1
INTRODUCTION
Sections 7-13 of the Pesticides Act 1974 provides for the control of importation and
manufacture of pesticides. The objective of pesticide registration is aimed at ensuring
that pesticides offered for sale in the country are of good quality, effective for their
intended use and at the same time would not cause unacceptable adverse effects to
man and the environment.
Registration of pesticides is implemented through the Pesticides (Registration) Rules
2005 which was gazette on 18 August 2005 to replace the Pesticides (Registration)
Rules 1976. These new Rules describe how pesticide registration approval can be
obtained from the Pesticides Board.
TERMS AND DEFINITIONS
Pesticide
The term ‘pesticide’ under the Pesticides Act 1974 is defined as ‘any substance that
contains an active ingredient’ or ‘any preparation, mixture or material that contains any
one or more of the active ingredients as one of its constituents’, while the term ‘active
ingredient’ means an ingredient, as listed in the First Schedule of the Pesticides Act
1974.
Generally pesticides includes, but are not limited to, herbicides, insecticides,
fungicides, acaricides, nematicides, rodenticides, molluscicides, bactericides,
fumigants, soil fumigants, miticides, preservatives, repellants and termiticides.
Applicants are required to refer to the First Schedule of the Pesticides Act 1974, in
order to ascertain whether their product contains any of the listed active ingredients,
thus requiring registration. As the First Schedule is updated from time to time to
include new active ingredients, it is necessary for the applicant to refer to the
Pesticides Board for the updated listing.
Proprietary and Commodity Pesticide
For the purpose of registration, pesticides are divided into 2 categories namely
proprietary and commodity.
Commodity pesticides are pesticides containing active ingredients that have been
registered in Malaysia for not less than 10 years.
Proprietary pesticides are pesticides that are not commodity pesticides as defined
above are classified as proprietary pesticides. In case the of a pesticide mixture
containing proprietary and commodity active ingredients, the pesticide shall be
considered as a proprietary pesticide.
2
Manufacture
The term manufacture as defined by the Act means to prepare, compound, formulate,
mix, make, pack, re-pack or label a pesticide or otherwise treat the pesticide with a
view to its sale.
Registration
Registration is a process of evaluation and approval by the Pesticides Board before a
pesticide is allowed to be imported, manufactured, sold and used in the country. Only
those pesticides that are of good quality, effective for the intended purposes and do
not cause unacceptable adverse effect on human beings, animals, plants, fruits or
property would be registered in the country.
In order for the evaluation to be carried out, the Pesticides Board requires the
applicant to submit relevant data when applying for the registration. The data
requirements for pesticide registration under these rules are adapted from the Food
and Agriculture Organisation of the United Nations (FAO) and other international
organizations. The details of information required for evaluation are given in the
application form.
A separate application is required if the pesticide is different from another pesticide. A
pesticide is considered different from another pesticide, if:
(a) the active ingredient of that pesticide is different from that of the other
pesticide;
(b) the trade name or trade mark of that pesticide is different from that of the
other pesticide;
(c) the ingredients of that pesticide are different from those of the other
pesticide in type, number, proportion, concentration, or in other respects; e.g.
glyphosate isopropylamine 13.6% w/w soluble concentrate (SL) and glyphosate
isopropylamine 41.0% w/w soluble concentrate (SL) must be registered
separately under each concentration;
(d) the pesticide is differently formulated from the other pesticide, e.g. if alpacypermethrin is formulated as an emulsifiable concentrate (EC) and also as
suspension concentrate (SC), it must be registered separately under each
formulation;
(e) the pesticide is manufactured by a manufacturer other than the
manufacturer of the other pesticide; e.g. if benomyl is manufactured by two
companies, the products from both companies must be registered separately
even if the products are identical; or
(f) that pesticide is different in quality, nature, characteristics or efficacy from
the other pesticide; e.g. if one azadirachtin product is different in quality, nature,
characteristics or efficacy from another product it must be registered separately
from the other.
3
A separate application is also required if the category of usage is different e.g.
insecticide for agriculture use and insecticide for public health.
APPLICATION PROCEDURES
Application For Registration
Application to register and re-register a pesticide must be made using Application
Form, Form A [Subrule 2(1)] (Application For Registration/Re-registration Of A
Pesticide)] and only locally registered companies may apply. All applications must be
submitted to the following address:
Secretary
Pesticides Board
Pesticides Control Division
Department of Agriculture
4th Floor Wisma Tani
Jalan Sultan Salahuddin
50632 Kuala Lumpur.
Tel No: 03-2030 1400
Fax No: 03-2691 7551
Application forms are obtainable from the above-mentioned address. Submissions
should be made well in advance of the desired registration date.
Applicants should indicate in the standard cover-letter of the application (see Annex I)
whether the product is a commodity pesticide or a proprietary pesticide. The onus is
on the applicant to provide evidence that a product is a commodity pesticide. Some
common active ingredients which are considered as commodity pesticides are listed in
the latest edition of “Syor-Syor Kawalan Diluluskan Untuk Racun Perosak Komoditi”
(GP5). This list serves as a guide only and is subject to review from time to time. For
commodity pesticides, some registration requirements have been waived but the
Pesticides Board reserves the right to still request for them if necessary.
Applicants are also advised not to proceed with the printing of the final labels until the
product has been granted registration.
The period of registration of a pesticide is 5 years, effective from the date of
registration unless it is terminated by the registrant or cancelled by the Pesticides
Board. Under the Pesticides (Registration) Rules 2005, two types of fee will be
imposed on an application to register and re-register a pesticide. The fee for an
application is RM1,500.00 (one thousand five hundred ringgit) payable at the time
the application is submitted. This fee is not refundable. Upon approval, a
registration/re-registration fee will be imposed for each product payable prior to the
issuance of the Registration Certificate. The amount1 imposed for registration varies
according to class as follows:-
Class 1a and
hundred ringgit)
1b
per
4
approval: RM3,500.00
(three
thousand
five
Class II per approval
: RM2,000.00 (two thousand ringgit)
Class III per approval
:RM1,000.00 (one thousand ringgit)
Class IV per approval
: RM 500.00 (five hundred ringgit only)
New Registration
The following are the requirements for an application for registration of a new
pesticide:
a) Five (5) sets of application forms and supporting information.
This must include a set of the original copy. If the information submitted consists of
many volumes, a complete dossier with the original set and four (4) sets of
summaries may be submitted. Please refer Part E of the Application Form for the
information to be submitted.
b) All information must be on A4 size paper, properly filed in A4 size folders and
accompanied by a standard cover-letter. (See Annex I).
c) The source(s) of a pesticide must be declared in the cover letter. In addition a letter
from the source(s) confirming that they are the suppliers of the pesticide should
also be submitted. A maximum of 3 sources will be allowed at any one time
provided the composition and percentage of all the ingredients are identical. An
outline of the manufacturing process from all the sources must be submitted. Any
change of source(s) or manufacturing process during the period of registration
must be approved by the Pesticides Board.
d) Letter authorizing the use of data from the owners of the data.
e) Each set of the application should be accompanied by a copy of the draft label.
Two additional draft labels are to be attached to the cover-letter.
f) A pesticide sample from each of the sources must be submitted, suitably packed
and clearly labeled with the following information i.e trade name, applicant name,
active ingredient, concentration, type of formulation and the source name. The
quantities required are as follows:
Technical material
Formulated material
Aerosol
Mosquito coil
Mosquito mat
Others
-50 g or 50 ml
-100 g or 100 ml
- 4 x 100 ml cans or more
- 4 x 10 pieces
- 2 x 30 pieces
- refer to Pesticides Board
5
The registration sample must not be submitted in plastic bags in order to avoid
spillage and contamination. Dust/powder or liquid formulations should be placed in
either plastic or glass bottles. For dust or powder formulations, wide-mouthed
bottles fitted with stoppers or seals should be used. Samples should be not sent
by post but should be sent either by hand or by courier service. All imported
samples must be accompanied with an Import Permit endorsed by the Malaysian
Customs.
g) Analytical standard must be submitted for each active ingredient listed in the
application. Analytical standard samples must be accompanied by an Import
Permit (endorsed by the Royal Malaysia Customs Department), Certificate of
Analysis, and information on the date of expiry of the standard must be provided
(date of expiry must not be less than 1 year from date of submission). Some active
ingredients are exempted from submission of analytical standard1. The
specifications mentioned above for submission of samples also applies to
submission of analytical standards.
h) Each application must be submitted with a copy of the current Certificate of
Registration of the company (ROC/ROB).
i) Banker’s draft/money order/postal order of RM 1,500.00 (one thousand five
hundred ringgit) per application, made payable to the Director General of Agriculture,
as the payment for the application.
__________________________________________________________________________________
*
1
**
2
as per circular B.81/05.20/Jld. V( 25 ) dated 12 Dis. 2008
5 sets as per circular B.81/05.20/Jld. IV(65 ) dated 6 Dis. 2000
6
Re-registration
The validity period of a registration is 5 years. Before the end of the validity period, the
registrant may make an application to re-register the pesticide, and the application
must be submitted not earlier than 1 year BUT not later than 6 months before expiry.
Late submissions to re-register may not be accepted and may necessitate the
pesticide be submitted as a new application.
The following are the requirements for an application for re- registration:
a) One (1)* set of application forms.
b) Four (4) copies of amended draft label.
c) A copy of the current Registration Certificate.
d) The source(s) of a pesticide as approved by the Pesticide Board must be
declared in the cover-letter. In addition, a recent letter of undertaking (not more
than one year from the date of application for re-registration) from the source(s)
confirming that they will continue to be the suppliers of the pesticide should also
be submitted. A maximum of 3 sources will be allowed at any one time provided
the composition and percentage of all the ingredients are identical. An outline
of the manufacturing process from all the sources must be submitted (Please
Refer Annex II, Chapter 1, Item 1.3 and 1.9). Any change of source(s) or
manufacturing process during the period of registration must be approved by
the Pesticides Board, and such evidence must be submitted at re-registration.
e) Data on five batch analysis.
f) A copy of the current Certificate of Registration of the company (ROC/ROB).
g) All information must be on A4 size paper and accompanied by a standard
cover-letter. (See Annex I).
h) Banker’s draft/money order/postal order of RM1,500.00 (three thousand
ringgit) per application made payable to the Director General of Agriculture as
payment for the application.
7
How To Complete The Application Form
The Application Form is divided into 7 parts i.e. A, B, C, D, E, F and G and all parts
must be completed.
For Part E, however, depending on the general use pattern of the pesticide (whether
proprietary or commodity) some studies or information/data may be waived. To assist
the applicant in providing the right data/information to support the application to
register or re-register a pesticide, Annex II provides a summary of data requirements
for different types of pesticides.
In addition to the above, the applicant should also refer to the following guidelines for
detailed information on how such data/studies should be generated and compiled:
i)
ii)
iii)
iv)
v)
Guidelines on Product Chemistry Data Requirements For Pesticide Registration
(GP 1)
Guidelines on Toxicological Data Requirements For Pesticide Registration (GP
2)
Guidelines on Efficacy Data Requirements For Pesticide Registration (GP 3)
Guidelines on Residue Data Requirements For Pesticide Registration (GP 4)
Syor-Syor Kawalan Diluluskan Untuk Racun Perosak Komoditi (GP 5)
LABELLING REQUIREMENTS
The label represents an important source of information to the user of a pesticide. A
label is the written, printed or graphic material firmly attached to a product container.
Among others, the label should contain the identity of the pesticide and instructions on
use, precautions to be taken and other relevant information. This is to ensure that the
pesticide is used properly and effectively. Under the Pesticides Act 1974, a pesticide
shall not be sold unless it is registered and labelled with an approved label. To ensure
proper labelling of pesticides sold in the country, the Pesticides (Labelling)
Regulations 1984 have been gazetted and should be used. As part of the process of
approving an application for registration, the proposed label of a pesticide is evaluated
to ensure that it complies with the requirements of these regulations. To comply with
the labelling requirement, therefore refer to the Pesticides (Labelling) Regulations
1984. For guidance, the applicant is advised to refer to Annex III which provides two
layout examples that meet the requirement of the Pesticides Board.
The applicant should also refer to the latest edition of ‘Garis Panduan Untuk Nama
Dagangan Racun Perosak’ in order to ensure trade name given to the pesticide is
acceptable to the Pesticides Board.
8
MANUFACTURING
FOR
EXPORT PURPOSES
Registration approval under the Pesticides (Registration) Rules 2005 is only meant for
all activities to import and manufacture pesticides intended for local market and sale.
However, if the pesticide is solely manufactured for export, registration approval is not
required, provided it contains an active ingredient which is at the time registered with
the Pesticides Board. It is the duty of the manufacturers to check with the Pesticides
Board, to confirm if such an active ingredient is already registered in Malaysia.
IMPORTATION OF AN UNREGISTERED PESTICIDE
An unregistered pesticide may only be imported in a limited quantity for educational or
research purposes, or as a registration sample or in the form of analytical standard by
means of a import permit as provided for under the Pesticides (Importation for
Educational and Research Purposes) Rules 1981. Copies of the "Guidelines on
Application for Permit to Import Pesticides for Educational and Research Purposes" are
available from the Secretary of the Pesticides Board upon request.
PENALTIES
It is illegal under the Pesticide Act 1974, to import and/or manufacture pesticides
without any valid registration approval from the Pesticides Board. Any person, if found
guilty of importing or manufacturing any pesticide without valid registration approval, is
liable on a first conviction, to imprisonment for 5 years or to a fine of RM50,000 and,
on a second or subsequent conviction, to imprisonment for 10 years or to a fine of
RM100,000 or both.
9
Annex I
THIS STANDARD COVER LETTER IS TO BE
TYPED ON APPLICANT'S COMPANY LETTERHEAD
Date :
Secretary
Pesticides Board
Department of Agriculture
4th Floor, Wisma Tani
Jalan Sultan Salahuddin
506320 Kuala Lumpur.
Dear Sir,
APPLICATION TO REGISTER/RE-REGISTER PESTICIDE
Herewith is an application to register/re-register *
__________________________________________________________________
(state trade name)
(please tick whichever is applicable)
[___] Commodity Pesticide
[___] Proprietary Pesticide
[___] New Registration
[___] Re-registration
LRMP/R1 No. : ........................
File No. : JP KRP 207/12/171/.............
[___] 5 set of application (Form A)
[___] 1 set of application (Form A)
5 sets with 1 original set of data
[___] Data on five batch analysis
requirements (Part E- Form A)
1 copy of proposed label in
[___]
[___] 1 Photostat copy of endorsed printed label
each set
2 copies of proposed labels
[___]
[___]
copies of amended draft labels
attach with cover letter.
[___]
Copy of current Registration Certificate
[___]
10
APPLICABLE TO REGISTRATION & RE-REGISTRATION
[___]Sample suitably packed and labeled. (With copy of Import Permit, if necessary)
[___]Sample of analytical standard suitably packed and labeled. (With copy of Import
Permit, if necessary)
[___]Letter of certification from source of the pesticide.
[___]Letter of authorization on the use of data.
[___]Copy of company registration (ROC/ROB)
The source(s) (Name and address) of the above pesticide are:
1. _________________________________________________________________
____________________________________________________________________
2. _________________________________________________________________
____________________________________________________________________
3. _________________________________________________________________
____________________________________________________________________
Thank you.
Yours faithfully,
___________________
(Name and Signature of
applicant & Company stamp)
11
Annex II
SUMMARY OF DATA REQUIREMENTS FOR PROPRIETARY AND COMMODITY
PESTICIDES ACCORDING TO GENERAL USE PATTERN
(REFER APPLICATION FORM,
PART E: PARTICULARS ON DATA REQUIREMENTS)
Chapter
Food
Commodity
General Use Pattern
NonIndoor
Out
Forestry Technical Technical
Food
/ House Door/
Material
ConcenCom- hold
Public
(TC)
trate
modity
Health
(TK)
Notes
CHAPTER 1:
IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES (Refer to GP1/2015)
Part A : Requirement On Data for technical grade of active ingredient (TGAI) is required on cases where TGAI is not
registered with Pesticides Board but its formulated product (ready-made) is directly imported and
Technical Active
is intended to be registered.
Ingredient
1.1
1.2
1.3
1.4
Manufacturer
name and contact
information
ISO common
name and
synonym
Chemical name
Existing CAS and
CIPAC number
1.5
Identity and
composition
1.6
Specification of
purity of active
ingredient
1.7 Molecular
formula,
molecular mass
and molecular
structure
1.8
Method of
manufacturing
process (starting
material, pathway,
byproducts and
impurities) and
quality control.
1.9 Identity, content,
structural formula
of isomer,
impurities and
additive.
1.10 Data on five batch
analysis including
the profile of
impurities and
chromatogram.
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Endorsed by QA
manager
Must comply with the
standards of Good
Laboratory Practices
(GLP).
12
Chapter
1.11 Physical and
chemical
properties:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
General Use Pattern
Food
NonIndoor
Out
Forestry Technical Technical
Notes
ComFood
/ House Door/
Material
Concenmodity Com- hold
Public
(TC)
trate
modity
Health
(TK)
Must comply with the
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standards of Good
Laboratory Practices
(GLP).
For solids; its melting
point (at stated
temperature).
For liquids, vapour
pressure, boiling point,
(at stated temperature),
specific gravity and
viscosity (at stated
temperature)
Flash point
Solubility in water and
other solvents- at least
2 solvent (at stated
temperature)
n-octanol/water
partition coefficient
Hydrolysis rate,
photolysis (under
stated conditions)
Stability towards
oxidizing agents and
thermal changes
(corrosiveness testing)
Dissociation constant
(pKa, pKb)
Part B : Requirement On
The Formulation (if
relevant)
1.12 Manufacturer name
and contact
information
1.13 Detail qualitative
and quantitative
information of the
composition of
preparation
1.14 Method of
manufacturing
process (material
used and condition
required)
1.15 Type of formulation
and function
Commodity : i, ii & iii.
Proprietary : All (i – viii)
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Manufacturing Limits
(min-max).
Endorsed by QA
manager
Endorsed by QA
manager
13
Chapter
1.16 Physical and
chemical
properties:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
Appearance
 Physical state (for all
formulation)
Corrosiveness
Flammability (if
applicable)
Known compatibility
with other chemicals
(only to be performed
when tank mix is
recommended on the
label)
Oxidation/reduction :
chemical
incompatibility (only
to be performed when
tank mix is
recommended on the
label)
Rate of release, or
release/retention index,
of active ingredient
(for slow- release
granules (CG), slowrelease capsule
suspensions (CS), long
lasting insecticidal nets
(LN).
“Free” active
ingredient (For slow
release granules (e.g:
encapsulated granules,
CG) and slow release
capsule suspensions
(CS).
By-products of
manufacture or storage
(all specifications
where relevant
impurities may be
associated with active
ingredient
Acidity or alkalinity
and if necessary pH
Explosivity.
General Use Pattern
Food
NonIndoor
Out
Forestry Technical Technical
Notes
ComFood
/ House Door/
Material
Concenmodity Com- hold
Public
(TC)
trate
modity
Health
(TK)
Must comply with the
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standards of Good
Laboratory Practices
(GLP).
14
Chapter
1.17 Specific Properties/
Test Related to Use:
 Wettability
 Persistent
foaming
 Suspensibility
 Wet sieve test
 Dry sieve test
 Emulsion stability
 Dilution stability
 Flowability
 Pourrability
 Dustability
 Distribution and adherence to seed
 Others
1.18 Storage stability test
(FAO Accelerated
Storage Test
Procedures may be
employed)
1.19 Specifications of the
product (indicate
whether it meets
any specifications
e.g. Malaysian
Standard,
FAO/WHO
specification or
others)
1.20 Safety Data Sheet
(SDS)
1.21 Packaging
(including packaging
material and its
compliance to any
standards or
specifications)
1.22 Data on five batch
analysis of the active
ingredient including
chromatogram (if
applicable)
General Use Pattern
Food
NonIndoor
Out
Forestry Technical Technical
ComFood
/ House Door/
Material
Concenmodity Com- hold
Public
(TC)
trate
modity
Health
(TK)
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Notes
Comply with the standards
of Good Laboratory
Practices (GLP) / ISO
Conditionally required.
Required if the product
had been registered
elsewhere.
15
Chapter
General Use Pattern
Food
NonIndoor
Out
Forestry Technical Technical
ComFood
/ House Door/
Material
Concenmodity Com- hold
Public
(TC)
trate
modity
Health
(TK)
CHAPTER 2 :
METHOD OF ANALYSIS (Refer to GP1/2015)
2.1 Validated methods of
analysis of active
ingredient in the
technical material
2.2 Validated method of
analysis of active
ingredient content in
the formulation
2.3 Validated methods of
analysis of content of
impurities in the
technical material and
formulation.
2.4 Validated methods of
analysis for residue of
the active ingredient
and all important
metabolites in all
relevant matrix of the
crops.
2.5 Validated methods of
analysis for residue of
the active ingredient
and all important
metabolites in
environmental media.
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Notes
16
Chapter
Food
Commodity
NonFood
Commodity
General Use Pattern
Indoor
Out
Technical
/ House
Door/
Forestry material
hold
Public
health
Notes
CHAPTER 3 :
IMPACT ON HUMAN AND ANIMAL (MAMMALIAN TOXICOLOGICAL DATA) (Refer to GP2/93)
To submit requirements of Part A or Part B or both.
To submit either Part A or Part B. Submission of both Parts A & B (i.e Data on Technical and Formulation) is also acceptable.
However, if any of the a.i(s) in the formulation is proprietary, submission of Part B (if selected) must include data requirements
Part A (3.2) to A (3.5). These data may be based on either the technical a.i(s) or formulated product.
- Laboratory performing toxicology studies must comply with the standards of Good Laboratory Practices (GLP).
- GLP Certificate issued by the Compliance Monitoring Authority (CMA) national authorities or bodies accredited to monitor
compliance with the Principles of GLP toxicity studies must be attached.
- For the registration application can't meet GLP requirements, the Pesticide Board may give special consideration to the
application if requested products have specific needs and interests of the nation.
*Please refer secular dated 25 Feb 2013.
PREMIXTURE ACTIVE INGREDIENT
- food crop usage (insecticide/fungicide): mandatory toxicology data on MIXTURE
- Herbicide: toxicology data on single active ingredient is acceptable.
SINGLE ACTIVE INGREDIENT
- toxicology data on technical grade or finish product is acceptable
Part A: Requirement On
Technical Active
Ingredient
3.1 Acute toxicological
data
3.1.1 Acute oral
studies (in rats)
3.1.2 Acute dermal
studies (in rats)
3.1.3 Acute inhalation
studies (in rats)
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3.1.4 Skin irritation
studies (in
rabbits).
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3.1.5 Eyes irritation
studies (in
rabbits).
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3.1.6 Dermal
sensitisation
study (in guinea
pigs).
3.1.7 Acute delayed
neurotoxicity in
hens (for
organophophates
and carbamates)
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route
Not required for commodity
pesticide
17
Chapter
Food
Commodity
NonFood
Commodity
General Use Pattern
Out
Indoor Door/
Technical
/ House Public
Forestry material
hold
health
3.2 Sub-acute toxicological
data
Notes
Not required for commodity
pesticide, unless acute toxicity
profile indicates that there is a
strong possibility that subacute exposure can result in
significant negative effects.
3.2.1 Repeated dose 21 or √
28 days dermal
toxicity (in rats)
3.2.2 Repeated dose 28
√
days oral delayed
neurotoxicity in hens
(organophosphates
and carbamates if
triggered by findings
of acute delayed
neurotoxicity).
3.2.3 Sub-acute 90 days
√
dietary feeding study
(in rats)
3.3 Chronic toxicological
data
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
3.3.1 Chronic dietary
feeding study (24
monts in rats,
18monts in mouse
and 1 year in
dogs).
3.3.2 Oncogenicity
study (not less
than 24 months
for rats and
18months for
mouse. This study
can be combined
with chronic
feeding study, if
appropriate).
3.4 Supplemental
toxicological studies
√
√
√
√
√
√
√
√
√
√
√
√
3.5 Teratogenicity study (2
species, one redent and
one non-rodent)
√
Not required for commodity
pesticide, unless acute and
sub-chronic toxicity profile
indicates that there is a strong
possibility that chronic
exposure can result in
significants negative effects.
Not required for commodity,
unless its toxicity profile/ use
recommendations indicates
that there is a strong
possibility that exposure can
result in long-terms significant
negative effects in relation to
the aspects as stated below.
√
√
√
√
√
18
General Use Pattern
Food
Commodity
NonFood
Commodity
Indoor
/ House
hold
3.6 Reproductive study (2
generations of rodents
and one litter).
3.7 Mutagenicity study (at
least in 3 battery of
tests to detect gene
mutation, chromosomal
aberration and
genotoxic effects)
3.8 Metabolic study (at
least one species)
3.9 Human toxicology data
(such as industrial
exposure data,
accidental data or
volunteer data).
3.10 Toxicological
information of every
ingredient, synergist,
and major or important
impurity of the
pesticides.
Part B : Requirement On
The Formulation (if
applicable)
3.7 Acute oral toxicity
study in rats.
√
√
√
√
√
√
Not required for commodity
√
√
√
√
√
√
Not required for commodity
√
√
√
√
√
√
Not required for commodity
√*
√
√
√
√
√
Not required for commodity
Optional unless requested
√
√
√
√
√
√
Not required for commodity
pesticide
√
√
√
√
√
-
3.8 Acute dermal toxicity
study in rates.
√
√
√
√
√
-
3.9 Skin irritation study in
rabbits
√
√
√
√
√
-
3.10 Eye irritation study in
rabbits
√
√
√
√
√
-
3.11 Skin sensitisation study
in guinea pigs.
√
√
√
√
√
-
Preferred studies, in additions
to studies on technical
material (Refer 3.1.1.)
Preferred studies, in additions
to studies on technical
material (Refer 3.1.2.)
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route.
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route.
Not required for commodity
pesticide, unless studies
indicate significant exposure
through this route.
3.12 Acute inhalation study
in rats (if applicable)
√
√
√
√
√
-
Chapter
Out
Door
Technical
Forestry material
Notes
Not required for commodity,
unless studies indicate
significant exposure through
this route.
19
General Use Pattern
Chapter
Food
Commodity
NonFood
Commodity
Indoor
/ House
hold
Out
Door
No required if it is
recommended on 16th Schedule
(Regulation 41)
CHAPTER 4 :
RESIDUE (Refer to GP4/2012) & (16th Schedule (Regulation 41)
4.1 Definitions of the
residue to Maximm
Residue Limits
(MRLs)
4.2 Detailed reports on
supervised residue trial
on recommended crops
based on accepted
protocols (e.g. FAO
Manual on the
Submission and
Evaluation of Pesticide
Residue Data for the
Estimation of
Maximum Residue
Limits in Food and
Feed, FAO, UN 2002).
Studies conducted
under similar climatic
conditions may be
submitted.
4.3 Residue analytical
method with
chromatograms for
standard, control,
sample and recovery
test.
4.4 Information on
metabolism or
degradation of the
active ingredient in
crops or plants
4.5 Acceptable Daily
Intake (ADI) of the
pesticide in mg/kg
body weight.
4.6 Proposed Pre-harvest
interval (PHI) or PreSlaughter Interval
(PSI)
4.7 Proposed Maximum
Residue Limits
(MRLs) calculated
based on Dietary Risk
Assessment of the
pesticide.
4.8 Maximum Residue
Limits (MRLs) from
other countries that
have registered the
pesticide
Notes
Technical
Forestry material
√
-
-
-
-
-
√
-
-
-
-
-
At least three field
experiments done at different
sites must be
submitted.
For a major crop, which is oil
palm, cocoa, paddy and black
pepper, at least one field
experiment must be
generated under local
conditions.
√
-
-
-
-
-
Analytical method by crop
√
-
-
-
-
-
Mandatory for proprietari a.i.
√
-
-
-
-
-
ADI by a.i
√
-
-
-
-
-
PHI by crop
√
-
-
-
-
-
Proposed MRL by crop
√
-
-
-
-
-
MRL by crop
20
Chapter
Food
Commodity
NonFood
Commodity
General Use Pattern
Indoor
/ House
Out
Technical
hold
Door Forestry material
CHAPTER 5 :
FATE AND BEHAVIOUR IN THE ENVIRONMENT (Refer to GP2/93)
5.1 Definition of the residue √
√
√
√
relevant to the
environment
5.2 Degradation and
√
√
√
√
dissipation studies
(hydrolysis, photolysis
in water and soil)
5.3 Metabolism studies (in √
√
√
√
water and soil for both
aerobic and anaerobic
conditions).
5.4 Mobility studies
√
√
√
√
(leaching and
adsorption or
desorption studies,
volatility in laboratory
and field).
5.5 Fate and behavior in
√
√
√
√
air.
5.6 Bioaccumulation study √
√
√
√
in fish
CHAPTER 6 :
EFFECTS ON NON TARGET SPECIES (Refer to GP2/93)
6.1 Effects on terrestrial
√
√
√
√
vertebrates (including
acute oral toxicity to
avian species e.g.
pigeon, quail, pheasant,
or duck).
6.2 Effects on aquatic
species
6.2.1. Acute LC50, 96
√
√
√
√
hours exposure
on the suitable
fish species.
6.2.2. Acute LC50, 48
√
√
√
hours exposure
on one suitable
fish-food species
e.g. daphnia
6.3 Effects on bees and
√
√
√
other arthropod species
(including acute oral
LD50, and contact
toxicity on honey bees)
6.4 Effects on earthworms
√
√
√
and other soil macroorganisms (including
acute toxicity on
earthworms).
6.5 Effects on other non√
√
√
target organisms (flora
and fauna)
Notes
-
-
-
-
-
-
-
√
-
√
-
√
-
√
-
21
General Use Pattern
Chapter
Food
Commodity
NonFood
Commodity
Indoor
/ House
hold
Out
Door
Technical
Forestry material
Notes
CHAPTER 7 :
EFFICACY DATA AND INFORMATION (Refer to GP3/93)
- All reports submitted must be very recent and shall not be more than 15 years from the date of submission.
- Not required for HERBICIDE if the active ingredient and its formulation is listed in GP5. *Please refer latest secular dated 26
Feb 2013.
- Journal data on bio-efficacy trial is acceptable.
7.1 Local Bio-efficacy
trials on the
recommended crops
based on the accepted
protocols (e.g. FAO
Harmonized Bioefficacy Protocols).
Trials conducted under
similar climatic regime
and cultural practices
may be used for minor
crops)
7.2 Phytotoxicity
assessment on crops
based on accepted
protocols (e.g. FAO
Guidelines for
Phytotoxicity
Assessment)
7.3 Effects on natural
Enemies
7.4 Information on
potential occurrence to
resistance
7.5 Comparative study
using Malaysian
Standard or other
internationality
accepted protocols for
all non-agriculture
pesticides
7.6 Information on mode of
action and its grouping.
7.7 Propose use(s) and
Recommendation in
tabulated form
- tabulated format
- statement format
* Not required for veterinary
products.
√*
√
-
-
√
√*
√
-
-
√
-
√*
√
-
-
√
-
√
√
-
-
√
- - Must submit bio-efficacy
trial data for each crop.
- For a major crop, which is
oil palm, cocoa, paddy and
black pepper, one field
experiment (with multiple
replicates) must submit bioefficacy trial generated
under local conditions.
- For Non major crop, bioefficacy trial from overseas
is acceptable.
* Not required for veterinary
products.
√*
-
√
√
-
-
√
√
√*
-
√
-
√
√
√*
√
√
-
[ KEY : (√ ) = Required; ( √* ) = Conditionally required and (-) = Not required ]
* Not required for veterinary
products.
-
* Not required for agricultural
products.
* Not required for household
pesticides.
*depending on the type of
usage
Refer to “Garis Panduan
(Pelabelan)”
22
EXAMPLES OF GENERAL USE PATTERNS
Food commodity


