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市場調查報告書

巴西的農藥法規情形:2017年

Agrow Agrochemical Regulatory Situation Brazil 2017

出版商 AGROW 商品編碼 585199
出版日期 內容資訊 英文 98 Pages
商品交期: 最快1-2個工作天內
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巴西的農藥法規情形:2017年 Agrow Agrochemical Regulatory Situation Brazil 2017
出版日期: 2017年11月07日 內容資訊: 英文 98 Pages
簡介

巴西的農藥市場規模估計為100億美元。巴西是全球最大的農作物生產國、出口國之一。

本報告提供巴西的農藥法規相關情況調查,巴西的農業情形,農藥的目前利用、市場,農藥登記系統,對登記必要的資料,及登記障礙等相關彙整。

摘要整理

第1章 簡介

第2章 巴西的農業、農藥市場

  • 摘要
  • 簡介
  • 地區
    • 中部、中西部
    • 東北部
    • 北部
    • 東南部
    • 南部
  • 作物
    • 大豆
    • 玉米
    • 甘蔗
    • 咖啡
    • 豆類、米
    • 其他作物
  • 農產品出口
  • 巴西的農藥市場
    • 基因轉殖作物
    • 農藥的進口

第3章 農藥的登記準確度

  • 摘要
  • 簡介
  • 登記機關
  • 登記機關的責任
  • 毒物分類
  • 登記的一般特徵

第4章 對農藥登記必要的資料

  • 摘要
  • 巴西的法律的層級
  • 用語、定義
  • 各種登記的資料必要條件
  • 農作物保護產品的登記的修正
  • 登記禁止

第5章 最新活動、未來趨勢

  • 摘要
  • 簡介
  • 小型的作物
  • 對蜂的擔憂
  • 登記的優先順序
  • 產品
  • 登記的障礙
  • 登記認證
  • 為改善巴西的登記制度的降低

附錄

目錄
Product Code: 87545

This unique report is fundamental reading for those interested in discovering the regulation and registration processes for pesticides in Brazil.

Brazil's pesticide market is estimated at US$10 billion. Brazil is one of the largest producers and exporters of agricultural crops in the world, planting various tropical and temperate fruits, vegetables and grains. The tropical environment results in many pest and disease problems and requires extensive use of pesticides to maintain productivity. There are calls for the system to be modernized and some steps have been taken towards this.

Key Insights:

  • Brazil's agricultural status
  • Current use and market of pesticides
  • The pesticide registration system
  • Data requirements for registration
  • Registration bottlenecks

Table of Contents

Contents

Abbreviations

Executive summary

Chapter 1: Introduction

Chapter 2: Brazilian agriculture and the pesticide market

  • 2.1. Summary
  • 2.2. Introduction
  • 2.3. Geography
    • 2.3.1. Centre or Mid-West
    • 2.3.2. Northeast
    • 2.3.3. North
    • 2.3.4. Southeast
    • 2.3.5. South
  • 2.4. Crops
    • 2.4.1. Soybeans
    • 2.4.2. Maize
    • 2.4.3. Sugar Cane
    • 2.4.4. Cotton
    • 2.4.5. Coffee
    • 2.4.6. Beans and rice
    • 2.4.7. Other crops
  • 2.5. Agricultural exports
  • 2.6. The Brazil pesticide market
    • 2.6.1. Transgenic crops
    • 2.6.2. Pesticide imports

Chapter 3: The registration system for pesticides

  • 3.1. Summary
  • 3.2. Introduction
    • 3.2.1. The agronomic prescription
  • 3.3. The registration agencies
    • 3.3.1. MAPA
    • 3.3.2. Anvisa
    • 3.3.3. Ibama
  • 3.4. Responsibilities of the registration agencies
  • 3.5. Toxicological classifications
    • 3.5.1. Anvisa
    • 3.5.2. Ibama
      • 3.5.2.1. Environmental risk potential (PPA)
      • 3.5.2.2. Environmental risk evaluation (ARA)
  • 3.6. General characteristics of registration
    • 3.6.1. The RET
    • 3.6.2. Other registrations
    • 3.6.3. Maintaining documentation up-to-date
    • 3.6.4. MAPA protocols
    • 3.6.5. Registration procedure
      • 3.6.5.1. Publication in the official gazette
      • 3.6.5.2. Distribution of registration submissions
      • 3.6.5.3. Technical analysis
      • 3.6.5.4. Notification of Requirements
      • 3.6.5.5. Irregularities and rejection of the submission
      • 3.6.5.6. Report on agronomic efficiency and feasibility
      • 3.6.5.7. Final consolidation

