G/TBT/W/462  
 
9 March 2018  
(18-1460) Page: 1/5 
Committee on Technical Barriers to Trade  Original: English  
 
 APPROACHES TO CONFOR MITY ASSESSMENT  
EIGHTH TRIENNIAL REV IEW 
Submission from the European Union  
The following submission, dated 9 March 2018 , is being circulated at the request of the delegation 
of the European Union . 
 
_______________  
 
 
The European Union  welcomes the opportunity to participate in the Eighth Triennial Review under 
Article 15.4 of the Agreement on Technical Barriers to Trade (TBT Agreement). The European 
Union puts forward the following proposal on the choice and design of conformity assess ment 
procedures (approaches to conformity assessment) with the view to further work of the Committee 
aimed at improving the understanding and enhancing the implementation of the relevant 
provisions of the TBT Agreement.  
1  BACKGROUND  
1.1.  The TBT Agreement defines  conformity assessment procedures as any procedure used, 
directly or indirectly, to determine that relevant requirements in technical regulations or standards 
are fulfilled. According to the relevant explanatory note, conformity assessment procedures 
include, inter alia, procedures for sampling, testing and inspection; evaluation, verification and 
assurance of conformity; registration, accreditation and approval as well as their combinations .1 
1.2.  Conformity assessment serves very important purposes: it helps r egulators to achieve public 
policy objectives, such as the protection of health, safety and environment; it gives consumers 
confidence that products purchased are licit and safe; it enables manufacturers to establish 
compliance of their products with appli cable requirements in order to place them on the market; it 
increases trust along the value chain.  
1.3.  At the same time, conformity assessment activities entail costs, especially for businesses. An 
OECD study found that costs "may stem from diverging assessmen t methods such as diverging 
laboratory testing, certification, inspection or audit procedures, resulting in their unnecessary 
duplication causing an additional time delays as well as the need for staff, capital, inputs or fees". 
This study emphasised that "conformity assessment systems can add costs for producers and 
traders as tests and certificates established at home may need to be duplicated in the destination 
market irrespective of substantial differences in the specification of products or assessment 
methods" .2 
1.4.  Business experiences seem to confirm that conformity assessment is one of the most 
significant categories of non -tariff measures (NTMs). Based on business surveys in developing 
countries, the International Trade Centre (ITC) found that among the  types of "burdensome" NTMs 
applied by importing countries to exporters, measures concerning conformity assessment rank first 
                                                
1 Annex 1 of the TBT Agreement.  
2 2016 OECD Study, International regulatory cooperation and trade, page s 17 and 18.  G/TBT/W/462  
 
