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1.1.

1
GUIDELINES / DATA REQUIREMENTS FOR REGISTRATION OF
HERBICICIDES U/s 9(3) / 9(3B) / 9(4) as on 05-10-2011
Abbreviations :
:

Required

NR

TIM

Technical Indigenous
Manufacture

TI

FI

Formulation Import

FIM

IM
AR

:
:

Indigenous Manufacture
Already Registered

NF

Not Required
Technical Import
Formulation Indigenous
Manufacture
New Formulation

Note:
(i) For Import of Formulation u/s 9(3):
(ia) If the applicant does not seek registration for import of technical together with formulation in such a
case the applicant shall be required to submit complete data as per the requirement of technical
Import in addition to formulation import. The Deemed Registered Status of technical in

such cases shall come into force only after expiry of 3 years from the date of
registration of its formulation for import and that the norm shall be applicable to all
the formulations which are already registered for import without registering the
technical; and in cases where registration granted for formulations under Section
9(3B) with commercialization, the period of three years for effecting the deemed
registration of technical will be computed from the date of issuing registration for
formulation under Section 9(3B) with commercialization. The requirements of data
on technical w.r.t. shelf-life & informations on packaging, as per decision of 313 th RC
held 8th Nov., 2010, are under Appeal U/s 10 of the Insecticides Act, 1968.
.

(ib) Rationale for importing formulation.

(ii) If the applicant does not seek registration for indigenous manufacture of technical
together with Formulation, in such a case the applicant shall be required to submit
complete data as per the requirement of Technical Indigenous Manufacture in addition
to formulation indigenous manufacture subject to fulfillment of condition that the
technical and formulation products will be manufactured in the same premises.
Deemed registration status of technical shall come into force after expiry of three years
from registration of formulation for indigenous manufacture without registration of
technical U/s 9(3) and other conditions regarding submission of data on shelf-life &
information on packaging etc. shall be same as for the cases for import of formulation
without registration of technical (As per decisions of 272nd (17-01-2007) & 314th
(24/27-01-2011) RC meetings.
(iii) Data requirements of chemical pesticides are also applicable for registration of
chemical plant growth regulators (PGR).

S.
No.

9(3B)

Parameter

TI

9(3)

TI
M

FI
M

TI

TI
M

FI

9(4)

FI
M

TI
Vs
TI
M

TI
M
Vs
TI

TI
(Ne
w

10

11

12

NF**
(IM)

Sourc
e)

TIM*
(AR)
Vs
TI

A.

Chemistry

1.

Source of Supply of
Technical

NR

NR

NR

NR

2.

Chemical Composition

3.

Chemical Identity of
technical

4.

Physico - Chemical
Properties of adjuvants

5.

Technical Bulletin

NR

NR

NR

NR

NR

NR

6.

Specification

7.

Method of Analysis

8.

Analytical Test Report

9.

Identification&
Quantification of
identifiable Impurities

NR

NR

NR

NR

NR

NR

10a.

Shelf-life clRm

10b.

Shelf-life Data

NR

NR

NR

NR

11.

Establishment of
Chemical Equivalence

NR

NR

NR

NR

NR

NR

NR

NR

NR

12a.

Process of Manufacture

NR

NR

NR

NR

NR

12b.

Information about Raw


Materials Used

NR

NR

NR

NR

NR

12c.

Their Source of Supply.

NR

NR

NR

NR

NR

12d.

Step-wise Manufacturing NR
Process.

NR

NR

NR

NR

12e.

Chemical Equation

NR

NR

NR

NR

NR

NR

NR

NR

12f.

Formula

NR

NR

NR

NR

NR

NR

NR

NR

12g.

Flow sheet diagram of


process of manufacture

NR

NR

NR

NR

NR

12h.

Effluent Treatment
method

NR

NR

NR

NR

NR

13.

Documents such as
registration certificate /
Certificate of
DNA/manufacturing
licence or any other

NR

NR

NR

NR

NR

NR

NR

approval under any Govt.


regulation will be
acceptable to support that
manufacturer is actual
producer
14.

Certificate from
manufacturer that the
dealer/ trader is an
authorized dealer/ trader
of the manufacturer.

NR

NR

NR

NR

NR

NR

NR

NR

15.

