3.103.  The State has the obligation to guarantee safe and healthy food and therefore to make food, pharmaceuticals and products in general subject to appropriate safety and quality criteria.[205] SENASAG was created within the MDRyT in 2000 to carry out this task. It is responsible for administering the Agricultural Health and Food Safety Regime.[206] The MDRyT has exclusive competence for drawing up national policies, standards and strategies to guarantee agricultural health and food safety. It does so in close cooperation with various ministries and government institutions such as the Ministry of the Environment and Water, the Ministry of Health and Sports, the ANB, and IBMETRO. A Plurinational Agricultural Health and Food Safety Committee has also been established to coordinate between the Government and representatives of the agricultural and agro-industry sectors in preparing and evaluating animal health policies. The Committee is chaired by the MDRyT and is composed of representatives of the Ministry of Health, the MDPyEP, SENASAG and the private sector.[207]

3.104.  Agricultural health and food safety are national priorities. The 2011 Agricultural Health and Food Safety Policy accordingly provides for the State to strengthen services that protect agricultural health and food safety by preventing and controlling disease, conducting epidemiological surveillance, controlling the quality of inputs and certifying products.[208]

3.105.  The Agricultural Health and Food Safety Regime is regulated by both domestic and supranational legislation (Table 3.14)

3.106.  Among other tasks, SENASAG proposes and implements the policies needed to ensure protection of plant and animal health and food safety (Table 3.15). Sanitary and phytosanitary measures include inspection, quarantine, surveillance, certification, prevention, control of pests and diseases, registration, diagnosis, laboratory analysis and dealing with sanitary and phytosanitary emergencies

3.107.  In drawing up sanitary measures, the Bolivian authorities refer to the rules of international organizations such as the OIE (animal health), the Codex (safety) and the IPPC (phytosanitary aspects). The National Codex Alimentarius Committee is an interinstitutional and multidisciplinary body responsible for adapting rules so as to protect human health and harmonize food standards.[209]

3.108.  The steps in drawing up a phytosanitary or animal health measure include the following: preparation of a draft; its publication for a period of 30 days (for phytosanitary measures) or 14 days (for animal health measures) to allow the public to make any comments; revision of the project if necessary; and adoption of the measure (Chart 3.10). Phytosanitary and animal health measures enter into force by means of a supreme decree, a ministerial resolution or a SENASAG administrative resolution, as applicable.[210] A phytosanitary or animal health measure may be revised at the request of a party and/or if the sanitary situation changes. The measures are mandatory

3.109.  In order to determine the phytosanitary or animal health requirements for importing plant or animal products or by‑products into Bolivia, the person concerned must file an application with SENASAG to import the product. On the basis of this application, a note is sent to the competent service enquiring about the phytosanitary state of the crop in the country of origin. Once this information has been obtained officially, a risk analysis to detect pests is conducted and the phytosanitary measures decided. The same procedure applies to animal health measures. In both instances, general and specific requirements by product or species are determined

3.110.  SENASAG is responsible for certifying the health-safety status of products for domestic consumption, as well as imports and exports (where necessary). Pursuant to the sanitary control system for the protection of consumers, SENASAG issues the sanitary and phytosanitary import permits prior to loading in the country of origin.[211]

3.111.  Bolivian companies producing or packaging foods may voluntarily apply the Hazard Analysis and Critical Control Points (HACCP) system. Companies wishing to obtain HACCP certification must request it from SENASAG. After SENASAG has conducted an audit to check that the company is applying the system in accordance with the prescribed requirements, it issues a certificate of approval and implementation of the HACCP system.[212] Although it is not compulsory to apply the HACCP system, Bolivia has other technical regulations which must be applied in order to ensure that proper practices are followed when handling food. For example, slaughterhouses must be registered in the Sanitary Register of Slaughterhouses, which can only be done if they meet the requirements prescribed in the various technical regulations issued by SENASAG. Failure to comply with these directives leads to closure of the slaughterhouse. At present (2017), Bolivia applies technical regulations for the operation of slaughterhouses for animals for slaughter, slaughterhouses for bovine animals and slaughterhouses for poultry, and for the inspection of these slaughterhouses and the processing, storage and transport of meat

3.112.  Bolivia has submitted four notifications to the WTO Committee on Sanitary and Phytosanitary Measures since 2006. One of these concerns food safety and animal health[213], while the other three concern plant protection measures.[214]

3.100.  Pre‑packaged or pre‑wrapped foods marketed in Bolivia must be labelled, irrespective of whether they are imported, or processed or packaged in the country.[200] Both imported and locally produced foodstuffs must indicate the following: the name of the food, net content, ingredients and additives, identification of the batch, date and instructions for conservation, name or trade name and address of the manufacturer or importer in the case of imported foods, place or country of origin, sanitary registration number, and importer's tax registration code or number.[201] If the original label on imported products is not in Spanish, an additional label may be added showing information in the required language. The model for the label must be approved by SENASAG, which checks that the proper model is being used. Importers may label products when they reach their destination.[202] SENASAG imposes a fine amounting to 20% of the value of the goods if the importer or distributor does not comply with the labelling requirements.[203]

3.101.  The Law on the promotion of healthy food (Law No. 775) of 2016 regulates the labelling of foods and non‑alcoholic beverages. A coloured bar system (red, yellow and green) must be used to indicate the amounts of sodium, sugar and saturated fats they contain. Transgenic fat content must also be indicated.[204]

3.102.  Supreme Decree No. 2452 of 2015 regulates the labelling of locally produced or imported foods containing or obtained from genetically modified organisms (GMO). Such products must bear a label indicating GMO. This requirement is gradually starting to be applied. By the end of 2017, all processed foods containing GMOs will have to meet this requirement and unprocessed agricultural products will have to do so by the end of 2018

