G/TBT/2/Add.18/Rev.1/Suppl.2  
12 October 2015  
(15-5332)  Page: 1/7  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT ON 
TECHNICAL BARRIERS TO TRADE 
COMMUNICATION FROM COLOMBIA 
Supplement 
The following communication, dated 6 October 2015, is being circulated at the request of the 
delegation of Colombia. 
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 1.1.  In accordance with Article 15.2 of the WTO Agreement on Technical Barriers to Trade 
(TBT Agreement) and the transparency commitmen ts undertaken by Colombia, the Government of 
the Republic of Colombia hereby informs the Committee on Technical Barriers to Trade of the 
following measures relating to standardization, technical regulations, accreditation, conformity assessment and metrology, as well as implementation and administration of the TBT Agreement: 
1.2.  On 5 August 2015, the National Government issued Decree No. 1595 " Adopting regulations 
for the National Quality Subsystem and amending Chapter 7 and Section 1 of Chapter 8 of Title 1 of Part 2 of Book 2 of the Single Decree Regula ting the Commerce, Industry and Tourism Sector, 
Decree No. 1074 of 2015, and adopting other provisions" , which came into force on 
6 October 2015. The following are among its provisions: 
ARTICLE 1.1.3.19 Colombian Technical Standa rds and Certification Institute – ICONTEC 
The Colombian Technical Standards and Certification Institute – ICONTEC – shall be the body 
responsible to the National Government for evaluation and coordination in the area of technical 
standardization; (…) 
ARTICLE 1.1.3.20 National Ac creditation Organization 
Colombia's National Accreditation Organization – ONAC – shall be the entity responsible for 
accrediting the technical competence of conformity assessment bodies. (…) 
1  CHAPTER 7: NATIONAL QUALITY SUBSYSTEM 
1.1  SECTION 1: GENE RAL PROVISIONS 
Article 2.2.1.7.1.1 Purpose 
The purpose of this Chapter is to restructure the National Quality Subsystem – SNCA in relation to 
standardization, technical regulations, accred itation, conformity assessment, metrology, 
monitoring and control. (…) 
ARTICLE 2.2.1.7.1.5 Objectives of the SNCA The following are the basic objectives of the National Quality Subsystem (SNCA): 
1. To promote the safety, quality, trustworthiness, innovation, productivity and 
competitiveness of production sectors and importers of products in the market. 
2. To protect the interests of consumers. 
3. To facilitate market access and trade. G/TBT/2/Add.18/Rev.1/Suppl.2 
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  4. To assist the system's users to protect the health and life of persons and animals and the 
conservation of plants. 
5. To protect the environment and national security. 
6. To prevent practices likely to mislead consumers. 
1.2  SECTION 2: DEFINITIONS 
ARTICLE 2.2.1.7.2.1 Definitions 
Without prejudice to the provisions in Andean deci sions and legislation, for the purposes of this 
Chapter the definitions below shall be used and, wh ere these differ from the definitions in ISO/IEC, 
BIPM or OIML international standards, including VIM and VIML, the latter shall prevail: (…) 
Legal time in the Republic of Colombia . This is the legal time in effect throughout the territory of 
the Republic of Colombia, determined by the National Government and disseminated by the 
National Institute of Metrology. (…) 
Regulatory impact analysis report (RIA) . Document to be drawn up by the competent regulatory 
authorities in order to summarize the procedure and the results obtained from the regulatory 
impact analysis when preparing and issuing technical regulations, based on the format laid down 
by the Ministry of Commerce,  Industry and Tourism. (…) 
List of problem areas . Document identifying the products associated with the major problems 
jeopardizing Colombia's legitimate objectives under the WTO Agreement on Technical Barriers to 
Trade, to be used as input when preparing the Annual Regulatory Impact Analysis Plan – PAAIN. 
(…) 
Colombian technical standard . Technical standard approved or adopted as such by Colombia's 
National Standardization Organization. 
International standard . Technical standard adopted by an international standardization 
organization and made available to the public. (…) 
Conformity certificates information system – SICERCO . Public register administered by the 
Supervisory Authority for Industry and Trade in which accredited certification and inspection bodies register the conformity certificates and insp ection reports, as applicable, issued by them for 
products subject to compliance with technical regulations monitored by the Supervisory Authority. 
SUIN – JURISCOL. Single System  of Regulatory Information of the Colombian State, administered 
by the Ministry of Justice and Law. (…) 
1.3  SECTION 3: STANDARDIZATION 
ARTICLE 2.2.1.7.3.1 Standardization 
Colombia's technical standardization shall be developed by the National Standardization 
Organization, which shall have the responsibilities set out in this Chapter. 
