WORLD TRADE  
ORGANIZATION  TN/MA/W/140 
28 October 2010 
 (10-5647) 
Negotiating Group on Market Access Original:   English 
   
 
MARKET ACCESS FOR NON-AGRICULTURAL PRODUCTS 
 
Answers by the European Union to questions ra ised by various WTO delegations regarding the 
proposed Understanding on Non-Tariff Barriers Pe rtaining to Standards, Technical Regulations  
and Conformity Assessment Procedures fo r Chemical Products (TN/MA/W/137/Rev.1)  
 
Communication from the European Union 
 
  The following communication, dated 15 October 2010, is being circulated at the request of 
the delegation of the European Union. 
_______________ 
 
 
I. GENERAL 
1. What are the differences between the EU proposal and that of Argentina and Brazil? 
(Question by the African Group)  
 
- Both proposals strive to develop disciplines th at would facilitate trade of chemical products 
whilst ensuring that regulatory measures for achieving legitimate public policy objectives can 
be taken as deemed necessary by members. Th e EU proposal is based on the original 
Argentina concept paper which has ensured that  conceptual differences are minor. There are 
differences in the distribution of importance give n to various aspects and in the expression of 
these concepts. Co-sponsors of both proposals are therefore continuing discussion with a view to coming to common solutions. The latest revisions of both proposals have started to converge on a number of aspects. 
 
2. Do the proponents intend this understanding to  be a covered Agreement in terms of the WTO 
Dispute Settlement Understanding (DSU)? (Question by the African Group)  - Yes, this understanding shall be part of the single undertaking and shall be covered by the 
Dispute Settlement Understanding (DSU). 
 
II. SCOPE AND COVERAGE 
3. Can the EU explain their intended product  coverage? (Question by the African Group) 
 
- The new proposed text of the Understanding (June 2010) states that the Understanding shall 
apply with respect to chemicals in HS chapters (28-39).  However, this is an issue requiring 
the agreement of members and therefor e further discussion will be necessary. 
 TN/MA/W/140 
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  4. Concerning scope and coverage, what is the definition of "chemicals" in paragraph 1.1.? 
(Question by Argentina and Brazil) 
 
- Chemicals are aptly defined under "15. Definiti ons" and include all produc ts considered under 
the Strategic Approach to International Chem icals Management (SAICM), i.e. chemicals, 
including in articles, except to the extent th at the health and environmental aspects of the 
safety of the chemicals and articles are regul ated by a domestic food or pharmaceutical 
authority or arrangement. 
 5. The EU proposal is said to apply to "chemi cals".  How does the EU propose to define 
chemicals?  By harmonized system tariff chapter? (Question by Canada) 
 6. Please explain the relationship between the defi nition of "chemicals" in Article 15 and the 
proposal in Article 1.1 to define "chemicals" by re ference to HS Chapters. (Question by  the Kingdom 
of Saudi Arabia) 
 
- The HS was designed to be a framework for use as a multipurpose nomenclature.  The 
headings are grouped in chapters with the fo cus on classes/groups of chemicals. While this 
has proved useful for certain purposes, it has fro m a chemicals definition perspective certain 
limitations for regulatory purposes.  The con cepts of chemicals in the HS (originally 
developed for tariff purposes) and in technical  regulations (as being discussed in the NTB 
negotiations) are different and not interchangeab le.  For the purposes of this understanding, a 
clear and comprehensive definition is require d combining a practical regulatory definition 
with the HS nomenclature. 
 7. Is petroleum included in the product co verage? (Question by the African Group) 
 
- As petroleum products are covered by HS ch apter 27, petroleum could be included in the 
product coverage if members have a d esire to enlarge the coverage beyond 
HS chapters 28 39. The European Union has however no intention to widen the coverage. 
 8. The proposed Understanding would apply "with r espect to chemicals in HS Chapters [28-39]" 
and Members would assume obligations with resp ect to "standards, technical regulations and 
conformity assessment procedures."  However, Article  1.3 of the TBT Agreement provides that "[a]ll 
products, including industrial…products, shall be s ubject to the provisions of this Agreement."  
Moreover, the TBT Agreement imposes  obligations with respect to standards, technical regulations 
and conformity assessment procedures.  Could the EU please clarify the relationship between the 
proposed new obligations of the Understanding an d the existing obligations of WTO Members under 
the TBT Agreement? (Question by the Kingdom of Saudi Arabia) 
 
