3.77.  The Health Code (Decree No. 90‑97) and the Plant and Animal Health Law (Decree No. 36‑1998) of 6 May 1998, together with its implementing Regulations (Government Decision No. 745‑99), make up Guatemala's main legislation on sanitary and phytosanitary measures and were not amended during the review period.[108] Both the Plant and Animal Health Law and its implementing Regulations provide that sanitary and phytosanitary (SPS) measures are established on the basis of an assessment of the actual risks involved

3.78.  The principal rules at the regional level can be found in the Central American Regulations on Sanitary and Phytosanitary Measures and Procedures of 17 September 1999, which apply to imports from other CACM countries. Guatemala recognizes the SPS measures of other countries as equivalent provided that they meet the necessary requirements, pursuant to Article 7 of Decree No. 36‑98. Furthermore, the MAGA may accept as equivalent the SPS measures applied in accordance with bilateral, regional or multilateral agreements signed by Guatemala, provided that they are based on technical and scientific evidence that can be proved; the necessary administrative procedure is defined in each case. The equivalence of SPS measures is not automatic but is recognized through a procedure designed to achieve the level of protection deemed satisfactory by Guatemala even though the SPS measures may be different

3.79.  The MAGA and the Ministry of Public Health and Social Welfare (MSPAS) have responsibility for applying the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. The MSPAS is entrusted with: enforcing sanitary technical regulations for processed food products, medicines and related products; granting import and export authorizations; certifying the quality and safety of products; and assessing compliance with the relevant regulations. It also has the task of conducting sanitary inspections. The MAGA is responsible for: the regulations on the safety of unprocessed natural foods; compliance with the regulations on animal and plant health; inspection and certification of plants and related products intended for export or domestic consumption; and verifying whether imported products comply with the sanitary and phytosanitary regulations.[109]

3.80.  In the previous Review it was indicated that all animal or plant products, irrespective of their origin, required an import permit. For the purposes of this Review, the authorities have stated that the situation has changed and that at present not all plant products require an import permit; this does not apply to those which present no risk for plant health or, because they have been processed, do not carry any disease for any country. Seeds do, however, need an import permit and, in addition, the importer must obtain a seed dealer's licence. The procedure takes place in the MAGA's Vice‑Ministry of Plant and Animal Health and Regulations (VISAR). For products of animal origin, COMIECO Resolution No. 338‑2014 determines three categories of risk: high (live animals and their products), medium (processed products such as cheese), and low (processed products such as yoghurt, sardines, etc.)

3.81.  An import permit is not required for low‑risk products coming from other Central American countries, which are simply inspected at random when entering Guatemala. For products from countries outside Central America, Article 24 of the Regulations implementing the Plant and Animal Health Law (Government Decision No. 745‑99)[110] applies in general terms. This means that, in principle, an import permit may be required for all animal or plant products, irrespective of their origin, although in practice this is often not the case. According to this Article, the import of plants, animals, their products and by‑products and inputs for agricultural and animal use must have a phytosanitary or animal health permit, as appropriate, as well as a permit for pesticides or a licence for fertilizers. This has to be requested from the competent division in the MAGA and must show the origin of the product. VISAR examines the requests submitted and has the authority to lay down requirements, restrictions or prohibitions on the total or partial import indicated in the request, in accordance with the analysis of the risk of pests and diseases and scientific evidence

3.82.  If it is sought to import plants, animals, their products or by‑products or inputs for agricultural or animal use coming from an area or country where there are diseases subject to quarantine or there is reasonable doubt concerning their plant or animal health status, the product is inspected in the country of origin or source, the cost being covered by the interested party and, if deemed necessary, a study analysing the risk of pests or disease will be required. Nevertheless, if the import or export of a product is in the national interest, the MAGA bears the cost of the risk analysis study

3.83.  The MAGA is Guatemala's national enquiry point for the purposes of the Agreement on the Application of Sanitary and Phytosanitary Measures. VISAR, within the MAGA, is responsible for forwarding all notifications to the sectors affected by sanitary and phytosanitary measures adopted by WTO Members. The notifications sent in by other WTO Members are circulated for information to all the organized groups concerned

