3.0 Compositional Aspects

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Infant, Follow-up, and Young Child Formula
Singapore

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

Infant Formula and Follow-up Formula [1]

Infant formula prepared in accordance with the directions on the label shall have an energy value of not less than 640 kcal and not more than 720 kcal per liter of the product ready for consumption.

Infant formula shall contain per 100 kcal of intake the following:

Protein: not less than 1.8 g and not more than 4 g of protein of nutritional quality equivalent to that of casein or a greater quantity of other protein in proportion to its nutritional quality. The quality of the protein shall not be less than 85% of that of casein;
Fat: not less than 3.3 g and not more than 6 g fat and not less than 0.3 g linoleic acid in the form of glycerides;
Vitamin A: 75 - 150 mcg (expressed as retinol)
Vitamin D: 40 - 100 I.U
Vitamin C: not less than 8 mg (ascorbic acid)
Vitamin B1: not less than 40 mcg (thiamine)
Vitamin B2: not less than 60 mcg (riboflavin)
Nicotinamide: not less than 250 mcg;
Vitamin B6: not less than 35 mcg. Formulae with a higher protein content than 1.8 g protein/100 kcal shall contain a minimum of 15 mcg of Vitamin B6 per gram protein;
Folic acid: not less than 4 mcg
Pantothenic acid: not less than 300 mcg
Vitamin B12: not less than 0.15 mcg
Vitamin K1: not less than 4 mcg
Vitamin H: not less than 1.5 mcg (Biotin)
Vitamin E: not less than 0.7 I.U. (d-tocopherol compounds) per g linoleic acid (or per g polyunsaturated fatty acids, expressed as linoleic acid) but in no case less than 0.7 I.U./ 100 kcal
Sodium (Na): 20 - 60 mg
Potassium (K): 80 - 200 mg
Chloride (Cl): 55 – 150 mg
Calcium (Ca): not less than 50 mg.
Phosphorus (P): not less than 25 mg
The Calcium: Phosphorus (Ca: P) ratio shall be not less than 1.2 and not more than 2.0
Magnesium (Mg): not less than 6 mg
Iron (Fe): not less than 0.15 mg
Iodine (I): not less than 5 mcg
Copper (Cu): not less than 60 mcg
Zinc (Zn): not less than 0.5 mg
Manganese (Mn): not less than 5 mcg
Selenium (Se): 1 - 5 mcg

Young Child Formula [2]

There is no official food category set forth by the Singapore Food Regulation for formulated milk products for young children from 12 months up to 36 months. "Young child formula" can be classified under "Special purpose foods" as “formulated food for young children" based on its target group of consumers. In general, food manufacturers should ensure that the nutrients added to food products for specific populations are at levels safe and suitable for consumption by the target group of consumers. Regulation 11(4) of the Food Regulations would apply to young child formula classified under "special purpose food":

When vitamin A or vitamin D or a mineral is added to a food, the addition must not increase the vitamin A content to more than 750 mcg of retinol activity per (i) 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder OR (ii) solid food not specified 120g;
Nor increase the content of vitamin D to more than 10 mcg of cholecalciferol;
Or of any mineral to more than 3 times the daily allowance (as specified in Table I for that mineral) per 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder.

3.2 Raw Material Requirements

Infant, Follow-up, and Young Child Formula [3]

The main ingredient in the product is milk. Milk is defined under Regulation 93 as follows:

Milk shall be the normal mammary secretion of cows, buffaloes, or goats without either addition thereto or extraction therefrom and shall contain:

not less than 8.5% (w/w) milk solids other than milk fat;
not less than 3.25% (w/w) milk fat; and
no added water, dried or condensed milk, or any fluid reconstituted therefrom, or any skimmed milk, coloring matter, or any other substance added.

The purity of permitted food additives shall conform with the specifications as recommended by the Joint Food and Agriculture Organisation of the United Nations and World Health Organisation (FAO/WHO) Expert Committee on food additives. For other raw materials, it is not mentioned by the Singapore Food Regulation.

3.3 Fortification

Infant, Follow-up, and Young Child Formula [4]

All permitted nutrient supplements are specified in the Seventh Schedule of Singapore Food Regulation.

3.4 Other Permitted Ingredients

Infant Formula and Follow-up Formula [1][5]

Isolated amino acids may be added to infant formula only to improve its nutritional value. Essential amino acids may be added to improve protein quality, but only in amounts necessary for that purpose. Only natural L-forms of amino acids shall be used.

The following ingredients may be added to infant formula in order to provide substances ordinarily found in human milk and to ensure that the formulation is suitable as the sole source of nutrition for the infant or to provide other benefits that are similar to outcomes of populations of breastfed babies:

Nucleotides, Cytidine 5’-Monophosphate; Uridine 5’-Monophosphate; Adenosine 5’-Monophosphate; Guanosine 5’-Monophosphate; and Inosine 5’-Monophosphate: the total level of nucleotides, including added and endogenous nucleotides, shall not exceed 16 mg per 100 kcal;
Long chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) but their content shall not exceed 1% of the total fat content for n-3 LCP, and 2% of the total fat content for n-6 LCP (1% of the total fat content for arachidonic acid), and the eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content;
Galacto-oligosaccharides, long-chain inulin, and oligofructose are produced from inulin, in an amount not exceeding a total level of 0.8 g per 100 ml;
Polydextrose: max 0.2 g/100 ml;
Bovine lactoferrin: max 100mg/100ml;
Beta-palmitin (with at least 52% of total palmitic acid esterified at the beta position): max 80% of the total fat content of infant formula;
2’ fucosyllactose: max120 mg/100 ml;
Lacto N neotetraose: max 60 mg/100 ml;
2’-fucosyllactose/difucosyllactose mixture that contains at least 75% (w/w) 2’-fucosyllactose and 5% (w/w) difucosyllactose: max 160 mg/ 100 ml (infant formula for an infant of or below 6 months of age)
Lacto-N-tetraose: max 80 mg/100 ml (infant formula for an infant of or below 6 months of age)

According to the feedback of SFA in Frequently Asked Questions on Infant Formula, probiotics can be added.

