3.165.  Chile has a relatively extensive legal and regulatory framework regarding the sanitary and phytosanitary system, and the preparation and application of sanitary and phytosanitary (SPS) measures is the responsibility of a number of authorities. Chilean regulations on food safety and animal and plant health are summarized in Box 3.1. Source: Information provided by the authorities

3.166.  The main institutions in charge of drafting and applying SPS measures are still the Ministries of Agriculture (through the Agriculture and Livestock Service (SAG)); Health (through the Under-Secretariat of Public Health) and the Economy (through the Under-Secretariat of Fisheries (SUBPESCA) and the National Fisheries and Aquaculture Service (SERNAPESCA)). Each of these bodies is responsible for drafting and applying the SPS measures within their sphere of competence both as regards the domestic market and imports and exports. The Under-Secretariat for International Economic Relations (SUBREI) of the Ministry of Foreign Affairs heads the Ministerial Committee on Sanitary and Phytosanitary Matters

3.167.  SAG is the national service that acts as the national notification authority and enquiry point for the purposes of the WTO SPS Agreement. The drafting and notification process for SPS measures is governed by the "Recommended procedures for implementing the transparency obligations of the SPS Agreement" (G/SPS/7/Rev.5)

3.168.  The authorities noted that SAG, in its role as national notification authority for the purposes of the SPS Agreement, has developed additional tools for national application to strengthen the application of the principle of transparency, one of which is the "Guide to Good Practices for National Notification Authorities of the Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures of the World Trade Organization (WTO)", published in November 2020.[255]

3.169.  The Ministry of Health, through the Food Health Regulations, regulates the production, import, processing, packaging, storage, distribution and sale of food for human consumption. Food must undergo sanitary controls and laboratory analysis based on risk criteria related to the nature of the food, the form of distribution, and the type of processing and packaging involved. These controls are carried out by the Regional Secretariats of the Ministry of Health (SEREMIs). The competent authority for animal health for hydrobiological species and the safety of foods of aquatic origin is the National Fisheries and Aquaculture Service (SERNAPESCA), which is responsible for verifying compliance with fishing and aquaculture regulations and conducting sanitary management. SERNAPESCA develops Aquaculture Health Programmes, in accordance with the provisions of the Aquaculture Health Regulations

3.170.  The process of drafting an SPS measure begins when the need to update an existing measure is identified or when a sanitary event occurs that requires a new regulation. The procedure for drafting and notifying SPS measures is governed by the "Recommended procedures for implementing the transparency obligations of the SPS Agreement". Draft SPS measures are drawn up by technical committees and are based, in general, on the international regulations of the International Plant Protection Convention (IPPC), the World Organisation for Animal Health (WOAH) and the Codex Alimentarius, all organizations to which Chile belongs

3.171.  Regarding SAG's regulatory procedure, a new resolution proposal or amendment to an existing resolution can be initiated upon the request of the affected sectors or when issues have been identified by the relevant SAG Division. Once the issue has been identified and a regulatory solution formulated, the necessary internal consultations take place, the comments resulting therefrom are processed and the resolution is drafted. If the resolution involves a new origin or a new species of plant or plant product, a pest risk analysis needs to be conducted to establish the phytosanitary measures required. For animal health, the WOAH standards are followed. The revised resolution proposal is sent for review by the Legal Division, specifically the Regulatory Department, where the legal and technical coherence and consistency of the draft is evaluated. Where there is a need for clarification, technical meetings are coordinated in order to clarify terms, actions and anything else required. After the draft has been agreed, it is returned with the approval of the Legal Division to proceed to public consultations and notification under the SPS Agreement. The consultation period is 60 days, unless requests are made to extend this period, or if the measure is being introduced in the event of an emergency or in order to facilitate trade. Comments are taken into account after being analysed and depending on their basis. Once they have been received and processed, the resolution is revised again and undergoes another legal review before becoming the final version that will be signed by the National Directorate of the service

3.172.  Once the resolution is signed, it is sent to the Official Journal for publication and is incorporated into the Regulatory Library, making it available to all users. SPS measures are enacted by means of a decree, resolution or other pertinent legal instrument issued by the competent institution. These instruments are available on the website of the relevant institution.[256]

3.173.  Between 2015 and 2022, SAG established 310 SPS measures related to the entry of different products and merchandise into Chilean territory. Of these measures, around 80% correspond to regulations on plant health and the remaining 20% to animal health. Forty eight % of these measures amend previous regulations, while 19% repeal old regulations, replacing them with updated ones. The authorities are of the view that the implementation of international standards by SAG, including the conduct of a risk assessment to ensure compliance with international agreements, has contributed to protecting animal and plant health, and has facilitated international trade

3.174.  Between January 2015 and March 2023, Chile submitted 444 notifications to the WTO's SPS Committee, including addenda and corrections (233 new regular notifications, 157 addenda to regular notifications, 12 corrections, 14 revisions, 18 notifications of emergency measures, 9 addenda and a revision to notifications of emergency measures). During the review period, no WTO Member filed new complaints against Chile in the SPS Committee.[257]