- The EU proposal builds upon the horizontal ru les laid down in the Agreement on Technical 
Barriers to Trade. However it includes specific pr ovisions which are of particular relevance to 
the labelling and classification of chemicals, as we ll as the management of chemicals, such as 
obligations to collect and register data, to pe rform testing on chemicals, or to accept existing 
data from other WTO Members. The Understa nding establishes more detailed rules for the 
testing and assessment of chemicals, thereby re ducing further unnecessary barriers to trade. 
  TN/MA/W/140 
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  9. Is the Understanding meant to cover chemicals in products/articles or chemical products only, 
which are different? (Question by Canada)  - The Understanding should cover chemicals on their own and in mixtures.  In certain 
circumstances chemicals in articles will also be covered, except to the extent that the health 
and environmental aspects of the safety of the chemicals and articles are regulated by a 
domestic food or pharmaceutical  authority or arrangement. 
 10. Are pesticides, explosives, food additives, etc.  to be covered by th e understanding? Polymers 
and monomers? Intermediat es? (Question by Canada) 
 
- See reply to Question 4.   
 11. Is this understanding inte nded to cover nanotech substa nces or biotechnology as well? 
(Question by Canada) 
 
- Yes, but for biotechnology, only biotech substa nces originating from biotechnology, in other 
words, substances using biotechnology fo r their manufacture will be covered. 
 12. With respect to paragraph 1 (scope and coverage) does this understanding allow for the 
exclusion of certain chemicals from some of its pr ovisions such as the registration of data based on 
the level of the risk that the product poses? (Question by the African Group) 
 
- This possibility remains open and requires further discussion. 
 
III. INTERNATIONAL STANDARDIZATION AND REGULATORY 
HARMONIZATION 
13. Article 2.1 provides a list of "the main relevant international standard-setting bodies", 
including the OECD, for the purposes of applying  certain provisions of the TBT Agreement.  
However, the OECD has only very limited member ship, and is not reflective of the broader WTO 
Membership.  In light of this, could the EU explain why it wishes to reference the OECD as a standard-setting body for WTO purposes? (Question by  the Kingdom of Saudi Arabia)  
14. How would the characterization of the OECD  as "International Standard-Setting Body" be 
justified according to the definition of "International Body or System" presented in Annex I of the TBT? Is the OECD open to the relevant bodies of  at least all members of WTO? (Question by 
Argentina and Brazil) 
 
15. Malaysia notes that the proponent has liste d a few bodies which are considered relevant 
standard-setting bodies for the purpose of this Unde rstanding which includes testing, data acceptance 
and good laboratory practice of the Organisati on for Economic Cooperation and Development 
(OECD) and classification and labelling of chem icals under the United Nations Sub-Committee of 
Experts on Globally Harmonised System (UNSCE GHS) which not all WTO Members are party to. 
Could the proponent please explain the intent of listing these bodies in this proposal? How would 
non-members of the OECD reconcile recognition of t est results for the purpose of this Understanding. 
Would there be an increase in the cost of doi ng business as exporters would need to send their 
chemicals to other countries for testing. What is the proponent's view on this. (Question by Malaysia) 
 
16. Although some WTO Members which are not OECD Members are presently in the process of 
adhering to OECD GLP procedures, for the benefi t of other non-OECD Members, could the EU 
clarify which are the different modes of particip ation and membership in the relevant committee 
concerning GLP in OECD? How would WTO and WTO Members which are not OECD Members TN/MA/W/140 
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  participate in the implementation of OECD proce dures for mutual acceptance of data? (Question by 
Argentina and Brazil)  - The concerns raised regarding the OECD as a reference standard setting body have been 
noted.  Given the broader participation in UNEP's Strategic Approach to International 
Chemicals Management (SAICM), the possibility of replacing the OECD by UNEP/SAICM 
in Article 2.1 will be evaluated.  We consid er the activities listed in the SAICM Global Plan 
of Action as fulfilling the criteria, in that othe r international organisations are also listed. 
 - As for the GLP aspect, please refer to the answers to question 43. 
 
