Document ID: chunk:federal_register_of_legislation:F2024C00897:body:0:p16
Version: federal_register_of_legislation:F2024C00897
Segment Type: other
Provision Reference: 
Character Range: 43384–46265

special medical purpose product for infants is less than 2 to 1.

            (7) Despite subsections (4), (5) and (6), L-amino acids listed in the table to section S29—3 must only be added to a special medical purpose product for infants in an amount necessary to improve protein quality.

           2.9.1—34 Fat requirements

            (1) A special medical purpose product for infants must:

               (a) have a fat content of no less than 1.1 g/100 kJ and no more than
              1.4 g/100 kJ; and
               (b) have a ratio of linoleic acid to α-linolenic acid of no less than 5 to 1 and no more than 15 to 1; and
               (c) contain no less than:
                  (i)                   90 mg/100 kJ of linoleic acid; and
                  (ii)                 12 mg/100 kJ of α-linolenic acid; and
                   Note.   It is recommended that a special medical purpose product for infants contain not more than 335 mg/100 kJ of linoleic acid. This amount is a Guidance Upper Level and a recommended upper level for this nutrient which poses 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. This Guidance Upper Level should not be exceeded unless a higher nutrient level cannot be avoided due to high or variable contents in constituents 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