The Colombian Technical Regulations and Certification Institute – ICONTEC shall act as the 
National Standardization Organization. (…) 
ARTICLE 2.2.1.7.3.9 Incorporation of tec hnical standards in technical regulations 
Where a Colombian technical standard is utilized as a whole or in part as the basis for a technical 
regulation or other mandatory measure, the regulatory entity may incorporate it in full or in part in 
the technical regulation or in another mandatory measure. For these purposes, the National Standardization Organization shall supply the corresponding standard. (…) 
1.4  SECTION 5: TECHNICAL REGULATIONS 
ARTICLE 2.2.1.7.5.1 Guidelines for technical regulations 
Regulatory entities shall adopt good technical regulation practices in such a way that they have 
neither the intention nor the effect of creating unnecessary obstacles to trade. 
The provisions contained herein supplement th ose on transparency, consultations and good 
international practices. G/TBT/2/Add.18/Rev.1/Suppl.2 
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  ARTICLE 2.2.1.7.5.2 Reference to national  and international technical standards 
Technical regulations shall be based on international technical standards. Likewise, national 
technical standards harmonized with international technical standards may serve as a reference for technical regulations. The foregoing shall apply unless one or the other proves ineffective or 
inappropriate for the protection of the legitimate objectives indicated in the World Trade 
Organization's Agreement on Technical Barriers to Trade. In such cases, the technical regulation shall be backed up by scientific evidence. (…) 
ARTICLE 2.2.1.7.5.6 Request for a prior opinion 
In order to proceed with notifying a draft technical regulation or conformity assessment procedure, 
in the terms of the World Trade Organization's Agreement on Technical Barriers to Trade, regulatory entities shall seek the opinion of th e Department of Regulation of the Ministry of 
Commerce, Industry and Tourism as regards complian ce with the guidelines of the National Quality 
Subsystem and the potential for creating unnecessary technical barriers to trade with other countries. Such a request shall be accompanied by a list of problem areas and the PAAIN. (…) 
ARTICLE 2.2.1.7.5.10 Notification 
All draft technical regulations and conformity a ssessment procedures shall be notified through 
Colombia's enquiry point to Members of the Worl d Trade Organization, the Andean Community and 
countries with which Colombia has signed trade agreements in force which contain a notification 
clause. 
For this purpose, each regulatory entity shall send  to the Department of Regulation of the Ministry 
of Commerce, Industry and Tourism the draft te chnical regulation or conformity assessment 
procedure for the corresponding notification. Any amendments to draft technical regulations or 
conformity assessment procedures shall also be no tified if their impact makes the situation more 
onerous for the person regulated or for users. 
Paragraph 1. Any amendment or addition to the content of a technical regulation that has not been 
notified shall require notification of the technical regulation in full. 
Paragraph 2. After a technical regulation has been issued, the regulatory entity shall forward the 
corresponding administrative act to Colombia 's TBT/SPS enquiry point for notification. 
Paragraph 3. Pursuant to Article 72 of Law No. 1480 of 2011, no technical regulation may be 
published in the Official Journal, and consequently may not enter into force, without the certification issued by Colombia's TBT/SPS enquiry point, except for the adoption of emergency or 
urgent technical regulations. (…) 
ARTICLE 2.2.1.7.5.13 Determ ination of equivalence 
Regulatory entities shall have authority to determine the equivalence of technical regulations, 
following a technical study substantiating it. If ne w equivalence is found subsequent to the issue of 
a technical regulation, the regulator responsible shall incorporate it into the technical regulation by means of an amendment thereto. (…) 
1.5  SECTION 6: PREPARATION AND IS SUE OF TECHNICAL REGULATIONS 
ARTICLE 2.2.1.7.6.6 Risk levels 
In analysing the regulatory impact, regulatory entities shall identify and define the risks according 
to the appropriate levels of protection relating to the legitimate objectives. Risk levels are 
classified as follows: 
Low risk: Little likelihood of occurrence and low impact. 
Medium risk: High likelihood of occurrence and low impact or low likelihood of occurrence and high 
impact. 
High risk: High likelihood of occurrence and high impact. 
