Food Standards (Proposal P1028 – Infant Formula Products – Consequential Amendments) Variation

The Board of Food Standards Australia New Zealand gives notice of the making of this variation under section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the date specified in clause 3 of this variation.

Dated 12 September 2024

Christel Leemhuis, General Manager Risk Assessment and Science Branch

Delegate of the Board of Food Standards Australia New Zealand

Note:

This variation will be published in the Commonwealth of Australia Gazette No. FSC 171 on 13 September 2024. This means that this date is the gazettal date for the purposes of clause 3 of the variation.

1 Name

This instrument is the Food Standards (Proposal P1028 – Infant Formula – Consequential Amendments) Variation.

2 Variation to standards in the Australia New Zealand Food Standards Code

(1) The Schedules to this instrument vary Standards in the Australia New Zealand Food Standards Code.

(2) Each Standard that is specified in a Schedule to this instrument is amended as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

3 Commencement

This instrument commences immediately after the commencement of the Food Standards (Proposal P1028 – Infant Formula) Variation.

4 Effect of the variations made by this instrument

(1) Section 1.1.1—9 of Standard 1.1.1 does not apply to the variations made by this instrument.

(2) During the transition period, a food product may be sold if the product complies with one of the following:

(a) the Code as in force without the variations made by the instruments; or

(b) the Code as amended by the variations made by the instruments.

(3) For the purposes of this clause:

(a) the instruments means:

(i) this instrument; and

(ii) the Food Standards (Proposal P1028 – Infant Formula) Variation;

(b) the transition period means the period commencing on the date of commencement of the Food Standards (Proposal P1028 – Infant Formula) Variation and ending 60 months after that date of commencement.

Schedule 1

Schedule 29—Special purpose foods

[1] Sections S29—2 to S29—10

Repeal the sections, substitute:

S29—2 Infant formula products—calculation of energy content

(1) For paragraph 2.9.1—4(2)(a), the energy content of infant formula product must be calculated using:

(a) the energy contributions of the following *components only:

(i) fat; and

(ii) protein; and

(iii) carbohydrate; and

(b) the relevant energy factors set out in section S11—2.

(2) The energy content of an infant formula product must be expressed in kilojoules.

S29—2A Infant formula products—calculation of protein content

For paragraph 2.9.1—4(2)(b), the protein content of infant formula product must be calculated by multiplying the nitrogen content of the product by a nitrogen‑to‑protein conversion factor of 6.25.

S29—2B Infant formula products—calculation of vitamin A content

For paragraph 2.9.1—4(2)(c), the vitamin A content of infant formula products must be calculated using only the retinol forms of vitamin A prescribed in Column 1 of Table S29—23.

S29—3 Infant formula products—L-amino acids that must be present

For subsection 2.9.1—6(5) and section 2.9.1—33, the table is:

L-amino acids that must be present in infant formula products

L-amino acid	Minimum amount per 100 kJ
Cysteine	9 mg
Histidine	10 mg
Isoleucine	22 mg
Leucine	40 mg
Lysine	27 mg
Methionine	6 mg
Phenylalanine	19 mg
Threonine	18 mg
Tryptophan	8 mg
Tyrosine	18 mg
Valine	22 mg

S29—4 Infant formula products—limits on fatty acids

For paragraphs 2.9.1—7(1)(g) and 2.9.1—34(1)(g), the table is:

Limits on fatty acids that may be present in infant formula products

Column 1	Column 2
Substance	Maximum amount per 100 kJ
Docosahexaenoic acid	12 mg
Total trans fatty acids	Not more than 4% of the total fatty acids
Erucic acid (22:1)	Not more than 1% of the total fatty acids

S29—5 Vitamins, minerals, electrolytes and other substances required in infant formula and special medical purpose product for infants

For sections 2.9.1—7(2)(b)(i), 2.9.1—8(1), 2.9.1—34(2)(b) and 2.9.1—36(1), the table is:

Vitamins, minerals, electrolytes and other nutritive substances required in infant formula and special medical purpose product for infants

