1.1.1
GUIDELINES / DATA REQUIREMENTS FOR REGISTRATION OF
HERBICICIDES U/s 9(3) / 9(3B) / 9(4) as on 05-10-2011
Abbreviations :
:
R
:
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).
1
S.
No.
9(3B)
Parameter
TI
1
2
9(3)
TIM FIM TI
3
4
5
TIM FI
6
7
FIM
8
9(4)
TI
TIM TI
Vs
Vs
(New
Source)
TIM TI
9
10
11
NF**
(IM)
TIM
*
(AR)
Vs
TI
12
A.
Chemistry
1.
Source of Supply of
Technical
R
NR
R
R
NR
R
R
R
NR
R
R
NR
2.
Chemical Composition
R
R
R
R
R
R
R
R
R
R
R
R
3.
Chemical Identity of
technical
R
R
R
R
R
R
R
R
R
R
R
R
4.
Physico - Chemical
Properties of adjuvants
R
R
R
R
R
R
R
R
R
R
R
R
5.
Technical Bulletin
R
NR
NR
R
NR
R
NR
R
NR
R
R
NR
6.
Specification
R
R
R
R
R
R
R
R
R
R
R
R
7.
Method of Analysis
R
R
R
R
R
R
R
R
R
R
R
R
8.
Analytical Test Report
R
R
R
R
R
R
R
R
R
R
R
R
9.
Identification&
Quantification of
identifiable Impurities
NR
NR
NR
R
R
NR
NR
R
R
R
NR
R
10a.
Shelf-life clRm
R
R
R
R
R
R
R
R
R
R
R
R
10b.
Shelf-life Data
NR
NR
NR
R
R
R
R
R
R
R
R
NR
11.
Establishment of
Chemical Equivalence
NR
NR
NR
NR
NR
NR
NR
R
R
NR
NR
R
12a.
Process of Manufacture
NR
R
R
NR
R
NR
R
NR
R
NR
R
R
12b.
Information about Raw
Materials Used
NR
R
R
NR
R
NR
R
NR
R
NR
R
R
12c.
Their Source of Supply. NR
R
R
NR
R
NR
R
NR
R
NR
R
R
12d.
Step-wise
Manufacturing Process.
NR
R
R
NR
R
NR
R
NR
R
NR
R
R
12e.
Chemical Equation
NR
R
NR
NR
R
NR
NR
NR
R
NR
NR
R
12f.
Formula
NR
R
NR
NR
R
NR
NR
NR
R
NR
NR
R
12g.
Flow sheet diagram of
process of manufacture
NR
R
R
NR
R
NR
R
NR
R
NR
R
R
12h.
Effluent Treatment
method
NR
R
R
NR
R
NR
R
NR
R
NR
R
R
13.
Documents such as
registration certificate /
Certificate of
DNA/manufacturing
R
NR
NR
R
NR
R
NR
R
NR
R
NR
NR
2
licence or any other
approval under any
Govt. regulation will be
acceptable to support
that manufacturer is
actual producer
14.
Certificate from
R
manufacturer that the
dealer/ trader is an
authorized dealer/ trader
of the manufacturer.
NR
NR
R
NR
R
NR
R
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
R
NR
R
NR
R
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
R
R
R
R
R
R
R
R
R
R
R
17.
Methodology for residue R
estimation as per BIS
format.
R
R
R
R
R
R
R
R
R
R
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
R
R
NR
R
R
NR
NR
NR
NR
NR
NR
NR
3
20.
Metabolism in soil
R
R
NR
R
R
NR
NR
NR
NR
NR
NR
NR
21.
Metabolism in water
R
R
NR
R
R
NR
NR
NR
NR
NR
NR
NR
22.
Metabolism in plant
R
R
NR
R
R
NR
NR
NR
NR
NR
NR
NR
23.
Persistence in soil
R
R
R
R
R
R
R
NR
NR
NR
R
NR
24.
Persistence in water
R
R
R
R
R
R
R
NR
NR
NR
R
NR
25.
Persistence in plant
R
R
R
R
R
R
R
NR
NR
NR
R
NR
26.
Compatibility with other NR
chemicals
NR
R#
NR
NR
R#
R#
NR
NR
NR
R
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 NR
fixed by foreign
countries
NR
R
NR
NR
R
R
NR
NR
NR
R
NR
30.
Cost benefit ratio
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
31.
Registration status in
foreign countries
R
NR
R
R
NR
R
R
NR
NR
NR
R
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)
For the requirement of data on translocation in plants, International data from
any authentic source shall be accepted.
(iii) 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
4
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 313th 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 R
R
R
R
R
R
R
R
R
R
R
R
33.
Acute dermal
R
R
R
R
R
R
R
R
R
R
R
R
34.
Acute inhalation
R
R
R
R
R
R
R
R
R
R
R
NR
35.
Primary skin irritation
R
R
R
R
R
R
R
R
R
R
R
R
36.
Irritation to mucous
membrane
R
R
R
R
R
R
R
R
R
R
R
R
37.
Sub-acute oral rat
R
R
NR/R R
R
NR/R NR/R NR
NR
R
NR/
R
NR
38.
Sub-acute oral dog
R*
R*
NR/
R*
R*
NR/
R*
NR
NR
R*
NR/
R*
NR
39.
