Explanatory Statement
- 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 A1146, which sought an amendment to the Code to permit the use of thermolysin from Anoxybacillus caldiproteolyticus (A. caldiproteolyticus) strain TP-7 as a processing aid in protein, dairy, egg, meat and fish processing and flavour production. 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, thermolysin (EC 3.4.24.27) sourced from A. caldiproteolyticus strain TP-7 as a processing aid to catalyse the hydrolysis of peptide bonds during the manufacture and/or processing of foods such as: dairy, egg, meat, fish, protein, yeast, and flavouring. 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 A1146 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, thermolysin (EC number 3.4.24.27), sourced from A. caldiproteolyticus strain TP-7, to be used as a processing aid in food for the particular technological purpose of catalysing the hydrolysis of peptide bonds 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) dairy
(b) egg
(c) meat
(d) fish
(e) protein
(f) yeast, and
(g) flavouring.
Overview
The legislative instrument F2018L01445 was enacted under the Food Standards Australia New Zealand Act 1991 (FSANZ Act) to address the gap in the Australia New Zealand Food Standards Code (the Code) concerning the use of thermolysin from Anoxybacillus caldiproteolyticus strain TP-7 as a processing aid in various food processing applications. This legislative instrument was introduced by Food Standards Australia New Zealand (the Authority), following an application (Application A1146) that sought to amend the Code. The purpose of this legislative instrument is to permit the use of thermolysin, an enzyme sourced from A. caldiproteolyticus strain TP-7, as a processing aid to catalyse the hydrolysis of peptide bonds during the manufacture and/or processing of foods such as dairy, egg, meat, fish, protein, yeast, and flavouring. This amendment to the Code aims to enhance the technological capabilities in the food processing industry while ensuring the safety and quality of the food supply. The legislative process included one round of public consultation and was exempt from developing a Regulatory Impact Statement due to its minor, deregulatory nature and voluntary use.
Scope and Application
The legislative instrument F2018L01445 pertains to the Food Standards Australia New Zealand Act 1991 (FSANZ Act), which authorises Food Standards Australia New Zealand (FSANZ) to develop and vary standards within the Australia New Zealand Food Standards Code (the Code). This specific legislative instrument concerns the acceptance of Application A1146, which sought an amendment to the Code to permit the use of thermolysin from Anoxybacillus caldiproteolyticus strain TP-7 as a processing aid in various food industries, including protein, dairy, egg, meat, fish, and flavour production. The instrument, a non-disallowable legislative variation under section 94 of the FSANZ Act, is applicable to food manufacturers, processors, and other entities involved in the production of the aforementioned food types within the Australian and New Zealand jurisdictions. The amendment is not subject to parliamentary disallowance or sunsetting. The variation is designed to be incorporated into subsection S18-9(3) in Schedule 18 of the Code, thus allowing the specified enzyme to be used as a processing aid under certain conditions. The exemption from a Regulatory Impact Statement and the statement of compatibility with human rights underscores the minor deregulatory nature and safety of this change.
Key Provisions
The main operative sections of this legislative instrument pertain to the amendment of the Australia New Zealand Food Standards Code to allow the use of thermolysin from the bacterium Anoxybacillus caldiproteolyticus strain TP-7 as a processing aid (section 6). Specifically, item [1] of the variation introduces a new entry into the table of subsection S18—9(3) in Schedule 18, thereby permitting the use of this enzyme in the hydrolysis of peptide bonds during the manufacture and/or processing of various food types, including dairy, egg, meat, fish, protein, yeast, and flavouring. This inclusion is subject to the condition that its use must comply with good manufacturing practices (GMP).
The obligations imposed by this Act on the relevant parties include ensuring that the use of thermolysin adheres to the conditions specified within the amended Code. Manufacturers and processors who utilise thermolysin must do so in accordance with the stipulated good manufacturing practices, ensuring that the enzyme's application does not compromise food safety or quality. This requirement is vital to maintain the integrity and safety of the food supply chain and to ensure compliance with food regulatory standards.
In terms of consequences for non-compliance, the Act does not explicitly outline specific offences or penalties for breaches relating to the use of thermolysin as a processing aid. However, any failure to adhere to the good manufacturing practices or other relevant food safety regulations may result in regulatory action under broader food safety laws. These actions could include administrative penalties, enforcement actions, or legal proceedings if the breach is deemed significant enough to warrant such measures. The specific penalties would depend on the nature and severity of the breach and the applicable provisions of other relevant legislation.