Standard 2.9.1
Infant Formula Products
Purpose
This Standard provides for the compositional, and labelling requirements for foods intended or represented for use as a substitute for breast milk, herein referred to as ‘infant formula products’. This Standard applies to all infant formula products whether in powder, liquid concentrate or ‘ready to drink’ forms.
This Standard also provides for infant formula products intended for infants with special nutritional requirements.
There are Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of the legally binding Standard.
Standard 1.3.1 contains provisions relating to the food additives permitted in infant formula products. Standard 1.6.1 contains the microbiological limits in relation to infant formula products. Standard 1.3.4 contains specifications for permitted nucleotides and added nutrients. Standard 1.1.1 defines nutritive substances for the purposes of this Code.
See Standard 1.5.1 – Novel Foods for requirements for novel food and novel food ingredients.
Table of Provisions
Division 1 – General Provisions
Subdivision 1 – Interpretation
1 Definitions
2 Interpretation
Subdivision 2 – Calculations
3 Calculation of energy
4 Calculation of protein
5 Calculation of potential renal solute load
Subdivision 3 – General compositional requirements
6 Restrictions and prohibitions
7 Permitted nutritive substances
8 Limit on nucleotide 5’-monophosphates
9 Lactic acid cultures
9A Permitted inulin-type fructans and galacto-oligosaccharides
10 Limit on aluminium
Subdivision 4 – General labelling and packaging requirements
11 Representations of food as infant formula product
12 Prescribed names
13 Requirement for a measuring scoop
14 Required warnings, directions and statements
15 Print and package size
16 Declaration of nutrition information
17 Date marking and storage instructions
18 Statement of protein source
19 Statement on dental fluorosis
20 Prohibited representations
Division 2 – Infant Formula and Follow-on Formula
21 Composition
22 Protein
23 Fat
24 Vitamins, minerals and electrolytes
Division 3 – Infant Formula Products for Special Dietary Use
Subdivision 1 – Infant formula products formulated for premature or low birthweight infants
25 Composition and labelling
26 Additional labelling
Subdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions
27 Composition
28 Required statements for products under this Subdivision
29 Composition of lactose free and low lactose formulas
30 Claims relating to lactose free and low lactose formulas
Subdivision 3 – Infant formula products for specific dietary use based upon protein substitutes
31 Composition
32 Protein
33 Vitamins and minerals
34 Additional permitted triglycerides
Schedule 1 Permitted forms of vitamins and minerals in infant formula products
Guidelines for infant formula products
Clauses
Division 1
Subdivision 1 – Interpretation
1 Definitions
(1) The definitions in clauses 1 and 2 of Standard 1.2.8 apply to this Standard.
(2) In this Code –
infant means a person under the age of 12 months.
infant formula product means a product based on milk or other edible food constituents of animal or plant origin which is nutritionally adequate to serve as the principal liquid source of nourishment for infants.
infant formula means an infant formula product represented as a breast milk substitute for infants and which satisfies the nutritional requirements of infants aged up to four to six months.
follow-on formula means an infant formula product represented as either a breast-milk substitute or replacement for infant formula and which constitutes the principal liquid source of nourishment in a progressively diversified diet for infants aged from six months.
lactose free formula and low lactose formula means infant formula products which satisfy the needs of lactose intolerant infants.
pre-term formula means an infant formula product specifically formulated to satisfy particular needs of infants born prematurely or of low birthweight.
soy-based formula means an infant formula product in which soy protein isolate is the sole source of protein.
medium chain triglycerides means triacylglycerols which contain predominantly the saturated fatty acids designated by 8:0 and 10:0.
protein substitute means –
(a) L-amino acids; or
(b) the hydrolysate of one or more of the proteins on which infant formula product is normally based; or
(c) a combination of L-amino acids and the hydrolysate of one or more of the proteins on which infant formula product is normally based.
Note: Editorial note:
Note: Subclause 1(2) is structured to indicate that the definitions of specific infant formula products are within the more general ‘infant formula product’ definition. Therefore the usual practice of listing definitions in alphabetical order has not been applied in this subclause.
2 Interpretation
A reference to any infant formula product in the compositional provisions of this Standard is a reference to –
(a) a powdered or concentrated form of infant formula product which has been reconstituted with water according to directions; or
(b) an infant formula product in ‘ready to drink’ form.
Subdivision 2 – Calculations
3 Calculation of energy
The energy content of infant formula product, expressed in kilojoules (kJ), must be calculated using –
(a) only the energy value contributions of the fat, protein and carbohydrate ingredients of the infant formula product; and
(b) the relevant energy factors set out in Standard 1.2.8.
4 Calculation of protein
The prescribed formula for the calculation of the protein content of infant formula product for the purposes of this Standard is –
Note: Formula
Note: For milk proteins and their partial protein hydrolysates –
Note: Protein content = nitrogen content x 6.38; or
Note: In any other case –
Note: Protein content = nitrogen content x 6.25.
5 Calculation of potential renal solute load
The prescribed formula for the calculation of the potential renal solute load for the purposes of this Standard is –
Note: Formula
Note: Potential renal solute load in mOsm/100 kJ = [Na (mg/100 kJ) /23] + [Cl (mg/100 kJ) /35]
Note: + [K (mg/100 kJ) /39] + [P avail (mg/100 kJ)/ 31] + [N (mg/100 kJ) /28)].
