3.124.  Uruguay has a range of laws, decrees and regulations governing phytosanitary and animal health policies and measures (Table A3.4). The basic law on animal health dates back to 1910 and on plant health to 1911. These two laws have been amended and updated by means of further laws and decrees on sanitary programmes for the prevention, monitoring, control and eradication of animal and plant diseases and on the control of imports and exports of animal and plant products.[191]

3.125.  The Ministry of Livestock, Agriculture and Fisheries (MGAP), through its various directorates, is responsible for drawing up phytosanitary and animal health policy and implementing animal, plant and human health protection programmes in the agricultural, agro‑industry and fisheries sectors, as well as monitoring and overseeing compliance with sanitary and phytosanitary standards. The main institutional change made since the last review in 2012 is the establishment within the MGAP of the Directorate‑General of Food Safety Control (DIGECIA) (Table 3.20)

3.126.  The MGAP is tasked with monitoring agricultural products placed on the market to verify their terms of sale, composition and end use. In 2010, the MGAP's remit was extended and it was given the power to authorize or require prior registration for the use, processing, entry, exit or marketing of materials or products for agricultural or livestock use. Facilities in which agricultural or livestock materials or products are prepared, formulated and processed have to be approved by the MGAP. The MGAP also controls and regulates the technical requirements to be met by tools for agricultural use

3.127.  The National Directorate of Aquatic Resources (DINARA), through the Fisheries Industry Department (DIP), is the authority responsible for health and food safety in respect of fishery and aquaculture products, issuing the relevant certificates at the national and international level. The DIP's core mission is to ensure the safety of fishery products, guaranteeing compliance with the regulations issued by the international reference organizations for sanitary standards. The DIP carries out inspections and grants sanitary certificates for the approval of facilities used in the production process and for the performance and/or certification of the analyses required for exports and imports of live fishery products and aquaculture resources. It also handles the design and management of programmes for the prevention, monitoring and control of diseases affecting aquatic animals

3.128.  The fundamental purpose of the Directorate‑General of Food Safety Control (DIGECIA), set up in 2015, is to coordinate and implement policies on biodiversity and on animal health and phytosanitary control, and to advise the minister on formulating and planning policies concerning the safety of food for human and animal consumption. The DIGECIA is also charged with incorporating risk analysis in biosecurity, animal and plant health and food safety decision‑making within the scope of the MGAP, in order to prevent live animals or plants or products, by‑products and derivatives of animal or plant origin that do not meet the prevailing sanitary and phytosanitary requirements from entering the national territory. The DIGECIA is responsible for coordination with other entities on sanitary barriers, food safety and living genetically modified organisms.[192]

3.129.  In the area of food safety, the DIGECIA is tasked with formulating cross‑cutting policies in order to update and reinforce controls guaranteeing the safety of the agri‑food system and to bring them into line with the latest international standards. For food of animal or plant origin and for the primary production stage and some processing stages (depending on the chain), responsibility for formulating and implementing safety policies reverts to the DINARA, the DGSG, the DGSA or the Directorate‑General of Farms (DIGEGRA), as appropriate

3.130.  The National Biosafety Board (GNBio) is responsible for regulating genetically modified plant organisms (GMPOs) and coordinates risk assessment.[193] Genetically modified plants and parts thereof, in whatever form, may only be introduced, used or handled with prior authorization, granted by the Board on a case‑by‑case basis, taking into account the results of the corresponding stages of risk assessment and risk management in respect of the environment, biodiversity, human health, animal and plant health and socio‑economic aspects. The procedure for requesting authorization to introduce, use or handle genetically modified plant organisms and a list of GMPO applications currently being examined in Uruguay can be viewed online.[194]

3.131.  The DGSA is the MGAP service that acts as the National Plant Protection Organization (ONPF) in Uruguay. The ONPF is responsible for proposing the phytosanitary regulations to govern agricultural production and the export and import of plants and plant products. Phytosanitary measures are determined on the basis of pest risk analysis in accordance with the international regulations under the International Plant Protection Convention (IPPC)

3.132.  The DGSG is responsible for ensuring the hygiene and health condition of food and products of animal origin for human consumption, both at the national level and internationally. The DGSG follows the guidelines of the World Organisation for Animal Health (OIE) as a basis for formulating and updating the legal and regulatory framework for activities associated with animal health, veterinary public health and the protection of food and products of animal origin, as well as for checking and certifying the health and hygiene conditions under which animals, genetic material, products of animal origin and inputs for use in animal health and production are imported and exported

