Standard 2.9.3
Formulated Meal Replacements and Formulated Supplementary Foods
Purpose
This Standard provides compositional and labelling requirements for formulated meal replacements and formulated supplementary foods. In addition, this Standard sets out the compositional and labelling requirements for formulated supplementary foods for young children, aged one to three years.
Table of Provisions
Division 1 – Interpretation
1 Interpretation
Division 2 – Formulated meal replacements
2 Compositional requirements for formulated meal replacements
3 Labelling of formulated meal replacements
Division 3 – Formulated supplementary foods
4 Compositional requirements for formulated supplementary foods
5 Labelling of formulated supplementary foods
Division 4 – Formulated supplementary foods for young children
6 Compositional requirements for formulated supplementary foods for young children
7 Labelling of formulated supplementary foods for young children
Schedule Formulated meal replacements and formulated supplementary foods and formulated supplementary foods for young children
Division 1 – Interpretation
Clauses
1 Interpretation
In this Standard –
formulated meal replacement means a single food or pre-packaged selection of foods that is sold as a replacement for one or more of the daily meals but not as a total diet replacement.
formulated supplementary food means a food specifically designed as a supplement to a normal diet to address situations where intakes of energy and nutrients may not be adequate to meet an individual’s requirements.
formulated supplementary food for young children means a formulated supplementary food for children aged one to three years.
permitted form means the form of vitamin or mineral specified in column 2 of the Schedule to Standard 1.1.1 and in the case of formulated meal replacements, those listed in column 2 of the Schedule to Standard 2.9.4.
serving means a quantity of the food which constitutes one normal serving when prepared according to manufacturer’s directions or when the food requires no further preparation before consumption, and in the case of a formulated meal replacement is equivalent to one meal.
Editorial note:
Recommended Dietary Intake (RDI) and Estimated Safe and Adequate Daily Dietary Intake (ESADDI) are defined in Standard 1.1.1 for the purposes of this Standard.
Division 2 – Formulated meal replacements
2 Compositional requirements for formulated meal replacements
(1) Formulated meal replacements must contain in a serving no less than –
(a) 12 g protein; and
(b) 850 kJ; and
(c) 25% of the RDI of each of those vitamins and minerals listed in column 1 of Table 1 in the Schedule.
(2) A formulated meal replacement may have added to it the vitamins and minerals listed in –
(a) column 1 of Table 1 in the Schedule, provided the total of the naturally occurring and added quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 2 of Table 1; and
(b) column 1 of Table 2 in the Schedule, provided the total of the naturally occurring and added quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 2 of Table 2.
(3) Vitamins and minerals added to formulated meal replacements must be in the permitted form.
3 Labelling of formulated meal replacements
(1) Subject to subclause (2), the nutrition information panel on the label on a package of formulated meal replacement must include a declaration of the average quantities of the vitamins and minerals present in the food and –
(a) listed in column 1 of Table 1 to the Schedule; and
(b) listed in column 1 of Table 2 to the Schedule, and have been added to the food.
(2) A claim as to the presence in a formulated meal replacement of a vitamin or mineral listed in column 1 of Table 1 or Table 2 in the Schedule may be made on the label on a package of formulated meal replacement, provided that –
(a) no less than 10% of the RDI or ESADDI of that vitamin or mineral is present in a serving of the food; and
(b) where a vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving is no more than the quantity set out in column 3 of Table 1 or Table 2.
(2A) A claim, either express or implied, that a formulated meal replacement is a good source of a vitamin or mineral may be made if –
(a) the vitamin or mineral is listed in column 1 of Table 1 or Table 2 in the Schedule; and
(b) a serving of the food contains at least 25% of the RDI or ESADDI of that vitamin or mineral; and
(c) where the vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving is no more than the quantity set out in column 3 of Table 1 or 2.
(3) ‘Formulated meal replacement’ is a prescribed name.
(4) The label on a package of formulated meal replacement must include words to the effect that the product must not be used as a total diet replacement.
Division 3 – Formulated supplementary foods
4 Compositional requirements for formulated supplementary foods
(1) Formulated supplementary foods must contain in a serving no less than –
(a) 8 g protein; and
(b) 550 kJ; and
(c) 20% of the RDI of no less than one of those vitamins or minerals listed in column 1 of Table 3 in the Schedule, provided the total quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 4 of Table 3.
