RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/35 
24 May 2005 
 (05-2104) 
Committee on Technical Barriers to Trade  
  
MINUTES OF THE MEETING OF 22-23 MARCH 2005 
 
Chairperson:  Mr. Sudhakar Dalela (India)
 
 
Note by the Secretariat1 
 
I. ADOPTION OF THE AGENDA......................................................................................................... .......2  
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT ...................................2  
A. STATEMENT FROM MEMBERS UNDER ARTICLE 15.2...................................................................................2  
B. SPECIFIC TRADE CONCERNS .......................................................................................................................2  
1. New Concerns ................................................................................................................... ....................2  
2. Concerns Previ ously Raised..................................................................................................... .............3  
C. OTHER MATTERS ............................................................................................................................... ........8  
1. Procedures established at the C odex Alimentarius Commission ..........................................................8  
III. TRIENNIAL REVIEW............................................................................................................... ............9  
A. ISSUES ARISING FROM THE THIRD TRIENNIAL REVIEW ..............................................................................9  
1. Good Regulato ry Prac tice....................................................................................................... ..............9  
2. Transparency Procedures ........................................................................................................ .............9  
3. Conformity Assessment .......................................................................................................... .............10  
4. Technical a ssistance........................................................................................................... .................11  
5. Other Elements................................................................................................................. ...................12  
B. PREPARATION OF THE FOURTH TRIENNIAL REVIEW .................................................................................13  
IV. TECHNICAL CO-OPERATION......................................................................................................... 15 
V. TENTH ANNUAL REVIEW............................................................................................................ ........17  
A. IMPLEMENTATION  AND  OPERATION  OF THE  AGREEMENT  (ARTICLE  15.3) .........................17  
B. THE  CODE  OF GOOD  PRACTICE  (ANNEX  3) ...................................................................................17  
VI. OBSERVERS...................................................................................................................... ...................17  
A. REQUESTS FOR OBSERVER STATUS ..........................................................................................................17  
B. UPDATING BY OBSERVERS .......................................................................................................................17  
VII. ELECTION OF CH AIRPERSO N .......................................................................................................1 7 
VIII. DATE OF NEXT  MEETI NG........................................................................................................... 17 
ANNEX 1: TBT WORKSHOP ON SUPPLIER'S DECLARATION OF CONFORMITY.........................18  
ANNEX 2:  ON-LINE COMPLETION  OF TBT NOTIFI CATIONS ...........................................................44  
ANNEX 3: WORK PROGRAMME FOR THE FOURTH TRIENNIAL REVIEW....................................45  
 
 
                                                      
1 This document has been prepared under the Secretariat's ow n responsibility and is without prejudice to the positions of 
Members and to their rights and obligations under the WTO. G/TBT/M/35 
Page 2  
 
I. ADOPTION OF THE AGENDA 
1. The Committee adopted the agenda contained in WTO/AIR/2517.   
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENT FROM MEMBERS UNDER ARTICLE 15.2 
2. The Chairman  drew the Committee's attention to thr ee new statements on Implementation and 
Administration of the Agreement, submitted by  Sierra Leone (G/TBT/2/Add.83), the Former 
Yugoslav Republic of Macedonia (G/TBT/2 /Add.84) and the Republic of Rwanda 
(G/TBT/2/Add.85).2  He informed the Committee that the latest information on Members' enquiry 
points was available on the TBT webpage.3 
B. SPECIFIC TRADE CONCERNS  
3. The Chairman  drew the Committee's attention to the recommendation of the Third Triennial 
Review, that encouraged Members to share with the Committee, on a voluntary basis, any follow-up 
information on issues that had previously been rai sed in regard to their technical regulations and 
conformity assessment procedures. 
1. New Concerns 
(i) Indonesia - Mandatory Standard for Tyre (G/TBT/N/IDN/13)  
4. The representative of the European Communities  noted that the above notified Decree on 
compulsory implementation of the Indonesian Na tional Standard on Tyre had been adopted on 
23 September 2004.  It allowed for a six month delay for implementation.  Following bilateral 
consultations with the Indonesian authorities, th e European Communities had requested confirmation 
that the entry into force of the Decree woul d be postponed until January 2006, rather than 
implemented on 23 March 2005 as originally fores een.  The European Communities reiterated its 
request that the technical guidance be simplified in order to facilitate the implementation of the 
decree.  Clarification was also sought as to wh ether the Indonesian authorities would accept tyres 
complying with the UN-ECE regulations. 
5. The representative of Indonesia  confirmed that his authorities were planning to postpone the 
entry into force of the Decree. 
(ii) European Communities: Restrictions on the Use of Certain Phthalates in Toys 
6. The representative of the United States  expressed her delegation's concerns about restrictions 
on the use of certain phthalates in toys.  The directiv e at issue restricted the use of phthalates in toys 
and childcare articles for children three years and younge r that "can be put into the mouth".  Although 
the European Communities had notified a similar, but less restrictive technical regulation in 1999 
(G/TBT/Notif.99/578), the United States requested th at the proposed amendment to Council Directive 
76/796/EEC, of 28 September 2004, also be notified to the TBT Committee given the significant revision and its potential to affect international tr ade.  The European Commu nities also needed to 
explain the rationale and justification for the propos ed amendment.   The US concern was that the 
new provision greatly expanded the potential list of pr oducts in the industry directly affected by the 
directive.  The representative of the United States was of the understanding that the EC legislation 
                                                     
 
2 A full, updated list of statements under Article 15.2 is c ontained in document G/TBT/GEN/ 1/Rev.2 and an updated list of 
enquiry point contacts is cont ained in G/TBT/ENQ/26.   
3 http://www.wto.org/english/tratop_e /tbt_e/tbt_enquiry_points_e.htm.  G/TBT/M/35 
 Page 3 
 
 
was in the second reading by parliament and sh e noted that the U.S. Consumer Product Safety 
Commission had been in contact with its counterpart in the European Commission. 
7. The representative of the European Communities  confirmed that the proposal was being 
examined by the European Parliament and the Counc il of Ministers and that it had been substantially 
amended.  The adoption of the Common Position by the Council of Ministers was expected to take 
place in April 2005.  After adoption, the draft would be notified under the TBT Agreement and a 
sufficient time period for comments would be provided. 
(iii) China: General Standard for the Labelli ng of Pre-packaged Alcoholic Beverages 
(G/TBT/CHN/72) 
8. The representative of the European Communities  recalled that his delegation had previously 
expressed concerns regarding the Chinese TBT no tification on labelling for pre-packed food 
G/TBT/CHN/33.  The European Communities now wished  to raise similar concerns with respect to 
the above notified measure on alcoholic beverages as it was the EC view that this measure could 
create difficulties for the EU manufacturers of alc oholic beverages when exporting their products to 
China.  The representative of the United States  associated herself with the comments made by the 
representative of the European Communities and recalled that she had raised this issue in the context 
of China's Annual Transitional Review Mechan ism at the last meeting of the Committee.4  
9. The representative of China  noted that, as had been requested by the European Communities, 
her authorities had agreed to extend the comment  period until 31 March 2005, even though adoption 
of the measure had been set to take place 90 days after the circulation of the notification by the Secretariat. 
(iv) Malaysia – Hologram Stickers on Pharmaceutical Products 
10. The representative of the United States
 raised an issue regarding Malaysian requirements for 
hologram stickers on pharmaceutical products.  It  was the US understanding that on 26 June 2004, 
Malaysia's Ministry of Health had announced th at it had approved implementation of a directive 
requiring the use of hologram stickers on pharmaceu ticals, over-the-counter medications and certain 
herbal products.  That regulation had never been  notified as a proposal under the TBT Agreement and 
Members had therefore not been given an opportuni ty to comment.  The US government and industry 
had raised the issue with their Malaysian counterpa rts and, in fact, implementation had been delayed 
on two separate occasions.  Nevertheless, it w as now scheduled for 5 May 2005.  While the 
representative of the United States welcomed the coope ration that Malaysia had shown, she remained 
of the view that a notification needed to be made under the TBT Agreement. 
11. The representative of Malaysia  took note of the concern raised and informed the Committee 
that the notification was being prepared and would be submitted. 
2. Concerns Previously Raised 
(i) Korea:  Import of Fish Heads 
12. The representative of New Zealand  reiterated that her authorities did not consider as 
legitimate the concerns raised by Korea in relation to  the import of this fish heads:  they were not 
justifiable, whether considered in terms of GATT Ar ticle XI or under the relevant provisions of the 
TBT Agreement.   In fact, the representative of Korea had informed New Zealand that his country 
would continue to prohibit imports of fish heads from New Zealand while allowing imports of edible 
fish heads from certain other exporting countries.   This was despite assurances that New Zealand 
                                                      
4 The US concerns in this resp ect are contained in G/TBT/W/245. G/TBT/M/35 
Page 4  
 
could process hake heads to an edible standard.  Provided the product was accompanied by official 
certification giving assurance that the product was fi t for human consumption, it was New Zealand's 
view that Korea was obliged to allow the importation.   This was the practice with most other sea food 
products exported to Korea and would seem to be an  appropriate and adequate way of ensuring that 
any human health or safety concerns were addressed. 
13. The representatives of Iceland
, the European Communities  and Norway  expressed similar 
concerns and hoped that a solution could be found pursuant to bilateral consultations. 
14. The representative of Korea  noted that there had been some positive progress achieved in 
bilateral consultations, particularly with the Un ited Kingdom.  More discussions were needed with 
Norway, Iceland and New Zealand.  
(ii) European Communities:  Regulation on the Regi stration, Evaluation and Authorisation of 
Chemicals(REACH) – (G/TBT/W/208 and G/TBT/N/EEC/52 and Add.1.) 
15. The representative of Japan  noted that her delegation rema ined concerned about the trade-
restrictiveness of the proposed measure.  In particul ar, the provisions for the registration of substances 
in articles were obscure and implied a heavy burden on registrants.  In consultations, the European 
Communities had responded that there was ampl e time for manufacturers and importers to get 
acquainted with this system and that the guidan ce on substances in articles would be developed.  
However, Japan could not judge from such expectat ion-based explanations that an excessive burden 
to the registrant would not arise. Japan had also emphasized many times the need to avoid duplicative 
registrations. Regarding the forma tion of consortia, it was not clear whether every manufacturer and 
importer who wanted to join a consortium could do so in a timely manner and under fair cost-sharing.  
In respect of Article 6.5, Japan had emphasized th at this provision could be disadvantageous to 
articles produced outside the European Communities and had not yet received a clear explanation from the European Communities why the phrase "by an actor up the supply chain" was necessary.  
Nevertheless, Japan appreciated the EC's efforts to explain the proposal in response to Members' 
concerns.   
16. The representative of the United States
 noted that the record of the last meeting extensively 
described Members concerns;  the United States woul d not repeat their own. She thought that it had 
been helpful to have the EC Commission's experts present at the last meeting and emphasized that 
given the on-going discussion of the proposal by the European Parliament and Member States, it was 
premature to draw conclusions and interpretations in particular about compliance with WTO rules, 
such as those of the TBT Agreement.  The United States remained hopeful that the EC Commission 
would revise its proposal and ensure that it did not become an unnecessary barrier to trade.  
17. The representative of Australia  noted that while her delegati on supported the basic objectives 
of the draft regulation, and, in fact, welcomed the harmonisation of chemicals regulation across the European Union, her delegation remained concerned that it was more trade restrictive than necessary 
to fulfil its objectives;  it did not focus on substa nces that presented the greatest risk.  Australia was 
particularly concerned about the unintended nega tive consequences of REACH for the minerals and 
metals industry.  An unintended c onsequence of the legislation was that it was discriminatory in its 
application to raw inorganic imports such as impor ts of minerals while ex empting organic imports 
such as coal, gas and oil.  This placed the inor ganic industry at a competitive disadvantage to the 
organic sector.  To maintain consistency and fair competition the same approach needed to be taken 
for alloys as for polymers i.e., to register (and author ise) the use of metal in the alloy but to exempt 
the requirement to register and authorise the metal in the downstream uses of the alloy.  The special 
qualities of alloys needed to be recognised:  they could not simply be treated as the sum of their 
constituent parts.  The inclusion of secondary raw materials in the scope of REACH would discourage 
recycling within the EU of some metals and alloys  and would further disadvant age the metals sector.  
In Australia's view, REACH had to allow for cu rrently available assessments and data sets, and  G/TBT/M/35 
 Page 5 
 
 
consideration needed to be given to the use of inte rnationally agreed definitions determined in other 
fora.  The extra requirements imposed by REACH could result in some products, which Australia 
wished to continue to source, becoming uneconom ic to produce and hence being withdrawn from the 
market.  This was of particular concern to Australia  as a net importer of chemical substances from the 
EU.  The draft legislation exempted from registra tion substances in articles that had already been 
registered for a specific use by an actor of the s upply chain.  This could induce manufacturers within 
the EU to source their imports for the registered u se from the EU rather than third country suppliers. 
18. The representative of Mexico  echoed the concerns voiced by the preceding delegations and 
agreed, in particular, with the point made by th e United States:  it was premature to analyse the 
compatibility of the draft regulation with EC co mmitments under the TBT Agreement.  On special 
and differential treatment, Mexico recalled that hi s delegation had indicated that this type of 
regulation would have an impact on exports from developing countries a nd that it would therefore be 
important to take account of the special circumstan ces prevailing in developing countries so that they 
would not be unduly affected.  On technical assistance, Mexico was of the view that the complexity of 
the system and the difficulty of implementing it made it clear that technical assistance would be 
needed.  He recalled that his delegation had co mmented on the original REACH proposal in May 
2003 but had still not received any response to those comments.  
19. The representative of Chile  noted that her country shared the concerns of previous speakers, 
particularly those of Australia.  Without prejudice to any possible future modifications to the draft 
regulation, Chile was interested in knowing how the European Communities would extend technical 
assistance in order to facilitate compliance.  It was pa rticularly important that the rules be specific in 
order to avoid different interpreta tions and arbitrary implementation.  Chile continued to be concerned 
that REACH seemed to work as a function of pro duction and export volumes, rather than the risk 
associated with the product.  For instance, as an exporter of minerals to the European Union, the 
impact of REACH could mean that each shipment would need to be registered.  This entailed 
significant costs. 
20. The representative of Cuba  reiterated the concerns expressed by his delegation at the last 
meeting of the TBT Committee.5  While the European Communities had recognised their obligations 
under Article 11.3 of the TBT Agreement to provide  guidance material regarding the implementation 
of REACH, as well as technical assistance, the representative of Cuba was unaware of any specific action in this respect.  He pointed out that the non- existence in the REACH text  of any unified list of 
chemical substances or products made it difficult to  comply with the requirements for registration;  
such a list needed to be created and disseminated.  Finally, it was requested that the EC Enquiry Point 
make public the replies to the comments made on the second notification of REACH.   
21. The representative of Korea
 noted that his country's chemical industry was concerned about 
the burden created by REACH, especially with respect  to the possibility that confidential commercial 
information could be released in the process of re gistration.  Also, many countries faced problems in 
implementing Good Laboratory Practices (GLP) and the representative of Korea hoped that the 
European Communities would take this into account. 
22. The representative of China  suggested that the Europ ean Communities should assess the 
negative impact of REACH regulations on deve loping countries and add provisions in REACH 
specifying the special and differential treatment fo r chemicals from developing countries.  Secondly, 
there was a need to simplify the requirements of registration and authorisation as well as to cut down 
application fees to reduce the burden on industry.  Small and Medium-sized Enterprises (SMEs) in 
developing countries needed to be exempt from such  expenses.  Finally, it was suggested that the 
European Communities clarify the coverage of REACH on waste chemicals and how duplication or 
overlap was avoided when other regulat ions or directives were applicable. 
                                                      
5 G/TBT/M/34, para 48. G/TBT/M/35 
Page 6  
 
23. The representative of Uruguay
 stressed the issue of market access effects on products 
exported from developing countries a nd emphasized the need for technical assistance in order to 
facilitate the implementation of the system. 
24. The representative of the European Communities  reminded Members that the proposed 
REACH regulation was being examined by the European Parliament and the Council of Ministers 
under the Co-Decision Procedure and the Commissi on would update its notification to the TBT 
Committee if there was any major change to the proposal.  Moreover, the European Communities 
would continue its efforts to explain REACH to  WTO Members and to develop guidance as well as 
pursue bilateral and multilateral dialogues.  Concer ning the request from Mexico to have a written 
answer to the comments made, the European Comm unities had not replied formally to any of the 
6,000 comments that had been made in response to its internet consultation.  In effect, the response to 
these comments was a change to th e proposal itself and the way in which those comments were being 
taken into account was set out in the explanatory memorandum accompanying the proposal.  Nevertheless, the European Comm unities remained willing to conti nue the dialogue on outstanding 
questions.  Regarding the point made by Cuba, the answers to the comments received by WTO 
Members had been made public and were  available on the EC TBT website.  
(iii) European Communities:  Regulation on Certai n Wine Sector Products (G/TBT/N/EEC/15, 
Corr.1-2 and G/TBT/N/EEC/57) 
25. The representatives of New Zealand
, Australia , the United States , Uruguay  and Mexico  
recalled their delegations' concerns with the EC Regulation 753/2002 and 316/2004 relating to wine 
labelling, and stressed that concerns regarding th e creation of unnecessary obstacle to trade remained 
unresolved.  They did not find it necessary to repeat concerns raised at every meeting of the TBT 
Committee since June 2002.  For New Zealand it su fficed to note that her delegation continued to 
seek written responses from the European Commission on the full range of issues that were both 
substantive and procedural in na ture.  The representative of the United States expressed frustration at 
the fact that the European Commission did not seem to  appreciate the concerns that had been raised:  
responses had not been adequately answered and th e European Communities appeared merely to be 
restating that comments had been taken into account and that the wine labelling rules at issue were 
justified.  The representative of Mexico remark ed at the difference in openness and transparency, as 
well as willingness for dialogue, in the case of REACH compared to wine labelling. 
26. The representative of the European Communities  stressed that the Eu ropean rules on labelling 
had been amended on 20 February 2004 in EC Regul ation 316/2004.  This amendment had taken into 
account the comments relating to the previous re gulation (753/2002).  The European Communities 
had taken note of further comments made since those amendments were adopted, however, it was 
their view that the current legislation was legitimate.  
(iv) Switzerland:  Ordinance on the Emission Level  of Passenger Cars with Compression Ignition 
Engines (G/TBT/N/CHE/39) 
27. The delegation of Switzerland  wished to update the Committee on an issue raised by the 
European Communities at the last  meeting. This was specifically about Point 12 of the above-
mentioned TBT notification on requirements for diesel  filters used in motor vehicles.  Switzerland 
was not yet in a position to give a definitive response to the comments made by Members as the legislative process in the Swiss parliament was cu rrently underway.  Nevertheless, the concerned 
Members would be informed of the outcom e once this process had been completed. 
(v) United States:  Measure on Refillable Lighters 
28. The representative of the United States
 reverted to an issue raised by China regarding a US 
regulation on refillable lighters.  China had asked  a specific question about the possible use of the  G/TBT/M/35 
 Page 7 
 
