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 A1125 which seeks to permit the use of the enzyme endo ß(1,4) xylanase produced by genetically modified (GM) Bacillus subtilis that contains a xylanase gene sourced from Pseudoalteromonas haloplanktis as a processing aid. The Authority noted that it is to be used in the manufacture of bakery and other cereal-based products. 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, 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 the use of the enzyme endo ß(1,4) xylanase, produced by genetically modified B. subtilis that contains a xylanase gene sourced from P. haloplanktis as a processing aid for use in the manufacture of bakery and other cereal-based products.
This requires an addition to the table to subsection S18––9(3) in Schedule 18.
3. Documents incorporated by reference
The variation to food regulatory measures does 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 A1125 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 23 January 2017 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Standard 18 are likely to have a minor 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 subsection S18––9(3) in Schedule 18. The new entry permits the use of the enzyme endo ß(1,4) xylanase (EC number 3.2.1.8), produced by GM B. subtilis that contains a xylanase gene sourced from Pseudoalteromonas haloplanktis as a processing aid in food. Its technological purpose is use in the manufacture of bakery and other cereal-based products.
Overview
The Food Standards Australia New Zealand Act 1991 was enacted to establish Food Standards Australia New Zealand (FSANZ) and to set out its functions and procedures, primarily aimed at ensuring food safety and public health through the development of food standards. The legislation addresses the need for a cohesive and scientifically-backed framework for food regulation across Australia and New Zealand. Enacted by the Australian Parliament, the FSANZ Act aims to provide a unified approach to food regulation, ensuring consistency and reliability in food standards. The Authority, under this Act, has the responsibility to develop and vary food standards, taking into consideration public health, safety, and socio-economic impacts. The Act’s framework enables FSANZ to respond to emerging scientific evidence and technological advancements in food processing, ensuring that food standards remain current and effective.
Scope and Application
The legislation outlined pertains to the approval and variation of food regulatory measures under the Food Standards Australia New Zealand Act 1991. This Act empowers Food Standards Australia New Zealand to develop and vary standards within the Australia New Zealand Food Standards Code, subject to the procedures outlined in the Act. Specifically, this legislative instrument addresses the approval of a processing aid, the enzyme endo ß(1,4) xylanase, produced by genetically modified Bacillus subtilis containing a xylanase gene sourced from Pseudoalteromonas haloplanktis, for use in the manufacture of bakery and other cereal-based products. This variation is intended to be incorporated into the Code by amending subsection S18–9(3) in Schedule 18. The Authority’s decision follows a round of public consultation and aligns with the statutory requirements under Division 1 of Part 3 of the FSANZ Act. The legislative instrument does not incorporate any documents by reference, and it is exempt from the need for a Regulation Impact Statement and a statement of compatibility with human rights due to its minor impact on business and individuals. Furthermore, the instrument is a legislative instrument under section 92 of the FSANZ Act and is not subject to parliamentary disallowance or sunsetting.
Key Provisions
The main sections of the legislation concern the approval and publication of a draft standard regarding the use of a specific enzyme in food manufacturing. Under section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), the Authority has the function of developing and varying food standards, including the approval of processing aids. The Authority accepted Application A1125, which sought permission for the use of the enzyme endo ß(1,4) xylanase, produced by genetically modified Bacillus subtilis containing a xylanase gene sourced from Pseudoalteromonas haloplanktis, as a processing aid in bakery and cereal-based products. After considering the application, the Authority approved a draft Standard in accordance with the FSANZ Act and subsequently published a notice under section 92 of the Act. This draft standard is now subject to further review by the Australia and New Zealand Ministerial Forum on Food Regulation before it becomes a legislative instrument.
The obligations imposed by this legislation on the relevant parties are primarily focused on compliance with the newly approved draft standard. The Authority must ensure that the enzyme endo ß(1,4) xylanase is used in accordance with the technological purpose outlined in the draft standard, which is its use in the manufacture of bakery and cereal-based products. Additionally, the Authority is obligated to publish the notice regarding the draft standard and to undertake public consultation as stipulated in Division 1 of Part 3 of the FSANZ Act. Any entities or individuals involved in the production or use of bakery and cereal-based products must adhere to the conditions set out in the draft standard, ensuring that the enzyme is used appropriately and within the scope of its approved application.
Breach of the provisions set out in this legislation may lead to various consequences. While the explanatory statement does not detail specific offences or penalties, the FSANZ Act generally provides for enforcement mechanisms to ensure compliance. Violations of food standards or variations thereof can result in civil or criminal penalties depending on the nature and severity of the breach. Under the FSANZ Act, enforcement actions may include fines, court orders, or other remedies to rectify non-compliance. The maximum penalties for breaches of food standards can be substantial, reflecting the importance of food safety and integrity. It is therefore crucial for all parties to fully understand and comply with the approved draft standard to avoid potential legal repercussions.