AUSTRALIA NEW ZEALAND FOOD AUTHORITY

VARIATIONS TO THE FOOD STANDARDS CODE

(AMENDMENT NO. 55)

1. Preamble

The variations set forth in the Schedule below are variations to the Food Standards Code (hereinafter called 'the Code') which was published by the National Health and Medical Research Council in the Commonwealth of Australia Gazette, No. P 27, on 27 August 1987, and which has been varied from time to time.

The Schedule contains variations adopted by the Australia New Zealand Food Standards Council in July and August 2001.

These variations are published pursuant to section 32 of the Australia New Zealand Food Authority Act 1991.

2. Citation

These variations may be collectively known as Amendment No. 55 to the Code.

3. Commencement

These variations commence on the date of gazettal, with the exception of Items [6] and [18] which will commence on 16 September 2001.

4. Correction of Typographical Error

Amendment 54 published on 14 June 2001 contained a typographical error on page 3 (Item [1.3]).  The reference to the Formula weight for Bromo-chloro-dimethylhydantoin should read ‘241.5’ not ‘41.5’.

Note:  These variations were published in the Commonwealth of Australia Gazette No. P 23 on 30 August 2001.

SCHEDULE

[1] Standard A1 is varied by –

[1.1] inserting in columns 1 and 2 respectively of the Schedule Part 1, Food Additive Code Numbers (Alphabetical Order), immediately following the entry for Natamycin –

Neotame Number pending

[1.2] inserting in columns 1 and 2 respectively of the Schedule Part 2, Food Additive Code Numbers (Numerical Order), immediately before the entry for Curcumin –

Neotame  Number pending

[2] Standard A5 is varied by omitting clause 2A, paragraphs (a) and (b) and associated note.

[3] Standard A11 is varied by –

[3.1] inserting in columns 1 and 2 respectively of the Schedule, immediately following the entry for Natamycin –

Neotame Addendum 10

[3.2] inserting immediately following Addendum 9, Specifications for phytosterol esters derived from vegetable oils, the following –

ADDENDUM 10

SPECIFICATION FOR NEOTAME

Neotame (CAS Number 165450-17-9) is a dipeptide methyl ester derivative, and is prepared by the reductive alkylation of N-L--aspartyl-L-phenylalanine 1-methyl ester (aspartame).

Formula:  C20H30N2O5

Molecular Weight:  378.47 

Physical Tests

Appearance:  Powder

Colour:  White to off-white

Solubility in water:  4.75% (w/w) at 60C, soluble in ethanol and ethyl acetate

Refractive index:  1.3338

(0.5% aqueous solution of Neotame at 20oC)

pH:  5.80

(0.5% aqueous solution of Neotame at 20oC)

Octanol/H2O Partition coefficient:  Log10P=0.917

pKa:  3.03/8.08

Chemical

Melting Range:  80.9C – 83.4C

Assay: Not less than 97.0% and not more than 102% of Neotame calculated on a dry basis.

N-(3,3-dimethylbutyl)-L

--aspartyl-L-phenylalanine: Not more than 1.5%

Lead (Pb):  Not more than 2 mg/kg

Other Related Substances: Not more than 2.0%

Water:  Not more than 5.0%

Residue on Ignition:  Not more than 0.2%

Specific Rotation: []20:  between –40.0 and –43.4, calculated on a dried basis.

[4] Standard A14 is varied by -

[4.1] inserting in columns 1 and 2 respectively of Schedule 1 each chemical (shown in bold type) and its associated food and maximum residue limit for that food listed below -

Sulphadoxine

Cattle milk 0.1

Edible offal (mammalian) 0.1

Meat (mammalian)  0.1

[4.2] omitting from columns 1 and 2 respectively of Schedule 1 in relation to each chemical (shown in bold type), the food and maximum the maximum residue limit shown below -

Neomycin 

Milks (in the fat)  0.02

Oxytetracycline 

Salmon, Pacific  0.2

[4.3] inserting in columns 1 and 2 respectively of Schedule 1 each chemical (shown in bold type) and its associated food and maximum residue limit for that food, listed below -

