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.
The Authority accepted Application A1098 which seeks to approve a new 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 Standard.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[1], 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 Legislative Instruments Act 2003.
2. Purpose
The Authority has approved chymotrypsin produced by a genetically modified microorganism, B. licheniformis containing the gene for serine protease (chymotrypsin) from N. prasina. This requires an addition to the Table to clause 17 (Permitted enzymes of microbial origin) in Standard 1.3.3 – Processing Aids. 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.
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 A1098 included one round of public consultation following an assessment and the preparation of a draft Standard 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 proposed variations to Standard 1.3.3 are likely to have a minor but beneficial 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
The variation inserts a new entry into the Table to clause 17 of Standard 1.3.3. The new entry will permit the use of chymotrypsin (EC 3.4.21.1) from a genetically modified form of the microorganism B. licheniformis, containing the genes for chymotrypsin from N. prasina, as a processing aid in the production of food.
[1] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991, enacted by the Australian Parliament, establishes Food Standards Australia New Zealand (FSANZ) to develop and manage food standards in Australia and New Zealand. This Act aims to ensure food safety and public health by providing a framework for the creation and maintenance of food standards. The legislation empowers FSANZ to consider applications for the development or variation of food regulatory measures, including standards, and mandates public consultation processes. The Act addresses gaps in food regulation by creating a unified approach to food standards across both countries, ensuring consistency and safety in food production and processing. In line with these objectives, the Authority has approved a new enzyme, serine protease (chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis as a processing aid, subject to ministerial forum review and public consultation. This approval is reflected in an amendment to Standard 1.3.3 – Processing Aids, allowing the use of the specified enzyme in food production.
Scope and Application
The legislation, F2015L01220, applies to the process of approving a new enzyme, serine protease (chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis containing the genes for chymotrypsin from Nocardiopsis prasina, for use as a processing aid in food production. This legislation is enacted under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), and the Authority responsible for its development is Food Standards Australia New Zealand (FSANZ). The application process and subsequent approval follow the procedures outlined in Division 1 of Part 3 of the FSANZ Act, including public consultation. The approved enzyme, chymotrypsin, is to be added to the Table in clause 17 (Permitted enzymes of microbial origin) of Standard 1.3.3 – Processing Aids in the Australia New Zealand Food Standards Code. This addition is intended to permit the use of the specified genetically modified enzyme in food processing. The legislation does not incorporate any documents by reference and exempts 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 geographic reach of this legislation is national, applying to both Australia and New Zealand.
Key Provisions
The key provisions of this legislation, as outlined in the Explanatory Statement, revolve around the approval of a new enzyme, serine protease (chymotrypsin), for use as a processing aid in food production. Section 13 of the FSANZ Act (Food Standards Australia New Zealand Act 1991) establishes the Authority's role in developing and varying food standards, which is exercised through the acceptance and consideration of applications such as Application A1098 (paragraph 1). The Authority, after conducting its review and considering public feedback, has approved a draft Standard, which must subsequently be published as per section 92 of the FSANZ Act. The approved enzyme, chymotrypsin, produced by a genetically modified strain of Bacillus licheniformis, is intended to be added to the list of permitted enzymes in Standard 1.3.3 – Processing Aids. This addition is detailed in the variation, which inserts a new entry into the Table to clause 17 of Standard 1.3.3, as outlined in paragraph 6.
The obligations imposed by this legislation on the parties governed by it include adherence to the newly approved food regulatory measures. For entities using chymotrypsin as a processing aid, compliance with the newly established Standard 1.3.3 is mandatory. This means that only chymotrypsin derived from the specified genetically modified strain of B. licheniformis can be used in food processing. Furthermore, the Authority’s process for considering and approving such applications involves a round of public consultation, ensuring that stakeholders have an opportunity to provide input before the draft Standard is finalised.
In terms of penalties and consequences for non-compliance, the legislation does not explicitly detail specific offences or penalties for breaches of the new Standard. However, it is implied that non-compliance with food regulatory measures approved by the Authority could lead to enforcement actions by regulatory bodies. Given that the legislative instrument is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003 (as per section 94 of the FSANZ Act), the approved Standard remains in force unless otherwise amended by the Authority. The absence of a Regulation Impact Statement suggests that the impact of the approved variation is considered minor, but any deviation from the stipulated standards could still result in regulatory scrutiny and potential corrective measures.