{"id":"F2012L01347","name":"Australia New Zealand Food Standards Code - Standard 2.9.5 - Food for Special Medical Purposes","slug":"f2012l01347","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":314316,"registerId":"commonwealth-F2012L01347-current","compilationNumber":null,"startDate":"2026-04-08","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Division 1","sectionType":"division","heading":"Preliminary","content":"### Division 1 – Preliminary\n\n1 Definition of food for special medical purposes\n\n(1) Subject to subclause (2), a food is a food for special medical purposes if the food is –\n\n (a) specially formulated for the dietary management of individuals –\n\n (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\n (ii) whose dietary management cannot be completely achieved without the use of the food; and\n\n (b) intended to be used under medical supervision; and\n (c) represented as being a food for special medical purposes or for the dietary management of a disease, disorder or medical condition.\n\n(2) A food is not a food for special medical purposes if the food is –\n\n (a) formulated and represented as being for the dietary management of obesity or overweight; or\n (b) an infant formula product as defined in Standard 2.9.1.\n\n> Note: Example:\n\n> Note: 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.\n\n2 Other definitions\n\n(1) In this Standard –\n\n> inner package, in relation to a food for special medical purposes, means an individual package of the food that –\n\n (a) is contained and sold within another package that is labelled in accordance with Subdivision 2 of Division 4; and\n (b) is not designed for individual sale, other than a sale by a responsible institution to a patient or resident of the responsible institution.\n\n> Note: Example:\n\n> Note: 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.\n\n> 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.\n\n \n\n(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.\n\n2A Deemed compliance with Standard for certain periods\n\n(1) This clause applies to a food for special medical purposes that does not comply with this Standard.\n\n(2) If the food for special medical purposes is present in Australia or New Zealand on the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts on that date of commencement and ends on 28 June 2014.\n\n(3) If the food for special medical purposes is imported into Australia or New Zealand on a date after the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts immediately prior to importation and ends on 28 June 2014.\n\n(4) If the food for special medical purposes is produced in Australia or New Zealand on a date after the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts on the date the food for special medical purposes was produced and ends on 28 June 2014.\n\n3 Application of other Standards\n\n(1) The following do not apply to a food for special medical purposes –\n\n (a) clause 9 of Standard 1.1.1;\n (b) Standards 1.3.2 and 1.5.1;\n (c) Standards 2.9.2, 2.9.3 and 2.9.4;\n (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).\n\n(2) Subclause 6(3) of Standard 1.5.3 applies to a food for special medical purposes as if such food were subject to Standard 1.2.1.\n\n(3) Subclause 1(2) of Standard 1.1.1 does not apply in relation to a food for special medical purposes that did not comply with Standard 2.9.5 on the date that Standard 2.9.5 commenced.\n\n4 Claims must not be therapeutic in nature\n\nA claim in relation to a food for special medical purposes must not –\n\n (a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition; or\n (b) compare the food with a good that is –\n\n (i) represented in any way to be for therapeutic use; or\n (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.","sortOrder":0},{"sectionNumber":"Division 2","sectionType":"division","heading":"Sale of food for special medical purposes","content":"### Division 2 – Sale of food for special medical purposes\n\n5 Restriction on the persons by whom, and the premises at which, food for special medical purposes may be sold\n\n(1) A food for special medical purposes must not be sold to a consumer, other than from or by – \n\n (a) a medical practitioner or dietitian; or\n (b) a medical practice, pharmacy or responsible institution; or\n (c) a majority seller of that food for special medical purposes.\n\n(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.\n\n(3) In this clause, a person is a majority seller of a food for special medical purposes during any \\[24\\] month period if –\n\n (a) during the period, the person sold that food for special medical purposes to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions; and\n (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.","sortOrder":1},{"sectionNumber":"Division 3","sectionType":"division","heading":"Composition","content":"### Division 3 – Composition\n\n6 Permitted forms of particular substances\n\n(1) All or any of the following substances may be added to a food for special medical purposes –\n\n (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;\n (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;\n (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.\n\n(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.\n\n7 Compositional requirements for food represented as being suitable for use as a sole source of nutrition\n\n(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 –\n\n (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\n (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.