WORLD TRADE  
ORGANIZATION  G/TBT/W/268 
12 June 2006 
 
 (06-2789) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
FOURTH TRIENNIAL REVIEW OF THE AGREEMENT ON 
TECHNICAL BARRIERS TO TRADE 
 
GOOD REGULATORY PRACTICE AND TRANSPARENCY 
 
Communication from Chile
 
  
I. INTRODUCTION 
1. The paper JOB(06)/142 gives a factual summary of the issues raised by delegations during the 
preparation of the Fourth Triennial Review of th e Agreement as well as a brief summary of relevant 
developments under previous reviews, and makes so me proposals for each element considered in the 
Reviews.  It also invites delegations to comment on the document or make drafting proposals to facilitate discussion at the June meeting. 
2. On the basis of that document Chile wishes to enlarge on some of the ideas proposed in 
connection with regulatory practice and transp arency and to submit a draft for discussion. 
II. GOOD REGULATORY PRACTICE 
3. Ever since the First Triennial Review of the Agreement, the Committee has been pointing out 
that in order to facilitate trade Members should as a matter of priority adopt good regulatory practice 
in preparing, adopting and applying technical regulations and conform ity assessment procedures. 
4. The Committee has also noted that good regul atory practice can contribute to effective 
implementation of the TBT Agreement, particular ly in the avoidance of unnecessary obstacles to 
trade. 
5. The Committee has furthermore recognized that  for a Member to achieve good regulatory 
practice and to comply with the Agreement at the domestic level, it may be necessary both to develop 
domestic policies or regulatory processes, and to establish administrative mechanisms to ensure that all relevant bodies are aware of and understand th eir obligations under the Agreement and know how 
to comply with them.  In addition, domestic coordination and cooperation, including with local 
governments, as well as with non-gove rnmental parties, is important. 
6. Members have been invited to exchange experiences inter alia  in identifying elements of 
good regulatory practice at the domestic level. 
7. Chile's experience, which we have shared with other Members on a number of occasions, 
consists of the creation in 1997 of a National Committee on Technical Barriers to Trade, which 
coordinates at national level the TBT-related act ivities of the various regulatory bodies.  Our 
experience has shown that even when  not backed up by a law, decree or some other legal instrument, 
these coordination activities are worthwhile inter alia  because of the good will shown by the G/TBT/W/268 
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  institutions, which feel that they are involved and pl aying a part.  Thanks to the national committee, it 
is possible to fulfil our obligations under the Agreem ent to the ultimate benefit of society as a whole. 
8. Although Members are free to decide how they will meet their obligations under the 
Agreement, successful experiences can be useful  as good examples to follow.  Chile therefore 
proposes that as an outcome to the Fourth Tr iennial Review, the Committee should agree: 
• "To recommend that Members set up nati onal TBT coordinating committees;   
 
• that these committees be assigned specific task s the results of which have the support 
of all the committee members, so that if they are taken on board as the institutions' 
own achievements their subsequent adop tion and implementation will be easier." 
 9. In Chile's view, good regulation is important.  Suitable and coherent regulatory instruments 
that encourage and maintain a competitive envi ronment make a major contribution to trade 
facilitation.  A regulatory agenda that is efficient and clearly understood will facilitate trade as well as 
attracting sound investment. 
10. In 2004, Chile's National Committee issued D ecree No. 77 setting forth requirements for the 
preparation, adoption and application of technical regulations and conformity assessment procedures.  
It is attached hereto in Spanish and in English for Members' information. 
11. We propose in this connection that in order to provide a solid basis for the coordination 
bodies that Members will be establishing, the Committee should agree: 
• "To recommend to Members that one of the tasks to be performed by the national 
TBT committee to be set up by each Member should be to produce some legal instrument setting forth criteria for the fo rmulation of technical regulations or 
conformity assessment procedures.  Such an instrument should be the outcome of 
work undertaken jointly by all the instituti ons, so that it draws its validity more from 
its basis in consensus than from the b asis in law it affords for the criteria." 
 
