Food Standards (Proposal P1028 – Infant Formula) Variation

This instrument, the Food Standards (Proposal P1028 - Infant Formula) Variation, amends Standard 2.9.1 of the Australia New Zealand Food Standards Code by repealing sections 2.9.1,2 to 2.9.1,25 and substituting a new Division structure and detailed compositional, labelling and sale restrictions for infant formula, follow-on formula and special medical purpose products for infants (see Schedule: Standard 2.9.1). The variation was made by the Board of Food Standards Australia New Zealand under section 92 of the Food Standards Australia New Zealand Act 1991 and commences on gazettal (clauses 1, 2 and 3). The Gazette date is specified in the instrument note as 13 September 2024.

Mechanically the instrument does the following:

Replaces the text of Standard 2.9.1 by inserting a new Outline and Definitions (2.9.1,2 to 2.9.1,4), a Division 2 of compositional requirements (2.9.1,5 to 2.9.1,13), Division 3 of labelling and packaging rules for infant and follow-on formula (2.9.1,14 to 2.9.1,28), and Division 4 devoted to special medical purpose products for infants with separate compositional, labelling and sale restrictions (2.9.1,30 to 2.9.1,55). The Schedule lists specific sections and cross-references to tables in Chapter S29 for precise nutrient levels (for example sections S29,2, S29,3, S29,4, S29,5, S29,6, S29,7, S29,9, S29,9A and S29,10 are referenced in the new text).
Establishes a transition regime. Clause 4(2) permits a food product to be sold during the transition period if it complies with either the pre-existing Code or the amended Code; the transition period runs for 60 months from the date of commencement (clause 4(2) and (3)(b)). Clause 4(1) provides that section 1.1.1,9 of Standard 1.1.1 does not apply to the variations made by this instrument (clause 4(1)).

Food Standards Australia New Zealand

The Board of Food Standards Australia New Zealand gives notice of the making of this variation under section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the date specified in clause 3 of this variation.

Dated 12 September 2024

Signature C. Leemhuis

Christel Leemhuis, General Manager Risk Assessment and Science Branch

Delegate of the Board of Food Standards Australia New Zealand

Note:

This variation will be published in the Commonwealth of Australia Gazette No. FSC 171 on 13 September 2024. This means that this date is the gazettal date for the purposes of clause 3 of the variation.

1 Name

This instrument is the Food Standards (Proposal P1028 – Infant Formula) Variation.

2 Variation to a standard in the Australia New Zealand Food Standards Code

The Schedule varies a Standard in the Australia New Zealand Food Standards Code.

3 Commencement

The instrument commences on gazettal.

4 Effect of the variations made by this instrument

Note New Zealand has under Annex D of the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System opted out of Standard 2.9.1.

(1) Section 1.1.1—9 of Standard 1.1.1 does not apply to the variations made by this instrument.

(2) During the transition period, a food product may be sold if the product complies with one of the following:

(a) the Code as in force without the variations made by the instruments; or

(b) the Code as amended by the variations made by the instruments.

(3) For the purposes of this clause:

(a) the instruments means:

(i) this instrument; and

(ii) the Food Standards (Proposal P1028 – Infant Formula – Consequential Amendments) Variation;

(b) the transition period means the period commencing on this instrument’s date of commencement and ending 60 months after the date of commencement.

Schedule

Standard 2.9.1

[1] Sections 2.9.1—2 to 2.9.1—25

Repeal the sections, substitute:

2.9.1—2 Outline of Standard

(1) This Standard regulates various types of infant formula products.

(2) Division 1 deals with preliminary matters.

(3) Division 2 sets out compositional requirements for infant formula and follow-on formula.

(4) Division 3 sets out labelling and packaging requirements for infant formula and follow-on formula.

(5) Division 4 sets out compositional, labelling and restriction on sale requirements for a special medical purpose product for infants.

2.9.1—3 Definitions

Note In this Code (see sections 1.1.2—2 and 1.1.2—3):

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.

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.

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.

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.

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.

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.

2.9.1—4 Interpretation

Interpretation of compositional requirements

(1) Unless otherwise expressly stated, compositional requirements in this Standard apply to:

(a) a powdered or concentrated form of infant formula product that has been reconstituted with water according to directions; and

(b) an infant formula product in ‘ready to drink’ form.

Calculation of energy, protein and vitamin A

(2) In this Standard:

(a) energy must be calculated in accordance with section S29—2; and

(b) protein content must be calculated in accordance with section S29—2A; and

Division 2 Compositional requirements for infant formula and follow ‑on formula

Note Subsection 1.5.1—3(2) provides that an infant formula product for retail sale may consist of, or have as an ingredient or a component, a novel food only if each condition specified in that subsection is met.

2.9.1—5 General requirements

(1) Infant formula and follow-on formula must have an energy content of no less than 2510 kJ/L and no more than 2930 kJ/L.

(2) Subject to subsections (3) and (4), infant formula and follow-on formula must not contain added fructose and/or added sucrose.

(3) Infant formula and follow-on formula manufactured from partially hydrolysed protein may contain added fructose and/or added sucrose, provided that:

(a) the fructose and/or sucrose is added to the formula to provide a source of carbohydrate; and

(b) the sum of the fructose and/or sucrose in the formula does not exceed 20% of available carbohydrates in the formula.

(4) Subsection (2) does not apply to added fructose and/or added sucrose that is present in infant formula and follow-on formula as a result of:

(a) the addition of inulin-type fructans to the infant formula or follow-on formula in accordance with this Standard; and/or

(b) the use of a substance as a processing aid in accordance with this Code in the manufacture of the infant formula or follow-on formula.

(5) The fluoride content of infant formula and follow-on formula must not exceed:

(a) if in a powdered or concentrated form—17 μg/100 kJ; and

(b) if in a ‘ready-to-drink’ form—24 μg/100 kJ.

(6) The amounts in subsection (5) apply to the infant formula or follow-on formula as sold.

2.9.1—6 Protein requirements

(1) Infant formula and follow-on formula must be derived only from one or more of the following proteins:

(a) cow milk;

(b) goat milk;

(d) soy protein isolate;

(e) a partially hydrolysed protein of one or more of the above.

(2) Infant formula must have a protein content of:

(a) for milk-based infant formula—no less than 0.43 g/100 kJ and no more than 0.72 g/100 kJ; and

(b) for infant formula that is not milk-based infant formula—no less than 0.54 g/100 kJ and no more than 0.72 g/100 kJ.

(3) Follow-on formula must have a protein content of:

(a) for milk-based follow-on formula—no less than 0.38 g/100 kJ and no more than 0.72 g/100 kJ; and

(b) for follow-on formula that is not milk-based follow-on formula—no less than 0.54 g/100 kJ and no more than 0.72 g/100 kJ.

(4) For the purposes of subsections (2) and (3):

(a) milk-based infant formula means infant formula that is derived only from 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; and

(b) milk-based follow-on formula means follow-on formula that is derived only from 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.

(5) The L-amino acids listed in the table to section S29—3 must be present in infant formula and follow-on formula at a level not less than the corresponding minimum level specified in the table.

(6) 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 infant formula and follow-on formula is not less than 15 mg per 100 kJ; and

(b) the ratio of methionine to cysteine in the infant formula and follow-on formula is less than 2 to1.

(7) 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 infant formula and follow-on formula is not less than 37 mg per 100 kJ; and

(b) the ratio of tyrosine to phenylalanine in the infant formula and follow-on formula is less than 2 to 1.

(8) Despite subsections (5), (6) and (7), L-amino acids listed in the table to section S29—3 must only be added to infant formula or follow-on formula in an amount necessary to improve protein quality.

2.9.1—7 Fat requirements

(1) Infant formula and follow-on formula 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

(i) 90 mg/100 kJ of linoleic acid; and

(ii) 12 mg/100 kJ of α-linolenic acid; and

Note. It is recommended that infant formula and follow-on formula 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 infant formulas and follow-on formula 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—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 formula—contain not more than the maximum amount (if any) specified in Column 2 of the table for that fatty acid.

(2) Infant formula and follow-on formula may only contain medium chain triglycerides that:

(a) contain predominantly the saturated fatty acids designated by 8 to 0 and 10 to 0; and

(b) are one of the following:

(i) a natural constituent of a milk-based ingredient of that formula; or

(ii) for a fat soluble vitamin that is specified in a following table—a substance that was *used as a processing aid in the preparation of that permitted fat soluble vitamin for use in the formula:

(A) for infant formula—the table to section S29—5; and

(B) for follow-on formula—the table to section S29—6.

(3) Infant formula and follow-on formula must not have a phospholipid content of more than 72 mg/100 kJ.

2.9.1—8 Required nutritive substances

(1) Infant formula must contain each substance listed in Column 1 of the table to section S29—5 in an amount (including any naturally-occurring amount) that is:

(a) no less than the minimum amount specified in Column 2 of the table; and

(b) no more than the maximum amount (if any) specified in Column 3 of the table.

Note It is recommended that infant formula contain a substance listed in Column 1 of the table to section S29—5 in an amount that is not more than the amount (if any) specified for that substance in Column 4 of that table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose 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. These Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of infant formulas or due to technological reasons.

(2) Follow-on formula must contain each substance listed in Column 1 of the table to section S29—6 in an amount (including any naturally-occurring amount) that is:

(a) no less than the minimum amount specified in Column 2 of the table; and

(b) no more than the maximum amount (if any) specified in Column 3 of the table.

Note It is recommended that follow-on formula contain a substance listed in Column 1 of the table to section S29—6 in an amount that is not more than the amount (if any) specified for that substance in Column 4 of that table. The amounts specified in Column 4 are Guidance Upper Levels, which are recommended upper levels for nutrients which pose 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. The Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of follow-on formulas or due to technological reasons.

(3) The ratio of calcium to phosphorus in infant formula and follow-on formula must be no less than 1 to 1 and no more than 2 to 1.

2.9.1—9 Optional nutritive substances

(1) A substance listed in Column 1 of the table to section S29—7 may be *used as a nutritive substance in infant formula, provided that the amount of the substance in the formula (including any naturally-occurring amount) is:

(a) no less than the minimum amount (if any) specified in Column 2 of the table; and

(b) no more than the maximum amount (if any) specified in Column 3 of the table.

(2) A substance listed in Column 1 of the table to section S29—8 may be *used as a nutritive substance in follow-on formula, provided that is the amount of the substance in the formula (including any naturally-occurring amount) is:

(a) no less than the minimum amount (if any) specified in Column 2 of the table; and

(b) no more than the maximum amount (if any) specified in Column 3 of the table.

Note It is recommended that follow-on formula contain a substance listed in Column 1 of the table to section S29—8 in an amount that is not more than the amount (if any) specified for that substance in Column 4 of that table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose 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. These Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of follow-on formulas or due to technological reasons.

