DATA REQUIREMENT FOR REGISTRATION OF PESTICIDES EXCLUSIVELY FOR EXPORT
| CATEGORIES OF PESTICIDES FOR EXPORT REGISTRATION |
| Category- I |
| Import and indigenous manufacture of technical grade pesticides, not registered for import/indigenous manufacture & use in the country |
| Category-II |
| Indigenous manufacture of pesticide formulations based on technical grade pesticides not registered for use in the country. (in case of formulation export, separate application for import / manufacture of technical grade pesticide is required to be submitted.) |
| Category-III |
| Indigenous manufacture of pesticides (technical grade or their formulations) already registered for use in the country with same or different impurity profile / different adjuvant with same, lower or higher concentration and new types of formulations. ( In case of registered pesticides, import from approved source only). |
| Category-IV |
| New combination formulations. ( In case of new unregistered constituents, separate application is required to be submitted.) |
| Category-V |
| Neem based pesticides and Biopesticides (Bt. & Bs) |
| Category-VI |
| Baculoviruses (NPV, GV), Antagonistic Bacteria Fungi & Entomogenous fungi |
GUIDELINES OF REGISTRATION FOR PESTICIDES EXCLUSIVELY FOR EXPORT
(A) CHEMISTRY
| Sl. No. |
Parameter |
Category |
||||
| I | II | III | IV | V(neem based) | ||
| 1. | Chemical composition having i. Minimum purity ii. Known impurity profile |
R | R | R | R | R |
| 2. | Physico-chemical properties of a.i. | R | R | R | R | R |
| 3. | Specification along with undertaking for product quality as per BIS format | R | R | R | R | |
| 4. | Method of analysis | R | R | R | R | R |
| 5. | Outline of process of manufacture, raw material used / process of extraction of a.i. | NR | R | NR | NR | R |
| 6. | Source of import | R | NR | NR | NR | NR
|
| Sl. No. | Parameter | Category - V(Bt. & Bs.) & VI |
|
| Technical | Formulations | ||
| 1. | Systematic name, Common name and strain | R | R |
| 2. | Natural occurrence of the organism, it is relationship to other species and morphological history. | R | R |
| 3. | Chemical composition and physico-chemical properties | R | R |
| 4. | Specification for product quality along with undertaking registration the product as NOT, GMO / naturally occurring. | R | R |
| 5. | Method of analysis a. Determination of the toxin contents b. Determination of potency |
R R R |
R R R |
(B) TOXICITY
| Sl. No. | Parameter |
Category |
||||
| I | II | III | IV | V(Neem based) | ||
| 1. | Acute oral in rat | R* | R* | NR* | R* | R* |
| 2. | Acute dermal | R* | R* | NR* | R* | R* |
| 3. | Acute inhalation | R* | R* | NR* | R* | NR |
| 4. | Primary skin irritation | R* | R* | NR* | R* | R* |
| 5. | Irritation to mucous membrane | R* | R* | NR* | R* | R* |
| 6. | Effect on reproduction | R** | NR | NR | NR | R** |
| 7. | Carcinogenicity | R** | NR | NR | NR | R** |
| 8. | Mutagenicity | R** | NR | NR | NR | R** |
| 9. | Neuro toxicity | NR | NR | NR | NR | R** |
| 10. | Sign and symptoms of poisoning & treatment | R | R | R | R | R |
* Published information on LD 50 / LC 50/ irritation index (moderate / severe / mild / none) score value. Alternatively same information as per studies undertaken according to the guidelines of OECD, EPA or the importing country / as per existing guidelines of Registration Committee.
** Information on these parameters shall be acceptable from any of the following sources :
i. From the reviews undertaken by International organizations / Institutions like WHO, joint bodies or FAO/WHO, International Registry for Potential Toxic Chemicals (IRPTC), International Agency or Research on Cancer (IARC) etc.
ii. Authenticated information from the Laboratory / Institute which would have undertaken these studies.
iii. Authentic information on these parameters from any National Pesticide Registration Authority.
iv. Information supported with published research studies / evaluation.
v. Information with relevent details on these parameters could be considered if secured through Internet or Medline search.
| S.No. | Parameter | Category V B.t & B.s |
|
| Technical | Formulation | ||
| Single Exposure studies | |||
| 1. | Oral toxicity / Pathogenecity | R | R |
| 2. | Dermal toxicity / Pathogenecity | R | R |
| 3. | Mucous membrane irritation | R | R |
| 4. | Primary skin irritation | R | R |
| 5. | Inhalation toxicity / Pathogenecity | R | R |
| 6. | Allergy / Sensitization | R | R |
Note : Allergy test has to be conducted as per Standard Protocol prescribed by BIS.
CATEGORY VI
(I) Baculoviruses (NPV & GV)
If the same primary culture is used for making formulation by different entrepreneurs then the information submitted once on primary culture will be sufficient. All entrepreneurs need not to submit information. No toxicity information is required for formulation if it is derived from the primary culture which is already registered or on which information has been submitted. The information on following parameters is required to be submitted for the primary culture :
i) Single Dose Oral (Rat and Mouse) Toxicity/Infectivity/Pathogenicity
ii) Single Dose Pulmonary Toxicity/Infectivity/Pathogenicity
iii) Single Dose Intravenous Toxicity/Infectivity/Pathogenicity
iv) Cell Culture
v) Primary Skin & Eye Irritation
(II) Atagonistic Bacteria Fungi & Entomogenous Fungi
If the same primary culture is used for making formulation by different entrepreneurs then the information submitted once on primary culture will be sufficient. All entrepreneurs need not to submit information. No toxicity information is required for formulation if it is derived from the primary culture already registered or on which information has been submitted. The information on following parameters is required to be submitted for the primary culture :
i) Single Dose Oral (Rat and Mouse) Toxicity/Infectivity/Pathogenicity
ii) Single Dose Pulmonary Toxicity/Infectivity/Pathogenicity
iii) Single Dose Dermal
iv) Single Dose Intraperitoneal
v) Primary Skin & Eye Irritation
(C) Packaging & labeling
For chemical pesticides :
1. An undertaking w.r.t. type of packaging
2. Labels/Leafl;ets as per Insecticides Rules, 1971
For Biopesticides
| S.No. | Parameter | Technical | Formulation |
| 1. | Packaging material for moisture proof barrier to reduce the
impurities of the product shall be proposed as per the exporting countries requirements: a) Primary packing b) Secondary packing c) Transport packing |
R | R |
| 2. | An undertaking with regard to packaging requirements as per the exporting country. | R | R |
| 3. | Seven copies of labels and leaflets complying the requirements as per Insecticides Rules, 1971 for small size packing up to 250 mg/ml and large size packing of 500 mg/ml and above shall be furnished. | R | R |