Food Compliance
Intelligence & Solutions

Malaysia Special Purpose Food Regulation

Lennie Tao Last updated on: Sep 18, 2024

1. Definition and Classification

According to the Food Regulations 1985, "special purpose food" refers to food that is specifically suitable for individuals with special nutritional needs, including those prescribed in the regulations below. [Notes: "Infant" below refers to any person up to 12 months of age, and "children" refers to persons aged over 12 months up to 3 years.]

Regulation No.

Product category

Explanation

Regulation 389 (of the Food Regulations 1985)

 

Infant formula

  • Food described or sold as an alternative for human milk for the feeding of infants

  • Prepared from milk of cow or other animal or other edible constituent of animal or both, including fish, or from plant suitable for infant feeding

Regulation 389A

Follow-up formula

  • Food intended for use as a liquid part of the weaning diet for an infant from the sixth months on and for children

  • Prepared from the milk of cows or other animals or other constituents of animal or plant origin, which have been proved to be suitable for infants from the sixth months on and for children

Regulation 390

Canned food for infants and children (excl. products specified in Regulation 391)

  • Any wholesome food or mixtures of wholesome food that is sold as suitable for feeding to infants or specifically suitable for feeding to children

  • Homogenous or comminuted in the following forms: (i) strained food of a fairly uniform, small particle size which does not require chewing before being swallowed; or (ii) non - strained food that ordinarily contain particles of a size to encourage chewing by infants and children …

Regulation 391

Processed cereal-based foods for infants and young children

  • Foods prepared primarily from one or more milled cereals, such as wheat, rice, barley, oats, rye, maize, millet, sorghum and buckwheat which shall constitute at least twenty-five per cent (25%) of the final mixture on a dry weight basis

  • Intended for feeding infants as a complementary food generally from the age of six months onwards, taking into account infants’ individual nutritional requirements, and for feeding young children as part of a progressively diversified diet

Regulation 392

Low energy food

Special purpose food that is particularly suitable for persons adopting a restricted energy diet

Regulation 393

Formula dietary food

Formula dietary food shall be food that is described in the label on a package containing that food as being suitable as a complete diet when consumed in accordance with the directions contained in the label.

Regulation 393A

Special dietary foods with low sodium content including salt substitute

Foods with special dietary value as the result from the reduction, restriction or removal of sodium and include salt substitutes with low sodium content

2. Competent Authority and Responsibilities

Competent authority

Responsibility

Ministry of Health (MOH), especially the Food Safety and Quality Program

  • The leader of the country’s food safety and quality control

  • Food safety and quality policies and legislation

  • Monitoring and enforcement activities on imported / domestic foods

Ministry of Domestic Trade and Cost of Living (KPDN)

Formulation of policies and strategies pertaining to the development of the domestic trade, including distributive trade and consumerism sectors

Others

3. Regulatory Framework

The Food Act 1983 and its subsidiary legislation, the Food Regulations 1985, are the fundamental law and regulation for food safety and quality. In addition to these regulations, enterprises may also need to comply with other regulations issued by other departments:

4. Market Access Approval

4.1 Overall import procedure

Before exporting products to Malaysia, overseas enterprises must ensure that the food products comply with the provisions specified in the Food Act 1983 and Food Regulations 1985. Part of the product compliance requirements is detailed in “4.2 Product Compliance.” Please note that, as per the Food Regulation 1985, no person shall import, manufacture or advertise for sale or sell, any food other than those prescribed in regulations 389 to 393, as special purpose food without the prior written approval of the Director.

Moreover, before the exportation, importing and shipping agents (customs brokers) of overseas enterprises are required to register with the Malaysian Food Safety Information System (FoSIM). The system is linked to the Royal Malaysian Customs Department's system known as the Customs Information System (CIS), allowing importers, shipping agents, and Authorized Officers to manage food importation activities electronically using a risk-based approach.

The overall importation procedure is summarized below.

4.2  Product compliance

The compliance requirements for different products are outlined in the Food Act 1983 and the Food Regulations 1985. For example, regulations regarding incidental constituents, like mycological contaminants, can be found in Part VII of the Food Regulations 1985.                  

Part of the compliance requirements for special purpose foods are summarized as below. 

Regulation No.

Product category

Product compliance

Regulation 389

Infant formula

Please refer to the Food-pedia: Malaysia Baby Formula Regulation.

Regulation 389A

Follow-up formula

Regulation 390

Canned food for infants and children (excl. products specified in Regulation 391)

  • Shall contain the nutrient and corresponding amount in Table I to the Twenty-second Schedule

  • May use the food additives following Table II to the Twenty-second Schedule

  • The food or the ingredients used in making the product shall not have been treated by ionizing radiation.

  • The addition of salt to fruit product and dessert product based on fruit shall be prohibited.

Regulation 391

Processed cereal-based foods for infants and young children

  • May use the food additives as specified in Twenty-third Schedule

  • Food conditioner listed in the Table I to the Eleventh Schedule may be present in the product as a result of carry-over from a raw material

  • Products or ingredients used in making the product shall not contain partially hydrogenated oils and fats, and shall not have been treated by ionizing radiation.

  • Only L (+) lactic acid producing culture may be used.