\n\n(2) However, the food is not required to comply with subclause (1) to the extent that –\n\n (a) a variation from a maximum or minimum amount is required for a particular medical purpose; and\n (b) the food is labelled in accordance with subclause 10(2).","sortOrder":2},{"sectionNumber":"Division 4","sectionType":"division","heading":"Labelling","content":"STANDARD 2.9.5\n\nFOOD FOR SPECIAL MEDICAL PURPOSES\n\nPurpose\n\nThis 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.\n\nBecause 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.\n\nInfant 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.\n\n> Note: Editorial note:\n\n> 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.\n\nTable of Provisions\n\nDivision 1 – Preliminary\n\n1 Definition of food for special medical purposes\n\n2 Other definitions\n\n2A Deemed compliance with Standard for certain periods\n\n3 Application of other Standards\n\n4 Claims must not be therapeutic in nature\n\nDivision 2 – Sale of food for special medical purposes\n\n5 Restriction on the persons by whom, and the premises at which, food for special medical purposes may be sold\n\nDivision 3 – Composition\n\n6 Permitted forms of particular substances\n\n7 Compositional requirements for food represented as being suitable for use as a sole source of nutrition\n\nDivision 4 – Labelling\n\nSubdivision 1 – Outline of requirements\n\n8 Labelling and related requirements\n\nSubdivision 2 – General labelling requirements\n\n9 Mandatory information\n\n10 Mandatory statements\n\n11 Mandatory declaration\n\n12 Labelling of ingredients\n\n13 Date marking of food\n\n14 Lactose claims in relation to food for special medical purposes\n\n15 Claims in relation to gluten content of food for special medical purposes\n\n16 Legibility requirements\n\nSubdivision 3 – Labelling requirements for inner packages\n\n17 Labelling requirements for inner packages \n\nSubdivision 4 – Information requirements for transportation outers\n\n18 Information required on transportation outers\n\nClauses\n\n### Division 1 – Preliminary\n\n1 Definition of food for special medical purposes\n\n(1) Subject to subclause (2), a food is a food for special medical purposes if the food is –\n\n (a) specially formulated for the dietary management of individuals –\n\n (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\n (ii) whose dietary management cannot be completely achieved without the use of the food; and\n\n (b) intended to be used under medical supervision; and\n (c) represented as being a food for special medical purposes or for the dietary management of a disease, disorder or medical condition.\n\n(2) A food is not a food for special medical purposes if the food is –\n\n (a) formulated and represented as being for the dietary management of obesity or overweight; or\n (b) an infant formula product as defined in Standard 2.9.1.\n\n> Note: Example:\n\n> Note: 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.\n\n2 Other definitions\n\n(1) In this Standard –\n\n> inner package, in relation to a food for special medical purposes, means an individual package of the food that –\n\n (a) is contained and sold within another package that is labelled in accordance with Subdivision 2 of Division 4; and\n (b) is not designed for individual sale, other than a sale by a responsible institution to a patient or resident of the responsible institution.\n\n> Note: Example:\n\n> Note: 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.\n\n> 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.\n\n \n\n(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.\n\n2A Deemed compliance with Standard for certain periods\n\n(1) This clause applies to a food for special medical purposes that does not comply with this Standard.\n\n(2) If the food for special medical purposes is present in Australia or New Zealand on the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts on that date of commencement and ends on 28 June 2014.\n\n(3) If the food for special medical purposes is imported into Australia or New Zealand on a date after the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts immediately prior to importation and ends on 28 June 2014.\n\n(4) If the food for special medical purposes is produced in Australia or New Zealand on a date after the date of commencement of this Standard, the food for special medical purposes is taken to comply with this Standard during the period that starts on the date the food for special medical purposes was produced and ends on 28 June 2014.\n\n3 Application of other Standards\n\n(1) The following do not apply to a food for special medical purposes –\n\n (a) clause 9 of Standard 1.1.1;\n (b) Standards 1.3.2 and 1.5.1;\n (c) Standards 2.9.2, 2.9.3 and 2.9.4;\n (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).\n\n(2) Subclause 6(3) of Standard 1.5.3 applies to a food for special medical purposes as if such food were subject to Standard 1.2.1.\n\n(3) Subclause 1(2) of Standard 1.1.1 does not apply in relation to a food for special medical purposes that did not comply with Standard 2.9.5 on the date that Standard 2.9.5 commenced.