If the measure to be adopted is a technical regulation, except in special and justified cases 
identified by the regulator, the risk level identified in the regulatory impact analysis shall be used 
as a general criterion when determining conformity, for example: G/TBT/2/Add.18/Rev.1/Suppl.2 
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  1. Low risk: First party conformity declaration according to the terms and conditions in 
Colombian Technical Standard NTC–ISO/IEC 17050, parts 1 and 2, and updates or amendments thereto; and 
2. Medium and high risk: Third party Confor mity Certificate by accredited body. 
Paragraph . With the submission of a first party conformity declaration, it is assumed that the 
declarant has itself undertaken the verification, inspection and testing required by the technical regulation and shall, therefore, be responsible for the products' conformity with the specific 
requirements in the pertinent technical regulation, in accordance with NTC–ISO/IEC 17050 – parts 
1 and 2 and updates or amendments thereto. (…) 
1.6  SECTION 7: ACCREDITATION 
ARTICLE 2.2.1.7.7.1 Purpose of accreditation 
The purpose of accreditation is to issue a third party declaration regarding a conformity 
assessment body which provides formal proof of its competence to conduct specific conformity 
assessment activities. 
ARTICLE 2.2.1.7.7.3 Function of the National Accreditation Organization 
The principal function of the National Accreditation Organization is to provide accreditation services 
to conformity assessment bodies, in accordance with national and international accreditation 
standards whose scope includes technical regulations, technical standards and other regulatory 
documents. (…) 
ARTICLE 2.2.1.7.7.5 Recognition of accreditation Accreditation shall be recognized within the National Quality Subsystem – SNCA provided that it 
has been granted by Colombia's National Accredit ation Organization or by public bodies which 
legally exercise such responsibilities, or by foreign accreditation bodies recognized under multilateral recognition agreements, as provided in Section 9 of this Chapter. 
ARTICLE 2.2.1.7.7.6 Representation by th e National Accreditation Organization 
Colombia's National Accreditation Organization shall represent and act on behalf of Colombia in the 
Andean Community and multilateral accreditation forums and shall take part in regional and 
international institutions and activities involved in accreditation, without prejudice to the 
competence of government bodies in this sphere. (…) 
1.7  SECTION 8: CONFORMITY ASSESSMENT BODIES 
ARTICLE 2.2.1.7.8.1 Action by conformity assessment bodies 
Conformity assessment bodies situated in Colombia shall be accredited by the National 
Accreditation Organization by means of a regula tory document for the purpose of conducting 
conformity assessment activities in respect of a technical regulation, for example, certification, 
inspection, sampling/testing and calibration, or the conduct of proficiency tests and other 
accreditation activities. If the National Accreditation Organization does not possess the technical competence to accredit a body in a particular field, it may turn to the system defined for 
cross-border accreditation in order to provide the service in Colombia. Conformity assessment 
bodies situated abroad shall be subject to the provisions in Article 2.2.1.7.9.2, paragraphs 2, 3 and 4 of this Decree. 
Paragraph. Entities which have engaged in adviso ry or consultancy work for the same natural or 
legal person in relation to any aspect concerning the subject of the conformity assessment may 
not conduct certification and inspection activities. 
ARTICLE 2.2.1.7.8.2 Issue of  conformity certificates 
Certification bodies shall issue a conformity certificate after examining compliance with the 
specified requirements. Supporting documents for the issue of certificates of conformity with technical regulations shall contain as a minimum: objective proof of verification of all the 
requirements specified for the technical regulation, with the corresponding documentary records, 
the testing methods, the sampling programme, the re sults of the assessment, identification of the 
products or categories of product, the period and scheme of certification used, in accordance with NTC-ISO/IEC 17067 or its replacement. (…) G/TBT/2/Add.18/Rev.1/Suppl.2 
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  1.8  SECTION 9: CONFORMITY ASSESSMENT PROCEDURE 
ARTICLE 2.2.1.7.9.2 Procedure for asse ssing the conformity of products 
Pursuant to the World Trade Organization's Agreement on Technical Barriers to Trade, prior to 
marketing, domestic producers and importers of products subject to technical regulations shall 
obtain the relevant conformity certificate, which shall be valid in Colombia provided that it has 
been obtained using one of the following alternatives: 
1. It has been issued by a certification body accredited with the National Accreditation 
Organization and the scope of accreditation includes the product and the technical 
regulation. 
2. It has been issued by a foreign certification body, accredited by an accreditation body 
recognized under the multilateral recognition agreements to which Colombia's National 
Accreditation Organization is party, provided that the issuing country accepts Colombian 
certificates for domestic products. The Ministry of Commerce, Industry and Tourism shall be responsible for regulating this aspect. The re gulatory entity may require an additional 
verification procedure at the national level. 
