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 |
|
Regulation 389A | Follow-up formula |
|
Regulation 390 | Canned food for infants and children (excl. products specified in Regulation 391) |
|
Regulation 391 | Processed cereal-based foods for infants and young children |
|
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 |
|
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:
P.U. (A) 296 - Trade Descriptions (Marking of Quantity for Pre-packaged Goods) Order 2023
P.U. (A) 431 - Trade Description Order (Certification & Marking of Halal) 2011
General Procedure Import Meat, Poultry, Milk and Egg Products to Malaysia
Regulations for the Importation of Milk Products into Malaysia (FMD free countries or zones)
Regulations for the Importation of Milk Products into Malaysia (FMD infected countries or zones)
…
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) |
|
Regulation 391 | Processed cereal-based foods for infants and young children |
|
Regulation 392 | Low energy food |
|
Regulation 393 | Formula dietary food |
|
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:
Appropriate designation /description of the food product /name
List of ingredients
Statement on ingredient /additives
Quantity information (Minimum net weight /volume /number of package content)
Nutrition label
Manufacturer information
Importer information
Country of origin
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) |
|
Processed cereal-based foods for infants and young children |
|
Low energy food |
|
Formula dietary food |
|
Special dietary foods with low sodium content including salt substitute | For low sodium food or very low sodium food:
For salt substitutes:
|
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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