Australia New Zealand Food Standards Code - Standard 2.9.5 - Food for Special Medical Purposes
Subdivision 2General labelling requirements
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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 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.
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.
Division Subdivision 2 - Australia New Zealand Food Standards Code - Standard 2.9.5 - Food for Special Medical Purposes - General labelling requirements | Zoe
(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”.
Note: Editorial note:
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
(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.
Note: Editorial note:
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 in relation to the lactose 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 lactose free may be made if the food contains no detectable lactose.
(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.
(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.
Note: Editorial note:
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.
16 Legibility requirements
The label on a package of food for special medical purposes must comply with Standard 1.2.9.