 
ISO 9994 standard, a safety specification for lighters.   The United States info rmed the Committee that 
the U.S. Consumer Products Safety Commission was currently considering the issue and her 
delegation would report back when a final decision had been reached.   
29. The representative of China  reiterated her country's concerns as expressed at the previous 
three  meetings of the TBT Committee regarding the US safety standard on lighters.  China had also 
requested that the United States no tify the measure to the WTO, in  accordance with Article 1.6 and 
2.9 of the TBT Agreement.  While China was pl eased to hear that US government agencies were 
working on the possibility of taking the afore-menti oned international standard  into consideration, 
China was also concerned that over the past two y ears, the US child resistant standards had been 
followed by some other Members of the WTO.  Th e representative of China strongly urged the United 
States to abide by the rules of the TBT Agreement a nd to amend the standard so as to bring it in line 
with ISO 9994:2002. 
30. The representative of the United States  reminded the Committee that the regulation in 
question had originally been published in 1993 and th at the ISO standard which China had refered to 
dated to 2002.  The United States had provided Chin ese officials with the original documentation and 
studies that supported the approach taken by the U. S. Consumer Products Safety Commission which, 
in fact, showed that price had a relationship to safety.   In terms of the notification, in April 2004, the 
U.S. Consumer Products Safety Commission had pub lished a notice which was about an inflation-
related adjustment (change in the whole-sale price inde x).  This did not in itself constitute a change in 
the regulation, nor was it an amendment to the regula tion.  The fact that a notice had been published 
was simply an additional measure of transparency ;  the regulation, as published in 1993, remained 
unchanged, and, accordingly, the United States did not think that there was a basis for making an 
additional notification. 
(vi) United States: Country of Origin Labell ing (G/TBT/USA/25 and USA/83 and Corr.1) 
31. The representative of Canada  wished to raise a number of its ongoing concerns regarding the 
United States' mandatory country of origin labelling program set out in the US Farm Bill and referred 
to as "COOL".  In particular, some aspects of the Bill affecting the imports of fish and seafood, were 
due to be implemented in April 2005.  It was noted th at the stated intent of the legislation was not to 
address food safety or animal health concerns bu t rather to provide consumers with additional 
information on which to base their purchase decision s.  The Canadian government was of the view 
that COOL was inconsistent with  the US obligations under the TBT Agreement as it was more trade 
restrictive than necessary to fulfil the stated objectiv e.  Canada had yet to be provided with evidence 
justifying the adoption and implemen tation of COOL.  In Canada's view, mandatory COOL also ran  
counter to the US industry's long term interests and that of other countries, including Canada.  As the 
USDA's own cost benefit analysis had indicated , the volume of US exports for all covered 
commodities would decline as a result of COOL as would US imports from other countries, and this would negatively affect the American food pr ocessing industry.  The US government had not 
provided any evidence that mandatory COOL would benefit consumers as a retail labelling program.  
On the contrary, mandatory COOL in the United St ates could set a precedent for more extensive and 
trade restrictive non-food safety related labelling schem es internationally.  There was evidence of this 
in the ongoing debates on the necessity of devel oping COOL standards in the Codex Committee on 
Food Labelling.  The Interim Rule for Fish and She llfish, due to be implemented on 4 April 2005 (all 
other covered commodities being delayed until 2006), would place that entire sector at a competitive 
disadvantage relative to the other covered comm odities including the poultry sector which, seemingly 
arbitrarily, was not covered by the labelling program.  It wa s requested that the implementation of the 
Interim Rule be delayed and the Final Rule repealed. 
32. The representative of China
 supported the above-mentioned co ncerns raised by Canada. G/TBT/M/35 
Page 8  
 
33. The representative of the United States
 stated that she was aware of Canada's concerns and 
would revert to them. 
(vii) Peru: Labelling of footwear (G/TBT/N/PER/4) 
34. The representative of Peru  wished to refer to comments ma de by the European Communities 
at the TBT Committee meeting of 4 November 2004.  It was pointed out that the above-mentioned 
regulation had been notified twice; it had been adopted six months after last notif ication, and all of the 
comments to the first notified m easure had been taken into account.  In respect of the recent EC 
comments, the representative of Peru recalled that the labelling regulation stated that the country of 
origin information had to figure on printed, stampe d or sewn labels.  The information with respect to 
the corporate tax number could be struck on, or  glued.  Regarding imported goods, this same 
information could be given by the manufacturer or the importer once the goods had entered the 
territory of Peru. 
(viii) Mexico: Pre-packaged products (G/TBT/N/MEX/95) and Mexico: Standard for Glazed Pottery 
Ware, Glazed Ceramic Ware and Po rcelain Ware (G/TBT/N/MEX/69) 
35. The representative of Mexico  informed the Committee that with respect to both the above-
mentioned technical regulations, b ilateral consultations were ongoi ng and some agreement had been 
reached on how to deal with the comments prev iously raised by the European Communities. 
C. OTHER MATTERS  
1. Procedures established at the Codex Alimentarius Commission 
36. The representative of Chile  informed the Committee of her country's concern with respect to 
an ongoing situation in the Codex Alimentarius that had impeded adoption of certain modifications to 
a particular standard.  She recalled that Codex standards were relevant both for the WTO SPS and 
TBT Agreements.  Therefore, it was important that  the procedures established by the Codex ensured 
credibility in the process of development of internatio nal standards.  In the Codex, this process itself 
followed clear criteria and rules on the basis of scientific evidence. 
37. In the specific case at issue, Chile had worked  for a period of eight year to achieve the 
inclusion of a common Chilean species of sardines ( Clupea Bentincki ) in the Codex Standard for 
Canned Sardines and Sardine Type Pr oducts.  Chile had complied with all applicable requirements for 
the inclusion of new species.  These requirement s themselves had been approved, in 1998, by the 
Codex Committee on Fish and Fishery Products with  no opposition from any participating country.  
Nevertheless, when Chile's requ est was submitted to the Codex Alimentarius Commission for final 
approval, no consensus had been achieved. Some co untries had asked for a revision of the procedures 
for the inclusion of new species because they felt that these were incomplete, and that the current 
standard did not meet the appropriate level of prot ection for the consumer.  While Chile supported the 
initiative to review the procedures, it would not  do so as a condition for the acceptance of the 
inclusion of the common Chilean sardine.  Developi ng countries, such as Chile, needed to rely on 
clear and stable rules.  The non-approval of Chile 's request would mean ignoring current procedures, 
flouting the rights of those who had respected them (and sought to comply with them for eight years 
in Chile's case) and make it impossible to include ne w species in the short run.  This would become a 
barrier to trade and would cast doubts on the pro cedures of the Codex itself as well as undermine the 
credibility of the Codex as a referenced sta ndard-setting organization at the WTO.   
38. The representative of Chile went on to suggest that , in order to ensure that these barriers to 
trade did not emerge in the standard-setting orga nisations, the TBT Committee could consider adding 
to those criteria that it had defined in the year 2000 in order to ensure that standards became relevant  G/TBT/M/35 
 Page 9 
 
 
international standards.6  In Chile's view, these standards setting organizations needed to comply with 
their own agreed procedures.  Chile would draw up a specific proposal on this subject for the next 
meeting of the Committee and hoped that it would be included in the up-coming Fourth Triennial 
Review. 
39. The representative of Mexico  was of the view that the matter deserved consideration by the 
TBT Committee and Mexico would revert to the issue with specific comments. 
40. The representative of the United States  stressed the need to understand what the facts at issue 
were, before attempting to establish whether the TB T Committee needed to amend its own work;  it 
be so that the tools were already at Members' disposal.   
41. The representative of the Codex  informed Members that, at the Codex Committee on Fish and 
Fishery Products Committee held recently in Sout h Africa, the inclusion of the specific type of 
sardine mentioned above had been ra ised but there had not been suffici ent time to discuss this issue.  
The Committee had decided to extend the discussion until the next session of the Committee, to be 
held in 2006.  At that point Codex members would discuss both the procedural matters as well 
undertake a more technical consideration of the standard itself. 
III. TRIENNIAL REVIEW 
A. ISSUES ARISING FROM THE THIRD TRIENNIAL REVIEW  
1. Good Regulatory Practice 
42. The Chairman  began by recalling that the Committe e's mandate on Good Regulatory Practice 
in the Third Triennial Review contained three elem ents.  The Committee had, to date, held useful 
discussions pursuant to the first of the three recommendations contained in paragraph 14 of the Third 
Triennial Review, which was the exchange of nati onal experiences related to the identification of 
elements  of Good Regulatory practice at the domestic level.7  In this discussion, a number of issues 
related to Good Regulatory Practice had been menti oned:  these included issues such as transparency, 
harmonization, equivalence, regulatory impact assessment, consensus, representativness and non-
duplication.  The Chairman then went on to reca ll that, pursuant to paragraph 14, the Committee had 
agreed to pursue its work on two other elements .  First, the Committee was to hold focused 
discussions "on, inter alia , choice of policy instruments , mandatory versus voluntary measures, and 
the use of regulatory impact assessments to fac ilitate Good Regulatory Practice" (emphasis added).  
Second, the Committee was to "initiate a process of sharing experiences on equivalency  in the 
Committee particularly with regard to how the concept was implemented in practice" (emphasis 
added).   The Chairman encouraged delegations to  come forward with further submissions on each of 
the three elements of Good Regulatory Practice se t out above (elements, policy instruments and 
equivalency) at the next meeting. 
43. No further issues were raised in relation to th e follow-up of the Third Triennial Review.   
2. Transparency Procedures 
44. The Chairman  recalled that the Committee had held a wide ranging discussion on 
transparency in 2004.  On one particular point , Canada had drawn the Committee's attention to a 
recommendation to examine the feasibility of creati ng a central depository for notifications on the 
WTO website, which would enable Members to complete notification forms on-line on the WTO 
                                                      
6 The principles referred to are contained in G/TBT/1/Rev. 8 under: "IX. Decision of the Committee on Principles for the 
Development of International Standards,  Gu ides and Recommendations with Relation to Ar ticles 2, 5 and Annex 3 of the Agreement ."  
7 See Colombia in G/TBT/W/239, Mexico in G/TBT/W/248 and Chile in Job(04)/163.  G/TBT/M/35 
Page 10  
 
website.  It had been agreed that the Secretariat would look into the feasibility of setting up such a 
facility.   
45. The Committee took note
 of the information provided by the Secretariat in this respect 
(Annex 2, page 44, below).  
46. No further issues were raised in relation to th e follow-up of the Third Triennial Review.   
3. Conformity Assessment 
47. The Chairman  recalled that in Paragraph 40 of the Third Triennial Review (G/TBT/13), the 
Committee had agreed on a Work Programme inte nded to improve Members' implementation of 
Articles 5-9 of the Agreement and promote a better understanding of Members' conformity 
assessment systems.   
(a) SDoC 
48. The Chairman  presented his report on the 21 Ma rch 2005 TBT Workshop on SDoC.8   
49. The representative of Grenada  reiterated the difficulties faced by developing countries 
regarding their participation in the work of intern ational standard-setting orga nizations.  In her view, 
the high cost of such participation was a potential ba rrier to international trade in that it made the 
recognition of conformity assessment more difficu lt.  The Committee needed to find a way of 
addressing this issue because, in fact, in order to benefit from the system one had to be a Member of it.  The representative of Antigua and Barbuda
 supported this point and a dded that ISO/IEC Standard 
on SDoC seemed to be proceeding the same way as ISO 9000:  although purported to be voluntary, 
market forces were making it de facto  mandatory.   
50. The representative of the United States  stressed that SDoC had orig inally been a tool for the 
market place, used for compliance with volunta ry standards as a communication vehicle between 
buyers and sellers.  One important lesson from th e discussion of the workshop was that the updating 
of the ISO standard had been an attempt by industr y to make the document more usable as a tool for 
regulators.  Nevertheless, she stressed, there w as no requirement for any government to use an 
international standard that was not effective or relevant for its domestic regulatory purposes.   
51. The representative of Mexico  stressed the point he had made at previous day's workshop (see 
Annex 1, para. 143, on page 43). 
52. The representative of Egypt  stressed that there was a need  to look at how developing 
countries could benefit from SDoC.  For instance, it had been made clear from the discussions during 
the workshop that there was a need  to establish market surveillance systems when introducing SDoC.  
Yet the capacity to set up such systems in devel oping countries was missing;  the two issues needed to 
be considered together.  
53. The representative of Brazil  stressed that SDoC was a market-based solution to a problem of 
certification, which could have different impacts a ccording to levels of de velopment among countries, 
as well as the size and repute of the companies using it.  It was therefore important to consider the views of certification bodies and those of SMEs.   
                                                     
 
8 The Chairman's summary is contained in  paragraphs 135-142 of Annex 1 (page 18).  G/TBT/M/35 
 Page 11 
 
 
(b) Accreditation Fora 
54. The Chairman  recalled that, during 2004, pursuant to  Paragraph 40 of the Third Triennial 
Review, the Committee had heard presentations on  the operation of accreditation fora and the 
participation of Members, in particular developing country Members, in these fora.9  He noted that 
Paragraph 40 also contained another recommendation wh ich stated that "users, such as certification 
bodies, should also be invited to share their experiences in this respect".  He suggested that at the next 
meeting of the Committee Members would pr ovide information on the experiences of users of  
accreditation, such as certification bodies, in their respective countries. 
55. The representative of the United States  pointed out that, with respect to the recommendation 
relevant to users of accreditati on bodies, such as certification bodies, since these were private bodies, 
it seemed that a good opportunity to follow-up would be in the context of the planned March 2006 
workshop.  She suggested that this be one element to  consider in the prepara tion of a draft programme 
of that event (see paragraph 57, below). 
(c) Other Issues related to Conformity Assessment  
56. The Chairman  recalled that the Committee had discussed other issues relevant to conformity 
assessment during 2004.10   For example, the European Communities had spoken about their "New 
Global Approach" and the representative of Jo rdan had informed the Committee about its 
international product conformity certification programme (DAMAN11).  Likewise, the BIPM and 
OIML had spoken about metrology and the IEC a nd the OECD had provided substantive input on 
relevant on-going work in their organizations.   
57. It was agreed  that the Secretariat would prepare an outline of a draft programme for the 
planned March 2006 workshop on conformity assessment.   
4. Technical assistance 
58. The Chairman  reported on his consultations held on an "issues and options paper" aimed at 
facilitating further discussion on the subject of tran sparency in TBT related technical assistance and 
which sought to find possible ways forward for the Committee.12  
59. He began by noting that there had been genera l support for Option 2.  Members had felt that 
this was a simple, pragmatic and forward-looking approach and offered the most viable course of 
action for the Committee.  There had also been a feeling that Option 2 presented an opportunity for 
the Committee to commence work in the short term a nd that it could prompt the Committee to have a 
substantive discussion based on concrete, specific and current concerns.  Moreover, in the sense that 
Option 2 could create an incentive for follow-up, f eedback and discussion of specific needs by the 
Committee, it could contribute in operationalizing Ar ticle 11.  Information made available would be 
complementary to existing databases.   
60. Nevertheless, some Members had clearly felt that Option 2, by itself, was not sufficient, and 
that there was merit in pursuing the other Options in parallel.  In terms of Option 1, the door needed to 
be kept open:  in the SPS area, the STDF facility w as already functional and it could be useful for the 
Committee to learn from developing countries' experi ence in this regard, and what relevance this 
could have to technical assistance needs in the TBT area.  On Option 3, it had been pointed out that 
                                                      
