WORLD TRADE
ORGANIZATIONG/TBT/W/194
10 March 2003
(03-1353)
Committee on Technical Barriers to Trade Original:  English
A POLICY FRAMEWORK FOR THE ACCEPTANCE OF RESULTS OF
CONFORMITY ASSESSMENT PROCEDURES
Submission by Japan
I. INTRODUCTION
1. Articles 6.3 and 6.4 of the Agreement on Technical Barriers to Trade (hereinafter,
TBT Agreement) encourage the negotiations of Mutual Recognition Agreement (MRA) and
participation of conformity assessment bodies located in the territories of other Members in Members’
conformity assessment procedures.  Article 6.1 further stipulates the obligation of Members to
"ensure, whenever possible, that results of conformity assessment procedures in other Members are
accepted, even when those procedures differ from their own."
2. Paragraph 27 of the Second Triennial Review of the Operation and Implementation of the
TBT Agreement noted "the existence of different mechanisms to facilitate acceptance of results of
conformity assessments, e.g. mutual recognition agreements for conformity assessment to specific
regulations; in the voluntary sector, co-operative arrangements between domestic and foreign
conformity assessment bodies; the use of accreditation to qualify conformity assessment bodies;
government designation; unilateral recognition of results of foreign conformity assessment; and
manufacturer’s/supplier’s declarations", and attached an indicative list describing these different
approaches.  The paragraph also noted that "this list was not intended to prescribe particular
approaches that Members might choose to adopt as it was recognized that the application of different
approaches would depend on the situation of Members and the specific sectors involved".TBT Committee, in paragraph 28, agreed to "further discuss the different approaches with a view to
analysing them in the light of Articles 5 and 6".
II. PURPOSE
3. The purpose of this submission is to encourage Members to accept results of conformity
assessment, taking into account each Member’s actual situation, by showing the benefit of acceptanceof results of conformity assessment procedures conducted outside the importing country, the different
approaches to realize the acceptance and their characteristics, as well as Japan’s experience.  "One
standard, one test, accepted everywhere" is the most desirable approach to reduce technical barriers.
However, approaches in this submission do not presuppose harmonization, or recognition of
equivalence, of each Member’s technical regulations or standards.
III. BENEFIT OF ACCEPTANCE OF CONFORMITY ASSESSMENT RESULTS
CONDUCTED OUTSIDE THE IMPORTING COUNTRY
A. R
EDUCTION OF TIME AND COST ASSOCIATED WITH CERTIFICATION /TESTING
4. The reduction of time and costs on conformity assessment procedures for exporters can be
realized through enabling all or part of the procedures required in the importing country to be done inG/TBT/W/194
Page 2
the exporting country,  and, even where the technical regulations or standards are different, through
conducting testing of products for home overseas markets.  The effect especially increases when
exporters face a heavy burden of foreign conformity assessment, such as complexity of the regulations
or associated procedures, the difficulty to foresee the result of conformity assessment, and/or lack of
sufficient number of competent certification bodies/lab oratories.  Regulatory authorities, certification
bodies, and user enterprises in the importing country can also decrease their cost as they no longer
need to conduct conformity assessment by themselves.  In addition, if appropriate, regulatory
authorities no longer designate or supervise certification bodies.  Thus the possibility of unnecessary
obstacles to trade, which are related to conformity assessment procedures, can be reduced.  Cost
reduction for exporters would include direct expenses, e.g. cost associated with holding foreign
branches, labor cost, mailing cost, and translation cost, as well as recovering opportunity cost by
shortening the period for putting products into the market.
B. INCREASING TRANSPARENCY , HARMONIZATION OF BOTH SYSTEMS
5. Regardless of the kind of approaches, mutual understanding between both parties on technical
regulation, standard, and conformity assessment procedures is important when accepting conformity
assessment results.  Therefore, consultation/dialogue between parties in various levels is necessary.
Such consultation/dialogue leads to mutual understanding on each system, which increasestransparency and could ultimately lead to harmonization of both systems.  This aspect also contributes
to reduction of technical barriers to trade.
IV. VERIFICATION OF BENEFIT BY THE ACCEPTANCE OF RESULTS OF
CONFORMITY ASSESSMENT PROCEDURES
6. The acceptance of conformity assessment results incurs a certain cost for constructing a
system and maintaining it regardless of the approaches chosen.  Therefore, demonstrable benefit
justifying the cost is needed.  Elements to estimate benefit of the acceptance include:
- (Potential) trade volume of products under specific regulation;
- Degree of burden to conduct conformity assessment procedures under a certain system in
importing country;  and
- Support from interested parties.
7. In addition, there are a lot of policy tools to promote trade liberalization/facilitation, e.g. tariff
reduction, simplifying customs procedures, providing proper investment environment.  So it is
important to decide whether a tool of acceptance of conformity assessment results is worth
considering by comparing it with other tools for trade liberalization/facilitation from the viewpoint of
cost and benefit.