III. TRANSPARENCY 
12. Transparency is a key element of good regulatory practice.  However, it is of such relevance 
that it stands out as an issue on its own and is trea ted as such in many of the proposals put to the 
Committee.  One such proposal concerns facilities for accessing information about measures that have 
been notified to the WTO. 
13. In our experience, notification to the WTO of a draft technical regulation or conformity 
assessment procedure immediately prompts at least five requests from Members seeking the texts of 
the draft.  This means that the notifying Member ha s to dispatch the text at least five times by e-mail 
or fax. 
14. In order to make this transp arency measure more efficient,  we propose that the Committee 
should agree: 
• "To recommend to Members that on notifying to the WTO a draft technical regulation 
or conformity assessment procedure, it should state "Texts available at", giving the Internet address at which the text can be downloaded, or should attach the file 
containing the relevant text directly to the notification." 
  G/TBT/W/268 
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  15. Again in the interests of transparency, Members should have access to the replies to the most 
significant comments prompted by a notification.  Th is would not only enable the Members concerned 
to find out how their comments were taken into  account, but would allow all Members to gain 
experience of issues that raise concerns about TBT matters and of how they are resolved.  For our 
part, we have included such a transparency measure in Decree No. 77, referred to earlier. 
16. Chile therefore proposes that the Committee should agree: 
• "To recommend to Members that once the notified regulation or conformity 
assessment procedure has been published, the replies to the most significant 
comments received should be made available to interested parties through either a 
notification to the WTO or an Internet address or by some other means." 
 
 G/TBT/W/268 
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  ANNEX 
 
IMPLEMENTING REGULATIONS TO  TITLE 1 OF LAW NO. 19.912 AND 
REQUIREMENTS FOR THE PREPARATION, ADOPTION AND 
APPLICATION OF TECHNICAL REGULATIONS AND 
CONFORMITY ASSESSMENT PROCEDURES 
 
 
Santiago, 24 February 2004 No. 77 (O.J. 14 June 2004) 
 
CONSIDERING:  Article 32(8) of the Political Constitution of th e Republic of Chile;  the Agreement on Technical 
Barriers to Trade of the World Trade Organization which forms part of the results of the Uruguay 
Round of multilateral trade negotiations, which were ratified by the Chilean Congress and 
promulgated by Supreme Decree No. 16 of 1995 of the Ministry of Foreign Affairs;  and Article 5 of 
Law No. 19.912 aligning the legislation indicated th erein with the Agreements of the World Trade 
Organization to which Chile is a party.  WHEREAS: 
 
 The Ministry of the Economy, Development and Reconstruction is the administrator in Chile 
of the Agreement on Technical Barriers to Trade of  the World Trade Organization ("TBT Agreement" 
in Annex 1A of the WTO Agreement) herein afte r "TBT Agreement", and the contact point for the 
relevant bilateral or regional agreements; 
 
 It is necessary to ensure fulfilment of the ob ligations deriving from the said Agreement and 
related bilateral or regional agreements, as concer ns the preparation, adoption and application of 
technical regulations and the corres ponding conformity assessment procedures; 
  It is necessary to establish criteria for the prep aration, adoption and application of technical 
regulations and related conformity assessment pr ocedures to ensure that these do not constitute 
unnecessary technical barriers to trade.   
DECREE 
 
SCOPE 
 
 Article 1 .  This regulation shall apply to the pr eparation, adoption and application of 
technical regulations and conformity assessment  procedures in a manner consistent with the 
provisions of the TBT Agreement. 
 
 The term "adoption" refers to the completion of the legal processing of technical regulations and/or conformity assessment procedures and th eir publication in the Official Journal. 
  The term "application" refers to the mo ment from which compliance with a technical 
regulation or conformity assessment procedure is enforceable. 
  Where laws lay down special procedures, this  decree shall apply on a supplementary basis. 
  For the purposes of this decree the following definitions shall apply:  G/TBT/W/268 
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 Technical regulation :  a provision whereby the competent authority, through an 
administrative act, lays down product characteris tics or their related processes and production 
methods, including the applicable administrative prov isions, with which compliance is mandatory.  It 
may also include or deal exclusively with termi nology, symbols, packaging, marking or labelling 
requirements as they apply to a product, process or production method.  Its preparation, adoption and 
application shall be the responsibility of the mini stries or other bodies having competence therefor. 
  Conformity assessment procedure :  any procedure used directly or indirectly to determine 
compliance with the relevant requirements of technical regulations.  Conformity assessment 
procedures include procedures for sampling, testing and inspection;  evaluation, verification and 
assurance of conformity;  registration, accreditati on and approval, as well as their combinations. 
 
