 
of the measure, and inquired whether a revised templa te agreement would be forthcoming; if so, he 
requested that the revised agreemen t be notified to the TBT Committee. 
285. The representative recalled that India had argued at the November 2010 Committee meeting 
that the measure was not subject to the TBT Ag reement, since its objective was national security. 
However, he noted that Article 2.2 of the TBT Agreement specifically listed national security as a legitimate objective, and he therefore expressed the view that the measure was covered by the TBT 
Agreement and subject to its disciplines, including no tification, which he believe d to be appropriate in 
this case. 
286. The representative of Japan
 expressed concern with the possible security related amendments 
to the unified access service licence agreement, and supported the inte rventions of the EU and US 
delegates.  He highlighted the requirements for t echnology transfer from foreign to domestic firms, 
and for deposit of source code in escrow, as contrary  to WTO rules for the protection of intellectual 
property rights, and harmful to foreign fi rm's ability to access the Indian market. 
287. He explained that Japan shared Indian's comm itment to ICT network security, and understood 
its importance for both the business sector and nationa l security.  However, he noted concerns with 
implementation of the measure, and he encourag ed India to take full account of the problems 
identified by concerned industry.  Finally, he reca lled that in mid-February his delegation was led to 
believe that the proposed amendments to the unifi ed access service licence agreement would shortly 
be made public, and he requested an update as to the latest developments. 
288. The representative of China  echoed the concerns raised by the EU and US delegates.  He 
expressed support for India's objective of telecommunication security, but was concerned about the  G/TBT/M/53 
 Page 51 
 
 
  vague certification environment and the standards ela borated within the Indian rules.  He called for 
greater transparency, and requested an opportunity for stakeholders, including equipment vendors, to comment on the measure.  Finally, he emphasized that  all vendors should be treated fairly under the 
rules, in accordance with the pr inciple of non-discrimination. 
289. The representative of India
 reiterated his delegation's belief th at the provisions of the unified 
access licence agreement for telecommunication services were not a technical barrier to trade within 
the ambit of the TBT Agreement.  Rather, he said that the provisions fell within the security 
exemptions of Article XXI of GATT 1994, and the TBT Committee was therefore not an appropriate 
forum for discussion. 
290. He did, however, refer to the concerns related to  technology transfer.  He noted that transfer 
of technology was an integral element of intern ational agreements, and also a key element of 
technological development in developing countries and LDCs.  He recalled that both the Doha 
Ministerial Declaration and the Hong Kong Minist erial Declaration recognised the importance of 
technology transfer in the context of trade.  He  also reminded Members that the TRIPS Agreement 
recognized transfer of technology as one of the objectives under Article 7, and in Article 66, an 
obligation was placed on developed country Member s to provide incentives to  their enterprises and 
institutions that promote and encourage technolog y transfer.  He reiterated the importance of 
technology transfer for technological development, a nd stated that, in the view of his delegation, it 
was a central parameter of the measure under discussion. 
291. Finally, he informed the Committee that the Department of Telecommunications was working 
to simplify the procedural aspects of the licensi ng agreement.  He noted requests for additional 
information from the European Union, United States,  Japan and China, and he pledged to consult 
capital and revert to the requests at the next Committee meeting. 
(xxii)  Brazil – Instructions for Registration for Labe ls of Imported Products of Animal Origin 
(G/TBT/N/BRA/385 and Adds 1 and 2) 
292. The representative of the United States  expressed its gratitude to Brazil for responding to the 
comments submitted by the United States on this issue in November 2010.  He reported that the 
United States greatly appreciated Brazil's willingn ess to address the United States' concerns by 
amending the registration form for labels of imported products of animal origin.  In addition, he noted 
that Brazil and the United States continued to ha ve constructive discussions in this regard, and 
expressed its impression that Brazil was keen to c ontinue to cooperate with the United States to 
clarify the United States' remaining concerns on this  issue.  Finally, he expressed the United States' 
interest in holding a meeting between the technical  experts of both countries, especially considering 
that Brazil's measure was to enter into force on 1 April 2011. 
293. The representative of the European Union  expressed her delegation' s concern regarding the 
need to register the labels of products of animal origin and have them appr oved before they could be 
marketed in Brazil.  She stated th at the European Union continued to  monitor the situation to ensure 
that this requirement was not creating unn ecessary delays and costs for EU exporters.  
294. The representative of Brazil  informed the meeting that the proposed measure had been 
reviewed at the end of 2010, taking into account the comments received from other Members on the issue.  Additionally, he reported that the deadlin es to comply with the new requirements had been 
extended and expressed his hope that these modifica tions would help to alleviate some Members' 
previous concerns. G/TBT/M/53 
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  (xxiii)  Indonesia – Labelling Regulations (Minist ry of Trade Regulation 62/2009 and 22/2010) 
(G/TBT/N/IDN/47) 
295. The representative of the European Union
 thanked the delegation of Indonesia for notifying to 
TBT Committee the regulations of the Indonesian Ministry of Trade concerning the obligatory labelling of goods, allowing other Members to submit comments in this regard within a 60-day period.  
She noticed however, that these regulations had already en tered into force at the time of this meeting.  
She also expressed her delegation's hope that the European Union's written comments sent on 3 
February 2011 would be taken in to account and that the regulati ons were going to be revised, if 
necessary.  She recalled that during the previous  TBT Committee meeting, the European Union had 
requested a clarification about why imported products  could not be labelled or  re-labelled in Indonesia 
before they were actually placed on the market and why a preapproval procedure of the label was 
considered necessary.  
296. She added that the European Union had also as ked for clarification regarding the exemption 
procedure for importers.  She noted that Indonesia ha d replied to this request by explaining what these 
regulations were providing for, but that it had no t given any explanation as to why these requirements 
were deemed necessary.  Thus, she expressed her de legation's hope that this  explanation could be 
provided during this TBT Committee's session, as well as in a written reply to the request sent by the 
European Union. 
297. The representative of the United States
 observed that his delegation had similar concerns, and 
that in the United States' view Indonesia's labelling measure as currently drafted could significantly disrupt trade.  He expressed his delegation's respect  for Indonesia's desire to have all packaged food 
and many industrial products sold at the retail leve l bearing a label in Indon esian language.  He added 
that the United States hoped to continue working with Indonesia to resolve this issue, in particular 
concerning the question of whether a supplemental labe l could be applied post-customs.  He indicated 
that due to the rise of global supply chains and th e use of consolidated shipments, it would be very 
costly and burdensome for compani es if the label were required prior to the shipment of the products 
to Indonesia.  He suggested instead that, for inst ance, supplementary labels could be applied at the 
importers selected warehouse in an in-country lo cation, after the product had cleared customs but 
prior to distribution within Indonesia.  He stated that this would be the best way forward, recalling 
that this was also the way Indonesian pr oducts were allowed into the US market. 
298. The representative of Indonesia
 took the floor and explained that the Ministry of Trade of the 
Republic of Indonesia Regulation No. 62-22-2010 was aimed at ensuring consumers' right to obtain 
correct, clear and precise information, as well as provi ding consumer protection.  He explained that 
the intention of the Indonesian authorities was not to create any trade barriers or increase costs for 
importers.  Rather, their intention was to addr ess the risks arising from the practice of labeling 
products after port entrance, but before being placed on the Indonesian market.  He also explained 
that, for instance, the measures included exemptions fo r goods that were packaged directly in front of 
the consumer, and for goods listed in Attachments 2 a nd 3 of the regulations.  He finally stated that 
his delegation would welcome further discussions with EU and US on this matter at a bilateral level. 
(xxiv)  European Union – Proposal for a Council Regul ation on the Indication of the Country of 
Origin of Certain Products Imported fr om Third Countries (SEC(2005)1657)   
299. The representative of the United States  recalled that at the last Committee meeting, his 
delegation noted that the EU Parliament had recently  voted to approve a proposal of the Parliament 
and Council regulation on the indication of the c ountry of origin on certain products imported from 
third countries, which would require that certain c onsumer products imported from third countries be 
labelled with their country of origin.  He added th at the list of specific products that required marking 
was in the opinion of the United States' very broa d.  He indicated that the United States acknowledged  G/TBT/M/53 
 Page 53 
 
