Australia New Zealand Food Standards Code - Standard 1.1A.1 - Transitional Standard for Infant Formula Products
Division 2Infant Formula Products in Australia and New Zealand
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Division 2 – Infant Formula Products in Australia and New Zealand
(1) In this Division -
(a) ‘infant’ means a person aged up to 12 months;
(b) ‘energy value’ means energy expressed in kilojoules set out opposite and in relation to each of the following dietary sources -
1 g fat yields
37 kJ
1 g protein yields
17 kJ
1 g carbohydrate, expressed as monosaccharide, yields
16 kJ;
(c) the protein content of a food to which it applies shall be calculated -
(i) in the case of a product in which the major source of protein is cows’ milk, by multiplying the nitrogen content by 6.38;
(ii) in any other case, by multiplying the nitrogen content by 6.25.
(2) (a) In this Division, infant formula is any food sold, described or advertised as an alternative to human milk for the feeding of infants. It is a product suitable for infant feeding prepared from milk of cows or other animals or other edible constituents of animal or plant origin or a mixture of all of them, save that infant formula described as ‘suitable from birth’ shall not contain cereal proteins. In the preparation of infant formula for use, the addition of water only shall be required.
(b) Infant formula may be specifically formulated to satisfy particular well-recognised dietary requirements that are a result of a specific physical or physiological condition, disease or disorder, but in all other respects shall comply with this Standard. All deviations from the requirements of this Standard necessary to suit the condition, disease or disorder shall be declared in the label on or attached to a package containing the food.
(c) A package containing infant formula powder except single serve sachets thereof shall enclose a scoop suitable for use in accordance with the directions contained in the label on or attached to the package.
(3) Infant formula when prepared in accordance with directions contained in the label on or attached to a package containing the food -
(a) shall -
(i) be free of lumps and of large, coarse particles and suitable for being fed through a soft rubber or plastic nipple;
(ii) have an energy value of not less than 2700 kJ/L and not more than 3000 kJ/L;
(iii) have an osmolality not more than 325 mOsm/kg;
(iv) not contain more than 20 mg/100 kJ of carbohydrate, other than lactose;
(v) not contain sesame oil, cottonseed oil or fats containing more than 80 g/kg fat of trans-isomer fatty acids;
Division Division 2 - Australia New Zealand Food Standards Code - Standard 1.1A.1 - Transitional Standard for Infant Formula Products - Infant Formula Products in Australia and New Zealand | Zoe
(b) shall contain -
(i) protein of one of the following formulations -
(A) not less than 450 mg of protein/100 kJ and not more than 700 mg of protein/100 kJ and not less than the concentrations, expressed in mg/100 kJ, specified opposite and in relation to the following L-amino acids -
cystine
7
histidine
9
isoleucine
19
leucine
35
lysine
26
methionine
6
phenylalanine
14
taurine
1.5
threonine
17
tryptophan
8
tyrosine
11
valine
25;
(B) not less than 700 mg of protein/100 kJ and not more than 1.2 g of protein/100 kJ and not less than the concentrations, expressed in mg/100 kJ, specified opposite and in relation to the following L-amino acids -
cystine
7
histidine
21
isoleucine
38
leucine
70
lysine
56
methionine
20
phenylalanine
37
taurine
1.5
threonine
34
tryptophan
10
tyrosine
31
valine
51;
(ii) not less than 800 mg/100 kJ and not more than 1.5 g/100 kJ of fat. The fat shall contain not more than -
(A) 150 g/kg of lauric acid;
(B) 150 g/kg of myristic acid;
(iii) not less than 70 mg/100 kJ linoleic acid in the form of glycerides, calculated as linoleic acid;
(iv) vitamins as follows -
(A) not less than 18 g/100 kJ and not more than 37 g/100 kJ of vitamin A, calculated as retinol equivalents;
(B) not less than 0.25 g/100 kJ and not more than 0.48 g/100 kJ of vitamin D, calculated as cholecalciferol;
(C) not less than -
(1) 9 g/100 kJ of vitamin B6 save infant formula containing more than 600 mg/100 kJ of protein which shall contain not less than 15 g/g protein of vitamin B6;
(2) 0.04 g/100 kJ of vitamin B12, calculated as cyanocobalamin;
(3) 1.9 mg/100 kJ of vitamin C, calculated as L-ascorbic acid and dehydroascorbic acid;
(4) 150 g/100 kJ of vitamin E, calculated as dl--tocopherol;
(5) 1 g/100 kJ of vitamin K;
(6) 0.4 g/100 kJ of biotin;
(7) 1 g/100 kJ of folate, calculated as pteroyl monoglutamic acid;
(8) 60 g/100 kJ of niacin, calculated as nicotinamide;
(9) 70 g/100 kJ of pantothenic acid;