Note: In this formula
Note: P avail = P of milk-based formula + 2/3 of P of soy-based formulas.
Subdivision 3 – General compositional requirements
6 Restrictions and prohibitions
(1) A vitamin, mineral, food additive or nutritive substance must not be added to infant formula product unless –
(a) expressly permitted by this Code; or
(b) it is naturally present in an ingredient of the infant formula product.
(2) Infant formula product must contain no detectable gluten.
7 Permitted nutritive substances
(1) Any nutritive substance listed in column 1 of the Table to this clause may be added to infant formula product provided that –
(a) the nutritive substance is in one or more of the forms specified in column 2 of the Table in relation to that substance; and
(b) the total amount of the nutritive substance in the infant formula product is no more than the added and any naturally occurring amount specified in column 4 of the Table.
(2) The label on a package of infant formula product must not include any words indicating, or any other indication, that the product contains a nutritive substance specified in column 1 or in column 2 of the Table to this clause unless the total amount of the added and any naturally occurring nutritive substance in the food is no less than the amount specified in column 3 of the Table.
Table to clause 7
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| Nutritive substance | Permitted forms | Minimum amount per 100 kJ | Maximum amount per 100 kJ |
| Adenosine 5′-monophosphate | Adenosine 5′-monophosphate | 0.14 mg | 0.38 mg |
| L-carnitine | L-carnitine | 0.21 mg | 0.8 mg |
| Choline | Choline chlorideCholine bitartrate | 1.7 mg | 7.1 mg |
| Cytidine 5′-monophosphate | Cytidine 5′-monophosphate | 0.22 mg | 0.6 mg |
| Guanosine 5’-monophosphate | Guanosine 5′-monophosphateGuanosine 5′-monophosphate sodium salt | 0.04 mg | 0.12 mg |
| Inosine 5′-monophosphate | Inosine 5′-monophosphateInosine 5′-monophosphatesodium salt | 0.08 mg | 0.24 mg |
| Lutein | Lutein from Tagetes erecta L. | 1.5 µg | 5 µg |
| Inositol | Inositol | 1.0 mg | 9.5 mg |
| Taurine | Taurine | 0.8 mg | 3 mg |
| Uridine 5′-monophosphate | Uridine 5′-monophosphate sodium salt | 0.13 mg | 0.42 mg |
8 Limit on nucleotide 5′-monophosphates
Infant formula product must contain no more than 3.8 mg/100 kJ of nucleotide 5′-monophosphates.
Note: Editorial note:
Note: Standard 1.3.4 contains specifications for nucleotides.
9 Lactic acid cultures
L(+) producing lactic acid cultures may be added to infant formula product.
9A Permitted inulin-type fructans and galacto-oligosaccharides
(1) Infant formula product may contain no more than –
(a) 110 mg per 100 kJ of inulin-type fructans; or
(b) 290 mg per 100 kJ of galacto-oligosaccharides; or
(c) 290 mg per 100 kJ of combined inulin-type fructans and galacto-oligosaccharides, where the inulin-type fructans is no more than 110 mg per 100 kJ.
(2) For subclause (1) the maximum permitted amount only applies when the substances are added. In that case the maximum permitted amount then applies to the sum of the naturally occurring and the added substances.
10 Limit on aluminium
(1) Infant formula product, other than a pre-term formula or soy-based formula product, must contain no more than 0.05 mg of aluminium per 100 mL.
(2) Pre-term formula must contain no more than 0.02 mg of aluminium per 100 mL.
(3) Soy-based formula must contain no more than 0.1 mg of aluminium per 100 mL.
Note: Editorial note:
Note: Standard 1.4.1 contains the maximum level (ML) of lead contaminant in infant formula products.
Subdivision 4 – General labelling and packaging requirements
11 Representations of food as infant formula product
A food must not be represented as an infant formula product unless it complies with this Standard.
12 Prescribed names
‘Infant Formula’ and ‘Follow-on Formula’ are prescribed names.
13 Requirement for a measuring scoop
(1) A package of infant formula product in a powdered form must contain a scoop to enable the use of the infant formula product in accordance with the directions contained in the label on the package.
(2) Subclause (1) does not apply to single serve sachets, or packages containing single serve sachets of an infant formula product in a powdered form.
14 Required warnings, directions and statements
(1) The label on a package of infant formula product must include the following warning statement –
(a) in the case of infant formula product in powdered form –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not change proportions of powder except on medical advice. Incorrect preparation can make your baby very ill’; and
(b) in the case of concentrated infant formula product –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not change proportions of concentrate except on medical advice. Incorrect preparation can make your baby very ill’; and
(c) in the case of ‘ready to drink’ infant formula product –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not dilute or add anything to this ‘ready to drink’ formula except on medical advice. Incorrect preparation can make your baby very ill’.
(2) The label on a package of infant formula product must include directions for the preparation and use of the infant formula product which include words and pictures instructing –
(a) that each bottle should be prepared individually; and
(b) that if a bottle of made up formula is to be stored prior to use, it must be refrigerated and used within 24 hours; and
(c) that potable, previously boiled water should be used; and
(d) where a package contains a measuring scoop, that only the enclosed scoop should be used; and
(e) that formula left in the bottle after a feed must be discarded.