Column 1	Column 2	Column 3	Column 4
Substance	Minimum amount per 100 kJ	Maximum amount per 100 kJ	Guidance upper level per 100 kJ (see Note)
Vitamins
Vitamin A	14 μg RE	43 μg RE
Vitamin D	0.24 μg	0.63 μg
Vitamin C	1.7 mg		17 mg
Thiamin	10 μg		72 µg
Riboflavin	14.3 μg		120 µg
Niacin	72 μg		359 µg
Vitamin B6	8 μg		42 µg
Folic acid	2.4 μg		12 µg
Pantothenic acid	96 μg		478 µg
Vitamin B12	0.02 μg		0.36 µg
Biotin	0.24 μg		2.4 µg
Vitamin E	0.14 mg α-TE		1.2 mg α-TE
Vitamin K	0.24 μg		6 µg
Minerals
Calcium	12 mg		35 mg
Phosphorus	6 mg		24 mg
Magnesium	1.2 mg		3.6 mg
Iron	0.14 mg	0.48 mg
Iodine	2.4 μg		14 µg
Copper	8 μg		29 µg
Zinc	0.12 mg		0.36 mg
Manganese	0.24 μg		24 μg
Selenium	0.48 μg		2.2 µg
Electrolytes
Chloride	12 mg	38 mg
Sodium	4.8 mg	14 mg
Potassium	14 mg	43 mg
Other essential substances
Choline	1.7 mg		12 mg
L-carnitine	0.3 mg		0.8 mg
Inositol	1 mg		10 mg

Note It is recommended that infant formula and a special medical purpose product for infants contain a substance listed in Column 1 of the table in an amount that is not more than the amount (if any) specified for that substance in Column 4 of the table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose no significant risks on the basis of current scientific knowledge. These levels are values derived on the basis of meeting nutritional requirements of infants and an established history of apparent safe use. These Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of infant formulas or special medical purpose product for infants; or due to technological reasons.

S29—6 Vitamins, minerals and electrolytes required in follow-on formula

For subparagraph 2.9.1—7(2)(b)(ii) and subsection 2.9.1—8(2), the table is:

Vitamins, minerals and electrolytes required in follow-on formula

Column 1	Column 2	Column 3	Column 4
Vitamin, mineral or electrolyte	Minimum amount per 100 kJ	Maximum amount per 100 kJ	Guidance upper level per 100 kJ (see Note)
Vitamins
Vitamin A	14 μg RE	43 μg RE
Vitamin D	0.24 μg	0.72 μg
Vitamin C	1.7 mg		17 mg
Thiamin	10 μg		72 µg
Riboflavin	14.3 μg		120 µg
Niacin	72 μg		359 µg
Vitamin B6	8 μg		42 µg
Folic acid	2.4 μg		12 µg
Pantothenic acid	96 μg		478 µg
Vitamin B12	0.02 μg		0.36 µg
Biotin	0.24 μg		2.4 µg
Vitamin E	0.14 mg α-TE		1.2 mg α-TE
Vitamin K	0.24 μg		6 µg
Minerals
Calcium	12 mg		43 mg
Phosphorus	6 mg		24 mg
Magnesium	1.2 mg		3.6 mg
Iron	0.24 mg	0.48 mg
Iodine	2.4 μg		14 µg
Copper	8 μg		29 µg
Zinc	0.12 mg		0.36 mg
Manganese	0.24 μg		24 μg
Selenium	0.48 μg		2.2 µg
Electrolytes
Chloride	12 mg	38 mg
Sodium	4.8 mg	14 mg
Potassium	14 mg	43 mg

Note It is recommended that follow-on formula contain a substance listed in Column 1 of the table in an amount that is not more than the amount (if any) specified for that substance in column 4 of the table. The amounts specified are Guidance Upper Levels and are recommended upper levels for nutrients which pose no significant risks on the basis of current scientific knowledge. These levels are values derived on the basis of meeting nutritional requirements of infants and an established history of apparent safe use. The Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of follow-on formula or due to technological reasons.

S29—7 Optional nutritive substances in infant formula and special medical purpose product for infants

For subsection 2.9.1—9(1) and section 2.9.1—37, the table is set out below.