3.175.  Most of the SPS measures notified to the WTO during the 2015–22 period were based on international standards. If a risk assessment reveals the need for more stringent regulations than the international ones, the regulations are drafted internally

3.176.  SAG defines the general and specific animal and plant health requirements to be met when importing livestock or plant products into Chile. The import of animal and plant products into Chile requires an animal or plant health certificate issued by the competent health authority of the country of origin.[258] In addition, the import and transit of animals, and livestock and plant products must occur through ports authorized by SAG, with verification of compliance with animal and plant health regulations.[259] Furthermore, imports of plants and plant products must comply with SAG's phytosanitary requirements, which are contained in specific regulations published in the Official Journal in the form of resolutions. Any natural or legal person can request an import authorization. To obtain an import authorization for a regulated article or dangerous goods of material subject to a post‑entry quarantine regime, the specific regulations and procedures for this type of material must be followed. The phytosanitary requirements and entry conditions for a regulated article or goods dangerous to plants can be consulted on the SAG website or at SAG's regional directorates or offices in each region of the country. Where importing regulated articles or goods dangerous to plants for which no phytosanitary requirements are published in the Official Journal, an application for authorization to import regulated articles must be submitted to the corresponding SAG office. There, an assessment of the phytosanitary requirements for product entry can be initiated through a pest risk analysis (PRA).[260] In addition, depending on the risk, SAG determines whether the import can be authorized and establishes the phytosanitary requirements, which must be submitted for public consultation nationally, notified to the WTO and finally published in the Official Journal

3.177.  The Regional Secretariats of the Ministry of Health (SEREMIs) determine whether imported food is suitable for human consumption. This is done through in‑person or document‑based sanitary inspection, according to the risk criteria involved and the history of compliance with the regulation recorded for previous imports. This process is carried out for all food items through the health authority's digital platform. The criteria are set out in the Exempt Resolution establishing the "Manual on the Importation of Food Destined for Human Consumption".[261] With regard to exports, the SEREMIs issue certificates of free sale (CLV), which certify that the foods declared by the exporters or their representatives are authorized for use, consumption and marketing in Chile. To request a CLV, one must have sanitary authorization from the food facility and this document must be authenticated by the Ministry of Foreign Affairs

3.178.  Importers must ensure that they have the necessary certification in accordance with the established requirements. Such certification is verified through documentary and physical inspection at the border via the Import System. Some goods, such as live animals and plants (including seeds), are required to enter post‑entry quarantine (PEQ) before their definitive release to the national market. All imported animals, regardless of their origin, must enter PEQ once approval has been given during the documentary and physical inspection at the border entry control. During quarantine, the health status of the animals is verified and species‑specific inspection and diagnostic tests are carried out. In the case of plants and vegetables, phytosanitary assessments are carried out at the time of importation to check for the presence of pests. Plants and seeds undergo PEQ depending on the phytosanitary status of their country of origin and on the basis of a phytosanitary risk analysis (see below) based on IPPC guidelines. Plant materials that must enter PEQ are plants or parts thereof intended for planting or grafting

3.179.  Exempt Resolution No. 3.815/2003, as amended by Exempt Resolutions No. 2.781/2006 and No. 1.634/2016, establishes rules for the importation of regulated articles or goods dangerous to plants, which are classified according to their phytosanitary risk in the categories 0, 1, 2, 3, 4 and 5. Regulated articles require an import authorization and must comply with the phytosanitary and/or biosafety requirements for entry into the country, as well as with the entry conditions established in specific resolutions. Regulated articles must be packed in new, first‑use containers, and each import unit must include information about the country of origin, name or code of the producer, plant species and other conditions required by the specific resolution

3.180.  Exempt Resolution No. 1.284/2021 of the Ministry of Agriculture establishes the categorization of plant products according to their pest risk, considering the method and extent of processing applied and their intended use. That includes goods entering the country for use as animal feed.[262] Products are sorted into four categories: (a) category 1 covers processed products that are no longer susceptible to infestation by quarantine pests and therefore do not require phytosanitary measures or certification; (b) category 2 covers products that although processed, may still be infested by some quarantine pests (in this case, according to the method and extent of processing, the intended use of the product and the result of the inspections of imported goods, SAG may establish the phytosanitary certification requirement for certain processes or goods); (c) category 3 covers products that have not been processed, that have the potential to introduce or spread quarantine pests, and whose intended use is for a purpose other than propagation, such as consumption or processing (in these cases, a pest risk analysis is necessary. Products in this category include fresh fruits, fresh vegetables, fresh cut flowers and branches, stems for consumption, and roots, rhizomes, tubers, bulbs and corms); and (d) category 4 covers products that have not been processed, that have a higher possibility of introducing or spreading regulated pests and whose intended use is propagation (in this case a pest risk analysis is also necessary. This category includes: cuttings, stakes, roots, rhizomes, tubers and bulbs; micropropagated material; plants; in vitro plants; pollen; branches and twigs; seeds; stems; and other plant material for propagation).[263]