9 The Committee heard presentations from the International Laboratory Accreditation Co-operation (ILAC), the International 
Accreditation Forum (IAF), the Eu ropean Co-operation for Accreditation (EA).  Th e Committee had also heard a presentation on th e new 
ISO Standard for accreditation (ISO/IEC 17011). 
10 G/TBT/13, Para 40, first tiret, first part  of sentence: "Exchange info rmation and experiences on ex isting conformity assessmen t 
procedures and practices, the use of relevant interna tional standards, guides and recommendations,  .... ". 
11 International Product Conformity Certification Program. 
12 JOB(05)/20, 21 February 2005. G/TBT/M/35 
Page 12  
 
the Committee could address some of the elements  under the existing standing agenda item on 
technical assistance. At a subseque nt phase, the Committee could revert  to the concept in this option 
in light of advances of work on Option 2.  Howe ver, both with respect to Option 1 and Option 3, 
funding, as well as Secretariat resources, remained an  issue.  Hence, while the concepts in these 
options remained on the table, and needed to be furt her explored in light of further developments (the 
door was not closed), they appeared to be more long-term in nature.  
61. In light of the above, the Committee agreed
 to proceed with the voluntary notification of 
specific technical assistance needs and responses (Option 2) while keeping Options 1 and 3 on the table.  The Secretariat would, in cooperation with  the Chairman, circulate a draft notification format 
(for both specific technical assistance needs and res ponses) for Members' consideration ahead of the 
next meeting 
5. Other Elements 
62. The representative of the ISO
 informed the Committee about the publication, in 2004, of the 
new standard ISO/IEC 17000:2004 (Conformity A ssessment – Vocabulary and General Principles) 
and its relation to the revised Guide 2 (ISO/IEC Guid e 2:2004).  He explained that the revised Guide 2 
replaced all previous editions of the Guide;  it ha d replaced clauses 12-17 w ith a cross-reference to 
ISO/IEC 17000.  This maintained the necessary lin kage between the two base vocabulary documents 
for internationally accepted standard ization and conformity assessment  practices.  He suggested WTO 
Members could consider referencing ISO/IEC Guid e 2:2004 which included the cross-reference to 
ISO/IEC 17000:2004.  Apart from the above-mentione d change, there were no other differences 
between the new 2004 edition of Guide 2 and the previous edition published in 1996.  In other words, 
Clauses 1-11 remained in ISO/IEC Guide 2:2004 unch anged.  It was noted that the new ISO/IEC 
17000:2004 provided internationally accepte d definitions for terms that were, inter alia , found in 
Articles 5, 6, 7 and 8 of the TBT Agreement.   
63. The representative of the United States  stressed that there was a need to understand better the 
differences between the 1991 version of Guide 2 and the 1996 version of that same Guide, which 
itself had now been replaced by the above-mentione d 2004 version.  This was an issue the Committee 
would have to look in to.   
64. The representative of Mexico  stressed the possible legal implications arising from a change to 
an international standard that defined the term s used in implementing the TBT Agreement.  In 
addition, reference was made in th e latest revision of Guide 2, to terms used to define conformity 
assessment which were not currently referenced in th e TBT Agreement at all.  He raised the question 
as to whether that, per se , had any consequences on the implem entation of the TBT Agreement's 
provision on conformity assessment.  It would, pe rhaps, be better for TBT Committee to discuss the 
issue rather than leaving it fo r a possible future dispute.  
65. The representative of the European Communities  recalled that this had been discussed at a 
previous meeting of the Committee.13 The key was how to deal with  a situation where an existing 
agreement was out of date:  it could make sense to ch ange the Agreement so as to bring it up to date. 
66. The representative of Cuba  suggested that a factual document be prepared which compared 
the TBT Agreement with the international guide.  
67. The representative of Mexico  was concerned that the Committee would enter into any 
exercise which would entail a modification of the Agreement.  That was not necessarily the best 
option.  He recalled that Article IX of the WT O Agreement permitted the General Council to adopt 
                                                      
13 G/TBT/M/32, para. 106.  G/TBT/M/35 
 Page 13 
 
 
authorised interpretations of the WTO Agreements. The representative of Australia  shared Mexico's 
concern. 
68. Referring to the question raised by the United States, the Chairman  wondered whether the 
ISO wished to comment on the feasibility of comp aring the 1991 and 1996 versions of Guide 2. 
69. The representative of the ISO  noted that any work on terminology was long and tedious.  The 
latest revision had been made necessary by de velopments on the international scene relating to 
conformity assessment.  Nevertheless, should the Committee so wish, the ISO could provide further 
detail, at a later date, on the diffe rences between the vari ous versions.  He emphasized that the new 
version (ISO/IEC Guide 2:2004) only changed the terms relating to conformity assessment.   
70. The Committee  took note of the information provided by the ISO. 
71. In concluding the discussion on the follow-up to the Triennial Review, the Chairman  
remarked that the Committee had now discussed the recommendations under each of the various 
headings of the Review, and taken action accordingl y.  Substantial progress has been made to give 
effect to the mandated follow-up on several elements  of the Review.  This would allow the Committee 
to gradually shift, in line with the Work Prog ramme for the Fourth Triennial Review, into the 
preparation of the Fourth Triennial Review.   
B. PREPARATION OF THE FOURTH TRIENNIAL REVIEW  
72. The Chairman  recalled that at its meeting of 4 November 2004, the Committee had endorsed 
a Work Programme for the preparation of the Four th Triennial Review of the Implementation and 
Operation of the TBT Agreement pursuant to Article 15.4 (Annex 3 on page 45).  In that Work Programme, it had been agreed that the Committee would initiate the review work at the current 
meeting by making a preliminary id entification of topics for the Review.  The Chairman stressed that 
Members would be able to add on or to modify this list during the discussion phase of the review work and to revert to issues and submissions discu ssed on previous occasions.  In addition to the point 
made by Chile in paragraph 36, above, the list of  topics suggested by Members included the following 
(with the Member identifying the topic in parenthesis):  
(a) Implementation and administration of the Agreement (US); 
(b) Good regulatory practice (EC, US); 
(c) Transparency (China, EC); 
(d) Conformity assessment procedures (EC, US); 
(e) Technical assistance (China, EC); 
(f) Special and Differential Treatment (China); 
(g) Intellectual property rights issues in standardization (China); and, 
(h) Labelling (EC). 
73. The representative of the United States
 noted that from her delegation's perspective, there was 
a need, under the Implementation and Administration of the Agreement , to continue the past practice 
of taking stock of which Members had submitted the statements on implementation, as well as 
established enquiry points.  Moving on to the Good Regulatory Practice , this concept was not well 
defined in the TBT Agreement.  Nevertheless, discussions in the Committee had provided an opportunity for Members to deepen their understa nding of how domestic procedures were being 
implemented so as to ensure that regulations di d not create unnecessary barriers to trade.  Further 
discussions on this topic could give an opportunity to  focus more deeply, for instance, on the issue of 
transparency and impact assessment.  On conformity assessment  the representative of the United 
States hoped that the Committee would, during the F ourth Triennial Review, be able to achieve 
greater focus and understanding than what had been  achieved at previous triennial reviews.   G/TBT/M/35 
Page 14  
 
74. The representative of China
 noted that his delegation had identified three areas for 
consideration in the Fourth Triennial Review: transparency, technical assistance and intellectual 
property rights issues in standardization.  In respect of intellectual property rights , he stressed that 
there was a need to avoid conflicts between standardi zation and IPR.  To enhance the efficiency of the 
international standards development process, and to  facilitate Members' adoption of international 
standards, patented technologies that were necessar y to meet the objective of a standard had to be 
treated appropriately to strike the right balan ce between the needs of international standards 
development and the implementation of adequate and fair protection of IPRs.   Accordingly, the 
Chinese government perceived a need for the TBT Committee to discuss, in the framework of the 
Fourth Triennial Review, appropria te policies in this regard.   
75. In particular, it was the view of the Chinese re presentative that international standardizing 
bodies such as ISO, IEC, ITU, ANSI, CENELEC and ETSI had established policies concerning 
patented technologies in standardization.  In these po licies, it had been deemed desirable that the full 
information of patented technologies on patented app lications needed to be disclosed.  It was also 
stipulated that once a patented technology had been promulgated in a standard, the patent holder was 
required to declare that it would accept the RAND Principle in patent usage negotiations (this 
principle, it was explained, entailed that IPR holde rs negotiated with applicants for IPR usage on 
reasonable and non-discriminatory terms and conditions).  Such policies provided the Committee with 
a good technical base and a road map to follow.  It was stressed, however, that there were many IPR 
policies of standardization that needed to be  addressed.  For example, although disclosure was 
important in standards development,  some standardization bodies had declared that they would not be 
responsible for identifying patented rights.  More over, there were no concrete measures to encourage 
IPR holders to disclose related information.  Fina lly, there were no remedy provisions in cases where 
IPR holders would not accept the correct policies.  There were several other technical questions that 
needed to be explored, such as:  at what stage did information need to be disclosed?  who bore the 
responsibility for information disclosure?  who bor e the responsibility for RAND terms arbitrage?  
76. The representative of China stated that althoug h the TBT Committee could not be expected to 
discuss all the above complex questions, since the Agreement encouraged Members to adopt 
international standards and the above-mentioned issues concerning IPRs were important for the 
efficiency and quality of international standards development, the TBT Committee needed to give 
them due consideration.  
77. The representative of the European Communities  noted that on transparency , it was his 
delegation's view that the systematic access to fi nal texts of technical regulations and conformity 
assessment procedures notified under the TBT Agreem ent would be useful insofar as it would allow 
Members who had submitted comments on a notificati on to see how these comments had been taken 
into account.  More discussion in the field of transl ation of notified texts could be useful.  Regarding 
technical assistance , the Committee needed to continue its work  in respect of the elaboration of the 
information coordination mechanism.  Moreover, th e Committee needed to explore ways in which to 
improve the participation of developing countries in  the international standardization process.  On 
conformity assessments procedures , it was stressed that these remained a substantial burden for 
exporters and importers, particularly in cases wher e there were a variety of procedures in domestic 
and foreign markets for similar products.   The Fourth  Triennial Review needed to promote the use of 
appropriate conformity assessment procedures, in par ticular with respect to Article 5.1.2 of the TBT 
Agreement which stressed that such procedures could not be applied more strictly than necessary.  
The use of accreditation needed to be  examined in more depth.  On Good Regulatory Practice , 
different approaches to regulatory pract ices needed to continue to exist.  There was, perhaps, a need to 
increase the examination of ways in which an in crease in the use of performance based regulations 
could be achieved.  There could also be merit in developing the concept of regulatory cooperation, as 
well as exchanging experiences with respect to re gulatory impact assessments.  The European 
Communities also wished to raise the issue of labelling  with the objective of improving Members' 
mutual understanding on the nature, scope and the impact of measures undertaken in this area.  G/TBT/M/35 
 Page 15 
 
 
78. The representative of Mexico  noted that, with respect to labelling, his delegation had, on 
several occasions, indicated that labelling was either  a technical regulation or a conformity procedure 
depending on the situation.  It was not obvious to Mexi co that there was a need to give a particular 
focus to labelling as such:  it was a measure that was part of a wider universe of TBT measures that could, perhaps, be debated under the heading of  Good Regulatory Practice.  Regarding the issue 
proposed by China on intellectual property rights, th ere was a need to anal yse what actually China 
wished to discuss.  In the view of the Mexican de legation, intellectual property rights were not within 
the remit of the TBT Agreement.  Mexico also wished  to add an item to the list:  the compliance with 
the obligations of the Agreement by authorities at a sub-national regional or local level.  The representative of the European Communities
 supported this suggested addition. 
79. The representative of the United States  recalled, with respect to labelling, that much time had 
been spent on discussing the issue in the context of the Third Triennial Review, and that the result of 
these discussions was contained in paragraph 60 of G/TBT/13 where the Committee had agreed "to 
continue to consider labelling con cerns in its discussions in the context of the implementation and 
operation of the Agreement".  The intention had b een to keep the discussion context specific which 
was the case when Members, on a regular basis, raised specific trade concerns at TBT Committee 
meetings.  Hence, before considering this as a topi c to be debated during the Fourth Triennial Review, 
there was a need for the European  Communities to come forward with a substantiation of why they 
considered that labelling merited pa rticular attention, and why it was not possible for the European 
Communities to address the issue in the context of  the normal agenda of the Committee.  The  
representative of the Australia  associates herself with these comments as well as those put forward by 
Mexico on labelling. 
80. The representative of Switzerland  noted that her delegation supported the proposal to discuss 
conformity assessment procedures.  She also supported the EC proposal on labelling. 
81. The representative of the European Communities  stressed that in the Third Triennial Review 
the Committee had agreed to continue to consider la belling concerns.   It was his view that, given the 
number of specific trade concerns which involve d labelling issues, it was something that the 
Committee needed to discuss.  While  the European Communities prefe rred that the issue be discussed 
in the context of the preparation of the Fourth Triennial Review, the discussion could also be done in the as a follow-up to the Third – in any case the issue could be raised.  
82. The Chairman
 suggested that the Committee consider, at its next meeting, three topics: (i) the 
Implementation and Administration of the Agreem ent, (ii) Good Regulatory Practice and (iii) 
Transparency.  It was so agreed . 
83. The Chairman  encouraged Members to table papers on  the above-mentioned three topics to be 
discussed at the next meeting by 15 May.  In respect of background papers, on Implementation and Administration of the Agreement, Members were  referred to document G/TBT/GEN/2/Rev.1and 
G/TBT/ENQ/26.  On Good Regulatory Practice, a f actual note would be prepared by the Secretariat 
and made available to delegations ahead of the next meeting.  On transparency, it was recalled that the 
Secretariat had already prepared a background not e for the Committee's Fourth Special Meeting on 
Procedures for Information Exchange which was contained in document G/TBT/W/250.  
IV. TECHNICAL CO-OPERATION 
84. The representative of the International Trade Centre
 (ITC) informed the TBT Committee 
about a recent joint publication by the Commonwea lth Secretariat and the ITC entitled "Influencing 
and Meeting International Standards: Challenges for Developing Countries".  He also briefed the 
Committee on the organization of a workshop on th e same topic which would be organized jointly 
with the Commonwealth Secretariat in Geneva fro m 22 to 24 June 2005.  Aside from this Geneva-
based workshop, other national workshops had been  organized on the TBT Agreement in Kyrgyzstan G/TBT/M/35 
Page 16  
 
and Tajikistan in October 2004.  A regional workshop  had been held in Kenya in January 2005 and 
the ITC would be participating in regional TB T workshops under the JITAP in Malawi, from 31 May 
to 2 June 2005, and in Cotonou, from 13 to 15 September 2005.  The TBT Committee was also 
informed about the ITC's Executive Forum which provided a venue for senior public sector decision-
makers and business leaders to debate "best pr actice" in national export strategy design and 
management.
14   
85. The representative of the UNCTAD  reported on the first substantive session of UNCTAD's 
new Consultative Task Force on Environmental Requirements and Market Access for Developing 
Countries (CTF), held on 5 and 6 November 2004 in  Geneva.  He also reported on a stakeholder 
discussion about the EC's draft REACH regulation or ganized with the Foundation for International 
Environmental Law and Development (FIELD) he ld in Brussels on 28 and 29 October 2004.   
Moreover, on 23-24 November and on 2 to 3 D ecember 2004, the UNCTAD had organized national 
policy dialogues on environmental and related health  requirements and market access for horticultural 
products in Phnom Penh, Cambodia, and in Manila, Ph ilippines.  On organic agriculture, the third and 
fourth meeting of the UNCTAD/FAO/IFOAM In ternational Task Force on Harmonization and 
Equivalence in Organic Agriculture had been he ld on 17 to 19 November 2004 in Rome, and on 
28 February in Nuremberg, Germany.  As part  of UNCTAD's UK-DFID -funded project, a regional 
workshop on environmental requirements, mark et access and trading opportunities for organic 
products, jointly organized by the Ministry of External Commerce (COMEX) and UNCTAD, took place in San José, Costa Rica, on 30 to 31 March 2 005.  Regarding forthcom ing meetings, in co-
operation with the UN Economic and Social Commissi on for Asian and the Pacific and the Federation 
of Thai Industries, the UNCTAD Secretariat was planning to hold a sub regional workshop in 
Bangkok, in May 2005, that woul d exchange national experien ces among China, Malaysia, the 
Philippines and Thailand on pro-active adjustment strategies to new environmental requirements for 
electrical and electronic products.
15 
86. The representative of UNIDO  drew the Committee's attention to a report on the "Relevance of 
UINDO Services to the Responses to  the WTO Questionnaire G/TBT/W/178"16  He stressed that the 
UNIDO approach to technical assistance included support to developing countries in improving their 
national quality policies, conformity assessment  systems, standardization and methodology 
infrastructure.  The Committee was also br iefed on the implementation of the UNIDO/WTO 
Memorandum of Understanding (MoU) which establis hed a strategic partnership between the two 
organizations for the purpose of implem enting the Doha Development Agenda.17  In this MoU, it was 
set out that UNIDO's main contribution focused on issues relating to developi ng countries' supply side 
capacity as well as conformity to standards.   
87. The representative of the IEC  updated the Committee on his organization's international 
standardization and assessment activities undertaken since the last meeting of the TBT Committee.18  
He drew WTO Member's attention to the IEC's A ffiliate Country Pogramme , launched in June 2001 
as a direct response to calls for finding ways and means for all WTO Members to use IEC 
international standards, as well as conformity assessment schemes, and to participate in their 
elaboration.   This program was unique in that it was free:  there was no charge and it operated in a full electronic environment, which allowed participan ts to involve themselves in the IEC's technical 
work according to the needs and the resources available.  A workshop dedicated to the Affiliate 
Country Programme, would be held under the auspices  of the IEC General Meeting, to be held in 
Cape Town, South Africa from the 16 to 22 October 2005.   
                                                     
 
14 More information is available at  http://www.intracen.org/index.htm. 
15 More information is available at  http://r0.unctad.org/trade_env/. 
16 This report was made available as a Room Document. 
17 It was pointed out that the Second Joint Progress Report", 8 November 1994, WTO, UNIDO had b een circulated at the last 
SPS Committee meeting as document JOB(05)/28. 
18 The IEC's full report had been issued separately as G/TBT/GEN/16.    G/TBT/M/35 
 Page 17 
 
