WORLD TRADE  
ORGANIZATION  TN/MA/W/137/Rev.1 
23 June 2010 
 (10-3430) 
Negotiating Group on Market Access Original:   English 
  
 
MARKET ACCESS FOR NON-AGRICULTURAL PRODUCTS 
 
Negotiating Text
 
 
Understanding on Non-Tariff Barriers Pertaining to Standards, Technical Regulations and  
Conformity Assessment Procedures for Chemical Products  
 
Communication from the European Union 
 
Revision  
 
 The following communication, dated 21 June 2010,  is being circulated at the request of the 
delegation of the European Union. It contains a number of precisions resulting from the discussions 
and in response to comments by delegations.  
_______________ 
 
 
Understanding on Non-Tariff Barriers Pertaining to Standards, Technical Regulations and 
 
conformity Assessment Procedures for Chemicals  
 
Members, 
 
Recalling that pursuant to paragraph 16 of the Doha Ministerial Declaration, Members agreed 
to negotiations aimed at reducing or as appropriate  eliminating tariffs and non-tariff barriers on 
non-agricultural products, 
 
 Recognizing the important contribution of chemical s to global economic growth, trade and 
sustainable development, in particular its signi ficance for the economies of developing countries, 
 
 Renewing  their commitment, as advanced in Agenda  21, to sound management of chemicals 
throughout their life cycle and of hazardous wastes  for sustainable development as well as for the 
protection of human health and the environment, inter alia , aiming to achieve, by 2020, that 
chemicals are used and produced in  ways that lead to the minimiza tion of significant adverse effects 
on human health and the environment,  
 
 Acknowledging  that the chemical industry is essential for a wide variety of manufacturing 
and agricultural industries and bearing in mind its co ntribution to the transfer of advanced technology, 
whilst noting that parts of  these chemical indus tries are composed of small and medium-sized 
enterprises,  
Affirming their existing rights and obligations under the WTO Agreement, including the 
Agreement on Technical Barriers to Trade (TBT Agreement), 
 TN/MA/W/137/Rev.1 
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  Recognizing that no Member should be prevented from taking measures that are necessary 
for the protection of human, animal or plant life or health, for the protection of the environment, or 
for the prevention of deceptive practices, at the levels it considers appropriate, subject to the 
requirement that they are not applied in a manne r which would constitute a means of arbitrary or 
unjustifiable discrimination between countries or a dis guised restriction on international trade, and are 
otherwise in accordance with the pr ovisions of this  Understanding; 
 
Desiring to ensure that technical regulations, standards, and conformity assessment 
procedures are not designed, neither adopted, nor applied so as to create unnecessary obstacles to 
international trade in chemicals; 
 
Reaffirming the commitment to  the conclusions of the World Summit on Sustainable 
Development in Johannesburg of 2002 encouragi ng Members to implement the Globally Harmonized 
System of Classification and Labeling of Chemicals (GHS) as soon as possible, 
 
 Confirming  their shared objectives and principles of: 
 
- establishing competitive market conditions based on principles of openness, 
non-discrimination, and transparency; 
- ensuring  a high level of protection of human health and the environment; - enhancing international cooperation to foster continued beneficial development in trade; 
- promoting the development of alternative met hods for assessment of hazards of substances 
and reducing animal testing as well as burde n on manufacturers on the basis of available 
information; 
- implementing appropriate regulatory mechanis ms and protecting confidential information; 
- contributing to the fulfillment of the Stra tegic Approach to International Chemicals 
Management (SAICM), and 
- developing and promoting b est practices on hazard and risk assessment of chemicals and 
chemicals management  globally, 
 
Recognizing,  based on the objectives and principles above  and with a view to facilitating and 
promoting trade, the importance of: 
 