A test report about the


R
quality of the product
from a laboratory as per
GLP scheme or from a
company of ISO-9000.
This requirement will be
provided along with first
consignment. Thereafter,
each consignment should
have proper analytical
test report of the
manufacturer.

NR

NR

NR

NR

NR

NR

NR

NR

16.

The applicant should


R
provide sample along
with standards technical
sample from the
principals/ authorized
dealers for chemical
verification. In case of
technical grade pesticides
u/s 9(3), samples of std.
impurities are also to be
provided for chemical
verification. In process
sample to be provided in
case of indigenous
manufacture of technical
u/s 9(3) TIM & 9(4) TIM
with undertaking

17.

Methodology for residue R


estimation as per BIS
format.

NR

B.

BIOEFFICACY-

As approved in 291st RC extended meeting


held on 28-07-2008

18a.

Bio-effectiveness

NR

NR

R*

NR

R**

R**

R**

R+

R+

R++

R**

NR

18b.

Phytotoxicity

NR

NR

R*

NR

R**

R**

R**

R+

R+

R++

R**

NR

19.

Translocation in plants

NR

NR

NR

NR

NR

NR

NR

NR

20.

Metabolism in soil

NR

NR

NR

NR

NR

NR

NR

NR

21.

Metabolism in water

NR

NR

NR

NR

NR

NR

NR

NR

22.

Metabolism in plant

NR

NR

NR

NR

NR

NR

NR

NR

23.

Persistence in soil

NR

NR

NR

NR

24.

Persistence in water

NR

NR

NR

NR

25.

Persistence in plant

NR

NR

NR

NR

26.

Compatibility with other


chemicals

NR

NR

R#

NR

NR

R#

R#

NR

NR

NR

NR

27.

Residues in plant

NR

NR

R*

NR

NR

R**

R**

R^

R^

R++

R**/
NR

NR

28.

Residues in soil

NR

NR

R*

NR

NR

R**

R**

NR

NR

NR

NR

NR

29.

Residue tolerance limits


fixed by foreign
countries

NR

NR

NR

NR

NR

NR

NR

NR

30.

Cost benefit ratio

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

31.

Registration status in
foreign countries

NR

NR

NR

NR

NR

NR

R*

: Two seasons/years data generated at minimum two agroclimatic


conditions/locations+

R**

Two seasons/years data generated at minimum three agroclimatic


conditions/locations+
Locations+ : Locations shall be applicable for the crops for which required agroclimatic conditions are not avRlable.

R #: Data on compatibility is required, if the product is proposed to mix with other


chemicals.
Notes:
(i)

In case of herbicides data on effect on soil physico-chemical and biological


properties, and effect on normally cultivated three succeeding crops is
required along with residue studies in the same plots of the field.

Example: For a herbicide intended to be registered for use in wheat crop data on
effect on succeeding crops of mRze at location 1, green gram at location 2,
sesamum at location 3, may be generated along with residue studies. However,
this is only an example and data on any other normally cultivated succeeding
crop may be generated.)
(ii)

(iii)

For the requirement of data on translocation in plants, International data from


any authentic source shall be accepted.
R+ : In case of TIM Vs TI and TI Vs TIM under section 9(3), one season data
on bioefficacy including phytotoxicity, if any, on two representative crops at
two climatic zones is required to be submitted.

(iv) R^ : One season residue data on two representative crops particularly on fruits
and vegetables is required in case of TIM Vs TI and TI Vs TIM under section
9(3).

(V) R++: In case of TI (New Source) two seasons data on each crop mentioned in labels/ leaflets
at least at two Climatic Zones required on bio-effectiveness and phytotoxicity and two
years or seasons data on Residues in plant on representative crops of each group on
which pesticide is approved.
NOTE: Data on Bioeffectiveness & Phyto-toxicity to be submitted on all registered
formulations of same technical as per RC guidelines on all approved crops at the time of
issue of import permit provided the application for registration is received within 4 years of
issue of import Permit as per the decision of 313 th meeting of RC held on 8th Nov, 2010.
TIM*(AR) Vs TI U/s 9(4): If chemical equivalence fRls in the sample submitted by the applicant / inprocess samples, required to submit data on bioefficacy as per the guidelines for TIM vs
TI U/s 9(3)
C.

TOXICITY

32.

Acute oral in rat & mice

33.