3.133.  Setting standards for the fisheries sector and fishery products is the responsibility of the DINARA. These standards apply to fishery products for human or animal consumption, as well as their processing, storage, transport and marketing. The regulations and controls applied by the DINARA follow the guidelines laid down, inter alia, by the FAO/WHO and the Codex Alimentarius

3.134.  The Ministry of Foreign Affairs (MRREE) is responsible for notifying phytosanitary and animal health measures to the WTO Committee on Sanitary and Phytosanitary Measures. During the period 2012‑2017, Uruguay submitted 13 notifications to the Committee (excluding addenda).[195] These measures apply to all of Uruguay's trading partners. Most of them are based on international standards; in two cases only, Uruguay indicates that there is no relevant international standard or that they deviate from international regulations.[196] Some of the measures notified to the Committee were adopted for the sole purpose of protecting animal health, but most of them have multiple purposes, aiming both to preserve food safety and to protect animal health and Uruguayan territory from harmful pests

3.135.  The DGSA, in collaboration with the DGSG, supervises the entry of products within its jurisdiction at the borders. Since its establishment in 2015, the DIGECIA has been in charge of border control of passengers, baggage and vehicles. The entry into Uruguay of products of animal or plant origin or animal feed containing levels of biological residues or other environmental pollutants exceeding those prescribed in the national regulations or in the Codex Alimentarius, as appropriate, may be prohibited.[197] Exports of such products may also be controlled and prohibited for the same reasons, or if they do not comply with the standards required by the countries of destination

3.108.  The Uruguayan Standardization, Accreditation, Metrology and Conformity Assessment System (SUNAMEC)[180] established in 2010, to which the Uruguayan Technical Standards Institute (UNIT) belongs, is an integral part of the framework for developing standardization procedures and assessing the conformity of products and services (calibration, testing, inspection, certification and accreditation) in accordance with international practice.[181] Uruguay, through the UNIT, has accepted the Code of Good Practice for the Preparation, Adoption and Application of Standards set out in Annex 3 to the WTO Agreement on Technical Barriers to Trade

3.109.  The UNIT is Uruguay's national standardization body. It issues standards through various specialized committees composed of representatives of all the sectors involved, which follow a common procedure (Chart 3.5)

3.110.  Standards are issued and revised at the request of an interested party or when it is recognized that, in the public interest, there is a need to develop a standard in a specific field. Once the request has been accepted, a specialized technical committee is set up to prepare, examine and approve drafts of new standards and/or amendments to existing ones. Consumers and producers of both the sector that will be affected and other sectors participate in these technical committees. Once the specialized committee has completed its study and has approved the preliminary draft, the latter becomes a draft. If there is a relevant international standard, it is used as a reference. If the committee considers it expedient, it may submit the draft standard to a public inquiry. Once the draft has been studied and there is a consensus (absence of reasoned objections), it is approved. All drafts approved by the committee are submitted for examination by the General Committee on Standards (CGN). If approved by the CGN, the standard is published and registered in the UNIT Standards Catalogue. There is a charge for access to the Catalogue.[182]

3.111.  There is no mandatory procedure for revising standards. They are revised to the extent that there are changes in the circumstances that led to their being approved. Standards may be revised ex officio or at the request of an interested party

3.112.  In Uruguay there are several agencies that issue technical regulations, including the Ministries of: Industry, Energy and Mining; Public Health; Livestock, Agriculture and Fisheries; and Housing, Land Management and the Environment. Technical regulations are also issued by the Energy and Water Services Regulatory Authority (URSEA) and the Communications Services Regulatory Authority (URSEC). Each follows its own procedures for drawing up technical regulations. The preparation of technical regulations may be initiated ex officio or at the request of a third party. As with standards, there is no mandatory procedure for revising technical regulations. They are revised to the extent that there are changes in the circumstances that led to their being issued. Revision may be ex officio or at the request of an interested party

3.113.  A proportion of the technical regulations adopted by Uruguay involve the adoption of regulations issued at the regional level by the Common Market Group (GMC), MERCOSUR's principal executive body

3.114.  In the period between January 2012 and December 2017, Uruguay submitted 15 technical regulation notifications (21 since 1995) to the WTO Committee on Technical Barriers to Trade. Six of these notifications referred to technical regulations issued by MERCOSUR's GMC. A majority of the regulations related to foods (five notifications), followed by those relating to packaging, marking and labelling (four) and those relating to household cleaning products (three).[183] No questions relating to the measures imposed by Uruguay were raised in the WTO Committee on Technical Barriers to Trade during the period 2012‑2017. Uruguay's TBT enquiry points are by the Ministry of Foreign Affairs (for notifications) and the Ministry of the Economy and Finance (for receiving comments)

