Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p17
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 46096–48931

of a special medical purpose product for infants or due to technological reasons.
               (d) have an arachidonic acid (20 to 4 n-6) content of equal to or more than docosahexaenoic acid (22 to 6 n-3) content; and
               (e) contain no less than 0.5 mg of vitamin E per gram of polyunsaturated fatty acids; and
               (f) for any long chain *polyunsaturated fatty acids that are present in the product—have an eicosapentaenoic acid (20 to 5 n-3) content of no more than the docosahexaenoic acid (22 to 6 n-3) content; and
               (g) for a fatty acid listed in Column 1 of the table to section S29—4 and present in the product—contain not more than the maximum amount (if any) specified in Column 2 of the table for that fatty acid.
            (2)  A special medical purpose product for infants may only contain medium chain triglycerides that are:
               (a) a natural constituent of a milk-based ingredient of that product; or
               (b) for a fat soluble vitamin that is specified in the table to section S29—5—a substance that was *used as a processing aid in the preparation of that permitted fat soluble vitamin for 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