Agricultural crops for human
consumption
Veterinary
Indoor / Household



Non-food commodity






Crop for smoking
Ornamental plants
Lawn and turf grasses
General soil treatments
Recreational areas
Roads, tracks and paved areas
Household Pesticides
Rodenticides for household
use
Pet animals pesticides
Outdoor




Wood treatments
Antifouling treatments
Public health
Preservative
Forestry



Forest trees including dead trees,
logs and stumps
Forest tree nurseries
Non-ornamental trees including
rubber trees
Technical material

Technical material for
manufacturing purposes
23
Calculation Guidance:
For every constituent in the formulation, provide the following information in the table provided:
(a)
Perawis aktif
(nama biasa)
Nombor
Khidmat
Abstrak
Kimia
(CAS), jika
ada
Tujuan di dalam
perumusan
Peratusan sumber
keluaran di dalam
perumusan
(% b/b atau g/l)
Peratusan berat
perawis aktif di
dalam
perumusan
(% b/b)
Nama ai
(purity = x%)
A = declare x 100
purity
Declare on label
Contoh :
(Purity 81%)
Contoh :
0.30 x 100 = 0.370
81
Contoh :
0.30
A= 0.370
(b)
Perawis lengai
(nama biasa)
Nombor
Khidmat
Abstrak
Kimia
(CAS), jika
ada
Tujuan di dalam
perumusan
Peratusan sumber
keluaran di dalam
perumusan
(% b/b atau g/l), jika
terpakai
Peratusan berat
perawis lengai
dalam
perumusan
(% b/b)
(B)
JUMLAH (% b/b)
(A+B)= 100
24
25
26
27
PERAWIS AKTIF YANGTIDAK MEMERLUKAN PIAWAI ANALISIS
(ANALYTICAL STANDARD/REFERENCE MATERIAL)
1. ETHYLENEBISDITHIOCARBAMATE FUNGICIDE CONTOHNYA:
- Mancozeb
- Maneb
- Propineb
- Zineb
- Ziram
- Ferbam
- dan lain-lain kecuali thiram
2. COPPER BASE COMPOUNDS CONTOHNYA:
- Copper oxychloride
- Copper hydroxide
- Copper sulfate
- Copper sulfate (tribasic)
- Copper oxide
- Copper octanoate
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Oxine-copper
Potassium bicarbonates
Borax
Boric acid
Bordeux mixture
Calcium polysulfide
Sulfur
Sulfuric acid
Sulfuryl fluoride
Zinc phosphide, magnesium phosphide, aluminium phosphide dan lain-lain.
Sodium chlorate- titration
Umumnya piawai analisis tidak perlu dikemukakan jika kaedah analisis penentuan kandungan
perawis aktif tidak memerlukan piawai analisis.
28
B.81/05.20/Jld IV (102)
PENYERAGAMAN KEPEKATAN BAHAN AKTIF RACUN PEROSAK
Untuk Kegunaan Di Sektor Pertanian Dan PCO
Bil. Racun Aktif
Perumusan
Kepekatan yang dibenarkan
A. RACUN SERANGGA
i.
Chlorpyrifos
Pekatan Teremulsi (EC)
38.7% w/w;
21.2% w/w
ii.
Chlorpyrifos +
Cypermethrin a/
Pekatan Teremulsi (EC)
45.9% w/w + 4.6% w/w;
20.0% w/w + 2.0%w/w
iii.
Cypermethrin
(tidak termasuk 80/20)
Pekatan Teremulsi (EC)
*5.5% w/w;
10.5% w/w;
*16.0% w/w
B) RACUN KULAT
iv.
Carbendazim
Pekatan (SC)
42.0% w/w
v.
Chlorothalonil
Pekatan (SC)
40.0% w/w;
23.0%w/w
*Kepekatan bahan aktif yang dipinda
Catatan :
PCO - produk-produk yang digunakan oleh pengendali kawalan racun Makhluk
perosak
termasuk bagi tujuan Kesihatan awam. Bahan aktif yang
digunakan sebagai pengawet tidak terlibat.
-
a/
- walaupun kepekatan untuk rscun perosak ‘premixed’ diseragamkan , pihak
yang ingin mendaftarkannya perlu terlebih dahulu memenuhi segala keperluan
garispanduan untuk mendaftar racun perosak jenis ‘premixed’.
29
B.81/05.20/Jld IV(101)
PENYERAGAMAN BAHAN-BAHAN AKTIF
BI
L.
BAHAN AKTIF
KEPEKATAN
(%W/W)
1.
2,4-D dimethylamine
69.5 , 60 , 48
2.
2,4-D sodium salt monohydrate
85 , 95
3.
BPMC
50
4.
carbofuran
3
Butir 9GR)
5.
diazinon
5
Butir (GR)
55
Pekatan Teremulsi (EC)
38
Pekatan Teremulsi (EC)
42
Pekatan Ampaian (SC)
80
Serbuk Bancuh (WP)
52 , 39 , 27 , 13
51 , 41 , 27 , 13.6
39.4 , 33.6 , 22 , 12.1
52.2 , 39.8 , 13
Pekatan Larut Air (SL)
Pekatan Larut Air (SL)
Pekatan Larut Air (SL)
Pekatan Larut Air (SL)
57 , 84
Pekatan Teremulsi (EC)
96
Cecair (ULV)
5
48.4
50
Butir (GR)
6.
dimethoate
PERUMUSAN
Pekatan Larut Air (SL)
Serbuk Bancuh (SP)
Pekatan Teremulsi (EC)
7.
diuron
10.
glyphosate dimenthylamine
glyphosate isopropylamine
glyphosate monoammonium
glyphosate trimesium
11.
malathion
12.
metaldehyde
13.
methamidophos
14.
monocrotophos
55
Pekat (WSC)
phenthoate
50
Pekatan Teremulsi (EC)
trichlorfon
95
Serbuk Bancuh (WP)
paraquat dichloride
13 (formulated)
42 (technical)
Pekatan Larut Air (SL)
warfarin
0.05
Umpan Berbungkah (BB)
15.
Pekatan (WSC)
30
AKTA RACUN MAKHLUK PEROSAK, 1974
Garis Panduan (Pelabelan) pindaan 2003
KEHENDAK-KEHENDAK PELABELAN
Maklumat
Tiap-tiap racun makhluk perosak hendaklah mempunyai label yang mengandungi maklumat
yang berikut:Maklumat pada Panel Utama
Maklumat minimum yang perlu dicetak pada panel utama label:
1. Nama Dagangan
Nama Dagangan atau nama kepunyaan racun makhluk perosak dan nama
itu hendaklah sama seperti yang ditetapkan dalam perakuan pendaftaran racun makhluk
perosak. Perbezaan ketinggian huruf mestilah tidak melebihi 30 % dan perlu dicetak dalam
jenis serta bentuk font di samping warna, format dan kepekatan yang sama.
2. Perumusan
Perumusan racun makhluk perosak hendaklah sebagaimana
ditetapkan dalam
perakuan pendaftaran racun makhluk perosak. Ia hendaklah dicetak dalam huruf besar tanpa
ditebalkan.
Contoh: PEKATAN TEREMULSI (EC), CECAIR (TEKNIKAL),
3. Kegunaan
Pernyataan kegunaan sesuatu racun seperti racun rumpai, racun serangga, racun kulat
dan sebagainya termasuklah produk teknikal hendaklah dicetak dalam huruf besar tanpa
ditebalkan.
Contoh: RACUN SERANGGA, RACUN RUMPAI.
Bagi produk teknikal, pernyataan ‘RACUN MAKHLUK PEROSAK’ hendaklah
dicetak pada label. Cetakan juga hendaklah dalam huruf besar tanpa ditebalkan. Untuk
produk teknikal juga, kegunaan diganti dengan frasa seperti di bawah. Cetakan hendaklah
dalam huruf besar dan ditebalkan.
GRED TEKNIKAL UNTUK TUJUAN PERKILANGAN SAHAJA
Bagi produk untuk “Pest Control Operator” (PCO) yang tertentu, pernyataan ‘UNTUK
DIKENDALIKAN OLEH ORANG YANG TERLATIH SAHAJA’ hendaklah dicetak pada
label dalam huruf besar dan ditebalkan.
31
Bagi produk untuk kegunaan industri seperti cat beracun untuk kayu-kayan, pernyataan
UNTUK KEGUNAAN INDUSTRI SAHAJA hendaklah dicetak dalam huruf besar dan
ditebalkan.
4. Pernyataan Bahan-Bahan
Nama biasa bagi bahan aktif hendaklah diikuti dengan bahan lengai (jenisnya tidak
perlu dinyatakan) dengan peratusannya mengikut berat dan kandungan bahan hendaklah
dinyatakan sebagai % w/w (% berat/berat). Bagi racun makhluk perosak jenis lain, kandungan
perawis atau bahan hendaklah sepertimana yang tetapkan oleh Lembaga.
Abjad pertama bagi nama biasa tidak boleh menggunakan huruf besar jika abjad seterusnya
adalah dalam huruf kecil.
contohnya: Glyphosate isopropylamine - tidak diterima
glyphosate isopropylamine - boleh diterima
Cetakan hendaklah dalam huruf tebal sepertimana contoh di bawah:
Perawis Aktif : aaaaaa bbbbbb.................................. 00.0 % w/w
(aaaa................0.00 % w/w)
Perawis Lengai : ........................................................ 00.0 % w/w
5. Nama dan Alamat Syarikat
Hanya nama dan alamat syarikat yang mendaftar racun perosak perlu dinyatakan.
Penyata ‘Didaftarkan oleh:’ perlu dicetak dan masukkan No. Syarikat dan No. Telefon.
Penggunaan alamat peti surat tidak dibenarkan. Pastikan saiz cetakan tidak kurang dari 9 poin.
Alamat website adalah tidak dibenarkan dicetak pada label.
6. Nombor Pendaftaran
Nombor pendaftaran racun makhluk perosak sebagaimana yang ditetapkan oleh
Lembaga. Ia hendaklah dicetak dalam huruf tebal seperti berikut:
No. Pendaftaran: LRMP. R1/XXXX.
7. Kandungan Bersih
Kandungan bersih racun makhluk perosak, tidak termasuk
pembungkus
atau pembalut hendaklah dinyatakan mengikut isi padu atau berat sebagaimana disyaratkan
oleh Lembaga. Kandungannya hendaklah dinyatakan sebagai kuantiti minimum.Bilangan dan
berat bersih isi kandungan bagi setiap bungkusan kecil dalaman seperti pipette, sachet dan lainlain hendaklah dicetak pada label. Cetakan tanpa ditebalkan.
Contoh: Kandungan Bersih: 20 liter
32
8. Tarikh Mengilang
Tarikh mengilang sebenar racun makhluk perosak hendaklah dicetak pada label.
Cetakan boleh dibuat pada mana-mana bahagian label tanpa ditebalkan.Tarikh luput bagi
produk yang tempoh luput kurang daripada 2 tahun juga hendaklah dicetak pada label.
Penggunaan label pelekat adalah tidak dibenarkan.
Contoh: Tarikh Mengilang:
Maklumat-maklumat yang perlu dicetak pada lain panel
9. Pernyataan Penyimpanan dan Pembuangan
i)
ii)
Tatacara penyimpanan, Pembuangan Sakibaki racun serta maklumat-maklumat
berhubung dengan tindakan yang perlu dilaksanakan sekiranya berlaku
kebocoran, tumpahan atau kerosakan pada racun makhluk perosak.
Pembuangan bekas. Di samping pernyataan rasmi pembuangan bekas, arahan
menghendaki pengguna terlebih dahulu melaksanakan proses pembersihan
secara membilas tiga kali. Bagi perumusan aerosol, frasa perihal pembuangan
bekas digantikan dengan “JANGAN TEBUK ATAU BAKAR BEKAS
AEROSOL”. Bagi perumusan kepingan dan lingkaran, perkara (9)(ii) adalah
dikecualikan.
10. Aturan Penggunaan (Contoh: Lihat lampiran 1)
Melainkan bahan-bahan teknikal atau mana-mana bahan yang ditetapkan oleh
Lembaga, label racun makhluk perosak hendaklah mengandungi arahan-arahan yang cukup
dalam bentuk jadual berhubung dengan aturan penggunaannya.
Ini termasuk maklumat-maklumat berhubung dengan cara membancuh, cara
menggunakannya, jarak masa dan kekerapan semburan atau rawatan. Ini diikuti dengan
pernyataan tempoh dilarang mengutip hasil atau menyembelih ternakan atau meragut rumput
atau mengedar selepas semburan atau rawatan terakhir racun makhluk perosak. Di mana
berkenaan tempoh masa masuk semula dan bilangan semburan maksimum semusim juga perlu
dinyatakan.
Maklumat-maklumat lain pada label termasuklah piktogram-piktogram berkaitan dan
butir-butir lain yang releven mengenai sifat fizik dan biologi racun makhluk perosak
berkenaan.
33
11. Pernyataan Awas (Contoh: Lihat
lampiran 2)
Pernyataan ini merangkumi langkah-langkah keselamatan bagi tujuan menghalang
berlakunya sebarang bencana terhadap manusia dan alam sekitar. Ia perlu dijelaskan secara
terperinci di bawah perkara-perkara berikut:
(i)
bahaya kepada manusia. Penekanan hendaklah diberi berhubung dengan
kemungkinan bahaya disebabkan termakan atau terminum, serapan kulit,
terhidu dan lain lain bersangkutan. Pernyataan berkaitan bentuk atau jenis
pakaian serta peralatan perlindungan yang perlu diguna ketika
mengendalikannya juga perlu dijelaskan.
(ii)
bahaya pada alam sekitar. Tumpuan perlu diberi terhadap kesan keracunan
pada binatang atau hidupan liar atau tumbuhan berfaedah dan berguna
selain sumber atau saliran atau kawasan tadahan air. Ini termasuk
pernyataan jarak zon larangan penggunaan racun makhluk perosak bagi
kawasan- kawasan berhampiran dengan sumber air ataupun kawasan
tadahan air. Lembaga boleh menetapkan pernyataan awas yang lain atas
alasan kepentingan awam.
12. Pengelasan Racun Perosak/Pita Warna
Setiap label hendaklah menunjukkan pita warna berdasarkan pada kelas yang
diperuntukkan oleh Lembaga termasuk kata hemat, pernyataan dan simbol-simbol amaran yang
dihubungkaitkan dengan kumpulan kelas serta sifat-sifat bahan berkenaan.
Kelas yang ditetapkan bagi racun makhluk perosak iaitu KELAS Ia, KELAS
Ib,KELAS II, KELAS III atau KELAS IV hendaklah dicetak dalam huruf besar dan tebal
ditengah-tengah pita warna dengan cetakan berada di kawasan ruang panel utama. Pita warna
hendaklah dicetak di sekeliling bahagian label yang paling bawah dan hendaklah mempunyai
ketinggian minimum berukuran 10 peratus daripada keseluruhan ketinggian label dengan
syarat bahawa saiz font cetakan huruf-huruf itu tidaklah kurang daripada 9 poin serta
mengadakan simbol-simbol amaran yang diperuntukkan bagi kelas atau sifat racun makhluk
perosak berkenaan.
13. Amaran & Kata Hemat
Pernyataan mengenai amaran dan kata hemat yang sesuai bagi kelas yang ditetapkan
bagi racun makhluk perosak sebagaimana dinyatakan hendaklah dicetak dalam Bahasa
Malaysia dan tiga lagi bahasa tempatan pada pita warna.
Contoh: JAUHKAN DARIPADA MAKANAN DAN KANAK-KANAK
34
14. Maklumat-maklumat lain
Suatu pernyataan ringkas mengenai tanda keracunan, rawatan kecemasan dan rawatan
perubatan.hendaklah dicetak pada label. Bagi pernyataan rawatan perubatan, ia perlu dicetak
dalam versi Bahasa Malaysia dan Bahasa Inggeris.
14.1. Jenis ‘Font’ dan Bahasa
‘Font’ yang disyorkan untuk cetakan ialah jenis ‘Bookman’ pada saiz
sekurang-kurangnya 9 ‘poin’. Pastikan bahasa Malaysia yang digunakan adalah
menurut kaedah semasa. Semua ejaan, tanda bacaan(punctuations), gaya
bahasa(expressions) dan maklumat-maklumat dicetak dengan betul dan sempurna.
14.2. Keperluan untuk ‘Extended Label’
Sekiranya label yang dicadangkan mengguna bentuk persembahan ‘extended
label’, pastikan pernyataan berikut dicetak pada panel yang melekat pada
pembungkusan produk. Tertakluk pada ruang sedia ada, turutan pernyataan menurut
keutamaan yang perlu dicetak adalah AWAS, TANDA TERKENA RACUN,
RAWATAN KECEMASAN, RAWATAN PERUBATAN & MEDICAL
TREATMENT baru diikuti dengan PERNYATAAN PEMBUANGAN.
Disamping itu, pastikan juga maklumat asas lain seperti Perawis Aktif
(termasuk % w/w), Perumusan, No. Pendaftaran , Nama Dagangan dan Nama Syarikat
yang mendaftarkannya serta No. telefon syarikat (tanpa alamat) dicetak sekali lagi pada
panel tersebut termasuk pita warna kelas sekiranya bentuk persembahan panel utama
label berkenaan tidak melekat pada pembungkusan yang dimaksudkan. Pastikan bentuk
persembahan termasuk saiz label yang dikemukakan, adalah sama seperti label yang
akan digunakan pada pembungkusan produk berkenaan.
14.3. Penggunaan Logo
Hanya logo syarikat dan logo produk sahaja dibenarkan dicetak pada label.
Logo syarikat hendaklah dicetak pada ruang sebelah kanan atau kiri nama & alamat
syarikat yang mendaftar. Ketinggian logo ini tidak boleh melebihi ketinggian ruang
cetakan nama & alamat syarikat. Logo produk boleh dicetak sama ada disebelah kanan
atau kiri nama dagangan dengan ketinggian logo tidak melebihi 50% daripada
ketinggian huruf nama dagangan. Cetakan kedua-dua logo tidak boleh berulang
walaupun logo yang sama. Logo-logo lain tidak dibenarkan iaitu termasuk Logo
SIRIM, ISO dan sebagainya melainkan mendapat kelulusan di mana tempoh kelulusan
adalah sama atau labih dengan tempoh kelulusan racun perosak yang didaftarkan..
Sebarang bentuk promosi ataupun yang dianggap berunsur iklan adalah tidak
dibenarkan dicetak pada label
15. Pihak Lembaga adalah berhak untuk membuat sebarang tambahan atau
perubahan dalam Garis Panduan ini dari semasa ke semasa jika difikirkan
perlu.
35
a) CONTOH DRAF LABEL- Gred Teknikal Untuk Tujuan Perkilangan
TRADE NAME
RACUN MAKHLUK PEROSAK
BAHAN TEKNIKAL (TC)
GRED TEKNIKAL UNTUK TUJUAN PERKILANGAN SAHAJA
(TECHNICAL GRADE FOR MANUFACTURING PURPOSES ONLY)
Perawis Aktif: xxxxxxxxxx ......……………….... xx.xx% w/w
Perawis Lengai: …………………………………..... x.x% w/w
Didaftarkan oleh:
NAMA SYARIKAT. (XXXXX-X)
Alamat 1,
Alamat 2,
Poskod, Negeri.
Tel.: xx-xxxxxxx
Faks: xx-xxxxxxx
Email:[email protected]
No. Pendaftaran: LRMP. R1/
Tarikh Mengilang:
Kandungan Bersih: x kg
Jika berlaku KERACUNAN, sila hubungi:
PUSAT RACUN NEGARA - 1-800-88-8099 (waktu pejabat)
- 012-4309499 (lepas waktu pejabat)
BACA LABEL SEBELUM GUNA
BERBAHAYA
JAUHKAN DARIPADA
MAKANAN
DAN
KANAK-KANAK
KELAS III
HARMFUL
KEEP AWAY FROM
FOODSTUFF AND
CHILDREN
36
AWAS:
a) Bahaya Kepada Manusia: Berbahaya jika tertelan. Elakkan daripada terhidu wasap. Elakkan
daripada terkena pada kulit dan mata. Ketika mengendalikan produk ini, JANGAN makan,
minum atau merokok. Selepas mengendalikan produk ini, pastikan basuh badan sebersihbersihnya dengan sabun dan air. Tutup bekas racun dengan rapat dan simpan di tempat
berkunci yang mempunyai peredaran udara yang baik, kering dan dingin.
Pakaian dan Alat Perlindungan: Ketika mengendalikan produk ini, pastikan pakai pakaian
pelindung diri (PPE) berpiawaian termasuk sarung tangan, gogal, penutup muka dan alat
pernafasan (respirator).
b) Bahaya Pada Alam Sekitar: Produk ini adalah berbahaya pada organisma akuatik dan ikan.
JANGAN cemarkan kolam, sungai atau saliran air dengan tumpahan, sisa-sisa bahan atau
larutan pencuci.
TANDA KERACUNAN:
Gatal-gatal pada mata atau kulit.
RAWATAN KECEMASAN:
Tanggalkan pakaian yang terkena racun. Jika terkena pada kulit, basuh dengan menggunakan
sabun dan air. Jika terkena pada mata, bersihkan dengan menggunakan air bersih yang banyak
selama sekurang-kurangnya 15 minit. Jika tertelan, ikhtiarkan supaya pesakit itu muntah
dengan menjolok jari ke dalam kerongkong selepas diberi minum air. Jangan beri apa-apa
melalui mulut dan jangan ikhtiarkan pesakit itu muntah jika dia tidak sedar. Dapatkan rawatan
perubatan dengan segera.
RAWATAN PERUBATAN:
Rawatan hendaklah mengikut tanda sakit.
MEDICAL TREATMENT:
Treatment is symptomatic.
BILAS BEKAS KOSONG TIGA (3) KALI SEBELUM MELUPUSKANNYA. JANGAN
GUNAKAN BEKAS RACUN UNTUK MENYIMPAN MAKANAN.
____________________________________________________________________
VERSI CINA
KELAS III
VERSI TAMIL
37
b) CONTOH DRAF LABEL- Formulated product
TRADE NAME
SERBUK BANCUH (xx)
RACUN KULAT
Kandungan Bersih:xx kg
Perawis Aktif:
xxxxxxxxx ......................................................... x.x% w/w
xxxxxxxx ........................................................ xx.xx% w/w
Perawis Lengai:
............................................................................. xx.xx% w/w
No. Pendaftaran: LRMP. R1/
Tarikh Mengilang:
Didaftarkan oleh:
NAMA SYARIKAT. (XXXXXX-X)
Alamat 1,
Alamat 2,
Poskod, negeri.
Tel.: xx-xxxxxxxx
Faks: xx-xxxxxxx
Email: [email protected]
Jika berlaku KERACUNAN, sila hubungi:
PUSAT RACUN NEGARA: 1-800-88-8099 (waktu pejabat)
012-4309499 (lepas waktu pejabat)
BACA LABEL SEBELUM GUNA
KELAS IV
KEEP AWAY
FROM FOODSTUFF
AND CHILDREN
JAUHKAN
DARIPADA
MAKANAN DAN
KANAK-KANAK
VERSI TAMIL
VERSI CINA
38
ATURAN PENGGUNAAN: TRADE NAME ialah racun xxxxxxxxxxx pracampuran daripada kumpulan xxxxxxxxxxxxxxx
dan xxxxxxxxxxxxx yang bertindak memberi perlindungan kepada tanaman. Racun xxxxxxxx ini berkesan untuk kawalan
xxxxxxxxxxxxx seperti yang tercetak pada label.
Penggunaan tidak mengikut label adalah satu kesalahan.
KADAR RACUN
TANAMAN
JENIS xxxxxxxxxx
xxxxxxxxxx
xxxxxxxxxxx
(xxxxxxxxxxxxxxx)
10 liter air
Sehektar
xx g
xx kg
ISI PADU
SEMBURAN
SEHEKTAR
BILANGAN
SEMBURAN
MAKSIMUM
xx liter
x kali semusim
Jangan kutip hasil tanaman yang disyorkan sekurang-kurangnya xx hari selepas semburan terakhir.
Tidak boleh digunakan pada peringkat mengutip hasil bagi tanaman xxxxx.
Panduan Membancuh: Disyor menggunakan alat penyembur galas. Isikan tangki setengah penuh dengan air bersih.
Campurkan TRADE NAME secukupnya mengikut syor yang ditetapkan dalam jadual sukatan dan bancuh. Seterusnya
tambah baki air bersih yang diperlukan dan kacau. Jangan guna pada kadar yang lebih tinggi dari yang disyorkan.
Panduan Menyembur: Lakukan semburan apabila tanda-tanda penyakit mulai kelihatan. Untuk kawalan yang baik, sembur
secara menyeluruh ke atas daun. Ulangi semburan selang x hari sekali apabila serangan masih berkekalan. Jika rawatan perlu
diulangi, gunakan TRADE NAME berselang-seli dengan racun kulat yang mempunyai cara tindakan yang berbeza.
Tempoh Dilarang Masuk Semula Kawasan Rawatan (REI): xx jam
AWAS: a) Bahaya Kepada Manusia: Berbahaya jika termakan. Elakkan daripada terhidu debu atau kabus semburan.
Elakkan daripada terkena pada kulit atau mata. Ketika mengendalikan produk ini, JANGAN makan, minum atau merokok.
Selepas mengendalikan racun ini, pastikan basuh badan sebersih-bersihnya dengan sabun dan air. Tutup bekas racun dengan
rapat dan simpan di tempat berkunci yang mempunyai peredaran udara yang baik, kering dan dingin. Cuci tangan dan alat
penyembur sebersih-bersihnya selepas menggunakannya.
Pakaian dan Alat Perlindungan: Ketika mengendalikan produk ini, pastikan pakai pakaian pelindung diri (PPE) berpiawaian
termasuk sarung tangan, gogal, penutup muka dan alat pernafasan (respirator) supaya tidak terhidu kabus semburan.
b) Bahaya Pada Alam Sekitar: Produk ini adalah berbahaya pada organisma akuatik dan ikan. JANGAN cemarkan kolam,
sungai atau saliran air.
TANDA KERACUNAN: Pendedahan yang berlebihan menyebabkan mual, muntah dan gatal-gatal kerongkong dan kulit.
RAWATAN KECEMASAN: Tanggalkan pakaian yang terkena racun. Jika terkena pada kulit, basuh dengan menggunakan
sabun dan air. Jika terkena pada mata, bersihkan dengan menggunakan air bersih yang banyak selama sekurang-kurangnya 15
minit. Jika tertelan, ikhtiarkan supaya pesakit itu muntah dengan menjolok jari ke dalam kerongkong selepas diberi minum air.
Jangan beri apa-apa melalui mulut dan jangan ikhtiarkan pesakit itu muntah jika dia tidak sedar. Dapatkan rawatan perubatan
dengan segera.
RAWATAN PERUBATAN: Rawatan hendaklah mengikut tanda sakit.
MEDICAL TREATMENT: Treatment is symptomatic.
BILAS BEKAS KOSONG TIGA (3) KALI SEBELUM MELUPUSKAN. JANGAN GUNAKAN BEKAS RACUN UNTUK
MENYIMPAN MAKANAN.
39
c) CONTOH DRAF LABEL- Formulated product- Highly Toxic Pesticides (HTP)
PENGENDALIAN DAN PENGGUNAAN PRODUK INI ADALAH
TERTAKLUK KEPADA PERATURAN-PERATURAN RACUN MAKHLUK
PEROSAK (RACUN MAKHLUK PEROSAK AMAT BERBISA) 1996
TRADE NAMA
PEKATAN LARUT AIR (SL)
RACUN SERANGGA
Kandungan Bersih:x kg
Perawis Aktif:
xxxxxxxxxxxxxxx ................................................
xx.0% w/w
Perawis Lengai:
................................................................................
xx.0% w/w
No. Pendaftaran: LRMP. R1/
Tarikh Mengilang:
Didaftarkan oleh:
NAMA SYARIKAT. (XXXXXXX-X)
Alamat 1,
Alamat 2,
Poskod, Negeri .
Tel.: xx-xxxxxxx
Faks: xx-xxxxxxxx
Email: [email protected]
Jika berlaku KERACUNAN, sila hubungi:
PUSAT RACUN NEGARA: 1-800-88-8099 (waktu pejabat)
012-4309499 (lepas waktu pejabat)
BACA LABEL SEBELUM GUNA
KELAS Ia or Ib (SKULL)
VERY HIGHLY POISONOUS
BERACUN-AMAT BISA
KEEP AWAY
FROM FOODSTUFF
AND CHILDREN
JAUHKAN
DARIPADA
MAKANAN DAN
KANAK-KANAK
VERSI TAMIL
VERSI CINA
40
TRADE NAMA ialah racun xxxxxxxxxxxxxx jenis ‘xxxxxxx’ sistemik yang bertindak secara sentuhan dan keracunan perut.
ATURAN PENGGUNAAN: Penggunaan tidak mengikut label adalah satu kesalahan.
CARA RAWATAN
TANAMAN
SERANGGA
xxxxx
xxxxx (xxxxxxxxxxx)
xxxxx(xxxxxxxxxxxxx)
xxxx
KADAR RACUN
SEPOKOK
xx ml
Xxxxxxxxxx (xxxxxxxxxxxxxx)
Lakukan suntikan apabila terdapat
serangan melebihi tahap ambang
tindakan (ATL). Tebuk lubang pada
sudut xx° sedalam xxxxx cm dengan
lebar xxxx cm pada batang pokok. Jarak
lubang dari tanah adalah lebih kurang x
kaki. Suntikkan xxx ml TRADE NAME
dan tutup lubang dengan tanah dan
plastisin.
Jangan kutip hasil tanaman xxxxxxx sekurang-kurangnya x hari selepas rawatan suntikan batang dan xx hari bagi
tanaman xxxxxxxxxxx.
Tempoh Dilarang Masuk Semula Kawasan Rawatan (REI): xx jam
AWAS: a) Bahaya Kepada Manusia: Berbahaya jika terminum. Elakkan daripada terhidu wasap. Elakkan daripada terkena
pada kulit atau mata. Ketika mengendalikan produk ini, JANGAN makan, minum atau merokok. Selepas mengendalikan
produk ini, pastikan basuh badan sebersih-bersihnya dengan sabun dan air. Tutup bekas racun dengan rapat dan simpan di
tempat berkunci yang mempunyai peredaran udara yang baik, kering dan dingin. Cuci tangan dan alat penyuntik sebersihbersihnya selepas menggunakannya.
Pakaian dan Alat Perlindungan: Ketika mengendalikan produk ini, pastikan pakai pakaian pelindung diri (PPE) berpiawai
termasuk sarung tangan, gogal, penutup muka dan alat pernafasan (respirator) supaya tidak terhidu kabus semburan.
b) Bahaya Pada Alam Sekitar: Produk ini adalah berbahaya pada organisma akuatik dan ikan. JANGAN cemarkan kolam,
sungai atau saliran air.
TANDA KERACUNAN: Berpeluh, sakit kepala, pening, pandangan kabur, kajang otot, mual, muntah, sesak nafas, cirit-birit
dan beser ludah.
RAWATAN KECEMASAN: Tanggalkan pakaian yang terkena racun. Jika terkena pada kulit, basuh dengan menggunakan
sabun dan air. Jika terkena pada mata, bersihkan dengan menggunakan air bersih yang banyak selama sekurang-kurangnya 15
minit. Jika tertelan, ikhtiarkan supaya pesakit itu muntah dengan menjolok jari ke dalam kerongkong selepas diberi minum air.
Ulangkan sehingga air muntah menjadi jernih. Jangan beri apa-apa melalui mulut dan jangan ikhtiarkan pesakit itu muntah jika
dia tidak sedar. Dapatkan rawatan perubatan dengan segera.
RAWATAN PERUBATAN: Suntikkan Atropina Sulfat (2-4 mg) secara intravena atau intraotot. Ulang setiap 30 minit
sehingga pesakit itu pulih dengan sepenuhnya. Kemudian suntikkan pralidoksim (1 g) secara intravena, jika perlu.
MEDICAL TREATMENT: Inject Atropine Sulphate (2-4 mg) intravenously or intramuscularly. Repeat every 30 minutes
until the patient is fully atropinised. Then, administer pralidoxime (1 g) intravenously, if necessary.
BILAS BEKAS KOSONG TIGA (3) KALI SEBELUM MELUPUSKAN. JANGAN GUNAKAN BEKAS RACUN UNTUK
MENYIMPAN MAKANAN.
41
PERNYATAAN AMARAN , KATA HEMAT DAN WARNA PITA
42
GARIS PANDUAN UNTUK NAMA DAGANGAN PRODUK YANG DIDAFTAR DI
BAWAH AKTA RACUN MAKHLUK PEROSAK 1974
1.0 Tujuan
Memperkemaskan perlaksanaan arahan-arahan dan peraturan-peraturan berhubung dengan
nama dagangan produk racun perosak yang didaftarkan di bawah Akta Racun Makhluk
Perosak 1974
2.0 Panduan
2.1 Tatacara Menamakan
2.1.1
Penggunaan nama dagangan yang sama bagi mana-mana produk adalah
tidak dibenarkan, tidak kira sama ada ianya didaftar oleh syarikat yang
sama atau berlainan. Ini termasuk tidak membenarkan satu lagi syarikat
lain menggunakan nama dagangan yang sama walaupun dengan adanya
surat kebenaran daripada syarikat berkenaan.
2.1.2
Sebarang nama dagangan sama ada sebahagian ataupun
keseluruhannya
yang boleh dikaitkan dengan nilai komersial,
keselamatan racun perosak, alam sekitar ataupun nilai sosio budaya
masyarakat tempatan adalah tidak dibenarkan. Ini termasuk perkataanperkataan superlatif atau yang boleh membawa erti pada keunggulan
sesuatu produk sama ada dalam bentuk bunyi ataupun sebaliknya.
Beberapa contoh berhubung dengan keperluan perkara 2.1.2 adalah
sepertimana tercatat dalam Lampiran A.
2.1.3
Angka atau nombor bebas digunakan melainkan sebahagian nama
dagangan itu mempunyai nama bahan aktif atau penggunaan perumusan
sebagai nama dagangan, maka angka mesti sama dengan % W/W.
2.1.4
Produk yang menggunakan nama bahan aktif sebagai nama dagangan
mestilah menambah perkataan awalan. Antara perkataaan awalan yang
disyorkan ialah nama syarikat yang mendaftar, singkatan nama syarikat
yang mendaftar ataupun tanda perniagaan yang digunakan. Sekiranya
singkatan nama syarikat hendak digunakan sebagai perkataan awalan, ia
hendaklah mematuhi perkara 2.1.2.
2.1.5
Singkatan untuk perumusan seperti (SP, EC, ES dan sebagainya) tidak
dibenarkan penggunaannya kecuali perumusannya adalah sama dengan
singkatan itu
2.1.6
Sekiranya ungkapan atau perkataan itu sama ada sebahagian ataupun
keseluruhannya yang boleh dikaitkan dengan nilai komersial,
keselamatan racun perosak, alam sekitar ataupun nilai sosio budaya
masyarakat tempatan ataupun perkataan-perkataan superlatif seperti
43
perkara 2.1.2, dan
apabila
digabungkan
dengan ungkapan lain menjadi satu nama dagangan, maka nama itu
adalah tidak dibenarkan. Tetapi jika gabungan nama itu mempunyai
maksud yang tidak melanggar perkara 2.1.2, setelah dirujuk dalam
kamus, maka ia adalah dibenarkan. Contohnya: PROCLAIM,
PROTECT, BLACKTOP
2.1.7
Penggunaan tanda perniagaan “trademark” sebagai nama dagangan
adalah dibenarkan dengan syarat ia dapat mematuhi perkara 2.1.2 dan
penggunaan negara asal tidak dibenarkan dicetak pada label melainkan
negara Malaysia. Contoh:
®Trademark of Xyz (Malaysia) Sdn. Bhd.(dibenarkan)
®Trademark of Xyz (Japan, Germany) (tidak dibenarkan)
2.1.8
Nama khas produk yang terkenal bagi komoditi lain, tidak dibenar untuk
didaftarkan sebagai nama dagangan racun perosak.
2.1.9
Semua pendaftaran racun perosak teknikal sedia ada yang mendaftar
nama dagangan yang sama dikehendaki menambah perkataan awalan.
Perkataan awalan hendaklah mematuhi perkara 2.1.4.
2.1.10 Sebarang nama dagangan yang berkaitan dengan peperangan, keganasan
dan kepahlawanan adalah tidak dibenarkan. Contoh: JET, BOMB,
BAZOOKA, NINJA, PENDEKAR, SILAT SERANG, RAID,
DESTROY dan sebagainya.
2.1.11 Pihak Lembaga adalah berhak untuk menolak sebarang nama dagangan
yang dianggap tidak sesuai untuk didaftarkan dari semasa ke semasa jika
difikirkan perlu.
2.2 Nama Naungan
2.2.1 Pengawalan nama naungan atau cap dagangan ataupun tanda
dagangan sama ada dipaten atau didaftar dengan mana-mana
pihak berkuasa sama ada di dalam negeri ataupun peringkat
antarabangsa adalah di luar bidang kuasa Lembaga dan pihak
Lembaga tidak terikat pada mana-mana kehendak pihak
berkuasa berkaitan.
2.2.2 Walau bagaimanapun, sekiranya masih ingin mencadangkan
satu-satu tanda nama sebagai nama naungan atau cap dagangan
ataupun tanda dagangan yang dimaksudkan, pihak yang
mendaftar dikehendaki memaklumkan secara bertulis untuk
diberi pertimbangan sebelum ianya dibenarkan. Tanda nama
berkenaan perlu terlebih dahulu mematuhi kehendak perkara
2.1. Satu salinan akuan dari Pejabat Pendaftar berhubung dengan
pendaftaran tanda nama tersebut adalah diperlukan.
44
2.3 Bentuk dan Corak Cetakan
2.3.1 Nama dagangan bagi satu-satu produk mesti dicetak dengan
terang dan jelas. Ia perlulah sama dengan nama dagangan yang
diwartakan dan dinyatakan dalam sijil pendaftaran.
2.3.2 Nama dagangan hendaklah dicetak dengan menggunakan jenis
dan saiz huruf yang sama besar. Sekiranya saiz huruf berlainan,
perbezaan saiz dari segi ketinggiannya mestilah tidak lebih dari
30 %.
2.3.3 Kesemua huruf pada nama dagangan perlu dicetak dalam warna
dan kepekatan yang sama.
2.3.4 Sebarang reka bentuk atau penanda pada nama dagangan,
termasuk warna latar belakangnya hendaklah sama serta
diseragamkan bagi semua huruf.
2.3.5 Sekiranya nama dagangan mengandungi lebih dari satu
perkataan, kedudukan cetakan mestilah tidak terlalu jauh.
3.0 Maklumat lain
3.1 Semua Garis Panduan untuk nama dagangan ini adalah berkuatkuasa bagi
permohonan baru sahaja. Walau bagaimanapun bagi pendaftaran semula,
hanya perkara 2.19 dan 2.3 dalam garis panduan ini perlu dipatuhi.
3.2 Penggunaan nama dagangan dalam versi bahasa tempatan lain sebagai bahasa
tambahan adalah tidak dibenarkan.
3.3 Walau apa juga tatacara yang dinyatakan, Lembaga berhak dan boleh menetapkan
kehendak-kehendak tambahan atau sebaliknya.
4.0 Tarikh berkuatkuasa
Garis Panduan Untuk Nama Dagangan ini mula berkuatkuasa pada
15 Ogos 2005 maka dengan itu, Garis Panduan Untuk Nama Dagangan 2003 dibatalkan.
45
Lampiran A
Antara beberapa contoh perkataan yang tidak dibenarkan sebagai sebahagian daripada
nama dagangan ataupun sebaliknya
ACE; S;
EXTREME; XTREME
PLUS; PLAS
BAGUS
GREEN; GREEN LABEL
PANTAS
BEST; BEZ; BES
HAPUS
POWER
CHAMPION
JUARA
RAJA
CEKAP
JAGUH
SAFE
DOUBLE
KING
SMART
EKO; ECO
K.O
SPECIAL; STAR
ELITE
KUASA
SUPER; GOLD
EXCEL
KUAT; QUAT
SUREMAX
EXTRA
MAX
ULTRA
FAST; FAS;
TOP
WIRA; SATRIA
EXCELLENCE
PRO
ARSENAL; PROTON
PROFIT
NATURAL;
SEMULAJADI
ABADI
BIO
ENERGY
KILL; KILLER
NO. 1
ZAP
ASLI; ORI; ORIGINAL
FLORA; FAUNA
ENVIRO
HERO
46
GP 1/2015
GUIDELINES ON
PRODUCT CHEMISTRY DATA REQUIREMENTS
FOR
PESTICIDE REGISTRATION
Pesticides Board
Malaysia
2015
47
Lampiran A
PRODUCT CHEMISTRY DATA REQUIREMENTS
GLOSSARY
ACTIVE INGREDIENT : an ingredient, as listed in the First Schedule, in the Pesticides Act 1974 (Act 149),
which has pesticidal properties and gives pesticidal properties to a substance, material, preparation or mixture, of
which the ingredient is one of the constituents of substance, material, preparation of mixture.
INERT INGREDIENT also named FORMULANT: any substance other than an active ingredient, which is
intentionally included in a pesticide product.
TECHNICAL GRADE OF ACTIVE INGREDIENT (TGAI) also named TECHNICAL MATERIAL (TC):
material containing an active ingredient: together with all impurities from manufacturing process which contains
no inert ingredient and which is produced on a commercial or pilot plant production scale (whether or not it is
ever held for sale)
TECHNICAL CONCENTRATE (TK) : material consisting in an active ingredient: together with all impurities
originating from manufacturing process which contains also additives (not formulants), and or a stabilizer. For
example all safety agents and may also contain solvent(s) (including water) and which is produced on a
commercial or pilot plant production scale (whether or not it is ever held for sale)
Pure Active Ingredient (PAI) Active Ingredient which have been purified or not with a certified purity higher than
980g/kg.
FORMULATED PRODUCT: pesticide product whose labeling includes directions for use of the product ( as
distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, or
desiccating or regulating growth of plant and does not state the product may be used to manufacture of formulate
other pesticide products.
STARTING MATERIAL: a substance used to synthesize or purify a technical grade of active ingredient (or the
practical equivalent of the technical grade ingredient if the technical grade cannot be isolated) by chemical
reaction.
IMPURITY: any substance (or group of structurally similar substances) present in a pesticide product other than
an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products,
contaminants and degradation products and pesticide active ingredients other than intended for that product.
48
SIGNIFICANT IMPURITY: any impurities find in a TC or TK present at a level of 1g/kg or above.
RELEVANT IMPURITY: any impurity of the manufacture or storage of a pesticide which, compared with the
active ingredient, is toxicologically significant to health or the environment, is phytotoxic to treated plants, causes
taint in food crops, affects the stability of the pesticide, or causes any other adverse effect. An impurity may be
non relevant in one pesticide or product and relevant in another, even though it occurs in both, because relevance
is determined by impurity hazards relative to those of the active ingredient.
MANUFACTURER: as per the definition given by FAO in the International Code of Conduct, means a
corporation or other entity in the public or private sector (including an individual) engaged in the business or
function (whether directly or through an agent or entity controlled by or under contract with it) of manufacturing a
pesticide active ingredient or preparing its formulation or product. A manufacturer may well have several
different manufacturing site legally owned by different legal entities.
MANUFACTURING PLANT: means the place where a pesticide is produced.
CONFIDENTIAL BUSINESS INFORMATION (CBI): means any data with commercial value the release of
which could harm to the company’s business interest leading to unfair competition as provided for under the
Pesticides Act 1974 (Act 149).
Product Chemistry Data Requirement for manufacsticide Registration
1.
INTRODUCTION
Data requirements on product chemistry include information on the manufacturer, and the
manufacturing(s) plants, manufacturing process and manufacturing limits, product composition,
chemical and physical properties of the pesticides as well as Method of analysis of the pesticides.
These data among other things are required to:
a)
support the claims made by the applicant;
b)
enable registration authorities to evaluate the pesticide in terms of its quality, potential
hazards, decomposition products etc;
c)
enable registration authorities to evaluate the pesticide and specify labeling and
packaging requirements; and
d)
support emergency requests on spillage, fire, poisoning etc.
49
2.
DATA
REQUIREMENTS
FOR
TECHNICAL
GRADE
OF
ACTIVE
INGREDIENT (TC/TK)- ( CONFIDENTIAL BUSINESS INFORMATION)
2.0
Originator
2.0.1.
Manufacturer of the active ingredient.
Name and address of Manufacturer.
2.1.
Identity and Composition
2.1.1
Common Name
I.
The common name of the active ingredient(s) shall be clearly stated as listed in First
Schedule (Section 2) of the Pesticides Act 1974.
II.
The ISO common name of the active ingredient(s) shall be stated if any. If no ISO
common name is available, then the common name used by Malaysian Standard or
other common name as proposed by other organizations (British Standard Institution
(BSI), etc.) may be used. (if not ISO name, must be specified clearly)
III.
For products containing biopesticides (microorganism), for example Bacillus
thuringiensis, the scientific systematic name subspecies and strains of the organism
shall be given. Please refer to the relevant guidelines (Guidance For Harmonizing
Pesticide Regulatory Management in Southeast Asia, 2012/2013), website:
http://www.fao.org/asiapacific and Asean Guidelines On The Regulation, Use and
Trade of Biological Control Agent (BCA)
2.1.2
I.
Chemical Name
The International Union of Pure and Applied Chemistry (IUPAC) chemical name shall
be used.
II.
CAS number shall be stated and in addition Collaborative International Pesticides
Analytical Council number (CIPAC number) shall also be given if available.
III.
CAS number for each isomer or the mixture of isomers shall be stated.
50
2.1.3
I.
Chemical Formula
The molecular formula, molecular mass and structural formula of the active ingredient
including its salt or ester wherever applicable shall be provided.
ii. Proprietary names, synonyms and code names and CIPAC number to be provided
as a guide to identify the products (if applicable).
iii. Chemical and physical properties of the technical material shall be provided. (Refer
Appendix 1).
iv. The Safety Data Sheet (SDS) of the Technical Grade of Active Ingredient shall be
provided. The Safety Data Sheet (SDS) given must according to the Occupational
Safety and Health (Classification, labeling and Safety Data Sheet of Hazardous
Chemicals Regulation 2013),
2.2

