RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/129/Rev.1
11 May 2000
(00-1928)
PROJECT FOR "AN INTERNATIONAL MODEL FOR IMPLEMENTING GOOD
REGULATORY PRACTICE FOR THE PREPARATION, ADOPTION AND
APPLICATION OF TECHNICAL REGULATIONS VIA THE USE
OF INTERNATIONAL STANDARDS”
Communication from the United Nations Economic Commission for Europe
Revision
The following Communication has been received from the secretarial of the UN/Economic
Commission for Europe with the request that it be circulated to WTO Members  for information on
UN/ECE activities relating to the elimination of technical barriers to trade.
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It is recalled that the outline of the attached UN/ECE project was submitted for information of
the TBT Committee on 25 February 2000 (document G/TBT/W/129 of 22 March 2000).
This project was prepared by the UN/ECE ad hoc team of specialists on standardization and
regulatory techniques (START Team) which works under the auspices of the UN/ECE Working Party
on Technical Harmonization and Standardization Policies (Working Party 6).  This revised versiontakes into account comments on the outline of the project made at the Committee's session on
25 February 2000 and at other fora, i.e. the ASEM meeting on 1 March 2000 in Bangkok and the
OECD special meeting on technical barriers to trade on 16-17 March 2000 in Paris.  This draft of the
text of the International Model  was finalized in April 2000 and disseminated among delegations to
the UN/ECE Working Party 6.  Thus, the attached revised version supersedes the text contained in thedocument G/TBT/W/129.
Questions and comments on this provisional draft of the project may be referred to
Mr. Serguei Kouzmine, secretary to the UN/ECE Working Party on Technical Harmonization and
Standardization Policies, Palais des Nati ons, UN/ECE, office 433-1, CH-1211, Geneva 10;
tel.:  (41/22) 917 27.71, fax:  (41/22) 917 04.79/917 00.37;  e-mail-serguei.kouzmine@unece.org.G/TBT/W/129/Rev.1
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FIRST DRAFT
“AN INTERNATIONAL MODEL FOR IMPLEMENTING GOOD REGULATORY
PRACTICE FOR THE PREPARATION, ADOPTION AND APPLICATION
OF TECHNICAL REGULATIONS VIA THE USE
OF INTERNATIONAL STANDARDS”
Foreword
1. The Project reproduced below has been suggested and prepared by the UN/ECE ad  hoc team
of specialists on Standardization and Regulatory Techniques (“START”).
2. The START Team was established in September 1999.  It works under the auspices of the
UN/ECE Working Party on Technical Harmonization and Standardization Policies (WP.6) which, at
its ninth session in May 1999, decided to establish this team to examine the relationship between
international standardization and technical regulations.  The formation of the team has been confirmedby the UN/ECE Committee for Trade, Industry and Enterprise Development.
3. The proposed “International Model” entails overall exploration of good regulatory practices
to be used in the process of international technical harmonization.
4. When completed, the “International Model” will be a conceptual document with a set of
voluntary principles and procedures for sectoral application.  Countries that would like to harmonize
their technical regulations may wish to implement these principles and procedures.
5. The present draft was finalized by the START Team in April 2000. It takes into account
comments expressed during presentations of an outline of the  “Model” that were made to the session
of the WTO Committee on Technical Barriers to Trade (25 February 2000, Geneva), ASEM meeting
(1 March 2000, Bangkok) and to the OECD spec ial meeting on technical barriers to trade
(16-17March 2000, Paris).  The START Team will continue to work on the current draft which
foresees, for example, preparation of a number of annexes covering administrative and technical
procedures for implementation of the “International Model” and other issues.
6. A final draft of the “International Model” will be officially submitted for consideration and
discussion to the tenth session of the Working Party on Technical Harmonization and StandardizationPolicies (6-8 November 2000, Geneva).
