RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/173/Add.1
19 April 2002
(02-2203)
Committee on Technical Barriers to Trade Original:  English
A POLICY FRAMEWORK FOR THE FACILITATION OF TRADE IN THE FIELDS OF
STANDARDIZATION AND CONFORMITY ASSESSMENT:
A TOOLBOX OF INSTRUMENTS
Communication from the European Commission
Addendum
As requested by the European Commission, a copy of the document as mentioned in
G/TBT/W/173 is attached.G/TBT/W/173/Add.1
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WORKING DOCUMENT OF THE SERVICES OF THE COMMISSION
IMPLEMENTING POLICY FOR EXTERNAL TRADE IN THE FIELDS OF
STANDARDS AND CONFORMITY ASSESSMENT:
A TOOL BOX OF INSTRUMENTS
TABLE OF CONTENTS
I. SUMMARY ...................................................................................................................... .........3
II. INTRO DUCTION ................................................................................................................ ....4
III. SCOPE ...................................................................................................................... .................4
IV. BACKGROUND: POLICY OBJECTIVES AND CURRENT ACTIVITIES OF
THE COMM UNITY.................................................................................................................4
V. THE MECHANISMS OF TECHNICAL REGULATION AND THEIR
RELATIONSHIP WITH T RADE...........................................................................................6
VI. CONDITIONS FO R OPEN TRADE ......................................................................................6
VII. WORKING TOWARDS THE IDEAL:  A DIVERSITY OF  MEASURES .........................8
VIII. REGULATORY CO-OPERATION .......................................................................................9
PRACTICAL MEASURES IN REGULATORY CO -OPERATION ..............................................................10
IX. HARMONIZATION............................................................................................................... 11
X. RECOGNITION OF  EQUIVAL ENCE................................................................................11
XI. MUTUAL RECOGNIT ION AGREEM ENTS .....................................................................13
MULTILATERAL MUTUAL RECOGNITION ARRANGEMENTS .............................................................14
XII. PARTIAL, VOLUNTARY, REDUCED OR LESS FORMAL TYPES OF
MUTUAL RECOGNITION ..................................................................................................15
ACCREDITATION .........................................................................................................................16
CASE STUDIES :  EXAMPLES OF ACCREDITATION ACTIVITIES ........................................................17
CO-OPERATION ON THE DEVELOP MENT OF STANDARDS ..............................................................17
XIII. INTERNATIONAL STANDARDIZA TION........................................................................18
XIV. TECHNICAL ASSIST ANCE ................................................................................................19
THE AIMS OF TECHNICAL ASSISTANCE .........................................................................................19
TYPES OF TECHNICAL ASSISTANCE ..............................................................................................20
DELIVERING TECHNICAL ASSISTANCE ..........................................................................................20
CASE STUDIES : SOME EU TECHNICAL ASSISTANCE PROJECTS ......................................................20
XV. IMPLEMENTING  SYSTEMS ..............................................................................................21
XVI. CONCLUSION:  SELECTING THE RIGH T INSTRUM ENT .........................................22
PARTICULAR CHARACTERISTICS OF THE PARTNERS TO AN AGREEMENT ........................................22
AN APPROACH TO IDENTIFYING THE TOOL TO USE ......................................................................22G/TBT/W/173/Add.1
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WORKING DOCUMENT OF THE SERVICES OF THE COMMISSION
IMPLEMENTING POLICY FOR EXTERNAL TRADE IN THE FIELDS OF
STANDARDS AND CONFORMITY ASSESSMENT:
A TOOL BOX OF INSTRUMENTS
I. SUMMARY
1. All governments make regulations.  When such re gulations relate to things that are traded,
there will be an effect on trade with other countries, since foreign suppliers will need to comply with
the importing country’s rules.  Consequently, there have been substantial efforts to reduce the impact
on trade of national or regional regulation.  Regulations may serve legitimate ends, but at the sametime efforts are necessary to ensure that regulation should not be more trade-restrictive than necessary
to achieve such ends.  The application of the princi ple of proportionality ought to ensure the necessity
and effectiveness of the measures undertaken in comparison to the objective pursued.
2. The experience of the Commission in trade facili tation has led to the view that a broad variety
of measures can be applied to accomplish it.  Conditions for open trade include compatibility ofapproach, coherence of regulations and standards, transparency of rules, appropriate levels and means
of regulation, impartiality in certification, compatibility of market surveillance measures and
supervision practices, and an appropriate level of technical and administrative infrastructure.
3. Different measures are available to the Community and its trading partners to bring these
ideal conditions closer.  Measures such as regulatory co-operation (to make regulatory and market
surveillance systems more compatible); harmonization (to create single technical rules);  mutual
recognition agreements (to eliminate costs arising from unnecessary duplication of certificationrequirements);  support for the development of international standards (to create compatibility and
interoperability of products and, eventually, to provide a common technical basis for rules);  and the
development of codes of conduct and technical assi stance (to provide support for the setting-up of a
quality infrastructure in third countries), are all actions that can be used effectively to facilitate trade.
4. The Community should work towards achieving an optimal mix among these measures.  This
paper examines them in some depth, together with examples where appropriate, in order to facilitate
future choices.G/TBT/W/173/Add.1
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II. INTRODUCTION
5. There has in recent years been a renewed interest in international co-operation in the areas of
standards, conformity assessment, and the elimination of technical barriers to trade (TBT).
6. The purpose of this paper is to examine questions concerning technical rules and requirements
for products, and their effect on trade.  The effectiveness of measures for rendering rules less trade-restrictive, while pursuing legitimate regulatory objectives such as the protection of health and safety,
consumer protection and information, and protection of the environment, will also be considered.  The
analysis is intended to facilitate the identification and development of priorities for action in the field,
in such a way as to be as effective and cost-efficient as possible.
7. With the increasing recognition of the impact of technical rules on trade in goods, a number
of mechanisms to lessen this impact have been identified.  They could be further exploited in order to
offer a variable response, adapted to the needs and opportunities that present themselves in eachspecific situation.  The choice of instrument will depend on the characteristics of the markets, the
regulatory environment and technical infrastructure in the countries or regions concerned, the nature
of the products, and the willingness on the part of industries and regulators to make use of such
different instruments.
III. SCOPE
8. What follows is intended to deal with issues of external trade in industrial products.
However, the issues raised here may have implications for trade in other areas – for example, services,
and agricultural products – since the issues are often similar, even though existing regulatory
modalities are generally different.
9. In other words, the concepts developed here may be useful in other areas, on the
understanding that their application, if any, to those areas would depend on the specific regulatory
framework in each case.
IV. BACKGROUND: POLICY OBJECTIVES AND CURRENT ACTIVITIES OF THE
COMMUNITY
10. The Community's trade objectives can easily be summarised: first, to reduce technical barriers
in external markets and to prevent the emergence of new ones; and second, to encourage our trading
partners to adopt standards and regulatory approaches based on, or compatible with international and
European practice.  Achievement of both objectives will mutually facilitate trade and market access .
