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Checklist for Bio-efficacy data requirement for registration of already registered formulations (as foliar spray) for Label Expansion of
Seed Treatment U/S. 9(3)
(For already registered formulations as foliar spray, application for seed treatment would be considered as label expansion).
Sr.
No.
Requirement as per guidelines
Required /
Not
Required
Details of Data
requirement
Season and location Whether Data
submitted / Not
submitted
Remarks
1. Bio-effectiveness Required Two season/ year data
from multi-location data
for each crop as per label
claim from different
agro-climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2 -Location B
Season 2-Location C
2. Phytotoxicity Required Two season/ year data
from multi-location data
for each crop as per label
claim from different
agro-climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2 -Location B
Season 2-Location C
3. Residue in Plant Required i) Required for additional crop as per
label claim.
ii) Required for vegetable crop and
crops where young seedling are
consumed as vegetables
4. Persistence in Plant Required i) Required for additional crop as per
label claim.
ii) Required for vegetable crop and crops where young seedling are
consumed as vegetables
5. Registration status in foreign countries
Required
6. Effect on soil microorganisms Required
7. Form I Required
8. Label & Leaflets (7 copies) in
Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant.
Checklist for bio- efficacy data requirements for registration of antagonistic bacteria under section 9(3)
Sr.
No.
Requirement as per guidelines
Required /
Not
Required
Details of Data
requirement
Season and location Whether Data
submitted /
Not submitted
Remarks
1. Field tests:
Data from SAU’s/ICAR Institute
certified by Director Research or
Head of the Institute
Required Two season/ year
data from three agro-
climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
2. Data on non-target organism:
One season/one year data
Required
3. Laboratory tests:
Required The product should
be tested at one
laboratory under
ICAR/ SAU/ CSIR
4. Label & Leaflets (7 copies) in
Hindi & English
Required
Name and signature of Preliminary scrutiny assistant
Checklist for bio-efficacy data requirements for registration of Antagonistic Fungi under section 9(3)
Sr.
No.
Requirement as per guidelines
Required /
Not
Required
Details of Data
requirement
Season and location Whether Data
submitted / Not
submitted
Remarks
1. Field studies:
Data from SAU’s/ICAR Institute
certified by Director Research of SAU or Head of the ICAR Institute
Required Two season/ year data
from three agro-
climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
2. Laboratory studies:
Required The product should be
tested at a laboratory
under ICAR/ SAU/ CSIR/ICMR.
3. Label & Leaflets (7 copies) in Hindi
& English
Required
Name and Signature of preliminary scrutiny assistant
Checklist for Bio-efficacy data requirement for requirements for registration of combination product of one registered insecticide and one registered fungicide for Seed Treatment u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not Required
Details of Data requirement Season and location Whether Data
submitted / Not submitted
Remarks
1. Bio-effectiveness Required Bio-efficacy evaluation of insecticide
and fungicide alone and in combination is to be evaluated against
insect pest(s) and disease(s) as per
label claim(s) under different agro
climatic conditions for two season
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
2.
Phytotoxicity Required Bio-efficacy evaluation of insecticide
and fungicide alone and in combination is to be evaluated against
insect pest(s) and disease(s) as per
label claim(s) under different agro climatic conditions for two seasons
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
3, Persistence in Plant Required If the a.i. content in the combination product is higher than the a.i. content
of the registered formulations under
the Insecticides Act, the applicant is required to submit the data.
4. Persistence in Soil Required If the a.i. content in the combination
product is higher than the a.i. content
of the registered formulations under
the Insecticides Act, the applicant is required to submit the data.
5. Persistence in water Required If the a.i. content in the combination
product is higher than the a.i. content
of the registered formulations under the Insecticides Act, the applicant is
required to submit the data.
6. Compatibility with
other chemicals
Required If the product is proposed to be mixed with other chemicals, the data on
compatibility with these chemicals are
required to be submitted.
7. Residue in plant Required If the a.i. content in the combination product is higher than the a.i. content
of the registered formulation under
the Insecticides Act, the applicant is required to submit the data.
8. Copy of RTT if
applicable
Required
9. Form - I Required
10. Label & Leaflets (7
copies) in Hindi &
English
Required
Name & Signature of Preliminary Scrutiny Assistant.
