DATA REQUIREMENTS FOR REGISTRATION OF NEEM BASED PESTICIDES
| A. | CHEMISTRY | |
| 1. | Name of the Part of the Plant(s) to be used for extraction of the active ingredients / components. | R |
| 2. | Outline of process of manufacture clearly identifying the chemicals as indicated in point(3) below. | R |
| 3. | (a) Neem extract Contains "Azadirachtin" as one of
the major active constituents. The concentration of Azadirachtin in the formulated
neem extract should contain not less than 1500 ppm of Azadirachtin a.i.in
"Kernel" based formulations and 300 ppm in "Neem oil" based
formulations.. (b) When the insecticidal a.i. is other than Azadirachtin then the applicant has to indicate the name, quality and quantity of that particular a.i. (s). |
R
|
| 4. | Chemical identity of the ingredient as stated at point (3) above. | R |
| 5. | Physico-chemical properties. | R |
| 6. | Specifications of ingredient as indicated at point (3) above. | R |
| 7. | Method of analysis for Azadirachtin / other insecticidal a.i. other than Azadirachtin. | R |
| 8. | Analytical test report | R |
| 10. | Shelf-life claim / data. | R |
| B. | BIO-EFFICACY | |
| 1. | Bio-effectiveness | R |
| 2. | Phytotoxicity | R |
| 3. | Compatibility with other chemicals | R |
| 4. | Purpose of manufacture | R |
| 5. | Direction concerning dosage | R |
| 6. | Time of application | R |
| 7. | Waiting period | R |
| 8. | Application equipment | R |
| 9. | Information regarding registration status in other countries, if any | R |
| C. | TOXICITY : Data on parameters 1 to 3 are required for 9(3b) registration. | |
| 1. | Acute oral rat and mice | R |
| 2. | Acute dermal | R |
| 3. | Primary skin irritation, irritation to mucous membrane. | R |
| 4. | Neuro-behavioural toxicity | R |
| 5. | Reproductive toxicity. | R |
| 6. | Careinogenicity | R |
| 7. | Mutagenicity | R |
| 8. | Effect on spray operators (Health records) : As per the protocol to be approved by the Registration Committee. | R |
| D. | PACKAGING AND LABELLING | |
| 1. | Labels and Leaflets as per IR 1971 existing norms | R |
| 2. | Type of packaging (container content compatibility data) | R |
| 3. | Manner of Labelling (Container - content compatibility data) | R |
| 4. | Specification for primary package | R |
| 5. | Specification for secondary package | R |
| 6. | Specification for transport package | R |
| 7. | Manner of labelling | R |
| 8. | Instructions for storage and use | R |
| 9. | Information regarding disposal of used package | R |
| 10. | Process of manufacturing / indicating material balance generation of wasted. | R |
| 11. | Long Term Toxicity | R |
| i. | Neuro-behaviour toxicity | R |
| ii. | Mutagenicity | R |
| iii. | Careinogenecity | R |
| iv. | Effect on reproduction | R |
| v. | Health records of workers / spray operators as per the protocol to be approved by the Registration Committee | R |
| PACKAGING & LABELLING | ||
| 1. | Labels and Leaflets | R |
| 2. | Type of packing | R |
| 3. | Manner of packing | R |
| 4. | Content container compatibility data shall be generated in an independent reputed laboratory. | R |
| 5. | Manner of labelling | R |
| 6. | Specifications of packing | R |
| i. Primary packing | R | |
| ii. Secondary packing | R | |
| iii. Transport packing | R | |
| 7. | Instructions for storage and use | R |
| 8. | Disposal of empty containers | R |
R- Required
NR- Not required.