11. The general principles of EC external trade policy in this area are set out in the
1996 Communication from the Commission on the Community External Trade Policy in the fields of
Standards and Conformity Assessment1 The Communication rests on two assumptions:
                                                     
1COM(96) 564 final of 13.11.1996.G/TBT/W/173/Add.1
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(a) that the impact on trade of product standa rds and means of determining conformity with
them appears to be increasing, thereby giving rise to technical barriers to trade, and
demanding greater attention and action than in the past; and
(b) that the completion of the single market has placed the Community in a position to pursue a
more outward-looking trade policy in this field.
12. At the same time, other developments in the Community’s legal framework have propelled
the EU towards improving the effectiveness of regulatory authorities in protecting an ever-increasing
number of public policy interests such as health and safety, the environment, and consumers’
interests.  In this respect, it is worth mentioning the application of the principle of proportionality and
the recent Commission Communication on the precautionary principle2, where the Commission
considers that the principle has a scope to cover measures for protection of human, animal and plant
health in addition to environmental aspects.
13. The internal market itself has developed from a largely trade facilitation mechanism to one
that marries trade facilitation with a high level of protection of public interests, as defined in the
EC Treaty.  The policy towards standards and conformity assessment in external trade set out in the
Communication was endorsed by the Council3, which has also reaffirmed other aspects of this policy,
for example, the importance of coherence in international standards, and the creation ofstandards-receptive regulatory models
4.
14. The trade objectives have so far been purs ued through a four-fold strategy, comprising:
(a) Reliance on the WTO, notably the Agreement on Technical Barriers to Trade;
(b) Conclusion of bilateral (inter-governmental) agreements  to reduce barriers and the cost of
trade, which have so far consisted in the conclusion of Mutual Recognition Agreements
(MRAs) for conformity assessment, certificates and marking, which are intended to reduce
the costs of testing and certification in other markets, notably those of major trading
partners;
(c) Technical assistance to ensure that other countries’ regulatory regimes are transparent and
trade-friendly, and that an appropriate infrastructure in the areas of testing and certification
is being put into place;
(d) Regulatory co-operation, aiming at harmonising regulations with trading partners, achieving
a common understanding of “best regulatory practice” (BRP), and promoting recourse to it,
including increased transparency in regulations  and standards, international standardization,
and the harmonization of regulations amongst trading partners.
                                                     
2COM (2000) 01 final of 02/02/2000
3Council conclusions of 26 June 1997, OJ C8 of 11.1.2001, p.1-3
4Council resolution of 28 October 1999, OJ C141 of 19.5.2000, p. 1-4G/TBT/W/173/Add.1
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V. THE MECHANISMS OF TECHNICAL REGULATION AND THEIR
RELATIONSHIP WITH TRADE
15. The main elements that govern the placing on the market of goods can be identified for the
purposes of this paper, as:
(a) Technical regulations (laws) applying to the characteristics of products;
(b) Standards (drawn up by consensus), whether for voluntary application or incorporated into
the legal framework in some way or other;
(c) Certification requirements, determining how compliance with regulations is to be
determined, including marking and similar procedures;
(d) Testing procedures for the actual determination of compliance, and related aspects, such as
good laboratory practice, laboratory accreditation, and metrology;
(e) Market surveillance (including, where appropriate, product liability aspects).
16. Governments prescribe technical rules that apply to products; for a variety of reasons, such
rules may relate to the characteristics of the products, and may also make provision for the
certification that the product in fact complies with those technical rules.  Of course, rules are adopted
for legitimate purposes: the protection of safety and health, the environment, and so on; but they can
also be misused as means of erecting protective barriers around the domestic market.  For this reasonthe WTO TBT Agreement calls for technical rules and certification procedures not to be more
trade-restrictive than is necessary for the objective being pursued, to be transparent and
non-discriminatory, and for the use, where appropriate, of international standards.  There remains,
however, a need for further progress in its practical implementation.
VI. CONDITIONS FOR OPEN TRADE
17. A fully-developed common market between two or more territories will have the
characteristics that any product lawfully placed on the market in one territory will be equally freely
marketed in the other, and conversely, that products that may not be lawfully placed on the market in
one territory may not be so placed in the other.  The obvious example is provided by the EU internal
market.  The recommendations of the TBT Agreemen t go some way towards achieving the situation
described above.  It must be borne in mind, however, that the concepts contained in the
TBT Agreement cannot approach the situation of a common market, in the absence of a strong
institutional framework to support it, that is, of legislative and administrative bodies such as the
Council, the Parliament and the Commission, and judi cial control such as that exercised by the
European Court of Justice.
18. With this in mind, the most desirable situation, compatible with the provisions of the
TBT Agreement, would imply the following.
A. C
OMPATIBILITY OF APPROACH
19. Approaches to product regulation should be compatible, if not identical, at least within
defined product sectors.  Where sophisticated systems of product regulation have emerged, there may
be imbalances with less sophisticated systems (for example, with developing countries).G/TBT/W/173/Add.1
Page 7
B. COHERENCE OF REGULATION
20. Technical requirements (regulations) for specific products should be the same, or recognised
as equivalent for the purpose of fulfilling the same regulatory objectives.
C. COHERENCE OF STANDARDS
21. Standards, where they have either a regulatory impact or a major market impact, should be the
same, or technically equivalent, or at least be recognised as fulfilling the same technical objectives not
conflicting with each other.
22. This should perhaps be explained: standards, strictu sensu , are voluntary-compliance
documents, drawn up in principle by a consensus of those who will use them, to reach technical
objectives such as reducing unnecessary variety and providing known means of specification and
levels of performance.  Sometimes, as with the EU’s New Approach and public procurementlegislation, reference is made to them in laws; in many other cases, although entirely voluntary,
standards in effect have some prescriptive force because they provide a fundamental reference for
market participants.
D. T
RANSPARENCY AND IMPARTIALITY OF REGULATION AND STANDARDS
23. Both standards and technical regulations should be transparent and available to those who will
use them, be based on recognised international work wherever appropriate, and not be such as to
favour the products of one party over those of another.
E. APPROPRIATE LEVEL OF REGULATION
24. Technical regulations, and standards with regulatory or quasi-regulatory force, should be only
as stringent as is necessary for the achievement of legitimate public policy aims (such as those set out
in Art. 95 (3) of the EC Treaty for a high level of protection of health, safety, environmental
protection and consumer protection), taking account of new scientific developments.  The
TBT Agreement provides that regulations and standards shall not be more trade-restrictive thannecessary to fill a legitimate objective.
F. T
RANSPARENCY AND IMPARTIALITY IN OBTAINING CERTIFICATION
25. Certificates, where required, must be available by procedures that are the same whatever the
nature and nationality of the entity seeking them.
G. RECOGNITION OF CERTIFICATES
26. Certificates, where required, must be recognised by all authorities impartially as giving access
to the market.  As a consequence of this, there must be transparency as to the nature of the bodies
issuing the certificates and guarantees as to the quality of certificates.  Where appropriate (for
example, when certificates are granted by independent certification and assessment bodies rather than
directly by public authorities), there will be a requirement for agreement on accreditation or otherassessment of certification bodies, and on relevant metrology requirements.
H. C
OMPATIBILITY OF MARKET SURVEILLANCE
27. Market surveillance procedures - both before and after sale - must work in practice.  That is,
they should be effective, compatible and impartial, and not favour the products of one entity overthose of another.G/TBT/W/173/Add.1
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I. DEVELOPMENT OF INFRASTRUCTURE
28. A country must have the capacity and infrastructure necessary to make the relevant systems
work, including the capacity for regulation.  The necessary certification bodies, standards bodies,
laboratories and other facilities must exist and be sufficiently effective.