Chlortetracycline 

Cattle kidney 0.6

Cattle liver 0.3

Eggs 0.2

Pig kidney 0.6

Pig liver 0.3

Lincomycin

Cattle milk 0.02

Eggs 0.2

Poultry, edible offal of 0.1

Poultry meat  0.1

Neomycin 

Milk 0.5

Oxytetracycline 

Kidney of cattle, goats, pigs and sheep 0.6

Liver of cattle, goats, pigs and sheep  0.3

Salmonids 0.2

Spectinomycin

Eggs 2

Sulphadiazine

Cattle milk 0.1

Virginiamycin 

Sheep, edible offal of 0.2

Sheep meat 0.1

[4.4] omitting from column 2 of Schedule 1 the maximum residue limit in relation to each chemical (shown in bold type) and each food, substituting the maximum residue limit shown below -

Lasalocid 

Edible offal (mammalian) 0.7

Lincomycin

Edible offal (mammalian)

[except sheep, edible offal of] 0.2

Meat (mammalian)

[except sheep meat] 0.2

Oxytetracycline 

Meat (mammalian)  0.1

Poultry, edible offal of  0.6

Poultry meat  0.1

Spectinomycin

Poultry, edible offal of 1

Poultry meat 1

[5] Standard A18 is varied by inserting into column 1 of the Table to clause 2 –

Food derived from insect and potato leafroll virus-protected potato lines RBMT21-129, RBMT21-350, and RBMT22-82.

Food derived from insect and potato virus Y-protected potato lines RBMT15-101, SEM15-02 and SEM15-15.

Food derived from insect-protected Bt-176 corn.

Food derived from insect-protected, glufosinate ammonium-tolerant Bt-11 corn.

Food derived from insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, and SPBT02-05

[6] Standard C1 is varied by -

[6.1] inserting immediately after the Standard Heading Meat, Game Meat and Related Products –

Subclauses 7(2) and 7(3) are Australia Only provisions

[6.2] inserting immediately following subclause 7(1) -

(2) Subject to subclause (3), bovine meat and food ingredients derived from bovines must be derived from animals free of bovine spongiform encephalopathy.

(3) Subclause (2) does not apply to -

(a) collagen from bovine skins and hides (including sausage casings produced from this type of collagen;

(b) bovine fats and bovine tallows;

(c) gelatine sourced from bovines; and

(d) milk and other dairy products sourced from bovines.

[7] Standard 1.3.1 of Volume 1 is varied by –

[7.1] deleting the Purpose commentary and substituting –

A food additive is any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5.  It or its by-products may remain in the food.  Food additives are distinguishable from processing aids (see Standard 1.3.3) and vitamins and minerals added to food for nutritional purposes (see Standard 1.3.2).

This Standard regulates the use of food additives in the production and processing of food.  A food additive may only be added to food where expressly permitted in this standard.  Additives can only be added to food in order to achieve an identified technological function according to Good Manufacturing Practice.

Standard A11 prescribes standards for the identity and purity of food additives.

[8] Standard 1.1.2 is amended by -

[8.1] deleting the definition of chocolate under Interpretation, substituting -

chocolate means the confectionery product characterised by the presence of cocoa bean derivatives –

(a) prepared from a minimum of 200 g/kg of cocoa bean derivatives; and

(b) which contains no more than 50 g/kg of edible oils, other than cocoa butter or dairy fats.

[8.2] inserting –

peanut butter means a peanut based spread containing no less than 850 g/kg of peanuts.

[9] Standard 1.2.1 is varied by omitting paragraph 2(2)(l), substituting –

(l) subclause 3(2) of Standard 2.6.3; and

(m) subclause 3(3) of Standard 2.6.4; and

(n) subclause 3(4) of Standard 2.6.4.

