THE COMMISSION OF THE ANDEAN COMMUNITY,

CONSIDERING:

Articles 51, 55, 72 and 73 of the Cartagena Agreement and Decision 376 of the Commission.

WHEREAS:

For the purposes of perfecting the Andean System of Standardization, Accreditation, Testing, Certification, Technical Regulations and Metrology, approved in Decision 376 of the Commission, with the object of facilitating intra-subregional trade through improved quality of the products and services and the elimination of technical restrictions on trade, it proves necessary to modify the procedures for denouncing technical obstacles to trade and notification of obligatory technical standards, technical regulations, conformity evaluation procedure or other measures of an obligatory nature to be adopted by the Member Countries;

HEREBY DECIDES:

Article 1: Replace Article 8 of Decision 376 with the following text:

"Article 8. Should a Member Country consider that a technical regulation, obligatory technical standard, conformity evaluation procedure, obligatory certification or any other equivalent measure that has been adopted or that another Member Country might intend to adopt, constitute a restriction on trade according to the terms established in Article 72 of the Agreement, consultations may be held with the Member Country that had adopted, adopts or intends to adopt the measure, to request the technical intervention of the Committee or to resort to the General Secretariat of the Andean Community for same to pronounce judgment in accordance with the terms set out in Article 73 of the Cartagena Agreement.

The holding of consultations, the technical intervention of the Committee or the pronouncement by the General Secretariat may not exceed thirty working days from the date of receipt of the corresponding request. In the event that the consultations or the intervention of the Committee do not resolve the matter within the indicated period or resolve same only partially, the Member Country or the interested party may present the same case to the General Secretariat of the Andean Community.

When considering the case, the General Secretariat may request the technical opinion of the members of the Committee or of the corresponding ad hoc Committees. In the event that the General Secretariat finds that there exists a restriction on trade, it shall order the removal of the measure."

Article 2: Suppress Article 27 of Decision 376.

Article 3: Insert a new Chapter in Decision 376, continuing on after the current Chapter VIII, having the following text:

"Chapter IX Notifications

Article: Each Member Country shall notify the other Member Countries, through the General Secretariat of the Andean Community, of the new technical regulations, obligatory technical standards, conformity evaluation procedure, obligatory certifications and any other equivalent obligatory measure that it is intended to adopt, at least ninety days before the application of said measures to intra-subregional trade of products. The notification within the indicated period, shall be a necessary requisite to demand its compliance by other Member Countries.
In urgent cases, Member Countries may adopt technical regulations, obligatory technical standards, conformity evaluation procedures, obligatory certifications or other equivalent obligatory measures, without adhering to the period referred to in the previous paragraph. In these cases, the Member Country that adopts the measure, shall immediately notify the other Member Countries, through the General Secretariat of the Andean Community.

In any case, the Member Country that applies the measure shall, without discrimination, give the other Member Countries the possibility of formulating written observations, holding consultations on them if they so wish, and shall take into account these written observations and the results of said conversations.

Once the urgency ceases, and in any case within a period not to exceed twelve months after the issuance of a measure of urgency, the Member Country that applies the measure shall derogate it in order to permit the free flow of trade.

Article: Member Countries and the General Secretariat of the Andean Community may request from the notifying Member Country information and clarifications they deem pertinent, regarding the measures notified. The notifying Member Country shall supply such information and clarifications as necessary to the one requiring same. In the event that the information or clarification shall have been required by a Member Country, the notifying country shall inform on the results of the consultations with the General Secretariat.

Likewise, as covered in the previous paragraph, the Member Countries and the General Secretariat may request further information or clarifications they deem pertinent regarding internal measures that do not require to be notified, for the purposes of determining their possible effects on the intra-subregional trade of products."

Article�4: Published after the continuation of the present Decision, the entire text of the Decision on the Andean System of standardization, Accreditation, Testing, Certification, Technical Regulations and Metrology, with the modifications introduced here. To this end, substitute all mentions made in the referred-to Decision to the Board of the Cartagena Agreement by the General Secretariat of the Andean Community, and correct the numbering of the Agreement's articles.