Acute dermal

34.

Acute inhalation

NR

35.

Primary skin irritation

36.

Irritation to mucous
membrane

37.

Sub-acute oral rat

NR/
R

NR/
R

NR/
R

NR

NR

NR/R

NR

38.

Sub-acute oral dog

R*

R*

NR/
R*

R*

R*

NR/
R*

NR/
R*

NR

NR

R*

NR/
R*

NR

39.

Sub-acute dermal

NR/
R

NR/
R

NR/
R

NR

NR

NR/R

NR

40.

Sub-acute inhalation

NR/
R

NR/
R

NR/
R

NR

NR

NR/R

NR

41.

Neuro-toxicity

NR

NR

NR

NR/
R

NR/
R

NR

NR

NR

NR/R

NR

42.

Synergism &
potentiation

NR

NR

NR

NR/
R

NR/
R

NR

NR

NR

NR

NR

43.

Teratogenicity

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

44.

Effect on reproduction

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

45.

Carcinogenicity

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

46.

Metabolism

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

47.

Mutagenicity

NR

NR

NR

NR

NR

NR/
R

NR/
R

NR

NR

48.

Toxicity to birds (two)

NR

NR

NR

NR

49.

Toxicity to fish (fresh


water)

NR

NR

NR

NR

50.

Toxicity to honeybees

NR

NR

NR

NR

51.

Toxicity to live stock

NR

NR

NR

NR

NR

NR

NR

52.

Medical data

NR

53.

Human toxicity
R
information from foreign
countries

NR

NR

NR

NR

NR

NR

NR

54.

Observation in man
(Health records of spray
operators)

NR

NR

NR

NR

NR

NR^
^

NR^
^

NR

NR

NR

NR^^

NR

55.

Health records of
Industrial workers.

NR

NR

NR

NR

NR

NR

NR

NR

56.

Toxicity to live stock


(Field trial &
observation)

NR

NR

NR

NR

NR

NR^
^

NR^
^

NR

NR

NR

NR

NR

57.

International report on
carcinogenicity &
genotoxicity status

NR

NR

NR

R/N
R

R/N
R

NR

NR

NR

NR

NR

NR

NR

NR^^: Not required as per decision of 318th RC held on 27-04-2011

NF** : In case of wettable powder, if toxicological data is generated for EC formulation


applicable as per guidelines, then there is no need to generate data on wettable
powder contRning the same a.i.

TIM*(AR) Vs TI U/s 9(4): If chemical equivalence fRls in the sample submitted by the applicant / inprocess samples, required to submit data on toxicity as per the guidelines for TIM vs TI U/s
9(3)
R*: Any peer reviewed published data/information shall be acceptable (approved in 343 rd and 344th RC
Meeting)
D.

PACKAGING

58.

Labels and leaflets as per R


IR-1971 existing norms
(i) for size 250 ml &
below (ii) for 500 &
above.

59

Labels to contents

a.

DetRled Chemical
composition

b.

Purpose for import /


manufacture.

c.

Antidote

d.

Toxicity triangle

e.

Cautionary statement

f.

Brief direction
concerning usages

g.

Restriction if any

60.

Leaflets to contRn

a.

DetRled Chemical
composition on leaflets
accompanying small
labels (upto 250 ml size
contRner)

NR

NR

NR

NR

NR

NR

NR

b.

Introductory para about


the pesticide

c.

DetRled directions
concerning usages

NR

NR

NR

NR

NR

NR

NR

NR

d.

Time of application

NR

NR

NR

NR

NR

NR

NR

NR

e.

Application equipment

NR

NR

NR

NR

NR

NR

NR

NR

f.

WRting Period

NR

NR

NR

NR

NR

NR

NR

NR

g.

Symptoms of poisoning

h.

First Rd measures

i.

Antidote & treatment

j.

Restriction, if any

k.

Instruction for storage

l.

Information regarding
disposal of used
packages.

61.

Type of packaging (pkg


material + compatibility
with content)

NR

62.

Manner of packaging

62.1

Specification for primary R


package

62.2

Specification for
secondary packaging.

62.3

Specification for
transport packaging.

63.

Manner of labelling

NR

NR

NR

64.

Performance of contRner NR
during storage stability
test

NR

NR

NR

65

Transport worthiness test NR

NR

NR