 
  that there could be legitimate reasons for requiring country of origin labelling.   However, he added, 
these regulations should not discriminate based on orig in, observing that the draft of the EU measure 
appeared to only require products imported from thir d countries to be labelled.  Thus, he indicated, 
products from the EU as well as Turkey and member s of the EEA agreement would be excluded from 
the country of origin labelling requirement.  In the view of the United States, such requirement should 
not apply only to imported goods or only to import ed goods of some countries.  Therefore, he 
requested a clarification from the EU delegation as to  the reasons supporting the decision to apply this 
new requirement only to importe d products, and moreover, only to  imported products from some 
countries.  The US representative also inquired about whether the EU Commission could provide the United States with an update on the status of the measure in the EU Parliament and on whether and 
how it would solicit the input of WTO Members and other stakeholders. 
300. The representative of Mexico
 indicated that his delegation continued to analyse the scope, 
objectives and impact of this EU regulation.  He ad ded that in the opinion of the Mexican delegation, 
some of the provisions contained in this regulati on could affect Mexican exports to the European 
Union.  Thus, his delegation reserved their right to continue to analyse this concern and to express its 
views during future meetings. 
301. The representative of the European Union  replied to these comments by indicating that 
indeed, a 2005 EU Commission proposal for a regula tion on the indication of country of origin for 
certain products was under discussion in the EU Par liament and Council.  She added that the EU 
Parliament had introduced a number of important amendments to the EU Commission’s proposal, in 
particular, a limitation on the scope of application of the draft regul ation to a list of end consumer 
goods, as well as the inclusion of a sunset clause.  She also mentioned that the Council of Ministers 
was examining the EU Parliament’s amendments but that there was no date yet set for the adoption of 
a common position.  She also expressed her delegati on's view that consider ing that it was highly 
possible that the text resulting from the first reading by both institutions would significantly modify the Commission’s original proposal; it was prematur e to enter into a detailed discussion about this 
regulation in the TBT Committee. 
(xxv) United States – California Code of Regula tions:  Chapter 53 Safer Consumer Product 
Alternatives (G/TBT/N/USA/579 and Corr.1) 
302. The representative of the European Union
 indicated that her delegation would appreciate an 
update on the planned revision of Chapter 53 of the California Code of Regulations on the Safer 
Consumer Product Alternatives.  She recalled that  during the previous TBT Committee meeting, the 
United States had notified the planned revision of this Code of Regulati ons on 26 October 2010, but 
had withdrawn the notification some days later.   She mentioned that the European Union had 
discovered that a newly revised text had been submi tted to public consultation in the territory of the 
United States on 16 November 2010.  She added that the period for submitting comments on this 
modification had been 15 days.  Nevertheless, she indicated that this information had never been 
transmitted through the TBT notification procedure.  She clarified that the European Union had not 
learnt of any new developments in this regard  since November 2010, and that her delegation was 
interested in knowing if the proposal was still under discussion.  Moreover, she stated that the 
European Union was also aware that several US St ates were preparing legislation on the control of 
chemicals and chemicals in articles.  Thus, she e xpressed her delegation's desire to get confirmation 
about whether these State legislations, when containing technical regulations or conformity 
assessment procedures, would be notified under th e TBT Agreement, and whether a comment period 
of at least 60 days would be given. 
303. The representative of the United States  replied recalling that during the previous TBT 
Committee meeting, the United States determined, afte r reviewing the measure, that the proposal was 
neither a technical regulation nor a conformity assess ment, and that for this reason they withdrew the G/TBT/M/53 
Page 54  
 