\n\n4 Claims must not be therapeutic in nature\n\nA claim in relation to a food for special medical purposes must not –\n\n (a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition; or\n (b) compare the food with a good that is –\n\n (i) represented in any way to be for therapeutic use; or\n (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.\n\n### Division 2 – Sale of food for special medical purposes\n\n5 Restriction on the persons by whom, and the premises at which, food for special medical purposes may be sold\n\n(1) A food for special medical purposes must not be sold to a consumer, other than from or by – \n\n (a) a medical practitioner or dietitian; or\n (b) a medical practice, pharmacy or responsible institution; or\n (c) a majority seller of that food for special medical purposes.\n\n(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.\n\n(3) In this clause, a person is a majority seller of a food for special medical purposes during any \\[24\\] month period if –\n\n (a) during the period, the person sold that food for special medical purposes to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions; and\n (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.\n\n### Division 3 – Composition\n\n6 Permitted forms of particular substances\n\n(1) All or any of the following substances may be added to a food for special medical purposes –\n\n (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;\n (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;\n (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.\n\n(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.\n\n7 Compositional requirements for food represented as being suitable for use as a sole source of nutrition\n\n(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 –\n\n (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\n (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.\n\n(2) However, the food is not required to comply with subclause (1) to the extent that –\n\n (a) a variation from a maximum or minimum amount is required for a particular medical purpose; and\n (b) the food is labelled in accordance with subclause 10(2).\n\n### Division 4 – Labelling\n\n### Subdivision 1 – Outline of requirements\n\n8 Labelling and related requirements\n\n(1) There must be a label on a package of food for special medical purposes.\n\n(2) Subject to sub clauses (3) and (4), the label must comply with the requirements of Subdivision 2.\n\n(3) The requirements of Subdivision 3 apply instead of Subdivision 2 if the package is an inner package.\n\n(4) The requirements of Subdivision 4 apply instead of Subdivision 2 to transportation outer.\n\n(5) To avoid doubt, this Division does not apply to a food for special medical purposes that is not in a package.\n\n### Subdivision 2 – General labelling requirements\n\n9 Mandatory information\n\nThe label on a package of food for special medical purposes must include the following information –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food;\n (b) the lot identification of the food;\n (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;\n (d) the minimum or average energy content expressed per given quantity of the food;\n (e) the average quantity or minimum quantity, expressed per given quantity of the food, of –\n\n (i) protein, fat and carbohydrate; and\n (ii) any vitamin, mineral or electrolyte present in the food, if the vitamin, mineral or electrolyte has been added to the food; and\n (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\n (iv) subject to subclauses 14(4) and 15(5) of this Standard, any other substance if a nutrition content claim as defined in Standard 1.2.7 is made in relation to that substance.\n\n10 Mandatory statements\n\n(1) The label on a package of food for special medical purposes must include the following statements –\n\n (a) a statement to the effect that the food must be used under medical supervision;\n (b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the food;\n (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;\n (d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c);\n (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;\n (f) a statement indicating whether or not the food is suitable for use as a sole source of nutrition;\n (g) the statements required by subclause (2) if the food is represented as being suitable for use as a sole source of nutrition;\n (h) the advisory statements required by subclause (3);\n (i) the warning statement required by subclause (4).\n\n(2) For paragraph (1)(g), the required statements are –\n\n (a) a statement to the effect that the food is not for parenteral use; and\n (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 –\n\n (i) the nutrient or nutrients which have been modified; and\n (ii) whether each modified nutrient has been increased, decreased, or eliminated from the food.\n\n(3) For paragraph (1)(h), the required advisory statements are –\n\n (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\n (b) if the food contains aspartame or aspartame-acesulphame salt—a statement to the effect that the food contains phenylalanine; and\n (c) if the food contains guarana or extracts of guarana—a statement to the effect that the food contains caffeine; and\n (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\n (e) a statement to the effect that excess consumption of the food may have a laxative effect if the food contains –\n\n (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\n (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\n (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.