[10] Standard 1.2.4 is varied by –

[10.1] inserting in columns 1 and 2 respectively of Schedule 2, Part 1, Food Additive Code Numbers (alphabetical order), immediately following the entry for Natamycin or pimaricin –

Neotame -

[10.2] inserting in columns 1 and 2 respectively of Schedule 1, Part 2, Food Additive Code Numbers (numerical order), immediately before the entry for Curcumin –

Neotame -

[11] Standard 1.2.8 is varied by –

[11.1] inserting in clause 1, immediately following the definition of carbohydrate -

dietary fibre means that fraction of the edible part of plants or their extracts, or synthetic analogues that -

(a) are resistant to the digestion and absorption in the small intestine, usually with complete or partial fermentation in the large intestine; and

(b) promote one or more of the following beneficial physiological effects -

(i) laxation;

(ii) reduction in blood cholesterol;

(iii) modulation of blood glucose;

and includes polysaccharides, oligosaccharides (degree of polymerisation > 2) and lignins.

[11.2] deleting subclause 5(5), substituting -

(5) The nutrition information panel must include a declaration of the presence or absence of dietary fibre in accordance with subclause (7), where a nutrition claim is made in respect of -

(a) fibre; or

(b) any specifically named fibre; or

(c) sugars; or

(d) any other type of carbohydrate.

[11.3] deleting clause 18, substituting -

18 Methods of analysis to determine total dietary fibre and specifically named fibre content of food

(1) Subject to subclause (2), the methods set out in the Table to this subclause are the prescribed methods of analysis for the determination of total dietary fibre and any specifically named fibre content of food for the purposes of nutrition labelling in this standard.

Table to subclause 18(1)

(2) The results obtained using the analytical methods outlined in column 2 of the Table to subclause 18(1) must be summed together after ensuring that there is no double counting of any specifically named fibre.

[12] Standards 1.3.1 of Volumes 1 and 2 are varied by -

[12.1] omitting the maximum level of 290 mg/kg in relation to the entry for preserved cherries known as maraschino cherries, cocktail cherries or glace cherries in item 4.3 of Schedule 1, and substituting –

200 mg/kg

[12.2] inserting in columns 1 and 2 respectively of Schedule 2 (Alphabetical listing), immediately following the entry for Monostarch phosphate –

-                          Neotame (technological use consistent with clause 4 only)

[12.3] inserting in columns 1 and 2 respectively of Schedule 2 (Numeric listing), immediately before the entry for Calcium carbonates –

-                          Neotame (technological use consistent with clause 4 only)

[13] Standard 1.3.1 of Volume 2 is varied by deleting the Purpose commentary and substituting –

A food additive is any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5.  It or its by-products may remain in the food.  Food additives are distinguishable from processing aids (see Standard 1.3.3) and vitamins and minerals added to food for nutritional purposes (see Standard 1.3.2).

This Standard regulates the use of food additives in the production and processing of food.  A food additive may only be added to food where expressly permitted in this standard.  Additives can only be added to food in order to achieve an identified technological function according to Good Manufacturing Practice.

[14] Standard 1.3.2 is varied by inserting into the Purpose, immediately after the words Standard 2.4.2 –

, the addition of vitamins to formulated caffeinated beverages in Standard 2.6.4

[15] Standard 1.3.4 is varied by inserting in the Schedule, immediately following Specification for phytosterol esters derived from vegetable oils –

Specification for Neotame

Neotame (CAS Number 165450-17-9) is a dipeptide methyl ester derivative, and is prepared by the reductive alkylation of N-L--aspartyl-L-phenylalanine 1-methyl ester (aspartame).

Formula:  C20H30N2O5

Molecular Weight:  378.47 

Physical Tests

Appearance:  Powder

Colour:  White to off-white

Solubility in water:  4.75% (w/w) at 60C, soluble in ethanol and ethyl acetate

Refractive index:  1.3338

(0.5% aqueous solution of Neotame at 20oC)

pH:  5.80

(0.5% aqueous solution of Neotame at 20oC)

Octanol/H2O Partition coefficient:  Log10P=0.917

pKa:  3.03/8.08

Chemical

Melting Range: 80.9C – 83.4C

Assay: Not less than 97.0% and not more than 102% of Neotame calculated on a dry basis.

N-(3,3-dimethylbutyl)-L

--aspartyl-L-phenylalanine: Not more than 1.5%

Lead (Pb):  Not more than 2 mg/kg

Other Related Substances: Not more than 2.0%

Water:  Not more than 5.0%

Residue on Ignition:  Not more than 0.2%

Specific Rotation: []20:  between –40.0 and –43.4, calculated on a dried basis.

