Purpose
This Standard provides for the compositional, and labelling requirements for foods intended or represented for use as a substitute for breast milk, herein referred to as ‘infant formula products’. This Standard applies to all infant formula products whether in powder, liquid concentrate or ‘ready to drink’ forms.
This Standard also provides for infant formula products intended for infants with special nutritional requirements.
There are Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of the legally binding Standard.
Standard 1.3.1 contains provisions relating to the food additives permitted in infant formula products. Standard 1.6.1 contains the microbiological limits in relation to infant formula products. Standard 1.3.4 contains specifications for permitted nucleotides and added nutrients. Standard 1.1.1 defines nutritive substances for the purposes of this Code.
See Standard 1.5.1 – Novel Foods for requirements for novel food and novel food ingredients.
Table of Provisions
Division 1 – General Provisions
Subdivision 1 – Interpretation
1 Definitions
2 Interpretation
Subdivision 2 – Calculations
3 Calculation of energy
4 Calculation of protein
5 Calculation of potential renal solute load
Subdivision 3 – General compositional requirements
6 Restrictions and prohibitions
7 Permitted nutritive substances
8 Limit on nucleotide 5’-monophosphates
9 Lactic acid cultures
10 Limit on aluminium
Subdivision 4 – General labelling and packaging requirements
11 Representations of food as infant formula product
12 Prescribed names
13 Requirement for a measuring scoop
14 Required warnings, directions and statements
15 Print and package size
16 Declaration of nutrition information
17 Date marking and storage instructions
18 Statement of protein source
19 Statement on dental fluorosis
20 Prohibited representations
Division 2 – Infant Formula and Follow-on Formula
21 Composition
22 Protein
23 Fat
24 Vitamins, minerals and electrolytes
Division 3 – Infant Formula Products for Special Dietary Use
Subdivision 1 – Infant formula products formulated for premature or low birthweight infants
25 Composition and labelling
26 Additional labelling
Subdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions
27 Composition
28 Required statements for products under this Subdivision
29 Composition of lactose free and low lactose formulas
30 Claims relating to lactose free and low lactose formulas
Subdivision 3 – Infant formula products for specific dietary use based upon protein substitutes
31 Composition
32 Protein
33 Vitamins and minerals
34 Additional permitted triglycerides
Schedule 1 Permitted forms of vitamins and minerals in infant formula products
Guidelines for infant formula products
Clauses
Division 1
Subdivision 1 – Interpretation
1 Definitions
(1) The definitions in clauses 1 and 2 of Standard 1.2.8 apply to this Standard.
(2) In this Code –
infant means a person under the age of 12 months.
infant formula product means a product based on milk or other edible food constituents of animal or plant origin which is nutritionally adequate to serve as the principal liquid source of nourishment for infants.
infant formula means an infant formula product represented as a breast milk substitute for infants and which satisfies the nutritional requirements of infants aged up to four to six months.
follow-on formula means an infant formula product represented as either a breast-milk substitute or replacement for infant formula and which constitutes the principal liquid source of nourishment in a progressively diversified diet for infants aged from six months.
lactose free formula and low lactose formula means infant formula products which satisfy the needs of lactose intolerant infants.
pre-term formula means an infant formula product specifically formulated to satisfy particular needs of infants born prematurely or of low birthweight.
soy-based formula means an infant formula product in which soy protein isolate is the sole source of protein.
medium chain triglyceri
