Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p18
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 48676–51974

values derived on the basis of meeting nutritional requirements of infants and an established history of apparent safe use. These Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of a special medical purpose product for infants or due to technological reasons.
            (2) The ratio of calcium to phosphorus in a special medical purpose product for infants must be no less than 1 to 1 and no more than 2 to 1.

           2.9.1—37 Optional nutritive substances

             A substance listed in Column 1 of the table to section S29—7 may be *used as a nutritive substance in a special medical purpose product for infants, provided that the amount of the substance in the product (including any naturally-occurring amount) is:

               (a) no less than the minimum amount (if any) specified in Column 2 of the table; and
                (b) no more than the maximum amount specified in Column 3 of the table.

           2.9.1—38 Required forms for nutritive substances

              A substance used in a special medical purpose product for infants in accordance with section 2.9.1—36 or 2.9.1—37 must be in a permitted form listed in:

               (a) if a vitamin, mineral or electrolyte—the table to section S29—23; and
                (b) in any other case— the table to section S29—9.

           2.9.1—39 Addition of lactic acid producing microorganisms

             L(+) lactic acid producing microorganisms may be added to a special medical purpose product for infants.

           2.9.1—40 Restriction on addition of inulin-type fructans and galacto‑oligosaccharides

             If an *inulin-type fructan or a *galacto-oligosaccharide is added to a special medical purpose product for infants, the product must contain (taking into account both the naturally‑occurring and added substances) no more than:

               (a) if only inulin-type fructans are added—110 mg/100 kJ of inulin-type fructans; or
               (b) if only galacto-oligosaccharides are added—290 mg/100 kJ of galacto-oligosaccharides; or
               (c) if both inulin-type fructans and galacto-oligosaccharides are added:
                   (i) no more than 110 mg/100 kJ of inulin-type fructans; and
                   (ii) no more than 290 mg/100 kJ of combined inulin-type fructans and galacto-oligosaccharides.

           2.9.1—41 Restriction on levels of other substances

             A special medical purpose product for infants must not contain any of the following:

               (a) detectable gluten; or
               (b) more than 3.8 mg/100 kJ of free nucleotide-5′-monophosphates.

               Note 1 Section S19—4 contains the maximum levels (ML) of  contaminants in infant formula products.
               Note 2 Standard 1.3.1 and Schedule 15 permit the use of certain substances as food additives in infant formula products including a special medical purpose product for infants.

           2.9.1—42 Permitted variation from compositional requirements

            (1) A special medical purpose product for infants need not comply with a compositional requirement to the extent that a variation from that requirement:

               (a) is necessary to achieve