[16] Standard 1.4.2 is varied by -

[16.1] inserting in columns 1 and 2 respectively of Schedule 1 each chemical (shown in bold type) and its associated food and maximum residue limit for that food, listed below -

[16.2] omitting from columns 1 and 2 respectively of Schedule 1, in relation to each chemical (shown in bold type), the food and maximum the maximum residue limit shown below -

[16.3] inserting in columns 1 and 2 respectively of Schedule 1 each chemical (shown in bold type) and its associated food and maximum residue limit for that food, listed below -

[16.4] omitting from column 2 of Schedule 1 the maximum residue limit in relation to each chemical (shown in bold type) and each food, substituting the maximum residue limit shown below -

[17] Standard 1.5.2 is varied by inserting into column 1 of the Table to clause 2 -

Food derived from insect and potato leafroll virus-protected potato lines RBMT21-129, RBMT21-350, and RBMT22-82.

Food derived from insect and potato virus Y-protected potato lines RBMT15-101, SEM15-02 and SEM15-15.

Food derived from insect-protected Bt-176 corn.

Food derived from insect-protected, glufosinate ammonium-tolerant Bt-11 corn.

Food derived from insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, and SPBT02-05

[18] Standard 2.2.1 is varied by -

[18.1] inserting immediately after the Standard Heading Meat and Meat Products -

Clause 11 is an Australia only provision

[18.2] inserting immediately following clause 10 -

11 Meat and meat products must be derived from cattle free of bovine spongiform encephalopathy

(1) Subject to subclause (2), bovine meat and food ingredients derived from bovines must be derived from animals free from bovine spongiform encephalopathy.

(2) Subclause (1) does not apply to -

(a) collagen from bovine skins and hides (including sausage casings produced from this type of collagen; and

(b) bovine fats and bovine tallows; and

(c) gelatine sourced from bovines; and

(d) milk and other dairy products sourced from bovines.

[19] Volume 2 is amended by inserting immediately following Standard 2.3.1 -

Standard 2.3.2

Jam and Related Products

Purpose

This Standard defines jam and marmalade and includes compositional requirements for the manufacture of those products.

Table of Provisions

1 Interpretation

2 Composition of jam

Clauses

1 Interpretation

In this Code -

jam means the product prepared by processing one or more of the following –

(a) fruit; and

(b) sugars or honey; and

(c) fruit juice; and

(d) concentrated fruit juice; and

(e) water extracts of fruit;

and includes conserve, but excludes marmalade.

2 Composition of jam

(1)              Each kilogram of jam must be made from no less than 400 grams of the fruit or fruits named in the label.

(2)              Jam must contain no less than 650 g/kg of water-soluble solids.

[20] Standard 2.5.1 is varied by-

[20.1]  deleting the Table to subclause 2(1), substituting –

Table to subclause 2(1)

[20.2]  deleting the Table to subclause 3(1) of Standard 2.5.1, substituting –

Table to subclause 3(1)

[21] Standard 2.5.2 is varied by deleting subclause 2(1), substituting -

(1) Subject to subclause (2), cream must contain no less than 350 g/kg of milk fat.

[22] Standard 2.5.3 is varied by deleting the Table to subclause 2(3), substituting –

Table to subclause 2(3)

[23] Standard 2.5.6 varied by deleting clause 1 and clause 2, substituting -

1 Interpretation

In this Code –

ice cream means a sweet frozen food made from cream or milk products or both, and other foods, and is generally aerated.

2 Composition

Ice cream must contain no less than –

(a) 100 g/kg of milk fat; and

(b) 168 g/litre of food solids.

[24] Standard 2.6.1 is varied by deleting clause 2, inserting –

2 Composition

Fruit juice or vegetable juice may have added to it any of the following foods –

(a) for vegetable juice, sugars;

(b) for fruit juice, no more than 40 g/kg of sugars; and

(c) salt; and

(d) herbs and spices.

