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澳新食品标准法典-2.9.1-婴幼儿配方食品(Infant Formula Products)

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放大字体  缩小字体 2013-07-29 15:41:18  来源:comlaw  浏览次数:5422
核心提示:该标准规定了可用作母乳替代品(以下简称“婴幼儿配方食品”)类食品的组分及标签要求。本标准适用于所有形式的婴幼儿配方食品,包括粉状的、液态浓缩或是“即饮”型。本标准还规定了针对具有特殊营养需求婴幼儿的婴幼儿配方产品。
发布单位
Department of Health and Ageing
Department of Health and Ageing
发布文号 Standard 2.9.1
发布日期 2000-12-20 生效日期 暂无
有效性状态 废止日期 暂无
备注 该标准规定了可用作母乳替代品(以下简称“婴幼儿配方食品”)类食品的组分及标签要求。本标准适用于所有形式的婴幼儿配方食品,包括粉状的、液态浓缩或是“即饮”型。本标准还规定了针对具有特殊营养需求婴幼儿的婴幼儿配方产品。
最新文本请详见   Standard 2.9.1.pdf,已更新至2014-10-30。
 
 
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
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-derived substances and galacto-oligosaccharides
(1)           Infant formula product may contain no more than –
(a)          110 mg per 100 kJ of inulin-derived substances; or
(b)          290 mg per 100 kJ of galacto-oligosaccharides; or
(c)          290 mg per 100 kJ of combined inulin-derived substances and galacto-oligosaccharides, where the inulin-derived substances 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-derived substances and galacto-oligosaccharides; or
(ii)           inulin-derived substances; 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-derived substances and galacto-oligosaccharides; or
(ii)           inulin-derived substances; 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-derived substances 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-derived substances 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.

 
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