G/TBT/GEN/257  
 
14 March  2019 
(19-1607) Page: 1/7 
Committee on Technical Barriers to Trade    
 
THEMATIC SESSION ON CONFORMITY ASSESSMEN T PROCEDURES1 
5 MARCH 2019 , 15:00 -18:00  
Moderator 's Report2  
This Report  was delivered by the Moderator of this Thematic Session of the WTO TBT Committee at 
the meeting of  6-7 March 2019 .  
 
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At the Eighth Triennial Review, Members  agreed to continue to hold thematic session s in conjunction 
with regular meeting s of the Committee . It was agreed that a session would be held on conformity 
assessment procedures  (CAP) in March 2019 with a focus on : post-market controls (e.g. market 
surveillance) and other pre -market controls ; and risk assessment .3 The p resentations  summarized 
below  will be made  available through  the WTO website.4  
Panel 1  
1.  Mrs. Beverly Kohen (United States)  emphasized the role of the Consumer Product Safety 
Commission (CPSC) in promoting product safety and injury prevention, through the enforcement o f 
product safety legislation. The CPSC Field Office engages in various activities, including: surveillance 
in retail stores to ensure that banned or recalled products are not on shelves; inspection of 
companies as part of regulatory enforcement programs; i nspection as a follow up to a complaint or 
surveillance; inspection of companies destroying recalled products; and, investigations based on 
consumer complaints involving products. These activities cover products subject to specific 
regulations, such as toy s, and others which are not, like a coffee maker, that should not pose a 
substantial product hazard. CPSC labs can test products according to regulations and, in the absence 
of specific regulations, the lab may undertake analysis to determine the cause of the hazard if one 
exists. In addition, CPSC conducts market surveillance in respect of voluntary standards. CPSC also 
undertakes investigations of fatalities that may have resulted from a product safety problem, as well 
as import surveillance at ports. In case a violation of regulations is found, this is referred for 
compliance processes at which point the level of the hazard, and any corrective action, is 
determined. For example, if there is a labelling issue, this can be addressed with the company to 
ensure that all inventory is relabeled and any further imports or manufacturing follow the correct 
labelling. In terms of inspections of companies, specific procedures and information are gathered at 
the inspection visit, including collection of samples; an in spection report is completed and used to 
determine if any corrective actions are necessary to address the problems .  
2.  Mr. HAO Xin  (China ) described the recent reforms of the China Compulsory Certification (CCC) 
system, the most important conformity assessment system in China. A major reform was undertaken 
since 2017, which included reducing, streamlining and optimizing the catalogue of produ cts subject 
to the scheme, the implementation of science -based classification, simplification of processes and 
procedures, and promotion of fair competition. The reduction of the product scope was undertaken 
                                                
1 The list of speakers is contained in JOB/TBT/ 298/Rev.2 . 
2 Mrs. Elisa Olmeda (Mexico) . This Report is provided on the Moderator 's own responsibility.  
3 G/TBT/41 , para. 8.2.a.iv, footnote 295; JOB/TBT/273/Rev.2 , para. 1.3.  
4 https://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm  G/TBT/GEN/257  
 