3.84.  Guatemala is a member of the Codex Alimentarius Commission; its contact point for this body is VISAR's Food Safety Directorate, which also represents Guatemala at the World Organisation for Animal Health (OIE). Guatemala ratified the International Plant Protection Convention (IPPC) in 1955; its contact point is also VISAR's Food Safety Directorate

3.85.  The rules applicable to the safety of food imports are found in the Health Code (Decree No. 90‑97), Government Decision No. 969‑99, Government Decision No. 72‑2003, Ministerial Decision No. 14‑2013, Ministerial Decision No. 382‑2014, and COMIECO Resolution No. 271‑2011. The MAGA and the MSPAS are the competent authorities in this field. Pursuant to these Decisions, products which do not comply with the required standards are rejected or, if they present a risk for public health, are destroyed at the cost of the importer. Moreover, the MSPAS requires a valid registration certificate and, where applicable, a sanitary or phytosanitary permit issued by VISAR, showing that the products imported do not represent a risk for animal or plant health. The MAGA's decision must be based on scientific evidence. Government Decision No. 249‑2002 of the MSPAS contains the regulations on authorization and sanitary control of facilities providing prepared foods and non‑alcoholic beverages at markets, fairs and on the public highway.[111]

3.86.  The rules on recognition of testing procedures by the MAGA are contained in Ministerial Decision No. 1128‑2001. This Decision is currently been evaluated internally in the light of the MAGA's new operational structure. The Guatemalan authorities recognize the tests carried out and the certificates issued by other countries

3.87.  As already indicated, before marketing any food product with a trade name, an authorization has to be obtained from the Ministry of Public Health, together with sanitary reference registration or sanitary certification. The MSPAS keeps the Sanitary Reference Register, which is based on Central American regional regulations.[112] The requirements for sanitary reference registration are based on risk criteria. It guarantees the safety and quality of the food and constitutes the basic benchmark for regular control of the product on the market. The time needed for registration and the subsequent issue of a Sanitary Reference Register number to the user and the corresponding certification depends on the risk presented by the product: 30 days for products deemed to be high risk ("A") and seven days for low‑risk ("B") products. The cost of the sanitary registration procedure is Q 1,650 per product. Sanitary registration remains valid for five years. Unprocessed products, raw materials and food additives are exempt from registration

3.88.  The Food Regulation and Control Department (DRCA) in the MSPAS Directorate‑General of Health Regulation, Monitoring and Control also keeps a mandatory register of products for packaged foods entering Guatemala. The importer has to submit a certificate of free sale issued by the country of origin. The DRCA gives a sanitary registration number after conducting laboratory tests on the product. This registration number is valid for five years and the time taken to issue it also depends on the level of risk and the type of product. For products deemed to be of high risk such as beef or poultry meat, the time required for registration may be up to six weeks. For products that are deemed not to present any risk, the procedure takes around 72 hours. The formalities for authorizing food imports of may be completed through the MSPAS services window.[113]

3.89.  Pursuant to the Plant and Animal Health Law and its implementing Regulations, imports are inspected at the point of entry into Guatemala. The authorities in charge of inspection have handbooks that define the criteria for inspection and, where necessary, the taking of samples

3.90.  For a country or area to be declared free of a pest or disease or one of low prevalence, a technical and scientific report issued by the competent authority in the country declared free has to be submitted. This report must be sent to the MAGA, which then examines and reviews the documents in order to check that the information provided corresponds to the requisite documentation, or, in its absence, conducts an in situ analysis. If there is compliance with the international guidelines on declaring areas free or of low prevalence, the MAGA accepts the report

3.91.  The import of genetically modified products is not prohibited. Guatemala has legislation on the testing and production of genetically modified seeds for export in the form of Ministerial Decision No. 386‑2006, which lays down the requirements for their import, transport and handling within Guatemala, the conduct of field experiments and the production for export of live modified organisms for agricultural use.[114] Living modified organisms must also comply with the provisions in Decree No. 68‑86 (Law on the protection and improvement of the environment). By means of Decree No. 44‑2003, Guatemala has ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which governs the cross‑border movement of living modified organisms. During the review period, a national biosafety policy 2013‑2023 for living modified organisms was introduced (Government Decision No. 207‑2014), which provides the strategic framework to guide action for the development, use and safe application of living modified organisms. Its aim is to help ensure the protection of human health, the environment, biological diversity and sustainable use. In June 2016, a proposal on national biosafety regulations for living modified organisms was under consideration

