Schedule 2
Standard 1.1.2—Definitions used throughout the Code
[1] Subsection 1.1.2—2(3)
inner package, in relation to a special medical purpose product for infants, means an individual package of the food that is:
(a) contained and sold within another package that is labelled in accordance with Division 4 of Standard 2.9.1; and
(b) not designed for individual sale, other than a sale by a *responsible institution to a patient or resident of the responsible institution.
Example 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.
[2] Subsection 1.1.2—2(3) (definition of medium chain triglycerides)
[2A] Subsection 1.1.2—2(3) (definition of protein substitute)
[3] Subsection 1.1.2—2(3) (paragraph (c) of the definition of warning statement)
Repeal the paragraph, substitute:
(c) subsection 2.9.1—21(1) (warning statements for infant formula product);
[4] Subsection 1.1.2—3(2) (definitions—particular foods)
special medical purpose product for infants means an infant formula product that is:
-
represented as being:
-
specially formulated for the dietary management of infants who have medically determined nutrient requirements (such as limited or impaired capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food); and
-
suitable to constitute either the sole or principal liquid source of nourishment where dietary management cannot medically be achieved without use of the product; and
(iii) for the dietary management of a medically diagnosed disease, disorder or condition of an infant; and
- intended to be used under medical supervision; and
- not suitable for general use.
[5] Subsection 1.1.2—3(2) (definition of follow-on formula)
follow-on formula means an infant formula product that is represented as:
(a) either a breast milk substitute or replacement for infant formula; and
(b) being suitable to constitute the principal liquid source of nourishment in a progressively diversified diet for infants from the age of 6 months.
[6] Subsection 1.1.2—3(2) (definition of infant formula)
infant formula means an infant formula product that is represented as:
(a) a breast milk substitute for infants; and
(b) satisfying by itself the nutritional requirements of infants under the age of 6 months.
[7] Subsection 1.1.2—3(2) (definition of infant formula product)
infant formula product means a product based on milk or other edible food constituents of animal or plant origin which is represented as nutritionally adequate to serve by itself either as the sole or principal liquid source of nourishment for infants, depending on the age of the infant.
[8] Subsection 1.1.2—3(2) (definition of pre-term formula)
[8A] Subsection 1.1.2—8(2) (definition of novel food)
Repeal the subsection, substitute:
(2) Any of the following:
(a) the presence of a food in a food for special medical purposes;
(b) the presence of a food in a special medical purpose product for infants;
(c) the use of a food as a food for special medical purpose;
(d) the use of a food as a special medical purpose product for infants;
does not constitute a history of human consumption in Australia or New Zealand in relation to that food for the purposes of this section
Standard 1.2.3—Information requirements – warning statements, advisory statements and declarations
[9] Paragraph 1.2.3—6(4)(b)
Repeal the paragraph, substitute
(b) a special medical purpose product for infants.
[10] Note 2 to subsection 1.2.3—6(4)
Repeal the note, substitute:
Note 2 Division 4 of Standard 2.9.1 applies to a special medical purpose product for infants and sets out compositional and labelling requirements for such food.
Standard 1.3.1—Food Additives
[11] Subsection 1.3.1—3(2)
After ‘any food’, insert ‘(other than an infant formula product)’
[12] Paragraph 1.3.1—4(6)(k)
Repeal the paragraph, substitute:
(k) rosemary extract is calculated as the sum of carnosic acid and carnosol;
(l) phosphoric acid and phosphates are calculated as phosphorus.
Standard 1.5.1—Novel Foods
[13] Note to subsection 1.5.1—2(2) (Definition of novel food)
Repeal subsection (2) of the definition, substitute:
(2) Any of the following:
(a) the presence of a food in a food for special medical purposes;
(b) the presence of a food in a special medical purpose product for infants;
(c) the use of a food as a food for special medical purpose;
(d) the use of a food as a special medical purpose product for infants;
do not constitute a history of human consumption in Australia or New Zealand in relation to that food for the purposes of this section.
[13A] Section 1.5.1—3
Repeal the section, substitute:
1.5.1—3 Sale of novel foods
(1) Despite paragraphs 1.1.1—10(5)(b) and (6)(f), a food offered for retail sale (other than an infant formula product) may consist of, or have as an ingredient, a *novel food if:
(a) the novel food is listed in the table to section S25—2; and
(b) any conditions of use specified in the corresponding row of that table are complied with.
Note Novel foods are added to the table to section S25—2 by variations to the Code. When added for the first time, the conditions may include some that apply to the novel food only during the first 15 months after gazettal of the variation. Conditions may also deal with matters such as the following:
· the need for preparation or cooking instructions, warning statements or other advice;
· the need to meet specific requirements of composition or purity;
· the class of food within which the food must be sold;
· during the first 15 months after gazettal, the brand under which the food may be sold.
(2) Despite paragraphs 1.1.1—10(5)(b) and (6)(f), an infant formula product for retail sale may consist of, or have as an ingredient or a *component, a novel food only if:
(a) the novel food is listed in the table to section S25—2; and
(b) the presence of that novel food in the infant formula product is expressly permitted by that table; and
(c) any conditions of use specified in the corresponding row of that table are complied with.
Standard 2.9.2—Food for infants
[14] Section 2.9.2—4
Omit ‘section S29—7’ (wherever occurring), substitute ‘section S29—23’.
[15] Section 2.9.2—5
Omit ‘section S29—7’ (wherever occurring), substitute ‘section S29—23’.
[16] Subsection 2.9.2—6(3)
Standard 2.9.3—Formulated meal replacements and formulated supplementary foods
[17] Subparagraph 2.9.3—3(2)(c)(iii)
Standard 2.9.5—Food for special medical purposes
[18] Paragraph 2.9.5—6(1)(b)