  notification.  He added that th is proposal had gone through a number  of drafts over many years and 
that the public consultation held in November 2010 was simply the latest iterati on in a long process.  
He mentioned that at that moment, several adviso ry panels to the California Department of Toxic 
Substances Control (DTSC) were holding a series of meetings to discuss the appropriateness of revising the draft measure.  He observed that the advi sory panel meetings were open for any interested 
stakeholders to participate.  He reported that, b ased on the outcome of these meetings, the advisory 
panels were going to submit their recommendations  to the DTSC on how the measure could be 
revised.  Finally, he stated that based on these recommendations the DTSC would submit a new version of the measures for public comment.  Ho wever, the US delegation was not aware of any 
specific dates for the submission of the new propos al for public comments.  He announced that the 
United States was going to review the proposed m easure to determine if it constituted a technical 
regulation or a conformity assessment procedure,  in which case the United States would notify it 
under the TBT Agreement if appropriate.  He noted  that the European Union had drawn attention 
toother regulations that might be  under development in other US States, and he announced that the 
United States was going to continue monitoring th ese regulations, and notify them if appropriate as 
well. 
(xxvi)  Turkey – Communiqué SUT 2010 regarding documen tation requirements for medical devices 
304. The representative of the United States
 recalled that during the previous TBT Committee 
meeting the United States had introduced this issue and noted that it had serious concerns regarding 
Turkey's new medical device reimbursement regul ation Communiqué SUT-2010.  The United States' 
essential concern was that medical devices were alread y regulated by Turkey's Ministry of Health.  
However as of June 2010, all pr oducers of medical devices used in specific areas, specifically 
traumatology, orthopaedic arthroplasty and spinal procedures were also required to comply with a 
second regulation administered by Turkey's Social Security Institute (SGK).  He stated that during that session his delegation raised several transparen cy concerns, noting that the measure was never 
notified to the WTO; that there was no chance for stakeholders to comment about it; and that no time 
period for implementation had been established. 
305. He reiterated previous concer ns about the purpose of the new measure for this second 
regulator to require companies to provide additio nal documents, given that Turkey's Ministry of 
Health already regulated these products for safety and efficacy and did not require companies to 
provide these additional documents.  He questione d the necessity of having a second regulator laying 
down technical requirements for medical devices that we re already regulated by Turkey's Ministry of 
Health.  In addition, the United States expressed its desire to know the basis on which the specific 
devices regulated by the SGK measure were se lected.  With respect to the documentation 
requirements themselves, the US representative no ted that producers needed to provide written 
evidence that each group of products was certified by the regulator in the country where the products 
were manufactured or from which th ey were imported, and that they were used in that country.  
According to the United States, this situation w as problematic because sometimes certain devices 
were manufactured in countries where they were not used.  Thus, producers could not obtain the 
required certification in those countries.  Therefore,  producers essentially were forced by the measure 
to ship their products to another country where th e producer could obtain a certificate.  In the United 
States' opinion this seemed to be unnecessary, time consuming and the cause of additional costs.  
Moreover, he recalled that many medical device regulators around the world did not provide 
documentation on product usage or proof of reimburse ment.  Thus, in the United States' view it was 
not clear what purpose this information served.  Th erefore, the representative urged Turkey to notify 
this measure under the TBT Agreement for comments; to  meet with the industry stakeholders to hear 
their concerns; and to take action to eliminat e or modify any of these unnecessary documentation 
requirements so that suppliers could continue to pl ace their products on Turkey's market provided that 
their products satisfied the technical requirements of the Ministry of Health.  G/TBT/M/53 
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  306. The representative of Turkey  explained that in Turkey, medical devices were regulated under 
three individual legislations.  The first was th e regulation on medical devices, the second was the 
regulation on in-vitro medical devices, and the thir d was the regulation on active implanted medical 
devices.  She added that medical devices, either domestically produced or imported, had to comply 
with these technical regulations in order to be marketed in Turkey, and that the CE mark was assumed 
to be the indicator of that compliance. 
307. She also explained that while medical devices w ith the CE mark could be freely marketed in 
Turkey, Turkey's Social Security Institute (S GK) would choose among them those in relation to 
which it would pay reimbursements.  In this selec tion process, the SGK based its decisions primarily 
on public interest considerations, ensuring that  patients were provided high quality products.  
Secondarily, public expenditure and bu dgetary targets are also considered .  She clarified also that the 
SGK was part of Turkey's public social security syst em, and that it covered the health expenditures of 
80% of population, accounting for approximately 56 million people.  Thus, in Turkey's view, the documentation requirements established by the SGK should be assessed from this perspective.  Most 
of the documents requested by the SGK were required by  relevant legislation, in  particular in relation 
to the CE marking.  Other documents were required to indicate the prices paid by the social security 
institutions in the originating co untry, to assist the SGK to estab lish its own price criteria.  The 
representative of Turkey highlighted that these doc ument requirements were applied equally to both 
domestic and imported products.  In  addition, in Turkey's opinion these documents were already 
required by the authorities of the countries where the products originated. She therefore concluded 
that no new documentation requirement or new conf ormity assessment system was created by the 
measure. 
(xxvii)  Italy – Law on "Provisions concerning the marketing of textile, leather and footwear product" 
(G/TBT/N/ITA/16) 
308. The representative of India
 requested an update from the European Union on the current 
status of this labelling law and on whether the va rious comments submitted by India had been taken 
into account when finalizing this law.  He clarifie d that India's specific trade concern regarding this 
law was that it required compliance at each stag e of the production process which went against the 
basic premise of an industry that was based on glob al and multiple sourcing.  In India's view this 
requirement was onerous for exporters, especially from developing countries, and was more trade 
restrictive than necessary to fu lfil the legitimate objectives. 
309. Moreover, India was concerned about the requi rement established by this law to provide 
employment-related information, which in India's opinion, constituted information referring to non-
product related process and production methods wh ich were fields not covered by the TBT 
Agreement.  He added that India believed that this information was clearly unwarranted as it sought to 
interlink labour issues with trade, altering the cond itions of competition to the detriment of imported 
goods.  Thus, in India's view this requirement w as inconsistent with the provisions of GATT.  
Similarly, according to India, the reference to  compliance with regulations on environment was 
another issue of concern and was clearly a trade ba rrier that would affect exports from developing 
countries.  Finally, he asked the delegation of the European Union whether Italy had considered other 
less trade-restrictive regulatory alternatives to fulfil its objectives. 
310. The representative of the European Union  recalled that during the previous TBT Committee 
meetings, her delegation ha d reported that the Italian authorities ha d decided, due to on-going internal 
discussions in the European Union, to postpone the application of this law.  Consequently, the law 
would be effective only after the adoption of the In ter-Ministerial decree pursuant to Article 2 of the 
law in question.  She confirmed that discussions about the implem enting measure were still taking 
place in the European Union, and that this circ umstance made it impossible to provide further G/TBT/M/53 
Page 56  
 
  clarification at this stage.  She announced, however , that once the internal discussions were finished, 
the EU delegation would provide India and th e TBT Committee with further clarification. 
(xxviii)  Indonesia – Decree No:  Kep-99/MUI/III/2009 relating to Halal certification 
311. The representative of the United States
 expressed his delegation's conviction that the United 
States shared Indonesia's goal of ensuring that fo od products labelled halal complied with Indonesia's 
requirements.  However, he indicated his delega tion’s belief that Indonesia's objective could be 
accomplished without disrupting trade.  In his view, avoiding the creation of trade disruptions required additional transparency including ensuring th at suppliers and certifiers were aware of the 
existence of new requirements; allowing them to review and comment on those requirements in draft 
form; taking into account those comments by the relevant authorities; as well as having a reasonable 
time period to comply with new requirements.  He  noted that halal certification related to food 
production processes, not food-safety issues.  The Un ited States also expressed its appreciation for the 
recent visit by Indonesian authorities to the United States, resulting in the approval of US-based halal 
certifiers.  Finally, the representative expressed his delegation's desire for future engagement and 
cooperation on this issue between both governments. 
312. The representative of Indonesia
 expressed his delegation's gra titude to the United States for 
raising these concerns about the Decree of the Ma jelis Ulama Indonesia (MUI) on halal certification.  
He reported that further consider ation would be given by the MUI to this issue, and that his 
government would communicate to the relevant US  authorities any developments regarding their 
concerns on this matter.  Finally, he invited the United States to continue discussing this issue 
bilaterally. 
(xxix)  European Union – Toys 
313. The representative of China  reiterated China's longstanding concerns with the European 
Union's new Toy Safety Directive.  He noted that this directive had entered into force  on 20 July 
2009, and that EU member States had to finish  transposing the Directive into their domestic 
legislation before 20 January 2011.  China recognized  that protecting children health and safety was a 
legitimate goal.  However, China's representativ e expressed his delegation's disappointment about 
some of the requirements established by this new di rective since they were, in China's view, more 
stringent than necessary and inconsistent with existing international standards. 
314. He noted that the international standard ISO 8124-3:2010 on Safety of Toys specified 
maximum acceptable levels and methods of samp ling and extraction prior to analysis for the 
migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and 
selenium from toy materials and from parts of toys.  However, he continued, the EU directive 
significantly expanded the list of regul ated substances to 19 types of me tals, and added restrictions in 
relation 66 kinds of aromatic co mpounds and many other substances classified as carcinogenic, 
mutagenic, and reprotoxic (CMRs) substances.  In China's opinion, overly extensive and unnecessary 
chemical requirements would substantially increase co sts to toy manufacturers, in particular for small 
and medium enterprises (SMEs), leading to unnecessary barriers to trade. 
315. He also expressed China's hope that the EU woul d rectify and adhere to current international 
standards, so to avoid the creation of unnecessary ch emical restrictions.  In this context, China 
suggested eliminating the limits to non-toxic or low toxic metals such as Zinc, Nickel, Manganese, 
Boron and Cobalt, which had already been scientific ally proved to have negligible effect on human 
health.  In addition, China welcomed the principl e set forth in the directive stating that "all 
modifications of the Directive do not impose unnecessary burden and costs on industry, especially on 
small and medium sized enterprises, or administratio ns".  Thus, the representative of China invited the 
EU to take into account the special and differe ntial treatment principle enshrined in the TBT  G/TBT/M/53 
 Page 57 
 
