G/TBT/GEN/288  
 
12 March 2020 
(20-1968) Page: 1/6 
Committee on Technical Barriers to Trade    
 
 THEMATIC  SESSION ON CONFORMITY ASSESSMEN T PROCEDURES:   
CASE STUDIES OF PRAC TICAL EXAMPLES OF HO W MEMBERS ARRIVE AT THE 
ACCEPTANCE OF CONFOR MITY ASSESSMENT RESU LTS1  
25 FEBRUARY 2020, 1 5:00-18:00 
Moderator's Report2  
The Moderator of the Thematic Session on Conformity Assessment Procedures  delivered this Report 
at the WTO TBT Committee's meeting of 26 -27 February 2020.  
 
_______________  
 
 
At the Eighth Triennial Review, Members agreed to continue to hold thematic sessio ns in conjunction 
with its regular meetings during 2019 to 2021, with a view to further deepening the Committee's 
exchange of experiences on specific topics, and to hold a session on conformity assessment 
procedures (CAP) in February  2020 with a  focus on: Certificates of free sale ; and, Case studies of 
practical examples of how Members arrive at the acceptance of conformity assessment results .3 The 
programme for the thematic session is contained in the Annex of this report. The presentations 
summarized below are available through the WTO website.4  
 
Panel  
1.1.  Mr. Kissinger Ntsako Nkuna5 (South Africa ) described how Certificates of Free Sale (CoFS) 
create challenges for exporters and regulators. He said that a CoFS is an official document issued 
by a government or government regulatory authority, attesting that a specific product meets the 
domestic regulatory requirements of the exporting Member and that a product is freely available for 
purchase by the general public on the domestic market. A growi ng number of countries, including 
WTO Members, require that imports possess CoFS in order to receive custom clearance and market 
access; without the CoFS , market access is denied.  The types of products subject to CoFS 
requirements include agricultural prod ucts, certain chemicals, pharmaceutical products, cosmetics 
and food. There are a range of challenges created by CoFS, including: possible inconsistency with 
WTO provisions on non -discrimination as contained in the TBT Agreement and GATT; that CoFS are 
not based on relevant international guides and recommendations for conformity assessment 
procedures; that they create a de facto ban on products manufactured for the export market only 
due to the impossibility to obtain a CoFS; the difficulty to obtain CoFS f or products comprised of 
multiple components produced in global value chains; Members requiring CoFS do not provide 
information on the legitimate objective pursued; and, that CoFS improperly place product liability 
on the exporting Member government. South  Africa recommended that the TBT Committee convene 
a technical discussion on CoFS, and that Members requiring CoFS replace them with appropriate 
technical regulations and conformity assessment procedures as a matter of urgency and seek 
technical assistance  in this respect as needed.  
 
1 The final programme was circulated as G/TBT/GEN/286 . It is also in Anne x I of this document.  
2 Mr. Anatoly Chaplin (Russian Federation ). This Report is provided on the Moderator's own responsibility.  
3 G/TBT/41 , para. 8.2.a.iv, footnote 301; JOB/TBT/350 . 
4 https://www.wto.org/english/tratop_e/tbt_e/thematic_session_standard_121119_e.htm  
5 Department of Trade and Industry  G/TBT/GEN/288  
 