Given in the city of Lima, Peru, on the thirtieth day of the month of July in the year nineteen hundred and ninety-seven.

Decision 376 (Modified)
Andean System of Standardization, Accreditation, Testing, Certification, Technical Regulations and Metrology

THE COMMISSION OF THE ANDEAN COMMUNITY,

CONSIDERING: Articles 51, 55, 72 and 73 of the Agreement, Decision 180 of the Commission and Proposal 271 of the Board;

WHEREAS:

During the Thirtieth Period of Extraordinary Sessions of the Commission, held from July 6 to 9, 1983, the Andean Subregional System for Coordination of Activities of Technical Standardization, Certification of Quality and Metrology was created, approved by Decision 180 of the Commission of the Cartagena Agreement;

Given the advance made in the Andean integration process and considering the new developments in the treatment of Standardization, accreditation, Testing, certification, technical regulations and metrology, as well as in the regulation of technical restrictions on trade, it becomes necessary to establish a wider normative framework;

In addition, the Standardization, accreditation, Testing, certification, technical regulations and metrology constitute tools essential for the development of the Subregion, in view of the fact that they foster progressive improvement in the quality of products and services that are interchanged in international trade, and for the protection of health, safety, the environment and consumer protection;

For proper treatment of the terms indicated in the previous paragraph, it is advisable to initiate a gradual harmonization process; and

It is necessary, moreover, to ensure that the measures that are adopted by the Member Countries in the cited matters are applied in such a way so as not to constitute a means of discrimination or a blanket restriction on trade;

HEREBY DECIDES:

CHAPTER I
SYSTEM, OBJECTIVES AND ADMINISTRATION

Article 1: To create the Andean System of Standardization, Accreditation, Testing, Certification, Technical Regulations and Metrology, which shall be governed by the terms set out in the present Decision and which shall hereafter be called the System.

Article 2: The object of the System is to facilitate intra-subregional trade, through the improvement of the quality of products and services, and the removal of technical restrictions to trade.

Article 3: In order to attain the objective indicated in the preceding article, the System:

a) Shall coordinate, develop and harmonize at a subregional level, the activities standardization, testing, accreditation, certification, technical regulations and metrology within the priorities of the integration process;

b) Shall supply the technical elements required for the consideration or approval of technical regulations;

c) Shall consider, within the development of its activities, those aspects regarding safety, health, environment preservation and consumers protection; and,

d) Shall project, at a regional and international level, the progress made by the Andean Group in this field, and promote the entering into international covenants and agreements.

Article 4: The standardization, accreditation, testing, certification, technical regulations and metrology activities, comprised by the System, shall be applicable to all the products and services made or traded in the Subregion, without considering the phytosanitary and zoosanitary aspects, or other aspects already ruled by a particular Decision. These activities shall be coordinated with the Competent National Bodies appointed by law in each Member Country.

Article 5: To support the activities of the System, the subregional Committee of Standardization, Accreditation, Testing, Certification, Technical Regulations and Metrology, is hereby created, and shall be hereinafter referred to as the Committee.

Article 6: The Committee shall be formed by a main and a deputy representative from each Member Country, both of them accredited before the General Secretariat of the Andean Community by the Liaison Bodies. Its operating shall be ruled according to the provisions in Annex I.

Ad hoc Committees could be formed to deal with specialized issues connected to this Decision, the same which shall be ruled by the provisions in Chapter III of Annex I.

CHAPTER II
GENERAL PROVISIONS

Article 7: The standards, technical regulations and procedures for the evaluation for conformity which the Member Countries make, adopt, apply, or maintain, shall not have the objective of effect to create technical obstacles to intrasubregional trade.

Article 8: Should a Member Country consider that a technical regulation, obligatory technical standard, conformity evaluation procedure, obligatory certification or any other equivalent measure that has been adopted or is intended to be adopted by a Member Country, constitutes a restriction on trade in accordance with the terms established in Article 72 of the Agreement, it may enter into consultations with the Member Country that has adopted, adopts or intends to adopt the measure, to request the technical intervention of the Committee or even to resort to the General Secretariat of the Andean Community so that same pronounce themselves in agreement with the terms set out in Article 73 of the Cartagena Agreement. For their part, private interested parties may similarly resort to the General Secretariat of the Andean Community for same to pronounce itself in agreement with the terms set out in Article 73 of the Cartagena Agreement.