7. This draft paper has not undergone formal editing.
I. INTRODUCTION
1. Discussions within different international organizations and fora show a clear desire to
harmonize technical regulations with a view to limiting obstacles to international trade and tofacilitating market access.  Some international technical regulations exist, but they tend to becumbersome and burdened with details.  They have also proven to be difficult to prepare.  As aconsequence such regulations, once in place, can be difficult to amend.  Detailed agreements betweena large number of regulatory authorities are frequently difficult to obtain, and such regulations tendnot to achieve full consensus.
2. A regulatory framework that comprises broad common regulatory objectives might be easier
to compile and might more easily find consensus.  For the detailed requirements that implementG/TBT/W/129/Rev.1
Page 3
common regulatory objectives recourse could be had to established mechanisms of International
Standardizing Bodies, which provide a forum for all interested parties (including regulatory
authorities), and have established a degree of trust at the international level.
3. These problems have been recognized by the UN/ECE Working Party on Technical
Harmonization and Standardization Policies (WP.6), which at its ninth session in May 1999commissioned a team of specialists to investigate the question.  This team was established under theacronym START (Standardization and Regulatory Techniques), and the UN/ECE Committee forTrade, Industry and Enterprise Development has confirmed its formation .  The work of the Team is
intended to provide guidance for good regulatory practice and a mechanism for co-operation betweenregulatory authorities, standardizers and industry, so that legislation can make appropriate use ofstandards.
4. There are major activities in this area, particularly under the WTO/TBT Agreement, and it is
appropriate to develop further the practical dimensions of the provisions inherent in that Agreementinto a general mechanism for the co-existence of harmonized technical regulations and internationalstandards.  Information for the development of the following proposed provisional “International
Model” is also derived from useful work in other international fora.  These include the WTO’s workin trade policy review, the OECD’s work in regu latory reform and international standards, and
APEC’s and ASEM’s work in creating guidelines on technical regulations.
5. It is, for example, assumed that whenever a new or revised technical regulation (TR;  for
abbreviations used, see Annex D) is being prepared, regulators should follow the principles set up in
the WTO/TBT Agreement (in particular, that TRs shou ld be based on relevant international standards,
when they exist or their completion is imminent, except when such standards would be ineffective orinappropriate for the technical regulation in questio n; that TRs should not be more trade-restrictive
then necessary and should be non-discriminatory).
6. The draft “International Model” provides practical steps aimed at facilitating and accelerating
the harmonization of technical regulations.
II. PROPOSAL FOR A MECHANISM AND PROCESS FOR THE HARMONIZATION
OF TECHNICAL REGULATIONS
7. The “International Model” addresses the steps to be followed when harmonization of
technical regulations is favoured by a number of countries.  The nature of such harmonization might
be limited to the definition of Common Regulatory Objectives (CROs) that are making recourse to
international standards (which would provide a possible means to fulfil or implement those
objectives).  It is proposed that the CROs could ei ther be linked to existing international standards or
that a call could be made for the development of new ones.
8. A distinction is necessary between the specifications applicable to products, as such, and the
conformity assessment requirements to be used to ensure that the products placed on the marketconform to the characteristics required.  The “Inter national Model” is intended to cover both these
issues.
III. IDENTIFICATION OF THE NEED FOR HARMONIZATION
9. The need for harmonization of TRs might be identified by one of the following “trigger”
mechanisms:G/TBT/W/129/Rev.1
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(a) By specialists from a particular sector/industry and raised in national, regional or
international;
(b) In studies specially commissioned by governments, international organizations,
business groups, non-governmental organizations (NGOs);
(c) Through initiatives by one or more particular countries to harmonize their TRs at an
international level;
(d) Through “complaint-based” initiatives when a country is responding to complaints
from foreign or national business operators concerning its TR regime;
(e) When it concerns new or revised TRs, the existing notification procedures under the
WTO/TBT Agreement requires proposed technical regulations/conformityassessment procedures to be systematically notified.  This might be regarded as a“trigger” mechanism to examine the need fo r a TR.  If this need is recognized by
other countries they might be willing to state their interest in having that TRinternationally harmonized.
