RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/161
19 June 2001
(01-3054)
Committee on Technical Barriers to Trade Original:  English
UN/ECE PROJECT FOR AN INTERNATIONAL MODEL FOR TECHNICAL
HARMONIZATION:  A CONCEPT FOR REGULATORY CO-OPERATION
AND ITS RELATION TO THE TBT AGREEMENT
Communication from the United Nations Economic Commission for Europe
The following Communication has been received from the UN/ECE Working Party on
Technical Harmonization and Standardization Policies (Working Party 6) with the request that it be
circulated to the Committee as information on UN/ECE activities relating to technical harmonizationand good regulatory practice.
_______________
I. BACKGROUND
1. Regulators can deploy a number of means to prevent technical regulations from constituting
unnecessary barriers to trade.  The TBT agreement ex plicitly refers to using international standards as
a basis for technical regulations (cf. Art. 2.4 and cf. Art. 2.6), and to accepting as equivalent the
technical regulations of other Members (cf. Art. 2.7).  It also encourages the use of relevant
international guides or recommendations as a basis for conformity assessment procedures
(cf. Art. 5.4), and the conclusion of agreements for the mutual recognition of the results from eachother’s conformity assessment procedures (cf. Art. 6.3).
2. At the First Triennial Review, the Committee reit erated that good regulatory practice for the
preparation, adoption and application of technical regulations was a priority for Members to facilitate
trade, and the Committee agreed at the Second Trienn ial Review to continue an information exchange
in this regard while noting that minimizing the use of mandatory technical regulations and usingvoluntary international standards, where appropriate, could reduce the regulatory burden and open up
market access opportunities.  The Committee also agreed on this occasion that regular information
exchange between the Committee and other relevant bodies would be useful.
II. SCOPE
3. The UN/ECE Working the Party on Technical Harmonization and Standardization Policies
(WP.6) has provided for more than 30 years an interface between the regulatory and the
standardization community, for instance, by keeping a standardization list by which regulators can
flag areas where they would deem it would be useful for voluntary standards to be developed,
possibly for subsequent use in relation with technical regulations.  The United Nations Economic
Commission for Europe, under which Working Party 6 operates, also has a longstanding record of
offering member countries a platform for the harmonization of national technical regulations such as
is done in the area of motor vehicles (UN/ECE Working Party 29-World Forum for Harmonization of
Vehicle Regulations).G/TBT/W/161
Page 2
4. However, international technical harmonization could be even further advanced by reducing
the regulatory burden and using international standards where appropriate.  For this purpose, in 1999,
Working Party 6 established an ad hoc team of specialists on Standardization and Regulatory
Techniques (the "START" Team).
5. The Committee has been informed already about “START” team activities through
documents G/TBT/W/129 of 22 March 2000 and G/TBT/W/129/rev.1 of 11 May 2000.
6. The attached document reproduces the latest text for “an international model for technical
harmonization based on good regulatory practice for the preparation, adoption and application of
technical regulations via the use of international standards” as prepared by the Team at its May 2001
meeting.
7. For more information on the activities of the UN/ECE Working the Party on Technical
Harmonization and Standardization Policies (WP.6) the following web site can be consulted:http://www.unece.org/trade/stdpol .
__________G/TBT/W/161
Page 3
Document attached to G/TBT/W/…
UNITED NATIONS ECONOMIC COMISSION FOR EUROPE (UN/ECE)
COMMITTEE FOR TRADE, INDUSTRY AND
ENTERPRISE DEVELOPMENT
Working Party on Technical Harmonization  Revision of 11 May
2001
and Standardization Policies (WP.6)
Ad hoc Team of Specialists on Standardization
And Regulatory Techniques ("START" Team)
DRAFT PROPOSAL FOR
“AN INTERNATIONAL MODEL FOR TECHNICAL HARMONISATION BASED
ON GOOD REGULATORY PRACTICE FOR THE PREPARATION, ADOPTION
AND APPLICATION OF TECHNICAL REGULATIONS VIA THE USE OF
INTERNATIONAL STANDARDS"
This draft paper contains a proposal for an "International Model", which was edited by the ad
hoc Team of Specialists on Standardization And Regulatory Techniques ("START" Team) at its
meeting in May 2001.
It is recalled that the first draft of th e "International Model" can be found in UN/ECE
document TRADE/WP.6/2000/8.
The present document is reproduced in the form and language in which it was received by the
secretariat.G/TBT/W/161
Page 4
FOREWORD
/g216 The proposal reproduced below has been suggested and prepared by the UN/ECE ad  hoc team of
specialists on Standardization A nd R egulatory T echniques (“START”).