The holding of consultations, the technical intervention of the Committee or the pronouncement by the General Secretariat may not exceed thirty working days from the date of reception of the corresponding request. In the event that the consultations or the intervention of the Committee does not resolve the matter within the period indicated or resolves it only partially, the Member Country or interested party may present the same case to the General Secretariat of the Andean Community.

When considering the case, the General Secretariat may request the technical opinion of the members of the Committee or of the corresponding ad hoc Committees. In the event that the General Secretariat finds that there exists a restriction on trade, it shall order the removal of the measure.

Article 9: Under this Decision, the Member Countries shall give those products which are original from, and services provided by, another Member Country a non less favorable treatment than that given to similar national products or services, or to products and services from third countries.

CHAPTER III
STANDARDIZATION

Article 10: The Member Countries shall gradually harmonize the national standards in force in each country or adopt those which they consider of subregional interest. This process shall result in Andean standards, which shall be communicated by the General Secretariat of the Andean Community, so that they become official.

Article 11: Each Member Country shall notify the other Member Countries through the General Secretariat of the Andean Community, of the commencement of any activity leading to the publication of a standard, as well as the text thereof, once it has been elaborated.

Article 12: The Member Countries shall use, as reference, international, regional or national standards from other countries in their standard adoption process. Without prejudice to the aforementioned, they shall be able to elaborate standards which are of national interest.

Article 13: The procedures of the harmonization, elaboration, notification, modes of registration and structure of Andean Standards shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

Article 14: The Andean Standardization Network is hereby created. It shall be formed by the National Standardization Bodies from the Member Countries. The regulations for the operating of the Network's shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

CHAPTER IV
ACCREDITATION

Article 15: The National Accreditation Bodies from the Member Countries shall be in charge of authorizing those laboratories, certification bodies, inspection entities and persons whose services shall be subregionally acknowledge.

In order to guarantee the technical competence of the National Accreditation Bodies, these should comply with the procedures established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official. The said procedures shall be elaborated in accordance with internationally accepted standards.

Article 16: The National Accreditation Bodies shall establish supervision mechanisms which guarantee the reliability of the results of the bodies accredited thereby. The said mechanisms shall not have the objective or effect of creating technical restrictions to trade.

Article 17: The Andean Network of National Accreditation Bodies is hereby created. The regulations for the opening of the Network shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

Article 18: Each Member Country shall notify the other Member Countries, through the General Secretariat of the Andean Community, about the National Accreditation Bodies as well as the bodies and people accredited thereby, indicating the corresponding scopes.

CHAPTER V
TESTING

Article 19: he Member Countries and the General Secretariat of the Andean Community shall identify the existing testing capabilities and promote their action for the development of the trade of products and services, as well as for the improvement of industrial production.

Article 20: The Andean Network of Testing Laboratories is hereby created. It shall be formed by the laboratories accredited by the National Accreditation Bodies.

The regulations for the operating of the Network shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

CHAPTER VI
CERTIFICATION

Article 21: The Member Countries shall use the internationally acknowledged certification systems, in order to facilitate productive, commercial, and consumer information processes. With regard thereto, the criteria for the application of the said certification systems shall be harmonized, in such a way that they guarantee the acknowledgement of the certificates of conformity in the Subregion.

Article 22: In order to guarantee the technical competence in the certification and trade dispute procedures, the certifiers authorized by the National Accreditation Bodies shall necessarily use accredited laboratories.

Articles 23: The General Secretariat of the Andean Community shall set up a Register of certifying bodies, accredited by the National Accreditation Bodies.

