Food Regulations Malaysia

MINISTRY OF HEALTH MALAYSIA
GENERAL FORMAT FOR THE APPLICATION ON AMENDMENT OF FOOD REGULATIONS 1985 - 1

_________________________________________________________________________________
State the purpose of application whether it is:
An application of standards of a new food item which is not yet regulated;

An application to amend standard(s) of food which is already regulated;
Guide for application:

i)
ii)
iii)
iv)
v)
vi)
vii)
Section A in this format must be completed.

Based on the purpose of application, complete only relevant section, either section B or C.
Where application is for the use of food additive which is not yet approved, FORMAT FOR
THE APPLICATION FOR THE USE OF A FOOD ADDITIVE should be used.
Where relevant, provide summaries of information required so as to assist the Committee
members in understanding the application.
Submit copies of all references cited in the text as appendices.
All information requested in this format must be submitted in Bahasa Malaysia or English.
Ten (10) copies of this format must be submitted together with the necessary supporting
document.
Application should be addressed to:

The Secretary,
The Food Regulations 1985 Technical Advisory Committee
Food Safety and Quality Division
Ministry of Health
Aras 3, Blok E7, Parcel E
Pusat Pentadbiran Kerajaan Persekutuan
62590 PUTRAJAYA
(Attn.: Ms. Nik Shabnam bt. Nik Mohd. Salleh / Ms. Roziaton bt. Abdul Wahab)
Tel. No.: 03-8883 3888
Fax. No.: 03-8889 3815
E-mail: [email protected] or [email protected]
SECTION A
1.
Name of applicant (in full and in block letters)*:
2.
Business address:
3.
Mailing address:
4.
E-mail address:
5.
Telephone No.:
6.
Type of business:
Fax No.:
*State:
a)
whether applicant is a manufacturer or its agent;
b)
whether this application is on behalf of a single firm or organization;
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c)
whether this application is on behalf of food processing industry or other firms or

organisations;
d)
if on behalf of the food processing or other industries or organisations, names and

addresses of these.
SECTION B
For the application of standards of a new food item, state/provide:
1.
common name of the proposed item (N.B. trade names are not acceptable);
2.
category of the proposed item under Food Regulations 1985 and give reason;
3.
description/definition of the proposed item including the product specification (e.g., brix, Aw, pH,
salt content, total solid, shelf life, storage condition before and after opening of package, etc.);
4.
lists of ingredients, food additives and processing aids that are going to be added or/and used
in the proposed item together with the percentage of use, technological function, proposed
minimum and maximum levels of use and source of origin (plant or animal) of each ingredient,
food additive and processing aid;
5.
the target consumer and the suitability of the proposed item whether it is for general public,
infants, children, elderly etc;
6.
safety assessment i.e. physical, chemical and microbiological data including shelf life study of
the item;
7.
regulation/standard/approval of the proposed item by other countries or recognized

international agencies and state to your knowledge if approval has been rejected by any
statutory body or authority (provide the actual copies of regulation/standard/approval as
appendices);
8.
advantage(s) or benefit to the consumer from the use of the proposed item;
9.
scientific justification on the advantage(s) or benefit of the proposed item;
10.
research or toxicological study on the adverse effect related to the added ingredients, food
additives and processing aids. (Provide a summary of the pharmacological and toxicological
information including a summary and bibliography of pertinent literature);
11.
the outline of the method of manufacturing of the proposed item including critical processing
parameters;
12.
analytical controls used during various stages of the manufacturing, processing and packing of
the proposed item;
13.
analytical method to determine all the relevant physical, chemical, microbiological and sensory
attributes/specification of the food;
14.
other relevant information.
Page 2 of 4
SECTION C
For the application to amend standard of food which is already regulated, state/provide:
1.
classification of the food under Food Regulations 1985 (state the regulation number);
2.
description/definition of the food including the product specification (e.g., brix, Aw, pH, salt
content, total solid, shelf life, storage condition before and after opening, etc.);
3.
list of ingredients, food additives and processing aids that is used in the food together with the
percentage of use, technological function, minimum and maximum levels of use and source of
origin (plant or animal) of each ingredient, food additive and processing aid;
4.
the target consumer and the suitability of the food whether it is for general public, infants,
children, elderly etc;
5.
safety assessment i.e. physical, chemical and microbiological data including shelf life study of
the food;
6.
the proposed amendment of the standard;
7.
scientific justification of the amendment;
8.
regulation/standard/approval of this new standard by other countries or recognized international