\n\nTable 1 to paragraph\n\n| Substance |\n| -------------- |\n| Lactitol |\n| Maltitol |\n| Maltitol syrup |\n| Mannitol |\n| Xylitol |\n\nTable 2 to paragraph\n\n| Substance |\n| ------------ |\n| Erythritol |\n| Isomalt |\n| Polydextrose |\n| Sorbitol |\n\n(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 –\n\n “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”.\n\n> Note: Editorial note:\n\n> 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.\n\n(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.\n\n11 Mandatory declaration\n\n(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 –\n\n (a) an ingredient; or\n (b) an ingredient of a compound ingredient; or\n (c) a food additive or component of a food additive; or\n (d) a processing aid or component of a processing aid.\n\nTable to subclause 11(1)\n\n| Added Sulphites in concentrations of 10 mg/kg or more |\n| --------------------------------------------------------------------------------------------------------------------- |\n| Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains |\n| Crustacea and their products |\n| Egg and egg products |\n| Fish and fish products |\n| Milk and milk products |\n| Peanuts and peanut products |\n\n(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.\n\n> Note: Editorial note:\n\n> Note: The requirement of clause 11 is based on clause 4 of Standard 1.2.3.\n\n12 Labelling of ingredients\n\nThe label on a package of food for special medical purposes must comply with one of the following –\n\n (a) Standard 1.2.4 of this Code;\n (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;\n (c) 21 CFR § 101.4.\n\n13 Date marking of food\n\n(1) A food for special medical purposes must comply with Standard 1.2.5.\n\n(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.\n\n14 Lactose claims in relation to food for special medical purposes\n\n(1) A claim in relation to the lactose content of a food for special medical purposes is prohibited unless expressly permitted by this clause. \n\n(2) 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.\n\n(3) 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 2 g of lactose per 100 g of the food.\n\n(4) If a claim in relation to the lactose content of a food for special medical purposes is made 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.\n\n> Note: Editorial note:\n\n> Note: The requirement of clause 14 is based on clause 15 of Standard 1.2.8.\n\n15 Claims in relation to gluten content of food for special medical purposes\n\n(1) A claim in relation to the gluten content of a food for special medical purposes is prohibited unless expressly permitted by this clause.\n\n(2) A claim to the effect that a food for special medical purposes is gluten free may be made if the food contains –\n\n (a) no detectable gluten; and\n (b) no oats or oat products; and\n (c) no cereals containing gluten that have been malted, or products of such cereals.\n\n(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.\n\n(4) A claim to the effect that a food for special medical purposes contains gluten or is high in gluten may be made.\n\n(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.\n\n16 Legibility requirements\n\nThe label on a package of food for special medical purposes must comply with Standard 1.2.9.\n\n### Subdivision 3 – Labelling requirements for inner packages\n\n17 Labelling requirements for inner packages\n\n(1) There must be a label on an inner package of food for special medical purposes.\n\n(2) The label must include –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food; and\n (b) the lot identification of the food; and\n (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 –\n\n (i) an ingredient; or\n (ii) an ingredient of a compound ingredient; or\n (iii) a food additive or component of a food additive; or\n (iv) a processing aid or component of a processing aid.\n\n \n\nTable to paragraph\n\n| Added Sulphites in concentrations of 10 mg/kg or more |\n| --------------------------------------------------------------------------------------------------------------------- |\n| Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains |\n| Crustacea and their products |\n| Egg and egg products |\n| Fish and fish products |\n| Milk and milk products |\n| Peanuts and peanut products |\n| Sesame seeds and sesame seed products |\n| Soybeans and soybean products |\n| Tree nuts and tree nut products other than coconut from the fruit of the palm Cocos nucifera |\n\n(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.\n\n(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.\n\n(5) The label on an inner package of food for special medical purposes must comply with Standard 1.2.9.\n\n(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.\n\n> Note: Editorial note:\n\n> Note: The requirement of paragraph 17(2)(c) is based on the requirements of clause 4 of Standard 1.2.3.\n\n### Subdivision 4 – Information requirements for transportation outers\n\n18 Information required on transportation outers\n\n(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 –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food; and\n (b) the lot identification of the food; and\n (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.\n\n(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.\n\n \n\n## SCHEDULE 1\n\nPermitted forms of particular substances\n\n```html\n

