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Purpose
This Standard regulates the sale, composition and labelling of foods specially formulated for the dietary management of individuals with certain diseases, disorders or medical conditions. Food regulated by this Standard is intended to be used under medical supervision.
Because of the specialised nature and purpose of these foods, this Standard includes a restriction on the premises at which, and the persons by whom, food for special medical purposes may be sold to consumers.
Infant formula products as defined in Standard 2.9.1 of the Code and products formulated and represented as being for the dietary management of obesity or overweight are excluded from Standard 2.9.5, even though they might meet the requirements of this Standard.
Editorial note:
In accordance with usual practice, this Standard must be read in the context of the whole Code. This Standard both incorporates and exempts existing Standards in the Code, and also applies additional requirements specifically for food for special medical purposes. Where existing requirements have been incorporated, these are replicated in the Standard rather than cross referenced to the original Standard, for accuracy and ease of use.
Table of Provisions
Division 1 – Preliminary
1 Definition of food for special medical purposes
2 Other definitions
3 Application of other Standards
4 Claims must not be therapeutic in nature
Division 2 – Sale of food for special medical purposes
5 Restriction on the persons by whom, and the premises at which, food for special medical purposes may be sold
Division 3 – Composition
6 Permitted forms of particular substances
7 Compositional requirements for food represented as being suitable for use as a sole source of nutrition
Division 4 – Labelling
Subdivision 1 – Outline of requirements
8 Labelling and related requirements
Subdivision 2 – General labelling requirements
9 Mandatory information
10 Mandatory statements
11 Mandatory declaration
12 Labelling of ingredients
13 Date marking of food
14 Lactose claims in relation to food for special medical purposes
15 Claims in relation to gluten content of food for special medical purposes
16 Legibility requirements
Subdivision 3 – Labelling requirements for inner packages
17 Labelling requirements for inner packages
18 Information required on transportation outers
Clauses
Division 1 – Preliminary
1 Definition of food for special medical purposes
(1) Subject to subclause (2), a food is a food for special medical purposes if the food is –
(a) specially formulated for the dietary management of individuals –
(i) by way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food; and
(ii) whose dietary management cannot be completely achieved without the use of the food; and
(b) intended to be used under medical supervision; and
(c) represented as being a food for special medical purposes or for the dietary management of a disease, disorder or medical condition.
(2) A food is not a food for special medical purposes if the food is –
(a) formulated and represented as being for the dietary management of obesity or overweight; or
(b) an infant formula product as defined in Standard 2.9.1.
Example:
An infant formula product specifically formulated to satisfy metabolic conditions (refer Subdivision 2 of Division 3 of Standard 2.9.1) is excluded from the definition of a food for special medical purposes, even if the infant formula product satisfies the requirements of paragraphs (1)(a),(b) and (c), and will not be regulated by Standard 2.9.5.
2 Other definitions
(1) In this Standard –
inner package, in relation to a food for special medical purposes, means an individual package of the food that –
(a) is contained and sold within another package that is labelled in accordance with Subdivision 2 of Division 4; and
(b) is 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.
responsible institution means a hospital, hospice, aged care facility, disability facility, prison, boarding school or similar institution that is responsible for the welfare of its patients or residents and provides food to them.
3 Application of other Standards
(1) The following do not apply to a food for special medical purposes –
(a) clause 9 of Standard 1.1.1;
(b) Standards 1.1A.2, 1.3.2 and 1.5.1;
(c) Standards 2.9.2, 2.9.3 and 2.9.4;
(d) Part 1.2 of this Code, subject to subparagraph 9(e) (iv), paragraph 12(a), clauses 13 and 16, and sub clauses 17(3), (4) and (5).
(2) Subclauses 6(3) and (4) of Standard 1.5.3 apply to a food for special medical purposes as if such food were subject to Standard 1.2.1.
A claim in relation to a food for special medical purposes must not –
(a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition; or
(b) compare the food with a good that is –
(i) represented in any way to be for therapeutic use; or
(ii) likely to be taken to be for therapeutic use, whether because of the way in which the good is presented or for any other reason.
