Australia New Zealand Food Standards Code - Standard 1.1A.1 - Transitional Standard for Infant Formula Products

Division 1 - Application

(1A) For the matters regulated in this Standard, food produced in or imported into Australia, must comply with Division 2 of this Standard or Standard 2.9.1, but not a combination of both.

(1B) For the matters regulated in this Standard, food produced in or imported into New Zealand, must comply with Division 2 or 3 in this Standard or Standard 2.9.1, but not a combination of any of these.

(1C) This Standard ceases to have effect two years from the commencement of Standard 2.9.1.

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 -

(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;

(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 -

(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 -

(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 -

FEEDING TABLE

<table cellspacing="0" cellpadding="0" style="border:0.75pt solid #000000; border-collapse:collapse"><tbody><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td colspan="2" style="width:227pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="text-align:center; line-height:normal"><span>Age of infant</span></p></td><td colspan="2" style="width:227pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="text-align:center; line-height:normal"><span>Quantities per feed</span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="text-align:center; line-height:normal"><span>Feeds per day</span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td colspan="2" style="width:227pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span>Previously boiled water in mL</span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span>Level measuring scoops or number of sachets or, as the case may be, volume of liquid concentrate in mL</span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>up to 2 weeks</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>up to 1 month</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>up to 2 months</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>up to 4 months</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>up to 6 months</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span><span>over 6 months</span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr><tr><td style="width:102pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:100pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:119pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td><td style="width:77pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="line-height:normal"><span></span></p></td></tr></tbody></table>

(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

(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 -

FEEDING TABLE

<table cellspacing="0" cellpadding="0" style="border:0.75pt solid #000000; border-collapse:collapse"><tbody><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:208pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; text-align:center; line-height:normal"><span>Age of infant</span></p></td><td colspan="2" style="width:208pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; text-align:center; line-height:normal"><span>Quantities per feed</span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; text-align:center; line-height:normal"><span>Feeds per day</span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:208pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:208pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:78.4pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:121.6pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-top:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:78.4pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Previously boiled water in mL</span></p></td><td style="width:121.6pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Level measuring scoops or number of sachets or, as the case may be, volume of liquid concentrate in mL</span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Formula</span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Other feeds</span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:78.4pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:121.6pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:78.4pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:121.6pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-top:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span><span>over 6 months</span></p></td><td style="width:78.4pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:121.6pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:78.4pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:121.6pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr></tbody></table>

(D) in the case of ready-to-feed liquid infant formula with a protein content of more than 700 mg/100 kJ, a feeding table in the form -

FEEDING TABLE

<table cellspacing="0" cellpadding="0" style="border:0.75pt solid #000000; border-collapse:collapse"><tbody><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Age of infant</span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Volume per feed in mL</span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Feeds per day</span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td colspan="2" style="width:106pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-top:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Formula</span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span>Other feeds</span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-top:0.75pt solid #000000; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-top:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span><span>over 6 months</span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr><tr><td style="width:81pt; border-right:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:211pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:50pt; border-right:0.75pt solid #000000; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td><td style="width:48pt; border-left:0.75pt solid #000000; padding-right:3.62pt; padding-left:3.62pt; vertical-align:top"><p class="11" style="margin-right:0.3pt; line-height:normal"><span></span></p></td></tr></tbody></table>

(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

(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.

Division 3 - Infant Formula and Follow-On Formula (New Zealand Only)

(8) In this Division, infant formula shall be a food in liquid or powdered form intended for use as a substitute for human milk as the sole source of nutrition for an infant.

(9) In this Division, follow-on formula shall be a food in a liquid or powdered form intended for use as a substitute for human milk by infants and young children who are in good health and who are aged over 6 months, and constituting the principal liquid element in a progressively diversified diet.

(10) Infant formula and follow-on formula shall be nutritionally adequate to promote normal growth and development when used in accordance with the directions for use on the label.

(11) Infant formula and follow-on formula may contain any of the following -

(a) the following thickening agents -

(b) the following emulsifiers -

(c) the following acidity regulators -

(d) the following antioxidants -

neither of which shall be present in a proportion exceeding 10 ppm, calculated, in the case of an infant formula or follow-on formula that requires dilution or preparation before consumption, after such dilution or preparation;

(e) vitamins and minerals specified in Column 1 of Table 2 in the form specified in relation to that vitamin or mineral, and choline;

(f) the following amino acids -

(g) The amino acid carnitine, if the protein sources of the infant formula or follow-on formula do not contain carnitine.

(12) No food additives except those specified in clause (11) shall be present in an infant formula or follow-on formula as a result of carry over from raw materials or other ingredients.

(13) The name of the food shall be either ‘infant formula’ or ‘follow-on formula’, as the case may be, or any appropriate designation indicating the true nature of the food.

(14) The label on each package of an infant formula or follow-on formula shall bear a statement of -

(a) The quantity of carbohydrate, protein, and fat in the food, expressed in g; and

(b) The energy content of the food, expressed in kJ; and

(c) The quantity of each vitamin and mineral in the food expressed in mg or mcg.

(15) The particulars required by clause (14) shall be stated -

(a) Per 100 g or 100 ml of infant formula or follow-on formula as sold; and

(b) Per stated volume of infant formula or follow-on formula when prepared according to the directions on the label.

(16) The label on each package of infant formula shall bear the words ‘An infant being fed this formula does not require additional vitamin or mineral supplements’, or words of similar meaning.

(17) The label on each package of follow-on formula shall bear the words ‘An infant or young child being fed this formula does not require additional vitamin or mineral supplements", or words of similar meaning.’

(18) Each package of an infant formula or follow-on formula shall be labelled or embossed with a date mark, which shall be in the form ‘best before (followed by a date)’, or in the form ‘use by (followed by a date)’, in accordance with Standard 1.2.5.

(19) In the case of an infant formula or follow-on formula that has a shelf life of more than 90 days, the date used in the date mark shall state at least the month in the year expressed as a numeral or an abbreviation of the month using a minimum of 3 letters, followed by the year expressed as a numeral using either 2 digits or 4 digits.

(20) The label on each package of infant formula or follow-on formula shall bear a statement of the storage directions for the food before and after opening the package, and clear directions for the use of the food.

(21) In the case of an infant formula or follow-on formula that is a powder to be reconstituted and is not packaged in a single-serving sachet bearing a statement of the weight of the contents, a scoop or measure shall be included in the product container.

Table 1

Forms of vitamins, minerals and electrolytes that may be added to Formula

Table 2

Vitamins, minerals and electrolytes that may be added to Formula