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 A1174, which seeks permission to use endo-1,4-beta-xylanase from a genetically modified strain of Trichoderma reesei as a processing aid in the manufacture of bakery products and other cereal-based products, including cereal-based beverages. The Authority considered the application in accordance with Division 1 of Part 3 and has approved 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 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 Legislation Act 2003.
2. Purpose
The Authority has approved an amendment to the table to subsection S18––9(3) in Schedule 18 of the Code to permit the use of endo-1,4-beta-xylanase from a genetically modified strain of Trichoderma reesei as a processing aid in the manufacture of bakery and other cereal-based products, including cereal-based beverages.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the processing aid to be permitted by the draft variation. Section 1.1.1—15 of the Code requires substances used as processing aids to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2017) and the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition). These include specifications for enzyme preparations used in food processing.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1174 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 24 September 2019 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from needing to develop a Regulatory Impact Statement for proposed variations of the Code to permit additional processing aids (OBPR correspondence dated 24 November 2010 - reference 12065). This standing exemption was provided as permitting additional processing aids is likely to have only a minor impact on business and individuals. It is a minor, deregulatory change that allows for the introduction of a processing aid to the food supply that has been determined to be safe. The use of the approved processing aid is also voluntary.
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 subsection S18—9(3) in Schedule 18.
The new entry would permit the use of endo-1,4-beta-xylanase (EC 3.2.1.8) sourced from Trichoderma reesei containing the endo-1,4-beta-xylanase gene from Aspergillus niger as a processing aid.
The specific technological purpose for the permission is the manufacture of bakery and other cereal-based products, including cereal-based beverages.
A condition of the permission is that the maximum permitted level or amount that may be used must be consistent with good manufacturing practice.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide a framework for the regulation of food standards and food labelling across Australia and New Zealand. This Act was introduced to address the need for a unified approach to food safety and quality standards between the two countries. Food Standards Australia New Zealand (FSANZ), the body established under this Act, is responsible for developing food standards and ensuring compliance with these standards. In line with the Act, FSANZ accepted an application seeking permission to use endo-1,4-beta-xylanase from a genetically modified strain of Trichoderma reesei as a processing aid in the manufacture of various cereal-based products. Following a public consultation and assessment, FSANZ approved a draft variation to the Australia New Zealand Food Standards Code. The policy objective is to allow the safe and voluntary use of the enzyme as a processing aid, ensuring it complies with established identity and purity specifications.
Scope and Application
The F2020L00568 legislation pertains to the approval of a draft variation to the Australia New Zealand Food Standards Code (Code) concerning the use of endo-1,4-beta-xylanase from a genetically modified strain of Trichoderma reesei as a processing aid in the manufacture of bakery products and other cereal-based products, including cereal-based beverages. This Act applies to entities involved in the food manufacturing industry, particularly those producing bakery and cereal-based products. The geographic reach of this legislation is national, as it involves both Australian and New Zealand standards set by Food Standards Australia New Zealand (FSANZ). The Act does not apply to other industries or unrelated conduct outside the scope of food production and regulation. The legislation is a minor, deregulatory change that facilitates the voluntary use of a processing aid deemed safe, and is exempt from requiring a Regulatory Impact Statement due to its minor impact on business and individuals. The approved variation is a legislative instrument under section 94 of the FSANZ Act, exempt from parliamentary disallowance or sunsetting. The legislation does not incorporate any documents by reference but references existing provisions in the Code that incorporate specifications from the Joint FAO/WHO Expert Committee on Food Additives Compendium of Food Additive Specifications and the United States Pharmacopeial Convention Food Chemicals Codex.
Key Provisions
The primary operative sections of this legislation are sections 13, 92, and 94 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 details the Authority's function to develop standards and variations for inclusion in the Australia New Zealand Food Standards Code (Code). Section 92 mandates that the Authority publish a notice about the standard or draft variation of a standard. Section 94 clarifies that such standards or variations, once noticed, are legislative instruments but are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. In practice, this means that the Authority can amend the food standards code to include new or modified standards without the need for parliamentary approval.
The Act imposes several obligations on the Authority and other parties it governs. Firstly, the Authority must accept applications for the development or variation of food regulatory measures and consider them according to the stipulated procedures in Division 1 of Part 3 of the FSANZ Act. The Authority is also required to consult the public on draft variations, ensuring transparency and allowing for stakeholder input. Additionally, the Authority must publish a notice about any standard or draft variation of a standard, as specified in section 92 of the FSANZ Act. The use of the approved processing aid, endo-1,4-beta-xylanase from a genetically modified strain of Trichoderma reesei, must comply with good manufacturing practices and the specified maximum permitted levels.
The legislation outlines several potential consequences for breaches. Although the draft variation itself is a legislative instrument and not subject to parliamentary disallowance or sunsetting, non-compliance with the conditions set for the use of endo-1,4-beta-xylanase could lead to enforcement actions. Manufacturers using the processing aid must adhere to the specified maximum permitted levels and good manufacturing practices. Failure to do so might result in regulatory action, including fines or other penalties under the FSANZ Act or other relevant legislation. The exact penalties are not specified in this explanatory statement but would typically be determined based on the severity and frequency of the breach.
The explanatory statement does not explicitly detail any criminal offences associated with breaches of the variation. However, it implies that non-compliance with the conditions for using endo-1,4-beta-xylanase could lead to civil consequences, such as fines or other enforcement measures. The precise penalties would depend on the specific regulatory framework governing food safety and quality in Australia. Overall, the Act aims to ensure that any processing aid used in food manufacturing is safe and that its use is regulated to protect public health.