(3) Subject to subclause (4), the label on a package of infant formula product must contain the following warning statement –
‘Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice.’;
under a heading that states –
‘Important Notice’ or any word or words having the same or similar effect.
(4) Subclause (3) does not apply to infant formula products for metabolic, immunological, renal, hepatic or malabsorptive conditions.
(5) The label on a package of an infant formula product must contain statements indicating that –
(a) the infant formula product may be used from birth, in the case of infant formula; and
(b) the infant formula product should not be used for infants aged under 6 months in the case of follow-on formula; and
(c) except in the case of packages of pre-term formula, it is recommended that infants over the age of 6 months should be offered foods in addition to the infant formula product.
15 Print and package size
(1) Where an infant formula product is in a package having a net weight of more than 500 g, the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than 3 mm.
(2) Where an infant formula product is in a package having a net weight of 500 g or less the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than
1.5 mm.
16 Declaration of nutrition information
(1) The label on a ‘ready to drink’ infant formula product must include a statement, which may be in the form of a table, that contains the following information –
(a) the average energy content expressed in kJ per 100 mL; and
(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mL; and
(c) the average amount of each vitamin, mineral and any other nutritive substance permitted by this Standard expressed in weight per 100 mL; and
(d) when added, the average amount of –
(i) a combination of inulin-type fructans and galacto-oligosaccharides; or
(ii) inulin-type fructans; or
(iii) galacto-oligosaccharides
expressed in weight per 100 mL.
(2) The label on a powdered or concentrated form of infant formula product must include a statement, which may be in the form of a table that contains the following information –
(a) the average energy content expressed in kJ per 100 mL of infant formula product that has been reconstituted according to directions; and
(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mL of infant formula product that has been reconstituted according to directions; and
(c) the average amount of each vitamin, mineral and any other nutritive substance permitted by this Standard expressed in weight per 100 mL of infant formula product that has been reconstituted according to directions; and
(d) a declaration –
(i) of the weight of one scoop in the case of powdered infant formula; and
(ii) of the proportion of powder or concentrate required to reconstitute the formula according to directions; and
(e) when added, the average amount of –
(i) a combination of inulin-type fructans and galacto-oligosaccharides; or
(ii) inulin-type fructans; or
(iii) galacto-oligosaccharides
expressed in weight per 100 mL when the product is reconstituted in accordance with directions.
Note: Editorial note:
Note: As a guide to how nutrition information may be presented, see the Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of the legally binding Standard.
17 Date marking and storage instructions
(1) Paragraphs 2(1)(c) and (d) of Standard 1.2.5 do not apply to this Standard.
(2) A label on a package of infant formula product must contain storage instructions covering the period after it is opened.
Note: Editorial note:
Note: The full range of climatic conditions that exist in Australia and New Zealand may need to be considered when determining valid and appropriate storage instructions.
18 Statement of protein source
The label on a package of infant formula product must contain a statement of the specific source, or sources, of protein in the infant formula product immediately adjacent to the name of the infant formula product.
Note: Editorial note:
Note: Standard 1.2.2 requires that all food be labelled with its name. The requirement in clause 18 of this Standard applies only to the name on the label on the product in accordance with the requirement in Standard 1.2.2.
19 Statement on dental fluorosis
(1) An infant formula product must comply with subclause (2) where it contains –
(a) more than 17 µg of fluoride per 100 kJ prior to reconstitution, in the case of powdered or concentrated infant formula product; or
(b) more than 0.15 mg of fluoride per 100 mL, in the case of ‘ready to drink’ formula.
(2) The label on a package of infant formula product referred to in subclause (1) must contain statements –
(a) indicating that consumption of the formula has the potential to cause dental fluorosis; and
(b) recommending that the risk of dental fluorosis should be discussed with a medical practitioner or other health professional.
20 Prohibited representations
(1) The label on a package of infant formula product must not contain –
(a) a picture of an infant; or
(b) a picture that idealises the use of infant formula product; or
(c) the word ‘humanised’ or ‘maternalised’ or any word or words having the same or similar effect; or
(d) words claiming that the formula is suitable for all infants; or
(e) information relating to the nutritional content of human milk; or
(f) subject to clause 28, a reference to the presence of any nutrient or nutritive substance, except for a reference to a nutrient or nutritive substance in –
(i) accordance with clause 30 – Claims relating to lactose free formula or low lactose formulas; or
(ii) the statement of ingredients in accordance with Standard 1.2.4 – Labelling of Ingredients; or
(iii) the nutrition information statement in accordance with clause 16 of this Standard – Declaration of nutrition information; or
(g) subject to Division 3, a representation that the food is suitable for a particular condition, disease or disorder.
(2) Subject to clause 28, the label on a package of infant formula product must not contain a reference to inulin-type fructans or galacto-oligosaccharides except for a reference to either substances in –
(a) the statement of ingredients in accordance with Standard 1.2.4 – Labelling of Ingredients; or
(b) the nutrition information statement in accordance with clause 16 of this Standard – Declaration of nutrition information.
Note: Editorial Note:
Note: Division 3 relates to Infant Formula Products for Special Dietary Use. Clause 28 permits labelling which varies from this clause.
Division 2 – Infant Formula and Follow-on Formula
21 Composition
(1) Infant formula and follow-on formula must –
(a) have an energy content of no less than 2500 kJ/L and no more than 3150 kJ/L in the case of infant formula, and no less than 2500 kJ/L and no more than 3550 kJ/L in the case of follow-on formula; and
(b) contain an amount of each nutrient specified in column 1 of the Table to this clause which is no less than the amount specified in column 2 of the Table and no more than the amount specified in column 3 of the Table.
