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Formulae for special medical purposes for infants (13.1.3)

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
INS No. Food Additive or Group Max Level Notes Defined In
ASCORBYL ESTERS 10 mg/kg 13.1.3
1414 Acetylated distarch phosphate 5,000 mg/kg 13.1.3
526 Calcium hydroxide 2,000 mg/kg 13.1.3
290 Carbon dioxide GMP 13.1.3
410 Carob bean gum 1,000 mg/kg 13.1.3
407 Carrageenan 1,000 mg/kg 13.1.3
330 Citric acid GMP 13.1.3
472c Citric and fatty acid esters of glycerol 9,000 mg/kg 13.1
1412 Distarch phosphate 5,000 mg/kg 13.1.3
412 Guar gum 1,000 mg/kg 13.1.3
1440 Hydroxypropyl starch 5,000 mg/kg 13.1.3
270 Lactic acid, L-, D- and DL- GMP 13.1.3
322(i) Lecithin 5,000 mg/kg 13.1.3
471 Mono- and di-glycerides of fatty acids 4,000 mg/kg 13.1.3
941 Nitrogen GMP 13.1.3
1413 Phosphated distarch phosphate 5,000 mg/kg 13.1.3
501(i) Potassium carbonate 2,000 mg/kg 13.1.3
332(i) Potassium dihydrogen citrate GMP 13.1.3
501(ii) Potassium hydrogen carbonate 2,000 mg/kg 13.1.3
525 Potassium hydroxide 2,000 mg/kg 13.1.3
500(i) Sodium carbonate 2,000 mg/kg 13.1.3
331(i) Sodium dihydrogen citrate GMP 13.1.3
500(ii) Sodium hydrogen carbonate 2,000 mg/kg 13.1.3
524 Sodium hydroxide 2,000 mg/kg 13.1.3
1450 Starch sodium octenyl succinate 20,000 mg/kg 13.1.3
TOCOPHEROLS 10 mg/kg 13.1.3
332(ii) Tripotassium citrate GMP 13.1.3
331(iii) Trisodium citrate GMP 13.1.3

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


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

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