agencies and state to your knowledge if approval has been rejected by any statutory body or
authority (provide the actual copies of regulation/standard/approval as appendices);
9.
advantage(s) or benefit to the consumer from the amendment of this standard;
10.
scientific justification on the advantage(s) or benefit from the amendment of this standard;
11.
the outline of the method of manufacturing of the food including critical processing parameters
and new processing methods;
12.
analytical controls used during various stages of the manufacturing, processing and packing of
the food;
13.
analytical method to determine all the relevant physical, chemical, microbiological and sensory
attributes/specification;
For the application to amend the standard by adding other ingredient / food additive into food
which is already regulated, state/provide additional information as below:
14.
chemical and/or common name of the proposed ingredient / food additive (N.B. trade names
are not acceptable) and source of origin (plant or animal),
15.
technological function of the proposed ingredient / food additive in the food;
16.
proposed minimum and maximum levels of use of the proposed ingredient / food additive in the
food;
17.
purpose of adding the proposed ingredient / food additive into the food. Show evidence that
the item will have the intended physical or technical results when added into the food;
18.
information regarding the stability and persistence of the proposed ingredient / food additive in
the food (if any);
19.
evidence as to whether or not the same objective can be obtained by good manufacturing
practises;
Page 3 of 4
20.
limit of the probable daily intake / acceptable daily intake of proposed ingredient / food additive
in the diet (if any);
21.
research or toxicological study on the adverse effect related to the proposed ingredient / food
additive (if any). (Provide a summary of the pharmacological and toxicological information
including a summary and bibliography of pertinent literature);
22.
the analytical method to determine the amount of the proposed ingredient / food additive in the
raw, processed and/or finished food1;
23.
the analytical method to determine any substance formed in or such food because of the use of
the proposed ingredient / food additive (if any)1;
24.
other relevant information.
Note:
i)
The methods should be both accurate and specific, specific here means that the item
can be differentiated from all other compounds (including substances which may be
used in place of the item) or constituents which are present in the food containing the
item;
ii)
These methods must be such that they can be applied with consistent results by
suitably equipped laboratory and trained personnel and should, where possible, be
such that they can be used for food regulatory control.
Declaration:
I (full name), identity card / passport number

. hereby declare:
a)
that this application is made by myself on behalf of
b)
that all particulars given in this form including all appendices attached are true and
correct to the best of my knowledge and belief and that no information has been
withheld which might prejudice this application.
Signature:
Name (capital letter):
Designation:
Official stamp:
Date:
RAW 05\General format amendment FR 2005
Page 4 of 4

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MINISTRY OF HEALTH MALAYSIA

GENERAL FORMAT FOR THE APPLICATION ON AMENDMENT OF FOOD REGULATIONS 1985 - 1

An application of standards of a new food item which is not yet regulated;

Guide for application:

Section A in this format must be completed.

Application should be addressed to:

Name of applicant (in full and in block letters)*:

whether applicant is a manufacturer or its agent;

whether this application is on behalf of a single firm or organization;

whether this application is on behalf of food processing industry or other firms or

if on behalf of the food processing or other industries or organisations, names and

regulation/standard/approval of the proposed item by other countries or recognized

scientific justification on the advantage(s) or benefit of the proposed item;

other relevant information.

the proposed amendment of the standard;

scientific justification of the amendment;

regulation/standard/approval of this new standard by other countries or recognized international

advantage(s) or benefit to the consumer from the amendment of this standard;

technological function of the proposed ingredient / food additive in the food;

other relevant information.

I (full name), identity card / passport number

that this application is made by myself on behalf of

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