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  1.2.  Mr. Warren Merkel6 (United States ) described how the United States Consumer Product 
Safety Commission  (CPSC)  utilizes a combination of approaches mentioned in the TBT Committee 's 
"Indicative List " to facilitate acceptance of conformity assessment results for children 's products . 
The Consumer Product Safety Improvement Act of 2008 , which  enhanced several statutes, generally 
requires that children 's products:  (i) comply with all applicable children 's product safety rules ; (ii) be 
tested for compliance by a CPSC -accepted accredited laboratory, unless subject to an exception;  
(iii) h ave a written Children 's Product Certificate that provides evidence of the product 's compliance; 
and (iv) h ave permanent t racking information affixed to the product and its packaging where 
practicable.  It was highlighted that, given that the law specifies the use of accredited laboratories , 
the challenge in developing the implementing regulations and resulting program me is how to fulfil 
that requirement in a manner that addresses the associated risks, utilizes existing conformity 
assessment infrastructure in keeping with international obligations, and minimizes the government 
resources required.  The resulting conformity assess ment scheme uses a combination of approaches 
described in the Indicative List. Using the terminology from the List, the program me requires a 
Supplier's Declaration of Conformity (SDoC) , Use of Accreditation to Qualify Conformity Assessment 
Bodies  providing  data supporting that declaration, and achieving global scale by leveraging 
Cooperative (Voluntary) Arrangements between Domestic and Foreign Conformity Assessment 
Bodies . As to how each of those approaches is implemented , every children's product that is required 
to be third -party tested must follow this procedure by a CPSC -accepted laboratory for compliance. 
In order to be CPSC -accepted, the laboratory must be accredited pursuant to  ISO/IEC 17025  
(General requirements for the competence of testing and cal ibration laboratories ) by an accreditation 
body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition 
Arrangement  (ILAC MRA). The scope of accreditation must include the relevant testing 
methods/standards/regulati ons for the products to be tested. Laboratories meeting those 
prerequisites may apply to the CPSC using an on -line application process for recognition.  Based on 
the results of the third -party testing from a CPSC -accepted laboratory, the manufacturer can th en 
issue a Children's Product Certificate, which is the SDoC  under which the manufacturer attests to, 
and takes responsibility for, the conformity of the products placed into the market.  
1.3.  It was noted that utilizing the ILAC MRA  presents a number of advanta ges. First, the 
assessment of laboratories ' competence is left to the recognized experts in the accreditation bodies 
rather than duplicated by the regulator. Second, the approach allows for global participation through 
an existing mechanism of cooperation and peer evaluation. Finally, the system pr ovides several 
levels of accountability. Accredited laboratories are required to address complaints. If that process 
is not satisfactory, the next level of accountability is with the accreditation body. In turn, problems 
with an accreditation body can be r aised with the regional accreditation cooperation, and ILAC is at 
the top of that accountability pyramid.  Moreover, for purposes of the CPSC program, the use of ILAC 
was included in the implementing regulations as a required credential for laboratories to be accepted. 
In addition to those aspects of the voluntary accreditation infrastructure, the application and 
acceptance process for laboratories are critical elements of the program me. This provides the 
regulator with an additional level of authority, reta ining control of whether a laboratory is added to, 
or removed from, its list of accepted laboratories. The agreement with the laboratory also provides 
CPSC the right to investigate issues of concern. While t he intent and practice has not been to use 
these tools often, they allow the regulator to retain this authority over the conformity assessment 
bodies.  By way of conclusion, it was highlighted that the use of a combination of the three 
approaches from the Indicative List  has had an impact on: (i) the numb er and location of the 
participating conformity assessment bodies  (as of late 2019, 580 laboratories have been accepted 
from 47 economies ); and (ii) the effectiveness of the regulatory actions taken . According to CPSC 
data, the overall number of toy recall s has dropped from 178 in 2008 to 33 in 2014, and to 12 in 
2019.  While these results cannot be entirely attributed to the approaches taken  regarding conformity 
assessment , this example does highlight that  conformity assessment support s the achievement of 
overall regulatory objectives in a manner that, if successful, is integral , transparent, fit for purpose , 
and trade facilitative.7 
1.4.  Ms. Léa Contier de Freitas8 (Brazil ) explained the approach taken by Inmetro in Brazil with 
respect to the acceptance of confo rmity assessment (CA) results. Inmetro's regulatory scope focuses 
 
6 Standards Coordination Office at the United States National Institute of Standards and Technology  
7 This presentation used the following sources: (i) with respect to testing and certification requirements, 
https://www .cpsc.gov/Business --Manufacturing/Testing -Certification ; (ii) with respect to toy recall data,  
https://www.cpsc.gov/Safety -Education/Safety -Education -Centers/Toy -Recall -Statistics .  
8 INMETRO (Brazil), TBT Enquiry Point  G/TBT/GEN/288  
 