Chapter 4: Data requirements for Brazilian registrations

  • 4.1. Summary
  • 4.2. Hierarchy of laws in Brazil
  • 4.3. Terminology and definitions
  • 4.4. Data requirements for different registrations
    • 4.4.1. Special temporary registration for research and experimentation (RET)
      • 4.4.1.1. Research and experimentation
      • 4.4.1.2. Types of RET
    • 4.4.2. Registration of technical product
    • 4.4.3. Registration of me-too technical product
    • 4.4.4. Registration of a pre-mixture
    • 4.4.5. Registration of a formulated product
      • 4.4.5.1. Product clones
      • 4.4.5.2. Atypical products
    • 4.4.6. Registration of a me-too formulated product
    • 4.4.7. Registration of a biological product
    • 4.4.8. Registration of a microbiological product
    • 4.4.9. Registration of a semiochemical product
    • 4.4.10. Registration of a formulated biochemical product
    • 4.4.11. Registration of a domissanitary product
      • 4.4.11.1. Registration of insecticides
      • 4.4.11.2. Registration of rodenticides
      • 4.4.11.3. Packaging and labelling
    • 4.4.12. Registration of products for organic agriculture
      • 4.4.12.1. Establishment of a reference specification
      • 4.4.12.2. Registration process for organic agriculture
  • 4.5. Alterations in the registrations of crop protection products
    • 4.5.1. Technical alterations requested only by MAPA
    • 4.5.2. Exclusions
    • 4.5.3. Inclusions
    • 4.5.4. Limitations in use
    • 4.5.5. New company name and tax number
    • 4.5.6. Alteration in address
    • 4.5.7. Transfer of title
    • 4.5.8. Alteration in brand name
    • 4.5.9. New labels
    • 4.5.10. Inclusion of third-party importer
    • 4.5.11. Technical alterations
    • 4.5.12. Inclusion of formulator and/or manipulator for formulated product
      • 4.5.12.1. Inclusion of the manufacturer of technical product
    • 4.5.12. Inclusion of the manufacturer of the technical product in the registration of the formulated product
      • 4.5.12.3. Inclusion of the manufacturer of the third-party technical product registration in the registration of the formulated product
      • 4.5.12.4. Alteration in the localization of the manufacturing unit
      • 4.5.12.5. Establishment of dosages higher than those registered, increase in application frequency, inclusion of application use, inclusion of crop in product already registered
      • 4.5.12.6. Alteration in the production process of the TP
      • 4.5.12.7. Recommendation of tank mix
      • 4.5.12.8. Alteration in formulation components
      • 4.5.12.9. Inclusion of aerial application
      • 4.5.12.10. Alteration of toxicological classification, safety interval and MRLs, environmental classification and packaging with a different material and volume to that approved
      • 4.5.12.11. Alterations in labels and product insert
  • 4.6. Registration prohibitions

Chapter 5: Recent events and future trends

  • 5.1. Summary
  • 5.2. Introduction
  • 5.3. Minor crops
  • 5.4. Bee concerns
  • 5.5. Registration priorities
    • 5.5.1. Biological products
    • 5.5.2. The approval process
    • 5.5.3. Establishing priorities
    • 5.5.4. Anvisa public consultations
    • 5.5.5. Priorities for 2017
  • 5.6. Product suspensions
    • 5.6.1. Soybean rust fungicides
    • 5.6.2. Paraquat phase-out
  • 5.7. Registration bottlenecks
  • 5.8. Registration approvals
  • 5.9. Recommendations to improve Brazil's registration system

Appendix 1: Site links of Brazilian pesticide legislation

Appendix 2: The toxicological classification of pesticide products according to Anvisa guidelines

List of Figures

  • Figure 1: Map of Brazil showing main geographic regions
  • Figure 3.1: Organogram of MAPA
  • Figure 3.2: Organogram of Anvisa
  • Figure 3.3: Structural organization of GGTOX, Anvisa
  • Figure 4.1: Typical flowchart of pesticide registration in Brazil
  • Figure 4.2: Registration flowchart of crop protection products for organic agriculture

List of Tables

  • Table 2.1: Use and availability of land in Brazil
  • Table 2.2: Principal crops grown in Brazil in 2016/2017
  • Table 2.3: Brazilian agribusiness exports in 2016
  • Table 2.4: Brazil ranking in agricultural production and exports in 2014-15
  • Table 2.5: Sales of pesticides in different crops in Brazil in 2016
  • Table 2.6: Sales of different classes of pesticides in Brazil in 2016
  • Table 2.7: Sales of pesticides in Brazil by state in 2016
  • Table 2.8: Pesticides imported by Brazil in 2016
  • Table 4.1: Data requirements for registering a technical product
  • Table 4.2: Data requirements for registering a me-too technical product
  • Table 4.3: Data requirements for registering a chemical formulated product
  • Table 4.4: Data requirements for registering a me-too formulated product based on a me-too technical product
  • Table 4.5: Data requirements for registering a biological control agent
  • Table 4.6: Necessary information for Anvisa and Ibama for the evaluation and registration of biological control agents
  • Table 4.7: Data requirements for registering a microbiological product
  • Table 4.8: Data requirements for registering a semiochemical product
  • Table 4.9: Data requirements for registering a formulated biochemical product
  • Table 4.10: Data requirements for registering a domissanitary product
  • Table 4.11: Toxicological data necessary for evaluating AIs not authorized by Anvisa
  • Table 4.12: The process of risk evaluation for domissanitary products
  • Table 4.13: List of prohibited and restricted use AIs for domissanitary products
  • Table 4.14: Maximum content permitted in individual packaging of domissanitary OTC products
  • Table 4.15: Data requirements for registering a crop protection product for organic agriculture
  • Table 5: Summary of registrations granted in Brazil for the period 2005-17
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