29. Imbalances between developed and developing economies may result in barriers to trade, for
example where producers in developing economies cannot meet other countries’ more sophisticated
product regulations, or where developing countries’ governments must rely on ex ante rules for
market access because they do not possess sufficient resources for effective ex post  market
surveillance.  It will be difficult for developing countries to participate in this kind of co-operative
trade facilitation measure until they have reached an adequate level of regulatory sophistication.  The
roles of technical assistance and capacity-bu ilding initiatives are important in this area.
VII. WORKING TOWARDS THE IDEAL: A DIVERSITY OF MEASURES
30. The 1996 Commission Communication on Community external trade policy in the field of
standards and conformity assessment , already mentioned above, formulates two “basic objectives”, as
follows
“First, to reduce or prevent the emergence of new standards and conformity assessment
barriers for industrial products in other markets.  Secondly, to promote where possible, the
adoption overseas of standards and regulatory approaches based on, or compatible with,
international and European practices, in order to improve the market access and
competitiveness of European products.”
31. Sometimes the adoption of Community practice is complete.  For example, the countries of
the European Economic Area (EEA) have adopted all the acquis communautaire  as it relates to the
trade in goods.  Countries that are candidates for accession to the EU have also committed themselves
to adopting all the elements of the European sy stem (since their intention is to become Member
States, this will be necessary at the time of their accession in any case).
32. For other countries though, it may not be commercially profitable, or politically desirable or
practical, to achieve such complete alignment in all the areas of the acquis .  Other instruments are
being explored by the Community and by other countries, such as mutual recognition agreements
(MRAs).  However, it has become increasingly clear that MRAs represent only one of a series of
instruments, and that all trade facilitation inst ruments have implications for their practical
implementation that need careful consideration.
33. Some tools for addressing each of the issues indicated above can be identified: for Nos.1, 5
and 8, regulatory co-operation; for No.2, harmonization of regulation, international regulation, and
recognition of equivalence; for Nos. 3 and 4, harmonization of standards, international standardization
and recognition of equivalence; for Nos. 6 and 7, mutual recognition agreements, and for Nos. 8 and
9, technical assistance programmes (See Table 1 for a summary).
34. These elements are not, of course, entirely separate, and for that reason the correlations set
out in Table 1 should be regarded as merely indicative.  For example, harmonization and regulatory
co-operation are closely linked, and international standardization has strong links both with regulation
and with certification.  The choice of measures will need to take coherence into account, together with
other factors such as the level of trade between th e parties and the technical infrastructure in those
countries.  It should also be remarked that all these instruments can be applied bilaterally, regionally
or multilaterally.G/TBT/W/173/Add.1
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Table 1.
An indicative list of tools for addressing regulatory issues
This table is intended to suggest measures that might be appropriate in each case; it is not exhaustive
and the correlations set out are not mutually exclusive.
No. Issues Some tools for addressing them
1. Compatibility of approach Regulatory co-operation
2. Coherence of regulation Harmonization of regulation
International regulation
Recognition of equivalence
3. Coherence of standards Harmonization of standards
International standardizationRecognition of equivalence
4. Transparency and impartiality of
regulations and standardsHarmonization
International regulation and
standardization
Recognition of equivalence
5. Appropriate level of regulation Regulatory co-operation
6. Transparency and impartiality in
obtaining certificationMutual recognition agreements
Technical assistance
7. Recognition of certificates Mutual recognition agreements
8. Compatibility of market
surveillanceRegulatory co-operation
Technical assistance
9. Development of infrastructure Technical assistance
VIII.  REGULATORY CO-OPERATION5
35. As has already been indicated, regulations, standards and conformity assessment procedures
serve legitimate objectives, such as protection of safety and health, the environment, the promotion of
quality, the control of unnecessary diversity in products, and the protection of consumers from
deceptive marketing.  On the other hand, they have a very substantial potential to impede trade.  One
purpose of regulatory co-operation is to reconcile these aims.  Thus the objective quoted above, “to
reduce or prevent the emergence of new standards”, should be understood as being applicable where
such standards constitute unnecessary6 obstacles to trade.
                                                     
5In line with the Commission Communication, this encompasses both multilateral initiatives for
harmonising regulatory requirements and mandatory standards and for developing best practice in conformityassessment, and bilateral co-operation with the EU’s trading partners in developing technical regulations,harmonising standards and regulatory reform
6It is assumed that the trade impact of regulation that is necessary to achieve the objectives of the
regulation is proportional, and is compatible with the TBT Agreement (Art.2.2: “...technical regulations shall
not be more trade-restrictive than is necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create.”).G/TBT/W/173/Add.1
Page 10
36. The co-operative mechanisms that emerge will inevitably differ in the light of the nature of
the products, historical factors (the previously existing structure of regulation), the compatibility of
regulatory systems, and the extent of the will to open trade.
37. Regulatory co-operation is typically an informal process during which regulators consult with
each other during various stages of the regulatory process.  Such co-operation can be based onbilateral, regional or multilateral arrangements, and is often encouraged by industry willing to see
governments agree on common solutions.
38. The major instrument already achieved in this area is, of course, the WTO TBT Agreement.
In prescribing notification of proposals for technical regulations and standards programmes, and
calling upon its signatories and their standards bodies to base technical rules, standards and
certification requirements on international standards wherever possible, the TBT Agreement
represents a major step forward.  However, the breadth of its scope, and the number of its signatories,means that for practical reasons there must be a certain amount of “lowest common denominator” in
its regulatory approach.  It should also be observed that there is considerable scope to improve its
implementation.  Some progress has been made in two “triennial reviews” of the TBT agreement;
however, other issues remain unresolved.
39. Bilateral, regional and inter-regional initiatives in this area also offer potential for advance.
For example, principles on best regulatory practice agreed in the context of ASEM set out some useful
guidance for consultation; an exchange of information is foreseen under the FTA between the EC and
Mexico; and certain forms of co-operation are envisaged between the Community and the countries of
Mercosur.  Such initiatives could be regarded as a first step to the achievement of regulatory
co-operation.
40. Particular mention should be made of best regulatory practice: efforts to establish a common
understanding of the basic principles of good ways to regulate, such as exchanging information on
trade issues, transparency in programmes, clarity of  rules, fitting the regulatory approach to the
objective of the regulation, and the like.
41. Another important element of regulatory development is transparency.  The
European Commission places great importance on the issue: bringing the legislator closer to its
citizens and getting them fully involved in the pr ocess is a key priority.  While the principles of
transparency (such as public consultation and public access to official documents) are generally
shared, the ways these principles are implemented differ widely.  When regulators in different
countries co-operate, it is therefore important that they are aware of each other’s systems of
addressing transparency aspects and their impact on the regulatory process.
42. Two further points should be made.  First, agreements on paper need to be backed up by
concrete implementation.  Second, the EU itself should  continue to be flexible in its regulatory system
for trade in goods where mutual advantage can be gained by opening trade.
Practical measures in regulatory co-operation
43. The experience of the EU in the area of free movement of goods within the internal market
has shown that many obstacles stem from lack of understanding of legal and market requirements.