Optional nutritive substances in infant formula and special medical purpose product for infants

Column 1	Column 2	Column 3
Substance	Minimum amount per 100 kJ	Maximum amount per 100 kJ
2′-fucosyllactose permitted for use by Standard 1.5.2 3′-sialyllactose sodium salt permitted for use by Standard 1.5.2 6′-sialyllactose sodium salt permitted for use by Standard 1.5.2 A combination of 2′-fucosyllactose and difucosyllactose, permitted for use by Standard 1.5.2		96 mg 8 mg 16 mg 96 mg
A combination of: 2′-fucosyllactose permitted for use by Standard 1.5.2; and lacto-N-neotetraose permitted for use by Standard 1.5.2		96 mg which contains not more than 24 mg of lacto-N-neotetraose
Adenosine-5′-monophosphate		0.36 mg
Cytidine-5′-monophosphate		0.6 mg
Guanosine-5′monophosphate		0.4 mg
Inosine-5′-monophosphate		0.24 mg
Lactoferrin lacto-N-tetraose permitted for use by Standard 1.5.2		40 mg 32 mg
Lutein	1.5 µg	5 µg
Taurine		2.9 mg
Uridine-5′-monophosphate		0.42 mg

S29—8 Optional nutritive substances in follow-on formula

For subsection 2.9.1—9(2), the table is set out below.

Optional nutritive substances in follow-on formula

Column 1	Column 2	Column 3	Column 4
Substance	Minimum amount per 100 kJ	Maximum amount per 100 kJ	Guidance upper level per 100 kJ (see Note)
2′-fucosyllactose permitted for use by Standard 1.5.2 3′-sialyllactose sodium salt permitted for use by Standard 1.5.2 6′-sialyllactose sodium salt permitted for use by Standard 1.5.2 A combination of 2′-fucosyllactose and difucosyllactose, permitted for use by Standard 1.5.2		96 mg 8 mg 16 mg 96 mg
A combination of: 2′-fucosyllactose permitted for use by Standard 1.5.2; and lacto-N-neotetraose permitted for use by Standard 1.5.2		96 mg which contains not more than 24 mg of lacto-N-neotetraose
Adenosine-5′-monophosphate		0.36 mg
L-carnitine	0.3 mg
Choline			12 mg
Cytidine-5′-monophosphate		0.6 mg
Guanosine-5′-monophosphate		0.4 mg
Inosine-5′-monophosphate		0.24 mg
Lactoferrin lacto-N-tetraose permitted for use by Standard 1.5.2		40 mg 32 mg
Lutein	1.5 µg	5 µg
Inositol			10 mg
Taurine		2.9 mg
Uridine-5′-monophosphate		0.42 mg

Note It is recommended that follow-on formula contain a substance listed in Column 1 of the table in an amount that is not more than the amount (if any) specified for that substance in Column 4 of the table. The amounts specified in Column 4 are Guidance Upper Levels and are recommended upper levels for nutrients which pose no significant risks on the basis of current scientific knowledge. These levels are values derived on the basis of meeting nutritional requirements of infants and an established history of apparent safe use. The Guidance Upper Levels should not be exceeded unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of follow-on formula or due to technological reasons.

S29—9 Permitted forms of nutritive substances in infant formula products

For paragraphs 2.9.1—10(b) and 2.9.1—38(b), the table is set out below.

Permitted forms for nutritive substances used in infant formula products

Substance	Permitted forms
2′-fucosyllactose permitted for use by Standard 1.5.2 3′-sialyllactose sodium salt permitted for use by Standard 1.5.2 6'-sialyllactose sodium salt permitted for use by Standard 1.5.2 A combination of 2′-fucosyllactose and difucosyllactose, permitted for use by Standard 1.5.2	2′-fucosyllactose 3′-sialyllactose sodium salt 6'-sialyllactose sodium salt 2'-fucosyllactose and difucosyllactose
A combination of: 2′-fucosyllactose permitted for use by Standard 1.5.2; and lacto-N-neotetraose permitted for use by Standard 1.5.2	2′-fucosyllactose and lacto-N-neotetraose
Adenosine-5′-monophosphate	Adenosine-5′- monophosphate
L-carnitine	L-carnitine L-carnitine hydrochloride L-carnitine tartrate
Choline	Choline chloride
	Choline bitartrate Choline Choline citrate Choline hydrogen tartrate
Cytidine-5′-monophosphate	Cytidine-5′-monophosphate
Guanosine-5′-monophosphate	Guanosine-5′-monophosphate
	Guanosine-5′-monophosphate sodium salt
Inosine-5′-monophosphate	Inosine-5′-monophosphate
	Inosine-5′-monophosphate sodium salt
Lactoferrin lacto-N-tetraose permitted for use by Standard 1.5.2	Bovine lactoferrin lacto-N-tetraose
Lutein	Lutein from Tagetes erecta L.
Inositol	Myo-inositol
Taurine	Taurine
Uridine-5′-monophosphate	Uridine-5′-monophosphate sodium salt

Note Section S29—23 lists the permitted forms of vitamins, minerals and electrolytes in infant formula products.

