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ORGANIZATION OF AMERICAN STATES - TRADE UNIT

PROVISIONS ON STANDARDS AND CONFORMITY ASSESSMENT IN TRADE AND INTEGRATION ARRANGEMENTS OF THE WESTERN HEMISPHERE

SG/TU/WG.STBT/DOC.6/96/Rev.3
9 February 1998
Original: English
Limited Distribution


Part I

PROVISIONS ON STANDARDS AND TECHNICAL BARRIERS TO TRADE
IN SUBREGIONAL TRADE AND INTEGRATION ARRANGEMENTS


I. DEFINITIONS

A. Standard

WTO Annex I: Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method.
NAFTA Article 915: A document, approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for goods or related processes and production methods, or for services or related operating methods, with which compliance is not mandatory, It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a good, process, or production or operating method.
Andean Community

Annex II: A document, established by consent and approved by a recognized body, that provides for common and repeated use, rules, directives or characteristics of activities or their results, with the end of guaranteeing an optimum order within the given context.

Note: Standards should be based on the consolidated results of science, technology and experience in order to obtain optimum benefits for the community. Standards are of voluntary application. (Decision 376)

CACM  
Group of Three Article 14-01: A document approved by a recognized standardization body that provides, for a common and repeated use, rules, guidelines or characteristics for goods or related processes and production methods, whose observance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a good, service, process or related production method.
MERCOSUR Resolution GMC No 152/96: Item 3.2

ALADI 1

Article 22.- For the purposes of the present Agreement, the definitions established in the World Trade Organization on Technical Barriers to Trade shall apply.

CARICOM 2  

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B. Technical Regulation

WTO Annex I: Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method.
NAFTA Article 915: A document which lays down goods characteristics or their related processes and production methods, or services characteristics or their related operating methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a good, process, or production or operating method.
Andean Community

Annex II: A regulation that contains technical requirements or makes reference to standards or technical specifications or codes of practice or integrates them into its content. (Decision 376)

(Regulation: A document that contains rules of obligatory character and is approved by a competent authority.)

CACM  
Group of Three Article 14-01: A document which establishes characteristics of goods or their related processes and production methods, or characteristics of services or their related operating methods, including applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements of a good, service, process or related production method.
MERCOSUR Resolution GMC No. 152/96: Item 3.3.

ALADI

See Article 22. (Supra)
CARICOM  

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C. Conformity Assessment Procedures

WTO Annex I: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.
NAFTA

Article 915: Any procedure used, directly or indirectly, to determine that a technical regulation or standard is fulfilled, including sampling, testing, inspection, evaluation, verification, monitoring, auditing, assurance of conformity, accreditation, registration or approval used for such a purpose, but does not mean an approval procedure.

(Approval Procedure: Any registration, notification or other mandatory administrative procedure for granting permission for a good or service to be produced, marketed or used for a stated purpose or under stated conditions.)

Andean Community

Annex II: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.

Note: Conformity assessment procedures comprise, among others, those of sampling, testing and inspection; evaluation, verification and assurance of conformity, registration, accreditation and approval, in separate form or in distinct combinations. (Decision 376)

CACM  
Group of Three Article 14-01: Any procedure utilized, directly or indirectly, to determine that the relevant requirements established by standards or technical regulations have been fulfilled, including sampling, testing, inspection, evaluation, verification, assurance of conformity, accreditation, certification, registration or approval, used for those purposes, but does not mean an approval procedure. (Approval Procedure: A registration, notification, or any other mandatory administrative process for obtaining a permit so that a good or service may be marketed used for stated purposes under established conditions.)
MERCOSUR  

ALADI

See Article 22 (supra).
CARICOM  

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D. Standards-Related Measure

WTO  
NAFTA Article 915: A standard, technical regulation or conformity assessment procedure.
Andean Community  
CACM  
Group of Three Article 14-01: Standards, technical regulations or conformity assessment procedures.
MERCOSUR  

ALADI

See Article 22.
CARICOM  

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I. POLICY OBJECTIVES

A. Standards

WTO Article 4.1: Members shall ensure that their central government standardizing bodies accept and comply with the Code of Good Practice for the Preparation, Adoption and Application of Standards in Annex 3 to this Agreement. They shall take such reasonable measures as may be available to them to ensure that local government and non-governmental standardizing bodies of which they or one or more bodies within their territories are members, accept and comply with this Code of Good Practice. In addition, Members shall not take measures which have the effect of , directly or indirectly, requiring or encouraging such standardizing bodies to act in a manner inconsistent with the Code of Good Practice. The obligations of Members with respect to compliance of standardizing bodies with the provisions of the Code of Good Practice shall apply irrespective of whether or not a standardizing body has accepted the Code of Good Practice.