2.9.1—10 Required forms for nutritive substances

A substance used in infant formula or follow-on formula in accordance with section 2.9.1—8 or 2.9.1—9 must be added in a permitted form listed in:

(a) if a vitamin, mineral or electrolyte—the table to section S29—23; and

(b) in any other case— the table to section S29—9.

2.9.1—10A Infant formula products—conditions on use of permitted nutritive substances

(1) This section applies to a substance that is:

(a) used as a nutritive substance in an infant formula product; and

(b) listed in Column 1 of the table to section S29—9A; and

(2) The substance must comply with the conditions (if any) specified in Column 3 of the table to section S29—9A for that substance in that permitted form.

2.9.1—11 Addition of lactic acid producing microorganisms

L(+) lactic acid producing microorganisms may be added to infant formula and follow-on formula.

2.9.1—12 Restriction on addition of inulin-type fructans and galacto‑oligosaccharides

If an *inulin-type fructan or a *galacto-oligosaccharide is added to infant formula or follow-on formula, the product must contain (taking into account both the naturally‑occurring and added substances) no more than:

(a) if only inulin-type fructans are added—110 mg/100 kJ of inulin-type fructans; or

(b) if only galacto-oligosaccharides are added—290 mg/100 kJ of galacto‑oligosaccharides; or

(i) no more than 110 mg/100 kJ of inulin-type fructans; and

(ii) no more than 290 mg/100 kJ of combined inulin-type fructans and galacto-oligosaccharides.

2.9.1—13 Restriction on levels of other substances

Infant formula and follow-on formula must not contain any of the following:

(a) detectable gluten; or

(b) more than 3.8 mg/100 kJ of free nucleotide-5′-monophosphates.

Note 1 Section S19—4 contains the maximum levels (ML) of contaminants in infant formula products.

Note 2 Standard 1.3.1 and Schedule 15 permit the use of certain substances as food additives in infant formula products.

Division 3 Labelling and packaging requirements for infant formula and follow-on formula

Note Standard 1.2.7 provides that a nutrition content claim or *health claim must not be made about infant formula products. See paragraph 1.2.7—4(b). Paragraph 1.2.7—6(a) provides that this prohibition does not apply to claims that are expressly permitted by the Code, including by this Division.

2.9.1—14 Representations about food as infant formula or follow-on formula

A food may only be represented as infant formula or follow-on formula if the food complies with this Standard.

2.9.1—15 Product differentiation

The label on a package of infant formula or follow-on formula must differentiate that infant formula or follow-on formula from other foods by the use of text, pictures and/or colour.

Example The text, pictures and/or colours used on a label of infant formula must differentiate that product from, among other things, follow-on formula, a special medical purpose product for infants, or a formulated supplementary food for young children.

2.9.1—16 Prescribed names

(1) ‘Infant formula’ is the *prescribed name for infant formula.

(2) ‘Follow-on formula’ is the *prescribed name for follow-on formula.

Note Under the labelling provisions in Standard 1.2.1 and section 1.2.2—2, if a food has a prescribed name, that prescribed name must be used in the labelling of the food.

2.9.1—17 Requirement for measuring scoop

(1) A package of infant formula or follow-on formula in a powdered form must contain a scoop to enable the use of the formula in accordance with the directions contained in the label on the package.

(2) Subsection (1) does not apply to single serve sachets, or packages containing single serve sachets, of formula in a powdered form.

2.9.1—18 Storage instructions

For the labelling provisions, the storage instructions for infant formula and follow-on formula must cover the period after the package is opened.

Note The labelling provisions are set out in Standard 1.2.1.

2.9.1—19 Requirement for the name of the food

For the labelling provisions, the name of the food must be stated on the front of a package of infant formula or follow-on formula.

Note The labelling provisions are set out in Standard 1.2.1.

2.9.1—20 Statement of protein source

(1) For the labelling provisions, the specific animal or plant source or sources of protein in infant formula and follow-on formula must be included in the statement of the name of the food required by section 2.9.1—19.

Examples ‘Infant formula based on cow milk’. ‘Follow-on formula based on goat milk. ‘Infant formula based on soy protein’.

Note 1 Section 2.9.1—6(1) lists the permitted sources of protein for infant formula and follow-on formula.

Note 2 The labelling provisions are set out in Standard 1.2.1.

(2) If infant formula and follow-on formula are derived solely or in part from a partially hydrolysed protein, the words 'partially hydrolysed' must be used immediately adjacent to the protein source required by subsection (1).

Example ‘Infant formula based on partially hydrolysed cow milk’.

(3) The statement of protein source required by subsection (1) must not use the word ‘milk’ as the sole descriptor of the protein source.

Example ‘Infant formula based on milk’ or ‘Infant formula sourced from milk’ is not permitted.

Note See subparagraph 2.9.1—28(1)(j)(i) in relation to the use of the word ‘milk’ on the label separately and in addition to in a statement of protein source.

2.9.1—21 Requirement for warning statements and directions

Warning statements

(1) For the labelling provisions, the following *warning statements are required for infant formula and follow-on formula:

(a) ‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Incorrect preparation can make your baby very ill.’; and

(b) a heading that states ‘Important Notice’ (or words to that effect), with under it the *warning statement—‘Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice.’.

Note The labelling provisions are set out in Standard 1.2.1.

Required statements on use

(2) For the labelling provisions, the required statements for infant formula and follow‑on formula are ones indicating that:

(a) for infant formula—the infant formula may be used from birth; and

(b) for follow-on formula—the follow-on formula should not be used for infants aged under the age of 6 months; and

(c) for infant formula and follow-on formula—it is recommended that infants from the age of 6 months should be offered foods in addition to the infant formula or follow-on formula.

Note The labelling provisions are set out in Standard 1.2.1.

Location of required statements

(3) The statements required by paragraphs (2)(a) and (b) must appear on the front of the package of the product.

(4) Subsection (3) does not prevent a statement required by subsection (2) from appearing more than once on the label.

Directions on preparation and use

(5) For the labelling provisions, directions on preparation and use are required for infant formula and follow-on formula which instruct (in words and pictures) that:

(a) each bottle must be prepared individually; and

(b) if a bottle of prepared formula is to be stored prior to use, it must be refrigerated and used within 24 hours; and

(d) if a package contains a measuring scoop—only the enclosed scoop must be used; and

(e) for powdered or concentrated formula—do not change proportions of the powder or concentrate or add other food except on medical advice; and

(f) for ready-to-drink formula—do not dilute or add other food except on medical advice; and

(g) formula left in the bottle after a feed must be discarded within 2 hours.

Note The labelling provisions are set out in Standard 1.2.1.

(6) Paragraphs (5)(a), (b) and (c) do not apply to ready-to-drink formula.

(7) Paragraph (5)(d) does not apply to concentrated formula and ready-to drink formula.

(8) For the labelling provisions, the following must be declared for infant formula and follow-on formula:

(a) for a product in powdered or concentrated form—the proportion of powder or concentrate required to reconstitute the formula according to directions; and

(b) for a product in powdered form—the weight of one scoop.

Note The labelling provisions are set out in Standard 1.2.1.

2.9.1—22 Print size

The warning statements required by subsection 2.9.1—21(1) must be in a *size of type of at least:

(a) if the package of infant formula or follow-on formula has a net weight of more than 500 g—3 mm;

(b) if the package of infant formula or follow-on formula has a net weight of 500 g or less—1.5 mm.

2.9.1—23 Optional format for the statement of ingredients – added vitamins and minerals

(1) Despite section 1.2.4—5, where a vitamin or mineral is added to infant formula or follow-on formula in accordance with section 2.9.1—8, the statement of ingredients need not list the added vitamin and mineral in descending order of ingoing weight, provided that the statement of ingredients:

(a) lists all added vitamins together under the subheading ‘Vitamins’; and

(b) lists all added minerals together under the subheading ‘Minerals’.

Note See Standard 1.2.4 for other ingredient labelling requirements.

(2) Section 1.2.4—8 does not apply to a statement of ingredients referred to in subsection (1).

2.9.1—24 Declaration of nutrition information

(1) For the labelling provisions, a statement of nutrition information is required for infant formula and follow-on formula.

(2) A reference in this section to ‘the statement’ is the statement required by subsection (1).

(3) The statement must contain the following information:

(a) the *average energy content expressed in kilojoules per 100 mL of formula; and

(b) the *average quantity of protein, fat and *carbohydrate expressed in grams per 100 mL of formula and as ‘protein’, ‘fat’ and ‘carbohydrate’, respectively; and

(c) the *average quantity of each vitamin or mineral expressed in micrograms or milligrams per 100 mL of formula (including any naturally‑occurring amount); and

(d) for infant formula—the *average quantity of choline, inositol and L-carnitine expressed in milligrams per 100 mL of formula (including any naturally-occurring amount); and

(e) if added, the *average quantity of the following, expressed in grams, micrograms or milligrams per 100 mL of formula:

(i) any substance *used as a nutritive substance (including any naturally‑occurring amount); or

(ii) *inulin-type fructans; or

(iii) *galacto-oligosaccharides; or

(iv) a combination of inulin-type fructans and galacto-oligosaccharides.

Note The labelling provisions are set out in Standard 1.2.1.

(4) The statement may include the *average quantity of each of the following substances that is present in the infant formula or follow-on formula, expressed in grams per 100 mL of formula (including any naturally‑occurring amount):

(a) whey; and

(b) casein.

(5) The statement may include the *average quantity of each of the following substances that is present in the infant formula or follow-on formula, expressed in milligrams per 100 mL of formula (including any naturally‑occurring amount):

(a) docosahexaenoic acid; and

(b) eicosapentaenoic acid; and

(6) If the infant formula or follow-on formula is in a powdered or concentrated form, information included in the statement in accordance with subsection (3), (4) or (5) must be expressed in terms of per 100 mL of formula as reconstituted according to the directions on the package.

(7) In addition to being expressed in accordance with subsection (6), information included in the statement in accordance with subsection (3), (4) or (5) may also be expressed:

(a) if sold in a concentrated form —per 100 mL of the formula as sold; or

(b) if sold in a powdered form —per 100 g of formula as sold.

(8) Unless expressly provided elsewhere in this Code, the statement must not contain any other information.

2.9.1—25 Required form for the declaration of nutrition information

(1) A reference to ‘the table’ in this section is a reference to the table to section S29—10.