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

\n```\n\n## SCHEDULE 1 (continued)\n\nPermitted forms of particular substances\n\n```html\n

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

Carnitine

L-carnitine

L-carnitine hydrochloride

L-carnitine L-tartrate

Choline

Choline

Choline bitartrate

Choline chloride

Choline citrate

Choline hydrogen tartrate

Inositol

Inositol

\n```\n\n## SCHEDULE 1 (continued)\n\nPermitted forms of particular substances\n\n```html\n

Column 1

Column 2

Substances

Permitted Form

Nucleotides

Adenosine 5′-monophosphate

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

Taurine

Taurine

\n```\n\n## SCHEDULE 2\n\nMinimum 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\n\n```html\n

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

\n```\n\n1, 2, and 4 These numbers refer to the corresponding numbers in the footnotes in Schedule 1 in Standard 1.1.1.\n\n3 The higher amount applies only to products intended for children aged one to ten years.\n\n \n\n### Amendment History\n\nThe Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.\n\nThese 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.\n\nAbout this compilation\n\nThis is a compilation of Standard 2.9.5 as in force on 18 January 2016 (up to Amendment No. 150). It includes any commenced amendment affecting the compilation to that date.\n\nPrepared by Food Standards Australia New Zealand on 18 January 2016.\n\nUncommenced amendments or provisions ceasing to have effect\n\nTo 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.\n\nThe following abbreviations may be used in the table below:\n\nad = added or inserted am = amended\n\nexp = expired or ceased to have effect rep = repealed\n\nrs = repealed and substituted\n\nStandard 2.9.5 was published in the Food Standards Gazette No. FSC 74 on 28 June 2012 as part of Amendment No. 132 (F2012L01347 – 27 June 2012) and has been amended as follows:\n\n| Clause affected | A’ment No. | FRLI registrationGazette | Commencement(Cessation) | How affected | Description of amendment |\n| --------------- | ---------- | --------------------------------------------------------------------- | ----------------------- | ------------ | ------------------------------------------------------------------------------------------------------------------------- |\n| C’ment | 139 | F2012L0134727 June 2012as am byF2013L0025321 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Commencement date for the Standard brought forward from 28 June 2014 to 21 February 2013 |\n| Table of Provs | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Insert reference to new clause 2A. |\n| 2A | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | ad | New clause to clarify the transitional arrangements implementation of the Standard. |\n| 3(1)(b) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 18 January 2016 | am | Omitting reference to Standard 1.1A.2 as a consequential amendment relating to Standard 1.2.7. |\n| 3(2) | 150 | F2014L0142728 Oct 2014FSC9230 Oct 2014 | 30 Oct 2014 | am | Subclause to update cross-reference. |\n| 3(3) | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | ad | New subclause to clarify the transitional arrangements implementation of the Standard. |\n| 9(e)(iv) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rs | Replacing paragraph as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| 14 | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rs | Replacing clause as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| 15(5) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rep | Editorial note as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| Sch 1 | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Entries for amino acids, carnitine, choline, inositol and nucleotides to correct a typographical error. |","sortOrder":3},{"sectionNumber":"Subdivision 1","sectionType":"division","heading":"Outline of requirements","content":"### Subdivision 1 – Outline of requirements\n\n8 Labelling and related requirements\n\n(1) There must be a label on a package of food for special medical purposes.\n\n(2) Subject to sub clauses (3) and (4), the label must comply with the requirements of Subdivision 2.\n\n(3) The requirements of Subdivision 3 apply instead of Subdivision 2 if the package is an inner package.\n\n(4) The requirements of Subdivision 4 apply instead of Subdivision 2 to transportation outer.\n\n(5) To avoid doubt, this Division does not apply to a food for special medical purposes that is not in a package.","sortOrder":4},{"sectionNumber":"Subdivision 2","sectionType":"division","heading":"General labelling requirements","content":"### Subdivision 2 – General labelling requirements\n\n9 Mandatory information\n\nThe label on a package of food for special medical purposes must include the following information –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food;\n (b) the lot identification of the food;\n (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;\n (d) the minimum or average energy content expressed per given quantity of the food;\n (e) the average quantity or minimum quantity, expressed per given quantity of the food, of –\n\n (i) protein, fat and carbohydrate; and\n (ii) any vitamin, mineral or electrolyte present in the food, if the vitamin, mineral or electrolyte has been added to the food; and\n (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\n (iv) subject to subclauses 14(4) and 15(5) of this Standard, any other substance if a nutrition content claim as defined in Standard 1.2.7 is made in relation to that substance.\n\n10 Mandatory statements\n\n(1) The label on a package of food for special medical purposes must include the following statements –\n\n (a) a statement to the effect that the food must be used under medical supervision;\n (b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the food;\n (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;\n (d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c);\n (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;\n (f) a statement indicating whether or not the food is suitable for use as a sole source of nutrition;\n (g) the statements required by subclause (2) if the food is represented as being suitable for use as a sole source of nutrition;\n (h) the advisory statements required by subclause (3);\n (i) the warning statement required by subclause (4).\n\n(2) For paragraph (1)(g), the required statements are –\n\n (a) a statement to the effect that the food is not for parenteral use; and\n (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 –\n\n (i) the nutrient or nutrients which have been modified; and\n (ii) whether each modified nutrient has been increased, decreased, or eliminated from the food.