3.92.  SPS drafts are drawn up by various authorities with competence for the different aspects of the regulations. Before being put up for approval and unless there is an emergency, the MAGA notifies the WTO of SPS drafts so that WTO Members can send in their remarks and comments within a period of 60 days. The most important SPS measures adopted by Guatemala between 2009 and 2015 are shown in Table A3.2. Over the same period and up to February 2016, Guatemala notified 18 sanitary and phytosanitary measures to the WTO.[115] The inventory or register of SPS measures and the legislation in force may be viewed on the MAGA's website at: http://www.maga.gob.gt

3.93.  Guatemala has two bilateral agreements on sanitary and phytosanitary measures, one with the United States and another with the Central American countries. The agreement with the United States is regulated by Ministerial Decision No. 340‑2006 (provisions on recognition of United States food safety measures for inspection schemes for unprocessed products of bovine, pig and poultry meat as equivalent). The agreement with Central America is regulated by COMIECO Resolution No. 80‑2001 (recognition of sanitary registration for processed foods produced in the Central American region)

3.62.  The National Quality System, created by Decree No. 78‑2005 (Law on the National Quality System) is responsible for promoting and coordinating standardization, metrology, accreditation, conformity assessment and technical regulation activities. By June 2016, the Regulations implementing the Law on the National Quality System had not yet been issued, although the authorities have indicated that a preliminary draft text is under preparation and is expected to be published shortly in the Official Journal

3.63.  The National Quality System is administered by the Directorate for the National Quality System. In 2004, Guatemala notified the WTO that it had accepted the Code of Good Practice for the Preparation, Adoption and Application of Standards, through the Foreign Trade Policy Directorate in the Vice‑Ministry of Integration and Foreign Trade, which is the Directorate responsible for notifying documents deemed relevant to Guatemala's WTO commitments.[103] In addition, the Directorate for the National Quality System participates in the Advisory Commission of the National Science and Technology Council (CONCYT) as an adviser on matters relating to quality, technology and competitiveness

3.64.  Pursuant to the relevant Law, Guatemala's National Quality System is composed of: the Guatemalan Standards Commission (COGUANOR), the National Metrology Centre (CENAME), the National Commission for Technical Regulations (CRETEC), the Guatemalan Accreditation Bureau (OGA), and the Information Centre (CEINFORMA). Guatemala belongs to the International Organization for Standardization (ISO), within which COGUANOR participates in the Committee on Developing Country Matters. Guatemala is also a full member of the Pan American Standards Commission (COPANT); CENAME is a member of the Inter‑American Metrology System (SIM); and the OGA is a member of Inter‑American Accreditation Cooperation (IAAC)

3.65.  COGUANOR is part of MINECO and is the national standardization body. It was created by Decree No. 1.523 of 1962 and its responsibilities were ratified by the Law on the National Quality System. It is the standardization body for all economic sectors and its goal is to boost products and services of quality.[104] It is responsible for drafting, publishing and disseminating Guatemalan technical standards (NTG), compliance with which is voluntary, as are their use and application, pursuant to the Law on the National Quality System. NTGs are prepared with support from all the sectors concerned (regulators, consumers and academia), which have a role in their examination and approval though technical committees. Although COGUANOR standards are voluntary, they can serve as the basis for preparation of a mandatory technical regulation on the part of a government authority