3.181.  In accordance with SAG Exempt Resolution No. 1.284/2021, products in categories 2, 3 and 4 and products in category 1 destined for animal consumption and that require livestock approval, or organic products destined for human or animal consumption, must be presented to SAG at the authorized point of entry for the respective import procedure to be carried out. SAG uses pest risk analysis to determine the risk of regulated pests and to establish phytosanitary measures for products classified in categories 2, 3 and 4. The products classified in the aforementioned categories must arrive in Chile with a phytosanitary export or re‑export certificate issued by the corresponding phytosanitary authority of the country of origin or provenance. These products must comply with the phytosanitary requirements established by SAG in current regulations and specific resolutions. Any other regulated article not considered in the previous categories, the importation of which carries a phytosanitary risk of introduction and establishment of a regulated pest, must arrive in the country already in compliance with the phytosanitary requirements established by SAG in specific resolutions.[264]

3.119.  During the period under review, there were no major changes to Chile's legal and institutional framework for the preparation and application of technical regulations, standards and conformity assessment procedures. As stated in the previous report, the development of technical regulations and standards in Chile is based on the principles of non‑discrimination and transparency and on the use of international standards. Furthermore, pursuant to the Transparency Law in force since 2008, Chile is required to publish through the websites of its regulatory agencies all technical regulations and conformity assessment procedures in force. Chile also has a Technical Regulations Gateway, which is intended to centralize this information by making it easier for potential new exporters to find information on access to its market. During the period under review, Chile prepared and notified a large number of technical regulations

3.120.  Chile's legislation on technical regulations includes: the WTO Agreement on Technical Barriers to Trade (TBT Agreement), which came into force in Chile in May 1995 pursuant to Supreme Decree No. 16 of 1995 issued by the Ministry of Foreign Affairs[227]; Law No. 19.912 of 2003[228] creating a mechanism for compliance with the notification commitments under the TBT Agreement; Decree No. 77 of 2004 of the Ministry of the Economy[229] laying down the requirements to be met by competent institutions when preparing, adopting and applying technical regulations and conformity assessment procedures; Decree No. 308 of 2008[230] amending Decree No. 77; and the series of regional trade agreements that Chile has signed, most of which contain a chapter on technical regulations, standards and conformity assessment procedures

3.121.  Decree No. 77 of the Ministry of Economy, entitled "Regulations for the Implementation of Title I of Law No. 19.912 and Requirements for the Preparation, Adoption and Application of Technical Regulations and Conformity Assessment Procedures", contains the primary regulations for the preparation of technical regulations and conformity assessment procedures for all government agencies. The Decree specifies that the Regulations shall apply to the preparation, adoption and application of technical regulations and conformity assessment procedures, consistent with the provisions of the TBT Agreement.[231] The Regulations apply on a suppletive basis in cases where other laws establish special procedures

3.122.  Decree No. 316 of 7 July 2023 approves the Regulations for Article 28(11) of Law No. 21.080 of 7 March 2022.[232] This Decree concerns the notification of technical regulations and conformity assessment procedures to the WTO and other resulting obligations. The main objective of the Decree is to establish the basis for the preparation of technical regulations and conformity assessment procedures in all government agencies. The Decree specifies that the Regulations shall apply to the preparation, adoption and application of technical regulations and conformity assessment procedures, consistent with the provisions of the TBT Agreement. The Regulations apply on a suppletive basis in cases where other laws establish special procedures

3.123.  The Regulatory Affairs Division of the Under‑Secretariat for International Economic Relations (SUBREI), within the Ministry of Foreign Affairs, is responsible for administering the TBT Agreement, acting as the enquiry point for matters relating to technical regulations and conformity assessment procedures. It also serves as the official point of contact on TBT matters, notifies the WTO and chairs the National Commission on Technical Barriers to Trade, which aims to implement the obligations of the TBT Agreement and coordinate Chile's position in trade negotiations in this area among the participating entities

3.124.  The National Commission on Technical Barriers to Trade (CNTOC), constituted ex officio and originally chaired by the Ministry of Economy, through the Department of Foreign Trade (DECOEX), is currently chaired by SUBREI, through the Regulatory Affairs Division.[233] The CNTOC is composed of public institutions related to the drafting, adoption and implementation of standards, technical regulations and conformity assessment procedures, including the Under‑Secretariat of Transport, the Under‑Secretariat of Telecommunications, the General Directorate of Public Works (MOP), the Ministry of Housing and Urban Development (MINVU), the Ministry of the Environment (MMA), the Agriculture and Livestock Service (SAG), the Electricity and Fuels Supervisory Authority (SEC), the National Fisheries Service (SERNAPESCA), the Ministry of Health (MINSAL), the Public Health Institute (ISP), the National Consumer Service (SERNAC), the National Standardization Institute (INN), the Sanitary Services Supervisory Authority (SISS), the Ministry of Mining, the Under‑Secretariat of Fisheries (SUBPESCA), the Ministry of Defence, the Ministry of Energy, the Office of Agrarian Studies and Policies (ODEPA), the Office of the Secretary‑General of the Office of the President (SEGPRES), the Chilean Food Quality and Safety Agency (ACHIPIA) and the National Energy Commission (CNE)

