Federal Register of Legislation - Australian Government

Primary content

Standard 2.9.1 Food Standards as amended, taking into account amendments up to Australia New Zealand Food Standards Code – Amendment No. 101 – 2008
This Standard is reserved for the standards of infant formula products.
Administered by: Health
Registered 07 Jan 2010
Start Date 14 Aug 2008
End Date 08 Oct 2008
Date of repeal 01 Mar 2016
Repealed by Australia New Zealand Food Standards Code - Standard 5.1.1 - Revocation and Transitional Provisions - 2014 revision

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.

 

Additionally, recommended guidelines regarding vitamins and minerals are contained at the end of this 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.

 

Table of Provisions

 

Division 1 – General Provisions

 

Subdivision 1 – Interpretation

1            Definitions

2            Interpretation

 

Subdivision 2 – Calculations

3            Calculation of energy

4            Calculation of protein

5            Calculation of potential renal solute load

 

Subdivision 3 – General compositional requirements

6            Restrictions and prohibitions

7            Permitted nutritive substances

8            Limit on nucleotide 5’-monophosphates

9            Lactic acid cultures

10          Limit on aluminium

 

Subdivision 4 – General labelling and packaging requirements

11          Representations of food as infant formula product

12          Prescribed names

13          Requirement for a measuring scoop

14          Required warnings, directions and statements

15          Print and package size

16          Declaration of nutrition information

17          Date marking and storage instructions


18          Statement of protein source

19          Statement on dental fluorosis

20          Prohibited representations

 

Division 2 – Infant Formula and Follow-on Formula

21          Composition

22          Protein

23          Fat

24          Vitamins, minerals and electrolytes

 

Division 3 – Infant Formula Products for Special Dietary Use

 

Subdivision 1 – Infant formula products formulated for premature or low birthweight infants

25          Composition and labelling

26          Additional labelling

 

Subdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions

27          Composition

28          Claims

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 –

 

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.


infant means a person under the age of 12 months.

 

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.

 

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.

 

Editorial note:

 

The intent of this definition is to limit the addition of ingredients to infant formula product to ingredients that would be considered to be foods.  The addition of an ingredient that is not considered to be a food is prohibited unless specifically permitted elsewhere in this Standard.

 

Standard 1.5.1 contains prohibitions and restrictions relating to novel foods and novel food ingredients.  Nothing contained in this Standard permits infant formula products to contain novel foods or novel food ingredients that are not permitted in Standard 1.5.1.

 

lactose free formula and low lactose formula means infant formula products which satisfy the needs of lactose intolerant infants.

 

medium chain triglycerides means triacylglycerols which contain predominantly the saturated fatty acids designated by 8:0 and 10:0.

 

pre-term formula means an infant formula product specifically formulated to satisfy particular needs of infants born prematurely or of low birthweight.

 

protein substitute means L-amino acids and/or the hydrolysate of one or more of the proteins on which infant formula product is normally based.

 

soy-based formula means an infant formula product in which soy protein isolate is the sole source of protein.

 

Editorial 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 –

 

Formula

 

For milk proteins and their partial protein hydrolysates -

 

              Protein content = nitrogen content x 6.38; or

 

In any other case –

 

              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 –

 

Formula

 

Potential renal solute load in mOsm/100 kJ = [Na (mg/100 kJ) /23] + [Cl (mg/100 kJ) /35]

+ [K (mg/100 kJ) /39] + [P avail (mg/100 kJ)/ 31] + [N (mg/100 kJ) /28)].

 

In this formula

 

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 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 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 for claim per   100 kJ

Maximum amount     per 100 kJ

Choline

Choline chloride

Choline bitartrate

1.7 mg

7.1 mg

Inositol

Inositol

1.0 mg

9.5 mg

Taurine

Taurine

0.8 mg

3 mg

L-carnitine

L-carnitine

0.21 mg

0.8 mg

Cytidine 5’-monophosphate

Cytidine 5’-monophosphate

Cytidine 5’-monophosphate sodium salt

0.22 mg

0.6 mg

Uridine 5’-monophosphate

Uridine 5’-monophosphate

Uridine 5’-monophosphate sodium salt

0.13 mg

0.42 mg

Adenosine 5’-monophosphate

Adenosine 5’-monophosphate

Adenosine 5’-monophosphate

sodium salt

0.14 mg

0.38 mg

Guanosine 5’-monophosphate

Guanosine 5’-monophosphate

Guanosine 5’-monophosphate sodium salt

0.04 mg

0.12 mg

Inosine 5’-monophosphate

Inosine 5’-monophosphate

Inosine 5’-monophosphate

sodium salt

0.08 mg

0.24 mg

 

8            Limit on nucleotide 5’-monophosphates

 

Infant formula product must contain no more than 3.8 mg/100 kJ of nucleotide 5’-monophosphates.

 

Editorial 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.

 

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.

 

Editorial 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.

 

(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.

 

Editorial 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.

 

Editorial 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.