Table to clause 21
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Nutrient | Minimum amount per 100 kJ | Maximum amount per 100 kJ |
| Protein | 0.45 g | 0.7 g for infant formula1.3 g for follow-on formula |
| Fat | 1.05 g | 1.5 g |
(2) Follow-on formula must have a potential renal solute load value of no more than 8 mOsm/100 kJ.
22 Protein
(1) The L-amino acids listed in column 1 of the Table to this clause must be present in infant formula and follow-on formula at the minimum level specified in column 2 of the Table, subject to subclause 2 and 3.
Table to clause 22
| Column 1 | Column 2 |
|---|---|
| L-Amino Acid | Minimum amount per 100 kJ |
| Histidine | 10 mg |
| Isoleucine | 21 mg |
| Leucine | 42 mg |
| Lysine | 30 mg |
| Cysteine, cystine and methionine | 19 mg |
| Phenylalanine & Tyrosine | 32 mg |
| Threonine | 19 mg |
| Tryptophan | 7 mg |
| Valine | 25 mg |
(2) Infant formula or follow-on formula must provide no less than –
(a) 6 mg of cysteine, cystine or combined cysteine and cystine per 100 kJ; and
(b) 17 mg phenylalanine per 100 kJ.
(3) L-amino acids listed in the Table to this clause must be added to infant formula or
follow-on formula only in an amount necessary to improve protein quality.
23 Fat
The fats in infant formula and follow-on formula must –
(a) not contain medium chain triglycerides except where a medium chain triglyceride is present in a particular infant formula or follow-on formula as the result of being –
(i) a natural constituent of a milk-based ingredient of that particular infant formula or follow-on formula or;
(ii) a processing aid used in preparations of permitted fat soluble vitamins of that particular infant formula or follow-on formula where the fat soluble vitamins have been specified in Schedule 1 to this Standard; and
(b) have a ratio of linoleic acid to \-linolenic acid of no less than 5 to 1 and no more than 15 to 1; and
(c) if specified in column 1 of the Table to this clause, comply with the limits, if any, specified in columns 2 and 3 of the Table; and
(d) have a ratio of total long chain omega 6 series fatty acids (C>= 20) to total long chain omega 3 series fatty acids (C>= 20) that is not less than 1 in an infant formula or follow-on formula which contains those fatty acids; and
(e) where long chain polyunsaturated fatty acids are present in an infant formula or follow-on formula, an eicosapentaenoic acid (20:5 n-3) content of no more than the docosahexaenoic acid (22:6 n-3) content.
Table to clause 23
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Fatty acids | Minimum % total fatty acids | Maximum % total fatty acids |
| Essential fatty acids | ||
| Linoleic acid (18:2) | 9 | 26 |
| -Linolenic acid (18:3) | 1.1 | 4 |
| Long chain polyunsaturated fatty acids | ||
| Long chain omega 6 series fatty acids (C>= 20) | 2 | |
| Arachidonic acid (20:4) | 1 | |
| Long chain omega 3 series fatty acids (C>= 20) | 1 | |
| Total trans fatty acids | 4 | |
| Erucic acid (22:1) | 1 |
Note: Editorial note:
Note: Standard 1.3.4 contains specifications for dried marine microalgae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA), oil derived from marine microalgae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA), oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA), oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA), and oil derived from marine microalgae (Ulkenia sp.) rich in docosahexaenoic acid (DHA).
24 Vitamins, minerals and electrolytes
(1) Infant formula and follow-on formula must contain the vitamins, minerals and electrolytes specified in column 1 of the Table to this subclause provided that, in relation to each vitamin, mineral or electrolyte –
(a) the added vitamin, mineral or electrolyte is in a permitted form as listed in Schedule 1; and
(b) the infant formula or follow-on formula contains no less than the amount specified in column 2 of the Table; and
(c) the infant formula or follow-on formula contains no more than the amount specified in column 3 of the Table, if any.
Table to subclause 24(1)
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Nutrient | Minimum amount per 100 kJ | Maximum amount per 100 kJ |
| Vitamins | ||
| Vitamin A | 14 µg | 43 µg |
| Vitamin D | 0.25 µg | 0.63 µg |
| Vitamin C | 1.7 mg | |
| Thiamin | 10 µg | |
| Riboflavin | 14 µg | |
| Preformed Niacin | 130 µg | |
| Vitamin B6 | 9 µg | 36 µg |
| Folate | 2 µg | |
| Pantothenic acid | 70 µg | |
| Vitamin B12 | 0.025 µg | |
| Biotin | 0.36 µg | |
| Vitamin E | 0.11 mg | 1.1 mg |
| Vitamin K | 1 µg | |
| Minerals | ||
| Chloride | 12 mg | 35 mg |
| Calcium | 12 mg | |
| Phosphorus | 6 mg | 25 mg |
| Magnesium | 1.2 mg | 4.0 mg |
| Iron | 0.2 mg | 0.5 mg |
| Iodine | 1.2 µg | 10 µg |
| Copper | 14 µg | 43 µg |
| Zinc | 0.12 mg | 0.43 mg |
| Manganese | 0.24 µg | 24.0 µg |
| Selenium | 0.25 µµg | 1.19 µg |
| Electrolytes | ||
| Sodium | 5 mg | 15 mg |
| Potassium | 20 mg | 50 mg |
(2) Infant formula and follow-on formula must contain no less than 0.5 mg of Vitamin E per g of polyunsaturated fatty acids.
