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ブラジルにおける農薬規制状況:2017年

Agrow Agrochemical Regulatory Situation Brazil 2017

発行 AGROW 商品コード 585199
出版日 ページ情報 英文 98 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=111.53円で換算しております。
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ブラジルにおける農薬規制状況:2017年 Agrow Agrochemical Regulatory Situation Brazil 2017
出版日: 2017年11月07日 ページ情報: 英文 98 Pages
概要

ブラジルの農薬市場規模は100億米ドルと推計されています。ブラジルは世界における最大の農作物生産国・輸出国のひとつです。

当レポートでは、ブラジルにおける農薬規制状況について調査し、ブラジルの農業状況、農薬の現在の利用・市場、農薬登録システム、登録に必要なデータ、および登録障壁などについてまとめています。

エグゼクティブサマリー

第1章 イントロダクション

第2章 ブラジルの農業・農薬市場

  • サマリー
  • イントロダクション
  • 地域
    • 中部・中西部
    • 北東部
    • 北部
    • 南東部
    • 南部
  • 作物
    • 大豆
    • トウモロコシ
    • サトウキビ
    • 綿
    • コーヒー
    • 豆類・米
    • その他の作物
  • 農産物輸出
  • ブラジルの農薬市場
    • トランスジェニック作物
    • 農薬の輸入

第3章 農薬の登録精度

  • サマリー
  • イントロダクション
  • 登録機関
  • 登録機関の責任
  • 毒物分類
  • 登録の一般的な特徴

第4章 農薬登録に必要なデータ

  • サマリー
  • ブラジルにおける法律のヒエラルギー
  • 用語・定義
  • 各種登録のデータ要件
  • 作物保護製品の登録における修正
  • 登録差し止め

第5章 最新イベント・将来の動向

  • サマリー
  • イントロダクション
  • マイナーな作物
  • 蜂に対する懸念
  • 登録の優先順位
  • 製品
  • 登録の障害
  • 登録認可
  • ブラジルの登録制度の改善のための低減

付録

目次
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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