(2) Subject to this section, the statement required by section 2.9.1—24 must:

(a) be in the same format as specified in the table; and

(b) state the nutrition information in the order specified in the table; and

(d) have the following subheadings printed in a size of type that is the same or larger than the nutrient names in the statement:

(i) for infant formula and follow-on formula—‘Vitamins’, ‘Minerals’ and ‘Additional’; and

(ii) for infant formula only—‘Other nutrients’; and

(e) state nutrients and subgroup nutrients using the names and units of measurement specified in the table for that nutrient and subgroup; and

(f) not express an amount or quantity other than in accordance with section 2.9.1—24.

(3) If the statement includes the *average quantity of a permitted nutritive substance, an *inulin-type fructan or a *galacto-oligosaccharide, that average quantity must be included in the statement:

(a) under the subheading ‘Additional’; and

(b) in the same format as specified in the table for that substance.

(4) If the statement includes the *average quantity of choline, inositol or L-carnitine, that average quantity must be included in the statement:

(a) for infant formula—under the subheading ‘Other nutrients’; and

(b) for follow-on formula—under the subheading ‘Additional’; and

(5) If the statement includes the *average quantity of a substance listed in subsection 2.9.1—24(4), that average quantity must be included in the statement in the same format as specified in the table for that substance.

(6) If the statement includes the *average quantity of the substances listed in subsection 2.9.1—24(5), the statement:

(a) must include the subheading ‘Long chain polyunsaturated fatty acids’ that is printed in a size of type that is the same or larger than the nutrient names in the statement; and

(b) must include that average quantity:

(i) under the subheading ‘Long chain polyunsaturated fatty acids’; and

(ii) in the same format as specified in the table for those substances; and

(d) may use the acronym specified in the table for the following substances in addition to the name required for those substances by paragraph (c):

(i) docosahexaenoic acid; and

(ii) eicosapentaenoic acid; and

(iii) arachidonic acid.

Example The statement may use ‘Docosahexaenoic acid (DHA)’ or ‘Docosahexaenoic acid’, but not ‘DHA’.

(7) If the statement includes information expressed in accordance with subsection 2.9.1—24(7), that information must be in an additional column at the right hand side of the column shown in the table.

(8) Information included in the additional column required by subsection (7) must be in the form required by this section.

Note For an example nutrition information statement including information expressed in accordance with subsection 2.9.1—24(7), see section S29—10A.

2.9.1—26 How average quantity is to be calculated

Despite section 1.1.1—6, the method in paragraph 1.1.1—6(3)(c) must not be used to calculate the *average quantity of a substance in infant formula or follow‑on formula.

2.9.1—27 Requirements for use of stage numbers

(1) The following numbers may be used on the label on a package of infant formula or follow-on formula to identify for consumers that the product is infant formula or follow‑on formula:

(a) if the product is infant formula—the number ‘1’; and

(b) if the product is follow-on formula—the number ‘2’.

(2) A number used in accordance with subsection (1) must appear:

(a) on the front of the package of the product; and

(b) immediately adjacent to:

(i) for infant formula—the statement required by paragraph 2.9.1—21(2)(a); and

(ii) for follow-on formula—the statement required by paragraph 2.9.1—21(2)(b).

(3) Subsection (2) does not prevent a number used in accordance with subsection (1) from also appearing elsewhere on the label.

2.9.1—28 Prohibited representations

(1) The label on a package of infant formula or follow-on formula must not contain:

(a) a picture of an infant; or

(b) a picture that idealises the use of infant formula or follow-on formula; or

(i) for infant formula—follow-on formula, a special medical purpose product for infants, a formulated supplementary food or a formulated supplementary food for young children; or

(ii) for follow-on formula—infant formula, a special medical purpose product for infants,a formulated supplementary food or a formulated supplementary food for young children.

(d) the word ‘humanised’ or ‘maternalised’ or any word or words having the same or similar effect; or

(e) the words ‘human milk oligosaccharide’, ‘human identical milk oligosaccharide’ or any word or words having the same or similar effect; or

(f) the abbreviations ‘HMO’ or HiMO’ or any abbreviation having the same or similar effect; or

(g) words claiming that the formula is suitable for all infants; or

(h) information relating to the nutritional content of human milk; or

(i) information relating to the presence of a substance listed in subsection (2), except for a reference in:

(i) a statement of ingredients; or

(ii) a declaration or statement expressly permitted or required by this Code; or

(j) information relating to ingredients, except for:

(i) use of the word ‘milk’; or

(ii) a reference in a statement of ingredients; or

(iii) a reference in a declaration or statement expressly permitted or required by this Code; or

(k) information relating to the animal or plant source or sources of protein except:

(i) in a statement of ingredients; or

(ii) where required by subsection 2.9.1—20(1); or

(l) the words ‘partially hydrolysed’ or any word or words having the same or similar effect, except:

(i) in a statement of ingredients; or

(ii) where required by subsection 2.9.1—20(2).

(2) For the purposes of paragraph (1)(i), the following substances are listed:

(a) an *inulin-type fructan; and

(b) a *galacto-oligosaccharide; and

(d) a substance *used as a nutritive substance’.

Note Section 2.9.1—24 expressly requires or permits these substances to be declared or stated in the nutrition information statement required by that section.

Division 4 Special medical purpose product for infants

2.9.1—30 Application of other Standards

Unless the contrary intention appears, the following provisions do not apply to a special medical purpose product for infants:

(a) Part 1.2 of Chapter 1 (labelling and other information requirements); and

(b) Division 3 of this Standard.

2.9.1—31 Restriction on the sale of special medical purpose products for infants

(1) A special medical purpose product for infants must not be sold to a consumer, other than from or by:

(a) a medical practitioner or dietitian; or

(b) a medical practice, pharmacy or *responsible institution; or

(2) In this section:

majority seller means, in relation to a special medical purpose product for infants, a person who:

(a) during any 24 month period, sold that special medical purpose product for infants to any of the following:

(i) a medical practitioner;

(ii) a dietitian;

(iii) a medical practice;

(iv) a pharmacy;

(v) a *responsible institution; and

(b) the sales mentioned in paragraph (a) represent more than one half of the total amount of that special medical purpose product for infants sold by the person during that 24 month period.

medical practitioner means a person registered or licensed as a medical practitioner under legislation in Australia or New Zealand, as the case requires, for the registration or licensing of medical practitioners.

2.9.1—32 General compositional requirements

(1) A special medical purpose product for infants must have an energy content of no less than 2510 kJ/L and no more than 2930 kJ/L.

(2) Subject to subsections (3) and (4), a special medical purpose product for infants must not contain added fructose and/or added sucrose.

(3) A special medical purpose product for infants manufactured from partially hydrolysed protein may contain added fructose and/or added sucrose, provided that:

(a) the fructose and/or sucrose is added to the product to provide a source of carbohydrate; and

(b) the sum of the fructose and/or sucrose in the product does not exceed 20% of available carbohydrates in the product.

(4) Subsection (2) does not apply to added fructose and/or added sucrose that is present in a special medical purpose product for infants as a result of:

(a) the addition of *inulin-type fructans to the product in accordance with this Standard; and/or

(b) the use of a substance as a processing aid in accordance with this Code in the manufacture of the product.

(5) The fluoride content of a special medical purpose product for infants must not exceed:

(a) if in a powdered or concentrated form—17 μg/100 kJ; and

(b) if in a ‘ready-to-drink’ form—24 μg/100 kJ.

(6) The amounts in subsection (5) apply to the special medical purpose product for infants as sold.

2.9.1—33 Protein requirements

(1) A special medical purpose product for infants must be only derived from one or more of the following proteins:

(a) cow milk;

(b) goat milk;

(d) soy protein isolate;

(e) a partially hydrolysed protein of one or more of the above.

(2) A special medical purpose product for infants must have a protein content of:

(a) for a milk-based product—no less than 0.43 g/100 kJ and no more than 0.72 g/100 kJ; and

(b) for a product that is not milk-based product—no less than 0.54 g/100 kJ and no more than 0.72 g/100 kJ.

(3) For the purposes of subsection (2), milk-based product means a special medical purpose product for infants that is derived only from 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

(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 for infants for retail sale may have, as an ingredient or a *component, a novel food, provided that the presence of that novel food in the product is necessary to achieve that product’s intended medical purpose.

2.9.1—36 Required nutritive substances

(1) A special medical purpose product for infants must contain each substance listed in Column 1 of the table to section S29—5 in an amount (including any naturally-occurring amount) that is:

(a) no less than the minimum amount specified in Column 2 of the table; and

(b) no more than the maximum amount (if any) specified in Column 3 of the table.

Note It is recommended that a special medical purpose product for infants contain a substance listed in Column 1 of the table to section S29—5 in an amount that is not more than the amount (if any) specified for that substance in Column 4 of that table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose 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. These Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of a special medical purpose product for infants or due to technological reasons.

(2) The ratio of calcium to phosphorus in a special medical purpose product for infants must be no less than 1 to 1 and no more than 2 to 1.

2.9.1—37 Optional nutritive substances

A substance listed in Column 1 of the table to section S29—7 may be *used as a nutritive substance in a special medical purpose product for infants, provided that the amount of the substance in the product (including any naturally-occurring amount) is:

(a) no less than the minimum amount (if any) specified in Column 2 of the table; and

(b) no more than the maximum amount specified in Column 3 of the table.

2.9.1—38 Required forms for nutritive substances

A substance used in a special medical purpose product for infants in accordance with section 2.9.1—36 or 2.9.1—37 must be in a permitted form listed in:

(a) if a vitamin, mineral or electrolyte—the table to section S29—23; and

(b) in any other case— the table to section S29—9.

2.9.1—39 Addition of lactic acid producing microorganisms

L(+) lactic acid producing microorganisms may be added to a special medical purpose product for infants.

2.9.1—40 Restriction on addition of inulin-type fructans and galacto‑oligosaccharides

If an *inulin-type fructan or a *galacto-oligosaccharide is added to a special medical purpose product for infants, the product must contain (taking into account both the naturally‑occurring and added substances) no more than:

(a) if only inulin-type fructans are added—110 mg/100 kJ of inulin-type fructans; or

(b) if only galacto-oligosaccharides are added—290 mg/100 kJ of galacto-oligosaccharides; or

(i) no more than 110 mg/100 kJ of inulin-type fructans; and

(ii) no more than 290 mg/100 kJ of combined inulin-type fructans and galacto-oligosaccharides.

2.9.1—41 Restriction on levels of other substances

A special medical purpose product for infants must not contain any of the following:

(a) detectable gluten; or

(b) more than 3.8 mg/100 kJ of free nucleotide-5′-monophosphates.

Note 1 Section S19—4 contains the maximum levels (ML) of contaminants in infant formula products.

Note 2 Standard 1.3.1 and Schedule 15 permit the use of certain substances as food additives in infant formula products including a special medical purpose product for infants.