(3) The ratio of calcium to phosphorus in infant formula and follow-on formula must be no less than 1.2 to 1 and no more than 2 to 1.
(4) The ratio of zinc to copper –
(a) in infant formula must be no more than 15 to 1; and
(b) in follow-on formula must be no more than 20 to 1.
Note: Editorial note:
Note: This Standard contains guidelines setting out the recommended levels of vitamins, minerals and electrolytes that as a matter of good practice should not be exceeded.
Division 3 – Infant Formula Products for Special Dietary Use
Subdivision 1 – Infant formula products formulated for premature or low birthweight infants
25 Composition and labelling
Infant formula products may be specifically formulated for premature or low birthweight infants provided that in all other respects they comply with this Standard.
26 Additional labelling
(1) The label on a package of pre-term formula must include the warning statement –
‘Suitable only for pre-term infants under specialist medical supervision’.
(2) The words ‘pre-term’ must appear as part of the name of a food standardised in this subdivision.
Subdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions
27 Composition
Infant formula products may be specifically formulated to satisfy particular metabolic, immunological, renal, hepatic or malabsorptive conditions provided that in all other respects the products comply with this Division.
28 Required statements for products under this Subdivision
The label on an infant formula product that is specifically formulated to satisfy particular metabolic, immunological, renal, hepatic or malabsorptive conditions must contain a statement that indicates –
(a) that the product is not suitable for general use and should be used under medical supervision; and
(b) the condition, disease or disorder for which the food has been specially formulated; and
(c) the nutritional modifications, if any, which have been made to the infant formula product.
29 Composition of lactose free and low lactose formulas
(1) A lactose free formula or low lactose formula must, except for the lactose content, comply with the compositional and labelling requirements which apply to the infant formula product of which they are a variety.
(2) Lactose free formula must contain no detectable lactose.
(3) Low lactose formula must contain no more than 0.3 g lactose per 100 mL of infant formula product.
30 Claims relating to lactose free and low lactose formulas
Where a label contains a claim that the infant formula product is lactose free, low lactose or words of similar import, the label on a package of lactose free or a low lactose formula product must include –
(a) the words ‘lactose free’ as part of the name of lactose free formula; and
(b) the words ‘low lactose’ as part of the name of low lactose formula; and
(c) the following statements –
(i) the amount of lactose expressed in g per 100 mL; and
(ii) the amount of galactose expressed in g per 100 mL.
Subdivision 3 – Infant formula products for specific dietary use based upon protein substitutes
31 Composition
An infant formula product for specific dietary use based upon protein substitutes must –
(a) have an energy content of no less than 2500 kJ/L and no more than 3150 kJ/L in the case of infant formula, and no less than 2500 kJ/L and no more than 3550 kJ/L in the case of follow-on formula; and
(b) have a potential renal solute load of no more than 8 mOsm per 100 kJ; and
(c) contain an amount of each nutrient specified in column 1 of the Table to this clause which is no less than the amount specified in column 2 of the Table and no more than the amount specified in column 3 of the Table.
Table to clause 31
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Nutrient | Minimum amount per 100 kJ | Maximum amount per 100 kJ |
| Protein | 0.45 g | 1.4 g |
| Fat | 0.93 g | 1.5 g |
32 Protein
(1) The protein content of an infant formula product for specific dietary use based upon protein substitutes may be in the form of protein substitute.
(2) The L-amino acids listed in column 1 of the Table to this clause must be present in infant formula product for special dietary use at the minimum level specified in column 2 of the Table, subject to subclause 3 and 4.
Table to clause 32
| Column 1 | Column 2 |
|---|---|
| L-Amino Acid | Min amount per 100 kJ |
| Histidine | 10 mg |
| Isoleucine | 21 mg |
| Leucine | 42 mg |
| Lysine | 30 mg |
| Cysteine, cystine and methionine | 19 mg |
| Phenylalanine & Tyrosine | 32 mg |
| Threonine | 19 mg |
| Tryptophan | 7 mg |
| Valine | 25 mg |
(3) Infant formula product for specific dietary use based upon protein substitutes must provide no less than –
(a) 6 mg of cysteine, cystine or combined cysteine and cystine per 100 kJ; and
(b) 17 mg phenylalanine per 100 kJ.
(4) L-amino acids listed in the Table to this clause must be added to infant formula product for specific dietary use based upon protein substitutes only in an amount necessary to improve protein quality.
33 Vitamins and minerals
An infant formula product for specific dietary use based upon protein substitutes must contain –
(a) chromium in an amount of no less than 0.35 µg per 100 kJ and no more than 2.0 µg per 100 kJ; and
(b) molybdenum in an amount of no less than 0.36 µg per 100 kJ and no more than 3.0 µg per 100 kJ.
Note: Editorial note:
Note: The provisions of clause 24 of this Standard also apply in respect of the vitamins, minerals and electrolytes permitted in an infant formula product for specific dietary use based upon protein substitutes.
34 Additional permitted triglycerides
An infant formula product for specific dietary use based upon protein substitutes may contain added medium chain triglycerides.
SCHEDULE 1
Permitted forms of vitamins, minerals and electrolytes in infant formula products
| Column 1 | Column 2 |
|---|---|
| Vitamins, Minerals and Electrolytes | Permitted Forms |
| Vitamin A | Retinol Forms |
| vitamin A (retinol) | |
| vitamin A acetate (retinyl acetate) | |
| vitamin A palmitate (retinyl palmitate) | |
| retinyl propionate | |
| Carotenoid Forms | |
| beta-carotene | |
| Vitamin C | L-ascorbic acid |
| L-ascorbyl palmitate | |
| calcium ascorbate | |
| potassium ascorbate | |
| sodium ascorbate | |
| Vitamin D | vitamin D2 (ergocalciferol) |
| vitamin D3 (cholecalciferol) | |
| vitamin D (cholecalciferol-cholesterol) | |
| Thiamin | thiamin hydrochloride |
| thiamin mononitrate | |
| Riboflavin | riboflavin |
| riboflavin-5′-phosphate, sodium | |
| Niacin | niacinamide (nicotinamide) |
| Vitamin B6 | pyridoxine hydrochloridepyridoxine-5′-phosphate |
| Folate | folic acid |
| Pantothenic acid | calcium pantothenate |
| dexpanthenol | |
| Vitamin B12 | cyanocobalamin |
| hydroxocobalamin | |
| Biotin | d-Biotin |
| Vitamin E | dl--tocopherol |
| d--tocopherol concentrate | |
| tocopherols concentrate, mixed | |
| d--tocopheryl acetate | |
| dl--tocopheryl acetate | |
| d--tocopheryl acid succinate | |
| dl--tocopheryl succinate | |
| Vitamin K | vitamin K1, as phylloquinone (phytonadione) |
| phytylmenoquinone | |
| Calcium | calcium carbonate |
| calcium chloride | |
| calcium citrate | |
| calcium gluconate | |
| calcium glycerophosphate | |
| calcium hydroxide | |
| calcium lactate | |
| calcium oxide | |
| calcium phosphate, dibasic | |
| calcium phosphate, monobasic |
SCHEDULE 1
Permitted forms of vitamins, minerals and electrolytes in infant formula products (continued)
| calcium phosphate, tribasic | |
|---|---|
| calcium sulphate | |
| Chloride | calcium chloride |
| magnesium chloride | |
| potassium chloride | |
| sodium chloride | |
| Chromium | chromium sulphate |
| Copper | copper gluconate |
| cupric sulphate | |
| cupric citrate | |
| Iodine | potassium iodate |
| potassium iodide | |
| sodium iodide | |
| Iron | ferric ammonium citrate |
| ferric pyrophosphate | |
| ferrous citrate | |
| ferrous fumarate | |
| ferrous gluconate | |
| ferrous lactate | |
| ferrous succinate | |
| ferrous sulphate | |
| Magnesium | magnesium carbonate |
| magnesium chloride | |
| magnesium gluconate | |
| magnesium oxide | |
| magnesium phosphate, dibasic | |
| magnesium phosphate, tribasic | |
| magnesium sulphate | |
| Manganese | manganese chloride |
| manganese gluconate | |
| manganese sulphate | |
| manganese carbonate | |
| manganese citrate | |
| Molybdenum | sodium molybdate VI |
| Phosphorus | calcium glycerophosphate |
| calcium phosphate, dibasic | |
| calcium phosphate, monobasic | |
| calcium phosphate, tribasic | |
| magnesium phosphate, dibasic | |
| potassium phosphate, dibasic | |
| potassium phosphate, monobasic | |
| potassium phosphate, tribasic | |
| sodium phosphate, dibasic | |
| sodium phosphate, monobasic | |
| sodium phosphate, tribasic | |
| Potassium | potassium bicarbonate |
| potassium carbonate | |
| potassium chloride | |
| potassium citrate | |
| potassium glycerophosphate | |
| potassium gluconate | |
| potassium hydroxide | |
| potassium phosphate, dibasic |
SCHEDULE 1
Permitted forms of vitamins, minerals and electrolytes in infant formula products (continued)
| potassium phosphate, monobasic | |
|---|---|
| potassium phosphate, tribasic | |
| Selenium | seleno methionine |
| sodium selenate | |
| sodium selenite | |
| Sodium | sodium bicarbonate |
| sodium carbonate | |
| sodium chloride | |
| sodium chloride iodised | |
| sodium citrate | |
| sodium gluconate | |
| sodium hydroxide | |
| sodium iodide | |
| sodium lactate | |
| sodium phosphate, dibasic | |
| sodium phosphate, monobasic | |
| sodium phosphate, tribasic | |
| sodium sulphate | |
| sodium tartrate | |
| Zinc | zinc acetate |
| zinc chloride | |
| zinc gluconate | |
| zinc oxide | |
| zinc sulphate |
GUIDELINES FOR INFANT FORMULA PRODUCTS
(These guidelines are not part of the legally binding Standard)
Guideline for maximum amount of vitamins and minerals in infant formula products
It is recommended that the quantities specified in the table below be observed as the maximum levels of vitamins and minerals in infant formula product.
| Nutrient | Recommended maximum amountper 100 kJ |
|---|---|
| Vitamins | |
| Vitamin C | 5.4 mg |
| Thiamin | 48 µg |
| Riboflavin | 86 µg |
| Preformed Niacin | 480 µg |
| Folate | 8.0 µg |
| Pantothenic acid | 360 µg |
| Vitamin B12 | 0.17 µg |
| Vitamin K | 5.0 µg |
| Biotin | 2.7 µg |
| Minerals | |
| Calcium | 33 mg |
| Phosphorus | 22 mg |
| Manganese | 7.2 µg for infant formula products regulated by Division 3, Subdivision 2 only |
| Chromium | 2.0 µg |
| Molybdenum | 3 µg |
Guideline on advice regarding additional vitamin and mineral supplementation
Manufacturers are recommended to provide an advice in the label on a package of infant formula product to the effect that consumption of vitamin or mineral preparations are not necessary.
