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 A1136. It sought an amendment to the Code to permit the use of protein glutaminase from Chryseobacterium proteolyticum (C. proteolyticum) strain AE-PG as a processing aid to deamidate proteins during the manufacture and/or processing of baked products, and pasta/noodle making, milk and dairy processing, meat and fish processing, grain processing, yeast products and egg based 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 draft variation of a standard.
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 Legislation Act 2003.
2. Purpose
The purpose of this legislative instrument is to amend the Code to permit the use of the enzyme, protein glutaminase (EC 3.5.1.44) sourced from C. proteolyticum strain AE-PG as a processing aid to deamidate proteins during the manufacture and/or processing of foods such as baked products, pasta, noodles, milk, other dairy products, meat, fish, grains, yeast, and egg based products. This requires an addition to the table to subsection S18—9(3) in Schedule 18.
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 A1136 included one round of public consultation followed by an assessment and the preparation of a draft variation and associated assessment summary.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from needing to develop a Regulatory Impact Statement for the approval of additional processing aids, in a letter dated 24 November 2010 (reference 12065). This standing exemption was provided as permitting additional processing aids is a minor, deregulatory change and their use is voluntary. This standing exemption relates to the introduction of a food to the food supply that has been determined to be safe.
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] of the variation inserts a new entry into the table to subsection S18—9(3) in Schedule 18.
The new entry will, in effect, permit the enzyme, protein glutaminase (EC number 3.5.1.44), sourced from C. proteolyticum strain AE-PG, to be used as a processing aid in food for the particular technological purpose of deamidating proteins during the manufacture and/or processing of the following types of food, with the condition that the amount that may be used must be consistent with good manufacturing practice:
(a) baked products;
(b) pasta;
(c) noodles;
(d) milk;
(e) other dairy products;
(f) meat;
(g) fish;
(h) grains;
(i) yeast; and
(j) egg based products.
Overview
The legislative instrument in question amends the Australia New Zealand Food Standards Code to allow the use of protein glutaminase from Chryseobacterium proteolyticum strain AE-PG as a processing aid for deamidating proteins in various food types, including baked products, pasta, dairy, meat, and more. Enacted under the Food Standards Australia New Zealand Act 1991, this amendment responds to an application accepted by Food Standards Australia New Zealand (FSANZ). The legislation was introduced to address the need for updating food regulatory measures to accommodate safe and effective processing aids in the food supply. Enacted by the Australian Government, the policy objective of this instrument is to enhance food safety and quality by permitting the use of additional processing aids, following a public consultation and safety assessment process. This legislative instrument is a minor regulatory change and does not require parliamentary disallowance or a statement of compatibility with human rights, as it falls under the category of non-disallowable instruments as per section 94 of the FSANZ Act.
Scope and Application
The legislative instrument F2018L00578 amends the Australia New Zealand Food Standards Code to permit the use of the enzyme, protein glutaminase, sourced from Chryseobacterium proteolyticum strain AE-PG, as a processing aid for the specific purpose of deamidating proteins during the manufacture and/or processing of various food types including baked products, pasta, noodles, milk, dairy products, meat, fish, grains, yeast, and egg-based products. This amendment applies to entities and individuals involved in the food manufacturing and processing industries within the jurisdiction of the Australia New Zealand Food Standards Code, which covers both Australia and New Zealand. The application of this amendment is voluntary, and its use must be consistent with good manufacturing practice. The Authority, Food Standards Australia New Zealand, accepted the application and prepared the draft variation following consultation and assessment procedures outlined in the Food Standards Australia New Zealand Act 1991. The exemption from the need to develop a Regulatory Impact Statement for this minor, deregulatory change underscores the voluntary nature of its application. The instrument itself is not subject to parliamentary disallowance or sunsetting, aligning with the provisions of the Legislation Act 2003.
Key Provisions
The primary operative sections of the legislation (sections 13, 92, and 94 of the Food Standards Australia New Zealand Act 1991) establish the Authority's role in developing and varying food standards, the procedure for considering applications, and the publication of draft variations. Section 13 outlines the Authority's function to develop and vary standards within the Australia New Zealand Food Standards Code, while section 92 mandates the publication of notices regarding draft variations. Section 94 clarifies that these variations are legislative instruments but exempt from parliamentary disallowance or sunsetting under the Legislation Act 2003. The draft variation resulting from Application A1136 (FSANZ accepted Application A1136) proposes to amend the Code to allow the use of protein glutaminase from Chryseobacterium proteolyticum strain AE-PG as a processing aid in various food products.
The Act imposes several obligations on Food Standards Australia New Zealand (FSANZ). These include the requirement to consider applications for the development or variation of food regulatory measures, following the procedure outlined in Division 1 of Part 3 of the FSANZ Act. FSANZ must also publish a notice about any draft variation of a standard as stipulated by section 92 of the FSANZ Act. Additionally, the Authority must ensure that any new processing aids, such as the enzyme protein glutaminase, are safe for use in the food supply, and their use must comply with good manufacturing practices. The Office of Best Practice Regulation has exempted FSANZ from developing a Regulatory Impact Statement for this minor, deregulatory change due to its voluntary nature.
There are no specific offences or penalties outlined in the Explanatory Statement for breaches related to this legislative instrument. However, any failure to comply with the conditions specified for the use of the processing aid, such as not adhering to good manufacturing practices, could potentially lead to regulatory actions under other relevant sections of the FSANZ Act or other food safety legislation. The variations themselves are legislative instruments that are exempt from parliamentary disallowance or sunsetting, but they are subject to the general compliance requirements set out in the FSANZ Act.
The statement of compatibility with human rights is not required for this instrument as it is a non-disallowable instrument under section 94 of the FSANZ Act. This means that while the instrument itself is exempt from the need to provide a statement of compatibility, the process for developing and varying food standards must still ensure alignment with broader legal and regulatory frameworks, including those related to human rights. The legislation's focus is on ensuring the safety and quality of food products by permitting the use of specific processing aids, subject to certain conditions and good manufacturing practices.