Food Standards (Application A1167 – Lactase from Bacillus subtilis as a PA (Enzyme)) Variation

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) serves to empower Food Standards Australia New Zealand (FSANZ) in developing and managing food standards across Australia and New Zealand. This Act was enacted to address the need for consistent and scientifically sound food standards, ensuring public health protection and facilitating trade. The Act outlines procedures for the development and variation of food standards, including mechanisms for public consultation and ministerial oversight. One of the key objectives of the FSANZ Act is to enable the FSANZ Authority to accept and consider applications for the development or variation of food regulatory measures, including standards. Following the consideration and approval of an application, such as application A1167, which seeks to permit the use of specific enzymes as processing aids in dairy processing, the Authority must publish a notice about the standard or draft variation of a standard, as mandated by section 92 of the FSANZ Act. The approved draft variation in this case pertains to the use of β-galactosidase enzyme sourced from Bacillus subtilis as a processing aid in the production of low lactose and lactose-free dairy products, subject to good manufacturing practices.

Scope and Application

The Act applies to Food Standards Australia New Zealand (the Authority) as it pertains to the development and variation of food regulatory measures, including standards, as per section 13 of the Food Standards Australia New Zealand Act 1991. The Authority's approval of the draft variation to permit the use of a β-galactosidase enzyme from Bacillus subtilis as a processing aid in dairy processing is a specific application of this legislative function. The geographic scope of this Act is national, affecting both Australia and New Zealand as outlined in the Australia New Zealand Food Standards Code. The application of this legislation is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, as specified in section 94 of the FSANZ Act. The draft variation, once finalised, will be incorporated into the Code and will apply to entities involved in dairy processing within the jurisdiction of both Australia and New Zealand.

Key Provisions

The key operative sections of the legislation, as outlined in the explanatory statement, involve the approval of a draft variation to the Australia New Zealand Food Standards Code (the Code) (section 92 and 94 of the FSANZ Act). Specifically, the legislation permits the use of a β-galactosidase enzyme sourced from Bacillus subtilis, containing the gene for β-galactosidase from Bifidobacterium bifidum, as a processing aid in the production of low lactose and lactose-free dairy products and galacto-oligosaccharides (subsection S18—9(3) in Schedule 18). The Authority has accepted and considered an application for this variation in accordance with the FSANZ Act (section 13), and following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, the Authority must publish a notice regarding the draft variation (section 92). This variation is a legislative instrument and is not subject to parliamentary disallowance or sunsetting (section 94). The obligations and requirements imposed by this Act on the parties or entities it governs include the acceptance and consideration of applications for variations to food regulatory measures, including standards, in accordance with the FSANZ Act (section 13). Additionally, the Authority must publish a notice about the standard or draft variation of a standard (section 92). The Authority has also included one round of public consultation following the assessment and preparation of a draft variation and associated assessment summary (Division 1 of Part 3 of the FSANZ Act). Existing provisions of the Code require substances used as processing aids to comply with relevant identity and purity specifications listed in Schedule 3 of the Code, which incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2016) and the United States Pharmacopeial Convention (2016) Food Chemicals Codex (10th edition) (section 1.1.1—15 and S3—2 of Schedule 3). There are no specific offences, penalties, or civil/criminal consequences for breach outlined in the explanatory statement. However, the draft variation is a legislative instrument and is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 (section 94). This means that the variation is legally binding and must be adhered to by relevant parties or entities. Failure to comply with the approved variation and the requirements of the FSANZ Act may result in regulatory action or other consequences as determined by the relevant authorities.