The minimum information in appendix 2 shall be included on SDS

Additional information may be required by Pesticide Board.
Manufacturing Process
The manufacturing activity shall be stated clearly where;
(a) The name and address of the manufacturing plant at which the pesticide will be
produced,
(b) For technical materials (TC), the manufacturing process starting from the starting
materials, partway, by product and impurities shall be provided. Chemical equations
for chemical reactions involved in the manufacturing process shall also be provided.
The purity of each starting material used to produce technical material also shall be
provided.
(c) A description of any purification procedures (including procedures to recover or
recycle starting materials, intermediates or the substance produce) shall be
provided.
51
(d) A description of the procedures used to ensure consistent composition of substance
produces, e.g., calibration of equipment, sampling regimens, analytical methods or
other quality control methods shall be stated clearly.
(e) For each starting material, chemical name, CAS number, or other commercial
designation of ingredient;
I.
All information that applicant knows concerning the composition (and, if
requested by the Pesticide Board), chemical and physical properties of the
ingredient, including a copy of technical specifications, Safety Data Sheet
(SDS) or other document describing the ingredient.
(f) Flowchart of the process of manufacturing process of the pesticide shall be
submitted with the application. Summarizing the conditions and solvent employed
also shall be provided.
(g) For technical materials, minimum active ingredient and manufacturing maximum
limits for impurities content shall be stated in g/kg.
(h) Information on relevant impurities with explanation of the effects observed (for
example, toxicological effects, or effects on the stability of the active ingredient)
shall be provided. Limits set by FAO/WHO Joint Meeting on Pesticide
Specifications (JMPS) and/or registration authorities shall accompany this
information, identifying the authority responsible for setting the limit.
(i) For technical material, manufacturing maximum limits for significant impurities
present at or above 1g/kg, supported by batch analysis data (minimum 5 typical
batches). The statistical basic for manufacturing limits (confidential data) shall be
given. 5 batch studies are required to be Good Laboratory Practices (GLP) studies.
Relevant impurities must be identified in the submission.
Typically the
unidentified and/or unaccountable fraction of TC/TK should not exceed 20g/kg
(j) Manufacturing maximum limits for impurities proposed as relevant at < 1g/kg.
Maximum limits for these impurities shall also supported with batch analytical data
(minimum 5 typical batches) (all confidential) and proposer shall state the
statistical basic for manufacturing limits
52
(k) The certification statement shall be signed by an authorized representative of the
manufacturer.
2.3 Method For Analysis and Testing of Technical Grade Active Ingredient.
I.
Validated analytical procedures for determination of the content of active ingredient
and content of impurities of toxicological concern in the product shall be provided.
Procedures involving use of carcinogenic reagents would not be acceptable. Sources or
authorities from which the analytical procedure is extracted shall be mentioned.
II.
At least two methods for the identification of the active ingredient shall be provided.
III.
Reference test methods for physical properties. Test methods for physical properties
may be validated by Collaborative International Pesticides Analytical Council (CIPAC)
or American Society for Testing and material (ASTM), or according to the
requirements of Organization for Economic Co-operation and Development (OECD) or
European Community (EC), or, where appropriate by pharmaceutical organizations.
IV.
Analytical standards required for the use of the analytical methods mentioned shall be
supplied with the application.
(Refer to Appendix 6 Requirement for analytical
standard.)
2.4
Packing
I.
The type of packing material used shall be stated.
II.
The packaging shall comply with Malaysian Standard (MS 409:2012), Code of Practice
for Packaging and Storage of Pesticide, and other international standard.
III.
If the packaging does not comply with the Malaysian Standard (MS 409:2012), Code
of Practice for Packaging and Storage of Pesticide, the results of a quality evaluation
test shall be provide.
53
2.5
Evidence of Stability on Storage of Technical Grade Of Active Ingredient Technical
Concentrate (TK)
I.
Analytical Test Report as evidence of stability on storage shall be submitted with each
application. Stability tests shall be conducted in accordance with the FAO Accelerated
Storage Test Procedures usually at 54 ± 2o C for 14 days or at 45 ± 2o C for 6 weeks or
at 40 ± 2o C for 8 weeks or at 35 ± 2o C for 12 weeks or at ambient temperature
(Malaysian) for 2 years.
II.
Samples should be analyzed before and after testing using the same batch.
III.
For a critical scientific assessment of these data to be taken, each study must be
reported in sufficient detail. The methodology used in each test must be thoroughly
described, or if the study has been conducted to an internationally recognized protocol
without significant deviations, then a reference to this method will be sufficient.
IV.
Storage stability studies are required to be performed in Good Laboratory Practices
(GLP) certified test facilities or in ISO accredited laboratories.
2.6
Specifications
I.
Specifications for the Technical Grade Active Ingredient shall be provided.
The
pesticide shall conform to Malaysian Regulation, FAO or WHO requirements or FAO
or WHO specifications whenever such specifications are available. This should be
indicated in the application form. When such specifications are not available, the
applicant shall state the specification that the pesticide complies with.
II.
If the pesticide does not comply with any specifications, the reasons for noncompliance must be given with the application. (Refer to Appendix 3 for details
required in the specification )
54
3. DATA REQUIREMENTS FOR FORMULATED PRODUCTS (CONFIDENTIAL BUSINESS
INFORMATION)
Data for Technical Grade of Active Ingredient (TGAI) is required on cases where TGAI is not
registered with Pesticide Board but its formulated product (ready-made) is directly imported and is
intended to be registered. In this case, the registrant must declare the source of the technical grade
active ingredient and provide a letter of undertakings/authorization;

That it is the sole source

That if an alternative source is subsequently utilized, prior approval must be obtained from
the Board.
3.1
I.
Information on the Active Ingredients
Chemical Systematic Name, ISO common name, synonyms and code names to be provided as a
guide to identify the products.
II. Chemical and physical properties of the formulated product shall be provided. (Refer Appendix
4).
III. The Safety Data Sheet (SDS) of the proposed formulated product shall be provided. The Safety
Data Sheet (SDS) is according to the Occupational Safety and Health (Classification, labeling
and Safety Data Sheet of Hazardous Chemicals) Regulation 2013, CLASS Regulations.

The minimum information in appendix 2 shall be included on SDS.

Additional information may be required by Pesticide Board.
3.2 Manufacturing Process on Formulated Product
I.
The manufacturing activity shall be stated clearly and the following information must be
provided:
a) The name and address of the manufacturing plant who uses the process.
b) A general characterization of the process (e.g., whether it is a batch or continuous process)
55
c)
A description of the procedures used to assure consistent composition of substance
produces, e.g., calibration of equipment, sampling regimens, analytical methods or other
quality control methods should be stated clearly
d) Flowchart of the process of manufacturing the pesticide shall be submitted with the
application. Summarizing the conditions and solvent employed also shall be provided.
e) The following information must be submitted on the material used to produce the product :

The % w/w purity of technical materials used shall be indicated.

The identity of every ingredient in the formulated product shall be stated and
its concentration given in g/kg for solid formulation or g/L for liquid
formulation as per recommended by FAO and in %w/w.

Proposed target limits for the inert ingredients in the product including range of
variability for those inert ingredients which vary from batch to batch due to
adjustment of the corresponding physical parameter:,

An upper and lower limit for each active ingredient in line with the Malaysian
Regulation and FAO/WHO tolerances.
f) The following information must be submitted on certain inert ingredient:

Brand name, trade name, common name or other commercial designation of
ingredient.

