Food Standards (A1120 – Agarose Ion Exchange Resin as a Processing Aid for Lactoferrin Production) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01204 Not in force Legislative Instrument

Legislation content

Explanatory Statement

1. Authority

 

Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).

 

Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.

 

FSANZ accepted Application A1120 which seeks to permit an agarose ion exchange resin as a processing aid. The resin will be used in the production of high purity lactoferrin from bovine milk and milk-related products. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation to the Code.

 

Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the standard or draft variation of a standard.

 

Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.

 

2. Purpose

 

Ion exchange resins used in processing and manufacturing food are considered to be processing aids. Only those processing aids listed in Schedule 18 of the Code are permitted to be used in producing food sold in Australia and New Zealand. The Authority has proposed that the agarose ion exchange resin is permitted as a processing aid for lactoferrin production by adding this resin to the table to subsection S18––9(3) in Schedule 18.

 

Permissions for processing aids are also linked to their specification for identity and purity, provided in Schedule 3 of the Code. Since there are no specifications for the agarose ion exchange resin for lactoferrin production in any of the monographs in Schedule 3 (subsections S3—2 and S3—3), a new specification will be written into Schedule 3.

 

3. Documents incorporated by reference

 

The approved draft variation incorporates a specification by reference to a specific document in force or existing at the commencement of the variation.

 

The incorporated specification is an extraction regime described in the 2014 compilation of the United States Code of Federal Regulation. The latter is referred to in order to provide technical detail required to support the provisions of the Code. This reference by incorporation is consistent with the current practice in the Code, particularly Schedule 3 which itself already incorporates the same document by reference.

 


4. Consultation

 

In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1120 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. A call for submissions (including the draft variation) occurred for a six-week consultation period.

 

A Regulation Impact Statement was not required because the proposed variation to Schedule 18 and Schedule 3 is likely to have a minor impact on business and individuals.

 

5. Statement of compatibility with human rights

 

This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act.

 

6. Variation

 

6.1 Variation to Schedule 3

 

Item [1] varies Schedule 3.

 

Subitem [1.1] omits the words ‘agarose ion exchange resin’ from the table to subsection S3—2(2), and substitutes those words with ‘amine agarose ion exchange resin’.

 

Subitem [1.2] inserts a reference to ‘sulphonate agarose ion exchange resin’ into the table to subsection S3—2(2) in alphabetical order, together with a reference to the provision that sets a specification for that substance (‘section S3—34’).

 

Subitem [1.3] omits the words ‘agarose ion exchange resin’ from the heading to section S3—6, and substitutes those words with ‘amine agarose ion exchange resin’.

 

Subitem [1.4] inserts new section S3—34, which sets a specification for a sulphonate agarose ion exchange resin. The new section is numbered S3—34 to take account of another variation which will insert section S3—33 into Schedule 3.

 

6.2 Variation to Schedule 18

 

Item [2] varies Schedule 18.

 

Subitem [2.1] omits the definition of ‘agarose ion exchange resin’ in subsection S18—9(2).

 

Subitem [2.2] inserts in subsection S18—9(2), in alphabetical order, definitions for the following terms used in section S18—9:

 

  • ‘amine agarose ion exchange resin’; and
  • ‘sulphonate agarose ion exchange resin’.

 

Subitem [2.3] omits the words ‘Agarose ion exchange resin’ from the table to subsection S18—9(3), and substitutes those words with ‘Amine agarose ion exchange resin’.

 

Subitem [2.4] inserts in the table to subsection S18—9(3), in alphabetical order, a new entry for ‘Sulphonate agarose ion exchange resin’. The effect of this amendment is that sulphonate agarose ion exchange resin is permitted as a processing aid where:

 


  • its technological purpose is the production of lactoferrin from bovine milk and milk-related products; and
  • its maximum levels are consistent with good manufacturing practice (GMP).

 

 

Overview

The legislative instrument F2016L01204, enacted in 2016, addresses a specific gap in the Food Standards Australia New Zealand Act 1991 (FSANZ Act) concerning the use of processing aids in food production. This Act, enacted by the Australian Parliament, aims to safeguard public health and consumer protection by regulating the standards and variations of food standards in the Australia New Zealand Food Standards Code (Code). The legislative instrument proposes a variation to permit the use of an agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products, aligning with the FSANZ Act’s policy objective of ensuring food safety and maintaining the integrity of the food supply. The Authority's acceptance of the application and subsequent public consultation are consistent with the legislative framework outlined in Division 1 of Part 3 of the FSANZ Act, which mandates the consideration of such applications and public input.

Scope and Application

The explanatory statement outlines a legislative instrument pertaining to the Food Standards Australia New Zealand Act 1991. The Act applies to Food Standards Australia New Zealand (FSANZ), which is responsible for developing and varying standards for inclusion in the Australia New Zealand Food Standards Code. This particular instrument concerns an application to permit an agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products. Following the procedure outlined in Division 1 of Part 3 of the FSANZ Act, the Authority has prepared a draft variation to the Code, which includes updating the specifications for the resin in Schedule 3 and permitting its use in Schedule 18. The variation is intended to have a minor impact on business and individuals, hence a Regulation Impact Statement was not required. The instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act. The variation extends to Schedule 3 by specifying new resin types and their specifications and to Schedule 18 by defining new terms and permitting the use of the sulphonate agarose ion exchange resin as a processing aid under certain conditions.

Key Provisions

The key operative sections of the legislation detail the variation of the Australia New Zealand Food Standards Code (the Code) to permit the use of an agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products. Section 92 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) requires the Authority to publish a notice about the draft variation of a standard, while section 94 specifies that the standard is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The proposed variation is detailed in the explanatory statement and involves amending Schedule 3 and Schedule 18 of the Code. The obligations imposed by this Act on the parties or entities it governs primarily concern the adherence to the newly established standards and specifications for the agarose ion exchange resin. These specifications are intended to ensure the resin is used appropriately and safely in the production process. The Authority must ensure that all processing aids used in food production are listed in Schedule 18 of the Code, and that any specifications related to these aids are detailed in Schedule 3. The inclusion of the agarose ion exchange resin in Schedule 18 and the creation of a new specification in Schedule 3 are necessary steps to legally permit its use. Furthermore, any entity using this resin in food production must comply with the newly established specifications and adhere to good manufacturing practices as outlined in the Code. Breach of the provisions outlined in this legislation could result in civil or criminal consequences, although the exact penalties are not specified in the explanatory statement. Generally, under Australian law, violations of food safety and quality standards can lead to fines, legal action, and potential closure of operations if the breaches are severe. The specifics of any penalties would depend on the nature and severity of the breach, as well as any relevant state or territory legislation. The legislative instruments created by this Act are intended to uphold food safety standards and ensure consumer protection, so non-compliance could have serious ramifications for the entities involved. In summary, the legislation aims to formally permit the use of an agarose ion exchange resin as a processing aid in the production of lactoferrin, with detailed specifications and obligations for its use. It ensures that all processing aids are listed and specified within the Code, thereby maintaining high standards of food safety and quality. Any breaches of these provisions could lead to penalties, although the exact consequences would depend on the specific circumstances of the violation.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.