Australia New Zealand Food Standards Code - Amendment No. 54 - 2001

Administered by Department of Health, Disability and Ageing

Legislation au F2008B00790 Not in force Legislative Instrument

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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.

Overview

The Australia New Zealand Food Authority Variations to the Food Standards Code (Amendment No. 54) was enacted to update the Food Standards Code, originally published by the National Health and Medical Research Council on 27 August 1987. This legislative instrument, published pursuant to section 32 of the Australia New Zealand Food Authority Act 1991, addresses the need to incorporate new specifications for certain food additives and ingredients into the Food Standards Code. The amendments were adopted by the Australia New Zealand Food Standards Council in March and June 2001. These variations aim to ensure the safety and quality of food by updating the standards and specifications for food additives, including the introduction of new substances such as bromo-chloro-dimethylhydantoin and phytosterol esters, and modifying existing standards to reflect current scientific knowledge and industry practices. The enactment of these variations was authorised by the Australia New Zealand Food Authority Act 1991, which established the Australia New Zealand Food Authority to administer and enforce food safety and quality standards across Australia and New Zealand. The policy objective of these amendments is to maintain and enhance the integrity of the food supply by ensuring that all food products comply with stringent safety and quality standards, thereby protecting public health and consumer confidence in the food industry. The variations introduced in Amendment No. 54 reflect ongoing efforts to adapt the Food Standards Code to new scientific findings and technological advancements in the food industry.

Scope and Application

The variations to the Food Standards Code set forth in this legislative instrument primarily affect the food industry, including food manufacturers, processors, and suppliers, within Australia. These amendments, pursuant to section 32 of the Australia New Zealand Food Authority Act 1991, introduce specifications and conditions for the use of certain additives, namely Bromo-chloro-dimethylhydantoin and phytosterol esters. The changes are applicable across the Commonwealth of Australia, impacting all food products that may contain these substances as ingredients or additives. The variations include specifications for the chemical properties and permissible levels of these additives in various food products, alongside labelling requirements to ensure consumer safety and informed choices. Additionally, the amendments extend to the conditions under which phytosterol esters can be added to food products, ensuring compliance with established standards and dietary guidelines. This legislative instrument does not specify any exclusions or exemptions but operates within the broader framework of the Food Standards Code, which may include provisions for threshold levels and subordinate instruments that further detail application and enforcement.

Key Provisions

The legislative instrument titled 'Variations to the Food Standards Code (Amendment No. 54)' includes a series of amendments to the existing Food Standards Code, which were published by the National Health and Medical Research Council. These amendments were adopted by the Australia New Zealand Food Standards Council and have been published in accordance with section 32 of the Australia New Zealand Food Authority Act 1991. The variations, which will be known as Amendment No. 54, commence on the date of their publication. The key sections of the amendment modify various standards within the Code, including Standards A11, A16, A19, G2, G5, 1.2.3, 1.3.3, 1.3.4, and 1.5.1. For example, Standard A11 is amended by inserting new specifications for a substance called bromo-chloro-dimethylhydantoin, which includes details such as its chemical formula, weight, appearance, and chemical properties. Similarly, Standard A19 is updated to include specific conditions for the use of phytosterol esters in food, ensuring they are only added in compliance with certain standards and limits on saturated fatty acids. Moreover, Standard G2 and G5 have been amended to include new permissible limits for the use of polyglycerol esters of fatty acids and phytosterol esters in food products. The obligations imposed by these amendments on parties and entities governed by the Code include strict adherence to the newly specified standards and conditions for the use of certain substances in food. For instance, manufacturers must ensure that bromo-chloro-dimethylhydantoin and phytosterol esters are used in accordance with the detailed specifications and limits outlined in the amended standards. There is also an obligation to label food products containing phytosterol esters with specific statements advising consumers on their consumption, especially highlighting that these products should not be consumed by infants, children, or pregnant or lactating women without medical supervision. Failure to comply with these variations may result in various civil or criminal consequences. While the specific penalties are not detailed within the text of the legislative instrument, breaches of food standards regulations in Australia generally attract significant penalties. These can include substantial fines and, in severe cases, criminal prosecution. The penalties can vary depending on the nature and severity of the breach, with repeat offenders often facing higher penalties. The specific enforcement mechanisms and penalties would be detailed in other relevant legislation or regulatory guidelines.

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