Checklist for bio-effectiveness for Formulation Import (FI) u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of data
required
Season and
Location
Whether Data
submitted / Not
submitted
Remarks
1. Bio-efficacy Required Two season /
year data Generated
at minimum
Three agro-climatic conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
2. Phytotoxicity Required Two season / year data
Generated
at minimum Three agro-climatic
conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
3. Effect on parasite &
predators
Not Required -- --
--
--
--
--
--
4. Translocation in Plants Not Required -- -- -- --
5. Metabolism in Soil Not Required -- -- -- --
6. Metabolism in Water Not Required -- -- -- --
7. Metabolism in Plant Not Required -- -- -- --
8. Persistence in Soil Required
9. Persistence in Water Required
10. Persistence in Plant Required
11. Compatibility with
other chemicals if
claimed
Required
12. Residues in Plant Required One season/ year data
generated at
minimum four Agro
climactic conditions.
Location A.
Location B.
Location C.
Location D.
13. Residues in Soil Required One season/ year data
generated at minimum four Agro
climactic conditions.
Location A.
Location B.
Location C.
Location D.
14. Residue tolerance limit fixed by foreign
countries
Required
15. Cost Benefit ratio. Not Required. -- -- -- --
16. Registration status in Foreign countries
Not Required. -- -- -- --
17. Form – I Required
18. Copy of RTT permit Required
19. MRL Proforma in
Duplicate with CD
Required
20. Label & Leaflets (7
copies) in Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant
Checklist for bio-effectiveness for Formulation Indigenous Manufacture (FIM) u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of data
required
Season and
Location
Whether Data
submitted / Not
submitted
Remarks
1. Bio-effectiveness Required Two season /
year data Generated
at minimum
Three agro-climatic conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
2. Phytotoxicity Required Two season / year data
Generated
at minimum Three agro-climatic
conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
3. Effect on parasite &
predators
Not Required -- --
--
--
--
--
-- 4. Translocation in Plants Not Required -- -- -- --
5. Metabolism in Soil Not Required -- -- -- --
6. Metabolism in Water Not Required -- -- -- --
7. Metabolism in Plant Not Required -- -- -- --
8. Persistence in Soil Required
9. Persistence in Water Required
10. Persistence in Plant Required
11. Compatibility with
other chemicals if
claimed
Required
12. Residues in Plant Required One season/ year data generated at
minimum four Agro
climactic conditions.
Location A.
Location B.
Location C.
Location D.
13. Residues in Soil Required One season/ year data
generated at
minimum four Agro climactic conditions.
Location A.
Location B.
Location C.
Location D.
14. Residue tolerance limit fixed by foreign
countries
Required
15. Cost Benefit ratio. Not Required. -- -- -- --
16. Registration status in Foreign countries
Not Required. -- -- -- --
17. Form – I Required
18. MRL Proforma in
duplicate with CD
Required
19. Label & Leaflets 97
copies) in Hindi &
English
Required
Name & Signature of Preliminary Scrutiny Assistant
Check list for Bioefficacy data requirement for registration of FIM vs FI
Guidelines for Registration of FIM vs FI (Formulation Indigenous Manufacture vs
Formulation Import) – as approved in 315th meeting of Registration Committee held on
22nd February, 2011
The Guidelines for the category of FIM Vs. FI are as under:-
(a) For registration of pesticide formulation for indigenous manufacture having the identical chemical composition that of formulation already registered for import U/s.9(3).
No data is required provided the technical of the source to be used in formulation is duly registered as per
guidelines of the Registration Committee and the label claims are same.
(b) For registration of pesticide formulation for indigenous manufacture having the different chemical composition that of formulation already registered for import U/s.9(3).
Complete data to be submitted as per already existing guidelines for formulation indigenous manufacture
(FIM) U/s. 9(3) provided the technical (source) to be used for making formulation is duly registered as per
guidelines of the Registration Committee.
Checklist for Bio-efficacy data requirements for registration of import of formulation of pesticide from New Source where import of
formulation has been registered without registration of Technical U/S 9(3)
Sr.
No.
