Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p16
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 43520–46346

one or more of the following proteins: cow milk; goat milk; sheep milk; a partially hydrolysed protein of one or more of cow milk, goat milk and sheep milk.

            (4) The L-amino acids listed in the table to section S29—3 must be present in a special medical purpose product for infants at a level not less than the corresponding minimum level specified in the table.

            (5) The minimum levels specified in the table to section S29—3 for cysteine and for methionine do not apply if:

               (a)  the minimum amount of combined cysteine and methionine in the special medical purpose product for infants is not less than 15 mg per 100 kJ; and

               (b) the ratio of methionine to cysteine in the special medical purpose product for infants is less than 2 to 1.

            (6) The minimum levels specified in the table to section S29—3 for phenylalanine and for tyrosine do not apply if:

               (a)  the minimum amount of combined phenylalanine and tyrosine in the special medical purpose product for infants is not less than 37 mg per 100 kJ; and

               (b) the ratio of tyrosine to phenylalanine in the 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