PRINCIPLES 
 
 Article 2 .  Where technical regulations and/or c onformity assessment procedures are required 
and relevant international standa rds exist or their completion is imminent, ministries or bodies 
empowered to adopt them shall use such internationa l standards or the releva nt parts of them as a 
basis for their regulations or procedures, except wher e these institutions consider that they would be 
an ineffective or inappropriate m eans for the fulfilment of the legitimate objectives pursued.  National 
standards that have adopted international standards shall be deemed to meet the requirements of this 
Article. 
  Article 3 .  Technical regulations and/or conform ity assessment procedures shall not be more 
trade-restrictive than is necessary to fulfil a le gitimate objective, taking account of the risk non-
fulfilment would create.  Such legitimate objectives are, inter alia , national security requirements, 
protection of human health or safety, animal or plant life or health, or the environment, or the 
prevention of misleading practices.  In accessing such risk, relevant elements for consideration are, 
inter alia , available scientific and technical informati on, related processing technology or intended 
end-uses of products.   Article 4 .  Technical regulations shall be prepared , adopted or applied in such a way that 
imported products are accorded treatment no less fa vourable than that accorded to like products of 
national origin and to like products originating in another country.  Furthermore, conformity 
assessment procedures shall be so prepared, adopted  and applied as to provide access for suppliers of 
like products originating in any other country under conditions no less favourable than those accorded 
to suppliers of like products of national origin or originating in any other country, in a comparable 
situation. 
  Article 5 .  Wherever appropriate, technical regulati ons based on product requirements shall 
be specified in terms of performance rather than design or descriptive characteristics. 
 
PROCEDURES 
 
 Article 6 .  The preparation, adoption and appli cation of technical regulations and/or 
conformity assessment procedures and any amendmen t thereto shall be subject to the following 
provisions:  
 (a) Without prejudice to Article 7, the ministry or body empowered to regulate shall 
publish, in the form of a notice published in  the national media or on its web site, the 
draft of the technical regula tion or conformity assessment pr ocedure that it intends to 
adopt. 
 G/TBT/W/268 
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   (b) The above-mentioned notice shall include at  least an extract from the draft technical 
regulation or conformity assessment procedure and shall state where the text can be consulted in full.  The extract shall state the purpose of the draft and the reasons for 
the approach adopted.  At the same time, a copy of the extract and the draft regulation 
shall be sent to the Ministry of the Ec onomy, Development a nd Reconstruction for 
the purposes established in Article 9. 
  (c) As from the date of publication of the no tice referred to in (a) above, the competent 
authority shall make available to interested  parties a report which shall contain a brief 
explanation of the purpose and content of the planned measure;  the alternatives 
considered and the reasons for rejecting them;  a description of the advantages and 
disadvantages and of the technical feasib ility of verifying implementation of the 
measure;  and the existence of applicab le international standards on the subject. 
  (d) The notice referred to in (a) above shall be published long enough in advance of the 
adoption of the measure to enable anyone so wishing to submit comments in writing 
accompanied by any relevant documentation during a period of at least 60 days. 
  The ministry or body empowered to regulate shall analyse the comments and shall take them into account.  It shall make available to the public any replies received to significant comments, at the 
same time as publishing the final technical re gulation or conformity assessment procedure. 
 
 Notwithstanding the previous paragraph, no one  shall require the competent authority to 
supply confidential information the dissemination of which may be an obstacle to compliance with the 
law or run contrary to the public interest in any ot her manner, or harm the legitimate trade interests of 
public or private companies. 
 
 (e) The technical regulations and/or c onformity assessment procedures shall make 
provision for a reasonable period between the da te of their adoption and that of their 
implementation.  "Reasonable period" shall mean a period of not less than six months except where this would hinder attainment of legitimate objectives.   
 