3.66.  Until 2005, COGUANOR was the body entrusted with drafting and adopting technical regulations and monitoring compliance. Since the Law on the National Quality System was published in 2005, responsibility for drawing up technical regulations has fallen on the government entity concerned, with assistance from CRETEC. Pursuant to the Law on the National Quality System, CRETEC is a consultative and advisory body for matters relating to technical regulations. The principal government authorities which draw up technical regulations are the Ministries of Public Health, Agriculture and Livestock, the Environment and Natural Resources, and Energy and Mining, inter alia. Technical regulations must be drawn up by Ministries and government institutions with the knowledge of CRETEC's Technical Secretariat so as to make it easier to inform production sectors and meet the notification requirements laid down in the trade agreements ratified by the Republic of Guatemala. In May 2016, preliminary draft regulations for CRETEC were under preparation, although CRETEC has been operating since June 2009 and its tasks include: ensuring that various government authorities, institutions, organizations and units comply with the WTO Agreements on Technical Barriers to Trade and on the Application of Sanitary and Phytosanitary Measures; ensuring that technical regulations are prepared on the basis of the provisions in a national, regional or international technical standard; recommending the amendment of technical regulations or draft technical regulations to bring them into line with the provisions of international organizations specializing in this sector; preventing the issue of technical regulations which unnecessarily duplicate provisions relating to the same product; keeping up to date the register of technical regulations in effect and the list of draft regulations; and ensuring that the bodies composing the National Quality System take action to ensure observance of technical regulations.[105]

3.67.  The Regulations for the integration and performance of the functions of the National Standardization Council, the National Accreditation Council, the National Metrology Council and CRETEC were enacted by means of Government Decision No. 149‑2009. By April 2016, however, the Regulations implementing the Law on the National Quality System had not yet been issued, although preliminary draft regulations were under preparation. Also pending is the decision by the Attorney General's Office on the draft regulations for COGUANOR certification, the draft list of fees for COGUANOR's services and the draft text updating the fees for CENAME's services, while the preliminary draft of the CRETEC Regulations and Handbook also awaits preparation

3.68.  Since 2005, responsibility for drafting national technical regulations has lain with the Ministry responsible for the sector to which the measure refers and both public and private bodies with an interest in the matter take part in the process. Central American technical regulations are agreed with the other Central American countries with a view to their approval and notification. Before being forwarded for approval, national and Central American technical regulations and draft technical regulations must be notified to the WTO by MINECO so that WTO Members may submit their remarks and comments within a period of 60 days. The special technical committee which prepared the draft technical regulation in question examines any comments received. National and Central American technical regulations must be published in the Official Journal within 30 days following approval and then enter into force eight days later

3.69.  Chart 3.2 outlines the procedures for the preparation of technical regulations at the Central American level

3.70.  There is no automatic mechanism for eliminating technical regulations that form part of mandatory Guatemalan standards (NGOs). Those that have become obsolete are abolished by means of a government decision repealing out‑of‑date regulations and replacing them, where appropriate, by updated regulations. Revision of technical regulations has to be requested by the interested party and they can only be eliminated by means of a government decision at the request of the interested party after COGUANOR has examined them, through its Executive Secretary

3.71.  The OGA, established by Government Decision No. 145‑2002, published on 6 May 2002, as amended by Decree No. 78‑2005, is the entity responsible for accreditation and its administration in Guatemala for the purpose of formally recognizing the technical competence of conformity assessment bodies, based on the international or national standards in effect.[106] The bodies subject to assessment by the OGA are: testing and calibration laboratories (COGUANOR standard NTG ISO/IEC 17.025); clinical analysis laboratories (COGUANOR standard NGT ISO 15.189); and inspection bodies (COGUANOR standard NTG ISO/IEC 17.020). It may also assess management system certification bodies (ISO/IEC standard 17.021), as well as product certification bodies (ISO/IEC standard 17.065) and personnel certification bodies (ISO standard 17.024). By March 2016, the OGA had accredited 35 organizations broken down as follows: 25 testing laboratories, three calibration laboratories, five clinical laboratories and two inspection bodies. By May 2016, no certification body had been accredited, although the accreditation of two product certification bodies accredited by a European organization that had signed mutual recognition agreements has been recognized