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  based on risk assessment, which cut 31 low -risk products from the catalogue, including computer 
game machines and motorcycle engines , etc. The science -based classification introduced two 
facilitated approaches for different product categories: self -declaration with testing at a self -
designated lab (12 p roduct categories); and self-declaration with testing at a government -
designated lab (20 product categories). With respect to simplification of processes and procedures, 
the aim was to achieve one factory inspection covering certificates of multiple certif ication bodies, 
certification prior to on -site inspection, recognition of commitments by certified undertakings, and 
promotion of internet -based certification. Fair competition was promoted through increasing the 
number of implementing agencies, and priori tizing organizations providing integrated testing and 
certification services, including six foreign -owned labs. A recent reform trend is the replacement of 
industrial product production licen ces with CCC for certain products, such as helmets for motorcycle  
passengers or electric blankets, while additional products are also undergoing this transition. Further 
follow -up reform measures include additional streamlining and optimizing of the catalogue to reduce 
product coverage, expanding the scope of self -declaration, further optimizing certification 
procedures, and reducing the certification unit and number of certificates.5  
3.  Mr. Christophe Roeland  (European Union ) explained that market surveillance is crucial for the 
enforcement of product legislation, and the  protection of consumers and users with respect to health, 
safety, the environment, energy efficiency and other public interests, as well as eliminating unfair 
competition. Market surveillance complements the choice of conformity assessment procedures by 
looking at the entire lifecycle of the product, including after it has been placed on the market, and 
in striking a balance between pre - and post -market controls to take account of the risk to be 
addressed and the product market in question. Market surveill ance is crucial to enable regulators to 
choose more flexible conformity assessment procedures to facilitate trade. The EU framework for 
market surveillance of non -food products is set out in three tiers of the legislation, the main tier 
being Regulation EC  No 765/2008. This regulation provides a common framework and set of 
obligations to ensure effective market surveillance across the EU. It stipulates that EU member 
States are responsible for enforcement of EU product legislation. There are more than 500 d ifferent 
member State Market Surveillance Authorities (MSAs) across the EU, and cooperation between them 
is vital for the effective functioning of the single market.  
4.  The main obligation on an EU member State is the requirement to act against any product th at 
could endanger health or safety, or otherwise does not comply with harmonized EU product safety 
legislation. In addition, there are requirements on member States with respect to administrative 
organization, such as providing necessary resources and infr astructures to perform market 
surveillance, or establishing complaint procedures and monitoring of product accidents. EU member 
States are required to perform checks on an appropriate scale on products, which include 
documentary (declaration of conformity,  technical documentation), physical, and laboratory checks. 
They must also ensure that products presenting a serious risk are recalled or withdrawn, based on 
a general EU risk assessment methodology. There is a strong preference for early dialogue with 
economic operators to correct problems, rather than restrictive measures, and procedural rights for 
economic operators are guaranteed. Border control and customs authorities play an important role, 
and checks are undertaken based on risk assessment. There are  several tools at the EU level to 
exchange information and promote cooperation between MSAs, such as RAPEX (Rapid alert system 
for products presenting a serious risk) or ICSMS (Technical database for exchange of information on 
controls, tests and results).  An evaluation of the EU framework was undertaken during 2016 -2017, 
which found that there were still too many non -compliant products on the EU market. On this basis, 
the European Commission made a proposal to upgrade its market surveillance system, includ ing to 
promote cooperation with economic operators, and to provide stronger enforcement tools 
particularly to address online sales. This legislative process is still in process, and expected to be 
formally adopted by the European Parliament and Council in April 2019. He highlighted several key 
elements of market surveillance: a clear level framework for evidence - and risk -based controls, 
proportionality and due process; supporting economic operators to comply; strategic planning and 
adequate resources; and,  core powers and appropriate sanction mechanisms.6  
5.  Mr. Tanguy Larher (European Union ) explained that market surveillance is centralized in 
France, and that there is cooperation between 20 French MSAs (including Customs) covering 
different product areas in line with the EU harmonized legislation. Product non -conformity creates 
problems not j ust in terms of danger to consumers, but also for economic operators and business 
                                                
5 The full presentation is contained in document RD/TBT/263 . 
6 The full presentation is contained in document RD/TBT/260 . G/TBT/GEN/257  
 