All information that applicant known (or that is reasonably available to him)
concerning the composition (and, if requested by Pesticides Board, chemical
and physical properties) of the ingredient, including a copy of technical
specifications, Safety Data Sheet (SDS) or other document describing the
ingredient.
.
g)
The presence and maximum concentration of any relevant impurities and by-products in the
finished product shall be indicated.
56
3.3 Method of Analysis and Testing of Formulated Product.
i.
Validated analytical procedure for determination of the content of active ingredient and
impurities of toxicological concern in the product shall be provided. Procedure involving use
of carcinogenic reagents will not be accepted. Sources or authorities from which the analytical
procedure is extracted shall be mentioned.
ii. At least two methods for the identification of the active ingredient shall be provided.
iii. Test methods for physical properties other than Collaborative International Pesticides
Analytical Council (CIPAC) can be accepted. However, reference to the test methods shall be
stated. Test methods for physical properties may be validated by CIPAC or American Society
for Testing and Material (ASTM), or according to the requirements of Organization for
Economic Co-operation and Development (OECD) or European Community (EC), or, where
appropriate by pharmaceutical organizations.
iv. Analytical standards for active ingredient required for the above shall be supplied with the
registration application for all products. (Refer to Appendix 6 Requirement for analytical
standard.)
3.4
Packing
I.
The type of packing material used should be stated.
II. The packaging should comply with Malaysian Standard (MS 409:2012), Code of Practice for
Packaging and Storage of Pesticide or other international standard.
III. If the packaging does not comply with the Malaysian Standard (MS 409:2012), the results of a
quality evaluation report should be provided.
57
3.5
I.
Evidence of Stability on Storage
Analytical Test Report as evidence of stability on storage shall be submitted with each
application. Stability tests shall be conducted in accordance with the;
a. FAO Accelerated Storage Test Procedures is performed usually at 54 ± 2o C for 14
days or at 45 ± 2o C for 6 weeks or at 40 ± 2o C for 8 weeks or at 35 ± 2o C for 12
weeks or at 30 ± 2o C for 18 weeks when applicable or;
b. Two-Year Storage Stability (Ambient testing) to demonstrate the storage stability of a
formulation under “true” storage conditions usually over a period of 2 years. The test
shall be conducted at ambient temperature or, 20oC, 250C or 30oC dependent on the
final area of use.
ii. Samples shall be analyzed before and after testing using the same batch. The packaging used in
the study shall be based upon that in which the product is sold. If the test product is to be
supplied in different packaging material, each type shall be represented in the study or a
justification shall be given why the tested packaging material is representative of future
packaging materials.
iii. The report must include the observation of the effect on the packaging used.
iv. For a critical scientific assessment of these data to be taken, each study must be reported in
sufficient detail. The methodology used in each test must be thoroughly described, or if the
study has been conducted to an internationally recognized protocol without significant
deviations, then a reference to this method will be sufficient
v. Storage stability studies are required to be performed in Good Laboratory Practices (GLP)
certified test facilities or in ISO accredited laboratories.
58
3.6
I.
Specifications
Specifications for the product shall be provided. The pesticide shall conform to Malaysian
Regulation, FAO or WHO requirements or FAO or WHO specifications whenever such
specifications are available. This shall be indicated in the application form.
When such
specifications are not available, the applicant should state the specification that the pesticide
complies with.
II. If the pesticide does not comply with any specifications, the reasons for non-compliance must
be given with the application. (Refer to Appendix 4 for details required in the specification of a
product).
4.
I.
II.
SATISFYING DATA REQUIREMENT
The data and information submitted should be credible and valid.
Letter of consent authorizing the applicant to use the data for registration purposes must be
provided if another company’s data is submitted.
iii.
All analytical data obtained from the analysis of samples should be provided, and not just a
summary or average figure. It should be clearly stated how the data are calculated and
expressed. However, where traceability of raw data is given (archiving of row data), it is
sufficient to report the final results and information on the number of replicate analyses shall be
given.
Trivial calculations and calculations given by the test method do not need to be
reported.
5.
REPORTING OF STUDY RESULTS
5.1
General
I.
A final report should be prepared for each study. In the case of short term studies, a
standardized final report accompanied by a study specific extension may be prepared.
II.
Reports of Principal Investigators or scientists involved in the study should be signed
and dated by them.
59
III.
The final report should be signed and dated by the Study Director to indicate
acceptance of responsibility for the validity of the data. The extent of compliance with
these Principles of Good Laboratory Practice should be indicated.
IV.
Corrections and additions to a final report should be in the form of amendments.
Amendments should clearly specify the reason for the corrections or additions and
shall be signed and dated by the Study Director.
V.
Reformatting of the final report to comply with the submission requirements of a
National registration or regulatory authority does not constitute a correction, addition or
amendment to the final report.
5.2
Content of the Final Report
The final report should include, but not be limited to, the following information:
I.
Identification of the Study, the Test Item and Reference Item
a) A descriptive title;
b) Identification of the test item by code or name (IUPAC, CAS number, biological
Parameters, etc.);
c) Identification of the reference item by name;
d) Characterization of the test item including purity, stability and homogeneity.
II.
Information Concerning the Sponsor and the Test Facility
a) Name and address of the sponsor;
b) Name and address of any test facilities and test sites involved;
c) Name and address of the Study Director;
d) Name and address of the Principal Investigator(s) and the phase(s) of the study
delegated, if applicable;
e) Name and address of scientists having contributed reports to the final report.
60
III.
Dates
Experimental starting and completion dates.
IV.
Statement
A Quality Assurance Programme statement listing the types of inspections made and
their dates, including the phase(s) inspected, and the dates any inspection results were reported
to management and to the Study Director and Principal Investigator(s), if applicable. This
statement would also serve to confirm that the final report reflects the raw data.
V.
Description of Materials and Test Methods
a) Description of methods and materials used;
b) Reference to OECD Test Guideline or other test guideline or method.
VI
Results
a) A summary of results;
b) All information and data required by the study plan;
c) A presentation of the results, including calculations and determinations of
statistical significance; more detailed explanations regarding the presentation of results are
given in paragraph 4 iii above.
d) An evaluation and discussion of the results and, where appropriate, conclusions.
VII
Storage
The location(s) where the study plan, samples of test and reference items, specimens, raw data
and the final report are to be stored.
61
References
1.
Food and Agriculture Organization of United Nations and World Health Organization (2013).
International Code of Conduct on the Distribution and Use of Pesticides. Guidelines on data
requirements for the registration of pesticides.
(http://www.fao.org./agriculture/crops/corethemes/theme/pests/pm/code/guidelines/en/).
2.
World Health Organisation (2012). Guidelines for Procuring Public Health Pesticide.
(www.who.int/whopes)
3.
Food and Agriculture Organization of United Nations and World Health Organization (2006). Manual on
the development and use of FAO and WHO specifications for pesticides. Revision of 1 st ed. Rome and
Geneva. (http://whqlibdoc.who.int/publications/2006/9251048576_eng_update_2006.pdf)
4.
Government of United States of America. Data Requirements for Pesticides Registration.
(http://www.epa.gov/opp00001/regulating/data_requirements.htm)
5.
Food and Agriculture Organization of United Nations and World Health Organization (2011). Guideline
for Quality Control of pesticides.
(www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Specs/qualitycontrol05.pdf)
6.
Food and Agriculture Organization of United Nations and World Health Organization (2013). Guidance
for harmonizing pesticide regulatory management in Southeast Asia.
(http://www.apppc.org/sites/apppc.org/files/1343103031_Guidance_for_pesticide_regul-mgt_0.pdf)
7.
OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING
Document Number 1. OECD Principles on Good Laboratory Practice. (as revised in 1997)
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage]
62
Appendix 1
Chemical and Physical Properties of Purified Active Infgredients (PAI) or technical materials
(TC) required. (Required to be Good Laboratory Practices (GLP) studies;
Data Requirement
Test Substance
1. Minimum and maximum content of
Technical material (TC)
active ingredient in g/kg or %w/w
2. Identity and amounts of isomers
Technical material (TC)
3. Absorption spectra (eg.UV, IR, MS or
Purified Active Infgredients (PAI)
NMR)4. Impurities and other by products and
Technical material (TC)
their possible range expressed in g/kg or
% w/w
5. For solids; its melting point (at stated
Technical material (TC)
temperature)6. For liquids, Vapour pressure (at stated
Purified Active Infgredients (PAI)
temperature)
7. For liquids; boiling point, , specific
gravity
and
viscosity
(at
Technical material (TC)
stated
temperature)
8. Flash point
9.
Solubility in water and other solvents (at
Technical material (TC)
Purified Active Infgredients (PAI)
stated temperature)
10. n-octanol/water partition coefficient
11. Hydrolysis rate, photolysis (under stated
Purified Active Infgredients (PAI)
Technical material (TC)
conditions),
12. Stability towards oxidizing agents and
Technical material (TC)
thermal changes.
13. Dissociation constant (pKa, pKb)
Purified Active Infgredients (PAI)
Note: If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI
63
Appendix 2
The Safety Data Sheet (SDS) of the product shall include minimum information as following:
Section
Title of Section
Minimum Information
1.
Identification of the hazardous chemical and of the
(a) Product identifier;
supplier
(b) Other means of identification;
(c) Recommended use of the chemical and
restrictions on use;
(d) Details of principal suppliers (including name,
address, phone number, etc.);
(e) Emergency phone number
2.
Hazard identification
(a) Classification of the substance/mixture and
any nation or regional information;
(b) Label elements (hazard pictogram or symbol,
signal word, hazard statement and precautionary
statements). Hazard symbols may be provided as a
graphical reproduction of the symbols in black and
white or name of the symbols e.g. ‘flame’ , ‘ skull
and crossbones’;
(c) Other hazards which do not result in
classification (e.g. dust explosion hazard) or are not
covered by the Regulations.
3.
Composition and information of the ingredients of
Substance
the hazardous chemical
(a) Chemical identity;
(b) Common name, synonyms, etc;
(c) CAS number and other unique identifiers;
(d) Impurities and stabilizing additives which are
themselves classified and which contribute to the
classification of the substance.
Mixture
The chemical identity and concentration or
concentration ranges of all ingredients which are
hazardous and are present at or above cut-off
value.
4.
First-aid measures
(a) Description of necessary measures,
subdivided according to the different routes of
exposure, i.e. inhalation, skin and eye contact and
ingestion;
(b) Most important symptoms/effects, acute and
delayed;
(c) Indication of immediate medical attention
and special treatment needed, if necessary.
64
5.
Fire-fighting measures
(a) Suitable (and unsuitable) extinguishing
media;
(b) Specific hazards arising from the chemical
(e.g. nature of any combustion hazardous
products);
(c) Special protective equipment and precautions
for fire-fighters
6.
Accidental release measures
(a) Personal precautions, protective equipment
and emergency procedures;
(b) Environmental precautions;
(c) Methods and material for containment and
cleaning.
7.
Handling and storage
(a) Precautions for safe handling;
(b) Conditions for safe storage, including any
incompatibilities.
8.
Exposure controls and personal protection
(a) Control parameters e.g. permissible exposure
limit and biological limit values;
(b) Appropriate engineering controls;
(c) Individual protection measures, such as
personal protective equipment.
9.
Physical and chemical properties
(a) Appearance (physical state, colour, etc.);
(b) Odour;
(c) Odour threshold;
(d) pH;
(e) Melting point/freezing point;
(f) Initial boiling point and boiling range;
(g) Flash point;
(h) Evaporation rate;
(i) Flammability (solid, gas);
(j) Upper/lower flammability or explosive limits;
(k) Vapour pressure;
(l) Vapour density;
(m) Relative density;
(n) Solubility(ies);
(o) Partition coefficient : n-octanol/water;
(p) Auto-ignition temperature;
(q) Decomposition temperature;
(r) Viscosity.
65
10.
Stability and reactivity
(a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous reactions;
(d) Condition to avoid (e.g. static discharge,
shock or vibration);
(e) Incompatible materials;
(f) Hazardous decomposition products.
11.
Toxicological information
Concise but complete and comprehensible
description of the various toxicological (health)
effects and the available data used to identify
those effects, including
(a) Information on the likely routes of exposure
(inhalation, ingestion, skin and eye contact);
(b) Symptoms related to the physical, chemical
and toxicological characteristics;
(c) Delayed and immediate effects and also
chronic affects from short and long term exposure;
(d) Numerical measures of toxicity (such as acute
toxicity estimates).
12.
Ecological information
(a) Ecotoxicity (aquatic and terrestrial, where
available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects.
13.
Disposal information
Description of waste residues and information on
their safe handling and method of disposal,
including the disposal of any contaminated
packaging.
14.
Transportation information
(a) UN number;
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g. marine pollutant
(Yes/No);
(f) Transport in bulk (according to Annex II of
MARPOL 73/78 and the IBC Code);
(g) Special precautions which a user needs to be
aware of, or needs to comply with, in connection
either within or outside their premise.
66
15.
Regulatory information
Safety, health and environmental regulations
specific for the product in question.
16.
Other information
(a) Date of preparation of the SDS;
(b) Date of revision of the SDS;
(c) Key literature references and sources for data
used to compile the SDS;
(d) Key/legend to the abbreviations and
acronyms used in the SDS;
(e) Other information deems necessary by a
supplier.
Appendix 2
Maklumat minimum bagi SDS adalah seperti yang di dalam jadual di bawah;
Seksyen
Tajuk seksyen
Maklumat minimum
1.
Pengenalan bahan kimia
(b) Kaedah pengenalan lain;
dan pembekal
(c) Kegunaan yang disarankan bagi bahan kimia
(a) Pengecam produk;
dan kekangan kegunaan;
(d) Rincian pembekal (termasuk nama, alamat,
nombor telefon dan sebagainya.);
(e) Nombor telefon kecemasan.
(a) Pengelasan bagi bahan/campuran dan apaapa
2.
Pengenalan bahaya
maklumat negara atau serantau;
(b) Unsur label (piktogram bahaya atau simbol,
kata isyarat, pernyataan bahaya dan
pernyataan berjaga-jaga). Simbol bahaya
boleh diberikan sebagai salinan grafik bagi
simbol dalam warna hitam dan putih atau nama
simbol tersebut seperti ‘nyalaan’, ‘tengkorak dan
tulang bersilang’;
(c) Bahaya lain yang tidak termasuk dalam
pengelasan (misalnya, bahaya letupan habuk)
atau tidak diliputi dalam Peraturan ini.
Bahan
3.
Komposisi dan maklumat
(a) Identiti bahan kimia;
mengenai ramuan bahan
(b) Nama biasa, sinonim, dan sebagainya;
kimia berbahaya
(c) Nombor CAS dan pengecam unik lain;
(d) Bendasing dan bahan tambah penstabil yang
telah dikelaskan dan menyumbang kepada
pengelasan bahan.
Campuran
Identiti bahan kimia dan kepekatan atau julat
kepekatan bagi semua ramuan yang berbahaya
dan hadir melebihi aras nilai pemisah bagi
kepekatan.
67
(a) Perihalan langkah yang perlu diambil,
4.
Langkah-langkah
disubbahagikan menurut laluan pendedahan
pertolongan cemas
yang berbeza; iaitu, penyedutan, sentuhan
kulit dan mata, serta pengingesan;
(b) Gejala/kesan akut dan tertangguh yang paling
penting;
(c) Petunjuk bagi keperluan perhatian perubatan
segera dan rawatan khas, jika ada.
(a) Bahan memadamkan api yang sesuai (dan
5.
Langkah-langkah
tidak sesuai);
pemadaman kebakaran
(b) Bahaya khusus daripada bahan kimia
(misalnya ciri produk pembakaran berbahaya);
(c) Kelengkapan pelindung khas dan langkah
berjaga-jaga bagi petugas pemadam
6.
Langkah-langkah pelepasan
(a) Tatacara perlindungan diri, kelengkapan
tidak sengaja
pelindung, dan kecemasan.
(b) Langkah melindungi alam sekitar.
(c) Kaedah dan bahan untuk pembendungan dan
pembersihan.
7.
Pengendalian dan
(a) Langkah berjaga-jaga untuk pengendalian
penyimpanan
selamat.
(b) Keadaan penyimpanan selamat, termasuk
apa-apa ketakserasian.
8.
Kawalan pendedahan dan
(a) Parameter kawalan, misalnya had
perlindungan diri
pendedahan dibenarkan atau nilai had biologi.
(b) Kawalan kejuruteraan yang sesuai.
(c) Langkah perlindungan individu, seperti
kelengkapan perlindungan diri.
(a) Rupa (keadaan fizikal, warnadan sebagainya).
9.
Sifat fizikal dan kimia
(b) Bau.
(c) Ambang bau.
(d) pH.
(e) Takat lebur/takat beku.
(f) Takat didih awal dan julat didih.
(g) Takat kilat.
(h) Kadar penyejatan.
(i) Kemudahbakaran (pepejal, gas).
(j) Had kemudahbakaran atau boleh letup
atas/bawah.
(k) Tekanan wap.
(l) Ketumpatan wap.
(m) Ketumpatan bandingan.
(n) Keterlarutan.
(o) Pekali petakan: n-oktanol/air.
(p) Suhu pengautocucuhan.
(q) Suhu penguraian.
68
(r) Kelikatan.
10. Kestabilan dan kereaktifan
10.
Kestabilan dan kereaktifan
(a) Kereaktifan.
(b) Kestabilan kimia.
(c) Kemungkinan tindak balas berbahaya.
(d) Keadaan yang perlu dielakkan (misalnya,
nyahcas statik, kejutan atau getaran).
(e) Bahan tak serasi.
(f) Produk penguraian berbahaya.
Perihalan yang padat tetapi lengkap dan boleh
11.
Maklumat toksikologi
difahami bagi pelbagai kesan toksikologi
(kesihatan) dan data tersedia yang digunakan
untuk mengenal pasti kesan tersebut, termasuk:
(a) Maklumat tentang laluan pendedahan yang
mungkin (penyedutan, pengingesan, sentuhan
kulit dan mata);
(b) Gejala berkaitan dengan ciri fizikal, kimia, dan
toksikologi.
(c) Kesan tertangguh dan serta-merta dan juga kesan kronik
daripada pendedahan jangka
pendek dan jangka panjang.
(d) Ukuran berangka bagi ketoksikan (seperti
anggaran ketoksikan akut).
(a) Keekotoksikan (akuatik dan daratan, sekiranya
12.
Maklumat ekologi
boleh didapatkan)
(b) Keselanjaran dan keterdegradan.
(c) Potensi bioterkumpul.
(d) Kebolehgerakan di dalam tanah.
(e) Kesan mudarat yang lain.
13.
Maklumat pelupusan
Perihalan baki sisa dan maklumat tentang
pengendalian yang selamat dan kaedah
pelupusan, termasuk pelupusan apa-apa
pembungkusan tercemar.
14.
Maklumat pengangkutan
(a) Nombor UN.
(b) Nama penghantaran sah PBB.
(c) Kelas bahaya pengangkutan.
(d) Kumpulan pembungkusan, jika berkenaan.
(e) Bahaya alam sekitar (contoh: Bahan cemar
marin (Ya/Tidak)).
(f) Pengangkutan secara pukal (menurut
Tambahan II bagi MARPOL 73/78 dan Kod
IBC)
(g) Langkah berjaga-jaga khas yang pengguna
perlu ketahui atau patuhi berhubung dengan
pengangkutan atau penghantaran sama ada di
dalam atau di luar premis mereka.
69
15.
Maklumat pengawalseliaan
Peraturan keselamatan, kesihatan, dan alam
sekitar yang khusus untuk produk yang
berkenaan.
16.
(a) Tarikh penyediaan SDS;
Maklumat lain
(b) Tarikh semakan SDS;
(c) Rujukan utama dan sumber data yang
digunakan untuk menyusun SDS;
(d) Kekunci/petunjuk kepada singkatan dan
akronim yang digunakan dalam SDS;
(e) Apa-apa maklumat yang dirasakan perlu oleh
pembekal.
Appendix 3
Specification of Pesticides - Technical Grade of Active Ingredient (TC/TK)
The specifications of a pesticide shall conform to the either Malaysian Regulations, FAO or WHO
requirements or FAO or WHO specifications wherever such specifications are available and shall
include the following, where appropriate:
1.
Composition of the pesticide (including impurities, by-products, related products, stating their
concentrations)
2.

Minimum content of active ingredient, state in g/kg or % w/w

Maximum content of significant and relevant impurities, state in g/kg or % w/w

Necessary method of analysis
Specific Properties/ Test Related to Use
a) Appearance

physical state, colour, ( for all formulation)
b) Relevant impurities
c) Water content (if applicable) and insoluble (if applicable)
d) Acidity and/or alkalinity or pH range – ( for any material where adverse reaction
would accrued in the presence of excessive acid or alkali)
70
Appendix 4
Specification of Pesticides (Formulated Product)
The specifications of a pesticide shall conform to the either Malaysian Regulations, FAO or WHO
requirements or FAO or WHO specifications wherever such specifications are available and shall
include the following, where appropriate:
1. Composition of the pesticide (including inerts ingredients stating their concentrations)
a.
State in g/kg or g/L or % w/w or %w/v.
b.
Maximum content of relevant impurities, state in g/kg or % w/w
c.
By products of manufacture (if applicable)
d.
Specific properties/Test related to use
e.
Necessary method of analysis.
71
Appendix 5
Physical and Chemical Properties For Formulated Product
i) Appearance