- ensuring transparency regarding the content of  their laws, regulations and other measures of 
general application in the area of chemicals,   
- providing transparency and due process when regulating and operating their chemical 
management regimes,  
- applying, whenever possible, best practices w ith respect to the adoption and implementation 
of  regulations concerning ma nagement of chemicals, and 
- cooperating in the development of interna tional standards on good laboratory practice and 
testing, in order to seek more harmonized appr oach to chemical assessment and management, 
  Recognizing that no country should be prevented from taking measures necessary to fulfill its 
legitimate objectives in accordance with the provision s of Article 2.2 of the Agreement on Technical 
Barriers to Trade,  
  TN/MA/W/137/Rev.1 
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  The Members, 
Agree as follows:  
 
1. SCOPE AND COVERAGE 
1.1 This Understanding shall apply with resp ect to chemicals in HS Chapters [28-39]1. 
1.2 Members assume obligations under this Agreemen t only with respect to standards, technical 
regulations and conformity assessment procedures. 
1.3 This Understanding shall not apply to purch asing specifications prepared by governmental 
bodies for production or consumption requirements of governmental bodies. 
 
STANDARDS, TECHNICAL REGULATIONS, 
AND CONFORMITY ASSESSMENT PROCEDURES 
2. INTERNATIONAL STANDARDIZATION AND REGULATORY 
HARMONIZATION 
 
2.1 International Standard-Setting Bodies 
 
For the purpose of applying Articles 2.4, 5.4 and point F of Annex 3 of the Agreement on 
Technical Barriers to Trade, with regard to the areas of testing, data acceptance and good laboratory 
practice the Organisation for Economic Co-operati on and Development (OECD), in relation to the 
classification and labelling of chemicals the Un ited Nations Subcommitt ee of Experts on GHS 
(UNSCE GHS) under the auspices of UN Economic and Social Council, and otherwise the 
International Organization for Standardization (IS O) shall be considered the main relevant 
international standard-setting bodies.   
2.2 Regulatory Harmonisation 
 
2.2.1 With a view to harmonizing technical regul ations and conformity assessment procedures on 
as wide a basis as possible, Members shall play a full part, within the limits of their resources, in the 
preparation by appropriate international standardiz ing bodies of international standards, guides and 
recommendations pertaining to chemicals.  
2.2.2 Members commit to participate actively in th e development of international standards, guides 
and recommendations, and shall cooperate for the adop tion, without undue delay, of new international 
standards, guides and recommendations by rele vant international standard-setting bodies. 
 
2.3 Development of International St andards, Guides and Recommendations 
  For international standards to make a maxi mum contribution to the achievement of trade 
facilitation for the chemicals under this Understanding, Members confirm the importance they attach 
to the principles announced in the Decision of the WTO Committee on Techni cal Barriers to Trade on 
Principles for the Development of International Standards, Guides and Recommendations with 
relation to Articles 2, 5 and Annex 3 of the Agreement .
2 
 
                                                      
1 To be agreed by Members. 
2  Annex B of the Document G/TBT/1/Rev. 9 dated 8 September 2008 . TN/MA/W/137/Rev.1 
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  3. CLASSIFICATION AND LABELING OF CHEMICALS  
 
3.1  Members recognise the importance of achie ving global harmonisation of the classification 
and labelling of chemicals and the progress achieved with the establishment of the Global Harmonized System of Classification and Labelling of Chemicals.  
 
3.2 Members shall gradually align their technical regulations to the Globally Harmonized System of Classification and Labeling of Chemicals with a vi ew to having substantially aligned their domestic 
legislation by the end of [2015].   4. TECHNICAL REGULATIONS AND CONFORMITY ASSESSMENT PROCEDURES 
 
4.1 Management of Chemicals  
 
4.1.1 Members recognise the importance of achievi ng global harmonisation of the management of 
chemicals.  
 4.1.2 Members shall ensure that in respect to regulations and conform ity assessment procedures 
relating to management of chemicals, chemicals imported from the territory of any Member shall be accorded treatment no less favourable than that accord ed to like chemicals of national origin and to 
like chemicals originating in any other country. 
 