Requirement as per guidelines
Required /
Not Required
Details of Data
requirement
Season and location Whether Data
submitted / Not
submitted
Remarks
1. Bio-efficacy Required Two season/ year data
from three agro-
climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
2. Phytotoxicity Required Two season/ year data
from three agro-
climatic conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
3. Effect on parasites & predators
Not Required -- --
--
--
--
--
--
4. Translocation in plant Not Required
5. Metabolism in soil Not Required
6. Metabolism in water Not Required
7. Metabolism in plant Not Required
8. Persistence in soil Required
9. Persistence in water Required
10. Persistence in plant Required
11. Compatibility with other chemicals,
if claimed
Required
12. Residues in plant Required One season / year data at four location in
different Agro -
climatic condition
Location - 1
Location - 2
Location - 3
Location - 4
13. Residues in soil Require One season / year data
at four location in
different Agro - climatic condition
Location - 1
Location - 2
Location - 3
Location - 4
14. Residue tolerance limits fixed by
foreign countries
Required
15. Cost Benefit Ratio Not Required -- -- -- --
16. Registration Stats in foreign
countries
Required
17. Copy of RTT Required
18. Form – I Required
19. Label & Leaflets (7 copies) in Hindi
& English
Required
Name & Signature of Preliminary Scrutiny Assistant.
Checklist for bio-efficacy data Requirement for Registration of New Formulation for Seed Treatment U/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of Data requirement Season and location Whether Data
submitted /
Not submitted
Remarks
1. Bio-effectiveness Required Bio-efficacy evaluation of the product for seed treatment is to be evaluated against insect pest (s), diseases (s) as per label claim (s) under different agro-climatic zones/ multi-location field trial for two season/ year.
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2 -Location B
Season 2-Location C
2. Phytotoxicity Required Bio-efficacy evaluation of the product for seed treatment is to be evaluated against insect pest (s), diseases (s) as per label claim (s) under different agro-climatic zones/ multi-location field trial for two season/ year.
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2 -Location B
Season 2-Location C
3. Effect on parasite & predators
Required Data on effect on soil microorganisms is required.
4. Persistence in Soil, Water & Plant.
Required Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2 -Location B
Season 2-Location C
5. Compatibility with other chemicals,
if claimed.
Required If the product is proposed to be mixed with other chemicals, the data on compatibility with other pesticides/bio-pesticides and bio-fertilizers used for seed dressing are required to be submitted.
6. Residue in plant Required Residue data as per label claim for four locations, one season is required to be submitted
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 1-Location D
7. Residue in Soil Required Residue data as per label claim for four locations, one season is required to be submitted
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 1-Location D
8. Registration status in foreign countries
Required
9. Copy of Form - I Required
10. Chemical composition Required
11. Copy of RTT permit, if relevant
Required
12. Label & Leaflets (7 copies) in Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant.
Checklist for bio-efficacy data requirement for registration of New formulation (of same a.i.) where another formulation (of
same a.i.) is already registered for Seed Treatment u/s 9(3)
Sr.
No.
Requirement as per guidelines
Required /
Not Required
Details of Data
requirement
Season and location Whether Data
submitted / Not
submitted
Remarks
1. Bio-effectiveness Required Two season/ year data from four agro-climatic
conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 1-Location D
Season 2-Location A
Season 2-Location B
Season 1-Location C
Season 1-Location D
2. Phytotoxicity Required Two season/ year data from four agro-climatic
conditions
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 1-Location D
Season 2-Location A
Season 2-Location B
Season 1-Location C
Season 1-Location D
3. Residue in Plant Required
i) Required for additional crop as per label claim
ii) Required for vegetable crops and
crops where young seedlings are
consumed as vegetables.
4. Persistence in plant
Required
i) Required for additional crop as per label claim
ii) Required for vegetable crops and crops where young seedlings are
consumed as vegetables.
5. Persistence in soil
Required
i) Required for additional crop as per label claim
ii) Required for vegetable crops and crops where young seedlings are
consumed as vegetables.
6. Persistence in water:
Required
i) Required for additional crop as per label claim
ii) Required for vegetable crops and crops where young seedlings are consumed as vegetables.
7. Registration status in foreign countries-
Required
8. Copy of RTT if applicable Required
9. Form – I Required
10. Label & Leaflets (7 copies) in Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant.
Checklist for bio-effectiveness for Technical Import u/s 9(3)
Sr.
