Australia New Zealand Food Standards Code – Transitional Variation 2015 (Application A1098 – Serine Protease (Chymotrypsin) as a Processing Aid (Enzyme))

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01227 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).

 

FSANZ had completed a review of the Code undertaken under Proposal P1025[1] in order to improve the Code’s clarity and legal efficacy. A revised Code has been approved and will commence on 1 March 2016. It will replace the existing Code, which will be repealed on that date.

 

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 A1098 which seeks to approve an enzyme, serine protease (chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis containing the genes for chymotrypsin from Nocardiopsis prasina as a processing aid.

 

The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation to Standard 1.3.3 of the existing Code.

 

The Authority has also approved a draft variation to Schedule 18 of the revised Code to ensure that, on 1 March 2016, the revised Code is consistent with the existing Code as amended by the draft variation.

 

Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[2], section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the draft variation.

 

Section 94 of the FSANZ Act specifies that 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 Legislative Instruments Act 2003.

 

2. Commencement

 

The approved variation to the revised Code takes effect on 1 March 2016. This is the date on which the existing Code is repealed and the revised Code comes into effect.

 

3. Purpose

 

The Authority has approved chymotrypsin (EC 3.4.21.1) produced by a genetically modified microorganism, B. licheniformis containing the gene for serine protease (chymotrypsin) from N. prasina. This requires the addition of a new entry into the table to subsection S18—4(5) in Schedule 18 of the revised Code. The nomenclature for the enzyme for inclusion in Standard 1.3.3 was determined as ‘chymotrypsin’ as this is consistent with the IUBMB naming system.


4. Documents incorporated by reference

 

The variations to food regulatory measures do not incorporate any documents by reference.

 

5. Consultation

 

In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1098 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 16 January 2015 for approximately a six-week consultation period.

 

A Regulation Impact Statement was not required because the Application is likely to have a minor but beneficial impact on business and individuals.

 

6. 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.

 

7. Variation

 

Item [1] of the Schedule to the Variation amends Schedule 18 of the revised Code by inserting a new entry into the table to subsection S18—4(5).

 

The new entry permits the use of chymotrypsin (EC 3.4.21.1) sourced from a genetically modified strain of Bacillus licheniformis containing the genes for chymotrypsin from Nocardiopsis prasina as a processing aid in the production of food.

 

 

[1] http://www.foodstandards.gov.au/code/proposals/Pages/proposalp1025coderev5755.aspx

[2] convening as the Australia and New Zealand Food Regulation Ministerial Council

Overview

The Food Standards Australia New Zealand Amendment Regulation 2015 (F2015L01227) was enacted to facilitate the inclusion of a new enzyme, chymotrypsin, in the Australia New Zealand Food Standards Code. This regulation was introduced to address the need for a revised and more legally effective Food Standards Code, following a comprehensive review by Food Standards Australia New Zealand (FSANZ) under Proposal P1025. The problem this legislation aimed to address was the need to update and clarify the existing food standards to better reflect current scientific understanding and regulatory requirements. Enacted by the Australian Government, the policy objective of this regulation is to ensure that food standards are both scientifically sound and legally robust, thereby protecting public health and safety. The regulation was developed in accordance with the Food Standards Australia New Zealand Act 1991 and includes a public consultation process to gather feedback and ensure transparency in the regulatory process.

Scope and Application

The legislation F2015L01227 pertains to the Food Standards Australia New Zealand Act 1991 and involves a variation to the Australia New Zealand Food Standards Code, specifically regarding the use of a genetically modified enzyme, serine protease (chymotrypsin), in food processing. The Authority, Food Standards Australia New Zealand (FSANZ), has approved the application to include this enzyme as a processing aid, which will be reflected in the revised Code effective from 1 March 2016. This Act applies to food processors, manufacturers, and entities involved in the food industry, ensuring they comply with updated standards for food safety and processing aids. The legislative variation is applicable across Australia and New Zealand, reflecting the trans-Tasman regulatory approach. Exemptions from parliamentary disallowance and sunsetting are specified under section 94 of the FSANZ Act, and the variation does not incorporate any documents by reference. Public consultation was conducted as part of the application process, and the impact on business and individuals is considered minor and beneficial.

Key Provisions

The main sections of this legislation focus on the approval and implementation of a variation to the Australia New Zealand Food Standards Code. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) outlines the Authority's role in developing standards and variations, while Division 1 of Part 3 specifies the process for considering applications for such variations. Section 92 mandates that the Authority must publish a notice about the draft variation, and section 94 clarifies that variations approved in this manner are legislative instruments but are not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003. The approved variation to the revised Code takes effect on 1 March 2016, which is also the date the existing Code is repealed and the revised Code comes into effect. The obligations imposed by this Act on the parties and entities it governs primarily revolve around the compliance with the new standards set forth in the revised Code. Specifically, entities involved in the production of food must adhere to the new entry in Schedule 18 of the revised Code, which permits the use of chymotrypsin produced by a genetically modified strain of Bacillus licheniformis as a processing aid. This requirement necessitates that food producers, processors, and other relevant stakeholders ensure that any use of chymotrypsin in their food production processes complies with the specifications outlined in the new entry. The Act does not explicitly outline specific offences or penalties for breaches of the new standards or variations in the revised Code. However, the FSANZ Act and related legislation generally provide mechanisms for enforcement and compliance, including the potential for administrative action, fines, or other penalties for non-compliance with food safety and quality standards. While the maximum penalties are not detailed in this particular legislative instrument, entities that fail to comply with the new standards could face regulatory scrutiny, fines, or other enforcement actions under broader food regulation frameworks. The legislative instrument includes a provision for public consultation, as mandated by Division 1 of Part 3 of the FSANZ Act. This ensures that stakeholders have the opportunity to provide feedback on the draft variation before it is finalised and implemented. The consultation process is designed to promote transparency and inclusivity in the development of food standards, allowing for public input to inform the Authority's decision-making. This is an important aspect of the legislative framework, ensuring that the interests and concerns of various stakeholders are considered in the development of food safety and quality standards. Additionally, the legislation notes that a Regulation Impact Statement was not required for this Application, as it is likely to have a minor but beneficial impact on business and individuals. This decision is consistent with the FSANZ Act's provisions, which allow for streamlined processes in cases where the anticipated impact is minimal. The exemption from the requirement for a statement of compatibility with human rights is also outlined, as the legislative instrument is a non-disallowable instrument under section 94 of the FSANZ Act. This ensures that the legislative process remains efficient while still upholding the necessary standards for food safety and quality.

Legal classification tags

Area of Law
Food Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Commencement Provisions
Consultation Requirements

Interactions

Authorises

All Versions

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.