Removing such obstacles would be facilitated by the development and distribution of information on
certification, accreditation and standardization procedures.  It is therefore useful to organise
exchanges of information and institutional experience and specific requirements for sectors or product
categories.  Seminars, training sessions, joint visits, audits, surveys and information gathering can alsocontribute to the objective.G/TBT/W/173/Add.1
Page 11
44. This can lead to an indirect “bench-marking” process whereby regulatory authorities are made
familiar with other authorities’ experience, and amend their regulatory practice as a result.  The
identification of good regulatory practices can also lead to regulatory transparency and enhanced
market access.  The EU is pursuing this line in bilateral fora such as the Transatlantic Economic
Partnership (TEP) with the USA and in multilateral fora such as ASEM.
IX. HARMONIZATION
45. At the outset, it is perhaps necessary to underline the difference between harmonization and
international standardization, though obviously they have strong similarities.  In general,
harmonization may be regarded as the drawing up of common or identical rules by a group of
authorities, with the intention that the mandatory  rules governing a product or service shall be the
same among them.  International standardization  (in its broadest sense, i.e. including the drawing up
of technical specifications by public authorities) has as its aim the elaboration of a common set ofrequirements at international level, with the invo lvement of those who have a legitimate interest in
them: governments, economic entities such as industry, and users, without the intention that
mandatory rules and technical practice should always be the same.
46. This distinction is necessary, for it must be recognised that international standards are not
universally used, despite the call for their use in the TBT agreement as a basis for national andregional regulation and standardization where appropriate.  The coherence of regulations and of
standards can be achieved through harmonization, which has already proved its usefulness in the
context of the EU internal market.  Harmonization, both of rules and of standards, has the advantage
that it is clear that the rules are the same, and a supplier placing a product on the market can therefore
be confident that the same rules are applicable whatever the jurisdiction.
47. Some international regulatory harmonization is already in place.  Organizations such as the
Codex Alimentarius Commission, ICAO, IMO, and the like are already active in international rule-
making on an inter-governmental basis.
48. Harmonization, however, is a “maximal” option, that  is not always practical or even desirable,
for example because of its potentially high cost.  Harmonization of rules requires regulatoryadaptation, either through bringing one party’s rules into alignment with another’s (as is the case with
the applicant countries) or through the development of entirely new rules.  Such procedures are costly,
both in administrative terms and for suppliers of products that must conform.  In addition, attempts at
harmonization can run into political problems; for example, different regulatory systems may not be
compatible, and administrations may not wish to bring their regulatory systems into line with what
may be perceived as alien requirements, or may encounter difficulties in persuading their legislatures
of the expediency of doing so.
49. Finally, harmonization does not imply mutual recognition of certificates.  It is one thing to set
out rules that are identically the same, or technically compatible; it is another to accept that products
conform with the rules.  Even when the rules of two countries are the same, the acceptance of
certificates of conformity with them by one country is based on that country’s trust in the conformity
assessment procedures of the other.  In effect, therefore, to achieve full compatibility in regulatedareas, harmonization of regulations and standards will need to be matched with mutual recognition of
certificates of conformity, and market surveillance mechanisms on the parties’ territories must allow
for the placing on the market of goods that conform to the commonly agreed rules.
X. RECOGNITION OF EQUIVALENCE
50. Even where regulations or standards differ, progress towards mutual opening of markets may
be possible if they are recognised as equivalent.  Where the regulation in each territory has the same
regulatory objective as that in the other, and the two sets of regulations both actually fulfil thisG/TBT/W/173/Add.1
Page 12
objective, the authorities can agree to regard them as equivalent.  Then, they can agree that products
conforming to the other party’s regulations (where necessary, including relevant conformity
assessment and certification procedures) can be placed on the market in the territory of either party as
though it conformed to the rules in force there.
51. While potentially a powerful tool, and one recommended by the WTO TBT Agreement, this
mechanism can be technically complex in practice, wh ich perhaps explains why it is little used.  First,
the objectives  of a regulation have to be set out (this is done for EU legislation), then they have to be
agreed as being equivalent, and finally agreement has to be reached on their mutual acceptability.
This is a complex process, not least because it has to be done in detail, sector by sector; in addition,
any substantial revision or updating (for example, to take account of technical progress) is likely to
make a new determination and recognition of equivalence necessary.  For these reasons, this relatively
simple principle cannot be considered of general applicability.  Where it can be applied, however, it isa valuable instrument of trade facilitation while fully respecting the regulatory autonomy of the
parties.
52. Where harmonization is considered feasible, it is generally considered as a better tool than
equivalence.  Nevertheless, harmonization risks being a longer process than recognition of
equivalence.  Moreover, there may be non-techni cal reasons why harmonization is not an option,
where equivalence would help achieve a very similar result in terms of trade facilitation.  On the other
hand, where technical regulations differ radically, in particular in terms of the objectives they seek to
achieve, it is likely that a determination of equivalence will not be possible and that harmonization
will prove unfeasible.
53. With recognition of equivalence (which can be mutual or unilateral), a country accepts that
imported products that meet the applicable technical requirements of the exporting country are placed
on its market as if they met its own applicable technical requirements.  Recognition of equivalence of
standards may be envisaged in situations where no relevant international standards exist or their
completion is not imminent.  As an interim measure until suitable international standards are
developed, standards originating from other trading partners could be accepted as equivalent eventhough these standards are different from the domestic ones.
54. Recognition of equivalence does not imply, per se , recognition of conformity assessment.  It
does make sense, however, to combine the two, both  in terms of trade facilitation and in terms of
regulatory efficiency.  Together with recognition of conformity assessment, recognition of
equivalence of technical regulations ensures that a product needs to comply with only one set of
technical requirements and is tested and assessed only once, by the public or private conformity
assessment bodies that are most familiar with the requirements against which the product is beingassessed.
55. In order to achieve this result, however, two sets of conditions must be fulfilled.
56. First, the technical regulations must be equivale nt in their regulatory objectives.  This can be
determined either if the objectives are set out explicit ly, or if they can be determined in detail from the
regulations themselves.  The objectives should be very similar, if not identical, and the requirementsof each set of regulations should be capable of meeting the regulatory objectives of the other.  These
conditions are more likely to be met, in practice, when the two sets of technical regulations are based
on very similar standards or the same standard (for instance, international standards).G/TBT/W/173/Add.1
Page 13
57. Second, the two parties must have confidence in  the conformity assessment infrastructure of
the other party, in terms of technical competence, honesty, impartiality, independence, etc., of the
conformity assessment bodies of the other party7
Case study:  instances of equivalence
The EU “New Approach” legisl ation does not set mandatory standards, but recognises them
as a means towards achieving regulatory objectives: the standards are not mandatory, but
give “presumption of conformity” with the (obligatory) requirements of the relevant
Directive.
In an Agreement on Marine Equipment between the EU and the US, being negotiated in the
context of the EU-US Transatlantic Economic Partnership (TEP), the potential recognition
of equivalence of regulations would be based on the Conventions of the International
Maritime Organization (IMO), which form the technical basis for the regulations both of theEU and the US in this sector.
