3.0 Compositional Aspects

Infant, Follow-up, Young Child Formula
Malaysia

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

	Composition Requirements
Infant Formula [1]	Nutrient Level (per 100 kcal) • Protein*: Minimum amount 1.8 g. Maximum amount 4.5 g  • Fat: Minimum amount 3.3 g (or 30% cal). Maximum amount 6 g (or 54% cal)  • Essential fatty acids (linoleate): Minimum amount 3% cal or 300 mg. Maximum amount is not prescribed  • Vitamin A (expressed as retinol). Minimum amount 250 IU. Maximum amount 500 IU • Vitamin D: Minimum amount 40 IU. Maximum amount 80  IU • Ascorbic acid (Vit. C): Minimum amount 8 mg. Maximum amount is not prescribed  • Thiamine (Vit. B1): Minimum amount 40 µg. Maximum amount is not prescribed  • Riboflavin (Vit. B2): Minimum amount 60 µg. Maximum amount is not prescribed  • Nicotinamide: Minimum amount 250 µg. Maximum amount is not prescribed  • Vitamin B6: Minimum amount 35 µg. Maximum amount is not prescribed  • Folic Acid: Minimum amount 4 µg. Maximum amount is not prescribed  • Pantothenic Acid: Minimum amount 300 µg. Maximum amount is not prescribed  • Vitamin B12: Minimum amount 0.15 µg. Maximum amount is not prescribed  • Vitamin K: Minimum amount 4 µg. Maximum amount is not prescribed  • Biotin: Minimum amount 1.5 µg. Maximum amount is not prescribed   • Vitamin E: Minimum amount 0.7 I.U./g linoleic acid in no case less than 0.7 I.U./100 kcal. Maximum amount is not prescribed   • Sodium (Na): Minimum amount 20 mg. Maximum amount 60 mg  • Potassium (K): Minimum amount 80 mg. Maximum amount 200 mg  • Calcium (Ca): Minimum amount 50 mg. Maximum amount is not prescribed (The Ca: P ratio shall not be less than 1.2 and not more than 2.0.)  • Phosphorus (P): Minimum amount 25 mg. The maximum amount is not prescribed  • Choline: Minimum amount 7 mg. The maximum amount is not prescribed  • Iron (Fe): Minimum amount 0.15 mg. The maximum amount is not prescribed  • Zinc (Zn): Minimum amount 0.5 mg. Maximum amount 1.5 mg   Notes: *The amounts are for protein of nutritional quality equivalent to that of casein. A greater quantity of other protein is permitted so long as it is in proportion to the biological value of the aforesaid amount. The quantity of the other protein shall not be less than 85% of that of casein.  - Where the maximum amount of the nutrient is not prescribed, the total daily intake of that nutrient arising from its uses in accordance with good manufacturing practice, does not present a hazard to health.
Follow-up Formula [2]	When prepared in accordance with the instructions for use, 100 ml of the ready-for-consumption product shall provide not less than 60 kcal and not more than 85 kcal of energy.  It shall contain nutritionally available carbohydrates suitable for the feeding of infants of six months and children in such quantities as to adjust the product to the energy density in accordance with the requirements set out below:  Nutrient Level (per 100 kcal) • Protein*: Minimum amount 3 g. Maximum amount 5.5 g  • Fat: Minimum amount 3 g. Maximum amount 6 g • Essential fatty acids (linoleate): Minimum amount 300 mg. Maximum amount is not prescribed  • Vitamin A (expressed as retinol): Minimum amount 250 IU (75 µg). Maximum amount 750 IU (225 µg)  • Vitamin D:  Minimum amount 40 IU (1 µg). Maximum amount 120 IU (3 µg) • Ascorbic acid (Vit. C): Minimum amount 8 mg. Maximum amount is not prescribed.   • Thiamine (Vit. B1): Minimum amount 40 µg. Maximum amount is not prescribed.   • Riboflavin (Vit. B2): Minimum amount 60 µg. Maximum amount is not prescribed.   • Nicotinamide: Minimum amount 250 µg. Maximum amount is not prescribed.   • Vitamin B6: Minimum amount 45 µg. Maximum amount is not prescribed. (Formulas shall contain a minimum of 15 µg of Vitamin B6 per gram of protein)  • Folic Acid: Minimum amount 4 µg. Maximum amount is not prescribed.  • Pantothenic Acid: Minimum amount 300 µg. Maximum amount is not prescribed.   • Vitamin B12: Minimum amount 0.15 µg. Maximum amount is not prescribed.   • Vitamin K1: Minimum amount 4 µg. Maximum amount is not prescribed.   • Biotin: Minimum amount 1.5 µg. Maximum amount is not prescribed.   • Vitamin E (% tocopherol compounds): Min 0.7 IU/g linoleic acid but in no case less than 0.7 IU/100 available kilocalories.  • Sodium (Na): Minimum amount 20 mg. Maximum amount 85 mg  • Potassium (K): Minimum amount 80 mg. Maximum amount is not prescribed.   • Chloride (Cl): Minimum amount 55 mg. Maximum amount is not prescribed.   • Calcium (Ca): Minimum amount 90 mg. Maximum amount is not prescribed. (The Ca: P ratio shall not be less than 1.2 and not more than 2.0)  • Phosphorus (P): Minimum amount 60 mg. Maximum amount is not prescribed.   • Magnesium (Mg): Minimum amount 6 mg. Maximum amount is not prescribed.    • Iron (Fe): Minimum amount 1 mg. Maximum amount 2 mg.  • Iodine (I): Minimum amount 5 µg. Maximum amount is not prescribed.   • Zinc (Zn): Minimum amount 0.5 mg. Maximum amount is not prescribed.   Notes: * Not less than 3.0 g per 100 available calories or 7.0 g per 100 available kilojoules of protein of nutritional quality equivalent to that of casein in or a greater quantity of other protein in inverse proportion to its nutritional quality. The quantity of the other protein shall not be less than 85% of that casein. The total quantity of protein shall not be more than 5.5 g per 100 available calories (or 1.3 g per 100 available kilojoules). - Where the maximum amount of the nutrient is not prescribed, the total daily intake of that nutrient arising from its use in accordance with good manufacturing practice does not present a hazard to health.
Young Child Formula [3]	Nutrient level (per 100g): • Biotin: Minimum amount 3.8 μg. Maximum amount is not prescribed • Calcium: Minimum amount of 175 mg. Maximum amount is not prescribed • Energy: Minimum amount 384 kcal. Maximum amount is not prescribed • Folic acid: Minimum amount 64 μg. Maximum amount is not prescribed • Iodine: Minimum amount 28 μg. Maximum amount is not prescribed • Iron: Minimum amount of 1.4 mg. Maximum amount is not prescribed • Magnesium: Minimum amount 22.8 mg. Maximum amount is not prescribed • Nicotinamide: Minimum amount 2.5 mg. Maximum amount is not prescribed • Pantothenic acid: Minimum amount 0.9 mg. Maximum amount is not prescribed • Riboflavin (vitamin B2): Minimum amount 0.2 mg. Maximum amount is not prescribed • Selenium: Minimum amount 5.9 μg. Maximum amount is not prescribed • Thiamine (vitamin B1): Minimum amount 0.2 mg. Maximum amount is not prescribed • Vitamin A: Minimum amount 132 μg. Maximum amount is not prescribed • Vitamin B6: Minimum amount 0.2 mg. Maximum amount is not prescribed • Vitamin B12: Minimumamount 0.4 μg. Maximum amount is not prescribed • Vitamin C: Minimum amount 9.4 mg. Maximum amount is not prescribed • Vitamin D: Minimum amount 1.5 μg. Maximum amount is not prescribed • Vitamin E: Minimum amount 1.7 mg. Maximum amount is not prescribed • Vitamin K1: Minimum amount 5.9 μg. Maximum amount is not prescribed • Zinc: Minimum amount of 1.5 mg. Maximum amount is not prescribed • Fat: Not less than 11.2 g per 100 g of fat and not more than 25 g per 100 g of fat  • Protein: Not less than 7g per 100 g of protein from milk