 
88. The Chairman  noted that a room document was availa ble outlining the Secretariat's planned 
technical assistance activities.   
V. TENTH ANNUAL REVIEW 
A. IMPLEMENTATION  AND  OPERATION  OF THE  AGREEMENT  (ARTICLE  15.3) 
89. The Committee adopted  the Tenth Annual Review of the Implementation and Operation of 
the TBT Agreement contained in document G/TBT/15. 
B. THE  CODE  OF GOOD  PRACTICE  (ANNEX  3) 
90. The Chairman  drew the Committee's attention to the Tenth Edition of the WTO TBT 
Standards Code Directory prepared by the ISO/IE C Information Centre whic h contained information 
received according to paragraphs C and J of the C ode of Good Practice for the Preparation, Adoption 
and Application of Standards in Annex 3 of the Ag reement.  He also drew the Committee's attention 
to two lists prepared by the Secretariat.  The fi rst list, contained in document G/TBT/CS/1/Add.9, 
compiled the standardizing bodies that had accepte d the Code in the period under review.  Since 
4 March 2004, five standardizing bodies from five Members had accepted the Code of Good Practice.  
This included four central governmental standardizing bodies and one non governmental 
standardizing body. No standardizing body had withdrawn from the Code during the period under 
review.  The second list, contained in document G/ TBT/CS/2/Rev.11, compiled all the standardizing 
bodies that had accepted the Code since 1 January 1 995.  Since 1 January 1995, 147 standardizing 
bodies from 106 Members had accepted the Code of Good Practice. 
91. The Committee took note  of the above-mentioned documents. 
VI. OBSERVERS 
A. REQUESTS FOR OBSERVER STATUS  
92. The Chairman  drew the Committee's attention to document G/TBT/GEN/2, circulated on 
4 March 2004, which set out the situation with respect to observership by inter-governmental 
organizations in the TBT Committee.  There were still four organizations whose requests for observer 
status were pending:  the Office International de la Vigne et du Vin  (OIV), the Bureau International 
des Poids et Mesures  (BIPM), the Gulf Organization for Industrial Consulting (GOIC) and the 
Convention on Biological Diversity ( CBD).  He noted that consultations  were still needed on the issue 
of observership at the General Council level. 
B. UPDATING BY OBSERVERS  
93. The representatives of OIML  and the Codex  updated the Committee on relevant work in their 
areas.   These reports are contained in G/TBT/GEN/17 and 18, respectively.  
VII. ELECTION OF CHAIRPERSON 
94. Pursuant to Article 13.1 of the TBT Agreement, the Committee elected  Mr. Margers Krams 
(Latvia) as the Chairperson of the TBT Committee.  
VIII.  DATE OF NEXT MEETING 
95. The Chairman announced that the next regular meeting of the Committee would take place on 
16 to 17 June 2005.   G/TBT/M/35 
Page 18  
 
ANNEX 1: TBT WORKSHOP ON SUPPLIER'S DECLARATION OF CONFORMITY 
21 March 2005
 
 
 1. At the Third Triennial Review of the TBT Agreement, concluded in November 2003, the 
Committee agreed to a Work Programme on conformity assessment to improve Members' 
implementation of Articles 5 to 9 of the TBT Agre ement and, in particular, to promote a better 
understanding of conformity assessment systems.
19  In 2004, the Committe e discussed the issue of 
conformity assessment under three sub-headings:  (i ) Supplier's Declaration of Conformity (SDoC), 
(ii) Accreditation and (iii) Other Issues Related to  Conformity Assessment.  The workshop, held in 
Geneva on 21 March 2005, focused on Supplier's Declaration of Conformity as one approach to 
facilitate the acceptance of conformity assessment results.20  The participation of 93 representatives 
from developing country Members was sponsored by the WTO through the Global Trust Fund.   
IX. GENERAL 
A. OVERVIEW OF THE TBT  COMMITTEE 'S WORK ON SUPPLIER 'S DECLARATION OF CONFORMITY  
2. The WTO Secretariat21 presented a background note cont ained in JOB(05)/30.  It was 
emphasized that this note was intended to assist par ticipants in preparing for the meeting and provided 
an overview of the key issues, submissions and st atements made in respect of SDoC in the TBT 
Committee to date. 
3. The representative of the European Communities  made the point that while there were 
certainly benefits from the use of SDoC (costs fo r third party assessment were avoided), its use also 
entailed some administrative costs.  For instance,  market surveillance coul d be needed in some 
circumstances and there had to be procedures in  place for follow-up in cases of product failure.   
B. THE ISO/IEC  STANDARD ON SUPPLIER 'S DECLARATION OF CONFORMITY  (ISO/IEC  17050) 
1. Statement 
4. The representative of the ISO22, stated that with regard to SDoC, there had initially been an 
ISO guide on SDoC:  Guide 22 (published in 1996).  This Guide had constituted the starting point for 
elaborating a fully-fledged international standard  addressing SDoC:  the ISO/IEC 17050 (published in 
2004).  There were two parts to this  standard.  Part One contained general requirements for companies 
and organisations making their own claims on confor mity.  It covered:  (i) the indication of the 
general responsibilities of the issuer;  (ii) the conten t of the Declaration of Conformity (DoC);  (iii) 
accessibility to the DoC;  (iv) marking and labelling of products with the DoC;  and, (v) the duration 
of the validity of the DoC.  An annex provided an example of the DoC. 
5. In respect of the content of an SDoC itself, the representative of ISO stressed that it had to 
contain, as a minimum:  (i) a unique identification (that related the declaration to a given product or 
process);  (ii) the name, contact address and signature of  the issuer;  (iii) an identification of what the 
declaration covered (for example, product description, type and extent of management system);  (iv) 
the complete list of specified requirements, including standards, that the declaration was based on;  (v) 
the date and place of issue;  and, (vi) any limit ation related to the valid ity of the declaration. 
                                                      
19 G/TBT/13, para. 40. 
20 The full program is contained in G/TBT/GEN/15. 
21 Mrs. Ludivine Tamiotti, Legal Affairs Officer, Trade and Environment Division. 
22 Mr. Allan Bryden, Secretary General, Intern ational Organization for Standardization (ISO).  G/TBT/M/35 
 Page 19 
 
 
6. Regarding marking, it was pointed  out that product marking had to  be done in such a way that 
it would not be confused with an y certification mark (third party conformity assessment).  Moreover, 
such marking had to be traceable back to the issuer.  The issuer had to have procedures in place to re-
evaluate the validity of the declaration of conformity  when:  (i) there were ch anges that affected the 
object’s design or specification (for example the ch anges to the actual product, management system 
etc);  (ii) there were changes to the specified re quirements (including standard s) that related to the 
object of the declaration;  (iii) there were changes in  the ownership or management of the issuer;  (iv) 
there was any relevant information which indicated  that the object no longer fulfilled the specified 
requirements. 
7. Part Two contained guidance that covered the content of supporting documentation.  This 
guidance included:  (i) the description of the object of  the declaration of conformity, including design 
documentation;  (ii) the conformity assessment resu lts, such as a description of the method used to 
determine conformity, the actual results (for example,  audit reports and test results) and records on the 
evaluation of those results which had led to the decl aration of conformity; and, (iii) details of the 
relevant qualification and technical competencies of  those involved in determining conformity.  
Document management was key to the efficiency of any requirement.  Thus, Part Two also related to 
the management of supporting doc umentation in terms of:  (i) traceability for the declaration of 
conformity;  (ii) the availability of any supporting documentation; and, (iii) the retention of supporting 
documents for conformity assessment. 
8. Regarding the use of the SDoC ISO/IEC Standard , the representative of the ISO stressed that 
SDoC could be a cost effective conformity assessment  method.  It could also be used as a method for 
achieving public policy goals when risks associated  with product failure were considered low. 
2. Discussion 
9. The representatives of Antigua and Barbuda  and Grenada  expressed concern about the fact 
that WTO Members, who were not full members of IS O, were limited in their participation in the 
standards development process.  They stressed that  becoming a member of ISO was a costly process 
and many could not afford it.  Thus, they could not directly influence the standards development 
process.  This was troubling as the TBT Agreement made  specific reference to the use of international 
standards and Members were expected to use those standards.   
10. The representative of the ISO  stressed that the minimum membership fee of ISO had to be 
seen against the background of the benefits that  membership offered.  Some 149 institutes or 
organisations responsible for standa rdization in their home countries were currently members of ISO.  
Through their participation in ISO they receive d access to knowledge and expertise which had been 
developed and was contained in the standards th emselves.  Furthermore, ISO produced about 1,100 
international standards per year.  Nevertheless,  the representative of ISO acknowledged that for 
smaller economies it could be difficult to take an active part.  In 2004, ISO had therefore adopted a 
five-year action plan to increase the participation of developing countries in its work.  Since then there 
had been a significant increase in developing country membership. 
11. The representative of the United States  asked for more informati on on the extent to which 
there had been developing country participation in  drawing up the particular standard on SDoC.  
Moreover, the US representative asked how the SDoC-m ark, which needed to be traceable back to the 
issuer, could be distinguished from a certification mark. 
12. Regarding participation, the representative of ISO  indicated that 99 of the 149 members of 
ISO were members of its Conformity Assessment  Committee (CASCO).  Though he was unable to 
provide Members with exact figures regarding the vote on the SDoC standard, he assured the 
Committee that developing countries had had the opport unity to be involved.  Regarding the mark, it 
was clarified that the standard did not indicate that th ere needed to be a mark, but merely that, if there G/TBT/M/35 
Page 20  
 
was a mark associated with it, it would have to be clearly distinguishable from any third party 
certification mark.  The mark for a SDoC would be the mark of the supplier and a statement that the 
DoC had been carried out according to an internationa l standard in terms of the content, the layout, 
etc. 
13. The representative of Mexico
 asked why ISO CASCO had developed the standard on SDoC 
in the first place: had there been a petition or concern on the part of the private sector, or had the 
incentive come from somewhere else?  Also, Mexico  asked whether the ISO, in the course of its 
regular review23, would carry out an evaluation on how many countries had actually adopted the 
standard. 
14. The representative of the ISO  noted that there was an ISO policy on the development of a 
standard when there was a clear recognition of th e need to do so.  The way the ISO formally 
recognized such a need was through national votes on th e creation of a "new work item".  In the case 
of SDoC, the incentive to take the vote had come on the one hand from the private sector, because of 
the various practices of SDoC which could lead to  confusion in the market, and, on the other hand, 
from regulatory authorities, which had also been interested because they  desired some formal 
guidance on how to use SDoC.  Regarding the revi ew, it was confirmed that the review of ISO's 
standards took place at least every five years, unless ther e was a reason to start earlier.  In this context, 
the use of the standard would certainly be checked.  However, it was pointed out that not all countries 
formally adopted the ISO standards.  A number of countries made direct reference to ISO's standards 
by referring to them as "international publications".  Hence, actual use of the document in the market 
could be greater than what would be reflected in a count of the number of national "adoptions". 
15. The representative of Argentina  asked how significantly the use of SDoC contributed to cost 
reduction and whether there were any studies which addressed the average reduction in cost across 
sectors compared to third party evalua tion of conformity (certification). 
16. Regarding the incentive to develop ISO/IEC 17050, the representative of the United States24, 
recalled that the original Guide 22 had been used  successfully for many years via voluntary adoption 
by industry and also by some regulators in the EU , Australia and New Zealand.  The incentive to 
further develop it had come from industry when it was trying to persuade more governments to use 
SDoC.  Some of the feedback that had been given by the governments was that the original standard, 
ISO/IEC Guide 22, was not rigorous enough and that  it had to be updated and revised to add more 
substance to it.  The US industry raised the issu e through its national body to ISO and requested a 
revision to that standard.  Now that more requi rements had been added to make it more rigorous, 
ISO/IEC 17050 gave more confidence to the regulators. 
17. The representative of Guyana  stressed the need for more te chnical assistance in terms of 
implementing the new standard and putting in place th e appropriate regulatory infrastructure.  He was 
concerned that in the absence of such assistan ce, small economies would not benefit from the 
standard.  In fact, the Workshop was probably the fi rst time many developing countries had heard of 
the ISO/IEC 17050.  It was unclear to what extent the standard had been implemented so far and what 
kind of institutional arrangements and infrastructure had been established by those countries that had 
done so. 
18. The representative of China  noted that SDoC could be combined with many other conformity 
assessment methods, such as second and third party eval uation.  In any case, the supplier had to retain 
the choice of deciding which measure should be applied.   
                                                      
23 Which was due in 2009 for ISO/IEC 17050:2004. 
24 Mr David Ling, Hewlett Packard.  G/TBT/M/35 
 Page 21 
 
 
19. The representative of the ISO , emphasized that the choice between the different approaches to 
conformity assessment depended on many factors and,  from a regulators point of view, risk was a 
dominant one.  Moreover, the decision of the regu lator could depend on its capacity to organize 
market surveillance.  It was recognized that th e use of SDoC depended to some extent on the 
possibility to act through market surveillance to avoid fa ulty declarations of conformity.  At the end of 
the day, the central question was how to make sure  that what entered the market complied with the 
requirements placed on that specific product or activit y.  The use of SDoC was not exclusive vis-à-vis 
other forms of conformity assessment:  it was one option. 
X. MEMBERS' EXPERIENCES 
A. THE GOVERNMENT 'S PERSPECTIVE25 
1. New Zealand's Experience with Regard to Electrical Equipment 
(a) Statement 
20. The representative of New Zealand26 stressed that his country's electrical safety regulatory 
system in the field of electrical equipment was fundamentally based on consumer protection and safety and was closely harmonized with the regulatory system of Australia.
27  It had three tiers:  (i) a 
universal requirement for compliance with essen tial safety provisions, which was based on the 
European Low Voltage Directive (LVD) and had b een in place approximately since 1988;  (ii) a 
formal SDoC requirement for a selected range of me dium-risk products (these products were  selected 
jointly with Australia, according to the risk they co nstituted to the public);  and, (iii) for a very small 
range of products that posed a higher risk for a va riety of reasons, a pre-market approval regime was 
in place.  All Australian approvals were accepted into the New Zealand marketplace.  Thus, the two 
countries' regimes for electrical safety were completely harmonized. 
21. New Zealand's SDoC regime had been introduced  in the late 1990s to implement the Trans-
Tasman MRA with Australia;  it re quired the strict pre-market approval for fewer products than 
Australia and the SDoC regime was applied to those products requiring pre-market approval in 
Australia but not in New Zealand.  SDoC existed in New Zealand in the form of four different 
regimes:  (i) a generic regime for supplier liability  that, although it required no formal declaration, 
still held suppliers accountable for safety;  (ii) a fo rmal declaration of compliance regime for electrical 
safety which required the supplier to make a declarati on and keep it on file;  (iii) a gas equipment web 
site, which was based on formal d eclarations; and, (iv) an EMC28 regime where the supplier also kept 
the formal declarations.  That EMC regime was al igned with those of Australia and the European 
Union.  Hence, EU certification was accepted. 
22. In addition, New Zealand operated a perform ance-based regulatory regime to support 
technical innovation.  This added some complications to the SDoC system because it raised the question of which standards might be applied.  If the standard was not clearly mandated, the supplier 
had some flexibility to choose alternative standards to fulfil the performance objectives.  Also, there 
was the question of who could certify to the f undamental safety parameters.  New Zealand was 
currently grappling with this issue, because it had few technical certification agencies that could do so 
and it was unclear how other global and regional standards applied.  New Zealand mainly used 
                                                     
 
25 Speakers in this section were asked to address, inter alia , the following issues:  (i) what reasons and factors (such as risk) 
should be taken into account when deciding to apply SDoC in a par ticular sector (and not in others );  (ii) whether SDoC should be used 
alone or in combination with third party assessment;  (iii) how , in applying SDoC, internationa l standards are taken into accou nt;  (iv) what 
basic institutional and legislative infrastruct ure needs to be in place to use SDoC (f or example in respect of product liabilit y law and 
consumer redress);  (v) how compliance is ensured and what expe rience exists with respect to su rveillance and enforcement (ince ntives that 
could be used to encourage compliance and experiences with pena lties for non-compliance);  (vi) how  the use of SDoC by develope d 
country Members can facilitate imports from developing country Members (G/TBT/GEN/15). 
26 Mr. Peter Morfee, Principal Technical Advisor at the New Zealand Energy Safety Service. 
27 Further information on the New Zealand syst em can be obtained from the web address www.ess.govt.nz.  
28 Electromagnetic Compatibility. G/TBT/M/35 
Page 22  
 
