3.138.  El Salvador's legal framework for sanitary and phytosanitary measures (SPS) has not substantially changed since the most recent trade policy review. This framework is mainly made up of the Law on Plant and Animal Health[183], the regulations on the preparation of standards containing phytosanitary and animal health measures in accordance with the Law on Plant and Animal Health[184], the Health Code, the National Law on Organic Farming[185], and the Law creating the Salvadoran Quality System, as well as other legislation. The WTO's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) has been incorporated into domestic law in El Salvador

3.139.  Recently, the authorities have drawn up a draft law to protect health, animal health and food safety, which sets out to modernize national regulations and adapt them to international standards in order to facilitate trade, while also ensuring sanitary and phytosanitary protection. A new aspect of the proposed law is the chapter on the safety of food of animal and plant origin, which establishes the basis for certification processes for foods of animal origin, for the seizure of foods suspected of posing a danger to human and animal health, and for measures to prevent food adulteration. It also explicitly recognizes the standards and guidelines of international reference organizations. At the time of writing this report (late 2022), the proposed law was expected to be subject to public consultation, before being submitted to the legislature

3.140.  The Directorate for the Administration of Trade Agreements (DATCO) within the Ministry of Economic Affairs serves as the national enquiry point and is responsible for notifications under the SPS Agreement. El Salvador submitted 33 notifications to the WTO's Committee on Sanitary and Phytosanitary Measures (SPS Committee) between January 2016 and November 2022.[186] Of these notifications, half related to RTS and RTCA and the rest concerned updates to existing technical regulations. A 60‑day consultation period was set for all of these notifications, with the exception of some notifications relating to emergency measures. The products covered by the notifications include drinking and waste water, salted fish, poultry, livestock (sheep and cattle), coffee, veterinary medicines and dairy products. Of the total, eight referred to an international standard (Codex Alimentarius, WOAH or IPPC). During the review period, no WTO Member has raised a trade concern in the SPS Committee regarding El Salvador's sanitary or phytosanitary measures

3.141.  El Salvador applies the Central American Regulations on Sanitary and Phytosanitary Measures and Procedures, whose purpose is to ensure that sanitary and phytosanitary measures do not directly or indirectly affect intraregional trade.[187] El Salvador recognizes registration certificates issued by the regulatory authorities of CACM member countries for fertilizers, pesticides and other agricultural inputs[188], as well as those for medicines for human use that have been registered pursuant to harmonized legislation.[189] It also recognizes the sanitary registration certificates for food and beverages issued by Guatemala, Honduras, Nicaragua and Costa Rica.[190] Under the CAFTA‑DR Agreement, El Salvador recognizes the equivalence of the United States meat and poultry inspection system, and, since 2018, has accepted certificates from the Seafood Inspection Program of the National Oceanic and Atmospheric Administration for fish and seafood farmed and cultivated in the United States. El Salvador also recognizes the equivalence of Chile's sanitary measures for fishery product inspection systems.[191] Under the Association Agreement between Central America and the European Union, El Salvador recognizes the inspection systems for establishments processing products of animal and plant origin for human consumption in European Union member States. El Salvador has not notified the WTO's SPS Committee of any agreement that recognizes the equivalence of measures

3.142.  El Salvador is a member of the World Organisation for Animal Health (WOAH) and has signed the International Plant Protection Convention (IPPC). The Ministry of Agriculture and Livestock is the focal point for both organizations. El Salvador is also a member of the Codex Alimentarius Commission and its focal point is OSARTEC. In 2021, the National Codex Committee endorsed the Strategic Plan of the National Codex Programme 2022‑24, the main objectives of which are to ensure the availability of safe food, protect consumers' health and facilitate international food trade.[192] At a regional level, El Salvador belongs to the International Regional Organization for Plant and Animal Health (OIRSA)

3.143.  The Ministry of Agriculture and Livestock (MAG), through the Directorate‑General of Livestock (DGG) and the Directorate‑General of Plant Health (DGSV), issues regulations on animal and plant health, agricultural quarantine and the registration and control of agricultural inputs. The MAG follows the same procedure for drafting and adopting SPS measures as that followed for technical regulations (Section 3.3.2). The Ministry of Health, through the Food and Beverages Unit of the Environmental Health Directorate, is responsible for issuing regulations for ensuring food safety