Young Child Formula [6]

Special-purpose foods may contain permitted amino acids and other nutrient supplements (listed under fortification according to the Seventh Schedule of the Food Regulations).

3.5 Permitted Additives

Infant Formula, Follow-up Formula [7]

E 412 Guar gum; E 410 Carob bean gum (Locust bean gum); E 1412 Distarch phosphate; E 1414 Acetylated distarch phosphate; E 1413 Phosphated distarch phosphate; E 1440 Hydroxypropyl starch; E 407 Carrageenan; E 1450 Starch sodium octenyl succinate; E 322(i) Lecithin; E 471 Mono- and diglycerides; E 472c Citric and fatty acid esters of glycerol; E 524 Sodium hydroxide; E 500(ii) Sodium hydrogen carbonate; E 500(i) Sodium carbonate ; E 525 Potassium hydroxide; E 501(ii) Potassium hydrogen carbonate; E 501(i) Potassium carbonate; E 526 Calcium hydroxide; E 270 L(+) lactic acid; E 330 Citric acid; E 331(i) Sodium dihydrogen citrate; E 331(iii) Trisodium citrate; E 332 Potassium citrate; E 339(i), 339(ii) and 339(iii) Sodium dihydrogen phosphate, disodium hydrogen phosphate and trisodium phosphate; E 340(i), 340(ii) and 340(iii) Potassium dihydrogen phosphate, dipotassium hydrogen phosphate and tripotassium phosphate; INS 307 E 306 Mixed tocopherol concentrate; E 304(i) Ascorbyl palmitate; E 290 Carbon dioxide; E 941 Nitrogen.

New food additive provisions effective from 19 January 2021: Sodium salts of 3'-sialyllactose (3'-SL) and 6'- sialyllactose (6'-SL).

Limitations:

Sodium salt of 3’-SL: 0.2 g/L (expressed as 3’-SL; in the case of formulas for infants aged 0 – 6 months)
Sodium salt of 6’-SL: 0.4 g/L (expressed as 6’-SL; in the case of formulas for infants aged 0 – 6 months)

Young Child Formula [8]

Permitted General Purpose Food Additives in the regulations are allowed to be added.

3.6 Permitted Flavors and Colors

Infant Formula, Follow-up Formula [9][10]

Flavoring agents do not include substances that impart a sweet taste to food; such substances would be regulated as sweetening agents under the Food Regulations. In principle, SFA has no objection to the use of flavoring substances that have been evaluated and endorsed by recognized international bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Flavour and Extract Manufacturers’ Association (FEMA), or the European Food Safety Authority (EFSA), under good manufacturing practice (GMP), provided that the flavoring preparations do not contain any of the prohibited substances listed under Regulation 22(7) of the Food Regulations. Regulation 22(7) prohibits the use of coumarin, tonka bean, safrole, sassafras oil, dihydrosafrole, isosafrole, agaric acid, nitrobenzene, dulcamara, pennyroyal oil, oil of tansy, rue oil, birch tar oil, cade oil, volatile bitter almond oil containing hydrocyanic acid and male fern as flavoring agents.

Natural or synthetic flavoring essence or extract must be contained in a permitted solvent, namely, 1,3-propanediol, benzyl alcohol, beta-cyclodextrin, diacetin, diethyl ether, ethyl acetate, ethyl alcohol, glycerol, isopropyl alcohol, propylene glycol, triacetin, and water. The permitted solvents other than water shall conform with the British Pharmacopoeia standard. Permitted Emulsifier compounds may also be carried in an emulsion of a permitted emulsifier as provided under Regulation 21, Sixth Schedule with any of the permitted solvents mentioned. Also, those emulsifiers must also be permitted for use in infant formulas, which are:

Citric acid glycerides;
Carrageenan;
Carob bean gum; guar gum;
Lecithin;
Distarch phosphate, Acetylated distarch phosphate, Hydroxypropyl starch, Starch sodium octenyl succinate;
Mono and diglycerides of fatty acids;
Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Trisodium phosphate, Potassium dihydrogen phosphate, Dipotassium hydrogen phosphate, Tripotassium phosphate.

Young Child Formula [9][10]

Natural or synthetic flavoring essence or extract must be contained in a permitted solvent, namely, 1,3-propanediol, benzyl alcohol, beta-cyclodextrin, diacetin, diethyl ether, ethyl acetate, ethyl alcohol, glycerol, isopropyl alcohol, propylene glycol, triacetin, and water. The permitted solvents other than water shall conform with the British Pharmacopoeia standard. Permitted flavoring compounds may also be carried in an emulsion of a permitted emulsifier as provided under Regulation 21, Sixth Schedule with any of the permitted solvents mentioned.

3.7 Permitted Processing Aids

Singapore refers to Codex for processing aids. According to Codex Guidelines on Substances Used as Processing Aids (CAC/GL 75-2010) [11], processing aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.

The usage of the processing aids shall comply with the Codex Guidelines on Substances Used as Processing Aids (CAC/GL 75-2010).

3.8 Additional Notes

In the case of infant formula that is sold or to be sold as infant/follow-up formula that is lactose-free, low lactose, or words of similar import, the total lactose content must not be greater than 10 mg per 100 kcal.