S29—9A Infant formula products—conditions on use of permitted nutritive substances

The table for this section is as follows:

Conditions of use for permitted nutritive substances

Column 1	Column 2	Column 3
Substance	Permitted Form	Conditions of use
Lactoferrin	Bovine lactoferrin	During the exclusive use period, may only be sold under the brand Synlait for *use as a nutritive substance in an infant formula product. For the purposes of condition 1 above, exclusive use period means the period commencing on the date of gazettal of the Food Standards (Application A1253 – Bovine Lactoferrin in Infant Formula Products) Variation and ending 15 months after that date.

S29—10 Required format for a nutrition information statement

The table to this section is:

NUTRITION INFORMATION
	Average quantity per 100 mL prepared formula
Energy	kJ
Protein	g
— Whey*	g
— Casein*	g
Fat	g
— Long chain polyunsaturated fatty acids*
— Docosahexaenoic acid (DHA)*	mg
— Eicosapentaenoic acid (EPA)*	mg
— Arachidonic acid (ARA)*	mg
Carbohydrate	g
Vitamins
Vitamin A	μg
Vitamin B6	μg
Vitamin B12	μg
Vitamin C	mg
Vitamin D	μg
Vitamin E	mg
Vitamin K	μg
Biotin	μg
Niacin (B3)	μg
Folate	μg
Pantothenic acid (B5)	μg
Riboflavin (B2)	μg
Thiamin (B1)	μg
Minerals
Calcium	mg
Copper	μg
Iodine	μg
Iron	mg
Magnesium	mg
Manganese	μg
Phosphorus	mg
Selenium	μg
Zinc	mg
Chloride	mg
Potassium	mg
Sodium	mg
Other nutrients*
Choline*	mg
Inositol*	mg
L-carnitine*	mg
Additional
(insert any other substance used as a nutritive substance; or inulin-type fructans and / or galacto-oligosaccharides, to be declared)	g, mg, μg

Note: *See the following.

Entries and amounts for the following need only be included when stated in accordance with subsection 2.9.1—24(4), 2.9.1—24(5) and paragraph 2.9.1—25(6)(d): whey; casein; docosahexaenoic acid; eicosapentaenoic acid; arachidonic acid.

The heading ‘Other nutrients’ need only be included when required by subparagraph 2.9.1—25(2)(d)(ii) and paragraph 2.9.1—25(4)(a).

The heading ‘Long chain polyunsaturated fatty acids’ need only be included when required by paragraph 2.9.1—25(6)(a).

Entries and amounts for choline, inositol, L-carnitine are included under the heading ‘Other nutrients’ when required by paragraph 2.9.1—25(4)(a) and under the heading ‘Additional’ when required by paragraph 2.9.1—25(4)(b).

S29—10A Example of a nutrition information statement including quantities expressed as sold

For subsection 2.9.1—25(7), an example nutrition information statement including information expressed in accordance with subsection 2.9.1—24(7) is:

NUTRITION INFORMATION
	Average quantity per 100 mL prepared formula	Quantity per 100 g powder (or 100 mL liquid concentrate)
Energy	kJ	kJ
Protein	g	g
— Whey	g	g
— Casein	g	g
Fat	g	g
— Long chain polyunsaturated fatty acids
— Docosahexaenoic acid (DHA)	mg	mg
— Eicosapentaenoic acid (EPA)	mg	mg
— Arachidonic acid (ARA)	mg	mg
Carbohydrate	g	g
Vitamins
Vitamin A	μg	μg
Vitamin B6	μg	μg
Vitamin B12	μg	μg
Vitamin C	mg	mg
Vitamin D	μg	μg
Vitamin E	mg	mg
Vitamin K	μg	μg
Biotin	μg	μg
Niacin (B3)	μg	μg
Folate	μg	μg
Pantothenic acid (B5)	μg	μg
Riboflavin (B2)	μg	μg
Thiamin (B1)	μg	μg
Minerals
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
Other nutrients
Choline	mg	mg
Inositol	mg	mg
L-carnitine	mg	mg
Additional
(insert any other substance used as a nutritive substance; or inulin-type fructans and / or galacto-oligosaccharides, to be declared)	g, mg, μg	g, mg, μg