4.1.3 Any Member shall endeavour to provide in its regulations and conformity assessment 
procedures relating to chemicals for small and me dium enterprises with a view to reducing the 
administrative burden for them.  
4.1.4 Any Member shall ensure that its regula tions and conformity assessment procedures ensure 
full and comprehensive protection of confidential business information.   4.1.5 In accordance with Article 2.2 of the Agre ement on Technical Barriers to Trade, any Member 
that is planning to establish regul ations relating to chemicals, shall ensure that the information 
required cannot be obtained by other means that woul d be less trade-restrictive to fulfil the legitimate 
public policy objective. 
 
4.2 Registration of Data 
 
4.2.1 Members recognise that the current knowledge  of hazards deriving from chemicals for safety, 
health and the environment requires the collection of data and scientific ev idence of their hazardous 
effects to allow a proper assessment of the risks as sociated with their handling and management. For 
this purpose, requirements on collection and registra tion of data may be set up by any Member in 
view of pursuing their legitimate public policy objectives.  4.2.2 Members shall ensure that in respect to registration of data,
3 chemicals under the coverage of 
this Understanding imported from the territory of  any Member shall be accorded treatment no less 
favourable than that accorded to like chemicals of na tional origin and to like chemicals originating in 
any other country.  
                                                     
 
3 Registration of data means any submission of information concerning chemicals to a national or 
regional authority as part of a regulatory and non-re gulatory scheme. It therefore covers, for example, 
notification schemes for new substances and chemical registration schemes.  TN/MA/W/137/Rev.1 
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  4.2.3  When a Member designs, adopts or appli es a technical regulation requiring collection or 
registration of data for chemicals covered by this  Understanding, it shall ensure that costs and 
procedures associated with registration of data are proportionate with regard to the legitimate 
objectives pursued according to Article 2.2 of the TBT Agreement. In particular, the impact of such 
costs for small and medium companies shall be taken into account.  
 
4.2.4 Members should, when determining the appropria te level of data collection, take into account 
the objective of minimizing negative trade effect s whilst meeting the objectives of the measure. 
 4.2.5  When data and scientific information and evidence of their hazardous effects become 
available through the data collection process itself, the Member shall periodically review the scope of 
the data collection and registration obligations on th e basis of this new information with a view to 
evaluating if the circumstances or objectives giving rise to the definition of that data collection scope 
continue to exist or can be addressed in a less trade-restrictive manner.  
4.2.6  Members may require registration of data for chemicals contained in articles when the 
chemicals are intended to be released.  4.2.7  Members may require registration of data for chemicals contained in articles when the chemicals are not intended to be released, if ther e is sufficient scientific evidence that, because of 
their intrinsic properties, the chemicals in those articles pose a risk for human, animal, plant health 
and life, or the environment. 
 
4.3 Testing and Sampling of Chemicals  
 
4.3.1 If a Member requires a positive assurance of c onformity for a chemical, in accordance with 
Article 5.4 of the Agreement on Technical Barriers to Trade, any government body of this Member 
shall use, require or accept the use of test me thods for conformity assessment conforming with 
technical regulations or standards, and relevant guides or recommendations issued by international 
standardising bodies or conforming with the prin ciples of Good Laboratory Practice (GLP) and the 
Guidelines for the testing of chemicals as established by the Council of the Organisation for 
Economic Co-operation and Development on 12.05.1 981 (C(81)30/Final) and with the principles of 
Good Laboratory Practice as adopted by the Council  of the Organisation for Economic Co-operation 
and Development on 02.10.1989 (C(89)87/Final), respectively.   
4.3.2 In accordance with Article 5.1.2 of the Agreement on Technical Barriers to Trade, any 
procedure to assess the conformity of a chemical shall not be more strict or be applied more strictly than is necessary to give the importing Member ad equate confidence that such chemicals conform 
with the applicable technical regulations or standards.  
4.3.3 Members shall neither require any re-certification, nor any re-declaration for chemical 
substances which have not change d from the moment of their first certification or declaration. 
4.3.4 In accordance with Article 5.1.2 of the Agreement on Technical Barriers to Trade, any 
sampling required by a Member to establish a pos itive assurance of conformity shall not be more 
strict or be applied more strictly than is necessar y to give the importing Member adequate confidence 
that the chemicals conform with the certificates or  declarations provided by the manufacturer or 
supplier. The sampling methods shall be proportionate  to the risks non-conformity would create.  TN/MA/W/137/Rev.1 
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  5. MUTUAL ACCEPTANCE OF DATA 
 