Article 4.2: Standardizing bodies that have accepted and are complying with the Code of Good Practice shall be acknowledged by the Members as complying with the principles of this Agreement.

NAFTA Article 906.2: Without reducing the level of safety or of protection of human, animal or plant life or health, the environment or consumers, without prejudice to the rights of any Party under this Chapter, and taking into account international standardization activities, the Parties shall, to the greatest extent practicable, make compatible their respective standards-related measures, so as to facilitate trade in a good or service between the Parties.

Article 906.3: Further to Articles 902 and 905, a Party shall, on request of another Party, seek, through appropriate measures, to promote the compatibility of a specific standard or conformity assessment procedure that is maintained in its territory with the standards or conformity assessment procedures maintained in the territory of the other Party.

Andean Community Article 10: The Member Countries shall harmonize, in gradual form, existing national standards in each country or shall adopt those that they consider to be of subregional interest. The result of this process shall give place to Andean standards that shall be communicated by the Committee to the Board for its authorization. (Decision 376)
CACM Harmonization: Article VII (Protocol of Guatemala)
Group of Three Article 14-07.3: At the request of a party, the other Parties shall adopt reasonable measures, within their capabilities, to promote the compatibility of specific standards-related measures that exist in its territory with the standards-related measures in the territory of the other Parties, taking into account international standardization activities.
MERCOSUR  

ALADI

Article 6. The signatory countries will take such steps as are needed to notify the General Secretariat of the standardizing bodies that may accept the Code of Good Practice for the Preparation, Adoption and Application of Standards (Annex III to the WTO TBT Agreement). The signatory countries shall make every effort to promote the process of harmonization and technical standards based, preferably, on international standards that exist or are about to be adopted.

Article 7. In efforts to harmonize their standards, the signatory countries undertake to encourage, to the extent possible, the use of works performed in the region, with priority on the harmonization of those standards that are likely to have the greatest impact on intra-regional trade.

CARICOM  
CHILE & MERCOSUR Chapter X

Article 27: The Member Parties agreed on the importance of establishing a coordinated agenda and criteria in order to make compatible their standards and technical regulations.

BOLIVIA & MERCOSUR Chapter X

Article 23: The Parties shall not adopt, maintain or apply standardization measures, conformity evaluation procedures, metrological provisions, standards or sanitary, phytosanitary or environmental measures, which create unnecessary obstacles to trade.

Article 25: The Parties, when they esteem necessary, will establish a coordinated agenda and criteria in order to make compatible their standards, technical regulations, sanitary and phytosanitary measures and other related measures.

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B. Technical Regulations

WTO Article 2.6: With a view to harmonizing technical regulations on as wide a basis as possible, Members shall play a full part, within the limits of their resources, in the preparation by appropriate international

standardizing bodies of international standards for products for which they either have adopted, or expect to adopt, technical regulations.

Article 2.7: Members shall give positive consideration to accepting as equivalent technical regulations of other Members, even if these regulations differ from their own, provided they are satisfied that these regulations adequately fulfil the objectives of their own regulations.

NAFTA Article 906.2 includes a directive to make compatible technical regulations (see 'standards' above).

Article 906.4: Each importing Party shall treat a technical regulation adopted or maintained by an exporting Party as equivalent to its own where the exporting Party, in cooperation with the importing Party, demonstrates to the satisfaction of the importing Party that its technical regulation adequately fulfills the importing Party's legitimate objectives.

Article 906.5: The importing Party shall provide to the exporting Party, on request, its reasons in writing for not treating a technical regulation as equivalent under 906.4.

Andean Community Article 25: Member Countries shall gradually harmonize existing technical regulations in each Member Country. The Andean technical regulations that result from this harmonization shall be communicated by the Committee to the Board for its authorization. (Decision 376)

Article 26: Member Countries may maintain, elaborate or apply technical regulations in areas of security, protection of life, human, animal and plant health, and protection of the environment. These shall be defined as a function of the properties of use and application of the products and services to which references are made. Additionally, the Member Countries may elaborate technical regulations based on the design and descriptive characteristics of the measures to which they are found to be related to in use and application.

Such being the case, the technical regulations should specify the products to which references are made, indicating their tariff classification, requirements, procedures and the national bodies charged with overseeing their compliance. (Decision 376)

CACM Harmonization: Article VII (Protocol of Guatemala)
Group of Three Article 14-07.2: Without reducing the level of safety or of protection of human, animal or plant life or health, the environment or consumers, without prejudice to the rights of any Party under this Chapter, and taking into account international standardization activities, the Parties shall make compatible, to the greatest extent possible, their respective technical regulations and conformity assessment procedures.