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  mostly on product safety in relation to consumer products falling within its purview (i.e. not covered 
by other regulatory agencies). INMETRO currently has 167 regulations with associated CA  schemes. 
With respect to the assessment of CA results, Brazil currently widely accepts foreign tests results in 
self-declaration and certifications schemes provided that the testing laboratory is accredited by an 
International Laboratory Accreditation Co -operation (ILAC) member and that tests are conducted 
according to requirements established in the regulation. Tests are conducted abroad for many 
products, including products for children, domestic appliances (electrical safety), and photovoltaic 
panels. W ith respect to certification schemes, Brazil accepts foreign CA results if the following 
conditions are met: (i) the foreign certification body is accredited by an International Accreditation 
Forum (IAF) Member and has a memorandum of understanding (MoU) w ith a national certification 
body; (ii) the MoU covers acceptance of assessments and testing and (iii) the national certification 
body issues the certificate, assuming full responsibility for the certification process. Moreover, 
foreign certification bodie s can coordinate certification processes in Brazil if they are accredited by 
INMETRO/Cgcre with respect to the relevant subject matter, they are legally established in the 
country, and all documentation is written in Portuguese. It was emphasized that the foreign 
certification body does not have to have all their installations in Brazil; instead the process can be 
conducted abroad and the office in Brazil can then issue the relevant certificate. In the near future, 
an increase in the acceptance of foreign C A results will be expected, considering that INMETRO's 
regulation will be revised to focus on essential requirements instead of prescriptive instructions.  
1.5.  Mr. Nikos Michailidis9 (European Union) presented examples of the acceptance of self-
declaration of conformity  (SDoC)  in the European Union in the fields of machinery, electrical and 
radio equipment. The European Union's legislation  on these fields consists  of the Low Voltage 
Directive 2014/35/EU (LVD), the Electromagnetic Compatibility Directive (EMCD), the Radio 
Equipm ent Directive 2014/53/EU (RED), and the Machinery Directive 2006/42/EC (MD). These 
Directives cover a broad range of products, such as household appliances, electric motors, and sound 
and television broadcast receivers. Th e examples presented do not concer n speciali zed equipment 
that is not considered "low risk" and is  therefore  subject to specific EU legislation ( e.g. aviation, 
maritime, toys, medical) . The four Directives at issue are total harmonization Directives, and thus, 
for the aspects they cover, n o additional requirements need to be complied with other than those 
set out in the Directives themselves. Under this legislation, m anufacturers need to  ensure that 
products are compliant with the applicable requirements . On this basis, they  shall establish  the 
technical documentation, establish and sign the declaration of conformity, and affix the CE marking. 
As a result, for the vast majority of products  falling within the scope of these Directives , there is no 
third-party approval/certification . Indeed, i nvolvement of notified bodies is required only in 
exceptional cases under the RED and MD.  Moreover, European harmoni zed standards mostly follow 
international standards  set out by the ISO and IEC. These standards are voluntary, their references 
are publishe d in the Official Journal of the EU , and, if they are applied, they provide a presumption 
of conformity with the corresponding requirements.  It was also highlighted that manufacturers 
established in a third -party state need to have a contact person in the EU in certain circumstances.  
1.6.  Turning to conformity assessment procedures, each Directive specifies the applicable 
conformity assessment procedure(s) that need to be followed. The involvement of a notified body is 
as follows: (a) under LVD, there is no inv olvement of a notified body; (b) under EMCD, it is 
discretionary to involve a notified body; (c) under RED, for safety and electromagnetic compatibility 
aspects, it is also discretionary  to involve a notified body ; for all other aspects, it is required to 
involve a notified body, only if harmoni zed standards have not been applied or do not exist ; 
(d) under MD, for the vast majority of products , there is  no involvement of a notified body  (it is 
discretionary) , except for in specific circumstances  involving h igh-risk products listed in the 
Directive; for those high -risk products, a notified body must be involved if harmoni zed standards 
covering all essential requirements have not been applied or do not exist . Pursuant to the legislation 
presented, the conformi ty assessment procedure that does not involve a notified body only obliges 
the manufacturer to ensure and declare on his/her sole responsibility that the equipment concerned 
satisfies the requirements of the  relevant  Directive.  For this purpose, the manufa cturer needs to  
establish the technical documentation , which must include  at least a d escription of the product , a 
list of harmoni zed standards or other specifications applied , and the r esults of  a risk assessment 
showing that the product is compliant . As a result, when this procedure is applicable, the product is 
placed on the market  without a  third-party involvement.  By way of conclusion, it was noted that 
SDoC, which had been utili zed in the Euro pean Union for over 35 years, had been an adequate 
 
9 Legal and Policy Expert, Engineering Industries, Directorate -General for Internal Market, Industry, 
Entrepreneurship and SMEs (GROW), European Commission  G/TBT/GEN/288  
 