 
  Agreement, and to grant a longer transitional period to developing countries by postponing the 
implementation date of this directive to the year 2015.  He added that further exemption provisions 
were anticipated based on available scientific eviden ce.  Finally, he thanked the EU delegation for the 
informative bilateral discussions both countries had he ld in the past, and welcomed further contact 
between authorities of each side. 
316. The representative of the European Union  indicated that Chinese and European Union 
authorities had a comprehensive regulatory dialogue on toy safety matters, and that the last meeting 
on this issue had taken place in Beijing in November  2010.  He explained that both countries planned 
further seminars and training events in China in th e autumn of 2011, and that in the meantime the EU 
authorities kept regular channels of communication with their Chinese counterparts, in the General 
Administration for Quality Supervision, Inspection and Quarantine (AQSIQ), and in the Chinese local 
inspection and quarantine offices.  He added that  his delegation had been providing the Chinese 
authorities and industry with guidance documents a nd clarification papers on the development and 
implementation of the new Toy Safety Directive.  He announced that the new Toy Safety Directive 
would be applicable as of 20 July 2011, except for the chemical requirements section for which a 
longer transitional period was established, namely, until 20 July 2013. 
317. He also reported that the majority of EU Member States had already published the national 
provisions implementing the new Toy Safety Directive in their respective jurisdictions.  Moreover, he 
explained that one of the main changes to the pre-existing legal framework on toy safety involved 
requirements for the use of chemicals in toys.  Thus , one of the goals of the EU toy safety directive 
was to enhance those requirements for substances that were carci nogenic, mutagenic or toxic for 
reproduction (CMR), and heavy elements in toys lik e lead or other heavy metals and allergenic 
fragrances.  He specified that these requirements ha d been established taking into account the best 
scientific evidence available at that time, and th at the directive foresaw the possibility to amend 
certain chemical requirements in order to ensure the constant alignment of the directive with the latest 
scientific evidence.  He also i ndicated that the EU authorities were open to receiving any additional 
scientific evidence, and that they would carefully examine it with a view to determining whether a 
proposal for amendment was justified.  In order to facilitate the implementation of the new rules, the 
European Commission had prepared a number of guidance documents, and a very comprehensive 
guide was already available.  In addition, more  specific guidelines on the technical documentation for 
the safety assessment procedure, including the ch emical safety assessment, were under development 
and were soon to be finalized.  
318. Moreover, existing standards were also being re vised at that moment and, with the exception 
of new standards related to chemicals, all revised  standards were going to be published before the 
entry into application of the new Toy Safety Dir ective (expected publication date: late spring 2011).  
He also stated that work on new standards on ch emicals was well underway and the publication of the 
new standards was expected before July 2013.  He noted that, in conducting these activities, EU 
standardization bodies worked in close coordination w ith the relevant technical committee in ISO, and 
their counterparts in other major trading partners, including China and the United States.  He reported 
that experts from China's Standardisation Administ ration (SAC) had been invited to participate as 
observers in the work of relevant CEN techni cal committees, and that there was also regular 
coordination with the American Society for Testin g and Materials (ASTM).  In his opinion, this 
coordination effort would hopefully contribute to a gr eater global alignment of standards in the field 
of toy safety. G/TBT/M/53 
Page 58  
 
  3. Follow-up on concerns raised 
319. The representative of Mexico
 drew the Committee's attention to the document 
G/TBT/GEN/111 which had been tabled in response to concerns raised by a number of delegations.  
The submission contained information on a decree  published by the Mexica n Government amending 
the Regulation on Sanitary Control of Products and Services.  The representative of Mexico explained 
that this decree, which had entered into fo rce on 27 January 2011, meant that it was no longer 
necessary to provide a Spanish translation of the in ternational nomenclature of cosmetic ingredients 
for the labelling of perfumery and beauty products .  This, he said, would hopefully ease the concerns 
expressed by Members and would also fac ilitate trade in the products concerned. 
C. EXCHANGE OF EXPERIENCES   
1. Good Regulatory Practice 
320. The Chairman  summarized discussions in the area of good regulatory practice held since the 
end of 2010, including discussion at informal mee tings in September 2010 and February 2011.  He 
drew the Committee's attention to the following points: 
(a) Compilation of existing work :  Sub-paragraph 11(a) of the Fifth Triennial Review 
had given the Committee the task of compiling a list of guidelines for Good 
Regulatory Practice taking into account Members’ experiences and existing relevant work of other organizations.  In this re gard, Members had emphasized the need to 
consider both work that had already been done and work that was on-going.  Work by 
APEC and the OECD has been mentioned by several Members.  Delegations had also asked the Secretariat to start compiling this  information so that the Committee could 
use it as a starting point for the debate. 
(b) Mechanism for implementing good regulatory practice :  Sub-paragraph 11(b) 
gave the Committee the task of preparing an illustrative list of mechanisms for the 
actual implementation of Good Regulatory Prac tice.  This list was to be based on 
contributions from Members.  The end objective, thus, was the development of an 
agreed list of "best practices".  The Chairman  noted in this regard that some Members 
were of the view that more information exchange was needed before developing an 
agreed list of "best practices".   
(c) Internal coordination :  In line with sub-paragraph 11(c), the Committee was to 
continue to share views and experiences on aspects of regulatory coordination and administrative mechanisms to facilitate internal coordination between competent 
authorities, including between trade policy an d regulatory authorities, and interested 
parties.  In this regard, it had been su ggested that the Committee could consider 
developing a simple questionnaire about mech anisms that had pe rhaps already been 
developed and that were being used to impl ement national coordination.  It was also 
noted that information in the questionnaire  could be complemented by more detailed 
information contained in submissions. 
321. The representative of the United States
 said that there had been many developments in the 
United States on good regulatory practice since the last meeting of the TBT Committee (November 2010).  To begin with, he drew de legations' attention to the Report from the APEC Sub-Committee on 
Standards and Conformance Sixth Conference on Good Regulatory Practices – a meeting held in 
Washington in March 2011.  That conference had b een led by the United States and co-sponsored by 
Chile, Japan, Malaysia, New Zealand, Peru and Sing apore.  It had brought together experts from 
government, business and international organisations  to discuss critical regulatory issues facing the  G/TBT/M/53 
 Page 59 
 