XI. MUTUAL RECOGNITION AGREEMENTS
58. Mutual Recognition Agreements are agreements on the mutual recognition of conformity
assessment of regulated products.  Through an MRA, each importing party is given the authority to
test and certify products against the regulatory requirements of the other party, in its own territory and
prior to export.  In cases where countries require mandatory third-party certification of specific
products, each importing party agrees, by the terms of the MRA, to recognise the tests, certificates
and approvals issued by agreed conformity assessment bodies of the exporting party, and the productscan be exported and placed on the other party's market without undergoing additional procedures.
The mandate received in 1992 by the European Commission on MRA and the following 1994 and
1998 negotiating directives authorised negotiations on a bilateral basis.  This has made possible the
MRAs currently in place, and (with a supplementary mandate) the Transatlantic Economic
Partnership (TEP) actions with the United States.  The mandate from the Council to the Commissionto negotiate mutual recognition agreements indicated the objective that the third countries concerned
will conclude with the EEA EFTA States parallel agre ements equivalent to those to be concluded with
the Community.  The system of parallel agreements protocols formally grants the third country
concerned the same market access throughout the European Economic Area for products covered by
the mutual recognition agreements.
59. MRAs do not require or presuppose harmonization of each party’s technical requirements, or
recognition of their equivalence.  Each party is fr ee to set its own regulations or standards, though the
partners to an MRA must obviously have concepts for product testing and approval that are broadly
compatible, and each party must have comparable - or at least mutually acceptable - systems of
certification and underlying technical infrastructures.  Once established, the MRA will need to be
maintained, for example by keeping lists of recognised certification bodies, and the standards or rules
against which they must certify.
                                                     
7It is worth pointing out the difference between recognition of conformity assessment in the contexts of
equivalence and of MRAs. In both cases, the parties must have confidence that the conformity assessmentbodies of the other party (public or private) present certain characteristics: adequate qualifications and trainingof their personnel, impartiality, independence from vested interests, technical competence to carry out tests, etc.
Under an MRA, the conformity assessment bodies of the exporting party must also understand the requirementsof the importing country and be competent to assess products for conformity with such requirements. Under
equivalence the conformity assessment bodies of an exporting country assess the conformity of a product with
the requirements of that country; thus, they do not need technical competence additional to what they need in thedomestic context.G/TBT/W/173/Add.1
Page 14
60. The benefits arise from removal of duplicated inspection or certification.  Where a product
intended for two markets may have to be assessed twice (when technical requirements or standards
are different), the assessment would be cheaper when carried out by the same body.  The time to
market is reduced since contacts between the manufacturer and the conformity assessment body, and a
single assessment, speed up the process.  Even where the underlying regulations are harmonised, forexample on an international standard, the need for recognition of certificates remains, and in such
cases the benefit will be clear: the product is assessed once against the commonly accepted standard
instead of twice.
61. Other benefits include increased transparency (all procedures have to be clearly laid down);
furthermore, contacts between regulators may lead to some harmonization, and transparency in
procedures ensures greater predictability, which makes it easier for companies better to plan their
market strategies.
Multilateral mutual recognition arrangements
62. Internationally in recent years multi-lateral agreements or arrangements have begun to be
concluded, either at government level or by regional organizations.  The underlying rationale is to
extend to a larger number of trade partners the benefits of easier market access.  However, because of
the involvement of a large number of parties, these arrangements often lead to increased complexity(owing to the wider range of differences in each system).
63. The contents of this type of MRA are often different in nature, involving either a limited
number of sectors or partial recognition leading to a lower level of trade facilitation.  This is the case
for most of the existing multilateral arrangements on mutual recognition, where the scope is generally
limited to acceptance of test reports performed by a laboratory in the territory of one party by theother parties, based normally on the use of commonly agreed or international standards.
Case study:  the APEC MRA
The Asia-Pacific Economic Co-operation (APEC)  MRA represents the best known example
outside the EU of a multilateral agreement.  APEC
8 has given its support, through the Osaka
Action Agenda, to the development of multilateral and bilateral mutual recognitionarrangements in the APEC region.  There are four sectors.
(a) The APEC Mutual Recognition Arrangement on Conformity Assessment of Foods and
Food Products  (APEC Food MRA) consists of  a framework arrangement (the
“Umbrella Arrangement”) and separate implementation arrangements (Sectoral
Arrangements).  The Sectoral Arrangements involve the acceptance by an importing
party that foodstuffs conform with that party’s requirements.
(b) The APEC model Mutual Recognition Arrangement on Automotive Products  is not an
arrangement in its own right, but a template or pro-forma  to be used by member
economies in entering into bilateral arra ngements.  Each party guarantees that
products exported under the arrangement comply with the list of harmonised
standards specified in the arrangement.  The harmonised standards will be based on
the equivalent UN/ECE standards.
                                                     
8APEC, established in 1989 in response to growing interdependence among Asia-Pacific economies,
began as an informal dialogue, but has since become the primary regional vehicle for promoting open trade
between its 21 member economies .G/TBT/W/173/Add.1
Page 15
(c) The APEC Mutual Recognition Arrangement on Conformity Assessment of
Telecommunication Equipment (APEC Tel MRA) comprises a framework
arrangement and two conformity arrangements (one relating to test reports and the
other relating to certificates).  Member economies are free to participate in whichever
of the conformity arrangements best suit their regulatory régime.
(d) The APEC Mutual Recognition Arrangement on Conformity Assessment of Electrical
and Electronic Equipment (APEC Electrical MRA ), like the Tel MRA, deals with the
recognition of test reports and certificates; however, the provisions are contained
within a single document.
Selecting an MRA: a review of experience.
64. The costs and benefits of MRAs have to be regarded in the light of political and commercial
competition aspects.  The Commission’s experience is that MRAs are only worth negotiating in the
following circumstances:
(a) where certification systems are not too different in principle and in practice; and
(b) where there are substantial, functioning regulatory, standards and certification infrastructure
and market surveillance infrastructures and capacities, that are comparable and compatiblewith those of the EU; and
(c) where trade between the parties is sufficient to justify the cost involved in setting them up;
and
(d) where the trade that is being liberalised offers some opportunities to open markets to
EU industry as well as to that of the third country, since political support from industry isevidently necessary if trade liberalization measures are to gain support.
65. MRAs do not remove some serious technical barriers to trade.  In some sectors, certification
activities are subject to restrictive government control.  There may be technical regulations that for
political or other reasons are not susceptible to modification.  There may be market sectors in which,
although products are in theory not subject to mandatory certification, it is inevitable in practice, forexample for market reasons (customers may demand certified products even though uncertified
products may be lawfully placed on the market).
66. MRAs cannot resolve such issues.  They are a trade facilitation tool, for use when the
potential partners have paved the way by bringing their systems close enough to make MRAs
workable, while either not addressing questions of harmonization, or accepting that harmonization is
too remote an objective to be practicable within any reasonable time-frame.