V. APPROACHES TO REALIZE THE ACCEPTANCE OF CONFORMITY
ASSESSMENT RESULTS AND THEIR CHARACTERISTICS
A. MRA
S TO SPECIFIC REGULATIONS
8. This approach set forth the obligation of governments to accept results of conformity
assessment procedures (e.g. certification, testing, and calibration) by concluding a government-basedagreement.  Conformity assessment procedures under domestic regulation are primarily conducted in
importing country. In this approach, each government recognizes the equivalence of the results of
conformity assessment, required under the regulations of the importing country, done in the exporting
country and mutually accepts the results.  Japan has concluded an MRA with the European
Community in 2001 on electrical products, telecommunications terminal equipment and radioG/TBT/W/194
Page 3
equipment, GLP for chemicals and GMP for medica l products, and also with Singapore in 2002 on
electrical products and telecommunications terminal equipment and radio equipment.
9. Before concluding an MRA, both parties need to confirm their comparability of the regulatory
scheme and the equivalency of technical competence in accordance with Article 6.1 of the TBT
Agreement.  If both countries’ regulatory schemes differ in principal elements such as the subjectresponsible for certification (government, private third party, or suppliers’ declaration), an MRA is
difficult to conclude because it is impossible to  confirm the comparability and technical competence
under the same mechanism.  Even if the same mech anism applies in both countries, an MRA is also
difficult in the case that technical competence of conformity assessment bodies is different.  Principal
difference in regulatory schemes often arises when one country applies government certification while
the other applies private third party certification.  When technical competence of the private third
party in a country adopting government certification system is low, providing technical assistance isnecessary to improve the technical level of the country’s third party organization.  After the country
moves to third party certification system, a confirmation is still necessary on whether the new system
works well.  It should be noted that, generally, a recipient country of technical assistance never has
the same technical competence as donors.
10. This approach requires frequent consultation between governments for a long period to
confirm the comparability of the systems and technical equivalence between them before concluding
the agreements, as well as to confirm the efficacy of the agreement after its conclusion.  In the case
that the regulatory scheme involves third party certification, exporting government has to designate
certification organizations as well as undertake follow-up measures against them in accordance with
the criteria and procedures in importing country.  Therefore, administrative cost is very high for thisapproach.  Additionally, importing regulatory auth orities, from the viewpoint of ensuring human
health or safety, tend to tread warily towards this approach because the importing regulatory authority
has to entrust exporting country with the power to designate foreign third party organization.
11. On the other hand, this approach could lead to harmonization of both countries’ systems or
regulatory reform through mutual understanding stimulated by intensive dialogue.  Somemanufactures of products to advocate self-declaration conversely point out that this approach has a
fault to fasten current regulatory scheme by concluding government-based agreement.  Time and cost
reduction for certification/testing is the highest in this approach because acceptance is obligatory by
government-based agreement and necessary procedures have been completed in the exporting country
when certification accepted.  In addition, further cooperation on regulation between two countries,
such as recognition of equivalence or harmonization of technical regulations of both countries, is
expected taking into account the similarity of both systems to enable an MRA.
B. A
RRANGEMENTS AMONG CERTIFICATION BODIES
12. A participant (e.g. private certification body, testing laboratory, calibration laboratory) of this
arrangement promises the acceptance of conform ity assessment procedures conducted by other
participants.  In Japan, for example, three private certification bodies participate in IECEE/CB scheme
and mutually are accepting the results of certification internationally.
13. As private certification bodies conclude this arrangement based on their will and
responsibility with no government intervention, gene rally quick and flexible arrangement is possible.
Based on this approach, not only non-mandatory fields, but also regulatory authority could utilize it,
i.e. regulatory authority could accept conformity assessment results conducted by foreign certification
bodies through domestic certification bodies.  This approach is easy to handle for regulatoryauthorities because utilization and the degree of utilization are within their discretion.  Active
utilization of this approach is desirable.G/TBT/W/194
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14. The acceptance of conformity assessment results is under responsibility of participating
certification bodies.  So a regulatory authority cannot oblige certification bodies, subject of this
arrangement, to accept the results of foreign conformity assessment procedures.  However, a
regulatory authority can accept all the results of foreign conformity assessment once domestic
certification bodies accept them based on this arrangement.
15. As a step-by-step approach, it is desirable for regulatory authorities firstly to utilize this
approach in mandatory fields, and after accumulating experience, to proceed to binding MRAs, if
appropriate.
C. UTILIZATION OF ARRANGEMENTS BETWEEN ACCREDITATION BODIES
16. A participant of this arrangement recognizes the equivalency of the system, ability and results
of accreditation (e.g. accreditation of testing labor atory, calibration laboratory, and bodies operating
certification/registration of quality/environment management systems) conducted by otherparticipants.  A participant is also obliged to promote utilization of accreditation results by other
participants to relevant mandatory regulation.  In Japan, for example, two organizations participate in
IAF and PAC, two organizations in ILAC, f our organizations in APLAC, respectively.
17. Regulatory authorities, in mandatory fields, can utilize this arrangement by using
accreditation results conducted by foreign accreditation bodies participating in this arrangement, aswell as by using certification results conducted by certification bodies accredited by participants of
this arrangement.  The use of this arrangement is promoted when criteria for accreditation under this
arrangement is based on relevant guides or recommendations issued by international standardizing
bodies, and when participating accreditation bodies are mutually checking their abilities by peer
reviews.  Currently, a certain number of arrangements already exist, so additional cost to utilize thisapproach is relatively low.