Division 2 – Sale of food for special medical purposes
5 Restriction on the persons by whom, and the premises at which, food for special medical purposes may be sold
(1) A food for special medical purposes must not be sold to a consumer, other than from or by –
(a) a medical practitioner or dietitian; or
(b) a medical practice, pharmacy or responsible institution; or
(c) a majority seller of that food for special medical purposes.
(2) In this clause, medical practitioner means a person registered or licensed as a medical practitioner under legislation in Australia or New Zealand, as the case requires, for the registration or licensing of medical practitioners.
(3) In this clause, a person is a majority seller of a food for special medical purposes during any [24] month period if –
(a) during the period, the person sold that food for special medical purposes to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions; and
(b) the sales mentioned in paragraph (a) represent more than one half of the total quantity of that food for special medical purposes sold by the person during the period.
Division 3 – Composition
6 Permitted forms of particular substances
(1) All or any of the following substances may be added to a food for special medical purposes –
(a) a substance that is listed in Column 1 of Schedule 1 of this Standard if the substance is in one or more of the corresponding forms listed in Column 2 of that Schedule;
(b) a substance that is listed in Column 1 of Schedule 1 of Standard 2.9.1 if the substance is in one or more of the corresponding forms listed in Column 2 of that Schedule;
(c) any other substance regardless of its form, subject to the requirements of any Standard that applies to the substance or the food for special medical purposes.
(2) A provision in another Standard that limits the amount of a substance mentioned in paragraph (1)(a) or (b) that may be added to a food does not apply to a food for special medical purposes.
7 Compositional requirements for food represented as being suitable for use as a sole source of nutrition
(1) If a food for special medical purposes is represented as being suitable for use as a sole source of nutrition, the food must contain –
(a) not less than the minimum amount, as prescribed in Column 2 of Schedule 2, of each vitamin, mineral and electrolyte contained in Column 1 of that Schedule; and
(b) if applicable, not more than the maximum amount, as prescribed in Column 3 of Schedule 2, of each vitamin and mineral contained in Column 1 of that Schedule.
(2) However, the food is not required to comply with subclause (1) to the extent that –
(a) a variation from a maximum or minimum amount is required for a particular medical purpose; and
(b) the food is labelled in accordance with subclause 10(2).
Division 4 – Labelling
Subdivision 1 – Outline of requirements
8 Labelling and related requirements
(1) There must be a label on a package of food for special medical purposes.
(2) Subject to sub clauses (3) and (4), the label must comply with the requirements of Subdivision 2.
(3) The requirements of Subdivision 3 apply instead of Subdivision 2 if the package is an inner package.
(4) The requirements of Subdivision 4 apply instead of Subdivision 2 to transportation outer.
(5) To avoid doubt, this Division does not apply to a food for special medical purposes that is not in a package.
Subdivision 2 – General labelling requirements
9 Mandatory information
The label on a package of food for special medical purposes must include the following information –
(a) a name or a description of the food sufficient to indicate the true nature of the food;
(b) the lot identification of the food;
(c) directions for the use of the food or the storage of the food, or both, if the food is of such a nature to require directions for health or safety reasons;
(d) the minimum or average energy content expressed per given quantity of the food;
(e) the average quantity or minimum quantity, expressed per given quantity of the food, of –
(i) protein, fat and carbohydrate; and
(ii) any vitamin, mineral or electrolyte present in the food, if the vitamin, mineral or electrolyte has been added to the food; and
(iii) any substance present in the food, if that substance is listed under Column 1 of Schedule 1 and has been added to the food; and
(iv) subject to sub clauses 14(4) and 15(5) of this Standard, any other substance if a nutrition claim as defined in Standard 1.2.8 is made in relation to that substance.
