Federal Register of Legislation - Australian Government

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Standard 2.9.1 Food Standards as amended, taking into account amendments up to Food Standards (Proposal P1033 – Code Maintenance XII) Variation
Administered by: Health
Registered 31 Oct 2014
Start Date 30 Oct 2014
End Date 01 Mar 2016
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Repealed by Australia New Zealand Food Standards Code - Standard 5.1.1 - Revocation and Transitional Provisions - 2014 revision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.

 

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.

 

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 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 chloride

Choline bitartrate

1.7 mg

7.1 mg

Cytidine 5′-monophosphate

Cytidine 5′-monophosphate

0.22 mg

0.6 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

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.

 


 

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.

 

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.

 

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; 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.

 

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 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.


 

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

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 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 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.

 

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           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.

 


 

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

 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 amount

per 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 registration

Gazette

Commencement

(Cessation)

How affected

Description of amendment

Purpose

103

F2008L03741

9 Oct 2008

FSC45

9 Oct 2008

 

9 Oct 2008

am

Purpose relating to infant formula products.

Table of Provs

78

F2005L01246

26 May 2005

FSC20

26 May 2005

26 May 2005

rs

New heading for clause 24.

Table of Provs

138

F2013L00050

14 Jan 2013

FSC80

18 Jan 2013

18 Jan 2013

am

Amendment relating to the heading of clause 28.

Table of Provs

150

F2014L01427

28 Oct 2014

FSC92

30 Oct 2014

 

30 Oct 2014

ad

Reference to clause 9A to reflect previous amendment.

1

124

F2011L01450

8 July 2011

FSC66

11July 2011

11 July 2011

am

Definition of ‘protein substitute’.

1(2)

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

rep

Editorial notes in the definitions.

1(2)

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

ad

Editorial note relating to infant formula product definitions after the subclause.

1(2)

103

F2008L03741

9 Oct 2008

FSC45

9 Oct 2008

 

9 Oct 2008

rs

Subclause.

7

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

rep

Editorial note before the Table to clause 7..

7(1)(b)

103

F2008L03741

9 Oct 2008

FSC45

9 Oct 2008

9 Oct 2008

ad

After ‘the total amount of the’ inserting ‘added and any naturally occurring’.

7(2)

103

F2008L03741

9 Oct 2008

FSC45

9 Oct 2008

9 Oct 2008

ad

After ‘the total amount of the’ inserting ‘added and any naturally occurring’.

Table to clause 7

108

F2009L02066

28 May 2009

FSC50

28 May 2009

28 May 2009

am

Column headings.

Table to clause 7

108

F2009L02066

28 May 2009

FSC50

28 May 2009

28 May 2009

ad

Entry for lutein.

Table to clause 7

124

F2011L01450

8 July 2011

FSC66

11July 2011

 

11 July 2011

rs

Entries for adenosine 5′-monophosphate, cytidine 5′-monophosphate and uridine 5′-monophosphate.

9A

105

F2009L00076

15 Jan 2009

FSC47

15 Jan 2009

15 Jan 2009

ad

New clause related to inulin-derived substances and galacto-oligosaccharides.

9A

142

F2013L01465

30 July 2013

FSC84

1 Aug 2013

 

1 Aug 2013

rs

‘Inulin-derived  substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions.

16

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

ad

Editorial note after the clause relating to the Guideline at the end of this Standard.

16

142

F2013L01465

30 July 2013

FSC84

1 Aug 2013

1 Aug 2013

rs

‘Inulin-derived  substances’ replaced with ‘inulin-type fructans’.

16(1)

105

F2009L00076

15 Jan 2009

FSC47

15 Jan 2009

15 Jan 2009

rs

Consequential amendments related to inulin-derived substances and galacto-oligosaccharides.

16(2)(e)

124

F2011L01450

8 July 2011

FSC66

11July 2011

 

11 July 2011

rs

Clarification of the intent of the paragraph.

17

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

 

14 Aug 2008

am

Editorial note after the clause.