3. It has been issued by a certification body a ccredited by an accreditation body recognized 
under a multilateral recognition agreement to which the National Accreditation Organization 
is not party. Such conformity certificates may be recognized subject to evaluation by 
certification bodies accredited in Colombia whose scope includes the product and technical regulation. The certification body accredited in Colombia shall verify the scope of the accreditation and may declare conformity with the requirements specified in the 
corresponding Colombian technical regulation and those accepted as equivalents. 
The conformity assessment body in Colombia which recognizes the results of conformity 
assessment issued by a foreign accredited co nformity assessment body shall prove to the 
National Accreditation Organization that it has an agreement with its counterpart 
guaranteeing its competence to carry out the conformity assessment abroad. 
4. It has been issued under a mutual recognition agreement signed between Colombia and 
another country and in force. 
Paragraph 1. It shall be understood that a conformity assessment body which recognizes the 
certificates of a third party shall assume responsibility for such certificates so that it has the same responsibilities as those for certificates it issues directly. 
Paragraph 2. Regulatory entities shall include in technical regulations the alternatives provided in 
this Article and shall determine the documents valid, together with an applicable NTC-ISO/IEC 17067 certification scheme to prove the product's conformity with the relevant 
technical regulation. 
Paragraph 3. Domestic producers and importers of products subject to technical regulations in 
force which do not specify the type of conformi ty certificate shall apply one of the schemes 
determined in NTC–ISO/IEC 17067 and additions or amendments thereto, as well as the provisions 
in this Article. 
Paragraph 4. If a conformity certificate issued in accordance with this Article proves compliance 
with a normative reference which partly fulfils the requirements laid down in a technical regulation, 
compliance with the technical regulation's remaining requirements shall be proved using any of the 
methods provided in this Chapter. In any even t, the products may not be marketed or made 
available to third parties under any circumstances until the certificate proving full compliance with 
the technical regulation has been issued by a comp etent body in accordance with the provisions in 
this Chapter. 
After the conformity certificate has been obtained, the importer shall attach it to the import licence 
or registration when submitting it to the Single Window for Foreign Trade – VUCE. (…) 
1.9  SECTION 11: SCIENTIFIC AN D INDUSTRIAL METROLOGY 
ARTICLE 2.2.1.7.11.1 National authority fo r scientific and industrial metrology 
National Institute of Metrology – INM shall be the authority responsible for coordinating the 
conduct of scientific and industrial metrology at the national level, in accordance with the 
provisions in Decree No. 4175 of 2011. G/TBT/2/Add.18/Rev.1/Suppl.2 
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  The National Institute of Metrology shall provide laboratories, research centres and industry with 
reference materials, proficiency testing/inter-laboratory comparison and calibration with measurement standards if these cannot be provided by accredited laboratories or service suppliers 
composing the network. (…) 
ARTICLE 2.2.1.7.11.6 Dissemination and disc losure of the International System of 
Units – SI 
The National Institute of Metrology – INM shall be responsible for disseminating metrological 
traceability to the International System of Units – SI and for its disclosure, meaning the base and 
derived units defined by the General Conference on Weights and Measures. 
In order to ensure the disclosure and disseminati on of the International System of Units, the 
National Institute of Metrology – INM shall determine with the competent authority the 
mechanisms needed to facilitate import and export procedures for measurement standards, 
artefacts, measuring instruments, specimens, reference material and inputs for production, for its exclusive use. 
Paragraph. After hearing the opinion of the Nation al Institute of Metrology – INM, the Supervisory 
Authority for Industry and Trade shall determine the use of customary measuring units that do not form part of the International System of Units – SI, which shall be expressed in units of 
measurement of both systems. (…) 
ARTICLE 2.2.1.7.12.6 Legal time in the Republic of Colombia In accordance with the indications in paragraph 14 of Article 6 of Decree No. 4175 of 2011, the 
National Institute of Metrology – INM shall be responsible, inter alia , for maintaining, coordinating 
and disseminating legal time in the Republic of Colombia. Accordingly, companies, entities or 
organizations whose services communicate or make use of it in any way shall utilize the legal time coordinated by the INM. (…) 
1.10  SECTION 14: LEGAL METROLOGY 
ARTICLE 2.2.1.7.14.1 Metrological control authorities 
The Supervisory Authority for Industry and Trade shall have competence for drawing up and 
issuing metrological technical regulations for measuring instruments subject to metrological 
control. 