Article 24: The Andean Network of Accredited Certification Bodies is hereby created. The regulations for the operating of the Network shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

CHAPTER VII
TECHNICAL REGULATIONS

Article 25: The Member Countries shall gradually harmonize the technical regulations in force in each Member Country. The Andean technical regulations which result from this harmonization shall be communicated to the General Secretariat of the Andean Community by the Committee, so that they become official.

Article 26: The Member Countries shall be able to maintain, elaborate or apply technical regulations regarding safety; life protection; human, animal and plant health; and, environmental protection. These shall be defined in accordance with the properties of use and employment of the products and services they refer to.

Additionally, they shall be able to elaborate technical regulations based on the design and descriptive characteristics, as long as these are connected to the use and employment.

Likewise, the technical regulations shall specify the products they refer to, indicating their classification, requirements, procedures, and national bodies in charge of looking after their fulfillment.

Article 27: The procedures for the harmonization, elaboration, modes of notification and previous consultation, as well as the structure and terms of application of the national or Andean technical regulations shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

CHAPTER VIII
METROLOGY

Article 28: The Member Countries and the General Secretariat of the Andean Community shall identify the existing metrology capabilities and promote their action for the development of the trade of products and services, as well as for the improvement of industrial production.

Article 29: The Andean Metrology Network is hereby created. It shall be formed by institutions or organizations which carry out metrology activities as well as by calibration laboratories accredited by the National Accreditation Bodies. The regulations for the operating of the Network shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

Article 30: The Member Countries shall harmonize the metrological standards, regulations and procedures which support the traceability of the calibration patterns and systems at the Andean level.

The harmonization procedures shall be established by the Committee and communicated to the General Secretariat of the Andean Community, so that they become official.

Article 31: The Member Countries adopt the International System of Units as the Official System of Units of Measure in the Andean Subregion. With regard thereto, they shall propitiate activities, in coordination with the General Secretariat of the Andean Community, for its diffusion and full application in all sectors of public and private activity.

CHAPTER IX
NOTIFICATIONS

Article 32: Each Member Country shall notify all the other Member Countries through the General Secretariat of the Andean Community of the new technical regulations, obligatory technical standards, conformity evaluation procedures, obligatory certifications and any other equivalent obligatory measure it intends to adopt, at least ninety days before the application of said measures on intra-subregional trade of products. The notification within the indicated period, shall be a necessary requisite to demand its compliance by other Member Countries comply with it.

In urgent cases, Member Countries may adopt technical regulations, obligatory technical standards, conformity evaluation procedures, obligatory certifications or other equivalent obligatory measures, without adhering to the period referred to in the previous paragraph. In these cases, the Member Country that adopts the measure shall immediately notify the other Member Countries through the General Secretariat of the Andean Community.

In any case, the Member Country that applies the measure shall, without discrimination, give the other Member Countries the possibility of formulating written observations, holding consultations on them if they so wish, and take into account these written observations and the results of said conversations.

Once the urgency ceases and in any case within a period not to exceed twelve months after the issuance of a measure of urgency, the Member Country that applies the measure shall derogate it to permit the free flow of trade.

Article 33: Member Countries and the General Secretariat of the Andean Community may request from the notifying Member Country further information and clarifications they deem pertinent, regarding the measures notified. The notifying Member Country shall supply such information and clarifications that are necessary to the one requiring same. In the event that the information or clarification shall have been required by a Member Country, the notifying country shall inform on the results of the consultation with the General Secretariat.

Likewise, as covered in the previous paragraph, the Member Countries and the General Secretariat may request further information or clarifications they deem pertinent, regarding internal measures that do not require to be notified, for the purposes of determining their possible effects on intra-subregional trade of products.

CHAPTER X
FINAL PROVISIONS

Article 34: The Member Countries shall be able to enter into agreements among themselves, as long as the objective or effect thereof is to promote, perfect, harmonize, or achieve the automatic acknowledgement of the systems, regulations, procedures and consultation mechanisms, in accordance with the provisions herein. The said agreements shall be open to the participation of the other Member Countries.

Article 35: The Andean Training Program shall be established, so as to train and qualify the human resources which support the operation of the System.

