Food Compliance
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Malaysia Food Additive Legislative Framework
Feb 08, 2020
Summer Jiang
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In Malaysia, the supervision philosophy of food additive is mostly consistent with standards and principles of international organizations such as FAO, WHO and the Codex Alimentarius. Food Act 1983 and the Food Regulations 1985 of Malaysia is the backbone of food legislation governing various aspects of food safety and quality control. The Food Safety and Quality Division (FSQD) of the Ministry of Health (MOH) is charged with the implementation and enforcement of the law.

1. Competent Authority

FSQD is the most important authority who implements an active food safety program which includes routine compliance, sampling, food premises inspection, food import control activity and licensing of specified food substances required under Food Act 1983 and Food Regulations 1985. It also conducts a food monitoring activity on specific food contaminants and additives. As a preventive approach, the FSQD have been implementing a food handlers training program, vetting of food labels, giving advice to the industry and consumers, and food safety certification scheme such Health Certificate, HACCP certification and Free Sale Certificate. New food additives or the expansion of food additive usage scope will be reviewed by technical committee under FSQD.

Another significant authority is the Ministry of Science, Technology and Innovation (MOSTI), who is responsible for developing and promoting food standards.

2. Relevant Regulations

2.1 Food Act 1983

The Food Act 1983 is the fundamental legislation of Malaysian food safety program. The objective is to protect the public against health hazards and fraud in the preparation, sale, and use of food. The Act is divided into five parts:
1)  preliminary matters, definitions of basic concepts;
2)  administration and enforcement of the act;
3)  protection of consumers against unsafety food in respect of composition, false labelling and misleading advertisement;
4)  importation, warranties and defenses;
5)  miscellaneous provisions.

2.2 Food Regulations 1985

The Food Regulations 1985 is the key supporting regulation for food safety covering procedures for taking samples, labelling, food additives and nutrient supplement, food packaging, and incidental constituent, additionally, food standards and particular labelling requirements for more than 380 food items. The main legal basis for regulation of food additives is found in Part 5, Subregulation 19 of the Food Regulations 1985 regulating permitted food additives that may be added to foods and the maximum permitted levels. Amendments of Food Regulations 1985 is very frequent. All amendments are published in Gazette, and the latest amendment Food Regulations (Amendment) (NO. 2) 2016 PU (A) 227 was established on August 26, 2016 and will come into force on 1 September 2016. 

Basic principles of food additive application provided by the regulation:
1) Substances that are not permitted as food additives cannot be used as foods additives;
2) Addition of food additives to foods should comply with standards prescribed under the food regulation with permitted food scope and maximum using levels;
3) Food additive should not be used to conceal any damage to, or any inferiority in the quality of that food.

2.3 Food Standards

Food standards in Malaysia are developed by Industry Standardization Committee under MOSTI. In general, the whole standard system was built on the basis of standards and principles of International Standardization Organization (ISO), Codex Alimentarius and International Accreditation Forum. There are two types of standards including national standards for all industries coded as MS (short for Malaysia Standards) + numbers, and equivalent international standards which coded as MS+ international standard code. It is notable that standards in Malaysia are basically voluntary standards except those cited by regulations are mandatory. A certified mark can be labeled by obtaining official certification.

3. Definition 

Food additives in Malaysia are defined by Food Regulations 1985 as:

“Food additive” means any safe substance that is intentionally introduced into or on a food in small quantities in order to affect the food’s keeping quality, texture, consistency, appearance, odor, taste, alkalinity or acidity, or to serve any other technological function in the manufacture, processing, preparation, treatment, packing, packaging transport, or storage of the food, and that results or may be reasonable expected to result directly or indirectly in the substance or any of its by‐products becoming a component of, or otherwise affecting the characteristics of, the food and includes any preservative, coloring substance, flavoring substance, flavor enhancer, antioxidant and food conditioner, but shall not include nutrient supplement, incidental constituent or salt.

4. Food Additives Functional Classes

As noted in the definition, food additives are divided into 7 functional classes in Malaysia, as follows:

1) Preservatives;
2) Antimicrobial agents;
3) Colouring substances;
4) Flavouring substances;
5) Flavour enhancers;
6) Antioxidants;
7) Food conditioners;
Definition and general application requirements of food additives above have been listed in the Part V of Food Regulations 1985.
Food conditioners are further divided into 11 subcategories, including:
1) Emulsifiers;
2) Antifoaming agents;
3) Stabilizers;
4) Thickeners;
5) Modified starches;
6) Gelling agents;
7) Acidity regulators;
8) Enzymes;
9) Solvents;
10) Glazing agents; and
11) Anticaking agents
Some of the substances listed within the functional class for food conditioner may also be used in certain instances as food processing aids.

5. Permitted Food Additives and Maximum Limits

Basically, only permitted food additive can be used in food processing within specified use limitations as required by regulation. Permitted food additives and maximum limits can be found in the schedules of the Food Regulations 1985. For some specified food for particular population such as children and infants, the regulation also listed the permitted food additives.