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  procedure to protect the health and safety of consumers when applied in conjunction with a system 
of market surveillance.  It was also noted that SDoC r educes costs for manufacturers and time 
required other wise to place products on the market  and facilitates trade and the free circulation of 
these products on a globali zed market.  Finally, it was underlined that whether there is third -party 
certification or SDoC, post -market surveillance is anyway needed.  
1.7.  Ms. Melissa Torres10 (United States ) addressed the topic of conformity assessment for 
medical devices by describing the Medical Device Single Audit Program (MDSAP). MDSAP includes 
participation of five members11, two affiliate members12, and two observers13. MDSA P allows 
recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer 
that will satisfy the relevant requirements of the five participating regulatory authorities. Pursuant 
to this programme, the regulatory authorities  perform assessments of the AOs, which involves a 
formal recognition and monitoring process (using IMDRF Criteria and ISO/IEC 17021), as well as 
training and competency requirements for auditors. Moreover, under MDSAP, AOs perform audits of 
medical device manufacturers on behalf of the regulatory authorities on the basis of the MDSAP 
audit model. More specifically, after being assessed by the regulatory authorities, the AOs are 
responsible for the audit and for preparing an audit report. If any enforcement is required, the 
regulatory authorities must follow up with the medical device manufacturer. The assessment of the 
AO by the regulatory authorities focuses on various aspects of AO's operations, such as 
management, certification process and information and  competency management. In turn, MDSAP 
also establishes an assessment programme for recognizing AOs encompassing an initial assessment, 
a surveillance assessment, and a re -recognition assessment. With respect to the MDSAP audit model, 
it was noted that it includes 90 audit tasks covering all ISO 13485:2016 and regulatory 
requirements, as well as annexes specifying the audit of technical documentations and 
considerations relative to the audit of the controls of the sterility. By way of conclusion, while it t ook 
over 10 years to develop the MDSAP, its existence now provides a unified system that liberates 
resources from regulatory authorities and facilitates trade.  
1.8.  Mr. David Hanlon14 (IEC) presented a series of case studies related to the benefits of 
accepting IEC conformity assessment (CA) results. With a substantial overlap with the membership 
of the WTO, the IEC family of countries is comprised of 173 countries, of which 88 are members an d 
85 affiliates. The majority of new IEC Members come through the Affiliate Country Programme. By 
way of context, it was indicated that a generic national quality infrastructure (QI) should start by 
indicating the national objectives, such as human and ani mal safety, protection of the environment 
and national economic development. The structure of the QI is then put in place through a national 
policy framework. It was important that countries developed competency for developing national 
standards or create competency for the national adoption of international standards. Conformity 
assessment was about demonstrating that the requirements in the standards have been met. The 
policy framework may provide for both pre -market and post -market mechanisms. In this co ntext, 
the IEC global certification services are used to create value for the national QI. Indeed, especially 
for least developed and developing countries that have limited testing facilities or no testing facilities 
for electrotechnical products, relying on IEC certificates for imported goods is equivalent to having 
an international -level testing -laboratory, for free.  
1.9.  IEC has four global CA Systems, but the most relevant for this subject is the IECEE CB -scheme. 
The CB -scheme has more than 2 ,690 testing la boratories and 84 national certification bodies, in 54 
countries, and they test and certify to more than 3 ,000 IEC International Standards. This 
corresponds to more than 10 ,000 different product types. The IECEE CB -scheme has 54 member 
countries of which 2 7 are developing countries under the International Monetary Fund definition. All 
of these countries participate in the IECEE CB -scheme by having testing laboratories and certification 
bodies, and by recognizing and accepting the certificates issued from wi thin the CB -scheme. By 
recognizing these certificates, the need for duplicating tests is avoided and trade is facilitated. It 
was noted that several countries use the IECEE CB -scheme services for the benefit of their national 
QI. For example, Côte d’Ivoire  has adopted 342 IEC International Standards as national standards. 
Other countries that have adopted IEC international Standards include Ethiopia (251 IEC standards 
 
10 Associate Director for Intern ational Affairs, Office of the Center Director, Center for Devices and 
Radiological Health, United States Food and Drug Administration  
11 Australia, Brazil, Canada, Japan, US  
12 Argentina and Korea  
13 EU and WHO  
14 IEC Conformity Assessment Board (CAB) Secretary  G/TBT/GEN/288  
 