Article 14-07.4: Each party shall accept a technical regulation that is adopted by another Party as equivalent to its own when, in cooperation with the importing party, the exporting Party accredits to the satisfaction of the other that its technical regulation adequately fulfills the importing Party's legitimate objectives, and being appropriate shall review it.

Article 14-07.5: At the request of the exporting Party, the importing Party shall provide its reasons for not treating a technical regulation as equivalent under paragraph 4.

MERCOSUR Resolution GMC 61/97: Negotiating Parties of Working Subgroup 3. Technical Regulations.

GENERAL TASK. Elimination of technical barriers to trade to facilitate the free circulation of goods and regional integration between the States parties.

GUIDELINES

To harmonize the technical regulations identified as barriers to trade flows within Mercosur.

To make compatible national conformity assessment Systems, Structures, and Activities, adjusting their procedures and ensuring mutual recognition in the region.

To promote the integration of the national Systems and Structures of metrology, ensuring forms of cooperation and complementarity of actions.

To define the relationship between Working Subgroup (WSG) 3 and the Mercosur Standardization Committee.

To propose procedures for organizing information relating to Technical Regulations, Technical Standards, and conformity assessment, in order to permit the desired transparency in the notification process within Mercosur and internationally.

ALADI

Article 3. The signatory countries agree to make concrete efforts to achieve harmonization of the technical regulations that may affect trade without however reducing the levels of protection for human, animal, and plant life and health, the environment, safety, and the consumer.

The technical regulations adopted by the countries shall be adjusted, basically, to the aspects mentioned above relating to human, animal, and plant life and health, safety, and consumer and environmental protection.

Article 4. In their efforts to harmonize their technical regulations, the signatory countries undertake to use, to the extent possible, the works performed in the region, with priority on the harmonization of those technical regulations that may constitute unnecessary technical barriers to intra-regional trade.

Article 5. In adopting or harmonizing technical regulations, the signatory countries shall take into account, in ensuring their compatibility, corresponding international technical regulations that exist or are about to be adopted, except where there may be specific reasons such as climate or geography or infrastructure or technological problems or constraints, that may justify a different approach.

CARICOM  
CHILE & MERCOSUR Article 27: The Member Parties agreed on the importance of establishing a coordinated agenda and criteria in order to make compatible their standards and technical regulations.
BOLIVIA & MERCOSUR Article 23: The Parties shall not adopt, maintain or apply standardization measures, conformity evaluation procedures, metrological provisions, standards or sanitary, phytosanitary or environmental measures, which create unnecessary obstacles to trade.

Article 25: The Parties, when they esteem necessary, will establish a coordinated agenda and criteria in order to make compatible their standards, technical regulations, sanitary and phytosanitary measures and other related measures.

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C. Conformity Assessment Procedures

WTO Article 6.1: Without prejudice to the provisions of paragraphs 3 and 4, Members shall ensure, whenever possible, that results of conformity assessment procedures in other Members are accepted, even when those procedures differ from their own, provided they are satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to their own procedures. It is recognized that prior consultations may be necessary in order to arrive at a mutually satisfactory understanding regarding, in particular:
  1. adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence; and
  2. limitation of the acceptance of conformity assessment results to those produced by designated bodies in the exporting Member.

Article 6.3: Members are encouraged, at the request of other Members, to be willing to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment procedures. Members may require that such agreements fulfil the criteria of paragraph 1 and give mutual satisfaction regarding their potential for facilitating trade in the products concerned.

NAFTA Article 906.2 includes conformity assessment procedures in its directive to make compatible standards-related measures (see 'standards' above).

Article 906.3 also includes conformity assessment procedures (see 'standards' above).

Article 906.6: Each Party shall, wherever possible, accept the results of a conformity assessment procedure conducted in the territory of another Party, provided that it is satisfied that the procedure offers an assurance, equivalent to that provided by a procedure it conducts or a procedure conducted in its territory the results of which it accepts, that the relevant good or service complies with the applicable technical regulation or standard adopted or maintained in the Party's territory.

Article 908.1: The Parties shall, further to Article 906 and recognizing the existence of substantial differences in the structure, organization and operation of conformity assessment procedures in their respective territories, make compatible those procedures to the greatest extent practicable.

Article 908.2: Recognizing that it should be to the mutual advantage of the Parties concerned and except as set out in Annex 908.2, each Party shall accredit, approve, license or otherwise recognize conformity assessment bodies in the territory of another Party on terms no less favorable than those accorded to conformity assessment procedures in its territory.