 
  APEC community.  It specifically focused on the n eed to achieve efficient and effective regulatory 
outcomes while promoting a regulatory environment that was conducive to trade, investment and job creation in the region.  Speakers over the two-day conference almost unanimously stressed the importance of greater transparency and public par ticipation in promoting better regulatory outcomes 
while avoiding unnecessary barriers to trade.  Indeed , several participants, including those from the 
business community, conveyed a sense of urgency ab out the need for greater transparency and 
alignment of regulatory approaches in the region.  Representatives from APEC member economies, and from bodies such as the WTO, ISO, IEC, the Wo rld Bank, ASTM International, IEEE, and ILAC 
had contributed to the conference.   
322. The US representative summarized some of the key points delivered by Mr. Cass Sunstein
11, 
of the US Office of Information and Regulatory Affairs (OIRA), the lead agency over the US 
regulatory process, at the Conference.  In his remarks12 Mr. Sunstein discussed a new Executive Order 
issued by US President Obama (Executive Order 1356313) that dealt with good regulatory practice 
issues in all areas (not only TBT).14  The Executive Order emphasized general principles that were 
important for regulation, including the need to use th e best available science, public participation, use 
of the least-burdensome tools, considering costs and benefits and measuri ng and seeking to improve 
actual results.  On transparency for instance, th e Order required US Federal Agencies to use the 
internet to promote an open exchange; agencies were generally asked to provide a period of 60 days to 
enable public comment and provide timely online access to the relevant scientific and technical 
findings to allow them to be scrutinised.  Also, th e new Order directed Federal Agencies to take steps 
to harmonize, simplify and coordina te regulations – and to avoid re dundancies, inconsistencies and/or 
overlapping requirements.  The representative of the United States stressed the importance of 
coordination both within agencies and across agencies .   The Order also explicitly connected the goal 
of harmonization with innovation: it directed agenci es to achieve their regulatory goals in ways that 
promoted innovation.  Agencies were directed to identify and consider flexible approaches that 
maintained freedom of choice for th e public.  On the topic of science,  the representative of the United 
States noted that the Order stressed that scientific  integrity was extremely important as a basis for 
regulation and directed each agency in the Federal Government in the United States to ensure the 
objectivity of the information on which it relied to support its regulatory actions.  Finally, the Order 
also called for a retrospective analysis of existi ng regulations and it directed agencies to produce a 
preliminary plan to review significant regulations. 
323. The representative of the United States reporte d that in addition to discussing regulatory 
capacity issues, Mr. Sunstein had also addressed regula tory alignment issues.  It was noted that this 
issue was sometimes more difficu lt because different economies had di fferent situations and needs 
and it was legitimate to strike different bala nces.  However, diverse approaches sometimes 
compromised trade and growth in a way that was unhelpful for economic goals.  Hence, the United 
States was going to increase its work in the area of regulatory cooperation.  In particular, the United 
States was considering efforts to promote alignment including with Mexico, Ca nada and Europe – and 
there were now new "regulatory co-operation coun cils" with Canada, Mexico and the European 
Union.  The representative of the United States hoped to  be able to reflect some of this work in the 
TBT Committee's upcoming Sixth Triennial Review. 
324. The representative of the United States al so drew the Committee's attention to a 
Memorandum dated 11 March 2011 for the Heads of US Federal Agencies.  The Memorandum, from 
                                                      
11 Cass R. Sunstein, Administrator, U.S. Office of Information and Regulatory Affairs (OIRA), Office 
of Management and Budget (OMB). 
12 http://www.whitehouse.gov/omb/o ira_irc_international#APEC . 
13 "http://www.whitehouse.gov/the-press-office/201 1/01/18/improving-regulation-and-regulatory-
review-executive-order" . 
14 http://www.whitehouse.gov/the-press-office/2011/01/ 18/fact-sheet-presidents-regulatory-strategy . G/TBT/M/53 
Page 60  
 
  three agencies in the White Hou se (the Office of Science and Technology Policy, the Office of 
Information on Regulatory Affairs and the USTR ), concerned “Principles for Regulation and 
Oversight of Emerging Technology.”  A new Wh ite House-led Taskforce on Emerging Technology 
Inter-Agency Policy Coordination w ould endeavour to create guiding coherent US Government policy 
on regulating emerging technologies so that the United States would become better coordinated and 
better able to engage internationa lly.  Indeed, the representative of  the United States noted that many 
of the principles in the Memorandum, whether about sci entific integrity, public participation, benefits 
and costs, and risk management, were the same pr inciples that were applicable to good regulatory 
practice in general.  One of the elements in the Memorandum was the importance of international 
cooperation, including the need for US regulators to send their officials to participate in the 
development of international standards so as to try to achieve harmonization and to try to work with 
other governments to coordinate as far in advance as possible on potential international approaches to 
regulation in new technologies.  These efforts woul d promote greater alignment thereby, perhaps, 
preventing the creation of new specific trade concerns.   
325. The representative of Mexico
 said that his delegation was currently preparing a contribution 
to the Sixth Triennial Review.  In the past, Mexi co had presented its experiences in the area of good 
regulatory practice, including with respect to on metrology and standardization.   With respect to regulatory cooperation, his authorities were involve d in an important process of defining activities 
together with the United States and Canada.  Thes e experiences would be shared in the Committee's 
workshop to be held in November 2011.  The repre sentative of Mexico stressed that his delegation 
was also considering efforts in SPS area – regulator y cooperation was not limited to TBT matters.  In 
addition, Mexico was considering broadening its  cooperation in the APEC, Pacific and Latin 
American context as well as in the context of FTAs with Central American countries. 
326. The representative of the European Union
 noted that his delegation was also preparing a 
contribution on good regulatory practice for the Co mmittee's Sixth Triennial Review.  In terms of 
policy developments, the most important documen t was a recent communication on Smart Regulation 
in the European Union15, dated 8 October 2010.  This document built on the experience of the EU 
Better Regulation Policy to propose further improveme nts and enhancements.  The EU representative 
said that the most distinctive feature in this Communication was the emphasis placed on considering 
the whole regulatory policy cycle, as well as the n eed to evaluate existing legislation and assess the 
benefits and costs of legislation as actually applied.  Hence, the Eu ropean Commission had launched a 
so-called "fitness check" to verify whether existi ng regulations were actually serving their intended 
purposes, and, if not, whether amendments needed to  be proposed.  This fitn ess check was in addition 
to existing EU policies already discussed in the Committee under the topic of good regulatory practices, namely the initiatives in the field of simplification of legislation and reduction of 
administrative burdens.  Another important new aspe ct was the reinforcement of cooperation between 
the European Commission (as the institution in the European Union which initiated legislation) and 
the other actors in the EU regulatory landscape, in cluding notably the European Parliament and the 
Council as co-legislators and the Member States as responsible for implementa tion and enforcement.  
A third aspect was to improve internal standards for stake-holders consultation to allow for an 
extended consultation period (prolonging it from  the current 8 weeks to 12 weeks from 2012 
onwards).  This was intended to increase the opportuni ty for interested parties to provide comments.  
The European Union had realized that especially for small and medium sized enterprises (SMEs) it 
took time to prepare positions in the public co nsultation process;  hopef ully prolonging the 
consultation period would maximize the chances to get input from the SME sector. 
                                                     