(2) The vitamins or minerals listed in column 1 of Table 3 in the Schedule may be added to a formulated supplementary food, provided the total of the naturally occurring and added quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 4 of Table 3.
(3) Vitamins and minerals added to formulated supplementary foods must be in the permitted form.
5 Labelling of formulated supplementary foods
(1) Subject to subclause (2), the nutrition information panel on the label on a package of formulated supplementary food must include a declaration of the average quantity of a vitamin or mineral present in the food where that vitamin or mineral is listed in column 1 of Table 3 to the Schedule and has been added to the food.
(1A) In this clause, claimable vitamin or mineral means a vitamin or mineral that is listed in –
(a) the Schedule to Standard 1.1.1; or
(b) Column 1 of Table 3 in the Schedule to this Standard.
(2) A claim as to the presence in a formulated supplementary food of a claimable vitamin or mineral may be made on the label on a package of formulated supplementary food provided that –
(a) no less than 10% of the RDI of the vitamin or mineral listed in column 1 of Table 3 is present in a serving of the food; and
(b) no less than 10% of the ESADDI of the vitamin or mineral is present in a serving of the food; and
(c) where a vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving of the food is no more than the quantity set out in column 5 of Table 3.
(2A) A claim, either express or implied, that a formulated supplementary food is a good source of a vitamin or mineral may be made if –
(a) the vitamin or mineral is a claimable vitamin or mineral; and
(b) a serving of the food contains at least 25% of the RDI or ESADDI of that vitamin or mineral; and
(c) where the vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving is no more than the quantity set out in column 5 of Table 3.
(3) The label on a package of formulated supplementary food must include a description of the role of the food as a supplement to a normal diet to address situations where intakes of energy and nutrients may not be adequate to meet an individual’s requirements.
(4) ‘Formulated supplementary food’ is a prescribed name.
Division 4 – Formulated supplementary foods for young children
6 Compositional requirements for formulated supplementary foods for young children
(1) Formulated supplementary foods for young children must contain in a serving no less than –
(a) 2.5 g protein; and
(b) 330 kJ; and
(c) 20% of the RDI of no less than one of those vitamins or minerals listed in column 1 of Table 3 in the Schedule, provided the total quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 2 of Table 3.
(2) The vitamins or minerals listed in column 1 of Table 3 in the Schedule may be added to a formulated supplementary food for young children, provided the total of the naturally occurring and added quantity of each vitamin or mineral in a serving is no more than the quantity, where specified, set out in relation to that vitamin or mineral in column 2 of Table 3.
(3) Vitamins and minerals added to formulated supplementary foods for young children must be in the permitted form.
(4) Formulated supplementary foods for young children may contain singularly or in combination, no more than 1.6 g of inulin-type fructans and galacto-oligosaccharides per serving.
(5) For subclause 6(4) the maximum permitted amount only applies when the substances are added. In that case the maximum permitted amount then applies to the sum of the naturally-occurring and the added substances.
6A Lutein
(1) Lutein from Tagetes erecta L. is a nutritive substance which may be added to a formulated supplementary food for young children, provided the total of the naturally occurring and added amounts of lutein is no more than 100 µg per serving.
(2) The label on a package of formulated supplementary food for young children must not include any words indicating, or any other indication, that the product contains lutein unless the total amount of lutein is no less than 30 µg per serving.
7 Labelling of formulated supplementary foods for young children
(1) Subject to subclause (2), the nutrition information panel on the label on a package of formulated supplementary food for young children must include a declaration of the average quantity of a vitamin or mineral present in the food where that vitamin or mineral is listed in column 1 of Table 3 to the Schedule and has been added to the food.
(1A) In this clause, claimable vitamin or mineral means a vitamin or mineral that is listed in –
(a) the Schedule to Standard 1.1.1; or
(b) Column 1 of Table 3 in the Schedule to this Standard.
(2) A claim as to the presence in a formulated supplementary food for young children of a claimable vitamin or mineral may be made on the label on a package of formulated supplementary food provided that –
(a) no less than 10% of the RDI of the vitamin or mineral listed in column 1 of Table 3 is present in a serving of the food; and
(b) no less than 10% of the ESADDI of the vitamin or mineral is present in a serving of the food; and
(c) where a vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving of the food is no more than the quantity set out in column 3 of Table 3.