3.2 Raw Material Requirements

Infant Formula [1]

Infant formula or the ingredients used in the manufacturing of infant formula shall not have been treated by ionizing radiation.

Follow-up Formula [2] 

Follow-up formula or the ingredients used in the manufacturing of the follow-up formula shall not have been treated by ionizing radiation.

Young Child Formula [3]

Formulated milk powder for children or ingredients used in making the product shall not contain partially hydrogenated oils and fats and shall not have been treated by ionizing radiation.

3.3 Fortification

Refer to Section 3.4 below.

3.4 Other Permitted Ingredients

Infant Formula [4]

Infant formula may contain optional ingredients as specified in Table 1A of the Twenty-First Schedule listed below: 

Nucleotides: 

• Cytidine 5’-Monophosphate: maximum Level 2.50 mg/100 kcal 
• Uridine 5’-Monophosphate: maximum Level 1.75 mg/100 kcal 
• Adenosine 5’-Monophosphate: maximum Level 1.50 mg/100 kcal 
• Guanosine 5’-Monophosphate: maximum Level 0.50 mg/100 kcal 
• Inosine 5’-Monophosphate: maximum Level 1.00 mg/100 kcal 
• The total concentration of nucleotides in any infant formula shall not exceed 5mg per 100 kcal.
• Infant formula may contain: 
• Trans fatty acid not exceeding 1% of the total fat content; 
• Erucic acid not exceeding 1% of the total fat content; and 
• Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LC-PUFA) not exceeding 1% of the total fat content for n-3 LC-PUFA; and 2% of the total fat content for n-6 LC-PUFA (1% of the total fat content for arachidonic acid).
• The eicosapentaenoic acid (EPA) (20:5 n-3) shall not exceed that of docosahexaenoic acid (DHA) (22:6 n-3) content.

Probiotic cultures specified in Twelfth A Schedule Malaysia Food Regulations are permitted. The probiotic cultures added shall remain viable and the viable probiotic count shall not be less than 10^6 cfu/ml or cfu/g during the shelf life of such food. The probiotic cultures shall not contain transmissible antibiotic-resistant genes.

Follow-up Formula [5]

Follow-up formula may contain optional ingredients as specified in Table III to the Twenty-First A Schedule listed below:  

• Nucleotides*: Max level 16 mg per 100 kcal**
• Galactooligosaccharides (GOS): max level 0.72 g per 100 ml
• Oligosaccharide mixture containing 90% (weight per weight) galactooligosaccharides (GOS) and 10% (weight per weight) long-chain fructooligosaccharides (1cFOS): max level 0.8 g per 100 ml
• Lutein: max level 50 µg per 100 ml
• Sialic Acid: max level 67 mg per 100 kcal

*“Nucleotides” means 5’-monophosphate may be added to formulated milk powder for children to a maximum level of 16 mg per 100 kcal. At least four nucleotides consisting of two purine and two pyrimidine nucleotides shall be used: adenosine 5’-monophosphate, guanosine 5’- monophosphate, and inosine 5’- monophosphate (purines) and cytidine 5’-monophosphate and uridine 5’- monophosphate (pyrimidines). The purine nucleotides shall comprise a maximum of 45% of the total nucleotides added.

** Interpretation regarding the word "formulated milk powder for children" appearing under Table III of Twenty-First A Schedule for follow-up formula: 

• For follow-up formula intended for infants from 6 to 12 months, the limit for infant formula at max 5 mg per 100kcal shall be applied
• For follow-up formula intended for children from 12 months to 3 years, the limit for formulated milk powder for children at max 16 mg per 100 kcal shall be applied

Probiotic cultures specified in Twelfth A Schedule Malaysia Food Regulations are permitted. The probiotic cultures added shall remain viable and the viable probiotic count shall not be less than 10^6 cfu/ml or cfu/g during the shelf life of such food. The probiotic cultures shall not contain transmissible antibiotic-resistant genes."

Young Child Formula [6]

Formulated milk powder for children may contain: 

• Other suitable food substances including cocoa, honey, corn, soya, cereals, and fruits
• L(+) lactic acid-producing cultures
• Sucrose, glucose, fructose, glucose syrup, and dextrose as permitted sweetening substances. The total sucrose content in formulated milk powder for children shall not exceed 12 g per 100 g. For flavored variants of formulated milk powder for children, the total sucrose content shall not exceed 20 g per 100g
• Nucleotide* with maximum level at 16 mg per 100kcal
• Oligosaccharide mixture containing 90% (weight per weight) galactooligosaccharides (GOS) and 10% (weight per weight) long-chain fructooligosaccharides (lcFOS) with a maximum level of 0.8g per 100ml
• Lutein with maximum level of 50 μg per 100ml 

*“Nucleotides” means 5’-monophosphate may be added to formulated milk powder for children to a maximum level of 16 mg per 100 kcal. At least four nucleotides consisting of two purine and two pyrimidine nucleotides shall be used: adenosine 5’-monophosphate, guanosine 5’-monophosphate, and inosine 5’-monophosphate (purines) and cytidine 5’-monophosphate and uridine 5’-monophosphate (pyrimidines). The purine nucleotides shall comprise a maximum of 45% of the total nucleotides added. 