No.
Requirement as per guidelines
Required / Not
Required
Whether Data submitted /
Not submitted
Remarks
1. Bio-efficacy Not Required -- --
2. Phytotoxicity – Not Required -- --
3. Effect on parasite & predators Not Required -- --
4. Translocation in Plants Required
5. Metabolism in Soil Required
6. Metabolism in Water Required
7. Metabolism in Plant Required
8. Persistence in Soil Required
9. Persistence in Water Required
10. Persistence in Plant Required
11. Compatibility with other chemicals
if claimed Not Required -- --
12. Residues in Plant Not Required -- --
13. Residues in Soil Not Required -- --
14. Residue tolerance limit fixed by
foreign countries Not Required -- --
15. Cost Benefit ratio. Not Required. -- --
16. Registration status in Foreign countries
Required.
17. Copy of RTT permit Required
18. Form – I Required
19. Label & Leaflets (7copies) in Hindi
& English Required
Name & Sign of preliminary Scrutiny Assistant
Checklist for bio-effectiveness for TI (New Source) u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of data
required
Season and
Location
Whether Data
submitted /
Not submitted
Remarks
1. Bio-efficacy Required Two season data- on each crop as per label leafletfrom at least two climatic zone 1.(If file submitted within four years from the date of issue of RTT permit 2. If file is not submitted within stipulated time period then data required on all crops as per label leaflet at the time of submission of file
Season 1-Zone A-Crops as per label leaflet
Season 1-Zone B-Crops as per label leaflet
Season 2-Zone A-Crops as per label leaflet
Season 2-Zone B-Crops as per label leaflet
2. Phytotoxicity Required Two season data- on each crop as per label leaflet from at least two climatic zone 1.(If file submitted within four years from the date of issue of RTT permit 2. If file is not submitted within stipulated time period then data required on all crops as per label leaflet at the time of submission of file
Season 1-Zone A-Crops as per label leaflet
Season 1-Zone B-Crops as per label leaflet
Season 2-Zone A-Crops as per label leaflet
Season 2-Zone B-Crops as per label leaflet
3. Effect on parasite & predators
Not Required - - - -
4. Translocation in Plants Not Required - - - -
5. Metabolism in Soil Not Required - - - -
6. Metabolism in Water Not Required - - - -
7. Metabolism in Plant Not Required - - - -
8. Persistence in Soil Not Required
9. Persistence in Water Not Required
10. Persistence in Plant Not Required
11. Compatibility with other chemicals if claimed
Not Required
12. Residues in Plant Required Two season data- on each crop as per label leaflet from at least two climatic zone 1.(If file submitted within four years from the date of issue of RTT permit 2. If file is not submitted within stipulated time period then data required on all crops as per label leaflet at the time of submission of file
Season 1-Zone A-Crops as per label leaflet
Season 1-Zone B-Crops as per label leaflet
Season 2-Zone A-Crops as per label leaflet
Season 2-Zone B-Crops as per label leaflet
13. Residues in Soil Not Required - - - -
14. Residue tolerance limit fixed by foreign countries
Not Required - - - -
15. Cost Benefit ratio. Not Required. - - - -
16. Registration status in Foreign countries
Not Required. - - - -
17. Copy of RTT permit Required
18. Form – I Required
19. Label & Leaflets (7 copies) in Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant
Checklist for bio-effectiveness for Technical Indigenous Manufacture (TIM) u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required / Not
Required
Details of data
required
Season and
Location
Whether Data
submitted / Not
submitted
Remarks
1. Bio-efficacy Required Two season / year data Generated at minimum Three agro-climatic conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
2. Phytotoxicity Required Two season / year data Generated at minimum Three agro-climatic conditions.
Season / year – 1 - Location A.
Season / year – 1 -Location B.
Season / year – 1 -Location C.
Season / year – 2 - Location A.
Season / year – 2 - Location B.
Season / year – 2 -Location C.