17. Article 2.2 of the TN/MA/W/137 proposal states that "Members commit to participate actively (…) in the international standard-setting bodies identified in paragraph 2.1". What exactly 
does this statement mean, since admission process in so me of the institutions listed is not automatic 
and is conditional on the approval of their existi ng Members? Would developing countries be granted 
special and differentiated treatment in accordance to  Article 12 of the TBT Agreement? (Question by 
Argentina and Brazil)  - The replacement of OECD with SAICM in Ar ticle 2.1 broadens participation, including 
developing countries. By nominating a UN body, there does not seem to be any need for special and differentiated treatment since devel oping countries are already party to this body. 
 
18. Canada notes that the EU has proposed "relev ant" international standardizing bodies.  The 
TBT Agreement does not list any international sta ndardizing body in any product area as being the 
"relevant" body. Why is the EU proposing such a lis t in the area of chemicals? (Question by Canada) 
 
- Clarifying the international standard se tting bodies will enhance the convergence of 
regulations over time, thus enabling devel oping countries to better participate in these 
activities.  
 19. How was the EU's proposed list determined? (Question by Canada) 
 
- These are the main bodies dealing with the diffe rent aspects pertaining to the management of 
chemicals which are being addressed in both chemical NTB proposals. 
 20. Is this list meant to be exhaustive?  In th e case of overlapping expertise, which international 
standardizing body would be considered the competent authority? (Question by Canada) 
 
- The addition of SAICM complements the existing lis t.   The list is not meant to be exhaustive; 
however, the replacement of the OECD by  UNEP/SAICM extends participation.   
 21. Article 2.2.1 is very simila r to existing provisions of the TBT Agreement, in particular 
Article 2.6 (technical regulations), Article 5.5 (conformity assessment) and Annex 3, paragraph G 
(standards).  Could the EU please explain what Artic le 2.2.1 of the proposed Understanding adds to 
the existing obligations of WTO Members? (Question by  the Kingdom of Saudi Arabia) 
 
- Article 2.2.1 complements the existing provisi ons of the TBT Agreement and is intended to 
lead to greater regulatory harmonisation. 
 
22. Article 2.2.1 requires Members to harmonise technical regulations a nd conformity assessment 
procedures on as wide a basis as possible. Please clarif y what is meant by "wide a basis as possible".  
(Question by Malaysia)  TN/MA/W/140 
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  - Harmonisation is one of the most trade-facilita ting methods in overcoming obstacles to trade. 
"As wide a basis as possible" refers both to the range of countries participating in such 
harmonising activities as to the range of topics that could be harmonised.   
 
IV. CLASSIFICATION AND LABELLING OF CHEMICALS 
23. In Article 3 of the proposal, the EU makes reference to an obligation placed on Members to 
move towards substantial global ha rmonization of classification and labelling of chemicals by the end 
of [2015]. (Question by Canada)  - Yes, the EU would like Members to have substa ntially aligned their domestic legislation by 
the end of 2015.  This is in keeping with ot her commitments, including, SAICM.  Much effort 
is still required to meet the ambitious 2020 goa l adopted by the World Summit on Sustainable 
Development in 2002. However, the timeframe of  2015 is currently put into square brackets 
to indicate an openness to discuss. 
 
24. Under Article 3.2, please explain what the EU w ould consider to be technical regulations that 
are "substantially aligned" with the Globally Ha rmonized System. (Question by  the Kingdom of 
Saudi Arabia) 
 
- National legislation or voluntary agreements and actions should be a ligned to the largest 
degree possible whilst allowing for minor, justified divergences. 
 
25. According to Article 3.3, any Member's  classification and labelling requirements for 
chemicals shall be in conformity with Article 2.2,  2.4, and 2.5 of the TBT Agreement.  In Korea's 
view, even without Article 3.3 of the proposal, Me mber's classification and labelling requirements for 
chemicals still need to be in conformity with relevant articles of the TBT Agreement.  Does 
Article 3.3 have any other legal implicati on? (Question by the Republic of Korea) 
 
- This article has been removed. 
 26. Would this proposed obligation abrogate a member's sovereign right to regulate to 
appropriately secure the safety of its people  and/or environment? (Question by Canada) 
 
- No, the proposed Understanding is to ensure th at trade is facilitated to the greatest extent 
possible whilst continuing to allow any memb er pursuing its legitimate public policy 
objectives.  
 
