3.128.  There have been no major changes to the legal and institutional frameworks for sanitary and phytosanitary (SPS) protection since Brazil's previous Review.[314] MAPA, through its Secretariat of Animal and Plant Health and Inspection (SDA), remains in charge of SPS measures related to animal and plant health. ANVISA, an autonomous body, retains regulation and surveillance responsibilities for the protection of human health, including the setting of maximum residue levels of pesticides.[315] The National Technical Commission on Biosafety (CTNBio), a multidisciplinary advisory body to the Federal Government, remains Brazil's authority for all activities involving genetically modified organisms (GMOs). ANVISA and MAPA continue sharing regulatory and surveillance competences over certain vegetable products

3.129.  Brazil's enquiry points and notification authority for SPS matters have not changed since its last Review.[316] Between January 2017 and May 2022, Brazil submitted to the WTO 1,155 notifications, including 2 emergency and 834 regular. Approximately 14% of the measures announced in regular notifications allowed for a comment period of at least 60 days, and 11% were based on international standards. Over the same period, Brazil was asked to respond to one newly raised specific trade concern at the Committee on Sanitary and Phytosanitary Measures.[317]

3.130.  Competence for the adoption of SPS measures remains vested in ANVISA and MAPA. The authorities indicate that there have been no major changes to either entity's adoption procedures since Brazil's last Review.[318] A non-automatic licensing system remains in place for imports subject to SPS controls. The importation of some of these goods may also require prior authorization, certification (for unrestricted commercialization or quality), and/or inscription in a register

3.131.  In general, SPS controls for exports from Brazil include registration and accreditation of the producer and certification of the exported good. Product-specific import and export formalities (including phytosanitary, quality, and identity requirements) can be consulted and fulfilled through Siscomex

3.132.  The prerequisites for the importation of products of animal (including aquatic animal) origin into Brazil include assessment or recognition of the exporting country's sanitary inspection systems as equivalent to Brazil's, accreditation of the exporting establishments, and approval of each establishment's products and labels.[319] Each shipment to Brazil must be accompanied by a sanitary certificate issued by the exporting country's competent authorities, and carry approved labels or stamps. Imports of animal products and their sub-products may be physically inspected at the port of entry, with samples taken for laboratory testing whenever necessary, depending on the foreign establishment's compliance record.[320]

3.133.  Imports of plants and plant products are subject to documentary and inspection requirements that vary according to the product's intended use and its classification in one of five risk categories. Plant products commercialized in Brazil, including imports, must comply with quality‑related characteristics (e.g. size, purity, and maturity) laid out in the Brazilian classification system, whenever a specific standard to that effect is in place; the classification of imported plant products is done by MAPA.[321] The importation of seeds for commercial purposes is strictly limited to the species and varieties contained in the National Register of Plant Varieties (RNC) maintained by MAPA.[322] The conformity of imports is verified at the border, either by the SDA or by accredited private companies.[323]

3.134.  Importers of controlled foodstuffs must obtain an authorization from ANVISA and a licence from a state or municipal sanitary authority; the licence serves as an authorization from the National Sanitary Surveillance System and is valid throughout Brazil. Some of these products can only be imported after inscription in ANVISA's sanitary register.[324]

3.135.  Brazil maintains an Importation Alert Regime (RAI) targeting foreign establishments whose shipments of edible animal products have been found to be non-compliant with Brazilian SPS requirements. Whenever an irregularity is detected and an alert is issued, the overseas establishment's subsequent shipments (at least 10) of the same product are subject to 100% physical inspections and laboratory testing. Repeated irregularities of the same nature would trigger suspension of the establishment's licence to export to Brazil. Shipments of goods produced and certified after the suspension date will not be allowed to enter Brazil, even though importation may have already been authorized. If no sufficient evidence of corrective measures taken is received 90 days after notification of the exporting country's competent authorities, the SDA may revoke the establishment's accreditation. In case of recurrent serious irregularities, the SDA may suspend the accreditation of all similar establishments from that country or of the entire country