 

Editorial 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 mg 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

 

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)           the name of a lactose free formula or a low lactose formula; or

(ii)          a statement of ingredients; or

(iii)          a nutrition information statement; or

 

(g)          subject to Division 3, a representation that the food is suitable for a particular condition, disease or disorder.

 

Editorial 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 formula

1.3 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

12 mg

Isoleucine

21 mg

Leucine

42 mg

Lysine

30 mg

Cyst(e)ine & 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 cyst(e)ine 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 a-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

a-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

 

Editorial note:

 

Standard 1.3.4 contains specifications for Docosahexaenoic acid (DHA) rich oil derived from the algae Crypthecodinium cohnii and Arachidonic acid (ARA) rich oil derived from the fungus Mortierella alpina.

 

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 mg

43 mg

Vitamin D

0.25 mg

0.63 mg

Vitamin C

1.7 mg

 

Thiamin

10 mg

 

Riboflavin

14 mg

 

Preformed Niacin

130 mg

 

Vitamin B6

9 mg

36 mg

Folate

2 mg

 

Pantothenic acid

70 mg

 

Vitamin B12

0.025 mg

 

Biotin

0.36 mg

 

Vitamin E

0.11 mg

1.1 mg


Table to subclause 24(1) (continued)

 

Column 1

Column 2

Column 3

Nutrient

Minimum amount per 100 kJ

Maximum amount per 100 kJ


Vitamin K

1 mg

 

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 mg

10 mg

Copper

14 mg

43 mg

Zinc

0.12 mg

0.43 mg

Manganese

0.24 mg

24.0 mg

Selenium

0.25 mg

1.19 mg

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.

 

Editorial 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          Claims

 

Where a label contains a claim that the infant formula product is suitable for infants with metabolic, immunological, renal, hepatic or malabsorptive conditions, then the label on the package of infant formula product must include a statement indicating –

 

(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

12 mg

Isoleucine

21 mg

Leucine

42 mg

Lysine

30 mg

Cyst(e)ine & 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 cyst(e)ine 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 mg per 100 kJ and no more than 2.0 mg per 100 kJ; and

(b)          molybdenum in an amount of no less than 0.36 mg per 100 kJ and no more than 3.0 mg per 100 kJ.

 

Editorial 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 hydrochloride

pyridoxine-5’-phosphate

Folate

folic acid

Pantothenic acid

calcium pantothenate

 

dexpanthenol

Vitamin B12

cyanocobalamin

 

hydroxocobalamin

Biotin

d-Biotin

Vitamin E

dl-a-tocopherol

 

d-a-tocopherol concentrate

 

tocopherols concentrate, mixed

 

d-a-tocopheryl acetate

 

dl-a-tocopheryl acetate

 

d-a-tocopheryl acid succinate

 

dl-a-tocopheryl succinate

Vitamin K

vitamin K1, as phylloquinone

(phytonadione)

 

phytylmenoquinone


SCHEDULE 1 (continued)

 

Permitted forms of vitamins, minerals and electrolytes in infant formula products

 

Calcium

calcium carbonate

 

calcium chloride

 

calcium citrate

 

calcium gluconate

 

calcium glycerophosphate

 

calcium hydroxide

 

calcium lactate

 

calcium oxide

 

calcium phosphate, dibasic

 

calcium phosphate, monobasic

 

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


SCHEDULE 1 (continued)

 

Permitted forms of vitamins, minerals and electrolytes in infant formula products

 

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

 

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 amount

per 100 kJ

Vitamins

 

Vitamin C

5.4 mg

Thiamin

48 mg

Riboflavin

86 mg

Preformed Niacin

480 mg

Folate

8.0 mg

Pantothenic acid

360 mg

Vitamin B12

0.17 mg

Vitamin K

5.0 mg

Biotin

2.7 mg

Minerals

 

Calcium

33 mg

Phosphorus

22 mg

Manganese

7.2 mg for infant formula products regulated by Division 3, Subdivision 2 only

Chromium

2.0 mg

Molybdenum

3 mg

 

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


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

Vitamin A

mg

mg

Vitamin B6

mg

mg

Vitamin B12

mg

mg

Vitamin C

mg

mg

Vitamin D

mg

mg

Vitamin E

mg

mg

Vitamin K

mg

mg

Biotin

mg

mg

Niacin

mg

mg

Folate

mg

mg

Pantothenic acid

mg

mg

Riboflavin

mg

mg

Thiamin

mg

mg

 

 

 

Calcium

mg

mg

Copper

mg

mg

Iodine

mg

mg

Iron

mg

mg

Magnesium

mg

mg

Manganese

mg

mg

Phosphorus

mg

mg

Selenium

mg

mg

Zinc

mg

mg

 

 

 

Chloride

mg

mg

Potassium

mg

mg

Sodium

mg

mg

 

 

 

(insert any other nutritive substance to be declared)

g, mg, mg

g, mg, mg

*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.

 

Note:  The information in column 2 is not mandatory.


 

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