Food Categories

Food Additives

Functional Classes

Glossary

Formulae for special medical purposes for infants (13.1.3.0)

Description

Foods for special dietary use that are specially processed or formulated and presented for the dietary management of infants and may be used only under medical supervision. They are intended for the exclusive or partial feeding of infants with limited or impaired capacity to take, digest, absorb or metabolize ordinary infant formulae or certain nutrients contained therein, or who have other special medically-determined nutrient requirement, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two.¹

This page provides information on the food additive provisions that are acceptable for use in foods conforming to the food category.

This food category is listed in the Annex to Table 3. Unless specifically indicated below, food additive provisions implied by Table 3 do not automatically apply to this category.

GSFA Provisions for Food Category 13.1.3.0

INS No

Food Additive or Group

Max Level

Notes

Defined In

1414

Acetylated distarch phosphate

5000 mg/L

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

13.1.3.0

N°

1414

Food Additive or Group

Acetylated distarch phosphate

Max Level

5000 mg/L

Notes

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

ASCORBYL ESTERS

10 mg/kg

187: Ascorbyl palmitate (INS 304) only.

72: On the ready-to-eat basis.

13.1.3.0

N°

Food Additive or Group

ASCORBYL ESTERS

Max Level

10 mg/kg

Notes

187: Ascorbyl palmitate (INS 304) only.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

526

Calcium hydroxide

2000 mg/kg

55: Within the limits for sodium, calcium, and potassium specified in the Standard for Infant Formula and Formula for Special Dietary Purposes Intended for Infants (CODEX STAN 72-1981): singly or in combination with other sodium, calcium, and/or potassium salts.

72: On the ready-to-eat basis.

13.1.3.0

N°

526

Food Additive or Group

Calcium hydroxide

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

290

Carbon dioxide

GMP

59: For use as a packaging gas only.

13.1.3.0

N°

290

Food Additive or Group

Carbon dioxide

Max Level

GMP

Notes

59: For use as a packaging gas only.

Defined In

13.1.3.0

410

Carob bean gum

1000 mg/kg

72: On the ready-to-eat basis.

13.1.3.0

N°

410

Food Additive or Group

Carob bean gum

Max Level

1000 mg/kg

Notes

72: On the ready-to-eat basis.

Defined In

13.1.3.0

407

Carrageenan

1000 mg/kg

379: For use in hydrolyzed protein and/or amino acid based liquid infant formula only.

381: As consumed.

13.1.3.0

N°

407

Food Additive or Group

Carrageenan

Max Level

1000 mg/kg

Notes

379: For use in hydrolyzed protein and/or amino acid based liquid infant formula only.

381: As consumed.

Defined In

13.1.3.0

330

Citric acid

GMP

72: On the ready-to-eat basis.

13.1.3.0

N°

330

Food Additive or Group

Citric acid

Max Level

GMP

Notes

72: On the ready-to-eat basis.

Defined In

13.1.3.0

1412

Distarch phosphate

5000 mg/kg

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

13.1.3.0

N°

1412

Food Additive or Group

Distarch phosphate

Max Level

5000 mg/kg

Notes

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

412

Guar gum

1000 mg/kg

14: For use in hydrolyzed protein liquid formula only.

72: On the ready-to-eat basis.

13.1.3.0

N°

412

Food Additive or Group

Guar gum

Max Level

1000 mg/kg

Notes

14: For use in hydrolyzed protein liquid formula only.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

1440

Hydroxypropyl starch

5000 mg/kg

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

13.1.3.0

N°

1440

Food Additive or Group

Hydroxypropyl starch

Max Level

5000 mg/kg

Notes

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

270

Lactic acid, L-, D- and DL-

GMP

72: On the ready-to-eat basis.

83: L(+)-form only.

13.1.3.0

N°

270

Food Additive or Group

Lactic acid, L-, D- and DL-

Max Level

GMP

Notes

72: On the ready-to-eat basis.

83: L(+)-form only.

Defined In

13.1.3.0

322(i)

Lecithin

5000 mg/kg

72: On the ready-to-eat basis.

13.1.3.0

N°

322(i)

Food Additive or Group

Lecithin

Max Level

5000 mg/kg

Notes

72: On the ready-to-eat basis.

Defined In

13.1.3.0

471

Mono- and di-glycerides of fatty acids

4000 mg/kg

72: On the ready-to-eat basis.