Sub-acute dermal
R
R
NR/R R
R
NR/R NR/R NR
NR
R
NR/
R
NR
40.
Sub-acute inhalation
R
R
NR/R R
R
NR/R NR/R NR
NR
R
NR/
R
NR
41.
Neuro-toxicity
NR
NR
NR
R
R
NR/R NR/R NR
NR
NR
NR/
R
NR
42.
Synergism &
potentiation
NR
NR
NR
R
R
NR/R NR/R NR
NR
NR
NR
NR
43.
Teratogenicity
NR
NR
NR
R
R
NR
NR
NR
NR
NR
NR
NR
44.
Effect on reproduction
NR
NR
NR
R
R
NR
NR
NR
NR
NR
NR
NR
45.
Carcinogenicity
NR
NR
NR
R
R
NR
NR
NR
NR
NR
NR
NR
46.
Metabolism
NR
NR
NR
R
R
NR
NR
NR
NR
NR
NR
NR
47.
Mutagenicity
NR
NR
NR
R
R
NR
NR
NR/R NR/R R
NR
NR
48.
Toxicity to birds (two)
R
R
R
R
R
R
R
NR
NR
R
NR
NR
49.
Toxicity to fish (fresh
water)
R
R
R
R
R
R
R
NR
NR
R
NR
NR
50.
Toxicity to honeybees
R
R
R
R
R
R
R
NR
NR
R
NR
NR
R*
NR/
R*
5
51.
Toxicity to live stock
R
R
NR
R
R
NR
NR
NR
NR
R
NR
NR
52.
Medical data
R
R
R
R
R
R
R
R
R
R
NR
R
53.
Human toxicity
R
information from foreign
countries
R
R
R
NR
NR
NR
NR
NR
R
NR
NR
54.
Observation in man
NR
(Health records of spray
operators)
NR
NR
NR
NR
NR^^ NR^^ NR
NR
NR
NR^^
NR
55.
Health records of
Industrial workers.
NR
NR
NR
R
NR
R
NR
R
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/NR R/NR NR
NR
NR
NR
NR
NR
NR
R
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 343rd and 344th RC
Meeting)
D.
PACKAGING
58.
Labels and leaflets as
R
per IR-1971 existing
norms (i) for size 250 ml
& below (ii) for 500 &
above.
R
R
R
R
R
R
R
R
R
R
R
59
Labels to contents
R
R
R
R
R
R
R
R
R
R
R
R
a.
DetRled Chemical
composition
R
R
R
R
R
R
R
R
R
R
R
R
b.
Purpose for import /
manufacture.
R
R
R
R
R
R
R
R
R
R
R
R
c.
Antidote
R
R
R
R
R
R
R
R
R
R
R
R
d.
Toxicity triangle
R
R
R
R
R
R
R
R
R
R
R
R
e.
Cautionary statement
R
R
R
R
R
R
R
R
R
R
R
R
f.
Brief direction
concerning usages
R
R
R
R
R
R
R
R
R
R
R
R
g.
Restriction if any
R
R
R
R
R
R
R
R
R
R
R
R
60.
Leaflets to contRn
a.
DetRled Chemical
composition on leaflets
NR
NR
R
NR
NR
NR
R
R
R
NR
R
NR
6
accompanying small
labels (upto 250 ml size
contRner)
b.
Introductory para about
the pesticide
R
R
R
R
R
R
R
R
R
R
R
R
c.
DetRled directions
concerning usages
NR
NR
R
NR
NR
R
R
NR
NR
NR
R
NR
d.
Time of application
NR
NR
R
NR
NR
R
R
NR
NR
NR
R
NR
e.
Application equipment
NR
NR
R
NR
NR
R
R
NR
NR
NR
R
NR
f.
WRting Period
NR
NR
R
NR
NR
R
R
NR
NR
NR
R
NR
g.
Symptoms of poisoning
R
R
R
R
R
R
R
R
R
R
R
R
h.
First Rd measures
R
R
R
R
R
R
R
R
R
R
R
R
i.
Antidote & treatment
R
R
R
R
R
R
R
R
R
R
R
R
j.
Restriction, if any
R
R
R
R
R
R
R
R
R
R
R
R
k.
Instruction for storage
R
R
R
R
R
R
R
R
R
R
R
R
l.
Information regarding
disposal of used
packages.
R
R
R
R
R
R
R
R
R
R
R
R
61.
Type of packaging (pkg R
material + compatibility
with content)
R
R
R
R
R
R
R
R
R
R
NR
62.
Manner of packaging
R
R
R
R
R
R
R
R
R
R
R
R
62.1
Specification for
primary package
R
R
R
R
R
R
R
R
R
R
R
R
62.2
Specification for
secondary packaging.
R
R
R
R
R
R
R
R
R
R
R
R
62.3
Specification for
transport packaging.
R
R
R
R
R
R
R
R
R
R
R
R
63.
Manner of labelling
NR
R
R
NR
R
NR
R
R
R
R
R
R
64.
Performance of
NR
contRner during storage
stability test
NR
NR
R
R
R
R
R
R
R
R
NR
65
Transport worthiness
test
NR
NR
R
R
R
R
R
R
R
R
R
NR
7
8