Malaysia Proposes Major Amendments to Food Regulations, Introducing Lactose and Immunity Claims

"The Ministry of Health Malaysia, through its Public Consultation Document Bil 3/2025, has proposed comprehensive amendments to the Food Regulations 1985, focusing on nutrition and functional claims as well as the inclusion of advanced ingredients in infant and young child formulations. One of the key proposals is the introduction of specific criteria for lactose-related claims, allowing products to be labelled as “Low Lactose” when lactose levels do not exceed 2.0 g per 100 g or 100 ml, and “Lactose Free” when lactose is limited to a maximum of 0.5 g per 100 g or 100 ml. This move supports better consumer guidance, particularly for individuals with lactose intolerance. Additionally, the amendments include the authorization of a new nutrient function claim for Vitamin C, permitting manufacturers to state that “Vitamin C contributes to the normal function of the immune system,” provided the product contains at least 5 mg per 100 g (solid), 7.5 mg per 100 ml (liquid), or 5 mg per 100 kcal.

Another significant inclusion is the functional claim for probiotics, specifically Lactobacillus rhamnosus (LGG), acknowledging its role in supporting immune response. To make this claim, products must contain a minimum of 1 × 10⁹ CFU of live cells per serving, with no additional qualifying conditions. Furthermore, the proposal introduces human milk oligosaccharides (HMOs) such as 3’-Sialyllactose (3’-SL), 6’-Sialyllactose (6’-SL), Lacto-N-Tetraose (LNT), and combined 2’-Fucosyllactose (2’-FL) and DiFucosyllactose (DFL) into infant formula, follow-up formula, and young children’s milk. These ingredients are assigned strict maximum limits depending on the product type—for example, up to 20 mg of 3’-SL and 160 mg of 2’-FL/DFL per 100 ml in infant formula, while slightly lower limits apply in follow-up and young children formulas.

Manufacturers must ensure analytical capability for lactose and HMO measurement, adherence to approved claim wording, and validation of probiotic viability. These changes mark a progressive step toward modernizing nutritional regulations while enhancing consumer protection and transparency."