3.128.  The main laws governing phytosanitary and animal health policies and measures are the new Organic Law on Agricultural Health, dating from 2017, the Organic Law amending the Organic Law on the Food Sovereignty Regime, and the Organic Law on Health. The Organic Law on Agricultural Health was enacted in order to update and harmonize the national phytosanitary and animal health regulations with the national and international frameworks, and therefore it also repealed various laws.[227] The regulatory framework in this area also comprises a number of other laws, decrees and regulations (Box 3.6)

3.129.  Since 2017, the authority responsible for plant and animal health and food safety in the primary production sector in Ecuador has been the Ecuadorian Plant and Animal Health Regulation and Control Agency (AGROCALIDAD), attached to the Ministry of Agriculture and Livestock (MAG), which took over all the responsibilities of the Ecuadorian Agricultural Product Quality Agency. AGROCALIDAD is responsible for protecting and improving animal and plant health and food safety in primary sector production, including organic production. To this end, it draws up, issues and applies sanitary and phytosanitary measures affecting both domestic production and imports and exports. It works with international bodies such as the International Plant Protection Convention (IPPC), the OIE, Codex Alimentarius and, at regional level, the CAN

3.130.  The Ministry of Public Health regulates and exercises sanitary control of the production, importation, distribution, storage, transport and marketing of processed foods, medicines and other products for human use and consumption, as well as the systems and procedures that ensure their safety and quality.[228] To this end, in 2012 the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA) was established as part of the Ministry.[229] The ARCSA is tasked with ensuring public health through the regulation and control of the quality and safety of products for human use and consumption as well as the hygiene and health conditions of establishments subject to its supervision and control. It issues technical rules and standards and protocols for the sanitary control and surveillance of the products and establishments for which it is responsible[230], and monitors compliance with technical requirements.[231]

3.131.  The ARCSA is responsible for granting, suspending, cancelling or renewing health registration certificates and the mandatory health notifications for cosmetics and hygiene products. It also carries out controls and surveillance in the markets after registration certificates or mandatory health notifications have been obtained. In addition, the ARCSA issues health registration certificates for imports of the products under its control and, in the case of exports, regulates the procedure for obtaining the export health certificate for processed foods, processed food products and medicines manufactured and/or prepared in the country exclusively for export.[232]

3.132.  Since 2017, the Under-Secretariat for Quality and Safety of the Ministry of Aquaculture and Fisheries (MAP) has been responsible for health, quality and safety policy in the aquaculture and fisheries sector.[233] It replaced the National Fisheries Institute as the authority responsible for health controls, official inspection of establishments, analysis of fishery and aquaculture products, and product safety certification for exports. Currently, the National Fisheries Institute carries out scientific and technological research on biological ocean resources with a view to diversifying production, promoting the development of fisheries and optimizing their utilization

3.133.  AGROCALIDAD has responsibility for drawing up plant and animal health measures for the primary sector: its various technical coordination units have procedures for the proper elaboration of regulations in each area within its competence.[234] These procedures generally include the stages of drafting, adoption and publication of the rules, followed by implementation. They are prepared with the technical support of the stakeholders producers, importers and/or exporters

3.134.  According to the authorities, the main legal provisions relating to plant health are harmonized with the IPPC guidelines. A number of resolutions have been issued laying down the phytosanitary requirements for imports of plants, plant products and other regulated articles, as well as the procedure for import and export controls and the new list of quarantine pests not present in Ecuador, among others (Box 3.7). AGROCALIDAD's Food Safety Directorate has published a number of handbooks of general agricultural and livestock good practices.[235]

3.135.  In the case of imports of animal products, the official veterinary service in the country of an enterprise wishing to export its products to Ecuador must forward the exporter's request to AGROCALIDAD together with information on the health status of the species concerned and information on the enterprise and its establishments. This information is assessed by AGROCALIDAD's General Animal Health Coordination Office, which reserves the right to request additional information and carry out an in situ inspection. The result of the evaluation of the exporting country's sanitary status will be communicated to that country. If the result is favourable, the process of authorizing the enterprise (and its establishments) wishing to export to Ecuador will be initiated. Enterprises have to submit specific information, through the official veterinary service of their country of origin, to the General Animal Health Coordination Office, which reserves the right to request additional information and carry out an in situ inspection. The result of the evaluation will be transmitted to the official veterinary service of the country concerned

3.136.  The approval of the enterprise and its establishments wishing to export animal products to Ecuador is valid for three years. In the event of changes in the sanitary status of the country of origin or the enterprise, AGROCALIDAD may stop issuing animal health import permits and suspend the approval of the enterprise (and its establishments) until the official veterinary service of the country of origin provides the necessary information, and also, where appropriate, carry out an in situ inspection. The costs involved in the approval process are borne by the interested parties (public and/or private institutions) wishing to export to Ecuador. Requests for renewal must be made by the official veterinary service of the country concerned at least 30 days prior to the expiry of the approval of the enterprise (and its establishments). Once this period has expired, animal health import permits will no longer be issued. The renewal will be granted provided there have not been any changes in the sanitary status of the country of origin or in the production operating procedures of the enterprises and their establishments

