Malaysian Infant Formula Regulation

1. Definition and Classification

Baby formula is subject to the supervision of special purpose food in Malaysia, which includes infant formula, follow-up formula and special formula.

Infant formula (for infants 0-12 months) is the food described or sold as an alternative for human milk for the feeding of infants. It is a product prepared from milk of cow or other animal, or other edible constituent of animal (including fish) or both, or from plant suitable for infant feeding.

Follow-up formula (for infants 6 months to 3 years) shall be food intended for use as a liquid part of the weaning diet for an infant from the sixth months on and for children (hereinafter refers to person from the age of over 12 months up to the age of 3 years). It is a product prepared from the milk of cows or other animals, other constituents of animal or plant origin. All these raw materials have been proved to be suitable for infants from the sixth months on and for children.

Special formula (infant or follow-up formula for special dietary or medical purposes) means a formula which is specially processed or formulated to satisfy well-recognised and particular dietary requirements known to exist as a result of a physical or physiological condition, a specific disorder or both. Examples include but are not limited to formulas for pre-term or low birth-weight infants, cow’s milk hypersensitivity, carbohydrate intolerance and other metabolic disorders.

All of the categories above include ready-to-feed formula, which is prepared in liquid form in disposable bottle, tetra-pack, etc.

2. Competent Authority and Responsibilities

Food Safety and Quality Division¹ (FSQD), as the competent authority for food safety in Malaysia, is responsible for ensuring food safety along the food supply chain in order to protect the public against health hazards and fraud in purchasing and using food, etc.

3. Regulatory Framework

Food Act 1983² and its subsidiary legislation, Food Regulations 1985³, are the most fundamental law and regulation for food safety and quality.

4. Product Compliance

4.1 Ingredient requirements

	Infant formula	Follow-up formula
Nutrient level	Table 1 of the Twenty-First Schedule of Food Act 1983	Table 1 of the Twenty-First A Schedule of Food Act 1983
Optional ingredients and use limits	Table 1A of the Twenty-First Schedule; Optional ingredients include cytidine 5’-Monophosphate, etc.	Table 3 of the Twenty-First A Schedule; Optional ingredients include galacto-oligosaccharide, lutein, etc.
Food additives	Table 2 of the Twenty-First Schedule	Table 2 of the Twenty-First A Schedule
Food additives	No other food additives shall be used in infant formula as a result of carry over from raw material or other ingredients.
Others	Ingredients shall not have been treated by ionizing radiation.

4.2 Labeling requirements

	Infant formula	Follow-up formula
Mandatory labeling statements	“BREAST MILK IS THE BEST FOOD FOR INFANTS”; "INFANT FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER 6 MONTHS OF AGE"	“BREAST MILK IS THE BEST FOOD FOR INFANT”; “FOLLOW-UP FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER SIX MONTHS OF AGE”; “NOT TO BE GIVEN TO INFANTS BELOW 6 MONTHS OF AGE”; “BEFORE DECIDING TO USE THIS PRODUCT, SEEK THE ADVICE OF A HEALTH PROFESSIONAL”.
Other mandatory items	The specific types of carbohydrate present; The words "infant formula with iron" shall not appear in the label of any infant formula unless the product contains not less than 1 mg iron (Fe) per 100 available calories.	The instructions for correct preparation and a warning against the health hazards of incorrect preparation;
Other mandatory items	The words “INFANT FORMULA”/“FOLLOW-UP FORMULA”; The name of the animal or plant from which the ingredients are derived; The amount of energy, protein, carbohydrate, fat, vitamin and mineral; A statement suggesting the amount of the prepared food to be given at one time, and the number of times such amount is to be given per day; l Direction for storage and information regarding its preservation before and after the package has been opened.
Forbidden labeling items	Words like “humanised” or “maternalised” are forbidden to be indicated; No label of a formula shall claim that such formula is enriched or vitaminised; No label of an infant formula shall display any claim of superiority of the product to breast milk; No label of a formula shall display any picture or graphics of infants or babies or parts of infants or babies, mothers, feeding bottles or teats. (For the purposes of illustrating the preparation methods of the follow-up formula, graphics may be used.)

4.3 Marketing requirements

To uphold the supremacy of breast milk and support breastfeeding, a code called Code of Ethics for the Marketing of Infant Foods and Related Products⁴ was formulated to protect, support and promote breastfeeding practices through strict control of the marketing of baby food products and breastfeeding equipment for mothers.

Based on the Code, manufacturers and distributors of infant/follow-up formula shall

not market, promote, or advertise any designated products in such a way as to a) challenge or undermine the supremacy of breast milk; or b) compete in any way with breast milk;
not provide samples of infant/follow-up formula, etc.
not advertise or promote infant/follow-up formula in the health care system, child care centres, retail outlets or on the mass media;
not conduct any activity that involves infants, young children, pregnant women and mothers of infants and young children for the purpose of promoting products;
not permit company personnel to have direct or indirect contact with pregnant women, parents of infants, members of their families and child-care providers for the purpose of promoting designated products;
...

Check Food Act 1983, Food Regulations 1985 and the Code of Ethics for more details, or contact ChemLinked for more regulatory consultation service.

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China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

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