 
15 http://ec.europa.eu/governance/better_regulation/index_en.htm .  G/TBT/M/53 
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  1. The Workshop on Regulatory Cooperation between Members 
327. The Chairman  drew the Committee's attention to the revised draft programme for the 
Committee's Workshop on Regulatory Cooperation between Members (JOB/TBT/7/Rev.1).  The 
programme had been revised to take into accoun t comments made at the last meeting of the 
Committee as well as at the subsequent informal  meeting.  He recalled that Members had put 
particular emphasis on the importance of developing  country contributions.  He said that workshop 
was scheduled to be held on 8-9 November 2011,  back-to-back with the regular TBT Committee 
meeting (on 10-11 November). 
328. The representative of Mexico  expressed his delegation's interest  in participating in the panel 
on "lessons learned" (in draft programme).  He suggested that the programme explicitly identify 
various types of regulatory cooperation and said that it would be important for at least one 
presentation to illustrate the topic of harmonizati on, compatibility and equivalency.  Also, in 
Mexico's, view mutual recognition was one possible approach to regulatory cooperation – even 
though it was related to conformity assessment – and th is topic needed, therefore, also to be discussed 
at the workshop.  
329. The representative of El Salvador  expressed his delegation's appreciation for the transparent 
way in which the Chairman and Secretariat had developed the programme taking into account all 
delegations views, in particular t hose of developing countries.    
2. Standards 
330. On the issue of standards, the Chairman  recalled that during the Fifth Triennial Review, the 
Committee had considered, in depth, the issue of st andards.  In particular, the Committee had looked 
at the issue of the development of and use of sta ndards.  In this regard, the Committee had recognized 
the need for international standards to be relevant , and that they effectively respond to regulatory and 
market needs, as well as scientific and technol ogical developments, while not creating unnecessary 
obstacles to international trade.  Among other th ings, the Committee had recommended the circulation 
of case studies – or other research – on the impa cts of standards on economic development and 
international trade.  He also recalled that Members had been invited to share their experiences related 
to the implementation of the TBT Agreement, including the Code of Good Practice, and the 
Committee had stressed the importance of participa tion in the work of international standardizing 
bodies.  In respect of the latter, the Chairman re called that the Committee ha d encouraged Members, 
Observer organizations and relevant  bodies involved in the development of standards, to exchange 
information on initiatives implemented, su ccesses achieved and obstacles encountered.16 
3. Conformity Assessment 
331. The Chairman  recalled that at the Fifth Triennial Review, the Committee had agreed to 
continue the sharing of experiences with a view to furthering the understanding and implementation 
of Articles 5-9 of the TBT Agreement.  He noted th at the relevant recommendations were contained in 
paragraph 19 of G/TBT/26.  In previous discussions on this issues, informally and formally, a number 
of points have been raised that, he noted, we re worth recalling (in no particular order):   
(a) Criteria :  It had been pointed out that the Committee needed to start considering 
"criteria, methods of analysis and con cepts" used by Members to inform their 
evaluation of the range of choices in confor mity assessment procedures.  This, it had 
been suggested, could be done in the process of information exchange. 
                                                      