3.136.  Whenever required by the destination jurisdiction, Brazilian-based exporters of products of animal origin must obtain accreditation (habilitação) for their target market, conditional on a favourable official opinion (parecer official) by the SDA as to the applicant's documentary conformity and capacity to comply with any market-specific SPS requirements. A sanitary certificate must also be obtained from the SDA for each export shipment

3.137.  Brazil prohibits the commercialization, including imports and exports, of hormonal substances with anabolic characteristics, unless intended for therapeutic or research use.[325] The use of substances with anabolic hormonal properties for the purpose of promoting growth and weight in bovines and poultry destined for slaughter is banned.[326]

3.115.  Brazil's institutional framework for the implementation and administration of the TBT Agreement has remained broadly unchanged since its previous Review.[302] The National Institute of Metrology, Quality and Technology (INMETRO) continues serving as the executive secretariat of the National Council of Metrology, Standardization and Industrial Quality (CONMETRO); the coordinator of the Brazilian Network of Legal Metrology and Quality (RBMLQ-I); the regulatory and supervising authority for legal metrology and compulsory conformity assessment in the areas of security, environmental, and health protection, and prevention of deceptive trade practices; and the national enquiry point and notification authority under the TBT Agreement. INMETRO also represents Brazil at the Inter‑American Accreditation Cooperation, the International Accreditation Forum, the International Laboratory Accreditation Cooperation, the International Bureau of Weights and Measures, the International Organization of Legal Metrology, and in relevant initiatives within MERCOSUR, LAIA, and the Organization of American States

3.116.  The Brazilian Association for Technical Standardization (ABNT) remains in charge of coordinating the consensus-based development of Brazilian standards, and represents Brazil in the ISO/IEC and in regional normalization forums. Besides CONMETRO and INMETRO, some 31 federal agencies are responsible for issuing technical regulations and determining conformity assessment systems in their respective areas of competence. Any of these competent agencies may request that INMETRO coordinate conformity assessment activities for a particular technical regulation

3.117.  The marketing of products and services, which are both under INMETRO's authority and subject to compulsory conformity assessment, remains conditional on inscription in INMETRO's Register of items.[303] In addition, importers of products regulated by INMETRO must apply for an import licence through Siscomex and request its analysis for approval at INMETRO.[304] Other regulatory agencies, such as ANVISA, MAPA, and ANATEL, also have competence to require inscription in their respective registers. Pharmaceutical raw materials can only be imported by companies holding an authorization to operate in Brazil, issued by ANVISA

3.118.  In accordance with the Economic Freedom Rights legislation (Section 2.4.1), INMETRO has been modernizing its regulatory approval methods with a view to cutting red tape and simplifying rules. Tacit approval timelines for certain INMETRO decisions entered into force on 1 February 2020 (Table 3.15). In addition, as from July 2020, interested parties may request the revision of outdated technical regulations that depart from international standards.[305] In September 2020, INMETRO also put in place a three‑level risk assessment system for legal metrology and compulsory conformity assessment activities.[306] In February 2022, INMETRO formally adopted a new regulatory model, which was the result of extensive analysis and public consultations.[307]

3.119.  Brazil's modalities for elaboration, adoption and revision of standards, technical regulations, and conformity assessment procedures have not changed significantly since its previous Review.[308] Nevertheless, initiatives aimed at improving MERCOSUR's regulatory environment brought about updated procedures for elaboration, revision, and repeal of MERCOSUR technical regulations and for carrying out MERCOSUR conformity assessments[309], as well as a MERCOSUR Agreement on Good Regulatory Practices and Regulatory Coherence and a General Framework for Trade Facilitating Initiatives Within MERCOSUR.[310]

3.120.  Brazil's approach to granting equivalence remains based on the acceptance of some conformity assessment outcomes, including test results and audit reports, without explicit recognition of foreign technical regulations. Brazil did not notify to the WTO any plurilateral or bilateral agreements on TBT matters during the review period. Through INMETRO, Brazil is a party to some 120 TBT‑related technical cooperation instruments, of which 89 (including 19 in the field of accreditation) are currently in force

