2. BRAZILIAN SYSTEM
• MAPA – Agriculture Ministry responsible for evaluation of
Efficacy based on Field Studies
• ANVISA – Health Ministry responsible for Toxicological
evaluation of products
• IBAMA – Environmental Ministry responsible for
Ecotoxicological and Envrionmental Contamination
evaluation
• CTA – all (MAPA, ANVISA, IBAMA) responsible for
evaluation of EQUIVALENCE of Technical Product
3. STEPS OF REGISTRATION
• 1. RET (Temporary Registration) – Necessary for all
laboratory or Field studies in Brazil (its not possible to
import samples before this) – Time involved 1 - 3 months
• 2. Laboratory and Field Studies – Time involved 6 – 24
months (dependig harvest)
• 3. Registration of Technical Product – Until now 18-24
months
• 4. Registration of all ingredients of the formulation
• 5. Registration of Formulated Product – Until now 18-
24 months – Equivalence 6-8 months after PT evaluation
• 6. Registration in States where the product will be sell
5. LABORATORY ANALYSIS
• Five batch analysis
• Vapour Pressure
• Boiling/Melting point
• Solubility
• N-octanol/water coefficient
6. Manufacturer Declaration
• Complete quali-quantitative composition including all
impurities > or = 0.1%
• Description of analytical method to quantify impurities
(validated methods)
• Description of produtive process with all steps, reagents,
chemical reactions, reactions parameters, critical points, quality
control and purification steps
• Complete flowchart and chemical reactions
• Chemical discussion about all possible impurities
7. LABORATORY STUDIES
• 5-Batch Report
• Melting/Boiling Point
• Water solubility/ solubility in organic solvent
• Partition coefficient N-octanol/water
• Vapour Pressure
13. MAPA
• Field Studies in all crops (3 different places in Brazil or 3
different season) – excemption – same product to same crops
at same dosis - field studies are not necessary
• Residues Studies in all crops (4 places or 2 different season of
the crop)
14. ANVISA
• Acute oral toxicity (LD50)
• Acute dermal toxicity
• Inhalation acute toxicity (LC50)
• Dermal irritation
• Eye irritation
• Skin Sensitization
• Ames Test
• Micronucleous Test
• Residues Studies in all crops (studies before 2000)
15. IBAMA
• Physico-Chemical Studies
• Toxicity to microorganisms, algae, microcrustacean, fish, honey
bees, earthworm, avian, phytotoxicity
• Toxicity to mammals ( 6 pack studies)
• Mutagenicity (Ames and Micronucleous)
17. PROREGISTROS HELP ON
• Obtain RET
• Import samples
• Follow up the laboratory analysis strictly according
international guidelines and brazilian legal procedures;
• Registration of Technical Product
• Registration of Ingredients
• Registration of Formulated Product
• Registration of Formulated Product in all states of interest