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  transactions. Market surveillance generally occurs before the product has been purchased by the 
consumer, however, in some cases it takes place on products already in service  or use (e.g. for legal 
metrology). Responsibility for market surveillance is shared between economic operators, importers 
and distributors, and MSAs. Economic operators need to identify and manage risks, provide 
information to consumers, take corrective a ctions in case of issues, and cooperate with MSAs. 
Importers and distributors must ensure product traceability in case of recall, inform manufacturers 
of problems, and likewise cooperate with MSAs, especially if the entity is not based in the EU. MSAs 
identify emerging risks, enforce product requirements, manage notifications of dangerous products, 
and cooperate with other EU member State authorities, such as on joint market surveillance actions. 
With respect to investigations, a choice is made on the produ cts to be inspected based on intrinsic 
product risk and the risk of the economic operator. Inspection is undertaken on all actors along the 
supply chain. During an inspection, the product is observed and handled, there are documentary 
checks, physical chec ks, and sampling for laboratory checks, as needed. MSAs have the power to 
seize a product, consign products if there are concerns, apply injunctions or administrative 
measures, or suspend the placing on the market of a product category. French Customs is o ne 
important French MSA, which undertakes a range of investigations. The DGCCRF (Direction générale 
de la concurrence, de la consommation et de la répression des frauds) is the most important French 
MSA, with 3,000 agents on the market, conducting national  investigations in collaboration with other 
MSAs in different sectors.7  
Panel 2  
6.  Mr. Pang Te LIN (the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu ) 
explained how risk assessment was conducted throughout the lifecycle of medicinal products. In 
terms of the risks related to the use of such products, safety and efficacy are intrinsic, while quality 
is extrinsic, and the balance between benefit and risk ( side effects) needs to be struck in the context 
of continuous assessment throughout the lifecycle. Based on International Council for Harmonisation 
of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulation, there are several 
steps in the  regulatory management process, including pre -market approvals, from discovery to 
marketing. In this context, application of international guidance helps to reduce trade barriers, such 
as Pharmaceutical Inspection Co -operation Scheme (PIC/S) on good manufa cturing practices (GMP). 
As an example, he explained how the benefit -risk balance for the drug Thalidomide shifted overtime. 
It was initially approved for alleviating nausea and morning sickness in the 1950s, then withdrawn 
in the 1960s due to risk of phoc omelia, and later found to have some benefits for treatment of 
certain conditions when risk of exposure to pregnant women is minimized. As a second example, he 
mentioned that Carbamazepine was an antiepileptic drug marketed in the 1960s, but found to cause  
serious side effects and drug injury. More recently, the risks and benefits of Carbamazepine therapy 
for certain populations were managed through revisions to mandatory labelling requirements, which 
has led to a decline in the cases of drug injury. The FD A surveillance programme includes both 
quality and safety surveillance, with both passive and active aspects. Global drug information 
monitoring on quality and safety provides important tools for risk management.8  
7.  Mr. Ravi Bharwani  (United States ) describ ed the role of the US Food and Drug Administration 
(FDA) in ensuring the safety and efficacy of a range of products sold in the US, including drugs, 
medical devices, cosmetics, tobacco, and food carrying nutritional facts labels. The US Customs and 
Border Protection (CBP) operates an electronic single window for filing information required for 
import, and through this system the FDA uses a real -time risk analytic tool to assess imports entering 
the US: PREDICT. He explained that PREDICT electronically scree ns and assigns scores to 
consignments of regulated products bound for the US. Consignments with low scores automatically 
enter the US, while those with higher scores are subject to further examination and testing by border 
inspectors. This allows FDA to fo cus its limited resources on higher -risk consignments, and facilitate 
trade for low -risk consignments, considering the growing volume of the imports under the purview 
of the FDA. PREDICT verifies whether the consignment fulfils applicable regulatory requir ements, 
uses automated data mining and pattern discovery, as well as open source intelligence. Risk factors 
considered by PREDICT include the inherent product risk, whether previous shipments were found 
to violate FDA requirements, whether a manufacturer h as a similar product that was found to violate 
                                                
7 The full presentation is contained in document RD/TBT/ 265. 
8 The full presentation is contained in document RD/TBT/259 . G/TBT/GEN/257  
 