XII. PARTIAL, VOLUNTARY, REDUCED OR LESS FORMAL TYPES OF MUTUAL
RECOGNITION
67. Mutual recognition agreements require confidence on the part of each party, that the systems
for certifying products in the other are effective and can be relied upon to deliver an appropriate level
of protection.  This confidence may take some time to establish, since the authorities of each party are
effectively placing part of the task of enforcement of technical rules in the hands of bodies over whomthey have no direct control (though they may be said to have a degree of indirect control through their
relations with the authorities of the other party), and resistance to this is understandable where a
product may present a potential hazard.G/TBT/W/173/Add.1
Page 16
68. In effect, the parties to an MRA have agreed to share some degree of control over their home
markets in the relevant product area in exchange for the other party doing the same.  At early stages in
the operation of such an agreement, they may be unwilling to surrender a part of their discretion to
regulate their own markets.
69. In addition, if one party lacks the necessary te chnical infrastructure for an MRA, this may not
be the most appropriate instrument, for it requires comparable levels of technical infrastructure.  A
country with a more developed infrastructure may be able to deliver the requisite certificates to
another country, but if the latter has a less developed certification infrastructure, its conformity
assessment bodies may well not have the capacity to deliver certificates that can be relied upon by the
other party.  On the other hand, the less developed partner may have strict rules regarding control at
import that substitute for the lack of an effective market surveillance mechanism.
70. Mutual recognition can be broken down into a number of elements, which the classical MRA
includes as a package.  However, if it is regarded as premature to conclude an MRA, or if the political
willingness or technical resources for doing so are wanting, it may be possible to identify certain
elements that can be applied separately, on a stand-alone basis or as part of a group of measures that
fall short of a complete MRA.  An “MRA by steps” might consist of an umbrella agreement with
phased supplementary agreements to achieve regulatory co-operation, mutual recognition, or otherobjectives.  Political willingness to reach an MRA might be helped by a “package” approach in which
each side can gain a part of its wants in exchange for concessions from the other.
71. For example, in the pharmaceutical sector, good manufacturing practice (GMP) or good
laboratory practice (GLP) may be treated as part of an MRA; but they could be the subject of a stand-
alone agreement (one on GLP has been reached with Israel).  The traceability of measurementstandards offers another area for co-operation.  If the measurement standards used by laboratories on
the territory of one party are regarded as acceptable by the other, it will facilitate the acceptance of
test results.
Accreditation
72. One area particularly susceptible to development is accreditation: one of the more common
means by which a body is recognised as competent in certification, testing and associated functions.
In general, certification bodies are accredited to grant certificates of conformity by an accreditation
body in their own country or region.  The certification may be based on testing by accredited test
laboratories, similarly accredited to carry out tests for their own country or region.
73. The increasing development of contacts and agreements between accreditors is a reality and
this can certainly play a relevant role as a support to trade facilitation activities in the area of
conformity assessment.
74. Voluntary agreements between accreditors, certifiers, and test laboratories are already
increasingly being set up.  They take account of common experiences, and create networks for
interchange of information, technical work and practices.  Such activities are applied on a voluntarybasis by non-governmental parties, though governments can play a role in supporting and facilitating
agreements.  Support can be provided directly, by  promoting or financing exchange of information
and organization of events, or indirectly, by establishing or recognising a role for the existing schemes
in bilateral or multilateral agreements.
75. In addition, there is already a whole range of sub-contracting agreements in existence
between testing laboratories and certification bodies.  In such cases, while the leading organization
keeps the responsibility for whole or part of the conformity assessment, the partner laboratory carries
out most of the product testing.  This type of agreement is also very common at international level,
between organizations located in different countries.G/TBT/W/173/Add.1
Page 17
Case studies:  examples of accreditation activities9
At the regional European level, EA (European Accreditation) members can apply for peer-
group evaluation of their activities.  Successful members may sign the appropriatemultilateral agreement (MLA) for accreditation as certification body, laboratory or
inspection body under which they recognise and promote the equivalence of each other’s
systems and of certificates and reports issued by bodies accredited under these systems.
EA promotes the recognition and acceptance in all the MLA countries of certificates and
reports issued by organizations accredited by national accreditation bodies who have signed
the MLA.  The EA MLA aims at achieving a uniform level of competence of the accredited
bodies involved and to diminish or eliminate the need for multiple assessments.
The developing system of multilateral mutual  recognition agreements between laboratory
accreditation bodies within ILAC (International Laboratory Accreditation Co-operation)
based on peer reviews enables accredited laboratories world-wide to achieve a form of
international recognition, and allows their test data accompanying exported goods to be
more readily accepted on overseas markets.
Similarly, the IAF (International Accreditation Forum) is establishing multilateral mutual
recognition agreements globally based on the equivalence of conformity assessment body
accreditation programmes operated by accreditation body members, verified through peer
review among those accreditation body members.  The primary function of both ILAC and
the IAF is to develop voluntary world-wide recognition by setting programmes withcommon criteria for accreditation and conformity assessment, which contribute in the
elimination of non-tariff barriers to trade.   This effectively reduces costs for both the
manufacturer and the importers, as it reduces or eliminates the need for products to be
re-tested in another country.
The IECEE-CB Scheme is a multilateral agreement among participating certification
organizations in many countries.  Countries that are members of the International
Electrotechnical Commission IEC, may join the Scheme and can designate National
Certification Bodies CB.  The scheme uses Certification Bodies Test Certificates to attest
that product samples are in compliance with the requirements of relevant IEC standards and
with the declared national deviations existing in various member countries.  The Scheme is
therefore based on the use of international IEC standards, and the transparent exchange of
information of any deviation from those standards that can be nationally applied.  Amanufacturer utilising a CB test report issued by one of the member certification
organizations can obtain easy national product certification in all other countries of the
scheme.
Co-operation on the development of standards
76. Co-operation on the development of standards is also of value, for though in general standards
tend to enshrine existing technical practice, it will be economically beneficial for technical practices
to converge.
77. While measures of this kind fall short of actual harmonization, nonetheless they serve to build
up confidence and develop an environment that is, over the medium to long term, conducive to the
convergence of technical rules.  Once confidence has been built up, more elements of mutualrecognition and convergence can be introduced, if necessary sector by sector.
                                                     
9EA (European Accreditation) is an organisation of national accreditation organizations in Europe.
ILAC (International Laboratory Accreditation Co-operatio n) unites laboratory accreditors at world level; IAF
(International Accreditation Forum) is its analogue for certification bodies.G/TBT/W/173/Add.1
Page 18
XIII.  INTERNATIONAL STANDARDIZATION
78. In addition to the harmonization of regulatory requirements, international standardization has
become important as a means of establishing technical requirements at the international level, in
principle for voluntary application.  The classical international standards bodies IEC and ISO have
been established for many years, and have established a position at the world level.  Particularly in thecase of the IEC, it may be said that internationali zation of the technical practice in the area it covers
(the electrotechnical sector) has been a substantial success, at least in some areas (for example, the
standards according to which electrical equipment is built are much the same across the world).
79. As mentioned above, the WTO TBT agreement gives a certain priority to international
standards – where they exist - as a basis for technical regulation (by governments) and for national
and regional standardization (by recognised standards bodies at the national and regional levels).  But
this is by no means an absolute requirement, and can be deviated from where appropriate where theWTO Member has a legitimate reason for doing so.  Such reasons, however, must relate to the
legitimate objective of the regulation or standard.  Of course, if international standards are lacking,
WTO Members are free to standardise or regulate as they see fit.