/g216 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 confirmed
by the UN/ECE Committee for Trade, Industry and Enterprise Development.
/g216 The “International Model” recognises that a framework for ensuring that technical regulations and
standards do not create barriers to trade exists  in the WTO Agreement on TBT. The Model adds to
this framework by suggesting solutions for the practical implementation of technical harmonization
and draws from existing schemes for good regulatory practice to be used in the process of
international technical harmonization.
/g216 The proposal constitutes a model with a set of voluntary principles and procedures for sectoral
application.  Countries that would like to harmonize their technical regulations may wish to
implement the principles and procedures as suggested by the “Model”.  To this end the details of
procedures for such application will have to be elaborated by the interested countries.
/g216 This proposal was edited by the “START” Team in May 2001. It takes into account the comments
expressed during presentations of the “Model” that were made to the session of the WTO Committee
on Technical Barriers to Trade (25 February and 19 May 2000, Geneva), ASEM meeting (1 March
2000, Bangkok) and the OECD special meeting on technical barriers to trade (16-17 March 2000,
Paris).  The UN/ECE has also convened an informal expert meeting (7 June 2000, Geneva) to explore
the benefits of the “Model” when applied in different sectors/product areas.
/g216 The first draft of the “International Model” was presented to the WP.6 session in November 2000
which supported activities of the “START” Team, the draft model  and asked for new nominations to
the Team.
/g216 The annex for administrative and institutional provisions (annex C) is currently under preparation.
/g216 This proposal has not undergone formal editing.
INTRODUCTION
1. Discussions within different international organizations and fora show a clear desire for the
convergence of technical regulations with a view to limiting obstacles to international trade and to
facilitating market access.  Some international technical regulations exist, but they tend to be
cumbersome 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 between
a large number of regulatory authorities are frequently difficult to obtain, and such regulations tend
not to achieve full consensus.
2. A regulatory framework comprising broad common regulatory objectives might be easier to
compile and might more easily find consensus.  For the detailed requirements that implement
common regulatory objectives recourse could be made to established mechanisms of InternationalG/TBT/W/161
Page 5
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 1999
commissioned a team of specialists to investigate the question.  This team was established under theacronym “START” (Standardization A
nd R egulatory T echniques), and the UN/ECE Committee for
Trade, 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 between
regulatory authorities, standardizers and industry, so that legislation can make appropriate use of
standards.
4. There are major efforts regarding the elimination of technical barriers to trade, particularly
under the WTO/TBT Agreement, and it is appropriate to develop further the practical dimensions of
procedures that are complementary to and coherent with the TBT Agreement.  This could be done by
way of a general mechanism for linking harmonized technical regulations and international standards.
Information used in the development of the following proposed, provisional “International Model”
was also derived from useful work undertaken in other international fora.  These include the WTO’swork on trade policy review, the OECD’s work on re gulatory reform and international standards, and
Asia-Pacific Economic Cooperation's (APEC) an d the Asia-Europe Meeting's (ASEM) work on
creating guidelines on good regulatory practice.
5. It is, for example, assumed that whenever a new or revised technical regulation (TR; for
abbreviations used, see Annex A) is being prepared, regulators should follow the principles found in
the WTO/TBT Agreement.  In particular, it is assumed that TRs should be based on relevant
international standards, when they exist or their completion is imminent, except when such standards
would be ineffective or inappropriate for the techni cal regulation in question; that TRs should not be
more trade-restrictive then necessary and that they should be non-discriminatory.
6. Where harmonization is deemed useful by interested countries, the draft “International
Model” provides practical steps aimed at facilitating and accelerating the harmonization of technical
regulations by agreeing on  Common Regulatory Objectives (CROs). for applicable products or
product areas (sectors).
PROPOSAL FOR A MODEL FOR THE HARMONIZATION OF TECHNICAL REGULATIONS
AND FREE CIRCULATION OF COMPLIANT PRODUCTS
Basic elements for harmonization and free circulation
7. The “International Model” addresses the steps to be followed when harmonization of
technical regulations is favoured by a number of UN member countries.  The nature of suchharmonization should preferably be limited to agreeing on Common Regulatory Objectives (CROs)
Such objectives will address legitimate concerns of governments, for instance, those related to public
health, safety or the protection of the environment. The format and possible elements to be included in
a CRO are set out in Annex B.  The CROs would be transposed into technical regulations at national
level by those countries who agreed on them.  The mechanism for national transposition of CROs is to
be defined by individual UN member countries according to their national legal practice. For
demonstration of compliance with CROs a possible means could be recourse to relevant international
standards.G/TBT/W/161
Page 6
8. A distinction should be made between the specifications applicable to products, as such, and
the conformity assessment requirements to be used to ensure that the products placed on the market
conform to the characteristics required.  The CROs shall cover these issues.