5.1 Any Member shall give positive consideration to accept registrations of data that originate 
from any other Member when:  
(a) it has an equivalent level of requirements; and 
(b) it fulfils the same legitimate objectives; and (c) it uses the internationally agreed data reporting format.   With this purpose, Members shall also pa rticipate in international initiatives aimed at 
harmonizing registration of data requirements. 
 5.2 Whenever possible, Members shall strive to adhere to the plurilateral system of mutual 
acceptance of data in the assessment of chemicals as  established by the Council of the Organisation 
for Economic Co-operation and De velopment on 12.05.1981 (C(81)30/Final) according to the rules 
and procedures thereof. 
 5.3 Members that are not yet members of th e Organisation for Economic Co-operation and 
Development shall endeavour to adhere to the Council  acts related to the mutual acceptance of data in 
the assessment of chemic als according to the procedure estab lished by the Council decision of the 
Organisation for Economic Co-operation and De velopment of 26.11.1997 (C(97)114/Final).  
 
5.4 Members that are part of the plurilateral  system of mutual acceptance of data in the 
assessment of chemicals as referred to in paragraph 5.1 shall accept test data generated by an accredited laboratory of another Member in accord ance with the Good Laboratory Practice (GLP) 
principles as soon as that Member has adhered to  the system in accord ance with its rules and 
procedures and has issued the assurance of GLP Compliance according to the Council decision on 
compliance with principles of Good Laboratory Practice as adopted by the Council of the 
Organisation for Economic Co-operation and Development on 02.10.1989 (C(89)87/Final). 
TRANSPARENCY, PROCEDURES FOR JUDICIAL REVIEW,  
AND CONFIDENTIAL INFORMATION 
 
6.  TRANSPARENCY  
[Disciplines as resulting from the horizontal discussions on transparency.] 
7. GOOD REGULATORY PRACTICE 
 
7.1 Where a Member prepares or proposes to adopt a technical regulation or conformity 
assessment procedure covering registration of data and a relevant international standard or a relevant 
guide or recommendation issued by an internati onal standardizing body does not exist, it shall: 
 (a) consider, inter alia , the commitment to achieve the 2020 goa l articulated in paragraph 23 of 
the Johannesburg Plan of Implementation  
(b) assess the available regulatory and non-regul atory alternatives to the proposed technical 
regulation or conformity assessment procedur e that may fulfill the Member's legitimate 
objective  in accordance with Article  2.2 of the TBT Agreement, and 
(c) consider, inter alia , the impact of  the proposed techni cal regulation or conformity assessment 
procedure on interested parties as well as its impact on international trade; and 
 
7.2  The requirements in paragraph 7.1 do not impl y any determination on the way or format this 
consideration shall take.  TN/MA/W/137/Rev.1 
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  7.3 Each Member shall establish or maintain pr ocedures for it to review, at regularly-scheduled 
intervals, its technical regulations and conform ity assessment procedures to determine whether such 
measures should be modified or eliminated so as to make the Member's regulatory program more effective in achieving the legitimate objective(s) pursued.   8. REGULATORY COOPERATION 
 
8.1 Members agree to discuss in good faith an y issues arising from the application of any 
Member’s regulation on chemicals that have a subs tantial effect on the trade of another Member. 
 