10. A country interested in initiating the mechanism for harmonizing technical regulations should
address the United Nations (UN/ECE Commission) to launch a Call for Participation by other
members of the United Nations.  If such a Call were positively responded to by other membercountries of the United Nations, the countries concerned would co-operate in formulating CROs inaccordance with Good Regulatory Practice and through the UN established procedures (as describedin Annex A).
A. PROCESS OF HARMONIZING TECHNICAL REGULATIONS
11. The administrative procedure proposed for the preparation of CROs is set out in Annex A.
Based on the proposal for CROs, interested countries (effectively, any country that had responded
positively to a call for participation) should co-operate  in formulating such  CROs - to be in line with
recognized Good Regulatory Practice and in particular making recourse whenever appropriate tointernationally standards, either new or existing.
12. Upon completion of the text of the CROs, the c ountries would, with a view to having an open
and transparent process, announce to the United  Nations (UN/ECE Commission) their intention to
nationally implement them; other member countries of the United Nations would be invited to
implement them either immediately or in due time.  The UN would register the CROs and their
implementation in national technical regulations.
B. T
HE CALL FOR , PREPARATION AND IMPLEMENTATION OF INTERNATIONAL STANDARDS
13. Once the CROs are completed, the countries involved would request the UN to issue an
International Standardization Request, ISR (for m odel see Annex B) which would request the named
international standardization bodies to provide standards to meet the technical requirements of the
CROs (see Annex C of the elements to be included in  a CRO).  Upon proposal from the international
standardization bodies the countries concerned would examine the standards provided with regard to
the extent to which they meet the CROs.  If they do, such standards should be given the name“Internationally Recognized Standards” (I RSs) within the “International Model”.
14. It would appear that some kind of international group or panel of technical experts (Technical
Advisory Panel, TAP) may be required in order to assist interested countries in the preparation of theCROs, and in drafting of the ISR (with the view to  contributing to the formulation of the  CROs and
to the necessary coherence between the harmoni zed national technical regulations and betweenG/TBT/W/129/Rev.1
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different standardization requests to be made to different ISBs), to monitor the allocation of work
between different ISBs, and to provide advice on other associated technical matters.
15. Countries involved in the establishment of new  IRSs would commit themselves to using
them as a basis for the implementation of their national technical regulations.  When an IRS has beencompleted it should be registered within the United Nations (UN/ECE Commission) and thereby begiven a presumption of conformity with related CROs.
C. C
O-OPERATING IN THE PROCESS OF PREPARATION OF A CRO
16. It is assumed that countries participating in the preparation of a CRO would support the
technical work in the ISBs (for example, in the form of hosting a technical committee), would provideresources for the preparation of the corresponding IRSs, and that in general they would take aconstructive approach and would refrain from activities that would conflict with or jeopardise theinternational work in preparation.
D. P
LACING COMPLIANT PRODUCTS FOR FREE CIRCULATION ON THE MARKET OF COUNTRIES
WHICH HAVE AGREED ON A CRO
17. If the system of CROs is to be effective in opening trade, there would need to be mechanisms
to ensure that products falling within the scope of the CRO, that complied with its terms, and were
properly attested as doing so, could be placed on the market in the countries that have agreed on the
CRO.  Thus, each CRO would need to contain pr ovisions that compliance would have to be
determined, assured and demonstrated (through Supplier’s Declaration of Conformity, certification by
recognized Conformity Assessment Bodies etc.).
18. Countries that have agreed on a CRO would assure that products, which comply with the
CRO, could be placed on their market for free circulation without being subject to any furtherrequirements as to conformity assessment (e.g. testing or certification).
E. D
ETERMINING AND ASSURING CONFORMITY WITH A CRO
19. The CRO should contain requirements related to  how conformity with its terms is to be
assured and demonstrated.
(a) The preferred means of assuming compliance should be through Supplier’s
Declaration of Conformity (SDoC).
(b) However, in certain cases, particularly when safety and health are important, the
countries agreeing on a CRO may consider a more stringent conformity assuranceprocedure necessary.