physical state, colour, ( for all formulation)
ii) Corrosiveness
iii) Flammability (if applicable)
iv) Known compatibility with other chemicals (only to be performed when tank mix is
recommended on the label)
v) Oxidation/reduction :chemical incompatibility (only to be performed when tank mix is
recommended on the label)
vi) Rate of release, or release/retention index, of active ingredient ( for slow- release granules
(CG), slow-release capsule suspensions (CS), long lasting insecticidal nets (LN).
vii) “Free” active ingredient (For slow release granules (e.g. encapsulated granules, CG) and
slow release capsule suspensions (CS).
viii)
By- products of manufacture or storage (all specifications where relevant impurities
may be associated with active ingredient
ix) Specific Properties/ Test Related to Use
a. Density Properties
i. Bulk (pour and tap) density (for powders and granulated materials)
ii. Relative density (for all liquid formulations)
b. Surface Properties
i.
Wettability (for all solid formulation to be dispersed or dissolved in water)
ii. Persistent foam (for all formulations intended for dilution with water before
use)
c. Volatilization Properties
i.
Volatility (for Ultra –low volume liquids (UL) )
ii. Flammability
72
d. Particulate, fragmentation properties
i.
Wet sieve test ( applicability for Wettable powders (WP), Suspension
concentrate including those for seed treatment and oil based (SC, FS and OD),
Water dispersible powders foe slurry seed treatment (WS), water dispersible
granules (WG), aqueous capsule suspensions (CS), dispersible concentrates
(DC), suspo-emulsions (SE), water-soluble and dispersible tablets (ST and
WT) and emulsifiable granules and powder (EG and EP)
ii.
Dry sieve test – (for powders and granules intended for direct application)
iii.
Nominal size range – (for granules (GR) formulation)
iv.
Dustiness – (For Granules (GR), water dispersible granules (WG), emulsifiable
granules (EG) and water soluble granules (SG)
v.
Attrition resistance or degree of attrition – (for Granular formulation
(GR,WG,SG and EG) and tablet formulation (DT, WT, ST, depending upon
their intended mode of use)
vi.
Tablet intergrity –( Tablet (DT, ST and WT)
vii.
Adhesion to seeds – ( for all seed treatment)
viii.
Particle size range – (for multiple phase formulation, if appropriate)
e. Dispersion Properties
i.
Dispersibility and spontaneity of dispersion – ( for suspension concentrate
(SC), aqueous capsule suspensions (CS) and water dispersible granules (WG)
ii.
Suspensibility – ( for wettable powder (WP), suspension concentrate (SC),
capsule suspension (CS) and water dispersible granules (WG)
iii.
Dispersion stability – (for suspo-emulsion (SE), emulsifiable granules (EG),
emulsifiable powders (EP), dispersible concentrate concentrates (DC) , oil
based suspension concentrate (OD), mixed formulations of CS and SE (ZC),
mixed formulation of CS and EW (ZW)
iv.
Emulsion stability and re-emulsification – (for emulsifiable concentrates (EC),
emulsions, oil in water (EW) and microemulsion (ME)
73
f.
Flow properties
i.
Flowability – ( for water dispersible granules (WG), water soluble granules
(SG), granules (GR)
ii.
Pourability – (for Suspension concentrates (SC,FS and OD), aqueous capsule
suspension (CS), suspo- emulsions (SE), and similarity viscous formulations,
but may also be applied to formulations in solution, such as soluble concentrate
(SL) and emulsifiable concentrate (EC)
iii.
Viscosity - (for Ultra –low volume liquids (UL) )
g. Solution and dissolution properties
i.
Acidity and/or alkalinity or pH – ( for any material where adverse reaction
would occurred in the presence of excessive acid or alkali)
ii.
Miscibility with hydrocarbon oil – ( for any specification for a formulation
intended to be diluted with oil before use ( e.g. OL)
iii.
Dissolution of water soluble bags – ( for all formulations packaged in water
soluble bags)
iv.
Solution stability – (specification for all water soluble formulations)
h. Others
i.
Burning time (for mosquito coil)
ii.
Breaking load (for mosquito coil)
iii.
Strength of coil (for mosquito coil)
iv.
Separation of ‘twin’ coil (for mosquito coil)
v.
Separation test (for mosquito coil)
vi.
Discharge rate (for aerosol)
vii.
Internal pressure (for aerosol)
viii.
Particle size
ix.
Vaporization rate (liquid vaporizer)
x.
Minimum effective rate (liquid vaporizer)
xi.
Evaporation rate (Vaporizing mats)
2. All test methods must be specified and supported by references.
74
Appendix 6
GARIS PANDUAN PENGHANTARAN PIAWAI ANALISIS UNTUK TUJUAN
PENDAFTARAN RACUN PEROSAK
1. Piawai Racun Perosak
1.1
Bekas Piawai
 Botol kaca.
 Saiz botol : diameter atas (mulut) : ~ 1.5cm, tinggi ~ 4.0cm.
 Warna botol : amber atau gelap.
 Penutup botol : jenis yang mudah buka dan tutup.
1.2
Maklumat pada label bekas piawai (sekurang-kurangnya);
 Nama kimia atau nama biasa (nama ISO atau nama yang disahkan).
 Nombor lot atau batch.
 Berat.
 Ketulinan (purity).
 Tarikh luput.
 Label dilekat pada bekas yang mengandungi piawai.
1.3
Berat 100mg, 250mg atau 1g.
(berat yang kurang daripada 100mg tidak diterima).
1.4
Ketulinan minima yang boleh diterima iailah 95%
(Pengecualian adalah diberi kepada piawai analisis dari kumpulan natural
products seperti pyrethrins, CMIT, MIT, BIT, Azadiracthin, Karanjin dsb.).
1.5
Tarikh luput minima satu tahun.
2. Sijil Analisis Piawai (COA)
2.1
Maklumat yang terdapat pada beaks piawai mestilah juga terdapat dan sepadan dengan COA.
2.2
COA adalah yang asal dengan tandatangan pegawai bertanggungjawab (chemist or
authorized signatory) atau salinan yang diakui sah oleh pegawai yang diberi kuasa dengan
nama dan jawatan.
2.3
Maklumat pada COA sekurang-kurangnya;
 Nama kimia atau nama biasa (nama ISO atau nama yang disahkan)
 Nombor lot atau batch
 Ketulinan (purity)
 Tarikh luput
 Pernyataan measurement of uncertainty (m.u) atau tolerance limit.
(Pernyataan ini boleh disertakan sebagai lampiran).
 Cara penyimpanan (suhu penyimpanan).
75
GP 2/93
GUIDELINES ON
TOXICOLOGICAL DATA REQUIREMENTS
FOR
PESTICIDE REGISTRATION
Pesticides Board
Malaysia
2009
76
Toxicological Data Requirement for
Pesticide Registration
__________________________________________________
1.
Introduction
1.1. Toxicological data are submitted for pesticide registration is aimed at defining
possible hazards to man, non-target organisms and the environment.
1.2. Many practical recommendations can be derived from appropriate and through
toxicological data such as hazard classification, restrictions on use, appropriate
precautionary measures necessary to allow safe use, suggestion of appropriate
diagnosis and management of a poisoned person, establishment of Acceptable Daily
Intake (ADI) etc.
2.
General Requirements
2.1. For the purpose of these guidelines pesticides are divided into two classes i.e.
commodity and proprietary pesticides.
2.2.
Commodity pesticides
2.2.1. For commodity pesticides, acute oral and acute dermal toxicity studies
done on rats are required to be submitted. The detailed requirements
are given in Appendix 1.
2.2.2. Full reports of the above studies must be made available at registration.
2.3.
Proprietary pesticides
2.3.1 For proprietary pesticides, toxicological studies required to be submitted
are dependent on the general use pattern and type of pesticide in
question i.e. whether it is a conventional chemical or a microbial
pesticide. The detailed toxicological requirements needed for chemical
and microbial pesticides are given Table A and Table B of Appendix 1
respectively.
2.3.2 Full reports of the above studies must be made available at registration.
2.4. Letter of consent authorizing the applicant to use the data for registration
purposes must be provided if another company’s data is submitted.
77
3.
Acceptable protocol
3.1.
All toxicological studies should be carried out based on internationally
accepted protocols. Toxicological study protocols such as those
produced by The Environmental Protection Agency of United States
(USEPA), Organization for Economic Cooperation and Development
(OECD), the Ministry of Agriculture, Forestry and Fisheries of Japan may
be used.
3.2.
As examples of acceptable protocols, the Pesticides Board has also
come out with minimum requirements for each test protocol as outlined
in Appendix 2 and Appendix 3 which can also be referred.
3.3.
Protocols for acute oral and acute dermal studies are given in more
detail as in Table C and Table D of Appendix 3. This is in order to
provide applicants who wish to generate data locally with complete
guidelines and reporting format.
3.4.
In conducting the toxicological studies, the applicants are required to
rigidly comply with Good Laboratory Practice standards.
4. Exemptions
4.1
The following are pesticides which can be registered without the
submission of toxicological data.
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
boric acid
borax
copper oxychloride
copper sulphate
cupric sulphate pentahydrate
cuprous oxide
cupric hydroxide
sodium dichromate
sulphur
sodium chlorate
phosphorous acid
78
Appendix 1 (Page 1)
TABLE A : TOXICOLOGICAL DATA REQUIREMENTS FOR REGISTRATION OF
CHEMICAL PESTICIDES
Data Required
General Use Pattern
Non
Food Food InOut Fores
Crop Crop door Door
try
Remarks
ACUTE TESTING
Acute oral
Acute dermal
Acute inhalation
Eye irritation
Skin irritation
Dermal sensitization
Acute delayed neurotoxicity
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
R
R
R
R
R
R
R
R
(1)
(1), (2)
(3)
R
R
R
R
R
R
R
R
R
CR
CR
CR
CR
CR
CR
(6)
(7)
R
R
R
R
R
R
R
R
CR
CR
R
CR
CR
CR
R
CR
CR
CR
R
CR
(8)
(9)
R
R
CR
R
R
CR
R
CR
R
CR
CR
R
CR
R
CR
CR
CR
CR
CR
CR
CR
R
CR
R
CR
CR
R
CR
R
CR
(13)
(13)
(14)
(14)
(15)
(16)
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
(1)
(4)
SUBACUTE TESTING
90 days feeding study
CHRONIC TESTING
Chronic feeding study
Carcinogenicity study
SPECIAL STUDIES
Teratogenicity
Reproduction
Mutagenicity
Metabolic
Wildlife Hazards
Fish acute toxicity
Other tests on fish
Avian acute oral toxicity
Other tests on avian
Honey bee acute toxicity
Effects on other wildlife
(10)
Human Toxicological Data
Industrial exposure data
Accidental data
Suicidal data
Volunteers data
Poisoning symptoms
Antidote statements
Protective clothing
KEY: R = Required; CR = Conditionally Required;
(11)
(11)
(11)
(11)
(12)
79
Appendix 1 (Page 2)
TABLE B : TOXICOLOGICAL DATA REQUIREMENTS FOR REGISTRATION
OF MICROBIAL PESTICIDES
Data Required
General Use Pattern
Non
Food Food InOut Fores
Crop Crop door Door
try
Remarks
ACUTE TESTING
Acute oral/ pathogenicity
Acute dermal
Acute inhalation
Eye irritation/ infectivity
Skin irritation
Hypersensitivity study
SUBACUTE TESTING
Sub-acute/ pathogenicity
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
R
R
R
CR
CR
CR
CR
CR
(5)
CR
CR
-
-
-
-
(5)
(5)
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(3)
CHRONIC TESTING
Chronic feeding study
Carcinogenicity study
SPECIAL STUDIES
Teratogenicity
Mutagenicity
Wildlife Hazards
Fish acute toxicity
Other tests on fish
Avian acute oral toxicity
Other tests on avian
Honey bee acute toxicity
Effects on other wildlife
R
CR
CR
CR
CR
CR
R
CR
R
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
CR
CR
CR
CR
R
R
CR
Human Toxicologycal
Data
Industrial exposure data
Accidental data
Suicidal data
Volunteers data
Poisoning symptoms
Antidote statements
Protective clothing
KEY: R = Required; CR = Conditionally Required; (-)= Normally Not required
(11)
(11)
(11)
(11)
(12)
80
Appendix 1 (Page 3)
Remarks:
1.
Not required if test material is a gas or is highly volatile.
2.
Not required if test material is corrosive to skin or has pH less than 2 or more
than 11.5.
3.
Required for commodity pesticides if the product consists of, or under condition
of use will result in an inhalable material.
4.
Required if test material is an organophosphate pesticide.
5.
Required if significant signs of infectivity and advers effects are seen in acute
study or unusual persistence of the microbs.
6.
Required if sub-acute study indicates significant toxic effects.
7.
Required if result of mutagenicity study is positive.
8.
Required if exposure to females is significant.
9.
Required if the use of the product is likely to result in human exposure over a
portion of the human lifespan which is significant in terms of frequency of
exposure, magnitude of exposure or duration of exposure (for example;
pesticides for use in treated fabric for wearing, constant release pesticides
used indoor in aerosol form).
10.
Required if, chronic study and carcinogenicity study are required.
11.
Required if, such data are available.
12.
Required if special safety protective clothing are required to be worn when
handling the product.
13.
Required if the product is intended to be applied directly to water or expected to
transported to water from the use site and significant exposure to aquatic
organisms is anticipated.
14.
Required if significant exposure to bird is expected.
15.
Required if significant exposure to honey bees is expected.
16.
Required if significant exposure to other wildlife is expected.
GENERAL USE PATTERNS
Food crops
1.
Agricultural crops for human consumption
2.
Veterinary
Nonfood crops
1.
Crop for smoking and chewing
2.
Medicinal crops
3.
Ornamental plants
4.
Lawn and turf grasses
5.
General soil treatments
6.
Recreational areas
7.
Roads, tracks and paved areas
8.
Antifoulding treatments
9.
Public health
81
Appendix 1 (Page 4)
Indoor
1.
Houseplants pesticides
2.
Household insecticides
3.
Rodenticides for household use
4.
Pet animals pesticides
5.
Commercial and industrial uses
- Eating establishment
- Transportation facilities
- Buildings and structures
6.
Terminate control inside buildings
Forestry
1.
Forest trees including dead trees, logs and stumps
2.
Forest tree nurseries
3.
Non-ornamental trees including rubber trees
Outdoor
1.
Domestic ornamental platings
2.
Termite control outside buildings
3.
Wood treatments
82
Appendix 2 (page 1)
GUIDELINES FOR TOXICITY STUDIES
Test substance for tests
Unless otherwise specified, the technical grade of the active ingredient shall be tested.
For mixtures of more than one active ingredient, the technical grade of each ingredient
shall be tested. Tests on the actual end-use product will also be acceptable.
1.
ACUTE INHALATION TOXICITY STUDY
1.1.
Purpose
The purpose of this study is to provide information on health hazards likely to
arise from short-term exposure to a pesticide via the inhalation route.
1.2.
Test animals
The rat shall be used. The age, sex and numbers are as stipulated in the acute
oral toxicity study.
1.3.
Dose levels and selection
Al least 3 dose levels shall be used and spaced appropriately to produce test
group with a range of toxic effects and mortality rates.The data should be
sufficient to produce a dose-response curve and permit an acceptable
determination of the LC50 value.
1.4.
Exposure conditions
Using inhalation equipment, animals should be exposed for at least 4 hours to
the test substance in graduated concentrations, allowing sufficient time for
chamber equilibrium. Description of the outline of the inhalation equipment and
its operation should be included in the test report.
1.5.
Observation period
This should be at least 14 days. Clinical observations should be carried out at
least once daily.
1.6.
Pathology
Same as stipulated in the acute oral toxicity study.
2.
2.1.
PRIMARY EYE IRRITATION STUDY
Purpose
The purpose of this study is to obtain information on whether a hazard or
hazard are likely to arise from exposure of the eyes to the test substance.
83
Appendix 2 (page 2)
2.2.
Test substance
Strongly acidic (pH 2 or less) and strongly alkaline (pH 11.5 or more) substance need
not be tested.
2.3.
Test animals
At least 6 young adult albino rabbits shall be used.
2.4.
Test procedure
For testing liquids, a dose of 0.1 ml should be used. For solids and pastes, the amount
used should have a volume of 0.1 ml or weight of 0.1 g. Solid or granular substances
should be ground to a fine dust first. The test substance should be placed in the
conjunctival sac of one eye and the lids then held together for about one second. The
other eye remains as a control.
The eyes of the test animal should not be washed out for 24 hours following
application of the dose.
2.5.
Clinical examination and scoring
The eyes should be examined at 1, 24, 48 and 72 hours. The grades of ocular reaction
should be recorded. If no evidence of irritation is seen, the study is terminated.
Extended observation may be necessary if there is persistent corneal involvement or
other ocular irritation, for up to 21 days.
3.
DERMAL SENSITISATION STUDY
3.1.
Purpose
The study is used to identify the possible hazard to a population repeatedly exposed to
the test substance.
3.2.
Test substance
The end-use product should be used. Strongly acidic or alkaline substances (pH 2 or
less, or pH 11.5 or greater) might not be tested.
3.3.
Test animals
The young adult guinea pig is the preferred species. The number used depends on the
method employed.
3.4.
Test methods
Any of the following seven test methods would be acceptable. Use of a positive control
substance to test for reliability of the test system is recommended.
84
Appendix 2 (page 3)
Draize Test
Freund’s Complete Adjuvant Test
Mauer Optimisation Test
Buehler Test
Open Epicutaneous Test
Guinea Pig Maximisation Test
Split Adjuvant Technique
4.
ACUTE DELAYED NEUROTOXICITY STUDY
4.1.
Purpose
This screening procedure is for detecting delayed neurotoxic potential of the
test substance.
4.2.
Test animals
The adult domestic laying hen is recommended in sufficient numbers such that
at least six survice the observation period.
4.3.
Dose levels and selection
A preliminary LD50 test should be performed in unprotected hens to establish
the dose levels to be used in this test. The selected dose level should not be
less than the unprotected dose. Doses of test substance higher than 5,000
mg/kg need not be tested.
4.4.
Controls
In addition to an untreated control group, a positive control group should be
used consisting of at least 4 hens treated with a known delayed neurotoxicant,
such as TOCP.
4.5.
Administration of dose
The test substance is preferably administered orally in a single dose by gavage
or using gelatine capsules. After a short while, a protective agent e.g. atropine
should be administered, to prevent death due to cholinergic effects.
85
Appendix 2 (page 4)
4.6.
Observation of animals
All hens should be observed at least once daily up to 21 days after
administration. Signs of toxicity including the time onset should be recorded.
The hens should be subjected to a period of forced motor activity at least twice
a week to enhance the observation of minimal responses. If neurotoxic
responses are not observed or if equivocal responses are seen, then the dose
should be repeated and observations made for another 21 days.
4.7.
Pathology
The examination should be performed on specific nerve tissues such as brain,
spinal cord, terminal peripheral nerves. Sections of the proximal region of the
tibial nerve and its branches should also be taken for examination. Staining of
nervous tissue sections should be made with appropriate myelin or axonspecific stain as well as hematoxylin-eosin stain.
5.
5.1.
SUBCHRONIC ORAL TOXICITY (90-DAY) STUDY
Purpose
This study permits the determination of the no-observed effect level and toxic
effects associated with continous or repeated exposure to a substance for a
period of 90 days. It also provides information on possible health hazards likely
to arise from repeated exposures over a limited period of time.
5.2.
Test animals
At least to mammalian species should be used. The rat and dog are preffered.
Young, healthy animals (at least 10 of each sex) should be used for the rodent
species while 8 (4 of each sex) should be used for the non-rodent species, at
each dose level. If interim sacrifices are planned, the number should be
increased appropriately.
5.3.
Administration
The test substance may be administered in the diet or in capsules. For rodents,
it may be administered by gavage or in the drinking water.
5.4.
Dose levels and selection
At least 3 dose levels and additional control group should be used. This can be
either an untreated group or a vehicle control group. If the toxic properties of
the vehicle is not known, then both untreated and vehicle control groups are
required. The highest dose level in rodents should result in toxic effects but not
produce an incidence of fatalities which would prevent a meaningful evaluation.
For non-rodents, there should be no fatalities.
A satellite group may be treated with the high dose level for 90 days and
observed a further 28 days for reversibility, persistence or delayed occurrence
of toxic effects.
86
Appendix 2 (page 5)
5.5.
Exposure period
The test substance should be administered to the animals, for a period of 90
days. For practical considerations, dosing on a 5-days-per-week basis is
acceptable.
5.6.
Observation of animals
Cageside and clinical examinations are required, the former at least once each
day. Clinical examinations should include:
5.6.1. Hematology determinations i.e. hematocrit, hemoglobin concentration,
erythrocyte count, total and differential leukocyte count and a measure
of clotting potential (e.g. clotting time, prothrombin time etc.) These
determinations should be made at the end of the test period for all
survivors. For non-rodents, they should be made at the beginning and
once or twice through the test period as well as at the termination.
5.6.2. Clinical biochemistry determinations on blood e.g. calcium, phosphorus,
sodium, fasting glucose, SGPT, SGOT, urea nitrogen, albumen, blood
creatinine etc. These determinations should be carried out on all
survivors at the end of the test period. For non-rodents, these
examinations should be done once or twice thoughts, these
examinations should be done once or twice through the test period as
well as at the termination.
5.6.3. Urinalysis – only on hight dose and control animals, at the end of the test
period. Tests on appearance, protein, glucose, ketone, occult blood
contents and also microscopy of sediments should be carried out.
5.6.4. Opthalmological examination – only on high dose and control groups, to
be made prior to administration of the test substance and at termination
of study.
5.7.
Pathology
Gross necropsy is required on all animals including those which died or were
found in moribund condition and sacrificed. The major organs should be
weighed i.e. liver, kidneys, adrenals and testes. For non-rodents the thyroid
and parathyroid should also be weighed.
5.8.
Tissue preservation
All gross lesions and certain tissues such as the brain, thyroid, lungs, heart,
bone marrow, liver, salivary glands, kidney, spleen, intestines etc. or their
representative samples should be preserved in a suitable medium.
87
Appendix 2 (page 6)
5.9.
Histopathological examination
Full histopathology should be performed on the organs and tissues mentioned
above, of all rodents in the control and high dose groups, all non-rodents and
all rodents that died or were killed during the study. The examinations should
include all gross lesions and target organs.
In addition certain organs (liver, lungs and kidneys) should also be examined in
the low and intermediate dose groups.
6.
CHRONIC TOXICITY STUDY
6.1.
Purpose
The study is meant to determine the effects of a substance in a mammalian
species following prolonged and repeated exposure. Under the conditions of
this test, effects which require a long latent period or are cumulative should
become manifest.
6.2.
Test animals
Equal numbers of both sexes of at least two mammalian species, a rodent and
non-rodent, should be used, whose characteristics are well-known e.g. rat and
dog. Dosing of rats should begin as soon as possible after weaning, and of
dogs when they are between 4 and 6 months of age.
For rodents it is preferable to perform interim sacrifice, therefore the total
number of animals should be increased appropriately.
6.3.
Administration of dose
Generally, the animals should receive the test substance in their diet.
6.4.
Dose levels and selection
At least three dose levels should be used together with a control group. When
the test substance is administered mixed in a vehicle other than food, and the
toxic properties of the said vehicle is unknown, both untreated and vehicle
control groups are required.
6.5.
Exposure period
The duration of the exposure period should be 24 months for rats, 18 months
for mouse and 12 months for dogs.
88
Appendix 2 (page 7)
6.6.
Observation of animals
Careful clinical examination should be made at least each week. Records
should be kept of the body weights, food week. Records should be kept of the
body weights, food consumption, sign of toxicity including onset and death; also
time of death.
6.7.
Clinical pathology
If possible, the same animals should be used in the interim examinations.
These include hematology, clinical biochemistry, urinalysis and opthalmological
examinations. At least 10 rodents/sex/dose should be used, and all animals in
the non-rodent group. The examinations should be done at least every 6
months and at study termination.
6.8.
Pathology
Complete gross necropsy should be done on all animals, including those which
died during the experiment or were killed in moribund condition. Specific organs
and tissues should be preserved for possible future histopathological
examination. These include all gross lesions, brain, heart, spleen, uterus,
kidneys, adrenals, muscles, spinal cord, lymph nodes, eyes etc.
6.9.
Histophathological examination
This should be done for all non-rodents. For rodents, all animals in the control,
highest dose group and all those which died or were killed during the study
should be examined. All gross lesions, target organs, lungs, liver and kidneys
should be examined. Examination of organs in the other test group depend on
the organs showing effects in the highest dose group.
7.
7.1.
ONCOGENICITY STUDY
Purpose
In this long-term carcinogenicity study, the purpose is to observe test animals
for a major portion of their life span for the development of neoplastic lesions
during or after exposure to various doses of a test substance by an approptriate
route of administration.
This study may be combined with the chronic toxicity study, if appropriate.
7.2.
Test animals
Equal numbers of both sexes of two mammalian species, preferably rat and
mouse, should be used. Strains that have sufficient historical background data
on spontaneous tumours are preferred. For rodents, at spontaneous tumours
are preferred. For rodents, at least 50 males and 50 females should be used at
each dose level including control. If interim sacrifice is planned, the number
should increase appropriately.
89
Appendix 2 (page 8)
7.3.
Administration of dose
In principle, the animals should be given the test substance in their diet.
7.4.
Dose levels and selection
At least three dose levels should be used with a control. This can be either an
untreated group or a vehicle control group. If the toxic properties of the vehicle
is not known, then both untreated and vehicle control group are required.
7.5.
Exposure period
This should comprise the majority of the normal life span of the strain of
animals to be used, e.g. not less than 24 months for rats and 18 months for
mice.
7.6.
Observation of animals
Careful clinical observation should be made at least twice each week, where
special attention should be paid to tumour development. Other observations
include body weight and food consumption.
7.7.
Haematology determinations
Blood smears and differential blood count should be obtained from all surviving
animals of the high dose and control groups at 12 and 18 months and also
terminal sacrifice. If relevant, the same samples should be taken from the other
groups.
7.8.
Pathology
Gross necropsy and tissue preservation (as per chronic toxicity study) should
be carried out. In addition, visible tumours and lesions suspected to be
tumorous should be preserved. This also holds for histopathology, where the
examinations to be done are also the same as for the chronic toxicity study.
8.
REPRODUCTION STUDY
8.1.
Purpose
This study is meant to provide general information concerning the effects of the
test substance on reproductive function including estrus cycles, mating
behaviour, conception, parturition, lactation, weaning and growth and
development of offspring. It may also provide information about the effects of
the test substance on neonatal morbidity, mortality and may generate
preliminary data on teratogenesis.
90
Appendix 2 (page 9)
8.2.
Number of generations
Generally, two generations should be treated and observed. For F 1, and F2
generations, testing should be performed in the first offspring (first litter) and
the second offspring only where necessary.
8.3.
Test animals
The rat or mouse are the preferred species.
Administration of test substance to parental (P) animals should begin
immediately after weaning. Each test and the control group should contain at
least 20 males and sufficient number of non-pregnant females to yield at least
20 pregnant females at parturition.
8.4.
Dose levels and dose selection
At least three dose levels and a control is required where the highest dose level
should induce toxicity but not mortality in dams. If a vehicle is used in
administering the test substance, the control group should receive the vehicle
in the highest volume used.
8.5.
Experimental schedule
The diagram presented below indicates the experimental schedule for dosing,
mating, parturition and sacrifice.
91
Appendix 2 (page 10)
Experimental Schedule for Test Substance Administration and
Animal Reproduction
Weeks on
Study
P
F1
0
Dosing begins
8-14
11-17
F1 mating
period
F1 born and
litter size
adjusted to 8
pups each.
14-20
Dosing of P
animals ends.
P animals are
sacrificed.
F1 weaned; dosing
or F1 males and
females for
mating begins.
22-34
F1 Offspring not
selected for mating
are sacrificed.
25-37
F1 mating.
F2
F2 born and
litter size
adjusted to
8 pups each
F2 weaned and
F1 (selected for
mating)
are sacrificed.
-----------------------------------------------------------------------------------------------------------(1)
For P generation the males and females should be dosed immediately after
weaning and acclimatizing for at least 1 week. The dosing should be continued
for at least 8 weeks prior to the mating period.
(2)
Dosing of the P generation should continue through the mating period,
pregnancy, lactation and weaning of F1 offspring. P animals should be
sacrificed after weaning of the F2 offspring.
(3)
Dosing of F1 animals saved for mating should begin at the time they are
weaned and continue to the weaning of the F2 offspring. F1 and F2 animals
should be sacrificed after F2 offspring are weaned. (Dosing of F2 animals may
be extended if necessary)
92
Appendix 2 (page 11)
8.6.
Administration of dose
In principle, the test substance should be administered in the diet. During
pregnancy the dosage may be based on the body weight at Day 0 and 6 of
pregnancy.
8.7.
Mating procedure
For mating the F1 offspring, 1-2 males and 1-2 females are randomly selected
from as many litters as possible to produce the F2 generation. For cross mating
of the F1 offspring, males and females from the same dose group should be
mated avoiding mating of siblings. F1 offspring not selected for mating should
be sacrificed upon weaning.
Each female should be placed with a single male from the same dose group
until mating is confirmed or 3 weeks have passed. Each morning the female
should be examined for vaginal plug, and Day 0 of pregnancy is defined as the
day vaginal plugs or sperm are found. Pairs which fail to mate should be
evaluated to determine the cause of the apparent infertility.
Near parturition, pregnant females should be caged separately in delivery or
maternity cages and provided with nesting materials.
8.8.
Standardization of litter sizes
On Day 4 after birth, the size of each litter should be adjusted by eliminating
extra pups by random selection to yield 4 males and 4 females per litter. If this
is not possible, partial adjustment to 8 animals in total is permitted. However,
adjustments are not appropriate for litters of less than 8 pups.
8.9.
Observation of animals
Each animal should be observed at least once daily and pertinent behaviuoral
changes or signs of toxicity recorded. The duration of gestation should be
calculated from day 0 of pregnancy. Each litter should be examined as soon as
possible after delivery for the number of pups, stillbirth, live births and presence
of gross anomalies. From the results of all observations, mating indices,
parturition indices, number of males, impregnated females and viability indices
of weanlings should be calculated.
93
Appendix 2 (page 12)
The definitions of these parameters are:
Mating index
=
No. of animals mated x 100
-------------------------------------------------No. of animals used for mating
Pregnancy index
=
No. of pregnant females x 100
-------------------------------------------------No. of males mated
Parturition index
=
No. of females delivering live pups x 100
------------------------------------------------------No. of pregnant females
Viability index at weaning = No. of viable pups at weaning x 100
-------------------------------------------------Adjusted no. of pups at day 4 of birth
8.10. Gross necropsy
When sacrificed, each animal should be examined macroscopically with special
attention to the organs of reproduction, and these organs should be preserved
for histopathological examination.
8.11. Histopathology
Histopathology of the following organs and tissues of all highest dose and
control P and F1 animals selected for mating should be performed : vagina,
uterus, ovaries, testes, epididymus, seminal vesicles, prostrate and pituitary.
Organs demonstrating toxicologically significant abnormalities should then be