27. In paragraph 3, is it correct that the propo sal requires all WTO Members to be a member in 
the Global Harmonized System of Classification and Labelling of Chemicals? If so, wouldn't the 
deadline of 2015 be considered rather tight for all members to align their technical regulations to the 
Globally Harmonized System for Classification and Labe lling of Chemicals especially if we take into 
account developing countries? (Question by the African Group)  
- The UN GHS is a non-legally binding intern ational agreement. Therefore countries (or 
regional associations) must create local or national legislation to implement the GHS. The reference in paragraph 3 does not oblige WT O Members to be a member of the Global 
Harmonised System for Classification and Labelling of Chemicals. 
 TN/MA/W/140 
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  - However, the Plan of Implementation of the World Summit on Sustainable Development 
(WSSD), adopted in Johannesburg in 2002, encourages countries to implement the GHS as soon as possible. Heads of States had set 2008 as the target date for implementation; this is why 2015 appears as a reasonable time peri od allowing members to catch up with their 
commitments made in 2002.  
 
28. Why the proposal does not include a special  technical assistance program (beyond technical 
cooperation provided in pa ragraph 11 of TN/MA/W/137 proposal) for developing countries to adapt 
their domestic legislations, so that they would be ab le to comply with Article 3.2 of the proposal, in 
accordance with the Articles 12.4 and 12.8 of th e TBT Agreement? (Question by Argentina and 
Brazil) 
 
- Technical assistance for developing countries is an important aspect of the EU NTB proposal 
on chemicals. The EU actively supports SAIC M which promotes chemical safety around the 
world. Strong emphasis is placed on capacity-build ing and technical assi stance to developing 
countries and countries with transition economies to help them manage chemicals safely. 
 
V. TECHNICAL REGULATIONS AND CONFORMITY ASSESSMENT PROCEDURES 
29. Please define the activities that would be cons idered covered by the term "management of 
chemicals." (Question by  the Kingdom of Saudi Arabia)  
- The management of chemicals covers the t esting and hazardous assessment of chemicals - 
key elements of any management system.  The intention is not to harmonise chemical 
management systems, but rather to focus on th e convergence of technical standards used in 
the management of chemicals. 
 
30. Article 4.1.1 stipulates that Members recognize the importance of achieving global 
harmonization of the management of chemicals.  In  Korea's view, the scope of the "management" is 
overly wide or ambiguous.  Members'  technical regulation policy, as a whole and in principle does not 
need to be regulated under the WTO system, if it is  not more trade restrictive than necessary under the 
TBT Agreement.  What is the proponent's view on this point? (Question by the Republic of Korea) 
 
- Reply as for Question 29 above. 
 31. Paragraph 4.1. stipulates the importan ce of achieving global harmonisation of the 
management of chemicals. Malaysia is of the vi ew that this is an ambitious goal. How does the 
proponent envisage achieving this target? (Question by Malaysia) 
 
- In line with the reply as for Question 29 a bove, convergence of technical standards underlying 
the management of chemicals appears to be w ithin the remit of what can realistically be 
achieved. 
 32. Article 4.1.2 would impose national treatme nt and MFN obligations.  However, the TBT 
Agreement currently imposes national treatment and MFN obligations with respect to regulations 
(Article 2.1), standards (paragraph D of A nnex 3) and conformity assessment procedures 
(Article 5.1.1).  What does Article 4.1.2 of the pr oposed Understanding add to the existing obligations 
of the TBT Agreement? (Question by  the Kingdom of Saudi Arabia) 
 
- Indeed the proposal's obligations are already la id down in the TBT Agreement. However, in 
the context of a specific Understanding for chemicals, it was seen appropriate to recall a number of fundamental rules on non-technical barri ers to trade. It is particularly important  TN/MA/W/140 
 Page 7 
 
 
  that there should be no discrimination as re gards the origin of chemicals and their 
management for the aspects addressed by the proposal. 
 33. Article 4.1.2 refers to "like chemicals". Wh at is understood by this expression and how should 
chemicals be classified, considering that Article 2.1 of TBT refers to "like products". (Question by 
Argentina and Brazil) 
 - Please see answer to question 32. The use here of  "like chemicals" is exactly the same as that 
of "like products" in the TBT Agreement, thou gh here the definition of chemicals is more 
specific due to the industry-speci fic nature of the NTB proposal. 
 