3.115.  The National Quality Institute (INACAL), established in 2005, is the organization responsible for quality control. INACAL communicates with the Government through the Ministry of Industry, Energy and Mining. In addition, INACAL, as part of SUNAMEC, guides and coordinates the work of the National Quality System.[184]

3.116.  The UNIT is responsible for certification in Uruguay. It certifies management systems and certain products and services. For certifying products and services, the UNIT has an Independent Quality Certification System for granting the right to use the "UNIT Mark of Conformity with a UNIT Standard" (Marca UNIT de Conformidad con Norma UNIT) to products and services for which UNIT standards have previously been established and which meet the requisite level of quality or specifications. The UNIT grants this mark after assessing the conformity of the product or production process with the specifications of the standard. Since 2010, the UNIT has also been responsible for HACCP certification in Uruguay

3.117.  The Uruguayan Accreditation Agency (OUA), set up in 1998, is tasked with accrediting conformity assessment bodies. The authorities consider that in this way it is helping to facilitate trade in Uruguayan goods and services, since they believe that accreditation increases confidence in goods and services produced in Uruguay.[185]

3.118.  The OUA follows the international standards developed for the accreditation bodies to ensure the impartiality and transparency necessary to generate reliable products and services, with a view to promoting the sale of products and services on the international markets. The OUA is a member of Inter‑American Accreditation Cooperation (IAAC). It is also a signatory to mutual recognition agreements with IAAC and International Laboratory Accreditation Cooperation (ILAC), as a testing and calibration laboratory accreditation agency, and with IAAC and the International Accreditation Forum (IAF), as an agency for the accreditation of bodies certifying quality and environmental management systems and bodies responsible for product certification

3.119.  As regards conformity assessment entities in Uruguay, at November 2017 there were: four management system certification bodies (OCS), including the UNIT; four product certification bodies (OCP), including the National Meat Institute (INAC), the Uruguayan Technological Laboratory (LATU) and the UNIT; 21 accredited testing laboratories, some for specific products such as the National Fuel, Alcohol and Portland Cement Authority (ANCAP) for alcohol, fuel and Portland cement, and others such as LATU, with a more general scope; eight calibration laboratories (LC); one clinical analysis laboratory; and two aptitude testing facilities (PEA), one of them being LATU

3.120.  LATU certifies various products such as: foods, water heaters, helmets, toys, and digital television, following the guidelines of Standard UNIT‑ISO/IEC 17065. LATU gives a written guarantee and establishes that a product, process or service is in conformity with the requirements laid down in the technical regulations

3.121.  LATU also participates in legal metrology activities and may propose draft technical regulations for regulated measuring instruments to the MIEM. The laboratory is also responsible for the metrological control of all regulated measuring instruments. LATU must approve the design of the instrument, carry out initial and regular (annual) checks and, where appropriate, oversee its use. The regulated measuring instruments include scales, taximeters, fuel pumps, meters for commercial use, and tanks for transporting fuel. Checks are also carried out on instruments used in the field of public health, such as clinical thermometers and mechanical and digital sphygmomanometers. In addition, LATU is responsible for maintaining the register of manufacturers, importers and repairers of regulated measuring instruments and is authorized to admit them to and suspend them or exclude them from the register. Since 2012, LATU has also been responsible for checking pre‑measured products.[186] In Uruguay, the packaging of goods marketed according to their weight or size must always indicate the net quantity in the corresponding legal units in order to comply with the labelling and tolerance standards laid down in the technical regulations issued by the MIEM.[187]

3.122.  Some products require a marketing or conformity certificate to be distributed in Uruguay. For example, imported food products and beverages must comply with the domestic bromatological provisions for LATU to grant them a marketing certificate. For this purpose, the importing company must be registered with LATU.[188] Moreover, to be imported a food product must be included in the bromatological register.[189] Apart from food products, steel, toys and tyres require certification. When these products are imported, an import licence is generally required (Table 3.19). Likewise, LATU certifies the quality of various export products; those that require an export certificate include: dairy produce; meat products; fruit and vegetables sold commercially; beekeeping products; bakery products; fermented beverages; suintina (the fatty product obtained by centrifuging the effluents from washing dirty wool); and eggs in the shell. The export certificate is free of charge for products for which it is compulsory, but not for products for which certification is voluntary.[190]

3.123.  Uruguay accepts as equivalent the technical regulations adopted and the tests carried out by trading partners with which it has concluded mutual recognition agreements