3.125.  The purpose of the CNTOC is to ensure compliance with obligations under the TBT Agreement, coordinate Chile's position in the relevant trade negotiations and promote standardization as a tool in support of Chile's technological modernization process, among other tasks. It meets three times a year, prior to the quarterly meeting of the TBT Committee in Geneva.[234]

3.126.  Chile is a member of various international standardization, accreditation and metrology bodies. For standardization: the International Organization for Standardization (ISO), the Pan American Standards Commission (COPANT) and the Codex Alimentarius; Chile participates as a non‑voting associate member of the MERCOSUR Standardization Association (AMN). For accreditation: the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC) and the Inter‑American Accreditation Cooperation (IAAC). For metrology: the International Bureau of Weights and Measures (BIPM) and the Inter‑American Metrology System (SIM)

3.127.  The preparation, adoption and application of technical regulations shall be the responsibility of the respective ministries or agencies that are so authorized.[235] Technical regulations should be based, as far as possible, on national or international standards, should not create unnecessary obstacles to trade, and should be based on performance criteria, that is, they should be defined in terms of the products' performance rather than design or descriptive characteristics. Technical regulations are issued at central government level in the form of laws, decrees or resolutions

3.128.  Technical regulations are prepared, adopted and applied such that imported products are accorded treatment no less favourable than that accorded to like products of national origin and to like products originating in any other country. Likewise, conformity assessment procedures are prepared, adopted, and applied so as to grant access for suppliers of like products originating in another country under conditions no less favourable than those accorded to suppliers of like products of national origin or originating in any other country, in a comparable situation

3.129.  The preparation, adoption and application of technical regulations and/or conformity assessment procedures shall follow the following steps: (a) the Ministry or agency with regulatory authority shall publish, by means of a notice in the national media or on its website, the proposed technical regulation or conformity assessment procedure; (b) the notice shall include, at a minimum, an extract from the draft technical regulation or conformity assessment procedure and a link to its full text; (c) a report shall be included explaining the objective of the planned measure and the existence of applicable international standards on the subject; (d) the notice shall be published far enough in advance of the date of adoption of the measure to allow written comments to be made for at least 60 days, which must be analysed and taken into account; and (e) the technical regulations and/or conformity assessment procedures shall provide for a reasonable period of not less than six months between the date of their adoption and their application. The above steps may be omitted in cases where urgent problems of safety, health, environmental protection or national security arise or threaten to arise

3.130.  The Agriculture and Livestock Service (SAG) is one of the entities responsible for providing technical support in the preparation of certain technical regulations, such as those governing organic products, veterinary medicines, animal feed, animal welfare and meat grading. SAG is directly responsible for the regulation of products such as pesticides, fertilizers and seeds

3.131.  Decree No. 77 of 2004 and its amendment (Decree No. 308 of 2010) provide that the Ministry of Economy shall notify draft regulations and/or conformity assessment procedures to the WTO and receive comments from other WTO Members. Such drafts may only be issued at least 60 days after their notification. Technical regulations and/or conformity assessment procedures shall include: (a) identification of the product, including its classification according to the Harmonized Commodity Description and Coding System (HS) and the objective of the measure; (b) the specifications and characteristics of the product; (c) conformity assessment methods; (d) the data and other information to be displayed on the products or else on their containers or packaging and their marking requirements; (e) the degree of consistency with international standards and guidelines used as a basis in their preparation; (f) mention of the institution or institutions responsible for enforcing the regulations; and (g) any other information necessary for the proper understanding of the regulations or procedure including their scope

3.132.  After approval, technical regulations and conformity assessment procedures are published in the Official Journal and on the website of the respective regulatory agencies, since, according to the Transparency Law, each regulatory agency must publish its technical regulations and conformity assessment procedures in force. In general, there is no single procedure for the review of technical regulations, as this depends on each agency and its needs. Nevertheless, it is customary practice for the competent agencies to review technical regulations and conformity assessment procedures regularly to amend or repeal them, as appropriate. For example, technical regulations for electrical and fuel products are reviewed by the Electricity and Fuels Supervisory Authority (SEC) every year and, according to information provided by the authorities, at least 15 regulations are updated or produced every year. The procedure for modifying technical regulations is the same as for their preparation. However, in the case of the SAG, there is no explicit and systematic procedure for ex post review; instead, there are review and adjustment processes triggered upon request or detection of application difficulties, save where the relevant legal body has established a specific period. All domestic and imported goods must comply with the corresponding technical regulations

