Annexure-I
GUIDELINES FOR DEALING APPLICATIONS FOR REGISTRATION UNDER
EXPORT ONLY CATEGORY AS APPROVED BY THE RC IN 347TH MEETING
I. GENERAL
1. The accreditation of Star Export Houses shall be on the same basis as that of the
Ministry of Commerce and the fee shall also be charged accordingly. eapplications would, however, be accepted after development of relevant software.
2. The times lines for export registration under already registered category in case of
complete applications shall be on RC-to-RC basis, wherein the applications
received till the date of closing of agenda shall be considered in the ensuing
meeting. The period for unregistered products shall be three months as the
applications are also to be examined from toxicological angle. The period for
registration under Star Export House category shall be a fortnight from the date of
receipt of applications.
3. The Technical substance(s) and their formulations which have already been
approved once by the RC exclusively for exports, these should be included in the
proposed Category IV (presently known as Category III) for subsequent
registrations exclusively for exports. However, it would commence into force
after development of proper database and related software with respect to
Certificates of registration and Labels & Leaflets.
4. In case the product is registered for domestic use, a condition in the certificate of
registration can be stipulated as “In case of the consignments of the product for
export purpose, the primary packaging may be as per the requirement of the
importing country”.
5. Deficiencies may be communicated to the applicant through E-mail in case the
applicant has provided e-mail ids in Form-I in Cl. 1 under the address as the
additional information.
6. Minor corrections, e.g., in label and leaflets etc., may be allowed to be done by
authorized company representatives in person on any of the visiting hours on
visiting days in the presence of expert concerned.
7.
A condition in case of Microbial Biopesticides and Botanical Biopesticides,
respectively, shall be incorporated in the certificates of registrations for export
category:“The product being exported is in compliance of Biological Diversity Act, 2002.”
This condition shall also be applicable in respect of the certificates of registrations
already issued.
8. A list of exporters company-wise, product-wise and country export-wise may be
maintained in the Sectt. of CIB & RC and the share of Star-Export Houses in total
export shall also be maintained future guidance on policy. Necessary amendment
in the relevant provision(s) of the Insecticides Rules, 1971 making it mandatory
for the registrants to provide export-related information, like the list of exporters
company-wise, product-wise and country export-wise shall be made accordingly.
9. A Standing Expert Committee to review/analyse the use and misuse of pesticides
in terms of ethics and health, environment, ecology & economy securities shall
also be constituted.
II. SPECIFIC
Guidelines for Registration of Pesticides Exclusively for Export
(Refer to Categories at (A) and Requirements at (B) Mentioned Below)
(A)
Categories of Pesticides for Export Registration
Category – I
Import of technical grade pesticide, which is not registered for manufacture
/Import and use in India, for the sole purpose of Export either as technical
itself or after converting it into formulation(s).
Category – II
Import of technical grade pesticide, which is registered for
manufacture/Import and use in India, for the sole purpose of Export either as
technical itself or after converting it into formulation(s). Import under this
category shall be permitted only from a source approved by the Registration
Committee.
.
Category-III
Indigenous manufacture of technical grade pesticide, which is not registered
for use in India.
Category – IV
Indigenous manufacture of pesticide [technical grade with same or different
impurity profile or formulation(s) of same, lower or higher concentration with
same or different adjuvant including new type of formulation(s)] already
registered for use in India (without altering the active ingredients) for the sole
purpose of export.
Category - V
Indigenous manufacture of new pesticide formulation(s), not registered for
manufacture and use in the country, for the sole purpose of export. In case of
formulation made from technical grade pesticide, which is not registered for
use in India, separate application for import/manufacture of technical grade
pesticide is also required to be submitted.”
Category – VI
New combination pesticide formulation, not registered for use in India. In
case of unregistered technical grade pesticide(s), separate application(s) is
required to be submitted for registration thereof.
Category – VII
Import of new formulation of pesticide (not registered for import/manufacture
and use in India) for the sole purpose of export (In case of formulation made
from technical which is registered for use in India, import from approved
source of technical only).
Category – VIII
Indigenous manufacture of registered/unregistered formulation of microbial
biopesticides.
Category –VIII (a)
Bio-pesticides: non-Bt & Bs based
Category –VIII (b)
Bio-pesticides: Bt & Bs based.
Category IX
Indigenous manufacture of bio-pesticide--Botanical - technical/ formulation
(registered/ unregistered).”
(B)
Information/Data Requirements for Grant of Registration of Pesticide
Exclusively for Export
(Refer Table 1 To 5)
I. Chemistry Requirements (Category I to IX, Table 1 to 3)
:Table 1:
(a) Information/data requirements for grant of registration of chemical pesticides
exclusively for export (Category I to VII)
Sl.
No.
Parameter
1.
2.
3.
Chemical composition
Physico-chemical properties
Specification in BIS format along with
undertaking for product quality
Method of analysis
Outline of process of manufacture, raw
materials used / process of extraction of
active ingredient
Source of import
4.
5.
6.
Category
I
II
III
IV
V
VI
VII
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
NR
R
NR
R
R
R
R
R
R
R
R
R
NR
R
R
NR
NR
R
R
R
:Table 2:
(b) Information/Data requirements for grant of registration of microbial Bio-pesticide
exclusively for export (Category VIII)
Sl.
No.
1.
Category – VIII
Scientific name, common name, if any, and place of
origin in the country.
Specify the microbial strain for the given biological
activity and its location of existence in India.
Composition of the product with percentage
of all
ingredients.
