Malaysia has amended its food regulations to include new functional claims and nutrient limits for infant and child nutrition products, including L. casei Shirota, GOS, PHGG, and fucosyllactose variants, across multiple product categories.
Malaysia Expands Ingredients and Claims for Child Nutrition
New prebiotics, probiotics and labeling rules apply to infant and follow-up formulas.
What changed
L. casei Shirota recognized as a functional component with defined claims and minimum requirements.
GOS and PHGG permitted as additives with specific nutrient thresholds.
3’-FL and 3’-SL allowed as optional ingredients in infant formula and follow-up formulas.
New lactose content claims for ‘low’ and ‘free’ established in regulatory tables.
Who it affects
Infant formula manufacturers must comply with new maximum nutrient levels for prebiotics.
Importers of formulated milk powder must verify labels meet new function claim standards.
Compliance Answer: New Functional Claims and Nutrient Limits for Infant and Child Nutrition Products in Malaysia
Malaysia has introduced amendments to the Food Regulations 19851 to regulate functional claims, nutrient limits, and permitted ingredients for infant and child nutrition products, including Lactobacillus casei Shirota (L. casei Shirota), galactooligosaccharides (GOS), partially hydrolyzed guar gum (PHGG), and fucosyllactose variants (2′-FL, 3′-FL). These changes are governed by the Food Act 19831 and enforced by the Food Safety & Quality Programme, Ministry of Health Malaysia (MOH). Below is a structured breakdown of the key requirements.
1. Functional Claims and Nutrient Conditions
a) New Functional Claims (Fifth A Schedule, Table IV)
The amendments introduce specific conditions for functional claims in food products, including minimum amounts and permitted statements:
| Component | Function Claim | Minimum Amount Required | Conditions | Source |
|---|---|---|---|---|
| Galactooligosaccharide (GOS) | "Helps increase beneficial intestinal bacteria" | 1.5 g per 100 g or 100 ml of product | Must not be used in infant formula or follow-up formula2. | 2 |
| Lactobacillus casei Shirota | "Helps increase beneficial intestinal bacteria" | 1 × 10⁸ CFU per 100 g or 100 ml of product | Must be viable at the end of shelf life1. | 1 |
| Lactobacillus rhamnosus (LGG) | "Helps increase beneficial intestinal bacteria" | 1 × 10⁶ CFU per 100 g or 100 ml of product | Must be viable at the end of shelf life3. | 3 |
b) Nutrient Content Claims (Fifth A Schedule, Table I)
- Lactose Claims:
- Vitamin C Function Claim:
- New permitted claim: "Vitamin C contributes to the normal function of the immune system"3.
2. Permitted Added Nutrients and Optional Ingredients
a) Dietary Fibre (Twelfth Schedule, Table I)
- Partially Hydrolyzed Guar Gum (PHGG) is now permitted as a dietary fibre in food products2.
b) Formulated Milk Powder for Children (Sixteenth AA Schedule, Table II)
New optional ingredients with specified maximum nutrient levels:
| Ingredient | Maximum Level | Source |
|---|---|---|
| 3′-Fucosyllactose (3′-FL) | 1.2 g/L (reconstituted product) | 2 |
| 2′-Fucosyllactose (2′-FL) | 1.2 g/L (reconstituted product) | 1 |
| 3′-Sialyllactose (3′-SL) | 0.2 g/L (reconstituted product) | 3 |
| 6′-Sialyllactose (6′-SL) | 0.2 g/L (reconstituted product) | 3 |
| Lacto-N-tetraose (LNT) | 0.6 g/L (reconstituted product) | 3 |
| Mixture of 2′-FL and DiFucosyllactose (DFL) | 1.2 g/L (reconstituted product) | 3 |
c) Infant Formula and Follow-Up Formula (Twenty-First and Twenty-First A Schedules)
New optional ingredients with maximum nutrient levels for:
- Infant Formula (Table IA, Twenty-First Schedule):
- Follow-Up Formula (Table III, Twenty-First A Schedule):
3. Compliance Timeline and Stakeholder Actions
a) Adoption and Enforcement
- Proposed Date of Adoption: To be determined by MOH.
- Proposed Date of Entry into Force: 6 months after publication in the Federal Gazette1, 2, 3.
- Comment Period:
b) Key Obligations for Industry
- Labelling Requirements:
- Formulation Limits:
- Documentation:
- Manufacturers must retain evidence of compliance (e.g., viability of probiotics, nutrient analysis) for MOH inspections.
4. Regulatory Authority and Contact
- Enforcing Agency: Food Safety & Quality Programme, Ministry of Health Malaysia
- Address: Level 4, Menara Prisma, No. 26, Jalan Persiaran Perdana, Presint 3, 62675 Putrajaya, Malaysia.
- Tel: +603-88850797
- Email: sps.fsqd@moh.gov.my
- Website:1(https://hq.moh.gov.my/fsq)
Summary Answer
Malaysia’s Food Regulations 1985 have been amended to:
- Permit functional claims for GOS, L. casei Shirota, and LGG with minimum amounts (e.g., 1.5 g GOS/100 g2, 1 × 10⁸ CFU L. casei Shirota/100 g1) and conditions (e.g., viability requirements for probiotics).
- Set maximum nutrient levels for fucosyllactose variants (e.g., 1.2 g/L 2′-FL in infant formula1) and sialyllactose (e.g., 0.2 g/L 3′-SL3) in infant/child products.
- Introduce new dietary fibres (PHGG2) and lactose content claims (e.g., "lactose-free" ≤ 0.1 g/100 g3).
- Enforce compliance 6 months post-publication, with comment periods open until 24 April 2026 (G/TBT/N/MYS/133) and 7 August 2026 (G/TBT/N/MYS/135)1, 2.
All amendments are grounded in the Food Act 19831 and enforced by the Ministry of Health Malaysia. Manufacturers must align formulations, labelling, and documentation with these requirements to avoid penalties under the Act. For further details, contact the Food Safety & Quality Programme1, 2, 3.
Sources
- ↩ G/TBT/N/MYS/135 https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/TBTN26/MYS135.docx
- ↩ G/TBT/N/MYS/133 https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/TBTN26/MYS133.docx
- ↩ G/TBT/N/MYS/129 https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/TBTN25/MYS129.DOCX