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 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
FSANZ prepared Proposal P1025 to revise the Code. The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved a draft revised Code.
Following consideration by the Legislative and Governance Forum on Food Regulation[1], 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 Legislative Instruments Act 2003.
2. Purpose
The Authority has approved variations of Chapters 1 and 2 of the Code.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference. The variations update some references to documents that are incorporated by reference.
4. Consultation
In accordance with the procedure in Subdivision F of Division 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1025 included two rounds of public comment following an assessment and the preparation of a draft Standard and associated reports. Submissions were called for on 23 May 2013 for a 12-week period, and on 10 July 2014 for an eight-week period.
A Regulation Impact Statement was not required, because the proposed variations to the Code 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
Schedule 6 – Required elements of a systematic review
Section S6—1 Name
Section S6—1 establishes that the instrument is the Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review.
Section S6—2 Required elements of a systematic review
Section S6—2 repeats Schedule 6 of Standard 1.2.7, which sets out the required elements of a systematic review.
[1] Previously known as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide for the establishment of Food Standards Australia New Zealand (FSANZ) and to set out its functions, which include the development and variation of standards in the Australia New Zealand Food Standards Code (the Code). The problem the Act aimed to address was the need for a cohesive and authoritative body to oversee and regulate food standards in Australia and New Zealand, ensuring public health and safety while also facilitating trade. The FSANZ Act allows for the preparation and consideration of proposals for the development or variation of food regulatory measures, which are then subject to a formal process involving public consultation. The policy objective, as outlined in the explanatory statement for the legislative instrument, is to approve variations to Chapters 1 and 2 of the Code to update and refine the required elements of a systematic review, enhancing the quality and reliability of food standards without imposing undue burdens on businesses or individuals.
Scope and Application
The legislation F2015L00476 pertains to Food Standards Australia New Zealand (FSANZ), an entity established under the Food Standards Australia New Zealand Act 1991. It applies to FSANZ and its functions related to the development, variation, and maintenance of the Australia New Zealand Food Standards Code. The Act governs the process by which FSANZ considers and proposes revisions to the Code, ensuring these are in line with regulatory requirements and public interest considerations. The Code itself applies broadly to food products and standards across Australia and New Zealand, affecting food businesses, manufacturers, and consumers within these jurisdictions. FSANZ's consideration of the draft revised Code includes mandatory public consultation periods, ensuring stakeholder input into the regulatory process. This legislation is exempt from parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003, and it does not incorporate any documents by reference but does update some existing references.
Key Provisions
The key sections of this legislation are sections S6—1 and S6—2, which establish the name of the instrument and detail the required elements of a systematic review respectively (sections 6 and 7 of the Explanatory Statement). Section S6—1 specifies that the instrument is titled the Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review. This section serves to identify and clarify the document as part of the broader Food Standards Code. Section S6—2, on the other hand, repeats Schedule 6 of Standard 1.2.7, which provides a comprehensive list of the required elements for conducting a systematic review. These elements are intended to ensure that reviews conducted under this provision are thorough, transparent, and meet the necessary standards for scientific and regulatory purposes.
The obligations and requirements imposed by this Act primarily concern the systematic review process outlined in the Code. The variations to the Code, as detailed in Schedule 6, necessitate that any systematic review conducted must adhere to the specified elements. These elements likely include criteria for the selection of studies, the methods for data collection and analysis, and the reporting standards to be followed. Such requirements are intended to ensure that systematic reviews undertaken within the framework of the Code are conducted in a rigorous and consistent manner. Additionally, the Act imposes a procedural obligation on the Authority to follow the stipulated process for considering proposals, including public consultations, before approving draft variations of the Code.
The legislation does not explicitly outline specific offences or penalties for breaches of the requirements set forth in the Code variations. However, any failure to comply with the mandated systematic review elements could potentially result in challenges to the validity or reliability of the review, which could have legal and regulatory consequences. These might include the need for additional reviews, the possibility of regulatory action against entities that do not adhere to the standards, and the potential for judicial review if the non-compliance affects statutory rights or obligations. The absence of specific penalties in the text suggests that the primary enforcement mechanism would be through the regulatory oversight and review processes inherent in the operation of the FSANZ Act.
The provisions in this legislation, particularly those related to systematic reviews, are integral to maintaining the integrity and reliability of food standards in Australia and New Zealand. By setting out clear requirements for how systematic reviews must be conducted, the Act ensures that the evidence base for food regulatory measures is robust and scientifically sound. This approach supports the Authority's role in protecting public health and ensuring consumer confidence in food safety standards. The procedural obligations, including public consultation, further enhance the transparency and inclusivity of the decision-making process, aligning with broader principles of good regulatory practice.