3. Compositional Aspects

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3. 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

Category

Special Purpose Foods [1]

There are no composition requirements for the overall category of “Special Purpose Foods”. Refer to the below paragraphs on specific product composition.

Product

1) Infant 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

2) Follow-up Formula

Same as Infant Formula composition requirements above for the age range from 0 to 12 months.

3) Young Child Formula [2]

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, 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 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder 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: calcium maximum limit 2,400mg, iodine maximum limit 300mcg, iron maximum limit 30mg, phosphorus maximum limit 2,400mg.

3.2 Raw Material Requirements

Category

Special purpose foods [3]

For products containing milk, Regulation 93 has to be followed:

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 Organization 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. Notwithstanding, it would be recommended to follow the specifications of other individual raw materials where stipulated in the Singapore Food Regulation.

It is also not permitted to use any edible fat or oil that contains any partially hydrogenated oil as an ingredient in the manufacture of any other edible fat or oil or any prepacked food according to Regulation 36A of the Singapore Food Regulation.

Product

Infant Formula, Follow-on Formula, Young Child Formula

There are no requirements specific to these products. Same as "Category" (special purpose foods) above.

3.3 Fortification

Category

Special purpose foods [4]

Permitted nutrient supplements are specified in the Seventh Schedule of Singapore Food Regulations for vitamins, minerals, and amino acids.

3.4 Other Permitted Ingredients

Category

Special purpose foods [4]

Aside from vitamins, minerals, and amino acids that are permitted to be added (listed in Section 3.3 above), special purpose foods may also add any other raw materials or ingredients suitable for human consumption if they possess nutritive and assimilative properties which render it especially suitable for use as food by these persons requiring the special diet. There are no specific compositional criteria for the overall category.

Product

1) Infant Formula and Follow-on 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 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: max 240 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); or max 120 mg/ 100 ml (infant formula for an infant above the age of 6 months but not more than 12 months of age);
- Lacto-N-tetraose: max 80 mg/100 ml
- Sodium salt of 3’-sialyllactose: max 20 mg/ 100 ml (infant formula for an infant of or below 6 months of age); or max 15 mg/ 100 ml (infant formula for an infant above the age of 6 months but not more than 12 months of age);
- Sodium salt of 6’-sialyllactose: max 40 mg/ 100 ml (infant formula for an infant of or below 6 months of age); or max 30 mg/ 100 ml (infant formula for an infant above the age of 6 months but not more than 12 months of age);
- 3’-fucosyllactose: max 44 mg/ 100 ml
According to the feedback of SFA in Frequently Asked Questions on Infant Formula, probiotics can be added. [5]

2) 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

Category

Special purpose foods [7,8]

Permitted additives for this category follow the Sixth Schedule on permitted emulsifiers and stabilizers, Eighth Schedule on general-purpose food additives, and Thirteenth Schedule on permitted sweeteners with specified limits under the category ‘Special purpose medical foods (excluding products for infants)’ in the Food Regulations.

Product

1) Infant Formula and Follow-on Formula [9]

Food additives permitted for use in infant formula are listed in Part C [9].

2) Young Child Formula [7]

Permitted general-purpose food additives are listed in Regulation 28 and the Eighth Schedule of the Food Regulations [7].

Any food (including young child formula) shall not contain residue of acetone unless —

in the case of flavoring, where acetone is used as a processing aid in the production of the flavoring, the residue of acetone does not exceed 5 mg/kg of the flavoring; or
in the case of any food or any food containing flavoring, where acetone is used as a processing aid in the production of the food or in the production of one or more of its ingredients, the residue of acetone does not exceed 0.1 mg/kg of the food.

Methanol may be used as an extraction solvent in food, provided that the residue of methanol in the food does not exceed 5 ppm.

*Permitted enzymes in EIGHTH Schedule, Singapore Food Regulation

3.6 Permitted Flavors and Colors

Category

Special purpose foods

Permitted colors are listed in Regulation 20, FIFTH Schedule of the Food Regulations [10]. 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 Flavor 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 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. Refer to the Sixth Schedule for the list of permitted emulsifiers and stabilizers [8,11].

Product

1) Infant Formula and Follow-on Formula [9]

Flavors and Colors are prohibited in Infant Formula and Follow-up Formula as they are excluded from the list of permitted additives in Regulation 252 and Section 3.5 above.

2) Young Child Formula [8,10,11]

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. Young child formula should comply with the use of permitted colors and flavorings under Section 3.6 for the category “special purpose foods.

3.7 Permitted Processing Aids

Category

Special purpose foods [12]

In the absence of a definition for “processing aids” under the Food Regulations, the current definition as stipulated in the Codex Procedural Manual may be taken as a reference according to the SFA Guide on Food Labeling and Advertisements [13]:

“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.”

Processing aids may be used in the manufacture of food products provided that:

the use of processing aids complies with the Codex Guidelines on Substances Used as Processing Aids (CAC/GL 75-2010) [14]; and
the processing aids do not migrate any harmful substances to the finished product.

Product

Infant Formula, Follow-on Formula, Young Child Formula

There are no requirements specific to these products. It should comply with the requirements under "Category" (special purpose foods) above.

3.8 Additional Notes

Product

Infant Formula and Follow-up Formula [1]

In the case of infant formula that is sold or to be sold as infant 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.