16 G/TBT/26, paras. 25-27(a). G/TBT/M/53 
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  (b) Incremental approach :  Several delegations had not ed that this information 
exchange on conformity assessment needed to precede the development of guidelines.  At the informal meeting held in February , the importance an incremental approach 
(one "bite ‐size piece" at a time) had been emphasized by several delegations. The 
Chairman noted that, indeed, in his view, a step-by-step approach was essential to 
triennial review recommendations of this nature which entailed much work by the 
Committee and that perhaps would take a longer period of time to complete; in other 
words, better to start small and build on this – even if the time horizon extended 
across reviews.   
(c) Flexibility :  any guides developed under 19(c) needs to be flexible and non-
mandatory. 
332. The representative of New Zealand
 noted that progress needed to be made on 
recommendations from the Fifth Triennial Review.  Sh e drew the Committee's attention to one of the 
sessions at the APEC Conference on Good Regulatory Practice (mentioned in the US statement, above) that had considered the importance of regulatory cooperation in removing unnecessary 
obstacles to trade and reducing the transaction cost s for businesses.  She noted that several case 
studies had been presented that underscored the m essage that regulatory cooperation was not a matter 
of "one size fits all".  Much depended on the speci fics of the trade and the main objectives that were 
being sought.  The TBT Committee needed, hence, to develop guidance for the choice and design of 
trade facilitation mechanisms.   
333. The representative of New Zealand wished to highl ight three presentations in particular from 
the above-mentioned APEC Conference that, in he r view, were directly relevant to the TBT 
Committee's work.  One presentation, from Mexico's Ministry of Economy, set out the Mexican 
government's efforts to improve regulations through  determining equivalence with US and Canadian 
technical regulations and conformity assessment pr ocedures for a range of electronic products.  In 
New Zealand's view this could be a good case of a unilateral option for facilitating trade.  Another 
presenter, from Singapore, had outlined the ASEAN e xperience with developing an integrated market 
through harmonization of standards,  technical regulations and conf ormity assessment procedures and 
framework MRAs.  Third, a representative fro m Industry Canada had presented on the APEC 
Telecoms MRA which had begun simply as a fram ework for mutual recognition of conformity 
assessment results, but that was currently being fu rther developed into an MRA on equivalence of 
technical regulations.  This could provide an in teresting case study for identifying the conditions that 
had to exist in order to support a more sophisticated  model of integration.  Each of these presentations 
had provided rich practical experience.  New Zeal and encouraged Mexico, Singapore and Canada to 
develop these APEC presentations into case studies on their experiences for the TBT Committee.   
334. The representative of Mexico
 reiterated that, in his view, it was not practical to separate 
regulatory cooperation and conformity assessment.  In the Mexican experience regulatory cooperation 
was not only related to technical re gulations but also to conformity assessment.  While it was logical 
not to speak about certification, accreditation, labor atory tests in this context – nonetheless, the 
mechanism for conformity assessment were rela ted to cooperation activities between Members.  
335. The representative of Singapore  said that his delegation w ould consider developing a 
presentation as suggested by New Zealand and re vert to the Committee on the matter.   G/TBT/M/53 
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  336. The representative of the European Union  suggested that the Co mmittee could consider 
inviting representatives from organisations that could offer interesting contributions to the 
Committee's discussion on conformity assessment.  Noting the widespread in terest in accreditation as 
one of the mechanisms that was contained in the Committee's illustrative list of mechanisms to 
facilitate acceptance of conformity assessment resu lts, he suggested that the Committee consider 
inviting representatives of the ILAC and IAF to gi ve a presentation on how international cooperation 
in the accreditation field had developed and provide  information about multilateral arrangements that 
existed within IAF and ILAC to facilitate the r ecognition of accreditation certificates.  There were 
other examples of organizations which had de veloped mechanisms for voluntary co-operation 
between conformity assessment bodies and which had facilitated the recognition of test reports and 
core certificates, based on a voluntary cooperation between the participating conformity assessment 
bodies, e.g. the IEC CB Scheme for Electrical Safety and the IECEx Scheme for equipment in explosive atmospheres.  The Committee could al so consider inviting representatives from these 
organizations at future meetings. 
337. The representatives of Canada
, Thailand  and the United States  supported the EU proposal and 
the Committee agreed  to invite the ILAC and IAF to present relevant work.17  
4. Transparency 
338. The Chairman  recalled the Fifth Triennial Review recommendations on transparency.18  He 
invited the Secretariat to update the Committee on recent developments in the SPS area of relevance 
to TBT.   
339. The representative of the Secretariat  updated the Committee on the new SPS on-line 
notification system, referred to as the SPS Notification Submission System (hereafter, "SPS NSS") 
which had recently gone live on the internet.  This  had first been developed in the SPS area and the 
feasibility of developing in the TBT area was be ing considered.  Essentially, the SPS NSS enabled 
Members to fill out and submit notifications online.  The system was being phased in gradually and, it 
was noted, even when fully developed, Members would still be able to use the old formats of email, 
fax and simple mail to submit notifications.  The on-line submission system itself was designed to 
prompt Members in such a way that the filling in of notifications would become more complete and 
accurate, for instance through the use of drop-down and multiple-choice menus.  There was thus a built-in check in the system whereby a notificatio n could not be submitted unless all the steps had 
been completed.  In practice, the system would allo w several entities (with log-in names) to fill in the 
notifications on-line but only one login-in name pe r Member with administrative rights to actually 
submit the notification to the WTO.   
340. The representative of the European Union
 said that her delegation was keen on seeing this 
project operationalized in the TBT area.  It was im portant to reduce the time which it took between 
sending the notification to the Secretariat and the time when the notification was actually circulated; 
the European Union hoped that also the TBT area c ould benefit from this system as well.  She also 
expressed that her delegation was in favour of developing the WTO TBT Information Management 
System further for the benefit of all Members, name ly by giving a better overview of all information 
related to one notification. For instance, the Eu ropean Union communicated a lot of information 
through addenda and revisions to the original notifi cation to indicate relevant information, including 
the adoption of the final text and the existence of tran slation.  In order to make this information easily 
accessible, it would be helpful if that was linked to the relevant notification and noticeable on the 
                                                      
17 It is recalled that a joint ILAC / IAF presentation was made in the context of a WTO TBT Workshop 
on the Different Approaches to Conformity Assessm ent, including on the Acceptance of Conformity 
Assessment Results (16-17 March 2006, G/TBT/M/38/Add.1, pp. 29-30). 
18 G/TBT/16, pages 8 – 14 (Section D). G/TBT/M/53 
Page 64  
 
  same page, as it was the case on the EU's TBT database.
19  The representative of the EU concluded 
that she would be very interested in other sp ecific ideas to improve the WTO TBT Information 
Management System as a lot of Members had indicated  a strong interest in the further development of 
the WTO TBT Information Management System during the Fifth Triennial Review. 
341. The representative of the United States  drew delegations' attention to a website 
(Reginfo.gov20) that set out information on regulatory actions  that were currently being reviewed by 
the Office of Information and Regulatory Affairs in  the United States.  This website provided an up-
to-date and easy to read graphical representation of regulatory actions currently under review.  It 
showed how many regulations were  being reviewed and by which US  Agency; this data could be 
sorted by what stage the regulation was in the pro cess (i.e., proposed stage, final stage, pre-regulatory 
stage).  It also contained information on the US "unified agenda" where all agencies outlined their 
regulatory priorities for the coming year and laid out what regulations they might be developing in the 
future.  This provided more information than what was required in the TBT Agreement.   
342. The representative of the United States also noted that OIRA had recently developed a new 
mechanism called the international impacts flag.  This  flag was used to identify regulations that were 
under review by the OIRA and that were expected to have international trade and investment effects.  
This applied to all measures being developed at the central level of  government in the United States, 
not only to TBT measures.  A search for possible TBT related measures that US regulators would be 
considering over the next year or so yielded about  15 to 20 different measures (at the pre-rule or pre-
regulation stage, i.e., not notified yet because there was no proposal).  This could be an interesting 
exercise for other Members to consider in the spirit  of Article 2.9.1 of the TBT Agreement, on "early 
notice".  Alternatively, Members could simply c onsider developing a mechanism whereby regulatory 
agencies were contacted and asked for their regul atory plan over the coming year; indeed, most 
agencies probably had such a plan internally.   
343. For example, if a number of Members were planning to regulate emerging areas such as 
nanotechnology, early notice could be helpful in potentially eliminating unnecessary divergences, 
and, over time shrinking the number of specific trade c oncerns raised in the Co mmittee.  Currently the 
Committee spent up to 90 per cent of its time disc ussing specific trade concerns and maybe only 10 
per cent on systemic issues that could prevent such concerns from being raised in the first place.  The 
representative of the United States stressed the im portance of early notice: the earlier Members knew 
about potential regulation the easier it would be to work together and prevent unnecessary 
divergences or other trade problems from emerging.  This was one potential way the Committee could 
really add value to the process through transparency.  This was also relevant to standards: it was 
important for our regulators to be following and pa rticipating  in intern ational standardization 
activities in their particular regulatory areas to pus h for harmonization, where possible.  The United 
States would further develop its thoughts in this ar ea for the Sixth Triennial Review and invited other 
delegations to join them in working on a proposal. 
344. The representative of Mexico  noted that "early notice" was referred to in the Committee' Fifth 
Triennial Review.21  Indeed, Mexico regularly presented pa pers on the Committee where it informed 
about its National Standardization Programme, cont aining all technical regulations and that the 
Federal Government of Mexico and the Standard ization Office would be carrying out over the 
following year.   
                                                      