13.1.3.0

N°

471

Food Additive or Group

Mono- and di-glycerides of fatty acids

Max Level

4000 mg/kg

Notes

72: On the ready-to-eat basis.

Defined In

13.1.3.0

941

Nitrogen

GMP

59: For use as a packaging gas only.

13.1.3.0

N°

941

Food Additive or Group

Nitrogen

Max Level

GMP

Notes

59: For use as a packaging gas only.

Defined In

13.1.3.0

440

Pectins

2000 mg/kg

14: For use in hydrolyzed protein liquid formula only.

72: On the ready-to-eat basis.

13.1.3.0

N°

440

Food Additive or Group

Pectins

Max Level

2000 mg/kg

Notes

14: For use in hydrolyzed protein liquid formula only.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

1413

Phosphated distarch phosphate

5000 mg/kg

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

13.1.3.0

N°

1413

Food Additive or Group

Phosphated distarch phosphate

Max Level

5000 mg/kg

Notes

150: For use in soy-based formula only.

292: Except for use in hydrolyzed protein and/or amino acid-based formula at 25 000 mg/kg.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

501(i)

Potassium carbonate

2000 mg/kg

13.1.3.0

N°

501(i)

Food Additive or Group

Potassium carbonate

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

332(i)

Potassium dihydrogen citrate

GMP

13.1.3.0

N°

332(i)

Food Additive or Group

Potassium dihydrogen citrate

Max Level

GMP

Notes

Defined In

13.1.3.0

501(ii)

Potassium hydrogen carbonate

2000 mg/kg

13.1.3.0

N°

501(ii)

Food Additive or Group

Potassium hydrogen carbonate

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

525

Potassium hydroxide

2000 mg/kg

13.1.3.0

N°

525

Food Additive or Group

Potassium hydroxide

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

500(i)

Sodium carbonate

2000 mg/kg

13.1.3.0

N°

500(i)

Food Additive or Group

Sodium carbonate

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

331(i)

Sodium dihydrogen citrate

GMP

13.1.3.0

N°

331(i)

Food Additive or Group

Sodium dihydrogen citrate

Max Level

GMP

Notes

Defined In

13.1.3.0

500(ii)

Sodium hydrogen carbonate

2000 mg/kg

13.1.3.0

N°

500(ii)

Food Additive or Group

Sodium hydrogen carbonate

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

524

Sodium hydroxide

2000 mg/kg

13.1.3.0

N°

524

Food Additive or Group

Sodium hydroxide

Max Level

2000 mg/kg

Notes

Defined In

13.1.3.0

1450

Starch sodium octenyl succinate

20000 mg/kg

376: For use in hydrolyzed protein and/or amino acid based infant formula only.

381: As consumed.

13.1.3.0

N°

1450

Food Additive or Group

Starch sodium octenyl succinate

Max Level

20000 mg/kg

Notes

376: For use in hydrolyzed protein and/or amino acid based infant formula only.

381: As consumed.

Defined In

13.1.3.0

TOCOPHEROLS

10 mg/kg

416: Tocopherol concentrate, mixed (INS 307b) only.

72: On the ready-to-eat basis.

13.1.3.0

N°

Food Additive or Group

TOCOPHEROLS

Max Level

10 mg/kg

Notes

416: Tocopherol concentrate, mixed (INS 307b) only.

72: On the ready-to-eat basis.

Defined In

13.1.3.0

332(ii)

Tripotassium citrate

GMP

13.1.3.0

N°

332(ii)

Food Additive or Group

Tripotassium citrate

Max Level

GMP

Notes

Defined In

13.1.3.0

331(iii)

Trisodium citrate

GMP

13.1.3.0

N°

331(iii)

Food Additive or Group

Trisodium citrate

Max Level

GMP

Notes

Defined In

13.1.3.0

415

Xanthan gum

1000 mg/kg

381: As consumed.

479: In powdered hydrolysed protein and/or amino acid based infant formula only.

13.1.3.0

N°

415

Food Additive or Group

Xanthan gum

Max Level

1000 mg/kg

Notes

381: As consumed.

479: In powdered hydrolysed protein and/or amino acid based infant formula only.

Defined In

13.1.3.0

Showing 1 to 29 of 29 entries

Note: Items in uppercase (e.g. PHOSPHATES) refer to food additive groups.

Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CODEX STAN 180-1991).