Australian and its own standards, but also accepted so me international and other regional standards as 
being equivalent. 
23. The aim was to achieve an effective reduction in  technical regulatory intervention.  The most 
serious challenge in this regard, when introducing a system of SDoC, particularly where a pre-market 
approval system was being replaced, was how to ju stify failures of compliance in the case of an 
incident of serious consequence.  New Zealand' s Energy and Safety Service had come to the 
conclusion that in order to address this challenge, there needed to be some form of risk balancing 
factor available for implementation as part of the change to a SDoC regime.   
24. Compliance in the New Zealand marketplace was generally good;  this was a consequence of 
an effective post-market monitoring regime which consisted of a number of components.  First, 
sharing of market compliance information with the Australian and other regulators, resulted in very 
low costs for monitoring efforts.  In fact, 90 per cen t of the cost of surveillance in the New Zealand 
marketplace was borne by Australia, the European Uni on and other parties.  Hence, particularly where 
there were common standards, SDoC had some  significant enforcement benefits.  Second, 
surveillance of the market by industry parties:  New Zealand’s Energy Safety Service had found that 
much of its market surveillance was in fact carried out by the competito rs in the marketplace.  It was 
not unusual that suppliers tested their competitor's products and then informed  the regulator about the 
results.  Third, targeted auditing programmes: an Incident Reporting and Inv estigation Scheme as well 
as the responsible attitude of most suppliers contributed to satisfactory compliance.   
25. In New Zealand's experience, SDoC worked well under certain circumstances.  First, one 
precondition was a well-known, internationally aligned and recognized standard for the product in the 
marketplace.  This made it easier for the suppliers to declare exactly what they were complying with.  
Second, regulatory control over the product in a para llel market that used the same standard, including 
the manufacturer’s economy.  In New Zealand’s case, these markets were Australia or Europe.  Third, a good relationship between the manufacturer and the supplier.  There had been some serious 
problems in New Zealand where the manufacturer w as not aware of the standards that the supplier 
was declaring against.  New Zealand’s Energy Sa fety Service agency had also found that large 
companies complied particularly well when they were involved in the actual product distribution (either importation or sale).  Finally, SDoC pe rformed well when functional MRAs with other 
regulators existed and when SDoC regimes had harmoni zed provisions. 
26. However, New Zealand also found that SDoC di d not work well under certain conditions.  In 
particular, when there were alternative global standa rds with deficiencies in safety outcomes, or when 
recognized standards were not available.  In th ese cases, problems tended to arise.  Moreover, 
products which were from supp liers who manufactured to a di fferent voltage or frequency 
requirement constituted a difficulty for New Zealand’s electrical safety regulator.  This occurred when 
the manufacturer was not the supplier or not knowledg eable of the market requirements.  When small-
scale importers and small-scale retailers were involve d, SDoC had also not yielded the desired results. 
27. New Zealand and Australia were reviewing their regulatory regimes and proposed to 
introduce a common mandatory SDoC scheme for all pr oducts.  Currently, Australia did not yet have 
an SDoC regime and New Zealand only applied its regime to a small number of products.  In the 
future, it would be likely that Australia and New Zealand would apply a manda tory SDoC scheme to 
all products, supplemented by a pre-market approval system for high-risk products. 
28. From the New Zealand Energy Safety Service’s experience, there would be merit in having an 
"international regulators' forum".  Also, a global product hazard alert system, which would inform 
regulators of product failures in the marketplace, could also be useful.  In fact, the idea of a global, 
internet-based SDoC system needed to be explored.  It was stressed that New Zealand had a very small and open market – there were few manufacturers in the marketplace and these often served  G/TBT/M/35 
 Page 23 
 
 
niche markets, so most products were imported.  In  a narrow sense, this implied that New Zealand's 
problems in regulating its economy were common to those of developing economies. 
(b) Discussion 
29. The representative of Mexico  stressed that SDoC could not function if there were no well-
developed post-market surveillance mechanisms.  Regarding the three-tier system for electrical 
product safety, Mexico asked on what basis a partic ular system was chosen.  What analysis was 
carried out to decide this?  Mexico emphasized that the relation of trust – in this case between 
Australia and New Zealand – was a very important element. 
30. The representative of Chile  asked for some clarification of the term "pre-market approval". 
31. In response to Mexico regarding the three-tie r system, the representative of New Zealand  said 
that the choice of intervention was based on a number  of risk criteria which were evaluated jointly 
with Australia.  The most important criteria were:  the occurrence of unsatisfactory products in the 
marketplace;  the way in which the domestic market  behaved in terms of compliance aspects;  and, a 
safety assessment of the product itself, taking into  account the product category.  For example, 
electric fence energizers were potentially quite dangerous because they had exposed components on 
them.  Regarding the enforcement infrastructure, it was stressed th at it was possible to use other 
markets' non-compliance information, if their standard s were acceptable and if products were shared.  
Thus, a regime could include enforcement but would still not need a very strong compliance 
infrastructure within its own economy.  New Zealan d had very few test labs and accepted testing from 
other countries around the world.  Regarding "pre -market approval", it was pointed out that New 
Zealand had a mandatory standard:  it required testin g in an accredited testing facility of a sample of 
the product.  This was not a batch testing regime.  Such testing could be carried out in a number of 
internationally accredited testing laboratories worl dwide.  If the product had been found to comply, 
the pre-market approval could be issued by (i) th e regulator in New Zealand or Australia, or (ii) 
agencies with whom New Zealand had an MRA.  He nce, testing could be done within New Zealand 
or within the economy of manufacture. 
32. The representative of Trinidad and Tobago  noted that his country's market was small and 
open so that almost all electrical products were imported.  The problem it faced was that a wide range of products were imported, but in very small quantities each.  The pr oduct standards used were mainly 
international standards for manufacturers.  The re presentative thus wanted to know what type of 
standards the New Zealand regulator used for electrical products.   
33. The representative of Grenada
 asked what had been meant by "small players" in the context 
of SDoC not working well.  She also asked about th e cost of implementing the global alert system that 
Mr. Morfee had recommended.   
34. The representative of Egypt  asked on what basis New Zealand differentiated between 
medium-risk products and high-risk products.  Also, he wanted to know which types of risk were 
addressed by the auditing programmes Mr Morfee ha d mentioned when talking about compliance. 
35. The representative of the United Nations Economic Commission for Europe (UNECE)  
suggested that Members prepare a list of practical problems impeding the use of SDoC in order to further the discussions and find concrete  solutions for particular problems. 
36. Regarding "small players", the representative of New Zealand
 stated that his statement had 
been based on the analysis of cases where problems occurred.  For instance, there had been major 
problems with very high technology, specialist equipment of which only one exemplar each had been 
imported.  The general problem with that kind of small batch imports was that in order to make a 
profit on the deal, companies tended not to spend much time on securing documentation from their G/TBT/M/35 
Page 24  
 
suppliers.  So, in fact, it was the size of the manuf acturing base that mattered.  Nevertheless, even if 
import quantity was small, by networking with ot her regulators, it was possible to find out the 
problems of specific products.
29  It was stressed that most problems occurred when products were 
manufactured in deviation from the us ual standards.  On the issue of the cost of the global hazard alert 
system, Mr Morfee pointed out that the system Ne w Zealand already operated with Australia, which 
had ten different regulators on board, cost very little  – this was simply an e-mailing list and did not 
need a large database.  Also, each economy kept tr ack of all its hazard information and posted it on a 
web site where other regulators could access it.  
2. Market Surveillance Mechanisms for I ndustrial Products in Chinese Taipei30 
(a) Statement 
37. The representative of Chinese Taipei31 explained that for each product that fell under 
mandatory SDoC, the Chinese Taipei Bureau of Standards, Metrology and Inspection (BSMI), 
announced which standard applied a nd which technical documents were to be prepared.  Products that 
posed low safety risks, such as computer component s, had been selected as the first group for which 
SDoC had been implemented.  The testing which w as required before making a declaration had to be 
carried out either by the BSMI itself or by testi ng laboratories it recognized.  A complete SDoC would 
hence include necessary technical documentation as well as a signed declaration of conformity regarding the applicable standards.  Moreover, the t echnical file had to be retained for at least five 
years after the product was taken off the market.   
38. Should the BSMI carry out a check of the product in the course of market surveillance, the 
SDoC would have to be presented to the BSMI wi thin 24 hours;  for the technical documents the 
time-limit was ten days.  Specialized personnel co llected information on non-compliance, analysed 
risk factors, conducted product checks, supervi sed the recall or improvement of products by 
manufacturers and provided information and advice to  consumers and suppliers.  Market surveillance 
took place where products were displayed and sold, at production or storage sites as well as in locations where the products were in use, such as work places.  Market surv eillance plans were drawn 
up on an annual basis.  These were elaborated by  taking into account risk assessments, lessons-learnt 
from previous surveillance activiti es and the characteristics of products and product areas.  Also, 
information on compliance was gathered from the pub lic via volunteers that were selected to help 
monitor consumer goods and also from consumer protection groups. 
39. The implementation of market surveillance in Chinese Taipei entailed drawing up inspection 
plans, education programmes for manufacturers an d distributors, sample purchases in the market 
place as well as sampling from the production or storage sites.  Sampling was done in order to check 
whether commodities had passed the required tests, wh ether the appropriate mark or label had been 
affixed and so as to monitor imposed recall time limi ts or violations of disp lay prohibitions.  Penalties 
for non-compliant products were bans on production, sale or import, requiring corrective action within 
a time-limit, or fines.  
40. Two market surveillance plans had been impl emented in 2003 and 2004, respectively.  
Appearance checks (whether the mark was affixed or  not) yielded a non-compliance rate of ½ per cent 
in 2003 and one of 6 per cent in 2004.  Sample T esting (regarding the declaration of conformity, 
technical documentation and EMC testing) revealed  a non-compliance rate of 47.7 per cent and 24 per 
cent respectively.  Hence, Chinese Taipei's experien ce with SDoC had not been particularly successful 
as the non-compliance rate was relatively high co mpared to the rate under other conformity 
                                                     
 
29 For instance, a multinational manufacturer was unlikely to produce only twenty or fift y items for a one particular economy.  
This meant that there would probably be thousands or tens of th ousands in other markets.  If a regulator could find out where w ere  and what 
problems they caused, a small im port quantity would not matter. 
30 For more information, consult:  http://www.bsmi.gov.tw.  
31 Mr. Bing-Yuan Liou, Senior Specialist,  BSMI, Ministry of Economic Affairs.  G/TBT/M/35 
 Page 25 
 
 
assessment procedures.  Factors that had possi bly affected the success of SDoC included the 
completeness of the legal framework, how manufact urers interpreted that legal framework, the 
government's financial, human, and informati onal resources, consumers' awareness about and 
confidence in product certification, a lack of confidence on the part of the regulators, or the effectiveness of the market  surveillance mechanism. 
41. The representative of Chinese Taipei stressed the need to share experiences on how post-
market surveillance was conduced in an effective way.  In his opinion,  market surveillance was key to 
a successful SDoC regime:  meaning one that ensure d the safety of consumers and yielded benefits for 
manufacturers through deregulation and simplified procedures. 
(b) Discussion 
42. The representative of India
 asked how it was possible that in 2003, for the "sample testing" a 
non-compliance rate of close to 48 per cent had been discovered given that a ½ per cent non-compliance rate in the "appearance checks" had po inted to almost full awareness about the SDoC 
requirements on the part of the suppliers and impo rters.  He also asked what the increase in non-
compliance in the "appearance check s" from ½ per cent to 6 per cent between 2003 and 2004 was due 
to.   
43. The representative of Barbados
 asked how the length of time for testing and inspection of 
products had been decided.  Barbados had come across cases where a trade-off had to be made 
between thorough, lengthy testing on one hand and no t impeding business development on the other.  
On penalties for non-compliance he noted that smal l countries, such as his own, sometimes had no 
choice other than completely banning a non-comp lying product from the markets because foreign 
manufacturers were not always willing to make adju stments to products for a country that constituted 
such a small share in their revenues.  Taking that decision was, however, not necessarily in the overall 
interest of the country. 
44. The representative of the United States  asked if penalties had actually been imposed by the 
authorities in detected cases of non-compliance. 
45. The representative of Chinese Taipei  confirmed that a company that had actually affixed an 
SDoC label showed that it understood what the government's requirements were.  In assigning 
penalties, his agency distinguished between offe nces of labelling require ments and non-compliance 
regarding standards.  A fine was applied if non-c onformity with standards was detected, while faulty 
labelling was dealt with by merely imposing a time li mit for corrective action.  Turning to Barbados, 
it was stressed that Chinese Taipei required imports to  comply with government rules.  If this was not 
the case, importation would be held up.  In the case where the manufacturer of a non-compliant 
product was located in Chinese Taipei, the BS MI would immediately stop production. 
46. The representative of Antigua and Barbuda  noted that this second presentation had once again 
confirmed that SDoC would only work well in ec onomies with sufficient resources for implementing 
the necessary infrastructure.  Similarl y, the representative of St. Lucia  noted that in the experience of 
Chinese Taipei, there had apparently been instances  where suppliers were declaring conformity to 
standards which the manufacturers themselves were unaware of.  Hence, the emphasis on market surveillance.  Yet this was costly – and additio nal procedures themselves could constitute unnecessary 
barriers to international trade. 
47. The representative of Japan
 inquired if the BSMI disclosed information on non-compliance 
rates, such as the result of the sample testing in 200 3, to the public and, if so, whether it also informed 
consumers about which products were affected  and who manufactured or imported them.  
Furthermore, Japan wanted to know on what lega l basis market surveillance was carried out and 
whether the BSMI was founded on a form of general product safety law. G/TBT/M/35 
Page 26  
 
48. The representative of Chinese Taipei
 said that enforcement of SDoC involved considerable 
human resources but that the BSMI was, nevertheless , coping.  In fact, type testing and SDoC had 
officially been introduced in the course of a ve ry rapid transition from batch inspection as early as 
2000, which had caused some resource probl ems for Chinese Taipei's regulators. 
3. The Brazilian Experience with Suppli er's Declaration of Conformity 
(a) Statement 
49. The representative of Brazil32 explained that INMETRO (the Brazilian National Institute of 
Metrology and Quality) was responsible for the Brazilian Conformity Asse ssment System and was 
also Brazil's official accreditation body.33  Brazil employed all the traditional means of conformity 
assessment such as certification, supplier's declarat ion, labelling, inspection and testing.  Depending on 
the applicable method, monitoring or pr oducts in the market could be done in two ways:  by inspection  
carried out by a network of public bodies under th e supervision of INMETR O, which established 
inspection procedures and provided training for the in spectors.  INMETRO verified that products bore 
the Brazilian conformity mark.  In the event of i rregularities, the inspectors could seize products or 
prohibit their sale as well as impose fines (up to  around $US 1 million).  The other approach was 
market surveillance,  which involved the periodical testing of  samples of confor mity-assessed products 
collected at the point of sale.  If non-conformance was detected, an analysis of the cause would be 
performed. 
50. It was stressed that SDoC was applied in Brazil only to products or services that posed 
medium to low risks to the health or safety of the consumer or the environment.  The objective was to 
ensure, with an adequate level of confidence and wi th the lowest cost to society, that products and 
services were compliant with the requirements of standards and regulations.  In adopting SDoC,  
maturity of the consumer relations, record of qu ality in the sector, the related costs as well as the 
international standard ISO/IEC 17050 had been  taken into account.  INMETRO's regulations 
stipulated that products which were subject to c onformity assessment based on SDoC needed to be 
periodically verified via market surveillance – and more frequently compared to products subjected to 
third-party conformity assessment.  A first verifica tion would normally be performed no later than six 
months after the introduc tion of the product and subsequent verifications  would take place at least 
annually thereafter. 
51. It was stressed that SDoC was being implemen ted gradually in Brazil and was currently used 
in the following sectors:  disposable cigarette light ers;  installation of vehicular natural gas systems 
(VNG);  angle iron made of hot-rolled steel;  and,  welded or seamless, carbon or micro-alloyed steel 
tubes for use in the structure of transmission towers .  Applying SDoC to fire extinguisher powder and 
plastic chairs had already been r ecommended by feasibility studies.   
52. Brazil's market surveillance programme gave priority to the assessment of requirements 
related to health, safety and the environment.  Pr oducts would be collected at the retail level and 
submitted to INMETRO-accredited testing laboratories.   A market survey regarding points of sale in 
the country would be conducted at the same time in  order to identify and chart the distribution of 
manufacturers, importers, brands and models.  This survey ensured that the sample was representative 
regarding its size and its regional distribution.  Th e most recent results for some of the products under 
the SDoC regime are set out in Table 1. 
                                                      
32 Mr. Alfredo Lobo, Director of Quality at the Brazilia n National Institute of Metrology and Quality (INMETRO). 
33 The Brazilian Conformity Assessment Syst em is a sub-system of the National Sy stem of Metrology, Standardization and 
Industrial Quality (SINMETRO). SI NMETRO is ruled by the guidelines of the Natio nal Council of Metrology, Standardization and 
Industrial Quality (CONMETRO). The National In stitute of Metrology, Standardization an d Industrial Quality (INMETRO) is the cen tral 
executive body of SINMETRO. It manages the conformity assessment programmes and is also the official accreditation body in Braz il.  G/TBT/M/35 
 Page 27 
 
 
Table 1 
Market Surveillance – Supplier's Declaration Results 
Name of the Product Non-Conformity 
 Disposable Cigarette Lighter 0% 
 Installation of Vehicular Natural Gas Systems 14.1% 
 Angle Iron made of hot-rolled steel 0% 
 
53. In Brazil, there was a trend towards a highe r incidence of non-conformities in services 
compared to goods.  However, the results presented in  the chart were similar to those made in third 
party assessments.  In general, Mr. Lobo considered the use of SDoC in Brazil to have been very 
positive.  He noted that Brazil did not yet have any experience regarding the use of SDoC by developed 
countries in order to facili tate imports from Brazil. 
(b) Discussion 
54. The representative of India  understood that Brazil used specialized software for risk 
assessment and asked which parameters were used to measure costs and benefits. 
55. The representative of Haiti  asked if, in the case of a product not conforming with the quality 
standards, whether an importer or exporter should turn to the producer of that product or directly to 
INMETRO, in the case of Brazil.  
56. The representative of Brazil  stated that Brazil's risk analysis methodology used information 
related to the sociological, technical and economical  aspects to select whether first, second or third 
party conformity assessment was to be employed. 
4. The Canadian Experience with SDoC  in the Telecommunications Sector 
(a) Statement 
57. The representative of Canada34, noted that there had been th ree main areas of consideration 
when considering the use of SDoC in the Canadian  telecom sector.  First, the maturity of the 
technology and the industry determined how experien ced the regulator and the companies were in a 
particular field.  Second, low risk of the produc ts covered was important.  Regarding the telecom 
sector, this meant low probability of interference or damage.  Third, the regulator's ability to monitor 
and enforce its regulation was key to the success of SDoC.  This entailed the need for an appropriate 
legal framework which was conducive to the verifi cation and enforcement of product compliance.  
Also, the regulator needed to have the intern al capability to carry out the monitoring activities 
properly. 
58. In the Canadian telecom sector, SDoC was u sed for four product groups: terminal equipment 
(meaning telephone, facsimile, etc.), radio equipment (a lbeit only with very low risk of interference), 
broadcasting equipment (mainly on the receiving e nd, e.g. TV sets) and interference-causing 
equipment (anything able to cause unintended radi ation or radio frequency interference, such as 
computer equipment or spark ignitions).  Each product group had different requirements (Figure 1, 
below).  However, all schemes included mandatory  marking.  In none of the programmes were the 
requirements combined with any certification requirements:  it was always either certification or 
SDoC. 
                                                      