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  adopted), Senegal (67 IEC standards adopted), and Togo (568 IEC standards adopted). While none 
of these countries have testing laboratories with competencies for all of the imported products at 
issue, accepting the IEC certificates is like having an international -level testing -laboratory, for free. 
It was also noted that when goods arrive at th e border, they are accompanied by shipping 
documents, which include an IECEE CB -scheme certificate or test report. It is possible to determine 
that the mentioned certificate or test report is legitimate by authenticating it on the IECEE online 
certificate system. For the four case studies at hand, the verification of whether the certificates or 
test reports accompanying the imported products are authentic is normally carried out by the 
national certification bodies. In sum, adopting IEC International Standa rds as national standards, 
and then recognizing IEC certificates is a very efficient and inexpensive way to develop the national 
QI and achieving the national objectives for product safety.  
COMMENT BY MODERATOR  
1.10.   On a personal note, the Moderator  made the fo llowing remarks.  
1.11.   Finally, let me make a few personal remarks. I think that the presentations and discussions 
shed light on some interesting case studies on the acceptance of conformity assessment results. 
Examples in the toys, medical devices, machinery a nd electrical and electronic product sectors 
illustrated how Members rely on various approaches in the TBT Committee's "Indicative List" to 
accept conformity assessment results from other Members. The importance of using international 
guides and recommenda tions for conformity assessment, and benefits of relying on the ILAC MRA, 
were both emphasized, as was the use of supplier's declaration of conformity in conjunction with a 
system of market surveillance. We also heard about the range of challenges that "ce rtificates of free 
sale" create for both exporters and regulators. I believe that that discussion shows the need for 
sector specific solutions for the acceptance of conformity assessment results in line with the 
"Indicative List", and I look forward to fur ther fruitful discussion in the Committee on these matters.  
  G/TBT/GEN/288  
 
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  ANNEX  
 
THEMATIC SESSION ON CONFORMITY ASSESSMEN T PROCEDURES:   
CASE STUDIES OF PRAC TICAL EXAMPLES OF HO W MEMBERS ARRIVE AT THE 
ACCEPTANCE OF CONFORMITY ASSESSMEN T RESULTS  
25 FEBRUARY 2020 , 15:00 -18:001 
Programme2 
At the Eighth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction 
with its regular meetings during 2019 to 2021, with a view to further deepening the Committee's 
exchange of experiences on specific topics, and to hold a session on conformity assessment 
procedures (CAP) in February  2020 with a  focus on: Certificates of free sale ; and, Case studies of 
practical examples of how Members arrive at the accept ance of conformity assessment results .3 
 
_______________  
 
 
This thematic session  will be  moderated by  Mr. Anatoly Chaplin (Russian Federation) . 
 
Guiding questions:  
• What practical examples exist of how Members arrive at the acceptance of conformity 
assessment results?  
• How are Members using the approaches mentioned in the Committee's "Indicative List" to 
facilitate acceptance of conformity assessment results?  
 
 
Panel  
a. South Africa : Certificates of Free Sale - An overview and challenges faced  by Regulators 
and Exporters , Mr. Kissinger Ntsako Nkuna , Department of Trade and Industry . 
b. United States : Impacts of leveraging international accreditation infrastructure in testing 
of children 's products , Mr. Warren Merkel, Director, Standards Services Division, National 
Institute of Standards and Technology (NIST) . 
c. Brazil:  Acceptance of conformity assessment results: examples for consumer products 
regulated by Brazil's National Institute of Metrology Sta ndardization and Industrial Quality 
(Inmetro) , Mr. Marcos André Borges, Inmetro . 
d. European Union : Examples of the acceptance of self -declaration of conformity in the 
European Union in the fields of machinery, electrical and radio equipment , Mr. Nikos 
Michai lidis, Legal and Policy Expert, Engineering Industries, Directorate -General for 
Internal Market, Industry, Entrepreneurship and SMEs (GROW), European Commission.  
e. United States:  Conformity assessment program for medical devices: The Medical Device 
Single Audit Program (MDSAP) , Ms. Melissa Torres, Associate Director for International 
Affairs, Office of the Center Director, Center for Devices and Radiological Health, United 
States Food and Drug Administration.  
f. International Electrotechnical Commission  (IEC): Case studies on countries using 
and benefiting from the IEC global conformity assessment services , David Hanlon,  IEC 
Conformity Assessment Board (CAB) Secretary . 
__________  
 
1 This thematic session may start earlier, directly following the thematic session on GRP.  
2 The draft programme is contained in JOB/TBT/355/Rev.1 . 
3 G/TBT/41 , para. 8.2.a.iv, footnote 301; JOB/TBT/350 .