13.1.1 Special medical purpose product for infants

ANZ food category, from Australia New Zealand Food Standards Code, Schedule 15.

Schedule 15 is hierarchical: under S15—2, a permission for a class of food also applies to the classes listed beneath it. So this page lists the additives permitted for this category directly, and then those permitted for the broader categories that contain it. A condition on a broader category's permission ("only nut butters and nut spreads") still applies here.

Provided for this category

AdditiveMaximum levelConditionsCitation
Acetylated distarch adipate E142225,000 mg/L

Note 5: Additive 1422 may only be used in a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1413 and 1414. Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1422
Acetylated distarch phosphate E141425,000 mg/L

Note 4: Additive 1414 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1413 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1413 and 1422. Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1414
Ascorbyl palmitate E304100 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 304
Calcium carbonate E170GMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 170
Calcium citrate E333GMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 333
Calcium hydrogen phosphate E341450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 341
Calcium phosphate E341450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 341
Carob bean gum E4105,000 mg/L

Only in a product specifically formulated for reduction of gastro-oesophageal reflux. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 410
Carrageenan E4071,000 mg/L

Only in a liquid product that contain hydrolysed proteins and/or amino acids. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 407
Diacetyltartaric and fatty acid esters of glycerol E472e400 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 472e
Dipotassium phosphate E340450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 340
Disodium phosphate E339450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 339
Distarch phosphate E141225,000 mg/L

Note 2: Additive 1412 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1413, 1414 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1413, 1414 and 1422. Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1412
Guar gum E41210,000 mg/L

Note 1: Additive 412 may only be used in a product that contains one or more of the following: hydrolysed proteins; peptides; amino acids. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 412
Hydroxypropyl starch E144025,000 mg/L

Note 6: Additive 1440 may only be used in a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1413, and 1414. Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1440
Mono- and di-glycerides of fatty acids E4715,000 mg/L

Only in product formulated for diets devoid of proteins. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 471
Monobasic calcium phosphate E341450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 341
Pectins E4402,000 mg/L; 5,000 mg/L

Only in a liquid product that contain hydrolysed protein. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. Only in a product formulated for infants with gastro-intestinal disorders. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 440
Phosphated distarch phosphate E141325,000 mg/L

Note 3: Additive 1413 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1414 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1414 and 1422. Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1413
Phosphoric acid E338450 mg/L

For pH adjustment only. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 338
Potassium dihydrogen phosphate INS 340(i)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 340
Sodium acid phosphate INS 339(i)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 339
Sodium alginate E4011,000 mg/L

Only in a product specifically formulated for both the dietary management of metabolic disorders of infants aged 4 months and above and general tube-feeding of infants aged 4 months and above. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 401
Starch sodium octenyl succinate E145020,000 mg/L

Note 7: Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 1450
Tripotassium phosphate INS 340(iii)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 340
Trisodium phosphate INS 339(iii)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 339
Xanthan gum E4151,200 mg/L

Only in a product that is based on hydrolysed protein, amino acids or peptides. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1.1, INS 415

Provided for broader categories

These apply here through the hierarchy, subject to their own notes and conditions. Where an additive is also provided for this category directly, it is marked; the direct provision is listed above.

13.1 Infant formula products — 46 additives
AdditiveMaximum levelConditionsCitation
Acetylated distarch adipate (also provided directly)5,000 mg/L

Note 5: Additive 1422 may only be used in soy based follow-on formula, either singly or in combination with one or more of additives 1412, 1413 and 1414. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1422
Acetylated distarch phosphate (also provided directly)5,000 mg/L

Note 4: Additive 1414 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1412, 1413, and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1412, 1413, and 1422. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1414
Ascorbic acid50 mg/L

Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 300
Ascorbyl palmitate (also provided directly)50 mg/L; 10 mg/L

Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 304
Calcium ascorbate50 mg/L

Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 302
Calcium citrate (also provided directly)0.1 mg/L

As calcium, may only be added as part of a nutrient preparation. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 333
Calcium hydroxide2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 526
Carob bean gum (also provided directly)1,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 410
Carrageenan (also provided directly)300 mg/L

Only in a liquid product. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 407
Citric acidGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 330
Citric and fatty acid esters of glycerol7,500 mg/L; 9,000 mg/L

Only in a powdered product. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. Only in a liquid product. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 472c
Delta-tocopherol10 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 309
Dipotassium phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 340
Disodium phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 339
Distarch phosphate (also provided directly)5,000 mg/L

Note 2: Additive 1412 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1413, 1414 and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1413, 1414 and 1422. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1412
dl-alpha-Tocopherol10 mg/L; 30 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 307c
Gamma-tocopherol10 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 308
Guar gum (also provided directly)1,000 mg/L

Only in a liquid product that contains hydrolysed protein. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 412
Gum arabic (Acacia gum)10 mg/L

May only be added as part of a nutrient preparation. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 414
Hydroxypropyl starch (also provided directly)5,000 mg/L

Note 6: Additive 1440 may only be used in soy based infant formula product (other than follow-on formula), either singly or in combination with one or more of additives 1412, 1413, and 1414. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1440
Lactic acidGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 270
Lecithin5,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 322
Mono- and di-glycerides of fatty acids (also provided directly)4,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 471
Pectins (also provided directly)10,000 mg/L

Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 440
Phosphated distarch phosphate (also provided directly)5,000 mg/L

Note 3: Additive 1413 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1412, 1414 and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1412, 1414 and 1422. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1413
Phosphoric acid (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 338
Potassium bicarbonate2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 501
Potassium carbonate2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 501
Potassium citratesGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 332
Potassium dihydrogen citrateGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 332
Potassium dihydrogen phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 340
Potassium hydroxide2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 525
Silicon dioxide10 mg/L

May only be added as part of a nutrient preparation. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 551
Sodium acid phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 339
Sodium ascorbate50 mg/L; 75 mg/L

Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. May only be added to polyunsaturated fatty acid preparations. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 301
Sodium bicarbonate2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 500
Sodium carbonate2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 500
Sodium citrateGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 331
Sodium citratesGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 331
Sodium dihydrogen citrateGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 331
Sodium hydroxide2,000 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 524
Starch sodium octenyl succinate (also provided directly)100 mg/L; 1,000 mg/L

May only be added as part of a nutrient preparation. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. May only be added to polyunsaturated fatty acid preparations. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 1450
Tocopherol concentrate, mixed10 mg/L; 30 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard. Note 1: For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 307b
Tripotassium citrateGMP

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 332
Tripotassium phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 340
Trisodium phosphate (also provided directly)450 mg/L

Applies in Australia; New Zealand has not adopted Standard 2.9.1 (infant formula products) and applies its own infant formula standard.

Food Standards Code, Schedule 15, S15—5, item 13.1, INS 339