Federal Register of Legislation - Australian Government

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Food Standards as made
This instrument amends the Australia New Zealand Food Standards Code through variations adopted by the Australia New Zealand Food Standards Council.
Administered by: Health
General Comments: This Standard was made by the Australia New Zealand Food Authority on 14 June 2001.
Exempt from sunsetting by the Legislative Instruments Act 2003 s 54(1), Food Standards Australia New Zealand Act 1991 s 82(2)
Registered 09 Dec 2008
Gazetted 14 Jun 2001
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

AUSTRALIA NEW ZEALAND FOOD AUTHORITY

 

VARIATIONS TO THE FOOD STANDARDS CODE

 

(AMENDMENT No. 54)

 

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 March and June 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. 54 to the Code.

 

3.           Commencement

 

These variations commence on the date of gazettal.

 

 

SCHEDULE

 

[1]          Standard A11 is varied by -

 

[1.1]       inserting immediately following paragraph (1)(u) -

 

(v)          Addendum 8 means Addendum 8 to this Standard.;

 

[1.2]       inserting in columns 1 and 2 respectively of the Schedule, immediately following the entry for Bromelain, the entries listed in column 1 and column 2 as set out below –

 

Column 1

 

Substance

Column 2

 

Reference to Specification

Bromo-chloro-dimethylhydantoin  

Addendum 8

 

[1.3]       inserting immediately after Addendum 7 -

 


ADDENDUM 8

 

SPECIFICATIONS FOR BROMO-CHLORO-DIMETHYLHYDANTOIN

 

Bromo-chloro-dimethylhydantoin (CAS Number: 126-06-7)

 

Formula:                                  C5H6BrCIN2O2

Formula weight:                       41.5

Chemical Properties

Appearance:                            Solid or free flowing granules

Colour:                                    White

Odour:                                     Faint halogenous odour

Melting Point                           163-1640C

Specific gravity                        1.8-2

Solubility in water                     0.2g/100g at 25ºC

Stability                                   Stable when dry and uncontaminated

Chemical Tests:

Manufacturing process:            Solid dimethylhydantoin (DMH) is dissolved in water with bromine and chlorine.  The reaction is 0.5 mole bromine and 1.5 mole chlorine for one mole DMH.  During the reaction the pH is kept basic by the addition of caustic soda.  The wet product is transferred to a drier where it is dried to a powder at low temperature.  The powder may then be tableted or granulated.

Assay:

Procedure:                               Various analytical methods exist for analysis, namely, GLC, HPLC, UV and NMR.  HPLC offers the best sensitivity.

 

[1.4]       inserting immediately after ADDENDUM 8, the following –

 

ADDENDUM 9

 

SPECIFICATION FOR PHYTOSTEROL ESTERS DERIVED FROM VEGETABLE OILS

 

Phytosterol esters are phytosterols derived from edible vegetable oils esterified with long-chain fatty acids derived from edible vegetable oils. 

 

Phytosterol esters + free phytosterols (%)        min.        94

Free phytosterols (%)                                      max.       10

Steradienes (%)                                               max.       0.3

Fatty acid methylester (%)                               max.       0.5

Iron, Fe (ppm)                                                 max.       1.0

Copper, Cu (ppm)                                           max.       0.5

Moisture (%)                                                   max.       0.1

Trans fatty acids (%)                                        max.       1.0

Sterol profile (%) as below -

Cholesterol                                                      min.        0.0         max.       2.0

Brassicasterol                                                  min.        0.0         max.       6.0

Campesterol                                                    min.        20.0       max.       29.0

Campestanol                                                   min.        0.0         max.       6.0

Stigmasterol                                                     min.        12.0       max.       23.0


β-Sitosterol                                                     min.        42.0       max.       55.0

β-Sitostanol                                                     min.        0.0         max.       2.5

D5-Avenasterol                                               min.        0.0         max.       4.0

D7-Stigmastenol                                              min.        0.0         max.       2.0

D7-Avenasterol                                               min.        0.0         max.       2.0

Other                                                              min.        0.0         max.       6.0

 

[2]          Standard A16 is varied by inserting in the Group II, Table II, the entries listed in column 1 and column 2 respectively as set out below -

 

Column 1

 

Substance

Column 2

 

Maximum permitted residue (mg/kg)

Bromo-chloro-dimethylhydantoin

1.0 (available chlorine)

1.0 (inorganic bromide)

2.0 (dimethylhydantoin)

 

[3]          Standard A19 is varied by deleting the Table to clause 2, substituting –

 

Table to clause 2

 

Column 1

 

Novel Food

Column 2

 

Conditions of Use

phytosterol esters

May only be added to food -

 

(1) according to Standard G2 or G5 and Standard A11; and

 

(2) where the total fatty acid present in the food is not more than 280 g/kg of saturated fatty acids.

 

The name ‘phytosterol ester or plant sterol esters’ must be used when declaring the ingredient in the ingredient list, as prescribed in clause 5 of Standard A1.

 

The label on or attached to a package of food containing phytosterol esters must include statements to the effect that -

 

1.  the product should be consumed in moderation as part of a diet low in saturated fats and high in fruit and vegetables;

 

2.  the product is not recommended for infants, children and pregnant or lactating women unless under medical supervision; and

 

3.  consumers on cholesterol-lowering medication should seek medical advice on the use of this product in conjunction with their medication.

