RESEARCH REPORT (relatório de pesquisa) PROJECT BRAZIL- ARGENTINA ON REGULATORY CONVERGENCE: Regulatory convergence in Brazil-Argentina integration: technical, sanitary, phytosanitary and environmental measures and their supporting standards Product 5: Final document consolidating the results, information and analysis obtained in previous steps; policy indications Coordination: Prof. Dr. Vera Thorstensen Researchers: Mauro Kiithi Arima Jr Tiago Matsuoka Megale Patrícia Alencar Silva Mello Maruska Ferreira de Aguiar Lucas da Silva Tasquetto Thiago Rodrigues São Marcos Nogueira Anna Caroline Nunes Cortellini This research report was developed with resources from the Institute of Applied Economic Research (IPEA) and resulted from the Terms of Reference titled 18-Economic Commission for Latin America and the Caribbean-95059-Consultant, under the ECLAC-IPEA Technical Cooperation Agreement. 2 REGULATORY CONVERGENCE IN BRAZIL-ARGENTINA INTEGRATION: TECHNICAL, SANITARY, PHYTOSANITARY AND ENVIRONMENTAL MEASURES AND THEIR SUPPORTING STANDARDS PRODUCT 5: FINAL DOCUMENT CONSOLIDATING THE RESULTS, INFORMATION AND ANALYSIS OBTAINED IN PREVIOUS STEPS; POLICY INDICATIONS Coordination: Prof. Dr. Vera Thorstensen Researchers: Mauro Kiithi Arima Jr Tiago Matsuoka Megale Patrícia Alencar Silva Mello Maruska Ferreira de Aguiar Lucas da Silva Tasquetto Thiago Rodrigues São Marcos Nogueira Anna Caroline Nunes Cortellini This research report was developed with resources from the Institute of Applied Economic Research (IPEA) and resulted from the Terms of Reference titled 18-Economic Commission for Latin America and the Caribbean-95059-Consultant, under the ECLAC-IPEA Technical Cooperation Agreement. Product 5: Final document consolidating the results, information and analysis obtained in previous steps; policy indications 3 TABLE OF CONTENTS LIST OF TABLES AND FIGURES ............................................................................................................ 5 LIST OF ABBREVIATIONS ...................................................................................................................... 8 EXECUTIVE SUMMARY AND MAIN CONCLUSIONS ...................................................................... 10 1. OVERVIEW OF BRAZIL-ARGENTINA TECHNICAL REGULATORY SYSTEMS: ..................... 35 MAPPING OF REGULATIONS, TECHNICAL STANDARDS, MANDATORY CONFORMITY ASSESSMENT PROCEDURES APPLICABLE TO PRIORITY SECTORS ........................................... 35 1.1. Introduction .................................................................................................................................... 35 1.2. Technical Regulation System ......................................................................................................... 36 1.2.1. Technical Regulation in Brazil................................................................................................ 36 1.2.2. Technical Regulation in Argentina ......................................................................................... 38 1.2.3. Brazil and Argentina technical regulation: comparison based on notifications to TBT Committee ......................................................................................................................................... 40 1.3. Technical Standard Framework ...................................................................................................... 41 1.3.1. Technical Standards in Brazil ................................................................................................. 41 1.3.2. Technical Standards in Argentina ........................................................................................... 43 1.3.3. Brazil and Argentina technical standards: caparison based on standards produced by the main standardization bodies ....................................................................................................................... 45 1.4. Conformity Assessment System ..................................................................................................... 48 1.4.1. Conformity Assessment in Brazil ........................................................................................... 49 1.4.2. Conformity Assessment in Argentina ..................................................................................... 50 1.4.3. Brazil and Argentina conformity assessment procedures: comparison based on certification bodies ................................................................................................................................................ 53 1.5. Regional Regulatory Cooperation .................................................................................................. 54 1.5.1. Regulatory Cooperation in ALADI ......................................................................................... 54 1.5.2. Regulatory Cooperation in Mercosul ...................................................................................... 56 Source: Mercosur. Elaborated by CCGI-EESP/FGV. ........................................................................... 58 2. VEHICLES AND AUTO-PARTS ......................................................................................................... 63 2.1. Vehicles and auto parts (Brazil) ...................................................................................................... 63 2.1.1. Overview ................................................................................................................................. 63 2.1.2. Mapping technical regulation .................................................................................................. 65 2.1.3. Mapping technical standards ................................................................................................... 66 2.1.4. Mandatory conformity assessment procedures ....................................................................... 67 2.2. Vehicles and auto parts (Argentina) ............................................................................................... 68 2.2.1. Overview ................................................................................................................................. 68 2.2.2. Mapping of regulations ........................................................................................................... 69 2.2.3. Mapping Technical Standards ................................................................................................. 70 2.2.4. Mandatory conformity assessment procedures ....................................................................... 71 3. MACHINERY ........................................................................................................................................ 74 3.1. Machinery (Brazil).......................................................................................................................... 74 3.2. Machinery (Argentina) ................................................................................................................... 77 3.2.1. Overview ................................................................................................................................. 77 5.2.2. Mapping Technical Regulation and Main Regulatory Authorities ......................................... 78 3.2.3. Mapping Technical Standards ................................................................................................. 80 3.2.4. Mandatory conformity assessment procedures ....................................................................... 81 4. ELECTRICAL APPLIANCES............................................................................................................... 83 4.1. Electrical Appliances (Brazil) ......................................................................................................... 83 4.1.1. Overview ................................................................................................................................. 83 4.1.2. Mapping of technical regulation ............................................................................................. 83 4.1.3. Mapping of technical standards .............................................................................................. 84 4.1.4. Mandatory conformity assessment procedures ....................................................................... 85 4.2. Electrical Appliances (Argentina)................................................................................................... 86 4.2.2. Mapping of technical regulations ............................................................................................ 88 4.2.3. Technical Standards ................................................................................................................ 89 4.2.4. Mandatory conformity assessment procedures ....................................................................... 89 5. MEDICAL DEVICES ............................................................................................................................ 91 5.1. Medical Devices (Brazil) ................................................................................................................ 91 5.1.1. Overview ................................................................................................................................. 91 Product 5: Final document consolidating the results, information and analysis obtained in previous steps; policy indications 4 5.1.2. Mapping Technical