34. Please explain what the EU considers to be "full and comprehensive" protection of 
confidential business information, as provided in Artic le 4.1.4. (Question by  the Kingdom of Saudi 
Arabia) 
 
- The obligation not to divulge confidential business information goes beyond the obligation 
laid down in the TBT Agreement (Art. 5.2.4), which requires members to respect information 
about products originating in another member  in the same way as for domestic products. 
 35. Article 4.1.5, which covers information re quirements, references Article 2.2 of the TBT 
Agreement.  Could the EU please explain what this provision adds to the existing disciplines of the 
TBT Agreement? (Question by  the Kingdom of Saudi Arabia) 
 
- The basic obligations in Article 4.1.5 are alr eady laid down in the TBT Agreement. However, 
in the context of a specific Understanding for chemicals, it was seen appropriate to recall a 
number of fundamental rules on non-technical ba rriers to trade. The proposed provision 
highlights the importance of information for the management of chemicals and elaborates on 
the disciplines of 2.2 TBT Agreement with regard to good regulatory practices of evaluating other means in pursuing legitimate public policy objectives. 
 36. What requirements on the collection and registration of data are envisaged under Article 4.2.1?  Please also explain the "legitima te public policy objectives" referred to in this 
paragraph. (Question by  the Kingdom of Saudi Arabia) 
 - This obligation would apply when members la y down rules requiring enterprises to collect 
and register information about chemicals which th ey sell, import or use in their territories.  
This is necessary to ensure the prot ection of health and environment. 
 
- "Legitimate public policy objectives" are those re ferred to in Art. 2.2 of the TBT Agreement. 
 37. The first sentence of Article 4.2.3 references both "collection" and "registration" of data in its 
opening scope clause, but references only "registration"  in the subsequent clau se that establishes the 
proportionality obligation.  Does the proportionality ob ligation apply only to registration, or to both 
collection and registration?  Is the proportionality ob ligation limited to the determination of costs and 
the application of procedures, or would it requi re compliance with the substantive obligations 
imposed by Article 2.2 of the TBT Agreement?  (Question by  the Kingdom of Saudi Arabia) 
 
- The collection of data would be carried out by companies privately and the cost is highly 
depended on the efficiency and the qualification of the company's management. The cost of 
data collection can therefore be established by public authorities. By contrast, registration of data with a public authority may entail a fee or other costs directly under control of the public 
authority. The proportionality principle in this c ontext refers to the level of the fee or other 
mandated costs. TN/MA/W/140 
Page 8  
 
  - The provisions in this proposal would be w ithout prejudice to the application of the TBT 
Agreement, and in particular Art. 2.2. 
 38. In paragraph 4.2, what is the scope of the da ta collection and registration obligations that will 
be considered not more trade restrictive th an necessary? (Question by the African Group) 
 
- Article 4.2.4 specifies that Members should, wh en determining the appropriate level of data 
collection, take into account the objective of  minimising negative trade effects, while 
ensuring human health and environment. 
 
39. Item 4.2.3 states that Members should ensure that the costs and pro cedures associated with 
the collection or registration of da ta are proportionate with regard to the legitimate objectives pursued, 
taking into account the impact of such costs for small and medium companies. How would the EU 
envisage this proportionality to be  assessed in order to prevent that  unnecessary barriers to trade are 
disguised as legitimate objectives? (Question by Argentina and Brazil) 
 
- One possibility would be to consider an Im pact Assessment by any member regulating 
collection or registration of data that woul d be publicly accessible to other members. 
 40. Would the proponent explain what type of data  that will be needed to enable registration 
according to this proposal? (Question by the African Group)  
- The Understanding is neutral on this aspect sinc e it will need to be decided by regulators in 
member countries. It depends on what data is re quired for the regulatory policy objective.  If 
for e.g. legislation requires certain toxicity da ta, then the proposal would require the data to 
be generated according to agreed technical standards. 
 