Probiotic cultures specified in Twelfth A Schedule Malaysia Food Regulations are permitted. The probiotic cultures added shall remain viable and the viable probiotic count shall not be less than 10^6 cfu/ml or cfu/g during the shelf life of such food. The probiotic cultures shall not contain transmissible antibiotic-resistant genes.

3.5 Permitted Additives

Infant Formula [4]

These additives are permitted to be used in infant formula with the maximum level based on 100 ml of the ready-to-drink product.

1. EMULSIFIERS

• Lecithin: max 0.5 g/ 100 ml
• Mono and diglycerides of edible fat and edible oil: max 0.4 g/100 ml 

2. THICKENERS 

• Guar gum: max 0.1 g/100 ml
• Locust bean gum: max 0.1 g/100 ml
• Distarch phosphate: max 0.5 g/100 ml singly or in combination in soya-based products only
• Acetylated distarch phosphate: max 2.5 g/100 ml singly or in combination in hydrolyzed protein or amino acid-based product or both
• Carrageenan: max 0.03 g/100 ml in regular milk and soya-based liquid product only; and max 0.1 g/100 ml in hydrolyzed protein or amino acid-based liquid product or both

3. ACIDULANTS, ALKALIS AND BUFFERS 

• Calcium hydroxide, Potassium hydroxide, Sodium hydrogen carbonate, Sodium carbonate, Potassium hydrogen carbonate, Potassium carbonate, Sodium citrate, Potassium citrate: limited by good manufacturing practice (GMP) and within the limits for Na and K as specified in Table I, Twenty First Schedule (max 60 mg/100 kcal and 200mg/100 kcal, respectively) 
• Lactic acid and citric acid:  limited by GMP

4. ANTIOXIDANTS 

• Tocopherols concentrate: max 1 mg/100 ml 
• L-Ascorbyl palmitate: max 1 mg/100 ml

No food additive, other than those specified above as per Table II to the Twenty First Schedule, shall be present in infant formula as a result of carryover from raw materials or other ingredients. 

Follow-up Formula [5]

These additives are permitted to be used in a follow-up formula with the maximum level based on 100 ml of the ready-to-drink product.

1. EMULSIFIERS 

• Lecithin: max 0.5 g/100 ml
• Mono and Diglycerides: max 0.4 g/100 ml

2. THICKENERS 

• Guar gum: max 0.1 g/100 ml
• Locust bean gum: max 0.1 g/100 ml
• Distarch phosphate, Acetylated distarch phosphate, Phosphated distarch phosphate, Acetylated distarch adipate: max 0.5 g/ 100 ml singly or in combination in soya-based products only; and 2.5 g/100 ml singly or in combination in hydrolyzed protein and/or amino acid-based products only
• Carrageenan: max 0.03 g/ 100 ml singly or in combination in milk and soya-based products only; and 0.1 g/ 100 ml singly or in combination in hydrolyzed protein and/or amino acid-based liquid products only 
• Pectin: max 1 g/100 ml  

3. ACIDULANTS, ALKALIS AND BUFFERS 

• Sodium hydrogen carbonate, Sodium carbonate, Sodium citrate, Potassium hydrogen carbonate, Potassium carbonate, Potassium hydroxide, Potassium citrate, Sodium hydroxide, Calcium hydroxide, L (+) lactic acid, L (+) lactic acid producing cultures, Citric acid: Limited by Good Manufacturing Practices within the limits for Na as specified in Table I, Twenty First A Schedule (max 85 mg/100 kcal)

4. ANTIOXIDANTS 

• Mixed tocopherols concentrate % - Tocopherol: max 3 mg/100 ml singly or in combination
• L-Ascorbyl palmitate: max 5 mg/100 ml singly or in combination expressed as ascorbic acid
• L-Ascorbic acid and its Na, Ca salts: max 5 mg/100 ml singly or in combination expressed as ascorbic acid

No food additive, other than those specified above as per Table II to the Twenty First A Schedule, shall be present in the follow-up formula as a result of carryover from raw materials or other ingredients.