10 Mandatory statements
(1) The label on a package of food for special medical purposes must include the following statements –
(a) a statement to the effect that the food must be used under medical supervision;
(b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the food;
(c) a statement indicating the medical purpose of the food, which may include a disease, disorder or medical condition for which the food has been formulated;
(d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c);
(e) if the food has been formulated for a specific age group—a statement to the effect that the food is intended for persons within the specified age group;
(f) a statement indicating whether or not the food is suitable for use as a sole source of nutrition;
(g) the statements required by subclause (2) if the food is represented as being suitable for use as a sole source of nutrition;
(h) the advisory statements required by subclause (3);
(i) the warning statement required by subclause (4).
(2) For paragraph (1)(g), the required statements are –
(a) a statement to the effect that the food is not for parenteral use; and
(b) if the food has been modified to vary from the compositional requirements in Schedule 2 such that the content of one or more nutrients falls short of the prescribed minimum, or exceeds the prescribed maximum (if applicable), a statement indicating –
(i) the nutrient or nutrients which have been modified; and
(ii) whether each modified nutrient has been increased, decreased, or eliminated from the food.
(3) For paragraph (1)(h), the required advisory statements are –
(a) if the food contains bee pollen as an ingredient as defined in Standard 1.2.4—a statement to the effect that the food contains bee pollen which can cause severe allergic reactions; and
(b) if the food contains aspartame or aspartame-acesulphame salt—a statement to the effect that the food contains phenylalanine; and
(c) if the food contains guarana or extracts of guarana—a statement to the effect that the food contains caffeine; and
(d) if the food contains propolis as an ingredient as defined in Standard 1.2.4—a statement to the effect that the food contains propolis which can cause severe allergic reactions; and
(e) a statement to the effect that excess consumption of the food may have a laxative effect if the food contains –
(ii) one or more of the substances listed in Table 2 to this paragraph, either singularly or in combination, at a level of or in excess of 25 g/100 g; or
(iii) one or more of the substances listed in Table 1, in combination with one or more of the substances listed in Table 2, at a level of or in excess of 10 g/100 g.
Table 1 to paragraph
|
Substance
|
|
Lactitol
|
|
Maltitol
|
|
Maltitol syrup
|
|
Mannitol
|
|
Xylitol
|
Table 2 to paragraph
|
Substance
|
|
Erythritol
|
|
Isomalt
|
|
Polydextrose
|
|
Sorbitol
|
(4) If a food for special medical purposes contains royal jelly as an ingredient as defined in Standard 1.2.4, the following warning statement is required –
“This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers”.
Editorial note:
The requirements of sub clauses 10(3) and (4) are based on relevant aspects of clauses 2, 3 and 5 of Standard 1.2.3.
(5) Despite paragraph (1)(g), the information mentioned in subparagraph (2)(b)(ii) is not required to be on the label if the information is provided in other documentation about the food for special medical purposes.
11 Mandatory declaration
(1) A declaration of the presence in a food for special medical purposes of any of the substances listed in the Table to this clause is required if the substance is present as –
(a) an ingredient; or
(b) an ingredient of a compound ingredient; or
(c) a food additive or component of a food additive; or
(d) a processing aid or component of a processing aid.
Table to subclause 11(1)
|
Added Sulphites in concentrations of 10 mg/kg or more
|
|
Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains
|
|
Crustacea and their products
|
|
Egg and egg products
|
|
Fish and fish products
|
|
Milk and milk products
|
|
Peanuts and peanut products
|
|
Sesame seeds and sesame seed products
|
|
Soybeans and soybean products
|
|
Tree nuts and tree nut products other than coconut from the fruit of the palm Cocos nucifera
|
(2) If a declaration in relation to a food for special medical purposes is required under subclause (1), the declaration must be included on the label on any package of the food.
Editorial note:
The requirement of clause 11 is based on clause 4 of Standard 1.2.3.
12 Labelling of ingredients
The label on a package of food for special medical purposes must comply with one of the following –
(a) Standard 1.2.4 of this Code;
(b) Article 6, Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs;
(c) 21 CFR § 101.4.
13 Date marking of food
(1) A food for special medical purposes must comply with Standard 1.2.5.