[2] After section S29—22

Insert:

S29—23 Permitted forms of vitamins, minerals and electrolytes in infant formula products, food for infants, formulated meal replacements (vitamin K) and food for special medical purposes

For sections 2.9.1—10(a), 2.9.1—38(a), 2.9.2—4, 2.9.2—5, 2.9.2—6, 2.9.3—3(2)(c)(iii) and 2.9.5—6, the table is:

Permitted forms of vitamins, minerals and electrolytes in infant formula products, food for infants, formulated meal replacements (vitamin K) and food for special medical purposes

Vitamin, mineral or electrolyte	Permitted forms
Vitamin A
Retinol forms	vitamin A (retinol)
	vitamin A acetate (retinyl acetate)
	vitamin A palmitate (retinyl palmitate)
	retinyl propionate
Provitamin A 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
	D-panthenol
	calcium D-pantothenate
	sodium D-pantothenate
Vitamin B12	cyanocobalamin
	hydroxocobalamin
Biotin	d-biotin
Vitamin E	dl-α-tocopherol
	d-α-tocopherol concentrate
	tocopherols concentrate, mixed
	d-α-tocopheryl acetate
	dl-α-tocopheryl acetate
	d-α-tocopheryl acid succinate
	dl-α-tocopheryl succinate
Vitamin K	Vitamin K1 as phylloquinone (phytonadione)
Calcium	calcium carbonate
	calcium chloride
	calcium citrate
	calcium gluconate
	calcium glycerophosphate
	calcium hydroxide
	calcium lactate
	calcium oxide
	calcium phosphate, dibasic
	calcium phosphate, monobasic
	calcium phosphate, tribasic
	calcium sulphate
Chloride	calcium chloride
	magnesium chloride
	potassium chloride
	sodium chloride
Chromium	chromium sulphate
Copper	copper gluconate
	cupric sulphate
	cupric citrate cupric carbonate
Iodine	potassium iodate
	potassium iodide
	sodium iodide
Iron	ferric ammonium citrate ferric citrate
	ferric pyrophosphate ferrous bisglycinate
	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
	magnesium hydroxide carbonate
	magnesium hydroxide
	magnesium salts of citric acid
Manganese	manganese carbonate manganese chloride manganese citrate
	manganese gluconate
	manganese sulphate
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
	potassium phosphate, monobasic
	potassium phosphate, tribasic potassium L-lactate
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 citrate (zinc citrate dihydrate or zinc citrate trihydrate)
	zinc gluconate zinc lactate
	zinc oxide
	zinc sulphate

Schedule 2

Standard 1.1.2—Definitions used throughout the Code

[1] Subsection 1.1.2—2(3)

Insert:

inner package, in relation to a special medical purpose product for infants, means an individual package of the food that is:

(a) contained and sold within another package that is labelled in accordance with Division 4 of Standard 2.9.1; and

(b) not designed for individual sale, other than a sale by a *responsible institution to a patient or resident of the responsible institution.

Example An example of an inner package is an individual sachet (or sachets) of a powdered food contained within a box that is fully labelled, being a box available for retail sale.

[2] Subsection 1.1.2—2(3) (definition of medium chain triglycerides)

Repeal the definition.

[2A] Subsection 1.1.2—2(3) (definition of protein substitute)

Repeal the definition.

[3] Subsection 1.1.2—2(3) (paragraph (c) of the definition of warning statement)

Repeal the paragraph, substitute:

[4] Subsection 1.1.2—3(2) (definitions—particular foods)

Insert:

special medical purpose product for infants means an infant formula product that is:

represented as being:

specially formulated for the dietary management of infants who have medically determined nutrient requirements (such as limited or impaired capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food); and

suitable to constitute either the sole or principal liquid source of nourishment where dietary management cannot medically be achieved without use of the product; and

(iii) for the dietary management of a medically diagnosed disease, disorder or condition of an infant; and

intended to be used under medical supervision; and
not suitable for general use.

[5] Subsection 1.1.2—3(2) (definition of follow-on formula)

Repeal the definition, substitute:

follow-on formula means an infant formula product that is represented as:

(a) either a breast milk substitute or replacement for infant formula; and

(b) being suitable to constitute the principal liquid source of nourishment in a progressively diversified diet for infants from the age of 6 months.