34 Mr. Claude Beaudoin, Industry Canada, Manage r of Interconnection Pla nning and Coordination. G/TBT/M/35 
Page 28  
 
 
Figure 1 
Industry Canada    http:/ / strategis.ic.gc.ca
Industrie Canada   http:/ / strategis.ic.gc.ca9 March 2005Industry Canada Telecom
SDoC Programs
not requirednot requirednot requiredrequiredCanadian 
Representative
not required not required•Interference Causing 
Equipment
•Low Power License-
Exempt Radio Equip-
ment (extremely limited)•Broadcasting equipment 
(Receivers)•Terminal EquipmentEquipment Type
not required not requiredrequired not requiredrequired requiredRegistration 
requirementRecognized 
Testing 
Laboratory
 
 
59. For terminal equipment, SDoC had been introd uced in 2002.  It had been based on ISO Guide 
22 as the much broader ISO/IEC 17050 did not exist at the time.  The program required: registration with Industry Canada;  that testi ng be performed by laboratories re cognized by Industry Canada;  the 
marking of equipment (marking had to include the registration number and other information such as 
the model number and the manufacturer); and, a Cana dian representative for audits and enquiries by 
the regulator.  It was noted that the WTO ITA Committee
35 had developed four generic forms of 
SDoC regimes for EMC-EMI36 products.  In this respect, he pointed out that the Canadian regime for 
terminal equipment was "Type 1";  for broadcasting equipment it was "Type 3"; and, for interference-
causing equipment "Type 4".  In Canada, and for th e Telecom sector, there was no implementation of 
what the paper referred to as "Type 2".37 
60. The importance of good post-market surveillance was highlighted.  Mr. Beaudoin explained 
that when the move had been made from certifica tion to SDoC in 2002 for terminal equipment, 
employees in the regulator's certification engineer ing bureau (pre-market ac tivities) had been given 
the responsibility of acting as a national centre to c oordinate the monitoring programme (post-market) 
for all the equipment that was subjected to SDoC.  Fines of up to Can$25,000 for individuals, and up 
to Can$250,000 in the case of corporations, could be imposed for non-compliance.  Theoretically, 
even imprisonment was possible but in most case s the response to non-compliance by the suppliers 
was cooperative and punishment was a last resort. 
61. On the results of verification of compliance, it was noted that each year, about 2 per cent of 
the roughly 2,000 newly introduced products would be audited and that the level of compliance since 
2002 had been around 95 per cent.  Cases of non-complia nce were mostly of administrative nature, 
e.g.  faulty marking.  Some audits were also c onducted on the base of complaints from a competitor or 
consumer.  In the case of terminal equipment, ma rket surveillance was facilitated by the registration 
system which gave the regulator detailed informa tion about the products in the market and provided 
                                                      
35 Information Technology Agreement.  It is noted here that the Committee of Participants on the Expansion of Trade in 
Information Technology Products formally adopted, on 24 February 2005, "Guidelines for EMC/EMI Conformity Assessment Procedures ".  
These are contained in G/IT/25, 17 February 2005.  For more background, see also G/TBT/M/33/A dd.1, 21 October 2004, paras. 192- 197.  
It is noted here that the representative of  Chinese Taipei informed Memb ers that Chinese Taipei was in the process of implement ing what 
those guidelines classified as a "Type 3" SDoC regime. 
36 Electromagnetic Compatibility, Electromagnetic Interference. 
37 The representative of Chinese Taipei info rmed Members that Chinese Taipei was in  the process of implementing what, under 
those guidelines, were classified as a "Type 3" SDoC regime.  G/TBT/M/35 
 Page 29 
 
 
contact information.  Equipment was selected fo r audit purposes based on interference investigation, 
complaints from competitors or on a random basis. 
62. In concluding the representative of Canada st ressed that converting to SDoC did not mean 
giving up regulation.  However, communicating prop erly with the industry was of major importance 
when introducing an SDoC regime.  The use of SDoC could be facilitated by using international 
standards, adapted to different levels of risk.  The system could be implemented progressively.  
Moreover, SDoC was consistent with the TBT pr inciples, and, compared to the time-consuming 
involvement of a certifier, time-to-market could be significantly reduced.  In general, Canada 
considered that SDoC functioned well. 
(b) Discussion 
63. The Chairman  asked why a requirement for a Canadian  local representative had been included 
in the newest programme for terminal equipment (paragraph 59, above).   
64. The representative of Canada  replied that, as a regulator, the primary concern was about risk 
and, for that reason, when starting the most recent programme, the idea had been raised to include the 
local representative requirement.  However, sin ce it was considered an evolving programme and 
countries aligned their requirements with each others , this requirement could be changed or removed 
in the future. 
65. The representative of the De mocratic Republic of Congo  asked how the distributor and the 
manufacturer cooperated when taking correctiv e action in the case of non-conformity.   
66. The representative of Canada  noted that in most cases, once notified, a supplier or distributor 
would quickly comply and remove the product off the market voluntarily. 
5. The Korean Experience with SDoC in the Automotive Sector 
(a) Statement 
67. The representative of Korea38 began by noting that in his country only vehicles that met safety 
standards in conformity assessment procedures were  licensed to operate.  As Korea's automobile 
imports and exports had risen rapidly since the 1990s , differences in safety standards and conformity 
assessment procedures had become an important a nd growing problem.  Manufacturers at home and 
abroad had felt an increased burden of complying with  additional certification costs.  Complaints from 
foreign automobile manufacturers and looming trade concerns had persuaded the Korean government 
to take action.    
68. First, Korea had harmonized its safety standards with international standards by joining the 
UN-ECE W2939, which was the leading body in international harmonization of vehicle safety 
standards (Figure 2, below).  Korea also bega n participating in the APEC road transport 
harmonization project in forming cooperative rela tionships with other countries (the European 
Communities, the United States and China).  In 2003 , in an effort to rationalize its conformity 
assessment procedures in the automotive sector, Korea had switched from type approval to SDoC.  However, prior to adopting SDoC in 1992, Korea ha d introduced a recall system.  This had proved 
very useful in establishing an efficient quality cont rol system for manufacturers, and, it had the added 
benefit of increasing consumer awareness.   
                                                     
 
38 Mr. Woo-Jin Jung, Deputy Director, Ministry of Cons truction and Transportation (MOCT), Republic of Korea. 
39 It was pointed out that the UN-ECE W29 was originally a group working to harmonize safe ty standards among European 
Countries. In 1995, it opened itself to non-European countries. W 29 included two Agreements, one from 1958 and the other from 1 998.  In 
2001, Korea acceded to the 1998 Agreement and in 2004 to the 1958 Agreement.  W29 had six expert groups under it that establish ed 
vehicle standards, exchanged information an d promoted international co-operation. Ther e was a special APEC group within W29 nam ed 
RTHP, which Korea had attended since 1996. G/TBT/M/35 
Page 30  
 
 
Figure 2 
International Harmonization Trend
1958 Agreement
1998 Agreement6 Expert 
Meetings
GRE, GRSP, GRRF 
GRSG, GRPE, GRBUN/ECE
WP29
Harmonization 
of 
Safety StandardsAPEC
(RTHP)International CooperationInternational CooperationExchange InformationExchange InformationRule-making ActivitiesRule-making Activities
 
 
 69. In Korea's view there were several important benefits to using SDoC.  Cost savings could 
enhance market flexibility and enable the government  to cut its budget without  undermining its policy 
objectives.  International trade of automobiles ha d been significantly facilitated and there was no 
discrimination of geographic location.   
70. The necessary steps to declare conformity in th e Korean regime were simple.  First, the 
manufacturer or importer had to register the testi ng facilities with the Ministry of Construction and 
Transportation (MOCT).  After successful testing, the manufacturer would declare compliance and 
affix the relevant labels to the automobiles.  As a last step, the MOCT needed to be notified of the 
vehicle model's specifications.  In the Korean expe rience, the prerequisites for the adoption of SDoC 
included the level of technical know-how of the ma nufacturers, the degree of consumer awareness and 
the existence of an effective market surveillance me chanism.  With respect to the latter, an active 
consumer role was an important component.   
71. It was stressed that especially in relation to su ch safety risks as in the area of automobiles, it 
was absolutely necessary to ensure compliance by the manufacturers.  This was done through a recall 
system.  Vehicles were recalled when they did not comply with all the required safety standards or a 
safety related defect was found.  This process worked in a number of ways:  In a compliance test a 
vehicle was randomly selected
40 and tested.  Alternatively, a defect investigation was initiated when a 
vehicle was suspected of having defects because of consumers' complaints or reports from vehicle 
inspection centres.  If a non-compliance was identifie d, the manufacturer would be given a chance to 
present a defence and a recall order would be given.  Also, voluntary recall by the manufacturer was possible if the manufacturer found non-compliance or  defects.  Manufacturers could be fined up to 
$US 1 million. 
72. The outcome of the recall system since 1992 had been a surge in the number of recalled 
vehicles (Figure 3).  According to Mr. Jung, reasons  for this included enhan ced consumer awareness 
as well as active monitoring.  Most of the recalls were due to safety defects rather than non-
compliance with safety standards.  Moreover, most  recalls had been voluntarily conducted by the 
manufacturers.  Mandatory recalls by the government were rare.   
                                                     
 
40 Vehicles were usually selected fr om models with high sales volume.  G/TBT/M/35 
 Page 31 
 
 
 
Figure 3 
Volume of Recalled Vehicles in Korea
0500,0001,000,0001,500,0002,000,0002,500,000
' 9 2' 9 3' 9 4' 9 5' 9 6' 9 7' 9 8' 9 9' 0 0' 0 1' 0 2' 0 3' 0 4Volume
 
 
(b) Discussion 
73. The representative of Argentina  asked whether the SDoC covered, apart from the issues 
related to safety requirements, also pollution-rela ted issues and if those were also enforced.   
74. The representative of Korea  confirmed that the SDoC included pollution standards.   
75. The representative of the United States  asked whether – given the success of SDoC in the 
automotive industry – Korea would apply this schem e to other industry sectors, such as information 
technology (for electromagnetic interference) or privat e safety, where there was less risk than in the 
automotive industry.   
76. The representative of Korea  confirmed that his government would be implementing SDoC for 
electronic products in 2006. 
77. The representative of Guyana  asked if SDoC applied to used vehicles being exported to 
Korea. 
78. The representative of Malaysia  asked about the apparent contradiction in that Korea had 
introduced SDoC even though it was a member of the 1958 Agreement of UN-ECE W29 which required third-party certification.   
79. The representative of Korea
 clarified that in order to adhere to the 1958 Agreement, Korea 
ran a two-tier programme.  Although SDoC was used for vehicles for domestic use, vehicles for 
export  would still be certified by the Korea Government. G/TBT/M/35 
Page 32  
 
6. The EC Experience with SDoC in the Electrical and Mechanical Sectors
41 
(a) Statement 
80. The representative of the European Communities42, Mr. Georg Hilpert from the European 
Commission, recalled that Article 28 of the EC Tr eaty stipulated free movement of products on the 
European internal market.  It prohibited all quant itative restrictions on imports and all measures 
having equivalent effect between member States.  Article 95 of the EC Treaty provided for technical 
harmonization of European legislation. These two Articles were the basis of the so-called "New 
Approach" Directives such as the Low Voltage Dir ective or the Machinery Directive.  The main 
elements of the New Approach Directives were conformity assessment, technical documentation, "CE" marking and – most importantly – market surveillance.  
81. The Low Voltage Directive (LVD) 73/23/EEC
43 had been adopted by the European Council 
on 19 February 1973 with the aim of harmonising the laws of the Member States relating to electrical 
equipment designed for use within certain voltage limits.  In 1993, that Directive was amended by 
Directive 93/68/EEC(5), the so-called "CE marking Dir ective", solely in respect of the procedures for 
conformity assessment and conformity marking. Th e objective of this amendment was to align the 
provisions concerning conformity assessment and th e CE marking of electrical equipment on those 
introduced for the "new approach" directives. 
82. It applied to all electrical equipment designe d for use within the "low voltage" range.  The 
LVD was a so-called "total harmonization" and "total safety" directive.  "Total harmonization" meant that there were no other legal requirements allowed in Member States;  "total safety" meant that the directive regulated all safety aspects of products wh ich it covered.  Under the LVD there was a large 
system of European electro-technical standards;   of the approximately 700 European harmonized 
standards, 75 per cent were identical or at  least based on international standards. 
83. Regarding the conformity assessment under the LVD, the manufacturer had two possibilities.  
The manufacturer could either apply his own technica l specifications to comply with the directive or 
he applied the relevant European harmonized standa rds.  This gave the manufacturer the opportunity 
to find alternative ways to fulfil the requirement of the directive, and, therefore, facilitated innovation.  
When applying the harmonized standards,  however, a manufacturer had to ensure and declare  that his 
product fulfilled the requirements of the LVD.  Annex 4 of the LVD mentioned the procedure of 
internal production control.  The manufacturer ha d to prepare a technical documentation – which was 
to be kept for ten years – that would enable the assessment of conformity of the electrical equipment to the requirements of the directive.  The manufacturer 's declaration of conformity (SDoC) was part of 
that technical file.  In the case of LVD, the SDoC did not need to be delivered with the product under 
the LVD.  The completion of the conformity assessment process was signalled by the mandatory CE 
marking which was affixed before the product was placed on the market.  In cases where there was 
more than one applicable directive, the SDoC n eeded to refer to all applicable directives.   
84. Regarding SDoC in the EC, this had to identify:   (i) the directives according to which it had 
been issued, (ii) the manufacturer or his author ized representative, (iii) the "notified body", if 
applicable, (iv) the product itself, and – where a ppropriate – a reference to harmonized standards or 
other normative documents which ha d been applied.  For electrica l products covered by the LVD, 
there was only SDoC.  Hence, there was no third part y involvement in the electrical area even though 
the products could represent a high-risk (LVD cove red voltages up to 1000 volts).  However, over the 
last 20 years, fatal electrical accident numbers in Europe had fallen dramatically.  Hence, in the view 
of the representative of the European Communities, having third-party involvement did not 
                                                     
 
41 For more information see:  http://europa.eu.int/comm./ent erprise/electr_equipment/lv/index.htm, /comm./enterprise/ 
newapproach/legislation/guide/legi slation.htm or /comm./enterpr ise/networks/eic/eic.html. 
42 DG Enterprise and Industry, mechanical and electrical engin eering and radio and telecom te rminal equipment industries. 
43 OJ No L 77, 26.3.1973, p. 29.  G/TBT/M/35 
 Page 33 
 
 
necessarily increase the safety of products.  In contrast, the Machinery Directive provided for self-
declaration in some product areas and for third-part y certification in high risk areas and the Pressure 
Equipment Directive had an even larger variety of different conformity assessment procedures with third party intervention.   
85. It was stressed that neither SDoC nor third-pa rty certification systems worked without market 
surveillance.  On the issue of liability, it was st ressed that the manufacturer always bore the burden 
(Figure 4, below).  According to the European Liability Directive (1999/34/EC), certification bodies did not carry any product liability. 
 
Figure 4 
Geneva, 21 March  2005 (16) 
 European CommissionManufacturer´s Liability
European Liability 
Directive 1999/34/EC
Enforced
by the member statesCertification bodies
do not carry any
liability
Additional 
national regulationsRegulations and 
jurisdiction in 
all other countriesManufacturers
a l w a y s
liable !
Manufacturers
a l w a y s
liable !
 