3.72.  CENAME is composed of the National Metrology Laboratory and the Legal Metrology Inspection and Verification Unit. The National Metrology Laboratory provides calibration services in relation to mass, temperature, volume, dimension, electricity and pressure; the Legal Metrology Inspection and Verification Unit is involved in the inspection of fossil fuel dispensers nationwide in cooperation with the Ministry of Energy and Mining (MEM) and the Directorate of Consumer Affairs (DIACO). There are also the Laboratory for the Inspection of Drinking Water Meters and the Laboratory for the Inspection of Electricity Meters. CENAME takes part in: COGUANOR's technical standardization committee in relation to the updating and national approval of metrology standards; the OGA's technical accreditation committee in relation to the definition of assessment criteria for calibration and testing laboratories in order to obtain international recognition for their conformity assessment activities; and CONCYT's quality commission to develop metrological quality in science and technology projects in order to raise the level of Guatemala's competitiveness

3.73.  During the period under review, CRETEC compiled an inventory of national and regional technical regulations: as of April 2016, this included 463 national technical regulations, together with 62 Central American technical regulations. CRETEC has also prepared a Handbook of Good Technical Regulation Practices. Between 2009 and April 2016, Guatemala made 35 notifications to the WTO Committee on Technical Barriers to Trade, most of which concerned draft regulations prepared by the Ministries of the Economy, Agriculture and Public Health. These 35 technical regulations were approved

3.74.  During the review period, 40 Central American technical regulations were approved. As of March 2016, 863 standards and technical regulations were in effect concerning areas such as: standardization, metrology and social sciences; general science; medicine; materials testing; pipes and flanges, valves and accessories and various means for distributing fluids and irrigation; motor vehicle materials; sanitary engineering; chemical industries; powders and explosives; fermentation industries; agricultural and food industries; fishing industries; iron and steel industry; building industries; architecture; agriculture and agricultural machinery; various industries; packaging; documentation; petroleum products; plastics and rubber; leather, footwear and related industries; quality management; secure storage units; exploitation of electric power lines; information technology; the environment; refrigeration; ethics; leisure, recreational and active tourism services; geographical information; glass industry; household electrical appliances; climate change and energy efficiency.[107] Over the review period, from 2009 to March 2016, COGUANOR published 253 technical standards. No detailed information is available on the technical regulations prepared by other bodies

3.75.  All the free trade agreements signed by Guatemala contain a chapter on technical barriers to trade which include provisions on technical regulations and conformity assessment procedures, while the partial scope agreements, although they do not include a TBT chapter, do contain articles on technical regulations and conformity assessment procedures. The CAFTA‑DR contains provisions on standards, technical regulations and conformity assessment procedures. Article 7.6 thereof provides for acceptance of trading partners' regulations as equivalent. At the Central American level, the registration and approval of a large number of technical regulations are recognized. During the review period, three mutual recognition agreements were signed, through the Guatemalan Accreditation Bureau of the MINECO National Quality System, in the IAAC and International Laboratory Accreditation Cooperation (ILAC) context: in 2008, to accredit testing laboratories, including those carrying out clinical analyses; in 2012, the agreement on recognition was extended to calibration laboratories; and in 2013, the accreditation of inspection bodies was added. Under these agreements, reviews, reports or certificates issued by the laboratories and inspection bodies accredited by the OGA in Guatemala are recognized at the international level

3.76.  Guatemala has a number of labelling regulations for certain products. According to Government Decision No. 969‑99 on food safety, all processed or packaged foods for public consumption must be labelled in accordance with Guatemala's technical regulations. The main regulation in this respect is the COGUANOR technical regulation on the labelling of packaged food products for human consumption (NGO 34039). If there are no relevant national regulations, the Codex Alimentarius and other international standards apply. Producers and importers of processed foods are responsible for ensuring that the labelling is correct. Pursuant to Article 135 of the Health Code (Decree No. 90‑97) of 2 October 1997, the content and composition of all food products, as well as special health indications, must appear on the labels in Spanish. According to Article 36 of the Food Safety Regulations (Government Decision No. 969‑99), however, unprocessed natural foods, raw materials and food additives are exempt from the labelling requirement. Guatemala currently has Central American technical regulations on labelling for: food and beverages; medicines; distilled alcoholic beverages; fermented alcoholic beverages; footwear; textiles and clothing; pesticides for domestic use; formulated synthetic pesticides; fertilizers and soil improvers for agricultural use; cosmetics; and cleaning products