Document ID: chunk:federal_register_of_legislation:F2024C00897:body:0:p17
Version: federal_register_of_legislation:F2024C00897
Segment Type: other
Provision Reference: 
Character Range: 45986–48928

use in the product.
            (3)  A special medical purpose product for infants must not have a phospholipid content of more than 72 mg/100 kJ.

           2.9.1—35 Permitted novel foods

             Despite any other provision in the Code, a special medical purpose product for infants for retail sale may have, as an ingredient or a *component, a novel food, provided that the presence of that novel food in the product is necessary to achieve that product's intended medical purpose.

           2.9.1—36 Required nutritive substances

            (1) A special medical purpose product for infants must contain each substance listed in Column 1 of the table to section S29—5 in an amount (including any naturally-occurring amount) that is:

                (a) no less than the minimum amount specified in Column 2 of the table; and
                (b) no more than the maximum amount (if any) specified in Column 3 of the table.
               Note It is recommended that a special medical purpose product for infants contain a substance listed in Column 1 of the table to section S29—5 in an amount that is not more than the amount (if any) specified for that substance in Column 4 of that table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose no significant risks on the basis of current scientific knowledge. These levels are 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