8.2 The authorities of Members responsible for re gulating chemicals shall endeavour to enhance 
their regulatory cooperation on a multilateral level to share experiences, inter a lia, in the application 
of regulatory matters under this Understanding with a view to f acilitating trade whilst enhancing 
regulatory practices. Participating Members shall report on the outcome of their cooperation to the 
Subcommittee established under Article 12. 
 
9. PROCEDURES FOR JUDICIAL REVIEW 
 
 Each Member shall make available transparent and impartial judicial or quasi-judicial review 
of final administrative decisions relating to technical regulations and conformity assessment 
procedures that follows due process. Each Member shall ensure that any entity entrusted with such 
review does not have any substantial interest in the outcome of the matter. 
 
10. CONFIDENTIAL INFORMATION 
 
 Nothing in this Understanding shall be constr ued to require a Member to furnish or allow 
access to confidential information or business secret s, the disclosure of which would impede law 
enforcement or otherwise be contrary to the pub lic interest or which would prejudice the legitimate 
commercial interests of particular ec onomic operators, public or private. 
 
11.  TECHNICAL ASSISTANCE 
 11.1 As provided for by Article 11 of the TBT Agreement, developed country Members shall 
provide, on request and on mutually agreed terms and conditions with devel oping and least-developed 
country Members, technical cooperation in the implementation of the commitments under this 
Understanding.   
11.2  Members shall endeavour to take effective actions in order to promote the exchange of 
technical expertise, experience and information w ithin the context of the technical regulations, 
standards and conformity assessment procedures applicable to chemicals covered by this Understanding.  11.3 Developed Member countries shall provide , upon request and under terms and conditions 
mutually agreed with developing countries and l ess developed countries, technical cooperation to 
assist compliance with registration of data requirements and with mutual acceptance of data agreements.  TN/MA/W/137/Rev.1 
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  ADMINISTRATION, DISPUTE SETTLEMENT AND FINAL PROVISIONS 
 12. MONITORING AND OVERSIGHT 
12.1 A Subcommittee on Chemicals (Subcommittee) is hereby established as a subcommittee to 
the TBT Committee to oversee the operation and im plementation of this U nderstanding and further 
its objectives and to provide a forum for discussions  on any matter related to  this Understanding.  
The Subcommittee shall:  
(1) comprise representatives of each Member, in cluding from its regulatory authorities; 
(2) elect its own Chairman and apply the TBT Committee working procedures; (3) meet, at least every [five] years, to re view the implementation and operation of this 
Understanding (a) and share experiences, inter a lia, in the application of regulatory matters 
under this Understanding with  a view to facilitating trad e whilst enhancing regulatory 
practices;  
(4) report to the TBT Committee with a view to complementing and not duplicating the work of 
that Committee and, to this end, communicate to  the TBT Committee the results of its review 
conducted pursuant to subparagraph (3); and 
(5) update Annex 1 in accordance with the provisions in paragraph  4.3.1. 
 
13. DISPUTE SETTLEMENT 
 
 Article 14 of the TBT Agreement shall apply mutatis mutandis to this Understanding.   
 
[Note: Need to further consider relationship with Dispute Settlement Understanding] 
 
14. FINAL PROVISIONS 
 
[Note: Need to consider final provisions to be included in this Understanding, such as entry into 
force, withdrawal, amendment, WTO Secret ariat to service Understanding, deposit etc.] 
 
15. DEFINITIONS 
 
Chemicals  means all products considered under the Strategic Approach to International 
Chemicals Management (SAICM) of the United Nations Environment Programme (UNEP), i.e. 
chemicals, including in articles, ex cept 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. 
 
 Article means a manufactured object formed to a specific shape or design relevant to its 
function. An article undergoes no change of chemical  composition or form during its use, other than 
that which is incidental to its use, that which is an intrinsic part of its use, or that which has no 
commercial purpose separate from that of the article. ("Guidance on definitions of key terms for new 
chemical notification", OECD ENV/JM/MONO(2007)13 of 20.06.2007).  
  
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