DATA REQUIREMENTS FOR REGISTRATION OF COMBINATION PRODUCTS OF TWO REGISTERED HERBICIDES AS APPROVED BY THE REGISTRATION COMMITTEE IN ITS 145th MEETING HELD ON 22.02.1994.
| A. | CHEMISTRY | |
| 1. | Detailed chemical composition. | R |
| 2. | Chemical identity of individual a. i content | R |
| 3. | Physico-chemical properties of the combination product | R |
| 4. | Specifications | R |
| 5. | Method of analysis | R |
| 6. | Analytical test report | R |
| 7. | Shelf-life claim / data | R |
| 8. | Manufacturing process | R |
| B. | BIO-EFFICACY | |
| 1. | Bio-effectiveness | R |
| 2. | Phytotoxicity. | R |
| 3. | Persistence in soil* | R |
| 4. | Persistence in plant* | R |
| 5. | Persistence in water* | R |
| 6. | Compatibility with other chemicals** | R |
| 7. | Residues in plant* | R |
| 8. | Residues in soil* | R |
| * If the a.i. content in the combination product is higher
than the a.i. contact of the registered formulation under the Insecticides Act, the
applicant is required to submit the data. ** If the product is proposed to be mixed with other chemicals, the data on compatibility with these chemicals are required to be submitted. |
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| C. | TOXICOLOGY | |
| 1. | Technical product of individual pesticides should be regularly registered. | R |
| 2. | The toxicity data on Final Product (Combination product have to be generated as per the data prescribed for formulated products in Gaitonde Committee report provided that the strength of individual component is lower than the registered formulations. Whenever any of the | R |
| 3. | Primary skin irritation | R |
| 4. | The components of combination should preferably be limited to two only. | R |
| D. | PACKAGING AND LABELLING | |
| 1. | Label and Leaflets as per Insecticides Rules, 1971 existing norms. | R |
| 2. | Type of packing | R |
| 3. | Manner of Packing (Packaging material plus compatibility with content) | R |
| 4. | Specifications for primary packing | R |
| 5. | Specifications for secondary packing | R |
| 6. | Specifications for transport packing | R |
| 7. | Manner of Labelling | R |
| 8. | Instructions for storage and use, etc. | R |
| 9. | Information regarding disposal of used package. | R |
R- Required