(2) However, if a label on a package of food for special medical purposes is required to include a use-by date under Standard 1.2.5, the words ‘Expiry Date’, or words to similar effect, may be used instead of the words ‘Use By’, and Standard 1.2.5 applies to the food for special medical purposes as if any reference to a use-by date in that Standard were a reference to the ‘Expiry Date’, or the words to similar effect so used.
14 Lactose claims in relation to food for special medical purposes
(1) A claim to the effect that a food for special medical purposes is lactose free may be made if the food contains no detectable lactose.
(2) A claim to the effect that a food for special medical purposes is low lactose may be made if the food contains not more than 0.3 g of lactose per 100 g of the food.
(3) A claim to the effect that a food for special medical purposes is lactose reduced must be accompanied by a declaration of the proportion by which the lactose content of the food has been reduced.
(4) If a claim is made in relation to the lactose content of a food for special medical purposes, the label on the package of food must include the average quantity of the lactose and galactose in the food, expressed per given quantity of the food.
Editorial note:
The requirement of clause 14 is based on clause 15 of Standard 1.2.8.
15 Claims in relation to gluten content of food for special medical purposes
(1) A claim in relation to the gluten content of a food for special medical purposes is prohibited unless expressly permitted by this clause.
(2) A claim to the effect that a food for special medical purposes is gluten free may be made if the food contains –
(a) no detectable gluten; and
(b) no oats or oat products; and
(c) no cereals containing gluten that have been malted, or products of such cereals.
(3) A claim to the effect that a food for special medical purposes has a low gluten content may be made if the food contains no more than 20 mg gluten per 100 g of the food.
(4) A claim to the effect that a food for special medical purposes contains gluten or is high in gluten may be made.
(5) If a claim is made in relation to the gluten content of a food for special medical purposes, the label on the package of food must include the average quantity of the gluten in the food, expressed per given quantity of the food.
Editorial note:
The requirement of clause 15 is based on clause 16 of Standard 1.2.8.
16 Legibility requirements
The label on a package of food for special medical purposes must comply with Standard 1.2.9.
Subdivision 3 – Labelling requirements for inner packages
17 Labelling requirements for inner packages
(1) There must be a label on an inner package of food for special medical purposes.
(2) The label must include –
(a) a name or a description of the food sufficient to indicate the true nature of the food; and
(b) the lot identification of the food; and
(c) a declaration of the presence in the food of any of the substances listed in the Table to this paragraph if the substance is present as –
(i) an ingredient; or
(ii) an ingredient of a compound ingredient; or
(iii) a food additive or component of a food additive; or
(iv) a processing aid or component of a processing aid.
Table to paragraph
|
Added Sulphites in concentrations of 10 mg/kg or more
|
|
Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains
|
|
Crustacea and their products
|
|
Egg and egg products
|
|
Fish and fish products
|
|
Milk and milk products
|
|
Peanuts and peanut products
|
|
Sesame seeds and sesame seed products
|
|
Soybeans and soybean products
|
|
Tree nuts and tree nut products other than coconut from the fruit of the palm Cocos nucifera
|
(3) A food for special medical purposes contained in an inner package must comply with Standard 1.2.5, other than clause 6 of that Standard.
(5) The label on an inner package of food for special medical purposes must comply with Standard 1.2.9.
(6) To avoid doubt, this clause continues to apply to the label on an inner package of food for special medical purposes even if a responsible institution subsequently supplies the inner package to a patient or resident of the responsible institution.
Editorial note:
The requirement of paragraph 17(2)(c) is based on the requirements of clause 4 of Standard 1.2.3.
Subdivision 4 – Information requirements for transportation outers
18 Information required on transportation outers
(1) If packages of food for special medical purposes are in a transportation outer, then there must be a label on the transportation outer that includes –
(a) a name or a description of the food sufficient to indicate the true nature of the food; and
(b) the lot identification of the food; and
(c) the name and business address in Australia or New Zealand of the supplier of the food, unless that information is provided in documentation accompanying the food for special medical purposes.
(2) However, a label on a transportation outer is not required if the information mentioned in paragraphs (1)(a), (b) and (c) is clearly discernible through the transportation outer on the labels on the packages within the transportation outer.
SCHEDULE 1
Permitted forms of particular substances
|
Column 1
|
Column 2
|
|
Substances
|
Permitted Form
|
|
Vitamins
|
|
|
Niacin
|
Nicotinic acid
|
|
Vitamin B6
|
Pyridoxine dipalmitate
|
|
Folate
|
Calcium L-methylfolate
|
|
Vitamin E
|
D-alpha-tocopherol
|
|
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS)
|
|
|
Pantothenic acid
|
Sodium pantothenate
|
|
D-panthenol
|
|
|
DL-panthenol
|
|
|
Minerals and Electrolytes
|
|
|
Boron
|
Sodium borate
|
|
Boric acid
|
|
|
Calcium
|
Calcium bisglycinate
|
|
Calcium citrate malate
|
|
|
Calcium malate
|
|
|
Calcium L-pidolate
|
|
|
Chloride
|
Choline chloride
|
|
Sodium chloride, iodised
|
|
|
Hydrochloric acid
|
|
|
Chromium
|
Chromium chloride
|
|
Chromium picolinate
|
|
|
Chromium potassium sulphate
|
|
|
Copper
|
Copper-lysine complex
|
|
Cupric carbonate
|
|
|
Fluoride
|
Potassium fluoride
|
|
Sodium fluoride
|
|
|
Iodine
|
Sodium iodate
|
|
Iron
|
Carbonyl iron
|
|
Electrolytic iron
|
|
|
Ferric citrate
|
|
|
Ferric gluconate
|
|
|
Ferric orthophosphate
|
|
|
Ferric pyrophosphate, sodium
|
|
|
Ferric saccharate
|
|
|
Ferric sodium diphosphate
|
|
|
Ferrous bisglycinate
|
|
|
Ferrous carbonate
|
|
|
Ferrous carbonate, stabilised
|
|
|
Ferrous L-pidolate
|
|
|
Iron, reduced (ferrum reductum)
|
|
|
Magnesium
|
Magnesium acetate
|
|
Magnesium L-aspartate
|
|
|
Magnesium bisglycinate
|
|
|
Magnesium citrate
|
|
|
Magnesium glycerophosphate
|
|
|
Magnesium hydroxide
|
|
|
Magnesium hydroxide carbonate
|
|
|
Magnesium lactate
|
|
|
Magnesium phosphate, monobasic
|
|
|
Magnesium L-pidolate
|
|
|
|
|
|
Magnesium potassium citrate
|
|
|
|
|
SCHEDULE 1 (continued)
Permitted forms of particular substances
|
Column 1
|
Column 2
|
|
Substances
|
Permitted Form
|
|
Manganese
|
Manganese glycerophosphate
|
|
Molybdenum
|
Ammonium molybdate
|
|
Potassium
|
Potassium glycerophosphate
|
|
Potassium lactate
|
|
|
Potassium L-pidolate
|
|
|
Selenium
|
Selenium enriched yeast
|
|
Sodium hydrogen selenite
|
|
|
Sodium selenate
|
|
|
Zinc
|
Zinc bisglycinate
|
|
Zinc carbonate
|
|
|
Zinc citrate
|
|
|
Zinc lactate
|
|
|
Other substances
|
|
|
Amino acids
|
Sodium, potassium, calcium, magnesium salts of single amino acids listed in this Schedule
|
|
Hydrochlorides of single amino acids listed in this Schedule
|
|
|
L-alanine
|
|
|
L-arginine
|
|
|
L-asparagine
|
|
|
L-aspartic acid
|
|
|
L-citrulline
|
|
|
L-cysteine
|
|
|
L-cystine
|
|
|
L-glutamic acid
|
|
|
L-glutamine
|
|
|
Glycine
|
|
|
L-histidine
|
|
|
L-isoleucine
|
|
|
L-leucine
|
|
|
L-lysine
|
|
|
L-lysine acetate
|
|
|
L-methionine
|
|
|
L-ornithine
|
|
|
L-phenylalanine
|
|
|
L-proline
|
|
|
L-serine
|
|
|
L-threonine
|
|
|
L-tyrosine