Article 908.3: Each Party shall, with respect to its conformity assessment procedures:

  1. not adopt or maintain any such procedure that is stricter, nor apply the procedure more strictly, than necessary to give it confidence that a good or a service conforms with an applicable technical regulation or standard, taking into account the risks that non-conformity would create;
  2. initiate and complete the procedure as expeditiously as possible;
  3. in accordance with Article 904(3), undertake processing of applications in non-discriminatory order;
  4. publish the normal processing period for each such procedure or communicate the anticipated processing period to an applicant on request;
  5. ensure that the competent body
    1. on receipt of an application, promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of any deficiency;
    2. transmits to the applicant as soon as possible the results of the conformity assessment procedure in a form that is precise and complete so that the applicant may take any necessary corrective action;
    3. where the application is deficient, proceeds as far as practicable with the procedure where the applicant so requests; and
    4. informs the applicant, on request, of the status of the application and the reasons for any delay;
  6. limit the information the applicant is required to supply to that necessary to conduct the procedure and to determine appropriate fees;
  7. accord confidential or proprietary information arising from, or supplied in connection with, the conduct of the procedure for a good of another Party or for a service provided by a person of another Party;
    1. the same treatment as that for a good of the Party or a service provided by a person of the Party; and
    2. in any event, treatment that protects an applicant's legitimate commercial interests to the extent provided under the Party's law;
  8. ensure that any fee it imposes for conducting the procedure is no higher for a good of another Party or a service provider of another Party than is equitable in relation to any such fee imposed for its like goods or service providers or for like goods or service providers of any other country, taking into account communication, transportation and other related costs;
  9. ensure that the location of facilities at which a conformity assessment procedure is conducted does not cause unnecessary inconvenience to an applicant or its agent;
  10. limit the procedure, for a good or service modified subsequent to a determination that the good or service conforms to the applicable technical regulation or standard, to that necessary to determine that the good or service continues to conform to the technical regulation or standard; and
  11. limit any requirement regarding samples of a good to that which is reasonable, and ensure that the selection of samples does not cause unnecessary inconvenience to an applicant or its agent.

Article 908.4: Each Party shall apply, with such modifications as may be necessary, the relevant provisions of paragraph 3 to its approval procedures.

Article 908.5: Each Party shall, on request of another Party, take such reasonable measures as may be available to it to facilitate access in its territory for conformity assessment activities.

Andean Community Article 15: The National Accreditation Bodies of the Member Countries shall be charged with authorizing all laboratories, certification bodies, inspection entities and persons whose services will be subregionally recognized. To guarantee the technical competence of the National Accreditation Bodies, they shall comply with procedures established by the Committee and communicated to the Board for their authorization, which shall be elaborated according to internationally accepted standards. (Decision 376)

Article 16: The National Accreditation Bodies shall establish mechanisms of supervision which guarantee the reliability of the results from the accredited bodies. Those mechanisms must not have either the objective or the effect of creating technical barriers to trade. (Decision 376)

Article 19: Member Countries and the Board of the Cartagena Agreement shall identify the capabilities of existing tests and promote their collaboration for the development of trade of products and services and the improvement of industrial production. (Decision 376)

Article 21: Member Countries shall use internationally recognized certification systems as a means of facilitating commercial and information processes and production to the consumer. In this sense, they shall harmonize the criteria of application of these certification systems, in such a way that guarantees recognition within the subregion of certificates of conformity. (Decision 376)

Article 22: In order to guarantee the technical competence in certification procedures and trade disputes, the certification authorities of the National Accreditation Bodies shall necessarily use accredited laboratories. (Decision 376)

CACM  
Group of Three Article 14-07.2: Without reducing the level of safety or of protection of human, animal or plant life or health, the environment or consumers, without prejudice to the rights of any Party under this Chapter, and taking into account international standardization activities, the Parties shall, to the greatest extent possible, make compatible their respective technical regulations and conformity assessment procedures.

Article 14-07.6: Each Party shall, whenever possible, accept the results of a conformity assessment procedure conducted in the territory of another Party, provided that it is satisfied that the procedure offers an assurance that the relevant good or service complies with the applicable technical regulation or standard adopted or maintained in the Party's territory.

Article 14-08.1: The Parties recognize the advantage of achieving reciprocal recognition of their conformity assessment systems, including accreditation bodies, in order to facilitate trade in goods and services between them and promise to work to achieve this objective.

Article 14-08.2: In addition to that established in paragraph 14-08.1, and recognizing the differences that exist in conformity assessment procedures in their respective territories, the Parties shall make compatible, to the greatest extent possible, their respective conformity assessment systems and procedures, to the effect that these be mutually reconcilable with that established in this chapter.