[25] Volume 2 is amended by deleting Standard 2.6.2 substituting -

Standard 2.6.2

Non-Alcoholic Beverages and Brewed Soft Drinks

Purpose

This Standard deals with packaged waters and water-based beverages which contain food additives and in certain cases, nutritive substances.  The Standard defines a number of products and sets certain compositional requirements for packaged water, electrolyte drinks and brewed soft drinks.  Labelling requirements specific to electrolyte drinks are included in this Standard.  This Standard also prohibits the labelling or presentation of non-alcoholic beverages in such a way as to suggest the product is an alcoholic beverage.

Table of Provisions

1 Interpretation

2 Composition of packaged water

3 Composition of brewed soft drink

4 Composition of fruit drinks

5 Non-alcoholic beverages not to be labelled/presented as alcoholic beverages

6 Composition of electrolyte drinks and electrolyte drink bases

7 Labelling of electrolyte drinks and electrolyte drink bases

8 Claims in relation to the tonicity of electrolyte drinks

Clauses

1 Interpretation

In this Code –

brewed soft drink means the product prepared by a fermentation process from water with fruit and/or vegetable extractives or fruit and/or vegetable infusions, and sugar.

electrolyte drink means a drink formulated and represented as suitable for the rapid replacement of fluid, carbohydrates, electrolytes and minerals.

electrolyte drink base means a solid or liquid which when made up, makes an electrolyte drink.

fruit drink means a product prepared from one or more of the following -

(a) fruit juice; and

(b) fruit purée; and

(c) concentrated fruit juice; and

(d) concentrated fruit puree; and

(e) comminuted fruit; and

(f) orange peel extract; and

(g) water; and

(h) mineral water; and

(i) mineralised water.

mineral water or spring water means ground water obtained from subterranean water-bearing strata that, in its natural state, contains soluble matter.

non-alcoholic beverage means -

(a) packaged water; or

(b) a water-based beverage which may or may not contain other foods, except for alcoholic beverages; or

(c) electrolyte drinks.

2 Composition of packaged water

(1) Water presented in packaged form may or may not contain added carbon dioxide.

(2) Water presented in packaged form must not contain the substances listed in column 1 of the Table in greater corresponding proportion than that specified in column 2 of the Table to this subclause.

Table to subclause (2)2

3 Composition of brewed soft drink

Brewed soft drink must contain no more than 1.15% alcohol/volume.

4 Composition of fruit drinks

Fruit drinks must contain no less than 50 mL/L of fruit, except in the case of passionfruit drink which must contain no less than 35 mL/L of passionfruit, prepared from any of the sources specified in the definition for fruit drink in paragraphs 1(a) to (f).

5 Non alcoholic beverages not to be labelled/presented as alcoholic beverages

Non alcoholic beverages must not be labelled or otherwise presented for sale in a form which expressly or by implication suggests that the product is an alcoholic beverage.

6 Composition of electrolyte drinks and electrolyte drink bases

(1) An electrolyte drink, or an electrolyte drink base when made up, must contain no less than 10 mmol/L of sodium.

(2) An electrolyte, or an electrolyte drink base when made up according to directions, must contain –

(a) no less than 50 g/L and no more than 100 g/L total -

(i) glucose syrup; and

(ii) dextrose; and

(iii) fructose; and

(iv) maltodextrin; and

(b) no more than 50 g/L fructose.

(3) An electrolyte drink, or an electrolyte drink base when made up, may contain:

(a) calcium phosphates; and

(b) potassium phosphates; and

(c) calcium citrates; and

(d) potassium citrates; and

(e) sodium citrates; and

(f) potassium carbonates, including potassium bicarbonate; and

(g) potassium chloride; and

(h) calcium chloride; and

(i) sodium chloride; and

(j) calcium lactate; and

(k) magnesium lactate; and

(l) magnesium sulphate.

7 Labelling of electrolyte drinks and electrolyte drink bases

The label on a package of electrolyte drink or electrolyte drink base, must include a declaration, as ready to drink -

(a) the average per 100 mL -

(i) energy value; and

(ii) total carbohydrate present, including each type of monosaccharide and disaccharide; and

(iii) milligrams and millimoles of the added minerals and electrolytes; and

(b) the recommended volume and frequency of use.