2.9.1—42 Permitted variation from compositional requirements

(1) A special medical purpose product for infants need not comply with a compositional requirement to the extent that a variation from that requirement:

(a) is necessary to achieve the product’s intended medical purpose; or

(b) would otherwise prevent the sale of the product.

(2) For the purposes of subsection (1), a compositional requirement means a requirement imposed in relation to a special medical purpose product for infants by any of the following:

(a) any of sections 2.9.1—32 to 2.9.1—41, but not section 2.9.1—35;

(b) paragraph 1.1.1—10(6)(a);

(d) paragraph 1.1.1—10(6)(c).

2.9.1—43 Representations about food as a special medical purpose product for infants

A food may only be represented as a special medical purpose product for infants if it complies with this Division.

2.9.1—44 Product differentiation

The label on a package of a special medical purpose product for infants must differentiate that product from other foods by the use of text, pictures and/or colour.

Example The text, pictures and/or colours used on a label of a special medical purpose product for infants must differentiate that product from, among other things, infant formula, follow-on formula or a formulated supplementary food for young children.

2.9.1—45 Prohibited representations

The label on a package of a special medical purpose product for infants must not contain:

(a) a picture of an infant; or

a picture or text that idealises the use of special medical purpose product for infants; or

(c) the words ‘human milk oligosaccharide’, ‘human identical milk oligosaccharide’ or any word or words having the same or similar effect; or

(d) the abbreviations ‘HMO’ or HiMO’ or any abbreviation having the same or similar effect.

2.9.1—46 Prohibited claims

(1) A claim in relation to a special medical purpose product for infants must not:

(a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition; or

(b) compare the product with a good that is:

(i) represented in any way to be for therapeutic use; or
(ii) likely to be taken to be for therapeutic use, whether because of the way in which the good is presented or for any other reason.

(2) A nutrition content claim or *health claim must not be made about a special medical purpose product for infants.

(3) This section does not apply to:

(a) a claim that is expressly permitted by this Code; or

(b) a declaration that is required by an application Act.

2.9.1—47 Permitted lactose free claim

A claim that a special medical purpose product for infants is lactose free may be made if that special medical purpose product for infants contains no detectable lactose.

2.9.1—48 Labelling and related requirements

(1) This section applies to a food for sale that is a special medical purpose product for infants.

(2) If the food for sale is in a package, it is required to *bear a label that complies with section 2.9.1—49.

(3) If the food for sale is in an *inner package:

(a) the inner package is required to *bear a label that complies with section 2.9.1—54; and

(b) there is no labelling requirement under this Code for any other packaging associated with the food for sale.

(4) If the food for sale is in a *transportation outer:

(a) the transportation outer or package containing the food for sale is required to *bear a label that complies with section 2.9.1—55; and

(b) there is no labelling requirement under this Code for any other packaging associated with the food for sale.

2.9.1—49 Mandatory labelling information

(1) The label that is required for a special medical purpose product for infants must state the following information in accordance with the provision indicated:

(a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2);

(b) lot identification (see section 1.2.2—3);

(i) information relating to *foods produced using gene technology (see section 1.5.2—4); and

(ii) information relating to irradiated food (see section 1.5.3—9);

(d) any mandatory statements and declarations (see section 2.9.1—50);

(e) information relating to ingredients (see section 2.9.1—51);

(f) date marking information (see section 2.9.1—52);

(g) directions for the preparation, use or storage of the product, if the product is of such a nature to require such directions for health or safety reasons;

(h) nutrition information (see section 2.9.1—53).

(2) The label that is required for a special medical purpose product for infants must comply with section 1.2.1—24 of Standard 1.2.1.

2.9.1—50 Mandatory statements and declarations— special medical purpose product for infants

For paragraph 2.9.1—49(1)(d), the following statements are required:

(a) a statement to the effect that the product must be used under medical supervision;

(b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the product;

(c) a statement indicating the medical purpose of the product, which may include a disease, disorder or medical condition for which the product has been formulated;

(d) a statement describing the properties or characteristics which make the product appropriate for the medical purpose indicated in paragraph (c);

(e) if the product has been formulated for a specific age group—a statement to the effect that the product is intended for persons within the specified age group;

(f) a statement indicating whether or not the product is suitable for use as a sole source of nutrition;

(g) if the product is represented as being suitable for use as a sole source of nutrition:

(i) a statement to the effect that the product is not for parenteral use; and

(ii) if the product has been modified to vary from the compositional requirement of this Division such that the content of one or more nutrients falls short of the prescribed minimum, or exceeds the prescribed maximum (if applicable):

(A) unless provided in other documentation about the product—a statement indicating the nutrient or nutrients which have been modified; and

(B) unless provided in other documentation about the product—a statement indicating whether each modified nutrient has been increased, decreased, or eliminated from the product, as appropriate; and

(h) the declarations required by section 1.2.3—4.

2.9.1—51 Information relating to ingredients—special medical purpose product for infants

For paragraph 2.9.1—49(1)(e), the information relating to ingredients is:

(a) a statement of ingredients; or

(b) information that complies with Articles 18, 19 and 20 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers; or

2.9.1—52 Date marking information—special medical purpose product for infants

(1) For paragraph 2.9.1—49(1)(f), the required date marking information is date marking information in accordance with Standard 1.2.5.

(2) Despite subsection (1), for subparagraph 1.2.5—5(2)(a)(ii), the words ‘Expiry Date’, or similar words, may be used on the label.

2.9.1—53 Nutrition information—special medical purpose product for infants

(1) For paragraph 2.9.1—49(1)(h), the nutrition information required for a special medical purpose product for infants is the following, expressed per given amount of the product:

(a) the minimum or *average energy content; and

(b) the minimum amount or *average quantity of:

(i) protein, fat and carbohydrate; and

(ii) any vitamin, mineral or electrolyte that has been *used as a nutritive substance in the product; and

(i) *used as a nutritive substance in that product; and

(ii) added to that product to achieve that product’s intended medical purpose; and

(d) any of the following information if declaration of that information is necessary for use of the special medical purpose product for infants for its intended medical purpose:

(i) information on sub-group nutrients of protein, fat and/or carbohydrate;

(ii) osmolality and osmolarity;

(iii) acid-base balance.

(2) A reference in subsection (1) to the intended medical purpose is to the intended medical purpose as described in the statement required by paragraph 2.9.1—50(c).

(3) The label that is required for a special medical purpose product for infants may state information relating to the source or sources of protein in that product.

2.9.1—54 Labelling requirements—special medical purpose product for infants in inner package

(1) The label on an *inner package that contains a special medical purpose product for infants must state the following information in accordance with the provision indicated:

(a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2);

(b) lot identification (see section 1.2.2—3);

(d) date marking information (see section 2.9.1—52).

(2) The label must comply with section 1.2.1—24 of Standard 1.2.1.

(3) To avoid doubt, this section continues to apply to the label on the *inner package if a *responsible institution subsequently supplies the inner package to a patient or resident of the responsible institution.

2.9.1—55 Labelling requirements—special medical purpose product for infants in transportation outer

(1) If packages of a special medical purpose product for infants are contained in a transportation outer, the information specified in subsection (2) must, in accordance with the provisions indicated, be:

(a) contained in a label on the transportation outer; or

(b) contained in a label on a package of the food for sale, and clearly discernible through the transportation outer.

(2) For subsection (1), the information is:

(a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2); and

(b) lot identification (see section 1.2.2—3); and

1 Food Standards (Proposal P1028 – Infant Formula) Variation

Food Standards (Proposal P1028 – Infant Formula) Variation

Dated 12 September 2024

Christel Leemhuis, General Manager Risk Assessment and Science Branch

Delegate of the Board of Food Standards Australia New Zealand

Note:

1 Name

This instrument is the Food Standards (Proposal P1028 – Infant Formula) Variation.

2 Variation to a standard in the Australia New Zealand Food Standards Code

The Schedule varies a Standard in the Australia New Zealand Food Standards Code.

3 Commencement

The instrument commences on gazettal.

4 Effect of the variations made by this instrument

Note New Zealand has under Annex D of the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System opted out of Standard 2.9.1.

(1) Section 1.1.1—9 of Standard 1.1.1 does not apply to the variations made by this instrument.

(2) During the transition period, a food product may be sold if the product complies with one of the following:

(a) the Code as in force without the variations made by the instruments; or

(b) the Code as amended by the variations made by the instruments.

(3) For the purposes of this clause:

(a) the instruments means:

(i) this instrument; and

(ii) the Food Standards (Proposal P1028 – Infant Formula – Consequential Amendments) Variation;

(b) the transition period means the period commencing on this instrument’s date of commencement and ending 60 months after the date of commencement.

Schedule

Standard 2.9.1

[1] Sections 2.9.1—2 to 2.9.1—25

Repeal the sections, substitute:

2.9.1—2 Outline of Standard

(1) This Standard regulates various types of infant formula products.

The instrument organises the updated Standard 2.9.1 around four main conceptual pillars: definitions and scope; compositional controls; labelling and packaging controls; and a distinct track for special medical purpose products for infants. Those pillars are reflected in the new Outline (2.9.1,2) and the Division headings.

Definitions and scope. The instrument tightens and clarifies terms that determine regulatory coverage. Key defined terms include infant formula, follow-on formula, infant formula product, special medical purpose product for infants, inner package and responsible institution (2.9.1,3). The definitions are functional and claim-based: e.g. infant formula is defined by representation as a breast milk substitute and by its intended ability to satisfy nutritional requirements of infants under 6 months (2.9.1,3). Follow-on formula is characterised as a product represented either as a breast milk substitute or replacement and suitable as the principal liquid source of nourishment in a progressively diversified diet from 6 months (2.9.1,3). The definitions therefore couple compositional and marketing representations; representation is an element of regulatory classification (see also 2.9.1,14 which requires compliance with the Standard before a food can be represented as infant formula or follow-on formula).

Compositional controls. Division 2 sets mandatory nutrient ranges and ingredient limitations. Energy density must fall between 2510 kJ/L and 2930 kJ/L for infant and follow-on formula and for special medical purpose products (2.9.1,5(1); 2.9.1,32(1)). Protein sources are limited to cow, goat, sheep milk, soy protein isolate or partially hydrolysed forms of those proteins (2.9.1,6(1); 2.9.1,33(1)). Protein content ranges are specified by type and product class: milk-based infant formula 0.43-0.72 g/100 kJ; non-milk-based infant formula 0.54-0.72 g/100 kJ; follow-on formula has slightly different minima for milk-based formulations (2.9.1,6(2)-(3)). Fat content is likewise tightly constrained (1.1-1.4 g/100 kJ) and fatty acid profile, linoleic/alpha-linolenic ratios and minimum linoleic/α-linolenic amounts are prescribed (2.9.1,7(1)). Specific substances are constrained or prohibited, for example no detectable gluten, fluoride maximums expressed per 100 kJ and limits on free nucleotide-5′-monophosphates (2.9.1,5(5)-(6); 2.9.1,13; 2.9.1,41).

