Food Standards (Application A1137 – Polysorbate 20 as a Food Additive) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01595 Not in force Legislative Instrument

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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 A1137 which sought to use polysorbate 20 as an emulsifier for processed meat and meat products, and processed fish and fish products. The Authority considered the application in accordance with Division 1 of Part 3 and has prepared a draft variation.

 

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

 

The Authority has approved the draft variation to amend the table to section S15—5 to permit the use of polysorbate 20 as a food additive on processed meat and meat products and on processed fish and fish products. The draft variation also amends the alphabetical and numerical listings in the table to section S8—2 to provide a name and code number for polysorbate 20 to be used for labelling purposes.

 

3. Documents incorporated by reference

 

The variations to food regulatory measures do not incorporate any documents 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 A1137 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 26 June 2018 for a four-week consultation period.

 

A Regulation Impact Statement was not required because the proposed variations to Schedule 15 are 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

 

Item [1.1]

 

Item [1.1] of the draft variation amends the alphabetical listing in the table to section S8—2 by inserting the food additive name ‘Polysorbate 20 or Polyoxyethylene (20) sorbitan monolaurate’ and code number ‘432’ into that listing in alphabetical order.

 

Item [1.2]

 

Item [1.2] amends the numerical listing in the table to section S8—2 by inserting the food additive code number ‘432’ and name ‘Polysorbate 20 or Polyoxyethylene (20) sorbitan monolaurate’ into that listing in numerical order.

 

Item [2.1]

 

Item [2.1] amends item 8.2 of the table to section S15—5. Item 8.2 relates to processed meat, poultry and game products in whole cuts or pieces. The amendment inserts into item 8.2 a reference to polyoxyethylene (20) sorbitan monolaurate (INS number 432), with a maximum permitted level of 500 mg/kg. The effect of the amendment is to permit that substance’s use as a food additive within that category of food products subject to that maximum permitted level.

 

Item [2.2]

 

Item [2.2] amends item 8.3 of the table to section S15—5. Item 8.3 relates to processed comminuted meat, poultry and game products, other than products listed in item 8.3.2. The amendment inserts into item 8.3 a reference to polyoxyethylene (20) sorbitan monolaurate (INS number 432), with a maximum permitted level of 500 mg/kg. The effect of the amendment is to permit that substance’s use as a food additive in that category of food products subject to that maximum permitted level.

 

Item [2.3]

 

Item [2.3] amends item 9.2 of the table to section S15—5. Item 9.2 relates to processed fish and fish products. The amendment inserts into item 9.2 a reference to polyoxyethylene (20) sorbitan monolaurate (INS number 432), with a maximum permitted level of 500 mg/kg. The effect of the amendment is to permit that substance’s use as a food additive in that category of food products subject to that maximum permitted level.

 

 

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide a legislative framework for the regulation of food standards in Australia and New Zealand. This legislation establishes Food Standards Australia New Zealand (FSANZ) as the authority responsible for developing food standards and regulatory measures, including variations to existing standards. The FSANZ Act aims to ensure the safety and quality of the food supply by setting and enforcing food standards and facilitating public consultation on proposed changes. FSANZ accepted application A1137, which sought to use polysorbate 20 as an emulsifier in processed meat, meat products, and fish and fish products. Following a review process and public consultation, the Authority has approved a draft variation to permit the use of polysorbate 20 as a food additive in these categories, subject to specific maximum permitted levels. This legislative instrument is not subject to parliamentary disallowance or sunsetting, as stipulated under the FSANZ Act.

Scope and Application

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) outlines the Authority's role in developing food standards, and this legislative instrument details a variation concerning the use of polysorbate 20 as an emulsifier for processed meat and meat products, and processed fish and fish products. This Act applies to Food Standards Australia New Zealand, the entities it regulates, and all industries involved with the production and sale of food products in Australia and New Zealand. The legislation specifies a maximum permitted level of 500 mg/kg for polysorbate 20 in the listed food categories, and it involves amending the relevant sections of the Australia New Zealand Food Standards Code. The Act does not incorporate any documents by reference, and it includes a single round of public consultation as part of its consideration process. 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.

Key Provisions

The operative sections of this legislation primarily pertain to the acceptance and variation of food regulatory measures, as outlined in sections 13 and 92 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 empowers the Authority to develop or vary food regulatory measures, while section 92 mandates that a notice be published once a standard or draft variation is prepared following the procedures in Division 1 of Part 3 of the FSANZ Act. These sections necessitate that any applications for variations to food standards, such as the use of polysorbate 20 as an emulsifier in processed meat and fish products, must be considered according to the stipulated procedures, including public consultation. The obligations imposed by this Act on the parties it governs are primarily administrative and procedural. The Authority must accept and consider applications for variations of food regulatory measures in accordance with the outlined procedures, including public consultation. The Authority is also required to publish a notice about the standard or draft variation of a standard, as per section 92 of the FSANZ Act. Additionally, the Authority must ensure that any amendments to the food standards, such as the use of polysorbate 20 in processed meat and fish products, comply with the procedural requirements and undergo appropriate consultation before final approval. There are no specific offences, penalties, or civil/criminal consequences outlined in this legislation for breach of the provisions. However, it is implied that any failure to comply with the procedural requirements or to publish notices as required could result in legal consequences. The FSANZ Act itself does not specify penalties for non-compliance, but breaches of legislative instruments can typically lead to enforcement actions under the broader legislative framework. For instance, non-compliance with food standards could potentially result in administrative penalties or legal action under related statutes such as the Australia New Zealand Food Authority Act 1991.

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Area of Law
Food Law
Instrument
Legislative Instrument
Concepts
Regulatory Standards
Reporting & Disclosure Obligations
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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.