3.144.  The MAG has the power to issue regulations and determine procedures for the entry and transport to and within the national territory of plants and animals, the products and by‑products thereof.[193] Imports will be admitted only if they come from countries whose inspection systems, veterinary services, systems for food safety and phytosanitary surveillance of quarantine pests and diseases have been assessed and approved by the DGG or the DGSV, as appropriate. In the event that the exporting country's system has not been approved, imports may only come from individual plants or establishments approved by the DGG or the DGSV. Based on the findings of their assessments, the DGG and DGSV may impose sanitary or phytosanitary requirements as a condition for allowing imports. The requirements will vary based on the product's level of risk and may take the form of a certificate issued by the exporting country, inspection at the point of entry, special treatment or quarantine. With regard to pest risk analysis, the authorities have stated that they apply ISPM No. 1

3.145.  El Salvador does not require importers of plants, animals or their products and by‑products to be included in a special register. However, an authorization issued by the MAG is required to import the majority of these products, in addition to the official sanitary or phytosanitary certificate issued by the authority of the country of origin. The Agricultural Health Information System (SISA) is an online database, managed by the MAG, where the sanitary and phytosanitary requirements applying to specific products may be consulted, together with the products and countries of origin for which a sanitary/phytosanitary evaluation by the MAG's competent authorities is a prerequisite for imports.[194] In order to facilitate trade, the MAG is involved in the CIEX platform, where users can register and generate most sanitary and phytosanitary import authorizations online, as well as import visas for agricultural inputs (Section 3.1.1.1)

3.146.  According to the Health Code, the Ministry of Health (MINSAL) is responsible for determining the minimum requirements for food, whether it is produced in the country or imported.[195] The procedure for drafting and adopting these requirements is the same as that for technical regulations

3.147.  In order to import processed food or beverages, authorization must be obtained from MINSAL and a sanitary registration certificate must first be issued by the Food and Beverages Unit of the Environmental Health Directorate of MINSAL.[196] Sanitary registration is required both for national and foreign products. In March 2022, MINSAL introduced changes to the sanitary registration process for pre‑packaged food and beverages.[197] The objectives of these changes include streamlining the procedure by allowing temporary registration and facilitating accreditation of certificates of free sale or equivalent documents issued by the authorities of the exporting countries. The sanitary registration requirements for food and beverages produced abroad are summarized in Box 3.2

3.148.  The sanitary registration application is processed through the Comprehensive Environmental‑Health Information System (SISAM) of MINSAL, which is linked to CIEX and the Regional Sanitary Register Integration System (SIRRS). Provided they meet the requirements, within eight working hours of submitting the application, importers will receive a temporary registration which is valid for three months. If the subsequent laboratory test results are satisfactory, the registration will become definitive, which is valid for five years. SISAM enables users to view the full list of their sanitary registrations and their applications.[198]

3.149.  As a general rule, laboratory analyses are performed by the National Public Health Laboratory, which is an agency of the National Institute of Health. Private laboratories may perform analyses on national holidays only, in which case, these analyses must be validated subsequently by the Laboratory for Food Quality Control and Toxicology of MINSAL.[199] Source: Secretariat of the WTO, based on information from the MINSAL transparency portal. Viewed at: https://www.transparencia.gob.sv/institutions/minsal/services/1010

3.150.  Importers of foods and beverages who have already registered with the sanitary register must submit an online import application for each operation through CIEX. To this end, importers must be registered in SISAM and in the CIEX Foreign Trade Facilitation System, must complete the import application and must be duly registered in the sanitary register. The authorization is issued automatically.[200] The same procedure is followed for the accreditation of food and beverage sanitary registration certificates issued by the authorities of CACM member countries. El Salvador also recognizes the food and beverage sanitary registration certificates from member countries of the European Union and from the United Kingdom, pursuant to the respective partnership agreements in force

3.151.  As stated in the previous TPR report, genetically modified foods may be imported into El Salvador, provided that they comply with the provisions of the Special Regulations on the safe handling of genetically modified organisms.[201]

3.152.  The National Directorate of Medicines (DNM), an autonomous legal public entity, is responsible for regulating and overseeing pharmaceutical products, cosmetics and hygiene products, chemicals and medical devices.[202] Each of these product categories has its own sanitary register, managed by a different unit of the DNM.[203] Persons wishing to import these products must register as importers with the DNM, file a power of attorney form (authorizing the distribution of the product, or designating a responsible qualified pharmacist‑chemist or a responsible legal representative) and, subsequently, enter their products in the relevant sanitary register