3.121.  At the national level, CONMETRO's non-binding Guide on Good Regulatory Practices continues to frame the elaboration, dissemination, periodic review, and elimination of technical regulations and conformity assessment procedures. Technical regulations may be established through laws, decrees, ordinances, normative instructions, or resolutions, and should be published in the Official Gazette. A period of six months is typically allowed between the publication of a measure and its entry into force. Ministries and agencies with authority to elaborate and issue technical regulations may do so ex officio or at the request of a third party. The holding of public consultations is generally required, except in exceptional cases. The authorities indicate that most technical regulations enacted in Brazil are based on international standards or MERCOSUR regional standards; when this is not the case, they are based on performance criteria. The recommended period for review and revision of technical regulations is five years

3.122.  Generally, the process for adopting conformity assessment procedures is similar to the one for technical regulations. Conformity assessment may involve certification, performance verification, sampling, labelling, inspection, and a conformity declaration by the supplier; certain activities (e.g. certification) may be delegated to accredited third parties. The supplier's declaration of conformity is an admissible instrument only for products or services of low to medium risk to human health and safety. In general, labelling requirements relate to the products' quality, quantity, composition, guarantee, shelf life, origin, and risks to consumer health and safety. All labels must bear this information in Portuguese and indicate the brand or name of the manufacturer

3.123.  The ABNT coordinates the consensus-based development of Brazilian standards, and represents Brazil in international and regional standardization forums (ISO, IEC, and MERCOSUR Standardization Association (AMN)). The ABNT accepted the Code of Good Practice for the Preparation, Adoption and Application of Standards (Annex 3 of the TBT Agreement) in 1995.[311] Standardization work is carried out by approximately 150 technical committees. Draft standards undergo a process of public consultations for 30 days. Once a technical consensus is reached, the standard is published by the ABNT. Standards older than five years are reviewed to ensure that they remain up to date. Brazilian standards may be used as base reference for technical regulations adopted by INMETRO

3.124.  As at May 2022, there were 8,934 standards in force in Brazil. Between January 2017 and May 2022, Brazil published 3,093 new standards, some 41% of which were adoptions of international (ISO/IEC) standards. As at 31 May 2022, INMETRO applied the following 132 compulsory conformity assessment procedures: certification (90 products and 8 services); conformity declaration by the supplier (16 products and 10 services); inspection (7 products); and audit (1 process). Additional compulsory conformity assessment procedures are administered by other competent entities, such as the Brazilian Health Regulatory Agency (ANVISA), the National Telecommunications Agency ANATEL, and MAPA. Information on conformity assessment measures affecting imports is made available in Siscomex (Section 3.1.1.)

3.125.  Between January 2017 and May 2022, Brazil made 1,446 notifications to the WTO TBT Committee, of which 689 were regular notifications mostly made under Article 2.9 of the TBT Agreement. For 74 regular notifications (11% of all regular notifications made), the timeliness of the submission allowed for a comment period of 60 days or more. Over the same period, Brazil was asked to respond to six newly raised specific trade concerns at the TBT Committee.[312]

3.126.  INMETRO's General Coordination of Accreditation (CGCRE) remains Brazil's national accreditation body in the field of conformity assessment.[313] It accredits entities engaging in certification, inspection, calibration, and testing. According to the authorities, entities seeking accreditation to carry out compulsory conformity assessment activities are generally not required to have a permanent office in Brazil, but a few technical regulations stipulate it as a prerequisite

3.127.  As at 31 May 2022, 493 calibration laboratories and 1,274 testing laboratories were accredited in Brazil, down from 382 and 1,046, respectively, in January 2017. There were also 1,176 entities with active accreditations to perform conformity assessments (certification, inspection, and performance verification), up from 879 in January 2017. Among the Brazilian‑accredited entities, five laboratories were located overseas