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  for agricultural products (48%) and second for non -agricultural products (23%)3. Businesses in 
developed countries appear to face similar challenges; an ITC survey of EU exporters show that 
conformity assessment rank first (32%) among the types of problems faced in connection with 
"burdensome" regulations .4 
1.5.  Finally, conformity assessment is at the origin of some 40% of the specific t rade concerns 
(STCs) discussed in the TBT Committee. In addition, over the period 2010 -2016, the share of new 
STCs related to conformity assessment procedures exceeds the share of notifications of conformity 
assessment procedures. This suggests that notifi ed measures establishing conformity assessment 
procedures are more likely to constitute a concern for Members than technical regulations alone .5 
2  APPROACHES TO CONFOR MITY ASSESSMENT: STR IKING THE RIGHT BALA NCE 
2.1  Relevant provisions of the TBT Agreement  
2.1.  Articles 5.1 and 5.1.2 of the TBT Agreement lay down an obligation on Members to ensure 
that, in cases where a positive assurance of conformity with technical regulations or standards is 
required, conformity assessment procedures are not prepared, adopted or app lied with a view to 
or with the effect of creating unnecessary obstacles to international trade. Pursuant to Article 
5.1.2, conformity assessment procedures shall not be stricter or applied more strictly than is 
necessary to give the importing Member adequ ate confidence that products conform with the 
applicable technical regulations or standards, taking account of the risks non -conformity would 
create.  
2.2.  TBT Agreement aims to strike a balance between the right of Members to impose procedures 
ensuring that ris ks are effectively addressed and the need to avoid unnecessary obstacles to trade 
created by conformity assessment procedures. By referring in particular to the need to take into 
account the risks of non -conformity, the TBT Agreement incorporates the notio n that risk 
assessment is a crucial factor for Members in choosing and designing appropriate and 
proportionate conformity assessment procedures.  
2.2  Risk assessment  
2.3.  Members and their regulators have to choose and design conformity assessment procedures 
so that  they can be confident that products comply with their requirements, while allowing trade to 
flow smoothly. Therefore, the benefits that conformity assessment can be expected to bring should 
be balanced against the costs and delays in accessing the market that stem from conformity 
assessment. To identify such benefits, it is necessary to assess the potential impact of a non -
compliant product being placed on the market (the risk of non -conformity).  
2.4.  Risk assessment is, therefore, a crucial factor for the choi ce and design of appropriate 
conformity assessment procedures. High -risk products (products with high damage potential) need 
to be subject to strict conformity assessment procedures; in such cases the associated costs are 
justified. For lower -risk products  (products with lower damage potential) more flexible and less 
costly and time -consuming conformity assessment procedures should be used. Indeed, during the 
thematic session on risk assessment of 13 June 2017 some Members presented the role of risk 
assessm ent in their system and explained that conformity assessment procedures and inspection 
schemes are calibrated on the nature of risks posed by the products at stake.  
2.5.  The choice of conformity assessment procedure also involves establishing the right balance 
between procedures ex-ante, i.e. procedures assessing the conformity of products before these 
                                                
3 The Invisible Barriers to Trade – How Businesses experience non -Tariff Measures, Geneva: ITC, 2015, 
see figure 7, page 20, 
http://www.intracen.or g/uploadedFiles/intracenorg/Content/Publications/how%20business -ntf.pdf . 
4 Navigating non -tariff measures: Insights from a business survey in the European Union, Geneva: ITC -
EC, 2016, Table 1, page 7 , 
http://www.intracen.org/uploadedFiles/intracenorg/Content/Publications/Navigating_Non_Tariff_Measures_ITC
_EC__final_Low -res(1).pdf . 
5 JOB/TBT/224, paragraph 2.9. Fo r instance, in 2016, conformity assessment procedures were at issue 
in 13 of 31 (42%) new STCs discussed. On the other hand, the share of new notifications submitted in 2016 
that deal with conformity assessment procedures was much lower (13%).  G/TBT/W/462  
 