Article 36: The Information and Registration Center for standards, technical regulations, procedures for the evaluation for conformity, entities of the System, as well as for other legal provisions and general information which may be pertinent for the objectives pursued by the System, is hereby created.

Article 37: The terms used in this Decision shall be defined according the Glossary in Annex II.

Article 38: Have Decision 180 derogated.

CHAPTER XI
TRANSITORY PROVISION

Article 39: The Committee shall establish the procedures for harmonization, elaboration of Andean standards, regulations, accreditation of bodies and people, opening of Andean registers, certification, establishment of Andean Networks; and other actions necessary to develop what has been established in this Decision, within a twelve month term, counted as from the date of its publication.

ADDENDUM I

REGULATIONS OF THE ANDEAN COMMITTEE FOR STANDARDIZATION, ACCREDITATION, TESTING, CERTIFICATION, TECHNICAL REGULATIONS AND METROLOGY

Article 1: The Committee shall be chaired by the principal representative of the country that is exercising the Chairmanship of the Commission during the corresponding period.

I. Functions

Article 2: Following are the functions of the Committee:

a) To support the System's arrangements;

b) To counsel the General Secretariat of the Andean Community on aspects related to the System;

c) To establish coordination, cooperation and harmonizing mechanisms, proper to achieving the System's objectives;

d) To establish and coordinate development of the harmonizing of programs of matters dealt with in the present Decision;

e) To define periodical auditing procedures of National Accreditation Bodies; such procedures shall be issued by the General Secretariat of the Andean Community through resolutions;

f) To set up Working Groups to study specific technical aspects that so require;

g) To analyze the reports of the Working Groups and make recommendations they deem advisable, which shall preferably be adopted by consensus or, should no agreement on same be reached, by a voting procedure;

h) To recommend the dates and places for holding the ordinary and extraordinary meetings of the Committee and to approve the agenda of same;

i) To issue technical opinions at the request of the General Secretariat of the Andean Community in the event that differences arise between Member Countries at the time of applying the present Decision;

j) To coordinate, advance and foster actions of dissemination and promotion, tending to favor the achievement of the objectives aimed at in the present Decision;

k) To promote the application of norms and procedures for evaluating the conformity of the Member Countries;

l) To formulate proposals and to adopt joint positions that are of interest to the Member Countries, to be presented to regional and international forums which deal with issues related to this Decision; and

m) Other matters that arise from the present Decision or by Commission mandate.

Article 3: It is up to the Chairman of the Committee:

a) To convoke the Committee's ordinary and extraordinary meetings when the circumstances so require;

b) To verify the quorum of at least three Member Countries to open the Committee session;

c) To propose the agenda for the meeting;

d) To propose the constitution of Working Groups, to define their functions and that of the members comprising same, and to fix the latest date for holding the meetings;

e) To propose to the Committee the annual work place and to coordinate its execution;

f) To represent the Committee in cases that are delegated to it; and

g) Other matters assigned to the Committee.

Article 4: The Technical Secretariat of the Committee shall be the job of a functionary designated by the General Secretariat of the Andean Community, whose functions will be as follows:

a) To collaborate with the Chairman in formulating the Committee's annual work plan;

b) To constitute and arrange the tasks of the Information and Registration Center for norms, regulations and other legal provisions and general information that proves to be pertinent for the purposes pursued by the System;

c) To coordinate with the Competent National Bodies the execution of the work plan;

d) To coordinate the technical and administrative assistance required by the Committee;

e) To draft and remit the final minutes of the Committee meetings and to make known to the Competent National Bodies, the task and actions approved by it;

f) To negotiate before the General Secretariat of the Andean Community requests presented by Member Countries on removal of technical restrictions on trade;

g) To present to the Cartagena Agreement Commission an annual report on Committee action;

h) To represent the Committee in cases that are delegated to it, according to their competence; and

i) Other matters that are assigned by the Committee or by community provisions.