 Article 7 .  In the event of duly substantiated urge nt safety, health, environmental protection 
or national security problems or a threat of such problems, the ministry or body empowered to regulate may bypass the formalities provided for in  the previous article and shall notify the 
regulation's entry into force to the Ministry of  the Economy, Development and Reconstruction. 
 
 Article 8 .  Notwithstanding the previous article, upon adoption of the technical regulations 
and/or conformity assessment procedures in the cas es referred to therein, the competent authorities 
shall afford ample opportunity for anyone so wi shing to submit written comments accompanied by 
any necessary documentation.   The ministry or body empowered to regulat e shall analyse the comments received and shall 
take them into account.  It shall also make availa ble to the public any replies received to significant 
comments.   Article 9 .  The Ministry of the Economy, Developm ent and Reconstruction shall comply with 
the relevant formalities for notifyi ng draft regulations and/or c onformity assessment procedures and 
for receiving comments from the other Members of th e World Trade Organization, in accordance with 
Article 2.9;  Article 3.2 and 3.3;  Article 5.6;  and Article 7.2 and 7.3 of the TBT Agreement, as 
appropriate.   G/TBT/W/268 
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   Except in the cases set forth in Article 7 a bove, technical regulations and/or conformity 
assessment procedures notified to the World Trad e Organization pursuant to the above-mentioned 
provisions, may be issued by the entities empowered therefor only after a period of at least sixty days following their notification to the WTO by the Ministry of the Economy, Development and Reconstruction, the State Secretariat c oncerned being informed in due course. 
 
 In the cases referred to in Article 7, the Ministry of the Economy, Development and Reconstruction shall complete the re levant formalities for notifying th e regulations and/or conformity 
assessment procedures and for receiving comments, in  accordance with Article 2.10;  Article 3.2 and 
3.3;  Article 5.7;  and Article 7.2 and 7.3 of the TBT Agreement, as appropriate. 
 
 Article 10.   The technical regulations and/or conf ormity assessment procedures must include 
the following information, as appropriate:   Identification of the product, including its classification in the Harmonized Commodity 
Description and Coding System (HS) and the purpose of the measure; 
  The specifications and characteristics of the product, method or process established in the 
regulation in accordance with its purpose;   Conformity assessment methods; 
 
 The data and other information to be displayed on the products or else on their containers and 
packaging and their marking requirements, and the si ze and characteristics of the various indications, 
if appropriate;  
 The extent of their consistency with interna tional standards and guidelines used as a basis in 
their formulation;   Mention of the institution or institutions res ponsible for enforcing the regulations.  This 
requirement shall be deemed to have been met wher e the technical regulation refers to some provision 
of the law that identifies the supervisory institution. 
 
 Any other information considered necessar y for a proper understanding of the regulation 
including its scope.   Any of the above-mentioned elements shall be deemed to have been included if they are 
contained in one or more standa rds referred to in the technical regulation or conformity assessment 
procedure.   Article 11.  Any technical regulations and/or conf ormity assessment procedures that are 
adopted shall be supported by the following documenta ry support, which shall be made available to 
anyone requesting it: 
 
 The technical grounds for the authority's deci sion, showing the policy objectives pursued and 
giving a description of how the technical re gulation will contribute to attaining them; 
  A description of the options analysed by th e competent authority and their advantages and 
disadvantages, including information about the most relevant international pr actices and giving the 
reasons on which the decision was based;  G/TBT/W/268 
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   An account of the process for receiving comments, including a description of its various 
stages starting with the public notice that launched th e process, and a list of the institutions that took 
part in formulating the technical regulation;   A description of the amendments made to the original proposal as a result of the comments 
process; 
  A description, at least in qualitative terms, of  the possible impact on the domestic market, the 
costs of implementation and the costs of supervision;  
 A description, at least in qualitative terms,  of the impact on small and medium-sized 
enterprises, as appropriate;  and   Any replies to the comments received within  the period for submission of comments, in 
accordance with Article 6(d) and Article 8 of this decree. 
 
TO BE RECORDED, REGISTERED AND PUBLISHED IN THE OFFICIAL JOURNAL  RICARDO LAGOS ESCOBAR   JORGE RODRIGUEZ GROSSI PRESIDENT OF THE REPUBLIC   MINISTER OF THE ECONOMY AND ENERGY  
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