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 A1091 which sought to update the Table to clause 17 of Standard 1.3.3 – Processing Aids to reflect the current naming and classification of carboxyl proteinase enzymes. The Authority has considered the Application in accordance with Division 1 of Part 3 of the FSANZ Act and prepared a draft variation to Standard 1.3.3.
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 draft 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 a draft variation to replace the carboxyl proteinase (EC 3.4.23.6) entry in the Table to clause 17 of Standard 1.3.3 with two new entries: Aspergillopepsin I (EC 3.4.23.18) and Aspergillopepsin II (EC 3.4.23.19). This variation updates the naming and classification for the enzymes previously permitted by carboxyl proteinase, so that they are consistent with the current recommendations of the International Union of Biochemistry and Molecular Biology.
The draft variation, along with an existing entry in the Table to clause 17 for mucorpepsin (EC 3.4.23.23), provides equivalent permissions for the use of enzyme processing aids as currently provided by carboxyl proteinase. The draft variation will place Aspergillus niger and A. oryzae into the microbiological sources column of Aspergillopepsin I, and A. niger into the microbiological sources column of Aspergillopepsin II, to ensure that the equivalent range of enzyme processing aids is permitted for use.
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 A1091 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. A call for submissions (including the draft variation) took place over a six-week consultation period
(3 June – 15 July 2014).
A Regulation Impact Statement (RIS) was not prepared because the proposed variation to Standard 1.3.3 is likely to have a minor impact on business and individuals. FSANZ consulted with the Office of Best Practice Regulation to confirm that a RIS was not required.
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 replaces the entry for carboxyl proteinase (EC 3.4.23.6) in the Table to clause 17 of Standard 1.3.3 with entries for Aspergillopepsin I (EC 3.4.23.18) and for Aspergillopepsin II (EC 3.4.23.19).
[1] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991 (the FSANZ Act) establishes the functions and procedures of Food Standards Australia New Zealand (FSANZ), including the development of food standards for the Australia New Zealand Food Standards Code (the Code). The Act was enacted to ensure food standards reflect contemporary scientific understanding and public health needs, thereby addressing the gap in the regulation of food safety and labelling standards. The FSANZ Act empowers FSANZ to accept applications for the development or variation of food regulatory measures, following specified procedures. This legislative framework was created by the Australian Parliament to provide a structured approach to the regulation of food standards. The explanatory statement for the draft variation of Standard 1.3.3 – Processing Aids, announced in 2014, outlines FSANZ’s response to Application A1091, which sought to update the Table to clause 17 of the Standard to reflect current enzyme classifications. This variation aims to align the naming and classification of carboxyl proteinase enzymes with the recommendations of the International Union of Biochemistry and Molecular Biology.
Scope and Application
The draft variation of Standard 1.3.3 – Processing Aids, as outlined in F2014L01624, applies to entities involved in the production, processing, or distribution of food products within Australia and New Zealand. This legislation specifically targets food regulatory measures and standards overseen by Food Standards Australia New Zealand (FSANZ), a body established under the Food Standards Australia New Zealand Act 1991. The variation seeks to update the Table to clause 17 of Standard 1.3.3, reflecting the current naming and classification of carboxyl proteinase enzymes in alignment with the International Union of Biochemistry and Molecular Biology's recommendations. This change ensures that enzyme processing aids permitted under the new names, Aspergillopepsin I and Aspergillopepsin II, are consistent with international standards and that the range of permitted enzymes remains unchanged. The geographic scope of this Act is limited to Australia and New Zealand, as per the jurisdiction of FSANZ. The application process involves public consultation, as mandated by the FSANZ Act, although a Regulation Impact Statement was deemed unnecessary due to the minor expected impact on businesses and individuals. This legislation does not incorporate any documents by reference and is exempt from the requirement for a statement of compatibility with human rights, being a non-disallowable instrument under section 94 of the FSANZ Act.
Key Provisions
The explanatory statement details the legislative process and rationale for updating the enzyme processing aids within Standard 1.3.3 of the Australia New Zealand Food Standards Code. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) mandates that Food Standards Australia New Zealand (the Authority) develops and varies food standards, as outlined in Division 1 of Part 3 of the FSANZ Act. This includes accepting applications for the development or variation of food regulatory measures and setting out the procedure for considering such applications. The Authority accepted Application A1091, which sought to update the enzyme classification in the Table to clause 17 of Standard 1.3.3. Following consideration, the Authority prepared a draft variation and published a notice about it, as required by section 92 of the FSANZ Act. This draft variation is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003, as per section 94 of the FSANZ Act.
The obligations imposed by this legislation include the Authority’s responsibility to consider applications for the development or variation of food standards and to follow the stipulated procedure, which involves public consultation. The Authority must also ensure that any proposed variations are consistent with current scientific recommendations and classifications, such as those from the International Union of Biochemistry and Molecular Biology. The Authority’s decision to update the enzyme classification in Standard 1.3.3, replacing carboxyl proteinase with Aspergillopepsin I and Aspergillopepsin II, reflects this obligation to align with contemporary scientific standards. Additionally, the Authority must publish a notice regarding draft variations, allowing for public feedback before final approval.
The explanatory statement outlines that no documents are incorporated by reference in this variation. Moreover, while a Regulation Impact Statement (RIS) was not prepared due to the minor impact of the proposed changes, the Authority consulted with the Office of Best Practice Regulation to confirm this decision. The statement also notes that a statement of compatibility with human rights is not required, as this instrument is exempt under section 94 of the FSANZ Act. The Authority’s adherence to these procedural requirements ensures transparency and public participation in the standard-setting process. Any breaches of these obligations or failure to follow the stipulated procedures could potentially result in legal challenges or disputes regarding the validity of the food standards. However, the explanatory statement does not detail specific penalties for non-compliance.