Regulation of Probiotics in Malaysia

What You Need To Know

It is important to ensure that there are food laws in the country to regulate the sale of foods and beverages containing probiotics, so as to safeguard the interest of consumers.

To protect consumers from fraudulent practices, the Food Safety & Quality Division of the Ministry of Health (MOH) enacted a regulation on probiotic cultures in April 2018. Regulation 26A provides a definition for probiotics regulates its addition to foods. The labelling requirements for foods with added probiotics are clearly spelt out.

The main aspects of Regulation 26A* are as follows :

  1. Probiotic culture means live microorganisms which when administered in adequate numbers confer health benefits to the human body; the key words to take note here are “live microorganisms” and “in adequate numbers”;
  2. Only specific bacterial strains have been recognised by MOH as probiotic cultures and are listed in the regulation. This list currently contains 13 Bifidobacterium strains and 19 Lactobacillus bacterial strains.
  3. This regulation stipulates that only these bacterial strains in the approved list may be added to foods and beverages.
  4. This law requires that the probiotic cultures added must remain viable (live) and the viable count shall not be lessthan 106 cfu/ml or cfu/g of food during the shelf life of the food or beverage; see item 1 above.
  5. Examples of foods and beverages that may contain added probiotic cultures are cultured milk, cultured milk drink, fermented milk, yoghurt, cultured cream or sour cream,
  6. To assist consumers in identifying foods that contain probiotic cultures, this law has spelt out clearly the labeling requirements. The following must be clearly written on the label of such foods:
    • the words “CONTAINS (xxx number) of PROBIOTIC CULTURES”;
    • the genus, species and strain of the probiotic cultures added;
    • the direction for storage before and after package is opened.
  7. In addition, where the media used for propagation and maintenance of the probiotic cultures are derived from animal, the common name of such animal shall be stated on the label of that food.
  8. The regulation permits a general health claim to be made for foods with added probiotic cultures. The following words may be used :
    • "Probiotic cultures help in improving intestinal/or gut function"
    • in any other words of similar meaning
* To retrieve the entire regulation on probiotics, including the list of probiotics strains that are permitted to be added to foods, kindly refer to the Food Regulations 1985 at Food Safety and Quality Division (FSQD) website HERE