3.153.  For medicines, the main sanitary registration requirement is the Certificate of Pharmaceutical Product issued by country of origin, in accordance with the format recommended by the World Health Organization (WHO). If it is not available, importers may submit a good manufacturing practices (GMP) certificate or a certificate of free sale from the country of origin.[204] In addition, potential importers must submit an analysis certificate issued by the manufacturer's quality control laboratory. However, the DNM also reserves the right to request additional laboratory tests. El Salvador recognizes the sanitary registration certificates for cosmetic products issued by the authorities of other CACM countries. For medical devices, it recognizes products registered with a level 4 regulatory authority, as classified by the WHO

3.154.  In addition to being registered in the sanitary register, a permit is required to import products regulated by the DNM, which is processed through CIEX. A guide to this process is available to view online.[205]

3.123.  The Agreement on Technical Barriers to Trade (TBT Agreement) became national law as a result of the ratification of the Marrakesh Agreement in 1995.[172] The enquiry point provided for in Articles 10.1 and 10.3 of the TBT Agreement is the Directorate for the Administration of Trade Agreements (DATCO) of the Ministry of Economic Affairs, which is also responsible for submitting the notifications required by the Agreement. During the review period, no specific trade concerns were raised in the TBT Committee about measures applied by El Salvador

3.124.  El Salvador submitted 58 notifications to the TBT Committee between January 2016 and July 2022.[173] Approximately a third of the notifications related to foodstuffs (ground and green coffee beans, dried fish, poultry and dairy products), with the objective of ensuring food safety and protecting human health. Another third of the notifications related to domestic electrical appliances (refrigerators, air conditioners and lighting equipment), with the aim of preventing deceptive practices and ensuring consumer protection. Due to the COVID‑19 pandemic, pursuant to Article 2.10 of the TBT Agreement, four emergency technical regulations on medical devices and medicines for human use were notified, as well as others relating to information technologies. These technical regulations remained in force for one year and, upon expiration, the usual regulatory drafting process was followed, with a 60‑day national and international consultation period and the relevant notification to the WTO. The other notifications followed this 60‑day time frame and, in some instances, this period was extended. El Salvador has not notified the WTO of any mutual recognition agreement on technical regulations, conformity assessment procedures or standards

3.125.  The legal‑institutional framework established in 2011 by the Law creating the Salvadoran Quality System[174] has not been substantially amended during the review period. The National Quality Council is the governing body of the system, and is, in turn, made up of four technical bodies: the Salvadoran Technical Regulation Agency (OSARTEC), the Salvadoran Standardization Agency (OSN), the Salvadoran Accreditation Agency (OSA) and the Metrological Research Centre (CIM). The most recent amendment to the Law creating the Salvadoran Quality System, enacted by Legislative Decree No. 40 of 5 June 2021, made some changes to the membership of the National Quality Council without changing its rules

3.126.  The Salvadoran Technical Regulation Agency (OSARTEC) is responsible for coordinating the adoption, adaptation, updating and publication of Salvadoran mandatory technical regulations. These instruments are known as Salvadoran Technical Regulations (RTS) and were originally referred to as Salvadoran Mandatory Standards (NSO), prior to the Law Creating the Salvadoran Quality System. In accordance with the Law, all technical regulations applied by El Salvador must comply with the TBT Agreement and with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). OSARTEC's functions include ensuring compliance with existing international guidelines and with El Salvador's commitments in the area of technical regulations

3.127.  The authorities have indicated that the majority of RTS included in their conformity assessment procedures are based on international standards.[175]

3.128.  As a member of the Central American Common Market (CACM), El Salvador applies the Central American Regulations on Standardization Measures, Metrology and Authorization Procedures[176] and the Central American Guide to Good Regulatory Practices[177] and its annexes, when drafting Central American Technical Regulations (RTCA). As part of its efforts to eliminate any inconsistencies between NSO, RTS and RTCA, OSARTEC has, since 2011, repealed 29 NSO and has replaced them with RTS or RTCA[178], and plans to take steps to repeal 12 more. OSARTEC has online databases of all of the technical regulations in force. In July 2022, there were 32 RTS, 81 NSO and 92 RTCA.[179] In the Salvadoran system, there are no legal provisions requiring a technical regulation be updated or expire within a specific time period, instead these steps are taken as and when necessary

3.129.  The procedures for drafting RTS have not changed during the review period. They are based on the Handbook of Good Technical Regulation Practices drawn up by OSARTEC, which sets out the principles for and stages of drafting, reviewing and approving technical regulations, including public consultation and international notification. The steps are outlined in Chart 3.2. At the time of writing this report, OSARTEC was updating the Handbook, with a view to turning it into mandatory regulations for drafting Salvadoran Technical Regulations; the final version is expected to be ready before the end of 2022