Regulation 392

Low energy food

  • Where any specified food is prepared in the form of low energy food, the low energy food so prepared shall comply with the standard for that specified food as prescribed in these Regulations, except that such low energy food shall not have a total energy value exceeding those prescribed in the Twenty - Fourth Schedule and may contain permitted non - nutritive sweetening substance, aspartame and erythritol.

  • The low energy food of the type specified in column (1) of the Twenty - fourth Schedule shall not have a total energy value exceeding those specified in relation thereto in column (2) of the said Schedule.

Regulation 393

Formula dietary food

  • Shall contain, in the quantity stated on the label as the quantity to be consumed in one day, not more than the amount of nutrient supplements specified in Table III of the Twelfth Schedule

  • May contain permitted nutrient supplement and permitted food conditioner

Regulation 393A

Special dietary foods with low sodium content including salt substitute

For low sodium food:

Processed without the addition of sodium salts, and the sodium content of which shall be— (a) not more than half of that of the normal product consumed; and (b) not more than 120mg/100g of the final product as normally consumed

 

For very low sodium food:

Processed without the addition of sodium salts, and the sodium content of which shall be— (a) not more than half of that of the comparable normal product as consumed; and (b) not more than 40mg/100g of the final product as normally consumed

 

Salt substitutes shall contain the ingredients specified in column (1) of the Twenty-fourth A Schedule in accordance with the requirements specified in column (2)

Food additive usage compliance in Malaysia can be found in ChemLinked's FoodCheck tool.

5. Label

Special purpose foods must adhere to the following mandatory labeling items for general food:

  1. Appropriate designation /description of the food product /name

  2. List of ingredients

  3. Statement on ingredient /additives

  4. Quantity information (Minimum net weight /volume /number of package content)

  5. Nutrition label

  6. Manufacturer information

  7. Importer information

  8. Country of origin

  9. Date marking

In addition, different product categories shall meet the special labeling requirements set in corresponding product regulations.

Category

Special labeling requirements for different products

Infant formula

Please refer to the Food-pedia: Malaysia Baby Formula Regulation.

Follow-up formula

Canned food for infants and children (excl. products specified in Regulation 391)

  • Label the words “STRAINED” or “NON-STRAINED”, followed by the product name

  • Label the words "NOT TO BE GIVEN TO INFANTS UNDER SIX (6) MONTHS OF AGE UNLESS ADVISED BY A HEALTH PROFESSIONAL"

  • Nutrition information of energy, protein, carbohydrate, fat, vitamin and mineral

  • The direction for the preparation and use of the food and instruction on its storage before and after the package has been opened

  • A statement that canned food for infants and children shall not be fed through bottle or any other word of similar meaning

Processed cereal-based foods for infants and young children

  • The words “NOT TO BE GIVEN TO INFANTS BELOW SIX (6) MONTHS OF AGE UNLESS ADVISED BY HEALTH PROFESSIONAL”

  • The words “FOR OPTIMAL INFANT HEALTH, BREASTFEEDING SHOULD CONTINUE UP TO TWO (2) YEARS OF AGE ALONG WITH COMPLEMENTARY FEEDING”

  • Nutrition information of energy, protein, carbohydrate, fat, vitamin and mineral

  • Direction on the method of preparing the food and its storage before and after the package has been opened

  • A statement that processed cereal-based foods for infants and young children shall not be fed through bottle or any other words of similar meaning

  • Products consisting of cereals which are or have to be prepared for consumption with milk or other suitable nutritious liquids shall state “Only milk shall be used for dilution or mixing” or an equivalent statement

Low energy food

  • The words "low energy food"

  • The total weights and the separate percentages of carbohydrate, protein and fat in the package

  • The total energy value in the package or the total energy in each 100 ml or 100 gram, as the case may be

  • An indication that a diet of low energy food requires the supervision of a physician

Formula dietary food

  • The words “formula dietary food”

  • A statement of the quantity of the food to be consumed in one day

  • A statement of the energy yield, expressed in kilocalorie(kcal) or kilojoule (kj) or both, of that quantity of the food

  • The proportion of protein, fat and carbohydrate in the food

Special dietary foods with low sodium content including salt substitute

For low sodium food or very low sodium food:

  • The words "low sodium" or "very low sodium"

  • The sodium content to the nearest multiple of 5mg/100g and, in addition, per as specified serving of the food as normally consumed

  • The average carbohydrate, protein and fat content in 100g of the product as normally consumed, as well as the kilocalorie or kilojoule value

  • A statement on the addition of the salt substitutes

  • When a salt substitute, composed entirely or partially of a potassium salt, has been added, the total amount of potassium salt expressed as mg cation/100g of the food as normally consumed

  • Direction for storage and information regarding its keeping before and after the package has been opened

 

For salt substitutes:

  • The words "low sodium salt substitute" or "low sodium dietetic salt"

  • The amount of the cations sodium, potassium, calcium, magnesium, ammonium, choline per 100g w/w contained therein

  • The words "take only on medical advice" on the principal display panel

Details regarding labeling requirements can be found at ChemLinked's FoodCheck tool. For allergen labeling, please read ChemLinked article "How to Label Food Allergen Information for the Malaysian Market".

Recommended materials:

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