41. Concerning paragraphs 4.2.6,  and 4.2.7, please explain why registration requirements would 
apply only to imported products. (Q uestion by Argentina and Brazil) 
 - In the latest (June 2010) version, 4.2.6 and 4. 2.7 cover the registration of data for chemicals 
contained in articles. Following comments from a number of delegations and in line with the 
fundamental WTO principle of non discriminati on between domestic and imported products, 
the NTB proposal was revised accordingly. 
 42. In Articles 4.2.6 and 4.2.7, how is "released" to be defined? (Question by  the Kingdom of 
Saudi Arabia) 
 
- The objective is to limit registration obligations  on chemicals when they are contained in 
articles to two cases, i.e. when the chemical is  intended to be released, that is, removed or 
separated from the article, or when the article  contains a particularly hazardous substance 
which can pose an important risk for health or the environment. 
 
43. Article 4.3.1 incorporates certain OECD standards for conformity assessment.  Please clarify 
why this is necessary in light of the fact that OE CD principles apply only to a small subset of the 
WTO Membership. (Question by  the Kingdom of Saudi Arabia)  - In the areas of testing, data acceptance and good laboratory practice, the OECD has a long 
history of experience in developing harmonised common tools. The OECD Guidelines for the 
Testing of Chemicals are recognised internationa lly as the standards for testing of chemicals 
and are used to support chemical safety regula tions in many countries. The OECD Principles 
of Good Laboratory Practice (GLP) complement the OECD Test Guidelines by setting quality 
standards for the organisation and management of test facilities and for performing studies.  TN/MA/W/140 
 Page 9 
 
 
  The GLP Principles are accepted worldwide as th e quality standard for environmental health 
and safety testing of chemicals. The OECD's  work in this area already involves many 
non-OECD countries. In particular, the OECD Mutual Acceptance of Data (MAD) system, 
which incorporates the OECD Test Guidelines and the OECD GLP Principles, is open to 
non-OECD members since 1997. 
 
- Whilst there is no intention to promote the OE CD as such in the NTB proposal, the proponent 
considers that building on the experience acqui red in this context, inviting more WTO 
Members to participate in this work and make u se of the principles, would facilitate trade and 
would therefore benefit all countries, developing or  developed alike, to further integrate in the 
global trade of chemicals. 
 44. Please explain how Article 4.3.2 of the U nderstanding is substan tively different from 
Article 5.1.2 of the TBT Agreement. (Question by  the Kingdom of Saudi Arabia)  
- The basic obligation in Article 4.3.2 is alread y laid down in the TBT Agreement. However, in 
the context of a specific Understanding for chemicals, it was seen appropriate to recall a number of fundamental rules on non-technical barriers to trade.  
 45. Article 4.3.4 of the Understanding sets out oblig ations with respect to sampling, which by its 
own terms would be "[i]n accordance with Arti cle 5.1.2 of the TBT Agreement"  However, 
Article 4.3.4 of the Understanding includes concepts  that are not found in Article 5.1.2 of the TBT 
Agreement, including in the last sentence with  respect to proportionality.  Please explain how 
Article 4.3.4 of the Understanding is  substantively different from Article 5.1.2 of the TBT Agreement. 
(Question by  the Kingdom of Saudi Arabia)  
- In principle, the obligations in Article 4.3. 4 are already laid down in the TBT Agreement. 
However, in the context of a specific Understanding for chemicals, it was seen appropriate to recall a number of fundamental rules on non-techni cal barriers to trade, and in this case make 
reference to sampling. The concept of propor tionality builds on the concepts included in 
Art. 2.2 of the TBT Agreement. 
 VI. MUTUAL ACCEPTANCE OF DATA 
46. In paragraph 5, it would be useful if the EU gives further explanation on the terms and 
conditions of the plurilateral system of Mutual Acce ptance of Data in the assessment of chemicals as 
established by the Council of the Organization fo r Economic Co-operation a nd Development (OECD) 
on 12/5/1981 and the relevant Council acts established by the Council's decision of the OECD of 
26/11/1997 referred to in paragraphs 5.2 and 5.3 respectively. (Question by the African Group) 
 - Both decisions are available on the internet at the following addresses: 
 - Decision of the Council concerning the Mutual Acceptance of Data in  the Assessment of 
Chemicals on 12/5/1981: 
 
http://webnet.oecd.org/oecdacts/ Instruments/ShowInstrument View.aspx?InstrumentID=263&
InstrumentPID=263&Lang=en&Book= 
 - Decision of the Council concerning the Mutual Acceptance of Data in  the Assessment of 
Chemicals on 26/11/1997: 
  http://webnet.oecd.org/oecdact s/Instruments/PrintInstrumentView.aspx?InstrumentID=65&In
strumentPID=62&InstrumentHID=0&Lang=en TN/MA/W/140 
Page 10  
 