3.130.  Natural and legal persons and government bodies may ask OSARTEC to draw up technical regulations. OSARTEC determines whether the request should be included in the Annual Technical Regulations Plan. If OSARTEC decides to include the request, it checks whether the draft technical regulation is in line with international standards. OSARTEC then sets up a national technical regulation committee, composed of public sector representatives, which is responsible for drawing up the draft technical regulation and addressing any related comments. It then sets up a consultation committee involving all relevant sectors in order to come to an agreement on the draft technical regulation. The regulation will then be subject to national and international public consultation for 60 calendar days, which may be extended by a further 30 days. Any comments received are reviewed in meetings convened by OSARTEC, attended by representatives of the public and private sectors, academia and consumers. Once the technical regulation has been approved by the National Technical Regulation Committee, OSARTEC submits it for endorsement to the competent regulatory authority, which issues the relevant legal instrument and publishes it in the Official Journal

3.131.  El Salvador applies technical regulations on labelling for products such as textiles, footwear, cosmetics, medicines, food and beverages

3.132.  The Salvadoran Standardization Agency (OSN) is responsible for drafting, updating, adopting, adapting, repealing and publishing Salvadoran Technical Standards (NTS) which facilitate conformity assessment. Unlike RTS, NTS are voluntary. According to the OSN catalogue, in July 2022, there were 1,522 technical standards in force in El Salvador. The most common NTS refer to food technologies (almost a third of the total), followed by, inter alia, management systems, construction materials, health, industrial safety and occupational hygiene, technical design, information technology, textiles and tourism.[180] The OSN is also responsible for developing an annual standardization programme; under the 2022‑23 programme, 90 standards are expected to be drawn up, mainly in relation to health and food. With regard to conformity assessment, the OSN provides certification services that take into account national and international standards. To date, it has developed seals of quality and given certifications for biosecurity, tourism quality, quality management and products

3.133.  Any interested party may ask the OSN to create a new Salvadoran Technical Standard. In such cases, the OSN sets up a technical standardization committee (CTN), comprising public and private actors, which reviews the request and prepares a draft technical standard. This draft technical standard is then subject to public consultation for 30 days if it is an identical copy of an existing international standard, or for 60 days if the standard is new and unique to El Salvador. The CTN reviews any comments made and develops the draft standard, which is submitted to the OSN for approval. Once the standard is approved, steps are taken to publish it

3.134.  The OSN represents El Salvador at the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the American Society for Testing and Materials (ASTM). At the regional level, El Salvador is a member of the Pan American Standards Commission (COPANT), the Central American and Caribbean Standardization Commission, and the Inter‑American Metrology System (SIM). Source: OSARTEC, Guía de Buenas Prácticas de Reglamentación Técnica. Viewed at: http://osartec.gob.sv/?servicios=guia‑de‑buenas‑practicas‑de‑reglamentacion‑tecnica

3.135.  The Salvadoran Accreditation Agency (OSA) is responsible for accrediting calibration, testing or sampling laboratories, inspection agencies, certification agencies and any other compatible system. In accordance with the Law creating the Salvadoran Quality System, the OSA must work on the basis of the criteria laid down in the ISO standards and guides, the guidelines of Inter‑American Accreditation Cooperation (IAAC), the International Laboratory Accreditation Cooperation (ILAC), and the International Accreditation Forum (IAF) The requirements for requesting accreditation and the steps that must be followed are set out on the OSA website.[181]

3.136.  During the period under review, El Salvador continued to expand its network of accredited conformity assessment bodies. In 2022, 87 public and private institutions were accredited: 64 testing laboratories, 8 calibration laboratories, 4 clinical laboratories, 11 inspection bodies and 2 management‑system certification bodies. The OSA has received international accreditation from the IAAC and ILAC for its testing laboratories (2014), calibration laboratories (2017) and inspection bodies (2018), and is expected to obtain accreditation in additional areas soon. Consequently, the results of OSA‑accredited bodies are recognized in more than 100 countries

3.137.  The Metrological Research Centre (CIM) is the technical body responsible for scientific, industrial and legal metrology in El Salvador. In addition to coordinating the national metrology system, its functions include acting as the national laboratory for the Salvadoran Quality System, maintaining national measurement standards, ensuring the dissemination of the standards and traceability to the International System of Units (SI), providing research laboratories and verification agencies with services for calibrating measuring standards and instruments, and issuing the relevant certificates.[182]