Labelling and packaging controls. Division 3 places detailed obligations on labelling including required front-of-pack statements, prescribed names, differentiation from other foods by text/picture/colour, mandatory warning statements and preparation directions, scoop inclusion for powdered products, minimum print sizes for warnings, nutrition information table format and order, and prohibited representations such as pictures of infants or statements that idealise formula use (2.9.1,14 to 2.9.1,28). Nutrition information must state average energy in kJ/100 mL, macronutrient averages per 100 mL, and average quantities of each vitamin or mineral per 100 mL (2.9.1,24).

Special medical purpose products. Division 4 separates special medical purpose products for infants from standard infant and follow-on formula in several ways. First, Part 1.2 labelling and Division 3 of the Standard do not apply to them unless stated (2.9.1,30). Second, the text imposes a restriction on sale channels: SMP products must not be sold to consumers except from or by medical practitioners, dietitians, medical practices, pharmacies, responsible institutions, or a majority seller as defined (2.9.1,31(1)). Third, compositional regimes mirror those for standard formula but include a specific permitted variation clause allowing compositional departures to the extent necessary to achieve the product’s intended medical purpose or to avoid preventing sale (2.9.1,42). Fourth, labelling for SMP products is specialised, with mandatory declarations about medical supervision, medical purpose, precautions, and, where applicable, the nutritional modifications arising from compositional deviations (2.9.1,49 to 2.9.1,53).

Cross-references and calculation methods. The variation embeds multiple cross-references to other Code provisions and tables in Chapter S29 for precise nutrient minima and maxima (for example S29,3 for L-amino acids and S29,5/S29,6 for required nutritive substances) and prescribes calculation approaches for energy, protein and vitamin A in terms of S29,2, S29,2A and S29,2B (2.9.1,4(2)). It also disallows a particular averaging method in paragraph 1.1.1,6(3)(c) when calculating average quantities for infant formula products (2.9.1,26).

Regulatory texture. The instrument differentiates mandatory limits from Guidance Upper Levels. Several notes label certain maxima as recommended Guidance Upper Levels (for example linoleic acid recommendation at 335 mg/100 kJ in 2.9.1,7 note, and recommended upper levels for nutrients in 2.9.1,8 and related notes). The instrument therefore mixes binding minima and maxima with non-binding recommended upper levels.

International and transitional context. The instrument records New Zealand’s opt-out from Standard 2.9.1 under Annex D of the ANZ joint food standards agreement (clause 4 note) and creates a 60 month transition period during which products may comply with either the pre-amendment Code or the amended Code (clause 4(2)).

Collectively these concepts create a closed regulatory specification for composition and packaging for infant formula, follow-on formula and special medical purpose products, with a separate commercial channel control for the latter class and a long transition window for industry compliance.

The text creates obligations that fall primarily on manufacturers and label designers, importers and distributors, retailers and specified health sector suppliers, and institutions that procure and use special medical purpose products for infants. Each stakeholder group is affected in different ways by compositional limits, labelling rules and sale restrictions.

Manufacturers and formulators. Producers of infant formula, follow-on formula and special medical purpose products must ensure their products meet detailed compositional ranges and ingredient restrictions. Mandatory energy, protein and fat ranges are specified (2.9.1,5(1); 2.9.1,6(2)-(3); 2.9.1,7(1)), and protein sources are limited to a closed list (cow, goat, sheep milk, soy protein isolate, or partially hydrolysed variants) (2.9.1,6(1)). Manufacturers who use inulin-type fructans, galacto-oligosaccharides, lactic acid producing microorganisms or novel foods must stay within the caps or conditions set out (for example caps on inulin-type fructans and galacto-oligosaccharides in 2.9.1,12 and 2.9.1,40; permitted addition of L(+) lactic acid producing microorganisms at 2.9.1,11 and 2.9.1,39). The instrument also requires that nutritive substances be in permitted forms listed in S29,9 or S29,23 (2.9.1,10, 2.9.1,38). Manufacturers will bear the direct compliance costs of reformulation, analytical testing and ingredient sourcing to meet these thresholds.

Label designers and packaging firms. The label rules are prescriptive. Required front-of-pack statements (such as “Warning - follow instructions exactly” and “Important Notice… Breast milk is best for babies”) must appear and certain statements must be on the front of pack (2.9.1,21(1)-(4)). A measuring scoop must be included in powdered products except single serve sachets (2.9.1,17). Nutrition information must be presented in a specified table format and order with precise nutrient names and subheadings (2.9.1,24, 2.9.1,25). The label must avoid prohibited representations such as pictures of infants or words like ‘humanised’ (2.9.1,28(1)(a), (d)). Designers will need to restructure packaging art, text hierarchy and print sizes (2.9.1,22).

Importers, distributors and retailers. Retailers selling special medical purpose products for infants are constrained in who may sell to consumers. SMP products may not be sold to a consumer except from or by a medical practitioner or dietitian, a medical practice, a pharmacy, a responsible institution, or a majority seller as defined (2.9.1,31(1)). The majority seller is narrowly defined by sales over a 24 month period to specific medical channels (2.9.1,31(2)). That restricts general grocery or online retailing of such products to the extent they are characterised as SMP. For infant formula and follow-on formula sold at retail, standard labelling obligations apply and non-compliant items cannot be represented as infant formula (2.9.1,14; 2.9.1,19).

Healthcare providers and responsible institutions. Hospitals, pharmacies, hospices, aged care facilities, disability facilities, prisons, boarding schools or similar institutions are defined as responsible institutions (2.9.1,3). These bodies interact with inner package labelling rules for SMP products: inner packages not designed for individual sale have specific labelling rules where sold by a responsible institution to a patient or resident (2.9.1,3 definition; 2.9.1,54(3)). Responsible institutions that supply inner packages to patients still must comply with inner package labelling (2.9.1,54(3)).

Consumers. End consumers are affected through the information they receive and the availability of products. Front-of-pack warnings and preparation directions target consumer safety (2.9.1,21(1), (5)). The prohibition on certain representations and claims restricts the information manufacturers may use to promote products (2.9.1,28). For special medical purpose products, consumer access is restricted to specified channels which can affect purchasing pathways and potentially price and availability (2.9.1,31).

Regulatory actors. Food Standards Australia New Zealand (the Board) is the decision maker as the instrument is made under s 92 of the FSANZ Act 1991 (clauses 1, 2). The instrument also cross-references multiple other Code provisions and tables that are consulted or used for nutrient calculation and permitted ingredient lists, so officials administering the Code will be the interpreter and enforcer at the compliance stage (see for example references to S29,2, S29,3, S29,5 and Standard 1.2.1).

Geographic distinction. The instrument explicitly notes that New Zealand has opted out of Standard 2.9.1 under Annex D of the ANZ Joint Food Standards System (clause 4 note). This means the variation applies to Australia but not to New Zealand, which affects suppliers operating across both jurisdictions.

Suppliers of novel foods and speciality ingredients. The instrument places constraints on the use of novel foods in infant formula products for retail sale, referring manufacturers back to subsection 1.5.1,3(2) for conditions (Division 2 note). For special medical purpose products an exception is provided where a novel food is necessary to achieve the medical purpose (2.9.1,35). Suppliers of novel ingredients therefore face different pathways depending on whether the product is retail infant formula or a SMP product.

Overall, the principal financial burden will fall on manufacturers and brand owners who must ensure compositional compliance, undertake testing and redesign labels. Retailers and distributors will face operational effects from the sale channel restriction for SMP products and from product differentiation and packaging changes. Consumers may experience changes in product presentation and choice, and potential availability differences for SMP products due to distribution restrictions. All of these effects are traceable to the sections cited above.

This instrument imposes mandatory duties on manufacturers, labelers, suppliers and sellers, and creates a limited set of entitlements or permissions for the use of specific ingredients and packaging practices. The duties are expressed as prescriptive compositional limits, explicit labelling, and sale-channel restrictions.

Duties: compositional requirements and ingredient limits

Energy density. All infant formula, follow-on formula and special medical purpose products for infants must meet energy content between 2510 kJ/L and 2930 kJ/L (2.9.1,5(1); 2.9.1,32(1)). This is a mandatory range.
Carbohydrate sources. Infant and follow-on formula must not contain added fructose or sucrose, except in narrowly defined circumstances for partially hydrolysed proteins and processing aids, and subject to caps (2.9.1,5(2)-(4)). Special medical purpose products are subject to the same constraints (2.9.1,32(2)-(4)).
Fluoride. Fluoride content limits for powdered/concentrated and ready-to-drink forms are set per 100 kJ as sold (2.9.1,5(5)-(6); 2.9.1,32(5)-(6)).
Protein sources and levels. Only specified proteins are permitted as sources (cow, goat, sheep milk, soy protein isolate, partially hydrolysed forms); protein content minima and maxima depend on whether the formula is milk-based or not and whether it is infant or follow-on formula (2.9.1,6(1)-(4); 2.9.1,33(1)-(3)). L-amino acid minimums in table S29,3 must be met, subject to specified ratio exceptions (2.9.1,6(5)-(7); 2.9.1,33(4)-(6)).
Fat composition. Fat content and fatty acid profiles are regulated including linoleic:α-linolenic ratio, minimum absolute linoleic and α-linolenic amounts, vitamin E minimum per gram of PUFAs, and constraints on certain long chain polyunsaturated fatty acids (2.9.1,7(1)(a)-(g); 2.9.1,34(1)). Phospholipid content caps are included (2.9.1,7(3); 2.9.1,34(3)).
Specific prohibitions. Detectable gluten is prohibited and free nucleotide-5′-monophosphates are capped at 3.8 mg/100 kJ (2.9.1,13; 2.9.1,41).
Prebiotic fibres and probiotics. Limits on inulin-type fructans and galacto-oligosaccharides are prescribed for infant, follow-on and SMP products (2.9.1,12; 2.9.1,40). L(+) lactic acid producing microorganisms may be added (2.9.1,11; 2.9.1,39).

