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. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
FSANZ prepared Proposal P1023 to, among other things, set a new commencement date for Standard 2.9.5 – Food for Special Medical Purposes.
The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved a draft variation to amend the commencement dates for Standard 2.9.5.
2. Purpose and operation
The Authority has approved a draft variation to commence Standard 2.9.5 on the date of gazettal of Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation with specific transitional arrangements until 28 June 2014. Standard 2.9.5’s earlier commencement date and the transition arrangements enable and provide greater regulatory certainty for stakeholders, particularly manufacturers of food for special medical purposes and enforcement agencies.
The variation was prepared as a separate legislative instrument having regard to its technical nature, that is, it actually varies the notice given under section 92 of the Food Standards Australia New Zealand Act 1991 for Standard 2.9.5 – Food for Special Medical Purposes (Federal Register of Legislative Instruments (FRLI) No. F2012L01347).
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 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1023 has included one round of public consultation following an assessment and preparation of a draft Standard and associated report. Submissions were called for on 2 October 2012 for a four-week consultation period.
A Regulation Impact Statement was not required because the proposed variations were administrative in nature and unlikely to have a negative 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. Variations
6.1 Variations
Item [1] of the Schedule varies the notice given under section 92 of the Food Standards Australia New Zealand Act 1991 for Standard 2.9.5 – Food for Special Medical Purposes (Federal Register of Legislative Instruments (FRLI) No. F2012L01347). The effect of this variation is to change the commencement date of Standard 2.9.5 to the date of gazettal of the Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation.
6.2 Commencement
Clause 2 of the amending instrument provides that it commences on the date of its gazettal.
Overview
The Food Standards Australia New Zealand Amendment (Food for Special Medical Purposes) Instrument 2013 (F2013L00253) was introduced to address the need for regulatory certainty regarding the implementation of Standard 2.9.5 – Food for Special Medical Purposes. Enacted by the Australian Government, this legislation amends the Food Standards Australia New Zealand Act 1991 to allow for a new commencement date for the aforementioned standard, facilitating smoother transitions for stakeholders, especially manufacturers and enforcement agencies. This amendment was developed following a proposal by Food Standards Australia New Zealand, which underwent a round of public consultation, ensuring that the interests of relevant parties were considered in the drafting process. The policy objective of this legislative instrument is to provide greater regulatory clarity and certainty for the industry by setting a definitive commencement date and establishing specific transitional arrangements.
Scope and Application
The legislation, F2013L00253, applies to Food Standards Australia New Zealand (FSANZ) and the entities responsible for manufacturing food for special medical purposes, as well as enforcement agencies that need to comply with and enforce the standards. The Act operates within the Commonwealth jurisdiction, aligning with the provisions of the Food Standards Australia New Zealand Act 1991. It specifically amends the commencement date for Standard 2.9.5, which pertains to food for special medical purposes, with a transitional period ending on 28 June 2014. This legislative instrument is exempt from the need for a statement of compatibility with human rights, as it falls under the category of non-disallowable instruments as per section 94 of the FSANZ Act. The variations outlined in this Act do not incorporate any external documents by reference and were developed following a round of public consultation, deemed necessary due to the administrative nature of the proposed changes.
Key Provisions
The legislation sets out the variations to the commencement date of Standard 2.9.5, which pertains to food for special medical purposes, as detailed in Item [1] of the Schedule (section 6.1). This variation changes the original commencement date of the standard to the date of gazettal of the Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation, effective immediately upon its publication (section 6.2). This change is designed to provide regulatory certainty for stakeholders, particularly those involved in manufacturing food for special medical purposes and enforcement agencies.
The Act imposes specific obligations on parties involved with food for special medical purposes, including manufacturers who must ensure compliance with the amended standard by the new commencement date. Enforcement agencies, such as food safety regulators, are required to monitor and ensure adherence to the updated regulatory requirements. Both parties must be aware of the transitional arrangements that extend until 28 June 2014, which provide a period for adaptation to the new standards.
Failure to comply with the provisions set out in this legislation can result in both civil and criminal consequences. For businesses, non-compliance may lead to enforcement actions, fines, and potential legal proceedings. Individual officers responsible for ensuring compliance may also face criminal charges, which can include significant penalties. The specific maximum penalties for breaches are not detailed in the explanatory statement, but they would typically align with those prescribed under the broader Food Standards Australia New Zealand Act 1991. These penalties may vary depending on the severity and frequency of the breach.