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.
FSANZ accepted Application A1111 which seeks approval for a preparation of two bacteriophages (S16 and FO1a) (tradename Salmonelex™) as a processing aid to reduce Salmonella contamination in specific foods. The Authority considered the Application in accordance with Division 1 of Part 3 and has proposed a draft variation.
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 proposed that Salmonella phage preparation (S16 and FO1a) be added to the list of approved processing aids with miscellaneous technological functions for use in specific foods. The table to section S18―9 in Schedule 18 lists permissions for these processing aids, as well as the foods and levels which are allowed. An entry for Salmonella phage preparation (S16 and FO1a) will be included for use on the surface of raw meat and raw poultry meat during processing at levels up to Good Manufacturing Practice (GMP). A specification stating what the preparation is composed of will also be included into Schedule 3.
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 A1111 included one round of public consultation following an assessment and the preparation of a draft variation and associated report.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 and Schedule 3 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
Item [1] varies Schedule 3.
Item [1.1] amends the table to subsection S3—2(2) by inserting a reference to Salmonella phage preparation (S16 and FO1a) and to new subsection S3—33. This in effect provides that the specification listed in new subsection S3—33 is the specification for Salmonella phage preparation (S16 and FO1a).
Item [1.2] new subsection S3—33 into Schedule 3. The new subsection provides a compositional specification for Salmonella phage preparation (S16 and FO1a) (S3—33) by reference to the biological classification of its component phages.
Item [2] varies Schedule 18 by amending the table to section S18―9 to include an entry for Salmonella phage preparation (S16 and FO1a) in the list of approved processing aids with miscellaneous technological functions. The new entry states that the phage preparation can be used for the technological purpose of reducing Salmonella species on the surface of raw meat and raw poultry meat during processing. The entry also states that the maximum permitted level is that which is consistent with GMP.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide a legislative framework for the development and administration of food standards in Australia and New Zealand. This Act addresses the need for a unified approach to food regulation across the two countries, ensuring public health protection and consumer confidence in the food supply. The FSANZ Act empowers Food Standards Australia New Zealand (FSANZ) to develop standards, including variations of standards, for inclusion in the Australia New Zealand Food Standards Code. The Act was introduced by the Parliament of Australia to streamline food regulatory measures and to ensure they are based on sound scientific evidence. FSANZ has proposed a draft variation to include a preparation of two bacteriophages (S16 and FO1a) as a processing aid to reduce Salmonella contamination in specific foods. This proposal follows a public consultation process and is intended to enhance food safety by allowing the use of this preparation on the surface of raw meat and raw poultry meat during processing, up to levels consistent with Good Manufacturing Practice (GMP). The variation seeks to amend Schedule 3 to include a compositional specification for the phage preparation and to amend Schedule 18 to list the preparation as an approved processing aid for reducing Salmonella species in specified foods.
Scope and Application
The proposed legislative instrument under the Food Standards Australia New Zealand Act 1991 pertains to the acceptance of Application A1111 which seeks the approval of a preparation composed of two bacteriophages (S16 and FO1a), marketed under the trade name Salmonelex™, as a processing aid designed to reduce Salmonella contamination in specific foods. This Act applies to Food Standards Australia New Zealand, the Authority responsible for developing and varying standards within the Australia New Zealand Food Standards Code. The application of the Act extends to entities involved in the food industry that are subject to these standards, including food manufacturers, processors, and suppliers within Australia and New Zealand. The proposed variation, if enacted, would allow the use of the Salmonella phage preparation on the surface of raw meat and raw poultry meat during processing at levels consistent with Good Manufacturing Practice. The geographic reach of this Act is national, covering both Australia and New Zealand. The legislation does not specify any exclusions, exemptions, or thresholds beyond what is detailed in the draft variation. The application of the Act may be further extended or specified through subordinate instruments, although this particular legislative instrument does not incorporate any documents by reference. The proposed variation is exempt from the requirements for a statement of compatibility with human rights due to its status as a non-disallowable instrument under section 94 of the FSANZ Act.
Key Provisions
The legislation F2016L00787 primarily addresses the variation of food regulatory measures in the Australia New Zealand Food Standards Code (the Code). Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) mandates that Food Standards Australia New Zealand (the Authority) develop and vary standards for inclusion in the Code. The Authority has accepted Application A1111, seeking approval for a bacteriophage preparation known as Salmonelex™ (comprising S16 and FO1a) as a processing aid to reduce Salmonella contamination in specific foods. The Authority's consideration of this application, as outlined in Division 1 of Part 3 of the FSANZ Act, has resulted in a proposed draft variation of the Code.
Under this Act, the Authority has the obligation to publish a notice about the standard or draft variation once the Australia and New Zealand Ministerial Forum on Food Regulation has reviewed it. This is stipulated in section 92 of the FSANZ Act. The draft variation, if implemented, would be considered a legislative instrument but would not be subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, as specified in section 94 of the FSANZ Act. This process ensures transparency and adherence to the established legislative framework governing food standards.
The proposed variation, detailed in Item [1], affects Schedule 3 by inserting a reference to the Salmonella phage preparation (S16 and FO1a) and incorporating a new subsection S3—33, which provides the compositional specification for this preparation. Item [1.2] of the variation also adds a new subsection S3—33 to Schedule 3, detailing the biological classification of the phages in the preparation. Furthermore, Item [2] amends Schedule 18 by adding an entry for the phage preparation in the list of approved processing aids, specifying its use on the surface of raw meat and raw poultry meat during processing and setting the maximum permitted level in accordance with Good Manufacturing Practice (GMP).
In terms of compliance, the Authority must adhere to the outlined procedures for accepting and considering applications for food regulatory measures, including the requirement for public consultation. This ensures that stakeholders have an opportunity to provide input on the proposed changes. The legislation does not incorporate any documents by reference, streamlining the process for understanding and applying the variations.
Failure to comply with the provisions of the FSANZ Act may result in legal consequences, although specific offences, penalties, or civil/criminal consequences are not detailed in the provided text. The focus remains on the procedural adherence to the Act and the regulatory measures' development to maintain food safety standards.