[6] Subsection 1.1.2—3(2) (definition of infant formula)

Repeal the definition, substitute:

infant formula means an infant formula product that is represented as:

(a) a breast milk substitute for infants; and

(b) satisfying by itself the nutritional requirements of infants under the age of 6 months.

[7] Subsection 1.1.2—3(2) (definition of infant formula product)

Repeal the definition, substitute:

infant formula product means a product based on milk or other edible food constituents of animal or plant origin which is represented as nutritionally adequate to serve by itself either as the sole or principal liquid source of nourishment for infants, depending on the age of the infant.

[8] Subsection 1.1.2—3(2) (definition of pre-term formula)

Repeal the definition.

[8A] Subsection 1.1.2—8(2) (definition of novel food)

Repeal the subsection, substitute:

(2) Any of the following:

(a) the presence of a food in a food for special medical purposes;

(b) the presence of a food in a special medical purpose product for infants;

(d) the use of a food as a special medical purpose product for infants;

does not constitute a history of human consumption in Australia or New Zealand in relation to that food for the purposes of this section

Standard 1.2.3—Information requirements – warning statements, advisory statements and declarations

[9] Paragraph 1.2.3—6(4)(b)

Repeal the paragraph, substitute

(b) a special medical purpose product for infants.

[10] Note 2 to subsection 1.2.3—6(4)

Repeal the note, substitute:

Note 2 Division 4 of Standard 2.9.1 applies to a special medical purpose product for infants and sets out compositional and labelling requirements for such food.

Standard 1.3.1—Food Additives

[11] Subsection 1.3.1—3(2)

After ‘any food’, insert ‘(other than an infant formula product)’

[12] Paragraph 1.3.1—4(6)(k)

Repeal the paragraph, substitute:

(k) rosemary extract is calculated as the sum of carnosic acid and carnosol;

(l) phosphoric acid and phosphates are calculated as phosphorus.

Standard 1.5.1—Novel Foods

[13] Note to subsection 1.5.1—2(2) (Definition of novel food)

Repeal subsection (2) of the definition, substitute:

(2) Any of the following:

(a) the presence of a food in a food for special medical purposes;

(b) the presence of a food in a special medical purpose product for infants;

(d) the use of a food as a special medical purpose product for infants;

do not constitute a history of human consumption in Australia or New Zealand in relation to that food for the purposes of this section.

[13A] Section 1.5.1—3

Repeal the section, substitute:

1.5.1—3 Sale of novel foods

(1) Despite paragraphs 1.1.1—10(5)(b) and (6)(f), a food offered for retail sale (other than an infant formula product) may consist of, or have as an ingredient, a *novel food if:

(a) the novel food is listed in the table to section S25—2; and

(b) any conditions of use specified in the corresponding row of that table are complied with.

Note Novel foods are added to the table to section S25—2 by variations to the Code. When added for the first time, the conditions may include some that apply to the novel food only during the first 15 months after gazettal of the variation. Conditions may also deal with matters such as the following:

· the need for preparation or cooking instructions, warning statements or other advice;

· the need to meet specific requirements of composition or purity;

· the class of food within which the food must be sold;

· during the first 15 months after gazettal, the brand under which the food may be sold.

(2) Despite paragraphs 1.1.1—10(5)(b) and (6)(f), an infant formula product for retail sale may consist of, or have as an ingredient or a *component, a novel food only if:

(a) the novel food is listed in the table to section S25—2; and

(b) the presence of that novel food in the infant formula product is expressly permitted by that table; and

Standard 2.9.2—Food for infants

[14] Section 2.9.2—4

Omit ‘section S29—7’ (wherever occurring), substitute ‘section S29—23’.

[15] Section 2.9.2—5

Omit ‘section S29—7’ (wherever occurring), substitute ‘section S29—23’.

[16] Subsection 2.9.2—6(3)

Omit ‘section S29—7’, substitute ‘section S29—23’.

Standard 2.9.3—Formulated meal replacements and formulated supplementary foods

[17] Subparagraph 2.9.3—3(2)(c)(iii)

Omit ‘section S29—7’, substitute ‘section S29—23’.

Standard 2.9.5—Food for special medical purposes

[18] Paragraph 2.9.5—6(1)(b)

Omit ‘section S29—7’, substitute ‘section S29—23’.