18. On the other hand, if accreditation criteria on mandatory regulation deviate from international
standards, the benefit becomes smaller.  Regulatory authority has no means to confirm the
appropriateness of peer reviews among accreditation bodies nor has little room to take part in
accreditation procedures.  Thus, in order to promote utilization of this approach, it is important forregulatory authorities to have a means to ensure appropriateness of accreditation conducted by
participants of this arrangement.
D. D
ESIGNATION BY IMPORTING REGULATORY AUTHORITY
19. As to specific regulations, there exist schemes where importing regulatory authorities
designate foreign certification bodies.  In Japan, for example, a lot of regulations as to various
products, e.g. electrical products, gas equipment,  consumer products, telecommunication equipment,
JIS/JAS marking system (non-mandatory), permit such designations and actually a considerablenumber of foreign certification bodies are designated under some regulatory schemes.
20. Under this approach, conformity assessment conducted by designated foreign certification
bodies has the same legal effect as that by domestic certification bodies.  Therefore, the same benefit
as a government-based MRA can be achieved as to the designated foreign bodies.  Administrative
cost associated with this approach is much lower than a government-based MRA.  Especially, noadditional administrative cost incurs in the case that importing country’s relevant regulation has
already built-in foreign designation scheme.  This approach is relatively acceptable by importing
regulatory authorities because they still maintain designation powers.  This approach is especially
useful when the number of certification bodies in the exporting country is small or a government-
based MRA is difficult because of lack of equi valency as a whole country but some certification
bodies in exporting country is enough capable.G/TBT/W/194
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21. On the other hand, by utilizing this approach, understanding of regulatory systems extends
only to the certification bodies involved and there is nothing to do with exporting country’s system.
Therefore, the motivation for regulatory reform in both countries is limited.
VI. CONCLUSION
22. The acceptance of results of conformity assessment procedures conducted outside the territory
of importing country has an effect to reduce associated time and cost, as well as to lead to
harmonization of both countries’ systems.  On the other hand, regardless of the kind of approaches,
technical equivalence of conformity assessment is required.  In the case that the technical level of both
parties is different, equaling the technical competence through technical assistance, etc. is a
prerequisite for the acceptance of conformity assessment results.  Furthermore, to pursue the
acceptance, demonstrable rationale is needed by comparing cost and benefit of this approach with
other trade policy tools.  After these conditions are met, taking into account each party’s actualsituation, the most appropriate approach should be  chosen and pursued comparing cost and benefit
associated with each approach.
23. Though a government-based MRA has much effect among various approaches of accepting
conformity assessment results, conditions to conclude it is very strict, administrative cost is high, and
generally long-term negotiation is necessary.  In this respect, designations by importing country’sauthorities are useful when the number of conformity assessment bodies in exporting country is small.
It has the same effect as an MRA concerning the designated foreign conformity assessment bodies.
Utilization of arrangements among private sectors is also useful because regulatory authorities have
no binding obligation of acceptance.  Arrangements among certification bodies are generally rapid to
conclude and have certain flexibility.  As regulatory authorities have discretion to utilize thearrangements among certification bodies, this approach is easy to handle for regulatory authorities.
This approach is desirable to be utilized actively.  As to arrangements among accreditation bodies, a
certain number of arrangements in which a certain level of competence is maintained through peer
reviews already exist.  Therefore additional cost to utilize them is relatively low.  Furthermore, not
only utilization of results of certification, but also utilization of accreditation is available.
24. In order to conclude a government-based MRA to complete all the necessary conformity
assessment procedures in exporting countries, comparability of the systems and equivalency of
technical competence are required.  If such equivalency does not exist, an MRA is generally difficult
unless taking various steps.  One example of step-by-step approach is as follows:
− Firstly, giving technical assistance to the country where government certification is
adopted and technical competence of private certification bodies is low;
− Secondly, moving to third party certification system and keeping proper
implementation of the system;
− Thirdly, accumulating experiences of acceptance of conformity assessment results on
a non-binding basis by using arrangements among private sectors;  and
− Lastly, considering a government-based MRA.
Another approach might be the following:
− Firstly, partly accepting conformity assessment results by using designation by
importing country and accumulating experiences;  and
− Next, moving to a government-based MRA.G/TBT/W/194
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25. Needless to say, in order for importing country  to accept the results of foreign conformity
assessment, it is prerequisite that the exporting country ensures the proper implementation of the same
or the equivalent conformity assessment procedures as those of importing country.  Especially it
should be noted that government has a responsibility to ensure overall systems to maintain human
health or safety, etc.  In this sense, the acceptance of conformity assessment results is not realizedwithout mutual understanding and confidence buildin g between both parties.  Furthermore, it is
important for each government to use internati onal guides and recommendations for their conformity
assessment procedures.  Article 5.4 of the TBT Agreement plays an important role in this respect.
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