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  can be placed on the market, and procedures ex-post, i.e. assessing whether products placed on 
the market actually comply with the applicable requirements.  
2.6.  After assessing the risk of non -conformity of specific categories of products, regulators 
should in particular decide whether the risks at stake are lower and can be addressed through 
first-party testing and the use of Supplier's Declaration of Conformity (SDoC)  – together with 
appropriate ex-post market surveillance - or are higher, thereby requiring systematic ex-ante 
third-party involvement. In the latter case, regulators should design and choose the most 
appropriate third -party procedures among the many diffe rent possible ways, which may include 
elements such as governmental type approval, quality assurance of the final product, quality 
assurance of the production process, product verification, unit verification, or combinations of 
these elements.  
2.7.  In the EU, D ecision 768/2008/EC6 provides that regulators choose – from a range of given 
modules – the appropriate conformity assessment procedure in accordance with a set of criteria 
including: the type of product; the nature of the risks entailed by the product; whe re third party 
involvement is mandatory, the need for the manufacturer to have a choice between quality 
assurance and product certification; the need to avoid imposing procedures which would be too 
burdensome in relation to the risks at stake .7 
2.8.  Risk assessment can be embedded in good regulatory practices such as regulatory impact 
assessment, which can inform regulators' decisions, not only on the possible need for regulation, 
but also on the choice of proportionate conformity assessment procedures.  
2.3  Supplier's Declaration of Conformity (SDoC)  
2.9.  For lower -risk products, an effective way to strike the balance between protecting public 
interests and minimising hindrances to trade is the use - together with appropriate ex-post market 
surveillance - of Supplie r's Declaration of Conformity (SDoC). While their detailed content and 
requirements may vary, SDoC schemes generally provide that suppliers themselves declare under 
their own responsibility conformity of their products with the requirements of applicable l egislation, 
without mandatory third party involvement. The SDoC is based on assessments or tests performed 
by the manufacturers themselves or by conformity assessment bodies chosen by the 
manufacturers.  
2.10.   When deciding on the use of SDoC as conformity assess ment procedure, regulators may 
need to take into account other factors besides the nature of risks, such as the economic 
infrastructure of the sector (i.e. existence or not of certification laboratories) and the production 
system, as well as the ex-post market surveillance and product liability regimes which complement 
the assumption of responsibility by manufacturers.  
2.11.   SDoC schemes are generally regarded as bringing advantages to businesses, increasing the 
offer of products available to consumers, and facil itating trade. From the manufacturers' 
perspective, the main advantages are considered to be: lowering costs of demonstrating 
compliance; giving more control over time and access to market and often shortening time -to-
market; giving the choice of testing o r certification bodies. According to a 2008 OECD study, 
empirical evidence clearly showed, in two out of three sectors considered, that intra -EU trade flows 
and imports from extra -EU countries – especially imports from non -OECD countries - increased for 
products subject to SDoC schemes .8 
2.12.   In the EU, SDoC applies to categories of (lower -risk) products in the fields of: electrical 
equipment, machinery, toys, medical devices, cosmetics, personal protective equipment, radio 
equipment. This procedure, which is "M odule A - internal production control" under Decision 
768/2008/EC, provides that the manufacturer ensures and declares on his sole responsibility that 
the products concerned satisfy the applicable legislative requirements. It covers both design and 
product ion. Manufacturers' obligations include establishing the technical documentation, which 
                                                
6 Decision 7 68/2008, Article 4.  
7 For more information on risk assessment in the EU, reference is made to the presentation given at the 
thematic session of 13 June 2017, G/TBT/GEN/ 226; RD/TBT/222.  
8 OECD Technical Barriers to Trade: Evaluating the Trade effects of sup pliers declaration of conformity, 
2008.  G/TBT/W/462  
 
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  may be requested and checked by market surveillance authorities in the context of post -market 
controls, and affixing the required conformity marking .9 
2.4  The role of marke t surveillance and of customs  
2.13.   Market surveillance is an essential tool for the enforcement of product legislation. It helps 
protect users against unsafe products and general non -compliance, as well as businesses from 
unfair competition by those who infring e the rules. Market surveillance involves monitoring 
products placed on the market so as to ensure that they comply with applicable requirements, and 
taking remedial action when products do not comply. An effective market surveillance system also 
implies t hat penalties proportionate to any infringements are in place.  
2.14.   Any type of conformity assessment procedure requires an adequate level of post -market 
surveillance; the objective should be achieving a balance between pre -market and post -market 
controls which  corresponds to the risk to be managed and to the particular circumstances of the 
market. The development of adequate quality infrastructure and market surveillance capacity is 
important to enable regulators to choose more flexible conformity assessment pr ocedures that 
facilitate trade, and therefore to support the implementation of the relevant TBT Agreement 
provisions. Market surveillance authorities need to have sufficient and appropriate powers, 
competences and resources.  
2.15.   Many Members confer responsibil ity to their customs to ensure that imported products have 
been assessed as being compliant with applicable technical requirements. Related customs checks 
can be of very different nature and intensity, and affect trade in different ways: for example, 
systematic verification at the border may create barriers to trade, and systematic re -testing at the 
border risks blocking products for long, which may even deter traders from seeking to access a 
particular market. Proportionate customs checks adapted to the ri sk to be managed should be part 
of the balance between achieving sufficient assurance of conformity and avoiding barriers to trade. 
In the EU, it is on basis of risk analysis that customs authorities and market surveillance 
authorities check products impor ted from countries outside the EU. In addition, under EU 
legislation the importer established in the EU has a key role to play in guaranteeing that only 
compliant products are imported and placed on the EU market. The importer must ensure that the 
manufact urer has correctly fulfilled his obligations with respect to the appropriate conformity 
assessment, including SDoC.  
2.16.   In the EU, market surveillance is a responsibility of Member States authorities, which act 
within a common EU framework10. Member States must  organise and carry out market surveillance 
activities in accordance with EU requirements. National market surveillance authorities have clear 
obligations to proactively control products on the market, and ensure coordination between 
themselves at national  and EU level. Certain checks (tests, inspections) can be delegated to other 
bodies but the official authorities must retain full responsibility for the decisions taken. To avoid 
conflicts of interest, conformity assessment bodies cannot be responsible for  market surveillance. 
EU legislation also lays down obligations applicable to businesses, which have to cooperate with 
national market surveillance authorities and take corrective action where necessary.  
3  PREVIOUS WORK OF THE  TBT COMMITTEE  
3.1.  The TBT Committee  has already carried out significant work on conformity assessment11. 
Already the report of the Fourth Triennial Review12 gave account of exchanges of information and 
experiences on various aspects of conformity assessment procedures. It also identified thre e areas 
of work: i)"Approaches to Conformity Assessment" relating to the factors influencing the choice 
and design of appropriate conformity assessment procedures, including the possible use of SDoC; 
ii) "Use of relevant international guides and recommenda tions"; and iii) "Facilitating the 
recognition of conformity assessment results". These three areas of work have been confirmed in 
subsequent Triennial Reviews.  
                                                