(10) 14 g/100 kJ of riboflavin;
(11) 10 g/100 kJ of thiamin;
(v) minerals as follows -
(A) not less than 1.2 g/100 kJ and not more than 10 g/100 kJ of iodine;
(B) not less than 100 g/100 kJ and not more than 480 g/100 kJ of iron;
(C) not less than 1.4 mg/100 kJ and not more than 3.6 mg/100 kJ of magnesium;
(D) not less than 6 mg/100 kJ and not more than 25 mg/100 kJ of phosphorus, provided that the ratio of calcium to phosphorus is not less than 1.2:1 and not more than 2:1;
(E) not less than -
(1) 12 mg/100 kJ of calcium;
(2) 14 g/100 kJ of copper;
(3) 1.2 g/100 kJ of manganese;
(4) 120 g/100 kJ of zinc;
(vi) electrolytes as follows -
(A) not less than 14 mg/100 kJ and not more than 35 mg/100 kJ of chloride;
(B) not less than 20 mg/100 kJ and not more than 50 mg/100 kJ of potassium;
(C) not less than 5 mg/100 kJ of sodium;
(vii) not less than 0.27 mg/100 kJ of L-carnitine;
(c) may contain -
(i) L-amino acids as specified in clause (3)(b)(i) of this Standard;
(ii) L-carnitine;
(iii) citric acid and L(+)-lactic acid;
(iv) vitamins, minerals and electrolytes as specified in subparagraphs (iv), (v) and (vi) of paragraph (b) of this clause in the forms specified in the Table 1 in this Standard;
(v) not more than -
(A) 5 g/L of lecithin;
(B) 4 g/L in total of mono- and di-glycerides of fat-forming fatty acids;
(C) 1 g/L in total of guar gum and locust bean gum;
(D) 10 mg/L of tocopherols;
(E) in the case of liquid milk-based infant formula and liquid soy-based infant formula, 0.3 g/L of carrageenan;
(F) in the case of liquid hydrolysed protein-based infant formula and liquid amino acid-based infant formula, 1 g/L of carrageenan;
(G) in the case of hydrolysed protein-based infant formula and amino acid-based infant formula, 25 g/L in total of acetylated distarch phosphate, distarch phosphate and phosphated starch phosphate;
(H) in the case of soy-based infant formula, 5 g/L in total of acetylated distarch phosphate, distarch phosphate and phosphated starch phosphate.
(4) Microbiological standards. When examined by the methods prescribed by clause (7) of this Standard -
(a) infant formula powder shall -
(i) have a standard plate count not exceeding 1000 micro-organisms per gram;
(ii) be free from coliforms in 1 g;
(iii) be free from coagulase-positive staphylococci in 0.1 g;
(iv) be free from Salmonella in 25 g;
(v) have a Bacillus cereus count not exceeding 100 micro-organisms per gram;
(b) ultra heat treated liquid infant formula and sterilised liquid infant formula shall show no microbial growth.
(5) There shall be written in the label on or attached to a package containing infant formula -
(a) in standard type of 3 mm, the words -
‘INFANT FORMULA’
immediately followed by -
(i) in the case of infant formula that complies with the protein requirement specified in clause (3)(b)(i)(A) of this Standard the statement -
‘SUITABLE FROM BIRTH’;
(ii) in the case of infant formula that complies with the protein requirement specified in clause (3)(b)(i)(B) of this Standard the statement -
‘SUITABLE ONLY FOR INFANTS AGED OVER 6 MONTHS’;
(b) subject to paragraph (5)(ba), in standard type of 3 mm, the statements -
(i) ‘ATTENTION - BREAST MILK IS BEST FOR BABIES. BEFORE YOU DECIDE TO USE AN INFANT FORMULA, CONSULT YOUR DOCTOR OR CLINIC FOR ADVICE’;
(ii) ‘WARNING - UNBOILED WATER, UNBOILED BOTTLES OR INCORRECT DILUTION CAN MAKE YOUR BABY ILL. PREPARE ONLY ONE BOTTLE AT A TIME. FOLLOW INSTRUCTIONS EXACTLY’;
(iii) ‘USING MORE OR LESS POWDER OR LIQUID CONCENTRATE THAN INDICATED WILL EITHER LEAD TO DEHYDRATION OR DEPRIVE YOUR BABY OF PROPER NUTRITION. DO NOT CHANGE PROPORTIONS WITHOUT MEDICAL ADVICE’;
(iv) ‘AFTER 4-6 MONTHS OF AGE YOUR BABY MAY NEED ADDITIONAL NOURISHMENT. CONSULT YOUR DOCTOR’;
(v) in the case of infant formula powder, except when sold in single serve sachets -
‘USE ONLY THE ENCLOSED SCOOP’;
(ba) in the case of infant formula in packages having a net weight of less than 1 kg - the statements referred to in subparagraphs (5)(b)(ii), (5)(b)(iii), (5)(b)(iv) and (5)(b)(v) in standard type of 1.5 mm;
(c) in standard type -
(i) directions as to its preparation and use using pictograms and -
(A) in the case of infant formula powder or infant formula liquid concentrate with a protein content of not more than 700 mg/100 kJ a feeding table in the form -
(B) in the case of ready-to-feed liquid infant formula with a protein content of not more than 700 mg/100 kJ, a feeding table in the form -
FEEDING TABLE
Age of infant
Volume per feed in mL
Feeds per day
up to 2 weeks
up to 1 month
up to 2 months
up to 4 months
up to 6 months
over 6 months
(C) in the case of infant formula powder or infant formula liquid concentrate with a protein content of more than 700 mg/100 kJ, a feeding table in the form -