20. In either case - either where the SDoC is considered sufficient, or where a more stringent
procedure is required, the procedures should be specified in the CRO.  If a third party assessment ispreferred, the CRO should state that compliance should be assessed and attested by a RecognizedConformity Assessment Body (RCAB).
F. R
ECOGNIZED CONFORMITY ASSESSMENT BODIES (RCAB S)
21. The technical competence of the CABs should be attested through accreditation by an official
accreditation body, recognized as such by the government of a member country of the United Nationsas competent for accreditation in the technological field defined by the scope of the CRO.  TheG/TBT/W/129/Rev.1
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countries, which have agreed on a CRO, should designate their CABs as recognized to perform
assessment and attestation under the CRO.  In  addition, for each CRO for which the CABs are
recognized, the countries that have agreed on the CRO should notify their CABs to the United Nations(UN/ECE Commission).  Such bodies should be listed in the CRO.
G. C
LAIM OF CONFORMITY WITH A CRO
22. Products within the scope of a CRO should carry some means (e.g. a declaration or a
certificate) demonstrating either that the supplier claims the conformity with the CRO or thatconformity has been assessed and attested by a RCAB.  In either case documented evidence should beprovided with the product.  The nature of such evidence should be specified in the CRO.
23. The nature of the statement of compliance will depend to an extent on the conformity
assessment regime prescribed in the CRO.  Within such constraints the statement of compliance mayconsist of accompanying documentation (such as a written SDoC or a certificate of conformity).  Allclaims of compliance must include the UN registration number for the applicable CRO.
H. M
ARKET SURVEILLANCE AND PROTECTION PROVISIONS
24. Countries that agree on CROs would remain responsible for market surveillance on their
territory.  If a country finds products claiming conformity with a CRO that do not actually conformwith its requirements, they may, with the intention to preserve public health and safety or otherlegitimate objectives, take action to withdraw such a product from their market.  However, use of thisclause should be subject to a condition that the country using it should state, to the United Nations(UN/ECE Commission), specifically  what products have been removed from the market and what
requirements of the CRO have been claimed to be met but have not been met.
25. If the supplier is from the same country as the country declaring the use of the protection
provisions, notification to the United Nations (UN/ECE Commission) is still requested, so that othercountries could take similar actions.  If the supplier is from a country different from the one declaringthe protection provision, the countries concerned should try to solve this issue between them.  Othercountries may associate themselves with such a process.  In any case such action should be declaredto the United Nations (UN/ECE Commission).
I. R
ESOLVING DISPUTES
26. In addition, use of the protection provisions may trigger a process in WTO when regarded as
“a technical regulation which may have a significant effect on trade of other (WTO) Members”(Art. 2.5 of the WTO/TBT Agreement).  If the matter goes to the WTO the United Nations(UN/ECE Commission) would take no further action.  If on the other hand no action has beentriggered in the WTO as a result that this matter has not been considered to fall under the provisionsof Art. 2.5 of the WTO/TBT Agreement or for other reasons (e.g., that the country declaring the useof the protection provisions is not a WTO Member), then the United Nations (UN/ECE Commission)should convene a dispute resolution panel (DRP).  The countries that agreed on the CRO should agreeto abide by the decision of such panel (perhaps with some kind of appeal mechanism).G/TBT/W/129/Rev.1
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LIST OF ANNEXES
ANNEX A
Administrative procedure for the call for participation in formulating Common Regulatory
Objectives (CROs) and the preparation of CROs
ANNEX B
Model for an International Standardization Request (ISR)
ANNEX C
Elements to be included in a Common Regulatory Objective (CRO)
ANNEX D
List of abbreviations used in the International ModelG/TBT/W/129/Rev.1
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ANNEX D
List of abbreviations used in the “International Model”
CAB Conformity Assessment Body
CRO Common Regulatory ObjectiveDRP Dispute Resolution PanelIRS Internationally Recognized Standard/SpecificationISB International Standardizing BodyISR International Standardization RequestRCAB Recognized Confor mity Assessment Body
SdoC Supplier’s Declaration of ConformityTAP Technical Advisory PanelTR Technical Regulation
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