Schedule 8—Food additive names and code numbers (for statement of ingredients)

[19] The table to section S8—2 (food additive names—alphabetical listing)

Insert:

dl-Alpha-tocopherol	307c
Potassium hydroxide	525
Sodium hydroxide	524

[20] The table to section S8—2 (food additive names—numerical listing)

Insert in numerical order:

307c	dl-Alpha-tocopherol
524	Sodium hydroxide
525	Potassium hydroxide

Schedule 15—Substances that may be used as food additives

[21] The table to section S15—5 (food classes 13.1, 13.1.1, 13.1.2 and 13.1.3)

Repeal the food classes, substitute:

0B13.1 Infant formula products
270	Lactic acid	GMP
300	Ascorbic acid	50 mg/L		See Note 1, below.
301	Sodium ascorbate	50 mg/L 75 mg/L		See Note 1, below. May only be added to polyunsaturated fatty acid preparations
302	Calcium ascorbate	50 mg/L		See Note 1, below.
304	Ascorbyl palmitate	50 mg/L		See Note 1, below.
304	Ascorbyl palmitate	10 mg/L
307b	Tocopherols concentrate, mixed	10 mg/L
307b	Tocopherols concentrate, mixed	30 mg/L		See Note 1, below
307c	dl-Alpha-tocopherol	10 mg/L
307c	dl-Alpha-tocopherol	30 mg/L		See Note 1, below
308	Gamma-tocopherol	10 mg/L
309	Delta-tocopherol	10 mg/L
322	Lecithin	5 000 mg/L
330	Citric acid	GMP
331	Sodium citrates	GMP
332	Potassium citrates	GMP
333	Calcium citrates	0.1 mg/L		As calcium, may only be added as part of a nutrient preparation
338	Phosphoric acid	450 mg/L
339	Sodium phosphates	450 mg/L
340	Potassium phosphates	450 mg/L
407	Carrageenan	300 mg/L		Only in a liquid product
410	Locust bean (carob bean) gum	1 000 mg/L
412	Guar gum	1 000 mg/L		Only in a liquid product that contains hydrolysed protein
414	Gum arabic (acacia)	10 mg/L		May only be added as part of a nutrient preparation
440	Pectins	10 000 mg/L		See Note 1, below
471	Mono- and diglycerides of fatty acids	4 000 mg/L
472c	Citric and fatty acid esters of glycerol	7 500 mg/L		Only in a powdered product
		9 000 mg/L		Only in a liquid product
500	Sodium carbonates	2 000 mg/L
501	Potassium carbonates	2 000 mg/L
524	Sodium hydroxide	2 000 mg/L
525	Potassium hydroxide	2 000 mg/L
526	Calcium hydroxide	2 000 mg/L
551	Silicon dioxide (amorphous)	10 mg/L		May only be added as part of a nutrient preparation
1412	Distarch phosphate	5 000 mg/L		See Note 2, below.
1413	Phosphated distarch phosphate	5 000 mg/L		See Note 3, below.
1414	Acetylated distarch phosphate	5 000 mg/L		See Note 4, below.
1422	Acetylated distarch adipate	5 000 mg/L		See Note 5, below.
1440	Hydroxypropyl starch	5 000 mg/L		See Note 6, below.
1450	Starch sodium octenylsuccinate	100 mg/L	May only be added as part of a nutrient preparation
		1 000 mg/L	May only be added to polyunsaturated fatty acid preparations
Note 1. For additives 300, 301, 302, 304, 307b, 307c, 440—the additive may only be used in follow-on formula products. Note 2. Additive 1412 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1413, 1414 and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1413, 1414 and 1422. Note 3. Additive 1413 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1412, 1414 and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1412, 1414 and 1422. Note 4. Additive 1414 may only be used in: soy based infant formula product (other than follow-on formula) either singly or in combination with one or more of additives 1412, 1413, and 1440; and soy based follow-on formula either singly or in combination with one or more of additives 1412, 1413, and 1422. Note 5. Additive 1422 may only be used in soy based follow-on formula, either singly or in combination with one or more of additives 1412, 1413 and 1414. Note 6. Additive 1440 may only be used in soy based infant formula product (other than follow-on formula), either singly or in combination with one or more of additives 1412, 1413, and 1414.
13.1.1 Special medical purpose product for infants
170	Calcium carbonates	GMP
304	Ascorbyl palmitate	100 mg/L
333	Calcium citrates	GMP
338	Phosphoric acid	450 mg/L	For pH adjustment only
339	Sodium phosphates	450 mg/L
340	Potassium phosphates	450 mg/L
341	Calcium phosphates	450 mg/L
401	Sodium alginate	1 000 mg/L	Only in a product specifically formulated for both the dietary management of metabolic disorders of infants aged 4 months and above and general tube‑feeding of infants aged 4 months and above.
407	Carrageenan	1 000 mg/L	Only in a liquid product that contain hydrolysed proteins and/or amino acids
410	Locust bean (carob bean) gum	5 000 mg/L	Only in a product specifically formulated for reduction of gastro‑oesophageal reflux
412	Guar gum	10 000 mg/L	See Note 1, below.
415	Xanthan gum	1 200 mg/L	Only in a product that is based on hydrolysed protein, amino acids or peptides
440	Pectins	2 000 mg/L	Only in a liquid product that contain hydrolysed protein
		5 000 mg/L	Only in a product formulated for infants with gastro-intestinal disorders
471	Mono- and diglycerides of fatty acids	5 000 mg/L	Only in product formulated for diets devoid of proteins
472e	Diacyltartaric and fatty acid esters of glycerol	400 mg/L
1412	Distarch phosphate	25 000 mg/L	See Notes 2 and 7, below.
1413	Phosphated distarch phosphate	25 000 mg/L	See Notes 3 and 7, below.
1414	Acetylated distarch phosphate	25 000 mg/L	See Notes 4 and 7, below.
1422	Acetylated distarch adipate	25 000 mg/L	See Notes 5 and 7, below
1440	Hydroxypropyl starch	25 000 mg/L	Sees Note 6 and 7, below.
1450	Starch sodium octenylsuccinate	20 000 mg/L	See Note 7, below
Note 1. Additive 412 may only be used in a product that contains one or more of the following: hydrolysed proteins; peptides; amino acids. Note 2. Additive 1412 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1413, 1414 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1413, 1414 and 1422. Note 3. Additive 1413 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1414 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1414 and 1422. Note 4. Additive 1414 may only be used in: a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1413 and 1440; and a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1413 and 1422. Note 5. Additive 1422 may only be used in a product formulated for infants aged 6 to 12 months either singly or in combination with one or more of additives 1412, 1413 and 1414. Note 6. Additive 1440 may only be used in a product (other than a product formulated for infants aged 6 to 12 months) either singly or in combination with one or more of additives 1412, 1413, and 1414. Note 7. Additives 1412, 1413, 1414, 1422, 1440 and 1450 may only be used in a product that contains hydrolysed proteins, amino acids or both.