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  FDA requirements (or a product from the same country), the results of inspections of products on 
the US market, and the accuracy of import and registration documents.9  
8.  Ms. Kuniko Ishigami (Japan ) explained th at Japan's consumer product safety regulations 
specify some products that are likely to endanger life or health (including electrical appliances and 
materials, town gas equipment, LPG equipment, an d general consumer products).  These include 
both pre -market  regulation and post -market measures. Conformity assessment procedures under 
four regulations for product safety have introduced the approaches listed in the TBT Committee 
"Indicative list", namely, self -declaration of conformity or third -party conformity assessment (based 
on registration of foreign and domestic conformity assessment bodies, recognition of voluntary 
arrangements, and government -government MRAs). Post -market measures used by regulators 
include a sampling test, on -site inspection, the Serious  Product Accident Reporting and Disclosure 
Scheme, and, if necessary, orders for product recalls and withdrawals from the market. Under the 
Serious Product Accident Reporting and Disclosure Scheme, any manufacturer or importer must 
report serious accidents  involving their products (e.g. death, serious/fatal injury, fire, physical 
disability) to the Government within ten days; this information is published by the Consumer Affairs 
Agency, and made available promptly. The Ministry of Economy, Trade and Industr y (METI) is 
responsible for the corrective measures that suppliers must undertake based on investigation 
results. The National Institute of Technology and Evaluation (NITE) investigates and reports on the 
cause of accidents, including through demonstration  experiments. In addition, NITE collects 
information about non -serious product accidents, and reports publicly on these. Japan experienced 
a series of fatal accidents caused by defective products in the early 2000s, in response to which the 
Accident Report  Disclosure System was established. The accident information collected and the 
results of its analysis are used as necessary for improving regulations (amending technical 
requirements, specifying products, deregulation etc.). This can be understood as an a ction stage in 
the plan -do-check -action cycle. The number of serious product accidents annually declined from 
around 1,400 in 2008, to 900 in 2017. Products purchased through online markets, however, pose 
new policy challenges.10  
9.  Ms. Jennifer Evans (CEO, National Association of Testing Authorities, Australia) described 
changes in supply chains that necessitated changes in conformity assessment infrastructure in 
Australia. She began by emphasizing some key principles of supply chains that are importan t to 
business and consumer confidence: transparency (e.g. that answers can rapidly be obtained on 
conformity of products), fairness, and integrity. Until the 1980s, the Australian economy was subject 
to high levels of protection, and the domestic manufactu ring sector was significant. Importers were 
hit twice by tariffs and burdensome conformity assessment procedures. Supply chains were simple 
and linear. Today, there have been significant changes in Australia's economy, and supply chains 
are transnational, dynamic and complex. In the context of these modern supply chains, it may be 
difficult to trace the source of fault behind non -conforming goods, and there also may be a 
corresponding lack of accountability. Credence attributes of products must be taken on trust by 
consumers, and this is the focus of third -party conformity assessment and testing, with the 
conformity assessment body acting as the 'quality proxy ' for consumers. She provided the example 
of non -conforming construction materials in Australia, whi ch raised questions about conformity 
assessment and regulatory regimes and raised concerns about fraudulent test reports and 
certifications. Public trust in imported products is low. There has also been a shift in regulatory 
practice in this sector away fr om prescriptive standards towards performance resulting in a greater 
role for the private sector (e.g. engineering consultants and building surveyors). As a positive 
example, she described incentives provided by the Australian federal government energy eff iciency 
program for electrical equipment and appliances: the "E3 Program". This program uses more flexible 
pre-market measures, and instead places emphasis on post -market "check -testing" at accredited 
laboratories, while penalties discourage suppliers from  exaggerating claims.11 
10.  Ms. Karen Grunstra  (Underwriters Laboratories, United States) emphasized that one size does 
not fit all when it comes to conformity assessment, but that the private sector can and should be an 
important partner in aspects of market s urveillance. With respect to the relationship between 
conformity assessment methods and market surveillance, there are varying models shaped by risk, 
but in all cases conformity assessment needs to be paired with effective market surveillance efforts, 
and the responsibility for compliance lies with all stakeholders. The choice of conformity assessment 
                                                
9 The full presentation is contained in document RD/TBT/272 . 
10 The full presentation is contained in document RD/TBT/264 . 
11 The full presentation is contained in document RD/TBT/273 . G/TBT/GEN/257  
 