80. International standardization has some advantages: a single solution agreed across the global
economy will open trade to the extent that it unifies technical practice, provides a globally acceptedreference, and promotes the economic benefit that derives from the elimination of divergent though
technically equally valid solutions while leaving room for competition of diverging products.
81. Nonetheless, there continue to be problems with  the international standards system as it has
evolved.  One is the proliferation of bodies: the OECD and the WTO have both identified a large
number of organizations that draw up technical specifications for international use, for example, IEC,ISO, ITU, OECD, UN-ECE and OIE all made presentations at a WTO meeting on the subject.  New
bodies continue to emerge, such as GHTF, W3C and IETF
10.  In some cases, the members of these
bodies are governments; in others, standards bodies; in others, industry federations or even individual
commercial enterprises.  Although the position in th is respect remains not entirely clear, some basic
principles for the development of internationa l standards have emerged from the WTO Triennial
Review of the TBT Agreement and it is to be hoped that they can now be developed further.
82. Furthermore, there is some difficulty in establishing timely responses to regulatory needs.
The international standardization process can be pa infully slow (typically four or five years from
proposal to publication); and priorities do not always appear to be set by the needs of international
trade.  As a result, even the EU, which is the lead ing participant in international standardization, and
has a strong commitment to it, has made relatively limited use of international standards as the basis
for technical legislation and the opening of trade.
83. In addition, there is still no established mechanism by which governments can call upon the
international standards bodies (as distinct from inter-governmental bodies) to draw up international
standards that can then be used in support of a common regulatory structure.  Work towards devising
a mechanism to do this is under way in the c ontext of the UN Economic Commission for Europe.
However, it is at a preliminary stage, and support at the world level is yet to be sought.
84. In short, it may be said that international standardization offers a potential route towards
commonality in the regulatory environment. This is to an extent demonstrated by the experience of
                                                     
10OECD: Organisation for Economic Co-operation and Development. ITU: International
Telecommunications Union. UN-ECE: United Nations Economic Commission for Europe. OIE: Office
International des Epizooties. GHTF: Global Harmonization Task Force. W3C: World Wide Web Consortium.IETF: Internet Engineering Task Force. All these organizations – and many others – make specifications,standards or technical regulations (the difference is not always entirely clear) at the global level.G/TBT/W/173/Add.1
Page 19
the EU in using regional standardization as a tool for the development of its own internal market.  At
present, however, the effectiveness of international standardization is somewhat limited, though active
efforts are being made to pursue it within intern ational standards bodies, and to improve alignment of
national standards on international ones in a number of fora.  In general, Europe is strong in
international standardization, and this tool offers Europe an opportunity to promote its system.  Tothis end, the Council has requested the Commission to develop guidelines for a European
standardization policy in the international context.
11
XIV. TECHNICAL ASSISTANCE
The aims of technical assistance
85. Technical assistance offered by the EU in the context of programmes whose main objective is
to pursue targets based on broad EU objectives, the partner country’s policy agenda, analysis of thepartner country's situation, and the activities of the major partners.  Particularly in the case of
developing countries, the system of trade preferences is not the only element to favour the
development of exports.  Technical assistance to develop the supply side is necessary; technical
assistance in the field of standards and conformity assessment can contribute to ensuring that
requirements for products are met.
86. In this context, the type of assistance will depend upon the situation and the level of
development level of the recipient country.  In addition, the results of that assistance should be
sustainable with the recipient's own resources.
87. Technical assistance actions can aim at reducing TBTs; and raising awareness of TBTs and
the need to reduce them; helping recipients to fu lfil EU requirements; at preventing the export of
unsafe products; at the preparation of agreements to reduce TBTs; at preparing recipients for
membership of the WTO; at helping recipients to implement the TBT agreement effectively; at
preparing recipients for MRAs or free trade agr eements; at gaining support for the EU approach; at
building up necessary institutions and other facilities; and at the encouraging economic and socialdevelopment of the recipient country.  This list is not exhaustive: there may be other reasons for
technical assistance.
88. Such programmes can help developing countries to develop a regulatory, standards and
conformity infrastructure; to encourage the adoption by developing countries of international and
European standards, to improve their infrastructure and set up accreditation and standardizingsystems, and to train officials in developing technical regulations and standards.  It is in the interest of
both the Community and the third country in question to be helped to produce better quality or safer
products, so that developing countries’ products can be traded with developed countries in full
compliance with relevant requirements for the protection of health, safety, etc.  The Community also
has an interest in promoting consumer demand in third countries for high-value Community products.
89. Some partner countries have now reached a stage of economic and industrial development
where basic infrastructures - such as a functional standards body, a range of basic industrial standards,and testing laboratories - are in place.  Assistance may therefore be directed towards areas such as
improving the regulatory regime for specific sector s, refining the infrastructure necessary for mutual
recognition agreements to be concluded, and pr omoting European and international regulatory
approaches, including approaches to conformity assessment.  Where technical conditions are met,
mutual recognition can be one of the objectives.  The Community's own single market experiencemay provide a relevant model for many areas of the world considering regional systems.
                                                     
11Council Resolution of 28 October 1999, OJ C141 of 19.5.2000, p. 1-4G/TBT/W/173/Add.1
Page 20
Types of technical assistance
90. Independently of what assistance is provided, the recipient has to have the capability and
motivation to take advantage of and apply the results of the assistance.  Two most effective methods
are “learning by doing”, and exchanging experiences in practical work.  When the recipients’ needsand priorities are not clear, assistance for assessment of the situation might be a good starting point.
Support for investment requires that necessary structures and resources are in place.
91. Assistance might take the form of assessment of the situation in the country, enabling
developing countries to assess their needs and priorities; information seminars and workshops;
awareness conferences and campaigns; training courses, including training trainers; “hands-on”
training in European public and private organizations; participation in the work of internationalorganizations; regional co-operation activities; expert advice; institution-building (creating and
reinforcing relevant organizations); and investment.
92. Where the aim of the assistance is to reduce technical barriers to trade, EU policy is to spread
the European approach to reconciling regulatory and trade objectives.  Accordingly, assistance may
focus on the New and Global Approaches; harmonization of legislation and regulations;standardization, accreditation, inspection, testing and certification (and conformity assessment in
general); marking, metrology and market surveillance.  Target groups include public authorities
(including customs services), standardization accreditation and conformity assessment bodies,
economic operators, including manufacturers and trade organizations, testing laboratories and
consumer groups.
Delivering technical assistance
93. EC technical assistance is usually provided as grants, though there may be a requirement for
the recipient to pay a share of the investment (typically 25%).  EU financing of the assistance may be
through multi-annual programmes with projects and sub-projects, or as single projects.  Agreements
for assistance can be made at different levels, for example, government to government, region togovernment, region to region, private organization to private organization, or within multinational
private organizations.
94. In deciding on technical assistance, it is necessary to take into account such factors as:
co-ordination with other assistance projects, completed, existing or planned; the possibility of pooling
resources for funding; the possibilities of regional co-operation, and other bilateral and international
assistance; the state of existing institutions and other facilities; whether the recipient is member of
WTO TBT, and where appropriate, its fulfilment of its obligations under the TBT Agreement andother TBT problems; the long term (about five-year) infrastructure strategy, the priorities and realism
of present development plans and proposed projects, including financing and human resources; the
sustainability of the results of proposed assisted activities; the management of such activities, and
political considerations.