Specification of the product along with undertaking that
the product is naturally occurring and not genetically
engineered.
Outline of process of manufacture, raw material
used/process of extraction of active ingredient.
Method of analysis
R
Formulatio
n
R
R
R
R
R
R
R
R
R
a.
Determination of toxin contents using the internationally
recognised scientific methods & Standard Operating
procedures in accredited and recognised laboratories
only for Bacillus sphaericus (B.s) & Bacillus
thuringiensis / similar products
R
R
b.
Determination of potency by bioassay method
R
R
R
R
2.
3.
4.
5.
6.
c.
OR
Determination of Colony Forming
Polyhedral Occlusion Bodies(POB)
appropriate method
Technical
Units(CFU)/
counts by
Table 3:
(c) Information/Data requirements for grant of registration of Botanical Bio-pesticide
exclusively for export (Category - IX)
Sl.
No.
Category – IX
Technical
Formulation
1.
Botanical name, common name of the plant and place of
origin in the country.
Specify the plant part for the given biological activity.
Chemical composition and physico-chemical properties.
Specification of the product along with the undertaking
that the product is naturally occurring and not genetically
engineered.
Specification in BIS format* along with undertaking for
the product quality.
Outline of process of manufacture, raw materials
used/process of extraction of active ingredient.
Method of analysis
Determination of active ingredient by appropriate method
R
R
R
R
R
R
R
R
R
R
R
R
R
R
2.
3.
4.
5.
6.
7.
*If no information on certain minor parameters is available the applicant should indicate so
and it should be accepted.
II. Toxicology Requirements (Category I to IX, Table 4 to 5)
Table 4:
(a) Toxicology information/data requirements for grant of registration of pesticide
exclusively for export [Category I to VII, VIII(a) & IX]
Sl.
No.
Parameter
CATEGORY
I
II
II
I
IV
V
VI
VII
++
+
VIII(a) (Microbials)
Regd.@
strain/
product
1.
2.
3.
4.
5.
6.
IX
(Botanicals)
NonRegd.
Nonregd. Product Regd
Strain/
Product
product
Acute Oral
rat
Acute dermal
R
N
R
R
N
R
R+
++/R
+
R
NR
R
NR
R
R
R
NR
R
NR
R
R+
++/R
+
R+
R
R
N
R
N
R
R+
Acute
inhalation
Primary skin
irritation
Irritation to
mucous
membrane
Effect on
N
R
N
R
R
NR
R
NR
R
R
N
R
R
N
R
R+
R+
R
NR
R
NR
R
R
N
R
R
N
R
R+
R+
R
NR
R
NR
R
R
N
R
N
N
NR
NR
NR
NR
NR
NR
R
7.
8.
9.
reproduction
Development
al Toxicity
Carcinogenic
ity
Mutagenicity
R
R
N
R
R
R
N
R
R
N
R
NR
NR
NR
NR
NR
NR
R
N
R
R
N
R
N
R
NR
NR
NR
NR
NR
NR
R
N
R
N
R
R
N
R
N
R
N
R
N
R
NR
NR
NR
NR
NR
R**
R
R
NR
NR
NR
NR
NR
NR
Neurotoxicit
y
R
R* R
R* R* R*
R* R*
R*
R*
R*
11. Signs and
*
*
symptoms of
poisoning
and
treatment,
first aid and
precautionar
y measures
Published information on these parameters shall be acceptable from any of the following
sources:
10.
i)
ii)
From the reviews undertaken by International organization/institutions like WHO,
Joint bodies of FAO/WHO, International Registry for Potential Toxic Chemicals
(IRPTC), International Agency on Research on Cancer (IARC), etc.
Any evaluation / Fact Sheet by Registration authorities of USA or EU or Canada or
Japan including Material Safety Data Sheet shall be accepted. Information from other
reliable sources including TOXNET, EXTONET can be provided.
+ If published information is not available data are to be submitted
++ The calculations using WHO formula for conversion of acute LD50 values of technical
grade pesticides (which are components of a combination product) into the predicted acute
LD50 value of that combination shall be applicable provided the information/data on the
technical grade pesticide are available on the same species.
+++ Data requirement for category-I additionally will be required.
Regd.@ = The product containing the strain registered by Registration Committee.
* Applicable only in case of molecules which are not registered for domestic consumption in
India.
Table 5:
(b) Toxicology information/data requirements for grant of registration of Bacillus
sphaericus (B.s) & Bacillus thuringiensis (B.t) based pesticide exclusively for export
[Category VIII(b)]
Sl.
No.
Toxicity data / information #
Category – VIII(b)
Bt. & Bs. Based pesticide
Technical
Formulation
1.
2.
3.
4.
5.
6.
7.
Single Exposure Studies
Oral toxicity / Pathogenicity
Dermal toxicity / Pathogenicity
Mucous membrane irritation
Primary skin irritation
Inhalation toxicity / Pathogenicity
Allergy / Sensitization
Sign & Symptoms of poisoning/ First Aid,
treatment & other precautionary measures
R
R
R
R
R
R
R*
R
R
R
R
R
R
R*
Note : Allergy test has to be conducted as per Standard Protocol prescribed by Registration
Committee.
#
If a product is already registered strain then there is no necessity of above
information.
*
Applicable only in case of molecules which are not registered for domestic
consumption in India.
III. Packaging and Labelling Requirements for All Categories
All Categories (I to IX)
1.
2.
An undertaking with respect to type of packaging.
Labels and Leaflets as per Insecticides Rules, 1971.