1.8
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) as approved in
307th RC held on 24-02-2011
S.No.
A. Chemistry
1.
2.
3.
4.
Parameter
FI (New Source)
Source of Supply
Chemical Composition
Chemical Identity
Physico - Chemical Properties
R
R
R
R
5.
6.
7.
8.
9.
Technical Bulletin
Specification
Method of Analysis
Analytical Test Report
Identification& Quantification of
identifiable Impurities
NR
R
R
R
NR
10a.
10b.
11.
R
R
NR
12c.
Shelf-life
Shelf-life Data
Establishment of Chemical
Equivalence
Process of Manufacture
Information about Raw Materials
Used
Their Source of Supply.
12d.
Step-wise Manufacturing Process.
NR
12e.
12f.
12g.
Chemical Equation
Formula
Flow sheet diagram of process of
manufacture
Effluent Treatment method
NR
NR
NR
Documents such as registration
certificate / manufacturing licence
or any other approval under any
Govt. regulation will be acceptable
to support that manufacturer is
actual producer
R
12a.
12b.
12h.
13.
NR
NR
NR
NR
14.
15.
16.
17.
Certificate from manufacturer that
the dealer/ trader is an authorized
dealer/ trader of the manufacturer
A test report about the 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.
The applicant should provide
sample along- with standards
technical sample from the
principals/ authorized dealers for
chemical verification. In case of
technical grade pesticides,
samples of std. impurities are also
to be provided for chemical
verification. In process sample to
be provided with undertaking
Methodology for residue estimation
as per BBS format.
R
R
R
R
NOTE: Data, except shelf-life, as per the guidelines for Technical Import
under Section 9(3) is also to required be submitted along with the
application.- As per decision of 313th meeting of RC held on 8th Nov., 2010, for
such cases, shelf-life data on technical is required, however, the matter is
under Appeal U/s 10 of the I.A., 1968.
B. Bio-efficacy
18a.
Bioeffectiveness
R**
18b.
Phyto-toxicity
R**
18c.
19.
Effect on parasites & predators
Translocation in plant
R**
NR
20.
21.
22.
23.
24.
25.
26.
Metabolism in soil
Metabolism in water
Metabolism in plant
Persistence in soil
Persistence in water
Persistence in plant
Compatibility with other chemicals,
if claimed
Residues in plant
NR
NR
NR
R
R
R
R
27.
28.
29.
Residues in soil
Residue tolerance limits fixed by
foreign countries
R**
R**
R
30.
Cost benefit ratio
31.
Registration status in foreign
countries
NR
R
R**= Data has to be generated as many number of seasons and locations as per
9(3) FI guidelines
18c= Effect on parasites and predators are not required in case of Fungicides and
Herbicides
Herbicide: For registration of herbicide data on effect on physico-chemical and
biological properties of soil and data on effect on succeeding crops are also
required as per FI u/s.9(3) guidelines of herbicides.
C. Toxicology
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
Acute oral in rat & mice
R
Acute dermal
R
Acute inhalation
R
Primary skin irritation
R
Irritation to mucous membrane
R
Sub-acute oral rat
NR/R
Sub-acute oral dog
NR/R*
Sub-acute dermal
NR/R
Sub-acute inhalation
NR/R
Neuro-toxicity
NR
Synergism & potentiation
NR
Teratogenicity
NR
Effect on reproduction
NR
Carcinogenicity
NR
Metabolism
NR
Mutagenicity
NR
Toxicity to birds
R
Toxicity to fish
R
Toxicity to honeybees
R
Toxicity to live stock
NR
Medical data
R
Human toxicity information from
NR
foreign countries
Observation in man (Health records NR (reference 318th RC held on
of spray operators)
27-04-2011)
Health records of Industrial
R
workers.
Toxicity to live stock (Field trial &
NR (reference 318th RC held on
observation)
27-04-2011)
International report on
NR
carcinogenicity & geno-toxicity
status
D. Packaging
58.
59
a.
b.
c.
d.
e.
f.
g.
60.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
61.
62.
63.
64.
65.
66.
67.
Labels and leaflets as per IR1971 existing norms (i) for size
250 ml & below (ii) for 500 &
above.
Labels to contents
Detailed Chemical composition
Purpose for import / manufacture.
Antidote
Toxicity triangle
Cautionary statement
Brief direction concerning usages
Restriction, if any
Leaflets to contain
Detailed Chemical composition on
leaflets accompanying small
labels (upto 250 ml size
container)
Introductory para about the
pesticide
Detailed directions concerning
usages
Time of application
Application equipment
Waiting Period
Symptoms of poisoning
First aid measures
Antidote & treatment
Restriction, if any
Instruction for storage
Information regarding disposal of
used packages.
Type of packaging (pkg material +
compa-tibility with content)
Manner of packaging
Specification for primary package
Specification for secondary
packaging.
Specification for transport
packaging.
Manner of labeling
Performance of container during
storage stability test
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
Abbreviations :
R :
Required
FI : Formulation Import
NR : Not required
TI : Technical Import
R*: Any peer reviewed published data/information shall be acceptable (approved in 343rd and 344th RC
Meeting)
Note :
1.
As per the Directives of Department of Agriculture & Cooperation, Ministry of
Agriculture letters no. 17-2/2006-PP.I dated October 30, 2007 and 18.2.2008,
respectively, in case of registration of formulation for import without registering
technical, the technical shall deemed to be registered without separate
application or evaluation after expiry of 3 years from the date of registration of the
formulation. Where registration shall be granted for formulations under Section 9
(3B) with commercialization, the period of three years shall be computed from the
date of grant of registration with commercialization.
2.
Data on Technical :
If time gap after first registration of formulation import without registration of
technical has been less than 3 years, required to submit the data on Technical as
per the requirement of TI U/S.9(3). However, after 3 years, required to submit
the data on technical as per the guidelines of TI (new source) or TI vs TIM as the
case may be.
3.
PGR
Data requirements of chemical pesticides are also applicable for chemical Plant
Growth Regulators.