Article 5: The Competent National Bodies are responsible for the following:

a) To coordinate and carry out actions at the national level deriving from the present Decision and to act together with the Committee;

b) To propose to the Committee matters requiring their consideration;

c) To designate experts to make up the Working Groups referred to in these Regulations;

d) To remit annually to the Technical Secretariat of the Committee, reports on the activities of Standardization, accreditation, Testing, certification, technical regulations and metrology of their country and the state of their progress; and

e) To keep the national registers of institutions updated, as well as personnel accredited according to the present Decision.

II. Sessions

Article 6: The Committee shall meet in ordinary session twice a year and in extraordinary session at the request of the General Secretariat of the Andean Community, a Member Country or by Commission mandate.

Article 7: The Committee shall meet at the headquarters of the General Secretariat of the Andean Community or in any Member Country, if so agreed upon.

Article 8: The convoking of a meeting of the Committee should be notified to the Competent National Bodies and to the principal representatives, at least three weeks in advance, together with the draft agenda and the necessary working documents.

Member Countries may request the inclusion of other issues on the agenda, ensuring that the respective documents for same reach the General Secretariat of the Andean Community and other Member Countries well in advance.

The Committee shall approve the agenda to be dealt with, at the beginning of the meeting.

Article 9: The Committee shall have the affirmative vote of at least three of its members in order to approve agreements.

III. Ad hoc Committees

Article 10: Ad hoc Committees shall be formed by experts in a specific sector, who shall be accredited by the Liaison Body of each Member Country and may be convoked by the Commission, the General Secretariat of the Andean Community, the Committee or at the request of any Member Country.

ADDENDUM II

GLOSSARY OF TERMS

Accreditation: proceeding by which an authorized body formally recognizes that a person or institution is competent to carry out specific tasks.

Calibration: set of operations that establish, under specified conditions, the relation between the values of magnitudes indicated by a measuring instrument or by a measuring system, or the values represented by a materialized measure or by a reference material, and the corresponding values determined by means of patterns.

Certificate of Conformity: document issued according to the rules of a certification system, in which it is reasonably attested that a duly identified product, process or service is according to a norm, technical specification or other specifically normative document.

Certification: procedure by which a third party attests in writing that a product, process or service is in accordance with established requisites.

Conformity Evaluation Procedure: any procedure utilized, directly or indirectly, to determine that pertinent prescriptions of technical regulations or norms are complied with.

NOTE:

Procedures for evaluating conformity cover, among other things, those of sampling, testing and inspection, evaluation, verification and guarantee of conformity, registration, accreditation and approval, separately or in different combinations.

Inspection: activities such as measuring, examining, Testing or comparing with patterns one or various features of an entity or comparing the results with the established requisites, with the purpose of determining whether conformity is obtained for each one of these features.

International norm: norm adopted by an international Standardization body and made available to the public.

International Units System: coherent system of units adopted and recommended by the General Conference of Weights and Measures.

Measurement pattern: materialized measure, measuring instrument, reference material or measuring system, aimed at defining, carrying out, preserving or reproducing a unit or one or more known values of a certain magnitude to serve as reference.

Metrology: science of measuring.

NOTE:

Metrology includes technical and practical aspects related to measurements, whatever their uncertainty is and whatever the field of science or of technology to which it is applied.

Norm: document, established by consensus and approved by an authorized body, that provides for common and repeated use, rules, directives or features of the activities or their results, in order to guarantee optimal order within a given context.

NOTE:

Norms should be based on the consolidated results of science, technology and experience to obtain optimum benefits for the community, and are of voluntary application.

Quality: the totality of features of a body that confers on it the aptitude to satisfy explicit and implicit needs.

Regulation: document that contains rules of an obligatory nature, that is approved by a competent authority.

Technical regulation: regulation that contains technical requisites or makes reference to technical standards or specifications or codes of practice or which make up their content.

Traceability: property of the result of a measurement or the value of a pattern by virtue of which this result can be related to stipulated references, generally national or international patterns, through an uninterrupted chain of comparisons that have determined all uncertainties.

NOTES:

1. The concept is often expressed using the adjective traceability.

2. The uninterrupted chain of comparisons is called the traceability chain.

3. The manner in which the interrelation is carried out with patterns is called "joining against patterns".