9. If the system of CROs is to be effective in facilitating 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.
10. Countries that have agreed on a CRO would a ssure that products, which comply with the
CRO, could be placed on their market for free circulation without being subject to any additional
product or conformity assessment requirements (e.g. testing or certification).  If a country imposes
additional requirements despite having agreed on a CRO it shall inform the other countries (throughthe United Nations (UN/ECE Commission)) of thes e measures.  The other countries would under such
circumstances be free to take appropriate measures and ultimately restrict the free circulation on their
markets of relevant products from the country that has approved additional requirements.
Identification of the need for harmonization
11. The responsibility for technical regulations and their harmonization  lies with national
regulatory authorities. The need for harmonization might, amongst others, be identified by one of the
following ”trigger” mechanisms:
• By specialists from a particular sector/industry and raised in national, regional or international
fora In studies specially commissioned by governments, international organizations,business groups, non-governmental organizations (NGOs);
• Through initiatives by one or more particular countries to harmonize their TRs at an
international level;
• Through ”complaint-based” initiatives when a country is responding to complaints from
foreign or national business operators concerning its TR regime;
When it concerns new or revised TRs, the existing notification procedures under the WTO/TBT
Agreement requires that proposed technical regulations/conformity assessment procedures to be
systematically notified. This might also be regard ed as a “trigger” mechanism for examining the need
for a TR.  If this need is recognized by other countr ies, they might be willing to state their interest in
having the proposed TR internationally harmonized.
Process of establishing a CRO
12. An UN member country interested in using  the mechanism of this “International Model” for
harmonizing technical regulations through establishing CROs could address the United Nations
(UN/ECE Commission) to launch a Call for Participation by other member countries of the United
Nations (see Annex C).  The purpose of such a Call would be to explore the interest for internationalharmonization via agreed upon CROS for the products or product areas in question.  If such a Call
were positively responded to by other member countries of the United Nations, the countries
concerned would co-operate in formulating CROs.
13. The procedure proposed for the preparation or revision of CROs and legal formats for their
approval is  set out in Annex C. Based on the proposal for CROs, interested countries, effectively, any
country that had responded positively to a Call for Participation shall co-operate in formulating CROs.
During the preparation of CROs by the group of interested countries any other UN member country
could join this group or participate in the work an observer.G/TBT/W/161
Page 7
14. Upon completion of the text of the CROs, the UN member countries having agreed on them
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 in national technical regulations.
Other member countries of the United Nations would be invited, on a voluntary basis, to implement
them either immediately or in due time. The UN would register the CROs and their implementation innational technical regulations. Such information would be made publicly accessible.
15. In parallel to the preparation of CROs, countries should explore the existence of relevant
international standards to be considered for re ference in formulating CROs. In case no relevant
standards exist, countries may consult with relevant  international standardizing bodies (ISBs), through
their official representatives, regarding the initiation of new standards work to support specific CRO
provisions. It is assumed that countries collaborating on a CRO would support related standards
development activities, within the limits of their av ailable resources.  It is also expected that they
would refrain from activities that would conflict with or jeopardize this standardization work in
preparation.
16. When the relevant international standards ar e available from international standardizing
bodies they should be referred to in the CRO and the conditions for their use should be specified in
the CRO.
Determining and assuring conformity with a CRO
17. The CRO should contain requirements related to  how conformity with its terms is to be
assured and demonstrated.  Whenever appropriate, the means of assuming compliance should be a
Supplier’s Declaration of Conformity (SDoC).  However, in other cases, particularly when safety andhealth concerns are important, the UN member count ries agreeing on a CRO may find it necessary to
make recourse to more stringent conformity assurance procedures.  In either case - where the SDoC is
considered sufficient, or where a more stringent procedure is required, the procedures should be
specified in the CRO.  If third party assessmen t is deemed necessary, the CRO should state that
compliance be assessed and attested by Recogn ised Conformity Assessment Bodies (RCABs).
Recognised Conformity Assessment Bodies (RCABs)
18. The requirements with regard to the technical competence of the Conformity Assessment
Bodies (CABs) in the field defined by the CRO should be set out as an integral part of the CRO.   The
countries, which have agreed on the CRO, could designate CABs as recognized to perform
assessment and attestation under the CRO. A list of such recognized bodies (RCABs) should be madepublically available for instance by annexing it to the CRO and such bodies should be registered by
the United Nations (UN/ECE Commission).