Duties: labelling, packaging and information

Prescribed names and representation. ‘Infant formula’ and ‘Follow-on formula’ are the prescribed names and if a product is represented as such it must comply with the Standard (2.9.1,14, 2.9.1,16).
Differentiation and front of pack. Labels must differentiate product from other foods by text, pictures and/or colour (2.9.1,15). The name of the food must be on the front of package (2.9.1,19).
Required warnings and statements. Labels must contain specified warning statements about preparation, an “Important Notice” that includes the phrase “Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice,” plus specific required statements on use for infant and follow-on formula (2.9.1,21(1)-(4)).
Preparation and storage directions. Comprehensive directions must be provided, including instructions that each bottle be prepared individually, storage limits if prepared, use of previously boiled and cooled potable water, and discarding instructions for feed leftovers (2.9.1,21(5)-(7)). For powdered products, the proportion to reconstitute and weight of one scoop must be declared (2.9.1,21(8)).
Scoop requirement. A measuring scoop must be included in powdered packages except single serve sachets (2.9.1,17).
Print size. Required minimum font sizes for warning statements depend on net weight (2.9.1,22).
Nutrition declaration format. Nutrition information must follow the format, order and nutrient naming conventions in the table to S29,10 and conform to specified subheadings (2.9.1,24; 2.9.1,25). The method in paragraph 1.1.1,6(3)(c) must not be used to calculate average quantities for infant formula or follow-on formula (2.9.1,26).

Duties: special medical purpose product sale and labelling

Sale restrictions. A special medical purpose product for infants must not be sold to a consumer except via specified channels, including medical practitioners, dietitians, medical practices, pharmacies, responsible institutions, or a majority seller (2.9.1,31(1)). The majority seller definition specifies a sales-share test over a 24 month period to defined purchasers (2.9.1,31(2)).
Mandatory SMP labelling. SMP products must bear labelling that includes statements that they must be used under medical supervision, the medical purpose and properties that make the product appropriate, precautions and contraindications, and if formulated for a specific age group that age group, among other mandatory declarations (2.9.1,49 to 2.9.1,50).
Permitted compositional variation. SMP products may deviate from compositional requirements when necessary to achieve the intended medical purpose or to prevent the product being unsaleable, subject to the section’s scope (2.9.1,42).

Permissions, exceptions and limited rights

Certain additions allowed. The Standard permits addition of L(+) lactic acid producing microorganisms (2.9.1,11, 2.9.1,39).
Permitted optional nutritive substances. Certain substances listed in S29,7 and S29,8 are optional if used within the minima and maxima set in those tables (2.9.1,9).
Novel foods. For retail sale, an infant formula product may include a novel food only if each condition in subsection 1.5.1,3(2) is met (Division 2 note). For SMP products a novel food may be used if necessary to achieve the intended medical purpose (2.9.1,35).
Optional ingredient listing format. Where vitamins and minerals are added per section 2.9.1,8, the statement of ingredients may group vitamins and minerals under subheadings rather than list in descending ingoing weight, subject to 2.9.1,23(1)-(2).
Lactose free claim for SMP. A lactose free claim is permitted for SMP products only if no detectable lactose is present (2.9.1,47).

Limited prohibitions and claim restrictions

The Standard prohibits images of infants, idealising imagery, certain ingredient references and claim words such as ‘humanised’, ‘maternalised’, and certain oligosaccharide descriptors on infant and follow-on formula labels (2.9.1,28(1)(a)-(f), (1)(j)-(l)) and similarly restricts SMP labels (2.9.1,45). This constrains commercial speech on labels.
Nutrition content claims and health claims are generally prohibited for infant formula products under Standard 1.2.7, with only express Code permissions exempted (Division 3 note). For SMP products nutrition content or health claims are prohibited (2.9.1,46(2)) except where expressly permitted by the Code or required by application Acts (2.9.1,46(3)).

Nature of compliance obligation

Representation rule. A food may only be represented as infant formula, follow-on formula or SMP if it complies with the corresponding parts of this Standard (2.9.1,14; 2.9.1,43). This makes both composition and representation jointly necessary to qualify.
Transition relief. During the 60 month transition period, sellers may market products that comply either with the Code as in force before the variation or with the amended Code (clause 4(2)). The instrument also disapplies section 1.1.1,9 to the variations (clause 4(1)), which is a technical application choice.

The instrument therefore creates a duty-heavy regime that combines precise compositional tolerances with prescriptive labelling and sale-channel restrictions, while allowing limited permissions for certain ingredients, optional labelling formats and medical-purpose exceptions. Rights are primarily narrow and instrument-specific: permission to use particular optional substances if within listed bounds, the ability to sell SMP products via defined health channels, and an explicit pathway for novel foods in SMPs where necessary for medical purpose.

The variation text itself does not set out penalties or detailed enforcement mechanisms. The instrument is a variation to the Australia New Zealand Food Standards Code made under section 92 of the Food Standards Australia New Zealand Act 1991 (clauses 1-3); it prescribes compositional, labelling and sale restrictions in Standard 2.9.1 but does not include express sanctioning provisions within the substituted sections. Two consequences follow directly from the instrument as drafted.

Absence of penalty clauses in the substituted Standard. The new or amended sections set mandatory compositional and labelling requirements (for example 2.9.1,5 to 2.9.1,13 for composition, and 2.9.1,21 to 2.9.1,25 for labelling) but do not themselves prescribe monetary penalties, seizure powers or criminal offences. The instrument does not authorise or replicate enforcement actions such as infringement notices, fines or other sanctions within the Standard text that is reproduced.
Non-compliance as representation failure. The Standard makes compliance with its provisions a condition of representation. For example, section 2.9.1,14 states a food may only be represented as infant formula or follow-on formula if the food complies with this Standard. Similarly, section 2.9.1,43 requires that a food may only be represented as a special medical purpose product for infants if it complies with Division 4. The practical legal effect is that misrepresentation or incorrect labelling will result in the product failing to meet the Code’s representation rules.

Enforcement architecture implied by cross-references. While the variation does not itself create new enforcement powers, it sits inside the existing Code and FSANZ institutional framework. The instrument cross-references other Standards and sections of the Code that set out labelling, ingredients and permitted forms (for example Standard 1.2.1 on labelling and information provisions, Standard 1.2.4 on ingredient listings, S29 tables for nutrient levels). Enforcement of those provisions is typically undertaken under the food regulatory enforcement regimes of the relevant application Acts of the Australian States and Territories, and under New Zealand law where the Code has been adopted. The instrument does not state this enforcement pathway; it therefore remains implicit in the Code architecture and in the fact the Board made the variation under the FSANZ Act (clauses 1-3).

Practical enforcement implications that derive from the text

Compliance will be a condition of lawful representation. Because the Standard ties representation to compliance (2.9.1,14; 2.9.1,43), enforcement actions could be brought where a product is represented as infant formula or follow-on formula but fails to meet compositional, labelling or nutritional information requirements.
Sale restrictions create regulatory compliance checks. The prohibition on consumer sale of SMP products except via specified channels (2.9.1,31(1)) creates a bright-line compliance obligation for sellers and supply chain actors which, if breached, leads to the product not being offered lawfully as an SMP under the Code.
Labelling format and nutrient declaration obligations facilitate inspection and laboratory verification. The mandatory nutrition information format and required nutrient declarations (2.9.1,24; 2.9.1,25) provide an auditable basis for enforcement testing and determination.

No penalties are named in the instrument. A reader should note that the Code as a statutory instrument operates within a broader enforcement regime under application Acts of jurisdictions where it is in force, and that this variation creates compliance obligations which, if unmet, will likely be prosecuted or otherwise enforced under those application Acts rather than under a penalty schedule in the Standard itself. The variation’s repeated cross-references to other Code provisions and to tables in Chapter S29 mean that enforcement will in practice involve both label inspection and laboratory analysis against the nutrient minima, maxima and permitted forms cited in the Standard.

In short, the instrument prescribes mandatory duties and representation rules, but leaves the specification of civil or criminal penalties to the broader legal framework that gives the Code effect in each jurisdiction. The instrument itself does not alter that enforcement architecture in terms of novel penalties or enforcement mechanisms.

The variation integrates tightly with other parts of the Australia New Zealand Food Standards Code. It both relies on existing definitions and calculation methods in the Code and excludes or modifies the application of certain procedural Code provisions to this instrument. Several cross-references and interface points are explicit in the text; each affects how the Standard operates within the overall legal framework.

Direct cross-references to other Code provisions and Schedules

Calculation methods and nutrient tables. The Standard requires that energy be calculated in accordance with section S29,2, protein by S29,2A and vitamin A by S29,2B (2.9.1,4(2)(a)-(c)). It requires L-amino acids to meet minimums specified in the table to S29,3 (2.9.1,6(5)); it refers to the tables to S29,4, S29,5, S29,6, S29,7, S29,9, S29,9A and S29,10 for permitted forms, nutrient minima and maxima, and nutrition information table formatting (for example 2.9.1,7(1)(g); 2.9.1,8; 2.9.1,10; 2.9.1,25). These references mean that the precise numeric obligations rest in the S29 tables and that changes to those tables would immediately affect compliance under 2.9.1.
Labelling and claims regimes. Division 3 repeatedly references Standard 1.2.1 labelling provisions and Standard 1.2.4 ingredient labelling rules (see notes and specific cross-references such as 2.9.1,21 note, 2.9.1,23(1) and 2.9.1,25(1)(e)). Section 2.9.1,28 cites Standard 1.2.7 prohibitions on nutrition content and health claims as context and cross-checks. That means the labelling rules in 2.9.1 are intended to be read together with the general labelling provisions and claim restrictions elsewhere in the Code.
Novel foods. The instrument signals that an infant formula product for retail sale may include a novel food only if each condition in subsection 1.5.1,3(2) is met (Division 2 note). For special medical purpose products an explicit exception allows novel foods if necessary to achieve the intended medical purpose (2.9.1,35). This divides the pathway for novel ingredients between retail infant formula products and SMP products. Therefore, the regulatory treatment of novel foods under section 1.5.1 and any approvals, safety assessments or conditions in that section will apply to infant formula products that propose to use novel foods.
Provisions displaced or disapplied. Clause 4(1) states that section 1.1.1,9 of Standard 1.1.1 does not apply to the variations made by this instrument. The instrument does not reproduce 1.1.1,9 so the direct effect must be read from clause 4(1). Additionally, Division 4 states that “Unless the contrary intention appears, the following provisions do not apply to a special medical purpose product for infants: (a) Part 1.2 of Chapter 1 (labelling and other information requirements); and (b) Division 3 of this Standard” (2.9.1,30). That creates a bespoke labelling regime for SMPs which displaces general labelling obligations in Part 1.2 and Division 3 of this Standard.

Inter-jurisdictional effect and New Zealand opt-out

New Zealand exclusion. The instrument includes an explicit note that New Zealand has opted out of Standard 2.9.1 under Annex D of the Agreement between Australia and New Zealand concerning a joint food standards system (clause 4 note). This creates a legal divergence: the amended Standard applies in Australia, whereas New Zealand does not adopt these variations. For manufacturers and importers operating across both markets, this requires managing different product specifications and labelling for each jurisdiction.