3.91.  Supreme Decree No. 24498 of 1997 created the Bolivian Standardization, Metrology, Accreditation and Certification System (SNMAC), whose goal is to promote competiveness and quality, to guarantee the safety and health of human, animal and plant life, and to protect the environment and consumers.[186] According to information provided by the authorities, Supreme Decree No. 24498 is being revised

3.92.  The SNMAC is composed of several ministries, the Bolivian Metrology Institute (IBMETRO) and the Bolivian Standardization and Quality Institute (IBNORCA) (Chart 3.5). The MDPyEP is responsible for the system as a whole

3.93.  In August 2017, Bolivia did not have any national regulations on preparing technical regulations. As notified to the WTO, preparation of technical regulations is governed by the Code of Good Practice in the WTO Agreement on Technical Barriers to Trade (TBT).[187] Only five ministries may issue technical regulations (Table 3.13), each issuing technical regulations for areas within its remit and, with the exception of the Ministry of Health, preparing them according to each ministry's internal procedures (Table 3.13). Given the importance of the subject, technical regulations issued by the Ministry of Health have to be prepared according to a handbook of standards and specific rules

3.94.  The stages in preparing a technical regulation, in the MDPyEP for example, include drawing up a draft regulation; publishing it for a period of 60 days, during which comments may be made; adopting the regulation, followed by its entry into force (Chart 3.6). Technical regulations come into force by means of supreme decrees or ministerial or administrative resolutions, depending on the responsibilities of each ministry or as prescribed in a higher‑level legal instrument.[188] A technical regulation is revised upon request by the public or private sector provided that there is technical or economic, legal, environmental or political justification. Technical regulations are mandatory. According to the authorities, it is planned to revise Supreme Decree No. 24498 of 1997 to include a technical regulation protocol establishing a common procedure for preparing technical regulations. At present (in 2017), there is no compendium of technical regulations in Bolivia

3.95.  Since 2006, Bolivia has notified the adoption of three technical regulations to the WTO Committee on Technical Barriers to Trade, concerning protection of the environment, health and consumers.[189] Two technical regulations implemented within the CAN framework were also notified.[190] The Vice-Ministry of Medium and Large-Scale Industrial Production (VPIMGE), which is part of the MDPyEP, is the WTO enquiry point for technical regulations.[191]

3.96.  IBNORCA is a private non‑profit‑making association responsible for standardization, quality certification and conformity assessment of "Bolivian standards" or international standards.[192] It prepares "Bolivian standards" at the request of the public or private sector. "Bolivian standards" are drawn up by technical standardization committees operating in 19 sectors, in which experts from the sector concerned participate (for example, representatives of manufacturers, laboratories or consumers). When preparing "Bolivian standards", the technical committee takes into account the guidelines of the international standardization organizations to which Bolivia belongs, such as the International Organization for Standardization (ISO) or the Pan American Standards Commission (COPANT). The process of preparing a "Bolivian standard" encompasses several stages, including the preparation of the basic document (which has to be adopted by consensus in the technical committee), the publication of the draft "Bolivian standard" (NB) for a period of 60 days so that the public may make comments, its approval by the Governing Council for Standardization (CONNOR) and its subsequent ratification by means of a resolution of the Governing Board (Chart 3.7).[193] "Bolivian standards" are revised every five years by the technical committee which prepared them. Application of an NB is voluntary. According to information provided by the authorities, IBNORCA currently has approximately 3,500 standards registered in its database; of these, some 30% are ISO standards adopted by IBNORCA. The standards in effect are published in a catalogue.[194] IBNORCA acts as the WTO enquiry point for Bolivian standards.[195]

3.97.  IBNORCA is also responsible for certifying that goods comply with "Bolivian standards", international standards and/or technical regulations. The certification process is voluntary, unless the goods are subject to a technical regulation, and is initiated at the request of the interested party (Chart 3.8). Quality certification is given by means of an "N" stamp. The stamp is valid for three years and needs to be verified each year in order to keep it. Any type of good may be certified. Imported goods do not require an "N" stamp in order to be sold on the domestic market. If an imported product is subject to a technical regulation, the conformity certificate for the product has to be submitted either prior to shipment or upon import. IBNORCA also certifies management systems.[196]

3.98.  IBNORCA and other conformity assessment organizations are responsible for assessing the conformity of goods and production processes with "Bolivian standards", international standards and technical regulations. It conducts both mandatory and voluntary inspections consisting of review of the documents or visual inspection and taking samples for all goods subject to "Bolivian standards", international standards and technical regulations. It issues a conformity certificate after carrying out the inspection and also assesses the conformity of imported goods.[197]

3.99.  IBMETRO is responsible for administering the national metrology system and also provides measuring and calibration services. It is in charge of accrediting conformity assessment organizations (OEC), for example, testing and calibration laboratories and inspection and certification organizations.[198] The accreditation procedure is initiated at the request of an OEC (Chart 3.9). In order to grant accreditation, IBMETRO verifies whether the OEC meets the requirements prescribed in the "Bolivian standards" and international standards. Accreditation is given for three years. Once an OEC has been accredited, IBMETRO conducts annual visits to ensure that the requirements that justified accreditation are still being met. An accreditation certificate gives the OEC the right to use IBMETRO's accreditation symbol. To date (2017), IBMETRO has accredited 46 laboratories, four inspection organizations and two certification organizations. The reports issued by accredited laboratories are recognized as official by the State. Accredited organizations are listed in a catalogue published by IBMETRO.[199]