examined histopathologically in animals from the other dose groups.
9.
TERATOGENICITY STUDY
9.1.
Purpose
The study us aimed at obtaining information on whether the test substance has
the potential to induce permanent structural or functional abnormalities during
the period of embryonic development.
94
Appendix 2 (page 13)
9.2.
Test animals
At least twenty pregnant animals of a suitable species (rat, mice or hamster) or
twelve rabbits should be used at each dose level and control group. The strain
used should be characterized for its response to teratogens.
9.3.
Dose levels and selection
At least three dose levels with a control should be used. In the case of
substance of low toxicity, if a dose level of at least 1000 mg/kg produces no
evidence of embryotoxicity or teratogenicity, studies at other dose levels are
not necessary.
If a vehicle is used, it should not be teratogenic nor have effects on
reproduction. There should then be a vehicle control group.
9.4.
Exposure period
Day 0 of pregnancy is the day on which vaginal plug and/ or sperm is observed.
The dose period should cover the period of major organogenesis, and may be
extended to approximately 1 day before the expected delivery date.
9.5.
Administration
The test substance should be administered orally by gavage at approximately
the same time each day. Allowance must be made for the rapid weight gain
which takes place during pregnancy when deciding the amount to be
administered.
9.6.
Observation of animals
The animals should be observed at least once each day and records made of
all observations including signs of toxicity, time of onset, degree, duration; also
food consumption and body weight. Females showing signs of abortion of
premature delivery should be sacrificed and subjected to thorough macroscopic
examination.
9.7.
Teratological examination
At the time of sacrifice or death during the study, the dam should be examined
macroscopically for any structural abnormalities or pathological changes which
may have influenced the pregnancy. Immediately after sacrifice or death, the
uterus should be removed and the contents examined for embryonic or fetal
death in utero where this has occurred. The number of corpora lutea should be
determined, the sex of the fetuses also determined and each litter should be
weighed. The mean fetal weight should be derived.
95
Appendix 2 (page 14)
Following removal each fetus should be examined externally for rats, mice and
hamsters, one third to one-half of each litter should be prepared and examined
for skeletal anomalies, and the remaining part of each litter should be prepared
and examined for soft tissue anomalies. For rabbits, each fetus should be
examined by careful dissection for visceral anomalies and then examined for
skeletal anomalies.
10
MUTAGENICITY STUDY
10.1. Purpose
The study is used to determine the ability of the test substance to affect the
integrity of the mammalian cell’s genetic components.
10.2. Basic approach
The battery of studies including the following 3 categories are required:
10.2.1.
Studies to detect gene mutation:
Bacterial Reverse Mutation Assay
Principle of the method: Bacteria are exposed to the test substance both in
the presence and absence of metabolic activation system and plated on
minimal agar medium. After a suitable period of incubation, revertant colonies
are counted and compared to the number of spontaneous revertants in a
solvent control culture. The metabolic activation system stated here is the
method using the mixture (S-9 MIX) of supernatant fraction of the livers of the
animals pre-treated with the agent to induce microsome metabolic enzyme
activity.
Tester strains : Salmonella typhimurium TA100, TA198, TA1535, TA1537 and
other strains, and Escherichia coli WP2 uvr A.
Dose levels : At least 5 dose levels should be used, with the highest level
producing cytotoxic effects. A solvent control, positive control which require S-9
and positive controls which do not require S-9 mix should be used for each unit
of assay.
Number of plates : At least two plates for each dose and control. All plates
should be incubated at 370C for 48-75 hours. At the end of the incubation
period, the number of revertant colonies per plate should be counted.
96
Appendix 2 (page 15)
10.2.2.
Studies to detect chromosomal aberration:
Chromosomal aberration – in vitro Mammalian Cytogenetics Test
Principle of the method : Following exposure to the test substance at various
intervals of the cell cycle, cell cultures of established cell lines or primary cell cultures
are treated with colchicines or colcemide and analysed for chromosomal abnormalities
in metaphase cells.
Main requirements : Cell lines which can be used include human cells, Chinese
hamster cells and human lymphocytes. At least 3 dose levels should be employed, the
highest level producing 50% inhibition of growth. A compound known to produce
chromosomal aberration in vitro should be used as the positive control. A solvent and
untreated control should also be included.
A test with metabolic activation system should also be conducted where a compound
known to require activation should be used as the positive control in this case.
Number of cultures : At least 2 cultures should be used for each experimental point.
For established cell lines, cultures should be treated with the test substance when
they are in the exponential stage of growth. Cell cultures are treated with colchicine
prior to harvesting. Each culture is harvested and processed separately for the
preparation of chromosomes. At least 100 well-spread metaphase cells per culture
should be analysed for chromosomal abnormalities.
10.2.3.
Studies to detect genotoxic effects.
Genotoxic effect – Bacterial Repair Test
Principle of the test method : A paper disc containing the test substance is placed
on an agar plate in which bacterial spores are inoculated. The diameter of inhibition
zone is determined 24 hours after treatment. Tests with metabolic activation are also
recommended.
Tester strains : Bacillus subtilis M45 and H 17 can be used.
Other basic requirements : At least 5 dose levels should be tested, the highest level
producing cytotoxic effects. Negative controls such as kanamycin, streptomycin etc.
and positive controls such as AF-2, 2-aminoanthracene etc. should be employed for
each unit of assay. At least one plate should be used for each dose and control level.
97
Appendix 2 (page 16)
11.
METABOLIC STUDY
11.1. Purpose
The study is aimed at characterizing the behaviour of the test substance in the
animal body such that this cab be used to evaluate test results from other
toxicology studies and also to extrapolate data of test done on animals to man.
11.2. Test substance
Radiochemically pure grade of the active ingredient in labelled form should be
used.
11.3. Test animals
At least 1 species among rat, dog etc. should be used i.e. young adults. It is
preferable to use the same animal species and strain as those being used for
other toxicological studies.
11.4. Dose level and selection
At least 2 dose levels should be used, the upper dose producing toxic or
pharmacologic signs and the low dose corresponding to a no-effect level.
Where feasible, an additional level approximate to the potential dietary
exposure should also be included.
11.5. Administration
The test substance should be administered in the diet but intravenous means
can also be employed if necessary. Animals should receive a single dose but if
the substance is expected to accumulate in the animal, continous dosing
should be done.
11.6. Procedures
The absorption rate and the rate, ratio and route of elimination should be
determined. Periodical measurement of the test substance concentration in
blood, plasma or serum is required for this. Samples of expired air, urine and
feces should be collected separately from each individual animal in order to
determine the excretion. These measurements should be done several times
and continued until approximately 90% of the administered dose is eliminated,
or for 7 consecutive days.
The distribution of the test substance and other related compounds in major
organs should be determined at different time points. The major metabolites
should be identified, to clarify the major metabolic pathways. The recovery of
the dose in the excreted parent substance and its major metabolites should be
determined at a certain period of time after administration.
98
Appendix 2 (page 17)
12.
METABOLISM IN PLANTS
The purpose of this study is to characterize the absorption / translocation of the
test substance via root and foliage system of the plant and the major metabolic
pathways including photochemical reactions of the test substance in the plant
body. Comparison of the plant metabolites with the animal metabolites can be
made combined with the findings from the animal study.
Test plants should preferably be of the crops to be treated with the chemical or
those which are close species to the crops.
Test plants should be treated by a method similar to that of the test chemical.
There are two preferred method-direct application and methods which allow the
plant to absorb the test substance via the root. Absorption, distribution (to
edible part) and metabolism should be determined. Recovery of parent
substance and metabolites in treated and untreated parts should be periodically
determined.
Additional studies include metabolism in the soil and degradation in natural
water, especially if the test substance demonstrates long-term residues in the
soil.
13.
ACUTE FISH TOXICITY STUDY
13.1. Test fish
One or more species may be used, preferably those which are readily available
throughout the year, easily maintained and whose relevant economic, biological
and ecological characteristics are known. They should be acclimatised at least
12 days before the test at temperatures appropriate to the species. Feeding
must be stopped 24 hours before test. All fish must be exposed to water of the
quality to be used in the test for at least 7 days before they are used.
13.2. Preparation of test substance
Stock solutions of the required strength are prepared by dissolving the
appropriate amount of the test substance in the required volume of dilution
water. The chosen test concentrations are prepared by dilution of the stock
solution. The test should be carried out without adjustment of pH. Generally, no
reference substances are required.
99
Appendix 2 (page 18)
13.3. Test procedure
The usual procedure is that of the static test where there is no flow of test
solution occurring – solutions may remain unchanged throughout the duration
of the test. Measurements of pH, dissolved oxygen and temperature must be
carried out at least daily.
The fish are exposed to the test substance at a range of concentrations,
preferably for a period of 96 hours. Mortalities are recorded at 24, 48, 72, and
96 hours and the concentrations which kill 50% of the fish (LC 50) are
determined where possible. Visible abnormalities e.g. loss of equilibrium,
swimming behaviour etc. should be recorded. The maximum concentration
tested producing no mortality and the minimum concentration tested producing
total mortality should be recorded.
Mortality in the controls should not exceed 10% at the end of the test.
Median lethal concentrations can be calculated using internationally-accepted
standard procedures.
100
Appendix 3 (page 1)
TABLE C: PROTOCOL FOR ACUTE ORAL TOXICITY STUDIES
TEST CONDITIONS
ACUTE ORAL
1. Test substance……… i) If the study using the formulation as the test substance
involves any difficulty, technical material may be used
in lieu of the formulation.
ii) If technical grade of active ingredient is used as the test
substance, it should be of the same composition as that
used for manufacturing the formulation.
2. Test animals…………
2.1. Species…………
2.2. Age……………..
2.3. Sex……………
2.4. Number…………
2.5. Animal status
At least one species of rat
Young adult animals should be used
Both sexes and the female should be non-pregnant
For rodents, 10 animals (5 females + 5 males) for each
dose level
Animals should be fasted prior to the substance
administration: Rat – overnight; other animals with higher
metabolic rates a shorter period fasting is sufficient
i) At least 3 dose levels spaced appropriately to produce in
test group a range of toxic effects and mortality rates.
3. Dose levels…………...
The data should be sufficient to produce a dose
response curve and where possible permit an
acceptable determination of LD50.
ii) If a test at one dose level of at least 5000mg/kg body
weight on not less than 10 rats of equal numbers of
sexes using the procedure described for the study,
produces no compound related mortality, then the full
study using the minimum three dose levels might not be
necessary.
4. Preparation of test
substance…………….
When necessary the test substance should be dissolved
or suspended in water or a suitable vehicle. The toxic
characteristics of the vehicle should be known.
101
Appendix 3 (page 2)
TEST CONDITIONS
ACUTE ORAL
5. Administration of test
substance……………. i) The test substance should be administered in a single
dose by gavage using a tube or suitable intubation
cannula. If a single dose is not possible, the dose may
be given in smaller fractions over a period not
exceeding 24 hours.
ii)
The maximum volume of liquid that can be
administered at one time depends on the size of the
test animal. In rodents, the volume must not exceed 1
ml/100 g body weight.
6. Frequency of
observation…………..
.
7. Observation period…
8. Observation of the
animals……………….
Observations should be made frequently on the first day
of the administration and at least once each subsequent
day.
Should be at least 14 days
i) Cageside observations should include, but not limited to
changes in:
a. The skin & fur
b. Eyes & mucous membranes
c. Respiratory system
d. Circulatory system
e. Autonomic and central nervous system
f. Behavioral pattern
g. Somatomotor activity
h. Particular attention should be directed to
observation of tremors, convulsions salivation,
diarrhea, lethargy, sleep and coma.
ii) Individual weights of animals should be recorded
shortly before the test substance is administered,
weekly thereafter and at death.
iii) The time of death should be recorded as precisely as
possible.
iv) At the end of the test surviving animals should be
weighed and sacrificed.
102
Appendix 3 (page 3)
TEST CONDITIONS
9. Gross pathological
10. Data and reporting
10.1. Treatment of
results…..
10.2. Evaluation of
results…..
10.3. Test report…
ACUTE ORAL
Necropsy of animals should be carried out and all gross
pathological changes should be recorded.
Data shall be summarised in tabular form, showing for
each test group:
i) The number of animals and their body weights at
the start of the test,
ii) Time of death of animals a different dose levels,
iii) Number of animals displaying other signs of
toxicity,
iv) Description of toxic effects, and
v) Necropsy findings
An evaluation of results should include the relationship, if
any, between the dose of the test substance and the
incidence, severity and reversibility of all abnormalities,
including behavioral and clinical effects, gross lesions,
body weight changes, effects on mortality, other
toxicological effects.
The test report should include the following
information:
i) Species/strain/source used; diet, environmental
conditions,
ii) Tabulation of response date by sex and dose level (i.e.
number of animals exposed, number of animals
showing signs of toxicity; number of animals which
died or were killed during the test),
iii) Description of toxic effects
iv) Dose response curves, for mortality and other toxic
effects (when permitted by the method determination),
v) LD50 values for each sex, determined at 14 days (with
method of determination specified)
vi) 95 percent confidence interval for the LD50
vii) Time of death after dosing
viii) Body weight data
ix) Gross pathological findings.
103
Appendix 3 (page 4)
TEST CONDITIONS
10.4. Statement of
compliance..
ACUTE ORAL
The report should also include statement of compliance
signed by the study director that the test had been carried
out in compliance with Good Laboratory Practice
standards.
104
Appendix 3 (page 5)
TABLE D: PROTOCOL FOR ACUTE DERMAL TOXICITY STUDIES
TEST CONDITIONS
1. Test substance……..
ACUTE ORAL
i) If the study using the formulation as the test substance
involves any difficulty, technical material may be used in
lieu of the formulation
ii) If technical grade of active ingredient is used as the
test substance, it should be of the same composition as
that used for manufacturing the formulation.
2. Test animals……..
2.1. Species……..
2.2. Age……………..
2.3. Sex…………….
2.4. Number………..
At least one species of rat
Young adult animals should be used
Both sexes and the female should be non-pregnant
For rodents, 10 animals (5 females + 5 males) for each
dose level.
Fasting not required
2.5. Animals status…
3. Dose levels……..
4. Preparation of test
substance…………….
i) At least 3 dose levels spaced appropriately to produce
test group with a range of toxic effects and mortality rates.
The data should be sufficient to produce a dose response
curve and where possible permit an acceptable
determination of LD50.
ii) If a test at one dose level of at least 2000mg/kg body
weight on not less than 10 rats of equal numbers of sexes
using the procedures described for the study. Produces
no compound related mortality, then the full study using
the minimum three dose levels might not be necessary.
When necessary the test substance should be dissolved
or suspended in water or a suitable vehicle. The toxic
characteristics of the vehicle should be known.
105
Appendix 3 (page 6)
TEST CONDITIONS
5. Administration of test
substance…………..
6. Frequency of
observation………….
ACUTE ORAL
i) Approximately 24 hours before the test, fur
should be removed from the dorsal area of the
trunk of the test animals by clipping or shaving.
Care should be taken to avoid abrading the skin
which could alter its permeability.
ii) Not less than 10 percent of the body surface are
should be clear for the application of test
substance.
iii) When testing solids, which may be pulverised if
appropriate, the test substance should be
moistened with water or where necessary, a
suitable vehicle to ensure good contact with the
skin. When vehicle is used, the influence of the
vehicle on penetration of the skin by the test
substance should be taken into account.
iv) The test substance should be applied uniformly
over an area approximately 10 percent of the total
body surface.
v) The test substance should be held in contact with
the skin with a porous gauze dressing and nonirritating tape for 24 hours. The test site should be
further covered in a suitable manner to retain the
gauze dressing and the test substance and to
ensure that the animals cannot ingest the test
substance.
vi) At the end of the exposure period, residual test
substance should be removed, where practicable
using water or an appropriate solvent.
Observations should be made frequently on the first
day of the administration and at least once each
subsequent day.
7. Observation period…
Should be at least 14 days
8. Observation the
animals………………
i)
Cageside observations should include, but not
limited to changes in:
a. The skin & fur
b. Eyes & mucous membranes
c. Respiratory system
e. Circulatory system
106
Appendix 3 (page 7)
TEST CONDITIONS
ACUTE ORAL
e. Autonomic and central nervous system
f. Behavioral pattern
g. Somatomotor activity
h. Particular attention should be directed to
observation of tremors, convulsions, salivation,
diarrhea, lethargy, sleep and coma.
ii) Individual weights of animals should be recorded
shortly before the test substance is administered,
weekly there after and at death.
iii) The time of death should be recorded as precisely as
possible.
iv) At the end of the test surviving animals should be
weighed and sacrificed.
9. Gross pathological.
10. Data and reporting.
10.1. Treatment of
results…..
10.2. Evaluation of
results…….
10.3. Test report…..
Necropsy of animals should be carried out and all gross
pathological changes should be recorded.
Data shall be summarised in tabular form, showing for
each test group:
i)
The number of animals and their body weights
at the start of the test,
ii)
Time of death of animals at different dose
levels,
iii)
Number of animals displaying other signs of
toxicity,
iv)
Description of toxic effects, and
v)
Necropsy findings.
An evaluation of results should include the relationship, if
any, between the dose of the test substance and the
incidence, severity and reversibility of all abnormalities,
including behavioral and clinical effects, gross lesions,
body weight changes, effects on mortality, other
toxicological effects.
The test report should include the following information:
i)
Species/strain/source used; diet, environmental
conditions,
107
Appendix 3 (page 8)
TEST CONDITIONS
ACUTE ORAL
ii)
iii)
iv)
v)
vi)
vii)
viii)
ix)
10.4. Statement of
compliance…
Tabulation of response data by sex and dose level
(i.e. number of animals exposed, number of
animals showing signs of toxicity; number of
animals which died or were killed during the test),
Description of toxic effects
Dose response curves, for mortality and other toxic
effects (when permitted by the method of
determination)
LD50 values for each sex, determined at 14 days
(with method of determination specified)
95 percent confidence interval for the LD50
Time of death after dosing
Body weight data
Gross pathological findings.
The report should also include statement of compliance
signed by the study director that the test had been carried
out in compliance with Good Laboratory Practice
standards.
108
GP 3/93
GUIDELINES ON
EFFICACY DATA REQUIREMENTS
FOR
PESTICIDE REGISTRATION
Pesticides Board
Malaysia
2009
109
Efficacy Data Requirement for
Pesticide Registration
__________________________________________________
Substantiation of claims made on the efficacy of a product submitted for registration is
a requirement under the Pesticides Act 1974. To assist applicants in their submission
for registration, the following additional guidelines have been prepared. Applicants are
advised to follow the harmonised protocols developed under the FAO through its
Regional Project on the Implementation of the Code of Conduct on the Distribution
and Use of Pesticides (GCP/ITN/456/JPN). Appendix 1 shows the protocols presently
available. In cases where there are no harmonised protocols, applicants are advised
to use the following general guidelines.
A.
GENERAL REQUIREMENTS
1.
For all proprietary pesticides recommended to be used on major crops i.e. rice,
oil palm, cocoa, and rubber, efficacy evaluation results obtained from local verification
trials is required. For other crops, result(s) obtained from trials conducted in other
countries under similar climatic regime and cultural practice may be considered.
2.
For commodity products efficacy data is not required if label claim is similar to
that shown in the “Approved Uses for Commodity Pesticides”, document number
GP5/93. Any other additional claim(s) must be substantiated with data.
B.
GUIDELINES FOR EFFICACY EVALUATION OF INSECTICIDES
USED IN AGRICULTURE.
1.
Experimental Conditions
1.1
Selection of crop and cultivar, test organisms – The selection of crop,
cultivar, and insects must be relevant to the (proposed) label claims.
1.2
Trial Conditions – Trials should be conducted only on crops with known
history of uniform high infestation of the targeted pest(s). Cultural conditions e.g. soil
type, fertilizers, tillage, row spacing etc. should be uniform for all plots of the trial and
should conform with local agricultural practices. The timing, amount and method of
irrigation, if applied, should be recorded. Trials should be carried out in different
regions with distinct environmental conditions and preferably in different planting
seasons (where applicable).
1.3
Treatments – Test product(s), reference product(s) and untreated control,
arranged in a randomized block or any other statistically suitable design.
1.4
Plot size and replication – Net plot size: at least 15 square meters or 25
plants depending on type of plants, formulation of insecticides, and type of equipment
to be used in applying the insecticides.
Replicates: at least three, provided the error degrees of freedom are at least 12.
110
2.
2.1
Application of Treatments
Test Product(s) – The formulated product under investigation.
2.2
Reference Product(s) – Registered product known to be satisfactory for the
control of the insect pest(s) under investigation. In general, formulation, type and
mode of action should be close to those of the test product(s).
2.3
Mode of
practice.
2.4
Application – Application should comply with good agricultural
Type of Application – as specified on the (proposed) label.
2.5
Type of equipment used – should be of a type in current use .It should
provide an even distribution of product on the whole plot or accurate directional
application where appropriate. Factors which may affect efficacy (such as operating
pressure, nozzle type, depth of incorporation) should be recorded, together with any
deviations in dosage of more than 10%.
Precaution should be taken to avoid drift between plots.
2.6
Time and frequency of application – The time and frequency of application
will normaly be specified on the (proposed) label. The number of application and the
date of each application should be recorded.
2.7
Doses and volumes used – According to instructions on the (proposed) label.
The products should be tested at the recommended dose and may also usefully be
tested at other doses. The dosage will normally be expressed in kg or 1 of formulated
product per ha. It may also be useful to record the dose in g of active ingredient per
ha. For sprays, data on concentration (%) and volume (1/ha) should also be given.
2.8
Data on chemicals used against other pests – If other chemicals have to be
used, they should be applied uniformly to all plots, separately from test product(s) and
reference product(s). Possible interference with these should be kept to a minimum.
Precise data on the applications should be given.
3.
Assessment, Recording and Measurements
3.1
Meteorological and edaphic data – On the date of application, meteorological
data which are likely to affect the quality and persistence of the treatment should be
recorded. This normally includes at least precipitation (type and amount in mm) and
temperature (average, maximum, minimum in oC) Any significant change in weather
should be noted, and in particular its time relative to the time of treatment. Around the
date of application, meteorological data should be recorded which are likely to affect
the development of the crop and/ or pests and the action of the insecticide.
Throughout the trial period, extreme weather conditions, such as severe or
prolonged drought, heavy rain, hail etc., which are likely to influence the results,
should be reported.
111
3.2
Edaphic data – Depth of water
layer, over-flowing water or drainage,
excessive algal growth or excessive organic matter content of water or soil should be
recorded.
3.3
Type, time and frequency of assessment – Type of assessment depends on
the type of pest(s) but normally by number of insects on all plants in the trial.
Preliminary assessment is done immediately before treatment; first assessment 1-3
days after treatment; second assessment 7 – 14 days after treatment. If long-term
effects are claimed, further assessments at 14 days intervals should be carried out.
3.4
Direct effects on the crop – The crop should be examined for presence or
absence of phytotoxic effects. The type and extent of these should be recorded. In
addition, any positive effects should be noted.
Phytotoxicity is recorded as follows:
(a)
if the effect can be counted or measured, it may be expressed in
absolute figures;
(b)
in other cases, the frequency and intensity of damage may be estimated.
This may be done in either of two ways: each plot is scored for
phytotoxicity by reference to a scale which should be recorded; or each
treated plot is compared with an untreated plot and % phytotoxicity
estimated.
In all cases, symptoms of damage to the crop should be accurately described
(stunting, chlorosis, deformation, etc.). Should symptoms of phytotoxicity be detected,
a more detailed assessment should be carried out following the FAO Guidelines for
Phytotoxicity Assessment (FAO/AP/027).
3.5
Effects on other pests – Any effects, positive or negative, on the incidence of
other pests should be noted.
3.6
Effects on other non-target organisms – Any observed environmental effects
should also be recorded, especially effects on wildlife and/or beneficial
organisms. Any observed effects on human safety should also be recorded.
3.7
Quantitative and/ or qualitative recording of yield – Quantitative yield
recording is not required, but any effects on the quality of the product should be
noted (e.g. marketability of produce).
4.
Results
4.1
The results should be reported in a systematic form and the report should
include an analysis and evaluation. Original (raw) data should be available. Statistical
analysis should be used, where appropriate, by methods which should be indicated.
For further details, refer to Appendix 2.
112
C.
GUIDELINES FOR EFFICACY EVALUATION OF FUNGICIDES
USED IN AGRICULTURE.
1.
Experimental Conditions
1.1. Selection of crop and cultivar, test organisms – The selection of crop,
cultivar, and pathogens must be relevant to the proposed label claims.
1.2. Trial Conditions – Trials should be conducted only on crops with known
history of uniform high infestation of the target diseases. Cultural conditions e.g. soil
type, fertilizers, tillage, row spacing etc. should be uniform for all plots of the trial and
should conform with local agricultural practices. The timing, amount and method of
irrigation, if applied, should be recorded. Trials should be carried out in different
regions with distinct environmental conditions and preferably in different planting
seasons where applicable.
1.3. Treatments – Test product(s), reference product(s) and untreated control,
arranged in a randomized block or any other statistically suitable design.
1.4
Plot size and replication – Net plot size: for tree crops such as oil palm,
rubber, cocoa and citrus at least 4 trees depending on type of plants, diseases,
formulation of fungicides, and type of equipment to be used in applying the fungicides.
Replicates: at least three, provided the error degrees of freedom are at least 12.
2.
Application of Treatments
2.1
Test Product(s) – The formulated products under investigation.
2.2. Reference Product(s) – Registered product known to be satisfactory for the
control of the disease(s) under investigation. In general, formulation, type and mode of
action should be close to those of the test product(s).
2.3
Mode of Application – Application should comply with good agricultural
practice.
2.4
Type of application – As specified on the (proposed) label.
2.5
Type of equipment used – should be of a type in current use. It should
provide an even distribution of product on the whole plot or accurate directional
application where appropriate. Factors which may affect efficacy (such as operating
pressure, nozzle type) should be recorded, together with any deviations in dosage of
more than 10%.
Precaution should be taken to avoid drift between plots.
2.6
Time and frequency of application – The time and frequency of application
should correspond to that specified on the (proposed) label. The number of application
and the date of each application should be recorded.
113
2.7
Doses and volumes used – According to instructions on the (proposed) label.
The product should be tested at the recommended dose and may also usefully be
tested at other doses. The dosage will normally be expressed in kg or 1 of formulated
product per ha. It may also be useful to record the dose in g of active ingredient per
ha. For sprays, data on concentration (%) and volume (1/ha) should also be given.
2.8
Data on chemicals used against other pests – If other chemicals have to be
used, they should be applied uniformly to all plots, separately from test product(s) and
reference product(s). Possible interference with these should be kept to a minimum.
Precise data on the applications should be given.
3.
Assessment, Recording and Measurements
3.1
Meteorological and edaphic data – On the date of application, meteorological
data should be recorded which are likely to affect the quality and persistence of the
treatment. This normally includes at least precipitation (type and amount in mm) and
temperature (average, maximum, minimum in oC). Any significant change in weather
should be noted, and in particular its time relative to the time of treatment. Around the
date of application, meteorological data should be recorded which are likely to affect
the development of the crop and/ or disease(s) and the action of the fungicide.
Throughout the trial period, extreme weather conditions, such as severe or
prolonged drought, heavy rain, hail etc., which are likely to influence the results,
should be reported.
3.2
Edaphic data – Depth of water layer, over-flowing water or drainage,
excessive algal growth or excessive organic matter content of water or soil should be
recorded.
3.3
Type, time and frequency of assessment – Type of assessment depends on
the disease(s) under investigation but normally by % infestation per unit area of plant
parts on all plants in the trial. A practical scale for assessment should be used.
Preliminary assessment is done immediately before treatment;
1st assessment – 1 to 3 days after treatment;
2nd assessment – 7 to 14 days after treatment;
If long-term effects are claimed, further assessments at 14 days intervals
should be carried out.
For diseases which are long term such as root diseases, the symptoms of
