Division 1Preliminary

Division 1 – Preliminary

1 Definition of food for special medical purposes

(1) Subject to subclause (2), a food is a food for special medical purposes if the food is –

(a) specially formulated for the dietary management of individuals –

  (i) by way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food; and
  (ii) whose dietary management cannot be completely achieved without the use of the food; and

(b) intended to be used under medical supervision; and
(c) represented as being a food for special medical purposes or for the dietary management of a disease, disorder or medical condition.

(2) A food is not a food for special medical purposes if the food is –

(a) formulated and represented as being for the dietary management of obesity or overweight; or
(b) an infant formula product as defined in Standard 2.9.1.

Note: Example:

Note: An infant formula product specifically formulated to satisfy metabolic conditions (refer Subdivision 2 of Division 3 of Standard 2.9.1) is excluded from the definition of a food for special medical purposes, even if the infant formula product satisfies the requirements of paragraphs (1)(a),(b) and (c), and will not be regulated by Standard 2.9.5.

2 Other definitions

(1) In this Standard –

inner package, in relation to a food for special medical purposes, means an individual package of the food that –

  (a) is contained and sold within another package that is labelled in accordance with Subdivision 2 of Division 4; and
  (b) is not designed for individual sale, other than a sale by a responsible institution to a patient or resident of the responsible institution.

Note: Example:

Note: An example of an inner package is an individual sachet (or sachets) of a powdered food contained within a box that is fully labelled, being a box available for retail sale.

responsible institution means a hospital, hospice, aged care facility, disability facility, prison, boarding school or similar institution that is responsible for the welfare of its patients or residents and provides food to them.

(2) In this Standard, a reference to a package does not include a plate, cup, tray or other food container in or on which food for special medical purposes is served by a responsible institution to a patient or resident of the responsible institution, whether the plate, cup, tray or food container is uncovered, or is covered in whole or in part.