(E) in the case of other infant formula, information on the quantity of formula required per feed and the number of feeds of formula required per day;
(ii) a nutrition information table, for infant formula prepared in accordance with the directions contained in the label in the form -
NUTRITION INFORMATION
Per 100 mL as prepared
Energy
kJ
Protein
g
Fat
g
Carbohydrate
g
Vitamin A
g
Vitamin B6
g
Vitamin B12
g
Vitamin C
mg
Vitamin D
g
Vitamin E
g
Vitamin K
g
Biotin
g
Niacin
g
Folate
g
Pantothenic acid
g
Riboflavin
g
Thiamin
g
Calcium
mg
Copper
g
Iodine
g
Iron
mg
Magnesium
mg
Manganese
g
Phosphorus
mg
Zinc
g
Chloride
mg
Potassium
mg
Sodium
mg
(iii) the statement -
‘IF CORRECTLY STORED AND MADE UP IN ACCORDANCE WITH THE DIRECTIONS CONTAINED IN THE LABEL, NO FURTHER VITAMIN OR MINERAL PREPARATIONS ARE NECESSARY’;
(iv) storage instructions covering both the period before and after it is opened;
(v) the source of protein in the product.
(6) There shall not be written in the label on or attached to a package containing infant formula -
(a) a pictorial representation of an infant;
(b) a pictorial representation that idealises the use of infant formula;
(c) the word ‘humanised’ or ‘maternalised’ or any word or words having the same or a similar effect;
(d) information relating to the nutrient content of human milk;
(e) a reference to the presence of vitamins, minerals, electrolytes or L-amino acids except in the statement of ingredients or in the nutrition information table;
(f) words claiming that the product is suitable for all infants from birth.
(6A) Notwithstanding paragraph (6)(e), where the iron content of infant formula is not less than 0.25 mg per 100 kJ, the label may include the words ‘infant formula with iron’.
(6B) The statement ‘infant formula with iron’ is not a nutrition claim for the purpose of Standard 1.2.8 of this Code.
(7) Methods of microbiological analysis. The methods set out in this clause are the prescribed methods with respect to the microbiological analysis of infant formula.
(a) Standard plate count. Proceed in accordance with the current standard method in AS 1766 Food microbiology, save that for the purpose of this method when 5 sample units each consisting of at least 100 g or more of infant formula powder are examined as detailed, the result shall be reported as ‘not exceeding 1000 micro-organisms per gram of the food’ when at least 3 of the 5 sample units have a standard plate count not exceeding 1000 micro-organisms per gram and any remaining sample units have a standard plate count not exceeding 10 000 micro-organisms per gram.
(b) Coliforms. Proceed in accordance with the current standard method in
AS 1766 Food microbiology, save that for the purpose of this method when 5 sample units each consisting of at least 100 g or more of infant formula powder are examined as detailed using an incubation temperature of 30oC the result shall be reported as ‘coliforms not detected in 1 gram of the food’ when at least 3 of the 5 sample units are free from coliforms in 1 g and any remaining sample units are free from coliforms in 0.1 g.
(c) Coagulase-positive staphylococci. Proceed in accordance with the current standard method in AS 1766 Food microbiology, save that for the purpose of this method when 5 sample units each consisting of at least 100 g or more of infant formula powder are examined as detailed, the result shall be reported as ‘coagulase-positive staphylococci not detected in 0.1 gram of the food’ when at least 4 of the 5 sample units are free from coagulase-positive staphylococci in 0.1 g and any remaining sample units are free from coagulase-positive staphylococci in 0.01 g.
(d) Salmonella. Proceed in accordance with the current standard method in AS 1766 Food microbiology, save that for the purpose of this method when 30 sample units each consisting of at least 100 g or more of infant formula powder are examined as detailed, the result shall be reported as ‘Salmonella not detected in 25 g of the food’ when no Salmonella has been detected in 25 g of each of the 30 sample units. For the purposes of this method, the sample units may be examined individually or pooled.
(e) Bacillus cereus. Proceed in accordance with the current standard method in AS 1766 Food microbiology, save that for the purposes of this method when 5 sample units each consisting of at least 100 g or more of infant formula powder are examined as detailed, the result shall be reported as ‘not exceeding 100 micro-organisms per gram of the food’ when at least 4 of the 5 sample units have a Bacillus cereus count not exceeding 100 micro-organisms per gram and the remaining sample unit has a Bacillus cereus count not exceeding 1000 micro-organisms per gram.