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
Division Division 3 - Australia New Zealand Food Standards Code - Standard 2.9.1 - Infant Formula Products - Infant Formula Products for Special Dietary Use | Zoe
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: 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.