\n\n(3) For paragraph (1)(h), the required advisory statements are –\n\n (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\n (b) if the food contains aspartame or aspartame-acesulphame salt—a statement to the effect that the food contains phenylalanine; and\n (c) if the food contains guarana or extracts of guarana—a statement to the effect that the food contains caffeine; and\n (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\n (e) a statement to the effect that excess consumption of the food may have a laxative effect if the food contains –\n\n (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\n (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\n (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.\n\nTable 1 to paragraph\n\n| Substance |\n| -------------- |\n| Lactitol |\n| Maltitol |\n| Maltitol syrup |\n| Mannitol |\n| Xylitol |\n\nTable 2 to paragraph\n\n| Substance |\n| ------------ |\n| Erythritol |\n| Isomalt |\n| Polydextrose |\n| Sorbitol |\n\n(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 –\n\n “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”.\n\n> Note: Editorial note:\n\n> 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.\n\n(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.\n\n11 Mandatory declaration\n\n(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 –\n\n (a) an ingredient; or\n (b) an ingredient of a compound ingredient; or\n (c) a food additive or component of a food additive; or\n (d) a processing aid or component of a processing aid.\n\nTable to subclause 11(1)\n\n| Added Sulphites in concentrations of 10 mg/kg or more |\n| --------------------------------------------------------------------------------------------------------------------- |\n| Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains |\n| Crustacea and their products |\n| Egg and egg products |\n| Fish and fish products |\n| Milk and milk products |\n| Peanuts and peanut products |\n\n(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.\n\n> Note: Editorial note:\n\n> Note: The requirement of clause 11 is based on clause 4 of Standard 1.2.3.\n\n12 Labelling of ingredients\n\nThe label on a package of food for special medical purposes must comply with one of the following –\n\n (a) Standard 1.2.4 of this Code;\n (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;\n (c) 21 CFR § 101.4.\n\n13 Date marking of food\n\n(1) A food for special medical purposes must comply with Standard 1.2.5.\n\n(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.\n\n14 Lactose claims in relation to food for special medical purposes\n\n(1) A claim in relation to the lactose content of a food for special medical purposes is prohibited unless expressly permitted by this clause. \n\n(2) 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.\n\n(3) 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 2 g of lactose per 100 g of the food.\n\n(4) If a claim in relation to the lactose content of a food for special medical purposes is made 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.\n\n> Note: Editorial note:\n\n> Note: The requirement of clause 14 is based on clause 15 of Standard 1.2.8.\n\n15 Claims in relation to gluten content of food for special medical purposes\n\n(1) A claim in relation to the gluten content of a food for special medical purposes is prohibited unless expressly permitted by this clause.\n\n(2) A claim to the effect that a food for special medical purposes is gluten free may be made if the food contains –\n\n (a) no detectable gluten; and\n (b) no oats or oat products; and\n (c) no cereals containing gluten that have been malted, or products of such cereals.\n\n(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.\n\n(4) A claim to the effect that a food for special medical purposes contains gluten or is high in gluten may be made.\n\n(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.\n\n16 Legibility requirements\n\nThe label on a package of food for special medical purposes must comply with Standard 1.2.9.","sortOrder":5},{"sectionNumber":"Subdivision 3","sectionType":"division","heading":"Labelling requirements for inner packages","content":"### Subdivision 3 – Labelling requirements for inner packages\n\n17 Labelling requirements for inner packages\n\n(1) There must be a label on an inner package of food for special medical purposes.\n\n(2) The label must include –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food; and\n (b) the lot identification of the food; and\n (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 –\n\n (i) an ingredient; or\n (ii) an ingredient of a compound ingredient; or\n (iii) a food additive or component of a food additive; or\n (iv) a processing aid or component of a processing aid.\n\n \n\nTable to paragraph\n\n| Added Sulphites in concentrations of 10 mg/kg or more |\n| --------------------------------------------------------------------------------------------------------------------- |\n| Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains |\n| Crustacea and their products |\n| Egg and egg products |\n| Fish and fish products |\n| Milk and milk products |\n| Peanuts and peanut products |\n| Sesame seeds and sesame seed products |\n| Soybeans and soybean products |\n| Tree nuts and tree nut products other than coconut from the fruit of the palm Cocos nucifera |\n\n(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.\n\n(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.\n\n(5) The label on an inner package of food for special medical purposes must comply with Standard 1.2.9.\n\n(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.\n\n> Note: Editorial note:\n\n> Note: The requirement of paragraph 17(2)(c) is based on the requirements of clause 4 of Standard 1.2.3.","sortOrder":6},{"sectionNumber":"Subdivision 4","sectionType":"division","heading":"Information requirements for transportation outers","content":"### Subdivision 4 – Information requirements for transportation outers\n\n18 Information required on transportation outers\n\n(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 –\n\n (a) a name or a description of the food sufficient to indicate the true nature of the food; and\n (b) the lot identification of the food; and\n (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.\n\n(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.","sortOrder":7},{"sectionNumber":"SCHEDULE 1","sectionType":"schedule","heading":null,"content":"## SCHEDULE 1\n\nPermitted forms of particular substances\n\n```html\n