19 http://ec.europa.eu/enterprise/tbt/ . 
20 http://www.reginfo.gov/publ ic/jsp/Utilities/aboutUs.jsp . 
21 G/TBT/26, para 30 (Footnote 23).  G/TBT/M/53 
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  345. The representative of Canada  was interested in hearing mo re information on how the United 
States had developed the "international flag"; this in formation could be useful for the Membership as 
a whole.   
D. OTHER MATTERS  
1. NTB-related NAMA negotiations 
346. The representative of Canada  drew delegations' attention to  the on-going negotiations on NTB 
matters in the context of the non-agricultural ma rket access (NAMA) negotiations.  He recommended 
that delegations from the TBT Committee follow the subject-matter of these discussions.  There was, 
he said, opportunity for links between the Comm ittee's work on the implementation of the TBT 
Agreement, including with respect to the triennial  reviews, and the on-going negotiations.  The work 
of the Committee could usefully inform these nego tiations as some of the discussions (whether in 
"small groups" or open meetings) were directly relevant to the implementation of the TBT 
Agreement.   
347. The Chairman  encouraged Members and their delegates participating in the NAMA and TBT 
discussion to talk to each other and to share notes  so that value could be added in both the TBT 
Committee and in the NAMA Group.   
III. SIXTEENTH ANNUAL REVIEW OF TH E IMPLEMENTATION AND OPERATION 
OF THE TBT COMMITTEE AGREEMENT UNDER ARTICLE 15.3 
A. ANNUAL REVIEW  
348. The Committee adopted  the Sixteenth Annual Review of the Implementation and Operation 
of the TBT Agreement, as contained in document G/TBT/29 and Corr.1.  
B. THE CODE OF GOOD PRACTICE  
349. The Chairman  drew the Committee's attention to two lists prepared by the Secretariat to 
facilitate consideration of matters  relating to the operation of the Code of Good Practice for the 
Preparation, Adoption and Application of Standards in  Annex 3 of the TBT Agreement.  The first list, 
contained in document G/TBT/CS/1/Add.15, compiles the standardizing bodies that have accepted the 
Code in the period under review.  It was noted th at during the reported period, four standardizing 
bodies from four Members had accepted the Code of Good Practice.  The second list, contained in 
document G/TBT/CS/2/Rev.17 compiles all the sta ndardizing bodies that have accepted the Code 
since 1 January 1995.  Since 1 January 1995, 162 standardizing bodies from 122 Members have accepted the Code of Good Practice.  In addition, the Chairman noted that the ISO/IEC Information 
Centre had prepared the Sixteenth Edition of the WTO TBT Standards Code Directory, which 
contains information received according to paragra phs C and J of the Code of Good Practice for the 
Preparation, Adoption and Application of St andards in Annex 3 of the Agreement.   
350. The Committee took note
 of these documents. 
IV. TECHNICAL COOPERATION ACTIVITIES   
351. The representative of Codex updated the Committee on regional workshops that had been 
undertaken by FAO and WHO with the support of the Codex Trust Fund.22   
                                                      
22 G/TBT/GEN/113. G/TBT/M/53 
Page 66  
 
  352. The Chairman
 drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities (G/TBT/GEN/114). 
V. UPDATING BY OBSERVERS 
353. The representative of the WHO Framework Convention on Tobacco Control  (FCTC), as an 
Observer under the auspices of the World Health Or ganization, informed the Committee on the fourth 
meeting of the Conference of the Parties which had taken place in Punta del Este, Uruguay from 15-
20 November 2010.  During this session, COP4 was gr anted a mandate to conti nue negotiations of the 
draft protocol to eliminate illicit trade in tobacco pr oducts.  In addition, the Conference of the Parties 
established a new working group on price and tax po licies (Article 6 of the FCTC), a new expert 
group on cross-border advertising, promotion and sponsorship (Artic le 13 of the FCTC) and a number 
of decisions on implementation, assistance and reporti ng.  The Punta del Este declaration regarding 
public health policy, international trade and activ ities of the tobacco industry was adopted whereby 
the Convention Secretariat was requested to cooper ate with the WTO Secretariat with the aim of 
sharing information on trade related tobacco control issues.   
354. The representative explained that pursuant to Ar ticle 7 of the Convention, the COP had an 
obligation to propose guidelines for the implementation of certain articles of the Convention.  During 
COP4, the content of the Partial Guidelines on the Regulation of the Contents of Tobacco Products 
and the Regulation of Tobacco Products Disclosures (Articles 9 and 10 of the FCTC), was adopted by 
consensus.  The Representative explained that "partia l" in the title referred to the actual Guidelines 
and not to whether they were adopted or not.  Th is reflected the "step by step" procedure for the 
Guidelines for Articles 9 and 10 which had been ap proved at previous sessions of the COP, whereby 
the guidelines would be adopted in various stag es based on whether they had been completed.23  
Further progress, she said, would also depend on the validation of chemical methods for testing and 
measuring cigarette contents  and emissions.  With respect to Articles 9 and 10, the Parties were of the 
view that there was sufficient country experience,  as well as scientific and medical evidence to 
proceed with their adoption.  The Representativ e invited the Committee to Members to review 
outstanding topics which were available on the website. 24 
355. The representative of the UNECE  updated the Committee on the Working Party on 
Regulatory Co-operation and Standardization Policies.  She informed the Committee that the Group of Experts on Risk Management in Regulatory Sy stems had begun its work.  This group, she said, was 
currently developing a framework of best practices and would ultimately pro duce material for training 
and capacity building.  The representative also  updated the Committee on the development of 
common regulatory frameworks in sectors of particular  interest to Member states. One of these, she 
said, was the publication of a guide for governme nts on the regulation of equipment used in 
environments with an explosive atmosphere (IECEx scheme
25).  Lastly, the representative informed 
the Committee that the Working Party would hold a planning meeting in Stockholm where it would look at ways to reinforce its co-operation with  the IECEx scheme so as to provide training and 
awareness events for regulators on the recently  published common regulatory framework.  
356. The representative of ISO
 informed the Committee that ISO had begun implementing its new 
action plan for developing countries.26 ISO, he said, would present a document on all the packages 
available to ISO Members on capacity building, part icipation in ISO technical work, awareness and 
                                                      
23 Articles 9 and 10 and relevant explanations are available on  
http://www.who.int/fctc/guidelin es/article_9and10/en/index.html . 
24 All COP decisions are available on http://www.who.int/fctc . 
25 http://www.iecex.com/ . 
26 http://www.iso.org/iso/iso_action_pla n_developingcountries-2011-2015.pdf .  G/TBT/M/53 
 Page 67 
 
 
  institutional strengthening at the level of national standards bodies at the next meeting of the TBT 
Committee. 
357. The representatives of the ITC , the IEC  and Codex  updated the Committee on their on-going 
activities in developing countries and on-going work related to TBT.27 
VI. ELECTION OF CHAIRPERSON 
358. Pursuant to Article 13.1 of the TBT Agreem ent, the Committee elected Ms Denise PEREIRA 
(Singapore) as the Chairperson of the TBT Committee. 
VII. DATE OF THE NEXT MEETING  
359. The next regular meeting of the TBT Committee will take place on 15-16 June 2011 . 
 
__________  
 
                                                      
27 G/TBT/GEN/115;  G/TBT/GE N/112;  G/TBT/GEN/113.