3.133.  Between January 2015 and early March 2023, Chile submitted 535 notifications to the WTO Committee on Technical Barriers to Trade, of which 328 were new notifications and the remainder were addenda or corrigenda.[236] Of the 328 notifications of new measures, 183 were related to technical regulations, 4 to urgent technical regulations, 1 to local government technical regulations and 136 to conformity assessment procedures. Five of these notifications involved both technical regulations and conformity assessment procedures. The objective of the majority of the technical regulations notified (101) was protection of human health or safety, and they mainly concerned foodstuffs, household appliances, building materials, vehicles, toys, pharmaceutical products and cosmetics, among others. The remaining objectives include quality requirements (47); environmental protection (46); labelling (27); prevention of deceptive practices (16); protection of plant or animal life or health (10); and others (9). The government authorities involved in preparing the measures notified included the Ministries of Health, Economic Affairs, Housing and Urban Planning, Transport and Telecommunications, and the Environment

3.134.  During the period under review, Members raised six new trade concerns regarding Chilean technical regulations in the TBT Committee, relating to the efficiency analysis and/or test protocol for electrical products (ID 704) (Republic of Korea); amendment to the general regulation of the compulsory system for livestock classification and the grading, marking and marketing of Beef (ID 693) (Brazil); technical specifications for the design of energy efficiency labels for washing machines (ID 654) (Republic of Korea); regulations on the classification, labelling and notification of chemical substances and mixtures (ID 570) (Mexico); public consultation for draft legislation setting out rules on the preparation, description and labelling of milk products deriving from milk (ID 566) (European Union; New Zealand; Russian Federation; and United States); and proposed amendment to the Food Health Regulations, Supreme Decree No. 977/96 (ID 370) (Argentina; Australia; Brazil; Canada; Colombia; Costa Rica; European Union; Guatemala; Mexico; Peru; Switzerland; and United States).[237]

3.135.  Standardization is the responsibility of the National Standardization Institute (INN), a non‑profit, private law foundation, set up by the Economic Development Agency (CORFO) as a technical body in matters of quality infrastructure. The INN is responsible for developing and disseminating the use of voluntary Chilean technical standards (NCh); coordinating the National Metrology Network; and accrediting conformity assessment bodies. It is also tasked with helping to ascertain the need for new standards. Its mission is to be the national reference point in matters of quality, leading a process that results in the adoption of best practices in this field.[238]

3.136.  The INN develops technical standards for the different productive sectors through various funding schemes, and provides an online service to access technical documents, both NCh and international standards. It also carries out accreditation work for system certification bodies, product certification bodies, personal certification bodies, testing laboratories, calibration laboratories, clinical laboratories, inspection bodies, verification bodies and proficiency testing providers. The INN administers and coordinates the National Metrology Network, composed of various public and private laboratories in the international fields of physics and chemistry

3.137.  The INN represents Chile in the International Organization for Standardization (ISO), the Pan American Standards Commission (COPANT) and is an invited member of the MERCOSUR Standardization Association. In the field of accreditation, the Institute is a founding member of the Inter‑American Accreditation Cooperation (IAAC) and, since 2010, is a signatory member of the IAAC's Multilateral Recognition Agreements (MLA/MRA) for the accreditation of: certification bodies for quality management systems (ISO 9001), certification bodies for environmental management systems (ISO 14001), testing laboratories, clinical laboratories and calibration laboratories. Since 2016, the INN also has MLAs for the accreditation of product certification bodies and inspection bodies. The INN is also a full member of the International Laboratory Accreditation Cooperation (ILAC) and, since 2010, is a signatory to the ILAC Mutual Recognition Arrangements (MRA), covering the accreditation of testing laboratories, clinical laboratories and calibration laboratories and, since 2016, the accreditation of inspection bodies. The INN is similarly a full member of the International Accreditation Forum (IAF) and a signatory member of the IAF's MLA for the accreditation of quality management systems certification bodies (ISO 9001) and environmental management systems certification bodies (ISO 14001) and, since 2016, the accreditation of inspection bodies

3.138.  In the field of metrology, the INN represents Chile at meetings of the General Conference on Weights and Measures (CGPM) and the International Bureau of Weights and Measures (BIPM). In 2000, the INN signed the MLA of the International Committee of Weights and Measures (CIPM‑MRA), which allows test and calibration certificates issued by the National Metrology Network to be recognized internationally. Since 1995, the INN has been part of the Inter‑American Metrology System (SIM).[239]

3.139.  The internal procedures for the drafting of Chilean Standards are specified in the Standardization Service Regulations, following the criteria internationally accepted by the ISO and the International Electrotechnical Commission (IEC).[240] The INN Council, sitting on 24 June 2019, approved new Standardization Service Regulations that establish the processes and requirements that apply to the production of normative documents, whether Chilean Standards or Technical Publications, drafted by the INN and stemming from a standardization service. From the date of approval of the new Regulations, the INN abrogated the following Chilean Standards: NCh1:2011 Chilean Standards (NCh) – Definitions and procedure for their consideration and maintenance, and NCh2851:2012 Technical Publications – Definitions and procedure for their consideration and revision, since the contents of these are dealt with in the new Standardization Service Regulations and in the Internal Procedures of the Standards Division

