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Malaysia Infant and Young Child Food Labelling Rules
In Malaysia, infant formula, follow-up formula, canned food for infants and children, and cereal-based food for infants and children are all classed as Special Purpose Food, regulated under Part VIII of the Food Regulations 1985 (made under the Food Act 1983), with the Food Safety and Quality Division (FSQD / BKKM) of the Ministry of Health as the competent authority. The labelling core for this class is not only ingredients and nutrition but a strict set of public-health rules: the breast-milk-first warning must be printed, implying the product is superior to breast milk is prohibited, images of infants and feeding bottles are prohibited, and a statutory age warning must be shown according to the product class. A design error means not only rejection but potentially penalties under the Food Act.
Who regulates it, and which products it covers
Under Regulation 388, "special purpose food" means food labelled or described as specially suitable for people with special nutritional needs. The age definitions for infant and young child food are clear: "infant" means under 12 months and "children" means over 12 months up to 3 years. This chapter covers four classes, each with its own standard:
- Infant formula (Regulation 389)
- Follow-up formula (Regulation 389A)
- Canned food for infants and children (Regulation 390)
- Cereal-based food (Regulation 391)
Any product that is not one of the above four but is to be sold as "special purpose food" requires prior written approval from the Director of the Food Safety and Quality Division (Regulation 388(3)).
Statutory warnings for the four classes
The mandatory warning and type size differ for each class; the following is the wording prescribed by the Regulations (the label must present the English original text):
| Class | Statutory warning on the principal display panel | Other mandatory warnings |
|---|---|---|
| Infant formula 389 | "BREAST MILK IS THE BEST FOOD FOR INFANTS" (≥10 point on a 500 g can, scaled up proportionally with can size) | "INFANT FORMULA" at a height ≥ half the brand name; "INFANT FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER 6 MONTHS OF AGE" ≥4 point bold |
| Follow-up formula 389A | "BREAST MILK IS THE BEST FOOD FOR INFANT" (≥10 point, scaled up proportionally as above) | "NOT TO BE GIVEN TO INFANTS BELOW 6 MONTHS OF AGE" ≥4 point; "FOLLOW-UP FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER SIX MONTHS OF AGE" ≥4 point bold; plus "Before deciding to use this product seek the advice of a health professional." |
| Canned food for infants and children 390 | "NOT TO BE GIVEN TO INFANTS UNDER SIX (6) MONTHS OF AGE UNLESS ADVISED BY A HEALTH PROFESSIONAL" ≥10 point | Label "STRAINED" or "NON-STRAINED" by texture ≥10 point; must state not to be fed by feeding bottle; sodium content ≤1 g/kg (ready-to-eat basis) |
| Cereal-based food for infants and children 391 | "NOT TO BE GIVEN TO INFANTS BELOW SIX (6) MONTHS OF AGE UNLESS ADVISED BY HEALTH PROFESSIONAL" ≥10 point | State the product form (e.g. Dry Cereal for Infants); "FOR OPTIMAL INFANT HEALTH, BREASTFEEDING SHOULD CONTINUE UP TO TWO (2) YEARS OF AGE ALONG WITH COMPLEMENTARY FEEDING" ≥10 point; must state not to be fed by feeding bottle |
In addition, each class must state the content of energy (kcal/kJ), protein, carbohydrate, fat, vitamins and minerals (per 100 g and per recommended serving), together with the method of preparation, feeding-amount advice and storage before and after opening.
Common red lines: things you absolutely must not do
Whatever the class, the following are prohibitions expressly set out in the Regulations:
- Prohibited imagery: the label must not show pictures or graphics of infants, mothers, feeding bottles or teats; a schematic illustration may be used only to explain the method of preparation.
- Prohibited superiority claims: it must not claim the product is superior to breast milk.
- Prohibited terms: formula may not use "humanised" or "maternalised"; it must not claim "enriched" or "vitaminised". "Infant formula with iron" may be labelled only if it contains ≥1 mg of iron per 100 available kcal.
- No bundled promotion: accompanying literature must not contain promotional or advertising information for other products.
These rules echo the spirit of the WHO International Code of Marketing of Breast-milk Substitutes and are the areas most closely scrutinised at audit.
Language and type size
Under Regulation 388(6), all statutory particulars on a special purpose food label must be in Bahasa Malaysia, with a translation in any other language optionally added — this is stricter than general food (where imports may use Malay or English). Type size follows Regulation 12: general statutory particulars ≥10 point, while the ingredient list and manufacturer / importer details may be ≥4 point, in a colour in strong contrast with the background. See Label type size and legibility rules.
Common mistakes
- Putting the original foreign label straight on the market, missing the Malay breast-milk warning and age warning.
- Reusing a cute baby illustration from foreign packaging, crossing the prohibited-imagery red line.
- Forgetting to add "seek the advice of a health professional" on follow-up formula.
- Using marketing language implying superiority such as "close to breast milk" or "most complete nutrition".
Frequently asked questions (FAQ)
Q: What is the difference between infant formula and follow-up formula? Infant formula (389) is a substitute for breast milk, suitable for infants from birth; follow-up formula (389A) is the liquid part of a weaning diet, not to be given to infants under 6 months. The two have different statutory warnings and applicable ages.
Q: Must the label be in Malay? Can it be English only? No. Regulation 388(6) requires all statutory particulars of special purpose food to be in Malay; a translation into English or Chinese may be added, but it cannot be English only.
Q: Can a cute baby photo be placed on a formula can? No. The Regulations expressly prohibit pictures of infants, mothers, feeding bottles or teats; only a schematic illustration demonstrating the method of preparation is an exception.
Q: Is there an upper limit on the sodium content of canned food for infants and children? Yes. On a ready-to-eat basis the total sodium content must not exceed 1 g/kg, and fruit-based desserts may not have salt added.
Q: Does imported infant and young child food need separate approval? If it falls within the four classes already standardised by Regulations 389–393, complying with the standard is sufficient; if it is to be sold as another form of "special purpose food", prior written approval from the FSQD Director is required.
Pre-market self-check
- [ ] Confirmed which class the product belongs to (389 / 389A / 390 / 391)
- [ ] The breast-milk-first warning wording and type size on the principal display panel are correct
- [ ] The applicable-age warning and "not the only food" warning are present
- [ ] No imagery of infants / mothers / feeding bottles / teats
- [ ] No prohibited claims such as superiority, humanised, enriched
- [ ] All statutory particulars are in Malay, type size ≥10 point
- [ ] Nutrition labelling, method of preparation, feeding amount and storage are complete
Summary: The key to infant and young child food labelling is not aesthetics but placing the breast-milk-first and age warnings word for word, removing every element that implies superiority or is imagery-based, and using Malay throughout. Get the classification and warnings right and the label is more than half done. Related further reading: Food for Special Dietary Uses (FSDU), Food names and prescribed standards and the pillar Malaysia food labelling guide.
This article is compiled from official sources for reference only; actual compliance is subject to the latest text and review by the competent authority.
📚 Sources / official references
This article is compiled from the official sources above for reference only; actual compliance is subject to the authorities' latest regulations and review.
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