G/TBT/W/530  
 
29 May 2018  
(18-3226) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
PROPOSAL ON A HOLIST IC APPROACH TO RISK ASSESSMENT  
EIGHTH TRIENNIAL REV IEW 
Submission from the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
The following submission, dated 28 May 2018, is being circulated at the request of the delegation 
of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu . 
 
 
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On the occasion of the Eighth Triennial Review under Article 15.4 of the Agreement on Technical 
Barriers to Trade, the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would 
like to propose that a holistic approach be taken to discuss risk assessment.  
1  BACKGROUND  
1.1.  Article 2.2  of the TBT Agreement requires Members to ensure that technical regulations are 
not more trade -restrictive than necessary to fulfil a legitimate objective, taking account of the 
risks non -fulfilment would create.  The last sentence of Article 2.2 specifies that risk assessment 
should consider, inter alia, the availabili ty of scientific and technical information, related processing 
technology or intended end -uses of products. Further, Article 5.1.2 of the TBT Agreement also 
stipulates that conformity assessment procedures shall not be strict er or be applied more strictly 
than is necessary to give the importing Member adequate confidence that products conform to the 
applicable technical regulations or standards, taking account of the risks non -conformity would 
create.  Risk assessment plays an important role in determining a n appropriate and necessary level 
of requirements in technical regulations that adequately address legitimate policy concerns while 
not creating unnecessary restrictions on trade.  It is also a critical factor in the design and 
implementation of sound and e ffective conformity assessment procedures that are consistent with 
the TBT Agreement.  
1.2.  Standards, being one of the categories of measures covered by the TBT Agreement, are 
considered of equal importance as technical regulations. The importance of standards  was 
emphasized at the thematic session held on 14 June 2016, where Members shared their 
experiences on the methods of referencing standards in regulations. Just as noted in the 
moderator 's report (G/TBT/GEN/199), standards can be developed to support regu lation and 
policy; standards need to evolve to remain relevant for regulators; and standards that attain a 
balance between addressing objectives, such as health and environment, and facilitating trade can 
serve as tools for the improvement of laws and regu lations. Though risk assessment is not 
explicitly mentioned in standards -related provisions of the TBT Agreement, its use is envisaged in 
order to fulfill the  obligation stated in Paragraph E of Annex 3 to the TBT Agreement that 
standards are not prepared,  adopted or applied with a view to, or with the effect of, creating 
unnecessary obstacles to international trade.  G/TBT/W/530  
 
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  2  PREVIOUS WORK  ON THE CONTRIBUTI ON OF RISK ASSESSMEN T 
2.1.  In the last Triennial Review of the TBT Agreement in 2015 (G/TBT/37), Members shared thei r 
experiences in risk assessment under the theme of approaches to conformity assessment. 
Experiences were also shared by Members for the role of risk assessment as part of the effort on 
observing the Six Principles of the Code of Good Practices. Further, o ne Member proposed 
(G/TBT/W/418 ) that as risk assessment forms an important part of the operation of the Regulatory 
Impact Assessment (RIA), experiences -sharing on how regulators undertake risk assessment 
should be considered.  Based on similar consideratio n, we also proposed to hold a thematic 
workshop on risk assessment (JOB/TBT/211 ), which was subsequently held in June 2017. The 
moderator 's report (G/TBT/GEN/226) summarized quite well that risk assessment was a multi -
faceted topic, with relevance to diffe rent aspects of the work of the TBT Committee .  
3  STANDARDS AND RISK A SSESSMENT  
3.1.  Previous discussions at the Committee mainly focused on the use of risk assessment in 
support of choosing appropriate level of regulatory requirements and conformity assessment 
procedures. As it is a common practice for Members to reference and integrate standards as part 
of both technical regulations and conformity  assessment  procedures, risk assessment in standard -
setting process bears similar weighting insofar as the improvemen t of the quality and 
appropriateness of technical regulations and conformity  assessment  procedures are concerned. It 
is especially relevant if the standardi zing body and regulator is integrated and/or coordinated by 
the same authority; the best practices i n ensuring consistency in risk assessment are equally 
worth noting.  
3.2.  A relevant question concerns with the incorporation of international standards in national 
standards or technical regulations. Both Article 2.4 and Paragraph F of Annex 3 of the TBT 
Agree ment clearly state that where relevant international standards exist or their completion is 
imminent, they, or the relevant part of them, shall be used as a basis for technical regulations and 
standards, except when such international standards or relevant  parts would be ineffective or 
inappropriate, for instance, because of an insufficient level of protection or fundamental climatic or 
geographical factors or fundamental technological problems. The role risk assessment plays in 
facilitating Members to deci de and demonstrate whether relevant international standards are 
effective or appropriate  is a key policy issue as well.  
4  A HOLISTIC DISCUSSIO N ON RISK ASSESSMENT  
4.1.  Having noted the relevance of risk assessment to all three categories of measures, we are of 
the view that discussions at the Committee can be devoted in a structured manner so that a 
common understanding can be gradually built up among Members on what ris k assessment is (e.g. 
risks associated with different products, risk assessment vs risk management), how it is performed 
(e.g. methods for assessing risks), when and where it is undertaken (e.g. necessity for conducting 
risk assessments for standards, tech nical regulations and conformity assessment procedures 
respectively). We believe that Members will benefit from experiences shared by others to apply 
risk assessment more effectively and build the required capacity to implement the TBT Agreement . 
Hopefully , trade concerns in relation to risks will also be addressed efficiently as a result of such 
common understanding.  
5  PROPOSAL  
5.1.  Risk assessment is a cross -cutting issue under the TBT Agreement. In addition to its 
application to the choice of appropriate confor mity assessment  procedures, the operation of border 
inspection and market surveillance, as identified  by the European Union, it also takes a critical role 
in making decisions on the need for technical regulations and in setting standards that are to be 
referenced in regulations. In the context of the Eighth Triennial Review and to keep the 
momentum of discussions on risk assessment, the Separate Customs Territory of Taiwan, Penghu, 
Kinmen and Matsu proposes that efforts be devoted to present a general frame work of risk 
assessment prior to moving into specific areas to facilitate Members ' general understanding of the 
issue. Therefore,  the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu proposes 
that thematic sessions be held to invite experienc e sharing by Members on the following possible 
topics.  G/TBT/W/530  
 
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  5.2.  An introductory session  
1. Overview of risk assessment: categorisation of risks and methods of assessing risks.  
2. The framework and operation models of TBT -related risk assessment regime, resources 
required and challenges.  
5.3.  A session on the use of risk assessment in specific areas , for instance:  
1. The c hoice and design of conformity assessment.  
2. The role and practice of risk assessment in standards development (including 
international standards, regional  standards or national standards)  and technical 
regulations , in particular where standards are referenced in regulations.  
 
 
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