infestation on the whole tree e.g. wiltering, crown collapse etc. can be taken.
114
3.4
Direct effects on the crop – The crop should be examined for presence or
absence of phytotoxic effects. The type and extent of these should be recorded. In
addition, any positive effects should be noted.
Phytotoxicity is recorded as follows:
(a)
if the effect can be counted or measured, it may be expressed in
absolute figures;
(b)
in other cases, the frequency and intensity of damage may be estimated.
This may be done in either of two ways: each plot is scored for
phytotoxicity by reference to a scale which should be recorded; or each
treated plot is compared with an untreated plot and % phytotoxicity
estimated.
In all cases, symptoms of damage to the crop should be accurately described
(stunting, chlorosis, deformation, etc.) Should symptoms of phytotoxicity be detected,
a more detailed assessment should be carried out following the FAO Guidelines for
Phytotoxicity Assessment (FAO/AP/027).
3.5
Effects on other pests – Any effects, positive or negative, on the incidence of
other pests should be noted.
3.6
Effects on other non-target organisms – Any observed environmental effects
should also be recorded, especially effects on wildlife and/or beneficial organisms.
Any observed effects on human safety should also be recorded.
3.7
Quantitative and/or qualitative recording of yield – Quantitative yield
recording is not required, but any effects on the quality of the product should be noted
(e.g. marketability or produce).
4.
Results
4.1
The results should be reported in a systematic form and the report should
include an analysis and evaluation. Original (raw) data should be available. Statistical
analysis should be used, where appropriate, by methods which should be indicated.
For further details, refer to Appendix 2.
D.
GUIDELINES FOR EFFICACY EVALUATION OF HERBICIDES
1.
The biological evaluation of a herbicide involves a programme of trials for
assessment of efficacy in weed control and of selectivity to the crop (crop safety).
Trials may be used either for evaluating weed control or crop safety according to weed
occurrence, provided the conditions specified in the test protocol are satisfied.
115
2.
Experimental Conditions
2.1
Selection of crop, cultivar and weeds – The selection of crop, cultivar, and
weeds must be relevant to the (proposed) label claims. Consideration with regard to
crop safety may also be given to cover crops, where applicable, which may be sown
together with the primary crop. If crop safety of more than one cultivar needs to be
tested, special varietal trials should be carried out.
2.2
Evaluation of efficacy in weed control – The plots should be known to carry
a varied but uniform weed population. The weed population should correspond to the
specific action spectrum of the herbicide to be tested (e.g. grasses, sedges and/or
broadleaf weeds, annuals and/or perennials).
2.3
Evaluation of crop safety – The plots should preferably be as free from
weeds as possible. Other herbicides should not be used, unless one is certain that
they have no effect on the crop and do not interact with the test product(s) or
reference product(s). If any weeds remain, they should preferably removed by hand or
mechanically.
2.4
Trial Conditions – Cultural conditions e.g. soil type, fertilizers, tillage, row
spacing etc. should be uniform for all plots of the trial and should conform with local
agricultural practices. The timing, amount and method of irrigation, if applied, should
be recorded. Trials should be carried out in different regions with distinct
environmental conditions and preferably in different planting seasons where
applicable.
2.5
Treatments – The product(s) and reference product(s) at individual doses
and/or application times, and untreated control(s), arranged in a randomized block or
any other statistically suitable design.
2.6
Plot size and replication – Net plot size: at least 10 meter square depending
on type of plants, mode of application of the herbicide(s), and type of equipment to be
used in applying the herbicide(s). For crop safety tests the net plot size should be at
least 4 plants. Depending on the type of application, actual plot size may have to be
larger than net plot size in order to take account of possible drift.
Replicates: at least three, provided the error degrees of freedom are at least 12.
116
3.
Application of Treatments
3.1
Test Product(s) – The formulated product under investigation.
3.2
Reference Product(s) – Registered product(s) known to be satisfactory for the
control of the weed types under investigation. In general formulation type and mode of
action should be close to those of the test product(s)
3.3
Mode of Application – Application should conform with good agricultural
practice.
3.4
Type of application – The type of application as specified on the (proposed)
label.
3.5
Type of equipment used – The equipment should be of a type in current use.
It should provide an even distribution of product(s) on the whole plot or accurate
directional application where appropriate. Factors which may affect efficacy and/or
duration of weed control and/or crop safety (such as operating pressure, nozzle type,
depth of incorporation) should be recorded, together with any deviations on dosage of
more than 10%.
Precaution should be taken to avoid drift between plots.
3.6
Time and frequency of application – The time and frequency of application
should correspond to that specified on the (proposed) label. Application times should
be related to the emergence of the crop and of the weeds. The same product may be
applied once or in follow up application.
The number of applications and the date of each application should be recorded.
3.7
Doses and volumes used – According to instructions on the (proposed) label.
The product(s) should be tested at the recommended dose and may also usefully be
tested at other doses. The dosage will normally be expressed in kg or 1 of formulated
product per ha. It may also be useful to record the dose in g of active ingredient per
ha. For sprays, data on concentration (%) and volume (1/ha) should also be given.
3.8
Data on chemicals used against other pests – If other chemicals have to be
used, they should be applied uniformly to all plots, separately from test product(s) and
reference product(s). Possible interference with these should be kept to a minimum.
Precise data on the applications should be given.
117
4.
Assessment, Recording and Measurements
4.1
Meteorological and edaphic data – On the date of application, meteorological
data should be recorded which are likely to effect the quality and persistence of the
treatment. This normally includes at least precipitation (type and amount in mm) and
temperature (average, maximum, minimum in oC). Any significant change in weather
should be noted, and in particular its time relative to the time of treatment. Around the
date of application, meteorological data should be recorded which are likely to affect
the development of the crop and/or weeds and the action of the herbicides.
Throughout the trial period, extreme weather conditions, such as severe or prolonged
drought, heavy rain, hail etc., which are likely to influence the results, should be
reported.
4.2
Edaphic data – The following characteristics of the of the soil should be
recorded: pH, organic matter content, soil type (according to a specified national or
international standard), moisture (e.g. dry, wet, waterlogged), seed bed quality (tilth)
and fertilizer regime.
4.3
Observation on weeds – The weed population of a plot can be recorded in
terms of numbers, cover or mass (normally dry weight). These may be assessed in
absolute terms and/or estimated.
4.3.1 Absolute assessment
Individual plants may be counted for each weed species or the mass of each
species may be determined by weighing (normally dry weight). These assessments
can be made on whole plots or on randomly selected marked quadrats (up to 1 m sq.)
in each plot. In certain cases, it may be preferable to count or measure particular plant
organs (e.g. flowering or fruiting tillers in weeds).
4.3.2 Estimation
Each treated plot is compared with an adjacent untreated plot or control strip,
and the relative weed population is estimated. The assessment involves a general
estimation of the total weed population or of individual weed species, combining in
one figure an estimate of number, cover, height and vigour (i.e. virtually weed
volume). It is in principle rapid and simple. The result may be expressed simply as a
percentage (i.e. on a linear scale from 0 = no weeds to 100 = same weed infestation
as untreated). An equivalent inverted scale may be used to express percent weed
control (0 = no weed control, 100 = full weed control). Information should also be
provided on the absolute level of weed infestation in the untreated plots or strips
(absolute assessment of weed cover). In order to describe exactly the mode of action
of the product, symptoms of damage to the weeds should be accurately described
(stunting, chlorosis, deformation, etc.).
Effects on weeds can usefully be noted over 2 seasons. This is essential for
deep rooted or difficult weeds (such as Cyperus rotundus, Imperata cylindrical) as
they may not be killed and might reappear the following year.
118
4.4
Observation on the crop – Phytotoxicity is evaluated primarily on crop safety
plots which are also harvested. However, the type and extent of damage to the crop
should be recorded on efficacy plots and may provide useful additional information.
Phytotoxicity is recorded as follows:
(a)
if the effect can be counted or measured, it may be expressed in
absolute figures;
(b)
in other cases, the frequency and intensity of damage may be estimated.
This may be done in either of two ways: each plot is scored for
phytotoxicity by reference to a scale which should be recorded; or each
treated plot is compared with an untreated plot and % phytotoxicity
estimated.
In all cases, symptoms of damage to the crop should be accurately described
(stunting, chlorosis, deformation, etc.). Should symptoms of phytotoxicity be detected,
a more detailed assessment should be carried out following the FAO Guidelines for
Phytotoxicity Assessment (FAO/AP/027).
4.5
Observation on side-effects – Any effects on non-target organisms should be
recorded.
4.6
Time and frequency – The times given apply to weed control and crop safety
assessment, unless otherwise indicated. Frequency of assessment should cover
possibility of regrowth.
(a)
(b)
Pre-emergence applications:
1st assessment –
when approximately 90 % of the crop has
emerged in the untreated plot.
2nd assessment –
20 to 30 days after treatment.
rd
3 assessment –
60 days after application.
4th assessment –
before harvest.
Post-emergence applications:
1st assessment (preliminary)
–
on the day of treatment,
the weed and crop cover in each
plot should be recorded.
2nd assessment (weed control only) –
3 to 5 days after treatment.
rd
3 assessment –
10 to 20 days after treatment.
4th assessment –
30 to 50 days after treatment.
th
5 assessment –
before harvest.
4.7
Quantitative and/ or qualitative recording of yield – For crop safety testing
and weed control testing harvesting is optional in most cases.
5.
Results
5.1
The results should be reported in a systematic form and the report should
include an analysis and evaluation.
Original (raw) data should be available. Statistical analysis should be used, where
appropriate, by methods which should be indicated. For further details, refer to
Appendix 2.
119
E.
GUIDELINES FOR BIOLOGICAL EVALUATIONS
INSECTICIDE PRODUCTS IN THE LABORATORY
1.
Experimental Conditions
OF
HOUSEHOLD
1.1
Equipments and test organisms – A transparent glass chamber or Peet
Grady chamber (between 70 x 70 x 70cm to 180 x 180 x 180cm) and laboratorycultured adult insects of known age group (eg. sucrose-fed female mosquitoes aged 2
– 5 days) should be used. In case of mosquitoes Aedes aegypti or Culex
quinquefasciatus, being easily available, are the preferred species.
1.2
Treatments and Replicates – Test product(s) and reference product(s) should
be tested and replicated at least three times.
2.
Application of Treatments
2.1
Test Product(s) – The formulated product(s) under investigation.
2.2
Reference Product(s) – Registered product(s) known to be satisfactory for the
control of the household insect pest(s) under investigation.
2.3
Mode of Application – Application method should correspond to the method
proposed on the label.
2.4
Type of equipment used – should be of a type in current use. It should
provide an even distribution of product in the test chamber.
2.5
Doses and volumes used – According to instructions on the (proposed) label.
The product should be tested at the recommended dose and at other doses where
appropriate.
3.
Assessment and Recording.
3.1
Type, time and frequency of assessment – Assessment should be by
number of insects knocked down observed at indicated intervals up to 20 minutes.
Mortality after 24 hours posttreatment should be recorded.
4.
Results
4.1
The results should be reported in a systematic form and the report should
include an analysis and evaluation. Original (raw) data should be available. Statistical
analysis should be used, where appropriate, by methods which should be indicated.
For further details, refer to Appendix 3.
120
5.
General
5.1
Applicants are advised to follow the test methods stated in the following
documents.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Glass Chamber Method for testing mosquito coils (SIRIM MS 23);
Peet Grady Chamber Method for testing mosquito coils
Glass Chamber Method for testing mosquito mats (SIRIM MS 1044);
Peet Grady Chamber Method for testing mosquito mats;
Glass Chamber Method for testing of aerosols against mosquitoes
(SIRIM MS 1186);
Peet Grady Chamber Method for testing of aerosols against mosquitoes;
Glass Cylinder Method for testing of aerosols on cockroaches (SIRIM
MS 1100);
Residual tests on polywood plate/ cement block for cockroaches (SIRIM
MS 1130);
In cases where there are no test methods specified applicants are advised to use the
above guidelines.
121
Appendix 1
LIST OF HAMONISED BIOEFFICACY PROTOCOLS
FAO/AP/001
FAO/AP/002
FAO/AP/003
FAO/AP/004
FAO/AP/005
-
FAO/AP/006
FAO/AP/007
FAO/AP/008
FAO/AP/009
FAO/AP/010
FAO/AP/011
FAO/AP/012
FAO/AP/013
FAO/AP/014
FAO/AP/015
FAO/AP/016
FAO/AP/017
FAO/AP/018
FAO/AP/019
FAO/AP/020
FAO/AP/021
FAO/AP/022
FAO/AP/023
FAO/AP/024
FAO/AP/025
FAO/AP/026
FAO/AP/027
FAO/AP/028
FAO/AP/029
FAO/AP/030
FAO/AP/031
FAO/AP/032
FAO/AP/033
FAO/AP/034
FAO/AP/035
FAO/AP/036
FAO/AP/037
FAO/AP/038
FAO/AP/039
FAO/AP/040
-
Planthoppers on Rice
Stemborers on Rice
Leafhoppers on Rice
Plutella xylostella
Alternaria solani and Phytophthora infestans on
tomato
Phytophthora infestans on Potato.
Weeds in Rice.
Weeds in Sugarcane.
Weeds in Maize.
Weeds in Banana.
Seed Bugs on Rice.
Rice Water Weevil.
Leaf Folders on Rice.
Sheath Blight of Rice.
Blast Disease of Rice.
Mites on Citrus.
Scale Insects on Citrus.
Heliothis armigera on Citrus.
Citrus Leafminer.
Webworm and Heartworm on Cabbage.
Anthracnose of Capsicum spp.
Corn Borers on Maize.
Bollworms on Cotton.
Rice Hispa.
Apple Scab.
Armyworms on Maize.
Guidelines for Phytotoxicity Assessment.
Sucking Insect Pests of Cotton.
Mites on Apple.
Aphids on Apple.
Whorl Maggots on Rice.
Black Bugs on Rice.
Weeds on Oil Palm and Rubber.
Weeds on Phaseolus, Pisum and Vigna.
Blue Mould of Tobacco.
Fruit Flies on Cucurbits.
Hoppers on Mango.
Fruit Flies on Mango.
Codling Moth on Apple.
Numerical Code for the Growth Stages of the Rice Plant.
122
Appendix 2
GUIDELINES FOR REPORTING OF EFFICACY EVALUATION
It is essential that the presentation of the results should be standardized in
order to facilitate understanding of the trial results. Therefore, the data should
preferably be presented in the following way:
-
name of the experimenter and organization responsible for the trial;
objective and location of the trial;
chemical name and formulation;
insect pest, disease or weed against which tested;
crops and cultivars;
plant growth stage;
soil type;
experimental design, size and number of plots treated;
application dates and rates;
application method and equipment;
volume of spray liquid or other carrier types;
weather conditions during and after treatment;
treatment of the plots with other crop protecting materials, fertilizers and
other products;
application dates;
dates of assessment;
size and frequency of sampling;
quantity and quality of yield of the harvested crop where required;
any results on crop safety including intervals to be observed in order to
avoid phytotoxic effects;
data assessment including significance;
interpretation and discussion on the results of the experiment in comparison
with similar trials.
123
Appendix 3
GUIDELINES FOR REPORTING OF LABORATORY
BIOLOGICAL EVALUATIONS OF HOUSEHOLD INSECTICIDE PRODUCTS
The data obtained from laboratory evaluations of household insecticide
products should preferably be presented in the following manner:
-
name of the experimenter and organization responsible for the test(s);
objective of the test(s);
chemical name and formulation;
insect pest(s) against which tested;
sample size and number of replicates tested;
evaluation dates and rates;
evaluation method and equipment;
volume of spray and/ or duration of exposure of test insects;
dates of assessment;
data assessment including significance;
interpretation and discussion on the results of the test(s).
124
GP4/2012
GUIDELINES ON RESIDUE
DATA REQUIREMENTS
FOR PESTICIDE
REGISTRATION
PESTICIDE BOARD
MALAYSIA
125
TABLE OF CONTENT
Glossary ……………………………………………………………………………
Guidelines on Residue Data Requirements for Pesticide Registration………
Introduction………………………………………………………………….
Requirements……………………………………………………………….
Residue Trials……………………………………………………………….
Residue Trial Report………………………………………………………..
Residue Analysis Report…………………………………………………..
References……………………………………………………………………
Appendix
Appendix I - Index of Classes, Types and Groups of Commodities…
Appendix II - Reporting Protocol for Pesticide Residue Trials……….
A) Paddy………………………………………………………………
B) Oil Palm……………………………………………………………
C) Cocoa………………………………………………………………
D) Pepper …………………………………………………………….
Appendix III - List of Residue Data Exemption ………………………..
Checklist on Residue Data Requirement………………………………………..
126
GLOSSARY
pesticide residue
"Pesticide residue" means any specified substances in
food, agricultural commodities, or animal feed resulting
from the use of a pesticide. The term includes any
derivatives of a pesticide, such as conversion products,
metabolites, reaction products, and impurities considered
to be of toxicological significance. (Note: The term
"pesticide residue" includes residues from unknown or
unavoidable sources (e.g., environmental), as well as
known uses of the chemical).
MRL
Maximum Residue Limit
"MRL" is the maximum concentration of a pesticide residue
(expressed as mg/kg), recommended to be legally
permitted in or in food commodities and animal feeds.
MRLs are based on GAP data and commodities that
comply with the respective MRLs are intended to be
toxicologically acceptable
PHI
Pre Harvest Interval
“Pre Harvest Interval” is the time interval between the last
pesticide application and harvest of the treated crops.
PSI
Pre Slaughter Interval
“Pre Slaughter Interval” is the time interval between the
last pesticide application and slaughter of the treated
animal.
proprietary products
Any pesticide registered in Malaysia less than ten years
commodity products
Any pesticide which is not a proprietary pesticide
new recommendations
supervised residue trials
New crop recommended for any commodity pesticide
Residue trial designed in line with the requirements stated
in ‘Supervised Residue Trials in Crops and Plant Products,
part 3 of ‘FAO/WHO Codex Alimentarius Commission
Guidelines on Producing Residues Data from Supervised
Trials, 1990’.
local conditions
Local agriculture conditions that follow national GAP, which
include weather, rainfall broadcast and climatic changes.
127
ADI
Acceptable Daily Intake
"ADI" of a chemical is the daily intake which, during an
entire lifetime, appears to be without appreciable risk to the
health of the consumer on the basis of all the known facts
at the time of the evaluation of the chemical. It is
expressed in milligrams of the chemical per kilogram of
body weight.
NOAEL
No Adverse Effects Level
“No Adverse Effects Level” is the highest level of continual
exposure to a chemical which causes no significant
adverse effect on morphology, biochemistry, functional
capacity, growth, development or life span of individuals of
the target species which may be animal or human
Limit of Determination
"Limit of determination" is the lowest concentration of a
pesticide residue or contaminant that can be identified and
quantitatively measured in a specified food, agricultural
commodity, or animal feed with an acceptable degree of
certainty by a regulatory method of analysis.
pre-mixture product
Combination of an authorised pre-mix and one or more
active ingredient which are intended for the subsequent
manufacture of a ready to use crop protection product
field experiments
Experiment, research or trial conducted under actual
use condition, instead of other controlled condition in
the laboratory.
128
Guidelines On
Residue Data Requirements
For Pesticide Registration
A.
INTRODUCTION
Residue data is required for registration of pesticides in order to:
(a) ensure that any residue of pesticides at the time of harvest
does not exceed the maximum residue limits (MRLs), or in the
absence of MRLs, either to enable MRLs to be established or
to establish that MRLs are not necessary;
(b)
recommend a suitable waiting period between the last
application and harvest/slaughter (pre-harvest interval, PHI/
pre-slaughter interval, PSI) or consumption of the commodity
so that residues of pesticides would not exceed MRLs or in
the absence of MRLs, are at levels which would not be of
concern to human and animal health, and
(c)
ensure that a workable method is available to analyze for
pesticide residues in food and/ or in the environment.
B.
REQUIREMENTS
The following requirements must be submitted:
1.
For all products, a proposed label with clear instructions on how
the pesticide is to be used. This is to enable correlation of the
proposed use patterns with the method of application used in
obtaining the residue data. The following must be clearly stated:
(a)
The target crop, stored product or livestock.
(b)
The method of application. This includes information on the
equipment used, dosage (expressed as unit a.i. per unit
area/volume), number of applications, timing of applications,
etc.;
(c)
The stage of growth of the crop or the livestock when the
pesticide is applied, if applicable; and
(d)
The recommended PHI, PSI, re-entry time, aeration period
and other observations and limitations.
129
2.
For proprietary products
only, information on the
physical, chemical and biological properties of the pesticide,
nature and amounts of isomers, impurities and by-products which
may be present in the technical or formulated products.
3.
For proprietary products only, information on the behavior and
metabolism/ degradation of the pesticide in crops and plant/
animal products and soil and the nature of the residues as well
as its degradability as indicated by its half-life (t½) in soil and
water at 25o C and its mobility in soils as indicated by adsorption
studies. The metabolism studies are to characterize the residues,
usually by employing radio-labeled compounds. Information on
the amount of bound residues in soil and plants and their bioavailability may also be requested. For studies with livestock, the
study should indicate the distribution of residues in tissues, milk
or eggs and whether the residues are accumulated in any part of
the animal.
4.
For proprietary products, and commodity products with new
recommendations, detailed reports on supervised residue trials.
Trials must be carried out on the recommended crops, livestock
and stored products with the pesticides applied in the same
manner as in the proposed label. In addition to the proposed
label rates, an exaggerated rate (usually 2 times the proposed
rate) should be studied. Studies should preferably be conducted
under local conditions or in locations with similar conditions.
5.
In addition the design and implementation of supervised residue
trials should follow proposed critical Good Agriculture Practice
(GAP) (maximum number of applications, timing of application(s)
at the latest stage permitted within application scope, maximum
application rate, minimum PHI/PSI), which would likely result in
maximum residue. Other factors such as weather condition and
agronomic/husbandry practice should also be considered when
designing supervised residue trials.
6.
For proprietary products and commodity products with new
recommendations, a method of analysis for residues of the
pesticide in the relevant matrix. For pesticides not used on food
or on animals for consumption, a method of analysis for residues
in the environment is required. The method can be a company
method or a published method for which the source must be
given. For methods to be accepted, the % recovery must be
within the range of 70%-120%. If 70%-120% recovery is not
130
attainable,
methods having lower recoveries may be
accepted if consistency can be shown. The recovery tests should
be at levels found in practice and actual analysis of treated
samples. Evidence on the workability, reproducibility, selectivity
and sensitivity of the method must be submitted.
7.
Information on MRL enforcement method (or known as postregistration method) should also be provided if possible. MRL
enforcement method is usually in the form of multi-residue
method used by regulatory authorities in enforcement of MRLs.
Single-residue method may not be suitable for MRL enforcement
as enforcement laboratories do not have sufficient capacity to
perform single-residue methods on all pesticides. However
certain active ingredients may not be suitable to be detected by
enforcement method. Registrant should consult the Pesticide
Board for possible establishment of enforcement method.
8.
For proprietary products, and commodity products with new
recommendations, proposals of PHI/PSI, other limitations and
MRLs. The basis of the proposals must be clearly given and
related to the residue and other data submitted. A statement on
the Acceptable Daily Intake (ADI) and No Observed Adverse
Effect Level (NOAEL) as derived from the toxicological data must
be submitted. Similar information from other countries or
international organizations should also be submitted as
additional information.
Additional information in the form of summaries of residue trials
may also be submitted but the complete report must be available
on request. Evaluations by the FAO/WHO Joint Meeting on
Pesticide Residues (JMPR) are acceptable as additional
information ONLY and cannot replace actual residue studies.
If residue trial information on a particular commodity is not
available, the applicant may request for information on a
representative commodity to be accepted. See Appendix I for the
grouping of commodities and the commodity which may be
regarded as representative of those in the group. The onus is on
the applicant to request for extrapolation of the data.
Residue data generated under local conditions is preferred but
data from other countries/locations with similar condition which
reflect the principal growing regions of the recommended crop
may be accepted. Published reports on relevant trials by
researchers are acceptable as additional information.
9.
10.
11.
131
12.
13.
C.
For major crops, which are paddy, palm oil, cocoa beans, and
black pepper, at least one field experiment must be generated
under local condition.
Residue trials on certain commodities may not be required under
certain situations such as when an insecticide/ fungicide is
applied as a seed treatment or at the nursery stage of a
perennial crop. (see Appendix III for the list of residue data
exemption)
RESIDUE TRIALS
1.
The FAO Guidelines on Producing Pesticide Residues Data from
Supervised Trials, 1990, Part 3 on Residue Trials in Crops
should be used as a basis in the design and execution of residue
field trials. Where appropriate, Good Laboratory Practices (GLP)
should be followed in carrying out the studies.
2.
For crops not included in the Codex Classification of Foods and
Animal Feeds (Guide to Codex Recommendations concerning
Pesticide Residues, Part 4), the applicant is advised to submit a
proposed residue trial protocol to the Pesticides Board for
approval before commencing the trial. Appendix II contains
examples of protocols for residue trials on oil palm and cocoa
and residue requirements.
3.
Field experiments must reflect the proposed use with respect to:
 The rate and mode of application;
 The number and timing of applications and
 The formulations proposed
132
4.
The location of the field experiments should reflect the principal
growing regions of the crop.
The field experiments must provide for residue dissipation or
decline studies in which samples are taken at intervals during the
period from the last applications of the pesticide to normal
harvest. Sample for residue analysis must be taken at different
period after the last application of the pesticide. The first
sampling shall be done 2 hour after application (0 day). Sample
shall be taken at least 4 times at various intervals depending on
characteristic of pesticide and crop. The data obtained should
indicate the pattern of uptake of the pesticide and its decline.
5.
For pre-mixture product, a residue trial data based on a single
active ingredient of the pre-mixture product is not accepted.
6.
At least three field experiments done at different sites must be
submitted. Replicate treatment of individual sites is usually not
necessary since within-site variations are usually small compared
to the variation between sites.
7.
For fumigation trials on store products, the studies should
adequately represent those commodities which might be treated,
such as oily foods (nuts, copra), and high surface area foods
(flour). The studies should reflect the effect of parameters such
as temperature, time of exposure, dosage, pressure, aeration
time etc. on the residue reduction.
8.
For studies on livestock, data must show the level of residues
that will result in the meat (muscle, liver, kidney and fat), poultry,
(muscle, liver, kidney and fat), eggs and milk. The FAO
Guidelines on Producing Pesticide Residues Data from
Supervised Trials, 1990, Part 4 on Metabolism Studies and
Supervised Residue Trials in Animals may be used in carrying
out the studies.
9.
Additional information on the reduction or concentration of
residues due to post-harvest processing or household cooking
would also be useful.
10.
All data belonging to another company can only be evaluated if a
letter of authorization is given.
133
D.
RESIDUE TRIAL REPORT
1.
The behavior of the pesticide deposit from application until
harvest, possible formation of metabolites and identity of the
metabolites should be reported in order to predict residue levels
at harvest and to reach a preliminary judgement on the
acceptability of the residues. The report should be certified by an
authorized person of the agency or research institution carrying
out the field trial and must contained the following information.
(a) General information
 Pesticide (active ingredient and trade name);
 Formulation;
 Trial number and type (field, glasshouse);
 Commodity (crop, animal etc);
 Variety;
 Test locations (country and site);
 Soil characteristics, pH, physical and chemical
properties;
 Name(s) and signature(s) of the person(s)
responsible for the trial.
(b)
Application data for field trials.
 Crop planting or sowing date; & harvest date
 Plot plan, crop layout or cropping system;
 Plot size or number of plants per plot/unit area;
 Number of plots per treatment;
 Method of application and equipment;
 Number of applications and application dates;
 Application details (overall, banded or circle);
 Dose rate – weight of a.i. per hectare
(in kg or g a.i/ha)
- weight/volume of formulation/hectare
- applied dilution
 Climatic conditions during and after applications
preferably for the whole period of the trial;
 Other pesticides applied to the trial plot; and
 Growth stage at (last) treatment.
134
(c)
Sampling data
 Growth stage at sampling;
 Method of sampling;
 Sampled part(s);
 Number of units in sample, if relevant;
 Sample weight and preparation (trimming, washing
or other common practices in preparing the
commodity);
 Control and treated samples;
 Date of sampling with time interval between last
application and sampling;
 Storage conditions before transporting to laboratory
and
 Date shipped.
E.
RESIDUE ANALYSIS REPORT
Analysis of major metabolites should also be included. Data obtained
from surface striping are not acceptable except for crops where other data
on that crop have established that the total residues are in fact only
surface residues.
(a) Details on the method used.
 Full description or adequate reference;
 Apparatus;
 Chemicals and reagents;
 Data on selectivity of method;
 Data on limits of determination and quantification of
the method for the commodity in question;
 Adequate recovery data at levels corresponding to
those found in practice. The raw agricultural
commodity, or a macerate thereof, should be
fortified for the recovery tests, and not the crop
extracts. For data to be accepted, the % recovery
must be within the range of 70%-120%. The
recovery tests should be at levels corresponding to
those found in practice and actual analysis of
treated samples. Evidence on the workability,
reproducibility, selectivity and sensitivity of the
method must be submitted.
135


