SIMPLIFIED DATA REQUIREMENTS FOR REGISTRATION OF PESTICIDES UNDER SECTION 9(3B) OF THE ACT FOR USE IN FLORICULTURE (AS APPROVED BY THE REGISTRATION COMMITTEE IN ITS 167TH MEETING HELD ON 22.03.1997)
Parameters |
Data Requirements |
|||||
| Imported Technical Grade | Indicenous manufacture of formulation | Import of formulated material | ||||
| 1 | 2 | 3 | 4 | |||
| A. | CHEMISTRY | |||||
| 1. | Source of Import | R | NR | R | ||
| 2. | Chemical Composition | R | R | R | ||
| 3. | Chemical Identity | R | R | R | ||
| 4. | Physico-chemical properties | R | R | R | ||
| 5. | Technical Bulletin | R | NR | NR | ||
| 6. | Specification | R | R | R | ||
| 7. | Method of Analysis | R | R | R | ||
| 8. | Analytical Test Report | R | R | R | ||
| 9. | Identification and quantification of identifiable impurities | NR | NR | NR | ||
| 10. | Shelf-life claim | R | R | R | ||
| B. | BIOEFFICACY & RESIDUES | |||||
| 1. | Bioeffectiveness | NR | R | R | Data generated at any of the two Institutes viz. IIHR, Bangalore, IARI, New Delhi and State Agri. Universities. | |
| 2. | Phytotoxicity | NR | R | R | ||
| 3. | Residue tolerance limit | NR | R | R | ||
| 4. | Purpose for import / mfg | R | R | R | ||
| 5. | Direction concerning usages | NR | R | R | ||
| 6. | Time of application | NR | R | R | ||
| 7. | Application equipment | NR | R | R | ||
| 8. | Information regarding registration status in other countries | R | R | R | ||
| 9. | Translocation within plants | R | NR | R | ||
| 10. | Persistance in plants | R | NR | R | ||
| 11. | Foreign data on bioeffectiveness | NR | NR | R | ||
| 12. | Labels / leaflets giving bioefficacy claims in the manner approved by Registration Committee. | NR | R | R | ||
| 13. | Metabolism in plant | R | NR | NR | ||
| C. | TOXICITY | |||||
| 1. | Acute oral in rat and mice | R | R | R | ||
| 2. | Acute dermal | R | R | R | ||
| 3. | Acute inhalation | R | R | R | ||
| 4. | Primary skin irritation | R | R | R | ||
| 5. | Irritation to mucous membrane. | R | R | R | ||
| 6. | Sub-acute oral in rat and dog | R | NR | R | ||
| 7. | Sub-acute dermal | R | NR | R | ||
| 8. | Sub-acute inhalation | R | NR | R | ||
| 9. | Toxicity to birds | NR | R | R | ||
| 10. | Toxicity to fish | NR | R | R | ||
| 11. | Toxicity to honeybees | NR | R | R | ||
| 12. | Medical data | R | R | R | ||
| 13. | Observation in man (Health records of spraymen) | NR | R | R | ||
| 14. | Toxicity to livestock (field trial and observations) | NR | R | R | ||
| 15. | Neurotoxicity | R | Authentic Information Required | NR | R | Information International Organization |
| 16. | Teratogenicity | R | NR | R | ||
| 17. | Effect on reproduction | R | NR | R | ||
| 18. | Carcinogenicity | R | NR | R | ||
| 19. | Metabolism | R | NR | R | ||
| 20. | Mutagenicity | R | NR | R | ||
| 21. | Human toxicity information from foreign countries | R | NR | R | ||
| D. | PACKAGING & LABELLING | |||||
| 1. | Labels and Leaflets as per IR 1971 existing norm | R | R | R | ||
| 2. | Type of packaging (packaging material + compatibility with content) | Type of packaging required | Type of packaging required | R | ||
| 3. | Manner of Packaging | R | R | R | ||
| 4. | Process of formulation | NR | R | NR | ||
| 5. | Manner of labelling | R | NR | NR | ||
| 6. | Instructions for storage and use | R | R | R | ||
| 7. | Information regarding disposal of used containers | R | R | R | ||
R - Required
NR - Not required.