Claim of conformity with a CRO by the supplier
19. Products covered by the scope of a CRO w ould carry some means (e.g. a SDoC or a
certificate of conformity) demonstrating either that the supplier claims conformity with the CRO or
that conformity has been assessed and attested to by a RCAB.  In either case, documented evidence
should be provided with the product.  The type of su ch evidence should be specified in the CRO.  All
claims of compliance must include the reference to applicable CRO, for example, the registration
number allocated by the United Nations ( UN/ECE Commission) for the applicable CRO.G/TBT/W/161
Page 8
Market surveillance and protection clause
20. Countries having agreed on CROs are responsible for market surveillance on their territory
and have the right to withdraw products from their national markets if not in compliance with the
CRO.
21. In case a product is in conformance with a CRO but is found to endanger health and safety or
other legitimate objectives a country can take necessary steps to withdraw such a product from the
market or restrict its free circulation by evoking the protection clause of a CRO (for details see
Annex B).
22. Countries should report such actions both relating to domestic and foreign products to the
United Nations (UN/ECE Commission) and in dicate the reasons for this decision.
*  *  *  *  *  *G/TBT/W/161
Page 9
LIST OF ANNEXES
ANNEX A
List of abbreviations used in the International Model
ANNEX B
Format and possible elements to be included in a CRO
ANNEX C
(under preparation)
Administrative Procedures and Institutional ProvisionsG/TBT/W/161
Page 10
ANNEX A
List of abbreviations used in the “International Model”
CAB Conformity Assessment Body
CRO Common Regulatory ObjectiveISB International Standardizing BodyPC Protection ClauseRCAB Recognised Conformity Assessment BodySDoC Supplier’s Declaration of ConformityTR Technical RegulationG/TBT/W/161
Page 11
ANNEX B
Format and possible elements to be included in a CRO
A CRO is a mutually agreed document registered by the United Nations (UN/ECE Commission) and
publicly available. By establishing such a document the interested countries agree on elements suchas:
Scope statement
A statement of the products or product areas that are covered by the CRO.Countries should agree on the products for which legitimate regulatory objectives are required.  For
this purpose countries may use international classification schemes such as the harmonizedcommodity description and coding system.
Product requirements
Legitimate regulatory objectives reflect the requirements of governments to protect public interest in
areas such as human health or safety, animal or  plant life or health or the environment. The
requirements needed for protection of legitimate objectives should lay down the principle issues ofconcern and be specified in terms of performance requirements rather than design or descriptivecharacteristics. Requirements should be limited to relevant aspects and be proportionate to the hazardinherent to a given product or product areas.
The detailed provisions on how to meet the requirem ents of the CRO should preferably  be specified
in international standards..  Such sta ndards will be referenced in the CRO.
Reference to standards clause
The CRO should contain a list of applicable international standards which correspond as a whole or
partially to the requirements.
The CRO may contain a provision that products complying with the referenced international standards
are presumed to comply with the requirements.
Compliance clause
The CRO should contain a provision on how compliance is demonstrated.Countries  should agree on the range and contents of possible conformity assessment procedures
which are considered to give the necessary level of protection under the CRO. The CRO should alsospecify the conditions under which suppliers can make a choice if more than one option is providedfor.  Such options are, for instance, supplier’s declaration of conformity, third party certification orinspection.
When applicable, the CRO should also contain provisions on the conformity assessment bodies which
are recognised  to assess and attest compliance as well as the competence criteria to be fulfilled bysuch bodies.G/TBT/W/161
Page 12
Market surveillance and Protection clause
Countries having agreed on CROs are responsible for market surveillance on their territory and have
the right to withdraw products from their national markets if not in compliance with the CRO.
The CRO should contain a provision (protection cl ause) that if a country finds products claiming
conformity with a CRO that do not actually conform with its requirements, the country may, with the
intention to preserve legitimate objectives, withdraw  such a product from its market.  Furthermore, the
CRO should contain a provision that the country us ing the Protection Clause 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.
In a case where products are in conformance with the CRO or the applicable international standards
but are still found to endanger legitimate objectives, a country having agreed on a CRO could
withdraw such products from the market or restrict  free circulation. In this case, the use of the
Protection Clause should also be subject to the condition that the country using it should declare its
use to the United Nations (UN/ECE Commission) and indicate the reasons for this decision.
_______________