Checklist for Bio-efficacy data requirement for registration of … · 2020. 9. 11. · Checklist for Bio-efficacy data requirement for registration of already registered formulations

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 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.


Required /

Not

Required

Details of Data

requirement


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.


Required /

Not

Required

Details of Data

requirement


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


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


8. Copy of RTT if

applicable

Required

9. Form - I Required

10. Label & Leaflets (7

copies) in Hindi &

English

Required


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 B.


2. Phytotoxicity Required Two season / year data

Generated

at minimum Three agro-climatic

conditions.







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


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


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


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.







2. Phytotoxicity Required Two season / year data

Generated

at minimum Three agro-climatic

conditions.








predators

Not Required -- --

--

--

--

--

-- 4. Translocation in Plants Not Required -- -- -- --








other chemicals if

claimed

Required

12. Residues in Plant Required One season/ year data generated at

minimum four Agro


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





18. MRL Proforma in

duplicate with CD

Required

19. Label & Leaflets 97

copies) in Hindi &

English

Required


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.


Required /

Not Required

Details of Data

requirement


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


19. Label & Leaflets (7 copies) in Hindi

& English

Required


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


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 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 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 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


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.


Required /

Not Required

Details of Data

requirement


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


ii) Required for vegetable crops and crops where young seedlings are


5. Persistence in soil

Required


ii) Required for vegetable crops and crops where young seedlings are


6. Persistence in water:

Required


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



Required


Checklist for bio-effectiveness for Technical Import u/s 9(3)

Sr.

No.


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




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. -- --


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



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






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





13. Residues in Soil Not Required - - - -

14. Residue tolerance limit fixed by foreign countries

Not Required - - - -

15. Cost Benefit ratio. Not Required. - - - -


Not Required. - - - -




Required


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.







2. Phytotoxicity Required Two season / year data Generated at minimum Three agro-climatic conditions.








Not Required -- -- -- --

4. Translocation in Plants Required

5. Metabolism in Soil Required

6. Metabolism in Water Required

7. Metabolism in Plant Required




11. Compatibility with other chemicals if claimed


12. Residues in Plant Not Required -- -- -- --

13. Residues in Soil Not Required -- -- -- --

14. Residue tolerance limit fixed by foreign countries





17. Copy of RTT if applicable

Required




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.


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 2- Crop A.



predators


4. Translocation in Plants Not Required -- -- -- --




8. Persistence in Soil Not Required -- -- -- --

9. Persistence in Water Not Required -- -- -- --

10. Persistence in Plant Not Required -- -- -- --


other chemicals if claimed


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


16. Registration status in

Foreign countries




copies ) in Hindi & English

Required


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


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.


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



copies) in Hindi & English.

Required


Documents

Checklist for Bio-efficacy data requirement for registration of … · 2020. 9. 11. · Checklist for Bio-efficacy data requirement for registration of already registered formulations