A statement on whether or not the results have
been corrected for blanks, recoveries or both.
In all cases, Good Laboratory Practices (GLP) or
International Standard Scheme Accreditation must
be adhered to.
(b)
Preparation of sample.
Peeling, chopping, washing, removing of soil, drying,
separation of oil or fat or juice, cooking, separation of
seed from the pulp, milling.
(c)
Presentation of data.
All analytical data obtained from the analysis of samples
should be provided, and not just a summary or an
average figure. It should be clearly stated how the
residues
are
calculated
and
expressed.
Chromatographic and/or spectrophotometric evidence to
support the analysis data must be submitted. Raw data
from the laboratory need not be submitted but must be
available on request.
REFERENCES
1.
Codex Alimentarius Commission Vol. 2 – Pesticides Residues in
Food, 1993.
2.
EPA Code of Federal Regulations, 40, Parts 150-189, 1986
3.
EPA Good Laboratory Practices Standards, Code of Federal
Regulations, 40, Part 160, 1990
4.
FAO/WHO Codex Alimentarius Commission Guidelines
Producing Residues Data for Supervised Trials, 1990 in 5 Parts
5.
FAO Manual on the Submission and Evaluation of Pesticide
Residues Data for the Estimation of Maximum residue Levels in
Food and Feed, 2009
on
136
6.
Official Journal of the European Communities, Vol. 4.89, 1989
7.
Principles for Identifying Unacceptable Pesticides, The Swedish
National Chemicals Inspectorate 1992
8.
Report on Short-term Consultancy by J.A.R. Bates to the
Malaysian-German Pesticide Project 1987
9.
United States Environment Protection Agency Pesticide
Assessment Guidelines, Sub-division O, Residue Chemistry
IMPORTANT NOTES
1.
THE COMMODITY GROUPS OF APPENDIX I MAY
CONTAIN THE NAMES OF ONLY THE MORE
IMPORTANT OR FAMILIAR COMMODITIES. IF A
COMMODITY IS NOT LISTED IN THE GROUP IT IS
SUPPOSED TO BE, REFER TO THE PESTICIDES
BOARD OR CODEX “INDEX OF FOOD AND ANIMAL
FEED COMMODITIES” TO DETERMINE THE
COMMODITY GROUP OF THAT COMMODITY.
2.
IN SOME GROUPS, ANY COMMODITY IN A GROUP
CAN REPRESENT ANOTHER COMMODITY IN THE
SAME
GROUP
IN
RESIDUE
TRIALS.
NOTWITHSTANDING THAT HOWEVER, IF THE
PESTICIDES BOARD IS OF THE OPINION THAT THE
RESIDUE TRIALS OF A COMMODITY DO NOT TRULY
REPRESENT THE EXPOSURE TO PESTICIDES OF
ANOTHER
COMMODITY
FOR
WHICH
THE
PESTICIDE IS RECOMMENDED, THEN RESIDUE
TRIALS OF THE SPECIFIC COMMODITY FOR WHICH
THE PESTICIDE IS RECOMMENDED WILL BE
REQUIRED.
137
APPENDIX I
INDEX OF CLASSES, TYPES AND GROUPS OF COMMODITIES
No. Group
CLASS
A
PRIMARY FOOD COMMODITIES OF PLANT ORIGIN
Type 1 : FRUITS
001 Citrus fruits
002 Pome fruits
003 Stone fruits
004 Berries and other small fruits
005 Assorted tropical and sub-tropical fruits-edible peel
006 Assorted tropical and sub-tropical fruits-inedible peel
Type 2 : VEGETABLES
009
010
011
012
013
014
015
016
017
Bulb vegetables
Brassica (cole or cabbage) vegetables,
Head cabbage, Flowerhead brassicas
Fruiting vegetables, Cucurbirs
Fruiting vegetables, other than cucurbits
Leady vegetables (including brassica leafy vegetables)
Legume vegetables
Pulses
Root and tuber vegetables
Stalk and stem vegetables
020
021
Cereal grains
Grasses for sugar or syrup production
Type 3 : GRASSES
Type 4 : NUTS AND SEEDS
022 Tree nuts
023 Oilseed
024 Seed for beverages and sweets
Type 5 : HERBS AND SPICES
027 Herbs
028 Spices
138
COMMODITY GROUPS
CLASS
A:
PRIMARY FOOD COMMODITIES OF PLANT ORIGIN
TYPE 1: FRUITS
Group No. 001 :
Citrus fruits
Citrus fruits are produced on trees or shrubs of the family Rutaceae. These fruits are
characterized by aromatic oily peels, globular forms and interior segments of juicefilled vesicles. The fruit is fully exposed to pesticides during the growing season.
Post-harvest treatments with pesticides and liquid waxes are often carried out to avoid
deterioration during transport and distribution due to fungal diseases, insect pests or
loss of moisture.
The fruit pulp may be consumed in succulent form and as a juice. The entire fruit may
be used for preserves.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity.
COMMON NAME
Lemon
Pomelo
Grapefruit
Musk lime /
Calamondin
Mandarin orange
LOCAL NAME/OTHER NAME
Lemon
Limau bali, limau besar, limau
tambun
Limau gedang
Limau kasturi
SCIENTIFIC NAME
Citrus limon
Citrus grandis / Citrus
maxima
Citrus paradise
Citrus mitis
Limau madu / limau langkat
Citrus suhuiensis, Citrus
reticulata
Citrus aurantifolia
Citrus hystrix
Lime
Limau nipis
Kaffir lime / Leech
Limau purut
lime
Representative Crop : Mandarin orange
139
Group No. 002 :
Pome fruits
Pome fruits are produced on trees and shrubs belonging to certain genera of the rose
family (Rosaceae), especially the genus Malus and Pyrus. They are characterized by
fleshy tissue surrounding a core consisting of parchment-like carpels enclosing the
seeds.
Pome fruits are fully exposed to pesticides applied during the growing season. Postharvest treatments directly after harvest may also occur. The entire fruit, except the
core, may be consumed in the succulent form or after processing.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removal of stems.
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Malus pumila
Apple
Epal
Pyrus communis L.
Pear
Pir
Representative crop : any of the group
Group No. 003 :
Stone fruits
Stone fruits are produced on trees belonging to the genus Prumus of the rose family
(Rosaceae). They are characterized by fleshy tissue surrounding a single hard-shelled
seed. The fruit is fully exposed to pesticides applied during the growing season (from
fruit setting until harvest). Dipping of fruit after harvest, especially with fungicides, may
also occur.
The entire fruit, except the seed, may be consumed in a succulent or processed form.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removal of stems and stones, but the residue calculated and
expressed on the whole commodity without stem.
COMMON NAME
LOCAL NAME/OTHER
NAME
Cherries
Ceri
Apricot
Apricot
Peach
Pic
Plum (including prunes)
Plum
Representative crop : any of the group
SCIENTIFIC NAME
Prunus avium
Prunus armeniaca L.
Prunus persica L.
Prunus Domestica L.
140
Group No. 004 :
Berries and other small fruits
Berries and other small fruits are derived from a variety of perennial plants and shrubs
having fruit characterized by a high surface: weight ratio. The fruits are fully exposed
to pesticides applied during the growing season (blossoming until harvest).
The entire fruit, often including seed, may be consumed in a succulent or processed
form.
Portion of the commodity to which the MRL applied (and which is analyzed): Whole
commodity after removal of cap and stems. Currants, Black, Red, White: fruit
with stem.
COMMON NAME
LOCAL NAME/OTHER
NAME
Grapes
Anggur
Strawberry
Strawberri
Representative crop : any of the group
SCIENTIFIC NAME
Vitis vinifera
Fragaria vesca
Group No. 005 :
Assorted tropical and sub-tropical fruits-edible peel
The assorted tropical and sub-tropical fruits-edible peel are derived from the immature
or mature fruits of a large variety of perennial plants, usually shrubs or trees. The fruits
are fully exposed to pesticides during the growing season. (period of fruit
development).
The whole fruit may be consumed in a succulent or processed form.
The Group 005 Miscellaneous fruits – edible peel is divided in 3 subgroups:
005 A Assorted tropical and sub tropical fruits – edible peel – small
005 B Assorted tropical and sub tropical fruits – edible peel – medium to large
005 C Assorted tropical and sub tropical fruits – edible peel – palms
Portion of the commodity to which the MRL applies (and which is analyzed):
Whole commodity. Dates and Olives: Whole commodity after removal of stems
and stones but residue calculated and expressed on the whole fruit.
005 A Assorted tropical and sub tropical fruits – edible peel – small
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Syzygium
Rose Apple/ Melaka jambu
Jambu bol
jambos/malaccense
Syzygium
Water apple
Jambu air
javanica/aqueum
Phyllanthus
acidus
Otaheite gooseberry
Cermai
Representative crop : any of the group
141
005 B Assorted tropical and sub tropical fruits – edible peel – medium to large
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Averrhoa segi carambola
Carambola
Starfruit, belimbing
Averrhao bilimbi
Bilimbi
Belimbing buluh
Psidium guajava
Guava
Jambu batu
Spondias dulcis
Ambarella
Kedondong
Sandoricum
koetjape
Sentul
Sentul
Representative crop: guava, carambola
005 C Assorted tropical and sub tropical fruits – edible peel – palms
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Phoenix dactylifera L.
Date
Kurma
Group No. 006 :
Assorted tropical and sub-tropical fruits-inedible peel
The assorted tropical and sub-tropical fruits-inedible peel are derived from the
immature or mature fruits of a large variety of perennial plants, usually shrubs or trees.
Fruits are fully exposed pesticides applied during the growing season (period of fruit
development) but the edible portion is protected by skin, peel or husk.
The edible part of the fruits may be consumed in a fresh or processed form.
The group Miscellaneous fruits – inedible peel is divided in 5-6 subgroups:
006 A Assorted tropical and sub-tropical fruits – inedible peel – small
006 B Assorted tropical and sub-tropical fruits – inedible smooth peel – large
006 C Assorted tropical and sub-tropical fruits – inedible rough or hairy peel – large
006 D Assorted tropical and sub-tropical fruits – inedible peel – cactus
006 E Assorted tropical and sub-tropical fruits – inedible peel – vines
006 F Assorted tropical and sub-tropical fruits – inedible peel – palms
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
fruit unless qualified: e.g., banana pulp. Pineapple after removal of crown.
Avocado, mangos and similar fruits with hard seeds: Whole commodity after
removal of stone but calculated on whole fruit.
006 A Assorted tropical and sub-tropical fruits – inedible peel – small
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Euphoria malaiensis
Cat’s eyes
Mata kucing, Longan
Litchi chinensis
Laici/ Litchi
Laici
Lansium domesticum
Dokong
Dokong
Lansium domesticum
Duku
Duku
Lansium domesticum
Duku langsat
Duku langsat
Lansium domesticum
Langsat
Langsat
Baccaurea motleyana
Rambai
Rambai
Representative crop : longan
142
006 B Assorted tropical and sub-tropical fruits – inedible smooth peel – large
COMMON NAME
LOCAL NAME/OTHER
NAME
Horse mango
Bacang
Kuini
Kuini
Mango
Mangga, mempelam, pauh
Plum mango/Gandaria
Kundang/kemior
Papaya
Betik
Banana
Pisang
Mangosteen
Manggis
Pomegranate
Delima
Avocado
Avokado
Representative crop : banana, papaya, mango
SCIENTIFIC NAME
Mangifera foetida
Mangifera odorata
Mangifera indica
Bouea macrophylla
Carica papaya
Musa sapientum
Garcinia mangostana
Punica granatum
Persea americana
006 C Assorted tropical and sub-tropical fruits –inedible rough or hairy peel–
large
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Artocarpus integer
Chempedak
Cempedak
Artocarpus heterophyllus
Jack fruit
Nangka
Artocarpus altilis
Bread fruit
Sukun
Ananas comosus
Pineapple
Nenas
Durio zibethinus
Durian
Durian
Annona squamosa
Custard apple
Anona
Annona muricata
Soursop
Durian belanda
Annona reticulate
Bullock’s heart
Nona kapri
Nephelium lappaceum
Rambutan
Rambutan
Nephelium mutabile
Pulasan
Pulasan
Manilkara zapota
Chiku
Ciku, sapodilla
Representative crop : pineapple
006 D Assorted tropical and sub-tropical fruits – inedible peel – cactus
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Hylocereus undatus
Dragon fruit
Buah mata naga
006 E Assorted tropical and sub-tropical fruits – inedible peel – vines
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Passiflora edulis
Passion fruit
Markisa
Actinidia deliciosa
Kiwi fruit
Kiwi
Representative crop : any of the group
143
006 F Assorted tropical and sub-tropical fruits – inedible peel – palms
COMMON NAME
LOCAL NAME/OTHER
SCIENTIFIC NAME
NAME
Salacca edulis
Snakeskin fruit
Salak
Cocus nucifera L.
Coconut, Young
Kelapa
Representative crop : any of the group
TYPE 2: VEGETABLES
Group No. 009 :
Bulb vegetables
Bulb vegetables are pungent highly flavoured foods derived from fleshy scale bulbs in
some commodities (including stem and leaves), of the genus Allium of the lily family
(Liliaceae). Bulb fennel is included in this group; the bulb-like growth of this commodity
gives rise to similar residues.
The subterranean parts of the bulbs and shoots are protected from direct exposure to
pesticides during the growing season.
The entire bulb may be consumed after removal of the parchment-like skin. The
leaves and stems of some species or cultivars may also be consumed.
Bulb onions are bulb vegetables with mature bulbs. The entire bulb may be consumed
after removal of the parchment-like skin.
Green onions are bulb vegetables with immature bulbs. Immature bulbs amy be
consumed and also leaves and stems of some species of cultivars may also be
consumed.
009A Bulb onions : mature bulbs (dry)
009B Green onions : immature bulbs including leaves stems and flowers.
Portion of the commodity to which the MRL applies (and which is analyzed):
Bulb/dry onions and garlic: Whole commodity after removal of roots and
adhering soil and whatever parchment skin is easily detached. Leeks and spring
onions: Whole vegetable after removal of roots and adhering soil.
009A Bulb onions : mature bulbs (dry)
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Garlic
Bawang putih
Allium sativum
Onion
Bawang besar
Allium cepa
Shallot
Bawang merah
Allium cepa
Representative crop : any of the group
144
009B Green onions : immature bulbs including leaves stems and flowers.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Chives/ Spring
onion
Daun bawang
Allium schoenoprasum
Chinese chives
Kucai
Apium odorum
Leek
Bawang sayuran
Allium ampeloprasum
Representative crop : any of the group
Group No. 010 :
Brassica (cole or cabbage) vegetables, Head cabbages,
Flowerhead brassicas
Brassica (cole or cabbage) vegetables and flowerhead brassicas are foods derived
from the leafy heads, stems and immature inflorescences of plants belonging to the
genus Brassica of the family Crucifera. Although Kohlrabi does not fully comply with
the description above, for convenience and because of the similarity in residue
behaviour, the commodity is classified in this group. Kohlrabi has a tuber-like
enlargement of the stem.
The edible part of the crop is partly protected from pesticides applied during the
growing season by outer leaves, or skin (Kohlrabi).
The entire vegetable after discarding obviously decomposed or whitered leaves may
be consumed.
010A Flowerhead Brassicas
010B Head Brassicas
010C Stem Brassicas
Portion of the commodity to which the MRL applies (and is analyzed): Head
cabbages and Kohlrabi: Whole commodity as marketed, after removal of
obviously decomposed or withered leaves. Cauliflower and broccoli: flower
heads (immature inflorescence only). Brussels sprouts: “buttons” only.
145
010A Flowerhead Brassicas
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Broccoli
Bunga brokoli
Brassica oleracea var. botrytis
Cauliflower
Kubis bunga
Brassica oleracea var. cauliflora
LOCAL NAME/
SCIENTIFIC NAME
Representative crop : broccoli
010B Head Brassicas
COMMON NAME
OTHER NAME
Brassica oleracea L.var. capitata
Cabbages, head
Kubis bulat
L.
Chinese cabbage
Kubis cina, wong nga pak
Brassica chinensis
Brassica oleracea L.var.
Brussels sprouts
gemmifera
Representative crop : cabbage
Group No. 011 :
Fruiting vegetables, Cucurbits
Fruiting vegetables, Cucurbits are derived from the immature fruits of various plants,
belonging to the botanical family Cucurbitaceae; usually these are annual vines or
bushes.
These vegetables are fully exposed to pesticides during the period of fruit
development.
The edible portion of these fruits of which the inedible peel is discarded before
consumption is protected from most pesticides, by the skin or peel, except from
pesticides with a systemic action.
The entire fruiting vegetable or the edible portion after discarding the inedible peel
may be consumed in the fresh form or after processing. The entire immature fruit of
some of the fruiting vegetable species may be consumed, where as only the edible
portion of the mature fruit of the same species, after discarding the then inedible peel,
is consumed.
146
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removal of stems.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Angled loofah
Ketola, petola
Luffa acutangula
Bitter gourd
Peria
Momordica charantia
Cucumber
Timun
Cucumis sativus
Gherkin
Timun kecil
Cucumis sativus
Snake gourd
Ketola ular, petola ular
Trichosanthes anguina
Wax gourd
Kundor, winter melon
Benincasa hispida
Bottle gourd
Labu air
Lagenaria siceraria
Chayote
Labu siam
Sechium edule
Pumpkin
Labu manis
Cucurbita moschata
Squash
Labu
Cucurbita maxima
Zucchini
Zucchini
Cucurbita pepo
Melon (various
Honey dew melon,
varieties and
muskmelon, rock melon,
cultivars)
kantalop
Cucumis melo
Watermelon
Tembikai
Citrullus lanatus
Representative crop: cucumber, pumpkin, watermelon
Group No. 012 :
Fruiting vegetables, other than Cucurbits
Fruiting vegetables, other than Cucurbits are derived from the immature and mature
fruits of various plants, usually annual vines and bushes. The group includes edible
fungi and mushrooms, being comparable organs of lower plants. Many plants of this
group belong to the botanical family Solanaceae.
This group does not include fruits of vegetables of the botanical family Cucurbitaceae
or the pods of vegetables of the Leguminosae family.
The vegetables of this group are fully exposed to pesticides applied during the period
of fruit development, except those of which the edible portions are covered by husks,
such as sweet corn and ground cherries (Physalis spp.). The latter fruiting vegetables
are protected from most pesticides by the husk except from pesticides with a systemic
action.
147
The entire fruiting vegetable or the edible portion after discarding husks or peels may
be consumed in a fresh from or after processing.
Three subgroups are defined:
012A Tomatoes
012B Pepper and pepper-like commodities
012C Eggplant and eggplant-like commodities
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removal of stems. Mushrooms: Whole commodity. Sweet corn
and fresh corn: kernels plus cob without husk.
012A Tomatoes
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Tomato (various
varieties and
cultivars)
Tomato
Lycopersium esculentum
012B Pepper and pepper-like commodities
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Capsicum
Lada besar, sweet pepper,
Capsicum annum grossum
Cili besar, bell pepper var.
Capsicum annum var.
Chilli
Cili, cabai, lada
acuminatum
Lady's finger
Okra, bendi
Abelmoschus esculentus
Roselle
Roselle
Hibiscus sabdariffa
Bird Chilli pepper
Cili burung
Capsicum Frutescens
Representative crop : chilli, capsicum
148
012C Eggplant and eggplant-like commodities
LOCAL NAME/
COMMON NAME
SCIENTIFIC NAME
OTHER NAME
Brinjal(various
varieties and
cultivars)
Eggplant, terung, aubergines
Solanum melongena
Group No. 013 :
Leafy vegetables (including Brassica leafy vegetables)
Leafy vegetables are foods derived from the leaves of a wide variety of edible plants,
usually annuals or biennials. They are characterized by a high surface to weight ratio.
The leaves are fully exposed to pesticides applied during the growing season.
The entire leaf may be consumed, either fresh or after processing or household
cooking.
013A Leafy greens
013B Brassica Leafy vegetables
013C Leaves of root and tuber vegetables
013D Leaves of trees, shrubs and vines
013E Leafy aquatic vegetables
013F Witloof
013G Leaves of Cucurbitaceae
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity as usually marketed, after removal of obviously decomposed or
withered leaves.
013A Leafy greens
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Bayam merah, chinese
Amaranth
spinach
Amaranthus gangeticus
Ceylon spinach
Remayong
Basella rubra
Chinese box thorn
Kau kei
Lycium chinese
Fern shoots
Pucuk paku
Athrium esculentum
Chrysanthemum coronarium
Garland
chrysanthemum
Tong ho
var.spatiosum
Lettuce
Salad bulat, salad
Lactuca sativa
Spinach
Por choy
Spinacia oleracea
149
You mak, sayur minyak,
Indian lettuce
sawi rana
Lactuca indica
Kesum
Kesum
Polygonum minus
Sirih
Sirih
Piper betle
Sweet shoot
Cekor manis, asin-asin
Sauropus androgynus
Meranti leaves
Pucuk meranti
Shorea spp., Parashorea spp.
Representative crop : lettuce, spinach
013B Brassica Leafy vegetables
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Kailan
Brassica alboglabra
Sawi, sawi bunga/caixin,
Brassica chinensis var.
Leaf mustard
choy sum
parachinensis
Green mustard,
Indian mustard/ sawi pahit/
Kale
Chai sim, kai choy
Brassica juncea
Sawi jepun/xiao baicai,
Hybrid mustard
sawi hybrid
Brassica chinensis
Brassica chinensis var.
White mustard
Pak choy, sawi putih
chinensis
Representative crop : mustard, kale
013C Leaves of root and tuber vegetables
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Cassava leaves
Pucuk ubi
Manihot esculenta
Yam leaves
Daun keladi
Discorea spp.
Representative crop : any of the group
150
013D Leaves of trees, shrubs and vines
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Daun betik
Carica papaya L.
LOCAL NAME/
SCIENTIFIC NAME
Papaya leaves
013E Leafy aquatic vegetables
COMMON NAME
OTHER NAME
Water cress
Semanggi/selada air
Nasturtium officinale
Kangkung
Kangkung
Ipomoea aquatic
Representative crop : any of the group
Group No. 014 :
Legume vegetables
Legume vegetables are derived from the succulent seed and immature pods of
leguminous plants commonly known as beans and peas.
Pods are fully exposed to pesticides during the growing season, whereas the
succulent seed is protected within the pod from most pesticides, except pesticides
with systemic action.
The succulent forms may be consumed as whole pods or as the shelled product.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity, unless otherwise specified.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Kacang serinding, lima bean
Phaseolus lunatus
winged bean
Kacang botol, kacang kelisa
Psophocarpus tetragonolobus
French bean
Kacang buncis
Phaseolus vulgaris
Long bean
Kacang panjang
Vigna sinensis
Snow pea
Sweet peas, kacang wangi
Pisum sativum
Butter bean
Four-angled bean,
Representative crop : Long bean, French bean
151
Group No. 015 :
Pulses
Pulses are derived from the mature seeds, naturally or artificially dried, of leguminous
plants known as beans (dry) and peas (dry).
The seeds in the pods are protected from most pesticides applied during the growing
season except pesticides with systemic action. The dried beans and peas are often
exposed to post-harvest treatments.
The dry pulses are consumed after processing or household cooking.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Chick pea (dry)
Kacang kuda
Cicer arietinum
Kacang hijau/ mung bean
Green gram (dry)
(dry)
Phaseolus aureus Roxb
Red bean
Kacang sepalit
Phaseolus calcaratus
Sword bean
Kacang parang
Canavalia gladiate
Lima bean
Kacang serinding
Phaseolus lunatus
Lentil (dry)
Kacang dal
Lens esculenta
Cowpea
Kacang bol
Vigna unguiculata
Black gram
Kacang hitam
Phaseolus mungo
Groundnut
Kacang tanah
Arachis hypogaea
Soy bean
Kacang soya
Glycine max
Representative crop : any of the group
Group No. 016 :
Root and tuber vegetables
Root and tuber vegetables are the starchy enlarged solid roots, tubers, corms or
rhizomes, mostly subterranean, of various species of plants, mainly annuals.
The underground location protects the edible portion from pesticides applied to the
aerial parts of the crop during the growing season; however, the commodities in this
group are exposed to pesticide residues from soil treatments.
The entire vegetable may be consumed in the from of fresh or processed foods.
152
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removing tops. Remove adhering soil (e.g. by rinsing in
running water or by gentle brushing of the dry commodity)
LOCAL NAME/
COMMON NAME
OTHER NAME
SCIENTIFIC NAME
Arrow-root
Ubi garut
Marania arundinacea
Beet root
Ubi bit
Beta vulgaris
Carrot
Lobak merah, karot
Daucus carota
Ginger
Halia
Zingiber officinale
Lotus root
Leen gnow
Nelumbo nucifera
Tumeric
Kunyit
Curcuma longa
Radish
Lobak putih
Raphanus sativus
Galangal rhizome
Lengkuas
Kaempferia galanga
Tapioca
Cassava, ubi kayu
Manihot esculenta
Water chestnut
Ma'tai
Eleocharis dulcis
Yam
Ubi keladi, taro
Colocasia esculenta
Potato
Ubi kentang
Solanum tuberosum
Sweet potato
Keledek
Ipomoea batatas
Sengkuang, local
Pachyrrhizua erosus
Yam bean/ sweet
turnip
Representative crop : carrot, potato
Group No. 017 :
Stalk and stem vegetables
Stalk and stem vegetables are the edible stalks, leaf stems or immature shoots from
a variety of annual or perennial plants. Although not actually belonging to this group,
globe artichoke (the immature flowerhead) of the family Compositae is included in this
group.
Depending upon the part of the crop used for consumption and the growing practices,
stalk and stem vegetables are exposed, in varying degrees, to pesticides applied
during the growing season.
Stalk and stem vegetables may be consumed in whole or in part and in the form of
fresh, dried or processed foods.
153
Portion of the commodity to which the
MRL applies (and which is analyzed):
Whole commodity as marketed after removal of obviously decomposed or
withered leaves. Rhubarb, leaf stems only; globe artichoke, flowerheads only;
celery and asparagus, remove adhering soil.
LOCAL NAME/
COMMON NAME
OTHER NAME
SCIENTIFIC NAME
Artichokes
Articok
Cynaria scolymus
Asparagus
Lo shun
Asparagus officinalis
Yam stalk
Batang keladi
Colocasia esculenta
Bean sprouts
Taugeh
Phaseolus aureus
Celery(stem)
Saderi
Apium graveolens
Lemongrass
Batang Serai
Cymbopogen citratus
Bamboo shoots
Pucuk rebung
Bambusa vulgaris
Representative crop : celery
154
TYPE 3: GRASSES
Group No. 020 :
Cereal grains
Cereal grains are derived from the ears (heads) of starchy seeds produced by a
variety of plants, primarily of the grass family (Gramineae).
The edible seeds are protected to varying degrees from pesticides applied during the
growing season by husks. Husks are removed before processing and/ or
consumption.
Cereal grains are often exposed to post-harvest treatments with pesticides:
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity.
COMMON NAME
Corn / maize
LOCAL NAME OTHER
NAME
Jagung
SCIENTIFIC NAME
Zea mays
Group No. 021 :
Grasses for sugar or syrup production
Grasses for sugar or syrup production, includes species of grasses with high sugar
content especially in the stem. The stems are mainly used for sugar or syrup
production, and to a small extent as vegetables or sweets. The leaves, ears and
several wastes of the sugar or syrup manufacturing process are used, among others,
as animal feed.
The stems are exposed to pesticides during the growth stage and from pesticides
applied for soil treatment.
Portion of the commodity to which the MRL applies (and which is analyzed): The stem
only.
COMMON NAME
Sugar cane
LOCAL NAME OTHER
NAME
Tebu
SCIENTIFIC NAME
Saccharum officinarum
155
TYPE 4: NUTS AND SEEDS
Group No. 022 :
The Nuts
Tree nuts are the seeds of a variety of trees and shrubs which are characterized by a
hard inedible shell enclosing an oily seed.
The seed is protected from pesticides applied during the growing season by the shell
and other parts of the fruit.
The edible portion of the nut is consumed in succulent, dried or processed form.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity after removal of shell. Chestnuts: whole in skin.
COMMON NAME
LOCAL NAME/OTHER
NAME
Cashew nut
Biji Gajus
Chestnuts
Buah berangan
Representative crop : any of the group
SCIENTIFIC NAME
Anacardium occidentale
Castanea sativa
Group No. 023 :
Oilseed
Oilseed consists of seeds from a variety of plants used in the production of edible
vegetable oils, seed meals and cakes for animal feed. Some important vegetable oil
seeds are by-productions of fibre or fruit crops (e.g. cotton seed, olives).
Some of the oilseeds are, directly or after slight processing (e.g. roasting), used as
food (e.g. peanuts) or for food flavouring (e.g. poppy seed, sesame seed).
Oilseeds are protected from pesticides applied during the growing season by the shell
or husk.
Portion of the commodity to which the MRL applies (and which is analyzed): Unless
specified, seed or kernels, after removal of shell or husk.
COMMON NAME
LOCAL NAME/OTHER
NAME
Mustard seeds
Biji sawi
Coconut
Kelapa
Peanut/ground nut
Kacang tanah
Representative crop : any of the group
SCIENTIFIC NAME
Brassica nigra
Cocos nucifera
Arachis hypogaea
Group No. 024 :
Seed for beverages and sweets
The seed for beverages and sweets are derived from tropical and sub-tropical trees
and shrubs. After processing, the seeds are used in the production of beverages and
sweets.
These seed are protected from pesticides applied during the growing season by the
shell or other parts of the fruit
156
Portion of the commodity to which the MRL applies (and which is analyzed): Unless
specified, whole commodity (seed only, other parts of the fruit not included).
COMMON NAME
Coffee beans
LOCAL NAME/OTHER
NAME
Biji kopi
SCIENTIFIC NAME
Coffea arabica
157
TYPE 5: HERBS AND SPICES
Group No. 027 :
Herbs
Herbs consist of leaves, flowers, stems and roots from a variety of herbaceous plants,
used in relatively small amounts as condiments to flavour foods or beverages. They
are used either in fresh or naturally dried form.
Herbs are fully exposed to pesticides applied during the growing season. Post-harvest
treatments are often carried out on dried herbs.
Herbs are consumed as components of other foods in succulent and dried forms or as
extracts of the succulent products.
Portion of the commodity to which the MRL applies (and which is analyzed): Whole
commodity as prepared for wholesale or retail distribution.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Daun ketumbar, chinese
Coriander leaves
parsley
Coriandrum sativum
Murraya koenigii Spreng.
Curry leaves
Daun kari
Chalcas koenigii
Pandan leaf
Pandan
Pandanus amaryllifolius
Indian pennywort
Pegaga
Hydrocotyle asiatica
Parsley
Parsli
Petroselinum crispum
Lemongrass
Daun Serai
Cymbopogen citratus
Stevia
Daun stevia
Stevia rebaudiana (Bertoni)
Representative crop : any of the group
Group No. 028 :
Spices
Spices consists of the aromatic seeds, root, berries or other fruits from a variety of
plants, which are used in relatively small quantities to flavour foods.
Spices are exposed in varying degrees to pesticides applied during the growing
season. Also, post-harvest treatments may be applied to spices in the dried form.
They are consumed primarily in the dried form as condiments.
158
Portion of the commodity to which the MRL applies (and which is analyzed): Unless
specified, whole commodity as marketed, mainly in the dried form.
COMMON NAME
LOCAL NAME/
SCIENTIFIC NAME
OTHER NAME
Black pepper
Lada hitam
Piper nigrum
Cumin, black
Jintan hitam
Bunium persicum
Cumin seed
Jintan putih
Cuminum cyminum L.
Star anise
Bunga lawang
Illicium verum Hook. f
Cinnamon bark
Kayu manis
Cinnamon verum
Representative crop : any of the group
159
APPENDIX II
REPORTING PROTOCOL FOR PESTICIDE RESIDUE TRIALS
__________________________________________________________
RESIDUE TRIAL ON PADDY
1.
Objective :
To determine whether residues of the pesticide and its
major metabolite(s) (if applicable) are present in various
fractions of paddy after several treatments with the
pesticide per season.
2.
Product used :
State trade name, % w/w concentration of active
ingredients and formulation
3.
Test crop and variety must be stated
4.
Location and number of trials: At least three (3) trials must be conducted at
different locations with different soil conditions – state soil
characteristics, PH, physical and chemical properties. 1
trial must be done in Malaysia.
The trials cannot be considered independent if they are
carried out at the same location within a growing season.
State paddy crop seasons. Paddy planting date and
harvest date.
5.
Crop seasons:
6.
Field design:
Number of plot. Plot size – suggested minimum size plot –
5m x 5m. Replication within the plot is not necessary.
7.
Treatment :
control (no treatment
recommended rate
8.
Pesticide application: equipment and method of application, date and number
of
applications, interval between applications, spray
volume, stage of crop growth during the applications,
other pesticide used, climatic conditions during and after
application but preferably during whole period of trial.
9.
Sampling:
with
test
pesticide)
&
at
Random sampling. Begin with control plot followed by plot
with the lowest rate to the highest rate in the trial.
Dates of sampling: for herbicide where the application is at early stage –
sampling at actual harvest only
For other than herbicide - sampling at several different days after last treatment
for example: 0,7,14, 30 days after last treatment
Size of sample and sample parts: 1 kg of unpolished rice grain, 1 kg of polished
rice grain, 500 g paddy straw and 500 g husk from each plot.
Storage condition before shipment, date shipped and method of samples
packaging –sampling to shipment period must be within 24-36 hours.
160
10.
Method of analysis:
Detailed method of sample preparation and method
used to analyse the sample, with laboratory evidence to
support claims on the limits of detection, recovery at
various concentrations, reproducibility of recovery and
results obtained. State the reference method of analysis.
Storage temperature and period of samples stored before
the analysis. Storage stability study must be provided.
Name of personnel involved in pesticide residue analytical
phase. GLP or ISO laboratory certificate.
11.
Results and interpretation: The analytical results of every sample should be
clearly tabulated. This part should include the
interpretation of the results and the justification for the
proposals on MRL and PHI.
12.
Studies on livestock: data must show the level of residues that will result in
the meat (muscle, liver, kidney and fat), poultry (muscle,
liver and fat), eggs and milk.
13.
Processing studies : information on the reduction or concentration of residues
due to post-harvest processing or household cooking
161
APPENDIX III
LIST OF RESIDUE DATA EXEMPTION
Pesticide registration for the purpose of industry, public health, household, technical
concentration, veterinary and agriculture commodity which is not food crop ex:
ornamental do not require residue data.
Generally, the registrant/applicant has to submit residue data for the registration of a
proprietary pesticide, or commodity pesticide with new recommendations intended to
be used on an agricultural food commodity. Below are some cases where the
submission of residue data is exempted for registration purposes.
1The pesticide is applied for/at:
 Seed treatment
 Seedling stage
 Preplanting stage
23-
Any application of pesticide on oil palm plant below 2 years
Any application of pesticide on crop before flowering stage, except for systemic
pesticide – evidence must be submitted to show that the application of the
pesticide is required only before the flowering stage of the crop proposed
4Any application of rodenticide in bait formulation
Application for residue data exemption other than cases listed above, full explanation/
justification on why the pesticide residue data should be exempted for registration
purpose need to be submitted to the Pesticide Board.
*If the Pesticide Board is of the opinion that the residue data is exempted for
registration purposes, then the submission of residue data will be required although it
is listed as above.
162
CHECKLIST ON RESIDUE DATA REQUIREMENT
 Definitions of the residue relevant to Maximum Residue Limits (MRLs).
_______________________________________________________________
_______________________________________________________________
 Detailed reports on supervised residue trial on recommended crops based on
accepted protocols. At least three field experiments done at different sites must
be submitted.
_______________________________________________________________
_______________________________________________________________
 Residue analytical method with chromatograms for standard, control, sample
and recovery test.
_______________________________________________________________
_______________________________________________________________
 Information on metabolism or degradation of the active ingredient in crops or
plants.
_______________________________________________________________
_______________________________________________________________
 Acceptable Daily Intake (ADI) of the pesticide in mg/kg body weight.
_______________________________________________________________
_______________________________________________________________
 Proposed Pre-harvest Interval (PHI) or Pre-slaughter Interval (PSI).
_______________________________________________________________
_______________________________________________________________
 Proposed Maximum Residue Limits (MRLs) calculated based on Dietary Risk
assessment of the pesticide.
_______________________________________________________________
_______________________________________________________________
 Maximum Residue Limits (MRLs) from other countries that have registered the
pesticide.
_______________________________________________________________
_______________________________________________________________
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