Transition interactions

Transition period. Clause 4(2) establishes a transition period of 60 months during which products may comply with either the Code as in force without the variations or the Code as amended by the variations. The instruments referred to in clause 4(3)(a) include this instrument and the consequential amendments instrument. Therefore, the amended Standard does not immediately displace prior label and composition regimes for products already in commerce for a 60 month window, which interacts with supply chain inventory, import timing and existing packaging stocks.

Compatibility with other regulatory instruments

Reference to application Acts and external labelling regimes. Several parts of Division 4 require compliance with other labelling schemes or foreign regulations as acceptable alternatives for ingredient information on SMP product labels , specifically Articles 18-20 of EU Regulation 1169/2011 or 21 CFR § 101.4 as alternatives to a statement of ingredients (2.9.1,51). This creates a cross-border regulatory recognition for content presentation on SMP labels and allows use of certain well-known formats in place of the standard Australian ingredient declaration.

Impacts on claims and marketing law

Claims limitations in the Standard interact with Standard 1.2.7. The Division 3 note points to Standard 1.2.7 which prohibits nutrition content and health claims for infant formula products, except where expressly permitted by the Code (Division 3 note; see also 2.9.1,46 for SMPs). That linkage means advertising and promotional activities for these products must comply with the Code-wide claim rules, and any conflict would be resolved by reading these provisions together.

Operational enforcement and testing

Calculation method exclusion. The variation disallows the method in paragraph 1.1.1,6(3)(c) for calculating average quantity of a substance in infant formula or follow-on formula (2.9.1,26). This specific methodological interaction modifies how lab analysis and averaging over lots may be carried out relative to general methods elsewhere in the Code, with downstream effects on test protocols and compliance assessments.

In sum, the variation is tightly interwoven with existing Code provisions and external instruments. Compliance requires reading the new Standard alongside S29 tables, Part 1.2 labelling rules (except for SMP exceptions), Standard 1.5.1 on novel foods, and calculation methods. The New Zealand opt-out and the 60 month transition window create temporal and jurisdictional exceptions that businesses must plan for in multi-jurisdiction supply chains.

This instrument itself is an amendment to Standard 2.9.1 effected by the Food Standards (Proposal P1028 - Infant Formula) Variation. The amendment history contained in the instrument is limited but precise, providing the dates of enactment, commencement, and an explicit transitional arrangement.

Key amendment steps and dates

Making and date. The Board of Food Standards Australia New Zealand made the variation and dated it on 12 September 2024; the instrument states it will be published in the Commonwealth of Australia Gazette No. FSC 171 on 13 September 2024, which is the gazettal date for the purposes of clause 3 (instrument notes; clause 3). Clause 3 states the instrument commences on gazettal.
Repeal and substitution. The Schedule to the instrument expressly repeals sections 2.9.1,2 to 2.9.1,25 and substitutes new content in their place. The substituted material creates a reorganised Standard with new section numbering and substantive content across Division 1 to Division 4 (Schedule heading and first line “[1] Sections 2.9.1,2 to 2.9.1,25 Repeal the sections, substitute:”).
Transition period. Clause 4 establishes transitional arrangements: section 1.1.1,9 of Standard 1.1.1 does not apply to the variations made by this instrument (clause 4(1)). Clause 4(2) sets a transition period in which food products may be sold if they comply either with the Code as in force without the variations or the Code as amended by the variations. Clause 4(3)(b) defines the transition period as commencing on the instrument’s date of commencement and ending 60 months after that date.
Related instruments. Clause 4(3)(a)(ii) identifies a related instrument, the Food Standards (Proposal P1028 - Infant Formula - Consequential Amendments) Variation, as part of the instruments to which the transition period applies. The transition regime therefore contemplates consequential amendments implemented alongside this variation.

Replacement structure and content

Replaced material. The repealed sections gave way to an expanded Standard including a clearer Outline (2.9.1,2), a Definitions section (2.9.1,3), compositional sections (2.9.1,5 to 2.9.1,13), labelling and packaging (2.9.1,14 to 2.9.1,28), and a full Division 4 for special medical purpose products for infants (2.9.1,30 onwards).
New cross-references. The substituted text introduces multiple references to S29 tables and to other Standards (Standard 1.2.1, 1.2.4, 1.2.5, 1.3.1 and 1.5.1,3(2)), embedding the new Standard in a network of Code provisions.

Noted external decisions

New Zealand opt-out. The instrument contains an explicit note that New Zealand has opted out of Standard 2.9.1 under Annex D of the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System (clause 4 note). That note is recorded as part of the instrument’s amendment history and indicates a jurisdictional divergence at the time of making.

What the instrument does not include in amendment history

The instrument text does not reproduce earlier amendment history of Standard 2.9.1 prior to the repeal; it only records the repeal and substitution as of this variation. It does not enumerate prior versions, previous amendment dates, or a full amendment log history in this instrument. For a comprehensive chronological record, users must consult the consolidated Code or FSANZ historical records.

Operational consequence of the 60 month transition

Dual compliance window. The 60 month period is significant. Manufacturers, importers and retailers are given five years to adjust packaging, formulations and distribution arrangements. During that period, products compliant with either the old or new Code may be sold (clause 4(2)). This creates a prolonged phase-in which reduces immediate supply-chain disruption but increases the period during which two regulatory regimes coexist.

Consequential amendments

The instrument explicitly links to a consequential amendments variation (clause 4(3)(a)(ii)). Those consequential changes are treated as part of the instruments for the transition regime. The variation does not reproduce the text of those consequential amendments; to understand the full amendment set, one must read both instruments together.

Administrative provenance

Made under FSANZ Act. The instrument is made under section 92 of the Food Standards Australia New Zealand Act 1991 (instrument header). The Board’s delegate, identified in the instrument, signed on behalf of the Board (instrument signature block).

In sum, the amendment history captured in the instrument is limited to the date of making, the repeal and substitution of specified sections, the commencement on gazettal, the 60 month transition window including the link to consequential amendments, and the New Zealand opt-out. The instrument leaves prior historical alterations to Standard 2.9.1 and subsequent consequential instruments to be consulted elsewhere.

The variation text does not itself record any litigation history. The instrument is a formal statutory variation to the Code and contains no references to judicial decisions, tribunal rulings or dispute outcomes. Therefore there are no cases, appeals or enforcement litigation mentioned within the text.

Potential areas where litigation or disputes could arise, grounded in the instrument

While the instrument contains no litigation history, the text identifies several provisions where ambiguity, interpretation disputes or enforcement challenges are reasonably foreseeable. The following points describe those potential dispute loci and the textual bases for them.

“Representation” as a determinative test (2.9.1,3; 2.9.1,14; 2.9.1,43). The definitions of infant formula, follow-on formula and special medical purpose product for infants hinge on how a product is “represented” and whether it is “suitable” for particular nutritional roles (2.9.1,3). Disputes may arise about whether marketing, packaging or ingredient composition amounts to a representation that triggers the Standard. Litigation could focus on the borderline between product descriptions, implied claims and the conditions set out for each product class.
Interpretation of “suitable to constitute the principal liquid source of nourishment” or “satisfying by itself the nutritional requirements” (2.9.1,3). Those phrases are functional and potentially fact-sensitive. Determining whether a product is suitable as the principal liquid source for a given age cohort might require expert evidence and could lead to contested determinations under consumer protection or regulatory enforcement actions.
Definition and assessment of “majority seller” (2.9.1,31(2)). The majority seller test depends on sales over any 24 month period to a narrow set of buyers and whether those sales represent more than one half of the total product sold by the person during that 24 month period. Disputes about the correct accounting period, whether certain sales count, or interpretation of “sold to” and “total amount sold” could arise.
SMP compositional variation necessity test (2.9.1,42). The permitted variation from compositional requirements for special medical purpose products is allowed where necessary to achieve the product’s intended medical purpose or to avoid preventing sale. Litigation could involve contesting whether a particular compositional deviation is indeed necessary to achieve the medical purpose, a question likely to involve medical and scientific evidence.
Nutrient calculation methodology (2.9.1,4(2); 2.9.1,26). The Standard adjusts calculation references to S29 tables and disallows a specific averaging method in paragraph 1.1.1,6(3)(c) for calculating average quantity. Disputes may arise about appropriate laboratory testing methods, sampling frames and statistical methods to determine compliance with average nutrient declarations, particularly when results are near minimax thresholds.
Prohibited representations and claim boundaries (2.9.1,28; 2.9.1,46). The restrictions on words such as ‘humanised’ and on the use of “human milk oligosaccharide” and abbreviations like HMO create potential controversies about whether new descriptive terms have “the same or similar effect”. Determinations about whether particular label language is impermissible could give rise to enforcement actions and appeals.
Interaction with Standard 1.5.1 on novel foods (Division 2 note; 2.9.1,35). Where manufacturers seek to introduce a novel food or ingredient, disputes can arise over whether the conditions of subsection 1.5.1,3(2) are met or whether the SMP exception for necessary novel foods applies. That could trigger procedural disputes over approvals, data sufficiency and risk assessments.
Cross-jurisdictional product differences because of New Zealand opt-out (clause 4 note). Companies operating in both Australia and New Zealand may face conflicts about which product versions are lawful where trade between jurisdictions occurs. While not a litigation issue per se in the instrument, enforcement actions in one jurisdiction may be the source of ancillary disputes in cross-border commerce.

Absence of recorded litigation does not mean absence of enforcement risk. The instrument’s tight compositional and labelling prescriptions, combined with the representation-linked classification tests, create a legal regime in which fact-specific determinations and expert evidence are likely to determine contested outcomes. Disputes would be resolved in the usual venues for food regulatory disputes under the relevant application Acts, administrative review processes, or courts, but the instrument does not itself record any such proceedings.

The instrument contains many detailed requirements, cross-references and negative rules that can easily be overlooked. The following points identify specific traps for manufacturers, label designers, suppliers and distributors that arise directly from the text.