Nutrition information table
The nutrition information contained in the label on a package of infant formula product is recommended in the following format –
NUTRITION INFORMATION
| Average amount per 100 mL made up formula *1 | Average amount per 100 g of powder (or per 100 mL for liquid concentrate) *2 | |
|---|---|---|
| Energy | kJ | kJ |
| Protein | g | g |
| Fat | g | g |
| Carbohydrate | g | g |
| Vitamin A | µg | µg |
| Vitamin B6 | µg | µg |
| Vitamin B12 | µg | µg |
| Vitamin C | mg | mg |
| Vitamin D | µg | µg |
| Vitamin E | µg | µg |
| Vitamin K | µg | µg |
| Biotin | µg | µg |
NUTRITION INFORMATION (continued)
| Average amount per 100 mL made up formula *1 | Average amount per 100 g of powder (or per 100 mL for liquid concentrate) *2 | |
|---|---|---|
| Niacin | mg | mg |
| Folate | µg | µg |
| Pantothenic acid | µg | µg |
| Riboflavin | µg | µg |
| Thiamin | µg | µg |
| Calcium | mg | mg |
| Copper | µg | µg |
| Iodine | µg | µg |
| Iron | mg | mg |
| Magnesium | mg | mg |
| Manganese | µg | µg |
| Phosphorus | mg | mg |
| Selenium | µg | µg |
| Zinc | mg | mg |
| Chloride | mg | mg |
| Potassium | mg | mg |
| Sodium | mg | mg |
| (insert any other nutritive substance or inulin-type fructans and galacto-oligosaccharides to be declared) | g, mg, µg | g, mg, µg |
*1 – Delete the words ‘made up formula’ in the case of formulas sold in ‘ready to drink’ form.
*2 – Delete this column in the case of formulas sold in ‘ready to drink’ form.
Amendment History
The Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.
These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.
About this compilation
This is a compilation of Standard 2.9.1 as in force on 30 October 2014 (up to Amendment No. 150). It includes any commenced amendment affecting the compilation to that date.
Prepared by Food Standards Australia New Zealand on 30 October 2014.
Uncommenced amendments or provisions ceasing to have effect
To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislative Instruments including or omitting those amendments and provided in the Amendment History once the date is passed.
The following abbreviations may be used in the table below:
ad = added or inserted am = amended
exp = expired or ceased to have effect rep = repealed
rs = repealed and substituted
Standard 2.9.1 was published in the Commonwealth of Australia Gazette No. P 30 on 20 June 2002 as part of Amendment No. No. 60 (F2008B00798 – 19 December 2008) and has been amended as follows:
| Clause affected | A’ment No. | FRLI registrationGazette | Commencement(Cessation) | How affected | Description of amendment |
|---|---|---|---|---|---|
| Purpose | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | am | Purpose relating to infant formula products. |
| Table of Provs | 78 | F2005L0124626 May 2005FSC2026 May 2005 | 26 May 2005 | rs | New heading for clause 24. |
| Table of Provs | 138 | F2013L0005014 Jan 2013FSC8018 Jan 2013 | 18 Jan 2013 | am | Amendment relating to the heading of clause 28. |
| Table of Provs | 150 | F2014L0142728 Oct 2014FSC9230 Oct 2014 | 30 Oct 2014 | ad | Reference to clause 9A to reflect previous amendment. |
| 1 | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | am | Definition of ‘protein substitute’. |
| 1(2) | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | rep | Editorial notes in the definitions. |
| 1(2) | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | ad | Editorial note relating to infant formula product definitions after the subclause. |
| 1(2) | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | rs | Subclause. |
| 7 | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | rep | Editorial note before the Table to clause 7.. |
| 7(1)(b) | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | ad | After ‘the total amount of the’ inserting ‘added and any naturally occurring’. |
| 7(2) | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | ad | After ‘the total amount of the’ inserting ‘added and any naturally occurring’. |
| Table to clause 7 | 108 | F2009L0206628 May 2009FSC5028 May 2009 | 28 May 2009 | am | Column headings. |
| Table to clause 7 | 108 | F2009L0206628 May 2009FSC5028 May 2009 | 28 May 2009 | ad | Entry for lutein. |
| Table to clause 7 | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | rs | Entries for adenosine 5′-monophosphate, cytidine 5′-monophosphate and uridine 5′-monophosphate. |
| 9A | 105 | F2009L0007615 Jan 2009FSC4715 Jan 2009 | 15 Jan 2009 | ad | New clause related to inulin-derived substances and galacto-oligosaccharides. |