3.140.  The standardization process is initiated at the request of a person or public or private entity. Natural or legal persons wishing to make use of the standardization service may make a request using the Standardization Service Request Form available on the INN website, or in person or virtually to receive technical assistance to complete the form. The INN Standards Division submits this information to the Standards Committee for its opinion. The Standards Committee is empowered to approve the standardization service request, reject it or request further information from the Standards Division and/or the client, as appropriate. If the Standards Committee agrees to study a standards document, it must indicate the type of standard to be prepared and the process to be used, sending the applicant a quotation for the type of service to be provided; once approved by the client, the draft contract will be sent to the client for signature. Once both parties have signed the contract, the standardization process can begin

3.141.  The procedure for developing a standard starts with a draft standard, which may be drawn up by the INN or by an external organization. The draft may be produced on the basis of international, regional or foreign standards, or from national precedents. The INN may determine that the draft should be submitted to a Draft Committee or move directly to the public consultation stage, which is announced on the INN website, indicating the identification code, the title of the draft standard and the consultation closing date

3.142.  The INN may invite those organizations and individuals with an interest in the subject under consideration to participate in the public consultation. The public consultation period for a draft standard is set by the Standards Committee, taking into account, among other factors, whether the draft standard is a revision, or whether there are reasons of safety, health or risk of environmental damage. At the end of the public consultation period, if the draft standard has received no comments, it may be submitted to the Executive Director of the INN, thereby ending the standardization service. If comments are made on the draft standard under public consultation, the Standards Division will set up a technical committee open to the participation of interested parties and led by a technical secretary appointed by the INN. Once the analysis of the comments has been completed, the final version is prepared and submitted for approval by the members of the technical committee, which must be by consensus, and for validation by the INN's Standards Division. Based on this version, the final draft of the standard is prepared and submitted to the Executive Director of the INN, thus completing the standardization service contracted

3.143.  Chilean Standards are updated and reviewed when a need is detected by a public or private third party and is financed by that party. Internal requests may also be triggered by the needs of the INN. The procedure for updating standards is the same as drafting procedure described above

3.144.  The INN keeps a catalogue of Chilean standards and gathers information on standards under consideration, which can be viewed on its website.[241] As at 30 June 2023, there were 4,301 Chilean Standards

3.145.  The preparation and application of conformity assessment procedures defined by the competent regulatory authority follow the same stages and time limits as technical regulations. In general, each technical regulation includes its conformity assessment process. The regulation defines the requirements to be fulfilled by the conformity assessment bodies involved. According to the authorities, for both imported and domestic products, compliance with technical regulations is, for the most part, verified after the products have been placed on the market. Only in case of imports of certain products, mostly foodstuffs, beverages, medicines, weapons, radioactive substances, electrical goods and fuels, does verification take place at the border

3.146.  In most cases, conformity assessment is the responsibility of bodies accredited by the INN, although in some cases, the ministry or government authority that issued the technical regulation carries out the verification using its own facilities. The government authorities which recognize INN accreditation include SAG, the Ministries of the Economy, Health, Housing and Urban Planning, Labour and Social Security, and Women and Gender Equity, the Public Health Institute (ISP), Sanitary Services Supervisory Authority (SISS), the National Customs Service, the National Training and Employment Service (SENCE), the Under‑Secretariat of Fisheries and Aquaculture (SUBPESCA), the National Fisheries Service (SERNAPESCA), the National Tourism Service (SERNATUR) and the Electricity and Fuels Supervisory Authority (SEC). A declaration of conformity from the supplier is not acceptable

3.147.  All goods which, in accordance with the legislation in force, must be subject to checks prior to importation by a state body must be certified upon entry into Chile. A list of these goods is set out in Table 3.1. Among the products requiring pre‑market certification are electrical products, cosmetics and hygiene products. In the case of electrical products and products that use fuels, the SEC is responsible for establishing, maintaining and enforcing the mandatory certification system, by drawing up the specific protocols that domestic and international electrical products and fuel‑related equipment marketed in the country must follow for their proper safety and energy efficiency performance, and authorizing certification bodies and testing laboratories. The certification of these products is governed by the Regulation for the Certification of Electrical Products and Fuel‑Related Equipment, which establishes the procedures for the safety and quality certification of electrical products.[242] Each product has its own protocol pursuant to Article 6 of the Regulation, which states that whatever the origin of the products, they must be certified prior to being commercialized in the country, through one of the certification systems indicated in Article 5 of the Regulation[243], in accordance with the testing protocols established by the Supervisory Authority