Article 14-08.3: For the mutual benefit and in reciprocal fashion, each Party shall accredit, approve, grant licenses or recognize conformity assessment bodies in the territory of another Party on terms no less favorable than those accorded to conformity assessment bodies in its own territory. Article 14-08.4: Each Party will give favorable consideration to a request from another Party to negotiate mutual recognition agreements of the results of the other Party's conformity assessment procedures.

Article 14-08.5: When required to carry out a conformity assessment procedure for a standard or technical regulation, each Party shall be required to:

  1. not adopt, maintain, or apply conformity assessment procedures stricter than necessary to be certain that the good or service complies with an applicable standard or technical regulation, taking into account the risks that non-conformity would create;
  2. initiate and complete the procedure as expeditiously as possible;
  3. establish a non-discriminatory order for the processing of applications;
  4. publish the normal processing period for each such procedure or communicate the anticipate processing period to an applicant on request;
  5. ensure that the competent body
    1. upon receipt of the application, promptly examine that the documentation is complete and inform the applicant in a precise and complete manner of any deficiency;
    2. as soon as possible transmit to the applicant the results of the conformity assessment procedure in a precise and complete manner such that the applicant can carry out any corrective action;
    3. when the application is deficient, proceed as far as possible when the applicant so requests; and
    4. informs the applicant, upon request, of the status of the application and the reasons for any delay;
  6. limit the information the applicant is required to supply to that necessary to conduct the procedure and to determine the appropriate fees;
  7. accord to confidential information arising from the procedure or that is supplied in connection with the procedure
    1. the same treatment as that for a good of the Party or a service provided by a person of the Party, and
    2. in any case, treatment which protects the legitimate commercial interests of the applicant;
  8. ensure that any fee that is charged for assessing the conformity of a good or service that is imported from another Party is equivalent with respect to any fee that is charged for assessment of conformity of an identical or similar good or service of the Party that is conducting the assessment, taking into consideration communication, transportation and other related costs;
  9. ensure that the location of facilities at which a conformity assessment procedure is conducted does not cause unnecessary inconvenience to the applicant or its agent;
  10. when possible, ensure that the procedure is conducted in those facilities and is accorded, when it is fitting, a mark of conformity;
  11. for a good or service that has been modified subsequent to a determination that the good or service conforms to the applicable technical regulations or standards, limit the procedure to that necessary to determine that the good or service continues to conform to the technical regulations or standards; and
  12. limit to any requirement regarding samples of a good to that which is reasonable, and ensure that the selection of the samples does not cause unnecessary inconvenience to the applicant or its agent.

Article 14-08.6: The Parties shall apply, with modifications which may arise, the provisions of 14-08.5 to their approval procedures.

MERCOSUR Resolution GMC 61/97: Conformity Assessment Committee:

To make progress towards making conformity assessment systems and structures compatible.

ALADI

Article 8. The signatory countries shall carry out such actions as are needed to establish and strengthen conformity assessment systems and to make viable the mutual recognition of conformity assessment systems, on the basis of the recommendations made by international specialized agencies such as the International Standardization Organization (ISO) and other international forums at which accreditation bodies meet such as the International Accreditation Forum (IAF) and the International Laboratories for Accreditation on Cooperation (ILAC).

Article 9. (...)

The signatory countries shall give accreditation to institutions authorized to issue results of conformity assessment procedures, in accordance with the practices established by specialized international bodies considered the most appropriate for this purpose.

Article 10. The signatory countries shall establish a harmonized system with responsibility for determining the accuracy of certificates and other documentation issued by authorized institutions and the applicable penalties in cases of fraudulent certificates, so that they may be adopted whenever two or more countries conclude an agreement of mutual recognition in conformity assessment.

Article 11. The signatory countries undertake to strengthen their conformity assessment systems and structures and to promote, to the extent possible, the use of existing laboratory capacity in the region.

CARICOM  
CHILE & MERCOSUR Article 27: (...) The Parties also agree to undertake efforts in order to identify the product areas in which the compatibility of inspection, control and conformity evaluation procedures would be possible, and which would permit the mutual recognition of the results of such procedures. Progress in the area of Standards realized under MERCOSUR will be taken into account in the Chile and MERCOSUR agreement.
BOLIVIA & MERCOSUR Article 25: (...) The Parties also agree to undertake efforts in order to identify the product areas in which the compatibility of inspection, control and conformity evaluation procedures would be possible, and which would permit the mutual recognition of the results of such procedures.

Continue to: D. Mutual Recognition


 
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