Agrochemical Regulatory Situation Brazil 2017

  • ID: 4433309
  • Report
  • Region: Brazil
  • 98 Pages
  • Agrow
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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.
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  • 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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