1.10
Data requirements for registration of house hold pesticides
(Reference of 211th meeting of RC held on 30-05-2001 based on approval of 93rd meeting of 2808-1987 and additions based on approval in 266th meeting of 20-07-2006)
GENERAL REQUIREMENT:
1.
2.
All household pesticides as defined must be manufactured only from the technical
grade pesticides which are registered under the Insecticides Act, 1968.
Data on household pesticides formulation shall be considered along with the data
on technical grade pesticides and not in isolation.
CHEMISTRY:
The common name of the household insecticides which is to be printed on the labels
and leaflets should be written as household pesticides containing ‘x’….% w/w ‘y’….%
w/w and ‘z’…..% w/w etc.
1. Source of Supply of the Technical grade material with minimum purity to be
used in the formulation.
2. Chemical Composition
2.1 Complete Chemical composition of the formulation
2.2 Complete data on identity and Physico - Chemical Properties of various
ingredients of the formulations.
2.3 The Chemical composition for the formulation should include the kind,
Name & Percentage of all the ingredients that is to be used in the
formulation.
2.4 The number of active ingredients in household combination product should
not be more than two. However, if any applicant is able to submit
satisfactory method of analysis for more than two a.i. in the combination
product, the committee may consider such request on its merit.
3. Specification
3.1 Wherever no specifications are available, the registration secretariat may
harmonize specification evolving its own procedure.
4. Analytical Test Report
4.1 The ATR giving analysis of a particular batch of all the parameters included
in the specifications shall be submitted from an independent reputed
National / International laboratory.
5. Shelf-life Data
5.1 The expected shelf-life claim for the product along with the supporting
data, be submitted. This data should conform to the guidelines prescribed by
the central Insecticides Board.
6. Method of Analysis
6.1 Wherever applicable ISI methods of analysis is followed.
6.2 The method for the analysis of various a.i. used in a formulation be
provided. As far as possible, single multiple pesticides analysis methods be
suggested.
6.3 For identification of a.i. in the formulation, suitable quantitative methods
may be developed and provided followed by detailed analysis as per 6.2
above.
7. Process of Manufacture
7a. Information about Raw Materials Used & Their Source of Supply.
7b. Step-wise Manufacturing Process.
7c. Flow sheet diagram of process of manufacture
8. Effluent Treatment method
9. The applicant should provide sample along- with standards technical sample
from the principals/ authorized dealers for chemical verification.
10. Methodology for residue estimation as per BIS format.
(Above 7 -10 are added, based on approval of 266th meeting of RC held on 20-07-2006)
DATA REQUIREMENTS FROM BIOEFFICACY AND RESIDUE PARAMETERS:
A. Bio-efficacy claims in case of formulation
(1) Bio-efficacy claims to be given on the labels
(i) A brief direction concerning the major usages of the pesticides should be
given on the lables.
(ii) Whenever the Registration Committee has approved the product for
restricted use, this should be indicated very clearly on the labels in capital
letters. ‘For
use only.
(iii) Instruction regarding Insecticide ‘Not to be used on any food crop to be
given’.
(2) Bio-efficacy claims to be given on the leaflets
(i) Detailed information on the usages of insecticide indicating the name
of insects, method of application, dosage, places of treatment, PP
equipments to be used etc. should be given in paragraphs forms.
Common name of the insects should be given.
(ii) Whenever the registration committee has approved the product for
restricted use, this fact should be indicated very clearly on the leaflets
in bold letters.
(iii) Instructions regarding Insecticides ‘Not to be used on any food crop to
be given’.
B. Bio-efficacy claims to be given on the labels and leaflets in case of technical
grade material.
1. The purpose of import /manufacture of technical grade material is required
to be given on the labels and leaflets.
C. Data requirements on Bioefficacy and Residues for formulation of
pesticides for provisional registration of U/s 9(3B).
(I) The applicant should submit published / cited Indian data on bioeffectiveness in support of the claims indicated on the labels / leaflets.
The data should be produced from 2 National laboratories based on
minimum 2 repeated trials. This should be further supported with any
published information available from elsewhere (overseas data).
(II)
Information on secondary pests outbreaks particularly of ticks and mites
should be given where residual pyrethroids are being used.
(III) Data on Residues:
Data on persistence, of the pesticides which should be on different types of
surfaces should be submitted / generated obtained under foreign / Indian
conditions from 2 laboratories. This may also be supported by data
generated elsewhere.
(IV) Data on concentration of a.i. in Air - for Aerosols (e.g. Coil, mats, liquid
vaporizer etc.). (Added based on approval in 266th meeting of RC held on
20-07-2006)
(V) Registration Status in foreign countries. (Added based on approval in 266 th
RC meeting)
D. Data requirements on Bio-efficacy & Residues data requirement for
regular registration of formulations of pesticides U/s 9(3):
(i)
(ii)
(iii)
(iv)
(v)
Bio-efficacy test on the proposed formulations should be conducted under
Indian conditions minimum on two trials in each three national
laboratories.