Representation is a threshold for classification. The definitions link classification to how a product is represented (2.9.1,3). If a product is presented in marketing, labelling or packaging so as to be a breast milk substitute or replacement, it is treated as infant formula or follow-on formula and must comply. Small changes in label wording or marketing could change a product’s regulatory status.
Transition period allows dual compliance for 60 months, but after that date only the new Standard applies. During the 60 month window a product may be sold if it complies with either the pre-variation Code or the amended Code (clause 4(2)). Firms must track the expiry of this dual-compliance window; relying on old packaging or formulations beyond the 60 months will not be lawful.
NZ opt-out. New Zealand’s opt-out means companies must maintain jurisdiction-specific formulations and labels for Australia and New Zealand if exporting to both markets (clause 4 note). Failure to segregate inventory or to apply correct labels can create compliance exposure.
Scoop inclusion and single-serve exception. A measuring scoop must be included in powdered or concentrated forms unless the product is a single serve sachet or a package containing single serve sachets (2.9.1,17). Companies selling multi-serve sachets or bundled sachets should check whether the exception applies and ensure scoops are included where required. A missing scoop is an independent label/packaging compliance fault.
Strict front-of-pack placement requirements. Several statements must appear on the front of the package, including the name of the food and required statements for age suitability (2.9.1,19; 2.9.1,21(3)). Minor layout choices that place required statements elsewhere may render labels non-compliant.
Wording prohibitions are wide and include “same or similar effect”. The list of prohibited words and phrases is not exhaustive; the Standard bans wording “having the same or similar effect” for terms like ‘humanised’ and certain oligosaccharide descriptors (2.9.1,28(1)(d)-(f)). This means marketers must be cautious about synonyms and novel wording that could be interpreted as carrying the prohibited effect.
Ingredient disclosure restrictions. The Standard prohibits information relating to ingredients on the front of pack, except limited uses (2.9.1,28(1)(j)-(k)). At the same time the statement of protein source must be included in the name of the food on the front of pack (2.9.1,20). The instrument also forbids using the word ‘milk’ alone as the sole protein descriptor (2.9.1,20(3)). These rules constrain front-of-pack branding and require careful drafting to comply with both disclosure and prohibition requirements.
Conflicting labelling regimes for SMP products. Division 4 disapplies Part 1.2 of Chapter 1 and Division 3 of this Standard for SMP products unless the contrary intention appears (2.9.1,30). Instead SMPs have their own mandatory labelling requirements (2.9.1,49 to 2.9.1,53). Suppliers must not assume general labelling approaches will satisfy SMP-specific requirements.
Sale restrictions are sales-channel specific and fact-intensive. The prohibition on consumer sales for SMP products applies except where sold by specified actors including a “majority seller” defined by precise sales metrics over 24 months (2.9.1,31). Firms that supply both retail and institutional channels should audit their customer mixes against the majority seller test.
Novel food pathways differ between retail infant formula and SMP products. For a retail infant formula product to include a novel food, it must meet the conditions of subsection 1.5.1,3(2) (Division 2 note). For SMP products, novel foods are allowed if necessary to achieve the medical purpose (2.9.1,35). Companies relying on a novel ingredient should ensure they are on the right legal path and have appropriate approvals or justifications documented.
Calculation method caveat. The Standard disallows the averaging method in paragraph 1.1.1,6(3)(c) for infant and follow-on formula average quantity calculations (2.9.1,26). Analysts and laboratories must confirm the correct averaging method and sample plan; using the wrong method may produce a false compliance reading.
Nutrition information restrictions. The declaration must only contain the listed items and “must not contain any other information” unless expressly provided elsewhere in the Code (2.9.1,24(8)). Additional marketing-oriented nutrition statements on the nutrition panel may therefore be non-compliant.
Guidance Upper Levels are not mandatory maxima. Notes to several sections identify Guidance Upper Levels as recommendations rather than binding maxima (for example 2.9.1,7 note and 2.9.1,8 note). Firms must not misread “recommended” levels as permissive limits; where the Standard sets a mandatory maximum, that must be met. Where only Guidance Upper Levels are stated, higher levels may still require justification and could attract scrutiny.
Prohibition on some claims for SMP products. Nutrition content claims and health claims are prohibited for SMP products and other prohibitions detailed in 2.9.1,46 apply. Marketing teams should avoid terms that could be interpreted as therapeutic claims.
Inner package and transportation outer labelling. For SMP products sold in inner packages or contained in transportation outers additional labelling requirements apply (2.9.1,48 to 2.9.1,55). Responsible institutions that repurpose or resupply inner packages must ensure compliance persists post-supply (2.9.1,54(3)).

Each of these items follows from specific sections of the instrument. Compliance programmes should map each requirement against product lines, packaging variants and sales channels to avoid inadvertent breaches.

Compliance with the amended Standard requires a structured programme that addresses formulation, ingredient sourcing, labelling design, packaging logistics and distribution channel controls. The following practical checklist is drawn directly from the Standard’s text and cross-references the relevant sections.

Product classification and representation audit

Determine product classification. Review each product’s representation and label claims to determine whether it is an infant formula, follow-on formula or special medical purpose product for infants. A product may only be represented as such if it complies with the Standard (2.9.1,14; 2.9.1,43). Classify products according to the instrument’s definitions (2.9.1,3).
Document representation decisions. Maintain a record showing why a product is, or is not, represented as infant formula/follow-on/SMP, with examples of labelling, marketing materials and distribution practice.

Composition and ingredient compliance

Check energy density, protein and fat ranges. Ensure formulations fall within required energy (2510-2930 kJ/L) and macronutrient ranges (2.9.1,5(1); 2.9.1,6(2)-(3); 2.9.1,7(1)). Use the S29 calculation references for energy, protein and vitamin A (2.9.1,4(2)).
Verify permitted protein sources. Use only permitted proteins: cow, goat, sheep milk; soy protein isolate; or partially hydrolysed proteins of these sources (2.9.1,6(1); 2.9.1,33(1)).
Meet amino acid and fatty acid minima/maxima. Ensure L-amino acids meet S29,3 minima and that fatty acid profiles comply with 2.9.1,7 and related S29,4 tables.
Cap prebiotic fibres. If adding inulin-type fructans or galacto-oligosaccharides ensure caps are observed (2.9.1,12; 2.9.1,40).
Monitor specific prohibitions. Check for detectable gluten and free nucleotide-5′-monophosphates limits (2.9.1,13; 2.9.1,41).
Handle novel foods appropriately. For retail infant formula, confirm conditions in 1.5.1,3(2) are met before including novel foods. For SMP products, document necessity for novel food inclusion as required by 2.9.1,35.

Ingredient forms and permits

Use permitted forms. Add vitamins, minerals, electrolytes and other nutritive substances only in permitted forms listed in S29,23 and S29,9 (2.9.1,10; 2.9.1,38). If using substances listed in S29,9A, meet the conditions in Column 3 (2.9.1,10A).
Retain certificates of analysis and supplier declarations that substantiate permitted forms and absence of prohibited residues or contaminants.

Labelling and packaging production

Prescribed names and front-of-pack placement. Use prescribed names “Infant formula” or “Follow-on formula” on the front of pack and state protein source adjacent to the name (2.9.1,16; 2.9.1,20(1)-(2)). Avoid using the word ‘milk’ as the sole protein descriptor (2.9.1,20(3)).
Required warnings and statements. Implement the exact warning statements and “Important Notice” text as specified, and place required statements for product age suitability on the front of pack (2.9.1,21(1)-(4)).
Preparation and storage directions. Include the detailed directions and pictorial instructions required by 2.9.1,21(5)-(8), noting exceptions for ready-to-drink products (2.9.1,21(6)).
Nutrition information format. Produce the nutrition information table in the format and order in S29,10 with correct headings and units, and include required additional columns for powdered or concentrated forms if you opt to provide them (2.9.1,24; 2.9.1,25(2), (7)).
Scoop inclusion. Ensure powdered packages include a measuring scoop unless they are single serve sachets (2.9.1,17).
Print size. Set warning statement type sizes according to net weight thresholds (2.9.1,22).
Prohibited content. Ensure labels do not contain pictures of infants, idealising images, prohibited words like ‘humanised’ or HMO, or other banned ingredient or nutritional comparisons as specified (2.9.1,28(1)(a)-(f), (i)-(l)). For SMP labels replicate the prohibitions in 2.9.1,45.
Optional ingredient listing format. For added vitamins and minerals, list under subheadings “Vitamins” and “Minerals” if relying on the optional format in 2.9.1,23. Confirm compliance with 1.2.4,5 and 1.2.4,8 exceptions.

Special medical purpose product procedures

Sales channel compliance. If a product is an SMP, implement procedures to ensure sales to consumers occur only through permitted channels: medical practitioners, dietitians, medical practices, pharmacies, responsible institutions, or majority sellers meeting 2.9.1,31(2) criteria. Document customer types and sales volumes to demonstrate compliance.
SMP labelling. Prepare SMP labels to include medical purpose statements, precautions, age group statements, and an explicit note where the product is intended for sole source nutrition that the product is not for parenteral use and identifies any nutrient modifications (2.9.1,50(g)(i)-(ii)).
Inner package and transportation outer compliance. Ensure inner packages and transportation outers carry the specific minimal information required by 2.9.1,54 and 2.9.1,55.

Quality assurance, testing and sampling

Test plans and averaging. Adjust sampling and averaging methods to comply with S29 calculation approaches and avoid the averaging method prohibited under 2.9.1,26. Maintain laboratory evidence for nutrient declarations, fluoride content and any prohibited substance absence.
Retain documentation. Keep batch records, COAs, supplier declarations, and testing results that substantiate compositional claims, presence or absence of lactose (for lactose-free claims under 2.9.1,47), and allowable nutrient levels.

Marketing and claims control

Review marketing materials. Ensure all marketing and promotional materials avoid prohibited claims and phrases identified in 2.9.1,28 and 2.9.1,46. Align promotional claims with what is expressly permitted by the Code.

Inventory and supply chain management

Transition window planning. Use the 60 month transition window to phase in new packaging and formulations (clause 4(2)). Track inventories pre- and post-commencement and plan production runs accordingly.
Multi-jurisdiction strategy. If supplying New Zealand and Australia, maintain separate SKUs or packaging as needed because New Zealand has opted out (clause 4 note).

Training and governance

Staff training. Train regulatory affairs, label approval, quality assurance and sales teams on the new Standard’s detailed rules, especially around representation and SMP sales restrictions.
Legal review. Have legal counsel review labels, claims and distribution arrangements against the Standard and cross-referenced Code sections, and document legal advice.

Record-keeping and audit trail

Maintain an auditable trail tying product labels to specific batches and to the legislative requirements (section references, S29 table references, calculation methods). This supports defence in any compliance checks or enforcement action.

Start small and test. Before wide release, perform a compliance mock inspection against the Standard: verify front-of-pack text location, nutrition table format, scoop inclusion, and that compositional COAs match declared values. Where SMP claims or novel ingredients are present, maintain a dossier demonstrating medical purpose necessity and any clinical, safety or regulatory approvals relied upon.

Food Standards (Proposal P1028 – Infant Formula) Variation

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What it does

Current sections

Food Standards (Proposal P1028 – Infant Formula) Variation

Source text: opening excerpt

1 Food Standards (Proposal P1028 – Infant Formula) Variation

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply