Standard 2.9.5 – Food for Special Medical Purposes
The Board of Food Standards Australia New Zealand gives notice of the making of this Standard under section 92 of the Food Standards Australia New Zealand Act 1991. The Standard commences on 28 June 2014.
Dated 22 June 2012
Standards Management Officer
Delegate of the Board of Food Standards Australia New Zealand
STANDARD 2.9.5
FOOD FOR SPECIAL MEDICAL PURPOSES
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
Subdivision 4 – Information requirements for transportation outers
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.
(2) In this Standard, a reference to a package does not include a plate, cup, tray or other food container in or on which food for special medical purposes is served by a responsible institution to a patient or resident of the responsible institution, whether the plate, cup, tray or food container is uncovered, or is covered in whole or in part.
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.
4 Claims must not be therapeutic in nature
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 –
(i) one or more of the substances listed in Table 1 to this paragraph, either singularly or in combination, at a level of or in excess of 10 g/100 g; or
(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.
(4) However, if a label on an inner 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.
(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.