9 Decision 768/2008/EC . 
10 Regulation (EC) No 765/2008.  
11 See the Note by the Secretariat "Overview of the TBT Committee's work on conformity assessment 
procedures", JOB/TBT/224 . 
12 G/TBT/19  G/TBT/W/462  
 
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  3.2.  During the Fifth Triennial Review (2009), and with a view to facilitating trade, the Committee 
agreed, inter alia, to exchange information on the criteria, methods of analysis and concepts used 
by Members to inform their evaluation of the range of choices of conformity assessment 
procedures, including in the context of a risk management framework13. In the Sixth Triennial 
Review (2012) Members agreed to continue such exchange of information and experiences.  
3.3.  Over the years, the TBT Committee held several workshops or thematic sessions dedicated to 
topics related to conformity assessment. Most recently,  the thematic sessions of 28 March 2017 on 
conformity assessment procedures and of 13 June 2017 on risk assessment should be recalled. 
These events showed that these topics attract great attention among Members.  
3.4.  It should also be emphasised that, in the Fi fth Triennial Review (2009), the Committee 
agreed to initiate work on developing practical guidelines on how to choose and design efficient 
and effective mechanisms aimed at strengthening the implementation of the TBT Agreement in the 
area of conformity as sessment .14 While no concrete follow -up has been given so far to this 
important mandate to develop practical guidelines, the European Union considers that it represents 
a sound basis for the future work of the Committee in this area.  
4  PROPOSAL  
4.1.  In the light o f the above, and to improve the implementation of the provisions of the TBT 
Agreement, the European Union proposes that, building on the substantial work done so far and on 
the 2009 mandate to work on developing practical guidelines, the TBT Committee:  
a. Initiates work to develop recommendations or practical guidelines to support regulators 
in the choice and design of appropriate and proportionate conformity assessment 
procedures, for example by setting out an indicative list of criteria related to risk 
asses sment and other relevant factors. This work could also seek to identify elements of 
conformity assessment that regulators can use in designing the appropriate procedures;  
b. Continues and intensifies, in particular through thematic sessions, the exchanges of 
information and experiences on market surveillance (post -market controls) as an 
important element complementing appropriate and proportionate conformity assessment 
procedures (pre -market controls).  
 
 
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13 G/TBT/26, para. 19(b).  
14 G/TBT/26, para. 19(c).