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

\n```","sortOrder":8},{"sectionNumber":"SCHEDULE 2","sectionType":"schedule","heading":null,"content":"## SCHEDULE 2\n\nMinimum 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\n\n```html\n

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

\n```\n\n1, 2, and 4 These numbers refer to the corresponding numbers in the footnotes in Schedule 1 in Standard 1.1.1.\n\n3 The higher amount applies only to products intended for children aged one to ten years.","sortOrder":11},{"sectionNumber":"Amendment History","sectionType":"division","heading":"Amendment History","content":"### Amendment History\n\nThe Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.\n\nThese 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.\n\nAbout this compilation\n\nThis is a compilation of Standard 2.9.5 as in force on 18 January 2016 (up to Amendment No. 150). It includes any commenced amendment affecting the compilation to that date.\n\nPrepared by Food Standards Australia New Zealand on 18 January 2016.\n\nUncommenced amendments or provisions ceasing to have effect\n\nTo 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.\n\nThe following abbreviations may be used in the table below:\n\nad = added or inserted am = amended\n\nexp = expired or ceased to have effect rep = repealed\n\nrs = repealed and substituted\n\nStandard 2.9.5 was published in the Food Standards Gazette No. FSC 74 on 28 June 2012 as part of Amendment No. 132 (F2012L01347 – 27 June 2012) and has been amended as follows:\n\n| Clause affected | A’ment No. | FRLI registrationGazette | Commencement(Cessation) | How affected | Description of amendment |\n| --------------- | ---------- | --------------------------------------------------------------------- | ----------------------- | ------------ | ------------------------------------------------------------------------------------------------------------------------- |\n| C’ment | 139 | F2012L0134727 June 2012as am byF2013L0025321 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Commencement date for the Standard brought forward from 28 June 2014 to 21 February 2013 |\n| Table of Provs | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Insert reference to new clause 2A. |\n| 2A | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | ad | New clause to clarify the transitional arrangements implementation of the Standard. |\n| 3(1)(b) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 18 January 2016 | am | Omitting reference to Standard 1.1A.2 as a consequential amendment relating to Standard 1.2.7. |\n| 3(2) | 150 | F2014L0142728 Oct 2014FSC9230 Oct 2014 | 30 Oct 2014 | am | Subclause to update cross-reference. |\n| 3(3) | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | ad | New subclause to clarify the transitional arrangements implementation of the Standard. |\n| 9(e)(iv) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rs | Replacing paragraph as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| 14 | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rs | Replacing clause as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| 15(5) | 138 | F2013L0005014 Jan 2013FSC 8018 Jan 2013 | 21 Feb 2013 | rep | Editorial note as a consequential amendment relating to Standard 1.2.7 originally to have commenced on 28 June 2014. |\n| Sch 1 | 139 | F2013L0024721 Feb 2013FSC8121 Feb 2013 | 21 Feb 2013 | am | Entries for amino acids, carnitine, choline, inositol and nucleotides to correct a typographical error. |","sortOrder":12}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":2500},"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The Standard maintains its original scope regulating the sale, composition, and labelling of foods for special medical purposes. Amendment history shows technical updates, transitional arrangements, and corrections to cross-references, but no fundamental expansion beyond the original medical food regulatory framework."