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PESTICIDES REGISTRATION

            BRAZIL
  LAW 9802/89, MANDATORIES
     4074/2001, 5981/2006
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
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
TECHNICAL PRODUCTS



       STEP 1
CHEMICAL EQUIVALENCE
LABORATORY ANALYSIS
•   Five batch analysis
•   Vapour Pressure
•   Boiling/Melting point
•   Solubility
•   N-octanol/water coefficient
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
LABORATORY STUDIES
•   5-Batch Report
•   Melting/Boiling Point
•   Water solubility/ solubility in organic solvent
•   Partition coefficient N-octanol/water
•   Vapour Pressure
TECHNICAL PRODUCTS



         STEP 2
TOXICOLOGICAL EVALUATION
LABORATORY STUDIES
•   Acute oral toxicity (LD50)
•   Acute dermal toxicity
•   Inhalation acute toxicity (LC50)
•   Dermal irritation
•   Eye irritation
•   Skin Sensitization
•   Ames Test
•   Micronucleous Test
TECHNICAL PRODUCTS

          STEP 3
COMPLEMENTARY TOXICOLOGICAL
         STUDIES
LABORATORY STUDIES
•   According evaluation of CTA (IBAMA, ANVISA, MAPA)
•   Sub Acute Toxicological Studies
•   Sub Chronic Toxicological Studies
•   Ecotoxicological Studies
•   Chronic Studies
FORMULATED PRODUCT
• MAPA – Efficacy Studies
• ANVISA – Toxicological and Residue Studies
• IBAMA – Ecotoxicological Studies
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)
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)
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)
WHAT PROREGISTROS
       DO?
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

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Pesticides registration brazil 2012

  • 1. PESTICIDES REGISTRATION BRAZIL LAW 9802/89, MANDATORIES 4074/2001, 5981/2006
  • 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
  • 4. TECHNICAL PRODUCTS STEP 1 CHEMICAL EQUIVALENCE
  • 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
  • 8. TECHNICAL PRODUCTS STEP 2 TOXICOLOGICAL EVALUATION
  • 9. LABORATORY STUDIES • Acute oral toxicity (LD50) • Acute dermal toxicity • Inhalation acute toxicity (LC50) • Dermal irritation • Eye irritation • Skin Sensitization • Ames Test • Micronucleous Test
  • 10. TECHNICAL PRODUCTS STEP 3 COMPLEMENTARY TOXICOLOGICAL STUDIES
  • 11. LABORATORY STUDIES • According evaluation of CTA (IBAMA, ANVISA, MAPA) • Sub Acute Toxicological Studies • Sub Chronic Toxicological Studies • Ecotoxicological Studies • Chronic Studies
  • 12. FORMULATED PRODUCT • MAPA – Efficacy Studies • ANVISA – Toxicological and Residue Studies • IBAMA – Ecotoxicological Studies
  • 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