Young Child Formula [6]

The following food additives are allowed in formulated milk powder for children: 

1. Permitted food conditioners as specified in Eleventh Schedule
2. Permitted colouring substance as specified in Seventh Schedule
3. Permitted antioxidants as follows:
   1. Mixed tocopherols concentrate or a-tocopherol, singly or in combination, not exceeding 20 mg per 100 g of milk powder 
   2. L-ascorbyl palmitate or L-ascorbic acid and its sodium or calcium salts, singly or in combination, not exceeding 33 mg per 100 g of milk powder, expressed as ascorbic acid.
      

3.6 Permitted Flavors and Colors 

Infant Formula

No flavoring allowed [4]

Follow-up Formula [5]

FLAVOURING SUBSTANCES 

• Natural Fruit Extracts: In accordance with Good Manufacturing Practices 
• Vanilla extract: In accordance with Good Manufacturing Practices
• Ethyl vanillin: max level 5 mg/100 ml of product ready for consumption
• Vanillin: max level 5 mg/100 ml of product ready for consumption

Young Child Formula [7]

Permitted flavoring substances are specified in Regulation 22 as follows: 

A) Substances which are listed in at least one of the following publications: 

• Generally Recognised As Safe (GRAS) Flavoring Substances published by the Flavor and Extract Manufacturers Association of the United States (FEMA) contained in the Food Technology, a publication of the Institute of Food Technologists; or
• Flavorings, List of Codex Specifications for Food Additives (CAC/MISC 6)

B) Natural flavoring substance either in its raw state or after processing by traditional preparation process including drying, roasting, and fermentation. 

The flavoring substances specified in Table I of Eighth Schedule of food are prohibited. These include cade oil, cocaine, nitrobenzene, and any other flavoring substance that is injurious or likely to be injurious to health. The maximum permitted proportion of certain natural toxicants in milligrams per kilogram resulting from the addition of natural flavoring substances into food is specified in Table II of Eighth Schedule: 

1. Agaric acid: 20 (mg/kg) 
2. Total hydrocyanic acid: 1 (mg/kg) 
3. Pulegone: 25 (mg/kg)
4. Quassin: 5 (mg/kg)
5. Quinine: 0.1 (mg/kg) 
6. Thujones: 0.5 (mg/kg) 
7. Aloin: 0.1 (mg/kg) 
8. Berberine: 0.1 (mg/kg) 
9. Beta-azarone: 0.1 (mg/kg) 
10. Coumarin: 2 (mg/kg) 
11. Hypericin: 0.1 (mg/kg) 
12. Safrole: 1 (mg/kg) 
13. Santonin: 0.1 (mg/kg) 
14. Rue oil: 4 (mg/kg) 
15. Spartein: 0.1(mg/kg)

Provided that where more than one of such natural toxicants are present, the amount of each shall be, such that when expressed as a percentage of the amount permitted singly, the sum of the several percentages which does not exceed one hundred.

3.7 Permitted Processing Aids 

There are no permitted processing aids specific to “Infant, Follow-up and Young Child Formula”. These products should comply with the requirements in “Section 3.0 Compositional Aspects” of the “General Foods” guidebook for Malaysia.

3.8 Additional Notes 

None

3.9 References

1. Regulation 389, Twenty First Schedule Malaysia Food Regulations

http://fsq.moh.gov.my/v6/xs/page.php?id=72

2. Regulation 389A, Twenty First A Schedule Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72

3. Regulation 91B, Sixteenth AA Schedule of Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72

4. Regulations 26 and 26A, 389; Twelfth, Twelfth A and Twenty First Schedules Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72

5. Regulations 26 and 26A, 389A; Twelfth, Twelfth A and Twenty First A Schedules Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72

6. Regulations 26 and 26A, 91B; Twelfth, Twelfth A and Sixteenth AA Schedules Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72

7. Regulations 21, 25 and 91B, Seventh and Eleventh Schedule Malaysia Food Regulations 

http://fsq.moh.gov.my/v6/xs/page.php?id=72