3. Effect on parasite & predators
Not Required -- -- -- --
4. Translocation in Plants Required
5. Metabolism in Soil Required
6. Metabolism in Water Required
7. Metabolism in Plant Required
8. Persistence in Soil Required
9. Persistence in Water Required
10. Persistence in Plant Required
11. Compatibility with other chemicals if claimed
Not Required -- -- -- --
12. Residues in Plant Not Required -- -- -- --
13. Residues in Soil Not Required -- -- -- --
14. Residue tolerance limit fixed by foreign countries
Not Required -- -- -- --
15. Cost Benefit ratio. Not Required. -- -- -- --
16. Registration status in Foreign countries
Not Required. -- -- -- --
17. Copy of RTT if applicable
Required
18. Form – I Required
19. Label & Leaflets (7 copies) in Hindi & English
Name & Signature of Preliminary Scrutiny Assistant
Checklist for bio-effectiveness for TIM vs TI u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of data
required
Season and
Location
Whether Data
submitted / Not
submitted
Remarks
1. Bio-efficacy Required One season /year data
Generatedat minimum Two agro-climatic
zones on two
representative crops.
One season / year Location 1-Crop A.
One season / year Location 1- Crop B.
One season / year Location 2- Crop A.
One season / year Location 2- Crop B.
2. Phytotoxicity Required One season /year data
Generatedat
minimum Two agro-climatic zones on two
representative crops.
One season / year Location 1-Crop A.
One season / year Location 1- Crop B.
One season / year Location 2- Crop A.
One season / year Location 2- Crop B.
3. Effect on parasite &
predators
Not Required -- -- -- --
4. Translocation in Plants Not Required -- -- -- --
5. Metabolism in Soil Not Required -- -- -- --
6. Metabolism in Water Not Required -- -- -- --
7. Metabolism in Plant Not Required -- -- -- --
8. Persistence in Soil Not Required -- -- -- --
9. Persistence in Water Not Required -- -- -- --
10. Persistence in Plant Not Required -- -- -- --
11. Compatibility with
other chemicals if claimed
Not Required -- -- -- --
12. Residues in Plant Required One season data on
two representative
crop particularly vegetable and fruits.
One season / year -Crop A.
One season / year -Crop B.
13. Residues in Soil Not Required -- -- -- --
14. Residue tolerance limit Not Required -- -- -- --
fixed by foreign
countries
15. Cost Benefit ratio. Not Required. -- -- -- --
16. Registration status in
Foreign countries
Not Required. -- -- -- --
17. Form – I Required
18. Label & Leaflets (7
copies ) in Hindi & English
Required
Name & Signature of Preliminary Scrutiny Assistant
Checklist for bio-efficacy data requirements for registration of combination product of one registered insecticide and one
registered fungicide u/s 9(3)
Sr.
No.
Requirement as per
guidelines
Required /
Not
Required
Details of Data requirement Season and location Whether Data
submitted / Not
submitted
Remarks
1. Bio-effectiveness Required Bio-efficacy evaluation of
insecticide and fungicide alone and
in combination is to be evaluated against insect pest(s) and
disease(s) as per label claim(s)
under different agro-climatic conditions for two seasons.
Season 1-Location A
Season 1-Location B
Season 1-Location C
Season 2-Location A
Season 2-Location B
Season 2-Location C
2. Phytotoxicity Required
3. Persistence in Soil Required If the a.i. content in the
combination product is higher than
the a.i. content of the registered formulation under the Insecticides
Act, the applicant is required to
submit the data.
4. Persistence in Plant Required If the a.i. content in the combination product is higher than
the a.i. content of the registered
formulation under the Insecticides Act, the applicant is required to
submit the data.
5. Persistence in Water Required If the a.i. content in the
combination product is higher than the a.i. content of the registered
formulation under the Insecticides
Act, the applicant is required to submit the data.
6. Compatibility with
other chemicals
Required If the product is proposed to be
mixed with other chemicals, the data on compatibility with these
chemicals are required to be
submitted.
7. Residue in plant Required Season 1 - Location - A
Season 1 - Location - B
Season 1 - Location - C
Season 1 - Location - D
8. Residue in Soil Required Season 1 - Location - A
Season 1 - Location - B
Season 1 - Location - C
Season 1 - Location - D
9. Copy of RTT Required
10. Form – I Required
11. Label & Leaflets (7
copies) in Hindi & English.
Required
Name & Signature of Preliminary Scrutiny Assistant.