  47. Please indicate how Members would determine whether the criteria enumerated in Article 5.1 
have been fulfilled, particularly with respect to determining whether the requirements are "equivalent" 
and whether a Member's data registration fulfils  the "same legitimate objectives."  Does the EU 
consider that such criteria would be addressed thr ough mutual recognition agreements? (Question by  
the Kingdom of Saudi Arabia) 
 
- The purpose of our proposal is to reduce barriers to trade where this is technically feasible. 
This article intends to encourage countries to  identify trade partners where they would 
generally consider that the registration dossiers of the trading partner to be of equivalent 
content and hence be acceptable as such for registration purposes. Equivalence is established 
by the regulatory authorities of the accepting memb er. It is not foreseen that this would lead 
to mutual recognition agreements, but rather to clear indications to industry of which 
registration dossiers of trading partners would be in principle sufficient also for the registration of the said country.  
 
48. Articles 5.2 through 5.4 seek to use OECD criteria.  Again, could the EU explain why 
non-OECD Members should adopt such criteria?  More particularly, please explain why non-OECD 
members "shall endeavour to adhere" to OECD st andards on the mutual acceptance of data under 
Article 5.3. (Question by  the Kingdom of Saudi Arabia)  - The OECD co-ordinates the only internationa l programme which ensures that laboratories 
meet standards which guarantee that th e data generated from them are accepted by 
participating members. Since 1997, participati on in the programme is also open to non OECD 
countries, "with the same rights and obligations" as OECD member countries. By adhering to the standards of mutual acceptance of data, all data generated according to the rules of OECD 
will under our proposal be acceptable for use in registrations world wide and thereby reduce 
the costs for generating data.   
 49. In paragraph 5.1.c, what does "the intern ationally agreed data reporting format" means? 
(Question by Argentina and Brazil).  - For each test guideline adopted in the framewo rk of the OECD, data reporting formats were 
agreed. Adhering to and accepting such data repor ting formats reduces the need to reformat or 
re-summarise data and hence increases signi ficantly the efficiencies gained. A further 
advantage is that International Council of Chemical Associations (ICCA) uses these data 
formats for their international programmes. IC CA is the world-wide voice of the chemical 
industry, representing chemical manufactu rers and producers all over the world. 
 
50. Article 4.3 of the proposal establishes speci fic OECD decisions as a reference. How would 
future modifications of those disciplines affect rights and obligations of WTO Members which are not 
OECD Members? (Question by Argentina and Brazil)  - As the OECD programme on Mutual Acceptanc e of Data is open for non OECD members, 
we would foresee that the changes in standa rds adopted through the OECD processes, are 
extended to all those non OECD countries who adhere to the mutual acceptance of data 
programme. 
 51. How would concerns of other WTO Members which are not OECD members be taken into 
account in the future evolution of the disciplin es established by the OECD Council? (Question by 
Argentina and Brazil)   TN/MA/W/140 
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  -  As mentioned above, non OECD countries whic h adhere to the mutual acceptance of data 
system can be members of the programme and hence be an active participant in determining the future evolution of the disciplines. 
 52. Would the EU be open to a formulation that  would not transpose OECD standards into WTO 
disciplines, but recognize the importance of plurilat eral arrangements in this area? (Question by 
Argentina and Brazil)  -  We would be open to discuss other options capable of achieving the same objectives. Our 
proposal is based on the assumption that each country  can set the level of protection that they 
see is necessary for their territories. If the legal or voluntary frameworks which a country 
would implement to meet that level of protection envisages a registration system, then our proposal proposes is not to harmonise those regist ration requirements, but rather to establish a 
system of mutual recognition of data for those data elements which are included in the national frameworks. This enables an efficient exchange of information leading to a reduction 
in obstacles to trade and a reduction of costs for the industries concerned, whilst enabling 
each country to set its registration requiremen ts as it sees fit to suit its desired level of 
protection.  
 