|
|
|
L-tryptophan
|
|
|
L-valine
|
|
|
L-arginine-L-aspartate
|
|
|
L-lysine-L-aspartate
|
|
|
L-lysine-L-glutamate
|
|
|
N-acetyl-L-methionine
|
|
|
L-carnitine
|
|
|
Carnitine
|
L-carnitine hydrochloride
|
|
L-carnitine L-tartrate
|
|
|
Choline
|
|
|
Choline
|
Choline bitartrate
|
|
Choline chloride
|
|
|
Choline citrate
|
|
|
Choline hydrogen tartrate
|
|
|
|
|
|
Inositol
|
|
|
|
|
SCHEDULE 1 (continued)
Permitted forms of particular substances
|
Column 1
|
Column 2
|
|
Substances
|
Permitted Form
|
|
Inositol
|
Adenosine 5′-monophosphate
|
|
Nucleotides
|
Adenosine 5′-monophosphate sodium salt
|
|
Cytidine 5′-monophosphate
|
|
|
Cytidine 5′-monophosphate sodium salt
|
|
|
Guanosine 5′-monophosphate
|
|
|
Guanosine 5′-monophosphate sodium salt
|
|
|
Inosine 5′-monophosphate
|
|
|
Inosine 5′-monophosphate sodium salt
|
|
|
Uridine 5′-monophosphate
|
|
|
Uridine 5′-monophosphate sodium salt
|
|
|
Taurine
|
Taurine
|
SCHEDULE 2
Minimum and maximum content of vitamins, minerals and electrolytes in food for special medical purposes represented as being suitable for use as a sole source of nutrition
|
Column 1
|
Column 2
|
Column 3
|
|
Nutrient
|
Minimum Amount per MJ
|
Maximum Amount per MJ
|
|
Vitamins
|
||
|
Vitamin A
|
84 µg retinol equivalents1
|
430 µg retinol equivalents1
|
|
Thiamin
|
0.15 mg
|
No maximum set
|
|
Riboflavin
|
0.2 mg
|
No maximum set
|
|
Niacin
|
2.2 mg niacin equivalents2
|
No maximum set
|
|
Vitamin B6
|
0.2 mg
|
1.2 mg
|
|
Folate
|
25 µg
|
No maximum set
|
|
Vitamin B12
|
0.17 µg
|
No maximum set
|
|
Vitamin C
|
5.4 mg
|
No maximum set
|
|
Vitamin D
|
1.2 µg
|
6.5 µg or 7.5 µg3
|
|
Vitamin E
|
1 mg alpha-tocopherol equivalents4
|
No maximum set
|
|
Biotin
|
1.8 µg
|
No maximum set
|
|
Pantothenic Acid
|
0.35 mg
|
No maximum set
|
|
Vitamin K
|
8.5 µg
|
No maximum set
|
|
Minerals
|
||
|
Calcium
|
84 mg or 120 mg3
|
420 mg or 600 mg3
|
|
Magnesium
|
18 mg
|
No maximum set
|
|
Iron
|
1.2 mg
|
No maximum set
|
|
Phosphorus
|
72 mg
|
No maximum set
|
|
Zinc
|
1.2 mg
|
3.6 mg
|
|
Manganese
|
0.12 mg
|
1.2 mg
|
|
Copper
|
0.15 mg
|
1.25 mg
|
|
Iodine
|
15.5 µg
|
84 µg
|
|
Chromium
|
3 µg
|
No maximum set
|
|
Molybdenum
|
7 µg
|
No maximum set
|
|
Selenium
|
6 µg
|
25 µg
|
|
Electrolytes
|
||
|
Sodium
|
72 mg
|
No maximum set
|
|
Potassium
|
190 mg
|
No maximum set
|
|
Chloride
|
72 mg
|
No maximum set
|
1, 2, and 4 These numbers refer to the corresponding numbers in the footnotes in Schedule 1 in Standard 1.1.1.
3 The higher amount applies only to products intended for children aged one to ten years.
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2.9.5.pdf
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