The Supervisory Authority for Industry and Tr ade and municipal authorities shall exercise 
metrological control directly or with the support of authorized metrological verification bodies 
and/or conformity assessment bodies in the territory under their jurisdiction. Likewise, when the 
Supervisory Authority for Industry and Trade decides to carry out metrological control campaigns in certain regions of the country, it shall coordinate with local authorities the controls and 
inspections deemed necessary. 
The Supervisory Authority for Industry and Trade may also utilize the technological and informatics 
tools it deems necessary in order to ensure appropriate metrological control and shall determine 
the manner in which producers, importers, repairers and those responsible for measuring 
instruments shall forward information to the system. 
Monitoring by the Supervisory Authority for Industry and Trade in relation to metrological control 
shall also cover those in possession of measuring instruments, repairers, authorized metrological 
control bodies and conformity assessment bodies. (…) 
ARTICLE 2.2.1.7.14.3  Measuring instruments subject to metrological control 
Measuring instruments used for measuring, weighing or counting and having the following as their 
purpose, inter alia, shall be subject to compliance with the provisions in this Chapter: 
1. Engaging in trade transactions or determining the price of services. 
2. Remunerating or calculating professional work in any way. 
3. Providing public at-home services. 
4. Engaging in activities that may affect life, health or physical integrity, national security or 
the environment. 
5. Providing expertise, carrying out judicial or administrative acts. 
6. Assessing the conformity of products and facilities. G/TBT/2/Add.18/Rev.1/Suppl.2 
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  7. Determining the quantity of components of a product whose price or quality depends on 
those components. (…) 
ARTICLE 2.2.1.7.15.6 Obligation to register Pursuant to the provisions in Article 17 of Law No. 1480 of 2011, prior to introducing or importing 
products subject to a technical regulation, any producer or importer shall register with the Register 
of Producers and Importers of products subjec t to compliance with technical regulations, 
established by the competent authority for this purpose. 
1.11   SECTION 16: VOLUNTARY CONFORMITY ASSESSMENT 
ARTICLE 2.2.1.7.16.1 Volunt ary conformity assessment 
Conformity certification within the National Quality Subsystem may be obtained for goods and 
services not subject to technical regulations. 
ARTICLE 2.2.1.7.16.2 Quality of transactions 
Compliance with technical standards and the use of conformity certificates issued by the accredited 
bodies referred to in this Chap ter may be required for commercial or administrative transactions. 
1.12  SECTION 17: SUPERVISION AND CONTROL 
ARTICLE 2.2.1.7.17.1 Powers of the Superv isory Authority for Industry and Trade 
The Supervisory Authority for Industry and Trade shall undertake the relevant administrative 
investigations into conformity assessment bodies in respect of compliance with requirements 
applicable to the conformity certificates or conf ormity assessment documents they have issued in 
connection with government procurement-related technical regulations or technical standards. 
The Supervisory Authority for Industry and Trade sh all also undertake the relevant administrative 
investigations into metrological control bodies; authorized repairers which fail to comply with the 
responsibilities incumbent upon their function; pr oducers, importers, dealers and those responsible 
for measuring products or instruments, for failure to comply with their obligations laid down in this 
Chapter or in the relevant technical regulations. 
The foregoing in accordance with the provisio ns in Articles 73 and 74 of Law No. 1480 of 2011. 
The Supervisory Authority for Trade and Industry, in exercise of the powers conferred by 
Law No. 1480 of 2011, may undertake investigations into persons which, when importing or 
marketing products subject to government procurement-related technical regulations or technical standards, submit conformity certificates, declaratio ns of conformity or results of laboratory tests 
in respect of which there is a suspicion of deception or adulteration and, as a result of such 
investigations, may impose the sanctions provided in Article 61 of Law No. 1480 of 2011. The 
foregoing without prejudice to the co rresponding criminal proceedings. (…) 
ARTICLE 2.2.1.7.17.5 Creation of the Conformity Certificates Information System - 
SICERCO 
The Conformity Certificates Information System - SICERCO is hereby created, to be administered 
by the Supervisory Authority for Industry and Trade, in which certification and inspection bodies 
accredited by the National Accreditation Organization  shall register electronically all the conformity 
certificates they issue for products subject to compliance with technical regulations. The Supervisory Authority for Industry and Trade sh all be responsible for regulating the System. 
The Conformity Certificates Information System  – SICERCO is a public register and may be 
consulted on the website of the Supervisory Authority for Industry and Trade. 
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