(2A) A claim, either express or implied, that a formulated supplementary food for young children is a good source of a vitamin or mineral may be made if –
(a) the vitamin or mineral is a claimable vitamin or mineral; and
(b) a serving of the food contains at least 25% of the RDI or ESADDI of that vitamin or mineral; and
(c) where the vitamin or mineral has been added to the food, the claimed quantity of that vitamin or mineral in a serving is no more than the quantity set out in column 3 of Table 3.
(3) The label on a package of formulated supplementary food for young children must include a description of the role of the food as a supplement to a normal diet to address situations where intakes of energy and nutrients may not be adequate to meet an individual’s requirements.
(4) ‘Formulated supplementary food for young children’ is a prescribed name.
SCHEDULE
Table 1
Formulated meal replacements
| Column 1 | Column 2 | Column 3 |
| Vitamins and minerals | Maximum quantity per one-meal serving (proportion RDI) | Maximum claim per one-meal serving (proportion RDI) |
| Vitamin A | 300 µg (40%) | 300 µg (40%) |
| Thiamin | No quantity set | 0.55 mg (50%) |
| Riboflavin | No quantity set | 0.85 mg (50%) |
| Niacin | No quantity set | 5.0 mg (50%) |
| Folate | No quantity set | 100 µg (50%) |
| Vitamin B6 | No quantity set | 0.8 mg (50%) |
| Vitamin B12 | No quantity set | 1.0 µg (50%) |
| Vitamin C | No quantity set | 20 mg (50%) |
| Vitamin D | 5.0 µg (50%) | 5.0 µg (50%) |
| Vitamin E | No quantity set | 5.0 mg (50%) |
| Calcium | No quantity set | 400 mg (50%) |
| Iodine | 75 µg (50%) | 75 µg (50%) |
| Iron | No quantity set | 4.8 mg (40%) |
| Magnesium | No quantity set | 160 mg (50%) |
| Phosphorus | No quantity set | 500 mg (50%) |
| Zinc | No quantity set | 4.8 mg (40%) |
| | | |
Table 2
Formulated meal replacements
| Column 1 | Column 2 | Column 3 |
| Vitamins and minerals | Maximum quantity per one-meal serving (proportion ESADDI unless stated otherwise) | Maximum claim per one-meal serving (proportion ESADDI unless stated otherwise) |
| Biotin | No quantity set | 5 µg (17%) |
| Pantothenic acid | No quantity set | 0.8 mg (17%) |
| Vitamin K | No quantity set | 40 µg (50%) |
| Chromium: | | |
| inorganic | 34 µg (17%) | 34 µg (17%) |
| organic | 16 µg (8%) | no claim permitted |
| Copper: | | |
| inorganic | 0.50 mg (17%) | 0.50 mg (17%) |
| organic | 0.24 mg (8%) | no claim permitted |
| Manganese: | | |
| inorganic | 0.85 mg (17%) | 0.85 mg (17%) |
| organic | 0.4 mg (8%) | no claim permitted |
| Molybdenum: | | |
| inorganic | 42.5 µg (17%) | 42.5 µg (17%) |
| organic | 20 µg (8%) | no claim permitted |
| Selenium: | | |
| inorganic | 17.5 µg (25% RDI) | 17.5 µg (25% RDI) |
| organic | 9 µg (13% RDI) | 9 µg (13% RDI) |
Table 3
Formulated supplementary foods and
formulated supplementary foods for young children
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
| Vitamins and minerals | Maximum quantity per serving (young children) (proportion RDI) | Maximum claim per serving
(young children) (proportion RDI) | Maximum quantity per serving (adults) (proportion RDI) | Maximum claim per serving (adults) (proportion RDI) |
| Vitamin A | 135 µg (45%) | 105 µg (35%) | 340 µg (45%) | 265 µg (35%) |
| Thiamin | No quantity set | 0.25 mg (50%) | No quantity set | 0.55 mg (50%) |
| Riboflavin | No quantity set | 0.4 mg (50%) | No quantity set | 0.85 mg (50%) |
| Niacin | No quantity set | 2.5 mg (50%) | No quantity set | 5.0 mg (50%) |
| Folate | No quantity set | 50 µg (50%) | No quantity set | 100 µg (50%) |
| Vitamin B6 | No quantity set | 0.35 mg (50%) | No quantity set | 0.8 mg (50%) |
| Vitamin B12 | No quantity set | 0.5 µg (50%) | No quantity set | 1.0 µg (50%) |
| Vitamin C | No quantity set | 15 mg (50%) | No quantity set | 20 mg (50%) |
| Vitamin D | 2.5 µg (50%) | 2.5 µg (50%) | 5.0 µg (50%) | 5.0 µg (50%) |
| Vitamin E | No quantity set | 2.5 mg (50%) | No quantity set | 5.0 mg (50%) |
| Calcium | No quantity set | 350 mg (50%) | No quantity set | 400 mg (50%) |
| Iodine | 70 µg (100%) | 35 µg (50%) | 75 µg (50%) | 75 µg (50%) |
| Iron – except ferric sodium edetate for formulated supplementary foods for young children | No quantity set | 3.0 mg (50%) | No quantity set | 6.0 mg (50%) |
| Magnesium | No quantity set | 32 mg (40%) | No quantity set | 130 mg (40% ) |
| Phosphorus | No quantity set | 250 mg (50%) | No quantity set | 500 mg (50%) |
| Zinc | No quantity set | 1.1 mg (25%) | No quantity set | 3.0 mg (25%) |
Amendment History
The Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.