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  procedure has implications for how the burden of market surveillance will fall on different 
stakeholders (e.g. supplier's declaration of conformity places bur den on government, third party on 
the certification body). UL Mark Schemes include post -market surveillance requirements, and UL 
conducts various market surveillance activities based on trends and compliance data to protect and 
safeguard the Mark. She high lighted two examples of UL partnering with the US Government on 
conformity assessment schemes and marks, including market surveillance. First, the Environmental 
Protection Agency (EPA) Energy Star, under which the US Government serves as the scheme and 
mark owner and where post -market verific ation is administered by the 23  recognized certification 
bodies (including UL). Second, the Occupational Safety and Health Administration (OSHA) Nationally 
Recognized Testing Laboratory (NRTL) Program, under which the U S Government is the scheme 
owner using private marks.12 
11.  On a personal note, the Moderator  made the following remarks.  
12.  On Tuesday afternoon we had a very rich exchange on market surveillance and risk assessment. 
There were several key points that I noted do wn from the presentations:  
a. There needs to be a balance between pre - and post -market measures . Conformity 
assessment procedures are complemented and made effective through market 
surveillance. The choice of conformity assessment procedures has implications for the 
approach to market surveillance, and how the burdens of market surveillance will be 
distributed amongst different actors.  
b. Cooperation  is vital for effective market surveillance – between market surveillance 
authorities, economic operators, and the private sector . 
c. Consumers  play a key role, whether in terms of reporting accidents or assisting 
investigations. Disclosing information about accidents to consumers and the public is an 
important tool to encourage better compliance.  
d. How to best use limited resources  to address the highest risk situations. Whether a 
consignment or product should be subject to additional pre - or post -market controls 
depends on things like the inherent risk of the product and the manufacturer's track 
record.  
e. Technology  is makin g an important contribution to risk assessment and market 
surveillance, and helping to make trade flow more smoothly. Some Members have 
electronic risk assessment tools that they apply at customs to identify shipments for 
further examination and testing, w hile others use technology to quickly share information 
about product accidents and alerts in support of market surveillance . 
f. Streamlining  conformity assessment systems and market surveillance approaches on the 
basis of risk assessment can help to facilita te trade. More generally, improving the 
coordination and functioning of the quality infrastructure is an important aspect of these 
efforts, within which market surveillance is one key pillar.  
g. There are new policy challenges , such as online shopping, and ma rket surveillance and 
risk assessment need to adapt . 
13.  Finally, we have a lot of work ahead of us – our discussion on Tuesday afternoon considered 
just one aspect of conformity assessment, that is on the particular aspect of post -market controls 
(e.g. market  surveillance) and other pre -market controls; and risk assessment. We now need to 
think about how to merge this into our Committee work – and how this will feed into our work to 
develop guidelines in the area of conformity assessment.  
14.  So, as was said by T hembi before me in the area of GRP, the Committee might wish to consider 
ways to bring this work forward and I would encourage the Chair and the Committee more broadly 
to consider follow -up.  
                                                
12 The full presentation is contained in document RD/TBT/262 . G/TBT/GEN/257  
 
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  15.  I welcome any comments from Members on this oral report, of cour se – please feel free to jump 
in with any additions if you think I missed something important. Let me again thank Members for 
their engagement and for the experience that has been shared.  
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 G/TBT/GEN/257  
 
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  ANNEX  
 
THEMATIC SESSION ON CONFORMITY ASSESSMEN T PROCEDURES  
5 MARCH 2019 , 15:00 -18:00  
Final Programme  
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 t he Committee's 
exchange of experiences on specific topics, and to hold a session on conformity assessment 
procedures  (CAP) in March 2019 with a focus on : post market controls (e.g. market surveillance) 
and other pre -market controls ; and risk assessment .1  
 
_______________  
 
 
This thematic session  was moderated by:  Mrs. Elisa Olmeda  (Mexico ) 
 
Panel 1  
a. United States : Post Market Surveillance for Consumer Product Safety in the United 
States , Beverly Kohen, Director of Field Investigations, U.S. Consumer Product Safety 
Commission (via video conference).  
b. China : Introduction to the Latest Development of the Reform of the China Compulsory 
Certification System , Mr. HAO Xin, State Administration for Market Regulation.  
c. European Union:  Enforcement of Legislation o n Produ cts: the Market Surveillance 
Framework in t he European Union , Mr. Christophe Roeland, Policy Officer, Directorate -
General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission.  
d. European Union : Enforce ment of legislation on products: French organization for market 
surveillance , Mr.  Tanguy Larher, Head of the Office for Products Regulation, French 
Ministry for Economy and Finance.  
Panel 2  
e. Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu : Risk 
Assessment through the Life Cycle of Medicinal Products , Mr. Pang Te LIN, Associate 
Researcher, Food and Drug Administration, Ministry of Health and Welfare . 
f. United States: PREDICT: A risk -based tool for regulated products , Ravi Bharwani, 
Advisor, Globa l Regulatory Policy, U.S. Food and Drug Administration.  
g. Japan: Product Accident Information , Ms. Kuniko Ishigami, Deputy Director, Office for 
Economic Partnership for Standards and Conformity Assessment, Ministry of Economy, 
Trade and Industry . 
h. Australia : Challenges to conformity assessment models of changing supply chains – some 
Australian experiences , Ms Jennifer Evans, Chief Executive Officer, National Association of 
Testing Authorities (NATA)  
i. United States : UL – Trusted Partner in Market Surveillance , Karen G runstra, Global 
Government Affairs Senior Specialist, Underwriters Laboratories  
__________  
                                                
1 G/TBT/41 , para. 8.2.a.iv, footnote 295; JOB/TBT/273/Rev.2 , para. 1.3.