 
(b) Discussion 
86. The representative of Egypt  asked, given the statement that third-party conformity assessment 
was not necessarily needed for high-risk electro-tec hnical products, what other factors could affect the 
choice of conformity assessment method.  Also, was it correct that products destined to Europe from 
developing countries would not need third-party co nformity assessment if they were not included in 
the directive's listing of products for which th ird-party conformity assessment was mandatory?   
87. The representative of the European Communities  stated the need for third-party intervention 
was not necessarily correlated the level of risk. With  respect to safety of electrical appliances there 
was already a long history and tradition of standard ization in Europe which had lead to many well-
established technical rules in the member States. Wh en drawing up the LVD th e application of these 
rules without third party intervention had been rec ognised as one way to comply with the directive’s 
safety provision.  For other areas however, such as the Machinery Directive, there was not much 
experience and only a few technical rules in the Memb er States, and, therefore, it had been decided by 
the legislator when drafting the Machinery directiv e to require third-party certification for high risk 
machinery.  
88. The representative of Argentina  asked whether, based on the EC perception that SDoC did not 
necessarily affect product risk, it could be expect ed that the European Communities would introduce 
SDoC into other sectors in which it had broad regul ator experience.  Secondly, she asked whether the 
requirement for a legal representative continued to exist for areas where there were mutual recognition agreements. G/TBT/M/35 
Page 34  
 
89. The representative of the European Communities
 replied that the European Communities was 
in the process of revising the "New Approach" a nd that this revision could also affect existing 
conformity assessment procedures.  The objective was to eliminate differences between the various directives as far as possible as well as to reduce, if appropriate, the number conformity assessment procedures.  Moreover, new mutual recognition ag reements with non-EC countries were not a high 
priority because the European Commission had realized  that they did not help to achieve worldwide 
technical convergence.  Rather, they  cemented existing legislation.  
90. The representative of Mexico
 asked what exactly had been mean t in terms of SDoC incurring 
lower costs:  was this in terms of the product price or the costs in implementing that type of system?  
Clearly, if conformity assessment cost were to be borne by the government, there would be a transfer 
away from the manufacturers, which imposed costs on the consumers via taxation. 
91. The representative of the European Communities  reiterated that it was the manufacturer who 
was responsible for ensuring that his or her produ ct was compliant with the requirements of the 
directive.  This was done through the application of either harmonized standards or internal technical 
specifications.  Since SDoC was merely a document on which the required information needed to be 
set out, costs were low.  The costs for the conformity assessment itself were of course higher but had 
to be borne by the supplier, not the government – and these costs we re lower than the costs incurred 
from third-party conformity assessment.  Regarding the costs for member States, the SDoC regime could be costlier for the administration , because a functioning market surveillance system was 
needed.  However, market surve illance was necessary for all different types of conformity assessment 
procedures, not just for SDoC. 
92. Regarding market surveillance, the representative of Malaysia
 asked whether there was any 
formal mechanism for coordination and co-operatio n between member States, such as information-
sharing, and, if so, how it was organized. 
93. The representative of the European Communities  explained that European market 
surveillance authorities met at least  twice a year in a so-called ad ministrative co-operation working 
group to coordinate their activities.   
94. The representative of Kenya  asked if there was any possib ility of information-sharing 
between developed and developing c ountries with regard to market-surveillance so that countries with 
weak surveillance infrastructures could provide th eir consumers with safe products while introducing 
SDoC. 
95. The representative of the European Communities  reiterated that, in his view, even with third-
party intervention necessitated market surveillan ce infrastructure, such as testing facilities. 
96. The representative of Guyana  asked about the occurrence of counterfeit CE markings on 
electrical products due to the implementation of SDoC.   
97. The representative of the European Communities  noted that market surveillance authorities 
could not identify counterfeit products, they needed the help of manufacturers to do this.  The main 
concern was compliance  with the safety requirements. 
98. The representative of Trinidad and Tobago  wished to know more about the "CE" marking. 
99. The representative of the European Communities  stated that the "CE" marking was essentially 
a statement from the manufacturer that it had fu lfilled all the requirements which were necessary 
under the directive.  It was not a quality mark.   
100. The representative of Chile  asked what function the "notified bodies" in the context of SDoC.  G/TBT/M/35 
 Page 35 
 
 
101. The representative of Egypt  asked what incentives existed for suppliers to comply with the 
requirements, besides liability?  In addition, as the SDoC subject-matter was a TBT implementation 
issue44, he asked how developing countries exporting to  markets of developed countries could benefit 
from such a mechanism.  Technical assistance needed to be provided to  developing countries so as to 
enable the setting up of needed regulatory and phys ical infrastructure (such as market surveillance 
systems).  The representative of Egypt also asked what kind of special and differential treatment 
(S&D) could be granted to developing c ountry exporters in the area of SDoC? 
B. THE  MANUFACTURER'S  / SUPPLIER'S  PERSPECTIVE45 
1. Transition to SDoC in the IT/Telecom Sector in the European Communities46 
(a) Statement 
102. The representative of LM Ericsson , Mr. Per Döfnäs47, explained how two fundamental factors 
had contributed to the simplification of product regul ation in the European Union.  One had been the 
realization of the EU Common Market and the other had been the move to SDoC on product 
regulation.  The latter had significantly reduced t echnical requirements and simplified administrative 
proceedings when launching new products. 
103. Efforts to establish a common internal market in  the European Communities had started in the 
late seventies with the replaceme nt of various national requirements by EC-wide requirements and 
alignment with international standards.  From the manufacturer's perspective, this meant one set of 
requirements instead of the 15 (currently 25) nationa l ones.  The effect had been quite drastic:  the 
overall time-to-market (for a product) had been significantly shortened as there was no longer any need to adapt the products to the different count ry-specific regulations.  Previously, technical 
requirements had been highly detailed and difficult to understand, which meant that companies had to 
employ scarce expert resources, and parallel appr oval was impossible: products were introduced 
successively (in one country at a time).   
104. The simplification process regarding technical requirements began in 1973 with the Low 
Voltage Directive (LVD) (previous speak er).  For the first time, it listed only safety  objectives and did 
not stipulate technical requirements as such.  Then, the "New Approach" regulatory technique, 
developed in 1985, had provided for a separation of  policy objectives (such as safety, interference 
problems) from the technical standards or techni cal means to achieve those objective.  The LVD 
(previous speaker) had paved the way (in administ rative terms) because it required no third-party 
intervention.   
 
                                                     
 
44 The latest report on the TBT Committee's two outstanding implemen tation issues, including SDoC ("T iret 34"),  is contained in 
G/TBT/W/191, 23 October 2002. 
45 Speakers in this section were asked to address, inter alia , the following issues:  (i) the reasons why manufacturers may prefer 
SDoC;  (ii) the main problems encountered by the manufacturer in implementing SDoC;  (iii) any specific problems relevant to SM Es. 
(G/TBT/GEN/15). 
46 For more information, consult:  http://europa.eu.int/comm./enterpr ise/electr_equipment/lv/index.htm , /comm./enterprise/ 
newapproach/legislation/guide/legislation.htm or /comm./enterprise/networks/eic/eic.html.  
47 Director, Technical Regulations, Gove rnment Affairs & Regulations, Telef onaktiebolaget LM Ericsson, Sweden. G/TBT/M/35 
Page 36  
 
Figure 5 
Per Döfnäs WTO TBT Workshop on SDoC  21 March 2005 8Summary: Development of product 
regulation for IT/Telecom within the EU  
E
M
CLV
DTT
EDifferent national 
laws
Pre-1980sE
M
CLV
DTT
E
E
M
CLV
DTT
EAdministrative requirements”Essential reqs” – policy goalsE
M
CL
V
DR
&
T
T
E
2000EU with 
basically same administrative requirements
E
M
CLV
DT
T
E
1980sEuropean Union
Different directives 
with different administrative reqs
?
 
 
105. The Radio Equipment and Telecom Terminal  Equipment Directive from 1999 had aligned 
largely administrative obligations for radio and telecom terminal equipment with the safety/EMC 
directives.  This was especially important for Ericsson due to its product portfolio.  At that point, the 
SDoC regime for most IT and telecom products wa s complete.  Some minor third-party involvement 
remained however, requiring the manufacturers to seek  advice from the "notified body" in the case of 
some "non-harmonized" radio equipment.  Nevertheless,  the European regulatory system in the IT and 
telecom sector functioned well and improved the dynamics of the European market. 
106. Regarding SDoC, the clear benefit from the industry’s perspective was that it explicitly 
placed the responsibility of compliance on the manufacturer.  Hence, somebody empowered by the 
company had to place a signature;  this meant closer  involvement of the management in the approval 
process.  It also ensured compliance without the involvement of a third party.  Cutting costs for 
approval had the effect of speeding up time to mark et and reducing prices of products for consumers. 
107. Moreover, SDoC gave enterprises the possibility  to integrate approvals into the design 
process of a product.  This caused a wider diffusion of knowledge about regulatory compliance within 
the firm.  The harmonized administrative requirement s allowed optimized work organisation, tailored 
to a single set of rules.  External testing la boratories, once only responsible for third-party 
certification, were now often partners on a commerc ial basis and constructively involved in the 
internal design by providing their expertise. 
108. Generally, it was stressed that whether the approach used was SDoC or third party 
certification, it was always possible to cheat if a comp any had that intention.  Therefore, regardless of 
which conformity assessment regime was being u sed, market surveillance was always of major 
importance.  It ensured a level playing field and trust in the system.  In a union of 25 countries, there was a good chance of realizing that objective at a low cost.  Manufacturers expected that market 
surveillance would be done effectively, intelligen tly, and that it would concentrate on compliance 
with the policy objectives of regulation ("technical compliance"). 
109. For companies, it was important that when a ne w regulation came into force, it followed the 
simplest regulatory model already in place for th at given sector, meaning that no administrative 
obligations would be added.  An exemplary regu latory model consisted of objectives, standards,  G/TBT/M/35 
 Page 37 
 
 
conformity assessment procedures as well as information requirements.48  In the global market, it was 
noted that technical requirements still differed acr oss countries.  While with respect to EMC and 
safety, the situation was improving towards the use of international standards, in other areas, such as 
telecom networks, there remained la rge disparities between countries.  It  was a fact that administrative 
requirements sometimes formed de facto  barriers to trade which posed more difficulties to SMEs than 
to large enterprises.  In particular this w as due to overly burdensome conformity assessment 
procedures and varying requirements for the provision of technical information. 
110. In concluding, Mr. Döfnäs stressed that a shift to SDoC without third-party intervention in all 
countries would remove most formal and de facto  trade barriers.  This was demonstrated by the 
positive experience in the EU.  This system assi gned clear responsibilities to the manufacturers and 
relied on international standards.  It necessitated market surveilla nce by the authorities to ensure 
adherence to regulation. 
(b) Discussion 
111. The representative of Argentina  asked if LM Ericsson had conducted studies on the potential 
reductions in consumer prices due  to the introduction of SDoC. 
112. Mr. Döfnäs  replied that he did not have any data on that issue.  This was because of the 
incremental, sector-by-sector character of the shif t from third-party certification to SDoC – over a 
period of 10 to 15 years.  It was difficult to make  estimations.  Mainly, the benefit lay in time saved 
for approval which meant that companies covered co sts of research and development earlier.  For 
economies, the benefits lay in the early  availability of high-tech products. 
113. The representative of Antigua and Barbuda  sought clarification on the duration of the 
transition period Mr Döfnäs had just mentioned (t o SDoC from third party certification).  Was the 
time period of 15 years  particular to the telecom sector, or was it general? 
114. Mr. Döfnäs  clarified that he had been talking abou t the sector of radio and telecom terminal 
equipment.  During the period from 1985 until 2000 the process of EC-wide harmonization and of 
introducing a new regulatory approach – which includ ed the move to SDoC – had taken place.  Other 
sectors that only fell under the LVD and the EMC Directive benefited earlier. 
2. SDoC for Information and Communication Technologies (ICT) Regulations. 
(a) Statement 
115. The representative of Hewlett-Packard , Mr. David Ling49 began by stressing the shared 
objectives between industry and regulators in the information and communications technology sector 
(ICT).  These were: to provide protection, promot e competition, allow growth in a global economy 
and keep regulatory intervention to the necessary minimum.   
116. In particular, two trends needed to be kept in  mind.  The first trend was that both small and 
medium-size enterprises (SMEs) and larger multinati onals might misconstrue the regulatory intent of 
"certification" and how to manage for it.  T hus, regulatory requirements had to clearly place 
responsibility and accountability for safe and legal products on the supplier .  SMEs in the ICT sector 
were often the original design manufacturers, the equipment manufacturers or contract manufacturers 
to larger multinational companies.  They were typi cally located in America, Asia or Central Europe 
and, hence, offered advantages such as lower cost  labour.  When conformity assessment was based on 
                                                      
48 Regarding the emerging legislation on environmental aspects (draft on eco-design, Common Position 9/2005 from the 
European Parliament), Mr. Döfnäs saw some "clouds in the sky".  There were various deviations from the regulatory model of the New 
Approach.  If implemented in th is way, it would be very costly in administrative terms. 
49 Regulatory Policy and Strategy Manage r, Hewlett-Packard, United States. G/TBT/M/35 
Page 38  
 
certification, SMEs might wrongly believe that it wa s the certification body that was responsible for 
ensuring that their products complied with releva nt technical regulations.  In contrast, when 
conformity assessment was based on SDoC, the SMEs clearly understood that it was the supplier who 
was responsible for compliance with the relevant te chnical regulations.  Moreover, when coupled with 
effective surveillance, SDoC rewarded and motivat ed suppliers to improve  programme management 
and make sound engineering judgments.   
117. In addition, certification was not to be e quated with the provision of safe products:  
surveillance was needed under any conformity assessm ent regime, not only under SDoC.  Therefore, 
from an industry perspective, it was important that  regulators highlighted the supplier's accountability 
and responsibility for safe and legal products.  The way to do that was to set requirements for SDoC 
that rendered certification optional and stipulated supp orting documentation.  There was also a need to 
conduct post-market surveillance, and, enforcem ent via penalties would over time reduce the non-
compliance rate across the industry.   
118. The second trend was the prevalence of excessive conformity assessment requirements.  This 
was in violation of Article 5.1.2 of the TBT Agre ement which stipulated that conformity assessment 
procedures could not be stricter than necessary in or der to ensure adequate confidence.  While most 
countries referenced international standards – usua lly from the IEC – in some countries conformity 
assessment involved mandatory, in-country testing by a (third-party) and certification by an 
independent certification body before  the launch of a product (pre-mar ket approval).  Moreover, many 
WTO members did not yet have any regulations in force, and, for those, it was important that they 
introduce international standards and post-market conformity assessment. 
119. The difference between an adequate and an " overbuilt" system was that the latter imposed 
additional requirements (mandatory submission of samples, audits, government-designated test labs, 
obtaining pre-market certificates) which could delay a product's introduction into the marketplace by four to 12 weeks and make intergovernmental MRAs  necessary.  They constituted a burden in terms 
of the delay in revenue which was unrecoverable for the industry.  Consumers also had less choice of 
products and had to pay higher prices.  For a nati ons' economy this had an impact on trade.  When 
conformity assessment was based on pre-market re quirements, fulfilling the obligations under the 
TBT Agreement would mean having to  conclude a bilateral MRA with  every trading partner. That 
was providing an unrealistic salutation; a single MRA was a multi-year effort, and resulted in complexity, lock-in and mistrust.  In contrast, if all trading nations based their conformity assessment 
procedures on SDoC, the doors would automatically be opened to foreign suppliers.  Thus, SDoC 
(based on the international standard ISO/IEC 17050) was the lowest cost model for safe and legal 
products as it did not require any bilateral agreements.   G/TBT/M/35 
 Page 39 
 
 
Figure 6 
April 26, 2005 Worldwide Technical Regulations - Managing Regulations for Global Markets 15
Bilateral Agreement Model - MRA
•Years and years to 
realize … if ever.
•High-cost model
•Complex and redundant
•Mistrust, Lock-in
•Burdens domestic and 
foreign manufacturers
# bilateral agreements n (n-1)/2 
n = # countries with unique 
regulatory systems
 
 
 120. The four types of SDoC recently adopted in the ITA's "Guidelines for EMC/EMI Conformity 
Assessment Procedures" were mentioned.
50  These four types were a good example of what was 
sufficient to provide a workable SDoC framework for many different countries.  For the industry, 
which applauded the ITA Guidelines, either no regulati on at all or one or more of the four SDoC types 
was acceptable.   
121. In concluding, Mr. Ling stressed that know-how  on the implementation of SDoC currently 
existed, and it had been shown to work effectively for IT regulations in many countries.  It improved 
an economy's competitiveness and, hence, there was good reason to move into that direction.  There were several ways of reducing the risk at the beginning of such a transition:  using accredited labs;  
limiting the scope of SDoC to EMI and excluding sa fety;  limiting SDoC to certain product types;  
creating a database of the mature companies allowed to use SDoC;  and, sharing market surveillance 
data, as New Zealand had proposed (paragraph 24 and 28 above). 
(b) Discussion 
122. The representative of Mexico
 stressed that countries could be in compliance with the TBT 
Agreement but still have standards that devi ated from the international ones – moreover, 
harmonization of standards could also  be partial.  Also, it needed to be kept in mind that although 
SDoC made trade easier in some sectors, Mexico had actually experienced import growth in products 
of the IT sector for which pre-market certification was mandatory.  Lastly, he asked about the way in 
which the United States applied SDoC to produc ts – not only in the ICT sector – imported from 
developing countries.  It was evident that for produ cts in which the developed countries had an export 
interest, SDoC was being promoted while this wa s not the case for those of export interest to 
developing countries. 
123. In response Mr. Ling  pointed out that while  it could very well be the case that imports had 
increased without the use of SDoC, the question needed be posed as to  how much better the 
performance might have been with it.  SDoC need ed to be recognized from any country, as long as the 
requirements were fulfilled.  In fact, the US IT indu stry had consistently trie d to persuade the United 
States Government to move towards an SDoC system without any restrictions on the manufacturer's location  for the past 10 to 15 years.  Regarding devel oping countries, it was stressed that there was no 
difference in approach for imports from deve loping countries and developed countries.  The 
                                                     
 
50 Supra  note 35. G/TBT/M/35 
Page 40  
 
confidence in the system lay in the regulators' ab ility to enforce compliance with the regulations 
through market surveillance and penalties.  Mo reover, Asian developing  countries were large 
suppliers in the ICT sector. 
Figure 7 
April 26, 2005 Worldwide Technical Regulations - Managing Regulations for Global Markets 12
Overbuilt CA requirements burden 
suppliers, citizens and economy
•For suppliers :  Delay 4-12 weeks, avg. result in (1) delay in revenue or (2) unrecoverable revenue
•For citizens :  Less choice, higher cost products
•For economy :  Impact trade, hurt e-commerce and e-government objectivesTest & maintain compliance folder
SDoC attestation/Marks/Labels.
Identify accountable party.
Compliance folder available.Design the product to meet int’l 
standard and legal requirements
Obtain pre-mkt certificatesSubmit samples, audits
Use gov’t designated test labShip, based on SDoC
ShipICT Product lifecycle (3-15 months) Obsolete
 