 

[4]          Standard G2 is varied by-

 

[4.1]       deleting after subparagraph (1)(b)(ii)(H), the following –

 

              (I)           not more than 5 g/kg of polyglycerol esters of fatty acids.


[4.2]       inserting immediately after subparagraph (1)(b)(ii)(H), the following –

 

              (I)          not more than 5 g/kg of polyglycerol esters of fatty acids;

              (J)          not more than 137 g/kg of phytosterol esters.

 

[5]          Standard G5 is varied by -

 

[5.1]       deleting after paragraph 2(3)(m), the following -

 

              (n)          starch.

 

[5.2]       inserting immediately after paragraph 2(3)(m), the following –

 

              (n)          starch;

              (o)          not more than 137 g/kg of phytosterol esters.

 

[6]          Standard 1.2.3 is varied by inserting into Columns 1 and 2 respectively of the Table to clause 2, the following  –

 


Food regulated in Standard 2.4.2 containing phytosterol esters.

 

Statements to the effect that -

 

1.  the product should be consumed in moderation as part of a diet low in saturated fats and high in fruit and vegetables;

 

2.  the product is not recommended for infants, children and pregnant or lactating women unless under medical supervision; and

 

3.  consumers on cholesterol-lowering medication should seek medical advice on the use of this product in conjunction with their medication.

 

[7]          Standard 1.3.3 is varied by inserting in the Table to clause 12, immediately following the entry for Benzoyl peroxide, the following entries listed below -

 





Substance

Food

Maximum permitted residue

(mg/kg)

Bromo-chloro-dimethylhydantoin

All foods

1.0 (available chlorine)

1.0 (inorganic bromide)

2.0 (dimethylhydantoin)

 

[8]          Standard 1.3.4 is varied by -

 

[8.1]       inserting in the Schedule, immediately following the entry for oxidised polyethylene-

 

Specification for Bromo-chloro-dimethylhydantoin

 

Bromo-chloro-dimethylhydantoin (CAS Number: 126-06-7)

 

Formula:                                                          C5H6BrCIN2O2

Formula weight:                                               241.5


Chemical Properties

Appearance:                                                    Solid or free flowing granules

Colour:                                                            White

Odour:                                                             Faint halogenous odour

Melting Point                                                   163-1640C

Specific gravity                                                1.8-2

Solubility in water                                             0.2g/100g at 25ºC

Stability                                                           Stable when dry and uncontaminated

Chemical Tests:

Manufacturing process:                      Solid dimethylhydantoin (DMH) is dissolved in water with bromine and chlorine.  The reaction is 0.5 mole bromine and 1.5 mole chlorine for one mole DMH.  During the reaction the pH is kept basic by the addition of caustic soda.  The wet product is transferred to a drier where it is dried to a powder at low temperature.  The powder may then be tableted or granulated.

Assay:

Procedure:                                        Various analytical methods exist for analysis, namely, GLC, HPLC, UV and NMR.  HPLC offers the best sensitivity.

 

[8.2]       inserting immediately after Testing Requirements for Nucleotides – Item 9 Bacteriological profile, the following

 

Specification for phytosterol esters derived from vegetable oils

 

Phytosterol esters are phytosterols derived from edible vegetable oils esterified with long-chain fatty acids derived from edible vegetable oils. 

 

Phytosterol esters + free phytosterols (%)        min.        94

Free phytosterols (%)                                      max. 10

Steradienes (%)                                               max.       0.3

Fatty acid methylester (%)                               max.       0.5

Iron, Fe (ppm)                                                 max.       1.0

Copper, Cu (ppm)                                           max.       0.5

Moisture (%)                                                   max.       0.1

Trans fatty acids (%)                                        max.       1.0

Sterol profile (%) as below -

Cholesterol                                                      min.        0.0         max.       2.0

Brassicasterol                                                  min.        0.0         max.       6.0

Campesterol                                                    min.        20.0       max.       29.0

Campestanol                                                   min.        0.0         max.       6.0

Stigmasterol                                                     min.        12.0       max.       23.0

β-Sitosterol                                                     min.        42.0       max.       55.0

β-Sitostanol                                                     min.        0.0         max.       2.5

D5-Avenasterol                                               min.        0.0         max.       4.0

D7-Stigmastenol                                              min.        0.0         max.       2.0

D7-Avenasterol                                               min.        0.0         max.       2.0

Other                                                              min.        0.0         max.       6.0

 

[9]          Standard 1.5.1 is varied by deleting the Table to clause 2, substituting –


Table to clause 2

 

Column 1

Column 2

Novel Food

Conditions of Use

phytosterol esters

The requirements in clause 2 of Standard 1.2.3.

 

The name ‘phytosterol ester or plant sterol esters’ must be used when declaring the ingredient in the ingredient list, as prescribed in Standard 1.2.4.

 

May only be added to food -

 

(1) according to Standards 1.3.4 and 2.4.2; and

 

(2) where the total saturated and trans fatty acids present in the food is no more than 28% of the total fatty acid content of the food.

 

[10]        Standard 2.4.2 is varied by inserting immediately after paragraph 2(1)(f), the following –

 

              (g)          no more than 137 g/kg of phytosterol esters.