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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.
.
(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.
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.
NR
NR
NR
NR
NR
12c.
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.
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
Certificate from
manufacturer that the
dealer/ trader is an
authorized dealer/ trader
of the manufacturer.
NR
NR
NR
NR
NR
NR
NR
NR
15.
NR
NR
NR
NR
NR
NR
NR
NR
16.
17.
NR
B.
BIOEFFICACY-
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.
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.
NR
NR
NR
NR
NR
NR
NR
NR
30.
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*
R**
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)
(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.
33.
Acute dermal
34.
Acute inhalation
NR
35.
36.
Irritation to mucous
membrane
37.
NR/
R
NR/
R
NR/
R
NR
NR
NR/R
NR
38.
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.
NR
NR
NR
NR
49.
NR
NR
NR
NR
50.
Toxicity to honeybees
NR
NR
NR
NR
51.
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.
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
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.
59
Labels to contents
a.
DetRled Chemical
composition
b.
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.
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.
j.
Restriction, if any
k.
l.
Information regarding
disposal of used
packages.
61.
NR
62.
Manner of packaging
62.1
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
NR
NR