 
124. The representative of Canada , asked whether there had been any cost analysis that could help 
regulators better understand the impact of "overbuilt" conformity on prices.  She referred to the slide 
(Figure 7, above), which showed how such over-bui lt conformity assessment requirement (i.e.  pre-
market, third-party certification) could lengthen the time-to-market by one to three months.  
125. Mr. Ling  noted that in one case a calculation had been made for a country which did not 
recognize foreign tests, hence require d re-testing and demanded to have, inter alia , product samples.  
The result – based on current trade of IT products into that country – had been that due to that specific 
regulation, additional costs for the manufacturer am ounted to US$ 90 million per year on an ongoing 
basis.  Financial burdens to the manufacturers tran slated into disadvantages to the consumers in two 
ways.  First additional costs of conformity assessment  would be distributed among all purchasers of a 
certain product.  Second, costly procedures led ma nufacturers to make an educated guess on which 
products interested clients most in each market.  Thus it frequently happened that a manufacturer 
made only part of his product portfolio available to customers in a foreign market. 
3. Implementing SDoC:  the view of conformity  assessment bodies in developing countries 
(a) Statement 
126. Mr. Rafael Nava51, Mexico , stressed that it was mainly developed countries that owned 
technology and thus markets.  Developing countries were constantly trying to win "a piece of the 
cake" while trying to develop technology as well.   Therefore, developed countries had strong 
industries that had built confidence over the year s and this enabled them to implement SDoC 
procedures.  Industries in developing economies were  generally small or medium sized (SMEs) and 
conformity assessment procedures were usually based  on third party evaluation simply because there 
was not, as yet, enough confidence to move to SDoC  – and, moreover, there existed serious problems 
with such practices as falsificati on, counterfeits or contraband. 
                                                      
51 President of the Commission of Conformity Assessment for the Industrial Confederation of Mexico (Concamin).  G/TBT/M/35 
 Page 41 
 
 
127. For developing countries, hence, the key ques tion was how their manufacturers and suppliers 
could access developed countries' markets despite the f act that most of them did not have a working 
conformity assessment infrastructure (i.e. testi ng laboratories and inspection bodies).  Such an 
infrastructure was needed  to enable them to, inter alia , test their products according to developed 
countries' technical regulations and standards.  Moreover, there needed to be a strong market 
surveillance mechanism c oupled with strong enforcement regula tions in cases of non-compliance.  
For low risk products, legislation needed to provid e for SDoC that was based on testing reports of 
accredited testing laboratories as an alternative  to third party certification.  When there were well-
performing testing laboratories in developing countries , it would be easier to work with the developed 
trading partners and build trust.   
128. Mr. Nava pointed out that if SDoC was impl emented without meeting the above-specified 
conditions, there was a risk of the spread of info rmal commerce practices which could lead to unfair 
competition.  Also, developing countries might rece ive products which had been rejected in other 
economies or products that – though meeting the re quirements of other countries – were not suitable 
for a developing country operating environment (for in stance, with respect to  the use of electrical 
equipment in countries with highly varying electrical power supply). 
129. The ways in which developed countries could facilitate a successful implementation of SDoC 
in developing countries included:  (i) fostering the establishment of conformity assessment infrastructure in developing countries while recognizing the needed for time and resources;  (ii) engaging in information exchange and the acc eptance of testing reports by means of MRAs;  
(iii) helping developing countries to participate in  drawing up international standards; and, by 
assisting developing countries to develop and implem ent local technical regulations and evaluation 
schemes.   
(b) Discussion 
130. The representative of Argentina
 noted that it was important to consider the cases where SDoC 
had been applied to products of export interest  to developing countries.  While some developed 
countries were willing to accept declarations of conf ormity from developing countries, if there was no 
appropriate infrastructure in developing countries, c onfidence could not be maintained in the long run. 
131. Mr Ling  noted that in the case of the IT industry, the bulk of manufacturing was actually done 
in developing countries such as Chinese Taipei and China and subsequently exported and accepted 
through SDoC procedures.  Regarding the need for time, he stressed that the concept of SDoC had 
been refined over a long period of time and proven to  work well in multiple countries.  Therefore, 
developing countries could simply adopt it as it was,  without having to go through the same steps of 
different conformity assessment methods which had taken developed countries decades to get though. 
132. The representative from Antigua and Barbuda  stressed that the issue was not time, but rather 
one of resources.  In other words, technical as sistance that merely helped understand ISO/IEC 17050 
better was not sufficient.  What was actually need ed were resources to implement the appropriate 
infrastructure at the national level. 
133. The representative of th e European Communities  pointed out that it was necessary not to 
forget the benefits of SDoC for a country's own national economy.  The LVD in Europe was of great 
benefit primarily domestically:  it was no so much a bout helping exports.  In fact, exporters were in 
any case often faced with third-party certification in  their export markets.  The real boost to an 
economy arising from the use of SDoC came from f aster access to more modern technology and 
cheaper prices for consumers.  
134. The representative of the United States  re-emphasized that there was no obligation 
whatsoever to impose SDoC in any country:  it was merely an option.  It was less bureaucratic and G/TBT/M/35 
Page 42  
 
less intrusive than some other approaches to conf ormity assessment, and it required less infrastructure. 
Whatever approach was used, eff ective enforcement would go a long way to enhance a domestic 
manufacturer's ability to compete in the global marketplace. 
C. C
ONCLUSION  
135. The Chairman  recalled that, at the Third Triennial Re view of the TBT Agreement, concluded 
in November 2003, the Committee had agreed to a Work Programme on conformity assessment to 
improve Members' implementation of Articles 5-9 of the TBT Agreement and, in particular, to 
promote a better understanding of conformity assessmen t systems (G/TBT/13, paragraph 40).   Hence, 
in response to the recommendation contained in G/TBT/13 (paragraph 40, second tiret) the 
Committee had held a Workshop on this subject. This  had, essentially, been a "learning event" where 
delegations exchanged informa tion and experiences on the SDoC, which, he recalled, was one 
element of the Committee's broader work programme on conformity assessment.  
136. In terms of the structure of the workshop, pa rticipants had heard two general presentations:  
the WTO Secretariat had given an overview of the ke y issues raised in relation to SDoC based on the 
submissions and statements made in the TBT Co mmittee to date (JOB(05)/30).   Second, the 
representative of the ISO had described the new ISO/IEC Standard on Supplier's Declaration of 
Conformity (ISO/IEC 17050).  Subsequently, there had been six presentations on the "Government's 
Perspective" and three presentations on the "Manufact urer's or Supplier's Perspective" (industry), 
followed by a discussion. 
137. It was emphasized that SDoC was one option  among various approaches available to 
facilitate the acceptance of conformity assessment results  (other approaches remain  an option).  In this 
regard, it remained the prerogative of governments to choose the type of regulatory regime to put in 
place to ensure (and achieve confidence) that produ cts conformed to requirements and met legitimate 
policy objectives (such as the protection of human health or safety). 
138. In making a decision as to whether to use SDoC or not, several factors  could come to bear.  
One factor frequently mentioned at the Workshop was the level of risk involved in the area of 
application.  While some speakers noted that SDoC was primarily used for products with low risk to 
the consumer or the environment (Chinese Taipei, Brazil and Mexico), others made the point that 
SDoC could also be adapted to risk (Canada) and be used in relatively high -risk areas (vehicle safety 
standards in Korea and electrical products in the EC).   
139. For industry, SDoC could be cost effective  in that, for instance, third party certification costs 
were avoided.  This saved valuab le time.  SDoC could also facilitate the portability of results and 
avoid what one speaker had referred to as "over-built"  conformity assessment requirements.  In light 
of this, it was not surprising that industry was th e main driver behind the development of the IEC/ISO 
Standard on SDoC.  The point had been made by a number of speakers that in those countries (and 
sectors) where industry used SDoC there were poten tial benefits to consumers in terms of greater 
choice of products and lower prices.   
140. However, there were potential regulatory costs  as well – and these could be particularly 
burdensome for developing countries.  It appeared that there was a need for each Member to find a 
balance between the benefits of using SDoC and the administrative or regulatory costs that were 
incurred in setting up the needed infrastructure.   For example, in terms of infrastructure, several 
participants and speakers emphasized the need to establish a functioning market surveillance 
mechanism which would enable regulators to deal with non-compliance (enforcement).  Participants 
had heard how this was done in the automobile sect or in Korea, and with electrical products in the 
EU.  G/TBT/M/35 
 Page 43 
 
 
141. Moreover, a number of developing countries  had stressed their need for technical assistance 
and resources both in order to participate more eff ectively in the international standard-setting process 
but also – and perhaps key – to be able to impl ement the use of SDoC (based on the international 
standard).  In most cases, the industries in deve loping countries were small and medium-sized (SMEs) 
and it was felt by some that these countries had not, as yet, built enough confidence to make the 
transition (where it was desirable) to the use of SD oC. It was noted that the transition to SDoC, in 
certain sectors, from third party certification had take n many years (in the EU 10-15 years).  Yet, for 
developing countries time was pressing:  it was impor tant to establish the appropriate conformity 
assessment infrastructure that would help establis h confidence in markets for products of export 
interest also to their economies.   
142. Finally, the Chairman stressed that discussions  had been substantive and that, overall, the 
workshop had lent some more clarity to a complex and technical area of conformity assessment.   
143. The representative of Mexico  stressed that it was not possible to draw the conclusion that 
SDoC was better than certification.  Although SDoC  was certainly a useful tool, the usefulness of 
either procedure depended heavily on the policy ai ms, and each country's individual requirements.  
Finally, no Member opposed the use of SDoC as an approach to conformity assessment.  The 
concerns were about obstacles to implementation.  Much remained to be done regarding 
infrastructure, technical assistance, c onfidence-building as well as risk-taking.  
144. Mr. Ling  wished to clarify the difference between third party certification and SDoC.  He 
emphasized that the former required manufactur ers to submit documentation from a third party 
(confirming conformity) and the latter allowed the manufacturers to do that themselves.  Testing 
needed to be viewed separately.  It could be done  by the manufacturer, an independent laboratory or 
an accredited laboratory.  Hence, depending on the re gulations, testing for SDoC could indeed involve 
a third party.   
145. The representative of Grenada  urged Members to consider the particular case of the 
Caribbean countries and stressed that the Caribbean did not have separate regulatory entities to deal 
with TBT and SPS related issues. G/TBT/M/35 
Page 44  
 
ANNEX 2:  ON-LINE COMPLETION OF TBT NOTIFICATIONS
52 
 
 At the Third Triennial Review the Committee ag reed to examine the feasibility of creating a 
central depository for notifications on the WTO we bsite.  This would complement, not replace, the 
submission of notifications to the CRN (paragraph 27 of G/TBT/13 (first tiret)).  At the November 
2004 meeting, the representative of Canada drew the Committee's attention to this recommendation 
which had been based on a Canadian proposal and requ ested the Secretariat to look into the feasibility 
of setting up such a facility.  This note h as been prepared in r esponse to this request. 
  The Committee may wish to note that, on the initiative of the Agriculture and Commodities 
Division, relevant work has commenced on an SPS information management system which is aimed, 
inter alia , at facilitating the Secretariat's tasks in the management of notifications.  Examples of the 
types of tasks that the information management syst em will help the Secretariat deal with, include, the 
preparation of annual reports (summary statistics) , and its responses to queries about notifications 
from delegations.  Another key objective of this pr oject is to improve coherence among Divisions of 
the WTO Secretariat which are involved in the mana gement of notifications (operational Divisions, 
CRN, Documents-On-Line, etc.).  As a first step, the WTO's IT team will establish this information 
management system for the Secretariat's own intern al use ("Phase I" of the project).  A second phase 
would entail providing Members query access thr ough the WTO website.  The funding for the 
creation of the software application to support the SPS information management system has been 
secured by the Agriculture and Commodities Division. 
 
 Since the last meeting of the TBT Committ ee, the Trade and Environment Division has 
discussed the subject with the IT team who have ag reed to ensure that the software application 
developed is also adaptable to TBT notifications, or  will be flexible enough also to include the entry 
of TBT notifications.  However, for the developmen t and entry of data for the TBT side of this 
information management system, additional resour ces would be needed (over 6100 notifications have 
been made since the entry into fo rce of the Agreement).  For this purpose, the Trade and Environment 
Division will seek funding for the TBT side of this  project during this year's budget exercise. 
  Canada's proposal is about an on-line notification facility.
53   This is not, as yet, envisaged in 
the project that the IT team is working on.  Once the information management system is set up, and 
subject to availability of funding and appropriate IT security measures, the possibility of developing 
such an application will be looked in to.    
                                                      
52 At the time of the meeting, this information was provided in JOB(05)/33. 
53 The representative of Canada stated at the November meeting th at: "The idea was to offer Member s an alternative to the way in 
which they currently submitted notifications , by creating an electronic notification fo rm which could be added on to the WTO we bsite, filled 
in on-line and automatically sent to the CRN.  The notification wo uld be received by the Secretaria t, scanned to ensure its com pleteness and 
accuracy and then forwarded through the usua l channels.  While recognizing that not a ll Members might be in a position to take advantage 
of an e-form, this was an attempt to maximi ze the amount of time to make comments on  other Members' notifications." (G/TBT/M/34 , 
paragraph 120).  G/TBT/M/35 
 Page 45 
 
 
 
ANNEX 3: WORK PROGRAMME FOR THE FOURTH TRIENNIAL REVIEW 
 
1. Article 15.4 of the Agreement on Technical Barriers to Trade (TBT Agreement) provides 
that:  "Not later than the end of the third year fro m the date of entry into force of the WTO Agreement 
and at the end of each three-year period thereaf ter, the Committee shall review the operation and 
implementation of this Agreement, including the prov isions relating to transparency, with a view to 
recommending an adjustment of the rights and obli gations of the Agreement where necessary to 
ensure mutual economic advantage and balance of rights and obligations, without prejudice to the 
provisions of Article 12.  Having regard, inter alia,  to the experience gained in the implementation of 
the Agreement, the Committee shall, where appropria te, submit proposals for amendments to the text 
of this Agreement to the Council for Trade in Goods". 
2. The Committee concluded the First, Second and Third Triennial Reviews of the Operation 
and Implementation of the TBT Agreement on 13 November 1997 (G/TBT/5), 10 November 2000 
(G/TBT/9) and 7 November 2003 (G/TBT/13), respectiv ely.  In light of the mandate quoted above, 
the aim is to conclude the Fourth Triennial Re view at the Committee's last meeting in 2006. 
3. Article 15.4 states that the Committee shall at the end of each three-year period undertake the 
review work.  In order to prepare for this review work and to ensure efficiency, the work programme 
(overleaf) sets out three stages:  identification, discussion and drafting.  In essence, this approach 
means that, by mid-cycle (June 2005), the Committee would shift its focus from the follow-up of the 
Third Triennial Review to the preparation of the Fourth.   
4. Three formal meetings of the TBT Committee have been scheduled for 2005 and another 
three are foreseen to be held in 2006.   
5. It is proposed that the review work be initiate d at the First meeting in 2005 with a preliminary 
identification of topics for review.  It is stressed that this list will be preliminary and that Members 
would be able to add to or modify it during th e discussion phase of the review work.  At its Second 
and Third meetings in 2005, it is proposed that the Committee hold focused discussions on topics that 
have been identified.  Members will be encourag ed to submit papers on the issues identified for 
consideration.  To facilitate the discussion, the Secretariat will prepare factual background notes on 
specific topics under discussion.   
6. At its First meeting in 2006, the Committee s hould be in a position to take stock of the 
discussions.  To assist the Committee in this stockt aking exercise, the Secretariat will prepare a  
summary of the key issues discussed, under each topic iden tified.  This draft will be factual in nature 
and will not contain any recommendations.  
7. The Second meeting in 2006 will mark the start of the drafting phase.  For that meeting, the 
Committee will have before it a first draft of the Fourth Triennial Review, including both the factual 
elements and any recommendations on which there is general agreement.   
8. In respect of the conduct of the review work it self, it is proposed that substantive discussions 
pertaining to the review will normally be held in formal mode under an agenda item dedicated to the 
review process (currently Agenda Item 3 "Triennial  Review").  After circulation and discussion of the 
first draft of the Fourth Triennial Review, incl uding both the factual part and any recommendations on 
which there is general agreement, necessary drafting will take place in open-e nded informal meetings.  
These meetings will, to the extent possible, be held  back-to-back with the regular meetings of the 
Committee.  The Chairman will subsequently re port on the results in the formal meeting. G/TBT/M/35 
Page 46  
 
9. The Committee to adopt the final text of the Fourth Triennial Review at its Third meeting in 
2006. 
10. The work programme should be seen as flexible  and may be modified in light of any new 
developments.   
Work Programme for the Fourth Triennial Review
 
 
Dates / Time Frame Proposed Action 
Identification phase  
mid-February 2005 Preliminary identificati on of topics for review by delegations 
First meeting in 2005 Listing of topics and organization of discussion 
 
Discussion phase  
end-April 2005 Circulation of S ecretariat note on topics to be discussed at the next 
meeting 
mid-May 2005 Submissions by dele gations on topics to be di scussed at the next meeting 
Second meeting in 2005 Discussion on topics identified 
mid-September 2005 Circulation of  Secretariat note on topics to  be discussed at the next 
meeting 
mid-October 2005 Submissions by de legations on topics to be di scussed at the next meeting  
Third meeting in 2005 Discussion on topics identified 
end-January 2006 Submission by delegati ons of proposals for recommendations  
end-February 2006 Circulation by the Secretariat of draft of factual elements of the review  
First meeting in 2006  Stocktaking:   
Discussion of draft of factual elements of the review as well as any 
proposed recommendations. 
 
Drafting phase  
mid-June 2006 Circulation of first draft text of the Fourth Triennial Review, including 
both the factual part and any recomme ndations on which there is general 
agreement 
Second meeting in 2006 Discussion of draft text of the Fourth Triennial Review 
mid-September 2006 Circulation of the draft fi nal text of the Four th Triennial Review 
Third meeting in 2006 Adoption of the final text of the Fourth Triennial Review 
 
 
 
__________