Case studies: some EU technical assistance projects
A. A project on Standards and Conformity Assessment for a non-candidate Eastern European
country  is intended to facilitate the transition to a market economy, and integration of the
country and its companies into the global economy.  Assistance will be provided to help
bring about a significant reduction in the number of products subject to compulsory pre-
market third party certification; where appropriate, to introduce manufacturer’s declarationsof conformity; to help draft horizontal legislation, in particular on conformity assessment
and product safety; to help in consolidating the distinction between compulsory technical
regulations and voluntary standards; to help in any matter related to compliance with theG/TBT/W/173/Add.1
Page 21
WTO TBT agreement (in particular, the operation of the Enquiry Point); to cover
organizational matters within the standardization body, and between it and other
organizations involved in activities in the field; and to acquaint officials with the
implications of the move towards EU and in ternational systems of standardization and
conformity assessment.
B. A project on Standards and Quality in  an Asian least developed country  has the objective of
contributing to efforts in the country’s transition to a market economy.  The specific purpose
is to improve quality at institutional and enterprise level.  Assistance is provided to
strengthen the quality structure of industry; encourage and facilitate the understanding and
use of standards and technical regulation by industry, particularly in the context of exports;
provide industry and regional centres with well based and reliable metrology and calibration
services; provide companies with internationally recognised and accepted testing andproduct certification services; improve the quality of products through introduction of a
quality management system based on international standards and certification; and establish
a national accreditation scheme for laboratories and certification bodies.
C. A South American regional programme provides technical support to countries in the region
for activities and co-operation in the quality infrastructure field.  It includes financingparticipation of technical experts in international meetings and knowledge transfer from
Europe.  “Sub-projects” cover training of quality auditors and quality trainers; assistance to
SMEs to obtain quality certification according to ISO 9000; assistance to set up national
information and notification systems in the participating countries; support to the
participating countries for developing regional standardization activities and applying theEuropean INES system; assistance to develop certification and accreditation systems
according to international models; creation of consistent legal and industrial metrology and
reinforcing capabilities in these fields in the participating countries; and reinforcing regional
information centres for SMEs in the field of standardization and quality.
95. These three examples contain a variety of components; however, all contain the characteristic
elements of support for information and training, development of legislation and regulations and
implementation by setting up and improving procedures and developing organizations.
96. When the development of the basic quality infrastructure has progressed, technical assistance
for specific issues such as participation in intern ational work, solving trade problems and support for
investment become more widespread.  It should be recognised that despite the existence of typical
patterns, the situation of each potential recipient is unique.
XV. IMPLEMENTING SYSTEMS
97. It is not sufficient to make agreements; there must be reasonable confidence that they will be
adhered to.  Experience has demonstrated that if the capacity, or the political will, to implement an
agreement is missing, then the agreement itself will remain merely words; and a well-intentioned
agreement that goes beyond the ability or willingness of any party to implement it will do more harmthan good, since the entire concept will become discredited.
98. Consequently, any agreement to facilitate trade should be accompanied by genuine readiness,
capacity and willingness to implement it.  This implies, among other things, that the relevant bodies
(for example, legislative or governmental entities) in both parties to a negotiation ought to be involved
in it, and there should be a reasonable expectation that they can and will implement the results.Ultimately, agreements of this type depend upon the commitment of the parties to carry them out, and
it is better to determine what can realistically be delivered, rather than to agree an ambitious
programme, only to find that what can be agreed on paper cannot be implemented on the ground.G/TBT/W/173/Add.1
Page 22
XVI. CONCLUSION:  SELECTING THE RIGHT INSTRUMENT
99. Analysis of trade facilitation measures in the area of technical regulation, conformity
assessment and certification shows that a range of instruments is available.  Selection of the right
instrument will depend on the characteristics of the markets, the regulatory environment in the third
country or region concerned, and the willingness on the part industries, regulators and other parties toachieve the agreed objectives.
100. In any case, the sectors in question should offer clear opportunities to facilitate access by
EU industry to foreign markets; at the same time it should guarantee the functioning of the
EU internal market without undermining its principl es.  Trade facilitation measures can also be used
to promote the regulatory approaches experienced in the EU, which have proved their advantage in
the establishment of the single market.  Different sectors will often have different needs.  For
example, if there is an established corpus of international rules already in place (the example ofmarine equipment has already been quoted), then harmonization and / or equivalence can be based on
such rules.
Particular characteristics of the partners to an agreement
101. Asymmetries in requirements between the partners may be an obstacle in particular sectors.
They may arise from differences in regulatory practice, for example, ex ante  certification, active
market surveillance by governmental agencies, or ex post product liability based on the aggrieved
customer’s right to sue the supplier.  They may also arise from fundamental differences in
technological practice.  Such problems may not easily be reconcilable by recognition of certificates or
common standards, particularly if one party maintains a more liberal régime than another.  Oneavenue to explore in this direction is the possibility of multi-sectoral agreements , possibly involving
different instruments.  But this will require a su bstantial degree of administrative sophistication, and
will clearly be more difficult to accomplish than a simple mutual agreement in a single sector.
102. If several trading partners have economies that are well integrated with one or more other
local partners, then a further problem may arise in making an agreement with one, without making
agreements with all of them.  If trade between the EU and a particular country is facilitated, for
example through an MRA, and if the partner country is a regional trading centre, full of goods being
exported or imported elsewhere, then goods in the partner country originating from its local partners
will enter the European market on the back of the MRA, though the local partners have made nosimilar agreement with the EU, and therefore EU exports to these countries will not enjoy the same
advantages.  “Rules of origin” or similar provisions are likely to be ineffective, because the EU will
have no means, and the partner country no incentive, to enforce them.  The decision to conclude an
agreement with such countries must bear this risk in mind; either the possibility of facilitating trade on
an asymmetrical basis “through the back door” will have to be tolerated, or agreements with such
trading centres may have to depend on the ability to make agreements with all of the local partners.
An approach to identifying the tool to use
103. The EU is already actively engaged in a substantial number of activities, in all of these areas,
some of which have been described in detail above.  As well as the MRAs in place or planned, there
are other activities, such as the ASEM dialogue on standards (as part of ASEM’s Trade Facilitation
Action Plan) and the Transatlantic Economic Partnership.  Through agreements with the European
standards bodies, the EU is a major supporter of international standardization, and is active in the
WTO Technical Barriers to Trade (TBT) Committee.
104. Future trade facilitation activities should continue  to make use of all the various tools that are
available.  A systematic approach  to identifying the tool to use might be based upon an assessment of
the potential for increased trade; the nature of the barriers (different standards, certificationG/TBT/W/173/Add.1
Page 23
procedures, market surveillance capacity, etc.); the political will among the parties to reach a solution
(for example, if a government agency in a particular country is known to be systematically
uncooperative, it may not be worth the effort if the agency’s co-operation is needed in another sector);
the desire among economic operators for an agreement; and the relative regulatory capacities of the
parties.
105. At the same time, factors other than trade will need to be taken properly into account.  For
example, where regulation has a legitimate aim such as safety, any moves intended for trade
facilitation must leave the necessary level of protection in place.  Furthermore, the parties to an
agreement may find it politically necessary to maintain a degree of regulatory autonomy.
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