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Standard 2.9.5 Food Standards as made
This instrument inserts a new standard in the Australia New Zealand Food Standards Code.
Administered by: Health
Made 22 Jun 2012
Registered 27 Jun 2012
Tabled HR 28 Jun 2012
Tabled Senate 29 Jun 2012
Date of repeal 01 Mar 2016
Repealed by Australia New Zealand Food Standards Code - Standard 5.1.1 - Revocation and Transitional Provisions - 2014 revision

Description: FS_Logo_K

 

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.