General permitted food additivePermitted food additive for infants and children food
  • Sixth Schedule (Regulation 20): Permitted Preservative;

  • Seventh Schedule (Regulation 21): Permitted Colouring Substance;

  • Eighth Schedule (Regulation 2):Permitted and Prohibited Flavoring Substance;

  • Ninth Schedule (Regulation 23): Permitted Flavour Enhancer; 

  • Tenth Schedule (Regulation 24): Permitted Antioxidant That May Be Added;

  • Eleventh Schedule (Regulation 25): Permitted Food Conditioner;

  • Twenty-First Schedule: Nutrient Levels & Permitted Food Additive in Infant Formula;

  • Twenty-Second Schedule: Nutrient Levels & Permitted Food Additive in Canned Food For Infant & Children;

  • Twenty-Third Schedule: Permitted Food Additive in Cereal-based Food for Infants and Children.

Particularly, for flavorings, permitted flavorings substances that can be used in food also include:
1) Those listed in one or more of the following publications:

a) GRAS (Generally Recognized As Safe (GRAS) flavouring substances published by the Flavor and Extract Manufacturers’ Association of the United States (FEMA) contained in the Food Technology, a publication of the Institute of Food Technologists);
b) Flavourings, List of Codex Specifications for Food Additives (CAC/MISC 6);
2) Natural flavouring substance either in its raw state or after processing by traditional preparation process including drying, roasting, and fermentation.
The regulation particularly listed prohibited food flavoring substance, however, there is no other negative list of prohibited food additives, since only permitted additives are allowed to be used in food. Limitations on the use of permitted food additives are that they must not be used to conceal any damage to or any inferiority in the quality of foods.

6. Specifications Standards for Food Additives

Specifications for food additives are introduced in standards of MS 1281 Part 1 to Part 8 for acidity regulators, preservatives, antioxidants, flavour enhancers, stabilizers, thickeners and gelling agents, solvents, anticaking agents and colouring substances. Those standards contains specifications of food additives, weights and measures, contaminants, methods of analysis and sampling, and food additive manufacturing standards.

7. Application for the Use of Food Additives

New food additives or extension of usage scope should be evaluated by the Expert Committee on Food Additives and Contaminants and approved by the FSQD. The assessment of applications to be made for existing permitted additives to be added into other standardized food items within the Food Regulations will mainly focus on evaluation of technological function and proposed minimum and maximum levels, and exposure assessment for additives which have an ADI. For new food additive application, applicant should also prove the risk control solutions during processing and conduct pharmacological and toxicological investigations. It is also worth noting that application for additive used in food packaging are also included in food additive application scope and the difference of assessing procedure is that food contact additive migration level from food packaging to food should be provided.

7.1 Required documents for application  

There are two main documents required:

  • During application for use of previously unapproved items both Parts A and B must be provided;

  • During application for the extension of the use of an approved items, only Part A is needed

7.1.1 PART A

1)   Administration information of applicant;

2)   Product information and intended using scope;

    (a) chemical and/or common name of proposed additive (N.B.- Trade Names are not acceptable);
    (b) specific type of food for which requested and classification of product under Food Regulations 1985 (State the proposed regulation number and reason);               
    (c ) proposed minimum and maximum levels of use in each item shown in (b).

3)  The processing function of additive in respect of intended food;

4)  Show evidence as to whether or not the same objectives can be obtained by good manufacturing practices or by additives currently approved in Malaysia;

5)  State the limits of the probable daily intake of the additive in the diet;

6)  Current approval or rejection status in other countries;

7)  Chemical and physical specifications;

8)  Recognized standard of purity for the additive, e.g. Joint FAO/WHO Expert Committee   on Food Additives (JECFA), Food Chemicals Code, British Standards Institute, etc.

9)  Stability and persistence of the additive in intended food;

10)  Advantages for consumer to use this additive;

11)  Maximum migration level of the additive if used in packaging materials;

12) Requests from food manufacturers for such food additive;

13)  Verification on the amount of additive in raw, processed and/or finished food and the determination method.

7.1.2 PART B

Information regarding Part B will be treated in confidence by the Technical Committee on the Drafting of the Food Regulations and no disclosure will be made.

1)  Manufacturing procedure;
2) Analytical control method used during the various stages of manufacturing, processing and packing;
3) Pharmacological and toxicological investigations carried out according to the general terms of reference given in World Health Organization Technical Report, Series 144, "Procedures for the testing of intentional food additives to establish their safety for use".       

8. Labeling Requirement 

There shall be written in the label on the package containing food additive imported, manufactured, advertised for sale or sold:

(a) the words “(state the chemical name of the food additive) as permitted (state the type of food additive)”; provided that in the case of coloring substance or flavoring substance it shall be sufficient to state the common name or the appropriate designation of that food additive in place of the chemical name;
(b) A statement giving direction for its use according to requirements provided by Food Regulations 1985.