Data on persistence of pesticides on different types of surfaces should be
generated in three national laboratories wherever applicable.
Information on secondary pests outbreaks particularly of ticks and mites
should be given where residual Pyrethroids are being used.
Data on concentration of a.i. in Air - for Aerosols (e.g. Coil, mats, liquid
vaporizer etc.). (Added based on approval in 266th meeting of RC held on 2007-2006)
Registration Status in foreign countries. (Added based on approval in 266 th
RC meeting)
E. Data requirements for the registration of new formulations of the
approved pesticides.
Data on bio-effectiveness and persistence on different surfaces as required in
case of Registration of formulations for regular registration under section 9(3).
F. Data required for combination products.
Bio-efficacy data on combination products v/s individual products. Data on
persistence on different types of surfaces should also be submitted. All above
data should be generated as per the requirement indicated in case of
pesticides required for regular registration under section 9(3).
G. Methodology:
Flying/crawling insects
Residual films of insecticides prepared by spraying insecticides on different types of
surfaces, such as Glass, Wood, Mud & Cement surfaces. Insects to be exposed for 30
minutes and than shifted to recovery chambers for 24 hours after which the mortality
count should be made and the satisfactory mortality of insects would be more than
90%. The residual toxicity of insecticides should also be studied at different intervals.
Evaluation of space spray against flying insects should be conducted in PEET GRADY
Chamber as per standard ISI specification 1824, mats/coils could also be evaluated
inside the Peet Grady Chambers against caged mosquitoes and the knock down effect is
to be recorded at different intervals. Aerosols are to be evaluated inside a standard
room. The test are to be conducted as per WHO technical reports series No. 206.
PACKAGING & LABELLING DATA REQUIREMENTS.
Guidelines on the data requirements for the packaging & Labelling for the grant of
registration of Household products of Pesticides formulations.
Type of formulation Physical state of formulation
Solid - coil, cake-mat, liquid,
paste, aerosol and others.
1. Proposed labels
As per Insecticides Rules, 1971 / Existing
norms of the Registration Committee.
2. Proposed leaflets
As per Insecticides Rules, 1971 / Existing
norms of the Registration Committee.
3. Manner of Packaging
(1) In general, the requirements for packaging of household pesticides are governed
according to IS: 8190 (part-III)-1979 and amendment thereof, if any.
(2) Glass bottles of glass used as primary packaging material is not permitted for
household pesticides
(3) Details of points (a) to (d) as under should be submitted. If the packaging
material dose not conform to IS specifications.
(a) specification for primary packages.
(b) Specification for secondary package
(c) Specification for transportation packaging.
(d) History of conventional usage of packaging.
4. Compatibility: if the compatibility of container with pesticides is already established
the relevant Indian Standards number for said packaging material may
be quoted.
In case compatibility is not established detailed
specifications for primary package is required to be furnished
indicating dimension, material construction design etc. along with test
reports with reference to physico-chemical requirements for field
trial/studies for transport worthiness. The analysis report should be
according to relevant Indian standards specifications on packaging and
quality control or as per specifications/test methodology, approved by
the Registration Committee.
5. Instructions for storage and use including first aid and precautionary measures
proposed for labelling.
6. Information regarding disposal of used package, surplus material and washing of
insecticides proposed for labelling.
TOXICITY - TOXICOLOGICAL DATA REQUIREMENTS
Category - I (Solid)
1.Acute oral toxicity in rats and mice or any other two species
2. Acute dermal toxicity in rabbit
3. Primary skin irritation
4. Irritation to mucous membrane
5. Toxicity to birds
6. Toxicity to fish
7. Toxicity to beneficial insects
Category - II (Liquid)
1. Acute oral toxicity in rats and mice
2. Acute dermal toxicity in rabbit
3. Acute inhalation toxicity
4. Primary skin irritation
5. Toxicity to birds
6. Toxicity to fish
7. Toxicity to beneficial insects
Category - III (Vapours)
1. Same as category II
2. Health monitoring study of the user by using the household pesticides in its actual
use. The symptoms and signs as a result of sub acute chronic or delayed effects on
man from single or multiple exposure to the product shall be observed and
submitted to the RC.
There would be two types of House-hold products from the view point of safety viz:
I : Ready- to – use formulations for house- hold purposes;
II. Concentrated forms of formulations to be used only by the pest control operators,
commercial establishments, Government agencies, for large scale disinfestations
etc. However, in case of specific requirements, the type I for use in concentrated
form could be considered by the committee on merit basis.
Note: The application may be submitted according to the Checklist for submission of
application in 5 folders for Registration of Pesticides U/s (3) / 9(3B).
-Reference icon ‘Checklists’ on the website.