},"complexity_factors":["18 clauses across 4 divisions plus 2 detailed technical schedules","Extensive cross-referencing to at least 12 other Standards plus EU Directive 2000/13/EC and US FDA regulations (21 CFR)","Three-tier labelling system with different requirements for general packages, inner packages, and transportation outers","Schedule 1 specifies permitted chemical forms for over 50 substances including vitamins, minerals, amino acids, and nucleotides","Schedule 2 prescribes minimum and maximum nutritional content per megajoule for sole-source nutrition products","Nested conditional logic and exceptions (e.g., clause 7(2) creates exceptions to the compositional requirements in 7(1))","Multiple defined terms including 'responsible institution', 'inner package', and 'majority seller' with specific statutory meanings"],"plain_english_summary":"This Standard sets rules for food for special medical purposes (FSMP): medically supervised, specially formulated products for people who cannot meet nutritional needs from a normal diet. It affects manufacturers, health services, pharmacies, dietitians and patients, and matters because it restricts sales to medical/responsible institutions, mandates nutrient composition for sole‑nutrition products, and imposes specific labelling and claim limits to protect safety and prevent inappropriate therapeutic claims."},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"Amendments and transitional clauses altered implementation details rather than core policy. The Amendment History records a brought‑forward commencement date and insertion of clause 2A clarifying transitional/deemed compliance (Amendment No.139, cl.2A), updates to cross‑references (Amendments Nos.138 and 150, cl.3(2) and 3(3)), replacement of certain paragraphs and clauses as consequential amendments (e.g. cl.9(e)(iv), cl.14), and typographical corrections to Schedule 1 (Amendment No.139). These changes adjust timing, references and technical entries but do not replace the Standard’s principal scope (definition, sale restrictions, composition and labelling requirements)."},"complexity_factors":["Detailed definition with multiple exclusions (cl.1 and cl.1(2))","Sales restrictions limiting retail channels and a time‑based majority‑seller test (cl.5(1),(3))","Extensive labelling regime with multiple mandatory statements, advisory/warning requirements and inner/outer package rules (Div.4, cls.8–18)","Numeric compositional minima and maxima for many nutrients per MJ and age‑specific variants (Schedule 2, cl.7(1))","Large Schedule of permitted chemical/forms for vitamins, minerals, amino acids and other substances (Schedule 1; cl.6(1))","Cross‑references to numerous other Standards and selective exemptions/incorporations (cl.3 and multiple notes)","Transitional/deemed‑compliance and amendment history creating phased implementation complexities (cl.2A and Amendment History)","Multiple labelling options referencing alternative legal regimes (cl.12 referencing Standard 1.2.4, EU Directive, 21 CFR)","Separate rules for inner packages and transportation outers that alter labelling obligations (cls.17–18)","Specific content‑claim controls (lactose and gluten clauses 14–15) that constrain marketing language"],"plain_english_summary":"This Standard defines which products are \"food for special medical purposes\" and then prescribes who may sell them, what they may contain, and required labelling. It affects manufacturers, importers, medical practitioners, pharmacies, responsible institutions and patients. Mechanically, suppliers must comply with the schedules of permitted ingredient forms and nutrient minima/maxima for sole‑nutrition products, include mandatory statements and allergen declarations, and limit consumer sales to authorised sellers. Producers and sellers bear compliance costs; suppliers decide formulations and labels; consumer access is restricted to specific channels."}},"importantCases":[],"_links":{"self":"/api/acts/f2012l01347","history":"/api/acts/f2012l01347/history","analysis":"/api/acts/f2012l01347/analysis","conflicts":"/api/acts/f2012l01347/conflicts","importantCases":"/api/acts/f2012l01347/important-cases","documents":"/api/acts/f2012l01347/documents"}}