8 Claims in relation to the tonicity of electrolyte drinks

(1) A claim that an electrolyte drink is isotonic may only be made if the electrolyte drink has an average osmolality of 250 - 340 milliOsmol/L.

(2) Where a claim is made that an electrolyte drink is isotonic, hypertonic or hypotonic, the osmolality of the electrolyte drink as measured in milliOsmol/L must be declared on the label of the package.

(3) The label on a package of isotonic electrolyte drink may include words to the effect that the product is designed to promote the availability of energy and to prevent or treat mild dehydration that may occur as a result of sustained strenuous exercise.

[26] The Food Standards Code is varied by inserting immediately following Standard 2.6.3 -

Standard 2.6.4

Formulated Caffeinated Beverages

Purpose

The purpose of this Standard is to regulate non-alcoholic water-based flavoured formulated caffeinated beverages that are manufactured for the purpose of enhancing mental performance.

Table of Provisions

1 Interpretation

2 Composition

3 Labelling

1 Interpretation

In this Standard –

caffeine means all caffeine present from whatever source in a formulated caffeinated beverage.

formulated caffeinated beverage means a non-alcoholic water-based flavoured beverage which contains caffeine and may contain carbohydrates, amino acids, vitamins and other substances, including other foods, for the purpose of enhancing mental performance.

one day quantity in relation to formulated caffeinated beverage, means the maximum amount of that food that should be consumed in one day in accordance with the directions specified in the label.

2 Composition

(1) A formulated caffeinated beverage must contain no less than 145 mg/L and no more than 320 mg/L of caffeine.

(2) A formulated caffeinated beverage may contain the substances listed in column 1 of the Table to this subclause, provided the amount of that substance present in the food is no more than the amount specified in relation to that substance in column 2 of the Table.

Table to subclause 2(2)

(3) A formulated caffeinated beverage must not be mixed with a non-alcoholic beverage as standardised under Standard 2.6.2.

3 Labelling

(1) The label on a package of formulated caffeinated beverage must include declarations of the average quantities, per serving size and per 100 mL of –

(a) caffeine, expressed in milligrams; and

(b) the substances listed in column 1 of the Table to subclause 2(2) expressed in the units included in column 2 of the Table.

(2) The declarations under subclause 3(1) may be adjacent to or follow a nutrition information panel on the label of a package of formulated caffeinated beverage, provided that the declarations are clearly distinguished from the nutrition information required by Standard 1.2.8.

(3) The label on a package of formulated caffeinated beverage must include advisory statements to the effect that –

(a) the food contains caffeine; and

(b) the food is not recommended for –

(i) children; and

(ii) pregnant or lactating women; and

(iii) individuals sensitive to caffeine.

(4) The label on a package of formulated caffeinated beverage that contains one or more of the substances in the Table to subclause 2(2) must include an advisory statement to the effect that -

 ‘Consume no more than [amount of one-day quantity (as cans, bottles or mL )] per day’.

(5) Where a formulated caffeinated beverage is not required to bear a label pursuant to clause 2 of Standard 1.2.1, the advisory statements under subclauses 3(3) and 3(4) must be -

(a) displayed on or in connection with the display of the food; or

(b) provided to the purchaser on request.

Editorial note:

The advised one-day quantity is calculated from the permissions in the Table to subclause 2(2) as it relates to the concentration of substances in the product.  The substance that yields the lowest equivalent amount will determine the advised consumption limit. 

For example:

The equivalent amount in Column 4 is calculated as  Column 3 x 1000
            Column 2

In this example niacin presents as the most limiting substance, and therefore, the advised consumption limit for product X would be 500 mL.  If product X is packaged in 250 mL cans, the advised consumption limit may also be expressed as ‘two cans’ – for example –

‘consume no more than 500 mL per day’ or ‘consume no more than two cans per day’.

(6) A formulated caffeinated beverage is not a ‘claimable food’ in Standard 1.3.2.

(7) The label on a package of formulated caffeinated beverage must not include declarations of the quantities of vitamins present in the food expressed as a proportion or multiple of the -

(a) Recommended Dietary Intakes; or

(b) Estimated Safe and Adequate Daily Dietary Intakes;

of that vitamin.