3.137.  In the case of exports of agriculture and fishery products, the MAP Under-Secretariat for Quality and Safety draws up and maintains a register of natural or legal persons authorized to export. Establishments wishing to be included in the register must comply with the technical protocols and the verification of their health conformity for the Under-Secretariat for Quality and Safety to be able to issue the official guarantees required by the various markets of destination for the fishery and aquacultural products to be exported. The Under-Secretariat for Quality and Health is responsible for the sanitary control and regulatory inspection of all establishments and entities in the traceability and processing chain for fishery and aquacultural resources intended for export

3.138.  AGROCALIDAD is the designated agency for notifying sanitary and phytosanitary measures to the WTO Committee on Sanitary and Phytosanitary Measures. During the period 20122018 (July), Ecuador submitted some 120 notifications to the Committee (not counting addenda). Of these, 11 notifications concerned emergency measures (two relating to plant protection and the others to animal health). As for the remaining measures notified to the Committee, some were adopted in order to protect animal health and food safety, but most concerned the protection of plants and the territory against harm from pests. Generally speaking, the notified measures apply to regions or trade partners affected by the disease or pest against which the country is seeking to protect itself. Most of them are based on international standards; in only a few cases it is specified that there is no relevant international standard or that the measure is not in conformity with the international regulations. During the period 2012-2018 (July), Members did not question the phytosanitary and animal health measures notified by Ecuador.[236]

3.139.  In 2018, 1,124 ten-digit tariff lines were subject to sanitary and phytosanitary measures. These concerned in particular fruit and vegetables (HS Chapters 08 and 07), wood, wood charcoal and articles of wood (HS Chapter 44) and meat and edible offal (HS Chapter 02) (Chart 3.9). These products require an animal health import permit as well as other customs control documents (such as a prior control document, a customs destination document or importer registration) as supporting documents for the import customs declaration.[237]

3.111.  The legal framework governing the standardization system in Ecuador consists primarily of the Constitution, the Ecuadorian Quality System Law and its implementing regulations[217], as well as other manuals, ministerial decisions and resolutions, and the rules of the Andean Community (CAN) (Table 3.5)

3.112.  The Ecuadorian Quality System Law governs, inter alia, the principles, policies and entities concerned with conformity assessment activities. It also ensures compliance with citizens' rights and international commitments in this area. The guiding principles of the Ecuadorian quality system include fairness and national treatment: accordingly, domestic and imported goods and services are treated in the same way, and the technical regulations and conformity assessment procedures of other countries are recognized provided they are suitable for Ecuador. In addition, the participation of all sectors in the development and promotion of quality and dissemination of information is guaranteed

3.113.  The Ecuadorian Quality System is the set of processes, procedures and public institutions responsible for the implementation of the quality and conformity assessment principles and mechanisms. The Ministry of Industry and Productivity (MIPRO) is the leading institution of the system. In addition to MIPRO, the system consists of the Inter-Ministerial Committee on Quality, the Ecuadorian Standardization Service (INEN), the Ecuadorian Accreditation Service (SAE), and the government entities and institutions which, according to their remit, may issue standards, technical regulations and conformity assessment procedures, including the Ministries of Electricity and Renewable Energy (MEER), Public Health (MSP), the Environment (MAE), Tourism (MINTUR), Agriculture and Livestock (MAG), Aquaculture and Fisheries (MAP), and Transport and Public Works (MTOP), as well as the Provincial Councils and the Municipalities

3.114.  The Ecuadorian Standardization Service (INEN) is the technical body responsible for regulation, standardization and metrology activities. It is assisted by the Inter-Ministerial Committee on Quality, which coordinates intersectoral quality policy and comprises various ministers or their representatives.[218]

3.115.  The standardization process begins with the identification of national standardization needs, which involves evaluating the possible impact of such rules. On the basis of this analysis, the priority areas are identified and included in the Annual Standardization Programme (Chart 3.7). This programme is drawn up by the INEN and included in the National Standardization Plan, which is in turn part of the National Quality Plan, an annual plan adopted by the Inter-Ministerial Committee on Quality

3.116.  Working drafts of standards are assigned to the various technical departments, which study them taking into account the respective technology, bibliography, publications and international standards. The working draft becomes a "draft standard" when the technical department submits it to the technical committee consisting of all interested parties: academic circles, public bodies, industry, chambers and consumers. Once approved by the technical committee, draft standards are published for public consultation (Chart 3.7). They may be consulted on the INEN website for 60 days in the case of the normal procedure or 15 days in the case of an accelerated procedure, which arises in the event of a national emergency or to address a situation impairing the country's legitimate objectives