3.148.  Chapter VII of Decree No. 298 of 10 November 2005 deals with the recognition of foreign certificates. According to Article 21, persons interested in marketing products with certificates issued abroad may opt for the Special Certification System, for which, among other requirements, they must provide a document issued by an accreditation body certifying that the certification body issuing the certificates is properly empowered to certify the products, and a copy of the foreign standard or technical specification used for the certification of each particular product. In addition, the accreditation body must be a signatory to the multilateral recognition agreement of the International Accreditation Forum (IAF). Once the background information has been evaluated and it has been determined that the standards or technical specifications submitted comply with those established in the national protocols, the SEC will issue a resolution specifying the body issuing the foreign certificates, the list of products authorized for certification and the technical standards or specifications applicable to each product. This resolution is an essential requirement for the subsequent issuance of the certificate establishing the conformity of the batch by the certification body

3.149.  The SEC website contains the list of electrical products and fuel‑related equipment subject to certification, certification bodies and authorized testing laboratories. The products subject to mandatory certification are those determined by the Ministry of Energy by means of a resolution, as suggested by the SEC.[244] Electrical products subject to compulsory certification include appliances, apparatuses, accessories, equipment, instruments, devices, materials or machinery that use, store or transport electrical energy or are electrical insulators, or parts thereof. In the case of fuel‑related equipment, this generally concerns apparatuses, fittings, cylinders, devices, tanks, materials, equipment, instruments and piping, which are used to release energy or to store, transport, dispense and measure liquid or gaseous fuels, or parts thereof. The certification requirements apply to both manufacturers and importers and/or traders, who must obtain a certificate of approval for their product, irrespective of its origin, from a certification body authorized by the SEC. If this certification is obtained, these products receive the SEC Seal, which identifies those products that comply with current Chilean regulations and minimum safety standards

3.150.  Pharmaceutical products and cosmetics, whether imported or manufactured in Chile, must have a sanitary authorization from the Ministry of Health and be registered with the Institute of Public Health prior to their commercialization. Authorization is subject to compliance with the health regulations approved by the Ministry of Health. The registration application form is available on the Institute's website. The regulations on pharmaceutical products are set forth in Decree No. 3 of 2011 of the Under‑Secretariat of Public Health.[245] The regulations governing cosmetics are contained in Decree No. 239 of 2002 of the Ministry of Health.[246]

3.151.  Labelling, classification and packaging requirements also apply. For example, pursuant to Supreme Decree No. 977/96 of the Ministry of Health, approving the food health regulations, all packaged or canned foods imported into Chile must display labels in Spanish and specify, inter alia, all ingredients and additives, dates of manufacture and expiry, together with the name of the country of manufacture and the importer's details. The labels must also include the nutritional value of all packaged foods and beverages per 100g/ml and per serving typically consumed for both domestic and imported products, as well as a black octagonal symbol with a white border and the words "HIGH IN", where appropriate.[247]

3.152.  SAG is responsible for establishing the rules and procedures for the importation and release, under confined conditions, of genetically modified (GM) vegetative propagating material imported or developed in Chile. The confined sowing of an imported or domestically‑developed genetically modified organisms (GMO) is allowed with prior authorization from SAG, following a case‑by‑case risk analysis process, depending on the species and the genetic modification incorporated, and the establishment of biosafety measures. The only activities that SAG permits are growing seedlings for export purposes and carrying out evaluation trials. SAG inspects and oversees all GMO seedbeds and trials in the country, for the entire crop cycle, in order to verify compliance with the biosafety measures established for each species so as to be able to guarantee their complete traceability

3.153.  Law No. 20.656 of 28 January 2013, which regulates commercial transactions in agricultural products, establishes mechanisms and instruments to regulate the procedures that determine the quantity and quality of products traded in the agricultural market.[248] This Law sets forth a mandatory procedure for the analysis of samples and counter‑samples, and measurement, as appropriate, of agricultural products traded in the domestic market and not regulated by a special law. It provides for specific regulations to be issued by the Ministry of Agriculture, determining the agricultural products that will be subject to the procedure established by law and laying down the methodologies for the measurement of the quantity, mass or volume of the products, as well as for taking, collecting, handling, preserving, transporting and the custody of samples and counter‑samples and the analysis of their characteristics. Regulations are currently in force for maize, wheat, wine grapes and oats. The analysis is conducted in SAG laboratories.[249]

3.154.  The INN is the accreditation body in Chile. Through its Accreditation Division, it operates the National Accreditation System, which evaluates the competence of conformity assessment bodies (CABs) in accordance with internationally defined and accepted criteria and requirements. While accreditation is voluntary, the regulatory authority sometimes requires accreditation in the National Accreditation System of the INN in order to authorize and recognize certification bodies, inspection bodies and laboratories

3.155.  According to the authorities, the National Accreditation System complies with the principles of transparency, confidentiality, independence and impartiality. To this end, the National Accreditation System applies a policy of impartiality and has a document (DA‑I03) which sets out the sources of income of the INN, available for consultation at the offices of its Accreditation Division.[250]

3.156.  The different types of CAB which may request accreditation include systems certification bodies, products and persons, inspection bodies, testing laboratories, calibration laboratories, medical laboratories and proficiency test providers. CABs wishing to become and remain accredited in the National Accreditation System of the INN must comply with the provisions of the Regulations for the Accreditation of Conformity Assessment Bodies and, as the case may be, with the requirements set out in the corresponding standards.[251] Applicant and accredited CABs shall also consider the specific requirements and provisions for the different areas of conformity assessment activity set forth in standards, regulations, guidelines or other publications.[252]