Schedule 19—Maximum levels of contaminants and natural toxicants

[22] The table to section S19—4 (Maximum levels of metal contaminants)

Insert:

Aluminium	Infant formula, follow-on formula and special medical purpose product for infants (other than special medical purpose product for infants formulated for pre-term infants)	0.5
	Soy-based infant formula products	1
	Special medical purpose product for infants formulated for pre-term infants	0.2

[23] The table to section S19—4 (table item dealing with "Lead", entry dealing with the food "infant formula products" and its associated maximum level)

Repeal the entry, substitute:

Infant formula products

0.01

Schedule 25—Permitted novel foods

[24] Subsection S25—2

Repeal

Dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)
Oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)	1. May only be added to infant formula products in accordance with Standard 2.9.1.
Oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)
Oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)

substitute:

Dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)	1. May be added to infant formula products in accordance with Standard 2.9.1.
Oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)	1. Only permitted for use in infant formula products in accordance with Standard 2.9.1
Oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)	1. May be added to infant formula products in accordance with Standard 2.9.1.
Oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)	1. May be added to infant formula products in accordance with Standard 2.9.1.

[25] Subsection S25—2 (table item dealing with “Isomalto-oligosaccharide”)

Repeal the table item, substitute:

Isomalto-oligosaccharide

1. Must not be added to:

food for infants; and
formulated supplementary food for young children.

[26] Subsection S25—2 (table item dealing with “Rapeseed protein isolate”, column headed “Conditions of use”, condition 2)

Repeal the condition, substitute:

2. Must not be added to food for infants.

[27] Subsection S25—2 (table item dealing with “Trehalose”)

Repeal the table item, substitute:

Trehalose

1. May be added to infant formula products only as a cryo-preservative for L(+) lactic acid producing microorganisms.