| 9A | 142 | F2013L0146530 July 2013FSC841 Aug 2013 | 1 Aug 2013 | rs | ‘Inulin-derived substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions. |
| 16 | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | ad | Editorial note after the clause relating to the Guideline at the end of this Standard. |
| 16 | 142 | F2013L0146530 July 2013FSC841 Aug 2013 | 1 Aug 2013 | rs | ‘Inulin-derived substances’ replaced with ‘inulin-type fructans’. |
| 16(1) | 105 | F2009L0007615 Jan 2009FSC4715 Jan 2009 | 15 Jan 2009 | rs | Consequential amendments related to inulin-derived substances and galacto-oligosaccharides. |
| 16(2)(e) | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | rs | Clarification of the intent of the paragraph. |
| 17 | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | am | Editorial note after the clause. |
| 20 | 105 | F2009L0007615 Jan 2009FSC4715 Jan 2009 | 15 Jan 2009 | rs | Consequential amendments related to inulin-derived substances and galacto-oligosaccharides. |
| 20(1)(f) | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | rs | Clarification of the intent of the paragraph. |
| 20(2) | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | rs | Clarification of the intent of the subparagraphs. |
| 20(2) | 142 | F2013L0146530 July 2013FSC841 Aug 2013 | 1 Aug 2013 | rs | ‘Inulin-derived substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions. |
| 22 | 72 | F2008B0081924 Dec 2008FSC1420 May 2004 | 20 May 2004 | rs | References for ‘cysteine’ amended to ‘cyst(e)ine’. |
| 22(2)(a | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | rs | ‘Cyst(e)ine & methionine’ replaced with ‘cysteine, cystine and methionine’ and related consequential amendments. |
| Table to clause 22 | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | rep | Editorial note after the Table. |
| Table to clause 22 | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | rs | ‘Cyst(e)ine & methionine’ replaces with ‘cysteine, cystine and methionine’ and related consequential amendments. |
| Table to clause 22 | 141 | F2013L0081121 May 2013FSC8323 May 2013 | 23 May 2013 | rs | Entry for histidine. |
| 23(a) | 88 | F2006L032705 Oct 2006FSC305 Oct 2006 | 5 Oct 2006 | am | Reference to medium chain triglycerides. |
| 23(d) | 95 | F2007L0470013 Dec 2007FSC3713 Dec 2007 | 13 Dec 2007 | am | Long chain omega 3 and 6 series fatty acid ratio. |
| Table to clause 23 | 101 | F2008L0305814 Aug 2008FSC4314 Aug 2008 | 14 Aug 2008 | rep | Editorial notes. |
| Table to clause 23 | 124 | F2011L014508 July 2011FSC6611July 2011 | 11 July 2011 | rs | Editorial note after the Table arising from amendments to specifications in Standard 1.3.4. |
| 24 | 78 | F2005L0124626 May 2005FSC2026 May 2005 | 26 May 2005 | rs | Heading of clause to include reference to electrolytes. |
| 24(1), Table to s’clause 24(1) | 78 | F2005L0124626 May 2005FSC2026 May 2005 | 26 May 2005 | rs | Amend subclause and Editorial note after the clause to treat potassium and sodium as electrolytes, rather than minerals. |
| 27 | 99 | F2008L0229726 June 2008FSC4126 June 2008 | 26 June 2008 | rs | To clarify operation of the clause. |
| 28 | 138 | F2013L0005014 Jan 2013FSC8018 Jan 2013 | 18 Jan 2013 | am | Consequential amendment relating to Standard 1.2.7. |
| 32 | 72 | F2008B0081924 Dec 2008FSC1420 May 2004 | 20 May 2004 | rs | References for ‘cysteine’ amended to ‘cyst(e)ine’. |
| 32(3)(a) | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | rs | ‘Cyst(e)ine & methionine’ replaced with ‘cysteine, cystine and methionine’ and related consequential amendments. |
| 32(4) | 67 | F2008B0081424 Dec 2008FSC931 July 2003 | 31 July 2003 | am | Typographical error. |
| Table to, clause 32 | 103 | F2008L037419 Oct 2008FSC459 Oct 2008 | 9 Oct 2008 | rs, am | ‘Cyst(e)ine & methionine’ replaced with ‘cysteine, cystine and methionine’ and related consequential amendments. |
| Table to clause 32 | 141 | F2013L0081121 May 2013FSC8323 May 2013 | 23 May 2013 | rs | Entry for histidine. |
| Sch 1 | 72 | F2008B0081924 Dec 2008FSC1420 May 2004 | 20 May 2004 | ad | Reference to sodium selenate. |
| Sch 1 | 88 | F2006L032705 Oct 2006FSC305 Oct 2006 | 5 Oct 2006 | rep | ‘dehydrate’ from the listing for the permitted form of molybdenum. |
| Infant Formula Prods G’lines | 105 | F2009L0007615 Jan 2009FSC4715 Jan 2009 | 15 Jan 2009 | rs | Guidelines |
| Infant Formula Prods G’lines | 105 | F2009L0007615 Jan 2009FSC4715 Jan 2009 | 15 Jan 2009 | rep | Editorial note after the Guidelines after the table. |
| Infant Formula Prods G’lines | 142 | F2013L0146530 July 2013FSC841 Aug 2013 | 1 Aug 2013 | rs | ‘Inulin-derived substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions. |