3.157.  The accreditation process comprises the following main stages: (a) submission of the application; (b) review of the application; (c) initial assessment; (d) review of corrective action, if applicable; (e) accreditation decision; (f) maintenance of accreditation – surveillance assessments; and (g) renewal of accreditation – renewal must be requested one year before the end of the accreditation cycle. Accreditation is granted for a five‑year period. The product certification system does not restrict the country of accreditation bodies, with foreign accreditations allowed for domestic certification bodies

3.158.  Several Chilean institutions recognize as equivalent the technical regulations or conformity assessment procedures of other countries. The main requirements for the recognition of foreign certification are that the certificates must be based on the international standards used in Chile and that the issuer of the foreign certificates is accredited by a signatory member of the International Accreditation Forum (IAF). For instance, in the case of the SEC, the regulations on certification of electrical products and fuel‑related equipment, approved by Decree No. 298 of 2005, provides for the recognition of foreign certification. This recognition makes it possible to obtain the type of certification required in Chile and then, with the regular control or monitoring certification, to obtain the certificate of approval. In the case of SAG, there are equivalence agreements with the European Union and the United Kingdom concerning trade in organic products (2018); unprocessed plant products (only products listed in the Agreement); live animals or unprocessed animal products (only natural honey); processed plant products for use as food, including wine (only products listed in the Agreement); and vegetative propagating material and seeds for cultivation (only products listed in the Agreement). Chile also has an agreement with the European Union on the beef carcass classification (grading) scheme and nomenclature of beef cuts (2016)

3.159.  As regards accreditations issued by Chile's internationally recognized accreditation body, as at 31 December 2022, the INN had 593 accredited entities (CABs) with a total of 1,522 accreditations in force, as a CAB can have more than one accreditation. As of June 2023, 1,502 accreditations were in force.[253]

3.160.  Metrology in Chile is regulated by Supreme Decree No. 215 of 2009 of the Ministry of Economy, Development and Reconstruction, which recognizes the INN as the coordinating and supervising body of the laboratories designated by this Ministry and members of the National Metrology Network (RNM). Supreme Decrees No. 347 of 2007, No. 775 of 1999, No. 487 of 2000, No. 96 of 2001 and No. 76 of 2003, all from the Ministry of Economy, Development and Reconstruction, stipulate the standards of mass, temperature, force, length and pressure and designate the laboratory responsible for chemical metrology for minerals. Supreme Decrees No. 188 of 2010, No. 116 of 2012, No. 69 of 2017 and No. 114 of 2018, all from the current Ministry of Economy, Development and Tourism, designate laboratories in the fields of microbiology and food chemistry, electrical metrology, humidity and ionizing radiation. Supreme Decree No. 158 of 2010, which designated the laboratory in the field of liquid flow, was repealed by Supreme Decree No. 2 of 2022

3.161.  The current Ministry of the Economy, Development and Tourism is responsible for extending membership of the RNM to laboratories, once they have met the requirements laid down by the INN, according to the RNM regulations, in their specific area of metrology. The INN is the coordinating and supervisory authority for laboratories belonging to the RNM and also has the task of administering the public funds transferred to it

3.162.  The RNM consists of a first set of designated laboratories in the area of physics, where instruments and measurement standards are calibrated, and a second set of designated laboratories in the area of chemistry, which are the point of reference in the area of chemical metrology. The RNM performs the functions of a national metrological institute and its main purpose is to establish the groundwork for the national quality infrastructure and thus ensure the quality of products, their interchangeability and the rights of consumers. The RNM coordinates and manages the metrological assurance system, which guarantees that measurements originating in Chile are comparable and traceable to the International System of Units (SI) and accepted in other countries. Their function is to ensure that measurements made in Chile are SI‑traceable. The RNM member laboratories provide SI‑traceability to the industrial calibration and testing laboratories, which serve industry and commerce.[254] The RNM member laboratories also conduct research in metrology and for the development of new measurement standards and methods, and provide standard calibration services to calibration laboratories and reference material to testing laboratories. They also act as pilot laboratories for proficiency testing at the national level

3.163.  The INN supports the establishment of metrology technical committees coordinated by its Metrology Division in conjunction with the designated institutes of the RMN, whose functions include helping to establish the metrological SI‑traceability of measurements carried out in laboratories; helping to disseminate metrological traceability in Chile; and providing tools that allow continuous updating of theoretical and practical knowledge of industrial and scientific metrology to ensure the quality of the results issued by the laboratories

3.164.  The metrology technical committees are composed, in principle, of technical representatives of the existing laboratories in the country, whether accredited, unaccredited or in the process of being accredited. However, preference is given to laboratories that regularly participate in proficiency testing organized by the RNM. Stakeholders whose participation in the committee may be necessary to produce conclusions in relation to its work may be invited to join said committee