3.117.  The draft standard then undergoes a quality control to check that it complies with the standardization principles, contains the applicable and demonstrable requirements, and complies with the internal standardization procedures. Once the document has undergone quality control, it is edited and sent to the MIPRO Under-Secretariat for Quality to be approved and officialized and then finally published in the Official Register (Chart 3.7)

3.118.  Standards are systematically reviewed every five years to assess their validity. Nevertheless, they may be reviewed earlier if standardization needs so warrant. Following this assessment, standards may be revised, modified or eliminated

3.119.  Notwithstanding the voluntary nature of technical standards, the authorities may make compliance with them mandatory through a technical regulation. Technical regulations are issued to preserve safety, human, animal and plant health, the environment and consumer protection. They must be in the interests of the national economy and in line with the current state of development of science and technology as well as with the country's climatic and geographical specificities. However, the authorities indicated that technical regulations are governed by the principles of national treatment, non-discrimination, equivalence and transparency, as set out in the international treaties, conventions and agreements in force in Ecuador

3.120.  Technical regulations are prepared by central, provincial and municipal government entities.[219] MIPRO is the leading body of the Ecuadorian Quality System and issues the Ecuadorian Technical Regulations (RTEs) with the technical support of the INEN (RTEINEN).[220] In July 2018, 232 RTEINEN regulations were in force. They must be reviewed, like standards, at least every five years with the technical support of the public and private sectors.[221] According to the authorities, they are updated or modified in line with international and/or sectoral needs. Chart 3.7 Standardization process

3.121.  During the period 20122018, Ecuador submitted 207 regular notifications and 25 emergency notifications to the WTO TBT Committee through MIPRO's Under-Secretariat for Quality, Ecuador's national contact point and/or information centre for the WTO. The notifications related to: consumer protection and the prevention of misleading practices; protection of human health or safety; and quality requirements. Nine of these measures concerned labelling

3.122.  Members questioned Ecuador's technical regulations on 18 occasions during the review period. Measures that have been questioned several times include the labelling system for processed food for human consumption, and the procedure for obtaining a Certificate of Recognition or conformity verification certificate (form INEN-1).[222] This certificate, which is issued by the INEN, is a supporting document for the import customs declaration for certain goods subject to technical regulations when the value exceeds USD 2,000, except in the case of textiles, clothing and footwear, for which there is no threshold.[223] In 2018, 1,152 ten-digit tariff lines were subject to technical regulations. The goods involved are mainly motor vehicles (HS Chapter 87), clothing and accessories (HS Chapters 61 and 62) and electrical machinery and equipment (HS Chapter 85) (Chart 3.8)

3.123.  The Ecuadorian Accreditation Service (SAE) is responsible for conformity assessment accreditation in Ecuador, for which it has the power to accredit the technical competence of conformity assessment bodies; supervise such bodies; and determine the technical conditions under which they may offer their services.[224] Conformity assessment bodies that may operate in Ecuador include public or private entities accredited by the SAE and foreign bodies with which mutual recognition agreements have been signed or that have been so designated by MIPRO. The latter may also temporarily designate other foreign bodies, where the service cannot be provided by the entities authorized to operate in Ecuador

3.124.  Before they can be marketed, both domestic or imported products subject to a technical regulation must have a certificate of conformity issued by a certification body accredited in Ecuador or issued in accordance with the mutual recognition agreements in force. Each technical regulation establishes the procedure for demonstrating the conformity of the product. In the case of government procurement of goods and services, it is also necessary to establish compliance with quality requirements through a conformity certificate

3.125.  Products that have the INEN Quality Seal Certificate of Conformity (INEN Quality Seal) do not need a conformity certificate to be marketed. The INEN Quality Seal, which began to be used in 2015, is obtained upon application[225]: the INEN grants the seal when a product is manufactured under an INEN-approved quality system and permanently complies with the requirements established in the relevant technical regulation. The Seal is valid for three years, renewable for three consecutive years.[226] Enterprises must pay for the technical services, for example, tests, audits to determine product quality or audits of the enterprise quality management system carried out by INEN in order to be able to grant the Seal

3.126.  Ecuador has a National Calibration System to guarantee the uniformity and reliability of measurements made in the country both with respect to commercial and service transactions as well as for industrial processes and scientific and technological development research work. The National Calibration System consists of the INEN National Metrology Laboratory, the laboratories designated as primary laboratories for the safe custody of national calibration standards, and accredited calibration laboratories. The National Metrology Laboratory issues the appropriate metrology procedures

3.127.  The INEN manages the National Calibration System and coordinates the necessary activities for determining the accuracy of the calibration standards and instruments used by the accredited laboratories in order to ensure uniformity and reliability of the measurements