VII. TRANSPARENCY, GOOD REGULATORY PRACTICE, JUDICIAL REVIEW 
53. Please provide specific information on what  commitments would be assumed by Members 
with respect to "good regulatory practice" under Article 7.1. (Question by  the Kingdom of Saudi 
Arabia)  - The good regulatory practice commitments ar e in line with what is proposed in the 
Framework Understanding on Non-Tariff Barriers as proposed by Brazil, EU, India. With 
regard to the chemicals industry-specific NT B proposal, the EU is proposing to add the 
consideration of the 2020 goals of the Johannes burg Plan of Implemen tation in paragraph 23 
which can be accessed under the following web address:  
  http://www.un.org/esa/sustdev/documents/WSSD_POI_PD/English/WSSD_PlanImpl.pdf  
54. Concerning paragraph 7.1.c of TN/MA/W/137 proposal, does it include impact evaluation 
assessments concerning economic and social aspec ts, especially those related to labelling and 
registration of chemicals for international trade?  Why is there no mention to special conditions 
involving developing countries? (Question by Argentina and Brazil)  
- It would include those concepts mentioned, a nd in considering international trade as one of 
them, developing countries would be included in the assessment. 
55. Please explain the phrases "good faith" and "substantial effect on the trade of another 
Member" in Article 8.1. (Question by  the Kingdom of Saudi Arabia)  - These are concepts that are already included in the TBT Agreement, and as such require no 
further elaboration.  
 56. Article 9, which provides for "judicial or quasi-judicial" review, has parallels in the WTO 
covered Agreements, such as GATT Article X:3(b) and Article 5.2.8 of the TBT Agreement.  Please explain the application of this proposed provision in the context of trade in ch emicals.  Does the EU 
consider Article 5.2.8 of the TBT Agreement, whic h deals with conformity assessment procedures, to 
be inadequate? (Question by  the Kingdom of Saudi Arabia) 
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  - Article 9 is an expansion and specificati on of Art. 5.2.8 TBT Agreement and of GATT 
Article X:3b, referring to the final administrativ e decisions relating to technical regulations 
and conformity assessment procedures being subject to judicial or quasi-judicial review that is available, transparent and impartial.  It is fu lly in line with the discipline proposed in the 
Framework Understanding on Non-Tariff Barriers as proposed by Brazil, EU and India. 
 
57. What does the EU understand to be meant by the "due process" standard set out in this 
proposed provision? (Question by  the Kingdom of Saudi Arabia)  - The legal definition of "due process" - the idea that laws and legal proceedings must be fair. 
 
VIII.  CONFIDENTIAL INFORMATION 
58. Article 10, which provides for the protection of confidential information, also has parallels in 
the covered Agreements, such as GATT Article X.  Please explain how the application of this proposed provision is necessary in the context of tr ade in chemicals. (Question by  the Kingdom of 
Saudi Arabia) 
 - The protection of confidential information is  extremely important for businesses, and the 
general statement emphasises that nothing in the understanding should be  construed to be 
contrary to it. 
 IX. SPECIAL AND DIFFERENTIAL TREATMENT  
59. In article 4.1.3, the EU refers to special and differentiated treatment  for small and medium 
enterprises with a view to reducing the administra tive burden for them. How does the EU plan to 
implement S&DT for SMEs while ensuring an appr opriate level of security for human, animal and 
plant life or the environment? (Question by Canada)  
 
- For example, the collection of data would be done by companies privately and the cost would 
not be established by public authorities. By c ontrast, registration of data with a public 
authority may entail a fee. In this case, cons ideration could be given for reduced fees for 
SMEs. 
 X. SUBCOMMITTEE OF TBT COMMITTEE ON CHEMICALS 
60. With respect to monitoring and oversight, there are a number of other fora, such as UNEP, 
which already deal with chemicals in terms of their environmental impact. What role does the EU foresee the Subcommittee playing? (Question by Canada)  
- While there are other fora as stated, on the assumption that this Understanding would take 
effect, it would make sense to monitor its operation by WTO Members.  
 61. What benefit(s) does the EU expect would be derived by Members from establishing such a 
subcommittee? (Question by Canada)  
- A better understanding of its us e and effectiveness, making sure that the NTB Understanding 
on chemicals is fully implemented by WTO Members 
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  62. Please explain how the work of the Subcomm ittee on Chemicals would be different from, or 
would complement, the work of the TBT Committee to which it would report. (Question by  the 
Kingdom of Saudi Arabia)   - The Subcommittee would complement and not  duplicate the work of the TBT Committee. 
 
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