20

105

F2009L00076

15 Jan 2009

FSC47

15 Jan 2009

15 Jan 2009

rs

Consequential amendments related to inulin-derived substances and galacto-oligosaccharides.

20(1)(f)

124

F2011L01450

8 July 2011

FSC66

11July 2011

11 July 2011

rs

Clarification of the intent of the paragraph.

20(2)

124

F2011L01450

8 July 2011

FSC66

11July 2011

11 July 2011

rs

Clarification of the intent of the subparagraphs.

20(2)

142

F2013L01465

30 July 2013

FSC84

1 Aug 2013

 

1 Aug 2013

rs

‘Inulin-derived  substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions.

22

72

F2008B00819

24 Dec 2008

FSC14

20 May 2004

20 May 2004

rs

References for ‘cysteine’ amended to ‘cyst(e)ine’.

22(2)(a

103

F2008L03741

9 Oct 2008

FSC45

9 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

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

rep

Editorial note after the Table.

Table to clause 22

103

F2008L03741

9 Oct 2008

FSC45

9 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

F2013L00811

21 May 2013

FSC83

23 May 2013

 

23 May 2013

rs

Entry for histidine.

23(a)

88

F2006L03270

5 Oct 2006

FSC30

5 Oct 2006

5 Oct 2006

am

Reference to medium chain triglycerides.

23(d)

95

F2007L04700

13 Dec 2007

FSC37

13 Dec 2007

13 Dec 2007

am

Long chain omega 3 and 6 series fatty acid ratio.

Table to clause 23

101

F2008L03058

14 Aug 2008

FSC43

14 Aug 2008

14 Aug 2008

rep

Editorial notes.

Table to clause 23

124

F2011L01450

8 July 2011

FSC66

11July 2011

 

11 July 2011

rs

Editorial note after the Table arising from amendments to specifications in Standard 1.3.4.

24

78

F2005L01246

26 May 2005

FSC20

26 May 2005

26 May 2005

rs

Heading of clause to include reference to electrolytes.

24(1), Table to s’clause 24(1)

78

F2005L01246

26 May 2005

FSC20

26 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

F2008L02297

26 June 2008

FSC41

26 June 2008

 

26 June 2008

rs

To clarify operation of the clause.

28

138

F2013L00050

14 Jan 2013

FSC80

18 Jan 2013

 

18 Jan 2013

am

Consequential amendment relating to Standard 1.2.7.

32

72

F2008B00819

24 Dec 2008

FSC14

20 May 2004

20 May 2004

rs

References for ‘cysteine’ amended to ‘cyst(e)ine’.

32(3)(a)

103

F2008L03741

9 Oct 2008

FSC45

9 Oct 2008

9 Oct 2008

rs

‘Cyst(e)ine & methionine’ replaced with ‘cysteine, cystine and methionine’ and related consequential amendments.

32(4)

67

F2008B00814

24 Dec 2008

FSC9

31 July 2003

31 July 2003

am

Typographical error.

Table to, clause 32

103

F2008L03741

9 Oct 2008

FSC45

9 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

F2013L00811

21 May 2013

FSC83

23 May 2013

 

23 May 2013

rs

Entry for histidine.

Sch 1

72

F2008B00819

24 Dec 2008

FSC14

20 May 2004

20 May 2004

ad

Reference to sodium selenate.

Sch 1

88

F2006L03270

5 Oct 2006

FSC30

5 Oct 2006

 

5 Oct 2006

rep

‘dehydrate’ from the listing for the permitted form of molybdenum.

Infant Formula Prods G’lines

105

F2009L00076

15 Jan 2009

FSC47

15 Jan 2009

15 Jan 2009

rs

Guidelines

Infant Formula Prods G’lines

105

F2009L00076

15 Jan 2009

FSC47

15 Jan 2009

15 Jan 2009

rep

Editorial note after the Guidelines after the table.

Infant Formula Prods G’lines

142

F2013L01465

30 July 2013

FSC84

1 Aug 2013

 

1 Aug 2013

rs

‘Inulin-derived  substances’ replaced with ‘inulin-type fructans’ and consequential amendment to the Table of Provisions.