Singapore legislation

Regulation 252

of Food Regulations

Regulation 252

Infant formula

Amended byS 195/2011 wef 15/04/2011S 195/2011 wef 15/04/2011S 493/2013 wef 01/08/2013S 49/2016 wef 02/02/2016S 195/2011 wef 15/04/2011S 152/2017 wef 01/04/2017S 152/2017 wef 01/04/2017S 146/2018 wef 28/03/2018S 146/2018 wef 28/03/2018S 425/2024 wef 31/05/2024S 146/2018 wef 28/03/2018S 695/2021 wef 01/10/2021S 695/2021 wef 01/10/2021S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024S 580/2019 wef 01/09/2019

Subregulation 1

Infant formula shall be any food described or sold as an alternative to human milk for the feeding of infants. It shall be a product prepared from milk of cows or other animals or both or from other edible constituents of animals, including fish, or plants and which have been proved suitable for infant feeding.

Subregulation 2

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 litre of the product ready for consumption.

Subregulation 3

Amended byS 195/2011 wef 15/04/2011S 195/2011 wef 15/04/2011

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

(a)

not less than 1.8 g and not more than 4 g protein of nutritional quality equivalent to that of casein or 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;

(b)

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;

(c)

not less than 75 mcg and not more than 150 mcg Vitamin A expressed as retinol;

(d)

not less than 40 and not more than 100 I.U. of Vitamin D;

(e)

not less than 8 mg Vitamin C (ascorbic acid);

(f)

not less than 40 mcg Vitamin B1 (thiamine);

(g)

not less than 60 mcg Vitamin B2 (riboflavin);

(h)

not less than 250 mcg nicotinamide;

(i)

not less than 35 mcg Vitamin B6. Formulae with a higher protein content than 1.8 g protein/100 kcal shall contain a minimum of 15 mcg Vitamin B6 per gram protein;

(j)

not less than 4 mcg folic acid;

(k)

not less than 300 mcg pantothenic acid;

(l)

not less than 0.15 mcg Vitamin B12;

(m)

not less than 4 mcg Vitamin K1;

(n)

not less than 1.5 mcg Vitamin H (Biotin);

(o)

not less than 0.7 I.U. Vitamin E (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;

(p)

not less than 20 mg and not more than 60 mg sodium (Na);

(q)

not less than 80 mg and not more than 200 mg potassium (K);

(r)

not less than 55 mg and not more than 150 mg chloride (Cl);

(s)

not less than 50 mg calcium (Ca) and the Calcium: Phosphorus (Ca:P.) ratio shall be not less than 1.2 and not more than 2.0;

(t)

not less than 25 mg of phosphorus (P) and the Calcium: Phosphorus (Ca:P.) ratio shall be not less than 1.2 and not more than 2.0;

(u)

not less than 6 mg magnesium (Mg);

(v)

not less than 0.15 mg iron (Fe);

(w)

not less than 5 mcg iodine (I);

(x)

not less than 60 mcg copper (Cu);

(y)

not less than 0.5 mg zinc (Zn); (z)not less than 5 mcg manganese (Mn); and

(za)not less than 1 mcg and not more than 5 mcg selenium (Se).

Subregulation 4

For the purpose of calculating the number of kilocalories supplied by a food referred to in this regulation —

(a)

1 g of any fat in that food shall be deemed to supply 9 kcal;

(b)

1 g of any protein in that food shall be deemed to supply 4 kcal;

(c)

1 g of any carbohydrate in that food shall be deemed to supply 4 kcal.

Subregulation 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, only in amounts necessary for that purpose. Only natural L-forms of amino acids shall be used.

Subregulation 6

Amended byS 493/2013 wef 01/08/2013S 49/2016 wef 02/02/2016S 195/2011 wef 15/04/2011S 152/2017 wef 01/04/2017S 152/2017 wef 01/04/2017S 146/2018 wef 28/03/2018S 146/2018 wef 28/03/2018S 425/2024 wef 31/05/2024S 146/2018 wef 28/03/2018S 695/2021 wef 01/10/2021S 695/2021 wef 01/10/2021S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024S 425/2024 wef 31/05/2024

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:

(a)

Nucleotides listed below, provided that the total level of nucleotides (including added and endogenous nucleotides) shall not exceed 16 mg per 100 kcal:

(i)

Cytidine 5’-Monophosphate;

(ii)

Uridine 5’-Monophosphate;

(iii)

Adenosine 5’-Monophosphate;

(iv)

Guanosine 5’-Monophosphate; and

(v)

Inosine 5’-Monophosphate;

(b)

Long chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) but their content shall not exceed —

(i)

1% of the total fat content for n-3 LCP; and

(ii)

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; (c)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; (d)Polydextrose, in an amount not exceeding a total level of 0.2 g per 100 ml;

(e)

Bovine lactoferrin, in an amount not exceeding 100mg per 100ml;

(f)

Beta-palmitin, with at least 52% of total palmitic acid esterified at the beta position, in an amount not exceeding 80% of the total fat content of infant formula;

(g)

2’‑fucosyllactose, in an amount not exceeding 240 mg per 100 ml; (h)Lacto‑N‑neotetraose, in an amount not exceeding 60 mg per 100 ml;

(i)

2’‑fucosyllactose/difucosyllactose mixture that contains at least 75% (w/w) 2’‑fucosyllactose and 5% (w/w) difucosyllactose, and that is —

(i)

in the case of infant formula for an infant of or below 6 months of age — in an amount not exceeding 160 mg per 100 ml; or

(ii)

in the case of infant formula for an infant above the age of 6 months but not more than 12 months of age — in an amount not exceeding 120 mg per 100 ml;

(j)

Lacto-N-tetraose, in an amount not exceeding 80 mg per 100 ml;

(k)

Sodium salt of 3’-sialyllactose, but only if the amount of 3’-sialyllactose does not exceed —

(i)

in the case of infant formula for an infant of or below 6 months of age — 20 mg per 100 ml; or

(ii)

in the case of infant formula for an infant above the age of 6 months but not more than 12 months of age — 15 mg per 100 ml;

(l)

Sodium salt of 6’-sialyllactose, but only if the amount of 6’-sialyllactose does not exceed —

(i)

in the case of infant formula for an infant of or below 6 months of age — 40 mg per 100 ml; or

(ii)

in the case of infant formula for an infant above the age of 6 months but not more than 12 months of age — 30 mg per 100 ml;

(m)

3-fucosyllactose, in an amount not exceeding 44 mg per 100 ml.

Subregulation 7

Amended byS 580/2019 wef 01/09/2019

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

Subregulation 8

[Deleted by S 195/2011 wef 15/04/2011]

Subregulation 9

[Deleted by S 195/2011 wef 15/04/2011]