These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.
About this compilation
This is a compilation of Standard 2.9.3 as in force on 1 August 2013 (up to Amendment No. 142). It includes any commenced amendment affecting the compilation to that date.
Prepared by Food Standards Australia New Zealand on 1 August 2013.
Uncommenced amendments or provisions ceasing to have effect
To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislative Instruments including or omitting those amendments and provided in the Amendment History once the date is passed.
The following abbreviations may be used in the table below:
ad = added or inserted am = amended
exp = expired or ceased to have effect rep = repealed
rs = repealed and substituted
Standard 2.9.2 was published in the Commonwealth of Australia Gazette No. P 30 on 20 December 2000 as part of Amendment 60 (F2008B00660 – 3 October 2008) and has been amended as follows:
| Clause affected | A’ment No. | FRLI registration Gazette | Commencement (Cessation) | How affected | Description of amendment |
| Table of Provs | 64 | F2008B00810 23 Dec 2008 FSC6 13 Dec 2002 | 13 Dec 2002 | rs | Schedule title. |
| 2(2) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 2(2) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 3(2A) | 138 | F2013L00050 14 Jan 2013 FSC80 18 Jan 2013 | 18 Jan 2013 | ad | Amendments relating to Standard 1.2.7. |
| 3(2)(b) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 4(1)(c), 4(2) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 5(1A), 5(2A) | 138 | F2013L00050 14 Jan 2013 FSC80 18 Jan 2013 | 18 Jan 2013 | ad | Amendments relating to Standard 1.2.7. |
| 5(2)(c) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| Division 4 | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | rs | Division heading. |
| 6A | 108 | F2009L02066 28 May 2009 FSC50 28 May 2009 | 28 May 2009 | ad | Permission for lutein. |
| 6(1)(c), 6(2) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 6(4)-(5) | 105 | F2009L00076 15 Jan 2009 FSC47 15 Jan 2009 | 15 Jan 2009 | ad | New subclauses. |
| 6(4) | 142 | 30 July 2013 F2013L01465 FSC84 1 Aug 2013 | 1 Aug 2013 | rs | ‘inulin-derived substances’ replaced with ‘inulin-type fructans’. |
| 7(1A) | 138 | F2013L00050 14 Jan 2013 FSC80 18 Jan 2013 | 18 Jan 2013 | ad | Amendments relating to Standard 1.2.7. |
| 7(2)(c) | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | ‘does not exceed’ replaced with ‘is no more than’. |
| 7(2A) | 138 | F2013L00050 14 Jan 2013 FSC80 18 Jan 2013 | 18 Jan 2013 | ad | Amendments relating to Standard 1.2.7. |
| Sch | 62 | F2008B00807 19 Dec 2008 FSC4 17 Sept 2002 | 17 Sept 2002 | rs | Column 3 of Table 2. |
| Sch | 62 | F2008B00807 19 Dec 2008 FSC4 17 Sept 2002 | 17 Sept 2002 | am | Heading for Table 3. |
| Sch | 85 | F2006L00469 10 Feb 2006 FSC27 10 Feb 2006 | 10 Feb 2006 | rs | Reference to iodine in Column 2 of Table 3. |
| Sch | 101 | F2008L03058 14 Aug 2008 FSC43 14 Aug 2008 | 14 Aug 2008 | rs | To amend the entry for Iron in Column 1 of Table 3. |
| Sch | 103 | F2008L03741 9 Oct 2008 FSC45 9 Oct 2008 | 9 Oct 2008 | am | Heading of Column 3 of Table 1. |