Guidelines/ data requirement approved by the Registration Committee in its 186th meeting for registration of Neem based products containing Azadirachtin to be used as household insecticides.
PARAMETER |
9(3B) | 9(3) | |
| A. | CHEMISTRY | ||
| The common name of the household insecticides which is to be printed on the labels and leaflets should also contain minimum percentage of Azadirachtin content. | R | R | |
| 1. | Chemical composition and allied data requirements.
|
||
| Source of supply of the technical grade material / neem extract concentrate with minimum purity to be used in the formulation should be given. | R | R | |
| 2. | Chemical Composition | ||
| 2.1 | Complete chemical composition of the formulation should be submitted. | R | R |
| 2.2 | Complete identity and physico-chemical characteristics of various ingredients used in the formulation should be submitted. | R | R |
| 2.3 | The chemical composition for the formulation should include the kind, name and percentage of all the ingredients that is to be used in the formulation. | R | R |
| 2.4 | The active ingredients in the house hold insecticides should be only Azadirachtin and other constituents associated during extraction of neem. Kernel free friom aflatoxin. | R | R |
| 3. | Specifications | ||
| Specification depending on the coding of the product as per BIS format alongwith undertaking for quality should be submitted. | R | R | |
| 4. | Analytical test report | R | R |
| The analytical test report giving the analysis of a particular batch of all the parameters included in the specifications should be submitted from an independent reputed national / international laboratory. | R | R | |
| 5. | Shelf-life claim | ||
| An underting regarding shelf life claim should be submitted | R | R | |
| 6. | Shelf-life data | ||
| Shelf life data as per existing guidelines in support of shelf life claim should be submitted. | NR | R | |
| 7. | Method of analysis | ||
| Method of analysis should be submitted (whereever BIS method is available, the same should be submitted). The sample of the product and reference standard should be submitted. Detailed method of extraction of the active ingredient and process of formulation should be submitted. | R | R | |
| B. | BIO-EFFICACY | ||
| 1. | Bio-effectiveness | ||
| i. Bio-efficacy data generated at National Laboratories | R | R | |
| 2. | Residual Toxicity | R | R |
| i. Bio-efficacy tests on the proposed formulations should be conducted under Indian conditions at National Laboratories | R | R | |
| ii. Data on persistance on residual toxicity of insecticides on different type of surfaces should be generated. | R | R | |
| 3. | General Information on label / leaflets | ||
| i. A brief direction concerning the major uses of the insecticide should be given on the labels. | R | R | |
| ii. Instruction regarding Insecticide : Not to be used on any food crops" to be given both on label and leaflets | R | R | |
| iii. Detailed information on the uses of Insecticide indicating the name of insects, method of application, dosage, places of treatments, Plant Protection Equipments to be used etc. should be given in the leaflets. | R | R | |
| C. | TOXICITY | ||
| 1. | Acute oral toxicity rat. | R | R |
| 2. | Acute oral toxicity mice | R | R |
| 3. | Acute dermal toxicity | R | R |
| 4. | Acute inhalation toxicity | R | R |
| 5. | Primary skin irritation | R | R |
| 6. | Irritation to mucus membrane | R | R |
| 7. | Neuro-behavioural toxicity | NR | R |
| 8. | Reproduction toxicity | NR | R |
| 9. | Careinogenecity | NR | R |
| 10. | Mutagenicity | NR | R |
| 11. | Health monitoring study of the users and /or spray operators
by using the household pesticide in actual use. These studies shall be conducted as per
the protocols approved by the Registration Committee. * To be submitted for only category III household insecticides which emit vapours e.g. mats and coils etc. |
NR | R |
| D. | PACKAGING AND LABELLING | ||
| I. | Label and Leaflets | ||
| i. 7 copies of labels and leaflets prescribed for small size container upto 250 ml. capacity as per provisions of Insecticides Rules, 1971. | R | R | |
| ii. 7 copies of labels and leaflets prescribed for large size container above 250 ml. capacity as per provisions of Insecticides Rules, 1971. | R | R | |
| II. | Type of Packaging | ||
| i. Information about the packaging materials proposed packaging of the product in retail or bulk. | R | R | |
| ii. Data on compatibility of the packaging materials with the content as per the method prescribed in relevent IS standard. | R | R | |
| iii. Information / data on suitability of the proposed packaging system for protecting the content through out the shelf life. | NR | R | |
| iv. Information on the proposed packaging materials regarding its incorporation in IS standard / Environment friendly notification by the Ministry of Environment. | R | R | |
| III. | Manner of Packaging | ||
| i. Information regarding filling, sealing of closure system, pilfer proofness, leakproofness on primary packaging, secondary packaging and transport packaging. | R | R | |
| ii. Undertaking for the use of pilfer proof, leak proof and easily disposable container for packing the product | R | R | |
| IV. | Transportation | ||
| Undertaking for safe storage, handling and transportation of the product. | NR | R | |
| V. | Manner of Labelling | ||
| i. Information as per provisions 18 & 12 of Insecticides Rules, 1971 should be furnished | R | R | |
| ii. Instruction for storage and use including precautionary measures should be proposed. | R | R | |
| iii. Instructions regarding disposal of used material and washing of insecticides should be proposed. | R | R | |
R- Required
NR- Not required.